Eli Lilly GLP-1 pill Foundayo approved for obesity

The U.S. Food and Drug Administration approved Eli Lilly‘s GLP-1 pill, the company said, a major milestone for the Indianapolis-based drugmaker and one that will test the market for new weight-loss medications.

Lilly said the once-daily pill, Foundayo, will start shipping from direct-to-consumer platform LillyDirect on Monday and will be available at pharmacies and on telehealth platforms “shortly after.” People with insurance coverage could pay $25 a month with a coupon from Lilly, while people paying out of pocket could pay between $149 and $349, depending on the dose.

The approval comes just a few months after Lilly submitted the drug to the FDA as part of a program that grants speedy reviews for drugs that are considered national priority interests. That means Lilly will introduce its Foundayo only about three months behind Novo Nordisk’s Wegovy pill, setting the stage for the next battle between the rival drugmakers in the next frontier for GLP-1 drugs.

“It’s a big moment,” Eli Lilly CEO Dave Ricks said in an interview with CNBC. “We’ve obviously been working in this category of medicines for a while with the first GLP-1 medication 20 years ago and improving ever since. Here is an option that’s not more effective … but it’s more accessible, it’s easier to fit into your daily routine.”

Lilly licensed the molecule, orforglipron, from Japanese drugmaker Chugai in 2018, paying just $50 million upfront for global rights to the drug. It doesn’t produce as much weight loss as Lilly’s best-selling shot Zepbound, which raises questions about how big the drug will become when millions of people seem content injecting themselves once a week.

Analysts estimate Foundayo sales will reach $14.79 billion by 2030, according to FactSet. That compares to expectations of $24.68 billion for the weight-loss drug Zepbound and $44.87 billion for Mounjaro, which is marketed for diabetes in the U.S. and obesity and diabetes in the rest of the world.

Ricks said shots haven’t been as big of a barrier to uptake as Lilly once thought they would be. He still sees Foundayo as an attractive option for people who would rather take a pill or who are searching for a lower price than the injectables.

He sees it playing a role in maintenance, for people who achieve their goal weight with a shot and want to keep the weight off. And he sees Foundayo as a way to “reach the planet” without manufacturing constraints or cold-chain requirements that come with Zepbound.

Foundayo is a small molecule whereas Zepbound and Wegovy are peptides, which require more intensive manufacturing processes, a barrier Ricks thinks will hinder generic versions of Wegovy that have recently launched in some other countries like India.

“[Foundayo] does allow for scalability, and that will allow us to launch this globally on the first instance,” Ricks said. “So today, you can get the oral [Wegovy] in the U.S., but you really can’t get it elsewhere. This will be marketed around the world. As soon as we have regulatory approvals, we essentially have as much scale as we need to supply the world with an oral GLP-1 inhibitor.”

Lilly expects approval for Foundayo in more than 40 countries over the next year. The company since 2020 has invested more than $55 billion in manufacturing, which includes opening new sites and expanding existing plants to produce the pill.

In the U.S., Lilly will compete with Novo’s newly launched Wegovy pill. Early demand for that pill has been stronger than expected, with Novo reporting more than 600,000 prescriptions in March.

Novo CEO Mike Doustdar told CNBC in February that one of the earliest takeaways from the launch is that the pill appears to be expanding the obesity treatment market, drawing in new patients rather than converting existing ones from injections. Ricks agreed with that assessment and said Lilly doesn’t care whether people take Foundayo or Zepbound.

“We want people to be on the medicine that meets their health goals,” Ricks said. “If it has Lilly on the box, that’s the goal we have.”

Novo plans to argue that the Wegovy pill is more effective than Foundayo. The Wegovy pill showed around 16.6% weight loss on average in a late-stage trial, while Lilly’s oral drug caused roughly 12.4% on average in a separate study, when analyzing patients who stayed on treatment. Lilly’s Zepbound has consistently shown it can help people lose more than 20% of their body weight.

Meanwhile, Lilly plans to tout the fact that Foundayo can be taken any time without any restrictions, while the Wegovy pill needs to be taken first thing in the morning on an empty stomach with only a few ounces of water.

Where the two drugs are the same is the starting price. The lowest doses of both drugs will cost $149 for cash-paying customers thanks to an agreement the companies struck with the Trump administration last fall. And price is the most important factor for patients, said Dr. Nidhi Kansal, an obesity medicine doctor at Northwestern Medicine.

“Unfortunately, price is what is driving the decision making between clinicians and patients for these drugs because they’re all excellent drugs and we have lots of options now, but it’s still a financial decision at the end of the day,” Kansal said.

The lower price point and the approachability of a pill versus a shot opens up the market to casually interested patients, said BMO Capital Markets analyst Evan David Seigerman. Seniors on Medicare will be able to access Foundayo and other GLP-1 obesity medicines for $50 a month starting this summer as part of Lilly and Novo’s deals with the Trump administration. Ricks expects a “pretty robust” response to the program, which Lilly built into its financial guidance for the year.

Analysts say a successful launch of Foundayo is key to Lilly’s stock recovering from recent weakness. The company’s shares have fallen about 14% this year after a meteoric rise that briefly made Lilly the first trillion dollar market cap health-care company. Sales are a lagging indicator, so analysts will be tracking prescriptions to monitor uptake of the pill, said Cantor Fitzgerald analyst Carter Gould.

“If scripts are going in the right direction, and you’re seeing the continued gains, my guess is people will look through any sort of choppiness around [the first or second quarter],” Gould said.

Another factor for Lilly’s performance this year is a forthcoming readout for its more potent obesity shot, retatrutide. The company has already shared some late-stage data on that drug, but the most important trial is one studying the treatment specifically for weight loss. If retatrutide lives up to its expectations, Lilly would be on its way to creating a portfolio of obesity medicines.

“The future will be more choices, and that’s a great thing,” Ricks said. “And we hope Lilly is the one presenting those choices.”