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DUBLIN, Nov. 7, 2022 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today reported financial results for the third quarter of 2022.
"This quarter is a milestone in the Company's transformation and demonstrates the power of a team of people who are focused and stay true to the Company's purpose, delivering medicines that make a difference. I am proud and grateful for the team that has refocused the portfolio and monetized our interest in TRELEGY to reposition and reinvigorate the Company's business model. Theravance Biopharma today is debt free, and I believe we are well-positioned for value creation," said Rick E Winningham, Chief Executive Officer.
Quarterly Highlights
Third Quarter Financial Results
2022 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 / 10:00 pm GMT. To participate in the live call by telephone, please register here. 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 webcast will be available on Theravance Biopharma's website for 30 days through December 7, 2022.
About Theravance Biopharma
Theravance Biopharma, Inc.'s focus is to deliver 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 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 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: contingent payments due to the Company from the sale of the Company's TRELEGY ELLIPTA royalty interests to Royalty Pharma, the Company's goals, designs, strategies, plans and objectives, the 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, including potential points of differentiation, the market for products being commercialized and product candidates, product sales or profit share revenue and the Company's expectations for its future financial performance and expectations as to future cash flows, the effectiveness of the Company's intellectual property portfolio, the timing of the Offer, including the settlement thereof and the satisfaction of conditions to the Offer, and the Company's repurchase of its ordinary shares by way of an open market share repurchase plan. 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 or product 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 and others, the ability of the Company to protect and to enforce its intellectual property rights, the satisfaction of the conditions to the Offer, volatility and fluctuations in the trading price and volume of the Shares, and general economic and market conditions. Other risks affecting Theravance Biopharma are in the Company's Form 10-Q filed with the SEC on August 8, 2022, 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 law.
Important Information Regarding the Tender Offer
This press release is for informational purposes only and is neither an offer to buy nor the solicitation of an offer to sell any of the Company's ordinary shares, par value $0.00001 per share (the "Shares"). A Dutch auction tender offer (the "Offer") to purchase up to $95 million of the Shares is being made solely by the Company's Offer to Purchase, dated September 28, 2022, the related Letter of Transmittal and other related materials, as they may be amended or supplemented. Holders of Shares should read the Company's offer statement on Schedule TO filed with the SEC in connection with the Offer, which includes as exhibits the Offer to Purchase, the Letter of Transmittal and related materials, as well as any amendments or supplements to the Schedule TO when they become available, because they will contain important information. Each of these documents has been, or will be, filed with the SEC, and, when available, holders may obtain them for free from the SEC at its website ( www.sec.gov ) or from the information agent in connection with the Offer.
This press release does not set forth all of the terms and conditions of the Offer. Shareholders should carefully read the Offer to Purchase, the Letter of Transmittal and related materials, for a complete description of all terms and conditions before making any decision with respect to the Offer. None of the Company, its management, its board of directors, its officers, the dealer manager, the depositary, or the information agent, or any of their respective affiliates, makes any recommendation that holders tender or refrain from tendering all or any portion of their Shares, and no one has been authorized by any of them to make such a recommendation. Holders must make their own decision as to whether to tender their Shares and, if so, the amount of Shares to tender and the purchase price or prices at which to tender.
Contact: Andrew Hindman
Chief Financial Officer
investor.relations@theravance.com
650-808-4045
THERAVANCE BIOPHARMA, INC. | |||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||
(In thousands) | |||||
September 30, | December 31, | ||||
2022 | 2021 | ||||
Assets | (Unaudited) | (1) | |||
Current assets: | |||||
Cash and cash equivalents and short-term marketable securities | $ | 486,832 | $ | 173,465 | |
Receivables from collaborative arrangements | 14,114 | 14,065 | |||
Prepaid clinical and development services | 2,645 | 10,245 | |||
Other prepaid and current assets | 8,127 | 8,561 | |||
