Add Novo Nordisk in paragraphs 5-6; analyst in paragraph 7-8, lawyer in 12-13;

By Amina Niasse

NEW YORK, Feb 5 (Reuters) - Online telehealth company Hims and Hers Health HIMS.N on Thursday began offering a much cheaper $49 compounded version of Novo Nordisk's NOVOb.CO new Wegovy weight-loss pill in a move that expands sales to many Americans but could undercut Novo's and Eli Lilly's LLY.N plans for the consumer market.

The news touched off a swift reaction on Wall Street as investors sold off Novo and Lilly shares, and the Danish drugmaker promised a legal challenge to the move by Hims.

Novo shares fell 8.6%, while Lilly was off LLY.N 6%.

Hims said the $49 one-month introductory price will rise to $99 per month for those who purchase a five-month plan and pay upfront. The monthly price is higher for a three-month subscription. Novo plans to charge $199 for its oral Wegovy, with no subscription.

The announcement comes as Novo warned on Wednesday that pricing pressure was unprecedented for its weight-loss medicines and dropped its full-year forecast. Novo shares on Thursday hit their lowest level since July 2021.

Novo spokeswoman Ambre James-Brown said only the Danish drugmaker can sell the Wegovy pill with its unique technology that allows absorption of the medicine.

"The action by Hims & Hers is illegal mass compounding that poses a significant risk to patient safety. Novo Nordisk will take legal and regulatory action to protect patients, our intellectual property and the integrity of the U.S. gold-standard drug approval framework," she said.

Hims had been allowed by the U.S. Food and Drug Administration to sell versions of Novo's GLP-1 injectible drugs while the branded medicines were in short supply. Since then, it has made "personalized" copies of the branded drugs at different doses or regimens than those available from Novo and other drug companies.

"The status quo for months now has been a compounder can create a copycat version of a branded drug, so long as they make some kind of minor tweak that they believe or they argue benefits specific patient groups," said TD Cowen analyst Michael Nedelcovych.

HIMS MAKES CASE FOR MORE CHOICE

Hims said the treatment can be tailored for patients aiming to mitigate side effects or who prefer a pill over the injectable option. Semaglutide is the main ingredient in the new Wegovy pill as well as injectable Wegovy and Ozempic.

"We're excited to find ways to continue bringing branded treatments to the platform across specialties. More choice on the platform is the best thing for customers everywhere," said Hims CEO Andrew Dudum in a statement.

By tailoring its offering for patients with side effects or an aversion to needles, Gaston Kroub, a patent lawyer in New York, said Hims is positioning the oral product as another personalized option, widening the scope of personalization under the FDA’s framework.

"HIMS has shown a willingness to go as close to the line as possible,” he said. “It’s a strategy of saying, ‘All right, if we pop our head over the barbed wire fence, is anybody going to take a shot?’”

Novo launched the drug in the beginning of January and has seen strong demand in the U.S., where it is available on its cash-pay direct-to-consumer website.

Novo Chief Financial Officer Karsten Munk Knudsen told Reuters in an interview on Wednesday that the drugmaker is still frustrated that "mass marketing of a product unapproved by the FDA" is continuing, and said it was up to the U.S. regulator and politicians to address this. "Predicting if and when the tide turns is really hard," Knudsen said, referring to the compounding market.

NOVO HISTORY WITH HIMS

In addition to U.S. pricing pressure, Novo is girding for competition from Eli Lilly on the oral weight-loss front as the Indianapolis-based drugmaker expects to launch its own pill in the second quarter.

Novo and Hims had a partnership in 2025 allowing the telehealth company to offer injectable Wegovy, but the two companies walked away with Novo saying Hims had wrongfully marketed versions of its medicine.

Dudum accused Novo of attempting to control how clinicians at Hims make decisions.

Compounding, in which pharmacies mix ingredients for specialized medicines or to copy a drug but at different dosages, is allowed in the U.S. when it is personalized for a patient. The practice is flourishing even as copies of the branded version are now readily available.

The FDA in September issued a warning to Hims regarding its marketing of compounded semaglutide, stating claims like "same active ingredient as Ozempic and Wegovy" are misleading, as compounded drugs are not FDA-approved.

In 2025, Hims doubled the size of its facility in New Albany, Ohio. The company said on Thursday the expansion allows Hims to provide treatments at a lower price.