Zoliflodacin

Generated $58.6 million in revenue from resilient royalties portfolio Achieved IST U.S. net product sales of $34.2 million for the first quarter, representing 29% year-over-year growth Significant value created across strategic healthcare asset portfolio BURLINGAME, Calif.--(BUSINESS WIRE)--Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified biopharmaceutical 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 first quarter ended March 31, 2026, and highlighted select corporate progress and achievements. “We delivered a strong start to 2026, driven by the resilience of our royalty portfolio, continued excellent commercial progress at IST, and meaningful value creation across our strategic healthcare assets,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “IST achieved 37% year-over-year net product sales growth in the first quarter of 2026, including 29% growth in U.S. sales.” “We also remained active in executing our capital allocation priorities, including increased activity under our $125 million share repurchase program, underscoring our confidence in Innoviva’s long-term value proposition. Innoviva’s strong track record across its operating and strategic healthcare assets, coupled with significant cash resources and durable royalty inflows, positions us well for accretive capital deployment and long-term shareholder value creation throughout variable market environments,” concluded Mr. Raifeld. Financial Highlights for the First Quarter of 2026 Total revenue: $98.0 million, yielding 11% growth compared to $88.6 million for the first quarter 2025. Royalty revenue: gross royalty revenue from Glaxo Group Limited (“GSK”) was $58.6 million, compared to $61.3 million for the first quarter 2025. Net product sales: $41.4 million ($34.2 million U.S. and $7.2 million ex-US), representing 37% growth compared to $30.3 million in the same quarter of 2025. U.S. net product sales primarily consisted of $19.7 million from GIAPREZA ® , $11.6 million from XACDURO ® , and $2.5 million from XERAVA ® . Income from operations: $38.2 million, compared to $41.4 million for the first quarter 2025, reflecting continued investment in commercial activities, as well as product and business development. Equity and long-term investments: net favorable changes in fair value of equity and long-term investments totaled $191.2 million, primarily attributable to share price appreciation of Armata Pharmaceuticals. Innoviva’s strategic healthcare investments were valued at $773.3 million as of March 31, 2026, and consisted of $603.4 million in Armata Pharmaceuticals, $138.2 million in other strategic equity and convertible debt, and $31.7 million held by ISP Fund. Net income: $186.6 million ($2.52 basic earnings per share) was driven primarily by higher revenue and the positive impact of changes in the fair values of equity and long-term investments. Cash and cash equivalents: Totaled $603.1 million. Royalty and net product sales receivables totaled $92.6 million as of March 31, 2026. Key Business and R&D Highlights NUZOLVENCE ® (zoliflodacin): a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years and older weighing at least 35kg, developed in partnership with The Global Antibiotic Research & Development Partnership ("GARDP"). In December 2025, IST received U.S. Food and Drug Administration (FDA) approval of NUZOLVENCE ® , one of the first new treatments approved by the FDA for uncomplicated urogenital gonorrhea in nearly two decades. The Company remains on track to make NUZOLVENCE ® available to patients in the second half of 2026. Strategic healthcare assets Innoviva’s strategic healthcare asset portfolio experienced meaningful growth this quarter, including notable value crystallization at Armata Pharmaceuticals. Innoviva remains focused on disciplined capital deployment across healthcare opportunities where it believes its strategic perspective and operating experience can support long-term sustained returns. Capital Allocation During the first quarter of 2026, Innoviva repurchased 971,066 shares for $20.4 million under its $125 million share repurchase program. Since inception, and through the end of this quarter, the Company has repurchased 1,198,921 shares for $25.0 million, reflecting the Company’s continued confidence in its intrinsic value and long-term outlook. About Innoviva Innoviva is a diversified biopharmaceutical 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 critical care and infectious disease