Back to top

Analyst Blog

This page is temporarily not available.  Please check later as it should be available shortly. If you have any questions, please email customer support at support@zacks.com or call 800-767-3771 ext.  9339.

Eye-drug Eylea is Regeneron Pharmaceuticals, Inc.’s (REGN - Analyst Report) primary growth driver. Sales of the drug have been on the rise ever since its U.S. launch in late 2011 for the age-related macular degeneration (wet AMD) indication. We note that Eylea is approved for wet AMD in approximately 50 countries across the globe.

Sales of Eylea in the U.S. climbed 49% in the third quarter of 2013 to $363 million. Sales in ex-U.S. markets were $125 million, as reported by partner Bayer (BAYRY - Analyst Report). As per the agreement with Bayer, Regeneron is solely responsible for the U.S. sales of the eye drug. The company is entitled to the entire profits arising from the U.S. sales of Eylea. Regeneron and Bayer equally share the profits and losses from ex-US Eylea sales, except for Japan where Regeneron receives a royalty on net sales.

Based on its bullish expectation, Regeneron raised its forecast for 2013 Eylea sales. Regeneron now expects 2013 sales of Eylea in the range of $1.35–$1.375 billion (old guidance: $1.3–$1.35 billion). We expect Regeneron to achieve the guidance on Eylea. In Sep 2012, the U.S. Food and Drug Administration (FDA) approved the label expansion of Eylea into macular edema following CRVO indication. Japanese approval for the CRVO indication came in Nov 2013.

The U.S. label expansion of Eylea into the CRVO indication has further boosted its sales potential. This should strengthen Regeneron’s top line further.

Regeneron is looking to expand Eylea’s label further into the diabetic macular edema (DME) – a leading cause of blindness. Regeneron’s supplemental biologics license application (sBLA) seeking U.S. approval of Eylea in the new indication is under FDA review. A decision from the U.S. regulatory body is expected by Aug. 18, 2014. U.S. approval for the new indication was sought on the basis of positive data from two phase III studies- VIVID and VISTA. EU approval for the indication was sought in Nov 2013. Approval of Eylea for the DME indication will boost the eye drug’s sales potential further.

Regeneron, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biopharma space are Jazz Pharmaceuticals (JAZZ - Analyst Report) and Vanda Pharmaceuticals Inc. (VNDA - Snapshot Report). Both stocks carry a Zacks Rank #1 (Strong Buy).

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

Learn more

Start for as little as $4.50 per trade.

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
DIXIE GROUP DXYN 15.84 +7.90%
BOFL HOLDING BOFI 85.30 +4.97%
RAMBUS INC RMBS 12.31 +4.41%
VIPSHOP HOLD VIPS 148.73 +4.35%
NETFLIX INC NFLX 345.74 +4.32%