Mylan NV

PRINCETON, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (NASDAQ: ANIP) today announced that the Company will release its third quarter 2024 financial results on Friday, November 8, 2024, prior to the market open. Nikhil Lalwani, President and Chief Executive Officer, Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, and Chris Mutz, Head of Rare Disease, will host a conference call to discuss the results as follows: DateFriday, November 8, 2024 Time8:00 a.m. ET Toll free (U.S.)800-445-7795 Conference ID4757982 Webcast (live and replay)www.anipharmaceuticals.com, under the “Investors” section A replay of the conference call will be available within two hours of the call’s completion and will remain accessible for two weeks by dialing 800-839-8389 and entering access code 4757982. About ANI Pharmaceuticals, Inc. ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives" by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Established Brands business. For more information, visit www.anipharmaceuticals.com. Investor Relations Contact:Lisa M. Wilson, In-Site Communications, Inc.212-452-2793lwilson@insitecony.com SOURCE: ANI Pharmaceuticals, Inc.

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Strong third-quarter biosimilars growth of 37% in constant currencies from existing portfolio and recent launchesGenerics growth acceleration driven by EuropeThird-quarter net sales¹ of USD 2.6 billion, up 12% in constant currencies (up 11% in USD)Nine-month net sales of USD 7.6 billion, up 9% in constant currencies (up 8% in USD)Net sales growth guidance increased to high-single digit in constant currencies (from mid- to high-single digit) and core EBITDA margin² guidance of around 20% confirmed Basel, October 30, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced net sales for the third quarter and nine months ended September 30, 2024. For the third quarter, net sales were USD 2.6 billion, an increase of 12% in constant currencies compared to the same quarter of the prior year. For the first nine months of 2024, net sales were USD 7.6 billion, an increase of 9% in constant currencies compared to the prior year. Richard Saynor, Chief Executive Officer of Sandoz, said: “We remain focused on execution, meeting key milestones in our biosimilars business and progressing on our journey as a standalone company. In recent months, we received approval for Pyzchiva® and Enzeevu™ in the US, launched Pyzchiva® in Europe and see continued strong uptake of Hyrimoz® in the US. “Net sales growth was achieved across generics and biosimilars, with generics accelerating in the third quarter and strong double-digit biosimilars growth in both the third quarter and first nine months. Additionally, all three regions contributed to this strong performance. We expect momentum in our business to continue, driving margin expansion through favorable product mix and leveraging our cost base. We have further advanced on our path to simplifying our