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    Matthew Kaplan • Ladenburg Thalmann & Co. Inc.

    Matthew Kaplan's questions to Liquidia Corp (LQDA) leadership

    Matthew Kaplan's questions to Liquidia Corp (LQDA) leadership • Q3 2024

    Question

    Matthew Kaplan of Ladenburg Thalmann inquired about the company's launch preparations for YUTREPIA, focusing on the size and structure of the commercial sales force.

    Answer

    Chief Commercial Officer Scott Moomaw detailed that an experienced sales team, primarily from the PH space, has been in place for approximately a year. The force is sized to cover 6,000-7,000 targets, including large PH centers and community pulmonologists treating ILD. A specialized team of key account directors will also provide deep coverage for the most significant academic medical centers.

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    Matthew Kaplan's questions to Liquidia Corp (LQDA) leadership • Q2 2024

    Question

    Matthew Kaplan of Ladenburg Thalmann & Co. Inc. asked if the FDA has identified any material issues that could prevent YUTREPIA's approval and lead to a Complete Response Letter (CRL), given that legal impediments have passed.

    Answer

    CEO Dr. Roger Jeffs declined to comment on specific FDA discussions but framed the four months since the legal stay was lifted as a positive period of constructive dialogue. He emphasized that the company remains optimistic and is still actively seeking approval for both PAH and PH-ILD indications as submitted in the amended NDA, without backing away from that position.

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    Matthew Kaplan's questions to Axsome Therapeutics Inc (AXSM) leadership

    Matthew Kaplan's questions to Axsome Therapeutics Inc (AXSM) leadership • Q3 2024

    Question

    Matthew Kaplan of Ladenburg Thalmann asked about the company's current thinking on the launch plan for AXS-05 in ADA, specifically whether it would be filed as a line extension for Auvelity or as a new brand.

    Answer

    CEO Herriot Tabuteau responded that the company has the flexibility to file AXS-05 as either a supplemental NDA (sNDA) for Auvelity or a freestanding New Drug Application (NDA). He noted that the final approach is still being evaluated and will be a 'very well thought-out decision.'

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    Matthew Kaplan's questions to Urogen Pharma Ltd (URGN) leadership

    Matthew Kaplan's questions to Urogen Pharma Ltd (URGN) leadership • Q3 2024

    Question

    Matthew Kaplan questioned if the FDA's call for an ODAC was due to controversy over the single-arm ENVISION trial design and also inquired about the company's cash runway through the UGN-102 launch.

    Answer

    CMO Dr. Mark Schoenberg clarified that the FDA had agreed in writing that the single-arm trial could support approval and believes the ODAC is for a public vetting of a paradigm-changing therapy, not due to controversy. CFO Chris Degnan affirmed that the company's $254 million cash position is sufficient to reach profitability based on current plans.

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    Matthew Kaplan's questions to TG Therapeutics Inc (TGTX) leadership

    Matthew Kaplan's questions to TG Therapeutics Inc (TGTX) leadership • Q3 2024

    Question

    Matthew Kaplan of Ladenburg Thalmann asked for details on patient persistence rates for BRIUMVI compared to competitors and inquired about the timeline for completing studies to get the faster infusion data from the ENHANCE trial into the product's label.

    Answer

    Chief Commercialization Officer Adam Waldman stated that based on competitor published data, BRIUMVI's week 24 compliance appears to be at least as good, if not better. CEO Michael Weiss estimated that getting the faster infusion into the label is likely a 2-to-3-year process, involving a randomized trial that would start next year and take about a year to enroll.

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    Matthew Kaplan's questions to Ardelyx Inc (ARDX) leadership

    Matthew Kaplan's questions to Ardelyx Inc (ARDX) leadership • Q3 2024

    Question

    Matthew Kaplan asked for an update on progress with the Kidney Care Act, specific court timelines for the APA lawsuit injunction, and feedback from the recent ASN meeting regarding how physicians are utilizing XPHOZAH.

    Answer

    President and CEO, Mike Raab, highlighted the growing support for the Kidney Care Act, with 38 House and 2 Senate co-sponsors, and noted the court must decide on the injunction by year-end. Chief Commercial Officer, Eric Foster, added that feedback from ASN was strong, with physicians using XPHOZAH on-label with binders and seeing significant results in patients.

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    Matthew Kaplan's questions to Corcept Therapeutics Inc (CORT) leadership

    Matthew Kaplan's questions to Corcept Therapeutics Inc (CORT) leadership • Q3 2024

    Question

    Matthew Kaplan of Ladenburg Thalmann asked if the initial CATALYST study results, which showed high hypercortisolism prevalence, were driving increased screening and Korlym prescriptions.

    Answer

    Sean Maduck, President of the Endocrinology division, confirmed that the CATALYST results are beginning to have an impact, though the full effect on clinical practice will take time and is expected in 2025 and beyond. He noted that increased physician awareness of hypercortisolism's prevalence is already driving volume growth for Korlym, and the superior profile of relacorilant is expected to accelerate this, positioning the company for a potential $3 billion business in five years.

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