Slide 1: First Quarter 2019 Financial Results & Business Update
First Quarter 2019 Financial Results & Business Update April 25, 2019 Exhibit 99.2
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: the co
Slide 3: First Quarter Earnings Call Agenda
First Quarter Earnings Call Agenda Q1 2019 Financial Results Jim Frates Chief Financial Officer Pipeline and R&D Update Craig Hopkinson Chief Medical Officer Business Update Richard Pops Chief Executive Officer
Slide 4: First Quarter 2019 Revenue Summary
First Quarter 2019 Revenue Summary In millions, except % Q1’19 Q1’18 ∆ Q1’19 vs. Q1’18 VIVITROL® $69.2 $62.7 10% ARISTADA® $30.3 $29.2 4% Manufacturing & Royalty Revenues $108.9* $114.6 (5%) R&D Revenues $14.7 $18.7 (21%) Total Revenues $223.1 $225.2 (1%) *These results reflect a $17.9 million decli
Slide 5: Revenues From Proprietary Commercial Medicines
Revenues From Proprietary Commercial Medicines Proprietary Commercial Product Net Sales ($M)
Slide 6: VIVITROL Performance
VIVITROL® Performance Q1 year-over-year net sales growth of 10%, driven by underlying unit growth of 8% Gross-to-net deductions of 49% in Q1’19, compared to 46% in Q4’18 and 50% in Q1’18 Sequential decrease in net sales driven by seasonal inventory fluctuations Inventory drawdown of ~$5M in quarter
Slide 7: ARISTADA Performance
Q1 year-over-year net sales growth of 4% Gross-to-net deductions of 49%, compared to 44% in Q4’18 and 43% in Q1’18 Sequential decrease in net sales driven by seasonal inventory fluctuations Inventory drawdown of ~$10M in quarter Total prescriptions increased by 5% sequentially during the quarter1 20
Slide 8: Alkermes: 2019 Financial Expectations
(in millions, except per share amounts) Financial Expectations for Year Ending Dec. 31, 2019† Revenues $1,140 – 1,190 COGS $180 – 190 R&D Expense $450 – 480 SG&A Expense $590 – 620 Amortization of Intangible Assets ~$40 Net Interest Expense $5 to $10 Income Tax Expense $10 to $15 GAAP Net Loss $(135
Slide 9: VIVITROL: Opportunities to Increase Utilization and Drive Growth
Federal grant dollars related to 21st Century Cures and SUPPORT for Patients and Communities Acts continue to be allocated Funding slowly flowing into fragmented treatment system States have adopted more targeted policies in criminal justice and community settings, and have passed legislation to rem
Slide 10: ARISTADA: Potential New Growth Drivers
Commercial organization expansion completed in Q1’19 60 new community and hospital-based sales representatives recently onboarded Positive topline results from ALPINE study demonstrated efficacy, safety and tolerability of both ARISTADA and the current market-leader, INVEGA SUSTENNA ® Plan to publis
Slide 11: ALKS 3831: ENLIGHTEN-2 and Interim Results From Ongoing ENLIGHTEN-2-EXT
© 2019 Alkermes. All rights reserved. ALKS 3831: ENLIGHTEN-2 and Interim Results From Ongoing ENLIGHTEN-2-EXT Open-Label Safety Study
Slide 12: ENLIGHTEN-2: Achieved Prespecified Co-Primary and Key Secondary Endpoints
ENLIGHTEN-2: Achieved Prespecified Co-Primary and Key Secondary Endpoints p=0.003 p=0.001 p=0.003 Mean Weight Gain at Week 24 Proportion of Subjects Gaining Clinically Meaningful Weight at Week 24 6.59% 4.21% 17.8% 29.8% 27.5% 42.7% Mean Percent Change From Baseline in Body Weight (%) Proportion of
Slide 13: ENLIGHTEN-2: Weight Gain Trajectory of Early Discontinuations
ENLIGHTEN-2: Weight Gain Trajectory of Early Discontinuations Percent Change From Baseline in Body Weight by Treatment Completers vs. Premature Discontinuations Study Week Percent Change From Baseline in Body Weight (%) (Mean) Olanzapine ALKS 3831 175 12 16 17 13 11 8 13 7 177 8 15 14 6 9 13 7 17 St
Slide 14: ENLIGHTEN-2 Metabolic Parameters
ENLIGHTEN-2 Metabolic Parameters: Changes Were Generally Small for Both ALKS 3831 and Olanzapine Weeks
Slide 15: ENLIGHTEN-2: Early and Significant Impact on Waist Circumference
