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 third quarter ended September 30, 2024, and highlighted select corporate achievements. “For the third quarter of 2024, we continue to deliver strong revenue growth, with solid performance from our core GSK royalty assets, and accelerating sales from our IST commercial products, GIAPREZA ® , XACDURO ® and XERAVA ® . Since the formation of IST, now in its second year of operation, we have shown consistent sales expansion in our commercial products, primarily driven by increasing product demand, validating our investment in hospital-based therapeutics,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “Of special note, XACDURO ® was nominated for the Best Biotechnology Product by The Galien Foundation USA in recognition of its pioneering science and positive impact on patients. We are proud of this recognition which highlights the commitment and innovation we are bringing to this space, where there is significant unmet medical need and an immense demand for new drugs. We also continue to further advance our pipeline and are on track to submit a New Drug Application (“NDA”) for zoliflodacin, potentially first in class, single dose oral drug for the treatment of uncomplicated gonorrhea, to the U.S. FDA in early 2025.” Mr. Raifeld continued, “Over the past quarter, we also saw meaningful operational progress across our strategic healthcare assets. We remain focused on prudent capital allocation in our quest to maximize shareholder value and see multiple opportunities for continued value creation.” Financial Highlights Royalty revenue: Third quarter 2024 gross royalty revenue from Glaxo Group Limited (“GSK”) was $60.5 million, compared to $57.0 million for the third quarter 2023. Net Product Sales: Third quarter 2024 net product sales were $27.8 million, which included U.S. net product sales of $19.7 million and ex-U.S. product sales of $8.1 million. U.S. net product sales consisted of $13.1 million from GIAPREZA ® , $2.3 million from XERAVA ® , and $4.3 million from XACDURO ® , a 68% increase compared to $11.8 million for the third quarter 2023. License Revenue: Third quarter 2024 license revenue of $4.6 million included product development cost-sharing reimbursements from our partner. Equity and long-term investments: Third quarter 2024 unfavorable net change in fair value of equity and long-term investments of $35.2 million was primarily due to lower share price of Armata Pharmaceuticals (“Armata”). Net income : Net income of $1.2 million, or $0.02 basic per share, for the third quarter of 2024, compared to a net income of $82.0 million, or $1.26 basic per share, for the third quarter of 2023. Cash and cash equivalents : Totaled $260.6 million. Royalty and product sales receivables totaled $91.1 million as of September 30, 2024. Key Business and R&D Highlights 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. XACDURO ® was recently nominated for the 2024 Prix Galien USA Award for Best Biotechnology