- Despite double-digit revenue growth, Regeneron Pharmaceuticals wasn't able to quell Wall Street frustrations over products performing below expectations.
- Revenues reached $1.51 billion for the first quarter, an increase of 15% from the year prior — though still 1% below consensus. The big biotech's eye treatment Eylea was a bright spot yet again, with net sales in the U.S. also up 15% to $988 million. As Regeneron's partner Sanofi reported last week, global sales for Dupixent clocked in at $131 million for the quarter, well below what analysts had projected.
- On its pipeline, Regeneron initiated a Phase 2 study of REGN3500 in asthma and a Phase 3 study of evinacumab in homozygous familial hypercholesterolemia during the first quarter, and in April had approval applications for its PD-1 antibody cemiplimab accepted by U.S. and European regulators.
Regeneron shares have lost more than a quarter of their value in the last year, prompting at times tense exchanges between company executives and analysts during an earnings call Thursday. In one instance, Leerink analyst Geoffrey Porges asked why there hasn't been more long-term guidance, buybacks, dividends, price increases or product acquisitions.
"We don't think Geoff, to be frank, it's our job to try and guess things that we don't have anymore information about than you guys have," responded George Yancopoulos, Regeneron's president and chief scientific officer, in reference to guidance. "And we also don't want to spend a lot of our internal team's intellectual horsepower trying to guess what a given number of patients will be. That's kind of why you guys are overpaid, you're supposed to make those guesses."
Regeneron defended its drugs as well.
"We have, what I think of as, one of the most prolific R&D engines in the industry, and we are not nearly as desperate as other companies are to fill up gaps in the pipeline," CEO Leonard Schleifer said.
The company is particularly confident in one asset: cemiplimab, a monoclonal antibody that targets the PD-1 protein like Merck & Co.'s Keytruda (pembrolizumab) and Bristol-Myers Squibb's Opdivo (nivolumab). Regeneron is testing the drug both alone and in combination with either a bispecific antibody or an anti-LAG3 antibody.
Regeneron expects an approval decision from the Food and Drug Administration on cemiplimab in metastatic or locally advanced cutaneous squamous cell carcinoma by October 28. On the call, company executives talked up the technology backing cemiplimab's development and the robust clinical programs investigating it.
"On top of that, as we've already described, we have this very impressive and comforting data in the squamous cell carcinoma indication, which has some of the best data ever described in solid tumor settings for a PD-1 agent. So these combined give us a lot of hope that our first-line cancer studies are going to deliver on the order of Keytruda-like data, which would make us basically a real major competitor in this space," Yancopoulos said.
Regeneron has six drugs in late-stage testing, half of which already have FDA approvals. Of the other three, there's not much riding on fasinumab, a treatment for osteoarthritis and chronic lower back pain co-developed with Teva Pharmaceutical Industries, according to Leerink's Porges.
"We believe investors are attributing no credit to this pipeline asset, and since 50% of the risk has been laid-off to partner Teva ... we do not view potential failure of the trial as a materially negative event for the stock," Porges wrote in a May 3 note, referring to an ongoing trial that scrapped a high dose of fasinumab based on risk-benefit assessments from an independent Data Monitoring Committee.
A win with cemplimab, therefore, may be needed to restore some investor confidence.