BIOPHARMA

Regeneron’s First-Quarter Earnings Beat as its Eylea (aflibercept) Eye Drug Global Sales Jumped 44%

Witawat (Ed) Wijaranakula, Ph.D.
Thu May 7, 2015

In the first-quarter ended March 2015, Regeneron Pharmaceuticals [NASDAQ:REGN] reported total revenues of $869.6 million, up 39% year-over-year and non-GAAP (adjusted) EPS of $2.88, up 27% year-over-year. Wall Street was expecting earnings of $2.68 per share on revenue of $824.6 million. The company reported Eylea sales in the United States of $541 million, up 51% year-on-year. The company said that it now expects U.S. Eylea sales to rise 30% to 35% this year, up from its previous guidance of 25% to 30%.

Bayer HealthCare [OTCMKTS:BAYRY] collaboration revenue was $123.8 million in the first-quarter 2015, down 1.2% year-over-year from $125.3 million, as Regeneron received less sales milestones payments and lower cost-sharing of Regeneron development expenses compared to the year-ago quarter. Regeneron and Bayer HealthCare commercializes Eylea outside the United States, except for Japan, where Regeneron receives a royalty on net sales. 

In the first-quarter of 2015, net sales of Eylea outside of the United States were $292 million, up 34% from $218 million in the first-quarter of 2014. Regeneron recognized $89 million from its share of net profits from Eylea sales outside the United States, up 46% from $61 million in the first-quarter of 2014. 

Sanofi [NYSE:SNY] collaboration revenue in the first quarter 2015 was $173.4 million, up 33% year-over-year from $130.5 million, primarily due to higher reimbursement of Regeneron's development expenses under its antibody collaboration with Sanofi. As of June 2014, Sanofi holds approximately 22.5% of Regeneron’s shares outstanding. 

In January 2015, the FDA accepted the biologics license application (BLA) for Praluent (alirocumab), a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) to lower low-density lipoprotein cholesterol (LDL-C), for priority review, with a target action date of July 24, 2015. The company will meet with the FDA's Endocrinologic and Metabolic Drugs Advisory Committee on June 9, 2015 to discuss the BLA for Praluent. The European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for Praluent for review in January 2015.

Praluent will be competing with evolocumab (AMG 145), another PCSK9 inhibitor drug developed by Amgen [NASDAQ:AMGN]. The FDA accepted Amgen's BLA for evolocumab in November 2014. In January, Pfizer [NYSE:PFE] said they are also developing a PCSK9 inhibitor oral pill and vaccine, bococizumab [RN 316], which now is in Phase 3.

Sarilumab, an antibody co-developed by Regeneron and Sanofi targeting IL-6R for rheumatoid arthritis, is currently being studied in the global Phase 3 SARIL-RA program. The companies plan to present new Phase 3 data in 2015 and submit a BLA in the United States by the end of 2015. Other antibody pipelines with Sanofi include Dupilumab, Fasinumab, REGN2222, REGN2176-3, REGN2810, REGN1500, and REGN1033.

From our technical viewpoint, REGN broke out of the rising wedge in March and is now moving in the ascending triangle pattern with the head resistance at $484. The 18-month price projection for the rising wedge breakout is $731, determined by adding the width at the top of the pattern to the point of breakout. 

It needs to be pointed out that REGN is traded along with the Nasdaq Biotechnology Index [NASDAQ:IBB] and may be counter traded with the Market Vectors Semiconductor ETF [NYSEARCA:SMH]. 

Morgan Stanley set its 12-month target price for REGN in February at $499.00 while Argus’ price target for REGN was raised in March from $450.00 to $500.00.

Disclosure: Long Position REGN in Portfolio

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