Novo Nordisk to make all doses of its weight loss drug available in the US by end of the year
With production finally up and running for its weight loss drug Wegovy, Novo Nordisk said on Wednesday that it plans to make all dose strengths available in the US by the end of the year.
However, CEO Lars Fruergaard Jørgensen also noted “a bit lower ramp-up versus planned,” as the company’s stock $NVO plummeted more than 12% on Wednesday. Shares were back up 4.6% on Thursday, pricing in at around $104.54 apiece.
“Commercial production at the CMO was reinitiated in the second quarter of 2022 and inventory building is ongoing,” Novo Nordisk’s EVP and head of North America operations, Doug Langa, said on the earnings call.
In December 2021, Novo announced that it did not expect to meet the demand for Wegovy until the second half of 2022 in the US.
Wegovy is an injectable prescription medication for adults who are obese (BMI ≥30) or are overweight (BMI ≥27) and also have weight-related medical problems. It is used with a reduced-calorie meal plan and increased physical activity. The glucagon-like peptide (GLP-1) drug, also known as semaglutide, was approved last June. It’s the same medication as Novo’s type 2 diabetes Ozempic, just at a higher dose.
The shortage was caused by manufacturing issues at a contract manufacturer that was tasked with filling syringes for the pens, the company said in December 2021. Supply quickly sold out after its approval last June, leading Novo to apologize for its inability to meet “unprecedented demand.”
The company wants to ensure “sufficient inventory levels not to disappoint patients and physicians, again,” according to CFO Karsten Munk Knudsen.
“It’s not that we don’t have supply. We keep growing supply to meet a demand that also keeps growing,” Jørgensen said of the potential for further GLP1 shortages. “So from time to time, we’ll have issues in certain markets, but there are products coming in a continuous manner. And we try to manage this, the best we can.”
Back in October, Novo sponsored a marketing campaign featuring actress Queen Latifah to change the narrative around obesity, looking to frame the diagnosis as a manageable health condition.
Meanwhile, Jørgensen had no updates to give on semaglutide’s SELECT trial, assessing the drug’s ability to reduce the risk of cardiovascular events in patients with obesity. The study, which started in 2018 and is currently in Phase III, is expected to be completed by the middle of 2022, said executive vice president, Martin Lange, on the call.
An independent data monitoring committee has conducted an interim analysis and recommended continuation of the trial, Lange said. However, Novo says it hasn’t seen the data.
“We are as confident as we have ever been in terms of reaching the primary endpoint and the purpose of the SELECT trial, because basically all of our assumptions still hold true, and our base case has always been to continue the trial until the end,” he said.
“It’s important to remind you that Novo Nordisk has not seen the data,” he added.
Meanwhile, Novo’s other weight loss drug, Saxenda, is selling at an “all-time high.” Saxenda sales grew 29% in Q2 to about 2.5 billion Danish kroner ($336 million). The drug, approved by the FDA in 2020, is an injection used for obese adults and children aged 12-17 years with a body weight above 132 pounds to help them lose weight and keep it off. It works like GLP-1 by regulating appetite.
“Positively, Saxenda trends have picked up and are now at all-time high levels,” Langa said.
Overall, Novo raked in 18.4 billion Danish crowns ($2.5 billion) in Q2.