DUBLIN and SOUTH SAN FRANCISCO, Calif., Sept. 15, 2021 /PRNewswire/ -- Theravance
Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ:
TBPH) today announced strategic actions to focus on leveraging its
expertise in developing and commercializing respiratory
therapeutics in order to maximize shareholder value. These changes
follow a comprehensive scenario planning exercise led by the Board
and Management with the assistance of outside advisors. In order to
implement this plan, Theravance Biopharma will immediately initiate
a significant cost reduction program:
- Headcount will be reduced by approximately 75%, an estimated
270 positions1, with approximately 75% of the reduction
expected to be completed in November
2021 and the remainder to be completed in February 2022
- Total annualized operating expense2 savings of
approximately $165 million in 2022
compared with the Company's updated 2021 Financial Guidance
below
Updated 2021 and Preliminary 2022 Financial
Guidance2:
Expenses
$ million
|
2021 Initial
Guidance
|
2021 Updated
Guidance
|
2022 Preliminary
Guidance
|
R&D
|
$195 – 225
|
$180 – 190
|
$55 – 65
|
SG&A
|
$80 – 90
|
$70 – 80
|
$30 – 40
|
By implementing these strategic actions, Theravance Biopharma
expects to become sustainably cash flow positive beginning in the
second half of 2022.
The go-forward organization will build on the Company's proven
track record of innovation leading to several approved medicines
for COPD and asthma, including YUPELRI®, launched in
2019, which was discovered and developed by the Company and is now
commercialized in partnership with Viatris Inc., and TRELEGY, a
respiratory medicine developed by Glaxo Group Limited in
collaboration with the Company's predecessor, Theravance, Inc.
TRELEGY is currently expected to generate global peak sales of
approximately $3.0 billion
annually3. YUPELRI remains early in its product
lifecycle, has demonstrated quarter-over-quarter market share
growth, and has the potential to generate US peak sales
exceeding $400 million4.
Theravance Biopharma believes the strong and growing cash flows of
YUPELRI and TRELEGY will generate significant value creation
opportunities for the Company's shareholders.
In addition, the Company intends to significantly narrow its
R&D focus on its core respiratory assets, including a clinical
study in partnership with Viatris Inc., intended to generate data
supporting label expansion for YUPELRI, which would
significantly increase YUPELRI's addressable market, and investment
in Theravance Biopharma's inhaled Janus kinase inhibitor portfolio,
with focus on the most advanced clinical candidate, nezulcitinib,
initially targeting acute lung injury. In order to implement this
plan, the Company will halt the development of all non-respiratory
disease related programs except that it will close-out the
izencitinib Phase 2 Crohn's disease Study 0157 (NCT03758443) and
the ampreloxetine Phase 3 REDWOOD Study 0170 (NCT03829657).
Furthermore, management will work to optimize the Company's
capital structure as financial flexibility increases in order to
maximize total shareholder returns. Management will also prioritize
initiatives that seek to realize the value of the Company's
non-core assets and partnerships.
"Given the recent results from our late-stage development
programs, we have made the difficult but necessary decision to
focus our resources on our most promising respiratory programs and
reduce the size of the organization," said Rick E Winningham,
Chairman and Chief Executive Officer. "I want to thank all of
the patients who participated in our clinical trials and their
families, the investigators, as well as the Theravance Biopharma
employees who have worked tirelessly on these programs. I am
grateful for the team's significant contributions over the years. I
am confident these actions will help us to continue making
transformational medicines aimed at improving the lives of patients
suffering from serious respiratory illnesses while creating value
for our shareholders."
The Company has also decided to reduce the size of its Board,
and is announcing the resignations from the Board of two long-term
directors: George M. Whitesides,
Ph.D., and Robert V. Gunderson, Jr.,
effective September 14, 2021 and
September 11, 2021,
respectively. Dr. Whitesides has served on the Board of the
Company and its predecessor, Theravance, Inc., since its inception
in 1996. Mr. Gunderson has served on the Board of the Company
and its predecessor, Theravance, Inc., since September
1999. "George and Bob each have dedicated themselves to the
Company and its predecessor for over two decades, providing their
valuable expertise to us on a variety of matters. On behalf of my
fellow Board members I thank them both for their many contributions
to the Company over their years of service," said
Winningham.
