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CEO Nello Mainolfi stated the Phase 2b study aims to identify the optimal risk-reward profile by exploring both maximal and lower levels of degradation to inform the Phase 3 dose. Regarding the follow-on molecule, he explained it is an IND-ready asset that supports the franchise, provides strategic options for the future, and reinforces their competitive position, though there are no immediate plans to file an IND.

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President & CEO Jan Møller Mikkelsen stated that the situation is consistent with Q1 commentary and that improvements are expected in the latter half of the year as new initiatives are implemented. Jay Donovan Wu, EVP & President - US Market, detailed a multi-pronged approach, including payer education, optimizing hub processes to reduce paperwork cycles, and streamlining workflows with specialty pharmacies.

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President and CEO Jan Mikkelsen explained that they cannot precisely track patient control status as it is not part of the reimbursement process. However, he believes they are reaching a high percentage of uncontrolled and partly controlled patients due to a commercial strategy focused on endocrinologists with high patient visit frequencies. Chief Business Officer Sherrie Glass supported this, noting the large populations of uncontrolled (10k-15k) and partly controlled (30k-35k) patients ensure a steady flow of potential candidates.

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President and CEO Jan Mikkelsen characterized the U.S. pricing as 'responsible' and stated they have not received negative feedback. Regarding the European launch, he and an executive (likely CCO Camilla Harder Hartvig) noted they are pleased with the uptake, with ~250 patients and ~125 prescribers. They highlighted an 'extremely strong' 98% patient retention rate and stated the launch is benchmarking well against other rare disease launches, with switches from Natpar accelerating.

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CEO Kenneth Galbraith stated that ZW1528 is expected to advance rapidly, consistent with other pipeline assets. Regarding partnering, he explained that the company is not prioritizing any single asset, but rather has open discussions across its entire portfolio of six nominated candidates and is also exploring earlier-stage, broader collaborations.

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Chief Scientific Officer Dr. Paul Moore confirmed that learnings are definitely applied across the portfolio. He noted that the designs of ZW171 and ZW191 incorporated learnings from the broader field, and in turn, insights from these ongoing trials will inform the development of future programs. He indicated more details on trial design would be shared in upcoming 'trial in progress' posters.

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Chief Scientific Officer Dr. Paul Moore confirmed the R&D Day will cover specific autoimmune programs, not just platform potential. For the trispecific T-cell engager, he explained the design requires targets with tumor-biased expression and that its conditional CD28 engagement enhances safety, with encouraging preclinical tolerability for targets like DLL3 and Claudin 18.2.

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David Meeker, Chairman, President & CEO, explained that confidence in the 5,000-10,000 patient estimate for HO comes from literature, claims data from multiple countries, and field team validation, but was non-committal on providing a new formal estimate in September. CFO Hunter Smith noted that while ex-US growth is strong, Q3 can be seasonally slower in Europe and named patient sales are variable, though overall growth is expected to continue.

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David Meeker, Chairman, CEO, and President, stated that for the open-label RM-718 study, the company hopes to have enough patients treated for a sufficient duration to share data by year-end. Hunter Smith, CFO, clarified that patient compliance, typically in the low 80% range, was strong in Q4 2024 but returned to a more normalized level in Q1 2025.

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CEO David Meeker stated that the RM-718 SAD/MAD data will likely be released with the Part C update in the second half of 2025, noting that progress implies positive results. He also confirmed the Phase III HO trial has a roughly 50/50 split between adult and pediatric patients.

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Chairman, CEO and President David Meeker stated that the consistency of response in the French real-world data is reassuring and predicts well for a positive Phase III outcome. He could not specify which of the 5 patients were on GLP-1s but noted only 3 of the 8 total patients were on them, primarily for diabetes. He also acknowledged hearing anecdotal evidence of radiation-induced HO but confirmed the company has no firm estimates on that population's size.

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COO Karen Massey, with an introduction from CEO Tim Van Hauwermeiren, explained that the company does not provide a specific split by product presentation. She reiterated that Hytrulo drives the majority of growth and that the PFS strategy is focused on market expansion, not cannibalization, as evidenced by 50% of PFS patients being new to Vyvgart.

