Regeneron targets September data drop from COVID-19 antibody trial

As the company that developed an antibody against Ebola, Regeneron quickly emerged as one of the most closely watched players in the multi-front campaign to get the SARS-CoV-2 virus under control. Regeneron went on to establish itself toward the front of the race to develop an antibody product capable of treating and preventing COVID-19.

Having done so, Regeneron is now closing in on the publication of data that will start to show what effect its two-antibody cocktail REGN-COV2 has on people infected with the pandemic coronavirus.

Talking to investors on a second quarter results conference call, Regeneron CSO George Yancopoulos said the plan is to share “initial virology and biomarker data from the treatment studies by the end of September with clinical outcome data to follow as enrolment progresses​.”

Regeneron, like other anti-SARS-CoV-2 antibody developers such as Eli Lilly, is also testing its product in the prevention of COVID-19.

The prevention program puts Regeneron up against COVID-19 vaccines that could offer more durable protection and are at a similar stage of development. Despite that, Regeneron thinks there will be space in the immunization market for its antibody cocktail.

“There will be many people who are not vaccinated or whose vaccination effects wore off and they got ill, or even if they were vaccinated, they didn’t get enough of a response. So, we think there are a lot of places for passive immunization with an antibody​,” said Regeneron CEO Leonard Schleifer.

Backed by a contract with the US government, Regeneron is preparing to ship large volumes of its antibody cocktail. When used prophylactically, Regeneron calculates it could manufacture hundreds of thousands of doses per month. The figure falls to tens of thousands of doses per month at the therapeutic dose. Both figures could change once Regeneron sees the clinical trial data.

Regeneron is ramping up spending to get the antibody cocktail to market. In the second quarter, R&D costs rose 36% to $580 million “driven by significant development costs for both our antibody cocktail and Kevzara clinical trials for COVID-19​,” said Regeneron CFO Bob Landry. Kevzara is the IL-6 antibody that Regeneron trialled in an unsuccessful COVID-19 clinical trial.

The step up in spending led Regeneron to raise the midpoint of its forecast R&D costs for the full year by 18%. Regeneron expects more than half of the increase in its R&D guidance to be reimbursed in relation to its work on COVID-19.

Regeneron also expects cost of goods sold (COGS) to increase. As of the second quarter, Regeneron is targeting full-year COGS of $435 million to $485 million, up around 40% on the forecast it provided three months ago.