Analysis-Hims expansion may not come in time for risky GLP-1 business

By Amina Niasse

NEW YORK, March 2 (Reuters) - Telehealth institution Hims & Hers Health, known for its weight-loss cause business, is promising it tin diversify distant from its reliance connected compounded GLP-1 income successful the U.S., but that whitethorn not hap soon capable for investors who are increasing impatient.

Hims ‌drew regulatory scrutiny past period with its program to motorboat a $49 mentation of Novo Nordisk's brand-new Wegovy pill. It rapidly reversed people aft the U.S. ‌Food and Drug Administration referred the institution to the Department of Justice and threatened to restrict the ingredients that pharmacies premix to marque their compounded versions.

The institution besides disclosed precocious that it learned successful February ​of a U.S. Securities and Exchange Commission investigation.

At the aforesaid time, the institution is facing caller costs from its U.S. concern and enlargement into 8 countries, including the UK and Australia, making it unclear whether it tin conscionable its maturation outlook, 3 analysts said.

The company's CEO, Andrew Dudum, has said that contempt regulatory pressure, it tin prolong its weight-loss business. Dudum said Hims volition set its concern exemplary to conscionable diligent demands, "even successful a draconian script of compounding GLP-1s not being there."

Hims predicted maturation of implicit 15% successful gross successful ‌2026, compared with existent maturation of 59% successful 2025.

Still, pursuing ⁠a league telephone to sermon quarterly results released connected February 23, 4 analysts revised downward their stock terms targets, bringing the mean to $20.70 from $29.42 earlier the call, according to LSEG data. Shares closed astatine $14.52 connected Friday.

"We spot a batch of question marks connected (Hims), including litigation ⁠with Novo Nordisk and imaginable regulatory changes to the compounding industry," said Kadyn Kim, an expert astatine Morningstar.

Novo sued Hims implicit its compounded versions of its Wegovy and Ozempic drugs, made with the progressive constituent semaglutide. Compounders are allowed to marque personalized copies of drugs nether U.S. regularisation but not mass-produce them.

A spokesperson for Hims & Hers did not instantly respond to a petition ​for ​comment.

UNCERTAIN REGULATORY CHANGES AHEAD

Kim said the ongoing conflict betwixt Novo and Hims and the regulatory enactment ​could instrumentality implicit a twelvemonth to resolve.

Hims said successful a filing ‌that it is unclear what actions the regulators whitethorn pursue.

Two manufacture experts said the FDA could adhd semaglutide to its "do-not-compound" list, which limits the instauration of full cause products owed to safety, complexity oregon efficacy concerns.

The regulator could besides update abstracted lists it maintains connected which bulk ingredients are harmless to usage for personalized compounding, which has ne'er been updated to see semaglutide contempt the ingredient's wide use.