intelgenx corporate presentation

23
Innovation In Drug Delivery An introduction to unique pharmaceutical delivery technologies May 2015 TSX-V: IGX OTCQX: IGXT

Upload: viral-network-inc

Post on 25-May-2015

388 views

Category:

Health & Medicine


0 download

DESCRIPTION

IGXT Corporate Presentation.

TRANSCRIPT

Page 1: IntelGenx Corporate Presentation

Innovation In Drug DeliveryAn introduction to unique pharmaceutical delivery technologies

May 2015

TSX-V: IGX OTCQX: IGXT

Page 2: IntelGenx Corporate Presentation

FORWARD LOOKING STATEMENTS

To the extent any statements made in this presentation contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as "believe," "anticipate," "expect," "intend," "plan," "will," "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Forward-looking statements include, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting U.S. Food and Drug Administration and Canadian Therapeutic Products Directorate approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials and finished products, the regulatory environment, tax rate assumptions, the outcome of legal proceedings, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission and the Ontario Securities Commission. IntelGenx undertakes no obligation to update or revise any forward-looking statement.

2

Page 3: IntelGenx Corporate Presentation

Rapid and convenient dosage form for more immediate activity

Programmable drug release over an extended period of time

Controlled absorption in the oral cavity to maximize bioavailability

INTELGENX DEVELOPS FASTER AND MORE EFFICIENT DRUG DELIVERY SYSTEMS FOR TOP PHARMACEUTICALS

INNOVATIVE DELIVERY TECHNOLOGY

VERSATAB™ ADVERSA™VERSAFILM™

FOCUSING ON ORAL DRUG DELIVERY

3

Page 4: IntelGenx Corporate Presentation

UNIQUE TECHNOLOGIES

TECHNOLOGY FOCUSED

Develop novel and high performance drug delivery systems – focus on oral film products.

TARGET HIGH-VALUE DIFFERENTIATED OPPORTUNITIES

INNOVATIVE DELIVERY TECHNOLOGY

• Use proprietary drug delivery technologies to develop products offering a therapeutic benefit to patients.

• Identify unique drug-repurposing opportunities.• Pursue high technological entry barrier products and first-to-file

opportunities.• Develop products addressing unmet therapeutic needs.

4

Page 5: IntelGenx Corporate Presentation

PROVIDE COMPREHENSIVE PHARMACEUTICAL SERVICES TO INDUSTRY PARTNERS:

Pharmaceutical Research and Development Clinical monitoring; clinical supply manufacturing Regulatory services Process development and technology transfer

Commercial product supply

REVENUE STREAM CONSISTING OF: Upfront payments R&D milestone payments Sales milestone payments Royalties on sales Manufacturing revenue

VALUE PROPOSITION

5

Page 6: IntelGenx Corporate Presentation

PRODUCT PORTFOLIOA ROBUST PRODUCT PIPELINE ACROSS 3 TECHNOLOGY PLATFORMS

PRECLINICAL PILOT STUDY PIVOTAL STUDY FILING LAUNCH

Forfivo XL® Major Depressive Disorder

INT0001 Hypertension

INT0024 Idiopathic Pulmonary Fibrosis (Pacific)

INT0008 Migraine (RedHill)

INT0027 Opioid Dependence (Par)

INT0037 Undisclosed (Par)

INT0039 Undisclosed (Par)

INT0007 Erectile Dysfunction

INT0036 Central Nervous System (CNS)

INT0010 Pain

Launched Q4 2012

Q1 2013

Q3 2013

Ver

saTa

bTM

Ver

saF

ilmT

MA

dVer

saT

M

Page 7: IntelGenx Corporate Presentation

INTELGENX PARTNERSHIPSINTELGENX HAS STRATEGIC PARTNERSHIPS IN PLACE WITH MULTIPLE COMPANIES

7

Page 8: IntelGenx Corporate Presentation

VersaTabTM

Addressable market for pipeline VersaTabTM products.

VersaFilmTM

Opportunity to convert existing tablet market into film technology

$8.1 Billion

$2.7 Billion

ADDRESSABLE MARKET FOR PRODUCT PIPELINE

SIGNIFICANT MARKET POTENTIAL

~$11BCombined,

addressable market for

product pipeline

25%

75%

$11b Total addressable

market

Page 9: IntelGenx Corporate Presentation

$1.2B

2013 MetroprololSales

$1.1B

Pentoxifylline - NAC

• Linear release profile; controlled erosion of inactive cover layers

• Multiple actives with independent release profiles

• Separation of active ingredients - avoidance of chemical incompatibility in fixed-dose combinations

• Cost-effective manufacturing

Depression Hypertension

Idiopathic Pulmonary Fibrosis Addressable

Market

$391M

Wellbutrin XL & Bupropion XL Sales

PRECLINICAL PILOT STUDY PIVOTAL STUDY FILING LAUNCH

Forfivo XLMajor

Depressive Disorder

INT0001 Hypertension

INT0024

Idiopathic Pulmonary

Fibrosis (Pacific)

