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GSK 2018财报:带状疱疹疫苗Shingrix横空出世,重返肿瘤四面出击

医药魔方 医药魔方 来源:医药魔方
2019-02-09
葛兰素史克 财报
原文

2月6日,GSK公布2018年业绩,全年总收入308.21亿英镑(409.92亿美元),相比2017年增长5%。其中制药业务收入173亿英镑(+2%),疫苗业务收入59亿英镑(+16%),消费者保健业务收入77亿英镑(+2%);2018年GSK研发投入38.93亿英镑(51.78亿美元),占收入比重12.6%,相比2017年下降13%。


GSK当前的优势业务集中在呼吸疾病、艾滋病和疫苗三大领域。


呼吸疾病业务方面,Ellipta系列产品销售收入整体增长了32.3%,达到27.25亿美元。Nucala是全球首个上市的IL-5单抗,用于治疗嗜酸性难治性哮喘,随着在更多国家的获批,Nucala的销售额在上市第三年来到了7.49亿美元。这些新产品弥补了Seretide掉下专利悬崖的影响,维持了整个呼吸业务板块的增长势头。


艾滋病业务方面,在dolutegravir系列产品带动下实现了11%的增长,整体收入达到61.87亿美元。吉利德的艾滋病业务大约为150亿美元。


疫苗方面,带状疱疹疫苗Shingrix在2017年10月获得加拿大和美国的批准,紧接着又被美国CDC推荐50岁以上老人接种,2018年销售收入直接突破10亿美元,带动GSK整个疫苗板块增长了16%,并且成功抢下美国市场98%的份额,把默沙东老牌产品Zostavax的销售额从2017年的6.68亿美元直接打到了2.17亿美元。GSK和默沙东另外一组针锋相对的疫苗产品是宫颈癌疫苗Cervarix和Gardasil 9,现实境况也是天壤之别反。Gardasil 9在中国遭遇哄抢,供应极度紧张,2018年全球收入暴涨37%来到31亿美元;Cervarix不仅无人问津从美国撤市,2018年全球收入也仅有1.84亿美元(+5%)。



GSK在2014年进行了重大业务调整,用整个肿瘤业务资产置换了诺华的疫苗业务资产(不包括诺华的流感疫苗),同时与诺华成立了专注于消费者保健业务的合资公司,GSK占股63.5%。减负后的GSK在艾滋病业务板块强势复苏的带领下,确实回到了增长的轨道。不过GSK抛弃掉的肿瘤产品Tafinlar+Mekinist以及血小板减少性紫癜药物Revolade/Promacta(艾曲波帕)在诺华手下也都成了10亿美元的重磅炸弹。


随着2015年肿瘤免疫治疗产品的兴起,GSK又开始有各种口径对外表示依然会将肿瘤业务作为战略重心之一。从消费者保健业务板块升任CEO的Emma Walmsley在2016年3月就任之初就开始着手对GSK的业务架构重新进行调整,宣布为了提高研发效率而削减部分早期研发项目,并且要将80%的研发资金集中在艾滋病、呼吸、肿瘤、自身免疫性炎症疾病上面,这是了GSK下决心重返肿瘤领域的信号。


此后,GSK重新开始通过外部合作对肿瘤业务进行布局,包括2016年3月与Mitenyi Biotech签订了细胞和基因治疗药物研发合同,共同研究未开发的的CAR-T肿瘤靶点;2016年4月与Zymeworks合作开发双特异性抗体等。从官网上可以发现GSK目前的肿瘤管线中有2个II期项目,包括TCR-T细胞疗法,靶向BCMA的抗体偶联药物,6个I期项目,包括BET、OX40、TLR4、PI3K等靶点。


GSK在2018年12月宣布以51亿美元收购Tesaro相当于是在肿瘤圈怒刷一波存在感,同时也获得了针对PARP、PD-1的项目以及探索各种肿瘤免疫组合疗法的空间。就在前天,GSK还与德国默克围绕M7824这一个双功能蛋白药物签订了37亿欧元的深度捆绑合作(见:默克/GSK建立全球合作联盟,签订37亿欧元升级版PD-1开发协议),也是GSK对肿瘤领域进行前瞻性全面布局的又一个动作。


在公司整体战略层面,为了聚焦包括肿瘤在内的制药业务和疫苗业务,Emma Walmsley对消费者保健业务也动起大手术,先是在2018年3月以130亿美元回购了诺华持有的消费者保健业务合资公司的36.5%的股票,然后又在2018年12月与辉瑞达成协议,双方剥离出各自的消费者保健业务,成立一家新的合资公司,以GSK Consumer Healthcare的名义全球独立运营,GSK持有68%的股权,计划3年内在英国上市。这项交易计划在2019下半年完成,届时GSK的业务重心也将全部聚焦在处方药和疫苗上面。


机器翻译

On February 6, GSK reported its 2018 results, with annual revenue of 308.£2.1 billion (409.$9.2 billion), up 5% from 2017.Pharmaceutical business income is £17.3 billion (+ 2%), vaccine business income is £5.9 billion (+ 16%), and consumer health care business income is £7.7 billion (+ 2%); GSK R & D investment in 2018 is 38.£9.3 billion (51.$7.8 billion), accounting for a proportion of revenue 12.6%, down 13% from 2017.

