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Regeneron (REGN) Tops Q1 Earnings, Ups 2016 Eylea View

Regeneron Pharmaceuticals, Inc. REGN reported first-quarter 2016 earnings (including share-based compensation expenses and tax adjustments) of $1.45 per share, significantly ahead of the Zacks Consensus Estimate of $1.24. Earnings were however down from $1.99 per share earned in the year-ago quarter.

Excluding share-based compensation expenses, the company’s earnings were down 11% to $2.57 per share.

Total revenue in the reported quarter soared 38% year over year to $1.20 billion driven by strong sales of the eye drug, Eylea, as well as higher collaboration revenues. We note that Regeneron has co-developed Eylea with the HealthCare unit of Bayer AG BAYRY. Regeneron is solely responsible for the U.S. sales of the eye drug and is entitled to the entire U.S. profits. However, it shares profits and losses equally with Bayer from ex-U.S. Eylea sales, except Japan, where Regeneron receives a royalty on net sales.

Revenues were slightly above the Zacks Consensus Estimate of $1.18 billion.

Quarterly Highlights

Total revenues consist mainly of net product sales and collaboration revenues. Net product sales increased to $784 million in the quarter from $545 million a year ago. The majority of sales came from Eylea in the U.S. ($781 million, up 44%). Sales of Eylea in ex-U.S. markets were $419 million compared with $292 million in the first quarter of 2015.

Collaboration revenues came in at $399 million in the quarter, compared with $297 million a year ago. Collaboration revenues in the first quarter of 2016 increased primarily due to higher reimbursement of the company's research and development expenses (R&D) under its antibody collaboration with Sanofi SNY, an increase in net profit from Eylea sales in ex-U.S. markets and reimbursement of R&D expenses and amortization of upfront payments received in connection with the Jul 2015 immuno-oncology collaboration with Sanofi.

Regeneron received a major boost when its PCSK9 inhibitor, Praluent, which it has co-developed with Sanofi, gained approval in the U.S. Praluent generated revenues of $13 million in the reported quarter.

Regeneron is developing 13 human monoclonal antibodies utilizing its VelocImmune technology. The company is developing four of the antibodies in partnership with Sanofi.

Both R&D and selling, general and administrative (SG&A) expenses increased during the reported quarter.

2016 Eylea Outlook Updated

Regeneron raised the Eylea U.S. net sales guidance for 2016. The company now expects U.S. Eylea net sales to grow 20–25% year over year. Previously, it had anticipated Eylea sales to grow approximately 20% year over year.

However, the company continues to expect adjusted unreimbursed R&D expenses in the range of $875 million to $950 million. Adjusted SG&A costs are still projected in the band of $925 million to $1 billion.

Our Take

Regeneron’s first-quarter results were encouraging with the company beating both top- and bottom-line estimates. This was largely due to the outperformance of Eylea. Moreover, the company’s raised outlook for the U.S. sales of Eylea is encouraging. We expect investor focus to remain on the performance of Eylea as well as Praluent.

Regeneron is a Zack Rank #3 (Hold) stock. ANI Pharmaceuticals, Inc. ANIP is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy).

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