Avadel (NASDAQ: AVDL) inks global valiloxybate sleep-disorder drug deal

Rhea-AI Filing Summary

Avadel Pharmaceuticals entered an exclusive global license agreement with XWPharma for valiloxybate, a GABAB receptor agonist for sleep disorders including narcolepsy and idiopathic hypersomnia. The license covers worldwide rights excluding mainland China, Hong Kong and Macau.

Avadel has paid XWPharma an upfront $15 million and will pay an additional $5 million in the fourth quarter of 2025. XWPharma may receive up to $30 million in development milestones, up to $155 million in tiered sales milestones tied to annual net sales up to $750 million, and additional performance-based sales milestone payments equal to 10% of each sales milestone for annual net sales exceeding $750 million and up to $3.5 billion. The agreement also includes tiered royalties from high-single digit to mid-teens on annual net sales and a $10 million milestone after the first U.S. commercial sale for each indication beyond narcolepsy and idiopathic hypersomnia following FDA approval.

The agreement runs until expiration of the applicable royalty terms and includes customary provisions on termination, representations, covenants and indemnification, with Avadel able to terminate for convenience subject to a notice period.

Insights

Biopharma licensing analyst

Avadel secures a global sleep-disorder asset with modest upfront cost and significant back-end obligations.

Avadel Pharmaceuticals is expanding its sleep medicine portfolio through an exclusive global license for valiloxybate (excluding mainland China, Hong Kong and Macau). The economic structure is typical for late-stage or promising assets: an initial cash outlay of $15 million already paid plus an additional $5 million in Q4 2025, with the majority of consideration deferred into development and sales milestones.

Contingent payments include up to $30 million tied to development milestones and up to $155 million in tiered sales milestones linked to annual net sales up to $750 million. For annual net sales above $750 million and up to $3.5 billion, Avadel will pay XWPharma performance-based sales milestones equal to 10% of each such milestone, plus tiered royalties from high-single digit to mid-teens on net sales. This back-end weighting limits near-term cash drain but creates meaningful long-term obligations if the product is commercially successful.

The license term extends through the last royalty term per product and country, with standard termination rights, including Avadel’s ability to terminate for convenience subject to notice. Future company disclosures about clinical progress of valiloxybate, regulatory interactions, and any initial commercial performance in narcolepsy, idiopathic hypersomnia, or additional indications will be important to understand how quickly these contingent payments might be triggered.

8-K Event Classification

3 items: 1.01, 7.01, 9.01

3 items

Item 1.01 Entry into a Material Definitive Agreement Business

The company signed a significant contract such as a merger agreement, credit facility, or major partnership.

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or Section 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 29, 2025

AVADEL PHARMACEUTICALS PLC

(Exact name of registrant as specified in its charter)

Ireland	001-37977	98-1341933
(State or other jurisdiction	(Commission	(IRS Employer
of incorporation)	File Number)	Identification No.)

10 Earlsfort Terrace Dublin 2, Ireland, D02 T380	Not Applicable
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: +353 1 901-5201

Not applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Ordinary Shares, nominal value $0.01 per share	AVDL	The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 1.01. Entry into a Material Definitive Agreement.

On August 29, 2025, Avadel Pharmaceuticals plc (the “Company”) entered into an exclusive global license agreement (the “License Agreement”) with XWPharma Ltd. (“XWPharma”) for the development and commercialization of valiloxybate, a GABA_B receptor agonist, in all indications, including the treatment of sleep disorders, such as narcolepsy and idiopathic hypersomnia (“IH”). Under the terms of the License Agreement, XWPharma grants the Company an exclusive global license to develop, manufacture and commercialize valiloxybate worldwide, excluding mainland China, Hong Kong and Macau.

XWPharma received an upfront payment of $15 million to date and will receive an additional upfront payment of $5 million from the Company in the fourth quarter of 2025. XWPharma is eligible to receive milestone payments associated with certain development milestones of up to $30 million. The Company also agreed to pay XWPharma up to an aggregate of $155 million in performance-based tiered sales milestones for first achievement of annual net sales up to $750 million. For first achievement of annual net sales exceeding $750 million and up to $3.5 billion, the Company will pay XWPharma certain performance-based sales milestone payments equal to 10% of each of those sales milestones. In addition, the Company agreed to pay tiered royalties ranging from high-single digit to mid-teens, as a percentage of annual net sales of the licensed products, and also an additional $10 million milestone payment after the first commercial sale in the U.S. for each indication beyond narcolepsy and IH following the U.S. Food and Drug Administration’s approval for same.

