Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — J.P. Morgan Healthcare Conference 2014
47 slides from Regeneron Pharmaceuticals's conference presentation, Jan 14, 2014
Slide 1: J.P. Morgan Healthcare Conference January 2014
J.P. Morgan Healthcare Conference January 2014 Leonard S. Schleifer, M.D., Ph.D. Chief Executive Officer Exhibit 99.1
Slide 2: Safe Harbor Statement
Safe Harbor Statement | Copyright Regeneron 2014 This presentation includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ
Slide 3: Regeneron Today: Products
Page 3 | Copyright Regeneron 2014 Regeneron Today Products *EYLEA ex-U.S is partnered with Bayer HealthCare. ZALTRAP is partnered with Sanofi Three approved products with sales in 50+ countries around the world*
Slide 4: Regeneron Today: Pipeline
Pipeline Regeneron Today Page 4 | Copyright Regeneron 2014 Phase 1 Phase 2 Phase 3 Alirocumab (REGN727) PSCK9 Antibody for LDL cholesterol reduction Sarilumab (REGN88) IL-6R Antibody for Rheumatoid arthritis Dupilumab (REGN668) IL-4R Antibody for asthma, atopic dermatitis, nasal polyposis Sarilumab
Slide 5: Regeneron Today: Profits
Regeneron Today Page 5 | Copyright Regeneron 2014 Profits Non-GAAP net income excludes non-cash share-based compensation expense, non-cash interest and non-cash income tax expense See page 38 for GAAP to non-GAAP reconciliation 1Q12 2Q12 3Q12 4Q12 1Q13 2Q13 3Q13 Products $65M in approval milestones
Slide 6: Regeneron Today: Awards
Awards Regeneron Today Page 6 | Copyright Regeneron 2014 Products Regeneron named top employer in global biopharmaceutical industry by Science Magazine for second year in a row Named the best place to work by The Scientist in 2013 CEO and CSO named "Management Team of the Year" by Scrip Intelligence
Slide 7: Regeneron Today: People
Page 7 | Copyright Regeneron 2014 People Regeneron Today Products Pipeline Profits Awards Regeneron named top employer in global biopharmaceutical industry by Science Magazine for second year in a row Number of employees grew by 20 percent in 2013 to 2,340 In four locations: Tarrytown, NY; Basking R
Slide 8: Building on Success
Regeneron Building on Success Page 8 | Copyright Regeneron 2014 Organic Growth Continuing Top Line Growth Investment in R&D and Technology
Slide 9: What's New for Regeneron: Significant News January 2014
Regeneron Building on Success EYLEA ® & Ophthalmology Franchise Alirocumab Sarilumab Dupilumab Sanofi Collaboration Early R&D 2014 Financial Guidance Page 9 | Copyright Regeneron 2014 Significant News January 2014 What’s New for Regeneron 4Q13 and full year 2013 U.S. net sales PDGFR- clinical and bu
Slide 10: Building on Success: Continuing Top Line Growth
Regeneron Building on Success Page 10 | Copyright Regeneron 2014 Continuing Top Line Growth
Slide 11: Building on Success: EYLEA Franchise
Regeneron Building on Success EYLEA Franchise Page 11 | Copyright Regeneron 2014 Potential for five major regulatory submissions or approvals in next five years
Slide 12: EYLEA Franchise
Page 12 | Copyright Regeneron 2014 EYLEA Franchise
Slide 13: Optimize and Extend EYLEA
Regeneron Optimize and Extend EYLEA Page 13 | Copyright Regeneron 2014 2013 U.S. Net Sales : ~$1.4 Billion* 4Q13 U.S. Net Sales : ~$400 Million* Distributor inventory increased to slightly more than two weeks Inventory has historically been 1-2 weeks Commercial terms tightened in January 2014 Full y
Slide 14: EYLEA Ex-U.S. Net Sales
Q\EYLEA (aflibercept) injection lst Ex-U.S. Net Sales $125 $MM 4Q12 1Q13 2Q13 3Q13
Slide 15: Ex-U.S. Net Sales
Ex-U.S. Net Sales 1Q13 2Q13 $125 3Q13
Slide 16: Ex-U.S. EYLEA: Launch is Still in Early Innings
