Yasmeen Rahimi • Piper Sandler & Co.

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CEO Matt Gline expressed hope that the data will highlight a 'paradigm-shifting opportunity' for Graves' patients by demonstrating that remission is achievable for severe, refractory cases. He outlined the data's threefold importance: defining the commercial opportunity, boosting patient and physician enthusiasm for trial enrollment, and strengthening the drug's overall clinical profile.

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CEO & Director Matt Gline stated that the company has not yet disclosed the study's statistical powering but may share more in the coming months. He justified the 600mg dose by referencing data from the batoclimab study showing deeper IgG suppression leads to better outcomes. He argued that in a severe disease like CIDP and a competitive market, maximizing efficacy with the highest dose is paramount for success and will also aid in trial enrollment.

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CEO Anish Bhatnagar declined to provide post-quarter data but affirmed confidence in VICAT XR becoming the standard of care. CCO Meredith Manning explained that the time-to-fill is variable as more payer policies are established. While encouraged by the 33% of lives covered, she noted that as more policies are added, turnaround times could fluctuate before settling toward a target of approximately 30 days.

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Executive James MacKaness advised that Q2 revenues are expected to be modest due to the multi-step conversion process and cautious inventory building by specialty pharmacies. CCO Meredith Manning added that while it is too early to provide specific metrics, the current turnaround time is consistent with other rare disease launches.

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CEO Bill Sibold stated that Madrigal expects its growth trend to continue, having planned for all scenarios, including the semaglutide launch. He noted that step-edits are complex for patients with comorbidities and it's too early to know specifics. CFO Mardi Dier added that combination use is already common, with about 50% of ResDiffera patients having current or prior exposure to GLP-1s, a dynamic that is already factored into their performance.

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CEO William Sibold noted that while it is still early for definitive data, all early signs point to promising adherence rates consistent with other well-tolerated oral therapies. He attributed this to the drug's favorable profile and the positive biomarker feedback physicians are sharing with patients, which encourages continued use.

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CFO Mardi Dier reiterated that the company is not providing formal guidance at this time as it is too early in the launch. However, she extended her positive commentary to the full year, stating that based on current momentum, they expect the full-year 2025 consensus to also narrow and increase slightly.

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CEO William Sibold stated the launch is tracking well against top-tier specialty medicine benchmarks, which typically see around 50% growth in the third quarter of a launch. CFO Mardi Dier added that while specific 2025 guidance is not yet available, they anticipate that expectations for 2025 will increase to reflect the current robust growth.

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President & CEO Marcio Souza confirmed robust efficacy across various background therapies, including on top of cenobamate, highlighting the refractory nature of the patient population. He attributed strong recruitment to their effective operational engine, which is already being applied to POWER-one, and reiterated guidance for completing that study by year-end.

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CEO Marcio Souza clarified that the interim analysis timeline was adjusted to safeguard the overall program's success and prevent any potential negative influence on the Study 2 readout. He added that the company is preparing for a potential Phase II/III study in Parkinson's disease, leveraging prior FDA feedback, to be ready for initiation following the essential tremor results.

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CEO Marcio Souza confirmed that Essential3 enrollment remains on track and the interim analysis was planned from the outset as an 'insurance policy' to potentially increase sample size if needed, thereby maximizing the probability of success. He explained that the RADIANT study for PRAX-628 will provide crucial intermediate safety, PK, and efficacy data, helping to characterize the drug in an epilepsy population and serving as a first step into generalized epilepsy, all of which will support the overall registration package.

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CEO Faheem Hasnain stated that enrollment will complete by mid-June and the current baseline data is not expected to materially change. CMO Dr. Richard Aranda clarified that while there was a PVR entry criterion, it is not an endpoint. Dr. Aranda also suggested a positive PROSERA result would be a positive indicator for the PH-ILD study, as those patients are generally sicker, fitting the thesis that seralutinib is effective in more severe populations. Faheem Hasnain added that seralutinib's potential antifibrotic properties are a key differentiator for PH-ILD.

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An executive, likely CSO Dr. Scot Roberts, confirmed that the IMPACT trial's baseline demographics are very similar to other MASH studies. CBO Ray Jordt explained the target population is MASH with obesity, leveraging the drug's dual action on the liver and weight loss. Jordt also stated that while Altimmune is open to compelling partnerships, moving to Phase 3 is not contingent on securing one.

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CMO Dr. Scott Harris explained that while Altimmune is at the forefront of using NITs like MRI-PDFF, the FDA's future acceptance of them as endpoints is uncertain. He noted strong internal interest in a cirrhosis study but stated that any disclosure would likely occur around the end-of-Phase II meeting, expressing high confidence in pemvidutide's potential success in the F4 population.

