Capvaxive

2024年10月31日，默沙东发布了2024Q3季度财报，公司第三季度营收达166.57亿美元，同比增长4%；前三季度营收485.44亿美元，同比增长7%。 虽然默沙东的肿瘤学重磅药物Keytruda在第三季度再次实现了数十亿美元的销售佳绩，但在公司的收益电话会议上，其另一款主打产品在中国遭遇的地区性问题却成为了众人瞩目的焦点。 在全球范围内，默沙东的Gardasil系列产品的销售额与去年相比下降了11%至23亿美元。默沙东首席执行官Robert Davis在周四举行的第三季度电话会议上指出，这一下滑是由于中国市场需求减少所致，而这抵消了“几乎所有其他地区”的两位数增长。 在此期间，默沙东对其中国商业化合作伙伴的库存出货量有所下降，预计第四季度也将保持这一发货水平。不过，Davis表示，默沙东在改善中国的患者教育并增加推广资源方面正在“取得进展”，当然这也需要一些时间。 Gardasil系列产品是默沙东仅次于Keytruda的第二大销售驱动力，公司坚信到2030年，该核心产品能带来超过110亿美元的收入。Davis表示，全球范围内，只有不到10%的符合条件的人群接种了该类疫苗，而在中国和世界各地都存在着“广泛的长期增长机会”。 尽管存在全球增长机会，但默沙东高管警告称，该产品在中国的收入可能会在2025年再次下降。“我想确保每个人都听到的是，这不会在下一季度就得到解决，”Davis强调道。 与此同时，默沙东的肺炎球菌结合疫苗Capvaxive最近获得了美国疾病控制与预防中心（CDC）疫苗咨询小组的关键推荐，建议将其使用范围扩大到所有50岁及以上成人，而此前仅推荐65岁及以上人群接种。美国在50岁以上年龄的人群约有1.2亿，其中6000万人在50至64岁之间，公司首席财务官卡Caroline Litchfield指出，这一新推荐为Capvaxive带来了“巨大的机遇”。 该疫苗将与辉瑞的Prevnar 20疫苗展开竞争，后者也已获得CDC批准用于50岁及以上人群。然而，据默沙东称，其疫苗具有独特优势，因为它是唯一一种专为50岁及以上成人设计的肺炎球菌病疫苗，覆盖了导致该年龄段人群84%疾病的21种血清型。 根据更新后的建议，Leerink Partners分析师曾预计，默沙东的该款疫苗有望在2026年在美国带来额外的7亿美元收入。 参考资料： [1]Gardasil's China troubles haunt Merck in Q3, with execs warning of more obstacles ahead.By Zoey Becker.Oct 31, 2024 1:25pm. [2]默沙东2024Q3季度财报材料. 识别微信二维码，添加生物制品圈小编，符合条件者即可加入 生物制品微信群！ 请注明：姓名+研究方向！ 版 权 声 明 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

iStock, Sundry Photography Offsetting Merck’s growth in the third quarter were disappointing revenues from its HPV vaccine Gardasil and type 2 diabetes pill Januvia, with the company on Thursday narrowing its 2024 sales and adjusted profit outlooks. Merck on Thursday reported 7% year-over-year growth in third-quarter revenues, which came in ahead of analyst forecasts, driven by its blockbuster cancer therapy Keytruda as well as strong product launches. However, the company narrowed its full-year sales forecast and lowered its adjusted profit guidance. The pharma brought in more than $16.6 billion in Q3 versus the consensus estimate of $16.46 billion—a 1% beat. Non-GAAP earnings-per-share (EPS) was $1.57, which topped the $1.48 projection by 6%. Keytruda, a PD-1 inhibitor that has become a cornerstone therapy for many cancers, was a strong driver of Merck’s Q3 beat, growing 21% to bring in nearly $7.5 billion. Analysts had expected the blockbuster immunotherapy to generate sales of around $7.3 billion in the quarter. According to Merck, the growth in Keytruda sales was driven by greater uptake in earlier-stage settings including triple-negative breast cancer, renal cell carcinoma and non-small cell lung cancer. Keytruda also saw “continued strong demand” in its other metastatic indications. Merck reported strong product launches in Q3 including the pulmonary arterial hypertension Winrevair, which secured $149 million and surpassed analyst estimates of $129 million. The company also touted its pneumococcal vaccine Capvaxive, which the FDA approved in June 2024 and the CDC recommended for use in adults 50 years and older last week . However, offsetting Merck’s strong growth in Q3 were disappointing sales of its nine-valent HPV vaccine Gardasil and its type 2 diabetes pill Januvia. Gardasil absorbed a 10% year-over-year revenue hit, bringing in a little more than $2.3 billion in the quarter and missing the consensus estimate of more than $2.57 billion. Meanwhile, Januvia sales nosedived 49% with sales of $278 million, missing the forecast of $421 million. Looking ahead to the rest of the year, Merck lowered its full-year EPS guidance to $7.72 to $7.77—versus the previously announced range of $7.94 to $8.04—to reflect one-time charges associated with transactions with Harpoon Therapeutics, EyeBio and Curon Biopharmaceutical. The company also narrowed its sales forecast to $63.6 billion to $64.1 billion. The pharma’s previously announced projection ranged from $63.4 billion to $64.4 billion. Guggenheim Partners analyst Vamil Divan in a note to investors called Merck’s overall performance in Q3 “solid” but said the pharma needs to provide more clarity regarding its expectations for Winrevair and Capvaxive for the coming quarters—as well as its outlook for Keytruda and Gardasil as market pressures mount. BMO Capital Markets analyst Evan Seigerman noted that “Merck’s commercial story remains strong” as “Keytruda continued its usual dominance,” pointing out that Merck has properly positioned itself for continued growth in the coming years, despite Keytruda’s impending loss of exclusivity (LOE). “We believe Merck’s developing cardiovascular portfolio, advancements in I&I (immunology and inflammation) through the Prometheus transaction, and partnership with Daiichi are likely to position the company to grow through its Keytruda LOE and add to the company’s topline for several years,” Seigerman wrote. At the same time, he commented that “another sequential Gardasil miss ($2.31B vs $2.58B) suggests issues from 2Q24 are persisting” and “remains a concern” with the HPV vaccine’s revenues down 10% versus consensus “likely continued to be impacted by problems in China.”