InSys Therapeutics, Inc. - Jefferies · further develop its existing products and product...

21
Nasdaq: INSY Michael L. Babich, President and Chief Executive Officer Darryl S. Baker, Chief Financial Officer Jeffries Healthcare Conference, June 2014

Transcript of InSys Therapeutics, Inc. - Jefferies · further develop its existing products and product...

Page 1: InSys Therapeutics, Inc. - Jefferies · further develop its existing products and product candidates. For a further description of these and other risks facing Insys, please see the

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

Page 2: InSys Therapeutics, Inc. - Jefferies · further develop its existing products and product candidates. For a further description of these and other risks facing Insys, please see the

Safe Harbor Statement

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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.

Page 3: InSys Therapeutics, Inc. - Jefferies · further develop its existing products and product candidates. For a further description of these and other risks facing Insys, please see the

Investment Highlights

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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

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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

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)

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

Two Product Platforms

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Subsys – Sublingual Fentanyl Spray

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1 Based on gross sales of TIRF products in 2013 (Source: Symphony Health Solutions) 2 Data as of April 2014 (Source: IMS)

Indicated for breakthrough pain in opioid-tolerant cancer patients

Total 2013 TIRF U.S. Sales of $422 million1

Launched March 2012

Achieved 37.5% TIRF market share as of April 2014 (Rx basis)2

Largest product in TIRF market2

5 minute onset of action

Seven doses from 100 to 1,600mcg

Simple one-step administration process takes <1 minute

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Rapid Onset Opioid Market Trend & Share

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ONSOLIS LAZANDA ABSTRAL ACTIQ FENTANYL CITRATE FENTORA SUBSYS

Market Share

TRx

Fentora: 20%

OTFC: 30%

Subsys: 41.6%

All Others: ~ 2%

Abstral: 7%

ROO Market has stabilized since Q4’12 and has grown to

~13,000 TRx in Q1’141

1 Source: Symphony Health Solutions

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Subsys Increasing Market Penetration

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 MM1

Subsys Continues to Gain Market Share2

1 Twelve months ended 31 Dec 2013

2 Data as of April 2014 (Source: IMS Health)

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Subsys Efficacy Data – 5 Minute Onset of Pain Relief

Pivotal Efficacy Trial Results – Summed Pain Intensity Differences (SPID) Over Time

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, 859-870. *Primary endpoint p-value is derived from ANCOVA with a dependent variable of SPIDt 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

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

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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

14-25 min, buccal tablet

Dose Range 100g – 1,600g 200g – 1,600g 100g – 800g

Sugar Content None Yes None

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Subsys Has a Differentiated Product Profile

1 Statistically significant 2 Prescribing Information for Subsys, Actiq and Fentora

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U.S. Status (Approval Date)

Route of Administration

200 µg 400 µg 600 µg 800 µg 1,200 µg 1,600 µg

Marketed (1/4/2012) Sublingual Spray

Marketed (6/30/2011) Nasal Spray

Marketed (1/7/2011) Sublingual Tablet

Marketed (7/16/2009) Buccal Soluble Film

Marketed (9/25/2006) Buccal Tablet

Marketed (11/4/1998) Lozenge

Sources: Product labels and company websites Note: Check denotes doses for which each product is available

Actiq (Teva, multiple

generics)

Fentora (Teva)

Onsolis (BDSI/Meda)

Abstral (Galena)

Lazanda (Depomed)

100 µg

Subsys Offers Most Complete Range of Strengths

Brand (Company)

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R & D Pipeline: Sublingual Spray Technology

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Preclinical Phase 1 Phase 2 Phase 3 Phase 4

INDs targeted for 2H 2014

Buprenorphine (semi-synthetic opioid)

Buprenorphine/Naloxone (opioid antagonist)

Sildenafi l (API in Viagra)

Diclofenac (NSAID)

Ketorolac (NSAID)

