Alkermes Plc · NASDAQ:ALKS

Alkermes — 37th Annual J.P. Morgan Healthcare Conference (January 2019)

52 slides from Alkermes's conference presentation, Jan 7, 2019

  1. Slide 1: Taking on Critical Public Health Challenges

    Taking on Critical Public Health Challenges Richard Pops Chief Executive Officer 37th Annual J.P. Morgan Healthcare Conference JANUARY 8, 2019 Exhibit 99.1

  2. Slide 2: Forward-Looking Statements

    Forward-Looking Statements Certain statements set forth in this presentation constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company’s expectations with respect t

  3. Slide 3: Drug development driven by real-world needs of patients

    Drug development driven by real-world needs of patients Using deep scientific expertise and clinical insights to develop medicines designed to positively impact the lives of patients, families and communities Patient-Inspired Medicines: Making a Real Impact Distinctive focus in mental health and add

  4. Slide 4: Focus on Diseases With Major Public Health Implications

    Focus on Diseases With Major Public Health Implications Schizophrenia and Related Disorders Alliance of America, https://sardaa.org/resources/about-schizophrenia/ accessed on Jan. 2, 2019 Substance Abuse and Mental Health Services Administration (SAMHSA). 2017 National Survey on Drug Use and Health

  5. Slide 5: Transformational Progress Over the Past Years

    Transformational Progress Over the Past 5 Years Meaningful impact on patients ~365K patients1 treated with VIVITROL® or ARISTADA® Enhanced scale of the business Crossing $1B in expected total revenue in 20182 Increased annual proprietary product net sales by 528%3 Sophisticated commercial infrastruc

  6. Slide 6: Establishing a Leadership Position in Schizophrenia

    Establishing a Leadership Position in Schizophrenia © 2019 Alkermes. All rights reserved.

  7. Slide 7: Significant Opportunity to Help Address Needs in Schizophrenia

    Schizophrenia is a serious mental illness that affects ~3.5M patients in the U.S.1 Treatment and other economic costs due to schizophrenia are estimated to be between $32B - $65B annually1 Available antipsychotic treatments present trade-off between efficacy and tolerability Oral therapies dominate

  8. Slide 8: Opportunity to Provide New Medicines With Efficacy and Tolerability

    Opportunity to Provide New Medicines With Efficacy and Tolerability Efficacy Tolerability Highly Efficacious and Well Tolerated Highly Efficacious Well Tolerated

  9. Slide 9: Developing Important New Medicines for the Treatment of Schizophrenia

    Developing Important New Medicines for the Treatment of Schizophrenia Long-acting injectable prodrug new molecular entity (NME) ALKS 3831 Investigational, oral bilayer tablet, olanzapine plus novel NME

  10. Slide 10: Integrated Infrastructure Scaled to Address Complex Disease Areas

    Integrated Infrastructure Scaled to Address Complex Disease Areas Health Systems Government & Commercial Payers Field Reimbursement Support Hospital Team State and Federal Policy Compliance Patient Services Medical Affairs National Sales Organization

  11. Slide 11: Evolution of Alkermes' Schizophrenia Franchise

    Evolution of Alkermes’ Schizophrenia Franchise First atypical LAI (two-week dose) Janssen product using Alkermes proprietary technology First monthly atypical LAI No refrigeration, no oral lead-in, prefilled syringe Janssen product using Alkermes proprietary technology 2003 RISPERDAL CONSTA® First a

  12. Slide 12: ARISTADA: Long-Acting Injectable for Treatment of Schizophrenia

    Differentiated medicine provides proven efficacy and safety Four approved doses Three dosing intervals: Monthly, six-week, two-month 1-day initiation with ARISTADA INITIO® regimen* ARISTADA®: Long-Acting Injectable for Treatment of Schizophrenia ARISTADA product family is designed to address the rea

  13. Slide 13: Key Differentiating Feature: Treatment Initiation With ARISTADA INITIO

    ARISTADA® is the first and only LAI with the ability to fully dose on day one* for up to two months Initiation regimen* designed with needs of patients, healthcare providers and treatment settings in mind Supports continuity of care from inpatient to outpatient settings One-third of LAI initiations

  14. Slide 14: ARISTADA INITIO Plus Two-Month: Building the Evidence Base

    Phase 3b study designed to provide clinical evidence of efficacy and safety of ARISTADA INITIO plus ARISTADA® two-month dose alongside market leader, INVEGA SUSTENNA® Follows positive data from INVEGA SUSTENNA/ARISTADA switch study presented at U.S. Psych Congress in 2017* Data expected H1 2019 Prim

