Full Press Release Details
For Investors: Sandy Coombs +1
For Media: Katie Joyce +1
Alkermes plc Completes Acquisition of Avadel
Pharmaceuticals plc, Accelerating Entry Into Sleep Medicine Market
- Augments Alkermes' Revenue Growth
Profile and Diversifies Commercial Portfolio with New High Potential Growth Product, LUMRYZ (Sodium Oxybate) for Extended-Release
- Expected to be Accretive in 2026 -
- Positions the Combined Organization to
Accelerate Innovation and Leadership in Development of Treatments for Sleep Disorders and Other Neurological Disorders -
DUBLIN - (Business Wire) - Feb. 12, 2026 -- Alkermes
plc (Nasdaq: ALKS) ("Alkermes") and Avadel Pharmaceuticals plc (Nasdaq: AVDL) ("Avadel") today announced Alkermes'
completion of its acquisition of Avadel, a commercial-stage biopharmaceutical company. The acquisition adds Avadel's FDA-approved
product, LUMRYZ , to Alkermes' commercial portfolio, and provides Alkermes with a commercial organization experienced in this
disease state. This strategic move accelerates Alkermes' entry into the sleep medicine market and enhances its ability to unlock
the full potential of its late-stage development pipeline focused on central disorders of hypersomnolence.
The transaction was completed pursuant to an Irish High Court sanctioned
scheme of arrangement (the "Scheme") under Chapter 1 of Part 9 of the Companies Act 2014 of Ireland. LUMRYZ (sodium oxybate) for extended-release oral suspension is approved for the treatment of cataplexy or excessive
daytime sleepiness in patients seven years of age and older with narcolepsy.
"With the close of this acquisition, Alkermes achieved an important
milestone in the continued advancement of our strategy, accelerating our entry into the commercial sleep medicine market at a pivotal
moment as we work to initiate the planned phase 3 program for alixorexton in narcolepsy this quarter. Avadel's commercial and R&D
portfolio, established commercial infrastructure, and talented team strengthen our organization and expand our capabilities in this important
therapeutic area. Supported by our strong balance sheet, this all-cash acquisition is expected to enhance our revenue growth profile and
underscores our ongoing commitment to creating long-term value for shareholders," said Richard Pops, Chief Executive Officer of
The transaction is expected to be accretive in 2026 and represents
a compelling financial and strategic opportunity, leveraging Alkermes' existing commercial expertise and operational infrastructure
and adding new capabilities in rare disease. Avadel is a recognized innovator in the sleep medicine space, committed to addressing significant
unmet needs for patients.
Since launching LUMRYZ in 2023, Avadel has successfully built and scaled
a commercial organization that has driven strong demand. With an estimated population of >50,000 oxybate-eligible narcolepsy patients
in the United States, LUMRYZ has significant opportunity for growth ahead. The acquisition also includes valiloxybate, Avadel's in-licensed
salt-free, once-at-bedtime oxybate candidate in phase 1 clinical development.
To finance the acquisition, Alkermes will use approximately $750 million
of cash from its balance sheet and borrowed a total of $1.525 billion in term loans that are due in 2031. The company expects to pay down
the debt quickly with cash flows from the business.
Alkermes will provide its 2026 financial expectations for the combined
organization on Feb. 25, 2026 as part of its financial results announcement for the quarter and year ended Dec. 31, 2025. Alkermes'
financial expectations for 2026 will include certain expenses related to the transaction, including:
The acquisition was approved by Avadel shareholders at a scheme meeting
of shareholders and at an extraordinary general meeting of shareholders, each held on Jan. 12, 2026. The Irish High Court sanctioned
the Scheme on Feb. 10, 2026. On Feb. 12, 2026 (the "Effective Date"), the Scheme and the acquisition became effective
upon delivery of the court order of the Irish High Court to the Irish Companies Registration Office. Prior to the opening of trading on
Feb. 12, 2026, all of Avadel's shares will cease trading on the Nasdaq Global Market ("Nasdaq"), and Avadel intends
to promptly cause such shares to be delisted from Nasdaq and deregistered under the Securities Exchange Act of 1934, as amended.
