本文来自彭博终端，终端用户可运行NSN T5ZVZBGQ7LAO 阅读原文。非终端用户可点击文末 "阅读原文" 预约演示。 本期主题： 礼来业绩领跑、诺和诺德落后：政策不确定性持续困扰制药行业 GLP-1药物第三季度表现分化：礼来亮眼 诺和诺德失色 美国大型药企第三季度收入超预期幅度再次高于欧洲同业，汇率仍是拖累后者收入的主要因 素。礼来凭借肥胖症药物组合的强劲表现，以收入超预期1 0%领跑同业。与之形成鲜明对比 的是，诺和诺德因复合GLP- 1药物竞争加剧持续面临阻力，业绩较预期低约2%，且这一压力 短期内难以缓解。 罗氏因Oc r e v u s、Hemli b r a和Va b y smo三款药物销售疲软，收入未达预期，加剧了市场对其 长期增长前景的担忧，尤其是在其后期产品管线推进缓慢的背景下。此外，葛兰素史克、百 时美施贵宝和阿斯利康在核心增长业务的支持下，实现了低单位数的超预期表现。艾伯维再 次上调对Sk y ri z i和Ri n v o q的预期，这两款药物在第三季度推动了业绩增长，并持续抵消 Humir a销售下滑的影响。 第三季度收入 vs. 市场普遍预期 | | | 诺和诺德EPS未达预期 ...

Key Takeaways Regeneron won EC nod to expand Libtayo as adjuvant therapy for high-risk CSCC after surgery and radiation.FDA approved Eylea HD for RVO with dosing up to every eight weeks after an initial monthly period.The agency also cleared a monthly option of Eylea HD across wAMD, DME, DR and RVO for select patients.Regeneron Pharmaceuticals, Inc. (REGN) announced that the European Commission (EC) has approved label expansion of its PD-1 inhibitor Libtayo (cemiplimab).The EC approved Libtayo as an adjuvan ...

Regeneron Pharmaceuticals Conference Call Summary Company Overview - **Company**: Regeneron Pharmaceuticals (NasdaqGS:REGN) - **Event**: 2025 Conference on November 17, 2025 Key Industry Insights - **Eylea Performance**: - High-dose Eylea (Eylea HD) has shown significant growth with demand increasing by 5% in Q1, 16% in Q2, and 18% in Q3 [4][5][6] - Anticipated growth for Q4 is expected to moderate to high single digits due to competitive market pressures [5] - The competitive landscape includes pricing pressures, with an 8% price impact noted in Q3 [9] - **Market Dynamics**: - Regeneron is focused on differentiating Eylea through real-world efficacy and durability, which is resonating with physicians [4] - The company is addressing reimbursement confidence among physicians to ensure continued prescribing of Eylea HD [5][6] - **Patient Assistance Programs**: - Regeneron has instituted a matching program to support patient assistance organizations, aiming to match contributions up to $200 million, but has seen disappointing participation [12][13] - Concerns exist regarding the impact of patients not receiving supplemental insurance, with an expected 10% impact on patient access [11] Product Development and Regulatory Updates - **Label Enhancements**: - Regeneron is working on label enhancements for Eylea HD, with a PDUFA date later this month for RVO and Q4 dosing [18][19] - The company is optimistic about potential approvals by year-end, contingent on successful inspections of alternative fillers [19][20] - **Pipeline and Future Opportunities**: - Regeneron is exploring opportunities in obesity treatments, including the Hanmi GLP-1 asset, which could be a significant player in the market [31][32] - The company is also investigating Myostatin and its potential applications in obesity and related comorbidities [35][37] Financial Strategy and Shareholder Value - **Capital Deployment**: - Regeneron emphasizes investing in internal capabilities and expanding manufacturing, with a $2 billion investment in New York State [26][27] - The company has a share repurchase program and initiated a dividend program earlier this year [27] - **Cash Management**: - Regeneron is focused on deploying cash effectively to enhance shareholder value, with a cautious approach to accumulating excessive cash reserves [30] Conclusion - Regeneron Pharmaceuticals is navigating a competitive landscape with Eylea while focusing on patient access and assistance programs. The company is actively pursuing label enhancements and exploring new market opportunities in obesity treatments. Financially, Regeneron is committed to strategic investments and maintaining shareholder value through capital deployment and cash management strategies.

