false
0001012477
0001012477
2025-09-15
2025-09-15
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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): September 15, 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 to 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. ¨
As previously disclosed, on May 12, 2021, Jazz Pharmaceuticals, Inc.
(“Jazz”) filed a formal complaint initiating a lawsuit in the United States District Court for the District of Delaware (the
“Court”) against Avadel CNS Pharmaceuticals, LLC (“Avadel CNS”), a wholly owned subsidiary of Avadel Pharmaceuticals
plc (the “Company” or “Avadel”). In the complaint, Jazz alleged LUMRYZ™ will infringe at least one claim
of certain patents. On August 27, 2024, the Court issued an opinion and order granting Jazz’s motion for an ongoing royalty on the
sale of LUMRYZ, pending additional briefing on the appropriate royalty rate, which closed on September 23, 2024. On September 15, 2025,
the Court issued an opinion and order requiring Avadel CNS to pay a future ongoing royalty of 3.85% on sales of LUMRYZ to Jazz through
expiration of Jazz’s U.S. Patent No. 11,147,782 (“the ’782 Patent”) on February 18, 2036. Avadel disagrees with
the underlying jury decision regarding the validity of the ‘782 Patent and plans to continue contesting that decision and any related
royalty obligation. Avadel has and will continue to accrue the royalty as well as recognize liability for same on the balance sheet.
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
plans to contest the jury decision regarding the validity of the ‘782 Patent and any related royalty obligation and expectations
for the Company to continue to accrue the royalty and recognize liability on the balance sheet. 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.
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.
| Date: September 17, 2025 |
AVADEL PHARMACEUTICALS PLC |
| |
|
|
| |
By: |
/s/ Jerad G. Seurer |
| |
|
Name: |
Jerad G. Seurer |
| |
|
Title: |
General Counsel & Corporate Secretary |