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CEO Dr. Vipin Garg described the FDA alignment as a "very important milestone" that provides clarity for potential partners. He explained the new indications leverage glucagon's benefits and will be detailed after regulatory clearance. CMO Dr. Scott Harris added that while the VELOCITY trials would ideally run in parallel, the exact sequencing is still under review.

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Dr. Alan Krasner, Chief Endocrinologist, explained that the study is very highly powered to detect significant differences. He clarified the endpoint is a composite responder analysis, not a co-primary endpoint. Regarding Cohort 4, he stated that it is currently enrolling and he could not yet comment on the timing of data availability.

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CEO R. Struthers stated that the communication cadence with the FDA is good. Chief Medical and Development Officer Dana Pizzuti confirmed that the mid-cycle review has not yet occurred but is scheduled, and the overall NDA review is proceeding normally with a productive relationship with the agency.

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Chief Endocrinologist Dr. Alan Krasner outlined an oncology-style Phase I dose-escalation study in patients with progressing SST2-expressing tumors, followed by dose expansion cohorts. CEO R. Struthers added that the market size is significantly larger than the carcinoid syndrome population (which is ~20% of NETs) and could potentially expand to other SST2-expressing cancers.

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CFO Mark Hahn stated that the gross-to-net discount was 'well below 20%' in Q1 and is beginning to stabilize with little room for further dramatic improvement. CEO David Zaccardelli added that while Q1 growth was blunted by industry-wide seasonality, the company expects substantial continued growth driven by an expanding prescriber base and a 'stacking phenomenon' of new and refilling patients. He emphasized that the launch is still in its early stages with plenty of room to grow.

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Mark Hahn, Chief Financial Officer, stated that the gross-to-net discount was 'well below 20%' in Q1 and is beginning to stabilize. CEO David Zaccardelli added that while Q1 growth was blunted by industry-wide seasonality, he expects substantial continued growth driven by a 'stacking phenomenon' of new patient starts and strong refills, noting the launch is still in its early stages with significant room to grow.

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Executive David Zaccardelli responded that the company does not foresee specific market or competitive headwinds due to the significant unmet need in COPD, identifying standard operational execution (manufacturing, regulatory) as the primary risk-management focus. Regarding Europe, he clarified that the current strategy is to advance the regulatory process in the EU and UK to strengthen their position for partnering discussions, not to establish their own commercial operations.

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Executive David Zaccardelli called it premature to give 2025 guidance but expects an 'enormous year of growth.' He confirmed that nearly 50% of prescriptions are for patients already on triple therapy, but use is broad across all patient types. Chief Commercial Officer Chris Martin added that the commercial focus remains on increasing the frequency of interactions with their 14,500 Tier 1 and Tier 2 physicians to accelerate adoption.

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CEO David Zaccardelli stated that while the company aims for transparency, the specific metrics shared will evolve as the launch matures. He highlighted the strong early momentum, with over 100 healthcare providers (HCPs) prescribing Ohtuvayre within the first few days of launch, indicating significant initial uptake.

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Robert I. Blum, President and CEO, firmly rejected the term "mishap," characterizing the events as a normal part of the iterative FDA review process. He stressed that the FDA's request does not reflect any new safety concerns but rather a shift in how the risk will be managed—formally through a REMS rather than just labeling, without changing the underlying differentiated profile of aficamten.

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EVP of R&D Fady Malik commented that the ODYSSEY baseline characteristics were not surprising, showing patients with significant symptoms, elevated biomarkers, and reduced exercise capacity. He noted the striking similarity to oHCM patients, which he believes bodes well for the potential effectiveness of CMIs in this population. He also highlighted that the rapid enrollment in both trials indicates nHCM is a significant unmet need.

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Andrew Callos, EVP and CCO, cited market research indicating ~25% of patients have contraindications and 80-90% experience side effects with beta-blockers. He explained the value argument for aficamten would be elevated beyond cost to focus on superior outcomes (e.g., KCCQ, NYHA class, avoiding surgery), with the MAPLE trial serving to expand the prescriber market.

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Executive Peter Salzmann confirmed that a key benefit of the trial design is the ability to disclose data from the open-label period, creating a catalyst. He stated the trial is fully powered for its primary endpoint. Dr. Peter Taylor added that achieving DAS28 remission is 'enormously meaningful' for these patients and that other metrics could be even more impressive.

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Executive Peter Salzmann confirmed that the open-label design allows for data disclosure before the full trial readout, calling it a 'nice side benefit.' He affirmed the trial is fully powered for its primary endpoint. Dr. Peter Taylor added that outcomes like DAS28 remission are 'enormously meaningful' for this patient population and that other metrics could be even more impressive.

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