Nirmatrelvir/Ritonavir

Seven of the biopharma industry's top 25 companies saw their revenue decrease in the first quarter of 2025, all from the U.S. The declines came after revenues boomed in the fourth quarter of 2024. After a fourth quarter in which revenue boomed throughout the biopharma industry, there were reversals for several drugmakers in the first three months of 2025. The companies that took the biggest hits were in the U.S., where there is already considerable angst in the industry over the tariff threats and drug price-slashing aspirations of President Donald Trump, along with the unsettling prospects of having a pharma adversary, Robert F. Kennedy Jr., heading up the Department of Health and Human Services.Among the top 25 revenue companies in the industry in the first quarter, there were seven that saw year-over-year sales declines, all from the U.S. Viatris took the biggest hit at 11%, followed by Pfizer (-8%), Organon (-7%), Bristol Myers Squibb (-6%), Regeneron (-4%), Merck (-2%) and Gilead (-0.3%).Additionally, only two of the top 25 companies in the industry—Daiichi Sankyo (6%) and Novartis (0.6%)—had sequential revenue increases in the first quarter, though analysts warn that fourth quarter sales can skew positively, with drugmakers often expecting a sequential slide.While many factors are at play with the political landscape that could have depressed sales in the first quarter, most companies that saw first-quarter declines cited non-macroeconomic reasons for their results.The decline for Viatris, for example, was not a surprise. Its annual revenue has decreased each year since 2021 as the Pittsburgh-based company has executed a series of selloffs. But it still was Viatris’ largest quarterly sales decrease—on a percentage basis—since the company was formed in 2020 with the merger of generics specialists Mylan and Upjohn.The drop-off for Pfizer can be chalked up (PDF) to a decline in sales for COVID-19 antiviral Paxlovid, which plummeted from $2 billion in the first quarter of 2024 to $491 million in the first quarter of 2025. In recent years, revenue for the company has varied dramatically based on the demand for its COVID products. For example, last year in the first quarter, Pfizer delivered a 19% year-over-year decrease. Two quarters later, sales were up 32%.Another factor in the sales slide for Pfizer—as well as that for BMS—was a premature decline in the sales for Eliquis. The megablockbuster blood thinner, which is shared by the New York City drugmakers, is set for a Medicare price reduction next year under the Inflation Reduction Act (IRA). But it is already facing market headwinds, as its sales fell by 4% in the first quarter.In its earnings release, Pfizer explained that the decline was driven primarily by a “lower net price in the U.S., including the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign.”The 6% decrease in the first quarter for BMS came after the company reported increases of between 5% and 9% in each of the four quarters in 2024. Also tied to the decline for BMS were plummeting sales of aging blood cancer drugs Revlimid, Pomalyst and Imnovid.The sales shortfall for Regeneron, which came after the company posted double-digit increases in each of the previous three quarters, highlighted the continuing struggles of eye disease treatment Eylea and Eylea HD, which saw a combined 16% year-over-year sales free fall from $2.25 billion