Biogen Inc. · NASDAQ:BIIB
Biogen — Q4 2015 Earnings Presentation
36 slides from Biogen's earnings presentation, Jan 27, 2016
Slide 1: Q4 & Full Year 2015 Financial Results and Business Update
Q4 & Full Year 2015 Financial Results and Business Update January 27, 2016 1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements, including statements relating to: Biogen’s commercial business and prospects; investments in, and potential of, pipeline and collaboration programs; anticipated timing of data readouts; potential product approvals and
Slide 3: Q4 2015 Earnings Call Agenda
Q4 2015 Earnings Call Agenda Matt Calistri Introduction Investor Relations George Scangos, Ph.D. Overview Chief Executive Officer Al Sandrock, M.D., Ph.D. R&D Update EVP, Chief Medical Officer Paul Clancy Business Update EVP, Chief Financial Officer George Scangos, Ph.D. Closing Remarks Chief Execut
Slide 4: Overview
Overview George Scangos, Ph.D. Chief Executive Officer 4
Slide 5: Recent Highlights
Recent Highlights Financial Update R&D Progress • 11% growth in revenues and 23% growth in • ELOCTA approved for hemophilia A in the EU non-GAAP diluted EPS year-over-year • Meaningful business development activity in • In 2015, purchased 16.8 million shares of 2015: common stock, completing our $5.
Slide 6: R&D Update
R&D Update Al Sandrock, M.D., Ph.D. EVP and Chief Medical Officer 6
Slide 7: Alzheimer's Disease: Clinical Development Updates
Alzheimer’s Disease: Clinical Development Updates Aducanumab Phase 3 Status • Two ongoing Phase 3 studies, ENGAGE and EMERGE • Factors affecting enrollment: • Challenging to access patients with early Alzheimer’s disease • Limited availability of PET and high screen failure rate • Substantial intere
Slide 8: Anti-LINGO Phase 2 MS Study (SYNERGY) Endpoints
Anti-LINGO Phase 2 MS Study (SYNERGY) Endpoints Composite Primary Endpoint Disability Cognitive Function Physical Function Disability progression Information processing Timed Upper limb (EDSS) learning and memory walking function (PASAT-3) (T25FW) (9HPT) Magnetization Diffusion Tensor Brain Atrophy
Slide 9: Nusinersen for Spinal Muscular Atrophy (SMA)
Nusinersen for Spinal Muscular Atrophy (SMA) Development Status • Phase 3 CHERISH study in children: target enrollment complete • Phase 3 ENDEAR study in infants: enrollment completion anticipated in 1H:16 • Data for both programs anticipated in 1H:17 • Collaboration with Ionis Pharmaceuticals (form
Slide 10: New Hemophilia Data Presented at ASH Conference
New Hemophilia Data Presented at ASH Conference • New data presented demonstrating that ELOCTATE and ALPROLIX may effectively manage target joint bleeding and maintain low annualized bleeding rates in people with severe hemophilia A and B • 3rd party data* from three children with inhibitors showed
Slide 11: Biogen Is Advancing ALS Drug Development
Biogen Is Advancing ALS Drug Development First Patient Dosed January 2016 • Initiated a Phase 1/2 clinical study of IONIS- Survival in SOD1-G93A Rat SOD1Rx (BIIB067) in patients with ALS in PBS December 2015 SOD1 ASO • Superoxide Dismutase 1 (SOD1) is the second most common familial form of ALS, acc
Slide 12: Deep Pipeline
Deep Pipeline PHASE I PHASE II PHASE III FILED ZINBRYTA* Multiple Sclerosis GAZYVA* Rituxan-Refractory Indolent Non Hodgkin’s Lymphoma GAZYVA* Front-Line Indolent Non Hodgkin’s Lymphoma GAZYVA* Front-Line Diffuse Large B-Cell Lymphoma Nusinersen (IONIS-SMNRx)* Spinal Muscular Atrophy Aducanumab (BII
Slide 13: Business Update
Business Update Paul Clancy EVP, Chief Financial Officer 13
Slide 14: 2015 Financial Performance
