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    David HoangDeutsche Bank

    David Hoang's questions to Avadel Pharmaceuticals PLC (AVDL) leadership

    David Hoang's questions to Avadel Pharmaceuticals PLC (AVDL) leadership • Q2 2025

    Question

    David Hoang from Deutsche Bank asked for the current patient mix between switch and naive users and the desired future trend. He also sought details on what the increased commercial investment aims to achieve with prescribers, specifically regarding depth versus breadth of prescribing.

    Answer

    COO Susan Rodriguez stated that over half of current patients are switch patients. She described a consistent adoption cycle where new prescribers start with switch patients and then rapidly expand to new and discontinued patients. She noted growth comes evenly from both increasing depth with existing prescribers and expanding the breadth of the prescriber base. CEO Gregory Divis added that investments also target patient activation.

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    David Hoang's questions to Avadel Pharmaceuticals PLC (AVDL) leadership • Q1 2025

    Question

    David Hoang of Deutsche Bank inquired about the patient mix in Q1, specifically if there was a better mix of switch versus new-to-oxybate patients. He also asked about the tactics used to improve persistency and if there was room for further improvement.

    Answer

    CEO Gregory Divis confirmed that all patient segments improved, with an acceleration in switch patients, driven by expanded commercial reach. On persistency, he credited the expansion of the nursing support team, which allowed for more in-depth patient engagement, particularly in the first 90 days of treatment. He affirmed that there is still room to improve this metric further. CFO Thomas McHugh added that the company has reached a critical mass where every new patient contributes to profitability.

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    David Hoang's questions to Avadel Pharmaceuticals PLC (AVDL) leadership • Q4 2024

    Question

    David Hoang from Deutsche Bank requested specifics on the initiatives aimed at improving persistency for naive or new-to-brand patients and asked about the expected long-term persistency rates for LUMRYZ compared to twice-nightly oxybates.

    Answer

    Executive Gregory Divis reiterated the company's three-pronged persistency strategy involving direct engagement with patients via nurses, communication with physician office staff, and support from pharmacy partners. He stated that while LUMRYZ persistency rates are already superior to legacy twice-nightly products, the company is actively working to improve them further. Positive early results from these initiatives are expected to increase net patients on therapy and drive revenue.

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    David Hoang's questions to ACADIA Pharmaceuticals Inc (ACAD) leadership

    David Hoang's questions to ACADIA Pharmaceuticals Inc (ACAD) leadership • Q2 2025

    Question

    David Hoang asked about the open-label extension for the ACP101 Phase 3 study, specifically regarding the rollover rate, and whether the company would consider adding a randomized withdrawal design.

    Answer

    EVP, Head of R&D, Elizabeth Thompson, noted that there has been good interest in the open-label extension. She explained that the company is currently focused on the parallel-arm study because a positive result would clearly demonstrate what to expect upon therapy initiation. While a randomized withdrawal study could be considered in the future, the current parallel-group design is the immediate priority.

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    David Hoang's questions to ACADIA Pharmaceuticals Inc (ACAD) leadership • Q1 2025

    Question

    David Hoang of Deutsche Bank asked whether the 12-month persistency rate for DAYBUE could be improved or if the focus should be on adding new patients. He also inquired about the commercial positioning of Acadia's Prader-Willi asset against a competitor's recently launched product.

    Answer

    CCO Thomas Garner stated that the 12-month persistency rate of over 50% is expected to remain stable, and the primary commercial focus is now on driving new patient starts. Regarding Prader-Willi syndrome, executives noted the market has significant unmet need with room for multiple therapies with different mechanisms, and they see potential for combination therapy in the future.

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    David Hoang's questions to Harmony Biosciences Holdings Inc (HRMY) leadership

    David Hoang's questions to Harmony Biosciences Holdings Inc (HRMY) leadership • Q2 2025

    Question

    David Hoang from Deutsche Bank asked for details on the data expected in the Fragile X top-line release, including visibility on patient methylation status and the subsequent filing strategy. He also inquired about the factors influencing the upper versus lower end of the full-year Wakix revenue guidance.

    Answer

    Chief Medical & Scientific Officer Dr. Kumar Budur stated the top-line release will include standard demographic, safety, and efficacy data, and a positive result would prompt a rapid pre-NDA meeting and submission. For Wakix, EVP & CCO Adam Zaeske highlighted strong patient adds and broad payer coverage as key drivers. CFO & CAO Sandip Kapadia added that underlying demand is the primary driver, with typical factors like patient adds, gross-to-net, and trade inventory influencing the final position within the guidance range.

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    David Hoang's questions to Harmony Biosciences Holdings Inc (HRMY) leadership • Q1 2025

    Question

    David Hoang asked about the potential timeline for an NDA filing for ZYN002 in Fragile X if data is positive, and what the commercialization strategy and value proposition for the product might look like.

    Answer

    Dr. Kumar Budur, CMSO, stated that with positive data, they would file the NDA 'as soon as possible' and expect a priority review. CEO Dr. Jeffrey Dayno added they would move 'swiftly' and outlined a 'centers of excellence' commercial model to target the ~80,000 U.S. patients, leveraging deep engagement with the patient community.

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    David Hoang's questions to Harmony Biosciences Holdings Inc (HRMY) leadership • Q4 2024

    Question

    David Hoang asked about the rationale for studying fatigue and sleep inertia with Pitolisant HD and if these would be pursued for labeled indications. He also inquired about the planned design for the first-in-human study of their orexin 2 receptor agonist.

