![]() J.P. Morgan Healthcare Conference January 2013 Exhibit 99.1 |
![]() 2 SAFE HARBOR STATEMENT Except for historical information, the matters contained in this presentation may constitute forward-looking statements that involve risks and uncertainties, including risks and uncertainties related to product development and clinical trials, unforeseen safety issues resulting from the administration of products and product candidates in patients, uncertainties related to the need for regulatory and other government approvals, government regulations, risks related to third party patents and proprietary technology, litigation, the need for additional capital, uncertainty of market acceptance of Regeneron’s products and product candidates, the ability of the Company to meet any of its sales or other financial projections, the receipt of future payments, the continuation of business partnerships, and additional risks detailed from time to time in Regeneron’s filings with the Securities and Exchange Commission (SEC). Please refer to Regeneron’s Form 10-K for the year ended December 31, 2011 and its Form 10-Q for the quarter ended September 30, 2012 for additional information on these risks and uncertainties and for other information related to our business. Because forward-looking statements involve risks and uncertainties, actual results may differ materially from current results expected by Regeneron. Regeneron is providing this information as of the original date of this presentation and expressly disclaims any duty to update any information contained in these materials, including without limitation any sales forecasts and any other forward-looking statements. |
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![]() 4 REGENERON TRANSFORMED One of the top 5 biopharmaceutical launches of all time EYLEA ® LAUNCH HAS EXCEEDED EXPECTATIONS EYLEA US, EU, Japan, Australia, and other countries; ZALTRAP US MULTIPLE REGULATORY APPROVALS GAAP & Non-GAAP FOUR FULL QUARTERS OF PROFITABILITY Year end cash and receivables of ~$1.2B STRONG FINANCIAL POSITION Science magazine annual poll; “Biotechnology Company of the Year” by Scrip Intelligence WORLD’S #1 BIOPHARMACEUTICAL EMPLOYER |
![]() 5 REGENERON LOOKING FORWARD RESEARCH & DEVELOPMENT Expanding late stage pipeline with REGN727 (PCSK9), Sarilumab (IL6R), & REGN668 (IL4R) Continuing to invest in early stage pipeline and innovative technologies EYLEA Increasing market share, expanding geographies and indications, securing future ZALTRAP Global launch; Novel combinations FINANCIAL Continuing growth in sales and profits |
![]() 6 EYLEA net product sales of $276 million in 4Q12* $838 million in full year 2012* 2013 EYLEA U.S. net sales guidance: ~50% growth (i.e. ~$1.2B to $1.3B) U.S. LAUNCH * 4Q12 Sales Estimate EXCEEDING EXPECTATIONS |
![]() 7 * 4Q12 Sales Estimate EXPANDING BRANDED MARKET 0 100 200 300 400 500 600 700 3Q11 4Q11 1Q12 2Q12 3Q12 4Q12 EYLEA Lucentis EYLEA & Lucentis Total +47 % |
![]() 8 EXPANDING GEOGRAPHY 3Q11 4Q11 1Q12 2Q12 3Q12 0 100 200 300 400 500 600 700 US: EYLEA US: Lucentis exUS: Lucentis |
![]() 9 Trials fully enrolled Diabetic Macular Edema (DME) BROADENING INDICATIONS Myopic CNV Trial fully enrolled in Asia Trial enrolling Branch Retinal Vein Occlusion (BRVO) Approved in U.S.; Filings globally Central Retinal Vein Occlusion (CRVO) |
![]() 10 SECURING THE FUTURE High affinity, fully-human antibody to PDGFR Goal to enter clinic with co-formulated product in 2H13 PDGFR High affinity, fully human antibody to ang2 Goal to enter into ophthalmology clinical development in 2013 ANG2 Novel formulation and delivery of EYLEA as well as evaluation of new technologies Novel Targets in Development for Retinal Disease |
![]() 11 OPPORTUNITIES IN CANCER Approved and launched in U.S. Discovered by Regeneron and co-developed with Sanofi Regeneron has worldwide co-commercialization rights Approved in the US Positive recommendation for approval by European CHMP EU approval expected 1Q13 Regeneron has worldwide co-commercialization rights Pending Approval in the EU ZALTRAP is the only agent that has demonstrated a statistically significant improvement in overall survival in combination with FOLFIRI versus FOLFIRI alone in patients who progressed on a prior oxaliplatin-containing regimen. |
![]() 12 EXPANDING LATE STAGE PIPELINE IL6R antibody for rheumatoid arthritis Sarilumab PCSK9 antibody for elevated cholesterol REGN727 IL4R antibody for Asthma and Atopic Dermatitis REGN668 |
![]() 13 (1) Tibolla G et al. Nutr Metab Cardiovasc Dis 2011;21:835-43. (2) Akram ON et al. Arterioscler Thromb Vasc Biol 2010;30:1279-81. (3) Duff CJ et al. Expert Opin Ther Targets 2011;15:157-68. (4) Horton JD et al. J Lipid Res 2009;50 Suppl:S172-7. (5) Cariou B et al. Atherosclerosis 2011;216:258-65. PCSK9: BLOCKING PCSK9 CAN POTENTIALLY LOWER LDL-C LEVELS 1-5 |
