Aflibercept-abzv

REYKJAVIK, Iceland, March 18, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ US: ALVO, ICELAND: ALVO, STOCKHOLM: ALVO SDB) Financial Highlights A supplemental long‑form earnings release providing additional operational details and business update for Q4 2025 and the full year is available at: https://investors.alvotech.com/earnings-calendar The supplemental document is provided solely for reference and is not part of this SEC Form 6‑K. The Form 6‑K should not be read together with, or construed as referring to, the supplemental long‑form release. Q4 2025 Highlights Total revenues1 were $173 million, up 13% Year-on-Year (YoY) Adjusted EBITDA1 was $69 million with Gross Margin at 66% AVT05 was approved as a biosimilar to Simponi® in the UK and European Economic Area (EEA) AVT03 was approved as a biosimilar to Prolia® and Xgeva® in the EEA The EMA accepted for review a marketing application for AVT23, referencing Xolair® After the end of the quarter, Alvotech entered into supply and commercialization agreements with Sandoz, covering multiple biosimilars candidates in Canada, Australia and New Zealand FY 2025 Highlights Total revenues1 were $593 million, up 21% YoY Adjusted EBITDA1 was $137 million, up 27% YoY, with Gross Margin at 61% The cash balance on December 31, 2025, was $172 million Second biosimilar in the US, Selarsdi™ referencing Stelara® launched by commercial partner Teva Three new biosimilars were approved in multiple markets, including the UK, EEA and Japan Alvotech acquired Xbrane’s R&D organization in Sweden and Ivers-Lee Group in Switzerland The company listed its shares on Nasdaq Stockholm and raised new equity Linda Jonsdottir was appointed Chief Financial Officer, Dr. Balaji V. Prasad was appointed Chief Strategy Officer, while Joseph McClellan transitioned into the role of Chief Operating Officer and Anthony Maffia into the role of Chief Regulatory and Quality Officer ________________________________ 1 Figures are adjusted to exclude items that are not indicative of our ongoing operating performance. Please see the disclaimer on ‘Non IFRS Financial Measures’ at the end of this press release. As a foreign private issuer, Alvotech is not required to, and does not, prepare or file quarterly financial statements under IFRS or with the SEC. The financial information included in this Form 6-K reflects management’s current estimates and is presented for the purpose of providing an interim business update. Comments by Chairman of the Board and Outgoing CEO, Róbert Wessman: “Last year we continued to expand our dedicated end-to-end biosimilars platform, advancing our pipeline with the launches of three newly approved biosimilars, expanding our R&D operation and adding a centralized assembly and packaging unit through acquisitions, while also strengthening our global network through new commercial partnerships. “We now have five approved and on-market biosimilars supported by our global partners which provide Alvotech with commercial reach into 90 countries worldwide. We have an industry leading pipeline of 30 biosimilars in development and continue adding to it at an accelerated pace. “During the year we further strengthened our financial position, raising close to $300 million from capital markets to support continued investment in our development programs and manufacturing platform. We broadened our investor base through the listing of shares on Nasdaq Stockholm, providing better access to Nordic and European investors. “At the same time, we addressed the regulatory observations following the FDA inspection of our Reykjavik manufacturing facility and we implemented a comprehensive improvement program. Based on the progress made so far, we expect to resubmit the affected applications to the FDA during the second quarter of 2026. We have addressed regulatory observations before, and we know how to resolve them. Our focus has been on strengthening the operational platform so that we can continue to scale the business