Biogen Inc. · NASDAQ:BIIB
Biogen — Biogen Idec — Cowen Healthcare Conference 2009
42 slides from Biogen's conference presentation, Mar 17, 2009
Slide 1: Biogen Idec Cowen Healthcare Conference
Biogen Idec Cowen Healthcare Conference Jim Mullen, CEO March 17, 2009
Slide 2: Forward-looking statements and proxy solicitation notice
This presentation includes forward-looking statements about: - - the potential growth of our international business and entry into new geographic markets - - the anticipated development and timing of, and patient enrollment in, programs in our clinical pipeline - - the sales potential and ability to
Slide 3: Agenda
Agenda Strategy & Performance Reaccelerating TYSABRI Pipeline
Slide 4: Strategy & Performance
Strategy & Performance biogen idec
Slide 5: Strategy: 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 Immunology CV / Emerging PEG-IFN BIIB14 Next Gen CD20s
Slide 6: Strategy: Global Footprint Expanding
Strategy 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: Strong Track Record Continues
Strong Track Record Continues 5 Note: 2003 is pro forma data for the Biogen and Idec merger. EPS and EBITDA numbers are Non-GAAP which excludes the impact of purchase accounting, merger-related adjustments, stock option expense, and other items and their related tax effects. GAAP to non-GAAP EPS and
Slide 8: Growth Cycle Ongoing
Growth Cycle Ongoing 2003 2004 2005 2006 2007 2008 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% CAGR 2.7 2.4 2.2
Slide 9: Reaccelerating TYSABRI
Reaccelerating TYSABRI(r) Focus on unparalleled efficacy Put PML in context
Slide 10: TYSABRI launch versus other therapies
Month ENBREL REMICADE HUMIRA TYSABRI US Intl 1 2343 656 5 1350 802 548 2 10261 3705 29 2614 1337 1277 3 16220 5508 61 4128 3209 920 4 19597 6692 1832 8319 6525 1794 5 29915 4066 6814 9800 7562 2239 6 26675 4647 12274 11333 8143 3189 7 27864 6098 13182 15787 12231 3556 8 34678 4092 15622 15033 11155
Slide 11: The Reality of Multiple Sclerosis
The Reality of Multiple Sclerosis About 40 people testified - mostly patients, some physicians Photo: Boston Globe FDA Advisory Committee Meeting on TYSABRI March 2006
Slide 12: TYSABRI: A Drug That Improves MS
TYSABRI(r) : A Drug That Improves MS Slow - Halt - Reverse Reduction of disease progression Reduction in relapse rate Free of disease activity 54%2 68%2 37%1 Improvement Failure-based paradigm Improvement paradigm Intermediate 69%3 1.Havrdova, et al. Lancet.neurology February 9, 2009 S1474-4422(09)7
Slide 13: Comprehensive Dialogue with Our Customers
Comprehensive Dialogue with Our Customers Thousands of Interactions With Each of Our Audiences Live Programming Med Info Advisory Boards Sales Details Peer-to-Peer Programming Doctors Nurses Nurse Practitioners Patients Patient Associations Pharmacists Regulators Payers PE Specialists Call Centers W
Slide 14: Physician Confidence Dipped, But Is Returning
Physician Confidence Dipped, But Is Returning Jan, 06 Feb, 06 Mar, 06 Q1 '06 Rolling Average Apr, 06 May, 06 June, 06 Q2 '06 Rolling Average H1 2006 July, 06** Aug., 06 Q3 '06 Rolling Average Oct., 06 Nov., 06 Dec., 06 Q4 '06 Rolling Average H2 2006 Jan., 07 Feb., 07 Mar., 07 Q1 '07 Apr., 07 May., 0
Slide 15: Most Neurologists Expect to Increase Use of TYSABRI
Most Neurologists Expect to Increase Use of TYSABRI(r) Q243a. Please indicate how you expect your usage of each of the available MS drug therapies to change over the next six months. *Expected change in usage over six months following fielding. +Countries included: Belgium, France, Germany, Italy, N
Slide 16: Putting PML in Perspective
Putting PML in Perspective PML is difficult to diagnose 5HT2A may be helpful PML can't be treated or cured PML is most often fatal Clinical vigilance appears to be effective at identifying patients early Original results not replicated In vitro evidence for mefloquine Rapid intervention appears to i
Slide 17: Re-defining the TYSABRI PML Experience
