Cautionary Statement Regarding Forward-Looking
Information
Certain statements in this document constitute
“forward-looking statements” within the meaning of the
United States Private Securities Litigation Reform Act of 1995
and/or “forward-looking information” under the
Securities Act (Ontario). These statements include, without
limitation, statements expressed or implied regarding our
expectations regarding our plans, goals and milestones, status of
developments or expenditures relating to our business, plans to
fund our current activities, and statements concerning our
partnering activities, health regulatory submissions, strategy,
future operations, future financial position, future sales,
revenues and profitability, projected costs and market penetration.
In some cases, you can identify forward-looking statements by
terminology such as “appear”, “unlikely”,
“target”, "may", "will", "should", "expects", "plans",
"plans to", "anticipates", "believes", "estimates", "predicts",
"confident", "prospects", "potential", "continue", "intends", "look
forward", "could", “would”, “projected”,
“goals” ,“set to”, “seeking” or
the negative of such terms or other comparable terminology. We made
a number of assumptions in the preparation of our forward-looking
statements. You should not place undue reliance on our
forward-looking statements, which are subject to a multitude of
known and unknown risks and uncertainties that could cause actual
results, future circumstances or events to differ materially from
those stated in or implied by the forward-looking statements.
Risks, uncertainties and other factors that could affect our actual
results include, but are not limited to, the effects of general
economic conditions, securing and maintaining corporate alliances,
our estimates regarding our capital requirements, and the effect of
capital market conditions and other factors, including the current
status of our product development programs, on capital
availability, the estimated proceeds (and the expected use of any
proceeds) we may receive from any offering of our securities, the
potential dilutive effects of any future financing, potential
liability from and costs of defending pending or future litigation,
our ability to realize any benefits from our recent reverse stock
split and our ability to comply with the Nasdaq and TSX continued
listing standards, our programs regarding research, development and
commercialization of our product candidates, the timing of such
programs, the timing, costs and uncertainties regarding obtaining
regulatory approvals to market our product candidates and the
difficulty in predicting the timing and results of any product
launches, the timing and amount of profit-share payments from our
commercial partners, and the timing and amount of any available
investment tax credits, the actual or perceived benefits to users
of our drug delivery technologies, products and product candidates
as compared to others, our ability to establish and maintain valid
and enforceable intellectual property rights in our drug delivery
technologies, products and product candidates, the scope of
protection provided by intellectual property rights for our drug
delivery technologies, products and product candidates, recent and
future legal developments in the United States and elsewhere that
could make it more difficult and costly for us to obtain regulatory
approvals for our product candidates and negatively affect the
prices we may charge, increased public awareness and government
scrutiny of the problems associated with the potential for abuse of
opioid based medications, pursuing growth through international
operations could strain our resources, our limited manufacturing,
sales, marketing or distribution capability and our reliance on
third parties for such, the actual size of the potential markets
for any of our products and product candidates compared to our
market estimates, our selection and licensing of products and
product candidates, our ability to attract distributors and/or
commercial partners with the ability to fund patent litigation and
with acceptable product development, regulatory and
commercialization expertise and the benefits to be derived from
such collaborative efforts, sources of revenues and anticipated
revenues, including contributions from distributors and commercial
partners, product sales, license agreements and other collaborative
efforts for the development and commercialization of product
candidates, our ability to create an effective direct sales and
marketing infrastructure for products we elect to market and sell
directly, the rate and degree of market acceptance of our products,
delays in product approvals that may be caused by changing
regulatory requirements, the difficulty in predicting the timing of
regulatory approval and launch of competitive products, the
difficulty in predicting the impact of competitive products on
volume, pricing, rebates and other allowances, the number of
competitive product entries, and the nature and extent of any
aggressive pricing and rebate activities that may follow, the
inability to forecast wholesaler demand and/or wholesaler buying
patterns, seasonal fluctuations in the number of prescriptions
written for our generic Focalin XR® capsules and our generic
Seroquel XR® tablets which may produce substantial
fluctuations in revenue, the timing and amount of insurance
reimbursement regarding our products, changes in laws and
regulations affecting the conditions required by the FDA for
approval, testing and labeling of drugs including abuse or overdose
deterrent properties, and changes affecting how opioids are
regulated and prescribed by physicians, changes in laws and
regulations, including Medicare and Medicaid, affecting among other
things, pricing and reimbursement of pharmaceutical products, the
effect of recently-enacted changes in U.S. federal income tax laws,
including but not limited to, limitations on the deductibility of
business interest, limitations on the use of net operating losses
and application of the base erosion minimum tax, on our U.S.
corporate income tax burden, the success and pricing of other
competing therapies that may become available, our ability to
retain and hire qualified employees, the availability and pricing
of third-party sourced products and materials, challenges related
to the development, commercialization, technology transfer,
scale-up, and/or process validation of manufacturing processes for
our products or product candidates, the manufacturing capacity of
third-party manufacturers that we may use for our products,
potential product liability risks, the recoverability of the cost
of any pre-launch inventory, should a planned product launch
encounter a denial or delay of approval by regulatory bodies, a
delay in commercialization, or other potential issues, the
successful compliance with FDA, Health Canada and other
governmental regulations applicable to us and our third party
manufacturers' facilities, products and/or businesses, our reliance
on commercial partners, and any future commercial partners, to
market and commercialize our products and, if approved, our product
candidates, difficulties, delays or changes in the FDA approval
process or test criteria for ANDAs and NDAs, challenges in securing
final FDA approval for our product candidates, including our
oxycodone hydrochloride extended release tablets product candidate,
in particular, if a patent infringement suit is filed against us
with respect to any particular product candidates (such as in the
case of Oxycodone ER), which could delay the FDA's final approval
of such product candidates, healthcare reform measures that could
hinder or prevent the commercial success of our products and
product candidates, the FDA may not approve requested product
labeling for our product candidate(s) having abuse-deterrent
properties and targeting common forms of abuse (oral, intra-nasal
and intravenous), risks associated with cyber-security and the
potential for vulnerability of our digital information or the
digital information of a current and/or future drug development or
commercialization partner of ours, and risks arising from the
ability and willingness of our third-party commercialization
partners to provide documentation that may be required to support
information on revenues earned by us from those commercialization
partners. Additional risks and uncertainties relating to us and our
business can be found in the "Risk Factors" section of our latest
annual information form, our latest Form 20-F, and our latest Form
F-1 and Form F-3 (including any documents forming a part thereof or
incorporated by reference therein), as amended, as well as in our
reports, public disclosure documents and other filings with the
securities commissions and other regulatory bodies in Canada and
the U.S., which are available on www.sedar.com and www.sec.gov. The
forward-looking statements reflect our current views with respect
to future events and are based on what we believe are reasonable
assumptions as of the date of this document and we disclaim any
intention and have no obligation or responsibility, except as
required by law, to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Trademarks used herein are the property of their respective
holders.
Unless the context otherwise requires, all references to
“we,” “us,” “our,”
“Intellipharmaceutics,” and the “Company”
refer to Intellipharmaceutics International Inc. and its
subsidiaries.
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Company Contact:
Intellipharmaceutics
International Inc.
Dr. Isa
Odidi
Chairman,
Chief Executive Officer and Co-Chief Scientist
416-854-0909
investors@intellipharmaceutics.com
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Investor Contact:
ProActive
Capital
Kirin
Smith
646-863-6519
ksmith@proactivecapital.com
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