Ranibizumab biosimilar(Formycon AG)

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Strong first quarter performance, with net sales [1] of USD 2.5 billion, up 6% in constant currencies (up 5% in USD)Biosimilar business growing 21% in constant currencies All regions contributing to growthAcquisition of CIMERLI® (ranibizumab-eqrn) completed in March 2024 Basel, May 7, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced net sales for the first quarter 2024. Net sales were USD 2.5 billion, an increase of 6% in constant currencies compared to the same quarter of the prior year. Biosimilars saw another quarter of double-digit net sales growth, an increase of 21% in constant currencies. Generics sales remained in line with prior year levels. Richard Saynor, Chief Executive Officer of Sandoz, said: “We saw a strong start to the year as we report our 10th consecutive quarter of topline growth. The momentum in our business continues as demonstrated by double-digit growth in biosimilars and a positive contribution by all regions.” Mr. Saynor continued: “Biosimilars are a key element of performance, driven by strong results in our existing portfolio, demand for our recently launched product Hyrimoz® (adalimumab-adaz) in the US and the recent acquisition of CIMERLI® (ranibizumab-eqrn), which closed in early March. Generics remained in line with the strong prior year sales. Looking forward, we are confident in our ability to continue to grow our top line and meet our full-year net sales guidance of mid-single digits in constant currencies.” FIRST QUARTER NET SALES RESULTSNet sales for the first quarter were USD 2.5 billion, up 6% in constant currencies, compared to the first quarter of 2023. Volume contributed 10 percentage points of growth, partially offset by price erosion of 4 percentage points. Biosimilars were a key driver of growth in the quarter, while generics remained in line with the strong prior year sales. Net sales by business Three months ended March 31 Change % USD millions unless indicated otherwise 2024 2023 USD cc* Generics 1869 1868 0 1 Biosimilars 623 516 21 21 Net sales to third parties 2492 2384 5 6 *Constant currencies Generics overviewNet sales for the first quarter were USD 1.9 billion, up 1% in constant currencies, compared to the first quarter of 2023. Solid volume demand was partly offset by the impact from the withdrawal of apixaban in the Netherlands following a court decision in August 2023, an exceptional cough and cold season in the first half of 2023 and the timing of new launches in the US. Biosimilars overviewNet sales for the first quarter were USD 623 million, up 21% in constant currencies, compared to the first quarter of 2023. This strong double-digit biosimilar growth reflects the ongoing launch of Hyrimoz® high-concentration formulation, the acquisition of CIMERLI® as well as continued strong demand for our first-ever biosimilar, Omnitrope®. Net sales by region Three months ended March 31 Change % USD millions unless indicated otherwise 2024 2023 USD cc Europe 1326 1270 4 2 North America 524 496 6 6 International 642 618 4 12 Net sales to third parties 2492 2384 5 6 Europe overviewNet sales for the first quarter were USD 1.3 billion, up 2% in constant currencies, compared to the first quarter of 2023. Generic volume growth remained positive despite a strong prior year comparison from peak sales of apixaban and an exceptional cough and cold season. Biosimilars showed strong sales growth, led by demand for Omnitrope® and contribution from the recent launch of Tyruko® (natalizumab) in several key countries. North America overviewNet sales for the first quarter were USD 524 million, up 6% in constant currencies, compared to the first quarter of 2023. Growth was driven by the ongoing launch of Hyrimoz® in the US, continued demand for Omnitrope®, the acquisition of CIMERLI® which closed in early March, and the transfer of mature brands from our former parent in the fourth quarter of 2023. 