Starboard Medical, Inc.

Pfizer CEO Dr Albert Bourla presided over an exceptional Q3 amid financial decline and pressure from investor Starboard Value. Credit: Ververidis Vasilis / Shutterstock. Pfizer has reported strong revenues in its latest earnings report, noting increased revenues over Q3 2023 largely due to sales from the company’s Covid-19 drugs Paxlovid and Comirnaty. In the 29 October report, Pfizer stated overall revenues in Q3 2024 had risen by 31% compared to the same quarter in the previous year, amounting to an additional $4.3bn. Of the total $17.7bn in Q3 revenues, $2.7bn and $1.4bn were derived from sales of Paxlovid and Comirnaty, respectively, which together accounted for almost half of the company’s year-over-year growth. The robust Q3 report did little to affect share price, although traded share volume rose to a level unseen since the company acquired Seagen in December 2023. Pfizer’s market cap is currently $161bn. This month has also seen disruption to the company’s management, as activist hedge fund Starboard Value took a $1bn stake in Pfizer, equivalent to 0.6% of the company at the time of purchase. Aiming to steer a turnaround in Pfizer’s fortunes, Starboard accused company executives of “ coercive conduct ” against former CEO Ian Read and former CFO Frank D’Amelio who retracted support after initially supporting the fund’s plans. In the Q3 conference call, Pfizer CEO Albert Bourla stated: “While we agree with some of the points [Starboard] raised, we have vastly different views on many others.” See Also: How a patient helped shape a treatment for rare skin disorder ARIA-E risk of Lilly’s Kisunla in Alzheimer’s reduced with modified dosing He noted common dissatisfaction with shareholder return, but disagreed with Starboard’s challenge of Pfizer’s capital deployment, saying the company’s deals with Seagen and BioNTech “have been transformational for Pfizer”. Nonetheless, Bourla said some changes have been made at Pfizer this year to address Starboard’s such as separating US and international business and restructuring company management. The 31% Q3 growth over Q3 2023 was in sharp contrast to the overall growth of 2% for the first nine months of 2024 compared to those of 2023. Consequently, Pfizer has adjusted its financial guidance, raising projected revenues for 2024 to between $61bn and $64bn, up $1.5bn from estimates made in the company’s Q2 statement. This includes estimated sales of $5bn and $5.5bn from Comirnaty and Paxlovid, respectively, bringing the full year’s expected growth to 9% to 11% over 2023. Pfizer also attributed upticks in 2024 Q3 revenue to $854m in quarterly sales due to its acquisition of Seagen. Alongside this were increased operational revenues of 9% for Eliquis (apixaban), 28% for Xtandi (enzalutamide), 45% for Vydura (rimegepant sulfate), and 63% for Pfizer’s Vyndagel family (tafamidis) against equivalent quarterly revenues the previous year. Some drug-specific revenues did see decreases. Namely, revenues for Xeljanz (tofacitinib citrate) were down 35% and decreased by 12% for Ibrance (palbociclib) compared to Q3 2023. Drops in sales were attributed to label changes, lowered US net price, and expiry of exclusivity in Canada for Xeljanz, as well as competitive pressure and international price decreases for Ibrance. Bourla and Pfizer CFO David Denton gave statements attributing the company’s strong Q3 in part to ongoing cost reduction efforts and heightened demand for Paxlovid during the recent wave of Covid-19.

