Novartis AG (NYSE:NVS) Investor Event at ASCO Conference Call June 2, 2024 7:00 PM ET Company Participants Parag Mahanti - Investor Relations Shreeram Aradhye - President of Global Drug Development and Chief Medical Officer Jeff Legos - Global Head of Oncology & Hematology Drug Development Reshema Kemps-Polanco - Chief Commercial Officer of U.S. Business Rodney Gillespie - International Therapeutic Area Head, Oncology Novartis Conference Call Participants Emmanuel Papadakis - Deutsche Bank Steve Scala - TD ...

会议主要讨论的核心内容 - Novartis公司在慢性髓性白血病(CML)治疗领域有20多年的历史,先后推出了Glivec和Tasigna等创新药物,大幅提高了CML患者的生存率 [7][8][9] - 尽管取得了巨大进步,但仍有40%的CML患者需要在5年内更换治疗方案,一半患者无法达到深度分子学反应,四分之一患者可能实现治疗停药 [10][11][12] - 公司开发了新药Scemblix,旨在提高疗效并改善耐受性,从而使更多患者能够长期坚持治疗并实现治疗停药的目标 [13][14][16] - Scemblix在III期ASC4FIRST临床试验中显示出优于现有标准治疗的疗效和安全性,包括在48周时显著提高主要分子学反应率、缩短达到主要分子学反应的时间,以及降低不良事件导致停药的风险 [28][29][30][31][32][33][34][35][36][37][38][39][40] - 基于这些积极结果,Scemblix已获得FDA突破性疗法认定,公司正在加快审批进程,预计2024年下半年至2025年陆续在全球提交上市申请 [41][42][43] 问答环节重要的提问和回答 问题1 **Emmanuel Papadakis 提问** 询问Scemblix在二代TKI子组(如Tasigna)与整体二代TKI组的数据差异 [74] **Jeff Legos 回答** 目前尚未对Scemblix在不同二代TKI子组的数据进行细分分析,但总体来看,Scemblix相比所有调查者选择的二代TKI均显示出明显的疗效优势 [75] 问题2 **Seamus Fernandez 提问** 询问随着二代TKI仿制药的上市,以及一些医生更倾向于使用低剂量二代TKI维持疗效的做法,Scemblix在一线治疗中的定位和挑战 [116][117][118] **Reshema Kemps-Polanco 回答** 目前美国一线CML患者中,已有60%不是使用伊马替尼,而是直接使用二代TKI,这为Scemblix在一线治疗中提供了较大的机会。对于仍然使用伊马替尼的医生,Scemblix的优异疗效和良好耐受性也有望说服他们转而使用Scemblix [119][120][121] 问题3 **Peter Welford 提问** 询问Scemblix在美国和海外市场的准入情况,包括质量生活数据、长期随访数据的重要性,以及2025年合同谈判的时间节点 [122][123][124][125][126][127][128][129][130][131][132][133] **Jeff Legos 和 Reshema Kemps-Polanco 回答** 公司将在96周数据分析时发布Scemblix的生活质量数据,这对于说服支付方很重要。同时,医生反馈患者使用Scemblix后感受良好也是一个重要的代理指标。对于2025年的准入谈判,公司正在积极准备,包括确保Scemblix纳入NCCN指南等,预计不会出现太大障碍 [125][126][127][128][129][130][131][132][133]

Patients treated with remibrutinib experienced improvements in weekly urticaria activity scores (UAS7) observed as early as Week 1 and sustained to 1 year (Week 52)1 Remibrutinib, an oral Bruton's tyrosine kinase inhibitor, demonstrated a favorable and consistent safety profile up to 1 year, including balanced liver function tests versus placebo1 Novartis intends to submit remibrutinib for approval in chronic spontaneous urticaria (CSU) to global health authorities starting in H2 2024, and continues to inve ...

Novartis (NVS) announced results from the six-month, double-blind trial period of the late-stage APPEAR-C3G study of Fabhalta.Fabhalta, an oral Factor B inhibitor of the alternative complement pathway, is being investigated in adult patients with C3 glomerulopathy (C3G).APPEAR-C3G is a phase III multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of twice-daily oral Fabhalta (200 mg) in C3G patients. The study comprises a six-month double-blind ...

