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CMO Dr. Sarah Gheuens emphasized that mitapivat has a very different mechanism of action, working to reduce 2,3-DPG and increase ATP to address both hemolysis and sickling. She contrasted this with Oxbryta's mechanism and pointed to mitapivat's robust, placebo-controlled Phase II data as strong support for its distinct and promising profile.

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Chief Medical Officer Dr. Sarah Gheuens confirmed that Agios would update the investor community on any changes to the drug's safety profile, consistent with past practices. CEO Brian Goff reiterated strong conviction in the multibillion-dollar potential, citing the significant unmet need in thalassemia, where two-thirds of U.S. patients lack approved therapies, and the growing need in sickle cell disease. Goff noted that more specific guidance would follow regulatory approvals and key data readouts.

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David Berman, EVP of R&D, expressed confidence, noting the trial's eligibility criteria and the expectation that the control arm will reflect real-world retreatment with anti-PD-1, providing the necessary contribution of components. Travis Coy, CFO, quantified the total revenue reserves from 2024 at approximately $18 million, which was spread roughly evenly throughout that year.

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Ralph Torbay, Head of Commercial, responded that the 90-patient dose selection analysis involves an 8 to 12-week follow-up period. The review will assess both safety and initial response rates, looking for significant differences between the two active doses.

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Ralph Torbay, Head of Commercial, stated that future growth in the current indication will be driven by the U.S., but the larger opportunity lies in label expansions. CFO Brian Di Donato added that the extending duration of therapy, now over 11 months, represents a significant upside with an unknown ceiling.

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Ralph Torbay, Head of Commercial, stated that future growth in the current indication will be driven by the U.S. due to European reimbursement challenges, but highlighted the much larger opportunity from label expansions (TEBE-AM and ATOM trials). CFO Brian Di Donato added that the extending duration of therapy, now over 11 months, represents a key upside with an unclear ceiling.

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CEO David Hallal explained that receiving observations is common and that a "very constructive" late-cycle FDA meeting was held after the observations were noted. He confirmed both facilities continue to operate and manufacture products, and that the agency is still working toward the September 22 PDUFA date. He also noted Scholar Rock's launch supply is manufactured and ready.

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Alisha Alaimo, President & Head of North America, stated that while competition is expanding the overall market (which grew ~15% in Q2), Leqembi maintains a majority market share of nearly 70%. She noted the competitor's growth is primarily from existing Leqembi prescribers. Priya Singhal, EVP & Head of Development, added that an independent analysis suggested the competitor's label update may have limited impact.

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Alisha Alaimo, President & Head of North America, stated that while a competitor helped grow the market by 15% in Q2, Leqembi maintains nearly 70% market share and is driving new prescriber growth. She noted it's too early to assess the label update's impact. Priya Singhal, EVP & Head of Development, added that an independent analysis suggested the competitor's modified dosing benefits were confined to a small patient subset.

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Executive Dave Gancarz stated that while data on both primary endpoints (PFS and OS) will be available for HARMONi, the company has not disclosed specifics on OS maturity. Regarding the HARMONi-2 hazard ratio, Gancarz emphasized the encouraging nature of the early positive trend. Dr. Jack West added that clinicians are not deterred by the preliminary nature and view a hazard ratio below 0.8 against a strong comparator like pembrolizumab as highly positive and clinically meaningful, suggesting strong potential for ivonescimab.

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Executive Dave Gancarz stated that while data on both primary endpoints will be available, the maturity level hasn't been disclosed, and approval will depend on a 'total package' review. Regarding the hazard ratio, he noted the early data is encouraging but has variability. Dr. H. Jack West, VP, added that clinicians view a hazard ratio below 0.8 against a strong comparator like pembrolizumab as highly positive and potentially practice-changing, even if preliminary.

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Pablo Cagnoni, President, Head of R&D, responded that for povorcitinib, results in the vicinity of the strong Phase II data would be very important. For tafasitamab in first-line DLBCL, he explained that because it's a curative setting, even a modest improvement in progression-free survival could be highly meaningful and lead to wide adoption, referencing the market uptake of Polivy as a benchmark.

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Matteo Trotta, an executive at Incyte, expressed excitement about the opportunity in pediatric AD, noting the high unmet need among 2 million patients. He conveyed confidence that Opzelura will maintain competitive overall formulary coverage for 2025, which would include the pediatric indication upon its potential approval.

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