Linda P. OKeefe, Chief Financial Officer
(Name, Telephone, Email and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b) of the Act.
Securities registered or to be registered pursuant to Section 12(g) of the Act.
Securities for
which there is a reporting obligation pursuant to Section 15(d) of the Act.
Indicate the number of
outstanding shares of each of the issuers classes of capital or common stock as of the close of the period covered by the annual report.
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities
Act. Yes ☐ No ☒
If this report is an annual 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. Yes ☐ No ☒
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 ☐
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 ☐ 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):
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has
elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act ☐.
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
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.
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 ☒
Market data and certain industry data and forecasts included in this annual report were obtained from internal company surveys,
market research, publicly available information, reports of governmental agencies and industry publications and surveys. We have relied upon industry publications as our primary sources for third-party industry data and forecasts. Industry surveys,
publications and forecasts generally state that the information they contain has been obtained from sources believed to be reliable, but that the accuracy and completeness of that information is not guaranteed. We have not independently verified any
of the data from third-party sources or the underlying economic assumptions they made. Similarly, internal surveys, industry forecasts and market research, which we believe to be reliable based upon our managements knowledge of our industry,
have not been independently verified. Our estimates involve risks and uncertainties, including assumptions that may prove not to be accurate, and these estimates and certain industry data are subject to change based on various factors, including
those discussed under Risk Factors in this annual report. While we believe our internal business research is reliable and the market definitions we use in this annual report are appropriate, neither our business research nor the
definitions we use have been verified by any independent source. This annual report may only be used for the purpose for which it has been published.
We own or have rights to trademarks, service marks or trade names that we use in connection with the operation of our business.
In addition, our name, logo and website names and addresses are our service marks or trademarks. CaPre® and the phrase BREAKING DOWN THE WALLS OF CHOLESTEROL are our registered trademarks. The other trademarks, trade names and
service marks appearing in this annual report are the property of their respective owners. Solely for convenience, the trademarks, service marks, tradenames and copyrights referred to in this annual report are listed without the ©, ® and
TM
symbols, but we will assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensors to these trademarks, service marks and tradenames.
All
financial information in this annual report is presented in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB.
We use multiple financial measures for the review of our operating performance. These measures are generally IFRS financial
measures, but one adjusted financial measure,
Non-IFRS
operating loss (adding to net loss, finance expenses, depreciation and amortization and impairment loss, change in fair value of derivative warrant
liabilities, stock-based compensation and by subtracting finance income and deferred income tax recovery), is also used to assess our operating performance. This
non-IFRS
financial measure is derived from our
financial statements and is presented in a consistent manner. We use this measure, in addition to the IFRS financial measures, for the purposes of evaluating our historical and prospective financial performance, as well as our performance relative
to competitors. All of these measures also help us to plan and forecast future periods as well as to make operational and strategic decisions. We believe that providing this
Non-IFRS
information to investors,
in addition to IFRS measures, allows them to see our results through the eyes of our management, and to better understand our historical and future financial performance. See Item 5. Operating and Financial Review and Prospects,
including for a reconciliation to net loss.
In this annual report, all references to CA$ or $ are
to Canadian dollars, unless expressly otherwise stated. All amounts related to our financial results are presented in thousands of Canadian dollars, except where noted and per share amounts.
The following table presents the average exchange rate for one Canadian dollar expressed as one U.S. dollar for each of our
last five fiscal years. The average rate is calculated using the average of the exchange rates on the last day of each month during the period.
The following table presents the high and low exchange rate for one Canadian dollar expressed
as one U.S. dollar for each month during the previous six months.
The exchange rates are based upon the noon buying rate, as quoted by the Bank of Canada. As of
May 1, 2017, the Bank of Canada no longer publishes updated data for exchange rates published under previous methodologies, including daily noon and closing rates as well as high and low exchange rates. For the month of May 2017, the exchange
rate presented above is based upon the daily average closing rate. As of June 26, 2017, the exchange rate for one Canadian dollar expressed as one U.S. dollar, as quoted by the Bank of Canada was $1.00 = US$0.7554.
