Successful launch bolsters Libtayo's place as cornerstone therapy for Regeneron
- Regeneron Pharmaceuticals' Libtayo fetched net sales of $15 million during its first three months on the market, according to the biotech's fourth quarter earnings presented Wednesday.
- The immuno-oncology drug first gained U.S. approval at the end of September for advanced cutaneous squamous cell carcinoma (CSCC). Though five checkpoint inhibitors targeting the PD-1/L1 pathway were approved before Libtayo, Regeneron has remained remained confident of the drug's competitiveness given the lack of therapies for advanced CSCC patients and the fact that it targets PD-1 rather than PD-L1, which some say provides a more effective form of treatment.
- Investment bank Piper Jaffray noted that Libtayo's fourth quarter performance "handily" beat consensus of $8 million in net sales.
Libtayo (cemiplimab) is off to a speedy launch in spite of an ever-crowding immuno-oncology market.
On Wednesday's earnings call, management touted how 95% of total lives had reimbursement coverage for Libtayo through commercial or government insurance plans. "This is not a product with a lot of inventory building, and what we are seeing is that each month we're showing progress in terms of demand for Libtayo," said Marion McCourt, the biotech's head of commercial.
Yet Libtayo is more than just an immediate revenue boost; it's meant to be a cornerstone for Regeneron's further oncology ambitions. The company is testing the drug in combination with several other anti-cancer agents, including a CTLA4 antibody and a CD20 x CD3 antibody, for diseases such as lymphoma and non-small cell lung cancer.
"Having multiple approaches such as an approved PD-1, the CD20, the CD3, ... under one umbrella, one program, I think is a very powerful and efficient way to be able to move forward," a company executive said on the call.
Regeneron's not alone either. Combo treatments have gained popularity across the cancer drugmaking landscape as companies search for more effective therapies that can be used earlier in the treatment paradigm.
Executives at Merck & Co., maker of the blockbuster immunotherapy Keytruda (pembrolizumab), noted on the company's recent fourth quarter earnings call that spending on Keytruda monotherapy R&D is reaching a crest. Going forward, they expect combo studies to drive R&D expenses.
Most of the Libtayo studies are in the early-stages, with primary completion dates at least a year off. In the meantime, the monotherapy looks like it has already exceeded early Wall Street expectations — though analysts cautioned investors from getting overzealous.
"While one quarter does not make a trend, and we have no color as to inventory effects, etc., [t]his number may raise some eyebrows, especially given the smallish initial indication (cutaneous squamous cell carcinoma) and the fact that Libtayo is the sixth marketed PD-(L)1 antibody," Piper Jaffray's Christopher Raymond wrote in a Feb. 6 note.
Regeneron shares were up almost 2% to $428.90 per share at market's open Wednesday, nearing its 52-week high of $431.32 per share. That value dipped as the day went on, however, falling to about $412 per share by late-morning.
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