Umeclidinium Bromide/Vilanterol Trifenatate

BURLINGAME, Calif.--( BUSINESS WIRE )--Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today reported financial results for the second quarter ended June 30, 2024, and highlighted select corporate achievements. “ Our robust second quarter continues to demonstrate the successful transformation of Innoviva. We have strong performance across multiple fronts, driven by our core GSK royalties portfolio and accelerating growth from our commercial products, GIAPREZA ® , XACDURO ® and XERAVA ® ,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “ We remain committed to enhancing shareholder value through thoughtful capital allocation and operational excellence. We also are excited about our portfolio of strategic healthcare assets, where we continue to see potential for significant value creation.” Mr. Raifeld added, “ In addition to driving strong operational delivery from our critical care and infectious disease platform IST, we continue to expand its global footprint and enhance recognition. Our partner in China, Zai Lab, successfully obtained regulatory approval for XACDURO ® , bringing us closer to making XACDURO ® available to all patients globally. In the U.S, important treatment guidelines and guidance updates recognized our key products, underscoring their life-saving potential. XACDURO ® was named the preferred agent for treatment of Carbapenem-resistant Acinetobacter baumannii infections in the 2024 Infectious Diseases Society of America (IDSA) treatment guidance. XERAVA ® is recommended by the 2024 Surgical Infection Society (SIS) treatment guidelines for empiric therapy in the management of complicated intra-abdominal infection.” Financial Highlights Royalty revenue: Second quarter 2024 gross royalty revenue from Glaxo Group Limited (“GSK”) was $67.2 million, compared to $65.7 million for the second quarter 2023. Net Product Sales: Second quarter 2024 net product sales were $21.7 million, which included $13.1 million from GIAPREZA ® , $6.2 million from XERAVA ® , and $2.4 million from XACDURO ® , a 38% increase compared to $15.7 million for the second quarter 2023. License Revenue: Second quarter 2024 license revenue of $14.5 million included an $8 million milestone payment from our partner for the regulatory approval of XACDURO ® in China and $6.5 million in non-recurring cost-sharing reimbursements from our partner for product development. Equity and long-term investments: Second quarter 2024 net unfavorable change in fair values of equity and long-term investments of $90.7 million was primarily attributable to lower share price of Armata Pharmaceuticals (“Armata”), despite continued operational progress. Net income: The change in fair values of our investments negatively impacted second quarter 2024 earnings, resulting in a net loss of $34.7 million, or ($0.55) basic per share, compared to a net income of $1.3 million, or $0.02 basic per share, for the second quarter of 2023. Share repurchases: During the second quarter 2024, Innoviva completed its $100 million share repurchase program by repurchasing 0.4 million shares, for a total amount of approximately $5.3 million. Cash and cash equivalents: Totaled $217.0 million. Royalty and net product sales receivables totaled $94.0 million as of June 30, 2024. Key Business and R&D Highlights XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use: targeted antibacterial for the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii calcoaceticus complex . In May 2024, XACDURO ® was approved in China by the National Medical Products Administration (NMPA) for use in Chinese patients 18 years of age and older. In July 2024, XACDURO ® was named as the preferred agent for the treatment of Carbapenem-resistant Acinetobacter baumannii infections, in combination with a carbapenem, in the updated 2024 IDSA treatment guidance. The World Health Organization considers Acinetobacter a top-priority pathogen worldwide that needs novel antibiotics 1 . XERAVA ® (eravacycline), for injection is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible microorganisms in patients 18 years or older. In July 2024, XERAVA ® was named as a recommended agent for empiric therapy in the updated 2024 SIS treatment guidelines for the management of complicated intra-abdominal infections. SIS also recommended XERAVA ® be reserved for high-risk patients. Zoliflodacin: a potential first-in-class, single dose, oral antibiotic in development for the treatment of patients with uncomplicated gonorrhea is currently being developed in partnership with The Global Antibiotic Research & Development Partnership (GARDP). Zoliflodacin has successfully completed Phase 3 clinical trials and the results were reported at ESCMID Global 2024. The Company expects to submit an NDA to the U.S. FDA in early 2025. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ® . Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA ® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. ANORO ® , RELVAR ® and BREO ® are trademarks of the GSK group of companies. Forward Looking Statements This press release contains 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, and future events. Innoviva 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. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva 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: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR ® /BREO ® ELLIPTA ® , ANORO ® ELLIPTA ® , GIAPREZA ® , XERAVA ® and XACDURO ® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (“COVID-19”); the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company’s growth strategy. Other risks affecting Innoviva are described under the headings “Risk Factors” and “ Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2023 and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at www.sec.gov . Past performance is not necessarily indicative of future 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. