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礼来2018年财报:Trulicity大卖32亿美元逼宫利拉鲁肽,肿瘤新药星火燎原

医药魔方 医药魔方 来源:医药魔方
2019-02-07
礼来 财报
原文

2月6日,礼来公布2018年业绩,全年总收入245.56亿美元,相比2017年增长7%。研发投入53.07亿美元,占收入比重21.6%,相比2017年下降1%。礼来预计2019年总收入251-256亿美元。


礼来手上虽然没有PD-1,但实际上是近几年从新药上市中获益最大的制药巨头,在糖尿病、肿瘤、自身免疫疾病、偏头痛这几个领域全面开花。尤其是2014年以后获批上市的多个新产品在2018年显著放量,弥补了Cialis(他达拉非), Effient(普拉格雷)、Strattera(阿托莫西汀)等产品失去专利保护的不利影响。而Humalog、Alimta这些个老产品能够取得增长主要是受临床需求增加和零售价格提高的影响。



从具体产品上看,Trulicity(度拉糖肽)成为礼来的当家花旦,2018年销售额约32亿美元,并且保持58%的高增速。长效GLP-1凭借便捷性和降糖减重方面的优势满足了糖尿病患者的用药需求,市场规模迅速膨胀。Trulicity在中国的上市申请目前处于“在审批”状态,大概率在本月内获批,2019年业绩仍有很大期待空间,有望抢下利拉鲁肽(38.56亿美元)在GLP-1市场的帅旗。不过Ozempic(索马鲁肽)上市第一年也亮出利牙,销售收入2.85亿美元,帮助诺和诺德捍卫GLP-1市场的领军地位。


Jardiance(恩格列净)作为SGLT-2抑制剂类降糖药中的典范,业绩和市场份额都稳扎稳打,2018年全球销售收入6.58亿美元,关键是还有47%的增幅。相比之下,市场前景要远好于强生的卡格列净(-20%)。


除了在GLP-1、SGLT-2这两个当红领域彰显实力之外,礼来的甘精胰岛素仿制药Basaglar也卖得红红火火,2018年销售额超过8亿美元,增幅超过80%。


Taltz(ixekizumab)是全球第2个上市的IL-17A单抗,随着在更多国家的获批,2018年销售收入接近10亿美元,增幅68%。虽然比起诺华first in class的的Cosentyx还有差距,但是礼来目前在自身免疫疾病领域有大分子和小分子相得益彰,JAK抑制剂Olumiant(baricitinib)晚于欧盟1年多之后终于在2018年6月获得FDA批准,2018年有2亿美元进账。


偏头痛新药Emgality在2018年9月获批,是全球第3个上市的CGRP抗体药物,2018年销售收入500万美元。Amgen/诺华的同类产品作为First in class提前了4个月,2018年销售收入是1.19亿美元。礼来认为自己偏头痛新药的优势在于消费者品牌认知和更好用的注射器。蓝海之战刚刚开始,期待看到明年的结果。


肿瘤方面,胃癌新药Cyramza(雷莫芦单抗)和乳腺癌新药Verzenio(abemaciclib)都正给礼来稳定地创造现金回报。Lartruvo(olaratuma)是近10年来上市的首个软组织肉瘤新药,2018年销售收入有50%的增长,但遗憾的是在上市后的III期验证性研究中未能确证临床获益,可能会被撤销上市资格。EMA已经建议医生不要给新患者处方该药(见:EMA:不建议使用礼来软组织肉瘤新药Lartruvo),礼来目前已经暂停Lartruvo的推广工作,正与全球监管机构沟通决定针对Lartruvo的下一步措施。


毫无疑问,肿瘤产品管线中没有PD-1的制药巨头都会觉得自己不完美,不过在已然明显落后的情况下再去盲目上马PD1就显得不明智了。礼来前不久宣布将以80亿美元收购明星公司Loxo,也是差异化地扩充肿瘤产品管线了。虽然除了老掉牙的培美曲塞,礼来并没有特别重磅的肿瘤产品,但是正如前天文章介绍的,重磅炸弹药物的开发,是时候换个思路了,肿瘤是一个庞大的疾病领域,星星之火,最终也可呈燎原之势。


机器翻译

On Feb. 6, Lilly reported its 2018 results, with annual revenue of 245.$5.6 billion, up 7% from 2017.R & D Input 53.$07 billion, as a share of revenue 21.6%, down 1% from 2017.Lilly expects total revenue of $251-25.6 billion in 2019.

