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2021-11-04
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Moderna stock plunged 9% after reporting quarterly results<blockquote>Moderna 公布季度业绩后股价暴跌 9%</blockquote>
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FactSet consensus $6.200 bln;</li> </ul> <ul> <li>Moderna Q3 EPS $7.70 vs loss 59 cents a share a year ago; FactSet consensus $9.09;</li> </ul> <img src=\"https://static.tigerbbs.com/2e0e9dd869aaa4060fdee9429041a910\" tg-width=\"847\" tg-height=\"621\" referrerpolicy=\"no-referrer\"></p><p><blockquote><ul><li>Moderna 第三季度收入为 49.69 亿美元，而去年同期为 1.57 亿美元；FactSet 共识 62 亿美元；</li></ul><ul><li>Moderna 第三季度每股收益 7.70 美元，而一年前每股亏损 59 美分；FactSet 共识 9.09 美元；</li></ul></blockquote></p><p> Moderna, Inc. today reported financial results and provided business updates for the third quarter of fiscal year 2021.</p><p><blockquote>Moderna，Inc.今天公布了2021财年第三季度的财务业绩并提供了业务更新。</blockquote></p><p> <i>Q3 total revenue of$5.0 billion, net income of$3.3 billionand diluted EPS of$7.70</i></p><p><blockquote><i>第三季度总收入 50 亿美元，净利润 33 亿美元，摊薄每股收益 7.70 美元</i></blockquote></p><p> <i>U.S.FDA granted Priority Review to the Biologics License Application for Moderna’s COVID-19 vaccine</i></p><p><blockquote><i>美国食品药品监督管理局批准优先审查 Moderna 的 COVID-19 疫苗生物制剂许可申请</i></blockquote></p><p> <i>Interim data from Phase 2/3 KidCOVE study of mRNA-1273 in children ages 6 to under 12 years shows vaccine efficacy of 100% two weeks after first dose of mRNA-1273 at 50 µg dose level</i></p><p><blockquote><i>mRNA-1273在6至12岁以下儿童中的2/3期KidCOVE研究的中期数据显示，在50 µg剂量水平下首次接种mRNA-1273两周后，疫苗效力为100%</i></blockquote></p><p> <i>First participants dosed in Phase 3 study of cytomegalovirus (CMV) vaccine candidate (mRNA-1647)</i></p><p><blockquote><i>巨细胞病毒 (CMV) 候选疫苗 (mRNA-1647) 3 期研究的首批参与者接种疫苗</i></blockquote></p><p> <i>Introducing inhaled pulmonary therapeutics modality:Vertex andModernacystic fibrosis mRNA therapeutic (VXc-522) IND-enabling first-in-human studies ongoing</i></p><p><blockquote><i>介绍吸入性肺治疗模式：Vertex 和 Moderna 囊性纤维化 mRNA 治疗 (VXc-522) IND 支持的首个人体研究正在进行中</i></blockquote></p><p> <i>Company continues to scale with 37 programs in development, including 21 in ongoing clinical studies</i></p><p><blockquote><i>公司继续扩大规模，有 37 个项目正在开发中，其中 21 个项目正在进行临床研究</i></blockquote></p><p> <b>Updates and recent progress include:</b></p><p><blockquote><b>更新和最新进展包括：</b></blockquote></p><p> <i>COVID-19 Vaccine Development</i></p><p><blockquote><i>COVID-19疫苗开发</i></blockquote></p><p> <ul> <li>Moderna COVID-19 Vaccine (SpikevaxTM): Received Emergency Use Authorization (EUA) from theU.S. Food and Drug Administration(U.S.FDA), and approvals by theEuropean CommissionandSwissmedicfor a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level</li> <li>U.S.FDA granted Priority Review to the Biologics License Application (BLA) for the Moderna COVID-19 vaccine</li> <li>New data from Phase 2/3 KidCOVE study of mRNA-1273 in children ages 6 to under 12 years shows vaccine efficacy of 100% two weeks after first dose of mRNA-1273 at 50 µg dose level, using the Phase 3 COVE study primary case definition for COVID-19</li> <li>The Phase 1 study of next-generation vaccine candidate against COVID-19 (mRNA-1283) is fully enrolled;Modernaexpects to begin Phase 2 study of mRNA-1283 soon; mRNA-1283 is being developed as a potential refrigerator-stable mRNA vaccine</li> </ul> <i>Respiratory Vaccines</i></p><p><blockquote><ul><li>Moderna新冠肺炎疫苗（SpikevaxTM）：获得美国紧急使用授权（EUA）。