globally. “We have strengthened the leadership team, with Lisa Graver’s appointment as Chief Executive Officer, and all the key management of the company is now located onsite in Iceland. Lisa and I have worked together for over twenty years, and she is ideally positioned to lead the company through this next stage. She knows the company very well, having been a board member since 2022, which gives her a deep understanding of our strategy, our platform and our global partnerships. “As Executive Chairman of the Board I will continue to be actively engaged in the business, and I am looking forward working closely with Lisa and the leadership team as we continue building Alvotech into a leading biosimilars company.” Outlook for 2026 Management reaffirms its outlook for 2026. With continued focus on robust cash flow and margin expansion by delivering solid sales growth and driving operational efficiencies across the company, management anticipates total revenues in the range of $650-700 million in 2026, reflecting continued double-digit sales growth. Adjusted EBITDA is expected to increase to $180-220 million, supported by higher volumes of commercialized products and launches of newly approved products in Europe, the UK and Japan. Alvotech anticipates receiving U.S. approval by late 2026 for four Biologics License Applications from the U.S. Food and Drug Administration, with minimal impact on the topline. The lower end of the revenue range assumes no revenues from new launches into the U.S. market in 2026. Invitation to Q4 2025 and Full Year 2025 management presentation: Join us to listen to the live audio webcast at 8:00 AM EST (12:00 GMT, 13:00 CET) on Thursday, March 19, 2026. The audio webcast will be accessible via the following link: https://edge.media-server.com/mmc/p/u2p8ged8/ To participate via telephone in the Q&A session, please register using this link to obtain your PIN: https://register-conf.media-server.com/register/BI1c565f9bbee94c928c676ea73f178077 Presentation slides for the webcast and other materials are available on the company’s website: https://investors.alvotech.com/earnings-calendar For further information, please contact: Media – alvotech.media@alvotech.com Benedikt Stefansson Sarah MacLeod Investors - alvotech.ir@alvotech.com Dr. Balaji V Prasad (US) Patrik Ling (SE) Benedikt Stefansson (IS) The information was submitted for publication through the agency of the contact persons. Financial calendar: Annual or interim results will be released on the dates specified below, after the close of U.S. markets. An earnings call is held on the following day, after release of the results. Please note that all dates are subject to change. About Alvotech Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube. Forward Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. Non IFRS Financial Measures This Presentation may include projections of certain financial measures not presented in accordance with International Financial Reporting Standards (“IFRS”) including, but not limited to, Adjusted Revenues, EBITDA and certain ratios and other metrics derived therefrom. These non-IFRS financial measures are not measures of financial performance in accordance with IFRS and may exclude items that are significant in understanding and assessing the Company’s financial results. Therefore, these measures should not be considered in isolation or as an alternative to net income, cash flows from operations or other measures of profitability, liquidity or performance under IFRS. You should be aware that the Company’s presentation of these measures may not be comparable to similarly-titled measures used by other companies. The Company believes these non-IFRS measures of financial results provide useful information to management and investors regarding certain financial and business trends relating to the Company’s financial condition and results of operations. The Company believes that the use of these non-IFRS financial measures provide an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other