Rotavirus vaccine (Bio-Farma/Murdoch-Childrens-Research-Institute)

关注并星标CPHI制药在线2023年(第八届)疫苗中国领导者年会是中国乃至亚洲顶尖的疫苗行业战略性峰会，深度聚焦疫苗全产业链的创新生产与国家化进程。本届年会以“聚焦创新，放眼未来”为主题，邀请来自全球的疫苗研发生产企业、生物技术公司、科研院所、监管机构等负责疫苗研发、生产、商业化的高管、专家及决策者，通过两个论坛共同探讨当前全球疫苗发展趋势、政策动向、研发热点、工艺技术、商业化战略、国际化进程等专题，旨在为疫苗行业领导者搭建一个高效的交流平台，共同推动疫苗行业的健康稳定发展！为期2天的大会将以主题演讲、高层对话、展览展示、1对1系统约见等形式展开，席位火热征集中，现在报名参与还将享受早鸟特惠！大会为您呈现疫苗行业领袖风采，洞见疫苗前沿技术进展，挖掘最佳战略合作机遇。组委会议程安排时间议程4.27上午疫苗政策解读与市场趋势4.27下午质量为先 —疫苗生产工艺与运输储存预见未来 —mRNA疫苗专场4.28上午品种为王 — 疫苗产品研发与临床进展4.28下午技术为核 — 新型疫苗技术创新与突破部分确认发言嘉宾 Jerome Hahn Kim 总干事国际疫苗研究所Jerome H. Kim, M.D., is an international expert on the development and evaluation of vaccines and is the Director General of the International Vaccine Institute (IVI), whose mission is to discover, develop and deliver safe, effective and affordable vaccines for Global Health. IVI’s oral cholera vaccine is used around the world to prevent this deadly diarrheal disease.  IVI’s typhoid conjugate vaccine, tech-transferred to SK bioscience received regulatory approval in the Republic of Korea (May 2022) and to PT Bio Farma, Indonesia (approval expected in 2022).  IVI's work with companies developing COVID-19 vaccines may contribute 1.2 billion doses to the global COVAX facility – providing COVID-19 vaccines for people in low- and middle-income countries. Prior to IVI, he was the Principal Deputy, US Military HIV Research Program and Chief, Laboratory of Molecular Virology and Pathogenesis at the Walter Reed Army Institute of Research, and the US Army Program Manager for HIV Vaccines.  He led the Army’s RV144 Phase III HIV vaccine trial that showed efficacy in the prevention of HIV-1. Dr. Kim is an Adjunct Professor of Medicine at the Uniformed Services University, USA, and at Yonsei University Graduate School of Public Health and a Distinguished Visiting Professor at Seoul National University, Korea. He has authored over 300 publications. He is a graduate of the University of Hawaii, with high honors in History and highest honors in Biology and received his M.D. from the Yale University School of Medicine. Dr. Kim has received numerous awards: John Maher Award for Research Excellence, USUHS, 2013; Department of the Army Research and Development Achievement Award for Technical Excellence, 2013; Asia Pacific Vaccine Excellence Lifetime Achievement Award, 2021; Medal of Honor for Civil Merit from the Korean government, 2022. 张 伟 先生 会长中国药品监督管理研究会 王佑春 博士 所长中国医学科学院医学生物学研究所中国医学科学院医学生物学研究所所长，中国医学科学院学术咨询委员会学部委员，北京协和医学院长聘教授，享受国务院特殊津贴专家，“新世纪百千万人才工程”国家级人选。获原北京医科大学流行病学专业医学博士学位，英国伦敦大学学院（UCL）病毒学专业哲学博士学位。长期从事医学病毒学的流行病学、分子生物学以及相关产品的质量控制方法研究。近年来，主要集中于新突发病毒性传染病假病毒的构建以及在病毒变异、中和抗体和药物筛选和检测等方面的应用研究。以第一或通讯作者发表论文320 余篇，其中发表在Cell（3 篇），Nature（4 篇），Science（1篇)等SCI 杂志上150 余篇。以第一完成人获：国家科技进步二等奖1 项；北京市科技进步术一等奖2 项，中华医学科技一等奖和中华预防医学会一等奖各1 项。第十八届吴杨药学奖，中国药学发展奖食品药品质量检测技术奖特别贡献奖，全国科技系统抗击新冠肺炎疫情先进个人。中华医学会病毒学专业委员会前任主任委员，现为WHO 生物制品标准化委员会委员，中华医学会微生物和免疫学委员会副主任委员，药典委员会疫苗专业委员会主任委员。 王 宾 教授 教授/创始人复旦大学/艾棣维欣生物王宾，博士，特聘教授，博士生导师，艾棣维欣生物技术公司创始人。美国辛辛那提大学儿童医院博士，美国wistar研究所博士后。曾任美国宾夕法尼亚大学医学院任助研和助教授、新疆大学特聘教授、中国农业大学特聘教授。现任复旦大学特聘教授、国际疫苗研究所(IVI) 科学委员会委员、国际疫苗学会会员、中国疫苗行业协会核酸疫苗分会主任委员。同时担任了国际学术杂志的编委会委员职务在 1990 年在美国做博士后工作期间，和导师 David Weiner 教授发明了 DNA 疫苗技术成为世界上最早发现该技术的团队之一。随即开展了世界上第一个DNA 疫苗临床研究，为 DNA 疫苗技术发展定了基础。自 1995 年以来，发表了 160 多篇 SCI 论文，获得了美国等各国发明专利 40 多项、中国发明专利 22 项。完成3 项人用治疗性疫苗佐剂临床研究、开展了一项新型佐剂 RSV 疫苗临床 I 期研究、开展了新冠 DNA 疫苗、II 和 II 期临床试验。主持和参与了国家“863”重大项目、自然科学基金重点项目、传染病重大专项和新药创制专项和十四五揭榜挂帅重点项目等课题 40 多项。获得了 1项北京市和 2 项上海市发明专利金奖。 巢守柏 博士 首席运营官康希诺生物巢守柏博士在全球生物制药领域从事新药研发、制造、质量、供应链、市场等方面工作30余年，主导或参与了多个全球重磅产品的研发和上市，对国际GMP法规有深刻理解。巢守柏博士拥有中国科学院硕士学位，加拿大滑铁卢大学生化工程专业博士学位，并在滑铁卢大学生化工程系完成了博士后研究。巢博士2018年加入康希诺生物并任首席运营官，负责公司的生产、质量、供应链等运营管理工作。加入康希诺之前，任阿斯利康制药公司高级副总裁，负责全球疫苗、生物制药、生物类似药业务，此前曾就职于赛诺菲巴斯德、辉瑞等知名跨国公司。 黄  镇 先生 副董事长沃森生物黄镇先生为云南沃森生物技术股份有限公司首席科学家、董事、副董事长，玉溪沃森生物技术有限公司、玉溪泽润生物技术有限公司董事长，制药工程硕士，正高级工程师，投身于生物制品行业42年，拥有丰富的疫苗研发和生产管理经验，成功建立了多项细菌性疫苗核心研发技术平台，开发成功市场前景广阔的疫苗产品10个，其中有以全球第二、国内首支13价肺炎球菌结合疫苗为代表的7个品种、10个品规的产品上市销售。黄镇尤其在细菌性多糖疫苗、细菌性多糖结合疫苗的研发方面具有国际一流、国内领先的技术水平。Mr. Huang Zhen is the chief scientist, director and vice chairman of Yunnan Walvax Biotechnology Co., Ltd., the chairman of Yuxi Walvax Biotechnology Co., Ltd. and Yuxi Zerun Biotechnology Co., Ltd., master of pharmaceutical engineering, senior engineer. He is devoted to the biological products industry for 42 years, has rich experience in vaccine R&D and production management, successfully established a number of bacterial vaccine core R&D technology platforms, and developed 10 vaccine products with broad market prospects, including the world's second, The first domestic 13-valent pneumococcal conjugate vaccine represented by 7 varieties and 10 specifications of products was put on sale. Mr. Huang Zhen especially has the world-class and domestic leading technical level in the research and development of bacterial polysaccharide vaccines and bacterial polysaccharide conjugate vaccines. 杜笑寒 博士 亚太区外部研发负责人赛诺菲巴斯德作为对外研发部亚太地区负责人，杜笑寒博士负责亚太地区所有疫苗相关项目的鉴定和评估，用以支持集团的全球疫苗研究管线。在他的主导下，赛诺菲巴斯德签署并完成了与墨尔本大学，厦门大学，以及中国科学院的合作研究项目，启动了与韩国，日本，和美国等国生物科技公司的可行性研究，并成功地与厦门万泰沧海就其重组轮状病毒疫苗项目签署了排他性全球许可协议。杜笑寒博士在疫苗领域拥有20年的产品开发和商业拓展相关专业经验。在加入赛诺菲巴斯德之前，杜笑寒博士担任过美国ALTRAVAX公司的共同创始人和首席运营官，先声药业疫苗研发执行总监以及先声疫苗研究所所长， 以及美国MAXYGEN公司的传染病部资深科学家和项目负责人。他先后共领导过多项预防性疫苗和治疗性疫苗的临床前开发工作，参加于FDA沟通，并获得过一项CDE临床试验批件。在过去的十年里，杜笑寒博士还负责领导与全球各制药公司和学术界的业务往来；并在项目引进和对外许可的诸多环节上担当过重任。杜笑寒博士本科毕业于山东大学微生物学专业，拥有中国科学院微生物研究所微生物学理学硕士学位和美国特拉华大学的生物科学博士学位。博士毕业以后，杜笑寒于1998年至2001年期间在美国哥伦比亚大学医学院从事博士后研究工作。 金 侠 博士 CEO医克生物金侠，博士，现任医克生物(Immuno Cure BioTech Ltd.)行政总裁(CEO)。曾任上海塞伦生物技术股份有限公司（SH688163）副总经理、首席科学家。原任复旦大学附属上海市公共卫生临床中心教授，疫苗与免疫研究中心主任。之前任中国科学院特聘研究员(核心骨干)，兼任中科院分子病毒与免疫重点实验室副主任、中科院上海巴斯德研究疫苗中心执行主任。曾任美国纽约私立罗彻斯特大学（University of Rochester）助教授、副教授、博士生导师（2001-2012年）。主要研究方向为人类传染病的发病机制、免疫应答，及相关疫苗研发。在国际知名期刊Science，J. Exp. Med.，J. Clin. Inv.，Nat. Commn.等发表英文论文140余篇。 吴 克 博士 CEO博沃生物吴克博士，湖北省政府特聘产业教授，中国疫苗行业协会糖疫苗专委会副主委、国际合作促进委员会委员。具有欧美留学深造经历，是中欧国际工商学院和长江商学院校友。曾任中华预防医学会生物制品委员会委员、中国微生物学会医学微生物学会委员、湖北省免疫学会常务理事以及武汉市政协委员等职。曾在卫生部武汉生物制品研究所任研究生导师、科研处处长等职；2004年创建惠生集团生物医药板块，任上海泽润生物执行总裁、企业负责人。2011年创办博沃生物（获评“亚太地区最佳初创公司”）。主持过国家重大研发计划、863项目、重大新药创制专项开发，带领团队当选首届和第二届“湖北省自主创业战略团队”。2020年获评德勤''中国明日之星''称号，是唯一获奖疫苗企业。 张立杰 博士 副总经理智飞绿竹张立杰，博士,毕业于西北农林科技大学，生物技术专业。曾在宁夏回族自治区农牧厅工作近十年，从事政府资助的全区科研及农业推广项目管理。攻读博士学位期间主要从事脂肪代谢、基因芯片数据分析等研究，在加拿大蒙特利尔大学圣加斯汀医院完成博士论文研究内容。2007年获得博士学位，就职华都诗华股份有限公司任研发部经理，主持参与的科研项目有：腺病毒为载体的狂犬病疫苗中试生产、衣原体疫苗研发等，“禽畜鹦鹉热衣原体基因工程亚单位疫苗和检测技术的研究”获2009年北京市科学技术一等奖。2010年3月就职于北京智飞绿竹生物制药有限公司，任副总经理，负责公司科研项目资金申报管理、疫苗产品国际市场拓展、科研技术引进等。现任智飞生物（北京）研发中心副总裁，负责轮状病毒疫苗开发。    轮状病毒灭活疫苗经过7年艰苦的临床前研发，分别在不同动物种属上确定了其有效性和安全性，随后突破放大工艺的瓶颈，最终于2009年提交临床申请，并顺利获批，目前正在临床试验阶段，有望解决目前上市产品所存在的一些问题，成为第二代非复制型轮状病毒疫苗的新型产品。   