美国食品药品监督管理局 (U.S.FDA)、欧盟委员会和瑞士医疗公司批准 50 µg 剂量水平的 Moderna COVID-19 疫苗加强剂量</li><li>美国FDA授予Moderna COVID-19疫苗生物制品许可申请（BLA）优先审查</li><li>在6至12岁以下儿童中进行的mRNA-1273的2/3期KidCOVE研究的新数据显示，使用COVID-19的3期COVE研究主要病例定义，在50 µg剂量水平下首次接种mRNA-1273两周后，疫苗效力为100%</li><li>针对新冠肺炎（mRNA-1283）的下一代候选疫苗1期研究已全部入组；Moderna预计很快开始mRNA-1283的2期研究；mRNA-1283正在被开发为一种潜在的冰箱稳定mRNA疫苗</li></ul><i>呼吸道疫苗</i></blockquote></p><p> <ul> <li>Phase 1 portion of the Phase 1/2 study of quadrivalent seasonal flu vaccine candidate (mRNA-1010) fully enrolled, preparations for Phase 2 portion of the study are ongoing</li> <li>Pivotal Phase 2/3 study of respiratory syncytial virus (RSV) vaccine candidate (mRNA-1345) in older adults expected to begin in 2021; study expected to enroll approximately 34,000 participants, subject to agreement with regulatory authorities</li> <li>New combination respiratory vaccines: Moderna COVID-19 vaccine + flu vaccine candidate (mRNA-1073) and pediatric RSV + hMPV vaccine candidate (mRNA-1365)</li> </ul> <i>Latent Vaccines</i></p><p><blockquote><ul><li>四价季节性流感疫苗候选疫苗（mRNA-1010）的1/2期研究的1期部分已全部入组，研究的2期部分准备工作正在进行中</li><li>呼吸道合胞病毒（RSV）候选疫苗（mRNA-1345）在老年人中的关键2/3期研究预计将于2021年开始；研究预计将招募约 34,000 名参与者，但须与监管机构达成协议</li><li>新型呼吸道联合疫苗：Moderna COVID-19疫苗+流感疫苗候选物（mRNA-1073）和儿科RSV+hMPV疫苗候选物（mRNA-1365）</li></ul><i>潜伏疫苗</i></blockquote></p><p> <ul> <li>First participants dosed in Phase 3 study of cytomegalovirus (CMV) vaccine candidate (mRNA-1647)</li> <li>Phase 1 study of EBV vaccine candidate (mRNA-1189)expected to start soon</li> <li>New EBV therapeutic vaccine candidate (mRNA-1195)</li> </ul> <i>Therapeutics</i></p><p><blockquote><ul><li>巨细胞病毒 (CMV) 候选疫苗 (mRNA-1647) 3 期研究的首批参与者接种疫苗</li><li>EBV候选疫苗（mRNA-1189）1期研究有望很快启动</li><li>新型EBV治疗性候选疫苗（mRNA-1195）</li></ul><i>治疗</i></blockquote></p><p> <ul> <li>Phase 2 randomized, placebo-controlled study of personalized cancer vaccine (PCV) (mRNA-4157) in combination with Merck’s pembrolizumab (KEYTRUDA®), compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma is fully enrolled; data readout expected in the fourth quarter of 2022</li> <li>Enrollment of the first cohort in Propionic Acidemia candidate (mRNA-3927) Phase 1/2Paramountstudy is complete</li> <li>First patient dosed in Phase 1 study of Methylmalonic Acidemia (MMA) candidate (mRNA-3705)</li> <li>Investigational New Drug application (IND) open and Orphan Drug Designation granted byU.S.FDA for GSD1a program (mRNA-3745)</li> <li>Providing investigational mRNA Crigler-Najjar Syndrome Type 1 (CN-1) therapy (mRNA-3351) toInstitute for Life Changing Medicines(ILCM) free of charge; CN-1 is an ultra-rare disease</li> <li>Introducing inhaled pulmonary therapeutics modality; IND-enabling first-in-human studies of Vertex andModernamRNA cystic fibrosis (CF) therapeutic (VXc-522) are ongoing in new pulmonary modality</li> </ul> Moderna continues to scale, now with 37 programs in development across 34 development candidates1, including 21 in ongoing clinical studies. The Company’s updated pipeline can be found atwww.modernatx.com/pipeline.Modernaand collaborators have published nearly 100 peer reviewed manuscripts.</p><p><blockquote><ul><li>个性化癌症疫苗（PCV）（mRNA-4157）联合默沙东帕博利珠单抗（KEYTRUDA）的2期随机、安慰剂对照研究®)，与单用派姆单抗相比，用于辅助治疗高危切除黑色素瘤完全入组；预计2022年第四季度数据读数</li><li>丙酸血症候选药物（mRNA-3927）1/2期Paramount研究完成首个队列入组</li><li>甲基丙二酸血症（MMA）候选药物（mRNA-3705）的1期研究中首例患者给药</li><li>GSD1a 计划 (mRNA-3745) 获得 byU.S.FDA 开放和孤儿药资格的研究性新药申请 (IND)</li><li>向改变生活药物研究所(ILCM)免费提供研究性mRNA Crigler-Najjar综合征1型(CN-1)疗法(mRNA-3351)；CN-1是一种极其罕见的疾病</li><li>引入吸入肺治疗模式；Vertex 和 ModernaMRNA 囊性纤维化 (CF) 治疗剂 (VXc-522) 的 IND 首例人体研究正在新的肺部模式中进行</li></ul>Moderna 继续扩大规模，目前有 37 个项目正在开发中，涉及 34 个开发候选项目1，其中 21 个项目正在进行临床研究。该公司更新后的管道可在 www.modernatx.com/pipeline.moderna 上找到，合作者已经发表了近 100 篇同行评审稿件。