igxt sep 21 investor presentation
TRANSCRIPT
0
Investor Presentation
September 21, 2016
Innovative Drug Delivery Solutions
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
2
2
3
• IntelGenx Corp. Founded• TSX-V (IGX)• OTCQX (IGXT)• Market Capitalization • Shares Issued• Shares Fully Diluted• Insider Ownership• Cash/Equivalent
2003CAD$1.10
US$0.81US$52M
64.7M70.8M
15%US$6M
Analyst Coverage
Firm Analyst
H.C. Wainwright Swayampakula Ramakanth
Singular Research Greg Eisen
Company Snapshot
3
2
4
Oral Thin Films
Oral Thin Films Provide
Significant Market Opportunities
for Improving Drug Delivery
• IntelGenx CEO co-developer of the
Listerine breath strips
• Oral films provide quicker action to relieve
symptoms
• IntelGenx’s goal to become a leader in
pharmaceutical oral film development &
manufacturing
4
5
Clearly Defined BD Strategy
We are focused on areas where oral films
are particularly well-suited:
Develop and commercialize products that provide tangible patient benefits
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
5
A Robust Product Pipeline to Address Significant Market Opportunities
6
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
7
8
For Migraines
Leverages VersaFilm™ Technology
• European Mktg Approval – November 2015
• Co-development partnership with RedHill Biopharma
• Definitive agreement signed July 2016 with
Grupo Juste for Spain & additional territories
• Term sheet signed September 21, 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 Q1/2017
• Expected USA launch Q3/2017
8
For Erectile Dysfunction
• 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
Q1/2017
• Expected USA launch Q1/2018
9
9
For Schizophrenia & Bipolar 1 Disorder
10
• The first oral thin film using IntelGenx
proprietary 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 Q2 2017
10
Mild Cognitive Impairment
(MCI)
> 80 Mi persons
Dementia
> 30 Mi persons
Brain Degenerative DiseasesSizeable Addressable Patient Population
5
Dementia> X patients WW
Currently approved treatments for brain degenerative diseases are limited,
resulting in unmet clinical needs, which translates into a promising market
opportunity11
Alzheimer’s Disease
(AD)1 Mild > 6.5 Mi persons2 Moderate > 3.9 Mi persons3 Severe > 2.1 Mi persons
Cognitive Disorder Stage and Prevalent Population(Global Data, 2013 )
Neurodegenerative Clinical Changes(Global Data, 2013)
Issues with word selection
Misplacing of belongings
Iinability to recall recent events
Memory loss
Cognitive impairment
Functional decline
Drastic reduction in quality of life
Requires full-time support
1 Mood and personality changes
Poor judgment
Frequently getting lost
2 Difficulty recognizing family or friends
Inability to learn new concepts
Hallucinations, delusions, or paranoia
3 Inability to communicate
Poor swallowing function
Incontinence
Global Sales for AD by Patients
Category (Global Data, 2013)
11
12
A De-Risked Product CandidateFor the Treatment of Brain Degenerative Diseases
IntelGenx is developing montelukast VersaFilm™, the first oral
thin film containing montelukast for the treatment of brain
degenerative diseases
Already Approved and Established Drug Molecule
Supporting Epidemiology Data
Strong Preclinical Evidence
IP Strategy
UNIQUE DRUG
REPURPOSING
OPPORTUNITY FOR
BRAIN DEGENERATIVE
DISEASES
Supporting Ph1 Data
12
Montelukast Improves Cognitive FunctionsIn Animal Models of Brain Degenerative Diseases
13
Montelukast treatment improves learning and memory in the Morris water maze test
(c)
After learningBefore learning
Hidden platform
Wading pool
Figure 1: Montelukast treatment improves learning and memory in
an animal model of mild cognitive impairment. Young (4 mo old)
and old (20 mo old) Fisher 344 rats were orally administered 10
mg/kg body weight of montelukast for 42 d. On days 35 to 41, the
Morris water test was conducted to assess the ability of spatial
learning and memory. Zone P is a defined circular area with 20 cm
diameter enclosing the former platform location. (a) Representative
tracks of the distances moved in the Morris water maze before and
after learning. (b) Time in platform quadrant (s). (c) Time in zone P
(s). (d) Number of entries in zone P. mtk, montelukast; veh, vehicle;
yg, young. * p<0.05. (Marschallinger et al., Nature Comm, 2015)
(a)
(b) (c) (d)
Similar data in an animal model of Lewy Body Dementia (Aigner, Unpublished Data)
13
2
14
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
• First clinical study successfully completed
• Significantly increased bioavailability after administration of VersaFilm compared to
commercial tablet
• Drug crosses blood/brain barrier when given as film – patent application pending
• 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
14
• Licensing and development agreement entered
September 12, 2016 for three generic products
• IntelGenx granted Chemo exclusive worldwide license
to commercialize one generic product and U.S.
license for two other generic products
• IntelGenx to receive upfront, milestone, R&D
revenues and share of profits – total value of 7 digits
• Combined total market of three products is over $3B
• 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
15
15
16
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
16
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
Edward Miller, B. Comm
Director, Investor Relations
• 15 years experience in
investor relations
• 10 + years experience in
pharmaceutical / biotech
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
17
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
17
18
What Makes IntelGenx the Best in Oral Films
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
18
Financial Performance
Revenue ($M)
1.51.2
5.1
1.7
0
1
2
3
4
5
6
H1 2016 H1 2015 2015 Full Year 2014 Full Year
Revenue
$M
19
19
Net Comprehensive Income & Adjusted EBITDA ($M)
-1.5
-0.6
0.8
-2.2
-1.2
-0.1
1.7
-1.6
-2.5
-2
-1.5
-1
-0.5
0
0.5
1
1.5
2
H1 2016 H1 2015 2015 Full Year 2014 Full Year
Net Income Adjusted EBITDA
$M
Financial Performance
20
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
21
22
Thank You!www.IntelGenx.com
Contact Info:Edward Miller, B.Comm.Director, Investor Relations+1-514-331-7440 ext. [email protected]
IntelGenx Corporate Offices6420 AbramsSaint-Laurent (Quebec)H4S 1Y2 Canadawww.intelgenx.com