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Hansa Biopharma year-end report 2021

Regulatory information

· Commercial launch and market access efforts in Europe progressing as planned; new multiregional commercialization partnership with Medison Pharma 
· First patients enrolled into the pivotal U.S. ConfIdeS study
· Agreement established with AskBio to evaluate feasibility of imlifidase as pre-treatment ahead of gene therapy in Pompe disease
· Platform strategy: Hansa to explore desensitization treatment in allogeneic hematopoietic stem cell transplantation
· Year-end cash position of SEK 889 million; Hansa financed into 2023, as previously guided

Lund, Sweden February 3, 2022 Hansa Biopharma, the pioneer in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and year-end report for 2021.

Highlights for the fourth quarter 2021

  • Commercial launch and market access efforts for Idefirix® in Europe are progressing as planned. Reimbursement has been secured in Sweden and the Netherlands, as well as on an individual hospital basis in Finland and Greece.
  • Market access procedures are ongoing in 14 countries including Germany, France, Italy and the United Kingdom (U.K.). A Health Technology Assessment (HTA) dossier for Spain was submitted in January 2022, which completes HTA filings in all of the five largest markets in Europe.
  • In December 2021, Hansa and Medison Pharma announced a multiregional commercialization partnership for Idefirix® for kidney transplantion covering Israel and major countries in the Central Eastern European region.
  • The first patients in the pivotal U.S. open-label, randomized, controlled trial “ConfIdeS,” were enrolled at the Columbia University Medical Center, New York during December 2021.
  • Clinical pipeline update: In the Antibody Mediated Rejection (AMR) trial, 23 patients out of a target of 30 patients have been enrolled, and in the Guillain Barré Syndrome (GBS) trial 15 patients out of a target of 30 patients have been enrolled as of February 2 2022. The widespread impact of the COVID-19 pandemic and the emergence of the Omicron variant have impacted the availability of staff across a number of trial centers. Additionally, a shortage of IVIg has affected the enrollment rate at a subset of participating hospitals in our GBS program. Given the current difficulty of predicting enrollment due to the direct and indirect effects of the continued pandemic and increased infection rates due to omicron, Hansa expects to update its guidance related to the GBS timelines in April, in connection with the publication of its Q1 report. In the meantime, in order to support mitigating these hurdles, Hansa has simplified the study protocol, is actively supporting the hiring of additional staff at the clinics and is adding two sites for the recruitment of patients in the U.K. and the Netherlands.
  • Plans to initiate a Phase 3 study of imlifidase to treat anti-Glomerular Basement Membrane (anti-GBM) disease were announced in November 2021, after a successful pre-IND meeting with the U.S. FDA. The planned pivotal Phase 3 clinical study will enroll approximately 50 patients with anti-GBM disease across the U.S. and Europe. The first patient is expected to be enrolled in 2022.
  • Partnership with Sarepta and preclinical collaboration with argenx moving forward according to plan.

Events after the reporting period

  • On January 3, 2022, Hansa entered into an agreement with AskBio to evaluate the potential use of imlifidase as a pre-treatment prior to the administration of AskBio’s investigational gene therapy in Pompe disease in a pre-clinical and clinical feasibility program for patients with pre-existing neutralizing antibodies (Nabs). Upon execution, Hansa receives a USD 5 million payment, while AskBio has an exclusive option to negotiate a full development and commercialization agreement.
  • On January 9, 2022, Hansa announced that it intends to explore the potential development of imlifidase in allogeneic hematopoietic stem cell transplantation (HSCT), also known as “bone-marrow transplantation”.

Financial summary

  • Cash position of SEK 889m at the end of December 2021, expected to fund Hansa’s operations into 2023.
  • Investments in R&D in the fourth quarter amounted to SEK 68m (Q4’20: SEK 50m) and to SEK 231m for the full year of 2021 (full year ’20: SEK 227m). SG&A expenses amounted to SEK 103m in Q4 2021 (Q4’20: SEK 63m) and to SEK 327m for the full year 2021 (full year ’20: SEK 203m), in line with plans.
  • Cash flow from operating activities for the fourth quarter of 2021 was SEK -116m (Q4 ’20: SEK -97m) and SEK -481m for the full year 2021 (full year ’20: -290m).
SEKm, unless otherwise stated – unaudited Q4 2021 Q4 2020 12M 2021 12M 2020
Revenue 15.4 3.8 33.9 6.1
SG&A expenses -103.2 -63.2 -327.3 -203.0
R&D expenses -68.2 -50.4 -230.8 -227.2
Operating profit/loss -162.8 -106.2 -547.0 -422.8
Net profit/loss -163.4 -105.8 -548.3 -420.9
Cash flow from operating activities -116.3 -96.5 -481.2 -290.3
Cash and short-term investments 889.0 1,377.5 889.0 1,377.5
Shareholders’ equity 757.6 1,242.1 757.6 1,242.1
EPS before and after dilution (SEK) -3.67 -2.38 -12.33 -9.98
Number of outstanding shares 44,473,452 44,473,452 44,473,452 44,473,452
Weighted avg. number of shares before and after dilution 44,473,452 44,473,452 44,473,452 42,176,872
Number of employees at the end of the period 133 87 133 87

Søren Tulstrup, President and CEO of Hansa Biopharma, comments

“2021 was, overall, a transformative and successful year for Hansa Biopharma as the Company advanced into a fully integrated, commercial-stage biopharmaceutical company following the commercial launch in Europe of Idefirix® (imlifidase), labeled for desensitization of highly sensitive kidney transplant patients incompatible to a deceased donor.

