defa14a - SEC.gov | HOME Franchise Durability 2009 2010+ Granted method of use patent through 2026...
Transcript of defa14a - SEC.gov | HOME Franchise Durability 2009 2010+ Granted method of use patent through 2026...
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0000950123-10-013729.txt : 201002170000950123-10-013729.hdr.sgml : 2010021720100217163057ACCESSION NUMBER:0000950123-10-013729CONFORMED SUBMISSION TYPE:DEFA14APUBLIC DOCUMENT COUNT:12FILED AS OF DATE:20100217DATE AS OF CHANGE:20100217EFFECTIVENESS DATE:20100217
FILER:
COMPANY DATA:COMPANY CONFORMED NAME:BIOGEN IDEC INC.CENTRAL INDEX KEY:0000875045STANDARD INDUSTRIAL CLASSIFICATION:BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]IRS NUMBER:330112644STATE OF INCORPORATION:DEFISCAL YEAR END:1231
FILING VALUES:FORM TYPE:DEFA14ASEC ACT:1934 ActSEC FILE NUMBER:000-19311FILM NUMBER:10613172
BUSINESS ADDRESS:STREET 1:14 CAMBRIDGE CENTERCITY:CAMBRIDGESTATE:MAZIP:02142BUSINESS PHONE:6176792000
MAIL ADDRESS:STREET 1:14 CAMBRIDGE CENTERCITY:CAMBRIDGESTATE:MAZIP:02142
FORMER COMPANY:FORMER CONFORMED NAME:BIOGEN IDEC INCDATE OF NAME CHANGE:20031112
FORMER COMPANY:FORMER CONFORMED NAME:IDEC PHARMACEUTICALS CORP / DEDATE OF NAME CHANGE:19970530
DEFA14A1b79481defa14a.htmDEFA14A
defa14a
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
PROXY STATEMENT PURSUANT TO SECTION 14(a) OFTHE SECURITIES EXCHANGE ACT OF 1934
Filed by the Registrant Filed by a Party other than the Registrant oCheck the appropriate box:oPreliminary Proxy Statement
o Confidential, for Use of the Commission Only (as permitted by Rule14a-6(e)(2))
o Definitive Proxy Statement
o Definitive Additional Materials
Soliciting Material Pursuant to 240.14a-12
BIOGEN IDEC INC.
(Name of Registrant as Specified In Its Charter)
N.A.(Name of Person(s) Filing Proxy Statement, if other than the Registrant)
Payment of Filing Fee (Check the appropriate box):
No fee required.
o Fee computed on table below per Exchange Act Rules14a-6(i)(1) and 0-11.
(1) Title of each class of securities to which transaction applies:
(2) Aggregate number of securities to which transaction applies:
(3) Per unit price or other underlying value of transactioncomputed pursuant to Exchange Act Rule0-11 (set forth theamount on which the filing fee is calculated and state how itwas determined):
(4) Proposed maximum aggregate value of transaction:
(5) Total fee paid:
o Fee paid previously with preliminary materials.
o Check box if any part of the fee is offset as provided by Exchange Act Rule0-11(a)(2) and identify thefiling for which the offsetting fee was paid previously. Identify the previous filing by registrationstatement number, or the Form or Schedule and the date of its filing.
(1) Amount Previously Paid:
(2) Form, Schedule or Registration Statement No.:
(3) Filing Party:
(4) Date Filed:
Investor Presentation
February 17, 2010
This presentation includes forward-looking statements about:
our strategy for maximizing shareholder value
the ability to improve the benefit-risk profile of TYSABRI(r) and drive future growth
ongoing development initiatives and growth strategies for our marketed products
the anticipated development and timing of programs in our clinical pipeline and regulatory actions
These statements are based on our current beliefs and expectations and involve risks and uncertainties that could cause actual results todiffer materially from those which we expect. Important factors which could cause actual results to differ from our expectations and whichcould negatively impact our financial position and results of operations include our dependence on our three principal products, AVONEX(r),RITUXAN(r) and TYSABRI(r), the importance of market acceptance and successful sales growth of TYSABRI(r), uncertainty of success incommercializing other products, the occurrence of adverse safety events with our products, competitive pressures, changes in theavailability of reimbursement for our products, our dependence on collaborations over which we may not always have full control, failure toexecute our growth initiatives, failure to comply with government regulation and possible adverse impact of changes in such regulation,problems with our manufacturing processes and our reliance on third parties, charges and other costs relating to our properties, fluctuationsin our effective tax rate, our ability to attract and retain qualified personnel, the risks of doing business internationally, representation byactivist shareholders, our ability to protect our intellectual property rights and the cost of doing so, product liability claims, fluctuations in ouroperating results, credit and financial market conditions, the market, interest and credit risks associated with our portfolio of marketablesecurities, our level of indebtedness, environmental risks, aspects of our corporate governance and collaborations and the other risks anduncertainties that are described in the Risk Factors section of our annual report on Form 10-K and in other reports we file with the SEC.Forward-looking statements, like all statements in this presentation, speak only as of the date of this presentation (unless another date isindicated). Unless required by law, we do not undertake any obligation to publicly update any forward-looking statements, whether as aresult of new information, future events, or otherwise.
