[_]
[X]
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[_]
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 20-F
REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT
OF 1934
OR
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended November 30, 2014
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
OR
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
Date of event requiring this shell company report …………
For the transition period from ________ to ________
Commission File No. 0-53805
INTELLIPHARMACEUTICS
INTERNATIONAL INC.
(Exact name of registrant as specified in its charter)
Canada
(Jurisdiction of Incorporation or organization)
30 Worcester Road
Toronto, Ontario M9W 5X2
(Address of principal executive offices)
Domenic Della Penna, Chief Financial Officer, Intellipharmaceutics International Inc., 30 Worcester Road, Toronto, Ontario M9W
5X2, Telephone: (416) 798-3001, Fax: (416) 798-3007
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b) of the Act:
Title of each class
Common shares, no par value
Name of each exchange
on which registered
NASDAQ
TSX
Securities registered or to be registered pursuant to Section 12(g) of the Act:
None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
None
As of November 30, 2014, the registrant had 23,456,611 common shares outstanding.
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes [_] No [X]
If this report is an annual report or transition report, indicate by check mark if the registrant is not required to file reports pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and
(2) has been subject to such filing requirements for the past 90 days.
Yes [_] No [X]
Yes [X] No [_]
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every
Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T(§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes [X] No [_]
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See
definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer [_] Accelerated filer [_] Non-accelerated filer [X]
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP [X]
International Financial Reporting Standards as issued by the International
Accounting Standards Board [_]
Other [_]
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the
registrant has elected to follow:
Item 17 [_] Item 18 [_]
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes [_] No [X]
TABLE OF CONTENTS
Part I.
Item 1. Identity of Directors, Senior Management and Advisors
Item 2. Offer Statistics and Expected Timetable
Item 3. Key Information
A. Selected Financial Data
B. Capitalization and Indebtedness
C. Reasons for the Offer and Use of Proceeds
D. Risk Factors
Item 4. Information on the Company
A. History and Development of the Company
B. Business Overview
C. Organizational Structure
D. Property, Plant and Equipment
Unresolved Staff Comments.
Item
4A.
Item 5. Operating and Financial Review and Prospects
A. Operating Results
B. Liquidity and Capital Resources
C. Research and development, patents, and licenses, etc
D. Trend Information
E. Off-balance sheet arrangements
F. Tabular disclosure of contractual obligations
G. Safe Harbor
Item 6. Directors, Senior Management and Employees
A. Directors and Senior Management
B. Compensation
C. Board Practices
D. Employees
E. Share Ownership
Item 7. Major Shareholders and Related Party Transactions
A. Major Shareholders
B. Related Party Transactions
Item 8. Financial Information
A. Consolidated Statements and Other Financial Information
B. Significant changes
Item 9. The Offer and Listing
Item 10.Additional Information
A. Share Capital
B. Articles and By-laws
C. Material Contracts
D. Exchange Controls
E. Taxation
F. Dividends and Paying Agents
G. Statement by Experts
H. Documents on Display
Subsidiary Information
I.
Item 11.Qualitative and Quantitative Disclosures about Market Risk
Item 12.Description of Securities Other than Equity Securities
Part II.
Item 13.Defaults, Dividends Arrearages and Delinquencies
Item 14.Material Modifications to the Rights of Security Holders and Use of Proceeds
Item 15.Controls and Procedures
Item
16A.
Item
16B.
Audit Committee Financial Expert
Code of Ethics
Page
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3
4
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23
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TABLE OF CONTENTS
(continued)
Principal Accountant Fees and Services
Exemptions from the Listing Standards for Audit Committees
Purchases of Equity Securities by the Issuer and Affiliated Purchases
Change in Registrant’s Certifying Accountant
Corporate Governance
Mine Safety Disclosure
Financial Statements
Financial Statements
Exhibits
Item
16C.
Item
16D.
Item
16E.
Item
16F.
Item
16G.
Item
16H.
Part III.
Item
17
Item
18
Item
19
ii
Page
91
91
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93
DISCLOSURE REGARDING FORWARD-LOOKING INFORMATION
Certain statements in this annual report 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 plans, goals and milestones, status of developments or expenditures relating to our
business, plans to fund our current activities, 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 “may”, “will”, “should”, “expects”, “plans”, “anticipates”, “believes”,
“estimates”, “predicts”, “potential”, “continue”, “intends”, “could”, 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 potential dilutive
effects of any future financing and the expected use of any proceeds from any offering of our securities, 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 timing and amount of any available investment tax credits
(“ITCs”). Other factors that could cause actual results to differ materially include but are not limited to:
•
•
•
•
•
•
•
•
•
•
•
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 for our drug delivery technologies, products and product candidates;
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 collaborators with the ability to fund patent litigation and with acceptable 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 collaborators, 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;
the difficulty of predicting the impact of competitive products and pricing and the timing and success of product launches;
the seasonal fluctuation in the numbers of prescriptions written for our dexmethylphenidate hydrochloride extended-release capsules
which may produce substantial fluctuations in revenues;
-1-
•
•
•
•
•
•
•
•
the timing and amount of insurance reimbursement for our products;
changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of
pharmaceutical products;
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;
difficulties or delays in manufacturing;
the manufacturing capacity of third-party manufacturers that we may use for our products; and
the successful compliance with United States Food and Drug Administration (“ FDA”) and other governmental regulations
applicable to us and our third party manufacturers’ facilities, products and/or businesses.
Additional risks and uncertainties relating to us and our business can be found in the “Risk Factors” section in Item 3.D below, 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. 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.
Nothing contained in this document should be construed to imply that the results discussed herein will necessarily continue or that
any conclusion reached herein will necessarily be indicative of actual operating results of the Company.
In this annual report, unless the context otherwise requires, the terms “we”, “us”, “our”, “Intellipharmaceutics” and the
“Company” refer to Intellipharmaceutics International Inc. and its subsidiaries. Any reference in this annual report to our “products”
includes a reference to our product candidates and future products we may develop. In this annual report, we refer to information regarding
potential markets for our products, product candidates and other industry data. We believe that all such information has been obtained from
reliable sources that are customarily relied upon by companies in our industry. However, we have not independently verified any such
information.
IntellipharmaceuticsTM, HypermatrixTM, Drug Delivery EngineTM, IntelliFoamTM, IntelliGITransporterTM, IntelliMatrixTM,
IntelliOsmoticsTM, IntelliPasteTM, IntelliPelletsTM, IntelliShuttleTM , RexistaTM, nPODDDSTM and RegabatinTM are our trademarks.
These trademarks are important to our business. Although we may have omitted the “TM” trademark designation for such trademarks in
this annual report, all rights to such trademarks are nevertheless reserved. Unless otherwise noted, other trademarks used in this annual
report are the property of their respective holders.
Item 1.
Identity of Directors, Senior Management and Advisers
PART I.
A.
Directors and senior management
Not applicable.
B.
Advisors
Not applicable.
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C.
Auditors
Not applicable.
Item 2.
Offer Statistics and Expected Timetable
A.
Offer statistics
Not applicable.
B.
Method and expected timetable
Not applicable.
Item 3.
Key Information
A.
Selected Financial Data
The following selected financial data of Intellipharmaceutics has been derived from the audited consolidated financial statements
of the Company as at and for the years ended November 30, 2014, 2013, 2012, 2011 and 2010. As a result of the IPC Arrangement
Transaction (as defined and described in Item 4.A below) completed on October 22, 2009, we selected a November 30 year end. The
comparative number of shares issued and outstanding, basic and diluted loss per share have been amended to give effect to this arrangement
transaction. These statements were prepared in accordance with accounting principles generally accepted in the United States of America
(“U.S. GAAP”). All dollar amounts in this annual report are expressed in United States dollars (“U.S. dollars”), unless otherwise indicated.
(in thousands, except for per share data)
As at and for
the year ended
November 30,
2014
As at and for
the year ended
November 30,
2013
As at and for
the year ended
November 30,
2012
As at and for
the year ended
November 30,
2011
As at and for
the year ended
November 30,
2010
8,770
-3,856
7,875
2,966
4,909
18,941
-0.17
Nil
23,051
1,527
-11,495
4,380
10,335
-5,955
11,721
-0.58
Nil
19,671
107
-6,137
2,475
4,243
-1,768
6,129
-0.36
Nil
17,259
502
-4,880
6,247
9,340
-3,093
902
-0.33
Nil
14,994
1,459
-5,761
3,268
3,175
93
17
-0.53
Nil
10,907
Revenue
Loss for the period
Total assets
Total liabilities
Net assets
Capital stock
Loss per share - basic and diluted
Dividends
Weighted average common shares
The following table sets forth the average exchange rate for one Canadian dollar expressed in terms of one U.S. dollar for the fiscal
years 2010, 2011, 2012, 2013 and 2014. The average rate is calculated using the average of the exchange rates on the last day of each
month during the period.
2010
2011
2012
2013
2014
AVERAGE
0.9673
1.0123
0.9977
1.0241
0.9115
-3-
The following table sets forth the high and low exchange rates for each month during the previous six months.
August 2014
September 2014
October 2014
November 2014
December 2014
January 2015
February 2015 (through February 23, 2015)
LOW
0.9106
0.8922
0.8858
0.8751
0.8589
0.7863
0.7876
HIGH
0.9211
0.9206
0.8980
0.8900
0.8815
0.8527
0.8095
The exchange rates are based upon the noon buying rate as quoted by The Bank of Canada. At February 23, 2015, the exchange
rate for one Canadian dollar expressed in terms of one U.S. dollar, as quoted by The Bank of Canada at 4 p.m. Eastern Time, equaled
$0.7952.
B.
Capitalization and Indebtedness
Not Applicable.
C.
Reasons for the Offer and Use of Proceeds
Not Applicable.
D.
Risk Factors
Prospects for companies in the pharmaceutical industry generally may be regarded as uncertain given the research and
development nature of the industry and uncertainty regarding the prospects of successfully commercializing product candidates and,
accordingly, investments in companies such as ours should be regarded as very speculative. An investor should carefully consider the risks
and uncertainties described below, as well as other information contained in this annual report. The list of risks and uncertainties described
below is not an exhaustive list. Additional risks and uncertainties not presently known to us or that we believe to be immaterial may also
adversely affect our business. If any one or more of the following risks occur, our business, financial condition and results of operations
could be seriously harmed. Further, if we fail to meet the expectations of the public market in any given period, the market price of our
common shares could decline. If any of the following risks actually occurs, our business, operating results, or financial condition could be
materially adversely affected.
Our activities entail significant risks. In addition to the usual risks associated with a business, the following is a general description
of certain significant risk factors which may be applicable to us.
Risks related to our Company
Our business is capital intensive and requires significant investment to conduct research and development, clinical and regulatory
activities necessary to bring our products to market, which capital may not be available in amounts or on terms acceptable to us, if
at all.
Our business requires substantial capital investment in order to conduct the research and development, clinical and regulatory
activities necessary to bring our products to market and to establish commercial manufacturing, marketing and sales capabilities. As of
November 30, 2014, we had a cash balance of $4.2 million. As of February 23, 2015, our cash balance was $4.4 million, which we expect
will fund our currently projected operations through May 2015. In order for us to continue operations at currently projected levels beyond
May 2015, we will be required to seek significant additional capital. We might also need further additional capital to fund any R&D
activities which are at higher-than-currently projected levels and to fund any significant expansion of our operations. Although there can be
no assurances, such capital may come from proceeds of our at-the-market offering program (see “Share Capital – Prior Sales”, in Item 10,
below for a further description of our at-the-market offering program), from sales of our generic Focalin XR ® (dexmethylphenidate
hydrochloride extended-release) capsules, and from potential partnering opportunities. Other potential sources of capital may include
payments from licensing agreements, cost savings associated with managing operating expense levels, other equity and/or debt financings,
-4-
and/or new strategic partnership agreements which fund some or all costs of product development, although there can be no assurance that
we will be able to obtain any such capital on terms or in amounts sufficient to meet our needs or at all. The increase in expenses in 2014
was in part as a result of capital expenditures on production and analytical equipment and expenses for the procurement of active raw
materials, conducting clinical studies and, to a lesser extent, hiring of additional personnel. We do not anticipate any material equipment
purchases in the next twelve months in the absence of significant additional funding. Effective October 1, 2014, the January 1, 2015
maturity date for the debenture in respect of the $1,500,000 loan to the Company by Drs. Isa and Amina Odidi (the “Debenture”) was
extended, to July 1, 2015. The Company currently expects to repay this amount from then available cash on or by July 1, 2015. Our
ultimate success will depend on whether our product candidates receive the approval of the FDA or other applicable regulatory agencies
and we are able to successfully market approved products. We cannot be certain that we will be able to receive FDA approval for any of
our current or future product candidates, or that we will reach the level of sales and revenues necessary to achieve and sustain profitability.
The availability of equity or debt financing will be affected by, among other things, the results of our research and development, our ability
to obtain regulatory approvals, the market acceptance of our products, the state of the capital markets generally, strategic alliance
agreements, and other relevant commercial considerations. In addition, if we raise additional funds by issuing equity securities, our then
existing security holders will likely experience dilution, and the incurring of indebtedness would result in increased debt service obligations
and could require us to agree to operating and financial covenants that would restrict our operations. In the event that we do not obtain
additional sufficient capital, there may be substantial doubt about our ability to continue as a going concern and realize our assets and pay
our liabilities as they become due. Depending upon the results of our research and development programs and the availability of financial
resources, we could decide to accelerate, terminate, or reduce certain projects, or commence new ones. Any failure on our part to raise
additional funds on terms favorable to us or at all, may require us to significantly change or curtail our current or planned operations in
order to conserve cash until such time, if ever, that sufficient proceeds from operations are generated, and could result in our not taking
advantage of business opportunities, in the termination or delay of clinical trials or us not taking any necessary actions required by the FDA
for one or more of our product candidates, in curtailment of our product development programs designed to identify new product
candidates, in the sale or assignment of rights to our technologies, products or product candidates, and/or our inability to file abbreviated
new drug applications (“ANDAs”) or new drug applications (“NDAs”) at all or in time to competitively market our products or product
candidates.
Delays, suspensions and terminations in our preclinical studies and clinical trials could result in increased costs to us and delay our
ability to generate product revenues.
The commencement of clinical trials can be delayed for a variety of reasons, including delays in:
•
•
demonstrating sufficient safety and efficacy to obtain regulatory approval to commence a clinical trial;
reaching agreement on acceptable terms with prospective contract research organizations and clinical trial sites;
• manufacturing sufficient quantities of a drug candidate;
•
•
•
obtaining institutional review board approval to conduct a clinical trial at a prospective clinical trial site;
patient enrollment; and
for controlled substances, obtaining specific permission to conduct a study, and obtaining import and export permits to ship study
samples.
Once a clinical trial has begun, it may be delayed, suspended or terminated due to a number of factors, including:
•
•
•
the number of patients that participate in the trial;
the length of time required to enroll suitable subjects;
the duration of patient follow-up;
-5-
•
•
•
•
•
•
the number of clinical sites included in the trial;
changes in regulatory requirements or regulatory delays or clinical holds requiring suspension or termination of the trials;
delays, suspensions or termination of clinical trials due to the institutional review board overseeing the study at a particular site;
failure to conduct clinical trials in accordance with regulatory requirements;
unforeseen safety issues, including serious adverse events or side effects experienced by participants; and
inability to manufacture, through third party manufacturers, adequate supplies of the product candidate being tested.
Based on results at any stage of product development, we may decide to repeat or redesign preclinical studies or clinical trials, conduct
entirely new studies or discontinue development of products for one or all indications. In addition, our product candidates may not
demonstrate sufficient safety and efficacy in pending or any future preclinical testing or clinical trials to obtain the requisite regulatory
approvals. Even if such approvals are obtained for our products, they may not be accepted in the market as a viable alternative to other
products already approved or pending approvals.
If we experience delays, suspensions or terminations in a preclinical study or clinical trial, the commercial prospects for our products
will be harmed, and our ability to generate product revenues will be delayed or we may never be able to generate such revenues.
We have a history of operating losses, which may continue in the foreseeable future.
We have incurred net losses from inception through November 30, 2014 and had an accumulated deficit of $45.4 million as of such
date and have incurred additional losses since such date. As we engage in the development of products in our pipeline, we will continue to
incur further losses. There can be no assurance that we will ever be able to achieve or sustain future profitability or positive cash flow. Our
ultimate success will depend on whether our product candidates receive the approval of the FDA or other applicable regulatory agencies
and whether we are able to successfully market approved products. We cannot be certain that we will be able to receive FDA approval for
any of our current or future product candidates, or that we will reach the level of sales and revenues necessary to achieve and sustain
profitability.
Loss of key scientists and failure to attract qualified personnel could limit our growth and negatively impact our operations.
We are dependent upon the scientific expertise of Dr. Isa Odidi, our Chairman and Chief Executive Officer, and Dr. Amina Odidi, our
President and Chief Operating Officer. Although we employ other qualified scientists, Drs. Isa and Amina Odidi are our only employees
with the knowledge and experience necessary for us to continue development of controlled-release products. We do not maintain key-
person life insurance on any of our officers or employees. Although we have employment agreements with key members of our
management team, each of our employees may terminate his or her employment at any time. The success of our business depends, in large
part, on our continued ability to attract and retain highly qualified management, scientific, manufacturing and sales and marketing
personnel, on our ability to successfully integrate many new employees, and on our ability to develop and maintain important relationships
with leading research and medical institutions and key distributors. If we lose the services of our executive officers or other qualified
personnel or are unable to attract and retain qualified individuals to fill these roles or develop key relationships, our business, financial
condition and results of operations could be materially adversely affected.
Our intellectual property may not provide meaningful protection for our products and product candidates.
We hold certain U.S., Canadian and foreign patents and have pending applications for additional patents outstanding. We intend to
continue to seek patent protection for, or maintain as trade secrets, all of our commercially
-6-
promising drug delivery platforms and technologies. Our success depends, in part, on our and our collaborative partners’ ability to obtain
and maintain patent protection for products and product candidates, maintain trade secret protection and operate without infringing the
proprietary rights of third parties. Without patent and other similar protection, other companies could offer substantially identical products
without incurring sizeable development costs which could diminish our ability to recover expenses of and realize profits on our developed
products. If our pending patent applications are not approved, or if we are unable to obtain patents for additional developed technologies,
the future protection for our technologies will remain uncertain. Furthermore, third parties may independently develop similar or
alternative technologies, duplicate some or all of our technologies, design around our patented technologies or challenge our issued patents.
Such third parties may have filed patent applications, or hold issued patents, relating to products or processes competitive with those we are
developing or otherwise restricting our ability to do business in a particular area. If we are unable to obtain patents or otherwise protect our
trade secrets or other intellectual property and operate without infringing on the proprietary rights of others, our business, financial
condition and results of operations could be materially adversely affected.
We may be subject to intellectual property claims that could be costly and could disrupt our business.
Third parties may claim we have infringed their patents, trademarks, copyrights or other rights. We may be unsuccessful in defending
against such claims, which could result in the inability to protect our intellectual property rights or liability in the form of substantial
damages, fines or other penalties such as injunctions precluding our manufacture, importation or sales of products. The resolution of a
claim could also require us to change how we do business or enter into burdensome royalty or license agreements. Insurance coverage may
be denied or may not be adequate to cover every claim that third parties could assert against us. Even unsuccessful claims could result in
significant legal fees and other expenses, diversion of management’s time and disruptions in our business. Any of these claims could also
harm our reputation.
We rely on maintaining as trade secrets our competitively sensitive know-how and other information. Intentional or unintentional
disclosure of this information could impair our competitive position.
As to many technical aspects of our business, we have concluded that competitively sensitive information is either not patentable or
that for competitive reasons it is not commercially advantageous to seek patent protection. In these circumstances, we seek to protect this
know-how and other proprietary information by maintaining it in confidence as a trade secret. To maintain the confidentiality of our trade
secrets, we generally enter into agreements that contain confidentiality provisions with our employees, consultants, collaborators, contract
manufacturers and advisors upon commencement of their relationships with us. These provisions generally require that all confidential
information developed by the individual or made known to the individual by us during the course of the individual’s relationship with us be
kept confidential and not disclosed to third parties. We may not have these arrangements in place in all circumstances, and the
confidentiality provisions in our favour may be breached. We may not become aware of, or have adequate remedies in the event of, any
such breach. In addition, in some situations, the confidentiality provisions in our favour may conflict with, or be subject to, the rights of
third parties with whom our employees, consultants, collaborators, contract manufacturers or advisors have previous employment or
consulting relationships. To the extent that our employees, consultants, collaborators, contract manufacturers or advisors use trade secrets
or know-how owned by others in their work for us, disputes may arise as to the ownership of relative inventions. Also, others may
independently develop substantially equivalent trade secrets, processes and know-how, and competitors may be able to use this information
to develop products that compete with our products, which could adversely impact our business. The disclosure of our trade secrets could
impair our competitive position. Adequate remedies may not exist in the event of unauthorized use or disclosure of our confidential
information.
Approvals for our product candidates may be delayed or become more difficult to obtain if the FDA institutes changes to its
approval requirements.
The FDA may institute changes to its ANDA approval requirements, which may make it more difficult or expensive for us to obtain
approval for our new generic products. For instance, in July 2012, the Generic Drug Fee User Amendments of 2012 (“GDUFA”) were
enacted into law. The GDUFA legislation implemented substantial fees for new ANDAs, Drug Master Files, product and establishment fees
and a one-time fee for back-logged ANDAs pending approval as of October 1, 2012. In return, the program is intended to provide faster
and more predictable ANDA reviews by the FDA and more timely inspections of drug facilities. For the FDA’s fiscal years
-7-
2014 and 2015, respectively, the user fee rates are $63,860 and $58,730 for new ANDAs, $31,920 and $29,370 for “Prior Approval
Supplements,” and $17,434 for each ANDA already on file at the FDA. For the FDA’s fiscal year 2014 and 2015, there is also an annual
facility user fee of $235,152 and $262,717, respectively. Under GDUFA, generic product companies face significant penalties for failure to
pay the new user fees, including rendering an ANDA not “substantially complete” until the fee is paid. It is currently uncertain the effect
the new fees will have on our ANDA process and business. However, any failure by us or our suppliers to pay the fees or to comply with
the other provisions of GDUFA may adversely impact or delay our ability to file ANDAs, obtain approvals for new generic products,
generate revenues and thus may have a material adverse effect on our business, results of operations and financial condition.
We operate in a highly litigious environment.
From time to time, we are subject to legal proceedings. As of the date of this annual report, we are not aware of any pending or
threatened material litigation claims against us other than as described under Item 8.A below. Litigation to which we are, or may be, subject
could relate to, among other things, our patent and other intellectual property rights, or such rights of others, business or licensing
arrangements with other persons, product liability or financing activities. Such litigation could include an injunction against the
manufacture or sale of one or more of our products or potential products or a significant monetary judgment, including a possible punitive
damages award, or a judgment that certain of our patent or other intellectual property rights are invalid or unenforceable or infringe the
intellectual property rights of others. If such litigation is commenced, our business, results of operations, financial condition and cash flows
could be materially adversely affected.
There has been substantial litigation in the pharmaceutical industry concerning the manufacture, use and sale of new products that are
the subject of conflicting patent rights. When we file an ANDA for a bioequivalent version of a drug, we may, in some circumstances, be
required to certify to the FDA that any patent which has been listed with the FDA as covering the branded product has expired, the date any
such patent will expire, or that any such patent is invalid or will not be infringed by the manufacture, sale or use of the new drug for which
the application is submitted. Approval of an ANDA is not effective until each listed patent expires, unless the applicant certifies that the
patents at issue are not infringed or are invalid and so notifies the patent holder and the holder of the branded product. A patent holder may
challenge a notice of non-infringement or invalidity by suing for patent infringement within 45 days of receiving notice. Such a challenge
prevents FDA approval for a period which ends 30 months after the receipt of notice, or sooner if an appropriate court rules that the patent
is invalid or not infringed. From time to time, in the ordinary course of business, we face and have faced such challenges and may continue
to do so in the future.
Brand-name pharmaceutical manufacturers routinely bring patent infringement litigation against ANDA applicants seeking FDA
approval to manufacture and market generic forms of their branded products. We are routinely subject to patent litigation that can delay or
prevent our commercialization of products, force us to incur substantial expense to defend, and expose us to substantial liability.
We cannot ensure the availability of raw materials.
Certain raw materials necessary for the development and subsequent commercial manufacture of our product candidates may be
proprietary products of other companies. While we attempt to manage the risk associated with such proprietary raw materials, if our efforts
fail, or if there is a material shortage, contamination, and/or recall of such materials, the resulting scarcity could adversely affect our ability
to develop or manufacture our product candidates. In addition, many third party suppliers are subject to governmental regulation and,
accordingly, we are dependent on the regulatory compliance of, as well as on the strength, enforceability and terms of our various contracts
with, these third party suppliers.
Further, the FDA requires identification of raw material suppliers in applications for approval of drug products. If raw materials are
unavailable from a specified supplier, the supplier does not give us access to its technical information for our application or the supplier is
not in compliance with FDA or other applicable requirements, FDA approval of the supplier could delay the manufacture of the drug
involved. Any inability to obtain raw materials on a timely basis, or any significant price increases which cannot be passed on to customers,
could have a material adverse effect on our business, results of operations, financial condition and cash flows.
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Our product candidates may not be successfully developed or commercialized.
Successful development of our product candidates is highly uncertain and is dependent on numerous factors, many of which are
beyond our control. Products that appear promising in research or early phases of development may fail to reach later stages of
development or the market for several reasons including:
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for ANDA candidates, bioequivalence studies results may not meet regulatory requirements or guidelines for the demonstration of
bioequivalence;
for NDA candidates, a product may not demonstrate acceptable large-scale clinical trial results, even though it demonstrated
positive preclinical or initial clinical trial results;
for NDA candidates, a product may not be effective in treating a specified condition or illness;
a product may have harmful side effects on humans;
products may fail to receive the necessary regulatory approvals from the FDA or other regulatory bodies, or there may be delays in
receiving such approvals;
difficulties may be encountered in formulating products, scaling up manufacturing processes or in getting approval for
manufacturing;
• manufacturing costs, pricing or reimbursement issues, other competitive therapeutics, or other commercial factors may make the
product uneconomical; and
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the proprietary rights of others, and their competing products and technologies, may prevent the product from being developed or
commercialized.
Further, success in preclinical and early clinical trials does not ensure that large-scale clinical trials will be successful, nor does success
in preliminary studies for ANDA candidates ensure that bioequivalence studies will be successful. Results are frequently susceptible to
varying interpretations that may delay, limit or prevent regulatory approvals. The length of time necessary to complete bioequivalence
studies or clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly
and may be difficult to predict.
As a result, there can be no assurance that any of our product candidates currently in development will ever be successfully
commercialized.
Near-term revenue depends significantly on the success of our first filed ANDA (“lead”) product, our once daily
dexmethylphenidate hydrochloride extended-release generic.
We have invested significant time and effort in the development of our lead product, our once daily generic Focalin XR®
(dexmethylphenidate hydrochloride extended-release) capsules, which received final FDA approval for the 15 and 30 mg strengths in
November 2013. Our 5, 10, 20 and 40 mg strengths were also tentatively FDA approved, subject to the right of another party or parties to
180 days of generic exclusivity from the date of first launch of such products by such parties. We believe that our development partner, Par
Pharmaceutical, Inc. (“Par”), intends to launch these strengths immediately upon the expiry of those exclusivity periods, but there can be
no assurance as to when or if any launch will occur. There can be no assurance as to when or if final FDA approval will be received for the
remaining product strengths we have applied for or that any of these strengths tentatively approved will ever be successfully
commercialized. We depend significantly on the actions of our development partner Par in the prosecution, regulatory approval and
commercialization of our generic dexmethylphenidate hydrochloride extended-release products and on their timely payment to us of the
contracted quarterly payments as they come due. Our near term ability to generate significant revenue will depend upon successful
commercialization of this product in the United States, where the branded Focalin XR® product is in the market. Although we have several
other products in our pipeline, they are at earlier stages of development.
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Our significant expenditures on research and development may not lead to successful product introductions.
We conduct research and development primarily to enable us to manufacture and market pharmaceuticals in accordance with FDA
regulations. Typically, research expenses related to the development of innovative compounds and the filing of NDAs are significantly
greater than those expenses associated with ANDAs. As we continue to develop new products, our research expenses will likely increase.
We are required to obtain FDA approval before marketing our drug products and the approval process is costly and time consuming.
Because of the inherent risk associated with research and development efforts in our industry, particularly with respect to new drugs, our
research and development expenditures may not result in the successful introduction of FDA approved new pharmaceuticals.
We may not have the ability to develop or license, or otherwise acquire, and introduce new products on a timely basis.
Product development is inherently risky, especially for new drugs for which safety and efficacy have not been established and the
market is not yet proven. Likewise, product licensing involves inherent risks including uncertainties due to matters that may affect the
achievement of milestones, as well as the possibility of contractual disagreements with regard to terms such as license scope or termination
rights. The development and commercialization process, particularly with regard to new drugs, also requires substantial time, effort and
financial resources. The process of obtaining FDA or other regulatory approval to manufacture and market new and generic pharmaceutical
products is rigorous, time consuming, costly and largely unpredictable. We, or a partner, may not be successful in obtaining FDA or other
required regulatory approval or in commercializing any of the product candidates that we are developing or licensing.
We may not achieve our projected development goals in the time frames we announce and expect.
We set goals regarding the expected timing of meeting certain corporate objectives, such as the commencement and completion of
clinical trials, anticipated regulatory approval and product launch dates. From time to time, we may make certain public statements
regarding these goals. The actual timing of these events can vary dramatically due to, among other things, insufficient funding, delays or
failures in our clinical trials or bioequivalence studies, the uncertainties inherent in the regulatory approval process, such as requests for
additional information, delays in achieving manufacturing or marketing arrangements necessary to commercialize our product candidates
and failure by our collaborators, marketing and distribution partners, suppliers and other third parties to fulfill contractual obligations.
Our products may not achieve expected levels of market acceptance, thereby limiting our potential to generate revenue.
Even if we are able to obtain regulatory approvals for our product candidates, the success of any of our products will be dependent
upon market acceptance. Levels of market acceptance for any products marketed by us could be affected by several factors, including:
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the availability of alternative products from competitors;
the prices of our products relative to those of our competitors;
the timing of our market entry;
the ability to market our products effectively at the retail level; and
the acceptance of our products by government and private formularies.
Some of these factors are not within our control, and our proposed products may not achieve levels of market acceptance anticipated by us.
Additionally, continuing and increasingly sophisticated studies of the proper utilization, safety and efficacy of pharmaceutical products are
being conducted by the industry, government agencies and others which can call into question the utilization, safety and efficacy of our
products and any product candidates we are currently developing or may develop in the future. These studies could also impact a future
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product after it has been marketed. In some cases, studies have resulted, and may in the future result, in the discontinuance of product
marketing or requirement of other risk management programs such as the need for a patient registry. The failure of our products and any of
our product candidates, once approved, to achieve market acceptance would limit our ability to generate revenue and would adversely
affect our results of operations.
The risks and uncertainties inherent in conducting clinical trials could delay or prevent the development and commercialization of
our own branded products, which could have a material adverse effect on our results of operations, liquidity, financial condition,
and growth prospects.
There are a number of risks and uncertainties associated with clinical trials, which may be exacerbated by our relatively limited experience
in conducting and supervising clinical trials and preparing NDAs. The results of initial clinical trials may not be indicative of results that
would be obtained from large scale testing. Clinical trials are often conducted with patients having advanced stages of disease and, as a
result, during the course of treatment these patients can die or suffer adverse medical effects for reasons that may not be related to the
pharmaceutical agents being tested, but which nevertheless affect the clinical trial results. In addition, side effects experienced by the
patients may cause delay of approval of our product candidates or a limited application of an approved product. Moreover, our clinical
trials may not demonstrate sufficient safety and efficacy to obtain FDA approval.
Failure can occur at any time during the clinical trial process and, in addition, the results from early clinical trials may not be predictive of
results obtained in later and larger clinical trials, and product candidates in later clinical trials may fail to show the desired safety or efficacy
despite having progressed successfully through earlier clinical testing. A number of companies in the pharmaceutical industry have suffered
significant setbacks in clinical trials, even in advanced clinical trials after showing positive results in earlier clinical trials. In the future, the
completion of clinical trials for our product candidates may be delayed or halted for many reasons, including those relating to the
following:
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delays in patient enrollment, and variability in the number and types of patients available for clinical trials;
regulators or institutional review boards may not allow us to commence or continue a clinical trial;
our inability, or the inability of our partners, to manufacture or obtain from third parties materials sufficient to complete our clinical
trials;
delays or failures in reaching agreement on acceptable clinical trial contracts or clinical trial protocols with prospective clinical trial
sites;
risks associated with trial design, which may result in a failure of the trial to show statistically significant results even if the product
candidate is effective;
difficulty in maintaining contact with patients after treatment commences, resulting in incomplete data;
poor effectiveness of product candidates during clinical trials;
safety issues, including adverse events associated with product candidates;
the failure of patients to complete clinical trials due to adverse side effects, dissatisfaction with the product candidate, or other
reasons;
governmental or regulatory delays or changes in regulatory requirements, policy and guidelines; and
varying interpretation of data by the FDA or other applicable foreign regulatory agencies.
In addition, our product candidates could be subject to competition for clinical study sites and patients from other therapies under
development by other companies which may delay the enrollment in or initiation of our clinical trials. Many of these companies have
significantly more resources than we do.
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The FDA or other foreign regulatory authorities may require us to conduct unanticipated additional clinical trials, which could result in
additional expense and delays in bringing our product candidates to market. Any failure or delay in completing clinical trials for our
product candidates would prevent or delay the commercialization of our product candidates. There can be no assurance our expenses
related to clinical trials will lead to the development of brand-name drugs which will generate revenues in the near future. Delays or failure
in the development and commercialization of our own branded products could have a material adverse effect on our results of operations,
liquidity, financial condition, and our growth prospects.
We rely on third parties to conduct clinical trials for our product candidates, and if they do not properly and successfully perform
their legal and regulatory obligations, as well as their contractual obligations to us, we may not be able to obtain regulatory
approvals for our product candidates.
We design the clinical trials for our product candidates, but rely on contract research organizations and other third parties to assist us in
managing, monitoring and otherwise carrying out these trials, including with respect to site selection, contract negotiation and data
management. We do not control these third parties and, as a result, they may not treat our clinical studies as their highest priority, or in the
manner in which we would prefer, which could result in delays. Although we rely on third parties to conduct our clinical trials, we are
responsible for confirming that each of our clinical trials is conducted in accordance with our general investigational plan and protocol.
Moreover, the FDA and foreign regulatory agencies require us to comply with regulations and standards, commonly referred to as good
clinical practices, for conducting, recording and reporting the results of clinical trials to ensure that the data and results are credible and
accurate and that the trial participants are adequately protected. Our reliance on third parties does not relieve us of these responsibilities
and requirements. The FDA enforces good clinical practices through periodic inspections of trial sponsors, principal investigators and trial
sites. If we, our contract research organizations or our study sites fail to comply with applicable good clinical practices, the clinical data
generated in our clinical trials may be deemed unreliable and the FDA may require us to perform additional clinical trials before approving
our marketing applications. There can be no assurance that, upon inspection, the FDA will determine that any of our clinical trials comply
with good clinical practices. In addition, our clinical trials must be conducted with product manufactured under the FDA’s current Good
Manufacturing Practices (“cGMP”) regulations. Our failure, or the failure of our contract manufacturers, if any are involved in the process,
to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.
If third parties do not successfully carry out their duties under their agreements with us; if the quality or accuracy of the data they obtain is
compromised due to failure to adhere to our clinical protocols or regulatory requirements; or if they otherwise fail to comply with clinical
trial protocols or meet expected deadlines, our clinical trials may not meet regulatory requirements. If our clinical trials do not meet
regulatory requirements or if these third parties need to be replaced, such clinical trials may be extended, delayed, suspended or terminated.
If any of these events occur, we may not be able to obtain regulatory approval of our product candidates, which could have a material
adverse effect on our results of operations, financial condition and growth prospects.
Competition in our industry is intense, and developments by other companies could render our products and product candidates
obsolete.
Many of our competitors, including medical technology, pharmaceutical or biotechnology and other companies, universities, government
agencies, or research organizations, have substantially greater financial and technical resources and production and marketing capabilities
than we have. They also may have greater experience in conducting bioequivalence studies, preclinical testing and clinical trials of
pharmaceutical products, obtaining FDA and other regulatory approvals, and ultimately commercializing any approved products. Therefore,
our competitors may succeed in developing and commercializing technologies and products that are more effective than the drug delivery
technologies we have developed or we are developing or that will cause our technologies or products to become obsolete or non-
competitive, and in obtaining FDA approval for products faster than we could. These developments could render our products obsolete and
uncompetitive, which would have a material adverse effect on our business, financial condition and results of operations. Even if we
commence further commercial sales of our products, we will be competing against the greater manufacturing efficiency and marketing
capabilities of our competitors, areas in which we have limited or no experience.
We rely on collaborative arrangements with third parties that provide manufacturing and/or marketing support for some or all of our
products and product candidates. Even if we find a potential partner, we may not be able to
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negotiate an arrangement on favourable terms or achieve results that we consider satisfactory. In addition, such arrangements can be
terminated under certain conditions and do not assure a product’s success. We also face intense competition for collaboration arrangements
with other pharmaceutical and biotechnology companies.
Although we believe that our ownership of patents for some of our drug delivery products will limit direct competition with these products,
we must also compete with established existing products and other promising technologies and other products and delivery alternatives that
may be more effective than our products and proposed products. In addition, we may not be able to compete effectively with other
commercially available products or drug delivery technologies.
We require regulatory approvals for any products that use our drug delivery technologies.
Our drug delivery technologies can be quite complex, with many different components. The development required to take a technology
from its earliest stages to its incorporation in a product that is sold commercially can take many years and cost a substantial amount of
money. Significant technical challenges are common as additional products incorporating our technologies progress through development.
Any particular technology such as our abuse-deterrent technology may not perform in the same manner when used with different
therapeutic agents, and therefore this technology may not prove to be as useful or valuable as originally thought, resulting in additional
development work.
If our efforts do not repeatedly lead to successful development of product candidates, we may not be able to grow our pipeline or to enter
into agreements with marketing and distribution partners or collaborators that are willing to distribute or develop our product candidates.
Delays or unanticipated increases in costs of development at any stage, or failure to solve a technical challenge, could adversely affect our
operating results.
If contract manufacturers fail to devote sufficient time and resources to our concerns, or if their performance is substandard, the
commercialization of our products could be delayed or prevented, and this may result in higher costs or deprive us of potential
product revenues.
We rely on contract manufacturers for certain components and ingredients of our clinical trial materials, such as active pharmaceutical
ingredients (“APIs”), and we may rely on such manufacturers for commercial sales purposes as well. Our reliance on contract
manufacturers in these respects will expose us to several risks which could delay or prevent the commercialization of our products, result in
higher costs, or deprive us of potential product revenues, including:
• Difficulties in achieving volume production, quality control and quality assurance, or technology transfer, as well as with shortages
of qualified personnel;
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The failure to establish and follow cGMP and to document adherence to such practices;
The need to revalidate manufacturing processes and procedures in accordance with FDA and other nationally mandated cGMPs and
potential prior regulatory approval upon a change in contract manufacturers;
Failure to perform as agreed or to remain in the contract manufacturing business for the time required to produce, store and
distribute our products successfully;
The potential for an untimely termination or non-renewal of contracts; and
The potential for us to be in breach of our collaboration and marketing and distribution arrangements with third parties for the
failure of our contract manufacturers to perform their obligations to us.
In addition, drug manufacturers are subject to ongoing periodic unannounced inspection by the FDA and corresponding state and foreign
agencies to ensure strict compliance with cGMP and other government regulations. While we may audit the performance of third-party
contractors, we will not have complete control over their compliance with these regulations and standards. Failure by either our third-party
manufacturers or by us to comply
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with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, failure of applicable
regulatory authorities to grant review of submissions or market approval of drugs, delays, suspension or withdrawal of approvals, product
seizures or recalls, operating restrictions, facility closures and criminal prosecutions, any of which could harm our business.
We are subject to currency rate fluctuations that may impact our financial results.
A large majority of our expenses are payable in Canadian dollars and our financial results are reported in U.S. dollars. There may be
instances where we have net foreign currency exposure. Any fluctuations in exchange rates will impact our financial results.
We have limited sales, marketing and distribution experience.
We have limited experience in the sales, marketing, and distribution of pharmaceutical products. There can be no assurance that, if
required, we would be able to establish sales, marketing, and distribution capabilities or make arrangements with our collaborators,
licensees, or others to perform such activities or that such efforts would be successful. If we fail to establish successful marketing and sales
capabilities or to make arrangements with third parties, our business, financial condition and results of operations will be materially
adversely affected.
Our significant shareholders have the ability to exercise significant influence over certain corporate actions.
Our principal shareholders, Drs. Amina and Isa Odidi, our President and Chief Operating Officer and our Chairman and Chief Executive
Officer, respectively, and Odidi Holdings Inc., a privately-held company controlled by Drs. Amina and Isa Odidi, owned in the aggregate
approximately 25.5% of our issued and outstanding common shares as of the date of this annual report (and collectively beneficially owned
in the aggregate approximately 34.0% of our common shares, including common shares issuable upon the exercise of outstanding options
and the conversion of the Debenture held by Drs. Amina and Isa Odidi that are exercisable or convertible within 60 days of the date
hereof). As a result, the principal shareholders have the ability to exercise significant influence over all matters submitted to our
shareholders for approval whether subject to approval by a majority of holders of our common shares or subject to a class vote or special
resolution requiring the approval of 66⅔% of the votes cast by holders of our common shares, in person or by proxy.
Our effective tax rate may vary.
Various internal and external factors may have favorable or unfavorable effects on our future effective tax rate. These factors include, but
are not limited to, changes in tax laws, regulations and/or rates, changing interpretations of existing tax laws or regulations, future levels of
research and development spending, the availability of tax credit programs for the reimbursement of all or a significant proportion of
research and development spending, and changes in overall levels of pre-tax earnings. At present, we qualify in Canada for certain research
tax credits for qualified scientific research and experimental development pertaining to our drug delivery technologies and drug products in
research stages. If Canadian tax laws relating to research tax credits were substantially negatively altered or eliminated, or if a substantial
portion of our claims for tax credits were denied by the relevant taxing authorities, pursuant to an audit or otherwise, it would have a
material adverse effect upon our financial results.
Risks related to our Industry
Generic drug manufacturers will increase competition for certain products and may reduce our expected royalties.
Part of our product development strategy includes making NDA filings relating to product candidates involving the novel reformulation of
existing drugs with active ingredients that are off-patent. Such NDA product candidates, if approved, are likely to face competition from
generic versions of such drugs in the future. Regulatory approval for generic drugs may be obtained without investing in costly and time
consuming clinical trials. Because of substantially reduced development costs, manufacturers of generic drugs are often able to charge
much lower prices for their products than the original developer of a new product. If we face competition from manufacturers of generic
drugs on products we may commercialize, such as our once-daily RexistaTM oxycodone product, the prices at which such of our products
are sold and the revenues we may receive could be reduced.
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Market acceptance of our products will be limited if users of our products are unable to obtain adequate reimbursement from
third-party payers.
Government health administration authorities, private health insurers and other organizations generally provide reimbursement for products
like ours, and our commercial success will depend in part on whether appropriate reimbursement levels for the cost of our products and
related treatments are obtained from government authorities, private health insurers and other organizations, such as health maintenance
organizations and managed care organizations. Even if we succeed in bringing any of our products to market, third-party payers may not
provide reimbursement in whole or in part for their use.
Significant uncertainty exists as to the reimbursement status of newly approved health care products. Some of our product candidates, such
as our once-daily RexistaTM abuse-deterrent oxycodone product, are intended to replace or alter existing therapies or procedures. These
third-party payers may conclude that our products are less safe, less effective or less economical than those existing therapies or
procedures. Therefore, third-party payers may not approve our products for reimbursement. We may be required to make substantial
pricing concessions in order to gain access to the formularies of large managed-care organizations. If third party payers do not approve our
products for reimbursement or fail to reimburse them adequately, sales will suffer as some physicians or their patients may opt for a
competing product that is approved for reimbursement or is adequately reimbursed. Even if third-party payers make reimbursement
available, these payers’ reimbursement policies may adversely affect our ability and our potential marketing and distribution partners’
ability to sell our products on a profitable basis.
We are subject to significant costs and uncertainties related to compliance with the extensive regulations that govern the
manufacturing, labeling, distribution, and promotion of pharmaceutical products as well as environmental, safety and health
regulations.
Governmental authorities in the United States and Canada regulate the research and development, testing and safety of pharmaceutical
products. The regulations applicable to our existing and future products may change. Regulations require extensive clinical trials and other
testing and government review and final approval before we can market our products. The cost of complying with government regulation
can be substantial and may exceed our available resources, causing delay or cancellation of our product introductions.
Some abbreviated application procedures for controlled-release drugs and other products, including those related to our ANDA filings, or to
the ANDA filings of unrelated third parties in respect of drugs similar to or chemically related to those of our ANDA filings, are or may
become the subject of petitions filed by brand-name drug manufacturers or other ANDA filers seeking changes from the FDA in the
interpretation of the statutory approval requirements for particular drugs as part of their strategy to thwart or advance generic competition.
We cannot predict whether the FDA will make any changes to its interpretation of the requirements applicable to our ANDA applications
as a result of these petitions, or whether unforeseen delays will occur in our ANDA filings while the FDA considers such petitions or
changes or otherwise, or the effect that any changes may have on us. Any such changes in FDA interpretation of the statutes or regulations,
or any legislated changes in the statutes or regulations, may make it more difficult for us to file ANDAs or obtain further approval of our
ANDAs and generate revenues and thus may materially harm our business and financial results.
Any failure or delay in obtaining regulatory approvals could make it so that we are unable to market any products we develop and therefore
adversely affect our business, results of operations, financial condition and cash flows. Even if product candidates are approved in the
United States or Canada, regulatory authorities in other countries must approve a product prior to the commencement of marketing the
product in those countries. The time required to obtain any such approval may be longer than in the United States or Canada, which could
cause the introduction of our products in other countries to be cancelled or materially delayed.
The manufacturing, distribution, processing, formulation, packaging, labeling and advertising of our products are subject to extensive
regulation by federal agencies, including in the United States, the FDA, Drug Enforcement Administration, Federal Trade Commission,
Consumer Product Safety Commission and Environmental Protection Agency, among others. We are also subject to state and local laws,
regulations and agencies. Compliance with these regulations requires substantial expenditures of time, money and effort in such areas as
production and quality control to ensure full technical compliance. Failure to comply with FDA and other governmental regulations can
result in fines, disgorgement, unanticipated compliance expenditures, recall or seizure of products, total or partial
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suspension of production or distribution, suspension of the FDA’s review of NDAs or ANDAs, enforcement actions, injunctions and civil
or criminal prosecution.
Environmental laws have changed in recent years and we may become subject to stricter environmental standards in the future and face
larger capital expenditures in order to comply with environmental laws. We are subject to extensive federal, state, provincial and local
environmental laws and regulations which govern the discharge, emission, storage, handling and disposal of a variety of substances that
may be used in, or result from, our operations. We are also subject periodically to environmental compliance reviews by environmental,
safety, and health regulatory agencies and to potential liability for the remediation of contamination associated with both present and past
hazardous waste generation, handling, and disposal activities. We cannot accurately predict the outcome or timing of future expenditures
that we may be required to make in order to comply with the federal, state, local and provincial environmental, safety, and health laws and
regulations that are applicable to our operations and facilities.
We are subject to product liability costs for which we may not have or be able to obtain adequate insurance coverage.
The testing and marketing of pharmaceutical products entails an inherent risk of product liability. Liability exposures for pharmaceutical
products can be extremely large and pose a material risk. In some instances, we may be or may become contractually obligated to
indemnify third parties for such liability. Our business may be materially and adversely affected by a successful product liability claim or
claims in excess of any insurance coverage that we may have. Further, even if claims are not successful, the costs of defending such claims
and potential adverse publicity could be harmful to our business.
