Biogen Inc. · NASDAQ:BIIB
Biogen — Biogen Idec — Q1 2014 Earnings Presentation
36 slides from Biogen's earnings presentation, Apr 23, 2014
Slide 1: First Quarter 2014 Financial Results & Business Update
TITLE OF PRESENTATION FIRST QUARTER 2014 FINANCIAL RESULTS & BUSINESS UPDATE APRIL 23, 2014
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements, including statements about 2014 financial guidance, anticipated regulatory decisions and data read-outs, and potential product launches and timing thereof. These forward-looking statements may be accompanied by such wo
Slide 3: Q1 2014 Earnings Call Agenda
Q1 2014 Earnings Call Agenda INTRODUCTION: CLAUDINE PROWSE, Ph.D., VP, Investor Relations OVERVIEW: GEORGE SCANGOS, Ph.D., Chief Executive Officer R&D UPDATE: DOUG WILLIAMS, Ph.D., EVP, Research & Development COMMERCIAL UPDATE: TONY KINGSLEY, EVP, Global Commercial Operations FINANCIAL PERFORMANCE:
Slide 4: Overview
TITLE OF PRESENTATION OVERVIEW GEORGE SCANGOS, Ph.D., CHIEF EXECUTIVE OFFICER
Slide 5: Q1 2014 Financial Performance
Q1 2014 Financial Performance* Non-GAAP Diluted EPS ($)** +51% +59% 1,743 2,130 2.47 1.97 1,415 1,096 Q1-13 Q1-14 GAAP Diluted EPS ($)** 2.02 1.79 Q1-13 Q1-14 Q1-13 Q1-14 Total Revenues ($M) Product Revenues ($M) Q1-13 Q1-14 *AS OF Q2-13, REVENUE AND NET INCOME INCLUDES 100% OF GLOBAL IN-MARKET TYSA
Slide 6: Q1 2014 Highlights
Q1 2014 Highlights PRODUCT PERFORMANCE EXPANDED PIPELINE Delivered double digit top and bottom line growth Agreement with Eisai to develop and commercialize Eisai product candidates for the treatment of TECFIDERA is the #1 oral MS therapy and achieved Alzheimer‟s disease over $1B in product revenue
Slide 7: R&D Update
TITLE OF PRESENTATION R&D UPDATE DOUG WILLIAMS, Ph.D., EXECUTIVE VICE PRESIDENT, RESEARCH & DEVELOPMENT
Slide 8: ALPROLIX Approved in the US and Canada
ALPROLIX Approved in the US and Canada FDA Label Highlights Approved for the control and prevention of bleeding episodes, perioperative management and routine prophylaxis in adults and children with hemophilia B Prophylaxis starting dosing: 50 IU/kg once weekly or 100 IU/kg once every 10 days
Slide 9: ELOCTATE: Kids A-LONG Phase 3 Study Highlights
ELOCTATE: Kids A-LONG Phase 3 Study Highlights Positive Top-Line Efficacy & Safety Results Twice-weekly prophylactic dosing maintained low bleeding rates in children No inhibitors detected Relative increase in half-life in children with severe hemophilia A was consistent with the 1.5-fold increase i
Slide 10: 2014 American Academy of Neurology Annual Meeting Highlights
2014 American Academy of Neurology (AAN) Annual Meeting Highlights TECFIDERA DACLIZUMAB HYP Efficacy data, including effect on minority populations Reduction in brain atrophy based on results of and Quality of Life data SELECT and the SELECT extension study Phase 4 MANAGE real-world data demonstrate
Slide 11: BAN2401: Phase 2 for Alzheimer's Disease
BAN2401: Phase 2 for Alzheimer's Disease Lead • Alzheimer’s disease Indication Presumed Mechanism • Humanized mAb to amyloid-beta protofibril of Action Potential Mechanism of Action of Amyloid Beta Antibody Therapy for Alzheimer's Disease • Ph2b double-blind, placebo-controlled, (n~800) study using
Slide 12: E2609: Entering Phase 2 for Alzheimer's Disease
E2609: Entering Phase 2 for Alzheimer's Disease Presumed β Secretase Role in Amyloid Beta Production Lead • Alzheimer’s disease Indication • Small molecule inhibitor of β secretase, Yan, Lancet Neurology, 2014 Presumed known as β-site amyloid precursor protein Mechanism (APP) cleaving enzyme 1 (BACE