similar companies, many of which present similar non-IFRS financial measures to investors. These non-IFRS financial measures are subject to inherent limitations as they reflect the exercise of judgments by management about which expense and income are excluded or included in determining these non-IFRS financial measures. Due to the high variability and difficulty in making accurate forecasts and projections of some of the information excluded from these projected measures, together with some of the excluded information not being ascertainable or accessible, the Company is unable to quantify certain amounts that would be required to be included in the most directly comparable IFRS financial measures without unreasonable effort. Consequently, no disclosure of estimated comparable IFRS measures is included and no reconciliation of the forward-looking non-IFRS financial measures is included. For the same reasons, the Company is unable to address the probable significance of the unavailable information, which could be material to future results.

山德士（Sandoz）于2023年从诺华拆封出来独立上市，2025年作为该司独立运营业务的第二个完整的财年。当地时间2026年2月25日，山德士发布了年度业绩公告，财务数据在西方仿制药巨头中着实亮眼。公司全年实现净销售额110.86亿美元，以恒定汇率（CC）计算同比增长5%；若剔除业务剥离与收购的影响，则为6%。更为亮眼的是盈利能力的显著提升，核心税息折旧及摊销前利润（EBITDA）同比增长14%，达到24.05亿美元，利润率扩大160个基点至21.7%；核心稀释每股收益（EPS）大幅增长33%，达到3.64美元。这份成绩单清晰地揭示，山德士正成功地从一个传统的仿制药巨头，向一个以生物类似药（Biosimilars）为增长引擎、兼顾创新的“可及性药物”平台转型。 一、 营收增长稳健，盈利与现金流同步优化 2025年，山德士的收入增长主要由8%的销量增长驱动，但部分被3%的价格下降所抵消。第四季度增长加速，净销售额达30.29亿美元，以恒定汇率计算增长6%，显现出良好的季度势头。 公司核心EBITDA利润率从2024年的20.1%提升至21.7%，这主要得益于销售结构的优化——高利润的生物类似药占比提升、运营效率的提升以及严格的成本控制。核心投入资本回报率（ROIC）从12.3%大幅提升至14.5%，反映了资本运用效率的增强。 现金流是公司健康度的另一明证。2025年，公司管理自由现金流（经一次性项目调整）达到15.47亿美元，较2024年的11.12亿美元猛增39%，这主要得益于核心EBITDA的强劲增长。充裕的现金流为公司持续投资研发、进行战略收购和回报股东提供了坚实基础。董事会已提议将每股股息从0.60瑞士法郎提高至0.80瑞士法郎，相当于核心净收入的27%。二、 生物类似药高歌猛进，仿制药稳中求进 山德士的仿制药业务（Generics）和生物类似药（Biosimilars）业务均实现了稳步增长，这种业绩表现在西方仿制药巨头中格外亮眼。然而不论仿制药业务还是biosimilar，山德士业绩增长的主要驱动源都是欧洲市场，北美市场因为激烈的竞争，销售额相比2024年均没有明显改变。 1. 生物类似药业务：无可争议的增长引擎 山德士是全球biosimilar龙头，其全年收入达到32.92亿美元，以恒定汇率计算增长13%，按可比增长率计算更是高达18%。其在总净销售额中的占比从2024年的28%提升至30%。地域方面，欧洲市场增长14%，主要得益于Pyzchiva®（乌司奴单抗）、Binocrit®（促红素α）和Hyrimoz®（阿达木单抗）的优异表现。国际市场（包括亚太、拉美等）增速高达30%，由Omnitrope®（人生长激素）和Hyrimoz驱动。北美市场在可比基础上（剔除Cimerli®退市影响）增长19%，显示出强大的内生增长动力。 业务增长主要来源于一系列成功的产品上市。2025年2月，Pyzchiva在美国上市；6月，Wyost & Jubbonti®（地舒单抗）作为首个FDA批准的可互换地舒单抗生物类似药在美国推出；11月，首个多发性硬化症生物类似药Tyruko®（那他珠单抗）在美国上市；同月，Afflibre®（阿柏西普）在欧洲上市，进军百亿美元抗VEGF市场。这些重磅产品的接连上市，不仅带来了即期收入，更巩固了山德士在肿瘤和免疫学领域的领导地位。2. 仿制药业务：在挑战中保持韧性 仿制药业务全年收入为77.94亿美元，以恒定汇率计算增长2%，占总收入的70%。在激烈的价格竞争和行业结构性压力下，能保持小幅增长实属不易，体现了该业务的韧性和公司的运营能力。地域方面，欧洲市场增长2%，主要得益于2024年和2025年新产品的上市。国际市场在调整剥离中国业务的影响后，增长4%，受益于持续的提价和新品上市。北美市场收入保持稳定，激烈的市场竞争被2024年第四季度紫杉醇在美国的成功上市及加拿大市场的良好表现所抵消。 面临结构性挑战：财报特别指出，青霉素原料药（特别是6-APA）因美国对中国加征关税导致中国供应商大幅降低全球售价，增加了市场供应，这影响了山德士2025年下半年的仿制药净销售额表现，且预计此影响将持续至2026年上半年。这凸显了仿制药业务在复杂全球贸易环境下的脆弱性。三、 从“仿制”到“可及性创新”的全面升级 2025年的业绩不仅是财务数字的体现，更是山德士深度战略变革的初步成果。公司的战略已从过去单一的仿制药生产，升级为以“为患者提供可及性”为核心目标，构建包括复杂仿制药、生物类似药乃至未来创新疗法在内的多元产品组合。1. 研发管线：构建面向未来的“弹药库” 山德士拥有行业领先的研发管线，包括27个生物类似药资产和约400个仿制药项目，剑指4200亿美元的可仿资源（按原研市场）。2025年，管线取得积极进展，关键生物类似药项目的监管流程得以优化。此外，公司还与EirGenix Inc.签署了全球许可协议，商业化帕妥珠单抗（pertuzumab）的生物类似药，进一步强化了其在肿瘤领域的布局。2. 垂直整合与产能投资：夯实生物类似药领导地位的基石 为确保在生物类似药领域的长期竞争力，山德士大力投资建设垂直整合的欧洲研发制造网络。2025年12月，公司战略收购了Just-Evotec Biologics EU SAS（包括法国图卢兹的基地），并获得了其尖端连续制造技术的永久许可。此项收购，加上在斯洛文尼亚卢布尔雅那（生物类似药开发中心）和伦达瓦（新的生物类似药原料药生产中心）的持续投资，旨在加强内部开发与生产能力，降低对外部合同生产组织的依赖，提升供应链的可靠性与成本效益。3. 市场拓展与产品上市：驱动增长的执行引擎 2025年被公司定义为“具有里程碑意义的一年”，实现了生物类似药和仿制药的一系列重磅上市。除了前述生物类似药，仿制药方面也有重磅上市，如在德国推出利伐沙班，在美国推出蔗糖铁注射液，拓宽了在抗凝血和缺铁性贫血治疗领域的可及性。公司全年实现了创纪录数量的产品上市，这些上市产品在2025年贡献了显著的收入，并将在未来几年持续放量。四、 2026年展望与潜在挑战 由于强大biosimilar业务领先优势和欧洲地缘性优势，山德士自独立以来，业绩实现了持续增长，而且从未出现净亏损，这让该司在普遍亏损的西方仿制药巨头中鹤立鸡群。 山德士独立报告的历年财务数据（百万美元） 基于强劲的业务势头，山德士对2026年给出了乐观的指引：预计净销售额将以恒定汇率计算实现中高个位数百分比增长，核心EBITDA利润率预计将进一步扩大约100个基点。公司预计近期上市的生物类似药（如Pyzchiva, Wyost & Jubbonti, Tyruko）将成为增长加速的主要动力。 然而，挑战依然存在。仿制药业务，特别是青霉素类产品，将继续承受国际贸易扭曲带来的价格压力。公司明确表示，不预期2026年会有司美格鲁肽仿制药的重大贡献，且整体定价环境预计将出现低至中个位数百分比的下降。此外，包括美国可能加征新关税在内的不可预见事件，也为前景带来了诸多不确定性。 立即扫码加入药事纵横交流群