N a s d a q : I N S Y
Michael L. Babich, President and Chief Executive Officer Darryl S. Baker, Chief Financial Officer
Safe Harbor Statement
This presentation contains forward-looking statements.
These 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.
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, compliance with post-approval regulatory requirements and the
Company’s need to potentially obtain additional financing to successfully commercialize or further develop its existing products and product candidates. 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.
The company undertakes no obligation to publicly update or revise any forward-looking statements, except as may be required by law.
Investment Highlights
Commercial-stage specialty pharmaceutical company focused on innovative
supportive care products
Subsys®: Proprietary sublingual fentanyl spray for breakthrough pain in cancer patients
Launched in March 2012 through Insys sales force
Over 37% market share
Proprietary, oral dronabinol solution: clinical dossier complete for planned NDA
submission; completion of human abuse study pending
Pipeline:
Scalable pharmaceutical cannabinioid candidates for multiple commercial
applications
Multiple future applications of spray technology in development
Well-defined markets lacking innovation with significant patient needs
Known molecules – 505(b)(2) pathway
Sublingual Spray Technology
Pharmaceutical Cannabinoids
Delivers drug particles via a fine mist
across broad surface area of highly permeable membrane under tongue
Suitable for numerous molecules in our
target markets
First sublingual spray product, Subsys
(fentanyl sublingual spray), in-market since March 2012
Multiple preclinical products being
developed - 505(b)(2) pathway
2 Represents U.S. gross sales of dronabinol products in 2012 (IMS Health)
3 Based on market share gain between March 2012 through Feb 2014 (Source Healthcare Analytics)
Dronabinol SG Capsule in market
Clinical dossier complete for proprietary
dronabinol oral solution NDA submission
Opportunity to expand market through
improved formulations; completion of human abuse study pending
Multiple preclinical pharmaceutical
cannabinoids in pipeline
In-house API manufacturing capabilities
Subsys – Sublingual Fentanyl Spray
1 Based on gross sales of TIRF products in 2013 (Source: Symphony Health Solutions) 2 Data as of April 2014 (Source: IMS)
Indicated for breakthrough pain in
opioid-tolerant cancer patients
Total 2013 TIRF U.S. Sales of $422 million
1 Launched March 2012
Achieved 37.5% TIRF market share as of April
2014 (Rx basis)
2 Largest product in TIRF market2
5 minute onset of action
Seven doses from 100 to 1,600mcg
Simple
one-step administration process takes <1
Rapid Onset Opioid Market Trend & Share
0 2000 4000 6000 8000 10000 12000 14000 16000 Ju l-1 1 Au g-1 1 Sep -1 1 Oc t-1 1 No v-1 1 D ec -1 1 Ja n-1 2 Feb -1 2 M ar -1 2 Ap r-1 2 M ay-12 Ju n-1 2 Ju l-1 2 Au g-1 2 Se p-1 2 Oc t-1 2 No v-1 2 D ec -1 2 Ja n-1 3 Feb -1 3 M ar -1 3 Ap r-1 3 M ay-13 Ju n-1 3 Ju l-1 3 Au g-1 3 Se p-1 3 Oc t-1 3 No v-1 3 D ec -1 3 Ja n-1 4 Feb -1 4ONSOLIS LAZANDA ABSTRAL ACTIQ FENTANYL CITRATE FENTORA SUBSYS
Market Share
TRx Fentora: 20% OTFC: 30% Subsys: 41.6% All Others: ~ 2% Abstral: 7%ROO Market has stabilized since Q4’12 and has grown to
~13,000 TRx in Q1’14
1Subsys Increasing Market Penetration
Repeat patients increasing steadily
Over 95% commercial coverage
