Novartis AG (NYSE:NVS) projects a stronger growth trajectory through 2030, lifting expectations for several key medicines and outlining a pipeline strategy it believes will sustain momentum well into the next decade. • NVS is having a challenging session. See the full story here.The company updated its mid-term outlook ahead of its Meet Novartis Management event in London, emphasizing higher confidence in long-term demand drivers and upcoming drug launches.The drugmaker now anticipates a compound annual sal ...

Novartis (NYSE:NVS) Update / Briefing November 20, 2025 03:00 AM ET Company ParticipantsVasant Narasimhan - CEOSloane Simpson - Head of Investor RelationsSimon Lake - Head of Equity Capital MarketsConference Call ParticipantsSachin James - AnalystMatthew Weston - Pharmaceutical Research AnalystFlorent Cespedes - Senior AnalystSteve Schaller - AnalystNone - AnalystNone - AnalystNone - AnalystSloane SimpsonAll right. Hello, everyone, and welcome to our 2025 Meet Novartis Management Investor event. Thank you, ...

Core Insights - Novartis has updated its mid-term sales guidance for 2025-2030 to a compound annual growth rate (CAGR) of +5-6% at constant currencies, reflecting strong growth momentum from existing products and upcoming launches [2][7] - The company has raised peak sales guidance for key products, now identifying eight de-risked, in-market assets with peak sales potential ranging from USD 3 billion to USD 10 billion [2][8] - Novartis anticipates over 15 potentially submission-enabling readouts in the next two years, supported by a robust pipeline of more than 30 high-value medicines [3][7] Financial Performance - Novartis achieved a core operating income margin of 41.2% in the first nine months of 2025, ahead of its plan, and expects to maintain margins above 40% by 2029 despite some dilution from the acquisition of Avidity Biosciences [4][5] - The company has executed over 30 strategic deals in the past two years, enhancing its pipeline and long-term growth outlook [5] Product and Pipeline Highlights - Key products Kisqali and Scemblix have seen their peak sales forecasts increased, with Kisqali now projected to exceed USD 10 billion and Scemblix expected to reach over USD 4 billion [8] - The pipeline includes over 30 potential high-value medicines, with more than 10 licensed or acquired in the last two years, positioning Novartis for sustainable growth beyond 2030 [3][7]

Core Insights - The lipid-lowering market is projected to reach $35 billion, with some drugs entering the long-term prevention field for cardiovascular event risk reduction (CVRR) [1][2] - Two significant lipid-lowering drugs are expected to report critical Phase III results in 2026, targeting PCSK9 and Lp(a) [1][2] - The development of cardiovascular and cardiac drugs is entering a harvest phase, with a focus on Phase III progress [1] Group 1: Key Developments in Lipid-Lowering Drugs - Novartis' PCSK9 small nucleic acid Leqvio and ASO drug Pelacarsen are under close observation for their Phase III trials, which could expand the market for lipid-lowering therapies [1][2] - Merck's MK-0616, the first oral cyclic peptide PCSK9 to enter Phase III, is expected to influence the long-term trajectory of the PCSK9 market [2] Group 2: Emerging Targets and Innovations - Arrowhead Pharmaceuticals' Plozasiran (ARO-APOC3) is set for FDA approval for treating familial chylomicronemia syndrome (FCS), marking a significant advancement in the siRNA field [3] - Eli Lilly's Lp(a) small molecule inhibitor Muvalaplin has initiated Phase III trials, with plans to enroll 10,450 participants, expected to complete by 2031 [3] Group 3: Direct-to-Consumer (DTC) Transformation - Major pharmaceutical companies like Eli Lilly, AbbVie, and Pfizer are launching online Direct-to-Consumer platforms, breaking traditional barriers in drug sales [4] - This shift aims to attract more self-paying users, particularly in the chronic disease sector, which is anticipated to capture the largest market share in the future [4]

