Full Press Release Details
Theravance Biopharma, Inc. Reports Third Quarter
2023 Financial Results and Provides Business Update
IRELAND - NOV 7, 2023 - Theravance Biopharma, Inc. ("Theravance
Biopharma" or the "Company") (NASDAQ: TBPH) today announced financial and operational results for the third quarter
"We are pleased with the company's bottom line performance
in the third quarter, driven by a combination of continued YUPELRI growth and expense management, which positioned us to report a non-GAAP
loss of less than $1 million," said Rick E Winningham, Chief Executive Officer. "In addition, as we work with the MSA
community to activate sites globally and enroll our Phase 3 CYPRESS study, our conviction in ampreloxetine's potential to address
unmet needs of MSA patients and caregivers burdened by symptomatic nOH remains strong."
"With her extensive contributions at Theravance and prior
strategic development and regulatory leadership experience at Alkermes, Elan, and Allergan, Aine is well positioned to lead the Development
organization through completion of the CYPRESS study, NDA submission and beyond," said Rick E Winningham. "I am pleased
that Rick will stay through February to ensure we meet our PIFR-2 commitments and maintain our momentum in CYPRESS but will miss his steadfast
leadership and camaraderie - he has been an important partner in Theravance's success."
Third Quarter 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):
1 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).
2 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.
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):
3 Viatris reported customer demand Q3'23: inclusive of
direct customer shipments to various channels, including DMEs, retail pharmacies and hospitals.
4 Symphony Health METYS Prescription Dashboard. Retail
data serves as a proxy for the total community (Retail + DME).
5 Hospital LA-NEB Market Share - IQVIA DDD through 9/30/2023.
Community LA-NEB Market Share includes Retail + DME / Med B FFS through July '23.
TRELEGY ELLIPTA, the first once-daily single inhaler triple
therapy for COPD and asthma:
Third Quarter Financial Results
6 Source: GSK-reported
7 The first milestone
payment of $50.0 million will be triggered if Royalty Pharma receives $240.0 million or more in royalty payments from GSK with respect
to 2023 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales reach approximately $2.863 billion.
Royalties payable from GSK to Royalty Pharma are upward tiering from 6.5% to 10%.
2023 Financial Guidance
Effective November 7, 2023, ine Miller, Ph.D., will assume
the role of SVP, Development at Theravance Biopharma, replacing Richard A Graham, Ph.D. Dr. Miller has been with the company for nearly
four years in increasing positions of leadership and currently serves as the company's Vice President, Regulatory, Quality and Clinical
Safety & Pharmacovigilance. Dr. Miller led Theravance's Type C meeting with the FDA, reaching alignment on the design of the
ampreloxetine Cypress study, our single Phase 3 study to support US approval. Rick Graham, Ph.D., will be leaving the company after eight
years of significant contributions towards establishing and optimizing Theravance Biopharma's development capabilities. Rick will
continue in a strategic advisor role through the read out and communication of the PIFR-2 study results and will work towards a seamless
transition through the end of February 2024.
2024 Annual General Meeting of Shareholders; Board of Directors
The Company will hold its 2024 Annual General Meeting of
Shareholders on May 8, 2024, in Dublin, Ireland (2024 AGSM). Dr. Burton Malkiel has informed the Company that he does not intend to
stand for re-election at the 2024 AGSM. Reflecting better alignment with the smaller size and focus of the Company, the Board has
approved reducing the size of the Board from 9 persons to 8 persons effective automatically upon the completion of Dr.
Malkiel's term at the 2024 AGSM.
Settlement Agreement
On October 27, 2023, certain subsidiaries of Theravance Biopharma and
Mylan Ireland Limited and Mylan Specialty L.P. (together, "Viatris") entered into a Settlement Agreement with Teva Pharmaceuticals,
Inc. and Teva Pharmaceuticals USA, Inc. (together, "Teva"), relating to Theravance and Viatris's YUPELRI
(revefenacin) inhalation solution. The Settlement Agreement resolves ongoing patent litigation brought by Theravance and Viatris against
Teva pursuant to the Hatch-Waxman Act based on Teva's filing 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.
Under the Settlement Agreement, Theravance and Viatris granted Teva
a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market Teva'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 against the other six ANDA filers, along with
certain affiliates, remains pending.
Conference Call and Live Webcast Today at 5:00 pm ET
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 December 7, 2023.
About the PIFR-2 Study
This study is a randomized, double-blind,
parallel-group study, comparing improvements in lung function in adults with severe to very severe COPD and low peak inspiratory
flow rate following once-daily treatment over 12 weeks with either YUPELRI (revefenacin) inhalation solution delivered via standard
jet nebulizer or SPIRIVA (tiotropium) delivered via a dry powder inhaler (Spiriva HandiHaler ).
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 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