VERSATAB®

PRODUCTS

Launched Q4 2012®

VersaTab® Addressable Market

~$2.7B

MULTILAYER TABLET TECHNOLOGY

VERSATAB TM

9

Page 10: IntelGenx Corporate Presentation

$3.0B

Current Market for Bupropion

• High dose version of Wellbutrin XL®

• Provides a once-daily, bupropion 450 mg dose in a single tablet

• Indicated for the treatment of major depressive disorder

• Launched commercially October 2012 in partnership with Edgemont Pharmaceuticals

• Paragraph IV litigation with with Wockhardt settled

$236M

Wellbutrin XL®Market

$2.7M

2013 SalesForfivo XL

FORFIVO XL® SCRIPT GROWTH

®

VERSATAB TM

VersaTab®

Addressable Market

~$2.7B

FORFIVO XL® COMMERCIALIZATION GROWTH OPPORTUNITY

10

10/31/12

12/31/12

2/28/13

4/30/13

6/28/13

8/30/13

10/31/13

12/31/13

2/28/14

4/30/14

6/30/14

8/29/14

10/31/14

12/31/14

2/28/150

1,000

2,000

3,000

4,000

5,000

$0

$300,000

$600,000

$900,000

$1,200,000

$1,500,000

$1,800,000

Over $1.5M

March 2015Gross Sales

3,893March 2015

Prescriptions

Page 11: IntelGenx Corporate Presentation

VersaFilm™ Rapidly disintegrating pharmaceutical films for buccal or systemic drug delivery

VersaFilm Addressable Market

~$8.1B

®

Improved product performance:• Fast delivery translates into

rapid onset of action• Improved bioavailability• Buccal (topical) or systemic

drug exposure

Improved patient compliance:• Convenient delivery

improving compliance for pediatric and geriatric patients where swallowing is an issue

Increased barrier for generic competition:• Limited number of

competitors

ADVANTAGES OF FILM TECHNOLOGY

VERSAFILM TM

11

Page 12: IntelGenx Corporate Presentation

$1.3B

• Demonstrated ability to achieve bioequivalence

• Two applications currently under review at FDA: one ANDA, and one 505(b)(2)NDA

• Comprehensive VersaFilm™ development pipeline

• Limited number of

competitors, strong IP position

Opioid Dependence Migraine Erectile Dysfunction

$230M

Targeted Rizatriptan Market

Targeted Cialis Sales

®

$1.6B

Targeted Suboxone Sales

®

VersaFilm Addressable Market

~$8.1B

®

ADDRESSABLE MARKETS

VERSAFILM TM

12

PRECLINICAL

PILOT STUDY

PIVOTAL STUDY

FILING LAUNCH

INT0008 Migraine (RedHill)

INT0027

Opioid Dependence (Par)

INT0007 Erectile Dysfunction

INT0036 CNS

INT0037 Undisclosed (Par)

INT0039 Undisclosed (Par)

Q1 2013 2015

VERSAFILMPRODUCTS

Q3 2013 2017

Q4 2016 Q4 2017

horst zerbe
make chart consistent with pipeline chart
Page 13: IntelGenx Corporate Presentation

Suboxone® Rx Quantities (Millions)

2008 2009 2010 2011 2012 20130

20

40

60

80

Film Tablet• Demonstrated ability to

achieve bioequivalence

• Two applications currently under review at FDA: one ANDA, and one 505(b)(2)NDA

• Comprehensive VersaFilm™ development pipeline

• Limited number of

competitors, strong IP position

VersaFilm Addressable Market

~$8.1B

®

ATTRACTIVE LIFECYCLE MANAGEMENT OPPORTUNITY

VERSAFILM TM

13

Su

boxo

ne

®

Su

blin

gual Fi

lm

Su

boxo

ne

®

Su

blin

gual Ta

ble

ts

Page 14: IntelGenx Corporate Presentation

0 12 24 36 48 60 720

0.35

0.7

1.05

1.4

Buprenorphine plasma profile

Test product Test product

Time (hrs)

Mea

n co

ncen

trati

on (n

g/m

L) Reference product

Suboxone Addressable Market

~$1.6B

®

Completed development with successful pivotal bioequivalency study.

Abbreviated New Drug Application (ANDA) submitted to FDA in July 2013.

Marketing approval anticipated 2016.

Attractive partnership deal with Par Pharmaceutical

P4 litigation with Reckitt Benckiser progressing well

0 6 12 18 240

30

60

90

120

150

Naloxone plasma profile

Test product reference product (Suboxone 8/2mg)

Time (hrs)

Mea

n co

ncen

trati

on (p

g/m

L)

OPIOD DEPENDENCE - BUPRENORPHINE/NALOXONE

VERSAFILM TM

14

Page 15: IntelGenx Corporate Presentation

Rizatriptan® Addressable Market

$230M

Successfully completed development and stability testing

Filed 505(b)(2)NDA in March 2013

Co-development and licensing agreement in place with RedHill Biopharma

Negotiations with commercialization partner ongoing

0.0 3.0 6.0 9.0 12.0 15.00.0

4.5

9.0

13.5

18.0

Time (hrs)

Riza

trip

tan

Pl. C

onc.

