Zoliflodacin

Durable royalties portfolio generated $58.4 million in revenue for the fourth quarter and $250.3 million for the full year IST achieved U.S. net product sales of $33.9 million for the fourth quarter and $119.2 million for the full year, representing 47% year-over-year growth IST product portfolio strengthened with U.S. FDA approval of NUZOLVENCE ® , a first-in-class treatment for uncomplicated urogenital gonorrhea $125 million share repurchase program initiated in the fourth quarter 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 fourth quarter and full year ended December 31, 2025, and highlighted select corporate progress and achievements. “2025 marked an excellent year for Innoviva, demonstrating strength across all areas of our business, with 15% revenue growth to over $400 million and net income exceeding $270 million. Our royalty business continued to provide stable and resilient cash flow, while IST generated 47% year-over-year U.S. sales growth to $119 million,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “We expanded our commercial portfolio with the successful mid-2025 launch of ZEVTERA in the U.S., received nominations for two of our products for the prestigious 2025 Prix Galien USA Award, and ended the year on an exciting note with the FDA approval of our fifth product, NUZOLVENCE, a single-dose oral treatment for uncomplicated urogenital gonorrhea that addresses a critical public health challenge in light of the global rise of gonococcal drug resistance. We are excited about our growth prospects and anticipate $150 million or more in IST U.S. net product sales in 2026.” “Our portfolio of strategic assets remains a key platform for long-term growth and differentiation, demonstrated by significant advances and value creation at Armata Pharmaceuticals. Overall, we remain a well-capitalized company with multiple value-accretive capital deployment opportunities in our current business, novel assets, and capital strategies, including a recently announced $125 million share repurchase program. We look forward to multiple inflection points across Innoviva’s portfolio in the year ahead,” concluded Mr. Raifeld. Financial Highlights Total revenue: Total revenue for the fourth quarter 2025 was $114.6 million, representing 25% growth compared to total revenue of $91.8 million for the fourth quarter 2024. Total revenue for the full year 2025 was $411.3 million, reflecting 15% growth compared to total revenue of $358.7 million for the full year 2024. Royalty revenue: Fourth quarter 2025 gross royalty revenue from Glaxo Group Limited (“GSK”) was $58.4 million and full year was $250.3 million, compared to $66.0 million for the fourth quarter 2024 and $255.6 million for the full year 2024. Net product sales: Fourth quarter 2025 net product sales were $59.1 million, more than doubling from $28.9 million in the same quarter of 2024. Full year 2025 net product sales were $172.1 million, an increase of 77% compared to $97.5 million for the full year 2024. For the fourth quarter 2025, U.S. net product sales were $33.9 million and ex-U.S. net product sales were $25.1 million. Fourth quarter 2025 U.S. net product sales primarily consisted of $19.3 million from GIAPREZA ® , $10.7 million from XACDURO ® , and $3.8 million from XERAVA ® . For the full year 2025, U.S. net product sales were $119.2 million and ex-U.S. net product sales were $52.9 million. Full year 2025 U.S. net product sales primarily consisted of $71.8 million from GIAPREZA ® , $33.4 million from XACDURO ® , and $13.3 million from XERAVA ® . Income from operations: Fourth quarter 2025 income from operations was $39.0 million, compared to $43.1 million for the fourth quarter 2024. Full year 2025 income from operations was $163.7 million, compared to $166.9 million for the full year 2024, reflecting continued investments in research and development. Equity and long-term investments: Fourth quarter and full year 2025 net favorable changes in fair values of equity and long-term investments totaled $153.8 million and $161.6 million, respectively, and were primarily attributable to share price appreciation of Armata Pharmaceuticals. Innoviva’s portfolio of strategic assets held through the Company’s various subsidiaries was valued at $614.0 million as of December 31, 2025, and consisted of $397.9 million in Armata Pharmaceuticals investments, $136.4 million in other strategic equity and convertible debt investments, and $79.7 million in investments held by ISP Fund. Net income: Fourth quarter 2025 net income of $164.2 million ($2.19 basic earnings per share) and full year 2025 net income of $271.2 million ($4.02 basic earnings per share) were 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 $550.9 million. Royalty and net product sales receivables totaled $93.3 million as of December 31, 2025. 