Avadel Pharmaceuticals plc Q1 FY2025 earnings call

• LUMRYZ saw accelerated patient adoption and expanded physician prescribing in Q1 2025, with improved launch metrics like patient enrollments, new patient starts, persistency rates, and net new patients on therapy.
• The Federal Circuit Court of Appeals ruled in Avadel's favor, allowing pursuit of LUMRYZ indications beyond narcolepsy, including idiopathic hypersomnia (IH).
• On January 1st, Avadel increased its sales force by 15%, expanded field reimbursement teams by doubling their size, and doubled the nursing support team, leading to positive patient demand growth, improved persistency, and net new patient adds.
• Enrollment in the Phase 3 REVITALYZ trial for LUMRYZ in idiopathic hypersomnia is on track, with expected completion of enrollment before the end of 2025, top-line data in early 2026, and an NDA filing thereafter.
• Litigation updates: Ongoing defense in the initial patent lawsuit, antitrust case against Jazz scheduled for jury trial in early November seeking over $1 billion, and offensive patent suits against Jazz for infringement of Avadel patents.

The primary product segment is LUMRYZ. In Q1 2025, net revenue was $52.5 million, a greater than 90% increase compared to Q1 2024 ($27.2 million). LUMRYZ had 2,800 patients on therapy at the end of Q1, representing 100% growth over the same period last year. Net new patient adds grew 50% in Q1 versus Q4 2024. Revenue contribution is predominantly from LUMRYZ's performance in the narcolepsy launch.

• Raised full-year 2025 net revenue guidance to $255 million to $265 million from $240 million to $260 million.
• Raised year-end patients on therapy guidance to 3,400 to 3,600 from 3,300 to 3,500.
• Expect Q2 2025 net revenue to be $60 million to $63 million with cash operating expenses in the range of $45 million to $50 million.

• Potential impact of industry-wide tariffs and policies on biotech, though Avadel has onshored manufacturing to mitigate this risk.
• Uncertainty around future generic competition and its potential impact on pricing and market share for LUMRYZ.

Q: About revised 2025 guidance and growth drivers A: Tom and Greg discussed that they expect sequential growth quarter-over-quarter for the remainder of the year and that drivers include sales team expansion, reimbursement team expansion, and persistency improvements Q: On IH patient footprint and appetite for additional assets A: Greg mentioned IH as an untapped market with LUMRYZ's unique clinical value proposition and Avadel's focus on LUMRYZ launch and lifecycle management, with potential for strategic asset additions Q: Average selling price and persistency A: Tom and Greg talked about average revenue per patient and tactics to improve persistency, including nurse team expansion Q: Federal court ruling implications A: Greg explained that the vacatur of the injunction allows Avadel to proceed with filing for FDA approval for IH and other indications Q: Competitor blocking and patient mix goals A: Greg addressed preparedness for potential injunctions and Tom emphasized focusing on all patient segments for growth Q: Offensive lawsuits and no-sodium formulation A: Greg discussed offensive patents against Jazz and ongoing work on no-sodium formulation with future updates expected Q: Orexin agonists and tariffs A: Greg and Tom talked about orexin agonists' market impact and Avadel's mitigation of tariff risks via domestic manufacturing