Durlobactam/Sulbactam sodium

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 first quarter ended March 31, 2025, and highlighted select corporate progress and achievements. “We are pleased with our strong first quarter financial results, highlighted by robust cash flows from our GSK royalties portfolio and continued excellent growth from the IST-marketed products,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “Our therapeutics business remains a key driver, with an NDA filing for zoliflodacin on track and the U.S. commercial launch of ZEVTERA® (ceftobiprole) anticipated by mid-2025, underscoring our commitment to delivering innovative treatments to patients and our ability to leverage the operating platform.” “Additionally, we remain dedicated to creating value for our shareholders by strategically enhancing our healthcare assets. We are cognizant of the increased market volatility and believe that the strength of our balance sheet, combined with a disciplined approach to capital allocation, positions us well to advance our diversified portfolio and capitalize on new opportunities, thereby supporting sustained growth across market environments,” concluded Mr. Raifeld. Financial Highlights Royalty revenue: First quarter 2025 gross royalty revenue from Glaxo Group Limited (“GSK”) was $61.3 million, compared to $61.9 million for the first quarter of 2024. Net product sales: First quarter 2025 net product sales totaled $30.3 million, consisting of $26.4 million in U.S. net product sales and $3.9 million in ex-U.S. net product sales, compared to $19.1 million in net product sales for the first quarter of 2024. U.S. net product sales included $17.4 million from GIAPREZA ® , $5.8 million from XACDURO ® , and $3.2 million from XERAVA ® , representing a 52% increase compared to total U.S. net product sales of $17.4 million in the first quarter of 2024. Income from operations: First quarter 2025 income from operations was $41.4 million, an increase of 61% from $25.8 million in the first quarter of 2024. Equity and long-term investments: First quarter 2025 unfavorable changes in fair values of equity and long-term investments totaled $78.8 million, compared to favorable changes of $22.0 million in the first quarter of 2024, primarily due to the share price depreciation of Armata Pharmaceuticals and certain equity investments managed by ISP Fund LP. Net income: First quarter 2025 net loss was $46.6 million, or ($0.74) basic per share, compared to net income of $36.5 million, or $0.58 basic per share, for the first quarter of 2024. Cash and cash equivalents: Totaled $319.1 million. Royalty and net product sales receivables totaled $77.9 million as of March 31, 2025. Key Business and R&D Highlights Zoliflodacin: a potential first-in-class, single dose, oral antibiotic is currently being developed together with The Global Antibiotic Research & Development Partnership ("GARDP") for the treatment of patients with uncomplicated gonorrhea. Zoliflodacin NDA on track for filing with the U.S. FDA in the first half of 2025. Zoliflodacin NDA on track for filing with the U.S. FDA in the first half of 2025. ZEVTERA ® (ceftobiprole): an advanced-generation cephalosporin antibiotic that is approved in the U.S. for three specific treatment indications. ZEVTERA ® is the only FDA-approved methicillin-resistant Staphylococcus aureus (MRSA) cephalosporin antibiotic for treating adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB) and endocarditis. ZEVTERA ® is indicated for the treatment of adult patients with SAB, including right-sided infective endocarditis, adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). Following the exclusive distribution and license agreement with Basilea Pharmaceutica Ltd. in December 2024, Innoviva anticipates launching ZEVTERA ® in the U.S. in mid-2025. Following the exclusive distribution and license agreement with Basilea Pharmaceutica Ltd. in December 2024, Innoviva anticipates launching ZEVTERA ® in the U.S. in mid-2025. XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use: a targeted antibacterial treatment for patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. In April, the Company presented in vivo and in vitro data on the activity of durlobactam against Enterobacterales at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global). In April, the Company presented in vivo and in vitro data on the activity of durlobactam against Enterobacterales at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global). Innoviva’s portfolio of strategic assets held through the Company’s various subsidiaries was valued at $457.6 million as of March 31, 2025. In the first quarter of 2025, we invested a total of $34.7 million in various strategic healthcare assets, including $15.0 million in a convertible note of Gate Neurosciences and $10.0 million in a term loan to Armata Pharmaceuticals. 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 commercial and marketed products include infectious disease and critical care assets: GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock; XERAVA® (eravacycline), approved for the treatment of complicated intra-abdominal infections in adults; and XACDURO® (sulbactam for injection; durlobactam for injection), approved for the treatment of hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter in adults. In addition, ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, will be exclusively commercialized by us in the U.S. under a distribution and license agreement with Basilea Pharmaceutica Ltd., (“Basilea”), entered into in December 2024. We continue to advance our pipeline with zoliflodacin, a potentially first in class, single-dose oral treatment for uncomplicated gonorrhea. 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® and ZEVTERA® 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, 2024 and subsequently 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. 2025 2024 $ 57,807 $ 58,415 30,279 19,084 546 — 88,632 77,499 8,842 10,971 6,475 6,440 73,315 60,088 27,491 30,405 4,396 3,878 31,887 34,283 41,428 25,805 (13,549 ) 35,342 (65,299 ) (13,335 ) 4,538 4,399 (4,711 ) (5,851 ) (996 ) (1,236 ) (38,589 ) 45,124 (7,995 ) (8,592 ) $ (46,584 ) $ 36,532 $ (0.74 ) $ 0.58 $ (0.74 ) $ 0.46 62,709 63,185 62,709 84,531 2025 2024 $ 61,263 $ 61,871 (3,456 ) (3,456 ) $ 57,807 $ 58,415 2025 2024 $ 319,090 $ 304,964 77,936 86,366 41,479 33,725 15,727 21,719 127,790 107,532 483 514 329,844 393,957 66,505 69,961 2,110 2,453 17,905 17,905 201,958 208,433 12,294 12,054 41,269 41,477 $ 1,254,390 $ 1,301,060 $ 40,695 $ 39,507 833 3,422 1,002 1,126 192,215 192,028 256,670 256,316 62,009 64,275 54,061 53,227 646,905 691,159 $ 1,254,390 $ 1,301,060 2025 2024 $ 48,617 $ 37,047 (34,674 ) (43,038 ) 183 (9,165 ) $ 14,126 $ (15,156 ) 304,964 193,513 $ 319,090 $ 178,357