Aflibercept-abzv

Alteogen Inc.    专注于“生物改良药”和药物递送技术，核心是利用重组人透明质酸酶（rHuPH20），将静脉注射药物转化为皮下注射（SC）制剂，当前聚焦肿瘤领域，顶级药企背书，风险共担 + 高收益。劣势是相较于行业巨头 Halozyme（ENHANZE®/rHuPH20），缺乏独立的全球商业化能力，高度依赖于大药企合作伙伴，也面临激烈的技术与市场竞争风险。    Alteogen/알테오젠 公司在2008年5月成立，是一家技术平台型生物企业，致力于研发疗效优于现有生物药的“新一代Biobetter”，以及与现有生物药疗效相当的“Biosimilar”，核心是做“平台型”技术输出与合作开发，而不是只做单一产品的药企。总部位于韩国大田广域市儒城区，员工150+人。创始人是Park Soon-jae和Chung Hye-shin，二人是夫妻。Park负责整体战略、BD、对外合作与公司经营管理，Chung负责核心技术尤其是长效蛋白技术 NexP™ 的开发与科研方向。主要管线方向是平台输出型业务，围绕三大平台（长效、ADC、皮下给药三大技术平台）持续迭代和扩展，通过向全球大药企授权平台（尤其是 Hybrozyme），让更多大分子生物药能实现皮下给药和/或长效化。2025年前三季度累计营收同比增长190.9%、营业利润同比增长3575.7%、净利润同比增长727.6%。 • 2020年，经欧盟EC批准，曲妥珠单抗生物类似药（Herceptin® biosimilar），用于HER2阳性早期/转移性乳腺癌、HER2阳性转移性胃癌等（与原研 Herceptin® 相同的适应症范围） • 2024年，经韩国MFDS批准，Tergase®（重组人透明质酸酶，ALT-BB4），用于提升皮下/肌肉注射、局部麻醉药及皮下输注时的组织渗透；促进过多组织液与血液的再吸收（辅助/扩散剂用途） • 2024年9月（美国FDA批准），2025年11月（欧盟批准），KEYTRUDA SC™（帕博利珠单抗皮下制剂），用于原研Keytruda®（帕博利珠单抗）在成人中的全部33个适应症（多种实体瘤与适应症），以皮下（SC）替代静脉（IV）给药。Alteogen提供rHuPH20重组人透明质酸酶作为Hybrozyme™平台输出，与 MSD合作将IV Keytruda改造为SC剂型。 • 2025年9月（欧盟批准），EYLUXVI®（阿柏西普生物类似药，ALT-L9，玻璃体腔内注射），用于湿性年龄相关性黄斑变性（wAMD）、视网膜静脉阻塞（RVO）后的黄斑水肿、糖尿病黄斑水肿（DME）、近视性脉络膜新生血管（myopic CNV）。Alteogen通过“完全自主内部研发”完成候选分子和工艺，与子公司Alteogen Biologics共同完成全球临床开发，被视为其首款“完全自主开发并获批”的生物类似药产品。 战略与商业模式 1. 技术平台优先 明确把“平台”而非单个产品视为核心竞争力： NexP™：围绕长效化，持续拓展可融合的蛋白/多肽种类。 NexMab™：强化 ADC 的稳定性与可制造性，降低成本。 Hybrozyme™：推动 IV→SC 的“给药方式范式转换” 2.混合商业模式，核心是“平台许可+内部开发”双驱动： （1）自研：NexP 长效平台、NexMab ADC管线、自有制剂Tergase等 （2）对外合作：通过Hybrozyme与多家跨国药企合作，负责配方和部分开发，由合作方负责临床与商业化。 核心领域及核心产品 1. ALT-B4（rHuPH20，Hybrozyme™ 平台核心）    并不单独治疗疾病，而是作为“SC 给药 enabling 技术”，与大分子单抗/融合蛋白联用，把静脉（IV）制剂转化为皮下（SC）或大容量皮下输注，缩短给药时间、提升患者便利性，适用于多种合作方的产品，如MSD的Keytruda®（帕博利珠单抗）等。与MSD合作：Keytruda Qlex™（帕博利珠单抗+rHuPH20）已在2024年9月获FDA批准、2025年11月获EC批准，覆盖原研Keytruda®全部成人适应症（33个）的SC给药。ALT-B4作为Hybrozyme™平台，已授权给6家合作方；MSD的Keytruda Qlex已获FDA批准并上市销售”；其他合作公开报道包括：Enhertu® SC（第一三共/曲妥珠单抗的冻干粉）等项目也在使用ALT-B4技术。    临床试验逻辑：依赖药代动力学、疗效与安全性对照，证明SC剂型在相同给药频率下与IV Keytruda®“生物等效/非劣效”，并评估注射部位反应和便利性。以下作图是K药的销售趋势和展望，右图是PD-1/L1的销售趋势和展望。 2. ALT-BB4/Tergase®（单方制剂-重组人透明质酸酶）    用于提升皮下/肌肉注射或局部麻醉药的组织渗透与扩散；促进过多组织液/血液的再吸收；作为辅助/扩散剂（例如在大容量皮下输注前预处理注射部位），已在韩国本土商业化（医院/诊所渠道），用于皮肤科、整形外科、术后消肿镇痛及局部给药扩散等场景。用法：可与麻醉药品先后注射，也可与麻醉药品混合使用，具体根据麻醉药物不同可选择不同方式使用。 3. ALT-L9/EYLUXVI®（阿柏西普生物类似药，玻璃体球内注射，与原研制剂无区别）    适应症与原研Eylea®（aflibercept）一致，包括：新生血管性（湿性）年龄相关性黄斑变性（wAMD）；视网膜静脉阻塞（RVO，包括BRVO和CRVO）后的黄斑水肿；糖尿病黄斑水肿（DME）；近视性脉络膜新生血管（myopic CNV） III期等效/桥接试验（简要）：在12个国家开展多中心、随机、双盲、等效性/桥接III期，对比ALT-L9与Eylea®在wAMD/RVO/DME 等患者中的疗效与安全性；主要终点：第16/36周最佳矫正视力（BCVA）变化等。证明在关键疗效终点上与原研“临床等效”，安全性与免疫原性谱与原研相似，为EYLUXVI®在欧盟及后续其他国家上市提供完整证据基础。以下是生物类似药物的销售额。 4. ALT-P1（长效人生长激素，hGH-NexP™）    适应症是成人生长激素缺乏症（成人GHD）；儿童生长激素缺乏症（儿童GHD）。利用NexP™长效平台，将人生长激素与人α1‑抗胰蛋白酶（A1AT）载体融合，延长半衰期，目标为“每周一次”给药，改善目前每日注射的依从性。韩国完成成人IIa期临床（剂量探索、PK/PD、安全性与IGF-1等指标）；儿童患者II期（未治疗青春期前儿童GHD）已完成；显示在IGF-1升高与生长速率等方面与现有疗法“可比且安全”。正在准备“全球II期/III期”，计划推进更多国家注册，获FDA孤儿药资格（ODD）用于儿童GHD。II期成人GHD（37例）与儿童GHD（53例未治疗）：成人与儿童队列中，IGF-1水平升高与生长速度改善与每日hGH制剂“相当”，安全性与每日注射对照组无显著差异，最常见AE为一过性注射部位反应或轻度关节/肌肉痛。    全球人生长激素（HGH）市场规模在2022年约49亿美元，预计以8%的年复合增长率（CAGR）增长，2032年将达108亿美元。主要增长驱动因素是临床应用拓展（儿童生长不足、特纳综合征、成人相关疾病），以及长效剂型等创新产品的推动。ALT-P1是一款每周一次注射的人生长激素，已获FDA孤儿药资格认定。ALT-P1的2期初步结果（针对儿童生长激素缺乏症pGHD患者） 核心指标：第13周的年身高增长速度（AHV） 组别 AHV（厘米） 标准差（SD） ALT-P1 0.6 mg/kg 11.68 1.4 ALT-P1 0.8 mg/kg 10.34 1.67 对照药 Genotropin（每日一次） 10.32 0.88 每周一次的ALT-P1，其疗效与每日一次的Genotropin相当。针对pGHD患者的2期试验仍在进行中，预计2026年读出结果。 5. ALT-P7（HER2-ADC，NexMab™）    适应症是HER2阳性晚期/转移性乳腺癌、HER2阳性胃癌。该药物抗体部分：Alteogen自研的trastuzumab biobetterHM2，基于NexMab™平台进行位点特异性偶联，改善ADC稳定性与药效。已经在HER2阳性乳腺癌中，完成“首次人体（FIH）I期剂量爬坡试验（开放标签、单臂），入组经多线治疗（含曲妥珠单抗、帕妥珠单抗、T-DM1等）的晚期患者。但未进入快速II/III期推进，目前处于平台优化/再评估阶段，重点在ADC技术迭代与安全性窗口优化。 • 核心领域：主要集中在肿瘤、眼科、生长激素缺乏症等，下一步打算在肥胖领域研发长效药物。 该公司可能并非聚焦疾病领域，而是根据现有热点浪潮，通过该公司的三大核心技术进行转换。 不同皮下制剂对比 （1）皮下ICI（恩沃利单抗，PD-L1，sc）0.75ml每支，≥13秒，小体积、高浓度、不含透明质酸酶的单抗制剂，靠的是高溶解度完成皮下注射，但高浓度会导致制剂稳定性和注射部位耐受性差 （2）奥曲肽，采用预充针，奥曲肽是小分子多肽，皮下注射后经毛细血管进入血液，皮下吸收快且完全，长效是利用聚合物微球缓慢释放的机制 （3）免疫球蛋白也从IV→SC，用在免疫球蛋白领域的代表产品是Takeda的HYQVIA（IgG10%+rHuPH20）,此外，BMS的Opdivo Qvantig（nivo皮下制剂）、Roche的Tecentriq Hybreza（atezo皮下制剂）均采用Halozyme公司的 ENHANZE® 技术平台，也就是重组人透明质酸酶 rHuPH20。 默沙东的K药皮下制剂（Keytruda QLEX）其实“同样用了透明质酸酶这条路子”，但选择的合作伙伴是韩国Alteogen（ALTB4/Hybrozyme™），而不是Halozyme的ENHANZE®。主要原因有三： （1）专利与法律风险不想完全落在Halozyme头上； （2）想拿到更“独家”的供应链与控制权，而不是在已经有众多大厂绑定/竞争的ENHANZE生态里排队； （3）Alteogen在合作条款、独家授权与技术定位上，更贴合默沙东“把K药做成全新、长专利期的SC品牌”的战略需求。 除上述2家有rHuPH20技术平台外，还有中国复宏汉霖（2025年宣布Henozye®技术平台）、宝济药业（Hysorptase®，在2024年向NMPA提出NDA受理）、韩国Huonslab（Huons Global 子公司，HyDIFFUZE™ 平台，2025年提供该平台的BLA），均是rHuPH20的“新贵”。竞争压力大。 技术平台解读（三大核心技术平台） 1. NexP™ 融合技术（长效） 该平台属于第二代长效化技术，利用人血液中丰富的α1抗胰蛋白酶（A1AT）作为重组蛋白载体，把目标蛋白或多肽融合在C端或N端，从而延长半衰期，在保持药物活性的前提下实现长效给药，减少给药频次。如ALT-P1（长效人生长激素，hGH-NexP™），将每天给药，目标变成每周给药。该平台仅能助力长效，不能改变用药剂型。NexP™技术的本质是将治疗性蛋白（如生长激素、抗体片段）与人体天然蛋白 A1AT（α1 - 抗胰蛋白酶）进行基因工程融合，利用 A1AT 的特性解决短效药物的两大核心痛点 ——“快速清除” 和 “易被降解”，具体通过 3 步实现长效： 第一步：借助 A1AT 的 “FcRn 再循环机制”，减少药物降解A1AT 是人体血清中含量丰富的天然蛋白，能与细胞内的FcRn 受体（新生儿 Fc 受体） 特异性结合—— 这一机制与抗体 Fc 片段、白蛋白的长效原理类似： • 当融合蛋白（治疗蛋白 - A1AT）被人体细胞内吞后，会被运输至溶酶体（正常情况下会被降解）； • 但在酸性的内吞环境中，A1AT 会与 FcRn 紧密结合，避免被溶酶体分解，反而被 FcRn “转运回细胞外”； • 回到中性的血液环境后，融合蛋白与 FcRn 解离，重新进入血液循环发挥作用，形成 “循环 - 复用” 模式，大幅延长药物在体内的留存时间。 