Zhang Lijie, PhD, graduated from Northwest A & F University, majoring in biotechnology. He worked in Agriculture and Pastoral Department of Ningxia Hui Autonomous Region for nearly 10 years, engaged in the management of government-funded scientific research and agricultural extension projects in the region. During the doctoral study, She mainly engaged in fat metabolism, gene chip data analysis and other researches, and completed the doctoral thesis research in St. Gastine Hospital of Montreal University, Canada. In 2007, he received his doctor's degree and worked as manager of R&D Department of Huadu Shihua Co., LTD., leading and participating in the following scientific research projects: pilot production of rabies vaccine with adenovirus as the carrier, research and development of chlamydia vaccine, etc. "Research on the subunit vaccine and detection technology of Chlamydia pseti gene Engineering" won the first prize of Beijing Science and Technology in 2009.In March 2010, She worked in Beijing Zhifei Luzhu Biopharmaceutical Co., LTD., as the deputy General Manager, responsible for the fund application management of the company's scientific research projects, international market expansion of vaccine products, scientific research technology introduction, etc. Currently, she is the Vice President of Research and Development Center of Zhifei Bio (Beijing), responsible for rotavirus vaccine development.After seven years of painstaking preclinical research and development, the effectiveness and safety of rotavirus inactivated vaccine were determined in different animal species, and then the bottleneck of amplification process was broken. Finally, the clinical application was submitted in 2009 and successfully approved. Currently, it is in the clinical trial stage, which is expected to solve some problems existing in the market products. It is a new product of the second generation of non - replicating rotavirus vaccine. 史 力 博士 董事长怡道生物史力博士是怡道生物科技（苏州）有限公司董事长，前上海泽润生物医药技术有限公司的首席执行官，和云南沃森生物技术有限公司集团副总裁，中组部国家千人，上海市千人，浦东百人特聘专家, 云南省劳动模范，和江苏省双创人才。怡道生物和泽润生物都是专注创新型疫苗和生物医药技术的研发和产品产业化。在过去十年间，史博士领导怡道生物和泽润生物获得了总共6个疫苗产品IND批件， 2个产品上市。在加盟泽润生物之前，史博士有25年在美国从事疫苗，蛋白，和基因治疗生物医药产品研发和管理经验，主要任职于美国健赞（Genzyme）和 默克（Merck）公司，共领导过5个团队，参与了二十多个疫苗及蛋白医药开发项目，经历了多个疫苗和生物医药产品的早期研发，临床研究，产业化，GMP生产， 和上市的全过程。他是美国默克公司 抗宮颈癌疫苗Gardasil® 和Gardasil9®的核心开发团队成员，和制剂发明人。Gardasil®赢得了2006 年美国化学会工业生物技术奖和2007年Prix-Galen 奖（被称为世界医药工业界的Nobel 奖），其年销售额已大近40亿美元。史力获北京大学学士，硕士, 美国加州大学博士,  美国圣地亚哥Scripps 研究所博士后和Lehigh大学MBA训练。他是美中药协（SAPA）前副会长 ，SAPA大费城分会前会长和共同创始人，增担任DIA中国顾问员会成员，上海医药协会，上海生物医药协会，和浦东新区侨联理事，是目前美国药典USP全球生物医药专家委员会和全球疫苗专家委员会成员,  和美国化学会W.H. PETERSON 奖得主。他有论文, 专利, 和会议报告等超过180篇，是12个国际生物/医药期刊和NIH SBIR 基金的特邀评委，编辑委员，和/或评审委员,  国际格力集团(GLG)和Guide-Point等多个顾问组织和投资资本的顾问专家团成员, 以及国家项目和人才专家评委。史博士也在过去或现在担任了北京大学，浙江大学，中山大学，大连理工大学等的客座教授和校外导师等。 李航文 博士 董事长兼首席执行官斯微生物李航文，斯微生物创始人、董事长兼首席执行官。现任同济大学东方医院特聘研究员，曾任美国罗斯维尔癌症中心药理及临床治疗系助理教授，有18年以上的RNA 及癌症免疫治疗领域的经验。研究领域包括肿瘤免疫治疗，RNA 药物及癌症干细胞等，先后发表20余篇SCI 文章及著作，所发布文章累计被引用次数超过2000次。 姜春来 博士 常务副总经理百克生物长春百克生物科技股份公司常务副总经理。吉林大学教授，博士生导师。美国Duke大学Human Vaccine Institute博士后。一直致力于生物疫苗研发及产业化工作，主要研究专长为传染病的致病机理及其疫苗的研究，特别对流感、HPV、TB和HIV病毒及其疫苗具有较深的认识和研究。近年来，共发表专业学术论文60余篇，SCI收入论文50多篇；作为主要发明人，申请发明专利12项，获得授权7项；获得各类科研学术奖励3项；吉林省药学会生物制品委员会副主任委员；中华医学会医学病毒学委员会青年委员会副主任委员；主持国家自然科学基金项目等多项国家级课题。              Executive Vice President of Changchun BCHT Biotechnology Co., Professor of Jilin University, doctoral supervisor, post doctor of Human Vaccine Institute, Duke University, USA. He has been committed to biological vaccine research and industrialization, his main research expertise is the research of pathogenic mechanism of infectious diseases and vaccines, especially a deep understanding and research in influenza, HPV, TB and HIV viruses and its vaccines. In recent years, he has published more than 60 professional academic Papers and more than 50 SCI Papers. As the main inventor, he applied for 12 invention patents and obtained 7 patents, won 3 kinds of academic research awards; Vice Chairman of Biological Products Committee of Jilin Pharmaceutical Society; Vice Chairman of Youth Committee of Medical Virology Committee of Chinese Medical Association. He has presided over a number of National Natural Science Foundation of China projects. 胡振湘 女士 副总经理丽珠生物胡振湘，女，高级工程师，现任珠海市丽珠单抗生物技术有限公司副总经理。拥有20余年生物医药研发经验，专注于生物药CMC工艺研发（细胞培养、纯化与制剂、益生菌大规模发酵）、注册申报与CMC及项目管理。作为项目总负责人获得过4项产品生产批件及6项临床批件，包括2021年获批上市的全球首个艾泽生物类似药产品注射用重组人绒促性素，以及主持创新型融合蛋白疫苗的研发，其中重组新型冠状病毒融合蛋白疫苗丽康V-01已获批国内序贯加强紧急使用。同时作为项目负责人及核心成员，主持完成了多项省级及国家级科技攻关项目。获国际国内专利发明专利十余项。Hu Zhenxiang, female, senior engineer, is currently the Vice Gerenal Manager of Livzon Mabpharm Inc.. With more than 20 years experience in bio-pharmaceutical R＆D, focusing on biologics CMC process development (cell culture, purification and preparation, large-scale fermentation of probiotics), regulatory affairs, and management of CMC and projects. A total of 4 product marketing authorization and 6 clinical approvals were obtained under her lead as the general PM, including the world's first Ovidrel® biosimilar Recombinant Human Choriogonadotropin alfa for Injection, which was granted for BLA approval in 2021, and an innovative fusion protein vaccine LIKANG V-01, which was granted for EUA as booster immunization in 2022. At the same time, as the PM and core member, she presided over and completed a number of provincial and national science and technology projects. And obtained more than ten international and domestic patents for invention. 邵 辉 博士 总裁兼首席执行官依生生物邵辉博士为依生生物制药有限公司首席执行官和董事会执行董事。依生生物是一家专注于免疫类生物大分子药物的研发，生产和国际市场商业化的生物制药公司，业务范围覆盖中国，美国，新加坡, 菲律宾， 阿联酋等国家。邵辉博士拥有20多年生物制药行业的商业运营和投融资经验，荣获北京市特聘专家。他曾经在美国罗氏(Roche)制药担任主任科学家(Principal Scientist), 开展抗肿瘤和代谢类疾病药物的研发，在美国纽约华尔街的Mehta Partners and Kamunting Street Capital担任生物技术分析师和投资经理。邵博士获得美国加利福尼亚大学生物化学博士，纽约大学商学院金融和财务专业MBA， 美国特许金融分析师（CFA）和美国注册会计师 （AICPA）。邵辉博士多次在国际知名学术杂志发表第一作者署名的学术论文，历年来在多个国家的国际医疗行业峰会和资本投资峰会上作为会议主持人和会议嘉宾发表演讲。Dr. David Shao is the President and CEO of Yisheng Biopharma after almost 8 years of serving as the chief financial   officer and global business head of the company since October 2010.    Yisheng Biopharma is a globally   focused biopharmaceutical company discovering, developing and commercializing   innovative immunological biologics with operations in China, the United   States, Singapore，Philippines，UAE，and   certain Southeast Asian countries.Dr. Shao has over 20 years of experience in healthcare investment, capital market and healthcare industry.  He was a Principal Scientist at Roche Pharma, USA focusing on oncology and metabolic disease research, a Senior Healthcare Analyst and investment manager at Mehta Partners and Kamunting Street Capital in New York City.  Dr. Shao received his Ph.D. at University of California, San Diego and MBA at New York University.  Her is also a chartered CFA and AICPA in the US. 郑海发 先生 总经理民海生物郑海发，吉林农业大学动物医学学士，中国农业科学院研究生院农学硕士。现任北京民海生物科技有限公司总经理，深圳康泰生物制品股份有限公司副董事长、首席科学家，国家“863”项目、重大新药创制技术评审专家，国家药典委员会委员。中华预防医学会生物制品分会常委，中华医学会微生物与免疫学分会、中国医药生物技术协会疫苗专业委员会、中国药品监督管理研究会生物制品监督管理研究专业委员会、中国药学会生物药品与质量研究专业委员会委员。   