to $1.90 billion.Regeneron cited a host of issues, including “competitive pressures,” which is a reference to Roche’ surging Vabysmo. Launched in 2022, the drug has robbed Eylea of its dominance of the market—especially in the U.S.Regeneron also said sales were affected in the period by an 11% sequential decrease in “physician unit demand,” in addition to lower net selling prices and lower wholesaler inventory levels. Additionally, the company warned of continuing headwinds affecting Eylea sales this year.The sales drop for Merck came after increases in the previous seven quarters, thanks largely to juggernaut cancer treatment Keytruda. But in Q1, a YOY increase in Keytruda sales from $6.9 billion to $7.2 billion could not compensate for a free fall in Gardasil sales, from $2.2 billion to $1.3 billion, as the company continues to navigate demand declines in China.“We see significant risk to the Gardasil franchise, as China woes continue,” Leerink Partners analyst Daina Graybosch, Ph.D., said in a note to investors.There are even signs of a slowdown for Keytruda, which had its first sequential sales decline since the first quarter of 2020—and the drop was significant, from $7.8 billion in the fourth quarter of 2024 to $7.2 billion in the most recent earnings period.No shortfall for surging Lilly While many other American companies navigated various hurdles in the first quarter, there was nothing to slow the roll of Eli Lilly. Fueled by still-growing demand for its diabetes and obesity drugs, Lilly saw sales increase by 45%, which was more than twice that of any other company among the 25 that generated the most revenue in the industry in the period.It was the second straight quarter in which Lilly achieved a 45% YOY increase in sales and the eighth quarter in a row that Lilly pulled off a quarterly increase of at least 20%. Much of the run can be attributed to booming sales of diabetes drug Mounjaro and its obesity follow-on Zepbound. In the first quarter, the duo rolled up combined sales of $6.1 billion.Lilly has seized the momentum in the market from Novo Nordisk, which recently decided to start a CEO search and move on from its longtime leader Lars Fruergaard Jørgensen. In contrast, in the first quarter, Novo had a 19% sales increase. It was the first time since the fourth quarter of 2021 that Novo’s quarterly sales boost came up short of 20%. Combined sales of Novo’s diabetes drug Ozempic and obesity follow-on Wegovy still exceeded those of Lilly’s corresponding drugs, coming in at $7.5 billion in the quarter. But the gap is quickly shrinking. Expect Novo’s headwinds to continue throughout this year. In its first quarter report, the Danish company slashed its annual revenue projection from a window of 16% to 24% to one of 13% to 21%. At the midpoint of its 2025 revenue projection, Lilly expects a sales increase of 41%.Other gainers in Q1 In addition to Lilly and Novo, there were four other companies that accomplished double-digit revenue gains in the first quarter, including Japanese companies Daiichi Sankyo (+21%) and Astellas (11%). Both drugmakers are enjoying sales growth as a result of successful Big Pharma-partnered cancer medicines.The other two double-digit gainers—Novartis (+12%) and Sanofi (+11%)—are growing after executing sell-offs to become pure-play innovators. Among its divestments, Novartis spun off its generics and biosimilars unit Sandoz, while Sanofi recently sold a controlling stake in the consumer health business Opella. Also of note among the other companies that saw revenue increases in the period was Amgen’s 9% figure, which was its first true quarterly growth measure since completing the $27.8 billion acquisition of Horizon Therapeutics in October 2023.  