Current assets - Discontinued operations | - | 43,534 | |||
Total current assets | 511,718 | 249,870 | |||
Property and equipment, net | 11,884 | 13,657 | |||
Operating lease assets | 39,992 | 39,690 | |||
Future contingent milestone and royalty assets | 194,200 | - | |||
Restricted cash | 836 | 837 | |||
Other assets | 4,866 | 3,228 | |||
Non-current assets - Discontinued operations | - | 67,537 | |||
Total assets | $ | 763,496 | $ | 374,819 | |
Liabilities and Shareholders' Equity (Deficit) | |||||
Current liabilities - Continuing operations | $ | 21,582 | $ | 55,893 | |
Current liabilities - Discontinued operations: | |||||
Income tax payable | 120,550 | - | |||
Accrued interest payable on Non-recourse notes due 2035, net | - | 2,694 | |||
Non-Current liabilities - Continuing operations: | |||||
Long-term operating lease liabilities | 51,381 | 52,681 | |||
Future royalty payment contingency | 24,888 | - | |||
Unrecognized tax benefits | 62,661 | 240 | |||
Other long-term liabilities | 1,856 | 2,490 | |||
Non-recourse notes due 2035, net | - | 371,359 | |||
Convertible senior notes due 2023, net | - | 228,035 | |||
Shareholders' equity (deficit) | 480,578 | (338,573) | |||
Total liabilities and shareholders' equity (deficit) | $ | 763,496 | $ | 374,819 | |
________________________________ | |||||
(1) The condensed consolidated balance sheet as of December 31, 2021 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021. |
THERAVANCE BIOPHARMA, INC. | ||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||
(In thousands, except per share data) | ||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||
(Unaudited) | (Unaudited) | |||||||||||
Revenue: | ||||||||||||
Viatris collaboration agreement (1) | $ | 12,445 | $ | 10,397 | $ | 34,010 | $ | 31,716 | ||||
Collaboration revenue | 6 | 2,797 | 187 | 8,649 | ||||||||
Licensing revenue | - | - | 2,500 | - | ||||||||
Total revenue | 12,451 | 13,194 | 36,697 | 40,365 | ||||||||
Costs and expenses: | ||||||||||||
Research and development (2) | 9,867 | 43,739 | 48,691 | 162,431 | ||||||||
Selling, general and administrative (2) | 16,277 | 21,299 | 51,105 | 77,780 | ||||||||
Restructuring and related expenses (2) | 509 | 1,771 | 11,427 | 1,771 | ||||||||
Total costs and expenses | 26,653 | 66,809 | 111,223 | 241,982 | ||||||||
Loss from operations | (14,202) | (53,615) | (74,526) | (201,617) | ||||||||
Interest expense | (1,545) | (2,136) | (5,819) | (6,410) | ||||||||
Loss on extinguishment of debt | (3,034) | - | (3,034) | - | ||||||||
Interest income and other income (expense), net | 2,758 | (166) | 4,823 | 771 | ||||||||
Loss from continuing operations before income taxes | (16,023) | (55,917) | (78,556) | (207,256) | ||||||||
Provision for income tax benefit (expense) | - | 7 | (12) | - | ||||||||
Net loss from continuing operations | (16,023) | (55,910) | (78,568) | (207,256) | ||||||||
Income from discontinued operations before income taxes | 1,115,016 | 20,602 | 1,143,930 | 39,864 | ||||||||
Provision for income tax expense | (182,362) | - | (182,868) | - | ||||||||
Net income from discontinued operations | 932,654 | 20,602 | 961,062 | 39,864 | ||||||||
Net income (loss) | $ | 916,631 | $ | (35,308) | $ | 882,494 | $ | (167,392) | ||||
Net income (loss) per share: | ||||||||||||
Continuing operations - basic and diluted | $ | (0.21) | $ | (0.76) | $ | (1.04) | $ | (3.05) | ||||
Discontinued operations - basic and diluted | $ | 12.35 | $ | 0.28 | $ | 12.70 | $ | 0.59 | ||||
Net income (loss) - basic and diluted | $ | 12.14 | $ | (0.48) | $ | 11.66 | $ | (2.46) | ||||
Shares used in compute per share calculations - basic and diluted | 75,515 | 73,574 | 75,678 | 67,945 | ||||||||
________________________________ | ||||||||||||
(1) While Viatris, Inc. records the total YUPELRI net sales, the Company is entitled to a 35% share of the net profit (loss) pursuant to a co-promotion agreement with Viatris. The Company's implied 35% share of total YUPELRI net sales is presented below: | ||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
(In thousands) | 2022 | 2021 | 2022 | 2021 | ||||||||
YUPELRI net sales (implied 35%) | $ | 18,698 | $ | 13,806 | $ | 51,158 | $ | 41,334 | ||||
(2) Amounts include share-based compensation expense as follows: | ||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
(In thousands) | 2022 | 2021 | 2022 | 2021 | ||||||||
Research and development | $ | 2,623 | $ | 6,956 | $ | 10,709 | $ | 22,192 | ||||
Selling, general and administrative | 5,196 | 7,414 | 16,488 | 22,951 | ||||||||
Restructuring and related expenses | 711 | - | 5,587 | - | ||||||||
Total share-based compensation expense | $ | 8,530 | $ | 14,370 | $ | 32,784 | $ | 45,143 |
1 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 The first milestone payment of $50.0 million, will be triggered if Royalty Pharma receives $240.0 million or more in royalty payments from GSK with respect to 2023 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales reach approximately $2.863 billion. Royalties payable from GSK to Royalty Pharma are upward tiering from 6.5% to 10%.
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SOURCE Theravance Biopharma, Inc.