Full Press Release Details
Theravance Biopharma, Inc. Reports Third
Financial Results and Announces Initiatives to Unlock Shareholder Value
- NOV. 12, 2024 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today reported financial and operational results for the third quarter of 2024 and announced the formation of a Strategic
Review Committee to assess alternatives to unlock shareholder value.
Reflecting on the quarter's operational
performance, Rick Winningham, Theravance Biopharma CEO commented, "Through our collaboration with Viatris, we achieved a strong
quarter for YUPELRI demand and made progress on recent mix-related pricing headwinds, therein driving quarterly net sales to an all-time
high. We believe we are well positioned to build on recent momentum and achieve continued YUPELRI growth, while continuing to pay careful
attention to our cost structure." He continued, "In addition, we are pleased with the progress we made in CYPRESS this
quarter and reaffirm our development timelines with a goal of making this important therapy available to patients."
Third Quarter Recent 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):
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).
The first payment of $25 million will be triggered if Royalty Pharma (RP) receives $240 million or more in royalty payments from GSK
based on 2024 TRELEGY global net sales, which we expect would occur should TRELEGY global net sales reach approximately $2.9 billion.
A second payment of $25 million (for a total of $50 million) will be triggered if RP receives $275 million or more in royalty payments
from GSK, which we expect would occur should 2024 TRELEGY global net sales exceed approximately $3.2 billion.
Source: Viatris Customer Demand (Q3'24).
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):
Source: IQVIA DDD, HDS, VA and Non-Reporting Hospital through Sep '24.
Hospital LA-NEB Market Share - IQVIA DDD through Sep '24. Community LA-NEB Market Share includes Retail + DME / Med B FFS through
Area under the forced expiratory volume in 1 second vs time curve.
LeMaster, W. B., Witenko, C. J., Lacy, M. K., Olmsted, A. W., Moran, E. J., & Mahler, D. A. (2024). Revefenacin Area Under the Curve
Spirometry in Patients with Moderate to Very Severe COPD. International Journal of Chronic Obstructive Pulmonary Disease, 19,
2299-2308. https://doi.org/10.2147/COPD.S483176
Third Quarter Financial Results
2024 Financial Guidance
Formation of Strategic Review Committee & Enhanced Corporate
The Board of Directors has formed a Strategic
Review Committee (the "Committee") composed entirely of independent directors to assess all strategic alternatives available
to the Company, including those related to YUPELRI, ampreloxetine and TRELEGY, with the objective of unlocking shareholder value. The
Committee is chaired by Susannah Gray and includes Jeremy Grant, Dean Mitchell, Donal O'Connor, and Deepa Pakianathan. Lazard will
be acting as financial advisor to assist in this review process.
There can be no assurance that the Company's
strategic review process will result in any transaction. Theravance Biopharma has not set a timetable for completion of this process,
and it does not intend to disclose further developments unless and until it determines that such disclosure is appropriate or necessary.
Additionally, as part of its ongoing review of its corporate governance
policies, the Company announced today that it has separated the roles of Chair of the Board and Chief Executive Officer. The Company believes
that the separation of these roles will allow management to sharpen its focus on operational goals, including growing YUPELRI and completing
the CYPRESS study. The Board of Directors elected Susannah Gray as Chair of the Board of the Company, while Rick Winningham will
continue as a member of the Board of Directors and Chief Executive Officer.
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.
Settlement Agreement
On September 18, 2024, certain subsidiaries of Theravance Biopharma
and Viatris, entered into a settlement agreement (the "Settlement Agreement") with Qilu Pharmaceutical Co., Ltd. and
Qilu Pharma Inc. (together Qilu) relating to Theravance Biopharma's and Viatris' YUPELRI (revefenacin) inhalation
solution. The Settlement Agreement resolves ongoing patent litigation brought by Theravance Biopharma and Viatris against Qilu pursuant
to the Hatch-Waxman Act based on Qilu's filing of an abbreviated new drug application (ANDA) seeking approval to market a generic
version of YUPELRI (revefenacin) inhalation solution prior to expiration of certain Orange Book listed patents.
Under the Settlement Agreement, Theravance and Viatris granted Qilu
a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market Qilu's 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, the settlement is subject to review by the U.S. Department
of Justice and the Federal Trade Commission. The patent litigation previously disclosed by the Company remains pending against three other
Conference Call and Live Webcast Today at 5:00 pm EST
Theravance Biopharma will hold a conference call and live webcast
accompanied by slides today at 5:00 pm EST / 2:00 pm PST / 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, Events and Presentations.
A replay of the webcast will be available on Theravance Biopharma's
website for 30 days through December 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.
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).9
There are approximately 50,000 MSA patients in the US10 and 70-90% of MSA patients experience
nOH symptoms.11 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.
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).
About Theravance Biopharma
Theravance Biopharma, Inc.'s focus