Haifa Zheng, holds a bachelor's degree in animal medicine from Jilin Agricultural University and a master's degree in agriculture from the Graduate School of the Chinese Academy of Agricultural Sciences.He is currently the general manager of Beijing Minhai Biotechnology Co., Ltd., vice chairman and chief scientist of Shenzhen Kangtai Biological Products Co., Ltd., review expert of national 863 project and major new drug creation technology, and member of the National Pharmacopoeia Committee.He is also the member of Standing Committee of Biological Products Branch of Chinese Preventive Medical Association, Committee of Microbiology and Immunology Branch of Chinese Medical Association, Vaccine Committee of China Medical Biotechnology Association, Biological Products Supervision and Management Research Committeeof CSDR, Biological Medicine and Quality Research Committee of Chinese Pharmaceutical Association. 刘  勇 博士 创始人、董事长瑞科生物 刘永江 先生 总经理康乐卫士刘永江，康乐卫士公司总经理/董事，研究员职称，享受国务院政府特殊津贴、“首都劳动奖章”获得者，入选 “新创工程-亦麒麟”人才；曾获国家科技进步三等奖1项，省部级科技进步奖二等奖2项、三等奖1项。（1）主持“国家科技重大专项”子课题1项，北京市重大科技计划课题2项，开发区科技创新专项资金项目2项，均按期完成课题计划任务，取得相应技术成果。（2）主持HPV16、18、58型三价疫苗研究，目前正在开展III期临床试验；（3）主持HPV九价疫苗研究，目前正在开展III期临床研究。（4）主持HPV15价疫苗的临床前研究，并获得临床批件。（5）在MOL BIOSYST、Papillomavirus Research等杂志发表HPV疫苗相关论文8篇，申请38项发明专利，其中29项专利授权。Yongjiang Liu is the general manager/director, professor, expert of special allowances of the State Council and winner of the "Capital Labor Medal". He presided over the completion of preclinical research of HPV16, 18, 58 type trivalent vaccines, and obtained clinical trial approvals, and is currently conducting phase III clinical trials; He presided over the completion of the pre-clinical study of the HPV nine-valent vaccine, and received clinical trial approvals.  He is currently conducting a phase III clinical trial of the HPV nine-valent vaccine. He presided over the completion of the pre-clinical study of the HPV 15-valent vaccine, and received clinical trial approvals. He published 8 papers related to HPV vaccines in MOL BIOSYST, Papillomavirus Research and other magazines, applying for 38 invention patents, including 29 patent authorizations. 彭育才 博士 创始人丽凡达生物 回爱民 博士 总经理Sharpsight Biopharma Consulting更多发言嘉宾持续更新中...大会亮点历届杰出发言人历届会议精彩瞬间（点击图片了解上届峰会详情）（扫码报名）（微信报名）还可邀您加入行业交流群和同行一起交流互动【媒体合作/咨询参会/赞助合作】Aili LI 李先生Tel: (86 21) 6095 7201/13849919680E-mail: aili.li@shine-consultant.com更多生物医药系列峰会点击抢先了解✦ END

Fourth-Quarter and Full-Year 2022 Results Reflect Sustained Strong Revenue Growth Fourth-Quarter 2022 Worldwide Sales Were $13.8 Billion, an Increase of 2% From Fourth Quarter 2021; Growth Excluding the Impact of Foreign Exchange Was 8% Fourth-Quarter 2022 GAAP EPS From Continuing Operations Was $1.18; Fourth-Quarter 2022 Non-GAAP EPS Was $1.62 Full-Year 2022 Worldwide Sales Were $59.3 Billion, an Increase of 22% From Full Year 2021; Growth Excluding LAGEVRIO Was 12%; Growth Excluding LAGEVRIO and the Impact of Foreign Exchange Was 15% KEYTRUDA Sales Grew 22% to $20.9 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 27% GARDASIL/GARDASIL 9 Sales Grew 22% to $6.9 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 27% Full-Year 2022 GAAP EPS From Continuing Operations Was $5.71; Full-Year 2022 Non-GAAP EPS Was $7.48 In 2022, Augmented Pipeline Through Strategic Business Development, Including Acquisition of Imago and Key Agreements With Moderna, Orna, Orion and Kelun-Biotech 2023 Financial Outlook Anticipates Full-Year 2023 Worldwide Sales To Be Between $57.2 Billion and $58.7 Billion; Outlook Includes Approximately $1.0 Billion of LAGEVRIO Sales Expects Full-Year 2023 GAAP EPS To Be Between $5.86 and $6.01; Expects Non-GAAP EPS To Be Between $6.80 and $6.95 RAHWAY, N.J.--(BUSINESS WIRE)-- Merck & Co. (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2022. "2022 was an exceptional year for Merck, which is a testament to the profound impact our medicines and vaccines are having on patients globally," said Robert M. Davis, chairman and chief executive officer. “I am extremely proud of what our talented and dedicated colleagues have accomplished scientifically, commercially and operationally. Our science-led strategy is working as we continue to build a sustainable engine that will drive innovation and generate long-term value for patients and shareholders well into the next decade.” Financial Summary Financial information presented in this release reflects Merck’s results on a continuing operations basis, which excludes Organon & Co. that was spun off in 2021. $ in millions, except EPS amounts Fourth Quarter Year Ended 2022 2021 Change Change Ex-Exchange Dec. 31, 2022 Dec. 31, 2021 Change Change Ex-Exchange Sales $13,830 $13,521 2% 8% $59,283 $48,704 22% 26% GAAP net income1 3,017 3,820 -21% -17% 14,519 12,345 18% 21% Non-GAAP net income that excludes certain items1,2* 4,129 4,592 -10% -7% 19,005 13,623 40% 43% GAAP EPS 1.18 1.51 -22% -17% 5.71 4.86 17% 21% Non-GAAP EPS that excludes certain items2* 1.62 1.81 -10% -7% 7.48 5.37 39% 43% *Refer to table on page 11. Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $1.18 for the fourth quarter and $5.71 for the full year of 2022. Non-GAAP EPS was $1.62 for the fourth quarter and $7.48 for the full year of 2022. The declines in GAAP and non-GAAP EPS in the fourth quarter versus the prior year were primarily due to lower fourth quarter 2021 effective tax rates and the unfavorable impact of foreign exchange, partially offset by strong underlying business performance. The GAAP EPS decline in the fourth quarter also reflects the unfavorable impact of losses from investments in equity securities compared with gains in the prior year. Full-year 2022 and 2021 GAAP and non-GAAP EPS were negatively impacted by $0.22 and $0.65, respectively, related to an asset acquisition, and collaboration and licensing agreements. Non-GAAP EPS excludes acquisition- and divestiture-related costs (including pretax intangible asset impairment research and development [R&D] charges of $780 million and $1.7 billion in the fourth quarter and full year of 2022, respectively, largely related to nemtabrutinib) and restructuring costs, as well as income and losses from investments in equity securities. In 2022, the company changed the treatment of certain items for purposes of its non-GAAP reporting. Results for 2021 have been recast to conform to the new presentation. For more information, refer to the Form 8-K filed by the company on April 21, 2022. Oncology Program Highlights Merck announced the following regulatory and clinical milestones for KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy: KEYTRUDA approved by the U.S. Food and Drug Administration (FDA) as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 centimeters), II, or IIIA non-small cell lung cancer (NSCLC), based on the pivotal Phase 3 KEYNOTE-091 trial. In collaboration with Moderna, Inc. (Moderna), positive topline results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial, which showed that KEYTRUDA in combination with mRNA-4157/V940, an investigational personalized mRNA therapeutic cancer vaccine, demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of recurrence-free survival versus KEYTRUDA alone for the adjuvant treatment of patients with stage III/IV melanoma following complete resection. In collaboration with Seagen Inc. and Astellas Pharma Inc., acceptance by the FDA for priority review of the supplemental Biologics