Slide 1: Third Quarter 2023 Financial Results & Business Update
Third Quarter 2023 Financial Results & Business Update October 25, 2023 © 2023 2021 Alkermes. All rights reserved.
Slide 2: Forward-Looking Statements and Non-GAAP Financial Information
Forward-Looking Statements and Non-GAAP Financial Information 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: Alkerm
Slide 3: Q3 2023 Financial Performance
Q3 2023 Financial Performance
Slide 4: Q3 2023 Financial Results Summary
Q3 2023 Financial Results Summary Total Revenue* GAAP Net Income (Loss) Non-GAAP Net Income** In millions In millions In millions $380.9 $252.4 $109.5 $47.8 ($64.0) $3.5 Q3 2022 Q3 2023 Q3 2022 Q3 2023 Q3 2022 Q3 2023 *Reflects reinstatement of certain U.S. royalties following the successful outcome
Slide 5: Q3 2023 Revenue Summary
Q3 2023 Revenue Summary ∆ In millions, except % Q3’23 Q3’22 Q3’23 vs. Q3’22 Total Proprietary Net Sales $231.8 $199.4 16% VIVITROL® $99.3 $96.5 3% ARISTADA®* $81.8 $75.7 8% LYBALVI®† $50.7 $27.1 87% Manufacturing & Royalty Revenue** $149.1 $52.9 182% Research & Development Revenue $0.0 $0.0 - Total
Slide 6: Alkermes: 2023 Financial Expectations
Alkermes: 2023 Financial Expectations1 (in millions, except per share amounts) Financial Expectations for Year Total Revenues Breakdown: Ending Dec. 31, 2023 • Expected net sales of proprietary products: Total Revenues $1,550 – $1,680 o VIVITROL® net sales of $380M – $410M COGS $230 – $250 o ARISTAD
Slide 7: Q3 2023 Commercial Review
Q3 2023 Commercial Review
Slide 8: Topline Growth and Diversification Reflect Evolving Business
Topline Growth and Diversification Reflect Evolving Business Key Product Revenues ($M) $1,200 $1,000 $800 $600 $400 $200 $0 FY'18 FY'19 FY'20 FY'21 FY'22 Q3'23 R12M VIVITROL® ARISTADA®* VUMERITY®** LYBALVI® *Inclusive of ARISTADA INITIO® **Licensed product (royalty & manufacturing revenue) R12M = Ro
Slide 9: LYBALVI Performance and Expectations
LYBALVI® Performance and Expectations LYBALVI Quarterly Net Sales ($M) Q3’23 net sales of $50.7M reflect 8% sequential $50 growth compared to Q2’23 • Q3’23 gross-to-net deductions: ~25% $40 $30 Outlook: • FY’23 net sales expected to range from $20 $180M – $205M* $10 $0 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22
Slide 10: LYBALVI Prescription Growth Trends
LYBALVI® Prescription Growth Trends Post-Launch TRx* (Through 10/13/23) Q3’23 total TRx: 4,000 • ~41,800 reflecting 10% 3,500 sequential growth compared 3,000 to Q2’23 2,500 TRx 2,000 1,500 1,000 500 0 1 5 9 13 17 21 25 29 33 37 41 45 49 53 57 61 65 69 73 77 81 85 89 93 97 101 By Week 4 Week Rolling
Slide 11: ARISTADA Performance and Expectations
ARISTADA® Performance and Expectations ARISTADA Quarterly Net Sales ($M)* $90 Q3’23 year-over-year net sales increased 8% to $81.8M $80 $70 Outlook: • FY’23 net sales expected to range from $60 $315M – $345M†* $50 $40 $30 $20 $10 $0 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 *Inclusive of ARISTADA IN
Slide 12: VIVITROL Performance and Expectations
VIVITROL® Performance and Expectations VIVITROL Quarterly Net Sales ($M) $120 Q3’23 year-over-year net sales increased 3% to $99.3M $100 Outlook: $80 • FY’23 net sales expected to range from $380M – $410M* $60 $40 $20 $0 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 *These expectations were initially pr
Slide 13: Preliminary Results from a Phase 1 Study of ALKS 2680
Preliminary Results from a Phase 1 Study of ALKS 2680, an Orexin 2 Receptor Agonist, in Healthy Participants and Patients with Narcolepsy or Idiopathic Hypersomnia World Sleep Congress | October 23, 2023
Slide 14: ALKS 2680 Is an Investigational Oral Orexin 2 Receptor Agonist for Narcolepsy
