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Theravance Biopharma, Inc. Reports First Quarter 2024 Financial Results and Provides Business Update Q1 2024 YUPELRI (revefenacin) net sales of $55.2 million, recognized by Viatris, increased 18% from Q1 2023 1 Viatris c

Key Takeaway: Theravance Biopharma, Inc. Reports First Financial Results and Provides Business Update - Q1 2024 YUPELRI (revefenacin) net sales of $55.2 million, recognized by Viatris, increased 18% from Q1 2023 1 - Viatris collaboration revenue of $14.5 million, increased 39% versus Q1 20

Full Press Release Details

Theravance Biopharma, Inc. Reports First
Financial Results and Provides Business Update
- Q1 2024 YUPELRI (revefenacin) net sales of $55.2 million, recognized by Viatris, increased 18% from Q1 2023 1
- Viatris collaboration revenue of $14.5 million, increased 39% versus Q1 2023, reflecting margin improvement
- Continued progress for ampreloxetine CYPRESS enrollment
- Virtual ampreloxetine KOL event scheduled for May 23, 2024
- Q1 2024 ending cash balance of $100 million
- MAY 13, 2024 - Theravance Biopharma, Inc. ("Theravance
Biopharma" or the "Company") (NASDAQ: TBPH) today announced financial and operational results for the first quarter
on recent momentum, the Theravance commercial team again delivered a solid quarter of YUPELRI hospital sales execution in the first quarter,
setting us on a path to contribute significantly to the product's overall growth in 2024", said Rick E Winningham,
Chief Executive Officer. "We remain laser focused on YUPELRI growth and CYPRESS execution and are looking forward to sharing more
about our progress and plans for ampreloxetine at a Key Opinion Leader-led virtual investor event scheduled for May 23rd."
First 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):
- Achieved total net sales of $55.2 million for the quarter, increasing 18% year-over-year (Q1 2024 vs Q1 2023). 1
- Grew doses sold into the hospital channel by 31% year-over-year (Q1 2024 vs Q1 2023). 2
- Increased share within the long-acting nebulized segment of the COPD market. During the quarter, share within the community and hospital settings increased year-over-year to 30.5% and 16.6%, respectively, from 28.0% and 15.0% in Q1 2023. 3
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):
- Virtual ampreloxetine KOL event scheduled for May 23, 2024.
- Enrollment continues globally for the CYPRESS study, with footprint expanded to include active sites in Latin America and Asia Pacific.
- CYPRESS enrollment into the open-label period of the study expected to be completed in the second half of 2024.
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: IQVIA DDD, HDS, VA and Non-Reporting Hospital through Mar'24.
Hospital LA-NEB Market Share - IQVIA DDD through 12/31/2023. Community LA-NEB Market Share includes Retail + DME / Med B FFS through
First Quarter Financial
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%.
2024 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 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 June 12, 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.
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.
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.
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.
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).
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.
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 and objectives, future growth of YUPELRI sales, future royalty payments, the ability to provide value
to shareholders, the Company's regulatory strategies and timing of clinical studies, 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
Last updated: May 13, 2024