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Investor PresentationCantor Global Healthcare Conference
October 2, 2018
(Nasdaq: INSY)
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 finalize documents with the DOJ and OIG or to comply with post-approval regulatory
and governmental requirements; the actual sales potential and opportunity of identified markets; INSYS’ ability to manage and
resolve, under acceptable terms and conditions, its ongoing legal proceedings and litigation, including various governmental
investigations; 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.
Key Facts
NASDAQ INSY
Founded 2002
Headquarters Chandler, AZ
TTM Revenue* $110M
Cash on Hand* $124M
R&D Investment ~$250M
since ’14
Two FDA-approved products
available in U.S.
– SUBSYS® (fentanyl sublingual spray)
launched in 2012
– SYNDROS® (dronabinol) oral solution
launched in 2017
Investment Thesis
3
▪ Transformation from opioid focus to Cannabinoids/Sprays
– Driven by new management, governance, employee base, vision and culture
▪ Current commercial products provide platform to support transformation
▪ Deep, well-differentiated pipeline across cannabinoids and spray platforms
– Potential for at least five NDAs through 2021
▪ State of the art manufacturing facility approved by DEA and FDA
– U.S. based synthetic cannabinoid manufacturing facility that can produce at scale
– Long-term competitive advantage: proprietary synthetic CBD process (99%+ pure)
Emerging leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology
*as of 6/30/18
Two Innovative Drug Development Platforms
4
1) Pharmaceutical Cannabinoids
SYNDROS® Pharmaceutical THC Oral Solution Product
▪ Oral Solution Delivery (launched Aug ’17)
▪ Inhalation Delivery (in development)
Cannabidiol (CBD) Product Pipeline
▪ Oral Solution Delivery (in development)
Oral Solution
Sublingual
Disease States Under Investigation
• Childhood Absence Epilepsy
• Infantile Spasms
• Prader-Willi-Syndrome
• Anorexia in Cancer
2) Spray Technology
Drug delivery via fine mist:
▪ Under the tongue (sublingual) – SUBSYS®
▪ In the nasal cavity (intranasal)
Targeting patient populations and disease states where spray
product characteristics add value
▪ Clinically beneficial faster speed of onset
▪ Ease of use / application
Disease States Under Investigation
• Anaphylaxis
• Opioid Overdose
• Opioid Dependence
• Pain
Inhalation
Nasal
Two FDA-Approved Commercial Products
51 Exit share as of August 2018 (source: IQVIA)
▪ Indicated for:
– Management of breakthrough cancer pain in opioid-tolerant
adult cancer patients
▪ Branded market leader in TIRF class
– (TIRF = Transmucosal Immediate Release Fentanyl)
• Script share1 ~28%
• Unit share1 ~33%
▪ Meaningfully differentiated:
– Better bioavailability than Actiq
– Rapid onset of action
– Simple one-step administration process
– Widest dose range
▪ Proprietary sublingual spray formulation
▪ Recently started to expand commercial presence internationally
– Lunatus in Middle East
– Other regions under consideration
▪ Indicated for:
– Anorexia associated with weight loss in patients with AIDS
– Chemotherapy-induced nausea and vomiting (CINV) in patients
with cancer whose response to conventional antiemetics is
inadequate
▪ Potential addressable population:
– ~800K in CINV
– ~90K in AIDS anorexia
▪ Conservative launch August 2017 with slow uptake comparable with
other CII products
▪ Life-cycle management:
– Novel inhalation device
– Proof-of-concept study Q3 2018
– Exploring label expansion (anorexia in cancer)
✓
✓
✓
Strategic Roadmap & Key Priorities
6
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.
