Immunomodulatory enzyme technology pioneers, Hansa Biopharma, expect a fourth-quarter total revenue of SEK 50 million in 2023, with a substantial part originating from Idefirix® sales. An essential revenue boost comes from expanding markets in the U.K., Germany, and Spain. Hansa Biopharma’s business update also includes the announcement of a commercial alliance with NewBridge Pharmaceuticals, aimed at distributing Idefirix® to kidney transplant patients across the Middle East and North Africa. Hansa Biopharma is also making significant strides in clinical developments.
Hansa Biopharma Q4 2023 Business Update
Hansa Biopharma, a trailblazer in immunomodulatory enzyme technology for uncommon diseases impelled by IgG, has issued a business update for 2023’s fourth quarter. The corporation estimates its total revenue for the quarter to reach SEK 50 million. Out of which, SEK 43 million is projected to originate from the sales of their product Idefirix®. The U.K., Germany, and Spain are major contributors to this revenue surge due to market expansion in these nations.
Commercial Partnership with NewBridge Pharmaceuticals
In addition to its financial performance, Hansa Biopharma has formed a commercial alliance with NewBridge Pharmaceuticals. This partnership will facilitate the supply of Idefirix® to kidney transplant patients in the Middle East and North Africa, taking advantage of the existing European conditional marketing authorization and forthcoming approvals for the MENA area.
Progress in Clinical Developments
In the realm of clinical developments, Hansa Biopharma’s ConfIdeS stage 3 trial in the U.S. for kidney transplantation has registered 101 patients to date, with a substantial percentage already randomized. Similarly, the phase 3 trial named GOOD-IDES-02 for anti-GBM disease has enrolled 16 out of the planned 50 patients, with an expected completion date set for 2025. Additionally, a phase 2 trial for ANCA-associated vasculitis, initialized by an investigator, has commenced, enrolling three out of ten patients thus far.
Novel Immunoglobulin Cleaving Enzymes for Repeat Dosing (NICEr) Program
Hansa Biopharma marked a significant milestone with the commencement of the initial human trial for HNSA-5487, a candidate from their Novel Immunoglobulin Cleaving Enzymes for Repeat Dosing (NiceR) program. The potential of HNSA-5487 was observed during the trial, leading the company to conduct further analysis on IgG recovery and immunogenicity to shape future clinical developments. In December 2023, another vital event took place – The beginning of a phase 1b trial of imlifidase, used as a pre-treatment to Sarepta’s SRP-9001 gene therapy for Duchenne Muscular Dystrophy.
Financial Projections for 2023 and Future Milestones
Despite an operating loss of SEK 177 million for the fourth quarter and SEK 790 million for 2023, Hansa Biopharma manages to retain a stable cash standing with SEK 732 million in cash and short-term investments. The company’s key financial goals for 2024 encase high-level data from the Sarepta-linked phase 1b study in DMD and the completion of the randomization process for the U.S. ConfIdeS phase 3 trial. The comprehensive interim report for 2023’s final quarter is set to be publicized on February 2, 2024.
Future Interactions with the Company’s Management
Hansa Biopharma’s management will be accessible for discussions during the J.P. Morgan Conference week from January 8-11, 2024. This business update was derived from a press release statement.
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