Biogen Inc. · NASDAQ:BIIB
Biogen — Q2 2016 Earnings Presentation
37 slides from Biogen's earnings presentation, Jul 21, 2016
Slide 1: Second Quarter 2016 Financial Results and Business Update
Second Quarter 2016 Financial Results and Business Update July 21, 2016 1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements, including statements relating to: Biogen’s commercial business; pipeline and collaboration programs; clinical trials; anticipated data readouts, and data presentations; our search for a new chief executive officer; sha
Slide 3: Q2 2016 Earnings Call Agenda
Q2 2016 Earnings Call Agenda Matt Calistri Introduction Investor Relations George Scangos, Ph.D. Overview Chief Executive Officer Michael Ehlers, M.D., Ph.D. R&D Update EVP, Research & Development Michel Vounatsos Commercial Update EVP, Chief Commercial Officer Paul Clancy Financial Update EVP, Chie
Slide 4: Overview
Overview George Scangos, Ph.D. Chief Executive Officer 4
Slide 5: Second Quarter 2016 Highlights
Second Quarter 2016 Highlights Financial Update Commercial Update • 12% growth in revenues • Announced intent to spin off hemophilia business • 22% growth in GAAP diluted EPS and 23% • ALPROLIX approved in EU for hemophilia B growth in non-GAAP diluted EPS year-over- • TYSABRI label updated in Europ
Slide 6: R&D Update
R&D Update Michael Ehlers, M.D., Ph.D. EVP, Research & Development 6
Slide 7: Revitalizing the Pipeline
Revitalizing the Pipeline • Reshape and progress our pipeline • Aggressively pursue promising assets both internally & externally 7
Slide 8: Clinical Pipeline
Clinical Pipeline PHASE I PHASE II PHASE III FILED ZINBRYTA (daclizumab)* Multiple Sclerosis Approved in US/EU GAZYVA (obinutuzumab)* Rituxan-Refractory Indolent Non Hodgkin’s Lymphoma Approved in US GAZYVA (obinutuzumab)* Front-Line Indolent Non Hodgkin’s Lymphoma Positive Data May‘16 OCREVUS (ocre
Slide 9: UPenn Gene Therapy Collaboration
UPenn Gene Therapy Collaboration • Focused on the development of new gene therapy and gene editing technologies and creating a therapeutic platform for a broad range of diseases • Teamed with renowned gene therapy experts, Dr. James Wilson and Dr. Jean Bennett • Upfront payment of $20 million booked
Slide 10: Commercial Update
Commercial Update Michel Vounatsos EVP, Chief Commercial Officer 10
Slide 11: MS Market Overview
MS Market Overview ~ 2.3 million prevalence, including progressive forms ~ 850k treated patients worldwide, growing in mid single digits ~ 60k patients change therapy each year ~ 300k treated patients ~ 15k new to therapy each year ~ 3/4 stable on current therapy Source: Biogen market research 11
Slide 12: A Global Leader in Multiple Sclerosis
A Global Leader in Multiple Sclerosis $8.6 Biogen products treat ~ 38% of all MS Franchise Sales ($) BILLIONS $8.0 treated MS patients globally3 $5.5 Most prescribed oral Powerful MS A leading worldwide MS therapy therapy therapy for MS $4.1 worldwide $3.8 Biweekly dosing: High efficacy therapy pote
Slide 13: Opportunities Across Key Priorities
Opportunities Across 4 Key Priorities Commercial Medical Portfolio Strategy Trust & Value Excellence Leadership Further define our Increase Further enhance Develop “beyond the strategy for products, sophistication in multi- medical leadership pill” solutions to market segments, and channel marketing
