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Hansa Biopharma AB
549300LLEO25ZJJ3NT91 2022-01-01 2022-12-31 549300LLEO25ZJJ3NT91 2021-01-01 2021-12-31 549300LLEO25ZJJ3NT91 2022-12-31 549300LLEO25ZJJ3NT91 2021-12-31 549300LLEO25ZJJ3NT91 2020-12-31 549300LLEO25ZJJ3NT91 2021-01-01 2021-12-31 ifrs-full:IssuedCapitalMember 549300LLEO25ZJJ3NT91 2021-01-01 2021-12-31 ifrs-full:SharePremiumMember 549300LLEO25ZJJ3NT91 2021-01-01 2021-12-31 ifrs-full:TreasurySharesMember 549300LLEO25ZJJ3NT91 2021-01-01 2021-12-31 ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember 549300LLEO25ZJJ3NT91 2021-01-01 2021-12-31 ifrs-full:RetainedEarningsMember 549300LLEO25ZJJ3NT91 2021-01-01 2021-12-31 ifrs-full:EquityAttributableToOwnersOfParentMember 549300LLEO25ZJJ3NT91 2022-01-01 2022-12-31 ifrs-full:IssuedCapitalMember 549300LLEO25ZJJ3NT91 2022-01-01 2022-12-31 ifrs-full:SharePremiumMember 549300LLEO25ZJJ3NT91 2022-01-01 2022-12-31 ifrs-full:TreasurySharesMember 549300LLEO25ZJJ3NT91 2022-01-01 2022-12-31 ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember 549300LLEO25ZJJ3NT91 2022-01-01 2022-12-31 ifrs-full:RetainedEarningsMember 549300LLEO25ZJJ3NT91 2022-01-01 2022-12-31 ifrs-full:EquityAttributableToOwnersOfParentMember 549300LLEO25ZJJ3NT91 2020-12-31 ifrs-full:IssuedCapitalMember 549300LLEO25ZJJ3NT91 2020-12-31 ifrs-full:SharePremiumMember 549300LLEO25ZJJ3NT91 2020-12-31 ifrs-full:TreasurySharesMember 549300LLEO25ZJJ3NT91 2020-12-31 ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember 549300LLEO25ZJJ3NT91 2020-12-31 ifrs-full:RetainedEarningsMember 549300LLEO25ZJJ3NT91 2020-12-31 ifrs-full:EquityAttributableToOwnersOfParentMember 549300LLEO25ZJJ3NT91 2021-12-31 ifrs-full:IssuedCapitalMember 549300LLEO25ZJJ3NT91 2021-12-31 ifrs-full:SharePremiumMember 549300LLEO25ZJJ3NT91 2021-12-31 ifrs-full:TreasurySharesMember 549300LLEO25ZJJ3NT91 2021-12-31 ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember 549300LLEO25ZJJ3NT91 2021-12-31 ifrs-full:RetainedEarningsMember 549300LLEO25ZJJ3NT91 2021-12-31 ifrs-full:EquityAttributableToOwnersOfParentMember 549300LLEO25ZJJ3NT91 2022-12-31 ifrs-full:IssuedCapitalMember 549300LLEO25ZJJ3NT91 2022-12-31 ifrs-full:SharePremiumMember 549300LLEO25ZJJ3NT91 2022-12-31 ifrs-full:TreasurySharesMember 549300LLEO25ZJJ3NT91 2022-12-31 ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember 549300LLEO25ZJJ3NT91 2022-12-31 ifrs-full:RetainedEarningsMember 549300LLEO25ZJJ3NT91 2022-12-31 ifrs-full:EquityAttributableToOwnersOfParentMember iso4217:SEK xbrli:shares iso4217:SEK xbrli:shares
®
Pioneering
innovative
lifesaving
treatments
Annual Report 2022
1
Contents
The Swedish version of the 2022 Annual Report represents the legally binding version and prevails
7.
Shareholder information
8.
Directors’ report
9.
Financials
10. Governance
11. Remuneration
12. Glossary
1.
Overview
2.
Strategy
3.
Market
4.
Technology
5.
Growth
6.
New opportunities
Hansa Biopharma Annual Report 2022
Overview
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
Our vision
We envision a world
where all patients with
rare immunologic
diseases can lead long
and healthy lives
Hansa Biopharma (“Hansa”, “the Company”, “we”) is a
commercial-stage biopharmaceutical company pioneering the
development and commercialization of innovative, lifesaving
and life altering treatments for patients with rare
immunological conditions.
Hansa has developed a first-in-class immunoglobulin G (IgG)
antibody cleaving enzyme therapy, which has been shown to
enable kidney transplantation in highly sensitized patients.
Hansa has a rich and expanding research and development
program, based on the Company’s proprietary IgG-cleaving
enzyme technology platform, to address serious unmet
medical needs in transplantation, autoimmune diseases,
gene therapy and cancer.
Hansa Biopharma is based in Lund, Sweden,
and has operations in Europe and the U.S.
Hansa
Biopharma
in brief
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
Overview
2
Hansa Biopharma Annual Report 2022
Hansa Biopharma Annual Report 2022
3
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
Overview
4
Chairman’s letter
5
2022 highlights
6
CEO statement
8
Anticipated future milestones
Overview
1
Dear Shareholders,
2022 was another exciting and successful year
for Hansa Biopharma, with continued progress
and achievement of several key milestones in
both R&D and commercial operations. Despite
an unpredictable and challenging geopolitical
environment, we were able to pivot quickly to
meet unexpected operational demands, while
continuing to advance our key priorities.
I began my role as the Chairman of the Board of Directors at
Hansa Biopharma in June of 2022 and have been impressed
with the progress to date. Additionally, the entire organization
has demonstrated strong dedication and perseverance.
I remain impressed by the Company’s strong purpose-driven
culture and how colleagues across the organization work
together to deliver on our mission to develop innovative,
lifesaving and life altering therapies to patients with rare
conditions. It is a pleasure to now be part of this journey and
I look forward to continuing to work with the Board and the
leadership team while setting a strategic direction for Hansa
to advance its IgG-antibody cleaving technology platform
and products to the patients who need them.
During 2022, the Company set a strong foundation for the
commercialization of Idefirix
®
including successful market
reimbursement in four of the five largest markets in Europe.
This further validates the important role Idefirix
®
can play in
kidney transplantation. Additionally, several countries
consider Idefirix
®
a lifesaving and cost effective treatment
option. With the emergence of imlifidase, new international
consensus guidelines for a management pathway for kidney
transplant patients with high unmet need has been created.
The Company progressed several important phase 2 and 3
trials increasing the total number of programs in the clinic to
seven – a significant accomplishment for a company of this
size and a testament to our fierce commitment to advancing
our science and exploring the potential of our leading
technology platform.
Two new phase 3 programs were advanced including the
Post Approval Efficacy Study (PAES) of Idefirix in highly
sensitized kidney transplant patients and a global study in
anti-GBM disease. A phase 2 trial in antibody mediated
rejection (AMR) also moved ahead and the positive top line
data demonstrating statistically significant superiority
compared to current standard of care was communicated in
Q4 2022. Additionally, two pre-clinical projects progressed
– the NiceR program including our second-generation
antibody-cleaving enzyme candidate HNSA-5487 targeting
repeat dosing and a program in Duchenne Muscular
Dystrophy (DMD) in partnership with Sarepta. Both of these
programs will advance to clinical stage later this year.
2022 remained challenging for the technology and biotech
industries as a whole. The direct and indirect impact to
companies caused by rising interest rates, sector rotation and
geopolitical uncertainties, remain and have resulted in weak
valuations of many biotech companies. Despite this, the Board
was pleased with the successful execution of two financing
events last year. This enabled the Company to extend its cash
runway into 2025. With financing secured, a validated
technology platform with an exciting late-stage pipeline and a
highly engaged and committed organization, Hansa is
well-positioned to deliver on its strategic priorities in 2023 and
become a leading player in rare immunologic diseases.
On behalf of the Board of Directors,
Peter Nicklin
Chairman, Hansa Biopharma AB
Lund, Sweden, March 2023
Chairman’s letter
One immediately senses a strong
purpose driven culture among
the Hansa colleagues
Hansa Biopharma Annual Report 2022
4
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
Overview
2022 highlights
Agreement with AskBio to
evaluate feasibility of
imlifidase ahead of gene
therapy in Pompe disease
First patient enrolled in
the EU post approval
efficacy study (PAES)
Results of the Phase 2 study of
imlifidase in patients with anti-GBM
disease published in Journal of the
American Society of Nephrology
USD 70m non-dilutive
financing transaction,
extending Hansa’s cash
runway through 2024
Great Place to
Work
®
for third
consecutive year
Successful execution
of a directed share
issue of SEK 416m
(USD ~40m)
Completion of
preclinical work with
lead NiceR candidate
for repeat dosing
(HNSA 5487)
Announcement of
positive topline data from
the imlifidase phase 2
study in AMR
Market access granted in
France through a reimbursed
Early Access Program
Pricing and reimbursement
achieved for Idefirix
®
in Germany
Temporary marketing
authorization granted
in Switzerland
Poland Positive
reimbursement
decision for Idefirix
®
Pricing and
reimbursement granted
for Idefirix for use in Italy
ESOT guidelines
published in Transplant
International
Scotland Positive
reimbursement
decision for Idefirix
®
Pricing and reimbursement
granted for Idefirix for use in
Czech Republic
Announcement of plans to
initiate a clinical study with
imlifidase as a pre-treatment to
Sarepta’s SRP-9001 gene
therapy in DMD in 2023
NICE
recommends use
of Idefirix
®
Marketing authorization
in Israel for Idefirix
®
(imlifidase)
2022
2023
January
February
March
April
May
June
July
August
September
October
November
December
Hansa Biopharma Annual Report 2022
5
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
Overview
While the global geopolitical and financial environment made
2022 a very challenging year for the biotech sector overall, I
am very pleased with the solid performance and strong
progress across our R&D and commercial operations.
Commercial launch activities and market access efforts
for Idefirix
®
in Europe continued to progress as planned.
Importantly, by year-end 2022, commercial access had been
obtained in eleven European countries, including four of the
five largest markets: Germany, UK, Italy and France.
Additional market access procedures are ongoing in nine
countries, including Spain.
In August, the first medical guidelines for desensitization
treatment of highly sensitized kidney transplant patients were
published by the European Society for Organ Transplantation,
ESOT. These guidelines are the first to include Idefirix
®
and
represent the first international consensus on a management
pathway for kidney transplant patients with high unmet need.
The early publication of these guidelines underscores the
important role that Idefirix
®
can play as a new, transformative
therapy to enable kidney transplantation, and is an important
step in ensuring its use as a potential new “Gold Standard” in
desensitization protocols.
On the clinical development side, we continued to make
progress across our pipeline. In November, we presented
topline data from our phase 2 program in kidney transplant
AMR (post transplantation episodes or organ rejection),
demonstrating significantly superior capacity of imlifidase to
rapidly reduce donor specific antibodies (DSA) levels in
comparison to plasma exchange in the five days following the
start of the treatment.
During the year, we initiated two new phase 3 studies:
- the European Post Approval Efficacy Study in kidney
transplantation and the pivotal, global phase 3 study in
anti-GBM disease. Both studies will target 50 patients and
involve a significant number of clinics as we broaden our
experience with imlifidase to become a potential new
standard of care in both transplantation and acute
autoimmune diseases.
In the U.S., patient enrollment continues in our third ongoing
phase 3 study, the pivotal ConfIdeS trial in kidney
transplantation. The ConfIdeS study is evaluating imlifidase
as a potential desensitization therapy to enable kidney
transplants in highly sensitized patients waiting for a
deceased donor kidney through the U.S. kidney allocation
system. We expect to complete enrollment in the first half of
2023, while completion of randomization is expected in the
second half of this year. There has been strong interest from
leading transplantation centers to participate in this trial,
and we expect to initiate around 20 leading centers across
the U.S.
The enrollment in the phase 2 program in Guillain-Barré
Syndrome (GBS) was impacted by the COVID-19 pandemic
due to staff constraints in trial centers and a shortage of IVIg at
a subset of participating hospitals. We have worked to mitigate
these hurdles and saw an increase in patient enrollment at the
CEO statement
I am very pleased with the
solid performance and strong
progress across our R&D and
commercial operations
2022 was a successful year at Hansa,
with solid performance and strong
progress across the organization.
Søren Tulstrup
President and CEO,
Hansa Biopharma AB
Hansa Biopharma Annual Report 2022
6
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
Overview
end of 2022. A completion of enrollment in the GBS trial is
expected in the first half of 2023, with a top line data expected
in the second half 2023, as previously guided.
I am pleased with the achievements made in our preclinical
development programs, in particular in the Duchenne
Muscular Dystrophy (DMD) project with Sarepta Therapeutics
in gene therapy and the NiceR program, which is exploring
utilization of second-generation enzymes for repeat dosing.
In DMD, imlifidase is being investigated as a potential
pre-treatment in patients with pre-existing IgG antibodies to
Sarepta’s SRP-9001. To date, the data appears promising,
and plans have been announced to initiate a clinical study in
2023. In the NiceR program, we completed IND enabling
toxicology studies at the end of the year for our lead
candidate, HNSA-5487. A CTA approval has since been
obtained and we expect to begin a clinical trial in the first
half of 2023.
In addition, while the capital markets for biotech companies
remained challenging throughout 2022, I am pleased that we
were able to successfully secure additional financing through
two transactions last year, enabling us to extend our cash
runway into 2025. In July, we raised USD 70m through a
non-dilutive financing transaction with NovaQuest, and in
December we raised USD 40m in a directed share issue
targeting U.S. and other international healthcare specialist
investors. The funds raised will help finance preparations for
a potential U.S. launch of imlifidase in kidney transplantation
and further advance our exciting pipeline of drug candidates.
I am particularly grateful to our employees for their
commitment, passion, and hard work over the past year. We
are dedicated to building and maintaining a high-
performance team, while also creating a rewarding and
stimulating workplace for our employees. A clear reflection of
our successful efforts in this regard was the certification as a
Great Place to Work
®
for the third consecutive year.
At Hansa, sustainability is at the core of all we do, and during
2022 we continued to build on the formalized ESG framework
which was created in 2021. Embarking on this journey, we
have identified key objectives for our environmental, social
and governance priorities, which will be addressed separately
in our CSR Report.
We now have an exciting year ahead with several key
milestones across our platform and therapeutic areas as we
continue to pursue the development and launch of new,
transformative medicines that will enable patients with rare
immunologic diseases to lead long and healthy lives.
Søren Tulstrup
President and CEO,
Hansa Biopharma AB
Lund, Sweden, March 2023
CEO statement
continued
A clear reflection of our
successful efforts in this
regard was the
certification as a Great
Place to Work
®
for the
third consecutive year
Hansa Biopharma Annual Report 2022
7
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
Overview
Anticipated future milestones
Anti-GBM Phase 3:
First patient enrolled
(H1 2023)
HNSA 5487 (Lead NiceR candidate)
Initiate Phase 1 study
(H1 2023)
Long-term follow-up study
in kidney transplantation
5-year data readout
(H2 2023)
GBS Phase 2:
First data readout
(H2 2023)
U.S. Kidney transplantation
BLA submission
(2024)
GBS Phase 2:
Complete enrollment
(H1 2023)
U.S. Kidney transplantation:
Complete randomization
(H2 2023)
AMR Phase 2:
Full data readout (H2 2023)
U.S. Kidney transplantation:
Complete enrollment
(H1 2023)
Sarepta DMD pre-treatment:
Commence Clinical study
(2023)
2023
2024
Hansa Biopharma Annual Report 2022
8
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
Overview
Hansa Biopharma Annual Report 2022
9
10
Potential indication universe
12
Business model
13
Our strategic priorities
Overview
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
Strategy
2
Strategy
Hansa Biopharma Annual Report 2022
10
Overview
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
Strategy
Potential indication universe
1
The EU Commission has granted conditional approval for imlifidase in highly sensitized kidney transplant patients
2
In the U.S. a new study has commenced targeting a BLA filing by 2024
First generation antibody
cleaving enzyme technology
Obtained EU conditional approval
1,2
Planned clinical program
Clinical program
Research program
Opportunities currently not pursued
Partnership Preclinical program
(Sarepta Therapeutics Inc. and AskBio)
Transplantation and post transplantation
(Own commercial infrastructure in EU/U.S.)
Gene therapy pre-treatment
(Partnership opportunities)
...
Kidney
1,2
Pompe
disease
Limble
Girdle
(LGMD)
Kidney
AMR
Duchenne
(DMD)
First generation
antibody-cleaving
enzyme technology
Guillain
Barre
Syndrome
Anti-GBM
Acute autoimmune diseases
(Own commercial infrastructure in EU/U.S.)
New therapies
and oncology
Transplantation and
post transplantation
New enzymes
allowing repeat
dosing, “NiceR”
Other areas
Gene therapy
New therapies
and oncology
Relapsing
IgG-related
autoimmune
diseases
Lung
Heart
Lung
AMR
Heart
AMR
HCST
(Bone
Marrow)
Hansa’s first-generation antibody-cleaving
enzyme, imlifidase, is a protein with
properties that enable it to quickly and
effectively inactivate IgG antibodies.
Imlifidase is derived from the human
pathogen,
Streptococcus
pyogenes.
Imlifidase is being developed for the treatment and
prevention of diseases and conditions caused by IgG
antibodies in the acute phase, including desensitization
prior to kidney transplantation. The Company has
received conditional approval for marketing in Europe
for this indication.
We are also investigating the potential use of imlifidase
as a treatment of active antibody mediated rejection
(AMR) episodes in kidney transplantation and in solid
organ transplants, both pre- and post-transplantation
(e.g., heart and lung).
Looking beyond transplantation, there are several other
growth vectors and areas where imlifidase may play a role,
including acute autoimmune diseases, gene therapy and
oncology. More specifically, we are investigating rare
life-threatening conditions such as anti-GBM antibody
disease and Guillain-Barré Syndrome (GBS), which are both
ongoing clinical programs in phase 3 and 2 respectively.
In addition, Hansa, with its partners, is investigating
imlifidase as a pre-treatment to potentially enable gene
therapy in patients with pre-existing neutralizing antibodies
(NAbs) against the viral vectors used by the gene therapy.
Through the partnership with Sarepta Therapeutics,
imlifidase is being investigated in Duchenne Muscular
Dystrophy (DMD) and Limb-Girdle Muscular Dystrophy
(LGMD) and through the partnership with AskBio, a
subsidiary of Bayer AG, in Pompe disease.
Further, we are exploring potential indications within
oncology such as allogeneic HSCT. Stem cell
transplantation is a significant indication where, there is a
high unmet medical need for patients with high levels of
donor specific antibodies due to the current absence of
adequate desensitization methods.
Beyond imlifidase for the acute treatment in IgG mediated
conditions and diseases, we are also developing new
IgG-cleaving enzymes under the program “NiceR” (Novel
Immunoglobulin Cleaving Enzymes for Repeat Dosing).
These “next-generation” enzymes from the NiceR program
will be designed to have a lower propensity to induce
immunity in order to increase the therapeutic window. The
new enzymes are being developed to be potentially utilized
in several IgG-driven autoimmune diseases where patients
experience flares, or in transplantation where repeat dosing
would be beneficial and add further value. Following
completion of IND enabling toxicology studies late 2022 and
the subsequent approval of a Clinical Trial Application early
2023, Hansa expects to initiate a clinical trial during the first
half 2023 with HNSA-5487, its lead IgG-cleaving enzyme
candidate for repeat dosing.
Lastly, Hansa and argenx BV have been evaluating the
therapeutic potential of combining imlifidase and
efgartigimod, argenx’s FcRn antagonist. A combination of
imlifidase and efgartigimod or other FcRn antagonists
could potentially be used in both the acute and the
chronic setting of autoimmune diseases and
transplantation. Any potential next steps will be evaluated.
Potential indication universe
continued
Looking beyond transplantation, there
are several other growth vectors and
areas where imlifidase may play a role,
including acute autoimmune diseases,
gene therapy and oncology
Hansa Biopharma Annual Report 2022
11
Overview
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
Strategy
Business model
Leveraging a unique and proprietary technology platform to develop new
therapies in areas of high unmet medical need in rare disease
Revenue / sales
Upfront payments
Milestone payments
Royalties
Transplantation
Autoimmune diseases
Gene therapy
New therapies and oncology
Growth engine
Leveraging proprietary
antibody cleaving
enzyme technology
Value chain
Commercialization
Evolution into a fully integrated biopharmaceutical company
Own commercial
infrastructure
Partnership
strategy
Drug
discovery
Drug
development
Supply
operations
Distribution
Controlling the full value chain
Build-up of franchises
Indications and therapies
Multiple income streams
F(ab’)2
Fc
Hansa Biopharma Annual Report 2022
12
Overview
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
Strategy
partnerships and agreements. To date, we have a commercial
partnership with Medison Pharma in select countries in
Central Eastern Europe and Israel and strategic development
partnerships with AskBio and Sarepta Therapeutics in
gene therapy.
Hansa’s ambition is to become a leading player in rare disease
by expertly leveraging the Company’s unique and proprietary
antibody-cleaving enzyme technology platform and supporting
scientific and commercial innovation. The evolution to a fully
integrated biopharmaceutical company begins with the
technology platform – the growth engine of the current and
future pipeline. From discovery and development to
commercialization, the intention is to retain strategic control
and capture much of the economic upside generated.
There are four priority franchises within Hansa – autoimmune,
gene therapy, oncology and transplantation. Given the diverse
and complex nature of these four disease areas the Company
has employed an agile approach to commercialization. The
Company will leverage its strong commercial and medical
expertise in autoimmune and transplantation where we have
existing experience and relationships, and the customer base
is relatively concentrated. In complex disease areas or in
certain markets, the Company will consider strategic
*
Idefirix approved in EEA under conditional approval for kidney transplantation
Our strategic priorities
Hansa’s mission is to become a global leader in rare diseases through
the development of innovative, lifesaving and life altering treatments
for patients with rare immunological conditions
The Company’s strategy is anchored on the proprietary
enzyme technology platform and with a goal of developing
and commercializing immunomodulatory first-in-class or
best-in-class treatments for organ transplants, rare
IgG-mediated autoimmune conditions, and gene therapy, as
well as exploring the potential application of the technology
platform in oncology. To deliver on the ambition we have
three key priorities:
1. Commercialize
Idefirix
®
in first
indication and markets
2. Advance ongoing
imlifidase clinical
programs in
transplantation and
autoimmune diseases
3.
Expand IgG-cleaving
enzyme technology
platform into new
disease areas and
indications
Successfully launch Idefirix
®
in Europe*
Achieve market access in remaining
countries and ensure successful,
repeat and growing usage in
key clinics
Secure FDA approval and
launch Idefirix in the U.S.
Complete phase 3 study and
submit BLA under the accelerated
approval pathway
Geographical expansion
Explore opportunities to commercialize
Idefirix beyond core markets
Achieve approval/usage of
imlifidase in follow-on
indications
>
Anti-GBM
>
GBS
>
AMR
Explore gene therapy
opportunity
Develop imlifidase and other
enzymes as enablers and enhancers
of AAV-based gene therapies
through implementation of
development and commercialization
agreements with leading gene
therapy partners
Explore opportunities in
oncology/HSCT
>
Initiate trial in HSCT
>
Explore other indications through
partnerships
Develop next generation
IgG-cleaving enzymes
Initiate and complete clinical trial of
HNSA-5487
Build focused, integrated, agile and empowered international organization
and seek partnerships to accelerate growth and reduce risk
Hansa Biopharma Annual Report 2022
13
Overview
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
Strategy
1. Commercialize Idefirix
®
in first indication
and markets
In August 2020, Hansa received conditional approval from the
European Commission for Idefirix
®
(imlifidase) for the
desensitization treatment of highly sensitized adult kidney
transplant patients with positive crossmatch against an available
deceased donor.
We have launched Idefirix
®
in several major European countries
driving reimbursement and partnering closely with leading clinical
experts. In 2022, commercial access was obtained in eleven
European countries, including Germany, UK, France (through a
reimbursed Early Access Program) and Italy. We continue to
advance access and reimbursement in nine other countries
including Spain, Portugal, and Switzerland. Following completion of
our post-approval commitments, we will seek full approval from the
European Commission.
In the U.S. we have initiated ConfIdeS, a pivotal phase 3 study to
support the submission of a Biologics License Application (BLA).
The ConfIdeS trial is currently enrolling patients and the Company
expects to submit a BLA for accelerated approval in 2024. Given
that 10-15% of patients waiting for a kidney transplant in the U.S.
are considered highly sensitized, the approval and availability of
Idefirix
®
would be an important option for these patients.
Beyond Europe and the U.S., the Company is exploring commercial
opportunities for Idefirix in markets where the EMA approval can be
leveraged to gain approval and market access.
2.
Advance ongoing imlifidase clinical programs in
transplantation and autoimmune diseases
We have an ongoing clinical program in phase 2 in AMR and GBS as
well as we end of December 2022 initiated a pivotal phase 3 program
in
anti-GBM.
In active AMR, we are investigating imlifidase in acute and chronic acute
AMR episodes post kidney transplantation. Today there is no approved
drug in this indication. AMR episodes occur in 5-7%
1
of patients and is
a significant challenge to long-term graft survival.
In November, 2022, Hansa announced top-line data from the imlifidase
phase 2 study in AMR post kidney transplantation, demonstrating a
statistically significantly difference of imlifidase versus plasma
exchange to reduce levels of donor-specific antibodies (DSAs) in the
five days following treatment. The full data set is expected to be
announced in the second half of 2023.
We also have two ongoing clinical-stage programs in rare acute
autoimmune diseases – anti-GBM antibody disease and GBS. In
anti-GBM, we initiated a pivotal global phase 3 study at the first sites in
the U.S. end of December 2022 with the first patient expected to be
treated in the first half of 2023. Anti-GBM is an acute autoimmune
disease where antibodies are directed against an antigen intrinsic to the
glomerular basement membrane (GBM), causing acute injury of kidney
and/or lung function. Anti-GBM is an ultra-rare and very serious disease
that annually affects approximately 1.6 people per million worldwide.
In 2022 key data from the investigator-initiated phase 2 trial were
published in the Journal of American Society of Nephrology (JASN)
showing that two-thirds of patients achieved dialysis independence six
months after treatment with imlifidase, compared to typically two-thirds
of patients losing their kidney function and ending up on dialysis after
six months. The positive data from the phase 2 trial supported a new
pivotal study targeting 50 patients with anti-GBM disease across 30-40
sites in the U.S., U.K., and Europe.
We are also developing imlifidase for the treatment of GBS for which
we have an ongoing clinical program in phase 2 targeting 30 patients at
ten centers across the U.K., Netherlands and France. GBS is an acute
autoimmune attack on the peripheral nervous system, which affects
approximately 1 in 100,000 people
2
.
Completion of enrollment in the GBS trial is anticipated in the first half
of 2023 with a first high level data read-out expected in the second half
of 2023.
3.
Expand IgG-cleaving enzyme technology
platform into new disease areas and indications
As part of Hansa Biopharma’s platform strategy and objective to
broaden the application of imlifidase as a potential therapy to
change the course of IgG-mediated immunological diseases, the
Company has in recent years started to explore new therapeutic
areas, where our IgG antibody-cleaving enzyme technology platform
would have relevance to address indications with a high unmet
medical need indications both through Investigator-Sponsored Trials
(IST) programs and Hansa-Sponsored Trials.
In gene therapy, Hansa is working with two partners, Sarepta
Therapeutics and AskBio (Bayer AG) in three programs, namely
DMD, LGMD and Pompe disease, where imlifidase is being
evaluated as a potential pre-treatment to gene therapy in patients
with pre-existing neutralizing antibodies (NAbs) against adeno-
associated virus (AAV). Nabs against the AAV-based vector
commonly used in gene therapies remain a major challenge and
make these patients ineligible to receive gene therapy treatment.
We see significant potential for our antibody-cleaving enzyme
technology to help overcome this barrier.
Another major therapeutic area Hansa is looking into, is oncology,
where one of the key indications Hansa intends to explore further is
allogeneic hematopoietic stem cell transplantation (HSCT), also
known as “bone-marrow transplantation”. Anti-HLA antibodies
against the donor may prevent the successful engraftment of donor
cells in a patient requiring allogenic HSCT. Desensitization treatment
of patients with high levels of donor specific antibodies (DSA) prior
to allogeneic HSCT transplant is a challenge where imlifidase may
have the potential to transform the standard of care by enabling
clinicians to inactivate DSAs prior to transplantation, thus having the
potential to enable successful transplantation.
Lastly, we are aiming at developing next generation IgG-cleaving
enzymes with the objective of enabling repeat dosing across our four
franchises and where patients may benefit from more than one dose
of an IgG-modulating enzyme (e.g., dealing with flares). HNSA-5487
has been selected as our lead IgG-eliminating enzyme candidate
from the NiceR program. Following the completion of IND enabling
toxicology studies and a CTA, which subsequently was approved, it
is our intention to initiate a clinical trial for HNSA-5487 during the
first half 2023.
Our strategic priorities
continued
1
Puttarajappa et al., Journal of Transplantation, 2012, Article ID 193724
2
McGrogan et al., ”The Epidemiology of Guillain-Barré Syndrome Worldwide“, Neuroepidemiology;2009, 32(2):150-63
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16
Helping highly sensitized patients
who cannot access a kidney
18
Highly focused and sequenced launch strategy
20
Ongoing market access processes
21
Interview: Providing a new opportunity to a
growing number of highly sensitized patients on
kidney transplants lists
23
Interview: Building experience with imlifidase-
enabled kidney transplantations
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Market
3
Helping highly sensitized patients
who cannot access a kidney
The kidney transplantation landscape
According to the Global Observatory on Donation and
Transplantation there are approximately 170,000 patients in
the U.S. and Europe, alone, waiting for a new kidney.
However, given that organ availability continues to be a
limiting factor, only approximately 50,000 kidney transplants
are performed in these markets, of which, roughly 73% are
from deceased donors
1
.
During the last few years, transplantation and organ
donation rates in Europe experienced a significant decline,
mainly due to the pandemic, as the Covid-19 outbreak posed
unique challenges for both organ procurement and
transplantation, and the fact that a large number of
transplant centers would not allow the use of deceased
donor organs with evidence of previous infection or
exposure. The U.S. experienced less of a decline compared
to Europe due to a series of new initiatives implemented
including the acceptance of organs from a higher age group
than previously included, and from individuals who died of
cardiorespiratory failure.
A subgroup of kidney transplant patients, representing
between 10-15% of those waiting for kidney transplantation
1
,
are so-called highly sensitized. This means that these
patients are highly sensitized against potential donor tissues
due to prior exposure to foreign antigens during pregnancy,
after blood transfusions, from previous organ
transplantations, or, in rare cases, infections. The presence
of donor specific antibodies is either an absolute or relative
contraindication, depending on the breadth and strength of
the antibody response. For this group of patients with a wide
range of anti-HLA antibodies, it is extremely difficult to find a
compatible donor.
In 2020, the European Commission granted a conditional
approval in the European Union for Idefirix
®
(imlifidase),
representing the first conditionally approved treatment for
adult patients waiting for a kidney transplant who are highly
sensitized against tissue from the donor and who have a
positive crossmatch test against an available kidney from
deceased donor. The basis for this conditional approval was
based on two completed phase 1 studies in healthy subjects
and four completed phase 2 studies in highly sensitized
kidney patients. In total, 53 healthy subjects have been
exposed to imlifidase and 46 patients were transplanted
after imlifidase treatment. Post-hoc analyses of the data,
pooled from all studies, showed that 43 out of a total of 46
patients had a functioning kidney six months after
transplantation. A post approval efficacy study (PAES) in 50
highly sensitized patients in Europe was initiated in 2022 and
will run in parallel with the commercial launch until 2025 at
the latest. The PAES will support integrating the commercial
and scientific approach and help broadening the clinical
experience with imlifidase.
~50,000
Transplants performed across U.S.
and Europe in 2021
1
73% of kidneys from deceased donors
10-15%
Highly sensitized patients
awaiting kidney transplant
1
~170,000
Total number of patients
waitlisted in 2021
1
across U.S./EU
1
Source: The U.S. Department of Health and Human Services and .irodat.org
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2021
2020
2019
2018
5,234
18,410
6,867
17,406
6,442
15,561
5,811
14,827
5,971
19,519
2017
8%
3%
*
10%
7%
4%
23,644
24,273
22,003
20,638
25,490
Up to 15% of the patients waiting for a new
kidney are highly sensitized
~50,000 transplants are done annually across
the U.S. and Europe
Breakdown of the kidney transplant waitlist in U.S. and EU
1
U.S. annual kidney transplants
Total
5Y avg 23,210
5Y avg 25,900
Total
YoY
YoY
Europe annual kidney transplants
1
Source: The U.S. Department of Health and Human Services and .irodat.org
~170,000 kidney patients
waiting for a transplant
~50,000 sensitized patients
(cPRA above 20%)
~25,000 highly sensitized patients
(cPRA above 80%)
~12,000 with
cPRA
(above 98%)
~5,000 with
cPRA
(above 99,9%)
13%
22%
*
1%
3%
2%
5,824
15,999
7,766
20,287
7,820
20,097
7,565
19,510
2020
7,400
17,300
2021
2019
2018
2017
21,826
24,700
28,053
27,917
27,075
Deceased Donor Transplants
Living Donor Transplants
* Reported to be impacted by the COVID-19 pandemic
Source: Global Observatory on Donation and Transplantation, http://www.transplant-observatory.org/
Helping highly sensitized patients who cannot access a kidney
continued
The kidney transplantation landscape in Europe and the U.S.
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Highly focused and sequenced
launch strategy
Our European launch strategy
Idefirix
®
is the first and only treatment approved in Europe for
desensitization treatment of highly sensitized patients. The
introduction of this potential transformative drug is viewed by
many leading experts, clinicians and payers as enabling a
paradigm shift towards equity of access for highly sensitized
patients to potentially lifesaving and life altering kidney
transplants. To reach this goal we work closely with the
transplant community to reshape the area of desensitization
and integrate Idefirix
®
into clinical practice as a new standard
of care.
As part of our launch strategy, we are initially focused on
targeting leading centers with the potential to become
centers of excellence. At Hansa, we believe that the long-
term market uptake of this innovative therapy is highly
dependent on successful early experiences in key early
adopter centers. It is critical for a successful launch of
Idefirix
®
, that positive outcomes are generated in the first
patients and for clinical centers to build the foundation
necessary for expanded use of Idefirix
®
as a potential new
“Gold Standard” in desensitization protocols.
Our anticipated “S”-shaped launch curve reflects this careful
approach in the initial years of commercialization until more
accelerated growth occurs, which is anticipated mid-term, as
the Company expands beyond the first wave of early-launch
countries and leading clinics, leverages the full potential in the
five largest European markets and prepare for a U.S. launch,
following FDA approval. Longer term, Hansa may consider
expanding the label to include other solid organs such as heart
and lung and living donor transplantation.
During 2022, Hansa secured positive pricing and
reimbursement decisions in four of the five largest markets
- the U.K., Germany, Italy and France, through a reimbursed
early access program. In total, market access has now been
secured in eleven countries, while market access procedures
are ongoing in nine countries including Spain,
1
which
represents the last of the five major European markets.
1
A positive recommendation for pricing and reimbursement of Idefirix
®
in Spain was
published on February 6, 2023 https://www.sanidad.gob.es/profesionales/
farmacia/pdf/20230202_ACUERDOS_CIPM_230.pdf
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Initial years of commercialization
Illustrative
Mid term
Longer term
1.
Build the foundation for Idefirix
®
in EU to
become a new Standard of Care
>
Commercialize in early-launch countries focusing on
leading clinics and early adopters
>
Secure Pricing and Reimbursement agreements
>
Ensure clinical readiness and KOL engagement
>
Implement new medical guidelines through ESOT
>
Increase awareness on unmet need through KOL
engagement, patient organizations and medical
conferences
>
Initiate post approval study in Europe to support full
approval and establish long-term outcomes
Commercial sales uptake
2.
Expanding internationally will lead to more
accelerated growth mid term
>
Leverage experience to scale Idefirix
®
in Europe with
early-launch centers and in the five largest markets
after completing market access
>
Launch in the U.S. following completion of the
ConfIdeS study and FDA approval
>
Expand to select markets and regions beyond core
markets in EU and the U.S. through partnerships
>
Full marketing authorization in Europe
>
Support patient and organ access for highly
sensitized patients
3.
Potential label expansion may enable
new growth pockets longer term
>
Commercialize in AMR in kidney upon potential approval
>
Potentially expand into living donor transplantation
>
Potentially expand into other solid organ
transplantations such as heart and
lung pre- and post transplantation (AMR)
“Low initial uptake and growth”
Sales initially remain “low and volatile” between
quarters during the initial launch years until early
positive experiences are generated for Idefirix
®
to
become a new SoC
“More accelerated growth”
Expand broader and internationally
“Growth from pursuing
new opportunities”
Potentially enable label expansions
Scaling Idefirix
®
globally as we transform the
desensitization treatment landscape and
advance a new way of transplanting patients
Idefirix
®
is the first and only approved drug in Europe for desensitization treatment of
highly sensitized kidney transplant patients. The long-term market uptake is highly
dependent on successful early experiences in key early adopter centers
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Market access has now been secured in
eleven European countries and procedures
are ongoing in nine countries including
Spain
2
, which represents the last of the
five major European markets
Unit
ed Kingdom
2,917
Transplants
1
Germany
1,992
Transplants
1
France
3,252
Transplants
1
Spain
2,950
Transplants
1
Italy
2,043
Transplants
1
1
Annual kidney transplantations 2019 (pre COVID-19)
Transplantation data is from Global Observatory on Donation
and Transplantation, 2019
2
A positive recommendation for pricing and reimbursement of Idefirix
®
in
Spain was published on February 6, 2023 https://www.sanidad.gob.es/
profesionales/farmacia/pdf/20230202_ACUERDOS_CIPM_230.pdf
Health Technology Assessments (HTA) dossiers filed
Reimbursed Early Access Program
Pricing & reimbursement obtained (country or clinic level)
Territories covered commercially by Medison Pharma
Ongoing market access processes
Positive reimbursement decisions
received in four of the five largest
markets - Italy, U.K., Germany and
France (early access)
Israel
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Providing a new opportunity to a growing number of
highly sensitized patients on kidney transplants lists
Q
.
In 2022 Hansa secured pricing and reimbursement
for Idefirix
®
in several key European countries – how
did you do it?
A
. Pierre-Henri:
We made significant progress
commercialising Idefirix
®
in Europe last year. We have a
dedicated team of highly skilled colleagues who
understand both the healthcare system in each country as
well as the transplantation community. With strong
capabilities and data that demonstrates the value of our
product, we were able to expand our footprint in key
markets in Europe. Inclusive of all national authorizations,
early access decisions, and authorizations on a hospital
basis, by the end of 2022 we secured pricing and
reimbursement in eleven European countries including four
of the five largest markets. Additionally, we secured
reimbursement in Israel in March 2022 making commercial
progress outside of Europe. Currently, we have access and
marketing authorization procedures ongoing in nine
countries, including Spain, where in early February 2023
Idefirix
®
received a positive recommendation by the
Inter-Ministerial Pricing Commission for Pharmaceuticals
1
.
Q
.
Why is achieving access in the five largest markets in
Europe important to the success of Idefirix
®
?
A
.
Pierre-Henri:
Achieving reimbursement in the five most
populated countries in Europe is an important objective
and a priority in our European launch strategy, as it secures
access to Idefirix
®
for a significant portion of European
highly sensitized patients. Germany, UK, France, Italy, and
Spain together account for the largest waiting lists and two
thirds of all transplantations from deceased donors
performed in Europe.
2
These countries also have several
specialised centres with the capability to include Idefirix
®
-
induced transplantation into clinical practice
.
Q
.
Beyond these five markets, how are you
progressing commercialisation efforts in Central
and Eastern Europe?
A
.
Pierre-Henri:
We recognize there is high unmet need for
transplantation patients in many markets including Central/
Eastern Europe. For some of these markets we have
identified commercial partners that can help accelerate the
pricing and reimbursement process. We have achieved
reimbursement in Poland in partnership with Medison
Pharma, and in Czech Republic in partnership with
ExceedOrphan. We are very satisfied with the progress,
and the results so far prove that we have selected the right
partners, establishing valuable collaborations that can
effectively help us increase our reach.
Pierre-Henri Patin, VP Commercial Europe, and Gina Ewy, VP Global Market Access
1
Acuerdos de la Comision Interministerial de Precios de los Medicamentos. Sesión 230 de 15 de diciembre de 2022.
Available at: https://www.sanidad.gob.es/profesionales/farmacia/pdf/20230202_ACUERDOS_CIPM_230.pdf
2
Global Observatory on Donation and Transplantation. Available at: https://www.transplant-observatory.org/export-
database/ Last accessed January 2023
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Interview
Q
.
Gina, as the VP of Global Market Access you and your
team are involved in every step of the pricing and
reimbursement negotiations. What are you hearing
from regulators and health decision makers?
A.
Gina:
We believe the progress we’ve made in several
countries in Europe is largely due to our ability to
demonstrate the high unmet need of highly sensitized
transplant patients and the clear value that Idefirix
®
can
bring to this patient population. Regulators and decisions
makers recognise the important role Idefirix
®
can play in
enabling patients to receive a life altering kidney
transplant and eliminate the need for timely and costly
dialysis treatments. I think the recommendation by NICE
in the UK is a great example where the unmet needs of
highly sensitized kidney transplant patients drove the
conversation resulting in reimbursement and access of
Idefirix
®
for patients and clinicians
Q
.
You mentioned the value of Idefirix
®
in providing the
opportunity for lifesaving kidney transplantation.
Can you elaborate on this?
A
.
Gina:
Transplantation is the preferred treatment for all
chronic kidney disease patients. This includes many
highly sensitized patients, who currently have very few
chances to receive an organ offer due to the presence of
donor specific antibodies. By rapidly inactivating
Immunoglobulin G, Idefirix
®
enables an otherwise
incompatible kidney transplant to occur. Clinical evidence
confirms that successful kidney transplants are
associated with a better survival and quality of life
outcomes compared to remaining on dialysis
3,4
. Idefirix
®
works alongside allocation systems to increase equity in
access to transplant for highly sensitized patients, who
otherwise have little to no hope for a transplant due to
sensitization status.
Q
. Considering the countries Pierre-Henri mentioned,
how many highly sensitized patients could potentially
be eligible for Idefirix
®
?
A
.
Gina:
In Europe, the classification of highly sensitized
patients and eligibility vary from country to country and is
dependent on the allocation system. Highly sensitized
patients account for approximately 10% to 15% of
patients waiting for kidney transplants.
5
This number is
even higher in some countries including Spain where one
patient in five, so 20% is classified as highly sensitized
against potential donor tissues.
6
These are patients in
urgent need of innovative treatments as they have so far
been unable to find a suitable donor and have been left
on transplant waiting lists. With these authorizations in
place, a growing number of highly sensitized patients can
be considered for transplantation from a deceased donor
with the use of Idefirix
®
.
3
Pankhurst L, Hudson A et al. 2017,
4
Heidt and Claas 2018
5
EDQM. (2020). International figures on donation and Transplantation 2019 and
SRTR Database and individual assessments of allocation systems
6
PATHI – Plan nacional de acceso a trasplante de pacientes hiperinmunizados.
Available at https://sgan.es/ponencias-6-o-congreso-de-la-sociedad-gallega-
de-nefrologia/. Last accessed: January 2023
Providing a new opportunity to a growing number of highly sensitized
patients on kidney transplants lists
continued
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Interview
Dr Lucrezia Furian, Associate Professor of Surgery, Department of Surgical Oncological and Gastroenterological Sciences,
University of Padova, Italy, shares her experience in performing the first imlifidase-enabled kidney transplantation in Italy.
1
Q
.Dr Furian, you and your team at the University Hospital
of Padova recently performed a successful kidney
transplantation following desensitization with
imlifidase in a highly sensitized patient. Can you tell
us more about this?
A
.
On November 1st, 2022, following desensitization with
imlifidase we were able to successfully perform a kidney
transplantation in a very highly sensitized patient who had
been on dialysis for almost 14 years and had previously
rejected another donor kidney. The patient is doing well and
at home with their family. This is a great example of how
new innovative treatments can help patients who may
previously had little to no other treatment options.
Q
.How important was it to appropriately and
effectively desensitize the patient before
attempting transplantation?
A
.
Achieving an effective desensitization through a rapid
inactivation of IgG, and specifically of pre-formed donor-
specific antibodies, was crucial to enable transplantation.
The patient had been listed in the national kidney allocation
system for many years, and still it took 14 years to be able to
perform a transplant due to their significantly high level of
sensitization. We were able to successfully perform the
transplant because of the almost complete inactivation of
pathogenic antibodies using imlifidase. Without imlifidase
we would not have been in the position to offer this patient a
kidney transplant.
Q
.Why was this patient so immunologically complex and
why was it decided to treat this candidate?
A
.
For some kidney patients, identified as highly sensitized,
finding a compatible donor is particularly challenging.
These patients present antibodies against potential donors,
usually developed following a previous transplant, blood
transfusion or pregnancies. Therefore, those patients are
often waiting a long time for a suitable organ. The patient we
decided to treat with imlifidase presented all these
complexities. We knew it was going to be challenging, but
we also knew that this patient had high unmet need and
was left with no other treatment option.
Q
.You are also one of the authors of the European Society
for Organ Transplantation’s (ESOT) guidelines for
desensitization. How important is it to have a
comprehensive desensitization strategy in place that
physicians can use to predict and address potential
problems in the treatment of highly sensitized patients?
A
.
Imlifidase, although crucial, is not sufficient without a
thorough desensitization and post-transplant strategy.
After years of research, we believe we have refined this
approach for the best patient outcomes. Together with
other leaders in the field, we have worked with ESOT to
develop the first international consensus protocol,
published in 2022. It took us four years of research to be
able to define a deimmunization protocol suited for
treating highly sensitized patients such as this one. Now
we have a potent tool at our disposal, and a protocol
defined by experts to maximise our chances of success.
Q
.The picture you’re depicting is that of an advancement
in renal transplantation, do you see this as a pathway
to new opportunities for highly sensitized patients?
A
.
Highly sensitized kidney transplant patients have so far lived
with limited to no hope of receiving a kidney transplant. With
the introduction of new treatment options and approaches,
Building experience with imlifidase-enabled
kidney transplantations
we can address the unmet need in of these patients. It is
also critically important to ensure we identify appropriate
candidates who can benefit the most from this
desensitization treatment, and that clinicians are familiar
with the desensitization guidelines to ensure that
appropriate protocols are put in place to manage these
patients during and after transplantation.
In medicine, there are no silver bullets. There is hard work,
innovation, and forward progress that create new options
for better patient outcomes particularly in those cases
where there remains high unmet need. I think the success
we had with the highly sensitized patient at the University
Hospital of Padova is a good example of where innovation
has given hope.
.
