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Regeneron (REGN) Beats on Q4 Earnings, Gains on REGEN-COV
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) reported strong fourth-quarter 2021 results, with earnings and sales beating estimates on strong growth in Eylea and Dupixent. Contribution from REGEN-COV, its antibody cocktail for COVID-19, also boosted the top line.
Regeneron reported fourth-quarter earnings of $23.72 per share, beating the Zacks Consensus Estimate of $18.49. Earnings surged significantly year-over-year owing to higher sales of REGEN-COV.
Total revenues in the fourth quarter soared 104% year over year to $4.95 billion and beat the Zacks Consensus Estimate of $4.59 billion. The upside was primarily driven by incremental contribution from REGEN-COV (a mixture of two monoclonal antibodies — casirivimab and imdevimab). Total revenues, excluding REGEN-COV, increased 17% to $2.65 billion.
Shares of Regeneron have rallied 24.4% in the past year against the industry’s decline of 38.8%.
Image Source: Zacks Investment Research
Full-Year Results
For 2021, Regeneron generated revenues of $16.07 billion, up 89% on the back of solid performance from REGEN-COV. Excluding REGEN-COV, total revenues rose 19% in 2021.
In 2021, the company reported earnings of $74.66 per share, up 137% year over year.
Quarterly Highlights
Lead drug Eylea’s sales in the United States were $1.54 billion compared with $1.34 billion in the year-ago quarter. 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. Bayer records net product sales of Eylea in ex-U.S. markets. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States. Eylea generated worldwide sales of $2.48 billion in the fourth quarter.
Total revenues also included collaboration revenues of $890.3 million from Sanofi (SNY - Free Report) , Bayer and Roche (RHHBY - Free Report) , up from $677.7 million in the year-ago quarter. Sanofi’s collaboration revenues amounted to $517.9 million, up from $317.1 million in the year-ago quarter. Bayer’s collaboration revenues came in at $372.4 million, up from $360.6 million in the year-ago quarter.
Per the press release, the company did not record any collaboration revenue from Roche in the fourth quarter as Regeneron owed a true-up payment to the latter related to global gross profits from sales of the antibody cocktail, which was recorded as cost of goods sold.
Sanofi records global net product sales of Dupixent, Kevzara, and ZALTRAP. Regeneron records its share of profits/losses in connection with global sales of Dupixent and Kevzara. Sanofi pays the company a percentage of net sales of ZALTRAP.
Total Dupixent sales surged to $1.77 billion from $1.17 billion in the year-ago quarter.
Regeneron records net product sales of Libtayo in the United States and Sanofi records the same outside the country. Both the companies equally share profits/losses in connection with global sales of Libtayo.
Libtayo sales in the United States came in at $80.8 million, up from $74.1 million. Kevzara recorded total sales of $103.9 million, up from $71.5 million in the year-ago quarter.
Praluent’s global net sales totaled $102.6 million in the reported quarter, up from $100.9 million in the prior-year quarter. Regeneron records net product sales of Praluent in the United States and Sanofi records the same outside the country and pays the former a royalty on such sales.
Adjusted R&D expenses declined to $639 million from $675 million. Adjusted SG&A expenses jumped to $495 million from $381 million in the year-ago quarter.
REGEN-COV generated total sales of $2.87 billion in the fourth quarter. Sales in the United States came in at $2.29 billion.
REGEN-COV Updates
During the fourth quarter, Regeneron completed the final deliveries of the drug product under its agreement with the U.S. government, supplying an additional 1.1 million doses of REGEN-COV, recording $2.30 billion in sales from the same.
REGEN-COV received an Emergency Use Authorization from the FDA in November 2020 for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.
In January 2022, the FDA revised the emergency use authorization for REGEN-COV and Eli Lilly’s antibody cocktail – (bamlanivimab plus etesevimab).
The FDA decided to limit the authorized use of Regeneron and Lilly’s cocktail COVID-19 drugs as these treatment options are highly unlikely to be effective against the Omicron variant in the United States. This decision is expected to hurt sales of Regeneron’s cocktail antibody in future quarters.
Pipeline and Regulatory Update
Last month, Regeneron and Sanofi announced that they have voluntarily withdrawn the supplemental biologics license application (sBLA) for Libtayo as a second-line treatment for patients with advanced cervical cancer. The decision was taken after the two companies and the FDA could not align on certain post-marketing studies.
In January 2022, the FDA accepted for review the sBLA for Libtayo in combination with chemotherapy as first-line treatment in advanced non-small-cell lung cancer. The regulatory body had set an action date of Sep 19, 2022.
Our Take
Regeneron’s fourth-quarter results were strong with broad-based growth. Strong demand for Eylea and Dupixent maintained momentum for the company. Solid contribution from REGEN-COV has boosted the top line significantly and should propel sales as the pandemic continues. Continued growth in Eylea and Dupixent through further penetration in existing indications and a promising late-stage pipeline is likely to carry the momentum for growth in 2022. However, the lack of efficacy of REGEN-COV against the Omicron variant and the decision to withdraw the sBLA for Libtayo in cervical cancer is likely to hurt sales in the days ahead.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Image: Bigstock
Regeneron (REGN) Beats on Q4 Earnings, Gains on REGEN-COV
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) reported strong fourth-quarter 2021 results, with earnings and sales beating estimates on strong growth in Eylea and Dupixent. Contribution from REGEN-COV, its antibody cocktail for COVID-19, also boosted the top line.