生物医药行业总是风云变幻。 2022年，辉瑞公司年收入突破千亿美元，成为全球营收最多的制药企业。然而，随着新冠疫情迅速退潮，2023年营收下降了41%，营收排名也从第一跌到了第四。 近日，著名的激进投资机构Starboard value携10亿美元入股辉瑞，将给这家制药巨头带来怎样的改变？ 01 千亿美元大厂 1849年，Charles Pfizer和Charles Erhart在纽约创立了辉瑞公司，最初以生产化工产品为主。二战期间，辉瑞成功量产青霉素，又推出了土霉素，正式进军制药行业。此后，辉瑞通过研发和并购不断扩张，推出了如络活喜、万艾可等重磅药物，并逐渐成为全球领先的制药企业。 进入21世纪以来，辉瑞从2001年到2013年连续蝉联全球制药企业50强（Pharm Exec Top50）榜首，被称为“宇宙药厂”。 2020年，COVID-19新冠病毒席卷全球，辉瑞与BioNTech合作，迅速推出了mRNA COVID-19疫苗Comirnaty，又自主开发了新冠口服药物Paxlovid。 图片来源：参考资料 凭借这两款新冠产品的畅销，2021年辉瑞销售收入达到720.43亿美元，2022年辉瑞公司的收入更是突破了千亿美元，达到了1003亿美元，创下了公司174年历史上的最高纪录。 其中COVID-19疫苗Comirnaty在2022年的销售额为378亿美元，新冠口服药物Paxlovid在2022年的销售额为189亿美元，新冠相关产品收入合计567亿美元。 但是，疫情很快发生了变化，2023年新冠产品的销售额并没有如辉瑞预计的那样继续畅销。 2023年，Comirnaty和Paxlovid合计销售额125亿美元，远低于辉瑞管理层预计的215亿美元。而2024年，这两款产品的继续大幅下降，没有实现辉瑞预期额增长。 或许是新冠疫情变化太快，辉瑞应对不足，导致营收大幅下降，2023年全年收入585亿美元，同比下降41%。 资本市场上，辉瑞目前股价不到30美元，比2021年12月高点的近60美元，降低了50%，甚至略低于疫情前的水平。 02 质疑声起 近日，Starboard准备了一份关于辉瑞的投资者峰会演示文稿，讨论了辉瑞的市场表现、研发管线、以及并购投资等。 首先，他肯定了辉瑞在新冠疫情中做出的贡献，但他认为，辉瑞的之后表现落后于同行和市场，包括研发管线不及预期、巨额并购没有带来预期的回报等。 在研发方面，辉瑞曾在2018年定下未来5年内推出15个“重磅炸弹”的目标，然而回看这些管线，辉瑞遇到了不少挑战。 图片来源：参考资料 过去几年，辉瑞除了在新冠产品上的成功，还推出了不少创新药，例如： Vyndaqel(tafamidis meglumine)是辉瑞开发的一款口服TTR稳定剂，于2019年获得美国FDA批准，是首个也是唯一一个治疗ATTR-CM的药物。2023年Vyndaqel系列药物销售额为33.2亿美元，今年上半年该药销售额24.6亿美元，同比增长68%。 PCV20（Prevnar 20，20价肺炎球菌结合疫苗）成功接替了PCV13，成为辉瑞业绩的一大亮点。 RSV疫苗Abrysvo在2023年5月获批后，首年即产生了8.9亿美元的收入。 但是，不达预期的项目也有很多。例如，Bavencio虽已获得监管机构批准上市，但距离“重磅炸弹”门槛（10亿美元）还尚远。而且辉瑞在2023年3月终止了与默克的合作，并将相关权益转交给默克。Cibinqo(JAK1)、Litfulo(JAK3)两款自免新药放量也较慢。 另外，C.Difficile疫苗、Rivipansel、Tanezumab等新药未能顺利获批上市，而且其重磅乳腺癌药Ibrance一项III期研究结果不佳。 而在热门领域，Bourla将GLP-1项目视为潜在的100亿美元产品。但由于安全性等问题，辉瑞终止了第二代小分子GLP-1R药物lotiglipron(PF-07081532)的开发。Danuglipron（每日口服两次）也因为副作用导致的高退出率。而后，辉瑞又推出了每日口服一次的改良版danuglipron，目前其用于治疗型糖尿病和肥胖两个适应症均处于临床Ⅰ期。另一款口服小分子GLP-RA药物PF-06954522也还处于临床Ⅰ期，进度落后于竞争对手。 在并购方面，辉瑞在新冠产品获得充沛现金流后，其“巨额并购”的基因觉醒，斥资430亿美元收购ADC公司Seagen。疫情以来，辉瑞用于并购的资金更是高达700亿美元。 表1 辉瑞的部分巨额并购 数据来源：辉瑞官网以及公开信息整理 但是，这些并购没能带来预期中的回报。Seagen在2024年上半年，为辉瑞带来了15.87亿美元的收入。但这与辉瑞此前预测的“到2030年，Seagen系列产品有望贡献超100亿美元的年销售额”还有不少距离。 另外，辉瑞在2022年以54亿美元的价格收购Global Blood Therapeutics，获得了镰状细胞病药物Oxbryta（voxelotor）。但近日，出于对患者最佳利益考虑，辉瑞从全球市场撤回了这款药物。 祸不单行，2022年辉瑞以5.25亿美元收购ReViral，获得的两个RSV候选药物Sisunatovir和RV-299（RSV N蛋白抑制剂）也相继被辉瑞从管线中剔除。 03 转折将至？ 辉瑞无论是自研，还是外部引进的管线似乎都遇到了不小挑战。而新冠疫情又变化太快，辉瑞新冠产品没能给公司带来预期的收入，针对辉瑞的质疑声越来越多。 此时，Starboard value携10亿美元入股辉瑞，虽然其股票占辉瑞总市值不到1%，但其可以通过各种方式说服其他股东加入自己的阵线，迫使管理层调整策略。 据悉，Starboard Value由杰夫·史密斯（Jeff Smith）创立，风格强势，是华尔街最令人“畏惧”的激进投资机构之一。其通常的投资策略是，持有公司部分股权，力图对公司管理层和董事会施压，推动公司进行战略调整、削减成本、推动并购和改革，以优化运营效率，提升价值，为股东带来更高回报。 这一次，Starboard Value问责辉瑞，指出导致其市值下跌的一系列原因，包括内部研发不顺利、管线估值低、巨额并购回报有限、未能达到预期的业务目标等问题，并敦促辉瑞降本提效，调整策略。 实际上，辉瑞早已开始调整，2023年辉瑞宣布削减40亿美元开支的计划，今年5月又公布了一项新计划，到2027年底再削减15亿美元开支。基于这两项计划，辉瑞在去年和今年都进行了多次裁员。 在人事上，辉瑞也频繁调整，聘请了前诺华美国肿瘤业务的高级副总裁Tina Deignan担任肿瘤学商业化负责人，以帮助公司实现到2030年销售8种重磅药物的目标。另外，辉瑞首席科学官兼研发总裁Mikael Dolsten博士也将离职，辉瑞正在寻找研发部门的下一任负责人。 无论是否受制于Starboard Value的压力，辉瑞都已开始改变，相信在不久的将来，我们将看到这家制药巨头的新面貌。 参考来源： 1.https://www.fiercepharma.com/pharma/starboard-wants-hold-pfizer-leadership-accountable-overpaid-ma-deals-poor-return-rd 2.https://www.pfizer.com/news/press-release/press-release-detail/tim-buckley-elected-pfizers-board-directors 3.辉瑞：2024 Active-Passive Investor Summit 声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。 责任编辑 | 小月石 转载开白 | 马老师 18996384680（同微信） 商务合作 | 王存星 19922864877（同微信）  阅读原文，是受欢迎的文章哦

