Alkermes Plc · NASDAQ:ALKS
Alkermes — Q2 2018 Earnings Presentation
18 slides from Alkermes's earnings presentation, Jul 26, 2018
Slide 1: Second Quarter 2018 Financial Results & Update
Alkermes Patient inspired Second Quarter 2018 Financial Results & Update July 26, 2018 2018 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: the fu
Slide 3: Q2 Earnings Call Agenda
Q2 Earnings Call Agenda Q2 Financial Results Jim Frates Chief Financial Officer Commercial update Jim Robinson President & Chief Operating Officer R&D Update Richard Pops Chief Executive Officer Alkermes 2018 Alkermes. All rights reserved.
Slide 4: Second Quarter Summary and Recent Events
Second Quarter Summary and Recent Events Financial Results Q2 2018 total revenues increased 39% year-over-year to $304.6M VIVITROL® net sales increased 15% year-over-year to $76.2M ARISTADA® net sales increased 48% year-over-year to $33.6M Recognized license revenue from Biogen collaboration for BII
Slide 5: Q2 2018 Revenue Summary
Q2 2018 Revenue Summary Total Revenues ($M) $218.8 Q22017 $304.6 Q22018 In millions, except % Q2’18 Q2’17 ∆ Q2’18 VS. Q2’17 VIVITROL® $76.2 $66.1 15% ARISTADA® $33.6 $22.7 48% Manufacturing & Royalty Revenues $128.2 $129.3 -1% License & R&D Revenues $66.6 $0.8 Total Revenues $304.6 $218.8 39% Alkerm
Slide 6: Revenues From Proprietary Commercial Medicines
Revenues From Proprietary Commercial Medicines Proprietary Commercial Product Revenues ($M) $120 $100 $80 $60 $40 $20 $0 Q1’16 Q2’16 Q3’16 Q4’16 Q1’17 Q2’17 Q3’17 Q4’17 Q1’18 Q2’18 ARISTADA aripiprazole lauroxil extended-release injectable suspension 441mg 662 mg 882 mg 1064 mg VIVITROL (naltrexone
Slide 7: VIVITROL Performance
VIVITROL ®Performance VIVITROL Quarterly Net Sales ($M) $80 $70 $60 $50 $40 $30 $20 $10 $0 Q1’16 Q2’16 Q3’16 Q4’16 Q1’17 Q2’17 Q3’17 Q4’17 Q1’18 Q2’18 Q2 year-over-year net sales growth of 15%, driven by unit growth Q2’18 results reflect estimated 49% Medicaid units and 51% non-Medicaid units Net sa
Slide 8: ARISTADA Performance
ARISTADA® Performance ARISTADA Quarterly Net Sales ($M) $35 $30 $25 $20 $15 $10 $5 $0 Q1’16 Q2’16 Q3’16 Q4’16 Q1’17 Q2’17 Q3’17 Q4’17 Q1’18 Q2’18 Q2 year-over-year net sales growth of 48% Sequential growth of 15% compared to Q1’18 Approximately 43% gross-to-net deductions 2018 net sales expectations
Slide 9: Alkermes: 2018 Financial Expectations
Alkermes: 2018 Financial Expectations † (in millions, except per share amounts) Financial Expectations for Year Ending Dec. 31, 2018 Revenues $975 – 1,025 COGS $180-180 R&D Expense $415 – 445 SG&A Expense $515 – 545 Amortization of Intangible Assets ~$65 Net Interest Expense ~$10 Income Tax Expense
Slide 10: VIVITROL: Opportunities to Increase Utilization and Drive Growth
VIVITROL®: Opportunities to Increase Utilization and Drive Growth State and federal dollars are being allocated; Funding slowly flowing into fragmented treatment system ~$1B of funding provided by 21st Century Cures Act has been distributed to states via block grants Small percentage has flowed from
Slide 11: ARISTADA: Focused on Patient-Centered Treatment Options
ARISTADA®: Focused on Patient-Centered Treatment Options ARISTADA INITIO™ approved by FDA on June 29 ARISTADA INITIO regimen* provides an opportunity to initiate patients onto any dose of ARISTADA on day 1; Replaces need for concomitant 21 days of oral aripiprazole ARISTADA is now the first and only
Slide 12: ALKS 5461 Program
ALKS 5461 Program Investigational product for adjunctive treatment of major depressive disorder (MDD) in patients with inadequate response to standard antidepressant therapy Opioid system modulator represents a new mechanism of action for the treatment of MDD Status Regulatory review underway, PDUFA
Slide 13: ALKS 3831 Program
ALKS 3831 Program 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 Status Positive results from
Slide 14: BIIB098 (Formerly ALKS 8700) Program
BIIB098 (Formerly ALKS 8700) Program Investigational product for the treatment of relapsing forms of multiple sclerosis (MS) License and collaboration agreement with Biogen announced in Q4 2017 Status Long-term safety study ongoing Pharmacokinetic bridging studies and clinical requirements for regis
Slide 15: ALKS 4230 Program
ALKS 4230 Program Novel immuno-oncology candidate Designed to selectively activate intermediate-affinity IL-2 receptors to enhance tumor-killing immune cells Status Monotherapy dose-escalation stage of phase 1 study ongoing Plans to initiate evaluation of safety and anti-tumor activity of ALKS 4230
Slide 16: ALKS 4230 Phase 1 Study Design
ALKS 4230 Phase 1 Study Design Monotherapy Dose Escalation Determine maximum tolerated dose and recommend phase 2 dose Monotherapy Dose Expansion Renal Cell Carcinoma Cohort Melanoma Cohort Combination Therapy: ALKS 4230 + Pembrolizumab PD-1 Approved Tumor Types Treatment Naïve Patients PD-1 Approve
Slide 17: Significant News Flow Expected in 2018
Significant News Flow Expected in 2018 ARISTADA®: New initiation product approved ARISTADA INITIO™ approved June 29 ALKS 5461: Regulatory review underway NDA accepted for filing Advisory Committee meeting tentatively scheduled for Nov. 1 ALKS 3831: Data from second pivotal study ENLIGHTEN-2 weight s
Slide 18: www.alkermes.com
www.alkermes.com 2018 Alkermes. All rights reserved.