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 first quarter were USD 642 million, up 12% in constant currencies, compared to the first quarter of 2023. This was primarily a result of strong volume growth across both generics and biosimilars, the acquisition of Mycamine® in the prior year and favorable price dynamics. GUIDANCE 2024The company reiterates its full-year 2024 guidance, expecting net sales to grow mid-single digit in constant currencies versus prior year and core EBITDA margin around 20%. FIRST QUARTER STRATEGIC MILESTONESOn January 31, we announced the launch of Tyruko® in Germany. Developed by Polpharma Biologics, Tyruko® is the first and only biosimilar to treat relapsing remitting multiple sclerosis. The availability of Tyruko® is a crucial milestone in improving access to effective and safe therapies for those in Europe that need them most. On March 4, we announced the completion of the US biosimilar CIMERLI® acquisition from Coherus BioSciences, Inc, ahead of anticipated timelines. The acquisition builds on the leading Sandoz ophthalmic platform in the US and lays an even stronger foundation for future product launches. On March 5, we announced that Remco Steenbergen, currently a Sandoz Board member, will become a member of the Executive Committee and take on the responsibility of Sandoz CFO as of July 1, 2024. Remco will succeed Colin Bond who will step down from his position as of June 30, 2024, and retire in January 2025 per Swiss employment practice. Colin will be available for transition as a senior advisor through the end of 2024. On March 5, we also announced that the US Food and Drug Administration (FDA) approved Wyost® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines including osteoporosis and cancer-related skeletal events. KEY LINKSWebcast – Live at 9am CETAnalyst Call PresentationAnalyst Consensus NON-IFRS MEASURES IN THIS DOCUMENT AS DEFINED BY SANDOZSandoz uses certain non-IFRS metrics when measuring performance, especially when measuring current period results against prior periods, including core results, constant currencies and free cash flow. Despite the use of these measures by management in setting goals and measuring Sandoz performance, these are non-IFRS measures that have no standardized meaning prescribed by IFRS Accounting Standards. As a result, such measures have limits in their usefulness to investors. Because of their non-standardized definitions, the non-IFRS measures (unlike IFRS measures) may not be comparable to the calculation of similar measures of other companies. These non-IFRS measures are presented solely to permit investors to more fully understand how Sandoz management assesses underlying performance. These non-IFRS measures are not, and should not be viewed as, a substitute for IFRS measures, and should be viewed in conjunction with IFRS financials. As an internal measure of Group performance, these non-IFRS measures have limitations, and Sandoz performance management process is not solely restricted to these metrics. The definitions of the non-IFRS financial metrics as used by Sandoz are as follows: Core resultsSandoz core results – including core EBITDA, core operating income, core net income and core earnings per share – exclude fully: The amortization and impairment charges of intangible assets other than software;Net gains and losses on fund investments and equity securities valued at fair value through profit and loss;Certain acquisition and divestment- related items;Tax liabilities for uncertain tax positions. The following items that exceed a threshold of USD 25 million are also excluded: Integration- and divestment- related income and expenses;Divestment gains and losses;Restructuring charges/releases and related items;Legal related items;Impairments of property, plant and equipment, software and financial assets;And income and expense items that