Our Vision…
Supported by: Strong Culture of Compliance
▪ Building new culture of
compliance and ethics
▪ Reached agreement in
principle with DOJ
Resolve Government Investigations & Rebuild Reputation
1
Our Priorities…
✓ ▪ Recruiting & retaining
people of character &
experience
▪ Augmenting capabilities
& optimizing processes
Strengthen the Foundation & Enhance Execution
2
Shifting from opioids to cannabinoids
Three major programs underway in CBD
Exploring collaborative research partnerships
Advance and Develop Diverse Pipeline to Drive Future Growth
3
▪ Sales Force talent
upgrade & realignment
▪ Expanding managed
care contracts & patient
services
▪ Exploring international
expansion
Stabilize and Grow Marketed Portfolio
4
✓
✓
✓
✓
Legal Landscape
7
Resolve Government Investigations & Rebuild Reputation
1
1) Department of Justice
▪ Settlement Agreement in Principle
as of August 8, 2018
▪ $150 million payable over five years
▪ Management estimate of $0 to $75
million in potential contingency-
based payments
▪ When documentation finalized,
resolves both criminal and civil
charges
2) Individual State Suits
▪ Settled with 4 states
▪ Received subpoenas from 15+ states
▪ Pending suits from 8 states
Strengthen the Foundation & Enhance Execution
2
New Leadership Across the Organization
8
▪ ~40% of current employees have less tenure than CEO
▪ ~50% of current sales reps joined INSYS in 2017 and 2018
▪ More than two-thirds of company’s Board is new since April 2017
Scott WarlickGeneral Manager & Director ofManufacturing
▪ 15+ years in site management,
operations, maintenance,
process
engineering/optimization
• Mylan
• Mallinckrodt
Manufacturing
Brian JenningsVP, Sales
▪ 25+ years of industry
experience
• Purdue Pharma
• Publicis Healthcare Group
• Sanofi
• Roche U.S. (Genentech)
• Unimed
Executive Leadership
Dr. Dean Mariano, D.O.Senior Director of Clinical Development &Medical Affairs
▪ 15+ years of pain management
practice experience
▪ President of CT Pain Society
▪ Chairman of the CT State
Medical Society’s Task Force on
Opioids
Clinical Development
Ariyapadi KrishnarajVP, Commercial
▪ 30+ years in industry and
consulting experience
• Iroko Pharmaceuticals
• Novartis
• GlaxoSmithKline
• Consultant: Endo & Takeda
Executive Leadership
Andy LongChief Financial Officer
▪ 30+ years in financial
leadership positions across bio
pharma, life sciences, and
industrial sectors
• Patheon
• Thermo Fisher
• Abbott Laboratories
Executive Leadership
Saeed MotahariPresident & CEO
▪ 20-year veteran in the life sciences industry
• Hoffmann-La Roche
• Bristol-Myers Squibb
• Abbott Laboratories & AbbVie
• Purdue Pharma
Executive Leadership
Carol Summersgill VP Human Resources
▪ 20+ years of HR leadership
• Libbey Inc.
• Philosophy, Inc.
• Therma-Tru Doors, Inc.
• Whirlpool Corp.
Executive Leadership
Dr. Ahmed Elkashef, M.D.Vice Presidentof Clinical Development
▪ 30+ years of clinical practice and research experience
• National Institute on Drug Abuse (N.I.D.A.)
• U.A.E.’s National Rehabilitation Center
• N.I.H.’s National Institute on Mental Health (N.I.M.H.)
Clinical Development
Unique Manufacturing Capabilities
9
Facilities (DEA & FDA-approved):
▪ Invested ~$14M since 2016 in manufacturing capabilities
▪ Oakmont plant – 83,000 sq. ft. for cannabinoid API* and finished
drug product
▪ Paloma plant – 8,000 sq. ft. for cannabinoid API* only
Process Technology:
▪ Developed and IP-owned by INSYS
▪ Improving capacity, yield and purity of CBD synthesis
▪ Easy to expand for additional capacity
People:
▪ Strong leadership team with extensive experience in API production
leading ~50 fully trained employees
Systems:
▪ cGMP compliance successfully passed FDA inspection multiple times
▪ Meeting all requirements from DEA, EPA, OSHA and other
government regulations
* API = Active Pharmaceutical Ingredient
Strengthen the Foundation & Enhance Execution
2
10
Deep Pipeline to Drive Long-Term Growth
• *Pursuing 505(b)2 bioequivalence approach for potential approval• **FDA requires additional juvenile nonclinical toxicity studies as part of the pediatric plan.
Drug Candidate Disease State Non-Clinical Phase 1 Phase 2 Phase 3 Submit Approval
CA
NN
AB
INO
IDS
Cannabidiol (CBD)Oral Solution
(i) Childhood Absence Epilepsy
(ii) Infantile Spasms
(iii) Prader-Willi Syndrome
DronabinolInhalation
Anorexia in Cancer
SPR
AY
S
Naloxone* Nasal Spray
Opioid Overdose
Epinephrine* Nasal Spray
Anaphylaxis
Buprenorphine/NaloxoneSublingual Spray
Opioid Dependence
BuprenorphineSublingual Spray
Moderate-to-Severe Acute Pain
Ph 2 Enrolling (n=30)
Ph 3 Initiated (n=190)
Ph 2 Enrolling (n=66)
PK Completed
In Dev
In Dev
NDA Filed
Fast Track Designation Granted Dec 2017
PK Study Completed Sept 2018
PK Completed
CRL Rec’d July 2018
Fast Track Designation Granted Aug 2018
Orphan Drug DesignationGranted Aug 2015
NDA Filing 1Q2019**
Pipeline Priority and Valuation
11
1) CBD
2) Epinephrine
3) Dronabinol Inhalation
4) Buprenorphine/Naloxone
5) Naloxone
Bup
Inve
stm
ent
2
High
Low
Early Late
Pipeline Project Assessment 1
Project Status 3
Market Potential Ranking
Medium to high market opportunity
Low to medium market opportunity
1 Pipeline assets have been prioritized after an assessment of investment, project progress and market attractiveness (represented by bubble size). 2 Investment refers to projected remainder development costs.3 Project status as of 2018.
