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Alisha Alaimo, President & Head of North America, responded that Biogen views myostatin inhibitors as providing an additive benefit for SMA patients. She clarified that the company does not see them as a direct competitor to Spinraza or other existing SMN-modifying therapies and does not anticipate a significant issue for their franchise.

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Alisha Alaimo, President & Head of North America, responded that Biogen views myostatin inhibitors as a potential additive benefit for SMA patients. She clarified that the company does not see them as a direct competitor to Spinraza or other existing SMA therapies and does not anticipate them being a significant issue for the franchise.

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Head of Development Dr. Priya Singhal explained that the AHEAD 3-45 study is uniquely designed to assess LEQEMBI across the full spectrum of presymptomatic Alzheimer's, unlike competitor studies with mixed populations. CEO Christopher Viehbacher added that this design will provide crucial data on the risk-benefit of treating patients at different amyloid levels, which he believes will make it a landmark study for physicians.

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Dr. Priya Singhal, Head of Development, explained that an FDA-approved, widely reimbursed in-vitro diagnostic is a critical near-term catalyst to build physician confidence and streamline the care pathway. She noted that while triage tests exist, full approval and data demonstrating concordance with PET scans will be key for broad adoption.

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Dr. Priya Singhal, Head of Development, confirmed that enrollment for the study was completed in October. While the trial has a 216-week primary endpoint, she mentioned that Biogen is actively engaging with regulators to explore all options for when the study might read out and will provide future updates.

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CEO David Hallal positioned the study as an initial exploration of Scholar Rock's potential role in obesity. President of R&D Akshay Vaishnaw clarified that the readout's primary focus will be the 24-week data on lean mass changes and safety. He emphasized the importance of addressing muscle loss but did not commit to a specific quantitative benchmark for success.

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Executive Jay Backstrom clarified that at the 24-week timepoint, they expect total weight loss to be comparable between the combination arm and the placebo arm. He explained that the magnitude of weight loss from tirzepatide is so significant that any effect from muscle preservation on total weight would likely be a 'wash' at this early stage. However, he acknowledged the potential for incremental weight loss over a longer treatment period.

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Executive Jay Backstrom explained that the EMBRAZE trial is a proof-of-concept study using apitegromab to validate their selective anti-myostatin approach, with the primary endpoint being lean muscle mass at 24 weeks. This is intended to guide the development of SRK-439, which will be a subcutaneous formulation. He noted that for the EMBRAZE data, success would be defined by the preservation of lean muscle mass, which is considered clinically meaningful for improving the durability of weight loss, reducing fat mass, and enhancing glucose metabolism.

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President and CEO Dr. David Chang explained that a 3-4 month lag between site activation and patient screening, caused by site-level staffing shortages, led to the revised timeline. Dr. Zachary Roberts, EVP of R&D and CMO, added that the 250 consented patients represent the top of the screening funnel, with improving site engagement now translating this interest into trial enrollment.

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EVP of R&D and CMO Dr. Zachary Roberts stated the company is agnostic regarding the need for ALLO-647, as both outcomes present strategic benefits. For the H1 2026 interim analysis, he confirmed it is a formal efficacy test on the primary endpoint of event-free survival with some alpha spend, making a statistically significant finding possible, which could accelerate regulatory discussions.

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Joshua Smiley, President and COO, attributed the VYVGART sales dip to Chinese New Year seasonality affecting IV infusions and a Q4 inventory build for Hytrulo, but noted a strong rebound in April. Dr. Samantha Du, Founder and CEO, affirmed that Zai Lab maintains a high bar for business development but will actively pursue differentiated, high-potential assets for both regional and global rights.

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Joshua Smiley, President and COO, explained that VYVGART's growth will accelerate in the second half of 2025 due to the compounding effect of returning patients and an expected update to treatment guidelines. Dr. Rafael Amado, President and Head of Global R&D, added that for ZL-1310, they are in discussions with regulators for an accelerated approval pathway, plan to start a pivotal study in 2025, and are confident they are about 1.5 years ahead of competitors.

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President and COO Josh Smiley confirmed the company is on a trend to meet or exceed the $70 million VYVGART guidance but noted it's early to precisely model patient cycles. Executive Officer Jonathan Wang addressed business development, stating priorities are late-stage, de-risked regional deals and earlier-stage assets with global potential.

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Karen Akinsanya, President of R&D and Therapeutics, stated that the initial SGR-1505 data update will cover safety, pharmacokinetics (PK), and pharmacodynamics (PD), along with preliminary efficacy. Geoffrey Porges, CFO, addressed cash burn, noting he does not anticipate a substantial increase next year as the company maintains optionality with its lead programs.

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CEO Reshma Kewalramani explained that the VX-993 study will explore its full dose range to assess if it can improve upon JOURNAVX's efficacy and serve as an option for future combinations. CCO Duncan McKechnie clarified that third-party retail data doesn't capture hospital usage, and the total prescription number was 25,000. He noted that week-to-week variability is common early in a launch and that growth will increase with payer coverage.

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COO Stuart Arbuckle expressed high confidence in securing broad coverage over time across all payer segments. He cited the significant unmet need for effective non-opioids and supportive federal and state policy initiatives as key factors that should facilitate smooth market access for JOURNAVX.

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CEO Dr. Reshma Kewalramani explained that VX-993 supports serial innovation, enables an IV formulation, and provides optionality for a future NaV1.7 combination. On inaxaplin, she noted the current regulatory agreement is for an accelerated approval based on GFR slope, but acknowledged the positive evolution of regulatory discussions around proteinuria.