While we currently have, and in some cases are contractually obligated to maintain, insurance for our business, property and our products
as they are administered in bioavailability/bioequivalence studies, first and third party insurance is increasingly costly and narrow in scope.
Therefore, we may be unable to meet such contractual obligations or we may be required to assume more risk in the future. If we are
subject to third party claims or suffer a loss or damage in excess of our insurance coverage, we may be required to bear that risk in excess of
our insurance limits. Furthermore, any first or third party claims made on our insurance policy may impact our ability to obtain or maintain
insurance coverage at reasonable costs or at all in the future.
Our products involve the use of hazardous materials and waste, and as a result we are exposed to potential liability claims and to
costs associated with complying with laws regulating hazardous waste.
Our research and development activities involve the use of hazardous materials, including chemicals, and are subject to Canadian federal,
provincial and local laws and regulations governing the use, manufacture, storage, handling and disposal of hazardous materials and waste
products. It is possible that accidental injury or contamination from these materials may occur. In the event of an accident, we could be
held liable for any damages, which could exceed our available financial resources. Further, we may not be able to maintain insurance to
cover these costs on acceptable terms, or at all. In addition, we may be required to incur significant costs to comply with environmental
laws and regulations in the future.
Our operations may be adversely affected by risks associated with international business.
We may be subject to certain risks that are inherent in an international business, including:
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varying regulatory restrictions on sales of our products to certain markets and unexpected changes in regulatory requirements;
tariffs, customs, duties, and other trade barriers;
difficulties in managing foreign operations and foreign distribution partners;
longer payment cycles and problems in collecting accounts receivable;
political risks;
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foreign exchange controls that may restrict or prohibit repatriation of funds;
export and import restrictions or prohibitions, and delays from customs brokers or government agencies;
seasonal reductions in business activity in certain parts of the world; and
potentially adverse tax consequences.
Depending on the countries involved, any or all of the foregoing factors could materially harm our business, financial condition and results
of operations.
Risks related to our common shares
Our share price has been highly volatile and our shares could suffer a further decline in value.
The trading price of our common shares has been highly volatile and could continue to be subject to wide fluctuations in price in response
to various factors, many of which are beyond our control, including:
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sales of our common shares, including any sales made in connection with future financings;
announcements regarding new or existing corporate relationships or arrangements;
announcements by us of significant acquisitions, joint ventures, or capital commitments;
actual or anticipated period-to-period fluctuations in financial results;
clinical and regulatory development regarding our product candidates;
litigation or threat of litigation;
failure to achieve, or changes in, financial estimates by securities analysts;
comments or opinions by securities analysts or members of the medical community;
announcements regarding new or existing products or services or technological innovations by us or our competitors;
conditions or trends in the pharmaceutical and biotechnology industries;
additions or departures of key personnel or directors;
economic and other external factors or disasters or crises;
limited daily trading volume; and
developments regarding our patents or other intellectual property or that of our competitors.
In addition, the stock market in general and the market for drug development companies in particular have experienced significant price and
volume fluctuations that have often been unrelated or disproportionate to the operating performance of those companies. Further, there has
been significant volatility in the market prices of securities of life science companies. In the past, following periods of volatility in the
market price of a company’s securities, securities class action litigation has often been instituted. A securities class action suit against us
could result in substantial costs, potential liabilities, and the diversion of management’s attention and resources.
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A large number of our common shares could be sold in the market in the near future, which could depress our stock price.
As of the date of this annual report, we had approximately 23.5 million common shares outstanding. In addition, a substantial portion of our
shares are currently freely trading without restriction under the Securities Act of 1933, as amended (“U.S. Securities Act”), having been
registered for resale or held by their holders for over one year and are eligible for sale under Rule 144. In addition, in November 2013, we
established an at-the-market equity program pursuant to which we could sell up to 5,305,484 of our common shares for up to an aggregate
of $16.8 million (or such lesser amount as may be permitted under applicable securities laws and regulations). As of the date of this annual
report we have issued and sold 1,689,500 common shares with an aggregate offering price of $6,571,673 under the at-the-market program.
As a result, we may offer and sell our common shares with an aggregate purchase price of up to $10,228,327 pursuant to the at-the-market
program. Roth Capital Partners, LLC (“Roth”) received compensation of $181,003 in connection with such sales.
On June 4, 2014, the Company’s most recent registration statement on Form F-3 was declared effective by the United States Securities and
Exchange Commission (“SEC”) (the “Shelf Registration Statement”), and on June 5, 2014, the Company filed a final short form base
shelf prospectus with securities regulatory authorities in each of the provinces and territories of Canada, except Quebec. These documents
allow for, subject to securities regulatory requirements and limitations, the potential offering of up to an aggregate of US$100 million of the
Company's common shares, preference shares, warrants, subscription receipts and units, or any combination thereof, from time to time in
one or more offerings, and are intended to give the Company the flexibility to take advantage of financing opportunities when, and if,
market conditions are favorable to the Company. The specific terms of such future offerings, if any, would be established, subject to the
approval of the Company's board of directors, at the time of such offering and will be described in detail in a prospectus supplement filed at
the time of any such offering. To the extent any securities of the Company are issued by the Company under the Shelf Registration
Statement or the shelf prospectus, a shareholder’s percentage ownership will be diluted and our stock price could be further adversely
affected. As of the date of this annual report, the Company has not sold any securities under the Shelf Registration Statement or the shelf
prospectus and there can be no assurance that any securities will be sold under the Shelf Registration Statement or the shelf prospectus.
On October 22, 2009, IntelliPharmaCeutics Ltd. (“IPC Ltd.”) and Vasogen Inc. (“Vasogen”) completed a plan of arrangement and merger
(the “IPC Arrangement Agreement ”), resulting in the formation of the Company. Our shareholders who received shares under the IPC
Arrangement Agreement who were not deemed “affiliates” of either Vasogen, IPC Ltd. or us prior to the IPC Arrangement Agreement were
able to resell the common shares that they received without restriction under the U.S. Securities Act. The common shares received by an
“affiliate” after the IPC Arrangement Agreement or who were “affiliates” of either Vasogen, IPC Ltd. or us prior to the IPC Arrangement
Agreement are subject to certain restrictions on resale under Rule 144.
As of the date of this annual report, there are currently common shares issuable upon the exercise of outstanding options and warrants and
the conversion of an outstanding convertible debenture for an aggregate of approximately 7.6 million common shares. To the extent any of
our options and warrants are exercised and the convertible debenture is converted, a shareholder’s percentage ownership will be diluted and
our stock price could be further adversely affected. Moreover, as the underlying shares are sold, the market price could drop significantly if
the holders of these restricted shares sell them or if the market perceives that the holders intend to sell these shares.
We have no history or foreseeable prospect of paying cash dividends.
We have not paid any cash dividends on our common shares and do not intend to pay cash dividends in the foreseeable future. We intend to
retain future earnings, if any, for reinvestment in the development and expansion of our business. Dividend payments in the future may also
be limited by loan agreements or covenants contained in other securities we may issue. Any future determination to pay cash dividends will
be at the discretion of our board of directors and depend on our financial condition, results of operations, capital and legal requirements and
such other factors as our board of directors deems relevant.
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There may not be an active, liquid market for our common shares.
There is no guarantee that an active trading market for our common shares will be maintained on the NASDAQ Capital Market
(“NASDAQ”) or the Toronto Stock Exchange (“TSX”). Investors may not be able to sell their shares quickly or at the latest market price if
trading in our common shares is not active.
Future issuances of our shares could adversely affect the trading price of our common shares and could result in substantial
dilution to shareholders.
We may need to issue substantial amounts of common shares in the future. In this regard, in November 2013, we entered into an at-the-
market program pursuant to which we may, from time to time, sell up to 5,305,484 of our common shares for up to an aggregate of $16.8
million (or such lesser amount as may be permitted under applicable securities laws and regulations) of our common shares on NASDAQ or
otherwise. As of the date of this annual report, we have issued and sold 1,689,500 common shares with an aggregate offering price of
$6,571,673 under the at-the-market program. As a result, we may offer and sell our common shares with an aggregate purchase price of up
to $10,228,327 pursuant to the at-the-market program. There can be no assurance that any additional shares will be sold under our at-the-
market program. To the extent that the market price of our common shares declines, we will need to issue an increasing number of common
shares per dollar of equity investment. In addition to our common shares issuable in connection with the exercise of our outstanding
warrants, our employees, and directors will hold rights to acquire substantial amounts of our common shares. In order to obtain future
financing if required, it is likely that we will issue additional common shares or financial instruments that are exchangeable for or
convertible into common shares. Also, in order to provide incentives to employees and induce prospective employees and consultants to
work for us, we may offer and issue options to purchase common shares and/or rights exchangeable for or convertible into common shares.
Future issuances of shares could result in substantial dilution to shareholders. Capital raising activities, if available, and dilution associated
with such activities could cause our share price to decline. In addition, the existence of common share purchase warrants may encourage
short selling by market participants. Also, in order to provide incentives to current employees and directors and induce prospective
employees and consultants to work for us, we have historically granted options and deferred share units (“DSUs”), and intend to continue to
do so or offer and issue other rights exchangeable for or convertible into common shares. Future issuances of shares could result in
substantial dilution to all our shareholders. In addition, future public sales by holders of our common shares could impair our ability to raise
capital through any future equity offerings.
On June 4, 2014, the Shelf Registration Statement was declared effective by the SEC and on June 5, 2014, the Company filed a final short
form base shelf prospectus with securities regulatory authorities in each of the provinces and territories of Canada, except Quebec. These
documents allow for, subject to securities regulatory requirements and limitations, the potential offering of up to an aggregate of US$100
million of the Company's common shares, preference shares, warrants, subscription receipts and units, or any combination thereof, from
time to time in one or more offerings, and are intended to give the Company the flexibility to take advantage of financing opportunities
when, and if, market conditions are favorable to the Company. The specific terms of such future offerings, if any, would be established,
subject to the approval of the Company's board of directors, at the time of such offering and will be described in detail in a prospectus
supplement filed at the time of any such offering. As of the date of this annual report, the Company has not sold any securities under the
Shelf Registration Statement or the shelf prospectus and there can be no assurance that any securities will be sold under the shelf
prospectus.
We may in the future issue preference shares which could adversely affect the rights of holders of our common shares and the
value of such shares.
Our board of directors has the ability to authorize the issue of an unlimited number of preference shares in series, and to determine the
price, rights, preferences and privileges of those shares without any further vote or action by the holders of our common shares. Although
we have no preference shares issued and outstanding, preference shares issued in the future could adversely affect the rights and interests of
holders of our common shares.
Our common shares may not continue to be listed on the TSX.
Failure to maintain the applicable continued listing requirements of the TSX could result in our common shares being delisted from the
TSX. The TSX will normally consider the delisting of securities if, in the opinion of the exchange, it appears that the public distribution,
price, or trading activity of the securities has been so reduced as to
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make further dealings in the securities on TSX unwarranted. Specifically, participating securities may be delisted from the TSX if, among
other things, the market value of an issuer’s securities is less than C$3,000,000 over any period of 30 consecutive trading days. In such
circumstances, the TSX may place an issuer under a delisting review pursuant to which the issuer would be reviewed under the TSX’s
remedial review process and typically be granted 120 days to comply with all requirements for continued listing. If the market price of our
common shares declines further or we are unable to maintain other listing requirements, the TSX could commence a remedial review
process that could lead to the delisting of our common shares from the TSX. Further, if we complete a sale, merger, acquisition, or
alternative strategic transaction, we will have to consider if the continued listing of our common shares on the TSX is appropriate, or
possible.
If our common shares are no longer listed on the TSX, they may be eligible for listing on the TSX Venture Exchange. In the event that we
are not able to maintain a listing for our common shares on the TSX or the TSX Venture Exchange, it may be extremely difficult or
impossible for shareholders to sell their common shares in Canada. Moreover, if we are delisted from the TSX, but obtain a substitute
listing for our common shares on the TSX Venture Exchange, our common shares will likely have less liquidity and more price volatility
than experienced on the TSX.
Shareholders may not be able to sell their common shares on any such substitute exchange in the quantities, at the times, or at the prices
that could potentially be available on a more liquid trading market. As a result of these factors, if our common shares are delisted from the
TSX, the price of our common shares is likely to decline.
Our common shares may not continue to be listed on NASDAQ.
Failure to meet the applicable quantitative and/or qualitative maintenance requirements of NASDAQ could result in our common shares
being delisted from NASDAQ. For continued listing, NASDAQ requires, among other things, that listed securities maintain a minimum bid
price of not less than $1.00 per share. If the bid price falls below the $1.00 minimum for more than 30 consecutive trading days, an issuer
will typically have 180 days to satisfy the $1.00 minimum bid price, which must be maintained for a period of at least ten trading days in
order to regain compliance.
If we are delisted from NASDAQ, our common shares may be eligible for trading on an over-the-counter market in the United States. In
the event that we are not able to obtain a listing on another U.S. stock exchange or quotation service for our common shares, it may be
extremely difficult or impossible for shareholders to sell their common shares in the United States. Moreover, if we are delisted from
NASDAQ, but obtain a substitute listing for our common shares in the United States, it will likely be on a market with less liquidity, and
therefore potentially more price volatility, than NASDAQ. Shareholders may not be able to sell their common shares on any such substitute
U.S. market in the quantities, at the times, or at the prices that could potentially be available on a more liquid trading market. As a result of
these factors, if our common shares are delisted from NASDAQ, the price of our common shares is likely to decline. In addition, a decline
in the price of our common shares will impair our ability to obtain financing in the future.
Our common shares are listed for trading in the United States and may become subject to the Securities and Exchange
Commission’s penny stock rules.
Transactions in securities that are traded in the United States by companies with net tangible assets of $5,000,000 or less and a market price
per share of less than $5.00 that are not traded on NASDAQ or on other securities exchanges may be subject to the “penny stock” rules
promulgated under the Securities Exchange Act of 1934, as amended (“U.S. Exchange Act”). Under these rules, broker-dealers who
recommend such securities to persons other than institutional investors must:
• make a special written suitability determination for the purchaser;
•
•
receive the purchaser’s written agreement to a transaction prior to sale;
provide the purchaser with risk disclosure documents which identify risks associated with investing in “penny stocks” and which
describe the market for these “penny stocks” as well as a purchaser’s legal remedies; and
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•
obtain a signed and dated acknowledgment from the purchaser demonstrating that the purchaser has actually received the required
risk disclosure document before a transaction in a “penny stock” can be completed.
As a result of these requirements, if our common shares are at such time subject to the “penny stock” rules, broker-dealers may find it
difficult to effectuate customer transactions and trading activity in these shares in the United States may be significantly limited.
Accordingly, the market price of the shares may be depressed, and investors may find it more difficult to sell the shares.
As a foreign private issuer in the United States, we are subject to different U.S. securities laws and rules than a domestic U.S.
issuer.
As a foreign private issuer under U.S. securities laws we are not required to comply with all the periodic disclosure requirements of the U.S.
Exchange Act applicable to domestic United States companies and therefore the publicly available information about us may be different or
more limited than if we were a United States domestic issuer. In addition, our officers, directors, and principal shareholders are exempt
from the “real time” reporting and “short swing” profit recovery provisions of Section 16 of the U.S. Exchange Act and the rules
thereunder. Although under Canadian rules, our officers, directors and principal shareholders are generally required to file on SEDI
(www.sedi.ca) reports of transactions involving our common shares within five calendar days of such transaction, our shareholders may not
know when our officers, directors and principal shareholders purchase or sell our common shares as timely as they would if we were a
United States domestic issuer.
We are exposed to risks if we are unable to comply with laws and future changes to laws affecting public companies, including the
Sarbanes-Oxley Act of 2002, and also to increased costs associated with complying with such laws.
Any future changes to the laws and regulations affecting public companies, as well as compliance with existing provisions of the Sarbanes-
Oxley Act of 2002 (“SOX”) in the United States and applicable Canadian securities laws, regulations, rules and policies, may cause us to
incur increased costs to comply with such laws and requirements, including, among others, hiring additional personnel and increased legal,
accounting and advisory fees. Delays, or a failure to comply with applicable laws, rules and regulations could result in enforcement actions,
the assessment of other penalties and civil suits. The new laws and regulations may increase potential costs to be borne under indemnities
provided by us to our officers and directors and may make it more difficult to obtain certain types of insurance, including liability insurance
for directors and officers; as such, we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to
obtain the same or similar coverage. The impact of these events could also make it more difficult to attract and retain qualified persons to
serve on our board of directors, or as executive officers.
We are required annually to review and report on the effectiveness of our internal control over financial reporting in accordance with SOX
Section 404 and Multilateral Instrument 52-109 – Certification of Disclosure in Issuer’s Annual and Interim Filings of the Canadian
Securities Administrators. The results of this review are reported in our Annual Report on Form 20-F and in our Management Discussion
and Analysis.
Management’s review is designed to provide reasonable, not absolute, assurance that all material weaknesses in our internal controls are
identified. Material weaknesses represent deficiencies in our internal controls that may not prevent or detect a misstatement occurring
which could have a material adverse effect on our quarterly or annual financial statements. In addition, there can be no assurance that any
remedial actions we take to address any material weaknesses identified will be successful, nor can there be any assurance that further
material weaknesses will not be identified in future years. Material errors, omissions or misrepresentations in our disclosures that occur as a
result of our failure to maintain effective internal control over financial reporting could have a material adverse effect on our business,
financial condition, results of operations, and the value of our common shares.
We may be classified as a “passive foreign investment company” or “PFIC” for U.S. income tax purposes, which could have
significant and adverse tax consequences to U.S. investors.
The possible classification of our company as a passive foreign investment company (“PFIC”) for U.S. federal income tax purposes could
have significant and adverse tax consequences for U.S. Holders (as defined in Item 10
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below) of our common shares and preference shares (collectively, “shares”). It may be possible for U.S. holders of shares to mitigate
certain of these consequences by making an election to treat us as a “qualified electing fund” or “QEF” under Section 1295 of the Code (a
“QEF Election”) or a mark-to-market election under Section 1296 of the Internal Revenue Code of 1986, as amended (the “Code”). A non-
U.S. corporation generally will be a PFIC if, for a taxable year (a) 75% or more of the gross income of such corporation for such taxable
year consists of specified types of passive income or (b) on average, 50% or more of the assets held by such corporation either produce
passive income or are held for the production of passive income, based on the fair market value of such assets (or on the adjusted tax basis
of such assets, if such non-U.S. corporation is not publicly traded and either is a “controlled foreign corporation” under Section 957(a) of
the Code, or makes an election to determine whether it is a PFIC based on the adjusted basis of the assets).
The determination of whether we are, or will be, a PFIC for a taxable year depends, in part, on the application of complex U.S. federal
income tax rules, which are subject to various interpretations. Although the matter is not free from doubt, we believe that we were not a
PFIC during our 2014 taxable year and will not likely be a PFIC during our 2015 taxable year. Because PFIC status is based on our income,
assets and activities for the entire taxable year, and our market capitalization, it is not possible to determine whether we will be
characterized as a PFIC for the 2015 taxable year until after the close of the taxable year. The tests for determining PFIC status are subject
to a number of uncertainties. These tests are applied annually, and it is difficult to accurately predict future income, assets and activities
relevant to this determination. In addition, because the market price of our common shares is likely to fluctuate, the market price may affect
the determination of whether we will be considered a PFIC. There can be no assurance that we will not be considered a PFIC for any
taxable year (including our 2015 taxable year). Absent one of the elections described above, if we are a PFIC for any taxable year during
which a U.S. holder holds our shares, we generally will continue to be treated as a PFIC regardless of whether we cease to meet the PFIC
tests in one or more subsequent years. Accordingly, no assurance can be given that we will not constitute a PFIC in the current (or any
future) tax year or that the Internal Revenue Service (the “IRS”) will not challenge any determination made by us concerning our PFIC
status.
If we are a PFIC, the U.S. federal income tax consequences to a U.S. holder of the ownership and disposition of our shares will depend on
whether such U.S. holder makes a QEF or mark-to-market election. Unless otherwise provided by the IRS, a U.S. holder of our shares is
generally required to file an informational return annually to report its ownership interest in the Company during any year in which we are a
PFIC.
The foregoing does not purport to be a complete enumeration or explanation of the tax risks involved in an investment in our
company. Prospective investors should read this entire annual report and consult with their own legal, tax and financial advisors
before deciding to invest in our company.
It may be difficult to obtain and enforce judgments against us because of our Canadian residency.
We are governed by the laws of Canada. Most of our directors and officers are residents of Canada or other jurisdictions outside of the
United States and all or a substantial portion of our assets and the assets of such persons may be located outside of the United States. As a
result, it may be difficult for shareholders to effect service of process upon us or such persons within the United States or to realize in the
United States on judgments of courts of the United States predicated upon the civil liability provisions of the U.S. federal securities laws or
other laws of the United States. In addition, there is doubt as to the enforceability in Canada of liabilities predicated solely upon U.S.
federal securities law against us, our directors, controlling persons and officers who are not residents of the United States, in original
actions or in actions for enforcements of judgments of U.S. courts.
Item 4.
Information on the Company
A.
History and Development of the Company
The Company was incorporated under the Canada Business Corporations Act by certificate and articles of arrangement dated
October 22, 2009.
Our registered principal office is located at 30 Worcester Road, Toronto, Ontario, Canada M9W 5X2. Our telephone number is
(416) 798-3001 and our facsimile number is (416) 798-3007.
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Our agent for service in the United States is Corporation Service Company at 1090 Vermont Avenue N.W., Washington, D.C.
20005.
On October 19, 2009, the shareholders of IPC Ltd. and Vasogen approved the IPC Arrangement Agreement that resulted in the
October 22, 2009 court-approved merger of IPC Ltd. and another U.S. subsidiary of Intellipharmaceutics Inc., coincident with an
arrangement pursuant to which a predecessor of the Company combined with 7231971 Canada Inc., a new Vasogen company that acquired
substantially all of the assets and certain liabilities of Vasogen, including the proceeds from its non-dilutive financing transaction with
Cervus LP (the “IPC Arrangement Transaction ”). The completion of the IPC Arrangement Transaction on October 22, 2009 resulted in
the formation of the Company, which is incorporated under the laws of Canada. The common shares of the Company are traded on the
TSX and NASDAQ.
For the years ended November 30, 2014, 2013 and 2012, we spent a total of $8,020,201, $5,076,236, and $5,992,417, respectively,
on research and development. Over the past three fiscal years and up to February 23, 2014, we have raised approximately $19,268,473 in
gross proceeds from the issuance of equity and convertible debt securities. Our common shares are listed on the TSX under the symbol “I”
and on NASDAQ under the symbol “IPCI”.
During the last and current financial year, we have not been aware of any indications of public takeover offers by third parties in
respect of the Company’s shares or by the Company in respect of other companies’ shares.
For additional information on key events, see Item 4.B below.
B.
Business Overview
We are a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-
release and targeted-release oral solid dosage drugs. Our patented HypermatrixTM technology is a multidimensional controlled-release drug
delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this
technology platform, we have developed several drug delivery systems and a pipeline of products (our dexmethylphenidate hydrochloride
extended-release capsules for the 15 and 30 mg strengths which received final FDA approval) and product candidates in various stages of
development, including ANDAs filed with the FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract
(“GIT”), diabetes and pain.
We received final approval from the FDA in November 2013 to launch the 15 mg and 30 mg strengths of our generic Focalin
XR® (dexmethylphenidate hydrochloride extended-release) capsules. Commercial sales of these strengths were launched immediately by
our commercialization partner in the United States, Par. As the first-filer for the drug product in the 15 mg strength, we had 180 days (up to
May 19, 2014) of exclusivity of sales for the generic product of that strength from the date of launch on November 19, 2013 in the United
States by our partner, Par. In fiscal 2014 we recognized licensing revenue of approximately $8.4 million in respect of the Par agreement,
compared to approximately $1.5 million in fiscal 2013. The increase in 2014 reflects a full year of profit sharing under the license and
commercialization agreement with Par (the “Par agreement”), as opposed to a late launch in the previous year (November 19, 2013).
Our 5, 10, 20 and 40 mg strengths were also tentatively FDA approved, subject to the right of another party or parties to 180 days
of generic exclusivity from the date of first launch of such products by such parties. We believe that Teva Pharmaceuticals USA, Inc.
(“Teva”) launched their own 5 mg strength of generic Focalin XR® capsules on November 11, 2014. We believe that Par intends to launch
the 5mg strength in May 2015 upon the expiry of the exclusivity period, but there can be no assurance as to when or if the launch will
occur. There can be no assurance as to when or if final FDA approval will be received for the remaining product strengths we have applied
for or that any of these strengths tentatively approved will ever be successfully commercialized.
On February 2, 2015 we announced that we entered into an agreement with Teva by which we have granted Teva an exclusive
license to market in the United States an extended release drug product candidate for which we have an ANDA pending FDA approval.
Under the agreement with Teva, subject to certain conditions, we have agreed to manufacture and supply the product exclusively for Teva
and Teva has agreed that we will be its sole supplier of the product to be marketed in the U.S. There can be no assurance as to when or if
the product will be
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approved by the FDA or that, if so approved, it will be successfully commercialized and produce significant revenue for us.
Our goal is to leverage our proprietary technologies and know-how in order to build a diversified portfolio of commercialized
products that generate revenue. We intend to do this by advancing our products from the formulation stage through product development,
regulatory approval and manufacturing. We believe that full integration of development and manufacturing will help maximize the value of
our drug delivery technologies, products and product candidates. We also believe that out-licensing sales and marketing to established
organizations, when it makes economic sense to do so, will improve our return from our products while allowing us to focus on our core
competencies. We expect expenditures in investing activities for the purchase of production equipment and the expansion of manufacturing
and warehousing capability to be higher as we prepare for the commercialization of ANDAs that are pending FDA approval.
Our Strategy
We believe that our Hypermatrix TM technologies are a multidimensional controlled-release drug delivery platform that can be
applied to the efficient development of a wide range of existing and new pharmaceuticals. We believe that the flexibility of these
technologies allows us to develop complex drug delivery solutions within an industry-competitive timeframe. Based on this technology
platform, we have developed several drug delivery systems and a pipeline of products (our generic Focalin XR® (dexmethylphenidate
hydrochloride extended-release) capsules for the 15 mg and 30 mg strengths which received final FDA approval) and product candidates in
various stages of development, including ANDAs filed with the FDA. Certain, but not all, of the products in our pipeline may be developed
from time to time for third parties pursuant to drug development agreements with those third parties, under which our development partner
generally pays certain of the expenses of development, sometimes makes certain milestone payments to us and receives a share of revenues
or profits if the drug is developed successfully to completion, the control of which is generally in the discretion of our drug development
partner.
The HypermatrixTM technologies are applied to the development of both existing and new pharmaceuticals across a range of
therapeutic classes. The competitive advantages of these technologies allow us to focus our development activities in two areas; difficult-
to-develop controlled-release generic drugs, which follow an ANDA regulatory path; and improved current therapies through controlled
release, which follow a new drug application (“NDA”) 505(b)(2) regulatory path.
The market we operate in is created by the expiration of drug product patents, challengeable patents and drug product exclusivity periods.
There are three ways that we employ our controlled-release technologies, which we believe represent substantial opportunities for us to
commercialize on our own or develop products or out-license our technologies and products:
•
•
For existing controlled-release (once-a-day) products whose APIs are covered by drug molecule patents about to expire or already
expired, or whose formulations are covered by patents about to expire, already expired or which we believe we do not infringe, we
can seek to formulate generic products which are bioequivalent to the branded products. Our scientists have demonstrated a
successful track record with such products, having previously developed several drug products which have been commercialized in
the United States by their former employer/clients. The regulatory pathway for this approach requires ANDAs for the United States
and corresponding pathways for other jurisdictions.
For branded immediate-release (multiple-times-per-day) drugs, we can formulate improved replacement products, typically by
developing new, potentially patentable, controlled-release once-a-day drugs. Among other out-licensing opportunities, these drugs
can be licensed to and sold by the pharmaceutical company that made the original immediate-release product. These can potentially
protect against revenue erosion in the brand by providing a clinically attractive patented product that competes favorably with the
generic immediate-release competition that arises on expiry of the original patent(s). The regulatory pathway for this approach
requires NDAs via a 505(b)(2) application for the U.S. or corresponding pathways for other jurisdictions where applicable. The
505(b)(2) pathway (which relies in part upon the approving agency’s findings for a previously approved drug) both accelerates
development timelines and reduces costs in comparison to NDAs for new chemical entities.
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•
Some of our technologies are also focused on the development of abuse-deterrent pain medications. The growing abuse and
diversion of prescription “painkillers”, specifically opioid analgesics, is well documented and is a major health and social concern.
We believe that our technologies and know-how are aptly suited to developing abuse-deterrent pain medications. The regulatory
pathway for this approach requires NDAs via a 505(b)(2) application for the U.S. or corresponding pathways for other jurisdictions
where applicable.
We intend to collaborate in the development and/or marketing of one or more products with partners, when we believe that such
collaboration may enhance the outcome of the project. We also plan to seek additional collaborations as a means of developing additional
products. We believe that our business strategy enables us to reduce our risk by (a) having a diverse product portfolio that includes both
branded and generic products in various therapeutic categories, and (b) building collaborations and establishing licensing agreements with
companies with greater resources thereby allowing us to share costs of development and to improve cash-flow. There can be no assurance
that we will be able to enter into additional collaborations or, if we do, that such arrangements will be beneficial.
Our Drug Delivery Technologies
Our scientists have developed drug delivery technology systems, based on the HypermatrixTM platform, that facilitate controlled-
release delivery of a wide range of pharmaceuticals. These systems include several core technologies, which enable us to flexibly respond
to a wide range of drug attributes and patient requirements, producing a desired controlled-release effect. Our technologies have been
incorporated in drugs manufactured and sold by major pharmaceutical companies.
This group of drug delivery technology systems is based upon the drug active ingredient (“drug active”) being imbedded in, and
an integral part of, a homogeneous (uniform), core and/or coatings consisting of one or more polymers which affect the release rates of
drugs, other excipients (compounds other than the drug active), such as for instance lubricants which control handling properties of the
matrix during fabrication, and the drug active itself. The HypermatrixTM technologies are the core of our current marketing efforts and the
technologies underlying our existing development agreements.
Our platform of HypermatrixTM drug delivery technologies include, but are not limited to, IntelliFoamTM, IntelliGITransporterTM,
IntelliMatrixTM, IntelliOsmoticsTM, IntelliPasteTM, IntelliPelletsTM, IntelliShuttleTM and nPODDDSTM. Some of their key attributes are
described below.
These technologies provide a broad range of release profiles, taking into account the physical and chemical characteristics of a
drug product, the therapeutic use of the particular drug, and the optimal site for release of the API in the GIT. At present those technologies
have been applied in the laboratory and/or in bioavailability/bioequivalence studies in man to such orally administered small molecule
drugs as are used in the treatment of neurological, cardiovascular, GIT, diabetes, pain and other significant indications.
The HypermatrixTM Family of Technologies
IntelliFoamTM
The IntelliFoamTM technology is based on the drug active being embedded in, but separate from a syntactic foam substrate, the
properties of which are used to modulate the release of the drug active. The drug actives are embedded in a resin polymer matrix.
IntelliGITransporterTM
The IntelliGITransporterTM technology consists of an active drug immobilized in a homogeneous (uniform) matrix structure. A
precise choice of mix ratios, polymers, and other ingredients imparts characteristics which protect the drug composition from mechanical
degradation due to digestion, and/or from chemical degradation in the acidic stomach environment, and ensures that this technology allows
control of release as well as releasing the medication at certain parts of the stomach or intestines without significant food effects or
unintentional premature release of the entire drug dose. We believe that this technology is most useful for drug molecules with
characteristics
-25-
such as very low or very high potency, opiate analgesics (pain medications derived from the chemical compounds found in opium), or
susceptibility to acid degradation. It is also useful for products where a zero-order (constant rate over time, independent of the amount of
drug available for dissolution) release profile is desirable.
IntelliMatrixTM
The IntelliMatrixTM technology is a proprietary blend of several polymers. Depending on the constituents of the blend and the
manner in which these interact, the use of the blend with a drug allows the drug to be released at predetermined rates, while imparting
protective characteristics to both the drug and the GIT. This is most useful for drugs which require precisely controlled first-order release
profiles, where the amount released with time is dependent on one component like the amount of drug available for dissolution.
IntelliOsmoticsTM
The IntelliOsmoticsTM technology is based upon the inclusion of multiple populations of polymers with distinct chemical bonding
characteristics. These set up a complex matrix of hydrophilic (water attracting) and hydrophobic (water repelling) domains. When the tablet
or bead is in an aqueous environment, like gastric contents, a “mixture” of water-soluble polymer and drug core is surrounded by gel
layer(s) of water-insoluble polymer. Osmotic pressure drives the drug out when solvent passes through the gel layer while the polymer
molecules remain. This permits control of the rate of release of the drug active by the variation of polymer ratios. This technology is most
useful for drug molecules which require precisely controlled pseudo-first-order release profiles, where the rate of release is proportional to
the amount available for dissolution as well as being proportional to one other component; however the effect of the amount of drug is
overriding, so that the rate appears first-order. This type of release control can be useful when attempting to match difficult profiles for
generic formulation.
IntelliPasteTM
The IntelliPasteTM technology is comprised of blends of multiple polymers, oils, excipients and drug active(s) which result in a
paste-in-a-capsule dosage form. The physical attributes of the paste include that it is thixotropic, pseudoplastic and non-Newtonian or, in
layman’s terms, like toothpaste. Typically, it is formulated as having very low solubility in water or oil, and low solubility in alcohol. These
characteristics enable the resulting drug product to have tamper-deterrent properties, and to resist dissolution in even high concentrations of
alcohol. As a result, IntelliPasteTM is the Company’s preferred delivery technology for the controlled delivery of opiates, narcotics and
other central nervous system drug products which are susceptible to unlawful diversion or abuse.
IntelliPelletsTM
The IntelliPelletsTM technology consists of one or more type (population) of granule, bead, pellet, or tablet in a holding chamber
or reservoir, such as a hard gelatin capsule. Each type (population) may be uniquely different from the other in the manner or rate it
releases the drug. Our IntelliPelletsTM technology is designed to control, prolong, delay or modify the release of drugs. It is particularly
useful for the delivery of multiple drugs, for delayed, timed, pulsed or for chronotherapeutic drug delivery, designed to mimic our internal
clocks for therapeutic optimization (the drug is delivered in the right amount for the patient at the right time). This technology is most
useful for the delivery of multiple-drug cocktails, or in situations where the timing of a single dose or the sequencing of multiple doses of
the same drug is important.
IntelliShuttleTM
The IntelliShuttleTM technology provides for drug release past the stomach, such as for drugs required for action beyond the
stomach, for drugs which could be destroyed by the stomach environment, or for drugs which could harm the stomach itself. This
technology “shuttles” the drug past the stomach to be released at predetermined times or sites where appropriate for optimum therapeutic
effect. This technology is most useful for acid labile drug molecules (drugs that are destroyed in acid environment), such as the proton
pump inhibitors, of which well-known omeprazole (Prilosec) and lansoprazole (Prevacid) are examples, or for drug molecules which may
harm the stomach, of which the well-known aspirin is an example.
-26-
Each of the above-noted proprietary technologies was fully developed and ready for application to client drug delivery
requirements from the date of our inception. Each of them has been utilized and applied to client drug delivery requirements under our
existing and previous development contracts; in several instances more than one technology has been applied to a single drug development.
We continue to develop all of our existing technologies and to conduct the necessary research to develop new products and technologies.
nPODDDSTM (novel point of divergence drug delivery system)
The technology platform in our formulation of Rexista™ oxycodone, the Point of Divergence Drug Delivery System
(“nPODDDSTM”), is designed to provide for certain unique drug delivery features in a product. These include the release of the active
substance to show a divergence in a dissolution and/or bioavailability profile. The divergence represents a point or a segment in a release
timeline where the release rate, represented by the slope of the curve, changes from an initial rate or set of rates to another rate or set of
rates, the former representing the usually higher rate of release shortly after ingesting a dose of the drug, and the latter representing the rate
of release over a later and longer period of time, being more in the nature of a controlled-release or sustained action. It is applicable for the
delivery of opioid analgesics in which it is desired to discourage common methods of tampering associated with misuse and abuse of a
drug, and also dose dumping in the presence of alcohol. It can potentially retard tampering without interfering with the bioavailability of
the product.
Our Products and Product Candidates
The table below shows the present status of our ANDA and NDA products and product candidates that have been disclosed to the
public.
Generic name
Brand
Indication
Stage of Development(1) Regulatory
Pathway
Focalin XR® Attention deficit
hyperactivity
disorder
Effexor XR® Depression
Dexmethylphenidate
hydrochloride
extended-release
capsules
Venlafaxine
hydrochloride
extended-release
capsules
Pantoprazole sodium
delayed- release tablets
Protonix®
Metformin
hydrochloride
extended-release tablets
Glucophage®
XR
Quetiapine fumarate
extended-release tablets
Seroquel XR® Schizophrenia,
Conditions
associated with
gastroesophageal
reflux disease
Management of
type 2 diabetes
bipolar disorder &
major depressive
disorder
Anti-convulsant
for epilepsy
Lamotrigine extended-
release tablets
Lamictal®
XRTM
Levetiracetam
extended-release tablets
Keppra XR® Partial onset
seizures for
epilepsy
Desvenlafaxine
extended-release tablets
Pristiq®
Depression
Received final approval for 15
and 30 mg, and tentative
approval for 5, 10, 20 and 40
mg, strengths from FDA
ANDA application for
commercialization approval
for 3 strengths under review
by FDA
ANDA application for
commercialization approval
for 2 strengths under review
by FDA
ANDA application for
commercialization approval
for 2 strengths under review
by FDA
ANDA application for
commercialization approval
for 5 strengths under review
by FDA
ANDA application for
commercialization approval
for 6 strengths under review
by FDA
ANDA application for
commercialization for 2
strengths under review by
FDA
ANDA application for
commercialization approval
for 2 strengths under review
by FDA
-27-
Market
Size (in
millions)(2)
$715
Rights(3)
Intellipharmaceutics
and Par
ANDA
ANDA
$763
Intellipharmaceutics
ANDA
$360
Intellipharmaceutics
ANDA
$768
Intellipharmaceutics
ANDA
$1,247
Intellipharmaceutics
ANDA
$442
Intellipharmaceutics
ANDA
$154
Intellipharmaceutics
ANDA
$778
Intellipharmaceutics
Generic name
Brand
Indication
Stage of Development(1) Regulatory
Pathway
Trazodone
hydrochloride extended
release tablets
Carvedilol phosphate
extended-release
capsules
Oxycodone
hydrochloride
controlled-release
capsules
Pregabalin extended-
release capsules
Oleptro®
Depression
Coreg CR®
Heart failure,
hypertension
ANDA application for
commercialization approval
for 2 strengths under review
by the FDA
Late-stage development
OxyContin® Pain
Phase I clinical trial
Lyrica®
Neuropathic pain Phase I clinical trial
Market
Size (in
millions)(2)
$2
Rights(3)
Intellipharmaceutics
ANDA
ANDA
$263
Intellipharmaceutics
NDA
505(b)(2)
NDA
505(b)(2)
$2,294
Intellipharmaceutics
$3,146
Intellipharmaceutics
Notes:
(1)
(2)
(3)
There can be no assurance when, or if at all, the FDA will approve any product candidate for sale in the U.S. market.
Represents sales for all strengths for the 12 months ended December 2014 in the U.S., including sales of generics in TRx MBS
Dollars, which represents projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer’s
published catalog or list prices to wholesalers, and does not represent actual transaction prices and does not include prompt pay or
other discounts, rebates or reductions in price. Source: Source Healthcare Analytics.
For unpartnered products, we are exploring licensing agreement opportunities or other forms of distribution. While we believe that a
licensing agreement is possible, there can be no assurance that one can be secured.
We typically select products for development that we anticipate could achieve FDA approval for commercial sales several years in the
future. However, the length of time necessary to bring a product to the point where the product can be commercialized can vary
significantly and depends on, among other things, the availability of funding, design and formulation challenges, safety or efficacy, patent
issues associated with the product, and FDA review times.
Dexmethylphenidate Hydrochloride – Generic Focalin XR® (a registered trademark of the brand manufacturer)
Dexmethylphenidate hydrochloride, a Schedule II restricted product (drugs with a high potential for abuse) in the United States, is
indicated for the treatment of attention deficit hyperactivity disorder. On November 21, 2005, we entered into the Par agreement pursuant
to which we granted Par an exclusive, royalty-free license to make and distribute in the United States all strengths of our generic Focalin
XR® (dexmethylphenidate hydrochloride extended-release) capsules for a period of 10 years from the date of commercial launch (which
was November 19, 2013). Under the Par agreement, we own the related ANDA, as approved by the FDA, and we retain the right to make
and distribute all strengths of the generic product outside of the United States. Calendar quarterly payments are payable by Par to us as
calculated pursuant to a formula depending on a number of factors applicable to each strength. The Par agreement also provides the
potential, in limited circumstances, for certain milestone payments being payable to us by Par, with the amount of such payments
dependent upon the number of competitors in the market within the first 180 days of commercialization, on a strength by strength basis.
We are responsible under the Par agreement for the development of the product and most related costs which, with the applications to and
recent approvals by the FDA, we now consider to be completed.
Our FDA filings for approval to market generic Focalin XR® capsules in various strengths gave rise in the usual course to
Paragraph IV patent litigation against the Company and Par by Novartis Pharmaceuticals Corporation, Novartis Pharma AG, Celgene
Corporation, Elan Corporation, plc and Elan Pharma International Ltd. and Alkermes Pharma Ireland Limited (successor in title to Elan
Pharma International Ltd) in the United States District Courts for New Jersey and Delaware. In each case, such litigation was settled by
stipulations of dismissal together with settlement and license agreements among the parties. By these agreements, Par and the Company
may market these generic versions of the product in the U.S., subject to agreed market entry dates and FDA approvals.
We received final approval from the FDA in November 2013 to launch the 15 and 30 mg strengths our generic Focalin XR®
(dexmethylphenidate hydrochloride extended-release) capsules. Commercial sales of these strengths were launched immediately by our
commercialization partner in the United States, Par. As the first-filer
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for the drug product in the 15 mg strength, we had 180 days (up to May 19, 2014) of exclusivity of sales for the generic product of that
strength from the date of launch on November 19, 2013 in the United States by our partner, Par. Our 5, 10, 20 and 40 mg strengths were
also tentatively FDA approved, subject to the right of another party or parties to 180 days of generic exclusivity from the date of first
launch of such products by such parties. We believe that Teva launched their own 5 mg strength of generic Focalin XR® capsules on
November 11, 2014. We believe that Par intends to launch the 5mg strength in May 2015, upon the expiry of the exclusivity period, but
there can be no assurance as to when or if the launch will occur. There can be no assurance as to when or if final FDA approval will be
received for the remaining product strengths we have applied for or that any of these strengths tentatively approved will ever be
successfully commercialized.
For discussion of the seasonality of sales of dexmethylphenidate hydrochloride extended-release capsules see the section entitled
“A. Operating Results” under “Item 5. Operating and Financial Review and Prospects”.
RexistaTM Oxycodone (Oxycodone Hydrochloride Controlled-Release)
One of our non-generic products under development is RexistaTM oxycodone (oxycodone hydrochloride controlled-release
capsules), intended as an abuse- and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride for the relief of pain.
RexistaTM oxycodone is an investigational drug, with a unique long acting oral formulation of oxycodone intended to treat moderate-to-
severe pain when a continuous, around the clock opioid analgesic is needed for an extended period of time. RexistaTM oxycodone is
designed to discourage common methods of tampering associated with misuse and abuse of such prescription opioid analgesic.
RexistaTM is intended to provide deterrence against intentional drug abuse and unintentional dose dumping. Dose dumping is the
rapid release of an active ingredient from a controlled-release drug into the blood stream that can result in increased toxicity, side effects,
and a loss of efficacy. Dose dumping can result by consuming the drug through crushing, taking with alcohol, extracting with other
beverages, vaporizing or injecting.
We conducted a randomized, cross-over, comparative bioavailability, Phase I clinical trial on 12 subjects in a fasted state
comparing a single dose of 40 mg RexistaTM oxycodone with a single dose of 40 mg OxyContin®. In this study, the bioavailability of a
single dose of RexistaTM oxycodone was equivalent to that of OxyContin®, as measured by the respective areas under the curve (“ AUC”).
The value for AUC essentially provides an estimation of total drug exposure by comparing ratios between RexistaTM oxycodone and
OxyContin®. The ratios obtained were within 80% - 125% at the 90% confidence interval. This indicates that the technology platform in
our formulation of RexistaTM oxycodone, nPODDDSTM, does not interfere with the bioavailability of oxycodone. We intend to apply the
nPODDDSTM technology platform to other opioid drug candidates (e.g., oxymorphone, hydrocodone, and morphine).
The FDA is actively developing a regulatory program for the narcotic analgesic class of products. In January 2013, the FDA
issued a draft guidance document, “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling”, to assist the industry in
developing new formulations of opioid drugs with abuse-deterrent properties. In April 2013, the FDA approved updated labeling for
reformulated OxyContin® tablets. The new labeling indicates that the physical and chemical properties of reformulated OxyContin® are
expected to make abuse via injection difficult, and to reduce abuse via the intranasal route. The original OxyContin® was withdrawn for
reasons of safety or effectiveness, resulting in the FDA refusing to accept or approve any ANDA of original OxyContin®.
Our Rexista™ oxycodone product candidate has been further enhanced with our PODRAS™ (Paradoxical OverDose Resistance
Activating System) delivery technology, designed to prevent overdose when more pills than prescribed are swallowed intact. Preclinical
studies of Rexista™ oxycodone suggest that, unlike other third-party abuse-deterrent oxycodone products, if more tablets than prescribed
are deliberately or inadvertently swallowed, the amount of drug active released over 24 hours may be substantially less than expected.
However, if the prescribed number of pills is swallowed, the drug release should be as expected. Subject to the availability of funds, we
expect to begin a series of clinical trials in Canada and the United States in the coming months to further evaluate Rexista™ incorporating
our PODRAS™ platform.
We believe that we can leverage our core competencies in drug delivery and formulation for the development of products targeted
towards tamper-deterrent opioid analgesics used in pain management. The
-29-
advantage of our strategy for development of NDA drugs is that our products can, if approved for sale, enjoy a sales exclusivity period.
Furthermore, it may be possible to establish and defend the intellectual property surrounding our tamper-deterrent opioid analgesic
products.
There can be no assurance as to whether or when the FDA will approve any Intellipharmaceutics’ Rexista TM oxycodone
application.
Regabatin XR (Pregabalin Extended-Release)
Another Intellipharmaceutics non-generic controlled-release product under development is RegabatinTM XR, pregabalin extended-
release capsules. Pregabalin is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy,
postherpetic neuralgia, spinal cord injury and fibromyalgia. A controlled-release version of pregabalin should reduce the number of doses
patients take, which could improve patient compliance, and therefore possibly enhance clinical outcomes. Lyrica® pregabalin, twice-a-day
(“BID”) and three-times-a-day (“TID”), are drug products marketed in the United States by Pfizer Inc. There is no controlled-release
formulation on the market at this time. A controlled-release version of pregabalin should reduce the number of doses patients take,
potentially improving patient compliance, and therefore potentially improving clinical outcomes.
In the first quarter of 2014, we conducted and analyzed the results of six Phase I clinical trials involving a twice-a-day formulation
and a once-a-day formulation. For formulations directed to certain indications which include fibromyalgia, the results suggested that
Regabatin™ XR 82.5 mg BID dosage was comparable in bioavailability to Lyrica® 50 mg (immediate-release pregabalin) TID dosage. For
formulations directed to certain other indications which include neuropathic pain associated with diabetic peripheral neuropathy, the results
suggested that Regabatin™ XR 165 mg once-a-day dosage was comparable in bioavailability to Lyrica® 75 mg BID dosage. The results
also suggested that Regabatin™ XR 165mg once-a-day has a higher exposure during the first 12 hours than Lyrica® 75mg BID. Together
with the symptomatology and chronobiology of fibromyalgia, this could prove to be advantageous with evening meal dosing and suggests
that once a day Regabatin™ XR 165mg once a-day may confer a compliance advantage over Lyrica® 75mg BID which is currently
administered for treatment of fibromyalgia. We are in discussion with the FDA with a view to having an investigational new drug
application (“IND”) submitted under the NDA 505(b)(2) regulatory pathway, for possible commercialization in the United States following
the December 30, 2018 expiry of the patent covering the pregabalin molecule. There can be no assurance that any additional Phase I or
other clinical trials we conduct will meet our expectations, that we will have sufficient capital to conduct such trials, that we will be
successful in submitting an NDA 505(b)(2) filing with the FDA, that the FDA will approve this product candidate for sale in the U.S.
market, or that it will ever be successfully commercialized.
