Biogen Inc. · NASDAQ:BIIB
Biogen — Q4 2014 Earnings Presentation
34 slides from Biogen's earnings presentation, Jan 29, 2015
Slide 1: Q4 & Full Year 2014 Financial Results & Business Update
TITLE OF PRESENTATION Q4 & FULL YEAR 2014 FINANCIAL RESULTS & BUSINESS UPDATE JANUARY 29, 2015
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements, including statements about our business strategy, the potential of recently launched products, our pipeline and the development of new treatments and biosimilars, anticipated regulatory filings and data readouts, busin
Slide 3: Q4 & FY 2014 Earnings Call Agenda
Q4 & FY 2014 Earnings Call Agenda INTRODUCTION: CARLO TANZI, Ph.D., Director, 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 PERFOR
Slide 4: Overview
TITLE OF PRESENTATION OVERVIEW GEORGE SCANGOS, Ph.D., CHIEF EXECUTIVE OFFICER
Slide 5: 2014 Financial Performance
2014 Financial Performance Non-GAAP Diluted EPS ($)* +40% +48% 9,703 13.83 8,203 8.96 6,932 5,542 2013 2014 GAAP Diluted EPS ($)* 12.37 2013 2014 2013 2014 7.81 Total Revenues ($M) Product Revenues ($M) 2013 2014 *A RECONCILIATION OF OUR GAAP TO NON-GAAP FINANCIAL RESULTS IS AT THE END OF THIS PRESE
Slide 6: Recent Highlights
Recent Highlights PRODUCT PERFORMANCE Strong financial performance driven by four new products in R&D HIGHLIGHTS two distinct therapeutic markets Positive Phase 3 ZINBRYTA results 40% growth in revenues and 54% growth in non- GAAP diluted EPS year-over-year Phase 3 initiated for Isis SMN-Rx in SMA S
Slide 7: R&D Update
TITLE OF PRESENTATION R&D UPDATE DOUG WILLIAMS, Ph.D., EXECUTIVE VICE PRESIDENT, RESEARCH & DEVELOPMENT
Slide 8: Deep Pipeline
Deep Pipeline PHASE I PHASE II PHASE III FILED Late-Stage ZINBRYTA* Multiple Sclerosis TYSABRI Secondary Progressive Multiple Sclerosis GAZYVA* Diffuse Large B-Cell Lymphoma GAZYVA* Indolent Non-Hodgkin’s Lymphoma (Refractory & Frontline) ISIS-SMNRx* Spinal Muscular Atrophy BIIB037*† Alzheimer's Dis
Slide 9: Business Development Strengthening Pipeline
Business Development Strengthening Pipeline * Acquisition expands Biogen Idec’s portfolio to Expands Biogen Idec gene therapy R&D include several therapeutic candidates for efforts neuropathic pain Collaboration aims to develop gene therapy Convergence assets strengthen our R&D for the treatment of
Slide 10: Commercial Update
TITLE OF PRESENTATION COMMERCIAL UPDATE TONY KINGSLEY, EXECUTIVE VICE PRESIDENT, GLOBAL COMMERCIAL OPERATIONS
Slide 11: Global MS Franchise Performance
Global MS Franchise Performance MS Franchise Sales ($M)* +38% 2,195 2,030 2,054 1,727 1,593 916 700 787 506 398 # 533 501 484 427 441 41 3 751 761 774 742 736 17 19 22 20 19 Q4-13 Q1-14 Q2-14 Q3-14 Q4-14 FAMPYRA AVONEX PLEGRIDY TYSABRI TECFIDERA Note: Numbers may not foot due to rounding. * In the U
Slide 12: Global TECFIDERA Performance
Global TECFIDERA Performance TECFIDERA Revenue ($M) Q4 2014 Highlights Revenue vs. Q3 2014 WW + 16% US + 16% 916 ROW + 16% 787 In US, 14 shipping weeks in Q4 2014 versus 13 in all other 173 quarters shown 700 149 Continued strong uptake across multiple markets 115 506 Recent US performance impacted