Core Insights - Regeneron Pharmaceuticals reported Q3 2025 adjusted EPS of $11.83, exceeding the Zacks Consensus Estimate of $9.44, but down 5% from $12.46 in the previous year due to higher expenses [1][8] - Total revenues increased by 1% year over year to $3.7 billion, driven by higher sales of Eylea HD and increased profits from Dupixent, surpassing the Zacks Consensus Estimate of $3.6 billion [1][8] Revenue Breakdown - Eylea sales in the U.S. fell 41% year over year to $681 million, primarily due to increased competition and market share loss, missing the Zacks Consensus Estimate of $686 million [4] - Eylea HD generated $431 million in the U.S., up 10% year over year, exceeding the Zacks Consensus Estimate of $414 million [6] - Dupixent sales surged 27% year over year to $4.86 billion, contributing significantly to total revenues [10] - Total collaboration revenues reached $2 billion, an increase of 18.6% from the previous year, surpassing the Zacks Consensus Estimate of $1.8 billion [9] Cost and Margin Analysis - Gross margin on net product sales decreased to 86% from 89% due to ongoing investments in manufacturing operations [12] - Adjusted R&D expenses rose 18% year over year to $1.3 billion, reflecting advancements in the company's pipeline [12] - Adjusted SG&A expenses decreased by 12% to $541 million [12] Pipeline and Regulatory Updates - The FDA approved a label expansion for Libtayo as an adjuvant treatment for high-risk adult patients with cutaneous squamous cell carcinoma [16] - A positive opinion was adopted by the EMA for Dupixent for chronic spontaneous urticaria treatment in the EU, with a decision expected soon [14] - Regeneron plans to submit an application for a new pre-filled syringe manufacturing filler for Eylea HD by January 2026 [15] - A phase III study of cemdisiran met its primary and key secondary endpoints, with a regulatory submission planned for Q1 2026 [17] Market Performance - Regeneron's shares have increased following the better-than-expected quarterly results, although they have lost 17.8% year to date compared to the industry's growth of 10.3% [2]

Core Insights - The third-quarter 2025 reporting cycle for the Medical sector is commencing, with major firms expected to release earnings results in the coming weeks, particularly in pharma/biotech and medical devices [1] - Johnson & Johnson has set a positive tone for the earnings season by exceeding estimates and raising its sales expectations for 2025 [1] - Roche has reported solid growth in the first nine months of 2025, driven by high demand for key drugs, leading to an upward revision of its earnings per share growth expectations for 2025 [2] Earnings Trends - As of October 22, 13.3% of Medical sector companies, representing 26.8% of the sector's market capitalization, have reported earnings, with 87.5% exceeding earnings estimates and the same percentage surpassing revenue expectations [3] - Year-over-year earnings increased by 7.4%, while revenues rose by 9.8%. However, third-quarter earnings for the Medical sector are projected to decrease by 4.3%, with sales expected to rise by 8.1% compared to the previous year [3] Company Performance Expectations - Eli Lilly is expected to report strong results driven by demand for GLP-1 drugs and other oncology and immunology products, with a consensus estimate of $16.01 billion in sales and $6.02 per share in earnings [7][8] - Merck is anticipated to see growth from its cancer drug Keytruda, with estimates of $17.06 billion in sales and $2.36 per share in earnings [12] - AbbVie is projected to benefit from sales of Rinvoq, Skyrizi, and newer drugs, with estimates of $15.59 billion in sales and $1.80 per share in earnings [13][14] - Bristol Myers is expected to report revenues influenced by growth portfolio sales, with estimates of $11.83 billion in sales and $1.51 per share in earnings [15][16] - Gilead Sciences is likely to see revenue support from its HIV therapies, with estimates of $7.46 billion in sales and $2.15 per share in earnings, although impacted by changes in Medicare Part D [19][20]