Product, which recognizes excellence in scientific innovation that improves the state of human health. Zoliflodacin : a potential first-in-class, single dose, oral antibiotic is currently being developed in partnership with The Global Antibiotic Research & Development Partnership ("GARDP") for the treatment of patients with uncomplicated gonorrhea. In September 2024, we presented additional findings on our investigational agent zoliflodacin at the 2024 Sexually Transmitted Infections Prevention Conference in Atlanta. The first oral presentation demonstrated that zoliflodacin had potent in vitro activity against 200 clinical isolates, consistent with previous U.S. surveillance data. The second presentation demonstrated that microbiological cure rates for specific subgroups were comparable to the primary endpoint analysis. Safety in these subgroups was also comparable. In October 2024, we had five presentations at IDWeek 2024, which took place in Los Angeles. One oral presentation on zoliflodacin included a review of the unique public-private partnership that led the clinical development of zoliflodacin. The second presentation highlighted the activity of sulbactam-durlobactam and standard-of-care antibiotics against Acinetobacter baumannii-calcoaceticus complex for hospitalized patients in the U.S. Three posters were presented including two on zoliflodacin: In vitro activity against baseline isolates in U.S. participants from the phase 3 trial and a pharmacometrics analysis supporting dose selection. Surveillance data of eravacycline against clinical pathogens, collected worldwide from multiple infections sites during 2018-2022 was also presented. We continue to advance zoliflodacin following its successful Phase 3 clinical trial results and expect 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. INNOVIVA, INC. Condensed Consolidated Statements of Income and Comprehensive Income (in thousands, except per share data) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Revenue: Royalty revenue, net (1) $ 57,056 $ 53,558 $ 179,213 $ 172,681 Net product sales 27,822 13,701 68,557 40,942 License revenue 4,630 - 19,135 11,000 Total revenue 89,508 67,259 266,905 224,623 Expenses: Cost of products sold (inclusive of amortization of inventory fair value adjustments) 9,990 10,182 29,433 27,910 Cost of license revenue - - - 1,600 Selling, general and administrative 26,219 28,636 84,364 71,913 Research and development 3,551 3,989 9,989 31,566 Amortization of acquired intangible assets 6,511 6,511 19,391 15,274 Changes in fair values of equity method investments, net 18,231 (71,980 ) 42,997 (67,886 ) Changes in fair values of equity and long-term investments, net 16,936 2,640 60,827 4,887 Interest and dividend income (5,500 ) (4,114 ) (13,373 ) (11,032 ) Interest expense 5,807 4,396 17,460 13,205 Other expense, net 914 1,047 3,123 4,289 Total expenses, net 82,659 (18,693 ) 254,211 91,726 Income before income taxes 6,849 85,952 12,694 132,897 Income tax expense, net 5,636 