Tier 3 under nearly all major commercial health insurance plans Only branded TIRF product on United Healthcare formulary
Subsys FY 2013 net product revenue of $95.8 MM
1Subsys Continues to Gain Market Share
21 Twelve months ended 31 Dec 2013 2 Data as of April 2014 (Source: IMS Health)
Subsys Efficacy Data – 5 Minute Onset of Pain Relief
Pivotal Efficacy Trial Results – Summed Pain Intensity Differences (SPID) Over Time
Source: 130-patient pivotal Phase 3 efficacy trial presented in May 2011 at the Annual American Pain Society Conference; published in Current Medical Research & Opinion, Vol 28, No. 5, 2012, 859-870. *Primary endpoint
p-value is derived from ANCOVA with a dependent variable of SPIDt treatment difference and covariate of subject’s mean baseline pain intensity values over all treated episodes
Subsys Phase 3 Clinical Program:
300-patient safety trial and 130-patient safety and efficacy trial
SPID values at all points in time were significantly improved compared to placebo
All secondary endpoints (including SPID 5 through 60) were also achieved
Minutes: 5 Min 10 Min 15 Min 30 Min* 45 Min 60 Min
Subsys SPID 40 115 221 640 1,122 1,649
Placebo SPID 32 81 150 400 667 966
Subsys Actiq Fentora
Time to Relief 1,2 5 min 15 min 15 min
Bioavailability 76% 50% 65% Administration 1 <1 min, sublingual spray Up to 15 min, sublingual lozenge 14-25 min, buccal tablet Dose Range 100g – 1,600g 200g – 1,600g 100g – 800g
Sugar Content None Yes None
Subsys Has a Differentiated Product Profile
1 Statistically significant
U.S. Status (Approval Date) Route of Administration 200 µg 400 µg 600 µg 800 µg 1,200 µg 1,600 µg Marketed (1/4/2012) Sublingual Spray
Marketed (6/30/2011) Nasal Spray
Marketed (1/7/2011) Sublingual Tablet
Marketed(7/16/2009) Buccal Soluble Film Marketed (9/25/2006) Buccal Tablet Marketed (11/4/1998) Lozenge
Sources: Product labels and company websites
Note: Check denotes doses for which each product is available
Actiq (Teva, multiple generics) Fentora (Teva) Onsolis (BDSI/Meda) Abstral (Galena) Lazanda (Depomed) 100 µg
Subsys Offers Most Complete Range of Strengths
Brand (Company)
R & D Pipeline: Sublingual Spray Technology
Preclinical Phase 1 Phase 2 Phase 3 Phase 4
INDs targeted for 2H 2014 Buprenorphine (semi-synthetic opioid)
Buprenorphine/Naloxone (opioid antagonist)
Sildenafil (API in Viagra) Diclofenac (NSAID)
Ketorolac (NSAID)
Ondansetron (serotonin 5-HT3 receptor antagonist) Sublingual Spray Platform
Dyspnea (incidental shortness of breath) Pre-procedural use in a clinical setting
ER situations: oncology
To manage pain in burn patients Pediatric use
ER situations: acute pain
Label Expansion Opportunities
Buprenorphine Buprenorphine/
Naloxone Ondansetron
Therapeutic Area Pain Opioid Addiction Nausea and
Vomiting
Market Size
(US 2013) $3.6B
1 $1.7B2 $4.1B3
IND Filing4 2H 2014 2H 2014 2H 2014
1 Source: Symphony Health Solutions; estimated 2013 US $ Wholesale Acquisition Cost (WAC) of a basket of the short and long acting opioids, combination opioids and patches all indicated for pain.
2 Source: Symphony Health Solutions; estimated 2013 US $ WAC sales of Buprenorphine/Naloxone products including Suboxone (film and orally disintegrating tablet or ODT), generic Buprenorphine sublingual tablet, Zubsolv. 3 Source: Symphony Health Solutions; estimated 2013 US $ WAC sales of all Ondansetron products including Zofran, it’s generic (tablet, ODT, Oral Solution, Injectable) and Zuplenz (Oral Film).
