Avadel Pharmaceuticals Provides Corporate Update and Reports on Fourth Quarter and Full Year 2022 Financial Results (2023)

• LUMRYZ™ NDA amendment was submitted March 1 to seek final FDA approval
• Receive FDA approval to import LUMRYZ prior to final approval decision; Reduces the time between possible approval and product availability
• Secure $200M in capital to fund the launch of LUMRYZ and extend the $96.2M maturity of the convertible bonds through 2027
• Launch preparations on track to support commercial launch of LUMRYZ in the US
• Management will hold a conference call today at 8:30 am ET

DUBLIN, Ireland, March 30, 2023 (GLOBE NEWSWIRE) --Avadel Pharmaceuticals plc(Nasdaq: AVDL), a biopharmaceutical company focused on transforming life-enhancing medicines, today released a company update and reported its financial results for the fourth quarter ended December 31, 2022.

“2023 is shaping up to be a significant year for Avadel. I am proud of everything our team has recently accomplished, including submitting an amendment to the FDA seeking final approval for LUMRYZ and securing FDA approval for our PLAIR filing, which allows us to allow the product to be imported into the United States. before a final regulatory decision. Together, these milestones bring us closer to commercializing potential for LUMRYZ," said Greg Divis, CEO of Avadel Pharmaceuticals. , as we enter a crucial phase of growth for the company. I would like to thank everyone involved, including patients, healthcare professionals and our investors, for their strong support throughout this process. We look forward to continuing to make progress in executing our plan strategy to bring LUMRYZ into the $3+ billion oxybate market.”

Fourth quarter and recent company history highlights

• Recently, Avadel has made significant progress in moving LUMRYZ toward a final regulatory decision and preparing for commercial launch in the US.
  • On the 1st of March^stthe company has filed with the US Food and Drug Administration (“FDA”) has introduced a minor amendment requesting final approval of LUMRYZ for the treatment of cataplexy, or excessive daytime sleepiness (EDS), in adults with narcolepsy.
    • The company filed the amendment shortly after Jazz Pharmaceuticals filed with the FDA to remove the REMS patent from the FDA's Orange Book in response to the United States Court of Appeals for the Federal Circuit panel's unanimous 3-to-0 decision dated of March 24, 2019 February, revoking the previous U.S. District Court for the Federal District of Delaware.
  • The FDA has approved Avadel's Significant Pre-Launch Activity Requests (PLAIR) for LUMRYZ. Through PLAIR, Avadel is able to import provisionally approved LUMRYZ into the United States prior to a final approval decision.
    • Importing LUMRYZ before possible final approval allows Avadel to shorten the time between final FDA approval and commercial availability for people with narcolepsy.
  • Commercial compound advances ahead of possible launch of LUMRYZ in the US, including completion of specialty pharmacy network, patient care center and LUMRYZ REMS program.
  • Ongoing collaboration with key stakeholders, including sleep specialists and payers, as we expand our customer-facing teams, including medical science liaisons, directors of sales, area executives and on-site reimbursement specialists.
• Successfully executed several strategic financing activities and secured $200 million in capital to fund the launch of LUMRYZ.
  • Entered into a royalty agreement with RTW Investments (RTW) of up to US$75 million to support the potential commercialization of LUMRYZ.
    • Under the terms of the license agreement, RTW will provide Avadel with up to $75 million in synthetic royalty core funding in exchange for staggered cash payments based on LUMRYZ's US net sales.
  • Completed an equity offering with gross proceeds of $125 million before deducting subscription discounts, commissions, and estimated offering expenses.
  • Exchange of US$96.2 million in convertible debentures with a new maturity date of April 3, 2027.
• Announced several sets of data in support of the LUMRYZ product profile, including:
  • Release of real-world data describing the risk of accidental dosing errors with twice-daily immediate-release oxybate, including an analysis of post-marketing safety surveillance data from the FDA Adverse Event Reporting System (FAERS).
  • Several presentations at the American Neurological Association (ANA) Annual Meeting in October describing the demographics and comorbidities of patients with narcolepsy and positive data from the completed Phase 3 REST-ON trial, as well as patient and physician preference for one time evening versus twice nightly dosing has been confirmed.
  • Poster presented at the October meeting of the American College of Chest Physicians (CHEST) with updated patient preference results and overnight adverse event questionnaires from the RESTORE study, in which 94% of patients switching from twice-harmful oxybates reported a preferred at bedtime, as well as confirmation of dose-related challenges in the middle of the night.
• Expanded patent exclusivity for LUMRYZ with 5 additional US patents for a current total of 13 patents providing patent protection listed in the Orange Book through early 2042.

Fourth Quarter Results Summary

R&D spend was $6.2 million for the quarter ended December 31, 2022, compared to $2.1 million for the same period in 2021. The increase for the period was primarily due to an increase in ingredient purchases active pharmaceutical used in the manufacture of LUMRYZ.

