Vilanterol Trifenatate

前言在如今高度两极分化的时代，减税、控枪、甚至是否给穷人发放食物券都能成为美国共和党和民主党争论的议题，但是，关于美国处方药定价与其他国家相比不公平这一观点，是一个罕见的能得到两党支持的问题。例如，美国前总统唐纳德-特朗普（Donald Trump）在卸任前签署了一项行政命令，规定医疗保险为某些药物支付的费用，不得高于经济合作与发展组织任何成员国为该药物支付的最低价格。独立参议院议员尼-桑德斯（Bernie Sanders）也在今年早些时候表示，美国的处方药支付价格位列全球第一，某些情况下，药品价格甚至是其他任何国家人民支付的10倍。图片来源：Nicole Bean for BioSpacePolitiFact 则指出，美国大多数药品的价格差异并没有那么明显。在Rand Corporation对2018年的药价进行分析后也发现，美国处方药中占大头的非专利药价格比 32 个参照国平均还低了16%。不过，Rand Corporation这项分析所研究的是药品的清单价格，并不能反映药房的福利折扣和保险公司谈判达成的任何折扣。所以，这可能不是各国人民的实际支付情况。高昂的美国药价其实，在大多数情况下，美国人的药物支付费用要高于其他国家。Rand Corporation也发现，美国同种品牌药品的价格平均高出其他国家的344%。不仅如此，不同药品的平均价格也存在巨大的悬殊。墨西哥作为美国的邻国，药品平均价格降低了70%有余，而与土耳其的对比更为夸张，整整高出了土耳其679%。图片来源：Nicole Bean for BioSpace分析完美国整个宏观视角下的药品价格，我们不妨将单个药物拎出来做一个细分成本分析。在Peterson-KFF Health System Tracker 对 2017 年数据的分析发现，艾伯维公司用于治疗各种关节炎和其他炎症的Adalimumab在在美单价比英国高 423%，比德国高 186%。美国政府一份报告显示，2020年用于治疗慢性阻塞性肺病的 Umeclidinium和Vilanterol在美单价为248美元，澳大利亚为 64 美元，加拿大为 76 美元，法国为 49 美元。这还仅是美国政府使用了美国折扣后的药品价格，与其他国家药品毛价格的对比，实际上的差距可能更让人瞋目结舌。单价差距的悬殊早在成本价中就已经加好了砝码。例如，慢性丙型肝炎药物sofosbuvir和velpatasvir在美国的成本为 14437 美元，澳大利亚为 8668 美元，加拿大为 16204 美元，法国为 9211 美元……显然，美国政府意识到了这一点，在一系列的相关政策轮番失败后，在2022年颁布了《通货膨胀削减法案》，终于使美国政府能够开始就医疗保险所涵盖的药品价格进行谈判。目前各大药企或是”自愿“，或是”被迫“，也都纷纷将医保谈判纳入了他们的行程。另外，今年夏天，众议院民主党人提出了《为美国家庭降低药品成本法案》，该法案将扩大每年可协商价格的药品数量，但《国会山报》指出，该法案在共和党主导的众议院获得通过的可能性很小。尽管如此，民主党在上周提出了更为直接了当的《制止制药公司宰客和为所有人节省药品费用法案》，将矛头直指药品专利。总之，无论这些措施成功的可能性有多大，如何平衡美国药价必将成为大选年的争论焦点。刚柔并济的国内医保反观国内，三年新冠疫情过去了，各行各业复工复产，医药行业自然也不例外，尤其是创新药行业。因此，虽说我国在2023年启动了有史以来领域最广的一次药价谈判，但为了鼓励创新药企业的发展，政府也给出了最大诚意，在医保局发布的《谈判药品续约规则（2023 年版征求意见稿）》中做出了3项重大改动。第一，在建议续约核心梯度降价规则（0-25%的梯度降幅）不变的前提下，对于连续纳入目录”协议期内谈判药品部分“超过4年的药品，可在前述计算值的基础上减半。第二，医保基金支出预算从2025年续约开始不再按照销售金额65%计算，而是以纳入医保支付范围的药品费用计算，医保支付节点金额也相应调增，将之前的2亿元、10亿元、20亿元、40亿元从2025年开始相应调增为3亿元、15亿元、30亿元、60亿元。这样一来，众多创新药企业的单品可能不会触发更高的降幅第三，在2022年通过重新谈判或补充协议方式增加适应症的药品，在今年计算续约降幅时，将扣除之前的降幅……总之，国内的医保谈判正在朝着更加温和的方向前进，为中国创新药行业提供了更为温润的发育土壤。参考文献：1.  人民日报2.biospace3.其他公开资料封面图来源：123rf当ADC老大哥决定卖身：“只”卖出100亿美元，今年好不容易才盈利，就把自己给出手了…… 点击在看 共济新药研发浪潮

Received GSK royalties of $57.0 million and net product revenues of $13.7 million in the third quarter of 2023 Launched first-in-class therapy XACDURO® for treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter Announced positive topline Phase 3 zoliflodacin data for treatment of gonorrhea in November 2023 Repurchased $11.0 million of common stock BURLINGAME, Calif.--(BUSINESS WIRE)-- Innoviva Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a portfolio of royalties and other healthcare assets, today reported financial results for the third quarter ended September 30, 2023, highlighted select corporate achievements and provided an overview of its key business initiatives. Gross royalty revenue from Glaxo Group Limited (“GSK”) for the third quarter 2023 was $57.0 million, which included royalties of $45.6 million from global net sales of RELVAR®/BREO® ELLIPTA® and royalties of $11.4 million from global net sales of ANORO® ELLIPTA® compared to $65.6 million for the third quarter of 2022, which included royalties of $55.7 million from global net sales of RELVAR®/BREO® ELLIPTA® and $9.9 million from global net sales of ANORO® ELLIPTA®, respectively. Net product sales and license revenue for the third quarter of 2023 was $13.7 million, which included $8.0 million from GIAPREZA® net sales, $5.1 million from XERAVA® net sales and $0.6 million from XACDURO® net sales. Net income was $82.0 million, or $1.26 basic per share, for the third quarter of 2023, compared to net income of $265.5 million, or $3.81 basic per share, for the third quarter of 2022; the decrease was primarily driven by non-repeated gain on sales of our subsidiary, Theravance Respiratory Company, and its TRELEGY® ELLIPTA® royalty stream in July 2022. Cash and cash equivalents totaled $180.0 million. Royalty, product sales and milestone