COMPETITIVE ENVIRONMENT
We are engaged in a business characterized by extensive research efforts, rapid technological developments and intense
competition. Our competitors include medical technology, pharmaceutical, biotechnology and other companies, universities and research
institutions. All of these competitors currently engage in, have engaged in or may engage in the future, in development, manufacturing,
marketing and commercialization of new pharmaceuticals and existing pharmaceuticals, some of which may compete with our present or
future products and product candidates.
Our drug delivery technologies may compete with existing drug delivery technologies, as well as new drug delivery technologies
that may be developed or commercialized in the future. Any of these drugs and drug delivery technologies may receive government
approval or gain market acceptance more rapidly than our products and product candidates. As a result, our products and product
candidates may become non-competitive or obsolete.
We believe that our ability to successfully compete will depend on, among other things, the efficacy, safety and reliability of our
products and product candidates, the timing and scope of regulatory approval, the speed at which we develop product candidates, our, or
our commercialization partners’, ability to manufacture and sell commercial quantities of a product to the market, product acceptance by
physicians and other professional healthcare providers, the quality and breadth of our technologies, the skills of our employees and our
ability to
-30-
recruit and retain skilled employees, the protection of our intellectual property, and the availability of substantial capital resources to fund
development and commercialization activities.
MANUFACTURING
We have internal manufacturing capabilities consisting of current Good Laboratory Practices (“ cGLP”) research laboratories and
a cGMP manufacturing plant for solid oral dosage forms at our 30 Worcester Road facility in Toronto. Raw materials used in
manufacturing our products are available from a number of commercial sources and the prices for such raw materials are generally not
particularly volatile.
INTELLECTUAL PROPERTY
Proprietary rights are an important aspect of our business. These include know-how, trade secrets and patents. Know-how and
trade secrets are protected by internal company policies and operating procedures, and where necessary, by contractual provisions with
development partners and suppliers. We also seek patent protection for inventive advances which form the bases of our drug delivery
technologies. With respect to particular products, we may seek patent protection on the commercial composition, our methods of
production and our uses, to prevent the unauthorized marketing and sale of competitive products.
Patents which relate to and protect various aspects of our HypermatrixTM family of drug delivery technologies include the
following United States, Japanese, Canadian and European patents which have been issued to us:
Country
U.S.A
U.S.A.
U.S.A
U.S.A
U.S.A
U.S.A
U.S.A
U.S.A
U.S.A
U.S.A
U.S.A
Japan
Japan
Canada
Canada
Canada
Canada
Canada
Canada
Canada
Europe
Issue Date
Dec 10, 2013
Mar 12, 2013
Mar 15, 2011
Dec 28, 2010
Aug 15, 2006
Oct 5, 2004
Nov 25, 2003
Aug 19, 2003
Nov 12, 2002
Oct 2, 2001
Aug 12, 2014
Aug 30, 2013
Aug 8, 2014
Jun 19, 2012
Sep 25, 2012
Feb 22, 2011
Mar 15, 2005
Jan 28, 2014
Apr 8, 2014
Mar 11, 2014
Nov 26, 2014
Issue No.
8,603,520
8,394,409
7,906,143
7,858,119
7,090,867
6,800,668
6,652,882
6,607,751
6,479,075
6,296,876
8,802,139
5,349,290
5,592,547
2,626,558
2,529,984
2,459,857
2,435,276
2,571,897
2,576,556
2,648,280
2,007,360
Title
Oral Multi-functional Pharmaceutical Capsule Preparations of Proton Pump Inhibitors
Controlled Extended Drug Release Technology
Controlled Release Pharmaceutical Delivery Device and Process for Preparation Thereof
Extended Release Pharmaceuticals
Novel Controlled Release Delivery Device for Pharmaceutical Agents Incorporating
Microbial Polysaccharide Gum
Syntactic Deformable Foam Compositions and Methods for Making
Controlled Release Formulation Containing Bupropion
Novel Controlled Release Delivery Device for Pharmaceutical Agents Incorporating
Microbial Polysaccharide Gum
Pharmaceutical Formulations for Acid Labile Substances
Pharmaceutical Formulations for Acid Labile Substances
Proton Pump-Inhibitor-Containing Capsules Which Comprise Subunits Differently
Structured For A Delayed Release Of The Active Ingredient
Drug Delivery Composition
Drug Delivery Composition
Pharmaceutical Composition having Reduced Abuse Potential
Oral Multi-Functional Pharmaceutical Capsule Preparations of Proton Pump Inhibitors
Combinatorial Type Controlled Release Drug Delivery Device
Syntactic Deformable Foam Compositions and Methods for Making
Controlled Extended Drug Release Technology
Drug Delivery Device
Controlled Release Delivery Device Comprising an Organosol Coat
Controlled Release Delivery Device Comprising an Organosol Coat
In addition to these issued patents, we have several U.S. patent applications, and corresponding foreign applications pending,
including Patent Cooperation Treaty - national stage processing and entry applications, relating to various aspects of our HyperMatrixTM
drug delivery technologies, including methods and compositions
-31-
for coating of tablets and beads, compositions incorporating disintegrants to assist in controlled release, compositions incorporating
multiple drug actives, and compositions directed to classes of drug actives designed as therapies for specific indications and compositions
intended to enhance deterrence of willful abuse of narcotic compositions.
REGULATORY REQUIREMENTS
We focus on the development of both branded drug products (which require NDAs) and generic drug products (which require
ANDAs). The research and development, manufacture and marketing of controlled-release pharmaceuticals are subject to regulation by
U.S., Canadian and other governmental authorities and agencies. Such national agencies and other federal, state, provincial and local
entities regulate the testing, manufacturing, safety and promotion of our products. The regulations applicable to our products may change as
the currently limited number of approved controlled-release products increases and regulators acquire additional experience in this area.
United States Regulation
New Drug Application
We will be required by the FDA to comply with NDA procedures for our branded products prior to commencement of marketing
by us or our licensees. New drug compounds and new formulations for existing drug compounds which cannot be filed as ANDAs are
subject to NDA procedures. These procedures include (a) preclinical laboratory and animal toxicology tests; (b) scaling and testing of
production batches; (c) submission of an IND, and subsequent approval is required before any human clinical trials can commence; (d)
adequate and well controlled replicate human clinical trials to establish the safety and efficacy of the drug for its intended indication; (e) the
submission of an NDA to the FDA; and (f) FDA approval of an NDA prior to any commercial sale or shipment of the product, including
pre-approval and post-approval inspections of our manufacturing and testing facilities. If all of this data in the product application is owned
by the applicant, the FDA will issue its approval without regard to patent rights that might be infringed or exclusivity periods that would
affect the FDA’s ability to grant an approval if the application relied upon data which the applicant did not own. We intend to generate all
data necessary to support FDA approval of the applications we file.
Preclinical laboratory and animal toxicology tests may have to be performed to assess the safety and potential efficacy of the
product. The results of these preclinical tests, together with information regarding the methods of manufacture of the products and quality
control testing, are then submitted to the FDA as part of an IND requesting authorization to initiate human clinical trials. Once the IND
notice period has expired, clinical trials may be initiated, unless an FDA hold on clinical trials has been issued.
Clinical trials involve the administration of a pharmaceutical product to individuals under the supervision of qualified medical
investigators who are experienced in conducting studies under “Good Clinical Practice” guidelines. Clinical studies are conducted in
accordance with protocols that detail the objectives of a study, the parameters to be used to monitor safety and the efficacy criteria to be
evaluated. Each protocol is submitted to the FDA and to an Institutional Review Board prior to the commencement of each clinical trial.
Clinical studies are typically conducted in three sequential phases, which may overlap. In Phase I, the initial introduction of the product
into human subjects, the compound is tested for absorption, safety, dosage, tolerance, metabolic interaction, distribution, and excretion.
Phase II involves studies in a limited patient population with the disease to be treated to (1) determine the efficacy of the product for
specific targeted indications, (2) determine optimal dosage and (3) identify possible adverse effects and safety risks. In the event Phase II
evaluations demonstrate that a pharmaceutical product is effective and has an acceptable safety profile, Phase III clinical trials are
undertaken to further evaluate clinical efficacy of the product and to further test its safety within an expanded patient population at
geographically dispersed clinical study sites. Periodic reports on the clinical investigations are required.
We, or the FDA, may suspend clinical trials at any time if either party believes the clinical subjects are being exposed to
unacceptable health risks. The results of the product development, analytical laboratory studies and clinical studies are submitted to the
FDA as part of an NDA for approval of the marketing and commercialization of a pharmaceutical product.
-32-
Abbreviated New Drug Application
In certain cases, where the objective is to develop a generic version of an approved product already on the market in controlled-
release dosages, an ANDA may be filed in lieu of filing an NDA. Under the ANDA procedure, the FDA waives the requirement to submit
complete reports of preclinical and clinical studies of safety and efficacy and instead requires the submission of bioequivalency data, that is,
demonstration that the generic drug produces the same effect in the body as its brand-name counterpart and has the same pharmacokinetic
profile, or change in blood concentration over time. The ANDA procedure is available to us for a generic version of a drug product
approved by the FDA. In certain cases, an ANDA applicant may submit a suitability petition to the FDA requesting permission to submit
an ANDA for a drug product that differs from a previously approved reference drug product (the “ Listed Drug”) when the change is one
authorized by statute. Permitted variations from the Listed Drug include changes in: (1) route of administration, (2) dosage form, (3)
strength and (4) one of the active ingredients of the Listed Drug when the Listed Drug is a combination product. The FDA must approve
the petition before the ANDA may be submitted. An applicant is not permitted to petition for any other kinds of changes from Listed
Drugs. The information in a suitability petition must demonstrate that the change from the Listed Drug requested for the proposed drug
product may be adequately evaluated for approval without data from investigations to show the proposed drug product’s safety or
effectiveness. The advantages of an ANDA over an NDA include reduced research and development costs associated with bringing a
product to market, and generally a shorter review and approval time at the FDA.
GDUFA implemented substantial fees for new ANDAs, Drug Master Files, product and establishment fees and a one-time fee for
back-logged ANDAs pending approval as of October 1, 2012. In return, the program is intended to provide faster and more predictable
ANDA reviews by the FDA and more timely inspections of drug facilities. For the FDA’s fiscal years 2014 and 2015, respectively, the user
fee rates are $63,860 and $58,730 for new ANDAs, $31,920 and $29,370 for Prior Approval Supplements, and $17,434 for each ANDA
already on file at the FDA. For the FDA’s fiscal years 2014 and 2015, there is also an annual facility user fee of $235,152 and $262,717,
respectively. Under GDUFA, generic product companies face significant penalties for failure to pay the new user fees, including rendering
an ANDA not “substantially complete” until the fee is paid. It is currently uncertain the effect the new fees will have on our ANDA process
and business. However, any failure by us or our suppliers to pay the fees or to comply with the other provisions of GDUFA may adversely
impact or delay our ability to file ANDAs, obtain approvals for new generic products, generate revenues and thus may have a material
adverse effect on our business, results of operations and financial condition.
Patent Certification and Exclusivity Issues
ANDAs are required to include certifications with respect to any third party patents that claim the Listed Drug or that claim a use
for the Listed Drug for which the applicant is seeking approval. If applicable third party patents are in effect and this information has been
submitted to the FDA, the FDA must delay approval of the ANDA until the patents expire. If the applicant believes it will not infringe the
patents, it can make a patent certification to the holder of patents on the drug for which a generic drug approval is being sought, which may
result in patent infringement litigation which could delay the FDA approval of the ANDA for up to 30 months. If the drug product covered
by an ANDA were to be found by a court to infringe another company’s patents, approval of the ANDA could be delayed until the patents
expire. Under the Food Drug and Cosmetic Act (“FDC”), the first filer of an ANDA with a “non-infringement” certification is entitled to
receive 180 days of market exclusivity. Subsequent filers of generic products would be entitled to market their approved product six months
after the earlier of the first commercial marketing of the first filer’s generic product or a successful defense of a patent infringement suit. A
company having approval and permission from the original brand owner is able to market an authorized generic at any time. In the case of
our 15 mg dexmethylphenidate hydrochloride extended-release capsules, commercial sales commenced on or about November 19, 2013
and therefore subsequent filers will be entitled to enter the market no earlier than 180 days after such commencement date.
The 180-day exclusivity period can be forfeited if the first applicant withdraws its application or the FDA considers the application
to have been withdrawn, the first applicant amends or withdraws Paragraph IV Certification for all patents qualifying for 180 day
exclusivity, or the first applicant fails to obtain tentative approval within 30 months after the date filed unless, failure is due to a change in
review requirements. The preservation of the 180 day exclusivity period related to the first-to-file status of a drug not approved within 30
months after the date filed, generally requires that an application be made to the FDA for extension of the time period where the
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delay has been due to a change in the review requirements for the drug. The approval of the continued first-to-file status in such
circumstances is subject to the discretion of the FDA. There can be no assurance that the FDA would accede to such a request if made.
Patent expiration refers to expiry of U.S. patents (inclusive of any extensions) on drug compounds, formulations and uses. Patents
outside the United States may differ from those in the United States. Under U.S. law, the expiration of a patent on a drug compound does
not create a right to make, use or sell that compound. There may be additional patents relating to a person’s proposed manufacture, use or
sale of a product that could potentially prohibit such person’s proposed commercialization of a drug compound.
The FDC contains non-patent market exclusivity provisions that offer additional protection to pioneer drug products and are
independent of any patent coverage that might also apply. Exclusivity refers to the fact that the effective date of approval of a potential
competitor’s ANDA to copy the pioneer drug may be delayed or, in certain cases, an ANDA may not be submitted until the exclusivity
period expires. Five years of exclusivity are granted to the first approval of a “new chemical entity”. Three years of exclusivity may apply
to products which are not new chemical entities, but for which new clinical investigations are essential to the approval. For example, a new
indication for use, or a new dosage strength of a previously approved product, may be entitled to exclusivity, but only with respect to that
indication or dosage strength. Exclusivity only offers protection against a competitor entering the market via the ANDA route, and does not
operate against a competitor that generates all of its own data and submits a full NDA.
If applicable regulatory criteria are not satisfied, the FDA may deny approval of an NDA or an ANDA or may require additional
testing. Product approvals may be withdrawn if compliance with regulatory standards is not maintained or if problems occur after the
product reaches the market. The FDA may require further testing and surveillance programs to monitor the pharmaceutical product that has
been commercialized. Non-compliance with applicable requirements can result in additional penalties, including product seizures,
injunction actions and criminal prosecutions.
Canadian Regulation
The requirements for selling pharmaceutical drugs in Canada are substantially similar to those of the United States described
above.
Investigational New Drug Application
Before conducting clinical trials of a new drug in Canada, we must submit a Clinical Trial Application (“CTA”) to the Therapeutic
Products Directorate (“TPD”). This application includes information about the proposed trial, the methods of manufacture of the drug and
controls, preclinical laboratory and animal toxicology tests on the safety and potential efficacy of the drug, and information on any
previously executed clinical trials with the new drug. If, within 30 days of receiving the application, the TPD does not notify us that our
application is unsatisfactory, we may proceed with clinical trials of the drug. The phases of clinical trials are the same as those described
above under “United States Regulation – New Drug Application”.
New Drug Submission
Before selling a new drug in Canada, we must submit a New Drug Submission (“NDS”) or Supplemental New Drug Submission
(“sNDS”) to the TPD and receive a Notice of Compliance (“NOC”) from the TPD to sell the drug. The submission includes information
describing the new drug, including its proper name, the proposed name under which the new drug will be sold, a quantitative list of
ingredients in the new drug, the methods of manufacturing, processing, and packaging the new drug, the controls applicable to these
operations, the tests conducted to establish the safety of the new drug, the tests to be applied to control the potency, purity, stability and
safety of the new drug, the results of bio-pharmaceutics and clinical trials as appropriate, the intended indications for which the new drug
may be prescribed and the effectiveness of the new drug when used as intended. The TPD reviews the NDS or sNDS. If the submission
meets the requirements of Canada’s Food and Drugs Act and Regulations, the TPD will issue an NOC for the new drug.
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Where the TPD has already approved a drug for sale in controlled-release dosages, we may seek approval from the TPD to sell an
equivalent generic drug through an Abbreviated New Drug Submission (“ ANDS”). In certain cases, the TPD does not require the
manufacturer of a proposed drug that is claimed to be equivalent to a drug that has already been approved for sale and marketed, to conduct
clinical trials; instead, the manufacturer must satisfy the TPD that the drug is bioequivalent to the drug that has already been approved and
marketed.
The TPD may deny approval or may require additional testing of a proposed new drug if applicable regulatory criteria are not met.
Product approvals may be withdrawn if compliance with regulatory standards is not maintained or if problems occur after the product
reaches the market. Contravention of Canada’s Food and Drugs Act and Regulations can result in fines and other sanctions, including
product seizures and criminal prosecutions.
Proposals have recently been made that, if implemented, would significantly change Canada’s drug approval system. In general,
the recommendations emphasize the need for efficiency in Canadian drug review. Proposals include establishment of a separate agency for
drug regulation and modeling the approval system on those found in European Union countries. There is no assurance, however, that such
changes will be implemented or, if implemented, will expedite the approval of new drugs.
The Canadian government has regulations which can prohibit the issuance of an NOC for a patented medicine to a generic
competitor, provided that the patentee or an exclusive licensee has filed a list of its Canadian patents covering that medicine with the
Minister of Health and Welfare. After submitting the list, the patentee or an exclusive licensee can commence a proceeding to obtain an
order of prohibition directed to the Minister prohibiting him or her from issuing an NOC. The minister may be prohibited from issuing an
NOC permitting the importation or sale of a patented medicine to a generic competitor until patents on the medicine expire or the waiver of
infringement and/or validity of the patent(s) in question is resolved by litigation in the manner set out in such regulations. There may be
additional patents relating to a company’s proposed manufacture, use or sale of a product that could potentially prohibit such company’s
proposed commercialization of a drug compound.
Certain provincial regulatory authorities in Canada have the ability to determine whether the consumers of a drug sold within such
province will be reimbursed by a provincial government health plan for that drug by listing drugs on formularies. The listing or non-listing
of a drug on provincial formularies may affect the prices of drugs sold within provinces and the volume of drugs sold within provinces.
Additional Regulatory Considerations
Sales of our products by our licensees outside the United States and Canada will be subject to regulatory requirements governing
the testing, registration and marketing of pharmaceuticals, which vary widely from country to country.
Under the U.S. Generic Drug Enforcement Act, ANDA applicants (including officers, directors and employees) who are convicted
of a crime involving dishonest or fraudulent activity (even outside the FDA regulatory context) are subject to debarment. Debarment is
disqualification from submitting or participating in the submission of future ANDAs for a period of years or permanently. The Generic
Drug Enforcement Act also authorizes the FDA to refuse to accept ANDAs from any company which employs or uses the services of a
debarred individual. We do not believe that we receive any services from any debarred person.
In addition to the regulatory approval process, pharmaceutical companies are subject to regulations under provincial, state and
federal law, including requirements regarding occupational safety, laboratory practices, environmental protection and hazardous substance
control, and may be subject to other present and future local, provincial, state, federal and foreign regulations, including possible future
regulations of the pharmaceutical industry. We believe that we are in compliance in all material respects with such regulations as are
currently in effect.
Before medicinal products can be distributed commercially, a submission providing detailed information must be reviewed and
approved by the applicable government or agency in the jurisdiction in which the product is to be marketed. The regulatory review and
approval process varies from country to country.
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C.
Organizational Structure
The following chart shows the corporate relationship structure of Intellipharmaceutics and its three wholly-owned subsidiaries,
including jurisdictions of incorporation, as of the date of this annual report.
D.
Property, Plant and Equipment
For approximately ten years, we have occupied a 25,000 square foot facility at 30 Worcester Road, Toronto, Ontario, Canada
M9W 5X2, that we lease at a present rental rate of approximately $90,000 per year. The lease has been renewed to November 2015, and
the Company has an option to extend the lease for five additional years on terms we currently believe to be favourable. We use our
facilities as a cGLP research laboratory, office space, and cGMP scale-up and small to medium-scale manufacturing plant for solid oral
dosage forms. The facility now consists of approximately 4,900 sq. ft. for administrative space, 4,300 sq. ft. for R&D, 9,200 sq. ft. for
manufacturing, and 3,000 sq. ft. for warehousing.
We continually monitor our facility requirements in the context of our needs and we expect these requirements to change
commensurately with our activities.
In October 2014, the FDA provided the Company with written notification that its Toronto, Canada manufacturing facility had
received an “acceptable” classification. Such inspections are carried out on a regular basis by the FDA and an “acceptable” classification is
necessary to permit the Company to be in a position to receive final approvals for ANDAs and NDAs and to permit manufacturing of drug
products intended for commercial sales in the United States after any such approvals.
Item 4A.
Unresolved Staff Comments
Not applicable.
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Item 5.
Operating and Financial Review and Prospects
The following discussion and analysis should be read in conjunction with the audited annual consolidated financial statements of
the Company and notes thereto. See “Item 18. Financial Statements”. The consolidated financial statements have been prepared in
accordance with U.S. GAAP. All amounts are expressed in United States dollars unless otherwise noted. Annual references are to the
Company’s fiscal years, which ended on November 30, 2014, 2013 and 2012.
A.
Operating Results
Our results of operations have fluctuated significantly from period to period in the past and are likely to do so in the future. We
anticipate that our quarterly and annual results of operations will be impacted for the foreseeable future by several factors, including the
timing of approvals to market our product candidates in various jurisdictions and any resulting licensing revenue, milestone revenue,
product sales, the timing and amount of payments received pursuant to our current and future collaborations with third parties, and the
progress and timing of expenditures related to our research, development and commercialization efforts. Due to these fluctuations, we
presently believe that the period-to-period comparisons of our operating results are not a reliable indication of our future performance.
Effective December 1, 2013, the Company changed its functional currency from Canadian dollars to U.S. dollars on a prospective
basis. The U.S. dollar translated amounts of nonmonetary assets and liabilities at December 1, 2013 became the historical accounting basis
for those assets and liabilities at December 1, 2013. Prior to the Company’s change in its functional currency, U.S. GAAP required the fair
values of certain derivative liabilities to be re-valued at the end of every reporting period with the change in value reported in the
consolidated statements of operations and comprehensive loss. Subsequent to the change in functional currency, U.S. GAAP requires the
reclassification of the derivative liabilities to equity and there is no further re-valuation at the end of every reporting period. Further
discussion of the impact is discussed under the section titled “Fair Value Adjustment of Derivative Liabilities.”
The following are selected financial data for the years ended November 30, 2014, 2013 and 2012.
For the years ended
November 30, November 30, November 30,
2013
2012
2014
$
$
$
Change
2014 vs 2013
$
%
Change
2013 vs 2012
$
%
Revenue:
Licensing
Milestone
Research and development
Other incidental services
8,415,540
354,153
-
-
8,769,693
1,481,719
43,209
-
2,546
1,527,474
- 6,933,821
- 310,944
468% 1,481,719 N/A
43,209 N/A
720%
107,091
-
- N/A
(2,546) N/A
(107,091)
-100%
2,546 N/A
107,091 7,242,219
474% 1,420,383 1326%
Expenses:
Research and development
Selling, general and administrative
Depreciation
Write-down on long lived assets
8,020,201
3,900,803
381,385
-
12,302,389
5,076,236
2,873,091
396,814
-
5,992,417 2,943,965
3,672,313 1,027,712
(15,429)
-
8,346,141 10,224,156 3,956,248
452,303
107,123
58%
36%
-4%
-
(916,181)
(799,222)
(55,489)
(107,123) N/A
-15%
-22%
-12%
47% (1,878,015)
-18%
Loss from operations
(3,532,696)
(6,818,667) (10,117,065) 3,285,971
-48% 3,298,398
-33%
Fair value adjustment of derivative
liabilities
Financing expense
Net foreign exchange gain (loss)
Interest income
Interest expense
-
-
10,896
4,898
(339,451)
(3,889,683)
(115,056)
(359,554)
2,839
(314,896)
3,841,233 3,889,683
- 115,056
181,682 370,450
2,059
(24,555)
20,691
(63,406)
-201%
-100% (7,730,916)
-100%
-103%
73%
8%
(115,056) N/A
(541,236)
(17,852)
(251,490)
-298%
-86%
397%
Net loss
(3,856,353) (11,495,017)
(6,136,865) 7,638,664
-66% (5,358,152)
87%
Year Ended November 30, 2014 Compared to the Year Ended November 30, 2013
Revenue
The Company recorded revenues of $8,769,693 for the year ended November 30, 2014 versus $1,527,474 for the year ended
November 30, 2013. In November 2013 the Company received FDA approval of its generic Focalin XR® (dexmethylphenidate
hydrochloride extended-release) capsules for the 15 and 30 mg strengths. Commercial sales of these strengths were launched immediately
by our commercialization partner for these drugs in the United States, Par. As the first-filer for the drug product in the 15 mg strength, we
had 180 days (up to May 19, 2014) of exclusivity of sales for the generic product of that strength from the date of launch on November 19,
2013
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in the United States by our partner, Par. Subsequent to May 19, 2014 we no longer retained generic exclusivity of the 15 mg strength. This
revenue represents the commercial sales of the generic product in those strengths and may not be representative of future sales. We believe
sales of dexmethylphenidate hydrochloride extended-release capsules are subject to seasonal fluctuations.
In the first half of 2014, we recognized licensing revenue of $5,805,847 from commercial sales of 15 and 30 mg strengths of generic
Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules under the Par agreement. We also recorded milestone revenue
of $354,153 under the Par agreement, which is tied to the achievement of our product being either the only generic in the market or having
only one generic competitor. In the second half of 2014 we recognized licensing revenue of $2,609,693 from commercial sales of 15 and 30
mg strengths of generic Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules under the Par agreement.
Research and Development
Expenditures for R&D for the year ended November 30, 2014 were $8,020,201 in comparison to $5,076,236 in the prior year, an
increase of $2,943,965. These included spending for R&D activities as well as expenses on stock options as detailed below.
In the year ended November 30, 2014, we recorded $1,270,307 as expenses for stock options for R&D employees. As a result of
the modification of the performance based stock option expiry date, we recorded additional compensation costs of $1,066,991 related to
vested performance options during the year ended November 30, 2014. In the prior year we recorded $837,206 as expenses for stock
options for R&D employees; this amount includes $442,800 expense for performance-based stock options.
After adjusting for the stock options expenses discussed above, expenditures for R&D for the year ended November 30, 2014 were
higher by $2,510,864 compared to the prior year. This increase over the prior year is due to increased expenses on furthering the
development of several generic and NDA 505(b)(2) product candidates, an increase in the number of non-management employees, and
salary increases for certain non-management employees.
In fiscal 2015, we expect to pursue possible financing alternatives, including potential partnering opportunities, in order to fund
clinical trials on NDA 505(b)(2) product candidates. There can be no assurance that we will be able to obtain any such financing on terms
or in amounts sufficient to meet our needs or at all.
Selling, General and Administrative
Selling, general and administrative expenses were $3,900,803 for the year ended November 30, 2014 in comparison to $2,873,091
for the year ended November 30, 2013, an increase of $1,027,712. The increase is due to an increase in expenses related to wages,
marketing cost and occupancy costs which are discussed in greater detail below.
Expenditure for wages and benefits for the year ended November 30, 2014 were $1,749,046 in comparison to $1,313,082 in the
prior year. In the year ended November 30, 2014, we recorded $478,300 as expenses for stock options compared to an expense of $316,676
for the prior year. After adjusting for the stock options expenses, expenditures for wages and benefits for the year ended November 30,
2014 were higher by $274,340 compared to the prior period primarily due to an increase in the number of management and non-
management employees, and salary increases for certain non-management employees .
Administrative costs for the year ended November 30, 2014 were $1,651,790 in comparison to $1,078,441 in the prior year. The
increase was due to higher expenditures in legal and accounting activities.
Marketing costs for the year ended November 30, 2014 were $418,472 in comparison to $388,889 in the prior year. There was no
significant change in these expenses. This increase is primarily the result of higher travel expenditures related to business development
activities.
Occupancy costs for the year ended November 30, 2014 were $81,495 in comparison to $92,679 in the prior year. The decrease is
due to the weakness of the Canadian dollar, as occupancy costs are denominated in Canadian dollars.
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Depreciation
Depreciation expenses for the year ended November 30, 2014 were $381,385 in comparison to $396,814 in the prior year. The
decrease is primarily due to the timing of additional investment in production, laboratory and computer equipment during the year ended
November 30, 2014.
Fair Value Adjustment of Derivative Liabilities
In July 2013, the Company completed an underwritten public offering for gross proceeds of approximately $3.1 million at a price
of $2.05 per unit. The Company sold an aggregate of 1,500,000 units of common shares and warrants to purchase an additional 375,000
common shares. The warrants are exercisable for a term of five years and have an exercise price of $2.55 per common share. In March
2013, the Company completed a registered direct unit offering for gross proceeds of approximately $3.1 million at a price of $1.72 per unit.
The Company sold an aggregate of 1,815,000 common shares and warrants to purchase an additional 453,750 common shares. The
warrants are exercisable for a term of five years and have an exercise price of $2.10 per common share. In February 2011, the Company
completed a private offering for the sale and issuance of 4,800,000 units of the Company, each unit consisting of one share of common
stock, a five year Series A common share purchase warrant to purchase one half of a share of common stock at an exercise price of $2.50
per whole share and a two year Series B common share purchase warrant to purchase one half of a share of common stock at an exercise
price of $2.50 per whole share. In February 2011, the Company also issued to the placement agents 96,000 warrants to purchase a whole
share of common stock at an exercise price of $3.125 per whole share.
Under U.S. GAAP, when the strike price of warrants is denominated in a currency other than an entity's functional currency, the
warrants would not be considered indexed to the entity’s own stock. At issuance, the Company determined that these warrants were not
considered indexed to the Company’s own stock and therefore were consequently considered to be a derivative liability. Subsequent
changes in the fair value of the warrants were recorded in the consolidated statements of operations and comprehensive loss. As a result,
for the year ended November 30, 2013, the Company recognized a fair value adjustment of derivative liability expense of $153,894.
Effective December 1, 2013, the Company changed its functional currency from Canadian dollars to U.S. dollars such that the
warrants are now considered indexed to the Company’s own stock and meet the criteria for prospective equity classification in ASC 480.
The warrant liability value at December 1, 2013 of $5,438,022 was reclassified from warrant liabilities to additional paid-in capital. As a
result, for the year ended November 30, 2014, there was no fair value adjustment of derivative liability expense recorded in the statement
of operations.
In January 2013, the Company completed the private placement financing of an unsecured Debenture in the aggregate principal
amount of $1.5 million. The Debenture was originally due to mature on January 1, 2015, but effective October 1, 2014, the maturity date
was extended to July 1, 2015. The Debenture bears interest at a rate of 12% per annum payable monthly, is pre-payable at any time at the
option of the Company, and is convertible at any time into 500,000 common shares at a conversion price of $3.00 per common share at the
option of the holder. The conversion price of the Debenture is in U.S. dollars and at issuance the Company’s functional currency was
Canadian dollars. As a result, for the year ended November 30, 2013, the Company recognized a fair value adjustment of derivative
liability expense of $8,168 in its statement of operations.
Under U.S. GAAP, when the conversion price of the Debenture is denominated in a currency other than an entity's functional
currency, the conversion option meets the definition of an embedded derivative. The conversion option was bifurcated from its host
contract and the fair value of the conversion option characterized as an embedded derivative at issuance. The embedded derivative was
presented on a combined basis with the host contract. The derivative was re-measured at the end of every reporting period with the change
in value reported in the consolidated statements of operations and comprehensive loss.
Effective December 1, 2013, the Company changed its functional currency from Canadian dollars to U.S. dollars such that the
conversion option no longer meets the criteria for bifurcation and was prospectively reclassified to equity under ASC 815. The conversion
option value at December 1, 2013 of $728,950 was reclassified from convertible debenture to additional paid-in capital. Consequently,
there was no fair value adjustment of derivative liability expense recorded in the statement of operations.
Prior to the Company’s change in its functional currency, U.S. GAAP required the fair values of these liabilities be re-valued at
the end of every reporting period with the change in value reported in the consolidated statements of operations and comprehensive loss.
Subsequent to the change in functional currency, U.S. GAAP
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requires the reclassification of the derivative liabilities to equity and there is no further re-valuation at the end of every reporting period.
Foreign Exchange Gain (Loss)
Foreign exchange gain was $10,896 for the year ended November 30, 2014 in comparison to a loss of $359,554 for the prior year.
The foreign exchange gain for the year ended November 30, 2014 was due to the weakening of the Canadian dollar against the U.S. dollar
throughout the year as the exchange rate averaged $1.00 for C$1.0973 compared to $1.00 for C$1.0241 for prior year. Based on our fiscal
year end dates, the Canadian dollar weakened against the U.S. dollar as the exchange rates changed to $1.00 for C$1.1440 at November 30,
2014 from $1.00 for C$1.0620 at November 30, 2013.
Interest Income
Interest income was $4,898 for the year ended November 30, 2014 in comparison to $2,839 for the year ended November 30,
2013, an increase of $2,059. For the year ended November 30, 2014 interest was higher largely due to a higher average amount of cash
equivalents on hand during 2014 compared to 2013.
Interest Expense
Interest expense was $339,451 for the year ended November 30, 2014 in comparison to $314,896 for the year ended November
30, 2013, an increase of $24,555. This is primarily because the interest expense paid in 2014, on the Debenture which accrues interest
payable at 12% annually and the related conversion option embedded derivative accreted at an annual imputed interest rate of
approximately 8%, was over a twelve month period in comparison to 2013 where the Debenture interest was over a ten month period.
Year Ended November 30, 2013 Compared to the Year Ended November 30, 2012
Revenue
The Company recorded revenues of $1,527,474 for the year ended November 30, 2013 versus $107,091 for 2012. In November
2013 the Company received FDA approval of our generic Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules for
the 15 and 30 mg strengths. Commercial sales of these strengths were launched immediately by our commercialization partner in the United
States, Par. As the first-filer for the drug product in the 15 mg strength, we had 180 days of exclusivity of generic sales from the date of
launch in the United States by our partner, Par. We recognized licensing revenue of $1,481,719, which is our licensing revenue from 12
days of commercial sales of 15 and 30 mg strengths of our generic Focalin XR® (dexmethylphenidate hydrochloride extended-release)
capsules under the Par agreement. This revenue represented the first commercial generic sales of those strengths and may not be
representative of post-launch sales. In 2013 we also accrued milestone revenue of $43,209 under the Par agreement tied to the achievement
of our product being either the only generic in the market or if there is only one generic competitor. In 2013 we also recorded other
incidental services revenue of $2,546 related to consulting services provided to other organizations regarding FDA standards. In 2011,
additional strengths of generic Focalin XR® were added to the Par agreement. Under the terms of the expanded agreement, the Company
received a cash payment of $600,000 from Par, of which $492,909 was recognized in the year ended November 30, 2011. During the year
ended November 30, 2012, the remaining deferred revenue of $107,091 was recognized as revenue mainly related to development work
completed for the 40 mg strength.
Research and Development
Expenditures for R&D for the year ended November 30, 2013 were $5,076,236 in comparison to $5,992,417 in the prior year, a
decrease of $916,181. These included spending for R&D activities as well as expenses on stock options as detailed below.
In the year ended November 30, 2013, we recorded $837,206 as expenses for stock options for R&D employees; this amount
includes $442,800 expense for performance-based stock options. In the prior year we recorded $1,505,061 as expenses for stock options for
R&D employees; there was no expense for performance-based stock options.
After adjusting for the stock options expenses discussed above, expenditures for R&D for the year ended November 30, 2013 were
slightly lower by $248,326 compared to the prior year. This is primarily attributed to the fact that during the year ended November 30,
2012, more R&D activities were conducted compared to the year ended November 30, 2013.
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Selling, General and Administrative
Selling, general and administrative expenses were $2,873,091 for the year ended November 30, 2013 in comparison to $3,672,313
for the year ended November 30, 2012, a decrease of $799,222. The decrease is due to a decrease in expenses related to wages, marketing
cost and occupancy costs which are discussed in greater detail below.
Expenditure for wages and benefits for the year ended November 30, 2013 were $1,313,082 in comparison to $1,946,535 in the
prior year. This decrease is attributable to the issuance of options in the prior year. In the year ended November 30, 2013, we recorded
$316,676 as expenses for stock options compared to an expense of $818,784 for the prior year. After adjusting for the stock options
expenses, expenditures for wages and benefits for the year ended November 30, 2013 were slightly lower by $131,345 compared to the
prior period, which is primarily attributed to the resignation of an executive of IPC Ltd.
Administrative costs for the year ended November 30, 2013 were $1,078,441 in comparison to $1,279,696 in the prior year. The
decrease is primarily due to business development expenses in the prior year, as well as higher expenditures in patents prosecution.
Marketing costs for the year ended November 30, 2013 were $388,889 in comparison to $352,803 in the prior year. There was no
significant change in these expenses.
Occupancy costs for the year ended November 30, 2013 were $92,679 in comparison to $93,279 in the prior year. The decrease is
due to the termination of a leased office for IPC Ltd.
Depreciation
Depreciation expenses for the year ended November 30, 2013 were $396,814 in comparison to $452,303 in the prior year. The
decrease is primarily due to lower investment in production, laboratory and computer equipment in the year ended November 30, 2013
compared to the prior year.
Fair Value Adjustment of Derivative Liabilities
In July 2013, the Company completed an underwritten public offering for gross proceeds of approximately $3.1 million at a price
of $2.05 per unit. The Company sold an aggregate of 1,500,000 units of common shares and warrants to purchase an additional 375,000
common shares. The warrants are exercisable for a term of five years and have an exercise price of $2.55 per common share. In March
2013, the Company completed a registered direct unit offering for gross proceeds of approximately $3.1 million at a price of $1.72 per unit.
The Company sold an aggregate of 1,815,000 common shares and warrants to purchase an additional 453,750 common shares. The
warrants are exercisable for a term of five years and have an exercise price of $2.10 per common share. In February 2011, the Company
completed a private offering for the sale and issuance of 4,800,000 units of the Company, each unit consisting of one share of common
stock, a five year Series A common share purchase warrant to purchase one half of a share of common stock at an exercise price of $2.50
per whole share and a two year Series B common share purchase warrant to purchase one half of a share of common stock at an exercise
price of $2.50 per whole share. In February 2011, the Company also issued to the placement agents 96,000 warrants to purchase a whole
share of common stock at an exercise price of $3.125 per whole share.
Under U.S. GAAP, when the strike price of warrants is denominated in a currency other than an entity's functional currency, the
warrants would not be considered indexed to the entity’s own stock. As a result, the Company determined that these warrants are not
considered indexed to the Company’s own stock and therefore would consequently be considered to be derivative liability. Also under U.S.
GAAP, warrants with the cashless exercise option satisfying the explicit net settlement criteria are considered a derivative liability.
In January 2013, the Company completed the private placement financing of an unsecured Debenture in the principal amount of
$1.5 million. The Debenture (which was to mature on January 1, 2015, was extended on October 1, 2014 to July 1, 2015), bears interest at a
rate of 12% per annum, payable monthly, is pre-payable at any time at the option of the Company, and is convertible at any time into
500,000 common shares at a conversion price of $3.00 per common share at the option of the holder. The conversion price of the
Debenture is in U.S. dollars and the Company’s functional currency in fiscal 2013 was the Canadian dollar. Under U.S. GAAP, when the
conversion price of the Debenture is denominated in a currency other than an entity's functional currency, the conversion option meets the
definition of an embedded derivative. The conversion option is bifurcated from its host contract and the fair value of the conversion option
characterized as an embedded derivative upon issuance. The embedded derivative is presented on a combined basis with the host contract.
The derivative is re-measured at the end of every
-41-
reporting period with the change in value reported in the consolidated statements of operations and comprehensive loss.
U.S. GAAP requires the fair value of these liabilities be re-valued at the end of every reporting period with the change in value
reported in the consolidated statements of operations and comprehensive loss. Accordingly, the fair values of the warrant derivative
liabilities from the Series A, Placement Agents, March 2013 and July 2013 Warrants, and conversion option embedded derivative from the
Debenture have been re-valued at November 30, 2013 using the Black-Scholes Option Pricing Model, resulting in an increase in the fair
value of the derivative liabilities and a fair value adjustment of the derivative liabilities for a loss of $3,889,683.
Financing Expense
Financing expense was $115,056 for the year ended November 30, 2013 compared to $Nil for the prior year. This expense was
related to the March 2013 registered direct unit offering for gross proceeds of $3.1 million and the July 2013 underwritten public offering
of units for gross proceeds of $3.1 million. These costs were expensed as they were attributable to the warrant liability. In March 2012 the
Company closed a registered direct common share offering for gross proceeds of $5 million; for this financing the costs were recorded in
shareholder equity.
Foreign Exchange Gain (Loss)
Foreign exchange loss was $359,554 for the year ended November 30, 2013 in comparison to a gain of $181,682 for the prior
year. The foreign exchange loss for the year ended November 30, 2013 was due to the weakening of the Canadian dollar against the U.S.
dollar throughout the year as the exchange rate averaged $1.00 for C$1.0241 compared to $1.00 for C$0.9977 for prior year. Based on year
end dates, the Canadian dollar weakened against the U.S. dollar as the exchange rates changed to $1.00 for C$1.0620 at November 30,
2013 from $1.00 for C$0.9936 at November 30, 2012.
Interest Income
Interest income was $2,839 for the year ended November 30, 2013 in comparison to $20,691 for the year ended November 30,
2012, a decrease of $17,852. In the year ended November 30, 2013, interest was lower largely due to a lower average amount of cash
equivalents on hand during 2013.
Interest Expense
Interest expense was $314,896 for the year ended November 30, 2013 in comparison to $63,406 for the year ended November 30,
2012, an increase of $251,490. On January 10, 2013 we issued the $1,500,000 Debenture, which accrued interest payable at 12% annually.
Also, the Debenture proceeds of $1.5 million less the initial fair value of the conversion option embedded derivative of $220,100, amounts
to $1,279,900 and are accreted at an annual imputed interest rate of 8%, over the life of the Debenture. We continued to have another
related party loan outstanding which accrues interest at 6% annually during 2013 and 2012. In the year ended November 30, 2014, the
entire outstanding related party loan principal in the amount of $665,226 (C$736,685) was repaid and an interest payment of $48,545
(C$53,762) was made.
B.
Liquidity and Capital Resources
The Company had cash of $4,233,975 as at November 30, 2014 compared to $760,586 as at November 30, 2013 and compared to
$497,016 as at November 30, 2012. The increase in cash during the year ended November 30, 2014 is mainly a result of the decrease in
cash flows used in operating activities due to payments received from the commercial sales of our generic Focalin XR®
(dexmethylphenidate hydrochloride extended-release) capsules for the 15 and 30 mg strengths, cash flows from financing activities which
are mainly from our at-the-market financing and several warrant exercise, and partially offset by an increase in purchases of production,
laboratory and computer equipment. The increase in cash during the year ended November 30, 2013 is mainly a result of an increase in
financing activities, partially offset by a decrease in cash flows used in operating activities related to R&D activities, and the decrease in
purchases of production, laboratory and computer equipment, as noted below. The decrease in cash during the year ended November 30,
2012 is mainly a result of cash flows used in operating activities related to R&D activities and the purchase of production, laboratory and
computer equipment due to the acceleration of product development activities, as noted below.
For the year ended November 30, 2014, net cash flows used in operating activities decreased to $1,714,913 as compared to net
cash flows used in operating activities for the years ended November 30, 2013 and 2012 of $6,926,796 and $7,654,361, respectively. The
November 30, 2014 decrease was due to the receipt of payment of
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$8,465,466, relating to commercial sales of dexmethylphenidate hydrochloride extended-release capsules by Par for the 15 and 30 mg
strengths of the drug product for the year ended November 30, 2014, under the Par agreement. Also, in the year ended November 30, 2014,
the Company received $395,835 under the Par agreement as a milestone payment tied to the achievement of our product being either the
only generic in the market or having only one generic competitor, which was partially offset by increased R&D expenses, increased selling,
general and administrative expenses, and payment of the outstanding salaries payable in the amount of $336,327 to Dr. Isa Odidi and Dr.
Amina Odidi, principal shareholders, directors and executive officers of the Company.
Research and development costs, which are a significant portion of the cash flows used in operating activities, related to continued
internal research and development programs are expensed as incurred. However, equipment and supplies are capitalized and amortized over
their useful lives if they have alternative future uses. For the years ended November 30, 2014, 2013, and 2012, R&D expense was $
8,020,201, $5,076,236, and $5,992,417, respectively. For the years ended November 30, 2014, 2013, and 2012, R&D expense before stock
option expense was $6,749,894, $4,239,030, and $4,487,356, respectively.
As a research and development company, Intellipharmaceutics Corp., a wholly-owned subsidiary of the Company (“IPC Corp”) is
eligible to receive ITCs from various levels of government under the SR&ED incentive programs. Depending on the financial condition of
IPC Corp, research and development expenses in any fiscal year could be claimed. Eligible research and development expenses included
salaries for employees involved in research and development, cost of materials, equipment purchase as well as third party contract services.
This amount is not a reduction in income taxes but a form of government refundable credits based on the level of research and development
that the Company carries out.
In fiscal year 2013 and 2012, the Company received C$300,000 in each year for the ITCs with the Ontario Ministry of Finance for
research and development activities carried out during the fiscal years 2012 and 2011, respectively.
Net cash flows provided from financing activities for the year ended November 30, 2014 of $5,957,275 related principally from
our at-the-market issuances of 1,689,500 common shares sold on NASDAQ for gross proceeds of $6,571,673 with net proceeds to us of
$6,390,952. For the year ended November 30, 2013, net cash flows provided from financing activities of $7,328,420 related principally to
the July 2013 underwritten public offering for gross proceeds of approximately $3.1 million, the March 2013 registered direct unit offering
for gross proceeds of approximately $3.1 million, the January 2013 Debenture financing in the principal amount of $1.5 million, and
warrant exercises, offset by issuance costs. For the year ended November 30, 2012, net cash flows provided from financing activities of
$4,363,865 related principally to the registered direct common share offering for gross proceeds of $5 million completed in March 2012,
and warrant exercises, partially offset by issuance costs.
As at November 30, 2014, we had repaid the entire outstanding principal amount of a related party loan to Dr. Isa Odidi and Dr.
Amina Odidi, our principal stockholders, directors and executive officers, in the amount of $690,049 (C$764,851) out of licensing revenues
earned by IPC Corp and made interest payments of $48,504 (C$53,762) in accordance with the IPC Arrangement Agreement.
For the year ended November 30, 2014, net cash flows used in investing activities of $768,973 related mainly to the purchases of
production, laboratory and computer equipment due to the acceleration of product development activities. For the year ended November
30, 2013, net cash flows used in investing activities of $122,017 related mainly to the purchase of production and laboratory equipment For
the year ended November 30, 2012, net cash flows used in investing activities of $1,036,092 related mainly to the purchase of production,
laboratory and computer equipment due to the acceleration of product development activities.
All non-cash items have been eliminated from the consolidated statements of cash flows.
Other than the net income for the three months ending February 28, 2014, the Company has incurred losses from operations since
inception. To date, the Company has funded its research and development activities principally through the issuance of securities, loans
from related parties, funds from the IPC Arrangement Agreement and funds received under development agreements. To a lesser extent,
since November 2013, research has also been funded from revenues from sales of our dexmethylphenidate hydrochloride extended-release
capsules for the 15 and 30 mg strengths. Currently, the Company does not anticipate generating sufficient cash flows from operations as it
pursues the development of its portfolio of ANDA and NDA 505(b)(2) product candidates. Our
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future operations are highly dependent upon our ability to raise additional capital to support advancing our product pipeline through
continued research and development activities. Although there can be no assurances, such financing may come from proceeds of the
Company’s at-the-market offering program, from sales of our generic Focalin XR ® (dexmethylphenidate hydrochloride extended-release)
capsules and from potential partnering opportunities. Our ultimate success will depend on whether our product candidates receive the
approval of the FDA or other applicable regulatory agencies and we are able to successfully market approved products. We cannot be
certain that we will be able to receive FDA approval for any of our current or future product candidates, or that we will reach the level of
sales and revenues necessary to achieve and sustain profitability.
