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InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8...

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Page 1: InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8 - SYNDROS™ (dronabinol) oral Prescriber Overview1 solution, CII, approved for:

N a s d a q : I N S Y

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Page 2: InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8 - SYNDROS™ (dronabinol) oral Prescriber Overview1 solution, CII, approved for:

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 comply with post-approval regulatory and governmental requirements; the actual sales potential and opportunity of identified markets; 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.

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Page 3: InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8 - SYNDROS™ (dronabinol) oral Prescriber Overview1 solution, CII, approved for:

Saeed Motahari, President & CEO

- 20-year veteran of the life sciences industry

- 8 years at Hoffmann-La Roche and Bristol-Myers Squibb

• Led various functional areas in the commercial organization

- 10 year tenure at Abbott Laboratories & AbbVie

• Vice President of US Specialty Brands – New Launches

• P&L responsibility for Specialty Franchises in multiple therapeutic areas

- Purdue Pharma Chief Commercial Officer

• Led successful transformation of commercial organization

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Page 4: InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8 - SYNDROS™ (dronabinol) oral Prescriber Overview1 solution, CII, approved for:

Insys Highlights

- Differentiated products and novel proprietary drug platforms offer substantial room for growth

- Addressing underserved population of patients with breakthrough cancer pain with our market leading Subsys® sublingual spray

- Poised to launch SYNDROS™ (dronabinol) oral solution in August 2017

- Advancing deep pipeline with multiple opportunities to deliver long-term value in the business

- State of the art manufacturing capabilities for pharmaceutical cannabinoids

3

Page 5: InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8 - SYNDROS™ (dronabinol) oral Prescriber Overview1 solution, CII, approved for:

Strategic Roadmap

4

Mission

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

Strengthen the Foundation

Stabilize and Strengthen

Portfolio

Advance Our Pipeline

Resolve Government

Investigations

Strategic Imperatives

Page 6: InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8 - SYNDROS™ (dronabinol) oral Prescriber Overview1 solution, CII, approved for:

Strategic Imperatives

5

Strengthen the Foundation

• Optimize and align structure

• Strengthen commercial, medical and business partnership capabilities

• Recruit, Develop & Retain Talent

Stabilize and Strengthen

Portfolio

• Stabilize Subsys

• Launch SYNDROSTM

• Optimize Lifecycle initiatives for both products

Advance Our Pipeline

• Spray technology

• Cannabinoid platform

Resolve Government

Investigations

• Federal

• States

Page 7: InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8 - SYNDROS™ (dronabinol) oral Prescriber Overview1 solution, CII, approved for:

Leveraging Two Drug Delivery Platforms

Spray Technology

• Drug delivery via a fine mist:

• beneath the tongue (sublingual)

• in the nasal cavity (nasal)

• Targeting supportive care & other markets where spray product characteristics add value

• Ease of use / application

• Clinically beneficial faster speed of onset

Pharmaceutical Cannabinoids

• SYNDROS™ to be positioned as a best-in-class pharmaceutical THC product

• Emerging cannabidiol (CBD) product pipeline

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Page 8: InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8 - SYNDROS™ (dronabinol) oral Prescriber Overview1 solution, CII, approved for:

Subsys®

- Offering relief to patients with breakthrough cancer pain

• Onset of action as early as 5 minutes

• Seven doses from 100 to 1,600mcg

• Simple one-step administration process takes < 1 minute

- Market leader despite challenges to TIRF product class

- Market share stabilizing at ~35%

Opportunities to stabilize and grow the product

- Educating market about breakthrough cancer pain to improve treatment rate

- Improve access

- Improve adherence

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Page 9: InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8 - SYNDROS™ (dronabinol) oral Prescriber Overview1 solution, CII, approved for:

SYNDROS™ Commercial Opportunity

8

Prescriber Overview1- SYNDROS™ (dronabinol) oral solution, CII, approved for:

• Anorexia associated with weight loss in patients with AIDS

• Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments

- Current market at ~280k prescriptions2, with potential addressable population of ~800K in CINV and ~90k in AIDS anorexia

