Novo Nordisk to 'significantly' boost U.S. Wegovy doses next year

By Jacob Gronholt-Pedersen and Maggie Fick

COPENHAGEN (Reuters) - Novo Nordisk said on Thursday it will supply "significantly" more doses of Wegovy in the U.S. next year, even as it cautioned shortages of the weight-loss injection would continue in the short to medium term.

The Danish drugmaker, which this year overtook LVMH as Europe's most valuable listed company, posted record operating profit and sales for the third quarter, underscoring the phenomenal success of Wegovy so far.

"Specifically on the U.S. market, we'll be supplying significantly more in 2024 compared to what we are in 2023," Novo's CFO Karsten Munk Knudsen said in an interview.

Novo has struggled to keep up with soaring demand for the appetite-suppressing anti-obesity drug, and has limited the number of U.S. patients who can start treatment since May.

"Given the unmet need in society for safe and efficacious obesity treatments, we will not be able to supply to the full global market for a number of years," Knudsen said.

Novo shares were trading 1.6% higher at 1038 GMT, even as investors and analysts had hoped for clarity on when limits on the supply of Wegovy starter doses in the U.S. would cease.

The company's CEO Lars Fruergaard Jorgensen did not give an end-date and declined to give details on manufacturing when asked on a media call.

"We don't see a 'hockey stick' development where suddenly there'll just be a significant ramp-up in sales," he said, indicating that manufacturing would ramp up gradually.

The company still plans to contract a third manufacturer this year to help produce Wegovy, Knudsen said.

It also said in its quarterly earnings statement that in September and October it had submitted applications to U.S. and European Union authorities for Wegovy to be approved to reduce the risk of cardiovascular events.

That followed results of a large study released in August that showed Wegovy had a clear cardiovascular benefit, boosting the Danish company's hopes of moving beyond its image as a lifestyle drug.

The U.S. Food and Drug Administration had granted priority review for the application, Novo said.

"(It's) slightly negative that Wegovy is still supply restrained," said Markus Manns, a fund manager at Union Investment and a Novo shareholder.

However, the decision to fast-track Novo's application in the U.S. was positive, he said.

SUPPLY ISSUE IN FOCUS

Wegovy sales totalled 9.6 billion Danish crowns ($1.36 billion) between July and September, up 28% from the previous quarter and eight-fold from the same period last year.

In August, Novo said the curbs on Wegovy supplies would most likely extend into 2024.

Investors and analysts have called for clarity on when the supply issue would be solved, as rival Eli Lilly expects U.S. approval of its Mounjaro weight-loss drug later this year.

The company also said U.S. prescription volumes for GLP-1 class, its hugely popular weight loss and diabetes drugs, grew by 50% in the quarter compared to last year.

Last month Novo raised its full-year sales and operating profit guidance for the third time this year, reflecting strong demand for Wegovy and diabetes medication Ozempic in the U.S.

Sales grew 29% year-on-year to 58.7 billion Danish crowns, while operating profit (EBIT) rose 33% to 26.9 billion, both in line with preliminary numbers released last month.

($1 = 7.0443 Danish crowns)

(Reporting by Jacob Gronholt-Pedersen; Editing by Terje Solsvik, Shri Navaratnam, Emelia Sithole-Matarise and Jan Harvey)