Key Takeaways Avidity shares jumped 36% after reports that Novartis is interested in acquiring the biotech.FT noted talks are in early stages with no guarantee of a deal and other suitors may emerge.Avidity develops RNA therapies for rare muscular diseases and has major pharma partnerships.Shares of Avidity Biosciences (RNA) have soared 36% in the past month, all thanks to a report issued by the Financial Times (FT), which stated that pharma giant Novartis (NVS) is interested in acquiring the company.Per th ...

诺华重注小核酸肝外递送 2025-08-20 诺华重注小核酸肝外递送 原创 来觅研究院 RimeData 来觅数据 撰稿 张梓英 2025-08-20 导读： 8 月 7 日消息，诺华拟收购目前市值近 60 亿美元的 AOC 领域领军者 Avidity Biosciences （NASDAQ：RNA），旨在通过扩充管线强化罕见病治疗领域的核心布局。据介绍，Avidity Biosciences 是一家致力于提供一类名为抗体寡核苷酸偶联药物（AOC）的新型 RNA 疗法的生物制药公司，目前旗下 共有三条处于临床阶段的 AOC 管线。 小核酸药物（寡核苷酸药物）是一类通过调控基因表达实现疾病治疗的生物大分子药，包括 siRNA、ASO、 miRNA 等，其作用机制主要基于碱基互补配对原则：siRNA 通过 RNA 干扰（RNAi）途径降解靶 mRNA， ASO 通过空间位阻或 RNase H 介导的切割抑制蛋白翻译，miRNA 则通过调控多基因网络影响细胞功 能，这类药物的核心优势在于能靶向传统"不可成药"的致病基因，在基因层面直接调控疾病相关蛋白的 表达，为遗传病、罕见病和慢性病提供了突破性治疗手段。这类药物疗 ...

Core Insights - Novartis will present data from 19 abstracts related to its cardiovascular portfolio at the 2025 European Society of Cardiology Congress in Madrid from August 29 to September 1, 2025 [2][3] - The company aims to showcase innovative treatments that can significantly improve cardiovascular outcomes, focusing on established treatments like Entresto and Leqvio, as well as pipeline assets such as pelacarsen and abelacimab [3][7] Presentation Highlights - Pelacarsen will be featured in multiple presentations, including its effect on reducing the need for lipoprotein apheresis in patients with elevated lipoprotein(a) and cardiovascular disease [4][5] - Leqvio's impact on patient quality of life will be highlighted in two VictORION studies, along with its efficacy as a cholesterol-lowering monotherapy [5][6] - The PARACHUTE-HF study will evaluate the efficacy and safety of Entresto in treating heart failure with reduced ejection fraction due to chronic Chagas disease [5][6] Research Focus - Novartis is dedicated to addressing significant unmet needs in cardiovascular disease through advanced science and technology, particularly in genetically driven risk factors and common heart conditions [7][10] - The company collaborates with patients, healthcare professionals, and organizations globally to enhance cardiovascular care beyond medication [8][10]

Core Viewpoint - President Trump's trade policies, particularly aggressive tariffs on imports, are impacting Wall Street and could increase costs for companies, affecting their margins and stock performance. However, certain healthcare companies like Eli Lilly and Novartis present investment opportunities despite these challenges [1][2]. Eli Lilly - Eli Lilly has committed to investing $50 billion in U.S.-based manufacturing since 2020, with half of this announced in the first quarter [4]. - The company aims to manufacture 100% of medicines for U.S. patients domestically, which will help mitigate the impact of tariffs [5]. - Eli Lilly has shown significant innovation in diabetes and obesity treatments, with new products like Mounjaro and Zepbound generating billions in revenue [5]. - In Q1, Eli Lilly's revenue rose 45% year over year to $12.7 billion, and net income increased by 23% to $2.8 billion [6]. - The company has a strong pipeline, including a promising oral GLP-1 candidate, orforglipron, which could attract patients seeking convenience [7]. - Eli Lilly has increased its dividend payout by 102.7% over the past five years, making it a solid choice for growth and income investors [8]. Novartis - Novartis plans to invest $23 billion over the next five years to enhance its U.S. manufacturing capabilities [9]. - Despite potential short-term impacts from tariffs, Novartis is expected to manage these challenges effectively [10]. - In Q1, Novartis reported a 12% increase in net sales to $13.2 billion and a 22% rise in net income to $4.5 billion [10]. - The company is facing a loss of U.S. patent exclusivity for its heart failure drug Entresto, which generated $2.3 billion in sales in Q1, a 20% increase year over year [11]. - Novartis has prepared for this loss with new medicines like Fabhalta and cancer drugs Scemblix and Pluvicto, which have shown promising sales [11][12]. - The company has increased its dividend for 28 consecutive years, currently offering a forward yield of 3.3%, which is significantly higher than the S&P 500 average [13].