  15. Slide 15: ARISTADA: Differentiated in the LAI Market

    ARISTADA®: Differentiated in the LAI Market *ARISTADA INITIO + single 30 mg oral dose of aripiprazole provides an alternative for concomitant three weeks of oral aripiprazole for initiation of ARISTADA, with relevant levels of aripiprazole concentration reached within four days. ARISTADA INITIO was

  16. Slide 16: High-Growth U.S. LAI Atypical Antipsychotic Market

    High-Growth U.S. LAI Atypical Antipsychotic Market Potential to be $3-4B+ U.S. market in 2020 $2.476B Sources: Johnson & Johnson, Otsuka, Lundbeck and Alkermes quarterly reports. Net Sales ($M) ARISTADA® 10/2015 INVEGA SUSTENNA® 8/2009 ABILIFY MAINTENA® 3/2013 RISPERDAL CONSTA® 12/2003 INVEGA TRINZA

  17. Slide 17: ARISTADA: Growing Into its Potential

    ARISTADA INITIO® regimen* plus ARISTADA two-month dose New clinical data expected in 2019 Expanded commercial team increasing provider awareness; Hospital commercial organization targeting new starts Collaborating with policymakers and industry peers to improve treatment system for serious mental il

  18. Slide 18: ALKS 3831: A New Potential Oral Treatment for Schizophrenia

    Designed to offer robust efficacy of olanzapine with favorable weight and metabolic properties Samidorphan expands olanzapine’s spectrum of activity to help mitigate weight gain liability Registration studies now complete Efficacy, safety and weight gain profile confirmed in two large, phase 3 studi

  19. Slide 19: Olanzapine Associated With Abdominal Weight Gain

    Olanzapine Associated With Abdominal Weight Gain1 Abdominal Obesity Correlated With Metabolic Syndrome2 Insulin resistance Elevated blood pressure Dyslipidemia Cardiovascular risk Gilles et al. Clinical Neuropharmacology. 33(5):248-249, Sept. 2010. Richie et al. Nutr Metab Cardiovasc Dis. 2007 May;1

  20. Slide 20: ALKS 3831: Efficacy, Safety and Weight Gain Profile Confirmed in Two Phase 3 Studies

    ALKS 3831: Efficacy, Safety and Weight Gain Profile Confirmed in Two Large, Phase 3 Studies Antipsychotic efficacy vs. placebo 403 patients with acute schizophrenia ALKS 3831 demonstrated statistically significant reductions from baseline in PANSS scores at 4 weeks, compared to placebo (p<0.001) Ola

  21. Slide 21: ENLIGHTEN-1: Demonstrated Robust Antipsychotic Efficacy

    ENLIGHTEN-1: Demonstrated Robust Antipsychotic Efficacy Change from Baseline at Week 4 PBO (N=112) ALKS 3831 (N=124) OLZ (N=120) Mean (SD) -19.4 (14.80) -23.7 (12.61) -22.4 (13.63) LS Mean (SE) -17.5 (1.32) -23.9 (1.28) -22.8 (1.29) LS Mean Difference (SE) vs. Placebo -6.4 (1.83) -5.3 (1.84) P-Value

  22. Slide 22: ENLIGHTEN-2: Primary Analysis Captures Shift in Two Dimensions

    ENLIGHTEN-2: Primary Analysis Captures Shift in Two Dimensions Percent Weight Change From Baseline Number of Subjects 10% Co-primary Endpoint (Continuous): Population Average Weight Gain (mean) Co-primary Endpoint (Categorical): 10% or Greater Weight Gain Secondary Endpoint (Categorical): 7% or Grea

  23. Slide 23: ENLIGHTEN-2: Shift in Mean Has Beneficial Weight Implications

    ENLIGHTEN-2: Shift in Mean has Beneficial Weight Implications for Entire Study Population Percent Weight Change From Baseline Number of Subjects Olanzapine ALKS 3831 Weight Loss or Insignificant Weight Gain Clinically Significant Weight Gain For illustrative purposes only

  24. Slide 24: ENLIGHTEN-2: Pre-Specified Primary and Key Secondary Endpoints

    ENLIGHTEN-2: Pre-Specified Primary and Key Secondary Endpoints Olanzapine ALKS 3831 Co-Primary Endpoints: Mean Weight Gain 6.59% 4.21% p-value p=0.003* Proportion of Subjects with Weight Gain of ≥10% From Baseline 29.8% 17.8% p-value p=0.003* Secondary Endpoint: Proportion of Subjects with Weight Ga

  25. Slide 25: ENLIGHTEN-2 Results: Clinical Implications for Patients

    ENLIGHTEN-2 Results: Clinical Implications for Patients of ALKS 3831 patients did not gain clinically meaningful* weight from baseline 73% the risk of clinically meaningful* weight gain from baseline with olanzapine vs. ALKS 3831 2.0x higher mean percent weight change at six months for patients who

