Aripiprazole Lauroxil: Preparing for Commercial Success

Transcription

1 Aripiprazole Lauroxil: Preparing for Commercial Success Mark Stejbach Chief Commercial Officer Alkermes R&D Day July 17, 2013

2 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about our prospects for growth, intellectual property protection, market share and market evolution, competitive position, regulatory agency action, commercial launch plans and the anticipated development, timing, data readouts and therapeutic scope and value of our products in clinical development. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those contained in such statements, including, among others: our inability to protect our intellectual property rights and to have sufficient rights to commercialize our products; product competition; clinical trials of our products may be unsuccessful or not initiated or conducted in a timely manner; our products may not show sufficient therapeutic effects or acceptable safety profiles; adverse decisions by regulatory authorities; existing clinical and preclinical data with respect to our products may not be indicative of future clinical or commercial results; unfavorable reimbursement for our products; and our inability to manufacture successfully our products. Additional factors that could cause actual results to differ from those projected in the forward-looking statements are discussed in Alkermes plc s Annual Report on Form 10-K and Form 10-K/A, Quarterly Reports on Form 10-Q and recent Current Reports on Form 8-K, which are available on our website at in the Investors SEC Filings section. These statements are based on our current beliefs and expectations and speak only as of the date of this presentation. We do not undertake any obligation to update any forward-looking statements. 2

3 Agenda 3 Understanding the atypical antipsychotic market Large market evolving favorably for continued growth of long-acting injectables (LAIs) Generational advance: aripiprazole lauroxil Designed with competitive advantages Preparing for a successful launch Comprehensive approach builds off existing capabilities

4 4 Understanding the Atypical Antipsychotic Market

5 More Options Needed for Long-Acting Atypicals 5 Neuroreceptor Binding Activity Haloperidol Risperidone Olanzapine Quetiapine D1 5HT 2A D4 5HT 2C Musc a1 a2 H1 D2 Ziprasidone Aripiprazole Clozapine Data based on both animal and human receptors. In vitro findings may not correlate with clinical efficacy. Sources: Bymaster FP, et al. Neuropsychopharmacology. 1996,14(2):87-96 Schotte A, et al. Psychopharmacology (Berl). 1996, 124(1-2):57-73

6 Aripiprazole is the Leader in a $24B WW Atypical Antipsychotic Market 6 SEROQUEL / quetiapine 26% Other 5% ZYPREXA / olanzapine 18% GEODON / ziprasidone 5% $7.2 Billion RISPERDAL CONSTA 7% RISPERDAL / risperidone 5% ABILIFY / (aripiprazole) 30% INVEGA SUSTENNA 3% INVEGA / paliperidone 3% Sources: U.S. IMS Health, Q3 MAT 2012; 5EU & ROW IMS Midas Q3 MAT 2012; WW market includes U.S., 5EU (Germany, France, Italy, Spain and the UK) and ROW

7 Orals Going Generic: LAIs Will Dominate Share of Voice 7 Risperdal (risperidone) Zyprexa (olanzapine) Geodon (ziprasidone) Oral Injectable Abilify (aripiprazole) Seroquel /Seroquel XR (quetiapine) Invega (paliperidone) RISPERDAL CONSTA Saphris (asenapine) Latuda (lurasidone) INVEGA SUSTENNA Abilify Maintena Aripiprazole Lauroxil Patent Protection

8 Orals Going Generic: LAIs Will Dominate Share of Voice 8 Injectable INVEGA SUSTENNA RISPERDAL CONSTA Abilify Maintena Aripiprazole Lauroxil Patent Protection

9 Quarterly Sales (Millions) Quarterly Sales $ Millions WW LAIs Growing Despite Oral Generics 9 $1,000 $900 $800 $700 $600 $500 $400 $300 $200 $100 $0 Mar-11 Jun-11 Sep-11 Dec-11 Mar-12 Jun-12 Sep-12 Dec-12 RISPERDAL CONSTA INVEGA SUSTENNA Zyprexa Relprevv Haloperidol Decanoate Fluphenazine Decanoate Sources: IMS Health 2011, 2012 and IMS MIDAS 2011, 2012