The Company received final approval from the FDA in November 2013 to launch generic Focalin XR® (dexmethylphenidate
hydrochloride extended-release) capsules for the 15 and 30 mg strengths. Commercial sales of these strengths were launched immediately
by our commercialization partner in the United States, Par. As the first-filer for the drug product in the 15 mg strength, we had 180 days
(up to May 19, 2014) of exclusivity of sales for the generic product of that strength from the date of launch on November 19, 2013 in the
United States by our partner, Par. Our 5, 10, 20 and 40 mg strengths were also tentatively FDA approved, subject to the right of another
party or parties to 180 days of generic exclusivity from the date of first launch of such products by such parties. We also believe that Teva
launched their own 5 mg strength of generic Focalin XR® capsules on November 11, 2014. We believe that Par intends to launch the 5mg
strength in May 2015, upon the expiry of the exclusivity period, but there can be no assurance as to when or if the launch will occur. There
can be no assurance as to when or if final FDA approval will be received for the remaining product strengths we have applied for or that
any of these strengths tentatively approved will ever be successfully commercialized.
As of February 23, 2015, we had a cash balance of $4.4 million, which we expect will fund our currently projected operations
through May 2015. In order for us to continue operations at currently projected levels beyond May 2015, we will be required to seek
significant additional capital. We might also need further additional capital to fund any R&D activities which are at higher-than-currently
projected levels and to fund any significant expansion of our operations. Although there can be no assurances, such capital may come from
proceeds of the Company’s at-the-market offering program, from revenues from the sales of our generic Focalin XR® (dexmethylphenidate
hydrochloride extended-release) capsules, and from potential partnering opportunities. Other potential sources of capital may include
payments from licensing agreements, cost savings associated with managing operating expense levels, other equity and/or debt financings,
and/or new strategic partnership agreements which fund some or all costs of product development, although there can be no assurance that
we will be able to obtain any such capital on terms or in amounts sufficient to meet our needs or at all.
The increase in expenses in 2014 was in part as a result of capital expenditures on production and analytical equipment and
expenses for the procurement of active raw materials, conducting clinical studies and, to a lesser extent, hiring of additional personnel.
Our cash requirements for R&D during any period depend on the number and extent of the R&D activities we focus on. At
present, we are working principally on our oxycodone and pregabalin 505(b)(2), and selected generic, product candidate development
projects. For the 505(b)(2) product candidates, clinical trials beyond Phase I can be capital intensive, and will only be undertaken consistent
with the availability of funds and a prudent cash management strategy. We do not anticipate any material equipment purchases in the next
twelve months in the absence of significant additional funding.
Effective October 1, 2014, the January 1, 2015 maturity date for the Debenture in respect of the $1,500,000 loan to the Company
by Drs. Isa and Amina Odidi was extended to July 1, 2015. The Company currently expects to repay this amount from then available cash
on or about July 1, 2015.
Our ultimate success will depend on whether our product candidates receive the approval of the FDA or other applicable
regulatory agencies and we are able to successfully market approved products. We cannot be certain that we will be able to receive FDA
approval for any of our current or future product candidates, or that we will reach the level of sales and revenues necessary to achieve and
sustain profitability. The availability of equity or debt financing will be affected by, among other things, the results of our research and
development, our ability to obtain regulatory approvals, the market acceptance of our products, the state of the capital markets generally,
strategic alliance agreements, and other relevant commercial considerations. In addition, if we raise additional funds by issuing equity
securities, our then existing security holders will likely experience dilution, and the incurring of indebtedness would result in increased debt
service obligations and could require us to agree to operating and
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financial covenants that would restrict our operations. In the event that we do not obtain sufficient additional capital, there may be
substantial doubt about our ability to continue as a going concern and realize our assets and pay our liabilities as they become due.
Depending upon the results of our research and development programs and the availability of financial resources, we could decide to
accelerate, terminate, or reduce certain projects, or commence new ones. Any failure on our part to raise additional funds on terms
favorable to us or at all, may require us to significantly change or curtail our current or planned operations in order to conserve cash until
such time, if ever, that sufficient proceeds from operations are generated, and could result in our not taking advantage of business
opportunities, in the termination or delay of clinical trials or our not taking any necessary actions required by the FDA for one or more of
our product candidates, in curtailment of our product development programs designed to identify new product candidates, in the sale or
assignment of rights to our technologies, products or product candidates, and/or our inability to file ANDAs or NDAs at all or in time to
competitively market our products or product candidates.
C.
Research and development, patents, and licenses, etc.
We expense R&D costs. For the years ended November 30, 2014, 2013 and 2012, R&D expense was $8,020,201, $5,076,236and
$5,992,417, respectively.
D.
Trend Information
It is important to note that historical patterns of revenue and expenditures cannot be taken as an indication of future revenue and
expenditures. Net income and loss has been variable over the last eight quarters, and has been impacted primarily by the FDA approval and
commercial sales of generic Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules for the 15 and 30 mg strengths,
availability of funding, the level of our R&D spending, and the fair value adjustment of derivative liabilities. The net loss in the third and
fourth quarter of 2014 is attributed to the ongoing R&D and selling, general and administrative expense, as well as the expiry of the
exclusivity period for the 15mg strength of dexmethylphenidate hydrochloride extended-release capsules in the third quarter, allowing
more competitors into the market, which negatively impacted our licensing revenue from dexmethylphenidate hydrochloride extended-
release capsules. The net income in the second quarter of 2014 is attributed to the licensing and milestone revenue of $4.7 million from
dexmethylphenidate hydrochloride extended-release capsules and the change in functional currency eliminating fair value adjustments of
derivative liabilities. The higher net income in the first quarter of 2014 is attributed to the licensing revenue from dexmethylphenidate
hydrochloride extended-release capsules plus milestone revenue received under the Par agreement. As the first-filer for the drug product in
the 15 mg strength, we had 180 days (up to May 19, 2014) of exclusivity of sales for the generic product of that strength from the date of
launch on November 19, 2013 in the United States by our partner, Par. The higher net loss during the fourth quarter of 2013 when
compared to the net loss in the third quarter of 2013 can be mainly attributed to the fair value adjustment of derivative liabilities for a loss
of $5.1 million due to the significant increase in common share price driving the fair market valuation of derivate liabilities. This loss
partially offset by the timing of certain R&D activities which have been deferred, and licensing revenue of $1.5 million related to
commercial sales of generic Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules for the 15 and 30 mg strengths
under the Par agreement. The increase in the Company’s net loss for the third quarter ended August 31, 2013, as compared to the
Company’s net loss for the second quarter ended May 31, 2013, can be attributed to the loss of $0.2 million in the fair value adjustment of
derivative liabilities. In contrast, for the second quarter ended May 31, 2013, there was a gain of $0.2 million in the fair value adjustment
of derivative liabilities.
The following selected financial information is derived from our unaudited interim consolidated financial statements.
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Quarter Ended
Revenue Net (loss) income
(Loss) income per share
November 30, 2014
August 31, 2014
May 31, 2014
February 28, 2014
November 30, 2013
August 31, 2013
May 31, 2013
February 28, 2013
Basic(1)
Diluted(1)
$
1,536,990
1,072,703
1,478,942
4,681,058
1,527,474
-
-
-
$
(1,247,105)
(1,670,407)
(3,140,275)
2,201,435
(6,325,439)
(2,047,783)
(1,781,662)
(1,340,133)
$
(0.05)
(0.07)
(0.14)
0.10
(0.30)
(0.10)
(0.09)
(0.07)
$
(0.05)
(0.07)
(0.14)
0.09
(0.30)
(0.10)
(0.09)
(0.07)
(1) Quarterly per share amounts may not sum due to rounding.
E.
Off-balance sheet arrangements
The Company, as part of its ongoing business, does not participate in transactions that generate relationships with unconsolidated
entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities (“SPE”), which would
have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. As
of November 30, 2014, the Company was not involved in any material unconsolidated SPE transactions.
F.
Tabular disclosure of contractual obligations
In the table below, we set forth our enforceable and legally binding obligations and future commitments and obligations related to
all contracts. Some of the figures we include in this table are based on management’s estimate and assumptions about these obligations,
including their duration, the possibility of renewal, anticipated actions by third parties, and other factors. The Company has entered into
capital lease agreements for laboratory equipment where the lease obligation will end in fiscal 2017. Operating lease obligations relate to
the lease of premises which will expire in November 2015, with an option to extend the lease for five additional years on terms we
currently believe to be favourable.
Contractual Obligations
Third parties
Accounts payable
Accrued liabilities
Capital lease
Operating lease
Related parties
Employee costs payable
Convertible debenture
Total contractual obligations
G.
Safe Harbor
Payments Due by Period
Total
$
Less than 1
Year
$
1 - 3 Years
$
3 - 5 Years
$
More than 5
Years
$
668,069
675,487
63,609
78,308
668,069
675,487
21,449
78,308
181,204
1,603,983
3,270,660
181,204
1,603,983
3,228,500
-
-
42,160
-
-
-
42,160
-
-
-
-
-
-
-
-
-
-
-
-
-
-
See “Disclosure Regarding Forward-Looking Information” in the introduction to this annual report.
Item 6.
Directors, Senior Management and Employees
A.
Directors and Senior Management
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DIRECTORS AND OFFICERS
The name and province/state of residence of each of our directors and officers as at the date hereof, the office presently held, principal
occupation, and the year each director first became a director of the Company or its predecessor, IPC Ltd., are set out below. Each director
is elected to serve until the next annual meeting of our shareholders or until his or her successor is elected or appointed. Officers are
appointed annually and serve at the discretion of the board of directors (the “Board”).
Name and Province of
Residence
Dr. Isa Odidi
Ontario, Canada
Dr. Amina Odidi
Ontario, Canada
John Allport(2)
Ontario, Canada
Dr. Eldon R. Smith (1) (2)
Alberta, Canada
Position held with the Company
Chairman of the Board and Chief
Executive Officer
President, Chief Operating Officer and
Director
Vice-President, Legal Affairs and
Licensing and Director
Director
Bahadur Madhani (1) Ontario,
Canada
Director
Kenneth Keirstead (1)(2) New
Brunswick, Canada
Dr. Patrick Yat
Ontario, Canada
Domenic Della Penna (3)
Ontario, Canada
Director
Vice-President, Pharmaceutical
Analysis and Chemistry
Chief Financial Officer
Director
Since
September
2004
September
2004
September
2004
October
2009
March 2006
January
2006
N/A
N/A
Principal Occupations During
the Last 5 Years
Officer of the Company
Other Public
Company Boards
None
Officer of the Company
Officer of the Company
None
None
Aston Hill
Financial;
Canadian Natural
Resources Limited;
Resverlogix Corp;
Zenith Epigenetics
Corp.
None
None
None
None
President and CEO of Eldon R.
Smith and Associates Ltd., a
consulting business and Professor
Emeritus at the University of
Calgary, Faculty of Medicine
Chief Executive Officer of
Equiprop Management Limited, a
consulting business.
Executive Manager of Lyceum
Group, a consulting business.
Officer of the Company
Officer of the Company since
November 24, 2014; Chief
Financial Officer (Interim) of Teva
North America Generics from
December 2013 to September
2014; Chief Financial Officer of
Teva Canada Limited from
December 2010 to September
2014; Chief Financial Officer of
Timothy’s Coffees of the World
from 2008-2010.
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Notes:
1. Member of the Audit Committee and Compensation Committee.
2. Member of the Corporate Governance Committee.
3. Mr. Della Penna was appointed as Chief Financial Officer of the Company effective November 24, 2014. Shameze Rampertab had
served as the Company’s Vice President and Chief Financial Officer from November 2010 until his resignation effective on October 10,
2014. Dr. Amina Odidi, the Company’s President and former Chief Financial Officer, carried out the functions of Chief Financial
Officer from the date of Mr. Rampertab’s resignation until Mr. Della Penna was appointed as Chief Financial Officer.
Each of the foregoing individuals named in the above table has been engaged in the principal occupation set forth opposite his or her name
during the past five years.
As of February 23, 2015, the directors and executive officers of the Company as a group owned, directly and indirectly, or
exercise control or direction over 6,163,147 common shares, representing approximately 26.3% of the issued and outstanding common
shares of the Company (and beneficially owned approximately 9,884,011 common shares representing 36.4%of our common shares
including common shares issuable upon the exercise of outstanding options and the conversion of the outstanding convertible debenture
that are exercisable or convertible within 60 days of the date hereof). Our principal shareholders, Drs. Amina and Isa Odidi, our President
and Chief Operating Officer and our Chairman and Chief Executive Officer, respectively, and Odidi Holdings Inc., a privately-held
company controlled by Drs. Amina and Isa Odidi, owned in the aggregate directly and indirectly 5,997,751 common shares, representing
approximately 25.5% of our issued and outstanding common shares of the Company (and collectively beneficially owned in the aggregate
approximately 9,006,115 common shares representing 34.0% of our common shares including common shares issuable upon the exercise of
outstanding options and the conversion of the outstanding convertible debenture that are exercisable or convertible within 60 days of the
date hereof). (Reference is made to the section entitled “E. Share Ownership” under this “Item 6. Directors, Senior Management and
Employees” for additional information regarding the options to purchase common shares held by directors and officers of the Company
and the convertible debenture held by Drs. Amina and Isa Odidi.) As a result, the principal shareholders will have the ability to exercise
significant influence over all matters submitted to our shareholders for approval whether subject to approval by a majority of holders of our
common shares or subject to a class vote or special resolution requiring the approval of 66⅔% of the votes cast by holders of our common
shares, in person or by proxy.
On June 25, 2004, Mr. Keirstead filed a voluntary assignment in bankruptcy and was issued a discharge on September 23, 2006.
Drs. Isa Odidi and Amina Odidi are spouses to each other.
B.
Compensation
Compensation Discussion and Analysis
Background – We are a pharmaceutical company specializing in the research, development and manufacture of novel and generic
controlled-release and targeted-release oral solid dosage drugs. Our patented Hypermatrix™ technology is a multidimensional controlled-
release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based
on this technology platform, we have developed several drug delivery systems and a pipeline of products (our dexmethylphenidate
hydrochloride extended-release capsules for the 15 and 30 mg strengths which received final FDA approval) and product candidates in
various stages of development, including ANDAs filed with the FDA in therapeutic areas that include neurology, cardiovascular, GIT,
diabetes and pain. Several of these products are partnered. As of November 30, 2014, the Company had 46 full-time employees engaged in
administration and research and development.
Compensation Governance - The Company’s Compensation Committee is comprised of three directors, Messrs. Madhani,
Keirstead and Smith, each of whom is considered “independent” within the meaning of section 2.4 of Form 51-102F6 – Statement of
Executive Compensation. Each member of the Compensation Committee has sufficient experience in order to make decisions on the
suitability of the Company’s compensation policies and practices.
The Compensation Committee recommends compensation policies concerning officers and senior management to the Board. The
Corporate Governance Committee recommends compensation policies concerning
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independent directors to the Board. The Board makes the final determinations regarding the adequacy and form of the compensation for
non-executive directors to ensure that such compensation realistically reflects the responsibilities and risks involved, without compromising
a director’s independence. Further details relating to the role and function of the Compensation Committee and the Corporate Governance
Committee is provided in Item 6.C.
Risk Management - The Board is responsible for identifying the principal risks of the Company’s business and ensuring the
implementation of appropriate systems to manage these risks. Through the Compensation Committee, the Board is involved in the design of
compensation policies to meet the specific compensation objectives discussed below and considers the risks relating to such policies, if any.
The Compensation Committee is ultimately responsible for ensuring compliance of the compensation policies and practices of the
Company. To date, the Board and Compensation Committee have not identified any risks arising from the Company’s compensation
policies and practices that would be reasonably likely to have a material adverse effect on the Company.
Objectives - The overall objectives of the Company’s compensation program include: (a) attracting and retaining talented
executive officers; (b) aligning the interests of those executive officers with those of the Company; and (c) linking individual executive
officer compensation to the performance of the Company. The Company’s compensation program is currently designed to compensate
executive officers for performance of their duties and to reward certain executive officers for performance relative to certain milestones
applicable to their services.
Elements of Compensation - The elements of compensation awarded to, earned by, paid to, or payable to the Named Executive
Officers (as hereinafter defined) for the most recently completed financial year are: (a) base salary and discretionary bonuses; (b) long-term
incentives in the form of stock options; (c) restricted and deferred share unit awards; and (d) perquisites and personal benefits. Prior to the
most recently completed financial year, the Named Executive Officers have also received option-based awards which were assumed by the
Company pursuant to the plan of arrangement completed on October 22, 2009.
Base Salary - Base salary is a fixed element of compensation payable to each Named Executive Officer for performing his or her
position’s specific duties. The amount of base salary for a Named Executive Officer has been determined through negotiation of an
employment agreement with each Named Executive Officer (see “Employment Agreements” below). While base salary is intended to fit
into the Company’s overall compensation objectives by serving to attract and retain talented executive officers, the size of the Company
and the nature and stage of its business also impact the level of base salary. To date, the level of base salary has not impacted the
Company’s decisions about any other element of compensation.
Option-Based Awards - Option-based awards are a variable element of compensation that rewards each Named Executive Officer
for individual and corporate performance overall determined by the Board. Option-based awards are intended to fit into the Company’s
overall compensation objectives by aligning the interests of all Named Executive Officers with those of the Company, and linking
individual Named Executive Officer compensation to the performance of the Company. The Board, which includes three of the five
Named Executive Officers, is responsible for setting and amending any equity incentive plan under which an option-based award is granted.
The Company has in place a stock option plan (the “Option Plan”) for the benefit of certain officers, directors, employees and
consultants of the Company, including the Named Executive Officers (as described in greater detail in Item 6.E below). Named Executive
Officers have been issued options under such plan. The Company has also granted performance-based options to Dr. Isa Odidi and Dr.
Amina Odidi pursuant to a separate option agreement, which was negotiated at the same time as their employment agreements. These
options vest upon the Company attaining certain milestones relating to FDA filings and approvals for Company drugs, such that 276,394
options vest in connection with each of the FDA filings for the first five Company drugs and 276,394 options vest in connection with each
of the FDA approvals for the first five Company drugs.
The Company’s Option Plan was adopted effective October 22, 2009 as part of the IPC Arrangement Agreement approved by the
shareholders of IPC Ltd., the predecessor company, at the meeting of shareholders on October 19, 2009. Subject to the requirements of the
Option Plan, the Board, with the assistance of the Compensation Committee, has the authority to select those directors, officers, employees
and consultants to whom options will be granted, the number of options to be granted to each person and the price at which common shares
of
-49-
the Company may be purchased. Grants are determined based on individual and aggregate performance as determined by the Board.
RSUs - The Company established a restricted share unit plan (the “RSU Plan”) to form part of its incentive compensation
arrangements available for officers and employees of the Company and its designated affiliates (as described in greater detail it Item 6.E) as
of May 28, 2010, when the RSU Plan received shareholder approval.
Perquisites and personal benefits - The Company also provides perquisites and personal benefits to its Named Executive Officers,
including basic employee benefit plans, which are available to all employees, and a car allowance to cover the cost of an automobile for
business purposes. These perquisites and personal benefits were determined through negotiation of an employment agreement with each
Named Executive Officer (see “Employment Agreements” below). While perquisites and personal benefits are intended to fit into the
Company’s overall compensation objectives by serving to attract and retain talented executive officers, the size of the Company and the
nature and stage of its business also impact the level of perquisites and benefits. To date, the level of perquisites and benefits has not
impacted the Company’s decisions about any other element of compensation.
Other Compensation-Related Matters - The Company’s Share Trading Policy prohibits all directors and officers of the Company
from, among other things, engaging in any short sales designed to hedge or offset a decrease in market value of the securities of the
Company.
Executive Compensation
The following table sets forth all direct and indirect compensation for, or in connection with, services provided to the Company
for the financial years ended November 30, 2014, November 30, 2013 and November 30, 2012 in respect of the Chief Executive Officer of
the Company, the Chief Operating Officer of the Company, the Chief Financial Officer, the former Chief Financial Officer and two other
officers of the Company who earned greater than $150,000 in total compensation in the fiscal year ended November 30, 2014 (“Named
Executive Officers”).
SUMMARY COMPENSATION TABLE
Name and principal
position
(a)
Salary
(U.S.$)(1)
(c)
Share-based
awards
(U.S.$)
(d)
Year
(b)
Option-
based
awards
(U.S.$)(2)
(e)
Non-equity incentive
plan compensation
(U.S.$)
(f)
Pension
value
(U.S.$)
(g)
All other
compensation
(U.S.$) (4)
(h)
Total
compensation
(U.S.$)
(i)
Dr. Isa Odidi, Chairman &
Chief Executive Officer
Dr. Amina Odidi, President
& Chief Operating Officer
2014
581,965
2013
509,716
2012
454,912
2014
581,965
2013
509,716
2012
454,912
Shameze Rampertab,
Former VP Finance &
Chief Financial Officer(5)
2014
208,884
2013
244,117
John Allport, VP Legal
Affairs & Licensing
2012
251,610
2014
132,167
2013
141,588
2012
145,934
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Annual
incentive
plans(3)
99,615
182,299
Long-
term
incentive
plans
N/A
368,832
701,741
N/A
N/A
N/A
N/A
99,615
182,299
N/A
368,832
701,741
N/A
N/A
N/A
N/A
58,293
91,149
N/A
81,645
70,857
N/A
52,049
N/A
N/A
99,615
91,149
N/A
68,922
589,411
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
10,938
11,718
775,202
890,266
12,077
1,168,730
10,938
11,718
775,202
890,266
12,077
1,168,730
9,571
367,897
11,718
12,077
10,938
11,718
12,077
337,480
315,736
333,869
222,227
747,422
Domenic Della Penna,
Chief Financial Officer(6)
2014
5,222
N/A
34,573
N/A
N/A
N/A
342
40,137
-50-
Notes:
(1) Salaries paid by the Company to each Named Executive Officer are paid in Canadian dollars. All amounts are expressed in U.S. dollars
converted at the exchange rate of U.S.$0.9115 to C$1.00 (2013 – U.S.$ 0.9765; 2012 – U.S.$ 1.0064) being the average closing
exchange rate quoted by the Bank of Canada for the respective periods. Salary includes all amounts paid or payable to the Named
Executive Officer. Actual amount paid to each Named Executive Officer in fiscal 2014, 2013 and 2012 are as disclosed in the table.
During the year ended November 30, 2014, the Company paid U.S. $336,327 in salary to Dr. Isa Odidi and Dr. Amina Odidi, related to
years prior to 2010.
(2) The Company entered into a separate acknowledgement and agreement with Drs. Isa and Amina Odidi dated October 22, 2009 to be
bound by the performance-based stock option agreement dated September 10, 2004 pursuant to which Drs. Isa and Amina Odidi are
entitled to purchase up to 2,763,940 of the Company’s common shares upon payment of U.S. $3.62 per share, subject to satisfaction of
the performance vesting conditions. The value of the option-based awards are determined using the Black-Scholes pricing model
calculated as at the award date.
(3) Amount awarded at the discretion of the Board. This bonus was paid in the second quarter of 2014 and first quarter of 2012.
(4) “All other compensation” includes car allowances and other miscellaneous benefits.
(5) Mr. Rampertab served as the Company’s Vice President and Chief Financial Officer from November 2010 until his resignation
effective on October 10, 2014.
(6) Mr. Della Penna was appointed as Chief Financial Officer of the Company effective November 24, 2014.
Significant factors necessary to understand the information disclosed in the Summary Compensation Table above include the
terms of each Named Executive Officer’s employment agreement and the terms of the separate option agreement described below.
Employment Agreements
The employment agreement with Dr. Isa Odidi, the Chief Executive Officer of the Company, effective September 1, 2004 entitles
Dr. Isa Odidi to receive a base salary of U.S.$200,000 per year, which is paid in Canadian dollars, to be increased annually each year during
the term of the agreement by twenty percent of the prior year’s salary. In addition, he is entitled to: (a) participate in the Option Plan; (b)
participate in all employee benefit plans and programs, except for the RSU Plan and DSU Plan; and (c) a car allowance of up to U.S. $1,000
per month. The initial term of the employment agreement was until September 30, 2007, at which time, pursuant to the terms of the
agreement, the agreement was deemed to be extended automatically for an additional three-year period on the same terms and conditions
(i.e. until September 30, 2010). The agreement will continue to be extended automatically for successive additional three-year periods on
the same terms unless the Company gives Dr. Odidi contrary written notice at least two years prior to the date on which the agreement
would otherwise be extended. See “Termination and Change of Control Benefits” below. Dr. Odidi’s employment agreement was amended
on August 1, 2007 and June 8, 2009 to include intellectual property, non-competition and non-solicitation provisions in favour of the
Company. In April 2010, Dr. Isa Odidi offered and agreed to amend his employment agreement effective as of December 1, 2009, to
eliminate the right to annual increases in his base salary of twenty per cent each year; and agreed to roll back his base salary effective
December 1, 2009 to the level payable under the employment agreement for the period from September 2008 to August 2009, being
C$452,000 per year. Under this amendment, the base salary is open to potential increase on an annual basis at the discretion of the Board
and Dr. Isa Odidi is eligible to receive a performance bonus, based on the performance, including that of Dr. Odidi and the Company, as
may be determined in the discretion of the Board. In February 2012, Dr. Isa Odidi received a grant of 300,000 options of which 200,000
vested immediately on issuance and the remaining 100,000 options vested on February 17, 2013. In April 2013, Dr. Isa Odidi received a
grant of 75,000 options of which 37,500 vested immediately on issuance and the remaining 37,500 options vested on November 30, 2013.
In March 2014, Dr. Isa Odidi received a grant of 50,000 options of which 25,000 vested immediately on issuance and the remaining 25,000
options vested on November 30, 2014.
The employment agreement with Dr. Amina Odidi, the President and Chief Operating Officer of the Company, effective
September 1, 2004 entitles Dr. Amina Odidi to receive a base salary of U.S.$200,000, which is paid in Canadian dollars, per year, to be
increased annually each year during the term of the agreement by twenty percent of the prior year’s salary. In addition, she is entitled to: (a)
participate in the Option Plan; (b) participate in all employee benefit plans and programs, except for the RSU Plan and DSU Plan; and (c) a
car allowance of up to U.S.$1,000 per month. The initial term of the employment agreement was until September 30, 2007, at which time,
pursuant to the terms of the agreement, the agreement was deemed to be extended automatically for an additional three-year period on the
same terms and conditions (i.e. until September 30, 2010). The agreement will continue to be extended automatically for successive
additional three-year periods on the same terms unless the Company gives
-51-
Dr. Odidi contrary written notice at least two years prior to the date on which the agreement would otherwise be extended. See
“Termination and Change of Control Benefits” below. Dr. Odidi’s employment agreement was amended on August 1, 2007 and June 8,
2009 to include intellectual property, non-competition and non-solicitation provisions in favour of the Company. In April 2010, Dr. Amina
Odidi offered and agreed to amend her employment agreement effective as of December 1, 2009, to eliminate the right to annual increases
in her base salary of twenty per cent each year; and agreed to roll back her base salary effective December 1, 2009 to the level payable
under the employment agreement for the period from September 2008 to August 2009, being C$452,000 per year. Under this amendment,
the base salary is open to potential increase on an annual basis at the discretion of the Board and Dr. Amina Odidi is eligible to receive a
performance bonus, based on the performance, including that of Dr. Odidi and the Company, as may be determined in the discretion of the
Board. In February 2012, Dr. Amina Odidi received a grant of 300,000 options of which 200,000 vested immediately on issuance and the
remaining 100,000 options vested on February 17, 2013. In April 2013, Dr. Amina Odidi received a grant of 75,000 options of which
37,500 vested immediately on issuance and the remaining 37,500 options vested on November 30, 2013. In March 2014, Dr. Amina Odidi
received a grant of 50,000 options of which 25,000 vested immediately on issuance and the remaining 25,000 options vested on November
30, 2014.
In addition, the Company entered into a separate acknowledgement and agreement with Drs. Isa and Amina Odidi dated October
22, 2009 to be bound by the performance-based stock option agreement dated September 10, 2004 pursuant to which Drs. Isa and Amina
Odidi are entitled to purchase up to 2,763,940 of the Company’s common shares. These options vest upon the Company attaining certain
milestones related to the FDA filings and approvals for Company drugs. The options are exercisable at a price of U.S.$3.62 per share and
were to expire in September 2014. Effective March 27, 2014, the Company’s shareholders approved a two year extension of the
performance-based stock option expiry date to September 2016. As of the date hereof, 1,658,364 of these options have vested and are
exercisable. These options were not granted under the Option Plan.
Shameze Rampertab had served as the Company’s Chief Financial Officer from November 2010 until his resignation effective on
October 10, 2014. The employment agreement with Mr. Rampertab, effective November 29, 2010 provided for Mr. Rampertab to receive a
base salary of C$180,000, which was paid in Canadian dollars, per year. In addition, he was entitled to: (a) participate in the Option Plan;
(b) participate in all employee benefit plans and programs; and (c) a car allowance of C$1,000 per month. The agreement provided for
automatic renewal from year to year in absence of notice of termination from the Company at least 60 days prior to the anniversary date.
Mr. Rampertab was granted 60,000 options, of which 15,000 vested immediately on issuance and the remaining options vested as to 15,000
each year on November 29, 2011, 2012 and 2013. The agreement was extended and entitled Mr. Rampertab to receive a base salary of
C$250,000, which is paid in Canadian dollars, per year, and a grant of 40,000 options, which vest 13,334 each year on February 16, 2013,
2014 and 2015. Mr. Rampertab’s employment agreement included intellectual property, non-competition and non-solicitation provisions in
favour of the Company. In April 2013, Mr. Rampertab received a grant of 25,000 options of which 12,500 vested immediately on issuance
and the remaining 12,500 options vested on November 30, 2013. In March 2014, Mr. Rampertab received a grant of 25,000 options of
which 12,500 vested immediately on issuance and the remaining 12,500 options vested on November 30, 2014.
The employment agreement with Domenic Della Penna, the Chief Financial Officer of the Company, effective November 24,
2014 entitles Mr. Della Penna to receive a base salary of C$275,000, which is paid in Canadian dollars, per year. In addition, he is entitled
to: (a) participate in the Option Plan; (b) participate in all employee benefit plans and programs; and (c) a car allowance of C$1,500 per
month. The agreement provides for automatic renewal from year to year in absence of notice of termination from the Company at least 60
days prior to the anniversary date. If the agreement is terminated without cause, it requires payment to Mr. Della Penna based upon a
formula that commences with the equivalent of approximately three months’ base salary and increases by approximately six weeks of base
salary for every full year of service. If such termination without cause occurs within six months of a change of control of the Company that
occurs after November 24, 2015, it requires payment to Mr. Della Penna based on a formula that commences with the equivalent of
approximately thirteen months’ base salary and increases by approximately six weeks for every full year of service. Mr. Della Penna’s
employment agreement contains intellectual property, non-competition and non-solicitation provisions in favour of the Company. Mr. Della
Penna was granted 60,000 options, of which 15,000 vested immediately on issuance and the remaining options vest as to 15,000 each year
on November 30, 2015, 2016 and 2017.
-52-
The employment agreement with John Allport, the Vice President Legal Affairs and Licensing, effective September 1, 2004
entitles Mr. Allport to receive a base salary of C$95,000, which is paid in Canadian dollars, per year. In addition, he is entitled to: (a)
participate in the Option Plan; (b) participate in all employee benefit plans and programs; and (c) a car allowance of C$1,000 per month.
The employment agreement is for an indefinite term subject to termination on six months’ notice. In December 2011, Mr. Allport’s base
salary was increased to C$145,000. In February 2012, Mr. Allport received a grant of 250,000 options of which 175,000 vested
immediately on issuance and the remaining 75,000 options vested on February 17, 2013. Mr. Allport’s employment agreement includes
intellectual property, non-competition and non-solicitation provisions in favour of the Company. In April 2013, Mr. Allport received a
grant of 25,000 options of which 12,500 vested immediately on issuance and the remaining 12,500 options vested on November 30, 2013.
In March 2014, Mr. Allport received a grant of 50,000 options of which 25,000 vested immediately on issuance and the remaining 25,000
options vested on November 30, 2014.
Incentive Plan Awards
Outstanding Option-Based Awards and Share-Based Awards – The following table sets forth for each Named Executive Officer
all awards outstanding at the end of the most recently completed financial year, including awards granted before the most recently
completed financial year. Each option grant allows the holder to purchase one common share of the Company’s common shares.
Option-based Awards
Share-based Awards
Number of
securities
underlying
unexercised
options
(#)
(b)
2,763,940
300,000
75,000
50,000
300,000
75,000
50,000
60,000
40,000
25,000
25,000
250,000
25,000
50,000
60,000
Option
exercise
price
(U.S.$)
Option
expiration
date
Value of
unexercised
in-the-money
options
(U.S.$)
Number of shares
or
units of
shares that
have not vested
(#)
(c)
3.62
C$3.27
C$1.81
C$4.29
C$3.27
C$1.81
C$4.29
C$2.62
C$3.27
C$1.81
C$4.29
C$3.27
C$1.81
C$4.29
C$3.22
(d)
Sept. 10, 2014
(e) (2)
$884,461
Feb. 16, 2022
Apr. 13, 2020
Feb. 28, 2019
Feb. 16, 2022
Apr. 13, 2020
Feb. 28, 2019
Nov. 29, 2020
Feb. 16, 2017
Apr. 13, 2020
Feb. 28, 2019
Feb. 16, 2022
Apr. 13, 2020
Feb. 28, 2019
Nov. 30, 2024
C$6,000
C$220,500
N/A
C$6,000
C$220,500
N/A
C$39,600
C$4,000
C$36,750
N/A
C$2,500
C$36,750
N/A
C$3,600
(f)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Market or payout
value
of share-
based awards that
have not
vested
(U.S.$)
(g)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Name
(a)
Drs. Isa Odidi and
Amina Odidi(1)
Dr. Isa Odidi
Dr. Amina Odidi
Shameze
Rampertab(3)
John Allport
Domenic Della
Penna(4)
Notes
(1) These option-based awards are held jointly.
(2) The value of unexercised options at year-end is calculated by subtracting the option exercise price from the closing price of the
common shares of the Company on the TSX for C$ exercise prices and Nasdaq for US$ exercise prices on November 30, 2014 (C$3.28
and $2.90, respectively) and multiplying the result by the number of common shares underlying an option.
(3) Mr. Rampertab served as the Company’s Vice President and Chief Financial Officer from November 2010 until his resignation
effective on October 10, 2014.
(4) Mr. Della Penna was appointed as Chief Financial Officer of the Company effective November 24, 2014.
Incentive Plan Awards – Value Vested or Earning During the Year – The following table sets forth details of the value vested or
earned during the most recently completed financial year for each incentive plan award.
-53-
Name
(a)
Drs. Isa Odidi
Dr. Amina Odidi
Shameze Rampertab(2)
John Allport
Domenic Della Penna(3)
Notes
Option-based awards -
Value vested during
the year
(U.S.$)
Share-based awards -
Value vested during
the year
(U.S.$)
(b)(1)
C$4,750
C$4,750
C$11,708
C$4,750
C$900
(c)
N/A
N/A
N/A
N/A
N/A
Non-equity incentive
plan compensation -
Value earned during
the year
(U.S.$)
(d)
Nil
Nil
Nil
Nil
Nil
(1) The amount represents the theoretical total value if the options had been exercised on the vesting date, established by calculating the
difference between the closing price of the common shares of the Company on the TSX on the vesting date and the exercise price.
(2) Mr. Rampertab served as the Company’s Vice President and Chief Financial Officer from November 2010 until his resignation
effective on October 10, 2014.
(3) Mr. Della Penna was appointed as Chief Financial Officer of the Company effective November 24, 2014.
Pension Plan Benefits
The Company does not provide a defined benefit pension plan or a defined contribution pension plan for any of its Named
Executive Officers, nor does it have a deferred compensation pension plan for any of its Named Executive Officers. There are no amounts
set aside or accrued by the Company or its subsidiaries to provide pension, retirement or similar benefits.
Termination and Change of Control Benefits
The employment agreement with each of the Named Executive Officers, Dr. Isa Odidi and Dr. Amina Odidi, by virtue of it being
a fixed-term agreement with automatic renewal provisions, effectively provides for payments to the applicable Named Executive Officer
following termination of the employment agreement unless the agreement has been terminated in accordance with its terms. As a result, if
either Named Executive Officer had been terminated on the last business day of the Company’s most recently completed financial year, it
is estimated that an amount of up to approximately C$1.3 million would be payable to such Named Executive Officer, which is the amount
that would have been payable through to September 30, 2016, at each Named Executive Officer’s current annual salary level. Given their
nature as fixed term employment agreements, if notice is properly provided to not renew the agreement following the term ending
September 30, 2016, then as such date approaches the amount payable upon termination to the Named Executive Officer will decrease to
the point where no amount would be payable upon termination as at September 30, 2016. Any termination of the employment of a Named
Executive Officer must be undertaken by and is subject to the prior approval of the Board. There are no payments applicable under the
employment agreements of the Named Executive Officers relating to a change of control of the Company.
For a discussion of certain termination and change of control benefits under the employment agreement with the Named Executive
Officer, Mr. Della Penna, see “Employment Agreements” above.
Director Compensation
The following table sets forth all amounts of compensation provided to the non-executive directors for the Company’s most
recently completed financial year.
Name
(a)
Eldon Smith
Kenneth Keirstead
Bahadur Madhani
Fees earned
(b)
C$23,569
C$56,969
C$62,563
Share-based
awards
(c) (1)
C$22,650
N/A
N/A
Option-based
awards
(d) (2)
C$138,687
C$138,687
C$138,687
Non-equity
incentive plan
compensation Pension value
(e)
N/A
N/A
N/A
(f)
N/A
N/A
N/A
All other
compensation
(g)
N/A
N/A
N/A
Total
(h)
C$184,906
C$195,656
C$201,250
-54-
Notes:
(1) DSUs that were earned. Does not include DSUs earned in the previous financial year and granted in the most recently completed
financial year.
(2) Option-based awards for fiscal year 2014 were issued on March 13, 2014 and November 30, 2014.
Significant factors necessary to understand the information disclosed in the Director Compensation Table above include the
following: Non-management directors receive an annual retainer of $25,000 paid in Canadian dollars. The Audit Committee chair receives
an annual retainer of $10,000 paid in Canadian dollars. The Corporate Governance Committee chair and Compensation Committee Chair,
each receives an annual retainer of $5,000 paid in Canadian dollars. Non-chair committee members, are paid an additional $2,500 per year
per committee paid in Canadian dollars. Meetings will result in an additional $1,000 per day per meeting paid in Canadian dollars.
Outstanding Option-Based Awards and Share-Based Awards – The following table sets forth all amounts of option-based and share-based
awards to the non-executive directors for the Company’s most recently completed financial year.
Name
Number of
securities
underlying
unexercised
options
(#)
Option-based Awards
Option
expiration
date
Option
exercise
price
(U.S.$)
Value of
unexercised
in-the-money
options
(U.S.$)
Number of shares
or
units of
shares that
have not vested
(#)
Share-based Awards
(a)
Eldon Smith
Kenneth Keirstead
Bahadur Madhani
Notes:
(b)
5,000
25,000
10,000
25,000
37,500
37,500
5,000
25,000
10,000
25,000
37,500
37,500
5,000
25,000
10,000
25,000
37,500
37,500
(c)
C$2.88
C$3.25
C$2.88
C$1.81
C$3.22
C$4.29
C$2.88
C$3.25
C$2.88
C$1.81
C$3.22
C$4.29
C$2.88
C$3.25
C$2.88
C$1.81
C$3.22
C$4.29
(d)
Nov. 30, 2016
Nov. 30, 2016
Oct. 22, 2019
Apr. 13, 2020
Nov. 30, 2019
Feb. 28, 2019
Nov. 30, 2016
Nov. 30, 2016
Oct. 22, 2019
Apr. 13, 2020
Nov. 30, 2019
Feb. 28, 2019
Nov. 30, 2016
Nov. 30, 2016
Oct. 22, 2019
Apr. 13, 2020
Nov. 30, 2019
Feb. 28, 2019
(e) (1)
C$2,000
C$750
C$4,000
C$36,750
C$2,250
Nil
C$2,000
C$750
C$4,000
C$36,750
C$2,250
Nil
C$2,000
C$750
C$4,000
C$36,750
C$2,250
Nil
(f) (2)
49,909
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Market or payout
value
of share-
based awards that
have not
vested
(U.S.$)
(g) (3)
C$160,750
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
(1) The value of unexercised options at year-end is calculated by subtracting the option exercise price from the closing price of the
common shares of the Company on the TSX on November 30, 2014 (C$3.28) and multiplying the result by the number of common
shares underlying an option.
(2) These DSUs are permitted to be redeemed only following termination of Board service. Includes DSUs earned as at November 30,
2014.
(3) The value of DSUs at year-end is calculated from the closing price of the common shares of the Company on the TSX on November
30, 2014 (C$3.28) and multiplying by the number of common shares underlying a DSU.
-55-
Incentive Plan Awards – Value Vested or Earned During The Year – The following table sets forth all amounts of option-based and
share-based awards vested to the non-executive directors of the Company for the most recently completed financial year and no non-equity
incentive plan compensation was earned during the most recently completed financial year.
Name
Option-based awards -
Value vested during
the year
(U.S.$)
Share-based awards -
Value vested during
the year
(U.S.$)
(a)
Eldon Smith
Kenneth Keirstead
Bahadur Madhani
Notes:
(b) (1)
C$4,688
C$4,688
C$4,688
(c) (2)
Nil
N/A
N/A
Non-equity incentive plan
compensation -
Value earned during
the year
(U.S.$)
(d)
Nil
Nil
Nil
(1) The amount represents the theoretical total value if the options had been exercised on the vesting date, established by calculating the
difference between the closing price of the common shares of the Company on the TSX on the vesting date and the exercise price.
(2) The amount represents the theoretical total value of DSUs which were fully vested on their respective dates of issuance. DSUs are
issued at the calculated market value of a common share on the date of issuance.
Directors’ and Officers’ Liability Insurance
The Company maintains insurance for the liability of its directors and officers arising out of the performance of their duties. The
total amount of such insurance maintained is $8,000,000 subject to a deductible loss payable of $50,000 to $100,000 by the Company. The
premium payable by the Company for the period from October 25, 2014 to October 25, 2015 is $91,375.
C.
Board Practices
Board of Directors
See Items 6.A and 6.B.
Committees of the Board of Directors
AUDIT COMMITTEE
The Audit Committee of the Board monitors our financial activities, policies, and internal control procedures. The Audit
Committee assists the Board in fulfilling its oversight responsibility to shareholders, potential shareholders, the investment community, and
others with respect to the Company’s financial statements, financial reporting process, systems of internal accounting and disclosure
controls, performance of the external auditors, and risk assessment and management. The Audit Committee has the power to conduct or
authorize investigations into any matters within its scope of responsibilities, with full access to all books, records, facilities and personnel
of the Company, its auditors and its legal advisors. In connection with such investigations or otherwise in the course of fulfilling its
responsibilities under the Audit Committee Charter, the Audit Committee has the authority to independently retain special legal,
accounting, or other consultants to advise it.
Audit Committee Charter
The charter of the Audit Committee can be found on the Company’s website at www.intellipharmaceutics.com.
Composition of the Audit Committee
Our Audit Committee is comprised of Kenneth Keirstead, Bahadur Madhani and Dr. Eldon Smith, each of whom is considered
independent and financially literate (as such terms are defined under applicable Canadian
-56-
securities legislation) and satisfies the independence criteria of Rule 10A3-(b)(1) under the U.S. Exchange Act. The members of the Audit
Committee have selected a Chair from amongst themselves, being Mr. Madhani.
Under the Securities and Exchange Commission rules implementing the Sarbanes-Oxley Act of 2002, Canadian issuers filing
reports in the United States must disclose whether their audit committees have at least one “audit committee financial expert”.
Additionally, under NASDAQ Listing Rule 5605(c)(2)(A), NASDAQ requires that one member of the audit committee be financially
sophisticated, meaning that they must have “past employment experience in finance or accounting, requisite professional certification in
accounting, or any other comparable experience or background which results in the individual’s financial sophistication, including being or
having been a chief executive officer, chief financial officer or other senior officer with financial oversight responsibilities.” The Board has
determined that Mr. Madhani qualifies as an audit committee financial expert under the applicable Securities and Exchange Commission
rules and as financially sophisticated under the applicable NASDAQ rules.
Relevant Education and Experience
Kenneth Keirstead is educated in clinical biochemistry as a graduate of the Pathology Institute in Halifax; and business
administration, as a graduate of the College of William and Mary and Columbia University. Mr. Keirstead has been a director of the
Company since January 2006. He has worked in the healthcare delivery and pharmaceutical industries for over 45 years. He was President
and CEO, Sanofi Winthrop Canada Inc.; General Manager, Squibb Medical Systems International; President, Chemfet International and
President, Quinton Instruments among other positions. Mr. Keirstead has published studies and reports on healthcare and related services
topics. Since 1998 Mr. Keirstead’s principal occupation has been as Executive Manager of the Lyceum Group, a Canadian consulting
services company primarily active in the healthcare field, of which Mr. Keirstead is the founder.
Bahadur Madhani is a chartered accountant who has been a director of the Company since March 31, 2006. He was a member of
the advisory board of Quebecor Ontario and former Chairman of United Way of Toronto, former Chair of YMCA of Greater Toronto,
former Chair of Nelson Mandela Children’s Fund Canada, current Chair of YMCA Canada and former Chair, Toronto Grants Review
Team of the Ontario Trillium Foundation. He was awarded membership in the Order of Canada in 2001. Since 1983, Mr. Madhani’s
principal occupation has been as President and CEO of Equiprop Management Limited, a Canadian property management company of
which Mr. Madhani is the principal shareholder. He is currently the Chair of YMCA Canada.
Dr. Eldon Smith is a medical doctor who graduated from the Dalhousie University Medical School and who has been a director of
the Company since October 2009. He is president and CEO of Eldon R. Smith and Associates Ltd. a private healthcare consulting
company. He is also professor emeritus at the University of Calgary, where he served as the Dean of the Faculty of Medicine subsequent to
being Head of the Department of Medicine and the Division of Cardiology. Dr. Smith is past-President of the Canadian Cardiovascular
Society and served as Chairman of the Scientific Review Committee of the Heart and Stroke Foundation of Canada. Dr. Smith was
appointed as an Officer of the Order of Canada. In October 2006, Dr. Smith was appointed by the Honourable Tony Clement, Minister of
Health, to chair the Steering Committee responsible for developing a new Heart-Health strategy to fight heart disease in Canada. Dr. Smith
currently serves as a director of Canadian Natural Resources Limited, Aston Hill Financial Inc., Resverlogix Corp, and Zenith Epigenetics
Corp.
Pre-Approval Policies and Procedures
The Audit Committee reviewed with the independent auditor (who is responsible for expressing an opinion on the conformity of
the Company’s audited financial statements with United States generally accepted accounting principles) their judgments as to the quality,
not just the acceptability, of the Company’s accounting principles and such other matters as are required to be discussed with the Audit
Committee under Canadian and United States generally accepted auditing standards. In addition, the Audit Committee has discussed with
the independent auditor the auditor’s independence from management and the Company including the matters in the written disclosures
provided to the Audit Committee by the independent auditor, and considered the compatibility of non-audit services with the auditor’s
independence.
The Company’s independent auditor is accountable to the Board and to the Audit Committee. The Board, through the Audit
Committee, has the ultimate responsibility to evaluate the performance of the independent auditor,
-57-
and through the shareholders, to appoint, replace and compensate the independent auditor. Under the Sarbanes-Oxley Act of 2002, the
independent auditor of a public company is prohibited from performing certain non-audit services. The Audit Committee has adopted
procedures and policies for the pre-approval of non-audit services, as described in the Audit Committee Charter. Under the terms of such
policies and procedures, the Audit Committee has adopted a list of pre-approved services, including audit and audit-related services and tax
services, and a list of prohibited non-audit services deemed inconsistent with an auditor’s independence.