  26. Slide 26: ENLIGHTEN-2: ALKS 3831 Weight Profile Stabilized

    ENLIGHTEN-2: ALKS 3831 Weight Profile Stabilized Percent Change from Baseline (LS Mean +/- SE) * * ** ** ** ** Note: Weight curve based on analysis of covariance (ANCOVA) approach using multiple imputation (MI) for missing data. *p<0.05 vs. olanzapine; **p<0.01 vs. olanzapine

  27. Slide 27: Antipsychotic Efficacy Key Attribute for Healthcare Providers

    Alkermes research; n=66 Psychs, NPs, PAs Antipsychotic Efficacy Key Attribute for Healthcare Providers Olanzapine Market Share 19% Despite Weight Liabilities Motivating Elements of the ALKS 3831 Profile Healthcare Provider Market Research 19% Sources: IMS NPA Audit R12M Sep 2018, IMS SOB File Effica

  28. Slide 28: Next Steps for ALKS 3831 Program

    Advancing toward regulatory submission for schizophrenia Anticipated pre-NDA meeting to discuss key FDA requirements including efficacy, safety, weight and metabolic profile NDA submission planned for mid-2019 Publication of data and scientific education Plan to present ENLIGHTEN-2 data at spring me

  29. Slide 29: VIVITROL for Opioid and Alcohol Dependence

    VIVITROL® for Opioid and Alcohol Dependence © 2019 Alkermes. All rights reserved.

  30. Slide 30: VIVITROL for Opioid and Alcohol Dependence

    VIVITROL® for Opioid and Alcohol Dependence VIVITROL is 1 of 3 FDA-approved treatment options for opioid dependence* *To be used in conjunction with psychosocial support Long-acting injectable opioid antagonist provides therapeutic levels of naltrexone for a one-month period Only medication approved

  31. Slide 31: Opioid Epidemic Continues to Rage Nationwide

    In 2017 11.1M people misused prescription opioids1 2.1M people reported having Opioid Use Disorder1 Fentanyl-related overdose deaths increased ~45%2 Opioid overdose deaths drove down U.S. life expectancy over the last three years3 Opioid Epidemic Continues to Rage Nationwide Substance Abuse and Ment

  32. Slide 32: 13,084 Facilities Providing Substance Abuse Services

    National: 13,084 Facilities Providing Substance Abuse Services 1 2 3+ Number of Facilities in County Source: opioid.amfar.org accessed on Jan. 2, 2019 .

  33. Slide 33: Fewer Than 50% Offer Any FDA-Approved Opioid Use Disorder Medication

    Fewer Than 50% Offer Any FDA-Approved Opioid Use Disorder Medication National: 5,470 1 2 3+ Number of Facilities in County Source: opioid.amfar.org accessed on Jan. 2, 2019 .

  34. Slide 34: Fewer Than 5% Offer All Three FDA-Approved Medication Types

    Fewer Than 5% Offer All Three Types of FDA-Approved Opioid Use Disorder Medications National: 391 1 2 3+ Number of Facilities in County Source: opioid.amfar.org accessed on Jan. 2, 2019 .

  35. Slide 35: VIVITROL: Demonstrated Growth With New Opportunities Arising

    VIVITROL®: Demonstrated Growth With New Opportunities Arising VIVITROL Net Sales ($M) 33% CAGR Public policy initiatives and improved access driving strong growth in new states 27 states have demonstrated more than 25% growth year-over-year (Q3’18 YTD) New state and federal funding slowly catalyzing

  36. Slide 36: Diroximel Fumarate for Multiple Sclerosis

    Diroximel Fumarate for Multiple Sclerosis (Formerly BIIB098) © 2019 Alkermes. All rights reserved.

  37. Slide 37: Diroximel Fumarate (DRF) for Multiple Sclerosis

    Novel, oral investigational fumarate for the treatment of relapsing forms of MS (RRMS), designed to provide differentiated features vs. dimethyl fumarate Administered in oral, micro pellet, controlled-release dosage form Composition of matter patent extends into 2033 NDA submitted in December 2018 S

  38. Slide 38: Diroximel Fumarate: EVOLVE-MS-1 Reveals Efficacy and Tolerability

    Diroximel Fumarate: EVOLVE-MS-1 Reveals Efficacy and Tolerability Patients, n (%) Months 0 - 1 after treatment initiation (n=580) Discontinuations due to GI AEs 3 (0.5) Serious GI AEs 0 Most common TEAEs (>5% of patients) Flushing Pruritus Diarrhea 184 (31.7) 43 (7.4) 38 (6.6) Months 0–3 after treat

  39. Slide 39: Multiple Sclerosis is a Large and Growing Market

    Multiple Sclerosis is a Large and Growing Market Biogen License and Collaboration Agreement Granted Biogen an exclusive, worldwide license to commercialize DRF Mid-teens percentage royalty to Alkermes on worldwide net sales of DRF Received $50M payment in Q2 2018 following Biogen’s preliminary revie

  40. Slide 40: ALKS 4230 and Emerging Biologics Capabilities

    ALKS 4230 and Emerging Biologics Capabilities © 2019 Alkermes. All rights reserved.