Core Insights - Novartis AG reported better-than-expected Q2 2025 results, with core earnings of $2.42 per share, surpassing the Zacks Consensus Estimate of $2.38 and up from $1.97 a year ago, driven by strong sales growth [1][6] - Revenues reached $14.05 billion, a 12% increase from the previous year, exceeding the Zacks Consensus Estimate of $14.04 billion [1][6] Sales Performance - On a constant currency basis, sales increased by 11%, supported by strong performances from key drugs including Kisqali, Entresto, Kesimpta, Scemblix, Leqvio, and Pluvicto [2][6] - Entresto's sales rose 22% to $2.36 billion, driven by heart failure indications in the U.S. and Europe, and hypertension indications in China and Japan, beating estimates [5][6] - Kisqali's sales surged 64% to $1.2 billion, with strong growth in the U.S. due to recent launches [8] - Kesimpta sales totaled $1.1 billion, up 33%, driven by increased demand [9] - Cosentyx sales increased 6% to $1.6 billion but missed estimates, impacting investor sentiment [7][6] - Pluvicto sales reached $454 million, up 30%, following FDA approval for earlier use, significantly expanding the eligible patient population [12] - Leqvio sales soared 61% to $298 million, driven by steady demand growth [13] Financial Guidance and Strategic Moves - Novartis raised its 2025 core operating income growth outlook to low teens, reflecting strong product and pipeline performance [6][16] - The company initiated a $10 billion share buyback plan, expected to be completed by 2027 [17] - Novartis acquired Regulus Therapeutics Inc. for $0.8 billion, with potential additional payments based on regulatory milestones [21] Management Changes - CFO Harry Kirsch announced his retirement, with Mukul Mehta appointed as the new CFO, effective March 15, 2026 [18]

Core Insights - Novartis reported $14.05 billion in revenue for Q2 2025, a year-over-year increase of 9.2%, with an EPS of $2.42 compared to $1.97 a year ago, exceeding both revenue and EPS consensus estimates [1][3] Revenue Performance - Oncology revenue from Tasigna in the US was $162 million, significantly below the average estimate of $221.75 million, reflecting a year-over-year decline of 29.6% [4] - Net sales of Scemblix in the Rest of the World reached $107 million, surpassing the average estimate of $95.88 million [4] - Oncology revenue from Promacta/Revolade in the US was $227 million, below the average estimate of $285.63 million, marking a year-over-year decline of 19.8% [4] - Immunology revenue from Cosentyx in the US was $921 million, slightly below the average estimate of $993.18 million, but showing a year-over-year increase of 6.1% [4] - Total revenue from Tafinlar + Mekinist in Oncology was $573 million, slightly above the average estimate of $570.15 million, with a year-over-year increase of 9.6% [4] - Kisqali in Oncology generated $1.18 billion, exceeding the average estimate of $1.09 billion, with a substantial year-over-year increase of 64.2% [4] - Total revenue from Cosentyx in Immunology was $1.63 billion, below the average estimate of $1.73 billion, but reflecting a year-over-year increase of 6.8% [4] - Cardiovascular revenue from Entresto totaled $2.36 billion, slightly above the average estimate of $2.34 billion, with a year-over-year increase of 24.2% [4] - Established Brands revenue from Galvus Group was $123 million, below the average estimate of $131 million, reflecting a year-over-year decline of 18% [4] - Established Brands revenue from Exforge Group was $191 million, exceeding the average estimate of $172.31 million, with a year-over-year increase of 7.3% [4] - Kymriah in Established Brands generated $99 million, closely matching the average estimate of $99.32 million, with a year-over-year decline of 12.4% [4] Stock Performance - Novartis shares returned +2.1% over the past month, underperforming the Zacks S&P 500 composite's +4.2% change, with a Zacks Rank 2 (Buy) indicating potential for near-term outperformance [3]

