Disclosure. This presentation contains forward-looking statements.



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Forward Looking Statements

Transcription:

Disclosure 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 postapproval 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

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 Profitable operations in 1H 2013 with $29.9MM in net revenue Cost-efficient, incentive-based sales model Expected 2H 2013 NDA submission for proprietary, oral dronabinol solution Multiple future applications of spray technology being developed Experienced and successful management team and board - Lyphomed, Unimed, Alliant, Sciele, Akorn, Option Care 2

Two Product Platforms Sublingual Spray Technology Dronabinol Product Franchise Dronabinol SG Capsule $388MM TIRF U.S. Product Sales 1 $135MM U.S. Market Size 2 Fastest growing branded TIRF product 3 Spray technology suitable for numerous molecules in our target markets Multiple preclinical products being developed - 505(b)(2) pathway Expected 2H 2013 NDA submission for proprietary dronabinol oral solution Opportunity to expand market through improved formulations In-house API manufacturing capabilities Supportive care commercial organization targets concentrated prescriber base 1 Based on gross sales for Transmucosal Immediate-Release Fentanyl (TIRF) products in 2012 (Source Healthcare Analytics) 2 Represents U.S. gross sales of dronabinol products in 2012 (IMS Health) 3 Based on market share gain between March 2012 through May 2013 (Source Healthcare Analytics) 3

Differentiated Specialty Pharma Model Cost-Efficient Commercialization Targeted Development Highly focused Subsys incentive-based sales force Compensation weighted towards performance-based bonus Concentrated prescriber base Well-defined message Well-defined markets lacking innovation with significant patient needs Known molecules 505(b)(2) pathway Differentiated patient-friendly products Leverage supportive care commercial infrastructure Profitable within one year of Subsys launch 1 Product pipeline with potential for multiple IND submissions 1 Based upon net revenue exceeding total operating expense within first year of launch 4

5

Subsys Sublingual Fentanyl Spray Indicated for breakthrough pain in opioidtolerant cancer patients Total 2012 TIRF U.S. Sales of $388 million 1 Launched March 2012 Achieved 25.7% TIRF market share as of July 2013 (Rx basis) 2 Fastest growing prescribed branded TIRF product 3 Rapid onset of action, pain relief in 5 minutes Seven doses from 100 to 1,600mcg Simple one-step administration process takes <1 minute 1 Based on gross sales of TIRF products in 2012 (Source Healthcare Analytics) 2 Data as of July2013 (Source Healthcare Analytics) 3 Based on market share gain between March 2012 through July 2013 (Source Healthcare Analytics) 6

Subsys Market Experience Highlights Subsys Market Share and Demand Repeat patients increasing steadily Tier 3 under nearly all major commercial health insurance plans 35% 30% 25% 20% 15% Subsys TRx Subsys Share 25.7% 3000 2500 2000 1500 Commitment to improving patient access 10% 5% 0% 1000 500 0 2013 Subsys net product revenue of $28.2MM through June 30, 2013 Comparative Market Share 2 Other, 2% Fentora 31% Other, 1% Subsys, 10% Fentora 29% Other, 2% Subsys, 26% Fentora 26% Actiq & Generics 67% Actiq & Generics 60% Actiq & Generics 47% 1 Data as of July 2013 (Source Healthcare Analytics) 2 Other category includes Abstral, Onsolis and Lazanda (Source Healthcare Analytics) Q1 2012 Q4 2012 Q3 2013 (Jul) 7

Differentiated Product Profile Subsys Actiq Fentora Time to Relief 1,2 5 min 15 min 15 min Bioavailability 76% 50% 65% Administration 2 <1 min, sublingual spray Up to 15 min, oral lozenge 14-25 min, buccal tablet Dose Range 100μg - 1,600μg 200μg - 1,600μg 100μg - 800μg Sugar Content None Yes None Side Effects 3 Nausea, vomiting, constipation or dyspnea Asthenia, headache, nausea, vomiting, constipation, dizziness, anxiety, somnolence, confusion or dyspnea Anemia, nausea, vomiting, constipation, edema peripheral, asthenia, fatigue, dehydration, dizziness or headache 1 Statistically significant 2 Prescribing Information for Subsys, Actiq and Fentora 3 Adverse reactions which occurred during long-term treatment at a frequency of >10% 8

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 (Cephalon) Marketed (11/4/1998) Lozenge Fentora (Cephalon) Marketed (9/25/2006) Buccal Tablet Onsolis (BDSI/Meda) Marketed (7/16/2009) Buccal Soluble Film Abstral (Orexo AB) Lazanda (Archimedes) 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

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 40 115 221 640 1,122 1,649 Placebo SPID 32 81 150 400 667 966 P-Value P = 0.0219 P = 0.0001 P<0.0001 P<0.0001 P<0.0001 P<0.0001 Source: 130-patient pivotal Phase 3 efficacy trial presented in May 2011 at the Annual American Pain Society Conference *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 end points (including SPID 5 through 60) were also achieved 10