</blockquote></p><p> <b>2021 Updated Financial Framework</b></p><p><blockquote><b>2021年更新的财务框架</b></blockquote></p><p></p><p> <ul> <li><b>For Expected Delivery in Fiscal Year (FY) 2021:</b>Expected to realize product sales for FY 2021 between$15 billionand$18 billion.</li> <li></li> <li><b>Vaccine Dose Deliveries for FY 2021:</b>The Company expects deliveries of its COVID-19 vaccine in FY 2021 to be between 700 million and 800 million doses at the 100 µg dose level. Key variables impacting output include longer delivery lead times for international shipments and exports that may shift deliveries to early 2022, temporary impact from expansion of fill/finish capacity and ramp up of product release to market.</li> <li><b>Cost of Sales:</b>Cost of sales as percentage of product sales are expected to be between 16-17% for FY 2021.</li> <li><b>2021 Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses:</b>Continue to expect quarter over quarter cost increases in R&D and SG&A expenses during 2021 as commercial and research and development activities and expenses ramp up.</li> <li><b>Tax Rate:</b>The Company now expects the effective tax rate for 2021 to be in the high single digit range as a result of the forecasted global sales mix and utilization of the accumulated net operating loss carry-forward of$2.3 billion.</li> <li><b>Capital Expenditures:</b>Expect approximately$0.4 billionof capital investments for 2021.</li> <li><b>Share Repurchase Program:</b>The Board of Directors has authorized a share repurchase program of up to$1 billionover a two-year period to return excess capital to shareholders. No shares were repurchased through the end of the third quarter.</li> </ul> <b>2022 Revenue Drivers</b></p><p><blockquote><ul><li><b>对于2021财年（FY）的预期交付：</b>预计 2021 财年产品销售额将在 150 亿至 180 亿美元之间。</li><li></li><li><b>2021财年的疫苗剂量交付：</b>该公司预计 2021 财年 100 µg 剂量水平的 COVID-19 疫苗交付量将在 7 亿至 8 亿剂之间。影响产量的关键变量包括国际运输和出口的交付周期延长，这可能会将交付时间推迟到 2022 年初，灌装/精加工能力扩张的暂时影响以及产品投放市场的增加。</li><li><b>销售成本：</b>2021财年，销售成本占产品销售的百分比预计在16-17%之间。</li><li><b>2021 年研发 (R&D) 和销售、一般和行政 (SG&A) 费用：</b>随着商业和研发活动及费用的增加，预计 2021 年研发和 SG&A 费用将逐季增加。</li><li><b>税率：</b>由于预测的全球销售组合和累计净运营亏损结转 23 亿美元，该公司目前预计 2021 年的有效税率将在高个位数范围内。</li><li><b>资本开支：</b>预计 2021 年资本投资约为 4 亿美元。</li><li><b>股份购回计划：</b>董事会已授权在两年内实施高达 10 亿美元的股票回购计划，以将多余资本返还给股东。截至第三季度末，没有股票被回购。</li></ul><b>2022 年收入驱动因素</b></blockquote></p><p> They expect several dynamics will drive 2022 revenues:</p><p><blockquote>他们预计几个动态将推动 2022 年收入：</blockquote></p><p> <ul> <li><b>APAs Signed:</b>The Company has signed approximately$17 billionof advance purchase agreements (APAs) for delivery in 2022.</li> <li><b>APAs with Options:</b>The Company anticipates the exercise of options under 2022 APAs of up to$3 billion.</li> <li><b>U.S.Fall 2022 Booster Market:</b>Subject to receipt of a BLA or sBLA for boosters prior to the fall booster season, the Company anticipates commercial booster market sales could be up to$2 billion.</li> </ul> Based on these three revenue drivers, the Company believes 2022 sales could be in the range of$17 billionto$22 billion. The Company continues to have discussions for 2022 APAs with governments and international organizations, including COVAX, thePan American Health Organization(PAHO) and theAfrican Union.</p><p><blockquote><ul><li><b>APA签署：</b>该公司已签署约 170 亿美元的预购协议 (APA)，将于 2022 年交付。</li><li><b>具有选项的APA：</b>该公司预计 2022 年 APA 下的期权行使量高达 30 亿美元。</li><li><b>美国2022 年秋季助推器市场：</b>如果在秋季助推器季节之前收到助推器的 BLA 或 sBLA，该公司预计商业助推器市场销售额可能高达 20 亿美元。</li></ul>根据这三个收入驱动因素，该公司认为 2022 年销售额可能在 170 亿至 220 亿美元之间。该公司继续与各国政府和国际组织讨论 2022 年 APA，包括 COVAX、泛美卫生组织 (PAHO) 和非洲联盟。