Lilly does not have PD-1 on its hands, but it is actually the drug giant that has benefited the most from the launch of new drugs in recent years, in diabetes.Tumor.Autoimmune disease.Migraine is a full-blown field.In particular, a number of new products approved for marketing after 2014 have significantly increased in volume in 2018, making up for Cialis (tadalafil) and Effient (prasugrel).The adverse effects of the loss of patent protection for products such as Strattera (atomoxetine).而Humalog. The growth of Alimta's old products is mainly due to increased clinical demand and higher retail prices.

From a specific product point of view, Trulicity has become a gifted company, with sales of about $3.2 billion in 2018 and a high growth rate of 58%. The long-lasting GLP-1 relies on convenience and hypoglycemic reduction. The advantages of the other aspects meet the demand for diabetes patients, and the market scale is rapidly expanding. Trulicity's application for listing in China is currently in the “approval” status, and the probability is approved within this month. There is still much room for expectation in 2019. It is expected to grab the handsome flag of Liraglutide ($3.856 billion) in the GLP-1 market. However, the first year of Ozempic (Somarupeptide) also appeared in Liya, sales revenue 2. $8.5 billion to help Novo Nordisk defend its lead in the GLP-1 market.

Jardiance, a model of SGLT-2 inhibitors, has a steady performance and market share. In 2018, global sales revenue was $658 million, and the key is a 47% increase. In contrast, the market outlook is much better than Johnson & Johnson's cardinal (-20%).

In addition to its strength in the two popular areas of GLP-1. SGLT-2, Lilly's insulin syrup generics, Basaglar, also sold well. In 2018, sales exceeded $800 million, an increase of more than 80%.

Taltz (ixekizumab) is the world's second listed IL-17A monoclonal antibody. With more approvals in more countries, sales in 2018 are close to $1 billion, an increase of 68%. Although compared to Novartis first in class of Cosentyx There are still gaps, but Lilly currently has macromolecules and small molecules in the field of autoimmune diseases. The JAK inhibitor Olumiant (baricitinib) was finally approved by the FDA in June 2018 after more than a year in the EU, and 200 million in 2018. The dollar is credited.

Emmigal, a new migraine drug, was approved in September 2018. It is the world's third marketed CGRP antibody drug with a sales income of $5 million in 2018. Amgen/Nova's similar products were sold as First in class for 4 months, sold in 2018. The income is 1. $1.9 billion.Lilly believes its new migraine drug has the advantage of consumer brand recognition and better syringes. The Battle of the Blue Sea has just begun and looks forward to seeing the results next year.

On the tumor side, the new gastric cancer drug Cyramza (remollozumab) and the new breast cancer drug Verzenio (abemaciclib) are giving Lilly a steady return on cash. Lartruvo (olaratuma) is the first soft tissue sarcoma drug listed in the last 10 years, 2018 Sales revenue has increased by 50%, but unfortunately the clinical benefit has not been confirmed in the Phase III validation study after the listing and may be revoked. EMA has recommended that doctors not prescribe new drugs to patients (see: EMA: Lilly Ruvo, a new medicinal sarcoma drug, is not recommended. Lilly has suspended Lartruvo's promotion and is communicating with global regulators to determine the next steps for Lartruvo.

There is no doubt that the pharmaceutical giants without PD-1 in the tumor product pipeline will feel that they are not perfect, but it is unwise to go blindly to PD1 after it is clearly behind. Lilly has announced that it will be 8 billion US dollars. The acquisition of the star company Loxo is also a differential expansion of the tumor product pipeline. Although in addition to the old pemetrexed, Lilly does not have a particularly heavy tumor product, but as the article from the day before yesterday, the development of blockbuster drugs is When I change my mind, the tumor is a huge disease field, and the fire of the stars can finally be a prairie.

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