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Regeneron (REGN) Q3 Earnings & Sales Beat on Eylea, Dupixent
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) delivered better-than-expected third-quarter 2022 results. It beat estimates for both earnings and sales, driven by growth in Eylea and Dupixent and progress on launches in pediatric atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
Regeneron’s shares have gained 17.3% in the year so far against the industry’s decline of 22.2%.
Image Source: Zacks Investment Research
Regeneron reported third-quarter earnings of $11.14 per share, comfortably beating the Zacks Consensus Estimate of $9.65. The year-ago quarter recorded earnings per share of $15.37 due to higher sales.
Total revenues in the reported quarter were down 15% year aover year to $2.9 billion but beat the Zacks Consensus Estimate of $2.8 billion. Excluding REGEN-COV (a cocktail of two monoclonal antibodies — casirivimab and imdevimab) for COVID-19, sales increased 11%.
In January 2022, the FDA revised the authorizations for a few monoclonal antibody treatments, including Regeneron’s REGEN-COV (casirivimab and imdevimab), as data indicated that these treatments are highly unlikely to be active against the Omicron variant. Therefore, REGEN-COV is currently not currently authorized for use in U.S. states, territories or jurisdictions.
Quarterly Highlights
Lead drug Eylea’s sales in the United States were $1.6 billion compared with $1.5 billion in the year-ago quarter. Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . Eylea sales missed the Zacks Consensus Estimate of $1.7 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.
Total revenues also included collaboration revenues of $1 billion from Sanofi (SNY - Free Report) , Bayer and Roche (RHHBY - Free Report) , down from $1.1 billion in the year-ago quarter. Sanofi’s collaboration revenues amounted to $711 million, up from $582 million. Bayer’s collaboration revenues came in at $333 million, down from $365 million. Roche’s collaboration revenues totaled $6 million compared with $127 million in the year-ago quarter due to lower sales of Ronapreve.
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. 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 the company a royalty on such sales. Regeneron records net product sales of REGEN-COV in connection with its agreements with the U.S. government, while partner Roche 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.
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.
Dupixent’s sales surged to $2.3 billion from $1.7 billion in the year-ago quarter. Total Libtayo sales came in at $143 million, up from $119.5 million. Kevzara recorded sales of $88.1 million, down from $97.8 million.
Praluent’s global net sales totaled $113.7 million in the reported quarter, down from $114.5 million in the prior-year quarter.
REGEN-COV, its antibody cocktail for COVID-19, generated total sales of $22.8 million in the quarter outside of the United States.
Adjusted R&D expenses increased to $816.6 million from $592.3 million, while SG&A expenses jumped to $467.3 million from $390.7 million in the year-ago quarter.
Pipeline and Regulatory Update
The primary endpoints were achieved in two trials investigating aflibercept 8 mg with 12- and 16-week dosing regimens in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (wet AMD). The PHOTON trial in DME and the PULSAR trial in wet AMD both demonstrated that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the Eylea 8-week dosing regimen.
The FDA accepted for priority review the supplemental biologics license application for Eylea to treat retinopathy of prematurity in preterm infants, with a target action date of Feb 11, 2023. The regulatory body also granted pediatric exclusivity to Eylea, extending its period of U.S. market exclusivity by an additional six months through May 17, 2024.
In September 2022, the FDA approved Dupixent for the treatment of adult patients with prurigo nodularis, making Dupixent the first and only medicine specifically indicated to treat prurigo nodularis in the United States.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Regeneron’s third-quarter results were strong, reflecting broad-based growth. Solid demand for Eylea and Dupixent maintained momentum for the company.
Growth in Eylea and Dupixent through further penetration in existing indications and a promising late-stage pipeline set the momentum for growth. The company’s progress with the oncology portfolio is also impressive.
Image: Bigstock
Regeneron (REGN) Q3 Earnings & Sales Beat on Eylea, Dupixent
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) delivered better-than-expected third-quarter 2022 results. It beat estimates for both earnings and sales, driven by growth in Eylea and Dupixent and progress on launches in pediatric atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
Regeneron’s shares have gained 17.3% in the year so far against the industry’s decline of 22.2%.
Image Source: Zacks Investment Research
Regeneron reported third-quarter earnings of $11.14 per share, comfortably beating the Zacks Consensus Estimate of $9.65. The year-ago quarter recorded earnings per share of $15.37 due to higher sales.
Total revenues in the reported quarter were down 15% year aover year to $2.9 billion but beat the Zacks Consensus Estimate of $2.8 billion. Excluding REGEN-COV (a cocktail of two monoclonal antibodies — casirivimab and imdevimab) for COVID-19, sales increased 11%.
In January 2022, the FDA revised the authorizations for a few monoclonal antibody treatments, including Regeneron’s REGEN-COV (casirivimab and imdevimab), as data indicated that these treatments are highly unlikely to be active against the Omicron variant. Therefore, REGEN-COV is currently not currently authorized for use in U.S. states, territories or jurisdictions.
Quarterly Highlights
Lead drug Eylea’s sales in the United States were $1.6 billion compared with $1.5 billion in the year-ago quarter. Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . Eylea sales missed the Zacks Consensus Estimate of $1.7 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.
Total revenues also included collaboration revenues of $1 billion from Sanofi (SNY - Free Report) , Bayer and Roche (RHHBY - Free Report) , down from $1.1 billion in the year-ago quarter. Sanofi’s collaboration revenues amounted to $711 million, up from $582 million. Bayer’s collaboration revenues came in at $333 million, down from $365 million. Roche’s collaboration revenues totaled $6 million compared with $127 million in the year-ago quarter due to lower sales of Ronapreve.
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. 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 the company a royalty on such sales. Regeneron records net product sales of REGEN-COV in connection with its agreements with the U.S. government, while partner Roche 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.
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.
Dupixent’s sales surged to $2.3 billion from $1.7 billion in the year-ago quarter. Total Libtayo sales came in at $143 million, up from $119.5 million. Kevzara recorded sales of $88.1 million, down from $97.8 million.
Praluent’s global net sales totaled $113.7 million in the reported quarter, down from $114.5 million in the prior-year quarter.
REGEN-COV, its antibody cocktail for COVID-19, generated total sales of $22.8 million in the quarter outside of the United States.
Adjusted R&D expenses increased to $816.6 million from $592.3 million, while SG&A expenses jumped to $467.3 million from $390.7 million in the year-ago quarter.
Pipeline and Regulatory Update
The primary endpoints were achieved in two trials investigating aflibercept 8 mg with 12- and 16-week dosing regimens in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (wet AMD). The PHOTON trial in DME and the PULSAR trial in wet AMD both demonstrated that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the Eylea 8-week dosing regimen.
The FDA accepted for priority review the supplemental biologics license application for Eylea to treat retinopathy of prematurity in preterm infants, with a target action date of Feb 11, 2023. The regulatory body also granted pediatric exclusivity to Eylea, extending its period of U.S. market exclusivity by an additional six months through May 17, 2024.
In September 2022, the FDA approved Dupixent for the treatment of adult patients with prurigo nodularis, making Dupixent the first and only medicine specifically indicated to treat prurigo nodularis in the United States.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote
Our Take
Regeneron’s third-quarter results were strong, reflecting broad-based growth. Solid demand for Eylea and Dupixent maintained momentum for the company.
Growth in Eylea and Dupixent through further penetration in existing indications and a promising late-stage pipeline set the momentum for growth. 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