Leonid Timashev • RBC Capital Markets

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Alan Bash, President of CARVYKTI, stated that the company will drive both supply and demand simultaneously and expects the ex-U.S. contribution to become increasingly meaningful as more markets launch in 2026. He detailed U.S. demand drivers including growing awareness from ASCO data, the positive impact of REMS removal, and new direct-to-patient marketing efforts.

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Alan Bash, President of CARVYKTI, stated that while general CAR-T awareness is growing, their efforts are focused on driving action specifically for CARVYKTI based on its earlier-line approval. He affirmed that both Legend and J&J are committed to positioning CAR-T as the best option for eligible patients, citing IMWG recommendations, and noted that dedicated sales teams from both companies are delivering this message.

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Executive Alan Bash clarified that the 10,000-dose target is an annualized run rate exiting 2025, positioning the company to supply the market in 2026. He highlighted significant upside from expanding treatment sites and community penetration. Executive Ying Huang added that Legend and J&J have jointly decided to invest in further expanding the Tech Lane facility in Belgium, with additional capacity expected online in 2028, signaling confidence in long-term demand.

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SVP Steven Gavel noted that European adoption is slower due to pricing negotiations and a different care model, with Germany being the key market. CEO Ying Huang stressed that overall survival data is paramount for Europe's single-payer systems, making CARVYKTI's OS benefit a powerful tool in reimbursement discussions. CMO Mythili Koneru added that strong trial enrollment in Europe shows high physician interest.

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President and CEO Robert Blum stated that specific messaging would not be revealed pre-approval. Andrew Callos, EVP & Chief Commercial Officer, added that physicians focus on efficacy balanced with safety and the REMS. He expressed confidence in aficamtan's differentiation across these areas, with details to be unveiled at launch.

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Andrew Callos, EVP and CCO, projected that aficamten's uptake in nHCM would be faster than in oHCM. This is due to ongoing market development, growing physician familiarity with cardiac myosin inhibitors, and the potential for positive MAPLE and ACACIA data to expand use beyond centers of excellence.

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EVP of R&D Fady Malik explained that while KCCQ is the primary endpoint, regulators want to see consistency across both symptomatic (KCCQ) and functional (exercise) endpoints. He noted that ACACIA includes an exercise endpoint as a secondary measure and that, practically, there isn't a significant difference between their approach and a dual primary endpoint design, as both aim to show strength of evidence across domains.

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CEO William Lewis described physician enthusiasm as 'universal or uniform' across geographies, citing strong relationships built through international congresses and the ARIKAYCE launch. He noted positive regulatory interactions in Europe and the UK. He also reminded analysts that Insmed's strategy for ARIKAYCE was to set the same list price across the US, Europe, and Japan, suggesting a consistent global approach.

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Chief Commercial Officer Ari Maizel clarified that the coverage expansion was the result of pull-through from previously announced GPO contracts. Chief Financial Officer Nick Pizzie added that despite the improved access for 28 million new lives, the company is able to maintain the mid-50s gross-to-net percentage range for Auvelity.

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Mark Jacobson, Chief Operating Officer, stated that engagement with the FDA remains "status quo" with no changes to the feedback received for the planned sNDA submission for AXS-05 in AD agitation. He confirmed that the drug has Breakthrough Therapy designation, making it eligible for priority review, a determination the agency makes at the time of filing.

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General Counsel Hunter Murdock explained the settlement dates were a negotiated resolution and not tied to a specific event. Chief Financial Officer Nick Pizzie added that with the loss of exclusivity (LOE) date now clearer, the company plans to update and refine its guidance as the launch progresses.

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CEO Herriot Tabuteau explained that the patient populations in ADVANCE-2 and ACCORD-2 are very similar to their respective predecessor trials, as they are designed to be replicative studies. He confirmed that event rates in ACCORD-2 are in line with expectations, reinforcing confidence in the Q4 data readout timeline.

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CMO Dr. Guy Goodwin explained that while detailed time-course data is not yet available, there is no imbalance in suicidality between the drug and placebo arms in the TRD trials, suggesting it's illness-related. In the anorexia study, he noted higher overall rates of suicidality, reflecting the high-risk population, but again saw no imbalance between arms, which he described as reassuring for the overall program.

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Chief Medical Officer Dr. Guy Goodwin outlined two ways durability is measured: the maintenance of the change in MADRS score from baseline and the time until a new treatment intervention is required. He noted that from a clinical perspective, it would be unsurprising for patients who respond well to start maintenance antidepressants, and this could be a valid form of achieving durability.

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Kabir Nath (Executive) and Lori Englebert (Executive) distinguished between the trial and commercial settings. Lori Englebert explained that trial protocols are inherently more rigid. For commercialization, she outlined a strategy focused on physician education for referrals and optimizing patient flow at treatment centers, drawing parallels to the successful adaptation of centers for Spravato. She expressed confidence that learnings from collaborations will help streamline the process for COMP360.

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Craig Hopkinson, EVP and Chief Medical Officer, affirmed that both MWT and ESS are important, noting the strategic decision to use a dual primary in the NT2 study. Richard Pops, Chairman & CEO, highlighted the clear and robust signals on cognition and fatigue. Marcus Yountz, VP of Clinical Development, confirmed the team is actively working to elevate these endpoints for the Phase 3 program.

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COO Blair Jackson and CEO Richard Pops explained that while patient-reported outcomes in the Phase II studies touch on these domains, the primary readouts are focused on core sleep endpoints. CEO Pops confirmed that standard human abuse potential studies are being conducted as a routine part of the neuroscience program's development.

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Chief Commercial Officer Eric Benevich acknowledged that their competitor gained some share in 2024 with its XR launch but affirmed INGREZZA remains the leader in a growing class with significant headroom. He confirmed the complex payer environment will persist. CEO Kyle Gano added that Neurocrine's 'small biotech exemption' delays its IRA price negotiation event to 2029, providing time to learn and prepare.

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