Alkermes Plc · NASDAQ:ALKS
Alkermes — 38th Annual J.P. Morgan Healthcare Conference 2020
42 slides from Alkermes's conference presentation, Jan 13, 2020
Slide 1: Shaping the Future of the Business
Shaping the Future of the Business Richard Pops Chief Executive Officer Exhibit 99.1 38th Annual J.P. Morgan Healthcare Conference January 15, 2020
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 advancing patien
Slide 3: Alkermes' Distinctive Mission and Impact
Alkermes’ Distinctive Mission and Impact Through our advocacy, we advance patient-centered care and seek to redefine what constitutes successful treatment. Our science and medicines are making a real-world impact in the treatment of serious diseases.
Slide 4: Actively Shaping the Future of the Business
Advancing a diversified CNS and oncology pipeline Positioning the business to deliver long-term growth and profitability Expanding and driving growth of our product portfolio Actively Shaping the Future of the Business
Slide 5: Expanding and Driving Growth of Our Product Portfolio
Expanding and Driving Growth of Our Product Portfolio
Slide 6: Proprietary Commercial Products for Addiction and Schizophrenia
Proprietary Commercial Products for Addiction and Schizophrenia Extended-release opioid antagonist provides therapeutic levels of naltrexone for a one-month period Only medication indicated for the prevention of relapse to opioid dependence, following opioid detoxification; Indicated for the treatme
Slide 7: $1 Billion Topline Commercial Enterprise Driven by Growth of Proprietary Products
$1 Billion Topline Commercial Enterprise Driven by Growth of Proprietary Products Proprietary Product Net Sales ($M) 2019 Growing proprietary commercial products VIVITROL® ARISTADA® Financial foundation of license, royalty and manufacturing revenues New potential revenue elements: 2020 Royalty and m
Slide 8: VUMERITY (Diroximel Fumarate) for Multiple Sclerosis (MS)
VUMERITY® (Diroximel Fumarate) for Multiple Sclerosis (MS) Novel oral fumarate with a distinct chemical structure for the treatment of relapsing forms of MS Discovered and developed by Alkermes Approved by FDA in October 2019 Exclusive, worldwide license to commercialize held by Biogen Launched by B
Slide 9: ALKS 3831: A Potential New Oral Treatment for Schizophrenia and Bipolar I Disorder
ALKS 3831: A Potential New Oral Treatment for Adults With Schizophrenia and Adults With Bipolar I Disorder Investigational antipsychotic designed to offer robust efficacy of olanzapine; addition of samidorphan intended to mitigate olanzapine-associated weight gain Single NDA for treatment of adults
Slide 10: Olanzapine: Atypical Antipsychotic Treatment Driven by Efficacy
Olanzapine: Atypical Antipsychotic Treatment Driven by Efficacy Source: IQVIA R12M as of Nov. 2019 Branded orals include: LATUDA®, REXULTI®, VRAYLAR®, SAPHRIS®, FANAPT®
Slide 11: Advancing a Diversified Pipeline: CNS and Oncology
Advancing a Diversified Pipeline CNS and Oncology
Slide 12: Alkermes' Evolving Research and Development Capabilities
Alkermes’ Evolving Research and Development Capabilities 2000s 2010s 2020 Formulation & Drug Delivery Modifying Existing Small Molecules, Proteins, Peptides LAI Atypical Antipsychotics VIVITROL® BYDUREON® New Molecular Entities Prodrug & NCE Chemistry, Cytokine Engineering ARISTADA® VUMERITY® ALKS 3
Slide 13: Building Fully-Integrated Capabilities Across CNS and Oncology
Building Fully-Integrated Capabilities Across CNS and Oncology CNS Research & Discovery ü Formulation & CMC ü Clinical Trial Operations ü Regulatory Affairs ü Medical Affairs ü Commercial ü Patient Engagement ü Expanding ex-U.S. trial network Evaluating strategic development and commercial partnersh
Slide 14: Research and Development Pipeline: Novel Molecules in High-Potential Therapeutic Areas
Preclinical Phase 1 Phase 2 Phase 3 NDA ALKS 3831 Schizophrenia/ Bipolar I Disorder* ALKS 4230 Immuno-oncology (Intravenous Dosing) Immuno-oncology (Subcutaneous Dosing) IL-10 Fusion Proteins Immuno-oncology Selective HDAC Inhibitors Neurodegenerative Disorders (Orphan) Neurodegenerative Disorders (
Slide 15: Advancing a Diversified Pipeline: Cytokine Platform
Advancing a Diversified Pipeline Cytokine Platform
Slide 16: ALKS 4230: Selective IL-2 Fusion Protein
