Full Press Release Details
Theravance Biopharma, Inc. Reports Record
Fourth Quarter and Full Year 2024 Financial Results
- FEB 26, 2025 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today announced financial and operational results for the fourth quarter and full-year ended December 31, 2024.
"Theravance Biopharma ended 2024 on a
high note, having collaborated closely with Viatris to deliver record fourth quarter YUPELRI net sales and profitability, while achieving
$50 million in TRELEGY related sales milestones," said Rick E Winningham, Theravance Biopharma CEO. "Our hospital-based
commercial organization executed particularly well through the end of the year, positioning us to continue driving YUPELRI growth in 2025
and beyond. These achievements, coupled with steady progress towards enrolling the last patient in the open label portion of our pivotal
CYPRESS Study by mid-2025 and additional potential YUPELRI and TRELEGY milestones in the coming 12-24 months, highlight the multiple components
of value created by our ongoing strategy."
Portfolio Highlights
YUPELRI (revefenacin) inhalation solution, the
first and only once-daily, nebulized LAMA (long- acting muscarinic agent) bronchodilator approved in the US for the maintenance
treatment of patients with chronic obstructive pulmonary disease (COPD):
In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co-promotes the product under a profit and loss
sharing arrangement (65% to Viatris; 35% to Theravance Biopharma).
GSK-reported Net Sales in USD.
A first payment of $25 million was triggered when Royalty Pharma (RP) became eligible to receive $240 million or more in royalty payments
from GSK based on 2024 TRELEGY global net sales and a second payment of $25 million (for a total of $50 million) was triggered when RP
became eligible to receive $275 million or more in royalty payments from GSK. Both royalty thresholds were achieved in the fourth quarter
Source: Viatris Customer Demand (Q4'24).
GSK posted Q4 2024 and FY 2024 global TRELEGY
net sales of $853 million and $3.46 billion, up 16% and 26%, respectively, compared with prior-year periods.2
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):
Fourth Quarter Financial Results
Source: IQVIA DDD, HDS, VA and Non-Reporting Hospital through Dec '24.
Strategic Review Committee
Theravance Biopharma announced on November 12th, 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.
Non-GAAP profit (loss) consists of GAAP net loss before taxes less share-based compensation expense, non-cash interest expense, and non-cash
impairment expense. 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 / 10:00 pm GMT. 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 Events.
A replay of the webcast will be available on Theravance Biopharma's
website for 30 days through March 28, 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 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).7
There are approximately 50,000 MSA patients in the US8 and 70-90% of MSA patients experience
nOH symptoms.9 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.
UCSD Neurological Institute (25K-75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Stroke (15K-50K).
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