</blockquote></p><p></p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Moderna stock plunged 9% after reporting quarterly results<blockquote>Moderna 公布季度业绩后股价暴跌 9%</blockquote></title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; 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}\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nModerna stock plunged 9% after reporting quarterly results<blockquote>Moderna 公布季度业绩后股价暴跌 9%</blockquote>\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time smaller\">2021-11-04 19:05</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<p>Moderna stock plunged 9% after it cut its Covid-19 vaccine sales forecast for the year and missed earnings and revenue expectations for the third quarter.</p><p><blockquote>Moderna 下调今年 Covid-19 疫苗销售预测并未达到第三季度盈利和收入预期，股价暴跌 9%。</blockquote></p><p> <ul> <li>Moderna Q3 revenue $4.969 bln vs. $157 mln a year ago; FactSet consensus $6.200 bln;</li> </ul> <ul> <li>Moderna Q3 EPS $7.70 vs loss 59 cents a share a year ago; FactSet consensus $9.09;</li> </ul> <img src=\"https://static.tigerbbs.com/2e0e9dd869aaa4060fdee9429041a910\" tg-width=\"847\" tg-height=\"621\" referrerpolicy=\"no-referrer\"></p><p><blockquote><ul><li>Moderna 第三季度收入为 49.69 亿美元，而去年同期为 1.57 亿美元；FactSet 共识 62 亿美元；</li></ul><ul><li>Moderna 第三季度每股收益 7.70 美元，而一年前每股亏损 59 美分；FactSet 共识 9.09 美元；</li></ul></blockquote></p><p> Moderna, Inc. today reported financial results and provided business updates for the third quarter of fiscal year 2021.</p><p><blockquote>Moderna，Inc.今天公布了2021财年第三季度的财务业绩并提供了业务更新。</blockquote></p><p> <i>Q3 total revenue of$5.0 billion, net income of$3.3 billionand diluted EPS of$7.70</i></p><p><blockquote><i>第三季度总收入 50 亿美元，净利润 33 亿美元，摊薄每股收益 7.70 美元</i></blockquote></p><p> <i>U.S.FDA granted Priority Review to the Biologics License Application for Moderna’s COVID-19 vaccine</i></p><p><blockquote><i>美国食品药品监督管理局批准优先审查 Moderna 的 COVID-19 疫苗生物制剂许可申请</i></blockquote></p><p> <i>Interim data from Phase 2/3 KidCOVE study of mRNA-1273 in children ages 6 to under 12 years shows vaccine efficacy of 100% two weeks after first dose of mRNA-1273 at 50 µg dose level</i></p><p><blockquote><i>mRNA-1273在6至12岁以下儿童中的2/3期KidCOVE研究的中期数据显示，在50 µg剂量水平下首次接种mRNA-1273两周后，疫苗效力为100%</i></blockquote></p><p> <i>First participants dosed in Phase 3 study of cytomegalovirus (CMV) vaccine candidate (mRNA-1647)</i></p><p><blockquote><i>巨细胞病毒 (CMV) 候选疫苗 (mRNA-1647) 3 期研究的首批参与者接种疫苗</i></blockquote></p><p> <i>Introducing inhaled pulmonary therapeutics modality:Vertex andModernacystic fibrosis mRNA therapeutic (VXc-522) IND-enabling first-in-human studies ongoing</i></p><p><blockquote><i>介绍吸入性肺治疗模式：Vertex 和 Moderna 囊性纤维化 mRNA 治疗 (VXc-522) IND 支持的首个人体研究正在进行中</i></blockquote></p><p> <i>Company continues to scale with 37 programs in development, including 21 in ongoing clinical studies</i></p><p><blockquote><i>公司继续扩大规模，有 37 个项目正在开发中，其中 21 个项目正在进行临床研究</i></blockquote></p><p> <b>Updates and recent progress include:</b></p><p><blockquote><b>更新和最新进展包括：</b></blockquote></p><p> <i>COVID-19 Vaccine Development</i></p><p><blockquote><i>COVID-19疫苗开发</i></blockquote></p><p> <ul> <li>Moderna COVID-19 Vaccine (SpikevaxTM): Received Emergency Use Authorization (EUA) from theU.S. Food and Drug Administration(U.S.FDA), and approvals by theEuropean CommissionandSwissmedicfor a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level</li> <li>U.S.FDA granted Priority Review to the Biologics License Application (BLA) for the Moderna COVID-19 vaccine</li> <li>New data from Phase 2/3 KidCOVE study of mRNA-1273 in children ages 6 to under 12 years shows vaccine efficacy of 100% two weeks after first dose of mRNA-1273 at 50 µg dose level, using the Phase 3 COVE study primary case definition for COVID-19</li> <li>The Phase 1 study of next-generation vaccine candidate against COVID-19 (mRNA-1283) is fully enrolled;Modernaexpects to begin Phase 2 study of mRNA-1283 soon; mRNA-1283 is being developed as a potential refrigerator-stable mRNA vaccine</li> </ul> <i>Respiratory Vaccines</i></p><p><blockquote><ul><li>Moderna新冠肺炎疫苗（SpikevaxTM）：获得美国紧急使用授权（EUA）。