business, including progression on the transformation program we launched earlier this year.” THIRD-QUARTER AND NINE-MONTH SALES Net sales for the third quarter were USD 2.6 billion, up 12% in constant currencies, compared to the third quarter of 2023. Volume contributed 13 percentage points of growth. This was partially offset by price erosion of 1 percentage point. Biosimilars were the key driver of growth in the quarter, while generics experienced solid demand. Growth accelerated in both businesses. Net sales for the first nine months of 2024 were USD 7.6 billion, up 9% in constant currencies compared to prior year. Volume contributed 11 percentage points of growth. This was partially offset by price erosion of 2 percentage points. The growth was primarily driven by biosimilars, with strong demand for both the base business and new in-market organic and acquired products in the US. Net sales by business Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc* USDcc*Generics 1 8541 794 34 5 5585 512 12Biosimilars 741 543 3637 2 0841 592 3132Net sales to third parties 2 5952 337 1112 7 6427 104 89 *constant currencies Generics overviewNet sales for the third quarter were USD 1.9 billion, up 4% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 5.6 billion, up 2% in constant currencies versus prior year. Growth in the Europe region accelerated in the third quarter, mainly driven by recent launches. The momentum continued in the International region, aided by demand for the antifungal agent Mycamine® and favorable pricing dynamics, partly offset by the divestment of the Chinese business. North America declined due to timing of new launches in the US. Biosimilars overviewNet sales for the third quarter were USD 741 million, up 37% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 2.1 billion, up 32% in constant currencies versus prior year. The strong double-digit biosimilars growth reflects the uptake of Hyrimoz® (adalimumab) in the US, the acquisition of Cimerli® (ranibizumab), the continued strong demand for our first-ever biosimilar, Omnitrope® (somatropin), and the launches of Tyruko® (natalizumab) and Pyzchiva® (ustekinumab) in Europe. Net sales by region Q3 2024Q3 2023 Change % 9M 20249M 2023 Change %USD millions unless indicated otherwise USDcc USDccEurope 1 3621 204 1312 3 9963 751 76North America 598 510 1718 1 7421 514 1515International 635 623 28 1 9041 839 49Net sales to third parties 2 5952 337 1112 7 6427 104 89 Europe overviewNet sales for the third quarter were USD 1.4 billion, up 12% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 4.0 billion, up 6% in constant currencies versus prior year. Strong growth in biosimilars continues, led by demand for Omnitrope® and the contribution from the recent launches of Tyruko® and Pyzchiva®. Generics momentum accelerated in the third quarter, driven by recent launches and the lapping of the strong prior-year comparison in the first half. North America overviewNet sales for the third quarter