Biogen Inc. · NASDAQ:BIIB
Biogen — Biogen Idec — Q4 2006 Earnings Presentation
30 slides from Biogen's earnings presentation, Feb 15, 2007
Slide 1: Biogen Idec Q4 and FY 2006 Earnings Conference Call and Webcast
Biogen Idec Q4 and FY 2006 Earnings Conference Call and Webcast February 15, 2007
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains forward-looking statements about the launch of TYSABRI(r) (natalizumab) and our financial guidance for 2007. In addition, in the course of the presentation, we may provide additional information of a forward-looking nature. Forward-looking statements
Slide 3: Q4 and FY 2006 Earnings Call Agenda
Q4 and FY 2006 Earnings Call Agenda Introduction Elizabeth Woo, VP Investor Relations Overview Jim Mullen, CEO Tysabri Launch Bob Hamm, SVP Neurology SBU Financial Performance Peter Kellogg, CFO Q&A ALL
Slide 4: Business Overview
James Mullen Chief Executive Officer Business Overview
Slide 5: Overview: Executing on Three Key Value Drivers
Overview Executing on Three Key Value Drivers: Reinvestment in the Pipeline TYSABRI(r) Efficacy Delivering Long-Term Financial Results
Slide 6: Business Development Momentum: Six Deals In Less Than A Year
Business Development Momentum Six Deals In Less Than A Year HSP90 Inhibitors Oncology FUMADERM(r) (fumaric acid esters) Psoriasis BG-12 MS, Psoriasis Aviptadil PAH RNAi therapy PML CDP323 MS FIX:Fc & rFXIII Hemophilia May 2006 May 2006 September 2006 September 2006 October 2006 January 2007
Slide 7: Significant Reinvestment in the Pipeline
Significant Reinvestment in the Pipeline Progress over last 12 months: Building business development momentum Expanding into new therapeutic areas Initiating late-stage registrational trials BG-12 for MS Galiximab (anti-CD80 MAb) for NHL Lumiliximab (anti-CD23 MAb) for CLL Adding talent David Parkin
Slide 8: TYSABRI Launch Approach
TYSABRI(r) Launch Approach Phase 1 H2 2006 Prepare the Foundation Phase 2 2007 Reinforce Efficacy & Broaden Use RiskMAP & TOUCHTM education Infusion site capacity Payor access Benefit-Risk and Fair Balance Broaden use with proper patient selection Launch Focus
Slide 9: Limitations of Current Therapies
Limitations of Current Therapies Partial or no response to ß IFNs & COPAXONE(tm) Flu-like symptoms Dosing too frequent Don't want injection responsibility/inconvenience Multiple Sclerosis Market Unmet Need Remains High TYSABRI(r) 2-year Phase 3 efficacy - Relapse rate reduced by 2/3 No flu-like symp
Slide 10: TYSABRI Launch
Bob Hamm SVP, Neurology Strategic Business Unit TYSABRI(r) Launch
Slide 11: TYSABRI Launch Update
TYSABRI(r) Launch Update Initial U.S. rollout of TOUCH program complete Patients seeking alternatives to existing products Patients switching from all therapies Nearly 10,000 patients prescribed TYSABRI(r) worldwide to date: International: ~1,600 patients U.S.: ~5,000 patients on therapy; ~3,000 pat
Slide 12: TYSABRI Launch Status
TYSABRI(r) Launch Status H2 2006 Launched H1 2007 H2 2007 Expected U.S. Germany Ireland Sweden Denmark Netherlands Finland Norway Austria UK Launched: Italy Canada Slovakia Expected: Luxembourg France Switzerland Spain Belgium Czech Republic Slovenia Portugal Australia Reimbursement in Place
Slide 13: 2/3 Reduction in Relapses
0.23 3-Year Analysis Relapse reduction sustained over 3 years 0.73 0.23 2-Year Analysis 42% reduction in risk of increased disability 68% p<0.001 TYSABRI(r) 2/3 Reduction in Relapses Placebo n=315 Natalizumab n=627 68% Annualized Relapse Rate (95% CI) 0.81 0.26 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.