美国食品药品监督管理局 (U.S.FDA)、欧盟委员会和瑞士医疗公司批准 50 µg 剂量水平的 Moderna COVID-19 疫苗加强剂量</li><li>美国FDA授予Moderna COVID-19疫苗生物制品许可申请（BLA）优先审查</li><li>在6至12岁以下儿童中进行的mRNA-1273的2/3期KidCOVE研究的新数据显示，使用COVID-19的3期COVE研究主要病例定义，在50 µg剂量水平下首次接种mRNA-1273两周后，疫苗效力为100%</li><li>针对新冠肺炎（mRNA-1283）的下一代候选疫苗1期研究已全部入组；Moderna预计很快开始mRNA-1283的2期研究；mRNA-1283正在被开发为一种潜在的冰箱稳定mRNA疫苗</li></ul><i>呼吸道疫苗</i></blockquote></p><p> <ul> <li>Phase 1 portion of the Phase 1/2 study of quadrivalent seasonal flu vaccine candidate (mRNA-1010) fully enrolled, preparations for Phase 2 portion of the study are ongoing</li> <li>Pivotal Phase 2/3 study of respiratory syncytial virus (RSV) vaccine candidate (mRNA-1345) in older adults expected to begin in 2021; study expected to enroll approximately 34,000 participants, subject to agreement with regulatory authorities</li> <li>New combination respiratory vaccines: Moderna COVID-19 vaccine + flu vaccine candidate (mRNA-1073) and pediatric RSV + hMPV vaccine candidate (mRNA-1365)</li> </ul> <i>Latent Vaccines</i></p><p><blockquote><ul><li>四价季节性流感疫苗候选疫苗（mRNA-1010）的1/2期研究的1期部分已全部入组，研究的2期部分准备工作正在进行中</li><li>呼吸道合胞病毒（RSV）候选疫苗（mRNA-1345）在老年人中的关键2/3期研究预计将于2021年开始；研究预计将招募约 34,000 名参与者，但须与监管机构达成协议</li><li>新型呼吸道联合疫苗：Moderna COVID-19疫苗+流感疫苗候选物（mRNA-1073）和儿科RSV+hMPV疫苗候选物（mRNA-1365）</li></ul><i>潜伏疫苗</i></blockquote></p><p> <ul> <li>First participants dosed in Phase 3 study of cytomegalovirus (CMV) vaccine candidate (mRNA-1647)</li> <li>Phase 1 study of EBV vaccine candidate (mRNA-1189)expected to start soon</li> <li>New EBV therapeutic vaccine candidate (mRNA-1195)</li> </ul> <i>Therapeutics</i></p><p><blockquote><ul><li>巨细胞病毒 (CMV) 候选疫苗 (mRNA-1647) 3 期研究的首批参与者接种疫苗</li><li>EBV候选疫苗（mRNA-1189）1期研究有望很快启动</li><li>新型EBV治疗性候选疫苗（mRNA-1195）</li></ul><i>治疗</i></blockquote></p><p> <ul> <li>Phase 2 randomized, placebo-controlled study of personalized cancer vaccine (PCV) (mRNA-4157) in combination with Merck’s pembrolizumab (KEYTRUDA®), compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma is fully enrolled; data readout expected in the fourth quarter of 2022</li> <li>Enrollment of the first cohort in Propionic Acidemia candidate (mRNA-3927) Phase 1/2Paramountstudy is complete</li> <li>First patient dosed in Phase 1 study of Methylmalonic Acidemia (MMA) candidate (mRNA-3705)</li> <li>Investigational New Drug application (IND) open and Orphan Drug Designation granted byU.S.FDA for GSD1a program (mRNA-3745)</li> <li>Providing investigational mRNA Crigler-Najjar Syndrome Type 1 (CN-1) therapy (mRNA-3351) toInstitute for Life Changing Medicines(ILCM) free of charge; CN-1 is an ultra-rare disease</li> <li>Introducing inhaled pulmonary therapeutics modality; IND-enabling first-in-human studies of Vertex andModernamRNA cystic fibrosis (CF) therapeutic (VXc-522) are ongoing in new pulmonary modality</li> </ul> Moderna continues to scale, now with 37 programs in development across 34 development candidates1, including 21 in ongoing clinical studies. The Company’s updated pipeline can be found atwww.modernatx.com/pipeline.Modernaand collaborators have published nearly 100 peer reviewed manuscripts.