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    Debjit Chattopadhyay • Guggenheim Securities

    Debjit Chattopadhyay's questions to Krystal Biotech Inc (KRYS) leadership

    Debjit Chattopadhyay's questions to Krystal Biotech Inc (KRYS) leadership • Q2 2025

    Question

    Debjit Chattopadhyay of Guggenheim Partners requested a breakdown of the 82% compliance rate, asked how utilization has evolved between recessive and dominant patients, and inquired about TPS scores for the NSCLC combo trial.

    Answer

    Chairman & CEO Krish Krishnan stated compliance is consistently in the 76-84% range and that variability is driven by moderate-to-mild patients, while recessive patients are more consistent. President of R&D Suma Krishnan said the NSCLC trial is agnostic to TPS scores but will stratify the analysis by PD-L1 expression.

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    Debjit Chattopadhyay's questions to Krystal Biotech Inc (KRYS) leadership • Q1 2025

    Question

    Debjit Chattopadhyay asked for elaboration on the DOJ subpoena, clarification on the compliance rate calculation, and whether to expect lower initial compliance from milder patients in community settings.

    Answer

    Krish Krishnan, Chairman and CEO, stated the company is cooperating with the DOJ but offered no further comment on the subpoena. Jennifer McDonough, SVP of Patient Access, confirmed the compliance calculation includes any missed doses. Krish Krishnan explained that initial compliance is high for all patients, but milder patients may pause sooner and for longer periods after their wounds heal, which is a key differentiator from more severe patients over time.

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    Debjit Chattopadhyay's questions to Krystal Biotech Inc (KRYS) leadership • Q3 2024

    Question

    Debjit Chattopadhyay asked for an outlook on Q4 performance, considering the impact of patients nearing reimbursement caps and holiday seasonality. He also questioned why the company would not provide 2025 guidance for the U.S. market specifically, given the available trend data.

    Answer

    Chairman and CEO Krish Krishnan clarified that his comments on holiday disruption were meant to manage expectations, not to signal a flattening of growth, and that the company remains on track for its two-year target. Regarding 2025 guidance, he acknowledged the validity of guiding for the U.S. separately and said the company would consider it for the Q4 report, noting it would be supplemented by potential ex-U.S. revenues.

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    Debjit Chattopadhyay's questions to Uniqure NV (QURE) leadership

    Debjit Chattopadhyay's questions to Uniqure NV (QURE) leadership • Q2 2025

    Question

    Debjit Chattopadhyay asked if the FDA requires a minimum clinical benefit threshold for AMT-130 versus the ENROL-HD control and questioned the certainty of the FDA's guidance given recent events in the gene therapy sector.

    Answer

    Chief Medical Officer Walid Abi-Saab confirmed that the FDA has not requested a minimum clinical effect threshold. CEO Matt Kapusta added that uniQure has received "clear and unambiguous feedback" and emphasized their approach is meaningfully different as it relies on long-term clinical outcomes data, not a surrogate biomarker.

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    Debjit Chattopadhyay's questions to Uniqure NV (QURE) leadership • Q1 2025

    Question

    Debjit Chattopadhyay asked about the company's confidence in the 3-year cUHDRS follow-up data, what would be a good outcome, whether the Q3 update will include propensity match scoring, and what a future confirmatory study might entail.

    Answer

    CMO Dr. Walid Abi-Saab conveyed high confidence that the dose-dependent slowing of disease progression seen at 2 years will be maintained at 3 years. He stated the Q3 update will share top-line results based on the FDA-agreed statistical plan. Regarding a confirmatory study, he explained the FDA is not ready to discuss specifics until after the BLA review, but it is not expected to delay the accelerated approval filing.

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    Debjit Chattopadhyay's questions to Soleno Therapeutics Inc (SLNO) leadership

    Debjit Chattopadhyay's questions to Soleno Therapeutics Inc (SLNO) leadership • Q1 2025

    Question

    Debjit Chattopadhyay asked what percentage of former Phase III trial patients are reflected in the current start forms and questioned the duration of the free drug program before patients transition to reimbursed therapy.

