Looking to avoid a repeat of the shortages that plagued Mounjaro and Zepbound during their initial rollouts, Eli Lilly is building supply of its oral GLP-1 contender orforglipron well before the drug’s expected approval in 2026.
As of Dec. 31, Lilly had amassed pre-launch inventory worth $548.1 million that was “primarily related to orforglipron,” the company said in its annual report issued last week.
“When we believe that future commercialization is probable and the future economic benefit is expected to be realized, we capitalize prelaunch inventory prior to regulatory approval,” the company explained in its securities filing.
Orforglipron is currently in late-stage testing for type 2 diabetes, obesity and obstructive sleep apnea. Unlike Lilly’s injectable GLP-1 currently on the market, tirzepatide, orforglipron is an oral medication.
The drug has already turned in positive phase 2 data in obesity and is expected to deliver phase 3 results in diabetes in 2025’s second quarter, Lilly has communicated. The company ultimately plans to submit regulatory filings for orforglipron toward the end of the year, first in obesity, for a potential approval in 2026.
While it isn’t uncommon for companies to stockpile inventories of promising drugs before launch, the scope and timing of Lilly’s strategic supply is certainly out of the ordinary.
"There have been recent similar pre-launch inventory builds, especially around COVID-19 vaccines, but with the launch not coming until 2026, this earlier-than-normal inventory build is certainly much larger than normal," Kevin Gade, chief operating officer at the investment firm Bahl & Gaynor, told Reuters last week.
Nevertheless, the move tracks with Lilly’s current expectations that it won’t have to gate supplies of orforglipron like it did for its tirzepatide drugs Mounjaro and Zepbound.
“We are building for a full launch in the normal pharma sense,” Lilly’s CEO, David Ricks, said of the decision to build out orforglipron supplies early on the company’s earnings call at the beginning of the month.
Lilly figures it won't have to be conservative with launch supplies of orforglipron, unlike the situation with Mounjaro and Zebpound. For its injectable GLP-1s, which were met with immense mainstream popularity, Lilly had to throttle patient starts to ensure demand didn't outstrip drug inventories, Ricks explained.
Eli Lilly was second to the lucrative GLP-1 market for diabetes and obesity following its chief metabolic medicine rival Novo Nordisk. While Lilly and Novo now have the weight loss scene to themselves, multiple other big-name drugmakers like Pfizer and AstraZeneca—plus a wide array of smaller biotechs—are looking to get in on the action, too.
Still, being firstcomers on the scene came with unique challenges for Novo and Lilly, both of which have struggled to keep adequate supplies of their GLP-1 blockbusters on tap.
Now, after several years spent carrying out multibillion-dollar manufacturing expansion campaigns, both companies have managed to successfully liberate their drugs from the FDA’s shortage roster, with the official resolution of Novo’s semaglutide shortage only declared last Friday.
Lilly’s significant stocking effort with orforglipron is no doubt an attempt to avoid those same pitfalls during the company’s second potential GLP-1 launch.
Regarding weight loss, Lilly in June 2023 unveiled phase 2 data showing orforglipron helped patients with obesity lose up to 14.7% of their body weight at 36 weeks compared to placebo. While those stats are considerably lower than the sort of results offered by injectable GLP-1s, they appear competitive for a potential oral option.
Novo Nordisk, for its part, markets an oral version of its GLP-1 semaglutide as Rybelsus, though the drug is only approved in type 2 diabetes.
Meanwhile, Evercore ISI analyst Umer Raffat said he figures Lilly’s $548.1 million in orforglipron inventory could work out to $10 billion in sales, according to Reuters. The company is likely to further build out its inventory before launch, too, Raffat added.