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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
Current Report Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported):
August 15, 2025
THERAVANCE
BIOPHARMA, INC.
(Exact Name of Registrant as Specified in its
Charter)
| Cayman Islands |
|
001-36033 |
|
98-1226628 |
| (State
or Other Jurisdiction of |
|
(Commission
File Number) |
|
(I.R.S.
Employer Identification |
| Incorporation) |
|
|
|
Number) |
c/o
Theravance Biopharma US, LLC
901
Gateway Boulevard
South
San Francisco, CA 94080
(650)
808-6000
(Addresses, including zip code, and telephone
numbers, including area code, of principal executive offices)
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 (see General
Instruction A.2. below):
¨
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
Share $0.00001 Par Value |
|
TBPH |
|
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 8.01 Other Events
On August 15, 2025, Theravance Biopharma
R&D IP, LLC, Theravance Biopharma US, LLC and Theravance Biopharma Ireland Limited, subsidiaries of the Registrant Theravance Biopharma, Inc.
(together, “Theravance”), and Mylan Ireland Limited and Viatris Specialty L.P. (together, “Mylan”), entered into
a Settlement Agreement (the “Settlement Agreement”) with Cipla Limited and Cipla USA, Inc. (“Cipla”) relating
to Theravance and Mylan’s YUPELRI® (revefenacin) inhalation solution. A Theravance entity owns and Mylan is the exclusive
sub-licensee of United States Patent Nos. 8,541,451; 9,765,028; 10,550,081; 11,008,289; 11,484,531; 11,691,948; 8,017,783; 9,249,099;
10,100,013; 11,649,209; 11,858,898, 12,048,692 and 12,285,417 (the “Patents-in-Suit”).
The Settlement Agreement resolves ongoing patent
litigation brought by Theravance and Mylan against Cipla pursuant to the Hatch-Waxman Act based on Cipla’s filing of an abbreviated
new drug application (“ANDA”) seeking approval to market a generic version of YUPELRI® (revefenacin) inhalation
solution prior to expiration of the Patents-in-Suit.
Under the Settlement Agreement, Theravance and
Mylan granted Cipla a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market Cipla’s
generic version of YUPELRI® (revefenacin) inhalation solution in the United States on or after the Licensed Launch Date
of April 23, 2039, subject to certain exceptions as is customary in these type of agreements.
As required by law, the settlement is subject
to review by the U.S. Department of Justice and the Federal Trade Commission.
The patent litigation previously disclosed by
the Company remains pending against one other ANDA filer: Mankind Pharma Ltd., along with certain affiliates.
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
THERAVANCE BIOPHARMA, INC. |
| |
|
|
| Date: August 20, 2025 |
By: |
/s/ Brett Grimaud |
| |
|
Brett Grimaud |
| |
|
General Counsel |