Epinephrine
Dronabinol Inhalation
CBD
Bup/ Naloxone Naloxone
12
Over 16 years Cannabinoid Experience
▪ Over 16 years of experience working with Cannabinoids
▪ 2 Cannabinoid (THC capsule and oral solution) products approved by FDA
▪ CBD oral solution currently in development
▪ Three CBD clinical trials currently underway
▪ Childhood Absence Epilepsy (CAE)
▪ Infantile Spasms (IS)
▪ Prader-Willi Syndrome
▪ Completed 5 studies in Cannabidiol (CBD) in the last five years
▪ Over 150 subjects dosed with INSYS oral solution CBD
▪ 25 patients in the Expanded Access Program have been on CBD for over 3 years
▪ Generally well-tolerated adverse event profile, commonly reported AEs included diarrhea and somnolence
Completed CBD Trial INS011-14-029
13
• Title: A Phase 1/2 study to assess the pharmacokinetics and safety of multiple doses of pharmaceutical Cannabidiol Oral Solution in pediatric subjects with treatment-resistant seizure disorders
• Number of patients: 61
• Number of sites: 10
• Objectives:
• To characterize the PK of Cannabidiol Oral Solution in pediatric subjects with treatment-resistant seizures
• To assess the safety of Cannabidiol Oral Solution in pediatric subjects with treatment-resistant seizures
• To assess any improvement in qualitative assessments of subject status over the duration of the study
Data Presented at American Epilepsy Society (AES) Meeting 2017 Title: Pharmacokinetics and Tolerability of Multiple Doses of Pharmaceutical-Grade Synthetic Cannabidiol Oral
Solution in Pediatric Patients With Treatment-Resistant Seizure Disorders
INS011-14-029: High-Level Result Summary
14
• Three doses of 10mg/kg/day, 20mg/kg/day and 40mg/kg/day were studied in patients 1-17yrs old with treatment resistant seizure disorders (61 subjects enrolled)
• Steady state level of CBD observed by Day 4 after repeated dosing
• Dose proportionality established between doses
• Generally well tolerated adverse event profile, commonly reported AEs included diarrhea and somnolence
American Epilepsy Society (AES) Meeting Q4 2018 Abstract presentation : Long-Term Safety of Pharmaceutical Cannabidiol Oral Solution as Adjunctive Treatment for
Pediatric Patients With Treatment-Resistant Epilepsy
52 of 61 patients in the 029 PK enrolled in the 030 long-term safety study Results of long-term study demonstrate that all Cannabidiol Oral Solution doses were
generally well-tolerated even at doses as high as 40 mg/kg/day
Of the 52 patients that rolled into the 030 Long Term Safety Study, 45 completed the 48-week study and 25 currently remain on CBD in the Expanded Access Program
Phase 3
Actively Enrolling
% of patients considered complete responders, defined as complete resolution of spasms and hypsarrhythmia confirmed by 24-hr video-EEG from Day 14 to Day 15.
Phase 2
Actively Enrolling
At Week 4 vs. baseline:• % change in absence sz counts • % change in time to absence sz during
hyperventilation testing • % patients sz free based on sz diary• Investigator CGI-I* at Week 4
Phase 2
Actively Enrolling
Change in total score of Hyperphagia Questionnaire for Clinical Trials (HQ-CT) through study completion or early withdrawal.
