N a s d a q : I N S Y
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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 forward-looking statements or historical information contained herein.
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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
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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 2017
- Advancing deep pipeline with multiple opportunities to deliver long-term value in the business
- State of the art manufacturing capabilities for pharmaceutical cannabinoids
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Strategic Roadmap
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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
Strengthen the Foundation
Stabilize and Strengthen
Portfolio
Advance Our Pipeline
Resolve Government
Investigations
Strategic Imperatives
Strategic Imperatives
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Strengthen the Foundation
• Optimize and align structure
• Strengthen commercial, medical and business partnership capabilities
• Recruit, Develop & Retain Talent
Stabilize and Strengthen
Portfolio
• Stabilize Subsys
• Launch SYNDROSTM
• Optimize Lifecycle initiatives for both products
Advance Our Pipeline
• Spray technology
• Cannabinoid platform
Resolve Government
Investigations
• Federal
• States
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
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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
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SYNDROS™ Commercial Opportunity
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Prescriber Overview1- 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 prescriptions2, with potential addressable population of ~800K in CINV and ~90k in AIDS anorexia
- Concentrated universe of ~4K prescribers write 50% of scripts
Preparing for August 2017 launch
(1) 2016 IMS TRx data (2) 2013-2016 Source Health Analytics TRx data
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
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Deep Pipeline to Drive Long-Term Growth
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Drug Candidate Disease StatePre-
ClinicalPhase 1 Phase 2 Phase 3 Submit Approval
SU
BLIN
GU
AL S
PR
AY
S
Buprenorphine Sublingual Spray
Moderate to severePain
Subsys Label Expansion
Post operative pain and pre-procedural pain
Naloxone Nasal Spray Opioid Overdose
Buprenorphine / Naloxone Sublingual Spray
Opioid Dependence
Fentanyl / MentholBreakthrough cancer pain in patients ≥18 yo
EpinephrineAnaphylaxis Reaction
CA
NN
AB
INO
IDS Syndros
(i) CINV & (ii) anorexia associated with weight loss in patients with AIDS
Syndros Label Expansion
(i) Agitation in Alzheimer’s disease (ii) Anorexia
Cannabidiol(i) Epilepsy and other indications
Dose Ranging Studies Completed
Phase 3 Completed
In Development
Approved
In Development
PK Study in refractory epilepsy
completed
In Development
In Development
In Development
Cannabinoids - Growth Strategy
11CINV: chemotherapy induced nausea & vomiting
Cannabidiol
• Pediatric Epilepsies • Addiction & other indications
SYNDROSTM
• 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
Cannabinoid Manufacturing Capabilities
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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
- Cash flow generated will fund future growth
- $218.5 million in cash, cash equivalents & investments as of March 31, 2017
- No debt
Revenue ($mm) Adjusted EBITDA ($mm)
$15.5
$99.3
$219.1
$330.3
$242.3
$0
$50
$100
$150
$200
$250
$300
$350
2012 2013 2014 2015 2016
-$17.3
$40.6
$78.8
$128.3
$39.1
-$40
-$20
$0
$20
$40
$60
$80
$100
$120
$140
2012 2013 2014 2015 2016
Insys Financial Snapshot
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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 2017
- Advancing deep pipeline with multiple opportunities to deliver long-term value in the business
- State of the art manufacturing capabilities for pharmaceutical cannabinoids
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