第二步：增大分子体积，减缓肾脏清除短效药物（如小分子多肽、生长激素）因分子量小（通常 < 50kDa），易被肾脏通过肾小球滤过清除。NexP™通过将治疗蛋白与 A1AT（分子量约 52kDa）融合，使融合蛋白总分子量提升至 100-150kDa，远超肾脏滤过阈值（约 50kDa），从而显著降低肾脏清除速率，延长药物半衰期（临床前数据显示，生长激素经 NexP™改造后，半衰期从 1-2 小时延长至 72 小时以上）。 第三步：结构优化保留药效，避免活性损失融合过程中通过“内在活性缺失设计（Deletion of intrinsic activity） ”，仅保留 A1AT 的 “FcRn 结合结构域” 和 “稳定骨架”，删除其自身的蛋白酶抑制活性 —— 既避免 A1AT 的活性干扰治疗蛋白功能，又确保融合蛋白能正常与 FcRn 结合，实现 “长效” 与 “药效” 的平衡（如 ALT-P1，即 NexP™改造的生长激素，临床 1 期显示其促生长活性与短效生长激素无显著差异）。 对比维度 NexP™融合技术（A1AT 融合） 传统 PEG 化技术 普通 Fc 融合技术 作用机制 FcRn 再循环 + 增大分子量 仅增大分子量（物理屏障） FcRn 再循环 免疫原性 极低（A1AT 为人体天然蛋白，无外源成分） 较高（PEG 为化学合成物，易引发抗 PEG 抗体） 中等（Fc 片段可能引发抗抗体反应） 对药效影响 无影响（删除 A1AT 活性，不干扰治疗蛋白） 较高（PEG 为化学合成物，易引发抗 PEG 抗体） 可能影响（Fc 片段可能改变药物靶向性） 适配药物类型 多肽、细胞因子、抗体片段（分子量 < 100kDa） 小分子多肽、酶类（需避免活性位点修饰） 抗体、大分子融合蛋白（分子量较大） 临床优势 可长期给药 短期治疗（如抗肿瘤酶，避免长期免疫反应） 中短期治疗（如抗体药物，避免抗 Fc 抗体积累） 代表药物 ALT-P1 NovoEight®（PEG 化凝血因子 Ⅷ） rFⅧFc（Fc 融合凝血因子 Ⅷ） 2. NexMab™ ADC技术（ADC） 该平台强调“更优的稳定性、效力与经济性”，希望在提高药效的同时降低生产成本，用于开发高选择性的ADC候选药物，如ALT-P7（HER2-ADC，NexMab™）。 连接子（Linker）设计：可切割型肽连接子，组织蛋白酶敏感型肽连接子（如 Val-Cit、Val-Ala）,具有高稳定性连接子。中等 DAR（4–6）.以下是几个主要ADC平台的对比 Alteogen NexMab™ 第一三共 DXd-ADC 平台（如 Enhertu） Halozyme Enhanze® ADC（联合平台） Seagen ADC 平台（如 Padcev） 核心技术 可切割肽连接子 + 中等 DAR（4–6）+ 皮下递送兼容 可切割肽连接子 + 高 DAR（8）+ 强效 DXd 载荷 透明质酸酶 PH20+ADC 共递送（无自有 ADC 连接子 / DAR 设计） 可切割肽连接子 + 低 DAR（4）+MMAE 载荷 连接子类型 组织蛋白酶敏感型肽连接子 组织蛋白酶敏感型肽连接子（如 GGFG） 无自有技术 组织蛋白酶敏感型肽连接子（Val-Cit） DAR 值 4.0–6.0 8.0 4 4 毒性控制优势 1. 中等 DAR 减少抗体聚集 / 脱靶毒性；2. 皮下给药降低 IRR（<5%）；3. 无新增独特毒性 1. DXd 载荷抗肿瘤活性强；2. 但高 DAR 可能增加胃肠道毒性 / ILD 风险 1. 仅优化递送效率；2. 不改善 ADC 本身毒性 1. 技术成熟；2. 但 MMAE 载荷神经毒性 / 骨髓抑制发生率较高（15%–25%） 适配药物类型 实体瘤（HER2、Nectin4、Trop-2） 实体瘤（HER2、HER3、Trop-2） 各类 ADC（仅提供递送支持） 实体瘤 / 血液瘤 临床差异化亮点 兼容皮下给药，提升患者依从性；与Enhertu 合作验证安全性（SC 制剂毒性更低） 强效载荷覆盖 HER2 低表达人群 不改变 ADC 本身疗效 / 毒性 首个 Nectin4 ADC（Padcev）获批 专利壁垒 连接子 + PH20 变体双专利（至 2040 年后） 连接子 + DXd 载荷专利（至 2035 年后） PH20 酶专利（2030 年到期） 连接子 + MMAE 偶联专利（部分到期） 根据ADC的毒性特性，Altegen正在寻求改变ADC SC配方。静脉给药迅速达到最高血药浓度（Cmax），但很难维持稳定的血药浓度。皮下制剂在快速有效性方面落后，但具有保持体内药物浓度恒定的优势。随着ADC市场的增长，关于配方变化的研究也在进行中。目前，SC配方中还没有开发出ADC药物，因此有各种研究结论。以下是静脉和SC ADC的PK差异 以上是ADC-SC的PK变化，且耐受值增加 3. Hybrozyme™ 技术（重组人透明质酸酶平台，改IV为SC） 该技术属于可把静脉输注（IV）的大分子生物药，转为皮下注射（SC）的“给药路径”平台技术。利用重组人透明质酸酶，暂时降解细胞外基质中的透明质酸，增大皮下给药的扩散体积与吸收速度，从而在不改变药效的前提下把 IV 改为 SC。透明质酸酶是指一种在细胞外基质中水解透明质酸的酶。该公司的配方变更平台“Hybrozyme”是一种使用Domaine和技术开发的改进的PH20变体，允许皮下修正。 透明质酸酶原理如上。通过“酶解 - 递送” 两步机制解决大分子给药路径。酶解屏障，打开药物通道，通过结构域交换技术（Domain Swap） 优化酶结构，可高效水解皮下组织中的透明质酸（HA）—— 这种成分是皮下间隙的 “天然屏障”，酶解后能暂时降低组织黏度、增加通透性，将皮下可注射体积从 2mL 提升至 5-20mL，让单抗、ADC 等大剂量大分子药物可顺利注入。这种成分是皮下间隙的 “天然屏障”，酶解后能暂时降低组织黏度、增加通透性，将皮下可注射体积从 2mL 提升至 5-20mL，让单抗、ADC 等大剂量大分子药物可顺利注入。 优化递送，平衡“效率与安全”，酶解仅持续 24 小时（HA 会自然再生），避免长期破坏组织结构；同时，改良后的 PH20 变体可与主药（如 Keytruda、Enhertu）共注射，通过 “局部作用 + 快速扩散” 提升药物生物利用度（临床前数据显示与静脉给药 PK 相似），且不影响主药的靶向性与疗效。以下目前几家透明质酸酶平台公司的对比，该公司的平台优势是热稳定性高、0 ADA、适配单抗/ADC/双抗等 Alteogen（Hybrozyme™/ALT-B4） Halozyme（ENHANZE®/rHuPH20） 复宏汉霖（Henozye®） 宝济（Hysorptase®） Huonslab（HyDIFFUZE™） 分子设计 人源 PH20 域交换改造，99%+ 纯度，热稳定性提升，货架期更长 野生型 rHuPH20，专利聚焦酶 - 药物共制剂 AI 辅助优化 PH20，侧重生物类似药适配 哺乳动物细胞表达 rHuPH20，聚焦大容量皮下输注（最高 1L） 发酵工艺优化 PH20，主打医美与局部麻醉应用 免疫原性 临床 0 ADA 发生率，高剂量下注射部位反应（ISR）更低 低免疫原性，但长期大剂量下偶见 ADA 临床数据待完善，强调与自有抗体协同 低免疫原性，与自研抗体共制剂开发中 数据有限，侧重局部应用安全性 给药能力 支持大体积皮下注射，适配 ADC/PD-1 /双抗等大分子，已验证 Enhertu、dostarlimab 等管线 支持 10-15mL，以单抗共制剂为主（如 Herceptin SC） 适配自有生物类似药（曲妥珠单抗等），体积≤10mL 支持大容量输注，主打慢病与抗体共制剂 以小体积（≤5mL）医美 / 局麻为主 商业化路径 全球顶级药企授权（阿斯利康、第一三共、GSK/Tesaro），聚焦肿瘤领域，形成“肿瘤领域首选透明质酸酶” 的品牌认知 广泛授权（罗氏、强生等），覆盖肿瘤 / 免疫 / 慢病，平台费 + 分成 自有产品优先，逐步对外授权，聚焦中国市场 国内合作（尚健生物等），申报 NDA，布局中国医保 韩国本土医美为主，逐步拓展海外局部市场 三个平台均有上市药物，但公司未披露是否下一步进行平台联合，例如，将某个静脉药物转换长效且皮下药物、或皮下ADC等。这也是其他平台所不具备的多平台能力。 近5年交易情况 2021年1月：Intas Pharmaceuticals（印度）——ALT-B4用于两款产品的SC制剂    Intas Pharmaceuticals（总部在印度的跨国仿制/生物类似药企，旗下有Accord Healthcare等子公司在欧美销售），ALT-B4（Hybrozyme）用于“两款产品”的SC制剂开发与商业化（具体产品名称未公开披露），首付款：600万美元；里程碑：后续开发、注册与销售里程碑总计最高1.09亿美元。将ALT-B4平台拓展到新兴市场和仿制/生物类似药巨头。 2023年1月：Sandoz（山德士）——ALT-B4用于其生物类似药SC制剂    Sandoz AG（诺华旗下的全球生物类似药龙头），使用ALT-B4将Sandoz的一款生物类似药从IV改为SC。权利：Sandoz取得ALT-B4在该生物类似药上的全球使用权。标志ALT-B4平台进入主流生物类似药玩家管线，与Sandoz在全球多个高监管市场的布局，大幅提高平台曝光度和潜在市场体量。 2024年2月：MSD（Merck）——修订ALT-B4合同为全球独占，支撑Keytruda SC    采用Alteogen 的重组人透明质酸酶ALT-B4（Hybrozyme平台）。2020 年双方签署的是“非独占（non‑exclusive）”技术许可；当时并未公开点名MSD，只说明合作用于一款肿瘤免疫治疗大药的SC制剂（后公开为Keytruda），2024年2月双方对合同进行修订，改为“全球独占”，同时确认用于Keytruda（Qlex™）的SC制剂。首付款：2,000万美元；监管与销售里程碑：最高4.32亿美元（基于产品获批与销售目标）。这是Alteogen规模最大、影响力最强的单笔交易之一，将ALT-B4固化为与全球PD-1头牌药物绑定的“标准助推器”。 2025年3月：AstraZeneca——ALT-B4用于多款肿瘤资产的SC制剂    ALT-B4（Hybrozyme 平台）用于AZ管线中“多款肿瘤资产的SC制剂开发与商业化”（具体产品未公开点名）。 公司核心价值评价 1. Hybrozyme™ 平台：该平台的核心是ALT-B4，临时降解皮下间质中的透明质酸，增大组织“自由空间”，让大体积能在有限时间内吸收，又不至于造成过分高的组织压，目前为传统安瓶+注射器，每支2.4ml，1min注射，是以酶为“促渗剂”，增大皮下可容纳体积和吸收速度，本身不改变现有分子、不更换给药频率。 2. 多元化技术组合：除Hybrozyme外，还有长效蛋白平台NexP™（如长效人生长激素ALT-P1）和ADC平台NexMab™（如HER2-ADC ALT-P7），实现“多点下注”。 END 扫码关注 医药投资并购俱乐部 获得更多讯息