(ng/

mL)

VersaFilm Rizatriptan

Maxalt MLT®

Orally disintegrating film containing Rizatriptan bioequivalent with orally disintegrating tablet (Maxalt

MLT®)

MIGRAINE FILM BIOEQUIVALENT TO MAXALT MLT®

VERSAFILM TM

15

Page 16: IntelGenx Corporate Presentation

Cialis® Addressable Market

~$1.3B

CP pending for OTC approval

Formulation development ongoing.

Worldwide patent application.

Pilot BE study on 10 mg strength suggests BE with RLD.

Confirmatory pilot BE study on 20 mg strength completed.

Successful pilot BE study (10 mg strength)

BIOEQUIVALENCE ACHIEVED VS. CIALIS® TABLETS

VERSAFILM TM

16

Page 17: IntelGenx Corporate Presentation

Schizophrenia Market1~$5.2B

CNS FILM INT0036 – A fast acting version of an existing schizophrenia treatment.

VERSAFILM TM

Successfully completed pilot scale Phase I study

INT0036 demonstrated a significantly improved pharmacokinetic profile against the reference product

1 According to Datamonitor Healthcare schizophrenia forecast published July 13, 2012

0 15 30 45 600

7,500

15,000

22,500

Time (min)

Riz

atr

ipta

n P

l. C

onc.

(ng/m

L)

VersaFilm INT0036

RLD

Page 18: IntelGenx Corporate Presentation

A STRONG PLATFORM FOR GROWTH AND INNOVATION

VERSAFILM TM

• Addressable market of approximately $8.1 billion identified to-

date

• Strong intellectual property protection

• Successful pivotal bioequivalency studies

• Three applications for film products awaiting FDA approval

• Limited number of competitors

• Life cycle management opportunity

Page 19: IntelGenx Corporate Presentation

DEVELOPING FILM MANUFACTURING CAPABILITIES TO INCREASE PROFITABILITY

OPERATIONAL INITIATIVES

19

• Significantly increase IntelGenx' revenue stream

• Improve protection of IntelGenx' IP.

• Eliminate dependency on 3rd party manufacturing partners

• Provide full service from inception to product supply (one-stop-

shopping).

• Increase R&D capabilities and investments with expanded

laboratories and technologies.

Page 20: IntelGenx Corporate Presentation

Develop

• 2014, Identify a second supplier for Rizatriptan

• 2014, Submit application for Rizatriptan in Europe

• 2014, Acceptance of ANDA for INT0027 triggering a milestone payment from Par

• 2014, Clarity on ForFivo XL litigation with WockHardt

2014 2015 2016 2017

SUGGESTS NEAR TERM CATALYSTS

KEY MILESTONES

Position

• 2015, Anticipated approval for migraine VersaFilmTM

• 2015, Anticipated submission of ANDA for Antihypertensive VersaTabTM

• 2016, Anticipated tentative approval for opioid dependence VersaFilm™

• 2016, Commence manufacturing capabilities of VersaFilm™

Grow

• 2016, Anticipated submission of 505(b)(2) NDA for ED VersaFilm™

• 2017, Anticipated launch for opioid dependence VersaFilm™

• 2017, Anticipated approval for ED VersaFilm™

20

Page 21: IntelGenx Corporate Presentation

Horst G. Zerbe, Ph.D.Chairman, President and CEO

• Founder of IntelGenx• 30+ years Industry Experience• Holds over 40 patents in drug delivery, and numerous

scientific publications• Previously President Smartrix Tech. Inc. and VP R&D at

LTS Lohmann, USA

Paul Simmons, AFCAChief Financial Officer

Nadine Paiement, M.Sc.Director R&D

• 25 + years multinational business and finance experience• Proven track record of exceeding targets in delivering

corporate growth• Held CFO and VP Finance positions with several European

corporations

• Co-inventor of IntelGenx Trilayer Technology• 10 years experience in product development and

technology transfer• Previously R&D Manager at Smartrix Tech. Inc.

65+ YEARS OF COMBINED INDUSTRY EXPERIENCE

VISIONARY, EXPERIENCED LEADERSHIP

21

John Durham, B.Sc.Vice President, Manufacturing Operations

• 20+ years experience in pharmaceutical manufacturing, quality management, product development

• Held executive positions with several Canadian and US companies

• Previously COO at Labopharm Inc. and President at Draxis Pharma

Page 22: IntelGenx Corporate Presentation

CORE TECHNOLOGIES ADDRESS LARGE MARKET POTENTIAL

A SOLID PLATFORM FOR GROWTH

• Continue to expand commercialization efforts of Forfivo XL® and drive revenue growth

• Advance pipeline products towards commercialization

• Continue to develop commercialization relationships

• Leverage VersaFilm™ manufacturing expertise to provide full service

VERSATAB™ ADVERSA™VERSAFILM™

22

Page 23: IntelGenx Corporate Presentation

Innovation In Drug DeliveryThank You

TSX-V: IGX OTCQX: IGXT