Full Press Release Details
Theravance Biopharma, Inc. Reports Third
Quarter 2019 Financial Results and Provides Business Update
clinical studies of ampreloxetine and gut-selective oral pan-JAK inhibitor TD-1473 progressing
inhaled pan-JAK inhibitor TD-8236 progressing to allergen challenge study
following positive Phase 1 results including
biomarker data in asthmatics
Continued strong customer acceptance of YUPELRI (revefenacin) inhalation solution, in
partnership with Mylan
Multiple data read-outs from key programs anticipated in 2020
Company reduces 2019 full-year operating loss guidance to a range of $200 million to $210
million, excluding non-cash share-based compensation
IRELAND - NOVEMBER 5, 2019 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today reported financial results for the third quarter ended September 30, 2019. Revenue for the third quarter of
2019 was $12.4 million. Third quarter operating loss was $65.2 million or $52.2 million excluding share-based compensation expense.
Cash, cash equivalents, marketable securities, and restricted cash totaled $352.9 million as of September 30, 2019.
Rick E Winningham, Chief Executive Officer,
"As we approach the end of 2019,
a critical year of progress for Theravance Biopharma, we believe that our organ-selective focus in research, translational science
and development has generated a portfolio of product candidates that have the potential to transform the treatment of serious,
chronic diseases. We have generated a compelling body of evidence attesting to the potential therapeutic value of organ-selective
medicines. These organ-selective medicines are directed at biological targets that cannot be fully leveraged systemically without
incurring serious dose-limiting toxicities. We have demonstrated the potential to maximize the value of proven and potent biology
to achieve greater efficacy, safety and enhanced outcomes for patients.
"2020 will be an important year for
our company in terms of delivering data across all of our key development programs: TD-1473, our gut-selective pan-JAK inhibitor,
is moving forward in a Phase 2b/3 study in ulcerative colitis and a Phase 2 study in Crohn's disease, partnered with Janssen;
ampreloxetine, our norepinephrine reuptake inhibitor, is advancing in a Phase 3 registrational program in symptomatic neurogenic
orthostatic hypotension (nOH); TD-8236, our lung-selective pan-JAK inhibitor for which we reported promising Phase 1 data, is planned
to be evaluated in additional asthma trials; and TD-5202, our gut-selective irreversible JAK3 inhibitor for inflammatory intestinal
diseases, is advancing in Phase 1.
"Regarding our commercial programs,
the YUPELRI U.S. launch is progressing well in partnership with Mylan and we continue to make headway against key
performance metrics. Lastly, we continue to be pleased by the commercial momentum of GSK's TRELEGY ELLIPTA.
"Looking ahead, we expect to achieve
important milestones over the next 12 to 18 months as we maintain a strong capital position, advance our promising pipeline, build
value through our partnerships and prioritize the commercialization of our innovation."
TD-1473 (gut-selective oral pan-Janus kinase
(JAK) inhibitor for inflammatory intestinal diseases):
Ampreloxetine (TD-9855, norepinephrine
reuptake inhibitor (NRI) for symptomatic nOH):
TD-8236 (lung-selective inhaled pan-JAK inhibitor for inflammatory
TD-5202 (gut-selective irreversible JAK3 inhibitor for inflammatory
intestinal diseases):
YUPELRI (revefenacin) inhalation solution (lung-selective
nebulized long-acting muscarinic antagonist (LAMA)):
TRELEGY ELLIPTA (first once-daily single
inhaler triple therapy for COPD)1:
1 As reported by Glaxo Group
Limited or one of its affiliates (GSK); reported sales converted to USD; economic interest related to TRELEGY ELLIPTA (the combination
of fluticasone furoate, aclidinium, and vilanterol, (FF/UMEC/VI), jointly developed by GSK and Innoviva, Inc.) entitles 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 LLC") expenses paid and the amount of cash, if any, expected to be used in TRC over the next four
Third Quarter Financial Results
Total revenue for the third quarter of
2019 was $12.4 million compared to $12.8 million in the same period in 2018. The decrease was primarily due to a decrease in product
sales which resulted from the sale of VIBATIV to Cumberland Pharmaceuticals in late-2018, mostly offset by revenue
from the Mylan collaboration agreement for YUPELRI .
Research and Development (R&D) Expenses
R&D expenses for the third quarter
of 2019 were $52.0 million, compared to $52.7 million in the same period in 2018. The decrease was primarily due to lower employee-related
costs associated with the reduction in force announced in the first quarter of 2019, partially offset by an increase in external
expenses related to the progression of our key programs. Third quarter R&D expenses included non-cash share-based compensation
Selling, General and Administrative
SG&A expenses for the third quarter
of 2019 were $25.6 million, compared to $21.9 million in the same period in 2018. The increase was primarily due to higher
external expenses and share-based compensation, partially offset by lower employee-related costs associated with the reduction
in force announced in the first quarter of 2019. Third quarter SG&A expenses included non-cash share-based compensation of
Cash, Cash Equivalents and Marketable
Cash, cash equivalents, marketable securities,
and restricted cash, totaled $352.9 million as of September 30, 2019.
2019 Financial Guidance
Company has reduced its 2019 full year operating loss guidance to a range of $200.0 million to $210.0 million, excluding
non-cash share-based compensation. The reduction in operating loss guidance is primarily due to additional licensing revenue recognized
in the second quarter of 2019 associated with the upfront payment received from Mylan for YUPELRI development and commercialization
rights in China. Operating loss guidance does not include royalty income for TRELEGY ELLIPTA
which the Company recognizes as non-operating income. Our future financial guidance could be impacted by factors including, but
not limited to our share of U.S. profits and losses related to the commercialization of YUPELRI, potential future business development
collaborations as well as the timing and cost of clinical studies associated with its key programs.
Arbitration Against Innoviva
in the Company's filings with the Securities and Exchange Commission, in May 2019, the Company announced that it had initiated
an arbitration against Innoviva, Inc. and Theravance Respiratory Company, LLC. As further reported in a Form 8-K filed by the Company
on September 30, 2019, the arbitrator issued a final decision.
Conference Call and Live Webcast Today
Theravance Biopharma will hold a conference
call and live webcast accompanied by slides today at 5:00 pm ET. To participate in the live call by telephone, please dial (855)
296-9648 from the US, or (920) 663-6266 for international callers, and use the confirmation code 6281636. 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 Investor Relations section, Presentations and Events. Please go to the website 15 minutes prior to the start of the
call to register, download, and install any necessary audio software.
A replay of the conference call will be
available on Theravance Biopharma's website for 30 days through December 5, 2019. An audio replay will also be available
through 11:00 am ET on November 12, 2019 by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers,
and then entering confirmation code 6281636.
About Theravance Biopharma
Theravance Biopharma, Inc. ("Theravance
Biopharma") is a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization
of organ-selective medicines. Our purpose is to create transformational medicines to improve the lives of patients suffering from
serious illnesses. Our research is focused in the areas of inflammation and immunology.
In pursuit of our purpose, we apply insights
and innovation at each stage of our business and utilize our internal capabilities and those of partners around the world. We apply