Alkermes Plc · NASDAQ:ALKS
Alkermes — Investor Day (July 2011)
108 slides from Alkermes's investor day presentation, Jul 18, 2011
Slide 1: Alkermes plc: Deep Dive
Rebecca Peterson Vice President, Corporate Communications Alkermes plc: Deep Dive July 18, 2011
Slide 2: Forward-looking statements
Information presented and discussed today will constitute forward-looking statements, including but not limited to statements concerning the likelihood that the merger with EDT is consummated and the timing of such consummation; future financial and operating performance, business plans or prospects
Slide 3: Important Additional Information and Where to Find It
Important Additional Information and Where to Find It This communication does not constitute an offer to sell, or the solicitation of an offer to sell, or the solicitation of an offer to subscribe for or buy, any securities nor shall there be any sale, issuance or transfer of securities in any juris
Slide 4: Analyst and Investor Day Agenda
Analyst and Investor Day Agenda The Creation of Alkermes plc Richard Pops, CEO Recent News: Pipeline and Product Advances Elliot Ehrich, M.D., CMO EDT: Business Model, Product Successes and Revenue Streams Shane Cooke, Head of EDT Modeling Alkermes plc: What You Need to Know James Frates, CFO Q&A Ri
Slide 5: COPYRIGHT (c) 2011 ALKERMES, INC. www.alkermes.com
COPYRIGHT (c) 2011 ALKERMES, INC. www.alkermes.com
Slide 6: The Creation of Alkermes plc
Richard Pops Chief Executive Officer The Creation of Alkermes plc July 18, 2011
Slide 7: The deal is financially transformative
The deal is financially transformative The growth will be driven by a portfolio of products, including 5 key commercial products that are leaders in their classes with long expected periods of exclusivity The growth will continue and accelerate through a pipeline of new product candidates that origi
Slide 8: Moving from money losing to money making
The deal is financially transformative: We move from money losing to money making Revenue base immediately becomes $450 million And we will grow from there, with projected long-term double-digit growth in revenues and Adjusted EBITDA 8
Slide 9: Growth driven by a portfolio of five key commercial products
The growth will be driven by a portfolio of products, including 5 key commercial products that are leaders in their classes with long expected periods of exclusivity: RISPERDAL(r) CONSTA(r) and INVEGA(r) SUSTENNA(r): Together form a pure play on the growth of the long-acting atypical market AMPYRA(r
Slide 10: Growth accelerated through a pipeline of new product candidates
The growth will continue and accelerate through a pipeline of new product candidates that originates from an organization with proven innovation, development and manufacturing capabilities ALKS 9070: NCE for schizophrenia - Human PK complete ALKS 37: NCE for OIC - Human POC complete ALKS 5461: NCE f
Slide 11: Highly efficient corporate structure
As we become larger and more profitable, we will realize increasing benefits from a highly efficient corporate structure Alkermes plc will be an Irish company, headquartered in Dublin with an international presence We will have operational flexibility to access expertise and financial efficiencies i
Slide 12: One of the most differentiated biopharmaceutical companies
Finally, we will emerge as one of the most differentiated and unique companies in the biopharmaceutical industry A profitable, rapidly growing company with a late stage pipeline and proven expertise in the creation and development of innovative medicines, with a focus in CNS There are few, if any, d
