Full Press Release Details
Theravance Biopharma to Sell TRELEGY
ELLIPTA Royalty Interests to Royalty Pharma for Approximately $1.1 Billion in Upfront Cash with Over $1.5 Billion in Potential Total
DUBLIN - July 13, 2022 - Theravance Biopharma, Inc.
("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced it has entered into a definitive
agreement to sell all of its units in Theravance Respiratory Company, 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 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 providing an opportunity to receive an estimated NPV of approximately $200 million.1
Immediately after announcing the TRELEGY Royalty Transaction, Theravance Biopharma intends to initiate a multi-step process to eliminate its outstanding debt and return capital to
shareholders. This process is expected to include:
After paying down the debt, estimated taxes and transaction expenses,
the Company estimates having approximately $430 million of cash on its balance sheet.
At the completion of this process, Theravance Biopharma expects
to be well-capitalized with a streamlined and debt-free balance sheet. The Company now anticipates it will approach breakeven cash
flow in the second half of 2022 without the cash flows from its interest in TRELEGY royalties, driven by disciplined spending within R&D
and the growth of YUPELRI .
1 85% of TRELEGY royalties return to Theravance Biopharma
beginning July 1, 2029 for sales ex-U.S., and January 1, 2031 for sales within the U.S. Net present value ("NPV") of royalties
based on GSK Bloomberg Consensus for TRELEGY through 2032 for U.S. sales and through 2034 for ex-U.S. sales, discounted at 7%. Ex-U.S.
sales for 2033-2034 extrapolated by Management due to limitation of consensus beyond 2032.
In addition, Royalty Pharma's investment in ampreloxetine validates
its potential as a therapy to manage symptomatic neurogenic orthostatic hypotension (nOH) in MSA patients. Royalty Pharma's $40
million investment in ampreloxetine includes a $25 million upfront payment and an additional $15 million payment upon the first regulatory
approval of ampreloxetine2. In exchange, Royalty Pharma will receive future unsecured royalties of 2.5% on annual global
net sales up to $500 million and 4.5% on annual global net sales over $500 million.
"Royalty Pharma is an
industry leader in identifying world class therapeutics and structuring creative financing transactions that support innovative
biopharma companies holding royalty interests. We believe this transaction for TRELEGY royalties delivers on the strategic value of
our economic interest in this important therapy for COPD and asthma patients," said Rick E Winningham, Theravance
Biopharma's Chairman and Chief Executive Officer. "This transaction underscores our commitment to maximize shareholder
value by eliminating debt, accelerating the return of capital to shareholders and strengthening our position as a biopharmaceutical
leader. Moreover, Royalty Pharma's additional investment in ampreloxetine supports the value-creating potential of this
promising therapy for MSA patients. It's our firm belief that, upon closing this transaction, Theravance Biopharma will
operate from a position of financial strength and will maintain its focus on YUPELRI's continued U.S. commercial
"This transaction reflects
our confidence in the significant value that TRELEGY delivers as a triple-combination therapy for COPD and asthma
patients, and GSK's continued global commercial excellence," said Pablo Legorreta, founder
and Chief Executive Officer of Royalty Pharma. "This transaction highlights our ability to provide capital at scale and
structure creative funding solutions, allowing Theravance to pursue important strategic initiatives, including the
advancement of their internally-discovered, late-stage therapeutic ampreloxetine."
Theravance Biopharma will continue to
pursue its overarching purpose and goals as a biopharmaceutical company focused on delivering Medicines that Make a Difference
building on its co-commercial efforts of YUPELRI , a measured investment in the Company's respiratory portfolio and
a focused effort to bring ampreloxetine to the MSA community. The Company expects to initiate the Phase 3 clinical trial with ampreloxetine
in early 2023 and to share additional details regarding the clinical study later this year. With recent guidance from the U.S. Food and
Drug Administration (FDA) in a Type C meeting on key study design elements and alignment on a path to a New Drug Application (NDA) filing,
Theravance Biopharma will conduct one new study in patients with MSA and expects the $25 million investment to fund the majority of the
The transaction with Royalty Pharma is subject to certain limited closing
conditions and is expected to close up to ten business days after the date of this press release, concurrently with the repayment of the
non-recourse TRELEGY notes referenced above.
2 Such approval to be from either the U.S. Food and Drug
Administration or the first of the European Medicines Agency or all four of Germany, France, Italy and Spain.
Evercore and MTS Partners acted as financial advisors and Skadden,
Arps, Slate, Meagher & Flom LLP acted as legal advisor to Theravance Biopharma. Goodwin Procter acted as legal advisor to Royalty
Conference Call and Live Webcast Today at 5:00 pm ET
Theravance 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 IST. To participate in the live call by telephone, please dial (800) 225-9448 from the U.S., or (203) 518-9708 for international callers, using the confirmation code TBPH0713. 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 conference call will be available on Theravance Biopharma's
website for 30 days through August 12, 2022. An audio replay will also be available through 11:59 pm ET on July 20, 2022, by dialing (800) 839-2485 from the U.S., or (402) 220-7222
for international callers.
About Theravance Biopharma
Theravance Biopharma, Inc.'s overarching purpose and goal
as a biopharmaceutical company is focused on delivering 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
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.
TRELEGY and ELLIPTA are trademarks of the GSK group of
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, as amended, and the Private
Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the expected closing of the
transaction and the timing thereof, the Company's goals, designs, strategies, plans and objectives, the impact of the
Company's restructuring plan, ability to provide value to shareholders, the timing of clinical studies, the potential that the
Company's research programs will progress product candidates into the clinic, the Company's expectations regarding its allocation of
resources, potential regulatory actions, product sales or profit share revenue and the Company's expectations for its future
financial performance and expectations as to future cash flows. 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 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