Alkermes Plc · NASDAQ:ALKS
Alkermes — 43rd Annual J.P. Morgan Healthcare Conference (January 2025)
25 slides from Alkermes's conference presentation, January 2025
Slide 1: Alkermes 2025
Alkermes 2025 Richard Pops Chief Executive Officer 43rd Annual J.P. Morgan Healthcare Conference January 2025
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 Value Proposition: Opportunity for Significant Value Creation in 2025
Alkermes Value Proposition: Opportunity for Significant Value Creation in 2025 Profitable business driven by ALKS 2680 1 proprietary commercial products phase 2 data expected in 2025: Leader in one of the most exciting Randomized, 2 development spaces within neuroscience placebo-controlled, multi-we
Slide 4: Highly Profitable, Self-Funding Business With Strong Balance Sheet
Highly Profitable, Self-Funding Business With Strong Balance Sheet >$1B of proprietary >$200M of EBITDA* ~$825M in cash product net sales expected in 2025 and investments expected in 2025 at 12/31/24 Non-dilutive funding for Ongoing commitment Strong financial position and development pipeline to ef
Slide 5: Extensive Experience Developing Small Molecule CNS Medicines
Extensive Experience Developing Small Molecule CNS Medicines Experience and established capabilities • Dosage form design • Clinical development * ** • Regulatory strategy • Commercial positioning CNS: Central nervous System *Inclusive of ARISTADA INITIO® **Licensed product (royalty & manufacturing
Slide 6: Advancing Neuroscience Pipeline in Hypersomnolence Disorders and Beyond
Advancing Neuroscience Pipeline in Hypersomnolence Disorders and Beyond
Slide 7: Central Disorders of Hypersomnolence: Narcolepsy and Idiopathic Hypersomnia
Central Disorders of Hypersomnolence: Narcolepsy and Idiopathic Hypersomnia Distinguishing Clinical Features of Distribution of Sleep Stages Hypersomnolence Disorders Over a 24-Hour Period: Narcolepsy type 1 (NT1) Healthy Sleepers Narcoleptic Sleepers Excessive daytime sleepiness with cataplexy, MID
Slide 8: High Unmet Need: Narcolepsy and Idiopathic Hypersomnia in the U.S.
High Unmet Need: Narcolepsy and Idiopathic Hypersomnia in the U.S. Narcolepsy 200,000 prevalencea 100,000 diagnosedb NT1: ~30% NT2: ~70% A recent survey was conducted in the United States with the aim of sharing patients’ perspectives on Idiopathic Hypersomnia the treatment of narcolepsy…95% of resp
Slide 9: Orexin System is the Master Regulator of Wakefulness
Orexin System is the Master Regulator of Wakefulness • Orexin (hypocretin), a neuropeptide produced in the hypothalamus, is the master regulator of wakefulness* • Decreased orexin signaling leads to excessive daytime sleepiness associated with narcolepsy • Narcolepsy type 1 is characterized by the l
Slide 10: Orexin 2 Receptor Agonists: Transformative Potential in Hypersomnolence Disorders
Orexin 2 Receptor Agonists: Transformative Potential in Hypersomnolence Disorders Orphan indications: ~140,000 diagnosed* Limited number of narcolepsy & IH competitive candidates patients in the U.S. in development Potential to evolve Concentrated Multi-billion standard of care by prescriber univers
Slide 11: ALKS 2680: Differentiated Orexin 2 Receptor Agonist Advancing With Robust Phase 2 Dataset Expected
ALKS 2680: Differentiated Orexin 2 Receptor Agonist Advancing With Robust Phase 2 Dataset Expected in 2025 Data in patients across NT1, NT2 and IH • Phase 1b demonstrated normalization* of wakefulness with once-daily dosing • FDA Fast Track designation for narcolepsy Designed to have a strong compet
Slide 12: ALKS 2680 Development Strategy Designed to Support Regulatory Approval and Competitive Positioning
ALKS 2680 Development Strategy Designed to Support Regulatory Approval and Competitive Positioning Chemical design Clinical proof-of-concept Confirmatory clinical data in patients development studies (multi-week, phase 2/3 ) Potency Proof-of-concept endpoints: Regulatory endpoints: MWT, Maintenance
Slide 13: ALKS 2680 Phase 1b: Wide Therapeutic Index With Generally Well-Tolerated Profile at All Doses
ALKS 2680 Phase 1b: Wide Therapeutic Index With Generally Well-Tolerated Profile at All Doses Tested in NT1, NT2 and IH • Most TEAEs were mild in severity and transient • o serious or severe EAEs, or EAEs leading to discontinuation • Treatment-related TEAEs* reported in >1 subject in each populati
