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    Andrew Tsai • Jefferies

    Andrew Tsai's questions to Stoke Therapeutics Inc (STOK) leadership

    Andrew Tsai's questions to Stoke Therapeutics Inc (STOK) leadership • Q2 2025

    Question

    Andrew Tsai from Jefferies requested details on the data used to inform the Phase 3 EMPORER study's design, particularly the powering assumptions for the Vineland endpoint, and asked what would constitute a statistically significant result.

    Answer

    CMO Barry Ticho explained that powering was based on data from a patient group with a dosing regimen similar to Phase 3, which showed substantial Vineland score improvements versus a natural history cohort. The study was powered conservatively, assuming a 20% placebo effect. He stated that statistical significance is based on a clinically meaningful change of 1-3 raw score points, though the company anticipates potentially greater changes based on existing data.

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    Andrew Tsai's questions to Xenon Pharmaceuticals Inc (XENE) leadership

    Andrew Tsai's questions to Xenon Pharmaceuticals Inc (XENE) leadership • Q2 2025

    Question

    Andrew Tsai from Jefferies asked about the bipolar depression study, focusing on the potential timing of its built-in interim analysis, the efficacy threshold required at that point, and whether the study is intended to be a pivotal trial.

    Answer

    President and CEO Ian Mortimer confirmed the program is designed to be registrational. Chief Medical Officer Christopher Kenney explained that the interim analysis timing depends on recruitment and is designed to assess if the study's power is sufficient at 400 patients or if an increase up to 470 patients is needed. This flexibility was included due to the lack of prior clinical data for Ezetucalner in this specific indication.

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    Andrew Tsai's questions to Xenon Pharmaceuticals Inc (XENE) leadership • Q1 2025

    Question

    Andrew Tsai asked if Xenon would announce the completion of X-TOLE2 enrollment or simply narrow the data timing guidance. He also inquired about the baseline characteristics of enrolled X-TOLE2 patients, specifically the number of prior anti-epileptic drugs (AEDs), compared to the Phase II study.

    Answer

    President and CEO Ian Mortimer responded that the company will refine and narrow its data timing guidance as enrollment nears completion. Regarding patient characteristics, he did not provide specific numbers but stated that the overall patient population in Phase III is demonstrating 'consistency with the X-TOLE study,' suggesting a similar profile in terms of prior AEDs and other demographics.

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    Andrew Tsai's questions to Iovance Biotherapeutics Inc (IOVA) leadership

    Andrew Tsai's questions to Iovance Biotherapeutics Inc (IOVA) leadership • Q2 2025

    Question

    Andrew Tsai of Jefferies questioned if the net cash burn guidance of less than $245 million for the next year implies a significant improvement in gross margins starting as early as Q3, and sought color on the drivers for this potential improvement.

    Answer

    Interim CEO Frederick Vogt confirmed the net cash burn guidance and affirmed that improving gross margins is a key objective of the recent strategic restructuring. He stated that margins are expected to increase through operational excellence initiatives, reduced cost of sales, and higher manufacturing capacity utilization at the company's internal facility as revenue volume grows.

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    Andrew Tsai's questions to Iovance Biotherapeutics Inc (IOVA) leadership • Q4 2024

    Question

    Andrew Tsai asked to identify the primary bottleneck for accelerating the commercial launch uptake, if it is not patient demand, manufacturing supply, or hospital bed availability.

    Answer

    Interim CEO Frederick Vogt identified the main factor as the time required for newer ATCs to gain operational proficiency, with each center having its own minor, resolvable bottlenecks. CCO Dan Kirby added that there is a natural learning curve for a first-in-class therapy, and the key growth lever is now driving community referrals to the increasingly experienced centers.

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    Andrew Tsai's questions to Avadel Pharmaceuticals PLC (AVDL) leadership

    Andrew Tsai's questions to Avadel Pharmaceuticals PLC (AVDL) leadership • Q2 2025

    Question

    Andrew Tsai of Jefferies questioned the implied moderation in Q3/Q4 growth following the full-year guidance raise, asking about conservatism and seasonality. He also sought data on new patient initiations in Q2 to assess dropout rates and future persistency trends.

    Answer

    CEO Gregory Divis stated the guidance assumes continued growth and sustained improvements in patient metrics like persistency and reimbursement rates. CFO Tom McHugh noted the Q1 to Q2 lift is partly due to gross-to-net improvements. Regarding persistency, Divis confirmed that positive trends from Q1 continued into Q2 and are expected to be durable, driven by execution rather than patient mix.

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    Andrew Tsai's questions to Avadel Pharmaceuticals PLC (AVDL) leadership • Q4 2024

    Question

    John, on behalf of Andrew Tsai from Jefferies, requested additional details on Q1 patient trends and guidance on how to model gross-to-net adjustments and inventory levels for the first quarter.

    Answer

    Executive Gregory Divis stated that key patient demand metrics, including enrollments and patient starts, were tracking at or above internal expectations for Q1, with the revenue impact expected to become more apparent in Q2. Executive Thomas McHugh explained that gross-to-net is seasonally highest in Q1 due to insurance deductible resets and confirmed that inventory levels in the channel have remained consistent with the end of 2024.