Ad-hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules Media Release Sandoz delivers strong full-year results; guidance for 2026 reflects an expected acceleration in growth Basel, February 25, 2026 – Sandoz (SIX: SDZ; OTCQX: SDZNY), the global leader in affordable medicines, today presents its financial results for the full year and net sales for the fourth quarter of 2025. FINANCIAL RESULTS FY 2025 FY 2024 change USD m USD m USD % CC %1,2 CGR %3 Net sales 11,086 10,357 7% 5% 6% Generics 7,794 7,504 4% 2% 2% Biosimilars 3,292 2,853 15% 13% 18% Core EBITDA 2,405 2,080 16% 14% Core EBITDA margin 21.7% 20.1% Core diluted earnings per share USD 3.64 USD 2.71 34% 33% Management free cash flow 1,547 1,112 39% Core return on invested capital 14.5% 12.3% Richard Saynor, Chief Executive Officer of Sandoz, said: “Our strong financial results in 2025 demonstrate the excellent headway we’re making. It was a year marked by the progress of our industry-leading pipeline, a record number of launches and significant investment in securing our biosimilars leadership for years to come. Our unrelenting focus on top-line growth, profitability and cash generation positions Sandoz well to deliver even more for patients and shareholders. “We will build on this momentum in 2026. Alongside our launch program, we plan to extend patient access, expand the pipeline and make further efficiency gains. As we cement our leadership in affordable medicines, we have an excellent platform to meet the unprecedented opportunities ahead and deliver strong results in a high-growth, attractive market.” 1 Constant currencies. 2 Non-IFRS measures are defined in the Supplementary financial information section of the Integrated Annual Report 2025. 3 Sandoz defines the comparable growth rate (CGR) as the growth rate of net sales at CC excluding the effects of material acquisitions and divestments. In the case of divestments, net sales are excluded for the corresponding period. Similarly, for acquisitions, the relevant net sales are excluded for the corresponding period. Material acquisitions and divestments are transactions in scope of significant transactions in the Company’s consolidated financial statements. Sandoz believes the presentation of CGR is meaningful for management and investors to evaluate the performance of the business over time. FINANCIAL HIGHLIGHTS FY 2025 net sales of USD 11.1 billion Up by 5% at CC and 7% in USD in the year, with volume growth of 8%; on a CGR basis, net sales grew by 6% Biosimilar sales up by 13% at CC in the year and by 18% at CGR; generics growth of 2% at CC and CGR The biosimilar share of total net sales increased to 30% (FY 2024: 28%) The 10 largest-selling medicines grew by a combined 10% at CC in the year and represented 33% of net sales In the fourth quarter, net sales of USD 3.0 billion represented growth of 6% at CC and 12% in USD; on a CGR basis, net sales grew by 7% in the quarter Core EBITDA-margin expansion in FY 2025 of 160 basis points to 21.7%, driven by a favorable mix of sales, operational efficiencies and cost discipline Core diluted earnings per share in the year up by 33% at CC to USD 3.64, mainly benefitting from growth in core net income Management free cash flow, defined as free cash flow adjusted for one-off items, amounted to USD 1.5 billion (FY 2024: USD 1.1 billion), with the increase primarily driven by the growth in core EBITDA A core return on invested capital (ROIC) of 14.5% in FY 2025 (FY 2024: 12.3%), principally a result of the strong growth in core operating income A proposed dividend per share of CHF 0.804 (FY 2024: CHF 0.60), representing 27% of core net income Full-year 2026 guidance of mid-to-high single-digit net-sales growth5 and core EBITDA-margin expansion of around 100 basis points Up by 5% at CC and 7% in USD in the year, with volume growth of 8%; on a CGR basis, net sales grew by 6% Biosimilar sales up by 13% at CC in the year and by 18% at CGR; generics growth of 2% at CC and CGR The biosimilar share of total net sales increased to 30% (FY 2024: 28%) The 10 largest-selling medicines grew by a combined 10% at CC in the year and represented 33% of net sales In the fourth quarter, net sales of USD 3.0 billion represented growth of 6% at CC and 12% in USD; on a CGR basis, net sales grew by 7% in the quarter BUSINESS HIGHLIGHTS 2025 was a milestone year for Sandoz, marked by a wave of launches across biosimilars and generics, significant progress on the transformation journey and strong financial results. The biosimilars business continued to perform strongly, supported by major launches: Pyzchiva® (ustekinumab) was launched in the US in February 2025, offering new treatment options for around 12 million patients with chronic inflammatory diseases such as psoriasis and psoriatic arthritis. The rollout included a full suite of dosing options and extended stability compared to the reference medicine The Pyzchiva autoinjector was launched in Europe in May 2025, the first ustekinumab biosimilar in Europe available in a pre-filled pen, with an improved self-administration experience supporting better treatment adherence and quality of life Wyost® & Jubbonti® (denosumab) were launched in the US in June 2025 as the first FDA6-approved