Biogen Inc (BIIB)

Earnings Growth Outlook
Q: Is 2023 the earnings trough; what ensures growth ahead?
A: Michael McDonnell affirmed that Biogen aims for sustainable top and bottom-line growth. The company is pleased with the 2024 guidance, raising non-GAAP EPS growth to 9% at the midpoint ( - ). He highlighted the stabilizing top line and the focus on cost savings programs that improve operating performance and free up capital for growth initiatives ( - ). Biogen is confident that 2023 was the trough year and is focused on new product launches and the durability of the MS franchise to drive growth ( - ).

LEQEMBI EMA Decision
Q: Will you appeal the EMA's negative opinion on LEQEMBI?
A: Priya Singhal expressed disappointment with the EMA's negative opinion on LEQEMBI but affirmed plans to request a reexamination ( - ). She emphasized that they believe in LEQEMBI's favorable benefit-risk profile, which has been approved in major regions like the United States, China, and Japan ( - ). The reexamination process involves submitting additional data, including long-term and real-world evidence, to address the EMA's concerns, aiming for a potentially faster outcome than the original application ( - ).

Business Development Strategy
Q: What's your appetite for large acquisitions like Reata?
A: CEO Chris Viehbacher stated that Biogen is open to acquisitions similar to Reata but is disciplined and not desperate to do deals ( - ). The focus is on areas where Biogen has strong capabilities, such as immunology and rare diseases, avoiding competitive auctions to prevent overpaying ( - ). He highlighted that Biogen's size allows it to consider assets that may be too small for larger companies but significant for Biogen, aiming to create shareholder value through smart capital deployment ( - ).

LEQEMBI Subcutaneous Dosing
Q: Any updates on LEQEMBI subcutaneous dosing option?
A: Priya Singhal reported that they continue to work on the subcutaneous formulation of LEQEMBI, with a rolling submission in place and a goal to potentially accelerate proof-of-concept outcomes ( - ). They are collaborating with the FDA, aiming for an outcome by Q1 2026 ( - ). Regarding the EMA application, the subcutaneous option may not directly impact the current reexamination process, which focuses on intravenous LEQEMBI ( - ).

Physician Feedback on LEQEMBI
Q: Are physicians showing less favorable views on LEQEMBI?
A: Alisha Alaimo stated that they are not experiencing pushback from physicians regarding LEQEMBI's risk-benefit or cost-benefit ratios ( - ). She emphasized that physicians prescribing LEQEMBI understand the data and are actively working to get patients treated, indicating strong conviction in the therapy's importance ( - ). CEO Chris Viehbacher added that the increasing number of prescribing physicians and depth of ordering suggest growing confidence and commitment to LEQEMBI ( - ).

Lupus Portfolio Expectations
Q: What are your expectations for upcoming lupus data?
A: Priya Singhal expressed excitement about the upcoming readout for dapirolizumab (DAP) in systemic lupus erythematosus (SLE) ( - ). The Phase III trial investigates safety and efficacy over 48 weeks, aiming for meaningful changes on primary endpoints and acceptable safety profiles ( - ). If results are positive, they expect to run another Phase III study, with planning already underway ( - ).

SKYCLARYS Patient Persistence
Q: How is patient persistence with SKYCLARYS?
A: Alisha Alaimo reported that discontinuation rates for SKYCLARYS are consistent with clinical trials, and patients tend to stay on therapy ( - ). Physicians set appropriate expectations, advising patients to stay on treatment for at least a year ( - ). They are past the catch-up population and are now in the patient identification phase, using AI tools to identify additional patients, which is promising for growth ( - ).

Company Challenges Ahead
Q: What challenges remain for Biogen?
A: CEO Chris Viehbacher acknowledged ongoing challenges, including potential biosimilar competition for TYSABRI and important patent litigation for TECFIDERA in Europe ( - ). He emphasized the company's strong scientific and medical capabilities, focusing on smart capital deployment, and transforming passive capital into active growth opportunities ( - ). Biogen aims to build its R&D portfolio internally and externally to drive future growth ( - ).

Angelman Syndrome Program
Q: Why did you opt out of the Angelman program with Ionis?
A: Priya Singhal explained that Biogen employs disciplined decision-making based on data readouts and predefined go/no-go criteria ( - ). After evaluating the BIIB121 data, they decided not to continue investment due to the assessment of the probability of technical and regulatory success ( - ). The focus remains on programs with compelling data and established regulatory pathways ( - ).