Release Date: November 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Avadel Pharmaceuticals PLC (AVDL, Financial) reported consistent patient growth for LUMRYZ, with 2,300 active patients and 700 new initiations in Q3, resulting in $50 million in net revenue.
- The company received FDA approval and orphan drug exclusivity for LUMRYZ in pediatric patients, expanding its treatment reach.
- LUMRYZ is showing strong uptake among new to oxybate patients, indicating potential market expansion.
- Avadel Pharmaceuticals PLC (AVDL) secured a favorable court ruling affirming FDA's approval and clinical superiority decision for LUMRYZ.
- The company is making strategic investments to improve patient persistency and support, including doubling nurse care navigators and expanding the sales team.
Negative Points
- New to oxybate patients are showing lower persistency rates compared to switch patients, posing a challenge for long-term patient retention.
- The company anticipates potential seasonal impacts in Q4, including fewer shipping days and higher gross-to-net deductions.
- There is ongoing patent litigation with Jazz Pharmaceuticals, which could impact future financials.
- The company is facing challenges in educating new to oxybate patients about the time required to find their optimal dose, leading to higher discontinuation rates.
- Despite strong commercial coverage, there are concerns about insurance changes and reauthorization processes affecting patient continuity.
Q & A Highlights
Q: Can you talk about the patient trends you're seeing so far, including the month of October and the parts of November? And your confidence around a strong Q4 growth trajectory despite some potential seasonality and higher gross to net deductions? Are you still confident you will continue gaining share from former oxybate users as well as existing switches, not just the naive oxybate group?
A: Richard Kim, Chief Commercial Officer: We continue to see strong demand for LUMRYZ this quarter. The interest remains very strong, and switch patients will continue to be a core part of our business. The value proposition for once-at-bedtime dosing is compelling, and we expect to maintain our share from switch patients.
Q: In terms of the new to oxybate, can you help us understand with the AGs and going forward, how that works in terms of insurance? Is there a step through to deal with this in this new stage of the launch? How much are you going to grow the sales force?
A: Richard Kim, Chief Commercial Officer: We have secured 85% commercial coverage, so it's rare that an AG is a step for LUMRYZ. We are adding over 10% to our field force to increase reach and frequency to moderate and low oxybate users, as well as targeting prescribers who have never used oxybate before.
Q: Can you talk about why new patients are discontinuing more? Is there any difference in tolerability for these patients versus long-time users of twice-nightly? Is the support from RYZUP more important long-term or just for expectation setting upfront?
A: Richard Kim, Chief Commercial Officer: New to oxybate patients often don't know what to expect, which can lead to higher discontinuation. Our nurse care navigators play a critical role in managing expectations and supporting patients throughout their treatment journey. We are investing in more frequent support to improve persistency.
Q: Regarding reimbursement in general, have there been any material changes going into 2025, both in terms of standalone coverage and relative formulary positioning versus competition? How much of a tailwind should Medicare coverage be in 2025 and beyond?
A: Richard Kim, Chief Commercial Officer: We expect to maintain strong coverage into 2025 and anticipate picking up more Medicare lives. We are in a strong position regarding overall coverage.
Q: Can you talk about what percent of new patient starts are coming from completely new patients versus switch patients? In terms of switch patients, are they coming from high sodium, AG, or low sodium oxybate? How has the growth rate of the overall oxybate market evolved since the launch of LUMRYZ?
A: Gregory Divis, CEO: The largest portion of patient starts in Q3 were switch patients, with new to oxybate patients closing the gap. Most switch patients are coming from mixed salt oxybate. We see signs that the overall narcolepsy market is growing, with new prescribers and patients who previously discontinued oxybate now starting LUMRYZ.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