1
As of December 2022, imlifidase is available in Italy under the name Idefirix
®
for the desensitization of highly sensitized
adult patients prior to kidney transplant from a deceased donor
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25
The role of immunoglobulin antibodies
26
Imlifidase – a novel approach to eliminating pathogenic IgG
27
Progress of IgG-modulating technologies
28
Our unique antibody cleaving enzyme technology may have
relevance across a range of indications
30
Intellectual property rights and orphan drug designations
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4
Technology
An immune response begins with the recognition of a pathogen
or foreign molecule, followed by a reaction to eliminate it
The role of immunoglobulin antibodies
IgM
IgG
IgA
IgE
IgD
0.002%
Antibody of allergy
and anti-parasitic
activity
1%
B Cell Receptor
13%
Secreted into mucus,
tears, saliva
80%
Main blood
antibody,
neutralizes toxins,
opsonization
6%
% of total
antibody
in serum
Function
Primary response,
fixes complement.
Monomer serves as
B-cell receptor
A wide variety of immune cells and molecules
are involved in the development of immune
responses. Antibodies, also known as
immunoglobulins (Ig), are proteins produced
and used by the immune system to recognize
and eliminate pathogens or other foreign
material. Each antibody binds to one of many
molecules on the microorganism’s surface,
hence, there may be several different
antibodies for a given pathogen.
Through this binding mechanism, one or more antibodies can
tag a pathogen or infected cell. This tagging then results in one
or several different so-called “effector functions”, in which
other parts of the immune system are activated in order to
inhibit and/or eliminate the pathogen or foreign material. The
human immune system uses different classes of antibodies
called isotypes, known as IgA, IgD, IgE, IgG, and IgM. The
isotypes have slightly different structures and they play
different roles in the immune system. Immunoglobulin G (IgG),
is the most common type found in the blood and tissue and
provides the majority of antibody-based immunity against
invading pathogens.
In various autoimmune diseases, the immune system
mistakenly mounts a response toward the body’s own cells
and tissues. This misguided attack results in various clinical
symptoms depending on which cells or tissues are subject to
the attack. In several autoimmune diseases, antibodies
capable of binding to self-antigens play an important role in
the attack. These are called autoantibodies.
In transplantation, by design, foreign material is introduced to
an individual’s immune system. In order to prevent the body’s
immune system from rejecting the transplanted organ, all
transplanted patients are treated with immunosuppressant
drugs. Donors and potential recipients also need to be
matched with respect to blood type and tissue type prior to
transplantation to minimize the risk of transplant rejection.
As part of a natural immune response against the transplanted
organ, the immune system can develop antibodies, which then
contribute to a rejection. This process is referred to as AMR
and these patients usually have developed antibodies to the
donors’ HLA (Human Leukocyte Antigen).
Patients in need of a new organ, such as kidney, lung or heart,
may also have developed anti-HLA (Human Leukocyte
Antigen) antibodies prior to the transplantation. Typically, these
pre-formed anti-HLA antibodies were developed earlier in life,
when patients were exposed to foreign HLA due to
pregnancies, blood transfusions or previous transplantations.
These individuals are referred to as HLA-sensitized or
HLA-immunized patients. In general, it is more difficult to find a
compatible donor organ for HLA–sensitized patients.
Patients on transplant waitlists are screened with respect
to their anti-HLA antibody profiles and are carefully tested with
respect to donor-specific antibodies (DSA) prior to an actual
transplantation. Highly sensitized patients have a wide
spectrum and often high levels of anti-HLA antibodies and are,
therefore, likely to have DSAs. Since DSAs are likely to target
and significantly compromise a transplanted organ, these
patients are often prevented from receiving a transplant.
The broader reactivity of the antibodies, the lower the
likelihood of finding a donor organ that will be a match. As a
result, many of these highly sensitized patients remain, for an
indefinite period, in a debilitating disease state on long-term
dialysis treatment, which is associated with high cost, a poor
quality of life and an increased mortality rate.
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Imlifidase – a novel approach to eliminating pathogenic IgG
Imlifidase’s
Mode of Action
is that it very
rapidly and effectively cleaves
Immunoglobulin G (IgG) within 2-6 hours from
a 15-minute infusion. The IgG is cleaved
below the so-called ‘hinge region’, creating
an F(ab’)2 and an Fc component.
After treatment, intact IgG levels will drop below detectable
levels and stay supressed for approximately 5-7 days, creating
a window for a kidney transplantation before it gradually returns
back to normal levels during the weeks following treatment. The
imlifidase enzyme is highly specific to IgG and all subclasses of
IgG and has been demonstrated to not affect other Ig-isotypes.
Imlifidase is an enzyme originating from a human pathogen, a bacterium called
Streptococcus pyogenes
which is a species of Gram-positive, spherical bacteria in
the genus
Streptococcus
and is usually known for causing a strep throat infection
>
Rapid onset of action that inactivates IgG below
detectable level in 2-6 hours from a 15-minute infusion
>
IgG antibody-free window for approximately one week
Imlifidase inactivates IgG in 2-6 hours from infusion
IgG (mg/ml)
0.5h
0
1h
2h
4h
6h
8h
1d
2d
3d
7d
14d
21d
28d
64d
10
8
6
4
2
0
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Progress of IgG-modulating technologies
PLEX, plasmapheresis,
immunoadsorption
Mechanically removes antibodies
from circulation
B-cell depleting mAbs
Lowering antibody levels
through B-cell elimination
Proteasome inhibitors
Depletes antibody producing
long-lived plasma cells and lowers
overall immunoglobulin levels
IV/SC immunoglobulins
IVIg/SCIg contains healthy
antibodies that replaces
pathogenic antibodies
Complement inhibitors
Prevents binding of
complement protein to
antibodies
FcRn-inhibitors
Lowering IgG through
blocking of antibody
recycling
1950s
1980s
1990s
2000s
2010s
2020s
Mechanisms can be both complementary and competing
Imlifidase – IgG-cleaving enzyme
Deactivates IgG within 2-6
hours through enzymatic
cleavage. IgG-free window
for approximately one week
Unique mechanism-of-action
is the basis for competitive
advantage vs other IgG-
modulating therapies
FC
F(ab’)
2
Imlifidase
Complement
binding to IgG
Complement
inhibition
Inflammation
Cell lysis
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Our proprietary antibody-cleaving enzyme
technology platform targeting pathogenic
antibodies is at the core of our business. To
sharpen our focus and commitment toward
advancing Hansa’s platform beyond kidney
transplantation, we have established four
distinct franchises in transplantation,
autoimmune diseases, gene therapy and
oncology/new therapies.
Imlifidase is designed to inactivate IgG antibodies in both
plasma and tissue, with a single intravenous treatment in
monophasic autoimmune diseases, transplantation, and gene
therapy. We are also developing a second generation of
IgG-cleaving enzymes under the umbrella “NiceR”. The new
enzymes are designed to have lower immunogenicity, thereby
potentially enabling multiple administration for inactivation of
flares in relapsing diseases. Specifically, we completed IND
enabling toxicology studies at the end of 2022 for the lead
NiceR candidate HNSA-5487. A CTA approval has since been
obtained and we expect to start a clinical trial in the first half
2023. These new enzymes could potentially open a new
treatment paradigm in a broad range of indications.
In addition to identifying the most relevant indications for our
enzymes, we are also exploring how our unique antibody-
cleaving enzyme technology potentially can be used in
combination with other technologies targeting IgG antibodies.
For example, FcRn inhibitors, which do not give the same rapid
and effective response as imlifidase but can be useful for
long-term management in indications known to be driven by
disease-causing IgGs.
Our unique antibody cleaving enzyme
technology may have relevance across
a range of indications
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GBS
Anti-
GBM
Kidney
Trans-
plantation
EU
AMR
Kidney
Trans-
plantation
U.S.
Duchenne
Limb-
Girdle
Pompe
EnzE
HCST
(Bone
Marrow)
OUR VISION
TODAY
i
m
l
i
f
i
d
a
s
e
+
c
o
m
b
i
n
a
t
i
o
n
i
m
l
i
f
i
d
a
s
e
N
i
c
e
R
Targeting rare IgG mediated diseases
Expanding our
commercial franchises
Regulatory approval (conditional)
Clinical development
Planned clinical trial
Partnership (preclinical development)
Preclinical development
Potential indications (currently not pursued)
Transplantation
Shaping a new standard for
desensitization will help
enable new indications in
transplantations
>
Antibody mediated rejection
(AMR) in kidney transplantation
>
Other transplantation types
Autoimmune diseases
Anti-GBM paves the way for
development in other
autoimmune diseases
>
Rapidly progressive
glomerulonephritis
>
Neurological disorders
>
Skin and blood disorders
New therapies
and oncology
IgG-cleaving enzymes to
enable or even potentiate
cancer therapy
>
Allogenic stem cell (bone
marrow) transplantation
(HSCT)
>
Enzyme-based antibody
Enhancement (EnzE)
Gene therapy
Exploring opportunities in
gene therapy
>
Encouraging preclinical
data published in Nature
>
Validation through
collaborations with Sarepta
and AskBio
>
Wide indication landscape
beyond
Our unique antibody cleaving enzyme technology may
have relevance across a range of indications
continued
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Intellectual property rights and
orphan drug designations
Hansa aims at securing broad patent and
related IP protection for our current and
future products and treatments developed
within our technology platform.
The Company’s patent and related IP position is global, and
covers markets deemed to be of critical clinical, manufacturing
and commercial relevance for the product pipeline. As our
technology platform further develops, we will pursue new
patent and related IP filings.
Our IP portfolio currently includes patent families related to
imlifidase and its use, with coverage up to 2035, in key
markets. Geographically, these patent families cover a large
number of jurisdictions, including the U.S., Europe and Japan.
Our lead product, imlifidase, is protected by six patent families
including both granted patents and pending applications and
cover the use of isolated imlifidase. The most significant patent
families protecting imlifidase and its use provides basis for
extended patent term extensions (PTEs), which are available in
certain major markets, including the U.S. and the EU (as
supplementary protection certificate, SPC). The term of the
PTE/SPC can vary from zero to maximum five years,
depending on the time taken to obtain marketing approval.
Patents with expirations up to 2035 can be extended up to five
years via available patent term extensions.
In addition to patent and IP related protection, the Company
continuously evaluates the opportunities for market exclusivity
for drug candidates through orphan drug designations and
data exclusivity.
Orphan drug designation is granted to therapies aimed at
treating life-threatening or chronically debilitating rare diseases
where no therapeutic options are either authorized, or where
the drugs will be of significant benefit to those affected by the
condition. Rare diseases are those defined as having a
prevalence of no more than five in 10,000 persons in Europe or
affecting less than 200,000 patients in the U.S. The designation
provides development and commercial incentives, including
ten years of market exclusivity in the EU and seven years in the
U.S., protocol assistance on the development of the drug,
including clinical studies and certain exemptions from or
reductions in regulatory fees.
Since 2017, Hansa has been granted five orphans drug
designations by EMA/EC and the FDA across transplantation,
anti-GBM antibody disease and GBS (only FDA).
EMA/AC orphan drug designation
>
Imlifidase for the prevention of graft rejection
following solid organ transplantation (2017)
>
Imlifidase for the treatment of the rare and acute
disease anti-GBM (2018)
Since 2017, Hansa has been granted
five orphans drug designations by
EMA/EC and the FDA across
transplantation, anti-GBM antibody
disease and GBS (only FDA)
FDA orphan drug designation
>
imlifidase for the prevention of antibody-mediated
organ rejection in solid organ transplantation (2015)
>
imlifidase for the treatment of Guillain-Barre
Syndrome (2018)
>
imlifidase for the treatment of the rare and acute
disease anti-GBM (2018)
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32
Our development programs
33
Continuous progress in our ongoing clinical programs
34
U.S. randomized control trial “ConfIdeS”
36
Interview: Hansa’s Post Authorization Efficacy Study (PAES)
in highly sensitized kidney transplant patients
37
Opportunities beyond kidney transplantation
38
Hansa’s antibody cleaving enzyme technology
40
Active antibody mediated rejection (AMR)
41
Guillain-Barré Syndrome (GBS)
42
Exploration of Hematopoietic Stem
Cell Transplantation (HSCT)
5
Our development programs
Broad clinical pipeline in transplantation and autoimmune diseases
Research/
preclinical
Phase 1
Potentially pivotal/
Phase 2
Phase 3
Marketing
authorization
Marketed
Next anticipated
milestone
Imlifidase
EU: Kidney transplantation in highly
sensitized patients
1.2
EU: Additional agreements around
reimbursement / Post approval study
to be completed by 2025
U.S.: Kidney transplantation in highly
sensitized patients
1.2
Completion of enrollment (64 patients)
H1 2023
Anti-GBM antibody disease
3
First patient enrolled (50 patients)
Antibody mediated kidney transplant
rejection (AMR)
Full data read-out H2 2023
Gullain-Barre Syndrome (GBS)
Completion of enrollment
(30 patients) H1 2023
Pre-treatment ahead of gene therapy in
Duchenne (Partnered with Sarepta)
Preclinical research
Pre-treatment ahead of gene therapy in
Limb-Girdle (Partnered with Sarepta)
Initiate clinical study of imlifidase as
pre-treatment in DMD 2023
Pre-treatment ahead of gene therapy in
Pompe disease (Partnered with AskBio)
Preclinical research
NiceR
Recurring treatment in autoimmune diseases,
transplantation and oncology
Initiate Phase I study of HNSA-5487
(Lead NiceR candidate) H1 2023
EnzE
Cancer immunotherapy
Research
1
Results from the Phase 1 study have been published, Winstedt el al. (2015) PLOS ONE 10(7)
2
Lorant et al American Journal of Transplantation and 03+04 studies (Jordan et al New England Journal of Medicine)
3
Investigator-initiated study by Mårten Segelmark, Professor at the universities in Linköping and Lund
Completed
Ongoing
Planned
Post approval study running in
parallel with commercial launch
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>
30/30 patients enrolled in the AMR
phase 2 study
>
Data read out demonstrates a statistically
significantly superior capacity of
imlifidase to rapidly reduce levels of
DSAs compared to plasma exchange
(SoC) in the five days following the start
of the treatment
>
Full data read out expected H2 2023,
which will determine the path forward for
imlifidase in patients with active AMR
Antibody Mediated Rejection
phase 2
>
New pivotal Phase 3 study initiated in first
sites in the U.S and U.K. end of 2022
>
Open label, randomised controled study
targeting 50 patients to be treated with
imlifidase and SoC or SoC alone
>
Kidney function (eGFR) will be evaluated
as the primary endpoint
>
The first patient is expected to be enrolled
in H1 2023
Anti-GBM
phase 3
>
25/30 patients enrolled in the GBS
phase 2 study
>
10 centers are active and open for
recruitment
>
Aim to complete enrolment of GBS
patients H1 2023
>
Aim to communicate first high-level data
read out in H2 2023
Guillain-Barré Syndrome
phase 2
>
51/64 patients enrolled for randomization
>
13 centers active and open for
recruitment; continously adding new
clinics, with a goal of at least 20, to
further increase entollment capacity
>
Expect to complete enrollment H1 2023
and complete randomization in H2 2023
>
BLA submission is expected in 2024
under the accelerated approval path
U.S. ConfIdeS trial in kidney
transplantation phase 3
Enrollment status February 1, 2023
Completed
5
25
13
51
Patients enrolled
Patients remaining
Initiated
Continuous progress in our
ongoing clinical programs
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U.S. randomized control trial “ConfIdeS”
The ConfIdeS trial is evaluating imlifidase
as a potential desensitization therapy to
enable kidney transplants in highly
sensitized patients waiting for a
deceased donor kidney through the
U.S. kidney allocation system.
The trial is expected to randomize 64 highly sensitized
kidney transplant patients with a cPRA of ≥99.9%,
representing a subset of very highly sensitized patients that
continue to be disadvantaged despite prioritization under
the U.S. kidney allocation system. When a donor organ
becomes available and a positive crossmatch with the
intended recipient indicates that the organ is not
compatible, the patient will be randomized to either
imlifidase desensitization treatment or to a control arm
that will receive standard of care (i.e. waiting for a more
compatible kidney offer or receiving an experimental
desensitization treatment). The study’s primary endpoint
for imlifidase to evaluate benefit in transplanting highly
sensitized patients is kidney graft function at 12 months,
measured by eGFR (estimated Glomerular Filtration Rate).
Robert A. Montgomery, M.D., Professor of Surgery and
Director, NYU Langone Transplant Institute in New York
City, has been appointed National Coordinating Investigator
for the ConfIdeS trial. The trial will enroll patients at up to
20 leading transplantation centers in the U.S (13 leading
centers were active on December 31, 2022).
Completion of enrollment in the study is expected in the
first half of 2023, while randomization is aimed for
completion by the second half of 2023. Following a
12-month follow-up period, results are expected to support
a BLA under the accelerated approval pathway in 2024, as
previously guided.
In addition to the ongoing ConfIdeS trial in kidney
transplantation, Hansa is also carrying out a post approval
efficacy study (PAES) in parallel with the commercial launch
in Europe. The PAES was initiated in July 2022 and is an
obligation under the European conditional marketing
authorization and will be used to further investigate the
long-term graft survival in 50 highly sensitized kidney
transplant patients treated with Idefirix
®
. The PAES is
expected to be completed by end of 2025, at the latest.
In addition to this, a long-term follow-up study is also done
in patients who have undergone kidney transplantation after
imlifidase administration as part of the four phase two
studies. In 2021 the three-year follow-up data was published
demonstrating graft survival of 84% after imlifidase
treatment and transplantation and a mean eGFR of 55 mL/
min/1.73 m2, which is in line with expectations in imlifidase
treated transplant patients compared to outcomes in
patients undergoing HLA-incompatible transplantation.
The next read-out on the long-term follow-up trial is
expected in the second half 2023, when the five-year data
is expected to be published.
Lastly, Hansa is conducting a rebound study in patients
treated with imlifidase prior to kidney transplantation. The
study aims at including twelve patients to assess whether
imlifidase, in combination with bortezomib, belatacept,
rituximab and IVIg, can suppress DSA and the occurrence
of AMR in highly sensitized crossmatch positive patients
undergoing living or deceased donor transplantation.
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159
1,204
0
43
2,619
726
268
372
0
57
41
166
179
86
218
172
615
218
506
397
580
910
316
1,041
168
577
124
371
296
674
285
764
736
86
1,684
1,579
5
243
540
20
26
41
3
463
296
0
41
371
Cedars Sinai
Keck Hospital of USC
Houston Methodist Hospital
Saint Barnabas Medical Center
Washington University
School of Medicine
UAB Hospital
Methodist Specialty &
Transplant Hospital
MedStar Georgetown
Hospital of the University
of Pennsylvania
John Hopkins
Columbia University
Hospital
NYU Langone
Northwestern Memorial Hospital
41
1
2019 data from Organ Procurement & Transplantation Network
2
United Network for Organ Sharing
3
EDQM. (2020). International figures on donation and
Transplantation 2019 and SRTR Database and individual
assessments of allocation systems
U.S. randomized control trial “ConfIdeS”
continued
Our ConfIdeS study is currently enrolling patients
across thirteen leading transplantation centers
across seven states covering 10-15% of annual
kidney transplants in the U.S.; Aim to have up to
20 centers recruiting patients
71%
1
Deceased donor
~10-15%
3
Waitlisted patients are highly sensitized
~90,000
2
Waiting for a kidney transplant
13 leading
transplantation
centres
With experience in desensitization and highly
sensitized patients are currently active
>2,500
1
Combined annual kidney transplants
>300
1
Highly sensitized (>80% cPRA)
23,000
1
Annual kidney transplantations
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Q
.Why is Hansa conducting a post-authorization efficacy
and safety trial?
A
.
Jan:
In 2020, Hansa received a conditional authorization
by the European Commission for Idefirix
®
. With that
authorization came the obligation to run a post-
authorization efficacy study, a confirmatory trial. The
PAES we are now running is a truly international European
study, involving patients and transplant centers across
many different European countries. Its completion will
allow us to collect the necessary evidence to turn the
conditional authorization in the European Union into a full
marketing authorization by the end 2025 at the latest.
Q
.Can you describe the trial design? What’s its
advancement status?
A
.
Lina:
The study is set to include a total of 50 patients
across 20 centers in Europe. The patients will receive
imlifidase and subsequently undergo a kidney
transplantation. As of February 2023, thirteen sites are
open for recruitment with several imlifidase-ready patients
having been identified. End of 2022 seven patients have
been transplanted following desensitization with imlifidase.
Q
.What challenges does this trial pose?
A.
Jan:
Imlifidase represents a paradigm shift in the
management of highly sensitized kidney patients. With
imlifidase, we enable incompatible kidney transplantation
by turning a positive crossmatch to negative. That is done
by inactivating the donor-specific antibodies with a broad
reactivity against human leukocyte antigens, which can
cause an immune response against non-self tissues such
as a donor’s organ. Historically, incompatible
transplantation has not been considered a viable option
and as a result, we must ensure desensitization is smoothly
integrated into the treatment process. This demands that a
high degree of coordination is ensured at transplant centers
early on in the initiation process with multi-disciplinary
teams being established.
Furthermore, since this is a cross-European trial, we work
with different regions and allocation systems and criteris for
sensitization. Importantly, we strive to accommodate
imlifidase at a country-by-country basis to complement the
allocation systems and local practices.
Another challenge comes with the complex immunological
status of the patients identified. With imlifidase we want to
provide an opportunity to those highly sensitized kidney
patients that so far have had very few or no chances to
receive a transplant due to their immunological status. Even
in the face of these complexities, we are seeing very
positive results, and this is thanks to the preparedness of
the treating physicians and the medical support we provide
to them.
Q
.From your description it seems that the collaboration
and communication with the transplant centres are
key to ensure the functioning of this trial. Can you
elaborate on that?
A
.
Lina:
Not only communication and collaboration, but also
proper preparation and support. We have established a
very good interaction with healthcare professionals from a
safety and initiation perspective, aimed at ensuring that they
are prepared when their transplant center starts enrolling
and possess the knowledge needed to start using imlifidase
in the an effective and controlled manner, in accordance
with the clinical trial protocol. This starts with the
collaboration with HLA laboratories, which assist in
identifying the best possible donor organ for a certain
patient, continues with the desensitization procedure, and
extends into the follow up during the post-operative phase.
Q
.Do you feel this approach is working? What is the
response you are seeing by healthcare professionals?
A
.
Lina:
Yes, we can definitively say that this approach has so
far been successful, and a good part of its success is
thanks to the unique commitment we see from physicians
themselves. Most of the professionals we are in contact
with through the trial have known imlifidase for long time
and are eager to use it, because ultimately, they are driven
by the desire to treat these highly sensitized patients who
have been left waiting for long time. They are aware of the
complexities that come with treating these patients, but this
doesn’t discourage them. On the contrary, they find being
able to assist these patients and accompany them through
the process very rewarding. They want to study, learn, and
perfect the procedure, they are truly involved and
committed, and we can see this in every meeting and
scientific exchange we have with them.
Jan:
Putting all these aspects together, we are confident
that this PAES trial will be beneficial for Hansa, the
transplant community, and, most importantly, for patients,
because we believe it will help build the knowledge
on imlifidase-enabled transplantations in Europe and further
strengthen the confidence on the role imlifidase can play in
enabling kidney transplant for those highly sensitized
patients with the highest unmet medical need.
Jan Tollermar, Senior Medical Director, Lina Nilsson Senior Clinical Resource Manager
Hansa’s Post Authorization Efficacy Study (PAES)
in highly sensitized kidney transplant patients
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Interview
Opportunities beyond kidney transplantation
Hansa’s unique antibody-cleaving platform
may have relevance in numerous autoimmune
diseases, where IgG autoantibodies play
an important role
What is an Autoimmune disease?
>
Humoral or cell-mediated immune responses to self-antigens
(breaking of tolerance)
>
Requires genetic predisposition, and often triggered by viral,
bacterial and/or other environmental factors
>
3-5%
1
of populations affected; mainly women (75%)
2
Over 100
different types of
Autoimmune
disorders
2
9
1
3
4
5
6
7
8
Brain
Multiple sclerosis, Neuromyelitis optica
Thyroid
Hashimoto’s disease, Graves’ disease
Bone and muscle
Rheumatoid arthritis, Dermatomyositis
Kidney
Anti-GBM disease
Skin
Psoriasis, Pemphigus
Lung
Wegner’s granulomatosis
Nerves
Guillain-Barré Syndrome, Myasthenia gravis
GI Tract
Crohn’s disease
Blood
Autoimmune hemolytic anemia, Immune thrombocytopenia
1
2
3
4
5
6
7
8
9
1
Wang et al., J. Intern. Med., 2015
2
Desai et al., Front. Endocrinol., 2019
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1
DeVrieze, B.W. and Hurley, J.A. Goodpasture Syndrome.
StatPearls Publishing, Jan 2021. https://www.ncbi.nlm.
nih.gov/books/NBK459291/ [accessed 2021-03-29]
2
Patel, M et al. The Prevalence and Incidence of
Biopsy-Proven Lupus Nephritis in the UK. Arthritis &
Rheumatism, 2006
3
Berti A, Cornec D, Crowson CS, Specks U, Matteson EL.
The Epidemiology of ANCA Associated Vasculitis in the
U.S.: A 20 Year Population Based Study. Arthritis
Rheumatol. 2017;69
4
Myasthenia Gravis. National Organization for Rare
Disorders, https://rarediseases.org/rare-diseases/
myasthenia-gravis/ [accessed 2021-03-29]
5
Guillain-Barré Syndrome. Orpha.net, https://www.orpha.
net/consor/cgi-bin/OC_Exp.php?Lng=GB&Expert=2103
[accessed 2021-03-29]
6
Chronic Inflammatory Demyelinating Polyneuropathy:
Considerations for Diagnosis, Management, and
Population Health. The American Journal of Managed
Care, https://www.ajmc.com/view/chronic-infammatory-
demyelinating-polyneuropathy-considerations-for-
diagnosis-management-and-population-health
[accessed 2021-03-29]
7
Marrie, R.A. The Incidence and Prevalence of
Neuromyelitis Optica. International Journal of MS Care,
2013 Fall: 113-118
8
Mehren, C.R. and Gniadecki, R. Epidermolysis bullosa
acquisita: current diagnosis and therapy. Dermatol
Reports, 2011-10-05
9
Wertenteil, S. et al. Prevalence Estimates for Pemphigus
in the United States. JAMA Dermatol, May 2019: 627-629
10
Immune Thrombocytopenia. National Organization for
Rare Disorders, https://rarediseases.org/rare-diseases/
immune-thrombocytopenia// [accessed 2021-03-29]
11
Warm Autoimmune Hemolytic Anemia. National
Organization for Rare Disorders, https://rarediseases.
org/rare-diseases/warm-autoimmune-hemolytic-
anemia/ [accessed 2021-03-29]
12
Litvinova, E. et al. Prevalence and Significance of
Non-conventional Antiphospholipid Antibodies in
Patients With Clinical APS Criteria. Frontiers in
Immunology, 2018-12-14.
Rapidly progressive
glomerulonephritis
Neurological
disorders
Skin
disorders
Blood
disorders
EBA
<1,000 patients*
8
Pemphigus
vulgaris
~40,000*
9
GBS
~10,000 patients*
5
Myasthenia
gravis
~210,000*
4
NMO
~20,000*
7
CIDP
~55,000*
6
Anti-
GBM
~1,000 patients*
1
Lupus
nephritis
~35,000*
2
ANCA-
associated
vasculitis
~325,000
*3
AHA
<1,000 patients*
8
ITP
~75,000*
10
HIT
0.1–5% of
patients receiving
therapeutic dose
of heparin14
elitis
WAHA
~95,000*
11
APS
~350,000*
12
Clinical programs
Potential indications (currently not pursued)
Total disease populations in EU & US, based
on prevalence and population data
CIDP:
Chronic inflammatory demyelinating
polyradiculoneuropathy
NMO:
Neuromyelitis optica
EBA:
Epidermolysis bullosa acquisita
ITP:
Immune thrombocytopenia
WAHA:
Warm antibody hemolytic anemia
APS:
Antiphospholipid syndrome
AHA:
Acquired hemophilia A
HIT:
Heparin‐induced thrombocytopenia
Hansa’s antibody cleaving enzyme technology
May have relevance in several autoimmune diseases where
IgG plays an important role in the pathogenesis
Hansa Biopharma Annual Report 2022
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Acute Anti-GBM antibody disease
(Goodpasture’s disease)
Anti-GBM, a rare acute autoimmune disease affecting kidneys and lungs
GN is a leading cause for kidney disease
GNN
Glomerulonephritis (GNN)
Diabetic neuropath
Adult polycytic kidney
disease
Hypertonicity
Pyelonephritis
Uremia
Others
Anti-GBM (anti-glomerular basement membrane disease),
also known as “Goodpasture´s disease”, is an acute and very
severe inflammatory disease impacting the kidneys. For
largely unknown reasons, the immune system develops
IgG-antibodies that recognize a membrane associated
antigen in the kidney and sometimes, in the lungs. Anti-GBM
is one form of glomerulonephritis (GNN), which comprises a
number of inflammatory diseases in the kidney and is a
leading cause of kidney disease. In glomerulonephritis, the
inflammation starts in the glomeruli (filtering unit of the
kidneys) and the small blood vessels. The result is an acute
immune attack on these organs. In most cases, anti-GBM
antibody disease leads to significant loss of kidney function,
requiring chronic dialysis or results in death.
Anti-GBM is an ultra-rare disease that affects approximately
1.6 per million people globally, every year
1,2
(e.g. 1,000 cases
across EU and the U.S. annually). For one out of six
patients, anti-GBM can become fatal during the acute
phase of the disease, while the majority of patients will end
up on chronic dialysis
3
. Only one in three anti-GBM patients
will have a preserved renal function after six months with
current treatment
4
.
In March 2022, Hansa announced that key data from an
investigator-initiated phase 2 trial (GoodIdeS) of imlifidase to
treat anti-GBM disease were published in Journal of
American Society of Nephrology (JASN)
5
. The study, led by
Principal Investigator, Mårten Segelmark, Professor of
Nephrology at Lund University, previously Linköping
University, showed that two-thirds of patients achieved
dialysis independence six months after treatment as
compared to typically two-thirds of patients losing their
kidney function and ending up on dialysis after six months.
The publication recognizes the study’s significance in
autoimmune diseases as it suggests that deactivation of
autoantibodies could alter the course of an autoimmune
disease, allowing restoration of kidney function. These
positive results mark an important milestone for the
expansion of imlifidase outside transplantation and into
autoimmune diseases.
Following the successful data in the phase 2 trial we have
commenced a pivotal phase 3 with the first sites initiated in
December of last year. The new global study is an open-
label, 1:1 randomized, controlled study targeting 50 patients
to be treated with either imlifidase and Standard-of-Care or
Standard-of-Care alone at up to 50 sites in the U.S. and
Europe. Today’s Standard-of-Care consists of a combination
of plasma exchange, cyclophosphamide and steroids. For
patients randomized to the imlifidase arm, the first round of
plasma exchange after randomization will be replaced by the
administration of imlifidase.
As a primary endpoint, kidney function will be evaluated by
eGFR at 6 months from randomization, while anti-GBM
antibody levels, pulmonary symptoms, safety,
pharmacokinetic/pharmacodynamic (PK/PD) and health
related quality of life measures, among others, will be
assessed as secondary endpoints.
More information about the trial is available at:
ClinicalTrials.gov under NCT05679401 (2022).
1
Kluth et al. J Am Soc Nephrol. 1999 Nov;10(11):2446-53
2
Hellmark et al. J Autoimmun. 2014 Feb-Mar;48-49:108-12
3
Cohort of 13 studies (661 patients in anti-GBM 1993-2017) Treating anti-GBM disease with imlifidase Mårten Segelmark, Professor OF Nephrology
4
Kluth et al. J Am Soc Nephrol. 1999 Nov;10(11):2446-53 and Hellmark et al. J Autoimmun. 2014 Feb-Mar;48-49:108-12
5
Uhlin F. et al. JASN. 2022; https://jasn.asnjournals.org/content/early/2022/03/08/ASN.2021111460
Inflamation in
the glomeruli
Early symptoms
are unspecific
Todays treatments
are inadequate
Early diagnostics and
treatments are crucial
But can lead to rapid
destruction of the
kidney and/or the lung
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Active antibody mediated rejection (AMR)
Long term graft survival is challenged by AMR episodes post transplantation
Active antibody mediated rejection, or AMR, is a serious
condition after transplantation that occurs in roughly 5-7
1
%
of kidney transplants and is a significant challenge to
long-term graft survival. AMR is the main cause for graft
dysfunction and loss after kidney transplantation. Today’s
standard of care for AMR treatment includes plasma
exchange and treatment with steroids and IVIg. AMR
patients not treated successfully risk graft failure, dialysis
and return to the waitlist.
2
Hansa has run a randomized, open-label, multi-center,
controlled phase 2 study in AMR. 30 patients with acute or
chronic acute AMR were enrolled across centers in France,
Germany, Austria, Australia and the U.S. The study is
designed to evaluate the safety and efficacy of imlifidase in
eliminating donor specific antibodies (DSAs) in acute AMR
patients, post transplantation. Twenty patients were
randomized to receive imlifidase treatment comprised of one
intravenous dose of 0.25mg/kg, while 10 patients in the
active control arm received 5-10 sessions of plasma
exchange. Efficacy and safety are monitored over a 6-month
period, post treatment. More information about the trial is
available at ClinicalTrials.gov under NCT03897205 (2019).
In November 2022, Hansa announced positive topline data
from the AMR study demonstrating a statistically
significantly superior capacity of imlifidase to rapidly reduce
levels of donor-specific antibodies (DSAs) compared to
plasma exchange in the five days following the start of the
treatment. These first results are another important
milestone in executing on Hansa’s strategy to expand the
reach of our IgG antibody cleaving technology platform to
address significant unmet medical needs in a wide spectrum
of disease areas and indications. We plan to publish the full
dataset from the AMR study in the second half of 2023.
1
Puttarajappa et al., Journal of Transplantation, 2012, Article ID 193724
2
Puttarajappa et al., 2012; Jordan et al., 2015
Graft loss if untreated
PLEX (Multiple rounds)
Imlifidase
Potential of using imlifidase vs. PLEX in AMR
Illustrative
Days
0
Clinical symptoms
2
3
4
5
6
7
8
9
1
Start of treatment
PLEX
Imlifidase
Level of Donor Specific Antibodies (DSAs)
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Guillain-Barré Syndrome (GBS)
Guillain-Barré Syndrome is an acute autoimmune attack
on the peripheral nervous system
GBS is an aggressive neurological disease of the peripheral
nervous system that affects 1-2 in 100,000 people, annually,
representing an addressable population of ~11,000 per year
in the seven major markets.
1
GBS is the most frequent cause
of acute neuromuscular weakness in the western world and
can affect anyone at any age and many patients deteriorate,
despite standard of care treatment.
Two thirds of GBS patients have severe symptoms, resulting
in an inability to walk unaided, and 20-30% require
mechanical ventilation for weeks or months
2
. While patients
are typically treated with either IVIg or plasmapheresis, a
significant unmet medical need remains, as not all patients
fully recover from GBS. Up to 40% of patients will lose
strength and have ongoing pain. Mortality is estimated at
between 3-5%.
3,4
Hansa is investigating imlifidase in an open-label, single arm,
multicenter phase 2 study evaluating the safety, tolerability
and efficacy of imlifidase in GBS patients, in combination
with standard of care intravenous immunoglobulin (IVIg). We
are targeting 30 GBS patients to be enrolled across clinics in
France, the UK and the Netherlands. GBS patients enrolled
in the study will receive a single dose of 0.25 mg/kg of
imlifidase and will be compared with a matched control
group of GBS patients treated with IVIg, from the
International GBS Outcome Study (IGOS) database.
Completion of enrollment in the GBS trial is anticipated H1
2023 with a first, high level data read out in the second half
of 2023.
1
Seven Major Markets Seven major markets include US, Germany, UK, France,
Spain, Italy, and Japan
2
Fletcher DD, Lawn ND, Wolter TD, et al. Long-term outcome in patients with
GuillainBarré syndrome requiring mechanical ventilation. Neurology
2000;54:2311–5
3
McGrogan et al.,” The Epidemiology of Guillain-Barré Syndrome Worldwide“,
Neuroepidemiology;2009, 32(2):150-63
4
van den Berg et al., 2014
Today’s Standard of Care IVIg or PLEX
Illustrative
Potential with imlifidase
Illustrative
-4
4
8
12
0
Paralysis
No weakness
Time from onset of weakness (weeks)
Infection
Course of GBS
Antibodies
-4
4
8
12
0
Paralysis
No weakness
Time from onset of weakness (weeks)
Infection
Course of GBS
Antibodies
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Exploration of Hematopoietic Stem
Cell Transplantation (HSCT)
1
https://ashpublications.org/blood/article/134/Supplement_1/2035/427903/
One-and-Half-Million-Hematopoietic-Stem-Cell
2
Ciurea et al. The European Society for Blood and Marrow Transplantation
(EBMT) Consensus Guidelines for the Detection and Treatment of
Donor-specific Anti-HLA Antibodies (DSA) in Haploidentical Hematopoietic
Cell Transplantation. Bone Marrow Transplant. 2018;53(5):521-534. Available
at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7232774/
Bone marrow cells from patients’ own body (no issues)
HLA-identical
sibling
HLA-matched
unrelated donor
Autologous HSCT
Haploidentical
donor
Allogenic HSCT
One such indication is allogeneic HSCT, also known as
“bone marrow” transplantation. Desensitization treatment
of patients with elevated levels of donor specific antibodies
(DSA) prior to allogeneic HSCT transplant is a challenge,
and currently there are no approved drugs to manage
these patients.
Allogeneic HSCT is a key, potentially curative treatment
intervention for patients with high-risk hematologic
malignancies, with over 50,000 HSCT transplants performed
annually, worldwide with approximately half being allogeneic
1
.
The preferred donor for patients is a human leukocyte
antigen, or HLA, matched individual. In the absence of
HLA-matched donors, or when an urgent transplant is
needed, haploidentical donors (siblings, parents, children) are
now increasingly considered for transplantation. Overall, in
haploidentical HSCT, the prevalence of donor-specific
anti-HLA antibodies varies according to published data and
may range between 10% and 21%
2
. This proportion is highly
dependent on the recipient’s gender, with low prevalence in
male recipients compared to female recipients, as a result of
sensitization during pregnancies.
It is our belief that our antibody-cleaving enzymes may have
the potential to transform the standard of care by enabling
clinicians to inactivate DSAs prior to transplantation thereby
creating the basis the basis for successful transplantation.
As part of the Company’s platform strategy and objective to broaden the application of our
antibody-cleaving enzymes as a potential therapy to change the course of IgG-mediated
immunological diseases and conditions, we are exploring new indications with high unmet need
Pre-existing DSAs may result in primary graft failure and poor survival
after allogenic hematopoietic stem cell transplantation
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6
44
Imlifidase in gene therapy – an emerging opportunity
45
Systemic gene therapy is an emerging opportunity
46
Neutralizing antibodies are a barrier that precludes gene therapies
47
Collaborations in gene therapy with Sarepta and AskBio
48
Research and preclinical development projects
New
opportunities
Imlifidase in gene therapy – an emerging opportunity
Genetic disorders are caused by defective genes which fail
to produce a functioning protein. Gene therapy treatments
are designed to introduce genetic material into cells to
compensate for these non-functioning genes. Thus, if a
mutated gene causes an essential protein to be faulty or
missing, gene therapy may be able to introduce a normal
copy of the gene to restore the gene function to produce the
desired protein.
In order to transfer a healthy and functioning gene into a
cell, non-replicating and non-disease causing viruses,
usually adeno-associated virus vectors (AAVs), are utilized.
The transfer and insertion of the healthy gene and its vector
into a cell is called transduction.
There are vectors that can be administered locally to
selected target tissues including specific cells in the eye
and the brain. There are also vectors that can be distributed
systemically, targeting liver or muscle cells. Since most
people have been exposed to adenoviruses at some point in
their lives, there is a relatively high prevalence of preformed
antibodies against AAVs. The prevalence of those
antibodies varies significantly between the different type of
vectors and can be as high as up to 70% in the general
population (e.g. AAV 1)
1
. The presence of antibodies against
AAV blocks the transduction, thus preventing successful
gene therapy treatment in those patients. This means that a
substantial proportion of patients are excluded from the
possibility of having a potentially disease-curing gene
therapy treatment.
We believe that imlifidase has the potential to eliminate
antibodies which can bind and inhibit gene therapy, thereby
enabling effective transfer of a healthy gene sequence into
these patients. The concept of using imlifidase as a
potential pre-treatment to overcome pre-existing antibodies
to AAV-based gene therapy was highlighted in “Nature
Medicine,” in 2020
2
. In particular, highly encouraging results
from preclinical studies were published, demonstrating that
imlifidase could eliminate the blocking effect of NAbs
towards AAVs in a mouse model, in non-human primates, as
well as in human plasma samples from patients with
antibodies against AAVs.
1
Boutin et al (2010), Griffin et al (2019), Wang et al (2018), Calcedo & Wilson
(2013), Falese et al (2017), Haiyan et al (2017), Ellsworth et al (2018), Greig et
al (2017)
2
Leborgne, C., Barbon, E., Alexander, J.M. et al. IgG-cleaving endopeptidase
enables in vivo gene therapy in the presence of anti-AAV neutralizing
antibodies. Nat Med 26, 1096–1101 (2020). https://doi.org/10.1038/
s41591-020-0911-7
Antibodies prevent effective transfer of
healthy gene sequence and can be a
safety concern
Imlifidase is a unique IgG antibody-cleaving
enzyme that cleaves IgG at the hinge region
with extremely high specificity
The idea is to eliminate the neutralizing
antibodies as a pre-treatment to enable
gene therapy
Nabs/IgG
Imlifidase
IgG
F(ab’)2
Fc
Neutralizing antibodies (Nabs) are immunological barriers in gene therapy
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Systemic gene therapy is an emerging opportunity
Rare monogenic diseases
From hundreds of patients to thousands of patients
DM-1
100,000
Astellas
Hemophilla
+55,000
Spark, BioMarin, uniQure,
Takeda, Pfizer, Freeline
Duchenne
20,000
Sarepta, Pfizer,
Astellas
OTC-
deficiency
20,000
Ultragenyx
SMA
+30,000
Novartis
Wilson
40,000
Viviet, Ultragenyx
Limb-
Girdle
20,000
Sarepta, Genethon,
AskBio
Fabry-
9,000
Freeline,
UniQure Sangamo
Pompe
10,000
Spark, AskBio,
Astellas
HAE
8,000
BioMarin,
Regenxbio
PKU
25,000
BioMarin
Late Preclinical
Clinical
Market
Preclinical programs with Sarepta and AskBio
Planned clinical study with Sarepta
Potential gene therapy indications (currently not pursued)
Circles indicate size of indications (US & EU)
AAV5 etc
1
AAV5 etc
1
AAV5 etc
1
AAV5 etc
2
AAV8 etc
4
AAV8 etc
3
AAV5, AAV6 etc
4
AAVrh74, AAV9 etc
3
AAV8 etc
5
AAV8 etc
2
AAV5 etc
1
1
NAbs: up to ~10%
2
NAbs: up to ~20%
3
NAbs: up to ~30%
4
NAbs: up to ~45%
5
NAbs: up to ~60%
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Prevelance of Nabs in AAVs
AAV 1
AAV 2
AAV 8
AAV 6
AAV 7
AAV 9
AAV 5
Up to 10%
Up to 20%
Up to 30%
Up to 30%
AAV-rh74
AAV 4
CNS, Eye,Skeletal muscle
CNS, Eye,Kidney
Liver, CNS, Heart, Eye, Pancreas, Skeletal muscle
Liver, Skeletal muscle
Liver, Skeletal muscle
Heart, Liver, Lung, Skeletal muscle
CNS, Liver,
Lung Eye
CNS, Eye, Skeletal muscle
Up to 2%
CNS,
Lung, Eye
1
Source: Boutin et al (2010), Griffin et al (2019), Wang et al (2018), Calcedo & Wilson (2013), Falese et al (2017), Haiyan et al (2017), Ellsworth et al (2018), Greig et al (2017)
Neutralizing antibodies are a barrier
that precludes gene therapies
Up to 45%
Up to 60%
Up to 60%
Up to 70%
The prevalence of Nabs varies significantly across the different vectors
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Collaboration with Sarepta Therapeutics
Since 2020 we have collaborated exclusively with Sarepta
Therapeutics to develop and promote imlifidase as a
potential pre-treatment prior to the administration of gene
therapy in Duchenne Muscular Dystrophy (DMD) and
Limb-Girdle Muscular Dystrophy (LGMD) in patients with
pre-existing NAbs to adeno-associated virus.
Under the terms of the agreement, Hansa received USD 10
million as an upfront payment and is eligible for up to USD
397.5 million in development, regulatory and sales
milestones, as well as royalties on any Sarepta gene therapy
sales enabled through pre-treatment with imlifidase in
NAb-positive patients. In addition, Hansa will book all future
sales of imlifidase when used as a pre-treatment.
The partnership is progressing as planned, with preclinical
investigations completed during 2022. In November 2022,
the two companies announced plans to initiate a clinical
study with imlifidase as a pre-treatment to Sarepta’s
SRP-9001 gene therapy in DMD in 2023. The announcement
followed an earlier release from Sarepta Therapeutics in
September 2022, in which Sarepta Therapeutics announced
that it had submitted a BLA to the U.S. FDA for the
accelerated approval of SRP-9001 to treat ambulant patients
with DMD.
In LGMD the collaboration is progressing as planned,
currently at a preclinical stage.
About Duchenne Muscular Dystrophy (DMD)
Duchenne muscular dystrophy is a rare genetic disease. It
predominantly affects males, but, in rare cases, can also
affect females. Duchenne causes the muscles in the body to
become weak and damaged over time and is eventually fatal.
The genetic change that causes Duchenne—a mutation in
the DMD gene—happens before birth and can be inherited,
or new mutations in the gene can occur spontaneously.
Muscle weakness becomes increasingly noticeable between
the ages of 3 and 5, and most patients use a wheelchair by
the time they are 12. During adolescence, heart and
breathing muscles weaken, leading to serious, life-threatening
complications. Duchenne affects approximately 1 in 3,500
to 5,000 males born worldwide. Approximately 15% of
patients have pre-existing IgG antibodies to AAVrh74.
About Limb-girdle muscular dystrophy (LGMD)
Limb-Girdle muscular dystrophy is a group of distinct
diseases that cause weakness and wasting of the muscles,
generally starting with the muscles around the hips and
shoulders and eventually progressing to the arms and legs.
However, some subtypes start distally at the leg or arm
muscles and then progress to the hip and shoulder muscles.
LGMD can be caused by a single gene defect that affects
specific proteins within the muscle cell, including those
responsible for keeping the muscle membrane intact. Taking
into account the various subtypes, limb-girdle muscular
dystrophy has a global prevalence of approximately 1.63 per
100,000 individuals worldwide. Over 30 subtypes exist, and
both genders are affected equally.
Collaboration with AskBio
Since January 2022 we have collaborated with AskBio
(subsidiary of Bayer AG), a fully integrated AAV gene therapy
Company dedicated to developing medicines that improve
the quality of life for patients with genetic diseases.
Collaborations in gene therapy with Sarepta and AskBio
To evaluate the feasibility of imlifidase as pre-treatment ahead of gene therapy for patients
with pre-existing neutralizing antibodies (NAbs) to adeno-associated virus (AAV)
The collaboration is designed to evaluate the potential use of
imlifidase as a pre-treatment prior to the administration of
AskBio’s gene therapy in Pompe disease in a preclinical and
clinical feasibility program for patients with pre-existing NAbs
to the adeno-associated viral vector used in AskBio’s gene
therapy. Under terms of the agreement, Hansa received a USD
5 million payment upon execution of the agreement and AskBio
has the exclusive option to negotiate a full development and
commercialization agreement following evaluation of the results
from an initial phase 1/2 study.