Core Insights - Novartis anticipates Kisqali to become a blockbuster drug, shifting focus from Entresto [1] - Kisqali sales increased by 64% globally in Q2, with 100% growth in the U.S. [1] - The company reported a 56% increase in Kisqali sales in Q1 [2] Industry Trends - Global breast cancer diagnoses and deaths are expected to rise significantly by 2050, with 1 in 20 women projected to be diagnosed [2] - This could lead to 3.2 million new cases and 1.1 million deaths annually by 2050, compared to 2.3 million new cases and 670,000 deaths in 2022 [3] Company Pipeline - Novartis has a strong pipeline with other potential blockbusters like Pluvicto for prostate cancer and Scemblix for chronic myeloid leukemia [3] - The company is focused on driving performance for Kisqali, Pluvicto, and Scemblix, indicating a strategy to replace reliance on older therapies [3]

Financial Data and Key Metrics Changes - Novartis reported an 11% increase in sales in constant currency for Q2 2025, with core operating income rising by 21% [5][43] - Core margin improved to 42.2%, reflecting a 340 basis point increase, and core EPS was $2.42, up 24% [43] - Free cash flow reached $6.3 billion, a 37% increase, while for the first half of the year, sales grew by 13% and core operating income by 24% [43][44] Business Line Data and Key Metrics Changes - Priority brands saw robust growth, with sales up 30% in constant currencies, and excluding Entresto, the portfolio grew by 33% [7] - Kisqali grew by 64% in Q2, achieving TRx leadership in metastatic breast cancer, with a 100% increase in the US [8][9] - Semblix experienced 79% growth, and Lexio grew by 61%, both on track to exceed $1 billion in sales [19][23] Market Data and Key Metrics Changes - In the US, Kisqali's NBRx share reached 61% in early breast cancer, while outside the US, it grew by 25% [9][10] - Cosentyx growth moderated to 6% in Q2, impacted by higher rebates and competitive pressures, particularly in China [25][27] - The company anticipates continued growth in China, albeit at a lower rate than the previous year, due to tightened healthcare spending [69] Company Strategy and Development Direction - Novartis is focused on maintaining strong growth momentum through key launches and pipeline advancements, with an emphasis on innovative therapies [57] - The company announced a new $10 billion share buyback program, reflecting confidence in its long-term growth outlook [45][58] - Ongoing investments in R&D and strategic acquisitions, such as Regulus Therapeutics, are aimed at strengthening the renal pipeline [46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in mid- to long-term growth despite current market challenges, including pricing pressures and competition [57][76] - The company is actively engaging with the US administration regarding drug pricing policies, aiming to balance innovation rewards with patient access [76] - Novartis expects to maintain mid-single-digit growth for Cosentyx, factoring in potential impacts from the Inflation Reduction Act [92] Other Important Information - The company is preparing for the potential entry of generics for Entresto in mid-2025, which is included in financial forecasts [48][49] - Management highlighted the importance of educating policymakers about the US drug pricing system and its effectiveness in promoting innovation [76] Q&A Session Summary Question: Update on Sjogren's Phase III data confidence - Management acknowledged the challenges in demonstrating statistically significant benefits in Sjogren's but remains optimistic based on strong Phase II data [63] Question: Impact of healthcare spending tightening in China - Management noted a slowdown in growth in China but expects to stabilize and maintain high single-digit to low teens growth moving forward [69] Question: Competitive environment for Cosentyx - Management indicated that while there is an initial impact from new competitors, the market typically stabilizes, and they remain confident in Cosentyx's long-term potential [85] Question: Direct negotiation impacts from the IRA - Management confirmed that the IRA has been factored into guidance, estimating that about 30% of Cosentyx sales are exposed to Medicare pricing [91]

