- Definitive agreement to result in one-time $225 million cash payment
- Theravance Biopharma retains rights to up to
$150 million in milestones from
Royalty Pharma on Trelegy Ellipta net sales in 2025 and 2026,
requiring minimal to no growth over 2024 actuals to be
achieved
- $225 million from royalty
transaction announced today, in addition to
the $1.1 billion upfront
received in 2022, and up to $200
million in milestones (of which $50
million was received in 2025), brings total potential
lifetime value from Trelegy Ellipta monetization
efforts to $1.525 billion
- First outcome from Strategic Review Committee's ongoing
efforts to maximize shareholder value; Board
remains committed to returning excess capital to
shareholders
DUBLIN,
June 2,
2025 /PRNewswire/ -- Theravance Biopharma, Inc.
("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today
announced that it has entered into a definitive agreement to sell
its remaining royalty interest in net sales of Trelegy
Ellipta ("Trelegy") to GSK (NYSE: GSK) for $225 million in cash.
"Through this agreement with GSK to monetize
our outer-year Trelegy royalties, we are translating our
long-standing confidence in Trelegy's sustained success into
immediate value for Theravance Biopharma
shareholders," said Rick E Winningham, CEO of Theravance
Biopharma. "Our initial 2022 sale of Trelegy royalty interests
generated $1.1 billion in upfront
cash, strengthening our balance sheet and enabling us to return
significant capital to shareholders. Our decision to retain future
Trelegy royalties and potential milestones in the 2022 transaction
reflected our confidence in the product's enduring value and
commitment to maximize the value of the royalty interest for our
shareholders. This latest agreement with GSK, resulting from the
ongoing work of the Strategic Review Committee and the company's
senior management, further validates this strategy, and comes
alongside our continued work to grow YUPELRI and advance
ampreloxetine towards potential regulatory approval and
launch."
Theravance Biopharma's economic interest in
Trelegy originates from a 2002 collaboration agreement with
GSK, in which Theravance Biopharma's predecessor pooled with GSK
its long-acting beta agonist (LABA) assets in exchange for
milestones and royalties on LABA-containing combination products
subsequently developed and commercialized by GSK, including
Trelegy. In 2022, Theravance Biopharma sold its economic
interest in the Trelegy royalties to Royalty Pharma in
exchange for $1.1 billion upfront and
potential sales related milestone payments of up to $250 million in the aggregate, while retaining
the right to receive 85% of Trelegy royalties for sales of
Trelegy from and after 2029 (ex-U.S.) and 2031 (U.S.)
("Outer Year Royalties").
Under the terms of the agreement announced today,
Theravance Biopharma will receive $225
million in cash for the sale of the Outer Year Royalties.
The Company retains its right to receive up to $150 million in remaining Trelegy sales
related milestones in 2025 and 2026 from Royalty Pharma:
- $50 million if FY 2025
global net sales reach ~$3.41 billion
(approx. -1% vs. 2024)
- $100 million if FY 2026
global net sales reach ~$3.51 billion
(approx. +2% vs. 2024)
Theravance Biopharma's financial guidance for
2025 remains unchanged.
This transaction represents the first outcome of
the ongoing efforts of the Strategic Review Committee (the
"Committee") of the Board of Directors. Theravance Biopharma
announced on November 12, 2024, that
the Board of Directors had formed the Committee, composed entirely
of independent directors, to assess all strategic alternatives
available to the Company. The Company remains focused on
disciplined capital allocation and returning excess cash to
shareholders. The Committee will continue to evaluate a range of
alternatives to further enhance shareholder value, though there can
be no assurance that additional transactions will occur.
Advisors
Lazard acted as exclusive financial advisor, and
Skadden, Arps, Slate, Meagher & Flom LLP acted as legal advisor
to Theravance Biopharma.
