Angiotensin II Acetate

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

精彩内容近日，人福医药公告称，其全资子公司武汉普克申报的3类仿制药萘普生钠软胶囊（0.22g）国内首家获批生产并视同过评，截至目前累计研发投入约170万元。该产品属于非甾体类抗炎药物，米内网数据显示，2023年中国三大终端六大市场（统计范围详见本文末）抗炎抗风湿化药销售额超过220亿元。萘普生钠软胶囊为非甾体类抗炎药物，具有解热、镇痛、抗炎等作用，适用于缓解轻至中度疼痛，如关节痛、神经痛、肌肉痛、偏头痛、头痛、痛经、牙痛等。此前，萘普生钠有片剂、胶囊剂、颗粒剂、注射剂等多种剂型在销，此次人福医药的萘普生钠软胶囊剂国内首家获批，填补了该剂型的空白。值得一提的是，目前国内暂无企业布局该产品，人福医药有望在长时间内保持独家身份。米内网数据显示，2023年中国三大终端六大市场抗炎抗风湿化药销售额超过220亿元，同比增长约7%，2024上半年其销售额超过110亿元。从小类看，非甾体抗炎和抗风湿药占主导地位。近年来中国三大终端六大市场抗炎抗风湿化药销售情况（单位：万元）来源：米内网格局数据库2024上半年抗炎抗风湿化药TOP5品牌中，先声药业的1类新药艾拉莫德片居于榜首，较2023年提升1个位次；上药中西制药的硫酸羟氯喹片紧接其后，强生的布洛芬混悬液排位第三。从销售额增速看，江苏正大清江制药的盐酸氨基葡萄糖片大涨48.13%，先声药业的艾拉莫德片涨幅接近30%。2024上半年中国三大终端六大市场抗炎抗风湿化药TOP5品牌来源：米内网格局数据库今年以来，人福医药有8个品种获批生产并视同过评，包括5个神经系统药物、1个抗肿瘤和免疫调节剂、1个全身用抗感染药物及1个肌肉-骨骼系统药物。其中，萘普生钠软胶囊、盐酸他喷他多片为国内首仿+首家过评，琥珀酸地文拉法辛缓释片、马来酸咪达唑仑片国产第2家获批等。2025年以来人福医药获批上市的品种来源：米内网中国申报进度（MED）数据库此外，今年以来，人福医药还有5个品种以新注册分类申报上市/临床，分别为布瑞哌唑片（暂无首仿）、血管紧张素Ⅱ注射液（市场空白）、磷酸奥司他韦干混悬剂、戊酸雌二醇片及布洛芬软胶囊。资料来源：米内网数据库、公司公告等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至4月25日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