Sevelamer Carbonate

特约作者 | 张自然博士 责任编辑 | 郑瑶 在第十批国采62个品种中，一半多（33个）有原研药，涉及20家外企，与第四批的32个原研药（涉及13家外企）相当，少于第五批的38个（13家外企）、第三批的36个（12家外企），多于第二批的20个（12家外企）、第一批的18个原研药（9家外企）。 可见，国采涉及的外企数量越来越多，是因大品种主要由研发投入超大的辉瑞、阿斯利康、默沙东、诺华和GSK等大型跨国药企研发和销售，本土仿制药企也首先对市场规模大的大品种进行一致性评价，因此大部分大品种首先被纳入了前几批国采，国采已经进行了九批，到目前，符合条件的大品种已所剩无几，只剩下小品种角逐了。当然，竞争不充分（独家）的、没有参比制剂无法做一致性评价的，以及存在专利纠纷的等不符合国采条件的还有很多大品种，另当别论。 注：本文中的品种销售额是指2023年样本医院的销售额，原研药市场份额是指2023年在全国公立医疗机构的市场份额。 01 原研数 在第十批国采33个原研药涉及的20家外企中，涉及原研药品数量最多的是默沙东，共涉及5个原研药，即西格列汀口服常释剂型、舒更葡糖钠注射液、西格列汀二甲双胍、泊沙康唑肠溶片、泊沙康唑注射液。 其次是辉瑞和拜耳，都涉及4个原研药，如辉瑞的卡前列素氨丁三醇注射剂、哌柏西利胶囊、氨苄西林舒巴坦注射剂、枸橼酸托法替布缓释片，拜耳的瑞戈非尼片、尼莫地平注射剂、环丙沙星注射剂和阿司匹林口服常释剂型。 上述3家外企在前九批国采中选的品种数也都较多，都中选了2个品种，如默沙东的孟鲁司特钠片（4+7扩围）、米氮平片（第八批），辉瑞的利奈唑胺片（第三批）、注射用替加环素（第七批），拜耳在第二批国采中选的阿卡波糖片、盐酸莫西沙星片等。     百特和日本中外制药各涉及2个原研药。  赛诺菲、安斯泰来等14家外企，在第十批国采中只涉及1个原研药。其中，赛诺菲是前九批国采中选品种数最多（4个）的外企，即于4+7扩围中选的硫酸氢氯吡格雷片和厄贝沙坦氢氯噻嗪片、第四批中选的氨磺必利片、第五批中选的注射用奥沙利铂。 02 原研份额vs销售额 在第十批国采62个品种涉及的33个原研药中，市场份额超过10%的有24个。 涉及通用名销售额超过20亿元的只有2个，即复方a-酮酸口服常释剂型（22亿元）、阿司匹林口服常释剂型（21亿元），对应的原研药企勃林格殷格翰、拜耳分别占了64%、79%，占比不低。 销售额＞10亿元的有4个，即西格列汀口服常释剂型（17亿元）、硝酸异山梨酯注射剂（14亿元）、利格列汀口服常释剂型（12.5亿元）、羟氯喹口服常释剂型（12亿元）、复方聚乙二醇电解质（11亿元），分别由默沙东占98%、英联医药占34%、勃林格殷格翰占96%、赛诺菲占18%和法国益普生占17%。     另4个由原研独霸市场的品种销售额也不大，即瑞戈非尼片（9亿元，拜耳占100%）、西格列汀二甲双胍（8.5亿元，默沙东占100%）、马昔腾坦片（2亿元，爱可泰隆占100%）、氢溴酸伏硫西汀片（1.5亿元，丹麦灵北占99%）。 03 原研份额vs竞争企业数 在第十批国采62个品种涉及的33个原研药中，市场份额超过10%的有24个，默沙东就有5个，其中3个品种涉及符合条件的企业数量最多，即西格列汀口服常释剂型（33家）、舒更葡糖钠注射液（20家）、西格列汀二甲双胍（15家），其中西格列汀、西格列汀二甲双胍都由默沙东独霸市场，舒更葡糖钠注射液也由默沙东占了近半（47%）的市场，原研药企默沙东将面临严峻挑战，当然，从往批国采看，外企参与度并不高，但亲手打造的市场拱手让人也心有不甘。 上述3个品种的销售额分别为17亿元、10亿元和8.5亿元，如仍最多允许10家中选的话，将分别有23家、10家和5家不中选而出局，竞争激烈程度可见一斑，尤其对将有20家出局的西格列汀口服常释剂型而言。 其他几个独占市场的原研药瑞戈非尼片（原研：拜耳）、马昔腾坦片（原研：爱可泰隆）、氢溴酸伏硫西汀片（原研：灵北）、利格列汀（原研：勃林格殷格翰）、阿普米司特片(原研：安进)分别有9家、7家、13家、9家、14家符合条件，竞争企业数并不是最多，涉及的市场规模都不太大。    市场份额＞60%的还有6个原研药，即司维拉姆口服常释剂型(健赞占79%)、阿司匹林口服常释剂型(拜耳占79%)、哌柏西利胶囊(辉瑞占69%)、尼莫地平注射剂(拜耳占67%)、复方a-酮酸口服常释剂型(勃林格殷格翰占64%)、泊沙康唑肠溶片(默沙东占64%)，符合条件的企业数分别是9家、14家、13家、9家、8家和8家。除阿司匹林和复方a-酮酸都超过20亿元外，其他的销售额都不大。 附：第十批报量品种清单（供参考，最终以官方消息为准） END 内容沟通：郑瑶（13810174402） 左下角「关注账号」，右下角「在看」，防止失联

€451M Revolving Credit Facility refinanced with a maturity extended to February 2029 Issuance of a €200M Perpetual Deeply Subordinated Hybrid Bond subscribed by Sanofi €54M product capacity reservation for five products and further amendments to the global Manufacturing and Supply Agreement (MSA) agreed with Sanofi “The completion of the financing is an instrumental step in the execution of EUROAPI’s strategic roadmap” said Ludwig de Mot, Chief Executive Officer. “Combined with further developments in our commercial relationship with Sanofi, it opens a new chapter for our company and all its stakeholders.” 10 October 2024 - EUROAPI announces today that it has completed and secured the financing of its FOCUS-27 strategic plan and agreed with Sanofi to further amend the Manufacturing and Supply Agreement signed in 2021. €451M Revolving Credit Facility refinanced with a maturity extended to February 2029 EUROAPI and its banking syndicate1 have agreed on a new secured €451 million Revolving Credit Facility (RCF), refinancing the existing revolving facility with a maturity in February 2029. Loans borrowed under