辉瑞公司（NYSE：PFE）最近提醒投资者毒品开发业务的风险。

4月14日，该公司告诉投资者，它将废除其口头GLP-1体重管理候选人Danuglipron的开发。

Pfizer (NYSE:PFE) recently reminded investors how risky the drug-development business can be. On April 14, the company told investors it would scrap development of danuglipron, its oral GLP-1 candidate for weight management. The stock has been trading about 63% below its all-time high.

辉瑞公司（NYSE：PFE）最近提醒投资者毒品开发业务的风险。 4月14日，该公司告诉投资者，它将废除其口头GLP-1体重管理候选人Danuglipron的开发。该股票的交易量低约63％。

Pfizer's stock price is way down, but the quarterly dividend it pays has risen for 16 consecutive years. At its beaten-down price, the stock offers an eye-popping 7.8% yield.

辉瑞公司的股价下跌，但它支付的季度股息连续16年增加。该股票以人为降低的价格提供了7.8％的收益率。

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If Pfizer continues its dividend-raising streak, investors who buy at recent prices could realize market-beating gains over the long run. Let's look a little closer at danuglipron, plus some bigger problems the company faces, to see if this stock could be a smart buy on the dip.

如果辉瑞继续其股息提高连胜，那么以近期价格购买的投资者从长远来看可以实现市场上的收益。让我们仔细看看Danuglipron，以及公司面临的一些更大的问题，看看该股票是否可以在下跌中明智地购买。

The end of Pfizer's oral GLP-1 program

辉瑞口头GLP-1程序的结尾

The end of Pfizer's danuglipron program highlights just how risky the drug-development process can be. According to the company, it discontinued development after just one patient in a dose-optimization study experienced a liver injury that could have been caused by the experimental GLP-1 pill.

辉瑞公司Danuglipron计划的结束突出了该药物开发过程的风险。据该公司称，在剂量优化研究中只有一名患者经历了肝损伤，这可能是由实验性GLP-1药丸引起的。

The danuglipron program's termination is disappointing, but it won't be the end of Pfizer's attempt to develop blockbuster weight-management drugs. The company has an oral glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist in phase 2 trials. Investors will probably hear more about this candidate, tentatively named PF-07976016, down the road.

Danuglipron计划的终止令人失望，但这并不是辉瑞公司试图开发大型体重管理药物的终结。该公司在2期试验中具有口服葡萄糖依赖性胰岛多肽受体（GIPR）拮抗剂。投资者可能会听到有关这位候选人的更多信息，该候选人暂定地命名为PF-07976016。

Bigger problems

更大的问题

A disappointing outcome for a weight-management candidate isn't anywhere near the top of Pfizer's list of problems. Investors should be far more concerned with an upcoming loss of patent-protected market exclusivity for Eliquis. Sales of the oral blood thinner it markets in partnership with Bristol-Myers Squibb (NYSE:BMY) rose to $7.4 billion, or 11.6% of total revenue last year.

对体重管理候选人的令人失望的结果并不是辉瑞队问题列表的顶部。投资者应该更关心即将到来的Eliquis损失专利保护的市场独占性。与Bristol-Myers Squibb（纽约证券交易所：BMY）合作的口腔血液稀薄IT销售销售额上升至去年总收入的11.6％。

Eliquis is expected to lose patent-protected exclusivity in 2026, although generic competition in the U.S. market isn't expected to begin until 2028. Pfizer's second-largest revenue stream in 2024 could also start drying up soon. The Prevnar family of vaccines was responsible for over 10% of total sales last year. Prevnar 13 is expected to lose patent-protected exclusivity in the U.S. next year.

预计Eliquis将在2026年失去专利保护的排他性，尽管预计在2028年才开始美国市场的通用竞争。辉瑞在2024年的第二大收入流也可能很快开始枯竭。 Prevnar疫苗家族造成了去年销售总额的10％以上。预计明年在美国，PREVNAR 13将失去受专利保护的排他性。

Vyndaqel has been a strong growth driver for Pfizer but probably not for much longer. This treatment prevents heart damage caused by transthyretin (TTR) amyloidosis and grew sales by 64% to reach $5.4 billion last year. Bridge Bio (NASDAQ:BBNG) and Alnylam (NASDAQ:ALNY) are now marketing competing treatments for the limited population of TTR amyloidosis patients with heart damage. In addition to competing treatments, Vyndaqel is expected to face generic competition in the U.S. in 2028.

Vyndaqel一直是辉瑞的强劲增长驱动力，但可能没有更长的时间。这种治疗可防止由甲状腺素蛋白（TTR）淀粉样变性引起的心脏损伤，去年销售额增长了64％，达到54亿美元。 Bridge Bio（NASDAQ：BBNG）和ALNYLAM（NASDAQ：ALNY）现在正在为有限的心脏损伤TTR淀粉样变性患者人群营销相互竞争的治疗方法。除了竞争性治疗外，Vyndaqel预计将在2028年在美国面临通用竞争。

Industrywide crisis ahead?

未来的整个行业危机？

Drug developers need to communicate with regulators at the Food and Drug Administration (FDA) before, during, and after they run clinical trials for new drug candidates. In the U.S., many of those regulators recently lost their jobs.

药物开发人员需要在对新药候选人进行临床试验之前，期间和之后与食品药品监督管理局（FDA）的监管机构进行沟通。在美国，许多监管机构最近失业了。

In 2024, the FDA's Center for Drug Evaluation and Research (CDER) approved 50 new drugs. The CDER director, Patrizia Cavazzoni, M.D., stepped down in January and joined Pfizer's C-suite as chief medical officer.

2024年，FDA的药物评估与研究中心（CDER）批准了50种新药。 CDER董事Patrizia Cavazzoni医学博士在一月份辞职，并加入了辉瑞队的C-Suite，担任首席医疗官。

Having the former CDER director on staff could be advantageous for Pfizer, but I'll be pleasantly surprised if the FDA completes new drug approvals at half the usual pace this year. According to reporting from STAT, more than a few FDA employees involved in the new drug approval process were among thousands recently fired from the agency.

拥有前CDER董事对辉瑞公司可能是有利的，但是如果FDA在今年的一半速度下完成新的药物批准，我会感到惊喜。根据STAT的报道，该机构最近被开除的成千上万的FDA员工在新药批准过程中。

A crippled FDA could be a huge problem for Pfizer and its peers who must constantly launch new drugs to overcome exclusivity losses for established products.

对于辉瑞及其同龄人来说，残废的FDA可能是一个巨大的问题，他们必须不断推出新药以克服已建立产品的排他性损失。

A buy on the dip

蘸酱购买

Many investors expect pharmaceutical industry lobbyists to prevent the Trump administration from rendering CDER incapable of reviewing new drug applications at its usual pace. They could be right, but I won't support an investment thesis that relies on industry lobbyists protecting a regulatory agency.

许多投资者希望制药行业游说者阻止特朗普政府使CDER无法以通常的速度审查新药应用。他们可能是对的，但我不支持依靠保护监管机构的行业游说者的投资论文。

If you asked me a month ago, I would have called this stock a buy. In 2023, it earned FDA approval for nine new drugs and last year it reported over a dozen product approvals from the agency. With plenty of new products coming online, Pfizer had a good chance to overcome upcoming patent cliffs and maintain its dividend-raising streak

如果您一个月前问我，我会将这款股票称为购买。 2023年，它获得了FDA的九种新药的批准，去年报告了该机构的十二种产品批准。随着许多新产品的上网，辉瑞公司有一个很好的机会克服即将到来的专利悬崖并保持其股息提高连胜纪录