2015 Financial Performance Diluted EPS ($) Revenues ($B) +24% +23% +11% +12% $10.8 $17.01 $15.34 $9.7 $13.83 $12.37 $9.2 $8.2 2014 2015 2014 2015 2014 2015 2014 2015 GAAP Non-GAAP Total Product A reconciliation of our GAAP to non-GAAP financial results is at the end of this presentation 14
Slide 15: Global TECFIDERA Performance
Global TECFIDERA Performance The Most Prescribed Oral MS Therapy Globally TECFIDERA Revenue ($M) Q4 2015 Highlights $993 • Revenue vs. Q3 2015 and Q4 2014 $916 $937 $883 $208 ∆Q/Q ∆Y/Y $825 $173 $183 WW + 6% and + 8% $163 US + 4% and + 6% $177 ROW + 13% and + 20% • US revenue benefitted by approxima
Slide 16: Global Interferon Performance
Global Interferon Performance Interferon Revenues ($M) Q4 2015 Highlights • Total Interferon Revenue vs. Q3 2015 and Q4 2014 $777 $785 ∆Q/Q ∆Y/Y $755 $740 WW (6%) and (5%) $13 $29 $690 $36 US (6%) and (4%) $22 $235 $24 $218 ROW (6%) and (6%) $214 $197 $211 $28 $40 $71 PLEG ROW • In US, 14 shipping w
Slide 17: Global TYSABRI Performance
Global TYSABRI Performance TYSABRI Revenue ($M) Q4 2015 Highlights • Revenue vs. Q3 2015 and Q4 2014 $484 $480 $481 ∆Q/Q ∆Y/Y $463 $463 WW + 0% and (1%) US (2%) and + 5% $218 $190 $195 $196 $203 ROW + 4% and (7%) • Continued trend of positive patient growth this quarter ROW • Physicians continue to
Slide 18: ELOCTATE Performance
ELOCTATE Performance ELOCTATE Revenue ($M) Q4 2015 Highlights • Revenue vs. Q3 2015 and Q4 2014 $101 ∆Q/Q ∆Y/Y WW + 12% and + 175% $91 $5 US + 10% and + 160% $4 ROW + 47% and NMF $74 $2 • ELOCTA approved in the EU (to be commercialized by $54 ROW Sobi) $0.4 • ROW revenues primarily from Japan $96 US
Slide 19: ALPROLIX Performance
ALPROLIX Performance ALPROLIX Revenue ($M) Q4 2015 Highlights $71 • Revenue vs. Q3 2015 and Q4 2014 $66 $11 ∆Q/Q ∆Y/Y $7 WW + 9% and + 77% $54 US + 2% and + 64% $5 ROW + 63% and + 202% $43 $40 $2 • ROW revenues primarily from Japan $4 • ALPROLIX filed for marketing authorization in EU $59 $60 ROW $4
Slide 20: RITUXAN and GAZYVA Performance
RITUXAN and GAZYVA Performance RITUXAN and GAZYVA Results ($M) $956 $986 $959 $947 $872 $286 $305 $310 $331 $323 $338 $320 $337 $317 $334 $19 $21 $14 $17 $17 Q4-14 Q1-15 Q2-15 Q3-15 Q4-15 1 ROW Royalty BIIB US Profit Share BIIB Revenue US Net Sales Q4 2015 Highlights Revenue vs. Q3 2015 and Q4 2014
Slide 21: Q4 & FY 2015 Financial Results Summary
Q4 & FY 2015 Financial Results Summary Q4 Q3 Q4 FY FY $ in Millions 2014 2015 2015 Q/Q Y/Y 2014 2015 FY/FY Cost of Sales1 $297 $310 $332 (7%) (12%) $1,171 $1,240 (6%) % of Total Revenues 11% 11% 12% 12% 12% Non-GAAP R&D Expenses2 $499 $520 $542 (4%) (9%) $1,888 $2,013 (7%) % of Total Revenues
Slide 22: Q4 & FY 2015 Financial Results Summary
Q4 & FY 2015 Financial Results Summary Q4 Q3 Q4 FY FY $ in Millions 2014 2015 2015 Q/Q Y/Y 2014 2015 FY/FY Other Income (Expense), Net1 ($9) ($15) ($82) (435%) (842%) ($26) ($124) (380%) Non-GAAP Tax Rate2 24% 24% 23% 25% 24% Equity in Loss of Investee, Net of $0 $7 $0 100% 100% $15 $13 17% Ta
Slide 23: 2016 Full Year Financial Guidance
2016 Full Year Financial Guidance Expense ratios apply to both GAAP and Non-GAAP 2016 Full Year Guidance. FY 2016 Guidance Assumptions • Relatively stable demand for TECFIDERA in the US and continued growth in Europe • Continued growth for ELOCTATE and moderating Approximately Revenues patient adds
Slide 24: Closing Remarks
Closing Remarks George Scangos, Ph.D. Chief Executive Officer 24
Slide 25: Biogen: Creating Value in 2016
Biogen: Creating Value in 2016 • Continued focus on commercial execution • Long-term value creation expected to come from pipeline • Multiple upcoming potential value drivers: – Insight into impact of TECFIDERA marketing campaign in Q2:16 – Phase 2 for anti-LINGO-1 in MS expected mid-2016 – Phase 2
Slide 26: Questions & Answers
Questions & Answers 26
Slide 27: Appendix
Biogen Appendix * Biogen.
