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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) reported better-than-expected results for the third quarter of 2020, beating both earnings and sales estimates. Evidently, shares of the company are up in pre-market trading.
In fact, the stock has rallied 56.4% so far this year against the industry’s decrease of 6.3%.
Regeneron reported earnings of $8.36 per share in the third quarter, comprehensively beating the Zacks Consensus Estimate of $7.23 and also increasing from $6.67 in the year-ago quarter.
Total revenues in the reported quarter surged 32% year over year to $2.29 billion. The top line also surpassed the Zacks Consensus Estimate of $2.14 billion. This year-over-year growth was particularly driven by strong Eylea and Dupixent sales.
Quarterly Highlights
Net product sales increased to $1.48 billion in the quarter under review, up from $1.23 billion in the year-ago quarter. Lead drug Eylea’s sales in the United States were $1.32 billion compared with $1.19 billion in the year-ago quarter. Per the company, the inventory levels of Eylea in the United States were within the targeted range.
Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . The company is solely responsible for the sales and profits of this promising eye drug in the United States. However, Regeneron shares profits/losses on Eylea sales equally with Bayer in the ex-U.S. markets except in Japan where the company receives a royalty on net sales.
Total revenues of $653 million also included Sanofi (SNY - Free Report) and Bayer’s collaboration revenues compared with $469 million in the year-earlier quarter. This increase was primarily owing to higher net product sales of Dupixent. Moreover, during this time, Regeneron earned a sales-based milestone fee of $50 million from Sanofi, triggered by the annual sales of antibodies in the ex-U.S. markets, exceeding $1 billion on a rolling twelve-month basis.
Notably, Regeneron records net product sales of Libtayo in the United States. Sanofi records net product sales of Libtayo outside the country and global net product sales of Dupixent, Kevzara and Zaltrap. Regeneron records its share of profits/losses in connection with the sales of Libtayo outside the United States, and global sales of Dupixent and Kevzara within collaboration revenues.
Dupixent’s sales summed $1.07 billion, up from $633.1 million in the year-ago quarter. Kevzara recorded sales of $70 million, up from $54.8 million in the year-earlier quarter.
Praluent’s global net sales totaled $91.5 million in the reported quarter, up from $69.7 million in the prior-year quarter.
Libtayo sales in the quarter totaled $96.1 million, up from $51.5 million in the prior-year quarter.
R&D expenses increased to $628.7 million from $466 million while SG&A expenses grew to $291 million during the quarter from $263.6 million in the year-ago period.
COVID-19 Update
In October 2020, Regeneron submitted a request to the FDA for an Emergency Use Authorization (EUA) for its experimental COVID-19 treatment REGN-COV2 in patients with mild-to-moderate COVID-19 who are at risk for poor outcomes.
REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987).
During the same month, the company announced positive, prospective results from an ongoing phase II/III seamless study evaluating REGN-COV2 in the COVID-19 outpatient setting. The investigational antibody cocktail REGN-COV2 met the primary and key secondary endpoints. REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits).
Other Pipeline Updates
Notably, regulatory submissions for Dupixent as a treatment of moderate-to-severe asthma in children aged from six years to 11 years are expected to be filed by the first quarter of 2021, both in the United States and the EU. Dupixent has already been granted a Breakthrough Therapy designation by the FDA for treating eosinophilic esophagitis in patients aged 12 years and above.
Notably, Libtayo is under a priority review in the United States as a monotherapy to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with a decision from the FDA expected on Feb 28, 2021. The drug is also under a priority review for the treatment of patients with locally advanced or metastatic basal cell carcinoma (BCC) with a decision from the FDA expected on Mar 3, 2021.
Additionally, in October 2020, the FDA approved Regeneron’s triple antibody cocktail REGN-EB3 for the treatment of the infection caused by Zaire ebolavirus in adult and pediatric patients. The patient population includes newborns of mothers who tested positive for the infection. The drug was marketed under the brand name Inmazeb.
Our Take
Regeneron’s third-quarter results were impressive as the company beat on both sales and earnings, driven by strong Dupixent and Eylea growth. The company’s efforts to expand the label of its approved drugs and concurrently develop the pipeline are pretty appreciating. Regeneron’s efforts to develop REGN-COV2 are encouraging and if successfully developed and approved, it should drive growth further.
Though overall demand for Eylea in the United States stabilized and grew in the third quarter, the drug is likely to face stiff competition from Novartis AG’s (NVS - Free Report) Beovu.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
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Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
Image: Bigstock
Regeneron's (REGN) Q3 Earnings & Sales Surpass Estimates
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) reported better-than-expected results for the third quarter of 2020, beating both earnings and sales estimates. Evidently, shares of the company are up in pre-market trading.