    Answer

    CEO Dr. Jeffrey Dayno explained that sleep inertia is a key symptom in IH, making it a focus for a differentiated label. Dr. Kumar Budur, Chief Medical and Scientific Officer, added that the goal is to get these symptoms into the label. Regarding the orexin agonist, Dr. Budur confirmed an IMPD submission is planned for mid-2025, with first-in-human studies in H2 2025, but did not detail the specific study design.

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    David Hoang's questions to Praxis Precision Medicines Inc (PRAX) leadership

    David Hoang's questions to Praxis Precision Medicines Inc (PRAX) leadership • Q2 2025

    Question

    David Hoang from Deutsche Bank asked about the strategic intent behind adding a mood endpoint and launching the POWER-three monotherapy study, focusing on how these initiatives could enhance the drug's label and differentiation.

    Answer

    President & CEO Marcio Souza explained the mood endpoint targets a potential label claim. He positioned the POWER-three study as a 'game changer' to establish vormetragene as an early-line therapy, aiming to significantly expand the market opportunity beyond the highly refractory setting.

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    David Hoang's questions to Alkermes Plc (ALKS) leadership

    David Hoang's questions to Alkermes Plc (ALKS) leadership • Q2 2025

    Question

    David Hoang from Deutsche Bank inquired about the rationale for selecting an 18mg upper dose in the NT2 and IH studies, given a 25mg dose was used in Phase 1b, and asked about the ideal dose to advance into Phase 3.

    Answer

    Craig Hopkinson, EVP, R&D and Chief Medical Officer, explained that the Phase 2 doses were determined using sophisticated modeling that incorporated all available data from the healthy volunteer and Phase 1b studies.

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    David Hoang's questions to Alkermes Plc (ALKS) leadership • Q1 2025

    Question

    David Hoang inquired about the planned timing for regulatory interactions, such as end-of-Phase II meetings with the FDA, and asked how many doses of ALKS 2680 the company might advance into Phase III studies.

    Answer

    CEO Richard Pops stated that the plan is to bring data from both the NT1 and NT2 studies to a combined end-of-Phase II meeting with the FDA. He also confirmed the intention is to take multiple doses into the Phase III program to leverage the drug's wide therapeutic index, with the final decision being informed by the Phase II results and regulatory feedback.

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    David Hoang's questions to Sarepta Therapeutics Inc (SRPT) leadership

    David Hoang's questions to Sarepta Therapeutics Inc (SRPT) leadership • Q1 2025

    Question

    David Hoang asked if anecdotal experience from commercial ELEVIDYS use matches the EMBARK trial data and how to think about PMO franchise cannibalization given the changing ELEVIDYS uptake curve.

    Answer

    President and CEO Douglas Ingram shared that while anecdotal, the stories from families of commercially treated patients are extraordinary and align with the trial evidence. He did not directly address PMO cannibalization in his response, focusing on the positive real-world feedback for ELEVIDYS.

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    David Hoang's questions to Sarepta Therapeutics Inc (SRPT) leadership • Q4 2024

    Question

    David Hoang of Deutsche Bank asked for Sarepta's thoughts on a competitor's recent DMD gene therapy data and how families might weigh receiving commercial ELEVIDYS versus enrolling in a clinical trial for an experimental product.

    Answer

    CEO Douglas Ingram stated that while they are thrilled to see more research in Duchenne, ELEVIDYS is the only approved, transformative, disease-modifying gene therapy available. Dr. Louise Rodino-Klapac emphasized the importance of the quality and functionality of the dystrophin construct, noting ELEVIDYS's design has been validated in hundreds of patients across multiple studies, which is a critical factor for families and physicians to consider.

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    David Hoang's questions to Sarepta Therapeutics Inc (SRPT) leadership • Q2 2024

    Question

    David Hoang inquired about feedback from treatment centers regarding post-administration patient monitoring and whether this logistical consideration impacts the speed of the launch.

    Answer

    CEO Douglas Ingram confirmed that thoughtful follow-up monitoring is a crucial part of the process and does factor into the number of infusions a center can perform. He emphasized that this is essential for responsible dosing and patient safety. He also noted that based on this monitoring, the company is seeing a very stable safety profile for ELEVIDYS.

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    David Hoang's questions to Axsome Therapeutics Inc (AXSM) leadership

    David Hoang's questions to Axsome Therapeutics Inc (AXSM) leadership • Q1 2025

    Question

    David Hoang of Deutsche Bank requested more color on the expected evolution of payer coverage for Auvelity throughout the year. He also asked for insights into the growth drivers for Sunosi, specifically comparing the narcolepsy and obstructive sleep apnea (OSA) indications.

    Answer

    Ari Maizel, Chief Commercial Officer, stated that the commercial team is focused on increasing covered lives and reducing utilization management for Auvelity, with expectations for access to expand this year. For Sunosi, he noted that while both indications are growing, the larger OSA patient population is experiencing faster growth due to significant unmet need.

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    David Hoang's questions to Axsome Therapeutics Inc (AXSM) leadership • Q4 2024

    Question

    David Hoang inquired about expectations for the seasonal cadence of Auvelity prescriptions in 2025, the potential impact of the sales force expansion, and whether the company would consider providing forward-looking product guidance.

    Answer

    Executive Darren Opland expects Q1 to be a growth quarter for Auvelity, albeit slower than the back half of 2024, with the sales force expansion impact likely visible by late Q1. Chief Financial Officer Nick Pizzie added that the company does not plan to provide sales guidance currently due to market unpredictability but reiterated peak sales estimates of $1B-$3B for Auvelity in MDD.

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