Regeneron reported fourth-quarter earnings of $23.72 per share, beating the Zacks Consensus Estimate of $18.49. Earnings surged significantly year-over-year owing to higher sales of REGEN-COV.
Total revenues in the fourth quarter soared 104% year over year to $4.95 billion and beat the Zacks Consensus Estimate of $4.59 billion. The upside was primarily driven by incremental contribution from REGEN-COV (a mixture of two monoclonal antibodies — casirivimab and imdevimab). Total revenues, excluding REGEN-COV, increased 17% to $2.65 billion.
Shares of Regeneron have rallied 24.4% in the past year against the industry’s decline of 38.8%.
Full-Year Results
For 2021, Regeneron generated revenues of $16.07 billion, up 89% on the back of solid performance from REGEN-COV. Excluding REGEN-COV, total revenues rose 19% in 2021.
In 2021, the company reported earnings of $74.66 per share, up 137% year over year.
Quarterly Highlights
Lead drug Eylea’s sales in the United States were $1.54 billion compared with $1.34 billion in the year-ago quarter. 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. Bayer records net product sales of Eylea in ex-U.S. markets. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States. Eylea generated worldwide sales of $2.48 billion in the fourth quarter.
Total revenues also included collaboration revenues of $890.3 million from Sanofi (SNY - Free Report) , Bayer and Roche (RHHBY - Free Report) , up from $677.7 million in the year-ago quarter. Sanofi’s collaboration revenues amounted to $517.9 million, up from $317.1 million in the year-ago quarter. Bayer’s collaboration revenues came in at $372.4 million, up from $360.6 million in the year-ago quarter.
Per the press release, the company did not record any collaboration revenue from Roche in the fourth quarter as Regeneron owed a true-up payment to the latter related to global gross profits from sales of the antibody cocktail, which was recorded as cost of goods sold.
Sanofi records global net product sales of Dupixent, Kevzara, and ZALTRAP. Regeneron records its share of profits/losses in connection with global sales of Dupixent and Kevzara. Sanofi pays the company a percentage of net sales of ZALTRAP.
Total Dupixent sales surged to $1.77 billion from $1.17 billion in the year-ago quarter.
Regeneron records net product sales of Libtayo in the United States and Sanofi records the same outside the country. Both the companies equally share profits/losses in connection with global sales of Libtayo.
Libtayo sales in the United States came in at $80.8 million, up from $74.1 million. Kevzara recorded total sales of $103.9 million, up from $71.5 million in the year-ago quarter.
Praluent’s global net sales totaled $102.6 million in the reported quarter, up from $100.9 million in the prior-year quarter. Regeneron records net product sales of Praluent in the United States and Sanofi records the same outside the country and pays the former a royalty on such sales.
Adjusted R&D expenses declined to $639 million from $675 million. Adjusted SG&A expenses jumped to $495 million from $381 million in the year-ago quarter.
REGEN-COV generated total sales of $2.87 billion in the fourth quarter. Sales in the United States came in at $2.29 billion.
REGEN-COV Updates
During the fourth quarter, Regeneron completed the final deliveries of the drug product under its agreement with the U.S. government, supplying an additional 1.1 million doses of REGEN-COV, recording $2.30 billion in sales from the same.
REGEN-COV received an Emergency Use Authorization from the FDA in November 2020 for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.
In January 2022, the FDA revised the emergency use authorization for REGEN-COV and Eli Lilly’s antibody cocktail – (bamlanivimab plus etesevimab).
The FDA decided to limit the authorized use of Regeneron and Lilly’s cocktail COVID-19 drugs as these treatment options are highly unlikely to be effective against the Omicron variant in the United States. This decision is expected to hurt sales of Regeneron’s cocktail antibody in future quarters.
Pipeline and Regulatory Update
Last month, Regeneron and Sanofi announced that they have voluntarily withdrawn the supplemental biologics license application (sBLA) for Libtayo as a second-line treatment for patients with advanced cervical cancer. The decision was taken after the two companies and the FDA could not align on certain post-marketing studies.
In January 2022, the FDA accepted for review the sBLA for Libtayo in combination with chemotherapy as first-line treatment in advanced non-small-cell lung cancer. The regulatory body had set an action date of Sep 19, 2022.
Our Take
Regeneron’s fourth-quarter results were strong with broad-based growth. Strong demand for Eylea and Dupixent maintained momentum for the company. Solid contribution from REGEN-COV has boosted the top line significantly and should propel sales as the pandemic continues. Continued growth in Eylea and Dupixent through further penetration in existing indications and a promising late-stage pipeline is likely to carry the momentum for growth in 2022. However, the lack of efficacy of REGEN-COV against the Omicron variant and the decision to withdraw the sBLA for Libtayo in cervical cancer is likely to hurt sales in the days ahead.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote
Zacks Rank
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.