Regeneron's Libtayo reaches blockbuster status and has potential for more growth: execs

Moments after Regeneron CEO Len Schleifer scolded analysts for asking too many questions about the disappointing sales of eye disease drug Eylea HD during a conference call on Tuesday, the next query—much to Schleifer’s dismay—came about the same subject.

“Why don’t we come back to that question at the end so we can get some non-Eylea questions in,” Schleifer said.

In addressing the fourth-quarter figures for Eylea three weeks earlier at the J.P. Morgan Healthcare Conference, Regeneron had hoped to shift the focus of its quarterly call to positive news, such as the performance of its cancer drug Libtayo.

In the fourth quarter of 2024, Libtayo grew sales 50% to $367 million, propelling the PD-1 treatment past the blockbuster threshold for the first time. During the full year, the drug's sales reached $1.22 billion.

“We are encouraged by Libtayo growth as it continues to beat expectations,” analysts from Citi wrote, pointing out that the consensus expectation for the period for Libtayo was $316 million.

After its approval in 2018, Libtayo made solid annual sales gains from $348 million in 2020 to $578 million two years later. In 2022, Regeneron paid its partner Sanofi $900 million for full rights to the checkpoint inhibitor.

Helping Libtayo reach its potential was a 2022 nod to treat newly diagnosed non-small cell lung cancer (NSCLC), allowing it to compete with Merck’s powerhouse PD-1 drug Keytruda.

More growth potential is possible as the company pointed to positive data posted for adjuvant use of Libtayo in patients with cutaneous squamous cell carcinoma (CSCC). With that result, the drug has become "the first immunotherapy to show a benefit in this high-risk population,” Regeneron chief scientific officer George Yancopoulos said during the call.

Adjuvant Libtayo showed a 68% reduction in the risk of disease recurrence or death compared to placebo in the same indication where Keytruda failed. Regeneron hopes for approval in the indication in the second half of this year.

Regeneron also is studying Libtayo as a combo therapy with the company’s fianlimab, going up against Keytruda, in first-line melanoma.

“If these data confirm best-in-class activity in melanoma, it will increase our confidence for this combination in other cancer settings,” Yancopolous added.

The company also made noise on Tuesday with a surprise announcement of an $0.88 quarterly cash dividend—a first for the company—which “should help attract new investors to the name while not detracting from the company’s prevailing capital allocation priorities,” analysts with Evercore ISI wrote.

As for revenue, Regeneron reported it at $3.79 billion for the fourth quarter, which was up 10% year over year. The company's full-year haul came in at $14.2 billion, which was an increase of 8%.