BIOPHARMA

Regeneron Shares Break Out on Positive Pivotal Phase 2b Dupilumab Data in Asthma

Witawat (Ed) Wijaranakula, Ph.D.
Thu May 21, 2015

Shares of Regeneron Pharmaceuticals [NASDAQ:REGN] surged 2.32% to an intra-day high of $500.36 per share on Monday, May 18, after the company 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 at $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. 

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 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 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 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. There is a trendline resistance at around the $540 per share level. 

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 $503.52 per share. Regeneron will report its second quarter 2015 earnings on August 3-7. Analysts are expecting earnings of $2.75 per share, up 11.3%, on revenue of $885.88 billion, up 33.10%.

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

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