3,906 9,634 14,706 Net income and comprehensive income $ 1,213 $ 82,046 $ 3,060 $ 118,191 Net income per share Basic $ 0.02 $ 1.26 $ 0.05 $ 1.79 Diluted $ 0.02 $ 0.98 $ 0.05 $ 1.45 Shares used to compute net income per share Basic 62,569 64,953 62,759 66,016 Diluted 62,951 86,164 63,020 87,504 (1) Total net revenue is comprised of the following (in thousands): Three Months Ended Nine Months Ended September  30, September  30, 2024 2023 2024 2023 (unaudited) (unaudited) Royalties $ 60,512 $ 57,014 $ 189,581 $ 183,049 Amortization of capitalized fees (3,456 ) (3,456 ) (10,368 ) (10,368 ) Royalty revenue, net $ 57,056 $ 53,558 $ 179,213 $ 172,681 INNOVIVA, INC. Condensed Consolidated Balance Sheets (in thousands) (unaudited) September 30, December 31, 2024 2023 Assets Cash and cash equivalents $ 260,630 $ 193,513 Royalty and product sale receivables 91,058 84,075 Inventory 34,236 40,737 Prepaid expense and other current assets 14,697 25,894 Property and equipment, net 544 483 Equity and long-term investments 507,718 560,978 Capitalized fees paid, net 73,416 83,784 Right-of-use assets 2,789 2,536 Goodwill 17,905 17,905 Intangible assets 210,944 230,335 Deferred tax asset, net 14,875 - Other assets 2,800 3,267 Total assets $ 1,231,612 $ 1,243,507 Liabilities and stockholders’ equity Other current liabilities $ 30,357 $ 33,435 Accrued interest payable 833 3,422 Deferred revenue 717 1,277 Convertible senior notes, due 2025, net 191,843 191,295 Convertible senior notes, due 2028, net 255,972 254,939 Other long-term liabilities 71,449 71,870 Deferred tax liabilities, net - 563 Income tax payable, long-term 11,899 11,751 Innoviva stockholders’ equity 668,542 674,955 Total liabilities and stockholders’ equity $ 1,231,612 $ 1,243,507 INNOVIVA, INC. Cash Flows Summary (in thousands) (unaudited) Nine Months Ended September 30, 2024 2023 Net cash provided by operating activities $ 129,451 $ 107,808 Net cash used in investing activities (48,308 ) (61,610 ) Net cash used in financing activities (14,026 ) (157,250 ) Net change 67,117 (111,052 ) Cash and cash equivalents at beginning of period 193,513 291,049 Cash and cash equivalents at end of period $ 260,630 $ 179,997

关注并星标CPHI制药在线 近日，赛诺菲公布了本年度Q3的全球营收业绩，总营收已经达到了134.38亿欧元，同比增长15.7%，而作为赛诺菲旗下毋庸置疑的当家产品，Dupixent（度普利尤单抗）Q3的销售额增长了23.8%，达到34.76亿欧元，加上前两个季度，其2024目前的总销售额已经达到96.14亿欧元，几乎突破了百亿欧元大关。其适应症已经涵盖了特应性皮炎、哮喘、慢性鼻窦炎伴鼻息肉病、嗜酸性食管炎和结节性痒疹等，而在今年九月底，Dupixent正式被FDA批准用于治疗慢性阻塞性肺疾病（COPD），成为首个获批治疗该适应症的生物制剂，这一革命性适应症也必将继续助推Dupixent的”重磅炸弹”之路。 赛诺菲2024Q3营收（赛诺菲官网） 众所周知，COPD是一种常见的、可以预防和治疗的异质性疾病，一般是由长期接触有毒颗粒或气体引起的气道和肺泡异常所致，并受到宿主因素影响，以气流受限及持续的呼吸道症状为主要特征。根据世界卫生组织统计，COPD已经成为人类的第三大死因，约有11%的人死于COPD。预计未来40年COPD的患病率将不断增加，到2060年每年可能会有超过540万人死于COPD及其相关疾病。 在今年之前，COPD领域已经有数十年未有新疗法获批，虽然最高标准的三联疗法（LABA/LAMA/ICS，长效β2受体激动剂/长效抗胆碱药/糖皮质激素）能够显著改善肺功能并减少急性加重的频率，但仍有大约一半患者在接受三联治疗后出现COPD急性加重。换句话说，COPD治疗药物目前仍然存在巨大未被满足的临床需求，这也就代表着，COPD药物背后的市场，仍是一座尚待发掘的巨大金矿。随着今年6月小分子药物Ensifentrine以及大分子生物制剂Dupixent的相继获批，沉寂数十年的COPD领域也终于迎来了两款重磅药物，为全球患者带来了全新希望。 01 Dupixent领衔生物制剂 COPD发病机制探索复杂且至今仍未阐明，慢性炎症反应被认为是最重要的发病机理之一，目前研究较多的是由Th1通路介导的中性粒细胞增多和Th2通路介导的啫酸性粒细胞增多。中性粒细胞炎症是COPD的主要特征，早期针对COPD的生物制剂探索集中在这一方向，但均以失败告终。故同为呼吸系统疾病，当单抗在哮喘领域屡屡取得成功之时，却在COPD领域迟迟难以打开僵局。 有20%至40%的COPD患者表现出嗜酸性粒细胞表型，且嗜酸性粒细胞与其COPD急性加重密切相关。目前已有研究结果显示，靶向Th2通路相关细胞因子的生物制剂在COPD领域逐步展现出积极疗效。 以靶向于白细胞介素-4受体a亚基(IL-4Ra)、IL-5、IL-33和胸腺基质淋巴细胞生成素(TSLP)为代表的单抗生物制剂渐成四强争霸之势。但在2018年，同为两款生物制剂的葛兰素史克的Nucala和阿斯利康的Fasenra双双失利，更是给COPD生物药蒙上了巨大阴影。终于，作为一款IL-4Ra药物的Dupixent迈过了终点线，IL-4也成为了第一款成药的COPD生物制剂靶点。 一项评估度Dupixent在伴发气道疾病 2 型炎症的中重度 COPD 患者中的疗效和安全性的 3 期临床试验 BOREAS 的结果显示：52 周内中重度 COPD 的急性发作减少了 30% (p=0.0005)。此外，BOREAS 研究治疗达到了所有次要终点。此外，评估Dupixent辅助治疗症状无法控制的 COPD 成人患者的疗效的 3 期临床试验 NOTUS 也取得积极结果：普利尤单抗在 52 周内将疾病恶化降低 34%。第 12 周时，度普利尤单抗治疗组患者肺功能较基线提高 139 mL，安慰剂组为 57 mL（p=0.0001），益处持续到第 52 周，度普利尤单抗组为 115 mL，安慰剂组为 54 mL（p=0.0182）。 长久以来，由于COPD的异质性，针对COPD的多数生物制剂都已沉戟，Dupixent的获批极大的提振了领域内的研发信心。?基于此，GlobalData预测药物将主导 COPD 生物制剂市场，即到 2033 年 Dupixent COPD的适应症将为其带来 65.7 亿美元的收入，与此同时， Dupixent 在全球范围内的获批以及商业化也将直接助推COPD药物治疗市场的快速扩张，GlobalData也预测在全球主要COPD市场的七个国家中（美国、法国、德国、意大利、西班牙、英国和日本），COPD市场销售额将从 2023 年的 115 亿美元增长到 2033 年的 308 亿美元。 IL-4 靶点COPD适应症研发概况（参考自西南证券） 快速增长的市场份额自然也给了其他生物制剂进场的机会，除了IL-4之外，IL-5、IL-33等介导2型炎症的单抗是COPD治疗的热门机制，约占全球临床后期在研项目的一半以上，mepolizumab、benralizumab、astegolimab、itepekimab、tozorakimab等5款新药也均处于Ⅲ期临床阶段。 和IL-4一样的是，IL-33也被广泛认为是一种重要的免疫调节因子，主要通过促进 Th2 型免疫反应来发挥其生物学功能且与嗜酸粒细胞计数密切相关IL-33 通过与 ST2 受体结合，激活 Th2 细胞并诱导 IL-4、IL-5 和 IL-13 等Th2 型细胞因子的产生，从而促进Th2免疫和系统性炎症。IL-33与与多种炎症性疾病相关，如类风湿关节炎、特应性过敏、哮喘、心血管疾病等。但也有研究指出，IL-33 通过 ST2 受体与某些免疫细胞相互作用可以增强 IFN-y的产生，从而增强Th1型免疫反应。目前 赛诺菲/再生元开发的的 itepekimab、罗氏开发的astegolimab以及阿斯利康开发的tozorakimab也都进入了Ⅲ期临床，并有望成为继IL-4之后第二个成药的COPD治疗靶点。 TSLP靶点目前也有重大突破，安进/阿斯利康合作开发的靶向于TSLP单抗Tezspire（tezepelumab）最早于2021年获得FDA批准用于严重哮喘治疗。Tezspire也是唯一一个没有表型或生物标志物限制的哮喘生物药。今年4月，Tezspire治疗COPD的IIa期COURSE概念验证试验结果公布。与安慰剂相比，Tezspire可将中度至重度AECOPD平均年恶化率降低17%。 02 小分子治疗迎来巨大突破 在生物制剂迎来重大突破之时，小分子药物也在今年6月份迎来了柳暗花明，作为今年初曾被行业媒体Evaluate列为2024有望获批的10款重磅疗法之一，20多年来具有新作用机制、用于COPD维持治疗的首 个吸入式疗法的Ensifentrine获得了FDA的正式批准用于治疗COPD。 Ensifentrine是Verona公司开发的一种小分子选择性磷酸二酯酶（PDE3/4）双抑制剂。PDE3/4在支气管平滑肌上广泛表达，Ensifentrine抑制PDE3/4后，提升支气管内cAMP，进而发挥支气管舒张和抗炎的双重作用。在Ensifentrine获批之前，COPD领域尚无PDE3抑制剂获批，而PDE4抑制剂也仅罗氟司特一款。临床数据显示，罗氟司特+噻托溴铵/沙美特罗对COPD患者肺功能的改善效果优于单药噻托溴铵/沙美特罗。尽管罗氟司特可以作为ICS+LAMA/LABA之外的补充，但其易导致恶心、呕吐等胃肠道不良反应，严重程度足以降低患者的依从性。多项研究表明，相比于单独抑制PDE3或PDE4，同时抑制PDE3和PDE4产生的抗炎和松弛平滑肌作用更强。 FDA此次批准基于ENHANCE-1和ENHANCE-2两项Ⅲ期临床研究数据。ENHANCE-1和ENHANCE-2都是随机、双盲、安慰剂对照的Ⅲ期研究，分别入组760和790名COPD成年患者。相较于安慰剂，Ensifentrine可以显著改善0-12小时内1秒钟平均用力呼吸曲线下面积。 由于目前Ensifentrine的临床试验以及上市申请品种均采用雾化给药方式，需搭配雾化装置，便捷性受限，因此公司正在开发便携型DPI/MDI。且可通过该类制剂延长专利保护期由于Ensifentrine属于COPD领域全新机制，且是小分子，因此理论上可以与其他小分子吸入制剂联用，可产生协同效应，此前Ensifentrine +Tiotro pium 4W临床2期成功。目前公司正在尝试Ensifentrine+ glycopyrrolate 的组合疗法，该研究有望于2024H2启动2期。 凭借着优异的临床数据以及相较于大分子药物的更佳的依从性，对于Ensifentrine SeekingAlpha给出了年销售额21-36亿美元的销售峰值。值得一提的是，2021年6月，Verona公司授予优锐医药在大中华区临床开发和商业化ensifentrine的独家权利。2023年2月，优锐医药启动了Ensifentrine治疗COPD的中国Ⅲ期临床试验，该药或将很快惠及国内COPD患者。 END 来源：CPHI制药在线 声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。 投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~