Q4 2023 Earnings Summary
- SPINRAZA shows signs of returning to growth: Despite competition from oral therapies and gene therapies, SPINRAZA is stabilizing and moving back toward a modest growth trajectory. Biogen is targeting adult SMA patients, where only about 30% of patients with SMA are actually treated, and is developing a high-dose SPINRAZA program that could improve patient convenience and competitiveness.
- SKYCLARYS has significant growth potential: SKYCLARYS has over 20% of the potential patient population on therapy within about 6 months of launch in the U.S. Biogen is working with the Friedreich’s Ataxia Research Alliance to identify patients and making genetic tests more available. European approval has been granted, and global expansion is underway.
- Promising pipeline in Angelman Syndrome and Lupus: Biogen's BIIB121 program for Angelman Syndrome may have competitive advantages due to its unique ASO backbone and dosing schedule, with dosing potentially needed at a quarterly level. The company expects midyear data that could lead to a pivotal study. Additionally, the Phase III lupus program (dapirolizumab pegol) is appropriately powered and positioned to provide a clear readout on therapeutic potential, with results expected mid-2024.
- SPINRAZA is facing increasing competition from oral therapies and gene therapies, which may affect its ability to return to growth.
- SKYCLARYS's growth is expected to moderate in 2024 due to complexities in patient identification, diagnosis, and reimbursement processes, potentially impacting its contribution to revenue growth.
- Challenges in Biogen's lupus programs, including reduced trial size and potential misalignment with regulatory expectations on study endpoints, may impact approval prospects.
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LEQEMBI Subcutaneous Filing
Q: Will LEQEMBI's subcutaneous form be filed in Q1 2024?
A: Yes, Biogen and Eisai plan to file the subcutaneous formulation of LEQEMBI by the end of March 2024, following positive bioequivalence data and ongoing discussions with regulators. -
LEQEMBI Launch Bottlenecks
Q: What bottlenecks are affecting LEQEMBI's launch?
A: The main bottlenecks are coordinating patient scheduling for initial MRI scans and access to neurologists. Aligning infusion initiation with MRI appointments is causing delays, despite no MRI capacity constraints. -
Expanding LEQEMBI Resources
Q: Why is Biogen adding more LEQEMBI resources?
A: Biogen is increasing field resources alongside Eisai to expand LEQEMBI's reach. Initially, one company led the field effort for efficiency. With better insights and more activated sites, both companies are now scaling up to reach more patients. -
Competition with Donanemab
Q: How will LEQEMBI compete with donanemab?
A: Biogen believes LEQEMBI has a significantly better safety profile regarding ARIA and, with its upcoming subcutaneous form, will offer greater convenience. The company will adjust its commercial strategy based on final labels and continues to focus on these competitive advantages. -
LEQEMBI Subcutaneous in Naïve Patients
Q: Is there enough data for subcutaneous LEQEMBI in new patients?
A: Biogen and Eisai believe they have sufficient data, including from 72 treatment-naïve patients, to support regulatory submission. A larger cohort provides additional safety data, and discussions with regulators are ongoing. -
AHEAD 3-45 Study Timing
Q: When is the AHEAD 3-45 interim analysis?
A: The AHEAD 3-45 trial is enrolling well, targeting preclinical Alzheimer's disease at different amyloid levels. An interim analysis opportunity exists, but no specific timelines have been communicated yet. -
SKYCLARYS European Launch
Q: What is SKYCLARYS's launch plan in Europe?
A: SKYCLARYS has been approved in the EU and will launch first in Germany. Early access programs are active in France and being negotiated elsewhere. Uptake may be slower than in the U.S. due to reimbursement processes, but Europe has a higher incidence of Friedreich's ataxia per capita. -
SKYCLARYS Growth Trajectory
Q: How will SKYCLARYS growth progress in 2024?
A: After an initial surge due to pent-up demand, growth will moderate as Biogen shifts to identifying new patients. The company doesn't expect another 20% growth this year but anticipates steady monthly increases contributing to overall growth in 2024. -
CD40 Phase III in Lupus
Q: Has the CD40 lupus trial reduced in size?
A: Yes, the trial size decreased from 450 to 320 patients to balance study design with the desire to expedite potential treatment delivery. Biogen believes the study remains appropriately powered and expects results in mid-2024. -
Angelman Syndrome Program
Q: Will Biogen continue the Angelman program?
A: Biogen will decide midyear whether to opt into a pivotal program based on data from the ongoing Phase Ib trial. The program may offer competitive advantages due to its unique ASO backbone and quarterly dosing schedule. -
SPINRAZA Return to Growth
Q: How will Biogen grow SPINRAZA sales?
A: Biogen plans to target adult SMA patients, who are often underdiagnosed, as only about 30% of SMA patients are currently treated. Demonstrating SPINRAZA's efficacy after gene therapy and developing a high-dose formulation may also support growth. -
ZURZUVAE Launch Metrics
Q: What are early signs from the ZURZUVAE launch?
A: Early metrics are encouraging, with both high-prescribing psychiatrists and OB-GYNs prescribing ZURZUVAE. Payers are moving quickly to ensure patient access, and prescriptions are coming faster than anticipated, bolstering confidence in the launch.