Full Press Release Details
Theravance Biopharma, Inc. Highlights 2022
Accomplishments and 2023 Key Targets
- JANUARY 9, 2023 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today announced its 2022 Accomplishments and 2023 Key Targets.
was a transformative year for Theravance Biopharma and demonstrates the power of a team that leans into the Company's values and
core purpose: delivering medicines that make a difference. After restructuring in late 2021, we narrowed our focus, executed on our strategy,
and delivered on our key goals. YUPELRI produced all-time high net sales, profitability, and market share in Q2 and Q3,
and we expect continued growth in Q4 and beyond. Positive PIFR-2 results in 2023 will enhance the growth trajectory of YUPELRI. Based
on successful discussions with the FDA, we will conduct one additional study in MSA patients which is planned to start in Q1 2023. With
the new study and a substantial body of preclinical and clinical data in-hand, we have confidence in our ability to file an NDA for ampreloxetine
as a treatment for MSA patients with symptomatic nOH. The sale of our TRELEGY ELLIPTA royalty interests to Royalty Pharma for over $1.5
billion in potential value enabled us to eliminate all of our debt and has facilitated the initiation of a return of capital program to
about the future of the Company and grateful for the team that has refocused the portfolio and reinvigorated our business model. With
an attractive financial profile and several planned near-term milestones, we are well positioned to create shareholder value in 2023 and
beyond," said Rick E Winningham, Chief Executive Officer.
2022 Accomplishments:
is expected to consist of GAAP income before taxes less share-based compensation expense and non-cash interest expense. See the section
titled "Non-GAAP Financial Measure" for more information.
2 Year-to-date through
3 Data from MSA patients
at week 6 of the randomized withdrawal period of Study 0170.
al. Abstract 34 / Virtual Poster 106; Kaufmann H, et al. Abstract 33 / Virtual Poster 117; Freeman R, et al. Abstract 30
5 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
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). Its pipeline
of internally discovered programs is targeted to address significant unmet patient needs.
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: contingent
payments due to the Company from the sale of the Company's TRELEGY ELLIPTA royalty interests to Royalty Pharma, 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 (including the data therefrom), the potential characteristics, benefits and mechanisms of action of the Company's
product and product candidates, including potential points of differentiation, the market for products being commercialized and product
candidates, product sales or profit share revenue and the Company's expectations for its future financial performance and expectations
as to future cash flows, the effectiveness of the Company's intellectual property portfolio, and the Company's repurchase
of its ordinary shares by way of an open market share repurchase program. 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
presentation. Theravance Biopharma believes that the non-GAAP profitability target provides meaningful information to assist investors
in assessing prospects for future performance as it provides a better metric for analyzing the future potential performance of its business
by excluding items that may not be indicative of core operating results and the Company's cash position. Because non-GAAP financial targets,
such as non-GAAP profitability, are not standardized, it may not be possible to compare this target with other companies' non-GAAP targets
or measures having the same or a similar name. Thus, Theravance Biopharma's non-GAAP target should be considered in addition to, not as
a substitute for, in in isolation from, the company's actual GAAP results and other targets.