Slide 13: Global Interferon Performance
Global Interferon Performance Interferon Revenues ($M) Q4 2014 Highlights 774 745 777 751 761 Total Interferon Revenue vs. Q3 2014 & Q4 2013 3 13 WW +4% and +3% 276 235 US +10% and +11% 277 285 260 ROW -5% and -10% 28 In US, 14 shipping weeks in Q4 2014 versus 13 in all other quarters shown PLEGRIDY
Slide 14: Global TYSABRI Performance
Global TYSABRI Performance TYSABRI Revenue ($M) 533 501 484 Q4 2014 Highlights 441 427 1 Revenue vs. Q3 2014 & Q4 2013 284 226 218 WW -3% and +13% 176 207 US -3% and +6% ROW -4% and +24% In the US, there were 13 shipping weeks in Q4 2014 versus 13 in Q4 2013, 12 in Q1 2014, 13 in Q2 2014, and 275 26
Slide 15: ALPROLIX Performance
ALPROLIX Performance ALPROLIX Revenue ($M) 40 4 Q4 2014 Highlights 25 US market share estimated in low teens 0.2 In the US, most patients starting with 1x/week 37 prophylactic dosing schedule 10 25 ROW revenues primarily from Japan Pediatric study readout expected H1 2015; 10 PUPs* study currently e
Slide 16: ELOCTATE Performance
ELOCTATE Performance Q4 2014 Highlights US market share estimated in mid-single digits 37 Approved in Japan ELOCTA (tradename in the EU) filed for 22 marketing authorization in EU PUPs* study currently enrolling Q3-14 Q4-14 ROW US 16 16 * Previously Untreated Patients
Slide 17: Financial Performance
TITLE OF PRESENTATION FINANCIAL PERFORMANCE PAUL CLANCY, EXECUTIVE VICE PRESIDENT, CHIEF FINANCIAL OFFICER
Slide 18: Q4 & FY 2014 GAAP to Non-GAAP Reconciliation
Q4 & FY 2014 GAAP to Non-GAAP Reconciliation Q4 2014 FY 2014 GAAP Diluted EPS $3.74 $12.37 GAAP Net Income Attributable to Biogen Idec Inc. ($M) $883.5 $2,934.8 Amortization of Intangibles ($M) 101.4 472.9 Contingent Consideration ($M) 7.3 (38.9) Stock Option Expense ($M) 2.1 12.2 Donation to Biogen
Slide 19: Q4 & FY 2014 Financial Results Summary: Revenues 1 of 2
Q4 & FY 2014 Financial Results Summary: Revenues 1 of 2 $ in Millions Q4 Q3 Q4 %D %D FY FY %D ($) Millions 2013 2014 2014 Q/Q Y/Y 2013 2014 FY/FY TECFIDERA US $390 $638 $743 16% 90% $864 $2,427 181% TECFIDERA ROW $7 $149 $173 16% NMF $12 $483 NMF Total TECFIDERA Sales1 $398 $787 $916 16% 130% $876 $
Slide 20: Q4 & FY 2014 Financial Results Summary: Revenues 2 of 2
Q4 & FY 2014 Financial Results Summary: Revenues 2 of 2 $ in Millions Q4 Q3 Q4 %D %D FY FY %D ($) Millions 2013 2014 2014 Q/Q Y/Y 2013 2014 FY/FY ALPROLIX US $0 $25 $37 46% NMF $0 $72 NMF ALPROLIX ROW $0 $0 $4 NMF NMF $0 $4 NMF Total ALPROLIX Sales $0 $25 $40 59% NMF $0 $76 NMF ELOCTATE US $0 $22 $3
Slide 21: RITUXAN & GAZYVA Performance
RITUXAN & GAZYVA Performance RITUXAN & GAZYVA Results ($M) 917 Q4 2014 Highlights 876 891 872 Revenue vs. Q3 2014 and Q4 2013 806 US Net Sales -5% and +8% US Profit Share1,2 +6% and +13% ROW Royalty -6% and +11% BIIB Revenue2 +5% and +13% 303 305 269 297 291 275 285 286 253 271 Ongoing Ph. 3 trials