AskBio’s gene therapy candidate, AAV2/8-LSPhGAA, is being
investigated for the treatment of Pompe disease. This gene
therapy candidate combines AAV2 and AAV8 capsids, to
deliver a liver-specific promoter to express the GAA enzyme. It
is currently being investigated by AskBio in an open-label,
phase 1/2 study (ClinicalTrials.gov: NCT03533673), in which 8
patients with Late-Onset Pompe disease will be enrolled. For
further information regarding AskBio’s gene therapy program in
Pompe disease, please refer to www.askbio.com.
About Pompe disease
Pompe disease is a rare genetic, often fatal, disorder caused by
a defect in a gene making an enzyme called acid alpha-
glucosidase (GAA). GAA is used to break down glycogen (a
sugar used to store energy in cells) and a defect GAA enzyme
leads to accumulation of glycogen in the body’s cells. The
glycogen accumulation in certain organs and tissues,
especially muscles, liver and heart, severely impact normal
organ function. While enzyme replacement therapy (ERT) has
shown promise in patients with Pompe disease, no curative
therapy is available.
Pompe disease is estimated to affect 1 in 40,000 births in the
U.S.
1
, and equates to an incidence of ~200 per year in the U.S
and Europe. Additionally, data indicates that the prevalence of
Pompe disease in the U.S. and Europe, combined, is
approximately 10,000
2
. The percentage of patients that are
expected to have NAbs against the AAV8-vector components
used in AskBio’s gene therapy is 40-60%
3
.
1
Pompe disease, https://rarediseases.org/rare-diseases/pompe-disease/
2
Calculated by Hansa on the basis of incidence numbers from https://rarediseases.org/rare-diseases/pompe-disease/ and life expectancy estimates from https://
pompediseasenews.com/late-onset-pompe-disease/, as well as population statistics for the United States and European Union/Europe
3
ESGCT 27th Annual Congress Abstracts, Sensitivity of different AAV serotypes to pre-existing NAbs, https://www.esgct.eu/home/Barcelona%202019/
NEW_All%20Barcelona%20Abstracts.pdf & Boutin et al. Prevalence of serum IgG and neutralizing factors against adeno-associated virus (AAV) types 1, 2, 5, 6,
8, and 9 in the healthy population: implications for gene therapy using AAV vectors. Hum Gene Ther. 2010. https://pubmed.ncbi.nlm.nih.gov/20095819/
Hansa Biopharma Annual Report 2022
47
Overview
Strategy
Market
Technology
Growth
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
New
opportunities
Research and preclinical
development projects
“NiceR” program and lead candidate “HNSA5487”
– new set of enzymes for repeat dosing; potentially enabling
treatment of relapsing diseases.
Hansa is developing novel IgG-degrading enzymes under
the program name, “NiceR” (Novel Immunoglobulin Cleaving
Enzymes for Repeat dosing). The objective of the enzymes
developed from the NiceR program is to enable repeat
dosing in a broad array of indications with significant unmet
medical need including reoccurring transplantation,
relapsing autoimmune diseases and oncology, where
patients may benefit from more than one dose of an
IgG-modulating enzyme.
A broad repertoire of novel immunoglobulin cysteine
endopeptidases has been developed and patented within
the program and a lead candidate was selected in 2019 for
clinical development. At the end of 2022 Hansa announced
completion of IND-enabling toxicology studies and that a
CTA approval had been obtained for the lead candidate
“HNSA-5487” to start a first clinical trial in the first half 2023.
EnzE – Enzyme-based antibody Enhancement
Hansa is exploring EnzE as a potential therapeutic intervention
in oncology, in which imlifidase administration prior to
therapeutic antibody treatment may lead to a more efficient
anti-tumor therapy through cleaving the abundance of normal
IgG in blood. The project is currently in a research stage.
NiceR can potentially inactivate flares
Illustrative
flare 1
flare 2
flare 3
flare (n)
Time
Level of Pathogenic IgG
Hansa Biopharma Annual Report 2022
48
Overview
Strategy
Market
Technology
Growth
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
New
opportunities
Hansa Biopharma Annual Report 2022
49
Overview
Strategy
Market
Technology
Growth
New
opportunities
Directors’ report
Financials
Governance
Remuneration
Shareholder
information
50
Shareholder information
51
Ownership and analyst coverage
Shareholder
information
7
Shareholder information
Hansa share price development versus peer group
1
during 2022
0
20
40
80
60
100
120
1/22
2/22
3/22
4/22
5/22
6/22
7/22
8/22
9/22
10/22
11/22
12/22
XBI
Peer group
HANSA
1
Peer group consist of Scandinavian biotech/pharma companies with negative EBIT and 1-year average
market capitalisation of above 2 000m SEK (2022-02-14)
Hansa Biopharma’s shares are listed on Nasdaq OMX
Stockholm, under the ticker HNSA and are included in
several indexes including, but not limited to:
>
OMX Nordic Mid Cap
>
OMX Stockholm Health Care
>
OMX Stockholm Mid Cap
>
OMX Stockholm Pharmaceuticals & Biotechnology
>
STOXX Europe Total Market Small Index
Brief facts, the Hansa Biopharma-share
According to the shareholder register maintained by
Euroclear Sweden AB, as of 31 December 2022, Hansa
Biopharma had approximately 19,000 shareholders,
compared to approximately 18,000 shareholders as of
31 December 2021. Information regarding shareholders
and shareholdings is updated each quarter on the
Company’s website, www. hansabiopharma.com.
Share capital
Total shares issued as of 31 December 2022 amounted to
52,443,962 ordinary shares outstanding and 2,590,279
C-shares. At year end 2022, the share capital amounted to
SEK 55,034,241. At the general meeting, each ordinary share
entitles the holder to one vote and each shareholder may
vote the full number of shares held by him or her. All
outstanding shares are fully paid up. The Company’s share
capital is denominated in Swedish kronor (SEK) and divided
among the Company’s shares with a quotient value of SEK 1
per share.
Brief facts
Listing
Nasdaq OMX Stockholm
Number of shares
55,034,241 (52,443,962 A shares and
2,590,279 C-shares)
Market Cap December 31, 2021
SEK ~2.7bn (USD ~261m)
Ticker
HNSA
ISIN
SE0002148817
Price development for the HNSA share in 2021 and 2022
2022
2021
SEK
High
Low
High
Low
1st quarter
97.8
50.8
245.6
144.5
2nd quarter
70.5
47.5
180.9
132.2
3rd quarter
105.8
47.2
151.6
105.9
4th quarter
66.9
47.7
120.5
80.6
Hansa Biopharma Annual Report 2022
50
Overview
Strategy
Market
Technology
Growth
New
opportunities
Directors’ report
Financials
Governance
Remuneration
Shareholder
information
Ownership and analyst coverage
Top 10 largest shareholders, 31 December 2022
Owners
Number of shares
HNSA
Capital (%)
Redmile Group, LLC
10 896 553
20.8
Försäkrings AB Avanza Pension
2 209 783
4.2
Fjärde AP-Fonden (AP 4)
2 207 397
4.2
Nexttobe AB
2 155 379
4.1
Olausson, Thomas
1 917 000
3.7
Tredje AP-Fonden (AP 3)
1 389 650
2.6
Braidwell, L.P.
974 528
1.9
Handelsbanken Asset Management
908 266
1.7
C WorldWide Asset Management
799 749
1.5
Heights Capital Management, Inc.
667 169
1.3
Other
28 318 488
54.0
Total
52 443 962
100.0
Source: IHS Markit/IPREO compiled and processed data
from various sources, including Euroclear, Morningstar,
Factset and the Swedish Financial Supervisory Authority
(Finansinspektionen)
Analyst coverage 2022 and 2023
Analyst
Bank / Research institution
(year of initiation)
Location
Email
Phone
Christopher Uhde
SEB (2016)
Stockholm
christopher.uhde@seb.se
+46 (0) 876-385 53
Gonzalo Artiach
Castañón
ABG Sundal Collier (2018)
Stockholm
Gonzalo.Artiach@abgsc.se
+46 (0) 8 566 286 91
Zoe Karamanoli
RBC (2017)
London
zoe.karamanoli@rbccm.com
+44 7834 765119
Naresh Chouhan
Intron Health Research (2020)
London
naresh@intronhealthresearch.com
+44 7939 224 322
Douglas Tsao
H.C. Wainwright (2021)
New York City
dtsao@hcwresearch.com
+1 212-916-3968
Erik Hultgård
Carnegie (2019)
Stockholm
erik.hultgard@carnegie.com
+46 (0) 858-869 237
Johan Unnerus
Redeye (2008)
Stockholm
johan.unnerus@redeye.se
+46 (0) 724 023 385
Ludvig Svensson
Erik Penser Bank (2021)
Stockholm
ludvig.svensson@penser.com
+46 (0) 704 962 535
Lars Hatholt
Ökonomisk Ugebrev (2020)
Copenhagen
hatholt@outlook.com
+45 22 23 78 15
Ingrid Gafanhão
Bryan Garnier (2022)
Paris
ingrid.Gafanhao@kempen.com
+31 689 937 525
Suzanne van Voorthuizen
Kempen (2019)
Amsterdam
s.vanvoorthuizen@vanlanschotkempen.com
+31 6 29 71 3490
Ownership by type and location, 31 December 2022
Ownership by type
Ownership by country
22%
25%
53%
32%
7%
4%
57%
Investor type
Institutions
VC
High net-worth
Retail
Split by region
Sweden
United States
Europe
Hansa Biopharma shareholders
~19,000
As of 31 December 2022
Hansa Biopharma Annual Report 2022
51
Overview
Strategy
Market
Technology
Growth
New
opportunities
Directors’ report
Financials
Governance
Remuneration
Shareholder
information
Hansa Biopharma Annual Report 2022
52
Overview
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Financials
Governance
Remuneration
Directors’ report
53
2022 Directors’ report
Directors’
report
8
53
2022 Directors’ report
Operations
Hansa is a commercial-stage biopharmaceutical company pioneering the development and
commercialization of innovative, life-saving and life-altering treatments for patients with rare
immunological conditions.
The Company has developed a proprietary antibody-cleaving enzyme technology platform to
target pathogenic or disease-causing antibodies. Its broad therapeutic pipeline has potential
applications across transplantation, autoimmune diseases, gene therapy and oncology
indications addressing significant unmet medical needs.
Hansa’s first
-generation IgG-cleaving
enzyme, imlifidase, is designed to inactivate IgG antibodies in the plasma and tissue through a
single intravenous treatment. In 2020, Idefirix® (imlifidase) received conditional approval from
the European Commission for desensitization treatment of highly sensitized adult kidney
transplant patients, who may not otherwise be able to receive a new kidney. Additionally, the
Company is running a phase 3 study to support the approval of imlifidase in the U.S. for the
same indication.
Hansa is also currently evaluating imlifidase across a wide spectrum of both potential disease
areas and indications in an effort to address significant unmet medical needs. Its broad pipeline
spans pre-kidney transplantation desensitization and post-transplantation antibody-mediated
organ rejection, or AMR, and rare IgG-mediated autoimmune conditions such as anti-glomerular
basement membrane, or anti-GBM, antibody disease and Guillain-Barre Syndrome, or GBS, as
well as cancer.
Through collaborations with Sarepta Therapeutics, Inc. and Asklepios BioPharmaceutical, Inc.
(AskBio) Hansa is also evaluating imlifidase as a pre-treatment prior to gene therapy to
potentially allow the treatment of patients with pre-existing neutralizing antibodies against gene
therapy vectors. In addition, Hansa entered a preclinical research collaboration with argenx BV
to evaluate the therapeutic potential of combining the two companies’ IgG
-modulating
technologies.
Beyond imlifidase, the Company is also pursuing a second-generation IgG-cleaving enzyme
program, NiceR. It is designed to enable expansion into a large spectrum of potential
indications, including relapsing autoimmune diseases and gene therapy, as well as oncology
indications. Through its preclinical EnzE program, Hansa is exploring the potential of an IgG-
cleaving agent as a pre-treatment for cancer therapy.
Hansa Biopharma is headquartered in Lund, Sweden, is listed on Nasdaq Stockholm, and also
has operations in other European countries and in the U.S.
2022 Business review
2022 was a successful year at Hansa with solid performance and strong progress across the
organization. Hansa executed throughout the year on key priorities, including R&D, commercial
and operations.
The Company progressed the launch of and market access efforts for Idefirix
®
in Europe,
securing reimbursement in a number of additional important markets, such as Germany, the
UK, France and Italy. Market access is now secured in 11 European countries, including four of
the five largest markets.
Outside the EU Hansa recently signed a distribution agreement with
iQone Healthcare, a leading Swiss healthcare product supplier, to cover the distribution of
Idefirix® in Switzerland. Product sales in 2022 increased by almost 6-fold compared to 2021
and reached SEK 87 million, while total revenue increased to SEK 155 million.
Also, the first medical guidelines for desensitization treatment of highly sensitized kidney
transplant patients were published by the European Society for Organ Transplantation (ESOT).
These guidelines are the first to include Idefirix
®
and represent the first international consensus
on a management pathway for kidney transplant patients with high unmet need.
On the development side, Hansa continued to make progress across its pipeline.
In November, the Company presented top-line data from its phase 2 program in AMR, post
transplantation, demonstrating significantly superior capacity of imlifidase to rapidly reduce DSA
levels in comparison to plasma exchange in the five days following the start of the treatment.
The full data set from the phase 2 study in AMR is planned to be published in the second half of
2023.
Hansa also continued to progress recruitment into its ConfIdeS study, the ongoing pivotal,
phase 3 trial in kidney transplantation in the US. As of February 1, 2023, 51 out of the targeted
64 patients were enrolled for randomization in that study. A potential BLA submission is
targeted for 2024. Further, recruitment into the ongoing phase 2 study in GBS continued to
progress with enrolment reaching 25 out of targeted 30 patients as of February 1, 2023 and an
expected completion of enrolment during the first half of 2023.
In addition, the Company initiated two new phase 3 studies, namely the European Post
Approval Efficacy Study in kidney transplantation, a key study under the EMA post-approval
commitments and the pivotal, global phase 3 study in anti-GBM disease building upon the
strong results from the phase 2 investigator-initiated trial completed in 2020.
On the pre-clinical side, significant achievements were accomplished during 2022; specifically,
in the DMD program with Sarepta Therapeutics in gene therapy and in the NiceR program,
which is exploring utilisation of second-generation enzymes for repeat dosing. With regard to
the NiceR program, the lead compound HNSA-5487, has successfully completed IND-enabling
toxicology studies during 2022 and is now expected to enter the clinic in the first half of 2023.
And with regard to the DMD program, following successful pre-clinical work, Hansa and Sarepta
announced plans to initiate a clinical study with imlifidase as a pre-
treatment to Sarepta’s SRP
-
9001 gene therapy in DMD in 2023.
54
2022 Directors’ report
continued
Through the agreement with AskBio, a subsidiary of Bayer AG, announced in January 2022 to
evaluate imlifidase in a pre-clinical and clinical feasibility program as pre-treatment ahead of
gene therapy in Pompe disease in patients with pre-existing neutralizing antibodies (Nabs),
Hansa further expanded its potential footprint in the gene therapy space.
A key focus of Hansa during 2022 was also to secure additional financing. Despite challenging
capital markets throughout 2022, the Company successfully completed a USD 70 million non-
dilutive debt financing in July and a USD ~40 million equity financing in December 2022,
extending its cash runway into 2025.
And finally, Hansa continued to build a high-performance team by attracting and integrating
highly talented and experienced candidates, while creating a rewarding, productive and
stimulating workplace for its employees. The progress the Company is making was again
evidenced in 2022
as it received certification as a “Great Place to Work” for the
third
consecutive year by the GPTW Institute.
However, beyond the significant achievements during 2022, the Company has also seen its
commercialization and pipeline activities, specifically related to the recruitment of patients in the
ongoing studies, still negatively impacted by issues resulting from the COVID-19 pandemic.
Risk management
Hansa is committed to effective risk management. Risk management is recognized as an
integral part of good management practice and is a basis for the Company to achieve its
objectives and strategies. Hansa´s risk management policy was launched in 2015 and
substantially revised in 2020.
The policy forms part of Hansa’s quality management system
and
is reviewed on a regular basis. It provides management with a facilitating framework of
guidance wh
en dealing with risks inherent in achieving the organization’s objectives and
,
specifically, to:
>
Establish a common organizational approach to risk management to ensure consistent and
efficient risk identification, assessment, and control
>
Raise awareness of the need for risk management
>
Integrate risk management into the Company culture and processes
>
Establish defined roles, responsibilities, and reporting structures for risk management
Hansa’s executive management and the Board of Directors regularly discuss the Company’s
key risks and respective risk management.
Risk factors
Hansa’s business is influenced by several factors, the effects of which on the Company’s
earnings and financial position, in certain respects, cannot be controlled by the Company at all
or in part. In an assessment of the Company’s future development and business prospects, it is
important, alongside the possibilities for growth in earnings, to also consider these risks.
Set forth below is a description, without any internal order of priority, of the risks which are
considered to have the highest level of significance on the Company’s future development. For
natural reasons, not all the risk factors can be described. Instead, the risks which are specific to
the Company, or the industry are set forth here. It is important to also note that the significance
of risks may change over time
risks which are not considered significant may become
significant over time despite not being listed below. An overall assessment must also include
other information contained in the annual report as well as an overall assessment of extraneous
factors in general.
Risks related to public health crisis and geopolitical factors
The global outbreak of COVID-19 did have and partly still has significant negative impact on
economies and businesses globally. A continued and prolonged public health crisis such as the
COVID-
19 pandemic could have a material negative impact on the Company’s business,
financial condition, and operating results. To the extent any potential future public health crisis
adversely affects the Company’s business and financial results, it may also have the effect of
heightening many of the other risks described in this “Risk Factors” section, such as those
relating to the Company’s clinical development, the supply chain for the Company’s
commercial
and clinical supply, the availability of governmental and regulatory authorities, and the success
of the Company’s commercial
operations in Europe and potential other territories.
In February 2022, Russia invaded Ukraine. Hansa does not have any operations in nor
collaborations with any third-party service providers from either Ukraine or Russia. Therefore,
Hansa’s operational activities
are not directly affected by the conflict. However, the conflict did,
and is expected to continue to have general negative impacts on the global economy, stock
markets, exchange rates, energy prices, global supply, and free trade, and, as such, does
indirectly negatively impact Hansa’s business.
Any potential future geopolitical crises may have
significant negative impact on Hansa’s business
and business partners.
Product development, regulatory approval, and commercialization
The Company operates procedures to secure the integrity and protection of its R&D and
commercial activities and data, and to optimize allocation of budgets and resources.
Nevertheless, due to limited resources and access to capital, the Company must and have in
the past decided to prioritize development of certain product candidates; these decisions may
prove to have been wrong and may adversely affect Hansa’s business. The Company is heavily
dependent on the success of its product candidate imlifidase. Hansa is also dependent on the
success of its other product candidates, for example in the NiceR program.
The Company cannot give any assurance that any product candidate will successfully complete
clinical trials or receive regulatory approval, which is necessary before it can be commercialized.
Hansa’s business and future success is substantially dependent on its ability to develop
successfully, obtain regulatory approval for, and then successfully commercialize its product
candidate imlifidase and its other product candidates. Hansa is not permitted to market or
promote any of its product candidates before it receives regulatory approval from the FDA, the
55
2022 Directors’ report
continued
EMA or any other comparable regulatory authority, and Hansa may never receive such
regulatory approval for any of its product candidates, or, if approved, such approval may be
revoked if an approved product is later found to be unsafe or lack efficacy.
The Company cannot give any assurances that its clinical trials for imlifidase or its other product
candidates will be completed in a timely manner, or at all. If imlifidase or any other product
candidate is not approved and/or commercialized, Hansa will not be able to generate any
revenues for that product candidate.
The regulatory approval processes of the FDA, the EMA and other comparable regulatory
authorities are lengthy, time consuming and inherently unpredictable, and if the Company is
ultimately unable to obtain (full) regulatory approval for its product candidates, Hansa’s
business will be substantially harmed.
Clinical testing is expensive and does take many years to complete, and its outcome is
inherently uncertain. Results of earlier studies and trials as well as data from any interim
analysis of ongoing clinical trials may not be predictive of future trial results and failure can
occur at any time during the clinical trial process. If Hansa experiences delays in the completion
of any clinical trial of its product candidates, the commercial prospects of the product candidates
may b
e significantly harmed, and Hansa’s ability to generate revenues from any of these
product candidates will be delayed and/or significantly reduced. If imlifidase or any other
product candidate is found to be unsafe or lack efficacy, Hansa will not be able to obtain
regulatory approval for it and its business will be materially harmed.
The rates at which Hansa completes its scientific studies and clinical trials depend on many
factors, including, but not limited to, patient enrolment. Patient enrolment is a significant factor in
the timing of clinical trials and is affected by many factors including competing clinical trials,
clinicians’, and patients’ perceptions as to the potential advantages of the drug being studied in
relation to other available therapies and the relatively limited number of patients. Any of these
factors may harm Hansa’s clinical trials and by extension, Hansa’s business, financial
condition,
and prospects.
The Company’s product candidates may cause undesirable side effects or have other
properties that could delay or prevent their regulatory approval, limit the commercial profile of an
approved label, or result in significant negative consequences following potential marketing
approval. Undesirable side effects caused by our product candidates could cause Hansa or
regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive
label or the delay or denial of regulatory approval, or if approved, market withdrawals, by the
FDA, the EMA, or other comparable regulatory authorities. The drug-related side effects could
negatively affect patient recruitment or the ability of enrolled patients to complete a trial, the
commercial prospects or result in potential product liability claims. Any of these occurrences
may harm Hansa’s business, financial
condition, and prospects significantly. Box warnings,
labelling restrictions, dose limitations and similar restrictions on use could have a material
adverse effect on Hansa’s ability to commercialize imlifidase
or any other product candidate, if
approved, in those jurisdictions where such restrictions apply.
If the Company is not able to maintain orphan product exclusivity for imlifidase or obtain such
status for other or for future product candidates for which it seeks this status, or if the
Company’s competitors are able to obtain orphan product exclusivity before the Company does,
it may not be able to obtain approval for Its competing products for a significant period of time.
Hansa’s commercial success depen
ds upon attaining significant market acceptance of its product
candidates, if approved, among physicians, healthcare payers, patients, and the medical
community. Coverage and reimbursement decisions by third-party payers may have an adverse
effect on pricing and market acceptance. Legislative and regulatory activity may exert downward
pressure on potential pricing and reimbursement for any of Hansa’s commercial products and/or
product candidates, if approved, that could materially affect the commercial opportunity.
Collaboration and partnerships
The Company has entered and may in future enter into agreements with 3rd party partners
related to the research, development and/or commercialization of Hansa’s product candidates
and/or commercial products, such as with argenix BV, Sarepta Therapeutics, Inc., Medison
Pharma, IQone Healthcare Switzerland and Asklepios BioPharmaceutical, Inc. Such
partnerships and agreements may be terminated, unsuccessful, not achieve the intended
results and outcomes, not mee
t Hansa’
s objectives or expectations, and therefore materially
negatively impact Hansa’s business, its financial
position, and earnings prospects.
Reliance on Contract Manufacturing Organisations (CMOs)
The manufacturing and packaging process for imlifidase is made in collaboration with contract
manufacturers/packagers in Europe.
Hansa is dependent on the quality of the manufacturing and packaging processes, as well as
the availability and maintenance of the production facilities. Regulatory authorities require that
all manufacturing processes and methods, as well as all equipment, comply with current
requirements of Good Manufacturing Practice (GMP) and consequences for the Company in the
event of deficiencies in GMP requirements, and potential withdrawal of approval from the
regulatory authorities, in the respective territories, for those facilities providing the services, may
lead to delays in or the inability to supply the product for clinical trials or commercialization
which will negatively affect th
e Company’s earnings and future prospects. In addition to the
compliance risk of our collaborators, the Company is exposed to business continuity risk as our
collaborator’s facilities might be damaged, destroyed or not have sufficient capacity for other
reasons. This may lead to the Company not being able to continue clinical trials or sell its
products which will
negatively affect the Company’s earnings and future prospects.
56
2022 Directors’ report
continued
Reliance on Contract Research Organisations (CROs)
The Company has relied upon and will continue to rely upon third-party contract research
organizations, or CROs, to conduct, monitor and manage its preclinical and clinical programs. The
Company relies on these parties for execution of its preclinical studies, analytical and laboratory work,
data management and analysis, and clinical trials and controls only certain, limited aspects of the
CRO’s activities. Nevertheless, the Company is responsible for ensuring that each of its trials is
conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific
standards and its reliance on a CRO or any other vendor does not relieve Hansa of its regulatory
responsibilities. If Hansa or any of its CROs or vendors fail to comply with applicable regulations, the
data generated in Hansa’s preclinical studies, analytical and laboratory work and/or clinical trials may
be deemed unreliable, and the EMA, FDA or other regulatory authorities may require Hansa to
perform additional preclinical studies, analytical and laboratory work and/or clinical trials before
approving Hansa’s marketing applications.
If any of the relationships with these third-party CROs terminates, the Company may not be able to
enter into arrangements with alternative CROs or do so on commercially reasonable terms.
If CROs do not successfully carry out their contractual duties or obligations or meet expected
deadlines, if they need to be replaced or if the quality or accuracy of the data, they obtain is
compromised due to the failure to adhere to Hansa’s protocols, regulatory requirements or for
other reasons, Hansa’s pre
-clinical and/or clinical trials may be extended, delayed, or
terminated, and the Company may not be able to obtain regulatory approval for or successfully
commercialize its product candidates. CROs may also generate higher costs than anticipated.
As a result, the Company’s results of operations and the commercial prospects for its product
candidates would be harmed, Hansa’s costs could increase, and the Company’s ability to
generate revenue could be delayed.
Intellectual property
The value of Hansa Biopharma is largely dependent on its ability to obtain and defend patents
and its ability to protect specific know-how. Patent protection for biomedical and biotech
companies may be uncertain and involve complicated legal and technical questions. There is
significant risk that a patent sought will not be granted for an invention, that the patent granted
will not provide sufficient protection, or that the patent granted will be circumvented or revoked.
If the Company fails to obtain and/or maintain patent protection and trade secret protection of its
product candidates and/or commercial products, it could lose its competitive advantage and the
competition the Company faces would increase, reducing or eliminating any potential revenues
and adversely affecting its ability to attain or maintain profitability, impacting the Company’s
future prospects and valuation significantly.
Dependence on key product
The Company has a thin and concentrated pipeline. The value of the Company is primarily
dependent on success in the Company’s leading development product candidate, imlifidase.
The market value of the Company, and thus the Company’s share
price, would be significantly
negatively impacted or entirely lost by setbacks related to imlifidase.
Market and competition
The product candidates Hansa has under development and any commercial product, risk being
exposed to competition from new pharmaceuticals and/or diagnostic methods. Developing a
new pharmaceutical from invention to finished product requires a long time. Not the least for this
reason, when development is underway it is uncertain whether there will be any market for the
product when it is finally developed and, in such case, how large this market will be, as well as
which competing products the Company’s products will encounter when they reach the market.
To the extent competition consists of existing preparations or methods, Hansa’s suc
cess is
dependent on its ability to induce potential customers to replace known products or methods
with those of Hansa.
Another risk is that competitors, who in many cases have greater resources than the Company,
will develop alternative preparations that are more effective, more secure, or cheaper than
those offered by Hansa. This may lead to the Company facing limited sales or not being able to
sell its products at all which may negatively affect the Company’s earnings.
Pricing and reimbursement
On many markets, purchases of pharmaceuticals of the type being developed or
commercialized by the Company are financed, in whole or in part, by a party other than the
patient, for example, caregivers, insurance companies or governmental authorities subsidizing
pharmaceuticals. If the Company does not achieve acceptance for its commercial products and
pricing and reimbursement of the products by such financiers, this may make it more difficult or
impossible for the products to reach the market and may prejudice their commercial potential,
which may negatively affect the Company’s earnings and financial position.
Dependence on key persons
Hansa is, to a high degree, dependent on key persons, both employees as well as directors.
The Company’s future earnings are affec
ted by its ability to attract and retain qualified key
persons. In cases where one or more key persons leave the Company and the Company is not
successful in replacing such person(s), this might harm the Company’s business, financial
position and earnings.
Financial risks
Hansa carries out capital-intensive and value generating pharmaceuticals development and
commercialization. Future financing of its operations is expected to take place either through
new issues of shares, loans, structured financing, convertible bonds, licensing revenue,
cooperation with other parties, the sales of rights and/or patents or a combination of any the
above. The Company has, since the start of its operations, incurred net losses and cash flow is
expected to remain negative until the Company generates substantial revenues from any
marketed product. The Company has historically financed its operations primarily through equity
financings, and in addition, in 2022, took up a long-term loan to help financing future operations.
57
2022 Directors’ report
continued
The Company has devoted substantially all of its resources on, inter alia, raising capital,
organizing and staffing the company, business planning, development, regulatory approval and
commercialization of imlifidase and other candidates and protecting the Company’s intellectual
property portfolio. The Company expects that it will be several years, if ever, before the
Company has commercialized imlifidase in any jurisdictions other than Europe or any other
product candidates. The Company expects to continue to incur significant expenses and
increasing operating losses for the foreseeable future.
If the Company is not able to continue to finance its operations this may result in the Company
being unable to continue operations and as a result significantly harm the value of the Company
and thus the share price of the Company. For further description of the Company’s financial
risks, see Note 20 to the Consolidated Financial Statements.
Sustainability and social responsibility
Hansa leverages its unique enzyme technology platform to develop innovative, lifesaving and
life altering immunomodulating therapies, bring these to the patients with rare diseases who
need them, and generate value to society at large.
The Company is committed to driving its business forward in a sustainable way. In 2022, Hansa
conducted a stakeholder engagement and material assessment and developed a strategic
approach to align with the United Nations (UN) Sustainable Development Goals - action for
people, the planet, and prosperity. Hansa also took into consideration the Global Reporting
Initiative’s (GRI) reporting standard. You can find the Company’s
2022 Sustainability Report on
its website at
www.hansabiopharma.com
, including its impact on economy, people, and
environment.
Employees
Personal development
Equality & Inclusion
Work environment
At Hansa, employees are the most valuable asset. They play a key role in reaching the
Company’s vision. Hansa strives to attract and keep the best talent. It values and promotes
equality and inclusion in its workforce and across its global leadership. Hansa offers a range of
personal and professional development opportunities such as, for example, career changes
within Hansa, new project management roles, trainings and Hansa Academy. Hansa takes
responsibility by ensuring good working conditions in a healthy and sustainable work
environment.
Please refer to
Hansa’s Sustainability Report at www.
hansabiopharma.com
Revenue and financial result for the Group
The Group consists of the parent company, Hansa Biopharma AB and the subsidiaries Cartela
R&D AB, Hansa Biopharma Ltd, Hansa Biopharma Inc. and Hansa Biopharma Australia PTY
LTD. Hansa Biopharma Inc had six employees at the end of December 2022. Hansa Biopharma
Ltd owns patent rights to the EnzE concept and had four employees at the end of December
2022.
Revenue for 2022 amounted to SEK 154.5 million (2021: SEK 33.9m) and comprises of product sales
in the amount of SEK 86.7 million (2021: 15.0m), revenue recognition from the upfront payment the
Company received under the Sarepta and AskBio agreements in the amount of SEK 64.3 million
(2021: 15.7m), and royalty income and cost reimbursements from Axis-Shield Diagnostics (Abbott
group) in an amount of SEK 3.5 million (2021: 3.2m).
The loss from operations for 2022 amounted to SEK 588.6 million (2021: SEK 547.0m). Compared
to 2021, 2022 expenses have increased primarily in line with the progress in and expansion of
Hansa’s R&D activities
; more specifically, the ongoing ConfIdeS study in the U.S., the post-
approval commitments in Europe and the preparations for the pivotal phase 3 program in anti-
GBM disease. Further, Hansa did also increase its investments into its second-generation enzyme
program in preparation of taking the lead candidate HNSA-5487 into the clinic in 2023. The result
for 2022 includes non-
cash expenses related to the Company’s long
-term incentive programs
(LTIP) amounting to SEK 58.2 million (2021: SEK 56.6m).
Finance income for 2022 amounted to SEK 27.2 million (2021: SEK 0.1m) and is mainly resulting
from foreign exchange rate gains, particularly USD and EUR, and interest income. Finance
expenses amount to SEK 48.6 million (2021: SEK 1.2m) and mainly relate to interest expenses
related to the long-term loan taken-up in 2022 and changes in fair value of interest fund
investments Hansa held during a part of 2022.
The loss for 2022 amounted to SEK 611.1 million (2021: SEK 548.3m).
Cash flow and financial position
Net cash used in operating activities amounted to SEK 502.7 million in 2022 (2021: 481.2m).
The increase in cash consumption is in line with the growth
in Hansa’s R&D investments
, partly
offset by increased product sales.
In July 2022, Hansa completed a non-dilutive debt-financing of USD 70 million and in December
2022 it raised USD ~40 million by the placement of 7.8 million ordinary shares in a directed
share issue. Together, the two financing events contributed SEK 1,124.6 million in proceeds net
of transaction cost.
Cash and cash equivalents including short term investments amounted to SEK 1,496.2 million
as of December 31, 2022 (SEK 889.0m as of December 31, 2021), which is expected to finance
Hansa’s operations into 202
5.
Capital expenditures
Capital expenditures during 2022 amounted to SEK 3.3 million (2021: SEK 2.4m).
Shareholders’ equity
On December 31, 2022, shareholders equity amounted to SEK 602.9 million compared to SEK
757.6 million at the end of the financial year 2021.
58
2022 Directors’ report
continued
Parent Company
The Parent Company’s revenue for 202
2 amounted to SEK 154.5 million (2021: SEK 33.9m).
The loss for the period for the Parent Company amounted to SEK 596.7 million for 2022 (2021:
SEK 549.1m). On December 31, 2022, cash and cash equivalents including short-term
investments amounted to SEK 1,486.5 million compared to SEK 882.6 million at the end of the
year 2021.
The Parent Company’s shareholders equity amounted to SEK
615.8 million as per December
31, 2022, compared to SEK 755.9 million at the end of 2021.
Five-year summary,
consolidated for the Group
KSEK, unless other stated
2022
2021
2020
2019
2018
Revenue
154,525
33,878
6,098
3,364
3,358
Sales, general and
administration
expenses
(337,861)
(327,269)
(202,987)
(167,310)
(90,387)
Research and development
expenses
(346,244)
(230,764)
(227,191)
(192,949)
(154,558)
Other operating income (expenses)
(20,532)
(7,398)
2,270
(1,907)
(3,995)
Loss from
operations
(588,588)
(546,978)
(422,807)
(359,668)
(246,498)
Loss for the period
(611,134)
(548,282)
(420,853)
(360,009)
(247,974)
Net cash used in operating activities
(502,733)
(481,168)
(290,274)
(334,775)
(204,560)
Cash and cash
equivalents,
including short
-term investments
1,496,179
888,961
1,377,506
601,094
858,187
Shareholder’s equity
602,912
757,573
1,242,124
562,815
859,876
Earnings per share before and after
the dilution (SEK)
(13.60)
(12.33)
(9.98)
(9.00)
(6.47)
Number of outstanding shares at the
end of the period
52,443,962
44,473,452
44,473,452
40,026,107
39,959,890
Weighted average number of shares
before and after dilution
44,923,998
44,473,452
42,176,872
40,020,429
38,326,098
Number of FTE’s end of the
period
150
131
87
74
52
Share capital and ownership
The Company is authorized to issue 80,000,000 shares. Two classes of shares may be issued,
ordinary shares (Class A) and Class C shares and together they may not exceed 80,000,000.
Total shares issued as of 31 December 2022 comprised of 52,443,962 ordinary shares and
2,590,279 C-shares held by the Company as treasury shares. During 2022 the Company issues
7,848,111 new ordinary shares and issued and repurchased 850,769 C-shares, held as
treasury shares. Each share has a nominal value of SEK 1 resulting in SEK 55,034,241 share
capital and SEK 52,443,962 in outstanding share capital as of 31 December 2022.
At the general meeting, each ordinary share entitles the holder to one vote and C-shares to one
tenth of a vote each. C shares are not entitled to dividends. Each shareholder may vote the full
number of shares he
ld by him or her. The Company’s share capital is denominated in Swedish
kronor (SEK) and divided amongst the Company’s outstanding shares with a quotient value of
SEK 1 per share. As per December 31, 2022, the single largest shareholder in Hansa was
Redmile Group LLC, with a total of 10,896,553 shares, representing 20.8 percent of the voting
rights and the outstanding share capital.
Share-based compensation programs
Hansa uses share-based long-term compensation programs to create conditions for motivating
and retaining key employees and to align interests and long-term objectives between the
shareholders and the Company, as well as to incentivise meeting and exceeding the
Company’s business and financial
targets.
As in certain previous years, and upon the proposal of Hansa
’s
Board of Directors, the AGM
resolved to adopt a long-term, share-based compensation program in 2022.
2022 Long-term incentive program
Hansa
’s Annual General Meeting (the “AGM”) on
June 30, 2022 resolved to adopt a long-term
incentive program, LTIP2022, based on (a) performance-based share rights and (b) employee
stock options.
LTIP2022 based on performance-based share rights
Under the terms of LTIP2022 key employees may participate in the program and may receive
so-called performance-based share awards free-
of charge (a “Share Right”) which, provided
certain pre-defined Performance Conditions (as briefly summarized below) and other criteria are
met, give the participants the right to acquire ordinary shares in Hansa Biopharma AB at no
cost. Each Share Right represents the right to acquire one share in Hansa Biopharma AB and
carries a vesting period of three years commencing on the day of its allotment to a participant
(the “Vesting Period”).
59
2022 Directors’ report
continued
The final number of shares a participant is entitled to receive is, amongst other terms,
conditional upon if or to what extent the following performance conditions are met during the
Vesting Period (the
”Performance Conditions”):
>
Condition 1: U.S. FDA has approved imlifidase in the U.S. in any indication
>
Condition 2: Imlifidase has been approved, or a Marketing Authorization Application/Biologics
License Application has been submitted, in any jurisdiction in an indication outside kidney
transplant
>
Condition 3: More than 80 per cent of the targeted transplantation centers in Europe had
repeat business, i.e. used Idefirix
®
more than once
>
Condition 4: Total shareholder return of at least 25%
A maximum of 624,615 Share Rights may be allotted to participants under the LTIP 2022 from
the day following the 2022 AGM up and until the day prior to the AGM in 2023.
As of December 31, 2022, 543,000 Share Rights have been allotted to plan participants.
LTIP2022 based on stock options
The 2022 AGM also resolved to adopt an employee stock option program under the terms of
LTIP2022. Senior executives may participate in the program and receive employee stock
options free-of-charge.
Each employee stock option entitles the holder to receive one new ordinary share in Hansa
Biopharma AB at an exercise price of SEK 70.00 corresponding to 125 per cent of the volume
weighted average share price during the 30 trading days immediately prior to the offer to
subscribe for the employee stock options, and provided that the participant, with certain
exceptions, from the date of the start of participation in LTIP 2022 up until and including the
date three years thereafter (the Vesting
Period) maintains his or her employment within the
Group.
A maximum of 452,307 employee stock options may be allotted to participants under the
LTIP2022 from the day following the 2022 AGM up and until the day prior to the AGM in 2023.
As of December 31, 2022, 384,000 employee stock options have been allotted to the plan
participants under the LTIP2022.
Expenses related to share rights and employee stock options are reported in accordance with
IFRS 2. The total expenses including social security contributions (based on social security tax
of 31.4 percent) for the share rights and options under LTIP2022 allotted as of December 31,
2022, is expected to amount to approximately SEK 66.8 million, of which SEK 10.2 million is
included in the results for the Group for the year 2022.
Please refer to Notes 2 and 14 for further information and previously adopted share-based
compensation programs.
2022 Guidelines for remuneration to senior executives
A prerequisite for the successful implementation of the Company’s business strategy and
safeguarding of its long-term interests, including its sustainability, is that the Company is able to
recruit and retain qualified personnel, consequently, it is necessary that the Company offers
market competitive remuneration.
The guidelines adopted by the 2022 annual general meeting entail that senior executives, i.e.
the CEO and members of the executive committee, will be offered remuneration which is
competitive and on market terms. The level of the remuneration for the individual senior
executive shall be based on factors such as complexity and responsibility of the position,
expertise, experience, and performance. The remuneration consists of a fixed base salary and
pension benefits and, in addition, may consist of a variable cash remuneration, performance-
based short-term incentive (STI), share based long-term incentive programs (LTIP) as resolved
by a general meeting, severance remuneration, and other benefits. The STI shall be based on
the achievement of quantitative and qualitative performance targets and shall not exceed 75
percent of the annual fixed base salary. The variable cash remuneration is intended to support
recruitment or retention of key personnel or to reward extraordinary performance beyond the
individual’s ordinary responsibilities and shall not exceed 30% of the annual fixed base salary.
Contributions to pension plans shall not exceed 30% of the annual fixed base salary. Salary
during the notice of termination period and severance remuneration shall be possible in a total
maximum amount of 18 monthly base salaries.
Ultimate responsibility for the remuneration to senior executives as well as setting the
respective performance targets lies with the Board of Directors which is supported by the
Remuneration Committee and the CEO.
Please refer to the Remuneration Report elsewhere in this Annual Report for further information
on remuneration to senior executives.
2023 proposed changes to remuneration guidelines for senior executives
No changes to the guidelines are proposed for 2023.
Dividend
The Board proposes that no dividend will be paid for the financial year 2022. For more
information about Hansa Biopharma’s dividend policy, please refer to the Hansa Biopharma
Corporate Governance Report available on the Company’s website at
https://hansabiopharma.com/this-is-hansa/corporate-governance/
Other information
For additional information, please see the Corporate governance report and the Remuneration
repor
t on the Company’s website or elsewhere in this Annual
Report.
60
2022 Directors’ report
continued
Annual general meeting 2023
The annual general meeting of Hansa Biopharma AB (publ) will take place on June 14, 2023.
Notice to attend the annual general meeting will be published on Hansa Biopharma’s website at:
www.hansabiopharma.com.
Financial calendar 2023
March 30, 2023
Annual Report 2022
April 20, 2023
Interim report for January - March 2023
June 14, 2023
Annual General Meeting 2023
July 20, 2023
Half year 2023 report
October 18, 2023
Interim Report for January-September 2023
Appropriation of loss carried forward
Unrestricted shareh
olders’ equity in the Parent Company
SEK
Share premium reserve
3,021,541,484
Treasury shares
(2,590,279)
Loss carried forward
(1,882,303,903)
Result for the year
(596,735,718)
Total
539,911,584
The Board of Directors proposes that the loss carried forward and unrestricted
reserves to be allocated as follows
SEK
Share premium reserve
3,021,541,484
Treasury shares
(2,590,279)
Profit/loss carried forward
(2,479,039,621)
Total
539,911,584
The Group’s and the Parent Company’s
results and financial position are shown in the following
section “Financials”
further below in this Annual Report, which includes the accompanying notes
and supplementary information, which are an integral part of the financial statements.
Address
Hansa Biopharma AB (publ)
Scheelevägen 22, SE-223 63 Lund, Sweden
Postal address
P.O. Box 785, SE-220 07 Lund, Sweden
Registration number
556734-5359
Hansa Biopharma Annual Report 2022
61
Overview
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Governance
Remuneration
Financials
62
The Group Financial Statements
66
Notes to the Group Financial Statements
97
Parent Company Financial Statements
101
Notes to the Parent Company Financial Statements
110
Definitions
111
Signatures
112
Auditor’s Report
Financials
9
62
The Group Financial Statements
Consolidated statement of financial position
As of December 31,
(in thousands of SEK)
Note
2022
2021
ASSETS
Non-current
assets:
Intangible assets
4
46,866
28,761
Property and equipment
5
8,113
6,432
Right-of-use assets
6
27,723
35,273
Total non-current assets
82,702
70,466
Current assets:
Inventories
7
973
242
Trade receivables & unbilled revenues
8,13
42,959
9,712
Prepaid expenses and accrued income
9
33,278
20,889
Other receivables
10
31,315
22,538
Short-term investments
20
-
237,619
Cash and cash equivalents
20
1,496,179
651,342
Total current assets
1,604,704
942,342
TOTAL ASSETS
1,687,406
1,012,808
EQUITY
Share capital
23
55,034
46,335
Share premium
24
3,021,541
2,572,925
Treasury share reserve
25,26
(2,590)
(1,862)
Other reserves
26
13
127
Accumulated deficit
(2,471,087)
(1,859,953)
Total equity attributable to owners of the parent
company
602,912
757,573
The accompanying notes are an integral part of these Consolidated Financial Statements.
As of December 31,
(in thousands of SEK)
Note
2022
2021
LIABILITIES
Non
-current liabilities:
Long-term loan
21
762,601
-
Lease liabilities
6
21,326
28,491
Deferred revenue
13
29,500
47,020
Contingent consideration
18
757
722
Provisions
15
5,192
7,357
Deferred tax liabilities
16
405
426
Total non
-current liabilities
819,781
84,016
Current liabilities:
Current tax liabilities
604
-
Lease liabilities
6
7,165
6,888
Trade payables
20
62,476
53,360
Other liabilities
12
18,278
13,548
Deferred revenue
13
40,430
24,961
Refund liabilities
8
27,013
-
Accrued expenses
11
108,747
72,462
Total current liabilities
264,713
171,219
Total liabilities
1,084,495
255,235
TOTAL EQUITY AND LIABILITIES
1,687,406
1,012,808
63
The Group Financial Statements
continued
Consolidated statement of profit or loss and other comprehensive income (loss)
Years Ended December 31,
(in thousands of SEK, except for shares and per share data)
Note
2022
2021
Revenue
13
154,525
33,878
Cost of revenue
(38,477)
(15,425)
Sales, general and administrative expenses
29
(337,861)
(327,269)
Research and development expenses
29
(346,244)
(230,764)
Other operating expenses
28
(20,532)
(7,398)
Loss from operations
(588,588)
(546,978)
Finance income
22
27,248
67
Finance expenses
22
(48,639)
(1,219)
Loss before tax
(609,979)
(548,130)
Income tax expense
16
(1,155)
(152)
Loss for the year
(611,134)
(548,282)
Loss for the year attributable to owners of the parent
(611,134)
(548,282)
Loss per share, basic and diluted (SEK)
17
(13.60)
(12.33)
Weighted-average number of ordinary shares
outstanding, basic, and diluted
44,923,998
44,473,452
The accompanying notes are an integral part of these Consolidated Financial Statements.
