Remibrutinib

2025年，诺华（Novartis）在全球医药行业面临专利悬崖和市场竞争加剧的背景下，实现了稳健的财务表现和管道突破。根据公司发布的2025年第四季度及全年财务业绩报告，全年净销售额达到545.32亿美元，按恒定汇率计算增长8%；核心营业利润率为40.1%，同比提升210个基点，体现了“纯创新药物公司”战略的有效性。第四季度销售额为133.36亿美元，受美国仿制药侵蚀和收入扣除调整影响，按恒定汇率计算微降1%，但核心产品如Kisgali、Kesimpta和Pluvicto均实现双位数增长。首席执行官Vas Narasimhan表示，公司通过聚焦四大核心治疗领域（心血管-肾脏-代谢、免疫学、神经科学和肿瘤学），成功推动了增长加速和运营效率提升。本文基于诺华官方文档，从财务表现、产品业绩、研发管道、资本分配及未来展望等方面，全面分析2025年的业绩亮点。一、财务表现：销售增长与盈利提升全年业绩亮点 2025年，诺华净销售额为545.32亿美元，较2024年的503.17亿美元增长8%（按恒定汇率计算增长8%）。增长主要受益于体积贡献15个百分点，部分抵消了仿制药竞争带来的6个百分点负面影响和定价的1个百分点负面影响。汇率波动对全年销售额无显著影响。 盈利指标方面，营业利润为176.44亿美元，同比增长21%（按恒定汇率计算增长25%）；净收入为139.67亿美元，同比增长17%（按恒定汇率计算增长19%）。每股收益（EPS）为7.21美元，同比增长22%（按恒定汇率计算增长24%）。非国际财务报告准则（非IFRS）指标更清晰地反映了运营绩效：核心营业利润为218.89亿美元，增长12%（按恒定汇率计算增长14%）；核心营业利润率为40.1%，同比提升1.4个百分点；核心每股收益为8.98美元，增长15%（按恒定汇率计算增长17%）。自由现金流为175.96亿美元，增长8%，主要得益于经营活动净现金流入增加。第四季度业绩分析 第四季度销售额为133.36亿美元，同比增长1%（按美元计算），但按恒定汇率计算下降1%。其中，体积贡献18个百分点增长，仿制药竞争带来15个百分点负面影响（包括美国收入扣除调整的3个百分点影响），定价负面影响4个百分点，汇率正面影响2个百分点。营业利润为36.16亿美元，增长2%（按恒定汇率计算增长4%）；净收入为24.04亿美元，同比下降15%（按恒定汇率计算下降14%），主要受所得税增加影响。核心营业利润为49.29亿美元，增长1%；核心每股收益为2.03美元，增长3%。 地区表现方面，美国市场受仿制药冲击（如Entresto和Promacta）明显，但欧洲和亚洲市场在核心产品驱动下表现强劲。现金流方面，第四季度自由现金流为16.55亿美元，同比下降54%，主要因经营活动现金流减少。二、产品业绩：核心品牌驱动增长优先品牌表现 诺华的业绩增长主要由优先品牌推动，这些产品在2025年贡献了显著销售增量。全年来看，明星产品均实现高速增长： Kisgali（乳腺癌治疗）：销售额47.83亿美元，增长57%（恒定汇率）。增长动力来自早期乳腺癌适应症的推广和转移性乳腺癌市场份额提升。 Kesimpta（多发性硬化症治疗）：销售额44.26亿美元，增长36%（恒定汇率），受益于全球需求增加和市场准入改善。 Pluvicto（前列腺癌治疗）：销售额19.94亿美元，增长42%（恒定汇率），在美国税前转移性去势抵抗性前列腺癌（mCRPC）环境中需求强劲。 Scemblix（白血病治疗）：销售额12.85亿美元，增长85%（恒定汇率），凸显了慢性髓性白血病（CML）领域的高未满足需求。 Cosentyx（免疫疾病治疗）：销售额66.68亿美元，增长8%（恒定汇率），在银屑病、关节炎等核心适应症中保持稳定表现。 第四季度，这些产品延续增势：Kisgali增长44%（恒定汇率），Kesimpta增长27%，Pluvicto增长70%，Scemblix增长87%，Cosentyx增长11%。新产品如Fabhalta（PNH治疗）销售额1.55亿美元，增长167%（恒定汇率），显示上市执行力。 其他重点产品 Entresto（心衰治疗）：全年销售额77.48亿美元，下降1%（恒定汇率），受美国仿制药竞争影响。 Leqvio（降脂疗法）：销售额11.98亿美元，增长59%（恒定汇率），通过患者采纳增加稳步扩张。 Zolgensma（基因疗法）：销售额12.32亿美元，增长1%（恒定汇率），在SMA人群中需求稳定。 前20大品牌全年总销售额445.13亿美元，增长12%（恒定汇率），占公司销售主体。产品组合向专科药倾斜，高利润率产品占比提升，支撑了毛利率改善。 三、研发与管道进展：创新里程碑频现监管与临床里程碑 2025年第四季度，诺华在研发管道中取得多项关键进展： 新批准：Itvisma获FDA批准，成为首个用于广泛SMA人群的基因替代疗法；Scemblix获欧盟批准用于新诊断Ph+慢性期CML患者。 监管提交：Remibrutinib向FDA提交用于CINDU常见亚型；Pluvicto提交用于PSMA阳性转移性激素敏感性前列腺癌。 临床试验结果：Pelabresib在III期MANIFEST-2试验96周数据中显示持续疗效；Ianualumab在干燥综合征III期试验中表现积极，获FDA突破性疗法认定。 全年共公布18项III期试验阳性结果，启动21项新III期研究，当前约80项III期试验进行中。重点管道项目覆盖基因治疗（如Itvisma）、放射配体疗法（如Pluvicto）和xRNA平台（如Fabhalta），体现了对新兴技术的投资。战略交易与合作 诺华通过外部合作强化管道，例如拟收购Avidity Biosciences，获得神经科学晚期项目（如DM1和FSHD），交易预计2026年上半年完成。公司还与美国政府达成协议，降低药品价格以支持研发投资，反映了对可持续创新的承诺。四、财务指标深度分析盈利能力与成本控制 核心营业利润率提升至40.1%，主要得益于产品组合优化和运营效率。销售及管理费用全年控制良好，部分被研发投入增加所抵消。研发费用聚焦优先领域，如肿瘤学和免疫学，支撑长期增长。 现金流方面，经营活动净现金流入191.44亿美元，增长9%；自由现金流175.96亿美元，增长8%，为股息和投资提供灵活性。净债务从2024年的161亿美元增至219亿美元，主要因股票回购和并购支出，但资本结构保持稳健（穆迪评级Aa3，标普评级AA-）。股东回报 诺华提议2025年股息为每股3.70瑞士法郎，增长5.7%，标志着连续29年股息增加。全年股票回购89亿美元，减少流通股数，提升每股收益。资本分配平衡了业务投资与股东回报，2025年股东总回报率可观。五、2026年展望：应对挑战与聚焦增长 基于当前预期，诺华对2026年持谨慎乐观态度。