Eli Lilly is finding itself in an enviable position with its newly launched diabetes injection Mounjaro (tirzepatide) and blockbuster diabetes med Trulicity due to temporary shortages of competitor Novo Nordisk’s diabetes drug Ozempic (semaglutide).
The high demand is attributed to recent off-label prescribing of the drug for weight loss, and viral videos on social media outlets like TikTok that show people, including celebrities, using it to lose weight.
Demand for Lilly’s GIP/GLP-1 receptor agonist Mounjaro is also rising because of high patient demand since the drug’s May 13 FDA approval and expanding insurance coverage. Mounjaro has thus taken off stronger than expected, surpassing Wall Street sales forecasts during the third quarter.
However, it’s uncertain whether Lilly will be able to keep pace with the newfound demand. Although the company is planning to double capacity through a new manufacturing expansion in North Carolina planned for the end of 2023, company executives are warning of supply challenges.
Mounjaro was approved this summer as a Type 2 diabetes treatment and is the first diabetes drug with dual action, targeting two hormones involved in insulin production and appetite (GIP and GLP-1). In contrast, Novo’s diabetes drugs Ozempic and Rybelsus (both semaglutide) are just GLP-1 agonists.
In the third quarter of 2022, Mounjaro scored $187.3 million in global sales, more than double the initial estimates of $81 million. In its first quarter on the market since its approval, sales totalled $97 million between July and September in the US. Lilly reported its stellar earnings in a release this week.
Trulicity also continues to be a stellar performer for Lilly, having garnered $1.85 billion in sales in the third quarter of the year.
Since its US approval in June of last year, demand for Novo’s weight loss drug Wegovy has been skyrocketing, and with a recent informal endorsement from Elon Musk on Twitter, demand is only expected to further increase. Novo has been struggling to keep up with the intense demand for Wegovy, resulting in supply shortages as it works to scale up production capacity.
“We have seen unprecedented demand for Mounjaro’s Type 2 diabetes launch in the US,” said Anat Ashkenazi, Lilly’s chief financial officer, on a call with analysts on Tuesday.
This strong demand has partly been fueled by “limited availability of competitors’ GLP-1s,” said Ashkenazi.
Novo’s Ozempic shortage may also challenge Lilly’s “ability to meet expanding demand [for Trulicity] in most international markets,” Ashkenazi explained.
In addition to the expansion at Lilly’s North Carolina Research Triangle Park, the company expects “additional actions and extensions in other sites” to double the company’s incretin production capacity at the end of next year, she added.
Michael Mason, EVP and president of Lilly Diabetes said Lilly is “taking actions to maximize production supply for our current facilities while we ramp up our new manufacturing facilities,” and will “work hard to avoid or minimize any short-term impact for people living with Type 2 diabetes,” as it builds up its supply chain capacity.
In a head-to-head trial, the results of which helped Mounjaro nab its FDA approval, Mounjaro outperformed Novo Nordisk’s Ozempic in controlling blood sugar and helping patients lose weight.
Lilly is also looking to pitch Mounjaro as an obesity drug and directly take on Novo’s Wegovy. The company is currently conducting a study to demonstrate Mounjaro’s weight loss effects and secured an FDA Fast Track tag in the obesity indication. Lilly plans to begin a rolling submission for Mounjaro in the obesity indication in 2022. The company said it hopes to complete its filing once Phase III data from its SURMOUNT-2 trial starts coming in, which it expects to be in April of next year.