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    Myles Minter • William Blair

    Myles Minter's questions to Axsome Therapeutics Inc (AXSM) leadership

    Myles Minter's questions to Axsome Therapeutics Inc (AXSM) leadership • Q2 2025

    Question

    Myles Minter questioned the rationale for a single pediatric and adolescent trial for Sunosi in ADHD being sufficient for approval, given FDA guidance often suggests two studies.

    Answer

    Chief Executive Officer Dr. Herriot Tabuteau explained that there are clinical trial strategies to include both children and adolescents in a single study to determine effective dosing. He suggested that this approach, combined with the existing adult efficacy data, could provide a streamlined path to potential approval.

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    Myles Minter's questions to Axsome Therapeutics Inc (AXSM) leadership • Q1 2025

    Question

    Myles Minter of William Blair asked if Axsome has had any interaction with the 'Make America Healthy Again Commission' regarding its upcoming report. He also inquired whether the open-label extension for AXS-12 in narcolepsy will include Maintenance of Wakefulness Test (MWT) data.

    Answer

    Herriot Tabuteau, CEO, confirmed that Axsome has not had any interactions with the commission and is monitoring developments. Regarding AXS-12, he stated that the MWT was not incorporated into the open-label trial, though other measures of excessive sleepiness were used.

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    Myles Minter's questions to Axsome Therapeutics Inc (AXSM) leadership • Q4 2024

    Question

    Myles Minter asked about any material impact from the Medicare Part D restructure on Auvelity revenues and inquired about the current patient access mix between Medicare and commercial payers.

    Answer

    Chief Financial Officer Nick Pizzie stated that the company does not expect a significant impact from the Part D changes, though it might slightly alter the evolution of GTN throughout the year. Executive Darren Opland added that Medicare currently represents about 15% of Auvelity's prescription volume and no significant changes to this mix are expected for the current indication.

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    Myles Minter's questions to Axsome Therapeutics Inc (AXSM) leadership • Q3 2024

    Question

    Myles Minter of William Blair asked if the planned 300-rep sales force expansion for Auvelity anticipates securing a large GPO contract, and whether Axsome has begun payer discussions for AXS-14 (fibromyalgia), focusing on its potential fatigue benefit.

    Answer

    An executive, likely CCO Ari Maizel, clarified the expansion is based on current market access and primary care growth, not a future contract win. Regarding AXS-14, he confirmed general pipeline discussions with payers occur. COO Mark Jacobson added that the fatigue benefit is considered an important element of the AXS-14 product profile.

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    Myles Minter's questions to argenx SE (ARGX) leadership

    Myles Minter's questions to argenx SE (ARGX) leadership • Q2 22025

    Question

    Myles Minter from William Blair followed up on the CIDP safety topic, asking for an updated worsening rate now that over 2,500 patients are on therapy, and inquired if the Phase IV IVIG-to-efgartigimod switch study data is still expected this year.

    Answer

    CEO Tim Van Hauwermeiren stated that the rate of severe CIDP worsening is not increasing and remains a very small number, emphasizing that therapeutic switches inherently carry this risk in CIDP. He highlighted the transformative functional benefits seen in patients. He also confirmed the IVIG-to-efgartigimod switch study is enrolling well and on track, with data to be presented at a future clinical conference.

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    Myles Minter's questions to argenx SE (ARGX) leadership • Q1 2025

    Question

    Myles Minter asked about the real-world incidence of CIDP disease worsening when patients switch from IVIg to VYVGART Hytrulo.

    Answer

    Chief Executive Officer Tim Van Hauwermeiren explained that some risk of relapse exists with any treatment switch in CIDP. He noted that the symptom worsening seen with VYVGART is in line with historical switch studies and is a relatively small phenomenon in the real world, with low single-digit reporting. He added that switching one week after the last IVIg dose appears to be a successful strategy, which is being formally documented in a Phase IV switch study.

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    Myles Minter's questions to Neurocrine Biosciences Inc (NBIX) leadership

    Myles Minter's questions to Neurocrine Biosciences Inc (NBIX) leadership • Q2 2025

    Question

    Myles Minter from William Blair & Company asked for the discontinuation rate for Crinesity in its one-year open-label extension studies, as a potential proxy for real-world patient retention.

    Answer

    Strategic Advisor Eiry Roberts stated that discontinuation rates have been very low, noting that over 95% of patients from the pivotal trials rolled over into the open-label extensions, and many have now been on therapy for over three years with continued low discontinuation. CCO Eric Benevich added that strong insurance coverage and affordability programs should also support high persistency in the real world.

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    Myles Minter's questions to Neurocrine Biosciences Inc (NBIX) leadership • Q1 2025

    Question

    Myles Minter questioned the powering assumptions for the osavampator Phase III studies, given their relatively small size, and asked for clarification on which Phase III studies the company had initiated.

    Answer

    Chief Medical Officer Dr. Eiry Roberts clarified that the osavampator program includes three key studies. She defended the study size by explaining that extensive research suggests larger MDD trials can increase placebo response and the risk of failure. She affirmed the trials are appropriately powered based on Phase II results.

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    Myles Minter's questions to Neurocrine Biosciences Inc (NBIX) leadership • Q4 2024

    Question

    Myles Minter questioned the decision to advance the M1/M4 agonist NBI-570 into schizophrenia/acute psychosis first, rather than Alzheimer's disease psychosis, and whether this was related to a tolerability signal.