Years Ended December 31,
(in
thousands of SEK)
Note
2022
2021
Loss for the year
(611,134)
(548,282)
Other comprehensive income (loss):
Items that are or may be reclassified subsequently to
profit or loss, net of tax:
Exchange differences on translating foreign operations
(114)
264
Other comprehensive income (loss) for the year
(114)
264
Total comprehensive loss for the year
(611,248)
(548,018)
Total comprehensive loss for the year attributable to
owners of the parent
(611,248)
(548,018)
64
The Group Financial Statements
continued
Consolidated statement of cash flow
Years Ended December 31,
(in thousands of SEK)
Note
2022
2021
Cash Flows from Operating Activities
Loss for the year
(611,134)
(548,282)
Adjustments to reconcile net loss to net cash flows:
Depreciation and amortization expenses
12,054
8,606
Capitalized development cost
4
(20,853)
Expenses related to incentive programs
58,226
56,624
Costs related to pension plan
(226)
Accrued interest and unrealized currency differences
34,006
(6)
(527,701)
(483,284)
Changes:
(Increase) decrease of trade receivables & unbilled
revenues
8
(33,247)
(9,602)
Increase of other operating assets
(21,897)
(29,756)
Increase (decrease) trade payables
9,116
28,577
Increase of other operating liabilities
67,460
13,668
Total changes
21,432
2,887
Interest received, (paid), net
5,101
(627)
Income taxes paid
(1,565)
(143)
Net cash used in operating activities
(502,733)
(481,168)
Cash Flows from Investing Activities
Proceeds from sale of short-term investments
232,644
Acquisition of property and equipment
5
(3,331)
(2,399)
Net cash (used in) from investing activities
229,313
(2,399)
The accompanying notes are an integral part of these Consolidated Financial Statements.
Years Ended December 31,
Note
2022
2021
Cash Flows from
Financing Activities
Proceeds from
long-term loan, net of transaction costs
(1)
728,373
Proceeds from issue of ordinary shares, net of
transaction costs
(2)
396,196
Payment of lease liabilities
6,30
(6,888)
(4,857)
Net cash (used in)
from financing activities
1,117,681
(4,857)
Net change in cash and cash equivalents
844,261
(488,424)
Cash and cash equivalents at beginning of year
651,342
1,139,362
Effects of movements in exchange rate on cash held
576
403
Cash and cash equivalents at end of year
1,496,179
651,342
(1)
Total long-term loan transaction cost amounted to SEK 8.027k.
(2)
Total share issue cost amounted to SEK 19,754k.
65
The Group Financial Statements
continued
Consolidated statement of changes in equity
(in thousands of SEK)
Note
Share
Capital
Share
Premium
Treasury
Share
Reserve
Translation
Reserve
Accumulated
deficit
Total equity
attributable to
owners of the parent
company
Balance at January 1, 2021
45,895
2,509,458
(1,421)
(137)
(1,311,671)
1,242,124
Consolidated statement of profit or loss and other
comprehensive income (loss):
Loss for the year
(548,282)
(548,282)
Other comprehensive income for the year
264
264
Total comprehensive loss for the year
264
(548,282)
(548,018)
Issue of Class C shares
(1)
440
(440)
Long term incentive program
63,467
63,467
Balance at December 31, 2021
23,24,25,26
46,335
2,572,925
(1,862)
127
(1,859,953)
757,573
Consolidated statement of profit or loss and other comprehensive
income (loss):
Loss for the year
(611,134)
(611,134)
Other comprehensive loss for the year
(114)
(114)
Total comprehensive loss for the year
(114)
(611,134)
(611,248)
Issue of ordinary shares
(2)
7,848
388,348
396,196
Issue of Class C shares
(3)
851
(851)
Exercise of share rights
(122)
122
Long term incentive program
60,391
60,391
Balance at December 31, 2022
23,24,25,26
55,034
3,021,541
(2,590)
13
(2,471,087)
602,912
(1)
The year 2021 additions of Class C shares refer to the new issue and subsequent repurchase of Class C shares that have taken place in accordance with the respective long term incentive plan (LTIP) program.
(2)
Total share issue cost amounted to SEK 19,754k.
(3)
The year 2022 additions of Class C shares refer to the new issue and subsequent repurchase of Class C shares that have taken place in accordance with the respective long term incentive plan (LTIP) program.
The accompanying notes are an integral part of these Consolidated Financial Statements.
66
Notes to the Group Financial Statements
Note 1
General Information
Hansa Biopharma AB (Hansa, the Company; and together with its subsidiaries, the Group) is a
commercial-stage biopharmaceutical company pioneering the development and
commercialization of innovative, life-saving and life-altering treatments for patients with rare
immunological conditions. The Company has developed a proprietary antibody-cleaving
enzyme technology platform to target pathogenic or disease-causing antibodies. Its broad
therapeutic pipeline has potential applications across transplantation, autoimmune diseases,
gene therapy and oncology indications addressing significant unmet medical needs. Hansa has
received conditional approval of Idefirix (imlifidase) by the European Commission for
desensitization treatment of highly sensitized kidney transplant patients. Hansa is a public
limited liability company under the laws of Sweden, based in Lund, Sweden, and has operations
in Europe and the United States. The Group consists of the parent company, Hansa Biopharma
AB and the subsidiaries Cartela R&D AB, Hansa Biopharma Ltd, Hansa Biopharma Inc. and
Hansa Biopharma Australia PTY LTD.
Note 2
Basis of Presentation and Summary of Significant Accounting Policies
Basis of accounting
The consolidated financial statements are reported in Swedish Krona, Hansa Biopharma AB’s
functional currency, and prepared in accordance with International Financial Reporting
Standards (IFRS), issued by the International Accounting Standards Board (IASB) and the
interpretations issued by the IASB’s International Financial Reporting Interpretation Committee.
The consolidated financial statements provide a general overview of the Group’s activities and
the results achieved. They present fairly the entity’s financial position, its financial performance,
and cash flows, on a going concern basis. The accounting policies described in Note 2 and 3 of
the Group’s consolidated financial statements have been applied in preparing the consolidated
financial statements as of and for the year ended December 31, 2022, and for the comparative
information as of and for the year ended December 31, 2021.The significant accounting policies
applied in the preparation of the above consolidated financial statements are set out below.
The preparation of consolidated financial statements requires management to exercise its
judgment in the process of applying the Group’s accounting policies. The areas involving a
higher degree of judgment or complexity, or areas where assumptions and estimates that are
significant to the consolidated financial statements are disclosed in Note 3.
These consolidated financial statements of the Group as of December 31, 2022, and for the
year then ended were approved by the Board of Directors of the Group and authorized for issue
on March 30, 2023.
Changes in Accounting Policies and Disclosures
Several amendments to and interpretations of IFRS applied for the first time in 2022, which has
not had an impact on the accounting policies applied by the Group. Thus, the accounting
policies applied when preparing these consolidated financial statements have been applied
consistently to all the periods presented, unless otherwise stated.
Basis of Consolidation
The consolidated financial statements include Hansa Biopharma AB, Lund Sweden, and
subsidiaries over which the Group has control. Control is achieved when the Group:
>
has power over the investee;
>
is exposed, or has rights, to variable returns from its involvement with the investee; and
>
has the ability to use its power to affect its returns.
The Group reassesses whether it controls an investee if facts and circumstances indicate that
there are changes to one or more of the three elements of control listed above. If the Group
does not have a majority of the voting rights of an investee, it has power over the investee when
the voting rights are sufficient to give it the practical ability to direct the relevant activities of the
investee unilaterally.
The Group considers all relevant facts and circumstances in assessing whether the Group’s
voting rights in an investee are sufficient to give it power, including:
>
the size of the Group’s holding of voting rights relative to the size and dispersion of holdings
of the other vote holders;
>
potential voting rights held by the Group;
>
rights arising from other contractual arrangements; and
>
any additional facts and circumstances that indicate that the Group has, or does not have, the
current ability to direct the relevant activities at the time that decisions need to be made,
including voting patterns at previous shareholders’ meetings.
Consolidation of a subsidiary begins when the Group obtains control over the subsidiary and
ceases when the Group loses control of the subsidiary. Specifically, income and expenses of a
subsidiary acquired or disposed of during the year are included in the consolidated statement of
profit or loss and other comprehensive income (loss) from the date the Group gains control until
the date when the Group ceases to control the subsidiary.
Adjustments are made to the financial statements of subsidiaries to bring their accounting
policies in line with the Group’s accounting policies. All intra group transactions, balances,
income and expenses are eliminated in full in consolidation. Unrealized losses are also
eliminated unless the transaction provides evidence of an impairment of the transferred asset.
67
Notes to the Group Financial Statements continued
The Group holds investments either directly or indirectly in the following subsidiaries:
Share ownership percentage (%)
Subsidiaries
Registered
office/Country
2022
2021
Cartela R&D AB
Lund, Sweden
100
100
Hansa Biopharma Ltd
Cheltenham,
UK
100
100
Hansa Biopharma Inc
Delaware,
USA
100
100
*Hansa Biopharma Australia Pty Ltd
Australia
100
100
*Dormant company
Because the functional currency for Hansa Biopharma Ltd and Hansa Biopharma Inc is the UK
Pound Sterling and the United States Dollar, respectively, the Group has foreign currency
exposure. See “Functional and Presentation Currency” section that follows and Note 20,
“Financial Risk and Financial Instruments.”
Functional and Presentation Currency
The presentation currency of the consolidated financial statements is Swedish Kronor (SEK).
The functional currency, which is the currency that best reflects the economic environment in
which the subsidiaries of the Group operate and conduct their transactions, is separately
determined for the Group’s subsidiaries and is used to measure their financial position and
operating results.
Transactions in currencies other than the functional currency of a subsidiary are recorded at the
rates of exchange prevailing at the date of the transaction. Monetary assets and liabilities in
currencies other than the functional currency are remeasured at the rates of exchange
prevailing on the date of the consolidated statements of financial position and the related
translation gains and losses are recognized in the Consolidated statement of profit or loss and
other comprehensive income. Non-monetary items that are carried at cost are translated using
the rate of exchange prevailing at the date of the transaction. Non-monetary items that are
carried at fair value are translated using the exchange rate prevailing when the fair value was
determined, and the related translation gains and losses are reported in the Consolidated
statement of profit or loss and other comprehensive income.
Upon consolidation, the results of operations of subsidiaries whose functional currency is other
than the SEK are translated into SEK at the monthly average exchange rates and assets and
liabilities are translated at the year-end exchange rates. Translation adjustments are recognized
directly in other comprehensive income.
Measurement of Fair Values
The Group’s accounting policies and disclosures require the measurement of fair values, for
both financial and non-financial assets and liabilities. The Group has an established control
framework with respect to the measurement of fair values. This includes the use of valuation
specialists that have responsibility for overseeing certain significant fair value measurements,
including Level 3 fair values, and reports directly to the chief financial officer. If third party
information, such as broker quotes or pricing services, is used to measure fair values, then the
Group assesses the evidence obtained from the valuation specialists to support the conclusion
that these valuations meet the requirements of the Standards, including the level in the fair
value hierarchy in which the valuations should be classified. Significant valuation issues are
reported to the Group’s audit committee.
When measuring the fair value of an asset or a liability, the Group uses observable market data
as far as possible. Fair values are categorized into different levels in a fair value hierarchy
based on the inputs used in the valuation techniques as follows:
>
Level 1: quoted prices (unadjusted) in active markets for identical assets or liabilities.
>
Level 2: inputs other than quoted prices included in Level 1 that are observable for the asset
or liability, either directly (i.e., as prices) or indirectly (i.e., derived from prices).
>
Level 3: inputs for the asset or liability that are not based on observable market data
(unobservable inputs).
If the inputs used to measure the fair value of an asset or a liability fall into different levels of the
fair value hierarchy, then the fair value measurement is categorized in its entirety in the same
level of the fair value hierarchy as the lowest level input that is significant to the entire
measurement. The Group recognizes transfers between levels of the fair value hierarchy at the
end of the reporting period during which the change has occurred.
Revenue
Revenue is recognized when control of the promised goods or services is transferred to the
customer, and in an amount that reflects the consideration the Group received or expects to
receive in exchange for those goods or services.
The Group derives its revenues primarily from products and contractual arrangements. The
Group determines revenue recognition through the following steps:
>
(1) Identification of the contract, or contracts, with a customer.
>
(2) Identification of the performance obligation(s) in the contract.
>
(3) Determination of the transaction price.
>
(4) Allocation of the transaction price to the performance obligations in the contract.
>
(5) Recognition of revenue when, or as, the Group satisfies a performance obligation.
68
Notes to the Group Financial Statements continued
Product revenue
Product revenue is recognized net of any sales and value added taxes and sales deductions
based on contractually agreed payment terms. The control passes according to contractual
terms. The amount of consideration the Group receives and revenue the Group recognizes
varies based on actual or estimated rebates, discounts, returns and charge backs. The Group
adjusts its estimate of revenue at the earlier of when the most likely amount of consideration the
Group expects to receive changes or when the consideration becomes fixed.
Sales returns are generally estimated and recorded based on historical sales and returns
information. Sales returns allowances represent a reserve for products that may be returned
due to expiration, damage or potential other reasons typically calculated as a percent of gross
revenues. For the periods ended December 31, 2022, and 2021, there have been no sales
returns.
Contract revenue
The Group accounts for a contract when it has approval and commitment from both parties, the
rights of the parties are identified, payment terms are identified, the contract has commercial
substance and collectability of consideration is probable.
In determining the proper revenue recognition method, the performance obligation(s) under an
agreement is reviewed and evaluated if such obligation(s) be accounted for as more than one
performance obligation.
For certain contracts, a service of combining a license and related tasks into a single
performance obligation may be provided. In such a case, the entire contract is accounted for as
one performance obligation. Certain contracts may promise to provide a distinct license with
distinct services within a contract, in which case the contract is separated into more than one
performance obligation. If a contract is separated into more than one performance obligation,
the total transaction price is allocated to each performance obligation in an amount based on
the estimated relative standalone selling price of the promised goods or services underlying
each performance obligation. Non-refundable upfront payments and substantive development
and sales milestone payments are typically recognized over the remaining performance period
based on the progress towards satisfying its identified performance obligation.
Grant revenue
Because the Group carries out extensive research and development activities, the Group may
benefit from various grants, research and development incentives and payroll tax rebates from
certain governmental agencies. These grants, research and development incentives and payroll
tax rebates generally aim to partly reimburse approved expenditures incurred in research and
development efforts of the Group and are credited to the consolidated statement of profit or loss
and other comprehensive income, under the line other operating income, when the relevant
expenditure has been incurred and there is reasonable assurance that the grants or research
and development incentives are receivable.
Research and Development Expenses
Research cost are expensed as incurred. Development cost are typically expensed as incurred,
unless capitalized. Costs of research and development equipment with alternative future uses
are capitalized and depreciated over the equipment’s useful life.
Research and development expenses primarily include costs for third-party services in
connection with clinical studies and research projects, costs for producing substance to be used
in such studies and projects, personnel expenses for the Group’s research and development
groups, and depreciation of equipment used for research and development activities. In
addition, research and development expenses contain expenses for producing pharmaceutical
material which may be used for commercialization subject to regulatory approval, and which
was produced prior to obtaining regulatory approval or evidence being available that regulatory
approval can reasonably be expected.
Expenditures on research activities are recognized in the consolidated statement of profit or
loss and other comprehensive income (loss) as incurred. Development expenditures are
capitalized only if the expenditure can be measured reliably, the product or process is
technically and commercially feasible, future economic benefits are probable, and the Group
intends to and has sufficient resources to complete development and to use or sell the asset.
Otherwise, it is recognized in the consolidated statement of profit or loss and other
comprehensive income (loss) as incurred. Subsequent to initial recognition, development
expenditure is measured at cost less accumulated amortization and any accumulated
impairment losses.
Generally, expenditures are not capitalized before the pharmaceutical authorities have given
approval due to the level of uncertainty associated with the approval process. In 2022, Hansa
started to capitalize certain development cost related to fulfilment of the EMA post-approval
commitments related to its conditional approval of imlifidase in the EU as it met all requirements
under IAS 38. Please refer to Note 4 for further information.
Sales, General and Administrative Expenses
Sales, general and administrative expenses consist primarily of (i) personnel expenses relating
to salaries and related costs for personnel, including share-based compensation, of our
employees in executive, commercial, finance, business development and support functions, (ii)
fees relating to professional services for commercialization, marketing, selling, medical affairs,
corporate management, legal, finance, human resources, business development, licensing and
investor relations, (iii) board expenses consisting of directors’ fees and travel expenses for
board members, and (iv) other general and administrative expenses, including leasing costs,
office expenses and travel costs. General and administrative expenses are recognized in the
consolidated statement of profit or loss and other comprehensive income (loss) in the period to
which they relate.
69
Notes to the Group Financial Statements continued
Pensions
Plans where the Group’s obligations are limited to the contribution the Group has undertaken to
pay are classified as “defined contribution pension plans”. In such cases, the size of the
employee’s pension is dependent upon the contribution which the Group pays into the plan, or
to an insurance company, and the return on capital which the contribution generates.
Consequently, it is the employee who bears the actuarial risk (that the benefits will be lower
than anticipated) and the investment risk (that the invested assets will be insufficient to generate
the anticipated benefits). The Group’s obligations regarding fees paid to defined contribution
plans are reported as an expense in the consolidated statement of profit or loss and other
comprehensive income (loss) when they are earned by the employees performing their services
on behalf of the Group during a given period of time.
Employee Benefits
Short-term employee benefits
Short-term employee benefits are expensed as the related service is provided. A liability is
recognized for the amount expected to be paid if the Group has a present legal or constructive
obligation to pay this amount as a result of past service provided by the employee and the
obligation can be estimated reliably.
Long-term employee benefits
The Group’s net obligation in respect of long-term employee benefits is the amount of future
benefit that employees have earned in return for their service in the current and prior periods.
That benefit is discounted to determine its present value. Remeasurements are recognized in
profit or loss in the period in which they arise.
Termination benefits
Termination benefits are expensed at the earlier of when the Group can no longer withdraw the
offer of those benefits and when the Group recognizes costs for a restructuring. If benefits are
not expected to be settled wholly within 12 months of the reporting date, then they are
discounted.
Share-based Payments
The Company has provided share-based payment awards through long-term incentive
programs for certain employees whereby participants are provided ordinary shares of the
Company after the vesting period, either through share rights or employee stock options, if
certain performance conditions are met. Vesting is based on market or non-market performance
conditions. For awards that vest upon achieving a market condition, the Company’s share price
must achieve certain thresholds. For awards that vest upon achieving non-market conditions,
the Company must achieve certain pre-defined business objectives related to financial, portfolio
and/or commercial targets.
The awards are classified as equity-settled share-based payments since the only settlement
alternative is in shares of the Company. For equity-settled programs, the fair value of the
instruments is determined at the grant date and is subsequently not remeasured. The share-
based payment expense is recognized over the vesting period with a corresponding entry
recognized directly in equity. Social security costs relating to share- based compensation are
recognized as expense in profit or loss over the same vesting period, based on the fair value of
the equity instruments at each reporting date. An amount corresponding to the recognized
expense is recognized as a liability.
The fair value of the options is calculated based on the Black-Scholes model and expensed
over the vesting period. During the vesting period, the expense is adjusted in order to account
for the number of options that are expected to vest.
For share rights that vest upon achieving market conditions, the Company determines the value
of the awards using the Monte Carlo model at the grant date because different share price
realizations result in different values for the award. The effect of a market condition is reflected
in the grant-date fair value of an award. The share-based payment expense is recognized over
the three-year vesting period provided that the service is rendered, regardless of when, if ever,
the market condition is satisfied.
For share rights with a non-market performance condition, the Company valued the awards
using Black-Scholes model. The exercise price of the share rights has been set using a volume
weighted average of the Company’s share price over a certain period before grant date. For the
estimation of expected future volatility, the average 90-day historical volatility was estimated for
the Company and, as a benchmark, for several peers over periods between one and seven
years. The yield curve for Swedish government bonds is used to determine the risk-free interest
rate. After the value of the awards were determined, the Company estimated the probability of
achieving the non-market conditions and adjusted the number of awards that would expense
over the amortization period. The Company re-evaluates the probability of achieving the non-
market conditions each reporting period.
Other operating income and expenses
Other income
Other income includes foreign currency gain on receivables from operating activities and gain
from disposal of assets.
Other expenses
Other expenses include foreign currency loss on receivables from operating activities and loss
from disposals of assets.
Finance Income and Expenses
Finance income and expenses comprise of interest income and expenses, amortization of
securities, and realized and unrealized exchange rate gains and losses on transactions
denominated in foreign currencies.
70
Notes to the Group Financial Statements continued
Interest income or expense is recognized using the effective interest method.
The effective
interest rate is the rate that exactly discounts estimated future cash payments or receipts
through the expected life of the financial instrument to the gross carrying amount of the financial
asset; or the amortized cost of the financial liability.
In calculating interest income and expense,
the effective interest rate is applied to the gross carrying amount of the asset (when the asset is
not credit-impaired) or to the amortized cost of the liability.
However, for financial assets that
have become credit-impaired subsequent to initial recognition, interest income is calculated by
applying the effective interest rate to the amortized cost of the financial asset.
If the asset is no
longer credit-impaired, then the calculation of interest income reverts to the gross basis.
Income Taxes
Tax for the year, which consists of current tax for the year and changes in deferred tax, is
recognized in the Consolidated statement of profit or loss and other comprehensive income
(loss) by the portion attributable to the profit or loss for the year and recognized directly in equity
or other comprehensive income by the portion attributable to entries directly in equity and in
other comprehensive income. The current tax payable or receivable is recognized in the
consolidated statement of financial position, stated as tax computed on this year’s taxable
income, adjusted for prepaid tax.
When computing the current tax for the year, the tax rates and tax rules enacted or substantially
enacted at the reporting date are used. Current tax payable is based on taxable profit or loss for
the year. Taxable profit or loss differs from net profit or loss as reported in the consolidated
statement of profit or loss and other comprehensive income (loss) because it excludes items of
income or expense that are taxable or deductible in prior or future years. In addition, taxable
profit or loss excludes items that are never taxable or deductible.
Deferred tax is recognized according to the balance sheet liability method of all temporary
differences between carrying amounts and tax-based values of assets and liabilities, apart from
deferred tax on all temporary differences occurring on initial recognition of goodwill or on initial
recognition of a transaction which is not a business combination, and for which the temporary
difference found at the time of initial recognition neither affects profit or loss nor taxable income.
Deferred tax liabilities are recognized on all temporary differences related to investments in
subsidiaries and/or associates, unless the Group is able to control when the deferred tax is
realized, and it is probable that the deferred tax will not become due and payable as current tax
in the foreseeable future.
Deferred tax assets, including the tax base of tax loss carry forwards, are recognized in the
statement of financial position at their estimated realizable value, either as a set-off against
deferred tax liabilities or as net tax assets for offset against future positive taxable income.
Deferred tax assets are only offset against deferred tax liabilities if the entity has a legally
enforceable right to set off, and the deferred tax assets and deferred tax liabilities relate to
income taxes levied by the same tax jurisdiction. Deferred tax is calculated based on the
planned use of each asset and the settlement of each liability, respectively.
Deferred tax is measured using the tax rates and tax rules in the relevant countries that, based
on acts in force or acts in reality in force at the reporting date are expected to apply when the
deferred tax is expected to crystallize as current tax. Changes in deferred tax resulting from
changed tax rates or tax rules are recognized in the consolidated statement of profit or loss and
other comprehensive income (loss) unless the deferred tax is attributable to transactions
previously recognized directly in equity or other comprehensive income. In the latter case, such
changes are also recognized in equity or other comprehensive income. On every reporting date,
it is assessed whether sufficient taxable income is likely to arise in the future for the deferred tax
asset to be utilized.
Property and Equipment
Property and equipment are measured at cost less accumulated depreciation and any
accumulated impairment losses. Cost comprises the acquisition price, costs directly attributable
to the acquisition and preparation costs of the asset until the time when it is ready to be used in
operation. Subsequent costs are included in the carrying amount of the asset or recognized as
a separate asset, as appropriate, only when it is probable that future economic benefits
associated with the assets will flow to the Group and the costs of the items can be measured
reliably. All repair and maintenance costs are charged to the consolidated statement of profit or
loss and other comprehensive income (loss) during the financial periods in which they are
incurred.
Equipment acquired for research and development activities with alternative use, which is
expected to be used for more than one year, is capitalized and depreciated over the estimated
useful life as research and development costs. Equipment acquired for research and
development activities, which has no alternative use, is recognized as research and
development costs when incurred.
If the acquisition or use of the asset involves an obligation to incur costs of decommissioning or
restoration of the asset, the estimated related costs are recognized as a provision and as part of
the relevant asset’s cost, respectively.
71
Notes to the Group Financial Statements continued
The basis for depreciation is cost less estimated residual value. The residual value of an asset
is the estimated amount that an entity would currently obtain from disposal of the asset, after
deducting the estimated costs of disposal, if the asset were already of the age and in the
condition expected at the end of its useful life. If significant parts of an item of property and
equipment have different useful lives, then they are accounted for as separate items (major
components) of property and equipment. Depreciation commences when the asset is available
for use, which is when it is in the location and condition necessary for it to be capable of
operating in the manner intended.
Depreciation is calculated on a straight-line basis, based on an asset’s expected useful life,
being within the following ranges:
Property and equipment
3
10 years
Right-of-use assets
3
4 years
Depreciation methods, useful lives and residual values are reviewed at each reporting date and
adjusted if appropriate.
Depreciation and impairment losses of property and equipment is recognized in the
Consolidated statement of profit or loss and other comprehensive income (loss) as research
and development costs or as selling, general and administrative expenses, as appropriate.
Gains and losses on disposal of property and equipment are recognized in the Consolidated
statement of profit or loss and other comprehensive income (loss) at its net proceeds, as either
other income or other expenses, as appropriate.
Intangible Assets
Internally generated intangible assets
Development expenditure is capitalized only if all respective requirements under IAS 38 are fully
met, particularly, the expenditure can be measured reliably, the product or process is technically
and commercially feasible, future economic benefits are probable and the Group intends to and
has sufficient resources to complete the development and to use or sell the asset.
Otherwise, it
is recognized in profit or loss as incurred.
Subsequent to initial recognition, capitalized
development expenditure is measured at cost less accumulated amortization and any
accumulated impairment losses.
Subsequent expenditure is capitalized only when it increases the future economic benefits
embodied in the specific asset to which it relates.
All other expenditure, including expenditure
on internally generated goodwill and brands, is recognized in profit or loss as incurred.
In 2022, Hansa started to capitalize certain development cost related to fulfilment of the EMA
post-approval commitments related to its conditional approval of imlifidase in the EU as it met all
requirements under IAS 38. Please refer to Note 4 for further information.
Amortization is calculated to write off the cost of intangible assets less their estimated residual
value using the straight-line method over their estimated useful life and is generally recognized
in consolidated statement of profit or loss and other comprehensive income (loss).
The estimated useful lives for current and comparative periods are as follows:
Development costs
:
10 years
Amortization methods, useful lives and residual values are reviewed at each reporting date and
adjusted if appropriate.
Acquired intangible assets
Acquired intangible assets held by the Group consists of patents and in-process development
projects acquired in a business combination. The intangible assets were originally recognized at
the acquisition date fair value. Subsequently, they are measured at cost less accumulated
amortization and any impairment. Amortization is calculated to write off the cost of development
projects, less their estimated residual values, using the straight- line method over their
estimated useful lives and commence when the projects start to generate revenue, being within
the following range:
Patents
:
Until expiry date
In
-process development projects:
10
15 years
Impairment
If circumstances or changes in the Group’s operations indicate that the carrying amount of non-
current assets in a cash-generating unit may not be recoverable, management reviews the
asset for impairment. An annual impairment test is also performed for assets yet to be brought
into use, i.e. per December 31, 2022 in-process development projects and capitalized
development cost relating to imlifidase. The basis for the review is the recoverable amount of
the assets, determined as the greater of the fair value less costs of disposal or its value in use.
Such review uses an analysis of current market value (market cap of the Company) as the fair
value less cost of disposal. If the carrying amount of an asset is greater than the recoverable
amount, the asset is written down to the recoverable amount. An impairment loss is recognized
in the consolidated statement of profit or loss and other comprehensive income (loss) when the
impairment is identified. The Group assesses at the end of each reporting period whether there
is any indication that an asset may be impaired. If any such indication exists, the Group will
estimate the recoverable amount of the asset.
72
Notes to the Group Financial Statements continued
Inventories
Inventories are assets:
(a) held for sale in the ordinary course of business;
(b) in the process of production for such sale; or
(c) in the form of materials or supplies to be consumed in the production process or in the
rendering of services.
Costs related to the manufacturing of inventories which occurred after the receipt of regulatory
approval for the respective product are capitalized, otherwise, they are expensed as research
and development expenses when incurred.
The cost of inventories includes all costs of purchase, costs of conversion and other costs
incurred in bringing the inventories to their present location and condition. Inventories are
valued at the lower of cost and net realizable value. Cost is determined based on the first-in
first-out (“FIFO”) costing method. The Company regularly reviews the net realizable value and
adjusts the carrying inventory amounts for any excess, obsolete or slow-moving inventory.
Unbilled revenues & refund liabilities
Unbilled revenues primarily relate to the Group’s right to consider product sold but not billed at
the reporting date. The unbilled revenues are transferred to trade receivables when the rights
become unconditional. This usually occurs when the Group issues an invoice to the customer.
Refund liabilities primarily relate to the Group’s actual or estimated rebates, discounts, return
and charge back obligations.
The refund liabilities are transferred to trade payables when the
obligation becomes unconditional.
This usually occurs when the Group receives an invoice
from third party, typically the healthcare sponsor in the country where the sale occurred.
Trade receivables
Trade receivables are recorded at net realizable value after consideration of an allowance for
expected credit losses. The Company generally maintains allowances for estimated
uncollectible receivables based on historical experience and, where such historical experience
does not exist, on country-specific default rates. The adequacy of the allowance is evaluated on
an ongoing and periodic basis and adjustments are made in the period in which a change in
condition occurs.
Please refer to section “Financial instruments” below for further information.
Cash and Cash Equivalents
Cash and cash equivalents comprise of on-demand deposits with financial institutions. Cash
and cash equivalents are measured at amortized cost.
Shareholders’ Equity
The share premium reserve is comprised of the amount received, attributable to shareholders’
equity, in excess of the nominal amount of the shares issued, reduced by any amount allocated
external expenses directly attributable to the offerings. The share premium reserve can be
distributed.
Shareholders are entitled to dividends which are determined after they become shareholders.
Shareholdings entitle a shareholder to one vote per share at general meetings.
The year 2022 additions of Class C shares refer to the new issue and subsequent repurchase
of Class C shares related to the funding of the long-term incentive plan (LTIP) 2022, as
approved by the 2022 AGM.
The treasury shares reserves comprise own shares repurchased by the Group.
The translation reserve comprises all foreign exchange differences arising on translation of
financial statements from foreign business prepared in currency other than the reporting
currency for the financial statements of the Group.
Retained earnings/accumulated deficit, including profit/loss for the year, includes profits
earned/losses incurred by the Group and its subsidiaries. Previous allocations to statutory
reserves, excluding transferred share premium reserves, are included in this shareholders’
equity item.
No dividend was paid for the periods ended December 31, 2022, or 2021.
Leases
The Group leases various offices, laboratory facilities, equipment and vehicles. Rental contracts
are typically made for fixed periods of three to four years, but certain contracts may have
extension options.
Contracts may contain both lease and non-lease components. The Group allocates the
consideration in the contract to the lease and non-lease components based on their relative
stand-alone prices. For leases of real estate, it has elected not to separate lease and non-lease
components and instead accounts for these as a single lease component. Lease terms are
negotiated on an individual basis and contain a wide range of different terms and conditions.
The lease agreements do not impose any covenants other than the security interests in the
leased assets that are held by the lessor. Leases are recognized as right-of-use assets and
corresponding liabilities at the date at which the underlying assets are available for use by the
Group. Leased assets and lease liabilities arising from a lease are initially measured at present
value. Lease liabilities include the net present value of the lease payments, and they are
discounted using the lessee’s incremental borrowing rate.
73
Notes to the Group Financial Statements continued
Subsequent to initial recognition, the right-of-use is measured at amortized cost using the
effective interest method.
Leased assets are generally depreciated over the shorter of the asset’s useful life and the lease
term on a straight-line basis. If the Group is reasonably certain to exercise a purchase option,
the right-of-use assets are depreciated over the underlying asset’s useful life. Payments
associated with short-term leases of equipment and all leases of low-value assets are
recognized on a straight-line basis as an expense in the consolidated statement of profit or loss
and other comprehensive income. Short-term leases are leases with a lease term of twelve
months or less. Low-value assets comprise mainly of IT equipment and small items of office
furniture.
Extension and termination options are included in a number of property and equipment leases
across the Group. These are used to maximize operational flexibility in terms of managing the
assets used in the Group’s operations.
Trade Payables
Trade payables are measured in the consolidated statement of financial position at amortized
cost.
Other Liabilities
Other liabilities comprise payables to public authorities, and short-term employee benefits.
Other liabilities are measured at their either amortized cost or historical cost which is reasonable
approximation of their fair value.
Financial Instruments
Financial instruments which are recognized in the consolidated statement of financial position
include, on the assets side, cash and equivalents, short term investments, other receivables,
trade receivables and listed shares. On the liability side, long-term loan, trade payables and
contingent consideration.
Trade receivables are initially recognized when they are originated. Regular-way purchases and
sales of financial assets are recognized on the settlement date. Other financial assets and
financial liabilities are recognized when the Group becomes party to the instrument’s contractual
terms.
Financial instruments are initially recognized at fair value with the addition/deduction for
transaction expenses, except for instruments that are continuously measured at fair value
through the consolidated statement of profit or loss and other comprehensive income (loss) for
which transaction expenses are instead expensed when they arise. Trade receivables (without
a significant financing component) are initially valued at the transaction price as determined in
accordance with IFRS 15.
On initial recognition, a financial asset is classified as measured at: amortized cost, fair value
through other comprehensive income (debt instrument investment), fair value through other
comprehensive income (equity investment), or fair value through the consolidated statement of
profit or loss and other comprehensive income (loss).
Holdings of units in interest funds are reported at fair value through the consolidated statement
of profit or loss and other comprehensive income (loss). The shares (seen from the fund’s
perspective) constitute financial liabilities and as such do not give rise to solely payments of
principal and interest and do therefore not fulfil the amortized cost requirements.
Other financial assets that are held within the framework of a business model with a goal to
obtain the contractual cash flows at the same time as the cash flows from the assets and
consist solely of payments of principal and interest (SPPI) are recognized at amortized cost.
Financial liabilities are classified as valued at amortized cost or valued at fair value through the
consolidated statement of profit or loss and other comprehensive income (loss). Financial
liabilities that are measured at fair value through the consolidated statement of profit or loss and
other comprehensive income (loss) consist of contingent consideration, not yet paid. Other
financial liabilities are valued at amortized cost.
Financial assets are derecognized when the rights to receive cash flows from the financial
assets have expired or have been transferred and the Group has transferred substantially all
the risks and rewards of ownership.
The Group derecognizes a financial liability from the consolidated statement of financial position
when, and only when, it is extinguished. That is, when the obligations specified in the contract is
either discharged or cancelled or has expired. The Group also removes a financial liability from
the statement of financial position when the contractual terms are modified and the cash flows
from the modified debt are significantly different. In that case, a new financial liability is reported
at fair value based on the modified terms.
Impairment of financial assets
For financial assets valued at amortized cost, a reserve must be booked for expected credit
losses according to IFRS 9. The loss reserve for trade receivable is valued at an amount
corresponding to the expected losses for the remaining term. In addition, the loss reserve for
deposits in banks is insignificant since the Group’s deposits are held with Swedish banks with
good credit rating and the deposits may be withdrawn upon request.
74
Notes to the Group Financial Statements continued
Statement of Cash Flow
The cash flow statement is presented using the indirect method with basis in the net result.
Cash flow from operating activities is stated as the net result adjusted for net financial items,
non-cash operating items such as depreciation, amortization, impairment losses, share-based
compensation expenses, provisions, and for changes in working capital, interest paid and
received, and corporate taxes paid. Working capital mainly comprises changes in receivables,
deferred revenue, provisions paid and other payables excluding the items included in cash and
cash equivalents. Changes in non-current assets and liabilities are included in working capital, if
related to the main revenue-producing activities of the Group.
Cash flow from investing activities is comprised of cash flow from the purchase and sale of
intangible assets and property and equipment and financial assets as well as purchase and sale
of marketable securities.
Cash flow from financing activities is comprised of cash flow from the issuance of shares, if any,
and payment of long-term loans including instalments on lease liabilities.
Cash and cash equivalents, consist of bank deposits. The cash flow statement cannot be
derived solely from the financial statements.
Segment Reporting
The Group is managed and operated as one operating and reportable segment. No separate
operating segments or reportable segments have been identified in relation to product
candidates or geographical markets. Accordingly, except for entity wide disclosures, no
segment information on business segments or geographical markets is disclosed.
Earnings per Share
Basic Earnings per Share (EPS) is calculated by dividing profit or loss attributable to ordinary
equity holders of the parent entity by the weighted average number of ordinary shares
outstanding during the period. Diluted earnings per share is calculated as profit or loss
attributable to ordinary equity holders of the parent entity divided by the weighted average
number of ordinary shares outstanding during the period, both adjusted for the effects of all
dilutive potential ordinary shares. If the result is a net loss, no adjustment is made for the
dilutive effect, as such effect would be anti-dilutive.
Treasury Shares
The treasury shares reserves comprise own shares repurchased by the Group. The total
amount paid to acquire treasury shares including directly attributable costs and the proceeds
from the sale of treasury shares are recognized in treasury share reserve.
New Accounting Policies and Disclosures effective 2022
In the year ended December 31, 2022, the Group has applied the below amendments to IFRS
and interpretations issued by the Board, as applicable. Their adoption has not had any material
impact on the disclosure or on the amounts reported in these consolidated financial statements.
Amendments to IFRS 3 Business Combinations
Amendments to IFRS 3 to update the references to the Conceptual Framework for Financial
Reporting. The amendment also adds an exception for the recognition of liabilities and
contingent liabilities within the scope of IAS 37 Provisions, Contingent liabilities and Contingent
Assets and Interpretation 21 Levies. The amendments also confirm that contingent assets
should not be recognized at the acquisition date. The amendments are effective for periods
beginning on January 1, 2022.
Amendment to IAS 37 Provisions, Contingent Liabilities and Contingent Assets
The amendment to IAS 37 clarifies that the direct costs of fulfilling a contract include both the
incremental costs of fulfilling the contract and an allocation of other costs directly related to
fulfilling contracts. The amendment is effective for periods beginning on January 1, 2022.
Amendments to IAS 16 Property, Plant and Equipment
The amendment to IAS 16 prohibits an entity from deducting from the cost of an item of
property, plant and equipment any proceeds received from selling items produced while the
entity is preparing the asset for its intended use. The amendment is effective for periods
beginning on January 1, 2022.
Standards, amendments, and interpretations in issue
The adoption of the following mentioned standards, amendments and interpretations in future
years are not expected to have a material impact on the Group’s financial statements:
Effective date periods beginning on or after
IAS 1
Presentation of Financial Statements:
Amendments in
relation to the classification of liabilities as current or non
-
current
January 1, 2024
Disclosure of Accounting Policies (Amendments to IAS 1 and
IFRS Practice Statement 2).
January 1, 2023
Def
erred Tax related to Assets and Liabilities arising from a
Single Transaction (Amendments to IAS 12)
January 1, 2023
Definition of Accounting Estimates (Amendments to IAS 8)
January 1, 2023
The Group has not elected to early adopt any of the above standards, amendments and
interpretations in the years ended December 31, 2022, and 2021. The Group plans to adopt
these standards on the effective dates.
75
Notes to the Group Financial Statements continued
Note 3
Use of judgements and estimates
In the application of the Group’s accounting policies, management is required to make
judgements, estimates and assumptions about the carrying amounts of assets and liabilities that
are not readily apparent from other sources. Judgements and estimates applied are based on
historical experience and other factors that are relevant, and which are available at the reporting
date. Uncertainty concerning judgements and estimates could result in outcomes, that require a
material adjustment to assets and liabilities in future periods.
Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to
accounting estimates are recognized in the period in which the estimate is revised if the revision
affects only that period, or in the period of the revision and future periods if the revision affects
both current and future periods. While the application of critical accounting estimates is subject
to material estimation uncertainties, management’s ongoing revisions of critical accounting
estimates have not revealed any material impact in any of the years ended December 31, 2022,
and 2021.
Significant judgements made in the application of the Group’s accounting policies
Significant judgements that management has made in the process of applying the Group’s
accounting principles are described below.
Revenue
Revenue is primarily generated from product sales and license agreements, which typically
involve multiple promises, and thus require significant judgements by the Group on certain
areas including:
>
Determining whether the promises in the agreements are distinct performance obligations;
>
Identifying and constraining variable consideration in the transaction price including milestone
payments;
>
Allocating transaction price to identified performance obligations based on their relative stand-
alone selling prices;
>
Determining whether performance obligations are satisfied over time, or at a point in time; and
>
Classification of licenses as “Right-to-Use” or “Right-to-Access”.
Regarding the classification of licenses as “Right-to-Use” or “Right-to-Access”, the Group
considers whether it is obligated or expected to perform research and development activities
that significantly affect the licensee’s ability to benefit from product candidates. If the Group is
contractually obligated or is expected to perform research and development activities affecting
the stand-alone functionality of the product candidate, the license is classified as “right-to-
access”. The licensed products have been considered “rights-to-access” since the Group is
required to perform activities that significantly affect the licensee’s ability to benefit from the
products.
Share-Based Payment
IFRS 2, “Share-Based Payment” requires an entity to reflect in its consolidated statement of
profit or loss and other comprehensive income (loss) and consolidated statement of financial
position, the effects of share-based payment transactions. Share-based compensation costs are
recognized as research and development expenses or selling, general and administrative
expenses, as appropriate, over the vesting period, based on management’s best estimate of the
number of awards that will ultimately vest, which is subject to uncertainty. In addition, share-
based compensation costs are measured according to the grant date fair values of the
instruments granted. Estimating fair values requires the Group to apply generally accepted
valuation models and apply these models consistently according to the terms and conditions of
the specific share-based compensation programs. Depending on the instrument, the Group
applies the Black Scholes or the Monte Carlo model to determine the fair value of the awards
granted. Subjective judgements and assumptions, which are subject to estimation uncertainties,
need to be exercised in determining the appropriate input to the valuation model.
Note 4
Intangible Assets
Internally generated intangible assets
Expenditure on research activities is recognized as an expense in the period in which it is incurred.
An internally
generated intangible asset arising from development (or from the development
phase of an internal project) is recognized if, and only if, all of the following have been
demonstrated in accordance with IAS 38:
>
the technical feasibility of completing the intangible asset so that it will be available for use or
sale;
>
the intention to complete the intangible asset and use or sell it;
>
the ability to use or sell the intangible asset;
>
how the intangible asset will generate probable future economic benefits;
>
the availability of adequate technical, financial and other resources to complete the
development and to use or sell the intangible asset;
>
and the ability to measure reliably the expenditure attributable to the intangible asset during
its development.
The amount initially recognized for internally
generated intangible assets is the sum of the
expenditure incurred from the date when the intangible asset first meets ALL the recognition
criteria listed above. Where no internally
generated intangible asset can be recognized,
development expenditures are recognized in the statement of profit and loss and other
comprehensive income in the period in which they are incurred.
The Company assessed that with respect to Idefirix
®
(imlifidase) and its conditional approval by
EMA in enabling kidney transplantation in highly sensitized patients it does meet all the above
criteria as of Q4-2022. Going forward, the Company will on a quarterly basis re-assess whether
or not it continues to meet all above criteria and continue to capitalize respective cost for as
long as all criteria are met.
76
Notes to the Group Financial Statements continued
For the year ending December 31, 2022 the Company capitalized development cost in the
amount of SEK 20.9 million related to performing its Idefirix
®
(imlifidase) EMA post-approval
commitments. Capitalized development cost mainly include fees paid to 3
rd
party service
providers, personnel expenses of Hansa staff and approportionate finance cost.
Due to uncertainties inherent to the development and registration with the relevant healthcare
authorities of imlifidase in any other indications, the Company estimates that the conditions for
capitalization are not yet met and thus does not capitalize any development cost related to such
other indications.
Subsequent to initial recognition, internally
-
generated intangible assets are reported at cost less
accumulated amortization and accumulated impairment losses, on the same basis as intangible
assets that are acquired separately.
Capitalized internal development expenditures for imlifidase’s previous production process were
completely amortized during the year 2018 and written-off in 2022.
Acquired intangible assets
Patents
The HBP-assay patent cost is amortized over the finite useful life of the underlying patent in the
amount of SEK 559 k for the year 2022 (2021: SEK 559 k). The patent cost is amortized over
sales, general and administration line item in the consolidated statement of profit or loss and
other comprehensive income.
HBP-assay is a method of analysis used to predict severe sepsis in emergency clinics. A first version
has been launched, primarily intended for research purposes and interested specialists. The HBP-
assay has been licensed to a cooperating partner, Axis-Shield Diagnostics Ltd. (Axis-Shield), which is
currently developing a fully commercial product. The Company receives milestone compensation and
additional royalty revenue upon the sale of the sublicensed technology.
In-process development projects
Certain projects pending in the Group are a combination of acquired development projects and
continued activities in these projects. Of the total acquisition cost for acquired in-process
development projects, approximately 75% relates to imlifidase and 25% relates to HBP-assay.
The acquired intangible asset relating to imlifidase presented as in-process development
projects will be amortized over the estimated useful life of the underlying asset. Following the
first commercial sale of imlifidase in Q1-2021 the Group started to amortize the SEK 25,136 k
from the period of first sale in Q1-2021. The estimated useful life is 12 years.
Acquired in-process development projects are assessed for possible impairment at least on an
annual basis and the impairment assessment on December 31, 2022, and 2021 demonstrated
that there was no need for impairment. The estimated recoverable amount supported by
external and internal valuation reports by far exceeds the assets’ carrying amount, resulting in
no impairment charges for the year 2022 and 2021.
Internally generated
Acquired intangible assets
(in thousands of SEK)
Capatalized
development costs
Patents
In-process
development
projects
Total Intangible
Assets
Cost:
Opening balance
January 1, 202
2
4,485
12,339
25,136
41,960
Write
-off
(4,485)
(4,485)
Internally developed
20,853
20,853
Effects of movements in
exchange rates
162
162
Closing balance
December 31, 202
2
20,853
12,501
25,136
58,490
Amortization:
Opening balance
January 1, 202
2
(4,485)
(6,619)
(2,094)
(13,199)
Write
-off
4,485
4,485
Amortization for the year
(758)
(2,094)
(2,852)
Effects of movements in
exchange rates
(58)
(58)
Closing balance
December 31, 202
2
(7,435)
(4,188)
(11,624)
Carrying amounts:
At January 1, 202
2
5,720
23,042
28,761
At December 31, 202
2
20,853
5,066
20,948
46,866
77
Notes to the Group Financial Statements continued
Internally generated
Acquired intangible assets
(in thousands of SEK)
Capitalized
development
expenditures
Patents
In-process
development
projects
Total Intangible
Assets
Cost:
Opening balance
January 1, 2021
4,485
1, 069
25,136
41,690
Effects of movements in
exchange rates
270
270
Closing balance
December 31, 2021
4,485
12,339
25,136
41,960
Amortization:
Opening balance
January 1, 2021
(4,485)
(5,794)
(10,280)
Amortization for the year
(747)
(2,094)
(2,841)
Effects of movements in
exchange rates
(78)
(78)
Closing balance
December 31, 2021
(4,485)
(6,619)
(2,094)
(13,199)
Carrying amounts:
At January 1, 2021
6,275
25,136
31,410
At December 31, 2021
5,720
23,042
28,761
Note 5
Property and Equipment
As of December 31,
(in
thousands of SEK)
2022
2021
Cost:
Opening balance January 1
14,451
11,871
Reclassification
(2,403)
Adjusted opening balance
12,048
11,871
Additions during the year
3,332
2,580
Closing balance December 31
15,380
14,451
Accumulated depreciation and impairment losses:
Opening balance January
(8,019)
(6,665)
Reclassification
2,403
Adjusted opening balance
(5,616)
(6,665)
Depreciation during the
period
(1,651)
(1,354)
Closing balance December
(7,267)
(8,019)
Carrying amounts:
At January 1
6,432
5,206
At December 31
8,113
6,432
78
Notes to the Group Financial Statements continued
Note 6
Right-of-Use Assets, Lease Liabilities
As of December 31,
(in thousands of SEK)
2022
2021
Leased assets:
Buildings
27,250
34,446
Equipment
135
271
Vehicles
338
556
27,723
35,273
Lease liabilities:
Non-current
21,326
28,491
Current
7,165
6,888
28,491
35,379
For the years ended December 31, 2022, and 2021, there were SEK 0.- and SEK 36,071k
respectively, in additions of right-of-use assets.
