N a s d a q : I N S Y

Transcription

1 N a s d a q : I N S Y Michael L. Babich, President and Chief Executive Officer Darryl S. Baker, Chief Financial Officer Jeffries Healthcare Conference, June 2014

2 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. 1

3 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 New products + potential additional indications for Subsys 2

4 Two Product Platforms 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 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 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) 3

5 Subsys Sublingual Fentanyl Spray 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 market 2 5 minute onset of action Seven doses from 100 to 1,600mcg Simple one-step administration process takes <1 minute 1 Based on gross sales of TIRF products in 2013 (Source: Symphony Health Solutions) 2 Data as of April 2014 (Source: IMS) 4

6 Rapid Onset Opioid Market Trend & Share Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 Dec-11 Jan-12 Feb-12 Mar-12 Apr-12 May-12 Jun-12 Jul-12 Aug-12 Sep-12 Oct-12 Nov-12 Dec-12 Jan-13 Feb-13 Mar-13 Apr-13 May-13 Jun-13 Jul-13 Aug-13 Sep-13 Oct-13 Nov-13 Dec-13 Jan-14 Feb-14 TRx ROO Market has stabilized since Q4 12 and has grown to ~13,000 TRx in Q ONSOLIS LAZANDA ABSTRAL ACTIQ FENTANYL CITRATE FENTORA SUBSYS Market Share Abstral: 7% OTFC: 30% Fentora: 20% Subsys: 41.6% All Others: ~ 2% 0 1 Source: Symphony Health Solutions 5

7 Subsys Increasing Market Penetration Subsys Continues to Gain Market Share 2 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 1 1 Twelve months ended 31 Dec Data as of April 2014 (Source: IMS Health) 6

8 Subsys Efficacy Data 5 Minute Onset of Pain Relief Pivotal Efficacy Trial Results Summed Pain Intensity Differences (SPID) Over Time Minutes: 5 Min 10 Min 15 Min 30 Min* 45 Min 60 Min Subsys SPID ,122 1,649 Placebo SPID P-Value P = P = P< P< P< P< 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, *Primary endpoint p-value is derived from ANCOVA with a dependent variable of SPID t 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 7

9 Subsys Has a Differentiated Product Profile 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 min, buccal tablet Dose Range 100g 1,600g 200g 1,600g 100g 800g Sugar Content None Yes None 1 Statistically significant 2 Prescribing Information for Subsys, Actiq and Fentora 8

10 Subsys Offers Most Complete Range of Strengths Brand (Company) U.S. Status (Approval Date) Route of Administration 100 µg 200 µg 400 µg 600 µg 800 µg 1,200 µg 1,600 µg Marketed (1/4/2012) Sublingual Spray Actiq (Teva, multiple generics) Marketed (11/4/1998) Lozenge Fentora (Teva) Marketed (9/25/2006) Buccal Tablet Onsolis (BDSI/Meda) Marketed (7/16/2009) Buccal Soluble Film Abstral (Galena) Lazanda (Depomed) Marketed (1/7/2011) Marketed (6/30/2011) Sublingual Tablet Nasal Spray Sources: Product labels and company websites Note: Check denotes doses for which each product is available 9

11 R & D Pipeline: Sublingual Spray Technology Preclinical Phase 1 Phase 2 Phase 3 Phase 4 Sublingual Spray Platform Buprenorphine (semi-synthetic opioid) Buprenorphine/Naloxone (opioid antagonist) INDs targeted for 2H 2014 Ondansetron (serotonin 5-HT3 receptor antagonist) Sildenafil (API in Viagra) Diclofenac (NSAID) Ketorolac (NSAID) Label Expansion Opportunities Dyspnea (incidental shortness of breath) Pre-procedural use in a clinical setting IND filed ER situations: acute pain ER situations: oncology To manage pain in burn patients Pediatric use 10

12 R & D Pipeline: Sublingual Spray Technology Buprenorphine Buprenorphine/ Naloxone Ondansetron Therapeutic Area Pain Opioid Addiction Nausea and Vomiting Market Size (US 2013) $3.6B 1 $1.7B 2 $4.1B 3 IND Filing 4 2H H H 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 11

13 Pharmaceutical Cannabinoids 12

14 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

15 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 Status More rapid absorption Less variability Flexible dosing Pre-NDA discussion with the FDA Pivotal bioequivalence clinical trial 2012 Clinical dossier complete Q NDA submission expected in 2H Clinical data from pivotal 52-patient crossover bioavailability and pharmacokinetics study completed in

16 Dronabinol Oral Solution Key Attributes % of Subjects Coefficient of Variability (AUC) Clinical Data from 52-Patient Crossover Bioavailability and PK Study Oral Solution Marinol Rapid Absorption 100% 80% 60% 40% Subjects achieving detectable plasma levels at 15 minutes Oral Solution: 100% 20% 0% Hours Marinol: <25% 37% Less Dose-to-Dose Variability 14% Oral Solution reduced intra-patient variability by more than 60% (as measured by AUC) Oral Solution Marinol Enables Flexibility in Dosing Source: 52-patient crossover study completed in 2012 Versatile Liquid Formulation Current formulations limited to 2.5mg, 5.0mg & 10.0mg capsules 15

17 R & D Pipeline: Pharmaceutical Cannabinoids Preclinical Phase 1 Phase 2 Phase 3 Phase 4 Dronabinol Dronabinol Oral Solution 2014 NDA submission planned by 2H Pharmaceutical Cannabidiol Pharmaceutical Cannabidiol (CBD): Epilepsy CBD: Peripheral neuropathy in taxol-treated patients CBD: Addiction in cocaine, heroin & opioids One or more INDs targeted for 2H 2014 CBD: Glioblastoma 16

18 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 Q %+ 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 and other pharmaceutical CBD, assuming FDA approval of product candidates 17

19 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 Market 1 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 1 Based on gross sales of TIRF products in 2013 (Source: Symphony Health Solutions) 18

20 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 New products + potential additional indications for Subsys 19

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