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1 N a s d a q : I N S Y 0
2 Safe Harbor Statement This presentation contains both historical information and forward-looking statements. Forward-looking statements are based on management's current expectations and assumptions as of the date of this presentation, and actual results may differ materially from those in these forward-looking statements as a result of various factors, including many which are beyond Insys control. Such factors include, but are not limited to risks regarding: Insys' ability to commercialize products successfully; Insys ability to successfully manage its commercial relationships and sales infrastructure; Insys ability to obtain anticipated governmental or regulatory approvals; Insys failure to comply with post-approval regulatory and governmental requirements; the actual sales potential and opportunity of identified markets; and Insys ability to realize the expectations of its pipeline and product candidate plans and timelines. For a further description of these and other risks facing Insys, please see the risk factors described in the company's filings with the United States Securities and Exchange Commission, including those factors discussed under the caption Risk Factors in those filings. All the information included herein is dated information concerning the company. The company disclaims and does not undertake any obligation to update or revise any forwardlooking statements or historical information contained herein. 1
3 Saeed Motahari, President & CEO - 20-year veteran of the life sciences industry - 8 years at Hoffmann-La Roche and Bristol-Myers Squibb Led various functional areas in the commercial organization - 10 year tenure at Abbott Laboratories & AbbVie Vice President of US Specialty Brands New Launches P&L responsibility for Specialty Franchises in multiple therapeutic areas - Purdue Pharma Chief Commercial Officer Led successful transformation of commercial organization 2
4 Insys Highlights - Differentiated products and novel proprietary drug platforms offer substantial room for growth - Addressing underserved population of patients with breakthrough cancer pain with our market leading Subsys sublingual spray - Poised to launch SYNDROS (dronabinol) oral solution in August Advancing deep pipeline with multiple opportunities to deliver long-term value in the business - State of the art manufacturing capabilities for pharmaceutical cannabinoids 3
5 Strategic Roadmap Mission Improve the quality of patient care by building a specialty pharmaceutical company focused on cannabinoids and novel drug delivery systems that address unmet patient needs Strategic Imperatives Strengthen the Foundation Stabilize and Strengthen Portfolio Advance Our Pipeline Resolve Government Investigations 4
6 Strategic Imperatives Strengthen the Foundation Stabilize and Strengthen Portfolio Advance Our Pipeline Resolve Government Investigations Optimize and align structure Stabilize Subsys Spray technology Federal Strengthen commercial, medical and business partnership capabilities Launch SYNDROS TM Optimize Lifecycle initiatives for both products Cannabinoid platform States Recruit, Develop & Retain Talent 5
7 Leveraging Two Drug Delivery Platforms Spray Technology Drug delivery via a fine mist: beneath the tongue (sublingual) in the nasal cavity (nasal) Targeting supportive care & other markets where spray product characteristics add value Ease of use / application Clinically beneficial faster speed of onset Pharmaceutical Cannabinoids SYNDROS to be positioned as a best-in-class pharmaceutical THC product Emerging cannabidiol (CBD) product pipeline 6
8 Subsys - Offering relief to patients with breakthrough cancer pain Onset of action as early as 5 minutes Seven doses from 100 to 1,600mcg Simple one-step administration process takes < 1 minute - Market leader despite challenges to TIRF product class - Market share stabilizing at ~35% Opportunities to stabilize and grow the product - Educating market about breakthrough cancer pain to improve treatment rate - Improve access - Improve adherence 7
9 SYNDROS Commercial Opportunity - SYNDROS (dronabinol) oral solution, CII, approved for: Anorexia associated with weight loss in patients with AIDS Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments - Current market at ~280k prescriptions 2, with potential addressable population of ~800K in CINV and ~90k in AIDS anorexia - Concentrated universe of ~4K prescribers write 50% of scripts Prescriber Overview 1 Preparing for August 2017 launch (1) 2016 IMS TRx data (2) Source Health Analytics TRx data 8
10 SYNDROS Commercial Strategy - Position as a best-in-class pharmaceutical THC product - Launch with existing sales force to concentrated universe of prescribers - Two-pronged approach 1. Convert existing Marinol market 2. Expand the market Highlight improved product profile - Hybrid distribution model specialty pharma and retail Peak SYNDROS sales potential >$200M 9
11 SUBLINGUAL SPRAYS CANNABINOIDS Deep Pipeline to Drive Long-Term Growth Drug Candidate Buprenorphine Sublingual Spray Subsys Label Expansion Disease State Moderate to severe Pain Post operative pain and pre-procedural pain Pre- Clinical Phase 3 Completed Phase 1 Phase 2 Phase 3 Submit Approval Dose Ranging Studies Completed Naloxone Nasal Spray Opioid Overdose In Development Buprenorphine / Naloxone Sublingual Spray Opioid Dependence In Development Fentanyl / Menthol Breakthrough cancer pain in patients 18 yo In Development Epinephrine Anaphylaxis Reaction In Development Syndros (i) CINV & (ii) anorexia associated with weight loss in patients with AIDS Approved Syndros Label Expansion (i) Agitation in Alzheimer s disease (ii) Anorexia In Development Cannabidiol (i) Epilepsy and other indications PK Study in refractory epilepsy completed 10
12 Cannabinoids - Growth Strategy SYNDROS TM Approved July 2016 for Nausea / Vomiting Associated with Cancer Chemotherapy and Anorexia / Weight Loss in Patients with AIDS Life Cycle Management Alzheimer's Agitation Anorexia in cancer patients Inhaled delivery Cannabidiol Pediatric Epilepsies Addiction & other indications CINV: chemotherapy induced nausea & vomiting 11
13 Cannabinoid Manufacturing Capabilities U.S.-based facility approved to produce pharmaceutical dronabinol (THC) and cannabidiol (CBD) with scale for commercial quantities Expanding manufacturing capacity to support future demand Constructed second facility to manufacture API for dronabinol oral solution and pharmaceutical CBD Capable of producing over 99% pure CBD synthetically in a controlled environment 12
14 Insys Financial Snapshot - Cash flow generated will fund future growth - $218.5 million in cash, cash equivalents & investments as of March 31, No debt Revenue ($mm) Adjusted EBITDA ($mm) $350 $330.3 $140 $128.3 $300 $120 $250 $200 $219.1 $242.3 $100 $80 $78.8 $150 $100 $99.3 $60 $40 $40.6 $39.1 $50 $15.5 $20 $ $0 -$20 -$ $
15 Insys Highlights - Differentiated products and novel proprietary drug platforms offer substantial room for growth - Addressing underserved population of patients with breakthrough cancer pain with our market leading Subsys sublingual spray - Poised to launch SYNDROS (dronabinol) oral solution in August Advancing deep pipeline with multiple opportunities to deliver long-term value in the business - State of the art manufacturing capabilities for pharmaceutical cannabinoids 14
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