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    Graig Suvannavejh • Mizuho Securities

    Graig Suvannavejh's questions to Verastem Inc (VSTM) leadership

    Graig Suvannavejh's questions to Verastem Inc (VSTM) leadership • Q2 2025

    Question

    Graig Suvannavejh asked for a reminder on the commercial effort's sizing and its potential evolution, including the role of IQVIA. He also sought color on the typical considerations for the NCCN committee's review process to gauge confidence in getting a broader label recommendation.

    Answer

    President and CEO Dan Paterson explained that the NCCN committee looks at the totality of data and that having LGSOC experts in the room to advocate based on the new publications is key. Chief Commercial & Strategy Officer Michael Crowther stated the company will continue with its focused field team targeting top accounts, supplemented by digital and GPO programming. Paterson praised the partnership with IQVIA, noting it was critical for getting data infrastructure ready for the early launch.

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    Graig Suvannavejh's questions to Insmed Inc (INSM) leadership

    Graig Suvannavejh's questions to Insmed Inc (INSM) leadership • Q2 2025

    Question

    Graig Suvannavejh inquired about the interim futility analysis for brensocatib in hidradenitis suppurativa (HS), asking about the success bar and the potential target profile for next-generation DPP1 inhibitors.

    Answer

    CMO Martina Flammer explained the HS futility analysis will be based on a 'signal of efficacy' in the first 100 patients, not a specific p-value, and will be assessed by an independent expert panel. CEO William Lewis added that while brensocatib development is limited to its current indications, the next-generation DPP1 inhibitors will target large diseases like COPD, asthma, and IBD, with each new molecule aimed at a specific disease to navigate IRA constraints.

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    Graig Suvannavejh's questions to Insmed Inc (INSM) leadership • Q1 2025

    Question

    Graig Suvannavejh asked for more detail on payer discussions for Brensocatib's launch, specifically regarding pricing expectations and the anticipated gross-to-net percentage.

    Answer

    CEO William Lewis reported positive pre-approval discussions with payers. CFO Sara Bonstein reiterated the price range of $40k-$96k, expecting to be in the upper half. For gross-to-net, she guided to a reasonable range of 25%-35%, factoring in the impact of Medicare catastrophic coverage and analogs from other specialty launches.

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    Graig Suvannavejh's questions to Insmed Inc (INSM) leadership • Q1 2025

    Question

    Graig Suvannavejh asked for more detail on payer discussions for Brensocatib, seeking insights on pricing direction and expected gross-to-net percentages for modeling purposes.

    Answer

    CEO William Lewis described payer discussions as 'very positive' and reiterated confidence in the previously stated price range. CFO Sara Bonstein confirmed the price range of $40k-$96k and expects pricing in the upper half. For gross-to-net, she stated that while not formal guidance, a range of 25% to 35% seems reasonable based on analogs and the impact of IRA catastrophic coverage for Medicare patients.

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    Graig Suvannavejh's questions to Insmed Inc (INSM) leadership • Q4 2024

    Question

    Graig Suvannavejh inquired about the early-stage pipeline, asking how the gene therapy candidate for DMD differentiates itself and requesting details on the targets for the ALS and Stargardt programs.

    Answer

    CEO Will Lewis explained the DMD program's novelty lies in its intrathecal delivery of an AAV9 capsid to produce microdystrophin. He stated the ALS program targets both SOD1 and sporadic patients, and the Stargardt program uses a novel RNA end-joining technology to construct a larger transgene in vivo. He indicated that clinical data from these programs would likely begin to arrive in 2026.

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    Graig Suvannavejh's questions to Insmed Inc (INSM) leadership • Q3 2024

    Question

    Graig Suvannavejh of Mizuho Securities asked about the trend in operating expenses, the prioritization of the early-stage pipeline amidst late-stage activities, and requested a reminder of the readout timing for the ARIKAYCE ENCORE study.

    Answer

    CEO Will Lewis confirmed the ENCORE study readout is expected in early 2026 and stressed that the early-stage pipeline (the "fourth pillar") is progressing well, with a goal of 1-2 INDs per year starting within 12 months. CFO Sara Bonstein addressed OpEx, stating the increase was in line with internal plans, driven by SG&A for the sales force expansion and brensocatib launch readiness, and R&D investments across the portfolio, including medical affairs.

