Can Regeneron Pharmaceuticals (REGN 2.22%) stop the slide?
That's the question that was on investors' minds as the biotech prepared to announce its third-quarter results before the market opened on Friday. Regeneron's shares are down around 40% year to date. Was there something in the latest quarterly results that might ignite a rebound? Here are three things you need to know from Regeneron's third-quarter update.
1. Eylea sales growth slowing
Regeneron reported revenue in the third quarter of $1.22 billion, up 7% year over year. Sales for Eylea made up 70% of total revenue. The good news is that the eye-disease drug saw sales climb 16% compared to the prior-year period, to $854 million. The bad news is that sales growth appears to be slowing.
In the second quarter, sales for Eylea were up nearly 27% from the same quarter in 2015. That was slower than the drug's first-quarter year-over-year sales growth of 44%.
Regeneron narrowed its full-year 2016 guidance for Eylea sales. The company now expects 23% to 25% growth over 2015. Previously, Regeneron projected 20% to 25% growth. This upward revision to the low end of the range isn't very encouraging, though.
2. Praluent sales picking up
While Eylea's sales are slowing, Praluent is gaining some momentum. Sanofi (SNY 1.70%) records product sales for the drug with Regeneron sharing in the profits (or losses). Regeneron's portion of the sales for the cholesterol drug totaled $38 million in the third quarter. That's more than the biotech made from Praluent in the first and second quarters of 2016 combined.
There are a couple of things that should help Praluent pick up more. The less important of the two is potentially gaining regulatory approval for a monthly dosing regimen of the drug. Regeneron and Sanofi expect a decision by the U.S. Food and Drug Administration (FDA) by Jan. 24, 2017. The companies also submitted for approval of a monthly dosing regimen in Europe.
The more important potential catalyst for Praluent will be results from an ongoing cardiovascular outcomes study. Regeneron and Sanofi expect a second interim analysis of this study will be finished by the end of November. First results of the study won't be released until late 2017, with final results likely to be announced no sooner than the first quarter of 2018.
3. Strong earnings growth
Investors might have been disappointed by slowing sales of Eylea, but they had to like Regeneron's bottom line. The biotech managed to beat earnings estimates handily.
The consensus among Wall Street analysts was that Regeneron would report third-quarter earnings of $2.71 per share. Regeneron's actual third-quarter non-GAAP (adjusted) earnings came in at $3.13 per share. That not only beat analysts' expectations but also represented a solid 32% increase from the prior-year period.
Regeneron reported GAAP earnings of $264.8 million, or $2.27 per diluted share. That was also an improvement from the $210.4 million, or $1.82 per diluted share, posted in the prior-year period.
With Eylea's growth slowing, Regeneron needs a boost from Praluent and its pipeline. I expect that Praluent's sales will help tremendously -- but not as much as needed until the cardiovascular outcomes study results are available.
As for the pipeline, Regeneron and Sanofi received some bad news recently when the FDA sent a complete response letter (CRL) for experimental rheumatoid arthritis drug sarilumab. That was certainly a setback, but the CRL related to manufacturing deficiencies rather than the drug's safety or efficacy. I don't think this will derail the two companies for long.
Regeneron's pipeline includes several strong candidates in addition to sarilumab. An FDA decision is expected by March 29, 2017, for Dupixent in treating moderate-to-severe atopic dermatitis. The drug is also in a late-stage study targeting treatment of asthma. Experimental pain drug fasinumab, respiratory syncytial virus antibody REGN2222, and potential diabetic retinopathy treatment aflibercept are also in late-stage studies.
I don't think Regeneron will enjoy the heady growth it has experienced over the last five years as Eylea took off. However, Praluent and a strong pipeline should enable the biotech to keep on growing in the future. I believe Regeneron can -- and will -- stop the current slide. Eventually.