interchangeable denosumab biosimilars, providing affordable treatment options for osteoporosis and cancer-related skeletal events, cementing Sandoz’s leadership in oncology and immunology biosimilars Tyruko® (natalizumab) was launched in the US in November 2025 as the first and only multiple-sclerosis biosimilar, approved for all indications of the reference medicine Afqlir® (aflibercept) was launched in Europe in November 2025, offering an affordable-treatment option for retinal diseases such as neovascular age-related macular degeneration, expanding Sandoz’s presence in the ~USD 15 billion anti-VEGF7 market Wyost & Jubbonti were launched in Europe in December 2025 In November 2025, Sandoz signed a global license agreement with EirGenix Inc. to commercialize a proposed biosimilar of pertuzumab for HER2‑positive early and metastatic breast cancer, a market worth approximately USD 4.1 billion8, strengthening the Company’s oncology portfolio and complementing its trastuzumab biosimilars. In December 2025, Sandoz completed the strategic acquisition of Just-Evotec Biologics EU SAS, including a site in Toulouse, France, expanding in-house development and manufacturing capabilities. In addition, Sandoz acquired an indefinite license to Just-Evotec Biologics, Inc.’s cutting-edge continuous-manufacturing technology. These acquisitions complemented ongoing investments in Slovenia, as Sandoz builds a vertically integrated European biosimilar development and manufacturing network. In 2025, Sandoz increased the availability of affordable medicines through several important generic launches, including rivaroxaban in Germany, expanding access to high-quality antithrombotic treatment options with multiple dosage forms. In September 2025, Sandoz launched its iron-sucrose injection in the US, broadening access to affordable treatment for iron-deficiency anemia in patients with chronic kidney disease and complementing its injectable iron-therapy portfolio. The Sandoz pipeline is industry‑leading, with 27 biosimilar assets and around 400 generics in development, targeting around USD 420 billion in originator sales. In 2025, the pipeline benefited from positive shifts in regulatory streamlining across key biosimilar programs - developments that are expected to deliver meaningful advantages for both patients and Sandoz. 4 Subject to approval at the Annual General Meeting on April 9, 2026. 5 At CC. 6 US Food & Drug Administration. 7 Vascular endothelial growth factor. 8 Evaluate Pharma, Summary: worldwide sales (last accessed November 2025). FULL-YEAR 2026 GUIDANCE Sandoz anticipates an acceleration of net-sales growth in 2026, partly reflecting the expected performance of recently launched biosimilars. This growth, alongside a favorable movement in the mix of sales, further operating efficiencies and cost discipline, is expected to result in expansion in the core EBITDA margin. As a result, the Company provides its financial guidance for 2026: Net sales to grow at CC by a mid to high single-digit percentage Core EBITDA-margin expansion of around 100 basis points Core EBITDA-margin expansion of around 100 basis points No material contribution from any potential launch of generic semaglutide is expected in 2026, while overall pricing is expected to decline by a low to mid single‑digit percentage. The guidance excludes any impacts of unforeseen events or unconfirmed developments, including the imposition of new tariffs emanating from the US government. PENICILLINS: TRADE DISTORTION As part of its vertically integrated penicillins production, the Company sells certain amounts of active pharmaceutical ingredients (APIs) to other businesses. The imposition of tariffs by the US government in 2025 led to reduced exports from China to the US, prompting Chinese suppliers to significantly lower global prices for key penicillin APIs, including 6‑Aminopenicillanic acid (6‑APA), the foundational compound for all penicillins. This price decline coincided with an increase in global market supply. These dynamics adversely impacted the Sandoz generics net-sales performance in H2 2025; a similar impact is expected in the first half of 2026. No imminent return to prior market conditions is anticipated. The recently announced introduction of a minimum import price of 6‑APA in India is expected to curb the inflow of low‑priced imports, primarily from China, and support the domestic fermentation‑based antibiotic production in India. This risks a diversion of the supply of low-cost 6-APA towards Europe, which continues to depend on Asia for key intermediates. CONFERENCE CALL A conference call and webcast for investors and analysts will begin today at 9.30am CET. Details can be found here, with the accompanying presentation here. NOTES The performance shown in this announcement covers the twelve-month period ended December 31, 2025 (FY 2025), the six-month period ended December 31, 2025 (H2 2025) and the three-month period ended December 31, 2025 (Q4 