10 Europe Outpaces U.S. in Adoption of LAIs for Schizophrenia Treatment 10 25% Percent of Patients With Schizophrenia Prescribed RISPERDAL CONSTA or INVEGA SUSTENNA 20% 15% 10% 5% 0% U.S. Italy UK Germany France Spain Decision Resources. Schizophrenia. Pharmacor Report. Jan

11 Focus on Relapse Prevention Helps Patients and Payers and Supports the Use of LAIs 11 Substantial evidence supports the need for relapse prevention 1,2,3,4,5 Multiple relapses and remissions cause irreversible consequences Over time, relapses also impact social function and increase mortality rate Up to 10 times higher mortality rate in untreated vs. treated patients Significant pharmacoeconomic benefit supports the use of LAIs Average annual hospitalization days (all-cause) were ~30% lower for patients after switching from oral to LAI antipsychotic treatment 6 Average annual hospitalization payments were ~35% lower for patients after switching from oral to LAI antipsychotic treatment 6 1 NIMH Fact Sheet, rev Sadock BJ, et al Kaplan and Sadock's Comprehensive Textbook of Psychiatry. 8th Edition. Philadelphia: Lippincott Williams & Wilkins 3 APA 2004; Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision 4 APA Practice Guidelines, Tiihonen J, et al. BMJ, doi: /bmj f (published 6 July 2006) 6 Karson CN. Impact of Switching From Oral to Long-Acting Injectable Antipsychotic Medications Among Medicaid Insured Patients With Schizophrenia. Abstract presented at NCDEU Meeting Retrospective insurance claims database analysis of 2,883 Medicaid patients switching from oral to LAI antipsychotics

12 Opportunity to Move LAIs Earlier in Treatment 12 Frequency of LAI Prescribers Discussing LAI Option in Schizophrenia (5-point scale) Newly Diagnosed With First Episode 47% 31% 22% One Relapse and Currently Stable 26% 36% 38% Multiple Relapses and Currently Stable 6% 27% 67% Multiple Relapses and At Risk for Another Episode 11% 87% Never/Rarely (1, 2) Sometimes (3) Always (4, 5) Source: Alkermes data on file N=151 psychiatrists who prescribe long-acting injectable antipsychotics.

13 Sales (Billions) New Therapeutic Entrants Drive Market Growth 13 Case Study: U.S. Biologics Rheumatoid Arthritis Market $8 $7 $6 $5 Simponi Cimzia $4 Orencia $3 Humira $2 $1 $0 Remicade Enbrel MAT May Sources: IMS Health , SDI Health-Encuity

14 14 Generational Advance: Aripiprazole Lauroxil

15 Building the LAI Atypical Class Through Generational Advancement 15 First-in-Class Product Attributes First long-acting atypical Dosing every two weeks Requires reconstitution Requires refrigeration Gluteal administration at launch Generational Advances Once-monthly dosing Pre-filled syringe Non-refrigerated Deltoid and gluteal administration at launch

16 Aripiprazole Lauroxil Designed as Generational Advancement 16 Aripiprazole Lauroxil First Long-Acting Aripiprazole Requires reconstitution 400mg (maintenance strength) Gluteal administration Generational Advances Pre-filled syringe Multiple maintenance strengths to cover entire oral aripiprazole dosage range Deltoid and gluteal administration

17 Percent Drug Dose Used in Treatment Dosing Flexibility Required to Meet Range of Patient Needs 17 Oral Aripiprazole Daily Dose for Schizophrenia ( ) 100% 2% 1% 90% 80% 22% 30% 70% 7% 60% 20% 50% 40% 58% 19% 30% 20% 14% 10% 0% 13% 10% 1% 3% mg 2 5mg 10mg 15mg 20mg 30mg OTH Source: Encuity Health, PDDA drug uses, 2003 to 2012