Slide 13: $2-5B Market Cap Biotech Companies
$2-5B Market Cap Biotech Cos. Company Market Cap ($B) InterMune Inc. 2.0 Cubist Pharmaceuticals Inc. 2.2 Onyx Pharmaceuticals Inc. 2.2 Salix Pharmaceuticals Ltd. 2.3 Seattle Genetics Inc. 2.4 Incyte Corp. 2.4 Ipsen Group 3.0 BioMarin Pharmaceutical Inc. 3.1 United Therapeutics Corp. 3.2 Pharmasset I
Slide 14: $5B+ Market Cap Companies
$5B+ Market Cap Cos. Company Market Cap ($B) Regeneron Pharmaceuticals Inc. 5.1 Dendreon Corp. 6.0 Actelion Ltd. 6.6 Elan Corp. plc 7.0 UCB Group 8.0 Alexion Pharmaceuticals Inc. 8.7 Vertex Pharmaceuticals Inc. 10.5 Valeant Pharmaceuticals International Inc. 15.6 Shire plc 17.6 Biogen Idec Inc. 26.2
Slide 15: COPYRIGHT (c) 2011 ALKERMES, INC. www.alkermes.com
COPYRIGHT (c) 2011 ALKERMES, INC. www.alkermes.com
Slide 16: Recent News: Pipeline and Product Advances
Elliot Ehrich, M.D. Chief Medical Officer Recent News: Pipeline and Product Advances July 18, 2011
Slide 17: Portfolio in Motion: Progress Since Merger Announcement
Portfolio in Motion: Progress Since Merger Announcement RISPERDAL(r) CONSTA(r): Patent extension in U.S. into 2023 VIVITROL(r): Approval for opioid dependence in Russia; patent extension in U.S. into 2029 BYDUREON(tm): Approval / launch in EU; announced clean tQT data; presented positive exenatide o
Slide 18: Alkermes: VIVITROL
Alkermes: VIVITROL®
Slide 19: Opioid Dependence Crisis
Opioid Dependence Crisis The Prescription Drug Epidemic Prescription drug abuse is now worse than the crack epidemic. Oxycontin. Xanax. Pill Mills. Doctor shopping. Surge in Number of Americans Treated for Prescription Painkiller Abuse Fighting the opiate crisis in Mass. A Wave of Addiction and Crim
Slide 20: Real Interest by Medical Community Demonstrated by Volume of VIVITROL Trials
Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland Extended-Release Naltrexone for Opioid Relapse Prevention Following Release from Jail Real Interest by Medical Community Demonstrated by Volume of VIVITROL(r) Trials Improved Strategies for Outpatient Opioid Detoxification VI
Slide 21: VIVITROL Use in Criminal Justice System
VIVITROL(r) Use in Criminal Justice System 21
Slide 22: VIVITROL Use in Criminal Justice System
VIVITROL(r) Use in Criminal Justice System 22 "On the principal outcome of interest, the mean annualized rearrest rate, control subjects were more than three times more likely to be rearrested within a year than subjects who also received treatment with XR-NTX. This represents a relative risk reduct
Slide 23: VICTORY Study Designed to Demonstrate Health Economics and Efficacy
VICTORY Study Designed to Demonstrate Health Economics and Efficacy VIVITROL's Cost and Treatment Outcomes RegistrY Observational, open-label, multi-center study of ~500 opioid dependent patients treated with VIVITROL(r) Objectives Measure outcomes from real-world use of VIVITROL: clinical, health e
Slide 24: Alkermes: BYDUREON
Alkermes: BYDUREON™
Slide 25: BYDUREON: Progress on Multiple Fronts
BYDUREON(tm): Progress on Multiple Fronts Approved in EU Country-by-country launch beginning in Q3 CY 2011 Launched in UK in July Filed with Japan regulatory authorities in Q2 CY 2011 U.S. regulatory status Clean data from tQT study announced AMLN to refile with FDA in Q3 CY 2011 Exenatide once mont
Slide 26: BYDUREON tQT Study - No Prolongation
BYDUREON(tm) tQT Study - No Prolongation Study designed in accordance with existing guidelines and FDA consultation Exenatide at normal and supratherapeutic concentrations Result: No increase in QTc interval Multiple correction methodologies assessed No correlation between exenatide concentration an