management deems exceptional and that are or are expected to accumulate within the year to be over a USD 25 million threshold. Income tax impacts of such items are also excluded from core measures. Sandoz believes that investor understanding of its performance is enhanced by disclosing core measures of performance because, since core measures exclude items that can vary significantly from year to year, they enable a better comparison of business performance across years. For this same reason, Sandoz uses these core measures in addition to IFRS and other measures as important factors in assessing its performance. The following are examples of how these core measures are utilized: In addition to monthly reports containing financial information prepared under IFRS, senior management receives a monthly analysis incorporating these core measures;Annual budgets are prepared for both IFRS and core measures. As an internal measure of Sandoz performance, the core results measures have limitations, and the Sandoz performance management process is not solely restricted to these metrics. A limitation of the core results measures is that they provide a view of the Sandoz operations without including all events during a period, such as the effects of an acquisition, divestment, or amortization/impairments of purchased intangible assets, impairments to property, plant and equipment and restructurings and related items. Constant currenciesChanges in the relative values of non-US currencies to the US dollar can affect Sandoz financial results and financial position. To provide additional information that may be useful to investors, including changes in sales volume, Sandoz presents information about its net sales and various values relating to operating and net income that are adjusted for such foreign currency effects. Constant currency calculations have the goal of eliminating two exchange rate effects so that an estimate can be made of underlying changes in the consolidated income statement excluding the impact of fluctuations in exchanges rates: The impact of translating the income statements of consolidated entities from their non-USD functional currencies to USD;The impact of exchange rate movements on the major transactions of consolidated entities performed in currencies other than their functional currency. Sandoz calculates constant currency measures by translating the current year’s foreign currency values for sales and other income statement items into USD (excluding the IAS 29 “Financial Reporting in Hyperinflationary Economies” adjustments to the local currency income statements of subsidiaries operating in hyperinflationary economies), using the average exchange rates from the prior year and comparing them to the prior year values in USD. Sandoz uses these constant currency measures in evaluating its performance, since they may assist the Group in evaluating its ongoing performance from year to year. However, in performing its evaluation, Sandoz also considers equivalent measures of performance that are not affected by changes in the relative value of currencies. EBITDASandoz defines earnings before interest, tax, depreciation, and amortization (EBITDA) as operating income, excluding depreciation of property, plant and equipment and right-of-use assets, amortization of intangible assets, impairments of property, plant and equipment, right-of-use assets, and intangible assets. Core EBITDA marginSandoz defines core EBITDA margin as the percentage of core EBITDA over net sales to third parties. It is an indicator to measure the profitability of the Group. CurrenciesReferences to “USD” or “U.S. dollars” are to the lawful currency of the United States of America. RoundingCertain figures contained in the media release, including financial information presented in millions or thousands, certain operating data and percentages describing financial information or market shares, have been subject