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    Jeff Hung • Morgan Stanley

    Jeff Hung's questions to Insmed Inc (INSM) leadership

    Jeff Hung's questions to Insmed Inc (INSM) leadership • Q4 2024

    Question

    Jeff Hung asked for a definition of the 41,000 bronchiectasis patients who have 'acted' on the company's website and inquired about the expected cadence of these patients seeking prescriptions post-launch.

    Answer

    CEO Will Lewis clarified that 'acting' means patients have visited the disease awareness website, downloaded materials, and registered for more information, providing contact details for future outreach. Regarding timing, he stated there is no direct precedent, but the high motivation observed in both patient registrations and physician surveys (90% intend to prescribe) suggests a strong initial interest at launch.

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    Jeff Hung's questions to Insmed Inc (INSM) leadership • Q3 2024

    Question

    An analyst on for Jeff Hung asked for clarification on the use of the additional $150 million from Pharmakon and inquired about the design of the upcoming TPIP Phase III study in PH-ILD.

    Answer

    CFO Sara Bonstein clarified the $150 million will be received in Q4 and, while not earmarked for a single program, ensures the high-value brensocatib launch is fully resourced. CEO Will Lewis stated that while the final TPIP Phase III design is not yet disclosed, the Phase II study showed compelling directional data on key endpoints like time to clinical worsening, fueling enthusiasm for the program.

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    Jeff Hung's questions to Insmed Inc (INSM) leadership • Q3 2024

    Question

    Lee Hung, on behalf of Jeff Hung at Morgan Stanley, asked for clarification on the use of the additional $150 million from Pharmakon and inquired about the design of the TPIP Phase III study in PH-ILD, including endpoints and the influence of Phase II results.

    Answer

    CFO Sara Bonstein clarified that the additional $150 million from Pharmakon is not earmarked for a specific program but ensures that the brensocatib launch is fully resourced. CEO Will Lewis stated that while the final TPIP Phase III design is not yet disclosed, the Phase II results were encouraging, showing compelling directional data on time to clinical worsening and 6-minute walk distance, which builds enthusiasm for the Phase III program.

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    Jeff Hung's questions to Ultragenyx Pharmaceutical Inc (RARE) leadership

    Jeff Hung's questions to Ultragenyx Pharmaceutical Inc (RARE) leadership • Q4 2024

    Question

    Lee Hung, on behalf of Jeff Hung, asked if the Phase II data for setrusumab would have met the criteria for the Phase III second interim analysis and how baseline fracture rates compared.

    Answer

    CEO Emil Kakkis highlighted the Phase II p-value improvement from 0.04 at 6 months to 0.0014 at 14 months. He stated that the Phase II and Phase III populations are very comparable in terms of entry criteria, age, OI types, and baseline fracture requirements, making the Phase II results a reasonable model for Phase III.

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    Jeff Hung's questions to Neurocrine Biosciences Inc (NBIX) leadership

    Jeff Hung's questions to Neurocrine Biosciences Inc (NBIX) leadership • Q4 2024

    Question

    Jeff Hung asked about the feedback from the FDA at the End-of-Phase-2 meetings for osavampator and NBI-568, specifically questioning if the agency had concerns about the lack of a dose response for NBI-568.

    Answer

    Chief Medical Officer Eiry Roberts stated that the company was very pleased with the outcomes for both meetings, receiving supportive guidance from the agency. Regarding NBI-568, she specified there was 'complete support' for advancing the 20-milligram dose into the Phase 3 program, with alignment on endpoints and the overall registration plan.

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    Jeff Hung's questions to ACADIA Pharmaceuticals Inc (ACAD) leadership

    Jeff Hung's questions to ACADIA Pharmaceuticals Inc (ACAD) leadership • Q3 2024

    Question

    Jeff Hung of Morgan Stanley asked for an update on the ACP-204 program for Alzheimer's disease psychosis, specifically whether regulators have agreed to the master protocol and a reminder of the strategy.

    Answer

    Executive Elizabeth Thompson stated that they have not re-engaged with regulators yet regarding the Phase III portion of the master protocol and plan to do so further into the Phase II study. She noted this may mean the European Phase III startup is slightly slower but sees no overall impact on the strategy or timeline. An advantage could be starting the European Phase III with Phase II data already in hand, which helps with investigator interest.

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    Jeff Hung's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership

    Jeff Hung's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q3 22024

    Question

    Jeff Hung asked if the French real-world data showed a correlation between treatment benefit and time since surgical resection for hypothalamic obesity (HO) patients. He also inquired about the strategic goals of the Axovia partnership for Bardet-Biedl syndrome (BBS) and its potential to improve access to the U.K. patient registry.

    Answer

    Chairman, CEO and President David Meeker stated that time since resection does not appear to impact efficacy, as patients treated over a decade after injury showed benefits consistent with those in the Phase II trial. Regarding Axovia, he and EVP, Head of International Yann Mazabraud explained the partnership supports research into BBS eye findings and epidemiology, noting they already support the U.K. BBS registry.

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