4 Estimated
Dronabinol Synthetic Delta-9 Tetrahydrocannibinol
Marinol® (Schedule III controlled substance) approved in 1985
Indications:
Chemotherapy induced nausea and vomiting (CINV)
Anorexia associated with weight loss in patients with AIDS
$135 million in 2012 U.S. product sales
1
Growing despite generic competition, lack of promotion
Significant limitations:
Delayed absorption
Highly variable
Lack of flexibility in dosing
1 Source: IMS Health
Insys received approval for generic dronabinol in August 2011
Launched Dronabinol SG Capsule in December 2011
Insys Proprietary Dronabinol Product Franchise
Improved formulation provides opportunity to penetrate & expand dronabinol
market
Lead program: Dronabinol Oral Solution
Clinically demonstrated advantages versus Marinol
1 More rapid absorption
Less variability
Flexible dosing
Status
Pre-NDA discussion with the FDA
Pivotal bioequivalence clinical trial 2012
Clinical dossier complete Q3 2013
NDA submission expected in 2H 2014
Dronabinol Oral Solution Key Attributes
Source: 52-patient crossover study completed in 2012 Rapid Absorption
Less Dose-to-Dose Variability
Enables Flexibility in Dosing
Clinical Data from 52-Patient Crossover Bioavailability and PK Study
Subjects achieving detectable
plasma levels at 15 minutes
Oral Solution: 100% Marinol: <25%
Oral Solution reduced
intra-patient variability by more than 60% (as measured by AUC)
Current formulations limited to
2.5mg, 5.0mg & 10.0mg capsules 0% 20% 40% 60% 80% 100% 0 0.25 0.50 0.75 1.0 1.5 2.0 2.5 3.0 3.5 4.0 % o f Su b je cts Hours Oral Solution Marinol
Versatile Liquid Formulation
14%
37%
Oral Solution Marinol
Co eff ici en t of Va ri ab ili ty (AU C)
R & D Pipeline: Pharmaceutical Cannabinoids
Preclinical Phase 1 Phase 2 Phase 3 Phase 4
Dronabinol Oral Solution NDA submission planned by 2H
2014
One or more INDs targeted for 2H 2014 CBD: Addiction in cocaine, heroin & opioids
Pharmaceutical Cannabidiol (CBD): Epilepsy
CBD: Peripheral neuropathy in taxol-treated patients
CBD: Glioblastoma Dronabinol
R&D Pipeline: Pharmaceutical Cannabidiol (CBD)
Pursuing four INDs with FDA for pharmaceutical CBD
Synthetically produced in a controlled environment – Received Drug Master File
(DMF) #28255 from the FDA in Q2 2014
99%+ pure cannabidiol
Advancing our pharmaceutical CBD program for the treatment of epilepsy
Engaged large international CRO to provide development and regulatory services
Targeting treatment of Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome,
severe forms of childhood-onset epilepsy
Seeking orphan drug designations for all indications that qualify
Evaluating potential utility of pharmaceutical CBD in several other indications
Expanding manufacturing capacity to support future demand
Building second facility to support anticipated demand for dronabinol oral solution
Investment Considerations
Scalable pipeline of pharmaceutical CBD candidates for multiple commercial
applications
Epilepsy; peripheral neuropathy in taxol-treated patients; addiction in cocaine,
heroin & opioids; glioblastoma
Significant opportunity for Subsys revenue growth
Further penetration of $422MM TIRF Market1
Potential for label expansion to include additional indications
Broaden revenue stream through new innovative product introductions
Near-term opportunity: Dronabinol Oral Solution
Multiple future applications of spray technology in development
INDs targeted for 2014 for Buprenorphine, Buprenorphine/Naloxone,
Ondansetron
Profitable commercial-stage specialty pharmaceutical company
Investment Highlights
Commercial-stage specialty pharmaceutical company focused on innovative
supportive care products
Subsys®: Proprietary sublingual fentanyl spray for breakthrough pain in cancer patients
Launched in March 2012 through Insys sales force
Over 37% market share
Proprietary, oral dronabinol solution: clinical dossier complete for planned NDA
submission; completion of human abuse study pending
Pipeline:
Scalable pharmaceutical cannabinioid candidates for multiple commercial
applications
Multiple future applications of spray technology in development
Well-defined markets lacking innovation with significant patient needs
Known molecules – 505(b)(2) pathway
