Biogen Inc. · NASDAQ:BIIB
Biogen — Biogen Idec — Q2 2014 Earnings Presentation
35 slides from Biogen's earnings presentation, Jul 23, 2014
Slide 1: Second Quarter 2014 Financial Results & Business Update
TITLE OF PRESENTATION SECOND QUARTER 2014 FINANCIAL RESULTS & BUSINESS UPDATE JULY 23, 2014
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements, including statements about 2014 financial guidance, anticipated regulatory filings and approvals, and anticipated data readouts. These forward-looking statements may be accompanied by such words as “anticipate,” “belie
Slide 3: Q2 2014 Earnings Call Agenda
Q2 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: Q2 2014 Financial Performance
Q2 2014 Financial Performance Non-GAAP Diluted EPS ($)* +40% +48% 2,056 2,421 3.49 2.30 1,723 1,386 Q2-13 Q2-14 GAAP Diluted EPS ($)* 3.01 Q2-14 Q2-13 Q2-14 2.06 Q2-13 Total Revenues ($M) Product Revenues ($M) Q2-13 Q2-14 *A RECONCILIATION OF OUR GAAP TO NON-GAAP FINANCIAL RESULTS IS INCLUDED AT THE
Slide 6: Q2 2014 Highlights
Q2 2014 Highlights PRODUCT PERFORMANCE HEMOPHILIA Strong financial performance driven by a growing ALPROLIX for hemophilia B launched in the US patient base for our MS Franchise ELOCTATE for hemophilia A approved by the FDA and launched in the US in mid-July 40% growth in revenues and 52% growth i
Slide 7: R&D Update
TITLE OF PRESENTATION R&D UPDATE DOUG WILLIAMS, Ph.D., EXECUTIVE VICE PRESIDENT, RESEARCH & DEVELOPMENT
Slide 8: Daclizumab HYP: Potential New Therapeutic Option for Relapsing MS
Daclizumab HYP: Potential New Therapeutic Option for Relapsing MS Phase 3 DECIDE active comparator study (1x Monthly Sub-Q Daclizumab HYP compared to weekly intramuscular IFN β-1a) 45% reduction in annualized relapse rate Monoclonal antibody targeting alpha (p<0.0001) subunit of IL-2 receptor 54
Slide 9: Deep Pipeline
Deep Pipeline PHASE I PHASE II PHASE III FILED ALPROLIX* Hemophilia B FDA APPROVED Late-Stage ELOCTATE* Hemophilia A FDA APPROVED PLEGRIDY Multiple Sclerosis FDA & EU FILED DACLIZUMAB HYP* Multiple Sclerosis POSITIVE TOP LINE RESULTS TYSABRI Secondary Progressive Multiple Sclerosis GAZYVA* Diffuse L
Slide 10: Anti-LINGO-1: Phase 2 in Acute Optic Neuritis and Multiple Sclerosis
Anti-LINGO-1: Phase 2 in Acute Optic Neuritis and Multiple Sclerosis Lead Indication • Multiple Sclerosis Presumed • Fully human, IgG anti‐LINGO mAb Mechanism of • Inhibits Lingo‐1, involved in oligodendrocyte Action differentiation and myelination • Placebo controlled (N=80) with 100mg/kg dosed IV
Slide 11: Commercial Update
TITLE OF PRESENTATION COMMERCIAL UPDATE TONY KINGSLEY, EXECUTIVE VICE PRESIDENT, GLOBAL COMMERCIAL OPERATIONS
Slide 12: Global MS Franchise Performance
Global MS Franchise Performance MS Franchise Sales ($M) +48% 2,030 1,727 1,593 700 1,438 1,370 506 *Note: 398 192 286 TYSABRI sales outside the U.S. included $54 million of 533* previously deferred revenue 387 427 441 401 from February 2013 through March 31, 2014, which was recognized during the qua
Slide 13: Strong TECFIDERA Launch
Strong TECFIDERA Launch TECFIDERA Revenue ($M) Q2 2014 Highlights Revenue vs. Q1 2014 WW + 38% US + 27% 700 ROW + 151% 115 TECFIDERA’s broad use continues 506 46 We believe Tecfidera is on track to becoming the leading 398 MS product in the US 7 286 US retention rates in-line with expectations 585 1
Slide 14: Global AVONEX Performance
Global AVONEX Performance AVONEX Revenues ($M) Q2 2014 Highlights Revenue vs. Q1 2014 & Q2 2013 WW +2% and 0% US +5% and +4% 774 761 774 ROW -3% and -6% 733 751 Units vs. Q1 2014 & Q2 2013 295 277 285 276 WW -3% and -7% 277 US 0% and -11% ROW -4% and -5% AVONEX gained global market share among inter
Slide 15: Global TYSABRI Performance
Global TYSABRI Performance Q2 2014 Highlights TYSABRI Revenue ($M) Revenue vs. Q1 2014 & Q2 2013 533 WW +21% and +38% US +7% and +15% 441 427 ROW +37% and +68% 401 387 284 Units vs. Q1 2014 & Q2 2013 176 207 WW +4% and +4% 169 169 US +11% and +4% ROW -1% and +3% Demand solid, and patient retention r
Slide 16: ALPROLIX Launch Update
ALPROLIX Launch Update $10M Revenue in Q2 2014 Solid start since commercial launch in May As of the end of the quarter, approximately 1/3 of Hemophilia Treatment Centers have prescribed ALPROLIX Distribution and access highlights: Reimbursement favorable Contracting with specialty pharmacies is in p
