Investor Presentation

Transcription

1 (Nasdaq: INSY) Investor Presentation Janney Healthcare Conference September 18, 2018

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. 2

3 Investment Thesis NASDAQ Key Facts INSY Emerging leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology Founded 2002 Headquarters Chandler, AZ TTM Revenue * $110M Cash on Hand * $124M 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 R&D Investment ~$250M since 14 Deep, well-differentiated pipeline across cannabinoids and spray platforms Potential for at least five NDAs through 2021 Two FDA-approved products available in U.S. SUBSYS (fentanyl sublingual spray) launched in 2012 SYNDROS (dronabinol) oral solution launched in 2017 *as of 6/30/18 Unique 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) 3

4 Two Innovative Drug Development Platforms Oral Solution Inhalation 1) Pharmaceutical Cannabinoids SYNDROS Pharmaceutical THC Oral Solution Product Oral Solution Delivery (launched Aug 17) Inhalation Delivery (in development) Early Stage Cannabidiol (CBD) Product Pipeline Oral Solution Delivery (in development) Disease States Under Investigation Childhood Absence Epilepsy Infantile Spasms Prader-Willi-Syndrome Anorexia in Cancer Sublingual 2) Spray Technology Nasal 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 4

5 Two FDA-Approved Commercial Products 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 share 1 ~28% Unit share 1 ~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 Q Exploring label expansion (anorexia in cancer) 1 Exit share as of August 2018 (source: IQVIA) 5

6 Strategic Roadmap & Key Priorities Our Vision 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 Priorities Resolve Government Investigations & Rebuild Reputation Building new culture of compliance and ethics Reached agreement in principle with DOJ Strengthen the Foundation & Enhance Execution Recruiting & retaining people of character & experience Augmenting capabilities & optimizing processes Advance and Develop Diverse Pipeline to Drive Future Growth Shifting from opioids to cannabinoids Three major programs underway in CBD Exploring collaborative research partnerships Stabilize and Grow Marketed Portfolio Sales Force talent upgrade & realignment Expanding managed care contracts & patient services Exploring international expansion Supported by: Strong Culture of Compliance 6

7 Legal Landscape 1 1) Department of Justice Resolve Government Investigations & Rebuild Reputation Settlement Agreement in Principle as of August 8, 2018 $150 million payable over five years Management estimate of $0 to $75 million in potential contingencybased 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 7

8 New Leadership Across the Organization Saeed Motahari President & CEO 20-year veteran in the life sciences industry Hoffmann-La Roche Bristol-Myers Squibb Abbott Laboratories & AbbVie Purdue Pharma Executive Leadership Andy Long Chief Financial Officer 30+ years in financial leadership positions across bio pharma, life sciences, and industrial sectors Patheon Thermo Fisher Abbott Laboratories Executive Leadership Dr. Ahmed Elkashef, M.D. Vice President of 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 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 2 Strengthen the Foundation & Enhance Execution ~40% of current employees have less tenure than CEO Brian Jennings VP, Sales Carol Summersgill VP Human Resources Ariyapadi Krishnaraj VP, Commercial Scott Warlick General Manager & Director of Manufacturing ~50% of current sales reps joined INSYS in 2017 and years of industry experience Purdue Pharma Publicis Healthcare Group Sanofi Roche U.S. (Genentech) Unimed 20+ years of HR leadership Libbey Inc. Philosophy, Inc. Therma-Tru Doors, Inc. Whirlpool Corp. 30+ years in industry and consulting experience Iroko Pharmaceuticals Novartis GlaxoSmithKline Consultant: Endo & Takeda 15+ years in site management, operations, maintenance, process engineering/optimization Mylan Mallinckrodt More than two-thirds of company s Board is new since April 2017 Executive Leadership Executive Leadership Executive Leadership Manufacturing 8

9 Unique Manufacturing Capabilities 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: 2 Strengthen the Foundation & Enhance Execution 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 9

10 Continued Commitment to R&D & Patients ~$250 million invested since 2014 in R&D pipeline to drive future growth 3 Advance and Develop Diverse Pipeline to Drive Future Growth R&D Expense (millions) $57 $74 $63 $33 $29 $6 $ H

11 SPRAYS CANNABINOIDS Deep Pipeline to Drive Long-Term Growth Drug Candidate Disease State Non-Clinical Phase 1 Phase 2 Phase 3 Submit Approval (i) Childhood Absence Epilepsy Ph 2 Enrolling (n=30) Cannabidiol (CBD) Oral Solution (ii) Infantile Spasms Ph 3 Initiated (n=190) (iii) Prader-Willi Syndrome Ph 2 Enrolling (n=66) Fast Track Designation Granted Dec 2017 Dronabinol Inhalation Anorexia in Cancer In Dev IND Accepted April 2018; PK Study 2H 18 Naloxone* Nasal Spray Opioid Overdose PK Completed Epinephrine* Nasal Spray Anaphylaxis PK Completed Fast Track Designation Granted Aug 2018 Buprenorphine/Naloxone Sublingual Spray Opioid Dependence In Dev Buprenorphine Sublingual Spray Moderate-to-Severe Acute Pain NDA Filed CRL Rec d July 2018 * Pursuing 505(b)2 bioequivalence approach for potential approval 11

12 Pipeline Priority and Valuation Pipeline Project Assessment 1 Market Potential Ranking High 1) CBD Investment 2 Dronabinol Inhalation CBD Epinephrine 2) Epinephrine 3) Dronabinol Inhalation 4) Buprenorphine/Naloxone 5) Naloxone Medium to high market opportunity Low to medium market opportunity Bup/ Naloxone Naloxone Low Bup Early Project Status 3 Late 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

