Full Press Release Details
Theravance Biopharma, Inc. Reports Fourth
Quarter and Full Year 2023 Financial Results and Provides Business Update
- FEB 26, 2024 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today announced financial and operational results for the fourth quarter of 2023 and full-year ended December 31,
"The Theravance team delivered a strong
performance in 2023, having achieved our financial objectives in the fourth quarter and exceeded our aggressive annual goal for YUPELRI
hospital growth," said Rick E Winningham, Chief Executive Officer. "We look forward to continuing YUPELRI net sales growth
in 2024 and completing enrollment in the CYPRESS study in the second half of this year. Further, we are excited to host a virtual investor
event in the second quarter, where both MSA thought leaders and members of Theravance's senior management team will review the science
underpinning our expectation that ampreloxetine can provide clinical benefits in MSA patients with nOH."
2023 Year-End-Highlights
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).
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.
Fourth Quarter Accomplishments
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):
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):
Source: GSK-reported Net Sales in USD.
The next milestone payment of $25.0 million will be triggered if Royalty Pharma receives $240.0 million or more in royalty payments from
GSK with respect to 2024 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales reach approximately
$2.863 billion. Another milestone payment of $25.0 million will be received if Royalty Pharma receives $275.0 million or more in royalty
payments from GSK with respect to 2024 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales
reach approximately $3.213 billion. Royalties payable from GSK to Royalty Pharma are upward tiering from 6.5% to 10%.
Viatris reported customer demand Q4'23: inclusive of direct customer shipments to various channels, including DMEs, retail pharmacies
Hospital LA-NEB Market Share - IQVIA DDD through 12/31/2023. Community LA-NEB Market Share includes Retail + DME / Med B FFS through
Fourth Quarter Financial Results
2024 Financial Guidance
Settlement Agreements
Certain subsidiaries of Theravance Biopharma and Mylan Ireland Limited
and Mylan Specialty L.P. (together, "Viatris") entered into a settlement agreement (1) on October 27, 2023 with
Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. (together, "Teva"); (2) on December 26,
2023 with Accord Healthcare, Inc. ("Accord"); and (3) on January 12, 2024 with Orbicular Pharmaceutical Technologies
Private Limited ("Orbicular"), in each case relating to Theravance Biopharma and Viatris's YUPELRI (revefenacin)
inhalation solution. These settlement agreements resolve ongoing patent litigation brought by Theravance Biopharma and Viatris against
Teva, Accord and Orbicular pursuant to the Hatch-Waxman Act based on Teva, Accord and Orbicular's respective filings of an abbreviated
new drug application seeking approval to market a generic version of YUPELRI (revefenacin) inhalation solution prior
to expiration of the Orange Book Listed Patents.
Theravance Biopharma and Viatris granted each of Teva, Accord and Orbicular
under their applicable settlement agreements, a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture
and market the respective parties generic version of YUPELRI (revefenacin) inhalation solution in the United States
on or after the licensed launch date of April 23, 2039, subject to certain exceptions as is customary in these types of agreements.
As required by law, these settlements are subject to review by the U.S. Department of Justice and the Federal Trade Commission. The patent
litigation previously disclosed by the Company against the other four ANDA filers, along with certain affiliates, remains pending.
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 27, 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.
The company has been granted an orphan drug designation in the US and, if results support it, plans to file an NDA for full approval based
on the Phase 3 CYPRESS study.
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).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
UCSD Neurological Institute (25K-75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and
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
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