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Chief Commercial Officer Dan Kirby explained that confidence is high because two of the three major U.S. wholesalers resumed regular ordering in Q2, which will better align Proleukin sales with Amtagvi demand. He confirmed the average number of Proleukin doses per patient remains consistent and that revenue from manufacturing and clinical trial channels is also expected to continue.

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Interim CEO Frederick Vogt and COO Igor Bilinsky confirmed there was no manufacturing success issue in Q4 and that rates have already rebounded in Q2. Vogt stated the guidance revision is driven by ATC launch dynamics and learning curves, not fundamental uncertainty in demand or manufacturing capability.

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Interim CEO and President Frederick Vogt confirmed that Proleukin revenue continues to be a leading indicator for Amtagvi sales. He attributed the Q4 performance to full uptake by all major U.S. distributors and projected that Proleukin could contribute $80 million to $100 million or more to the full-year 2025 revenue guidance.

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Interim CEO Frederick Vogt explained that Iovance is stocking three major distributors sequentially, with one expected in Q4. He noted that Proleukin sales could increase in Q4, but after that, starting in 2025, growth is expected to normalize and follow a more traditional quarter-over-quarter pattern.

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Chief Medical Officer Dr. Mollie Leoni reiterated that FDA interactions are proceeding as expected for a priority review with no change in frequency or quality. On the maintenance setting, Dr. Leoni and CCO Brian Powl explained that while not an initial indication, it is built into the COMET-seventeen frontline trial design and represents a significant opportunity for extended treatment duration.

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Executive Mollie Leoni described the approach as 'mutationally agnostic' and potentially transformative, as it should work in both imatinib-naive and refractory patients by targeting KIT through two different mechanisms. She expects to see deeper and longer-lasting responses (PFS) and noted that salvaging a failing response would be a clear sign of synergy.

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CEO Troy Wilson confirmed a development candidate for diabetes is targeted for mid-2025, with interest in both Type 1 and Type 2 diabetes. He described the program as a high-value 'call option' that would require a partnership for late-stage development. The ideal strategy would involve a structure that separates the IP and allows for monetization to benefit Kura shareholders in the nearer term.

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EVP of Clinical Development, Dr. Mollie Leoni, expressed encouragement about potential responses post-venetoclax failure, with more data coming at ASH. For duration of response, she noted it's too early to tell as most patients remain on therapy, but highlighted that while KMT2A is a more aggressive disease, ziftomenib may act as a 'great equalizer'.

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Travis Coy, CFO, acknowledged the uncertainty and stated the company is monitoring the situation. Since Chemtrec is manufactured in Europe, tariffs could have a non-immediate impact on COGS. To ensure patient supply continuity, the company has built up approximately 18 months of inventory in the United States.

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David Berman, Head of R&D, reiterated that data from three dose cohorts of 5-6 patients each will be presented, with dose escalation ongoing. He explained that in a Phase I trial for a novel therapy where no treatment has reliably worked, success is defined by seeing clear signals of activity, such as reservoir reduction or altered rebound kinetics. A better understanding of the rate of patient control will come from the expansion cohort later in the year.

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Chief Global Commercialization Officer Anthony Mancini confirmed the build-out of the US field team has begun, with MSL and thought leader liaison teams already in place, but did not provide specifics on size or future milestones. President of R&D Steve Kelsey clarified that the PRMT5 combo trial, sponsored by Tango, primarily targets pancreatic cancer due to the high overlap between RAS mutations and MTAP deletion in that tumor type.

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Dr. Mark Goldsmith, Chairman and CEO, explained that the pembrolizumab combination study is primarily focused on safety, specifically monitoring for the hepatotoxicity seen with first-generation RAS(OFF) inhibitors. For the RMC-6236 plus RMC-6291 RAS(ON) doublet, the focus is less on tolerability and more on observing qualitative evidence of enhanced anti-tumor activity that distinguishes the combination from monotherapy, mirroring preclinical findings.

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CMO Noah Berkowitz indicated that guidance on the timing for ARV-806 data would be provided soon, likely for release sometime next year, and noted that enrollment is progressing well. For the ARV-393 update in the second half of the year, he suggested focusing on standard dose-escalation metrics: safety, pharmacokinetics (PK), and early signs of efficacy, with a reasonable patient number estimate being in the 10-20 range.

