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Interim CEO Ian Smith clarified that the 20-patient European cohort was added to satisfy specific regulatory requirements for a needle-prick sham and to maintain the integrity of the main 150-patient study. CMO Barry Ticho confirmed 1:1 randomization applies to this cohort. For ADOA, he noted that based on long oligonucleotide half-lives in animal models (9+ months), a single injection is expected to have an effect for the full 12-month trial.

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CEO Matt Gline responded that while the consistent positive results from prior open-label studies are 'comforting,' they are not a substitute for placebo-controlled data, especially given the known variability of the TIS endpoint. He expressed cautious optimism, noting that he will 'bite my nails and lose sleep' until the Phase 3 data is available. He also added that the dual JAK1/TYK2 inhibition of brepocitinib could provide an additional therapeutic edge.

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CEO & Director Matt Gline acknowledged the placebo response is a reasonable question, pointing to recently published data from a competitor's myositis study as encouraging, showing a well-behaved placebo arm. Regarding the buyback, Gline and CFO Richard Pulik confirmed they are continuing to execute the existing authorization and will evaluate their capital position before deciding on future programs.

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CEO Matthew Gline clarified that the cutaneous sarcoidosis study is a proof-of-concept trial focused on signal-finding and understanding dose response, rather than being powered for a specific statistical outcome. Regarding Graves' disease, Gline stated that while there's no specific numeric bar, any meaningful amount of remission would be encouraging and would set them up well for the Phase III study, noting even a couple of patients in remission would be a happy outcome.

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Interim CFO Jessie Yeung clarified that global enrollment for CARTITUDE-VI is complete, except for a small cohort in Japan. President of CARVYKTI Alan Bash expressed confidence in second-half capacity expansion, citing the Novartis ramp-up, the Ghent (Techlane) facility coming online, and other network efficiencies, ensuring continued growth.

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Alan Bash, President of CARVYKTI, confirmed that the Obelisc facility is now supplying Europe and expects modest growth in Q2 with acceleration in the second half of the year, supported by both European and U.S. capacity. He also affirmed that, as per the CD30 process described by CEO Ying Huang, no inspection is expected for the Raritan physical plant expansion.

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Executive Jessie Yeung explained the higher diluted share count was due to reporting a net profit under IFRS, which requires a different calculation, and it would revert if a net loss is reported. Executive Guowei Fang detailed the early pipeline, expecting dose escalation readouts for solid tumor programs (gastric, small cell lung cancer) and multiple readouts from allogeneic programs in China. He also mentioned an autoimmune program targeting CD19/20/22 is expected to have an initial clinical readout.

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CEO Ying Huang reaffirmed expectations for sequential growth in Q4 but did not provide quantitative guidance. He clarified that the FDA regulates capacity for all CAR-T manufacturing facilities, not just for the BCMA class, and highlighted that CARVYKTI has supplied the highest revenue and number of slots in the market 10 quarters post-launch.

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CEO Kenneth Galbraith indicated that initial ZW191 data could be presented at a peer-reviewed medical conference in 2025 or 2026, contingent on abstract acceptance. Chief Scientific Officer Paul Moore confirmed folate receptor alpha expression in a subset of NSCLC patients and noted ZW191's design, including its bystander effect, is well-suited for this indication.

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President & CEO Jan Møller Mikkelsen confirmed the analyst's assumption of €4-5 million in sequential ex-U.S. revenue growth was accurate, implying the remainder of the growth was from the U.S. He stated it was too early in the launch to provide a normalized growth forecast but noted that new patient enrollment numbers were similar in Q2 compared to Q1.

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Jan Mikkelsen, President and CEO, explained that the timing is controlled by Takeda but expects the major transition to occur in the next year. He noted different uptake patterns in Germany versus Austria, with some physicians switching existing NATPARA patients and others prioritizing new patients, suggesting a dynamic situation for the U.S. launch.

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President and CEO Jan Mikkelsen and CFO Scott Smith clarified the numbers. Mikkelsen confirmed that the 'real' Q2 net sales were approximately €53.4 million after adding back the true-ups, representing a strong sequential increase. He noted the full-year guidance was conservative and did not include potential seasonal upside. Smith added that the reported H1 revenue of €91.2 million was already net of a €7.6 million true-up, meaning the underlying H1 performance was closer to €100 million.

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Chief Medical Officer Tahamtan Ahmadi detailed several differentiators: having a positive Phase III result in second-line follicular lymphoma where the competitor does not, consistently better efficacy signals, the advantage of subcutaneous administration, and a comparable safety profile.

