Adalimumab biosimilar (Sandoz)

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.

见贤而思齐焉，见不贤而内自省也！ 理解美国仿制药企业的战略布局，必须首先正视一个根本性的市场悖论：这个占据全美九成处方量的行业，其销售收入却仅占药品总支出的12%，2024年为美国医疗系统节省了4670亿美元，而自身却深陷利润微薄、竞争惨烈的生存困境。兰德公司（RAND公司）的跨国价格研究揭示了一个令行业从业者既自豪又无奈的现实：美国无品牌仿制药的价格仅为其他发达国家的67%，是名副其实的全球价格洼地。正是这种极端的定价环境，构成了所有市场参与者战略抉择的共同起点，也决定了这个行业必须不断寻找结构性突围的可能路径。 图1 美国制造商处方药总价格占部分其他国家价格的百分比（所有药品，2022年） 来源：作者对IQVIA“MIDAS”数据库2022年销售与销量数据的分析（数据提取日期：2023年5月19日） 注释：所有国家指全部33个经合组织对比国家的总和。其他国家价格设定为100。生物制剂已从无品牌仿制药中剔除。各国销售的仅部分剂型参与了双边比较。品牌原研药和无品牌仿制药的分类基于IQVIA对各国药品的划分标准。 对于身处其中的企业而言，生存法则已然清晰：在普通仿制药领域，成本控制与规模效应是底线，但仅靠这一点已不足以支撑可持续的增长。于是，战略的分化成为必然。以色列巨头Teva的选择颇具代表性。作为全球处方量最大的仿制药企业，Teva明确提出“向生物制药公司转型”的战略方向，其核心逻辑并非放弃仿制药主业，而是在这个拥有深厚积淀的领域内向上攀登。该公司在美国本土运营着九个生产基地，是本土制造布局最深的企业之一，但更值得关注的是其产品结构的演变——从利拉鲁肽注射剂（诺和诺德Saxenda的首个仿制药）到Simlandi（修美乐生物类似药），再到计划到2027年推出25至27种生物类似药，Teva正在用“复杂仿制药+生物类似药”重新定义自己的护城河。这种战略的实质，是在价格被极致压缩的市场环境中，通过提高技术和监管门槛，主动筛选那些竞争相对缓和、定价能力更强的赛道。用Teva高管的话说，“复杂仿制药是我们的基因，我们能够更高效地支持患者”。 与Teva遥相呼应的，是山德士的独立之路。自2023年从诺华拆分后，这家全球仿制药巨头展现出惊人的反弹力，2025年前九个月净销售额增长5%，核心驱动力同样来自生物类似药业务——Humira生物类似药Hyrimoz、Stelara生物类似药Pyzchiva的强劲需求，以及近期获批的Prolia和Xgeva生物类似药，共同支撑起这家传统仿制药企业的价值重估。山德士CEO那句广为流传的调侃——“我们在美国卖一盒抗生素的价格，比一包M&M巧克力还便宜”——精准捕捉了这个行业的成本困境，也解释了为什么山德士和Teva都在不约而同地向生物类似药倾斜。 然而，生物类似药真的是仿制药企业的应许之地吗？三星Bioepis的季度报告提供了一组值得深思的数据：截至2025年第一季度，美国FDA累计批准73款生物类似药，但仅有48款实现商业化，商业化比例仅为66%。更耐人寻味的是修美乐案例——尽管已有10款生物类似药上市，且定价较原研药低80%以上，艾伯维却仍然占据阿达木单抗市场77%的份额。这个数字背后，是原研药企用二十年时间构筑的专利丛林、医生处方惯性、患者品牌忠诚度以及复杂的渠道返利机制共同编织的市场壁垒。而在肿瘤领域，局面却截然不同：贝伐珠单抗、曲妥珠单抗的生物类似药在没有明显价格优势的情况下，竟占据了超75%的市场份额。这一对比揭示了生物类似药市场的一个深层真相——治疗领域的差异决定了替代的难易程度，免疫疾病患者和医生对安全性的高度敏感，与肿瘤治疗中对疗效等价性的理性接受，形成了完全不同的市场渗透逻辑。 这种差异性也在塑造着不同企业的布局路径。安进的选择或许代表了一种更为激进的姿态。面对自身重磅产品Otezla和Enbrel的专利悬崖，安进将生物类似药定位为填补收入缺口的核心支柱，目标是到2030年实现40亿美元的生物类似药销售收入。Wezlana（Stelara生物类似药）和Pavblu（Eylea生物类似药）的上市只是开端，2025年还将推出Soliris生物类似药Bkemv。与Teva和山德士不同，安进的身份是原研药企出身，其布局生物类似药带有明显的防御与进攻双重属性——一方面对冲自有产品专利到期的收入损失，另一方面凭借大分子药物生产的深厚积累，在别人构筑壁垒的领域反向突围。 印度企业的存在，则为美国市场注入了另一股力量。Dr. Reddy‘s的财报显示，截至2025年9月30日，该公司有73件ANDA在FDA排队待批，另有2件新药申请。这种庞大的申报管线背后，是印度企业特有的成本控制能力和原料药-制剂一体化优势。