Alkermes Plc · NASDAQ:ALKS
Alkermes — 40th Annual J.P. Morgan Healthcare Conference 2022
35 slides from Alkermes's conference presentation, Jan 11, 2022
Slide 1: Alkermes: Advancing Key Business Priorities in 2022
Richard Pops Chief Executive Officer Alkermes: Advancing Key Business Priorities in 2022 January 2022 40th 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: Three Strategic Priorities
Focused on disciplined capital allocation and optimized cost structure Restructured commercial organization to support launch of LYBALVI Initiated nemvaleukin alfa studies in mucosal melanoma and platinum-resistant ovarian cancer to support potential registration Initiated ALKS 1140 phase 1 first-in
Slide 4: 2021 Key Achievements
Focused on disciplined capital allocation and optimized cost structure Restructured commercial organization to support launch of LYBALVI Continued Board of Directors refreshment efforts Appointed two new independent Directors Announced retirement of two longer-serving Directors Initiated declassific
Slide 5: Diversified Biopharmaceutical Company With Proven Capabilities
Phase 1 Neurodegenerative and neurologic disorders Neuroscience Oncology Pipeline of novel development candidates designed to target significant unmet needs Diversified Biopharmaceutical Company With Proven Drug Development and Commercialization Capabilities Licensed to and commercialized by Biogen
Slide 6: Current Growth Drivers
Current Growth Drivers
Slide 7: Commercial Growth Drivers
Commercial Growth Drivers G . ARISTADA ° LYBALVI aripiprazole tauroxil gq Vivitrol ; § VUMERITY™ Simg/t0mg-10mg/0mg-15mg/10mg EZR) 222 m = injectable suspension) 380 mg/vial Ding tiets Glkermes |
Slide 8: LYBALVI: Oral Treatment Option for Schizophrenia or Bipolar I Disorder
LYBALVI®: 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 Indicated for the treatment of: Schizop
Slide 9: LYBALVI: Proven Efficacy With Differentiated Weight Gain Profile
LYBALVI®: Offers Proven Efficacy With a Differentiated Weight Gain Profile in Adult Patients with Schizophrenia LYBALVI offers proven efficacy* and was associated with less weight gain versus olanzapine in patients with schizophrenia in the ENLIGHTEN-2 clinical trial** ENLIGHTEN-1: LYBALVI demonstra
Slide 10: LYBALVI: Sophisticated Commercial Presence in Psychiatry
LYBALVI®: Sophisticated Commercial Presence in Psychiatry Creates Operating & Financial Leverage Commercial Support Infrastructure Marketing Managed markets Patient support services Commercial operations State and Federal policy efforts Commercial Field Organization Psychiatry field sales organizati
Slide 11: LYBALVI: Launch Targeting Focused on Three Prescriber Characteristics
LYBALVI®: Launch Targeting Focused on Three Prescriber Characteristics Across Schizophrenia and BD-1 Alkermes field organization calls on focused healthcare provider universe, prioritized for high-potential prescribers of branded oral antipsychotics Prescribes olanzapine Utilizes branded oral atypic
Slide 12: LYBALVI: Commercial Launch Off to Strong Start
LYBALVI®: Commercial Launch Off to Strong Start Prescription and Prescriber Growth by Week Post Launch† † Source: IQVIA NPA and IQVIA XPO 1 IQVIA reported TRxs (NPA Audit Nov’21 R12M). Unlike olanzapine, LYBALVI contains an opioid antagonist and is contraindicated in persons using opioids. 2Due to d
Slide 13: Commercial Growth Drivers
Commercial Growth Drivers a—ZT - oS - LYBALVI AR SADA RS Vivitrol | © VuMeERITY: ‘5mmg/10mg-10mg/10mg-15 mg/10mg raat = injectable suspension) 380 mg/vial ‘AnglOg tits Glkermes | «
Slide 14: 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 15: ARISTADA: Growth has Outpaced the aLAI Market
ARISTADA®: Growth has Outpaced the aLAI Market *Inclusive of ARISTADA INITIO® TTM (trailing 12 month) data include Q4’20 through Q3’21 net sales results. ARISTADA Net Sales* ($M) Q3 2021 ARISTADA TRx MOT Growth Outpaced Market** **TRx Data: IQVIA NPA data Q3’21; aLAI Market data inclusive of ARISTAD
Slide 16: Commercial Growth Drivers
Commercial Growth Drivers Y re LYBALVI apatites Vivitrol © VuMERITY: 662 = injectable suspension) 380 mg/vial Simg/tOm-l0mg/10mg-15mg/10 mg ‘oma mg tablets Glkermes | +
Slide 17: VIVITROL: LAI for Opioid and Alcohol Dependence
VIVITROL®: LAI for the Treatment of Opioid Dependence and Alcohol Dependence Extended-release opioid antagonist provides therapeutic levels of naltrexone for a one-month period Indicated for the treatment of alcohol dependence (AD) in patients able to abstain from alcohol in an outpatient setting pr
Slide 18: VIVITROL: Sales Fueled by Alcohol Dependence Indication
VIVITROL®: Sales Fueled Increasingly by Alcohol Dependence Indication COVID-19 Impact VIVITROL Net Sales ($M) Growth in Utilization for Alcohol Dependence TTM (trailing 12 month) data include Q4’20 through Q3’21 VIVITROL net sales results. +54% +38% +32% +4% +45% +13%
Slide 19: Commercial Growth Drivers
Commercial Growth Drivers a—ZT - LYBALVI RS Ne Vivitrol | © VuMERITY’ injectable suspension) 380 mey/vial Simg/tOm-l0mg/10mg-15mg/10 mg ‘oma mg tablets Glkermes | +
