Semaglutide (Thery Pharmaceutical)

Novo Nordisk said on Wednesday that compounding pharmacies’ production of its GLP-1 medicine semaglutide had reduced its market penetration more dramatically than it had expected — causing it to cut its full-year revenue guidance by about three percentage points. The Danish company now expects revenue growth in 2025 to come in at 13-21% at constant exchange rates, down from the 16% to 24% guided to in February. The outlook for Novo’s 2025 operating profit has been reduced by a similar degree. So how did Novo get its initial growth forecast wrong? Part of the answer is that, although semaglutide was taken off the shortage list in February , the ban on compounders producing it does not kick in until May 22 . “When we were out guiding last, we were in a situation where we were moving out of some product shortages in the US that had dampened our growth while compounding picked up,” Novo’s CEO Lars Fruergaard Jørgensen said on a call with media. “This has turned out to be larger than we had anticipated, and I think probably also many others had anticipated.” He added that it was “unprecedented” for large volumes of compounded products to be available. “We have been surprised about the magnitude of that,” he said. The new sales outlook “assumes a reduction in patients on compounded GLP-1 treatment during the second half of 2025,” Karsten Munk Knudsen, Novo’s CFO, said on the call. The rationale behind the tweaked forecast appears to have reassured investors, with Novo’s stock up around 4.5% in early trade on the Danish Stock Exchange. The company recently signed deals with Hims and other telehealth providers to offer official Wegovy instead of compounded versions. Further sales growth could come if Ozempic is approved for the liver disease known as MASH. A regulatory decision is expected in the third quarter of this year. Novo got a recent win in the shape of CVS Caremark, the largest pharmacy benefit manager in the US, choosing Wegovy as the preferred GLP-1 on its template formularies. Jørgensen said Novo did not actively pursue the formulary position, nor did it offer discounts or rebates to secure it. He attributed CVS’ choice to “the benefit of Wegovy, including the cardiovascular benefits.” He declined to say whether other PBMs might make the same decision. He said that there is pressure on PBMs to come up with solutions to the obesity crisis, “and one of the things that sometimes are used as a tactic is exclusivity.” However, he said that there is “low willingness currently by manufacturers to make bids that support exclusivity because it doesn’t really make sense in today’s environment, and this is about growing the market more than, say, cutting the current share of the established business. That’s only a fraction of the opportunity.” He said that more channels were opening up, “like the cash channel, to cater for different patient needs and also some different pricing points, more than, say, exclusive PBM contracts.” Elsewhere, the company has also been offered some reassurance on the US tariffs. “The announced tariffs currently in place do not materially change our financial outlook for 2025,” Jørgensen said. “However, a potential expansion or increase of tariffs may have a negative impact.” Pharma companies have tried to make it clear this earnings season that they are well-positioned to deal with potential sector-specific levies, a situation that is being closely watched by the industry. Jørgensen said that Novo’s once-daily oral form of semaglutide for obesity, which could become the first GLP-1 pill approved for weight loss in the US this year , will be made entirely in the US. “The manufacturing of the active pharmaceutical ingredient, bulk tablet, manufacturing and packaging of oral semaglutide 25 mg are all carried out in the United States.” All the manufacturing steps are up and running, he added. With Eli Lilly’s orforglipron nipping at oral semaglutide’s heels , Novo knows it has to make the most of its first-mover advantage. “When we submit the data to FDA, you can assume that we have what it takes to do a full launch in the US,” Jørgensen said on an analyst call Wednesday. He said that the large amount of safety data the pill has racked up — oral semaglutide has been sold for diabetes as Rybelsus since 2019 — would mean doctors trust the product. “Wegovy in a pill I think is a very attractive offering,”  he said. “We’re ready to give this a big push and … show very strong commercial execution.” However, he said that the oral opportunity “will be way smaller than the injectable segment.” Separately, the company disclosed that it had dropped development of a once-weekly semaglutide pill for diabetes, citing portfolio considerations. It is not clear that there is demand for a pill with that administration schedule, and getting the dosing level right would have been tricky. Editor’s note: This article has been updated with comments from Novo Nordisk’s analyst call.