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CEO Kenneth Galbraith corrected the premise, stating it was not a delay as the prior guidance was for the second half of 2025, which includes Q4. He emphasized that the trial is event-driven, and the timing is dictated by reaching the prespecified number of progression-free survival events, which is monitored blindly to maintain data integrity.

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CEO Kenneth Galbraith expressed strong confidence in zanidatamab's clinical data, highlighting its ability to generate high, durable responses with a favorable tolerability profile. He stated that while they follow competitors, they feel very comfortable with Zani's position and look forward to their own upcoming data readouts to confirm its potential.

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President and CEO Robert Blum distinguished between trial conduct and mechanism, highlighting ACACIA's optimized dosing. Fady Malik, EVP of R&D, added that the key question is whether the competitor's trial failure was due to drug-specific issues or the mechanism itself, which will inform confidence in ACACIA's potential success.

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Robert I. Blum, President and CEO, declined to specify details about echo monitoring frequency to protect competitive advantage but stated that it is reasonable for investors to assume an ETASU (Elements To Assure Safe Use) REMS is the approach being taken.

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David Ricks, Chair and CEO, affirmed that rebalancing pricing between the U.S. and Europe is a rational long-term goal. He suggested that using new products as an 'on-ramp' is a reasonable approach, provided structural changes occur in both markets, such as higher reimbursement in Europe and a deflation of the U.S. gross-to-net bubble. He stated Lilly is engaging constructively with the administration.

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Patrik Jonsson, President of Cardiometabolic Health, noted a disciplined approach to pricing and an evolution toward a smaller delta between list and net prices. CFO Lucas Montarce added that current pricing trends are consistent with forecasts and that the company remains disciplined in its approach to provide optionality and open access for patients, implicitly addressing the volume-over-price dynamic.

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An executive clarified that 'stable' refers to a continuation of the recent single-digit price erosion trend. Executive Patrik Jonsson added that Mounjaro adherence is already strong and access is high, suggesting a mature dynamic.

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CFO Mardi Dier attributed the quarter's strength to high demand, not inventory stocking. She reiterated that gross-to-net will fall within the 20-30% range for the year and that the Part D impact was minimal due to the 2024 baseline. CEO Bill Sibold added that gross-to-net is inherently choppy and includes factors like their widely used $0 co-pay assistance program, which is crucial for patient adherence.

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CEO William Sibold expressed high confidence, citing Rezdiffra's liver-directed mechanism of action and the meaningful 6.7 kPa reduction in liver stiffness observed at two years. He stated this data gives the team confidence in the ongoing MAESTRO-NASH OUTCOMES trial's ability to show a benefit in preventing adverse liver events.

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CEO William Sibold expressed confidence in both trials. He highlighted that positive results from a cirrhosis patient subset in a prior open-label study support the potential for Rezdiffra to work in this advanced population. He also noted that the significant interest and enrollment in the cirrhosis trial underscore the community's desire for a treatment and will generate important learnings.

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Chief Medical Officer Özlem Türeci reported that discussions with the FDA are positive and being finalized. She highlighted that the company is supplementing Chinese data with dose optimization data from Western populations in its global Phase 3 trials and expects to finalize the go-forward dose for all three indications shortly.

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Chief Medical Officer Özlem Türeci explained that both approaches will be relevant. She stated that BNT327 with chemotherapy aims to replace current CPIs, but as the treatment bar rises, ADC combinations with their bispecific will also become important. CEO Ugur Sahin added that several of BioNTech's proprietary ADCs are candidates for such combinations in NSCLC.

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CSO Ryan Richardson stated that while BioNTech is currently developing BNT327 independently for its initial trials, the company recognizes the program's broad potential. He confirmed they have been approached by other firms and are evaluating collaborations, suggesting a partnership is likely within the next 12-18 months to accelerate and expand development, particularly for combination therapies.

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President & CEO Dr. Leonard Schleifer questioned whether deferred rebates could be a factor in the competitor's strategy and stated they are looking into it. He emphasized that EYLEA HD is the ultimate answer to competition, given its superior profile and the trust physicians have in the Regeneron brand.

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President & CEO Dr. Leonard Schleifer stated they are looking into competitor rebate practices but emphasized that EYLEA HD is the company's 'real answer' to competition. He believes physicians will prefer EYLEA HD over both original EYLEA and its biosimilars as they gain more experience with its profile.

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President and CEO Dr. Leonard Schleifer stated that the company cannot correlate its foundation contributions to EYLEA usage, as it is not permissible. Regarding the contingency plan, he reiterated the strategy is to 'stimulate a community of givers' and did not outline an alternative if the matching program fails to attract other donors.

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President and CSO, Dr. George Yancopoulos, detailed the two-antibody strategy. REGN-7508 is designed for maximum anticoagulant activity, while REGN-9933 is a gentler option with a potentially lower bleeding risk. He explained this dual approach provides physicians and patients with flexibility to balance efficacy and safety, addressing a significant unmet need.