Selling, general and administrative expenses were $17.0 million for the quarter ended December 31, 2022, compared to $21.0 million for the same period in 2021. The year-on-year decline is a result of several factors including lower marketing and trading spend. These reductions were partially offset by higher legal expenses.

Net loss for the quarter ended December 31, 2022 was $27.5 million, or ($0.44) per diluted share, compared to a net loss of $22.3 million, or ($ $0.38) per diluted share for the same period in 2021.

Cash, cash equivalents and marketable securities were $96.5 million as of December 31, 2022. The Company has extended the maturity of $96.2 million of its convertible debentures through April 2027 and $21.2 million will mature in October 2023.

phone conference

Avadel will host a conference call and live audio webcast today at 8:30 am ET to discuss fourth quarter and full year 2022 financial results and provide a corporate update. To access the live conference call, registerHere. A live audio webcast of the conference call and accompanying slideshow will also be available on the Investor Relations section of the Company's website,www.avadel.com. A replay of the webcast will be archived on the Avadel website for 90 days after the event.

About LUMRYZ

LUMRYZ is an experimental formulation of sodium oxybate, utilizing our proprietary drug delivery technology, designed for single bedtime dosing for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

In March 2020, Avadel completed the REST-ON trial, a pivotal, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of LUMRYZ in patients with narcolepsy. Among the three co-primary endpoints, LUMRYZ demonstrated statistically significant and clinically significant results on EDS, physician's global assessment of patient functioning, and reduction in cataplexy attacks compared to placebo for all three cases studied.

In January 2018, the U.S. Food and Drug Administration (FDA) granted LUMRYZ orphan drug designation for the treatment of narcolepsy based on the plausible hypothesis that LUMRYZ may be safer than the twice-nightly formulation of sodium oxybate, which has already been approved by the FDA for effects associated with the dosage schedule of this product. LUMRYZ is currently under FDA review.

On July 18, 2022, the FDA provisionally approved the LUMRYZ NDA for the treatment of cataplexy, or EDS, in adults with narcolepsy. Avadel filed a minor amendment to the FDA on March 1, 2023, requesting final approval of LUMRYZ. This minor amendment was filed shortly after the removal of the REMS patent from the FDA's Orange Book by Jazz Pharmaceuticals in response to the February 24 unanimous 3-0 panel decision of the United States Court of Appeals for the Federal Circuit, in which the United States United District Court for the Federal District of Delaware upheld the earlier judgment, ordering Jazz to do so.

Avadel is currently evaluating the long-term safety and tolerability of LUMRYZ in the RESTORE open-label clinical trial. For more information visit:www.restore-narcolepsy-study.com.

Über Avadel Pharmaceuticals plc

Avadel Pharmaceuticals plc (Nasdaq:AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach involves applying innovative drug development solutions that address the challenges patients face with current treatment options. Our current lead drug candidate, LUMRYZ, is an experimental formulation of sodium oxybate utilizing our proprietary drug delivery technology, designed for single dose dosing at bedtime for the treatment of cataplexy or EDS in adults with narcolepsy. For more information please visitwww.avadel.com.

Cautionary Note About Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements address our future expectations, beliefs, plans, strategies, goals, results , conditions, financial performance, prospects or other events. Such forward-looking statements include, but are not limited to, expectations regarding the potential final FDA approval of LUMRYZ, including timing, the company's preparation for the commercial launch of LUMRYZ, the potential time savings between potential final approval of FDA and the LUMRYZ commercial launch, attributable to the FDA approval of PLAIR; market acceptance of LUMRYZ (if approved), total addressable market size for sodium oxybate, anticipated use of Company capital, including proceeds from recent financing; the expected life of the Company's convertible bonds; and the anticipated duration and scope of the patent's exclusivity to LUMRYZ. In some cases, forward-looking statements are identified by the use of words such as "will", "may", "could", "believe", "potential", "could", "would", "purpose", "expect", "after". look ahead", "on schedule", "guidance", "anticipate", "estimate", "project", "investigation", "pipeline", "initiate", "next steps" and similar expressions and their negatives ( if applicable).

The Company's forward-looking statements are based on estimates and assumptions based on our knowledge of our business and operations and which we believe are reasonable. However, the Company's business and operations are subject to significant risks and, therefore, there can be no assurance that actual results and the results of the Company's business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from those anticipated in the Company's forward-looking statements include the risks and uncertainties discussed in the "Risk Factors" section of Part I, Item 1A of the Company's Annual Report on Form 10-K to the year ended December 31, 2022, filed with the Securities and Exchange Commission (SEC) on March 29, 2023 and subsequent filings with the SEC.

Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Therefore, you should not place undue reliance on forward-looking statements. The Company undertakes no obligation to publicly update or revise any of our forward-looking statements, except as required by law.

Investor contact:
Courtney Turiano
Stern Investor Relations, Inc.
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(212) 698-8687

Media contact:
Gabriella Greig
real chemistry
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(203) 249-2688