About Theravance Biopharma
Theravance Biopharma, Inc.'s focus is to deliver
Medicines that Make a Difference® in people's
lives. In pursuit of its purpose, Theravance Biopharma leverages
decades of expertise, which has led to the development of
FDA-approved YUPELRI® (revefenacin) inhalation solution
indicated for the maintenance treatment of patients with chronic
obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage
investigational once-daily norepinephrine reuptake inhibitor in
development for symptomatic neurogenic orthostatic hypotension
(nOH) in patients with Multiple System Atrophy (MSA), has the
potential to be a first in class therapy effective in treating a
constellation of cardinal symptoms in MSA patients. The Company is
committed to creating/driving shareholder value.
For more information, please visit
www.theravance.com.
THERAVANCE BIOPHARMA®,
THERAVANCE® and the Cross/Star logo are registered
trademarks of the Theravance Biopharma group of companies
(in the U.S. and certain other countries).
YUPELRI® is a registered
trademark of Mylan Specialty L.P., a Viatris company.
Trademarks, trade names or service marks of other companies
appearing in this press release are the property of their
respective owners.
TRELEGY and ELLIPTA are registered trademarks of
the GSK group of companies.
Forward-Looking Statements
This press release will contain certain
"forward-looking" statements as that term is defined in the Private
Securities Litigation Reform Act of 1995 regarding, among other
things, statements relating to goals, plans, objectives,
expectations, and future events. Theravance Biopharma intends such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E
of the Securities Exchange Act of 1934, as amended, and the Private
Securities Litigation Reform Act of 1995. Examples of such
statements include statements relating to: the Company's
expectations regarding its future profitability, expenses and uses
of cash, the Company's goals, designs, strategies, plans,
potential, and objectives, future growth of YUPELRI sales, future
milestone and royalty payments, the ability to provide value to
shareholders, the Company's regulatory strategies and timing of
clinical studies, potential or possible safety, efficacy or
differentiation of our investigational therapy, ongoing
review activities of the Strategic Review Committee and contingent
payments due to the Company from the sale of the Company's
Trelegy royalty interests to Royalty Pharma. These
statements are based on the current estimates and assumptions of
the management of Theravance Biopharma as of the date of this press
release and are subject to risks, uncertainties, changes in
circumstances, assumptions and other factors that may cause the
actual results of Theravance Biopharma to be materially different
from those reflected in the forward-looking statements. Important
factors that could cause actual results to differ materially from
those indicated by such forward-looking statements include, among
others, risks related to: factors that could increase the Company's
cash requirements or expenses beyond its expectations and any
factors that could adversely affect its profitability, whether the
Trelegy milestone thresholds can be achieved, delays or
difficulties in commencing, enrolling or completing clinical
studies, the potential that results from clinical or non-clinical
studies indicate the Company's product candidates or product are
unsafe, ineffective or not differentiated, risks of decisions from
regulatory authorities that are unfavorable to the Company,
dependence on third parties to conduct clinical studies, delays or
failure to achieve and maintain regulatory approvals for product
candidates, risks of collaborating with or relying on third parties
to discover, develop, manufacture and commercialize products, and
risks associated with establishing and maintaining sales, marketing
and distribution capabilities with appropriate technical expertise
and supporting infrastructure, the ability of the Company to
protect and to enforce its intellectual property rights, volatility
and fluctuations in the trading price and volume of the Company's
shares, and general economic and market conditions. Other risks
affecting Theravance Biopharma are in the Company's Form 10-Q filed
with the SEC on May 12, 2025, and
other periodic reports filed with the United States Securities
Exchange Commission (the "SEC"). In addition to the risks described
above and in Theravance Biopharma's filings with the SEC, other
unknown or unpredictable factors also could affect Theravance
Biopharma's results. No forward-looking statements can be
guaranteed, and actual results may differ materially from such
statements. Given these uncertainties, you should not place undue
reliance on these forward-looking statements. Theravance Biopharma
assumes no obligation to update its forward-looking statements on
account of new information, future events or otherwise, except as
required by law.
Contact:
investor.relations@theravance.com
650-808-4045
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SOURCE Theravance Biopharma, Inc.