were USD 598 million, up 18% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.7 billion, up 15% in constant currencies versus prior year. Growth was driven by the ongoing uptake of Hyrimoz® in the US, the acquisition of Cimerli®, share gain of Omnitrope® in the US and the launch of Wyost®/Jubbonti® in Canada. This was partly offset by a decline in generics sales due to the timing of new launches in the US. International overviewNet sales for the third quarter were USD 635 million, up 8% in constant currencies, compared to the third quarter of 2023. Net sales for the first nine months were USD 1.9 billion, up 9% in constant currencies versus prior year. This was primarily a result of strong volume growth across both generics and biosimilars, contribution from the acquisition of Mycamine® in the prior year, favorable price dynamics and recent launches, partly offset by the divestment of the Chinese business in the second quarter. GUIDANCE 2024 On the back of strong momentum in its biosimilars business and solid generics demand, the company is increasing its full-year 2024 net sales guidance to high-single digit growth in constant currencies versus prior year (from mid- to high-single digit) and is confirming its core EBITDA margin guidance of around 20%. THIRD-QUARTER STRATEGIC MILESTONES Sandoz continued to execute on its strategy and passed additional milestones in its biosimilars portfolio. On July 1, the company announced the US FDA approval of biosimilar Pyzchiva® for all indications of the reference medicine. The company intends to launch Pyzchiva® in the US among the first wave of ustekinumab biosimilars in February 2025. On July 25, Sandoz announced the launch of biosimilar Pyzchiva® across Europe to treat chronic inflammatory diseases. Pyzchiva® was the first biosimilar to launch in Europe with all reference medicine strengths, including an initiation dose for Crohn’s disease. On August 12, Sandoz received FDA approval for Enzeevu™ to treat neovascular age-related macular degeneration. This approval further enhances the company’s leading US ophthalmology portfolio and increases access for patients. Launch timing will be dependent on several factors, including the progress and outcome of pending or potential litigation or any potential settlements. KEY LINKS Webcast – Live at 9am CET Analyst call presentationAnalyst consensus DISCLAIMER This media release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information of the Half-Year Report 2024. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2023, Sandoz recorded net sales of USD 9.6 billion. CONTACTS Global Media Relations contacts Investor Relations contactsGlobal.MediaRelations@sandoz.comInvestor.Relations@sandoz.comSteffen Kurzawa+41 79 800 8501Laurent de Weck+41 79 795 7364Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 5217 SUPPORTING FINANCIAL INFORMATION Quarterly net sales 2024 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDccGenerics 1 86901 1 835-11 1 