Hansa Biopharma Reports Strong Q4 Revenue Growth and Expansion into New Markets
Hansa Biopharma, a leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, has announced impressive results for the fourth quarter of 2023. The company expects to report total revenue of SEK 50 million, with SEK 43 million stemming from sales of its product Idefirix®. This surge in revenue is primarily due to market growth in the U.K., Germany, and Spain. This achievement reflects the success and increasing demand for Hansa Biopharma’s innovative therapeutic solutions.
Commercial Partnership with NewBridge Pharmaceuticals Expands Hansa’s Reach in the MENA Region
In a notable development, Hansa Biopharma has entered into a commercial partnership with NewBridge Pharmaceuticals to supply its flagship product, Idefirix®, to kidney transplant patients in the Middle East and North Africa (MENA) region. Leveraging its existing European conditional marketing authorization and pending approvals in the MENA region, this strategic alliance will allow Hansa Biopharma to expand its reach and provide much-needed treatments to patients in a new market. This collaboration further solidifies Hansa Biopharma’s position as a global leader in immunomodulatory enzyme technology.
Updates on Clinical Trials: Positive Results for HNSA-5487 and Promising Data for Imlifidase in DMD
Hansa Biopharma has made significant progress in its clinical trials during the fourth quarter of 2023. The company’s US ConfIdeS phase 3 trial for kidney transplantation has already enrolled 101 patients, with a significant portion already randomized. This trial aims to evaluate the efficacy and safety of Idefirix® in kidney transplant patients, with promising initial results.
In addition, the GOOD-IDES-02 phase 3 trial for anti-GBM disease has enrolled 16 of the targeted 50 patients, with completion expected in 2025. This trial will provide valuable insights into the potential of Idefirix® for the treatment of this rare disease.
Moreover, an investigator-initiated phase 2 trial in ANCA-associated vasculitis is currently underway, with 3 out of 10 patients already enrolled. This trial will evaluate the efficacy and safety of Idefirix® in patients with this challenging disease.
Another significant milestone for Hansa Biopharma is the initiation of the first-in-human trial for HNSA-5487. This candidate from the Novel Immunoglobulin Cleaving Enzymes for Repeat Dosing (NiceR) program has shown promising results in the initial stages of the trial. Further analysis on IgG recovery and immunogenicity is being conducted to inform future clinical development.
Furthermore, in December 2023, a phase 1b trial of imlifidase as a pre-treatment to Sarepta’s SRP-9001 gene therapy in Duchenne Muscular Dystrophy (DMD) began. This trial aims to evaluate the safety and potential synergistic effect of imlifidase in combination with gene therapy, potentially opening new avenues for the treatment of DMD.
Preliminary Financials Show Operating Loss for Q4, but Strong Cash Position for Hansa Biopharma
In terms of financial performance, Hansa Biopharma reported an operating loss of SEK 177 million for the fourth quarter of 2023 and a total loss of SEK 790 million for the year. Research and development expenses reached SEK 411 million. Despite these losses, the company maintains a solid cash position, with SEK 732 million in cash and short-term investments as of December 31, 2023. This financial stability positions Hansa Biopharma well for future growth and continued investment in its innovative pipeline.
Key Milestones for 2024: High-Level Data Readout for DMD Study and Completion of US ConfIdeS Trial
Looking ahead to 2024, Hansa Biopharma has set key milestones for its clinical trials. The company expects to announce the first high-level data readout from the phase 1b study of imlifidase as a pre-treatment to gene therapy in DMD. This readout will provide important insights into the safety and efficacy of this combination therapy approach.
Additionally, the completion of randomization for the US ConfIdeS phase 3 trial is expected. This trial aims to evaluate the efficacy and safety of Idefirix® in kidney transplantation. The completion of randomization will be a significant milestone and will pave the way for the final analysis of the trial results.
These milestones highlight Hansa Biopharma’s commitment to advancing innovative treatments for rare IgG-mediated diseases and its dedication to improving the lives of patients worldwide. With its strong financial position and promising clinical developments, Hansa Biopharma is well-positioned for future success and growth in the field of immunomodulatory enzyme technology.
Analyst comment
Positive news:
Hansa Biopharma reports strong Q4 revenue growth and expansion into new markets, with impressive results and increasing demand for its therapeutic solutions. Commercial partnership with NewBridge Pharmaceuticals expands reach in the MENA region. Positive results in clinical trials and progress in research show promising potential for the company’s innovative treatments. Despite operating losses, Hansa Biopharma maintains a solid cash position for future growth. Key milestones for 2024 include high-level data readout for DMD study and completion of US ConfIdeS trial. With its financial stability and promising developments, the market expects future success and growth for Hansa Biopharma in the field of immunomodulatory enzyme technology.
