The company’s $3 billion in earnings for the first quarter missed on both top and bottom line, according to BMO Capital Markets. Adding insult to injury, the FDA declined to approve a prefilled syringe of its ophthalmology cornerstone.
Regeneron’s shares tumbled 7% pre-market Tuesday morning on a first quarter earnings miss plus an FDA rejection of a prefilled syringe version of blockbuster eye med Eylea.
According to BMO Capital Markets, Regeneron’s earnings missed on top and bottom line. The company reported first quarter earnings of $3 billion. BMO now expects a “messy quarter” as Regeneron tries to make up for losses in its key Eylea franchise.
The retinal disease therapy took in $1.05 billion in total U.S. sales for the quarter, a 26% decrease on the same period a year ago. Both standard Eylea and Eylea HD decreased.
“While we anticipated this may be a more messy quarter for Eylea due to ongoing funding concerns for patient assistance charities, other factors further exacerbated this dynamic,” BMO wrote Tuesday morning.
Those other factors include pressure from Genentech’s Avastin, a lower net selling price, lower wholesale inventory and continued biosimilar pressure. Plus, Regeneron revealed that it received a complete response letter from the FDA rejecting a pre-filled syringe version of Eylea, which BMO said has created “another near-term challenge.”
Regeneron had been banking on the approval in the middle of this year. The FDA’s letter apparently took issue with a third-party component supplier of the syringe, according to BMO. The delay for this version of the medication could dent sales for the overall franchise, the firm noted. Competitors such as Roche’s Vabysmo have benefitted from having a pre-filled syringe on the market, BMO said.
Regeneron’s shares fell to $568 in pre-market trading on Tuesday, compared to $610.86 at close Monday.
