Slide 1: Biogen Idec Q4 and FY 2008 Earnings Conference Call and Webcast
Biogen Idec Q4 and FY 2008 Earnings Conference Call and Webcast February 6, 2009
Slide 2: Forward-looking statements
This presentation includes forward-looking statements about: our 2009 guidance and our financial and operational goals through 2010 our expected revenues (including royalty revenues), earnings, cash flows, and tax rate estimates of sales for our products and the size and growth of the markets for ou
Slide 3: Q4 and FY 2008 Earnings Call Agenda
Q4 and FY 2008 Earnings Call Agenda Introduction Elizabeth Woo, Vice President, Investor Relations Overview Jim Mullen, Chief Executive Officer Commercial Update Bill Sibold, Senior Vice President, US Commercial R&D Update Dr. Cecil Pickett, President, Research & Development Financial Performance Pa
Slide 4: Business Overview
James Mullen Chief Executive Officer Business Overview
Slide 5: 2008 Full Year Overview
2008 Full Year Overview Robust Full Year 2008 Financial Performance Top Line Exceeded $4 billion goal for revenues Revenue growth y/y of 29% Bottom Line Exceeded net income of $750 million for GAAP and $1 billion for non-GAAP Diluted EPS growth y/y of 33% for GAAP and 34% for non-GAAP Outstanding Pr
Slide 6: 2010 Goals
2010 Goals TYSABRI(r) patients on therapy exceeds 100,000 by year end 2010 AVONEX(r) maintains its patient market share in the "ABCR" market Anti-CD20 franchise growth fueled by filings in at least 2 additional indications Over 40% of revenue from International business 2 new products or indications
Slide 7: 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 8: MS Franchise Update
Bill Sibold Senior Vice President MS Franchise Update
Slide 9: Leading Multiple Sclerosis Franchise
Leading Multiple Sclerosis Franchise AVONEX(r) - #1 prescribed MS therapy worldwide TYSABRI(r) - New level of efficacy 2009 Marketing Plan Further communicate TYSABRI's unprecedented efficacy Increase physician comfort in diagnosing and treating PML Translate improved benefit/risk understanding into
Slide 10: Most prescribed MS therapy & years as market leader
Most prescribed MS therapy & 12 years as market leader Q4-07 Q1-08 Q2-08 Q3-08 Q4-08 AVONEX U.S. Sales (in $ millions) 279 308 306 322 341 AVONEX International Sales (in $ millions) 223.5 228 221 252 225 +13% Global Revenue Growth AVONEX(r) ... Disrupts Disease Not Patients' Lives
Slide 11: TYSABRI Utilization and Exposure
TYSABRI(r) Utilization and Exposure 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 Months >24 M
Slide 12: TYSABRI Efficacy
TYSABRI(r) Efficacy Compelling Physician Perception TYSABRI recognized by >90% of Neurologists as most effective MS therapy Note: Tysabri data presented at 2008 ECTRIMS meeting, Munschauer et al. P474. Physician perception based on October 2008 Biogen Idec market research. Q10_max Wave 5, n=219 Phys
Slide 13: 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 14: TYSABRI Approved in More than 40 Countries
Launched countries listed in dark blue Launched in 27 countries: TYSABRI(r) Approved in More than 40 Countries Countries with Greater than 10% MS Market Share Denmark Greece Iceland Ireland Sweden Switzerland
Slide 15: R&D Update
Cecil Pickett, Ph.D. President, R&D R&D Update
Slide 16: TYSABRI PML Experience & Goals
TYSABRI(r) PML Experience & Goals 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 4 of 5 PML patients since 2006 re-launch alive, with
Slide 17: 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 - Ph2/3 BIIB14 in PD - Ph2a Hsp90 inhibitor in GIST - Ph2a Volociximab in Ovarian - Ph2 RITUXAN in DMARD-naive RA - Ph3 RITUXAN in CLL - Ph3 Positive