18 Percent Drug Dose Used in Treatment Shift to Higher Strengths for Schizophrenia; ~30% of Patients Treated With 30mg Dose 18 Oral Aripiprazole Daily Dose for Schizophrenia ( ) 100% 2% 1% 90% 80% 22% 30% 70% 7% 60% 20% 50% 40% 58% 19% 30% 20% 14% 10% 0% 13% 10% 1% 3% mg 2 5mg 10mg 15mg 20mg 30mg OTH Source: Encuity Health, PDDA drug uses, 2003 to 2012

19 Abilify Maintena Priced at a Premium Per Dose 19 INVEGA SUSTENNA (WAC) Abilify Maintena (WAC) Maintenance Strength Price Maintenance Strength Price 117mg $ mg $1, mg $1, Price per maintenance dose Sources: ProspectoRx 2013, product prescribing information

20 Cumulative Cost of Therapy (WAC) Abilify Maintena Affirms Pricing of LAIs: Cost-Competitive to INVEGA SUSTENNA 20 $10,000 $9,000 $8,000 $7,000 $6,000 $5,000 $4,000 INVEGA SUSTENNA 117mg INVEGA SUSTENNA 156mg Abilify Maintena 400mg Cost of INVEGA SUSTENNA loading dose $3,000 $2,000 $1,000 $ Months of Therapy Sources: ProspectoRx 2013, product prescribing information

21 Abilify Maintena Kit 21 Vial adapter 5mL vial sterile water PI 21G 1.5 inch needle 21G 2.0 inch needle 3mL BD syringe with 21G 1.5 inch needle 3mL BD syringe Aripiprazole lyophilized powder DFU multiple steps

22 Aripiprazole Lauroxil: Designed to be a Generational Advancement for the Treatment of Schizophrenia 22 Product presentation, storage and handling Pre-filled syringe Non-refrigerated Deltoid and gluteal administration Dose range Three doses to cover the range of oral Abilify doses with ability to titrate Multinational phase 3 registration study underway Data anticipated H1 CY 14 NDA submission CY 14, launch CY 15

23 23 Preparing for a Successful Launch

24 J&J, Otsuka and Lundbeck Focused on Building the Market for Long-Acting Injectables 24 Risperdal Consta provides ConstaCoverage - assurance that antipsychotic medication is on board when administered every 2 weeks Certainty that comes with a once-monthly option. From CERTAINTY comes possibilities. Introducing a new option to help protect your patients with schizophrenia from relapse

25 Alkermes is Building on This Foundation With Aripiprazole Lauroxil 25 Position the product as a generational advance Emphasize efficacy and safety of aripiprazole Differentiate from Abilify Maintena Focus launch on identified targets Focus efforts on appropriate stakeholders: physicians, nurses and patient advocacy groups Convert appropriate patients from oral and LAI antipsychotics Secure patient access Establish reimbursement coverage Position LAIs for earlier use in schizophrenia

26 Total U.S. Abilify Sales of ~$6 Billion, With $1.4 Billion in Schizophrenia 26 Sales of Abilify by Indication Total 2012 U.S. Sales of Abilify = $5.9B Schizophrenia Other Bipolar Disorder Depression Other indications include but are not limited to: neurotic disorders, personality disorders, childhood psychosis, infantile autism Sources: IMS Health, accessed on June 18, 2013, Encuity PDDA, accessed on June 18, 2013

27 U.S. Launch Will Focus on Conversion From Oral Atypicals to Aripiprazole Lauroxil 27 Sales by Patient Segment Other Oral Antipsychotics (Bipolar) Low Other Oral Antipsychotics (Schizophrenia) $1.5B $2.2B Ease of Conversion $2.8B Abilify (Bipolar) High $1.4B Abilify (Schizophrenia) At Launch Later Commercial Priority Sources: IMS Health (Total Patient Tracker) 2012 and Encuity Health 2012

