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    Philip Nadeau • TD Cowen

    Philip Nadeau's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership

    Philip Nadeau's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q2 2025

    Question

    Philip Nadeau of TD Cowen sought more detail on what constitutes 'good data' for the Prader-Willi trial, specifically regarding BMI decrease, hunger reduction, and consistency. He also asked a housekeeping question about the trajectory of stock-based compensation.

    Answer

    David Meeker, Chairman, President & CEO, identified weight loss as the primary endpoint, targeting a BMI decrease of at least 5% at one year, as any weight loss is significant in this population. He noted hyperphagia data will be collected but is harder to interpret in an open-label study. CFO Hunter Smith addressed the second question, stating that the Q2 stock compensation level is a fair baseline moving forward, driven by the stock price increase.

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    Philip Nadeau's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q1 2025

    Question

    Philip Nadeau from TD Cowen asked about the purpose of the upcoming FDA meeting for the HO filing, requested quantification of the Q1 revenue impact from insurance reauthorizations, and inquired about the payer mix for BBS and expectations for HO.

    Answer

    David Meeker, CEO, described the FDA meeting as a standard pre-filing interaction to align on the data presentation. CFO Hunter Smith quantified the insurance reauthorization impact at approximately $700,000. Jennifer Chien, Head of North America, stated the BBS payer mix is roughly an equal split between commercial and Medicaid, totaling about 80%, and that the HO mix is still under evaluation.

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    Philip Nadeau's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q4 2024

    Question

    Philip Nadeau asked for clarification on what management considers 'doing well' for the HO pivotal trial's primary endpoint and questioned if a Q4 inventory build would lead to a destock in Q1.

    Answer

    CEO David Meeker stated that while the regulatory hurdle is 5% weight loss, they would be disappointed with less than 10%, emphasizing the drug's proven efficacy. CFO Hunter Smith confirmed they anticipate a destocking of inventory in Q1 2025, noting the first quarter can often be 'lumpy'.

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    Philip Nadeau's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q3 2024

    Question

    Philip Nadeau inquired about the financial impact of the Q3 revenue pull-forward from Q4 and asked about the criteria and timeline for advancing a gene population from the DAYBREAK trial into a pivotal study.

    Answer

    Chief Financial Officer Hunter Smith estimated the revenue pull-forward from Q4 into Q3 was approximately $0.5 million. Chairman, CEO and President David Meeker explained that advancing a DAYBREAK gene requires a better understanding of which genetic variants are true loss-of-function. He noted that a gene like PHIP could be advanced with a next-generation program, positioning it as a potential 2026 activity.

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    Philip Nadeau's questions to Biogen Inc (BIIB) leadership

    Philip Nadeau's questions to Biogen Inc (BIIB) leadership • Q2 2025

    Question

    Philip Nadeau of TD Cowen asked about Biogen's AHEAD-three 45 trial for early Alzheimer's, inquiring about the potential for an interim analysis and the key design differences compared to a competitor's trial.

    Answer

    Priya Singhal, EVP & Head of Development, detailed significant design differences, noting AHEAD-three 45 uses amyloid PET for screening and includes only patients with no cognitive decline (CDR global score of 0). She contrasted this with the competitor's mixed inclusion criteria. Singhal stated the trial readout is planned for 2028 and, while reserving optionality, no interim analysis is currently planned.

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    Philip Nadeau's questions to Biogen Inc (BIIB) leadership • Q2 2025

    Question

    Philip Nadeau of TD Cowen asked about Biogen's AHEAD-345 trial for early Alzheimer's, inquiring about the potential for an interim analysis and the key design differences compared to a competitor's trial.

    Answer

    Priya Singhal, EVP & Head of Development, explained that the AHEAD-345 trial is scientifically distinct, using amyloid PET screening and targeting a truly presymptomatic population with a CDR global score of zero. She contrasted this with a competitor's mixed inclusion criteria. Singhal clarified that the trial has specific biomarker and cognitive endpoints and is planned for a 2028 readout, with no interim analysis currently scheduled.

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    Philip Nadeau's questions to Biogen Inc (BIIB) leadership • Q4 2024

    Question

    Philip Nadeau asked about LEQEMBI's short-term trajectory, questioning the dynamics behind its recognized revenue versus in-market sales growth and whether strong ex-U.S. growth is replicable.

    Answer

    President and CEO Christopher Viehbacher highlighted strong growth in both U.S. and ex-U.S. markets and expects continued steady progress, with future catalysts like subcutaneous formulations and diagnostics taking time to impact the trajectory. CFO Michael McDonnell reiterated the strong sequential growth in global in-market sales (+30%) and U.S. sales (+28%) for the quarter.