In fact, the stock has rallied 56.4% so far this year against the industry’s decrease of 6.3%.
Regeneron reported earnings of $8.36 per share in the third quarter, comprehensively beating the Zacks Consensus Estimate of $7.23 and also increasing from $6.67 in the year-ago quarter.
Total revenues in the reported quarter surged 32% year over year to $2.29 billion. The top line also surpassed the Zacks Consensus Estimate of $2.14 billion. This year-over-year growth was particularly driven by strong Eylea and Dupixent sales.
Quarterly Highlights
Net product sales increased to $1.48 billion in the quarter under review, up from $1.23 billion in the year-ago quarter. Lead drug Eylea’s sales in the United States were $1.32 billion compared with $1.19 billion in the year-ago quarter. Per the company, the inventory levels of Eylea in the United States were within the targeted range.
Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . The company is solely responsible for the sales and profits of this promising eye drug in the United States. However, Regeneron shares profits/losses on Eylea sales equally with Bayer in the ex-U.S. markets except in Japan where the company receives a royalty on net sales.
Total revenues of $653 million also included Sanofi (SNY - Free Report) and Bayer’s collaboration revenues compared with $469 million in the year-earlier quarter. This increase was primarily owing to higher net product sales of Dupixent. Moreover, during this time, Regeneron earned a sales-based milestone fee of $50 million from Sanofi, triggered by the annual sales of antibodies in the ex-U.S. markets, exceeding $1 billion on a rolling twelve-month basis.
Notably, Regeneron records net product sales of Libtayo in the United States. Sanofi records net product sales of Libtayo outside the country and global net product sales of Dupixent, Kevzara and Zaltrap. Regeneron records its share of profits/losses in connection with the sales of Libtayo outside the United States, and global sales of Dupixent and Kevzara within collaboration revenues.
Dupixent’s sales summed $1.07 billion, up from $633.1 million in the year-ago quarter. Kevzara recorded sales of $70 million, up from $54.8 million in the year-earlier quarter.
Praluent’s global net sales totaled $91.5 million in the reported quarter, up from $69.7 million in the prior-year quarter.
Libtayo sales in the quarter totaled $96.1 million, up from $51.5 million in the prior-year quarter.
R&D expenses increased to $628.7 million from $466 million while SG&A expenses grew to $291 million during the quarter from $263.6 million in the year-ago period.
COVID-19 Update
In October 2020, Regeneron submitted a request to the FDA for an Emergency Use Authorization (EUA) for its experimental COVID-19 treatment REGN-COV2 in patients with mild-to-moderate COVID-19 who are at risk for poor outcomes.
REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987).
During the same month, the company announced positive, prospective results from an ongoing phase II/III seamless study evaluating REGN-COV2 in the COVID-19 outpatient setting. The investigational antibody cocktail REGN-COV2 met the primary and key secondary endpoints. REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits).
Other Pipeline Updates
Notably, regulatory submissions for Dupixent as a treatment of moderate-to-severe asthma in children aged from six years to 11 years are expected to be filed by the first quarter of 2021, both in the United States and the EU. Dupixent has already been granted a Breakthrough Therapy designation by the FDA for treating eosinophilic esophagitis in patients aged 12 years and above.
Notably, Libtayo is under a priority review in the United States as a monotherapy to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with a decision from the FDA expected on Feb 28, 2021. The drug is also under a priority review for the treatment of patients with locally advanced or metastatic basal cell carcinoma (BCC) with a decision from the FDA expected on Mar 3, 2021.
Additionally, in October 2020, the FDA approved Regeneron’s triple antibody cocktail REGN-EB3 for the treatment of the infection caused by Zaire ebolavirus in adult and pediatric patients. The patient population includes newborns of mothers who tested positive for the infection. The drug was marketed under the brand name Inmazeb.
Our Take
Regeneron’s third-quarter results were impressive as the company beat on both sales and earnings, driven by strong Dupixent and Eylea growth. The company’s efforts to expand the label of its approved drugs and concurrently develop the pipeline are pretty appreciating. Regeneron’s efforts to develop REGN-COV2 are encouraging and if successfully developed and approved, it should drive growth further.
Though overall demand for Eylea in the United States stabilized and grew in the third quarter, the drug is likely to face stiff competition from Novartis AG’s (NVS - Free Report) Beovu.
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.
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
See the 5 high-tech stocks now>>