Full Press Release Details
Theravance Biopharma, Inc. Announces Strategic
Actions and Reports Fourth Quarter / Full Year 2022 Financial Results and Business Update
IRELAND - FEBRUARY 27, 2023 - Theravance Biopharma, Inc.
("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced financial results for the fourth quarter
and full year ended December 31, 2022. The Company also announced three additional strategic actions to sharpen the Company's focus
and deliver on its commitment to create shareholder value:
"With the successful evolution of Theravance over the past
18 months, we continue to strengthen our position via these strategic actions that build on our focus, execution and measured spending,"
said Rick E Winningham, Chief Executive Officer. "We remain laser focused on enhancing near- and long-term shareholder value and delivering medicines that make a difference to patients. We are well positioned to drive YUPELRI's growth by building on the 25% annual growth the
team achieved last year and generating data from the PIFR-2 study in the second half of 2023. We are advancing our pipeline with the initiation
of the Phase 3 study for ampreloxetine and are pursuing orphan drug designation to help bring this potential first-in-class therapy to
multiple systems atrophy patients in need of symptomatic nOH relief. We are upsizing our capital return program to $325 million and expect
to complete the program by the end of the year. And, importantly, we remain committed to achieving non-GAAP profitability by the second
half of this year and confident in our plan to enhance shareholder value."
"On behalf of the Board and management team, we would like
to thank Bill for his many contributions and guidance during his tenure with the Company," added Mr. Winningham. "As
a director, Bill has been an instrumental contributor of industry and corporate governance expertise and a strong steward of shareholder
interests during his tenure. We wish him the very best in his future endeavors."
Mr. Young commented, "I am grateful
for the opportunity to have served Theravance shareholders as a director. In that time, the Company has experienced significant
transformation and I'm confident that the appointment of Susannah will further strengthen the Board's ability to guide
and oversee the Company as it capitalizes on its next era of growth."
Winningham continued, "Susannah is a highly respected industry
executive with expertise that will deepen the diverse perspective of the Board. We look forward to benefiting from her insights as we
look to deliver transformative medicines and create shareholder value."
Ms. Gray commented, "I am honored to have this opportunity
to serve on the Board and leverage my experience to support Theravance's ongoing transformation and development of Medicines that
Make a Difference. I look forward to the opportunity to work with the Company as it executes its strategic plan to maximize value for
2023 Financial Guidance
2022 Year-end Highlights
Fourth Quarter and Full Year Financial Results
While Viatris, Inc. ("Viatris") records the total YUPELRI net sales, the Company is entitled to a 35% share of the profits
and losses pursuant to a co-promotion agreement with Viatris.
2 November 2022, Biaggioni I, et al. Abstract 34 / Virtual
Poster 106; Kaufmann H, et al. Abstract 33 / Virtual Poster 117; Freeman R, et al. Abstract 30 / Virtual Poster 4
The first milestone payment of $50.0 million, will be triggered if Royalty Pharma receives $240.0 million or more in royalty payments
from GSK with respect to 2023 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales reach approximately
$2.863 billion. Royalties payable from GSK to Royalty Pharma are upward tiering from 6.5% to 10%.
Biography - Susannah Gray, New Independent Director
Susannah Gray served as the Executive Vice President and Chief Financial
Officer of Royalty Pharma, the largest aggregator of pharmaceutical royalty interests worldwide, from January 2005 to December 2018. She
was promoted to Executive Vice President of Finance and Strategy in December 2018 and retired from Royalty Pharma in September 2019. Prior
to Royalty Pharma, Ms. Gray served as a managing director and senior analyst covering the healthcare sector in CIBC World Markets'
high yield group from 2002 to 2004, and also previously served in similar roles at Merrill Lynch and Chase Securities (predecessor of
J.P. Morgan Securities). She currently serves on the Boards of Directors of Maravai LifeSciences, 4D Molecular Therapeutic
and Morphic Therapeutic. Previously, Ms. Gray served on the Board of Directors of Apria until its sale to
Owens & Minor. Ms. Gray received a BA, with honors, from Wesleyan University and an MBA from Columbia University.
Conference Call and Live Webcast Today at 5:00 pm ET
Biopharma will hold a conference call and live webcast accompanied by slides today at 5:00 pm ET / 2:00 pm PT / 10:00 pm GMT.
To participate in the live call by telephone, please register here. Those interested in listening to the conference call live
via the internet may do so by visiting Theravance Biopharma's website at www.theravance.com, under the Investors section,
Presentations and Events.
A replay of the webcast will be available on Theravance
Biopharma's website for 30 days through March 29, 2023.
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 norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension, has
the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in multiple symptom atrophy 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 on this press
release are the property of their respective owners.
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
repurchase of its ordinary shares by way of an open market share repurchase program, headcount reductions in connection with focusing
investments in research, the Company's governance policies and plans, the Company's expectations regarding its allocation
of resources and maintenance of expenditures, the Company's goals, designs, strategies, plans and objectives, the ability to provide
value to shareholders, the Company's regulatory strategies and timing of clinical studies, and contingent payments due to the Company
from the sale of the Company's TRELEGY ELLIPTA 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: whether the 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, ability to retain key personnel, the impact of the Company's
recent restructuring actions on its employees, partners and others, 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 November 9, 2022, and other
periodic reports filed with 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.
Non-GAAP Financial Measure
Theravance Biopharma provides a non-GAAP profitability target in this