Avadel Pharmaceuticals Plc Q3 FY2023 earnings call

• Launch progress: Over 1,000 patients enrolled in RYZUP, more than 400 patients initiated therapy during Q3, majority fully reimbursed. Expanded payer coverage with key health plans representing ~60% of commercial lives. Nearly 1,400 HCPs completed LUMRYZ REM certification. • Submission of a supplemental new drug application to the FDA for LUMRYZ in the pediatric narcolepsy population, expected approval in second half of 2024. • Progress on clinical planning for an IH multicenter randomized controlled trial. • Preclinical development of a potential no or low sodium once-in-time oxybate formulation.

In the third quarter, LUMRYZ generated $7 million in net revenue. This is the only product segment discussed, with no explicit revenue contribution percentage provided.

• Anticipates continuing launch execution and aiming for a meaningful share of the multibillion-dollar oxybate market. • Expects cash flow breakeven from operations with approximately 1,300 to 1,500 reimbursed patients on LUMRYZ. • Availability of a second tranche of $45 million royalty financing if $25 million quarterly net revenue is achieved by June 30, 2024 (not required to draw second tranche).

Q: Can you talk about the rate at which you're seeing enrollment in RYZUP and where these patients are coming from?

A: Richard Kim mentioned over 1,000 enrollments in RYZUP since August, with momentum continuing. Patients are sourced from all 3 target segments including switch patients from first-generation oxybate, discontinued first-generation oxybate patients, and oxybate-naive patients, with majority coming from first-generation oxybate.

Q: On the conversion rate, with 1,000 sign-ups in the quarter and 400 initiating therapy, what's the outlook for conversion rates going forward?

A: Gregory Divis stated that the 40% conversion rate isn't the right proxy early on, but the majority of patients in the system convert to therapy, and progress on payer coverage is helping with more conversions. Q4 is showing continued growth in enrollments and therapy initiations.

Q: Can you provide more detail on the process of patients passing through the RYZUP system and the percentage starting in RYZUP that initiate therapy?

A: Richard Kim explained the process involves enrollment, benefits investigation, and specialty pharmacy involvement. Over 1,000 enrollments with 400 initiating therapy, and most remaining 600 patients expected to convert. Time lines for fill rates are improving, and majority are expected to be on reimbursed product.