85434Biosimilars 6232121 7203537 7413637Net sales to third parties 2 49256 2 55579 2 5951112 Q1 2024Change % Q2 2024Change % Q3 2024Change %USD millions unless indicated otherwise USDcc USDcc USDcc Europe 1 32642 1 30823 1 3621312North America 52466 6202223 5981718International 642412 62759 63528Net sales to third parties 2 49256 2 55579 2 5951112 2023 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Generics 1 86826 1 85046 1 79454 1 92066Biosimilars 5161117 5331314 54374 6232926Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 Q1 2023Change % Q2 2023Change % Q3 2023Change % Q4 2023Change %USD millions unless indicated otherwise USDcc* USDcc* USDcc* USDcc* Europe 1 2701016 1 2771412 1 204113 1 272104North America 496-5-3 508-4-2 510-4-3 6152020International 618-14 598-38 623312 656414Net sales to third parties 2 38449 2 38358 2 33764 2 5431110 ¹ Net sales in this document refer systematically to net sales to third parties. In the first nine months of 2023, third-party sales excluded sales to our former parent. Post spin-off, sales to our former parent are reported as third-party sales.² An explanation of non-IFRS measures can be found in the Supplementary financial information of the Half-Year Report 2024 Attachment 241030_Q3 and 9M Sales 2024_ Media Release.pdf

此次医博会由同写意策划，以“发展新质生产力，共享健康新未来”为主题，用全新的视角瞄准国内外医药及大健康产业发展前沿。诚邀海内外医药及大健康各界嘉宾齐聚中国医药城，共赴时代之约。展位/报告火热征集中！ 近期，罗氏眼科双抗法瑞西单抗（Vabysmo）新适应症在华获批，用于治疗视网膜静脉阻塞继发黄斑水肿（MEfRVO）。 眼科药王阿柏西普（Eylea）再受打击。 自2015年销售额反超雷珠单抗（Lucentis）以来，阿柏西普一直统治着整个眼科抗VEGF药物市场，且常年霸榜全球畅销药物TOP10。 但随着专利到期，在即将来临的大量生物类似药以及创新药的围剿下，阿柏西普岌岌可危。 1 钻石赛道开启 视力障碍是一种改变生活的疾病，影响着全球约22亿人。 据沙利文报告，2022年全球眼科药物市场规模已经达到372亿美元，预计2030年将达到734亿美元。2022年中国的规模达到43亿美元，预计2030年将达到169亿美元。 图一：眼科药物市场规模 来源：参考来源1 眼科药物市场增长迅猛，是非肿瘤领域的钻石赛道。 而这一赛道内最亮眼的明星药物类别，自然属于诞生了眼科药王阿柏西普的抗VEGF药物（anti-VEGF，抗血管内皮生长因子）。 VEGF是一种促进血管内皮细胞增生的分子，VEGF家族包括VEGF-A、VEGF-B、VEGF-C、VEGF-D、VEGF-E和胎盘生长因子（PIGF），具有促进血管通透性增加、细胞外基质变性、血管内皮细胞迁移、增殖和血管形成等作用。 研究发现VEGF的高表达与年龄相关性黄斑变性（AMD）、糖尿病视网膜疾病变（DR）等视网膜疾病密切有关，因此，VEGF成为了治疗眼科疾病的潜力靶点。 历经多年开发，眼科抗VEGF药物目前已成为视网膜疾病的首要疗法，包括湿性年龄相关性黄斑变性（nAMD）、糖尿病性视网膜病变(DR)、糖尿病性黄斑水肿(DME)和视网膜静脉阻塞（RVO）以及早产儿视网膜病变（ROP）。 其中，年龄相关性黄斑变性与糖尿病视网膜病变均位居引发视力障碍或失明的前五大原因。 年龄相关性黄斑变性（AMD）是一种广泛分布的眼科疾病，主要影响老年人的视力，全球估计有1400万人受到影响。它是60≥岁个体中心视力丧失的主要原因之一。 其中，湿性AMD也称为渗出性AMD或新生血管性AMD（nAMD），影响全球超过1500万人，约占70岁及以上人口的5%。 而糖尿病视网膜病变（DR）是糖尿病的一种普遍的微血管并发症，影响大约30-40%的糖尿病患者，其中DME是DR的最普遍并发症之一。 并且，近年来随着老年化加剧与糖尿病患病率的逐年上升，nAMD与DR、DME患病人数将持续上升。根据弗若斯特沙利文数据，仅中国2022年便分别有400万例nAMD、730万例DME患者，预计到2026年，患者人群数量将扩大至440万例nAMD和790万例DM，市场潜力巨大。 随着商业化开发的深入，三种药物接力拉开了钻石赛道的帷幕。 眼科抗VEGF药物的历史由哌加他尼（Macugen）在2004年首度开启，但在临床试验中，哌加他尼的临床数据虽优于安慰剂，大多数患者视力仍然呈下降趋势，现在临床已很少应用此药。 图片2：眼科抗VEGF药物时间线 参考来源：公开资料整理 哌加他尼是先行者，但是眼科抗VEGF药物的第一次辉煌却由罗氏2006年上市的雷珠单抗所铸造。 相较于哌加他尼的不温不火，雷珠单抗因疗效显著，在上市后很快名声大噪，首年便实现了7.1亿美元的销售额。 上市首年《科学》杂志还将其评为年度十大科技成果之一，称其为“人类历史上第一次让AMD患者视力得到提高的疗法”。 在2011年前，雷珠单抗可以说是独霸眼科抗VEGF药物市场，其巅峰销售额超过43亿美元。 一直到再生元的当家花旦阿柏西普上市，眼科抗VEGF药物先锋雷珠单抗备受打击，进入了屈辱时代。 阿柏西普的崛起可谓是抗VEGF眼科药物市场上的一场“突袭”。凭借着其最长可以三个月给药一次的优势，阿柏西普犹如一匹黑马，迅速在湿性老龄相关性黄斑变性（nAMD）治疗领域中站稳脚跟。