Nov. 3, 2009 (PR Newswire) --
TARRYTOWN, N.Y., Nov. 3 /PRNewswire-FirstCall/ -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced financial and operating results for the third quarter of 2009. The Company reported a net loss of $1.0 million, or $0.01 per share (basic and diluted), for the third quarter of 2009 compared with a net loss of $19.1 million, or $0.24 per share (basic and diluted), for the third quarter of 2008. The Company reported a net loss of $31.3 million, or $0.39 per share (basic and diluted), for the nine months ended September 30, 2009 compared with a net loss of $49.6 million, or $0.63 per share (basic and diluted), for the same period in 2008. During the third quarter of 2009, the Company recognized as revenue a $20.0 million milestone payment from Bayer HealthCare, as described below.
At September 30, 2009, cash, restricted cash, and marketable securities totaled $438.6 million compared with $527.5 million at December 31, 2008.
Current Business Highlights
ARCALYST® (rilonacept) - Inflammatory Diseases
The Company shipped $5.3 million of ARCALYST® (rilonacept) Injection for Subcutaneous Use to its U.S. distributors during the third quarter of 2009, compared to $4.3 million in the same quarter of 2008. Shipments during the first nine months of 2009 were $15.0 million compared to $6.7 million for the same period of 2008. ARCALYST, an interleukin-1 (IL-1) blocker, was approved in the United States in February 2008 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. The Company currently projects shipments of ARCALYST to its U.S. distributors to total approximately $20 million in 2009. In October 2009, rilonacept was approved under exceptional circumstances by the European Medicines Agency (EMEA) for the treatment of CAPS with severe symptoms in adults and children aged 12 years and older.
ARCALYST is in a Phase 3 clinical development program for the treatment of gout. The program includes four clinical trials, all of which are currently enrolling patients. Two Phase 3 clinical trials (called PRE-SURGE 1 and PRE-SURGE 2) are evaluating ARCALYST versus placebo for the prevention of gout flares in patients initiating urate-lowering drug therapy. A third Phase 3 trial in acute gout (SURGE) is evaluating treatment with ARCALYST alone versus ARCALYST in combination with a non-steroidal anti-inflammatory drug (NSAID) versus an NSAID alone. The fourth Phase 3 trial is a placebo-controlled safety study (RE-SURGE). The Company expects to report initial data from the Phase 3 program in the first half of 2010. Regeneron owns worldwide rights to ARCALYST (rilonacept).
Aflibercept (VEGF Trap) - Oncology
Aflibercept, an anti-angiogenic protein product candidate designed to bind all forms of vascular endothelial growth factor A (VEGF-A), is being developed worldwide by Regeneron and its collaborator, sanofi-aventis. At the end of the third quarter of 2009, more than 80 percent of the planned number of patients were enrolled in each of three Phase 3 trials that are evaluating combinations of aflibercept with standard chemotherapy regimens for the treatment of cancer. One trial (called VELOUR) is evaluating aflibercept as a 2nd line treatment for metastatic colorectal cancer in combination with FOLFIRI (folinic acid (leucovorin), 5-fluorouracil, and irinotecan). A second trial (VITAL) is evaluating aflibercept as a 2nd line treatment for metastatic non-small cell lung cancer in combination with docetaxel. The third trial (VENICE) is evaluating aflibercept as a 1st line treatment for metastatic androgen-independent prostate cancer in combination with docetaxel/prednisone. All three trials are studying the current standard of chemotherapy care for the cancer being studied with and without aflibercept. Analyses of the data from these studies will be conducted when a prespecified number of events have occurred in each trial. Based on current enrollment and event rates, an interim analysis of the Phase 3 study in colorectal cancer is expected to be conducted by an independent data monitoring committee (IDMC) in the second half of 2010. Complete results from this study in colorectal cancer and from the study in non-small cell lung cancer are anticipated in the first half of 2011. Based on the current enrollment and number of events, an interim analysis of the prostate study is expected to be conducted by an IDMC in mid-2011, with complete results anticipated in 2012. In addition, a Phase 2 study (AFFIRM) is being conducted of aflibercept in 1st line metastatic colorectal cancer in combination with folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin.
In September 2009, as previously reported, a fourth Phase 3 trial (VANILLA) that was evaluating aflibercept as a 1st line treatment for metastatic pancreatic cancer in combination with gemcitabine was discontinued at the recommendation of an IDMC. As part of a planned interim efficacy analysis, the Committee determined that the addition of aflibercept to gemcitabine would be unable to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to placebo plus gemcitabine in this study. The types and frequencies of adverse events reported on the combination arm with aflibercept were generally as anticipated.
VEGF Trap-Eye - Ophthalmologic Diseases
VEGF Trap-Eye, a specially purified and formulated form of VEGF Trap for use in intraocular treatment of retinal disease, is being developed by Regeneron and its collaborator, Bayer HealthCare. Two Phase 3 studies (VIEW 1 and VIEW 2) evaluating VEGF Trap-Eye in patients with the neovascular form of Age-related Macular Degeneration (wet AMD) are now fully enrolled, and we expect initial data from this program to be reported in late 2010. A Phase 2 study (called DA VINCI) of VEGF Trap-Eye for the treatment of the Diabetic Macular Edema (DME) is also fully enrolled, with data expected during the first half of 2010. Additionally, two Phase 3 studies in Central Retinal Vein Occlusion (CRVO) are enrolling patients; data from the first of these studies are anticipated to be available in the first half of 2011.
During October 2009, 24-month results of the extension stage of the Phase 2 study of VEGF Trap-Eye in wet AMD (CLEAR-IT 2) were presented at the 2009 American Academy of Ophthalmology meeting. After receiving VEGF Trap-Eye for one year, the 117 patients who elected to enter the extension stage were dosed on a 2.0 mg PRN basis, irrespective of the dose at which they were treated earlier in the study. On a combined basis, for these 117 patients, the mean gain in visual acuity was 7.3 letters (p<0.0001>p<0.0001>p<0.0001>
Bayer HealthCare has rights to market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.
Monoclonal Antibodies
During the third quarter of 2009, REGN475, an antibody to Nerve Growth Factor (NGF), a novel target for pain, began a dose ranging study in osteoarthritis of the knee. Trial results are expected during the first half of 2010. A Phase 1 study of REGN475 in healthy volunteers is also continuing, and Phase 1 studies are in progress with REGN88, an antibody to the interleukin-6 receptor (IL-6R) that is being evaluated in rheumatoid arthritis, and REGN421, an antibody to Delta-like ligand-4 (Dll4) that is being studied in patients with advanced malignancies. REGN475, REGN88, and REGN421 are fully human monoclonal antibodies generated by Regeneron using the VelocImmune® technology and developed within the Company's human antibody collaboration with sanofi-aventis. Regeneron and sanofi-aventis expect to enter two more human monoclonal antibodies into clinical development this year and to advance an average of two to three into clinical development each year thereafter over the next several years.
Financial Results
Revenues
Total revenues increased to $117.5 million in the third quarter of 2009 from $65.6 million in the same quarter of 2008 and increased to $282.5 million for the first nine months of 2009 from $182.6 million for the same period of 2008. The Company's revenue was comprised of contract research and development revenue, a 2009 research progress payment, technology licensing revenue, and net product sales.