智通财经APP获悉，招商证券国际发布研报称，降血脂市场未来有望达350亿美金，但部分降血脂药物 将进一步进入降低心血管事件风险(CVRR)的长期预防领域。2026年心血管界将有两款重磅降血脂药物 迎来关键三期结果，分别针对两大靶点PCSK9和Lp(a)，密切关注诺华PCSK9小核酸Leqvio的ORION-4 三期和ASO药物Pelacarsen的HORIZON三期试验。此外，默沙东的MK-0616作为全球首个进入三期的口 服环肽PCSK9，未来也将对PCSK9市场的长期走向带来影响。 招商证券国际主要观点如下： 心血管及心脏学新药研发将进入收获期，关注三期进展 以动脉粥样硬化性心血管疾病（ASCVD）为主的心血管疾病（CVD）是我国城乡居民第1位死因，低密 度脂蛋白胆固醇（LDL⁃C）是ASCVD的致病性危险因素。近年来，欧美心血管界将包含载脂蛋白B的 脂蛋白a (Lp(a)) 也提升到独立风险因素之一。Lpa升高是冠心病、缺血性脑卒中、外周血管疾病、冠状 动脉钙化及钙化性主动脉瓣狭窄等的独立危险因素。除此之外，炎症风险也和长期心血管事件相关。 此外，默沙东的MK-0616作为全球首个进入三期的口服环肽PC ...

Core Insights - Novartis will present new data from 33 abstracts related to its Cardiovascular, Renal, and Metabolic (CRM) disease portfolio at the upcoming ASN Kidney Week 2025 and AHA Scientific Sessions 2025, showcasing its commitment to advancing therapies for heart and kidney conditions [1][2] Group 1: Presentation Highlights - The data includes studies on both approved and investigational therapies, emphasizing Novartis's dedication to providing meaningful solutions for patients with various CRM diseases [2] - Key highlights from ASN include analyses of Fabhalta and Vanrafia Phase III studies, real-world treatment patterns for Fabhalta, and C3 glomerulopathy studies that reinforce Fabhalta's long-term safety and efficacy [4][3] - AHA presentations will cover the impact of inclisiran-based treatment strategies on quality of life and muscle-related pain, as well as adherence and goal attainment data supporting inclisiran's addition to lipid-lowering therapy [5][4] Group 2: Product Information - Novartis is focused on redefining the approach to CRM conditions, leveraging a robust portfolio and pipeline to address significant unmet needs in cardiovascular and renal health [7] - The company has a 40-year legacy in cardiovascular care and is expanding its portfolio to target underlying causes of kidney diseases, aiming to transform outcomes and improve lives for patients with CRM diseases [7][9]

Group 1 - The core viewpoint is that small nucleic acid drugs are expected to become the third major category of drugs, following small molecules and antibody drugs, due to their advantages such as targeting traditionally non-druggable targets and long-lasting effects [1] - The breakthrough of GalNAc technology in 2014 established a successful paradigm for liver-targeted delivery, significantly activating the development of the small nucleic acid drug industry [1] - The global small nucleic acid drug industry is currently achieving commercial profitability, breakthrough in indications, advancements in extrahepatic delivery, and dual-target breakthroughs [1] Group 2 - From a commercialization perspective, drugs like Amvuttra and Leqvio show significant potential, with global leader Alnylam expected to achieve profitability this year [2] - The years 2025-2026 are critical for indication breakthroughs, with weight loss indications expected to reach proof of concept (POC) and CNS indications likely to begin exploration [2] - Technological advancements in extrahepatic delivery are emerging, with TRiM and AOC delivery methods showing promise, and Avidity's AOC drug Del-zota expected to be commercially available by 2026 [2] Group 3 - Chinese small nucleic acid drug companies are demonstrating global competitiveness, with an accelerated growth in research pipelines [3] - Companies like Bewang and Ruibo have established business development (BD) transactions with multinational corporations (MNCs), showcasing the global competitiveness of Chinese small nucleic acid drugs [3] - The focus of Chinese small nucleic acid drug pipelines is expanding from cardiovascular diseases and hepatitis B to include weight loss and CNS indications, with potential for first-in-class (FIC) and best-in-class (BIC) drugs [3]

