Regeneron's Dupixent and Eylea Offset Drop in COVID-19 Antibody Sales

 Regeneron Pharmaceuticals reported a 44% drop in revenue for the second quarter compared to the same period in 2021.

This overall drop was associated with sales of REGEN-COV, its antibody cocktail against COVID-19, banned in the U.S. in January, with a few exceptions, because it was ineffective against the Omicron variants. Otherwise, company sales were up 20%.

The real positive drivers were Eylea for chronic eye diseases and Dupixent for inflammatory conditions. Eylea climbed 14% to $1.62 billion. Since 2021, it has brought in $5.79 billion, an increase of 17% from the previous year.

In a note to investors, Wells Fargo analyst Mohit Bansal wrote, “We see 2Q22 results as representing a strong beat, with Eylea results showing a strong front against competition from [Roche’s] Vabysmo and continued momentum from Dupixent."

Dupixent sales jumped almost 40% to $2.09 billion for the second quarter.

“The second quarter of 2022 was distinguished by record net product sales of Eylea, Dupixent, and Libtayo, as well as multiple regulatory achievements for Dupixent, including U.S. approvals for atopic dermatitis among very young patients and for eosinophilic esophagitis in adults and adolescents, as well as European approval for pediatric asthma,” Dr. Leonard S. Schleifer, M.D., Ph.D., president and CEO of Regeneron, said. “In addition, we have continued to strengthen our oncology franchise, including through the purchase of worldwide rights to Libtayo as well as encouraging but preliminary anti-tumor activity observed at higher doses of our novel PSMAxCD28 costimulatory bispecific in combination with Libtayo for advanced metastatic castration-resistant prostate cancer.”

As is common with quarterly reports, Regeneron updated its pipeline, including terminating four clinical trials of REGEN-COV. The axed trials include a study of the antibody cocktail in high-risk patients 12 years and younger, a prevention trial in immunocompromised teens and adults, and a study in children hospitalized with COVID-19 and one for non-hospitalized patients. According to clinicaltrials.gov, the studies were terminated because of “emerging SARS-CoV-2 variants impacting susceptibility to study drug.”

Regeneron’s antibody therapy against COVID-19 wasn’t the only such treatment to lose the battle against variants and antiviral drugs. GlaxoSmithKline-Vir Biotechnology’s sotrovimab, as well as Eli Lilly’s bamlanivamab and etesevimab have shown less effectiveness against variants, resulting in modifications to their Emergency Use Authorizations and sales. Largely, they have been replaced by effective vaccines, such as Pfizer’s Paxlovid and Merck’s Lagevrio.

Regeneron has about 35 drugs in clinical development. 

The company’s collaboration revenue with Sanofi increased by 55% to $678 million for the quarter compared to the same period in 2021. Although they have pulled back on this somewhat in recent years, Regeneron has long been dubbed Sanofi’s “innovation engine.” The increase in revenue was related to shared profits from the commercialization of antibodies and higher Dupixent profits.

Regeneron’s R&D investments were $794 million for the quarter, and Selling, General, and Administrative (SG&A) were $475 million. The GAAP effective tax rate for the quarter was 11.5%, compared to 17.4% in the second quarter of 2021. This was primarily due to the proportion of income earned in foreign sales with lower tax rates than in the U.S.

GAAP net income per diluted share was $7.47 in the quarter, compared to $27.97 in the second quarter of 2021.

“We are pleased with our second quarter 2022 financial performance, including 20% revenue growth when excluding contributions from REGEN-COV. This demonstrates the continued strength of our core business,” Robert E. Landry, executive vice president, Finance, and CFO of Regeneron, said. “Additionally, we updated our full-year 2022 financial guidance primarily to reflect the recently completed acquisition of Libtayo global rights from Sanofi, a transaction that we believe will deliver significant shareholder value over time. In the second half of 2022, we look forward to advancing our pipeline with important clinical data readouts in oncology and ophthalmology as well as continued commercial execution and prudent capital allocation to drive value creation for shareholders.”

https://www.biospace.com/article/regeneron-q2-dupixent-and-eylea-set-off-drop-in-covid-19-antibody-sales/