预计净销售额低个位数增长，核心营业收入低个位数下降，主要受仿制药冲击（如Entresto专利到期）和定价压力影响。汇率因素可能带来正面贡献（销售额+2-3个百分点）。增长驱动将依赖新药放量（如Fabhalta和Pluvicto新适应症）和管道推进（如Ianualumab提交）。 战略上，公司将继续聚焦四大核心治疗领域，并投资基因治疗等平台。首席执行官Vas Narasimhan强调，诺华有望通过“最大专利到期期”，体现业务韧性。中期指引维持2025-2030年销售复合年增长率5-6%的目标。 相关阅读： 默沙东公布2025年业绩，总营收增长1%，K药大卖317亿美元 礼来2025年成绩单：营收大涨45%至652亿美元，替尔泊肽大卖365亿美元 赛诺菲公布2025年业绩，全年营收增长9.9%至436亿欧元，Dupixent大卖157亿欧元 罗氏公布2025年的业绩，销售额增长7%达615亿瑞郎 强生2025年业绩稳健增长，总营收942亿美元，药品营收604亿美元 立即扫码加入药事纵横交流群

Novartis expects a second-half surge will salvage the year into a low-single-digit sales increase overall. Novartis CEO Vas Narasimhan is doubling down on a growth forecast for 2026, even as the Swiss drugmaker’s fourth-quarter results start to show the impact of the “largest patent expiry” in its history. And while a $4 billion revenue hole awaits, Narasimhan insisted that a wave of newer blockbusters will pull the company back into growth by year-end.The steep patent cliff that Narasimhan was referring to follows the 2025 U.S. entry of generic rivals to heart failure treatment Entresto, blood disorder drug Promacta and cancer therapy Tasigna.Combined, these three meds contributed more than $6 billion to Novartis’ U.S. top line in 2024, before generic impact. And they are expected to create a $4 billion revenue gap in 2026 versus 2025, outgoing CFO Harry Kirsch said during a press call Wednesday.The damage is already visible in the fourth-quarter 2025 numbers, which saw Entresto sales plunge 45% at constant currencies to below $1.3 billion. Even excluding the effect of a revenue deduction adjustment in the U.S., the decline sat at a steep 34%.While the drug held onto its title as Novartis’ biggest product with $7.7 billion in full-year sales, it ranked third in Q4. The impact on the other two brands was even more severe, with Promacta sales plummeting 63% to $226 million and Tasigna falling 58% to $179 million in Q4.The generic hangover will extend into the first half of 2026, during which Novartis expects sales to decline by a low single-digit percentage. That said, Novartis expects a second-half surge to salvage the year for a low-single-digit sales increase overall. To do that, Narasimhan is counting on scaling high-growth assets like cancer drugs Kisqali and Pluvicto, which, according to ODDO BHF analysts, “proved somewhat disappointing” in the fourth quarter.The two drugs posted strong growth numbers, but apparently the gains were not as big as analysts had hoped to see.Thanks to a recent FDA approval in early-stage breast cancer, Kisqali has been on fire, with 44% sales growth at constant currencies in Q4 reaching $1.3 billion. But the number undershot Wall Street’s expectations by 8%, which Narasimhan attributed to a one-time revenue adjustment.Despite the quarterly miss, Narasimhan backed Kisqali’s $10 billion peak annual sales outlook, which he first provided last year.