- Concentrated universe of ~4K prescribers write 50% of scripts

Preparing for August 2017 launch

(1) 2016 IMS TRx data (2) 2013-2016 Source Health Analytics TRx data

Page 10: InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8 - SYNDROS™ (dronabinol) oral Prescriber Overview1 solution, CII, approved for:

SYNDROS™ Commercial Strategy

- Position as a best-in-class pharmaceutical THC product

- Launch with existing sales force to concentrated universe of prescribers

- Two-pronged approach

1. Convert existing Marinol market

2. Expand the market

• Highlight improved product profile

- Hybrid distribution model – specialty pharma and retail

Peak SYNDROS™ sales potential >$200M

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Page 11: InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8 - SYNDROS™ (dronabinol) oral Prescriber Overview1 solution, CII, approved for:

Deep Pipeline to Drive Long-Term Growth

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Drug Candidate Disease StatePre-

ClinicalPhase 1 Phase 2 Phase 3 Submit Approval

SU

BLIN

GU

AL S

PR

AY

S

Buprenorphine Sublingual Spray

Moderate to severePain

Subsys Label Expansion

Post operative pain and pre-procedural pain

Naloxone Nasal Spray Opioid Overdose

Buprenorphine / Naloxone Sublingual Spray

Opioid Dependence

Fentanyl / MentholBreakthrough cancer pain in patients ≥18 yo

EpinephrineAnaphylaxis Reaction

CA

NN

AB

INO

IDS Syndros

(i) CINV & (ii) anorexia associated with weight loss in patients with AIDS

Syndros Label Expansion

(i) Agitation in Alzheimer’s disease (ii) Anorexia

Cannabidiol(i) Epilepsy and other indications

Dose Ranging Studies Completed

Phase 3 Completed

In Development

Approved

In Development

PK Study in refractory epilepsy

completed

In Development

In Development

In Development

Page 12: InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8 - SYNDROS™ (dronabinol) oral Prescriber Overview1 solution, CII, approved for:

Cannabinoids - Growth Strategy

11CINV: chemotherapy induced nausea & vomiting

Cannabidiol

• Pediatric Epilepsies • Addiction & other indications

SYNDROSTM

• Approved –July 2016 for Nausea / Vomiting Associated with Cancer Chemotherapy and Anorexia / Weight Loss in Patients with AIDS

• Life Cycle Management• Alzheimer's Agitation• Anorexia in cancer patients• Inhaled delivery

Page 13: InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8 - SYNDROS™ (dronabinol) oral Prescriber Overview1 solution, CII, approved for:

Cannabinoid Manufacturing Capabilities

12

U.S.-based facility approved to produce pharmaceutical dronabinol (THC) and cannabidiol (CBD) with scale for commercial quantities

Expanding manufacturing capacity to support future demand

• Constructed second facility to manufacture API for dronabinol oral solution and pharmaceutical CBD

Capable of producing over 99% pure CBD synthetically in a controlled environment

Page 14: InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8 - SYNDROS™ (dronabinol) oral Prescriber Overview1 solution, CII, approved for:

- Cash flow generated will fund future growth

- $218.5 million in cash, cash equivalents & investments as of March 31, 2017

- No debt

Revenue ($mm) Adjusted EBITDA ($mm)

$15.5

$99.3

$219.1

$330.3

$242.3

$0

$50

$100

$150

$200

$250

$300

$350

2012 2013 2014 2015 2016

-$17.3

$40.6

$78.8

$128.3

$39.1

-$40

-$20

$0

$20

$40

$60

$80

$100

$120

$140

2012 2013 2014 2015 2016

Insys Financial Snapshot

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Page 15: InSys Therapeutics, Inc. - Jefferies Group Therapeutics … · SYNDROS™ Commercial Opportunity 8 - SYNDROS™ (dronabinol) oral Prescriber Overview1 solution, CII, approved for:

Insys Highlights

- Differentiated products and novel proprietary drug platforms offer substantial room for growth

- Addressing underserved population of patients with breakthrough cancer pain with our market leading Subsys® sublingual spray

- Poised to launch SYNDROS™ (dronabinol) oral solution in August 2017

- Advancing deep pipeline with multiple opportunities to deliver long-term value in the business

- State of the art manufacturing capabilities for pharmaceutical cannabinoids

14


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