The list of pre-approved services includes:
1.
Audit Services
· Audits of the Company’s consolidated financial statements;
· Statutory audits of the financial statements of the Company’s subsidiaries;
· Reviews of the quarterly consolidated financial statements of the Company;
· Services associated with registration statements, prospectuses, periodic reports and other documents filed with securities
regulatory bodies (such as the SEC and Ontario Securities Commission) or other documents issued in connection with
securities offerings (e.g., comfort letters and consent letters) and assistance in responding to comment letters from securities
regulatory bodies;
· Special attest services as required by regulatory and statutory requirements;
· Regulatory attestation of management reports on internal controls as required by the regulators; and
· Consultations with the Company’s management as to the accounting or disclosure treatment of transactions or events and/or
the actual or potential impact of final or proposed rules, standards or interpretations by the securities regulatory authorities,
accounting standard setting bodies (such as the Financial Accounting Standards Board or Chartered Professional Accountants
of Canada), or other regulatory or standard setting bodies.
2.
Audit-Related Services
· Presentations or training on accounting or regulatory pronouncements;
· Due diligence services related to accounting and tax matters in connection with potential acquisitions / dispositions; and
· Advice and documentation assistance with respect to internal controls over financial reporting and disclosure controls and
procedures of the Company.
3.
Tax Services
a. Compliance Services
· Assistance with the preparation of corporate income tax returns and related schedules for the Company and its subsidiaries;
· Assistance with the preparation of Scientific Research & Experimental Development investment tax credit claims and
amended tax returns of the Company; and
· Assistance in responding to Canada Revenue Agency or Internal Revenue Service on proposed reassessments and other
matters.
b. Canadian & International Planning Services
· Advice with respect to cross-border/transfer pricing tax issues;
· Advice related to the ownership of corporate intellectual property in jurisdictions outside of Canada;
-58-
· Assistance in interpreting and understanding existing and proposed domestic and international legislation, and the
administrative policies followed by various jurisdictions in administering the law, including assisting in applying for and
requesting advance tax rulings or technical interpretations;
· Assistance in interpreting and understanding the potential impact of domestic and foreign judicial tax decisions;
· Assistance and advising on routine planning matters; and
· Assistance in advising on the implications of the routine financing of domestic and foreign operations, including the tax
implications of using debt or equity in structuring such financing, the potential impact of non-resident withholding tax and the
taxation of the repatriation of funds as a return of capital, a payment of a dividend, or a payment of interest.
c. Commodity Tax Services
· Assistance regarding Harmonized Sales Tax/Goods and Services Sales Tax/Provincial Sales Tax/Customs/Property Tax
filings and assessments;
· Commodity tax advice and compliance assistance with business reorganizations;
· Advice and assistance with respect to government audits/assessments;
· Advice with respect to other provincial tax filings and assessments; and
· Assistance with interpretations or rulings.
The list of prohibited services includes:
· Bookkeeping or other services related to the preparation of accounting records or financial statements;
· Financial information systems design and implementation;
· Appraisal or valuation services for financial reporting purposes;
· Actuarial services for items recorded in the financial statements;
· Internal audit outsourcing services;
· Management functions;
· Human resources;
· Certain corporate finance and other services;
· Legal services; and
· Certain expert services unrelated to the audit.
The Audit Committee also discusses with the Company’s independent auditor the overall scope and plans for their audit. The
Audit Committee meets with the independent auditor, with and without management present, to discuss the results of their examination,
their evaluations of the Company’s internal controls, and the overall quality of the Company’s financial reporting. The Audit Committee
held four meetings during the period from December 1, 2013 to November 30, 2014.
In reliance on the reviews and discussions referred to above, the Audit Committee recommended to the Board (and the Board
approved) that the audited consolidated financial statements be included in the Annual Report for the year ended November 30, 2014 for
filing with the Canadian provincial securities commissions and the SEC.
-59-
COMPENSATION, NOMINATING, AND CORPORATE GOVERNANCE COMMITTEE
Compensation Committee Mandate and Purpose
The Compensation Committee of the Board is a standing committee of the Board whose primary function is to assist the Board in
fulfilling its responsibilities relating to:
· the development, review and periodic approval of the Company's compensation philosophy that attracts and retains key
executives and employees, while supporting the overall business strategy and objectives and links compensation with business
objectives and organizational performance;
· evaluate and approve all compensation of executive officers including salaries, bonuses and equity compensation that are
required to be determined;
· review the Company's Option Plan, the employee RSU plan and the DSU plan on an annual basis;
· review and make recommendations to the Board on compensation payable to senior officers of the Company to be hired
subsequent to the adoption of the Charter; and
· produce a report annually on executive officer compensation for inclusion in the proxy circular of the Company.
Compensation Committee Charter
The charter of the Compensation Committee can be found on the Company’s website at www.intellipharmaceutics.com.
Composition of the Compensation Committee
The Compensation Committee is composed of Kenneth Keirstead, Bahadur Madhani and Dr. Eldon Smith, each of whom is
considered independent and is a director of the Company. All of the members shall be "independent" as such term is defined in applicable
securities legislation. In no case shall a member be a current employee or immediate family member of a current employee. The members
of the Compensation Committee have selected a Chair from amongst themselves, being Dr. Eldon Smith.
Corporate Governance Committee Mandate and Purpose
The Corporate Governance Committee of the Board is a standing committee of the Board whose primary function is to assist the
Board in dealing with the corporate governance matters described in the Charter.
Corporate Governance Committee Charter
The charter of the Corporate Governance Committee can be found the Company’s website at www.intellipharmaceutics.com.
Composition of the Corporate Governance Committee
The Corporate Governance Committee is composed of three directors, two of whom shall be “independent” as such term is
defined in applicable securities legislation. Kenneth Keirstead and Dr. Eldon Smith is each considered independent and is a director of the
Company. John Allport, an officer of the Company, is not considered independent and is a director of the Company. The members of the
Corporate Governance Committee have selected a Chair from amongst themselves, being Kenneth Keirstead.
D.
Employees
The number of full-time employees as of each of last three fiscal years is as follows:
-60-
Research Employees
Administrative Employees
November 30, 2014
35
11
November 30, 2013
30
8
November 30, 2012
29
8
Our employees are not governed by a collective agreement. We have not experienced a work stoppage and believe our employee
relations are satisfactory. For each of the last three fiscal years, all employees of the Company were employed at the Company’s offices in
Toronto. In February 2012, the Company appointed its first U.S. employee in its U.S. subsidiary, IPC Ltd. and this employee resigned in
December 2012.
E.
Share Ownership
The following table states the names of the directors and officers of the Company, the positions within the Company now held by
them, and the approximate number of common shares of the Company beneficially owned or over which control or direction is exercised
by each of them as of February 23, 2015.
Name
Dr. Isa
Odidi
Dr. Amina
Odidi
John N.
Allport
Dr. Eldon
R. Smith
Position
with the
Company
Number of
Common
Shares
Owned
Percentage
of Common
Shares
Owned
Number of
Stock
Options
Held(2)
Exercise
Price
Option
Expiry
dd/mm/yyyy
Number of
Currently
Exercisable
Options(4)
Number of
Common
Shares
Issuable on
Conversion
of
Convertible
Debt
Number of
Deferred
Share Units
Held
Number of
Restricted
Share
Units Held
Chief
Executive
Officer and
Chairman of
the Board
and Director
of the
Company
President,
Chief
Operating
Officer and
Director of
the
Company
Vice-
President,
Legal
Affairs and
Licensing
and Director
of the
Company
Director of
the
Company
5,997,751(1)
25.5%
2,763,940
300,000
75,000
50,000
$3.62
C$3.27
C$1.81
C$4.29
10/09/2016
16/02/2022
13/04/2020
28/02/2019
1,658,364
300,000
75,000
50,000
500,000(3)
N/A
N/A
5,997,751(1)
25.5% 2,763,940
300,000
75,000
50,000
$3.62
C$3.27
C$1.81
C$4.29
10/09/2016
16/02/2022
13/04/2020
28/02/2019
1,658,364
300,000
75,000
50,000
500,000(3)
N/A
N/A
110,558
0.48% 250,000
25,000
50,000
C$3.27
C$1.81
C$4.29
16/02/2022
13/04/2020
28/02/2019
250,000
25,000
50,000
N/A
N/A
Nil
21,731
0.10%
10,000
5,000
25,000
25,000
37,500
37,500
C$2.88
C$2.88
C$3.25
C$1.81
C$4.29
C$3.22
22/10/2019
30/11/2016
30/11/2016
13/04/2020
28/02/2019
30/11/2019
10,000
5,000
25,000
25,000
18,750
18.750
N/A
50,347
N/A
-61-
Kenneth
Keirstead
Director of the
Company
Nil
Nil
Bahadur
Madhani
Director of the
Company
5,507
0.02%
27,600
0.12%
10,000
5,000
25,000
25,000
37,500
37,500
10,000
5,000
25,000
25,000
37,500
37,500
50,000
15,000
C$2.88
C$2.88
C$3.25
C$1.81
C$4.29
C$3.22
C$2.88
C$2.88
C$3.25
C$1.81
C$4.29
C$3.22
C$3.82
C$1.81
22/10/2019
30/11/2016
30/11/2016
13/04/2020
28/02/2019
30/11/2019
22/10/2019
30/11/2016
30/11/2016
13/04/2020
28/02/2019
30/11/2019
24/05/2021
13/04/2020
10,000
5,000
25,000
25,000
18,750
18.750
10,000
5,000
25,000
25,000
18,750
18.750
50,000
15,000
N/A
Nil
N/A
N/A
Nil
N/A
N/A
N/A
Nil
Vice-President
Pharmaceutical
Analysis and
Chemistry of
the Company
Chief
Financial
Officer of the
Company
Dr. Patrick
Yat
Domenic
Della Penna
Totals
Notes:
Nil
Nil
60,000
C$3.22 30/11/2024
15,000
N/A
N/A
Nil
6,163,147
26.27% 4,483,940
3,220,864
500,000
50,347
Nil
(1) 2,763,940 performance-based options held by Odidi Holdings Inc., a private company owned and controlled by Dr. Isa Odidi, Dr.
Amina Odidi and their family trust, 300,000 stock options held by each of Dr. Isa Odidi and Dr. Amina Odidi.
(2) For information regarding option expiration dates and exercise price refer to the tables included under Item 6.B.
(3) On January 10, 2013, the Company completed a private placement financing of the Debenture in the aggregate principal amount of $1.5
million, which was originally due to mature January 1, 2015. The Debenture bears interest at a rate of 12% per annum, payable monthly,
is pre-payable at any time at the option of the Company, and is convertible at any time into 500,000 common shares at a conversion
price of US$3.00 per common share at the option of the holder. Drs. Isa and Amina Odidi, principal stockholders, directors and
executive officers of the Company provided the Company with the $1.5 million of the proceeds for the Debenture. Effective October 1,
2014, the original maturity date for the Debenture was extended to July 1, 2015.
(4)
Includes options exercisable within 60 days of the date of this filing.
As of February 23, 2015, the directors and executive officers of the Company as a group owned, directly or indirectly, or exercised
control or direction over 6,163,147 common shares, representing approximately 26.2% of the issued common shares of the Company (and
beneficially owned approximately 9,884,011 common shares representing 36.4% of our common shares including common shares issuable
upon the exercise of outstanding options and the conversion of the convertible debenture that are exercisable or convertible within 60 days
of the date hereof).
The Company has in place a stock option plan (the “Option Plan”) for the benefit of certain officers, directors, employees and
consultants of the Company, including the Named Executive Officers (see below under “Employee Stock Option Plan”). Certain Named
Executive Officers have been issued options under such plan. The Company has also granted performance-based options to Dr. Isa Odidi
and Dr. Amina Odidi pursuant to a separate option agreement, which was negotiated with the Named Executive Officers at the same time
as their employment agreements. These options vest upon the Company attaining certain milestones relating to FDA filings and approvals
for company drugs, such that 276,394 options vest in connection with each of the FDA filings for the first five Company drugs and 276,394
options vest in connection with each of the FDA approvals for the first five Company drugs. To date, the level of these performance-based
options has been taken into account by the Board and impacted the Company’s decisions about base salary and option-based awards under
the Option Plan for the Named Executive Officers. No other performance-based options have been granted to any other Named Executive
Officer.
-62-
Employee Stock Option Plan
The Option Plan was adopted effective October 22, 2009 as part of the IPC Arrangement Transaction approved by the
shareholders of IPC Ltd., our predecessor company, at the meeting of shareholders on October 19, 2009. Subject to the requirements of the
Option Plan, the Board, with the assistance of the Compensation Committee, has the authority to select those directors, officers, employees
and consultants to whom options will be granted, the number of options to be granted to each person and the price at which common shares
of the Company may be purchased. Grants are determined based on individual and aggregate performance determined by the Board.
The key features of the Option Plan are as follows:
·
·
·
·
The eligible participants are full-time and part-time employees, officers and directors of, or consultants to, the Company or its
affiliates, which may be designated from time to time by the Board.
The fixed maximum percentage of common shares issuable under the Option Plan is 10% of the issued and outstanding common
shares from time to time. The Option Plan will automatically “reload” after the exercise of a an option provided that the number of
common shares issuable under the Option Plan does not then exceed the maximum percentage of 10%.
There are no restrictions on the maximum number of options which may be granted to insiders of the Company other than not more
than 1% of the total common shares outstanding on a non-diluted basis can be issued to non-executive directors of the Company
pursuant to options granted under the Option Plan and the value of any options granted to any non-executive director of the
Company, shall not, on an annual basis, exceed $100,000.
The Board determine the exercise price of each option at the time the option is granted, provided that such price is not lower than
the “market price” of common shares at the time the option is granted. “Market price” means the volume weighted average trading
price of common shares on the TSX, or another stock exchange where the majority of the trading volume and value of common
shares occurs, for the five trading days immediately preceding the relevant date, calculated in accordance with the rules of such
stock exchange.
· Unless otherwise determined by the Board, each option becomes exercisable as to 33⅓% on a cumulative basis, at the end of each
of the first, second and third years following the date of grant.
·
·
The period of time during which a particular option may be exercised is determined by the Board, subject to any Employment
Contract or Consulting Contract (both as hereinafter defined), provided that no such option term shall exceed 10 years.
If an option expiration date falls within a “black-out period” (a period during which certain persons cannot trade common shares
pursuant to a policy of the Company’s respecting restrictions on trading), or immediately following a black-out period, the
expiration date is automatically extended to the date which is the tenth business day after the end of the black-out period.
· Options may terminate prior to expiry of the option term in the following circumstances:
·
·
on death of an optionee, options vested as at the date of death are immediately exercisable until the earlier of 180 days
from such date and expiry of the option term; and
if an optionee ceases to be a director, officer, employee or consultant of the Company for any reason other than death,
including receipt of notice from the Company of the termination of his, her or its Employment Contract or Consulting
Contract (as defined below), options vested as at the date of termination are exercisable until the earlier of 120 days
following such date and expiry of the option term,
-63-
subject however to any contract between the Company and any employee relating to, or entered into in connection with, the
employment of the employee or between the Company and any director with respect to his or her directorship or resignation there
from (an “Employment Contract”), any contract between the Company and any consultant relating to, or entered into in
connection with, services to be provided to the Company (a “Consulting Contract”) or any other agreement to which the Company
is a party with respect to the rights of such person upon termination or change in control of the Company.
· Options and rights related thereto held by an optionee are not to be assignable or transferable except on the death of the optionee.
·
·
·
If there is a take-over bid (within the meaning of the Securities Act (Ontario)) made for all or any of the issued and outstanding
common shares of the Company, then all options outstanding become immediately exercisable in order to permit common shares
issuable under such options to be tendered to such bid.
If there is a consolidation, merger, amalgamation or statutory arrangement involving the Company, separation of the business of the
Company into two or more entities or sale of all or substantially all of the assets of the Company to another entity, the optionees
will receive, on exercise of their options, the consideration they would have received had they exercised their options immediately
prior to such event. In such event and in the event of a securities exchange take-over bid, the Board may, in certain circumstances,
require optionees to surrender their options if replacement options are provided. In the context of a cash take-over bid for 100% of
the issued and outstanding common shares of the Company, optionees may elect to conditionally surrender their options or, if
provided for in an agreement with the offeror, automatically exchange their options for options of the offeror.
The Board may from time to time in its absolute discretion amend, modify and change the provisions of the Option Plan or any
options granted pursuant to the Option Plan, provided that any amendment, modification or change to the provisions of the Option
Plan or any options granted pursuant to the Option Plan shall:
·
·
·
not adversely alter or impair any option previously granted;
be subject to any regulatory approvals, where required, including, where applicable, the approval of the TSX and/or such
other exchange as may be required; and
not be subject to shareholder approval in any circumstances, except where the amendment, modification or change to the
Option Plan or option would:
(i)
reduce the exercise price of an option held by an insider of the Company;
(ii) extend the term of an option held by an insider beyond the original expiration date (subject to such date being
extended in a black-out extension situation);
(iii) increase the fixed maximum percentage of common shares issuable under the Option Plan; or
(iv) amend the amendment provision of the Option Plan;
in which case the amendment, modification or change will be subject to shareholder approval in accordance with the rules
of the TSX and/or such other exchange as may be required. Amendments to the Option Plan not requiring shareholder
approval may for example include, without limitation:
·
amendments of a “housekeeping nature”, including any amendment to the Option Plan or an option that is necessary to
comply with applicable law or the requirements of any regulatory authority or stock exchange;
-64-
·
·
·
·
·
·
·
·
·
changes to the exercise price of an option to an exercise price not below the “market price” unless the change is a reduction
in the exercise price of an option held by an insider of the Company;
amendments altering, extending or accelerating any vesting terms or conditions in the Option Plan or any options;
changes amending or modifying any mechanics for exercising an option;
amendments changing the expiration date (including acceleration thereof) or changing any termination provision in any
option, provided that such change does not entail an extension beyond the original expiration date of such option (subject
to such date being extended in a black-out extension situation);
amendments introducing a cashless exercise feature, payable in securities, whether or not such feature provides for a full
deduction of the number of underlying securities from the Option Plan maximum;
amendments changing the application of the provisions of the Option Plan dealing with adjustments in the number of
shares, consolidations and mergers and take-over bids;
amendments adding a form of financial assistance or amending a financial assistance provision which is adopted;
amendments changing the eligible participants of the Option Plan; and
amendments adding a deferred or restricted share unit provision or any other provision which results in participants
receiving securities while no cash consideration is received by the Company.
The Board may discontinue the Option Plan at any time without consent of the participants under the Option Plan provided that
such discontinuance shall not adversely alter or impair any option previously granted.
A copy of the Option Plan is available upon request in writing to the Chief Financial Officer of the Company at 30 Worcester
Road, Toronto, Ontario, M9W 5X2 or on www.sedar.com.
The 2,354,161 shares that are currently authorized for issuance under the Option Plan represent 10% of the common shares issued
and outstanding as at February 23, 2015. Of the options authorized for issuance under the Option Plan, a total of 1,970,100 have been
issued, representing 8.3% of the shares issued and outstanding as of February 23, 2015. As of February 23, 2015, 85,000 options have been
exercised under the Plan.
Restricted Share Unit Plan
The Company established a restricted share unit plan (the “RSU Plan”) to form part of its incentive compensation arrangements
available for officers and employees of the Company and its designated affiliates as of May 28, 2010, when the RSU Plan received
shareholder approval.
The key features of the RSU Plan are as follows:
·
·
The stated purpose of the RSU Plan is to advance the interests of the Company through the motivation, attraction and retention of
employees and officers of the Company and the designated affiliates of the Company and to secure for the Company and the
shareholders of the Company the benefits inherent in the ownership of common shares by employees and officers of the Company,
it being generally recognized that share incentive plans aid in attracting, retaining and encouraging employees and officers due to
the opportunity offered to them to acquire a proprietary interest in the Company.
Employees and officers, including both full-time and part-time employees, of the Company and any designated affiliate of the
Company, but not any directors of the Company, are eligible to participate under the RSU Plan. By the terms of the RSU Plan, Dr.
Isa Odidi and Dr. Amina Odidi are specifically not eligible to participate.
-65-
·
·
The RSU Plan is administered by the Board or a committee thereof, which will determine, from time to time, who may participate in
the RSU Plan, the number of RSUs to be awarded and the terms of each RSU, all such determinations to be made in accordance with
the terms and conditions of the RSU Plan.
The number of common shares available for issuance upon the vesting of RSUs awarded under the RSU Plan is limited to 330,000
common shares of the Company.
· A separate notional account will be maintained for each participant under the RSU Plan. Each such account will be credited with
RSUs awarded to the participant from time to time by way of a bookkeeping entry in the books of the Company. On the vesting of
the RSUs and the corresponding issuance of common shares to the participant, or on the forfeiture and cancellation of the RSUs, the
RSUs credited to the participant’s account will be cancelled.
· At the time of the award of RSUs, the Board will determine in its sole discretion the vesting criteria (whether based on time or
performance measures) applicable to the awarded RSUs. Unless otherwise determined by the Board at the time of the award, RSUs
will vest in respect of 33 1/3 % of the common shares subject to the RSUs on the first day after each of the first three anniversaries
of the award date of such RSU. Notwithstanding the foregoing, all vesting and issuances or payments, as applicable, will be
completed no later than December 15 of the third calendar year commencing after an award date.
·
The RSU Plan provides that any unvested RSUs will vest at such time as determined by the Board in its sole discretion such that
participants in the RSU Plan will be able to participate in a change of control transaction, including by surrendering such RSUs to
the Company or a third party or exchanging such RSUs, for consideration in the form of cash and/or securities.
· Under the RSU Plan, should the vesting of an RSU fall within a blackout period or within nine business days following the
expiration of a blackout period, the vesting will be automatically extended to the tenth business day after the end of the blackout
period.
·
If an “event of termination” has occurred, any and all common shares corresponding to any vested RSUs in a participant’s account,
if any, will be issued as soon as practicable after the event of termination to the former participant. If an event of termination has
occurred, any unvested RSUs in the participant’s account will, unless otherwise determined by the Board in its discretion, forthwith
and automatically be forfeited by the participant and cancelled. Notwithstanding the foregoing, if a participant is terminated for just
cause, each unvested RSU in the participant’s account will be forfeited by the participant and cancelled. An “event of termination”
is defined under the RSU Plan as an event whereby a participant ceases to be eligible under the RSU Plan and is deemed to have
occurred by the giving of any notice of termination of employment (whether voluntary or involuntary and whether with or without
cause), retirement, or any cessation of employment for any reason whatsoever, including disability or death.
· No rights under the RSU Plan and no RSUs awarded pursuant to the provisions of the RSU Plan are assignable or transferable by
any participant other than pursuant to a will or by the laws of descent and distribution.
· Under the RSU Plan, the Board may from time to time in its absolute discretion amend, modify and change the provisions of the
RSU Plan or any RSUs awarded pursuant to the Plan, provided that any amendment will:
·
·
·
not adversely alter or impair any RSU previously awarded except as permitted by the adjustment provisions in the RSU
Plan;
be subject to any regulatory approvals including, where required, the approval of the TSX;
be subject to shareholder approval in accordance with the rules of the TSX in circumstances where the amendment,
modification or change to the RSU Plan or RSUs would:
(i)
allow for the assignment or transfer of any right under the RSU Plan or a RSU awarded pursuant to the provisions
of the RSU Plan other than as provided for under the assignability provisions in the RSU Plan;
-66-
(ii)
increase the fixed maximum number of common shares which may be issued pursuant to the RSU Plan; or
(iii)
amend the amendment provisions of the RSU Plan; and
·
not be subject to shareholder approval in circumstances (other than those listed in the paragraph immediately above), including, but
not limited to, circumstances where the amendment, modification or change to the RSU Plan or RSU would:
(i)
(ii)
(iii)
(iv)
(v)
(vi)
be of a “housekeeping nature”, including any amendment to the RSU Plan or a RSU that is necessary to comply
with applicable law or the requirements of any regulatory authority or stock exchange and any amendment to the
RSU Plan or a RSU to correct or rectify any ambiguity, defective provision, error or omission therein, including
any amendment to any definitions therein;
alter, extend or accelerate any vesting terms or conditions in the RSU Plan or any RSU;
change any termination provision in any RSU;
introduce features to the RSU Plan that would permit the Company to, instead of issuing common shares from
treasury upon the vesting of the RSUs, retain a broker and make payments for the benefit of participants to such
broker who would purchase common shares through the facilities of the TSX for such participants;
introduce features to the RSU Plan that would permit the Company to, instead of issuing common shares from
treasury upon the vesting of the RSUs, make lump sum cash payments to participants;
change the application of the adjustment provisions of the RSU Plan or the change of control provisions of the
RSU Plan; or
(vii)
change the eligible participants under the RSU Plan.
A copy of the RSU Plan is available upon request in writing to the Chief Financial Officer of the Company at 30 Worcester Road,
Toronto, Ontario, M9W 5X2.
The 330,000 common shares that are currently authorized under the RSU Plan represent approximately 1.4% of the Company’s
common shares issued and outstanding as at February 23, 2015. There are no RSUs outstanding as of February 23, 2015.
Deferred Share Unit Plan
The Company established as of May 28, 2010 when it received shareholder approval, a deferred share unit plan (the “ DSU Plan”)
to permit directors who are not officers of the Company, to defer receipt of all or a portion of their Board fees until termination of Board
service and to receive such fees in the form of common shares at that time.
The key features of the DSU Plan are as follows:
·
·
The DSU Plan is administered by the Board or a committee thereof. Members of the Board who are not salaried officers or
employees of the Company or a related corporation are eligible to participate under the DSU Plan. By the terms of the DSU Plan,
Dr. Isa Odidi and Dr. Amina Odidi are specifically not eligible to participate.
The number of common shares available for issuance upon redemption of DSUs issued under the DSU Plan is limited to 110,000
common shares of the Company, representing approximately 1% of the total number of issued and outstanding Common Shares as
of the date hereof.
-67-
·
·
·
·
·
Each participant may elect to be paid a minimum of 20% up to a maximum of 100%, in 10% increments, of Board fees in the form
of DSUs in lieu of being paid such fees in cash. On the date on which Board fees are payable (on a quarterly basis), the number of
DSUs to be credited to the participant is determined by dividing an amount equal to the designated percentage of the Board fees that
the participant has elected to have credited in DSUs on that fee payment date, by the calculated market value of a common share
(typically on the Toronto Stock Exchange) on that fee payment date. The market value of a common share is the weighted average
trading price of the common shares on any exchange where the common shares are listed (including the TSX) for the last five
trading days prior to such day. If dividends are declared by the Company, a participant will also be credited with dividend
equivalents in the form of additional DSUs based on the number of DSUs the participant holds on the record date for the payment
of a dividend. Dividend equivalents are calculated by dividing (i) the amount obtained by multiplying the amount of the dividend
declared and paid per common share by the number of DSUs in the participant’s account on the record date for the payment of such
dividend, by (ii) the market value of a common share on that dividend payment date. The market value of a common share is the
weighted average trading price of the common shares on any exchange where the common shares are listed (including the TSX) for
the last five trading days prior to such day.
A participant is permitted to redeem his/her DSUs only following termination of Board service by way of retirement, non-re-
election as a director, resignation or death. Upon redemption of DSUs, the Company will issue to the participant common shares of
the Company equal to the number of DSUs to be redeemed.
A separate notional account is maintained for each participant under the DSU Plan. Each such account will be credited with DSUs
issued to the participant from time to time by way of a bookkeeping entry in the books of the Company. The DSUs credited to the
participant’s account will be cancelled as of the applicable redemption date and following redemption of all DSUs credited to the
participant’s account, such participant’s account will be closed.
No rights under the DSU Plan and no DSUs credited pursuant to the provisions of the DSU Plan are assignable or transferable by
any participant other than pursuant to a will or by the laws of descent and distribution.
Under the DSU Plan, the Board may from time to time in its absolute discretion amend, modify and change the provisions of the
DSU Plan or any DSUs issued pursuant to the DSU Plan, provided that any amendment will:
·
·
·
·
not adversely alter or impair any DSU previously credited without such participant’s consent in writing except as
permitted by the adjustment provisions in the DSU Plan;
be subject to any regulatory approvals including, where required, the approval of the TSX;
be subject to shareholder approval in accordance with the rules of the TSX in circumstances where the
amendment, modification or change to the DSU Plan or DSU would:
(i)
(ii)
allow for the assignment or transfer of any right under the DSU Plan or a DSU credited pursuant to the
provisions of the DSU Plan other than as provided for under the assignability provisions in the DSU
Plan;
increase the fixed maximum number of common shares which may be issued pursuant to the DSU Plan;
or
(iii)
amend the amendment provisions of the DSU Plan; and
not be subject to shareholder approval in circumstances (other than those listed in the paragraph immediately
above), including, but not limited to, circumstances where the amendment, modification or change to the DSU
Plan or DSU would:
-68-
(i)
(ii)
be of a “housekeeping nature”, including any amendment to the DSU Plan or a DSU that is necessary to
comply with applicable law or the requirements of any regulatory authority or stock exchange and any
amendment to the DSU Plan or a DSU to correct or rectify any ambiguity, defective provision, error or
omission therein, including any amendment to any definitions therein;
introduce features to the DSU Plan that would permit the Company to, instead of issuing common shares
from treasury upon the redemption of the DSUs, retain a broker and make payments for the benefit of
participants to such broker who would purchase common shares through the facilities of the TSX for
such participants;
(iii)
introduce features to the DSU Plan that would permit the Company to, instead of issuing common shares
from treasury upon the redemption of the DSUs, make lump sum cash payments to participants;
(iv)
change the application of the adjustment provisions of the DSU Plan; or
(v)
change the eligible participants under the DSU Plan.
A copy of the DSU Plan is available upon request in writing to the Chief Financial Officer of the Company at 30 Worcester Road,
Toronto, Ontario, M9W 5X2.
The 110,000 common shares that are currently authorized under the DSU Plan represent approximately 0.5% of the Company’s
common shares issued and outstanding as at February 23, 2015. The total of 49,009 DSUs that have been authorized for issuance for the
period ended November 30, 2014 represent common share rights that comprise approximately 0.2% of the common shares issued and
outstanding as at February 23, 2015. As at February 23, 2015, 50,347 DSUs have been issued under the DSU Plan.
Item 7.
Major Shareholders and Related Party Transactions
A.
Major Shareholders
In March 2013 we completed a registered direct offering of units of common shares and warrants, in July 2013 we completed an
underwritten public offering of units of common shares and warrants, and in November 2013 we entered into an at-the-market equity
distribution agreement pursuant to which we may, from time to time, sell our common shares, all of which resulted in a significant change
in the percentage ownership of our principal shareholders, Drs. Amina and Isa Odidi, our President and Chief Operating Officer and our
Chairman and Chief Executive Officer, respectively, and Odidi Holdings Inc., a privately-held company controlled by Drs. Amina and Isa
Odidi (a decrease to approximately 28.0%) of our then-issued and outstanding common shares of the Company subsequent to the offering).
As of the date of this annual report, Drs. Amina and Isa Odidi, our President and Chief Operating Officer and our Chairman and Chief
Executive Officer, respectively, and Odidi Holdings Inc., a privately-held company controlled by Drs. Amina and Isa Odidi, own in the
aggregate directly and indirectly 5,997,751 common shares, representing approximately 25.5% of our issued and outstanding common
shares of the Company (and collectively beneficially owned in the aggregate approximately 9,006,115 common shares representing 34.0%
of our common shares including common shares issuable upon the exercise of outstanding options and the conversion of the outstanding
convertible debenture that are exercisable or convertible within 60 days of the date hereof). (Reference is made to the section entitled “E.
Share Ownership” under “Item 6. Directors, Senior Management and Employees” for additional information regarding the options to
purchase common shares and the convertible debenture held by Drs. Amina and Isa Odidi.) We believe Tekla Capital Management LLC
currently owns 2,184,000 common shares representing 9.3% of the issued and outstanding common shares as of the date of this annual
report (and beneficially owned approximately 2,964,000 common shares representing 12.2% of our common shares including common
shares issuable upon the exercise of outstanding warrants that are exercisable within 60 days of the date hereof). To our knowledge, no
other shareholder owns more than 5% of the issued and outstanding common shares of the Company.
-69-
There are no arrangements, known to the Company, the operation of which may at a subsequent date result in a change in control
of the Company.
No holder of common shares has different voting rights from any other holders of common shares.
As at December 31, 2014, there were a total of 352 holders of record of our common shares, of which 250 were registered with
addresses in Canada holding in the aggregate approximately 30% of our outstanding common shares, 53 were registered with addresses in
the United States holding in the aggregate approximately 70% of our outstanding common shares, and 49 were registered with addresses in
other nations holding in the aggregate less than 1% of our outstanding common shares. We believe that the number of beneficial owners of
our common shares is substantially greater than the number of record holders, because a large portion of our common shares are held in
broker “street names”.
B.
Related Party Transactions
As at November 30, 2014, we had repaid an outstanding related party loan payable to Dr. Isa Odidi and Dr. Amina Odidi, our
principal stockholders, directors and executive officers. Repayments of the related party loan were restricted under the terms of the loan
such that the principal amount thereof was payable when payment was required solely out of (i) revenues earned by IPC Corp following
the effective date of October 22, 2009 (“effective date”), and/or proceeds received by IPC Corp or its affiliates from the offering of its
securities after the effective date (other than the proceeds from the transactions completed in February 2011, March 2012, March 2013 and
July 2013), and/or amounts received by IPC Corp for scientific research tax credits of IPC Corp and (ii) up to C$800,000 of the Net Cash
from the Vasogen transaction (as defined in the IPC Arrangement Agreement). In March 2014, we repaid the entire outstanding related
party loan principal, in the amount of $690,049 (C$764,851) out of licensing revenues earned by IPC Corp and made interest payments of
$48,504 (C$53,762) in respect of the promissory note in accordance with the IPC Arrangement Agreement.
In addition, on January 10, 2013, we completed a private placement financing of an unsecured Debenture in the aggregate
principal amount of $1.5 million. The Debenture was originally due to mature on January 1, 2015, but effective October 1, 2014, the
maturity date was extended to July 1, 2015. The Debenture bears interest at a rate of 12% per annum, payable monthly, is pre-payable at
any time at the option of the Company, and is convertible at any time into 500,000 common shares at a conversion price of $3.00 per
common share at the option of the holder. Drs. Isa and Amina Odidi, our principal stockholders, directors and executive officers provided
us with the $1.5 million of the proceeds for the Debenture. The Company currently expects to repay this amount from then available cash
on or about July 1, 2015.
Since the beginning of the Company’s preceding three financial years to the date hereof, other than discussed above in this item 7,
there have been no transactions or proposed transactions which are material to the Company or to any associate, holder of 10% of the
Company’s outstanding shares, director or officer or any transactions that are unusual in their nature or conditions to which the Company or
any of its subsidiaries was a party.
Item 8.
Financial Information
A.
Consolidated Statements and Other Financial Information
Reference is made to “Item 18. Financial Statements” for the financial statements included in this annual report.
Legal Proceedings and Regulatory Actions
From time to time we may be exposed to claims and legal actions in the normal course of business. As of the date of this annual
report, we are not aware of any pending or threatened material litigation claims against us other than the ones described in the following
paragraphs.
Pursuant to an arrangement agreement between Vasogen and Cervus LP (“Cervus”) dated August 14, 2009 (the "Cervus
Agreement"), Vasogen and a Vasogen subsidiary (“New Vasogen”) entered into an indemnity
-70-
agreement (the "Indemnity Agreement"), which became an obligation of the Company as of October 22, 2009. The Indemnity Agreement
is designed to provide Cervus with indemnification for claims relating to Vasogen's and New Vasogen's business that are brought against
Cervus in the future, subject to certain conditions and limitations. The Company's obligations under the Indemnity Agreement relating to
the Tax pools defined in the Indemnity Agreement are limited to an aggregate of C$1,455,000 with a threshold amount of C$50,000 before
there is an obligation to make a compensation payment. The Company does not presently expect to have to pay any amount under this
Indemnity Agreement.
On or about August 8, 2014, Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. filed a complaint against
the Company for alleged patent infringement in the United States District Court for the District of Delaware in respect of
Intellipharmaceutics’ development of a generic of the branded drug Pristiq® (O-desmethylvenlafaxine succinate extended release tablets in
50 and 100 mg dosage strengths). A similar complaint for patent infringement was filed on August 11, 2014 by the same parties in the
District Court for the Southern District of New York. The above-noted litigation has been settled effective February 2, 2015, and the
Parties have stipulated to the full and final dismissal of all litigation noted above, without prejudice and without costs. All other terms of
the settlement are confidential.
On or about September 26, 2014, Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. and Angelini Pharma Inc. filed a
complaint against the Company for alleged patent infringement in the United States District Court for the District of Delaware in respect of
Intellipharmaceutics’ development of a generic of the branded drug Oleptro™ (trazodone hydrochloride extended-release tablets in 150 and
300 mg dosage strengths). The complaint was filed by the plaintiffs and subsequently served. The Company believes that the likelihood of
having to pay any damages or other penalty to the plaintiffs in connection with the resolution of this complaint in its anticipated course is
remote, although no assurance can be provided to this effect. The parties are engaged in settlement discussions, although we cannot predict
whether these discussions will result in a settlement.
Dividend Policy
The Company has not paid, and has no current plans to pay, dividends on its common shares. We currently intend to retain future
earnings, if any, to finance the development of our business. Any future dividend policy will be determined by our board of directors, and
will depend upon, among other factors, our earnings, if any, financial condition, capital requirements, any contractual restrictions with
respect to the payment of dividends, the impact of the distribution of dividends on our financial condition, tax liabilities, and such
economic and other conditions as our board of directors may deem relevant.
B.
Significant changes
No significant changes occurred since the date of our annual consolidated financial statements included elsewhere in this annual
report.
Item 9.
The Offer and Listing
Not Applicable, except for Item 9.A.4 and Item 9.C.
Our common shares are currently listed on NASDAQ and on the TSX under the symbols “IPCI” and “I”, respectively. Our shares
began trading on October 22, 2009, when the transaction with Vasogen was completed. The following table indicates, for the relevant
periods, the high and low prices of our common shares on NASDAQ and on the TSX:
Annual
2014
2013
2012
2011
2010
NASDAQ (U.S.$)
High
5.18
6.46
3.82
6.12
5.05
Low
1.94
1.50
1.88
2.30
1.41
TSX (C$)
High
5.77
6.70
3.55
6.05
5.36
Low
2.14
1.55
1.81
2.21
1.50
-71-
Quarterly
2014
Fourth quarter
Third quarter
Second quarter
First quarter
2013
Fourth quarter
Third quarter
Second quarter
First quarter
2012
Fourth quarter
Third quarter
Second quarter
First quarter
2011
Fourth quarter
Third quarter
Second quarter
First quarter
2010
Fourth quarter
Third quarter
Second quarter
First quarter
Most recent 6 months
February 2015 (through to February 23, 2015)
January 2015
December 2014
November 2014
October 2014
September 2014
August 2014
-72-
4.48
5.18
4.19
3.80
6.46
3.72
2.23
2.59
3.16
3.49
3.19
3.82
3.05
3.21
1.94
2.51
1.63
1.50
1.57
1.72
1.88
2.40
2.64
2.41
4.17
4.49
5.77
4.82
6.70
3.84
2.35
2.56
3.17
3.54
3.38
3.55
2.77
2.14
3.53
3.28
1.72
1.55
1.60
1.77
1.81
2.49
2.51
2.53
3.50
4.35
5.25
6.12
2.66
2.50
2.87
2.30
3.59
4.20
5.04
6.05
2.43
2.21
2.76
2.41
3.26
3.30
5.05
2.63
2.11
2.05
1.45
1.41
3.35
3.39
5.36
2.66
2.20
2.15
1.50
1.50
NASDAQ (U.S.$)
High
2.90
2.57
2.94
2.96
3.13
3.80
2.67
Low
2.08
1.96
2.21
2.65
2.52
2.51
1.94
TSX (C$)
High
3.30
3.04
3.33
3.32
3.51
4.17
2.98
Low
2.68
2.49
2.58
3.00
2.90
2.77
2.14
Item 10.
Additional Information
A.
Share Capital
Our authorized share capital consists of an unlimited number of common shares, all without nominal or par value and an unlimited
number of preference shares issuable in series. At November 30, 2014, 23,456,611 common shares and no preference shares were issued
and outstanding compared to 21,430,611 common and no preference shares issued and outstanding at December 1, 2013. As at February 23,
2015, there were 23,541,611 common shares and no preference shares issued and outstanding.
The reason for the increase in common shares issued was in November 2013, we established an at-the-market equity program
pursuant to which we could sell up to 5,305,484 of our common shares for up to an aggregate of $16.8 million (or such lesser amount as
may be permitted under applicable securities laws and regulations). As of the date of this annual report we have issued and sold 1,689,500
common shares with an aggregate offering price of $6,571,673 under the at-the-market program. Roth received compensation of $181,003
in connection with such sales. There can be no assurance that any additional shares will be sold under our at-the-market program.
Common Shares
Each of our common shares entitles the holder thereof to one vote at any meeting of shareholders of the Company, except
meetings at which only holders of a specified class of shares are entitled to vote. Common shares are entitled to receive, as and when
declared by the board of directors, dividends in such amounts as shall be determined by the board of directors. The holders of common
shares have the right to receive the remaining property of the Company in the event of liquidation, dissolution, or winding-up of the
Company, whether voluntary or involuntary.
Preference Shares
The preference shares may at any time and from time to time be issued in one or more series. The board of directors will, by
resolution, from time to time, before the issue thereof, fix the rights, privileges, restrictions and conditions attaching to the preference shares
of each series. Except as required by law, the holders of any series of preference shares will not as such be entitled to receive notice of,
attend or vote at any meeting of the shareholders of the Company. Holders of preference shares will be entitled to preference with respect
to payment of dividends and the distribution of assets in the event of liquidation, dissolution or winding-up of the Company, whether
voluntary or involuntary, or any other distribution of the assets of the Company among its shareholders for the purpose of winding up its
affairs, on such shares over the common shares and over any other shares ranking junior to the preference shares.
Warrants
At November 30, 2014, an aggregate of 2,291,075 common shares were issuable upon the exercise of outstanding common share
purchase warrants, with a weighted average exercise price of $2.43 per common share. At February 23, 2015, an aggregate of 2,291,075
common shares were issuable upon the exercise of outstanding common share purchase warrants, with a weighted average exercise price of
$2.43 per common share.
Options
At November 30, 2014, an aggregate of 4,858,208 common shares were issuable upon the exercise of outstanding options, with a
weighted average exercise price of $3.96 per common share. Up to 251,393 additional common shares are reserved for issuance under our
stock option plan.
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Exercise
price
Under 2.50
2.51 - 5.00
5.01 - 10.00
10.01 - 100.00
300.00 - 500.00
500.01 - 1,000.00
Weighted
average
exercise
price per
share
$
-
3.43
-
39.75
331.15
770.13
3.96
Weighted
average
remaining
contract
life (years)
-
2.40
-
2.87
1.30
0.29
Number
outstanding
$
-
4,818,501
-
35,703
3,971
33
4,858,208
Options
outstanding
Weighted
average
grant
due
fair value
$
Options
exercisable
Weighted Weighted
average
grant
date
fair value
$
average
exercise
price per
share
$
Number
exercisable
-
-
1.80 3,600,674
-
35,703
3,971
33
3,640,381
-
31.19
223.52
493.31
-
3.36
-
39.75
331.15
770.13
4.09
-
1.87
-
31.19
223.52
493.31
As of February 23, 2015, there were 3,542,881 common shares issuable upon the exercise of outstanding options. The weighted
average exercise price of these options is $4.11 per common share. As at February 23, 2015, up to 384,061 additional common shares were
reserved for issuance under our Option Plan.
Convertible Debenture
On January 10, 2013, we completed a private placement financing of an unsecured Debenture in the aggregate principal amount of
$1.5 million. The Debenture was originally due to mature on January 1, 2015, but effective October 1, 2014, the maturity date was
extended to July 1, 2015. The Debenture bears interest at a rate of 12% per annum, payable monthly, is pre-payable at any time at the
option of the Company, and is convertible at any time into 500,000 common shares at a conversion price of $3.00 per common share at the
option of the holder. Drs. Isa and Amina Odidi, our principal stockholders, directors and executive officers provided us with the $1.5
million of the proceeds for the Debenture. The Company currently expects to repay this amount from then available cash on or about July
1, 2015.
Deferred Share Units
At November 30, 2014, there were 49,009 DSUs issued to one non-management director. From November 30, 2014 to the date of
this annual report, an additional 1,338 DSUs have been issued. At the date of this annual report, 59,653 additional DSUs are reserved for
issuance under our DSU plan.
Restricted Share Units
At November 30, 2014, there were no RSUs issued. From November 30, 2014 to the date of this report, no RSUs have been
issued. At the date of this report, 330,000 RSUs are reserved for issuance under our RSU Plan.
Registration Rights
We conducted a private placement issuance of units comprised of common shares and warrants in February, 2011, which was
exempt from registration under the U.S. Securities Act pursuant to Regulation D and Section 4(2) and/or Regulation S thereof and such
other available exemptions. As such, the common shares, the warrants, and the common shares underlying the warrants may not be offered
or sold in the United States unless they are registered under the U.S. Securities Act, or an exemption from the registration requirements of
the U.S. Securities Act is available.
In connection with the private placement, we agreed to file a registration statement on Form F-3 (“Registration Statement”)
within 40 days after the closing and use our best efforts to have it declared effective within 150 days after the closing to register (i) 100%
of the common shares issued in the private placement; and (ii) 100% of the common shares underlying the investor warrants issued in the
private placement (collectively, the private placement or the “Registrable Securities”).
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The Registration Statement was declared effective as of March 30, 2011. If (i) the Registration Statement ceases to be
continuously effective for more than twenty consecutive calendar days or more than an aggregate of thirty calendar days during any
consecutive 12-month period, or (ii) at a time in which the Registrable Securities cannot be sold under the Registration Statement, we shall
fail for any reason to satisfy the current public information requirement under Rule 144 as to the applicable Registrable Securities, we shall
pay to the investors, on a pro rata basis, partial liquidated damages of one percent (1%) of the aggregate purchase price paid by each
investor on the occurrence of an event listed above and for each calendar month (pro rata for any period less than a calendar month) from
an event, until cured.
The securities shall cease to be Registrable Securities when (i) they have been sold (A) pursuant to a registration statement; or (B)
in accordance with Rule 144 or any other rule of similar effect; or (ii) such securities become eligible for resale without volume or manner-
of-sale restrictions, and when either we are compliant with any current public information requirements pursuant to Rule 144 or the current
public information requirements no longer apply.
Prior Sales
On March 15, 2012, we completed a registered direct common share offering for gross proceeds of $5,000,000. We sold an
aggregate of 1,818,182 shares to U.S. institutional investors at a price of $2.75 per share.
In January 2013, we completed a private placement financing of a Debenture in the aggregate principal amount of $1.5 million.
The Debenture was originally due to mature on January 1, 2015, but effective October 1, 2014, the maturity date was extended to July 1,
2015.. The Debenture bears interest at a rate of 12% per annum, payable monthly, is pre-payable at any time at our option, and is
convertible at any time into 500,000 common shares at a conversion price of US$3.00 per common share at the option of the holder. Drs.
Isa and Amina Odidi, our principal stockholders, directors and executive officers provided us with the $1.5 million of the proceeds for the
Debenture.
In March 2013, we completed a registered direct unit offering for gross proceeds of $3,121,800. We sold an aggregate of
1,815,000 units at a price of $1.72 per unit. The units were comprised of an aggregate of 1,815,000 common shares and warrants to
purchase an additional 453,750 common shares. The warrants are exercisable for a term of five years and have an exercise price of $2.10
per common share.
In July 2013, we completed an underwritten public offering of 1,500,000 units of common shares and warrants for gross proceeds
of $3,075,000 at a price of $2.05 per unit. The units were comprised of an aggregate of 1,500,000 common shares and warrants to purchase
an additional 375,000 common shares. The warrants have a term of five years and an exercise price of $2.55 per common share.
