Mounjaro's first full quarter beats forecasts as weight-loss interest grows

Eli Lilly's new type 2 diabetes drug Mounjaro brought in $97 million in U.S. sales during the third quarter of 2022, its first full quarter on the market, the company reported on Nov. 1 ^[1]. Counting payments tied to a collaboration with Mitsubishi Tanabe Pharma in Japan, global revenue reached $187 million ^[1]. Wall Street had expected about $80 million: BioPharma Dive cited a consensus analyst forecast of $82 million, while MarketWatch cited a FactSet consensus of $79.0 million ^[1][2]. MarketWatch put total sales at $187.3 million ^[2].

Mounjaro, whose molecule is tirzepatide, was approved by the FDA on May 13, 2022, for type 2 diabetes ^[1]. It is designed to stimulate two hormones that help control insulin production, and in studies of people with type 2 diabetes it lowered blood sugar by more than other diabetes medications, including insulin and a competing therapy from Novo Nordisk, according to BioPharma Dive ^[1].

"We have seen unprecedented demand for Mounjaro's Type 2 diabetes launch in the U.S.," Lilly chief financial officer Anat Ashkenazi said on a call with analysts ^[1].

Much of the attention around the drug comes from its effect on weight. Mounjaro showed a potent effect on weight in diabetes trials, and a large study assessed it specifically as an obesity treatment ^[1]. But it is approved only for type 2 diabetes, so Lilly cannot promote it as a weight loss treatment ^[1]. On the analyst call, Mike Mason, president of Lilly's diabetes division, said about two-thirds of patients prescribed Mounjaro in the quarter had previously taken other type 2 diabetes medicines, while the remaining third were either newly diagnosed with type 2 diabetes or had not yet been diagnosed ^[1]. How many people are using the drug off-label for weight loss has not been disclosed ^[1].

Lilly is working to increase supply of the drug and is building a large manufacturing plant in North Carolina that is expected to be operational in 2023 ^[1]. Mason said production "might not always meet weekly demand," and warned of "some intermittent delay in meeting wholesale orders for some dosing strengths" as the supply chain ramps up ^[1]. He pointed to the "viral nature" of patient interest in Mounjaro within the diabetes community ^[1].

The launch stood out against a mixed earnings report. Lilly cut its annual revenue forecast by $300 million because of unfavorable foreign exchange rates and trimmed its expectations for non-GAAP earnings per share as a result of higher research and development charges ^[1]. Its shares fell nearly 5% Tuesday morning, after the company's market value reached a record $344 billion on Monday ^[1]. The company also said its total U.S. sales of Mounjaro were helped by widening insurer coverage ^[1].

Why it matters for patients

Mounjaro's strong launch is happening while supply of competing weight-loss drugs remains tight. Novo Nordisk has had trouble making enough of its obesity drug Wegovy, which the FDA approved for chronic weight management in 2021, and Lilly is expanding manufacturing in anticipation of its own demand ^[1]. For patients, that means a prescription can be written for a medicine that may not be consistently available in every dose strength ^[1].

Coverage is a separate issue. Mounjaro is approved only for type 2 diabetes, and Lilly cannot market it for weight loss before an approval in that use ^[1]. Whether an insurer pays for the drug when it is prescribed outside its approved use is not addressed in the reported figures, and no data on how many prescriptions were written specifically for weight loss has been disclosed ^[1].

What happens next

Lilly is running a second study of tirzepatide in obesity and plans to complete an approval application in that use if results, expected in April 2023, prove positive ^[1]. The new North Carolina plant is expected to be operational in 2023 ^[1]. Until an obesity approval is granted, the company cannot promote the drug as a weight loss treatment ^[1].