Although the forward-looking information in this annual report
is based upon what we believe are reasonable assumptions, you should not place undue reliance on that forward-looking information since actual results may vary materially from it. Important assumptions by us when making forward-looking statements
include, among other things, assumptions by us that:
In addition, the forward-looking information in this annual report is subject
to a number of known and unknown risks, uncertainties and other factors, including those described in this annual report under the heading Item 3.D. Risk Factors, many of which are beyond our control, that could cause our actual results
and developments to differ materially from those that are disclosed in or implied by the forward-looking information, including, among others:
All of the forward-looking information in this annual report is qualified by this
cautionary statement. There can be no guarantee that the results or developments that we anticipate will be realized or, even if substantially realized, that they will have the consequences or effects on our business, financial condition or results
of operations that we anticipate. As a result, you should not place undue reliance on the forward-looking information. Except as required by applicable law, we do not undertake to update or amend any forward-looking information, whether as a result
of new information, future events or otherwise. All forward-looking information is made as of the date of this annual report.
PART I
Item 1.
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Identity of Directors, Senior Management and Advisers
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Not applicable.
Item 2.
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Offer Statistics and Expected Timetable
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Not applicable.
A.
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Selected Financial Data
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The following information should be read
in conjunction with Item 5. Operating and Financial Review and Prospects and our audited financial statements and the related notes for our fiscal year ended March 31, 2017, which are prepared in accordance with IFRS as issued by
the IASB and are included in this annual report. The selected financial information below includes financial information derived from our audited financial statements. Our historical results from any prior period are not necessarily indicative of
results to be expected for any future period. The following table is a summary of our selected consolidated financial information in accordance with IFRS as issued by the IASB for each of our five most recently completed fiscal years.
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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For the fiscal year ended
|
|
|
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March 31, 2017
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|
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February 29, 2016
|
|
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February 28, 2015
|
|
|
February 28, 2014
|
|
|
February 28, 2013
|
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Revenue from sales
|
|
$
|
nil
|
|
|
$
|
nil
|
|
|
$
|
nil
|
|
|
$
|
501
|
|
|
$
|
724
|
|
Loss from operating activities
|
|
$
|
(11,210
|
)
|
|
$
|
(9,612
|
)
|
|
$
|
(12,395
|
)
|
|
$
|
(10,800
|
)
|
|
$
|
(6,980)
|
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Net loss and total comprehensive loss
|
|
$
|
(11,247
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)
|
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$
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(6,317
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)
|
|
$
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(1,655
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)
|
|
$
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(11,612
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)
|
|
$
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(6,892)
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Basic and diluted loss per share
|
|
$
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(1.01
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)
|
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$
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(0.59
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)
|
|
$
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(0.16
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)
|
|
$
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(1.38
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)
|
|
$
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(0.95)
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Total assets
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$
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25,456
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|
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$
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28,517
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|
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$
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37,208
|
|
|
$
|
45,632
|
|
|
$
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12,170
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Total liabilities
|
|
$
|
3,753
|
|
|
$
|
1,297
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|
|
$
|
3,980
|
|
|
$
|
12,352
|
|
|
$
|
2,446
|
|
Share capital
|
|
$
|
66,576
|
|
|
$
|
61,973
|
|
|
$
|
61,628
|
|
|
$
|
61,027
|
|
|
$
|
28,923
|
|
Warrants and rights
|
|
$
|
453
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
407
|
|
|
$
|
407
|
|
Weighted average number of shares outstanding
|
|
|
11,094,512
|
|
|
|
10,659,936
|
|
|
|
10,617,704
|
|
|
|
8,436,893
|
|
|
|
7,275,444
|
|
Dividends declared per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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B.
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Capitalization and Indebtedness
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Not applicable.
C.
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Reasons for the Offer and Use of Proceeds
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Not applicable.
8
Investing in our securities involves a high
degree of risk due to, among other things, the nature of our business and the present stage of our development. Prospective and current investors should carefully consider the following risks and uncertainties, together with all other information in
this annual report, as well as our financial statements included in this annual report and Item 5. Operating and Financial Review and Prospects. If any of these risks actually occur, our business, financial condition, prospects, results
of operations or cash flow could be materially and adversely affected and you could lose all or a part of the value of your investment. Additional risks or uncertainties not currently known to us, or that we currently deem immaterial, may also
negatively affect our business operations.
Risks Facing Our Business and Industry
We may not be able to maintain our operations and advance our research and development of CaPre without additional funding.