Slide 13: Daclizumab HYP: Potential 1x Monthly Subcutaneous Therapy for RMS
Daclizumab HYP: Potential 1x Monthly Subcutaneous Therapy for RMS Monoclonal antibody targeting alpha SELECT (Phase 2b study) 1 year data subunit of IL-2 receptor demonstrated: Robust reduction in relapse rate and disability progression SAEs included infections, cutaneous events and hepatic even
Slide 14: Deep Pipeline: In a Data-Rich Period
Deep Pipeline: In a Data-Rich Period PHASE I PHASE II PHASE III FILED ALPROLIX* Hemophilia B FDA APPROVED Late-Stage ELOCTATE* Hemophilia A FDA FILED PLEGRIDY Multiple Sclerosis FDA & EU FILED DACLIZUMAB HYP* Multiple Sclerosis TYSABRI Secondary Progressive Multiple Sclerosis GAZYVA* Diffuse Large B
Slide 15: Commercial Update
TITLE OF PRESENTATION COMMERCIAL UPDATE TONY KINGSLEY, EXECUTIVE VICE PRESIDENT, GLOBAL COMMERCIAL OPERATIONS
Slide 16: Global MS Franchise Performance
Global MS Franchise Performance MS Franchise Sales ($M) +41% 1,727 1,593 1,438 1,370 506 398 1,225 192 286 456 387 427 441 401 746 774 733 751 761 23 17 17 17 19 Q1-13 Q2-13 Q3-13 Q4-13 Q1-14 FAMPYRA AVONEX TYSABRI* TECFIDERA * Prior to Q2‟13 TYSABRI sales do not include the impact of hedging. TYSAB
Slide 17: Strong TECFIDERA Launch
Strong TECFIDERA Launch TECFIDERA Revenue ($M) 506 Q1 2014 Highlights 46 Revenue vs. Q4 2013 398 WW + 27% 7 US + 18% ROW NMF 286 TECFIDERA’s rapid launch trajectory continued 2 #1 prescribed oral MS drug in US according to 460 192 IMS 390 2 284 Approximately 7,000 physicians have prescribed TECFIDER
Slide 18: Global AVONEX Performance
Global AVONEX Performance AVONEX Revenues ($M) Q1 2014 Highlights Revenue vs. Q1 2013 & Q4 2013 WW +2% and +1% US -3% and 0% 774 761 ROW +12% and 3% 746 733 751 Units vs. Q1 2013 & Q4 2013 255 295 277 285 WW +1% and +3% 277 US - 16% and -2% ROW +12% and +5% AVONEX gained global market share within t
Slide 19: Global TYSABRI Performance
Global TYSABRI Performance Q1 2014 Highlights TYSABRI In-Market Sales ($M) In-Market Sales* vs. Q1 2013 and Q4 2013 456 441 427 WW -3% and +3% 401 387 US -9% and -7% ROW +4% and +18% 198 176 207 169 Units vs. Q1 2013 and Q4 2013 169 WW - 10% and +3% US - 22% and -12% ROW 0% and +16% Patient retentio
Slide 20: Hemophilia Commercial Preparations Underway
Hemophilia Commercial Preparations Underway FDA Approved: March 2014 Anticipated US Launch: Mid-2014 Anticipated US Launch: Early May US physician awareness is high Commitment to transform the care of people with hemophilia through expanded use of prophylactic treatment Access and assistance program
Slide 21: Financial Performance
TITLE OF PRESENTATION FINANCIAL PERFORMANCE PAUL CLANCY, EXECUTIVE VICE PRESIDENT, CHIEF FINANCIAL OFFICER
Slide 22: Q1 2014 GAAP to Non-GAAP Reconciliation
Q1 2014 GAAP to Non-GAAP Reconciliation Q1 2014 GAAP Diluted EPS $2.02 GAAP Net Income Attributable to Biogen Idec Inc. ($M) 480.0 Amortization of Intangibles $139.8 Contingent Consideration (0.8) Stock Option Expense 4.9 Tax Impact (37.0) Total Adjustments $106.9 Non-GAAP Net Income Attributable to
Slide 23: Q1 2014 Financial Results Summary: Revenues
Q1 2014 Financial Results Summary: Revenues $ in Millions Q1 Q4 Q1 %D %D 2013 2013 2014 Q/Q Y/Y AVONEX US $491 $475 $476 0% (3%) AVONEX ROW $255 $277 $285 3% 12% Total AVONEX Sales1 $746 $751 $761 1% 2% TYSABRI US $113 $251 $234 (7%) 107% TYSABRI ROW $199 $176 $207 18% 4% TYSABRI Rev to BIIB1,4 $312
Slide 24: RITUXAN & GAZYVA Performance
