Regeneron Pharmaceuticals reported Q3 2014 earnings of $2.52 per share, up 6% from a year-ago. The earnings included a $34 million charge, or $0.29 per share, for its share of the purchase of a $67.5 million special voucher from BioMarin Pharmaceutical. 

The voucher could secure the new Sanofi and Regeneron cholesterol drug, alirocumab, an expedited six-month U.S. regulatory review. EYLEA® (aflibercept) global net sales increased 48% to $722 million (consisting of $445 million, up 23% in the U.S., and $277 million outside the U.S. in collaboration with Bayer HealthCare). Estimated full year 2014 EYLEA U.S. net sales tightened to $1.7 billion - $1.74 billion, from previous guidance of $1.7 billion - $1.8 billion.

Sanofi and Regeneron are expecting to file cholesterol drug, alirocumab, for FDA approval with Priority Review and the European Medicines Agency (EMA) review by the end of 2014. Amgen has filed a patent infringement lawsuit against Sanofi and Regeneron in the US District Court of Delaware, claiming the companies are infringing Amgen’s patents on monoclonal antibodies (mAbs) to proprotein convertase subtilisin/kexin type 9 (PCSK9). 

By filing the infringement lawsuit, Amgen hopes the court will grant the company an injunction to prevent Sanofi and Regeneron’s cholesterol drug, alirocumab, to be approved before Amgen’s cholesterol drug (PCSK9 inhibitor), evolocumab. Amgen’s drug was filed at the end of August 2014 for FDA approval, without Priority Review. 

Regeneron Pharmaceuticals has 4 drugs in the pipeline (Phase I-III), including Sarilumab (Phase III) - antibody targeting IL-6R for rheumatoid arthritis, Dupilumab (Phase II) - antibody that blocks signaling of IL-4 and IL-13 in atopic dermatitis, asthma, and chronic sinusitis with nasal polyps, REGN1979 (Phase I) bispecific antibody oncology and REGN910-3 (Phase I) - a combination product between antibody to Ang2 co-formulated with EYLEA in a single injection.

Regeneron is spending €220 million to revamp a former Dell plant in Ireland. The facility, with 300 employees, is expected to be online in 2016.

REGN is out performing, relative to the Nasdaq Biotechnology Index [NASDAQ:IBB], but did a pull back due to disappointing U.S. EYLEA sales and lower full year guidance. In the past 12 to 16 months, the stock has been moving in the rising wedge pattern. REGN has near-term supports at the 50-day MA (~ $360), 100-day MA (~$340) and 200-day MA (~$330). 

It needs to be pointed out that REGN is traded along with IBB and Sanofi SA [NYSE:SNY]. It may be counter traded with Amgen [NASDAQ:AMGN] and Market Vectors Semiconductor ETF [NYSEARCA:SMH]. REGN typically makes a significant move in response to headline news, such as announcements of drug approval.


DISCLOSURE: Long position