Roanna Ruiz

Roanna Ruiz questioned the outlook for DefenCath revenues and pricing dynamics in the second half of 2026 post-TDAPA, including factors that could influence revenue. She also asked about the goals and data used in current customer discussions regarding the post-TDAPA period.

Answer

CEO Joe Todisco stated that the company is not yet ready to provide clarity on H2 2026, but anticipates price compression post-TDAPA as reimbursement shifts from ASP to an add-on. He noted that the proposed CMS methodology could lead to a lower adjustment in Q3/Q4 2026 compared to 2027, and they await the final ESRD rule. Todisco highlighted that real-world evidence data, expected by year-end, will be critical for customer discussions, along with anecdotal feedback on reduced infection rates.

Roanna Ruiz with Leerink Partners inquired about the expected DefenCath revenues and pricing dynamics for the second half of 2026 post-TDAPA, including factors that could influence revenue. She also asked about the objectives and supporting data used in current customer discussions regarding the post-TDAPA period.

Answer

CEO Joe Todisco explained that price compression is expected post-TDAPA due to the shift from ASP to an add-on method, pending potential legislation. He noted that CMS's proposed methodology could lead to lower adjustments in Q3/Q4 2026 compared to 2027. Todisco emphasized that real-world evidence data, expected by year-end, will be critical for demonstrating DefenCath's impact on the healthcare system and supporting discussions with customers, who have already provided anecdotal positive feedback on infection rate reductions.

Roanna Ruiz inquired about the launch plans for the new 80 micrograms cartridge for Tyvaso DPI, including strategies to drive durable patient use and potential switching from prior cartridges.

Answer

Martine Rothblatt, Founder, Chairman, and CEO, referred the question to Pat Poisson, Executive Vice President of Strategic Development. Pat Poisson explained that the 80 micrograms cartridge offers added convenience for patients requiring higher doses, allowing them to achieve 15 breaths in a single dose, compared to combining two cartridges previously. He stated the launch is anticipated very soon, within 30-60 days, to facilitate easier dosing.

Roanna Ruiz inquired about the launch plans for the new 80 μg cartridge for Tyvaso DPI, including strategies to drive patient use and potential switching from prior cartridges.

Answer

Martine Rothblatt, Founder, Chairman, and CEO, referred the question to Pat Poisson, EVP of Strategic Development. Pat Poisson explained that the 80 μg cartridge was developed for patient convenience, allowing them to achieve a 15-breath equivalent in a single dose, which previously required combining two cartridges. He anticipated the launch very soon, within the next 30 to 60 days, aiming to provide easier dosing and added convenience for patients titrating to higher doses.

Asked about the commercialization and partnership strategy for sotagliflozin in HCM across different regions and about baseline therapy requirements for the SONATA trial.

Answer

Viatris holds the license for sotagliflozin ex-U.S. and ex-Europe. Lexicon would seek a partner for Europe. For the U.S., Lexicon feels it has the capability to commercialize for HCM itself, noting a more favorable payer environment than for heart failure, but is open to partnerships. For the SONATA trial, there are no limitations on background therapy (including CMIs); the main inclusion criterion is that patients remain symptomatic with a low KCCQ score.

Asked about the rationale behind the Viatris partnership for sotagliflozin, the company's strategy for prioritizing future partnerships for its pipeline assets, and the potential positioning and differentiating features of LX9851 in the obesity treatment landscape.

Answer

The Viatris deal was driven by the need for a strong global partner with cardiometabolic expertise to commercialize sotagliflozin outside the US/EU. Partnering for LX9211 and LX9851 is a key focus. LX9851 is positioned as a differentiated oral small molecule with a novel mechanism that could be used in combination, preserve lean body mass, and serve as a maintenance therapy, complementing existing GLP-1 treatments.

Inquired about the rationale for choosing the Chronic Spontaneous Urticaria (CSU) indication, the optimization process for the candidate molecule, and the efficacy/safety expectations for the upcoming RSVPEDs data that would support advancing to Phase 3.

Answer

The company is optimizing its CSU candidate for potency, selectivity, and PK. They chose CSU based on a rigorous process and are exploring other immunology targets. For RSVPEDs, they are looking for positive directional trends in virology to support a move to Phase 3, given the study's small size.