Successful Execution of the Subsys Launch Strategy ~1,680 physicians write 90% of TIRF prescriptions 2 Top 118 physicians write 30% of TIRF prescriptions 81% have written a Subsys prescription Profitable within one year of Subsys launch 1 Sales force expanded in 2013 Number of TIRF Prescribers by Decile 2 # Physicians 90% of TIRF prescriptions 118 409 1,153 3,572 Decile 10-8 Decile 7-5 Decile 4-2 Decile 1 1 Based upon net revenue exceeding total operating expense within first year of launch 2 Based on unit level data from May 2012 April 2013 post REMS (Source Healthcare Analytics) 3 Unit level data for December 2012 and July 2013 (Source Healthcare Analytics) % Market Share Change in Subsys Penetration 3 by Prescriber Decile, Dec 12 v Jul 13 Jul-13 36.6% +23.6% Dec-12 13.0% Jul-13 21.2% +14.7% Dec-12 6.5% Jul-13 13.6% +9.0% +10.5% Dec-12 4.6% Jul-13 15.1% Dec-12 4.6% Decile 10-8 Decile 7-5 Decile 4-2 Decile 1 11

Subsys Growth Drivers Continue market share gains in the $388MM TIRF Market 1 Leverage existing sales force to increase penetration of high prescribing physicians Titrate repeat patients to effective dose Grow patient access for Subsys through managed care Potential expansion of Subsys usage in additional indications 1 Based on gross sales of TIRF products in 2012 (Source Healthcare Analytics) 12

Dronabinol Product Franchise 13

Dronabinol Synthetic Delta-9 Tetrahydrocannibinol Dronabinol Overview Limitations of Marinol Marinol (Schedule III controlled substance) approved in 1985 Indicated for chemotherapy induced nausea and vomiting (CINV) and anorexia associated with weight loss in patients with AIDS $135 million in 2012 U.S. product sales 1 Delayed absorption Highly variable Lack of flexibility in dosing Dronabinol Total Prescriptions (Thousands) 1 273 290 312 321 320 2008 2009 2010 2011 2012 Received approval for generic dronabinol in August 2011 Launched SG capsule in December 2011 1 Source: IMS Health 14

Proprietary Dronabinol Product Franchise Oral solution NDA submission expected in 2H 2013 Improved formulation provides opportunity to penetrate and expand dronabinol market Potential future line extensions: Sublingual spray, IV and inhalation device Dronabinol Oral Solution Advantages Versus Marinol 1 More rapid absorption Less variability Flexible dosing Dronabinol Oral Solution Status Pre-NDA discussion with the FDA completed Pivotal bioequivalence clinical trial completed in 2012 Expected NDA submission in 2H 2013 1 Clinical data from pivotal 52-patient crossover bioavailability and pharmacokinetics study completed in 2012 15

Dronabinol Oral Solution Key Attributes Clinical Data from 52-Patient Crossover Bioavailability and PK Study Oral Solution Marinol Rapid Absorption % of Subjects 100% 80% 60% 40% 20% 0% 0 0.25 0.50 0.75 1.0 1.5 2.0 2.5 3.0 3.5 4.0 Hours Subjects achieving detectable plasma levels at 15 minutes Oral Solution: 100% Marinol: <25% 37% Less Dose-to-Dose Variability Coefficient of Variability (AUC) 14% 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 and 10.0mg capsules 16

Dronabinol Product Franchise Strategy Secured Captive Dronabinol API Source Established Market Presence Launch Proprietary Formulations Establish New Manufacturing Facility Schedule I controlled substance Significant barrier to entry Generic formulations Validated manufacturing capability and supply chain Improve product profile and expand the market Synergistic with supportive care sales force Support longterm API needs of proprietary dronabinol product Completed Completed 2H 2013 dronabinol oral solution NDA submission Complete second facility in 2014 (lease signed Q3 2013) 17

Dronabinol SG Capsule Summary Dronabinol SG Capsule Mylan Distribution Agreement Generic equivalent of Marinol Approved and launched in 2011 Currently distributed by Mylan 2012 net revenue of $6.9 million 1H 2013 net revenue of $1.7MM Date of Agreement Mylan Responsibilities Insys Responsibilities Shared Responsibilities Financial Terms May 2011 Product distribution and management of commercial relationships Manage dronabinol manufacturing and supply chain WAC pricing and distribution strategy 10% - 20% royalty and singledigit distribution and storage fee paid to Mylan 18

Multiple Opportunities for Growth Grow Subsys market share and revenues Continue to increase market share in the $388MM TIRF Market 1 Expand Subsys usage in additional indications Achieve FDA approval for Dronabinol Oral Solution and advance our proprietary dronabinol product pipeline Convert existing market to Dronabinol Oral Solution formulation, if approved Expand the market through improved clinical profile Pursue additional indications Drive profitability by leveraging our cost-efficient commercial organization with existing and future products Multiple future applications of spray technology being developed 1 Based on gross sales of TIRF products in 2012 (Source Healthcare Analytics) 19

Financial Summary Q2 2013 Q1 2013 % Increase Revenue $18.8 $11.1 69% Operating Profit $5.2 $0.8 550% Net Income $4.6 $0.1 Diluted Shares Outstanding 17.4 1.9 * Diluted EPS $0.26 $0.01 * Cash, Cash Equivalents $21.8 $0.7 * Debt - $70.4 * Does not reflect impact of May 2013 initial public offering 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 Profitable operations in 1H 2013 with $29.9MM in net revenue Cost-efficient, incentive-based sales model Expected 2H 2013 NDA submission for proprietary, oral dronabinol solution Multiple future applications of spray technology being developed Experienced and successful management team and board - Lyphomed, Unimed, Alliant, Sciele, Akorn, Option Care 21