▪ Orphan drug status granted July 2015
▪ Onset age: 1 – 24 months
▪ EEG shows hypsarrhythmia
▪ Prevalence: 98,062 children
▪ Usually “staring spells” lasting 10 – 20 seconds
▪ 2% – 8% of people with epilepsy
▪ Two-thirds with CAE respond to treatment
▪ Prevalence: 9,400 – 37,600 children
Prader-Willi Syndrome
▪ Fast Track Review Granted December 2017
▪ Mutation in 15q11–13 (paternal)
▪ 25% mortality by age 18
▪ Insatiable appetite
▪ Prevalence: 1 per 10,000 – 30,000
Infantile Spasms Child Absence Epilepsy
* CGI-I = Clinical Global Impression–Improvement Scale
Source: (1) Cowan and Hudson 1991 (2) Foundation for PW Research (3) Trevathan, Murphy, Yeargin-Allsopp 1999 (4) Jallon and Latour 2005 (5) RareDiseases.org
Ongoing CBD Clinical Trials
15
• Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution as Adjunctive Therapy with Vigabatrin as Initial Therapy in Patients with Infantile Spasms
• Status: Actively enrolling
• Sites: approximately 40 sites in US and ex-US
• Objectives:
• Primary:
• To evaluate the efficacy of Cannabidiol Oral Solution as adjunctive therapy with vigabatrin as initial therapy in treating patients with Infantile Spasms
• Secondary:
• To evaluate the continued efficacy of Cannabidiol Oral Solution after the 14-day treatment with vigabatrin or vigabatrin plus Cannabidiol Oral Solution is complete
• To evaluate the safety and tolerability of Cannabidiol Oral Solution as adjunctive therapy with vigabatrin as initial therapy in treating patients with Infantile Spasms
16
CBD Clinical Trials - Phase 3 Infantile Spasms
Data Presented at American Epilepsy Society Meeting 2017 Title: A Phase-2 Study of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution for
Treatment of Refractory Infantile Spasms
Results from Phase 2 study, CBD monotherapy for double refractory Infantile Spasms(1 out 7 enrolled had a complete response)
Shifted the development program to investigate CBD as adjunctive therapy for initial therapy in Infantile Spasms
Collaborative CBD Trials Under Consideration
17
▪ Autism
▪ Early Psychosis
▪ Anorexia Nervosa
Collaborating with University of California San Diego School of Medicine’s Center for Medicinal Cannabis Research
▪ Childhood Schizophrenia/ Early Psychosis
Orphan Drug Designation
Possible collaboration with NIMH
▪ Addiction Possible collaboration with NIDA and NIAAA
▪ Post-Traumatic Stress Disorder
Possible collaboration with DOD and VA
✓
✓
Epinephrine Nasal Spray: Fast Tracked
18
▪ Received Fast Track Designation from FDA in August 2018
– Prior pharmacokinetic study of 60 people with seasonal allergies demonstrated rapid drug
absorption
– Showed bioavailability of the company’s novel, proprietary formulation of epinephrine
delivered intranasally was similar to that of intramuscular injection with EpiPen® (0.3 mg)
▪ Anaphylaxis is acute, life-threatening systemic allergic reaction
– U.S. incidence: 200,000+ cases per year1
– Worldwide prevalence: lifetime risk globally per person of 0.5 – 2%2
▪ ~$1.7 billion U.S. market in 2017 with ~25% CAGR (2012–17)3
▪ Epinephrine is most important medicine to give during life-threatening anaphylaxis4
▪ Current epinephrine products are all invasive
▪ Supply shortage of auto-injectors / injectables in U.S.
▪ Meaningful clinical opportunity for potential nasal spray
1 Mayo Clinic, 2 World Allergy Organization, 3 IQVIA, 4 Symphony Health Solutions
American Academy of Allergy, Asthma & Immunology (AAAI) Annual Meeting 2019Abstract submitted to present PK Study Data (pending acceptance)
▪ Human Factors Study completed
▪ Ongoing nonclinical studies recently requested by
FDA prior to NDA submission
▪ NDA submission target date: Q1 2019*
– Strategy for filing
1. Fast Absorption
2. Higher Exposure (AUC) than all Narcan/Naloxone preparations
3. Longer duration (up to 2 hours) formulation to combat the rising epidemic of synthetic opioids overdose
Naloxone: NDA Preparation
$251
$310 $372
$440
$517
$599
$664$719
$773$827
$885
$0
$100
$200
$300
$400
$500
$600
$700
$800
$900
$1,000
2016(A)
2017(A)
2018(E)
2019(E)
2020(E)
2021(E)
2022(E)
2023(E)
2024(E)
2025(E)
2026(E)
Nal
oxo
ne
Glo
bal
Mar
ket
Val
ue
(U
S M
$)
Global Naloxone Market Value Estimates (USD $M)
Source: Coherent Market Insights (Global Industry Insights: Naloxone Market)
19
American Society of Addiction Medicine (ASAM) 2019College on Problems of Drug Dependence (CPDD) 2019Abstracts in development to present Naloxone PK study data
Note: US represents ~75% in 2018 with increasing shares from EU (upto ~33% projected) in forward years
*FDA requires additional pediatric nonclinical toxicity studies as part of the pediatric plan.
