Novo Nordisk sees ‘uncertainty’ in Wegovy supply in the coming months as it provides insight on manufacturing plans

Despite Novo Nordisk initially suggesting its US supply shortage for Wegovy would ease in September, it is now saying such constraints may carry on a bit longer.

Karsten Munk Knudsen

The company had put on its website that US patients may have difficulty filling their prescriptions for certain doses of Wegovy “through September.” However, on a media call Thursday, CFO Karsten Munk Knudsen said that the restriction on starter doses may be extended for the “coming quarters.” Demand is so high, he said, that there is “inherent uncertainty to the pace of the obesity care market expansion.”

But this should not be read as “uncertainty on the supply side — but more that we will be navigating the market in a sustainable manner,” Knudsen added on its separate second quarter earnings call. “The starter dose in the US will be managed more and more dynamic in terms of how many we start given the [availability] fluctuations between the dose strengths,” he explained.

The FDA has listed Wegovy, or semaglutide, as being in short supply in the 0.25 mg, 0.5 mg and 1 mg dosage amounts. These are the starting doses as current treatment requires patients to start at the 0.25 mg dose and then increase the dosing every four weeks until a patient reaches the full dosing amount at 2.4 mg.

Knudsen said the company expects continued periodic supply constraints and Wegovy-related shortage notifications. Supply of the Wegovy lower dose strengths in the US will be restricted “to safeguard the continuity of care” while Novo continues to ramp up supply capacity.

“There are some uncertainties about what dose strengths are being utilized in the specific markets,” he added. As such, the best way to ensure patient safety and experience is to “not start more patients than we can secure continuity of care. And, furthermore, not to launch in more affiliates than we can support,” he said.

Novo underscores expansion strategy

Novo Nordisk has a supply plan to increase its scale and meet demand and is working to get new manufacturing lines on track, Knudsen said. The company started with one contract manufacturing filling line this year, which expanded to a second line, he noted. The company is now on track to add a third, with another to be added in 2024.

This is a “significant step up in capacity and time,” Knudsen said. To meet European demand, it is also working on its in-house cartridge filling and fixers. “We are building optionality in terms of how to deploy moving forward,” he stated, adding that scaling Wegovy is a “top priority” due to unmet need.

Filling lines are dedicated to physically filling the drug into a syringe or a delivery device and are being done by Novo and other companies contracted by the Danish drugmaker.

Further, Knudsen noted that Wegovy’s increase in sales “speaks to the scalability” that the company is doing to secure active pharmaceutical ingredients (API). “We’re scaling our API setup significantly and a key part of our 25 billion kroner capex program this year goes into peptide API, which most likely will be multi-use and hence also cater for semaglutide manufacturing in years to come,” he added.

In Q2, Novo pulled in DKK 99 billion ($14.6 billion) from its obesity and diabetes sector thanks to drugs such as Wegovy and Ozempic. Overall the company reported a revenue north of DKK 107 billion ($15.8 billion).

When asked about potentially changing its administration method to meet demand, Knudsen said it had no current plans to do so. At present, the US version is administered via a single-use pen called FlexPen, while patients in other countries use a FlexTouch pen, which can contain multiple doses.

Meanwhile, Novo Nordisk’s total sales in its rare disease portfolio dropped by 18%, driven by a 17% dive in its international operations and an 18% slide in North America. Notably, its endocrine disorder sales were affected by a “temporary reduction” in manufacturing, Camilla Sylvest, Novo’s EVP of commercial strategy and corporate affairs, said. According to Doug Langa, Novo’s EVP of North American operations, sales for its growth hormone therapy Norditropin were particularly impacted by such manufacturing reduction.

On the media call, Martin Holst Lange, EVP of development, said the temporary reduction was due to a delay in moving the production of growth hormones from one factory to another.

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