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An executive, James Brown, estimated the Phase III trial would cost approximately $20 million and take about two years to reach top-line data. Brown, along with executives Norman Sussman and Weiqi Lin, explained that the time-to-dose variation is critical in an acute disease like alcohol-associated hepatitis. They noted that U.S. patients were treated much faster (around 4 days) than in some ex-U.S. regions (up to 2 weeks), which significantly impacted outcomes. The upcoming Phase III trial will control for this by ensuring all patients are dosed within approximately 9 days.

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The company expects FDA minutes in about 4+ weeks and will provide an update then. They acknowledged significant regional differences in patient management that explain the data variance between the U.S. and EU. Liver transplant is not a major factor due to scarcity, so the focus remains on mortality. The AASLD meeting is in San Diego. The Oxford loan terms were detailed, including monthly payments, interest rate, and final payment date.

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Executive Barry Wolfenson clarified that the new Medicare LCD, effective April 2025, heightens the requirement for complete debridement and granulation tissue before CTP use, which strongly positions EscharEx as an optimal choice. CEO Ofer Gonen explained the trial's interim assessment is expected by mid-2026. The outcomes could be stopping enrollment early due to a high probability of success or adding a few dozen patients to maintain the study's 90% statistical power.

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Dietrich Pauls, an executive, confirmed a 'very encouraging' increase in enrollment since the start of the year, partly due to the protocol amendment. He added that the failure of three competing mechanical thrombectomy studies at the IST conference was viewed positively by KOLs, as it reduces competition for patients and may increase site capacity for the ReMEDy2 trial.

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CEO Dietrich Pauls stated that with the interim analysis results now expected in Q4 2025, the company anticipates completing the enrollment of the 200-patient cohort sometime in the summer of 2025.

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Chief Commercial Officer Jaime Xinos projected a slow initial sales ramp, with a focused strategy targeting the top 10% of varenicline prescribers and highly motivated patients. CEO Richard A. Stewart reiterated that while the company is planning for a self-launch, it remains open to a strategic partner to optimize U.S. revenue and global expansion. Chief Financial Officer Mark Oki clarified the fully diluted share count, estimating it would add approximately 20 million shares from options and warrants.

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CEO Rick Stewart outlined the sequential process following the completion of 6-month data collection for 300 patients. He stated the company must monitor the data, incorporate it into the Integrated Safety Summary (ISS), insert the ISS into the NDA, and then conduct a full quality control check on the entire NDA package before submission.

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Executive Sherry Korczynski described the planned Q1 2026 launch as 'perfect timing' ahead of the peak allergy season. CEO Daniel Barber defended the product's safety, highlighting a robust data package and arguing a strong second dose is critical for severe reactions. Executive Carl Kraus added that the epinephrine levels are within the body's capacity to handle stress and do not pose a concern.

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CEO Daniel Barber emphasized that the OASIS study data is a key differentiator that physicians are paying attention to. Chief Medical Officer Carl Kraus added that KOLs widely support the idea that localized delivery holds promise and that the study provides a potentially predictive model for evaluating anaphylaxis. Barber clarified that literature shows about 10% of OAS reactions progress to more severe reactions, with 2% of total OAS cases resulting in anaphylaxis.

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Executive Gregory Divis detailed a 15% increase in the sales team to 53 reps and a doubling of both the field support and nurse teams to 28 each, effective January 2025. He confirmed increased investment in patient education media channels. Divis clarified that field support teams assist physician offices with post-prescription logistics, while nurse teams engage directly with patients. He emphasized that a cumulative, multi-faceted approach is necessary to drive patient switches. Executive Thomas McHugh added that these investments are already showing positive early trends in Q1 2025.

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Executive Richard Kim explained that step-throughs are rare due to strong payer access, with 85% commercial coverage secured. He noted the sales force is expanding by just over 10% to increase reach with moderate and low-volume prescribers. CFO Thomas McHugh commented on Q4 expectations, highlighting the need to assess new patient persistency and seasonality. CEO Gregory Divis provided a detailed legal update on the Delaware patent trial, the IH injunction appeal, and the antitrust action against Jazz.

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Chief Patient Officer Dr. Steve Levin and CEO Kabir Nath explained the CPO role is to integrate patient and provider perspectives into all strategic planning. Nath reiterated that the COMP005 26-week data readout is gated by the completion of Part A of the COMP006 trial. He also confirmed the last DSMB review occurred in February 2025 and that future reviews would follow a quarterly cadence, depending on the final data release timing.

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Lori Englebert (Executive) highlighted the company's current pre-commercial activities. These include increasing awareness of TRD, educating KOLs on Phase II data, preparing for state-level DEA rescheduling, optimizing patient flow models through collaborations, and building a robust health economics dataset for future payer discussions. She reiterated confidence by citing Spravato as a successful market analog.

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Chief Commercial Officer Aziz Mottiwala detailed a four-part strategy to deepen prescribing habits, citing near-term drivers like the expanded sales force and 90% insurance coverage, and mid-to-long-term drivers like the DTC campaign and compelling MGD data. An executive added that the retreatment rate is currently in the mid-single digits but is expected to reach a steady state of 20%. Chief Financial Officer Jeff Farrow confirmed that impacts from LA fires and winter storms were factored into Q1 guidance.

