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Theravance Biopharma, Inc. Reports First Quarter 2025 Financial Results and Provides Corporate Update YUPELRI (revefenacin) net sales of $58.3 million, recognized by Viatris, increased 6% versus Q1 2024 1 TRELEGY net sal

Key Takeaway: Theravance Biopharma, Inc. reported a solid financial performance for Q1 2025, with YUPELRI net sales growing by 6% year-over-year to reach $58.3 million. The company highlighted its strong commercial partnership with Viatris, which is managing YUPELRI's market presence. The ongoing Phase 3 CYPRESS study for ampreloxetine, aimed at treating symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy, is nearing enrollment completion. The company remains focused on strategies to enhance shareholder value through its Strategic Review Committee.

Market Sentiment Analysis

POSITIVE FACTORS

  • YUPELRI net sales for Q1 2025 reached $58.3 million, reflecting 6% growth year-over-year.
  • Commitment to completing CYPRESS enrollment for ampreloxetine to support its NDA filing.
  • Strong commercial partnership with Viatris, contributing positively to YUPELRI sales.
  • Ampreloxetine shows promising clinical benefits for MSA patients with potential for FDA approval.

Full Press Release Details

Theravance Biopharma, Inc. Reports First
Financial Results and Provides Corporate Update
- MAY 8, 2025 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today reported financial and operational results for the first quarter of 2025.
"As we begin the year, we remain focused
on delivering against our operational priorities for YUPELRI and ampreloxetine," said Rick E Winningham, CEO of Theravance Biopharma.
"Our commercial partnership with Viatris delivered solid YUPELRI sales growth, aided by a strong performance in the hospital
setting. TRELEGY delivered another excellent quarter and our clinical team advanced CYPRESS enrollment, which is now nearing completion.
Our interactions with the MSA community continue to highlight the urgent need for new treatments for symptomatic nOH and ampreloxetine's
potentially significant value to patients, caregivers and providers, underpinning our motivation to complete CYPRESS enrollment and share
First Quarter Operational Highlights
YUPELRI (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 GSK-reported Net Sales in USD.
3 Source: Viatris Customer Demand (Q1'25).
4 Source: IQVIA DDD, HDS, VA and Non-Reporting Hospital through Mar '25.
Ampreloxetine, an investigational, once-daily norepinephrine
reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple
system atrophy (MSA):
GSK posted first quarter 2025 global net sales of $854 million (up
14% from $749 million reported in the first quarter of 2024):
First Quarter Financial Results
Strategic Review Committee
Theravance Biopharma announced on November 12,
2024, that the Board of Directors had formed a Strategic Review Committee (the "Committee") composed entirely of independent
directors to assess all strategic alternatives available to the Company. The Committee is continuing to evaluate a range of alternatives
with the objective of unlocking shareholder value. Until this review is complete, we are not in a position to provide additional details
on the review process.
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 / 10:00 pm GMT. To participate in the live call by telephone, please dial
(800) 715-9871 from the US or (646) 307-1963 for international callers, using the Conference ID 3369474. 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 June 7, 2025.
Ampreloxetine, an investigational, once-daily 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
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
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).6
There are approximately 50,000 MSA patients in the US7 and 70-90% of MSA patients experience
nOH symptoms.8 Despite available therapies, many MSA patients remain symptomatic with
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.
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 in this press
release are the property of their respective owners.
6 https://medlineplus.gov/genetics/condition/multiple-system-atrophy/
7 UCSD Neurological Institute (25K-75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Stroke (15K-50K).
8 Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure and multiple systems atrophy, CJ Mathias (1999).
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 expectations regarding its future profitability, expenses and uses of cash, the Company's
goals, designs, strategies, plans, potential, and objectives, future growth of YUPELRI sales, future milestone and royalty payments, the
ability to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies, potential or possible
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; contingent payments due to the Company from the sale of
the Company's TRELEGY ELLIPTA royalty interests to Royalty Pharma, 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 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: factors that could increase the Company's cash requirements or expenses beyond its expectations
and any factors that could adversely affect its profitability, 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

Frequently Asked Questions

What is YUPELRI used for?

YUPELRI (revefenacin) is a once-daily nebulized bronchodilator approved for COPD maintenance.

What is ampreloxetine developed for?

Ampreloxetine is an investigational drug aimed at treating symptomatic neurogenic orthostatic hypotension.

Who commercializes YUPELRI?

Viatris leads the commercialization of YUPELRI, with Theravance Biopharma co-promoting it.

What is the goal of the CYPRESS study?

The CYPRESS study aims to evaluate the efficacy of ampreloxetine in patients with MSA and nOH.

How many patients have MSA in the US?

Approximately 50,000 patients in the US are diagnosed with Multiple System Atrophy.

Last updated: May 8, 2025