</p><p><blockquote><ul><li>个性化癌症疫苗（PCV）（mRNA-4157）联合默沙东帕博利珠单抗（KEYTRUDA）的2期随机、安慰剂对照研究®)，与单用派姆单抗相比，用于辅助治疗高危切除黑色素瘤完全入组；预计2022年第四季度数据读数</li><li>丙酸血症候选药物（mRNA-3927）1/2期Paramount研究完成首个队列入组</li><li>甲基丙二酸血症（MMA）候选药物（mRNA-3705）的1期研究中首例患者给药</li><li>GSD1a 计划 (mRNA-3745) 获得 byU.S.FDA 开放和孤儿药资格的研究性新药申请 (IND)</li><li>向改变生活药物研究所(ILCM)免费提供研究性mRNA Crigler-Najjar综合征1型(CN-1)疗法(mRNA-3351)；CN-1是一种极其罕见的疾病</li><li>引入吸入肺治疗模式；Vertex 和 ModernaMRNA 囊性纤维化 (CF) 治疗剂 (VXc-522) 的 IND 首例人体研究正在新的肺部模式中进行</li></ul>Moderna 继续扩大规模，目前有 37 个项目正在开发中，涉及 34 个开发候选项目1，其中 21 个项目正在进行临床研究。该公司更新后的管道可在 www.modernatx.com/pipeline.moderna 上找到，合作者已经发表了近 100 篇同行评审稿件。</blockquote></p><p> <b>2021 Updated Financial Framework</b></p><p><blockquote><b>2021年更新的财务框架</b></blockquote></p><p></p><p> <ul> <li><b>For Expected Delivery in Fiscal Year (FY) 2021:</b>Expected to realize product sales for FY 2021 between$15 billionand$18 billion.</li> <li></li> <li><b>Vaccine Dose Deliveries for FY 2021:</b>The Company expects deliveries of its COVID-19 vaccine in FY 2021 to be between 700 million and 800 million doses at the 100 µg dose level. Key variables impacting output include longer delivery lead times for international shipments and exports that may shift deliveries to early 2022, temporary impact from expansion of fill/finish capacity and ramp up of product release to market.</li> <li><b>Cost of Sales:</b>Cost of sales as percentage of product sales are expected to be between 16-17% for FY 2021.</li> <li><b>2021 Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses:</b>Continue to expect quarter over quarter cost increases in R&D and SG&A expenses during 2021 as commercial and research and development activities and expenses ramp up.</li> <li><b>Tax Rate:</b>The Company now expects the effective tax rate for 2021 to be in the high single digit range as a result of the forecasted global sales mix and utilization of the accumulated net operating loss carry-forward of$2.3 billion.</li> <li><b>Capital Expenditures:</b>Expect approximately$0.4 billionof capital investments for 2021.</li> <li><b>Share Repurchase Program:</b>The Board of Directors has authorized a share repurchase program of up to$1 billionover a two-year period to return excess capital to shareholders. No shares were repurchased through the end of the third quarter.</li> </ul> <b>2022 Revenue Drivers</b></p><p><blockquote><ul><li><b>对于2021财年（FY）的预期交付：</b>预计 2021 财年产品销售额将在 150 亿至 180 亿美元之间。</li><li></li><li><b>2021财年的疫苗剂量交付：</b>该公司预计 2021 财年 100 µg 剂量水平的 COVID-19 疫苗交付量将在 7 亿至 8 亿剂之间。影响产量的关键变量包括国际运输和出口的交付周期延长，这可能会将交付时间推迟到 2022 年初，灌装/精加工能力扩张的暂时影响以及产品投放市场的增加。</li><li><b>销售成本：</b>2021财年，销售成本占产品销售的百分比预计在16-17%之间。</li><li><b>2021 年研发 (R&D) 和销售、一般和行政 (SG&A) 费用：</b>随着商业和研发活动及费用的增加，预计 2021 年研发和 SG&A 费用将逐季增加。</li><li><b>税率：</b>由于预测的全球销售组合和累计净运营亏损结转 23 亿美元，该公司目前预计 2021 年的有效税率将在高个位数范围内。</li><li><b>资本开支：</b>预计 2021 年资本投资约为 4 亿美元。</li><li><b>股份购回计划：</b>董事会已授权在两年内实施高达 10 亿美元的股票回购计划，以将多余资本返还给股东。截至第三季度末，没有股票被回购。</li></ul><b>2022 年收入驱动因素</b></blockquote></p><p> They expect several dynamics will drive 2022 revenues:</p><p><blockquote>他们预计几个动态将推动 2022 年收入：</blockquote></p><p> <ul> <li><b>APAs Signed:</b>The Company has signed approximately$17 billionof advance purchase agreements (APAs) for delivery in 2022.</li> <li><b>APAs with Options:</b>The Company anticipates the exercise of options under 2022 APAs of up to$3 billion.</li> <li><b>U.S.Fall 2022 Booster Market:</b>Subject to receipt of a BLA or sBLA for boosters prior to the fall booster season, the Company anticipates commercial booster market sales could be up to$2 billion.</li> </ul> Based on these three revenue drivers, the Company believes 2022 sales could be in the range of$17 billionto$22 billion. The Company continues to have discussions for 2022 APAs with governments and international organizations, including COVAX, thePan American Health Organization(PAHO) and theAfrican Union.