Group 1: Federal Reserve Policy Shift - The Federal Reserve is transitioning from prioritizing inflation control to focusing on growth, with a consensus expectation of interest rate cuts in October and December, indicating a potential continuous rate-cutting cycle [1] - This policy adjustment is driven by reduced inflation pressures and signs of weakness in the job market, rather than economic panic [1] Group 2: Impact on Pharmaceutical and Chemical Industries - The interest rate cuts will lower financing costs and improve global liquidity, significantly benefiting the pharmaceutical sector, especially innovative drug and CXO companies reliant on financing for R&D [3] - The pharmaceutical sector is expected to see increased capital flow towards emerging market assets, supported by recent policy events and conferences [3] - In contrast, the chemical industry may experience a replenishment cycle, stimulating capital expenditures and production investments, but faces challenges from rising raw material costs and weak global demand [3] Group 3: Company Performance Highlights - Sanofi expects high single-digit sales growth and low double-digit earnings per share growth driven by innovation, despite challenges in its vaccine business [4] - Roche reported a 7% year-on-year sales increase to 45.9 billion Swiss francs, primarily driven by its pharmaceutical division, which saw a 9% increase due to high demand for key innovative drugs [5] - Dow Inc. experienced an 8% year-on-year decline in net sales, with all operational segments showing a downturn, although cash flow improved significantly due to working capital optimization [5] Group 4: Trends in the Pharmaceutical and Chemical Sectors - Chinese companies are gaining global competitiveness in the pharmaceutical sector, particularly in the CXO field, which is becoming a crucial base for global pharmaceutical innovation [5] - Traditional sectors like raw material and chemical pharmaceuticals must upgrade technology and collaborate across the supply chain to avoid market share and profit erosion [5] - The future competitiveness of the global market and China's pharmaceutical and chemical industries will increasingly depend on technological innovation and global operational capabilities [6]

Core Insights - Roche Holding AG reported third-quarter sales of CHF 14.9 billion for 2025, reflecting a 6% year-over-year increase at constant exchange rates, driven by strong demand for its drugs [1] - For the first nine months of 2025, total sales reached CHF 45.9 billion, up 7% at constant exchange rates, with the Pharmaceuticals Division growing 9% to CHF 35.5 billion [2][8] - The Diagnostics Division's sales totaled CHF 10.3 billion, up 1%, as demand for pathology solutions and molecular diagnostics offset the impact of healthcare pricing reforms in China [3] Pharmaceuticals Division Performance - Key drugs such as Phesgo, Xolair, Hemlibra, Vabysmo, and Ocrevus generated total sales of CHF 15.8 billion, an increase of CHF 2.4 billion at constant exchange rates compared to the first nine months of 2024 [4] - Ocrevus sales reached CHF 5.2 billion, up 7%, while Hemlibra surged 12% to CHF 3.5 billion, and Vabysmo grew 13% to CHF 3 billion [5] - Xolair sales increased by 34% to CHF 2.2 billion, and Phesgo's sales skyrocketed 54% to CHF 1.8 billion [9] Diagnostics Division Performance - The Diagnostics Division's sales were CHF 10.3 billion, with growth driven by pathology solutions and molecular diagnostics [3] Financial Outlook - Roche expects total sales to grow in the mid-single-digit range at constant exchange rates for 2025, with core earnings per share projected to grow in the high single-digit to low double-digit range [12] Pipeline Developments - The FDA approved label expansions for Gazyva/Gazyvaro and Tecentriq, enhancing Roche's treatment options [13] - Positive results from the phase III evERA study on giredestrant for breast cancer were announced, showing significant reductions in disease progression risk [14] - Roche plans to acquire 89bio, Inc. for $3.5 billion to enhance its portfolio in cardiovascular, renal, and metabolic diseases [15] Competitive Landscape - Roche's drugs, particularly Vabysmo and Hemlibra, have shown strong performance, competing effectively against other market players [17][18]

