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Looming competition for Novartis’ radioligand portfolio will have “minimal effect” on market performance in the coming years, CEO Vas Narasimhan contended, as the Swiss pharma faces pressures from incoming generic versions of Lutathera.
Narasimhan was responding to a question about the recent tentative approval for a generic competitor to Novartis’ radiopharma therapy Lutathera, indicated for gastroenteropancreatic neuroendocrine tumors (GEP-NET), during a Tuesday morning call with reporters as the pharma’s presented first-quarter earnings results.
The FDA last month cleared Lantheus’ product as the first radioequivalent therapy for Lutathera for the same indication. Narasimhan emphasized confidence in the pharma’s “strong market position” for Lutathera, with hundreds of activated treatment centers and years of reliable and timely drug deliveries.
The pharma’s certainty in the resilience of its business against competitive threats extends beyond Lutathera and radiopharma, and comes even as generics have pulled down the company’s quarterly performance. In the first quarter, Novartis’ net sales slid 5% year-on-year to $13.11 billion, versus $13.23 billion in the same period last year. The pharma attributed this dip to generic erosion in the U.S.
Net income dropped 13% year-on-year and earnings-per-share, which came out to $1.65, was 11% lower than in Q1 last year.
Much of the market erosion was for the company’s blockbuster heart failure drug Entresto, sales of which plummeted 46% from Q1 2025 to $1.3 billion. Cosentyx, indicated for various immune disorders, saw a 2% dip in sales to $1.57 billion, though this was driven not by competitive erosion but by revenue adjustments, according to the company.
Together, Cosentyx and Entresto were more than enough to offset the sales growth across most of Novartis’ pipeline, but chief financial officer Mukul Mehta told reporters Tuesday that this negative trend won’t last.
“We do expect growth to return to our [profit-and-loss] second half of this year,” Mehta said, at which point growth from the rest of the commercial portfolio will start to overtake generic erosion.
Despite the topline drag, product sales showed positive trends across the board. One of Novartis’ top-performing drugs was the breast cancer drug Kisqali, which surged 55% year-on-year to bring in $1.52 billion. Also helping drive growth for the pharma is multiple sclerosis injection Kesimpta, which made $1.16 billion in Q1, a 26% increase. The radiopharma therapy Pluvicto, approved for prostate cancer, grew 70% to hit $642 million in sales.
As for the future of Lutathera, Narasimhan emphasized Novartis’ strong patent protection. Lantheus’ radioequivalent received only tentative approval, meaning that while the regulator has deemed the application worthy of approval, Lantheus will have to wait for a 30-month stay to expire before the product can be marketed, according to a news release from the biotech last month. The stay, triggered by patent litigation brought by Novartis in January 2024, will expire in June.
Narasimhan on Tuesday said that the Lantheus approval is an “important precedent” for the radiopharma space that has allowed Novartis to “show how [radioligand therapy] patents should be upheld in the courts.”
“We believe our patents are fully valid and we’ll continue to defend them,” Narasimhan said.
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Novartis’ sales dip as generics pressure intensifies, radioequivalents loom – BioSpace
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