(Nasdaq: INSY) › system › files-encrypted › nasdaq...2018/10/02  · Key Facts NASDAQ INSY...

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Investor Presentation Cantor Global Healthcare Conference October 2, 2018 (Nasdaq: INSY)

Transcript of (Nasdaq: INSY) › system › files-encrypted › nasdaq...2018/10/02  · Key Facts NASDAQ INSY...

Page 1: (Nasdaq: INSY) › system › files-encrypted › nasdaq...2018/10/02  · Key Facts NASDAQ INSY Founded 2002 Headquarters Chandler, AZ TTM Revenue* $110M Cash on Hand* $124M R&D Investment

Investor PresentationCantor Global Healthcare Conference

October 2, 2018

(Nasdaq: INSY)

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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 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.

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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

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Two Innovative Drug Development Platforms

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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

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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)

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Strategic Roadmap & Key Priorities

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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

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Legal Landscape

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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

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Strengthen the Foundation & Enhance Execution

2

New Leadership Across the Organization

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▪ ~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

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Unique Manufacturing Capabilities

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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

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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**

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Pipeline Priority and Valuation

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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

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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

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Completed CBD Trial INS011-14-029

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• 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

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INS011-14-029: High-Level Result Summary

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• 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

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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

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• 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

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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

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Collaborative CBD Trials Under Consideration

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▪ 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

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Epinephrine Nasal Spray: Fast Tracked

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▪ 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)

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▪ 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

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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.

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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

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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

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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

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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

Page 25: (Nasdaq: INSY) › system › files-encrypted › nasdaq...2018/10/02  · Key Facts NASDAQ INSY Founded 2002 Headquarters Chandler, AZ TTM Revenue* $110M Cash on Hand* $124M R&D Investment

Contact InformationJackie Marcus or Chris Hodges

Alpha IR GroupPhone: 312-445-2870

Email: [email protected]

(Nasdaq: INSY)