François Brisebois • Oppenheimer & Co. Inc.

Answer

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.

Ask Fintool Equity Research AI

Answer

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.

Ask Fintool Equity Research AI

Answer

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.

Ask Fintool Equity Research AI

Answer

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.

Ask Fintool Equity Research AI

Answer

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.

Ask Fintool Equity Research AI

Answer

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.

Ask Fintool Equity Research AI

Answer

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.

Ask Fintool Equity Research AI

Answer

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.

Ask Fintool Equity Research AI

Answer

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.

Ask Fintool Equity Research AI

Answer

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.

Ask Fintool Equity Research AI

Answer

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.

Ask Fintool Equity Research AI

Answer

CEO Marcio Souza explained that if the interim shows overwhelming efficacy, results for both studies could be released simultaneously. More likely is a sample size increase for Study 1. On the commercial front, he described the GGE market as a multi-billion dollar opportunity, with modeling showing approximately 70% of the value in the U.S. and 30% ex-U.S.

Ask Fintool Equity Research AI

Answer

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.

Ask Fintool Equity Research AI

Answer

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.

Ask Fintool Equity Research AI