RITUXAN & GAZYVA Performance RITUXAN & GAZYVA Results ($M) 947 Q1 2014 Highlights 865 95^ 876 811 Revenue vs. Q1 2013 and Q4 2013 806 852 US Net Sales 1% and 9% US Profit Share* -3% and 9% ROW Royalty NMF and 33% BIIB Revenue 12% and 10% 289 303 297 282 269 265 282 275 271 253 (17) 18 21 17 22 Ongoi
Slide 25: Q1 2014 Financial Results Summary
Q1 2014 Financial Results Summary $ in Millions %D %D Q1 2013 Q4 2013 Q1 2014 Q/Q Y/Y Cost of Sales1 $134 $259 $279 (8%) (109)% % of Total Revenues 9% 13% 13% Non-GAAP R&D $283 $421 $527 (25%) (86%) Expenses2 % of Total Revenues 20% 21% 25% Non-GAAP SG&A $351 $495 $509 (3%) (45%) Expenses3 % of Tota
Slide 26: Q1 2014 Financial Results Summary
Q1 2014 Financial Results Summary $ in Millions except EPS Q1 Q4 Q1 %D %D Shares in millions 2013 2013 2014 Q/Q Y/Y Other income (expense), net1 $(14) ($5) ($6) (4%) 61% Non-GAAP Tax Rate2 14% 29% 27% Equity in Loss of Investee, net of tax4 $4 $5 $8 (53%) (100%) Non-GAAP Net Income attributable to B
Slide 27: Updated 2014 Full Year Financial Guidance
Updated 2014 Full Year Financial Guidance Expense ratios apply to both GAAP and Prior FY 2014 Updated FY 2014 Non-GAAP 2014 Full Year Guidance. Guidance Guidance Approximately Approximately Revenue Growth 22% to 25% 26 to 28% R&D Expense 20 to 22% 20 to 22% (as a % of revenues) SG&A Expense 22 to 23
Slide 28: Biogen Idec
TITLE OF PRESENTATION BIOGEN IDEC GEORGE SCANGOS, Ph.D., CHIEF EXECUTIVE OFFICER
Slide 29: Biogen Idec: Focused on Execution
Biogen Idec: Focused on Execution Expand our leadership position in MS Multiple potential new product launches Pipeline entering data-rich period Continuing to focus on innovation 29
Slide 30: Questions & Answers
BIOGEN TITLE OFIDEC PRESENTATION QUESTIONS & ANSWERS
Slide 31: Appendix
BIOGEN TITLE OFIDEC PRESENTATION APPENDIX
Slide 32: Neurology Late Stage Programs
Neurology Late Stage Programs DACLIZUMAB Molecule PLEGRIDY TYSABRI OCRELIZUMAB* HYP Trial Name ADVANCE ASCEND DECIDE OPERA I OPERA II ORATORIO Phase Phase III Phase IIIb Phase III Phase III Phase III Phase III Indication RMS SPMS RMS RMS RMS PPMS Administration SC Injection IV/Infusion SC Injection
Slide 33: Hemophilia Late Stage Programs
Hemophilia Late Stage Programs Molecule ALPROLIX ELOCTATE Trial Name B-LONG KIDS B-LONG A-LONG KIDS A-LONG Phase Phase III Phase III Phase III Phase III Indication Hemophilia B Hemophilia B Hemophilia A Hemophilia A Administration IV Infusion IV Infusion IV Infusion IV Infusion Target 123 ~20 ~150 ~
Slide 34: Anti-CD20 Late Stage Programs
Anti-CD20 Late Stage Programs Molecule GAZYVA Trial Name CLL11 GOYA GADOLIN GALLIUM Phase Phase III Phase III Phase III Phase III Rituxan-refractory indolent Front-line Chronic Front-line Diffuse Large B- Front-line iNHL Indication Non Hodgkin‟s Lymphoma Lymphocytic Leukemia cell lymphoma (DLBCL) w/
Slide 35: Late Stage Pipeline Events
Late Stage Pipeline Events PROGRAM PHASE INDICATION EXPECTED MILESTONE 1 Approved in the Pediatric trial KIDS B-LONG ongoing; Hemophilia B US anticipate early May US Launch 1 Filed in US Hemophilia A BLA submission accepted by FDA; anticipate mid-2014 launch in US Filed in US & EU Relapsing forms of
Slide 36: GAAP to Non-GAAP Reconciliation
GAAP to Non-GAAP Reconciliation Use of Non-GAAP Financial Measures TABLE 3 We supplement our consolidated financial statements presented on Biogen Idec Inc. and Subsidiaries a GAAP basis by providing additional measures which may be GAAP to Non-GAAP Reconciliation: Net Income and Net Income Per Shar