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Company Mission
MISSION
INSYS Therapeutics is a specialty pharmaceutical company that develops and
commercializes innovative drugs and novel drug delivery systems for therapeutic
molecules that improve the quality of patients' lives.
Using our proprietary sublingual spray technology and our capabilities to develop
pharmaceutical cannabinoids, we work to address the clinical shortcomings of existing
commercial products.
Company Highlights
Vertically integrated specialty pharmaceutical company focused on
supportive care indications
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Two Drug Development Platforms
PHARMACEUTICAL CANNABINOIDS
Dronabinol oral solution candidate, Syndros,
to be positioned as a best-in-class
pharmaceutical THC product
Emerging cannabidiol (CBD) product pipeline
only active DMF for pharmaceutical CBD
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Insys Pipeline Overview: An Emphasis on R&D
Pre-
Drug Candidate Disease State Phase 1 Phase 2 Phase 3 Submit Approval
Clinical
Opioid nave and Cancer
Subsys Label Expansion indications Dose Ranging Studies Completed
Buprenorphine
Acute Pain Phase 3 Completed
Sublingual Spray
Buprenorphine / Naloxone In Development
Opioid Dependence
Sublingual Spray
Naloxone Sublingual Spray Opioid Antagonist In Development
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Spray Technology Multiple Growth Opportunities
Download this awesome
diagram. Capture your
audiences attention.
Fentanyl/
Naloxone Naloxone
Buprenorphine/ Ondansetron
Naloxone
Buprenorphine Subsys
Epinephrine Sildenafil
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Subsys Sublingual Fentanyl Spray
1. Symphony Health Analytics, based on Average Wholesale Price (AWP) from December 2015 through November 2016
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Subsys Lifecycle Management: Potential Indications
Securing the longevity of the Subsys franchise
Post-
Operative
Complex
Burn
Regional
Dressing
Pain
Potential Changes
Syndrome
Opioid Nave and
Cancer Indications
Bone
Radiation
Marrow
Oncology
Biopsy
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Dose-selection for Studies in Opioid-Nave Population:
Single Ascending Dose Study
Subsys dose escalation
100 mcg x 1
200 mcg x 1
400 mcg x 1 800 mcg
600 mcg x 1
800 mcg x 1
Comparator: 600 mcg
Fentanyl 50 ug i.v. x 1
400 mcg
200 mcg
Study Completed:
100 mcg Subsys generally well tolerated
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Dose-selection for Studies in Opioid-Nave Population:
Multiple Ascending Dose Study
Doses (100, 200, 400 mcg)
Subsys q 4 hours x 3 doses
0 4 8 12 hours
=Dose
0 4 8 12 hours
0 4 8 12 hours
Subsys q 30 minutes x 3 doses
=Dose
=Dose
=Dose
0 4 8 12 hours
Comparator: Fentanyl i.v. 50 ug
Study Completed:
Subsys generally well tolerated
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Summary: Dose-selection for Indications in Opioid-Nave Population
Single Ascending
Subsys generally well tolerated
Dose Study
Multiple Ascending
Subsys generally well tolerated
Dose Study
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Potential Additional Indication
Reduction of pain associated with a BONE MARROW BIOPSY procedure
Phase 3 Endpoints
Significant limitations with pain
management options during BMB Summed Pain
Multi-center,
Bone e.g. local anesthetics, sedatives,
randomized, Intensity Difference
inhalation anesthetics
Marrow placebo- Score
Pain during bone marrow biopsy controlled trial
Biopsy (BMB) under local anesthesia (LA) Patient Assessments
is reported in 70% of patients (35%
-severe pain)1
1Lidn,
Y., Landgren, O., Arnr, S., SJlund, K.-F. and JohanssoN, E. (2009), Procedure-related pain among adult patients with hematologic malignancies. Acta
Anaesthesiologica Scandinavica, 53: 354363.