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. References (1) Tala, B., Jad, A., Claude, A., Jihad, I., Chantal, L., Rakan, N.,& Eid, A. (2017). Risk Factors, Clinical Presentation, and Outcome of Acinetobacter baumannii Bacteremia. Front. Cell. Infect. Microbiol., 04 May 2017, Sec. Molecular Bacterial Pathogenesis Volume 7 – 2017: https://doi.org/10.3389/fcimb.2017.00156 INNOVIVA, INC. Condensed Consolidated Statements of Income and Comprehensive Income (in thousands, except per share data) (unaudited) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Revenue: Royalty revenue, net (1) $ 63,742 $ 62,265 $ 122,157 $ 119,123 Net product sales 21,651 15,727 40,735 27,241 License revenue 14,505 3,000 14,505 11,000 Total revenue 99,898 80,992 177,397 157,364 Expenses: Cost of products sold (inclusive of amortization of inventory fair value adjustments) 8,472 8,979 19,443 17,728 Cost of license revenue - - - 1,600 Selling, general and administrative 27,740 23,542 58,145 43,277 Research and development 2,560 14,989 6,438 27,577 Amortization of acquired intangible assets 6,440 4,958 12,880 8,763 Changes in fair values of equity method investments, net 60,108 19,911 24,766 4,094 Changes in fair values of equity and long-term investments, net 30,556 83 43,891 2,247 Interest and dividend income (3,474 ) (3,553 ) (7,873 ) (6,918 ) Interest expense 5,802 4,382 11,653 8,809 Other expense, net 973 1,896 2,209 3,242 Total expenses, net 139,177 75,187 171,552 110,419 Income (loss) before income taxes (39,279 ) 5,805 5,845 46,945 Income tax expense (benefit), net (4,594 ) 4,525 3,998 10,800 Net income (loss) and comprehensive income (loss) $ (34,685 ) $ 1,280 $ 1,847 $ 36,145 Net income (loss) per share Basic $ (0.55 ) $ 0.02 $ 0.03 $ 0.54 Diluted $ (0.55 ) $ 0.02 $ 0.03 $ 0.46 Shares used to compute net income (loss) per share Basic 62,526 65,341 62,856 66,557 Diluted 62,526 65,489 63,064 88,175 (1) Total net revenue is comprised of the following (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 (unaudited) (unaudited) Royalties $ 67,198 $ 65,721 $ 129,069 $ 126,035 Amortization of capitalized fees (3,456 ) (3,456 ) (6,912 ) (6,912 ) Royalty revenue, net $ 63,742 $ 62,265 $ 122,157 $ 119,123 INNOVIVA, INC. Condensed Consolidated Balance Sheets (in thousands) (unaudited) June 30, December 31, 2024 2023 Assets Cash and cash equivalents $ 217,003 $ 193,513 Royalty and product sale receivables 93,980 84,075 Inventory 36,664 40,737 Prepaid expense and other current assets 10,630 25,894 Property and equipment, net 427 483 Equity and long-term investments 536,435 560,978 Capitalized fees paid, net 76,872 83,784 Right-of-use assets 3,118 2,536 Goodwill 17,905 17,905 Intangible assets 217,455 230,335 Deferred tax asset, net 11,446 - Other assets 2,982 3,267 Total assets $ 1,224,917 $ 1,243,507 Liabilities and stockholders’ equity Other current liabilities $ 23,929 $ 33,435 Accrued interest payable 3,422 3,422 Deferred revenue 855 1,277 Convertible senior notes, due 2025, net 191,659 191,295 Convertible senior notes, due 2028, net 255,623 254,939 Other long-term liabilities 72,065 71,870 Deferred tax liabilities, net - 563 Income tax payable, long-term 11,849 11,751 Innoviva stockholders’ equity 665,515 674,955 Total liabilities and stockholders’ equity $ 1,224,917 $ 1,243,507 INNOVIVA, INC. Cash Flows Summary (in thousands) (unaudited) Six Months Ended June 30, 2024 2023 Net cash provided by operating activities $ 80,765 $ 63,866 Net cash used in investing activities (43,038 ) (35,722 ) Net cash used in financing activities (14,237 ) (146,168 ) Net change $ 23,490 $ (118,024 ) Cash and cash equivalents at beginning of period 193,513 291,049 Cash and cash equivalents at end of period $ 217,003 $ 173,025

The European Medicines Agency (EMA) has granted approval to Sanofi and Regeneron's blockbuster biologic Dupixent (dupilumab) as the first-ever targeted therapy in the EU for adults with uncontrolled chronic obstructive pulmonary disease (COPD) marked by raised blood eosinophils. The EU approval is based on two landmark phase 3 studies demonstrating significant reductions in exacerbations, improved lung function, and enhanced health-related quality of life for patients. The EMA's decision makes Dupixent the first new treatment approach for COPD in over a decade, offering a new option for approximately 220,000 adults in the European Union. Dupixent's approval is specifically for patients who are already on a combination of inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on LABA and LAMA if ICS is not suitable. The phase 3 BOREAS and NOTUS studies, which supported the approval, showed that patients treated with Dupixent experienced a 30-34% reduction in annual moderate or severe COPD exacerbations and significant improvements in lung function and quality of life. The approval marks the sixth indication for Dupixent in the EU and the seventh globally. With additional regulatory submissions under review in the U.S., China, Japan, and other countries, Dupixent's approval in the EU could pave the way for broader global access. In the U.S., the FDA delayed the review for a label expansion of Dupixent in COPD back in May. According to Sanofi, the agency had requested additional efficacy analyses from the BOREAS and NOTUS pivotal trials, which were submitted in May. The agency determined this information constituted a major amendment to the sBLA, extending the PDUFA date to September 27, 2024. Also in May, Sanofi presented data from the phase 3 NOTUS study at the 2024 American Thoracic Society International Conference, confirming the positive results from the phase 3 BOREAS study. Sanofi and Regeneron remain confident that the additional analyses support the approval of Dupixent in COPD and are committed to working with the FDA. Now a top seller for both Sanofi and Regeneron, Dupixent was first approved in 2017 for eczema. It has since received subsequent approvals in asthma, rhinosinusitis, prurigo nodularis and eosinophilic esophagitis, including pediatric approvals in eczema and eosinophilic esophagitis .