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    Pavan Patel • Bank of America

    Pavan Patel's questions to Amphastar Pharmaceuticals Inc (AMPH) leadership

    Pavan Patel's questions to Amphastar Pharmaceuticals Inc (AMPH) leadership • Q2 2025

    Question

    Pavan Patel, on behalf of Jason Gerberry at Bank of America, asked for guidance on the gross margin trajectory for the second half of the year and clarification on whether the decline in epinephrine PFS sales was due to pricing pressure or market share loss.

    Answer

    CFO Bill Peters explained that margins are expected to contract due to increased price competition for glucagon, absent new product launches. Regarding epinephrine, he stated the sales decline was caused by a combination of both pricing erosion and a drop in unit volume, and that this competition is already reflected in the current quarter's results.

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    Pavan Patel's questions to Amphastar Pharmaceuticals Inc (AMPH) leadership • Q3 2024

    Question

    Pavan Patel asked about the primary driver for lower epinephrine revenue and how the company plans to offset this pressure. He also questioned the reasons for BAQSIMI's year-over-year sales decline, the nature of its competitive headwinds, and the specifics of the planned sales force expansion.

    Answer

    CFO William Peters attributed the epinephrine pressure to increased competition in the multi-dose vial market, which was partly offset by new prefilled syringe sales in Canada. For BAQSIMI, he clarified the year-over-year decline was due to a temporary European supply shortage and lower U.S. net pricing from higher wholesaler fees, not competitive issues. He confirmed a larger, outsourced sales force expansion is planned for January, with some costs occurring in Q4.

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    Pavan Patel's questions to Tarsus Pharmaceuticals Inc (TARS) leadership

    Pavan Patel's questions to Tarsus Pharmaceuticals Inc (TARS) leadership • Q1 2025

    Question

    Pavan Patel inquired about the market reception of new clinical data (Orion, Ersa, Rhea) and requested details on the upcoming Phase II trial design for TP-04 in Ocular Rosacea.

    Answer

    CCO Aziz Mottiwala reported a positive reception to the new data at recent conferences, noting it encourages physicians to diagnose more and consider XDEMVY for broader patient segments like dry eye. COO Seshadri Neervannan explained that the Ocular Rosacea trial will focus on objective measures like prominent blood vessels and erythema, which are key diagnostic features and endpoints aligned with the FDA. CEO Bobak Azamian emphasized the high physician enthusiasm for an Ocular Rosacea treatment.

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    Pavan Patel's questions to Catalyst Pharmaceuticals Inc (CPRX) leadership

    Pavan Patel's questions to Catalyst Pharmaceuticals Inc (CPRX) leadership • Q4 2024

    Question

    Pavan Patel, on for Jason Gerberry, asked about the new indications being pursued for AGAMREE and whether the company's M&A strategy includes gene therapy assets to further revenue diversification.

    Answer

    Chief Medical Officer Dr. Gary Ingenito stated that the company is focused on further characterizing AGAMREE's unique corticosteroid profile to assess its potential in other rare diseases that could benefit from its immunosuppressive qualities. CEO Richard Daly addressed M&A, confirming that Catalyst tracks gene therapy closely. He outlined a cautious approach, stating any potential deal must be close to market, have very clean CMC (Chemistry, Manufacturing, and Controls), and address a clear, unmet need, given the challenging uptake seen with other gene therapies.

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    Pavan Patel's questions to Harmony Biosciences Holdings Inc (HRMY) leadership

    Pavan Patel's questions to Harmony Biosciences Holdings Inc (HRMY) leadership • Q4 2024

    Question

    Pavan Patel, on behalf of Jason Gerberry, asked for specifics on the FDA's concerns in the RTF letter for pitolisant in IH and how that informs the new Pitolisant HD trial. He also asked for evidence supporting that higher doses lead to greater efficacy.

    Answer

    CEO Dr. Jeffrey Dayno stated the RTF was based on the primary endpoint of the INTUNE study not being met, a conservative view that discounted the totality of evidence. He said the focus is now on the Pitolisant HD trial, which will use a parallel-group design. Dr. Kumar Budur added that evidence from all prior pitolisant trials shows a clear dose-response, and a Phase 1b study showed doses up to 180mg were well-tolerated.

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