28 U.S. Launch Will Focus on Conversion From Oral Atypicals to Aripiprazole Lauroxil 28 Sales Patient by Patient Segments Segment Other Oral Antipsychotics (Bipolar) Low Other Oral Antipsychotics (Schizophrenia) 1.6M Ease of Conversion 2.1M 555K Abilify (Bipolar) High 354K Abilify (Schizophrenia) At Launch Later Commercial Priority Sources: IMS Health (Total Patient Tracker) 2012 and Encuity Health 2012

29 Comprehensive Launch Plan to Address Range of Stakeholders 29 Adoption: KOLs, professional and patient associations, treatment center/hospital administrators, payers Use/administration: Psychiatrists, nurses, nurse practitioners, primary care physicians, ER staff, hospital/cmhc pharmacists Influence: Nurses, psychologists, counselors, case workers, caregivers Adherence/support: Family, spouse, friends, support groups Reimbursement and access: Medicaid FFS/MCO, Medicare Part D, private insurance plans, VA/DoD, judicial system Distribution: Wholesalers, PBMs, specialty pharmacies

30 Comprehensive Launch Plan to Address Range of Stakeholders 30 Adoption: KOLs, professional and patient associations, treatment center/hospital administrators, payers Use/administration: Psychiatrists, nurses, nurse practitioners, primary care physicians, ER staff, hospital/cmhc pharmacists Psychiatrists Influence: Nurses, psychologists, counselors, case workers, caregivers Adherence/support: Family, spouse, friends, support groups Reimbursement and access: Medicaid FFS/MCO, Medicare Part D, private insurance plans, VA/DoD, judicial system Reimbursement and access nurses Distribution: Wholesalers, PBMs, specialty pharmacies

31 Half of Abilify High-Prescribers Already Use LAIs 31 Abilify High-Prescribers Do Not Use LAIs 50% Psychiatrists Use 34% LAIs 50% First Priority: All Current LAI Prescribers (12,574) Other 2% PCP 8% Nurse Practitioners 6% Source: IMS Health 2012

32 Half of Abilify High-Prescribers Already Use LAIs 32 Abilify High-Prescribers Do Not Use LAIs 50% Psychiatrists Use 34% LAIs 50% Next Priority: First Priority: High Prescribers of All Current LAI Abilify Not Yet Using Prescribers (12,574) LAIs Other 2% PCP 8% Nurse Practitioners 6% Source: IMS Health 2012

33 Prescribers Segmented Based on Their Use of LAIs and Oral Aripiprazole 33 LAI ARI 2012 LAI Atypical Antipsychotics and Oral Aripiprazole Oral Aripiprazole Decile 10-4 Prescribers: 24,055 LAI Decile 10-1 Prescribers: 12, Total , ,298 3,104 7,011 LAI Prescribers Non-LAI Prescribers ,127 1,367 1,686 2,180 4,811 12, ,065 1,552 2,370 5,066 11,481 Total 778 1,341 1,839 2,432 3,238 4,550 9,877 24,055 Source: IMS Health 2012: Total prescriptions for fluphenazine decanoate, haloperidol decanoate, INVEGA SUSTENNA, RISPERDAL CONSTA and Abilify. IMS did not create this table and is not responsible for this market definition, nor subsequent use of this data.

34 Total FTEs Concentrated Base of Targeted Prescribers Allows for Specialty Sales Model 34 Estimated J&J LAI U.S. Sales Force Size Source: Cegedim CSD Analzyer Other customers, such as counselors and administrative staff, are not captured. Assumption: 200 field days, 6 details per day. Excludes sales managers, advocacy and managed markets FTEs.

35 Nurses Are Important 35 Administer the majority of injections Often provide input on treatment decisions for LAIs Product presentation and convenience matter in real-world clinical settings Nurses 76% Who Administers LAIs? Other 10% PSY 14% Source: Alkermes data on file (N=165 psychiatrists)

36 LAIs Administered in Three Distinct Treatment Settings 36 Community Mental Health Centers Private Offices Hospitals Pivotal hub that connects to hospital and home LAI injection/administration or home services Psychiatrists, supported by HCPs (nurses) May also treat other CNS disorders Provides short-term ER/inpatient services, with first injection of LAI Connects patients with CMHC or private office for continued treatment Outpatient injection services Treatment Settings for Administration of LAIs in Medicaid Patient Population CMHC 40% Other 3% Home 16% Office 24% Based on 11,049 schizophrenia patients with a place of service associated with an LAI claim Hospital 17% Source: Truven Health Market Scan 2012