2025), compared to the twelve-month period ended December 31, 2024 (FY 2024), the six-month period ended December 31, 2024 (H2 2024) and the three-month period ended December 31, 2024 (Q4 2024), respectively. Commentary is based on the performance in FY 2025, unless stated otherwise. In this announcement, ‘Company’ refers to Sandoz Group AG. Over one billion patients were reached by Sandoz in 2025, including an estimated 0.2 billion patients reached through API sales. INTEGRATED ANNUAL REPORT Sandoz published its Integrated Annual Report 2025 today, which can be found here. CALENDAR The Company intends to publish its first-quarter sales update on April 29, 2026. CONTACTS Media Relations Investor Relations global.mediarelations@sandoz.com investor.relations@sandoz.com Alex Kalomparis+41 79 279 02 85 Craig Marks+44 7818 942 383 Gregor Rodehueser+49 170 574 3200 Tamara Hackl+41 79 790 52 17 Danja Spring+41 79 156 74 88 Silvia Siegfried+41 79 795 90 61 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 section of the 2025 Integrated Annual Report. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 colleagues of 100 nationalities work together to ensure over one billion patients are reached by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 medicines addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. In 2026, Sandoz celebrates 20 years of pioneering biosimilars, 80 years of antibiotics manufacturing and 140 years of heritage. FULL-YEAR AND FOURTH-QUARTER NET SALES NET SALES BY BUSINESS FY 2025 FY 2025 % of FY 2024 change USD m net sales USD m USD % CC % CGR % Generics 7,794 70% 7,504 4% 2% 2% Biosimilars 3,292 30% 2,853 15% 13% 18% Net sales 11,086 100% 10,357 7% 5% 6% Net sales amounted to USD 11.1 billion, reflecting growth of 5% at CC and 6% at CGR. Volumes grew by 8%, partly offset by price erosion of 3%. Net-sales growth was primarily driven by the strong performance of biosimilars, which continued to benefit from an extensive pipeline and launch program. Generics overview Net sales of generics amounted to USD 7.8 billion, reflecting growth of 2% at CC and CGR. Generics represented 70% of net sales in the year (FY 2024: 72%). The increase in net sales of generics in Europe of 2% at CC and CGR was driven by the impact of launches in 2024 and 2025. International net sales of generics grew by 2% at CC and by 4% at CGR, after adjusting for the 2024 divestment of the Sandoz business in China; sales benefited from continued price increases and launches. In North America, net sales of generics were stable at CC and CGR, with the impact of strong levels of competition offset by the impact of the successful Q4 2024 US launch of paclitaxel, as well as a good performance in Canada. Biosimilars overview Net sales of biosimilars amounted to USD 3.3 billion in the year, reflecting growth of 13% at CC and 18% at CGR; biosimilars represented 30% of total net sales (FY 2024: 28%). Strong Europe biosimilars net-sales growth of 14% at CC and CGR reflected several good performances, including Pyzchiva, Binocrit® (epoetin alfa) and Hyrimoz® (adalimumab). Afqlir, Wyost & Jubbonti were launched in Europe in Q4 2025. International biosimilar net-sales growth of 30% at CC and CGR reflected strong contributions from Omnitrope® (somatropin) and Hyrimoz. Wyost & Jubbonti were launched in Q3 2025 in the International region. North America biosimilar net sales grew by 2% at CC and by 19% at CGR, with the difference reflecting the withdrawal of Cimerli® (ranibizumab) in Q1 2025. The strong underlying performance was partly a result of the successful launch of Wyost & Jubbonti in Q2 2025. Tyruko was launched in the US in Q4 2025. Q4 2025 Q4 2025 % of Q4 2024 change USD m net sales USD m USD % CC % CGR % Generics 2,095 69% 1,946 8% 2% 2% Biosimilars 934 31% 769 21% 16% 20% Net sales 3,029 100% 2,715 12% 6% 7% Net sales for the fourth quarter were USD 3.0 billion, reflecting growth of 6% at CC and 7% at CGR. Volumes grew by 9%, partly offset by price erosion of 3%. NET SALES BY REGION FY 2025 FY 2025 % of FY 2024 change USD m net sales USD m USD % CC % CGR % Europe 5,936 54% 5,363 11% 6% 6% International 2,713 24% 2,557 6% 7% 9% North America 2,437 22% 2,437 0% 0% 5% Net sales 11,086 100% 10,357 7% 5% 6% Europe overview Net sales in Europe in the year amounted to USD 5.9 billion, reflecting growth of 6% at CC and CGR. Europe net sales of generics increased by 2% at CC and CGR, with biosimilars up by 14% at CC and CGR. Notable growth included that from Pyzchiva, Binocrit and Hyrimoz. International overview Net sales in International in the year amounted to USD 2.7 billion, with growth of 7% at CC and 9% at CGR. International net sales of generics grew by 2% at CC and by 4% at CGR, with biosimilars up by 30% at CC and CGR. The performance was supported by strong sales of Omnitrope and Hyrimoz. North America overview Net sales in North America in the year amounted to USD 2.4 billion, reflecting a stable performance at CC. Growth at CGR, namely