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Novartis(NVS) - 2025 Q4 - Earnings Call Transcript
2026-02-04 14:02
Financial Data and Key Metrics Changes - Novartis achieved high single-digit sales growth of 8% for the full year 2025, with core operating income increasing by 14% to CHF 21.9 billion, achieving a core margin of 40.1% two years ahead of plan [5][34][36] - In Q4, sales declined by 1% due to gross-to-net impacts and the loss of exclusivity for Entresto, while core operating income increased by 1% [6][34] - Core EPS rose by 17% to $8.98, with free cash flow reaching an all-time high of CHF 17.6 billion, an 8% increase [37][39] Business Line Data and Key Metrics Changes - Kisqali sales grew 57% year-over-year to CHF 4.8 billion, with Q4 growth at 44% [7][8] - Kesimpta achieved 36% growth to $4.4 billion, with a 27% increase in Q4 [10][11] - Pluvicto reached $2 billion in sales, showing 42% constant currency growth, primarily driven by a 75% increase in the US [12][13] - Leqvio reached blockbuster status with 57% growth for the year and 46% in Q4 [14] - Scemblix also achieved blockbuster status with 87% growth in Q4 [15][16] Market Data and Key Metrics Changes - Novartis reported strong performance in key markets, with Kisqali leading in early breast cancer settings in Germany with over 80% NBRX share [8] - Kesimpta is leading in 9 out of 10 major markets outside the US [11] - Pluvicto has secured approvals in Japan and China, with expectations for strong growth in these markets [12] Company Strategy and Development Direction - Novartis aims to grow through the largest patent expiry in its history, focusing on key growth brands and pipeline replacement power [7] - The company is committed to maintaining a strong pipeline with 7 pivotal readouts expected in 2026, which could strengthen midterm growth outlook [31][49] - Novartis plans to continue investing in R&D, with over $10 billion allocated in 2025, and is focused on shareholder returns through dividends and share buybacks [39][40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a 5%-6% sales CAGR from 2025 to 2030, despite anticipated generic impacts [42][48] - The company expects to return to a core margin of over 40% by 2029 [43] - Management highlighted the importance of pipeline assets and their potential to drive higher growth [49] Other Important Information - The company is transitioning leadership with Mukul Mehta set to take over as CFO in mid-March [5][41] - Novartis is focused on global health initiatives, including the development of new malaria treatments [30] Q&A Session Questions and Answers Question: Insights on remibrutinib and FDA conversations - Management noted that remibrutinib has an approved label without liver safety discussions, and they plan to advocate for limited liver monitoring based on FDA feedback [54][56] Question: Commercial opportunities for remibrutinib in MS - Management acknowledged that while B-cell monoclonal antibodies will remain dominant, there is a significant market for oral options, especially for patients preferring non-injectable therapies [61] Question: Risks associated with Pelacarsen's study - Management expressed confidence in the study's design and powering assumptions, indicating that lower event rates may not pose significant risks [63]
Novartis(NVS) - 2025 Q4 - Earnings Call Transcript
2026-02-04 14:00
Financial Data and Key Metrics Changes - Novartis achieved high single-digit growth with an 8% increase in sales and a 14% rise in core operating income for the full year 2025, reaching a core margin of 40.1% [4][35] - For Q4, sales declined by 1%, while core operating income increased by 1%, with core EPS rising 2% to $2.03 [5][38] - Free cash flow reached an all-time high of CHF 17.6 billion, growing 8% year-over-year [35][39] Business Line Data and Key Metrics Changes - Kisqali sales grew 57% year-over-year to CHF 4.8 billion, with Q4 growth at 44% [6][7] - Kesimpta saw a 36% increase to $4.4 billion, with a 27% growth in Q4 [10] - Pluvicto achieved $2 billion in global sales, with a 75% increase in the U.S. [12] - Leqvio reached blockbuster status with 57% growth for the year [14] - Scemblix also