Slide 22: Q4 & FY 2014 Financial Results Summary
Q4 & FY 2014 Financial Results Summary $ in Millions Q4 Q3 Q4 %D %D FY FY %D 2013 2014 2014 Q/Q Y/Y 2013 2014 FY/FY Cost of Sales1 $259 $303 $297 2% (15%) $858 $1,171 (37%) % of Total Revenues 13% 12% 11% 12% 12% Non-GAAP R&D Expenses2 $421 $416 $499 (20%) (18%) $1,440 $1,888 (31%) % of Total Revenu
Slide 23: Q4 & FY 2014 Financial Results Summary
Q4 & FY 2014 Financial Results Summary $ in Millions Q4 Q3 Q4 %D %D FY FY %D 2013 2014 2014 Q/Q Y/Y 2013 2014 FY/FY Other Income (Expense), Net1 ($5) ($16) ($9) 46% (62%) ($35) ($26) 26% Non-GAAP Tax Rate2 29% 25% 24% 24% 25% Equity in Loss of Investee, Net of Tax3 $5 $5 $0 96% 96% $17 $15 (12%) Net
Slide 24: 2015 Full Year Financial Guidance Update
2015 Full Year Financial Guidance Update Expense ratios apply to both GAAP and Non-GAAP 2015 Full Year Guidance. FY 2015 Guidance Approximately Revenue Growth 14 to 16% R&D Expense 19 to 20% (as a % of revenues) SG&A Expense 20 to 21% (as a % of revenues) Expected between GAAP EPS $15.45 and $15.85
Slide 25: Biogen Idec
TITLE OF PRESENTATION BIOGEN IDEC GEORGE SCANGOS, Ph.D., CHIEF EXECUTIVE OFFICER
Slide 26: Biogen Idec: Focused on Execution
Biogen Idec: Focused on Execution Productive year with multiple launches Strong focus on business development Multiple pipeline readouts expected in 2015 26
Slide 27: Questions & Answers
BIOGEN TITLE OFIDEC PRESENTATION QUESTIONS & ANSWERS
Slide 28: Appendix
BIOGEN TITLE OFIDEC PRESENTATION APPENDIX
Slide 29: Neurology Late Stage Programs
Neurology Late Stage Programs Molecule ISIS-SMNRx1 ISIS-SMNRx1 TYSABRI ZINBRYTA2 OCRELIZUMAB2 Trial Name ENDEAR CHERISH ASCEND DECIDE OPERA I OPERA II ORATORIO Phase Phase III Phase III Phase IIIb Phase III Phase III Phase III Phase III Infantile-onset Later-onset Spinal Indication Spinal Muscular M
Slide 30: 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 31: 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 32: Q4 2014 Impact of Foreign Exchange
Q4 2014 Impact of Foreign Exchange COMPARED WITH THE SAME QUARTER OF LAST YEAR Q4 2014 FX / Hedge Impact Favorable / (Unfavorable) Total Revenue $2,641 $(17)* (1)% Cost of Sales $297 $6 2% Non-GAAP R&D $499 $3 1% Expenses Non-GAAP SG&A $573 $14 2% Expenses Note: Amounts are in ($) Millions. See end
Slide 33: FY 2014 Impact of Foreign Exchange
FY 2014 Impact of Foreign Exchange COMPARED WITH THE PRIOR YEAR FY 2014 FX / Hedge Impact Favorable / (Unfavorable) Total Revenue $9,703 $4* 0% Cost of Sales $1,171 $(1) (0)% Non-GAAP R&D $1,888 $(3) (0)% Expenses Non-GAAP SG&A $2,191 $10 0% Expenses Note: Amounts are in ($) Millions. See end of thi
Slide 34: GAAP to Non-GAAP Reconciliation
GAAP to Non-GAAP Reconciliation Biogen Idec Inc. and Subsidiaries Use of Non-GAAP Financial Measures We supplement our consolidated financial statements presented on a GAAP to Non-GAAP Reconciliation: GAAP basis by providing additional measures which may be considered Net Income Attributable to Biog