excluding the impact of the acquisition of Cimerli, amounted to 5%. Generics net sales in the year were stable at CC and CGR, with the effects of strong levels of competition offset by the impact of the successful 2024 US launch of paclitaxel, as well as a good performance in Canada. North America biosimilar net sales grew by 2% at CC and by 19% at CGR. Q4 2025 Q4 2025 % of Q4 2025 change USD m net sales USD m USD % CC % CGR % Europe 1,574 52% 1,367 15% 6% 6% International 770 25% 653 18% 14% 14% North America 685 23% 695 -1% -2% 2% Net sales 3,029 100% 2,715 12% 6% 7% The table of net sales by region and by business can be found in the Supplementary financial information. The North America performance in the fourth quarter was adversely affected by the impact of a one-time generics gross-to-net adjustment in Q4 2024. FY 2025 OPERATING RESULTS FY 2025 FY 2024 change USD m USD m USD % CC % Net sales 11,086 10,357 7% 5% Gross profit 5,284 4,926 7% 5% EBITDA 1,980 820 nm9 nm Operating income 1,425 307 nm nm Core gross profit 5,613 5,253 7% 5% Core gross profit margin (%) 50.6% 50.7% Core EBITDA 2,405 2,080 16% 14% Core EBITDA margin (%) 21.7% 20.1% Core operating income 2,094 1,821 15% 13% Core operating income margin (%) 18.9% 17.6% 9Not meaningful. Core gross profit amounted to USD 5.6 billion (FY 2024: USD 5.3 billion), resulting in a core gross-profit margin of 50.6% (FY 2024: 50.7%). A favorable mix of sales, reflecting double-digit biosimilars growth, and operational improvements were offset by the impacts of inflation on the cost of goods sold and price erosion. Core EBITDA was USD 2.4 billion (FY 2024: USD 2.1 billion), resulting in a core EBITDA margin of 21.7% (FY 2024: 20.1%). The increase in the margin was partly driven by the impacts of cost discipline on selling, general & administrative expenses and favorable other income and expenses, partly offset by growth in development & regulatory investment. EBITDA was USD 1,980 million (FY 2024: USD 820 million). Core adjustments of EBITDA in the year were USD 425 million (FY 2024: USD 1,260 million). These adjustments primarily reflected separation costs of USD 336 million, costs of the rationalization of internal manufacturing sites of USD 92 million, software-implementation cost-accounting impacts of USD 43 million and favorable effects from adjustments for legal costs of USD 58 million. FY 2025 NON-OPERATING RESULTS FY 2025 FY 2024 change USD m USD m USD % CC % Net financial result (218) (318) 31% 36% Income taxes (293) 12 nm nm Net income 914 1 nm nm Diluted earnings per share USD 2.09 USD 0.00 nm nm Core net financial result (219) (325) 33% 36% Core income taxes (286) (320) 11% 12% Core effective tax rate (%) 15.3% 21.4% Core net income 1,589 1,176 35% 33% Core diluted earnings per share USD 3.64 USD 2.71 34% 33% The core net financial result was an expense of USD 219 million (FY 2024: expense of USD 325 million). The decline reflected an improved net-currency result, as well as lower net interest expenses mainly driven by the repayment of EUR and USD term loans and local debt. The core effective tax rate was 15.3% (FY 2024: 21.4%), a reflection of changes in the mix of profit, adjustments to provisions for uncertain tax positions and the reorganization of the intellectual-property structure within the Company. Core net income of USD 1.6 billion (FY 2024: USD 1.2 billion) primarily reflected an increase in core operating income, and a decline in the core net financial result and in core income taxes. Core diluted earnings per share of USD 3.64 (FY 2024: USD 2.71) benefited from an increase in core net income. The weighted average number of shares diluted was 436.8 million as of December 31, 2025, versus 434.0 million as of December 31, 2024. CASH FLOW FY 2025 FY 2024 change USD m USD m USD m Net cash flows from operating activities 1,594 656 938 Cash flows used for capital expenditures (711) (554) (157) Other investing cash flows (9) (4) (5) Free cash flow 874 98 776 Payments for legal settlements, fees and expenses 663 29 634 Payments from restructuring provisions 128 40 88 Separation costs 336 348 (12) Separation-related capital expenditures 90 89 1 Other payments and receipts10 (544) 508 (1,052) Management free cash flow 1,547 1,112 435 Sandoz generated net cash flows from operating activities of USD 1,594 million (FY 2024: USD 656 million). This was mainly driven by an increase in operating income and stable net working-capital levels versus December 31, 2024. Cash flows used for capital expenditures were USD 711 million (FY 2024: USD 554 million), reflecting an increase in purchases of property, plant & equipment and intangible assets. This included the Company’s ongoing investments in Slovenia, namely a new biosimilar drug-substance production center in Lendava, a biosimilar-development center in Ljubljana and a new production plant in Brnik. It also included separation-related investments in facilities and technology. Free cash flow amounted to USD 874 million (FY 2024: USD 98 million). The improvement was mainly due to increased net cash flows from operating activities, partly offset by the growth in cash flows used for net capital expenditures. Management free cash flow, defined as free cash flow adjusted for one-off items, amounted to USD 1,547 million (FY 2024: USD 1,112 million). The performance was primarily a result of the growth in core EBITDA. 