Slide 1: 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: future
Slide 2: Q1 Earnings Call Agenda
Q1 Earnings Call Agenda 3 Introduction Richard Pops Chief Executive Officer Commercial Update Jim Robinson President & Chief Operating Officer Q1 Financial Results and 2018 Expectations Jim Frates Chief Financial Officer R&D Update Richard Pops Chief Executive Officer
Slide 3: First Quarter Summary and Recent Events
Q1 total revenues increased 17% year-over-year to $225.2M VIVITROL® net sales increased 7% year-over-year to $62.7M ARISTADA® net sales increased 62% year-over-year to $29.2M R&D revenue from Biogen BIIB098 (formerly ALKS 8700) collaboration of $17.5M GAAP net loss of $62.5M, compared to a GAAP net
Slide 4: ALKS 5461
Investigational product for adjunctive treatment of major depressive disorder (MDD) in patients with inadequate response to standard antidepressant therapy Opioid system modulator with new mechanism of action Program Status NDA accepted for filing by FDA, PDUFA target action date Jan. 31, 2019 Publi
Slide 5: VIVITROL: Opportunities to Increase Utilization and Drive Growth
Policymakers activating to address opioid epidemic at national level Focus on implementation of Comprehensive Addiction and Recovery Act and introduction of new legislation in Congress to address opioid epidemic State and federal dollars are being allocated; Funding slowly flowing into fragmented tr
Slide 6: ARISTADA: Focused on Patient-Centered Treatment Options
NDA under review by FDA for Aripiprazole Lauroxil NanoCrystal® Dispersion (ALNCD) for initiation onto ARISTADA PDUFA date of June 30, 2018 New initiation regimen designed to replace need for concomitant three weeks of oral aripiprazole* Provides an extended-release aripiprazole lauroxil formulation
Slide 7: Q1 2018 Revenue Summary
Q1 2018 Revenue Summary In millions, except % Q1’18 Q1’17 Q1’18 VS. Q1’17 VIVITROL® $62.7 $58.5 7% ARISTADA® $29.2 $18.0 62% Manufacturing & Royalty Revenues $114.6 $114.7 0% R&D Revenue $18.7 $0.6 - Total Revenues $225.2 $191.8 17% Total Revenues ($M) 8 $191.8 $225.2 $0 $25 $50 $75 $100 $125 $150 $
Slide 8: Revenues From Proprietary Commercial Medicines
Revenues From Proprietary Commercial Medicines Proprietary Commercial Product Revenues ($M) 9 $0 $20 $40 $60 $80 $100 $120 Q1'16 Q2'16 Q3'16 Q4'16 Q1'17 Q2'17 Q3'17 Q4'17 Q1'18
Slide 9: VIVITROL First Quarter Performance
VIVITROL® First Quarter Performance Q1 year-over-year net sales growth of 7%, driven by underlying unit growth of 21% Q1’18 results reflect estimated 52% Medicaid units and 48% non-Medicaid units Gross-to-net deductions increased to 50% in Q1’18, from 44% in Q1’17 2018 net sales expectations of $300
Slide 10: ARISTADA: Growing in Volume and Gaining Market Share
Sequential TRx growth of 6% compared to Q4’17 Approximately 43% gross-to-net deductions ARISTADA market share increased to 26% among new aripiprazole long-acting atypical prescriptions (months of therapy) in Q1’18, compared to 19.5% in Q1’171 2018 net sales expectations of $140M - $160M ARISTADA® Gr
Slide 11: Alkermes: 2018 Updated Financial Expectations
(in millions, except per share amounts) Financial Expectations for Year Ending Dec. 31, 2018† Revenues $975 – 1,025 COGS $180 – 190 R&D Expense $415 – 445 SG&A Expense $515 – 545 Amortization of Intangible Assets ~$65 Net Interest Expense ~$10 Income Tax Expense $0 – 10 GAAP Net Loss $(210) – (240)
Slide 12: 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 and a differentiated safety profile with favorable weight and metabolic properties Positive results from ENLIGHTEN-1 pi
Slide 13: BIIB098 (Formerly ALKS 8700)
BIIB098 (Formerly ALKS 8700) Investigational product for the treatment of relapsing forms of multiple sclerosis (MS) License and collaboration agreement with Biogen announced in Q4 2017 Long-term safety study ongoing MRI and relapse results in patients with relapsing and remitting MS presented at AA
Slide 14: ALKS 4230
ALKS 4230 Novel immuno-oncology candidate Designed to selectively activate intermediate-affinity IL-2 receptors to enhance tumor-killing immune cells Dose-escalation stage of phase 1 study ongoing Accelerating and expanding planned clinical development program Complete dose-escalation stage Advance
Slide 15: Significant Newsflow Expected in 2018
ARISTADA®: Next potential FDA approval Aripiprazole Lauroxil NanoCrystal® Dispersion (ALNCD) PDUFA June 30 ALKS 5461: Regulatory review underway NDA accepted for filing Advisory Committee Meeting (Expected Q4) ALKS 3831: Data from second pivotal study ENLIGHTEN-2 weight study enrollment completion M
Slide 16: Significant Newsflow Expected in 2018
Significant Newsflow Expected in 2018 ARISTADA®: Next potential FDA approval Q Aripiprazole Lauroxil NanoCrystal® Dispersion (ALyjcp) PDUFA June 30 ALKS 5461: Regulatory review underway v NDAaccepted for filing Q Advisory Committee Meeting (Expected Q4) ALKS 3831: Data from second pivotal study vy E
Slide 17: www.alkermes.com
” www.alkermes.com