Charles Duncan • Cantor Fitzgerald

Answer

Dr. Guy Goodwin (CMO) and Kabir Nath (CEO) clarified that the FDA was not the source of suicidality concerns, as it's a known feature of depression; rather, concerns arose from public commentary after the Phase IIb data release. Dr. Steve Levine (CPO) explained that HealthPort serves underserved populations and already delivers Spravato, making them a key partner for ensuring equitable access to new treatments.

Ask Fintool Equity Research AI

Answer

Chief Medical Officer Dr. Guy Goodwin explained that suicidal ideation is an inherent risk in a treatment-resistant depression population and is being systematically tracked. He stressed that Compass relies on the unblinded DSMB's clinical judgment to assess the data for any safety signals and confirmed that the company would be alerted if the DSMB had any concerns.

Ask Fintool Equity Research AI

Answer

Kabir Nath (Executive) confirmed the regulatory strategy remains unchanged. An unnamed executive (identified as Michael) stated that the antidepressant washout success rate is over 90% and not a logistical obstacle. Regarding the cash runway, Teri Loxam (Executive) reported a cash balance of $207 million, which is expected to fund operations at least into 2026, noting that savings from the announced restructuring are intended to offset the extended trial costs.

Ask Fintool Equity Research AI

Answer

CCO Jeffrey Del Carmen defended the FIRDAPSE guidance by citing consistent leading indicators and a stable patient pipeline. Regarding FYCOMPA, he acknowledged the 'stickiness' of anti-seizure medications, but CEO Richard Daly tempered expectations for 2026 due to likely increased generic competition. On business development, Mr. Daly emphasized the goal is to execute the 'right' transaction, not just any transaction, maintaining a discriminating approach.

Ask Fintool Equity Research AI

Answer

CEO Richard Daly and CCO Jeffrey Del Carmen explained that FIRDAPSE guidance is precise due to extensive experience with the product and a well-understood patient pipeline of over 500 diagnosed individuals. Del Carmen noted a steady, low annual discontinuation rate of 15% provides further confidence. Regarding capital deployment, Daly stated that while the FYCOMPA acquisition helped build cash reserves, the company's M&A focus remains on orphan and differentiated products, not necessarily in the retail epilepsy space unless the opportunity is also for a rare disease.

Ask Fintool Equity Research AI

Answer

CCO Jeffrey Del Carmen explained the strategies are distinct: FIRDAPSE requires a broad educational reach for a dispersed prescriber base, while AGAMREE is a highly targeted, competitive sale to about 100 centers of excellence. Executive Gary Ingenito detailed that the 5-year SUMMIT study is in site activation and aims to collect high-quality, long-term data on bone health, growth, and mobility to strengthen AGAMREE's label.

Ask Fintool Equity Research AI

Answer

An executive, likely Head of R&D Elizabeth Thompson, responded that based on existing data, no specific patient subsets have been identified as more or less likely to respond. CEO Catherine Owen Adams added that the R&D Day will provide a deep dive into all clinical-stage programs, including new data on their essential tremor program.

Ask Fintool Equity Research AI

Answer

EVP of R&D Elizabeth Thompson confirmed the existence of an open-label extension study with good patient rollover. She explained that while data is limited, studying the wide age range is important because Prader-Willi is a lifelong disease, and the trial is designed to understand the drug's impact across the full patient population.

Ask Fintool Equity Research AI

Answer

Executive Elizabeth Thompson confirmed that the current expectation is to release some data from the Phase II portion at an appropriate time. She added that the original plan always allowed for using Phase II data to make modifications to the Phase III studies as needed.

Ask Fintool Equity Research AI

Answer

President and CEO Dr. Mihael Polymeropoulos confirmed the DTC campaign for bipolar disorder is active and has received positive feedback, validating the promotional sensitivity of the market. He stated the upcoming Bysanti presentation will detail two pivotal bioequivalence studies. For Europe, he acknowledged a tough pricing environment but noted an appetite for long-acting injectables, confirming that Day 120 questions from the EMA have been received and are being addressed, leveraging Vanda's existing German presence.

Ask Fintool Equity Research AI

Answer

CEO Mihael Polymeropoulos explained that Fanapt's growth stems from prescribers treating bipolar disorder, a new segment for the drug. He described the sales force expansion to 300 representatives as a measured approach to ensure quality, while acknowledging potential competition. Dr. Polymeropoulos confirmed the DTC campaign targets bipolar I patients to raise awareness and noted that Bysanti's potential in MDD is supported by extensive data on its parent compound, iloperidone. Regarding imsidolimab, he stated that a pre-BLA meeting with the FDA provided confidence for a filing this year.

Ask Fintool Equity Research AI

Answer

CEO Mihael Polymeropoulos confirmed that the 90% increase in new-to-brand prescriptions (NBRx) is leading to growth in new (NRx) and total (TRx) prescriptions. He stated the sales force is not yet optimized as expansion continues to drive growth. He does not foresee a direct negative impact from Cobenfy, which is approved for schizophrenia, and believes it will renew interest in the therapeutic class. Dr. Polymeropoulos noted the milsaperidone NDA filing is gated by stability data expected in Q1 2025 and highlighted the significant opportunity in expanding to major depression. Executive Kevin Moran added that sales force interactions with prescribers increased three- to fourfold from Q1 to Q3.