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    Philip Nadeau's questions to Biogen Inc (BIIB) leadership • Q3 2024

    Question

    Philip Nadeau asked for an update on the filing status for the subcutaneous (subcu) formulation of LEQEMBI, for both maintenance and induction therapy.

    Answer

    Dr. Priya Singhal, Head of Development, stated that the subcutaneous maintenance filing is expected to be imminent. For the induction indication, she noted that data is being analyzed from the Clarity open-label extension study, with a regulatory outcome anticipated by the first quarter of 2026.

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    Philip Nadeau's questions to Neurocrine Biosciences Inc (NBIX) leadership

    Philip Nadeau's questions to Neurocrine Biosciences Inc (NBIX) leadership • Q2 2025

    Question

    Philip Nadeau of TD Cowen inquired about the strong launch of Crinesity, asking if the impressive Q2 sales number was influenced by a bolus of warehoused patients and whether the growth is sustainable.

    Answer

    CCO Eric Benevich stated that the strong adoption was not due to a patient bolus but rather steady and consistent uptake as patients flow through endocrinology practices. He noted that the ENDO conference helped accelerate awareness. Strategic Advisor Eiry Roberts added that patients from the clinical trial program are also transitioning steadily to commercial product, not in a single bolus.

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    Philip Nadeau's questions to Neurocrine Biosciences Inc (NBIX) leadership • Q1 2025

    Question

    Philip Nadeau asked about the expected magnitude of INGREZZA's sequential sales growth from Q1 to Q2 2025 and requested details on the time it takes from a CRENESSITY prescription to the patient receiving the drug.

    Answer

    Chief Financial Officer Matthew Abernethy projected a 'nice step up' for INGREZZA sales in Q2, driven by an additional order week and new patient momentum, though this will be partially offset by a slight sequential increase in gross-to-net deductions from new contracts. He noted it was too early to provide a specific time-to-fill metric for CRENESSITY but described the typical process as taking 5-7 days.

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    Philip Nadeau's questions to Neurocrine Biosciences Inc (NBIX) leadership • Q4 2024

    Question

    Philip Nadeau inquired about Neurocrine's expectations for the trajectory of new patient start forms for CRENESSITY and what the company would consider a successful ramp.

    Answer

    Chief Commercial Officer Eric Benevich and Chief Financial Officer Matthew Abernethy responded that while they would not provide specific guidance on the pace of new start forms, they were very pleased with the early launch dynamics, including 11 forms received in just a few working days at the end of 2024. They emphasized that as the first new medicine for CAH in over 70 years, the adoption curve will be measured, but they are confident in its long-term potential, citing strong initial receptivity.

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    Philip Nadeau's questions to Vir Biotechnology Inc (VIR) leadership

    Philip Nadeau's questions to Vir Biotechnology Inc (VIR) leadership • Q1 2025

    Question

    Philip Nadeau asked two questions: first, whether the multiple new dose levels tested for VIR-5500 since January have continued to show a dose response. Second, he asked for clarification on whether the new HDV prevalence figures represent overall or diagnosed patients and what the diagnosis rate is.

    Answer

    Mika Derynck (Executive) declined to comment on the ongoing VIR-5500 dose escalation but noted encouragement from the dose response observed in the VIR-5818 program. Marianne De Backer (Executive) clarified that the HDV figures are for RNA-positive, actively viremic patients eligible for treatment, not just diagnosed patients, and detailed the methodology used to arrive at the 61,000 U.S. patient estimate.

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    Philip Nadeau's questions to Vir Biotechnology Inc (VIR) leadership • Q4 2024

    Question

    Philip Nadeau of TD Cowen asked for the basis of management's confidence that higher doses of VIR-5500 will lead to better PSA responses, given the lack of a clear dose response in initial data. He also asked about the expected quality and quantity of data for the next updates on VIR-5500 and VIR-5818.

    Answer

    CEO Dr. Marianne De Backer stated the company will share meaningful updates as data on safety, efficacy, and durability develops from ongoing dose escalations. Dr. Mark Eisner, CMO, emphasized that the PSMA program is still very early in dose escalation with significant room to increase the dose. He cited a colorectal cancer patient in the HER2 program who saw deepening responses with dose escalation as an example of the platform's potential, expressing anticipation for similar results in the PSMA program.