Slide 27: Exenatide Lifecycle Plan in Action
Molecule Product Frequency Reconstitute Device Exenatide BYETTA(r) 2X Daily No Single-chamber pen Exenatide BYDUREON(tm) Weekly Yes CDK† Exenatide BYDUREON pen Weekly Yes Dual-chamber pen Exenatide Weekly Suspension Weekly No Single-chamber pen Exenatide Monthly Suspension Monthly No Single-chamber
Slide 28: Once-Monthly Exenatide Suspension Clinical Profile Similar to BYDUREON
Once-Monthly Exenatide Suspension Exhibited a Clinical Profile Similar to BYDUREON(tm) Over 20 Weeks MacConell et al., ADA Scientific Sessions 2011 Time (Weeks) 28 0 4 8 12 16 20 6.5 7.0 7.5 8.0 8.5 9.0 7.3% 6.9% Mean A1c (%) 7.1% 2 mg Weekly (N=29, BL=8.6%) 5 mg Monthly (N=26, BL=8.4%) 8 mg Monthly
Slide 29: Alkermes: ALKS 9070
Alkermes ALKS 9070
Slide 30: ALKS 9070: Once-Monthly Treatment for Schizophrenia
ALKS 9070: Once-Monthly Treatment for Schizophrenia Proprietary, once-monthly, injectable, extended-release atypical antipsychotic Leverages proprietary LinkeRx(tm) technology Converts in vivo to aripiprazole Product presentation No reconstitution required Non-refrigerated Small needle gauge Composi
Slide 31: ALKS 9070 Engineered to Optimize Absorption and Metabolic Properties
Aripiprazole Linker Tail ALKS 9070 Engineered to Optimize Absorption and Other Metabolic Properties Dissolution Cleavage ALKS 9070 at injection site Aripiprazole Linker Tail 31
Slide 32: ALKS 9070 Engineered to Optimize Absorption and Metabolic Properties
Dissolution Cleavage Aripiprazole in circulation ALKS 9070 at injection site ALKS 9070 Engineered to Optimize Absorption and Other Metabolic Properties 32
Slide 33: ALKS 9070: Phase 1b Study Design and Objectives
ALKS 9070: Phase 1b Study Design and Objectives Phase 1b study N=32 patients with schizophrenia Multiple dose levels (150 mg, 300 mg, 400 mg) Study objectives Duration of release Predictability Injection site tolerability ? ? ? 33
Slide 34: Sustained Aripiprazole Plasma Concentrations from Single IM Dose
Sustained, Clinically Relevant Aripiprazole Plasma Concentrations from Single IM Dose ALKS 9070 150 mg ALKS 9070 300 mg ALKS 9070 400 mg 34
Slide 35: ALKS 9070 Dosing
ALKS 9070 Dosing 35 ALKS 9070 30 Days ALKS 9070 30 Days ALKS 9070 30 Days Daily Aripiprazole
Slide 36: Steady State Pharmacokinetics of ALKS 9070
Steady State Pharmacokinetics of ALKS 9070 Months 300 200 150 100 0 50 Aripiprazole Concentration (ng/ml) 250 In-house modeled data 36
Slide 37: ALKS 9070: Pivotal Program Next Steps
ALKS 9070: Pivotal Program Next Steps Clear clinical path enabled by prior long-acting atypical antipsychotics End of Phase 2 meeting with FDA in H2 CY 2011 Phase 3 study design in patients with schizophrenia Conventional efficacy measures including PANSS score improvement and BPRS Safety and tolera
Slide 38: ALKS 37
(Alkermes ALKS 37 7, ‘COPYRIGHT © 2011 ALKERMES, INC.
Slide 39: ALKS 37: Opioid-Induced Constipation (OIC)
ALKS 37: Opioid-Induced Constipation (OIC) Novel, oral opioid receptor modulator targeting GI tract with limited systemic exposure Unmet medical need Estimated 266 million prescriptions for opioids written in U.S. in 20101 Up to 90% of patients treated with opioids experience constipation2 IMS Healt
Slide 40: ALKS 37: Novel, Oral Opioid Receptor Modulator
ALKS 37: Novel, Oral Opioid Receptor Modulator Desired Attributes ALKS 37 Selective Mu Opioid Receptor Antagonist GI Targeting Low Systemic Exposure Peripherally-Restricted ? ? ? 40 ?