Core Viewpoint - Small nucleic acid drugs are expected to become the third major category of drugs following small molecules and antibody drugs, driven by their ability to target traditionally undruggable targets and their long-lasting effects [1][2]. Group 1: Mechanism and Advantages - The mechanism of small nucleic acid drugs involves three main steps: endocytosis, endosomal escape, and gene silencing [2]. - Key factors for their effectiveness include receptor selection, optimization of delivery systems to enhance endosomal escape efficiency, and chemical modifications to improve stability [2]. - Compared to other drug types, small nucleic acid drugs offer advantages such as a rich target pool, strong specificity, and long-lasting effects [2]. Group 2: Industry Breakthroughs - The global small nucleic acid drug industry is achieving multi-dimensional breakthroughs, with drugs like Amvuttra and Leqvio showing significant potential, and Alnylam expected to achieve profitability this year [3]. - The years 2025-2026 are critical for validating new indications, with weight loss indications anticipated to reach proof of concept (POC) and CNS indications expected to begin exploration [3]. - Technological advancements include breakthroughs in extrahepatic delivery methods, with Avidity's AOC drug Del-zota showing promising efficacy and expected to be commercially available by 2026 [3]. Group 3: China's Competitive Edge - Chinese small nucleic acid drug companies are demonstrating global competitiveness, with an accelerated growth in research pipelines [4]. - Companies like Bosheng and Ruibo have established business development (BD) deals with multinational corporations (MNCs), highlighting China's competitive position [4]. - The focus of Chinese small nucleic acid drug pipelines has expanded from cardiovascular diseases and hepatitis B to include weight loss and CNS indications, with potential for first-in-class (FIC) and best-in-class (BIC) drugs [4].

Financial Performance - Novartis reported a 7% increase in net sales and core operating income for Q3 2025, with a core margin of 39.3% [5][27] - Core EPS rose by 10% to $2.25, and free cash flow totaled $6.2 billion for the quarter [28][27] - For the first nine months, net sales grew by 11%, core operating income by 18%, and core EPS increased by 21% to $6.94 [28][29] Business Line Performance - Key brands showed strong growth: Kisqali grew 68%, Pluvicto 45%, Leqvio 54%, and Scemblix 95% in constant currency [6][10][14][16] - Kisqali's U.S. growth was particularly strong at 91%, with a market-leading position in both metastatic and early breast cancer [7][9] - Pluvicto's growth was driven by new patient starts, with U.S. sales up 53% [11][12] - Leqvio is on track for over $1 billion in sales, with significant growth in both the U.S. and international markets [14][15] - Scemblix is expected to become the most prescribed TKI in the U.S. [16] Market Performance - The U.S. experienced negative growth due to net true-ups related to Medicare Part D redesign, but underlying growth would have been 9% without these adjustments [27][28] - Outside the U.S., Kisqali saw 37% growth in constant currency, and Pluvicto is expanding in Europe, Canada, and Brazil [7][12] - The renal portfolio, particularly IGAN, grew 98% in the U.S., significantly outpacing market growth [20][21] Company Strategy and Industry Competition - Novartis is focused on driving growth through its priority brands and pipeline advancements, despite facing generic erosion from products like Entresto [5][28] - The company is pursuing strategic acquisitions, including Avidity Biosciences, to enhance its growth trajectory [35][36] - Novartis aims to maintain a core margin of around 40% despite expected short-term dilution from new product launches [35][36] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in mid to long-term growth, reaffirming guidance for high single-digit growth in net sales and low teens growth in core operating income for the full year [31][38] - The company anticipates challenges in the first half of 2026 due to generic competition but expects a stronger second half [33][34] - Management highlighted the importance of addressing pricing and reimbursement issues with the administration to support innovation [41][42] Other Important Information - Novartis is preparing for regulatory submissions for several products, including remibrutinib and ianalumab, with expectations for rapid uptake in the market [22][24] - The company is focused on enhancing its R&D capabilities and expanding its manufacturing base in the U.S. [43] Q&A Session Summary Question: Impact of Medicaid and tariffs on the industry - Management indicated that while some companies have reached agreements with the administration, Novartis is in ongoing discussions to find suitable solutions [41][42] Question: CapEx and cash flow modeling - Management clarified that the majority of the $23 billion commitment over five years is for R&D OpEx, with CapEx expected to remain stable at 2.5%-3% of sales [42][43] Question: Market reaction to ATR abstract - Management expressed confidence that detailed data presentation would improve market perception and emphasized the importance of patient benefits over statistical measures [46][47] Question: Pluvicto launch curve and peak sales ambition - Management stated that Pluvicto is on a strong growth trajectory, expecting to reach peak sales of $5 billion with ongoing efforts to tackle commercialization challenges [55][56][58] Question: Remibrutinib ramp-up and European adoption - Management highlighted the focus on payer negotiations and the potential for rapid uptake in the U.S. and Europe, emphasizing the innovative profile of remibrutinib [62][64] Question: Ianalumab study results and secondary endpoints - Management explained the statistical significance achieved in primary endpoints and the importance of patient-relevant outcomes for future discussions with physicians [68][71] Question: Cosentyx market share and new formulation - Management noted that there has been no significant impact from competitor launches and emphasized ongoing efforts to maintain market share in a growing market [74]