Regeneron Optimize and Extend EYLEA Ex-U.S. EYLEA: Launch is Still in Early Innings Ex-U.S. sales contributing to bottom line DME submitted in EU Myopic CNV filed in Japan Global macular edema following BRVO submission expected in 2014 DME : Diabetic Macular Edema AMD: Age-related macular degenerati
Slide 17: Protecting the Long Term Value of the Retina Franchise
Regeneron Optimize and Extend EYLEA PDGFR- /EYLEA ® co-formulation IND submitted in December 2013 First patient enrolled in Phase 1 expected in 1Q14 Regeneron owns 100% commercial rights in U.S. Bayer collaborating outside the U.S. Page 15 | Copyright Regeneron 2014 Protecting the Long Term Value of
Slide 18: Late Stage Pipeline
Page 16 | Copyright Regeneron 2014 Late Stage Pipeline
Slide 19: Late Stage Pipeline Expected to Drive Continued Top-Line Growth
Regeneron Advance Late Stage Pipeline PHASE 3 PHASE 3 PHASE 2 Three Late Stage Programs Page 17 | Copyright Regeneron 2014 Late Stage Pipeline Expected to Drive Continued Top-Line Growth PCSK9 antibody for elevated cholesterol IL6R antibody for rheumatoid arthritis IL4R antibody for asthma, atopic d
Slide 20: Alirocumab: Advancing Late Stage Opportunities
Regeneron Alirocumab Positive data from the alirocumab clinical trials have been published in peer-reviewed journals such as the New England Journal of Medicine and The Lancet | Copyright Regeneron 2014 Advancing Late Stage Opportunities
Slide 21: Sarilumab for Rheumatoid Arthritis
Regeneron Sarilumab Page 19 | Copyright Regeneron 2014 Advancing Late Stage Opportunities Positive Phase 3 data from MOBILITY (N=1,200) reported 4Q13 Both sarilumab dose groups—150 mg and 200 mg—given subcutaneously, every other week, in combination with methotrexate (MTX) achieved all three co-prim
Slide 22: Dupilumab: Advancing Late Stage Opportunities
Regeneron Dupilumab Positive data from the dupilumab asthma clinical trial have been published in the New England Journal of Medicine | Copyright Regeneron 201 4 Advancing Late Stage Opportunities
Slide 23: Building on Success: Investment in R&D and Technology
Regeneron Building on Success Page 21 | Copyright Regeneron 2014 Investment in R&D and Technology
Slide 24: Wholly-Owned Pipeline of Products
Regeneron Building on Success Page 22 | Copyright Regeneron 2014 Wholly-Owned Pipeline of Products Sanofi Collaboration Fasinumab* Phase 2 REGN1400 Phase 1 REGN1154 Phase 1 REGN1500 Phase 1 REGN1193 Phase 1 REGN1908-1909 Phase 1 Innovative Research & Technologies Investment in R&D and Technology
Slide 25: Sanofi Collaboration
Page 23 | Copyright Regeneron 2014 Sanofi Collaboration
Slide 26: Sanofi Antibody Collaboration Continues to Provide R&D Leverage
Regeneron Sanofi Collaboration Ownership / Investor Agreement • Sanofi ownership is currently 15.8M shares or ~16% • Sanofi has obtained right to nominate an independent director to Regeneron BOD when they reach 20% ownership • Voting rights, lock-up, and standstill limit to 30% ownership Sanofi Col
Slide 27: Sanofi Collaboration Pipeline and R&D Funding
Phase 1 Phase 2 Phase 3 Alirocumab (REGN727) PSCK9 Antibody for LDL cholesterol reduction Sarilumab (REGN88) IL-6R Antibody for Rheumatoid arthritis Dupilumab (REGN668) IL-4R Antibody for Asthma, Atopic dermatitis, nasal polyposis Sarilumab (REGN88) IL-6R Antibody for Non-infectious Uveitis REGN1033
Slide 28: Pipeline of Wholly-Owned Antibodies
Page 26 | Copyright Regeneron 2014 Pipeline of Wholly-Owned Antibodies
Slide 29: Pipeline of Wholly-Owned Antibodies is Growing
Regeneron Wholly-Owned Antibody Pipeline Wholly-Owned Clinical Stage Antibodies Advancing early stage pipeline of Regeneron-owned antibodies Fasinumab* (Phase 2, NGF antibody) REGN1400 (Phase 1, ErbB3, advanced malignancies) REGN1154 (Phase 1, undisclosed target) REGN1500 (Phase 1, undisclosed targe