Slide 41: ALKS 37 Targets Gastrointestinal Tract
ALKS 37 Targets Gastrointestinal Tract 41
Slide 42: ALKS 37 Significantly Improves Bowel Function
ALKS 37 Significantly Improves Bowel Function p=0.006 * Weekly SBM (change from baseline) p=0.007 * Weekly CSBM (change from baseline) 42 Phase 2 data of ALKS 37 presented at Digestive Disease Week 2011
Slide 43: ALKS 37 Phase 2b Definitive Dose-Ranging Study
ALKS 37 Phase 2b Definitive Dose-Ranging Study Designed to evaluate safety, tolerability and efficacy of ALKS 37 for treatment of OIC 150 patients with OIC during treatment with opioids for chronic, non-cancer pain Randomized to one of four dose levels of once-daily, oral ALKS 37 for four treatment
Slide 44: ALKS 5461: Functional Kappa Antagonist
ALKS 5461: Functional Kappa Antagonist 44
Slide 45: Kappa Antagonists Have Potential in Treatment of Depression
Kappa Antagonists Have Potential in Treatment of Depression 45
Slide 46: ALKS 5461: A Novel, Functional Kappa Antagonist
ALKS 5461: A Novel, Functional Kappa Antagonist Buprenorphine ALKS 33 + - Kappa Mu 46
Slide 47: ALKS 5461: A Novel, Functional Kappa Antagonist
ALKS 5461: A Novel, Functional Kappa Antagonist Buprenorphine ALKS 33 + - Kappa Mu 47
Slide 48: ALKS 5461: A Novel, Functional Kappa Antagonist
ALKS 5461: A Novel, Functional Kappa Antagonist Buprenorphine ALKS 33 ALKS 5461 + - Kappa Mu 48
Slide 49: ALKS 5461: Treatment-Resistant Depression
ALKS 5461: Treatment-Resistant Depression Phase 1b clinical study underway Multi-center, placebo-controlled, multi-dose study designed to evaluate safety and tolerability of ALKS 5461 in 32 patients with TRD Range of doses, administered in two different ratios of ALKS 33 and buprenorphine components
Slide 50: ALKS 5461: Phase 1b Study for Cocaine Addiction Underway
ALKS 5461: Phase 1b Study for Cocaine Addiction Underway; Funded by NIDA 50
Slide 51: Dynamic Portfolio with CNS Focus
BYDUREON(tm) (Type 2 Diabetes) ALKS 37 (Opioid-Induced Constipation) Gastrointestinal Endocrinology ZOHYDRO(tm) (Pain) Meloxicam IV (Pain) Dynamic Portfolio with CNS Focus VIVITROL(r) (Opioid Dependence) ALKS 5461 (Cocaine Addiction) INVEGA(r) SUSTENNA(r) 3-month (Schizophrenia) ALKS 9070 (Schizophr
Slide 52: R&D Strategy: Fast Answers Driven by Data
R&D Strategy: Fast Answers Driven by Data Pursue new and innovative products based on established pharmacology Portfolio focus leverages expertise in CNS Disciplined portfolio management process driven by data Programs designed to get answers fast and early in the development phase Ph. 1/2 Late-Phas
Slide 53: COPYRIGHT (c) 2011 ALKERMES, INC. www.alkermes.com
COPYRIGHT (c) 2011 ALKERMES, INC. www.alkermes.com
Slide 54: EDT: Business Model, Product Successes and Revenue Streams
Shane Cooke Head of Elan Drug Technologies (EDT) Business Model, Product Successes and Revenue Streams July 18, 2011
Slide 55: Elan Drug Technologies: Who We Are
Elan Drug Technologies: Who We Are 55 Develop and manufacture innovative pharmaceutical products that deliver clinically meaningful benefits to patients, leveraging extensive experience and proprietary drug technologies.
Slide 56: Elan Drug Technologies Snapshot
Elan Drug Technologies Snapshot Pipeline Commercial Diversified royalty and manufacturing revenues from 21 marketed products Key growth drivers: AMPYRA(r), INVEGA(r) SUSTENNA(r) All products commercialized by licensees Proprietary and partnered pipeline of 11 clinical programs Meloxicam IV, Megestro
Slide 57: Innovator with Solid Track Record
Innovator with Solid Track Record 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2009 INVEGA(r) SUSTENNA(r) launched 2008 LUVOX CR(r) launched 2011 2010 AMPYRA(r) launched 36 Products Approved 2011 FAMPYRA(r) conditional EU marketing authorization XEPLION(r) launched 57 2000 - 2007 TRICOR(r)
Slide 58: EDT Business Model Transitioning
EDT Business Model Transitioning: Creating Pipeline Through Technology Platforms Continued profitable growth underpinned by product development capabilities and technology platforms Focus shifted to internal pipeline opportunities to capture greater share of the revenue New / Improved Medications Te
Slide 59: EDT Cumulative 5-yr EBITDA Contribution
EDT Cumulative 5-yr EBITDA Contribution $M 2006 2007 2008 2009 2010 Diversified Portfolio, Generating Over $500M Cash Flow in Last 5 Years Near-term revenue growth Recent launches in U.S. of AMPYRA(r) and INVEGA(r) SUSTENNA(r) Approval in EU of FAMPYRA(r) and XEPLION(r) Pipeline Late-stage proprieta
Slide 60: Stable Cost Base: Significant Operating Leverage
Stable Cost Base: Significant Operating Leverage Proven track record of expense management Leveraging stable cost structure Base manufacturing infrastructure with capacity for expansion Disciplined investment in proprietary products Driving $20 million in deal synergies King of Prussia, PA site cons
Slide 61: Marketed Products & Operations
Marketed Products & Operations 61
Slide 62: AMPYRA / FAMPYRA
Patient model 2.5 million MS patients WW 60-70% of MS patients experience walking disability Response rate 35-45% in clinical trials Contraindicated in patients with renal impairment / seizures (~5% population) Administration Oral BID 12-hr release, utilizing MXDAS(r) OCR technology Peak sales Analy
Slide 63: INVEGA SUSTENNA / XEPLION
Patient model Over 5 million patients treated for schizophrenia in U.S. and EU Long-acting depot treatment U.S. <2% EU <5% Depot treatments expanding 14-15% per annum Administration Once-monthly injection Using NanoCrystal technology Peak sales Analyst estimates $800-1,400 million Economics Mid-to-h
Slide 64: Diversified Revenues - Mature Products Contribution
Diversified Revenues - Mature Products Contribution Anticipated competition reduces $187 million in revenue from mature products to approximately $80 million in 5 years 64 Broad portfolio of 21 products $187 million relating to mature products Royalties Manufacturing Different stages in lifecycle an
Slide 65: Diversified Revenues - Mature Products Overview
Diversified Revenues - Mature Products Overview Products FY 2011 Rev(1) (2) Indication Licensee In-Market Sales Calendar 2010(3) IP Information and Anticipated Impact $M $M TRICOR(r) 145 54.6 Cholesterol Abbott 1,582 Par IV settled; mid-2012 RITALIN LA(r) / FOCALIN(r) XR 32.8 ADHD Novartis 464 Par I
Slide 66: EDT Development & Manufacturing Services