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Robert Bradway, CEO, expressed high confidence in MariTide's Phase III design, stating it was informed by Phase I and II data showing dose escalation improves tolerability without sacrificing efficacy. Murdo Gordon, EVP of Global Commercial Operations, added that while an oral market is expected, MariTide's monthly or less frequent dosing makes it less vulnerable to competition than weekly injectables.

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CEO Robert Bradway and EVP of R&D James Bradner refuted the idea of 'slip-ups,' clarifying that early-stage programs are held to a high bar. Dr. Bradner affirmed confidence in a deep pipeline behind MariTide, including oral and subcutaneous candidates with diverse mechanisms, and noted an openness to external partnerships.

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EVP of R&D James Bradner responded that while MariTide is the primary focus, Amgen is actively developing a broader portfolio. He confirmed the company is pursuing both injectable and oral medicines, as well as incretin and non-incretin mechanisms, to address the diverse needs of the obesity market.

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Chief Commercial Officer Johanna Mercier stated the team is ready for the launch following the anticipated June 19 PDUFA date. She projected that access would ramp to 75% of covered lives within six months and peak at 90% within a year, with initial access facilitated through medical exceptions. This gradual build-out is expected to support a strong launch trajectory through 2025 and into 2026.

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CEO Daniel O'Day stated that interactions with the FDA are on track for a summer approval, supported by its Breakthrough Therapy designation. CCO Johanna Mercier added that the European strategy involves a tiered, country-specific approach and highlighted the EU filing's importance for the EU-M4all initiative, which facilitates access in over 130 low- and middle-income countries.

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Johanna Mercier, Chief Commercial Officer, expressed high excitement for the launch, outlining clear growth opportunities in expanding the market size to new consumers (Black, Latino, women) and prescribers. She anticipates lenacapavir will impact both Descovy and the generic oral market. Mercier confirmed that commercialization plans are well underway to ensure a seamless experience for providers and consumers, with more details to be shared at the December HIV analyst event.

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President Stephen Hoge described a 2026 readout for the INT vaccine as 'possible, plausible' but emphasized it is event-driven and timing remains uncertain. For Norovirus, he explained that since the Northern Hemisphere cohort is fully enrolled and constitutes the majority of the study, it's possible that participants from the Southern Hemisphere may not be needed to hit the efficacy endpoint.

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President Stephen Hoge stated that discussions with the FDA are ongoing for the combo vaccine's BLA submission. CEO Stéphane Bancel addressed the RSV market, noting that lower-than-expected demand, new CDC guidelines, and significant channel inventory from competitors have impacted sales, but expressed confidence for 2025 with a full contracting season and ex-U.S. approvals.

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David Berman, Head of R&D, clarified that for the HIV trial, the focus of the Phase 1 dose escalation is not on a specific rate but on observing activity, noting a commercially successful target product profile (TPP) would involve suppressing viral copies to less than 200 copies/ml for two years in 20-30% of patients. Ralph Torbay, Head of Commercial, addressed European sales, attributing the performance to a challenging reimbursement environment and ongoing price negotiations in key markets like Germany and France.

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Ralph Torbay, Head of Commercial, explained the $6.7 million reserve was a 'onetime thing' based on negotiations with France and Germany but cautioned against simply adding it back in future quarters. David Berman, Head of R&D, stated that for the HIV program, seeing any biological activity is significant for a first-in-class therapy in a low-target-density setting. He confirmed they are enrolling more patients and exploring higher doses, with a full data release planned for Q1 2025.

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Ralph Torbay, Head of Commercial, explained the $6.7 million reserve was a one-time adjustment based on negotiations in France and Germany, cautioning it affects future periods as well. David Berman, Head of R&D, stated the HIV program shows biological activity at low target densities, and they are enrolling more patients and exploring higher doses before the Q1 2025 data release.

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President and CEO Gene G. Kinney clarified that the control arm is expected to behave similarly to the VITAL trial's control arm (median survival ~8.3 months), as daratumumab has not shown an impact on early mortality. Chief Development Officer Chad Swanson added that blinded event timing in AFFIRM-AL appears consistent with VITAL, reinforcing this expectation.

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Interim CEO Frederick Vogt responded that reimbursement time has been reduced to an average of 3 weeks, which aligns well with ATC scheduling needs and is not seen as a bottleneck. For the lung cancer trial (IOV-LUN-202), he reiterated that data is expected in 2025, with a potential U.S. approval in 2027.

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CEO John Evans confirmed the completion of dosing for the first cohort and reiterated guidance for a data release in 2025. He indicated that they would wait to present data until a clear profile of the drug emerges, which would likely require results from multiple dose cohorts. Key biomarkers of interest are increased normal alpha-1 protein and decreased toxic Z protein.

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CEO John Evans confirmed the 2025 guidance for an initial data release. He stated the company would share data once a 'clear profile of the drug' emerges, which he suggested would mean results from at least multiple dose cohorts. Key data points will include levels of normal M alpha-1 protein, reduction of toxic Z protein, and safety.

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President and CEO Stephen Mahoney described the FDA meeting for VRDN-003 as "positive" and reiterated guidance for a pivotal program start in mid-2024, pending official minutes. Chief Medical Officer Thomas Ciulla explained that the study uses standard MedDRA terms for reporting, audiometry for monitoring, and has a specific exclusion criterion for baseline hearing loss.

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