“What’s underpinning that confidence is the very strong volume growth we’re seeing across geographies,” Narsimhan said.In early breast cancer, Kisqali’s new-to-brand share has reached 63% in the U.S. and is “holding steady,” while its share in Germany has reached over 80%, according to the CEO. For Pluvicto, sales of the PSMA-targeted radioligand therapy jumped 70% year over year, reaching $605 million in Q4, which pushed up its full-year sales to just shy of $2 billion.The growth was driven primarily by the U.S. market, where Pluvicto has received a boon from a 2025 FDA approval in first-line metastatic castration-resistant prostate cancer. In that setting, Pluvicto’s U.S. share reached 16% in October, surpassing chemotherapy, according to Narasimhan. And the company expects sales to accelerate with upcoming launches in Japan and China, too. Novartis has also submitted Pluvicto for FDA approval in the hormone-sensitive setting, which adds about 75% of additional patients to the drug’s base.“We have the right foundation for that launch to be, we think, a rapid uptake with two-thirds of eligible hormone-sensitive patients already with existing treaters or providers,” Narasimhan said.While Kisqali and Pluvicto are blockbusters driving major growth today, analysts spent some time during Wednesday’s call on Rhapsido, the oral BTK inhibitor that just came to market last fall as a treatment for chronic spontaneous urticaria.Industry watchers were unnerved following the FDA’s recent rejection of Sanofi’s rival BTK drug tolebrutinib in multiple sclerosis due to liver toxicity concerns. For its part, Novartis expects Rhapsido to read out phase 3 data in relapsing MS in the second half of 2026.Rhapsido does not have liver side effect warnings on its label. But “out of an abundance of caution, given the findings of the other competitors,” the FDA has asked Novartis to implement “limited liver monitoring” in its MS program, Narasimhan explained. Besides tolebrutinib, Roche’s fenebrutinib trial also raised a liver safety signal. “We fully plan to advocate to FDA that we should stick to the current label in the absence of [any liver toxicity signal]," Narasimhan said, noting that in relapsing MS, safety is “absolutely paramount” given the many alternative therapies currently available.The CEO declined to provide an estimate on a potential commercial opportunity, saying that it will be data-driven. He acknowledged that antibodies targeting B-cell pathways, such as Novartis’ own Kesimpta, will continue to be “the dominant class,” given that an oral drug is not expected to have the same level of efficacy. But Narasimhan noted that there’s a large market for patients who’d prefer oral drugs, flagging that 25% of patients in the U.S. and 65% outside of the U.S. are not on injectable B-cell therapy.