License Application for KEYTRUDA in combination with Padcev®3 (enfortumab vedotin-ejfv) for the treatment of patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy. Positive topline results from the pivotal Phase 3 KEYNOTE-859 trial investigating KEYTRUDA in combination with chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Positive topline results from the Phase 3 KEYNOTE-966 trial investigating KEYTRUDA in combination with standard of care chemotherapy (gemcitabine and cisplatin) for the first-line treatment of patients with advanced or unresectable biliary tract cancer. Merck announced that Lynparza (olaparib), an oral PARP inhibitor being co-developed and co-commercialized with AstraZeneca, was approved in the European Union (EU) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated, based on the Phase 3 PROpel trial. Vaccine Program Highlights Merck announced that an updated systematic literature review of 138 peer-reviewed studies observed that use of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] led to reductions in the rates of high-grade (precancerous) and low-grade cervical lesions, as well as reductions in certain non-cervical HPV-related diseases and HPV infection in women and men. Cardiovascular Program Highlights Merck will present results from the Phase 3 STELLAR study evaluating investigational sotatercept for the treatment of patients with pulmonary arterial hypertension, and from the Phase 2 study evaluating MK-0616, the company’s investigational oral macrocyclic peptide PCSK9 inhibitor for the treatment of patients with hypercholesterolemia, at the American College of Cardiology’s 72nd Annual Scientific Session together with the World Heart Federation’s World Congress of Cardiology (ACC.23/WCC). Merck will host an investor event at ACC.23/WCC on March 6, 2023, to discuss these results. Further details will be announced at a later date. Business Development Highlights Merck announced and successfully completed the acquisition of Imago BioSciences, Inc. (Imago), for an approximate total equity value of $1.35 billion, expanding Merck’s growing hematology portfolio. Merck announced that it has expanded its relationship and entered into an exclusive license and collaboration agreement with Kelun-Biotech (a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd) to develop up to seven investigational preclinical antibody-drug conjugates (ADCs) for the treatment of cancer. Environmental, Social and Governance (ESG) Updates Merck was named one of America’s most JUST companies by JUST Capital and CNBC, ranking No. 1 in the pharmaceuticals and biotech industry for the third straight year and No. 26 overall of all companies named. Merck published its Sustainability Bond Allocation Report, which highlighted how the company’s initial $1.0 billion sustainability bond is helping to drive progress across ESG focus areas. Fourth-Quarter and Full-Year Revenue Performance The following table reflects sales of the company’s top pharmaceutical products, as well as sales of Animal Health products. $ in millions Fourth Quarter Year Ended 2022 2021 Change Change Ex-Exchange Dec. 31, 2022 Dec. 31, 2021 Change Change Ex-Exchange Total Sales $13,830 $13,521 2% 8% $59,283 $48,704 22% 26% Pharmaceutical 12,180 12,039 1% 9% 52,005 42,754 22% 28% KEYTRUDA 5,450 4,577 19% 26% 20,937 17,186 22% 27% GARDASIL / GARDASIL 9 1,470 1,528 -4% 6% 6,897 5,673 22% 27% LAGEVRIO 825 952 -13% 2% 5,684 952 *** *** JANUVIA / JANUMET 913 1,393 -34% -29% 4,513 5,288 -15% -9% PROQUAD, M-M-R II and VARIVAX 526 509 3% 6% 2,241 2,135 5% 7% BRIDION 441 436 1% 7% 1,685 1,532 10% 16% Lynparza* 292 268 9% 14% 1,116 989 13% 18% Lenvima* 216 206 5% 9% 876 704 24% 28% ROTATEQ 139 213 -35% -31% 783 807 -3% 0% SIMPONI 166 206 -19% -8% 706 825 -14% -4% Animal Health 1,230 1,261 -2% 6% 5,550 5,568 0% 6% Livestock 814 791 3% 12% 3,300 3,295 0% 7% Companion Animals 416 470 -11% -5% 2,250 2,273 -1% 4% Other Revenues** 420 221 90% -25% 1,728 382 *** 87% *Alliance revenue for this product represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs. **Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. ***>100% Pharmaceutical Revenue Fourth-quarter pharmaceutical sales grew 1% to $12.2 billion. Excluding the unfavorable impact of foreign exchange, pharmaceutical sales grew 9%, primarily driven by oncology and hospital acute care, partially offset by diabetes. Growth in oncology was largely driven by higher sales of KEYTRUDA, which rose 19% to $5.5 billion in the quarter. Global sales growth of KEYTRUDA reflects continued strong momentum from metastatic indications including certain types of NSCLC, renal cell carcinoma, head and neck squamous cell carcinoma, triple-negative breast cancer (TNBC) and microsatellite instability-high (MSI-H) cancers, and increased uptake across recent earlier-stage launches, including certain types of neoadjuvant/adjuvant TNBC in the U.S. Also contributing to growth in oncology was increased alliance revenue from Lynparza, which grew 9% to $292 million, driven primarily by higher demand in the U.S. In addition, sales of WELIREG (belzutifan), an oral hypoxia-inducible factor-2 alpha inhibitor, increased to $40 million due to continued uptake in the U.S. following the product’s launch in 2021. Growth in hospital acute care reflects higher sales of ZERBAXA (ceftolozane and tazobactam), a combination cephalosporin antibacterial and beta-lactamase inhibitor for the treatment of patients with certain bacterial infections. ZERBAXA sales of $49 million in the fourth quarter of 2022 increased from $10 million in the fourth quarter of 2021, reflecting uptake from the completion of the phased resupply in 2022 that was initiated in the fourth quarter of 2021. Growth in hospital acute care also reflects higher sales of PREVYMIS (letermovir), a medicine for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogenic hematopoietic stem cell transplant, which increased 17% to $118 million, reflecting higher demand globally. Vaccines sales performance reflects lower combined sales of GARDASIL and GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), vaccines to prevent certain cancers and other diseases caused by HPV, which declined 4% to $1.5 billion. Excluding the unfavorable impact of foreign exchange, GARDASIL/GARDASIL 9 sales grew 6%, reflecting higher demand outside of the U.S., particularly in China. Vaccines sales performance also reflects lower sales of PNEUMOVAX 23 (pneumococcal vaccine polyvalent), a vaccine to help prevent pneumococcal disease, which declined 50% to $145 million, primarily reflecting lower U.S. demand as the market continues to shift toward newer adult pneumococcal conjugate vaccines. In addition, sales of ROTATEQ (Rotavirus Vaccine, Live Oral, Pentavalent), a vaccine to help protect against rotavirus gastroenteritis in infants and children, declined 35% to $139 million, primarily due to lower sales in China, which benefited in the fourth quarter of 2021 from increased