Re-defining the TYSABRI(r) PML Experience Rate Outcome 1 / 1000 Less Frequent Less Severe Outcome Available Data at Launch Death or Severe Disability *As of Feb 09. Based on 5 cases with approx 20,000 patients on treatment for >12 months. ZS PhysPulse data - US Neurologists October 2008; EU Neurolog
Slide 18: Re-defining the TYSABRI PML Experience: Rate
Rate Outcome 1 / 1000 Less Frequent Less Severe Outcome Available Data at Launch Death or Severe Disability Re-defining the TYSABRI(r) PML Experience * As of Feb 09. Based on 5 cases with approx 20,000 patients on treatment for >12 months ? 1/4000 over 12 months exposure* Patient Selection Monothera
Slide 19: Emerging Consensus: Drug Holidays Not Recommended
Emerging Consensus: Drug Holidays Not Recommended Drug holiday likely decreases benefit/risk profile of natalizumab In the majority of patients disease activity returns rapidly on cessation of natalizumab No evidence that a drug holiday reduces PML risk - and impractical to test To prove or disprove
Slide 20: MS Disease Activity Returns Rapidly After Cessation of TYSABRI
MS Disease Activity Returns Rapidly After Cessation of TYSABRI(r) Gd+ Lesions by Time Since Final Dose (AFFIRM) Patients With MRI Scan ^2 Months After Last Dose Months Since Last Dose of Natalizumab Prestudy Last On-Study Value 2-3 >3-4 >4-6 >6 (n=109) (n=47) (n=15) (n=25) (n=108) (n=22) 0.0 0.5 1.0
Slide 21: PML Increasingly Linked to Many Drugs
TYSABRI(r) Raised Awareness of PML, but It Is Increasingly Linked to Many Drugs PML included in label Commonly used by neurologists
Slide 22: Further Reducing Risk?
Further Reducing Risk? Basic Science On Potential Risk Factors Immune Function JC Virus Other Host Genetics Viral Genetics Unknown? PML Is an Extremely Rare Event - Likely Results from the Interplay of Multiple Factors
Slide 23: New PML Mitigation Research Consortium
New PML Mitigation Research Consortium Working Together Around a Common Problem Patient profiles Background characteristics Disease features
Slide 24: Pipeline
Pipeline biogen idec
Slide 25: 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 26: 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 TYSABRI FUMADERM Anti-CD40L Anti-TWEAK IMMUNOLOGY Multiple sclerosis Multiple sclerosis Multiple sclerosis Multiple sclerosis Multiple sclerosis M
Slide 27: 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 28: Pipeline Overview
RITUXAN RA - IMAGE BG-12 PEG-Interferon b-1a Lumiliximab ADENTRI HSP90 Pipeline Overview
Slide 29: RITUXAN in Early RA: Phase 3 IMAGE Results
RESULTS: RITUXAN(r) 1000mg improves Total Modified Sharp Score ACR endpoints exceeded expectations; very competitive profile Data results submitted for presentation at EULAR, June 2009 Primary Endpoint: Change of Total Modified Sharp Score vs. Placebo @ 52 weeks Rituxan 1,000 mg Improves Total Modif
Slide 30: BG-12 Dimethyl Fumarate
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 31: 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 32: 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 33: 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 34: 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 35: 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 36: 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 37: ADENTRI: Adenosine A1 Receptor Blockade
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 38: 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 39: 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 40: R&D Day - March 25, 2009
R&D Day - March 25, 2009 Daclizumab LINGO CDP323 AVONEX TYSABRI RITUXAN / Ocrelizumab BG-12 BIIB014 Neublastin RITUXAN Ocrelizumab (2nd gen. a-CD20) BG-12 Ocrelizumab TYSABRI FUMADERM Anti-CD40L Anti-TWEAK IMMUNOLOGY Multiple sclerosis Multiple sclerosis Multiple sclerosis Multiple sclerosis Multipl
Slide 41: Q&A in Breakout Session
Q&A in Breakout Session biogen idec
Slide 42: GAAP to non-GAAP Reconciliation
GAAP to non-GAAP Reconciliation Diluted EPS and Net Income 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 are defined as reported,