hapabapa/Getty Images CEO Albert Bourla, who is under attack from activist investor Starboard Value, got a much-needed victory on Tuesday as Pfizer reported that third-quarter revenue and adjusted profit beat the analysts’ consensus. With a $1 billion stake in Pfizer, activist investor Starboard Value has recently criticized CEO Albert Bourla and senior management for “dramatically” underperforming peers and the market. However, the company on Tuesday reported its third consecutive quarter of positive results , handily beating Wall Street’s expectations. In Q3, Pfizer secured revenue of $17.7 billion compared to the consensus estimate of $14.92 billion, while reporting earnings per share of $1.06 that topped the analyst estimate of $0.62. COVID-10 antiviral medication Paxlovid brought in $2.7 billion in the quarter, up from the $202 million that Pfizer posted in Q3 2023. Guggenheim analyst Vamil Divan in a note to investors called Pfizer’s Q3 performance “very strong” and highlighted Paxlovid sales, “which beat our increased expectations by over $1B and consensus by more than $2B.” BMO Capital Markets analyst Evan Seigerman called Tuesday’s financial results a “solid” Q3 for Pfizer with a top- and bottom-line beat. The quarterly win comes at a critical time for Pfizer’s CEO, who is under pressure from Starboard Value. Analysts in recent weeks have rallied around Bourla in response to the Starboard challenge. However, Guggenheim’s Divan on Tuesday warned that “investors will continue to look for more visibility into how management hopes to navigate the various challenges they face in the coming years as many of their top products either lose patent protection or face increased competition.” Looking ahead, Pfizer on Tuesday raised its full-year 2024 revenue outlook to between $61 billion and $64 billion, up from a previous range of $59.5 billion to $62.5 billion. The company also raised its guidance on adjusted annual earnings per share to a range of $2.75 to $2.95 per share, an increase from a previous range of $2.45 to $2.65 per share. Leerink analyst David Risinger in a note to investors said Pfizer’s new guidance ranges imply a “conservative” Q4. Assuming the company achieves the high end of its new guidances, Risinger contends revenue for the final quarter of 2024 would be $17.3 billion, which is 4% below current consensus of $18.1 billion. Risinger in a separate note said that “likely in response to activist investor Starboard engagement,” Pfizer plans to showcase the company’s pipeline on Nov. 1, starting with ponsegromab—a monoclonal antibody directed against growth differentiation factor-15 (GDF-15), which showed positive results in a Phase II study in patients with cancer cachexia and elevated levels of GDF-15. The candidate is also being investigated in a Phase II study in patients with heart failure and elevated serum GDF-15 concentrations. “We learned from a clinicaltrials.gov update that Pfizer recently upsized and delayed ponsegromab’s Ph2 trial, including changing the estimated primary completion date from March 2025 to March 2026,” according to Risinger. While he awaits management comments on the rationale behind the heart failure trial changes, Risinger continues to view ponsegromab as having “multi-billion-dollar blockbuster potential in cancer cachexia due to lack of approved therapies plus potentially other indications.”