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CMO Tahamtan Ahmadi noted that while historical second-line endometrial cancer therapies have response rates of 10-15%, he is confident Rina-S data will show a best-in-class profile. CDO Judith Klimovsky stated the acasunlimab update is planned for H2 2025 to allow for meaningful follow-up on the overall survival endpoint, which must beat the comparator's 11-month median.

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Chief Operating Officer Anthony Mancini reported that DARZALEX's growth is driven by frontline use, where new patient share reached 53%. He noted that growth in frontline and second-line settings came at the expense of later lines. Chief Medical Officer Tahamtan Ahmadi described the fixed-duration debate as 'academic,' confirming that EPKINLY will be given for a fixed duration in combination studies due to higher efficacy. He emphasized that subcutaneous delivery is a more fundamental advantage, enabling treatment in more diverse healthcare settings.

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CEO David Hung reiterated that zero of the 70 new patients came from clinical trials and explained that the 50 US patients in the TRUST program will remain on the trial to collect long-term durability data. CFO Philippe Sauvage stated the $25 million milestone from their Japanese partner is expected to be recognized as revenue later in the year.

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Emil Kakkis, CEO, expressed confidence that the CRL issues are 'very doable' and not expected to be delayed. Howard Horn, CFO, reiterated the 2027 GAAP profitability goal and explained that spending associated with delayed programs is being prudently deferred. This includes pausing hiring for commercial launches and managing overall headcount.

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CEO and President Emil Kakkis clarified that he referred to 'variation' in baseline fracture rates, not 'dispersion,' which is managed by stratification and statistical methods. He explained that while the 67% fracture reduction rate was consistent between the 6-month and 14-month Phase II data cuts, the p-value improved dramatically to 0.0014 at 14 months because the longer duration allowed the treatment and placebo groups' cumulative fracture counts to separate further, increasing statistical power.

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CMO Eric Crombez and CEO Emil Kakkis clarified that the study stratifies patients by baseline fracture rate and age, not directly by OI type. While they will conduct sensitivity analyses on fracture rates by subtype, it is not a formal secondary endpoint.

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CEO Emil Kakkis stated that if an interim analysis is successful, the company will only announce that the threshold was met, without releasing specific data like the hazard ratio until the full database is locked. On DTX401, he confirmed the tech transfer to their own plant is complete, with PPQ lots running, and expects this to reduce costs by around 40% compared to a contract manufacturer, which will improve margins.

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James Bradner, EVP of R&D, responded that data from the Phase 2 study's second part is expected in 2025 and that more details about the data readout would be shared in due course, without confirming the specific granularity requested.

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James Bradner, EVP of R&D, clarified that the ADA presentation will focus on the first 52 weeks of data and mechanistic studies, with the 76-week data expected at year-end. Regarding a switch study, he confirmed that management agrees it is an important clinical question and intends to generate that data in the future.

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James Bradner, EVP of R&D, stated that the mechanism for the investigational obesity medicine AMG 513 remains undisclosed due to competitive reasons. Murdo Gordon, EVP of Global Commercial Operations, expressed confidence in the continued growth of the biosimilar portfolio, including AMGEVITA, which grew 16% in the previous year.

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EVP of Global Commercial Operations Murdo Gordon confirmed Enbrel's quarter was soft due to net price declines and an unfavorable sales deduction adjustment, though volume grew 4%. For Prolia, he acknowledged the broad provider base demonstrates its utility and that this market presence could be an advantage against future biosimilar competition.

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CEO Ugur Sahin responded that the mechanism of BNT327 is more complex than simple cooperative binding and that more detailed data will be presented mid-next year. He described the mechanism as binding to PD-L1 within the tumor microenvironment, which in turn creates an opportunity to bind to VEGF-A, resulting in synergistic activity.

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CEO Ugur Sahin noted encouraging data for BNT327 in the EGFR mutant population and that they are considering ADC combinations. For BNT323, CMO Özlem Türeci explained the potential BLA submission would be based on a single-arm trial in a broad HER2-positive population, with objective response rate (ORR) as the primary endpoint. She confirmed they are in ongoing discussions with regulators.

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CSO Ryan Richardson stated that BioNTech is closely monitoring the U.S. policy environment. He expressed the company's expectation that a strain selection will be made and affirmed that BioNTech is prepared to respond rapidly, consistent with its performance in previous years.