Slide 28: Q4 & FY 2015 Financial Results Summary: Revenues 1 of 2
Q4 & FY 2015 Financial Results Summary: Revenues 1 of 2 Q4 Q3 Q4 FY FY $ in Millions 2014 2015 2015 Q/Q Y/Y 2014 2015 FY/FY TECFIDERA US $743 $754 $785 4% 6% $2,427 $2,908 20% TECFIDERA ROW $173 $183 $208 13% 20% $483 $730 51% Total TECFIDERA Sales1 $916 $937 $993 6% 8% $2,909 $3,638 25% AVONE
Slide 29: Q4 & FY 2015 Financial Results Summary: Revenues 2 of 2
Q4 & FY 2015 Financial Results Summary: Revenues 2 of 2 Q4 Q3 Q4 $ in Millions FY 2014 FY 2015 2014 2015 2015 Q/Q Y/Y FY/FY ELOCTATE US $37 $87 $96 10% 160% $58 $308 428% ELOCTATE ROW $0 $4 $5 47% NMF $0 $11 NMF Total ELOCTATE Sales $37 $91 $101 12% 175% $58 $320 447% ALPROLIX US $37 $59 $60 2
Slide 30: Neurology Late Stage Programs - MS
Neurology Late Stage Programs - MS Molecule ZINBRYTA1 OCRELIZUMAB2 Trial Name DECIDE OPERA I OPERA II ORATORIO Phase Phase III Phase III Phase III Phase III Indication RMS RMS RMS PPMS Administration SC Injection IV/Infusion IV/Infusion IV/Infusion Target 1,800 800 800 630 Enrollment Active Active A
Slide 31: Neurology Late Stage Programs - Continued
Neurology Late Stage Programs - Continued Molecule Aducanumab1 ISIS-SMNRx2 ISIS-SMNRx2 Trial Name ENGAGE EMERGE ENDEAR CHERISH Phase Phase III Phase III Phase III Phase III Early Alzheimer’s Early Alzheimer’s Disease Disease Infantile-onset Spinal Later-onset Spinal Indication Muscular Atrophy Muscu
Slide 32: Hemophilia Late Stage Programs
Hemophilia Late Stage Programs Molecule ALPROLIX1 ELOCTATE1 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 Enrollment 1
Slide 33: Anti-CD20 Late Stage Programs
Anti-CD20 Late Stage Programs Molecule GAZYVA Trial Name GOYA GADOLIN GALLIUM Phase Phase III Phase III Phase III Rituxan-refractory Front-line Diffuse Large indolent Non Hodgkin’s Front-line iNHL Indication B-cell lymphoma Lymphoma (iNHL) w/maintenance (DLBCL) w/maintenance Administration IV Infusi
Slide 34: Q4 and FY 2015 Impact of Foreign Exchange
Q4 and FY 2015 Impact of Foreign Exchange FX / Hedge Impact FX / Hedge Impact Actuals Favorable / Actuals Favorable / (Unfavorable) (Unfavorable) Versus Versus Q4 2015 FY 2015 Versus FY 2014 Q4 2014 Q3 2015 Total Revenues $2,839 $(35)* $(0)# $10,764 $(227)^ Cost of Sales $332 $5 $3 $1,240 $24 Non-GA
Slide 35: Accounting Treatment for Biosimilars
Accounting Treatment for Biosimilars Overall Samsung Bioepis Economics • Samsung Biologics originally contributed ~$250.0 million for an 85% stake in Samsung Bioepis and Biogen contributed ~$45.0 million for the remaining 15%. As of 12/31/15, Biogen’s ownership interest is ~9%. • Option to increase
Slide 36: GAAP to Non-GAAP Reconciliation
GAAP to Non-GAAP Reconciliation BIOGEN INC. AND SUBSIDIARIES Use of Non-GAAP Financial Measures GAAP TO NON-GAAP RECONCILIATION: We supplement our consolidated financial statements presented on a NET INCOME ATTRIBUTABLE TO BIOGEN INC. AND DILUTED EARNINGS PER SHARE GAAP basis by providing additional