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COO Karen Massey confirmed the strong quarter in MG was fueled by the PFS expanding the prescriber base, with 150 of 1,000 PFS prescribers being new to Vyvgart. She also noted parallel growth in the IV business. CMO Luc Truyen expressed high confidence in the seronegative trial, explaining the primary endpoint was changed to 'change from baseline in MG-ADL' to increase statistical power, a move negotiated with regulators.

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COO Karen Massey asserted that Argenx is just at the beginning of the gMG growth curve, citing consistent new patient starts with over 50% coming from orals. She emphasized Hytrulo's role in expanding into earlier lines. CEO Tim Van Hauwermeiren added that the ongoing trial in seronegative gMG could expand the label by another 15%.

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EVP & Chief Medical Officer Samit Hirawat stated that he could not comment on trial specifics like dropout rates as the study remains blinded, but noted the current formulation has better tolerability than earlier versions of the drug. CEO Chris Boerner closed by reiterating that the company remains very excited about COBENFI's potential in Alzheimer's disease psychosis.

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CMO Samit Hirawat expressed confidence in the adjunctive schizophrenia trial, citing maintained efficacy in long-term data from other studies. For Camzyos, CCO Adam Lenkowsky confirmed the European label was updated to once every 6 months for echo monitoring in the maintenance phase, a change intended to increase capacity at Centers of Excellence.

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CEO Christopher Boerner stated there is no change to the J&J partnership and that they remain fully supportive of the milvexian program. Chief Commercialization Officer Adam Lenkowsky addressed the subcu Opdivo question by confirming the goal is to convert 30-40% of the U.S. business before the 2028 LOE, which, based on its broad patent estate, will extend the franchise into the next decade.

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Gregory Friberg, EVP and Chief R&D Officer, explained that while specific powering details are not being shared, the hypothesis is supported by preclinical data showing doubled skeletal growth and human genetic data. He noted that with BMN-333, they have the right molecule to test for greater growth and that while less frequent dosing is possible, the company is prioritizing maximizing efficacy and health benefits for patients.

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Greg Friberg, Executive Vice President and Chief R&D Officer, stated that the observed signals are known class effects for ASOs at high doses. He explained that BioMarin's choice of chemistry was intended to widen the therapeutic window by enhancing potency. He assured that patients are being monitored closely and that the upcoming data presentation will include the totality of available safety data from the cohort.

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CEO Alexander Hardy responded that while their BD focus is on genetically defined conditions, they are confident in their current CNP-based leadership strategy. He highlighted CNP's ability to treat other skeletal conditions and its critical safety profile for treating infants, which he described as a very high hurdle for any competing FGFR inhibitor to overcome.

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EVP, Chief Commercial Officer Cristin Hubbard highlighted the 65% year-over-year growth in patients and reiterated the company's confidence in its projected 25% CAGR for Voxzogo through 2027, driven by its broad label and global reach. President and CEO Alexander Hardy declined to elaborate on the specific legal strategy regarding IP, stating the company will provide updates when action is taken.

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Chairman & CEO Robert Davis noted consistent patient adds of 400-500 per month. EVP & CFO Caroline Litchfield added that while 75% of use is in sicker patients, over half of prescribers have used it in less severe cases. Dr. Dean Li, President of Merck Research Labs, confirmed the Hanzo GLP-1 is on schedule to enter the clinic this year.

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Chairman & CEO Robert Davis noted Winrevir has been consistently adding 400-500 patients per month. EVP & CFO Caroline Litchfield added that use in less severe patients is increasing. Dr. Dean Li, President of Merck Research Laboratories, confirmed that the Hanzo GLP-1 asset is on schedule to move into the clinic this year.

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CEO Robert Davis stated he would not speculate on the specifics of potential tariffs. He reiterated that Merck is well-positioned to manage impacts through short-term inventory and long-term manufacturing repositioning, but could not provide a specific financial impact without knowing the final tariff language.

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CEO Robert Davis explained the $25B+ figure is comprised of ADCs, small molecules, and the individualized neoantigen therapy, with the recent increase driven by the Harpoon acquisition and greater confidence in their TROP2 program. Dr. Dean Li, President of Merck Research Labs, added that their TROP2 ADC (SAC-TMT) is a differentiated molecule and emphasized the strategy of matching the right ADC to the right patient population.

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EVP & CMO Amy Peterson responded that the decision was based on a continuous assessment of a dynamic competitive and regulatory landscape. She emphasized the company is reallocating resources to other high-priority development opportunities for zanzalutinib as part of its 'Wave two' franchise strategy.

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Chief Medical Officer Amy Peterson declined to specify event rate targets for STELLAR-305, stating they await data maturation for the IDMC review. President and CEO Michael Morrissey addressed the BD question, indicating that while they evaluate all opportunities, they do not currently see clear differentiation in the crowded PD-1/VEGF bispecific space and are awaiting key clinical data from the class.