the RCF will bear interest at an EURIBOR-indexed floating rate, plus an applicable margin2, as a function of EUROAPI’s Net Leverage Ratio, defined as Total Net Debt to Consolidated Core EBITDA3. The RCF will be subject to a covenant stipulating that the Net Leverage Ratio may not exceed 4.00x starting 30 June 2027 and a €50 million liquidity covenant applicable from signing until maturity. €200M Perpetual Deeply Subordinated Hybrid Bond subscribed by Sanofi Sanofi confirmed its support in the execution of the FOCUS-27 plan through an investment of €200 million in a Perpetual Deeply Subordinated Hybrid Bond. This non-dilutive instrument, which will be classified as “Equity” in EUROAPI’s consolidated financial statements, provides EUROAPI with additional financial flexibility to deliver its FOCUS-27 plan. On any interest payment date, EUROAPI may decide to defer and capitalize the interest payment, subject to certain conditions, including the absence of dividend payment or share repurchases. The hybrid bond will carry a 8.113% coupon until the first reset date, scheduled for February 2029. The closing of the revised RCF and the Perpetual Deeply Subordinated Hybrid Bond is expected before the end of October 2024 and will end the company’s collaboration with the mandataire ad hoc appointed in June 2024. €54M minimum available capacity reservation for five products agreed with Sanofi To support the implementation of FOCUS-27, Sanofi has agreed to reserve a minimum available capacity for five selected products manufactured by EUROAPI. Sanofi will pay €54 million, of which €18 million in H2 2024, and €36 million in 2025. These capacity reservations will secure revenue and increase the five products' overall performance4. In addition to the capacity reservation, Sanofi and EUROAPI have agreed on further amendments to the Global Manufacturing and Supply Agreement (MSA) signed in 2021, including secured volumes for Sevelamer, which will provide further visibility to Haverhill’s activity in the context of its divestment. These amendments, including the capacity reservation fees, are Regulated Agreements pursuant to the French Commercial Code. Details are available on EUROAPI’s website. EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities. Taking action for health by enabling access to essential therapies inspires our 3,650 people every day. With strong research and development capabilities and six manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries. EUROAPI is listed on Euronext Paris; ISIN: FR0014008VX5; ticker: EAPI). Find out more at www.euroapi.com and follow us on LinkedIn. 1 BNP Paribas, Bank of America, JP Morgan, Crédit Agricole CIB, Société Générale, Deutsche Bank and Natixis 2 The margin will vary from 1.35% to 2.10% 3 Without taking into account the effects of IFRS 16 4 The €54 million capacity reservation is a financial consideration received (paid in H2 2024 and 2025) and will be recognized as revenue once the products are delivered as defined in the contract with Sanofi, mostly after 2027 The content above comes from the network. if any infringement, please contact us to modify.