Alkermes Plc · NASDAQ:ALKS
Alkermes — 42nd Annual J.P. Morgan Healthcare Conference 2024
29 slides from Alkermes's conference presentation, Jan 8, 2024
Slide 1: Alkermes 2024: Profitable, Pure-play Neuroscience Company
Alkermes 2024: Profitable, Pure-play Neuroscience Company Richard Pops Chief Executive Officer 42nd Annual J.P. Morgan Healthcare Conference January 2024 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 2024: Profitable, Pure-play Neuroscience Company
Alkermes 2024: Profitable, Pure-play Neuroscience Company >$1B commercial business driven primarily by 4 core products* Proven development capabilities with advancing neuroscience pipeline Positioned for sustained profitability and significant cash generation *Based on revenues from VIVITROL®, ARIST
Slide 4: 2023 Accomplishments Enabled Repositioning of Alkermes and Established Strong Foundation for Growth
2023 Accomplishments Enabled Repositioning of Alkermes and Established Strong Foundation for Growth *Based on nine months ended Sept. 30, 2023 compared to the same period in the prior year Generated ALKS 2680 initial clinical proof-of-concept data in patients with narcolepsy type 1 Completed separat
Slide 5: 2024 Strategic Priorities
2024 Strategic Priorities Driven by 4 core products and streamlined operating structure Initiate phase 2 program Advance internal development candidates and explore external pipeline opportunities Deliver strong commercial growth and profitability Advance orexin 2 receptor agonist program Expand neu
Slide 6: >$1B Commercial Business Primarily Driven by Core Products
>$1B Commercial Business Primarily Driven by 4 Core Products
Slide 7: Topline Growth and Diversification Reflect Evolving Business
Topline Growth and Diversification Reflect Evolving Business *Inclusive of ARISTADA INITIO® **Licensed product (royalty & manufacturing revenue) †R12M = Rolling Twelve Months Key Product Revenues ($M) $574 $715 $893 $1,022 †
Slide 8: LYBALVI: Oral Treatment Option for Schizophrenia and Bipolar I Disorder
LYBALVI®: Oral Treatment Option for Schizophrenia and Bipolar I Disorder Once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity Indicated for the treatment of: Schizophrenia in adults Bipolar I disorder in adults Acu
Slide 9: LYBALVI Launch Growth Trends
LYBALVI® Launch Growth Trends *Source: IQVIA NPA Weekly; IQVIA SOB Sep’23 R3M Post-Launch Weekly TRx* (Through 12/22/2023) Week LYBALVI Quarterly Net Sales ($M)
Slide 10: LYBALVI: Long-Term, Open-Label Extension Study Builds on Real World Experience
60% of patients reported an adverse event (AE) Most AEs were mild to moderate in severity Most common AEs reported (>5%) were weight gain, headache, anxiety, insomnia, somnolence, nausea and weight decrease Mean change in Clinical Global Impression of Severity (CGI-S) scale from baseline of -0.28 Me
Slide 11: ARISTADA: LAI for the Treatment of Schizophrenia With Dosing Flexibility
ARISTADA®: LAI for the Treatment of Schizophrenia With Dosing Flexibility *ARISTADA INITIO + single 30 mg oral dose of aripiprazole replaces need for concomitant three weeks of oral aripiprazole for initiation of ARISTADA. The first ARISTADA dose may be administered on the same day as ARISTADA INITI
Slide 12: VIVITROL: LAI for the Treatment of Alcohol Dependence and Opioid Dependence
VIVITROL®: LAI for the Treatment of Alcohol Dependence and Opioid Dependence VIVITROL Annual Net Sales ($M) Extended-release opioid antagonist provides therapeutic levels of naltrexone for a one-month period Indicated for the treatment of alcohol dependence (AD) in patients able to abstain from alco
Slide 13: VUMERITY Offers Long-Term Revenue Growth Opportunity
VUMERITY® Offers Long-Term Revenue Growth Opportunity VUMERITY Royalty & Manufacturing Revenue ($M) $23 $87 $115 $128 Novel oral fumarate for the treatment of relapsing forms of multiple sclerosis (MS) Biogen holds exclusive, worldwide license to commercialize 15% royalty to Alkermes on worldwide ne
Slide 14: Proven Drug Development Capabilities with Advancing Neuroscience Pipeline
Proven Drug Development Capabilities with Advancing Neuroscience Pipeline
Slide 15: Proven Neuroscience Drug Development Capabilities