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    Philip Nadeau's questions to Vir Biotechnology Inc (VIR) leadership • Q3 2024

    Question

    Philip Nadeau asked if Vir will disclose the final HDV trial design and timelines at the upcoming analyst meeting. He also questioned whether the T-cell engagers need to demonstrate clear differentiation in Phase I or if being safe and effective is sufficient to advance them.

    Answer

    Dr. Mark Eisner, Chief Medical Officer, responded that more information on the final HDV trial design will be shared at the investor event, but timelines may not be fully clarified at that point. Regarding the T-cell engagers, he explained that advancement will be a data-driven decision focused on proof of concept from the initial monotherapy data expected in Q1.

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    Philip Nadeau's questions to Dynavax Technologies Corp (DVAX) leadership

    Philip Nadeau's questions to Dynavax Technologies Corp (DVAX) leadership • Q1 2025

    Question

    Philip Nadeau asked about the drivers behind the lower-than-usual seasonality for HEPLISAV-B in Q1 and whether this represents a new trend. He also sought clarity on the upcoming shingles vaccine data, questioning if the Q3 readout would be sufficient for a go/no-go decision. Lastly, he inquired about the company's interactions with the FDA amidst leadership changes in Washington.

    Answer

    CCO Donn Casale attributed the strong Q1 performance and flattened seasonality to a purposeful focus by major retailers on non-flu vaccines, including Hepatitis B. CEO Ryan Spencer clarified that the Q3 shingles data is an important stage-gate for advancing the program and unlocking further investment, but the ultimate decision to proceed to a pivotal trial will require a more comprehensive data package in 2026, including long-term durability and data from the older patient cohort. Spencer also noted that Dynavax is somewhat insulated from immediate FDA changes, as its next major interaction for the shingles program is not until late 2026.

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    Philip Nadeau's questions to Dynavax Technologies Corp (DVAX) leadership • Q4 2024

    Question

    Philip Nadeau asked about HEPLISAV-B's commercial performance, including Q1 2025 seasonality, the specific impact of the new Medicare reimbursement policy, and for more clarity on the hierarchy of immunological endpoints for the shingles program's go/no-go decision.

    Answer

    Chief Commercial Officer Donn Casale noted that Q1 2025 is off to a stronger start than the prior year, with a less profound sequential decline expected, driven by an earlier retail focus on non-respiratory vaccines. He explained the Medicare change allows for Part B roster billing in pharmacies, creating equal access for HEPLISAV-B. CEO Ryan Spencer and Chief Medical Officer Rob Janssen reiterated that while CD4 T-cells are critically important for the shingles program, the decision will be based on a 'constellation' of all immune response data.

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    Philip Nadeau's questions to BioMarin Pharmaceutical Inc (BMRN) leadership

    Philip Nadeau's questions to BioMarin Pharmaceutical Inc (BMRN) leadership • Q1 2025

    Question

    Philip Nadeau of TD Cowen inquired about the revenue trajectory for VOXZOGO, specifically whether a flat Q1 to Q2 trend implies a quarterly decline, and asked for quantification of the potential financial impact from hypothetical U.S. and E.U. pharmaceutical tariffs.

    Answer

    Brian Mueller, Executive Vice President and Chief Financial Officer, clarified that VOXZOGO's revenue may appear flat in the first half of 2025 due to global order timing dynamics, not a decline in patient growth, with more substantial growth expected in the second half. Regarding tariffs, he stated that while the company is modeling scenarios, it will not speculate on the financial impact of potential future tariffs until policies are clearer, noting that BioMarin's global business model provides some insulation.

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    Philip Nadeau's questions to BioMarin Pharmaceutical Inc (BMRN) leadership • Q4 2024

    Question

    Philip Nadeau questioned the deceleration in VOXZOGO's growth guidance for 2025, asking for details on the expected sources of growth by territory and the key factors that could lead to outperformance or underperformance.

    Answer

    Chief Financial Officer Brian Mueller explained that while the growth rate is decelerating from 56% in 2024, the nearly $200 million in absolute dollar growth is strong and keeps the company on track for its long-term CAGR target of over 25%. Chief Commercial Officer Cristin Hubbard added that growth will come from the U.S. (especially the 0-5 age cohort), highly penetrated markets like Germany, and expanding international markets like Brazil, supported by increased commercial investment.

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    Philip Nadeau's questions to BioMarin Pharmaceutical Inc (BMRN) leadership • Q3 2024

    Question

    Philip Nadeau inquired about the maturity of the Voxzogo launch in the U.S., asking if new patient starts are nearing the incident population, and questioned the ideal development phase for BioMarin's business development targets under $1.5 billion.