它的推出不仅改变了治疗方式，还给竞争对手雷珠单抗带来了一场“市场地震”。 图片3：阿柏西普与雷珠单抗销售额对比 来源：参考来源2 在阿柏西普上市年后的第一年，它便差点突破10亿美元销售额大关，给当时市场占主导地位的雷珠单抗造成了强烈冲击。到2015年，阿柏西普不但成功反超了雷珠单抗，还登上了全球抗VEGF药物销售冠军的宝座，并自此一路高歌猛进，成为这个市场上无可争议的霸主，常年霸榜全球畅销药物TOP10。 继眼科药王诞生，眼科药物这一钻石赛道终于真正的被阿柏西普完全开启。 2 前后围剿 专利悬崖是重磅药物们避不开的梦魇。 前任全球药王修美乐在巅峰时期（如2022年）的销售额达到了212.37亿美元，然而，到了2023年，其销售额骤降至144.04亿美元，同比下滑了32.2%。进入2024年，修美乐的颓势依旧未改，第一季度销售额仅为22.7亿美元，同比下降了35.89%，且全年销售额极大概率难以破百亿美元。 罗氏的三驾马车贝伐珠单抗(Avastin)、利妥昔单抗(Rituxan)和曲妥珠单抗(Herceptin)，23年销售额合计不足45亿瑞士法郎，较巅峰时期缩量近80%。 虽然从现有竞争格局来看，阿柏西普仍然具有极大的销售优势，但时间却不站在它这边。 在生物类似药大举进攻之前，全新作用机制的双抗药物早已经发起奇袭。 法瑞西单抗（Vabysmo）是一款双特异性抗体药物，开发用于治疗眼科疾病，特别是与视网膜血管异常相关的疾病。它由罗氏（Roche）旗下的基因泰克（Genentech）开发，主要针对两种靶点：血管内皮生长因子A（VEGF-A）和血管生成素-2（Ang-2）。 法瑞西单抗的双重靶点机制使其不仅可以抑制VEGF-A的作用，还能够抑制Ang-2，后者也是血管生成和血管渗漏的关键调节因子。通过这种双重抑制，法瑞西单抗在减少病理性血管生成、改善血液循环和减缓炎症反应方面显示出了较强的潜力。 法瑞西单抗已经在多个临床试验中取得了良好效果，并于2022年被美国食品和药物管理局（FDA）批准用于治疗nAMD和DME。 与阿柏西普相比，法瑞西单抗将治疗周期延长到了每4个月一次，显著的减小了注射次数。由于优异的药效，法瑞西单抗的销售额一经上市便开始大幅放量（23年已达23.57亿瑞士法郎），并对阿柏西普的销售进行了冲击（阿柏西普2023年的全球销售额为92.15亿美元，同比下滑4%）。 除了强力新竞品的冲击，生物类似药们更是已经蓄势待发。 从全球市场来看，早在2021年10月，Mylan就向FDA递交了M710的上市申请，2021年12月获得了FDA的受理。随后，Formycon和Celltrion等公司接连向FDA发起了阿柏西普生物仿制药的申请。 截至目前，已有五款阿柏西普的生物类似药获得FDA批准，最新批准的为安进在2024年8月获批上市的Pavblu。 虽然再生元想法设法的通过专利诉讼进行阻止，如其在2024年1月对安进提起了侵权诉讼，指控Pavblu侵犯了阿柏西普32项专利，请求法院下令禁止安进上市销售Pavblu。但在2024年9月24日，美国西弗吉尼亚州地方法院驳回了“再生元阻止阿柏西普生物类似药Pavblu上市销售”的诉讼请求。裁决结果公布后，再生元股价应声下跌。 从国内市场来看，2023年12月,齐鲁制药阿柏西普生物类似药获批上市，成为国产首款，将和12月在中国同时获批的法瑞西单抗共同携手打破国内市场此前雷珠单抗、阿柏西普、康柏西普的三足鼎立之势。此外，2024年7月16日,CDE网站显示,博安生物的阿柏西普眼内注射溶液申报上市。该品种是第2款申报上市的国产阿柏西普生物类似药。 生物类似药的大幅入侵已成定局。 除开已上市的入局者们，从研发端口来看，全球范围内至少有105个抗VEGF眼科药物项目在研（截至2023年10月）。其中，仅与最炙手可热的法瑞西单抗拥有共同靶点VEGF/ANG-2的双抗药物就已有至少8款在研。 图片4：眼科双抗竞争格局 来源：参考来源3 国内市场的研发更是如火如荼，目前处于三期临床阶段靶向 VEGF 眼科类似药就有5款，其中阿柏西普、雷珠单抗分别有3款、2款。 图片5：国内眼科双抗竞争格局 来源：参考来源3 创新药方面，目前国内至少有18款在研眼科抗VEGF创新药。全球市场与国内市场的众多竞争者们都已迫不及待入场分食眼科药王阿柏西普的市场。 而在即将到来的创新药与生物类似药的全面围剿下，不知阿柏西普是否在那些前任药王的历史里早已经看到了自己惨痛的未来。 3 继承者们 阿柏西普在其原研厂家再生元心里有着极为特殊的情感。 作为再生元开发的第一个大药，是它将上市后便陷在财务困境中二十年的再生元拉出泥潭，也是它见证成再生元从一个初创企业成为了营收超百亿美元、市值超千亿美元的制药巨头（Eylea推出后，股价5年间翻了10倍）。 图片6：再生元营收 来源：参考来源4 尽管不舍，尽管提起了大量专利诉讼，尽管开发了高剂量HD，但也仅仅只能延缓阿柏西普的衰败之路，事物发展的客观大势无法阻挡. 但幸运的是，继承者们已至。 就如同打造了前任药王修美乐的艾伯维，修美乐重挫后，其还有瑞莎珠单抗（SKYRIZI）和乌帕替尼（Rinvoq）来接棒。2023年，Skyrizi的销售额为77亿美元，同比增长50%，Rinvoq销售额为39亿美元，同比增长57%。两者销售额共计超过100亿美元，到2027年将超过修美乐达到270亿美元的峰值收入。 就如同打造了三架马车的罗氏，老三架马车失速后，新三架马车帕妥珠单抗（Perjeta）、恩美曲妥珠单抗（Kadcyla）、阿替利珠单抗（Tecentriq）也早已扬帆起航，在2021年反超了销售额下滑的老三架马车。 再生元也有阿柏西普的继承者，即度普利尤单抗（Dupixent）。作为全球首个获批上市的IL-4Rα靶向单抗，度普利尤单抗市场表现非常亮眼，2023年销售已突破百亿美元(115.89亿美元)，跻身2023全球畅销药TOP6，且在24年上半年销售额已经超越阿达木单抗，荣升全球自免药王。 对于再生元来说，度普利尤单抗在阿柏西普失势之后还会陪着他走很远的路，也能够在很长的时间里提供再生元所需的资金与前进动力，再生元可以放手去打造更多的重磅药物。 图片7：再生元临床项目 来源：参考来源4 截止2024年8月报告，目前再生元拥有包括肿瘤、自免、眼科等重磅领域在内至少35个临床在研药物，其中10个已经进入了临床三期，增长动力十足，相信后续其会持续给到我们惊喜。 最后，对于一家药企而言，纪念优秀前任最有力的方式，也许就是开发出一款又一款畅销的重磅药物。 参考文献： 1、前浪后浪“争斗”不休，VEGF眼药市场谁主沉浮？，药智头条 2、《中国药品制剂行业发展态势分析与投资战略评估报告（2022-2029年）》，观研天下 3、申万宏源、西南证券研究 4、各公司官网 5、Ophthalmic Use of Targeted Biologics in the Management of Intraocular Diseases: Current and Emerging Therapies. https://doi.org/10.3390/antib13040086 同写意媒体矩阵，欢迎关注↓↓↓