Release Date: October 17, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Hansa Biopharma AB (STU:24H, Financial) achieved its highest ever quarterly IDEFIRIX sales in Q3 2024, marking the fourth consecutive quarter of solid sales performance.
- The company has secured reimbursement in 15 European markets, covering approximately 75% of the European transplant market.
- Significant scientific advancements were made, including the completion of patient randomization in the US phase three trial for kidney transplantation.
- The company is progressing well with its pipeline, including the Good-IdeS-12 Phase 3 trial in anti-GBM disease, which is 86% enrolled.
- Hansa Biopharma AB (STU:24H) has a strong financial position with cash and cash equivalents totaling SEK554 million as of September 30, 2024.
Negative Points
- A provision of SEK29.7 million was recorded in Q3 2024 due to a revised estimate of a one-time retroactive adjustment of cumulative sales since launch in 2020.
- SG&A expenses remain high, totaling SEK76 million in Q3 2024, despite restructuring efforts.
- R&D expenses are significant, totaling SEK79.6 million in Q3 2024, reflecting ongoing clinical trial activities.
- The company faces challenges in pricing negotiations, as evidenced by the need for provisions related to early access programs.
- There is uncertainty regarding the next steps for the AMR program following phase two data, with no immediate plans for a phase three trial.
Q & A Highlights
Q: The GBS phase two data for the match cohort seems delayed. What caused this, and what do you hope to see in the readout to move towards a phase three trial?
A: We are on track with the guidance for a second-half readout. We hope to see a speedy recovery in key functional parameters compared to patients treated with IVIG only.
Q: With the GBM phase three recruitment progressing well, how should we think about the next steps and the company's capacity to handle two filings and launches simultaneously?
A: We are excited about the potential to submit a BLA for this indication. We are moving forward quickly with enrollments and will ensure we have the resources to prioritize these indications.
Q: Can you comment on your R&D spending plans for 2025-2026, considering your high clinical activity and future plans with HNSA-5487?
A: We plan to initiate new clinical trials with HNSA-5487 while concluding two phase three trials. This will balance new clinical activities with those being concluded.
Q: Regarding a potential competitor, Seismic Therapeutic, which targets both acute and chronic settings in autoimmune diseases, what's your view on this?
A: It's good to see more players in this space. We see opportunities in both acute and chronic settings and are initially focusing on acute phases but recognize potential in chronic management as well.
Q: Does the provision taken for IDEFIRIX imply larger discounts in negotiations, and does it affect future pricing?
A: The provision relates to converting an early access program into full reimbursement, which is positive. We expect pricing to reflect the value we bring, and this is a one-time event.
Q: The recruitment for the anti-GBM trial is faster than expected. Is there greater enthusiasm or a higher incidence than previously thought?
A: The rapid enrollment reflects the severity of the condition and the high desire from centers to participate. The disease has severe outcomes, encouraging centers to enroll patients.
Q: Does setting a final reimbursement price in one market affect reference pricing in other countries?
A: We are within the expected range and pleased with the coverage and pricing negotiated across Europe. We are preparing for the US launch, which will involve building infrastructure.
Q: What are the next steps for the AMR program following phase two data, and are you seeking partnerships for a phase three trial?
A: We are thrilled with the phase two results but have not determined specific next steps for a phase three trial. The data is encouraging, but a phase three trial would require a large study.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
