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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) delivered better-than-expected third-quarter 2023 results, even though lead drug Eylea’s (aflibercept) sales declined. Dupixent maintained its stellar performance, driven by continued strong demand in the approved indications, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.
Regeneron’s shares have gained 9.7% in the year so far against the industry’s decline of 23.5%.
Image Source: Zacks Investment Research
The company reported third-quarter earnings of $11.59 per share, comfortably beating the Zacks Consensus Estimate of $10.8. The year-ago quarter recorded earnings per share of $11.14.
Total revenues in the reported quarter were up 15% year over year to $3.36 billion, beating the Zacks Consensus Estimate of $3.23 billion.
Quarterly Highlights
Lead drug Eylea’s sales in the United States were $1.45 billion, down 11% year over year, primarily due to increased competition. Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . Eylea’s sales also missed the Zacks Consensus Estimate of $1.54 billion.
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.
In August 2023, the FDA approved Eylea HD (higher dose of Eylea) for the treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy and Regeneron commenced recording sales in the United States in the third quarter of 2023.
Total revenues include collaboration revenues of $1.4 billion from Sanofi (SNY - Free Report) and Bayer, up from $1 billion in the year-ago quarter. Sanofi’s collaboration revenues increased by 50% to $1 billion, driven by profits associated with higher Dupixent sales. We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with global sales of both drugs. Dupixent’s sales surged 33% year over year to $3.1 billion.
Bayer’s collaboration revenues came in at $377 million, up 13% from the year-ago quarter.
Regeneron records net product sales of Praluent in the United States and Sanofi records net product sales of Praluent outside the United States and pays REGN a royalty on such sales. Prior to Jul 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi recorded net product sales of Libtayo outside the United States. Effective Jul 1, 2022, Regeneron records global net product sales of Libtayo outside the United States and pays a royalty to Sanofi on such sales.
Total Libtayo sales came in at $232 million. Praluent’s net sales in the United States came in at $40.3 million in the reported quarter, up 33% year over year. Kevzara recorded sales of $95.7 million, up 9% from the year-ago quarter.
REGEN-COV, its antibody cocktail for COVID-19, did not generate any sales in the quarter. Regeneron records net product sales of REGEN-COV in connection with its agreements with the U.S. government, and its partner Roche (RHHBY - Free Report) records net product sales of the antibody cocktail outside the United States. The companies share gross profits from global sales based on a pre-specified formula.
Adjusted R&D expenses jumped 16.9% to $954.4 million, while SG&A expenses increased 14.2% to $533.7 million in the year-ago quarter.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
The FDA accepted for priority review the supplemental biologics license application (“sBLA”) for Dupixent, seeking approval of the drug for the treatment of children aged 1 to 11 years with eosinophilic esophagitis. The regulatory body set a target action date of Jan 31, 2024.
In October 2023, the FDA issued a Complete Response Letter (“CRL”) for the sBLA for Dupixent in chronic spontaneous urticaria. The CRL states that additional efficacy data are required to support an approval. An ongoing phase III study (in biologic-naïve patients) continues to enroll patients, with results expected in late 2024.
During the quarter, the FDA approved Veopoz (pozelimab-bbfg), an antibody to C5, for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy.
Our Take
Regeneron’s third-quarter results beat estimates, but Eylea’s sales declined. Eylea sales have been under pressure in the last couple of quarters due to competition from Roche’s Vabysmo.
Nevertheless, the company should benefit from Dupixent’s continued label expansions and solid demand. The approval of Eylea HD is a great boost to the company. The company’s progress with the oncology portfolio is also impressive.
Image: Bigstock
Regeneron (REGN) Q3 Earnings & Sales Top, Eylea Sales Decline
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) delivered better-than-expected third-quarter 2023 results, even though lead drug Eylea’s (aflibercept) sales declined. Dupixent maintained its stellar performance, driven by continued strong demand in the approved indications, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.
Regeneron’s shares have gained 9.7% in the year so far against the industry’s decline of 23.5%.
Image Source: Zacks Investment Research
The company reported third-quarter earnings of $11.59 per share, comfortably beating the Zacks Consensus Estimate of $10.8. The year-ago quarter recorded earnings per share of $11.14.
Total revenues in the reported quarter were up 15% year over year to $3.36 billion, beating the Zacks Consensus Estimate of $3.23 billion.
Quarterly Highlights
Lead drug Eylea’s sales in the United States were $1.45 billion, down 11% year over year, primarily due to increased competition. Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . Eylea’s sales also missed the Zacks Consensus Estimate of $1.54 billion.
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.
In August 2023, the FDA approved Eylea HD (higher dose of Eylea) for the treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy and Regeneron commenced recording sales in the United States in the third quarter of 2023.
Total revenues include collaboration revenues of $1.4 billion from Sanofi (SNY - Free Report) and Bayer, up from $1 billion in the year-ago quarter. Sanofi’s collaboration revenues increased by 50% to $1 billion, driven by profits associated with higher Dupixent sales. We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with global sales of both drugs. Dupixent’s sales surged 33% year over year to $3.1 billion.
Bayer’s collaboration revenues came in at $377 million, up 13% from the year-ago quarter.
Regeneron records net product sales of Praluent in the United States and Sanofi records net product sales of Praluent outside the United States and pays REGN a royalty on such sales. Prior to Jul 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi recorded net product sales of Libtayo outside the United States. Effective Jul 1, 2022, Regeneron records global net product sales of Libtayo outside the United States and pays a royalty to Sanofi on such sales.
Total Libtayo sales came in at $232 million. Praluent’s net sales in the United States came in at $40.3 million in the reported quarter, up 33% year over year. Kevzara recorded sales of $95.7 million, up 9% from the year-ago quarter.
REGEN-COV, its antibody cocktail for COVID-19, did not generate any sales in the quarter. Regeneron records net product sales of REGEN-COV in connection with its agreements with the U.S. government, and its partner Roche (RHHBY - Free Report) records net product sales of the antibody cocktail outside the United States. The companies share gross profits from global sales based on a pre-specified formula.
Adjusted R&D expenses jumped 16.9% to $954.4 million, while SG&A expenses increased 14.2% to $533.7 million in the year-ago quarter.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote
Pipeline and Regulatory Update
The FDA accepted for priority review the supplemental biologics license application (“sBLA”) for Dupixent, seeking approval of the drug for the treatment of children aged 1 to 11 years with eosinophilic esophagitis. The regulatory body set a target action date of Jan 31, 2024.
In October 2023, the FDA issued a Complete Response Letter (“CRL”) for the sBLA for Dupixent in chronic spontaneous urticaria. The CRL states that additional efficacy data are required to support an approval. An ongoing phase III study (in biologic-naïve patients) continues to enroll patients, with results expected in late 2024.
During the quarter, the FDA approved Veopoz (pozelimab-bbfg), an antibody to C5, for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy.
Our Take
Regeneron’s third-quarter results beat estimates, but Eylea’s sales declined. Eylea sales have been under pressure in the last couple of quarters due to competition from Roche’s Vabysmo.
Nevertheless, the company should benefit from Dupixent’s continued label expansions and solid demand. The approval of Eylea HD is a great boost to the company. The company’s progress with the oncology portfolio is also impressive.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.