Regeneron (REGN) currently has six FDA-approved drugs and 17 investigational therapies in its research pipeline. Of these, Eylea continues to be the major revenue driver for Regeneron in 2018.
Revenue estimates for 2018
Wall Street analysts expect Regeneron to report revenue of close to $6.3 billion in 2018, a YoY (year-over-year) rise of ~7.6%.
Eylea’s growth trajectory
Eylea accounted for ~70% of the branded anti-vascular endothelial growth factor (or anti-VEGF) therapy market for retinal diseases in the United States and continued to lead in the segment at the end of the first quarter. Regeneron witnessed a slight increase in Eylea’s dollar share of the branded anti-VEGF therapy market for retinal diseases in the United States in the quarter.
Eylea reported sales of close to $984 million in the US market in the first quarter, of which 70% was attributable to wet age-related macular degeneration (or wet AMD) indications, 25% was attributable to diabetic macular edema indications, and the remaining 5% was attributable to other, smaller indications.
Although the wet AMD market is well penetrated, increasing life expectancy leading to the rising prevalence of AMD has helped boost demand for Eylea. Regeneron’s strategy for its Eylea franchise involves expanding the label of the drug across indications, dosage regimens, and modes of administration.
The FDA has accepted the company’s supplemental biologics license application (or sBLA) seeking approval for a 12-week dosing regimen for Eylea in a wet AMD indication. The Prescription Drug User Fee Act date for this sBLA is August 11, 2018. If approved, this label expansion will enable physicians to choose between a four-week, eight-week, and 12-week dosing schedule based on patient requirements.
In the second half of 2018, Regeneron also plans to submit an sBLA to the FDA seeking approval for Eylea in prefilled syringe form in wet AMD indications.
In the next article, we’ll discuss Regeneron’s margin growth prospects for 2018.