Shares of Regeneron Pharmaceuticals [NASDAQ:REGN] dropped 2.62% to close at $512.32 per share on Wednesday after the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), expert advisory panel of the U.S. Food and Drug Administration (FDA), voted 13 to 3 to recommend the approval of Praluent (alirocumab), a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) to lower low-density lipoprotein cholesterol (LDL-C) as benefit exceeds its risks in one or more patient populations. 

Praluent and other PCSK9 inhibitor drugs act by identifying and knocking out PCSK9 enzymes in the liver, and hence lowers the amount of low density lipoprotein (LDL) cholesterol in the blood.

Sanofi [NYSE:SNY] and Regeneron are seeking FDA approval of Praluent for treatment of patients with hypercholesterolemia whose LDL levels are insufficiently controlled by generic statins and for patients who can't handle statin therapy. The Biologics License Application for Praluent was accepted for priority review by the FDA with a target action date of July 24, 2015.

Praluent will be competing with Repatha (evolocumab), another PCSK9 inhibitor drug developed by Amgen [NASDAQ:AMGN]. The FDA accepted Amgen's BLA for Repatha in November 2014. Both Praluent and Repatha are injectable. Praluent is administrated at a dose of 75 mg every week, where low LDL-C levels are likely to be of less concern, and then move up to 150 mg when necessary. Repatha is administered at a dose of 140 mg every 2 weeks, or 420 mg once a month.

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. According to estimates compiled by analysts, the PCSK9 inhibitors have the potential to generate annual sales of as much as $3 billion.

In the first-quarter ended March 2015, Regeneron 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 sales of Eylea, its top-selling eye drug, 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 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. 

Another key antibody pipeline with Sanofi is Sarilumab, an antibody targeting IL-6R for rheumatoid arthritis, which 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. 

Last month, Sanofi and Regeneron reported positive results from an interim analysis of a pivotal Phase 2b study of dupilumab, an antibody co-developed by Regeneron and Sanofi [NYSE:SNY], designed for the treatment of adult patients with moderate-to-severe asthma, who are uncontrolled despite treatment with inhaled corticosteroids and long-acting beta agonists (ICS/LABA).

Leerink Swann analyst Joseph Schwartz said a win here would be big for Regeneron and huge for Sanofi as the projected peak annual sales for dupilumab is $2.8 billion for two indications — asthma and atopic dermatitis indications. 

According to FierceBiotech, the analyst believes that the drug could also hit the mark for Chronic obstructive pulmonary disease (COPD), a group of lung diseases including emphysema and chronic bronchitis, that block airflow and make breathing difficult. Nearly 27 million people in the U.S. are affected by COPD.

Additional antibody pipelines with Sanofi include Fasinumab (REGN475), a fully human monoclonal antibody against nerve growth factor for the treatment of pain, REGN2222, REGN2176-3, REGN2810, REGN1500, and REGN1033.

From our technical viewpoint, REGN broke out of the ascending triangle in July 2014 with the projected price of $432 per share, determined by adding the width at the top of the pattern to the point of breakout. The stock hit the projected price of $432 per share in December 2014 and since then moved in a rising wedge pattern.

REGN broke out of the rising wedge pattern as the company announced the results of the pivotal Phase 2b study of dupilumab. The projected price for the rising wedge breakout is $598 per share. REGN ran up to the trendline resistance at around the $540 per share level in anticipation of the nod from the FDA advisory panel on Praluent. There is support at the $500 level if the stock continues to pull back.

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]. 

The 12-month target price for REGN on Yahoo Finance is $506.95 per share. Regeneron will report its second quarter 2015 earnings on August 3-7. Analysts are expecting earnings of $2.75 per share, up 11.30%, on revenue of $886.26 million, up 33.10%.

Disclosure: Long Position REGN in Portfolio. No positions in any other companies or indices mentioned.