Roanna Ruiz

Roanna Ruiz inquired about potential future updates to the United Therapeutics (UT) supply contracts for Tyvaso DPI and sought insights into the tailwinds driving future revenue growth for Afrezza and FUROSCIX, specifically considering new guideline updates for Afrezza and the anticipated auto-injector launch for FUROSCIX.

Answer

Michael Castagna (CEO) clarified that while the supply agreement could be mutually modified, it was established with minimums to ensure long-term Danbury operations. He detailed Afrezza's shift to a growth mindset, driven by the potential pediatric launch and increased investment, expecting growth in Q3 and Q4. For FUROSCIX, he highlighted the auto-injector's potential to transform the patient experience and drive growth, with an expected PDUFA date in July, noting no significant FDA showstoppers for either approval.

Roanna Ruiz with Leerink Partners inquired about the potential for future updates to the United Therapeutics (UT) supply contracts for Tyvaso DPI, contingent on its market ramp. Additionally, she asked about the key growth drivers for Afrezza and FUROSCIX in the current and upcoming years, specifically highlighting the impact of new guideline updates for Afrezza and the anticipated auto-injector launch for FUROSCIX.

Answer

CEO Michael Castagna explained that the supply agreement now includes minimums to ensure long-term Danbury facility operations, noting that any modifications would require mutual agreement. He detailed Afrezza's shift to a growth mindset, driven by the pediatric indication (Peds) as an inflection point, with increased investment and an expected May approval leading to growth in Q3 and Q4. For FUROSCIX, Mr. Castagna emphasized the significant value of the auto-injector for ease of use and patient experience, anticipating a meaningful transformation with its expected July launch.

Roanna Ruiz asked for elaboration on Lantheus' strategy to pursue value-maximizing alternatives for radiotherapeutic assets, inquiring about specific product features being sought, potential near-term business development activities, and how this aligns with the mentioned opportunistic diagnostic tuck-in acquisitions for the year.

Answer

Mary Anne Heino (Executive Chairperson and Interim CEO) explained that the strategy is a natural outcome of portfolio diversification, aiming to ensure the value of each asset is considered, as Lantheus cannot advance the entire portfolio internally. The focus is on diagnostic assets, while therapeutic assets will be driven through external or partnered alternatives, with more details to come. She clarified that PNT2003 is excluded from this, as it's a near-term regulatory approval opportunity and a natural fit for the existing portfolio and customer base. Ms. Heino also reiterated openness to opportunistic diagnostic tuck-ins.

Roanna Ruiz inquired about Lantheus's strategy to pursue value-maximizing alternatives for radiotherapeutic assets to support long-term growth. She asked for more details on the specific product features being sought, potential near-term business development activities, and the scope for opportunistic tuck-in acquisitions.

Answer

Mary Anne Heino (Executive Chairperson and Interim CEO, Lantheus) explained that this strategic shift is a natural outcome of their portfolio expansion, focusing on diagnostic assets. She stated their obligation to shareholders is to ensure the value of each asset is considered, and they will pursue external or partnered alternatives for therapeutic assets, excluding PNT2003 due to its near-term regulatory approval and fit within their portfolio. Ms. Heino confirmed openness to opportunistic diagnostic tuck-ins that align with their strategy.

Roanna Ruiz inquired about the human-based studies conducted for the new soft mist inhaler (Tresmi), specific optimization features, and anticipated physician reactions to its commercial availability.

Answer

Martine Rothblatt, Chairperson and Chief Executive Officer, indicated that physicians and patients would be very pleased with Tresmi due to its equivalent effectiveness and easier tolerance compared to dry powder. She noted that specific competitive advantages would remain undisclosed until FDA approval, but confirmed filing this year and commercial launch next year.

Roanna Ruiz from Leerink Partners asked for more details on United Therapeutics' new Tresmi soft mist inhaler, specifically regarding human-based study results, optimized features, and anticipated physician reception upon commercialization.

Answer

Dr. Martine Rothblatt (Chairperson and CEO) indicated that physicians would be very pleased due to anticipated patient satisfaction, as Tresmi offers equivalent efficacy with easier tolerability than dry powder. She noted that specific competitive advantages would remain undisclosed until FDA approval, with filing planned for this year and launch next year.

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.

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 asked for insights into the initial MYQORZO launch, focusing on the time taken for sites and clinical centers to complete REMS certification and begin prescribing, and any observations from field representatives regarding this process.

Answer

President and CEO Robert Blum and EVP and Chief Commercial Officer Andrew Callos highlighted that REMS certification typically takes 10-20 minutes and has not been a barrier. They noted strong engagement and swift certification, attributing it to cardiologists' familiarity with CMI REMS programs.

Roanna Ruiz inquired about the initial launch of MYQORZO, focusing on the time it takes for sites and clinical centers to complete REMS certification and begin prescribing, and any observations from the field representatives.

Answer

Robert Blum, President and CEO, and Andrew Callos, EVP and CCO, noted that REMS certification is a quick 10-20 minute process and has not been a barrier. They observed strong engagement and swift REMS certification from cardiologists, many of whom were already familiar with CMI REMS programs.

Roanna Ruiz inquired about how the Astellas collaboration will unlock resources for investing in the broader PRO-XTEN platform and other solid tumor indications, and how Vir Biotechnology plans to prioritize programs. She also asked how the larger VIR-5500 patient cohort data evolves thinking on its positioning within the prostate cancer treatment paradigm.

Answer

Marianne De Backer, CEO and Director, explained that Astellas' internal development capabilities will accelerate VIR-5500, allowing Vir Biotechnology to leverage expenses for other programs and accelerate them. Mark Eisner, EVP and Chief Medical Officer, stated that VIR-5500 aims to address a broad range of patients, including late-line mCRPC monotherapy, early-line mCRPC in combination, and metastatic hormone-sensitive prostate cancer in combination.

Roanna Ruiz inquired about how the Astellas collaboration will unlock resources for investing in the broader PRO-XTEN platform and other solid tumor indications, and the calculus for prioritizing programs. She also asked how the larger VIR-5500 patient cohort evolves thinking on its positioning within the treatment paradigm.

Answer

Marianne De Backer, CEO and Director, explained that Astellas' internal development capabilities will accelerate VIR-5500 and allow Vir Biotechnology to leverage expenses for other programs. Mark Eisner, EVP and Chief Medical Officer, stated that they aim to address a broad range of metastatic prostate cancer patients, including late-line mCRPC monotherapy, early-line mCRPC in combination (with Xtandi), and metastatic hormone-sensitive prostate cancer in combination.

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.

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.