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Will Eylea, Dupixent Buoy Regeneron's (REGN) Q1 Earnings?
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) is scheduled to release first-quarter 2022 results on May 4, before the opening bell.
The company has an impressive track record. In the last reported quarter, it beat earnings expectations by 28.29%. It surpassed earnings estimates by 32.36%, on average, in the last four quarters.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Our proven model predicts an earnings beat for Regeneron this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.
Earnings ESP: Earnings ESP for Regeneron is +1.89%, as the Zacks Consensus Estimate is pegged at $9.37 and the Most Accurate Estimate is pegged at $9.55.
Zacks Rank: The company currently carries a Zacks Rank #3.
Factors at Play
A major chunk of Regeneron’s revenues comes from the sales of its key drug, Eylea, which is approved for various ophthalmology indications (neovascular age-related macular degeneration, diabetic macular edema and macular edema, among others). Eylea was developed in collaboration with Bayer AG.
Regeneron records net product sales of Eylea in the United States, while Bayer records net product sales of the drug outside the country. Regeneron also records its share of profits/losses in connection with sales of Eylea outside the United States.
Eylea sales in the previous quarter came in at $1.54 billion in the United States. Sales in the first quarter are likely to have witnessed sequential growth with the normalizing of demand. The Zacks Consensus Estimate for Eylea sales in the United States is pegged at $1.52 billion.
Apart from Eylea, investors will focus on the asthma drug Dupixent’s performance and additional label expansions, sales of which are recorded by Sanofi (SNY - Free Report) . Regeneron has a collaboration agreement with Sanofi for drugs like Dupixent and Kevzara. While sales are recorded by Sanofi, Regeneron records its share of profits/losses in connection with global sales of Dupixent and Kevzara. Revenues from Dupixent sales have been the company’s primary growth driver in the last few quarters.
Dupixent has maintained its stellar performance on continuous label expansion all through. The trend is expected to have continued in the to-be-reported quarter. Total sales in the last quarter were up 51%. Label expansion of the drug in the past few months is likely to have boosted sales further and resulted in incremental revenues for Regeneron.
Investors will focus on the performance of Libtayo and PCSK9 inhibitor Praluent. Regeneron records net product sales of Libtayo in the United States, and Sanofi records net product sales of the drug outside the country. Both the companies equally share profits/losses in connection with global sales of Libtayo. Sales of Libtayo were up 9% in the previous quarter in the United States. Sales are likely to have recorded sequential growth in the to-be-reported quarter on recent label expansions.
Effective Apr 1, 2020, Regeneron records net product sales of Praluent in the United States. Sanofi records net product sales of the drug outside the United States and pays Regeneron a royalty on such sales. Total sales in the previous quarter came in at $102.6 million. Praluent sales are likely to have recorded sequential growth in the first quarter.
Apart from these drugs, the company recorded sales of $2.3 billion in the United States from REGEN-COV in the previous quarter. REGEN-COV is a cocktail of two monoclonal antibodies (casirivimab and imdevimab, also known as REGN10933 and REGN10987, respectively).
However, 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 not currently authorized for use in any U.S. states, territories or jurisdictions. Hence, this revision is likely to have dented sales in the first quarter from this stream.
RECENT UPDATES
The European Commission has expanded the marketing authorization for Dupixent in the European Union. Dupixent will be used as an add-on maintenance treatment for children aged 6 to 11 years suffering from severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
Regeneron and Sanofi also announced the voluntary withdrawal of the supplemental biologics license application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer. The decision was made after the companies and the FDA were not able to align on certain post-marketing studies.
A phase III study (CUPID STUDY B) evaluating Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU) will be stopped due to futility, based on a pre-specified interim analysis.
Share Price Performance
Regeneron’s shares have gained 4.3% in the year so far against the industry’s decline of 22.4%.
Image Source: Zacks Investment Research
Other Stocks to Consider
Here are a couple of other drug/biotech stocks you may want to consider, as our model shows that these too have the right combination of elements to post an earnings beat this season.
Clovis boasts a mixed track record, having topped earnings estimates in two of the last four quarters and missing in the remaining two. Clovis pulled off a four-quarter earnings surprise of 1.44%, on average.
Vertex (VRTX - Free Report) has an Earnings ESP of +0.87% and a Zacks Rank #2.
Vertex topped earnings estimates in all of the last four quarters. Vertex delivered a four-quarter earnings surprise of 10.01%, on average.
Image: Bigstock
Will Eylea, Dupixent Buoy Regeneron's (REGN) Q1 Earnings?