Athlone, Ireland Dedicated cGMP facility NanoCrystal(r) and OCR* solid oral dosage development and manufacturing FDA and EMA registered Located on 40 acres / 420,000 sq ft Capacity to manufacture up to 2B units per year plus Fill Finish facility Revenue Driver: EDT Development & Manufacturing Servic
Slide 67: EDT Pipeline
Alkermes EDT Pipeline
Slide 68: EDT Pipeline - Proprietary & Client Programs
EDT Pipeline - Proprietary & Client Programs Compound Compound Phase Indication Sponsor Economics Megestrol EU Megestrol EU Filed Cachexia EDT 100% ZOHYDRO(tm) ZOHYDRO(tm) P3 Pain Zogenix Double-digit % LYXUMIA(r) LYXUMIA(r) P3 Type 2 Diabetes Zealand Low single-digit Meloxicam IV Meloxicam IV P2b P
Slide 69: Meloxicam IV - Key Feature: 12-24 hr Coverage
Meloxicam IV - Key Feature: 12-24 hr Coverage >70 million surgical procedures in the U.S. 39 million in-patient surgeries (>24-hour hospital stay) 31 million ambulatory/outpatient surgeries Standard of care primarily injectable opioids (IV morphine) alone or in combination with generic IV-NSAID* (ke
Slide 70: ZOHYDRO
ZOHYDRO(tm) (previously ZX002) Oral controlled-release hydrocodone bitartrate Chronic pain BID Multiple strengths (10-50 mg) EDT's SODAS(r) Technology First single-agent hydrocodone product Product concept from EDT Addresses acetaminophen-related liver toxicity concerns $3.1 billion U.S. annual sale
Slide 71: Conclusion
Alkermes Conclusion
Slide 72: EDT: Proven Business Operations & Drug Innovation
EDT: Proven Business Operations & Drug Innovation Proven ability to develop market-leading, high-growth products AMPYRA(r), AVINZA(r), INVEGA(r) SUSTENNA(r), NAPRELAN(r), RITALIN LA(r) / FOCALIN(r) XR, TRICOR(r) 145 and VERELAN(r) PM Portfolio approach leads to sustainable, high-margin growth busine
Slide 73: www.alkermes.com COPYRIGHT (c) 2011 ALKERMES, INC.
www.alkermes.com COPYRIGHT (c) 2011 ALKERMES, INC.
Slide 74: Modeling Alkermes plc
James Frates Chief Financial Officer Modeling Alkermes plc July 18, 2011
Slide 75: Elements of Modeling Alkermes plc
RISPERDAL(r) CONSTA(r) INVEGA(r) SUSTENNA(r) VIVITROL(r) AMPYRA(r) BYDUREON(tm) New Pipeline Other Revenues Taxes Revenues Interest Income/Expense Adjusted EBITDA Operating Expenses Revenues Elements of Modeling Alkermes plc 75
Slide 76: Elements of Modeling Alkermes plc
GAAP Net Earnings Taxes Revenues Interest Income/Expense Adjusted EBITDA Operating Expenses Operating Expenses Elements of Modeling Alkermes plc 76 COGS R&D SG&A Amortization of Intangibles
Slide 77: Elements of Modeling Alkermes plc
Taxes Revenues Interest Income/Expense Adjusted EBITDA Operating Expenses Interest Income/Expense Elements of Modeling Alkermes plc 77 Taxes
Slide 78: Elements of Modeling Alkermes plc
GAAP Net Earnings Taxes Revenues Interest Income/Expense Adjusted EBITDA Operating Expenses Revenues Operating Expenses Interest Income/Expense Elements of Modeling Alkermes plc 78 Taxes
Slide 79: Elements of Modeling Alkermes plc: Adjusted EBITDA
EBITDA Excluding: Share-based compensation expense One-off items (e.g. transaction expenses) Taxes Revenues Interest Income/Expense Adjusted EBITDA Operating Expenses Adjusted EBITDA Elements of Modeling Alkermes plc 79
Slide 80: Adjusted EBITDA Margin Expansion
