- Regeneron reported a strong first quarter, with revenues of $1.2 billion versus $870 million in Q1 2015. Net income more than doubled to $165.7 million. Most of the revenues came from Eylea (aflibercept), which had net earnings of $146 million based on $784 million in sales—a 44% increase compared with Q1 2015.
- But Praluent (alirocumb), which Regeneron co-markets with Sanofi, generated $13 million in Q1 2016, lower than analysts' expectations.
- Uptake of Praluent has been slower than originally anticipated, mainly because of payers' demands for prior authorization, as well as an extended period of review ahead of formulary placement.
Uptake of Praluent, which costs roughly $14,600 per year, has been slow, but it's increasing. According to the company, 74% of commercially insured people and 91% of Medicare-insured people had access to Praluent as of April 1.
However, the drug's future may not be bright for Regneron and Sanofi. Amgen, which markets a competition PCSK9 drug, Repatha, has accused the companies of infringing on several of their patents. In March, a US. District Court judge ruled in favor of Amgen after a jury upheld the validity of two Amgen patents on antibodies targeting the PCSK9 enzyme, which binds to LDL cholesterol receptors. Regeneron plans to appeal the decision.
Eylea, for treatment of age-related macular degeneration (AMD) and other eye disorders, continues to be Regeneron's top earner. However, sales momentum has slowed. Last year, sales were up 54%, with projected increases this year in the 20% to 25% range.
With 13 products in clinical development, Regeneron is actively focused on developing its target markets. Two of its drugs, sarilumab (an IL-6 antibody intended to treat rheumatoid arthritis) and dupilumab (for treatment of immune-mediated conditions) are in late-stage development.
In a phase 3 trial, sarilumab demonstrated greater efficacy than AbbVie's market-leading Humira, a multibillion-dollar drug and one of the top-selling drugs in the world.
If legal battles limit Praluent, Regeneron may have to count on that pipeline more than it would like for future growth.