Obesity Drugs Offer Challenges --- Novo Nordisk, Eli Lilly are working to increase capacity, insurance coverage

"New drugs that help people shed pounds are all the rage. Everyone from Hollywood celebrities to Elon Musk is trying out these medications -- which were first approved to treat diabetes -- even if it means going off-label.

Whether the leading companies making this new class of drugs known as GLP-1s can keep up with demand and convince insurers of the wider benefit to patients' health is now a closely watched question. Shares of Eli Lilly and Novo Nordisk, the two leading manufacturers of these new drugs, were both down on Thursday as Lilly's financial results came in short of hyped-up expectations.

Lilly on Thursday reported that Mounjaro, which is currently approved for diabetes only, notched sales of $279 million for the fourth quarter, shy of the $288 million estimated by analysts on Visible Alpha. Mounjaro is now covered for slightly more than 50% of people insured by companies or Medicare, which is "up only marginally from 45% disclosed in 3Q results slides," SVB Securities analyst David Risinger wrote. Lilly is hoping to obtain Food and Drug Administration approval for the use of the same compound against obesity this year.

Lilly's numbers weren't bad, but investors are jittery after both Novo Nordisk and Lilly had phenomenal stock runs. Shares of Novo Nordisk have doubled in two years, making it the most valuable drug company in Europe. Lilly is up more than 50% in that period and is now the most valuable one in the U.S. excluding Johnson & Johnson. Both Lilly and Novo Nordisk trade at sky-high price/earnings multiples compared with their pharma peers. The updates from the companies have been mostly enthusiastic. Novo Nordisk said on Wednesday that obesity-drug sales doubled in 2022, with its newest drug, Wegovy, reaching about $900 million.

For now, pent-up demand means patients are moving faster than the healthcare system can bear. Both companies are scrambling to increase supply. Novo Nordisk executives said Wednesday that the company is facing capacity constraints that are unlikely to abate soon. To address this, Novo Nordisk plans to increase capital expenditures to about $3.7 billion in 2023, executives said. Lilly said Thursday it is making $3.3 billion in investments in manufacturing sites this year, creating a "substantial expansion of capacity" to support drugs such as Mounjaro.

The supply shortages are easing. Novo Nordisk said in late December that all Wegovy dose strengths had been made available again in the U.S. in December.

The bigger, more challenging question is who is going to pay as demand skyrockets. Novo Nordisk's obesity drug is expensive, costing more than $1,000 a month, and it still isn't widely covered. The company said Wednesday that of about 110 million Americans suffering from obesity, 40 million now have access to Wegovy, with 30 million from the commercial market and 10 million from Medicaid. But one of the largest markets -- seniors -- depends on Medicare, which still doesn't cover anti-obesity drugs.

Both Lilly and Novo Nordisk are working on longer-term studies that they hope will prove to commercial and government insurers that the benefit of these drugs extends well beyond weight loss to other health risks such as sleep apnea, heart failure and kidney disease. Results from a Novo Nordisk clinical trial known as Select will be released sometime midyear. The trial will assess the benefit of its obesity drug semaglutide, the active medicine in Wegovy, for heart disease and stroke.

"We believe positive outcomes data will support the value proposition of obesity therapies to payers," Louise Chen, an analyst at Cantor Fitzgerald, wrote in a report earlier this year, predicting the total opportunity for obesity-drug makers at more than $50 billion in annual sales.

There is certainly a lot of excitement for these drugs. Going forward, anything short of spectacular growth will disappoint investors." [1]

1. Obesity Drugs Offer Challenges --- Novo Nordisk, Eli Lilly are working to increase capacity, insurance coverage
Wainer, David.  Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 03 Feb 2023: B.12.