Davidtan0629
2021-11-04
Ok
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第三季度营收为49.69亿美元，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.今天报告了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，稀释后每股收益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FDA授予Moderna新冠疫苗生物制品许可申请优先审查</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岁以下儿童中进行的2/3期KidCOVE研究的中期数据显示，在50 μ g剂量水平的mRNA-1273首次给药后两周，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期研究中的第一批参与者接受给药</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>介绍吸入性肺部治疗方式：Vertex和现代囊性纤维化mRNA治疗剂(VXc-522)正在进行首次人体研究</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>更新和最近的进展包括：</b></blockquote></p><p> <i>COVID-19 Vaccine Development</i></p><p><blockquote><i>COVID-19疫苗研发</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>现代新冠肺炎疫苗（SpikevaxTM）：获得美国紧急使用授权（EUA）美国食品和药物管理局(U.S.FDA)以及欧盟委员会和SwissMedic批准50µg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>mRNA-1273在6岁至12岁以下儿童中的2/3期KidCOVE研究的新数据显示，使用3期COVE研究COVID-19的主要病例定义，在50µg剂量水平的mRNA-1273首次给药后两周，疫苗效力为100%</li><li>针对新冠肺炎的下一代候选疫苗（mRNA-1283）的1期研究已全面入组；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>四价季节性流感候选疫苗（mRNA-1010）1/2期研究的1期部分已全面入组，该研究的2期部分正在筹备中</li><li>老年人呼吸道合胞病毒（RSV）候选疫苗（mRNA-1345）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>新型联合呼吸道疫苗：Moderna COVID-19疫苗+流感候选疫苗（mRNA-1073）和儿科RSV+hMPV候选疫苗（mRNA-1365）</li></ul><i>潜在疫苗</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期研究中的第一批参与者接受给药</li><li>EBV候选疫苗（mRNA-1189）的1期研究预计即将开始</li><li>新型EBV治疗候选疫苗（mRNA-1195）</li></ul><i>治疗学</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）联合默克公司的派姆单抗（KEYTRUDA®），与帕博利珠单抗单药相比，用于高危切除黑色素瘤的辅助治疗已完全入组；预计将于2022年第四季度公布数据</li><li>丙酸血症候选药物（mRNA-3927）1/2期PARAMOUNT研究首个队列的入组已完成</li><li>甲基丙二酸血症（MMA）候选药物（mRNA-3705）1期研究中的首例患者给药</li><li>美国FDA授予GSD1a项目(mRNA-3745)的新药研究申请(IND)开放和孤儿药资格</li><li>向改变生活药物研究所（ILCM）免费提供研究性mRNA克里格勒-纳贾尔综合征1型（CN-1）疗法（mRNA-3351）；CN-1是一种极其罕见的疾病</li><li>介绍吸入性肺部治疗模式；Vertex和ModernamRNA囊性纤维化(CF)治疗剂(VXc-522)的首次人体研究正在以新的肺部模式进行</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。该公司更新的管道可在www.modernatx.com/pipeline.moderna上找到，合作者已发表近100篇同行评审手稿。</blockquote></p><p> <b>2021 Updated Financial Framework</b></p><p><blockquote><b>2021年更新财务框架</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150亿美元至180亿美元之间。</li><li></li><li><b>2021财年疫苗剂量交付：</b>该公司预计2021财年100µg剂量水平的COVID-19疫苗的交付量将在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较长（可能将交付时间推迟到2022年初）、灌装/精加工产能扩张以及产品投放市场的增加带来的暂时影响。</li><li><b>销售成本：</b>2021财年，销售成本占产品销售额的百分比预计在16-17%之间。</li><li><b>2021年研发(R&D)以及销售、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费用的成本将逐季增加。</li><li><b>税率：</b>由于预测的全球销售组合以及23亿美元累计净运营亏损结转的利用，该公司目前预计2021年的有效税率将处于高个位数范围。</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>股份回购计划：</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，以向股东返还多余资本。截至第三季度末，没有回购任何股票。</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>他们预计有几种动态将推动2022年的收入：</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签署人：</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>带选项的APA：</b>该公司预计根据2022年APA行使的期权金额高达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>基于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（包括COVAX、泛美卫生组织(PAHO)和非洲联盟）讨论2022年APA。</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下调了今年Covid-19疫苗销售预期，第三季度盈利和收入未达到预期，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第三季度营收为49.69亿美元，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.