supply, and lower sales in the U.S. largely due to the timing of public-sector purchases. Vaccines sales performance benefited from the ongoing pediatric launch of VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine), a vaccine to help prevent invasive pneumococcal disease, which had sales of $138 million, largely due to inventory stocking in the U.S. Pharmaceutical sales growth was partially offset by lower combined sales of JANUVIA (sitagliptin) and JANUMET (sitagliptin and metformin HCI), for the treatment of type 2 diabetes, which declined 34% to $913 million, primarily reflecting generic competition in certain international markets, particularly in Europe and the Asia Pacific region, and lower demand and net pricing in the U.S. Sales of LAGEVRIO (molnupiravir), an investigational oral antiviral COVID-19 medicine, decreased 13% to $825 million. Excluding the unfavorable impact of foreign exchange, sales increased 2%, primarily driven by strong growth in Japan and the U.K. and the launch in Australia, offset by a decline in the U.S. Full-year 2022 pharmaceutical sales grew 22% to $52.0 billion. Pharmaceutical sales growth was 16% excluding LAGEVRIO and the unfavorable impact of foreign exchange, primarily driven by higher sales in oncology, particularly KEYTRUDA, higher sales of vaccines, reflecting strong growth of GARDASIL/GARDASIL 9 and the ongoing pediatric launch of VAXNEUVANCE, as well as growth in hospital acute care products, including ZERBAXA and BRIDION (sugammadex) injection 100 mg/mL, a medicine for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults and pediatric patients ages 2 years and older undergoing surgery. Pharmaceutical sales growth in 2022 was partially offset by lower sales of JANUVIA and JANUMET, primarily reflecting lower demand in Europe as a result of generic competition, and a decline in PNEUMOVAX 23 sales as the U.S. market continues to shift toward newer adult pneumococcal conjugate vaccines. COVID-19-related disruptions negatively affected sales in 2022, but to a lesser extent than in 2021, which benefited year-over-year sales growth. Animal Health Revenue Animal Health sales totaled $1.2 billion for the fourth quarter of 2022, a 2% decline compared with the fourth quarter of 2021. Excluding the unfavorable effect of foreign exchange, Animal Health sales increased 6%. Sales growth of livestock products reflects higher demand, notably in the ruminant and poultry product portfolio, which includes technology solutions products, as well as higher pricing. Sales of companion animal products were negatively impacted by a reduction in veterinary visits in the broader companion animal market following the more favorable trend during the pandemic, as well as supply constraints for certain vaccines, partially offset by higher pricing. Full-year 2022 Animal Health sales were $5.5 billion, in line with the prior year. Excluding the unfavorable effect of foreign exchange, Animal Health sales grew 6%, primarily due to higher pricing. Full-year sales growth was also driven by higher demand of livestock products, led by ruminant, poultry and swine products. Sales of companion animal products also reflect higher demand for the BRAVECTO (fluralaner) parasiticide line of products, which had sales of $1.0 billion, partially offset by supply constraints for certain vaccines. Fourth-Quarter and Full-Year Expense, EPS and Related Information The tables below present selected expense information. $ in millions Fourth Quarter 2022 GAAP Acquisition- and Divestiture- Related Costs4 Restructuring Costs (Income) Loss From Investments in Equity Securities Certain Other Items Non- GAAP2 Cost of sales $3,881 $482 $38 $- $- $3,361 Selling, general and administrative 2,687 39 20 - - 2,628 Research and development 3,775 740 - - - 3,035 Restructuring costs 49 - 49 - - - Other (income) expense, net (75) (69) - 80 - (86) Fourth Quarter 2021 Cost of sales $3,873 $419 $47 $- $(4) $3,411 Selling, general and administrative 2,830 226 10 - - 2,594 Research and development 3,068 397 7 - - 2,664 Restructuring costs 174 - 174 - - - Other (income) expense, net (333) (3) - (381) - 51 $ in millions Year Ended Dec. 31, 2022 GAAP Acquisition- and Divestiture- Related Costs4 Restructuring Costs (Income) Loss From Investments in Equity Securities Certain Other Items Non- GAAP2 Cost of sales $17,411 $2,059 $205 $- $- $15,147 Selling, general and administrative 10,042 176 94 - - 9,772 Research and development 13,548 1,676 30 - - 11,842 Restructuring costs 337 - 337 - - - Other (income) expense, net 1,501 (207) - 1,348 - 360 Year Ended Dec. 31, 2021 Cost of sales $13,626 $1,607 $160 $- $221 $11,638 Selling, general and administrative 9,634 322 19 - - 9,293 Research and development 12,245 479 28 - - 11,738 Restructuring costs 661 - 661 - - - Other (income) expense, net (1,341) 76 - (1,884) - 467 GAAP Expense, EPS and Related Information Gross margin was 71.9% for the fourth quarter of 2022 compared with 71.4% for the fourth quarter of 2021. The increase primarily reflects favorable product mix and foreign exchange. Gross margin was 70.6% for the full year of 2022 compared to 72.0% for the full year of 2021. The decline primarily reflects the unfavorable impacts of higher amortization of intangible assets, as well as higher revenue from third-party manufacturing arrangements and sales of LAGEVRIO, both of which have lower gross margins. The full-year gross margin decline was partially offset by the favorable effects of product mix, foreign exchange and charges in the prior year related to the discontinuation of COVID-19 development programs. Selling, general and administrative (SG&A) expenses were $2.7 billion in the fourth quarter of 2022, a decrease of 5% compared to the fourth quarter of 2021. The decrease primarily reflects lower acquisition- and divestiture-related costs and the favorable effect of foreign exchange, partially offset by higher promotional spending, as well as higher administrative costs. Full-year SG&A expenses were $10.0 billion, an increase of 4% compared to the full year of 2021. The increase primarily reflects higher administrative costs, as well as higher promotional spending, partially offset by the favorable impact of foreign exchange and lower acquisition- and divestiture-related costs. R&D expenses were $3.8 billion in the fourth quarter of 2022, an increase of 23% compared to the fourth quarter of 2021. The increase was primarily driven by higher intangible asset impairment charges related to nemtabrutinib, which were $780 million in the fourth quarter of 2022 compared with $275 million in the fourth quarter of 2021, lower reimbursement of LAGEVRIO R&D costs from Ridgeback Biotherapeutics (Ridgeback), higher compensation and benefit costs reflecting in part increased headcount to support expanded clinical development activity, and higher clinical development spending. R&D expenses were $13.5 billion for the full year of 2022, an increase of 11% compared with the full year of 