reached blockbuster status with 87% growth in Q4 [15] Market Data and Key Metrics Changes - Kisqali's U.S. sales growth was 62%, with over 80% NBRX share in Germany for early breast cancer [7][9] - Kesimpta is leading in NBRX share in 9 out of 10 major markets outside the U.S. [10] - Pluvicto secured approvals in Japan and China, contributing to strong growth outside the U.S. [12] - Scemblix has a 41% NBRX share in the U.S. and 72% in the third-line setting across major markets [17] Company Strategy and Development Direction - Novartis aims to grow through the largest patent expiry in its history, focusing on key growth brands and pipeline replacement [6] - The company plans to continue investing in R&D while managing productivity improvements [43][44] - Novartis is committed to maintaining a 5%-6% sales CAGR from 2025 to 2030 [44][49] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving mid-single-digit sales growth in 2026 despite anticipated challenges from generic entries [43][44] - The company expects to return to a core margin of over 40% by 2029 [44] - Management highlighted the importance of pipeline advancements and upcoming pivotal readouts in 2026 [32][50] Other Important Information - Novartis has completed its CHF 15 billion share buyback program and initiated a new CHF 10 billion program [41] - The proposed dividend for 2025 is CHF 3.70 per share, marking a 6% increase [41][42] Q&A Session Questions and Answers Question: Insights on remibrutinib and FDA conversations - Management noted that remibrutinib has an approved label without liver safety discussions, and they plan to advocate for limited liver monitoring based on FDA feedback [53][54] Question: Commercial opportunities for remibrutinib in MS - Management indicated that the commercial opportunity will depend on data-driven results, with a significant market for oral options in MS [60][61] Question: Thoughts on Pelacarsen's event-based study risks - Management expressed confidence in the study's design and powering assumptions, despite lower than expected event rates [62][63] Question: Launch plans for Rhapsido and Ianalumab in an MFN world - Management acknowledged the importance of adjusting launch strategies for significant assets like Rhapsido and Ianalumab in the ex-U.S. market [73]
医药生物行业周报:诺华siRNA降脂药物在华获批新适应症,关注PCSK9及小核酸赛道-20260204
Shanghai Securities· 2026-02-04 13:39
证 券 研 究 报 告 [Table增_R持at(ing维] 持) | [行Ta业ble_Industry] : | 医药生物 | | --- | --- | | 日期: | 2026年02月04日 shzqdatemark | | [T分ab析le师_Author] : | 张林晚 | | Tel: | 021-53686155 | | E-mail: | zhanglinwan@shzq.com | | SAC 编号: | S0870523010001 | 行 业 周 报 [T相ab关le报_R告e:portInfo] 领域资源整合加速》 《产业化进程加速,脑机接口发展进入快 车道》 《重庆脑机接口获突破性进展,建立癫痫 治疗新范式》 我们认为,我国血脂异常人数近年显著增加,关注代谢领域PCSK9靶点 及小核酸赛道进展。建议关注:恒瑞医药、信达生物、华东医药等。 风险提示 药品/耗材降价风险;行业政策变动风险等;市场竞争加剧风险等。 诺华 siRNA 降脂药物在华获批新适应症,关 注 PCSK9 及小核酸赛道 ——医药生物行业周报(20260126-0130) [Tab主le_要Su观mm点ary] 诺华 ...
Novartis(NVS) - 2025 Q4 - Earnings Call Presentation
2026-02-04 13:00
Content Click below to navigate through the document Company overview 2025 financial review 2026 guidance Conclusions Appendix References Q4 2025 Results Investor presentation February 4, 2025 Novartis Q4 Results | February 4, 2026 1 Content Click below to navigate through the document Company overview 2025 financial review 2026 guidance Conclusions This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can general ...
Novartis(NVS) - 2025 Q4 - Annual Report
2026-02-04 11:45
As filed with the Securities and Exchange Commission on February 4, 2026 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 Form 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSU ...
诺华司库奇尤单抗新适应症在华获批
Jing Ji Guan Cha Wang· 2026-02-04 08:20
此次该药物获批的适应症中轴型脊柱关节炎(axSpA)是一种慢性炎症性疾病。nr-axSpA则属于中轴型脊 柱关节炎的早期阶段。 由于nr-axSpA患者初治多使用非甾体抗炎药(NSAIDs)及物理治疗。然而NSAIDs往往只能起到缓解症状 的作用,难以改变疾病病程,对预防结构损伤的作用不明确,延迟诊断会给患者和社会带来显著的临床 负担和经济负担。因此,早诊早治对改善nr-axSpA患者临床结局并减轻患者负担具有重要意义。 经济观察网2月3日,诺华公司宣布,司库奇尤单抗新适应症获得国家药品监督管理局批准,适用于治疗 对非甾体类抗炎药(NSAID)应答不佳的活动性放射学阴性中轴型脊柱关节炎成人患者。此次新适应症获 批,是该药物继在成人和儿童中重度斑块状银屑病、强直性脊柱炎、银屑病关节炎和化脓性汗腺炎后, 在中国获批的第六个适应症。 PREVENT研究是司库奇尤单抗在nr-axSpA患者中开展的全球III期研究。该研究显示,相较于安慰剂 组,司库奇尤单抗治疗第16周nr-axSpA患者ASAS40应答率高,且改善持续至第52周,安全性良好。研 究次要终点显示出统计学上的显著改善。 ...
