Full Press Release Details
Theravance Biopharma, Inc. Reports Second
Financial Results and Provides Business Update
- AUG. 5, 2024 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today announced financial and operational results for the second quarter of 2024.
"YUPELRI net sales decreased 1% from
the prior quarter, owing to near-term headwinds from an evolved channel mix and a lower realized net price," said Rick Winningham,
Theravance Biopharma CEO. "We are disappointed with this quarter's net sales result, but remain confident in our ability to
continue to grow YUPELRI in the future, given strong and consistent demand generation." He continued, "In addition, while
we have activated over 80% of study sites in CYPRESS and achieved solid enrollment in the quarter, we now anticipate enrolling the last
patient into the open-label portion of the study in mid-2025. We continue to prioritize delivering a high-quality study in pursuit of
making ampreloxetine available to those MSA patients suffering without viable treatment options for their symptomatic nOH. Finally, we
are pleased with another exceptional quarter for TRELEGY, which increases our confidence in achieving milestones in 2024, which would
contribute to our existing balance sheet strength."
Second Quarter Highlights
(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 the Company co-promotes the product under a profit and loss sharing
arrangement (65% to Viatris; 35% to the Company).
Source: Viatris Customer Demand (Q2'24).
Source: IQVIA DDD, HDS, VA and Non-Reporting Hospital through Jun '24.
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):
Second Quarter Financial Results
Hospital LA-NEB Market Share - IQVIA DDD through Jun '24. Community LA-NEB Market Share includes Retail + DME / Med B FFS through
Updated 2024 Financial Guidance
Non-GAAP profit (loss) consists of GAAP net income (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.
Corporate Initiatives to Maximize Shareholder Value
Pursuant to a recently-completed review of its substantial Irish tax
assets, the Company is engaging tax and financial advisors to explore opportunities through which to unlock value, given the gap between
our share price and the value of our diverse and unique portfolio, including YUPELRI, ampreloxetine, TRELEGY and the Company's tax
assets. We will provide further updates as appropriate.
Intellectual Property Updates
Patent Infringement Suits
Patent litigation is pending against four companies, along with certain
affiliates; we previously disclosed litigation involving three of these companies. In June 2024, the Company filed a patent infringement
suit in the U.S. District Court for the Eastern District of Pennsylvania against a subsequent filer of an abbreviated new drug application
(ANDA) for a generic version of YUPELRI. As a result of this lawsuit, a 30-month stay of approval through November 2026 would be
expected to be automatically granted by the FDA on the subsequent filer's ANDA pending any adverse court decision. As of July 31,
2024, the Company has settled litigation with four companies pursuant to individual agreements in which we granted these companies a royalty-free,
non-exclusive, non-sublicensable, non-transferable license to manufacture and market their respective generic versions of YUPELRI inhalation
solution in the US on or after the licensed launch date of April 23, 2039, subject to certain exceptions as is customary in these
type of agreements. As required by law, the settlements are subject to review by the U.S. Department of Justice and the Federal Trade
An additional method of use patent for YUPELRI was granted on July 30,
2024, which expires in August 2039, and is listed in the FDA Orange Book.
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, Events and Presentations.
A replay of the webcast will be available on Theravance Biopharma's
website for 30 days through September 4, 2024.
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 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
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 nOH.
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).
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.