</p><p><blockquote><ul><li><b>APA签署：</b>该公司已签署约 170 亿美元的预购协议 (APA)，将于 2022 年交付。</li><li><b>具有选项的APA：</b>该公司预计 2022 年 APA 下的期权行使量高达 30 亿美元。</li><li><b>美国2022 年秋季助推器市场：</b>如果在秋季助推器季节之前收到助推器的 BLA 或 sBLA，该公司预计商业助推器市场销售额可能高达 20 亿美元。</li></ul>根据这三个收入驱动因素，该公司认为 2022 年销售额可能在 170 亿至 220 亿美元之间。该公司继续与各国政府和国际组织讨论 2022 年 APA，包括 COVAX、泛美卫生组织 (PAHO) 和非洲联盟。</blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"MRNA":"Moderna, Inc."},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1101079537","content_text":"Moderna stock plunged 9% after it cut its Covid-19 vaccine sales forecast for the year and missed earnings and revenue expectations for the third quarter.\n\nModerna Q3 revenue $4.969 bln vs. $157 mln a year ago; FactSet consensus $6.200 bln;\n\n\nModerna Q3 EPS $7.70 vs loss 59 cents a share a year ago; FactSet consensus $9.09;\n\n\nModerna, Inc. today reported financial results and provided business updates for the third quarter of fiscal year 2021.\nQ3 total revenue of$5.0 billion, net income of$3.3 billionand diluted EPS of$7.70\nU.S.FDA granted Priority Review to the Biologics License Application for Moderna’s COVID-19 vaccine\nInterim data from Phase 2/3 KidCOVE study of mRNA-1273 in children ages 6 to under 12 years shows vaccine efficacy of 100% two weeks after first dose of mRNA-1273 at 50 µg dose level\nFirst participants dosed in Phase 3 study of cytomegalovirus (CMV) vaccine candidate (mRNA-1647)\nIntroducing inhaled pulmonary therapeutics modality:Vertex andModernacystic fibrosis mRNA therapeutic (VXc-522) IND-enabling first-in-human studies ongoing\nCompany continues to scale with 37 programs in development, including 21 in ongoing clinical studies\nUpdates and recent progress include:\nCOVID-19 Vaccine Development\n\nModerna COVID-19 Vaccine (SpikevaxTM): Received Emergency Use Authorization (EUA) from theU.S. Food and Drug Administration(U.S.FDA), and approvals by theEuropean CommissionandSwissmedicfor a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level\nU.S.FDA granted Priority Review to the Biologics License Application (BLA) for the Moderna COVID-19 vaccine\nNew data from Phase 2/3 KidCOVE study of mRNA-1273 in children ages 6 to under 12 years shows vaccine efficacy of 100% two weeks after first dose of mRNA-1273 at 50 µg dose level, using the Phase 3 COVE study primary case definition for COVID-19\nThe Phase 1 study of next-generation vaccine candidate against COVID-19 (mRNA-1283) is fully enrolled;Modernaexpects to begin Phase 2 study of mRNA-1283 soon; mRNA-1283 is being developed as a potential refrigerator-stable mRNA vaccine\n\nRespiratory Vaccines\n\nPhase 1 portion of the Phase 1/2 study of quadrivalent seasonal flu vaccine candidate (mRNA-1010) fully enrolled, preparations for Phase 2 portion of the study are ongoing\nPivotal Phase 2/3 study of respiratory syncytial virus (RSV) vaccine candidate (mRNA-1345) in older adults expected to begin in 2021; study expected to enroll approximately 34,000 participants, subject to agreement with regulatory authorities\nNew combination respiratory vaccines: Moderna COVID-19 vaccine + flu vaccine candidate (mRNA-1073) and pediatric RSV + hMPV vaccine candidate (mRNA-1365)\n\nLatent Vaccines\n\nFirst participants dosed in Phase 3 study of cytomegalovirus (CMV) vaccine candidate (mRNA-1647)\nPhase 1 study of EBV vaccine candidate (mRNA-1189)expected to start soon\nNew EBV therapeutic vaccine candidate (mRNA-1195)\n\nTherapeutics\n\nPhase 2 randomized, placebo-controlled study of personalized cancer vaccine (PCV) (mRNA-4157) in combination with Merck’s pembrolizumab (KEYTRUDA®), compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma is fully enrolled; data readout