Regeneron's top-selling Eylea fueled a double-digit sales leap, but thanks to a looming threat from Novartis and its brand-new Beovu, the Big Biotech still found itself playing defense Tuesday.
In the third quarter, Regeneron booked U.S. Eylea sales of $1.19 billion, 16% above the previous year and 3% ahead of analysts’ consensus. But as Evercore ISI analyst Josh Schimmer noted in a recent note to clients, the drug’s third-quarter performance “won’t matter so much given the dynamic situation,” namely, Novartis’ recently launched Beovu in wet age-related macular degeneration (AMD).
To hear execs tell it, though, Regeneron is well prepared for the Beovu assault.
“We take all the important competitions seriously and certainly have been prepared for new market entrants,” Regeneron’s head of commercial, Marion McCourt, said on a Tuesday conference call. “But it is really early, and we are … not seeing any impact at this time.”
Regeneron indeed has several countermeasures up its sleeves. First, it recently got an additional FDA approval in diabetic retinopathy, whose launch McCourt said is “off to an encouraging start with Eylea use increasing in both proliferative disease and severe non-proliferative disease.”
Meanwhile, it’s looking to relieve physicians of the multiple preparation steps of Eylea by rolling out a single-dose prefilled injector. McCourt said the launch will happen before the end of the year. Besides, it’s starting trials to test higher-dose Eylea to increase its durability.
For now, wet AMD accounts for just under 60% of Eylea’s business, and it continues to grow in this patient group, McCourt said.
Novartis is coming after that market aggressively with Beovu. The Swiss drugmaker has priced the rival at the same wholesale acquisition cost of $1,850 per vial and has started a head-to-head study against Eylea to evaluate their durations of treatment interval with no disease activity.
“I think this is a study which shows our confidence in the overall profile of the medicine,” Novartis CEO Vas Narasimhan said on a call a few days ago.
Physicians “really make their decisions on the ability of a medicine to dry better on the dosing interval, on the safety and on the cost,” and Beovu checks all those boxes, Novartis’ newly minted pharmaceutical chief Marie-France Tschudin said on the company’s call.
When the Novartis drug nabbed its FDA go-ahead in October, industry watchers noted that its label doesn’t include clinical data that showed Beovu outperforming Eylea on secondary measures. Beovu’s approval is for between eight-week and 12-week dosing regimens, while Eylea has four-, eight- and 12-week dosing schedules. Nevertheless, with the Street’s 2021 consensus standing at $4.38 billion, Beovu is a force to be reckoned with.
Other than Eylea, Regeneron’s Sanofi-partnered PD-1 drug Libtayo racked up $48 million in Q3 U.S. sales, largely in line with analysts’ projection. In an update to a phase 3 trial testing Libtayo in newly diagnosed advanced non-small cell lung cancer patients with high PD-L1 expression, Regeneron said among the first 361 randomized patients, Libtayo as a monotherapy achieved an objective response rate of 42%, versus 22% for patients on chemotherapy.
J.P.Morgan analyst Cory Kasimov noted the Libtayo number is so far comparable to the 39% Merck & Co.’s market leader Keytruda has on its label for the same patient group.
All told, Regeneron’s Q3 revenues jumped 23% year over year to $2.05 billion, driven partly also by an increase in Sanofi antibody collaboration haul thanks to higher Dupixent profits.