Slide 30: Innovative Research and Novel Technologies
Page 28 | Copyright Regeneron 2014 Innovative Research and Novel Technologies
Slide 31: Innovating for the Future
Regeneron Innovating for the Future Immuno-Oncology CD20-CD3 bispecific antibody expected to enter clinic in 2014 Page 29 | Copyright Regeneron 2014 Investment in Research & Development and Technology Regeneron Genetics Center Major new investment in human genetics research Collaboration with Geisin
Slide 32: Human IgG
Human IgG* Human IgG
Slide 33: Human IgG
Human IgG* Human IgG
Slide 34: Immuno-Oncology Approach: CD20-CD3 Bispecific Antibody
Regeneron Innovating for the Future T-cell Tumor Cell Immuno-Oncology Approach: CD20-CD3 Bispecific Antibody Bispecific antibody bind T Cells (via CD3) and tumor (via specific surface marker) Use of modified VelocImmune ® mice to generate fully human bispecific antibodies provides benefits High affi
Slide 35: VelociGene and Geisinger
WVELOCIGENE GEISINGER
Slide 36: Geisinger and VelociGene
GEISINGER WVELOCIGENE
Slide 37: Regeneron Genetics Center a Major Initiative in Human Genetics
Regeneron Innovating for the Future Targets & Indications | Copyright Regeneron 2014 Regeneron Genetics Center a Major Initiative in Human Genetics Regeneron Genetics Center Population-Based Family-Based Collaborations: Geisinger, NIH, and pursuing more Approaches: population and family based, conso
Slide 38: Building on Success: Organic Growth
Organic Growth Regeneron Building on Success Page 32 | Copyright Regeneron 2014
Slide 39: Growth in Manufacturing and at Corporate Headquarters
Regeneron Organic Growth Page 33 | Copyright Regeneron 2014 Growth in Manufacturing and at Corporate Headquarters Two new buildings to support additional research and development Expansion in Tarrytown, NY Expect to increase headcount to >4,000 by 2018 People Expansion in Rensselaer, NY and new faci
Slide 40: 2014 Financial Guidance
Regeneron Financial Guidance Page 34 | Copyright Regeneron 2014 Financial Guidance Non-GAAP SG&A: $330MM - $380MM Increase in prelaunch commercial expenses, contribution to patient assistance programs, pharma fee and headcount Non-GAAP Unreimbursed R&D: $425MM - $475MM ~$115 M in expenses related to
Slide 41: Building on Success
Continuing Top Line Growth Organic Growth Regeneron Building on Success Page 35 | Copyright Regeneron 2014 Investment in R&D and Technology
Slide 42: 2014 Milestones
Regeneron 2014 Milestones Page 36 | Copyright Regeneron 2014 Upcoming Milestones Clinical Phase 2 data for dupilumab in atopic dermatitis in 1H14 Phase 3 trial to start with dupilumab in AD in 2014 Phase 3 data from alirocumab ODYSSEY program in mid-2014 through 3Q14 PDGFR /EYLEA coformulation to en
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Slide 44: Slide 44
Slide 45: Significant News Flow at J.P. Morgan
Regeneron News EYLEA Alirocumab Dupilumab Sanofi Human Genetics Immuno-Oncology 2014 Financial Guidance PDGFR- Page 37 | Copyright Regeneron 2014 Significant News Flow at J.P. Morgan What’s News for Regeneron at J.P. Morgan 2014 Full year 2013 U.S. Net Sales: ~$1.4 # Billion 4Q13 U.S. Net Sales: ~$4
Slide 46: GAAP to Non-GAAP Reconciliation
GAAP to Non-GAAP Reconciliation 1Q’12 2Q’12 3Q’12 4Q’12 1Q’13 2Q’13 3Q’13 GAAP net income 11,651 76,743 191,468 470,407 98,874 87,376 141,306 Adjustments R&D: Non-cash share-based compensation expense 10,556 11,442 13,337 18,498 26,761 27,722 28,258 SG&A: Non-cash share-based compensation expense 12
Slide 47: Thank you!
REGENERON science to medicine® Thank you!
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