10 In FY 2025, other payments and receipts included the disbursements from qualified settlement funds relating to government generic-pricing antitrust investigations, antitrust class actions, opioid litigations in the US, and the payment for a technology acquisition from Just-Evotec Biologics, Inc. In FY 2024, other payments and receipts included two deposited settlement amounts of USD 233 million and USD 275 million, related to government generic-pricing antitrust investigations and antitrust class actions in the US. CAPITAL RESOURCES Dec 31 2025 Dec 31 2024 change USD m USD m USD m Inventories 2,845 2,800 45 Trade receivables 2,508 2,205 303 Trade payables (1,850) (1,519) (331) Net working capital 3,503 3,486 17 Non-current financial debts and derivative financial instruments 4,700 4,390 310 Current financial debts and derivative financial instruments 614 145 469 Total financial debts 5,314 4,535 779 Derivative financial instruments (12) (15) 3 Cash and cash equivalents (1,739) (1,191) (548) Total current financial assets (1,751) (1,206) (545) Net debt 3,563 3,329 234 Net debt to core EBITDA ratio 1.5x 1.6x Core ROIC (%) 14.5% 12.3% Net working capital remained broadly stable year‑on‑year, despite strong sales growth. Total inventories increased by USD 45 million, with lower levels of inventory more than offset by currency-translation effects. Trade receivables increased by USD 303 million, with trade payables up by USD 331 million, primarily reflecting currency-translation effects. Non-current financial debts and derivative financial instruments increased by USD 310 million, a reflection of the issuance of three bonds in the first half of 2025, totalling EUR 500 million and CHF 400 million, respectively and currency-translation effects. This was partly offset by the repayment of USD 750 million equivalent in USD and EUR term loans, as well as the reclassification of USD 504 million from non-current to current financial debts of a CHF-denominated bond, maturing in 2026. Current financial debts and derivative financial instruments increased by USD 469 million, primarily a result of the reclassification of USD 504 million from non-current to current financial debts. Cash and cash equivalents increased by USD 548 million, as cash generated from operating activities and proceeds from the issuance of non-current financial debts were partly offset by the repayment of term loans, the annual dividend payment, purchases of property, plant & equipment, purchases of intangible assets and the acquisition of Just-Evotec Biologics EU SAS. As a result, net debt increased to USD 3,563 million (December 31, 2024: USD 3,329 million), mainly driven by currency-translation effects of USD 442 million. Excluding these effects, net debt amounted to USD 3,121 million. An increase in core ROIC to 14.5% (FY 2024: 12.3%) was a result of strong growth in core operating income and a lower core effective tax rate. DIVIDEND A dividend of CHF 0.60 per share in respect of the 2024 financial year was approved by the Annual General Meeting on April 15, 2025, and paid. A dividend proposal of CHF 0.80 per share in respect of the 2025 financial year, representing 27% of core net income, is subject to approval at the Annual General Meeting on April 9, 2026. SUPPORTING FINANCIAL INFORMATION 2025 NET SALES BY BUSINESS H1 2025 change H2 2025 change FY 2025 change USD m USD % CC % USD m USD % CC % USD m USD % CC % Generics 3,736 1% 1% 4,058 7% 2% 7,794 4% 2% Biosimilars 1,496 11% 12% 1,796 19% 14% 3,292 15% 13% Net sales 5,232 4% 4% 5,854 10% 6% 11,086 7% 5% BY REGION H1 2025 change H2 2025 change FY 2025 change USD m USD % CC % USD m USD % CC % USD m USD % CC % Europe 2,832 8% 6% 3,104 14% 6% 5,936 11% 6% International 1,284 1% 5% 1,429 11% 9% 2,713 6% 7% North America 1,116 -2% -1% 1,321 2% 2% 2,437 0% 0% Net sales 5,232 4% 4% 5,854 10% 6% 11,086 7% 5% BY REGION AND BUSINESS: H2 H2 2025 H2 2024 change USD m USD m USD % CC % CGR % Europe 3,104 2,729 14% 6% 6% Generics 2,095 1,888 11% 3% 3% Biosimilars 1,009 841 20% 11% 11% International 1,429 1,288 11% 9% 9% Generics 1,135 1,058 7% 5% 5% Biosimilars 294 230 28% 30% 30% North America 1,321 1,293 2% 2% 6% Generics 828 854 -3% -3% -3% Biosimilars 493 439 12% 12% 27% Net sales 5,854 5,310 10% 6% 7% Thereof: Total generics 4,058 3,800 7% 2% 2% Total biosimilars 1,796 1,510 19% 14% 18% BY REGION AND BUSINESS: FY FY 2025 FY 2024 change USD m USD m USD % CC % CGR % Europe 5,936 5,363 11% 6% 6% Generics 4,036 3,769 7% 2% 2% Biosimilars 1,900 1,594 19% 14% 14% International 2,713 2,557 6% 7% 9% Generics 