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Chief Medical Officer Amy Peterson stated that Exelixis is always looking to expand zanzalintinib into new indications. She clarified that in head and neck cancer, their trial is focused on the frontline setting, where they have a lead, rather than competing directly with bispecifics in the refractory space.

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Head of R&D Rob Iannone explained that data from three prior Phase III trials show consistent control arm performance with a median PFS between 6.9 and 8.1 months, which was factored into their trial design. He expressed confidence in zanidatamab, citing promising Phase II data and an upcoming overall survival data update at ASCO.

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EVP, Global Head of R&D, Rob Iannone, highlighted zanidatamab's differentiated mechanism as key to its potential. The ongoing Phase III trial targets the significant unmet need of patients who have progressed on T-DXd. The study randomizes patients to receive a physician's choice of chemotherapy plus either zanidatamab or trastuzumab, with the goal of being the first therapy to demonstrate efficacy in this setting.

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EVP, Global Head of R&D Robert Iannone highlighted zanidatamab's differentiated mechanism. He explained the ongoing Phase III trial is designed to address the data gap for patients who have progressed on T-DXd. The study randomizes patients to a physician's choice of chemotherapy backbone plus either zanidatamab or trastuzumab, aiming to be the first to show efficacy in this setting.

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Chief Commercial Officer Eric Benevich acknowledged the 70% reimbursement rate exceeded expectations but cautioned that this was achieved primarily through medical exceptions, as most health plans have not yet conducted formal formulary reviews. Chief Financial Officer Matthew Abernethy credited the market access team for effectively educating payers on the drug's value.

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CEO Kyle Gano addressed the market share question, stating that Neurocrine expects to remain the market leader due to INGREZZA's differentiated profile. On the second question, Chief Commercial Officer Eric Benevich noted that while some endocrinologists may use telehealth, their research indicates the majority will prefer an in-person visit to initiate treatment with a novel medication like CRENESSITY.

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CEO Kyle Gano explained that the molecule, NBI-570, has high selectivity for M1 and M4 receptors and is designed to be more CNS-penetrant, which avoids the need for a peripheral blocker. He noted that data from the Phase I muscarinic programs in 2025 will inform next steps and potential patient populations.

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CMO Noah Berkowitz explained that while regulators review overall survival (OS) for adverse trends, trials are typically submitted based on progression-free survival (PFS) and are not powered for OS. CEO John Houston added that while Arvinas can advance its neuro pipeline, it remains open to a strategic partner for later-stage development and will review options as data matures.

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Chief Medical Officer Noah Berkowitz clarified that the decision to advance the first-line combination is primarily driven by safety, with efficacy already established in later-line settings. CEO John Houston declined to comment on any questions related to the VERITAC-2 trial, citing the proximity of the data readout.

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CEO Richard Pops noted the programs are at different development stages and highlighted that ALKS 2680's true once-daily profile, which promotes daytime wakefulness while allowing for normal nighttime sleep, is a key differentiator. He deferred further comparison until Phase II data is available.

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CEO Albert Bourla explicitly declined to confirm any specific financial impact from a hypothetical tariff scenario, stating he was cautious about making such statements. He emphasized that the company's primary focus is on preventing tariffs, while having detailed contingency plans in place if they are enacted.

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CEO Albert Bourla and Executive Chris Boshoff declined to comment on the specifics of the formulation technology or the trial design, stating they had nothing to add at this time.

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Chief Scientific Officer Mikael Dolsten expressed confidence in the 25-valent vaccine, highlighting its superior immunogenicity for serotype 3, a key driver of disease. For danuglipron, he hypothesized that the modified-release formulation could offer a smoother pharmacokinetic profile with fewer peaks, potentially improving the patient experience and tolerability.

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CEO Dr. Cedric Francois and CMO Dr. Caroline Baumal refuted the 'warehousing' idea, emphasizing SYFOVRE's market leadership, growing injections, and differentiated long-term data. EVP of Commercial David Acheson added that Q4 channel inventory was within the typical 2-3 week range and not a cause for concern.

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CEO Brett Monia and Chief Clinical Development Officer Eugene Schneider responded. Monia clarified the study is well-powered for its primary endpoint of triglyceride reduction. While not explicitly powered for acute pancreatitis (AP) reduction due to a lack of precedent, the large trial size and positive AP data from the FCS study provide confidence in seeing a meaningful signal. Schneider added that there is no established threshold for a clinically meaningful AP reduction, so any significant decrease would be viewed positively.

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CEO Brett Monia clarified that EEG is being measured as an exploratory biomarker in the Phase III and long-term extension studies to better understand the disease's biology, not as a clinical endpoint. He acknowledged that EEG patterns differ by age, with adults having a more muted signal, and stated that the long-term extension EEG data has not yet been formally assessed.

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