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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) delivered better-than-expected second-quarter 2023 results even though lead drug Eylea’s 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 1.4% so far this year against the industry’s decline of 13%.
Image Source: Zacks Investment Research
The company reported second-quarter earnings of $10.24 per share, comfortably beating the Zacks Consensus Estimate of $9.92. The year-ago quarter recorded earnings per share of $9.77.
Total revenues in the reported quarter were up 11% year over year to $3.1 billion, beating the Zacks Consensus Estimate of $3 billion.
Quarterly Highlights
Lead drug Eylea’s sales in the United States were $1.5 billion, down 7% year over year, primarily due to a lower net selling price driven by changing market dynamics, including 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 $1.53 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 include collaboration revenues of $1.3 billion from Sanofi (SNY - Free Report) and Bayer, up from $1 billion in the year-ago quarter. Sanofi’s collaboration revenues increased by 39% to $944 million, 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 $2.8 billion.
Bayer’s collaboration revenues came in at $377 million, up 5% 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 the company 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 $210 million, up 49%. Praluent’s global net sales totaled $140.3 million in the reported quarter, up 29% year over year. Kevzara recorded sales of $99.5 million, up 21% 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, while 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 41% to $973.6 million, while SG&A expenses increased 34.6% to $562.2 million in the year-ago quarter.
Pipeline and Regulatory Update
The FDA issued a complete response letter (CRL) to the company’s biologics license application seeking approval for the 8 mg dose strength of aflibercept for the treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.
Regeneron has reported that the cause of the CRL is only an ongoing review of inspection findings at a third-party filler, Catalent. The company reaffirmed that the CRL was not levied due to issues with the clinical efficacy or safety, trial design and labeling or drug substance manufacturing of aflibercept 8 mg. The company also stated that the FDA had not requested any additional clinical data or studies for the drug candidate.
The FDA has informed Regeneron and Catalent that certain manufacturing data and other information are required from Catalent to allow the regulatory body to approve aflibercept 8 mg. Regeneron expects that these data and information will be submitted to the FDA by mid-August 2023. The FDA plans to prioritize the review of this submission.
Regeneron anticipates a regulatory action by the FDA on the aflibercept 8 mg BLA during the third quarter of 2023.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Regeneron’s second-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 and sale deductions.
Nevertheless, the company should benefit from Dupixent’s continued label expansions and solid demand. The potential approval of aflibercept 8 mg, albeit delayed due to CRL, will be a great boost to the company. The company’s progress with the oncology portfolio is also impressive.
Regeneron currently carries a Zacks Rank #5 (Strong Sell).
Image: Bigstock
Regeneron (REGN) Q2 Earnings & Sales Top, Eylea Sales Decline
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) delivered better-than-expected second-quarter 2023 results even though lead drug Eylea’s 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 1.4% so far this year against the industry’s decline of 13%.
Image Source: Zacks Investment Research
The company reported second-quarter earnings of $10.24 per share, comfortably beating the Zacks Consensus Estimate of $9.92. The year-ago quarter recorded earnings per share of $9.77.
Total revenues in the reported quarter were up 11% year over year to $3.1 billion, beating the Zacks Consensus Estimate of $3 billion.
Quarterly Highlights
Lead drug Eylea’s sales in the United States were $1.5 billion, down 7% year over year, primarily due to a lower net selling price driven by changing market dynamics, including 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 $1.53 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 include collaboration revenues of $1.3 billion from Sanofi (SNY - Free Report) and Bayer, up from $1 billion in the year-ago quarter. Sanofi’s collaboration revenues increased by 39% to $944 million, 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 $2.8 billion.
Bayer’s collaboration revenues came in at $377 million, up 5% 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 the company 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 $210 million, up 49%. Praluent’s global net sales totaled $140.3 million in the reported quarter, up 29% year over year. Kevzara recorded sales of $99.5 million, up 21% 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, while 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 41% to $973.6 million, while SG&A expenses increased 34.6% to $562.2 million in the year-ago quarter.
Pipeline and Regulatory Update
The FDA issued a complete response letter (CRL) to the company’s biologics license application seeking approval for the 8 mg dose strength of aflibercept for the treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.
Regeneron has reported that the cause of the CRL is only an ongoing review of inspection findings at a third-party filler, Catalent. The company reaffirmed that the CRL was not levied due to issues with the clinical efficacy or safety, trial design and labeling or drug substance manufacturing of aflibercept 8 mg. The company also stated that the FDA had not requested any additional clinical data or studies for the drug candidate.
The FDA has informed Regeneron and Catalent that certain manufacturing data and other information are required from Catalent to allow the regulatory body to approve aflibercept 8 mg. Regeneron expects that these data and information will be submitted to the FDA by mid-August 2023. The FDA plans to prioritize the review of this submission.
Regeneron anticipates a regulatory action by the FDA on the aflibercept 8 mg BLA during the third quarter of 2023.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote
Our Take
Regeneron’s second-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 and sale deductions.
Nevertheless, the company should benefit from Dupixent’s continued label expansions and solid demand. The potential approval of aflibercept 8 mg, albeit delayed due to CRL, will be a great boost to the company. The company’s progress with the oncology portfolio is also impressive.
Regeneron currently carries a Zacks Rank #5 (Strong Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.