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 ® for the treatment of uncomplicated urogenital gonorrhea. FDA approval was based on results from the largest Phase 3 clinical trial ever conducted for a new treatment against Neisseria gonorrhoeae infection in regions with a high prevalence of gonorrhea across five countries. Additionally, in December 2025, the positive NUZOLVENCE ® Phase 3 data for the treatment of uncomplicated urogenital gonorrhea were published in The Lancet . The Company plans to commercialize NUZOLVENCE ® in the second half of 2026, either in collaboration with a commercialization partner or independently. In October 2025, IST delivered data from six presentations at IDWeek 2025, including clinical data, pharmacokinetic/pharmacodynamic analyses, and microbiologic surveillance from its growing portfolio of antibiotics and critical care medicines. Both ZEVTERA ® (ceftobiprole medocaril sodium) and XACDURO ® (sulbactam for injection; durlobactam for injection) were nominated for the 2025 Prix Galien USA Award for Best Pharmaceutical Product by the Galien Foundation, one of the most prestigious honors in the biopharmaceutical and medical technology fields, celebrating groundbreaking achievements that drive meaningful progress. Capital Allocation Since the inception of the share repurchase program, the Company has repurchased 797,298 shares for $16.0 million. In October 2025, Innoviva invested $17.5 million in the Series B Preferred Stock of Beacon Biosignals, Inc., an AI-driven neurotechnology company developing treatments for neurological, psychiatric, and sleep disorders. 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 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 Year Ended December 31, December 31, 2025 2024 2025 2024 Revenue: Royalty revenue, net (1) $ 54,896 $ 62,520 $ 236,479 $ 241,733 Net product sales 59,064 28,935 172,130 97,492 License and other revenue 653 351 2,719 19,486 Total revenue 114,613 91,806 411,328 358,711 Cost of products sold (inclusive of amortization of inventory fair value adjustments) 32,309 7,165 77,384 36,598 Amortization of acquired intangible assets 6,637 6,511 26,277 25,902 Gross profit 75,667 78,130 307,667 296,211 Operating expenses: Selling, general and administrative 32,124 31,326 113,318 115,690 Research and development 4,555 3,665 30,604 13,654 Total operating expenses 36,679 34,991 143,922 129,344 Income from operations 38,988 43,139 163,745 166,867 Changes in fair values of equity method investments, net 111,149 (21,256 ) 141,433 (64,253 ) Changes in fair values of equity and long-term investments, net 42,669 1,666 20,160 (59,161 ) Interest and dividend income 6,151 5,768 21,086 19,141 Interest expense (3,309 ) (4,749 ) (16,698 ) (22,209 ) Other expense, net (612 ) 126 (2,864 ) (2,997 ) Income before income taxes 195,036 24,694 326,862 37,388 Income tax expense (30,883 ) (4,362 ) (55,697 ) (13,996 ) Net income $ 164,153 $ 20,332 $ 271,165 $ 23,392 Net income per share: Basic $ 2.19 $ 0.32 $ 4.02 $ 0.37 Diluted $ 1.94 $ 0.26 $ 3.30 $ 0.36 Shares used to compute net income per share: Basic 74,796 62,626 67,395 62,726 Diluted 85,264 84,200 84,760 74,187 (1) Total net revenue is comprised of the following (in thousands): Three Months Ended Year Ended December 31, December 31, 2025 2024 2025 2024 (unaudited) (unaudited) Royalties $ 58,351 $ 65,975 $ 250,302 $ 255,556 Amortization of capitalized fees (3,455 ) (3,455 ) (13,823 ) (13,823 ) Royalty revenue, net $ 54,896 $ 62,520 $ 236,479 $ 241,733 INNOVIVA, INC. Condensed Consolidated Balance Sheets (in thousands) (unaudited) December 31 2025 2024 Assets Cash and cash equivalents $ 550,941 $ 304,964 Royalty and product sale receivables 93,317 86,366 Inventory 39,172 33,725 Prepaid expense and other current assets 28,358 21,719 Current portion of ISP Fund investments 15,727 107,532 Property and equipment, net 1,555 514 Equity method and