Full Press Release Details
Theravance Biopharma, Inc. Reports First
Quarter 2023 Financial Results and Provides Business Update
- May 8, 2023 - Theravance Biopharma, Inc. ("Theravance
Biopharma" or the "Company") (NASDAQ: TBPH) today announced financial and operational results for the first quarter
"Through the beginning of 2023,
we sharpened our commercial and development focus at Theravance, with YUPELRI retail new patient starts growing 61% and
achieving a sixth consecutive quarter of record highs. We also delivered an important clinical milestone, having initiated enrollment
for CYPRESS, our Phase 3 study for ampreloxetine, since our last update", said Rick E Winningham, Chief Executive Officer. "With
the transformation we began nearly two years ago largely completed, we are well positioned to drive an acceleration in YUPELRI performance
made possible by its unique value proposition to COPD patients in both the hospital and community settings. We are determined
to deliver on this opportunity, while returning substantial capital to shareholders and driving our ampreloxetine study to completion."
"For MSA patients suffering
with symptomatic neurogenic orthostatic hypotension (nOH), ampreloxetine has the potential to improve symptoms which impact
their quality of life", said Richard Graham, SVP and Head of R&D. "CYPRESS is a focused Phase 3 study designed
to confirm the clinical improvements ampreloxetine has demonstrated in MSA patients with symptomatic nOH in Study 0170. We plan to complete
enrollment in CYPRESS during the second half of 2024 and provide guidance on timing for top-line results as enrollment progresses."
Quarterly Highlights
In the US, Viatris is leading the commercialization of YUPELRI, and the Company co-promotes the product under a profit and loss sharing
arrangement (65% to Viatris; 35% to the Company).
Symphony Health METYS Prescription Dashboard.
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
First Quarter Financial Results
Total revenue for the first quarter represents a $2.8 million
decrease compared to the same period in 2022, primarily due to a $2.5 million non-recurring milestone payment received in the first quarter
of 2022 related to the Company's licensing arrangement with Pfizer.
Source: GSK-reported Net Sales in USD.
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%.
2023 Financial Guidance
Conference Call and Live Webcast Today at 5:00 pm ET
Theravance 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 IST. 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
6 Non-GAAP profit (loss) consists of GAAP net income (loss)
before taxes less share-based compensation expense and non-cash interest expense. See the section titled "Non-GAAP Financial Measures"
for more information.
A replay of the webcast will be available on
Theravance Biopharma's website for 30 days through June 7, 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 system 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, the impact of recent 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, future YUPELRI sales, the ability
to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies, possible safety,
efficacy or differentiation of our investigational therapy, 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-K filed with the SEC on March 1, 2023, 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 Measures
Theravance Biopharma provides a non-GAAP profitability target and
a non-GAAP metric in this press release. Theravance Biopharma believes that the non-GAAP profitability target and non-GAAP net loss
from operations provide meaningful information to assist investors in assessing prospects for future performance and actual
performance as they provide better metrics for analyzing the 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 and metrics, such as non-GAAP
profitability and non-GAAP net loss from operations, are not standardized, it may not be possible to compare these measures with
other companies' non-GAAP targets or measures having the same or a similar name. Thus, Theravance Biopharma's non-GAAP measures
should be considered in addition to, not as a substitute for, or in isolation from, the Company's actual GAAP results and other
CONSOLIDATED BALANCE SHEETS