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    Graig Suvannavejh's questions to Insmed Inc (INSM) leadership • Q3 2024

    Question

    Graig Suvannavejh asked about the trend for operating expenses, the prioritization of the early-stage pipeline, and the expected readout timing for the ENCORE study.

    Answer

    CEO Will Lewis confirmed the ENCORE readout is expected in early 2026 and emphasized that the early-stage pipeline is a key priority, aiming to produce 1-2 INDs annually starting within the next year. CFO Sara Bonstein addressed OpEx, stating the quarterly increase was expected due to investments in the expanded sales force and launch readiness for brensocatib, with continued R&D spending across the portfolio.

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    Graig Suvannavejh's questions to Harmony Biosciences Holdings Inc (HRMY) leadership

    Graig Suvannavejh's questions to Harmony Biosciences Holdings Inc (HRMY) leadership • Q2 2025

    Question

    Graig Suvannavejh from Mizuho Financial Group asked about the strategic rationale for the new SERC Biosciences collaboration, particularly the choice of a cell therapy approach, and how this fits into Harmony's broader business development strategy.

    Answer

    President & CEO Dr. Jeffrey Dayno framed the deal as an early-stage, strategic collaboration for next-generation therapies in refractory epilepsy and narcolepsy. Chief Medical & Scientific Officer Dr. Kumar Budur detailed the platform's technical advantages over traditional stem cells. CFO & CAO Sandip Kapadia emphasized Harmony's strong cash position ($672M) and disciplined approach to deploying capital in an attractive market.

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    Graig Suvannavejh's questions to Harmony Biosciences Holdings Inc (HRMY) leadership • Q1 2025

    Question

    Graig Suvannavejh asked about the powering assumptions and risk mitigation strategies for the ZYN002 RECONNECT study, and also asked new CCO Adam Zaeske for his initial impressions of the WAKIX commercial strategy.

    Answer

    Dr. Kumar Budur, Chief Medical and Scientific Officer, stated the RECONNECT study is powered at over 90% for its primary endpoint and detailed rigorous patient selection and caregiver training to ensure data quality. Adam Zaeske, Chief Commercial Officer, shared that his initial focus is on learning and listening, with the goal of continuing WAKIX's strong performance and preparing for future launches by evaluating potential strategic tweaks.

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    Graig Suvannavejh's questions to Harmony Biosciences Holdings Inc (HRMY) leadership • Q4 2024

    Question

    Graig Suvannavejh asked for an update on the WAKIX patent litigation following the Novugen settlement, inquiring about the status and number of remaining challenges and upcoming legal timelines.

    Answer

    Dr. Jeffrey Dayno, President and CEO, confirmed the Novugen settlement is with one of seven ANDA filers. He stated that legal processes continue, with a Markman hearing scheduled for March, followed by a trial in 2026. While unable to comment on active litigation, he noted the settlement reinforces the strength of their IP portfolio.

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    Graig Suvannavejh's questions to Harmony Biosciences Holdings Inc (HRMY) leadership • Q3 2024

    Question

    Graig Suvannavejh asked about Harmony's commercial strategy for managing the coexistence of WAKIX, pitolisant GR, and pitolisant HD, and inquired about the timeline for releasing more preclinical data on its orexin agonist program.

    Answer

    Chief Commercial Officer Jeffrey Dierks explained that WAKIX remains foundational, with pitolisant GR serving as an accretive launch to capture new and previously discontinued patients. He noted pitolisant HD is expected to become the primary product, with most patients likely converting due to its superior profile. Chief Medical and Scientific Officer Dr. Kumar Budur and CEO Dr. Jeffrey Dayno added that the full preclinical data for the orexin program is targeted for presentation at a scientific meeting in the next year.

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    Graig Suvannavejh's questions to Axsome Therapeutics Inc (AXSM) leadership

    Graig Suvannavejh's questions to Axsome Therapeutics Inc (AXSM) leadership • Q2 2025

    Question

    Graig Suvannavejh asked about expected summer seasonality for the three commercial products and for an update on the potential timing of IRA pricing negotiations for Auvelity.