Depreciation charge of leased assets for the period
As of December 31,
(in thousands of SEK)
2022
2021
Buildings
(7,195)
(4,646)
Equipment
(135)
(169)
Vehicles
(220)
(174)
(7,550)
(4,989)
Interest expense (included in finance cost) amounted to SEK 1,123k. Expenses related to low-
value leases and short-term leases amounted to SEK 1,918k. Total cash outflow of leases
amounted to SEK 9,904k.
Most of the Group’s operational leasing agreements involve leases of real property and
premises on which the business operations are conducted. The initial duration of the lease for
the Lund, Sweden, headquarters offices is three years from January 1, 2019. The agreement is
automatically extended with two years at a time unless cancellation is made no later than nine
months before the end of the contract period. There are no variable fees included in the leases.
The lease term covered by the extension option was not included in the lease term when the
lease was originally recognized as the Group did not consider that the exercise of the option
would be reasonably certain.
The Group has entered into lease agreements with respect to office space, IT and office
equipment. The leases are non-cancellable for various periods up to 2023.
Note 7
Inventories
Inventories include material, labour and overhead and consisted of the following:
As of December 31,
(in
thousands of SEK)
2022
2021
Raw materials and supplies
3,783
3,141
Work in process
13,455
8,282
Packaging material
502
311
Finished goods
3,814
1,882
Total inventories, gross
21,555
13,616
Less: provision for excess & obsolete inventories
(20,582)
(13,374)
Total inventories, net
973
242
In 2022, the Company recorded a provision for excess and obsolete inventories in the amount
of SEK 20.6 million (2021: SEK 13,4m) to account for the potential expiry of inventories ahead
of their commercial use.
79
Notes to the Group Financial Statements continued
Note 8
Trade Receivables, unbilled revenues and refund liabilities
Trade receivables and unbilled revenues
As of December 31,
(in thousands of SEK)
2022
2021
Trade receivables, net of provisions
8,360
9,712
Unbilled revenue, net of provisions
34,600
Total trade receivables and unbilled revenues
42,959
9,712
Trade receivables primarily consist of receivables from product sales to healthcare
organisations in European countries. During the periods ended December 31, 2022, and
December 31, 2021 respectively, the Company did not incur any losses from defaults related to
its trade receivables.
Unbilled revenues primarily relate to product sales to healthcare organisations in European
countries with the Group’s right to consider product sold despite not billed at the reporting date.
During the periods ended December 31, 2022, and December 31, 2021 respectively, the
Company did not incur any losses from defaults related to its unbilled revenues.
A provision for expected credit losses amounting to SEK 78k was recorded for 2022 (2021: SEK
0), see further discussion about credit risk in Note 20.
Refund liabilities
As of December 31,
(in thousands of SEK)
2022
2021
Volume discounts
14,039
All other
12,974
Total refund liabilities
27,013
Refund liabilities primarily consist of the Group’s actual or estimated rebates, discounts, return
and charge back obligations to its customers.
Note 9
Prepaid expenses and accrued income
As of December 31,
(in thousands of SEK)
2022
2021
Insurance
s
1,137
829
Healthcare conference
2,604
124
Software
1,777
1,177
Pension
1,770
1,644
Rent
2,385
2,512
Legal expenses
9,989
8,325
License fees
3,857
230
R&D expenses
7,587
3,769
Other
2,171
2,279
Total
33,278
20,889
Note 10
Other receivables
As of December 31,
(in
thousands of SEK)
2022
2021
VAT receivables
21,179
9,827
Advance payments to suppliers
9,262
11,292
Other receivables
874
1,419
Total
31,315
22,538
80
Notes to the Group Financial Statements continued
Note 11
Accrued Expenses
As of December 31,
(in thousands of SEK)
2022
2021
Annual leave accrual
18,267
15,879
Accrued social security contribution on salaries
5,243
4,395
Accrued short term incentives, incl. related social security contributions
33,138
24,146
R&D project costs
26,701
7,791
License fees
5,500
Consulting fees
16,845
17,600
Other
3,052
2,651
Closing balance December 31
108,747
72,462
Note 12
Other liabilities—Current
As of December 31,
(in thousands of SEK)
2022
2021
Personnel related liabilities
18,121
13,358
VAT liabilities
158
190
Closing balance December 31
18,278
13,548
Note 13
Revenue
The Group’s revenue from its contracts with customers is primarily generated from product
sales and three license agreements, as further described below. Revenue has been recognized
in the consolidated statement of profit or loss and other comprehensive income (loss) with the
following amounts:
Years Ended December 31,
(in thousands of
SEK)
2022
2021
Revenue from contracts with customers:
Product sales
86,735
15,017
Contract revenue, Axis
-Shield agreement
2,892
2,624
Cost reimbursement, Axis
-Shield agreement
624
527
Contract revenue, Sarepta
, AskBio agreements
64,273
15,710
Total revenue
154,525
33,878
The revenue with external customers is split as follows by geography:
Years Ended December 31,
(in thousands of
SEK)
2022
2021
Geography:
Sweden
4,678
North America
64,273
15,710
Europe (ex Sweden)
85,573
18,168
Total revenue
154,525
33,878
Performance Obligations Satisfied Over Time
The transaction price is allocated to each performance obligation according to their stand-alone
selling prices and is recognized when control of the goods or services are transferred to the
customer, either over time or at a point in time, depending on the specific terms and conditions
in the contracts.
For the Group’s current licensing arrangements, our professionals are required to be committed
throughout the development period. Therefore, promises such as the license, materials or
professional support are one performance obligation. Accordingly, upfront payments are
recognized over time.
81
Notes to the Group Financial Statements continued
Variable Consideration
In the transaction price, variable consideration, including milestone payments, is only included
to the extent that it is highly probable that a significant reversal in the amount of cumulative
revenue recognized will not occur when the uncertainty associated with the variable
consideration is subsequently resolved. Therefore, royalties and milestone payments from
licensing arrangements are constrained for the periods ended December 31, 2022, and 2021,
with the exception of the Axis-Shield minimum royalty payment.
Product sales
For the period ended December 31, 2022, the Group recorded product sales of SEK 86.7
million (2021: SEK 15.0 million). Product sales are recognized net of any sales and value-added
taxes and sales deductions based on contractually agreed payment terms.
License Agreement with Sarepta
On July 1, 2020, the Company executed an agreement with Sarepta. Sarepta was granted an
exclusive, worldwide license to develop and promote imlifidase, in addition to access to the
Group’s materials and professional support as a pre-treatment to enable Sarepta’s gene
therapy treatment in Duchenne muscular dystrophy (DMD) and Limb-girdle muscular dystrophy
(LGMD). The pre-treatment is intended for patients with pre-existing neutralizing antibodies
(NAb-positive patients) to adeno-associated virus (AAV), the technology that is the basis for
Sarepta’s gene therapy products.
Sarepta is responsible for conducting preclinical and clinical studies with imlifidase and any
subsequent potential filings for regulatory approvals. Sarepta will also be responsible for the
promotion of imlifidase as a pre-treatment to Sarepta’s gene therapies following potential
approval.
Under the terms of the agreement, the Company received a $10.0 million (SEK 81.9 million)
non-refundable upfront payment in July 2020 and is eligible for a total of up to $397.5 million in
development, regulatory and sales milestone payments. The Company will record all sales of
imlifidase and earn high single-digit to mid-teens royalties on Sarepta’s incremental gene
therapy sales when treating NAb-positive patients enabled by pre-treatment with imlifidase.
The exclusive worldwide license to develop and promote imlifidase was determined to be not
distinct as Sarepta cannot benefit from the license without the Group’s materials and
professional support and therefore the license and related support that includes the
requirements to provide the Group’s materials and professional support are one performance
obligation.
The upfront payment will be recognized over the development period, currently estimated at 51
months, as the Group fulfils its performance obligation under the Agreement. The Company
concluded that labour hours expended by the Group’s professionals was the appropriate
measure of the transfer of control of the combined promises of the license, Hansa materials and
professional services as it is the measure that is most indicative of the performance obligation
satisfied.
For the milestone payments associated with the development and regulatory milestones, the
Group concluded that the successful completion of the development and regulatory activities
are not probable at this time since the project is still in preclinical stage and therefore will not
recognize any of these milestones for the Group’s December 31, 2022, financial reporting
period. Revenue from performance-based and sales-based milestones and sales-based
royalties will be constraint because it is not probable that a reversal of revenue will not occur if
these were recognized.
For the period ended December 31, 2022, the Group recorded contract revenue in the amount
of SEK 26.8 million (2021: SEK 15.7 million) related to its agreement with Sarepta in connection
with the upfront payment received in July 2020.
License Agreement with AskBio
On January 3, 2022, Hansa announced a collaboration agreement with AskBio (subsidiary of
Bayer AG), a fully integrated AAV gene therapy company dedicated to developing medicines
that improve the quality of life for patients with genetic diseases.
The collaboration was initiated during the first quarter of 2022. It is designed to evaluate the
potential use of imlifidase as a pre-treatment, prior to the administration of AskBio’s gene
therapy in Pompe disease, in a preclinical and clinical feasibility program for patients with pre-
existing NAbs to the adeno-associated viral vector used in AskBio’s gene therapy.
Under terms of the agreement, Hansa received a USD 5 million payment upon execution of the
agreement and AskBio has the exclusive option to negotiate a full development and
commercialization agreement following evaluation of the results from an initial phase 1/2 study.
The upfront payment will be recognized over the development period, currently estimated at 24
months from start of the collaboration, as the Group fulfils its performance obligation under the
Agreement. The Company concluded that delivery of Hansa materials was the appropriate
measure of the transfer of control of the combined promises of the Hansa materials and
professional services as it is the measure that is most indicative of the performance obligation
satisfied.
For the period ended December 31, 2022, the Group recorded contract revenue in the amount
of SEK 37.5 million related to its agreement with AskBio in connection with the upfront payment
received in January 2022.
82
Notes to the Group Financial Statements continued
License Agreement with Axis-Shield
In 2022, the Group recorded contract revenue in the amount of SEK 2.9 million (2021: SEK 2.6
million) under its agreement with Axis-Shield related to a minimum royalty payment of $250,000
and a commercial milestone payment of $60,000. The agreement entails a license to access the
Group’s intellectual property regarding HBP analysis during the license period. The agreement
requires the Group to conduct activities that substantially affect the intellectual property rights
during the license period, which in turn affects Axis-Shield as a license holder. Royalty
payments are accrued and recognized as income during the period to which the royalty refers.
The minimum royalty amount was received in February 2021, initially recorded as a deferred
revenue and recognized as revenue over the reporting period on a straight-line basis. The
commercial milestone relates to achieved sales. Since it is a sales-based milestone it has been
recognized as revenue when the sales occurred and the Company became entitled to receive
the milestone payment.
In addition, the Group recorded revenue related to reimbursable costs upon rendering services
related to maintaining licensed patents in an amount of SEK 0.6 million (2021: SEK 0.5 million).
Deferred revenue
As of December 31,
(in thousands of SEK)
2022
2021
Opening balance January 1,
71,981
79,432
Addition under existing contracts
90,251
18,168
Addition under new contracts (AskBio agreement)
45,750
Revenue recognized
(154,525)
(33,878)
Adjustments, foreign exchange
16,473
8,259
Closing balance December 31,
69,930
71,981
Revenue may vary from period to period as revenue comprises product sales, royalties,
milestone payments, deferred revenue, and reimbursement of certain expenses.
Note 14
Staff Costs
Total personnel expenses recorded in the Group broken down to senior management, which
includes the Board of Directors and executive management, and other employees:
Year Ended December 31, 2022
(in thousa
nds of SEK)
Senior
Management
Other Employees
Total
Salaries, bonuses
, and other benefits
36,927
153,642
190,569
Social security contribution
11,423
24,636
36,059
Pension cost, contribution plan
2,812
21,307
24,118
Share
-based compensation
32,844
25,382
58,226
Total personnel expenses
84,005
224,967
308,972
Year Ended December 31, 2021
(in thous
ands of SEK)
Senior
Management
Other Employees
Total
Salaries, bonuses
, and other benefits
32,282
122,304
154,586
Social security contribution
10,040
20,518
30,558
Pension cost, contribution plan
2,723
15,381
18,104
Share
-based compensation
33,860
22,764
56,624
Total
personnel expenses
78,905
180,967
259,872
Share-based payments
Long-term incentive program 2018 (LTIP 2018)
At Hansa’s Annual General Meeting (AGM) on May 29, 2018, shareholders resolved to adopt a
long-term incentive program (LTIP 2018). Participants in the program were given the
opportunity to acquire equity-based awards (warrants) at market value and/or receive share
rights free of charge which, provided that certain conditions are met, may give the right to
acquire shares in the Company.
83
Notes to the Group Financial Statements continued
Warrants under LTIP 2018
Each warrant gives the participant the right to exercise the warrant for subscription of one
ordinary share in the Company at a price equal to the market value of the share at the time of
the issuance of the warrants (SEK 223.10) adjusted upwards in the amount of 7% annually
during the three-year vesting period, i.e., SEK 273.31. Provided the participant remains an
employee of the Group, subscription for shares in accordance with the terms of the warrants
may take place during the period from June 12, 2021 through June 12, 2022.
The warrants were sold to the participants on market terms at a price established on the basis
of an estimated market value of the warrants using the Black Scholes model. In connection with
the warrants program participants (except the CEO) received a subsidy of maximum 25% of the
purchase price.
Should the participant’s employment cease before the awards are exercised, the Group is
entitled to repurchase the awards at market value less any subsidy provided to the participant.
A total of 6,701 warrants were sold under the program in June 2018.
The Group used the following inputs when valuing the warrants under LTIP 2018 based on
Black Scholes model:
Issuance June
2018
Underlying volume-weighted average share price, SEK
223.10
Risk-free interest rate, (%)
(0.178)
Expected volatility, (%)
43
Expected dividend, SEK
Calculated fair value per warrant, SEK
53.41
Years Ended December 31,
2022
2021
Warrants, Opening balance January 1
6,701
6,701
Warrants expired or redeemed in advance during the period
(6,701)
Warrants, Closing balance December 31
0
6,701
Recorded share-based compensation expenses, thousands of SEK
0
5
Share rights under LTIP 2018
Each share right provides a participant the right to acquire one ordinary share in the Company
free-of-charge provided certain pre-defined conditions are met in accordance with the terms of
LTIP 2018. A share right may be exercised if the performance condition is met and provided
that the participant, with certain exceptions, from the date of the start of participation in LTIP
2018 up until and including the date three years thereafter (the Vesting Period) maintains his or
her employment within the Group.
The single performance condition is: TSR during the Vesting Period compared to a starting
value of SEK 222.10 (allotment June 2018), SEK 278.70 (allotment November 2018) and
SEK178.60 (allotment May 2019). The performance condition is set at a “minimum level” of 25%
and “maximum level” of 100%, whereby the number of shares granted to participants is
increased lineally between the minimum level and maximum level in line with the TSR
appreciation.
A total of 260,710 share rights were allotted to participants, of which 105,460 were allotted in
June 2018, 72,671 were allotted in November 2018 and 82,579 were allotted in May 2019.
The Group used the following inputs when valuing the share rights under LTIP 2018 based on
Monte Carlo simulation:
Allotment
June 15, 2018
Allotment
Nov 30, 2018
Allotment
May 14, 2019
Starting value (base
-line share price) for TSR
calculation, SEK
221.10
278.70
178.60
Risk
-free interest rate, (%)
(0.36)
(0.28)
(0.55)
Expected volatility, (%)
43
43
43
Expected dividend, SEK
Calculated fair value per
share right, SEK
94.08
117.43
76.02
Years Ended December 31,
2022
2021
Share rights, Opening balance January 1
60,086
223,778
Share rights
expired or forfeited during the period
(60,086)
(163,692)
Share rights, Closing balance December 31
0
60,086
Recorded share
-based compensation expenses, thousands of SEK
294
912
84
Notes to the Group Financial Statements continued
Long-term incentive program 2019 (LTIP 2019)
At Hansa’s AGM on May 22, 2019, shareholders resolved to adopt a long-term incentive
program, LTIP 2019. Under the terms of LTIP 2019, participants in the program could receive
performance-based share rights (share rights) free of charge and/or share options, as further
described below.
Share rights under LTIP 2019
Each share right provides a participant the right to acquire one ordinary share in the Company
free-of-charge provided certain pre-defined performance conditions are met and provided that
the participant, with certain exceptions, from the date of the start of participation in LTIP 2019
up until and including the date three years thereafter (the Vesting Period) maintains his or her
employment within the Group.
The final number of ordinary shares a participant is entitled to receive is, amongst other terms,
conditional upon meeting the following performance conditions during the Vesting Period:
>
Condition 1 (accounting for 22%): Obtain market approval in the EU by the EMA
>
Condition 2 (accounting for 22%): At least 10 patients enrolled in US RCT (ConfIdes)
>
Condition 3 (accounting for 56%): TSR of at least 25% against the baseline share price at the
date of allotment.
In December 2021, Hansa’s Board of Directors in line with the terms and conditions of the LTIP
2019 resolved to adjust Condition 2 from the previous condition “Imlifidase U.S. approval“ to the
new condition „At least 10 patients enrolled in US RCT (ConfIdes)”.
A total of 306,303 share rights were allotted to participants, of which 288,727 were allotted in
June 2019, and 17,576 were allotted in October 2019.
The Group used the following inputs when valuing the share rights under LTIP 2019 based on
Monte Carlo simulation:
Allotment
June 17, 2019
Allotment
Oct 24, 2019
Starting value (base-line share price) for TSR calculation, SEK
178.38
129.28
Risk-free interest rate, (%)
(0.59)
(0.41)
Expected volatility, (%)
43
43
Expected dividend, SEK
Calculated fair value per share right, SEK
122.12
89.00
Years Ended December 31,
2022
2021
Share rights, Opening balance January 1
278,181
287,555
Share rights
lapsed or forfeited during the period
(155,781)
(9,374)
Share rights vested during the period
122,400
Share rights, Closing balance December 31
0
278,181
Recorded share
-based compensation expenses, thousands of SEK
3,509
12,906
Share options under LTIP 2019
The share option program consists of two option series: Series 1—Warrants, and Series 2—
Employee stock options.
Each warrant or employee stock option entitles the holder to receive one new ordinary share in
the Company at an exercise price corresponding to 110% of the volume weighted average
share price during the 10 trading days immediately prior to the offer to subscribe for the
instruments, and provided that the participant, with certain exceptions, from the date of the start
of participation in LTIP 2019 up until and including the date three years thereafter (the Vesting
Period) maintains his or her employment within the Group.
LTIP 2019, Warrants
A total of 11,000 warrants were sold to participants in June 2019. In connection with the
warrants program participants (except the CEO) received a subsidy of up to 100% of the
purchase price.
The Group used the following inputs when valuing the warrants under LTIP 2019 based on
Black Scholes model:
Issuance
June 17, 2019
Underlying volume
-weighted average share price, SEK
178.38
Exercise price, SEK
196.20
Risk
-free interest rate, (%)
(0.59)
Warrant term, years
3
Expected volatility, (%)
43
Expected dividend, SEK
Calculated fair value per
warrant, SEK
45.54
85
Notes to the Group Financial Statements continued
Years Ended December 31,
2022
2021
Warrants, Opening balance January 1
11,000
11,000
Warrants expired or redeemed in advance during the period
(11,000)
Warrants, Closing balance December 31
0
11,000
Recorded share-based compensation expenses, thousands of SEK
28
97
LTIP 2019, Employee Stock Options (ESOs)
A total of 149,148 ESOs were issued to participants in June 2019.
The Group used the following inputs when valuing the ESOs under LTIP 2019 based on Black
Scholes model:
Issuance
June 17, 2019
Underlying volume-weighted average share price, SEK
178.38
Exercise price, SEK
196.20
Risk-free interest rate, (%)
(0.59)
ESO term, years
3
Expected volatility, (%)
43
Expected dividend, SEK
Calculated fair value per ESO, SEK
45.19
Years Ended December 31,
2022
2021
ESO, Opening balance January 1
149,148
149,148
ESO forfeited or expired during the period
ESO, Closing balance December 31
149,148
149,148
Recorded share-based compensation expenses, thousands of SEK
930
690
Long-term incentive program 2020 (LTIP 2020)
At Hansa’s AGM on June 23, 2020, shareholders resolved to adopt a long-term incentive
program, LTIP 2020. Under the terms of LTIP 2020 participants in the program may receive
share rights free of charge and/or ESOs as further described below.
Share rights under LTIP 2020
Each share right entitles a participant to acquire one ordinary share in the Company at no cost
provided certain pre-defined performance conditions are met and the employment is maintained
within the Group during the vesting period. Each share right carries a vesting period of three
years commencing on the day of its allotment to a participant (the Vesting Period).
The final number of ordinary shares a participant is entitled to receive is, amongst other terms,
conditional upon meeting the following performance conditions during the Vesting Period:
>
Condition 1 (accounting for 22%): The U.S. randomized controlled trial (ConfIdeS) has
enrolled 64 patients;
>
Condition 2 (accounting for 11%): Top-line data read out of the ongoing Phase 2 study in
either AMR or GBS is completed with data providing a solid scientific rational for a path
forward;
>
Condition 3 (accounting for 11%): At least 70% of the targeted transplantation centers in
Europe have been initiated;
>
Condition 4 (accounting for 56%): TSR of at least 25% against the baseline share price at the
date of allotment.
In December 2021, Hansa’s Board of Directors in line with the terms and conditions of the LTIP
2020 resolved to adjust Condition 1 from the previous condition “The U.S. randomized
controlled trial is completed during the Vesting Period“ to the new condition „US RCT study
(ConfIdeS) fully enrolled”. In December 2022, , Hansa’s Board of Directors in line with the terms
and conditions of the LTIP 2020 resolved to adjust (a) Condition 1 from the previous condition
“US RCT study (ConfIdeS) fully enrolled” to the new condition “The U.S. randomized controlled
trial (ConfIdeS) has enrolled 64 patients”, and (b) Condition 2 from the previous condition “Top-
line data read out of the ongoing Phase 2 study in either AMR or GBS is completed with data
providing a solid scientific rational to continue either of the two programs” to the new condition
“Top-line data read out of the ongoing Phase 2 study in either AMR or GBS is completed with
data providing a solid scientific rational for a path forward”.
A total of 417,556 share rights were allotted to participants, of which 401,556 were allotted in
July 2020 and 16,000 were allotted in February 2021.
86
Notes to the Group Financial Statements continued
The Group used the following inputs when valuing the share rights under LTIP 2020 based on
Monte Carlo simulation:
Allotment
July 23,2020
Allotment
Feb 12, 2021
Starting value (base-line share price) for TSR calculation, SEK
252.60
252.60
Risk-free interest rate, (%)
(0.33)
(0.25)
Expected volatility, (%)
43
43
Expected dividend, SEK
Calculated fair value per share right, SEK
173.26
120.07
Years Ended December 31,
2022
2021
Share rights, Opening balance January 1
400,556
389,556
Allotted to participants February 12, 2021
16,000
Share rights forfeited
(2,245)
(5,000)
Share Rights, Closing balance December 31
398,311
400,556
Recorded share-based compensation expenses, thousands of SEK
21,607
21,205
Employee Stock Options under LTIP 2020
Each ESO entitles the holder to receive one new ordinary share in the Company at an exercise
price corresponding to 125% of the volume weighted average share price during the 10 trading
days immediately prior to the offer to subscribe for the instruments, and provided that the
participant, with certain exceptions, from the date of the start of participation in LTIP 2020 up
until and including the date three years thereafter (the Vesting
Period) maintains his or her
employment within the Group.
A total of 507,520 ESOs were issued to participants of which 487,520 were issued in July 2020
and 20,000 were issued in February 2021.
The Group used the following inputs when valuing the ESOs under LTIP 2020 based on Black
Scholes model:
Issuance
July 23,2020
Issuance
Feb 12, 2021
Underlying volume
-weighted average share price, SEK
252.60
185.13
Exercise price, SEK
315.75
315.75
Risk
-free interest rate, (%)
(0.33)
(0.25)
ESO term, years
3
3
Expected volatility, (%)
43
43
Expected dividend, SEK
Calculated
fair value per ESO, SEK
53.05
27.25
Years Ended December 31,
2022
2021
ESO, Opening balance January 1
497,520
477,520
ESO allotted to participants
February 12, 2021
20,000
ESO forfeited
(10,000)
ESO, Closing balance December 31
487,520
497,520
Recorded share
-based compensation expenses, thousands of SEK
7,808
7,658
Long-term incentive program 2021 (LTIP 2021)
At Hansa’s AGM on May 12, 2021, shareholders resolved to adopt a long-term incentive
program, LTIP 2021. Under the terms of LTIP 2021 participants in the program may receive
share rights free of charge and/or ESOs as further described below.
Share rights under LTIP 2021
Each share right entitles a participant to acquire one ordinary share in the Company at no cost
provided certain pre-defined performance conditions are met and the employment is maintained
within the Group during the vesting period. Each share right carries a vesting period of three
years commencing on the day of its allotment to a participant (the Vesting Period).
87
Notes to the Group Financial Statements continued
The final number of ordinary shares a participant is entitled to receive is, amongst other terms,
conditional upon meeting the following performance conditions during the Vesting Period:
>
Condition 1 (accounting for 22%): U.S. FDA has accepted a BLA filing for approval of
imlifidase in the U.S.;
>
Condition 2 (accounting for 11%): A phase 3 study in either AMR or GBS is initiated or a filing
for regulatory approval is accepted by either the FDA or EMA for one of these indications or
anti-GBM;
>
Condition 3 (accounting for 11%): At least 80% of the targeted transplantation centers in
Europe have been initiated; and
>
Condition 4 (accounting for 56%): TSR of at least 25% against the baseline share price at the
date of allotment.
A total of 557,000 share rights were allotted to participants in June 2021.
Allotment
June 7, 2021
Starting value (base-line share price) for TSR calculation, SEK
153.75
Risk-free interest rate, (%)
(0.18)
Expected volatility, (%)
46.9
Expected dividend, SEK
Calculated fair value per share right, SEK
98.94
Years Ended December 31,
2022
2021
Share rights, Opening balance January 1
557,000
Allotted to participants June 7, 2021
557,000
Share rights forfeited
(5,737)
Share Rights, Closing balance December 31
551,263
557,000
Recorded share-based compensation expenses, thousands of SEK
7,948
11,722
Employee Stock Options under LTIP 2021
Each ESO entitles the holder to receive one new ordinary share in the Company at an exercise
price corresponding to 125% of the volume weighted average share price during the 30 trading
days immediately prior to the offer to subscribe for the instruments, and provided that the
participant, with certain exceptions, from the date of the start of participation in LTIP 2021 up
until and including the date three years thereafter (the Vesting
Period) maintains his or her
employment within the Group.
A total of 430,000 ESOs were issued to participants in June 2021.
The Group used the following inputs when valuing the ESOs under LTIP 2021 based on Black
Scholes model:
Issuance
June 7, 2021
Underlying volume
-weighted average share price, SEK
153.70
Exercise price, SEK
192.20
Risk
-free interest rate, (%)
(0.04)
ESO term, years
4.5
Expected volatility, (%)
46.9
Expected dividend, SEK
Calculated
fair value per ESO, SEK
42.98
Years Ended December 31,
2022
2021
ESO, Opening balance January 1
430,000
ESO allotted to participants
June 7, 2021
430,000
ESO forfeited
ESO, Closing balance December 31
430,000
430,000
Recorded share
-based compensation expenses, thousands of SEK
5,892
3,738
88
Notes to the Group Financial Statements continued
Long-term incentive program 2022 (LTIP 2022)
At Hansa’s AGM on June 30, 2022, shareholders resolved to adopt a long-term incentive
program, LTIP 2022. Under the terms of LTIP 2022 participants in the program may receive
share rights free of charge and/or ESOs as further described below.
Share rights under LTIP 2022
Each share right entitles a participant to acquire one ordinary share in the Company at no cost
provided certain pre-defined performance conditions are met and the employment is maintained
within the Group during the vesting period. Each share right carries a vesting period of three
years commencing on the day of its allotment to a participant (the Vesting Period).
The final number of ordinary shares a participant is entitled to receive is, amongst other terms,
conditional upon meeting the following performance conditions during the Vesting Period:
>
Condition 1 (accounting for 22%): U.S. FDA has approved imlifidase in the U.S.;
>
Condition 2 (accounting for 11%): Imlifidase has been approved, or a Marketing Authorization
Application/Biologics License Application has been submitted, in any jurisdiction in an
indication outside kidney transplant;
>
Condition 3 (accounting for 11%): At least 80% of the targeted transplantation centers in
Europe have had repeat business
>
Condition 4 (accounting for 56%): TSR of at least 25% against the baseline share price at the
date of allotment.
A maximum of 624,615 share rights can be allotted under LTIP 2022. As of December 31, 2022,
a total of 543,000 share rights have initially been allotted to participants.
The Group used the following inputs when valuing the share rights under LTIP 2022 based on
Monte Carlo simulation:
Allotment
July 20, 2022
Starting value (base-line share price) for TSR calculation, SEK
56.0
Risk-free interest rate, (%)
(1.87)
Expected volatility, (%)
58.6
Expected dividend, SEK
Calculated fair value per share right, SEK
80.29
Year Ended
December 31, 2022
Share rights, Opening balance January 1
Allotted to participants
July 20, 2022,
543,000
Share rights forfeited
Share Rights, Closing balance December 31
543,000
Recorded share
-based compensation expenses, thousands of SEK
7,277
Employee Stock Options under LTIP 2022
Each ESO entitles the holder to receive one new ordinary share in the Company at an exercise
price corresponding to 125% of the volume weighted average share price during the 30 trading
days immediately prior to the offer to subscribe for the instruments, and provided that the
participant, with certain exceptions, from the date of the start of participation in LTIP 2022 up
until and including the date three years thereafter (the Vesting
Period) maintains his or her
employment within the Group.
A maximum of 452,307 ESOs can be allotted under LTIP 2022. As of December 31, 2022, a
total of 384,000 have initially been allotted to participants.
89
Notes to the Group Financial Statements continued
The Group used the following inputs when valuing the ESOs under LTIP 2022 based on Black
Scholes model:
Issuance
July 20, 2022
Underlying volume-weighted average share price, SEK
56.01
Exercise price, SEK
70.0
Risk-free interest rate, (%)
(1.86)
ESO term, years
4.5
Expected volatility, (%)
58.6
Expected dividend, SEK
Calculated fair value per ESO, SEK
52.45
Year Ended
December 31, 2022
ESO, Opening balance January 1
ESO allotted to participants July 20, 2022
384,000
ESO forfeited
ESO, Closing balance December 31
384,000
Recorded share-based compensation expenses, thousands of SEK
2,934
Note 15
Provisions
Provisions relate to social security contributions linked to outstanding share or option rights in
the Group’s ongoing incentive programs. The social security contributions are expected to be
incurred after vesting if and when plan participants realize value under their specific rights under
the LTIP programs. Please refer to Note 14 related to the Group’s LTIP programs and
respective vesting dates.
The decrease in provisions for 2022 was mainly driven by impact of the decrease in the
Company’s share price that resulted in lower provision for social security contributions under the
LTIP programs.
As of December 31,
2022
2021
Opening balance January 1
7,357
14,426
Change in p
rovision related to LTIP 2018
(2,999)
Change in p
rovision related to LTIP 2019
(2,910)
(4,516)
Change in p
rovision related to LTIP 2020
(216)
(1,194)
Change in p
rovision related to LTIP 2021
(357)
1,866
Change in p
rovision related to LTIP 2022
1,318
Change in p
ension provision
(226)
Closing balance December 31
5,192
7,357
Note 16
Income Taxes
As of December 31,
(in
thousands of SEK)
2022
2021
Deferred Taxes, opening balance January 1
426
424
Tax income in the consolidated statement of profit or loss and other
comprehensive income
(41)
(39)
Currency differences for the year
20
41
Deferred Taxes, closing balance December 31
405
426
Losses carried forward in 2022
Deferred tax assets have not been recognized regarding temporary differences and losses
carried forward since it is not probable that such can be set off against taxable profits in the
foreseeable future.
The Group’s losses carried forward in 2022 amounted to SEK 2,361,926,000 (2021: SEK
1,855,521,000). The losses carried forward is, in all material respects, attributable to Swedish
companies and therefore has no due date.
90
Notes to the Group Financial Statements continued
A reconciliation of Hansa’s effective tax rate relative to the Swedish statutory tax rate is as
follows:
2022
2021
%
(in thousands
of SEK)
%
(in thousands
of SEK)
Result before tax
(609,979)
(548,130)
Tax according to current tax rate
20.6
125,656
20.6
112,915
Effect of other tax rates for foreign
subsidiaries
0
(21)
0
(14)
Non-deductible expenses
(3.6)
(21,920)
(2.4)
(13,103)
Increase in loss carry-forwards without
corresponding capitalization of deferred tax
(17.2)
(104,869)
(18.2)
(99,951)
Reported effective tax
(0.2)
(1,155)
(152)
The corporate tax rate in Sweden is 20.6%, from January 1, 2021.
Note 17
Earnings per share
Years Ended December 31,
(in SEK)
2022
2021
Loss per share, basic and diluted
(13.60)
(12.33)
Diluted net loss per share is computed using the weighted-average number of ordinary shares
outstanding during the period, plus the dilutive effect of potential ordinary shares. Diluted net
loss per share does not differ from basic net loss per share since potential ordinary shares from
the conversion of share rights, stock options and warrants are antidilutive for all periods
presented and are, therefore, excluded from the calculation. For the year ended December 31,
2022, and 2021, share rights to receive 1,492,574 and 1,295,823 ordinary shares, respectively,
options to purchase 1,450,668 and 1,076,668 ordinary shares, respectively, were not included
in the computation of diluted loss per share since their inclusion would be antidilutive.
The calculation of the numerator and denominator used in the above stated calculations of loss
per share are stated below.
Loss attributable to ordinary shareholders, basic and diluted
Years Ended December 31,
(in thousands of SEK)
2022
2021
Loss for the year attributable to owners of the parent
(611,134)
(548,280)
Loss attributable to ordinary shareholders, basic and diluted
(611,134)
(548,280)
Weighted average number of ordinary shares, basic and diluted
Years Ended December 31,
(in thousands of SEK)
2022
2021
Outstanding
ordinary shares January 1
44,473,452
44,473,452
Effect of
conversion of C to A shares in June 2022
62,202
Effect of
conversion of C to A shares in October 2022
1,314
Effect of
issue of ordinary shares in December 2022
387,030
Weighted average number of ordinary shares, basic and diluted
44,923,998
44,473,452
Note 18
Contingent Consideration
The Group acquired Immago Ltd (today Hansa Biopharma Ltd) on July 19, 2016. The agreed
upon purchase price was GBP 170,000. An additional GBP 70,000 milestone payment is to be
paid if a clinical study based on the acquired technology is initiated in Europe or the U.S. The
estimated payment date is July 2024, resulting in a fair value of the contingent liability on
December 31, 2022 amounting to SEK 757,000 (2021: SEK 722,000).
The estimated future cash flow is discounted using a 10% risk adjusted interest rate. See further
discussions in Note 20.
Note 19
Capital Management
The Board of Directors’ policy is to maintain a strong capital base to maintain investor, creditor
and market confidence, and a continuous advancement of Hansa’s product pipeline and
business in general. Hansa has financed its operations mostly from shareholders equity through
the issuance of shares. As of December 31, 2022, The Group’s cash position (including short-
term investments) amounted to SEK 1,496 million.
91
Notes to the Group Financial Statements continued
The adequacy of available funds will depend on many factors, including growth of Idefirix sales,
progress in research and development programs, the magnitude of those programs,
commitments to existing and new collaborators, the ability to establish commercial and licensing
arrangements, capital expenditures, market developments, and any potential future
acquisitions. Accordingly, Hansa may require additional funds and may attempt to raise
additional funds through equity or debt financings, collaborative agreements with partners, or
from other sources.
The Board of Directors monitors the share and capital structure to ensure that Hansa’s capital
resources support the strategic goals. Neither the Company nor any of its subsidiaries are
subject to externally imposed capital requirements. Managed capital is all reported equity.
Note 20
Financial Risk and Financial Instruments
The Group has exposure to the following risks arising from financial instruments:
A. Liquidity risk
B. Market risk
C. Credit risk
Risk management framework
The Group’s board of directors has overall responsibility for the establishment and oversight of
the Group’s risk management framework. The Group’s risk management policies are
established to identify and analyze the risks faced by the Group, to set appropriate risk limits
and controls and to monitor risks and adherence to limits. Risk management policies and
systems are reviewed to reflect changes in market conditions and the Group’s activities. The
Group, through its training and management standards and procedures, aims to maintain a
disciplined and constructive control environment in which all employees understand their roles
and obligations. The Group’s audit committee oversees how management monitors compliance
with the Group’s risk management policies and procedures and reviews the adequacy of the
risk management framework in relation to the risks faced by the Group. The Group’s audit
committee is assisted in its oversight role by corporate finance function. Corporate finance
function undertakes both regular and ad hoc reviews of risk management controls and
procedures, the results of which are reported to the audit committee.
Liquidity Risk
Liquidity risk is the risk that the Group will encounter difficulty in meeting the obligations
associated with its financial liabilities that are settled by delivering cash or another financial
asset. The Group’s approach to managing liquidity is to ensure, as far as possible, that it will
have sufficient liquidity to meet its liabilities when they are due, under both normal and stressed
conditions, without incurring unacceptable losses or risking damage to the Group’s reputation.
The Board of Directors is responsible for the long-term financing strategy and for the acquisition
of capital. The management of financial risks in the day-to-day operations is handled by the
CFO and the corporate finance function.
To secure short-term liquidity, Hansa’s treasury policy prescribes that an appropriate level of
liquidity in the form of cash and cash equivalents shall be held in an amount sufficient to cover
the expected Group financial obligations over at least the next nine-month period. This principle
shall be checked and assured every time a new investment decision is taken. On the reporting
date, this goal was fulfilled.
Cash and cash equivalents on December 31, 2022, amounted to SEK 1,496 million. Cash and
cash equivalents on the reporting date consisted of bank deposits.
Short term investments were mainly invested in interest funds and amounted to SEK 238 million
as of December 31, 2021.
The Group sold all its investments in interest funds during the year
2022 – see further information in the Cash Flow Statement.
Set forth below is a term-based analysis of the Group’s remaining contractual financial liabilities:
As of December 31, 2022
(in
thousands of SEK)
Nominal
Amount
0
3 months
3
12 months
1
5 years
5
7 years
Long
-term loan
1,458,800
820,575
638,225
Contingent consideration
887
887
Non
-current leasing
liabilities
22,582
22,582
Current leasing liabilities
7,962
1,990
5,971
Trade
payables
62,476
62,476
Accrued expenses (see
note 11)
52,099
52,099
Total
1,604,805
116,565
5,971
844,044
638,225
92
Notes to the Group Financial Statements continued
As of December 31, 2021
(in thousands of SEK)
Nominal Amount
0
3 months
3
12 month
1
5 years
Contingent consideration
846
846
Non-current leasing liabilities
30,544
30,544
Current leasing liabilities
7,929
1,986
5,943
Trade payables
53,360
53,360
Accrued expenses (see note 11)
28,041
28,041
Total
120,720
83,387
5,943
31,390
Market Risk
Market risk is the risk that changes in market prices, e.g. foreign exchange rates, interest rates
and equity prices will affect the Group’s income or the value of its holdings of financial
instruments. The objective of market risk management is to manage and control market risk
exposures within acceptable parameters, while optimizing the return.
Currency risk
The Group is exposed to transactional foreign currency risk to the extent that there is a
mismatch between the currencies in which sales, purchases, receivables and borrowings are
denominated and the respective functional currencies of Group companies. The functional
currencies of Group companies are primarily the SEK, GBP and USD. The currencies in which
transactions are primarily denominated are SEK, EUR, GBP and USD. In 2022, the Company
took up a long-term loan in the amount of USD 70 million. The Company is exposed to USD
currency risk related to such loan as per the contractual repayment dates. Refer to Note 21 for
further information on the loan.
To manage the currency risk exposure, the Group may in its normal course of business, hold
funds in foreign currency or enter into currency forward contracts or similar instruments to
benefit from trends in exchange rates on the basis of a sophisticated analysis considering
exchange rate forecasts published by banks or other analysts as well as short and mid-term
currency needs of the Group.
All cash and investments shall only be made and held in Swedish Krona. In case of investments
in funds or the like, an investment can only be made if the currency fluctuation risk is fully
hedged by the fund.
As an exception to the above, the Group may hold cash in foreign currency in the normal course
of business to pay any trade payables in foreign currencies. Subsidiaries will hold cash in their
local currency within their normal course of business. The Group also has minimal amounts in
trade and other receivables in foreign currencies.
The Group is exposed to translation risk that arise from consolidation of foreign subsidiaries.
The Group net assets on December 31, 2022, relating to Hansa Biopharma Inc. amounted to
USD 574k (full year 2021: USD 210k) and the Group net assets relating to Hansa Biopharma
Ltd. amounted to GBP 102k (full year 2021: GBP 50k).
Sensitivity analysis
The Company purchases services mainly in USD, GBP, DKK and EUR. A weakening of the
Swedish krona in relation to these currencies therefore leads to increased costs for the Group,
all else remaining the same. In addition, the Group receives licensing revenue which are paid in
USD and GBP. A strengthening of the Swedish krona in relation to USD and GBP therefore
leads to reduced revenue for the Group expressed in SEK, all else remaining the same.
A weakening of the SEK in relation to EUR, USD, GBP and DKK by an average of 10% would
have negatively affected the Group’s earnings before tax by approximately SEK 14.6 million,
SEK 4.4 million, SEK 2.5 million, and SEK 0.5 million, respectively. This analysis assumes that
all other variables, in particular interest rates, remain constant and ignores any impact of
forecast sales and purchases.
The Company has taken up a long-term loan in the amount of USD 70 million in 2022. As of
December 31, 2022, the carrying amount of such loan is SEK 762.6 million. A strengthening of
the USD by 10% would have resulted in an increase in long-term liabilities in the amount of
approximately SEK 76.3 million.
The sensitivity analysis is based on approximated cash flows in foreign currencies. Income and
expenses of foreign operations are translated into Swedish kronor at an average exchange rate
that approximates the exchange rates presented at each transaction date.
Interest rate risk
The interest rate risk consists of the risk that a change in market interest rates will have a
negative effect on earnings. The Group’s exposure to interest rate risks is considered to be low
as the Group only has very limited interest-bearing liabilities. There is certain exposure to
interest rate risks in cash and cash equivalents in the form of bank deposits and holdings of
short-term interest fund.
The Group sold all its investments in interest funds during the year – see further information in
the Cash Flow Statement.
In 2022, the Company took up a long-term loan in the amount of USD 70 million. The Company
is not exposed to any material interest rate risk with regard to such loan as the repayment
amount is fixed at twice the principal loan amount.
93
Notes to the Group Financial Statements continued
Credit risk
Credit risk is the risk of financial loss to the Group if a customer or counterparty to a financial
instrument fails to meet its contractual obligations and arises principally from the Group’s
receivables from customers and investments in debt securities. The carrying amounts of
financial assets and unbilled revenues represent the maximum credit exposure.
The Group’s credit risk is primarily related to bank deposits. However, this risk is considered to
be low since the bank deposits are held with four Swedish banks with good credit ratings. See
further discussions in Note 2. According to the Group’s treasury policy, The Company may only
hold bank deposits with, or initiate payments through, Swedish and foreign banks under the
supervision of the Swedish Financial Supervisory Authority or similar foreign agency.
The Group has risk related to its trade receivables.
The Company determined that the country
risk premium was the appropriate factor to use as the default rate as this factor represents the
expected losses from default on the sovereign debt. The Company concluded these factors
could be generalized to its receivables from the Product sold in these geographies due to direct
or indirect involvement of the respective governments.
The Group has also risk related to other receivables that consist mainly of advance payments to
suppliers.
The credit risk is considered to be low as the Group uses trading history as an
evaluation factor and the amounts outstanding at year end 2022 are immaterial.
The maximum credit exposure of financial assets amounted to SEK 1,505,412 and SEK
662,473 for the periods ended December 31, 2022, and 2021, respectively.
Investment policy
The Group may invest a portion of its funds in bank deposits, bonds, investment funds and the
like with maturity of more than 35 days, while managing the interest rate risk exposure, credit
risk exposure as well as the cluster risk. As a general principle, the Group may only invest in
investment grade issuers, measured at the day of the investment.
Therefore, the following applies:
1) Minimum credit rating of one of the following rating agencies (or comparable):
S&P Rating
Moody’s rating
Up to one year
A-2
P2
More than one year
A
A
2) The maximum amount invested with one counterparty or issuer is limited to 30% of total
funds at the time a new investment decision is taken. This limit might be increased to up to 50%
upon prior approval by the Audit Committee.
3) The duration management within the portfolio of investments is the responsibility of the CFO.
The maximum maturity of an individual investment shall not exceed two years.
At year-end 2021, SEK 198 million of the Group’s short-term investments were invested in an
investment grade fixed income fund denominated in SEK that invests primarily in Swedish
interest-bearing securities with a remaining duration of maximum 360 days. Another SEK 40
million was invested in a housing bond fund which invests in investment grade assets
denominated in SEK.
The Group sold all its investments in interest funds during the year – see
further information in the Cash Flow Statement.
Carrying amounts of financial assets and financial liabilities
The table below shows the carrying amounts for financial assets and financial liabilities broken
down by measurement categories under IFRS 9.
Financial assets valued
at amortized cost
Financial assets valued at fair value
through the income statement
(in thousan
ds of SEK)
2022
2021
2022
2021
Financial assets:
Short term investments
237,619
Trade
receivables
8,360
9,712
Other receivables
874
1,419
Cash and cash equivalents
1,496,179
651,342
Total financial assets
1,505,412
662,473
237,619
Financial liabilities valued
at amortized cost
Financial liabilities valued at fair
value through the consolidated
statement of profit or loss and
other comprehensive income
(in thousa
nds of SEK)
2022
2021
2022
2021
Financial
liabilities:
Long
-term loan
762,601
Contingent consideration
757
722
Trade
payables
62,476
53,360
Accrued expenses (see note 11)
52,099
28,041
Total financial liabilities
877,176
81,401
757
722
94
Notes to the Group Financial Statements continued
Levels of financial assets and financial liabilities per valuation hierarchy
Management considers the carrying amounts for all financial assets and financial liabilities to be
a reasonable approximation of their fair value.
