Lilly CEO says weight-loss drug shortage to end ‘very soon’

Indianapolis-based Eli Lilly and Co. expects its blockbuster weight-loss drug to officially come out of shortage in the United States in the coming days, the company’s CEO said, threatening the billion-dollar industry of copycat versions of the in-demand drugs.

Lilly’s drug, sold for weight loss as Zepbound, will cease to be in shortage “very soon,” CEO David Ricks said in an interview in Paris on Thursday. “I think actually today or tomorrow we plan to exit that process.”

Lilly’s drug, tirzepatide, sold as Mounjaro for diabetes and Zepbound for weight management, has been racking up huge sales. Mounjaro sales were $1.8 billion in the first quarter and Zepbound sales were $517 million. Zepbound received FDA approval in November.

The news sent Lilly stock up nearly 4% on Thursday and shares of copycat drug maker Him & Hers Health Inc. plummeting more than 12%.

When pharmaceuticals are in shortage, the FDA allows pharmacies to make compounded, or copycat, versions of the drug. Him & Hers is among the companies that rushed into selling copycat versions of Lilly and Nov Nordisk weight-loss drugs.

Meanwhile Thursday, Lilly announced that Zepbound improved the long-term health of patients with obesity-related heart failure in a study, illuminating the cardiovascular benefits of the weight-loss shot.

The risk of death, hospitalization and other bad outcomes was 38% lower in patients given Zepbound compared to those who received a placebo, Lilly said. The drug also significantly reduced heart failure symptoms, including shortness of breath, fatigue and an irregular heartbeat.

The two-year trial involving more than 700 patients is part of Lilly’s broader effort to prove that Zepbound, already in high demand for its effects on body weight, can do more than just shrink waistlines. Growing evidence that it improves key components of health may also help the company get insurers to pay for it.

“That’s what we need to get, not only recognition of the seriousness of the disease, but also reimbursement access,” Jeff Emmick, Lilly’s senior vice president of product development, said in an interview.

The approach seems to be working.

“We see today’s data supporting additional coverage of the product in Medicare patients, prior to broader obesity coverage, as well as providing a strong case for commercial coverage of the drug,” wrote Chris Schott, an analyst at JPMorgan, in a note to investors.

The company plans to submit results to regulators in the US and abroad later this year, seeking to expand Zepbound’s label. The study involved heart failure patients with a preserved ejection fraction, or HFpEF, a condition closely linked to obesity.

The disease occurs when the heart muscle stiffens, preventing it from filling with enough blood. It affects about 3 million people in the U.S. and as many as 32 million globally, with an annual mortality rate of about 15%, according to a review published last year in the medical journal JAMA.

Novo Nordisk is ahead of Lilly in the race to prove weight-loss drugs can help the heart. Its drug Wegovy was approved for patients with cardiovascular disease in March after a trial showed it cut the risk of heart attacks and strokes by 20%.

That opened the door for Medicare, the government health program for those over 65, to start covering it for more patients. In January, Novo asked regulators to add heart failure to Wegovy’s label after studies showed it improved symptoms.

Lilly has other trials in cardiovascular disease that are still ongoing and results aren’t expected for at least another year.

In the meantime, the company is focused on getting Zepbound approved for patients with sleep apnea. It’s also studying other conditions like a common liver disease called metabolic dysfunction-associated steatohepatitis, or MASH.

Lilly shares were down 4.4% Friday, to $795.45 each, with the stock market possibly having its worst day in two years.