    Answer

    Chief Commercial Officer Ari Maizel confirmed summer seasonality across all three markets, particularly depression. Chief Financial Officer Nick Pizzie addressed the IRA, stating that Auvelity would likely face negotiations around 2029-2030, with potential price implementation in the 2031-2032 timeframe.

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    Graig Suvannavejh's questions to Axsome Therapeutics Inc (AXSM) leadership • Q1 2025

    Question

    Graig Suvannavejh of Mizuho Securities asked a high-level question about profitability, inquiring if it could be achieved on a quarterly basis in 2025. He also followed up on the expected evolution of R&D and SG&A spending for the remainder of the year.

    Answer

    Nick Pizzie, CFO, reiterated confidence in reaching cash flow positivity with the current cash on hand but did not provide specific guidance on the timing of profitability. He explained that R&D spending is expected to increase from Q1 levels due to new trial initiations and an NDA filing fee in Q2. SG&A will also rise with the hiring for the SYMBRAVO launch and a DTC campaign later in the year.

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    Graig Suvannavejh's questions to Axsome Therapeutics Inc (AXSM) leadership • Q4 2024

    Question

    Graig Suvannavejh asked about expectations for the PARADIGM study of solriamfetol in MDD, its potential positioning relative to Auvelity, and the anticipated launch trajectory for Symbravo.

    Answer

    CEO Dr. Herriot Tabuteau suggested that if solriamfetol is effective in MDD, a natural positioning would be for patients with comorbid depression and excessive daytime sleepiness. CCO Ari Maizel noted that for Symbravo's uptake, recent oral CGRP launches are the best analogs, but Axsome's launch will be more targeted to headache specialists and neurologists with a smaller sales force.

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    Graig Suvannavejh's questions to Axsome Therapeutics Inc (AXSM) leadership • Q3 2024

    Question

    Graig Suvannavejh of Mizuho Securities asked for Axsome's perspective on potential outcomes for the two upcoming Phase III ADA trials and how a positive result in only one would impact a filing. He also asked for guidance on Auvelity's gross-to-net (GTN).

    Answer

    CEO Herriot Tabuteau stated that with two prior positive pivotal studies, a positive result from either of the two ongoing trials would result in at least three positive trials, strongly supporting an NDA filing. CFO Nick Pizzie guided for Auvelity's GTN to remain around 50% or worsen slightly in Q4, with a negative seasonality impact in Q1 2025.

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    Graig Suvannavejh's questions to Apellis Pharmaceuticals Inc (APLS) leadership

    Graig Suvannavejh's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q2 2025

    Question

    Graig Suvannavejh of Mizuho revisited the topic of market growth, asking for insight on a competitor's projection of high-20s quarterly growth and whether Apellis's low to mid-single-digit view for Cyfovri might be conservative.

    Answer

    CEO Dr. Cedric Francois reiterated Apellis's clear market leadership across all key metrics. He stressed that Apellis has a better grasp on the market dynamics, supported by superior long-term (4-year) data and a more comprehensive market tracking system, compared to the competitor's reliance on older, 1-year data.

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    Graig Suvannavejh's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q1 2025

    Question

    Graig Suvannavejh asked about the future growth dynamics for SYFOVRE and the broader complement inhibitor class, questioning whether to expect a slow, steady grind or if a significant inflection point is still possible.

    Answer

    Executive Cedric Francois characterized the current environment as one of steady growth that takes time for adoption. He identified potential acceleration points, particularly the development of AI tools that will help physicians and patients visualize the drug's protective effect on retinal tissue and its impact on visual function. Executive Caroline Baumal added that data-driven tools from their large dataset will help physicians understand the disease and patient response, which will help grow the market.

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    Graig Suvannavejh's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q3 2024

    Question

    Graig Suvannavejh of Mizuho Securities asked for the company's long-term, aspirational view on the potential peak market penetration for the complement inhibitor class in geographic atrophy, given the current penetration is around 15%.

    Answer

    CMO Dr. Caroline Baumal responded that they are 'just at the start' and that 'no one should be comprised of this treatment.' She expressed optimism that with an aging population and continued education across the entire eye care provider market, not just retina specialists, the penetration rate for this chronic disease will continue to increase significantly over time.

