Sumant Kulkarni • Canaccord Genuity LLC

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CEO Neil McFarlane and CCO Joshua Schafer detailed their strategy to grow enrollments by targeting diagnosed-but-untreated and undiagnosed patients, citing Europe's mature market as a model and Myclifa's 5-year durability data as a key differentiator. For the DISCOVER trial, Chief Medical Officer Adrian Quartel highlighted a new genetic testing initiative and strong physician interest, expressing optimism for improved enrollment outcomes in the coming quarter.

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Chief Commercial Officer Joshua Schafer stated that while the exact number isn't disclosed, the majority of the 122 enrollments are on active drug, with others in the benefits investigation process. He explained that initial denials are typical for rare disease drugs and are usually overcome through medical exception processes, leveraging MIPLYFFA's strong clinical data. President and CEO Neil McFarlane added that the product's differentiated clinical profile is key to overcoming access challenges. Regarding celiprolol, Mr. McFarlane confirmed the trial size and detailed new strategies to accelerate enrollment, such as focusing on genetically confirmed patient centers, expressing confidence that these efforts will increase the enrollment rate.

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CCO Joshua Schafer explained the initial enrollment surge was driven by ready-to-go EAP patients and future growth depends on expanding to new sites. CEO Neil McFarlane added that the rapid EAP conversion far exceeded typical timelines. Regarding OLPRUVA, Schafer stated no specific timeframe for an inflection has been set, but emphasized the strategic synergies the product creates for the commercial team.

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President and CEO Neil McFarlane stated they are not parsing approved prescriptions by EAP status and declined to comment on competitors, instead emphasizing MIPLYFFA's differentiated data showing it halts disease progression. Chief Commercial Officer Joshua Schafer explained the search for a partner for KP1077 is driven by the need for a larger commercial footprint than Zevra's rare disease focus. Neil McFarlane described patient demand for the celiprolol trial as a 'big surprise' with very strong interest since restarting enrollment.

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EVP, Head of R&D, Elizabeth Thompson, explained that ACP2591 was attractive due to mechanistic similarities to Daybue, which de-risks it, but with the potential for a differential benefit-risk profile. She stated that the company is currently conducting additional work to verify information needed to advance the program specifically in Rett syndrome and will provide updates at an appropriate time.

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CFO Mark Schneyer reiterated that the intellectual property for NUPLAZID provides protection within a window of October 2030 to February 2038, and noted an upcoming oral argument for a patent appeal. CEO Catherine Owen Adams confirmed that the company is establishing the mechanism for France's early access program and plans for those patients to transition to commercial product after national reimbursement is secured.

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EVP of R&D Elizabeth Thompson acknowledged the evolving regulatory environment but stated that Acadia has not yet seen any impact on its interactions with the FDA. She confirmed that the timing and tenor of discussions have remained consistent, and the company will continue to monitor the situation closely.

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Executive Brendan Teehan identified the primary focus as education on real-world efficacy, especially outside of academic centers. The key variable to drive inflection is effectively translating clinical trial endpoints (CGII, RSBQ) into tangible daily improvements for families and physicians. This is being done through peer-to-peer programming and sharing caregiver testimonials about long-term benefits, tailored to different patient age groups.

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CEO Kabir Nath stated it is premature to speculate on a filing date before meeting with the FDA. He clarified that the Part B data from COMP005 will be released only after COMP006 Part A is complete to avoid data confounding. He also confirmed the priority review application was a 350-word abstract and contained no new, non-public Phase III data.

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Dr. Guy Goodwin, Chief Medical Officer, stated that determining the time frame for suicidality attribution is complex and that they will need to analyze the data before making any predictions. CEO Kabir Nath reported no changes in their routine day-to-day interactions with the FDA, although they are monitoring higher-level shifts that could create favorable tailwinds for the field.

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CEO Kabir Nath and CMO Dr. Guy Goodwin argued that the efficacy bar for TRD is likely lower than for MDD due to the lack of approved treatments. Chief Patient Officer Dr. Steve Levin addressed competition by highlighting new CPT codes that reimburse on an hourly basis, supporting the economic model. CEO Kabir Nath described the political environment as neutral to potentially positive, particularly for PTSD, but noted no change in FDA interactions yet.

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Kabir Nath (Executive) reiterated that the company has consistently guided to a 6-week data release for COMP 005, highlighting that its design is different from COMP 006, where blinding is a higher priority. Lori Englebert (Executive) affirmed her belief that the Phase III program will provide important and relevant information on treatment schedules that will be valuable for discussions with payers regarding pricing.

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Strategic Advisor Eiry Roberts acknowledged the encouraging data and the company's deep expertise in CRF biology. She stated that Neurocrine is considering a broad range of potential indications for the mechanism and has other research programs that could also address challenging diseases like obesity.

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Chief Financial Officer Matthew Abernethy and CEO Kyle Gano both declined to provide a peak sales forecast. Abernethy pointed out that original models were for $500 million, a figure the drug nearly achieved in year-over-year growth alone in 2024. Gano added that the underlying prevalence of tardive dyskinesia is growing, making the market size dynamic and suggesting significant growth potential remains as 9 out of 10 patients are still untreated with a VMAT2 inhibitor.

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