Full Press Release Details
Theravance Biopharma, Inc. Reports Second
Quarter 2021 Financial Results and Provides Business Update
- AUGUST 3, 2021 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today reported financial results for the second quarter of 2021.
"We made strong progress in the second
quarter. Our field team is energized and has recently been able to increase its face-to-face engagements with customers, driving continued
sales volume and market share growth. As we look to the future for YUPELRI, we and our partner Viatris are initiating a controlled clinical
study intended to provide data for a possible label update," said Rick E Winningham, Chief Executive Officer. "We continued
to execute across our clinical trials and eagerly anticipate study results this quarter and later this year/early next. 2021 is a
pivotal year for Theravance Biopharma, and we are looking forward to the second half of the year furthering our mission of medicines that
Upcoming Clinical Milestones
Quarterly Highlights
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.
As reported by Glaxo Group Limited or one of its affiliates (GSK); reported sales converted to USD; economic interest related to TRELEGY
(the combination of fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI), jointly developed by GSK and Innoviva, Inc.) entitles
the 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) 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 the Company's investment in TRC is pledged to service outstanding notes and 25% of income from the Company's
investment in TRC is retained by the Company.
Second Quarter Financial Results
As reported by Glaxo Group Limited or one of its affiliates (GSK); reported sales converted to USD; economic interest related to
TRELEGY (the combination of fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI), jointly developed by GSK and Innoviva,
Inc.) entitles the 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) 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 the Company's investment in TRC is pledged to service outstanding notes and 25%
of income from the Company's investment in TRC is retained by the Company.
2021 Financial Guidance
Conference Call and Live Webcast Today at 5 pm ET
Theravance Biopharma will hold a conference
call and live webcast accompanied by slides today at 5 pm ET / 2 pm PT / 10 pm IST. To participate, please dial (855) 296-9648
from the U.S. or (920) 663-6266 for international callers, using the confirmation code 2615108. Those interested in listening to the conference
call live via the internet may do so by visiting www.theravance.com, under the Investors section, Presentations and Events.
available on www.theravance.com for 30 days through September 2, 2021. An audio replay will also be available through 8:00
p.m. ET on August 10, 2021, by dialing (855) 859-2056 from the U.S., or (404) 537-2406 for international callers, and then entering
confirmation code 2615108.
About Theravance Biopharma
Theravance Biopharma, Inc. is a diversified
biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines. Its purpose
is to pioneer a new generation of small molecule drugs designed to better meet patient needs. Its research is focused in the areas of
inflammation and immunology.
In pursuit of its purpose, Theravance Biopharma
applies insights and innovation at each stage of its business and utilizes its internal capabilities and those of partners around the
world. The Company applies organ-selective expertise to target disease biologically, to discover and develop medicines that may expand
the therapeutic index with the goal of maximizing efficacy and limiting systemic side effects. 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). Its pipeline of internally
discovered programs is targeted to address significant patient 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 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, the Company's expectations regarding its allocation of resources, 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 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 or product candidates are unsafe, ineffective or not differentiated, risks that product candidates do
not obtain approval from regulatory authorities, the feasibility of undertaking future clinical trials for our product candidates 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. 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 May 6, 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
Contact: Gail B. Cohen
Corporate Communications
THERAVANCE BIOPHARMA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (Unaudited) | (1) | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents and short-term marketable securities | $ | 264,953 | $ | 292,941 | ||||
| Receivables from collaborative arrangements | 12,220 | 15,868 | ||||||
| Amounts due from TRC, LLC | 27,741 | 53,799 | ||||||
| Prepaid clinical and development services | 15,913 | 20,374 | ||||||
| Other prepaid and current assets | 12,353 | 10,359 | ||||||
| Total current assets | 333,180 | 393,341 | ||||||
| Property and equipment, net | 16,583 | 16,422 | ||||||
| Operating lease assets | 41,508 | 43,260 | ||||||
| Equity in net assets of TRC, LLC | 35,822 | 12,750 | ||||||
| Restricted cash | 833 | 833 | ||||||
| Other assets | 1,325 | 2,451 | ||||||
| Total assets | $ | 429,251 | $ | 469,057 | ||||
| Liabilities and Shareholders' Deficit | ||||||||
| Current liabilities | $ | 67,127 | $ | 123,571 | ||||
| Convertible senior notes due 2023, net | 227,499 | 226,963 | ||||||
| Non-recourse notes due 2035, net | 375,069 | 372,873 | ||||||
| Long-term operating lease liabilities | 57,768 | 47,220 | ||||||
| Other long-term liabilities | 2,162 | 2,181 | ||||||
| Shareholders' deficit | (300,374 | ) | (303,751 | ) | ||||
| Total liabilities and shareholders' deficit | $ | 429,251 | $ | 469,057 |
THERAVANCE BIOPHARMA, INC.