Financial Performance - In Q3 2025, net sales grew by 7% year-over-year, and core operating income also increased by 7%, with a core margin of 39.3% [4][26] - Excluding negative adjustments, underlying growth would have been 9% for net sales and 11% for core operating income, driven by priority brands and new launches [26][27] - Core EPS reached $2.25, reflecting a 10% increase, and free cash flow totaled $6.2 billion [27][28] - For the first nine months, net sales grew by 11%, core operating income increased by 18%, and core EPS was up 21% at $6.94 [27][28] Business Line Performance - Kisqali experienced a 68% growth in Q3, with U.S. growth at 91%, making it a leader in both metastatic and early breast cancer markets [5][6] - Pluvicto grew by 45% in constant currency, with U.S. sales up 53%, driven by new patient starts [10][11] - Leqvio sales increased by 54%, on track for over $1 billion in annual sales, with strong performance in both the U.S. and international markets [13][14] - Scemblix grew by 95% in constant currency, becoming the most prescribed TKI by NBRx in the U.S. [15] - Cosentyx had a mixed quarter, with a slight decline in growth due to one-time effects, but remains on track for mid-single-digit growth for the full year [16][17] Market Performance - Kisqali's early breast cancer indication is approved in 56 countries, with significant growth potential outside the U.S. [6][10] - Pluvicto is expected to reach peak sales potential with ongoing approvals in Japan and China [12] - Leqvio shows strong uptake in various international markets, particularly in China and the Middle East [14] - Scemblix is gaining traction in both first-line and second-line settings, with a strong launch momentum in Japan [15] Company Strategy and Industry Competition - The company is focused on driving growth through its priority brands while managing the impact of generic erosion from key products [4][5] - The proposed acquisition of Avidity Biosciences is expected to enhance long-term growth prospects and support mid-single-digit growth over the long term [33][34] - The company is committed to maintaining a strong pipeline and investing in R&D to support future growth [28][29] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in navigating generic headwinds and reaffirmed guidance for high single-digit growth in net sales and low teens growth in core operating income for the full year [29][30] - The company anticipates a challenging first half of 2026 due to the impact of generics but expects to emerge stronger in the second half [31][32] - Management highlighted the importance of addressing pricing and reimbursement challenges in the current regulatory environment [38][61] Other Important Information - The company achieved significant pipeline milestones, including FDA approvals and positive phase 3 results for several key products [4][20] - Management emphasized the importance of cash flow for reinvestment and shareholder returns, with a new $10 billion share buyback program announced [28][29] Q&A Session Summary Question: Industry response to Medicaid and tariffs - Management noted ongoing discussions with the administration and emphasized the need for solutions that address underlying industry issues [38] Question: CapEx over the next five years - Management clarified that the majority of the $23 billion commitment is for R&D OpEx, with no significant increase in CapEx expected [39][40] Question: Market reaction to ATR abstract - Management expressed confidence that detailed data presentation would improve market appreciation of the product [43][44] Question: Impact of Ocrevus subcutaneous launch on Cosentyx - Management indicated no significant impact from Ocrevus, with Cosentyx maintaining its market share [69][70] Question: Pluvicto launch curve and peak sales ambition - Management stated that Pluvicto is on a strong growth trajectory, with expectations of reaching $5 billion in peak sales [52][56]