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) is scheduled to release first-quarter 2022 results on May 4, before the opening bell.
The company has an impressive track record. In the last reported quarter, it beat earnings expectations by 28.29%. It surpassed earnings estimates by 32.36%, on average, in the last four quarters.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote
What Our Model Predicts
Our proven model predicts an earnings beat for Regeneron this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.
Earnings ESP: Earnings ESP for Regeneron is +1.89%, as the Zacks Consensus Estimate is pegged at $9.37 and the Most Accurate Estimate is pegged at $9.55.
Zacks Rank: The company currently carries a Zacks Rank #3.
Factors at Play
A major chunk of Regeneron’s revenues comes from the sales of its key drug, Eylea, which is approved for various ophthalmology indications (neovascular age-related macular degeneration, diabetic macular edema and macular edema, among others). Eylea was developed in collaboration with Bayer AG.
Regeneron records net product sales of Eylea in the United States, while Bayer records net product sales of the drug outside the country. Regeneron also records its share of profits/losses in connection with sales of Eylea outside the United States.
Eylea sales in the previous quarter came in at $1.54 billion in the United States. Sales in the first quarter are likely to have witnessed sequential growth with the normalizing of demand. The Zacks Consensus Estimate for Eylea sales in the United States is pegged at $1.52 billion.
Apart from Eylea, investors will focus on the asthma drug Dupixent’s performance and additional label expansions, sales of which are recorded by Sanofi (SNY - Free Report) . Regeneron has a collaboration agreement with Sanofi for drugs like Dupixent and Kevzara. While sales are recorded by Sanofi, Regeneron records its share of profits/losses in connection with global sales of Dupixent and Kevzara. Revenues from Dupixent sales have been the company’s primary growth driver in the last few quarters.
Dupixent has maintained its stellar performance on continuous label expansion all through. The trend is expected to have continued in the to-be-reported quarter. Total sales in the last quarter were up 51%. Label expansion of the drug in the past few months is likely to have boosted sales further and resulted in incremental revenues for Regeneron.
Investors will focus on the performance of Libtayo and PCSK9 inhibitor Praluent. Regeneron records net product sales of Libtayo in the United States, and Sanofi records net product sales of the drug outside the country. Both the companies equally share profits/losses in connection with global sales of Libtayo. Sales of Libtayo were up 9% in the previous quarter in the United States. Sales are likely to have recorded sequential growth in the to-be-reported quarter on recent label expansions.
Effective Apr 1, 2020, Regeneron records net product sales of Praluent in the United States. Sanofi records net product sales of the drug outside the United States and pays Regeneron a royalty on such sales. Total sales in the previous quarter came in at $102.6 million. Praluent sales are likely to have recorded sequential growth in the first quarter.
Apart from these drugs, the company recorded sales of $2.3 billion in the United States from REGEN-COV in the previous quarter. REGEN-COV is a cocktail of two monoclonal antibodies (casirivimab and imdevimab, also known as REGN10933 and REGN10987, respectively).
However, 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 not currently authorized for use in any U.S. states, territories or jurisdictions. Hence, this revision is likely to have dented sales in the first quarter from this stream.
RECENT UPDATES
The European Commission has expanded the marketing authorization for Dupixent in the European Union. Dupixent will be used as an add-on maintenance treatment for children aged 6 to 11 years suffering from severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
Regeneron and Sanofi also announced the voluntary withdrawal of the supplemental biologics license application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer. The decision was made after the companies and the FDA were not able to align on certain post-marketing studies.
A phase III study (CUPID STUDY B) evaluating Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU) will be stopped due to futility, based on a pre-specified interim analysis.
Share Price Performance
Regeneron’s shares have gained 4.3% in the year so far against the industry’s decline of 22.4%.
Image Source: Zacks Investment Research
Other Stocks to Consider
Here are a couple of other drug/biotech stocks you may want to consider, as our model shows that these too have the right combination of elements to post an earnings beat this season.
Clovis Oncology has an Earnings ESP of +2.33% and a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Clovis boasts a mixed track record, having topped earnings estimates in two of the last four quarters and missing in the remaining two. Clovis pulled off a four-quarter earnings surprise of 1.44%, on average.
Vertex (VRTX - Free Report) has an Earnings ESP of +0.87% and a Zacks Rank #2.
Vertex topped earnings estimates in all of the last four quarters. Vertex delivered a four-quarter earnings surprise of 10.01%, on average.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar