Lilly sales of new diabetes drug accelerate on rising patient demand – BioPharma Dive

The company is working to increase supply of Mounjaro amid a launch Lilly executives described as “unprecedented.”
Eli Lilly’s new diabetes medicine Mounjaro outpaced Wall Street sales forecasts during the third quarter, fueled by strong patient demand and widening insurer coverage.
U.S. sales of the drug totaled $97 million between July and September, Mounjaro’s first full quarter on the market since its May 13 approval by the Food and Drug Administration. Payments related to a collaboration agreement with Mitsubishi Tanabe Pharma in Japan pushed global revenue for the quarter to $187 million, well above the consensus analyst forecast of $82 million.
“We have seen unprecedented demand for Mounjaro’s Type 2 diabetes launch in the U.S.,” said Anat Ashkenazi, Lilly’s chief financial officer, on a Tuesday call with analysts. 
Mounjaro is the first approved treatment of its kind, designed to stimulate two hormones that help control insulin production. In studies of people with Type 2 diabetes, treatment with the drug lowered patients’ blood sugar by more than other diabetes medications, including insulin as well as a competing therapy from rival Novo Nordisk. 
Notably, Mounjaro showed a potent effect in reducing trial participants’ weight, a benefit that was also observed in a large study specifically assessing it as an obesity treatment. While it’s currently only approved to treat Type 2 diabetes, its potential as a medicine for both chronic conditions has made it one of Lilly’s most important products.
Lilly is currently conducting a second study in obesity and plans to complete an approval application in that indication should results, expected in April next year, also prove positive. 
Until Lilly wins approval in obesity, it can’t promote Mounjaro as a weight loss treatment specifically. But its strong study results have driven considerable interest, especially after the FDA’s approval last year of Novo’s drug Wegovy for chronic weight loss. (Sold as Ozempic for use in diabetes, Wegovy stimulates one of the same hormones that Mounjaro does.) 
About two-thirds of the patients prescribed Mounjaro in the third quarter had a history of prior treatment with other Type 2 diabetes medicines, according to Mike Mason, president of Lilly’s diabetes division. The remaining one-third are either newly diagnosed with Type 2 diabetes, or haven’t yet been diagnosed with the condition, said Mason, on Tuesday’s call. 
Demand for Wegovy has been so strong that Novo has had trouble making enough of the drug, leading to supply shortages while it brings online more manufacturing capacity. Lilly is doing the same in anticipation of quickly ramping Mounjaro sales and is building out a large plant in North Carolina that will be operational next year. 
“We’re taking actions to maximize production supply for current facilities, while we ramp up our new manufacturing facility,” said Mason. He added that production might not always meet weekly demand, particularly given the uncertainty around supply of Novo’s competing products.
“This will produce some some intermittent delay in meeting wholesale orders for some dosing strengths as we ramp up our supply chain,” said Mason, who noted the “viral nature” of patient interest in Mounjaro within the diabetes community. 
Mounjaro’s accelerating launch was a bright spot alongside earnings that were clouded by Lilly’s lowering of its financial forecasts for the year. The company now expects $300 million less in annual revenue due to unfavorable foreign exchange rates, and also trimmed its expectations for non-GAAP earnings per share as a result of higher research and development charges. 
Shares ticked down by nearly 5% Tuesday morning in response, cooling a stock run that had pushed its market value to a record high of $344 billion on Monday. 
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Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more.
Prime Medicine is only the third maker of gene-based drugs to go public this year, a significant reversal from the recent peak of 19 in 2021.  
There have been 36 biotech acquisitions worth more than $50 million this year, overtaking last year’s count of 35. However, total deal value is lower, as more deals in 2022 have come at a price of less than $1 billion. 
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