Novo Nordisk’s diabetes and obesity sales continue to balloon, though a supply hitch surrounding recent weight-loss launch Wegovy put a slight damper on things. The issue was front-and-center Wednesday as Novo Nordisk talked quarterly earnings and full-year performance on a call with investors.
Still, Novo Nordisk remains confident it can meet U.S. demand for Wegovy in the back half of the year, CEO Lars Fruergaard Jørgensen said throughout the call.
The company in December 2021 said the drug would run short after a contract manufacturer in charge of syringe filling had to halt deliveries over issues with good manufacturing practices. It’s since emerged that the CDMO is Catalent. The manufacturer received a Form 483 after the FDA inspected its Brussels, Belgium, filling plant last October.
Novo and Catalent are making progress toward resolving the issue, Novo Nordisk executives stressed. In the meantime, Novo has reshuffled its own production to help keep supplies afloat.
“Since December, we have worked hard to optimize our internal capacity,” Henrik Wulff, Novo’s executive vice president of product supply, quality and IT, said on the company’s 2021 earnings call Wednesday. “Consequently, we now expect that our internal capacity in the first half of ’22 will be closer to the demand of about 20,000 weekly total [scripts], as seen in the U.S. market at the end of ’21.”
To pull off that supply shuffle, Novo relied on a mix of internal and external capacity, plus a change in clinical timelines. For one, Novo delayed the start of the phase 3 program for its potential weight loss combo therapy cagrisema (cagrilintide and semaglutide) to pivot resources toward Wegovy production, a company spokesperson told Fierce Pharma.
The company has also developed more “clarity” on its internal capacity from December, when it first announced the supply disruption, the spokesperson added. Separately, Novo has been able to release Wegovy batches that had already been produced by its CMO partner prior to the production halt.
When it comes to manufacturing, Novo remains confident in its production partner. “We need to have robust internal capabilities, and we also need to have good partnerships,” Doug Langa, executive vice president and head of Novo’s North American operations, said in an interview. He pointed to Novo Nordisk’s $2 billion API site in Clayton, North Carolina, as well as its recent $2.58 billion investment to build three new manufacturing facilities and expand its site in Kalundborg, Denmark.
Still, the Wegovy issue has prompted Novo Nordisk to put Wegovy sales and marketing activities on hold for the time being, Langa said.
Novo plans to resume those activities in the second half of the year. “We would love to do it earlier, but we need supply certainty,” Langa said. In the interim, Novo will promote its earlier weight-loss med Saxenda, he added. The company is also plotting a direct-to-consumer marketing campaign for Wegovy, which could roll out this year, though timing hinges on the med’s relaunch, Langa explained.
Because of the supply hiccup, Novo also expects to have fewer patient starts on the drug compared to 2021’s fourth quarter, Langa said on Wednesday’s call. Still, Wegovy’s performance so far is promising.
“Despite the supply challenges, the feedback from patients and prescribers continues to be very encouraging, and we remain confident that the long-term potential of Wegovy is unchanged,” he told investors.
Wegovy charts about 22,000 scripts per week, the North American EVP said on the earnings call. More than 70% of those prescriptions come from people who are new to anti-obesity medications, which suggests Novo is making headway on its quest to expand the obesity market, he added.
For 2021, Novo Nordisk garnered net sales of 140.8 billion Danish kroner, a 14% increase over the DKK 126.95 billion it made in 2020. Likewise, sales in North America jumped 14% at constant exchange rates, the company said Wednesday.
Together, diabetes and obesity sales jumped 15% to 121.6 billion Danish kroner. Novo credited those gains to its stable of GLP-1 meds, which grew sales 32% for the year. Novo singled out the momentum behind type 2 diabetes drugs Ozempic and Rybelsus.
Ozempic, for its part, snared 10.72 billion Danish kroner in fourth-quarter sales, marking a whopping 73% year-over-year increase and beating expectations laid out by Jefferies analysts. Rybelsus, Ozempic’s oral counterpart, made 1.8 billion Danish kroner for the quarter, growing 118% over the DKK 835 million it made for the same period in 2020.
On their own, obesity sales rose 55% for the year at constant currencies, failing to beat analysts’ expectations.
Novo is yet to break out Wegovy’s sales figures in its quarterly reporting, but Jefferies analysts predict the drug made about 700 million Danish kroner for the last three months of 2021.
Wegovy was approved in June 2021 as an addition to diet and exercise to help manage weight in obese and overweight patients.
With the hope that Wegovy’s supply woes should be ironed out by the second half of the year, Novo Nordisk is predicting total 2022 sales growth between 6% to 10%.
by Fraiser Kansteiner
Source: fiercepharma.com
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