2021. The increase was primarily driven by higher intangible asset impairment charges, which were $1.7 billion in 2022 compared with $275 million in 2021, largely related to nemtabrutinib, $690 million of charges in 2022 related to collaboration and licensing agreements with Moderna, Orna Therapeutics (Orna) and Orion Corporation (Orion), as well as higher compensation and benefit costs and clinical development spending. The increase was partially offset by a $1.7 billion charge in the prior year for the acquisition of Pandion Therapeutics, Inc. (Pandion). Other (income) expense, net, was $75 million of income in the fourth quarter of 2022 compared to $333 million of income in the fourth quarter of 2021. Other (income) expense, net, was $1.5 billion of expense in the full year of 2022 compared to $1.3 billion of income in the full year of 2021. The change in both periods is primarily due to net losses from investments in equity securities in 2022 compared with net gains from investments in equity securities in 2021. The effective tax rate for the fourth quarter of 2022 of 14.1% reflects the unfavorable impact of a higher than anticipated full-year rate of 11.7% due to a less favorable mix of income and expense than previously anticipated, while the effective tax rate for the fourth quarter of 2021 of 2.2% reflects the favorable impact of a lower than previously expected full-year 2021 rate of 11.0%. GAAP EPS was $1.18 for the fourth quarter of 2022 compared to $1.51 for the fourth quarter of 2021. GAAP EPS was $5.71 for the full year of 2022 compared to $4.86 for the full year of 2021. Non-GAAP Expense, EPS and Related Information Non-GAAP gross margin was 75.7% for the fourth quarter of 2022 compared to 74.8% for the fourth quarter of 2021. The increase primarily reflects the favorable effects of product mix and foreign exchange. Non-GAAP gross margin was 74.4% for the full year of 2022 compared to 76.1% for the full year of 2021. The decrease primarily reflects the impact of higher revenue from third-party manufacturing arrangements and sales of LAGEVRIO, both of which have lower gross margins, partially offset by the favorable effects of product mix and foreign exchange. Non-GAAP SG&A expenses were $2.6 billion in the fourth quarter of 2022, an increase of 1% compared to the fourth quarter of 2021. Non-GAAP SG&A expenses for the full year were $9.8 billion, an increase of 5% compared to the full year of 2021. The increase in both periods primarily reflects higher administrative costs, as well as higher promotional spending, partially offset by the favorable impact of foreign exchange. Non-GAAP R&D expenses were $3.0 billion in the fourth quarter of 2022, an increase of 14% compared with the fourth quarter of 2021. The increase was primarily driven by lower reimbursement of LAGEVRIO R&D costs from Ridgeback, higher compensation and benefit costs reflecting in part increased headcount to support expanded clinical development activity, and higher clinical development spending. Non-GAAP R&D expenses were $11.8 billion for the full year of 2022, an increase of 1% compared with the full year of 2021. The increase was primarily driven by $690 million of charges in 2022 related to collaboration and licensing agreements with Moderna, Orna and Orion, as well as higher compensation and benefit costs and clinical development spending. The increase was partially offset by a $1.7 billion charge in the prior year for the acquisition of Pandion. Non-GAAP other (income) expense, net, was $86 million of income in the fourth quarter of 2022 compared to $51 million of expense in the fourth quarter of 2021. Non-GAAP other (income) expense, net, was $360 million of expense in the full year of 2022 compared to $467 million of expense in the full year of 2021. The non-GAAP effective tax rate for the fourth quarter of 2022 of 15.6% reflects the unfavorable impact of a higher than anticipated full-year rate of 14.2% due to a less favorable mix of income and expense than previously anticipated, while the non-GAAP effective tax rate for the fourth quarter of 2021 of 4.3% reflects the favorable impact of a lower than previously expected full-year 2021 rate of 12.4%. Non-GAAP EPS was $1.62 for the fourth quarter of 2022 compared to $1.81 for the fourth quarter of 2021. Non-GAAP EPS was $7.48 for the full year of 2022 compared to $5.37 for the full year of 2021. A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows. $ in millions, except EPS amounts Fourth Quarter Year Ended 2022 2021 Dec. 31, 2022 Dec. 31, 2021 EPS GAAP EPS $1.18 $1.51 $5.71 $4.86 Difference 0.44 0.30 1.77 0.51 Non-GAAP EPS that excludes items listed below2 $1.62 $1.81 $7.48 $5.37 Net Income GAAP net income1 $3,017 $3,820 $14,519 $12,345 Difference 1,112 772 4,486 1,278 Non-GAAP net income that excludes items listed below1,2 $4,129 $4,592 $19,005 $13,623 Decrease (Increase) in Net Income Due to Excluded Items: Acquisition- and divestiture-related costs4 $1,192 $1,039 $3,704 $2,484 Restructuring costs 107 238 666 868 Loss (income) from investments in equity securities 80 (381) 1,348 (1,884) Charges for the discontinuation of COVID-19 development programs - - - 221 Other - (4) - - Net decrease (increase) in income before taxes 1,379 892 5,718 1,689 Income tax (benefit) expense5 (267) (120) (1,232) (411) Decrease (increase) in net income $1,112 $772 $4,486 $1,278 Financial Outlook The following table summarizes the company’s full-year 2023 financial guidance. GAAP Non-GAAP2 Revenue* $57.2 to $58.7 billion $57.2 to $58.7 billion Gross margin Approximately 73% Approximately 77% Operating expenses** $23.3 to $24.3 billion $23.1 to $24.1 billion Effective tax rate 17% to 18% 17% to 18% EPS*** $5.86 to $6.01 $6.80 to $6.95 *Includes approximately $1.0 billion of LAGEVRIO sales. The company does not have any non-GAAP adjustments to revenue. **Includes an aggregate $1.4 billion of R&D expenses related to the Imago acquisition and upfront payment for a license and collaboration agreement with Kelun-Biotech. ***Includes $0.53 of charges related to the Imago acquisition and upfront payment to Kelun-Biotech. EPS guidance for 2023 assumes a share count (assuming dilution) of approximately 2.55 billion shares. Merck anticipates full-year 2023 revenue to be between $57.2 billion and $58.7 billion, including a negative impact of foreign exchange of approximately 2% at mid-January 2023 exchange rates. The company expects a significant decline in sales of LAGEVRIO, which are expected to be approximately $1.0 billion. Merck expects full-year 2023 GAAP EPS to be between $5.86 and $6.01. Merck expects full-year 2023 non-GAAP EPS to be between $6.80 and $6.95, including a negative impact of foreign exchange of approximately 4%. The non-GAAP range excludes acquisition- and divestiture-related costs, costs related to restructuring programs, as well as income and losses from investment in equity securities. In the fourth quarter of 2022, Merck announced the acquisition of