Avadel Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2024 Financial Results

In This Article:

Avadel Pharmaceuticals plc
Avadel Pharmaceuticals plc

-- Generated $50.0 million in net revenue from sales of LUMRYZ™ --

--2,300 patients on LUMRYZ as of September 30th, including 700 patients that initiated therapy in the quarter --

-- Received FDA approval for LUMRYZ for the treatment of cataplexy or EDS in patients 7 years and older with narcolepsy, granted ODE through October 16, 2031 --

-- LUMRYZ approval upheld by court in suit brought by Jazz regarding FDA’s determination that LUMRYZ is clinically superior to twice-nightly oxybate products --

-- Progressed Phase 3 REVITALYZ™ study evaluating efficacy and safety of LUMRYZ in IH --

-- Management to host a conference call today at 8:30 a.m. ET --

DUBLIN, Ireland, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a corporate update and announced its financial results for the quarter ended September 30, 2024.

“Over a year ago, we set out on our mission to transform the lives of those living with narcolepsy, including expanding the oxybate market through the introduction of LUMRYZ. This quarter, we are proud to see that expansion come to fruition and continue to be encouraged by patient uptake and quarter-over-quarter growth of LUMRYZ. In parallel to our launch in adults with narcolepsy, we are expanding into additional patient populations, starting with the recent FDA approval of LUMRYZ for the treatment of cataplexy or EDS in patients 7 years and older with narcolepsy, significantly alleviating the burden on patients and their caregivers of waking up in the middle of the night to administer treatment,” stated Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. “We are also pleased with the recent court ruling affirming FDA’s determination that LUMRYZ, dosed once at bedtime, demonstrates clinical superiority to twice-nightly oxybates, which mitigates an important legal and business risk for the company. With our Phase 3 pivotal trial in IH ongoing, our continued execution of the LUMRYZ launch including our expansion of LUMRYZ into pediatric narcolepsy, we are closing in our business objectives of being a leader in the sleep field and fulfilling the promise of LUMRYZ for all stakeholders.”

Third Quarter and Recent Company Highlights

LUMRYZ Commercial Updates:

  • Generated $50.0 million of net product revenue from sales of LUMRYZ in the third quarter of 2024.

  • As of September 30, there were 2,300 patients on LUMRYZ compared to 1,900 patients on LUMRYZ at June 30.

    • In the third quarter, generated consistent patient demand for LUMRYZ with 700 patients initiating therapy.

    • Observed continuing growth in demand from patients who are new to oxybate – these patients represent the fastest growing patient segment for LUMRYZ.

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