2,154 2,113 2% 2% 4% Biosimilars 559 444 26% 30% 30% North America 2,437 2,437 0% 0% 5% Generics 1,604 1,622 -1% 0% 0% Biosimilars 833 815 2% 2% 19% Net sales 11,086 10,357 7% 5% 6% Thereof: Total generics 7,794 7,504 4% 2% 2% Total biosimilars 3,292 2,853 15% 13% 18% QUARTERLY 2025 NET SALES BY BUSINESS Q1 2025 change Q2 2025 change Q3 2025 change Q4 2025 change USD m USD % CC % USD m USD % CC % USD m USD % CC % USD m USD % CC % Generics 1,809 -3% 0% 1,927 5% 2% 1,963 6% 3% 2,095 8% 2% Biosimilars 671 8% 11% 825 15% 12% 862 16% 13% 934 21% 16% Net sales 2,480 0% 3% 2,752 8% 5% 2,825 9% 6% 3,029 12% 6% BY REGION Q1 2025 change Q2 2025 change Q3 2025 change Q4 2025 change USD m USD % CC % USD m USD % CC % USD m USD % CC % USD m USD % CC % Europe 1,372 3% 7% 1,460 12% 6% 1,530 12% 6% 1,574 15% 6% International 590 -8% -2% 694 11% 11% 659 4% 4% 770 18% 14% North America 518 -1% 1% 598 -4% -3% 636 6% 7% 685 -1% -2% Net sales 2,480 0% 3% 2,752 8% 5% 2,825 9% 6% 3,029 12% 6% QUARTERLY 2024 NET SALES BY BUSINESS Q1 2024 change Q2 2024 change Q3 2024 change Q4 2024 change USD m USD % CC % USD m USD % CC % USD m USD % CC % USD m USD % CC % Generics 1,869 0% 1% 1,835 -1% 1% 1,854 3% 4% 1,946 1% 4% Biosimilars 623 21% 21% 720 35% 37% 741 36% 37% 769 23% 25% Net sales 2,492 5% 6% 2,555 7% 9% 2,595 11% 12% 2,715 7% 9% BY REGION Q1 2024 change Q2 2024 change Q3 2024 change Q4 2024 change USD m USD % CC % USD m USD % CC % USD m USD % CC % USD m USD % CC % Europe 1,326 4% 2% 1,308 2% 3% 1,362 13% 12% 1,367 7% 8% International 642 4% 12% 627 5% 9% 635 2% 8% 653 0% 6% North America 524 6% 6% 620 22% 23% 598 17% 18% 695 13% 14% Net sales 2,492 5% 6% 2,555 7% 9% 2,595 11% 12% 2,715 7% 9% FY 2025: RECONCILIATION FROM IFRS RESULTS TO CORE RESULTS (USD millions unless indicated otherwise) IFRS results Amortization of intangibleassets11 Impair-ments12 Acquisition or divest-ment of businesses and related items13 Other items14 Core results Net sales 11,086 – – – – 11,086 Other revenues 71 – – – – 71 Cost of goods sold (5,873) 214 16 – 99 (5,544) Gross profit 5,284 214 16 – 99 5,613 Selling, general and administration (2,529) – – – 67 (2,462) Development and regulatory (1,050) – 2 – 2 (1,046) Other income 353 – – (10) (200) 143 Other expense (633) – – 12 467 (154) Operating income15 1,425 214 18 2 435 2,094 Interest expense (220) – – – – (220) Other financial income and expense 2 – – – (1) 1 Income before taxes 1,207 214 18 2 434 1,875 Income taxes16 (293) (286) Net income 914 1,589 Basic earnings per share (USD) 2.12 3.68 Diluted earnings per share (USD) 2.09 3.64 11 Amortization of intangible assets: cost of goods sold includes the amortization of rights to currently marketed products and other production-related intangible assets. 12 Impairments: cost of goods sold and development and regulatory include impairment charges related to intangible assets. 13 Acquisition or divestment of businesses and related items: other income includes a release related to the China business divestment; other expense includes costs related to the Just-Evotec Biologics EU SAS acquisition. 14 Other items: cost of goods sold, other income and other expense include the Company-wide rationalization of manufacturing sites; cost of goods sold, selling general and administration, development and regulatory, other income and other expense include the separation costs related to the spin-off; cost of goods sold, selling general and administration, development and regulatory, other income and other expense include the costs related to the transformation program and other restructuring charges; other income and other expense include legal-related charges and adjustments to contingent consideration; selling, general and administration includes software implementation cost accounting impacts; other expense includes an onerous contract adjustment; other financial income and expense includes the net monetary impacts on the restatement of non-monetary items for subsidiaries in hyperinflationary economies. 15 For further breakdown of core adjustments by category, refer to table ‘Reconciliation from IFRS operating income to core net income’. 16 Taxes on the adjustments between IFRS and core results take into account, for each individual item included in the adjustment, the tax rate that will finally, be applicable to the item based on the jurisdiction where the adjustment will finally have a tax impact. Generally, this results in amortization and impairment of intangible assets and acquisition-related restructuring and integration items having a full tax impact. There is usually a tax impact on other items, although this is not always the case for items arising from legal settlements in certain jurisdictions. Due to these factors and the differing applicable tax rates in the various jurisdictions, the tax on the total adjustments of USD 668 million to arrive at the core results before tax amounts to USD -7 million. The average tax rate on the adjustments was not meaningful.