ALKS 2680 Is an 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 n
Slide 15: 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 • 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 pharmacodynamic
Slide 16: ALKS 2680 Was Generally Well Tolerated in Healthy Volunteers
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 an
Slide 17: ALKS 2680 Achieved Desired Pharmacokinetic Profile With Once-Daily Dosing
Healthy Volunteers ALKS 2680 Achieved Desired Pharmacokinetic Profile With Once-Daily Dosing 10000 Systemic Exposure (AUC) • Overall PK profile supports once-daily dosing 1000 ◦ Mimics natural sleep/wake cycle ng*h/mL AUC ◦ Half life = 8-10 hours 100 10 • Wide safety margin Proportional increase wit
Slide 18: First-in-Human Study of ALKS 2680 in Patients With NT1
NT1 Patients Ongoing Randomized, Double-Blind, Placebo-Controlled First-in-Human Study of ALKS 2680 in Patients With NT1 • 1:1:1:1 randomization in a 4-way cross-over design n=1 • Up to 8 patients per cohort n=1 N=4 ◦ First 4 patients in the NT1 cohort n=1 completed n=1 • Objectives: ◦ Safety and to
Slide 19: Demographics and Baseline Characteristics
NT1 Patients Demographics and Baseline Characteristics Demographic Characteristic Total (N=4) Age, years, mean (SD) 23.5 (6.40) Female, n (%) 1 (25) White Race, n (%) 4 (100) Body Mass Index, kg/m2, mean (SD) 30.5 (5.45) Baseline Disease Severity Total (N=4) Narcolepsy Severity Scale, mean (SD) 39.8
Slide 20: Single Doses of ALKS 2680 Were Generally Well Tolerated
NT1 Patients Single Doses of ALKS 2680 Were Generally Well Tolerated Placebo ALKS 2680 1 mg 3 mg 8 mg n=4 n=4 n=4 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 increas
Slide 21: ALKS 2680 Significantly Improved Sleep Latency With a Clear Dose Response
NT1 Patients ALKS 2680 Significantly Improved Sleep Latency With a Clear Dose Response Average Sleep Latency on the Maintenance of Wakefulness Test (MWT) (N = 4 per dose) P < 0.001 Change from Baseline in Average Sleep Latency on MWT Over 8 Hours, Least Squares Mean (95% CI), Minutes 40 P < 0.001 35
Slide 22: ALKS 2680 Single Dose Time Course Suggests a Therapeutic Dose Between 3 mg and 8 mg
NT1 Patients ALKS 2680 Single Dose Time Course Suggests a Therapeutic Dose Between 3 mg and 8 mg in NT1 Maintenance of Wakefulness Test (MWT) Maximum test duration = 40 min 40 35 Pre-dose Mean ± SE, Minutes 30 Placebo Sleep Latency ALKS 2680 1 mg 25 ALKS 2680 3 mg 20 ALKS 2680 8 mg 15 10 5 0 -8 2 -6
Slide 23: Conclusions
Conclusions Initial benefit/risk profile supports continued clinical evaluation of ALKS 2680 ALKS 2680 in Generally well tolerated up to doses of 50 mg Healthy Volunteers Increased objective and subjective measures of alertness (N = 80) PK/PD profile supports once-daily oral dosing ALKS 2680 in Gene
Slide 24: Appendix
Appendix
Slide 25: Appendix: Financial Results GAAP to Non-GAAP Adjustments
Appendix: Financial Results GAAP to Non-GAAP Adjustments Three Months Ended (In millions) September 30, 2023 Net Income — GAAP $ 47.8 Adjustments: Share-based compensation expense 23.9 Depreciation expense 9.7 Amortization expense 9.0 Separation expense 9.6 Restructuring expense 5.9 Income tax effec
Slide 26: Appendix: 2023 Guidance GAAP to Non-GAAP Adjustments
Appendix: 2023 Guidance GAAP to Non-GAAP Adjustments Year Ending Earnings Per (In millions, except per share data) December 31, 2023 Shares+ Share Projected Net Income — GAAP $ 245.0 171.5 $ 1.43 Adjustments: Share-based compensation expense 97.5 Depreciation expense 42.5 Amortization expense 35.0 S
Slide 27: www.alkermes.com
www.alkermes.com © 2023 2021 Alkermes. All rights reserved.