Regeneron Reports Third Quarter 2011 Financial and Operating Results
Clinical Programs Update
EYLEA™ (aflibercept injection) — Ophthalmologic Diseases
EYLEA™, also known as VEGF Trap-Eye, is a fusion protein locally administered in the eye that is designed to bind Vascular Endothelial Growth Factor-A (VEGF-A) and Placental Growth Factor (PlGF), proteins that are involved in the abnormal growth of new blood vessels. Regeneron maintains exclusive rights to EYLEA™ in
EYLEA™ is also in two Phase 3 clinical studies for the treatment of central retinal vein occlusion (CRVO), another cause of visual impairment. As previously disclosed, based on positive six-month results in these two studies, Regeneron intends to submit an additional regulatory application for marketing approval for EYLEA™ in CRVO in the U.S. by the end of 2011, and
Earlier this year,
ZALTRAP® (aflibercept) — Oncology
ZALTRAP®, also known as VEGF Trap, is a fusion protein that is designed to bind VEGF-A, VEGF-B, and PlGF, proteins that are involved in the abnormal growth of new blood vessels in solid tumors. ZALTRAP® is being developed worldwide by Regeneron and its collaborator,
Based upon positive results from the Phase 3 VELOUR trial in patients with previously treated metastatic colorectal cancer (mCRC), Regeneron and Sanofi plan to submit regulatory applications for marketing approval of ZALTRAP® to the
In addition, a randomized Phase 2 study (AFFIRM) is evaluating ZALTRAP® as a first-line treatment for mCRC in combination with FOLFOX (folinic acid [leucovorin], 5-fluorouracil, and oxaliplatin). The AFFIRM study is fully enrolled, and initial data are anticipated by the end of 2011.
ARCALYST® (rilonacept) — Gout
ARCALYST® is a fusion protein that blocks the cytokine interleukin-1 (IL-1). ARCALYST® is currently available for prescription in the U.S. for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. CAPS is a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue.
In 2010 and 2011, Regeneron reported positive Phase 3 results for ARCALYST® in the prevention of gout flares in patients initiating uric acid-lowering therapy. Based on these results, Regeneron submitted a supplemental BLA filing to the
Since 2007, Regeneron and Sanofi have collaborated on the discovery, development, and commercialization of fully human monoclonal antibodies generated by Regeneron using its VelocImmune® technology.
The following eight antibody candidates are currently in clinical development, seven under the collaboration with Sanofi:
Sarilumab (REGN88), an antibody to the interleukin-6 receptor (IL-6R), is in the Phase 3 stage of a Phase 2/3 study (MOBILITY) in rheumatoid arthritis (RA). As previously reported, in
REGN727, an antibody to Proprotein Convertase Substilisin/Kexin type 9 (PCSK9), a novel target for LDL cholesterol ("bad cholesterol") reduction, is in Phase 2 studies. In Phase 1 safety studies, using both intravenous (IV) and subcutaneous (SC) routes of administration as a single agent and in combination with statin therapy, single doses of REGN727 resulted in dose-dependent reductions in LDL cholesterol of approximately 40-60% from baseline. In these Phase 1 safety studies, injection site reactions were the most common adverse event. Three Phase 2 studies with subcutaneous regimens of REGN727 are underway: (1) a randomized, double-blind, multi-dose, placebo controlled, 75-patient trial in patients with heterozygous familial hypercholesterolemia (heFH), (2) a randomized, double-blind, multi-dose, placebo controlled, 90-patient trial in combination with atorvastatin in patients with primary hypercholesterolemia, and (3) a randomized, double-blind, multi-dose, placebo controlled, 180-patient trial in combination with atorvastatin in patients with primary hypercholesterolemia and on stable doses of atorvastatin. The primary endpoint of each Phase 2 study is the change in LDL cholesterol from baseline compared to placebo over the study period. Initial data from the Phase 2 studies are expected by the end of the year and in the first half of 2012. Regeneron and Sanofi are finalizing plans for initiating a Phase 3 program for REGN727.
REGN668, an antibody to the interleukin-4 receptor (IL-4R), a target for allergic and immune conditions, is in a Phase 1b study in patients with atopic dermatitis and a Phase 2 study in eosinophilic asthma.
REGN421, an antibody to Delta-like ligand-4 (Dll4), a novel angiogenesis target, is in a Phase 1 study in patients with advanced malignancies.
REGN910, an antibody to angiopoietin-2 (ANG2), a novel angiogenesis target, is in a Phase 1 study in patients with advanced malignancies.
REGN475, an antibody to nerve growth factor (NGF), has completed a Phase 2 trial in osteoarthritis of the knee. In
REGN728, whose target remains undisclosed, is in a Phase 1 study.
REGN846, whose target remains undisclosed, is being evaluated in a Phase 2a study in patients with atopic dermatitis. In
The Company's total revenues decreased to
Net product sales of ARCALYST® (rilonacept) in the third quarter of 2011 were
The Company's total operating expenses increased to
The Company had a net loss of
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, manufacturers, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, which is approved for the treatment of a rare inflammatory condition, Regeneron has completed Phase 3 clinical trials of rilonacept for a new indication and of product candidates EYLEA™ (aflibercept injection; VEGF Trap-Eye) in diseases of the eye, and ZALTRAP® (aflibercept; VEGF Trap) in colorectal cancer. EYLEA™ is currently under review with U.S. and European regulatory authorities. Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis, pain, cholesterol reduction, allergic and immune conditions, and cancer. Additional information about Regeneron and recent news releases are available on www.regeneron.com.
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future financial performance of Regeneron, and actual events or results may differ materially from these forward-looking statements. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's product candidates and research and clinical programs now underway or planned, the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize its product and drug candidates, competing drugs that may be superior to Regeneron's product and drug
candidates, uncertainty of market acceptance of Regeneron's product and drug candidates, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
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For the nine months
ended September 30,
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CONDENSED BALANCE SHEETS (Unaudited)
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LIABILITIES AND STOCKHOLDERS' EQUITY
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