  41. Slide 41: ALKS 4230: Selective IL-2 Fusion Protein

    Novel investigational immunotherapy designed to enhance tumor-killing T cells Selective activation of IL-2 intermediate affinity receptors Demonstrated preferential expansion of Natural Killer and CD8+ T cells with minimal expansion of regulatory T cells Potential to be complementary to a range of c

  42. Slide 42: ALKS 4230 Preference for Binding to IL-2 Intermediate-Affinity Receptors

    ALKS 4230 has Increased Preference for Binding to IL-2 Intermediate-Affinity Receptors IL-2Rb gc IL-2Rb gc IL-2Ra ALKS 4230 ALKS 4230 X IL-2 Intermediate-Affinity Receptors IL-2 High-Affinity Receptors

  43. Slide 43: Combination Therapy: ALKS 4230 + Pembrolizumab

    Combination Therapy: ALKS 4230 + Pembrolizumab PD-1 Approved Tumor Types Treatment Naïve Patients PD-1 Unapproved Tumor Types* Monotherapy Rollover PD-1 Approved Tumor Types Refractory Patients Renal Cell Carcinoma Cohort Melanoma Cohort ALKS 4230 Phase 1 Study Design Monotherapy Dose Escalation Mon

  44. Slide 44: ALKS 4230 Pharmacokinetics and Pharmacodynamic Effects From Phase 1

    ALKS 4230 Pharmacokinetics and Pharmacodynamic Effects From Phase 1 Ongoing Dose Escalation Study ALKS 4230 resulted in a dose-dependent increase in circulating NK and CD8+ T cells with an approximately 4-fold and 2-fold expansion at 3 µg/kg/day, respectively, and minimal, non-dose dependent change

  45. Slide 45: ALKS 5461 for Adjunctive Treatment of Major Depressive Disorder

    ALKS 5461 for Adjunctive Treatment of Major Depressive Disorder © 2019 Alkermes. All rights reserved.

  46. Slide 46: ALKS 5461 for the Adjunctive Treatment of MDD

    Investigational opioid system modulator Administered once daily as a single, sublingual tablet Efficacy and safety data from FORWARD-4 and FORWARD-5 published in Molecular Psychiatry NDA submitted January 2018; PDUFA target action date Jan. 31, 2019 Expecting Complete Response Letter; Determining ne

  47. Slide 47: Consistent Efficacy for ALKS 5461

    Consistent Efficacy for ALKS 5461 Pre-specified Primary endpoint MADRS-10AVG MADRS-10EOT 2 of the 4 pivotal trials met their primary endpoint 3 of the 4 trials demonstrate evidence of efficacy 2 of the 4 trials demonstrate evidence of efficacy

  48. Slide 48: Consistent Safety and Tolerability Profile of ALKS 5461

    Data from FORWARD core efficacy studies demonstrate consistent safety and tolerability profile High completion rate (85%) Most common adverse events included nausea, constipation and dizziness Generally mild, transient and occurring around treatment initiation Extensive dataset >1,500 subjects parti

  49. Slide 49: Advancing Late-Stage Pipeline

    Advancing Late-Stage Pipeline DEVELOPMENT CANDIDATES PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 FDA REVIEW ALKS 5461 (Major Depressive Disorder) ALKS 3831 (Schizophrenia) Diroximel Fumarate (BIIB098)* (Multiple Sclerosis) ALKS 4230 (Immuno-oncology) *Diroximel fumarate New Drug Application submitted to FD

  50. Slide 50: Significant News Flow Expected in 2019

    ARISTADA® Report topline results for phase 3b ARISTADA-INVEGA SUSTENNA® study (H1) ALKS 3831 Present ENLIGHTEN-2 data at medical meeting (H1) Submit NDA for schizophrenia (mid-year) VIVITROL® Present and publish data on detox and induction strategies Diroximel fumarate Report topline data for EVOLVE

  51. Slide 51: Alkermes Values and Mission

    Alkermes Values and Mission Our purpose Great Science Deep Compassion Real Impact Collaboration Our values (22019 Anema Ages ese

  52. Slide 52: www.alkermes.com

    www.alkermes.com © 2019 Alkermes. All rights reserved.

Alkermes — 37th Annual J.P. Morgan Healthcare Conference (January 2019) on 6ix