Prakhar Agrawal • Cantor Fitzgerald

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CEO Matt Gline reiterated that the trial protocol focuses on consistently defining 'rescue therapy' for worsening patients, rather than specifying a steroid dose for 'flares.' Regarding business development, Gline confirmed Roivant is an 'agnostic hunter' that actively looks in China, noting the high quality and rapid development of drug candidates from the region, particularly for mechanisms where creative clinical development can add significant value.

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CEO & Director Matt Gline confirmed that the steroid taper is mandatory and follows a clear, consistently applied protocol. He mentioned that other risk-mitigation strategies are in place, such as managing discontinuations and measurement time points. He emphasized that strong site relationships and "boots on the ground" work help ensure protocol adherence, and deferred more detailed discussion to the upcoming investor event.

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CEO Christopher Anzalone noted Sarepta's shares are still in lockup and that there has been inbound interest, mitigating concerns about a potential sale. SVP Andy Davis detailed medical education efforts for SHTG. Anzalone emphasized that plozasiran is a 'pancreatitis drug,' not a standard lipid drug, which should inform its value and pricing.

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An executive expressed that relying on such an endpoint was a high-risk strategy. He reiterated that Arrowhead's program is designed to meet the high standards of European payers by focusing on 'definite' pancreatitis in a purpose-built outcomes study (SHASTA-5), which he believes is a more robust approach for health authorities.

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CMO Dr. Jula Inrig explained that the focus for FSGS is on proteinuria, not eGFR, per the Parasol findings, and the eGFR curves are consistent with expectations (acute decline then stabilization). CFO Chris Cline addressed gross-to-net, noting relief in Q2 and that they remain squarely in line with the full-year guidance of the low 20% range.

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CEO Eric Dube and CCO Peter Heerma responded. Dube stated that while broad access is key, a higher price for FSGS is likely given the double dose and is justified by the high unmet need. Heerma added that a rapid uptake is expected due to significant prescriber overlap, strong brand awareness, established payer access, and the recognized urgency to treat FSGS.

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SVP of R&D, Dr. Bill Rote, responded that while it is an FDA decision, an agency official has publicly stated the pathway will not remain open indefinitely. With three approved therapies now available, Dr. Rote believes the unmet need has been significantly addressed, raising the bar for future accelerated approvals. He does not expect many more drugs to successfully use that pathway for IgAN.

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CEO Mike Raab acknowledged historical trends but emphasized the current $10 million guidance increase for Ibsrela was a significant and thoughtful step. He declined to provide specific guidance for Xphozah but highlighted the strong $25 million Q2 performance and month-over-month demand growth since March as a positive trajectory.

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CEO Michael Raab outlined the strategy, which involves a closed distribution system via ArdelyxAssist. This system removes the burden from physicians to differentiate between insurance types. The program adjudicates prescriptions, transitioning Medicare patients who qualify to the patient assistance program for free drug, while processing non-Medicare prescriptions through their respective payers.

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CEO Michael Weiss confirmed that preliminary bioavailability data supports both every-other-month and quarterly dosing for subcutaneous BRIUMVI, with an injection volume likely near 2ml. Chief Commercial Officer Adam Waldman added that the sequential revenue growth was driven mostly by volume. He reiterated the full-year gross-to-net guidance of 70-75%, noting Q2 was closer to 70% due to increased sales in the hospital segment, which has higher mandated discounts.

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CEO Michael Weiss confirmed the subcutaneous trial remains on track to start this year and that the decision to invest in myasthenia gravis depends on an aggregate of market factors, not a single data point. CCO Adam Waldman added that while there is a 'healthy amount' of switches from Ocrevus, the trend has remained consistent since launch without a notable inflection.

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Chief Commercialization Officer Adam Waldman attributed the growth to broad customer adoption in both academic and private clinic settings, driven by strong 5-year data, real-world evidence, and an expanded field team. Regarding the competitor's high-dose product, both Waldman and CEO Michael Weiss stated it was too early to comment without seeing the full data profile, including infusion time and safety.

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Chief Commercialization Officer Adam Waldman reported seeing no impact from the subcutaneous OCREVUS launch to date, highlighting that October was a record enrollment month. CEO Michael Weiss confirmed the share buyback will continue but emphasized that capital will also be allocated to growing BRIUMVI's commercial efforts, funding clinical programs, advancing azer-cel, and pursuing business development.

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President and CEO Adam Steensberg confirmed that ZUPREME-2 will test similar top doses as ZUPREME-1. He argued that CagriSema data showed significant additional weight loss and that its amylin component was likely under-dosed. Chief Medical Officer David Kendall added that ZUPREME-2, as a monotherapy trial, will better assess amylin's full potential, which they hypothesize will show comparable weight reduction in patients with and without diabetes.

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President and CEO Adam Steensberg emphasized that a U.S. co-commercialization structure is 'extremely important' for any partnership. Regarding competitor data, he noted that while the cagrilintide mono-arm will be informative, petrelintide's higher dosing potential makes their own Phase IIb trial critical. Chief Medical Officer David Kendall explained their confidence in a dose response is based on preclinical data and factors in the Phase Ib trial, such as the limited number of female participants, which the larger Phase IIb is designed to clarify.

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CEO Adam Steensberg and CMO David Kendall replied. Dr. Kendall attributed confidence in a dose response to individual patient data and the potential for greater separation with longer duration in Phase IIb. Mr. Steensberg emphasized that a key partnership term is a shared vision for petrelintide as a foundational therapy with co-commercialization rights. He noted the cagrilintide mono-arm data will be insightful but stressed petrelintide's potential for much higher dosing.

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CEO William Sibold and CFO Mardi Dier both stated it was too early to comment on 2026 gross-to-net specifics but reiterated a disciplined, long-term strategy. Regarding business development, Dier confirmed they are not pursuing a 'bet the company' strategy and that their strong cash position supports current launch plans, though a future deal could alter the cash flow outlook.

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CEO William Sibold clarified that gastroenterologists are the vast majority of their target prescribers and have been the driving force of the launch's success. He explained that any initial slowness was mechanical, related to 'wiring' their practices for a new disease, but their adoption has been extremely strong and is critical to the product's performance.

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CEO William Sibold stated that patient and prescriber additions were steady and consistent throughout the quarter, with the strong quarterly results reflecting a cumulative effect. He declined to provide monthly breakdowns. CFO Mardi Dier referred back to earlier remarks indicating Q4 growth is expected to track with successful specialty launches.

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