BIIB Q2 2025: Subcutaneous Leukembi Drives 70% Share Stability
- Subcutaneous Leukembi Innovation: The Q&A emphasized Biogen’s progression toward a subcutaneous formulation for Leukembi, which offers enhanced patient convenience and a potential safety advantage (fewer infusion reactions). Physicians indicated strong positive feedback and flexibility in treatment options, reinforcing Biogen’s ability to differentiate its product from competitors.
- Advancing Blood-Based Biomarkers: Discussion on the rapid adoption of blood-based biomarker tests for Alzheimer’s highlighted that testing is nearly tripling, guided by new practice guidelines. This evolution could accelerate accurate diagnosis, drive treatment uptake, and serve as a catalyst for revenue growth in Biogen’s anti-amyloid therapy segment.
- Diversified and Robust Pipeline: The Q&A showcased strong pipeline diversification, including promising lupus phase III data and significant market potential in areas like selzardomab for AMR. With multiple candidates addressing high unmet needs, this diversified approach is expected to bolster long-term revenue growth and reduce reliance on any single product.
- Extended trial timelines and uncertainty: The design of the AHEAD‐345 trial—with a planned readout in 2028 and no clear interim analysis—creates significant uncertainty regarding timely approval and clinical validation versus competitors' approaches.
- Competitive pressure in the Alzheimer's market: Questions on Leukembi's market share, especially amid a competitor's updated label and emerging oral therapies, raise concerns that competitive dynamics could erode Biogen’s leadership.
- Adoption challenges for new diagnostic tests: The evolving yet inconsistent use of blood-based biomarkers—with uncertainty around proper reimbursement and their routine use in place of PET or CSF tests—could delay diagnosis and limit the impact of related anti-amyloid therapies.
| Metric | Period | Previous Guidance | Current Guidance | Change |
|---|---|---|---|---|
Non-GAAP Diluted EPS | FY 2025 | $14.50 to $15.50 | $15.50 to $16.00 | raised |
Total Revenue for 2025 | FY 2025 | Decline by a mid‐single‐digit percentage | Approximately flat compared to full year 2024 | raised |
Fit for Growth Initiative | FY 2025 | $1 billion of gross savings and $800 million of net savings | $1 billion of gross savings and $800 million of net savings | no change |
Non-GAAP R&D and SG&A Expense | FY 2025 | no prior guidance | $4 billion | no prior guidance |
Contract Manufacturing Revenue | FY 2025 | no prior guidance | Roughly consistent with full year 2024 | no prior guidance |
Ex-U.S. MS Business | FY 2025 | no prior guidance | Increased competitive pressures expected, particularly for TECFIDERA in Europe | no prior guidance |
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
Subcutaneous Leukembi | Q1 2025 highlighted improved patient convenience with at‐home administration and expected approvals with safety and efficacy benefits ; Q4 2024 emphasized at‐home dosing, increased accessibility, and outlined regulatory timelines | Q2 2025 reiterated improved convenience and optionality; noted safety advantages and significant physician/patient enthusiasm with preparations for filing for initiation therapy | Consistently positive with a stable focus on innovation and convenience improvements. |
Blood‑Based Biomarkers | Q1 2025 discussed their potential to simplify Alzheimer’s diagnosis despite regulatory and reimbursement uncertainties ; Q4 2024 stressed the promise of these biomarkers while cautioning about acceptance and reimbursement hurdles | Q2 2025 emphasized rapid adoption with significant growth in testing and updated practice guidelines, underscoring improved market momentum | Evolving sentiment with early caution giving way to increased optimism driven by rapid adoption. |
Robust and Diversified Pipeline with Extended AHEAD Trial Timelines | Q1 2025 outlined an expanding late‑stage pipeline with key studies and extended timelines for the AHEAD trial ; Q4 2024 reinforced the focus on Alzheimer’s with the AHEAD 345 trial design and a 2028 readout | Q2 2025 provided further updates on multiple Phase 3 initiatives and detailed the AHEAD 3-45 trial design with the readout expected in 2028 | A consistent narrative emphasizing a strong, diversified pipeline and long‑term clinical milestones. |
Competitive Dynamics in Alzheimer’s and Neurological Therapies | Q1 2025 examined the LEQEMBI versus donanemab debate and discussed emerging oral therapies (e.g., VUMERITY), highlighting market expansion needs ; Q4 2024 provided competitive context for LEQEMBI based on its unique mechanism and infrastructure developments without specifically naming emerging oral therapies or donanemab | Q2 2025 delved into detailed competitive dynamics, comparing market share, provider adoption, and the impact of donanemab’s label update while noting the differentiator of subcutaneous LEQEMBI | The discussion expanded in Q1 and Q2 with detailed competitive comparisons and market share insights, while Q4 had a more general competitive overview. |
