Hims & Hers Health 株価急落 – ブランド減量薬の代替品禁止が影響
本文
Hims & Hers Health（HIMS）の株価が23%以上急落した。
主因は、調剤GLP-1製品に依存する企業の将来性に対する市場の懸念である。特に、米国食品医薬品局（FDA）が減量薬オゼンピック（Ozempic）およびウェゴビー（Wegovy）の有効成分セマグルチドの供給不足が解消されたと発表したことが大きく影響した。この発表により、同社も開発、販売を行っている高価な減量薬の代替品としての調剤セマグルチド注射製品の製造・販売が禁止され、Hims & Hersの製品供給に打撃を与えることが懸念された。
もともと調剤GLP-1薬剤はFDAの正式承認を受けておらず、安全性や品質管理の問題が指摘されていた。一部の調剤薬では不純物の混入や投与ミスのリスクが報告されており、規制強化の要因となった可能性がある。短期的には、過去12か月で約8,000万件の調剤セマグルチド処方があったが、今後はFDA承認薬への移行が求められることでHims & Hersの収益減少が予想される。また、投資家が期待していた代替品ビジネスの縮小により、株価のボラティリティが高まる可能性がある。
ただし、同社の株価はこれまでTrybe Labsの買収による検査プラットフォーム化や、テレヘルス分野でのポジショニング、ブランド薬の手頃な代替品への期待によって急上昇してきた経緯がある。
業界としては今後、FDA承認薬への移行が進み、ブランド薬の需要が増加することで、製薬業界全体にも影響を与えると考えられる。
English
The stock price of Hims & Hers Health (HIMS) has plunged by more than 23%.
The primary reason for this decline is market concerns about the future of companies that rely on compounded GLP-1 products. In particular, the announcement by the U.S. Food and Drug Administration (FDA) that the supply shortage of semaglutide, the active ingredient in the weight-loss drugs Ozempic and Wegovy, has been resolved had a significant impact. This announcement effectively bans the manufacturing and sale of compounded semaglutide injection products, which had been distributed as a high-cost alternative weight-loss drug, raising concerns about its impact on Hims & Hers' product supply.
Compounded GLP-1 medications have never received formal FDA approval, and concerns regarding safety and quality control had been pointed out. Some compounded drugs have been reported to contain impurities or pose risks of dosing errors, which may have contributed to regulatory tightening. In the short term, there have been approximately 80 million prescriptions for compounded semaglutide over the past 12 months. However, with the shift toward FDA-approved drugs, Hims & Hers is expected to experience a decline in revenue. Additionally, the contraction of the alternative drug business, which investors had anticipated, could lead to increased stock price volatility.
That said, Hims & Hers' stock had previously surged due to its acquisition of Trybe Labs, which enabled the company to build a home testing platform, its strong positioning in the telehealth sector, and expectations for affordable alternatives to branded medications.
For the industry as a whole, the transition to FDA-approved drugs is expected to accelerate, leading to increased demand for branded medications, which could have broader implications for the pharmaceutical sector.
参考
https://www.fiercehealthcare.com/health-tech/fda-declares-semaglutide-shortage-over-spelling-end-compounded-glp-1-market
https://www.investing.com/news/stock-market-news/hims--hers-health-stock-falls-as-fda-ends-drug-shortage-93CH-3883857
https://www.fiercehealthcare.com/health-tech/hims-hers-sees-650-spike-traffic-following-super-bowl-ad-clash-over-compounded-glp-1s
https://www.livescience.com/health/medicine-drugs/hims-and-hers-super-bowl-controversy-what-the-ad-left-out-about-its-alternative-weight-loss-drugs
Hims & Hers Super Bowl Ad Raises Controversy Over FDA Regulatory Compliance
https://medcitynews.com/2025/02/compounded-glp1-safety/
Are Compounded Versions of Popular Weight Loss Drugs Safe?
https://www.hilliard-law.com/blog/2025/january/the-dangers-of-compounded-semaglutide-the-effect/
https://news.northwestern.edu/stories/2025/02/complicated-compounded-weight-loss-drugs/
Hims & Hers Health (NYSE:HIMS) Climbs 60% Despite Market Volatility
https://www.forbes.com/sites/greatspeculations/2025/02/21/hims-stock-is-the-risk-worth-the-reward/