ALKS 4230: Selective IL-2 Fusion Protein Novel investigational drug designed to leverage proven anti-tumor effects of interleukin-2 (IL-2) pathway Stable, single polypeptide designed to selectively bind to intermediate-affinity IL-2 receptor and expand tumor-killing CD8+ and Natural Killer (NK) T ce
Slide 17: IL-2 Activates and Expands Immune Suppressive Regulatory T Cells
IL-2 Activates and Expands Immune Suppressive Regulatory T Cells That Dampen Anti-Cancer Immune Responses Graphics for illustrative purposes only. b g Intermediate-Affinity Receptor-bearing Cell CD8+ T cell NK cell CD122 CD132 b g a High-Affinity Receptor-bearing Cell Treg cell CD25 CD122 CD132 Figh
Slide 18: ALKS 4230 Designed to Selectively Activate Intermediate-Affinity Receptor
ALKS 4230 Designed to Selectively Activate Intermediate-Affinity Receptor Graphics for illustrative purposes only. ALKS 4230 Design Intention: Preferentially expand cancer-fighting CD8+ T cells and NK cells to potentially improve anti-tumor efficacy Prevent IL-2-derived expansion of Treg cells to mi
Slide 19: Overview of ALKS 4230 Clinical Development Program
Overview of ALKS 4230 Clinical Development Program ARTISTRY-1 Phase 1/2 ARTISTRY-2 Phase 1/2 6-week monotherapy lead-in phase Followed by ALKS 4230 + pembrolizumab combination Evaluating once-weekly and once every three weeks dosing Efficacy expansion phase planned Part A: Monotherapy dose escalatio
Slide 20: Interleukin-10: Concentration-Dependent, Immuno-Regulatory Cytokine
Interleukin-10: Concentration-Dependent, Immuno-Regulatory Cytokine Low concentrations Higher concentrations Tumor-associated macrophage CD8+ T cell CD4+ T cell NK cell B cell Dendritic cell Anti-inflammatory/ Immunosuppressive properties Anti-tumor cytotoxic activity Concentration and dose threshol
Slide 21: Expanding Investigational Cytokine Therapy Portfolio: IL-10 Fusion Proteins
Expanding Investigational Cytokine Therapy Portfolio: IL-10 Fusion Proteins Alkermes’ design objectives: Antibody scaffolding to extend circulating half-life Achieve higher concentrations Reduce dosing frequency Retain anti-tumor functions of IL-10 Fc-mediated activities to provide potential additio
Slide 22: Preclinical Data Demonstrated Anti-Tumor Activity and Potential for Weekly Dosing
Preclinical Data Demonstrated Anti-Tumor Activity and Potential for Weekly Dosing IL-10-Fc fusion proteins* delayed tumor growth and provided a number of complete responses in a murine model of colorectal cancer IL-10-Fc fusion proteins activated CD8+ T cells and reduced regulatory T cells in tumor
Slide 23: Advancing a Diversified Pipeline: Selective HDAC Inhibitors
Advancing a Diversified Pipeline Selective HDAC Inhibitors
Slide 24: Synapses Play a Vital Role in Brain Function
Synapses Play a Vital Role in Brain Function Axon Dendritic Spine Pre-synaptic vesicle Neurotransmitter released into synapse Post-synaptic receptor Synapses are the points of communication within the network of neurons that make up the brain Synaptic function is critical to brain development, learn
Slide 25: Synaptopathies Span Multiple Neurological Diseases Independent of Underlying Pathology
Synaptopathies Span Multiple Neurological Diseases Independent of Underlying Pathology Synaptic loss and dysfunction occur across a wide range of disorders and are associated with clinical symptoms1 Increased synaptic density and function strengthen neuronal connectivity, potentially leading to clin
Slide 26: Loss of Synapses Correlated to Cognitive Decline in Neurodegenerative Patients
Loss of Synapses Correlated to Cognitive Decline in Neurodegenerative Patients Preserved synaptic density observed in cognitively normal patients with underlying Alzheimer’s Disease pathology (CAD) Spine density was similar among control and CAD cases but was reduced significantly in patients with A
Slide 27: Epigenetic Control of Synaptogenesis
Epigenetic Control of Synaptogenesis Acetylation of histones increases accessibility of DNA for transcription of multiple genes associated with synaptogenesis Deacetylation of histones by HDACs (histone deacetylase) causes tight coiling of DNA and closed chromatin leading to gene repression Brain-pe
Slide 28: Extensive Literature Discussing Prosynaptic Effects of HDAC Inhibitors
Extensive Literature Discussing Prosynaptic Effects of HDAC Inhibitors Modulation of long-term memory for object recognition via HDAC inhibition Crebinostat: A Novel Cognitive Enhancer that Inhibits Histone Deacetylase Activity and Modulates Chomatin-Mediated Neuroplasticity Molecular Gene and/or pr