We have incurred operating losses and negative cash flows from operations since our inception. To date, we have financed our
operations through public offerings and private placements of securities, proceeds from exercises of warrants, rights and options, and receipt of research tax credits. Our cash and cash equivalents (including restricted investments) were
$9.8 million as of March 31, 2017 and $12.6
million as of February 29, 2016. We will require substantial additional funds to conduct further research and development and our planned Phase 3 program, obtain regulatory
approvals and commercialize CaPre. In addition to completing nonclinical and clinical trials, we expect that additional time and capital will be required by us to file an NDA to obtain FDA approval for CaPre in the United States and to complete
marketing and other
pre-commercialization
activities. We will also most likely require additional capital to fund our daily operating needs. To achieve our business plan, we will need to raise the necessary
capital primarily through additional securities offerings and strategic alliances. We have no committed source of additional capital from our parent company, Neptune Technologies and Bioressources Inc., or Neptune, which owns approximately 34% of
our common shares, or any other party, and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue our development or commercialization of CaPre
or our other research and development initiatives. Funding needs could also force us to seek strategic partners for CaPre at an earlier stage than we desire or on terms that are less favorable to us or force us to relinquish or license our rights to
CaPre on unfavorable terms or in markets where we would prefer to pursue development or commercialization ourselves. Additional funding from third parties may not be available on acceptable terms or at all to enable us to continue and complete our
research and development of CaPre.
Our financial statements have been prepared on a going-concern basis, which assumes we
will continue our operations in the foreseeable future and will be able to realize our assets and discharge our liabilities and commitments in the ordinary course of business. If we are unable to continue as a going concern, material writedowns to
the carrying value of our assets, including intangible assets, could be required. If we fail to obtain additional financing, we may not be able to continue as a going concern.
We may never become profitable or be able to sustain profitability.
We are a clinical-stage biopharmaceutical company with a limited operating history. The likelihood of success of our business
plan must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered when developing and expanding early-stage businesses and the regulatory and competitive environment in which we operate.
Biopharmaceutical product development is a highly speculative undertaking, involves a substantial degree of risk and is a capital-intensive business. We expect to incur expenses without any meaningful corresponding revenues unless and until we are
able to obtain regulatory approval and sell CaPre in significant quantities. We have been engaged in developing CaPre since 2008. To date, we have not generated any revenue from CaPre, and we may never be able to obtain regulatory approval for
marketing CaPre in any indication. Even we are able to commercialize CaPre, we may still not generate significant revenues or achieve profitability. We have incurred net losses of $11.2 million for the thirteen month period ended March 31,
2017, and $6.3 million and $1.7 million for our fiscal years ended 2016 and 2015, respectively. As of March 31, 2017, we had an accumulated deficit of $50.9 million.
If we obtain FDA approval for CaPre, we expect that our expenses will increase as we prepare for the commercial launch of
CaPre. We also expect that our research and development expenses will continue to increase if we pursue FDA approval for CaPre for other indications. As a result, we expect to continue to incur substantial
9
losses for the foreseeable future, and these losses may be increasing. We are uncertain about when or if we will be able to achieve or sustain profitability. If we fail to become and remain
profitable our ability to sustain our operations and to raise capital could be impaired and the price of our common shares could decline.
We have no marketing and sales organization and, as a company, no experience in marketing products. If we are unable to establish
marketing and sales capabilities or enter into agreements with a strategic partner to market and sell CaPre, we may not be able to generate revenue.
We have no sales, marketing or distribution capabilities and, as a company, we have no experience in marketing products. If
CaPre or another of our future product candidates is approved for commercialization, unless we find a strategic partner to assist us with sales, marketing and distribution, we will be required to develop
in-house
marketing and sales force capability, which would require significant capital expenditures, management resources and time. Also, we would have to compete with other biotechnology and pharmaceutical
companies to recruit, hire, train and retain marketing and sales personnel. We face competition in our search for strategic partners to assist us with sales, marketing and distribution, and we may not be able to establish or maintain any such
arrangements. If we do find a strategic partner, any revenue we receive from CaPre would partly depend upon the efforts of that strategic partner, which may not be successful. We may have little or no control over the marketing and sales efforts by
any strategic partner we find for CaPre and our revenue may be lower than if we had commercialized CaPre independently.
If we are
not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
Our ability to compete in the highly competitive pharmaceuticals industry largely depends upon our ability to attract and
retain highly qualified managerial, scientific and medical personnel. Competition for skilled personnel in our market is intense and competition for experienced scientists may limit our ability to hire and retain highly qualified personnel on
acceptable terms. We are highly dependent on our management, scientific and medical personnel. Despite our efforts to retain valuable employees, members of our management, scientific and medical teams may terminate their employment with us on short
notice or, potentially, without any notice at all. The loss of the services of any of our executive officers or other key employees could potentially harm our business, operating results or financial condition. Our success may also depend on our
ability to attract, retain and motivate highly skilled junior,
mid-level,
and senior managers and scientific personnel. In addition, we do not maintain key person insurance policies on the lives of
our executives or those of any of our other employees. Other pharmaceutical companies with which we compete for qualified personnel have greater financial and other resources, different risk profiles, and a longer history in the industry than we do.