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Bone Marrow Procedures Study Design
Phase 3, Double-blind, Placebo Controlled
Study Medication administered prior to procedure
N = 150
Endpoints
Group A: 200 mcg
Timeline
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Protocol submitted to FDA: 4Q 2016
Study Initiation: 1H 2017 (pending FDA feedback)
Potential Additional Indication
Reduction of pain associated with a DRESSING CHANGES for BURN INJURIES
Phase 3 Endpoints
1 National
Hospital Ambulatory Medical Care Survey: 2011 Emergency Department Summary Tables
2American Burn Association National Burn Repository;National Inpatient Sample (HCUP-NIS: 2010 data); National Hospital Discharge Survey (2010 data); recent
100% hospitalization data from several states.
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Burn Dressing Changes Study Design
Phase 3, Double-blind, Placebo Controlled
Study Medication administered prior to procedure
N = 150
Treatment Visit
Endpoints
Group A: 200 mcg
Primary: Summed
N =96 Pain intensity
difference (SPID)
Group B: Placebo
Timeline
Submitted Protocol to FDA: 4Q 2016
Study Initiation: 1H 2017 (pending FDA feedback)
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Potential Additional Indication
Reduction of Anticipated Pain in a Radiotherapy Setting
Opioid Naive
SUBSYS 200 mcg
R
Screening Visit
Opioid Naive
PLACEBO Primary Endpoint:
N= 120 - Summed Pain intensity difference
(SPID)
Opioid Tolerant
SUBSYS 400 mcg
R
Day -14 Opioid Tolerant
PLACEBO
Timeline
File IND: 1H 2017
Study Initiation: 2H 2017 (pending FDA feedback)
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Cannabinoids - Growth Strategy
Syndros
Approved July 2016 for Nausea /
Vomiting Associated with Cancer
Chemotherapy and Anorexia / Weight
Loss in Patients with AIDS
Cannabidiol
Pediatric Epilepsies
Addiction
PTSD
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Syndros Commercial Opportunity
Market Trends Prescriber Overview1,4
5% annual market growth rate over the
past 3 years1
Growing market with no existing brand or
current promotional activity
45% 55%
Concentrated universe of ~9,500
prescribers write 70% of prescriptions2
Two-pronged sales and marketing
strategy:
Opportunity
Convert existing market $525 M gross sales
opportunity at brand pricing3
Expand usage through direct detailing to Peak Sales potential in excess of $200M
physicians - highlighting improved product profile
NIH (dailymed website) (1) 2012-2014 Health Source Analytics TRx data (2) 2015 Symphony Health Solutions TRx data (3) IMS Health and Medispan (4)
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Dronabinol Prescribers 2014
Dronabinol Lifecycle Management
Potential Indication:
Treatment of agitation in Alzheimer's Disease
Estimated 5.2 million people with Alzheimers disease in the United States
Incidence rates of agitation in patients with mild-to-moderate Alzheimers
disease are 20% to 40% after one year and up to 50% to 60% after two
years**
Primary predictor of nursing home placement (family members can no
longer handle care at home)
More rapid disease progression
N = 166
7.5 mg/day
Blinded titration
Screening Visit
Randomized
Placebo
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Cannabidiol: Addressing Unmet Medical Needs
Six Orphan
Epilepsy and Other Indications
Drug Designations Granted
Pediatric Schizophrenia
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Insys Financial Snapshot
Cash flow generated will fund future growth
$217.2 million in cash, cash equivalents & investments as of September 30, 2016
No debt
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Growth Strategy
Life Cycle
Management
Advancing 4 Subsys
programs
Advancing 3 Syndros
programs
Publications for Subsys
and Syndros
New Products
CBD- Multiple new
indications targeted
Multiple sublingual
sprays in development
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Insys Investment Highlights
Significant near-term organic growth drivers over the next five years
Strong intellectual property protection and barriers to entry for both product
platforms
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