Adjusted EBITDA Margin Expansion 80 FY 2012 FY 2015 Revenues Cash Expenses $ Single-digit revenue growth $460-480 million Adjusted EBITDA margins of 15-20% $70-90 million Double-digit revenue growth Adjusted EBITDA margins of 30-35% Pro Forma FY 2012 Pro Forma FY 2013 & Beyond
Slide 81: Elements of Modeling Alkermes plc
Taxes Revenues Interest Income/Expense Adjusted EBITDA Operating Expenses Revenues Elements of Modeling Alkermes plc COGS R&D SG&A Amortization of Intangibles GAAP Net Earnings RISPERDAL(r) CONSTA(r) INVEGA(r) SUSTENNA(r) VIVITROL(r) AMPYRA(r) BYDUREON(tm) New Pipeline Other Revenues 81
Slide 82: RISPERDAL CONSTA and INVEGA SUSTENNA: Growing the Long-Acting Atypical Class
RISPERDAL(r) CONSTA(r) and INVEGA(r) SUSTENNA(r): Growing the Long-Acting Atypical Class Growing the Long-Acting Atypical Class Growing the Long-Acting Atypical Class Source: Estimates based on First Call reports (as of 6/3/11) U.S. market experience: INVEGA SUSTENNA is growing the class +16% in FY
Slide 83: Momentum in U.S. Long-Acting Atypical Class
Momentum in U.S. Long-Acting Atypical Class 83 Net Sales (Millions) +16% +16%
Slide 84: VIVITROL: Opioid Dependence Launch Underway
VIVITROL(r): Opioid Dependence Launch Underway 35% unit growth FY 2010 to FY 2011 Opioid dependence indication expected to significantly accelerate growth Q1 FY 2012 net sales of $9.7 million Proprietary product marketed by Alkermes U.S. sales force Patent protection through 2029 in the U.S. Opioid
Slide 85: Modest Patient Penetration Drives Significant Market Opportunity
1.6 Million Opioid Dependent Adults in U.S.1 1.2 Million Patients Seeking Treatment1 ~900,000 Patients Prescribed Rx2 Modest Patient Penetration Drives Significant Market Opportunity SAMHSA, Office of Applied Studies, National Survey on Drug Use and Health, 2009 Alkermes projection using SDI, Propri
Slide 86: AMPYRA: Growth Opportunity
Actual Sales First Call Estimate Range AMPYRA(r): Growth Opportunity Launched by Acorda in U.S. in 2010 Anticipated EU approval summer 2011 (partnered with Biogen Idec) 18% combined manufacturing and royalty rate Patent protection into 2026 7-year orphan drug exclusivity in the U.S. 10-year regulato
Slide 87: BYDUREON: Entering Commercial Phase
BYDUREON(tm): Entering Commercial Phase Approved in EU in June 2011 Launched in UK July 2011; triggers $7 million milestone to Alkermes Planned U.S. resubmission Q3 CY 2011 tQT data announced July 2011 8% royalty rate worldwide Patent life into 2025 in U.S.; 2024 in EU 87 BYDUREON WW Net Sales * Sou
Slide 88: Diabetes Market: Favorable Dynamics
Diabetes Market: Favorable Dynamics Source: IMS Health $34.6 billion worldwide diabetes market in CY 2010 GLP-1s represent significant growth opportunity within worldwide diabetes market $1.1 billion in CY 2010 sales VICTOZA (r) (daily GLP-1) U.S. sales of $263 million in first year of launch; world
Slide 89: Top Products Drive the Business
Top 5 Products Drive the Business RISPERDAL(r) CONSTA(r) INVEGA(r) SUSTENNA(r) AMPYRA(r) VIVITROL(r) BYDUREON(tm) 89
Slide 90: Top Products Drive the Business
Top 5 Products Drive the Business Contract Mfg Meloxicam IV Megestrol Morphine EU ZOHYDRO(tm) ALKS 37 ALKS 9070 ALKS 5461 RISPERDAL(r) CONSTA(r) INVEGA(r) SUSTENNA(r) AMPYRA(r) VIVITROL(r) BYDUREON(tm) 90
Slide 91: Top Products Drive the Business