They also may provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high-quality candidates than what we can offer. If we are unable to continue to attract and retain
high-quality personnel, the rate and success at which we can develop and commercialize CaPre and any other future product candidates would be limited.
Neptune has significant influence over matters we put to a vote of our shareholders.
Neptune currently owns approximately 34% of our outstanding common shares and we are a subsidiary of Neptune. As a result,
Neptune has significant influence with respect to all matters submitted to our shareholders for approval, such as the election and removal of directors, amendments to our articles of incorporation and
by-laws
and the approval of certain business combinations. This concentration of holdings may cause the market price of our common shares to decline, delay or prevent any acquisition, delay or discourage take-over attempts that shareholders may consider to
be favourable, or make it more difficult or impossible for a third party to acquire control of us or effect a change in our board of directors and management. Any delay or prevention of a change of control transaction could deter potential acquirors
or prevent the completion of a transaction in which our shareholders could receive a premium over the then current market price for our common shares.
Neptunes interests may not align with those of us or our other shareholders.
Neptunes interests may not in all cases be aligned with interests of us or our other shareholders. Neptune may have an
interest in pursuing acquisitions, divestitures and other transactions that may ultimately be detrimental to our business and negatively affect the market price of our common shares.
10
Business disruptions could seriously harm our future revenue and financial condition and
increase our costs and expenses.
Our operations, and those of our suppliers, third party manufacturers and other
contractors and consultants could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics and other natural or
man-made
disasters or business interruptions, for which we are predominantly self-insured. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase
our costs and expenses. We rely on third-party manufacturers to manufacture CaPre. Our ability to obtain supplies of CaPre could be disrupted if the operations of our manufacturers and suppliers are affected by a
man-made
or natural disaster or other business interruption.
Our prospects currently depend
entirely on the success of CaPre, which is still in clinical development, and we may not be able to generate revenues from CaPre.
We have no prescription drug products that have been reviewed or approved by the FDA, Health Canada or any similar regulatory
authority. Our only prescription drug candidate is CaPre, for which we have not yet filed an NDA, and for which we must conduct a Phase 3 program, undergo further development activities and seek and receive regulatory approval prior to commercial
launch, which we do not anticipate will occur until 2021 at the earliest. We have invested significant effort and financial resources in researching and developing CaPre. Further development of CaPre will require substantial investment, access to
sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from sales of CaPre, if it is ever approved for commercialization.
We do not have any other prescription drug candidates in development and so our business prospects currently depend entirely on
the successful development, regulatory approval and commercialization of CaPre, which may never occur. Most prescription drug candidates never reach the clinical development stage and even those that do reach clinical development have only a small
chance of successfully completing clinical development and gaining regulatory approval. If we are unable to successfully commercialize CaPre, we may never generate meaningful revenues. In addition, if CaPre reaches commercialization and there is low
market demand for CaPre or the market for CaPre develops less rapidly than we anticipate, we may not have the ability to shift our resources to the development of alternative products.
If we encounter difficulties enrolling patients in our planned Phase 3 program, our development activities for CaPre could be delayed or
otherwise adversely affected.
We may experience difficulties in patient enrollment in our clinical trials,
including our planned Phase 3 program for CaPre, for a variety of reasons. Timely completion of our clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain
in the trial until its conclusion. The enrollment of patients depends on many factors, including:
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|
|
the number of clinical trials for other product candidates in the same therapeutic area that are currently in
clinical development, and our ability to compete with those trials for patients and clinical trial sites;
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patient eligibility criteria defined in the protocol;
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|
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the size of the patient population;
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the risk that disease progression will result in death before the patient can enroll in clinical trials or
before the completion of any clinical trials in which the patient is enrolled;
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the proximity and availability of clinical trial sites for prospective patients;
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the design of the trial;
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our ability to recruit clinical trial investigators with the appropriate competencies and experience;
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our ability to obtain and maintain patient consents; and
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the risk that patients enrolled in clinical trials will drop out of the trials before completion.
|
Our planned Phase 3 program for CaPre may compete with other clinical trials for product candidates that
are in the same therapeutic areas as CaPre. This competition could reduce the number and types of patients and qualified clinical investigators available to us, because some patients who might have opted to enroll in our Phase 3 program may instead
opt to enroll in a trial being conducted by one of our competitors or a clinical trial site may not allow us to conduct our clinical program at that site if competing trials are already being conducted there. We may
11
also encounter difficulties finding adequate clinical trial sites at which to conduct our Phase 3 program. Delays in patient enrollment may result in increased costs or may affect the timing or
outcome of our planned Phase 3 program, which could impair or prevent its completion and adversely affect our ability to advance the development of CaPre.