13 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 13

14 Completed CBD Trial INS 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 14

15 INS : High-Level Result Summary 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 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 American Epilepsy Society (AES) Meeting Q Abstract presentation : Long-Term Safety of Pharmaceutical Cannabidiol Oral Solution as Adjunctive Treatment for Pediatric Patients With Treatment-Resistant Epilepsy 15

16 Ongoing CBD Clinical Trials Infantile Spasms Child Absence Epilepsy Prader-Willi Syndrome Orphan drug status granted July 2015 Onset age: 1 24 months EEG shows hypsarrhythmia Prevalence: 98,062 children Usually staring spells lasting seconds 2% 8% of people with epilepsy Two-thirds with CAE respond to treatment Prevalence: 9,400 37,600 children 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 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. * 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 16

17 CBD Clinical Trials - Phase 3 Infantile Spasms 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 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 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 17

18 Collaborative CBD Trials Under Consideration Autism Early Psychosis Anorexia Nervosa Childhood Schizophrenia/ Early Psychosis Collaborating with University of California San Diego School of Medicine s Center for Medicinal Cannabis Research Orphan Drug Designation Possible collaboration with NIMH Addiction Possible collaboration with NIDA and NIAAA Post-Traumatic Stress Disorder Possible collaboration with DOD and VA 18

19 Epinephrine Nasal Spray: Fast Tracked 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 year 1 Worldwide prevalence: lifetime risk globally per person of 0.5 2% 2 ~$1.7 billion U.S. market in 2017 with ~25% CAGR ( ) 3 Epinephrine is most important medicine to give during life-threatening anaphylaxis 4 Current epinephrine products are all invasive Supply shortage of auto-injectors / injectables in U.S. Meaningful clinical opportunity for potential nasal spray American Academy of Allergy, Asthma & Immunology (AAAI) Annual Meeting 2019 Abstract submitted to present PK Study Data (pending acceptance) 1 Mayo Clinic, 2 World Allergy Organization, 3 IQVIA, 4 Symphony Health Solutions 19

20 Millions Naloxone: NDA Preparation Human Factors Study completed Naloxone Doses Ongoing nonclinical studies recently requested by FDA prior to NDA submission 6 5 NDA submission target date: Q to Q Strategy for filing 3 1. Fast Absorption 2 2. Higher Exposure (AUC) than all Narcan/Naloxone preparations 1 3. Longer duration (up to 2 hours) formulation to combat the rising epidemic of synthetic opioids overdose 0 12 months ended 6/30/16 12 months ended 6/30/17 12 months ended 6/30/18 Source: IQVIA NSP Audit 9/11/18 American Society of Addiction Medicine (ASAM) 2019 College on Problems of Drug Dependence (CPDD) 2019 Abstracts in development to present Naloxone PK study data 20

21 Key R&D Projects and Milestones Drug Candidate Targeted Indication Delivery Method Recent Milestones Upcoming Milestone Naloxone Opioid Overdose Nasal Spray End of Phase 2 FDA meeting (Feb 2018) Completed PK studies Nonclinical studies to be completed in 2018 NDA filing Q to Q Epinephrine Anaphylaxis Nasal Spray Childhood Absence Epilepsy Proof-of-concept study enrollment completed End of Phase 2 FDA meeting (Aug 2018) Enrolling Phase 2 study Designing confirmatory PK study Data read Q Cannabidiol (CBD) Infantile Spasms Oral Solution Enrolling Phase 3 study Data read Q Prader-Willi Syndrome Initiated and recruiting proof-of-concept study Received Fast Track designation (Dec 2017) Data read Q Dronabinol (THC) Anorexia in Cancer Inhalation Device Proof-of-concept PK study (healthy subjects) completed Data read Q

22 Projected NDA Timelines Epinephrine Anaphylaxis CBD Infantile Spasms CBD Prader-Willi Syndrome Naloxone* Opioid Overdose 2018 Dronabinol** Anorexia in Cancer CBD Childhood Absence Epilepsy 2020 ** Pending successful proof-of-concept study in late 2018 * NDA filing may shift to Q due to recent request from FDA for nonclinical studies 22

23 Commercial Strategies Overview 4,500 4,000 3,500 3,000 2,500 2,000 1,500 1, SUBSYS and TIRF Market TRxs as of August 2018 Executing SUBSYS Stabilization Initiatives Positive signs from managed care wins Health Educator program building confidence in doctors by ensuring appropriate patients will be educated on proper usage Increasing awareness of breakthrough cancer pain and TIRFs with HCPs treating breakthrough cancer pain associated with bone metastasis Exploring collaborative licensing opportunities internationally Stabilize and Grow Marketed Portfolio 4 All other TIRF SUBSYS SYNDROS Brand Awareness Programs Continued 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 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 Q net revenue of $1 million (56% sequential improvement) Continuing HCP education programs Pursuing additional managed care wins Market Share 30% 31% 30% 29% 27% 28% 27% 29% 28% 30% 28% 28% Source: IQVIA 23

24 Financial Snapshot $123.5M in cash at end of Q No debt Gross margins ~90% Revenue (millions) Optimizing operating expenses while fully funding R&D Rightsized commercial organization Leveraging supplier base Tight headcount controls Adjusted EBITDA (millions) $350 $300 $250 $200 $150 $100 $99.3 $219.1 $330.3 $242.3 $140.7 $140 $120 $100 $80 $60 $40 $20 $0 $40.6 $78.8 $128.3 $39.1 $50 $0 $ $20 -$40 -$60 -$17.3 -$

25 Investment Thesis Emerging leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology 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 Unique 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) 25

26 (Nasdaq: INSY) Contact Information Jackie Marcus or Chris Hodges Alpha IR Group Phone: