Full Press Release Details
Theravance Biopharma, Inc. Reports Second
Quarter 2023 Financial Results and Provides Business Update
- aug 7, 2023 - Theravance Biopharma, Inc. ("Theravance
Biopharma" or the "Company") (NASDAQ: TBPH) today announced financial and operational results for the second quarter
"We are very encouraged
by our team's performance in Q2, with YUPELRI achieving good growth in both the hospital and community settings over the prior year,"
said Rick E Winningham, Chief Executive Officer. "We are excited to capitalize on the commercial opportunity for YUPELRI, potentially
enhanced near-term by PIFR-2, and realize the significant opportunity for ampreloxetine to dramatically improve the lives of MSA patients
with symptomatic nOH."
Quarterly Highlights
Theravance expects to complete enrollment in the YUPELRI
PIFR-2 study shortly, with top-line data to be available late in the fourth quarter of 2023. The Company expects to disclose top line
results in January 2024. PIFR-2 evaluates revefenacin delivered via jet nebulizer compared to tiotropium delivered via dry powder
inhaler in severe to very severe COPD patients with suboptimal peak inspiratory flow rate.
1 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).
2 Symphony Health METYS Prescription Dashboard. Retail
data serves as a proxy for the total community (Retail + DME).
3 Hospital LA-NEB Market Share - IQVIA DDD through 6/30/2023.
Community LA-NEB Market Share includes Retail + DME / Med B FFS through May'23.
$80.5 million of share buybacks
completed in Q2 2023 and $263.8 million from program inception through June 30, 2023. As of June 30, 2023, the Company had $61.2
million remaining in the program, which is expected to be completed by the end of 2023. The Company remains on track to achieve non-GAAP
profitability in H2 '23, subject to YUPELRI's increased net sales growth4.
Second Quarter Financial Results
Total revenue for the second quarter represents a $2.7 million
increase compared to the same period in 2022, primarily due to an increase in YUPELRI net sales.
4 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.
5 Source: GSK-reported Net Sales in USD.
6 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
A replay of the webcast will be available on
Theravance Biopharma's website for 30 days through September 6, 2023.
About the PIFR-2 Study
This study is a randomized, double-blind,
parallel-group study, comparing improvements in lung function in adults with severe to very severe COPD and suboptimal inspiratory
flow rate following once-daily treatment over 12 weeks with either YUPELRI (revefenacin) inhalation solution delivered via standard
jet nebulizer or SPIRIVA (tiotropium) delivered via a dry powder inhaler (Spiriva HandiHaler ).
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 and the conference call 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 the conference call 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 May 10, 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
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