assets under the IST platform include GIAPREZA ® (angiotensin II) for increasing blood pressure in adults with septic or other distributive shock, XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus , XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults, ZEVTERA (ceftobiprole), an advanced-generation cephalosporin antibiotic licensed from Basilea Pharmaceutica International Ltd, Allschwil, and NUZOLVENCE ® (zoliflodacin), approved by the FDA for the oral treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years of age and older weighing at least 35 kg. For more information about Innoviva, go to . For information about Innoviva Specialty Therapeutics, go to . ANORO ® , RELVAR ® and BREO ® are trademarks of the GSK group of companies. ZEVTERA is a trademark of Basilea Pharmaceutica Ltd, Allschwil. 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 ® , XACDURO ® , ZEVTERA ® and NUZOLVENCE ® 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 development of the LYNX ® platform; 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 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, 2025 and Quarterly Reports on Form 10-Q, which are on the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at . 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. INNOVIVA, INC. Condensed Consolidated Statements of Income (in thousands, except per share data) (Unaudited) Three Months Ended March 31, 2026 2025 Revenue: Royalty revenue, net (1) $ 55,167 $ 57,807 Net product sales 41,371 30,279 License and other revenue 1,456 546 Total revenue 97,994 88,632 Cost of products sold (inclusive of amortization of inventory fair value adjustments) 15,607 8,842 Amortization of acquired intangible assets 6,554 6,475 Gross profit 75,833 73,315 Operating expenses: Selling, general and administrative 32,438 27,491 Research and development 5,241 4,396 Total operating expenses 37,679 31,887 Income from operations 38,154 41,428 Changes in fair values of equity method investments, net 157,650 (13,549 ) Changes in fair values of equity and long-term investments, net 33,575 (65,299 ) Interest and dividend income 10,987 4,538 Interest expense (5,437 ) (4,711 ) Other expense, net (366 ) (996 ) Income (loss) before income taxes 234,563 (38,589 ) Income tax expense (47,968 ) (7,995 ) Net income (loss) $ 186,595 $ (46,584 ) Net income (loss) per share: Basic $ 2.52 $ (0.74 ) Diluted $ 2.22 $ (0.74 ) Shares used to compute net income (loss) per share: Basic 74,160 62,709 Diluted 84,849 62,709 (1) Total net revenue is comprised of the following (in thousands): Three Months Ended March 31, 2026 2025 (unaudited) Royalties $ 58,623 $ 61,263 Amortization of capitalized fees (3,456 ) (3,456 ) Royalty revenue, net $ 55,167 $ 57,807 INNOVIVA, INC. Condensed Consolidated Balance Sheets (in thousands) (unaudited) March 31, December 31, 2026 2025 Assets Cash and cash equivalents $ 603,085 $ 550,941 Royalty and product sale receivables 92,628 93,317 Inventory 38,843 39,172 Prepaid expense and other current assets 29,221 28,358 Current portion of ISP Fund investments 8,846 15,727 Property and equipment, net 2,142 1,555 Equity method and equity and long-term investments 764,454 598,223 Capitalized fees 52,682 56,138 Right-of-use assets 10,652 10,929 Goodwill 17,905 17,905 Intangible assets 175,602 182,156 Other assets 40,527 40,744 Total assets $ 1,836,587 $ 1,635,165 Liabilities and stockholders’ equity Other current liabilities $ 32,650 $ 43,808 Accrued interest payable 231 1,618 Deferred revenue 3,677 4,270 Convertible senior notes, due 2028, net 258,095 257,731 Deferred tax liabilities, net 72,831 31,793 Income tax payable, long term 58,345 57,013 Other long term liabilities 69,103 66,091 Stockholders’ equity 1,341,655 1,172,841 Total liabilities and stockholders’ equity $ 1,836,587 $ 1,635,165 INNOVIVA, INC. Cash Flows Summary (in thousands) (unaudited) Three Months Ended March 31, 2026 2025 Net cash provided by operating activities $ 35,282 $ 48,617 Net cash provided by (used in) investing activities 37,008 (34,674 ) Net cash provided by (used in) financing activities (20,146 ) 183 Net change $ 52,144 $ 14,126 Cash and cash equivalents at beginning of period 550,941 304,964 Cash and cash equivalents at end of period $ 603,085 $ 319,090 Contacts Investor Relations (Internal): Eleanor Barisser Director, Investor Relations and Corporate Communications Eleanor.barisser@inva.com Investors and Media: Argot Partners (212) 600-1902 innoviva@argotpartners.com