Full Press Release Details
Theravance Biopharma, Inc. Reports Fourth
Quarter and Full Year 2020 Financial Results and Provides Business Update
IRELAND - FEBRUARY 23, 2021 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today reported financial results for the fourth quarter and full year ended December 31, 2020.
"2020 was a critical year of growth
for YUPELRI, with our commercial team persevering during a respiratory pandemic and driving increased market share," said
Rick E Winningham, Chief Executive Officer. "This same resilience was seen across our organization, laying the foundation
for this year's clinical development milestones for ampreloxetine and izencitinib. Our focus in 2021 is to deliver on these
milestones in what could be a transformational year."
"Importantly, we are also encouraged
by the initial clinical data from a TD-0903 study in patients hospitalized with acute lung injury due to COVID-19. The data we
are reporting today are from Part 1 of a two-part Phase 2 clinical study. The results show that inhaled administration of nebulized
TD-0903, once daily over seven days, was generally well-tolerated and showed a numerical trend towards improved clinical status,
reduced hospital stay and fewer deaths compared to placebo during a 28-day observation period. We look forward to reporting data
from Part 2 in Q2 2021 and continuing to progress this potential therapy for those hospitalized with COVID-19."
Quarterly Highlights
1 While Viatris, Inc. ("Viatris") records
the total YUPELRI net sales, the Company is entitled to a 35% share of the profits and losses pursuant to a co-promotion agreement
| Placebo (n=6) | 1 mg (n=6) | 3 mg (n=7*) | 10 mg (n=6) | |
| All-Cause Mortality by Day 28 | 2 (33%) | 1 (17%) | 0 (0%) | 0 (0%) |
| Clinical status worsened during 7-day treatment period # | 3 (50%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Alive and Respiratory Failure Free on Day 28 ## | 4 (67%) | 5 (83%) | 6 (86%) | 6 (100%) |
| Mean Time to Hospital Discharge (Days) | 22.5 | 18.8 | 15.3 | 15.2 |
* One patient in the 3 mg group received 2 doses
of TD-0903 before repeated polymerase chain reaction (PCR) testing confirmed the patient did not have COVID-19. The patient was
replaced per the protocol allowances and their data is included for safety but not for efficacy.
# Worsening defined as a score of 8,
7 or 6 on World Health Organization (WHO) COVID-19 Clinical Status Ordinal Scale
Failure Free defined as a score of 1, 2, 3 or 4 on WHO COVID-19 Clinical Status Ordinal Scale
The 3 mg dose is currently being evaluated in Part
2 of the Phase 2 study, which is a randomized, double-blind, parallel-group study evaluating efficacy and safety of a seven-day
course of once-daily nebulized TD 0903 compared to placebo in 198 hospitalized COVID-19 patients. The Company expects to announce
data from Part 2 in Q2 2021.
Upcoming Data Milestones
Fourth Quarter and Full Year Financial Results
As reported by Glaxo Group Limited or one of its affiliates (GSK); reported sales converted to USD; economic interest related
to TRELEGY (the combination of fluticasone furoate, umeclidinium, and vilanterol, (FF/UMEC/VI), jointly developed by GSK and Innoviva,
Inc.) entitles the Company to upward tiering payments equal to approximately 5.5% to 8.5% on worldwide net sales of the product
(net of Theravance Respiratory Company, LLC (TRC) expenses paid and the amount of cash, if any, expected to be used in TRC over
the next four fiscal quarters). 75% of the income from the Company's investment in TRC is pledged to service outstanding
notes, 25% of income from the Company's investment in TRC is retained by the Company.
On June 10, 2020, the Company disclosed in a Form 8-K that it had formally objected to Theravance Respiratory Company, LLC
("TRC") and Innoviva, as the manager of TRC, regarding their proposed plan to use TRELEGY royalties to invest in certain
privately-held companies, funds that would otherwise be available for distribution to the Company under the terms of the TRC LLC
Agreement. The Company intends to continue to seek to protect its interests in this matter consistent with the dispute resolution
procedures of the TRC LLC Agreement. In this regard, the Company initiated an arbitration proceeding against Innoviva and TRC
in October 2020 challenging the authority of Innoviva and TRC to pursue such a business plan rather than distribute such funds
to the Company in a manner consistent with the LLC Agreement and the Company's 85% economic interest in TRC. The arbitration
hearing was held during the week of February 16, 2021, with post-hearing briefing and arguments to take place over the next few
weeks. We currently anticipate a decision in those proceedings near the end of the current quarter or early in the second quarter
2021 Financial Guidance
Conference Call and Live Webcast Today at 5 pm ET
Theravance Biopharma will hold a conference call and live
webcast accompanied by slides today at 5 pm ET / 2 pm PT / 10 pm GMT. To participate, please dial (855) 296-9648 from the U.S.
or (920) 663-6266 for international callers, using the confirmation code 9469708. Those interested in listening to the conference
call live via the internet may do so by visiting Theravance.com, under the Investor Relations section, Events and Presentations.
A replay will be available on Theravance.com
for 30 days through March 25, 2021. An audio replay will also be available through 8:00 pm ET on March 2, 2021 by dialing (855)
859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 9469708.
About Theravance Biopharma
Theravance Biopharma, Inc. is a diversified biopharmaceutical
company primarily focused on the discovery, development and commercialization of organ-selective medicines. Its purpose is to pioneer
a new generation of small molecule drugs designed to better meet patient needs. Its research is focused in the areas of inflammation
In pursuit of its purpose, Theravance Biopharma applies insights
and innovation at each stage of its business and utilize its internal capabilities and those of partners around the world. The
Company applies organ-selective expertise to target disease biologically, to discover and develop medicines that may expand the
therapeutic index with the goal of maximizing efficacy and limiting systemic side effects. These efforts leverage years of experience
in developing lung-selective medicines to treat respiratory disease, including FDA-approved YUPELRI (revefenacin)
inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Its
pipeline of internally discovered programs is targeted to address significant patient needs.
Theravance Biopharma has an economic interest in potential future
payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain
programs, including TRELEGY.
For more information, please visit www.theravance.com.
THERAVANCE and the Cross/Star logo are registered
trademarks of the Theravance Biopharma group of companies. 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.
This press release contains 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 and the Private Securities Litigation Reform Act
of 1995. Examples of such statements include statements relating to: the Company's strategies, plans and objectives,
the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the potential
characteristics, benefits and mechanisms of action of the Company's product and product candidates, the potential that
the Company's research programs will progress product candidates into
the clinic, the Company's expectations for product candidates through development, the Company's expectations regarding
its allocation of resources, potential regulatory approval and commercialization (including their differentiation from other
products or potential products), product sales or profit share revenue and the Company's expectations for its expenses,
excluding share-based compensation and other financial results. These statements are based on the current estimates and
assumptions of the management of Theravance Biopharma as of the date of the 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 related to: current and potential future disagreements with Innoviva, Inc. and TRC LLC, the uncertainty of
arbitration and litigation and the possibility that an arbitration award or litigation result could be adverse to the
Company, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from
clinical or non-clinical studies indicate the Company's compounds or product candidates are unsafe or ineffective,
risks that product candidates do not obtain approval from regulatory authorities, the feasibility of undertaking future
clinical trials for our product candidates based on policies and feedback from regulatory authorities, dependence on third
parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates,
risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and
risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical