Biogen Inc. · NASDAQ:BIIB
Biogen — Biogen Idec — JPMorgan Healthcare Conference 2009
32 slides from Biogen's conference presentation, Jan 13, 2009
Slide 1: Biogen Idec JPMorgan Healthcare Conference
Biogen Idec JPMorgan Healthcare Conference Jim Mullen, CEO Cecil Pickett, President R&D January 13, 2009
Slide 2: Forward Looking Statements
This presentation includes forward-looking statements about: - - estimates of market share and new markets for our products, including the anticipated drivers for future growth - - the potential growth of our international business and entry into new geographic markets - - the anticipated developmen
Slide 3: Agenda
Agenda Strategy & Performance Value Drivers Pipeline
Slide 4: Specialty Markets with Significant Needs
Specialty Markets We pursue markets which have: Concentrated call points High scientific sell Require significant patient / HCP support We do not pursue primary care / mass market Significant Needs We pursue therapeutics against diseases where there is a high unmet medical need Strategy Specialty Ma
Slide 5: First-in-Class or Best-in-Class Molecules
Strategy First-in-Class or Best-in-Class Molecules First-in-class Best-in-class Early Stage Late Stage CDP323 Factor IX Hsp90i IGF1R Lumiliximab Galiximab BG-12 LINGO Adentri Lixivaptan TWEAK Fn14 Neurology Oncology Immuology CV / Emerging PEG-IFN BIIB14 Next Gen CD20s
Slide 6: Global
Strategy Global 2006 2007-2008 2011-2012 2013+ Global Footprint Expanding Specialty markets with significant needs First-in-class or best-in-class molecules Global
Slide 7: Established Track Record and Strong Cash Flow
EPS ($) Revenue ($ Billions) Established Track Record and Strong Cash Flow Note: 2003 is pro forma data for the Biogen and Idec merger. EPS numbers are Non-GAAP which excludes the impact of purchase accounting, merger-related adjustments, stock option expense, and other items and their related tax e
Slide 8: Growth Cycle Ongoing
Growth Cycle Ongoing 2003A 2004A 2005A 2006A 2007A 2008E Consensus Avonex 1168 1417.2 1543.1 1706.7 1868 2196 ROW Rituxan 68 121 147.5 194 251 323 Rituxan/2H7 425 494.7 565 616.7 675 772 Tysabri 3.1 4.7 35.8 230 620 Other 191 175.6 161.5 129 148 180 TYSABRI(r) 3.2 ~4.1 Revenue ($ Billions) 1.9 +17%
Slide 9: Value Drivers
Value Drivers biogen idec |
Slide 10: TYSABRI Efficacy
TYSABRI(r) Efficacy Compelling Physician Perception TYSABRI recognized by >90% of Neurologists as most effective MS therapy Sustained improvement in physical disability in patients with baseline EDSS score ³ 2.0 Cumulative probability of sustained improvement 0.50 0.40 0.40 0.35 0.30 0.25 0.20 0.15
Slide 11: Unmet Need in MS Market
Unmet Need in MS Market 1Polman CH, et al. N Engl J Med. 2006;354:899-910; 2IFNB MS Study Group. Neurology. 1993;43:655-661; 3Jacobs LD, et al. Ann Neurol. 1996;39:285-294; 4PRISMS Study Group. Lancet.1998;352:1498-1504; 5Johnson KP, et al. Neurology. 1995;45:1268-1276. *Calculated for patients who
Slide 12: TYSABRI Utilization and Exposure
TYSABRI(r) Utilization and Exposure Updated Data as of Year End 2008 YE06 YE07 YE08 Intl Commercial 1200 7700 16900 US Commercial 4000 12900 20200 Clincial Trials 700 600 TYSABRI Utilization TYSABRI Post-Marketing Exposure (Patients) 37,600 21,300 5,200 Overall Post-marketing Exposure >12 Months >18
Slide 13: TYSABRI PML Experience
TYSABRI(r) PML Experience Working actively to identify new methods of risk assessment, detection and management Early detection and definitive diagnosis possible Available initial actions include: Halting TYSABRI Plasma exchange Mefloquine 3 of 4 PML patients since 2006 re-launch alive, with varying
Slide 14: Broad and Deep Pipeline (January 2007)
Broad and Deep Pipeline Daclizumab LINGO AVONEX TYSABRI RITUXAN / Ocrelizumab BG-12 BIIB014 Neublastin RITUXAN Ocrelizumab (2nd gen. a-CD20) RITUXAN TYSABRI IMMUNOLOGY Multiple sclerosis Multiple sclerosis Multiple sclerosis Multiple sclerosis Multiple sclerosis Parkinson's Pain MS Rheumatoid arthri
Slide 15: Broad and Deep Pipeline
Broad and Deep Pipeline Daclizumab LINGO CDP323 AVONEX TYSABRI RITUXAN / Ocrelizumab BG-12 BIIB014 Neublastin RITUXAN Ocrelizumab (2nd gen. a-CD20) BG-12 RITUXAN TYSABRI FUMADERM Anti-CD40L Anti-TWEAK IMMUNOLOGY Multiple sclerosis Multiple sclerosis Multiple sclerosis Multiple sclerosis Multiple scl
Slide 16: Pipeline
Pipeline biogen idec |
Slide 17: R&D Strategy
R&D Strategy Focus on novel therapeutics to address areas of high unmet medical need Internal Discoveries and in-licensing opportunities Innovative First-in-Class Molecules as well as Best-in-Class Molecules Preclinical First-in- Human Registration Proof-of- Concept 20 programs 5 programs 11 program
Slide 18: Strong Growth in Phase Programs
Strong Growth in Phase 3 Programs Q108 1H 08 Q308 2H 08 Q109 1H 09 Q309 2H 09 Ph 1 5 5 7 6 6 5 5 5 Ph 2 13 13 12 14 15 15 12 12 Ph 3 4 4 5 5 9 6 11 8 PMC 3 3 3 3 3 3 3 3 Label 25 25 27 30 33 33 31 32 BG12 MS Galiximab Lixivaptan - Hyponatremia Lumiliximab BG12 MS Galiximab Lixivaptan - Hyponatremia
Slide 19: Pipeline Overview
BG-12 PEG-Interferon b-1a Lumiliximab ADENTRI Hsp90 Inhibitor Pipeline Overview
Slide 20: BG-12
BG-12 Dimethyl fumarate, delivered via enterically coated capsule Activates Nrf2 signaling pathway, essential for immune homeostasis and cellular defense Inhibits NFkB and pro-inflammatory cytokine signaling Phase 2b in MS demonstrated 69% reduction in Gadolinium-enhancing lesions Currently in Phase
Slide 21: BG-12 Clinical Program
BG-12 Clinical Program Pivotal trial 2 doses of BG-12 (240mg bid and 240mg tid) and placebo; 1011 pts Primary endpoint: Proportion of patients relapsing over two years Enrollment complete in 1H 2009 Pivotal trial 2 doses of BG-12, glatiramer acetate and placebo; 1232 pts Primary endpoint: Annualized
Slide 22: PEGylated Interferon beta-1a
PEGylated version of Inteferon b-1a delivered via liquid prefilled syringe Modified at the N-terminal ?-amino group Increased half-life and systemic exposure of the protein May improve convenience and compliance for patients with MS who use Interferons PEGylated Interferon Beta-1a molecule, structur
Slide 23: PEGylated Interferon beta-1a Clinical Program
Plan to initiate registration program in mid 2009 Placebo-controlled study in MS; 1260 patients Primary endpoint: Annualized Relapse Rate at 1 year To test biweekly and monthly SC dosing Phase 3 Registration Study Clinical Data (Phase 1) Phase 1 tested three doses over two months Long-acting form ha
Slide 24: Lumiliximab
Lumiliximab Primatized monoclonal Ab that binds CD23 Predominant mechanism of action is apoptotic cell death Induces activation of caspase-9 and caspase-3, and cleavage of PARP in CLL cells Induces down-regulation of anti-apoptotic proteins including Bcl-2, BcL-XL, Mcl-1, and XIAP in CLL cells In ph
Slide 25: Lumiliximab Clinical Program
Phase 2/3 Registration Program FCR +/- Lumiliximab in relapsed CLL Ph II is 390 patients; Ph III is 900 patients Primary endpoints: Phase 2 is CR; Phase 3 is PFS Clinical Data (Phase 1/2) Lumiliximab + FCR in relapsed CLL; 31 patients Doubling of CR vs. historical control (52% vs 25%) Lumiliximab di
Slide 26: Unmet Need in Heart Failure
10M people who suffer from heart failure in the US & EU5 Hyponatremia and renal insufficiency are common co-morbidities in heart failure Unmet Need in Heart Failure Renal Insufficiency (eGFR <60) Hyponatremia (SrNa <135) BIIB Targets 0.65 0.2 Prevalence of Hyponatremia and Renal Insufficiency in ADH
Slide 27: ADENTRI
ADENTRI(r) Three Sites of Adenosine A1 Receptor Blockade Glomerular Capsule Loop of Henle Proximal Tubule Adenosine (A1) Juxtaglomer ular Apparatus Adenosine (A1) Adenosine (A1) Na+ H2O Na+ Na+ Small molecule adenosine receptor antagonist, with high affinity for A1, moderate affinity for A2b recepto
Slide 28: ADENTRI Clinical Program
ADENTRI(r) Clinical Program Pivotal trial of IV formulation 900 acute decompensated heart failure patients with renal insufficiency Primary endpoint: Change in body weight at 24 hours when added to standard therapy Secondary endpoints include renal function, dyspnea, patient global assessment and da
Slide 29: Hsp90 Inhibitor
Small molecule, synthetic Hsp90 inhibitor delivered via oral capsule Hsp90 is a molecular chaperone required for the activity of specific "client" proteins that are involved in tumor cell signaling Inhibition of Hsp90 causes client protein degradation leading to tumor cell stasis and/or death Phase
Slide 30: Delivering Data Readouts and Decision Points
H2 2007 H1 2008 H2 2008 Daclizumab in RRMS - Ph2 (CHOICE) Baminercept in RA - Ph2a RITUXAN in SLE - Ph2/3 RITUXAN in DMARD-IR RA - Ph3 RITUXAN in PPMS - Ph3 BIIB14 in PD - Ph2a Hsp90i in GIST - Ph2a Volociximab in Ovarian - Ph2 RITUXAN in DMARD-naive RA - Ph3 RITUXAN in CLL - Ph3 Positive Readout Ne
Slide 31: R&D Summary
Outstanding people at all levels in the R&D Organization Robust pipeline with important compounds at all stages of development World-class expertise in discovery and development of biologics Focus on executing clinical trials Biogen Idec R&D Day on March 25, 2009 R&D Summary
Slide 32: GAAP to non-GAAP Reconciliation
GAAP to non-GAAP Reconciliation Diluted EPS, Net Income, EBITDA and Free Cash Flow Notes: The non-GAAP financial measures presented in this table are utilized by Biogen Idec management to gain an understanding of the comparative financial performance of the Company. Our non-GAAP financial measures a