Full Press Release Details
Theravance Biopharma, Inc. Reports Third Quarter
2021 Financial Results and Provides Business Update
IRELAND - November 3, 2021 - Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company")
(NASDAQ: TBPH) today reported financial results for the third quarter of 2021.
"This last month has been about executing
on our strategy to create a new Theravance Biopharma, focused on leveraging expertise in developing and commercializing respiratory therapeutics.
We are executing against the strategic plan we announced in mid-September to become cash-flow positive by the second-half of 2022,"
said Rick E Winningham, Chief Executive Officer. "We are on track to reduce headcount by approximately 75% with the large majority
of staff departing by the end of November and the remainder by the end of February. Our focus is driving growth of YUPELRI, streamlining
R&D investment and optimizing our asset portfolio to maximize shareholder value."
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.
2 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.
Upcoming Clinical Milestones
Third Quarter Financial Results
3 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 by 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 5:00 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 / 9:00 pm GMT. To participate, please dial (855) 296-9648 from the US, or (920)
663-6266 for international callers, using the confirmation code 9772385. 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.
A replay will be available on www.theravance.com
for 30 days through December 3, 2021. An audio replay will also be available through 7:00 pm ET on November 10, 2021, by dialing (855)
859-2056 from the US, or (404) 537-2406 for international callers, and then entering confirmation code 9772385.
About Theravance Biopharma
Theravance Biopharma, Inc. is a biopharmaceutical company primarily
focused on the discovery, development and commercialization of respiratory medicines. Its core purpose is to create medicines that help
improve the lives of patients suffering from respiratory illness.
In pursuit of its purpose, Theravance Biopharma leverages decades
of respiratory expertise to discover and develop transformational medicines that make a difference. These efforts have 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 respiratory pipeline of internally discovered programs is targeted to address significant
patient respiratory 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 US 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.
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 impact of the Company's restructuring plan, 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, the potential that the Company's research programs will progress product
candidates into the clinic, the Company's expectations for product candidates through development and the market for products being
commercialized, the Company's expectations regarding its allocation of resources, potential regulatory actions and commercialization
(including differentiation from other products or potential products and addressable market), 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, products or product candidates are
unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, the
feasibility of undertaking future clinical trials 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, ability to retain key personnel, the impact of the Company's restructuring actions on its employees, partners
and others. 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, 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 August 5, 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 as required by
Contact: Gail B. Cohen
Corporate Communications / 917-214-6603
| THERAVANCE BIOPHARMA, INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands) | ||||||||
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (Unaudited) | (1) | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents and short-term marketable securities | $ | 216,213 | $ | 292,941 | ||||
| Receivables from collaborative arrangements | 14,001 | 15,868 | ||||||
| Amounts due from TRC, LLC | 43,773 | 53,799 | ||||||
| Prepaid clinical and development services | 13,242 | 20,374 | ||||||
| Other prepaid and current assets | 9,943 | 10,359 | ||||||
| Total current assets | 297,172 | 393,341 | ||||||
| Property and equipment, net | 16,003 | 16,422 | ||||||
| Operating lease assets | 40,718 | 43,260 | ||||||
| Equity in net assets of TRC, LLC | 45,086 | 12,750 | ||||||
| Restricted cash | 833 | 833 | ||||||
| Other assets | 3,297 | 2,451 | ||||||
| Total assets | $ | 403,109 | $ | 469,057 | ||||
| Liabilities and Shareholders' Deficit | ||||||||
| Current liabilities | $ | 66,082 | $ | 123,571 | ||||
| Convertible senior notes due 2023, net | 227,767 | 226,963 | ||||||
| Non-recourse notes due 2035, net | 375,570 | 372,873 | ||||||
| Long-term operating lease liabilities | 54,353 | 47,220 | ||||||
| Other long-term liabilities | 2,929 | 2,181 | ||||||
| Shareholders' deficit | (323,592 | ) | (303,751 | ) | ||||
| Total liabilities and shareholders' deficit | $ | 403,109 | $ | 469,057 |