Payment of the Cash Consideration to the Scheme Shareholders pursuant
to the Scheme is being commenced by Alkermes today, Feb. 12, 2026. The Rights Agent will record the Scheme Shareholders as the owners
of the CVR Consideration in the CVR Register in accordance with the terms of the CVR Agreement dated as of today, Feb. 12, 2026.
Except as otherwise defined herein, capitalized terms used but not
defined in this announcement have the same meanings as given to them in the definitive proxy statement filed by Avadel with the U.S. Securities
and Exchange Commission ("SEC") on Dec. 3, 2025, which also constitutes a scheme circular under Irish law.
Alkermes plc (Nasdaq: ALKS), a mid-cap growth and value equity, is
a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio
of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy.
Alkermes' pipeline includes late-stage clinical candidates in development for narcolepsy and idiopathic hypersomnia, and orexin
2 receptor agonists in early clinical development for other neurological disorders, including attention-deficit hyperactivity disorder
(ADHD) and fatigue associated with multiple sclerosis and Parkinson's disease. Headquartered in Ireland, Alkermes also has
a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more
information, please visit Alkermes' website at www.alkermes.com.
About LUMRYZ (sodium oxybate) for extended-release oral
LUMRYZ is an extended-release sodium oxybate medication
approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness
(EDS) in adults with narcolepsy. On Oct. 16, 2024, LUMRYZ was additionally approved as a once-at-bedtime treatment for cataplexy
or EDS in pediatric patients seven years of age and older with narcolepsy.
The LUMRYZ prescribing information includes Boxed Warnings for central
nervous system (CNS) depression and abuse and misuse. LUMRYZ is a CNS depressant. Clinically significant respiratory depression and obtundation
may occur in patients treated with LUMRYZ at recommended doses. Many patients who received LUMRYZ during clinical trials in narcolepsy
were receiving CNS stimulants. LUMRYZ is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone
or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreased
consciousness, coma, and death. Because of the risks of CNS depression and abuse and misuse, LUMRYZ is available only through a restricted
program under a Risk Evaluation and Mitigation Strategy (REMS) called the LUMRYZ REMS. Please see full Prescribing Information
for additional safety information including BOXED Warnings. Further information about the REMS is available at www.LUMRYZREMS.com or
by calling 1-877-453-1029.
Note Regarding Forward-Looking Statements
Certain statements set forth in this announcement constitute
"forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended,
including, but not limited to, statements concerning: Alkermes' expectations concerning the combined organization's
future financial and operating performance, business plans or prospects, including expected transaction costs and accounting, the
company's anticipated growth profile, financial expectations and plans for LUMRYZ and expected timelines for paying down the
company's debt; and Alkermes' expectations regarding development plans, activities and timelines for, and the potential
therapeutic and commercial value of, the combined organization's portfolio of development candidates. Alkermes cautions that
forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are
necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those
expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties
include, among others: the businesses of Alkermes and Avadel may not be effectively integrated and the expected benefits and value
of the acquisition may not be achieved; there may be unknown or inestimable liabilities, potential litigation and transaction costs
associated with the acquisition; whether any general economic, political, market and business conditions, or future exchange and
interest rates, changes in tax laws, regulations, rates and policies, may have a negative impact on the combined organization
following consummation of the acquisition; the completion of the acquisition could result in disruption to the business and make it
more difficult to maintain business and operational relationships of Alkermes and Avadel, including the ability of Alkermes to
retain highly qualified personnel; the company may not be able to pay down its debt on expected timelines or at all; clinical
development activities may not be initiated or completed on expected timelines or at all; the results of development activities may
not be positive, or predictive of future results from such activities, results of future development activities or real-world
results; Alkermes' products or product candidates could be shown to be ineffective or unsafe; the FDA or regulatory
authorities outside the U.S. may not agree with Alkermes' regulatory approval strategies or may make adverse
decisions regarding its products; Alkermes may not be able to continue to successfully commercialize its products or support revenue
growth from such products; there may be a reduction in payment rate or reimbursement for Alkermes' products or an increase in
related financial obligations to government payers; Alkermes' products may prove difficult to manufacture, be precluded from
commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of
misuse; and those risks and uncertainties described under the heading "Risk Factors" in Alkermes' Annual Report on
Form 10-K for the year ended Dec. 31, 2024 and in subsequent filings made by Alkermes with the SEC, which are