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Regeneron (REGN) Gains 9.3% in a Year: Will the Uptrend Last?
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Shares of Regeneron Pharmaceuticals, Inc. (REGN - Free Report) have gained 9.3% in the past year against the industry’s decline of 15.2%.
Last month, the company reported better-than-expected fourth-quarter 2022 results even though lead drug Eylea (aflibercept) sales declined as Dupixent maintained its stellar performance, with progress on launches in pediatric atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
Eylea sales were negatively impacted by a short-term shift to off-label use of Avastin (bevacizumab), a temporary closing in the fourth quarter of 2022 of a not-for-profit fund that provides patient co-pay assistance and an increase in sales-related deductions.
Image Source: Zacks Investment Research
Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . Regeneron records net product sales of Eylea in the United States and Bayer records net product sales of Eylea outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.
While management believes that it has substantially recovered from the issue encountered in the fourth quarter, it continues to expect competitive pressures for Eylea.
The Eylea injection was recently approved to treat preterm infants with retinopathy of prematurity.
Regeneron is now focused on the potential launch of aflibercept 8mg following a tentative approval. In February 2023, FDA accepted for Priority Review the biologics license application for aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. FDA’s target action date is Jun 27, 2023, following the use of a priority review voucher. The company expects a potential U.S. launch in late August 2023.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Regeneron’s top line is also boosted by its share of profits/losses in connection with global sales of Dupixent. Partner Sanofi (SNY - Free Report) records global net product sales of Dupixent. Dupixent maintains its dominant position in atopic dermatitis, asthma and nasal polyps, and has been approved in new indications, geographies and younger populations. Dupixent was recently approved by the European Commission to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
Meanwhile, Regeneron is looking to diversify in the lucrative oncology space with Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer (NSCLC). The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo in combination with platinum-based chemotherapy for first-line treatment of adult patients with advanced NSCLC with ≥1% PD-L1 expression.
Hence, Regeneron should maintain its solid performance in 2023 as well.
However, stiff competition from the potential entry of generics and new treatment options weighs on Eylea. While Libtayo holds promise, the competition is stiff in this oncology space with many formidable drugs.
Image: Bigstock
Regeneron (REGN) Gains 9.3% in a Year: Will the Uptrend Last?
Shares of Regeneron Pharmaceuticals, Inc. (REGN - Free Report) have gained 9.3% in the past year against the industry’s decline of 15.2%.
Last month, the company reported better-than-expected fourth-quarter 2022 results even though lead drug Eylea (aflibercept) sales declined as Dupixent maintained its stellar performance, with progress on launches in pediatric atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
Eylea sales were negatively impacted by a short-term shift to off-label use of Avastin (bevacizumab), a temporary closing in the fourth quarter of 2022 of a not-for-profit fund that provides patient co-pay assistance and an increase in sales-related deductions.
Image Source: Zacks Investment Research
Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . Regeneron records net product sales of Eylea in the United States and Bayer records net product sales of Eylea outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.
While management believes that it has substantially recovered from the issue encountered in the fourth quarter, it continues to expect competitive pressures for Eylea.
The Eylea injection was recently approved to treat preterm infants with retinopathy of prematurity.
Regeneron is now focused on the potential launch of aflibercept 8mg following a tentative approval. In February 2023, FDA accepted for Priority Review the biologics license application for aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. FDA’s target action date is Jun 27, 2023, following the use of a priority review voucher. The company expects a potential U.S. launch in late August 2023.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote
Regeneron’s top line is also boosted by its share of profits/losses in connection with global sales of Dupixent. Partner Sanofi (SNY - Free Report) records global net product sales of Dupixent. Dupixent maintains its dominant position in atopic dermatitis, asthma and nasal polyps, and has been approved in new indications, geographies and younger populations. Dupixent was recently approved by the European Commission to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
Meanwhile, Regeneron is looking to diversify in the lucrative oncology space with Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer (NSCLC). The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo in combination with platinum-based chemotherapy for first-line treatment of adult patients with advanced NSCLC with ≥1% PD-L1 expression.
Hence, Regeneron should maintain its solid performance in 2023 as well.
However, stiff competition from the potential entry of generics and new treatment options weighs on Eylea. While Libtayo holds promise, the competition is stiff in this oncology space with many formidable drugs.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.