Imago for an approximate total value of $1.35 billion and a license and collaboration agreement with Kelun-Biotech, which includes an upfront payment of $175 million. The Imago acquisition closed in January 2023 and the collaboration with Kelun-Biotech is expected to close in the first quarter of 2023, resulting in the inclusion of an aggregate $1.4 billion of R&D expenses in Merck’s GAAP and non-GAAP results for the first quarter and full year of 2023. The Imago acquisition is also anticipated to result in an approximate 1 percentage point unfavorable impact to Merck’s expected full-year 2023 GAAP and non-GAAP tax rates. The impact of these two transactions on expected full-year 2023 GAAP and non-GAAP EPS is approximately $0.53. GAAP and non-GAAP EPS in 2022 were negatively impacted by $0.22 of charges related to the collaboration and licensing agreements with Moderna, Orna and Orion. Operating expenses include incremental R&D spending to advance the development of the Imago and Kelun-Biotech programs, as well as other promising programs related to the collaboration and licensing agreements with Moderna, Orna and Orion. The financial outlook does not assume additional significant potential business development transactions. A reconciliation of anticipated 2023 GAAP EPS to non-GAAP EPS and the items excluded from non-GAAP EPS are provided in the table below. $ in millions, except EPS amounts Full Year 2023 GAAP EPS $5.86 to $6.01 Difference $0.94 Non-GAAP EPS that excludes items listed below2 $6.80 to $6.95 Acquisition- and divestiture-related costs $2,500 Restructuring costs 400 (Income) loss from investments in equity securities (20) Net decrease (increase) in income before taxes $2,880 Estimated income tax (benefit) expense (480) Decrease (increase) in net income $2,400 Earnings Conference Call Investors, journalists and the general public may access a live audio webcast of the earnings conference call on Thursday, Feb. 2, at 8:00 a.m. ET via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and slides highlighting the results, will be available at . All participants may join the call by dialing (888) 769-8514 (U.S. Toll-Free) or (517) 308-9208 (International) and using the access code 8206435. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2021, and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( ). 1 Net income from continuing operations attributable to Merck & Co., Inc. 2 Merck is providing certain 2022 and 2021 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s results because management uses non-GAAP results to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. In addition, senior management’s annual compensation is derived in part using a non-GAAP pre-tax income metric. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of the non-GAAP adjustments, see Table 2a attached to this release. Non-GAAP results for 2021 have been recast to conform to presentation changes implemented in 2022. 3 Registered trademark of Seagen and Agensys. 4 Includes expenses for the amortization of intangible assets and purchase accounting adjustments to inventories recognized as a result of acquisitions, intangible asset impairment charges and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. R&D expenses include intangible asset impairment charges of $780 million and $1.7 billion in fourth quarter and full year 2022, respectively, and $275 million in both fourth quarter and full year 2021, largely related to nemtabrutinib, which was obtained as part of the 2020 acquisition of ArQule, Inc. Also includes integration, transaction and certain other costs related to acquisitions and divestitures. 5 Includes the estimated tax impact on the reconciling items. In addition, the amount for full-year 2021 includes a $207 million net tax benefit related to the settlement of certain federal income tax matters. MERCK & CO., INC. CONSOLIDATED STATEMENT OF INCOME - GAAP (AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES) (UNAUDITED) Table 1 On June 2, 2021, Merck completed the spinoff of products from its women’s health, biosimilars and established brands businesses into a new, independent, publicly traded company named Organon & Co. (Organon). The historical results of the businesses that were contributed to Organon in the spin-off are excluded from sales and expenses below and reflected as discontinued operations in the company’s Consolidated Statements of Income provided below. GAAP % Change GAAP % Change 4Q22 4Q21 Full Year 2022 Full Year 2021 Sales $ 13,830 $ 13,521 2 % $ 59,283 $ 48,704 22 % Costs, Expenses and Other Cost of sales 3,881 3,873 0 % 17,411 13,626 28 % Selling, general and administrative 2,687 2,830 -5 % 10,042 9,634 4 % Research and development 3,775 3,068 23 % 13,548 12,245 11 % Restructuring costs 49 174 -72 % 337 661 -49 % Other (income) expense, net (75 ) (333 ) -77 % 1,501 (1,341 ) * Income from Continuing Operations Before Taxes 3,513 3,909 -10 % 16,444 13,879 18 % Income Tax Provision 495 85 1,918 1,521 Net Income from Continuing Operations 3,018 3,824 -21 % 14,526 12,358 18 % Less: Net Income Attributable to Noncontrolling Interests 1 4 7 13 Net Income from Continuing Operations Attributable to Merck & Co., Inc. 3,017 3,820 -21 % 14,519 12,345 18 % (Loss) Income from Discontinued Operations, Net of Taxes and Amounts Attributable to Noncontrolling Interests - (62 ) * - 704 * Net Income Attributable to Merck & Co., Inc. $ 3,017 $ 3,758 -20 % $ 14,519 $ 13,049 11 % Basic Earnings (Loss) per Common Share Attributable to Merck & Co., Inc. Common Shareholders: Income from Continuing Operations $ 1.19 $ 1.51 -21 % $ 5.73 $ 4.88 17 % (Loss) Income from Discontinued Operations - (0.02 ) * - 0.28 * Net Income $ 1.19 $ 1.49 -20 % $ 5.73 $ 5.16 11 % Earnings (Loss) per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders: Income from Continuing Operations $ 1.18 $ 1.51 -22 % $ 5.71 $ 4.86 17 % (Loss) Income from Discontinued Operations - (0.02 ) * - 0.28 * Net Income $ 1.18 $ 1.48 -20 % $ 5.71 $ 5.14 11 % Average Shares Outstanding 2,536 2,527 2,532 2,530 Average Shares Outstanding Assuming Dilution 2,548 2,535 2,542 2,538 Tax Rate from Continuing Operations 14.1 % 2.2 % 11.7 % 11.0 % * 100% or greater MERCK & CO., INC. FOURTH QUARTER AND FULL YEAR 2022 GAAP TO NON-GAAP RECONCILIATION - CONTINUING OPERATIONS (AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES) (UNAUDITED) Table 2a GAAP Acquisition and Divestiture- Related Costs (1) Restructuring Costs (2) (Income) Loss from Investments in Equity Securities Adjustment Subtotal Non-GAAP Fourth Quarter Cost of sales $ 3,881 482 38 520 $ 3,361 Selling, general and administrative 2,687 39 20 59 2,628 Research and development 3,775 740 740 3,035 Restructuring costs 49 49 49 - Other (income) expense, net (75 ) (69 ) 80 11 (86 ) Income from Continuing Operations Before Taxes 3,513 (1,192 ) (107 ) (80 ) (1,379 ) 4,892 Income Tax Provision (Benefit) 495 (222 ) (3) (32 ) (3) (13 ) (3) (267 ) 762 Net Income from Continuing