Mazahir Alimohamed

Mazahir Alimohamed of Leerink Partners inquired about the likelihood of an FDA Advisory Committee (AdCom) meeting for Anafilm and the company's confidence in its clinical data package.

Answer

CEO Daniel Barber stated that Aquestive expects clarity on a potential AdCom in the coming weeks following the FDA's mid-cycle review and that the company is prepared. Chief Medical Officer Dr. Carl Kraus affirmed confidence in the robust clinical package, highlighting it as one of the largest epinephrine studies conducted, with 10 independent studies and over 930 exposures.

Mazahir Alimohamed from Leerink Partners questioned the outlook for Auryxia's competitive dynamics for the remainder of 2025, given its year-over-year revenue growth despite an authorized generic on the market. He also asked how Akebia is positioning for potential future generic entrants.

Answer

SVP & CCO Nicholas Grund attributed Auryxia's strong performance to physician familiarity and significantly improved market access. CEO John Butler noted that while they have visibility on the current authorized generic, they remain cautious about future competition. CFO Erik Ostrowski added that the company budgets conservatively for Auryxia, and any delay in further generic entry represents upside to their financial plan.

Mazahir Alimohamed from Leerink Partners questioned how Vertex's recent trial failure in pain impacts Lexicon's confidence and asked if the baseline echo required in the sotagliflozin HCM trial would be a commercial requirement.

Answer

CEO Mike Exton asserted that Vertex's results actually increase confidence in pilavapitan, as it validates their novel mechanism of action which has shown consistent efficacy, unlike the mixed results for NaV inhibitors in neuropathic pain. SVP & CMO Dr. Craig Granowitz explained that a baseline echo is standard of care for heart failure patients and is not expected to be a commercial barrier, distinguishing it from the frequent monitoring and REMS programs required for CMIs.

Mazahir Alimohamed of Leerink Partners requested details on the commercial opportunity for tau imaging agent MK6240 and its strategic fit within the company's broader Alzheimer's franchise alongside NeuroSeq.

Answer

CEO Brian Markison described tau imaging's value as "unmistakable" for future patient selection and monitoring in clinical trials, with the potential for the neuro portfolio to be similar in size to Polarify. President Paul Blanchfield added that the acquired LMI team provides a strong commercial platform to launch MK6240 and lead the neuro PET diagnostic market.

Mazahir Alimohamed, on behalf of Roana Ruiz at Leerink Partners, questioned the realistic expectations for European market penetration over the next three to five years under the Recordati partnership and how Recordati's broader reach into primary care differentiates its approach from Amarin's previous specialty-focused strategy.

Answer

CEO Aaron Berg explained that it is too early to provide long-term forecasts for Europe but expressed optimism for accelerated growth. He highlighted the key strategic difference: Amarin's direct approach was limited and focused on specialists, whereas Recordati has a well-established infrastructure in both specialty cardiology and primary care. This broader reach is expected to enable a greater commercial impact and wider patient access than Amarin could have achieved alone.

Mazi Alimohamed of Leerink Partners asked about Amarin's plans for generating additional real-world evidence or clinical data to expand VASCEPA's labeling or strengthen its differentiation against generics and emerging lipid management therapies.

Answer

President and CEO Aaron Berg and executive Steven Ketchum responded. Berg stated that Amarin is continuously generating new data to differentiate the product, highlighting its unique ability to address residual cardiovascular risk. Ketchum added that the company continues to mine the rich REDUCE-IT dataset, present findings at major medical congresses on mechanisms of action, and support external collaborations to reinforce the drug's scientific foundation.

Eason Lee, on behalf of Mazahir Alimohamed, inquired about the primary drivers of the company's operational efficiency and its sustainability, and also asked for details on the development milestones and strategy for the pipeline product XP-8121.

Answer

CFO Steven Pieper attributed operational efficiency to strong top-line growth, improving gross margins, and disciplined expense management, confirming the company expects to remain adjusted EBITDA positive. CEO John Shannon added that a comprehensive update on XP-8121's development pathway, regulatory strategy, and timelines will be provided at the Analyst and Investor Day on June 3.

Mazahir Alimohamed, on for Roanna Ruiz, asked about potential plans to further expand the Recorlev sales force in 2025 and inquired about the commercial synergies between the existing product portfolio and the future launch of XP-8121.

Answer

CFO Steven Pieper stated that while the company will remain opportunistic, there are no firm plans for another Recorlev sales force expansion in 2025. CEO John Shannon described XP-8121 as a "perfect fit" for the company's commercial infrastructure, highlighting its ability to leverage the existing endocrinology footprint, patient support services, and proven XeriSol technology platform.