equity and long-term investments 598,223 393,957 Capitalized fees 56,138 69,961 Right-of-use assets 10,929 2,453 Goodwill 17,905 17,905 Intangible assets 182,156 208,433 Deferred tax assets, net — 12,054 Other assets 40,744 41,477 Total assets $ 1,635,165 $ 1,301,060 Liabilities and stockholders’ equity Other current liabilities $ 43,808 $ 39,507 Accrued interest payable 1,618 3,422 Deferred revenue 4,270 1,126 Convertible senior notes, due 2025, net — 192,028 Convertible senior notes, due 2028, net 257,731 256,316 Deferred tax liabilities, net 31,793 — Income tax payable, long term 57,013 53,227 Other long term liabilities 66,091 64,275 Stockholders’ equity 1,172,841 691,159 Total liabilities and stockholders’ equity $ 1,635,165 $ 1,301,060 INNOVIVA, INC. Cash Flows Summary (in thousands) (unaudited) Year Ended December 31, 2025 2024 Net cash provided by operating activities $ 196,930 $ 188,690 Net cash provided by (used in) investing activities 40,496 (63,786 ) Net cash provided by (used in) financing activities 8,551 (13,453 ) Net change $ 245,977 $ 111,451 Cash and cash equivalents at beginning of period 304,964 193,513 Cash and cash equivalents at end of period $ 550,941 $ 304,964 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

A one-dose oral drug called zoliflodacin has proven highly effective against gonorrhoea in a major international trial. The pill matched the success of current treatments while avoiding injections and complex dosing. As antibiotic resistance spreads, this new option could make treatment simpler and more accessible worldwide. Approval could mark a major step forward in controlling a stubborn global STI.Researchers are testing a new oral medication called zoliflodacin that could offer a simpler way to treat gonorrhea, especially strains that no longer respond well to existing antibiotics. In a late-stage phase 3 clinical trial published in The Lancet, scientists found that a single dose of this pill worked just as well as the current standard treatment used today. Phase 3 trials are the final and largest testing stage before a drug can be approved. They are designed to confirm how well a treatment works and to closely monitor safety in large groups of people. In this case, the results suggest zoliflodacin may be ready to become a real-world option. Why Gonorrhea Is Becoming Harder to Treat Gonorrhea is one of the most widespread sexually transmitted infections in the world, with more than 82 million new cases each year. It is caused by a bacterium that infects the reproductive tract and can also affect the throat and rectum. If left untreated, it can lead to serious health problems, including infertility. One of the biggest challenges in treating gonorrhea is antibiotic resistance. Over time, bacteria can adapt and survive drugs that once killed them. As a result, doctors have fewer effective treatment options. The current recommended therapy relies on two antibiotics: an injection of ceftriaxone followed by an oral dose of azithromycin. This approach works, but it requires access to injections and careful medical supervision. How the New Treatment Performed in Trials The new study included more than 900 participants across five countries (USA, South Africa, Thailand, Belgium, and the Netherlands). Volunteers were randomly assigned to receive either zoliflodacin or the standard two-drug treatment. The results were encouraging. More than 90 percent of genital infections were cured with the single-dose pill. Researchers also found that the drug was generally well tolerated. Side effects were similar to those already seen with existing gonorrhea treatments, and no serious safety concerns were reported during the trial. What FDA Review Could Mean Going Forward Zoliflodacin is now under review by the U.S. Food and Drug Administration (FDA), the agency responsible for evaluating the safety and effectiveness of new medications in the United States. Approval would allow the drug to be prescribed more widely. According to the study authors, access to a one-dose oral treatment could make a major difference worldwide. It could simplify care, support community-led treatment programs, reduce reliance on injections, and help slow the spread of drug-resistant gonorrhea. If approved, the medication could play an important role in protecting reproductive health for millions of people around the globe.