Ask Fintool Equity Research AI

Answer

Fady Malik, EVP of R&D, confirmed the strategy is consistent across all jurisdictions. He explained that adding the MAPLE-HCM data to applications already deep into their review cycles would be disruptive, so the plan is to submit it as a supplementary filing after initial approvals are secured.

Ask Fintool Equity Research AI

Answer

EVP & CBO Isaac Ciechanover noted Sanofi's strong engagement and the clear unmet need in China, where there are no REMS programs. He confirmed milestones are tied to a potential approval this year. EVP & CCO Andrew Callos added that China is a concentrated market with about 400,000 diagnosed patients, primarily treated in just over 1,000 hospitals. President & CEO Robert I. Blum stated they could be eligible for up to $35 million in total milestones this year across all partners, tied to clinical and regulatory events.

Ask Fintool Equity Research AI

Answer

Bruce Cozadd, CEO, noted the product is already at a blockbuster run rate. Renée Galá, President and COO, detailed the growth drivers, including its differentiated profile, data on non-seizure benefits, strong momentum in the adult and long-term care settings, high-quality access, and a Nurse Navigator program that improves patient persistency.

Ask Fintool Equity Research AI

Answer

CCO Adam Zaeske and CEO Dr. Jeffrey Dayno confirmed strong momentum exiting Q1 underpins the full-year guidance, which is primarily demand-driven. Dr. Kumar Budur, CMSO, explained that initiating the large, global Phase III trials for pitolisant HD requires completing multiple steps, including final formulation work, protocol finalization, and regulatory submissions, all of which are on track for a Q4 start.

Ask Fintool Equity Research AI

Answer

Dr. Kumar Budur, Chief Medical and Scientific Officer, stated the trial is on track for Q3 2025 data. He confirmed enrollment includes patients with both complete and partial methylation, ages 3-30, with higher doses for patients over 50kg. Dr. Budur highlighted the "unprecedented" persistency in the long-term extension, with some patients on ZYN002 for over 8 years, suggesting durable effectiveness.

Ask Fintool Equity Research AI

Answer

Chief Commercial Officer Jeffrey Dierks stated that approximately 60% of new patients come from oxybate REMS-enrolled prescribers and 40% from non-oxybate prescribers. Chief Financial Officer Sandip Kapadia explained that the guidance range was already narrow and the company remains comfortable with it, expecting continued quarter-over-quarter growth.

Ask Fintool Equity Research AI

Answer

Ari Maizel, Chief Commercial Officer, reported that the SYMBRAVO sales team build-out of approximately 100 representatives is nearly complete, with a focus on high-volume migraine prescribers. Herriot Tabuteau, CEO, confirmed that the AHS meeting will be an important scientific venue for the company and that they expect to have a presence there.

Ask Fintool Equity Research AI

Answer

Chief Financial Officer Nick Pizzie stated the Auvelity sales team was expanded by approximately 40 representatives, a 10-15% increase, and confirmed expected synergies with Symbravo prescribers in primary care. Chief Operating Officer Mark Jacobson clarified the AXS-05 submission is gated by building the submission, not a stability time point, and is a top priority to be filed as early as possible in the second half.

Ask Fintool Equity Research AI

Answer

CCO Ari Maizel confirmed strong performance in both psychiatry and primary care, noting PCPs were the fastest-growing segment in Q3, and that rapidity of response is a key driver. CEO Herriot Tabuteau added that the high rollover rate into the AXS-05 open-label extension is a positive sign that helps meet safety exposure requirements for a potential NDA filing.

Ask Fintool Equity Research AI

Answer

Todd Nichols, Chief Commercial Officer, stated that LYBALVI's total prescriptions are split roughly 50/50 between schizophrenia and bipolar, with new patient starts trending higher for bipolar at 55%. CEO Richard Pops added that ALKS 2680 is also a true once-daily agent with dose flexibility and a wide therapeutic index, which contributed to positive data across all three patient populations in Phase 1b.

Ask Fintool Equity Research AI

Answer

CCO C. Nichols addressed the commercial questions, stating the sales force is expanding by approximately 80 representatives to maintain a competitive share of voice. CEO Richard Pops handled the pipeline question, explaining that both the NT1 and NT2 studies are enrolling well and that the company hopes they will finish around the same time in the second half of 2025.

Ask Fintool Equity Research AI

Answer

CCO Todd Nichols explained that LYBALVI's growth is strong in both bipolar I and schizophrenia, with new patient starts increasingly coming from bipolar I. He expressed confidence that LYBALVI's established profile and real-world evidence will be key differentiators against new entrants. CEO Richard Pops noted that potential indications for the orexin pipeline could span psychiatry, neurology, and even rare diseases, with specific development paths to be determined after early clinical characterization.

Ask Fintool Equity Research AI

Answer

President and CEO Gene G. Kinney asserted that given the lack of treatments for early mortality, any benefit meeting the SPA's p-value of ≤ 0.10 would be highly meaningful. COO Brandon Smith supported this, stating that market research confirms the unmet need is so profound that any statistically significant early survival benefit would drive strong interest from physicians and payers.

Ask Fintool Equity Research AI