Credit Suisse 7 th Annual European Large Cap Pharmaceutical Conference. November 6, 2007

Transcription

1 Credit Suisse 7 th Annual European Large Cap Pharmaceutical Conference November 6, 2007

2 Safe Harbor Statement This presentation contains forward-looking statements about Elan s financial condition, results of operations and business prospects that involve substantial risks and uncertainties. A list and description of these risks, uncertainties and other matters can be found in Elan s Annual Report on Form 20-F for the fiscal year ended December 31, 2006 and in its Reports of Foreign Issuer on Form 6-K filed with the SEC. Elan assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. -1-

3 Agenda 1. Strategy 2. Tysabri 3. Pipeline / Science 4. Elan Drug Technologies 5. Financial Results -2-

4 Strategy -3-

5 Our Objective Create the world s leading neuroscience-based biotechnology company within five years How do we define leading? Leading in terms of depth, breadth and discovery innovation within our science Leading in terms of our intellectual property Leading in terms of profitability, earnings growth and value creation -4-

6 Profitability, Growth and Value Creation Science + Intellectual Property focused in high value therapeutic areas (AD, MCI, Dementia, PD, MS) Science + Intellectual Property leveraged into other areas (autoimmune, oncology, cardiology) Financial/Tax Structure will drive incremental EPS vs. the vast majority of competitors and further enhance distinctive earnings growth and value creation for shareholders -5-

7 TYSABRI -6-

8 Tysabri for Multiple Sclerosis Approved for re-marketing in US and approved in EU in June 2006 Launched in several EU countries Significant unmet need ~1 million patients worldwide ~400,000 treated patients 200,000 to 250,000 of treated patients unsatisfied Focus for 2007 on making Tysabri widely available to appropriate MS patients Roll-out of TOUCH program in the US and efficacy message Roll out country by country in EU; align pricing and reimbursement -7-

9 AFFIRM (Study 1801); Efficacy Annualized Mean Relapse Rate Year One Year Two % 67 % Placebo N=315 Natalizumab N=627 Number of MS Lesions* Placebo N=315 Natalizumab N=627 At Year One 1.3 At Year Two % 92% * Mean Number. P < Placebo N=315 Natalizumab N=627 Placebo N=315 Natalizumab N=627-8-

10 AFFIRM (Study 1801): Risk of Disability Progression* 42% reduction in risk of disability progression versus placebo Proportion With Sustained Progression Hazard Ratio (HR)=0.58 Placebo 29% Natalizumab 17% Weeks * Progression defined as sustained change in EDSS over 3 months. P <

11 Additional Tysabri Efficacy and Safety Data Data presented at ECTRIMS on 29 th September 2006, AAN on 3 rd May 2007 and ECTRIMS on 13 th October 2007 Sustained effect on relapse rate up to 3 years; consistent with relapse rate seen in the 2 year AFFIRM study Significantly increases the proportion of disease-free patients; according to a post hoc analysis of AFFIRM study PLEX study suggests plasma exchange may be an effective means of accelerating the removal of Tysabri from the circulation No new reports of confirmed cases of PML as of mid-september First MS therapy to demonstrate improvements in quality of life measures Significant effects on cognitive function Boxed Warning: There is a prominent boxed warning in the label regarding the risk of PML. -10-

12 Total Worldwide Sales for MS: $6 Billion (2006) MS Market anticipated to double by 2011* Sources: Company Reports * Multiple Sclerosis: Worldwide Market Outlook to

13 Worldwide Initial Target Market for Tysabri MS Breakthrough / Poor Tolerability Stable 400K Treatment Stopped 100K -12-

14 MS Competitive Landscape Company Therapy Annual Cost Cost Per Avoided Relapse* Delivery Biogen Idec Avonex $20,163 $69,111 Weekly Injection Bayer AG Betaseron $20,989 $65,241 Every other day Injection Merck Serono Rebif $21,676 $75,785 3X weekly Injection Teva Copaxone $19,124 $73,601 Daily Injection Elan / Biogen Tysabri $28,400 $52,511 Monthly Infusion *Over a 2-year period when used as monotherapy for the treatment of relapsing forms of MS. Presented at the Academy of Managed Care Pharmacy Educational Conference in Chicago, October

15 Tysabri US Tysabri (as of end of September 2007) ~2,100 Doctors have enrolled patients ~10,500 patients on therapy Commercial focus on efficacy / benefit v. risk profile Tysabri EU ~5,500 patients on therapy NICE recommends TYSABRI for patients with highly active RRMS Now available in majority of European countries; available in remaining countries by year-end Clinical Trials ~1,000 patients on therapy Approximately 17,000 patients on Tysabri therapy worldwide -14-