In November 2013, we entered into an equity distribution agreement with Roth, pursuant to which we may from time to time sell
up to 5,305,484 of our common shares for up to an aggregate of $16.8 million (or such lesser amount as may be permitted under applicable
securities laws and regulations) through at-the-market issuances on the NASDAQ or otherwise. Under the equity distribution agreement,
we may at our discretion, from time to time, offer and sell common shares through Roth or directly to Roth for resale. Sales of common
shares through Roth, if any, will be made at such time and at such price as are acceptable to us, from time to time, by means of ordinary
brokers’ transactions on the NASDAQ or otherwise at market prices prevailing at the time of sale or as determined by us. We currently
plan to use any net proceeds from the at-the-market offering for general corporate purposes, including funding research, product
development and other corporate development opportunities and to possibly fund costs and other expenses relating to our current leased
facility or any additional space, and, although we have no present understanding, commitments or agreements to do so, potential
acquisition of, or investment in, companies and technologies that complement our business. We are not required to sell shares under the
equity distribution agreement. We will pay Roth a commission, or allow a discount, of 2.75% of the gross proceeds we receive from any
sales of our common shares under the equity distribution agreement. Any sales of shares under our at-the-market offering program will be
made pursuant to an effective shelf registration statement on Form F-3 filed with the SEC. We have also agreed to reimburse Roth for
certain expenses relating to the offering. As of the date of this annual report, we have issued and sold 1,689,500 common shares with an
aggregate offering price of $6,571,673 under the at-the-market program. As a result, we may offer and sell our common shares with an
aggregate purchase price of up to $10,228,327 pursuant to the at-the-market program. Roth received aggregate compensation of
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$181,003 in connection with such sales. There can be no assurance that any additional shares will be sold under our at-the-market program.
Subsequent to the year ended November 30, 2014, share issuance costs of Nil were recorded against the cost of the shares issued and
recognized in capital stock. As at November 30, 2014, $811,887 of the share issuance costs has been recorded against the cost of the shares
issued and recognized in capital stock.
On June 4, 2014, the Shelf Registration Statement was declared effective by the SEC and on June 5, 2014, the Company filed a
final short form base shelf prospectus with securities regulatory authorities in each of the provinces and territories of Canada, except
Quebec. These documents allow for, subject to securities regulatory requirements and limitations, the potential offering of up to an
aggregate of US$100 million of the Company's common shares, preference shares, warrants, subscription receipts and units, or any
combination thereof, from time to time in one or more offerings, and are intended to give the Company the flexibility to take advantage of
financing opportunities when, and if, market conditions are favorable to the Company. The specific terms of such future offerings, if any,
would be established, subject to the approval of the Company's board of directors, at the time of such offering and will be described in
detail in a prospectus supplement filed at the time of any such offering. To the extent that any securities are issued by the Company under
the shelf prospectus, a shareholder’s’ percentage ownership will be diluted and our stock price could be adversely affected. As of the date
of this annual report, the Company has not sold any securities under the Shelf Registration Statement or the shelf prospectus and there can
be no assurance that any securities will be sold under the Shelf Registration Statement or the shelf prospectus.
During the 12-month period ended November 30, 2014, warrants to purchase an aggregate of 288,500 common shares were
exercised.
During the 12-month period ended November 30, 2014, 479,001 options were granted and 48,000 options were exercised.
Also during the 12-month period ended November 30, 2014, a total of 5,969 deferred share units were granted.
B.
Articles and By-laws
The Company was formed under the Canada Business Corporations Act (the “CBCA”) by articles of arrangement dated October
22, 2009 (the “Articles”) in the IPC Arrangement Transaction discussed in Item 15. The Company is the successor issuer to Vasogen Inc.
for reporting purposes under the U.S. Exchange Act. The authorized share capital of the Company consists of an unlimited number of
common shares, all without nominal or par value and an unlimited number of preference shares issuable in series.
Provisions as to the modification, amendment or variation of rights and provisions of each class of shares are contained in the
CBCA and the regulations promulgated thereunder. Certain fundamental changes to the Articles will require the approval of at least two-
thirds of the votes cast on a resolution submitted to a special meeting of the Company’s shareholders called for the purpose of considering
the resolution. These items include (i) certain amendments to the provisions relating to the outstanding capital of the Company, (ii) a sale
of all or substantially all of the assets of the Company, (iii) an amalgamation of the Company with another company, other than a
subsidiary, (iv) a winding-up of the Company, (v) a continuance of the Company into another jurisdiction, (vi) a statutory court approved
arrangement under the CBCA (essentially a corporate reorganization such as an amalgamation, sale of assets, winding-up, etc.), or (vii) a
change of name.
Under the CBCA, a corporation cannot repurchase its shares or pay or declare dividends if there are reasonable grounds for
believing that (a) the corporation is, or after payment would be, unable to pay its liabilities as they become due, or (b) after the payment, the
realizable value of the corporation’s assets would be less than the aggregate of (i) its liabilities and (ii) its stated capital of all classes of its
securities. Generally, stated capital is the amount paid on the issuance of a share unless the stated capital has been adjusted in accordance
with the CBCA.
General
The Articles do not contain any restrictions on the business the Company may carry on.
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Directors
The Company’s By-Law No. 1 (a by-law relating generally to the transaction of the business and affairs of the Company) provides
for the indemnification of the directors and officers of the Company, former directors and officers of the Company against all costs,
charges and expenses, including an amount paid to settle an action or satisfy a judgment, reasonably incurred by the individual in respect of
any civil, criminal, administrative, investigative or other proceeding in which the individual is involved because of that association with the
Company, subject to certain limitations in By-Law No. 1 and the limitations in the CBCA.
The Company may also indemnify other individuals who act or acted at the Company’s request as a director or officer, or an
individual acting in a similar capacity, of another entity.
Annual and Special Meetings
Meetings of shareholders are held at such place, at such time, on such day and in such manner as the Board may, subject to the
CBCA and any other applicable laws, determine from time to time. The only persons entitled to attend a meeting of shareholders are those
persons entitled to notice thereof, those entitled to vote thereat, the directors, the auditors of the Company and any others who may be
entitled or required under the CBCA to be present at the meeting. Under the CBCA, notice of the meeting is required to be given not less
than 21 days and not more than 60 days prior to the meeting. Shareholders on the record date are entitled to attend and vote at the meeting.
The quorum for the transaction of business at any meeting of shareholders is at least two persons present at the opening of the meeting
who are entitled to vote either as shareholders or proxyholders, representing collectively not less than 5% of the outstanding shares of the
Company entitled to be voted at the meeting.
Other
There is no by-law provisions governing the ownership threshold above which shareholder ownership must be disclosed.
However, there are disclosure requirements pursuant to applicable Canadian law.
There are no provisions in either the Company’s Articles or By-Law No. 1 that would have the effect of delaying, deferring or
preventing a change in control of the Company and that would operate only with respect to a merger, acquisition or corporate restructuring
involving the Company or its subsidiary.
There are no limitations on the rights to own securities, including the rights of non-resident or foreign shareholders to hold or
exercise voting rights on the securities imposed by foreign law or by the charter or other constituent document of the Company.
C.
Material Contracts
Except for contracts entered into in the ordinary course of business and not required to be filed under Canadian securities laws, the only
contracts which are regarded as material and which were entered into by the Company within the two years immediately preceding the date
of this annual report, are:
• On November 21, 2005, the Company entered into the Par agreement pursuant to which the Company granted Par an exclusive,
royalty-free license to make and distribute in the United States all strengths of our generic versions of the branded product Focalin
XR® for a period of 10 years from the date of commercial launch (which was November 19, 2013). Under the Par agreement, the
Company owns the related ANDA, as approved by the FDA, and the Company retains the right to make and distribute all generic
strengths of the product outside of the United States. Quarterly payments are payable by Par to the Company as calculated pursuant
to a formula depending on a number of factors applicable to each strength. The Par agreement also provides the potential, in limited
circumstances, for certain milestone payments being payable to the Company by Par, with the amount of such payments dependent
upon the number of competitors in the market within the first 180 days of commercialization, on a strength by strength basis. The
Company is responsible under the Par agreement for the development of the product and most related costs which, with the
applications to and recent approvals by the FDA, the Company now considers to be completed;
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•
•
•
The acknowledgement and agreement of the Company dated October 22, 2009 to be bound by the performance based stock option
agreement dated September 10, 2004 pursuant to which Drs. Isa and Amina Odidi are entitled to purchase up to 2,763,940 of the
Company’s shares upon payment of $3.62 per share, subject to satisfaction of the performance vesting conditions being the
acceptance by the FDA of the filing of an application for approval of a drug product or the approval of such an application;
The amended and restated promissory note dated October 22, 2009 for up to C$2,300,000 issued by IPC Corp to Isa Odidi and
Amina Odidi for advances that may be made by them from time to time to the Company. As at November 30, 2014, no amount was
outstanding. No at-the-market offering proceeds were used in payment of the promissory note; and
The Debenture dated January 10, 2013 for $1.5 million, which will (as extended) mature July 1, 2015 issued by the Company to Isa
Odidi and Amina Odidi for the loan of $1.5 million made by them to the Company.
D.
Exchange Controls
Canada has no system of currency exchange controls. There are no governmental laws, decrees or regulations in Canada that
restrict the export or import of capital, including but not limited to, foreign exchange controls, or that affect the remittance of dividends,
interest or other payments to non-resident holders of the Company’s securities.
E.
Taxation
United States Taxation
Certain Material United States Federal Income Tax Considerations
The following discussion is a general summary of certain material United States federal income tax considerations applicable to a
U.S. holder arising from and relating to the consequences of the ownership and disposition of our common shares and warrants that are
generally applicable to a United States person that holds our common shares as capital assets (a “U.S. Holder”) within the meaning of
Section 1221 of the Code. This discussion does not address holders of other securities. This discussion assumes that we are not a
“controlled foreign corporation” for U.S. federal income tax purposes. The following discussion does not purport to be a complete analysis
of all of the potential United States federal income tax considerations that may be relevant to particular holders of our common shares or
warrants in light of their particular circumstances nor does it deal with persons that are subject to special tax rules, such as brokers, dealers
in securities or currencies, financial institutions, insurance companies, tax-exempt organizations, persons liable for alternative minimum
tax, U.S. expatriates, partnerships or other pass-through entities, U.S. Holders who own (directly, indirectly or by attribution) ten percent or
more of the total combined voting power of all classes of stock entitled to vote, persons holding our common shares as part of a straddle,
hedge or conversion transaction or as part of a synthetic security or other integrated transaction, traders in securities that elect to use a
mark-to-market method of accounting for their securities holdings, holders whose “functional currency” is not the United States dollar, and
holders who are not U.S. Holders. In addition, the discussion below does not address the tax consequences of the law of any state, locality
or foreign jurisdiction or United States federal tax consequences (e.g., estate or gift tax) other than those pertaining to the income tax.
There can be no assurance that the United States Internal Revenue Service (the “IRS”) will take a similar view as to any of the tax
consequences described in this summary.
The following is based on currently existing provisions of the Code, existing and proposed Treasury regulations under the Code
and current administrative rulings and court decisions. Everything listed in the previous sentence may change, possibly on a retroactive
basis, and any change could affect the continuing validity of this discussion.
Each U.S. Holder and each holder of common shares that is not a U.S. Holder should consult its tax adviser regarding the United
States federal income tax consequences of holding our common shares applicable to such holder in light of its particular situation, as well
as any tax consequences that may arise under the laws of any other relevant foreign, state, local, or other taxing jurisdiction.
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As used in this section, the term “United States person” means a beneficial owner of our common shares that is:
(i)
(ii)
(iii)
(iv)
a citizen or an individual resident of the United States;
a corporation (or an entity taxable as a corporation for United States federal income tax purposes) created or organized in
or under the laws of the United States or any political subdivision of the United States;
an estate the income of which is subject to United States federal income taxation regardless of its source; or
a trust which (A) is subject to the supervision of a court within the United States and the control of a United States person
as described in Section 7701(a)(30) of the Code; or (B) is subject to a valid election under applicable Treasury Regulations
to be treated as a United States person.
If a partnership (including for this purpose any entity treated as a partnership for U.S. federal income tax purposes) holds our
common shares, the United States federal income tax treatment of a partner generally will depend on the status of the partner and the
activities of the partnership. A United States person that is a partner of the partnership holding our common shares should consult its own
tax adviser.
Passive Foreign Investment Company Considerations
Special, generally unfavorable, U.S. federal income tax rules apply to the ownership and disposition of the stock or warrants of a
passive foreign investment company (“PFIC”). As discussed below, however, a U.S. Holder of our common shares (but not our warrants)
may be able to mitigate these consequences by making a timely and effective election to treat the Company as a qualified electing fund (a
“QEF Election”) or by making a timely and effective mark-to-market election with respect to its common shares.
For U.S. federal income tax purposes, a foreign corporation is classified as a PFIC for each taxable year in which, applying the
relevant look-through rules, either:
·
·
at least 75% of its gross income for the taxable year consists of specified types of “passive” income (referred to as the
“income test”); or
at least 50% of the average value of its assets during the taxable year is attributable to certain types of assets that produce
passive income or are held for the production of passive income (referred to as the “asset test”).
For purposes of the income and asset tests, if a foreign corporation owns directly or indirectly at least 25% (by value) of the stock
of another corporation, that foreign corporation will be treated as if it held its proportionate share of the assets of the other corporation and
received its proportionate share of the income of that other corporation. Also, for purposes of the income and asset tests, passive income
does not include any income that is an interest, dividend, rent or royalty payment if it is received or accrued from a related person to the
extent that amount is properly allocable to the active income of the related person. Under applicable attribution rules, if the Company is a
PFIC, U.S. Holders of common shares will be treated as holding stock of the Company’s subsidiaries that are PFICs in certain
circumstances. In these circumstances, certain dispositions of, and distributions on, stock of such subsidiaries may have consequences for
U.S. Holders under the PFIC rules.
Although the matter is not free from doubt, we believe that we were not a PFIC during our 2014 taxable year and may not be a
PFIC during our 2015 taxable year. Because PFIC status is based on our income, assets and activities for the entire taxable year, and our
market capitalization, it is not possible to determine whether we will be characterized as a PFIC for the 2015 taxable year until after the
close of the taxable year. The tests for determining PFIC status are subject to a number of uncertainties. These tests are applied annually,
and it is difficult to accurately predict future income, assets and activities relevant to this determination. In addition, because the market
price of our common shares is likely to fluctuate, the market price may affect the determination of whether we will be considered a PFIC.
There can be no assurance that we will not be considered a PFIC for any taxable year (including our 2015 taxable year). Absent one of the
elections described below, if we are a PFIC for any taxable year during
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which a U.S. Holder holds our common shares, we generally will continue to be treated as a PFIC subject to the regime described below
with respect to such U.S. Holder, regardless of whether we cease to meet the PFIC tests in one or more subsequent years. Accordingly, no
assurance can be given that we will not constitute a PFIC in the current (or any future) tax year or that the IRS will not challenge any
determination made by us concerning our PFIC status.
If we are a PFIC, the U.S. federal income tax consequences to a U.S. Holder of the ownership and disposition of our shares will
depend on whether such U.S. Holder makes a QEF or mark-to-market election. Unless otherwise provided by the IRS, a U.S. Holder of our
shares is generally required to file an informational return annually to report its ownership interest in the PFIC during any year in which we
are a PFIC.
U.S. HOLDERS SHOULD CONSULT THEIR OWN TAX ADVISERS ABOUT THE PFIC RULES, THE POTENTIAL
APPLICABILITY OF THESE RULES TO THE COMPANY CURRENTLY AND IN THE FUTURE, AND THEIR FILING
OBLIGATIONS IF THE COMPANY IS A PFIC.
The “No Election” Alternative – Taxation of Excess Distributions
If we are classified as a PFIC for any year during which a U.S. Holder has held common shares or warrants and, in the case of our
common shares, that U.S. Holder has not made a QEF Election or a mark-to-market election, special rules may subject that U.S. Holder to
increased tax liability, including loss of favorable capital gains rates and the imposition of an interest charge upon the sale or other
disposition of the common shares or warrants or upon the receipt of any excess distribution (as defined below). Under these rules:
·
·
·
·
the gain, if any, realized on such disposition will be allocated ratably over the U.S. Holder’s holding period;
the amount of gain allocated to the current taxable year and any year prior to the first year in which we are a PFIC will be
taxed as ordinary income in the current year;
the amount of gain allocated to each of the other taxable years will be subject to tax at the highest ordinary income tax rate
in effect for that year; and
an interest charge for the deemed deferral benefit will be imposed with respect to the resulting tax attributable to each of the
other taxable years.
These rules will continue to apply to the U.S. Holder even after we cease to meet the definition of a PFIC, unless the U.S. Holder elects to
be treated as having sold our common shares on the last day of the last taxable year in which we qualified as a PFIC.
An “excess distribution,” in general, is any distribution on common shares received in a taxable year by a U.S. Holder that is
greater than 125% of the average annual distributions received by that U.S. Holder in the three preceding taxable years or, if shorter, that
U.S. Holder’s holding period for common shares.
Any portion of a distribution paid to a U.S. Holder that does not constitute an excess distribution will be treated as ordinary
dividend income to the extent of our current and accumulated earnings and profits (as computed for U.S. federal income tax purposes).
Such dividends generally will not qualify for the dividends-received deduction otherwise available to U.S. corporations. Any amounts
treated as dividends paid by a PFIC generally will not constitute “qualified dividend income” within the meaning of Section 1(h)(11) of the
Code and will, therefore, not be eligible for the preferential 20% rate for such income generally in effect under current law. Any such
amounts in excess of our current and accumulated earnings and profits will be applied against the U.S. Holder’s tax basis in the common
shares and, to the extent in excess of such tax basis, will be treated as gain from a sale or exchange of such shares. It is possible that any
such gain may be treated as an excess distribution.
The QEF Election Alternative
A U.S. Holder of common shares (but not warrants) who elects (an “Electing U.S. Holder”) in a timely manner to treat us as a
QEF would generally include in gross income (and be subject to current U.S. federal income tax on) its pro rata share of (a) the Company’s
ordinary earnings, as ordinary income, and (b) our net capital gains, as long-term capital gain. An Electing U.S. Holder will generally be
subject to U.S. federal income tax on such
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amounts for each taxable year in which we are classified as a PFIC, regardless of whether such amounts are actually distributed to the
Electing U.S. Holder. An Electing U.S. Holder may further elect, in any given taxable year, to defer payment of U.S. federal income tax on
such amounts, subject to certain limitations. However, if deferred, the taxes will be subject to an interest charge.
A U.S. Holder may not make a QEF election with respect to its warrants to acquire our common shares. As a result, if a U.S.
Holder sells or otherwise disposes of such warrants (other than upon exercise of such warrants), any gain recognized generally will be
subject to the special tax and interest charge rules treating the gain as an excess distribution, as described above, if we were a PFIC at any
time during the period the U.S. Holder held the warrants. If a U.S. Holder that exercises such warrants properly makes a QEF election with
respect to the newly acquired common shares (or has previously made a QEF election with respect to our common shares), the QEF
election will apply to the newly acquired common shares, but the adverse tax consequences relating to PFIC common shares, adjusted to
take into account the current income inclusions resulting from the QEF election, will continue to apply with respect to such newly acquired
common shares (which generally will be deemed to have a holding period for purposes of the PFIC rules that includes the period the U.S.
Holder held the warrants), unless the U.S. Holder makes a purging election under the PFIC rules. The purging election creates a deemed
sale of such common shares at their fair market value. The gain recognized by the purging election will be subject to the special tax and
interest charge rules treating the gain as an excess distribution, as described above. As a result of the purging election, the U.S. Holder will
have a new basis and holding period in the common shares acquired upon the exercise of the warrants for purposes of the PFIC rules.
A U.S. Holder may make a QEF Election only if the Company furnishes the U.S. Holder with certain tax information. If the
Company should determine that it is a PFIC, it is anticipated that it will attempt to timely and accurately disclose such information to its
U.S. Holders and provide U.S. Holders with information reasonably required to make such election.
A U.S. Holder that makes a QEF Election with respect to the Company generally (a) may receive a tax-free distribution from the
Company to the extent that such distribution represents “earnings and profits” of the Company that were previously included in income by
the U.S. Holder because of such QEF Election and (b) will adjust such U.S. Holder’s tax basis in his, her or its common shares to reflect the
amount included in income (resulting in an increase in basis) or allowed as a tax-free distribution (resulting in a decrease in basis) because
of the QEF Election.
Similarly, if any of our non-U.S. subsidiaries were classified as PFICs, a U.S. Holder that makes a timely QEF Election with
respect to any of our subsidiaries would be subject to the QEF rules as described above with respect to the Holder’s pro rata share of the
ordinary earnings and net capital gains of any of our subsidiaries. Our earnings (or earnings of any of our subsidiaries) attributable to
distributions from any of our subsidiaries that had previously been included in the income of an Electing U.S. Holder under the QEF rules
would generally not be taxed to the Electing U.S. Holder again.
Upon the sale or other disposition of common shares, an Electing U.S. Holder who makes a QEF Election for the first taxable year
in which he owns common shares will recognize capital gain or loss for U.S. federal income tax purposes in an amount equal to the
difference between the net amount realized on the disposition and the U.S. Holder’s adjusted tax basis in the common shares. Such gain or
loss will be long-term capital gain or loss if the U.S. Holder’s holding period in the common shares is more than one year, otherwise it will
be short-term capital gain or loss. The deductibility of capital losses is subject to certain limitations. A U.S. Holder’s gain realized upon the
disposition of shares generally will be treated as U.S. source income, and losses from the disposition generally will be allocated to reduce
U.S. source income.
A QEF Election must be made in a timely manner as specified in applicable Treasury Regulations. Generally, the QEF Election
must be made by filing the appropriate QEF election documents at the time such U.S. Holder timely files its U.S. federal income tax return
for the first taxable year of the Company during which it was, at any time, a PFIC.
Each U.S. Holder should consult its own tax advisor regarding the availability of, procedure for making, and consequences of a
QEF Election with respect to the Company.
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Mark-to-Market Election Alternative
Assuming that our common shares are treated as marketable stock (as defined for these purposes), a U.S. Holder that does not
make a QEF Election may avoid the application of the excess distribution rules, at least in part, by electing to mark the common shares to
market annually. Consequently, the U.S. Holder will generally recognize as ordinary income or loss each year an amount equal to the
difference as of the close of the taxable year between the fair market value of its common shares and the U.S. Holder’s adjusted tax basis in
the common shares. Any mark-to-market loss is treated as an ordinary deduction, but only to the extent of the net mark-to-market gain that
the Holder has included pursuant to the election in prior tax years. Any gain on a disposition of our common shares by an electing U.S.
Holder would be treated as ordinary income. The electing U.S. Holder’s basis in its common shares would be adjusted to reflect any of
these income or loss amounts. Currently, a mark-to-market election may not be made with respect to warrants. We do not anticipate that the
preference shares will be treated as marketable stock for these purposes.
For purposes of making this election, stock of a foreign corporation is “marketable” if it is “regularly traded” on certain “qualified
exchanges”. Under applicable Treasury Regulations, a “qualified exchange” includes a national securities exchange that is registered with
the SEC or the national market system established pursuant to Section 11A of the U.S. Exchange Act, and certain foreign securities
exchanges. Currently, our common shares are traded on a “qualified exchange.” Under applicable Treasury Regulations, PFIC stock traded
on a qualified exchange is “regularly traded” on such exchange for any calendar year during which such stock is traded, other than in de
minimis quantities, on at least 15 days during each calendar quarter. Special rules apply if an election is made after the beginning of the
taxpayer’s holding period in PFIC stock.
To the extent available, a mark-to-market election applies to the taxable year in which such mark-to-market election is made and to
each subsequent taxable year, unless the Company’s common shares cease to be “marketable stock” or the IRS consents to revocation of
such election. In addition, a U.S. Holder that has made a mark-to-market election does not include mark-to-market gains, or deduct mark-to-
market losses, for years when the Company ceases to be treated as a PFIC.
The mark-to-market rules generally do not appear to prevent the application of the excess distribution rules in respect of stock of
any of our subsidiaries in the event that any of our subsidiaries were considered PFICs. Accordingly, if Intellipharmaceutics and any of our
subsidiaries were both considered PFICs and a U.S. Holder made a mark-to-market election with respect to its common shares, the U.S.
Holder may remain subject to the excess distribution rules described above with respect to its indirectly owned shares of subsidiary stock.
U.S. HOLDERS ARE URGED TO CONSULT THEIR TAX ADVISORS REGARDING THE POSSIBLE APPLICABILITY OF THE
PFIC RULES AND THE AVAILABILITY OF, PROCEDURES FOR MAKING, AND CONSEQUENCES OF A QEF ELECTION OR
MARK-TO-MARKET ELECTION WITH RESPECT TO THE COMPANY’S COMMON SHARES.
Ownership and Disposition of Common Shares and Warrants to the Extent that the PFIC Rules do not Apply
Distributions on Common Shares
A U.S. Holder that receives a distribution, including a constructive distribution, with respect to a Share will be required to include
the amount of such distribution in gross income as a dividend (without reduction for any Canadian income tax withheld from such
distribution) to the extent of the current or accumulated “earnings and profits” of the Company, as computed for U.S. federal income tax
purposes. To the extent that a distribution exceeds the current and accumulated “earnings and profits” of the Company, such distribution
will be treated first as a tax-free return of capital to the extent of a U.S. Holder’s tax basis in the common shares and thereafter as gain from
the sale or exchange of such common shares. (See “Sale or Other Taxable Disposition of Common Shares” below). However, the Company
may not maintain the calculations of earnings and profits in accordance with U.S. federal income tax principles, and each U.S. Holder
should (unless advised to the contrary) therefore assume that any distribution by the Company with respect to the common shares will
constitute ordinary dividend income. Dividends received on common shares generally will not be eligible for the “dividends received
deduction”. The dividend rules are complex, and each U.S. Holder should consult its own tax advisor regarding the application of such
rules.
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The terms of a warrant may provide for an adjustment to the number of common shares for which the warrant may be exercised or
to the exercise price of the warrant in certain events. An adjustment which has the effect of preventing dilution generally is not taxable.
However, the U.S. Holders of the warrants would be treated as receiving a constructive distribution from us if, for example, the adjustment
increases the warrant holders’ proportionate interest in our assets or earnings and profits (e.g., through an increase in the number of
common shares that would be obtained upon exercise) as a result of a distribution of cash to the holders of our common shares which is
taxable to the U.S. Holders of such common shares as described under “Distributions on Common Shares” above. Such constructive
distribution would be subject to tax as described under that section in the same manner as if the U.S. Holders of the warrants received a
cash distribution from us equal to the fair market value of such increased interest.
Sale or Other Taxable Disposition of Common Shares
Upon the sale or other taxable disposition of common shares, a U.S. Holder generally will recognize capital gain or loss in an
amount equal to the difference between the U.S. dollar value of cash received plus the fair market value of any property received and such
U.S. Holder’s tax basis in such common shares sold or otherwise disposed of. A U.S. Holder’s tax basis in common shares generally will
be such Holder’s U.S. dollar cost for such common shares.
Gain or loss recognized on such sale or other disposition generally will be long-term capital gain or loss if, at the time of the sale
or other disposition, the common shares have been held for more than one year. The long-term capital gains realized by non-corporate U.S.
Holders are generally subject to a lower marginal U.S. federal income tax rate than ordinary income other than qualified dividend income,
as defined above. Currently, the maximum rate on long-term capital gains is 20%, although the actual rates may be higher due to the phase
out of certain tax deductions, exemptions and credits. However, given the uncertain economic conditions in the United States and the size
of the federal deficit, tax rates are subject to change and prospective U.S. Holders should consult their tax advisors. The deductibility of
losses may be subject to limitations.
Warrants
Generally, no U.S. federal income tax will be imposed upon the U.S. Holder of a warrant upon exercise of such warrant to acquire
our common shares. A U.S. Holder’s tax basis in a warrant will generally be the amount of the purchase price that is allocated to the
warrant. Upon exercise of a warrant, the tax basis of the new common shares would be equal to the sum of the tax basis of the warrants in
the hands of the U.S. Holder plus the exercise price paid, and the holding period of the new common shares would begin on the date that
the warrants are exercised. If a warrant lapses without exercise, the U.S. Holder will generally realize a capital loss equal to its tax basis in
the warrant. Prospective U.S. Holders should consult their tax advisors regarding the tax consequences of acquiring, holding and disposing
of warrants.
The tax consequences of a cashless exercise of a warrant are not clear under current tax law. A cashless exercise may be tax-free,
either because the exercise is not a gain realization event or because the exercise is treated as a recapitalization for U.S. federal income tax
purposes. In either tax-free situation, a U.S. Holder’s basis in the common shares received would equal the U.S. holder’s basis in the
warrant. If the cashless exercise were treated as not being a gain realization event, a U.S. Holder’s holding period in the common shares
would be treated as commencing on the date following the date of exercise of the warrant. If the cashless exercise were treated as a
recapitalization, the holding period of the common shares would include the holding period of the warrant. It is also possible that a cashless
exercise could be treated as a taxable exchange in which gain or loss would be recognized. In such event, a U.S. Holder could be deemed to
have surrendered warrants equal to the number of common shares having a value equal to the exercise price for the total number of
warrants to be exercised. The U.S. Holder would recognize capital gain or loss in an amount equal to the difference between the fair market
value of the common shares represented by the warrants deemed surrendered and the U.S. Holder’s tax basis in the warrants deemed
surrendered. In this case, a U.S. Holder’s tax basis in the common shares received would equal the sum of the fair market value of the
common shares represented by the warrants deemed surrendered and the U.S. Holder’s tax basis in the warrants exercised. A U.S. Holder’s
holding period for the common shares would commence on the date following the date of exercise of the warrant. Due to the absence of
authority on the U.S. federal income tax treatment of a cashless exercise, there can be no assurance which, if any, of the alternative tax
consequences and
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holding periods described above would be adopted by the IRS or a court of law. Accordingly, U.S. Holders should consult their tax
advisors regarding the tax consequences of a cashless exercise.
Additional Considerations
Tax-Exempt Investors
Special considerations apply to U.S. persons that are pension plans and other investors that are subject to tax only on their
unrelated business taxable income. Such a tax-exempt investor’s income from an investment in our common shares or warrants generally
will not be treated as resulting in unrelated business taxable income under current law, so long as such investor’s acquisition of common
shares or warrants is not debt-financed. Tax-exempt investors should consult their own tax advisors regarding an investment in our
common shares or warrants.
Additional Tax on Passive Income
Certain individuals, estates and trusts whose income exceeds certain thresholds will generally be required to pay a 3.8% Medicare
surtax on the lesser of (1) the U.S. Holder’s “net investment income” for the relevant taxable year and (2) the excess of the U.S. Holder’s
modified gross income for the taxable year over a certain threshold (which, in the case of individuals, will generally be between
U.S.$125,000 and U.S.$250,000 depending on the individual’s circumstances). A U.S. Holder’s “net investment income” may generally
include, among other items, certain interest, dividends, gain, and other types of income from investments, minus the allowable deductions
that are properly allocable to that gross income or net gain. U.S. Holders are urged to consult with their own tax advisors regarding the
effect, if any, of this tax on their ownership and disposition of common shares or warrants.
Receipt of Foreign Currency
The amount of any distribution paid to a U.S. Holder in foreign currency, or on the sale, exchange or other taxable disposition of
common shares or warrants, generally will be equal to the U.S. dollar value of such foreign currency based on the exchange rate applicable
on the date of receipt (regardless of whether such foreign currency is converted into U.S. dollars at that time). A U.S. Holder will have a
basis in the foreign currency equal to its U.S. dollar value on the date of receipt. Any U.S. Holder who converts or otherwise disposes of
the foreign currency after the date of receipt may have a foreign currency exchange gain or loss that would be treated as ordinary income
or loss, and generally will be U.S. source income or loss for foreign tax credit purposes. Each U.S. Holder should consult its own U.S. tax
advisor regarding the U.S. federal income tax consequences of receiving, owning, and disposing of foreign currency.
Foreign Tax Credit
Subject to the PFIC rules discussed above, a U.S. Holder that pays (whether directly or through withholding) Canadian income tax
with respect to dividends paid on the common shares generally will be entitled, at the election of such U.S. Holder, to receive either a
deduction or a credit for such Canadian income tax paid. Generally, a credit will reduce a U.S. Holder’s U.S. federal income tax liability on
a dollar-for-dollar basis, whereas a deduction will reduce a U.S. Holder’s income subject to U.S. federal income tax. This election is made
on a year-by-year basis and generally applies to all foreign taxes paid (whether directly or through withholding) or accrued by a U.S.
Holder during a year.
Complex limitations apply to the foreign tax credit, including the general limitation that the credit cannot exceed the proportionate
share of a U.S. Holder’s U.S. federal income tax liability that such U.S. Holder’s “foreign source” taxable income bears to such U.S.
Holder’s worldwide taxable income. In applying this limitation, a U.S. Holder’s various items of income and deduction must be classified,
under complex rules, as either “foreign source” or “U.S. source.” Generally, dividends paid by a foreign corporation should be treated as
foreign source for this purpose, and gains recognized on the sale of stock of a foreign corporation by a U.S. Holder should generally be
treated as U.S. source for this purpose, except as otherwise provided in an applicable income tax treaty or if an election is properly made
under the Code. However, the amount of a distribution with respect to the common shares that is treated as a “dividend” may be lower for
U.S. federal income tax purposes than it is for Canadian federal income tax purposes, resulting in a reduced foreign tax credit allowance to
a U.S. Holder. In addition, this limitation
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is calculated separately with respect to specific categories of income. The foreign tax credit rules are complex, and each U.S. Holder should
consult its own U.S. tax advisor regarding the foreign tax credit rules.
Payments to Foreign Financial Institutions
The Hiring Incentives to Restore Employment Act of March 2010 (the “HIRE Act ”), including the Foreign Account Tax
Compliance Act (“ FATCA”) provisions promulgated thereunder, generally provides that a 30% withholding tax may be imposed on
payments of U.S. source income and proceeds from the sale of property that could give rise to U.S. source interest or dividends to certain
non-U.S. entities unless such entities enter into an agreement with the IRS to disclose the name, address and taxpayer identification number
of certain U.S. persons that own, directly or indirectly, interests in such entities, as well as certain other information relating to such
interests. U.S. Holders are encouraged to consult with their own tax advisors regarding the possible implications and obligations of
FATCA and the HIRE Act.
Information Reporting
In general, U.S. Holders of common shares are subject to certain information reporting under the Code relating to their purchase
and/or ownership of stock of a foreign corporation such as the Company. Failure to comply with these information reporting requirements
may result in substantial penalties.
For example, recently enacted legislation generally requires certain individuals who are U.S. Holders to file Form 8938 to report
the ownership of specified foreign financial assets if the total value of those assets exceeds an applicable threshold amount (subject to
certain exceptions). For these purposes, a specified foreign financial asset includes not only a financial account (as defined for these
purposes) maintained by a foreign financial institution, but also any stock or security issued by a non-U.S. person, any financial instrument
or contract held for investment that has an issuer or counterparty other than a U.S. person and any interest in a foreign entity, provided that
the asset is not held in an account maintained by a financial institution. The minimum applicable threshold amount is generally U.S.$50,000
in the aggregate, but this threshold amount varies depending on whether the individual lives in the U.S., is married, files a joint income tax
return with his or her spouse, etc. Certain domestic entities that are U.S. Holders may also be required to file Form 8938 in the near future.
U.S. Holders are urged to consult with their tax advisors regarding their reporting obligations, including the requirement to file IRS Form
8938.
In addition, in certain circumstances, a U.S. Holder of common shares who disposes of such common shares in a transaction
resulting in the recognition by such Holder of losses in excess of certain significant threshold amounts may be obligated to disclose its
participation in such transaction in accordance with the Treasury Regulations governing tax shelters and other potentially tax-motivated
transactions or tax shelter regulations. Potential purchasers of common shares should consult their tax advisors concerning any possible
disclosure obligation under the tax shelter rules with respect to the disposition of their common shares.
Backup Withholding
Generally, information reporting requirements will apply to distributions on our common shares or proceeds on the disposition of
our common shares or warrants paid within the U.S. (and, in certain cases, outside the U.S.) to U.S. Holders. Such payments will generally
be subject to backup withholding tax at the rate of 28% if: (a) a U.S. Holder fails to furnish such U.S. Holder’s correct U.S. taxpayer
identification number to the payor (generally on Form W-9), as required by the Code and Treasury Regulations, (b) the IRS notifies the
payor that the U.S. Holder’s taxpayer identification number is incorrect, (c) a U.S. Holder is notified by the IRS that it has previously failed
to properly report interest and dividend income, or (d) a U.S. Holder fails to certify, under penalty of perjury, that such U.S. Holder has
furnished its correct U.S. taxpayer identification number. However, certain exempt persons generally are excluded from these information
reporting and backup withholding rules.
Backup withholding is not an additional tax. Any amounts withheld under the U.S. backup withholding tax rules will be allowed
as a credit against a U.S. Holder’s U.S. federal income tax liability, if any, or will be refunded, if such U.S. Holder furnishes required
information to the IRS in a timely manner. Each U.S. Holder should consult its own tax advisor regarding the backup withholding rules.
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Canadian Federal Income Tax Considerations
Taxation
The following summary describes the principal Canadian federal income tax considerations generally applicable to a holder of the
Company’s common shares who, for purposes of the Income Tax Act (Canada) (the “ Canadian Tax Act”) and the Canada – United States
Income Tax Convention (the “Treaty”) and at all relevant times, is resident in the United States and was not and is not resident in Canada
nor deemed to be resident in Canada, deals at arm’s length and is not affiliated with the Company, holds the Company’s common shares as
capital property, does not use or hold and is not deemed to use or hold the Company’s common shares in or in the course of carrying on
business in Canada and who otherwise qualifies for the full benefit of the Treaty (a “United States Holder”). Special rules which are not
discussed in this summary may apply to a United States Holder that is a financial institution, as defined in the Canadian Tax Act, or an
insurer whom the Company’s common shares are designed as insurance property.
This following summary is based on the current provisions of the Treaty, the Canadian Tax Act and the regulations thereunder, all
specific proposals to amend the Canadian Tax Act and the regulations announced by the Minister of Finance (Canada) prior to the date
hereof and the Company’s understanding of the administrative practices published in writing by the Canada Revenue Agency prior to the
date hereof. This summary does not take into account or anticipate any other changes in the governing law, whether by judicial,
governmental or legislative decision or action, nor does it take into account the tax legislation or considerations of any province, territory or
non-Canadian (including U.S.) jurisdiction, which legislation or considerations may differ significantly from those described herein.
All amounts relevant in computing a United States Holder’s liability under the Canadian Tax Act are to be computed in Canadian
currency based on the relevant exchange rate applicable thereto.
This summary is of a general nature only and is not intended to be, and should not be interpreted as legal or tax advice to any
prospective purchaser or holder of the Company’s common shares and no representation with respect to the Canadian federal income tax
consequences to any such prospective purchaser is made. Accordingly, prospective purchasers and holders of the Company’s shares should
consult their own tax advisors with respect to their particular circumstances.
Dividends on the Company’s Common Shares
Generally, dividends paid or credited by Canadian corporations to non-resident shareholders are subject to a withholding tax of
25% of the gross amount of such dividends. Pursuant to the Treaty, the withholding tax rate on the gross amount of dividends paid or
credited to United States Holders is reduced to 15% or, in the case of a United States Holder that is a U.S. corporation that beneficially
owns at least 10% of the voting stock of the Canadian corporation paying the dividends, to 5% of the gross amount of such dividends.
Pursuant to the Treaty, certain tax-exempt entities that are United States Holders may be exempt from Canadian withholding
taxes, including any withholding tax levied in respect of dividends received on the Company’s common shares.
Disposition of the Company’s Common Shares
In general, a United States Holder will not be subject to Canadian income tax on capital gains arising on the disposition of the
Company’s common shares, unless such shares are “taxable Canadian property” within the meaning of the Canadian Tax Act. Generally,
the shares of a corporation resident in Canada will not be taxable Canadian property of a United States Holder at the time of disposition
unless at any time during the 60-month period immediately preceding the disposition, more than 50% of the value of the Company’s
common shares was derived directly or indirectly from properties that are “real or immovable properties”, “Canadian resource properties”,
or “timber resource properties”, within the meaning of the Canadian Tax Act. The value of the Company’s common shares is not now, and
is not expected to be in the future, derived more than 50% from any of these properties. Consequently, any gain realized by a United States
Holder upon the disposition of the Company’s common shares should be exempt from tax under the Canadian Tax Act.
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F.
Dividends and Paying Agents
Not Applicable.
G.
Statement by Experts
Not Applicable.
H.
Documents on Display
Copies of the documents referred to in this annual report may be inspected, during normal business hours, at the Company’s
headquarters located at 30 Worcester Road, Toronto, Ontario, M9W 5X2, Canada.
We are required to file reports and other information with the SEC under the U.S. Exchange Act. Reports and other information
filed by us with the SEC may be inspected and copied at the SEC’s public reference facilities located at 100 F Street, N.E. in Washington
D.C. The SEC also maintains a website at http://www.sec.gov that contains certain reports and other information that we file electronically
with the SEC. As a foreign private issuer, we are exempt from the rules under the U.S. Exchange Act prescribing the furnishing and content
of proxy statements and our officers, directors and principal shareholders are exempt from the reporting and short-swing profit recovery
provisions contained in Section 16 of the U.S. Exchange Act. Under the U.S. Exchange Act, as a foreign private issuer, we are not required
to publish financial statements as frequently or as promptly as United States companies.
I.
Subsidiary Information
See Item 4.C of this annual report.
Item 11.
Qualitative and Quantitative Disclosures about Market Risk
Interest rate and credit risk
Interest rate risk is the risk that the value of a financial instrument might be adversely affected by a change in interest rates. The
Company does not believe that the results of operations or cash flows would be affected to any significant degree by a sudden change in
market interest rates, relative to interest rates on cash and cash equivalents, due to related parties and capital lease obligations due to the
short-term nature of these balances.
Trade accounts receivable potentially subjects the Company to credit risk. The Company provides an allowance for doubtful
accounts equal to the estimated losses expected to be incurred in the collection of accounts receivable.
The following table sets forth details of the aged accounts receivable that are not overdue as well as an analysis of overdue
amounts and the related allowance for doubtful accounts:
Total accounts receivable
Less allowance for doubtful accounts
Total accounts receivable, net
Not past due
Past due for more than 31 days
but no more than 60 days
Past due for more than 91 days
but no more than 120 days
Total accounts receivable, net
November 30,
2014
$
November 30,
2013
$
1,011,133
-
1,011,133
1,475,745
-
1,475,745
982,313
1,473,097
5,950
2,648
22,870
1,011,133
-
1,475,745
Financial instruments that potentially subject the Company to concentration of credit risk consist principally of uncollateralized
accounts receivable. The Company’s maximum exposure to credit risk is equal to the
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potential amount of financial assets. For the years ended November 30, 2014 and November 30, 2013, Par accounted for substantially all
the revenue and all the accounts receivable of the Company.
The Company is also exposed to credit risk at period end from the carrying value of its cash. The Company manages this risk by
maintaining bank accounts with a Canadian Chartered Bank. The Company’s cash is not subject to any external restrictions.
Foreign exchange risk
The Company has balances in Canadian dollars that give rise to exposure to foreign exchange (“FX”) risk relating to the impact of
translating certain non-U.S. dollar balance sheet accounts as these statements are presented in U.S. dollars. A strengthening U.S. dollar will
lead to a FX loss while a weakening U.S. dollar will lead to a FX gain. For each Canadian dollar balance of $1.0 million, a +/- 10%
movement in the Canadian currency held by the Company versus the US dollar would affect the Company’s loss and other comprehensive
loss by $0.1 million.
Balances denominated in foreign currencies that are considered financial instruments are as follows:
FX rates used to translate to U.S.
Assets
Cash
Liabilities
Accounts payable
Employee cost payable
Capital lease
Due to related party
Net exposure
Liquidity risk
Canadian
1.1440
$
510,459
510,459
379,014
207,297
25,538
-
611,849
(101,390)
November 30, 2014
U.S
Canadian
November 30, 2013
U.S
$
1.0620
$
446,205
446,205
331,306
181,204
22,323
-
534,833
(88,628)
461,002
461,002
484,299
182,970
45,947
806,657
1,519,873
(1,058,871)
$
434,089
434,089
456,025
172,288
43,265
759,564
1,431,142
(997,053)
Liquidity risk is the risk that the Company will encounter difficulty raising liquid funds to meet commitments as they fall due. In
meeting its liquidity requirements, the Company closely monitors its forecasted cash requirements with expected cash drawdown.
The following are the contractual maturities of the undiscounted cash flows of financial liabilities as at November 30, 2014:
Less than
3 months
$
668,069
675,487
5,148
3 to 6
months
$
-
-
5,288
6 to 9
months
$
-
-
5,431
181,204
44,353
1,574,261
-
-
44,353 1,515,277
49,641 1,520,708
November 30, 2014
9 months Greater than
1 year
$
1 year
$
Total
$
-
-
5,581
-
-
5,581
-
-
42,160
668,069
675,487
63,608
181,204
-
- 1,603,983
42,160 3,192,351
Third parties
Accounts payable
Accrued liabilities
Capital lease (note 9)
Related parties
Employee costs payable (Note 8)
Convertible debenture (Note 7)
Limitations:
The above discussion includes only those exposures that existed as of November 30, 2013 and, as a result, does not consider
exposures or positions that could arise after that date. The Company’s ultimate realized gain or
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loss with respect to interest rate and exchange rate fluctuations would depend on the exposures that arise during the period and interest and
foreign exchange rates.
Item 12.
Description of Securities Other than Equity Securities.
A. Debt Securities
Not applicable.
B. Warrants and Rights
Not applicable.
C. Other Securities
Not applicable.
D. American Depositary Shares
None.
Item 13.
Defaults, Dividend Arrearages and Delinquencies
PART II.
There have been no material defaults in the payment of any principal or interest owing. Neither the Company nor its subsidiaries
has any preferred shares outstanding.
Item 14.
Material Modifications to the Rights of Security Holders and Use of Proceeds
There has been no material modification of the instruments defining the rights of holders of any class of registered securities.
There has been no withdrawal or substitution of assets securing any class of registered securities.
Item 15.
Controls and Procedures
Internal Control Over Financial Reporting
The management of our Company is responsible for establishing and maintaining adequate internal control over financial
reporting for the Company. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements in accordance with generally accepted accounting principles and
includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect
the transactions and dispositions of the Company’s assets, (2) provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with generally accepted accounting principles, and that the Company’s receipts
and expenditures are being made only in accordance with authorizations of the Company’s management and directors, and (3) provide
reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Company’s assets that
could have a material effect on the financial statements.
Management assessed the effectiveness of the Company’s internal control over financial reporting using the 1992 Internal
Control-Integrated Framework developed by the Committee of Sponsoring Organizations of the Treadway Commission.
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Based on this assessment, management concluded that the Company’s internal control over financial reporting was effective as of
November 30, 2014. Management has not identified any material weaknesses or changes in the Company’s internal control over financial
reporting as of November 30, 2014.
Changes In Internal Control Over Financial Reporting
There were no changes made to the Company’s internal control over financial reporting that have materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting. Specifically, there were no changes in accounting
functions, board or related committees and charters, or auditors; no functions, controls or financial reporting processes of any constituent
entities were adopted as Intellipharmaceutics’ functions, controls and financial processes; no other significant business processes were
implemented; and no consultants assisting management in the assessment and documentation of internal controls were engaged.
Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including the Chief Executive Officer and the Chief
Financial Officer, we have evaluated the effectiveness of our disclosure controls and procedures as at November 30, 2014. Disclosure
controls and procedures are designed to ensure that the information required to be disclosed by the Company in the reports it files or
submits under securities legislation is recorded, processed, summarized and reported on a timely basis and that such information is
accumulated and reported to management, including the Company’s Chief Executive Officer and Chief Financial Officer, as appropriate, to
allow required disclosures to be made in a timely fashion. Based on that evaluation, management has concluded that these disclosure
controls and procedures were effective as at November 30, 2014.