    Answer

    EVP, Chief Commercial Officer Cristin Hubbard explained that the majority of new U.S. Voxzogo starts are in the 0-5 age group due to the recent label expansion, and in markets with higher penetration, new starts are shifting to the 0-2 incident population. President and CEO Alexander Hardy added that business development will focus on leveraging BioMarin's global footprint for later-stage assets and bolstering the early-stage pipeline.

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    Philip Nadeau's questions to Apellis Pharmaceuticals Inc (APLS) leadership

    Philip Nadeau's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q4 2024

    Question

    Philip Nadeau from TD Cowen asked for more detail on the co-pay assistance funding shortage causing increased sampling and about the marketing focus for EMPAVELI in C3G/IC-MPGN.

    Answer

    CEO Dr. Cedric Francois explained the funding gap is with independent, third-party organizations and that physicians use samples to bridge this temporary gap for patients. For EMPAVELI, he highlighted the broad efficacy across all patient subgroups (C3G/ICGN, pre/post-transplant) and noted the drug is building a strong reputation among transplant nephrologists.

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    Philip Nadeau's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q3 2024

    Question

    Philip Nadeau of TD Cowen asked for the specific gross-to-net percentage in Q3 and inquired whether adverse event reports concerning a competitor's drug have had any noticeable impact on SYFOVRE prescribing.

    Answer

    CFO Timothy Sullivan clarified that the Q3 gross-to-net was at the high end of the previously guided 10% to 20% range. CEO Dr. Cedric Francois declined to comment on competitor safety issues but reiterated that Apellis believes the primary differentiator between the products is SYFOVRE's superior and durable efficacy profile.

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    Philip Nadeau's questions to Vertex Pharmaceuticals Inc (VRTX) leadership

    Philip Nadeau's questions to Vertex Pharmaceuticals Inc (VRTX) leadership • Q4 2024

    Question

    Philip Nadeau asked whether third-party prescription data for JOURNAVX would be accurate and what the expected duration of therapy would be. He also inquired about the status and resolution timeline for the royalty dispute with Royalty Pharma concerning ALYFTREK.

    Answer

    CEO Reshma Kewalramani asserted that the ALYFTREK royalty obligation is clearly defined by their contract with the CF Foundation and is not a matter of opinion. COO Stuart Arbuckle projected an average JOURNAVX script duration of around 14 days and noted that while third-party data varies, Vertex will provide its own metrics on prescriptions and covered lives.

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    Philip Nadeau's questions to Vertex Pharmaceuticals Inc (VRTX) leadership • Q3 2024

    Question

    Philip Nadeau from TD Cowen requested more detail on the commercialization of suzetrigine, asking for an update on contracting discussions with payers and inquiring about other strategic launch initiatives beyond co-pay assistance programs.

    Answer

    COO Stuart Arbuckle reported that payer discussions are progressing well, with a high appreciation for the unmet need. In addition to patient financial assistance, he highlighted a second key strategic initiative: investing to secure broad national retail distribution to ensure suzetrigine is on pharmacy shelves at launch.

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    Philip Nadeau's questions to Kura Oncology Inc (KURA) leadership

    Philip Nadeau's questions to Kura Oncology Inc (KURA) leadership • Q3 2024

    Question

    Philip Nadeau from TD Cowen asked for the mechanistic rationale behind ziftomenib's improved safety at higher doses and inquired about efforts to develop next-generation menin inhibitors for hematologic malignancies.

    Answer

    EVP of Clinical Development, Dr. Mollie Leoni, explained that higher doses lead to faster blood count recoveries, reducing patient susceptibility to infections and improving the safety profile. CEO Dr. Troy Wilson added that while they have next-gen molecules for heme malignancies, the focus is on ziftomenib in combinations, with next-gen efforts currently aimed at diabetes and other solid tumors.

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    Philip Nadeau's questions to Syndax Pharmaceuticals Inc (SNDX) leadership

    Philip Nadeau's questions to Syndax Pharmaceuticals Inc (SNDX) leadership • Q3 2024

    Question

    Philip Nadeau from TD Cowen asked if the updated KMT2A data is what the FDA is currently reviewing and whether the Revumenib dose for the frontline combination trial has been finalized with the FDA.

    Answer

    CEO Michael Metzger declined to confirm specifics of the FDA review but noted the new data is highly supportive of approval. Dr. Neil Gallagher, President and Head of R&D, confirmed that the frontline pivotal study is initiating with a Revumenib dose of 160 milligrams.

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