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Chief Medical Officer Dr. Elizabeth Yeu stated she joined to amplify her ability to care for patients on a larger scale, citing Tarsus's excellence in execution and its inspirational leadership team. CEO Bobak Azamian added that her leadership in evidence and education is timely. Regarding M&A, Azamian said the focus remains on XDEMVY, but the company is preparing to leverage its platform to add both development-stage and commercial assets over time to become a broader eye care leader.

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Executive Shawn O'Connor explained that the large pharma commitment was not a surprise but the result of a sustained, long-term business development effort. Regarding the Services segment, he stated that while client budget constraints at the end of the calendar year caused some project ramp-up delays, robust bookings and a strong backlog provide confidence in the full-year outlook, and the company's guidance already factors in this dynamic.

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Executive Shawn O'Connor clarified that the incremental $4 billion TAM from Pro-ficiency is split between the market for clinical trial training services and the medical communications market, which includes pre-approval regulatory support and post-approval commercialization work. Regarding M&A, he stated that while resources are devoted to the current integration, the company's strategy to supplement organic growth with acquisitions is unchanged and remains active, though there is no specific guidance for a deal in 2025.

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Executive Robert Barrow confirmed that the company intends to lock the database and announce top-line results for Part A upon its completion after 12 weeks. He clarified the interim analysis is a blinded sample size reestimation with no inferential testing for early efficacy or futility. Regarding the election, he noted broad, bipartisan awareness and enthusiasm for addressing the mental health crisis.

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CEO Marcio Souza outlined that if the study is stopped for overwhelming efficacy, results for both Study 1 and Study 2 would be released simultaneously. He also noted the most probable scenario is an increase in Study 1's size. Regarding the DEE market, he described it as a multibillion-dollar opportunity, with modeling showing approximately 70% of the value in the U.S. from a patient population just under 200,000.

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CEO Marcio Souza explained that for the relutrigine readout, the focus would be on the distribution of patient responses and the drug's very good tolerability, with a full discussion to follow. Regarding the Essential3 design, he detailed that the randomized withdrawal portion mimics real-world use, while the parallel group study leverages learnings from Essential1 to manage a heterogeneous population, creating a robust registrational package for a planned NDA filing.

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Executive Marcio Souza did not directly confirm if a p-value would be shared for the relutrigine readout, instead emphasizing the importance of the distribution of patient responses and the drug's very good tolerability. Regarding the Essential3 design, he explained that the randomized withdrawal study mimics real-world use, while the parallel group study leverages learnings from Essential1 to manage a heterogeneous population, with the overall goal of maximizing the probability of success for a future NDA filing.

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Chief Commercial Officer Jeffrey Dierks reported that concomitant use with oxybate has remained consistent in the low double-digits (teens) with stable reimbursement. He noted that rare disease categories are typically less managed by payers and suggested that future enhanced-efficacy products like pitolisant HD could potentially reduce the need for controlled substances, a positive for both patients and payers.

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President & CEO Dr. David Young explained that a longer DPD inhibition, closer to 72 hours, would be ideal for NGC. He clarified that under Project Optimus, the company plans for a single Phase 2B trial before a pivotal trial, similar to other indications. For gastroparesis, he highlighted the significant unmet need in moderate to severe patients and noted that PCS12852's safety profile could allow for doses higher than 0.5mg. Dr. Young also acknowledged recruitment difficulties for PCS499 due to a small patient population and frequent misdiagnosis prior to screening.

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President and CEO Dr. David Young clarified that for PCS499, the issue is not a high screening failure rate but a low volume of patients presenting for screening, which he attributed to COVID-19 concerns. He noted that supplemental recruitment programs and the new website are beginning to increase patient interest. For PCS6422, Dr. Young projected interim results for the new cohorts in late summer (August/early September), with the overall study timeline remaining on track to complete enrollment by the end of 2022.

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President and COO Todd Bazemore explained the initial restrictions were a standard payer tactic for a non-contracted drug gaining momentum, which was resolved by negotiating a formulary contract. He anticipates significant gross-to-net improvements in the second half of 2022. While granular filled vs. written data has a lag, he noted that a drop in copay assistance use from 70% to 54% alongside accelerating script growth are positive indicators. Head of R&D and CMO Kim Brazzell described the PCED landscape, identifying Dompe's OXERVATE as the only approved competitor but with a narrower indication (neurotrophic keratitis) and a more complex administration process compared to KPI-012's broader, more convenient approach.

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COO Todd Bazemore clarified that EYSUVIS revenue increased 10% quarter-over-quarter, while volume grew 19%, with the difference due to higher utilization of the co-pay assistance program to capture more rejected scripts. He positioned OXERVATE's ~$100,000 price as a good analog for rare disease pricing. Chief Medical Officer Kim Brazzell explained that PCED results from various underlying conditions, such as neurotrophic keratitis, viral infections, or surgical issues, that impair the cornea's ability to heal.

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CEO Douglas Drysdale detailed the dosing schedule: patients receive the first dose at time zero, with an initial assessment at week 3. At that point, the active group receives a second dose, and the placebo group receives its first dose. A final assessment occurs at week 6, allowing for a comparison between one and two doses. While he confirmed the 3-week interval between doses, he also suggested that longer-term follow-up is being considered but could not share specifics at this time.

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CEO Doug Drysdale explained that MDD represents a larger population and a less risky initial path to proof-of-concept than TRD. He noted they use a secondary screening tool to mitigate placebo effects. He clarified that scalability is a multi-pronged strategy, combining the shorter clinic time of CYB003 for better adoption with the open-source EMBARK program to ensure a supply of trained therapists.

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