37 Frameworks for LAI Reimbursement Already Established 37 Coverage and formularies for LAIs already established in public and private plans Varying degrees of access in place (tiering, prior authorization, fail-first criteria, protected class for Medicare Part D, quantity limits) Can be identified by specific state and managed care plan by product Government entities represent the majority of payers for schizophrenia treatment Mental illness community has a base of advocates for access to treatment options, including established state patient groups Environment is favorable; expanded coverage through Affordable Care Act may represent new opportunity

38 Public Payers Cover Majority of LAI Patients 38 Medicaid Medicare Part D Commercial State program Delivered through managed care organizations or fee-for-service National program managed through commercial insurance Covers <65 years of age with disability Dual-eligible patients (with Medicaid) National/regional plans Typically employer-based insurance Medicaid 66% INVEGA SUSTENNA Patient Coverage Mix 2012 OTH 6% Medicare Part D 19% Commercial 9% Source: Kaiser 2011, Encuity, PDDA: 2012

39 Top Ten Medicaid States: Targeted Strategy for Launch 39 Medicaid Lives and Coverage by State 1 States Total Medicaid Lives MCO Lives MCO Plans 2 FFS Lives Drug Carve-In 3 California 7,580,978 4,553,090 (60%) 20 3,027,888 Yes New York 4,925,236 3,777,868 (77%) 19 1,147,368 Yes Texas 3,943,189 2,786,985 (71%) 20 1,156,204 Yes Florida 3,069,456 1,958,679 (64%) 23 1,110,777 No Centralized state Medicaid formulary Target top MCO plan formularies Illinois 2,787,200 1,888,500 (68%) 2 898,700 Yes Pennsylvania 2,134,956 1,740,659 (82%) ,297 No Ohio 2,129,706 1,605,821 (75%) 7 523,885 Yes Michigan 1,818,312 1,606,688 (88%) ,576 No Massachusetts 1,566, ,064 (53%) ,449 No Georgia 1,548,090 1,413,643 (91%) 2 233,374 No All Others 25,603,596 20,220,542 (79%) 150 6,822,661 11: Yes Total 57,106,941 42,384,539 (74%) ,722,402 16: Yes 1 Kaiser Medicaid Report Fingertip Formulary Kaiser State healthfacts.org, other states with Medicaid drug carve-ins: CT, DE, IN, MO, NJ, OR, UT, WV, WI

40 75% of Florida Medicaid Lives Covered by Four Payers 40 Medicaid MCO and State (FFS) Medicaid MCOs Simply Healthcare 2% Prestige Health Choice 5% Preferred Medical Plan 1% Universal U-First 5% UnitedHealthcare Community Plan 6% Sunshine Health 13% FL- Medicaid 36% Molina 5% Integral Quality Care 2% MCO 64% Humana Family 3% Health Care District 1% WellCare 34% Freedom 1st Medicaid 2% Florida Health Care Plans <1% Florida Blue <1% Coventry Healthcare 5% Amerigroup 14% Medicaid Lives = 3,069,456 Key MCO Plans Covering Medicaid Lives in Florida Sources: Kaiser report 2011, Fingertip Formulary 2013

41 Rapid Access to INVEGA SUSTENNA Achieved in Key Medicaid States With Centralized Formularies 41 Medicaid State Plans California Pharmacy Benefit Status at Launch (Dec. 2009) Tier 1 (PA-NP) New York Tier 1 Texas Tier 1 Illinois Tier 2 (PA-NP) Ohio Tier 2: Dec PA: Prior Authorization NP: Not Preferred Source: Fingertip Formulary

42 Mobilizing for Commercial Success 42 LAI market poised for significant growth Aripiprazole lauroxil designed to be a generational advance Preparing for a successful launch

43