Full Press Release Details
Theravance Biopharma, Inc. Reports
Fourth Quarter and Full-Year 2019 Financial Results and Provides Business Update
- February 24, 2020 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today reported financial results for the fourth quarter and full year ended December 31, 2019. Revenue for
the fourth quarter and full year 2019 was $29.5 million and $73.4 million, respectively. Full-year operating loss was $251.9 million
or $191.5 million excluding share-based compensation expense. Cash, cash equivalents and marketable securities totaled $285.8 million
as of December 31, 2019.
Rick E Winningham, Chairman and Chief Executive
Officer, commented: "2019 was a year of achievement for Theravance Biopharma across our business. We successfully launched
YUPELRI with Mylan and advanced our development- and research-stage pipeline, further building a diversified portfolio with promising,
differentiated programs in every stage of development. Our roster of partnerships continued to strengthen, with ongoing successful
collaborations with Mylan for YUPELRI and Janssen for TD-1473 and TD-5202. In addition, we entered into a new agreement with Pfizer
to out-license our skin-selective pan-JAK inhibitor program. Our partnerships complement and expand our capabilities and execution
and underscore our potential to transform the treatment of serious diseases."
"As we look ahead, 2020 will be an important year for
our Company. We have established a strong capital position, augmented by our partnerships, as well as TRELEGY ELLIPTA royalties
and YUPELRI commercialization. We are optimistic about future data readouts, especially our wholly owned programs -- ampreloxetine
in nOH and TD-8236 in asthma -- which could both represent new treatment paradigms for patients with debilitating chronic diseases.
The combined strengths of our research engine, pipeline, proven development expertise and commercial infrastructure have set the
stage for a data- and catalyst-rich 2020 -- a year that we believe can deliver meaningful value for stakeholders."
Corporate Highlights
Partnered with Mylan:
YUPELRI (revefenacin) inhalation solution (lung-selective
nebulized long-acting muscarinic antagonist (LAMA)):
Partnered with Janssen:
TD-5202 (gut-selective irreversible JAK3 inhibitor for inflammatory
intestinal diseases):
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
| Part C extension portion of the Phase 1 trial assessing additional biomarkers in more severe asthmatics underway with results expected in mid-2020 | |
| Phase 2 lung allergen challenge initiated in 4Q 2019; data expected in mid-2020 |
TRELEGY ELLIPTA (first once-daily single
inhaler triple therapy for COPD)2:
| 4Q 2019 net sales of $221.5 million and full-year 2019 net sales of $661.3 million; Theravance Biopharma entitled to approximately 5.5% to 8.5% (tiered) of worldwide net sales of the product | |
| Product now launched for COPD in 38 markets, including China | |
| GSK filed sNDA 2Q 2019 for mortality benefit compared with ANORO in COPD and sNDA for use in patients with asthma in 3Q 2019 |
1 Theravance Biopharma's
full-year operating loss, excluding share-based compensation expense, was below the 2019 guidance of $200 million to $210 million
operating loss excluding share-based compensation due to the Pfizer upfront payment of $10 million being recognized as revenue
2 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 fiscal
quarters). 75% of the income from Company's investment in TRC is pledged to service outstanding PhaRMASM notes,
25% of income from Company's investment in TRC is retained by Company.
Fourth Quarter and Full Year Financial Results
2020 Financial Guidance
| Royalty income for TRELEGY ELLIPTA which the Company recognizes in its statement of operations as "income from investment in TRC, LLC;" or | ||
| Potential future business development collaborations |
timing and cost of clinical studies associated with key programs, among other factors, could impact financial guidance.
as announced on February 11th, 2020, we closed our public offering of 5,500,000 ordinary shares at a price to the public of
$27.00 per share. The gross proceeds to Theravance Biopharma from the offering are approximately $148.5 million, before deducting
underwriting discounts and commissions and estimated offering expenses.
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 (2:00 pm PT / 10:00 pm GMT). 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
5775588. 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.
A replay of the conference call will be
available on Theravance Biopharma's website for 30 days through March 25, 2020. An audio replay will also be available
through 8:00 pm ET on March 2, 2020 by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers,
and then entering confirmation code 5775588.
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
organ-selective expertise to biologically compelling targets to discover and develop medicines designed to treat underserved localized
diseases and to limit systemic exposure, in order to maximize patient benefit and minimize risk. 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). Our pipeline of internally discovered programs is targeted to address significant patient needs.
We have 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 ELLIPTA.
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 United States registered
trademark of Mylan Specialty L.P. 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, 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 2019 operating loss, excluding share-based compensation.
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: 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,