Slide 14: TYSABRI MRI Efficacy Data
TYSABRI(r) MRI Efficacy Data Gd+ Lesions (2 yrs) % of patients with: Tysabri (n=627) Placebo (n=315) 0 lesions 97% 72% 1 lesion 2% 12% 2 or more lesions 1% 16% Note: Data from TYSABRI label p value <0.001 Gadolinium-enhancing - Currently active MS disease process T2-weighted hyperintense - Total bra
Slide 15: TYSABRI U.S. Source of Patients
ABCR Switcher 69% Other 31% TYSABRI(r) U.S. Source of Patients COPAXONETM most switched from product (January 2007) 34% 31% 15% 20% AVONEX(r) (interferon beta-1a) BETASERONTM (interferon beta-1b)* COPAXONETM (glatiramer acetate)* REBIFTM (interferon beta-1a)* January ABCR Switchers TYSABRI(r) source
Slide 16: TYSABRI U.S. Reimbursement Status Update
TYSABRI(r) U.S. Reimbursement Status Update 95% of private payer patients have good access to TYSABRI(r) 40% of patients have no prior usage requirements 55% of patients have one agent prior usage required TYSABRI(r) has broad access within public payers 100% of Medicare patients have access to TYSA
Slide 17: Start with AVONEX ... For Lasting Efficacy
Start with AVONEX(r) ... For Lasting Efficacy $1.71 B $1.54 B Most prescribed MS therapy - 11 years as market leader +11%
Slide 18: Multiple Therapeutic Approaches to MS
Multiple Therapeutic Approaches to MS T cell B cell DACLIZUMAB: Modifies the immune system response BG 12: Modifies the immune system response RITUXAN(r): Marks B-Cells for destruction NOGO: Triggers regeneration of nerves AVONEX(r): Modifies the immune system response LINGO: Repairs Myelin TYSABRI(
Slide 19: Leading Multiple Sclerosis Franchise
Leading Multiple Sclerosis Franchise AVONEX(r) - #1 prescribed MS therapy worldwide TYSABRI(r) - New level of efficacy Pipeline - Best and broadest for the future
Slide 20: Financial Performance
Peter Kellogg Chief Financial Officer Financial Performance
Slide 21: Q4 and FY 2006 Financial Worksheet: Revenues
Q4 and FY 2006 Financial Worksheet Revenues ($ millions) Q4 2005 Q4 2006 %D FY 2005 FY 2006 %D Notes AVONEX(r) U.S. Revenues 242 261 8% 939 1,022 9% AVONEX(r) International Revenues 171 178 4% 604 685 13% Total AVONEX(r) Sales 413 439 6% 1,543 1,707 11% TYSABRI(r) Revenue to BIIB (0.2) 18 - 5 36 620
Slide 22: Q4 and FY 2006 Financial Worksheet: Costs and Expenses
Q4 and FY 2006 Financial Worksheet Costs and Expenses ($ millions) Q4 2005 Q4 2006 %D FY 2005 FY 2006 %D Notes Non-GAAP Cost of Sales1 72 62 (14%) 303 266 (12%) % of Product Revenues 17% 13% 19% 15% Non-GAAP R&D Expenses2 168 197 17% 725 699 (4%) % of Total Revenues 27% 28% 30% 26% Non-GAAP SG&A Exp
Slide 23: Q4 and FY 2006 Financial Worksheet: Other Selected Financials
Q4 and FY 2006 Financial Worksheet Other Selected Financials ($ millions) Q4 2005 Q4 2006 %D FY 2005 FY 2006 %D Notes Other income, Net $12 ($11) - $20 $52 160% Non-GAAP Tax Rate1 33% 30% 31% 31% Non-GAAP Net Income2 $165 $184 12% $542 $777 43% Weighted Average Shares Outstanding (millions) 345 343
Slide 24: 2007 Financial Guidance
2007 Financial Guidance Mid-teens revenue growth Key drivers: TYSABRI(r) and RITUXAN(r) RA launches Similar margins as 2006 Except for R&D: Expected to be 27 - 29% of Total Revenues Assumes slightly higher level of new business development Non-GAAP EPS $2.50 - $2.65 Excludes FAS123R stock option exp
Slide 25: Summary
James Mullen Chief Executive Officer Summary
Slide 26: 2007 Focus
2007 Focus Driving TYSABRI Business Development Organic pipeline Initiating several proof-of-concept trials May 17th R&D Day hosted by Cecil Pickett Delivering financial results to achieve long-term growth goals
Slide 27: Reconciliation
biogen idec Reconciliation
Slide 28: GAAP to non-GAAP Reconciliation: Q4/FY 2005 & 2006
GAAP to non-GAAP Reconciliation Diluted EPS and Net Income: Q4/FY 2005 & 2006 Note: Numbers may not foot due to rounding.
Slide 29: GAAP to non-GAAP Reconciliation: Four Year History
GAAP to non-GAAP Reconciliation Diluted EPS and Net Income: Four Year History Condensed Consolidated Statements of Income - Operating Basis FY 2003 FY 2004 FY 2005 FY 2006 GAAP diluted EPS ($4.92) $0.07 $0.47 $0.63 Adjustment to net income (see below) 6.14 1.38 1.10 1.62 Effect of FAS128 and ETIF 03
Slide 30: Questions & Answers
biogen idec Questions & Answers