Alkermes Plc · NASDAQ:ALKS
Alkermes — 39th Annual J.P. Morgan Healthcare Conference 2021
35 slides from Alkermes's conference presentation, Jan 11, 2021
Slide 1: Focus on Value Creation
Focus on Value Creation Richard Pops Chief Executive Officer 39th Annual J.P. Morgan Healthcare Conference January 13, 2021 Exhibit 99.1
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 mission of, and impact in,
Slide 3: Alkermes' Distinctive Mission
Alkermes’ Distinctive Mission 3 Advance cutting-edge science, develop innovative medicines, and engage in patient-focused advocacy to address critical public health challenges
Slide 4: Execution Against Our Strategic Priorities
Execution Against Our Strategic Priorities Commercial Execution VIVITROL® and ARISTADA® Strong performance in a complex environment Adapted commercial strategy in response to COVID-19 Prepared for synergistic launch of ALKS 3831 within psychiatry portfolio Supported launch of VUMERITY® Advancement o
Slide 5: Focus on Value Creation in 2021: Three Key Components
Focus on Value Creation in 2021: Three Key Components Grow and Diversify Commercial Revenues Demonstrate Value of R&D Investments Manage for Growth & Long-Term Profitability Drive VIVITROL® and ARISTADA® net sales Support VUMERITY® growth Launch ALKS 3831 (PDUFA* June 1, 2021) Nemvaleukin alfa Deter
Slide 6: Value Enhancement Plan and Board Refreshment
Value Enhancement Plan and Board Refreshment Profitability Targets and Cost Structure Optimization Evaluation of Strategic Opportunities Board Refreshment Commitment to achieving: Ongoing review to identify potential areas for improved efficiencies Potential monetization or divestiture of non-core a
Slide 7: Alkermes Commercial Model: Designed to Drive Growth and Competitive Advantage
Alkermes Commercial Model: Designed to Drive Growth and Competitive Advantage Dynamic Market Environment Alkermes Commercial Model Flexible and scalable Allows for rapid adjustment to changes in healthcare landscape Strong field presence supplemented by digital capabilities & non-personal promotion
Slide 8: © 2021 Alkermes. All rights reserved.
© 2021 Alkermes. All rights reserved.
Slide 9: VIVITROL: Distinctive Product for a Major Public Health Need
VIVITROL®: Distinctive Product for a Major Public Health Need Extended-release opioid antagonist provides therapeutic levels of naltrexone for a one-month period Indicated for the treatment of alcohol dependence Indicated for the prevention of relapse to opioid dependence, following opioid detoxific
Slide 10: VIVITROL: Stabilization and Recovery Following COVID-19 Related Disruption
VIVITROL Net Sales ($M) VIVITROL®: Stabilization and Recovery Following COVID-19 Related Disruption VIVITROL Units (Four-week Average) COVID-19 disruptions began VIVITROL stabilization and recovery began *TTM (trailing 12 month) data includes Q4’19 through Q3’20 VIVITROL net sales.
Slide 11: VIVITROL: 2021 Focus
VIVITROL®: 2021 Focus Opioid Dependence (OD) Alcohol Dependence (AD) Focus on select settings of care to increase use of VIVITROL for the prevention of relapse to opioid dependence, following detoxification Accelerate VIVITROL adoption in alcohol dependence by building on the growing use of medicati
Slide 12: © 2021 Alkermes. All rights reserved.
© 2021 Alkermes. All rights reserved.
Slide 13: ARISTADA: LAI for Schizophrenia Suited for Today's Environment
ARISTADA®: LAI for Schizophrenia Suited for Today’s Environment Long-acting injectable (LAI) atypical antipsychotic indicated for the treatment of schizophrenia Novel molecular entity designed to address the real-world needs of patients and providers in the community Full prescribing information for
Slide 14: ARISTADA TRx MOT Growth Outpaced the Atypical LAI Market
ARISTADA® TRx MOT Growth Outpaced the Atypical LAI Market ARISTADA TRx MOT Growth Rate TRx Data: IQVIA NPA data Nov R3 MOT: Months of therapy *TTM (trailing 12 month) data includes Q4’19 through Q3’20 ARISTADA net sales results. ARISTADA Net Sales ($M)
Slide 15: ARISTADA: A Unique Product Offering
ARISTADA®: A Unique Product Offering ARISTADA INITIO® Regimen* ARISTADA 2-Month Dose Only long-acting treatment for schizophrenia that offers: Single-day initiation An option for dosing only six times a year *ARISTADA INITIO + single 30 mg oral dose of aripiprazole replaces need for concomitant thre
Slide 16: Markets Represent Large Opportunities
ORAL AAPs BIPOLAR I DISORDER Atypical Long-acting Injectable (aLAI) and Oral Atypical Antipsychotic (AAP) Markets Represent Large Opportunities aLAIs SCHIZOPHRENIA Branded Market Size* Annual TRx (TTM)** Market Share** $3.2B ~2M 9% ARISTADA® MOT Share $1.5B ~15M 21% olanzapine TRx Share $1.7B ~15M 1
Slide 17: LYBALVI (ALKS 3831): A Potential New Oral Treatment for Schizophrenia and Bipolar I
LYBALVI™* (ALKS 3831): A Potential New Oral Treatment for Adults With Schizophrenia and Adults With Bipolar I Disorder Daily oral investigational antipsychotic designed to offer efficacy of olanzapine; addition of samidorphan intended to mitigate olanzapine-associated weight gain Fixed-dose combinat
Slide 18: Market Research Underscores Real-World Unmet Need and Opportunity
Alkermes Market Research Data Underscores Real-World Unmet Need and Opportunity OLZ is one of the most efficacious oral AAPs for SZ OLZ is the most efficacious oral AAP for maintenance of BD 50% 71% Majority of HCPs Agree OLZ is One of the Most Efficacious Oral AAPs for SZ and BD* Weight Gain is Maj
Slide 19: LYBALVI Focus: Drive Awareness and Plan for Launch in 2021
LYBALVI™ Focus: Drive Awareness and Plan for Launch in 2021 Launch Planning Awareness Engage in scientific exchange with healthcare providers Continue disease state education campaign for caregivers, providers and thought leaders Conduct investigational product presentations with payers Target well-
Slide 20: © 2021 Alkermes. All rights reserved.
