Myriam Belghiti

Myriam Belghiti inquired about the potential impact of evolving international tariff policies on Soleno's business operations and launch activities.

Answer

CFO James MacKaness stated that the company does not anticipate any significant impact from current tariff policies. CEO Anish Bhatnagar elaborated that this is because both the drug substance and drug product are manufactured in the U.S., minimizing exposure to international trade tariffs.

Myriam Belghiti inquired about the potential impact of evolving international tariff policies on Soleno's business operations and launch.

Answer

Executive James MacKaness stated that the company does not foresee any significant impact from current tariff policies. Executive Anish Bhatnagar elaborated that this is because both the drug substance and drug product are manufactured by U.S.-based vendors.

Myriam Belghiti of LifeSci Capital asked for clarification on the recent Federal Circuit court decision, specifically what it means for the case to be remanded to the District Court and whether an injunction is still a possibility.

Answer

CEO Gregory Divis explained that the Federal Circuit vacated the injunction against seeking FDA approval because the District Court's original reasoning was deemed 'too speculative.' He stated that while the issue was sent back for reconsideration, the vacature provides Avadel with a clear and immediate pathway to file for and seek FDA approval for new indications like IH, which he described as a very important win for the company.

Myriam Belghiti of LifeSci Capital asked about Avadel's strategy for converting physicians who are new to prescribing oxybates into regular LUMRYZ prescribers. She also inquired if the company has an ideal patient mix goal for 2025 between switch and new-to-oxybate patients.

Answer

Executive Gregory Divis highlighted that over 200 physicians who had never prescribed an oxybate have now prescribed LUMRYZ, demonstrating market expansion. The expanded sales force is now targeting more physicians with similar profiles. Executive Thomas McHugh clarified that while Avadel has internal targets, the primary goal is to drive overall demand and improve all key metrics, rather than focusing on a single patient mix ratio, to ultimately grow revenue.