![]() 14 Phase 2 data published in The Lancet, Journal of the American College of Cardiology, and NEJM Significantly reduced mean LDL-C by 40% to 72% over 8 to 12 weeks in patients on stable dose of statins Most common adverse event was injection site reaction Mean percentage change in calculated LDL-C from baseline to weeks 2, 4, 6, 8, 10, and 12 in the modified intent-to-treat (mITT) population, by treatment group. Week 12 estimation using LOCF method. *Data from Phase 2 , dose-ranging study. Patients were on background atorvastatin therapy of 10, 20, or 40 mg. Decrease in LDL-C shown is at week 12. REGN727: LDL CHOLESTEROL REDUCTION Change in Calculated LDL-C at Bi-Weekly Intervals from Baseline to Week 12 in Patients With Primary Hypercholesterolemia. |
![]() 15 FH I HIGH FH FH II OPTIONS I OPTIONS II MONO ALTERNATIVE LONG TERM COMBO I COMBO II N=105 18 months N=471 18 months N=250 18 months N=2,100 18 months N=306 12 months N=660 24 months N=250 6 months N=300 6 months N=100 6 months N=350 6 months N=18,000 (Event Driven) REGN727: LDL CHOLESTEROL REDUCTION OUTCOMES Heterozygous Familial Hypercholesterolemia High Cholesterol at High Cardiovascular Risk Additional populations/studies |
![]() SARILUMAB: RHEUMATOID ARTHRITIS Sarilumab is a fully human, high affinity, interleukin-6 receptor (IL-6R) antibody Positive Phase 2 study in rheumatoid arthritis Types and incidence of adverse events consistent with those previously reported with IL-6 inhibition Phase 3 MOBILITY trial fully enrolled Phase 3 TARGET trial enrolling 16 *p<0.01 versus placebo (only unadjusted p-values <0.01 are considered statistically significant) Significant improvements in signs and symptoms of moderate-to-severe RA in patients receiving sarilumab in combination with methotrexate in Phase 2 study. ACR20 ACR50 ACR70 46.2 66.7 65.4 15.4 35.3 40.4 1.9 11.8 17.3 0 10 20 30 40 50 60 70 80 Placebo 150 mg q2w 200mg q2w |
![]() REGN668: ASTHMA AND ATOPIC DERMATITIS 17 Positive proof of concept data for atopic dermatitis to be submitted for presentation at a medical conference in 2013 Positive proof of concept data for asthma to be submitted for presentation at a medical conference in 2013 Phase 2b initiation in both indications expected mid-year IL-4 IL-13 Dominant (some overlapping) functions in : • Initiation and drive of T H 2 differentiation • Activation and growth of B cells • Class switching to IgE and IgG1a • Recruitment of eosinophils • Airway hyper responsiveness (AHR) • Goblet cell hyperplasia • Tissue remodeling • Fibrosis • Regulation of gastrointestinal parasite expulsion |
![]() BROAD ANTIBODY PIPELINE 18 Inflammation Therapeutic Focus Legend: Metabolism Oncology Ophthalmology Pain REGN421 (DII4 Antibody) Advanced malignancies REGN910 (ANG2 Antibody) Advanced malignancies REGN1033 (GDF8 Antibody) Metabolic disorders REGN1400 (ERBB3 Antibody) Advanced malignancies REGN846 (undisclosed target) Atopic dermatitis REGN1154 (undisclosed target) REGN1500 (undisclosed target) Phase 1 REGN668 (IL-4R Antibody) Eosinophilic asthma REGN668 (IL-4R Antibody) Atopic dermatitis REGN475* (NGF Antibody) Osteoarthritis Phase 2 REGN727 (PCSK9 Antibody) LDL cholesterol reduction Sarilumab (IL-6R Antibody) Rheumatoid arthritis EYLEA Diabetic macular edema EYLEA Branch Retinal Vein Occlusion Phase 3 Novel Antibody Technologies in Preclincal Development Bispecific Antibodies Long Acting Technologies Antibody Drug Conjugates *Remains on clinical hold by the FDA |
![]() SANOFI ANTIBODY COLLABORATION 19 *100% development funding by Sanofi for all opted-in antibodies except 80% of an antibody’s Phase 3 costs incurred after receipt of the first positive results in a Phase 3 trial for that antibody. **Regeneron repays Sanofi for 50% of development costs out of profits. Repayment capped in any year at 10% of Regeneron share of total antibody profits Discovery Discovery Development Development Commercialization Commercialization $160 million of annual funding through 2017 (plus possible tail period through 2020) Sanofi funds approximately 100% of clinical development cost* Current antibodies include: • REGN727 (Phase 3) Sarilumab (Phase 3) • REGN668 (Phase 2) • 3 additional in Phase 1 Regeneron retains 50% of profits in US** Regeneron retains 35% to 45% of profits ex-US** Co-promotion rights in US and other major market countries |
![]() FINANCIALS 20 Year-end 2012 Year-end 2012 cash and cash and securities securities Year-end 2012 Year-end 2012 trade receivables receivables Non-GAAP Net Income * Unaudited Estimate $0 $50 $100 $150 $200 $250 1Q12 2Q12 3Q12 |
![]() THE YEAR AHEAD 21 • EYLEA US sales guidance of ~50% growth (i.e. $1.2B to $1.3B) • EYLEA ex-US launch in multiple additional countries COMMERCIAL MILESTONES • EYLEA approval in CRVO outside the U.S. • ZALTRAP approval in metastatic colorectal cancer outside the U.S. EXPECTED REGULATORY MILESTONES • Top-line 1-year Phase 3 EYLEA results in DME by year end • REGN668 Phase 1b data in Atopic Dermatitis to be presented at a medical conference • REGN668 Phase 2a data in Asthma to be presented at a medical conference • Sarilumab additional Phase 3 trials in RA to start • Enrollment updates for REGN727 in hypercholesterolemia EXPECTED CLINICAL MILESTONES |