16 TYSABRI Launch Status -15-

17 Elan s Tysabri MS Profit Contribution Based on Patient Numbers 1,600 1,400 Breakeven at 15,000 patients significant operating leverage Elan Operating Profit Current MS Products Tysabri contribution ($m) 1,200 1, % 8% 12% 16% 20% 24% 28% 32% % market share Every 1% Market Share Contributes ~ $50 M in Operating Profit for Elan -16-

18 Tysabri for Crohn s Disease FDA Advisory Committee Recommends Approval Committee voted 12-3 for approval of TYSABRI as a treatment for moderate-to-severe Crohn's disease patients who have failed or cannot tolerate available therapies. TOUCH risk minimization plan will be adapted for Crohn s disease indication FDA decision due by mid January 2008 EMEA decision on the appeal expected by the end of Q CHMP adopted a negative opinion on the marketing application for the use of natalizumab in patients with Crohn's disease. Elan and Biogen Idec applied for a re-examination of the negative opinion through the appeal procedure. -17-

19 Crohn s Disease Market Overview Patient Population: 1 Million WW CD Suffers ( 000) US Growing Market EU Approximately 800,000 Crohn s patients in the US & EU Treated by Specialists Crohn s patients are diagnosed and treated regularly by gastroenterologists These doctors can be addressed with a small sales force 11,000 practicing GIs in the US Less than 1,000 focused specialists High Unmet Need $3.0 $2.5 $2.0 $1.5 $1.0 $0.5 $0.0 US Sales ($B) Better treatments are needed, especially for moderate to severe Crohn s patients Current therapies still have limitations Sources: Decision Resources, Pharma Prescriber, Remicade Label, AMA.org -18-

20 Additional Indications Systematic Evaluation Process Oncology Other Autoimmune UC -19-

21 Pipeline -20-

22 Science Driven Pipeline Preclinical Regulatory Marketed MS Crohn s Alzheimer s Alzheimer s Alzheimer s Alzheimer s Alzheimer s Alzheimer s MS Alzheimer s Alzheimer s Oncology Crohn s Alzheimer s Parkinson s MS Various Tysabri Tysabri Bapineuzumab Gamma (external) Bapineuzumab Sub Q ACC-001 ELND-005 AAB-002 ELND-002 Gamma (internal) Beta Secretase Tysabri ELND-004 AD Discovery PD Discovery MS Discovery Aptamer Technology -21-

23 Alzheimer s Pathology Elan s Approach Secretase Inhibitors Amyloid Protein Beta Secretase Aβ Gamma Secretase ELND-005 Beta Amyloid Peptide Aβ AIP Aβ Beta Amyloid Fibrils -22- β-amyloid Deposits

24 Elan Alzheimer s Programs Eliminate Existing Aβ Immunotherapy Programs Bapineuzumab Bapineuzumab SubQ ACC-001 AAB-002 Prevent Production of Aβ Secretase Inhibitors BACE Gamma - internal Gamma external* Prevent Aggregation of Aβ Anti-aggregation ELND-005 (AZD-103) In collaboration with Wyeth *Co-promotion option with Eli Lilly In collaboration with Transition Therapeutics -23-

25 AN Key Learnings from Available Clinical Data Removes pathology Improves cognition Improves quality of life Reduces dependency on caregivers -24-

26 Bapineuzumab Reduces Plaque Burden in Mice Control antibody Bapineuzumab -25- Buttini et al, J. Neuroscience Oct 2005

27 Memory Improvement in Patients After 4 Months of Single Dose of Bapineuzumab 2.5 p < 0.05 Clinical worsening Change from Baseline MMSE p < 0.15 Placebo (n=8) 0.5 mg/kg (n=6) 1.5 mg/kg (n=6) 5 mg/kg (n=11) Geneva/Springfield AD Symposium 2006

28 Bapineuzumab Current Status Phase 2 Studies ongoing Multiple Ascending Dose (240 patients) PET Study (30 patients) Blinded Regulatory Status Fast tracked 2006 Subpart E Opportunity Initiate Phase 3 in Q

29 Bapineuzumab Pathway to Phase 3 The Big Picture Pre-clinical Reverses Pathology Improves Memory AN-1792 Phase 2-1 year Improves Memory Improves Cognition Improves Quality of Life Phase years Improves Cognition Improves Quality of Life Phase 3 Preclinical Reverses Pathology Improves Memory Phase I Improves memory Bapineuzumab -28- Phase 2 Interim look May 2007

30 Bapineuzumab Summary Phase 2 ongoing Final data mid-2008 Initiate Phase 3 in 4Q 2007 US and EU Subcutaneous formulation in Phase 1 Initiate Phase 2 in 1H

31 ACC-001: Reducing CNS Inflammation Aβ42 CRM AN-1792 ACC

32 ACC-001 Current Status Phase 2 initiated Randomized, double-blind, placebo controlled Conducted in US and EU N=228 4 ascending doses -31-