AbbVie’s 8% boost was its largest quarterly increase since the third quarter of 2021, indicating that the company has compensated for the loss of patent protection for powerhouse Humira with its pair of next-gen immunology treatments Skyrizi and Rinvoq. The quarterly increases for AstraZeneca (+7%) and Vertex (+3%) came after both companies had double-digit annual growth in 2024. On the flip side, the gains for Biogen (+6%) and Bayer (+4%) come after both companies saw saw their revenues slide in 2024.  

氨基观察-创新药组原创出品作者 | 郑晓新冠进入周期性流行。中国疾控中心、香港卫生署、新加坡卫生部和传染病监测管理局的监测数据显示，自4月以来，新冠病毒感染持续增加，部分地区阳性率已接近一年高点，预计将在近期达峰。好在，虽然不同地区流行的新冠毒株存在差异，未见明显毒力变化。大流行下，新冠卷土重来又成为热搜，这也不可避免让预防、治疗手段重新回到大众视野。尴尬的是，相比于几年前，有效的新冠防治武器已经太久没有进化，甚至还可能缩减了。企业层面，出于对自费市场的低预期，一些疫苗企业并未继续投入新冠疫苗的推广，而是将之视为“包袱”。即便还没被放弃的新冠疫苗，能够获得倾斜的资源也非常有限。相比疫苗产品被“战略抛弃”，口服药还得到了部分药企的重视。当前，资本市场也自然对这些口服药概念股展现了极大的热情。不过，相比于资本短期的炒作，对于企业来说，如何在与新冠的斗争过程，既能避免极高的资源消耗、又能兑现合理的商业预期，或许会是长期存在的话题。毕竟，从海外企业的表现来看，如今新冠疫苗和口服药的销售额规模并不小，商业价值仍然媲美大众所熟知的重磅品类。/ 01 /战略性放弃的资产在全球新冠防、治的热闹时期，中国创新力量是最为强劲的一股力量。从疫苗的研发到口服药的攻坚，不管是数量还是质量，都处于领先的位置。但目前，随着全球进入后新冠时代，全球药企对于新冠业务的战略优先级都大幅下降，只是中国药企放弃得更加彻底。新冠疫苗方面，国内选手基本处于战略性放弃状态。例如，此前在接受媒体采访中，就有新冠疫苗研发明星企业董事长表示，经过了这两年的消化，逐渐将新冠的“包袱”卸下了。而三叶草生物，虽然有新冠疫苗获批，但从其目前的战略来看，显然是全力all in新领域——RSV疫苗。相比之下，获批的口服药，受到的重视程度要更高，药企仍在推动商业化。疫情期间，国内批准了6款小分子新冠药物附条件上市。除了Paxlovid和Molnupiravir这2款高价进口药物，还有阿兹夫定、民得维、先诺欣和乐睿灵4款国产药物。部分国产新冠口服药仍在继续推动，药物进入药房等商业化工作。也正因此，在这一波流行中，部分企业的新冠口服药收获了一定的增量。例如，先声药业就对媒体表示，近期公司抗新冠创新药先诺欣的同比和环比销量数据均显著上涨，但具体数据未透露。当然，客观来看，药企对新冠口服药的重视程度也有所下降，也有药企所谓的“推进”也只是形式大于实际。这也意味着，对这些药企来说，新冠业务算是已经彻底翻篇了。/ 02 /薛定谔的需求商业行为，存在即合理。药企选择战略性放弃新冠资产的原因不难理解。如果继续“重视”，面临不菲的成本。除了常规的产业化、商业化运营成本，可能还包括在临床研究环节的持续性投入。例如，日前Novavax新冠疫苗获得完全批准，但被FDA要求进行4 期前瞻性研究， 在50至64岁无高风险情况的个体中进行的随机、双盲、安慰剂对照疗效和安全性试验。对此，Novavax也表示，需要评估这项新试验的资金和执行情况。因为疫苗需求有可能被监管抑制。5月20日，FDA局长Makary和新任的FDA CBER（负责疫苗审批）主任Prasad在《新英格兰医学杂志》上发表文章，宣布大幅限制新冠疫苗的使用。对于国内药企来说，投入端的成本不菲，然而，国内新冠防治需求可谓是薛定谔的。最典型的，就是疫苗的需求。自2024年7月15日起，国内新冠病毒疫苗不再免费接种，调整为自费接种。然而，当前新冠疫苗的价格基本都高于当前流感疫苗价格。根据山东省药械集中采购平台去年8月份公布的数据，价格最低的鼻喷流感病毒载体新冠肺炎疫苗，由万泰生物生产，0.2毫升/支的价格为136元；价格最高的是吸入用重组新型冠状病毒XBB.1.5变异株疫苗，由康希诺生产，0.5毫升/支（3次人用剂量）的价格为1114元，单次价格为371.3元。其他几款疫苗单次价格均在300元左右。另外，根据安徽省公布的2024年新冠病毒疫苗采购目录，相同产品价格与黑龙江省、山东省类似，安徽还将石药集团的mRNA疫苗（Omicron XBB.1.5）纳入，价格为598元/瓶。这样的自费价格，显然会影响自费接种需求。加之对新冠疫苗的错误认知，如接种疫苗后仍被病毒感染，导致需求会进一步逼仄。这种情况下，药企继续大规模投入，似乎并不是一个明智的商业选择。新冠疫苗如此，口服药可能也不会例外。价格层面，口服药也不会太低，更重要的是，目前不管是医院层面的治疗，还是民众对于新冠的认知，都在下降。至少，当出现症状之后，第一时间去思考是否新冠，或者是主动核酸检测的比例并不会太大。这样的逻辑下，市场对口服药的需求也必然是有限的。也正因此，不管是新冠疫苗还是新冠口服药，企业进行战略性收缩，也算是无奈之举。/ 03 /错过的机会从海外企业的表现来看，又难言放弃是否正确。因为国内企业的主动放弃，正在与海外药企当下所获得的回报形成鲜明对比。海外新冠疫苗和治疗药物的需求，可能仍然超出大众认知。2024年，辉瑞的两款新冠产品——Paxlovid和Comirnaty依然为辉瑞带来超110亿美元销售额。其中，Paxlovid达到57亿美元，Comirnaty达到53亿美元。这样的表现，绝对属于现象级表现。以疫苗为例，辉瑞的另一王炸产品20价/13价肺炎疫苗Prevnar family，2024年全年销售额也不过64.11亿美元。进入2025年，辉瑞两款产品表现有所波动，但仍然反映出需求存在且不低的事实。一季度，Paxlovid收入仅4.91亿美元，大幅低于预期的9.02亿美元；但新冠疫苗 Comirnaty贡献5.65亿美元，同比增长62%，超分析师预测的3.255 亿美元。Novavax的新冠疫苗则得益于两项预购协议（APA）终止后确认的收入，销售额达到6.01亿美元，同比大幅增长641%。这也充分验证了，只要新冠病毒不像当初的SARS病毒般自我消失，那么新冠药物的商业价值仍然是不可忽略的。当然，这种高增长能否持续，也要继续观察。毕竟，在特朗普政府主导的政策下，美国未来的疫苗领域和市场走向成迷。回到国内来说，新冠的起伏是波动的，防治又掺杂了太多因素，必然不能完全用海外视角来看待国内企业。只是，随着新冠的起起伏伏，加上海外药企的突出表现，或许值得国内药企重新审视新冠防治需求。PS：欢迎扫描下方二维码，添加氨基君微信号交流。