Dexlansoprazole

DUBLIN, March 6, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) today reported financial results for the fourth-quarter ended December 31, 2023. __________ CONSOLIDATED FINANCIAL RESULTS Total revenues were $498 million in fourth-quarter 2023, a decrease of 10% compared to $556 million in fourth-quarter 2022. This decrease was primarily attributable to decreased revenues from the Generic Pharmaceuticals and Sterile Injectables segments, partially offset by increased revenues from the Branded Pharmaceuticals segment. Reported loss from continuing operations in fourth-quarter 2023 was $2,441 million compared to reported loss from continuing operations of $245 million in fourth-quarter 2022. This change was driven by adjustments to our estimated allowed claims, including with respect to certain litigation matters and debt obligations. The allowed claims will be reduced to reflect actual payments upon Chapter 11 emergence, which is expected to occur in second-quarter 2024. Adjusted income from continuing operations in fourth-quarter 2023 was $151 million compared to $190 million in fourth-quarter 2022. This change was primarily driven by decreased revenues. BRANDED PHARMACEUTICALS SEGMENT Fourth-quarter 2023 Branded Pharmaceuticals segment revenues were $246 million compared to $224 million during fourth-quarter 2022. Specialty Products revenues increased 16% to $188 million in fourth-quarter 2023 compared to $162 million in fourth-quarter 2022. This change was primarily due to an increase in XIAFLEX® revenues, partially offset by a decrease in SUPPRELIN® LA revenues mainly driven by lower volumes. Fourth-quarter 2023 XIAFLEX® revenues were $148 million, a 29% increase compared to fourth-quarter 2022 driven by increased net selling price and increased volumes. The increase in net selling price was primarily attributable to reversing approximately $14 million of reserves recorded during the first three quarters of 2023 following application of the final Inflation Reduction Act vial-wastage rebate determination. STERILE INJECTABLES SEGMENT Fourth-quarter 2023 Sterile Injectables segment revenues were $96 million, a decrease of 11% compared to $108 million during fourth-quarter 2022. This decrease was primarily attributable to competitive pressure on VASOSTRICT® and ADRENALIN®. GENERIC PHARMACEUTICALS SEGMENT Fourth-quarter 2023 Generic Pharmaceuticals segment revenues were $139 million, a decrease of 32% compared to $205 million during fourth-quarter 2022. This decrease was primarily attributable to competitive pressure on varenicline tablets, the generic version of Chantix®, and lubiprostone capsules, the authorized generic of Mallinckrodt's Amitiza®, partially offset by revenue from dexlansoprazole delayed release capsules, the generic version of Dexilant®, which launched during fourth-quarter 2022. INTERNATIONAL PHARMACEUTICALS SEGMENT Fourth-quarter 2023 International Pharmaceuticals segment revenues were $17 million, a decrease of 14% compared to $20 million during fourth-quarter 2022. This decrease was primarily attributable to competitive pressure on several products. 2024 FINANCIAL EXPECTATIONS Endo is providing financial guidance for the full-year ending December 31, 2024, which contemplates key uncertainties, including competitive assumptions related to VASOSTRICT® ready-to-use, ADRENALIN ® and generic Dexilant ® products. All financial expectations provided by Endo are forward-looking, and actual results may differ materially from such expectations, as further discussed below under the heading "Cautionary Note Regarding Forward-Looking Statements." CASH, CASH FLOW AND OTHER UPDATES As of December 31, 2023, the Company had approximately $778 million in unrestricted cash and cash equivalents. Fourth-quarter 2023 net cash provided by operating activities was approximately $115 million compared to approximately $110 million net cash provided by operating activities during fourth-quarter 2022. Amitiza® is a registered trademark of a Mallinckrodt company. Dexilant® is a registered trademark of Takeda Pharmaceutical U.S.A., Inc. Chantix® is a registered trademark of Pfizer Inc. __________ __________ SUPPLEMENTAL FINANCIAL INFORMATION To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP financial measures. For additional information on the Company's use of such non-GAAP financial measures, refer to Endo's Current Report on Form 8-K furnished today to the U.S. Securities and Exchange Commission, which includes an explanation of the Company's reasons for using non-GAAP measures. The tables below provide reconciliations of certain of the Company's non-GAAP financial measures to their most directly comparable GAAP amounts. Refer to the "Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures" section below for additional details regarding the adjustments to the non-GAAP financial measures detailed throughout this Supplemental Financial Information section. Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures Non-GAAP Financial Measures The Company utilizes certain financial measures that are not prescribed by or prepared in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP net income and its components and diluted net income per share amounts. Despite the importance of these measures to management in goal setting and performance measurement, the Company stresses that these are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. Because of the non-standardized definitions, non-GAAP adjusted EBITDA and non-GAAP adjusted net income from continuing operations and its components (unlike GAAP net income from continuing operations and its components) may not be comparable to the calculation of similar measures of other companies. These non-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses performance. Investors are encouraged to review the reconciliations of the non-GAAP financial measures used in this press release to their most directly comparable GAAP financial measures. However, the Company does not provide reconciliations of projected non-GAAP financial measures to GAAP financial measures, nor does it provide comparable projected GAAP financial measures for such projected non-GAAP financial measures. The Company is unable to provide such reconciliations without unreasonable efforts due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations, including adjustments that could be made for asset impairments, contingent consideration adjustments, legal settlements, gain / loss on extinguishment of debt, adjustments to inventory and other charges reflected in the reconciliation of historic numbers, the amounts of which could be significant. See Endo's Current Report on Form 8-K furnished today to the U.S. Securities and Exchange Commission for an explanation of Endo's non-GAAP financial measures. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation, including, but not limited to, statements with respect to financial guidance, expectations or outlook, bankruptcy court hearings or approvals, Chapter 11 emergence, and any other statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "outlook," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: the Company's restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the Company's strategy; risks and uncertainties associated with Chapter 11 proceedings; the negative impacts on the Company's businesses as a result of filing for and operating under Chapter 11 protection; the time, terms and ability to obtain approval and consummate the proposed Plan or Reorganization or a sale under Section 363 of the U.S. Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results while in Chapter 11 proceedings; the Company's ability to discharge claims in Chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in Chapter 11 proceedings; the Company's ability to conduct business as usual; the Company's ability to continue to serve customers, suppliers and other business partners at the high level of service and performance they have come to expect from the Company; the Company's ability to continue to pay employees, suppliers and vendors; the ability to control costs during Chapter 11 proceedings; adverse litigation; the risk that the Company's Chapter 11 Cases may be converted to cases under Chapter 7 of the Bankruptcy Code; the Company's ability to secure operating capital; the Company's ability to take advantage of opportunities to acquire assets with upside potential; the impact of competition and the timing of competitive entrants; the Company's ability to satisfy judgments or settlements or pursue appeals including bonding requirements; the Company's ability to adjust to changing market conditions; the Company's ability to attract and retain key personnel; supply chain interruptions or difficulties; changes in competitive or market conditions; changes in legislation or regulatory developments; the Company's ability to obtain and maintain adequate protection for intellectual property rights; the timing and uncertainty of the results of both the research and development and regulatory processes, including regulatory decisions, product recalls, withdrawals