European Reimbursement and Rollout for LEQEMBI | Q1 2025 provided an in-depth look at the complex reimbursement negotiations in Europe and the market potential due to aging demographics ; Q4 2024 mentioned generally ex‑U.S. launch advantages without specific European challenges | Q2 2025 did not mention European reimbursement challenges directly, focusing instead on global strategies | Once a focused topic in Q1, it has now been de‐emphasized or resolved, with fewer direct mentions in subsequent periods. |
Strategic Manufacturing, Collaboration, and Financial Strength | Q1 2025 discussed robust U.S.-based manufacturing capacity (RTP and Solothurn), external partnerships (e.g. Stoke Therapeutics), and strong cash flow and savings initiatives ; Q4 2024 emphasized financial strength and strategic initiatives through Fit for Growth and selective pipeline investments | Q2 2025 underscored ongoing investments in manufacturing (North Carolina capacity), new collaborations (with Citi Therapeutics and Eisai), and highlighted a robust balance sheet that supports growth plans | A steady emphasis on financial resilience with some fluctuations in manufacturing and collaboration focus, now reinforced by targeted investments in Q2. |
Declining MS Revenue and Increased Competition for SPINRAZA | Q1 2025 noted an 11% global decline in MS revenue due to generic and biosimilar competition, with SPINRAZA’s strong U.S. performance partly offset by shipment timing benefits ; Q4 2024 detailed an 8‑9% decline driven by competition from interferons, TECFIDERA generics, and TYSABRI biosimilars, while also discussing SPINRAZA’s competitive enhancements | Q2 2025 described resilient U.S. MS business performance with continued competitive pressures outside the U.S. and consistent global SPINRAZA demand amid inventory adjustments | Consistent challenges related to increased competition in MS therapy across periods, with regional contrasts and cautious but stable demand for SPINRAZA. |
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Leukembi Competition
Q: Is Leukembi losing market share?
A: Management explained that despite recent competitive entries like Kasunla, Leukembi retains almost 70% market share and continues expanding through new prescriber growth and additional options such as subcutaneous dosing, reflecting confidence in its competitive position. -
AHEAD Trials
Q: Will there be an interim analysis in AHEAD-three 45?
A: Management stated that for AHEAD three, they are aiming for a biomarker endpoint with a readout planned for 2028, while keeping interim optionality open; they highlighted key differences in patient selection and endpoints compared to competitor designs. -
Lupus Pipeline
Q: When can we see data for lupus agents?
A: They indicated that data for litifilumab in SLE might be available as early as late next year, with second phase III data for daprolizumab expected around 2027–2028, underscoring a multi–mechanistic strategy in a challenging market. -
SMA Dynamics
Q: How will myostatin products affect SMA share?
A: Management believes that myostatin products will serve as an additive benefit rather than a direct competitive threat to existing SMA therapies, ensuring that current market dynamics remain largely intact. -
Biomarker Adoption
Q: Are blood-based biomarkers replacing PET and CSF?
A: The team noted that while blood tests have tripled usage recently and are gaining traction for initial triage, most physicians continue to confirm positives with PET or CSF until reimbursement standards evolve. -
Eisai Partnership
Q: How is the Eisai relationship progressing?
A: Management reassured that despite arbitration over commercial allocations in Europe, the long–term relationship with Eisai is very strong, with continual high–level engagement showing a commitment to collaboration. -
Subcu Leukembi Feedback
Q: What is the market reaction to subcutaneous Leukembi?
A: Feedback from physicians has been very positive, with many appreciating the added convenience; the new subcutaneous option is viewed as a differentiator that gives patients more flexibility, particularly benefiting those in rural settings. -
Business Development
Q: Are early stage assets a focus for growth?
A: Management emphasized that they are actively pursuing early–stage deals to complement a robust late–stage pipeline, aiming to fill any future gaps cost–effectively while strategically leveraging their internal capabilities. -
Subcutaneous Logistics
Q: How will subcu administration be implemented?
A: They explained that subcutaneous administration offers flexibility, allowing either self–administration or clinic–based dosing depending on patient circumstances, with encouraging human factors study results supporting ease of use. -
AMR Opportunity
Q: What is the market potential for selzarnib in AMR?
A: Management estimated the addressable AMR market at around $1.5 billion, noting that selzarnib, along with its latest investigation in late microvascular inflammation, positions them well in this significant opportunity.
Research analysts covering BIOGEN.