Slide 14: Global TECFIDERA Performance
Global TECFIDERA Performance The Most Prescribed Oral MS Therapy Globally TECFIDERA Revenue ($M) Q2 2016 Highlights $993 • Revenue vs. Q1 2016 and Q2 2015 $987 $937 $946 $883 ∆Q/Q ∆Y/Y $208 $206 WW + 4% and + 12% $183 $202 US + 5% and + 8% $163 ROW + 2% and + 27% • Moderate increase in demand in US
Slide 15: Global Interferon Performance
Global Interferon Performance Interferon Revenues ($M) Q2 2016 Highlights • Total interferon Revenue vs. Q1 2016 and Q2 2015 $785 ∆Q/Q ∆Y/Y $740 $728 WW + 9% and + 6% $690 $29 $36 $670 US + 11% and + 14% $46 $24 $218 $39 ROW + 3% and (11%) $197 $163 $211 $164 $71 PLEG ROW • PLEGRIDY now available in
Slide 16: Global TYSABRI Performance
Global TYSABRI Performance TYSABRI Revenue ($M) Q2 2016 Highlights • Revenue vs. Q1 2016 and Q2 2015 $480 $481 $497 ∆Q/Q ∆Y/Y $463 $477 WW + 4% and + 7% US + 6% and + 14% $189 $192 $195 $196 $203 ROW + 2% and (1%) • Continued trend of positive patient growth this quarter ROW • Well-understood safety
Slide 17: New Product Launches
New Product Launches ZINBRYTA Highlights Biosimilars Highlights • Once-monthly, self-administered, subcutaneous • Strong initial uptake for BENEPALI, the first treatment with demonstrated superior efficacy biosimilar approved in the EU referencing Enbrel® to AVONEX • FLIXABI, a biosimilar referencin
Slide 18: Financial Update
Financial Update Paul Clancy EVP, Chief Financial Officer 18
Slide 19: Q2 2016 Financial Performance
Q2 2016 Financial Performance Revenues ($M) Diluted EPS ($) +12% +12% +22% +23% $2,894 $2,592 $5.21 $2,466 $4.79 $4.22 $3.93 $2,199 Q2-15 Q2-16 Q2-15 Q2-16 Q2-15 Q2-16 Q2-15 Q2-16 Total Product GAAP Non-GAAP A reconciliation of our GAAP to non-GAAP financial results is at the end of this presentatio
Slide 20: Q2 2016 Impact of Foreign Exchange and Hedging
Q2 2016 Impact of Foreign Exchange and Hedging FX Impact w/o Hedge Impact Total Impact Hedge Gains in the Hedge Actuals Favorable/ Favorable/ Quarter Favorable / (Unfavorable) (Unfavorable) (Unfavorable) Vs. Vs. Vs. Vs. Vs. Vs. Q2’16 Q2’16 Q1’16 Q2’15 Q1’16 Q2’15 Q1’16 Q2’15 Q1’16 Q2’15 Total Revenu
Slide 21: Q2 2016 Financial Results Summary: Revenues 1 of 2
Q2 2016 Financial Results Summary: Revenues 1 of 2 $ in Millions Q2 2016 Q1 2016 Q2 2015 Q/Q Y/Y TECFIDERA US $780 $744 $721 5% 8% TECFIDERA ROW $206 $202 $163 2% 27% Total TECFIDERA Sales1 $987 $946 $883 4% 12% AVONEX US $442 $400 $405 11% 9% AVONEX ROW $163 $164 $211 (0%) (22%) Total AVONEX Sa
Slide 22: Q2 2016 Financial Results Summary: Revenues 2 of 2
Q2 2016 Financial Results Summary: Revenues 2 of 2 $ in Millions Q2 2016 Q1 2016 Q2 2015 Q/Q Y/Y ELOCTATE US $110 $99 $72 12% 53% ELOCTATE ROW $14 $9 $2 60% NMF Total ELOCTATE Sales $125 $108 $74 16% 68% ALPROLIX US $63 $65 $49 (2%) 28% ALPROLIX ROW $17 $10 $5 66% 227% Total ALPROLIX Sales $80 $
Slide 23: Q2 2016 Financial Results Summary
Q2 2016 Financial Results Summary $ in Millions Q2 2016 Q1 2016 Q2 2015 Q/Q Y/Y GAAP Cost of Sales $370 $313 $286 (18%) (29%) % of Total Revenues 13% 11% 11% Non-GAAP Cost of Sales $354 $313 $286 (13%) (24%) % of Total Revenues 12% 11% 11% GAAP R&D Expenses $473 $437 $491 (8%) 4% % of Total Reve