Proven Neuroscience Drug Development Capabilities Enabled by established capabilities in: Neuroscience drug development expertise has yielded multiple commercial products: Molecular Design Medicinal Chemistry Translational Medicine Clinical Development Regulatory Science Medical Affairs VUMERITY is
Slide 16: Orexin Dysfunction: Well Defined Opportunity in Narcolepsy and Other Sleep Disorders
Orexin Dysfunction: Well Defined Opportunity in Narcolepsy and Other Sleep Disorders In narcolepsy, low orexin levels lead to inconsistent neurotransmitter release, resulting in excessive sleepiness and poor regulation of REM sleep Narcolepsy (types 1 and 2) affects ~200,000 people in U.S. and 3M pe
Slide 17: OX2R: Molecular Design Challenge and Optimization Parameters
OX2R: Molecular Design Challenge and Optimization Parameters
Slide 18: OX2R: Molecular Design Challenge and Optimization Parameters
OX2R: Molecular Design Challenge and Optimization Parameters Potential pharmaceutical profiles are for illustrative purposes only and do not represent any specific development candidate
Slide 19: OX2R: Molecular Design Challenge and Optimization Parameters
OX2R: Molecular Design Challenge and Optimization Parameters ALKS 2680 Investigational oral orexin 2 receptor agonist for the treatment of narcolepsy designed for: Improved wakefulness duration and quality PK/PD profile that mirrors natural sleep/wake cycle Cataplexy control Low therapeutic dose wit
Slide 20: ALKS 2680: Investigational Oral Orexin Receptor Agonist for the Treatment of Narcolepsy
ALKS 2680: Investigational Oral Orexin 2 Receptor Agonist for the Treatment of Narcolepsy CONFIDENTIAL. NOT FOR DISSEMINATION. OX1R: orexin 1 receptor; OX2R: orexin 2 receptor; PK: pharmacokinetic; NT1: narcolepsy type 1; NT2: narcolepsy type 2; IH: idiopathic hypersomnia ALKS 2680 is a highly poten
Slide 21: ALKS 2680: First-in-Human Data Presented at 2023 World Sleep Meeting
ALKS 2680: First-in-Human Data Presented at 2023 World Sleep Meeting Single- and multiple- ascending dose study safety and tolerability data (n=80) Initial proof-of-concept data in patients with Narcolepsy Type 1 (n=4)
Slide 22: ALKS 2680: Results From Full NT1 Cohort Support Advancement to Phase 2
ALKS 2680: Results From Full NT1 (n=10) Cohort Support Advancement to Phase 2 Efficacy Statistically significant and clinically meaningful improvement of maintenance of wakefulness test (MWT) scores at each dose level (1 mg, 3 mg, 8 mg) Dose-dependent magnitude and durability of effect Dose range fo
Slide 23: ALKS 2680: Advancing Into Phase 2 in 2024
ALKS 2680: Advancing Into Phase 2 in 2024 Planned Narcolepsy Type 1 Phase 2 Design
Slide 24: Phase 2 Designed to Capture Standard Endpoints and Exploratory Measures
Phase 2 Designed to Capture Standard Endpoints and Exploratory Measures Planned Primary and Secondary Assessments Maintenance of Wakefulness Test (MWT) Change from baseline in average sleep latency on MWT over 8 hours 40-minute EEG-based test administered every two hours Epworth Sleepiness Scale Wid
Slide 25: Building a Neuroscience Development Pipeline That Leverages Alkermes' Capabilities
Building a Neuroscience Development Pipeline That Leverages Alkermes’ Capabilities Orexin 2 pathway activation Narcolepsy Other excessive daytime sleepiness disorders Other neuropsychiatric disorders Other internal neuroscience candidates Psychiatry and neurology Chemistry and preclinical evaluation
Slide 26: Positioned for Sustained Profitability and Significant Cash Generation
Positioned for Sustained Profitability and Significant Cash Generation
Slide 27: Commercial Performance and Efficient Cost Structure Expected to Drive Meaningful Profitability
Commercial Performance and Efficient Cost Structure Expected to Drive Meaningful Profitability 2024 Key Financial Expectations: Revenues Continued growth of proprietary commercial products revenue INVEGA SUSTENNA® U.S. royalty expiration in August 2024 Operating Expenses R&D expense savings of ~$150
Slide 28: 2024 Strategic Priorities
2024 Strategic Priorities Driven by 4 core products and streamlined operating structure Initiate phase 2 program Advance internal development candidates and explore external pipeline opportunities Deliver strong commercial growth and profitability Advance orexin 2 receptor agonist program Expand neu
Slide 29: www.alkermes.com
www.alkermes.com © 2024 Alkermes. All rights reserved.
Alkermes — 42nd Annual J.P. Morgan Healthcare Conference 2024 on 6ix