但与Teva、山德士们不同的是，印度企业在美国市场的竞争更多集中在传统仿制药领域，复杂制剂和生物类似药的布局仍处于追赶阶段。这种分工某种程度上延续了全球仿制药产业的价值链分布——一端是掌握技术和渠道的跨国巨头，另一端是依托制造成本的规模生产者。 然而，无论选择哪条路径，所有企业都无法回避一个正在被重新定义的变量：供应链。过去五年，地缘政治的剧烈动荡让“成本最优”的全球化分工模式遭遇前所未有的挑战。特朗普政府的关税威胁、《生物安全法案》的发酵，以及新冠疫情暴露的药品短缺风险，共同推动着一场供应链逻辑的深刻转变。罗氏宣布未来五年在美国投资500亿美元，诺华计划投资230亿美元，礼来投入270亿美元新建四个生产基地，强生则承诺超过550亿美元的制造、研发和技术投资。这些数字乍看惊人，但仔细审视便会发现，这些巨额投资几乎全部流向创新药、基因疗法、减肥药等high-tech领域，与低利润的仿制药并无直接关联。 仿制药供应链的重构，呈现出完全不同的图景。Sandoz和Teva的高管几乎异口同声地指出：无论是高关税还是政策号召，都难以让仿制药制造真正回流美国。原因无他，成本结构完全无法匹配。美国劳动力成本是印度的8倍、中国的5倍以上，环保、安全、合规的投入更是远超海外，而一盒仿制药的终端售价可能只有一两美元。即使不考虑建厂所需的3至5亿美元和3至5年时间，仅从运营成本测算，将API生产迁回美国就可能推高成本50%以上。STAT的一篇评论文章尖锐指出，通过关税强制推动本土化只会助长低效率，最终伤害的是患者的药费负担。 这个看似无解的困局，恰恰构成了理解美国仿制药企业布局的另一条线索。当制造业无法回流，企业能做的是在现有全球分工的基础上增强供应链韧性。Teva的策略是将其供应链主要布局在加拿大、欧洲和以色列，尽可能减少对中国和印度的依赖。同时，在美国本土保留关键的制剂产能和复杂制造能力，以应对潜在的断供风险。这种“全球化采购+区域化储备+本土化核心能力”的混合模式，正在成为头部企业的标准配置。 更深层的变化发生在市场结构层面。仿制药价格之所以低到“比M&M巧克力还便宜”，并非单纯的市场竞争使然，而是由美国独特的药品支付体系塑造的。药品福利管理者主导的议价机制、药房根据通用名自主选择最低价产品的制度、Medicaid和Medicare的报销规则，共同构筑了一个“价格即唯一王道”的交易型市场。在这个体系里，品牌、学术推广、医生教育统统失效，唯一有效的竞争武器就是价格。这也解释了为什么专利丛林、反向支付和解、授权仿制药等原研药企的防御手段，能够如此有效地延缓竞争——因为它们瞄准的不是价格，而是“让竞争本身无法发生”。 站在2026年的时间节点回望，美国仿制药企业的战略布局正在呈现出清晰的层次感。头部企业向上突围，用复杂仿制药和生物类似药构建技术和监管壁垒；印度和中国企业守住成本底线，用规模和效率争夺存量市场；原研药企则从另一侧切入，用自身的大分子制造能力反向收割专利过期红利。而在这些战略选择的底层，是供应链逻辑从“极致效率”向“韧性优先”的缓慢转身，是地缘政治对全球分工的持续重塑，也是美国医保体系对药价的极致压缩与患者用药可及性之间永不停歇的角力。 对于身处其中的企业而言，战略的真义从来不是选择一个正确的方向，而是在诸多结构性约束中找到那个可以持续生存的位置。仿制药行业的特殊性在于，它的存在本身就是对创新药定价的一种制衡，是医疗系统得以运转的压舱石。那些能在极低利润空间中活下来、并且活得不错的企业，一定是在成本、技术、规模、合规的复杂方程中，找到了属于自己的最优解。 话说，中国仿制药又该如何呢？ 参考文献 DOSE OF REALITY: GENERIC AND BIOSIMILAR COMPETITION GENERATES SIGNIFICANT SAVINGS FOR PATIENTS AND THE U.S. HEALTH CARE SYSTEM International Prescription Drug Price Comparisons: Estimates Using 2022 Data Innovation and Access: How Teva Is Developing the Next Generation of Medicine Zacks Industry Outlook Highlights Sandoz, Teva Pharmaceuticals and Dr. Reddy's FDA批准73款生物类似药，仅66%商业化！从修美乐看市场困境 Amgen Charts Growth Strategy Amid Patent Cliff: Biosimilars and Therapeutic Innovation Take Center Stage 立即扫码加入药事纵横交流群