Form 8-K
8-K — Theravance Biopharma, Inc.
Accession: 0001104659-26-036870
Filed: 2026-03-30
Period: 2026-03-27
CIK: 0001583107
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Other Events
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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):
March 27, 2026
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
(Address, 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 March 27, 2026, 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 Mankind Pharma Ltd. and Lifestar Pharma LLC (“Mankind”)
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. 11,484,531, 12,048,692 and 12,285,417 (the “Patents-in-Suit”).
The Settlement Agreement resolves patent litigation
brought by Theravance and Mylan against Mankind pursuant to the Hatch-Waxman Act based on Mankind’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 Mankind a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market Mankind’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 and other provisions customary for agreements of this type.
As required by law, the settlement is subject
to review by the U.S. Department of Justice and the Federal Trade Commission.
With this Settlement Agreement, all pending Hatch-Waxman
litigation relating to YUPELRI® (revefenacin) inhalation solution has been resolved.
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: March 30, 2026
By:
/s/ Brett Grimaud
Brett Grimaud
General Counsel
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