Attestation of Internal Control Over Financial Reporting
This annual report does not include an attestation report of our independent registered public accounting firm regarding internal
control over financial reporting for the Company. As the Company is a non-accelerated filer, management's report is not subject to
attestation by our independent registered public accounting firm pursuant to Section 404(c) of the Sarbanes-Oxley Act of 2002
Item 16A.
Audit Committee Financial Expert.
Our Audit Committee is comprised of Kenneth Keirstead, Bahadur Madhani and Dr. Eldon Smith, each of whom is considered
independent and financially literate (as such terms are defined under National Instrument 52-110 – Audit Committee). The members of the
Audit Committee have selected a Chair from amongst themselves, being Mr. Madhani.
Under the SEC rules implementing the Sarbanes-Oxley Act of 2002, Canadian issuers filing reports in the United States must
disclose whether their audit committees have at least one “audit committee financial expert”. Additionally, under NASDAQ Listing Rule
5605(c)(2)(A), NASDAQ requires that one member of the audit committee have “past employment experience in finance or accounting,
requisite professional certification in accounting, or any other comparable experience or background which results in the individual’s
financial sophistication, including being or having been a chief executive officer, chief financial officer, or other senior officer with
financial oversight responsibilities.” The Board has determined that Mr. Madhani qualifies as an Audit Committee financial expert under
the SEC rules and as financially sophisticated under the NASDAQ rules.
Item 16B.
Code of Ethics.
The Code of Business Conduct and Ethics (the “Code of Ethics”) has been implemented and it applies to all directors, officers,
employees of the Company and its subsidiaries. It may be viewed on our website at www.intellipharmaceutics.com. During the year ended
November 30, 2014, no waivers or requests for exemptions from the Code of Ethics were either requested or granted.
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Item 16C.
Principal Accountant Fees and Services.
Our auditor is Deloitte LLP (“Deloitte”), Independent Registered Public Accounting Firm, 5140 Yonge Street, Suite 1700,
Toronto, ON M2N 6L7. Deloitte is independent with respect to the Company within the meaning of the Rules of Professional Conduct of
the Institute of Chartered Accountants of Ontario and the rules and standards of the PCAOB and the securities laws and regulations
administered by the SEC.
The aggregate amounts billed by our auditors to us for the years ended November 30, 2014 and 2013 for audit fees, audit-related
fees, tax fees and all other fees are set forth below:
Audit Fees(1)
Audit-Related Fees(2)
Tax Fees(3)
Total Fees
Notes:
2014
C$362,566
50,290
27,298
C$440,154
2013
C$312,530
-
40,237
C$352,767
(1) Audit fees consist of fees related to the audit of the Company’s consolidated financial statements and reviews of quarterly interim
financial statements, and Form 20-F, Form F-3, base shelf prospectus activities and prospectus supplement activities.
(2) Audit-related fees consist of consultation on accounting and disclosure matters.
(3) Tax fees consist of fees for tax consultation, tax advice and tax compliance services for the Company and its subsidiaries.
The Company’s related party pre-approval policies and procedures are described in Item 6.C.
Under applicable Canadian securities regulations, the Company is required to disclose whether its Audit Committee has adopted
specific policies and procedures for the engagement of non-audit services and to prepare a summary of these policies and procedures. The
Audit Committee’s responsibility is to approve all audit engagement fees and terms as well as reviewing policies for the provision of non-
audit services by the external auditors and, when required, the framework for pre-approval of such services. The Audit Committee
delegates to its Chairman the pre-approval of such non-audit fees. For each of the years ended November 30, 2014 and 2013, all of the non-
audit services provided by the Company’s external auditor were approved by the Chairman of the Audit Committee.
Item 16D.
Exemptions from the Listing Standards for Audit Committees.
Not Applicable.
Item 16E.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers.
Neither the Company nor, to our knowledge, any affiliated purchaser has made any purchases of our registered shares during the
last financial year although shares were received by affiliated purchasers in connection with the IPC Arrangement Agreement (see Item
4.A).
Item 16F.
Change in Registrant’s Certifying Accountant.
None.
Item 16G.
Corporate Governance.
The Company is the successor issuer to Vasogen Inc. for reporting purposes under the U.S. Exchange Act. Our common shares are
currently listed on the TSX and quoted for trading on NASDAQ under the symbols “I” and “IPCI”, respectively. Our shares began trading
on October 22, 2009, when the IPC Arrangement Agreement with Vasogen was completed.
-91-
Variations from Certain NASDAQ Rules
NASDAQ listing rules permit the Company to follow certain home country practices in lieu of compliance with certain NASDAQ
corporate governance rules. Set forth below are the requirements of NASDAQ’s Rule 5600 Series that the Company does not follow and
the home country practices that it follows in lieu thereof and other differences from domestic U.S. companies that apply to us under
NASDAQ’s corporate governance rules.
Shareholder Approval in Connection with Certain Transactions: NASDAQ’s Rule 5635 requires each issuer to obtain shareholder
approval prior to certain dilutive events, including: (i) a transaction other than a public offering involving the sale under certain
circumstances of 20% or more of the issuer’s common shares outstanding prior to the transaction at a price less than the greater of book
value or market value, (ii) the acquisition of the stock or assets of another company; (iii) equity-based compensation of officers, directors,
employees or consultants and (iv) a change of control. Under the exemption available to foreign private issuers under NASDAQ Rule
5615(a)(3), the Company does not follow NASDAQ Rule 5635. Instead, and in accordance with the NASDAQ exemption, the Company
complies with applicable TSX rules and applicable Canadian corporate and securities regulatory requirements.
Independence of the Majority of the Board of Directors; Independent Director Oversight of Executive Compensation and Board
Nominations: NASDAQ’s Rule 5605(b)(1) requires that the Board of Directors be comprised of a majority of independent directors, as
defined in Rule 5605(a)(2). NASDAQ’s Rule 5605(b)(2) requires the independent members of the Board to regularly hold executive
sessions where only those directors are present. Moreover, NASDAQ’s Rule 5605(d) requires independent director oversight of executive
officer compensation arrangements by approval of such compensation by a majority of the independent directors or by a compensation
committee comprised solely of independent directors, and Rule 5605(e) requires similar oversight with respect to the process of selecting
nominees to the Board. Under the exemption available to foreign private issuers under Rule 5615(a)(3), the Company does not follow
NASDAQ Rules 5605(b)(1), 5605(d) or 5605(e). Instead, and in accordance with the NASDAQ exemption, the Company complies with
the applicable TSX rules and applicable Canadian corporate and securities regulatory requirements.
Disclosure of Waivers of Code of Business Conduct and Ethics: Domestic U.S. NASDAQ listed companies are required under
NASDAQ Rule 5610 to disclose any waivers of their codes of conduct for directors or executive officers in a Form 8-K within four
business days. As a foreign private issuer we are required to disclose any such waivers either in a Form 6-K or in the Company’s next Form
20-F or 40- F.
Item 16H. Mine Safety Disclosure.
Not applicable.
Item 17.
Financial Statements.
See Item 18 below.
Item 18.
Financial Statements.
PART III.
-92-
Consolidated financial statements of
Intellipharmaceutics
International Inc.
November 30, 2014, 2013 and 2012
Intellipharmaceutics International Inc.
November 30, 2014, 2013 and 2012
Table of contents
Report of Independent Registered Public Accounting Firm
Consolidated balance sheets
Consolidated statements of operations and comprehensive loss
Consolidated statements of shareholders’ equity (deficiency)
Consolidated statements of cash flows
Notes to the consolidated financial statements
1
2
3
4
5
6-32
Deloitte LLP
5140 Yonge Street
Suite 1700
Toronto ON M2N 6L7
Canada
Tel: 416-601-6150
Fax: 416-601-6151
www.deloitte.ca
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of
Intellipharmaceutics International Inc.
We have audited the accompanying consolidated financial statements of Intellipharmaceutics International Inc. and subsidiaries (the
“Company”), which comprise the consolidated balance sheets as at November 30, 2014 and November 30, 2013, and the consolidated
statements of operations and comprehensive loss, shareholders’ equity (deficiency), and cash flows for each of the years in the three-year
period ended November 30, 2014, and a summary of significant accounting policies and other explanatory information.
Management’s Responsibility for the Consolidated Financial Statements
Management is responsible for the preparation and fair presentation of these consolidated financial statements in accordance with
accounting principles generally accepted in the United States of America, and for such internal control as management determines is
necessary to enable the preparation of consolidated financial statements that are free from material misstatement, whether due to fraud or
error.
Auditor’s Responsibility
Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We conducted our audits in
accordance with Canadian generally accepted auditing standards and the standards of the Public Company Accounting Oversight Board
(United States). Those standards require that we comply with ethical requirements and plan and perform the audit to obtain reasonable
assurance about whether the consolidated financial statements are free from material misstatement. We were not engaged to perform an
audit of the Company’s internal control over financial reporting. Our audits included consideration of internal control over financial
reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the consolidated financial
statements. The procedures selected depend on the auditor’s judgment, including the assessment of the risks of material misstatement of
the consolidated financial statements, whether due to fraud or error. An audit also includes evaluating the appropriateness of accounting
policies used and the reasonableness of accounting estimates made by management, as well as evaluating the overall presentation of the
consolidated financial statements.
We believe that the audit evidence we have obtained in our audits is sufficient and appropriate to provide a basis for our audit opinion.
Opinion
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of Intellipharmaceutics
International Inc. as at November 30, 2014, November 30, 2013, and its financial performance and its cash flows for each of the years in
the three-year period ended November 30, 2014 in accordance with accounting principles generally accepted in the United States of
America.
Emphasis of Matter
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in
Note 1 to the financial statements, the Company’s recurring losses from operations and the accumulated deficit cast substantial doubt about
its ability to continue as a going concern. Management’s plans concerning these matters are also discussed in Note 1 to the financial
statements. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
/s/ Deloitte LLP
Chartered Professional Accountants, Chartered Accountants
Licensed Public Accountants
February 23, 2015
Toronto, Canada
Intellipharmaceutics International Inc.
Consolidated balance sheets
As at November 30, 2014 and 2013
(Stated in U.S. dollars)
Assets
Current
Cash
Accounts receivable, net (Note 4)
Investment tax credits
Prepaid expenses, sundry and other assets
Deferred offering costs (Note 10)
Property and equipment, net (Note 5)
Liabilities
Current
Accounts payable
Accrued liabilities (Note 6)
Employee costs payable (Note 8)
Current portion of capital lease obligations (Note 9)
Due to related parties (Note 7)
Convertible debenture (Note 7)
Capital lease obligations (Note 9)
Warrant liabilities (Note 14)
Shareholders' equity (deficiency)
Capital stock (Notes 10 and 11)
Authorized
Unlimited common shares without par value
Unlimited preference shares
Issued and outstanding 23,456,611 common shares (2013 - 21,430,611)
Additional paid-in capital
Accumulated other comprehensive income
Accumulated deficit
Contingencies (Note 16)
On behalf of the Board:
2014
$
2013
$
4,233,975
1,011,133
324,986
414,663
5,984,757
271,381
1,618,897
7,875,035
668,069
675,487
181,204
21,449
-
1,377,302
2,923,511
42,160
-
2,965,671
760,586
1,475,745
179,551
312,533
2,728,415
419,777
1,231,309
4,379,501
810,381
669,321
508,616
43,264
759,564
2,105,406
4,896,552
-
5,438,022
10,334,574
18,941,067
31,119,930
284,421
(45,436,054)
4,909,364
11,721,152
23,619,055
284,421
(41,579,701)
(5,955,073)
7,875,035
4,379,501
/s/ Dr. Isa Odidi
Dr. Isa Odidi, Chairman of the Board
/s/ Bahadur Madhani
Bahadur Madhani, Director
See accompanying notes to consolidated financial statements
Page 2
Intellipharmaceutics International Inc.
Consolidated statements of operations and comprehensive loss
for the years ended November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
Revenues
Licensing (Note 3)
Milestone
Research and development
Other incidental services
Expenses
Research and development
Selling, general and administrative
Depreciation (Note 5)
Write-down on long lived assets (Note 5)
Loss from operations
Fair value adjustment of derivative liabilities (Note 7 and 14)
Financing expense (Note 10)
Net foreign exchange gain (loss)
Interest income
Interest expense
Net loss
Other comprehensive income (loss)
Foreign exchange translation adjustment
Comprehensive loss
Loss per common share, basic and diluted
Weighted average number of common shares outstanding, basic and
2014
$
8,415,540
354,153
-
-
8,769,693
8,020,201
3,900,803
381,385
-
12,302,389
(3,532,696)
-
-
10,896
4,898
(339,451)
(3,856,353)
2013
$
1,481,719
43,209
-
2,546
1,527,474
5,076,236
2,873,091
396,814
-
8,346,141
(6,818,667)
(3,889,683)
(115,056)
(359,554)
2,839
(314,896)
(11,495,017)
-
(3,856,353)
(0.17)
524,431
(10,970,586)
(0.58)
2012
$
-
-
107,091
-
107,091
5,992,417
3,672,313
452,303
107,123
10,224,156
(10,117,065)
3,841,233
-
181,682
20,691
(63,406)
(6,136,865)
(124,975)
(6,261,840)
(0.36)
diluted
23,050,618
19,671,093
17,258,686
See accompanying notes to consolidated financial statements
Page 3
Intellipharmaceutics International Inc.
Consolidated statements of shareholders' equity (deficiency)
for the years ended November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
Balance, November 30, 2011
15,908,444
Number
Capital
stock
amount
$
Additional
paid-in
capital
$
902,276 20,067,548
Accumulated
other
comprehensive
Accumulated
(loss) income
$
(115,035)
deficit
$
(23,947,819)
Total
shareholders'
equity
(deficiency)
$
(3,093,030)
1,818,182 5,000,000
-
(779,271)
-
-
-
- 2,251,325
-
-
-
72,520
-
36,727
180,315 1,005,692
-
-
-
-
1,998,493 5,226,421 2,360,572
-
-
(4)
-
-
-
-
-
-
-
-
-
-
-
-
-
-
5,000,000
(779,271)
2,251,325
72,520
36,727
-
1,005,692
(124,975)
-
-
(124,975)
-
(6,136,865)
-
(6,136,865)
(124,975)
(6,136,865)
-
1,325,153
17,906,937 6,128,697 22,428,120
-
3,315,000 5,460,892
-
(857,278)
-
- 1,017,908
-
(240,010)
-
-
-
(30,084,684)
-
-
-
(1,767,877)
5,460,892
(857,278)
1,017,908
-
-
-
135,974
-
39,547
3,500
8,459
(2,494)
205,175
980,382
-
-
-
-
3,523,674 5,592,455 1,190,935
-
-
(1)
-
-
-
-
-
-
-
-
-
-
135,974
39,547
5,965
-
980,382
524,431
-
-
524,431
-
(11,495,017)
-
(11,495,017)
524,431
(11,495,017)
-
(4,187,196)
21,430,611 11,721,152 23,619,055
- 5,438,022
-
284,421
-
(41,579,701)
-
(5,955,073)
5,438,022
Issuance of common shares (Note 10)
Share issuance cost (Note 10)
Stock options to employees (Note 11)
Stock options to non-management board
members (Note 11)
DSU's to non-management board members
(Note 12)
Issuance of shares on exercise of cashless
warrants (Note 14)
Other comprehensive loss (net of tax -
$Nil)
Net loss
Cancellation on shares exchanged
Balance, November 30, 2012
Issuance of common shares (Note 10)
Share issuance cost (Note 10)
Stock options to employees (Note 11)
Stock options to non-management board
members (Note 11)
DSU's to non-management board members
(Note 12)
Shares issued for options exercised (Note
11)
Issuance of shares on exercise of warrants
(Note 14)
Other comprehensive gain (net of tax -
$Nil)
Net loss
Cancellation on shares exchanged
Balance, November 30, 2013
Reclass of warrant liabilities (Note 14)
Reclass of conversion option in convertible
debenture (Note 7)
DSU's to non-management board members
(Note 12)
Stock options to employees (Note 11)
Shares issued for options exercised (Note
-
-
-
-
728,950
-
20,807
- 1,748,607
11)
48,000
168,693
(51,709)
Proceeds from at-the-market financing
(Note 10)
Share issuance cost (Note 10)
Issuance of shares on exercise of warrants
(Note 14)
Adjustment of conversion option in
convertible debenture (Note 7)
Net loss
1,689,500 6,571,673
(811,887)
-
-
-
288,500 1,291,436
(510,216)
126,414
-
2,026,000 7,219,915 7,500,875
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
728,950
20,807
1,748,607
116,984
6,571,673
(811,887)
781,220
-
(3,856,353)
(3,856,353)
126,414
(3,856,353)
10,864,437
Balance, November 30, 2014
23,456,611 18,941,067 31,119,930
284,421
(45,436,054)
4,909,364
See accompanying consolidated financial statements
Page 4
Intellipharmaceutics International Inc.
Consolidated statements of cash flows
for the years ended November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
Net loss
Items not affecting cash
Depreciation (Note 5)
Stock-based compensation (Note 11)
Deferred share units (Note 12)
Fair value adjustment of derivative liabilities (Note 7 and 14)
Write-down on long lived assets (Note 5)
Accreted interest (Note 7)
Unrealized foreign exchange loss (gain)
Change in non-cash operating assets & liabilities
Accounts receivable
Investment tax credits
Prepaid expenses, sundry and other assets
Accounts payable and accrued liabilities
Deferred revenue
Cash flows used in operating activities
Financing activities
Repayment of related party loans (Note 7)
Repayment of capital lease obligations
Issuance of shares on exercise of stock options (Note 11)
Issuance of common shares on at-the-market financing, gross (Note 10)
Proceeds from issuance of shares and warrants, gross (Note 10)
Proceeds from issuance of shares on exercise of warrants (Note 14)
Proceeds from convertible debenture (Note 7)
Proceeds from issuance of shares, gross (Note 10)
Share issuance cost (Note 10)
Cash flows provided from financing activities
2014
$
2013
$
2012
$
(3,856,353)
(11,495,017)
(6,136,865)
381,385
1,748,607
20,807
-
-
127,261
3,057
464,611
(145,436)
(102,130)
(356,722)
-
(1,714,913)
(739,208)
(53,557)
116,984
6,571,673
-
781,220
-
-
(719,837)
5,957,275
396,814
1,153,882
39,547
3,889,683
-
96,556
306,625
(1,472,966)
106,744
(181,402)
232,738
-
(6,926,796)
-
(49,989)
5,965
-
6,196,800
511,743
1,500,000
-
(836,099)
7,328,420
452,303
2,323,845
36,727
(3,841,233)
107,123
-
(145,724)
605
96,264
(10,206)
(430,109)
(107,091)
(7,654,361)
-
(44,364)
-
-
-
187,500
-
5,000,000
(779,271)
4,363,865
Investing activity
Purchase of property and equipment
(768,973)
(122,017)
(1,036,092)
Cash flows used in investing activities
(768,973)
(122,017)
(1,036,092)
Effect of foreign exchange (gain) loss on cash held in foreign currency
-
(16,037)
6,516
Increase (decrease) in cash and cash equivalents
Cash and cash equivalents, beginning of year
3,473,389
760,586
263,570
497,016
(4,320,072)
4,817,088
Cash and cash equivalents, end of year
4,233,975
760,586
497,016
Supplemental cash flow information
Interest paid
Taxes paid
See accompanying consolidated financial statements
213,637
-
176,311
-
39,173
-
Page 5
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
1.
Nature of operations
Intellipharmaceutics International Inc. (“IPC” or the “Company”) is a pharmaceutical company specializing in the research,
development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs.
On October 22, 2009, IntelliPharmaCeutics Ltd. (“IPC Ltd. “) and Vasogen Inc. (“Vasogen”) completed a court approved plan of
arrangement and merger (the “IPC Arrangement Agreement”), resulting in the formation of the Company, which is incorporated
under the laws of Canada. The Company’s common shares are traded on the Toronto Stock Exchange and NASDAQ.
The Company earns revenues from development contracts which provide upfront fees, milestone payments, reimbursement of certain
expenditures and licensing income upon commercialization of its products. In November 2013, U.S. Food and Drug Administration
(“FDA”) granted the Company final approval to market the Company’s first product, the 15 mg and 30 mg strengths of our generic
Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules.
Going concern
The consolidated financial statements are prepared on a going concern basis, which assumes that the Company will be able to meet its
obligations and continue its operations for the next fiscal year. The Company has incurred losses from operations since inception and
has reported losses of $3,856,353 for the year ended November 30, 2014 (November 30, 2013 - $11,495,017), and has an
accumulated deficit of $45,436,054 as at November 30, 2014 (November 30, 2013 - $41,579,701). The Company has funded its
research and development activities principally through the issuance of securities, loans from related parties, funds from the IPC
Arrangement Agreement and funds received under development agreements. There is no certainty that such funding will be available
going forward. In the event that the Company does not obtain sufficient additional capital, casts substantial doubt about its ability to
continue as a going concern and realize its assets and pay its liabilities as they become due.
In order for the Company to continue as a going concern and fund any significant expansion of its operation or R&D activities which
are at higher than currently projected levels, the Company will likely require significant additional capital. Although there can be no
assurances, such capital may come from proceeds of the Company’s at-the-market offering program, from the sales of its generic
Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules, and from potential partnering opportunities. Other
potential sources of capital may include payments from licensing agreements, cost savings associated with managing operating
expense levels, other equity and/or debt financings, and/or new strategic partnership agreements which fund some or all costs of
product development, although there can be no assurance that the Company will be able to obtain any such capital on terms or in
amounts sufficient to meet its needs or at all. The Company’s ultimate success will depend on whether its product candidates receive
the approval of the FDA or other applicable regulatory agencies and it is able to successfully market approved products. The
Company cannot be certain that it will be able to receive FDA approval for any of its current or future product candidates, or that it
will reach the level of sales and revenues necessary to achieve and sustain profitability.
The availability of equity or debt financing will be affected by, among other things, the results of its research and development, the
Company’s ability to obtain regulatory approvals, the market acceptance of its products, the state of the capital markets generally,
strategic alliance agreements, and other relevant commercial considerations. In addition, if the Company raises additional funds by
issuing equity securities, its then existing security holders will likely experience dilution, and the incurring of indebtedness would
result in increased debt service obligations and could require the Company to agree to operating and financial covenants that would
restrict its operations. Any failure on its part to raise additional funds on terms favorable to the Company or at all, may require the
Company to significantly change or curtail its current or planned operations in order to conserve cash until such time, if ever, that
sufficient proceeds from operations are generated, and could result in the Company not taking advantage of business opportunities, in
the termination or delay of clinical trials or the Company not taking any necessary actions required by the FDA for one or more of the
Company’s product candidates, in curtailment of the Company’s product development programs designed to identify new product
candidates, in the sale or assignment of rights to its technologies, products or product candidates, and/or its inability to file
abbreviated new drug applications (“ANDAs”) or New Drug Applications (“NDAs”) at all or in time to competitively market its
products or product candidates.
Page 6
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
1.
Nature of operations (Continued)
Going concern (continued)
The consolidated financial statements do not include any adjustments that might result from the outcome of uncertainties described
above. If the going concern assumption was not appropriate for these financial statements, then adjustments would be necessary to
the carrying values of assets and liabilities, the reported expenses and the balance sheet classifications used. Such adjustments could
be material.
2.
Basis of presentation
(a) Basis of consolidation
These consolidated financial statements include the accounts of the Company and its wholly owned operating subsidiaries, IPC
Ltd., Intellipharmaceutics Corp. (“IPC Corp”), and Vasogen Corp. These consolidated financial statements also include the
results of Vasogen Ireland Ltd. up to June 27, 2012, the date of its dissolution.
All inter-company accounts and transactions have been eliminated on consolidation.
(b) Use of estimates
The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the
United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenue and expenses during the year. Actual results could differ from those estimates.
Areas where significant judgment is involved in making estimates are: the determination of the functional currency; the fair
values of financial assets and liabilities; the determination of units of accounting for revenue recognition; the accrual of
licensing and milestone revenue; and forecasting future cash flows for assessing the going concern assumption.
3.
Significant accounting policies
(a) Cash and cash equivalents
The Company considers all highly liquid securities with an original maturity of three months or less to be cash equivalents. Cash
equivalent balances consist of bankers’ acceptances and bank accounts with variable, market rates of interest.
The financial risks associated with these instruments are minimal and the Company has not experienced any losses from
investments in these securities. The carrying amount of cash and cash equivalents approximates its fair value due to its short-
term nature.
(b) Accounts receivable
The Company reviews its sales and accounts receivable aging and determines whether an allowance for doubtful accounts is
required.
(c) Financial instruments
The Company evaluates all of its financial instruments to determine if such instruments are derivatives or contain features that
qualify as embedded derivatives. For derivative financial instruments that are classified as liabilities, the derivative instrument is
initially recorded at its fair value using the appropriate valuation methodology and is then re-valued at each reporting date, with
changes in the fair value reported in the consolidated statements of operations and comprehensive loss.
Page 7
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
3.
Significant accounting policies (continued)
(d)
Investment tax credits
The investment tax credits (“ITC") receivable are amounts considered recoverable from the Canadian federal and provincial
governments under the Scientific Research & Experimental Development (“SR&ED”) incentive program. The amounts claimed
under the program represent the amounts based on management estimates of eligible research and development costs incurred
during the year. Realization is subject to government approval. Any adjustment to the amounts claimed will be recognized in the
year in which the adjustment occurs. Refundable ITCs claimed relating to capital expenditures are credited to property and
equipment. Refundable ITCs claimed relating to current expenditures are netted against research and development expenditures.
(e) Property and equipment
Property and equipment are recorded at cost. Equipment acquired under capital leases are recorded net of imputed interest, based
upon the net present value of future payments. Assets under capital leases are pledged as collateral for the related lease
obligation. Repairs and maintenance expenditures are charged to operations; major betterments and replacements are capitalized.
Depreciation bases and rates are as follows:
Assets
Basis
Rate
Computer equipment
Computer software
Furniture and fixtures
Laboratory equipment
Leasehold improvements
Declining balance
Declining balance
Declining balance
Declining balance
Straight line
30%
50%
20%
20%
Over term of lease
Leasehold improvements and assets acquired under capital leases are depreciated over the term of their useful lives or the lease
period, whichever is shorter. The charge to operations resulting from depreciation of assets acquired under capital leases is
included with depreciation expense.
(f)
Impairment of long-lived assets
Long-lived assets are reviewed for impairment when events or circumstances indicate that the carrying value of an asset may not
be recoverable. For assets that are to be held and used, impairment is recognized when the sum of estimated undiscounted cash
flows associated with the asset or group of assets is less than its carrying value. If impairment exists, an adjustment is made to
write the asset down to its fair value, and a loss is recorded as the difference between the carrying value and fair value.
(g) Warrants
The Company issued warrants as described in Notes 10 and 14. In the prior year the warrants were presented as a liability
because they did not meet the criteria of Accounting Standard Codification (“ASC”) topic 480 Distinguishing Liabilities from
Equity for equity classification. Subsequent changes in the fair value of the warrants were recorded in the consolidated
statements of operations and comprehensive loss. As discussed in Note 3(m) the Company changed its functional currency
effective December 1, 2013 such that these warrants meet the criteria for prospective equity classification in ASC 480, and the
U.S. dollar translated amount of the warrant liability at December 1, 2013 became the amount reclassified to equity.
Page 8
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
3.
Significant accounting policies (continued)
(h) Convertible debenture
The Company issued an unsecured convertible debenture in the principal amount of $1.5 million (the “Debenture”) as described
in Note 7. At issuance the conversion option was bifurcated from its host contract and the fair value of the conversion option
was characterized as an embedded derivative upon issuance as it met the criteria of ASC Topic 815 Derivatives and Hedging.
Subsequent changes in the fair value of the embedded derivative were recorded in the consolidated statements of operations and
comprehensive loss. The proceeds received from the Debenture less the initial amount allocated to the embedded derivative
were allocated to the liability and were accreted over the life of the Debenture using the imputed rate of interest. As discussed in
Note 3(m) the Company changed its functional currency effective December 1, 2013 such that the conversion option no longer
meets the criteria for bifurcation and was prospectively reclassified to shareholders equity under ASC Topic 815 at the U.S.
dollar translated amount at December 1, 2013.
(i) Revenue recognition
The Company accounts for revenue in accordance with the provision of ASC topic 605 Revenue Recognition. The Company
earns revenue from non-refundable upfront fees, milestone payments upon achievement of specified research or development,
exclusivity milestone payments and licensing payments on sales of resulting products and other incidental services. Revenue is
realized or realizable and earned when persuasive evidence of an arrangement exists, delivery has occurred or services have been
rendered, the price to the customer is fixed or determinable, and collectability is reasonably assured. From time to time, the
Company enters into transactions that represent multiple-element arrangements. Management evaluates arrangements with
multiple deliverables to determine whether the deliverables represent one or more units of accounting for the purpose of revenue
recognition.
A delivered item is considered a separate unit of accounting if the delivered item has stand-alone value to the customer, the fair
value of any undelivered items can be reliably determined, and the delivery of undelivered items is probable and substantially in
the Company's control.
The relevant revenue recognition accounting policy is applied to each separate unit of accounting.
Licensing
The Company recognizes revenue from the licensing of the Company's drug delivery technologies, products and product
candidates. Licensing revenue is recognized as earned in accordance with the contract terms when the amounts can be reasonably
estimated and collectability is reasonably assured.
The Company has a license and commercialization agreement with Par Pharmaceutical Inc. (“Par”). Under the exclusive
territorial license rights granted to Par, the agreement requires that Par manufacture, promote, market, sell and distribute the
product. Licensing revenue amounts receivable by the Company under this agreement are calculated and reported to the
Company by Par, with such amounts generally based upon net product sales and net profit which include estimates for
chargebacks, rebates, product returns, and other adjustments. Licensing revenue payments received by the Company from Par
under this agreement are not subject to deductions for chargebacks, rebates, product returns, and other pricing adjustments. Based
on this arrangement and the guidance per ASC topic 605, the Company records licensing revenue as earned in the consolidated
statements of operations and comprehensive loss.
Milestones
The milestone method recognizes revenue on substantive milestone payments in the period the milestone is achieved. Milestones
are considered substantive if all of the following conditions are met: (i) the milestone is commensurate with either the vendor’s
performance to achieve the milestone or the enhancement of the value of the delivered item or items as a result of a specific
outcome resulting from the vendor’s performance to achieve the milestone; (ii) the milestone relates solely to past performance;
and (iii) the milestone is reasonable relative to all of the deliverables and payment terms within the arrangement. Non-substantive
milestone payments that might be paid to the Company based on the passage of time or as a result of a partner’s performance are
allocated to the units of accounting within the arrangement; they are recognized as revenue in a manner similar to those units of
accounting. In connection with the license and commercialization agreement with Par, for each day up to a maximum of 180 days
from the date of launch if the Company’s product is the only generic in the market or if there is only one generic competitor, a
milestone payment is earned. The Company recognized revenue of $354,153 (2013 - $43,209; 2012 – $Nil) upon achievement of
the milestone.
Page 9
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
3.
Significant accounting policies (continued)
(i) Revenue recognition (continued)
Research and development
Under arrangements where the license fees and research and development activities can be accounted for as a separate unit of
accounting, non-refundable upfront license fees are deferred and recognized as revenue on a straight-line basis over the expected
term of the Company's continued involvement in the research and development process.
Deferred revenue represents the funds received from clients, for which the revenues have not yet been earned, as the milestones
have not been achieved, or in the case of upfront fees for drug development, where the work remains to be completed.
Other incidental services
Incidental services which we may provide from time to time include, consulting advice provided to other organizations regarding
FDA standards. Revenue is earned and realized when all of the following conditions are met: (i) there is persuasive evidence of
an arrangement; (ii) service has been rendered; (iii) the sales price is fixed or determinable; and (iv) collectability is reasonably
assured.
(j) Research and development costs
Research and development costs related to continued research and development programs are expensed as incurred in
accordance with ASC topic 730. However, materials and equipment are capitalized and amortized over their useful lives if they
have alternative future uses.
(k)
Income taxes
The Company uses the liability method of accounting for income taxes. Under the liability method, deferred tax assets and
liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying
amounts of existing assets and liabilities and their respective tax bases and for losses and tax credit carry forwards. Significant
judgment is required in determining whether deferred tax assets will be realized in full or in part. Deferred tax assets and
liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary
differences are expected to be recovered or settled.
The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the year that includes the date
of enactments. A valuation allowance is provided for the portion of deferred tax assets that is more likely than not to remain
unrealized.
The Company accounts in accordance with ASC topic 740-10. This ASC topic requires that uncertain tax positions are evaluated
in a two-step process, whereby (i) the Company determines whether it is more likely than not that the tax positions will be
sustained based on the technical merits of the position and (ii) those tax positions that meet the more likely than not recognition
threshold, the Company would recognize the largest amount of tax benefit that is greater than 50% likely of being realized upon
ultimate settlement with the related tax authority. Changes in recognition or measurement are reflected in the period in which the
change in judgment occurs. The cumulative effects of the application of the provisions of ASC topic 740-10 are described in
Note 15.
The Company records any interest related to income taxes in interest expense and penalties in selling, general and administrative
expense.
Page 10
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
3.
Significant accounting policies (continued)
(l)
Share issue costs
Share issue costs are recorded as a reduction of the proceeds from the issuance of capital stock.
(m) Translation of foreign currencies
Previously, operations of the Company were comprised of only research and development activities conducted in Canada. The
Company generated no cash from operations, though funding for the operations (as in previous years) was primarily through
U.S. dollar equity financings. The functional currency was assessed to be Canadian dollars. By obtaining the final approval of
the Company’s generic Focalin XR® (dexmethylphenidate hydrochloride extended-release) capsules for the 15 and 30 mg
strengths with Par in November 2013, the Company generated and collected U.S. dollar revenues in the year ended November
30, 2014 which represents a significant and material change in economic facts and circumstances. Management had assessed the
functional currency for the fiscal year commencing December 1, 2013 and concluded that the Company and its wholly owned
operating subsidiaries should be measured using the U.S. dollar as the functional currency. Effective December 1, 2013, the
change in functional currency was applied on a prospective basis. The U.S. dollar translated amounts of nonmonetary assets and
liabilities at December 1, 2013 became the historical accounting basis for those assets and liabilities at December 1, 2013. The
impact of the change in functional currency on the measurement and reporting of warrants and the Debenture is discussed in
Note 3(g) and 3(h) above. The change in functional currency will result in no change in cumulative translation adjustment going
forward as the Company and its wholly owned operating subsidiaries have U.S. dollar functional currencies.
In respect of other transactions denominated in currencies other than the Company and its wholly owned operating subsidiaries’
functional currencies, the monetary assets and liabilities are translated at the period end rates. Revenue and expenses are
translated at rates of exchange prevailing on the transaction dates. All of the exchange gains or losses resulting from these other
transactions are recognized in the consolidated statements of operations and comprehensive loss.
The Company’s reporting currency in the year ended November 30, 2014, 2013 and 2012 was the U.S. dollar.
(n) Stock-based compensation
The Company has a stock-based compensation plan which authorizes the granting of various equity-based incentives including
stock options and restricted share units (“RSU”s). The Company calculates stock-based compensation using the fair value
method, under which the fair value of the options at the grant date is calculated using the Black-Scholes Option Pricing Model,
and subsequently expensed over the expected life of the option. The provisions of the Company's stock-based compensation
plans do not require the Company to settle any options by transferring cash or other assets, and therefore the Company classifies
the awards as equity.
Stock-based compensation expense recognized during the period is based on the value of stock-based payment awards that are
ultimately expected to vest. The Company estimates forfeitures at the time of grant and revised, if necessary, in subsequent
periods if actual forfeitures differ from those estimates. The stock-based compensation expense is recorded in the consolidated
statements of operations and comprehensive loss under research and development expense and under selling, general and
administration expense. Note 11 provides supplemental disclosure of the Company's stock options.
(o) Deferred Share Units
Deferred Share Units (“DSU”s) are valued based on the trading price of the Company’s common shares on the Toronto Stock
Exchange. The Company records the value of the DSU’s owing to non-management board members in the consolidated
statement of equity (deficiency).
Page 11
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
3.
Significant accounting policies (continued)
(p) Loss per share
Basic loss per share (“EPS”) is computed by dividing the loss attributable to common shareholders by the weighted average
number of common shares outstanding. Diluted EPS reflects the potential dilution that could occur from common shares
issuable through the exercise or conversion of stock options, restricted stock awards, warrants and convertible securities. In
certain circumstances, the conversion of options, warrants and convertible securities are excluded from diluted EPS if the effect
of such inclusion would be anti-dilutive.
The dilutive effect of stock options is determined using the treasury stock method. Stock options and warrants to purchase
7,149,283, 7,034,647 and 7,830,059 common shares of the Company during fiscal 2014, 2013, and 2012, respectively, were not
included in the computation of diluted EPS because the Company has incurred a loss for the years ended November 30, 2014,
2013 and 2012 as the effect would be anti-dilutive.
(q) Comprehensive loss
The Company follows ASC topic 220. This statement establishes standards for reporting and display of comprehensive (loss)
income and its components. Comprehensive loss is net loss plus certain items that are recorded directly to shareholders' equity.
Other than foreign exchange gains and losses arising from cumulative translation adjustments, the Company has no other
comprehensive loss items.
(r) Fair value measurement
Under ASC topic 820, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an
orderly transaction between market participants at the measurement date (i.e., an exit price). ASC topic 820 establishes a
hierarchy for inputs to valuation techniques used in measuring fair value that maximizes the use of observable inputs and
minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs
are inputs that reflect assumptions market participants would use in pricing the asset or liability developed based on market data
obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company's own assumptions
about the assumptions market participants would use in pricing the asset or liability developed based on the best information
available in the circumstances. There are three levels to the hierarchy based on the reliability of inputs, as follows:
● Level 1 - Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.
● Level 2 - Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or
indirectly. Level 2 inputs include quoted prices for similar assets or liabilities in active markets, or quoted prices for
identical or similar assets and liabilities in markets that are not active.
● Level 3 - Unobservable inputs for the asset or liability.
The degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3.
Page 12
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
3.
Significant accounting policies (continued)
(s) Future Accounting pronouncements
In March 2013, the FASB provided amendments to ASU No. 2013-05 “Foreign Currency Matters (Topic 830): Parent’s
Accounting for the Cumulative Translation Adjustment upon Derecognition of Certain Subsidiaries or Groups of Assets within a
Foreign Entity or of an Investment in a Foreign Entity (a consensus of the FASB Emerging Issues Task Force)”. The
amendments are effective prospectively for reporting periods beginning after December 15, 2013. Early adoption and
retrospective application are permitted. The Company does not expect the adoption of the amendments to have a material impact
on the Company’s financial position, results of operations or cash flow.
In July 2013, the FASB issued ASU No. 2013-11, Presentation of an Unrecognized Tax Benefit When a Net Operating Loss
Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists, which requires an entity to present an unrecognized tax
benefit as a reduction of a deferred tax asset for a net operating loss (NOL) carryforward, or similar tax loss or tax credit
carryforward, rather than as a liability when (1) the uncertain tax position would reduce the NOL or other carryforward under
the tax law of the applicable jurisdiction and (2) the entity intends to use the deferred tax asset for that purpose. The ASU does
not require new recurring disclosures. It is effective prospectively for fiscal years, and interim periods within those years,
beginning after December 15, 2013. Early adoption and retrospective application are permitted. The Company does not expect
the adoption of the amendments to have a material impact on the Company’s financial position, results of operations or cash
flow.
In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers, requiring an entity to recognize the
amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The updated
standard will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. ASU 2014-09 is
effective for annual reporting periods beginning after December 15, 2016. Early adoption is not permitted. The guidance permits
companies to either apply the requirements retrospectively to all prior periods presented, or apply the requirements in the year of
adoption, through a cumulative adjustment. The Company is in the process of evaluating the impact of adoption on the
Company’s financial position, results of operations or cash flow.
On June 19, 2014, the FASB issued ASU 2014-12 in response to the consensus of the Emerging Issues Task Force on EITF
Issue 13-D.2 The ASU clarifies that entities should treat performance targets that can be met after the requisite service period of
a share-based payment award as performance conditions that affect vesting. Therefore, an entity would not record compensation
expense (measured as of the grant date without taking into account the effect of the performance target) related to an award for
which transfer to the employee is contingent on the entity’s satisfaction of a performance target until it becomes probable that
the performance target will be met. No new disclosures are required under the ASU. The ASU’s guidance is effective for all
entities for reporting periods (including interim periods) beginning after December 15, 2015. Early adoption is permitted. The
Company does not expect the adoption of the amendments to have a material impact on the Company’s financial position,
results of operations or cash flow.
On August 27, 2014, the FASB issued ASU 2014-15, which provides guidance on determining when and how to disclose going-
concern uncertainties in the financial statements. The new standard requires management to perform interim and annual
assessments of an entity’s ability to continue as a going concern within one year of the date the financial statements are issued.
An entity must provide certain disclosures if “conditions or events raise substantial doubt about the entity’s ability to continue as
a going concern.” The ASU applies to all entities and is effective for annual periods ending after December 15, 2016, and interim
periods thereafter, with early adoption permitted. The Company is in the process of evaluating the amendments to determine if
they have a material impact on the Company’s financial position, results of operations or cash flow.
Page 13
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
4.
Accounts receivable
The Company currently has no debt agreements in place whereby any amount of receivables serve as collateral. The Company has no
off-balance-sheet credit exposures and has no foreclosed or repossessed assets. The Company has had no impaired loans related to
receivables and has identified no loss contingencies related to the receivables at November 30, 2014 and November 30, 2013. Risks
and uncertainties and credit quality information related to accounts receivable have been disclosed in Note 17.
5.
Property and equipment
Computer equipment
Computer software
Furniture and fixtures
Laboratory equipment
Leasehold improvements
Laboratory equipment under capital lease
Computer equipment under capital lease
Computer equipment
Computer software
Furniture and fixtures
Laboratory equipment
Leasehold improvements
Laboratory equipment under capital lease
Computer equipment under capital lease
Accumulated
amortization
$
November 30, 2014
Net book
value
$
196,237
99,027
98,406
1,658,299
1,142,122
124,928
69,853
3,388,872
51,098
20,124
28,284
1,361,414
-
151,372
6,605
1,618,897
Accumulated
amortization
$
November 30, 2013
Net book
value
$
177,831
79,603
91,335
1,404,479
1,087,083
100,138
67,022
3,007,491
51,023
34,259
35,355
974,142
24,648
102,446
9,436
1,231,309
Cost
$
247,335
119,151
126,690
3,019,713
1,142,122
276,300
76,458
5,007,769
Cost
$
228,854
113,862
126,690
2,378,621
1,111,731
202,584
76,458
4,238,800
Depreciation for the year ended November 30, 2014 was $381,385 (2013 - $396,814; 2012 - $452,303).
Property and equipment are reviewed for impairment whenever events or changes in circumstances indicate that the carrying value of
an asset may not be recoverable. Impairment is assessed by comparing the carrying amount of an asset with the sum of the
undiscounted cash flows expected from its use and disposal, and as such requires the Company to make significant estimates on
expected revenues from the commercialization of its products and services and the related expenses. The Company records a write-
down for long-lived assets which have been abandoned and do not have any residual value. For the year ended November 30, 2014,
the Company recorded a $Nil write-down of long-lived assets (2013 - $Nil; 2012 – $107,123).
Page 14
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
6.
Accrued liabilities
Professional fees
Other
7.
Due to related parties
November 30,
November 30,
2014
$
349,957
325,530
675,487
2013
$
468,986
200,335
669,321
Amounts due to the related parties were payable to entities controlled by two shareholders who are also officers and directors of the
Company.
Promissory note payable to two directors and officers of the Company, unsecured, 6% annual
interest rate on the outstanding loan balance (i) (2014 - C$Nil; 2013 - C$778,491)
Note payable to an entity controlled by shareholders, officers and directors of the Company,
unsecured, non-interest bearing with no fixed repayment terms(ii) (2014 - C$Nil; 2013 -
$28,167)
Convertible debenture payable to two directors and officers of the Company, unsecured, 12%
annual interest rate, payable monthly(iii)
(i)
Promissory note payable
November 30,
2014
$
November 30,
2013
$
-
733,042
-
-
26,522
759,564
1,377,302
2,105,406
The promissory note dated September 10, 2004 issued by IPC Corp to Dr. Isa Odidi and Dr. Amina Odidi (the “Promissory
Note”), principal shareholders, directors and executive officers of the Company was amended effective October 22, 2009
(“effective date”), to provide that the principal amount thereof shall be payable when payment is required solely out of
(i) revenues earned by IPC Corp following the effective date, and/or proceeds received by any IPC Company from any
offering of its securities following the effective date, other than the proceeds from the transactions completed in February
2011, March 2012, March 2013 and July 2013 (Note 10) and/or amounts received by IPC Corp for scientific research tax
credits of IPC Corp and (ii) up to C$800,000 from the Net Cash (as defined in the IPC Arrangement Agreement). During the
year ended November 30, 2014, the entire outstanding related party loan principal in the amount of $665,226 (C$736,685)
was repaid (2013 - $Nil; 2012 -$Nil) and interest payments of $48,545 (C$53,762) (2013 - $16,640; 2012 - $39,173) in
respect of the Promissory Note was made by the Company in accordance with the terms of the IPC Arrangement Agreement.
(ii)
Note payable
During the year ended November 30, 2014, the note payable was repaid.
Page 15
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
7.
Due to related parties (continued)
(iii)
Convertible debenture
On January 10, 2013, the Company completed a private placement financing of the Debenture, which had an original
maturity date of January 1, 2015. The Debenture bears interest at a rate of 12% per annum, payable monthly, is pre-payable
at any time at the option of the Company, and is convertible at any time into 500,000 common shares at a conversion price
of $3.00 per common share at the option of the holder.
Dr. Isa Odidi and Dr. Amina Odidi, principal shareholders, directors and executive officers of the Company purchased the
Debenture and provided the Company with the $1.5 million of the proceeds for the Debenture.
The conversion price of the Debenture is in U.S. dollars and at issuance IPC’s functional currency at the time of issuance
was Canadian dollars. Under U.S. GAAP where the conversion price of the Debenture is denominated in a currency other
than an entity's functional currency, the conversion option meets the definition of an embedded derivative. The conversion
option was bifurcated from its host contract and the fair value of the conversion option characterized as an embedded
derivative upon issuance. The embedded derivative is presented together on a combined basis with the host contract. The
derivative is re-measured at the end of every reporting period with the change in value reported in the consolidated
statements of operations and comprehensive loss.
The proceeds received from the Debenture less the initial amount allocated to the embedded derivative were allocated to the
liability and were accreted over the life of the Debenture using the imputed rate of interest.
Effective December 1, 2013, the Company changed its functional currency such that the conversion option no longer meets
the criteria for bifurcation and was prospectively reclassified to equity under ASC 815. The conversion option value at
December 1, 2013 of $728,950 was reclassified from convertible debenture to additional paid-in capital.
Effective October 1, 2014, the maturity date of the Debenture was extended to July 1, 2015. Under ASC 470-50, the change
in the debt instrument was accounted for as a modification of debt. The increase in the fair value of the conversion option at
the date of the modification, in the amount of $126,414, was recorded as a reduction in the carrying value of the debt
instrument with a corresponding increase to additional paid-in-capital. The carrying amount of the debt instrument is
accreted over the remaining life of the Debenture using an imputed rate of interest.
Accreted interest expense during the year ended November 30, 2014 is $127,261 (2013 - $96,556; 2012 -$Nil), and has been
included in the consolidated statements of operations and comprehensive loss. In addition, the coupon interest on the
Debenture for the year ended November 30, 2014 is $179,877 (2013 - $159,671; 2012 - $Nil), and has also been included in
the consolidated statements of operations and comprehensive loss.
8.
Employee costs payable
As at November 30, 2014, the Company had $Nil (2013 - $336,327) salaries payable to Dr. Isa Odidi and Dr. Amina Odidi, principal
shareholders, directors and executive officers of the Company and $181,204 (2013 - $172,289) for other amounts payable to certain
employees. These balances are due on demand and therefore presented as current liabilities.
Page 16
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
9.