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CEO John Houston described a plan for an "appropriately sized" sales force for a targeted launch to roughly 6,000 key oncologists under the 50-50 U.S. co-commercialization agreement. He stated unequivocally that Arvinas is committed to its Pfizer partnership and would not seek another partner, emphasizing that future decisions will be made jointly as more data becomes available.

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CMO Dr. Nick Botwood reported that the sNDA submission for NPM1 is progressing very well, with positive and consistent dialogue with the FDA and no indication of issues. CEO Michael Metzger reiterated that physicians aim to put the vast majority of eligible patients on maintenance therapy, a likelihood that increases with earlier treatment, but did not provide a specific percentage.

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Chief Scientific Officer Dr. Peter Ordentlich addressed the GVHD question, stating it is too early to comment on specific subgroup trends as real-world evidence is still being collected. CEO Michael Metzger commented on MSS-CRC, noting the trial is ongoing and the company is looking for prolonged stable disease, with an update expected later in the year.

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CCO Steven Closter confirmed anecdotal off-label use in NPM1 and combinations but stated it's too early to quantify. He clarified that all eligible EAP patients have been transitioned (a single-digit number) and the program is now only lightly used. He and CEO Michael Metzger affirmed that launch momentum remains strong, driven by post-ASH reviews and growing payer coverage.

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CEO Michael Metzger confirmed the $350 million from the royalty agreement provides a pro forma cash balance of approximately $750 million, enabling the company to aggressively advance its entire portfolio. He also detailed the NPM1 strategy: release pivotal data, publish it, and then submit for NCCN guidelines, which could precede formal regulatory approval for that indication.

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CFO Christopher Senner reiterated the company's long-standing position that clinical trial sales are 'choppy' and unpredictable. He stated that the company lacks sufficient line of sight to provide a reliable forecast for this revenue component.

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CFO Christopher Senner specified that clinical trial sales contributed approximately $12 million to revenue in the first quarter. The question regarding pricing power was not addressed in the provided transcript.

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President and CEO Michael Morrissey reiterated a point made earlier in the call, stating that the company's 'singular focus' is on the regulatory review and approval of cabozantinib for the NET indication. He confirmed that once that process is complete, the company will turn its attention back to the CONTACT-02 opportunity.

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President and CEO Michael Morrissey confirmed the CABOMETYX loss of exclusivity (LOE) is expected in the early 2030s. He reiterated that the provided slide illustrates zanzalintinib's potential for dramatic growth as pivotal trials read out, driving significant upside for the company.

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CEO Sushil Patel and CFO Emily Hill confirmed no significant gating factors remain, as manufacturing inspections are complete and feedback presents no bottleneck to the PDUFA date. Hill stated the company will provide launch metrics like patient numbers but will defer formal revenue guidance. CCO Christopher Sarchi added that RP1 is well-positioned as a first choice for patients failing PD-1 therapy, supporting rapid adoption.

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CEO Terry Rosen confirmed that plans for etrumadenant are not moving forward at this time. He stated the company's top priority is casdatifan, with the domvanalimab program's spending naturally winding down and the PRISM-1 trial expected to be fully enrolled in 2025. Regarding ASCO, Rosen explained the abstract was a placeholder and the oral presentation will feature a more recent data cut, including safety data for approximately 40 patients and efficacy data for about 25 patients.

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CEO Terry Rosen explained the timing is based on the data package delivery and Gilead's contractual review period, which spans the year-end. He stated that if Gilead doesn't opt-in, Arcus is comfortable proceeding alone but has also received inbound interest from other potential partners. CFO Bob Goeltz added details on the $150M opt-in fee and 50/50 cost share.

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CEO Terry Rosen explained that success for casdatifan would be defined by differentiation from belzutifan across several metrics, including response rate, rate of primary progression, and depth of response. He emphasized the program's goal is to combine casdatifan with a superior TKI. Regarding the Gilead opt-in, Rosen stated that a decision is expected toward the end of 2024 or early 2025.

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