Alkermes Plc · NASDAQ:ALKS
Alkermes — 41st Annual J.P. Morgan Healthcare Conference 2023
28 slides from Alkermes's conference presentation, Jan 9, 2023
Slide 1: A Clear Investment Thesis
Richard Pops Chief Executive Officer A Clear Investment Thesis January 2023 41st Annual J.P. Morgan Healthcare Conference 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 expectations with respect t
Slide 3: Alkermes Today
Alkermes Today Proprietary Commercial Products Established Commercial Infrastructure in Complex Markets Royalty & Manufacturing Revenues* Complex Manufacturing Capabilities Neuroscience Development Pipeline Oncology Development Pipeline Neuroscience and Oncology R&D Capabilities *VUMERITY is license
Slide 4: Post-Separation: Clear Value Propositions in Neuroscience and Oncology
Post-Separation: Clear Value Propositions in Neuroscience and Oncology Proprietary Commercial Products Established Commercial Infrastructure in Complex Markets Complex Manufacturing Capabilities Neuroscience R&D Capabilities and Pipeline Oncology Development Pipeline & Capabilities Oncology Company*
Slide 5: Clear Priorities to Unlock Value in 2023
Clear Priorities to Unlock Value in 2023 2023 Business Priorities and Value Drivers Drive launch of LYBALVI® Continued execution of commercial strategy and investment in DTC campaign Advance orexin 2 receptor agonist Establish initial safety and tolerability profile and generate initial clinical pro
Slide 6: Drive Launch of LYBALVI
Drive Launch of LYBALVI®
Slide 7: LYBALVI: Oral Treatment Option for Adults With Schizophrenia or Bipolar I Disorder
LYBALVI® (olanzapine and samidorphan): Oral Treatment Option for Adults With Schizophrenia or Bipolar I Disorder Once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity Commercially launched in U.S. Q4 2021 with diffe
Slide 8: LYBALVI Prescription Growth Trends Reflect Strong Prescriber Breadth
LYBALVI® Prescription Growth Trends Reflect Strong Prescriber Breadth and Diverse Source of Business TRx Week >7,000 prescribers since launch (as of Nov. 30, 2022) bipolar I disorder ~50% other branded and generic antipsychotic therapies olanzapine ~50% schizophrenia ~45% ~55% TRx indication split**
Slide 9: LYBALVI Indications Represent a Large U.S. Opportunity
LYBALVI® Indications Represent a Large U.S. Opportunity Schizophrenia Bipolar I Disorder† Patients (Adults) Monthly Treatment Switches ~2,600,000* ~22,000± 3,100 switches to branded oral agents ~3,900,000 - 5,200,000† ~31,000± 9,700 switches to branded oral agents *Desai et al. J Manag Care Pharm. 2
Slide 10: LYBALVI: Bipolar I Disorder Label Relevant to Real-World Patients
LYBALVI®: Bipolar I Disorder Label Relevant to Real-World Patients Survey question: What Bipolar I disorder symptoms is this patient facing, that you hope to treat with their current therapy regimen? Source: Alkermes Market Survey; Fielded April 29 to June 2, 2022; N=172 HCPs (515 Patient Charts) He
Slide 11: Plans to Launch LYBALVI Direct-to-Consumer Advertising Campaign
Plans to Launch LYBALVI® Direct-to-Consumer Advertising Campaign Focused on Bipolar I Disorder Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LYBALVI is not approved for the treatment of patients with dementia-relat
Slide 12: LYBALVI: Strong Launch Trajectory Established in 2022
LYBALVI®: Strong Launch Trajectory Established in 2022 With Clear Strategic Focus in 2023 LYBALVI Quarterly Net Sales ($M) 2023 Commercial Strategy Focus Breadth: Continue to drive prescriber breadth through highly-targeted field force deployment Access: Expand patient access through continued execu
Slide 13: Advance Orexin Receptor (OX2R) Agonist
Advance Orexin 2 Receptor (OX2R) Agonist
Slide 14: Orexin Dysfunction: Well Defined Opportunity in Narcolepsy and Other Sleep Disorders
Orexin Dysfunction: Well Defined Opportunity in Narcolepsy and Other Sleep Disorders In narcolepsy and other sleep disorders, low orexin levels lead to inconsistent neurotransmitter release, resulting in excessive sleepiness and poor regulation of REM sleep Narcolepsy affects ~200,000 people in U.S.
