IntelGenX Investor Presentation March 30 2017

22
0 Investor Presentation March 30, 2017 Innovative Drug Delivery Solutions

Transcript of IntelGenX Investor Presentation March 30 2017

Page 1: IntelGenX Investor Presentation March 30 2017

0

Investor Presentation

March 30, 2017

Innovative Drug Delivery Solutions

Page 2: IntelGenX Investor Presentation March 30 2017

1

2

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

Forward Looking Statements

Page 3: IntelGenX Investor Presentation March 30 2017

2

2

3

• IntelGenx Corp. Founded• TSX-V (IGX)• OTCQX (IGXT)• Market Capitalization • Shares Issued• Shares Fully Diluted• Insider Ownership• Cash/Equivalent (As of Dec 31, 2016)

2003CAD$1.04

US$0.78CAD$68M

65.5M70.8M

15%CAD$6M

Analyst Coverage

Firm Analyst

H.C. Wainwright Swayampakula Ramakanth

Singular Research Greg Eisen

Company Snapshot

Page 4: IntelGenX Investor Presentation March 30 2017

3

4

Advantages of Oral Thin Film Delivery

We are focused on areas where oral films are particularly well-suited:

Develop and commercialize products that provide therapeutic advantages to patients

leveraging oral films, such as:

• Reduced side effects

• Improved bio-availability

• Response time versus existing drugs

• Lifecycle management

• Repurpose existing drugs for new indications using oral films

• “First-to-file” Generic drugs where high technology barriers to entry exist in reproducing branded films

Page 5: IntelGenX Investor Presentation March 30 2017

5

Clearly Defined BD StrategyBalancing Risks and Opportunities for an Optimized Portfolio

Overall

Risk

Time to MarketSlow Fast

Low

High

Drug Repurposing

Patient Benefits

Lifecycle Mgmt

FTF Generics

IntelGenx Future FocusDeal Value

Low

Medium

High

Page 6: IntelGenX Investor Presentation March 30 2017

5

A Robust Product Pipeline to Address Significant Market Opportunities

6

Page 7: IntelGenX Investor Presentation March 30 2017

6

7

• High dose version of Wellbutrin XL®

• Only approved, once-daily, bupropion HCl 450mg dose in a single tablet

• Launched commercially October 2013 in partnership with Edgemont Pharmaceuticals

• Sold US revenue to SWK Holdings for US$6M

• Development cost $2.5M, total revenue $15M = 6-fold ROI

• Non-dilutive source of funding, will be used to advance film projects

Successful Monetization of First In-House Development

Page 8: IntelGenX Investor Presentation March 30 2017

7

8

• Licensing and development agreements entered for four generic products

• IntelGenx granted Chemo exclusive worldwide license to commercialize two generic tablets and U.S. license for two other generic oral films

• IntelGenx to receive upfront, milestone, R&D revenues and share of profits – total value of 7 digits

• Combined total market of four products is over $7B

• Chemo making a strategic move into novel drug delivery products with IntelGenx as its partner

• Partnership could result in numerous future product agreements

Strategic Partnership with Chemo Group

About Chemo Group:

• Founded in 1978

• 5,000 employees

• Head office in Spain

• Revenues of $1.2B annually

• Markets over 300 products

• Operating in over 40 countries

• 20 state-of-the-art facilities

• 9 specialized R&D centers

Page 9: IntelGenX Investor Presentation March 30 2017

8

For Migraines

Leverages VersaFilm™ Technology

9

• European Mktg Approval – November 2015

• Co-development partnership with RedHill Biopharma

• Definitive agreement signed July 2016 with

Grupo Juste for Spain & additional territories

• Definitive agreement signed Dec 2016 with Pharmatronic

for South Korea

• Actively pursuing several opportunities to open new

markets - negotiations with future commercialization

partners ongoing

• Planned USA submission to FDA Q3 2017

• Expected USA approval Q1 2018

Page 10: IntelGenX Investor Presentation March 30 2017

9

For Erectile Dysfunction

• Accelerates our partnering of this product for commercializing Tadalafil in the U.S.

• Containing tadalafil (Cialis® - Eli Lilly), a leading molecule in the ED market

• Demonstrated bioequivalence to Cialis®

• Orally disintegrating films without need for water provide unprecedented patient convenience and a discrete dosing alternative

• 505(b)(2) USA NDA submission in Q2 2017

• Expected USA approval H1/2018

10

IntelGenx secured exclusive license for oral film from Lilly for Tadalfil ED dosing patent ‘166

Page 11: IntelGenX Investor Presentation March 30 2017

10

For Schizophrenia & Bipolar 1 Disorder

11

• The first oral thin film using IntelGenxproprietary drug delivery technology, VersaFilm™, for treatment of schizophrenia & bipolar 1 disorder

• Fast-acting loxapine oral dosage – to treat acute agitation and anxiety in non-institutionalized patients with schizophrenia & bipolar 1 disorder

• Reduces risk of pulmonary problems and potential risk of violence and injury to patients and others

• Formulation optimization stage – results expected H2 2017

Page 12: IntelGenX Investor Presentation March 30 2017

11

For Mild Cognitive Impairment

12

• IntelGenx is repurposing Montelukastfor the treatment of MCI by leveraging its VersaFilm™ technology