Slide 24: Q2 2016 Financial Results Summary
Q2 2016 Financial Results Summary $ in Millions except EPS Q2 2016 Q1 2016 Q2 2015 Q/Q Y/Y Shares in Millions Other Income (Expense), net ($59) ($53) ($11) (11%) (438%) GAAP Tax Rate 25% 27% 24% Non-GAAP Tax Rate 25% 26% 24% Equity in Loss of Investee, net of tax1 $0 $0 $5 NMF NMF Net Income (Lo
Slide 25: Updated 2016 Full Year Financial Guidance Update
Updated 2016 Full Year Financial Guidance Update Expense ratios apply to both Prior FY 2016 Updated FY 2016 Assumptions GAAP and Non-GAAP 2016 Full Year Guidance. Guidance Guidance Approximately Approximately Revenues $11.1 to $11.3 billion $11.2 to $11.4 billion R&D Expense • Includes contribution
Slide 26: Closing Remarks
Closing Remarks George Scangos, Ph.D. Chief Executive Officer 26
Slide 27: Biogen: Areas of Focus
Biogen: Areas of Focus 1 Maximize revenues • Focus on 4 key priorities: portfolio strategy, commercial excellence, medical leadership and trust & value 2 Rapidly advance our pipeline • Reshape the pipeline, rationalize existing programs and aggressively pursue promising assets both internally and ex
Slide 28: Questions & Answers
Questions & Answers 28
Slide 29: Appendix
Biogen Appendix * Biogen.
Slide 30: RITUXAN and GAZYVA Performance
RITUXAN and GAZYVA Performance Revenues from Anti-CD20 Therapeutic Programs ($M) $986 $1,033 $959 $947 $975 $323 $338 $320 $337 $317 $334 $313 $329 $334 $349 $14 $17 $17 $17 $15 Q2-15 Q3-15 Q4-15 Q1-16 Q2-16 1 ROW Royalty BIIB US Profit Share BIIB Revenue US Net Sales Q2 2016 Highlights Revenue vs.
Slide 31: ELOCTATE Performance
ELOCTATE Performance ELOCTATE Revenue ($M) Q2 2016 Highlights • Revenue vs. Q1 2016 and Q2 2015 $125 ∆Q/Q ∆Y/Y $108 $14 WW + 16% and + 68% $101 US + 12% and + 53% $91 $9 ROW + 60% and NMF $5 $74 $4 • ROW revenues include Japan and Canada $2 ROW $110 US $96 $99 $87 $72 Q2-15 Q3-15 Q4-15 Q1-16 Q2-16 N
Slide 32: ALPROLIX Performance
ALPROLIX Performance ALPROLIX Revenue ($M) Q2 2016 Highlights • Revenue vs. Q1 2016 and Q2 2015 ∆Q/Q ∆Y/Y $80 WW + 7% and + 48% $75 US (2%) and + 28% $71 $66 $17 ROW + 66% and + 227% $10 $11 $54 $7 • ROW revenues include Japan and Canada $5 • ALPROLIX approved in the EU ROW $65 $63 $59 $60 US $49 Q2
Slide 33: Neurology Late Stage Programs - MS
Neurology Late Stage Programs - MS Molecule ZINBRYTA1 OCREVUS (OCRELIZUMAB)2 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 Activ
Slide 34: Neurology Late Stage Programs - Continued
Neurology Late Stage Programs - Continued Molecule Aducanumab1 Nusinersen2 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 Muscular Atrophy
Slide 35: 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 36: GAAP to Non-GAAP Reconciliation
GAAP to Non-GAAP Reconciliation Use of Non-GAAP Financial Measures We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered “Non-GAAP” financial measures under applicable SEC rules. We believe that the disclosure of these
Slide 37: GAAP to Non-GAAP Reconciliation
GAAP to Non-GAAP Reconciliation Use of Non-GAAP Financial Measures We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered “Non-GAAP” financial measures under applicable SEC rules. We believe that the disclosure of these