Top 5 Products Drive the Business Contract Mfg Meloxicam IV Megestrol Morphine EU ZOHYDRO(tm) ALKS 37 ALKS 9070 ALKS 5461 RISPERDAL(r) CONSTA(r) INVEGA(r) SUSTENNA(r) AMPYRA(r) VIVITROL(r) BYDUREON(tm) 91
Slide 92: Top Products Drive the Business
Top 5 Products Drive the Business Contract Mfg Meloxicam IV Megestrol Morphine EU ZOHYDRO(tm) ALKS 37 ALKS 9070 ALKS 5461 RISPERDAL(r) CONSTA (r) INVEGA(r) SUSTENNA(r) AMPYRA(r) VIVITROL(r) BYDUREON(tm) ~$450M Double-digit revenue growth FY 2013 forward 92
Slide 93: Alkermes plc Portfolio Enables Growth
Pro Forma FY 2011 of $450 million Alkermes plc Portfolio Enables Growth 93
Slide 94: Alkermes plc Portfolio Enables Growth
Alkermes plc Portfolio Enables Growth 94
Slide 95: Alkermes plc Portfolio Enables Growth
Alkermes plc Portfolio Enables Growth 95
Slide 96: Alkermes plc Portfolio Enables Growth
Alkermes plc Portfolio Enables Growth 96
Slide 97: Alkermes plc Portfolio Enables Growth
Alkermes plc Portfolio Enables Growth 97
Slide 98: Alkermes plc Portfolio Enables Growth
Alkermes plc Portfolio Enables Growth 98 Alkermes plc
Slide 99: Elements of Modeling Alkermes plc
Taxes Revenues Interest Income/Expense Adjusted EBITDA Operating Expenses Operating Expenses Elements of Modeling Alkermes plc 99 COGS R&D SG&A Amortization of intangibles
Slide 100: Managing Expenses for Margin Expansion
Managing Expenses for Margin Expansion COGS: Sales growth should drive margin expansion SG&A: Grows with inflation and VIVITROL(r) profits R&D: Major control lever Sufficient funding to advance pipeline Partnership(s) may offset R&D expense 100 (Millions)
Slide 101: Modeling Amortization of Intangibles
Modeling Amortization of Intangibles 101 Intangible Assets Amortized over the life of the applicable collaboration or technology Anticipate annual amortization charge of $45-80 million* booked as operating expense Goodwill Capitalized and subject to annual impairment test * Determined at close Fair
Slide 102: Elements of Modeling Alkermes plc
Taxes Revenues Interest Income/Expense Adjusted EBITDA Operating Expenses Interest Income/Expense Elements of Modeling Alkermes plc 102
Slide 103: Favorable Debt Terms
Favorable Debt Terms Senior secured term loans with blended floating interest rate of 7.6% Flexibility to pre-pay; 1% annual principal amortization $450 million principal $310 million 1st Lien Term Loan - L + 525, LIBOR floor of 150 $140 million 2nd Lien Term Loan - L + 800, LIBOR floor of 150 Matur
Slide 104: Elements of Modeling Alkermes plc
Taxes Revenues Interest Income/Expense Adjusted EBITDA Operating Expenses Elements of Modeling Alkermes plc 104 Taxes
Slide 105: Tax Structure
Tax Structure U.S. Tax Rate Applies to all U.S. income Profits from: RISPERDAL(r) CONSTA(r) VIVITROL(r) Pipeline candidates Interest costs deductible NOLs Federal and state rate of ~38% Irish Tax Rate Applies to all Irish income Profits from: AMPYRA(r) INVEGA(r) SUSTENNA(r) BYDUREON(tm) EDT royaltie
Slide 106: Alkermes plc: Business Objectives
Alkermes plc: Business Objectives 106 Diverse portfolio driving topline growth Efficient investment in pipeline Expanding Adjusted EBITDA margins
Slide 107: www.alkermes.com COPYRIGHT (c) 2011 ALKERMES, INC.
www.alkermes.com COPYRIGHT (c) 2011 ALKERMES, INC.
Slide 108: Q&A
Q&A