The table below presents the carrying amount of financial assets and financial liabilities per
valuation hierarchy in IFRS 13.
(In thousands of SEK)
Valuation
Hierarchy
2022
2021
Financial asset:
Holdings of short-term investments
Level 2
237,619
Contingent consideration
Level 3
757
722
The table below presents a reconciliation between the opening and closing balances for the
contingent consideration valuated in accordance with Level 3.
As of December 31,
(In thousands of SEK)
2022
2021
Opening balance January 1
722
663
Currency differences
89
42
Interest (expense) / income
(54)
17
Total financial liabilities
757
722
The contingent consideration will be at minimum 0 and at maximum GBP 70,000.
The Group’s best estimate on December 31, 2022, is that the contingent consideration will be
paid in 2024. The previous estimate made on December 31, 2021, was that the contingent
consideration would be paid in 2023. The fair value of the contingent consideration is estimated
based on management assessment when a clinical study utilizing the relevant technology is
initiated in Europe or the U.S resulting in a milestone payment under the share purchase
agreement. The estimated future cash flow is discounted using a market interest rate.
As of December 31, 2021, the maturity profile of our investments in interest funds had maturities
of less than one year. The fair value of the securities was based on quotes received from the
counterparty managing the funds.
The Group sold all its investments in interest funds during
the year 2022 – see further in the Cash Flow Statement.
Note 21
Long-term loan
On July 18, 2022, the Company entered into a $70.0 million funding agreement with NovaQuest.
The funding was accounted for as liability classified debt as the Company has an unavoidable
obligation to settle the funding in cash. The debt is accounted for at amortized cost.
The net proceeds from the funding were $69.2 million after the deduction of transaction costs.
The transaction costs were capitalized and offset against the carrying value of the debt and will
be amortized over the term of the debt.
The debt is secured by certain of the Company’s intellectual property and assets.
Under the terms of the debt, the Company will make quarterly mid-single-digit royalty percentage
payments to NovaQuest on future worldwide annual net sales of imlifidase, commencing upon
approval of imlifidase in the U.S. in kidney transplantation or anti-GBM. In addition, Hansa will
make certain milestone payments to NovaQuest upon U.S. approval of imlifidase in kidney
transplantation or anti-GBM. Total payments by Hansa to NovaQuest are capped at $140
million. The agreement also provides for time-based catch-up payments within the payment cap
if specified payment amounts have not been received by NovaQuest by specified dates, with the
last potential catch-up payment due on December 31, 2028.
The Company will record the difference between the principal and the total payments as interest
expense over the forecasted term of the debt by applying the effective-interest-rate method.
Based on the actual repayment pattern, the Company will recalculate the effective interest each
reporting period until the debt is satisfied.
On 31 December 2022, the loan amounted to SEK 762.6 million, thereof SEK 41.2 million in
accrued interest.
Note 22
Finance Income and Expenses
Years Ended December 31,
(in thousands of SEK)
2022
2021
Interest income on bank deposits measured at amortized cost
8,833
67
Net exchange rate variances
18,415
Finance income
27,248
67
Interest expense
on long-term loan at amortized cost
(42,470)
Interest expense
s, other
(1,196)
(694)
Changes in the fair value of interest funds during the year
(4,973)
(525)
Finance costs
(48,639)
(1,219)
Net finance costs/income
(21,391)
(1,152)
95
Notes to the Group Financial Statements continued
Note 23
Share capital and number of shares
Years Ended December 31,
Number of shares
2022
2021
Outstanding as of January 1
44,473,452
44,473,452
Effect of conversion of C to A in June
114,666
Effect of conversion of C to A shares in October
7,733
Effect of new share issue in December
7,848,111
Outstanding as of December 31
52,443,962
44,473,452
The Group’s shares have a par value of SEK 1.
Holders of ordinary shares are entitled to dividends which are determined after they become
shareholders. Each ordinary share entitles the holder to one vote per share.
Note 24
Share Premium
The share premium reserve is comprised of the amount received, attributable to shareholders’
equity, in excess of the nominal amount of the shares issued, reduced by any amount allocated
to external expenses directly attributable to the offerings. The share premium reserve can be
distributed.
Note 25
Treasury shares included in equity
Number of Shares
Amount, In thousands of SEK
2022
2021
2022
2021
As of January 1,
1,861,909
1,421,457
1,862
1,421
Additions
850,769
440,452
851
440
Exercise of share rights
(122,399)
(122)
As of December 31,
2,590,279
1,861,909
2,590
1,862
Treasury shares have a par value of SEK 1.
The year 2022 additions of Class C shares result from the new issue and subsequent
repurchase of Class C shares related to the funding of the long-term incentive plan (LTIP) 2022,
as approved at the 2022 AGM. Class C shares correspond to treasury shares held by the
Company and are reserved to fund the respective LTIP programs. Each Class C share entitles
the holder to 0.1 vote per share.
Note 26
Reserves
Treasury share reserve
The treasury share reserve comprises own shares repurchased by the Group. Please refer to
Note 14 related to the Group’s LTIP programs and respective vesting dates.
Translation reserve
The translation reserve comprises all foreign exchange differences arising on translation of
financial statements from foreign business prepared in currency other than the reporting
currency for the financial statements of the Group. The Group presents their financial
statements in Swedish Kronor.
Note 27
Royalty Agreements
Royalty agreement with researchers
The Company is a party to two separate royalty agreements (the “Royalty Agreements”) with
certain researchers and an affiliated entity (collectively, the “Counterparties”) of certain patents
related to methods of use of imlifidase. Under each agreement, in consideration of the assignment
of these patents, the Counterparties are entitled to receive a low single-digit royalty percentage
of the Company’s net income related to the utilization of the patents, in each case as defined in
the applicable agreement, and a low-teens percentage of any once-only considerations,
milestones, royalties, license income, consideration for transfer of patents, patent applications
and other intellectual property rights and other payments received by the Company related to the
exploitation of rights related to these patents, in each case subject to certain specified reductions.
On April 20, 2021, the Company received a request for arbitration from the Counterparties
claiming they were entitled to 10% of the upfront payment the Company received under its 2020
collaboration agreement with Sarepta as well as entitlement to participate in payments the
Company may receive under the Sarepta agreement in the future.
In the third quarter 2022, the Company and the Counterparties settled the dispute by entering into
an amendment and settlement agreement (the “Agreement”), which covers all compensation
obligations under the Royalty Agreements. Under the Agreement, the Royalty Agreements will
be treated as one agreement with respect to the Researchers' right to consideration entitling the
Counterparties to low single-digit royalties on net sales as well as mid-single-digit participation in
any once-only consideration received by Hansa in respect of imlifidase. The settlement also
includes a one-off settlement payment.
96
Notes to the Group Financial Statements continued
Note 28
Other operating income and expenses
Years Ended December 31,
2022
2021
Total other operating income
Other operating expenses
Foreign currency losses on receivables/liabilities from operating
activities
(12,469)
(7,398)
Other operating expenses
(8,063)
Total other operating expenses
(20,532)
(7,398)
Note 29
Operating expenses by nature
The table below presents an analysis of operating expenses presented in profit or loss in
classification based on the nature of the expenses:
Years Ended December 31,
(in thousands of SEK)
2022
2021
Personnel expenses
(315,924)
(266,611)
Third party expenses
(358,222)
(283,387)
Depreciation and amortization expenses
(9,959)
(8,606)
Other operating expenses
(20,532)
(6,827)
Total operating expenses
(704,637)
(565,431)
Following table summarizes amortization and depreciation expenses from note 4, 5 and 6
above presented by function in profit or loss and other comprehensive income (loss).
Years Ended December 31,
(in thousands of SEK)
2022
2021
Research and development expenses
7,027
5,639
Sales, general and administrative expenses
2,932
2,967
Total
9,959
8,606
Note 30
Supporting information to the cash flows
As of December 31,
(in
thousands of SEK)
2022
2021
Cash and cash equivalents consist of:
Cash and bank deposits
1,496,179
651,342
Total according to statement of financial position
1,496,179
651,342
Total according to cash flow analysis
1,496,179
651,342
Reconciliation of liabilities arising from financing activities:
As of December 31,
(in thousands of SEK)
2022
2021
Opening balance
January 1,
35,379
5,045
Termination of lease agreement
(25)
(308)
New lease agreements
35,499
Payment of lease liabilities
(6,863)
(4,857)
Net present value of long-term loan
687,221
Accrued interest on long
-term loan
41,152
Unrealized currency differences on long
-term loan
34,228
Closing balance December 31,
791,092
35,379
Note 31
Subsequent events
There are no subsequent events to report.
97
The accompanying notes are an integral part of these Consolidated Financial Statements.
As of December 31,
(in thousands of SEK)
Note
2022
2021
LIABILITIES
Non-current liabilities:
Long-term loan
20
762,601
Lease liabilities
4
21,326
28,491
Deferred revenue
13
29,500
47,020
Contingent consideration
17
757
722
Provisions
15
5,192
7,357
Total non-current liabilities
819,376
83,590
Current
liabilities:
Current tax liabilities
604
Liabilities, group companies
6
5,738
3,901
Lease liabilities
4
7,165
6,888
Trade payables
19
62,357
53,240
Other liabilities
12
17,868
13,358
Deferred revenue
13
40,430
24,961
Refund liabilities
8
27,013
Accrued expenses
11
103,270
69,384
Total current liabilities
264,445
171,732
Total liabilities
1,083,821
255,322
TOTAL STOCKHOLDERS’ EQUITY AND LIABILITIES
1,699,620
1,011,270
Parent Company Financial Statements
Statement of financial position
As of December 31,
(in thousands of SEK)
Note
2022
2021
ASSETS
Non-current
assets:
Intangible assets
2
44,718
26,518
Property and equipment
3
8,113
6,432
Right-of-use assets
4
27,723
35,273
Financial assets:
Investment in subsidiaries
5
24,264
5,095
Receivables, group companies
6
2,203
Total financial assets
24,264
7,298
Total non-current assets
104,818
75,521
Current assets:
Inventories
7
973
242
Trade receivables & unbilled revenue
8,13
42,959
9,712
Prepaid expenses and accrued income
9
33,226
20,820
Other receivables
10
31,142
22,381
Short-term investments
19
237,619
Cash and cash equivalents
19,29
1,486,502
644,975
Total current assets
1,594,802
935,749
TOTAL ASSETS
1,699,620
1,011,270
SHAREHOLDERS’ EQUITY AND LIABILITIES
Shareholders’ equity
Restricted shareholders’ equity:
Share capital
22
55,034
46,335
Development cost reserve
25
20,853
Unrestricted shareholders’ equity:
Share premium reserve
23
3,021,541
2,572,925
Treasury share reserve
24,25
(2,590)
(1,862)
Accumulated deficit
(1,882,304)
(1,312,353)
Loss for the year
16
(596,735)
(549,098)
Total shareholders’ equity
615,799
755,948
98
Parent Company Financial Statements
continued
Statement of profit or loss and other comprehensive income (loss)
Years Ended December 31,
(in thousands of SEK)
Note
2022
2021
Revenue
13
154,525
33,878
Cost of revenue
(38,477)
(15,425)
Sales, general and administrative expenses
28
(330,071)
(327,031)
Research and development expenses
28
(340,192)
(231,974)
Other operating expenses
27
(20,532)
(7,395)
Loss from operations
(574,747)
(547,947)
Finance income (expenses)
Finance income
21
27,245
67
Finance expenses
21
(48,629)
(1,218)
Net finance (expenses) income
21
(21,384)
(1,151)
Loss before tax
(596,131)
(549,098)
Income tax expense
(604)
Loss for the year
16
(596,735)
(549,098)
The accompanying notes are an integral part of these Consolidated Financial Statements.
Years Ended December 31,
(in
thousands of SEK)
Note
2022
2021
Loss for the year
(596,735)
(549,098)
Other comprehensive income (loss) for the year
Total comprehensive loss for the year
(596,735)
(549,098)
99
Parent Company Financial Statements
continued
Statement of cash flows
Years Ended December 31,
(in thousands of SEK)
Note
2022
2021
Cash Flows from Operating Activities
Loss for the year
(596,735)
(549,098)
Adjustments to reconcile net loss to net cash
flows:
Depreciation and amortization expenses
11,854
8,418
Capitalized development cost
2
(20,853)
Expenses related to incentive programs
41,566
56,624
Costs related to pension plan
(226)
Accrued interest and unrealized currency differences
33,923
(231)
(530,245)
(484,513)
Changes:
(Increase) decrease of trade receivables & unbilled
revenue
8
(33,247)
(9,602)
(Increase) of other operating assets
(21,897)
(30,083)
Increase (decrease) trade payables
9,117
28,513
Increase of other operating liabilities
65,705
14,895
Total changes
19,678
3,723
Interest (paid) received, net
5,101
(625)
Income taxes paid
Net cash used in operating activities
(505,467)
(481,416)
Cash Flows from Investing Activities
Proceeds from sale of short-term investments
232,644
Acquisition of property and equipment
3
(3,331)
(2,399)
Net cash (used in) from investing activities
229,313
(2,399)
The accompanying notes are an integral part of these Consolidated Financial Statements
Years Ended December 31,
(in thousands of SEK)
Note
2022
2021
Cash Flows from Financing Activities
Proceeds from long-term loan, net of transaction
costs
(1)
728,373
Proceeds from issue of ordinary shares, net of
transaction costs
(2)
396,196
Payment of lease liabilities
4,29
(6,888)
(4,857)
Net cash (used in) from financing activities
1,117,681
(4,857)
Net change in cash and cash equivalents
841,527
(488,672)
Cash and cash equivalents at beginning of year
644,975
1,133,647
Cash and cash equivalents at end of year
29
1,486,502
644,975
(1)
Total long-term loan transaction cost amounted to SEK 8.027k.
(2)
Total share issue cost amounted to SEK 19,754k.
100
Parent Company Financial Statements
continued
Statement of changes in shareholders’ equity
Restricted shareholders’ Equity
Unrestricted shareholders’ Equity
(in thousands of SEK)
Note
Share
Capital
Development
cost
reserve
Share
Premium
reserve
Treasury
share
reserve
Accumulated
deficit
Loss
for the year
Total
shareholders’
Equity
Balance at January 1, 2021
45,895
2,509,458
(1,421)
(890,710)
(421,644)
1,241,578
Statement of profit or loss and other comprehensive income (loss):
Loss for the year
(549,098)
(549,098)
Other comprehensive income (loss) for the year
Total comprehensive loss for the year
(549,098)
(549,098)
Appropriation of loss of the year 2020 carried forward
(421,644)
421,644
Issue of Class-C shares
(1)
440
(440)
Long term incentive program
63,467
63,467
Balance at December 31, 2021
22,23,24,25
46,335
2,572,925
(1,862)
(1,312,353)
(549,098)
755,948
Statement of profit or loss and other comprehensive income (loss):
Loss for the year
(596,735)
(596,735)
Other comprehensive income (loss) for the year
Total comprehensive loss for the year
(596,735)
(596,735)
Appropriation of loss of the year 2021 carried forward
(549,098)
549,098
Capitalization of development cost
20,853
(20,853)
Issue of ordinary shares
(2)
7,848
388,346
396,196
Issue of Class-C shares
(3)
(851)
Exercise of share rights
(122)
122
Long term incentive program
60,391
60,391
Balance at December 31, 2022
22,23,24,25
55,034
20,853
3,021,541
(2,590)
(1,882,304)
(596,735)
615,799
(1)
The year 2021 additions of Class C shares refer to the new issue and subsequent repurchase of Class C shares that have taken place in accordance with the respective long term incentive plan (LTIP) program.
(2)
Total share issue cost amounted to SEK 19,754k.
(3)
The year 2022 additions of Class C shares refer to the new issue and subsequent repurchase of Class C shares that have taken place in accordance with the respective long term incentive plan (LTIP) program.
The accompanying notes are an integral part of these Consolidated Financial Statements.
101
Notes to the Parent Company Financial Statements
Note 1 Accounting policies
Hansa Biopharma AB (the Parent Company) has prepared its annual report in accordance with
the Swedish Annual Accounts Act (SFS 1995:1554) and Recommendation RFR 2 issued by the
Swedish Financial Reporting Board, Reporting for legal entities. The statements issued by the
Swedish Financial Reporting Board applicable to listed companies have also been applied. RFR
2 entails that in the annual report for the legal entity the Parent Company must apply all of IFRS
and the statements adopted by the EU to the extent possible within the scope of the Swedish
Annual Accounts Act, the Securing of Pension Obligations Act, and taking into consideration the
connection between reporting and taxation. The Recommendation sets forth which exceptions
from, and additions to, IFRS are to be made.
Differences between the Group’s and the Parent Company’s accounting principles
The differences between the Group’s and the Parent Company’s accounting principles are set
forth below. The accounting principles set forth below for the Parent Company have been
applied consistently to all periods presented in the Parent Company’s financial statements.
Subsidiaries
Investment in subsidiaries is recognized at cost after deducting for potential impairment. Cost
includes acquisition-related expenses and potential additional purchase considerations. When
there is an indication that investment in subsidiaries is impaired, recoverable amount is
measured. If the recoverable amount is lower than the carrying amount, an impairment is
recognized. Impairment is recognized in the statement of profit or loss.
Presentation and classification
The differences in the Parent Company’s income statement and statement of financial position
as compared with the Group’s statements consist primarily of the reporting of financial income
and expenses, non-current assets and shareholders’ equity.
Note 14 employees and accrued personnel cost and note 30 audit fees includes information for
the Group and the Parent Company as required by the Swedish Annual Accounts Act.
Note 2 Intangible Assets
Internally generated intangible assets
Expenditure on research activities is recognized as an expense in the period in which it is incurred.
An internally
generated intangible asset arising from development (or from the development
phase of an internal project) is recognized if, and only if, all of the following have been
demonstrated in accordance with IAS 38:
>
the technical feasibility of completing the intangible asset so that it will be available for use or
sale;
>
the intention to complete the intangible asset and use or sell it;
>
the ability to use or sell the intangible asset;
>
how the intangible asset will generate probable future economic benefits;
>
the availability of adequate technical, financial and other resources to complete the
development and to use or sell the intangible asset;
>
and the ability to measure reliably the expenditure attributable to the intangible asset during
its development.
The amount initially recognized for internally
generated intangible assets is the sum of the
expenditure incurred from the date when the intangible asset first meets ALL the recognition
criteria listed above. Where no internally
generated intangible asset can be recognized,
development expenditures are recognized in the statement of profit and loss and other
comprehensive income in the period in which they are incurred.
The Company assessed that with respect to Idefirix
®
(imlifidase) and its conditional approval by
EMA in enabling kidney transplantation in highly sensitized patients it does meet all the above
criteria as of Q4-2022. Going forward, the Company will on a quarterly basis re-assess whether
or not it continues to meet all above criteria and continue to capitalize respective cost for as
long as all criteria are met.
For Q4-2022 and the year ending December 31, 2022 the Company capitalized development
cost in the amount of SEK 20.9 million related to performing its Idefirix
®
(imlifidase) EMA post-
approval commitments. Capitalized development cost mainly include fees paid to 3
rd
party
service providers, personnel expenses of Hansa staff and approportionate finance cost.
Due to uncertainties inherent to the development and registration with the relevant healthcare
authorities of imlifidase in any other indications, the Company estimates that the conditions for
capitalization are not yet met and thus does not capitalize any development cost related to such
other indications.
Subsequent to initial recognition, internally
-
generated intangible assets are reported at cost less
accumulated amortization and accumulated impairment losses, on the same basis as intangible
assets that are acquired separately. If circumstances or changes in the Group’s operations
indicate that the carrying amount of non-current assets in a cash-generating unit may not be
recoverable, management reviews the asset for impairment. An annual impairment test is also
performed for assets yet to be brought into use, i.e. per December 31, 2022 in-process
development projects (see below) and capitalized development cost relating to imlifidase.
Capitalized internal development expenditures for imlifidase’s previous production process were
completely amortized during the year 2018 and written-off in 2022.
102
Notes to the Parent Company Financial Statements
continued
Acquired intangible assets
Patents
The HBP-assay patent cost is amortized over the finite useful life of the underlying patent in the
amount of SEK 559 k for the year 2022 (2021: SEK 559 k). The patent cost is amortized over
sales, general and administration line item in the consolidated statement of profit or loss and
other comprehensive income.
HBP-assay is a method of analysis used to predict severe sepsis in emergency clinics. A first version
has been launched, primarily intended for research purposes and interested specialists. The HBP-
assay has been licensed to a cooperating partner, Axis-Shield Diagnostics Ltd. (Axis-Shield), which is
currently developing a fully commercial product. The Company receives milestone compensation and
additional royalty revenue upon the sale of the sublicensed technology.
In-process development projects
Certain projects pending in the Group are a combination of acquired development projects and
continued activities in these projects. Of the total acquisition cost for acquired in-process
development projects, approximately 75% relates to imlifidase and 25% relates to HBP-assay.
The acquired intangible asset relating to imlifidase presented as in-process development
projects will be amortized over the estimated useful life of the underlying asset. Following the
first commercial sale of imlifidase in Q1-2021 the Group started to amortize the SEK 25,136 k
from the period of first sale in Q1-2021. The estimated useful life is 12 years.
Acquired in-process development projects are assessed for possible impairment at least on an
annual basis and the impairment assessment on December 31, 2022, and 2021 demonstrated
that there was no need for impairment. The estimated recoverable amount supported by
external and internal valuation reports by far exceeds the assets’ carrying amount, resulting in
no impairment charges for the year 2022 and 2021.
Internally generated
Acquired intangible assets
(in thousands of SEK)
Capitalized
development
expenditures
Patents
In-process
development
projects
Total Intangible
Assets
Cost:
Opening balance January 1, 2022
4,485
8,504
25,136
38,125
Write-off
(4,485)
(4,485)
Internally developed
20,853
20,853
Closing balance December 31, 2022
20,853
8,504
25,136
54,493
Amortization:
Opening balance January 1, 2022
(4,485)
(5,028)
(2,094)
(11,607)
Write-off
4,485
4,485
Amortization for the year
(559)
(2,094)
(2,653)
Closing balance December 31, 2022
(5,587)
(4,188)
(9,775)
Carrying amounts:
At January 1, 2022
3,476
23,042
26,518
At December 31, 202
2
20,853
2,917
20,948
44,718
Internally generated
Acquired intangible assets
(in thousands of SEK)
Capitalized
development
expenditures
Patents
In-process
development
projects
Total Intangible
Assets
Cost:
Opening balance January 1, 2021
4,485
8,504
25,136
38,125
Closing balance December 31, 2021
4,485
8,504
25,136
38,125
Amortization:
Opening balance January 1, 2021
(4,485)
(4,469)
(8,954)
Amortization for the year
(559)
(2,094)
(2,653)
Closing balance December 31, 2021
(4,485)
(5,028)
(2,094)
(11,607)
Carrying amounts:
At January 1, 2021
4,035
25,136
29,171
At December 31, 2021
3,476
23,042
26,518
103
Notes to the Parent Company Financial Statements
continued
Note 3
Property and equipment
The property and equipment held by the Parent Company is the same as for the Group, see
note 5 for the Group.
Note 4
Right-of-use assets, lease liabilities
The right-of-use assets held by the Parent Company is the same as for the Group, see note 6
for the Group.
Note 5
Investment in subsidiaries
As of December 31,
(in thousands of SEK)
2022
2021
Opening balance January 1,
5,095
5,095
Shareholder contribution to Hansa Biopharma Inc.*
12,882
Shareholders contribution to Hansa Biopharma Ltd.*
6,286
Paid in capital of Hansa Biopharma Pty Ltd
(amounted to AUD 1)
0
Closing balance December 31,
24,264
5,095
*The shareholders contribution relates to push down of the LTIP expenses for the year 2018 to 2022 from the parent
company to the subsidiaries and the subsequent conversion to equity.
As of December 31,
(in thousands of SEK, except for number of
shares and share percentage)
Number of shares
Share
%
2022
2021
Cartela R & D AB/556746-0083/Lund
1,000
100
2,630
2,630
Hansa Biopharma Ltd / 08361712 /
Cheltenham, United Kingdom
100,000
100
8,742
2,456
Hansa Biopharma Inc, 6846164, Delaware,
USA
1,000
100
12,891
9
Hansa Biopharma Australia Pty Ltd*
1
100
Closing balance December 31,
24,264
5,095
*Dormant Company
Note 6
Intercompany balances
Receivables, group companies
Non-current assets
As of December 31,
(in thousands of SEK)
2022
2021
Opening balance January 1,
2,203
1,972
Change in receivables, net*
(2,203)
231
Closing balance December 31,
2,203
*Converted to equity
Liabilities, group companies
Current liabilities
As of December 31,
(in thousands of SEK)
2022
2021
Opening balance January 1,
3,901
1,613
Change in liabilities, net*
1,837
2,288
Closing balance December 31,
5,738
3,901
*Increase due to increased intercompany services received.
Note 7
Inventories
The Inventories held by the Parent Company is the same as for the Group, see note 7 for the
Group.
Note 8
Trade Receivables, unbilled revenue & refund liabilities
The Trade receivables, unbilled revenue and refund liabilities held by the Parent Company are
the same as for the Group, see note 8 for the Group.
104
Notes to the Parent Company Financial Statements
continued
Note 9
Prepaid expenses and accrued income
As of December 31,
(in thousands of SEK)
2022
2021
Insurances
1,137
829
Healthcare conferences
2,604
124
Software
1,777
1,177
Pension
1,770
1,644
Rent
2,385
2,512
Legal expenses
9,989
8,325
Licence fees
3,857
230
R&D expenses
7,587
3,769
Other
2,120
2,211
Total
33,226
20,820
Note 10
Other receivables
As of December 31,
(in thousands of SEK)
2022
2021
VAT receivables
21,006
9,670
Advance payments to suppliers
9,262
11,292
Other receivables
874
1,419
Total
31,142
22,381
Note 11
Accrued Expenses
As of December 31,
(in thousands of SEK)
2022
2021
Annual leave accrual
17,459
15,376
Accrued social security contribution on salaries
5,243
4,395
Accrued short term incentives, incl. related social security contributions
28,652
21,713
R&D project costs
26,701
7,791
License fees
5,500
Consulting fees
16,664
17,600
Other
3,050
2,509
Closing balance December 31
103,270
69,384
Note 12
Other liabilities / Current
As of December 31,
(in thousands of SEK)
2022
2021
Personnel related liabilities
17,868
13,358
Closing balance December 31
17,868
13,358
Note 13
Revenue
The revenue generated by the Parent Company is the same as for the Group, see note 13 for
the Group.
Note 14
Employees and accrued personnel cost
2022 Guidelines for remuneration to senior executives
The 2022 guidelines proposed by the Board of Directors entail that executive management is
offered a remuneration which is competitive and on market terms. The level of the
remuneration for the individual manager shall be based on factors such as position, expertise,
experience, and performance. The remuneration consists of a fixed salary and pension benefits
and, in addition, may consist of variable salary, share based long-term incentive programs,
severance remuneration and non-monetary benefits. The variable salary is based on the
achievement of quantitative and qualitative targets and should not exceed 75 percent of the
annual fixed salary. Salary during the notice of termination period and severance remuneration
can be a maximum amount of 18 months salaries.
Please refer to the Governance section in this Annual Report 2022 or visit the Company’s
website at www.hansabiopharma.com for information on the 2022 guidelines for remuneration
to senior executives.
Total personnel expenses recorded in the Parent Company are presented below in different
break-downs:
Parent Company 2022
Total personnel expenses recorded in the Parent Company broken down to senior
management and other employees
(in thousands of SEK)
Senior
management
Other employees
Total
Parent Company
Salaries, bonuses and other benefits
36,927
129,428
166,354
Social security contribution
11,423
23,008
34,431
Pension cost, contribution plan
2,812
20,550
23,362
Share-based compensation
32,844
20,121
52,965
Total personnel expenses
84,005
193,107
277,113
105
Notes to the Parent Company Financial Statements
continued
Personnel expenses recorded in the Parent Company related to Senior management
(in thousands of SEK)
Base
salary /
Directors’
fees
Variable
compen
-
sation
Total
Salaries,
bonuses
and other
benefits
Social
security
contri-
butions
Pension
cost
Share-
based
compen-
sation
Total
Chairman of the Board
of Directors
Ulf Wiinberg**
471
471
148
619
Chairman of the Board
of Directors
Peter Nicklin***
479
479
46
525
Director
Anders Gersel
Pedersen
350
350
36
386
Director
Andreas Eggert
440
440
138
578
Director
Eva Nilsagård
450
450
141
591
Director
Hilary Malone
531
531
167
698
Director
Mats Blom
375
375
118
493
CEO
Søren Tulstrup
*7,586
4,024
11,610
3,648
11,223
26,481
Other senior executives
(5 persons)
15,435
6,786
22,221
6,982
2,812
21,622
53,635
Total
26,117
10,810
36,927
11,423
2,812
32,844
84,005
*
Includes 1,694
KSEK, representing 30% of base salary, intended for own pension contribution
**
Chairman of the board until AGM 2022.
*** Chairman of the board from AGM 2022.
Parent Company 2021
Total personnel expenses recorded in Parent Company broken down to senior
management and other employees
(in thousands of SEK)
Senior
management
Other employees
Total
Parent Company
Salaries, bonuses, and other benefits
32,282
103,374
135,656
Social security contribution
10,040
19,302
29,342
Pension cost, contribution plan
2 723
14,835
17,557
Share-based compensation
33,860
22,764
56,624
Total personnel expenses
78,905
160,274
239,180
Personnel expenses recorded in the Parent Company related to Senior management
(in
thousands of
SEK)
Base
salary /
Directors’
fees
Variable
compen-
sation
Other
benefits
Total
Salaries,
bonuses
and other
benefits
Social
security
contri-
butions
Pension
cost
Share-
based
compen-
sation
(in
thousand
s of SEK)
Chairman of the
Board of
Directors
Ulf Wiinberg
946
946
297
1,243
Director
Birgit Stattin
-
Norinder**
134
134
14
147
Director
Anders Gersel
-
Pedersen
352
352
36
388
Director
Andreas Eggert
415
415
130
545
Director Eva
Nilsagård
425
425
133
558
Director
Hilary Malone***
319
319
100
420
Director
Mats Blom
364
364
114
478
CEO
Søren Tulstrup
*7,010
3,444
128
10,582
3,325
12,049
25,955
Other senior
executives
(5 persons)**
12,877
5,579
291
18,746
5,890
2,723
21,811
49,171
Total
22,840
9,023
419
32,282
10,040
2,723
33,860
78,905
*
Includes 1,619
KSEK, representing 30% of base salary, intended for own pension contribution
**
Board member until AGM 2021.
*** Board member from AGM 2021.
106
Notes to the Parent Company Financial Statements
continued
Average number of employees
2022
2021
Number
Of which
are men
Number
Of which
are men
Total Group
144
37%
116
40%
Parent Company
Sweden
135
37%
109
40%
Subsidiaries
UK
4
75%
4
75%
US
5
25%
3
25%
Total subsidiaries
9
7
Breakdown of senior management according to gender
Share of women
2022
2021
Total Group
Board of Directors
33%
33%
Other senior management
17%
17%
Parent Company
Board of Directors
33%
33%
Other senior management
17%
17%
Benefits to senior executives
Senior management of the Company includes the Board of Directors, the CEO and the other
members of the executive management.
Remuneration to Board of Directors
Fees are payable to the chairman of the Board of Directors and other directors pursuant to a
resolution adopted by the annual general meeting (“AGM”). The 2022 AGM resolved that fees
paid to directors for work during 2022 will be SEK 900,000 to the chair of the Board of Directors
and SEK 300,000 to each of the other directors, SEK 150,000 to the chair and SEK 75,000
each to the other directors who are members of the Audit Committee, SEK 40,000 to the chair
and SEK 25,000 each to other directors who are members of the Remuneration Committee,
USD 20,000 to the chair of the U.S. committee and SEK 25,000 each to directors who are
members of the Scientific Committee. There are no contracts regarding severance
compensation or other benefits for the chair of the Board of Directors or other directors.
Salaries and other remuneration to the CEO
Salaries, bonuses, and other benefits
Please refer to the Company’s Remuneration Report elsewhere in this 2022 Annual Report for
further information on the CEOs compensation.
Notice of termination periods and severance compensation
If notice of termination of employment is made by the Company, the notice period may not
exceed six months. Fixed cash salary during the period of notice and any severance pay may
together not exceed an amount equivalent to the fixed cash salary for 18 months for the CEO,
i.e., 6 plus 12 months.
Pension contributions
The CEO is responsible for his pension provision, thus the Company has no direct pension cost
for the CEO.
Salaries and other remuneration to other members of executive management
Salaries and other remuneration to the other members of the executive management is
determined by the CEO and approved by the chair of the Board of Directors. In 2022, executive
management comprised of six people including the CEO.
Notice period of termination and severance payments
Fixed cash salary during the period of notice and any severance pay may together not exceed
an amount equivalent to the fixed cash salary for 6 months, and in exceptional cases, 12
months for the other members of the executive management. When termination is made by the
executive officer the period of notice may not exceed six months.
During their notice period, other members of executive management are entitled to full salary
and other employment benefits.
Pension contributions
Hansa provides pension contributions and benefits in accordance with local statutory
requirements and in accordance with the Company’s insurance and pension policy.
Share-based compensation
The share-based compensation recorded and presented by the Parent Company amounted to
SEK 52,965 and SEK 56,624k for the years ended on December 31, 2022 and 2021,
respectively.
The total amount of LTIP expenses pushed down from the parent company to the
subsidiaries at year end 2022, that relates to the years 2018 to 2021, amounted to SEK
11,399k, resulting in net amount of SEK 41,566k as presented in the Parent Company´s Cash
Flow Statement for the year ended December 31, 2022.
Please refer to Note 14 for the Group
for further information on Hansa’s LTIP programs.
107
Notes to the Parent Company Financial Statements
continued
Note 15
Provisions
The provisions recorded by the Parent Company is the same as for the Group, see note 15 for
the Group.
Note 16
Income Taxes
Unrecognized deferred tax assets
Deferred tax assets have not been recognized regarding temporary differences and losses
carried forward since it is not probable that such can be set off against taxable profits in the
foreseeable future.
The Parent Company’s losses carried forward in 2022 amounted to SEK 2,361,668,000 (2021:
SEK 1,855,284,000). The losses carried forward are, in all material respects, attributable to
Swedish companies and therefore have no due date. A reconciliation of Hansa’s effective tax
rate relative to the Swedish statutory tax rate is as follows:
2022
2021
%
(in thousands of
SEK)
%
(in thousands of
SEK)
Result before tax
(596,131)
(549,098)
Tax according to current tax rate
20.6
122,803
20.6
113,114
Non-deductible expenses
(3.1)
(18,488)
(2.4)
(13,099)
Increase in loss carry forwards without
corresponding capitalization of deferred tax
(17.6)
(104,919)
(18.2)
(100,015)
Reported effective tax
(0.1)
(604)
The corporate tax rate in Sweden is 20.6%, from January 1, 2021.
Note 17
Contingent Consideration
The Contingent consideration recorded by the Parent Company is the same as for the Group,
see note 18 for the Group.
Note 18
Capital Management
The Capital management of the Parent Company is the same as for the Group, see note 19 for
the Group.
Note 19
Financial Risk and Financial Instruments
The Parent Company has exposure to the same financial risks arising from financial instruments
as the Group, see note 20 for the Group.
Carrying amounts of financial assets and financial liabilities
The table below shows the carrying amounts for financial assets and financial liabilities broken
down by measurement categories under IFRS 9 in the Parent Company.
Financial assets valued
at amortized cost
Financial assets valued at fair value
through the income statement
(in thousands of SEK)
2022
2021
2022
2021
Financial assets:
Short term investments
237,619
Receivables, group companies
2,203
Trade receivables
8,360
9,712
Other receivables
874
1,419
Cash and cash equivalents
1,486,502
644,975
Total financial assets
1,495,735
658,309
237,619
Financial liabilities valued
at amortized cost
Financial liabilities valued
at fair value through the consolidated
statement of profit or loss and other
comprehensive income
(in thousands of SEK)
2022
2021
2022
2021
Financial liabilities:
Long-term loan
762,601
Contingent consideration
757
722
Liabilities, group companies
5,738
3,901
Trade payables
62,357
53,240
Accrued expenses (see note 11)
51,915
27,900
Total financial liabilities
882,611
85,041
757
722
Note 20
Long-term Loan
The long-term loan stated by the Parent Company is the same as for the Group, see note 21 for
the Group.
108
Notes to the Parent Company Financial Statements
continued
Note 21
Finance Income and Expenses
Years Ended December 31,
(in thousands of SEK)
2022
2021
Interest income
8,829
67
Changes in the fair value of interest funds during the year
Net exchange rate variances
18,416
Finance income
27,245
67
Interest expense on long-term loan at amortized cost
(42,470)
Interest expenses, other
(1,186)
(693)
Changes in the fair value of interest funds during the year
(4,973)
(525)
Finance costs
(48,629)
(1,218)
Net finance costs/income
(21,384)
(1,151)
Note 22
Share capital and number of shares
The Share Capital stated and number of shares for the Parent Company is the same as for the
Group, see note 23 for the Group.
Note 23
Share Premium
The Share Premium stated by the Parent Company is the same as for the Group, see note 24
for the Group.
Note 24
Treasury shares included in equity
The Treasury shares included in equity stated by the Parent Company is the same as for the
Group, see note 25 for the Group.
Note 25
Reserves
Treasury share reserve
The treasury share reserve represents own shares repurchased by the Group.
Please refer to
Note 14 related to the Group’s LTIP programs and respective vesting dates.
Development cost reserve
The development cost reserve represents the capitalized development cost. Amounts
capitalized in respect of internally generated development expenditure are transferred from
unrestricted equity to development cost reserve in restricted equity. The capitalized amounts
are amortized over their useful lives, reducing the reserve accordingly.
Please refer to Note 2
for further information on the capitalized development cost.
Note 26
Royalty Agreements
The Parent Company is party to the same royalty agreements as the Group, see note 27 for the
Group.
Note 27
Other operating income and expenses
Years Ended December 31,
(in thousands of SEK)
2022
2021
Total other operating
income
Other operating expenses
Foreign currency losses on receivables/liabilities from operating
activities
(12,469)
(7,395)
Other operating expenses
(8,063)
Total other operating expenses
(20,532
)
(7,395)
Note 28
Operating expenses by nature
The table below presents an analysis of operating expenses presented in profit or loss in
classification based on the nature of the expenses:
Years Ended December 31,
(in thousands of SEK)
2022
2021
Personnel expenses
(303,746)
(245,189)
Third party expenses
(356,757)
(305,969)
Depreciation and amortization expenses
(9,760)
(8,418)
Other operating expenses
(20,533)
(6,824)
Total
operating expenses
(690,796)
(566,400)
Following table summarizes amortization and depreciation expenses from note 2, 3 and 4
above presented by function in profit or loss and other comprehensive income (loss).
Years Ended December 31,
(in thousands of SEK)
2022
2021
Research and development expenses
7,027
5,516
Sales, general and administrative expenses
2,733
2,902
Total
9,760
8,418
Note 29
Supporting information to the cash flows
As of December 31,
(in thousands of SEK)
2022
2021
Cash and cash equivalent
s consist of:
Cash and bank deposits
1,486,502
644,975
Total according to the statement of financial position
1,486,502
644,975
Total according to the cash flow
1,486,502
644,975
109
Notes to the Parent Company Financial Statements
continued
Reconciliation of liabilities arising from financing activities:
(in thousands of SEK)
2022
2021
Opening balance January 1,
35,379
5,045
Termination of lease agreement
(25)
(308)
New lease agreements
35,499
Payment of lease liabilities
(6,863)
(4,857)
Net present value of long-term loan
687,221
Accrued interest on long-term loan
41,152
Unrealized currency differences on long-term loan
34,228
Closing balance December 31,
791,092
35,379
Note 30
Audit fees – Group and Parent Company
Years Ended December 31,
(in thousands of SEK)
2022
2021
Group
KPMG AB:
Auditing services
2,565
9,892*
Other services closely related to audit services
385
300
Tax services
Wilkins Kennedy Audit Services
Auditing services
110
68
Parent Company
KPMG AB:
Auditing services
2,565
9,842
Other services closely related to audit services
385
300
Tax services
*Thereof PCAOB Audit services related to the preparation for Dual listing on NASDAQ, USA, in 2021
amounts to 8,832.
Note 31
Collateral provided, contingent liabilities and contingent assets
Nothing to report related to the financial year 2022 and 2021.
Note 32
Related party transactions
Subsidiaries
Interest in subsidiaries and intercompany receivables and liabilities are set out in Note 6.
Transactions with key persons in a senior management position
Transactions with key persons in a senior management position are set forth in Note 14.
Note 33
Information regarding the Parent Company
Hansa Biopharma AB (publ) is a Swedish registered public company (Company reg. no.
556734-5359).
The registered office is located in Lund. The Parent Company’s shares are registered on
NASDAQ Stockholm. The address of the headquarters is Scheelevägen 22, 223 63 Lund.
The consolidated accounts for 2022 and 2021 cover the Parent Company and its subsidiaries,
jointly referred to as the Group.
Note 34
Appropriation of loss carried forward
Unrestricted shareholders’ equity in the Parent Company:
As of December 31,
(in SEK)
2022
2021
Share premium reserve
3,021,541,484
2,572,925,209
Treasury shares
(2,590,279)
(1,861,909)
Loss carried forward
(1,882,303,903)
(1,312,352,987)
Loss for the year
(596,735,718)
(549,097,916)
Total
539,911,584
709,612,397
The Board of Directors proposes that the loss carried forward and unrestricted reserves
to be allocated as follows:
As of December 31,
(in SEK)
2022
2021
Share premium reserve
3,021,541,484
2,572,925,209
Treasury shares
(2,590,279)
(1,861,909)
Loss carried forward
(2,479,039,621)
(1,861,450,903)
Total
539,911,584
709,612,397
Note 35
Subsequent events
The subsequent events for the Parent Company are the same as for the Group, see note 31 for
the Group.
110
Definitions
Equity ratio
Shareholders’ equity as percentage of total statement of financial position assets at the end of
the period.
Shareholders’ equity per share
Shareholders’ equity in relation to number of outstanding shares at the end of the period.
Legal disclaimer
This financial report includes statements that are forward looking, and actual future results may
differ materially from those stated. In addition to the factors discussed, among other factors that
may affect results are development within research programs, including development in
preclinical and clinical trials, the impact of competing research programs, the effect of economic
conditions, the effectiveness of the Company’s intellectual property rights and preclusions of
potential second party’s intellectual property rights, technological development, exchange rate
and interest rate fluctuations and political risks.
The Board of Directors and the CEO affirm that the consolidated financial statements have
been prepared in accordance with International Financial Reporting Standards (IFRS) as
adopted by the EU and give a fair view of the Group’s financial position and results. The
annual report has been prepared in accordance with generally accepted accounting
principles for the Group and the Parent Company and gives a fair overview of the
development of the Group’s and the Parent Company’s operations, financial positions and
results, and describes material risks and uncertainties facing the Parent Company and the
companies included in the Group.
Lund 29 March 2023
Peter Nicklin
Chairman of the Board
Hilary Malone
Director
Mats Blom
Director
Andreas Eggert
Director
Eva Nilsagård
Director
Anders Gersel Pedersen
Director
Søren Tulstrup
CEO and Executive President
The Board of Directors and CEO approved the annual report for publication on
29 March 2023. The consolidated income statement, report on comprehensive income and
statement of financial position as well as the Parent Company’s income statement, report on
comprehensive income and statement of financial position will be subject to adoption at the
annual general meeting to be held on 14 June 2023.
Our auditors’ report was submitted on 30 March 2023.
KPMG AB
Stefan Lundberg
Authorized Public Accountant
Signatures
Hansa Biopharma Annual Report 2022
111
Overview
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Governance
Remuneration
Financials
To the general meeting of the shareholders of Hansa Biopharma AB, corp. id 556734-5359
Report on the annual accounts and consolidated accounts
Opinions
We have audited the annual accounts and consolidated accounts of Hansa Biopharma AB for
the year 2022. The annual accounts and consolidated accounts of the company are included
on pages
[52-112]
in this document.
In our opinion, the annual accounts have been prepared in accordance with the Annual
Accounts Act, and present fairly, in all material respects, the financial position of the parent
company as of 31 December 2022 and its financial performance and cash flow for the year
then ended in accordance with the Annual Accounts Act. The consolidated accounts have
been prepared in accordance with the Annual Accounts Act and present fairly, in all material
respects, the financial position of the group as of 31 December 2022 and their financial
performance and cash flow for the year then ended in accordance with International Financial
Reporting Standards (IFRS), as adopted by the EU, and the Annual Accounts Act. The
statutory administration report is consistent with the other parts of the annual accounts and
consolidated accounts.
We therefore recommend that the general meeting of shareholders adopts the income
statement and balance sheet for the parent company and the statement of comprehensive
income and statement of financial position for the group.
Our opinions in this report on the the annual accounts and consolidated accounts are
consistent with the content of the additional report that has been submitted to the parent
company’s audit committee in accordance with the Audit Regulation (537/2014) Article 11.
Basis for Opinions
We conducted our audit in accordance with International Standards on Auditing (ISA) and
generally accepted auditing standards in Sweden. Our responsibilities under those standards
are further described in the Auditor’s Responsibilities section. We are independent of the
parent company and the group in accordance with professional ethics for accountants in
Sweden and have otherwise fulfilled our ethical responsibilities in accordance with these
requirements.This includes that, based on the best of our knowledge and belief, no prohibited
services referred to in the Audit Regulation (537/2014) Article 5.1 have been provided to the
audited company or, where applicable, its parent company or its controlled companies within
the EU.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a
basis for our opinions.
Key Audit Matters
Key audit matters of the audit are those matters that, in our professional judgment, were of
most significance in our audit of the annual accounts and consolidated accounts of the
current period. These matters were addressed in the context of our audit of, and in forming
our opinion thereon, the annual accounts and consolidated accounts as a whole, but we do
not provide a separate opinion on these matters.
Revenue
See disclosure 13 and accounting principles on page/pages 67-68 in the annual account and
consolidated accounts for detailed information and description of the matter..
Description of key audit matter
Response in the audit
During 2022, the Company recognize
contract revenue in the amount of SEK 26.8
million related to its agreement with Sarepta
Therapeutics Ltd. This relates to an upfront
payment of USD 10 million received in July
2020. The revenue from the upfront
payment is recognized over the period
when the Company fulfils its performance
obligation under the agreement.
The assessment of performance obligations
and allocation of the upfront payment
requires significant knowledge and detailed
review of the contract terms and accounting
standards.
The Company has prepared a budget of
total estimated hours expected to be used
for the fulfillment of the obligation. The hours
spent up to each reporting date is then used
to measure progress. The estimation of the
hours needed to fulfil the obligation requires
management’s judgment.
We have reviewed the agreement as to the
terms and the performance obligation
identified by management.
The revenues from Sarepta Therapeutics Ltd.
have also been verified against upfront
payment.
