Release Date: October 30, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Biogen Inc (BIIB, Financial) reported a 66% growth in global revenue for LEQEMBI in the third quarter compared to the second quarter, with significant uptake outside the US, particularly in Japan.
- The company has made substantial progress in reducing its cost base and embedding a value-for-money approach to spending.
- Biogen Inc (BIIB) has a strong late-stage pipeline with potential peak sales of about $14 billion, which could transform the company over the longer term.
- The SKYCLARYS launch is progressing well, generating revenue in 15 countries outside the US, with increased demand quarter-over-quarter.
- ZURZUVAE outperformed expectations in the US, with a 49% increase in revenue over the second quarter, driven by a 40% increase in patients.
Negative Points
- LEQEMBI revenue in the US continues to be below expectations, with the prescriber base not expanding as anticipated.
- Biogen Inc (BIIB) experienced a 9% decline in MS product revenue, primarily due to competitive dynamics and channel issues.
- Global SPINRAZA revenue declined by 15%, impacted by the loss of an annual tender in Russia and timing of shipments.
- The company faces challenges in the European market with pricing and reimbursement dynamics affecting SKYCLARYS revenue.
- Biogen Inc (BIIB) anticipates further challenges to its TECFIDERA-related patent, despite a favorable decision from the European Patent Office.
Q & A Highlights
Q: On LEQEMBI, when might you expect to see more pull-through from the expanded commercial efforts, and can you expand on potential commercial acceleration strategies?
A: Christopher Viehbacher, CEO, explained that the launch has been complex, with significant learning over the past year. The company is working closely with Eisai to refine strategies, including the potential introduction of a subcutaneous formulation and more use of blood-based diagnostics. Alisha Alaimo, President of North America, added that the new field force is starting to show results, with increased prescriber engagement and patient access.
Q: Could you provide an update on the status of the subcutaneous filings for LEQEMBI, both for maintenance and induction?
A: Priya Singhal, Head of Development, stated that the subcutaneous maintenance filing is imminent, with regulatory outcomes expected by Q1 2026 for the initiation therapy. The data is being generated and analyzed as part of the Clarity open-label extension study.
Q: Can you comment on the pricing and reimbursement dynamics for SKYCLARYS in the US?
A: Christopher Viehbacher, CEO, explained that revenue generation in Europe is affected by country-specific reimbursement negotiations. While patient demand is strong, revenue recognition will be lumpy due to the timing of these negotiations and early access program pricing adjustments.
Q: What are your updated thoughts on business development strategy moving forward?
A: Christopher Viehbacher, CEO, emphasized the focus on finding assets that enhance near-term revenue growth while creating shareholder value. The company is actively looking for opportunities in both public and private sectors, with a disciplined approach to ensure a good return on investment.
Q: Can you discuss the potential impact of the AHEAD 3-45 study completion on Alzheimer's treatment?
A: Priya Singhal, Head of Development, highlighted the completion of enrollment in October, with trials focusing on early and intermediate stages of amyloid. The study aims to provide insights into early treatment benefits, with ongoing engagement with regulators to determine potential readout timelines.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