Ondansetron (serotonin 5-HT3 receptor antagonist)

Sublingual Spray Platform

Dyspnea (incidental shortness of breath)

Pre-procedural use in a cl inical setting

ER situations: oncology

To manage pain in burn patients

Pediatric use

ER situations: acute pain

Label Expansion Opportunities

IND fi led

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Buprenorphine Buprenorphine/

Naloxone Ondansetron

Therapeutic Area Pain Opioid Addiction Nausea and

Vomiting

Market Size (US 2013)

$3.6B1 $1.7B2 $4.1B3

IND Filing4 2H 2014 2H 2014 2H 2014

1 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

R & D Pipeline: Sublingual Spray Technology

Page 13: InSys Therapeutics, Inc. - Jefferies · further develop its existing products and product candidates. For a further description of these and other risks facing Insys, please see the

Pharmaceutical Cannabinoids

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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 sales1

Growing despite generic competition, lack of promotion

Significant limitations:

Delayed absorption

Highly variable

Lack of flexibility in dosing

1 Source: IMS Health

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Insys received approval for generic dronabinol in August 2011 Launched Dronabinol SG Capsule in December 2011

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Insys Proprietary Dronabinol Product Franchise

Improved formulation provides opportunity to penetrate & expand dronabinol market

Lead program: Dronabinol Oral Solution

Clinically demonstrated advantages versus Marinol1

More rapid absorption

Less variability

Flexible dosing

Status

Pre-NDA discussion with the FDA

Pivotal bioequivalence clinical trial 2012

Clinical dossier complete Q3 2013

NDA submission expected in 2H 2014

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1 Clinical data from pivotal 52-patient crossover bioavailability and pharmacokinetics study completed in 2012

Page 16: InSys Therapeutics, Inc. - Jefferies · further develop its existing products and product candidates. For a further description of these and other risks facing Insys, please see the

Dronabinol Oral Solution Key Attributes

Source: 52-patient crossover study completed in 2012

Rapid Absorption

Less Dose-to-Dose Variability

Enables Flexibility in Dosing

Clinical Data from 52-Patient Crossover Bioavailability and PK Study

Subjects achieving detectable plasma levels at 15 minutes

Oral Solution: 100%

Marinol: <25%

Oral Solution reduced intra-patient variability by more than 60% (as measured by AUC)

Current formulations limited to 2.5mg, 5.0mg & 10.0mg capsules

0%

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Versatile Liquid Formulation

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AU

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R & D Pipeline: Pharmaceutical Cannabinoids

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Preclinical Phase 1 Phase 2 Phase 3 Phase 4

Dronabinol Oral Solution NDA submission planned by 2H

2014

One or more INDs targeted for 2H 2014

CBD: Addiction in cocaine, heroin & opioids

Pharmaceutical Cannabidiol (CBD): Epilepsy

CBD: Peripheral neuropathy in taxol-treated patients

CBD: Glioblastoma

Dronabinol

Pharmaceutical Cannabidiol

Page 18: InSys Therapeutics, Inc. - Jefferies · further develop its existing products and product candidates. For a further description of these and other risks facing Insys, please see the

R&D Pipeline: Pharmaceutical Cannabidiol (CBD)

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Pursuing four INDs with FDA for pharmaceutical CBD

Synthetically produced in a controlled environment – Received Drug Master File (DMF) #28255 from the FDA in Q2 2014

99%+ 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

Page 19: InSys Therapeutics, Inc. - Jefferies · further develop its existing products and product candidates. For a further description of these and other risks facing Insys, please see the

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 Market1

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

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

Page 20: InSys Therapeutics, Inc. - Jefferies · further develop its existing products and product candidates. For a further description of these and other risks facing Insys, please see the

Investment Highlights

19

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

Page 21: InSys Therapeutics, Inc. - Jefferies · further develop its existing products and product candidates. For a further description of these and other risks facing Insys, please see the