receivables totaled $67.8 million as of September 30, 2023. "The third quarter of 2023 was marked by significant revenues stemming from our royalty portfolio and solid performance by our internal product portfolio,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “A few weeks ago, we launched XACDURO® in the United States and are encouraged by the market receptivity. Moreover, we announced positive topline data from the Phase 3 trial of our lead pipeline asset, zoliflodacin, and are excited about its potential to affect the treatment paradigm for gonorrhea patients, especially in the presence of antimicrobial resistance concerns. These milestones reinforce the strength and promise of our infectious disease and critical care business.” Mr. Raifeld concluded, “We continued to exercise cost discipline and saw meaningful operational progress among our investees. In addition, we benefited from significant increases in the equity fair values of our investments. We are confident in the prospects of our business and plan to continue to pursue shareholder-friendly policies, such as share repurchases.” Third Quarter 2023 and Recent Highlights GSK Net Sales Third quarter 2023 net sales of RELVAR®/BREO® ELLIPTA® by GSK were $303.9 million with $109.5 million in net sales from the U.S. market and $194.4 million from non-U.S. markets. Third quarter 2023 net sales of ANORO® ELLIPTA® by GSK were $175.8 million with $89.2 million net sales from the U.S. market and $86.6 million from non-U.S. markets. Corporate Updates During the third quarter of 2023, Innoviva repurchased 856,750 shares of its outstanding common stock for $11.0 million. On July 10, 2023, Innoviva’s wholly owned subsidiary, Innoviva Strategic Opportunities, entered into a credit and security agreement with Armata Pharmaceuticals, Inc. (NYSE: ARMP) (“Armata”) and invested $25.0 million to advance Armata’s pipeline of therapeutic phage candidates and support the buildout of its state-of-the art cGMP manufacturing facility. On August 21, 2023, Innoviva appointed Stephen Basso as Chief Financial Officer. Clinical Updates In September 2023, Innoviva’s wholly owned subsidiary, Innoviva Specialty Therapeutics, launched XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). XACDURO® is the first and only pathogen-targeted antibiotic and a significant advancement in the way healthcare professionals treat Acinetobacter. In November 2023, in collaboration with The Global Antibiotic Research & Development Partnership (GARDP), we announced that zoliflodacin, a first-in-class antibiotic, met its primary endpoint in a global pivotal phase 3 clinical trial for the treatment of uncomplicated gonorrhea, a prevalent disease affecting over 80 million patients a year globally with rapidly rising antimicrobial resistance concerns. Study investigators found that oral zoliflodacin demonstrated statistical non-inferiority of microbiological cure at the urogenital site when compared to treatment with intramuscular injection of ceftriaxone and oral azithromycin, a current global standard of care regimen. In the study, zoliflodacin demonstrated a favorable safety pro was generally well tolerated, with the majority of adverse events being mild-to-moderate. There were no discontinuations reported due to adverse events, serious adverse events, or deaths. About Innoviva Innoviva is a diversified holding company with a portfolio of royalties and other healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/ vilanterol, “FF/VI”) and ANORO® ELLIPTA® (umeclidinium bromide/ vilanterol, “UMEC/VI”). Under the Long-Acting Beta2 Agonist (“LABA”) Collaboration Agreement, 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 hospital 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 (Acinetobacter) 