North America $169 $224 $279 $319 $350 $377 $403 $430 $459 $491 $525
Drug Candidate
Targeted Indication
Delivery Method
Recent Milestones
Upcoming Milestone
NaloxoneOpioid
OverdoseNasal Spray
▪ End of Phase 2 FDA meeting (Feb 2018)
▪ Completed PK studies
▪ Nonclinical studies to be completed in 2018
NDA filingQ1 2019*
Epinephrine Anaphylaxis Nasal Spray▪ Proof-of-concept study enrollment completed
▪ End of Phase 2 FDA meeting (Aug 2018)
NDA filing2H 2019
Cannabidiol (CBD)
Childhood AbsenceEpilepsy
Oral Solution
▪ Enrolling Phase 2 studyData read Q4 2018
Infantile Spasms ▪ Enrolling Phase 3 studyData read Q4 2019
Prader-Willi Syndrome
▪ Initiated and recruiting proof-of-concept study
▪ Received ‘Fast Track’ designation (Dec 2017)
Data read Q2 2019
Dronabinol (THC)Anorexia in
CancerInhalation
Device▪ Proof-of-concept PK study (healthy subjects) completed
(Sept 2018)
AdvisoryBoard
1H 2019
Key R&D Projects and Milestones
20* FDA requires additional juvenile nonclinical toxicity studies as part of the pediatric plan.
21
Potential for 6 NDA’s over the next 3 Years
2019 2020 2021
Projected NDA Timelines
NaloxoneOpioid Overdose
EpinephrineAnaphylaxis
CBDInfantile Spasms
DronabinolAnorexia in Cancer
CBDChildhood Absence Epilepsy
CBDPrader-Willi Syndrome
Commercial Strategies Overview
22
Executing SUBSYS® Stabilization Initiatives
◼ Positive signs from managed care wins
◼ Increasing awareness of breakthrough cancer pain
associated with bone metastasis
◼ Exploring collaborative licensing opportunities
internationally
SYNDROS® Brand Awareness Programs Continued
◼ Q2 2018 net revenue of $1 million (56% sequential
improvement)
◼ Continuing HCP education programs
◼ Pursuing additional managed care wins
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
Mo
nth
ly P
resc
rip
tio
ns
SUBSYS® and TIRF Market TRxs as of August 2018
All other TIRF SUBSYS®
Sep-17 Oct-17 Nov-17 Dec-17 Jan-18 Feb-18 Mar-18 Apr-18 May-18 Jun-18 Jul-18 Aug-18
SUBSYS 946 975 888 836 716 676 666 632 616 636 582 592
TIRF Total 3,162 3,181 2,959 2,864 2,686 2,374 2,512 2,173 2,220 2,113 2,105 2,113
Market Share
30% 31% 30% 29% 27% 28% 27% 29% 28% 30% 28% 28%
Stabilize and Grow Marketed Portfolio
4
Source: IQVIA
Financial Snapshot
23
Revenue (millions) Adjusted EBITDA (millions)▪ $124M in cash at end of Q2
2018
▪ No debt
▪ Gross margins ~90%
▪ Optimizing operating expenses while fully funding R&D
– Rightsized commercial organization
– Leveraging supplier base
– Tight headcount controls
$0
$5
$10
$15
$20
$25
$30
$35
$40
$45
Q2'17 Q3'17 Q4'17 Q1'18 Q2'18
-$27
-$22
-$17
-$12
-$7
-$2
$3
Q2'17 Q3'17 Q4'17 Q1'18 Q2'18
Operating Expenses* (millions)
$0
$50
$100
$150
$200
$250
Q2'17 Q3'17 Q4'17 Q1'18 Q2'18
Total Cash, Short-Term, Long-Term Investments (millions)
$0
$10
$20
$30
$40
$50
Q2'17 Q3'17 Q4'17 Q1'18 Q2'18
Sales & Marketing R&D G&A Legal* Excludes settlements
Investment Thesis
24
▪ Transformation from opioid focus to Cannabinoids/Sprays
– Driven by new management, governance, employee base, vision and culture
▪ Current commercial products provide platform to support transformation
▪ Deep, well-differentiated pipeline across cannabinoids and spray platforms
– Potential for at least five NDAs through 2021
▪ State of the art manufacturing facility approved by DEA and FDA
– U.S. based synthetic cannabinoid manufacturing facility that can produce at scale
– Long-term competitive advantage: proprietary synthetic CBD process (99%+ pure)
Emerging leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology
Contact InformationJackie Marcus or Chris Hodges
Alpha IR GroupPhone: 312-445-2870
Email: INSY@alpha-ir.comwww.insysrx.com
(Nasdaq: INSY)