Lease obligations
The Company leases facilities under an operating lease which expires in November 2015, with an option to extend the lease for five
additional years on terms the Company currently believe to be favourable. The Company also leases various computers and
equipment under capital leases. Future minimum lease payments under leases with terms of one year or more are as follows at
November 30, 2014:
Year ending November 30,
2015
2016
2017
Less: amounts representing interest at 14%
Less: current portion
Balance, long-term portion
10.
Capital stock
Authorized, issued and outstanding
Capital
Lease
$
27,272
27,272
19,052
73,596
9,987
63,609
21,449
42,160
Operating
Lease
$
78,308
-
-
78,308
-
78,308
78,308
-
(a) The Company is authorized to issue an unlimited number of common shares, all without nominal or par value and an unlimited
number of preference shares. As at November 30, 2014 the Company has 23,456,611 (2013 – 21,430,611) common shares issued
and outstanding, and no preference shares issued and outstanding.
Two officers and directors of IPC owned directly and through their family holding company (“Odidi Holdco”) 5,997,751 (2013 -
5,997,751) common shares or approximately 26% (2013 – 28%) of IPC.
Each common share of the Company entitles the holder thereof to one vote at any meeting of shareholders of the Company,
except meetings at which only holders of a specified class of shares are entitled to vote.
Common shares of the Company are entitled to receive, as and when declared by the board of directors of the Company,
dividends in such amounts as shall be determined by the board. The holders of common shares of the Company have the right to
receive the remaining property of the Company in the event of liquidation, dissolution, or winding-up of the Company, whether
voluntary or involuntary.
The preference shares may at any time and from time to time be issued in one or more series. The board of directors will, by
resolution, from time to time, before the issue thereof, fix the rights, privileges, restrictions and conditions attaching to the
preference shares of each series. Except as required by law, the holders of any series of preference shares will not as such be
entitled to receive notice of, attend or vote at any meeting of the shareholders of the Company. Holders of preference shares will
be entitled to preference with respect to payment of dividends and the distribution of assets in the event of liquidation, dissolution
or winding-up of the Company, whether voluntary or involuntary, or any other distribution of the assets of the Company among
its shareholders for the purpose of winding up its affairs, on such shares over the common shares of the Company and over any
other shares ranking junior to the preference shares.
Page 17
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
10.
Capital stock (continued)
Authorized, issued and outstanding
(b) In March 2012, the Company completed a registered direct common share offering for gross proceeds of $5,000,000. The
Company sold an aggregate of 1,818,182 shares to U.S. institutional investors at a price of $2.75 per share. Professional,
regulatory and other costs in the amount of $779,271 directly attributable to the common share offering have been recorded as
share issuance costs in the statement of shareholders’ equity (deficiency).
(c) In March 2013, the Company completed a registered direct unit offering for gross proceeds of $3,121,800 at a price of $1.72 per
unit. The Company sold units comprised of an aggregate of 1,815,000 common shares and warrants to purchase an additional
453,750 common shares. The warrants are exercisable for a term of five years and an exercise price of $2.10 per common share.
After placement agent fees and offering expenses, the Company received net proceeds from the offering of approximately $2.7
million. The Company determined the fair value of the warrant liability at issuance to be $407,558 using the Black-Scholes
Option Pricing Model (Note 14). The direct costs related to the issuance of the common shares were $389,289 and were recorded
as an offset against shareholders’ deficiency and the direct costs related to the issuance of the warrants were $57,531 and were
recorded in the consolidated statements of operations and comprehensive loss.
(d) In July 2013, the Company completed an underwritten public offering for gross proceeds of $3,075,000 at a price of $2.05 per
unit. The Company sold units comprised of an aggregate of 1,500,000 common shares and warrants to purchase an additional
375,000 common shares. The warrants are exercisable for a term of five years and have an exercise price of $2.55 per common
share. After placement agent fees and estimated offering expenses, the Company received net proceeds from the offering of
approximately $2.5 million. The Company determined the fair value of the warrant liability at issuance to be $328,350 using the
Black-Scholes Option Pricing Model (Note 14). The direct costs related to the issuance of the common shares were $467,989 and
were recorded as an offset against shareholders’ deficiency and the direct costs related to the issuance of the warrants were
$57,525 and were recorded in the consolidated statements of operations and comprehensive loss.
(e) In November 2013, the Company entered into an equity distribution agreement with Roth Capital Partners, LLC (“Roth”),
pursuant to which the Company may from time to time sell up to 5,305,484 of the Company’s common shares for up to an
aggregate of $16.8 million (or such lesser amount as may be permitted under applicable securities laws and regulations) through
at-the-market issuances on the NASDAQ or otherwise. Under the equity distribution agreement, the Company may at its
discretion, from time to time, offer and sell common shares through Roth or directly to Roth for resale.
An aggregate of 1,689,500 common shares were sold for gross proceeds of $6,571,673 in the year ended November 30, 2014. No
sales were made under the equity distribution agreement in the year ended November 30, 2013. Additional sales of common
shares through Roth, if any, will be made at such time and at such price as are acceptable to the Company, from time to time, by
means of ordinary brokers' transactions on the NASDAQ or otherwise at market prices prevailing at the time of sale or as
determined by the Company. The Company is not required to sell shares under the equity distribution agreement. The Company
will pay Roth a commission, or allow a discount, of 2.75% of the gross proceeds that the Company received from any additional
sales of common shares under the equity distribution agreement. The Company has also agreed to reimburse Roth for certain
expenses relating to the offering. The direct costs related to the facility were $419,777 and were recorded as deferred offering
costs as at November 30, 2013. Additional direct costs related to the facility of $392,110 incurred in the year ended November
30, 2014 were recorded as share issuance costs against the cost of the shares issued and recognized in capital stock as at
November 30, 2014.
(f) Direct costs in the amount of $271,381 related to the Company’s filing of a base shelf prospectus filed in May 2014 and declared
effective in June 2014 were recorded as deferred financing costs as at November 30, 2014 and will be recorded as share issuance
cost against future share offerings.
Page 18
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
11.
Options
All grants of options to employees after October 22, 2009 are made from the Employee Stock Option Plan (the “Employee Stock
Option Plan”). The maximum number of common shares issuable under the Employee Stock Option Plan is limited to 10% of the
issued and outstanding common shares of the Company from time to time, or 2,345,661 based on the number of issued and
outstanding common shares as at November 30, 2014. As at November 30, 2014, 2,094,268 options are outstanding and there were
251,393 options available for grant under the Employee Stock Option Plan. Each option granted allows the holder to purchase one
common share at an exercise price not less than the closing price of the Company's common shares on the Toronto Stock Exchange
on the last trading day prior to the grant of the option. Options granted under these plans generally have a maximum term of 10 years
and generally vest over a period of up to three years.
In August 2004, the Board of Directors of IPC Ltd. approved a grant of 2,763,940 performance-based stock options, to two
executives who were also the principal shareholders of IPC Ltd. The vesting of these options is contingent upon the achievement of
certain performance milestones. A total of 1,658,364 performance-based stock options have been vested as of November 30, 2014.
Under the terms of the original agreement these options were to expire in September 2014. Effective March 27, 2014, the Company’s
shareholders approved the two year extension of the performance-based stock option expiry date to September 2016. These options
were outstanding as at November 30, 2014.
As a result of the modification of the performance based stock option expiry date, the Company recorded additional compensation
costs of $1,066,991 related to vested performance options during the year ended November 30, 2014.
In the year ended November 30, 2014, 479,001 (2013 – 391,000) stock options were granted to management, directors and
employees.
The fair value of each option grant is estimated on the date of grant using the Black-Scholes Option-Pricing Model, consistent with
the provisions of ASC topic 718.
Option pricing models require the use of subjective assumptions, changes in these assumptions can materially affect the fair value of
the options.
The Company calculates expected volatility based on historical volatility of the Company’s peer group that is publicly traded for
options that have an expected life that is more than four years. For options that have an expected life of less than four years the
Company uses its own volatility.
The expected term, which represents the period of time that options granted are expected to be outstanding, is estimated based on an
average of the term of the options.
The risk-free rate assumed in valuing the options is based on the U.S. treasury yield curve in effect at the time of grant for the
expected term of the option. The expected dividend yield percentage at the date of grant is Nil as the Company is not expected to pay
dividends in the foreseeable future.
Page 19
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
11.
Options (continued)
The weighted average fair value of employee stock options granted was estimated using the following assumptions:
Volatility
Risk-free interest rate
Expected life (in years)
Dividend yield
The weighted average grant date fair value per options granted
Details of stock option transactions are as follows:
November 30,
2014
55.0%
1.45%
5.60
-
2.10
$
November 30,
2013
64.0%
1.00%
7.00
-
1.05
$
November 30, 2014
November 30, 2013
Number
of
options
Weighted
average
exercise
price per
Weighted
average
grant
date
share
$
fair value
$
Number
of
options
Weighted
average
exercise
price per
Weighted
average
grant
date
share
$
fair value
$
Number
of
options
Weighted
average
exercise
price per
November 30, 2012
Weighted
average
grant
date
fair value
$
share
$
Outstanding,
beginning of
period,
Granted
Exercised
Forfeiture
Expired
Balance at end of
period
Options exercisable,
4,455,072
479,001
(48,000)
(27,832)
(33)
3.97
3.86
2.45
-
709.18
2.21 4,139,059
2.10 391,000
(3,500)
1.07
(67,000)
-
(4,487)
709.18
4.86
1.81
1.81
-
654.48
2.76 3,216,954
1.05 955,000
0.09
-
(32,862)
-
(33)
403.93
5.33
3.27
-
-
69.74
2.82
2.51
-
-
53.82
4,858,208
3.96
2.21 4,455,072
3.97
2.21 4,139,059
4.86
2.76
end of year
3,640,381
4.09
2.40 3,321,830
4.09
2.41 2,286,589
5.94
3.55
As of November 30, 2014, the exercise prices, weighted average remaining contractual life of outstanding options and weighted
average grant date fair values were as follows:
Page 20
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
11.
Options (continued)
Options outstanding
Options exercisable
Exercise
price
Under 2.50
5.00
10.00
100.00
500.00
1,000.00
-
-
-
-
-
2.51
5.01
10.01
300.00
500.01
Weighted
average
exercise
price per
share
$
-
3.43
-
39.75
331.15
770.13
3.96
Number
outstanding
-
4,818,501
-
35,703
3,971
33
4,858,208
Weighted
average
remaining
contract
life
(years)
Weighted
average
grant
due
fair value
$
Number
exercisable
-
2.40
-
2.87
1.30
0.29
-
-
1.80 3,600,674
-
35,703
3,971
33
3,640,381
-
31.19
223.52
493.31
Weighted
average
exercise
price per
share
$
-
3.36
-
39.75
331.15
770.13
4.09
Weighted
average
grant
date
fair value
$
-
1.87
-
31.19
223.52
493.31
Total unrecognized compensation cost relating to the unvested performance-based stock options at November 30, 2014 is
approximately $2,482,528 (2013 - $1,771,200). During the year ended November 30, 2013, a performance condition was met as the
FDA approved an ANDA for a certain drug, resulting in the vesting of 276,394 performance-based stock options. As a result, a stock-
based compensation expense of $442,800 relating to these stock options was recognized in research and development expense in the
year ended November 30, 2013.
For the year ended November 30, 2014, 48,000 options were exercised for a cash consideration of $116,984. For the year ended
November 30, 2013, 3,500 options were exercised for a cash consideration of $5,965 and for the year ended November 30, 2012, no
options were exercised.
The following table summarizes the components of stock-based compensation expense.
Research and development
Selling, general and administrative
November 30,
November 30,
2014
$
2013
$
November 30,
2012
$
1,270,307
478,300
1,748,607
837,206
316,676
1,153,882
1,505,061
818,784
2,323,845
The Company has estimated its stock option forfeitures to be approximately 3% at November 30, 2014 (2013 - $Nil; 2012 - $Nil).
12.
Deferred share units
Effective May 28, 2010, the Company’s shareholders approved a Deferred Share Unit (“DSU”) Plan to grant DSUs to its non-
management directors and reserved a maximum of 110,000 common shares for issuance under the plan. The DSU Plan permits
certain non-management directors to defer receipt of all or a portion of their board fees until termination of the board service and to
receive such fees in the form of common shares at that time. A DSU is a unit equivalent in value to one common share of the
Company based on the trading price of the Company's common shares on the Toronto Stock Exchange.
Upon termination of board service, the director will be able to redeem DSUs based upon the then market price of the Company's
common shares on the date of redemption in exchange for any combination of cash or common shares as the Company may
determine.
Page 21
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
12.
Deferred share units (continued)
During the year ended November 30, 2014, one non-management board member elected to receive director fees in the form of DSUs
under the Company’s DSU Plan. As at November 30, 2014, 49,009 DSUs are outstanding and 60,991 DSUs are available for grant
under the DSU Plan.
Additional paid in capital
Accrued liability
20,807
3,759
5,968
1,338
39,547
9,181
20,591
2,325
36,727
9,688
12,199
4,611
November 30, 2014
shares
$
November 30, 2013
shares
$
November 30, 2012
shares
$
13.
Restricted share units
Effective May 28, 2010, the Company’s shareholders approved a Restricted Share Unit (“RSU”) Plan for officers and employees of
the Company and reserved a maximum of 330,000 common shares for issuance under the plan. The RSU Plan will form part of the
incentive compensation arrangements available to officers and employees of the Company and its designated affiliates. An RSU is a
unit equivalent in value to one common share of the Company. Upon vesting of the RSUs and the corresponding issuance of common
shares to the participant, or on the forfeiture and cancellation of the RSUs, the RSUs credited to the participant’s account will be
cancelled. No RSUs have been issued under the plan.
14. Warrants
All the warrants issued to date by the Company are denominated in U.S. dollars and at issuance IPC’s functional currency was the
Canadian dollar. Under U.S. GAAP, where the strike price of warrants is denominated in a currency other than an entity's functional
currency the warrants would not be considered indexed to the entity’s own stock and would consequently be considered to be a
derivative liability. The warrants, in specified situations, provide for certain compensation remedies to a holder if the Company fails
to timely deliver the shares underlying the warrants in accordance with the warrant terms. Subsequent changes in the fair value of the
warrants were recorded in the consolidated statements of operations and comprehensive loss.
In connection with the February 1, 2011 private offering, the Company issued 4,800,000 five year Series A common share purchase
warrants to purchase one half of a share of common stock at an exercise price of $2.50 per whole share and 4,800,000 two year Series
B common share purchase warrants to purchase one half of a share of common stock at an exercise price of $2.50 per whole share.
The Company also issued to the placement agents 96,000 warrants to purchase a share of common stock at an exercise price of $3.125
per share.
The holders of Series A common share purchase warrants and placement agents warrants are entitled to a cashless exercise under
which the number of shares to be issued will be based on the number of shares for which warrants are exercised multiplied by the
difference between market price of common share and the exercise price divided by the market price. Also under U.S. GAAP,
warrants with the cashless exercise option satisfying the explicit net settlement criteria are considered a derivative liability.
In the registered direct unit offering completed in March 2013, gross proceeds of $3,121,800 were received through the sale of the
Company’s units comprised of common stock and warrants.
The offering was the sale of 1,815,000 units at a price of $1.72 per unit, with each unit consisting of one share of common stock and a
five year warrant to purchase 0.25 of a share of common stock at an exercise price of $2.10 per share (“March 2013 Warrants”).
The fair value of the March 2013 Warrants of $407,558 were initially estimated at closing using the Black-Scholes Option Pricing
Model, using volatilities of 63%, risk free interest rates of 0.40%, expected life of 5 years, and dividend yield of Nil.
Page 22
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
14. Warrants (continued)
In the underwritten public offering completed in July 2013, gross proceeds of $3,075,000 were received through the sale of the
Company’s units comprised of common stock and warrants. The offering was the sale of 1,500,000 units at a price of $2.05 per unit,
each unit consisting of one share of common stock and a five year warrant to purchase 0.25 of a share of common stock at an exercise
price of $2.55 per share (“July 2013 Warrants”).
The fair value of the July 2013 Warrants of $328,350 were initially estimated at closing using the Black-Scholes Option Pricing
Model, using volatilities of 62.4%, risk free interest rates of 0.58%, expected life of 5 years, and dividend yield of Nil.
Effective December 1, 2013, the Company changed its functional currency to the U.S dollar such that the warrants are considered
indexed to the Company’s own stock and were prospectively classified as equity under ASC 480. The warrant liability value at
December 1, 2013 of $5,438,022 was reclassified from warrant liabilities to additional paid-in capital.
The following table provides information on the 5,879,300 warrants outstanding and exercisable as of November 30, 2014:
Warrant
Series A Warrants
March 2013 Warrants
July 2013 Warrants
Exercise price
Number
outstanding
Expiry
Shares issuable
upon exercise
2.50
2.10
2.55
3,285,000 February 1, 2016
1,724,300 March 22, 2018
870,000 July 31, 2018
5,879,300
1,642,500
431,075
217,500
2,291,075
During the year ended November 30, 2014, there were cash exercises in respect of 481,000 warrants (2013 – 770,700) and no cashless
exercise (2013 – Nil) of warrants, resulting in the issuance of 288,500 (2013 – 205,175) and Nil (2013 – Nil) common shares,
respectively. For the warrants exercised the Company recorded a charge to capital stock of $1,291,436 (2013- $980,382) comprised of
proceeds of $781,220 (2013 - $980,382) and the associated amount of $510,216 (2013 - Nil) previously recorded in additional paid in
capital.
Details of warrant transactions are as follows:
Outstanding, December 1, 2013
Issued
Exercised
Expired
Outstanding, November 30, 2014
Series A
Warrants
Placement
Agent Warrants
March 2013
Warrants
July 2013
Warrants
Total
3,670,000
-
(385,000)
-
3,285,000
96,000 1,724,300
-
-
-
(96,000)
-
-
- 1,724,300
870,000 6,360,300
-
(481,000)
-
870,000 5,879,300
-
-
-
Series A
Warrants
Series B
Warrants
Placement
Agent Warrants
March 2013
Warrants
July 2013
Warrants
Total
Outstanding, December 1, 2012
Issued
Exercised
Expired
Outstanding, November 30, 2013
3,720,000 3,470,000
-
-
-
(50,000)
- (3,470,000)
-
3,670,000
-
96,000
- 7,286,000
- 1,815,000 1,500,000 3,315,000
-
(770,700)
- (3,470,000)
-
870,000 6,360,300
(90,700)
-
96,000 1,724,300
(630,000)
Page 23
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
14. Warrants (continued)
U.S. GAAP requires the fair value of these liabilities be re-measured at the end of every reporting period with the change in value
reported in the consolidated statements of operations and comprehensive loss.
Accordingly, using the Black-Scholes Option Pricing Model, the fair market value of the warrants are as follows:
November 30, 2014 November 30, 2013
$
$
Series B Warrants
Placement Agent Warrants
Series A Warrants
March 2013 Warrants
July 2013 Warrants
-
-
-
-
-
-
Using the following assumptions as of November 30, 2013:
Warrant
Placement Agent Warrants
Series A Warrants
March 2013 Warrants
July 2013 Warrants
Number
outstanding
96,000
3,670,000
1,724,300
870,000
Volatility
%
86.51
67.93
54.84
55.51
Risk-free
rate
%
0.12
0.12
0.64
0.64
-
112,550
3,790,736
1,040,788
493,948
5,438,022
Expected
life
years
0.2
2.2
4.3
4.7
The change in the fair value of the warrants from the previously recorded amount to November 30, 2014 amounting to Nil (2013 -
loss of $3,356,534; 2012 – gain of $3,841,233) has been recorded as a fair value adjustment of derivative liability in the consolidated
statements of operations and comprehensive loss.
15.
Income taxes
The Company files Canadian income tax returns for its Canadian operations. Separate income tax returns are filed as locally required.
The total provision for income taxes differs from the amount which would be computed by applying the Canadian income tax rate to
loss before income taxes. The reasons for these differences are as follows:
Page 24
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
15.
Income taxes (continued)
Statutory income tax rate
Statutory income tax recovery
Increase (decrease) in income taxes
Non-deductible expenses/ non-taxable income
Change in valuation allowance
Difference in net income before taxes between Canadian and U.S
dollar
Investment tax credit
Financing costs booked to equity
Ontario tax rate change
Foreign exchange change
True up of tax returns
Tax loss expired, etc.
November 30,
November 30,
November 30,
2014
%
2013
%
26.5
26.5
$
$
2012
%
27.0
$
(1,021,934)
(3,046,180)
(1,632,406)
417,879
(995,957)
1,446,008
1,248,045
(399,748)
3,217,198
160,316
(9,114)
(208,271)
-
985,544
82,939
588,598
-
-
(164,308)
(307,262)
-
746,667
77,030
-
-
-
(561,988)
-
(420,990)
(230,695)
28,629
-
-
The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of temporary differences
between the carrying amounts and the tax basis of assets and liabilities and certain carry-forward balances. Significant temporary
differences and carry-forwards are as follows:
Deferred tax assets
Non-capital loss carry-forwards
Book and tax basis differences on assets and liabilities
Other
Ontario harmonization tax credit
Investment tax credit
Undeducted research and development expenditures
Valuation allowances for deferred tax assets
Net deferred tax assets
November 30,
November 30,
November 30,
2014
$
2013
$
2012
$
6,528,099
1,006,667
47,180
371,160
2,327,722
2,183,486
12,464,314
(12,464,314)
-
6,831,991
992,378
37,136
399,831
2,324,856
2,180,640
12,766,832
(12,766,832)
-
6,031,917
773,590
17,590
427,355
2,089,238
2,179,097
11,518,787
(11,518,787)
-
At November 30, 2014, the Company had cumulative operating losses available to reduce future years’ income for income tax
purposes:
Page 25
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
15.
Income taxes (continued)
Canadian income tax losses expiring in the year ended November 30,
2015
2025
2026
2027
2028
2029
2030
2031
2032
2033
2034
United States Federal income tax losses expiring in the year ended November 30,
2024
2025
2026
2032
Federal
$
(309,404)
(476,656)
-
(1,274,199)
(750,084)
(554,905)
(3,369,225)
(5,287,252)
(5,424,702)
(4,714,446)
(2,394,256)
(24,555,129)
$
12,542
16,234
34,523
5,312
68,611
At November 30, 2014, the Company had a cumulative carry-forward pool of Federal SR&ED expenditures in the amount of
approximately $10,215,000 (2013 - $10,310,000) which can be carried forward indefinitely.
At November 30, 2014, the Company had approximately $371,000 (2013 - $400,000) of Ontario harmonization credits, which will
expire in the November 30, 2015 taxation year. These credits are subject to a full valuation allowance as they are not more likely than
not to be realized.
At November 30, 2014, the Company had approximately $2,328,000 (November 30, 2013 - 2,325,000) of unclaimed ITCs which
expire from 2025 to 2033. These credits are subject to a full valuation allowance as they are not more likely than not to be realized.
The net deferred tax assets have been fully offset by a valuation allowance because it is not more likely than not the Company will
realize the benefit of these deferred tax assets. The Company does not have any recognized tax benefits as of November 30, 2014 or
November 30, 2013.
The Company files unconsolidated federal income tax returns domestically and in foreign jurisdictions. The Company has open tax
years from 2007 to 2014 with tax jurisdictions including Canada and the U.S. These open years contain certain matters that could be
subject to differing interpretations of applicable tax laws and regulations, as they relate to amount, timing, or inclusion of revenues
and expenses.
The Company did not incur any interest expense related to uncertain tax positions in 2014, 2013 and 2012 or any penalties in those
years. The Company had no accrued interest and penalties as of November 30, 2014 and 2013.
The Company had no unrecognized tax benefits in 2014, 2013 and 2012, and the Company does not expect that the unrecognized tax
benefit will increase within the next twelve months.
Page 26
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
16.
Contingencies
From time to time, the Company may be exposed to claims and legal actions in the normal course of business. As at November 30,
2014, and continuing as at February 23, 2015 there were no material pending or threatened litigation claims outstanding other than the
ones described in the following paragraphs.
Pursuant to an arrangement agreement between Vasogen and Cervus LP (“Cervus”) dated August 14, 2009 (the "Cervus Agreement"),
Vasogen and a Vasogen subsidiary (“New Vasogen”) entered into an indemnity agreement (the "Indemnity Agreement"), which
became an obligation of the Company as of October 22, 2009. The Indemnity Agreement is designed to provide Cervus with
indemnification for claims relating to Vasogen's and New Vasogen's business that are brought against Cervus in the future, subject to
certain conditions and limitations. The Company's obligations under the Indemnity Agreement relating to the Tax pools defined in the
Indemnity Agreement are limited to an aggregate of C$1,455,000 with a threshold amount of C$50,000 before there is an obligation to
make a compensation payment. The Company does not presently expect to have to pay any amount under this Indemnity Agreement.
On or about August 8, 2014, Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. filed a complaint against
Intellipharmaceutics Corp. and Intellipharmaceutics International Inc. for alleged patent infringement in the United States District
Court for the District of Delaware in respect of Intellipharmaceutics’ development of a generic of the branded drug Pristiq® (O-
desmethylvenlafaxine succinate extended release tablets in 50 and 100 mg dosage strengths). A similar complaint for patent
infringement was filed on August 11, 2014 by the same parties in the District Court for the Southern District of New York. The
above-noted litigation has been settled effective February 2, 2015, and the Parties have stipulated to the full and final dismissal of all
litigation noted above, without prejudice and without costs. All other terms of the settlement are confidential.
On or about September 26, 2014, Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. and Angelini Pharma Inc. filed a
complaint against Intellipharmaceutics International Inc., Intellipharmaceutics Corp., and Intellipharmaceutics Ltd. for alleged patent
infringement in the United States District Court for the District of Delaware in respect of Intellipharmaceutics’ development of a
generic of the branded drug Oleptro™ (trazodone hydrochloride extended-release tablets in 150 and 300 mg dosage strengths). The
complaint was filed by the plaintiffs and subsequently served. The Company believes that the likelihood of having to pay any
damages or other penalty to the plaintiffs in connection with the resolution of this complaint in its anticipated course is remote,
although no assurance can be provided to this effect. The parties are engaged in settlement discussions, although we cannot predict
whether these discussions will result in a settlement.
17.
Financial instruments
(a) Fair values
The Company follows ASC topic 820, “Fair Value Measurements” which defines fair value, establishes a framework for
measuring fair value, and expands disclosures about fair value measurements. The provisions of ASC 820 apply to other
accounting pronouncements that require or permit fair value measurements. ASC 820 defines fair value as the exchange price
that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for
the asset or liability in an orderly transaction between market participants at the measurement date; and establishes a three level
hierarchy for fair value measurements based upon the transparency of inputs to the valuation of an asset or liability as of the
measurement date.
Page 27
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
17.
Financial instruments (continued)
(a) Fair values (continued)
Inputs refers broadly to the assumptions that market participants would use in pricing the asset or liability, including assumptions
about risk. To increase consistency and comparability in fair value measurements and related disclosures, the fair value
hierarchy prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The three levels of the
hierarchy are defined as follows:
Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either
directly or indirectly for substantially the full term of the financial instrument.
Level 3 inputs are unobservable inputs for asset or liabilities.
The categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value
measurement.
The following table presents for each of the fair value hierarchies, the assets and liabilities that are measured at fair value on a
recurring basis as of November 30, 2014 and November 30, 2013:
(a) Convertible debt1
(b) Warrant liabilities2
Fair
Value
$
728,950
5,438,022
6,166,972
November 30, 2013
Level 1
$
-
-
-
Level 2
$
-
-
-
Level 3
$
728,950
5,438,022
6,166,972
(1) Conversion options are included in the convertible debenture on the consolidated balance sheet.
(2) Warrant liabilities are included on the consolidated balance sheet.
The key unobservable inputs related to valuing the conversion option and warrant liabilities are as follows:
Quantitative information about Level 3 Fair Value Measurements
Valuation
Techniques
Unobservable Input
Fair value at
November 30, 2013
$
Conversion option
728,950 Black-Scholes
Discount rate
Volatility
Range
0.12%
64.6%
Warrant liabilities
5,438,022 Black-Scholes
0.12% -
comparable annualized volatility(i) 54% -
Discount rate
0.64%
87%
(i) The Company calculates expected volatility based on historical volatility of the Company’s peer group that is publicly
traded for options that have an expected life that is more than four years.
(ii) The Company calculates the interest rate for the conversion option based on the Company’s estimated cost of raising
capital.
An increase/decrease in the volatility and/or an decrease/increase in the discount rate would have resulted in an
increase/decrease in the fair value of the conversion option and warrant liabilities.
Page 28
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
17.
Financial instruments (continued)
(a) Fair values (continued)
The change in fair value of the conversion option and the warrant liabilities was recorded as a fair value adjustment of
derivative liabilities in the consolidated statements of operations and comprehensive loss.
Reconciliation of Level 3 fair value measurements:
Opening balance
Transfer out from level 3(a)
Closing balance
Opening balance
Total gains or losses:
- in net loss(b)
- translation adjustment
Additions
Exercise
Closing balance
November 30, 2014
Conversion
Option
$
728,950
Warrant
liability
$
5,438,022
Total
$
6,166,972
(728,950)
-
(5,438,022)
-
(6,166,972)
-
November 30, 2013
Conversion
Option
$
-
533,149
(24,299)
220,100
-
728,950
Warrant
liability
$
1,960,893
3,356,534
(449,224)
735,908
(166,089)
5,438,022
Total
$
1,960,893
3,889,683
(473,523)
956,008
(166,089)
6,166,972
(a) As discussed in Note 7 and 14, the conversion option value of $728,950 and the warrant value of $5,438,022 at December
1, 2013 were reclassified to additional paid-in capital due to the change in functional currency.
(b) The total net loss related to the conversion option and warrant liability has been recorded under fair value adjustment
derivative liabilities on the consolidated statements of operations and comprehensive loss.
Fair value of financial assets and financial liabilities that are not measured at fair value on a recurring basis are as follows:
Financial Liabilities
Due to related parties(iii)
Convertible debt(iii)
November 30, 2014
November 30, 2013
Carrying
amount
$
Fair value
$
Carrying
amount
$
Fair value
$
-
1,377,302
-
1,379,808
759,564
1,376,456
515,130
1,290,683
(iii) The Company calculates the interest rate for the convertible debt and due to related parties based on the Company’s
estimated cost of raising capital and uses the discounted cash flow model to calculate the fair value of the convertible debt and
the amounts due to related parties.
Page 29
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
17.
Financial instruments (continued)
(a) Fair values (continued)
The carrying values of cash, accounts receivable, accounts payable and employee cost payable approximates their fair values
because of the short-term nature of these instruments.
(b)
Interest rate and credit risk
Interest rate risk is the risk that the value of a financial instrument might be adversely affected by a change in interest rates. The
Company does not believe that the results of operations or cash flows would be affected to any significant degree by a sudden
change in market interest rates, relative to interest rates on cash and cash equivalents, due to related parties and capital lease
obligations due to the short-term nature of these balances.
Trade accounts receivable potentially subjects the Company to credit risk. The Company provides an allowance for doubtful
accounts equal to the estimated losses expected to be incurred in the collection of accounts receivable.
The following table sets forth details of the aged accounts receivable that are not overdue as well as an analysis of overdue
amounts and the related allowance for doubtful accounts:
Total accounts receivable
Less allowance for doubtful accounts
Total accounts receivable, net
Not past due
Past due for more than 31 days but no more than 60 days
Past due for more than 91 days but no more than 120 days
Total accounts receivable, net
November 30,
November 30,
2014
$
2013
$
1,011,133
-
1,011,133
982,313
5,950
22,870
1,011,133
1,475,745
-
1,475,745
1,473,097
2,648
-
1,475,745
Financial instruments that potentially subject the Company to concentration of credit risk consist principally of uncollateralized
accounts receivable. The Company’s maximum exposure to credit risk is equal to the potential amount of financial assets. For
the years ended November 30, 2014 and November 30, 2013, Par accounted for substantially all the revenue and all the accounts
receivable of the Company.
The Company is also exposed to credit risk at period end from the carrying value of its cash. The Company manages this risk by
maintaining bank accounts with a Canadian Chartered Bank. The Company’s cash is not subject to any external restrictions.
(c) Foreign exchange risk
The Company has balances in Canadian dollars that give rise to exposure to foreign exchange (“FX”) risk relating to the impact
of translating certain non-U.S. dollar balance sheet accounts as these statements are presented in U.S. dollars. A strengthening
U.S. dollar will lead to a FX loss while a weakening U.S. dollar will lead to a FX gain. For each Canadian dollar balance of
$1.0 million, a +/- 10% movement in the Canadian currency held by the Company versus the US dollar would affect the
Company’s loss and other comprehensive loss by $0.1 million.
Balances denominated in foreign currencies that are considered financial instruments are as follows:
Page 30
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
17.
Financial instruments (continued)
(c) Foreign exchange risk (continued)
FX rates used to translate to U.S.
Assets
Cash
Liabilities
Accounts payable
Employee cost payable
Capital lease
Due to related party
Net exposure
(d) Liquidity risk
November 30, 2014
U.S
November 30, 2013
U.S
Canadian
1.0620
$
$
Canadian
1.1440
$
510,459
510,459
379,014
207,297
25,538
-
611,849
(101,390)
$
446,205
446,205
331,306
181,204
22,323
-
534,833
(88,628)
461,002
461,002
434,089
434,089
484,299
182,970
45,947
806,657
1,519,873
(1,058,871)
456,025
172,288
43,265
759,564
1,431,142
(997,053)
Liquidity risk is the risk that the Company will encounter difficulty raising liquid funds to meet commitments as they fall due. In
meeting its liquidity requirements, the Company closely monitors its forecasted cash requirements with expected cash
drawdown.
The following are the contractual maturities of the undiscounted cash flows of financial liabilities as at November 30, 2014:
Less than
3 months
$
3 to 6
months
$
6 to 9
months
$
9 months
1 year
$
November 30, 2014
Greater
than 1
year
$
Total
$
Third parties
Accounts payable
Accrued liabilities
Capital lease (note 9)
Related parties
668,069
675,487
5,148
-
-
5,288
-
-
5,431
Employee costs payable (Note 8)
Convertible debenture (Note 7)
181,204
44,353
1,574,261
-
-
44,353 1,515,277
49,641 1,520,708
-
-
5,581
-
-
5,581
-
-
42,160
668,069
675,487
63,608
-
181,204
- 1,603,983
42,160 3,192,351
Page 31
Intellipharmaceutics International Inc.
Notes to the consolidated financial statements
November 30, 2014, 2013 and 2012
(Stated in U.S. dollars)
18.
Segmented information
The Company's operations comprise a single reporting segment engaged in the research, development and manufacture of novel and
generic controlled-release and targeted-release oral solid dosage drugs. As the operations comprise a single reporting segment,
amounts disclosed in the financial statements for revenue, loss for the year, depreciation and total assets also represent segmented
amounts. In addition, all of the Company's long-lived assets are in Canada. The Company’s license and commercialization agreement
with Par accounts for substantially all of the revenue of the Company.
Revenue
United States
Total assets
Canada
Total property and equipment
Canada
November 30,
November 30,
November 30,
2014
$
2013
$
2012
$
8,769,693
8,769,693
1,527,474
1,527,474
107,091
107,091
7,875,035
4,379,501
2,474,878
1,618,897
1,231,309
1,535,703
Page 32
Item 19. Exhibits
EXHIBIT INDEX
Exhibit
Footnote
(5)
(5)
(5)
(5)
Number
1.1
1.2
4.1
4.2
4.3
4.51
4.52
4.53
4.54
4.55
4.56
4.57
4.58
4.59
4.6
4.61
4.62
4.63
4.64 (†)
4.65
4.66
8.1
11.1
12.1
12.2
(5)
Articles of Incorporation of the Company and Amendments thereto
By-laws of the Company
IPC Arrangement Agreement
The acknowledgement and agreement of the Company dated October 22, 2009 to be bound by the performance based stock option
agreement dated September 10, 2004 pursuant to which Drs. Isa and Amina Odidi are entitled to purchase up to 2,763,940 of the
Company’s shares upon payment of U.S.$3.62 per share, subject to satisfaction of the performance vesting conditions
The amended and restated promissory note dated October 22, 2009 for up to $2,300,000 issued by Intellipharmaceutics Corp. to Isa
Odidi and Amina Odidi for advances that may be made by them from time to time to the Company
Securities purchase agreement for February 1, 2011 private placement
(4)
Registration rights agreement for February 1, 2011 private placement
(4)
(4)
Combined Series A/B common share purchase warrant for February 1, 2011 private placement
Placement Agent Agreement between Intellipharmaceutics International Inc. and Roth Capital Partners, LLC, dated March 9, 2012 (6)
(6)
Form of Subscription Agreement (incorporated by reference to Exhibit A attached to Exhibit 4.54
(3)
12% convertible term debenture dated January 10, 2013 in principal amount of $1,500,000
(3)
Lease as amended between Finley W. McLachlan Ltd. and Intellipharmaceutics Corp. for premises at 30 Worcester Road, Toronto,
Ontario, Canada.
Placement Agent Agreement between Intellipharmaceutics International Inc. and Roth Capital Partners, LLC, Brean Capital, LLC
and Maxim Group, LLC, dated March 19, 2013
Form of Subscription Agreement (incorporated by reference to Exhibit A attached to Exhibit 4.58)
Form of Warrants (incorporated by reference to Exhibit B attached to Exhibit 4.58)
Underwriting Agreement between Intellipharmaceutics International Inc. and Maxim Group, LLC, as representative of the
underwriters named in Schedule I thereto, dated July 26, 2013
Form of Warrants
Equity Distribution Agreement between Intellipharmaceutics International Inc. and Roth Capital Partners, LLC, dated November
27, 2013
License and Commercialization Agreement dated as of November 21, 2005, between Intellipharmaceutics Corp., and Par
Pharmaceutical, Inc., as amended by the First Amendment To License and Commercialization Agreement dated as of August 2011,
and as further amended by the Second Amendment to License and Commercialization Agreement dated as of September 24, 2013
Fifth Amendment to Lease Agreement dated November 28, 2014 between Finley W. McLachlan Properties Inc. and
Intellipharmaceutics Corp. for premises at 30 Worcester Road, Toronto, Ontario, Canada
Extension of Debenture Maturity Date dated October 1, 2014 to that certain12% convertible term debenture dated January 10, 2013
in principal amount of $1,500,000
List of subsidiaries
Code of Business Conduct and Ethics
Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934
Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934
(1)
(5)
(1)
(1)
(7)
(7)
(8)
(8)
(9)
(7)
(2)
(1)
(1)
- 93 -
13.1
13.2
15.1
101
Certification of the Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Certification of the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Consent of Independent Registered Public Accounting Firm
XBRL (Extensible Business Reporting Language). The following materials from Intellipharmaceutics International Inc.’s Annual
(1)
(1)
(1)
(1) (10)
Report on Form 20-F for the fiscal year-ended November 30, 2014, formatted in XBRL:
(i) Consolidated balance sheets as at November 30, 2014 and 2013
(ii) Consolidated statements of operations and comprehensive loss for the years ended November 30, 2014, 2013 and
2012
(iii) Consolidated statements of shareholders’ equity (deficiency) for the years ended November 30, 2014, 2013 and 2012
(iv) Consolidated statements of cash flows for the years ended November 30, 2014, 2013 and 2012
(v) Notes to the consolidated financial statements
(1)
(2)
(3)
(4)
(5)
Filed as exhibits to this annual report on Form 20-F for the fiscal year ended November 30, 2014.
Incorporated herein by reference to the Company’s Amendment No. 1 on Form 20-F/A for the fiscal year ended November 30,
2013, as filed on April 4, 2014.
Incorporated herein by reference to the Company’s annual report on Form 20-F for the fiscal year ended November 30, 2013 as
filed on February 18, 2014.
Incorporated herein by reference to the Company’s annual report on Form 20-F for the fiscal year ended November 30, 2012 as
filed on January 31, 2013.
Incorporated herein by reference to the Company’s annual report on Form 20-F for the fiscal year ended November 30, 2010 as
filed on May 31, 2011.
(6) Incorporated herein by reference to the Company’s report on Form 6-K for the month of March 2012 as filed on March 9, 2012.
(7) Incorporated herein by reference to the Company’s report on Form 6-K for the month of March 2013 as filed on March 19, 2013.
(8) Incorporated herein by reference to the Company’s report on Form 6-K for the month of July 2013 as filed on July 26, 2013 (SEC
Accession No. 0001171843-13-002968).
(9) Incorporated herein by reference to the Company’s report on Form 6-K for the month of November 2013 as filed on November 27,
2013.
(10)
XBRL information is furnished and not filed or a part of a registration statement or prospectus for purposes of Sections 11 or 12 of
the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as
amended, and otherwise is not subject to liability under these sections.
† Confidential treatment has been granted for certain portions of this exhibit. Omitted portions have been filed separately with the
Securities and Exchange Commission.
- 94 -
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the
undersigned to sign this annual report on its behalf.
SIGNATURES
Intellipharmaceutics International Inc.
/s/ Domenic Della Penna
Domenic Della Penna
Chief Financial Officer (Principal Financial Officer),
Intellipharmaceutics International Inc.
February 26, 2015
Exhibit 4.65
Fifth Amendment to Lease Agreement
This Fifth Amendment to Lease Agreement ("Amendment”) is made and entered into as of the 28th day of November 2014, by and between
Finley W. McLachlan Properties Inc., (the "Landlord") and IntelliPharmaCeutics Corp., (the "Tenant”)
WHEREAS, Finley W. McLachlan Limited., and Finley W. McLachlan Properties Inc., agreed to amalgamate pursuant to an
Amalgamation Agreement dated July 31st 2014 and effective August 1, 2014. The name of the amalgamated corporation to be Finley W.
McLachlan Properties Inc., (the Landlord).
WITNESSETH:
WHEREAS, Landlord and Tenant entered into a Lease Agreement dated October 1, 2004, and extended by First Amendment to Lease
dated October 8, 2009, extended by Second Amendment to Lease dated December 1, 2010, extended by Third Amendment to Lease dated
November 30th 2012, and extended by Fourth Amendment to Lease dated September 3rd 2013 herein collectively referred to as the "Lease"
for the property commonly known as 30 Worcester Road, Toronto, Ontario, M9W 5X2 consisting of approximately 25,000 square feet, the
("Leased Premises"); and
WHEREAS, the current term of the lease is to expire on November 30 th 2014.
WHEREAS, the Landlord and Tenant now desire to further extend the term and amend the Lease as set forth herein.
NOW THEREFORE, in consideration of the Recitals, all of which are incorporated by this reference, and other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, Landlord and Tenant hereby agree as follows:
1. Extended Term
The term of the Lease is hereby extended by a term of one (1) year commencing November 30, 2014 through November 30, 2015 (herein
referred to as the ("Extended Term").
2. Renewal
Provided that the Tenant is not in default of material provisions of the Lease, the Tenant may give notice to the Landlord not less than 6
months and not more than 9 months prior to the expiry of the Extended Term, to extend the term for a renewal period of 5 years at an
annual basic rent which may be the greater of (i) the amount of basic rent payable during the Extended Term, and (ii) the fair market rental
for the leased premises for the year prior to such renewal.
3. Early Termination of Lease
Provided that the Tenant is not in default of material provisions of the Lease, the Tenant shall have the option to exercise early termination
of the Extended Term upon submission by written notice by the Tenant to the Landlord of its intention to exercise this option.
4. Basic Rent
Yielding and paying unto the Landlord for the leased premises during the Extended Term, as basic rent, yearly and every year:
i.
During year the Extended Term, the annual sum of $89,588, payable $7,465.67 per month; plus applicable taxes.
5. Usual Terms
The parties agree that other terms shall be as in the lease now concluding, with appropriate changes, amendments and deletions as
necessary in the circumstances.
Executed at Toronto, Ontario this 28 th day of November, 2014
FINLEY W. McLACHLAN PROPERTIES INC.
/s/ Finley J. McLachlan
FINLEY J. McLACHLAN
INTELLIPHARMACEUTICS CORP.
/s/ John Allport
John Allport, Vice President Legal Affairs and Licensing
TO:
Intellipharmaceutics International Inc. (the "Company")
Extension of Debenture Maturity Date
RE:
Debenture dated January 1, 2013, for a face amount of US $1,500,000 issued by the Company to Isa Odidi and Amina Odidi (the
"Debenture") and the Maturity Date (as defined in the Debenture) of such Debenture
The undersigned hereby agree that the Maturity Date of the Debenture is extended from January 1, 2015, to July 1, 2015.
Exhibit 4.66
DATED as of October 1, 2014.
/s/ Isa Odidi
Isa Odidi
/s/ Amina Odidi
AminaOdidi
LIST OF SUBSIDIARIES
INTELLIPHARMACEUTICS INTERNATIONAL INC.
Exhibit 8.1
INTELLIPHARMACEUTICS INTERNATIONAL INC.
CERTIFICATION PURSUANT TO RULE 13a-14 OR 15d-14 OF
THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 12.1
I, Isa Odidi, certify that:
1. I have reviewed this Annual Report on Form 20-F of Intellipharmaceutics International Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to
make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period
covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
4. The company's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the company and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the company's disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and;
d) Disclosed in this report any change in the company's internal control over financial reporting that occurred during the period covered by
the annual report that has materially affected, or is reasonably likely to materially affect, the company's internal control over financial
reporting; and
5. The company's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the company's auditors and the audit committee of the company's board of directors (or persons performing the equivalent
functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the company's ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the company's internal
control over financial reporting.
Date: February 26, 2015
By:
/s/ Isa Odidi
Isa Odidi
Chairman of the Board and Chief Executive Officer
(Principal Executive Officer)
INTELLIPHARMACEUTICS INTERNATIONAL INC.
CERTIFICATION PURSUANT TO RULE 13a-14 OR 15d-14 OF
THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 12.2
I, Domenic Della Penna, certify that:
1. I have reviewed this Annual Report on Form 20-F of Intellipharmaceutics International Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to
make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period
covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
4. The company's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the company and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the company's disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and;
d) Disclosed in this report any change in the company's internal control over financial reporting that occurred during the period covered by
the annual report that has materially affected, or is reasonably likely to materially affect, the company's internal control over financial
reporting; and
5. The company's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the company's auditors and the audit committee of the company's board of directors (or persons performing the equivalent
functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the company's ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the company's internal
control over financial reporting.
Date: February 26, 2015
By:
/s/ Domenic Della Penna
Domenic Della Penna
Chief Financial Officer
(Principal Financial Officer)
INTELLIPHARMACEUTICS INTERNATIONAL INC.
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF
THE SARBANES-OXLEY ACT OF 2002
Exhibit 13.1
In connection with the Annual Report of Intellipharmaceutics International Inc. (the “Company”) on Form 20-F for the period
ending November 30, 2014 (the “Report”), I, Isa Odidi, the Chairman of the Board and Chief Executive Officer of the Company, certify,
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my
knowledge:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the
Company.
By: /s/ Isa Odidi
Isa Odidi
Chairman of the Board and Chief Executive Officer
(Principal Executive Officer)
Date: February 26, 2015
INTELLIPHARMACEUTICS INTERNATIONAL INC.
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF
THE SARBANES-OXLEY ACT OF 2002
Exhibit 13.2
In connection with the Annual Report of Intellipharmaceutics International Inc. (the “Company”) on Form 20-F for the period
ending November 30, 2014 (the “Report”), I, Domenic Della Penna, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the
Company.
By: _/s/ Domenic Della Penna
Domenic Della Penna
Chief Financial Officer
(Principal Financial Officer)
Date: February 26, 2015
Exhibit 15.1
Deloitte LLP
5140 Yonge Street
Suite 1700
Toronto ON, M2N 6L7
Canada
Tel: 416-601-6150
Fax: 416-601-6151
www.deloitte.ca
Consent of Independent Registered Public Accounting Firm
We consent to the incorporation by reference in Registration Statement No(s). 333-172796 and 333-196112 on Form F-3 of our report
dated February 23, 2015, relating to the consolidated financial statements of Intellipharmaceutics International Inc. (the “Company”)
(which report expresses an unmodified opinion and includes an emphasis of matter paragraph relating to the conditions and events that cast
substantial doubt on the Company’s ability to continue as a going concern) appearing in the annual report on Form 20-F for the year ended
November 30, 2014.
/s/ Deloitte LLP
Chartered Professional Accountants, Chartered Accountants
Licensed Public Accountants
February 26, 2015
Toronto, Canada