We have performed a retrospective review and
compared management’s estimated hours,
with the actual hours spent up until reporting
date. Furtheremore we have by sample traced
such hours to underlying records.
We have also assessed accounting principles
and the disclosures related to revenue
included in the annual accounts and
consolidated accounts.
Other Information than the annual accounts and consolidated accounts
This document also contains other information than the annual accounts and consolidated
accounts and is found on pages 2-51 and 117-140. The other information comprises also of
the remuneration report which we obtained prior to the date of this auditor’s report. The
Board of Directors and the Managing Director are responsible for this other information.
Our opinion on the annual accounts and consolidated accounts does not cover this other
information and we do not express any form of assurance conclusion regarding this other
information.
Auditor’s Report
Translation from the Swedish original
Hansa Biopharma Annual Report 2022
112
Overview
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Governance
Remuneration
Financials
Auditor’s Report
continued
In connection with our audit of the annual accounts and consolidated accounts, our
responsibility is to read the information identified above and consider whether the information
is materially inconsistent with the annual accounts and consolidated accounts. In this
procedure we also take into account our knowledge otherwise obtained in the audit and
assess whether the information otherwise appears to be materially misstated.
If we, based on the work performed concerning this information, conclude that there is a
material misstatement of this other information, we are required to report that fact. We have
nothing to report in this regard.
Responsibilities of the Board of Directors and the Managing Director
The Board of Directors and the Managing Director are responsible for the preparation of the
annual accounts and consolidated accounts and that they give a fair presentation in
accordance with the Annual Accounts Act and, concerning the consolidated accounts, in
accordance with IFRS as adopted by the EU. The Board of Directors and the Managing
Director are also responsible for such internal control as they determine is necessary to
enable the preparation of annual accounts and consolidated accounts that are free from
material misstatement, whether due to fraud or error.
In preparing the annual accounts and consolidated accounts The Board of Directors and the
Managing Director are responsible for the assessment of the company’s and the group’s
ability to continue as a going concern. They disclose, as applicable, matters related to going
concern and using the going concern basis of accounting. The going concern basis of
accounting is however not applied if the Board of Directors and the Managing Director intend
to liquidate the company, to cease operations, or has no realistic alternative but to do so.
The Audit Committee shall, without prejudice to the Board of Director’s responsibilities and
tasks in general, among other things oversee the company’s financial reporting process.
Auditor’s responsibility
Our objectives are to obtain reasonable assurance about whether the annual accounts and
consolidated accounts as a whole are free from material misstatement, whether due to fraud
or error, and to issue an auditor’s report that includes our opinions. Reasonable assurance is
a high level of assurance, but is not a guarantee that an audit conducted in accordance with
ISAs and generally accepted auditing standards in Sweden will always detect a material
misstatement when it exists. Misstatements can arise from fraud or error and are considered
material if, individually or in the aggregate, they could reasonably be expected to influence
the economic decisions of users taken on the basis of these annual accounts and
consolidated accounts.
As part of an audit in accordance with ISAs, we exercise professional judgment and maintain
professional scepticism throughout the audit. We also:
>
Identify and assess the risks of material misstatement of the annual accounts and
consolidated accounts, whether due to fraud or error, design and perform audit
procedures responsive to those risks, and obtain audit evidence that is sufficient and
appropriate to provide a basis for our opinions. The risk of not detecting a material
misstatement resulting from fraud is higher than for one resulting from error, as fraud may
involve collusion, forgery, intentional omissions, misrepresentations, or the override of
internal control.
>
Obtain an understanding of the company’s internal control relevant to our audit in order to
design audit procedures that are appropriate in the circumstances, but not for the purpose
of expressing an opinion on the effectiveness of the company’s internal control.
>
Evaluate the appropriateness of accounting policies used and the reasonableness of
accounting estimates and related disclosures made by the Board of Directors and the
Managing Director.
>
Conclude on the appropriateness of the Board of Directors’ and the Managing Director’s,
use of the going concern basis of accounting in preparing the annual accounts and
consolidated accounts. We also draw a conclusion, based on the audit evidence obtained,
as to whether any material uncertainty exists related to events or conditions that may cast
significant doubt on the company’s and the group’s ability to continue as a going concern.
If we conclude that a material uncertainty exists, we are required to draw attention in our
auditor’s report to the related disclosures in the annual accounts and consolidated
accounts or, if such disclosures are inadequate, to modify our opinion about the annual
accounts and consolidated accounts. Our conclusions are based on the audit evidence
obtained up to the date of our auditor’s report. However, future events or conditions may
cause a company and a group to cease to continue as a going concern.
>
Evaluate the overall presentation, structure and content of the annual accounts and
consolidated accounts, including the disclosures, and whether the annual accounts and
consolidated accounts represent the underlying transactions and events in a manner that
achieves fair presentation.
>
Obtain sufficient and appropriate audit evidence regarding the financial information of the
entities or business activities within the group to express an opinion on the consolidated
accounts. We are responsible for the direction, supervision and performance of the group
audit. We remain solely responsible for our opinions.
>
We must inform the Board of Directors of, among other matters, the planned scope and
timing of the audit. We must also inform of significant audit findings during our audit,
including any significant deficiencies in internal control that we identified.
>
We must also provide the Board of Directors with a statement that we have complied with
relevant ethical requirements regarding independence, and to communicate with them all
relationships and other matters that may reasonably be thought to bear on our
independence, and where applicable, measures that have been taken to eliminate the
threats or related safeguards.
>
From the matters communicated with the Board of Directors, we determine those matters
that were of most significance in the audit of the annual accounts and consolidated
accounts, including the most important assessed risks for material misstatement, and are
therefore the key audit matters. We describe these matters in the auditor’s report unless law
or regulation precludes disclosure about the matter.
Translation from the Swedish original
Hansa Biopharma Annual Report 2022
113
Overview
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Governance
Remuneration
Financials
Auditor’s Report
continued
We must inform the Board of Directors of, among other matters, the planned scope and
timing of the audit. We must also inform of significant audit findings during our audit,
including any significant deficiencies in internal control that we identified.
We must also provide the Board of Directors with a statement that we have complied with
relevant ethical requirements regarding independence, and to communicate with them all
relationships and other matters that may reasonably be thought to bear on our
independence, and where applicable, measures that have been taken to eliminate the threats
or related safeguards.
From the matters communicated with the Board of Directors, we determine those matters
that were of most significance in the audit of the annual accounts and consolidated
accounts, including the most important assessed risks for material misstatement, and are
therefore the key audit matters. We describe these matters in the auditor’s report unless law
or regulation precludes disclosure about the matter.
Report on other legal and regulatory requirements
Auditor’s audit of the administration and the proposed appropriations of
profit or loss
Opinions
In addition to our audit of the annual accounts and consolidated accounts, we have also audited
the administration of the Board of Directors and the Managing Director of Hansa Biopharma AB
for the year 2022 and the proposed appropriations of the company’s profit or loss.
We recommend to the general meeting of shareholders that the profit be appropriated in
accordance with the proposal in the statutory administration report and that the members of the
Board of Directors and the Managing Director be discharged from liability for the financial year.
Basis for Opinions
We conducted the audit in accordance with generally accepted auditing standards in
Sweden. Our responsibilities under those standards are further described in the Auditor’s
Responsibilities section. We are independent of the parent company and the group in
accordance with professional ethics for accountants in Sweden and have otherwise fulfilled
our ethical responsibilities in accordance with these requirements.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a
basis for our opinions.
Responsibilities of the Board of Directors and the Managing Director
The Board of Directors is responsible for the proposal for appropriations of the company’s
profit or loss. At the proposal of a dividend, this includes an assessment of whether the
dividend is justifiable considering the requirements which the company’s and the group’s
type of operations, size and risks place on the size of the parent company’s and the group’s
equity, consolidation requirements, liquidity and position in general.
The Board of Directors is responsible for the company’s organization and the administration of
the company’s affairs. This includes among other things continuous assessment of the
company’s and the group’s financial situation and ensuring that the company’s organization is
designed so that the accounting, management of assets and the company’s financial affairs
otherwise are controlled in a reassuring manner.
The Managing Director shall manage the ongoing administration according to the Board of
Directors’ guidelines and instructions and among other matters take measures that are
necessary to fulfill the company’s accounting in accordance with law and handle the
management of assets in a reassuring manner.
Auditor’s responsibility
Our objective concerning the audit of the administration, and thereby our opinion about
discharge from liability, is to obtain audit evidence to assess with a reasonable degree of
assurance whether any member of the Board of Directors or the Managing Director in any
material respect:
>
has undertaken any action or been guilty of any omission which can give rise to liability to
the company, or
>
in any other way has acted in contravention of the Companies Act, the Annual Accounts Act
or the Articles of Association.
Our objective concerning the audit of the proposed appropriations of the company’s profit or
loss, and thereby our opinion about this, is to assess with reasonable degree of assurance
whether the proposal is in accordance with the Companies Act.
Reasonable assurance is a high level of assurance, but is not a guarantee that an audit
conducted in accordance with generally accepted auditing standards in Sweden will always
detect actions or omissions that can give rise to liability to the company, or that the proposed
appropriations of the company’s profit or loss are not in accordance with the Companies Act.
As part of an audit in accordance with generally accepted auditing standards in Sweden, we
exercise professional judgment and maintain professional scepticism throughout the audit.
The examination of the administration and the proposed appropriations of the company’s
profit or loss is based primarily on the audit of the accounts. Additional audit procedures
performed are based on our professional judgment with starting point in risk and materiality.
This means that we focus the examination on such actions, areas and relationships that are
material for the operations and where deviations and violations would have particular
importance for the company’s situation. We examine and test decisions undertaken, support
for decisions, actions taken and other circumstances that are relevant to our opinion
concerning discharge from liability. As a basis for our opinion on the Board of Directors’
proposed appropriations of the company’s profit or loss we examined whether the proposal is
in accordance with the Companies Act.
Translation from the Swedish original
Hansa Biopharma Annual Report 2022
114
Overview
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Governance
Remuneration
Financials
Auditor’s Report
continued
The auditor’s examination of the Esef report
Opinion
In addition to our audit of the annual accounts and consolidated accounts, we have also
examined that the Board of Directors and the Managing Director have prepared the annual
accounts and consolidated accounts in a format that enables uniform electronic reporting
(the Esef report) pursuant to Chapter 16, Section 4(a) of the Swedish Securities Market
Act (2007:528) for Hansa Biopharma AB for year 2022.
Our examination and our opinion relate only to the statutory requirements.
In our opinion, the Esef report has been prepared in a format that, in all material respects,
enables uniform electronic reporting.
Basis for opinion
We have performed the examination in accordance with FAR’s recommendation RevR 18
Examination of the Esef report. Our responsibility under this recommendation is described in
more detail in the Auditors’ responsibility section. We are independent of Hansa Biopharma
AB in accordance with professional ethics for accountants in Sweden and have otherwise
fulfilled our ethical responsibilities in accordance with these requirements.
We believe that the evidence we have obtained is sufficient and appropriate to provide a
basis for our opinion.
Responsibilities of the Board of Directors and the Managing Director
The Board of Directors and the Managing Director are responsible for the preparation of the
Esef report in accordance with the Chapter 16, Section 4(a) of the Swedish Securities Market
Act (2007:528), and for such internal control that the Board of Directors and the Managing
Director determine is necessary to prepare the Esef report without material misstatements,
whether due to fraud or error.
Auditor’s responsibility
Our responsibility is to obtain reasonable assurance whether the Esef report is in all material
respects prepared in a format that meets the requirements of Chapter 16, Section 4(a) of the
Swedish Securities Market Act (2007:528), based on the procedures performed.
RevR 18 requires us to plan and execute procedures to achieve reasonable assurance that
the Esef report is prepared in a format that meets these requirements.
Reasonable assurance is a high level of assurance, but it is not a guarantee that an
engagement carried out according to RevR 18 and generally accepted auditing standards in
Sweden will always detect a material misstatement when it exists. Misstatements can arise
from fraud or error and are considered material if, individually or in aggregate, they could
reasonably be expected to influence the economic decisions of users taken on the basis of
the Esef report.
The audit firm applies ISQC 1 Quality Control for Firms that Perform Audits and Reviews of
Financial Statements, and other Assurance and Related Services Engagements and
accordingly maintains a comprehensive system of quality control, including documented
policies and procedures regarding compliance with professional ethical requirements,
professional standards and legal and regulatory requirements.
The examination involves obtaining evidence, through various procedures, that the Esef report
has been prepared in a format that enables uniform electronic reporting of the annual
accounts and consolidated accounts. The procedures selected depend on the auditor’s
judgment, including the assessment of the risks of material misstatement in the report,
whether due to fraud or error. In carrying out this risk assessment, and in order to design
procedures that are appropriate in the circumstances, the auditor considers those elements of
internal control that are relevant to the preparation of the Esef report by the Board of Directors
and the Managing Director, but not for the purpose of expressing an opinion on the
effectiveness of those internal controls. The examination also includes an evaluation of the
appropriateness and reasonableness of the assumptions made by the Board of Directors and
the Managing Director.
The procedures mainly include a validation that the Esef report has been prepared in a valid
XHMTL format and a reconciliation of the Esef report with the audited annual accounts and
consolidated accounts.
Furthermore, the procedures also include an assessment of whether the consolidated
statement of financial performance, financial position, changes in equity, cash flow and
disclosures in the Esef report have been marked with iXBRL in accordance with what follows
from the Esef regulation.
KPMG AB, Box 382, 101 27, Stockholm, was appointed auditor of Hansa Biopharma AB by the
general meeting of the shareholders on the 30 June 2022 KPMG AB or auditors operating at
KPMG AB have been the company’s auditor since 2014.
Stockholm, 30 March, 2023
KPMG AB
Stefan Lundberg
Authorized Public Accountant
Translation from the Swedish original
Hansa Biopharma Annual Report 2022
115
Overview
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Governance
Remuneration
Financials
Hansa Biopharma Annual Report 2022
116
Overview
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Remuneration
Governance
Governance
10
117
General principles
121
The Board
129
Internal controls and risk management in
respect of the financial reporting
130
Compliance
131
Executive Remuneration – to be approved
by the 2023 AGM
General principles
The Board of Directors of Hansa Biopharma AB (publ) (the
“Board”), Company reg. no. 556734-5359 (“Hansa” or the
“Company”) hereby submits the 2022 Corporate Governance
Report in accordance with the requirements of the Swedish
Annual Accounts Act (1995:1554) (Sw. årsredovisningslagen)
and the Swedish Corporate Governance Code (the “Code”).
The Company’s corporate governance is mainly regulated by the provisions of the
Company’s articles of association, the Swedish Companies Act (2005:551) (Sw.
aktiebolagslagen) and other Swedish legislation, the Nordic Main Market Rulebook for
Issuers of Shares and the Code.
The Corporate Governance Report has been reviewed by the Company’s auditors in
accordance with the Swedish Annual Accounts Act. It does not constitute a part of the formal
annual report documents.
No infringements of Nasdaq’s rules and no breach of good practice on the securities market
were reported by the stock exchange’s disciplinary committee or the Swedish Securities
Council during the financial year 2022.
During 2022, Hansa deviated from the Code by not announcing the names of the members of
the Nomination Committee at least six months before the Annual General Meeting. The
reason for this deviation is that the members of the Nomination Committee were not fully
confirmed in time.
The Group comprises the Parent Company, Hansa Biopharma AB, and its wholly owned
subsidiaries Cartela R & D AB, Hansa Biopharma Ltd, Hansa Biopharma Inc, and Hansa
Biopharma Australia Pty Ltd.
Shareholders
There are no limitations on the transferability of Hansa Biopharma’s shares due to legal
restrictions or provisions of the articles of association. To Hansa Biopharma’s knowledge,
no agreement has been entered into between any shareholders which might limit the
transferability of the shares. As of 31 December 2022, Redmile Group LLC is the only
shareholder owning more than 10 percent of the Company’s shares, in its shareholdings of
20.8 percent.
Significant external and internal regulations and
policies which affect corporate governance:
Significant internal regulations and policies:
>
Articles of association
>
Instruction for the CEO, including the financial reporting instruction
>
Work procedures for the Board
>
Disclosure policy
>
Insider policy
>
Procurement and expenditure policy
>
Treasury policy
>
Finance policy
>
Risk management policy
>
Staff handbook
>
Executive remuneration policy
>
Code of Conduct
>
Supplier Code
>
Global Data Privacy policy
Significant external regulations:
>
Market Abuse Regulation
>
Swedish Companies Act
>
Swedish Accounting Act
>
Swedish Annual Accounts Act
>
International standards for audits and financial reporting (IFRS)
>
Nordic Main Market Rulebook for Issuers of Shares
>
Swedish Corporate Governance Code
Introduction
Hansa Biopharma Annual Report 2022
117
Governance
Overview
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Remuneration
General principles
continued
Hansa’s corporate governance structure
Overview of Hansa’s corporate governance structure during 2022
Board of Directors
Executive
Committee
External
auditors
Nomination
Committee
Risk
Management
Compliance
General Meeting
Electing / Appointing
Reporting / Informing
Audit
Committee
Remuneration
Committee
Scientific
Committee
U.S.
Committee
Information regarding Hansa Biopharma AB’s shares
The Company’s shares were admitted for trading on Nasdaq Stockholm, Small Cap, in
November 2015. The Company’s shares were previously, since 2007, listed on Nasdaq
First North.
The Company’s shares are divided into ordinary shares and C-shares. On 31 December 2022,
the total number of shares issued was 55,034,241 with 52,443,962 ordinary shares
outstanding and 2,590,279 C-shares, with a quotient value of SEK 1. Each ordinary share
carries one vote, and each C-share carries one tenth. All C-shares are owned by the
Company. Each person entitled to vote may vote for his or her full number of shares.
The number of votes in the Company amounts to 52,702,989.9.
Each ordinary share confers the right to an equally large percentage of the Company’s
distributable profits. The C-shares are not entitled to dividends and are subject to a
redemption and reclassification clause.
General meeting
The Company’s highest decision-making body is the general meeting, where the
shareholders’ influence over the Company is exercised. In addition to what follows from
applicable law regarding shareholders’ right to participate at general meetings, shareholders
who wish to participate at a general meeting, personally or through a proxy, must give notice
of their attendance.
Notices to attend general meetings are given through advertisement as well as on the
Company’s website (www.hansabiopharma.com). The Annual General Meeting (“AGM”) must
be held within six months from the close of the financial year. At the AGM, the shareholders
adopt resolutions regarding, among other things: the Board and auditors; the procedure for
appointing the nomination committee; and discharge from liability for the Board and the CEO
in respect of the preceding year. Resolutions are also adopted regarding adoption of the
annual report; disposition of profits or treatment of losses; fees for the directors and auditors;
and, if applicable, guidelines for remuneration for senior executives.
2022 Annual General Meeting
The 2022 AGM was held on 30 June, with participation through advance voting according to
sections 20 and 22 in the Act on temporary exemptions in order to facilitate the conduction of
general meetings (Sw. lag (2020:198) om tillfälliga undantag för att underlätta genomförandet
av bolags- och föreningsstämmor). In total, 16,427,831 of the shares in the Company were
represented, meaning that 36.7 percent of the total number of votes and 35.45 percent of the
total number of shares in the Company were represented.
The AGM adopted the 2021 annual accounts and granted the directors and CEO a discharge
from liability. The AGM resolved that no dividend would be paid. The AGM resolved that
Anders Gersel Pedersen, Andreas Eggert, Eva Nilsagård, Hilary Malone and Mats Blom are
re-elected as members of the Board, and resolved election of Peter Nicklin as new member of
the Board, all for the period until the end of the next AGM. Ulf Wiinberg, previous chair of the
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General principles
continued
Board until the end of the 2022 AGM, was not standing for re-election. The AGM further
resolved to elect Peter Nicklin as chair of the Board for the period until the end of the next
AGM. The AGM resolved to re-elect KPMG AB as auditor, with Stefan Lundberg as the
auditor in charge, for the period until the end of the next AGM.
The AGM resolved that the fees for the Board, for the period until the end of the next AGM,
should remain unchanged from the previous year and shall be SEK 900,000 to the chair of the
Board and SEK 300,000 each to the other board members. It was further resolved that the
remuneration to the chair of the Audit Committee should be SEK 150,000 and SEK 75,000 to
each other member in the Audit Committee, SEK 40,000 to the chair of the Remuneration
Committee and SEK 25,000 to each other member in the Remuneration Committee, SEK
25,000 to each board member in the Scientific Committee, and USD 20,000 to the chair of
the U.S. Committee. It was further resolved that the remuneration to the auditor shall be paid
as per approved current account.
The AGM further resolved, in accordance with the Board’s proposal, to adopt guidelines for
executive remuneration, to amend the articles of association, adopt a long-term incentive
program based on performance-based share rights for certain employees in Hansa
Biopharma, and adopt a long-term incentive program based on employee stock options for
certain employees in Hansa Biopharma.
It was further resolved, in accordance with the Board’s proposal, to authorize the Board, for the
period up to the next AGM, to adopt decisions, whether on one or several occasions and
whether with or without pre-emptive rights for the shareholders, to issue new ordinary shares,
and warrants and/or convertibles; provided however that such issues, or number of shares
created in connection with conversion of warrants and/or convertibles, in aggregate, may not
correspond to a dilution of more than 20 per cent of the total number of shares outstanding after
full exercise of the authorization. It should also be possible to make such an issue resolution
stipulating payment in cash, in kind payment, the right to offset debt or other conditions. The
purpose of the authorization is to increase the financial flexibility of the Company and the acting
scope of the Board as well as to potentially broaden the shareholder base.
Minutes from the 2022 AGM are available at Hansa Biopharma’s website
(www.hansabiopharma.com). The 2023 AGM will take place on 14 June 2023.
Remuneration to senior executives
The remuneration guidelines for senior executives adopted by the 2022 AGM entail that
senior executives are offered remuneration which is competitive and on market terms. The
level of the remuneration for the individual senior executive shall be based on factors such as
position, expertise, experience and performance. The remuneration consists of a fixed base
salary and pension benefits and, in addition, may consist of a variable cash remuneration
(including STI), share-based long-term incentive programs (LTIP) as resolved by the AGM,
severance remuneration, and other benefits. The variable salary shall be on market terms and
be based on the achievement of quantitative and qualitative targets and should not exceed
75 percent of the annual fixed base salary.
The variable cash remuneration is intended to support recruitment or retention of key
personnel or to reward extraordinary performance beyond the individual’s ordinary
responsibilities and shall not exceed 30 percent of the annual fixed base salary. Contributions
to pension plans shall not exceed 30 percent of the annual fixed base salary. Salary during the
notice of termination period and severance remuneration shall be possible in a total maximum
amount of 18 monthly base salaries.
If notice of termination is made by the Company, the notice period may not exceed six months
and the fixed cash salary during the period of notice and severance pay may together not
exceed an amount equivalent to the fixed cash salary for 18 months for the CEO, and, for
other senior executives, may not exceed an amount equivalent to the fixed cash salary for
6 months, and in exceptional cases, 12 months. When termination is made by the senior
executive, the period of notice may not exceed six months and no severance pay will be paid.
Share and share based long-term incentive programs shall be decided by the AGM. For
information regarding the adopted ongoing long-term incentive programs, please refer to the
Directors Report and Note 2 and Note 14 to the Consolidated Financial Statements elsewhere
in this Annual Report 2022.
The Board of Directors may temporarily resolve to derogate from the executive remuneration
guidelines, in whole or in part, if in a specific case there is special cause for the derogation
and a derogation is necessary to serve the Company’s long-term interests, including its
sustainability, or to ensure the Company’s financial viability.
Please refer to Note 14 to the Financial Statements of the Parent Company and the
Remuneration report in this Annual Report 2022 for further information on the 2022 guidelines.
During 2022, neither the Remuneration Committee nor the Board of Directors received any
comments or questions from shareholders on the remuneration guidelines adopted at the
2022 AGM.
Nomination Committee
Prior to the 2023 AGM, Hansa’s Nomination Committee comprises of Natalie Berner
(representing Redmile Group and chair of the Nomination Committee), Jannis Kitsakis
(representing AP4), and Arne Myhrman (representing Thomas Olausson). Peter Nicklin (chair of
the Board) is the convenor of the Nomination Committee.
Procedures for appointing members of the Nomination Committee were adopted by the
2022 AGM. The Nomination Committee shall, pursuant to the Code, consist of at least three
members of which a majority shall be independent in relation to Hansa Biopharma and its
management. In addition, at least one member of the Nomination Committee shall be
independent in relation to the largest shareholder in terms of voting rights or group of
shareholders who cooperates in terms of Hansa’s management.
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General principles
continued
The Nomination Committee shall prepare proposals for the 2023 AGM for the chair of the
AGM, board members, chair of the Board of Directors, remuneration to the Board, auditors,
remuneration to the auditors, and the principles for the Nomination Committee before the
2023 AGM.
External auditors
The external audit of the accounts of the Parent Company and the Group, as well as of the
management by the Board and the CEO, is carried out in accordance with generally
accepted accounting standards in Sweden. The auditor participates in at least one Board
meeting per year, going through the accounts for the year and leading a discussion with the
directors without the CEO or any other senior executive present.
Pursuant to the articles of association, Hansa must have a registered accounting firm as its
external auditor. The accounting firm KPMG AB has been the auditor of the Company since
the 2014 AGM. As from the 2022 AGM, certified public accountant Stefan Lundberg is auditor
in charge. Stefan Lundberg is a member of the Swedish Institute of Authorized Public
Accountants. For information regarding fees paid to the auditors, please refer to Note 30 to
the Financial Statements.
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Governance
The Board is the highest management body beneath the AGM
The Board
The overall task of the Board is to manage the affairs of the Company in the best possible
manner on behalf of the shareholders. The Board must continuously evaluate the Group’s
operations, development and financial situation, as well as the operative management
including identifying how sustainability issues impact risks to and business opportunities for
the Group. The Board decides upon, among other things: issues concerning the Group’s
strategic focus and organization; business plans; financial plans and budget; significant
agreements; major investments and commitments; and finance, disclosure, and risk
management policies. The Board must also ensure that the Company prepares insider
instructions. The Board works according to written rules of procedure which are adopted
annually, and which regulate the framework for the Board meetings, including the frequency
and agenda of meetings, distribution of materials for meetings, and matters to be presented
to the Board for information or for a decision. The rules of procedure also govern how the
board work is allocated among the Board and its committees. The Board has also adopted
CEO instructions which govern the allocation of work among the Board, the chair of the
Board, and the CEO, and which defines the CEO’s authority.
The Board is elected by the shareholders at the AGM up until the end of the next AGM, with
the possibility of re-election. In addition, the Company’s employees may, pursuant to
statutory rules regarding the representation of employees on the Board, elect employee
representatives to the Board. Currently, the Board has no employee representatives. All
current board members are considered independent under the corporate governance
standards of the Code and Nasdaq Stockholm.
The chair of the Board is responsible for contacts with the shareholders regarding ownership
issues and for communicating the shareholders’ views to the Board of Directors. The chair is
further responsible for the day-to-day contact with the CEO and senior executives and must
keep himself well informed about, and monitor, the Company’s business. The chair is
responsible for ensuring that the Board’s work is carried out efficiently and that the Board
fulfils its obligations in accordance with applicable laws and regulations, the Code, the
articles of association, resolutions of the general meeting, and the Board’s own rules of
procedure, and that the Board carries out the decisions that are made and that their work is
evaluated. Further, the chair is responsible for ensuring that the directors regularly update
their knowledge about the Company and that new directors receive necessary introductory
training. The chair must also approve remuneration and other employment terms and
conditions for senior executives, and is responsible for the Company’s archives, in which
minutes from all Directors’ meetings and general meetings must be saved.
The chair prepares Board meetings together with the CEO and Corporate Secretary. The
notice of the meeting and the agenda are sent to the directors together with sufficient
decision-making documentation. A Board meeting includes a review of the business,
including development and advances within research and development, business
development, consolidated earnings and financial position, financial reports, and forecasts.
Pursuant to the Company’s articles of association, the Board must comprise of not less than
three and not more than ten directors elected by the AGM. The Board is quorate when more
than half of the directors are present. The articles of association do not contain any provisions
regarding appointment or dismissal of directors or regarding amendment of the articles of
association.
Directors’ fees were set at the 2022 AGM for a period up to and including the 2023 AGM. The
fees for the Board’s work in 2022 were set as follows: SEK 900,000 to the chair of the Board
and SEK 300,000 each to the other board members. It was further resolved that the
remuneration to the chair of the Audit Committee should be SEK 150,000 and SEK 75,000 to
each other member in the Audit Committee, SEK 40,000 to the chair of the Remuneration
Committee and SEK 25,000 to each other member in the Remuneration Committee, SEK
25,000 to each board member in the Scientific Committee, and USD 20,000 to the chair of the
U.S. Committee. No remuneration other than the abovementioned fees have been paid to the
Board except for travel cost reimbursements. The board members are not entitled to any
share-based compensation. No pension premiums or similar benefits were paid to directors.
None of the directors are entitled to benefits after completion of their duties. Please see the
Remuneration Report and Note 14 to the Financial Statements, for additional information
regarding employment terms and conditions for the Board and senior executives.
Directors
The Board currently comprises six individuals, including the chair.
The 2022 AGM re-elected Anders Gersel Pedersen, Andreas Eggert, Eva Nilsagård, Mats
Blom, and Hilary Malone as members of the Board. Further, Peter Nicklin was elected as a
new member and chair of the Board. Ulf Wiinberg, previous chair of the Board, was not
standing for re-election. Each director’s term continues until the end of the next AGM. There
are no rules about how long a member may serve on the Board if being re-elected.
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Peter Nicklin
Born 1963
Member and chair of the Board since 2022,
member of the Remuneration Committee, the
Scientific Committee and the US Committee.
Shareholding: 14,500 shares
Peter Nicklin has more than 30 years of extensive
experience and background in the pharmaceutical
and healthcare sector in both developed, as well as
emerging markets and significant experience in
leading global teams. Chair of the Board at Tunstall
Healthcare and Sciensus. Previously, CEO and
member of the Board of Amann Girrbach AG,
Corporate Vice President and EMEA President of
Baxter International (NYSE: BAX), as well as senior
executive roles at Bayer Healthcare (XETRA: BAYN),
Novartis (SWX: NOVN) and Bristol-Myers Squibb
(NYSE:BMY). Peter holds a Bachelor of Arts with
Honours in Finance from Lancaster University. He is
also a Chartered Accountant having qualified at
PriceWaterhouseCoopers in London.
Independent of Hansa and its executive
management.
Independent of major shareholders of Hansa.
Eva Nilsagård
Born 1964
Member of the Board since 2019 and chair of the
Audit Committee.
Shareholding: 3,000 shares
Eva Nilsagård is the founder and Chief Executive
Officer of Nilsagård Consulting AB. Previous interim
Chief Financial Officer of various companies,
including OptiGroup AB, Plastal, and Vitrolife AB
(STO: VITR). She has also served in various senior
positions at the Volvo Group, or Volvo (STO: VOLV),
including Senior Vice President Strategy & Business
Development. Earlier in her career, Eva also held
senior positions in finance and business
development at AstraZeneca plc (LSE: AZN) and
AB SKF (STO: SKF). Board member and chair of the
audit committee of SEK (Swedish Export Credit
Company), AddLife (STO: ALIF), Bufab Group
(STO: BUFAB), Irras AB (STO: IRRAS), Nimbus Group
AB (STO: BOAT), Nanexa (STO: NANEXA),
Ernströmgruppen and Xbrane Biopharma (STO:
XBRANE), the chair of Spermosens AB (Spotlight:
SPERM) and Diagonal Bio AB (STO: DIABIO), and
board member of eEducation Albert AB (STO:
ALBERT). Eva has more than ten years of
experience as a mentor for young female managers
with high potential. She holds an Executive M.B.A.
in Economics and a B.Sc. in accounting and
finance from School of Business, Economics and
Law in Gothenburg.
Independent of Hansa and its executive
management.
Independent of major shareholders of Hansa.
The Board
continued
Prior to the 2022 AGM, the Nomination Committee announced that it had
applied the provisions of rule 4.1 of the Code as Board diversity policy.
The aim is that the Board as a collective should possess the required mix
in terms of background and knowledge, whereby an even gender
distribution is considered. The result of the Nomination Committee’s
application of the diversity policy is a Board that represents a mix of both
professional experience and knowledge as well as geographical and
cultural backgrounds. One third (1/3) of the board members elected by
the AGM are women.
Information about Board members as of 31 December 2022
Holdings in the Company include one’s own holdings as well as those of
closely related persons.
Tenure (years)
5
LONGEST
1
SHORTEST
Gender diversity
33
%
FEMALE
67
%
MALE
Meetings
18
BOARD MEETINGS
99
%
ATTENDANCE
1
2
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Governance
Mats Blom
Born 1965
Member of the Board since 2019 and member of
the Audit Committee.
Shareholding: 1,000 shares
Mats Blom serves as Chief Financial Officer of
NorthSea Therapeutics B.V. Previous Chief Financial
Officer of Modus Therapeutics AB (STO: MODTX),
Zealand Pharma A/S (CSE: ZELA), Swedish Orphan
International AB (acquired by BioVitrum, now Swedish
Orphan Biovitrum AB (publ) (STO:SOBI)), Active
Biotech AB (publ) (STO:ACTI), and Anoto Group AB
(STO: ANOT). Previously also management consultant
at Gemini Consulting and Ernst & Young. Board
member of Egetis Therapeutics AB (STO: EGTX),
Altamira Therapeutics Ltd. (NASDAQ: CYTO), and
Pephexia Therapeutics ApS. Mats holds a B.A. in
Business Administration and Economics from
Lund University and an M.B.A. from the IESE
University of Navarra, Barcelona.
Independent of Hansa and its executive management.
Independent of major shareholders of Hansa.
Andreas Eggert
Born 1967
Member of the Board since 2018, chair of the
Remuneration Committee, and member of the
Audit Committee and the Scientific Committee.
Shareholding: 5,500 shares
Andreas Eggert has over 25 years of cross-functional
leadership experience including commercial
operations, launch and portfolio management, brand
strategy, market access, and strategic consulting.
Chief Operating Officer at X-Vax Technology Inc. in
the U.S. Previously, served as Senior Group Vice
President, Global Product Strategy & Portfolio
Development, and member of the Corporate
Management Committee at H. Lundbeck A/S (CSE:
LUN) in Denmark. Previously, also served in various
senior commercial roles at Wyeth, LLC (acquired by
Pfizer Inc. (NYSE: PFE)) in the U.S., Japan and in
Germany, including as Vice President & Global
Business Manager. Earlier in his career, Andreas also
was a Management Consultant at A.T. Kearney. He
holds an M.B.A. from Azusa Pacific University.
Independent of Hansa and its executive
management.
Independent of major shareholders of Hansa.
Anders Gersel Pedersen
Born 1951
Member of the Board since 2018, chair of the
Scientific Committee, and member of the
Remuneration Committee.
Shareholding: 2,500 shares
Anders Gersel Pedersen has over 33 years of
experience in the international pharmaceutical
industry. Served in various roles at H. Lundbeck A/S
in Denmark (CSE: LUN), including most recently as
Executive Vice President of Research &
Development, as responsible for the discovery and
development of the product pipeline from preclinical
activities to post-launch marketing studies. Prior to
that, served in various roles at Eli Lilly and Company
(NYSE: LLY), including most recently as a director
overseeing worldwide clinical research in oncology.
Member of the European Society of Medical
Oncology, the International Association for the Study
of Lung Cancer and the American Society of Clinical
Oncology. Serves on the supervisory boards of
Avillion LLP, Bavarian Nordic A/S (CSE: BAVA), AELIS
Farma SA, and Genmab A/S (CSE: GMAB). He
received his medical degree and a doctoral degree in
neuro-oncology from the University of Copenhagen
and a B.Sc. in Business Administration from
Copenhagen Business School.
Independent of Hansa and its executive
management.
Independent of major shareholders of Hansa.
Hilary Malone
Born 1965
Member of the Board since 2021, chair of the
US Committee, and member of the
Scientific Committee.
Shareholding: –
Hilary Malone has over 25 years of experience in
global drug development, regulatory and government
affairs, manufacturing and commercialization within
the pharmaceutical industry. She has served as Chief
Executive Officer of a private life sciences company
in start-up phase since November 2021. She
previously served as Chief Operating Officer and
Executive Vice President at Valo Health Inc., and as
the Chief Regulatory Officer and Senior Vice
President & Head of Global Regulatory Affairs at
Sanofi Inc. (subsidiary of Sanofi SA (Euronext: SAN)).
Previous experience also includes senior regulatory
and drug development roles at Reata
Pharmaceuticals, Inc. (NASDAQ: RETA), Pfizer Inc.
(NYSE:PFE), Wyeth, LLC (acquired by Pfizer Inc.),
AstraZeneca plc (LSE:AZN) and GlaxoSmithKline plc
(LSE: GSK). Hilary has also served on the board of
Inhibikase Therapeutics (NASDAQ: IKT). She holds a
Ph.D. in Molecular Neuropharmacology and a B.Sc.
in Physiology from the University of Dundee,
Scotland.
Independent of Hansa and its executive
management.
Independent of major shareholders of Hansa.
The Board
continued
4
5
6
3
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Remuneration
Governance
The Board
continued
The Board of Directors’ work in 2022
During 2022, the Board has held 18 meetings, of which one was the inauguration meeting, and
seven was held via Teams. The Board has also made resolutions per capsulam at six occasions.
At the Board meetings held during the 2022 financial year, the directors were present as set forth
below. The number of meetings and the maximum number of meetings each director could have
been present at during the financial year are stated in parentheses.
Evaluation of the Board of Directors’ work
Pursuant to the Code, the Board is to evaluate its work annually, using a systematic and
structured process, with the aim of developing the Board’s working methods and efficiency.
The evaluation has been carried out by the chair of the Board and an independent evaluation
company, in the beginning of 2022, interviewing the directors with questions about the work
of the Board. The result of the responses has been verbally declared to the directors and the
members of the Nomination Committee.
Board members and meeting presence for the reporting period,
1 January – 31 December 2022
Board member
Elected
Present at meetings
of the Board
Present at meetings
of the Remuneration
Committee
Present at meetings
of the Audit Committee
Present at meetings
of the Scientific
Committee
Present at meetings
of the US Committee
Independent in relation
to the Company and
Executive management
Independent in relation
to the Company’s
largest shareholders
Ulf Wiinberg
2
2016
10(10)
5(5)
Yes
Yes
Peter Nicklin
1,3
2022
8(8)
1(1)
1(1)
1(1)
Yes
Yes
Hilary Malone
2021
18(18)
1(1)
1(1)
Yes
Yes
Anders Gersel Pedersen
2018
18(18)
5(6)
1(1)
Yes
Yes
Andreas Eggert
2018
18(18)
6(6)
7(7)
1(1)
Yes
Yes
Eva Nilsagård
2019
17(18)
7(7)
Yes
Yes
Mats Blom
2019
18(18)
7(7)
Yes
Yes
1
Board member since 2022 AGM.
2
Board member until 2022 AGM.
3
Member of Remuneration Committee, Scientific Committee and U.S. Committee since 2022 AGM.
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Governance
The Board
continued
Board committees
Audit Committee
After the 2022 AGM, the Audit Committee consisted of Eva Nilsagård, chair, Mats Blom and
Andreas Eggert. The Audit Committee is obligated to keep the minutes of its meetings and
make the minutes available to the Board. The Audit Committee shall perform the duties
incumbent upon audit committees as required by law and the Code.
The Audit Committee assists the Board in overseeing the Company’s accounting and
financial reporting processes. The Audit Committee consists exclusively of members of the
Board who are financially literate and are each considered an “audit committee financial
expert” as defined by applicable SEC rules and has the requisite financial sophistication as
defined under the applicable Nasdaq rules and regulations. The Board has determined that
all of the members of the Audit Committee satisfy the “independence” requirements set forth
in Rule 10A-3 under the Exchange Act. The Audit Committee is governed by a charter that
complies with Nasdaq rules.
The primary duties of the Audit Committee are to:
>
Assist the Board in overseeing the Company’s financial position, performance, and
reporting;
>
With respect to the financial reporting, monitor the effectiveness of the Company’s internal
control system, internal audit and risk management;
>
Keep itself informed of the audit of the annual accounts and consolidated accounts;
>
Review and monitor the auditor’s impartiality and independence, and, in this context,
particularly monitor whether the auditor is providing the Company with services other than
auditing services; and
>
Take decisions regarding guidelines for services other than the auditing services which the
external auditor can provide.
Remuneration Committee
After the 2022 AGM, the Remuneration Committee has consisted of Andreas Eggert, chair, Anders
Gersel Pedersen and Peter Nicklin. The Remuneration Committee is charged with performing the
duties set forth in the Swedish Corporate Governance Code. The Remuneration Committee is
obligated to keep minutes of its meetings and make the minutes available to the Board.
The primary duties of the Remuneration Committee are to:
>
Propose guidelines and principles for remuneration and other terms of employment of the
Chief Executive Officer and senior executives;
>
Monitor and evaluate any programs pending or adopted during the year for variable
remuneration for senior executives;
>
Monitor and evaluate the implementation of the guidelines for remuneration of senior
executives adopted by the AGM, as well as applicable remuneration structures and levels
for the Company; and
>
Oversee and administer the Company’s employee share option scheme or equity incentive
plans in operation from time to time.
Scientific Committee
After the 2022 AGM, the Scientific Committee consists of Anders Gersel Pedersen, chair,
Andreas Eggert, Peter Nicklin and Hilary Malone. The committee is obligated to keep minutes
of its meetings and make the minutes available to the Board.
The primary duties of the Scientific Committee are to:
>
Assist the Board with recommendations regarding the Company’s research and
development strategies and possibilities; and
>
Perform such other duties as are considered necessary and appropriate in conjunction with
the work set forth above and perform such other duties as instructed by the Board from
time to time.
U.S. Committee
After the 2022 AGM, the U.S. Committee consists of Hilary Malone, chair, and Peter Nicklin.
The U.S. Committee is obligated to keep minutes of its meetings and make the minutes
available to the Board.
The primary duties of the U.S. Committee are to:
>
Discuss and provide input to significant issues and aspects related to the Company’s U.S.
operations and environment, including R&D, regulatory and commercial aspects; and
>
Provide advice and proposals for resolutions, subject to final approval by the Board or the
CEO, as the case may be, regarding matters related to the Company’s and the group’s U.S.
operations and development.
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Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Remuneration
Governance
Executive management
The Board appoints a CEO to manage the Company. In addition to the CEO, there are five
individuals who together make up Company executive management:
>
Senior Vice President, Chief Financial Officer
>
Senior Vice President, Chief Commercial Officer
>
Senior Vice President, Chief Scientific Officer and Chief Operating Officer
>
Senior Vice President, Chief Human Resources Officer
>
Senior Vice President, Chief Medical Officer
The executive management holds meetings every month to discuss the Group’s earnings and
financial position, the status of research and development projects, operational and strategic
issues, and follow-up on budgets and forecasts.
The CEO’s responsibility
The CEO is responsible for managing the Company’s day-to-day operations pursuant to the
Board’s guidelines and instructions. The CEO is also responsible, in accordance with the
Board’s written instructions, for preparing and presenting to the Board issues which fall
beyond the scope of day-to-day management, and he must act in accordance with the
instructions to the CEO adopted by the Board, the decisions of the Board and the general
meeting, and in the best interests of all shareholders.
He must also respect the fiduciary duty and duty of confidentiality which apply to affairs and
circumstances which might cause damage to the Company if disclosed, as well as the duty to
report matters and circumstances which are material to the Company.
In accordance with the Board’s instructions, the CEO must take all measures which are
necessary to ensure that the Company’s bookkeeping is legally compliant and to ensure that
funds are managed in a satisfactory manner. Accordingly, it is the CEO’s responsibility to
ensure that the Company has good internal management and routines to ensure application
of the adopted principles for financial reporting and internal control.
Further, the CEO shall each month (except for January and July) compile a report regarding
the Company’s financial situation. He is responsible for ensuring that the Company complies
with applicable laws and guidelines, including Swedish law, the Nordic Main Market Rulebook
for Issuers of Shares and the Code. The CEO must ensure, at a minimum, that the six-month
report or the nine-month report is reviewed by an auditor. The CEO also has specific
responsibility to ensure the competitive supply of all purchases of goods or services
exceeding SEK 1 m. The CEO must provide the Board with all necessary background
information and documentation, both before and between Board meetings. The CEO must
attend Board meetings unless the chair informs him that he need not to attend. The CEO must
also attend all general meetings of the Company.
The CEO may not have any engagements outside of the Company without the
Board’s approval.
The CEO is responsible for implementing the strategy approved by the Board and to propose
such other strategies and operational measures to the Board which he deems appropriate.
The CEO is responsible for the Company’s internal organization but must obtain the Board’s
approval prior to major organizational changes. The CEO is responsible for issuing and
maintaining instructions for delegation to senior executives of the Company. He is also
responsible for entering into or terminating employment agreements and for other
employment terms and conditions; however, the chair of the Board’s approval is necessary for
such issues in respect of senior executives.
In a crisis situation, it is the CEO’s responsibility to inform the Board immediately and, if
necessary, to form and instruct a crisis committee and to prepare a contingency plan for the
business. The CEO must immediately report any event or procedure which he suspects may
be significantly adverse to the business or the Company’s financial position, e.g., a liquidity
crisis, to the chair of the Board.
Information regarding the CEO’s age, primary education, work experience, significant
engagements outside of Hansa Biopharma, and his holdings of shares in the Company and
those of closely related persons are set forth below.
Senior executives
Hansa Biopharma’s senior executives comprise six individuals per 31 December 2022:
President and CEO Søren Tulstrup; Senior Vice President, Chief Scientific Officer and Chief
Operating Officer Christian Kjellman; Senior Vice President, Chief Financial Officer Donato
Spota; Senior Vice President, Chief Commercial Officer Henk Doude van Troostwijk; Senior
Vice President, Chief Medical Officer Achim Kaufhold and Senior Vice President, Chief Human
Resources Officer Anne Säfström Lanner.
Hansa Biopharma’s current senior executives, the years when they assumed their positions,
their years of birth, education, work experience, significant engagements outside the Company
and holdings in Hansa Biopharma as of 31 December 2022 are listed further below in this
Corporate Governance report.
Holdings in the Company include both one’s own holdings and/or those of closely
related persons.
The number of share rights refers to the maximum number of ordinary shares which the
executive may obtain as a result of the implementation of the incentive programs LTIP2020,
LTIP2021 and LTIP2022. Following the maturity of the incentive programs and provided that
certain performance conditions have been fulfilled, the share rights will entitle the holder to
receive a certain number of ordinary shares free of charge. The allocation of shares could be
lower or zero depending on the share price development and whether the performance
conditions are met.
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Directors’ report
Financials
Remuneration
Governance
Søren Tulstrup
Born 1965
President and CEO
Shareholding: 26,541
Share rights: 217,278
ESOs: 435,107
Søren Tulstrup has served as President and Chief
Executive Officer since March 2018. He has extensive
experience as a senior executive in the global
biopharma industry. Prior to joining Hansa, Søren
served as Chief Executive Officer of Vifor Pharma AG
(SIX: VIFN), (now part of CSL Behring), and he has
also served as President & Chief Executive Officer of
Santaris Pharma A/S (now part of F. Hoffmann-La
Roche AG (SIX: ROG)). Furthermore, Søren has
served in several senior general management and
commercial roles within Shire Pharmaceuticals (now
The Takeda Pharmaceutical Company Limited (TSE:
4502)), Merck & Co., Inc. (NYSE: MRK) and Sandoz
Pharma AG (now Novartis AG, or Novartis (NYSE:
NVS)) in both Europe and the United States. He holds
a Master of Science, Economics and Business
Administration from Copenhagen Business School.