expected in the fourth quarter of 2022\nEnrollment of the first cohort in Propionic Acidemia candidate (mRNA-3927) Phase 1/2Paramountstudy is complete\nFirst patient dosed in Phase 1 study of Methylmalonic Acidemia (MMA) candidate (mRNA-3705)\nInvestigational New Drug application (IND) open and Orphan Drug Designation granted byU.S.FDA for GSD1a program (mRNA-3745)\nProviding investigational mRNA Crigler-Najjar Syndrome Type 1 (CN-1) therapy (mRNA-3351) toInstitute for Life Changing Medicines(ILCM) free of charge; CN-1 is an ultra-rare disease\nIntroducing inhaled pulmonary therapeutics modality; IND-enabling first-in-human studies of Vertex andModernamRNA cystic fibrosis (CF) therapeutic (VXc-522) are ongoing in new pulmonary modality\n\nModerna continues to scale, now with 37 programs in development across 34 development candidates1, including 21 in ongoing clinical studies. The Company’s updated pipeline can be found atwww.modernatx.com/pipeline.Modernaand collaborators have published nearly 100 peer reviewed manuscripts.\n2021 Updated Financial Framework\n\nFor Expected Delivery in Fiscal Year (FY) 2021:Expected to realize product sales for FY 2021 between$15 billionand$18 billion.\n\nVaccine Dose Deliveries for FY 2021:The Company expects deliveries of its COVID-19 vaccine in FY 2021 to be between 700 million and 800 million doses at the 100 µg dose level. Key variables impacting output include longer delivery lead times for international shipments and exports that may shift deliveries to early 2022, temporary impact from expansion of fill/finish capacity and ramp up of product release to market.\nCost of Sales:Cost of sales as percentage of product sales are expected to be between 16-17% for FY 2021.\n2021 Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses:Continue to expect quarter over quarter cost increases in R&D and SG&A expenses during 2021 as commercial and research and development activities and expenses ramp up.\nTax Rate:The Company now expects the effective tax rate for 2021 to be in the high single digit range as a result of the forecasted global sales mix and utilization of the accumulated net operating loss carry-forward of$2.3 billion.\nCapital Expenditures:Expect approximately$0.4 billionof capital investments for 2021.\nShare Repurchase Program:The Board of Directors has authorized a share repurchase program of up to$1 billionover a two-year period to return excess capital to shareholders. No shares were repurchased through the end of the third quarter.\n\n2022 Revenue Drivers\nThey expect several dynamics will drive 2022 revenues:\n\nAPAs Signed:The Company has signed approximately$17 billionof advance purchase agreements (APAs) for delivery in 2022.\nAPAs with Options:The Company anticipates the exercise of options under 2022 APAs of up to$3 billion.\nU.S.Fall 2022 Booster Market:Subject to receipt of a BLA or sBLA for boosters prior to the fall booster season, the Company anticipates commercial booster market sales could be up to$2 billion.\n\nBased on these three revenue drivers, the Company believes 2022 sales could be in the range of$17 billionto$22 billion. The Company continues to have discussions for 2022 APAs with governments and international organizations, including COVAX, thePan American Health Organization(PAHO) and theAfrican Union.","news_type":1,"symbols_score_info":{"MRNA":0.9}},"isVote":1,"tweetType":1,"viewCount":1181,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":2,"subscribersOnly":false,"subscribersOnlyAccessible":false,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/848473492"}
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