Slide 17: ELOCTATE Update
ELOCTATE Update US Commercial launch last week, leveraging infrastructure from ALPROLIX Competitive label obtained Focused on educating physicians, payers, and advocacy groups Expediting access to patients Ex-US, approval received in Australia 17
Slide 18: Financial Performance
TITLE OF PRESENTATION FINANCIAL PERFORMANCE PAUL CLANCY, EXECUTIVE VICE PRESIDENT, CHIEF FINANCIAL OFFICER
Slide 19: Q2 2014 GAAP to Non-GAAP Reconciliation
Q2 2014 GAAP to Non-GAAP Reconciliation Q2 2014 YTD GAAP Diluted EPS $3.01 $5.03 GAAP Net Income Attributable to Biogen Idec Inc. ($M) $714.5 $1,194.5 Amortization of Intangibles 113.0 252.8 Contingent Consideration 4.0 3.2 Stock Option Expense 2.7 7.5 Donation to Biogen Idec Foundation 35.0 35.0 Ta
Slide 20: Q2 2014 Financial Results Summary: MS Revenues
Q2 2014 Financial Results Summary: MS Revenues $ in Millions Q2 Q1 Q2 % % 2013 2014 2014 Q/Q Y/Y AVONEX US $479 $476 $498 5% 4% AVONEX ROW $295 $285 $276 (3%) (6%) Total AVONEX Sales1 $774 $761 $774 2% 0% TECFIDERA US $190 $460 $585 27% NMF TECFIDERA ROW $2 $46 $115 151% NMF Total TECFIDERA Sales
Slide 21: Q2 2014 Financial Results Summary: Other Revenues
Q2 2014 Financial Results Summary: Other Revenues $ in Millions Q2 Q1 Q2 % % 2013 2014 2014 Q/Q Y/Y ALPROLIX US -- -- $10 NMF NMF ALPROLIX ROW -- -- -- NMF NMF Total ALPROLIX Sales -- -- $10 NMF NMF FUMADERM Sales $16 $16 $16 3% 1% Total Product Sales $1,386 $1,743 $2,056 18% 48% RITUXAN/GAZYVA US
Slide 22: RITUXAN & GAZYVA Performance
RITUXAN & GAZYVA Performance RITUXAN & GAZYVA Results ($M) 947 Q2 2014 Highlights 876 891 952 Revenue vs. Q2 2013 and Q1 2014 811 806 852 US Net Sales +10% and +2% US Profit Share1 +5% and +4% ROW Royalty -2% and -19% BIIB Revenue +5% and +2% 289 297 303 303 269 271 282 275 285 253 Ongoing Ph. 3 tri
Slide 23: Q2 2014 Financial Results Summary
Q2 2014 Financial Results Summary $ in Millions % % Q2 2013 Q1 2014 Q2 2014 Q/Q Y/Y Cost of Sales1 $231 $279 $292 (5%) (27%) % of Total Revenues 13% 13% 12% Non-GAAP R&D $327 $527 $446 15% (37%) Expenses2 % of Total Revenues 19% 25% 18% Non-GAAP SG&A $430 $509 $540 (6%) (26%) Expenses3 % of Total
Slide 24: Q2 2014 Financial Results Summary
Q2 2014 Financial Results Summary $ in Millions except EPS Q2 Q1 Q2 % % Shares in millions 2013 2014 2014 Q/Q Y/Y Other income (expense), net1 $(10) ($6) $5 NMF NMF Non-GAAP Tax Rate2 24% 27% 27% Equity in Loss of Investee, net of tax3 $2 $8 $2 75% 16% Net Income (loss) Attributable to Non Control
Slide 25: 2014 Full Year Financial Guidance Update
2014 Full Year Financial Guidance Update Meaningful increase from prior guidance owing primarily to the growth of TECFIDERA in the U.S. and the E.U., the strength of our other MS therapies, and clarity on the AIFA pricing matter Expense ratios apply to both GAAP and Prior FY 2014 Updated FY 2014 Non
Slide 26: Increased 2014 Full Year Financial Guidance
Increased 2014 Full Year Financial Guidance GAAP EPS Non‐GAAP EPS Expected between Expected between Prior FY 2014 Guidance $9.85 & $9.95 $11.35 & $11.45 A. AIFA Resolution1 ~$0.25 ~$0.29 B. Core Business Impact2 ~$1.21 ~$1.31 Expected between Expected between Updated FY 2014 Guidance $11.26 & $11.46
Slide 27: Biogen Idec
TITLE OF PRESENTATION BIOGEN IDEC GEORGE SCANGOS, Ph.D., CHIEF EXECUTIVE OFFICER
Slide 28: Biogen Idec: Focused on Execution
Biogen Idec: Focused on Execution Expand our leadership position in MS Multiple potential new product launches Pipeline in a data-rich period Continuing to focus on innovation 28
Slide 29: Questions & Answers
BIOGEN TITLE OFIDEC PRESENTATION QUESTIONS & ANSWERS
Slide 30: Appendix
BIOGEN TITLE OFIDEC PRESENTATION APPENDIX
Slide 31: 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 32: 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 33: 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 34: Late Stage Pipeline Events
Late Stage Pipeline Events PROGRAM PHASE INDICATION STATUS 1 Approved in the Pediatric trial KIDS B-LONG ongoing; PUP Hemophilia B US study enrolling Approved in the Pediatric trial KIDS A-LONG complete; Hemophilia A 1 US PUP study anticipated to start 2H 2014 Filed in US & EU Relapsing forms of MS
Slide 35: 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