Core Viewpoint - Roche's shares declined due to disappointing sales of new treatments for eye disease and haemophilia, despite meeting overall revenue expectations for the first nine months of the year [1][4]. Financial Performance - Roche's group revenue increased by 2% on a constant currency basis to 45.9 billion Swiss francs ($57.9 billion) in the first nine months, slightly below analysts' forecasts of 46.2-46.4 billion francs [4]. - The pharmaceutical division's sales for the third quarter were 11.57 billion Swiss francs ($14.59 billion), falling short of analysts' expectations of 11.84 billion francs [5]. Product Performance - Sales of Vabysmo, aimed at treating a common form of blindness, reached 996 million Swiss francs ($1.26 billion) in the third quarter, missing analyst expectations for the second consecutive quarter [5]. - Older drugs like Rituxan and Actemra helped offset shortfalls from newer treatments such as Hemlibra and Vabysmo, indicating a reliance on established products [2]. Market Outlook - Roche raised its adjusted earnings growth forecast to high-single to low-double-digit percentages, supported by cost controls and efforts to mitigate the impact of U.S. tariffs, while maintaining a mid-single-digit sales growth forecast [3]. - CEO Thomas Schinecker emphasized the potential for growth in the obesity drug market, stating that Roche is only "scratching the surface" of this opportunity [4].

Core Viewpoint - Roche has raised its full-year profit guidance due to cost-cutting measures that offset the impact of a weaker dollar on overseas sales [1][2]. Financial Performance - Roche now expects a high-single to low-double-digit percentage increase in adjusted earnings, up from a previous forecast of a high-single-digit increase [1]. - The company confirmed its annual guidance for a mid-single-digit rise in sales [1]. - Group revenues rose 2% in non-adjusted terms to 45.9 billion Swiss francs ($57.9 billion) in the first nine months of the year, which was below analysts' expectations of 46.2-46.4 billion francs [4]. Strategic Initiatives - CEO Thomas Schinecker highlighted that Roche's growth momentum, efforts to mitigate short-term impacts of U.S. tariffs, and cost control measures contributed to the increased guidance [2]. - Roche is investing heavily in obesity drugs to compete with Novo Nordisk and Eli Lilly, indicating that the industry is only beginning to explore the obesity market [3]. Product Performance - Nine-month revenues for the eye drug Vabysmo, which addresses a common form of blindness in the elderly, reached 3.06 billion francs, but this was below expectations [4][5]. - Sales of key growth drivers, including Vabysmo and the haemophilia treatment Hemlibra, missed analysts' forecasts [4].

Core Insights - Roche reported a strong sales growth of 7% at constant exchange rates (CER) for the first nine months of 2025, reaching CHF 45.9 billion, driven by high demand for innovative medicines and diagnostics [4][7][8] - The Pharmaceuticals Division saw a 9% increase in sales (4% in CHF), with key growth drivers including Phesgo, Xolair, Hemlibra, Vabysmo, and Ocrevus [4][8][10] - Roche raised its earnings outlook for 2025, expecting mid single-digit sales growth and core earnings per share to develop in the high single to low double-digit range [6][8] Sales Performance - Group sales for January to September 2025 were CHF 45,862 million, up from CHF 44,984 million in 2024, reflecting a 7% increase at CER and a 2% increase in CHF [4][7] - The Pharmaceuticals Division's sales reached CHF 35,555 million, a 9% increase at CER and a 4% increase in CHF compared to the previous year [4][8] - The Diagnostics Division's sales increased by 1% to CHF 10,307 million, although it experienced a 4% decline in CHF due to healthcare pricing reforms in China [4][14][26] Regional Sales Breakdown - In the United States, sales rose by 8% to CHF 18,798 million, driven by strong performances from Xolair, Phesgo, Ocrevus, and Hemlibra [5][10] - European sales grew by 5% to CHF 6,818 million, supported by demand for Ocrevus and Vabysmo [11] - The International region saw a 13% increase in sales, with China contributing a 9% rise due to the inclusion of Phesgo in the government drug reimbursement list [13] Product Developments and Approvals - Roche's pipeline includes ten potentially transformative medicines in the final phase of development, with expectations for up to 19 new medicines by the end of the decade [2][4] - Recent approvals include Tecentriq for lung cancer and Gazyva/Gazyvaro for severe kidney disease, along with positive recommendations for Lunsumio and advancements in several key drug candidates [4][16][18] - Roche's next-generation sequencing technology is set to launch next year, achieving a record for decoding a whole human genome in under four hours [3] Diagnostics Innovations - Roche received CE marks for several diagnostic tools, including an AI-based risk stratification tool for kidney function decline and a sixth-generation Troponin T test for heart attack diagnosis [24][25] - The Elecsys pTau181 test, a minimally invasive blood test for ruling out Alzheimer's disease, has also received CE mark approval [25]