Conference Call and Live Webcast Today at 8:00 AM ET (5:00 AM
PT)
Theravance Biopharma will hold a conference call and live
webcast today at 8:00 AM ET / 5:00 AM PT. To
participate, please dial (855) 296-9648 from the U.S. or (920)
663-6266 for international callers, using the confirmation code
6475192. Those interested in listening to the conference call live
via the internet may do so by visiting www.theravance.com,
under the Investors section, Events and Presentations.
A replay will be available on www.theravance.com for
30 days through October 15, 2021. An
audio replay will also be available through 11:00 AM ET on
September 22, 2021, by dialing (855)
859-2056 from the U.S., or (404) 537-3406 for international
callers, and then entering confirmation code 6475192.
About Theravance Biopharma
Theravance Biopharma, Inc. is a biopharmaceutical company
primarily focused on the discovery, development and
commercialization of respiratory medicines. Its core purpose is to
create medicines that help improve the lives of patients suffering
from respiratory illness.
In pursuit of its purpose, Theravance Biopharma leverages
decades of respiratory expertise to discover and develop
transformational medicines that make a difference. These efforts
have led to the development of FDA-approved
YUPELRI® (revefenacin) inhalation solution
indicated for the maintenance treatment of patients with chronic
obstructive pulmonary disease (COPD). Its respiratory pipeline of
internally discovered programs is targeted to address significant
patient respiratory 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 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
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 goals, designs, strategies,
plans and objectives, the impact of the Company's restructuring
plan, ability to provide value to shareholders, 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 and the
market for products being commercialized, the Company's
expectations regarding its allocation of resources, potential
regulatory actions and commercialization (including differentiation
from other products or potential products and addressable market),
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: disagreements with Innoviva, Inc. and TRC
LLC, the uncertainty of arbitration and litigation and the
possibility that the results of these proceedings could be adverse
to the Company, additional future analysis of the data resulting
from our clinical trial(s), 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, products or product candidates are unsafe,
ineffective or not differentiated, risks of decisions from
regulatory authorities that are unfavorable to the Company, the
feasibility of undertaking future clinical trials 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 expertise and
supporting infrastructure, ability to retain key personnel, the
impact of the Company's restructuring actions on its employees,
partners and others. In addition, while we expect the effects of
COVID-19 to continue to adversely impact our business operations
and financial results, the extent of the impact on our ability to
generate revenue from YUPELRI® (revefenacin), our
clinical development programs (including but not limited to our
later stage clinical programs for izencitinib and ampreloxetine),
and the value of and market for our ordinary shares, will depend on
future developments that are highly uncertain and cannot be
predicted with confidence at this time. These potential future
developments include, but are not limited to, the ultimate duration
of the COVID-19 pandemic, travel restrictions, quarantines, social
distancing and business closure requirements in the United States and in other countries,
other measures taken by us and those we work with to help protect
individuals from contracting COVID-19, and the effectiveness of
actions taken globally to contain and treat the disease, including
vaccine availability, distribution, acceptance and effectiveness.
Other risks affecting Theravance Biopharma are in the Company's
Form 10-Q filed with the SEC on August 5,
2021 and other periodic reports filed with the SEC. In
addition to the risks described above and in Theravance Biopharma's
filings with the SEC, other unknown or unpredictable factors also
could affect Theravance Biopharma's results. No forward-looking
statements can be guaranteed, and actual results may differ
materially from such statements. Given these uncertainties, you
should not place undue reliance on these forward-looking
statements. Theravance Biopharma assumes no obligation to update
its forward-looking statements on account of new information,
future events or otherwise, except as required by law.
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1 Regular
and contingent workers.
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2 Excludes share-based compensation
and any one-time costs related to strategic actions.
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3 Source: Bloomberg Consensus
September 2021.
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4 Source: TBPH Broker Consensus
September 2021.
|
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Contact: Gail B. Cohen
Corporate Communications
917-214-6603
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SOURCE Theravance Biopharma, Inc.