Alkermes Plc · NASDAQ:ALKS
Alkermes — Investor Presentation (November 2023)
28 slides from Alkermes's investor presentation, Nov 15, 2023
Slide 1: Alkermes Corporate Presentation November 2023
Alkermes Corporate Presentation November 2023 Exhibit 99.2
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: Post-Separation: Clear Value Proposition in Neuroscience
Post-Separation: Clear Value Proposition in Neuroscience Proprietary Commercial Products Established Commercial Infrastructure in Complex Markets Complex Manufacturing Capabilities Neuroscience R&D Capabilities and Pipeline Royalty & Manufacturing Revenues
Slide 4: Key 2023 Accomplishments
Key 2023 Accomplishments Completed separation of the oncology business 1 DTC: Direct-to-consumer Presented initial proof-of-concept data from phase 1b trial of ALKS 2680 in patients with narcolepsy type 1 2 Successfully settled VIVITROL® patent litigation 3 Prevailed in Janssen arbitration; Raised 2
Slide 5: Commercial Portfolio
Commercial Portfolio
Slide 6: 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 7: LYBALVI Prescription Growth Trends Reflect Strong Prescriber Breadth
LYBALVI® Prescription Growth Trends Reflect Strong Prescriber Breadth and Diverse Source of Business ~12,700 prescribers since launch (as of Sept. 30, 2023) bipolar I disorder ~48% other branded and generic antipsychotic therapies olanzapine ~52% schizophrenia ~45% ~55% TRx indication split**: Patie
Slide 8: 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* ~25,000± 2,400 switches to branded oral agents ~3,900,000 - 5,200,000† ~34,000± 7,400 switches to branded oral agents *Desai et al. J Manag Care Pharm. 2
Slide 9: 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) 13
Slide 10: Launched LYBALVI TV Direct-to-Consumer Advertising Campaign
Launched LYBALVI® TV Portion of Direct-to-Consumer Advertising Campaign Focused on Bipolar I Disorder in May 2023 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
Slide 11: LYBALVI: Strong Launch Trajectory With Clear Strategic Focus in 2023
LYBALVI®: Strong Launch Trajectory Established in 2022 With Clear Strategic Focus in 2023 2023 Commercial Strategy Focus Breadth: Continue to drive prescriber breadth through highly-targeted field force deployment Access: Expand patient access through continued execution of disciplined payer contrac
Slide 12: ARISTADA: LAI for Schizophrenia With Dosing Flexibility
ARISTADA®: LAI for Schizophrenia With Dosing Flexibility 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 Ability to fully dose on day one for up to two months wi
Slide 13: VIVITROL: LAI for Opioid Dependence and Alcohol Dependence
VIVITROL®: LAI for the Treatment of Opioid Dependence and Alcohol Dependence 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 alcohol in an outpatient setting pr
Slide 14: VUMERITY Offers Long-Term Revenue Growth Opportunity
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 net sales Discovered and developed by Alkermes Composition of matter patent extends into 2033* VUMERITY® Offers Long-Ter
Slide 15: 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)
Slide 16: ALKS 2680: Orexin Receptor (OX2R) Agonist
ALKS 2680: Orexin 2 Receptor (OX2R) Agonist
Slide 17: 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 18: ALKS 2680: Investigational Oral Orexin Receptor Agonist for Narcolepsy
ALKS 2680: Investigational Oral Orexin 2 Receptor Agonist for the Treatment of Narcolepsy ALKS 2680 is a highly potent, orally bioavailable, selective OX2R agonist ≥10 fold more potent than orexin Aa >5,000-fold selectivity relative to OX1Ra Designed to address underlying pathology of narcolepsy and
Slide 19: First-in-Human Study of ALKS 2680: SAD and MAD Healthy Volunteers
Ongoing Randomized, Double-Blind, Placebo-Controlled First-in-Human Study of ALKS 2680: SAD and MAD Healthy Volunteers Each dose cohort in both SAD and MAD included 8 new participants 6 on ALKS 2680, 2 on placebo Objectives: Safety and tolerability Pharmacokinetics (PK) and pharmacodynamics (PD) *De
Slide 20: ALKS 2680 Was Generally Well Tolerated in Healthy Volunteers
ALKS 2680 Was Generally Well Tolerated in Healthy Volunteers in Both SAD and MAD Maximum tolerated dose not reached Most AEs were mild and observed at doses ≥15 mg (SAD) and ≥8 mg (MAD) No severe AEs or serious adverse events (SAEs) were reported Most AEs were transient and resolved without interven
Slide 21: First-in-Human Study of ALKS 2680 in Patients With NT1
Ongoing Randomized, Double-Blind, Placebo-Controlled First-in-Human Study of ALKS 2680 in Patients With NT1 NT2 and IH patient cohorts are currently being evaluated at higher doses 1:1:1:1 randomization in a 4-way cross-over design Up to 8 patients per cohort First 4 patients in the NT1 cohort compl
Slide 22: Single Doses of ALKS 2680 Were Generally Well Tolerated
Placebo ALKS 2680 Preferred Term n=4 1 mg n=4 3 mg n=4 8 mg n=4 Adverse events (AEs) reported as related to study drug, n (%) 0 0 0 4 (100) Insomnia 0 0 0 3 (75) Pollakiuria 0 0 0 2 (50) Salivary hypersecretion 0 0 0 2 (50) Blood pressure increased 0 0 0 1 (25) Bruxism 0 0 0 1 (25) Dizziness 0 0 0 1
Slide 23: ALKS 2680 Significantly Improved Sleep Latency With a Clear Dose Response
ALKS 2680 Significantly Improved Sleep Latency With a Clear Dose Response NT1 Patients Change from Baseline in Average Sleep Latency on MWT Over 8 Hours, Least Squares Mean (95% CI), Minutes ALKS 2680 Dose P < 0.001 Average Sleep Latency on the Maintenance of Wakefulness Test (MWT) (N = 4 per dose)
Slide 24: ALKS 2680 Single Dose Time Course Suggests Therapeutic Dose Between 3 mg and 8 mg
ALKS 2680 Single Dose Time Course Suggests a Therapeutic Dose Between 3 mg and 8 mg in NT1 NT1 Patients Sleep Latency Mean ± SE, Minutes Maximum test duration = 40 min Day 1 (Post-dose), Hours Maintenance of Wakefulness Test (MWT) 2 4 6 8 Day -1 (Baseline), Hours Dosing 0 NT1: narcolepsy type 1
Slide 25: Conclusions
Conclusions ALKS 2680 in Generally well tolerated up to doses of 50 mg Increased objective and subjective measures of alertness PK/PD profile supports once-daily oral dosing ALKS 2680 in Generally well tolerated at all doses tested; drug-related adverse events only observed at highest dose (8 mg) St
Slide 26: Positioning Alkermes Neuroscience Business for Future Growth
Positioning Alkermes Neuroscience Business for Future Growth
Slide 27: Post-Separation Alkermes: Pure-Play, Commercial-Stage Neuroscience Company
Post-Separation Alkermes: Pure-Play, Commercial-Stage Neuroscience Company Proprietary Products Topline primarily driven by growth of proprietary commercial products in addiction and psychiatry Complex manufacturing capabilities Development Pipeline Early-stage neuroscience pipeline ALKS 2680, orexi
Slide 28: www.alkermes.com
www.alkermes.com © 2023 Alkermes. All rights reserved.