‘Absolutely dire': How it all went wrong for Ozempic's maker after creating a wonder drug

Sydney Morning Herald

a day ago

Ozempic, which came onto the market in late 2017, led to substantial weight loss and quickly attracted cultural cachet, not least because of its use among celebrities. TikTok videos documenting people's experience with Ozempic attracted millions of views. Analysts predicted that it could tap into an enormous market, since 1 billion people in the world are considered obese. In the first half of the year, Novo Nordisk made $US10 billion in sales from Ozempic, of which 70 per cent was in the United States.
For a company that had been focused on the steady business of selling insulin, the popularity of Ozempic took its executives by surprise. In 2021, they started selling Wegovy, semaglutide marketed specifically for weight loss, but demand was so high that the company struggled to meet it.
That shortage 'opened a whole can of worms', said Rajesh Kumar, an analyst at HSBC.
An FDA decision opens the door for copycats
In 2022, semaglutide landed on the Food and Drug Administration's shortage list, which spurred production of cheaper copycat versions of Novo Nordisk's drugs. To ensure the supply of medicines facing shortages, US federal law allows companies to produce versions of patented drugs via a process of mixing ingredients called compounding.
Loading
The FDA said this year that the shortage was over and ordered producers and sellers of the copycat weight-loss drugs to wind down. But Novo Nordisk said that never happened. Compounders have continued to offer what they call 'personalised' versions of the drugs, a legally murky practice that they claim is allowed by the law.
Novo Nordisk said last week that more than 1 million people were still using compounded GLP-1s, eating into the company's market share and forcing it to slash sales and profit forecasts. Its shares promptly dropped more than 20 per cent, erasing more than $US70 billion ($107 billion) in market value in a day, and some analysts lowered their recommendations on the company.
One of them was Kumar, who had been advising investors to buy Novo Nordisk's shares for at least two years before downgrading last week to 'hold'.
Compounding was part of the reason. 'Novo is issuing a lot of cease-and-desist orders, but it has been very difficult to stop them,' he said, adding he had never seen compounding at this scale before.
On Wednesday, Novo Nordisk said it had filed 14 new lawsuits against compounders the day before. 'It's important that we get compounding off the market because right now it has equal size of our business,' said Lars Fruergaard Jorgensen, the departing CEO.
Compounders, in particular, have targeted Wegovy because it was the most well-known brand, Kumar said. That has helped Eli Lilly to get an edge.
Eli Lilly catches up, and then some
Novo Nordisk had a huge head start. After Ozempic went on sale, it was another 4½ years before a serious competitor emerged: Eli Lilly's Mounjaro, the brand name for tirzepatide, a drug used to treat diabetes.
Mounjaro proved to be more effective, leading to greater weight loss in clinical trials. Many patients said they preferred it. At the start of this year, Eli Lilly's Zepbound, which is tirzepatide marketed for weight loss, passed Wegovy in new prescriptions in the United States, according to IQVIA, an analytics company.
Unlike Novo Nordisk, Eli Lilly also found ways to get its product to consumers more cheaply, and compete with telehealth companies offering compounded copycat versions, by selling its drug in vials with syringes instead of the more expensive pens with prefilled doses.
Novo Nordisk was further hampered by its slowness in introducing a direct-to-consumer sales platform. NovoCare Pharmacy launched in March, 14 months after LillyDirect.
'Lilly was doing all these things, and Novo wasn't,' said Emily Field, an analyst at Barclays, who recently downgraded the stock.
'It felt like a lot of this was one big own goal,' she said.
Novo's pipeline struggles to impress
More than anything, a company's market value is determined by investors' expectations for earnings in the future. For a pharmaceutical company, that means the drugs in its pipeline. This has helped Eli Lilly's stock outperform Novo Nordisk's this year.
Loading
Investors and analysts are particularly interested in the prospects of weight-loss pills, which could reach more patients than injections. Eli Lilly's daily pill, orforglipron, has been showing promising results in late-stage clinical trials, with similar weight loss to Novo Nordisk's injections and fewer restrictions on its use. Novo Nordisk's oral tablet leads to less weight loss than its injections, but the company has other pills in development.
On Thursday, Eli Lilly said its orforglipron tablets led to 12 per cent weight loss, slightly less than analysts expected, which dented Eli Lilly's shares and gave Novo Nordisk's a boost. But Eli Lilly also raised its overall earnings forecast for the year, on greater demand for Zepbound.
In developing its pipeline, Eli Lilly is 'deploying capital and running faster than Novo in a market that isn't going to be patient in any way,' said Seamus Fernandez, an analyst at Guggenheim Partners.
Can a new leader make a difference?
The Novo Nordisk Foundation, which controls Novo Nordisk through its holding company, has also grown impatient. At the foundation's urging, Jorgensen, who had been CEO of the company since Ozempic came onto the market, stepped down.
Maziar Mike Doustdar took over the top role on Thursday, the first non-Dane to run the company. Doustdar, an Iranian-born Austrian citizen who grew up in the United States, joined the company in 1992, for what he thought would be a summer job making photocopies.
'He has a bias for speed, for pace and for action,' Helge Lund, the chair of the board of directors, said when announcing Doustdar's appointment.
Loading
Concerns are mounting that analysts may have overestimated the potential size of the weight-loss market, or at least how easily more people will gain access to these drugs. At the same time, US President Donald Trump is pressuring companies to lower drug prices and threatening tariffs on medicines produced abroad, casting a cloud over pharma firms' business models.
'I still believe there's a big market,' said Powell of Polar Capital, which invests in Novo Nordisk and Eli Lilly. But broad concerns about the market are hitting Novo Nordisk hardest, he added.