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, 2022 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 Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Revenue: Royalty revenue, net (1) $ 53,558 $ 62,150 $ 172,681 $ 260,429 Net product sales 13,701 5,107 40,942 5,107 License revenue - - 11,000 - Total revenue 67,259 67,257 224,623 265,536 Expenses: Cost of products sold (inclusive of amortization of inventory fair value adjustments, excluding depreciation and amortization of intangible assets) 10,182 3,680 27,910 3,680 Cost of license revenue - - 1,600 - Selling, general and administrative 28,636 27,810 71,913 46,084 Research and development 3,989 11,725 31,566 31,447 Amortization of acquired intangible assets 6,511 1,511 15,274 1,511 Gain on sale of Theravance Respiratory Company, LLC (“TRC”) - (266,696 ) - (266,696 ) Loss on debt extinguishment - - - 20,662 Changes in fair values of equity method investments, net (71,980 ) (10,298 ) (67,886 ) 44,475 Changes in fair values of equity and long-term investments, net 2,640 10,168 4,887 23,406 Interest and dividend income (4,114 ) (2,135 ) (11,032 ) (3,181 ) Interest expense 4,396 5,096 13,205 11,761 Other expense, net 1,047 (28 ) 4,289 750 Total expenses (18,693 ) (219,167 ) 91,726 (86,101 ) Income before income taxes 85,952 286,424 132,897 351,637 Income tax expense 3,906 57,077 14,706 63,061 Net income 82,046 229,347 118,191 288,576 Net income attributable to noncontrolling interest - (36,176 ) - 6,341 Net income attributable to Innoviva stockholders $ 82,046 $ 265,523 $ 118,191 $ 282,235 Basic net income per share attributable to Innoviva stockholders $ 1.26 $ 3.81 $ 1.79 $ 4.05 Diluted net income per share attributable to Innoviva stockholders $ 0.98 $ 2.80 $ 1.45 $ 3.07 Shares used to compute basic net income per share 64,953 69,731 66,016 69,640 Shares used to compute diluted net income per share 86,164 95,830 87,504 95,072 (1) Total net revenue is comprised of the following (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 (unaudited) (unaudited) Royalties $ 57,014 $ 65,606 $ 183,049 $ 270,797 Amortization of capitalized fees (3,456 ) (3,456 ) (10,368 ) (10,368 ) Royalty revenue, net $ 53,558 $ 62,150 $ 172,681 $ 260,429 INNOVIVA, INC. Condensed Consolidated Balance Sheets (in thousands) (unaudited) September 30, December 31, 2023 2022 Assets Cash and cash equivalents $ 179,997 $ 291,049 Royalty and product sale receivables 67,765 64,073 Inventory, net 40,515 55,897 Prepaid expense and other current assets 16,722 32,492 Property and equipment, net 361 170 Equity and long-term investments 529,531 403,013 Capitalized fees 87,239 97,607 Right-of-use assets 2,828 3,265 Goodwill 17,905 26,713 Intangible assets 236,845 252,919 Deferred tax assets 4,952 - Other assets 3,444 4,299 Total assets $ 1,188,104 $ 1,231,497 Liabilities and stockholders’ equity Other current liabilities $ 33,802 $ 32,322 Accrued interest payable 833 4,359 Deferred revenue 1,548 2,094 Convertible subordinated notes, due 2023, net - 96,193 Convertible senior notes, due 2025, net 191,115 190,583 Convertible senior notes, due 2028, net 254,603 253,597 Other long term liabilities 68,690 70,918 Deferred tax liabilities - 5,771 Income tax payable - long term 10,020 9,872 Innoviva stockholders’ equity 627,493 565,788 Total liabilities and stockholders’ equity $ 1,188,104 $ 1,231,497 INNOVIVA, INC. Cash Flows Summary (in thousands) (unaudited) Nine Months Ended September 30, 2023 2022 Net cash provided by operating activities $ 107,808 $ 192,827 Net cash used in investing activities (61,610 ) (47,956 ) Net cash used in financing activities (157,250 ) (45,567 ) Net change $ (111,052 ) $ 99,304 Cash and cash equivalents at beginning of period 291,049 201,525 Cash, cash equivalents and restricted cash at end of period $ 179,997 $ 300,829