Regeneron Pharmaceuticals posted fourth-quarter adjusted earnings above estimates, aided by strong demand for Dupixent, the eczema treatment it co-develops with Sanofi. The company reported adjusted earnings per share of $11.44, outpacing analysts' projection of $10.62, and total quarterly revenue of $3.88 billion versus an expected $3.80 billion.
Dupixent has become an increasingly significant growth engine for Regeneron as sales of Eylea, its treatment for certain eye diseases, face pressure from lower-cost alternatives and competing drugs such as Roche's Vabysmo. Sanofi, which partners with Regeneron on Dupixent, recorded quarterly Dupixent sales up 34% to $4.9 billion, a figure that matched analysts' expectations.
Eylea sales declined notably during the quarter. Total revenue for Eylea fell 28% to $1.1 billion, missing the LSEG-compiled estimate of $1.25 billion. The company continues to encounter competitive challenges in the ophthalmology segment that have weighed on Eylea's contribution to Regeneron's top line.
Regeneron reported $425 million in sales for its cancer therapy Libtayo, above the $375.68 million analysts had forecast. That product provided an additional boost to results amid mixed performance across the product portfolio.
The company has also been navigating regulatory setbacks linked to a manufacturing issue at the Catalent facility, now operated by Novo Holdings. Those problems led to delays in three pending U.S. Food and Drug Administration applications for Eylea. Regeneron said the FDA has approved a new manufacturer to fill vials for the high-dose formulation of Eylea, and that a regulatory decision on the company’s application is expected in the second quarter of next year.
Investors are watching how Regeneron and Sanofi will manage an eventual decline in Dupixent sales when the drug loses key patents beginning in 2031. Sanofi Chief Financial Officer François-Xavier Roger stated on Thursday that the company would not be able to fully offset the loss of sales once Dupixent, its largest revenue driver, comes off patent.
The quarter’s results highlight a mixture of robust branded-product demand and significant near-term challenges. Dupixent's strong sales performance is offset by Eylea's decline and regulatory interruptions affecting supply and approvals. Management faces the task of sustaining growth while navigating competition, manufacturing remediation, and the long-term patent landscape for their leading product.
Data points from the quarter:
- Adjusted earnings per share: $11.44 (estimate $10.62)
- Total revenue: $3.88 billion (estimate $3.80 billion)
- Sanofi-reported quarterly Dupixent sales: $4.9 billion, up 34%
- Total Eylea sales: $1.1 billion, down 28% (estimate $1.25 billion)
- Libtayo sales: $425 million (estimate $375.68 million)