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    Andrew Tsai's questions to Arcutis Biotherapeutics Inc (ARQT) leadership

    Andrew Tsai's questions to Arcutis Biotherapeutics Inc (ARQT) leadership • Q2 2025

    Question

    Andrew Tsai of Jefferies asked for the company's latest perspective on the peak sales opportunity for Zareve's three current indications and whether that view has evolved. He also inquired about a potential timeline for initial data from the investigator-sponsored studies in vitiligo and HS.

    Answer

    President and CEO Frank Watanabe reiterated previous guidance, suggesting each of the three main indications could represent a $700 million to $1.2 billion opportunity, and stated that achieving 10% of the total topical market is a very achievable goal. He noted that the company is just scratching the surface of the commercial opportunity. Regarding the clinical trials, he stated that no specific timeline for data from the collaborative vitiligo and HS studies is being provided at this time.

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    Andrew Tsai's questions to BridgeBio Pharma Inc (BBIO) leadership

    Andrew Tsai's questions to BridgeBio Pharma Inc (BBIO) leadership • Q2 2025

    Question

    Andrew Tsai of Jefferies asked how BridgeBio operationally leverages new data to drive adoption, requested a summary of planned data generation for Atruvio over the next 1-2 years, and asked for quantification of inventory changes in Q2.

    Answer

    CEO Neil Kumar explained the strategy involves publications, medical affairs engagement, and real-world evidence studies to increase scientific share of voice, with a future focus on rapidity of response. CCO Matthew Outten addressed inventory, stating that days of inventory on hand declined from Q1 to Q2 as distributors grew confident in the company's 'just-in-time' supply model, which reduces their need to hold large stock.

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    Andrew Tsai's questions to Vanda Pharmaceuticals Inc (VNDA) leadership

    Andrew Tsai's questions to Vanda Pharmaceuticals Inc (VNDA) leadership • Q2 2025

    Question

    Andrew Tsai of Jefferies questioned the rationale for filing Bisanti under a 505(b)(1) NDA instead of a 505(b)(2), the efficacy target for the Phase 3 MDD trial to be considered compelling, and the status and expected sales impact of the direct-to-consumer (DTC) campaigns for Fanapt and Ponvory.

    Answer

    President, CEO & Chairman Mihael Polymeropoulos clarified that the 505(b)(1) pathway for Bisanti was chosen at the FDA's direction because it is a new chemical entity, with bioequivalence serving as the required clinical evidence. For the MDD trial, he explained that the primary endpoint is statistical superiority over placebo, and the drug's competitiveness will be judged on its overall profile and tolerability rather than a specific efficacy delta. He also confirmed the DTC campaigns are ongoing, and their effectiveness is continuously being evaluated before any adjustments are made.

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    Andrew Tsai's questions to Vanda Pharmaceuticals Inc (VNDA) leadership • Q4 2024

    Question

    Andrew Tsai of Jefferies questioned the rationale for issuing 2030 revenue guidance, the breakdown of approved versus unapproved products in that forecast, the expected timing of the company's revenue and cash trough, and the sales contribution from HETLIOZ indications not facing generic competition.

    Answer

    Executive Kevin Moran explained the 2030 guidance reflects confidence driven by current commercial investments and a robust pipeline, noting the $750 million psychiatry target includes future approvals for Bysanti and Fanapt LAI. Moran asserted that the revenue trough year is "over the shoulder," citing 2024 growth and the 2025 forecast. However, he declined to provide a specific sales breakdown for HETLIOZ by indication or geography.

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    Andrew Tsai's questions to Sarepta Therapeutics Inc (SRPT) leadership

    Andrew Tsai's questions to Sarepta Therapeutics Inc (SRPT) leadership • Q1 2025

    Question

    Andrew Tsai asked about the potential worst-case scenario of ELEVIDYS being pulled from the market following the patient death, particularly in light of a recent FDA leadership appointment.

    Answer

    President and CEO Douglas Ingram expressed confidence that the FDA will remain a science-driven organization. He emphasized that the evidence for ELEVIDYS's approval was remarkable and has only grown stronger with new data. He stated there is no reason to believe the tragic but unique safety event, in the context of over 800 patients dosed and a laudable safety profile for an AAV gene therapy, would motivate such a drastic action.

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    Andrew Tsai's questions to Supernus Pharmaceuticals Inc (SUPN) leadership

    Andrew Tsai's questions to Supernus Pharmaceuticals Inc (SUPN) leadership • Q4 2024

    Question

    Andrew Tsai asked for confirmation on an inferred 2025 revenue range for Qelbree, inquired about the key growth levers for the drug, and questioned how the company's business development appetite and M&A firepower have changed following the SPN-820 trial data.

    Answer

    CEO Jack Khattar confirmed the inferred Qelbree revenue range is fair and identified continued prescription growth as the primary lever, citing high patient satisfaction and market outperformance. He stated that business development remains a top priority, focusing on revenue-generating products and late-stage assets, and noted the company has significant financial flexibility for deals ranging from $500 million to $1.5 billion, depending on the target's cash flow.

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