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    Kambiz Yazdi • Jefferies

    Kambiz Yazdi's questions to Liquidia Corp (LQDA) leadership

    Kambiz Yazdi's questions to Liquidia Corp (LQDA) leadership • Q1 2025

    Question

    Kambiz Yazdi from Jefferies inquired about the target patient characteristics for the upcoming YUTREPIA transition study and requested a status update on the L606 program.

    Answer

    Chief Medical Officer Dr. Rajeev Saggar responded, stating the transition study will enroll PH-ILD patients currently on TYVASO (nebulized or DPI) to demonstrate a safe transition and potential for improved titration and clinical stability. Regarding L606, he confirmed it is a global study with over 300 patients that is expected to be initiated by the end of the year.

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    Kambiz Yazdi's questions to Liquidia Corp (LQDA) leadership • Q3 2024

    Question

    Kambiz Yazdi from Jefferies asked for details on the L606 open-label study, including how many patients achieved a dose over 100-micrograms twice daily and if adverse events were consistent with previous studies. He also inquired about the supply chain robustness for the YUTREPIA DPI inhaler.

    Answer

    Chief Medical Officer Dr. Rajeev Saggar reported that the 'overwhelming majority' of patients exceeded the 100mcg twice-daily dose, with the median dose surpassing 200mcg, underscoring the drug's tolerability. CEO Dr. Roger Jeffs added that L606 achieves 2-3 times the therapeutic target of nebulized TYVASO. CFO Michael Kaseta confirmed that the company has been manufacturing commercial supply since early 2022 and is 'ultra-prepared' with sufficient inventory for the YUTREPIA launch.

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    Kambiz Yazdi's questions to Liquidia Corp (LQDA) leadership • Q2 2024

    Question

    Kambiz Yazdi of Jefferies LLC requested details on the registrational study design for L606 and its start date, and also asked for an update on the number of sites and patients in the ASCENT study.

    Answer

    Chief Medical Officer Dr. Rajeev Saggar stated that the global, placebo-controlled L606 study in PH-ILD patients is planned to start by the end of the year, with 6-minute walk distance as the primary endpoint. For the ASCENT trial, he reported that the number of sites is close to tripling, with about 15 patients expected by the end of the month, and the company is confident in completing the study by year-end.

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    Kambiz Yazdi's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership

    Kambiz Yazdi's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership • Q1 2025

    Question

    Kambiz Yazdi of Jefferies asked for guidance on modeling R&D expenses going forward and for perspective on how biosimilars are shaping the wet AMD market, including whether a post-marketing study with a biosimilar could be considered.

    Answer

    CFO George Elston explained that while Q1 R&D was higher due to rapid enrollment, the full-year model is likely still correct, with some spend shifted earlier. CEO Dr. Jay Duker stated the company is agnostic to which anti-VEGF is used for loading doses, including biosimilars, as they don't expect a difference in outcomes. He emphasized that DURAVYU's different mechanism and 6-month duration differentiate it from the biosimilar market.

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    Kambiz Yazdi's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership • Q4 2024

    Question

    Kambiz Yazdi asked about EyePoint's long-term plans for post-marketing studies for DURAVYU and what information from such studies could help further differentiate the product in the wet AMD market.

    Answer

    President and CEO Dr. Jay Duker explained that a key post-approval study would be a head-to-head trial against a market leader like VABYSMO, with a primary endpoint of supplement-free rate. Chief Medical Officer Ramiro Ribeiro added that they could also explore additional benefits, such as the prevention of atrophy.

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    Kambiz Yazdi's questions to Arcutis Biotherapeutics Inc (ARQT) leadership

    Kambiz Yazdi's questions to Arcutis Biotherapeutics Inc (ARQT) leadership • Q1 2025

    Question

    Kambiz Yazdi from Jefferies asked about the next steps following the stay in the Padagis patent litigation, the key learnings from ARQ-252 that informed the ARQ-255 formulation, and the potential market white space for a new topical treatment in alopecia areata.

    Answer

    CEO Frank Watanabe explained the litigation stay is indefinite and was requested by Padagis, suggesting a potential issue with their ANDA filing. He stated Arcutis remains confident in its IP. Patrick Burnett, Chief Medical Officer, clarified that ARQ-255 is a completely new suspension formulation designed to deliver the drug deep into the hair follicle, overcoming the delivery challenges of ARQ-252. He identified the white space for a topical in alopecia areata as treating patients with less than 50% scalp involvement and as a long-term management option for those who have responded to systemic JAK inhibitors.

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    Kambiz Yazdi's questions to Arcutis Biotherapeutics Inc (ARQT) leadership • Q4 2024

    Question

    Kambiz Yazdi from Jefferies asked what proportion of Q4 sales were attributable to the Kowa PCP partnership and inquired about the Q1 OpEx outlook, including how commissions to Kowa would be accounted for.

    Answer

    Chief Financial Officer David Topper clarified that the contribution from the Kowa partnership in Q4 2024 was not significant, as their efforts began late in the year, but a meaningful contribution is expected in 2025. He confirmed that commissions paid to Kowa will be included in the SG&A line item and will be detailed in future reports once the contribution becomes material.

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    Kambiz Yazdi's questions to Arcutis Biotherapeutics Inc (ARQT) leadership • Q3 2024

    Question

    Kambiz Yazdi of Jefferies asked about the proportion of Q3 sales attributable to the Kowa deal, the terms of the Kowa agreement, the blend of commercial versus government payer contribution to Q3 revenue, and how the company's pricing strategy has aided payer negotiations.

    Answer

    CFO David Topper stated the Kowa contribution in Q3 was immaterial as the partnership began in mid-September. CEO Frank Watanabe confirmed the Kowa agreement is for five years and positions ZORYVE as a priority product. CCO Todd Edwards noted Q3 revenue was driven primarily by commercial payers. Frank Watanabe explained the pricing strategy was designed to avoid the Medicare specialty tier, which has been validated by rapid commercial and Medicaid coverage wins.

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    Kambiz Yazdi's questions to Praxis Precision Medicines Inc (PRAX) leadership

    Kambiz Yazdi's questions to Praxis Precision Medicines Inc (PRAX) leadership • Q3 2024

    Question

    Kambiz Yazdi inquired about the measures taken to control for placebo response in the decentralized Essential3 study and asked about the historical performance of sodium channel blockers in PGTC seizures and the potential design of a registrational program for Vormatrigine.

    Answer

    CEO Marcio Souza explained that to control placebo response, they added measures to monitor patient stability at baseline. He noted that while historical results for sodium channel blockers in generalized epilepsy are mixed, Vormatrigine's selectivity is a key differentiator. The ongoing RADIANT study will inform the design of a future registrational study for this indication.

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    Kambiz Yazdi's questions to Praxis Precision Medicines Inc (PRAX) leadership • Q2 2024

    Question

    Kambiz Yazdi asked how patient enrollment would be prioritized between the POWER1 and RADIANT studies and requested details on the elsunersen program, including regulatory feedback for its initiation in Brazil and requirements for advancement in the U.S. and Europe.

    Answer

    CEO Marcio Souza clarified that the POWER1 and RADIANT studies are not competitive for enrollment, as RADIANT is a smaller study that can start more quickly. For elsunersen, he confirmed full feedback was received to start the study in Brazil. He noted that preliminary feedback from Europe is aligned with their plans for a launch later this year, and a similar process is underway with the FDA for the complex program.

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