文章核心观点 - 公司在第一季度业绩表现良好,净销售额和核心每股收益均实现增长 [6][9] - 公司有信心提高全年业绩指引,预计净销售额和核心营业利润将实现高个位数至低双位数的增长 [11] - 公司拥有丰富的产品管线,未来几年将向监管机构提交20多个适应症的申请,为公司未来增长提供动力 [12][13] - 公司财务状况良好,净债务水平可控,维持AA-的信用评级 [15][16][17] 公司表现总结 - 公司第一季度净销售额同比下降8.7%,但剔除剥离业务影响后,持续经营业务净销售额同比增长9.5%,按不变汇率计算增长11% [6][7] - 公司20大产品净销售额同比增长16%,其中13个产品实现双位数增长,如Entresto、Cosentyx、Kesimpta和Kisqali等 [8][9] - 公司核心每股收益同比增长16.9%,超出分析师预期 [9] - 公司通过成本管控,非公认会计准则净利润率扩大120个基点至31.1% [10] 未来展望 - 公司有100多个在研项目,未来几年将向监管机构提交20多个适应症的申请,为公司未来增长提供动力 [12][13] - 分析师预测公司2024年核心每股收益将增长12.4%,2025年增长8.4%,2026年增长2.7% [14] - 公司目前估值处于折价水平,与10年平均市盈率相比有18%的上涨空间 [18][19][21] 股息分析 - 公司目前股息收益率为3.7%,高于医疗行业1.5%的中位数 [23] - 公司过去5年股息年复合增长率为6.9%,略高于行业中位数6.6% [24] - 公司连续27年增加股息,未来增长可持续性强 [25][26] 风险因素 - 公司面临行业竞争压力,需持续推出新产品以维持增长 [28] - 高利润率可能引发公众和监管关注,未来可能面临更严格的价格管控 [30] - 公司可能遭受网络攻击,导致核心数据泄露,影响竞争优势 [30]

In the ALIGN study, atrasentan, in addition to supportive care with a renin-angiotensin system (RAS) inhibitor, demonstrated a statistically significant 36.1% proteinuria (protein in urine) reduction vs. placebo + supportive care at 36 weeks1Endothelin A (ETA) receptor activation contributes to elevated proteinuria in IgAN2-5; atrasentan is a potent, selective ETA receptor antagonist with potential to reduce persistent proteinuria and preserve kidney function for a broad patient population1 IgAN is a hetero ...

Secondary endpoint data for estimated glomerular filtration rate (eGFR) showed numerical improvement over 6 months vs. placebo1; additional 6-month open-label data to be presented at a future medical meeting2,3Fabhalta showed a favorable safety profile with no new safety signals1C3G, an ultra-rare kidney disease caused by alternative complement pathway overactivation, progresses to kidney failure in ∼50% of patients within 10 years4-7; currently there are no treatments approved for C3G7-9Fabhalta, an oral F ...

New York, USA, May 16, 2024 (GLOBE NEWSWIRE) -- Motor Neuron Disease Clinical Trial Pipeline Appears Robust With 120+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight The market growth rate is significantly impacted by the rising prevalence of motor neuron disease and the increasing geriatric population. Additionally, the burgeoning demand for advanced and efficient treatment options, coupled with a rise in healthcare spending, expanding government funding, and concerted init ...

The dividend is just one reason to buy these stocks.There are many reasons to invest in excellent dividend stocks. Such investments are often worth the trouble regardless of whether you're investing for the dividend, or for making capital gains from the robust business (always a laudable goal). But here's the common thread that runs through outstanding dividend stocks: Companies that grow their dividend payouts over extended periods time all have solid fundamentals.The obvious corollary is, not every divide ...

A double beat on the latest quarterly results and raised guidance made investors happy.Scooting past analyst estimates for its latest quarter gave Novartis (NVS 2.27%) a lift on Tuesday. Investors like what they heard about the global healthcare company's inaugural earnings release for 2024, and rewarded Novartis with a more than 2% lift in its stock price today. The shares did better than the S&P 500 index, which had a relatively good trading session with a 1.2% gain.Double beats in the first quarterIn its ...