intelgenx q4 earnings presentation
TRANSCRIPT
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Conference Call & Webcast
March 23, 2016
Q4 & Full Year 2015 Financial Results
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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.
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Forward Looking Statements
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WelcomeHorst G. Zerbe, Ph. D.
Chairman, President & CEO
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IndicationPartnering
Availability
Formulation
Development
Pilot
StudyPivotal Study Filing Launch
Films Migraine – Rizaport TM - Rizatriptan Available
Erectile Dysfunction - Tadalafil Available
Opioid Dependence Par
Pharmaceuticals
Schizophrenia - Loxapine Available
Undisclosed Available
Pain Available
Central Nervous System Available
Central Nervous System Available
Respiratory Available
Cardiovascular Available
Tablets Major Depressive Disorder –
Forfivo XL®
Bupropion
Edgemont
Pharmaceuticals
Available ex-USA
Hypertension - Metoprolol Available
Pain - Dronabinol Available
A Robust Product Pipeline to AddressSignificant Market Opportunities
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Forfivo XL
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• 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
• Q4 2015 net sales grew 24% compared
to Q3 2015, with net sales at $3 million
($5.4 million gross)
• For the past twelve months, net sales
totaled $9.3 million ($17.4 million gross),
an increase of 102% compared to the
twelve month period in 2014
First 450mg tablet approved by FDA for major depressive disorder
1697 1756
2108
2447
3022
$0.00
$500.00
$1,000.00
$1,500.00
$2,000.00
$2,500.00
$3,000.00
$3,500.00
4Q14 1Q15 2Q15 3Q15 4Q15
Forfivo XL Net Sales ($,000s)
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Rizaport™
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For Migraines
Leverages VersaFilm™ Technology
• European Mktg Approval – November 2015
• Filed 505(b)(2) NDA - March 2013 for USA
• Co-development partnership with
RedHill Biopharma
• Negotiations with commercialization
partner ongoing
• Patent granted in Feb 2016 protecting
Rizaport
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Leverages VersaFilm™ Technology
Par Projects
• Par Pharmaceuticals acquired by Endo Pharmaceuticals – Sept 2015
• Par has now returned two of three projects back to IntelGenx
• Par & IntelGenx now focused on Opioid Dependence Product
• Opioid Dependence product under review at FDA since July 2013
• Reckitt Benckiser vs. Par: Hatch/Waxman: court decision by May 1st,
2016
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For Erectile Dysfunction
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• The first oral thin film using IntelGenx
proprietary drug delivery technology,
VersaFilm™, for ED
• Containing tadalafil (Cialis® - Eli Lilly),
a major 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
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For Schizophrenia & Bipolar 1 Disorder
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• The first oral thin film using IntelGenx
proprietary drug delivery technology,
VersaFilm™, for Schizophrenia & Bipolar
1 disorder
• Fast-acting loxapine oral dosage – to
treat acute agitation with Schizophrenia &
Bipolar 1 disorder in non-institutionalized
patients
• Reduces risk of pulmonary problems and
potential risk of violence and injury to
patients and others
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Strategy Update
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Horst G. Zerbe, Ph. D.Chairman, President & CEO
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Strengthened Management TeamCurrently 21 Employees, 9 Ph.D.’s
André 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
Robert Bechard, M. Sc.
VP, Corporate Development
• 20+ years experience in
biopharmaceutical and
venture capital
• Managing Partner of
Lifescience venture fund at
RBC Capital
• Director on 25 lifescience
boards
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
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Dana Matzen, Ph.D.
VP, Business Development
• 15 years experience in
pharmaceutical product
licensing
• Former Director, BD at
Paladin Labs
• 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
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Completion of Constructionof Manufacturing Facility
• 17,000 sq ft facility to be officially
commissioned in mid-2016
• High capacity manufacturing and
packaging equipment
• Lower costs, controls quality
and de-risks investment
for new products
We have built a state-of-the-art
oral film development and manufacturing facility
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Patents Coming Off Protection
Many patient applications are compatible
with oral film characteristics
• Those who have difficult swallowing large pills: pediatric, geriatric, or dysphagic
• North Americans over 65 will grow from 54MM to 85MM over the next 15 years
• Patients who suffer gastrointestinal side effects from their medication
• Normal patients who would prefer a more discrete or pleasant administration of the drug
Large numbers of
well-known drugs
are coming off
patent protection
in the next few years
• Sources: FDA “orange book” data; Larson & Co analysis
10041139 1196
979880
2016 2017 2018 2019 2020
Number of FDA patent expiries by year2016-2020
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We are Now Poised for Success
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
or response time versus existing drugs
• First-to-file generic drug where high technology barriers to entry
exist in reproducing branded films
• Repurpose existing drugs for new indications using oral films
• Lifecycle management
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Q4 & 2015 Full-Year
Financial ResultsAndré Godin, CPA, CA
Executive VP, CFO
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Record Results in 2015 Demonstrates Strong Execution of Strategy
Revenue ($M)
1.5
0.83
5.1
1.7
0
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Q4 2015 Q4 2014 2015 Full Year 2014 Full Year
Revenue
$M
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Forfivo XL
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• Q4 2015 net sales grew 24% compared
to Q3 2015, with net sales at $3 million
($5.4 million gross)
• For the past twelve months, net sales
totaled $9.3 million ($17.4 million gross),
an increase of 102% compared
to the twelve month period in 2014
First 450mg tablet approved by FDA for major depressive disorder
1697 1756
2108
2447
3022
$0.00
$500.00
$1,000.00
$1,500.00
$2,000.00
$2,500.00
$3,000.00
$3,500.00
4Q14 1Q15 2Q15 3Q15 4Q15
Forfivo XL Net Sales ($,000s)
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Forfivo XL - Strong Growth
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• 4Q15 Trxs increased 42% vs. 4Q14 and 8% vs. 3Q15
• 4Q15 Net Sales nearly doubled vs. 4Q14 and increased 24% vs. 3Q15
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Net Comprehensive Income & Adjusted EBITDA ($M)
0.23
-0.33
0.8
-2.2
0.43
-0.23
1.7
-1.6
-2.5
-2
-1.5
-1
-0.5
0
0.5
1
1.5
2
Q4 2015 Q4 2014 2015 Full Year 2014 Full Year
Net Income Adjusted EBITDA
$M
Record Results in 2015 Demonstrates Strong Execution of Strategy
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ConclusionHorst G. Zerbe, Ph. D.
Chairman, President & CEO
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Solid Platform for Growth
Significant Market Potential
• Continue to grow commercialization efforts of Forfivo XL® to drive revenue growth
• 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
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Invitation – Grand Opening – May 10th
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Questions?
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Thank You
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