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    Luke Herrmann • Robert W. Baird & Co.

    Luke Herrmann's questions to PTC Therapeutics Inc (PTCT) leadership

    Luke Herrmann's questions to PTC Therapeutics Inc (PTCT) leadership • Q2 2025

    Question

    Luke Herrmann from Baird asked for two regulatory clarifications: Has the FDA provided any indication on when labeling discussions for vutiquinone might begin? And has the agency given a timeline for an action date for the Translarna U.S. review?

    Answer

    CEO Dr. Matthew Klein responded that for vutiquinone, no formal timetable for labeling discussions or next steps was given during the recent late-cycle meeting. For Translarna, he clarified that due to the specific regulatory history of the application (a resubmission after a Refuse to File), it is not part of the PDUFA program, and therefore a PDUFA action date will not be issued.

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    Luke Herrmann's questions to Catalyst Pharmaceuticals Inc (CPRX) leadership

    Luke Herrmann's questions to Catalyst Pharmaceuticals Inc (CPRX) leadership • Q2 2025

    Question

    Luke Herrmann asked whether all issues from the Change Healthcare disruption are fully resolved and inquired about any recent evolution in the company's manufacturing strategy for Firdapse and Agamry, particularly in light of potential pharma tariffs.

    Answer

    President & CEO Richard Daly confirmed that the Change Healthcare disruption's effects have fully washed through the system and Firdapse's sales cadence has returned to normal. Regarding manufacturing, he stated that Firdapse is well-protected with its US and Canadian manufacturing, and the company is already in the process of transitioning Agamry manufacturing to the U.S., which will shield it from potential tariffs in the mid- to long-term.

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    Luke Herrmann's questions to Mirum Pharmaceuticals Inc (MIRM) leadership

    Luke Herrmann's questions to Mirum Pharmaceuticals Inc (MIRM) leadership • Q2 2025

    Question

    Luke Herrmann from Baird, on behalf of Brian Skorney, asked about any inventory impacts on LIVMARLI sales in Q2 and sought more clarity on the ordering cadence from partner Takeda in Japan.

    Answer

    COO & President Peter Radovich clarified that inventory is only relevant for the Takeda partnership, with no significant channel inventory in the U.S. or Europe. He described Takeda orders as large and periodic, causing variability. Co-Founder & CEO Chris Peetz specified that $11 million of Q2 revenue was from a Takeda order.

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    Luke Herrmann's questions to Mirum Pharmaceuticals Inc (MIRM) leadership • Q1 2025

    Question

    On behalf of Brian Skorney, Luke Herrmann requested insight into the rate of patient identification for CTEXLI since its approval and the company's forward-looking expectations for this process.

    Answer

    President and Chief Operating Officer Peter Radovich reported a 'nice uptick' in CTX patient identification since the February approval. He attributed the progress to promotional efforts, the credibility of an FDA-approved label, and targeted disease awareness campaigns in specialties like neurology and ophthalmology to increase diagnostic suspicion.

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    Luke Herrmann's questions to Mirum Pharmaceuticals Inc (MIRM) leadership • Q4 2024

    Question

    Luke Herrmann, on for Brian Skorney, asked how the VANTAGE study accounts for prior Ocaliva (OCA) use and if discontinuing OCA could affect pruritus measurements.

    Answer

    CMO Joanne Quan explained that prior OCA use has not been a significant factor in enrollment, reflecting general usage patterns. CEO Chris Peetz added that approximately two-thirds of VANTAGE patients are first-line, meaning they would not have previously used second-line treatments like OCA.

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    Luke Herrmann's questions to Alkermes Plc (ALKS) leadership

    Luke Herrmann's questions to Alkermes Plc (ALKS) leadership • Q2 2025

    Question

    Luke Herrmann of Baird asked about the drivers of the strong revenue growth, specifically the relative contribution from inventory changes or seasonal dynamics versus underlying demand for the commercial portfolio.

    Answer

    Blair Jackson, Executive VP & COO, confirmed that demand increased across all three proprietary products and that there were no inventory dynamics contributing to the quarter's results. Todd Nichols, Chief Commercial Officer, added that the team was pleased with a strong step-up in new patient starts and that inventory levels are growing in line with demand.

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