    Answer

    Chief Medical Officer Eiry Roberts explained that testing NBI-570 in the same adult acute psychosis population as their selective M4 agonist (NBI-568) is a straightforward initial step, while remaining open to other indications later. CEO Kyle Gano added that this approach allows for a valuable comparison between a dual and a selective agonist in the same patient population, which will help the company learn more about this target class.

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    Myles Minter's questions to Neurocrine Biosciences Inc (NBIX) leadership • Q3 2024

    Question

    Myles Minter of William Blair referenced a New England Journal of Medicine correspondence questioning the glucocorticoid dosing threshold used in the Crinecerfont trials and asked if payers were requesting other surrogate metrics.

    Answer

    CMO Eiry Roberts responded that the trial's definitions were negotiated closely with the FDA for what was a first-of-its-kind study in a heterogeneous population. She expressed strong confidence that the data shows the vast majority of CAH patients can benefit from Crinecerfont and that real-world experience will be important to observe post-launch. The question on payer metrics was not directly addressed.

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    Myles Minter's questions to Biogen Inc (BIIB) leadership

    Myles Minter's questions to Biogen Inc (BIIB) leadership • Q2 2025

    Question

    Jake, on behalf of Myles Minter from William Blair, asked about felzartamab for antibody-mediated rejection (AMR), inquiring how Biogen is modeling the market and how competitor data has influenced expectations.

    Answer

    CEO Christopher Viehbacher estimated the addressable AMR market at approximately $1.5 billion annually and expressed confidence that Biogen's asset will be first-to-market. Priya Singhal, EVP & Head of Development, added that the company is expanding into a fourth indication, late microvascular inflammation (MVI), a newly classified rejection phenotype that could add another 5,000-6,000 patients to the potential opportunity.

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    Myles Minter's questions to Xenon Pharmaceuticals Inc (XENE) leadership

    Myles Minter's questions to Xenon Pharmaceuticals Inc (XENE) leadership • Q1 2025

    Question

    Myles Minter asked about the powering of the X-TOLE2 study, questioning if the company assumes any erosion in effect size from Phase II to Phase III and whether they might increase enrollment beyond the 360-patient target as a mitigation strategy.

    Answer

    Chief Medical Officer Dr. Chris Kenney confirmed the study is highly powered (over 99% for the 25mg dose) for the primary endpoint and key secondaries. He noted that while effect size can vary, there is generally good consistency between Phase II and III in epilepsy. Given the robust Phase II data, the company believes the study is appropriately powered and does not plan to increase enrollment.

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    Myles Minter's questions to Silence Therapeutics PLC (SLN) leadership

    Myles Minter's questions to Silence Therapeutics PLC (SLN) leadership • FY 2024

    Question

    Myles Minter asked if a specific dose and frequency for the zerlasiran Phase III trial were proposed to regulators. He also questioned how divesiran achieves its efficacy with a modest increase in hepcidin compared to the much higher levels seen with mimetics like Rusfertide.

    Answer

    Steven Romano, Chief R&D Officer, confirmed that an optimal dose and frequency for zerlasiran were discussed with regulators but are not being disclosed publicly due to the competitive environment. Regarding divesiran, he explained that it works by manipulating endogenous physiology, and the resulting hepcidin increase, while within the physiological range, is 20-40 fold higher than the low baseline in PV patients and clearly correlates with robust clinical outcomes and a favorable safety profile.

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    Myles Minter's questions to Intellia Therapeutics Inc (NTLA) leadership

    Myles Minter's questions to Intellia Therapeutics Inc (NTLA) leadership • Q4 2024

    Question

    An analyst on behalf of Myles Minter asked for an update on how the usage of tafamidis (stabilizer) in the MAGNITUDE study is tracking against the original projection of approximately 50%.

    Answer

    CMO David Lebwohl confirmed that they are seeing 'greater usage' of tafamidis than originally projected, particularly as access expands globally. He framed this as a positive development, as it provides an opportunity to demonstrate a significant benefit on top of tafamidis, which could be a key driver of future use.

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    Myles Minter's questions to Intellia Therapeutics Inc (NTLA) leadership • Q3 2024

    Question

    A representative for Myles Minter asked about the NTLA-3001 program, specifically how many patients would be dosed before an initial data release and the target serum AAT levels for the lower dose cohorts.

    Answer

    CEO John Leonard stated that the company will report data when it is 'meaningful, consistent, and interpretable.' He reiterated that the primary objective of the program is to normalize the levels of the wild-type protein, which will be the key measure of success.

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    Myles Minter's questions to Moderna Inc (MRNA) leadership

    Myles Minter's questions to Moderna Inc (MRNA) leadership • Q4 2024

    Question

    Myles Minter asked about the expected timing for an ACIP review of the RSV vaccine and whether the high end of the 2025 revenue guidance includes sales that would require a widened recommendation.

    Answer

    President Stephen Hoge stated that broader engagement with ACIP would follow FDA approval for the expanded 18-59 high-risk population. CFO Jamey Mock confirmed that while there is a small amount of RSV growth factored into the guidance, no revenue from new product approvals or expanded indications is included in the 2025 forecast.

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