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CEO Dr. Ugur Sahin clarified the initial TNBC trial is intended for the patient population with CPS below 10, with the comparator being chemotherapy alone, but they are evaluating additional trials for the above 10% population. Chief Strategy Officer Ryan Richardson confirmed the comparator for the small cell lung cancer trial will be chemo plus Tecentriq.

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COO Karen Massey reiterated that the subcutaneous strategy is for market expansion, not a forced switch, noting that the IV business continues to grow. CMO Luc Truyen explained the ENERGIZE trial is designed to broaden EMPA's potential by studying it in IVIG-refractory or naive patients, complementing the head-to-head IVIG study and addressing the one-third of CIDP patients who may not be IgG-dependent.

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Chief Operating Officer Karen Massey stated that the company is not updating the specific patient number at this time but will do so at future milestones, consistent with past launch practices. She reiterated that the launch shows consistent patient and prescriber growth, with 85-90% of patients switching from IVIG or SCIG, which is in line with expectations and signals a long growth trajectory ahead, to be further driven by the PFS launch.

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Chief Financial Officer Karl Gubitz explained that payer agreements will be re-established for the PFS, and they expect VBAs will not be part of the new pharmacy benefit contracts. Chief Operating Officer Karen Massey added that physicians are generally not using formal scales like INCAT in clinical practice, instead relying on simpler assessments and patient conversations to determine response.

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CEO Tim Van Hauwermeiren said an R&D Day would feature full data for empasiprubart in MMN. He explained that systemic scleroderma was prioritized due to its strong IgG-driven biology, validation from passive transfer models, and a clearer clinical path. This contrasts with AAV, where the confounding effects of background medications posed an unmanageable risk.

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EVP & CMO Amy Peterson clarified that for STELLAR-304, hitting either of the dual primary endpoints of PFS or ORR would constitute a positive study. She declined to comment on the control arm performance in STELLAR-303, stating the data would be shared at a future medical conference.

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CFO Christopher Senner noted no significant quarter-over-quarter impact from the Part D redesign and stated the payer mix is roughly equal between commercial and Medicare Part D. EVP of Commercial P.J. Haley clarified the $1 billion NET market is across all lines, but oral small molecules, like CABOMETYX, represent the majority of use in the second and third-line settings, which is a substantial opportunity.

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President and CEO Michael Morrissey addressed the RCC question by stating that the company's overarching goal is to improve the standard of care for patients, which is the strategic driver for its work with zanzalintinib. He deferred specific comments on the trial designs with Merck until an appropriate future time.

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President and CEO Michael Morrissey clarified that the focus on late-stage opportunities is not new, as the company's early-stage pipeline is already full. He confirmed that Exelixis is open to virtually any type of transaction, including acquisitions, provided it is the right asset at the right valuation that can deliver clinically differentiated data.

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CFO Aaron Rosenberg detailed the Q1 impact of the Part D redesign, noting a net favorability due to the elimination of the coverage gap liability, balanced by their new liability under the small manufacturer designation. Matt Shaulis, GM of North America, added that typical Q1 seasonality, including inventory drawdown and fewer shipping days, also affected revenue. He stated that TEVIMBRA sales are not broken out by region but noted U.S. patient starts are in line with expectations. Rosenberg confirmed the Swiss API supplier approval and mentioned work to secure another supplier in Spain to enhance supply chain resiliency.

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CFO Aaron Rosenberg noted that while the Part D redesign has an impact, BeiGene benefits from a small manufacturer designation, resulting in some Q1 favorability. Matt Shaulis, GM of North America, added that Q1 seasonality and inventory changes were also factors and that the company does not break out TEVIMBRA sales by region. Rosenberg confirmed they are diversifying their API supply chain with suppliers in Switzerland and Spain and have significant stockpiles.

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Chief Global Product Strategy Officer Kyle Jenne stated that partner AstraZeneca believes the Part D redesign will be a net positive for WAINUA, potentially increasing patient starts and compliance due to lower out-of-pocket costs. Regarding TRYNGOLZA, he noted that while new patients are being identified, growth will take time and effort. CEO Brett Monia added that WAINUA's ex-U.S. launches will also contribute to revenue growth.

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Chief Clinical Development Officer Eugene Schneider explained the Angelman study's powering was based on natural history data and the very encouraging Phase II results for the expressive communication endpoint. CFO Beth Hougen clarified the R&D revenue guidance is not dependent on any single large milestone but rather on continued funding from AstraZeneca for a large study and a host of smaller, back-end loaded milestones from various partnerships.

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