Annual Report 2024
Sustainability Report 2024

Science-led
Patient first
Values driven

We are on a mission is to deliver innovation to people living with immune-mediated diseases

Read the Annual Report 2024

Read the Sustainability Report 2024

Chairman's letter

"In my third year as Chairman of the Board of Directors, I’m excited for what’s to come. Hansa remains on track to advance innovative science and deliver important new medicines to the patients who need it most."

Peter Nicklin
Chair of the Board, Hansa Biopharma

CEO statement

"2024 was a momentum-building year for Hansa that has positioned us well to advance our efforts in Autoimmune, Gene Therapy and Transplantation."

Søren Tulstrup
President and CEO, Hansa Biopharma

Strategic priorities

Hansa’s mission is to leverage our unique immunomodulating technology platform to develop innovative, lifesaving and life altering treatments for people with rare immunological conditions, ensure fair and equitable access to these medicines, and generate value to society at large.

Commercialize IDEFIRIX^® (imlifidase)

Successfully launch IDEFIRIX^® in Europe

Secure FDA approval and launch in the U.S.

Geographic expansion

Advance ongoing imlifidase clinical programs

Achieve approval/usage of imlifidase in follow-on indications

Broaden the IDEFIRIX^® label beyond kidney transplantation into areas of high unmet need in Autoimmunity and Gene Therapy

Expand IgG-cleaving enzyme technology

Advance HNSA-5487, the Company’s next generation IgG-cleaving enzyme with redosing potential, into neuroautoimmunity including myasthenia gravis (MG)

Evolve the organization into a global, commercial stage biopharmaceutical company and seek partnerships to accelerate growth and reduce risk

Highlights 2024

Commercialization

Market Access secured in the five largest European markets and in a total of 18 European markets.

Record full year sales of 189.7 MSEK

Record quarterly sales of 69.5 MSEK in the third quarter of 2024

Partnerships

Sarepta initiated a Phase 1b clinical trial (SRP-9001-104) evaluating the use of imlifidase as pre-treatment ahead of Sarepta’s gene therapy in DMD.

Genethon initiated a Phase 2 clinical trial (GNT-018IDES) evaluating the efficacy and safety Genethon’s gene therapy GNT-0003 following pre-treatment with imlifidase in patients with severe Crigler-Najjar syndrome.

Clinical advancement

Full results of the NICE-01 first in human trial and 12-month follow up analysis of HNSA-5487, the Company’s next generation IgGcleaving molecule with redosing potential.

Completed randomization of Hansa’s pivotal Phase 3 trial (ConfIdeS), evaluating imlifidase as potential desensitization therapy to enable kidney transplantation in highly sensitized patients.

Positive full results from the 15-HMedIdeS-09 single arm Phase 2 study of imlifidase in GBS and an indirect treatment comparison of the 15-HMedIdeS-09 study data to the International Guillain Barré Syndrome Outcome Study (IGOS).

Completion of enrolment of the GOOD-IDES-02 Phase 3 trial in anti-GBM disease.

Financial position

SEK ~372m (USD ~34.6m) raised in a directed share issue in April 2024.

Cash runway into 2026.

Improving overall kidney transplant patient outcomes

New International guidelines published in Transplant International on appropriate use of imlifidase in clinical practice to enable kidney transplants in highly sensitized patients.

In 2024, 53 patients eligible for IDEFIRIX® were identified by transplant centers in countries participating in Eurotransplant’s Desensitization Program.

Real-world evidence on use of imlifidase in highly sensitized kidney transplant published in Kidney International Reports in July 2024 and presented at the American Society of Transplantation’s annual congress in June 2024.

A Great Place to Work since 2020

Awarded Great Place to Work in 2024 (for the fifth consecutive year) by the independent institute Great Place to Work®.

Key therapy areas

Hansa is developing novel immunomodulating biologic therapies based on a proprietary, first-in-class IgG cleaving platform.

Autoimmune

Autoimmune diseases have a significant impact on the individuals and families they affect. As their frequency and prevalence grow and more autoimmune diseases are identified, they impact the life of a growing proportion of the population, with associated growing costs for healthcare systems.

Our first-generation IgG immunoglobulin G (IgG) antibody cleaving enzyme, could potentially address IgG-driven autoimmune diseases and conditions, while our next-generation enzyme with its redosing potential could play an important role in autoimmune diseases where there is a need for better management of initial and repeat immune system attacks.

Gene therapy

For people living with one of the approximately 7,000 known rare, monogenic diseases, gene therapies may offer a cure to a life-long condition by introducing genetic material that compensates for a defective gene. However, if the therapy is based on the use of Adeno Associated Virus (AAV) vectors, the immune system may carry antibodies that counteract the gene therapy treatment preventing its success.

We partner closely with cutting edge gene therapy companies to advance the scientific understanding of how Hansa’s proprietary IgG-cleaving technology may have the potential to help overcome the immunological barrier to treatment created by anti-AAV antibodies, and enable these potentially life-saving treatments for more patients.

Transplantation

End stage renal disease (ESRD) or kidney failure is a serious, progressive, often-times fatal disease, affecting nearly 2.5 million patients worldwide. Receiving a transplant is life-changing, and the treatment of choice for ESRD. Among the people waiting for a donor kidney, those considered highly sensitized face unique challenges that can result in inequitable access to donor organs and transplantation and extended time on dialysis.

Hansa continues to advance the science around desensitization to help ensure equitable access to care for highly sensitized kidney transplant patients.

Read the Annual Report 2024

Sustainability Report 2024

Hansa's
Sustainability
Journey

Read the Sustainability Report 2024

“With a keen eye towards becoming a more sustainable, ethical and transparent organization, Hansa has the opportunity to deliver innovative new medicines to people in areas with high unmet need.”

Søren Tulstrup
President and CEO, Hansa Biopharma

Our Sustainability strategy

Our sustainability strategy ensures we are addressing the most relevant topics to our business and meet the expectations of external and internal stakeholders. We aim to act as a responsible business that plays an important role in society and strives to have a positive impact on the communities where we operate.

1. Addressing unmet medical needs

2. Cultivating an engaged culture by fostering inclusivity, collaboration, and innovation

3. Embracing sustainable decision-making and environmental stewardship

4. Making a difference by operating an ethical, transparent,
and responsible business

At Hansa, we have identified where we can positively contribute to the United Nations’ Sustainable Development Goals. 