礼来(LLY)
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Lilly's Kisunla (donanemab) receives marketing authorization by European Commission for the treatment of early symptomatic Alzheimer's disease
Prnewswire· 2025-09-26 06:39
Accessibility StatementSkip Navigation Approved for earliest symptomatic stages of disease, demonstrating significant slowing of cognitive and functional decline Only therapy with evidence to support completing course of treatment once amyloid plaques are reduced to minimal levels INDIANAPOLIS, Sept. 25, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the European Commission (EC) has granted marketing authorization for Kisunla (donanemab) for the treatment of early symptomatic Al ...
US FDA approves Eli Lilly's therapy for metastatic breast cancer
Reuters· 2025-09-26 02:18
Eli Lilly said on Thursday that the U.S. Food and Drug Administration has approved its therapy for the treatment of metastatic breast cancer in patients whose disease progressed after at least one lin... ...
U.S. FDA approves Inluriyo (imlunestrant) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer
Prnewswire· 2025-09-26 02:01
Accessibility StatementSkip Navigation An estimated 50% of patients with ER+, HER2– metastatic breast cancer will develop an ESR1 mutation during or after exposure to an aromatase inhibitor In the Phase 3 EMBER-3 trial, Inluriyo monotherapy reduced the risk of progression or death by 38% versus endocrine therapy among patients with ESR1-mutated MBC INDIANAPOLIS, Sept. 25, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE:Â LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Inl ...
Medexus Pharmaceuticals Inc. (MDP:CA) Shareholder/Analyst Call Prepared Remarks Transcript
Seeking Alpha· 2025-09-25 23:27
PresentationOperator Hello, and welcome to the Annual Meeting of Shareholders of Medexus Pharmaceuticals Inc. Please note that today's meeting is being recorded. If you participate in today's meeting and disclose personal information, you will be deemed to consent to the recording, transfer and use of the same. If you disclose personal information of another person in today's meeting, you will be deemed to represent and warrant to Medexus and to the host of this webcast and all other relevant parties that y ...
Brookmount Explorations Inc. - Special Call
Seeking Alpha· 2025-09-25 23:27
PresentationOperator I would like to welcome everyone to the call today. We are joined by the CEO, Nils Ollquist. Before we begin, I'll go over the formality of reading the forward-looking statement, and then I'll turn it over to Nils. Except for historical information contained in this presentation, certain of the matters discussed in the communication contribute forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Words such as may, might, will, should, could, an ...
Eli Lilly and Company (LLY) Presents at Bernstein 2nd Annual Global Healthcare Conference Transcript
Seeking Alpha· 2025-09-25 23:27
PresentationCourtney BreenSanford C. Bernstein & Co., LLC., Research Division Fantastic. Hi, everyone. Thank you so much for being with us here today, and I am thrilled to have with me Lucas Montarce, the CFO of Lilly; and Mike Czapar, I'm going to say the last name incorrectly, undoubtedly, the Head of IR for Lilly as well. For those of you who do not know me, my name is Courtney Breen. I am the U.S. large-cap pharma analyst here at Bernstein. And I feel very privileged to share the stage with these 2 here ...
Eli Lilly: Buying The Dip With Confidence
Seeking Alpha· 2025-09-25 22:53
My previous bullish call on Eli Lilly (NYSE: LLY ) hasn’t quite worked out as I’d hoped. Since March, the stock has dropped 10%, which is frustrating. Nevertheless, I believe the short-term price moves aren’t a true reflectionComing from an IT background, I have dived into the U.S. stock market seven years ago by managing portfolio of my family. Starting managing real money has been challenging for the first time, but long hours of mastering fundamental analysis of public companies paid off and now I feel v ...
Here’s What Dragged Eli Lilly and Company (LLY) Down in Q2
Yahoo Finance· 2025-09-25 22:02
PGIM, an investment management company, released its “PGIM Jennison Health Sciences Fund” second-quarter 2025 investor letter. A copy of the letter can be downloaded here. Equities in the second quarter of 2025 experienced significant volatility, as the steep sell-off that initiated at the beginning of the quarter ultimately led to a strong recovery. The S&P 1500 Health Care Index declined 6.9% in the second quarter, underperforming the S&P 500’s 10.9% return. Health care providers & services, life science ...