Slide 29: New Chemistry Targets Selective HDAC Complexes
New Chemistry Targets Selective HDAC Complexes Approved HDAC inhibitor compounds have been limited by hematological toxicities, precluding application to chronic neurologic conditions HDACs function in association with multi-protein complexes which determine their activity Alkermes’ proprietary comp
Slide 30: Progress Across Three Key Areas of Optimization of HDAC Inhibitors
Toxicity CoREST Selectivity Brain Penetration Progress Across Three Key Areas of Optimization of HDAC Inhibitors for Synaptopathies Demonstrated significantly improved hematological safety* Selective HDAC-CoREST modulation* activity observed ü ü ü *Fuller et al. ACS Chem. Neurosci. 2019, 10, 1729-17
Slide 31: CoREST Complex-Selective HDAC Inhibitors Showed Prosynaptic Effects and Improved Safety Profile
CoREST Complex-Selective HDAC Inhibitors Showed Prosynaptic Effects and Improved Safety Profile “…novel HDAC inhibitor compounds that selectively inhibit the HDAC−co-repressor of repressor element-1 silencing transcription factor (CoREST) complex while minimizing hematological side effects…selective
Slide 32: Advancing Preclinical Research and IND-Enabling Activities
Advancing Preclinical Research and IND-Enabling Activities HDAC CoREST inhibitors for synaptopathies Pursue IND-enabling activities for lead preclinical compounds Potential utility across highly-prevalent neurodegenerative diseases such as Alzheimer’s Disease as well as orphan diseases such as front
Slide 33: Positioning the Business to Deliver Long-Term Growth and Profitability
Positioning the Business to Deliver Long-Term Growth and Profitability
Slide 34: Positioning Alkermes for Long-Term Growth
Positioning Alkermes for Long-Term Growth Revenue Growth Pipeline Governance Capital Allocation Cost Structure
Slide 35: Positioning Alkermes for Long-Term Growth
Positioning Alkermes for Long-Term Growth VIVITROL® & ARISTADA® : Executing commercial plans VUMERITY®: Received FDA approval; Launched by Biogen ALKS 3831: Submitted NDA and preparing for launch Revenue Growth Governance Pipeline Cost Structure Capital Allocation
Slide 36: Positioning Alkermes for Long-Term Growth
Positioning Alkermes for Long-Term Growth Revenue Growth Governance Pipeline Cost Structure Capital Allocation VIVITROL® & ARISTADA® : Executing commercial plans VUMERITY®: Received FDA approval; Launched by Biogen ALKS 3831: Submitted NDA and preparing for launch Expanded ALKS 4230 program driven b
Slide 37: Positioning Alkermes for Long-Term Growth
Positioning Alkermes for Long-Term Growth Revenue Growth Governance Pipeline Cost Structure Capital Allocation VIVITROL® & ARISTADA® : Executing commercial plans VUMERITY®: Received FDA approval; Launched by Biogen ALKS 3831: Submitted NDA and preparing for launch Expanded ALKS 4230 program driven b
Slide 38: Positioning Alkermes for Long-Term Growth
Positioning Alkermes for Long-Term Growth Revenue Growth Governance Pipeline Cost Structure Capital Allocation VIVITROL® & ARISTADA® : Executing commercial plans VUMERITY®: Received FDA approval; Launched by Biogen ALKS 3831: Submitted NDA and preparing for launch Expanded ALKS 4230 program driven b
Slide 39: Positioning Alkermes for Long-Term Growth
Positioning Alkermes for Long-Term Growth Revenue Growth Governance Pipeline Cost Structure Capital Allocation VIVITROL® & ARISTADA® : Executing commercial plans VUMERITY®: Received FDA approval; Launched by Biogen ALKS 3831: Submitted NDA and preparing for launch Expanded ALKS 4230 program driven b
Slide 40: Positioning Alkermes for Long-Term Growth
Positioning Alkermes for Long-Term Growth Revenue Growth Governance Pipeline Cost Structure Capital Allocation VIVITROL® & ARISTADA®: Executing commercial plans VUMERITY®: Received FDA approval; Launched by Biogen ALKS 3831: Submitted NDA and preparing for launch Expanded ALKS 4230 program driven by
Slide 41: Actively Shaping the Future of the Business
Advancing a diversified CNS and oncology pipeline Positioning the business to deliver long-term growth and profitability Expanding and driving growth of our product portfolio Actively Shaping the Future of the Business
Slide 42: www.alkermes.com
www.alkermes.com
Alkermes — 38th Annual J.P. Morgan Healthcare Conference 2020 on 6ix