to rounding. Accordingly, in certain instances, the amounts shown as totals in tables or elsewhere may not conform exactly to the arithmetic total of the figures that precede them. In addition, certain percentages reflect calculations based upon the underlying information prior to rounding and, accordingly, may not conform exactly to the percentages that would be derived if the relevant calculations were based upon the rounded numbers. DISCLAIMERThis 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. ABOUT SANDOZSandoz (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 more than 100 nationalities work together to ensure 800 million patient treatments are provided annually by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1500 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 first biosimilar in 2006. CONTACTS Global Media Relations contacts Investor Relations contacts Global.MediaRelations@sandoz.com Investor.Relations@sandoz.com Joerg E. Allgaeuer+49 171 838 4838 Karen M. King+1 609 722 0982 Chris Lewis+49 174 244 9501 Laurent de Weck+41 61 529 14 85 SUPPORTING FINANCIAL INFORMATION Quarterly sales Q1 2024 USD millions unless indicated otherwise Q1 2024 Change % USD cc Generics 1869 0 1 Biosimilars 623 21 21 Net sales to third parties 2492 5 6 Europe 1326 4 2 North America 524 6 6 International 642 4 12 Net sales to third parties 2492 5 6 FY 2023 USD millions unless indicated otherwise Q1 2023 Change % Q2 2023 Change % Q3 2023 Change % Q4 2023 Change % USD cc USD cc USD cc USD cc Generics 1868 2 6 1850 4 6 1794 5 4 1920 6 6 Biosimilars 516 11 17 533 13 14 543 7 4 623 29 26 Net sales to third parties 2384 4 9 2383 5 8 2337 6 4 2543 11 10 Europe 1270 10 16 1277 14 12 1204 11 3 1272 10 4 North America 496 (5) (3) 508 (4) (2) 510 (4) (3) 615 20 20 International 618 (1) 4 598 (3) 8 623 3 12 656 4 14 Net sales to third parties 2384 4 9 2383 5 8 2337 6 4 2543 11 10 [ 1 ] Net sales in this document refer systematically to net sales to third parties. Attachment SANDOZ Q1 Sales Media Release

本周三，Coherus BioSciences在财报中宣布计划在今年年底前裁员约30%，不久前该公司宣布将专注于肿瘤学，并将眼科生物仿制药Cimerli出售给山德士。被裁的员工中大约有35个职位与出售的Cimerli有关，Coherus预计，重组和裁员能为公司节省超过2500万美元的年化成本。君实的合作伙伴2021年2月，君实生物与Coherus签署了许可与商业化协议。君实生物授予Coherus特瑞普利单抗和两个可选项目（如执行）在美国和加拿大的独占许可，以及两个早期阶段检查点抑制剂抗体药物的优先谈判权，并可获得合计最高达11.1亿美元的首付款、可选项目执行费和里程碑付款。两个可选项目分别是JS006和JS018-1。前者是特异性抗TIGIT单克隆抗体注射液，后者是新一代改良的IL-2细胞因子药物。2022年1月，Coherus启动行使可选项目之一JS006选择权的程序，向君实生物一次性支付了3500万美元执行费。但是今年1月，Coherus终止了JS006的合作，将权益退回君实生物。对于终止合作的原因，Coherus的官方解释是，公司收购了SurfaceOncology后，对投资组合优先级进行排序，将资源配给管线中最有前途或最具竞争力的候选产品。他们认为，终止与君实生物在TIGIT项目上的合作符合利益最大化原则。不过特瑞普利单抗（美国商品名：LOQTORZI）在2023年10月成功在美国获批上市，并且成为美国首款且唯一获批用于鼻咽癌治疗的药物。LOQTORZI在美国售卖价格比国内贵被国内很多媒体争相报道。Coherus公司董事长表示：“LOQTORZI的推出是一个基础性的里程碑，标志着Coherus成为一家商业阶段的免疫肿瘤学公司”。出卖眼科仿制药一边买一边卖，可以看出Coherus要业务重组的决心。2024年1月22日，山德士宣布与Coherus达成合作，前者将以1.7亿美元首付款收购后者生物类似药雷珠单抗Cimerli，包括生物制品许可证申请、产品库存、眼科销售和现场报销人才，以及对专有商业软件的访问。Cimerli是基因泰克眼病药Lucentis（雷珠单抗注射剂）的生物类似药，可以与Lucentis完成互换，即Cimerli可用于已获FDA批准的所有适应症。包括，湿性年龄相关性黄斑变性（wAMD）、糖尿病性黄斑水肿（DME）、视网膜静脉阻塞（RVO） 后黄斑水肿、近视脉络膜新生血管形成（mCNV） 和糖尿病视网膜病变（DR）等多种视网膜疾病。Cimerli在2023年第四季度为Coherus带来了5200万美元的销售额，其2023年全年总额达到1.25亿美元。从财报中公布的肿瘤学管线进展可以看出，Coherus未来的业务中心将无限向肿瘤学倾斜。2024年1月，Coherus与INOVIO达成临床合作，在一项3期临床试验中评估LOQTORZI（toripalimab-tpzi）与INO-3112联合用于局部区域晚期、高风险、HPV16/18阳性的口咽鳞癌（OPCC）患者的潜在治疗方法。Coherus在12月的2023年ESMO IO大会和1月的2024年ASCO胃肠癌研讨会上展示了casdozokitug的新1b/2期临床数据，这是一种一流的IL-27拮抗剂。结果显示，casdozokitug单独和联合PD-（L）1抑制剂联合或不联合贝伐珠单抗分别在HCC和NSCLC中具有令人鼓舞的抗肿瘤活性迹象和可接受的安全性。重要的是，反应与IL-27相关生物标志物相关，数据支持计划中的casdozokitug/toripalimab-tpzi在NSCLC和HCC中的临床试验。Coherus计划在2024年第二季度针对新型ILT4靶向抗体CHS-1000提交研究性新药（IND）申请。小结众多的肿瘤学管线，也让Coherus感觉钱不够用了，将赚钱的仿制药卖出去也是无奈之举。除此之外，公司选择从裁员和缩减研发费用等方面来节约开支。公司预计2024年的SG&A和研发费用从2023年的3.015亿美元降至2.50-2.65亿美元，同比至少下降12%。参考来源：1.https://endpts.com/coherus-lays-off-30-of-staff-following-cimerli-sale-to-sandoz/2.https://investors.coherus.com/news-releases/news-release-details/coherus-biosciences-reports-fourth-quarter-full-year-2023