今天报告了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，稀释后每股收益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FDA授予Moderna新冠疫苗生物制品许可申请优先审查</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岁以下儿童中进行的2/3期KidCOVE研究的中期数据显示，在50 μ g剂量水平的mRNA-1273首次给药后两周，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期研究中的第一批参与者接受给药</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>介绍吸入性肺部治疗方式：Vertex和现代囊性纤维化mRNA治疗剂(VXc-522)正在进行首次人体研究</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>更新和最近的进展包括：</b></blockquote></p><p> <i>COVID-19 Vaccine Development</i></p><p><blockquote><i>COVID-19疫苗研发</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>现代新冠肺炎疫苗（SpikevaxTM）：获得美国紧急使用授权（EUA）美国食品和药物管理局(U.S.FDA)以及欧盟委员会和SwissMedic批准50µg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>mRNA-1273在6岁至12岁以下儿童中的2/3期KidCOVE研究的新数据显示，使用3期COVE研究COVID-19的主要病例定义，在50µg剂量水平的mRNA-1273首次给药后两周，疫苗效力为100%</li><li>针对新冠肺炎的下一代候选疫苗（mRNA-1283）的1期研究已全面入组；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>四价季节性流感候选疫苗（mRNA-1010）1/2期研究的1期部分已全面入组，该研究的2期部分正在筹备中</li><li>老年人呼吸道合胞病毒（RSV）候选疫苗（mRNA-1345）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>新型联合呼吸道疫苗：Moderna COVID-19疫苗+流感候选疫苗（mRNA-1073）和儿科RSV+hMPV候选疫苗（mRNA-1365）</li></ul><i>潜在疫苗</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期研究中的第一批参与者接受给药</li><li>EBV候选疫苗（mRNA-1189）的1期研究预计即将开始</li><li>新型EBV治疗候选疫苗（mRNA-1195）</li></ul><i>治疗学</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）联合默克公司的派姆单抗（KEYTRUDA®），与帕博利珠单抗单药相比，用于高危切除黑色素瘤的辅助治疗已完全入组；预计将于2022年第四季度公布数据</li><li>丙酸血症候选药物（mRNA-3927）1/2期PARAMOUNT研究首个队列的入组已完成</li><li>甲基丙二酸血症（MMA）候选药物（mRNA-3705）1期研究中的首例患者给药</li><li>美国FDA授予GSD1a项目(mRNA-3745)的新药研究申请(IND)开放和孤儿药资格</li><li>向改变生活药物研究所（ILCM）免费提供研究性mRNA克里格勒-纳贾尔综合征1型（CN-1）疗法（mRNA-3351）；CN-1是一种极其罕见的疾病</li><li>介绍吸入性肺部治疗模式；Vertex和ModernamRNA囊性纤维化(CF)治疗剂(VXc-522)的首次人体研究正在以新的肺部模式进行</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。该公司更新的管道可在www.modernatx.com/pipeline.moderna上找到，合作者已发表近100篇同行评审手稿。</blockquote></p><p> <b>2021 Updated Financial Framework</b></p><p><blockquote><b>2021年更新财务框架</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150亿美元至180亿美元之间。</li><li></li><li><b>2021财年疫苗剂量交付：</b>该公司预计2021财年100µg剂量水平的COVID-19疫苗的交付量将在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较长（可能将交付时间推迟到2022年初）、灌装/精加工产能扩张以及产品投放市场的增加带来的暂时影响。</li><li><b>销售成本：</b>2021财年，销售成本占产品销售额的百分比预计在16-17%之间。</li><li><b>2021年研发(R&D)以及销售、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费用的成本将逐季增加。</li><li><b>税率：</b>由于预测的全球销售组合以及23亿美元累计净运营亏损结转的利用，该公司目前预计2021年的有效税率将处于高个位数范围。</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>股份回购计划：</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，以向股东返还多余资本。截至第三季度末，没有回购任何股票。</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>他们预计有几种动态将推动2022年的收入：</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签署人：</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>带选项的APA：</b>该公司预计根据2022年APA行使的期权金额高达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>基于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（包括COVAX、泛美卫生组织(PAHO)和非洲联盟）讨论2022年APA。</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":757,"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,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/848701529"}
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