GSK's current dominant business focuses on respiratory diseases.AIDS and vaccines in three major areas.

Overall sales of Ellipta family products increased by 32.3%, reaching $2.725 billion. Nucala is the world's first marketed IL-5 monoclonal antibody for the treatment of eosinophilic refractory asthma, with approval in more countries, Nucala Sales reached $ 749 million in the third year of listing. These new products compensated Seretide's impact on the patent cliff and maintained the growth of the entire respiratory business.

In the AIDS business, 11% growth was achieved led by the dolutegravir series, with overall revenue reaching $6.187 billion. Gilead’s AIDS business was approximately $15 billion.

In terms of vaccines, the shingle vaccine Shingrix was approved by Canada and the United States in October 2017, followed by the CDC recommended by the US CDC for over 50 years old. The sales revenue in 2018 directly exceeded 1 billion US dollars, driving the entire vaccine market of GSK. 16%, and successfully grabbed 98% of the US market, and sales of Merck's old product Zostavax directly from $668 million in 2017 to $217 million. GSK and Merck's another set of tit-for-tat vaccine products It is the cervical cancer vaccine Cervarix and Gardasil 9, the reality is also the opposite.Gardasil 9 has been looted in China and its supply is extremely tight, with global revenues soaring 37% to $3.1 billion in 2018.84亿美元(+5%).

GSK underwent a major business adjustment in 2014, replacing Novartis's vaccine business assets (excluding Novartis's flu vaccine) with its entire on-campus business assets, and establishing a joint venture with Novartis focused on consumer health, with GSK accounting for 63%. 5%. After the burden reduction, GSK has indeed returned to the growth track under the strong recovery of the AIDS business sector. However, GSK abandoned the tumor product Tafinlar+Mekinist and thrombocytopenic purpura drug Revolade/Promacta (Aiqu Popa) Under Novartis, they all became a $1 billion blockbuster.

With the rise of cancer immunotherapy products in 2015, GSK has begun to have a variety of calibre and will continue to express its focus on the oncology business. Emma Walmsley, who was promoted to CEO from the consumer health business, took office in March 2016. I started to re-adjust GSK's business structure, announced that some of the early R&D projects were cut to improve R&D efficiency, and 80% of R&D funding was concentrated on AIDS. Respiratory, tumor, autoimmune inflammatory diseases, this is GSK is determined to return to the field of cancer.

Since then, GSK has re-started the development of the oncology business through external cooperation, including the signing of a cell and gene therapy drug development contract with Mitenyi Biotech in March 2016 to jointly study the undeveloped CAR-T tumor target; in April 2016 with Zymeworks cooperates to develop bispecific antibodies, etc. From the official website, we can find two phase II projects in GSK's current tumor pipeline, including TCR-T cell therapy, antibody-conjugated drugs targeting BCMA, and six Phase I projects, including BET. OX40.TLR4. PI3K and other targets.

GSK announced in December 2018 that the acquisition of Tesaro for $5.1 billion is equivalent to a sense of presence in the tumor circle, as well as a project for PARP. PD-1 and a space to explore various combinations of tumor immunotherapy. The day before yesterday, GSK also signed an intensive 3.7 billion euro contract with Meck24, a dual-function protein drug in Germany (see: Merck/GSK to establish a global cooperation alliance, signed a 3.7 billion euro upgrade PD-1 development agreement), It is also another action of GSK's forward-looking and comprehensive layout of the tumor field.

At the company's overall strategic level, in order to focus on the pharmaceutical business and vaccine business including cancer, Emma Walmsley also launched a major operation on the consumer health business, first in March 2018 to repurchase the consumption held by Novartis for $13 billion. A 36.5% share of the health care joint venture company, and then an agreement with Pfizer in December 2018, the two sides separated their respective consumer health business, set up a new joint venture, globally independent in the name of GSK Consumer Healthcare Operating, GSK holds a 68% stake and plans to list in the UK within three years. The transaction is scheduled to be completed in the second half of 2019, when GSK's business focus will also focus on prescription drugs and vaccines.

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