    Answer

    CCO Meredith Manning confirmed that the majority of the 60 U.S. patients from the pivotal study have submitted start forms. She explained that a bridge program exists for these patients and a 'quick start' program can provide a 28-day supply if reimbursement is delayed, noting payer policies can take six months or more to finalize.

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    Debjit Chattopadhyay's questions to Sarepta Therapeutics Inc (SRPT) leadership

    Debjit Chattopadhyay's questions to Sarepta Therapeutics Inc (SRPT) leadership • Q1 2025

    Question

    Debjit Chattopadhyay asked if the FDA's OTP has a specific protein expression threshold for the LGMD program and requested quantification of the number of non-ambulant boys treated with commercial ELEVIDYS.

    Answer

    President and CEO Douglas Ingram stated they are not providing a specific breakdown of commercial non-ambulant patients treated. Head of R&D Dr. Louise Rodino-Klapac noted that based on preclinical data and prior trial results of around 50% expression, they anticipate the EMERGENE results will be well above any threshold of relevance for functional benefit. Executive Ian Estepan added that start forms are roughly 40% non-ambulatory.

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    Debjit Chattopadhyay's questions to Ionis Pharmaceuticals Inc (IONS) leadership

    Debjit Chattopadhyay's questions to Ionis Pharmaceuticals Inc (IONS) leadership • Q1 2025

    Question

    Debjit Chattopadhyay questioned the team's confidence in the estimated 3,000-patient FCS market and asked how quickly these patients could be converted before potential price erosion from the future sHTG launch.

    Answer

    Chief Commercial Officer Jonathan Birchall expressed confidence in the FCS patient estimate, noting that awareness and identification efforts are accelerating uptake. Chief Global Product Strategy Officer Kyle Jenne explained that TRYNGOLZA was priced for the rare FCS indication. The sHTG indication, with a much larger population, will have a separate pricing strategy determined after data readout. CEO Brett Monia added that Ionis expects to commercialize for FCS for 1.5 to 2 years before the sHTG launch.

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    Debjit Chattopadhyay's questions to Beam Therapeutics Inc (BEAM) leadership

    Debjit Chattopadhyay's questions to Beam Therapeutics Inc (BEAM) leadership • Q3 2024

    Question

    An analyst on behalf of Debjit Chattopadhyay at Guggenheim Securities asked about the expected clinical translation of the NHP ESCAPE data to humans and whether the BEAM-101 data increases confidence in ESCAPE.

    Answer

    President Dr. Giuseppe Ciaramella stated that they expect equivalent or potentially better performance in humans compared to the NHP data, citing the cross-reactivity of the guide RNA and antibody. He affirmed that the strong NHP results provide 'tremendous confidence' for advancing the program into human clinical studies.

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    Debjit Chattopadhyay's questions to Beam Therapeutics Inc (BEAM) leadership • Q3 2024

    Question

    An analyst on behalf of Debjit Chattopadhyay of Guggenheim Securities asked about the human translational expectations from the NHP ESCAPE data and whether the BEAM-101 clinical data bolsters confidence in ESCAPE's potential.

    Answer

    President Dr. Giuseppe Ciaramella stated they expect 'equivalent, if not better performance in human' from ESCAPE. He cited the cross-reactive nature of the antibody and the guide RNA sequence as reasons for high confidence in translation from NHP to human studies, affirming the NHP data provides 'tremendous confidence' for clinical advancement.

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    Debjit Chattopadhyay's questions to Vertex Pharmaceuticals Inc (VRTX) leadership

    Debjit Chattopadhyay's questions to Vertex Pharmaceuticals Inc (VRTX) leadership • Q3 2024

    Question

    Debjit Chattopadhyay of Guggenheim Partners asked about the inaxaplin program, seeking guidance on enrollment completion timing and the potential market size, considering historically low compliance rates for existing renal therapies.

    Answer

    CEO Dr. Reshma Kewalramani did not provide guidance on enrollment completion. COO Stuart Arbuckle sized the market at approximately 100,000 patients in the U.S. and Europe, acknowledging that many are undiagnosed. He framed inaxaplin as a multi-billion dollar opportunity that will require significant investment in disease awareness and genotyping.

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