© 2021 Alkermes. All rights reserved.
Slide 21: Research and Development Strategy: Focus on High-Value Candidates in Two Key Therapeutic Areas
Neuroscience Oncology Research and Development Strategy: Focus on High-Value Candidates in Two Key Therapeutic Areas Psychiatry Neurology Engineered Cytokines Small Molecules
Slide 22: Nemvaleukin Alfa
Nemvaleukin Alfa (“nemvaleukin”) Formerly referred to as ALKS 4230 Novel investigational immuno-oncology candidate designed to leverage proven anti-tumor effects of interleukin-2 (IL-2) pathway Stable, inherently active, single polypeptide designed to selectively bind to the intermediate-affinity IL
Slide 23: Activation of IL-2 Pathway Offers Broad Potential Clinical Utility
Activation of IL-2 Pathway Offers Broad Potential Clinical Utility IL-2 is a natural regulator of the activity of lymphocytes involved in the immune response Recombinant human IL-2 as monotherapy can drive complete and durable responses in certain tumor types, but its toxicity profile significantly
Slide 24: Nemvaleukin Development Strategy
Nemvaleukin Development Strategy CONFIRM mechanism through immune response SEEK anti-tumor activity signals FOCUS on initial registration pathways BROADEN program to maximize value
Slide 25: Nemvaleukin Development Strategy: Confirm Mechanism
Nemvaleukin Development Strategy Demonstrate clinical pharmacodynamic response reflective of intermediate-affinity IL-2 receptor selectivity Dose-dependent, selective expansion of NK and CD8+ T cells Minimal and non-dose dependent changes in peripheral regulatory T cells Advance into phase 2 expansi
Slide 26: Nemvaleukin Development Strategy: Anti-Tumor Activity
Nemvaleukin Development Strategy Demonstrate monotherapy anti-tumor efficacy Single-agent activity observed in mucosal melanoma and renal cell carcinoma with IV nemvaleukin Demonstrate anti-tumor activity in combination with PD-1 inhibitor Durable and deepening responses observed with IV nemvaleukin
Slide 27: Nemvaleukin Development Strategy: Initial Registration Pathways
Nemvaleukin Development Strategy Select initial tumor types to pursue for registration of IV nemvaleukin Monotherapy: Mucosal melanoma Combination with pembrolizumab: Platinum-resistant ovarian cancer (PROC) Advance discussions on registration plans with regulatory agencies Initiate studies with IV
Slide 28: Nemvaleukin Development Strategy: Broaden Program
Nemvaleukin Development Strategy Identify and select additional tumor types and combinations to pursue Earlier lines of therapy versus standard of care Combinations with targeted and immuno-oncology agents Combinations with radiotherapy, chemotherapy, or other therapies Strategic collaboration CONFI
Slide 29: ALKS 1140: Novel CoREST-Selective HDAC Inhibitor
ALKS 1140: Novel CoREST-Selective HDAC Inhibitor for Neuropsychiatric Indications First candidate nominated from platform of selective HDAC inhibitor compounds Inhibition of the CoREST HDAC complex is a novel approach to increase functional synaptic connections and synaptic integrity Initial clinica
Slide 30: Synapses Play a Vital Role in Brain Function
Synapses Play a Vital Role in Brain Function Synapses are the points of communication within the network of neurons that make up the brain Synaptic function is critical to brain development, learning and memory Synaptogenesis is the formation of synapses between neurons in the nervous system that oc
Slide 31: Many neurological disorders are characterized by synaptic pathology
Many neurological disorders are characterized by synaptic pathology Abnormal density of dendritic spines Synapse loss Aberrant synaptic signaling and plasticity Synapses are a critical target to slow progression and preserve cognitive and functional abilities in multiple neuropsychiatric, neurodegen
Slide 32: ALKS 1140 Selectively Modulates the Function of the CoREST HDAC Complex
ALKS 1140 Selectively Modulates the Function of the CoREST HDAC Complex Criteria achieved for nomination of ALKS 1140 as a candidate to improve synapse formation and synapse function: Selectively inhibits HDAC1/2 specifically associated with the CoREST complex Brain permeable Designed to avoid hemat
Slide 33: Upcoming Q1 Investor Day: Focus on the Pipeline
Upcoming Q1 Investor Day: Focus on the Pipeline Development candidates Nemvaleukin clinical development update ALKS 1140 background and development plan Scientific platforms Engineered cytokines HDAC inhibitors Small molecule medicinal chemistry Therapeutic area focus Psychiatry Neurology Oncology
Slide 34: Focus on Value Creation in 2021
Focus on Value Creation in 2021 Grow and Diversify Commercial Revenues Demonstrate Value of R&D Investments Manage for Growth & Long-Term Profitability
Slide 35: www.alkermes.com
www.alkermes.com
Alkermes — 39th Annual J.P. Morgan Healthcare Conference 2021 on 6ix