Operations 3,018 (970 ) (75 ) (67 ) (1,112 ) 4,130 Net Income from Continuing Operations Attributable to Merck & Co., Inc. 3,017 (970 ) (75 ) (67 ) (1,112 ) 4,129 Earnings per Common Share Assuming Dilution from Continuing Operations $ 1.18 (0.38 ) (0.03 ) (0.03 ) (0.44 ) $ 1.62 Tax Rate 14.1 % 15.6 % Full Year Cost of sales $ 17,411 2,059 205 2,264 $ 15,147 Selling, general and administrative 10,042 176 94 270 9,772 Research and development 13,548 1,676 30 1,706 11,842 Restructuring costs 337 337 337 - Other (income) expense, net 1,501 (207 ) 1,348 1,141 360 Income from Continuing Operations Before Taxes 16,444 (3,704 ) (666 ) (1,348 ) (5,718 ) 22,162 Income Tax Provision (Benefit) 1,918 (809 ) (3) (129 ) (3) (294 ) (3) (1,232 ) 3,150 Net Income from Continuing Operations 14,526 (2,895 ) (537 ) (1,054 ) (4,486 ) 19,012 Net Income from Continuing Operations Attributable to Merck & Co., Inc. 14,519 (2,895 ) (537 ) (1,054 ) (4,486 ) 19,005 Earnings per Common Share Assuming Dilution from Continuing Operations $ 5.71 (1.14 ) (0.21 ) (0.42 ) (1.77 ) $ 7.48 Tax Rate 11.7 % 14.2 % Only the line items that are affected by non-GAAP adjustments are shown. Merck is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing non-GAAP information enhances investors’ understanding of the company’s results because management uses non-GAAP measures to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. In addition, senior management’s annual compensation is derived in part using a non-GAAP pretax income metric. The non-GAAP information presented should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. (1) Amounts included in cost of sales primarily reflect expenses for the amortization of intangible assets. Amounts included in selling, general and administrative expenses reflect integration, transaction and certain other costs related to acquisitions and divestitures. Amounts included in research and development expenses for the fourth quarter and full year primarily reflect $780 million and $1.7 billion, respectively, of intangible asset impairment charges largely related to nemtabrutinib, which was obtained as part of the 2020 ArQule, Inc. acquisition, and expenses for the amortization of intangible assets, partially offset by a reduction in expenses related to changes in the estimated fair value of liabilities for contingent consideration. Amounts included in other (income) expense, net, for the fourth quarter and full year reflect royalty income and decreases in the estimated fair value measurement of liabilities for contingent consideration related to the prior termination of the Sanofi-Pasteur MSD joint venture. (2) Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to activities under the company's formal restructuring programs. (3) Represents the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments. MERCK & CO., INC. FRANCHISE / KEY PRODUCT SALES - CONTINUING OPERATIONS (AMOUNTS IN MILLIONS) (UNAUDITED) Table 3 2022 2021 4Q Full Year 1Q 2Q 3Q 4Q Full Year 1Q 2Q 3Q 4Q Full Year Nom % Ex-Exch % Nom % Ex-Exch % TOTAL SALES (1) $15,901 $14,593 $14,959 $13,830 $59,283 $10,627 $11,402 $13,154 $13,521 $48,704 2 8 22 26 PHARMACEUTICAL 14,107 12,756 12,963 12,180 52,005 9,238 9,980 11,496 12,039 42,754 1 9 22 28 Oncology Keytruda 4,809 5,252 5,426 5,450 20,937 3,899 4,176 4,534 4,577 17,186 19 26 22 27 Alliance Revenue – Lynparza (2) 266 275 284 292 1,116 228 248 246 268 989 9 14 13 18 Alliance Revenue – Lenvima (2) 227 231 202 216 876 130 181 188 206 704 5 9 24 28 Alliance Revenue – Reblozyl (3) 52 33 39 41 166 17 17 145 145 * * Vaccines (4) Gardasil / Gardasil 9 1,460 1,674 2,294 1,470 6,897 917 1,234 1,993 1,528 5,673 -4 6 22 27 ProQuad / M-M-R II / Varivax 470 578 668 526 2,241 449 516 661 509 2,135 3 6 5 7 RotaTeq 216 173 256 139 783 158 208 227 213 807 -35 -31 -3 0 Pneumovax 23 173 153 131 145 602 171 152 277 292 893 -50 -47 -33 -30 Vaqta 36 35 64 39 173 34 56 48 41 179 -5 -2 -3 -2 Hospital Acute Care Bridion 395 426 423 441 1,685 340 387 369 436 1,532 1 7 10 16 Prevymis 94 103 114 118 428 82 93 96 100 370 17 28 16 24 Dificid 52 66 77 67 263 27 34 54 60 175 12 12 50 50 Primaxin 58 64 63 54 239 65 60 70 65 259 -17 -7 -8 -4 Noxafil 57 60 62 58 238 67 66 64 62 259 -5 7 -8 -1 Invanz 52 46 50 40 189 57 48 53 45 202 -10 -2 -7 -1 Cancidas 53 42 43 36 174 57 54 56 45 212 -19 -10 -18 -14 Zerbaxa 30 46 43 49 169 (8) (1) (2) 10 (1) * * * * Cardiovascular Alliance Revenue - Adempas/Verquvo (5) 72 98 88 82 341 74 74 100 94 342 -12 -12 - - Adempas (6) 61 63 57 57 238 55 74 59 63 252 -10 6 -6 7 Virology Lagevrio 3,247 1,177 436 825 5,684 952 952 -13 2 * * Isentress / Isentress HD 158 147 161 167 633 209 192 189 178 769 -7 -1 -18 -13 Neuroscience Belsomra 69 69 62 59 258 79 78 81 80 318 -27 -14 -19 -9 Immunology Simponi 186 181 173 166 706 214 202 203 206 825 -19 -8 -14 -4 Remicade 61 53 49 44 207 85 75 73 67 299 -34 -22 -31 -21 Diabetes (7) Januvia 779 756 717 561 2,813 809 784 852 878 3,324 -36 -31 -15 -11 Janumet 454 476 417 353 1,700 486 477 487 514 1,964 -31 -25 -13 -7 Other Pharmaceutical (8) 520 479 564 685 2,249 554 512 518 533 2,118 29 37 6 12 ANIMAL HEALTH 1,482 1,467 1,371 1,230 5,550 1,418 1,472 1,417 1,261 5,568 -2 6 - 6 Livestock 832 826 829 814 3,300 819 821 864 791 3,295 3 12 - 7 Companion Animals 650 641 542 416 2,250 599 651 553 470 2,273 -11 -5 -1 4 Other Revenues (9) 312 370 625 420 1,728 (29) (50) 241 221 382 90 -25 * 87 * 200% or greater Sum of quarterly amounts may not equal year-to-date amounts due to rounding. (1) Only select products are shown. (2) Alliance Revenue represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs. (3) Alliance Revenue represents royalties and a milestone payment. (4) Total Vaccines sales were $2,481 million, $2,709 million, $3,552 million and $2,554 million in the first, second, third and fourth quarter of 2022, respectively, and $1,809 million, $2,293 million, $3,315 million and $2,715 million in the first, second, third and fourth quarter of 2021, respectively. (5) Alliance Revenue represents Merck's share of profits from sales in Bayer's marketing territories, which are product sales net of cost of sales and commercialization costs. (6) Net product sales in Merck's marketing territories. (7) Total Diabetes sales were $1,305 million, $1,300 million, $1,231 million and $1,012 million in the first, second, third quarter and fourth quarter of 2022, respectively, and $1,363 million, $1,330 million, $1,417 million and $1,475 million in the first, second, third and fourth quarter of 2021, respectively. (8) Includes Pharmaceutical products not individually shown above. (9) Other Revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. Other Revenues related to the receipt of upfront and milestone payments for out-licensed products were $114 million, $32 million, $10 million and $10 million in the first, second, third and fourth quarter of 2022, respectively, and $56 million, $135 million and $27 million in the first, third and fourth quarter of 2021, respectively.