Full Press Release Details
Theravance Biopharma,
Inc. Reports Third Quarter 2022
Financial Results, Provides Business Update and Extends Tender Offer
IRELAND - NOVEMBER 7, 2022 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today reported financial results for the third quarter of 2022.
quarter is a milestone in the Company's transformation and demonstrates the power of a team of people who are focused
and stay true to the Company's purpose, delivering medicines that make a difference. I am proud and grateful for the team that has
refocused the portfolio and monetized our interest in TRELEGY to reposition and reinvigorate the Company's business model. Theravance
Biopharma today is debt free, and I believe we are well-positioned for value creation," said Rick E Winningham, Chief Executive
Quarterly Highlights
The Company held a Type C meeting with the FDA in June
2022 and agreed on a path to NDA filing with one new Phase 3 clinical study in MSA patients with symptomatic nOH which is planned to
start in the first quarter of 2023. The registrational
Phase 3 Study in MSA patients with nOH (Study 0197, CYPRESS) is expected to be a 12-week open-label; 8-week double-blind,
placebo-controlled, randomized withdrawal study with a primary endpoint of change in Orthostatic Hypotension Symptom Assessment
(OHSA) composite score. The Company reiterates it expects the $25 million investment from Royalty Pharma to fund the majority
of the Phase 3 costs as a result of study size as well as insights and learnings from earlier studies.
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 with Viatris.
Sale of TRELEGY ELLIPTA Royalty Interest
July 20, 2022, Theravance Biopharma closed the sale of its units in Theravance Respiratory Company, LLC ("TRC, LLC") representing
its 85% economic interest in the sales-based royalty rights on worldwide net sales of GSK's TRELEGY ELLIPTA ("TRELEGY") to Royalty
Pharma (NASDAQ: RPRX) for over $1.5 billion in potential total value (the "TRELEGY Royalty Transaction"). The TRELEGY Royalty
Transaction is intended to provide near-, mid- and long-term value to the Company with an upfront cash payment of approximately $1.1 billion,
up to $250 million in additional milestone payments contingent on the achievement of certain TRELEGY net sales thresholds between 2023
and 2026 and outer year royalties to the Company.
Global Net Sales and Milestones
posted third quarter 2022 global net sales of $552 million (up from $449 million, or 23%,
from third quarter of 2021), and global net sales from the first nine months of 2022 have reached approximately $1.6 billion (up
from $1.2 billion, or 34% from the first nine months of 2021). Theravance Biopharma is entitled to a milestone payment from Royalty
Pharma of $50 million if TRELEGY global net sales are equal to or exceed $2.9 billion2 in
2023, the first of $250 million of potential milestones that can be achieved between 2023 - 2026.
The Company purchased all of GSK's equity stake in Theravance
Biopharma, consisting of approximately 9.6 million shares at $9.75 per share on September 20, 2022.
The Company announced a Dutch auction tender offer (the
"Offer") for up to $95 million of its ordinary shares on September 28, 2022.
The Company plans to enter into an Open Market Share Repurchase
Plan to facilitate the repurchase of approximately $60 million of its ordinary shares in open market purchases subsequent to the completion
of the Offer, with a goal to complete this program by the end of 2023.
Extension of the Offer
The Company is extending the length of the Offer such
that the Offer will expire at midnight, New York City time, at the end of the day on November 17, 2022, unless the Company extends
the Offer for an additional period of time. Based on information provided by Computershare Trust Company, N.A., the depositary for
the Offer, to date, approximately 95,487 shares have been validly tendered for purchase in the Offer. Shareholders who have validly
tendered and not withdrawn their shares do not need to re-tender their shares or take any other action in response to the extension
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%.
Third Quarter Financial Results
2022 Financial Guidance
Conference Call and Live Webcast Today at 5:00
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, 2022.
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). Its pipeline
of internally discovered programs is targeted to address significant unmet patient needs.
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 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: contingent payments due to the Company from the sale of the
Company's TRELEGY ELLIPTA royalty interests to Royalty Pharma, the Company's goals, designs, strategies, plans and objectives,
the 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,
including potential points of differentiation, the market for products being commercialized and product candidates, product sales or
profit share revenue and the Company's expectations for its future financial performance and
expectations as to future cash flows, the effectiveness of the Company's intellectual property portfolio, the timing of the
Offer, including the settlement thereof and the satisfaction of conditions to the Offer, and the Company's repurchase of its
ordinary shares by way of an open market share repurchase plan. 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 related to: whether the
milestone thresholds can be achieved, delays or difficulties in commencing, enrolling or completing clinical studies, the potential
that results from clinical or non-clinical studies indicate the Company's product candidates or product are unsafe, ineffective or
not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, 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, the ability of the Company to protect and to enforce its intellectual property rights, the satisfaction of the
conditions to the Offer, volatility and fluctuations in the trading price and volume of the Shares, and general economic and market
conditions. Other risks affecting Theravance Biopharma are in the Company's Form 10-Q filed with the SEC on August 8, 2022, and
other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the