From a strategic point of view, we have executed throughout the year on our key priorities, including meeting our R&D, commercial and organizational objectives. In addition, I am very encouraged to see the high level of interest from other healthcare companies to partner with Hansa. During the last 12 months, the Company has entered into three new collaborations, which serves as further validation of the potential of our unique IgG-cleaving enzyme technology platform.

Hansa’s mission is to leverage this technology to develop innovative, lifesaving and life-altering immunomodulating therapies, bring these to the patients with rare diseases and conditions who need them and generate value to society at large. To achieve this mission, we are building a high-performance team by attracting and integrating the most talented and experienced candidates, while creating a rewarding, productive and stimulating workplace for our employees. The progress we are making was again evidenced in 2021 as we received certification as aGreat Place to Workfor the second consecutive year by the GPTW Institute.

On the operational side, we have seen solid execution in expanding our market access and geographical footprint in Europe. Pricing and reimbursement have been secured in Sweden and the Netherlands, as well as on a hospital basis in Finland and Greece. Market access procedures are now ongoing in 14 countries including Spain, which was submitted in January this year. Hansa has now submitted in all the five largest markets in Europe, which is an important milestone as we build the foundation for Idefirix®, our potentially transformative therapy that is bringing hope to the thousands of highly sensitized patients across the continent, currently waiting for a compatible kidney transplant. Looking beyond the early launch countries, I was also pleased that we could announce a multiregional commercialization partnership with Medison Pharma for Hansa’s desensitization treatment for kidney transplant in Central Eastern Europe and Israel. Medison is a recognized international pharma company focused on providing access to highly innovative therapies to patients in international markets, and this commercial partnership represents an important milestone for Hansa as we expand access to Idefirix® beyond initial markets for highly sensitized patients awaiting kidney transplants.

In the U.S., we announced that the first patients in our pivotal ConfIdeS trial in kidney transplantation were enrolled at the Columbia University Medical Center, New York. 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 enroll patients at 12-15 leading transplantation centers across the U.S., with the aim of completing enrollment by the end of this year. We believe that the U.S. trial will generate valuable experience at these key centers while also generating important data.

In gene therapy, we were excited to announce an agreement with AskBio, a subsidiary of Bayer AG, 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). Nabs against adeno-associated virus used in gene therapies remain a major challenge and we see significant potential for our antibody-cleaving enzyme technology to help overcome this barrier. The new collaboration with AskBio marks another key step in the implementation of our partnership strategy in the gene therapy space.

Turning to our ongoing Phase 2 programs for GBS and AMR, we have enrolled 23 out of a target of 30 patients in the AMR study while 15 out of a target of 30 patients have been enrolled in the GBS study as of February 2, 2022.

In regards to our GBS program we see how the impact of the COVID-19 pandemic and the emergence of the Omicron variant have affected the availability of staff across a number of trial centers. Additionally, a shortage of IVIg has affected the enrollment rate in the GBS program at a subset of participating hospitals. Given the current difficulty of predicting enrollment due to the direct and indirect effects of the continued pandemic and increased infection rates due to omicron, Hansa expects to update its guidance related to the GBS timelines in April, in connection with the publication of its Q1 report. In the meantime, in order to support mitigating these hurdles, Hansa has simplified the study protocol, is actively supporting the hiring of additional staff at the clinics and is adding two sites for the recruitment of patients in the U.K. and the Netherlands.

In anti-GBM disease, Hansa recently announced plans to initiate a Phase 3 study of imlifidase , following a successful pre-IND meeting with the U.S. FDA. The planned pivotal study will enroll approximately 50 patients with anti-GBM disease across the U.S. and Europe, with the first patient expected to be enrolled in 2022.

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 and conditions, the Company is exploring new indications with a high unmet need. One of the indications Hansa intends to explore further is allogeneic hematopoietic stem cell transplantation (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 for managing these patients. Imlifidase may have the potential to transform the standard of care by enabling clinicians to inactivate DSAs prior to transplantation so as to create the basis for successful transplantation.

An exciting year lies ahead of us with many potential milestones to be achieved across our platform and many indication areas. I look forward to updating you on our progress.”

Upcoming milestones and news flow

H1’22                  AMR Phase 2 study: Complete enrollment 

Under review      GBS Phase 2 study: Complete enrollment (Due to COVID Hansa expects to update its guidance in April 2022)

2022                   NiceR: Completion of GLP tox studies

2022                   Anti-GBM:  Initiation of phase 3 study

H2 2022             Kidney transplantation US: Complete enrollment

H2 2022             AMR Phase 2 study: First data read out

Under review     GBS Phase 2 study: First data read out (Due to COVID Hansa expects to update its guidance in April 2022)

2023                   Long-term follow-up data 5-years out in kidney transplantation

H2 2023             Kidney transplantation US: complete 12 months follow-up

H1 2024             Kidney transplantation US: BLA submission

Conference call details

Hansa Biopharma will host a telephone conference today Thursday February 3 14:00 CET / 8:00am EST.

The presentation will be held in English and be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota. Slides used in the presentation will be live on the company website during the call under ”Events & Presentation” and will also be made available online after the call.

To participate in the telephone conference, please use the dial-in details provided below:

Sweden: +46 850 55 83 51

United Kingdom: +44 333 300 92 60

United States: +1 646 722 49 56

The webcast will be available on https://streams.eventcdn.net/hansa/q4-2021/

The interim report and latest investor presentation can be downloaded from our web

Year-end report 2021

https://investors.hansabiopharma.com/English/financial-data/quarterly-report/default.aspx

Investor road show presentation Q4, 2021

https://investors.hansabiopharma.com/English/events-and-presentations/presentations/default.aspx

This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act.