Unless earlier terminated, the term of the License Agreement will continue until expiration of the last royalty term for the applicable product in the applicable country. The License Agreement is subject to customary termination provisions, including termination by a party for the other party’s uncured, material breach. Additionally, subject to a notice period, the Company may terminate the License Agreement for convenience.

The License Agreement also includes customary representations and warranties, covenants and indemnification obligations.

The foregoing summary of the terms of the License Agreement is qualified in its entirety by reference to the full text of the License Agreement, a copy of which the Company intends to file as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending September 30, 2025.

Item 7.01. Regulation FD Disclosure.

On September 3, 2025, the Company issued a press release entitled “Avadel Pharmaceuticals Strengthens Sleep Medicine Portfolio with Exclusive License of Valiloxybate from XWPharma Ltd.” A copy of the press release is furnished as Exhibit 99.1 to this Current Report on the Form 8-K.

The information in this Item 7.01, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Cautionary Disclosure Regarding Forward-Looking Statements

This Current Report on Form 8-K includes “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 relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects or other events. Such forward-looking statements include, but are not limited to, statements regarding the Company’s expectations about the License Agreement, including upfront, milestone and royalty payments. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions and the negatives thereof (if applicable).

The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, 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 expectations in the Company’s forward-looking statements include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission (SEC) on March 3, 2025, and subsequent SEC filings. Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

Item 9.01. Exhibits

(d) Exhibits

99.1	Press release issued by Avadel Pharmaceuticals plc on September 3, 2025.
104	Cover Page Interactive Data File (embedded with the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	AVADEL PHARMACEUTICALS PLC
	By:	/s/ Jerad G. Seurer
Date: September 3, 2025		Name:	Jerad G. Seurer
		Title:	General Counsel & Corporate Secretary

FAQ

What agreement did Avadel Pharmaceuticals (AVDL) enter into with XWPharma?

Avadel Pharmaceuticals entered into an exclusive global license agreement with XWPharma Ltd. for the development and commercialization of valiloxybate, a GABAB receptor agonist, in all indications, including narcolepsy and idiopathic hypersomnia. The license covers worldwide rights except for mainland China, Hong Kong and Macau.

How much is Avadel paying XWPharma upfront for the valiloxybate license?

XWPharma has received an upfront payment of $15 million from Avadel to date, and Avadel will pay an additional upfront $5 million in the fourth quarter of 2025.

What milestone and royalty payments could XWPharma receive under the Avadel license deal?

XWPharma is eligible for up to $30 million in development milestones and up to $155 million in performance-based tiered sales milestones tied to first achievement of annual net sales up to $750 million. For first achievement of annual net sales exceeding $750 million and up to $3.5 billion, Avadel will pay sales milestone amounts equal to 10% of each such sales milestone. In addition, XWPharma will receive tiered royalties from high-single digit to mid-teens on annual net sales and a $10 million milestone after the first U.S. commercial sale for each indication beyond narcolepsy and idiopathic hypersomnia following FDA approval.

How long does the license agreement between Avadel (AVDL) and XWPharma last?

Unless terminated earlier, the license agreement will continue until the expiration of the last royalty term for the applicable product in the applicable country, providing a long-duration commercial framework for valiloxybate.

Can Avadel terminate the valiloxybate license agreement with XWPharma?

Yes. The agreement includes customary termination provisions, such as termination by either party for the other party’s uncured, material breach. In addition, subject to a notice period, Avadel may terminate the agreement for convenience.

What disclosure did Avadel make under Regulation FD about the valiloxybate license?

Avadel stated that on September 3, 2025 it issued a press release titled “Avadel Pharmaceuticals Strengthens Sleep Medicine Portfolio with Exclusive License of Valiloxybate from XWPharma Ltd.” This press release was furnished as Exhibit 99.1 and, along with the related Item 7.01 information, is treated as furnished rather than filed for purposes of the Exchange Act.