Slide 15: Leveraging Alkermes' Molecular Design Capabilities to Target Orexin Dysfunction
Leveraging Alkermes’ Molecular Design Capabilities to Target Orexin Dysfunction ALKS 2680 molecular design objectives: Capture performance of endogenous peptide OX2R agonist Increased wakefulness duration Improved cataplexy control Optimize potency and minimize predicted human dose to mitigate risk
Slide 16: Selective OX2R Agonist Showed Increased Wakefulness and Reduced Cataplexy Preclinically
Selective OX2R Agonist Showed Dose-Dependent Increased Wakefulness and Reduced Cataplexy in Preclinical Models Mean ± SEM; One-way ANOVA * = p<0.05, *** = p<0.001 0.1 mg/kg 1 mg/kg 10 mg/kg RDC-264177 0.1 mg/kg 1 mg/kg 10 mg/kg RDC-264177 DTA mouse model of narcolepsy1,2 believed to serve as a predi
Slide 17: Selective Orexin Receptor Agonist Promoted Prolonged Wakefulness in Preclinical Studies
Selective Orexin 2 Receptor Agonist Promoted Prolonged Wakefulness in Preclinical In Vivo Studies Selective orexin 2 receptor agonist demonstrated dose-dependent wake duration (shown by red gamma bands and dark blue theta and delta bands) PharmacoEEG: Pharmaco-electroencephalography Alkermes data on
Slide 18: ALKS 2680: Clinical Development Plan Designed to Rapidly Advance Program in 2023
Single Ascending Dose (Underway) Multiple Ascending Dose POC in Patients (NT1, NT2, IH) and Sleep-Deprived HV ALKS 2680: Clinical Development Plan Designed to Rapidly Advance Program in 2023 Phase 1 First-in-Human Studies (Healthy Volunteers) Phase 1b Proof-of-Concept (POC) Study NT1: Narcolepsy Typ
Slide 19: ALKS 2680 Clinical Development Plan Targeting Proof-of-Concept Data by Year-End 2023
ALKS 2680 Clinical Development Plan Targeting Clinical Proof-of-Concept Data by Year-End 2023 Phase 1b Proof-of-Concept (POC) Study Objective: Early POC data + dose range estimation for phase 2 in lead indications Key Assessments: EEG-based maintenance of wakefulness test as primary efficacy/PD read
Slide 20: Separate Oncology Business
Separate Oncology Business
Slide 21: Post-Separation Oncology Co.: Pure-Play, Development-Stage Oncology Company
Post-Separation Oncology Co. Pure-Play, Development-Stage Oncology Company Investment thesis anchored by potential medical and economic value of nemvaleukin alfa: Potential first-in-class IL-2 variant immunotherapy Anti-tumor activity observed both as a single agent and with checkpoint inhibitors (C
Slide 22: ARTISTRY-1 (IV Nemvaleukin): Durable Responses Observed
ARTISTRY-1 (IV Nemvaleukin): Durable Responses Observed Demonstrated durable responses in high unmet need populations Monotherapy activity (IV) in prior anti-PD-(L)1 treated melanoma and renal cell carcinoma Combination activity (IV) with pembrolizumab in a range of tumor types Treatment-related adv
Slide 23: Nemvaleukin ARTISTRY Development Program
Nemvaleukin ARTISTRY Development Program ARTISTRY-6 Status IDMC: Risk/benefit profile supports study continuation as planned Mucosal melanoma enrollment ongoing Cutaneous cohort (SC) enrollment nearing completion Plan to initiate POC cohort with LFIV dosing (cutaneous) Status Enrollment closed Data
Slide 24: Positioning Alkermes Neuroscience Business for Future Growth
Positioning Alkermes Neuroscience Business for Future Growth
Slide 25: Post-Separation Alkermes: Pure-Play, Commercial-Stage Neuroscience Company
Post-Separation Alkermes* Pure-Play, Commercial-Stage Neuroscience Company Separation expected to enhance profitability Builds on Alkermes’ innovation and excellence in neuroscience *Assuming separation of the company’s oncology business is effected through a spin-off of the oncology business into a
Slide 26: Topline Growth and Diversification Reflect Evolving Business
Topline Growth and Diversification Reflect Evolving Business *Inclusive of ARISTADA INITIO® **Licensed product (royalty & manufacturing revenue) Plan to provide 2023 financial expectations and updated long-term profitability targets in Q1’23
Slide 27: Clear Priorities to Unlock Value in 2023
Clear Priorities to Unlock Value in 2023 2023 Business Priorities and Value Drivers Drive launch of LYBALVI® Continued execution of commercial strategy and investment in DTC campaign Advance orexin 2 receptor agonist Establish initial safety and tolerability profile and generate initial clinical pro
Slide 28: www.alkermes.com
www.alkermes.com
Alkermes — 41st Annual J.P. Morgan Healthcare Conference 2023 on 6ix