Slide 20: VUMERITY for Multiple Sclerosis
VUMERITY® (Diroximel Fumarate) for Multiple Sclerosis (MS) Novel oral fumarate for the treatment of relapsing forms of multiple sclerosis Discovered and developed by Alkermes Composition of matter patent extends into 2033
Slide 21: VUMERITY Offers Long-Term Revenue Growth Opportunity
Novel oral fumarate for the treatment of relapsing forms of multiple sclerosis (MS) Approved in U.S. Q4 2019 Biogen holds exclusive, worldwide license to commercialize 15% royalty to Alkermes on worldwide net sales ~$7B oral U.S. MS market* Multiple recent regulatory approvals in Europe VUMERITY® Of
Slide 22: Topline Growth and Diversification Reflect Evolving Business
Topline Growth and Diversification Reflect Evolving Business *Licensed product (royalty & manufacturing revenue) Key product revenues drove 21% 5-year CAGR Commercial launch of LYBALVI® in Q4 2021 provides additional revenue stream TTM (trailing 12 month) data include Q4’20 through Q3’21 net sales r
Slide 23: Innovation Focused on Unmet Patient Need in Neuroscience and Oncology
Innovation Focused on Unmet Patient Need in Neuroscience and Oncology
Slide 24: R&D Objective: Novel Drug Development
R&D Objective: Novel Drug Development With Differentiated and Disciplined Approach Leverage advanced medicinal chemistry and protein engineering capabilities to develop novel molecular entities with strong intellectual property protection Employ integrated approach to target selection, development a
Slide 25: Neuroscience and Oncology Pipeline
Neuroscience and Oncology Pipeline Neuroscience ALKS 1140 Neurology ALKS 2680 Narcolepsy HDAC Inhibitors Neurology/Neuropsychiatry Oncology Nemvaleukin alfa* Platinum-Resistant Ovarian Cancer Nemvaleukin alfa Mucosal Melanoma IL-12 IL-18 HDAC Inhibitors Preclinical Phase 1 Phase 2 Phase 3 Discovery
Slide 26: Nemvaleukin Alfa: Accumulating Data Support Critical Design Criteria
Inherently active, stable fusion protein Nemvaleukin Alfa: Accumulating Data Support Critical Design Criteria Dose-dependent expansion of NK and CD8+ T cells, with minimal effects on Tregs Design Treg: Regulatory T cell; NK cell: Natural killer cell * Also granted FDA Orphan Drug Designation; **In c
Slide 27: Nemvaleukin: Durable and Deepening Responses Observed
Nemvaleukin: Durable and Deepening Responses Observed Demonstrated durable and deepening 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 Designed
Slide 28: Nemvaleukin: Evaluating Multiple Potential Dosing Options
Daily IV x5 Achieved proof-of-concept Demonstrated anti-tumor activity as monotherapy and in combination with pembrolizumab in a range of tumor types Established safety and tolerability profile Advanced into potential registrational studies for difficult-to-treat tumor types with high unmet need Nem
Slide 29: Nemvaleukin: Focused Clinical Program in 2022
Nemvaleukin: Focused Clinical Program in 2022 IV: Intravenous; SC: Subcutaneous; RP2D: Recommended phase 2 dose; ORR: Overall response rate; TME: Tumor microenvironment; MSD: A tradename of Merck & Co., Inc. Kenilworth, NJ, USA ARTISTRY-3 Evaluating efficacy, safety and tolerability of less frequent
Slide 30: ALKS 1140: Novel CoREST-Selective HDAC Inhibitor Candidate
ALKS 1140: Novel CoREST-Selective HDAC Inhibitor Candidate HDAC inhibitors increase accessibility of DNA for transcription of genes associated with synaptogenesis Many neurological disorders are characterized by synaptic pathology Targeting the synapse may slow progression and preserve cognitive and
Slide 31: ALKS 1140: First-in-Human Study Underway
ALKS 1140: First-in-Human Study Underway and Clinical Strategy Focused on Early Validation of Biology ALKS 1140 clinical development program includes early evaluation of prosynaptic mechanism of action First-in-human (FIH), single-ascending dose study underway Phase 0 biomarker research underway and
Slide 32: Targeting Orexin Dysfunction in Narcolepsy
Leveraging Alkermes’ Molecular Design Capabilities to Target Orexin Dysfunction in Narcolepsy In narcolepsy and other sleep disorders, low orexin levels lead to inconsistent neurotransmitter release, resulting in sleep lapses and poor regulation of REM sleep Narcolepsy affects ~200,000 people in U.S
Slide 33: ALKS 2680: Orexin Receptor Agonist
ALKS 2680: Orexin 2 Receptor Agonist ALKS 2680 molecular design objectives for optimization of PK/PD relationship: Mimic potency and performance of endogenous peptide OX2R agonist Increased wakefulness duration Improved cataplexy control Provide convenient dosing Once-daily, oral medication Dose to
Slide 34: Looking Ahead: 2022 Strategic Priorities
Looking Ahead: 2022 Strategic Priorities Execute successful LYBALVI® launch and continue to establish payer access profile Drive growth of VIVITROL® in AD and increase ARISTADA® share of aLAI market Commercial Portfolio Nemvaleukin Early-stage Pipeline Financial Advance enrollment of ARTISTRY-6 & AR
Slide 35: www.alkermes.com
www.alkermes.com
Alkermes — 40th Annual J.P. Morgan Healthcare Conference 2022 on 6ix