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FDA Uncertainty Pushes Analyst To Lower Hims & Hers Forecast

Novo Nordisk A/S (NYSE:NVO) said on Monday it has filed a lawsuit against telehealth company Hims & Hers Health Inc. (NYSE:HIMS) for infringing U.S. Patent 8,129,343 with compounded semaglutide products for the U.S. market.

• Hims & Hers Health stock is at significant support. What’s pressuring HIMS?

What Happened

Last Thursday, Hims & Hers Health announced an expansion of its weight loss specialty by enabling providers to prescribe a Compounded Semaglutide Pill with the same active ingredient as Novo Nordisk’s Wegovy, at a special introductory offer starting at just $49 for the first month.

Novo Nordisk said that Hims & Hers will unlawfully mass-market an unapproved, inauthentic, and untested knockoff semaglutide pill.

On Friday, Hims & Hers Health decided to cease offering its compounded semaglutide pill.

Year-to-date, HIMS stock has fallen around 46%.

Analyst Cuts Price Forecast

On Monday, BofA Securities reduced the price forecast for Hims & Hers Health from $26 to $21, and reiterates the Underperform rating.

The analyst Allen Lutz sees around 18.5x CY26 EBITDA previously around 21x). Given the growing risk, GLP-1 sales will erode over time, and highlight that it is unclear what the repercussions will be for Hims & Hers.

Analyst Lutz states that the FDA’s statements indicate they could act to restrict GLP-1 active pharmaceutical ingredients (APIs), but did not specify if this applied to oral, injectable products, or both.

Because the FDA did not make a distinction between oral and injectable products, BofA wrote that the update could extend beyond the API for oral GLP-1s and include APIs for Hims & Hers’ injectable semaglutide.

Lower Revenue Projections

This adds a new risk to Hims & Hers’ injectable GLP-1 franchise. BofA estimates that Hims & Hers will generate $825-$850 million of injectable GLP-1 sales in fiscal 2025 at roughly 10% EBITDA margins.

Hims & Hers will report fourth quarter and full year 2025 financial results on Feb. 23, with Wall Street earnings estimates of $2.80 cents per share and sales of $619.73 million.

The management estimated fourth-quarter revenue of between $605 million and $625 million, versus the $631.68 million analyst estimate.

The company narrowed its fiscal 2025 revenue outlook to a range of $2.335 billion to $2.355 billion, versus the $2.341 billion estimate.

BofA lowered GLP-1 revenue estimates by 25% in 2026 to reflect the swiſt uptake of branded oral GLP-1s and growing competition. Analyst Lutz expects significant downside revision risk to the Street’s revenue/EBITDA, even under scenarios where Hims & Hers is able to maintain its injectable GLP-1 franchise.

HIMS Price Action: Hims shares are trading down 18.77% at $18.70 at the time of publication on Monday, as per data from Benzinga Pro.

Photo: Shutterstock

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