减重市场下一个爆点明确了
36氪· 2025-09-25 21:04
文章核心观点 - 一个曾被遗忘的靶点Amylin正成为减重药物市场的新焦点,其与GLP-1的协同作用展现出优于单药的疗效和更好的安全性 [1][4][6] - 诺和诺德、礼来、辉瑞、罗氏等多家国际药企正通过收购、合作和复方制剂研发等方式加速布局Amylin领域 [1][8][9] - Amylin的重新崛起为药企提供了差异化竞争的切口,其价值集中在改善GLP-1药物的胃肠道副作用和更好地保留瘦体重 [4][5][7] Amylin靶点的历史与复兴 - Amylin靶点发现于1987年,首个类似物普兰林肽于2005年获批但因需每日注射三次及副作用问题未能成功 [3] - 借助结构生物学与肽类药物技术突破,新一代Amylin药物半衰期显著延长,如礼来Eloralintide达13.9-15.8天,辉瑞MET-233i达19天,解决了频繁给药的痛点 [4] - Amylin的复兴为企业在GLP-1赛道竞争白热化下提供了第二次战略机会 [4][6] 临床数据与疗效优势 - 诺和诺德cagrilintide单药治疗68周实现11.8%的平均体重减轻,其与司美格鲁肽的复方CagriSema减重效果达20.4% [1] - CagriSema组的胃肠道副作用明显低于司美格鲁肽单药,提升了患者依从性 [1][5] - 临床前数据显示礼来Eloralintide可减少高达91%的脂肪,对比GLP-1药物最高40%的瘦体重流失,Amylin能实现更生理性的减重 [7] 药企战略布局与合作 - 诺和诺德布局广泛,除CagriSema外,还推进口服双靶点Amycretin(36周减重22%)和GLP-1/GIP/Amylin三靶点激动剂NN9662 [1][8] - 辉瑞以49亿美元现金加24亿美元里程碑付款收购Metsera,旨在强化其减重管线,特别是将月度给药的MET233i与内部GLP-1管线联合 [1][9] - 罗氏、礼来、艾伯维等也通过合作探索Amylin与GLP-1/GIP等靶点的复方制剂,形成协同作战的共识 [8][9] 未来竞争关键与创新方向 - 行业需避免GLP-1赛道的内卷模式,关键在于多靶点协同研发和剂型创新 [11] - 口服制剂是研发重点,如诺和诺德Amycretin和先为达的VRB103/101组合,能显著提升患者依从性 [12] - 新型递送平台如礼来与Camurus合作的FluidCrystal缓释平台可探索季度给药,博瑞医药利用AI技术优化分子结构,为长效化发展开辟新路径 [12]
Eli Lilly (NYSE:LLY) FY Conference Transcript
2025-09-25 21:02
涉及的行业或公司 * 公司为礼来公司 (Eli Lilly, NYSE: LLY) [1] * 行业为制药行业,特别是专注于心脏代谢健康、肿瘤学、免疫学和神经科学领域 [3][4][7] 核心观点和论据 财务业绩与增长驱动力 * 公司上半年收入增长40%,第二季度增长38%,远超行业水平 [3] * 关键产品(包括tirzepatide,即Mounjaro和Zepbound)在第二季度已代表超过100亿美元收入,增长80% [3] * 增长完全由销量驱动,覆盖美国和国际市场 [4] 制造与供应链战略 * 公司已克服tirzepatide的供应短缺问题,并持续提高产量,上半年达到1.6倍产能目标,下半年目标为1.8倍 [5] * 公司正在全球建设新的生产设施以提升未来产能,包括在北卡罗来纳州、弗吉尼亚州和德克萨斯州的新API(活性药物成分)工厂 [6][14] * 制造投资决策基于未来15-20年的需求预测,重点在于建立供应链的弹性和灵活性,而非单纯追求成本最低 [10][14][16][17] * API成本在公司总成本中占比较低 [18][19] 研发管线与产品进展 * 公司在心脏代谢健康领域拥有广泛的产品组合,口服小分子药物Orforglipron数据读出积极,预计今年将提交肥胖症适应症申请 [7][23][24] * Orforglipron针对对注射剂有顾虑的患者,潜在患者群体庞大(美国1.5亿,国际9亿),目前市场渗透率很低(美国约5%) [25][26] * 公司已为Orforglipron的全球发布建立库存,截至文件记录时价值成本8.5亿美元,且该数字在第三季度财报发布时预计将继续增长 [23][29] * 肿瘤学领域有新产品(如Immunestra口服糖浆)可能明年上市,神经科学领域有Donanemab等阿尔茨海默病疗法在研 [7] * 公司通过业务发展(BD)积极拓展管线,过去签署了30多项交易,主要针对早期资产 [53] 未来战略与投资原则 * 公司采用严格的投资决策流程,平衡短期、中期和长期目标,并利用AI和自动化控制员工人数增长,保持组织敏捷性 [10][11][12] * 战略重点包括扩展治疗领域(如从糖尿病、肥胖症扩展到心脏代谢健康,肿瘤学扩展到血液学等)和探索新的科学方向(如肠促胰岛素药物在精神疾病、炎症等新领域的应用) [54][55][59][60] * 面对未来专利悬崖(如Trulicity专利将于2027年开始到期),公司通过持续创新来驱动增长,并已证明能够平稳度过周期 [52] * 公司在高风险科学领域(如阿尔茨海默病、疼痛管理)的投资基于建立专业知识和科学理论基础,以降低风险 [61] 定价、毛利率与盈利能力展望 * 公司对Orforglipron的定价将遵循“按价值定价”策略,并参考其Lilly Direct皮下注射小瓶的定价模式(例如340美元或499美元)作为价格敏感度的参考 [43][44] * 第二季度毛利率达到85%的创纪录高点,但预计未来将回落至80%出头,原因包括新生产线投产、新产品上市、价格侵蚀以及为增强供应链弹性而进行的投资 [31][68] * 销售及管理费用(SENA)的增长将低于收入增长,主要投入可变成本以推动产品上市;研发费用(R&D)的增长与收入增长并非完全同步,公司将重点关注研发成功率和对未来收入的转化 [69][70] * 长期来看,公司致力于可持续增长,运营利润率可能阶段性达到50%以上,但不会长期维持在该水平,公司将持续再投资以确保2030年及2040年代的增长 [71][72] 创新与颠覆性举措 * Lilly Direct(直接面向患者的平台)和Catalyze 360(与生物技术公司合作的平台)是公司主动创造的颠覆性举措,旨在改善患者体验并抓住外部创新机会 [75][76] * 公司积极应对全球地缘政治等外部颠覆性因素,通过建立全球制造足迹来确保药品供应 [77] 其他重要但可能被忽略的内容 * 公司对Orforglipron的上市路径(如使用优先审评券)持开放态度,目标是尽快将产品推向市场,并准备在全球范围内快速启动,在国际市场的上市间隔将显著短于tirzepatide [34][35] * 公司承认在国际市场发布新产品时,有时仍会低估初始需求,导致短期供应紧张,这被归因于需求预测的挑战而非制造能力问题 [36] * 公司强调应整体看待其产品组合战略(包括即将在第四季度读出数据的Retatrutide),为医生和患者提供多种选择,而非过度关注单个数据点 [27]