Biogen Idec and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders ofBiogen Idec in connection with the Company's 2010 annual meeting of stockholders. The names, affiliations and interests of suchindividuals may be found in Biogen Idec's Annual Report on Form 10-K for the year ended December 31, 2009 and its proxy statement forthe 2009 Annual Meeting, each of which are filed with the SEC. To the extent holdings of Biogen Idec securities have changed since suchdocuments were filed, such changes have been or will be reflected in Statements of Change in Ownership on Forms 3 and 4 filed with theSEC. Additional information regarding such individuals will be included in the Company's proxy statement in connection with theCompany's 2010 annual meeting of stockholders when such document is filed with the SEC. Biogen Idec files annual, quarterly and specialreports with the SEC. The proxy statements and other reports, when available, can be obtained free of charge at the SEC's web site atwww.sec.gov or from Biogen Idec at www.biogenidec.com. Biogen Idec stockholders are advised to read carefully the proxy statementrelating to the Company's 2010 annual meeting of stockholders and any other relevant documents filed by the Company with the SEC whenthey become available before making any voting or investment decision, because they will contain important information. The Company'sproxy statement will also be available for free by writing to Biogen Idec Inc., 14 Cambridge Center, Cambridge, MA 02142. In addition,copies of the proxy materials, including the Company's white proxy card, may be requested after they have been filed with the SEC from ourproxy solicitor, MacKenzie Partners, Inc., by toll-free telephone at 1-800-322-2885 or by e-mail at [email protected].
Forward Looking Statements and Important Information
2009 in Review
TYSABRI achieved 'blockbuster' status
Late stage MS pipeline advanced and expanded
Revenue grew despite headwinds
Operating margin reached nearly 40%
$1 billion stock buyback initiated
13
Disciplined Use ofCash
Extend AVONEX
and RITUXAN
through Lifecycle
Management
Accelerate
TYSABRI
Growth
Advance our Pipeline
SHAREHOLDER
VALUE
Key Levers to Maximize Shareholder Value
TYSABRI's Blockbuster Year 2003 2004 2005 2006 2007 FYE 2008 FYE 2009 TYSABRI U.S. Patients on Therapy 86 99 25 218 20100 24500 35 344 37600 48800 TYSABRI International Patients on Therapy 73 101 10 126 16900 23700 600 600 test
+30%
Patients on Therapy
+30% 2003 2004 2005 2006 2007 FYE 2008 FYE 2009 TYSABRI In Market U.S. Sales (in $ millions) 86 99 25 218 421.6 508.5 35 344 813 1059.2 TYSABRI In Market International Sales (in $ millions) 73 101 10 126 391.4 550.7
In-Market Revenue ($M)
= U.S.