and other unusual items; domestic and foreign health care and cost containment reforms, including government pricing, tax and reimbursement policies; technological advances and patents obtained by competitors; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; the Company's ability to integrate any newly acquired products into its portfolio and achieve any financial or commercial expectations; the impact that known and unknown side effects may have on market perception and consumer preference for the Company's products; the effectiveness of advertising and other promotional campaigns; the timely and successful implementation of any strategic initiatives; unfavorable publicity regarding the misuse of opioids; the uncertainty associated with the identification of and successful consummation and execution of external corporate development initiatives and strategic partnering transactions; the Company's ability to advance its strategic priorities, develop its product pipeline and continue to develop the market for XIAFLEX® and other branded and unbranded products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. In addition, U.S. and international economic conditions, including consumer confidence and debt levels, inflation, taxation, changes in interest and currency exchange rates, international relations, capital and credit availability, the status of financial markets and institutions and the impact of continued economic volatility, can materially affect the Company's results. Therefore, the reader is cautioned not to rely on these forward-looking statements. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as public periodic filings with the U.S. Securities and Exchange Commission (the "SEC") and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the SEC. Copies of the Company's press releases and additional information about the Company are available at or you can contact the Endo Investor Relations Department at [email protected]. SOURCE Endo International plc SOURCE Endo International plc

精彩内容步入2024年，正大天晴药业研发进展不断：拿下艾曲泊帕乙醇胺首仿，达雷妥尤单抗生物类似药报临床......过去的2023年是公司创新产品硕果累累的一年：1款1类新药、3款生物类似药获批，3款1类新药申报NDA，30余款1类新药申报IND等。目前正大天晴药业在国内有90款新药（77款1类新药）处于申报临床及以上阶段，17款处于NDA或III期临床阶段；仿制药方面，2018年至今拿下18个重磅首仿，目前过评品种数已达63个（23个首家），此外22个新分类申报品种在审。77款1类新药霸屏！猛攻1700亿市场近年来，正大天晴药业通过自主研发、并购投资、外部引进等方式，不断拓宽在研创新产品管线，推动公司从“肝病为主”向“两核多强”转变，形成了以肝病用药、抗肿瘤药为主体，消化系统、呼吸系统、骨骼肌肉系统等多领域协同发展的研发格局。目前正大天晴药业有4款1类新药获批上市，包括异甘草酸镁注射液（天晴甘美）、盐酸安罗替尼胶囊（福可维）、派安普利单抗注射液（安尼可）及艾贝格司亭α注射液（亿立舒），其中天晴甘美、福可维2022年在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端的销售额分别超过20亿元、30亿元。米内网数据显示，含引进的产品在内，目前正大天晴药业在国内还有90款新药（不含已有批文产品）处于申请临床及以上阶段，其中有77款为1类新药，创新产品管线处于行业前列。正大天晴药业国内在研新药来源：米内网综合数据库90款新药中，8款已申报上市，包括TQ-B3101胶囊（ALK/MET/ROS1抑制剂）、TQ-B3139胶囊（c-Met/ALK/ROS抑制剂）、TQB2450注射液（PD-L1单抗）、TQ-B3525片（PI3Kα/δ抑制剂，国内暂无同靶点药物获批）、格舒瑞昔片（KRAS G12C抑制剂，国内暂无同靶点药物获批）5款1类新药，以及帕妥珠单抗注射液（国内暂无生物类似药获批）、利拉鲁肽注射液2款生物类似药。此外，9款新药已步入III期临床，包括TQB3616胶囊（CDK4/6抑制剂）、抗菌肽PL-5喷雾剂（抗菌肽，国内暂无同类产品获批）、AL2846胶囊（c-Met抑制剂）、TQB3823片（PARP1/2抑制剂）、lanifibranor片（PPAR激动剂）、TQB3454片（IDH1抑制剂）6款1类新药，以及德谷胰岛素注射液（国内暂无国产企业获批）、司美格鲁肽注射液（国内暂无国产企业获批）2款生物类似药。从治疗领域看，90款新药涵盖抗肿瘤和免疫调节剂（抗肿瘤、自身免疫等）、消化系统及代谢药（糖尿病及NASH）、全身用抗感染药物（丙肝、乙肝等）、呼吸系统等治疗领域，其中抗肿瘤和免疫调节剂占比超过60%，涉及小分子抑制剂、单抗、双抗、ADC等药物形式。米内网数据显示，2022年中国公立医疗机构终端抗肿瘤和免疫调节剂销售额超过1700亿元。拿下18个重磅首仿！22个新品在路上作为传统药企向创新研发转型的代表企业之一，正大天晴药业素有“首仿之王”的称谓。2018年至今，正大天晴药业新获批仿制药数量超过40个，其中有18个为首仿（含剂型首仿），涵盖抗肿瘤和免疫调节剂、消化系统及代谢药、杂类、血液和造血系统药物等治疗领域。2018年至今正大天晴药业获批上市的首仿（含同日获批）来源：米内网中国申报进度（MED）数据库18款首仿涉及了多款全球超10亿美元的重磅品种，如利伐沙班、泊马度胺、艾曲泊帕、西格列汀、托法替布、仑伐替尼、达比加群酯、伏硫西汀等，原研产品2022年全球销售额分别超过70亿美元、30亿美元、20亿美元、20亿美元、10亿美元、10亿美元、10亿美元、10亿美元等。此外，目前正大天晴还有22个仿制药（以药品名称计）以新注册分类申报且在审，获批生产后将视同通过一致性评价。若以通用名药品计，则上述药品2022年在中国公立医疗机构终端的销售规模合计超过100亿元。正大天晴药业新注册分类申报且在审的品种来源：米内网中国申报进度（MED）数据库9个品种在国内暂无首仿（含剂型首仿）获批上市，包括奥贝胆酸片、注射用醋酸地加瑞克、血管紧张素Ⅱ注射液、奈拉滨注射液、酒石酸阿福特罗雾化吸入溶液、右兰索拉唑肠溶胶囊、乌美溴铵维兰特罗粉吸入剂、糠酸氟替卡松维兰特罗粉雾剂(Ⅱ)、糠酸氟替卡松维兰特罗粉雾剂(Ⅰ)。63个过评品种亮眼！9大品种备战集采截至目前，正大天晴药业已有63个品种通过/视同通过一致性评价。其中，23个品种为国内首家过评，艾曲泊帕乙醇胺片、依维莫司片、吸入用氯醋甲胆碱、注射用多黏菌素E甲磺酸钠、氢溴酸伏硫西汀片、甲磺酸仑伐替尼胶囊、泊马度胺胶囊、氟维司群注射液等为国内首仿+首家过评。正大天晴药业已过评品种注：带*为首家/独家过评，加粗代表国采中选来源：米内网一致性评价进度数据库从治疗领域上看，63个过评品种涵盖10个治疗大类，主要集中在抗肿瘤和免疫调节剂（20个）、消化系统及代谢药（13个）、全身用抗感染药物（13个）。米内网数据显示，上述3个治疗大类2022年中国公立医疗机构终端的销售额均超过1500亿元。在已落地执行的八批九轮化药集采中，正大天晴药业分别有3个、1个、3个、5个、7个、6个、1个、3个品种中标，合计29个品种。此外，目前公司已过评但暂未纳入集采的品种有19个。正大天晴药业已过评且暂未纳入国采的品种注：标红代表满足5家及以上的竞争条件来源：米内网综合数据库9个已满足5家及以上的充分竞争条件，包括艾曲泊帕乙醇胺片、泊沙康唑注射液、哌柏西利胶囊、沙库巴曲缬沙坦钠片、索磷布韦片、磷酸西格列汀片、氢溴酸伏硫西汀片、注射用福沙匹坦双葡甲胺、阿瑞匹坦胶囊。资料来源：米内网数据库等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；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3月4日，如有疏漏，欢迎指正!本文为原创稿件，转载请注明来源和作者，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