仿制药冲击加剧 诺华制药(NVS.US)预警2026年利润将下滑
Zhi Tong Cai Jing· 2026-02-04 07:54
Core Viewpoint - Novartis reported its Q4 2025 earnings, showing a revenue of $13.34 billion, a 1.4% year-over-year increase, but $740 million below expectations. The company anticipates a profit decline this year due to generic competition impacting its blockbuster drugs like Entresto [1][2]. Group 1: Financial Performance - Q4 revenue was $13.34 billion, reflecting a 1.4% year-over-year growth, but fell short of expectations by $740 million [1]. - Non-GAAP earnings per share were $2.03, exceeding expectations by $0.03 [1]. - The company expects core operating profit to decline by a low single-digit percentage when adjusted for constant currency [1]. Group 2: Strategic Initiatives - CEO Vas Narasimhan is focusing on innovative drug strategies, which will be tested this year due to competition from generics affecting Entresto and other established drugs [1]. - Novartis is launching a new pill for autoimmune skin diseases and will soon announce key data for experimental therapies targeting heart disease and multiple sclerosis [1]. - To drive growth, Novartis agreed to acquire Tourmaline Bio for a promising therapy to reduce systemic inflammation and made a significant acquisition of Avidity Biosciences for up to $12 billion [2]. Group 3: Market Position and Future Plans - Novartis has addressed some uncertainties regarding its U.S. business by reaching an agreement with the Trump administration to avoid new industry tariffs in exchange for price reductions [2]. - The company has committed to building seven new manufacturing facilities in the U.S. as part of a $23 billion investment to expand its manufacturing capabilities, primarily focusing on radioligand therapy [2].
转型阵痛期遭遇仿制药围攻 诺华制药预计今年利润将出现下滑
Ge Long Hui A P P· 2026-02-04 06:39
格隆汇2月4日|诺华制药(NVS.US)预计今年利润将出现下滑,原因是受心脏病药物诺欣妥等核心畅销 药面临仿制药竞争的进一步冲击。该公司周三表示,按固定汇率计算,核心营业收入可能出现低个位数 的降幅。销售额预计将增长低个位数。首席执行官Vas Narasimhan专注于创新药物的战略将在今年面临 考验,因为诺欣妥及其他老牌畅销药正饱受仿制药竞争对手带来的压力。目前,诺诺华正在推出一款治 疗自身免疫性皮肤病的新药,并将很快发布针对心脏病和多发性硬化症等实验性疗法的关键数据。诺华 已承诺在美国建设七个新设施,这是其扩大在美制造布局的230亿美元投资计划的一部分。其中很大一 部分将专注于放射配体疗法(RLT)——这是一种利用靶向药物将放射性同位素直接输送到肿瘤的癌症 治疗方法。 ...
Novartis Sales Rise Despite Generic Drug Competition in U.S.
WSJ· 2026-02-04 06:35
Core Insights - The pharma major reported strong results for the year 2025 but has guided towards a decline in core operating profit for the current year [1] Financial Performance - The company achieved robust financial results in 2025, indicating a strong performance in that fiscal year [1] - Despite the strong results in 2025, the company anticipates a decrease in core operating profit for the current year, suggesting potential challenges ahead [1]
Novartis proposes dividend raise to CHF 3.70
Seeking Alpha· 2026-02-04 06:24
Core Viewpoint - Novartis proposes a dividend payment of CHF 3.70 per share for 2025, representing a 5.7% increase from CHF 3.50 per share in the previous year [1] Dividend Proposal - The proposed dividend of CHF 3.70 per share is set to be voted on by shareholders at the Annual General Meeting scheduled for March 6, 2026 [1]