Brian

Brian asked about Scholar Rock's expectations for BLA turnaround time post-submission and the strategy for SRK-439, including whether it will remain in-house for rare neuromuscular diseases or pursue broader applications.

Answer

David Hallal, Chairman and Chief Executive Officer, reiterated confidence in the 2026 guidance for BLA resubmission and approval, citing FDA's attentiveness. Akshay Vaishnaw, President of R&D, confirmed SRK-439 is a proprietary asset for rare neuromuscular diseases, with no current partnering intentions, and further plans to be shared post-Phase I data.

Brian inquired about Scholar Rock's expectations for BLA turnaround time post-submission and the strategic plans for SRK-439, including whether it will remain in-house or be considered for broader applications.

Answer

David Hallal, Chairman and CEO of Scholar Rock, reiterated that the sole approvability issue was the Catalent facility, and they are prepared for rapid BLA resubmission. Akshay Vaishnaw, President of R&D, Scholar Rock, described SRK-439 as a highly potent, proprietary asset with no current partnering intentions, focusing on its potential in rare neuromuscular diseases.

Brian, on behalf of Andrew Tsai, asked about the primary endpoints for the Phase 2 studies in hidradenitis suppurativa (HS) and vitiligo, and the desired outcomes for advancing these programs to Phase 3.

Answer

Patrick Burnett, Chief Medical Officer, stated that for both vitiligo (Q4 2026 decision) and HS (Q1 2027 decision), the focus is on understanding the kinetic response and the fraction of patients showing meaningful clinical improvement in these open-label studies. He emphasized the importance of the timing of response and aims to replicate ZORYVE's established profile of excellent tolerability, once-a-day treatment, and rapid response, which has characterized its efficacy and safety across approved indications. This understanding will inform expectations for pivotal trials and characteristic endpoints.

Brian from Jefferies Financial Group asked for a reminder on the primary endpoints for the Phase 2 proof-of-concept studies in hidradenitis suppurativa (HS) and vitiligo, and the desired outcomes that would lead to advancing both programs to Phase 3.

Answer

Chief Medical Officer Patrick Burnett stated that for both vitiligo and HS, the focus for the Q4 2026 (vitiligo) and Q1 2027 (HS) decisions will be on understanding the kinetic response and the fraction of patients showing meaningful clinical improvement in these open-label studies. He emphasized replicating ZORYVE's profile of excellent tolerability, once-a-day treatment, and rapid response, which has characterized its efficacy and safety across approved indications.

Brian, on behalf of Josh Jennings, asked how the VA expansion is factored into the 2026 sales projections and for specific tariff assumptions underpinning the mid-80s gross margin guidance. He also sought clarification on the timeline for the NTAP for delirium, specifically if it's positioned for an October 2026 effective date or a 2027 decision.

Answer

CFO Scott Blumberg stated that the VA expansion committed last year is included in the guide, with further expansion potentially impacting late 2026/2027. He detailed tariff assumptions, noting the guide incorporates a shift from 25% to approximately 55% tariffs on China-originating products, mitigated by manufacturing in Vietnam and cost reductions, ensuring mid-80s margins. CEO Jane Chao confirmed the NTAP for delirium was submitted late last year, with a preliminary CMS decision expected in April and an October 2026 effective date if approved.

Brian asked how the VA expansion is factored into the 2026 revenue guidance and for a review of the specific tariff assumptions underpinning the mid-80s gross margin guidance. He also followed up on the NTAP for delirium, asking if Ceribell is positioned for an NTAP effective in October 2026 or if it's more likely a 2027 decision.

Answer

Scott Blumberg, Chief Financial Officer, stated that the VA expansion committed to last year is incorporated into the guide, but further expansion is not. He clarified that tariff assumptions include a move from prior 25% rates to pre-Friday aggregate rates of around 55% in China, mitigated by manufacturing in Vietnam and cost reductions, without contemplating recent policy changes. Jane Chao, Co-founder and Chief Executive Officer, confirmed that the NTAP for delirium was submitted late last year and, if received, would be effective in October 2026, with a preliminary CMS decision expected in April.

Brian, on behalf of David Vogt, asked why EV is expected to be down in FY26 despite new programs ramping, focusing on regional weakness in Europe/U.S. versus strength in China. He also inquired about the implications of a warrant deal between one of Jabil's competitors and Amazon for the industry or the company itself.

Answer

Steve Borges, EVP of Regulated Industries, Jabil, explained that the EV decline forecast reflects prudence due to automaker volatility, portfolio resets (EV, ICE, hybrid), and declining EV market share in the U.S., while noting growth in China and continued ACES strategy. Greg Hebard, CFO, Jabil, added that Jabil maintains a conservative forecasting approach. Matt Crowley, EVP of Intelligent Infrastructure, Jabil, stated that Jabil was the first EMS to do warrants with that company and views the competitor's warrant portfolio as redundant, not complimentary. He expressed no concern, expecting such deals due to high demand, and affirmed Jabil benefits from its existing agreement.

Brian from TD Cowen, on for Josh Jennings, asked about the updated gross margin guidance of 53-54% and what factors are offsetting the presumed pressure from the change in geographic sales mix.

Answer

EVP, CFO & Treasurer Leigh Vosseller explained that the 53-54% range is purely a reflection of the updated geographic mix. However, she highlighted key drivers for margin expansion, including improving cost-per-unit for the Mobi platform as volumes scale and the higher-margin opportunity from expanding into the pharmacy channel, particularly with t:slim supplies.