Regeneron Wins FDA Nod For Evkeeza Antibody Therapy; Street Sees 34% Upside

Regeneron announced that the US Food and Drug Administration (FDA) has approved its Evkeeza antibody as a first-of-its-kind treatment for adult and pediatric patients with extremely high low-density lipoprotein cholesterol (LDL-C).

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Regeneron (REGN) said that the approval followed clinical trials, which showed that Evkeeza significantly lowered LDL-C levels and offers a new therapy for people living with homozygous familial hypercholesterolemia (HoFH).

Evkeeza, a fully-human monoclonal antibody, connects to and blocks the function of angiopoietin-like 3 (ANGPTL3), a protein that plays a significant role in lipid metabolism.

About 1,300 patients in the US are being affected by HoFH, also known as homozygous FH. It is an ultra-rare hereditary, which occurs when two copies of the familial hypercholesterolemia (FH)-causing genes are inherited, one from each parent. It causes severely high levels (>400 mg/dL) of LDL-C (bad cholesterol). HoFH patients are at risk for premature atherosclerotic disease and cardiac arrests as early as 12 years and older. (See Regeneron stock analysis on TipRanks)

Regeneron President George D. Yancopoulos said, “We are proud to bring Evkeeza to patients with HoFH, and Regeneron is grateful to the patients and doctors who participated in our trials to make this a reality.”

Earlier this week, Regeneron and Sanofi announced the FDA approval of Libtayo used in the treatment of patients with advanced stages of the two most common skin cancers in the US.

Last week, Regeneron reported 4Q and FY20 results. The company’s 4Q adjusted earnings increased 27% to $9.53 per share on a year-over-year basis, beating the Street’s estimates of $8.43 per share. Total sales grew 30% to $2.42 billion and came in line with analysts’ expectations.

As for 2021, the company expects adjusted research & development (R&D) expenses in the range of $2.70-$2.85 billion. Adjusted selling, general, and administrative (SG&A) costs are forecasted to be between $1.5 billion and $1.63 billion.

On Feb. 8, Oppenheimer analyst Hartaj Singh reiterated a Buy rating on the stock with a price target of $725 (47.8% upside potential). Singh argues that the company has “the best-in-class pipeline, a superior sales/earnings progression and manageable future competition against Eylea/Dupixent.”

The rest of the Street is cautiously optimistic about the stock with a Moderate Buy consensus rating. That’s based on 10 analysts suggesting a Buy and 5 analysts recommending a Hold. The average analyst price target of $658 implies more than 34% upside potential to current levels. Shares have increased 27% in the past year.