Slide 18: Additional 2008 Pipeline Progress
Additional 2008 Pipeline Progress Initiated three proof of concept studies TYSABRI in multiple myeloma BG-12 in rheumatoid arthritis AVONEX in ulcerative colitis Five programs went into the clinic and started first in human trials Anti-IGF-1R in solid tumors Anti-CRIPTO in solid tumors Anti-TWEAK in
Slide 19: Late Stage Programs in Registrational Trials
Late Stage Programs in Registrational Trials Indication RRMS CLL NHL Hyponatremia / ADHF Acute Decompensated HF Lupus Nephritis Rheumatoid Arthritis Lupus Nephritis Program (Ph3 Trials) BG-12 (DEFINE, CONFIRM) Lumiliximab (LUCID) Galiximab (TARGET) Lixivaptan (BALANCE) ADENTRI(r) (TRIDENT) RITUXAN(r
Slide 20: Strong Growth in Novel Registrational Programs
Strong Growth in Novel Registrational 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 -
Slide 21: PEGylated Interferon beta-1a
PEGylated version of Interferon 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, structu
Slide 22: 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 23: Financial Performance
Paul Clancy Chief Financial Officer Financial Performance
Slide 24: AVONEX & RITUXAN Revenue Growth
AVONEX(r) & RITUXAN(r) Revenue Growth Q4-07 Q1-08 Q2-08 Q3-08 Q4-08 AVONEX Worldwide Sales (in $ millions) 502.5 536.1 527.2 574 565.8 Q4-07 Q1-08 Q2-08 Q3-08 Q4-08 BIIB Revenue (in $ millions) 253.7 247 279 299 303 US Net Sales (in $ millions) 596 605 651 655 677 AVONEX(r) RITUXAN(r) +13% Y/Y +20%
Slide 25: Q4 2008 Financial Worksheet: Revenues
Q4 2008 Financial Worksheet Revenues (in $ millions) Q4 07 Q4 08 %D 2007 2008 %D Notes AVONEX(r) U.S. Revenues $279 $341 22% $1,085 $1,277 18% AVONEX(r) International Revenues $224 $225 1% $783 $926 18% Total AVONEX(r) Sales $503 $566 13% $1,868 $2,203 18% TYSABRI(r) Revenue to BIIB $90 $156 74% $23
Slide 26: Q4 2008 Financial Worksheet: Costs and Expenses
Q4 2008 Financial Worksheet Costs and Expenses ($ millions) Q4 07 Q4 08 %D 2007 2008 %D Notes Non-GAAP Cost of Sales1 $88 $101 16% $335 $402 20% % of Product Sales 14.6% 13.8% 15.7% 14.2% Non-GAAP R&D Expenses2 $226 $288 28% $911 $1,057 16% % of Total Revenues 25.3% 27.0% 28.7% 25.8% Non-GAAP SG&A E
Slide 27: Q4 2008 Financial Worksheet: Other Selected Financials
Q4 2008 Financial Worksheet Other Selected Financials ($ millions except EPS) Q4 07 Q4 08 %D 2007 2008 %D Notes Other income (expense), net1 ($2) ($36) na $59 ($70) na Non-GAAP Tax Rate2 29.2% 28.0% 27.8% 29.3% Non-GAAP Net Income3 $266 $274 3% $879 $1,081 23% Weighted average shares used in calcula
Slide 28: Financial Guidance
Financial Guidance Guidance for Full Year 2009 Revenue growth is expected to be in the high single digits. This includes the expected decline in the RITUXAN rest of world revenues, and the recent strengthening of the U.S. dollar. Operating Expenses, excluding collaboration profit share, between $2.0
Slide 29: Questions & Answers
biogen idec Questions & Answers
Slide 30: GAAP to non-GAAP Reconciliation: Q4 and FY 2008
GAAP to non-GAAP Reconciliation Diluted EPS and Net Income: Q4 and FY 2008 Use of Non-GAAP Financial Measures Our "non-GAAP net income" and "non-GAAP diluted EPS" financial measures exclude the following items from GAAP net income and diluted EPS: 1. Purchase accounting and merger-related adjustment
Slide 31: GAAP to non-GAAP Reconciliation: Five Year History
GAAP to non-GAAP Reconciliation Diluted EPS and Net Income: Five Year History 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 de