• The drug is known and approved for a completely different indication (asthma)

Global Sales for AD by Patients Category (Global

Data, 2013)

Page 13: IntelGenX Investor Presentation March 30 2017

12

2

13

Clinical Data

0.0

100.0

200.0

300.0

400.0

500.0

600.0

0.00 5.00 10.00 15.00 20.00 25.00 30.00Monte

lukast

concentr

ation (

ng/m

L)

Time (hrs)

Montelukast Avg Plasma Profile

Test buccal film 10mg

Ref tablet 10mg

• Phase 1 clinical study in human successfully completed

• Significantly increased bioavailability after administration of VersaFilm compared to

commercial tablet

• Drug crosses blood/brain barrier when given as film

• Phase II-a study (proof of concept) to commence Q1/2017

• First efficacy data in humans available Q4/2017

• Several Pharma companies have expressed strong interest

Before

MMSE 13:

moderate to severe

dementia

MMSE 22:

mild dementia

After 2 Months of

Montelukast

Page 14: IntelGenX Investor Presentation March 30 2017

13

14

Construction of Manufacturing Facility Completed

• 17,000 sq ft facility in Montreal -construction completed in Q1 2016

• Facility to be fully operational by Q1 2017

• High capacity manufacturing and packaging equipment

• Lower costs, controls quality and de-risks investment for new products

GROSS MARGINS of 40% PLUS

We have built a state-of-the-art oral film development and manufacturing facility

Page 15: IntelGenX Investor Presentation March 30 2017

14

Strengthened Management TeamOver 20 Employees, including 7 with Ph.D.’s

Andre Godin, CPA, CA

Executive VP, CFO

• 25+ years biotech/pharma industry experience

• Member of the Canadian Chartered Professional Accountants and the Canadian Institute of Chartered Accountants

Nadine Paiement, M. Sc.

VP, Research & Development

• Co-inventor of IntelGenx Trilayer Technology

• 15 years experience in product development and technology transfer

Stephen KilmerInvestor Relations

• President of Kilmer Lucas, a health-care only investor relations and capital markets advisory company

Horst G. Zerbe, Ph. D.

Chairman, President & CEO

• Co-Founder of Listerine breath strips

• 30+ years drug delivery / pharma experience

• Holds over 40 patents in drug delivery and numerous scientific publications

15

Dana Matzen, Ph.D.

VP, Business & Corporate Development

• 15 years experience in pharmaceutical product licensing

• Prev. Director, BD at Paladin • Completed 13 transaction,

7 new product launches

John Durham, B. Sc.

VP, Operations

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

• Held executive positions with several Canadian and US companies

Page 16: IntelGenX Investor Presentation March 30 2017

15

16

The IntelGenx Advantage

1. History

• Dr. Zerbe a pioneer with over 30 plus years in oral films

2. Formulation Team

• Strong in applying biopharmaceutical aspects to formulation development

• Top quality scientists: highly creative, focused on problem solving & innovative approaches

• Experienced in developing films for oral (GI), sublingual & buccal absorption

3. Clearly Defined Corporate Strategy And Business Model

• Focus on drug repurposing, lifecycle management, patient benefits, and FTF

• Provider of comprehensive pharmaceutical services to industry partners

4. Competitive Manufacturing Capabilities

• First in Canada

• New state-of-the-art manufacturing facility

• Offer one-stop-shopping to our partners with lean operations keeping costs down

• Customized manufacturing equipment

Page 17: IntelGenX Investor Presentation March 30 2017

16

Financial Results

17

Page 18: IntelGenX Investor Presentation March 30 2017

17

Financial Performance

Revenue ($M)

5.2 5.1

1.7

0

1

2

3

4

5

6

2016 Full Year 2015 Full Year 2014 Full Year

Revenue

$M

18

Page 19: IntelGenX Investor Presentation March 30 2017

18

Net Comprehensive Income & Adjusted EBITDA ($M)

-1.5

0.8

-2.2

-0.3

1.7

-1.6

-2.5

-2

-1.5

-1

-0.5

0

0.5

1

1.5

2

2016 Full Year 2015 Full Year 2014 Full Year

Net Income Adjusted EBITDA

$M

Financial Performance

19

Page 20: IntelGenX Investor Presentation March 30 2017

19

Conclusion

20

Page 21: IntelGenX Investor Presentation March 30 2017

20

21

Solid Platform for Growth

Significant Market Potential

• New manufacturing facility will offer many competitive advantages

• Strengthened management team to accelerate execution of business plan

• Implemented product sourcing strategy to identify high-value product opportunities

• Building strategic partnerships with relevant partners in the pharmaceutical industry

Solid Platform for Growth

Page 22: IntelGenX Investor Presentation March 30 2017

21

22

Thank You!www.IntelGenx.com

Contact Info:Stephen Kilmer André Godin Investor Relations Executive VP & CFO+1-514-331-7440 ext. 232 +1-514-331-7440 ext. [email protected] [email protected]

IntelGenx Corporate Offices6420 AbramsSaint-Laurent (Quebec)H4S 1Y2 Canadawww.intelgenx.com