Regeneron culls two drugs from pipeline amid double-digit revenue drop after Covid mAb cocktail pull

03 Nov 2022
endpts.com
CollaborateAntibodyBiosimilar
It’s not always a good sign when a company reports a substantial market drop, but part of the drop is just moving forward.
Regeneron, headed by billionaires CEO Leonard Schleifer and CSO George Yancopoulos, reported Q3 earnings Thursday morning — quietly noting a 15% drop in revenue compared to Q3 last year, pulling in $2.94 billion.
Schleifer sought to blunt the drop in the company’s overall numbers, telling investors and analysts on the earnings call that “total revenues for the quarter increased by 11% compared to last year, when excluding contributions from our COVID antibody cocktail.”
The cocktail was pulled from use in the US last January after it was found to not work against the strain of Omicron at the time.
The company also quietly revealed on Thursday that it’s cutting two drugs from its pipeline: a multi-antibody therapy, known as REGN1908-1909, to treat allergies in cats — and the Teva and Mitsubishi Tanabe-partnered NGF antibody fasinumab.
Fasinumab is a pain drug, which was being investigated by Regeneron in patients with osteoarthritis pain of the knee or hip. A Phase III trial involving the drug had noted some high enrollment numbers, over 3,000 at one point.
Why non-opioid pain drugs keep failing — and what's next for the field
The news comes more than six years after Teva inked a $2.6 billion deal — including $250 million upfront — to buy in on Regeneron’s pain drug. Back in 2020 the pharma reported Phase III data from FACT OA1 and FACT OA2, which compared fasinumab to placebo over 16 weeks and 24 weeks and looked at co-primary endpoints measuring pain and physical function in patients with osteoarthritis.
While the monthly dose showed statistically-significant improvements in both trials, safety remained a major concern as analysis looked at a possible increase in joint issues, aka arthropathies, in those who took the drug.
Regeneron did not elaborate why fasinumab was cut on its earnings call.
Regeneron adds more positive PhIII data for its NGF program — but safety is still a big concern
Regeneron execs spent a substantial amount of time talking about the Bayer-partned Eylea, which may stave off biosimilars until 2024, and is now the company’s biggest sales driver outside the Sanofi-partnered Dupixent.
“Eylea global net sales grew 8% at constant currency to $2.4 billion. In the US, Eylea net sales were $1.63 billion  — up 11% year over year, and outperforming the anti-VEGF category growth of only 4%. Despite recent branded and biosimilar entrants, Eylea set a new all time high for anti VEGF category share in the United States,” Schleifer said Thursday morning.
Regeneron and Bayer’s partnered blockbuster grabbed sixth months of pediatric exclusivity from the FDA, extending its runway into 2024.
Regeneron, Bayer's Eylea nabs six months of pediatric exclusivity as competition waits to enter the market
When it comes to Sanofi, the two are still partnered on Dupixent, the IL-4 and IL-13 dual inhibitor that Sanofi has centered itself around in recent months. Regeneron also inked a substantial deal with Sanofi back in June to acquire full rights to Libtayo, the PD-1 treatment that the two had previously split profits on, earning the company $306 million last year.
Regeneron agreed to front $900 million for the full rights, sweetening the pot with an 11% royalty on worldwide sales and adding another $200 million in milestones.
“We believe Libtayo is poised to become a more meaningful revenue contributor over time,” Regeneron’s chief executive added.
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