Ipsen’s Iqirvo is off to a solid start with sales (PDF) of 23 million euros ($26 million) in the first quarter of this year as it battles for market share with two other drugs—one old and one new—to treat patients with the rare liver disease primary biliary cholangitis (PBC).
Ipsen and its fellow French partner Genfit are competing with Intercept and Advanz’s Ocaliva, which was approved in 2016 and had the market to itself until last year, when Iqirvo and Gilead’s Livdelzi notched FDA approvals two months apart in the indication.
Iqviro and Livdelzi appear primed to make gains as Ocaliva lost its marketing authorization in Europe five months ago, just weeks after the FDA denied Intercept’s bid to convert Ocaliva’s accelerated approval into a full nod. The fortunes of the farnesoid X receptor (FXR) agonist dimmed after a re-assessment of its risk-benefit profile in Europe. In the U.S., the drug still carries an accelerated approval.
“The launch continues to track well in line with our expectations,” Ipsen CEO David Loew said of Iqirvo during a Wednesday conference call.
Loew touted the success of recent launches in Germany and the U.K., adding that Ipsen is set to launch the drug in other countries this year.
“We have been assuming about a third of market share, which is what we are seeing currently,” Loew added. “We see about 60 percent of the patients coming de novo second line and the rest from Ocaliva switches."
Though PBC is a rare disease, the market is significant. In 2022, which is the last year Intercept reported sales before selling out in 2023 to Italian private company Alfasigma, Ocaliva generated revenue of $343 million.
Upon the approval of Iqirvo, analysts estimated (PDF) its sales would reach 193 million euros ($220 million) in 2027, while peak sales have been tabbed at 400 million euros ($456 million).
By comparison, Gilead’s Livdelzi generated sales of $30 million in the fourth quarter of last year. The company will report its first quarter sales next week.
Iqirvo isn’t Ipsen’s only rare liver disease drug. The company also reported sales of Bylvay at 43 million euros ($49 million) in the first quarter, which were up 63% year over year. Ipsen acquired the once-daily ileal bile acid transport inhibitor (IBATi) when it bought out Albireo Pharma two years ago. Bylvay was approved for progressive familial intrahepatic cholestasis (PFIC) in 2021 and for Alagille syndrome (ALGS) in 2023.
In a note to clients this week, analysts with ODDO BHF said Bylvay and Iqirvo are "chalking up good ramp-up scores."
As for Ipsen's overall performance in the first quarter, the company reported sales of 919 million euros ($1.05 billion), an increase of 12% year over year. The company reiterated its projection of at least 5% growth this year.
Despite the sales bump, Ipsen’s share price declined by 5% on Wednesday, which could be attributed in part to oncoming generic competition for the company’s top-selling product, cancer drug Somatuline.
Also at play is “disappointing patient uptake” of rare bone disease drug Sohonos, according to Craft & Capital analyst Wan Nurhayati, who also pointed out that Ipsen took an impairment charge of 281 million euros ($319 million) on Sohonos in 2024 and that the product's first quarter sales were down 47% year over year.