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    Graig Suvannavejh's questions to Corvus Pharmaceuticals Inc (CRVS) leadership

    Graig Suvannavejh's questions to Corvus Pharmaceuticals Inc (CRVS) leadership • Q1 2025

    Question

    Graig Suvannavejh inquired about the modified Phase I study, seeking clarification on the dosing regimen for the extension cohort. He also asked about the change in EASI 75 data for Cohort 2 and the potential contribution of the remaining four patients in Cohort 3. He concluded by asking for a timeline for the complete Cohort 3 data release.

    Answer

    Richard Miller, an executive, clarified that the extension cohort will exclusively test the 200-milligram BID dose. He explained that the slight drop in Cohort 2's EASI 75 results was due to small numbers and some patients being very close to the threshold. He expressed confidence in the Cohort 3 data, noting the tight standard error bars and consistent results at day 15. Miller stated that the complete Cohort 3 data could be shared in a press release within a month or two.

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    Graig Suvannavejh's questions to Corvus Pharmaceuticals Inc (CRVS) leadership • Q4 2024

    Question

    Speaking on behalf of Graig Suvannavejh, an analyst asked about the new indication, autoimmune lymphoproliferative syndrome (ALPS), seeking details on the addressable patient population and whether a specific subset of ALPS patients would be ideal candidates for soquelitinib.

    Answer

    Executive Richard Miller provided a detailed background on ALPS, a genetic disease affecting about 2,500 patients in the U.S. He explained that soquelitinib was dramatically effective in a mouse model with the identical genetic mutation. Miller stated that there is no known patient subset that would be more or less amenable to the therapy. He highlighted the trial as a key opportunity to study the drug's effect on various autoimmune manifestations, which could have relevance for other diseases.

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    Graig Suvannavejh's questions to Corvus Pharmaceuticals Inc (CRVS) leadership • Q3 2024

    Question

    Graig Suvannavejh of Mizuho Securities sought details on the specific EASI score metrics to be reported for the atopic dermatitis trial, the competitive bar for an oral agent versus injectables, and the broader landscape of oral therapies in development.

    Answer

    Executive Richard Miller confirmed the company will report a full range of efficacy metrics, including mean EASI reduction and EASI-50/75/90 scores. He expressed confidence in the drug's mechanism, stating the goal is to be superior to, not just comparable with, injectable therapies like Dupixent. He declined to comment in detail on other oral competitors.

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    Graig Suvannavejh's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership

    Graig Suvannavejh's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership • Q1 2025

    Question

    Sam on behalf of Graig Suvannavejh at Mizuho Securities asked if recent shortages in co-pay assistance programs were impacting trial enrollment and what specific trial design factors were driving enrollment versus competitors.

    Answer

    CEO Dr. Jay Duker confirmed that the lack of funding for the 'Good Days' co-pay program is likely helping enrollment for all wet AMD trials, as study participation offers treatment at no cost. Chief Medical Officer Dr. Ramiro Ribeiro reiterated that the key differentiator driving enrollment is the robust Phase II data, which gives physicians confidence in DURAVYU's efficacy and safety, along with a patient-centric design and strong site support.

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    Graig Suvannavejh's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership • Q4 2024

    Question

    Graig Suvannavejh asked for an update on the Northbridge manufacturing facility, its expected progress, and how the company is mitigating potential CMC (Chemistry, Manufacturing, and Controls) risks.

    Answer

    CFO George Elston highlighted that the state-of-the-art facility is online and the team has begun activities for registration batches to support an NDA filing. President and CEO Dr. Jay Duker added that the facility was built with foresight to meet FDA and EMA specifications and is expected to supply the entire global demand for DURAVYU.

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    Graig Suvannavejh's questions to Immunocore Holdings PLC (IMCR) leadership

    Graig Suvannavejh's questions to Immunocore Holdings PLC (IMCR) leadership • Q4 2024

    Question

    Representing Graig Suvannavejh of Mizuho Securities, an analyst asked for an update on brenetafusp's data generation efforts in ovarian and lung cancers, including any changes to patient recruitment and the timeline for the next data release.

    Answer

    David Berman, Head of R&D, detailed the strategy, which includes expanding brenetafusp into chemo combinations for platinum-resistant ovarian cancer and exploring combinations with osimertinib and docetaxel in lung cancer. He indicated that data would be shared within the next 12 to 18 months, once a comprehensive data story is available.

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