= ROW
= TRIALS
Viral coat protein(VP1) variants
Regulatoryregion JC Virusvariants
Research to Reduce PML Risk and
Improve Outcomes
6
Management
Prediction and Prevention
Viral Factors
Patient Factors
NatalizumabRemoval
Stop DiseaseProgression
JC Virus Antibody Test
Prior Treatment WithImmunosuppressants
Natalizumab MOA
JCV-specific T-cellfunction
Plasma Exchange(PLEX)
Anti-JCV drugscreening
Mefloquineclinical trial
JC Virus Antibody Test
7
ELISA assay
JC virus antibody detected in 50% to60% of adults
All TYSABRI-treated patients whodeveloped PML, for whom sampleswere available prior to diagnosis(n=11), were anti-JCV antibodypositive
Additional evaluations are plannedto define the potential utility of theassay for PML risk stratification
Note: Two recent studies supporting JCV seroprevalence below 60% include: Prevalence estimate of 38% found by Kean, Rao, Wang,and Garcea (2009), "Seroepidemiology of human polyomaviruses." PLoS Pathog, 5(3):e1000363
Prevalence estimate of 58% found by Egli, Infanti, Dumoulin, Buser, Samaridis, Stebler, Gosert, and Hirsch, "Prevalence ofPolyomavirus BK and JC Infection and Replication in 400 Healthy Blood Donors." The Journal of Infectious Diseases 2009;199:837-846
Initiative Objective(s) Switching study vs. Copaxone(r) and Rebif(r) Reinforce efficacyDemonstrate benefit of switching earlyDemonstrate TYSABRI should be first choice switch therapy when you need more efficacy Geographic Expansion Expand market - increased footprint from 38 to 45 countries between 2008 and 2009. Potential growth in Asia, Latin America, Eastern Europe and Middle East Subcutaneous formulation Provide another dosing option for TYSABRI patients SPMS Indication Expand marketReinforce efficacy
Driving Future TYSABRI Growth
Note: Copaxone(r) is a registered trademark of Teva Pharmaceutical Industries Limited andRebif(r) is a registered trademark of EMD Serono, Inc. or its affiliates
AVONEX Franchise Durability 2009 2010+ Granted method of use patent through 2026FPI Phase 3 PEGylated interferon trialCHAMPIONS 10-year resultsCompleted Phase 2 enrollment in Ulcerative Colitis trial AutoinjectorTitrationUlcerative ColitisLong term efficacy data
Note: patent mentioned above is #7,588,755
Expanding the CD-20 Franchise 2009 2010+ PRIMA NHL 1st line maintenance resultsFPI Phase I subcutaneous formulation trialRITUXAN RA label expanded to include new claim for improvement in physical function and guidance on retreatment for TNF-IR patients Next generation molecules:GA-101 in OncologyOcrelizumab in Immunology
REACH and CLL8: relapsed and front line CLLANCA-Associated VasculitisRATE rapid infusion study
Psoriasis
Hemophilia B
Rheumatoid Arthritis
Crohn's Disease
2010 Pipeline
Daclizumab
Anti-LINGO
AVONEX
TYSABRI
Ocrelizumab
BG-12
BIIB014
Neublastin
RITUXAN
FUMADERM
Pain
Multiple Sclerosis
Multiple Sclerosis
Multiple Sclerosis
Multiple Sclerosis
Multiple Sclerosis
Parkinson's
MS
Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Solid Tumor
Solid Tumor
RITUXAN
Galiximab
Anti-Cripto-DM4
HSP90 Inhibitor
Volociximab
Anti-IGF-1R
Lumiliximab
NEUROLOGY
ONCOLOGY
Market
Phase 1
Phase 2
Phase 3
Pre-Clinical
Market
Phase 1
Phase 2
Phase 3
Pre-Clinical
Long Acting rFactor IX
Lixivaptan
Long Acting rFactor VIII
Hyponatremia
Solid
BART
AD
Multiple Sclerosis
PEGylated-IFNb1a
NHL
GA 101
Market
Phase 1
Phase 2
Phase 3
Pre-Clinical
Market
Phase 1
Phase 2
Phase 3
Pre-Clinical
Rheumatoid Arthritis
RA
BG-12
Anti-TWEAK
Ulcerative Colitis
AVONEX
RAF Inhibitor
Fampridine-PR
Multiple Sclerosis
Lixivaptan
ANCA Associated Vasculitis
RITUXAN
Chronic Lymphocytic Leukemia
RITUXAN
Solid Tumor
TYSABRI
Ocrelizumab
Rheumatoid Arthritis
Congestive Heart Failure
Solid
Anti-FcRn
Pemphigus
AD = Alzheimer's Disease, IBD = Irritable Bowel Disease
CLL
GA 101
Hemophilia A
Non-Hodgkin's Lymphoma
GSM
AD
EMERGING
IMMUNOLOGY
NEUROLOGY
TYSABRI
Multiple Myeloma
= Progress Since 2007
IBD
TNF-TWEAK Bispecific
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