Christian Kjellman*
Born 1967
Senior Vice President, Chief Scientific Officer and
Chief Operating Officer
Shareholding: 6,213
Share rights: 123,639
ESOs: 197,296
Christian Kjellman has served as Chief Scientific
Officer since 2008 and Chief Operating Officer since
2020. Prior to joining Hansa, he served as Principal
Scientist at BioInvent AB (STO: BINV), where he
focused on novel target evaluation and antibody
technology. Prior to that, Christian served as Head of
Research at the biopharmaceutical development
company Cartela AB. He has extensive research
experience in cell and molecular biology and as an
Assistant Professor in Molecular Genetics at Lund
University. Christian holds a M.Sc. in Chemical
Biology and a Ph.D. in Tumour Immunology from
Lund University.
* On 30 January 2023 Hansa announced the planned
departure of Christian Kjellman by 2024. As of
1 February 2023 Christian Kjellman no longer serves
as Chief Scientific Officer nor Chief Operating Officer.
Donato Spota
Born 1971
Senior Vice President, Chief Financial Officer
Shareholding: 5,673
Share rights: 123,639
ESOs: 236,842
Donato Spota has served as Chief Financial Officer
since May 2019. He has more than 25 years of
pharmaceutical industry experience in international
environments, including strategic finance, business
development, investor relations and international
capital markets transactions. Prior to joining Hansa,
he served in various roles at Basilea Pharmaceutica
AG (SIX: BSLN), including as Chief Financial Officer.
Prior to that, he held different finance roles at F.
Hoffmann-La Roche AG (SIX: ROG). He holds a B.A.
in Information Technology from the Swiss BBT
(Bundesamt für Berufsbildung und Technologie) and
an M.B.A. from the Hochschule für Wirtschaft und
Umwelt Nürtingen-Geislingen.
1
2
3
Executive management
continued
The number of ESOs refers to the number of
employee stock options which the executive
holds following the implementation of the
incentive programs LTIP2019, LTIP2020,
LTIP2021 and LTIP2022. In LTIP2019, each
employee stock option entitles the holder to
subscribe for one new ordinary share at a
subscription price corresponding to 110
percent of the volume weighted average
share price during the ten (10) trading days
immediately prior to the offer to subscribe
for the employee stock options. In
LTIP2020, LTIP2021 and LTIP2022, each
employee stock option entitles the holder to
subscribe for one new ordinary share at an
exercise price corresponding to 125 percent
of the volume weighted average share price
during the 10 and 30 trading days,
respectively, immediately preceding the
respective allotment of the employee stock
options. The employee stock options were
allotted free of charge and have a vesting
period of three years and an exercise period
of three years.
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Directors’ report
Financials
Remuneration
Governance
Henk Doude van Troostwijk*
Born 1965
Senior Vice President, Chief Commercial Officer
Shareholding: 2,564
Share rights: 95,000
ESOs: 131,231
Henk Doude van Troostwijk has served as Senior
Vice President and Chief Commercial Officer since
June 2019, and previously as Vice President Global
Commercial Operations for three years. Prior to
joining Hansa, Henk served as General Manager of
European Commercial Operations and Emerging
Markets at Raptor Pharmaceutical Corp. (acquired by
Horizon Pharma plc (NASDAQ: HZNP)). Prior to that,
he served as Business Unit Director Oncology and
Transplantation at Genzyme Europe B.V. (acquired by
Sanofi S.A. (Euronext: SAN)). Henk holds an M.B.A.
from Henley Management College at the University of
Reading, UK.
* As of 16 March 2023, Henk holds the role as
Vice President, Commercial Excellence.
Anne Säfström Lanner
Born 1969
Senior Vice President,
Chief Human Resources Officer
Shareholding: 3,565
Share rights: 95,000
ESOs: 110,000
Anne Säfström Lanner has served as Chief Human
Resources Officer since June 2020, and served as
Vice President Global Human Resources from 2019
to June 2020. Prior to joining Hansa, she served in
various senior roles at the European Spallation
Source, a European multi-disciplinary research
facility, including Head of Resourcing. Prior to that,
Head of Human Resources at Cellavision AB
(STO:CEVI). Anne has held positions as Head of
HR, Head of Resourcing, HR Manager & Deputy
Head of HR and has extensive experience from fast
growing start-up international companies. Holds a
Bachelor of Social Science in Human Resource
Management, focusing on strategic organizational
development & leadership, from Lund University.
Achim Kaufhold*
Born 1957
Senior Vice President, Chief Medical Officer
Shareholding: –
Share rights: 81,000
ESOs: 94,000
Achim Kaufhold has served as Chief Medical Officer
since June 2020. He is a highly experienced senior
leader in immunology, infectious diseases and
oncology. Achim has over 25 years of international
experience within the biotechnology and
pharmaceutical industry. Prior to joining Hansa,
Achim served in various senior executive positions in
general management, product and business
development. Has served as Chief Executive Officer
of Affitech AS and Pharmexa A/S (both companies
merged), Chief Medical Officer of Basilea
Pharmaceutica AG (SIX: BSLN), Pharmexa A/S,
Chiron (acquired by Novartis (NYSE: NVS)) and Berna
Biotech AG (now Johnson & Johnson (LSE: JNJ)).
Prior to that, he headed the worldwide clinical
development of the pediatric vaccine portfolio of
GlaxoSmithKline plc (LSE: GSK). Currently also
serves on the board of directors of Biosergen AB
(STO: BIOSGN). Graduated as a Doctor of Medicine
from the University of Cologne and holds a
professorship in Medical Microbiology and Infectious
Diseases at the University of Aachen, Germany.
* As of 1 February 2023, Achim also serves as ad-interim
Chief Scientific Officer.
Matthew Shaulis*
Born 1973
Chief Commercial Officer and US President,
effective 16 March 2023
Shareholding: –
Share rights: –
ESOs: –
Matthew Shaulis has served as Chief Commercial
Officer and President of the U.S. affiliate, Hansa
Biopharma Inc since March 2023. Prior to his role at
Hansa Biopharma, Matthew gained over 20 years of
US and international experience in the
pharmaceutical industry in general management,
global strategic and in-line marketing, sales
management, business development, and product
and indication launches. He held several senior
executive roles at Pfizer Inc. (NYSE: PFE), including
President of Inflammation & Immunology for
International markets in Europe and Asia, President
of Oncology for North America, and more recently as
the Senior Vice President responsible for leading the
company’s global commercial and medical
go-to-market model transformation. Prior to that,
Matthew served in various leadership roles at Teva
Pharmaceutical Industries (NYSE: TEVA), Cephalon,
Johnson & Johnson (LSE: JNJ), and Schering-Plough
(now part of Merck & Co., Inc. (NYSE: MRK)). He
holds a B.S. in Accounting from Pennsylvania State
University and an M.B.A. from The Fuqua School of
Business, Duke University, North Carolina.
* As of 16 March 2023, Matthew Shaulis joins Hansa as
Chief Commercial Officer and US President.
5
6
7
4
Executive management
continued
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Market
Technology
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New
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Directors’ report
Financials
Remuneration
Governance
Internal controls and risk management
in respect of the financial reporting
Introduction
The following description is based on guidelines issued in
2008 by the Confederation of Swedish Enterprise and FAR.
The Company’s internal control procedures in respect of
financial reporting have been formulated to ensure, with
reasonable certainty, quality, and accuracy in the reporting.
The procedures are designed to ensure that the reporting is
prepared in accordance with applicable laws and regulations
as well as the requirements which are imposed on companies
with shares admitted for trading on a regulated market in
Sweden. The important prerequisites for achieving this are:
(i) the existence of a satisfactory control environment; (ii) the
execution of reliable risk assessments; (iii) the existence of
established control structures and control activities; and
(iv) satisfactory information, communications, and follow-up.
Internal audit
The Board has evaluated the need for an internal audit
function and has concluded that it is not warranted for Hansa
due to the scope and size of the operations and because the
Board’s follow-up of the internal control is deemed sufficient
to ensure that the internal control is effective. The Board will
review the need in the event of changes which may give rise to
re-evaluation and at least once annually.
Control environment
Internal control is based on Hansa’s control environment,
which comprises the values and ethics from which the Board,
the Audit Committee, the CEO, the Executive Committee, and
other employees communicate and operate. The control
environment also includes the Company’s organizational
structure, leadership, decisional structure, decision-making
authority, responsibility, and employee proficiency.
Risk assessment
Risk identification and evaluation are carried out in a manner
to also include risks regarding financial reporting. As part of
this procedure, items in the income statement and statement
of financial position entailing a great risk of significant error
are identified. For Hansa, accrued project costs in the
Company’s clinical projects have, at various times, involved
significant amounts. The size of these is based, to a great
extent, on management’s assessment of the degree of
completion. More recently, product sales, contract revenue
and inventory valuation became items which could include an
elevated risk of significant error as they may involve a
significant amount of judgement and estimates. Further, cash
and equivalents, as well as current investments, comprise a
significant percentage of the Company’s total assets and are
therefore deemed to give rise to a risk in the financial
reporting. Moreover, the fact that Hansa’s administration is
handled by a relatively small number of individuals is listed as
a risk since the dependency on a small number of key
individuals becomes great and the possibility to allocate tasks
and responsibility becomes limited. The Company’s risk
management policy and further policies include controls to
prevent and detect shortcomings in these and other areas.
Control structure and control activities
The Board’s rules of procedure and the instructions for the
CEO and Board committees ensure a clear allocation of roles
and responsibility. The Board has overall responsibility for
internal controls. The CEO is responsible for the development
of the system of routines, procedures, and controls for the
day-to-day operations. This includes, among other things,
guidelines, and role descriptions for the various decision-
makers as well as regular reporting to the Board based on
established routines. Procedures, routines, instructions and
templates for the financial reporting and the day-to-day
administrative financial operations and financial issues are
documented in Hansa’s policies. Routines and activities have
been designed to manage and rectify significant risks which
are related to financial reporting, and which are identified in
the risk analysis. The most significant, overall, group-wide
corporate governance documents are the work procedures
for the Board, instructions for the CEO, disclosure policy,
insider policy, risk management policy, and Code of Conduct.
The primary purpose of control activities is the prevention
and early-stage detection of errors in the financial reporting
so that they can be addressed and corrected. The Group has
implemented entity level controls as well as process controls.
Access to IT systems is limited and controlled in accordance
with powers and authorization. Manual and automated
control steps are incorporated throughout the accounting,
financial closing and financial reporting process. The CFO
compiles monthly financial reports which, among other
things, are to report earnings and cash flow for the preceding
period and state budget deviations. These reports, and
above all the budget deviations, are analysed and
commented upon by Company management. Follow-up
takes place through regular meetings for review of these
reports and analyses with the various managers and project
managers. The work involved with annual accounts and
annual reports are processes which pose additional risks for
errors in the financial reports. This work is of a less repetitive
nature and contains more evaluative elements. Important
control activities include, among other things, external
confirmations (e.g. bank statements or third party vendor
confirmations) as well as ensuring that there is a properly
functioning reporting structure in which the various managers
and project managers report pursuant to standardized
templates, and that important income statement and
statement of financial position items are analyzed and
commented upon.
Information and communication
The informational activities are governed by a disclosure
policy. There are guidelines for external communications
which ensure that the Company meets high standards for
providing correct information to the shareholders and the
financial market. Hansa’s communications must be
characterized by transparency and must be correct, relevant,
reliable and clear; they may not be misleading. All
communications must take place in accordance with Nordic
Main Market Rulebook for Issuers of Shares, the Swedish
Corporate Governance Code, and the laws and requirements
imposed on Swedish companies whose shares are admitted
for trading on a regulated market. The policy applies to all
employees and directors of Hansa Biopharma and applies to
both oral and written information.
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Directors’ report
Financials
Remuneration
Governance
The Board releases annual reports, financial statements and
interim reports. All financial reports are published on the
website (www.hansabiopharma.com) simultaneously as being
published pursuant to Nasdaq Stockholm’s rules and
regulations. The annual report is made available on the
website and is provided as a hard copy to those shareholders
who so wish.
Follow-up
The Board’s follow-up on internal controls in respect of the
financial reporting takes place, among other things, through
follow-up by and through the Audit Committee, on the work
and reports of the CFO and the external auditors. The work
includes ensuring that measures are taken in respect of the
shortcomings and proposed measures generated in
conjunction with the external audit. The focus of the
follow-up is Hansa compliance with policies, rules and
guidelines; and the existence of efficient and suitable
processes for risk management, operational management,
and internal control. Each year, the external auditor follows
up on the selected elements of the internal control within the
scope of the statutory audit.
The auditor reports the results of the examination to the
Audit Committee and Company management. Significant
observations are reported, where applicable, directly to
the Board.
The CEO is responsible for compiling all experience from the
Company’s risk management work and, following
discussions with Company management, proposing any
changes which the CEO deems necessary or applicable.
The Board will decide on any changes.
Internal controls and risk management
continued
Compliance
Hansa has adopted a Code of Conduct for all of its directors,
officers, and associates which sets forth the standards for
business behaviours that apply throughout the Company
and describes the expectations Hansa has for its business
partners, and those acting on behalf of the Company.
The Code of Conduct contains guidance in the areas of
personal and corporate integrity, responsibility toward the
Company, its associates and the community as well as
responsible and comprehensive compliance management.
Aligned with the Code of Conduct, Hansa has established
a global compliance framework. This compliance
framework includes, but is not limited to, compliance and
business unit policies and procedure documents,
compliance risk mitigation and violation reporting
processes, data privacy precautions as well as internal
auditing and monitoring activities.
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Market
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Directors’ report
Financials
Remuneration
Governance
Executive Remuneration – to be approved
by the 2023 AGM
The following remuneration guidelines were approved at the 2022 AGM
and are proposed for re-approval at the 2023 AGM without changes.
The senior executives, the CEO and members of the executive committee, fall within the
provisions of these guidelines. To the extent a board member conducts work for the Company, in
addition to the board work, consulting fees and other compensation for such work may be paid.
The policy is forward looking, i.e. applicable to remuneration agreed, and amendments to
remuneration already agreed, after adoption of the guidelines by the 2023 AGM.
A prerequisite for the successful implementation of the Company’s business strategy and
safeguarding of its long-term interests, including its sustainability, is that the Company can recruit
and retain qualified personnel, consequently, it is necessary that the Company offers market
competitive remuneration.
Long-term (share-based) incentive programs have been implemented in the Company. Such
programs have been resolved by the AGM and are therefore excluded from these guidelines. The
program includes, among others, the CEO and other senior executives in the Company. The
performance criteria used to assess the outcome of the plans are distinctly linked to the business
strategy and thereby to the Company’s long-term value creation, including its sustainability.
For more information regarding these incentive programs, including the criteria which the
outcome depends on, please see https://hansabiopharma.com/this-is-hansa/corporate-
governance.
The guidelines enable the Company to offer senior executives a competitive remuneration. The
remuneration shall be on market terms and may consist of the following components: fixed base
salary, variable cash remuneration (including STI), pension benefits and other benefits. The
components, their purpose and link to the Company’s business strategy are described below.
For information regarding Hansa Biopharma’s strategic priorities, please visit https://
hansabiopharma.com/this-is-hansa/our-commitment/.
For information regarding Hansa Biopharma’s equity story, please visit https://investors.
hansabiopharma.com/English/our-equity-story/default.aspx.
The decision-making process to determine, review and implement the guidelines
The Board of Directors has established a committee (the Remuneration Committee), with the task
of preparing, within the Board of Directors, the guidelines for remuneration for senior executives.
The Board of Directors shall propose revised guidelines at least every fourth year and submit it to
the AGM. The guidelines shall be in force until new guidelines are adopted by the general meeting.
The Remuneration Committee shall also monitor and evaluate programs for variable remuneration
for senior executives, the application of the guidelines for executive remuneration as well as the
current remuneration structures and compensation levels in the Company. The members of the
Remuneration Committee are independent of the Company and its executive management.
Unless otherwise stated herein, the Board of Directors shall resolve matters regarding
remuneration and employment provisions for all other senior executives. The CEO may decide
upon Variable Cash Remuneration, including STI, for the other senior executives. The
Remuneration Committee and the CEO, as applicable, shall continuously report to the Board of
Directors. The CEO and the other senior executives shall not be present when their respective
remuneration terms are decided.
Additionally, the general meeting may – irrespective of these guidelines – resolve on, among other
things, share-related or share price-related remuneration.
Fixed Base Salary
Purpose and link
to strategy
Supports the attraction and retention of the best talent.
Ensures competitiveness while controlling fixed costs to maximise efficiency.
Operational Details
>
Normally reviewed annually and increases will usually be effective from
1 April or foll
owing a change in responsibilities.
>
The Remuneration Committee will consider, among other things, the
following par
ameters when reviewing fixed base salary:
Economic
and salary conditions and trends.
The individual’s performance and responsibilities.
Base salaries and total remuneration at other companies that operate in the
same markets, typically benchmarked against similar roles.
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Directors’ report
Financials
Remuneration
Governance
Variable Cash Remuneration
A portion of the total remuneration for the senior executives are linked to business
performance so that total remuneration will increase or decrease in line with performance,
thus promoting the Company’s business strategy and long-term interests (see “Annual
Short-Term Incentive (STI)” below).
For retention or recruitment purposes or extraordinary performance beyond the individual’s
ordinary tasks the Remuneration Committee, based on proposal of CEO, may, on an
individual basis, decide on an additional variable cash remuneration. Such remuneration may
not exceed an annual amount corresponding to 30 percent of the total fixed annual cash
salary and may not be paid more than once each year per individual.
Annual Short-Term Incentive (STI)
Purpose and link
to strategy
To incentivise and create focus on the delivery of corporate objectives and
strategic criteria.
Operational Details
>
The performance criteria, weighting and targets for the corporate objectives
are to be proposed by the Remuneration Committee annually, evaluated and
approved by the Board of Directors. Stretched targets shall be set by
reference to the Company’s operating plan and historical and projected
performance.
>
The performance criteria, weighting and targets for the individual objectives
are to be proposed, evaluated and approved annually by the CEO as manager
for members of the executive committee or, if it is not the CEO, then the
respective manager for such members of the executive committee, and for the
CEO the Remuneration Committee.
>
The outcome of criteria for awarding STI is to be measured over a period of
one year and depend on the degree of fulfilment of predetermined targets.
>
The Board of Directors shall have the possibility, under applicable law or
contractual provisions, subject to the restrictions that may apply under law or
contract, to reclaim in whole or in part STI paid on incorrect grounds
(claw-back).
Opportunity Levels
The maximum opportunity for STI can amount up to max 75 percent of fixed
base salary.
The Remuneration Committee shall have the possibility to review the opportunity
levels in order to ensure market competitiveness.
Performance criteria
The STI plan awards shall be based on corporate objectives and individual
objectives and be linked to predetermined and measurable criteria.
The criteria shall be designed so as to contribute to the Company’s business
strategy and long-term interests.
For financial objectives, the evaluation shall be based on the latest financial
information made public by the Company.
Executive Remuneration – to be approved by the AGM 2023
continued
Pension Benefits
Purpose and link
to strategy
Provide competitive and cost-effective pension benefits.
Operational Details
Pension benefits shall be defined contribution (premium defined) unless the
individual concerned is subject to defined benefit pension under mandatory
collective agreement provisions.
>
Variable cash remuneration shall not qualify for pension benefits unless the
executive officer is part of mandatory collective agreed provisions where this
is stipulated.
>
Early retirement may be offered selectively and only after a special decision by
the Remuneration Committee, with a defined contribution early
retirement scheme.
>
For executive officers governed by rules other than Swedish, pension benefits
may be duly adjusted for compliance with mandatory rules or established local
practice, taking into account, to the extent possible, the overall purpose of
this policy.
Opportunity Levels
The pension premiums for defined contribution pension shall amount to not more
than 30 percent of the fixed base salary.
Other Benefits
Purpose and link
to strategy
Provide competitive and cost-effective benefits.
Operational Details
>
Other benefits may include but is not limited to life insurance, survivor benefit,
accidental death and disability insurance, medical insurance/cover
(Sw.: sjukvårdsförsäkring), and a company car or car allowance.
>
For executive officers governed by rules other than Swedish, benefits may be
duly adjusted for compliance with mandatory rules or established local
practice, taking into account, to the extent possible, the overall purpose of this
policy.
>
Executive officers who are international assignees (for example expatriates) to
or from Sweden may receive additional remuneration and other benefits to the
extent reasonable in light of the special circumstances associated with the
international assignment arrangement, taking into account, to the extent
possible, the overall purpose of this policy.
Opportunity Levels
Other benefits may amount to not more than 10 percent of the fixed annual cash
salary and shall be set at a level which the Remuneration Committee considers to:
>
Provide the relevant level of benefit depending on role and the individual
circumstances.
>
Be in line with comparable roles in companies with similar size and complexity
in the relevant market.
>
Be appropriate compared to the benefits offered to the wider workforce in the
relevant market.
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Overview
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Remuneration
Governance
Termination of employment
Details
>
If notice of termination of employment is made by the Company:
The notice period may not exceed six months.
Fixed cash salary during the period of notice and severance pay may
together not exceed an amount equivalent to the fixed cash salary for 18
months for the CEO, i.e. 6 + 12 months.
Fixed cash salary during the period of notice and severance pay may together
not exceed an amount equivalent to the fixed cash salary for 6 months, and in
exceptional cases, 12 months for the other senior executives.
>
W
hen termination is made by the senior executive the period of notice may not
exceed six months. No severance pay will be paid.
>
R
epatriation – If the senior executive is an international assignee the Company
may reimburse reasonable cost for the repatriation of good leavers, taking into
account, to the extent possible, the overall purpose of this policy.
For senior executives governed by rules other than Swedish, payments in
connection with termination may be duly adjusted for compliance with mandatory
rules or established local practice, taking into account, to the extent possible, the
overall purpose of this policy.
Salary and employment conditions for employees
In the preparation of the Board of Directors’ proposal for this remuneration policy, salary and
employment conditions for employees of the Company have been taken into account by including
information on the employees’ total income, the components of the remuneration and increase
and growth rate over time.
Derogation from the policy
The Board of Directors may temporarily resolve to derogate from the policy, in whole or in
part, if in a specific case there is special cause for the derogation and a derogation is
necessary to serve the Company’s long-term interests, including its sustainability, or to
ensure the Company’s financial viability. As set out above, the Remuneration Committee’s
tasks include preparing the Board of Directors’ resolutions in remuneration-related matters.
This includes any resolutions to derogate from the policy.
Additional information regarding executive remuneration is available in Hansa’s 2022
Annual Report.
Executive Remuneration – to be approved by the AGM 2023
continued
Hansa Biopharma Annual Report 2022
133
Overview
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Remuneration
Governance
Hansa Biopharma Annual Report 2022
134
Overview
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
135
Remuneration Report
Remuneration
11
135
Remuneration report 2022
Introduction
This remuneration report provides an outline of how Hansa’s guidelines for remuneration (the
“Remuneration guidelines”), adopted by the annual general meeting 2022, were implemented in
2022. The report also provides information on remuneration to the CEO and a summary of
Hansa’s outstanding share-based long-term incentive programs. The report has been prepared
in accordance with the Swedish Companies Act and the Remuneration Rules issued by the
Swedish Corporate Governance Board.
Further information on senior executive remuneration is available in Note 14 to the Consolidated
Financial Statements in the Annual Report 2022. Information on the work of the remuneration
committee in 2022 is set out in the corporate governance report included in the Annual Report
2022.
Remuneration of the Board of Directors is not covered by this report. Such remuneration is
resolved annually by the annual general meeting and disclosed in Note 14 to the Financial
Statements of the Parent Company in the Annual Report 2022.
Key Developments 2022
Company performance in 2022
The CEO summarizes the Company’s overall performance in his statement in the Annual
Report 2022. In addition, the directors report included in the Annual Report 2022 summarizes
the Company’s 2022 business and operations.
The Company’s remuneration guidelines: scope, purpose and deviations
A prerequisite for the successful implementation of the Company’s business strategy and
safeguarding of its long-term interests, including its sustainability, is that the Company is able to
recruit and retain highly qualified personnel, consequently, it is necessary that the Company
offers market competitive remuneration. This has been becoming of paramount importance as
the Company is required to attract talent from and in Sweden, other European countries and the
US. Under Hansa’s remuneration guidelines, remuneration of senior executives shall be on
market terms and may consist of the following components: fixed base salary, variable cash
remuneration (including STI), pension benefits and other benefits.
The Remuneration guidelines, adopted by the annual general meeting 2022, can be found in
the Governance section in the Annual Report 2022. During 2022, the Company has complied
with the applicable Remuneration guidelines adopted by the general meeting. No deviations
from the guidelines have been decided and no derogations from the procedure for
implementation of the guidelines have been made. The auditor’s report regarding the
Company’s compliance with the guidelines is available on the Company’s website,
www.hansabiopharma.com. No remuneration has been reclaimed.
In addition to remuneration covered by the Remuneration guidelines, the annual general
meetings of Hansa have also resolved to implement long-term share-based incentive plans for
certain groups of Hansa employees and on remuneration guidelines for the Board of Directors.
Table 1 – Total remuneration of the CEO (kSEK)
1
Table 1 below sets out the total remuneration related to Hansa’s CEO for 2022.
1
Fixed remuneration
2
Variable remuneration
Name of Director, position
Financial year
Base salary
Other benefits
One-year
variable
Multi-year
variable
3
Extraordinary
items
4
Pension
expense
5
Total
remuneration
6
Proportion of
fixed and variable
remuneration in
%
Søren Tulstrup (CEO)
2022
7,586
2
-
4,024
779
3
0
0
12,389
61% / 39%
1
Except for Multi-year variable remuneration, the table reports remuneration earned in 2022. Multi-year variable remuneration is reported if vested in 2022, as set out in column 8 of Table 2 and column 10 of Table 3 below (as applicable). Disbursement of any payments may or may
not have been made the same year
2
Includes KSEK 1,694, representing 30% of base salary, intended for own pension contribution
3
Corresponds to 15,466 ordinary Hansa shares at a value of SEK [open] each received under the LTIP 2019 and 66,347 stock options at no value vested and earned under the LTIP 2019. The stock options do not carry value as of the date of vesting since share price was below the
exercise price.
136
Remuneration report 2022
continued
Share based remuneration
Outstanding share-based long-term incentive programs
As of December 31, 2022, the Company has four long-term incentive programs outstanding in
which amongst others also the CEO participates; long-term incentive program (“LTIP”) 2019,
2020, 2021 and 2022.. LTIP 2019 partly vested and partly lapsed during 2022.
As a general condition to all programs, any rights may only vest provided that the participant,
with certain exceptions, from the start of the incentive program and during the three (3) years
vesting period thereafter maintains his or her employment within the Group.
Long-term incentive program 2019
On May 22, 2019, the annual general meeting in Hansa Biopharma resolved to adopt a long-
term incentive program for certain employees of the Group. The long-term incentive program
2019 includes two elements; one performance-based share rights program, and one option
program comprising two series, a warrant and a employee stock option (“ESO”) series. The
CEO was granted 35,151 share rights and 66,347 employee stock options but chose not to
acquire any warrants under incentive program 2019.
Under the performance-based share rights program, each share right entitled the holder to
receive one ordinary share in Hansa Biopharma AB free-of-charge provided that the below
performance conditions were met during the vesting period. In addition to the requirement for
the participant’s continued employment, the final number of ordinary shares that each
participant was entitled to receive was conditional upon the following performance conditions
being met during the vesting period: (a) 22 percent of the shares in the event that market
approval is obtained by EMEA within the EU, (b) 22 percent of the shares in the event that at
least 10 patients enrolled in US RCT (ConfIdeS), and (c) up to 56 percent of the shares related
to the total shareholder return on the Company’s ordinary shares (if the total shareholder return
for the Company’s ordinary share during the vesting period reaches or exceeds 75 percent, the
participant will be awarded 56 percent of the performance shares and if the total shareholder
return for the Company’s ordinary share falls below 25 percent, no allotment of performance
shares will be made under this performance condition. In between the percentages, allotment
will be made linearly.
The option program comprises two series; Series 1 – Warrants, and Series 2 – Employee stock
options. Series 1 consists of warrants which can be exercised for subscription of ordinary
shares during the period from 15 June 2022 up to and including 15 July 2022. The transfer of
the warrants to participants was made at a price corresponding to the market value of the
warrants at the time of transfer.
The Company subsidized up to 100 percent of the price for the transfer of the warrants. Series 2
consists of ESOs allotted free-of-charge. The ESOs have a vesting period of three years and an
exercise period of three years. Each warrant or ESO entitles the holder to acquire one new
ordinary share in Hansa Biopharma AB at a strike price of SEK 196.20, which corresponds to
110 percent of the volume weighted average share price during the ten (10) trading days
immediately prior to the offer to subscribe for the options and/or warrants.
In total, 278,181 share rights, 149,148 ESOs and 11,000 warrants were outstanding under the
LTIP 2019 as of 1 January 2022. During 2022, 122,400 share rights and 149,148 ESOs vested,
while 155,781 share rights and 11,000 warrants lapsed.
Long-term incentive program 2020
On June 23, 2020, the annual general meeting in Hansa Biopharma resolved to adopt a long-
term incentive program for certain employees of the Group. The long-term incentive program
2020 includes two elements; one performance-based share rights program, and one employee
stock option program. The CEO has been granted 57,278 share rights and 128,760 employee
stock options (“ESO”) under the long-term incentive program 2020.
Under the performance-based share rights program, each share right entitles the holder to
receive one ordinary share in Hansa Biopharma AB free-of-charge provided that the below
performance conditions are met during the vesting period. In addition to the requirement for the
participant’s continued employment, the final number of shares that each participant is entitled
to receive is also conditional upon the following performance conditions being met during the
vesting period: (a) 22 percent of the shares in the event the U.S. randomized controlled trial
(ConfIdeS) has enrolled 64 patients, (b) 11 percent of the shares in the event that top-line data
read out of the ongoing Phase 2 study in either AMR or GBS is completed with data providing a
solid scientific rational for a path forward, (c) 11 percent of the shares in the event that at least
70 percent of the targeted transplantation centres in Europe have been initiated, and (d) up to
56 percent of the shares related to the total shareholder return on the Company’s ordinary
shares (if the total shareholder return for the Company’s ordinary share during the vesting
period reaches or exceeds 75 percent, the participant will be awarded 56 percent of the
performance shares and if the total shareholder return for the Company’s ordinary share falls
below 25 percent, no allotment of performance shares will be made under this performance
condition. In between the percentages, allotment will be made linearly.
137
Remuneration report 2022
continued
The option program 2020 consists of ESOs allotted free-of-charge. The ESOs have a vesting
period of three years, and an exercise period of three years. Each ESO entitles the holder to
acquire one ordinary share in Hansa Biopharma AB, provided that the participant, with certain
exceptions, remains employed within the Group, at an exercise price of SEK 315.75 which
corresponds to 125 percent of the volume weighted average share price during the 10 trading
days immediately preceding the respective allotment of the ESOs.
In total, 398,311 share rights and 487,520 ESOs were outstanding under the long-term
incentive program 2020 as of 31 December 2022.
Long-term incentive program 2021
On May 12, 2021, the annual general meeting in Hansa Biopharma resolved to adopt a long-
term incentive program for certain employees of the Group. The long-term incentive program
2021 includes two elements: one performance-based share rights program, and one employee
stock option program. The CEO has been granted 80,000 share rights and 120,000 employee
stock options (“ESO”) under the long-term incentive program 2021.
Under the performance-based share rights program, each share right entitles the holder to
receive one ordinary share in Hansa Biopharma AB free-of-charge provided that the below
performance conditions are met during the vesting period. In addition to the requirement for the
participant’s continued employment, the final number of shares that each participant is entitled
to receive is also conditional upon the following performance conditions being met during the
vesting period: (a) 22 percent of the shares in the event the U.S. FDA has accepted a BLA filing
for approval of imlifidase in the U.S., (b) 11 percent of the shares in the event that a phase 3
study in either AMR or GBS is initiated or a filing for regulatory approval is accepted by either
the FDA or EMA for one of these indications or anti-GBM, (c) 11 percent of the shares in the
event that at least 80% of the targeted transplantation centers in Europe have been initiated,
and (d) up to 56 percent of the shares related to the total shareholder return on the Company’s
ordinary shares (if the total shareholder return for the Company’s ordinary share during the
vesting period reaches or exceeds 75 percent, the participant will be awarded 56 percent of the
performance shares and if the total shareholder return for the Company’s ordinary share falls
below 25 percent, no allotment of performance shares will be made under this performance
condition. In between the percentages, allotment will be made linearly.
The option program 2021 consists of ESOs allotted free-of-charge. The ESOs have a vesting
period of three years, and an exercise period of three years. Each ESO entitles the holder to
acquire one ordinary share in Hansa Biopharma AB, provided that the participant, with certain
exceptions, remains employed within the Group, at an exercise price of SEK 192.20 which
corresponds to 125 percent of the volume weighted average share price during the 30 trading
days immediately preceding the respective allotment of the ESOs.
In total, 551,263 share rights and 430,000 employee stock options were outstanding under the
long-term incentive program 2021 as of 31 December 2022.
Long-term incentive program 2022
On June 30, 2022, the annual general meeting in Hansa Biopharma resolved to adopt a long-
term incentive program for certain employees of the Group. The long-term incentive program
2022 includes two elements: one performance-based share rights program, and one employee
stock option program. The CEO has been granted 80,000 share rights and 120,000 employee
stock options (“ESO”) under the long-term incentive program 2022.
Under the performance-based share rights program, each share right entitles the holder to
receive one ordinary share in Hansa Biopharma AB free-of-charge provided that the below
performance conditions are met during the vesting period. In addition to the requirement for the
participant’s continued employment, the final number of shares that each participant is entitled
to receive is also conditional upon the following performance conditions being met during the
vesting period: (a) 22 percent of the shares in the event the U.S. FDA has approved imlifidase
in the U.S. (b) 11 percent of the shares in the event that Imlifidase has been approved, or a
Marketing Authorization Application/Biologics License Application has been submitted, in any
jurisdiction in an indication outside kidney transplant, (c) 11 percent of the shares in the event
that at least 80% of the targeted transplantation centers in Europe have had repeat business,
and (d) up to 56 percent of the shares related to the total shareholder return on the Company’s
ordinary shares (if the total shareholder return for the Company’s ordinary share during the
vesting period reaches or exceeds 75 percent, the participant will be awarded 56 percent of the
performance shares and if the total shareholder return for the Company’s ordinary share falls
below 25 percent, no allotment of performance shares will be made under this performance
condition. In between the percentages, allotment will be made linearly.
The option program 2022 consists of ESOs allotted free-of-charge. The ESOs have a vesting
period of three years, and an exercise period of three years. Each ESO entitles the holder to
acquire one ordinary share in Hansa Biopharma AB, provided that the participant, with certain
exceptions, remains employed within the Group, at an exercise price of SEK 70.00 which
corresponds to 125 percent of the volume weighted average share price during the 30 trading
days immediately preceding the respective allotment of the ESOs.
In total, 543,000 share rights and 384,000 employee stock options were outstanding under the
long-term incentive program 2022 as of 31 December 2022.
138
Remuneration report 2022
continued
Remuneration of the CEO in share rights and employee stock options
Table 2 – Remuneration of the CEO in share rights
Name,
position
The main conditions of share rights
Information regarding the reported financial year
Opening balance
During the year 2022
Closing balance 31 Dec 2022
1
Name of plan
2
Performance
period
3
Award date
4
Vesting date
5
End of retention
period
6
Share rights held
at the beginning
of the year
7
Awarded
8
Vested
9
Expired
10
Subject to a
performance
condition(s)
11
Awarded and
unvested
12
Shares subject
to a retention
period
Søren
Tulstrup
(CEO)
LTIP2019
2019-2022
2019-06-17
2022-06-17
2022-06-17
35,151
0
15,466
19,685
0
0
0
LTIP2020
2020-2023
2020-07-23
2023-07-23
2023-07-23
57,278
0
0
0
57,278
57,278
57,278
LTIP2021
2021-2024
2021-06-07
2024-06-07
2024-06-07
80,000
0
0
0
80,000
80,000
80,000
LTIP2022
2022-2025
2022-07-20
2025-07-20
2025-07-20
0
80,000
1
0
0
80,000
80,000
80,000
172,429
80,000
15,460
19,685
217,278
217,278
217,278
1 Each of the 80,000 Share rights represents a computed fair value of SEK 80.29 per share right calculated based on a Monte Carlo simulation. For further information please refer to Note14 to the Consolidated Financial Statements in Hansa Biopharma’s Annual Report 2022
Table 3 – Remuneration of the CEO in stock options
Name, position
The main conditions of stock options
Information regarding the reported financial year
Opening
balance
During the year 2022
Closing balance 31 Dec 2022
1
Name of plan
2
Performance
period
3
Award date
4
Vesting date
5
End of
retention
period
6
Exercise
Period
7
Exercise
Price (SEK)
8
Stock options
held at the
beginning
of the year
7
Awarded
8
Vested
9
Expired
10
Subject to a
performance
condition(s)
11
Awarded and
unvested
12
Shares
subject
to a retention
period
Søren Tulstrup
(CEO)
LTIP2019
2019-2022
2019-06-17
2022-06-17
2022-06-17
2022-06-17
2025-06-17
196.20
66,347
0
66,347
0
66,347
0
0
LTIP2020
2020-2023
2020-07-23
2023-07-23
2023-07-23
2023-07-23
2026-07-23
315.75
128,760
0
0
0
128,760
128,760
128,760
LTIP2021
2021-2024
2021-06-07
2024-06-07
2024-06-07
2024-06-07
2027-06-07
192.20
120,000
0
0
0
120,000
120,000
120,000
LTIP2022
2022-2025
2022-07-20
2025-07-20
2025-07-20
2025-07-20
2028-07-20
70.00
0
120,000
1
0
0
120,000
120,000
120,000
315,107
120,000
66,347
0
435,107
368,760
435,107
1 Each of the 120,000 Stock options represents a computed fair value of SEK 52.45 per stock option calculated based on a Black-Scholes valuation. For further information please refer to Note14 to the Consolidated Financial Statements in Hansa Biopharma’s Annual Report 2022
139
Remuneration report 2022
continued
Application of performance criteria related to the 202
2 CEO compensation
Both, long
-term and short-term performance measures have been selected to reflect key milestones in delivering the Company’s strategy and to encourage behaviour which is in the long-term
interest of the Company. This is reflected in the performance criteri
a related to the Company’s long-term incentive programs as well as the corporate objectives applied to performance measurement
related to the short
-term incentive program of Hansa. In selecting performance measures, the strategic objectives as well as short-term and long-term business priorities have been taken into
account.
In 202
2, the share rights program under the LTIP 2019, in which the CEO held 35,151 performance share rights, hit the vesting date. Since the pre-defined performance criteria were only partly met,
plan participants received
44% of the maximum potential share allocations. In total, 122,400 shares were allocated under the plan of which the CEO received 15,466 shares. Further, in 2022, the
employee
stock option (“ESO”) program under the LTIP 2019, in which the CEO holds 66,347 ESOs, vested. In accordance with the terms of the LTIP 2019, plan participants may exercise the
vested ESOs
over a 3-year period from vesting through 17 June 2025 at an exercise price of SEK 196.20.
Set out in Table 4 below is a description of how the criteria for payment of variable short
-term compensation have been applied for the financial year 2022. Such criteria are based on the annual
corporate objectives and form the bas
is for the short-term performance measurement of the CEO and, together with pre-defined individual objectives, accounting for up to 80% of the performance
targets
for all other members of the executive management.
Table 4
– Criteria for payment of variable short-term compensation
Name, Position
Description of the criteria related to the corporate goals
2022
corporate goals
Overall
weight
a)
Measured goal achievement
and
b)
Actual weighted outcome
Søren Tulstrup, CEO
Imlifidase commercial launch – Sales, market access, EMA post-approval commitments
3 sub-goals
19%
a)
130%
b)
24%
Progressing pipeline activities in transplantation, autoimmune indications
, gene therapy and NiceR
7 sub-goals
49%
a)
76%
b)
37%
Business
development and financial strength
2 sub-goals
27%
a)
108%
b)
30%
Corporate Social Responsibility
1 sub-goal
5%
a)
100%
b)
5%
Total: 95%
Comparative information on remuneration and Company performance
2022
2021
CEO remuneration
Søren Tulstrup, CEO
kSEK 12,451
kSEK 10,582
Company’s performance
Achievement of the annual corporate objectives
95%
85%
Operating profit /
(loss)
kSEK (611,134)
kSEK (548,282)
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Glossary
12
141
Glossary
Glossary
Adeno-associated virus (AAV)
AAV is a versatile viral vector technology that can be
engineered for very specific functionality in gene
therapy applications.
Allogeneic hematopoietic stem cell
transplantation (HSCT)
Allogeneic HSCT, also known as “bonemarrow”
transplantation, involves transferring stem cells from a
healthy person (the donor) to the patient’s body after
high-intensity chemotherapy or radiation. The donated stem
cells can come from either a related or an unrelated donor.
AMR
Antibody mediated transplant rejection.
Antibody
One type of protein produced by the body’s immune system
with the ability to recognize foreign substances, bacteria or
viruses. Antibodies are also called immunoglobulins. The
human immune system uses different classes of antibodies
so called isotypes known as IgA, IgD, IgE, IgG, and IgM.
Anti-Glomerular Basement Membrane (anti-GBM)
disease (Goodpasture syndrome)
Anti-GBM antibody disease is a disorder in which
circulating antibodies directed against an antigen intrinsic
to the glomerular basement membrane (GBM) in the
kidney, thereby resulting in acute or rapidly progressive
glomerulonephritis.
Autoimmune disease
Diseases that occur when the body’s immune system reacts
against the body’s own structures.
B-cells
B-cells, also known as B-lymphocytes, are a type of white
blood cell of the lymphocyte subtype. They are an important
part of the adaptive immune system and secrete antibodies.
Biologics License Application (BLA)
A Biologics License Application (BLA) is submitted to the
Food and Drug Administration (FDA) to obtain permission for
distribution of a biologic product across the United States.
CD20
B-lymphocyte antigen CD20 is a protein expressed on the
surface of B-cells. Its function is to enable optimal B-cell
immune response.
Clinical studies
Investigation of a new drug or treatment using healthy
subjects or patients with the intention to study the efficacy
and safety of a not-yet-approved treatment approach.
Clinical Phase 1
The first time a drug under development is administered to
humans. Phase I studies are often conducted with a small
number of healthy volunteers to assess the safety and
dosing of a not yet approved form of treatment.
Clinical Phase 2
Refers to the first time a drug under development is
administered to patients for the study of safety, dosage and
efficacy of a not yet approved treatment regimen.
Clinical Phase 3
Trials that involve many patients and often continue for a
longer time; they are intended to identify the drug’s effects
and side effects during ordinary but still carefully
controlled conditions.
DSA
Donor specific antibodies. Donor specific antibodies are
antibodies in a transplant patient which bind to HLA and/or
non-HLA molecules on the endothelium of a transplanted
organ, or a potential donor organ. The presence of pre-
formed and de novo (newly formed) DSA, specific to donor/
recipient mismatches are major risk factors for antibody-
mediated rejection.
EMA
The European Medicines Agency (EMA) is a European Union
agency for the evaluation of medicinal products.
Enzyme
A protein that accelerates or starts a chemical reaction
without itself being consumed.
ESOT
The European Society for Organ Transplantation (ESOT) is
an umbrella organization which oversees how
transplantations are structured and streamlined.
FDA
U.S. Food and Drug Administration.
Guillian-Barré syndrome
GBS, Guillian-Barré syndrome, is an acute autoimmune
disease in which the peripheral nervous system is attacked
by the immune system and IgG antibodies.
HBP
Heparin Binding Protein is a naturally occurring protein that
is produced by certain immune cells, i.e. neutrophilic
granulocytes, to direct immune cells from the bloodstream
into the tissues.
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Glossary
continued
HLA
Human Leukocyte Antigen is a protein complex found on the
surface of all cells in a human. The immune system uses
HLA to distinguish between endogenous and foreign.
IgG
IgG, Immunoglobulin G, is the predominant type of antibody
in serum.
Imlifidase
Imlifidase, is the immunoglobulin G-degrading enzyme of
Streptococcus pyogenes, a bacterial enzyme with strict
specificity for IgG antibodies. The enzyme has a unique
ability to cleave and thereby inactivate human IgG antibodies
while leaving other Ig-isotypes intact.
IND
An Investigational New Drug (IND) application is required to
get approval from the FDA to administer an investigational
drug or biological product to humans.
INN
International Nonproprietary Name (INN) is a generic and
non-proprietary name to facilitate the identification of a
pharmaceutical substances or active pharmaceutical
ingredient. Each INN is a unique name that is globally
recognized and is public property. The INN system has
been coordinated by the World Health Organization (WHO)
since 1953.
In vitro
Term within biomedical science to indicate that experiments
or observations are made, for example in test tubes, i.e. in an
artificial environment and not in a living organism.
In vivo
Term within biomedical science to indicate that experiments
or observations are made in living organisms.
IVD
IVD, In vitro diagnostics, are tests that can detect diseases,
conditions, or infections, usually from blood samples or urine
samples. Some tests are used in laboratory or other health
professional settings and other tests are for consumers to
use at home.
Marketing Authorization Application (MAA)
A Marketing Authorization Application (MAA) is an
application submitted to the European Medicines
Agency (EMA) to market a medicinal product in the
EU member states.
Neutralizing Antibodies (NAbs)
NAb is an antibody that defends a cell from a pathogen
or infectious particle by neutralizing any effect it has
biologically.
Pivotal trial
A clinical trial intended to provide efficacy and safety data for
NDA approval at e.g. FDA or EMA. In some cases, Phase 2
studies can be used as pivotal studies if the drug is intended
to treat lifethreatening or severely debilitating conditions.
PRA
Panel Reactive Antibody (PRA) is an immunological
laboratory test routinely performed on the blood of people
awaiting organ transplantation. The PRA score is expressed
as a percentage between 0% and 99%. It represents the
proportion of the population to which the person being
tested will react via pre-existing antibodies.
Preclinical development
Testing and documentation of a pharmaceutical candidate’s
properties (e.g. safety and feasibility) before initiation of
clinical trials.
Randomized Control Trial (RCT)
(RCT) is a study design where the trial subject is randomly
allocated to one of two or more study cohorts to test a
specific intervention against other alternatives, such as
placebo or standard of care. The study participants are
followed up to compare outcomes of different cohorts.
Streptococcus pyogenes
A Gram-positive bacterium that primarily can be found in the
human upper respiratory tract. Some strains can cause
throat or skin infections.
Hansa Biopharma Annual Report 2022
142
Overview
Strategy
Market
Technology
Growth
New
opportunities
Shareholder
information
Directors’ report
Financials
Governance
Remuneration
Hansa Biopharma AB
P.O. Box 785
SE-220 07 Lund, Sweden
Phone: +46 46 16 56 70
E-mail: info@hansabiopharma.com
www.hansabiopharma.com
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