ENLIGHTEN-2: Early and Significant Impact on Waist Circumference Note: Waist circumference curve based on ANCOVA approach using MI for missing data *p<0.05 vs. olanzapine; **p<0.01 vs. olanzapine; ***p<0.001 vs. olanzapine * ** *** *** *** *** *** *** Change From Baseline in Waist Circumference (cm;
Slide 16: ENLIGHTEN-2-EXT Interim Results: Weight Remains Stable Over 52 Weeks
ENLIGHTEN-2-EXT Open-Label, Safety Extension Study Interim Results: Weight Remains Stable Over 52 Weeks
Slide 17: ENLIGHTEN-2: Antipsychotic Efficacy PANSS Scores
ENLIGHTEN-2: Antipsychotic Efficacy PANSS Scores Show Continuous Improvement in Stable Patients
Slide 18: ENLIGHTEN-2: Most Common Adverse Events
ENLIGHTEN-2: Most Common Adverse Events Similar safety profile observed to date in ongoing extension safety study (ENLIGHTEN-2-EXT) ALKS 3831 (N=274) n (%) Olanzapine (N=276) n (%) Serious Adverse Events† 10 (3.6) 7 (2.5) Any Adverse Event (≥5%) 203 (74.1) 227 (82.2) Weight increased 68 (24.8) 100 (
Slide 19: ALPINE Study: Aripiprazole Lauroxil and Paliperidone Palmitate Initiation Effectiveness
© 2019 Alkermes. All rights reserved. ALPINE Study Aripiprazole Lauroxil and Paliperidone Palmitate: Initiation Effectiveness
Slide 20: ALPINE: Study Design
ALPINE: Study Design ARISTADA® INVEGA SUSTENNA®
Slide 21: ALPINE: Demographics and Baseline Characteristics
ALPINE: Demographics and Baseline Characteristics ARISTADA® (n=99) INVEGA SUSTENNA® (n=101) Age, mean (SD), y 43.5 (9.7) 43.4 (10.8) Male, n (%) 73.0 (73.7) 76.0 (75.2) Weight, mean (SD), kg 84.8 (19.8) 85.0 (18.8) BMI, mean (SD), kg/m2 28.2 (5.5) 27.9 (5.1) PANSS total score, mean (SD)† 94.1 (9.0)
Slide 22: ALPINE: Change From Baseline in PANSS Total Score
ALPINE: Change From Baseline in PANSS Total Score ***p<0.001 (change from baseline within group) Primary endpoint was the change from baseline in PANSS total scores at Week 4 within each treatment group -19.8*** -22.5*** -21.7*** -23.3*** -17.4*** -20.1*** ® ®
Slide 23: ALPINE: Study Retention
ALPINE: Study Retention ARISTADA® (n=99) INVEGA SUSTENNA® (n=101) Subjects Who Completed the Treatment Period, n (%) 56 (56.6) 43 (42.6) Subjects Who Discontinued Study, n (%) 43 (43.4) 58 (57.4) Most Common Reasons for Discontinuation, n (%) Withdrawal by Subject 20 (20.2) 31 (30.7) Adverse Event 1
Slide 24: ALPINE: Most Common Adverse Events
ALPINE: Most Common Adverse Events Most Common Adverse Events, n (%) ARISTADA® (n=99) INVEGA SUSTENNA® (n=101) AEs ³ 5% Injection site pain 17 (17.2) 25 (24.8) Weight increased 9 (9.1) 17 (16.8) Akathisia 9 (9.1) 11 (10.9) Headache 8 (8.1) 8 (7.9) Somnolence 4 (4.0) 7 (6.9) Dystonia 3 (3.0) 6 (5.9)
Slide 25: ALKS 3831
ALKS 3831 Investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of schizophrenia Designed to provide antipsychotic efficacy of olanzapine with a favorable weight profile Reported positive topline results from ENLIGHTEN-2, a six-month phase 3 study assessing
Slide 26: Diroximel Fumarate (DRF, formerly BIIB098)
Diroximel Fumarate (DRF, formerly BIIB098) Investigational product for the treatment of relapsing forms of multiple sclerosis (MS) License and collaboration agreement with Biogen announced in Q4’17 NDA filed; PDUFA date in Q4’19 Biogen intends to commercialize under the brand name VUMERITY™, which h
Slide 27: ALKS 4230
ALKS 4230 Novel immuno-oncology candidate Designed to selectively activate intermediate-affinity IL-2 receptors to enhance tumor-killing immune cells Monotherapy dose-escalation stage of phase 1 study ongoing Initiated evaluation of safety and anti-tumor activity of ALKS 4230 in combination with pem
Slide 28: Significant News Flow Expected in 2019
ARISTADA® Report topline results for ALPINE phase 3b study (Q2) ALKS 3831 Present ENLIGHTEN-2 data at medical meeting (Q2) Submit NDA for schizophrenia (mid-year) VIVITROL® Present and publish data on detox and induction strategies Diroximel fumarate Report topline data for EVOLVE-MS-2 head-to-head
Slide 29: www.alkermes.com
www.alkermes.com © 2019 Alkermes. All rights reserved.