Hims & Hers Faces Regulatory and Legal Setbacks

Hims & Hers US4330001060

The telehealth company Hims & Hers is confronting significant challenges from two major fronts: regulatory action and intellectual property litigation. These events have sent its equity value tumbling, with shares now trading close to their lowest point in the past year.

All eyes are now on the company's upcoming financial report. Hims & Hers is scheduled to release its fourth-quarter 2025 results on February 23. Market experts are forecasting earnings per share of $0.04 on revenue of approximately $619.5 million. This would represent continued growth from the third quarter, where the company posted $599 million in revenue?a 49% year-over-year increase. Its subscriber base has also expanded, reaching nearly 2.5 million users.

Management has previously taken steps to bolster investor confidence. In November 2025, the board authorized a $250 million share repurchase program. The company also strengthened its regulatory expertise by appointing Deb Autor, a former FDA official, as its Chief Policy Officer. Whether these fundamental strengths can restore market trust remains to be seen.

FDA Crackdown Halts Key Product Line

The pressure began in early February 2026 when the U.S. Food and Drug Administration (FDA) announced decisive measures to restrict the distribution of unapproved GLP-1 agonists. The agency explicitly cited Hims & Hers, which had been actively marketing lower-cost alternative compounds to expensive weight-loss drugs like Ozempic.

The company's response was swift. By February 7, Hims & Hers withdrew its recently launched semaglutide pill from the market. This product had been positioned as a substantially more affordable option compared to traditional branded medications.

Pharmaceutical Giant Files Patent Lawsuit

The situation escalated just two days later. On February 9, Novo Nordisk filed a patent infringement lawsuit against the telehealth firm. The Danish pharmaceutical conglomerate alleges that Hims & Hers violated U.S. Patent No. 8,129,343 through its sale of compounded semaglutide products.

Novo Nordisk is seeking a permanent injunction to halt sales, along with monetary damages. In a sharp rebuttal, Hims & Hers labeled the legal action a "brazen attack" on millions of American consumers seeking accessible healthcare options.

Wall Street Strategists Slash Price Targets

The investment community reacted promptly to this one-two punch. Several prominent financial institutions significantly reduced their share price projections for Hims & Hers:

• TD Cowen lowered its target from $30 to $20.
• Citi cut its forecast from $30 to $16.50.
• Deutsche Bank adjusted its target down from $42 to $31.
• Bank of America reduced its estimate from $26 to $21.

Trading activity surged dramatically. On the day of the initial pill announcement, around 69 million shares changed hands, marking the stock's most active trading session since October.