Full Press Release Details
Theravance Biopharma, Inc. Reports Second
Financial Results and Provides Corporate Update
- AUGUST 12, 2025 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today reported financial and operational results for the second quarter of 2025.
execution across our business defined the second quarter, driven by commercial growth, disciplined operations, and continued
progress on ampreloxetine. YUPELRI posted another strong quarter in the U.S., and its recent approval in China triggered a $7.5
million milestone payment. With the completion of the strategic monetization of our TRELEGY royalty interest, which brought in $225
million, these accomplishments have meaningfully strengthened our business," said Rick E Winningham, Chief Executive Officer of
Theravance Biopharma. "We enter the second half of 2025 with momentum and a clear focus on ampreloxetine. We remain on track
for completing the enrollment in our pivotal Phase 3 CYPRESS study in late summer, and continue to prepare for reporting top-line
data approximately six months later."
Second Quarter Operational Highlights:
(revefenacin) inhalation solution, the first and only once-daily, nebulized LAMA (long-acting muscarinic antagonist) bronchodilator approved
in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD):
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 Source: Viatris Customer Demand (Q2'25).
3 Source: IQVIA DDD, HDS, VA and Non-Reporting Hospital
Ampreloxetine, an investigational,
once-daily, selective norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension
(nOH) in patients with multiple system atrophy (MSA):
GSK posted second quarter 2025 global net sales of approximately $1.1
billion (up 4% vs. the second quarter of 2024) and year-to-date net sales of approximately $2.0 billion (up 8% vs. 2024 year-to-date):
Sale of Remaining Royalty Interest in Trelegy Ellipta to GSK:
Second quarter Financial Results:
4 Non-GAAP profit (loss) consists of GAAP net income (loss)
before taxes less (i) share-based compensation expense, (ii) non-cash interest expense, (iii) non-cash impairment expense; and (iv) non-recurring
revenue and income items. See the section titled "Non-GAAP Financial Measures" for more information.
2025 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 / 9:00 pm GMT. To participate in the
live call by telephone, please pre-register here. Those interested in listening to the conference call live via the internet may
do so by clicking here or visiting the Events and Presentation page under the Investors Section on Theravance
Biopharma's website.
A replay of the webcast will be available on Theravance Biopharma's
website for 30 days through September 11, 2025.
Ampreloxetine, an investigational, once-daily, selective norepinephrine
reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple
system atrophy (MSA). The unique benefits of ampreloxetine treatment reported in MSA patients from Study 0170 included an increase in
norepinephrine levels, a favorable impact on blood pressure, clinically meaningful and durable symptom improvement, and no signal for
worsening of supine hypertension. In the US, the Company has been granted an Orphan Drug Designation for ampreloxetine for the treatment
of symptomatic nOH in patients with MSA and, if results from the ongoing Phase 3 CYPRESS study are supportive, plans to file an NDA for
full approval in this indication.
About CYPRESS (Study 0197), a Phase 3 Study
Study 0197 (NCT05696717)
is currently enrolling. This is a registrational Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability
of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment; the primary endpoint of the study is change
in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score. The Study includes four periods: screening, open label (12-week
period, participants will receive a single daily 10 mg dose of ampreloxetine), randomized withdrawal (eight-week period, double-blind,
placebo-controlled, participants will receive a single daily 10 mg dose of placebo or ampreloxetine), and a long-term treatment extension.
Secondary outcome measures include change from baseline in Orthostatic Hypotension Daily Activity Scale (OHDAS) item 1 (activities that
require standing for a short time) and item 3 (activities that require walking for a short time).
About Multiple System Atrophy (MSA) and Symptomatic Neurogenic
Orthostatic Hypotension (nOH)
MSA is a progressive brain disorder that affects movement and balance
and disrupts the function of the autonomic nervous system. The autonomic nervous system controls body functions that are mostly involuntary.
One of the most frequent autonomic symptoms associated with MSA is a sudden drop in blood pressure upon standing (nOH).5 There
are approximately 50,000 MSA patients in the US6 and 70-90% of MSA patients experience nOH symptoms.7 Despite
available therapies, many MSA patients remain symptomatic with nOH.
Neurogenic orthostatic hypotension
(nOH) is a rare disorder defined as a fall in systolic blood pressure of 20 mm
Hg or diastolic blood pressure of 10 mm Hg, within 3 minutes of standing. Severely affected
patients are unable to stand for more than a few seconds because of their decrease in blood pressure, leading to cerebral
hypoperfusion and syncope. A debilitating condition, nOH results in a range of symptoms including dizziness, lightheadedness,
fainting, fatigue, blurry vision, weakness, trouble concentrating, and head and neck pain.
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.
6 UCSD Neurological Institute (25K-75K, with ~10K new cases
per year); NIH National Institute of Neurological Disorders and Stroke (15K-50K).
7 Delveinsight MSA Market Forecast (2023); Symptoms associated
with orthostatic hypotension in pure autonomic failure and multiple systems atrophy, CJ Mathias (1999).
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 Viatris
Specialty LLC. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their
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, Inc. (the "Company") 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 and objectives, future growth of YUPELRI sales, future milestone
or royalty payments, the ability to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies,
the safety, efficacy or differentiation of our investigational therapy, the status of patent infringement litigation initiated by the
Company and its partner against certain generic companies in federal district courts; , and expectations around the use of OHSA scores
as endpoints for clinical trials. 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