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Chief Executive Officer Tim Van Hauwermeiren clarified that the material consumption between cyclical and continuous dosing is net-net the same, so it is not expected to materially impact VYVGART dosing or offset Part D exposure. He emphasized that the significance of the ADAPT-NXT data is the ability to offer a full spectrum of individualized dosing, from cyclical to continuous, to best suit each patient's needs.

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Chief Operating Officer Karen Massey stated she expects continued momentum in MG by moving into earlier treatment lines and broadening the prescriber base. She confirmed that Q1 seasonality, driven by insurance benefit re-verification, is an industry-wide phenomenon to consider, referencing the company's 6% growth in the prior year's Q1 as an example.

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COO Karen Massey explained that while market research shows 88% of CIDP patients experience residual symptoms, switching is a significant decision. She highlighted that the most compelling factors for patients and physicians are VYVGART's novelty as the first innovation in decades, the large trial data, the high response rate, functional improvements, and the favorable safety and low treatment burden profile.

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CEO Michael Morrissey declined to give forward-looking quarterly guidance. EVP of Commercial P.J. Haley confirmed they are seeing broad prescription uptake from both academic and community settings, as well as from both new and existing cabozantinib prescribers, indicating widespread market activation.

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Chief Medical Officer Amy Peterson expressed high confidence in the study, noting it's the first Phase III trial in this specific patient population. She stated the comparator is sunitinib, which has a reported PFS of about 5-6 months. She highlighted that since cabo/nivo has beaten sunitinib and zanzalitinib is believed to be superior to cabozantinib, the trial has a high probability of success.

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Executive Timothy Sullivan stated that Apellis is not changing its guidance on cash runway or profitability. He characterized the Q1 revenue impact as transient, related to inventory and a shift to samples. He reiterated that the company expects 2025 operating expenses to remain in line with 2024 and anticipates the upcoming launch of EMPAVELI in C3G will meaningfully contribute to the top line, maintaining the path to profitability.

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CFO Tim Sullivan stated that 2025 operating expenses are expected to be 'more or less the same' as 2024, with increased R&D spending offset by other cost savings. He did not guide on gross margin but noted the estimated Q1 sample increase is approximately 5,000 vials, which analysts can use to model the revenue impact.

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CFO Timothy Sullivan explained that the company is already near breakeven on a cash operating expense basis. He clarified that monetizing receivables is a working capital tool to bring in their own cash sooner, not a primary funding strategy. He stated that with their current expense structure and the upcoming C3G launch, it does not take significant growth for the company to become cash flow positive.

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CMO Noah Berkowitz addressed known class-related safety concerns for LRRK2 inhibitors, stating that Arvinas's degrader has shown a differentiated and more favorable preclinical safety profile. He expects the upcoming patient data to show a greater than 50% LRRK2 reduction, similar to what was seen in healthy volunteers, but from the higher baseline levels characteristic of PD patients.

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Chief Medical Officer Noah Berkowitz stated that while data from TACTIVE-U is maturing, no specific guidance on timing is available. The choice of a second-line CDK4/6 partner is not solely dependent on this data, as vepdegestrant has shown good combinability with multiple agents. Chief Scientific Officer Angela Cacace explained that preclinical and genetic data suggest a 50% reduction in LRRK2 protein is the therapeutic target, which the company aims to demonstrate in the central nervous system.

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An unnamed executive explained that while tryptase is being measured for INCB00262, the reduction is not expected to be as dramatic as with mast cell-depleting antibodies due to its targeted action on mast cells in the skin. Another executive confirmed that Jakafi's MF market is growing overall, with a 4% increase in total patients, as patients are being started on therapy earlier and treated in later lines of therapy more frequently.

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President and CEO Stephen Mahoney clarified that the BLA timeline is primarily driven by the need to complete the follow-up period for the THRIVE 2 trial, not STRIVE. He explained that STRIVE is designed to fit within that timeline and that a data cut can be taken once the required safety database number is reached. He also confirmed that VRDN-003, as a different molecule, will require its own safety database.

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