AVDL

Avadel Pharmaceuticals presented at the 24th Annual Needham Virtual Healthcare Conference, at which the company provided an update on patient demand metrics that was in line with guidance from its full-year results announcement on March 3 and addressed questions related to the recent developments in United States tariff policy and the potential impact on the biopharmaceutical sector, including Avadel. "Specifically: In Q1 2025 patient demand metrics for LUMRYZ, Avadel's innovative narcolepsy medication with a market potential of a billion dollars in peak annual sales, all improved versus Q4 2024. These improvements include patient enrollments, patient starts, persistency rates, and net patients on therapy; REVITALYZ, the Company's Phase 3 pivotal trial studying LUMRYZ in Idiopathic Hypersomnia, is on track to complete enrollment in the second half of 2025; Avadel has initiated four patent infringement lawsuits against Jazz Pharmaceuticals since the beginning of 2025, alleging certain uses of Jazz's Xywav product, according to its corresponding labeling, infringe claims of five different Avadel patents; The Company expects to generate sustainable positive cash flow in 2025. Regarding the potential impact of possible changes in U.S. tariff policies, Avadel has developed a diversified supply chain over the past three years for LUMRYZ. The active pharmaceutical ingredient in LUMRYZ is sodium oxybate, which is manufactured by two contract development and manufacturing organizations located in the U.S. and approved by the U.S. Food and Drug Administration. Accordingly, the U.S. is the country of origin for all the API in LUMRYZ. The finished LUMRYZ commercial product is approved to be manufactured by one outsourced CDMO located in the U.S. and another in Europe. Additionally, all primary packaging of LUMRYZ is conducted in the U.S. In summary, these efforts have strengthened supply chain security and, if needed, the capability to manufacture LUMRYZ entirely in the U.S.," the company stated in a press release to coincide with the conference presentation.

Deutsche Bank analyst David Hoang initiated coverage of Avadel Pharmaceuticals with a Buy rating and $12 price target. The shares have declined meaningfully since the April 2024 highs and are trading at levels not seen since February 2023, prior to the commercial launch of Lumryz, the analyst tells investors in a research note. The firm sees potential upside from current levels following the 25% selloff in January post the preliminary results for Q4 and revised guidance for fiscal 2025, both of which came in below Street expectations due to an increased discontinuation rate for Lumryz. Deutsche says Avadel is presently oversold, with the market valuation reflecting a "near-worst case scenario" in which Lumryz peak sales plateau at $200M.