Slide 14: ALKS 2680 Phase 1b: Meaningful, Consistent and Dose-Dependent Effect on Wakefulness
ALKS 2680 Phase 1b: Demonstrated Meaningful, Consistent and Dose-Dependent Effect on Wakefulness in NT1, NT2 & IH Patients Absolute Mean Sleep Latency on Maintenance of Wakefulness Test (MWT) - Mean SE Narcolepsy Type 1 (n = 10) Narcolepsy Type 2 (n = 9) Idiopathic Hypersomnia (n = 8) 40 30 Minute
Slide 15: ALKS 2680 Phase 2 Clinical Program Evaluating Once-Daily Administration in Narcolepsy
ALKS 2680 Phase 2 Clinical Program Evaluating Once-Daily Administration in Narcolepsy Type 1 and Type 2 Double-blind treatment (6-week or 8-week) Randomization ALKS 2680 dose 1 (n=20) ALKS 2680 dose 2 (n=20) Washout Open-label extension Safety follow-up ALKS 2680 dose 3 (n=20) With dose adjustment o
Slide 16: Robust Phase 2 Design Incorporates Elements to Support Phase 3, Registration, Commercial Positioning
Robust Phase 2 Design Incorporates Elements to Support Phase 3, Registration, Commercial Positioning • Sample size and duration. Robust dataset to capture patient variability, durability of effect and multi-week safety • Incorporates regulatory feedback. Placebo-controlled, double-blind, multi-dose,
Slide 17: Orexin System Modulates Diverse Neuronal Functions Beyond Wakefulness
Orexin System Modulates Diverse Neuronal Functions Beyond Wakefulness Orexin pathway Originates in hypothalamus and engages distributed neuronal circuitry Prefrontal Cortex Promotes adaptive behavioral responses TH BF Hypothalamus Hippocampus NAc SN/VTA TMN AM DR AM: amygdala; BF: basal forebrain; D
Slide 18: Orexin System Modulates Diverse Neuronal Functions Beyond Wakefulness
Orexin System Modulates Diverse Neuronal Functions Beyond Wakefulness Orexin pathway Originates in hypothalamus and engages distributed neuronal circuitry Prefrontal Cortex Promotes adaptive behavioral responses TH BF Hypothalamus Attention Pathway Hippocampus Cortical, sensory, and basal ganglia NA
Slide 19: Orexin System Modulates Diverse Neuronal Functions Beyond Wakefulness
Orexin System Modulates Diverse Neuronal Functions Beyond Wakefulness Orexin pathway Originates in hypothalamus and engages distributed neuronal circuitry Prefrontal Cortex Promotes adaptive behavioral responses TH BF Hypothalamus Hippocampus NAc SN/VTA TMN AM DR AM: amygdala; BF: basal forebrain; D
Slide 20: Orexin System Modulates Diverse Neuronal Functions Beyond Wakefulness
Orexin System Modulates Diverse Neuronal Functions Beyond Wakefulness Orexin pathway Originates in hypothalamus and engages distributed neuronal circuitry Prefrontal Cortex Promotes adaptive behavioral responses TH BF Hypothalamus Hippocampus Mood Pathway Cortical and limbic circuitry receives NAc S
Slide 21: Preclinical Data Support Expanding Orexin Receptor Agonist Program
Preclinical Data Support Expanding Orexin 2 Receptor Agonist Program: New Molecules in Additional Disease States • Validated preclinical models provide translational value and enable data-driven decision making • Orexin 2 receptor agonism demonstrated significant effects across prefrontal cortical n
Slide 22: Orexin Receptor Agonists May Have Potential Applicability in Broad Range of CNS Diseases
Orexin 2 Receptor Agonists May Have Potential Applicability in Broad Range of CNS Diseases Beyond Sleep Disorders: Disease states with key clinical aspects that may be modulated by the orexin pathway Ultra Orphan Orphan High Prevalence Diseases Diseases Diseases <5,000 patients 5,000 - 200,000 patie
Slide 23: Advancing Multiple Orexin Development Candidates for Treatment of CNS Disorders
Advancing Multiple Orexin Development Candidates for Treatment of CNS Disorders Next Expected Discovery Preclinical Phase 1 Phase 2 Phase 3 Milestone ALKS 2680 Narcolepsy Type 1 Phase 2 data H2 2025 Narcolepsy Type 2 Phase 2 data H2 2025 Idiopathic Hypersomnia Phase 2 initiation H1 2025 Project Satu
Slide 24: Alkermes Value Proposition: Opportunity for Significant Value Creation in 2025
Alkermes Value Proposition: Opportunity for Significant Value Creation in 2025 Profitable business driven by ALKS 2680 1 proprietary commercial products phase 2 data expected in 2025: Leader in one of the most exciting Randomized, 2 development spaces within neuroscience placebo-controlled, multi-we
Slide 25: www.alkermes.com
www.alkermes.com © 2025 Alkermes. All rights reserved.
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