Annual and
Sustainability
Reports 2023
Addressing unmet need in rare diseases
We are dedicated to developing and commercializing innovative, lifesaving and life-altering treatments for patients with rare immunological conditions.
Chairman's letter
"As we look ahead to many exciting new milestones, the Board is confident the strong and highly experienced team at Hansa will continue to deliver on its important drug development and commercial priorities."
Peter Nicklin
Chairman, Hansa Biopharma
CEO statement
"We are poised to deliver on our bold ambition of providing life-altering and life-saving medicines to people with rare immunological diseases and conditions."
Søren Tulstrup
President and CEO, Hansa Biopharma
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.
Commercialize IDEFIRIX® in first indication and markets
Successfully launch Hansa's first authorized product IDEFIRIX in Europe.
Secure FDA approval and launch in the U.S.
Geographical Expansion.
Advance ongoing imlifidase clinical programs
Achieve approval/usage of imlifidase in follow-on indications
Broaden the label beyond kidney transplantation.
Expand IgG-cleaving enzyme technology
Expand IgG-cleaving enzyme technology platform into gene therapy.
Develop next generation IgG-cleaving enzymes for repeat usage
Build a focused, integrated, agile and empowered international organization and seek partnerships to accelerate growth and reduce risk
Highlights 2023
Market Access secured in the five largest European markets and in a total of 14 European markets.
Australia is the first country to grant provisional approval in kidney transplantation from both living and deceased donors.
New commercialization agreement for Middle East and North Africa.
Sarepta enters clinical stage with site activated in first clinical trial with imlifidase as a pre-treatment to SRP-9001 gene therapy in DMD.
New collaboration with Généthon to evaluate imlifidase as pre-treatment to gene therapy in Crigler-Najjar syndrome.
Long term data of imlifidase in kidney transplantation confirms sustained benefit through to year 5 (17-HMedIdeS-14).
Encouraging high-level results for first-in-human trial with HNSA-5487 (NICE-01).
Completion of phase 2 trial in Guillain- Barré Syndrome (GBS) and positive safety, tolerability, and early efficacy outcomes in announced (15-HMedIdeS-09).
First patient dosed in the phase 3 trial of imlifidase in anti- GBM disease (GOODIDES-02).
First patient treated in investigator-initiated phase 2 trial in ANCA- associated vasculitis (ImlifidARDSe.01).
Financed into 2025.
Market cap of approximately 132m USD (Dec. 2023).
Country-specific medical guidelines created in five countries across Europe following the publication in 2022 by ESOT of the first set of clinical guidelines on a management pathway for highly sensitized patients.
Awarded Great Place to Work for the fourth consecutive year by the independent institute Great Place to Work® and selected among the best workplaces in Sweden in 2023.
Potential indication universe
Hansa's first-in-class immunoglobulin G (IgG) antibody cleaving enzyme technology has significant potential in several therapeutic indication where IgG become harmful or interfere with and undermine the success of a therapy.
The potential of IgG Modulation in autoimmune indications
Autoimmune diseases are caused by the immune system mistakenly mounting an immune attack against the body’s own cells and tissues. Hansa’s technology platform may have relevance in several autoimmune diseases where IgGs play an important role in the pathogenesis, and its action is being investigated in clinical settings in the treatment of rare autoimmune conditions.
Bridging the access to gene therapies for more patients
Sometimes, a perfectly functional immune system can have detrimental effects for a patient in need of treatment, like in the case of AAV-based gene therapies. We see the potential for our enzymes to help overcome the immunological barrier created by pre-existing neutralizing antibodies (NAbs), thereby enabling effective transfer of a healthy gene sequence into these patients.
Advancing the science of incompatible kidney transplantation
There remains an urgent need to ensure highly kidney tranbsplant sensitized patients have access to high quality care and guideline directed desensitization strategies to enable them to receive a life-changing kidney transplant. As innovations in desensitization become more readily available Hansa continues to advance the science around desensitization.
Ushering in innovative solutions in IgG-cleaving technology
Hansa is expanding its IgG cleaving platform beyond its lead molecule, imlifidase, with HNSA-5487. Part of the NiceR program (Novel Immunoglobulin Cleaving Enzymes for Repeat dosing), HNSA-5487 is the first next-generation IgG-cleaving enzyme designed to treat conditions where there is a need to prolong the IgG-low window through re-dosing.
Sustainability Report
2023
Becoming a more sustainable business
"The continued success of Hansa hinges on more than the results we achieve. It is also about how we deliver them."
Søren Tulstrup
President and CEO, Hansa Biopharma
Our Sustainability strategy
Hansa is committed to addressing unmet need by advancing innovative science and ensuring access to lifesaving and life-altering medicines. Our strategy ensures we are addressing the most relevant topics to our business and meet the expectations of external and internal stakeholders.
At Hansa, we have identified where we can positively contribute to the United Nations’ Sustainable Development Goals.
Addressing unmet medical needs
Ensuring equitable access to care is work we cannot do alone and requires a multi-stakeholder approach. Throughout 2023, Hansa engaged with key patient advocacy across the US and Europe to understand the needs of patients in kidney transplantation, rare disease, and autoimmune disease.
Cultivating an engaged culture by fostering inclusivity, collaboration, and innovation
As a growing biotech company with employees around the globe, we are focused on ensuring we cultivate an inclusive and diverse culture, enable employees to develop and grow, and offer a healthy and safe work environment.
Making a difference by operating an ethical, transparent, and responsible business
Hansa is committed to operating with the highest integrity and ethical standards complying with laws and regulations and driving personal accountability for employees, partners, and vendors.
Embracing sustainable decision-making and environmental stewardship
As we grow as a company, we should strive to keep our environmental impact small. This means utilizing approaches that create a default sustainable business from discovery to clinical trial design, to product launches and manufacturing.
Addressing unmet medical needs
Ensuring equitable access to care is work we cannot do alone and requires a multi-stakeholder approach. Throughout 2023, Hansa engaged with key patient advocacy across the US and Europe to understand the needs of patients in kidney transplantation, rare disease, and autoimmune disease.
Cultivating an engaged culture by fostering inclusivity, collaboration, and innovation
As a growing biotech company with employees around the globe, we are focused on ensuring we cultivate an inclusive and diverse culture, enable employees to develop and grow, and offer a healthy and safe work environment.
Making a difference by operating an ethical, transparent, and responsible business
Hansa is committed to operating with the highest integrity and ethical standards complying with laws and regulations and driving personal accountability for employees, partners, and vendors.
Embracing sustainable decision-making and environmental stewardship
As we grow as a company, we should strive to keep our environmental impact small. This means utilizing approaches that create a default sustainable business from discovery to clinical trial design, to product launches and manufacturing.
2023 sustainability performance highlights
32
Different nationalities
100%
Renewable electricity used
52%
Women in senior position
100%
Completion rate Great Place To Work Survey