Avadel Pharmaceuticals Enters Material Definitive Agreement

TL;DR

AVDL signed a big deal, details TBD.

AI Summary

On August 29, 2025, Avadel Pharmaceuticals plc entered into a material definitive agreement. The company also provided a Regulation FD disclosure and filed financial statements and exhibits. Specific details of the agreement and financial information were not provided in this excerpt.

Why It Matters

This filing indicates a significant new contract or partnership for Avadel Pharmaceuticals, which could impact its future business operations and financial performance.

Risk Assessment

Risk Level: medium — The filing indicates a material definitive agreement, which often involves significant financial commitments or strategic shifts, but the lack of specific details introduces uncertainty.

Key Players & Entities

• AVADEL PHARMACEUTICALS PLC (company) — Filer
• August 29, 2025 (date) — Date of earliest event reported

FAQ

Key Financial Figures

• $0.01 — stered Ordinary Shares, nominal value $0.01 per share AVDL The Nasdaq Global Ma
• $15 million — XWPharma received an upfront payment of $15 million to date and will receive an additional
• $5 million — eceive an additional upfront payment of $5 million from the Company in the fourth quarter
• $30 million — certain development milestones of up to $30 million. The Company also agreed to pay XWPharm
• $155 million — d to pay XWPharma up to an aggregate of $155 million in performance-based tiered sales miles
• $750 million — t achievement of annual net sales up to $750 million. For first achievement of annual net sa
• $3.5 b — sales exceeding $750 million and up to $3.5 billion, the Company will pay XWPharma ce
• $10 million — censed products, and also an additional $10 million milestone payment after the first comme

Filing Documents

• tm2525099d1_8k.htm (8-K) — 33KB
• tm2525099d1_ex99-1.htm (EX-99.1) — 33KB
• tm2525099d1_ex99-1img001.jpg (GRAPHIC) — 7KB
• 0001104659-25-087076.txt ( ) — 248KB
• avdl-20250829.xsd (EX-101.SCH) — 3KB
• avdl-20250829_lab.xml (EX-101.LAB) — 33KB
• avdl-20250829_pre.xml (EX-101.PRE) — 22KB
• tm2525099d1_8k_htm.xml (XML) — 3KB

01. Entry into a Material Definitive Agreement

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 par

01. Regulation FD Disclosure

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 ris

01. Exhibits

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

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

View Full Filing

View this 8-K filing on SEC EDGAR