Financial Data and Key Metrics Changes - Novartis reported an 11% increase in sales in constant currency for Q2 2025, with core operating income rising by 21% [5][44] - Core margin improved to 42.2%, reflecting a 340 basis point increase, and core EPS was $2.42, up 24% [44] - Free cash flow reached $6.3 billion, a 37% increase, while for the first half of the year, sales grew by 13% and core operating income by 24% [44][45] Business Line Data and Key Metrics Changes - Priority brands saw a 30% increase in sales in constant currencies, with notable growth from Kisqali (up 64%), Kisimta (up 33%), and Pluvicto (up 30%) [7][8][14] - Kisqali achieved TRx leadership in metastatic breast cancer, with a 100% increase in the US for Q2 [8][9] - Lexio grew by 61% in the quarter, with a 47% increase in the US, and Semblix saw a 79% growth [18][22] Market Data and Key Metrics Changes - In the US, Kisqali's NBRx share reached 61% in early breast cancer, while outside the US, it grew by 25% [9] - Cosentyx growth moderated to 6% in Q2, impacted by higher rebates and competitive pressures, particularly in China [24][26] - The company expects continued growth in China, albeit at a lower rate than the previous year, due to tightened healthcare spending [68] Company Strategy and Development Direction - Novartis is focused on maintaining strong growth momentum through key launches and pipeline advancements, including the acquisition of Regulus Therapeutics to enhance its renal portfolio [46][57] - The company has initiated a new $10 billion share buyback program, reflecting confidence in its long-term growth outlook [46][57] - Novartis aims to expand the use of B cell therapies and strengthen its position in the market, particularly for Kisqali and Kisimta [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the mid to long-term growth outlook, despite facing challenges such as potential generic competition for Entresto [57][49] - The company anticipates a strong performance in Q3 based on continued momentum in priority brands, while Q4 may see a step down in growth due to the full impact of potential generics [52][53] - Management acknowledged the ongoing discussions with the administration regarding drug pricing and emphasized the importance of maintaining US leadership in biopharmaceutical innovation [76] Other Important Information - Novartis is advancing its pipeline with significant readouts expected, including for Plavicto and remibrutinib [57] - The company is committed to a balanced capital allocation strategy, including dividends and share buybacks, while continuing to invest in R&D [46][57] Q&A Session Summary Question: Update on Sjogren's Phase III data confidence - Management acknowledged the excitement around Sjogren's but noted the risks involved, emphasizing the importance of robust data from both studies for the filing process [62] Question: Impact of healthcare spending tightening in China on Cosentyx - Management confirmed a notable slowdown in China, with expectations of high single-digit to low teens growth moving forward, while acknowledging the impact on the broader portfolio [68] Question: Competitive environment for Cosentyx - Management indicated that while there is an initial impact from new competitors, the market typically stabilizes, and they remain confident in Cosentyx's long-term growth potential [84] Question: Direct negotiation impacts from IRA on Cosentyx - Management confirmed that the IRA has been factored into guidance, estimating that about 30% of Cosentyx sales are exposed to Medicare pricing, which is manageable [90] Question: Performance expectations for ramibutinib in food allergy - Management expressed confidence in the compelling data for ramibutinib compared to existing treatments and highlighted the potential for a significant commercial launch [104]

Q2 2025 Financial Performance - Novartis delivered double-digit sales growth and core margin expansion in Q2 2025 [134] - Q2 sales reached USD 141 billion, an increase of 11% in constant currencies (cc) compared to Q2 2024 [14] - Core operating income for Q2 2025 was USD 59 billion, a 21% increase in constant currencies (cc) compared to Q2 2024 [14] - Core margin improved to 422%, a 340 basis points increase [14] - Free cash flow for H1 2025 increased by 46% to USD 97 billion [104] FY 2025 Guidance and Capital Allocation - FY 2025 core operating income guidance upgraded to low-teens growth from low double-digit [15] - A new share buyback program of up to USD 10 billion was initiated, to be completed by the end of 2027 [108] - The company assumes Entresto US generic entry in mid-2025 for forecasting purposes [112] Key Products Performance - Kisqali grew by 64% cc in Q2, achieving TRx leadership in mBC [23] - Kesimpta grew by 33% cc in Q2, driven by strong demand growth [31] - Pluvicto grew by 30% cc in Q2, with promising uptake since pre-taxane indication approval in the US [36] - Leqvio grew by 61% cc in Q2, on track for blockbuster status in 2025 [45] - Scemblix grew by 79% cc in Q2, with strong momentum in early lines and global leadership in 3L+ CML [52]