33 ELND-005 (AZD-103) Aβ Aβ Aβ aggregates into neurotoxic oligomers -32-

34 ELND-005 Prevents Plaque Build-Up Increases Survival in AD Animal Model Plaque Removal Survival p=0.02 % amyloid * Cumulative Survival Untreated Treated 0.4 Untreated Treated Time -33- McLaurin et al Nature Medicine June 2006

35 ELND-005 Current Status Phase I studies completed evaluating ELND-005 (AZD-103) in healthy volunteers Approximately 110 subjects exposed to ELND-005 ELND-005 was safe and well tolerated at all doses No severe or serious adverse events were observed ELND-005/AZD-103 was shown to be orally bioavailable, crossed the blood-brain barrier and achieved levels in the human brain and CSF that were shown to be effective in animal models for Alzheimer's disease Fast track status granted April 2007 Initiate Phase 2 late 2007 / early

36 Elan Drug Technologies -35-

37 Drug Technology Expertise Broad range of technology solutions to optimize compounds, including NanoCrystal Technology for poorly water-soluble compounds Significant opportunities with NanoCrystal Technology Oral Controlled Release (OCR) Technology Platform Proven record in development, scale-up manufacture and registration of drug products More than 30 developed, manufactured and marketed products worldwide Large-scale, commercial manufacturing capability ~270,000 sq ft of facilities in US and Ireland Over 37 years of experience in drug delivery/ drug optimization Comprehensive patent portfolio and intellectual property position in drug technology Major Marketed products Afeditab Avinza Cardizem CD Emend Focalin XR Herbesser R Megace ES Rapamune Tablets Ritalin LA Theodur TriCor Verelan Verelan PM Zanaflex capsules Over 1,000 patent/patent applications around key technologies -36-

38 EDT Selected Growth Drivers Sponsor Product Indication Phase In-market potential I N - M A R K E T Abbott/Solvay TriCor /Lipanthyl Cholesterol lowering Marketed $1.2bn King Skelaxin Muscle spasticity Marketed $400m Novartis Ritalin LA/Focalin XR ADHD Marketed $300m King Avinza Chronic pain Marketed $200m Par Megace ES Anorexia & Cachexia Marketed $100m Acorda Zanaflex Capsules Muscle spasticity Marketed $80m 2008 Jazz Luvox CR Social Anxiety Disorder (SAD) Obsessive Compulsive Disorder (OCD) Filed $ m J&J Paliperidone Palmitate Schizophrenia Filed $1bn MAP Budesonide Asthma III $ m Acorda Fampridine MS III $ m 2010 Solvay ZOLIP Cholesterol combination III $500m Entremed Panzem Oncology II $ m Royalty rates mid single digits to high-teens % -37-

39 Financial Results -38-

40 FY 2006 Results Net losses down 30% and adjusted EBITDA losses down 58% Revenue up 14% Operating expenses down 9% (exclusion of stock option expense) Inclusion of $47m stock based compensation Tysabri WW revenues of $38m Elan recorded $17m of Tysabri revenue EBITDA losses down 38% Results significantly ahead of prior guidance -39-

41 Nine Months Ended September 30: 2006A v 2007A Adjusted EBITDA losses 67% lower Revenue up 37% driven by Tysabri Gross profit % lower due to Tysabri collaboration accounting Operating expenses increased 2% mainly due to higher Tysabri spend WW Tysabri revenues of $214m ($141m recorded by Elan) Over 17,000 patients on therapy in MS, passing the break-even point Targeting 100,000 patients by end 2010 ROB EBITDA profitable Net loss higher due to other charges $99m charges in 2007 (debt retirement, Maxipime/Azactam impairment, west-coast restructuring) $40m gain in H1 06 (sale of Prialt EU) -40-

42 Analysis of Revenues YTD

43 Analysis of Operating Expenses YTD

44 Analysis of EBITDA Loss YTD

45 Guidance (revised for generic competitor to Maxipime) Guidance 2006 Actual 2006 Guidance 2007 Revenue (excl Tysabri) $500M+ $543M Approach $500M Operating expenses $ M $579M < $600M EBITDA loss $ M $91M < $50M Path to profitability established Expect 100,000 Patients on Tysabri by YE

46 Debt Management (61%) (In $ bn) (67%) Dec 2001 Sept 2007 Dec 2001 Sept 2007 Total Debt Net Debt -45-

47 Debt Management -46-

48 Debt Management September -47-

49 Capitalization $MM % 7.75% Notes (2011) / 8 % Notes (2013) FRNS (2011/2013) Total debt 1, Equity Market Cap ($23/shr) 10, , % Net Debt 950 Net Debt/TEV 7.5% Modest Debt / TEV -48-

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