We may not be able to obtain required regulatory approvals for CaPre.
We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including
approval by the FDA and, as a company, we have no experience in obtaining approval of any product candidates. The research, testing, manufacturing, labeling, packaging, storage, sale, marketing, pricing, export, import and distribution of
prescription drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries and those regulations differ from country to country. We are not permitted to market CaPre in the
United States until we receive approval of an NDA from the FDA and similar restrictions apply in other countries. In the United States, the FDA generally requires the completion of preclinical testing and clinical trials of each drug to establish
its safety and efficacy and extensive pharmaceutical development to ensure its quality before an NDA is approved. Regulatory authorities in other jurisdictions impose similar requirements. Of the large number of drugs in development, only a small
percentage result in the submission of an NDA to the FDA and even fewer are approved for commercialization. To date, we have not submitted an NDA for CaPre to the FDA or comparable applications to other regulatory authorities.
Our receipt of required regulatory approvals for CaPre is uncertain and subject to a number of risks, including:
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|
|
the FDA or comparable foreign regulatory authorities or independent institutional review boards, or IRBs, may
disagree with the design or implementation of our clinical trials;
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|
|
|
we may not be able to provide acceptable evidence of the safety and efficacy of CaPre;
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|
|
the results of our clinical trials may not meet the level of statistical or clinical significance required by
the FDA or other regulatory agencies for marketing approval;
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the dosing of CaPre in a particular clinical trial may not be at an optimal level;
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patients in our clinical trials may suffer adverse effects for reasons that may or may not be related to
CaPre;
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we may be unable to demonstrate that CaPres clinical and other benefits outweigh its safety risks;
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the data collected from our clinical trials may not be sufficient to support the submission of an NDA for
CaPre or to obtain regulatory approval for CaPre in the United States or elsewhere;
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the FDA or comparable foreign regulatory authorities may not approve the manufacturing processes or facilities
of third party manufacturers with which we contract for clinical and commercial supplies of CaPre; and
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|
|
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly
change in a manner rendering our clinical data insufficient for approval.
|
The FDA and other similar
regulators have substantial discretion in the approval process and may refuse to accept our application or may decide that our data is insufficient for approval and require additional clinical trials, or preclinical or other studies for CaPre. If
regulatory approval for CaPre is obtained in one jurisdiction, that does not necessarily mean that CaPre will receive regulatory approval in all jurisdictions in which we seek approval. If we fail to obtain approval for CaPre in one or more
jurisdictions, our ability to obtain approval in a different jurisdiction may be negatively affected.
Even if we receive regulatory
approval for CaPre, it may just be for a limited indication.
If we obtain regulatory approval for CaPre, we will
only be permitted to market it for the indication approved by the FDA, and any such approval may put limits on the indicated uses or promotional claims we may make for it, or otherwise not permit labeling that sufficiently differentiates CaPre from
competitive products with comparable therapeutic profiles. For example, while our initial objective is to seek regulatory approval for the treatment of severe HTG, afterwards obtaining approval for CaPre to address mild to moderate HTG could greatly
expand our potential market for CaPre. However, even if CaPre is approved for severe HTG, it may never be
12
approved for the treatment of mild to moderate HTG. In addition, any approval we receive for CaPre could contain significant use restrictions for specified age groups, warnings, precautions or
contraindications, or may be subject to burdensome post-approval study or risk management requirements. If any regulatory approval for CaPre contains significant limits, we may not be able to obtain sufficient funding or generate meaningful revenue
from CaPre or be able to continue developing, marketing or commercializing CaPre.
We may be unable to find successful strategic
partnerships to develop and commercialize CaPre.
We intend to seek
co-development,
licensing and/or marketing partnership opportunities with third parties that we believe will complement or augment our development and commercialization efforts for CaPre. Entering into
partnership relationships may require us to incur
non-recurring
and other charges, increase our near and long-term expenditures, issue securities that dilute our existing shareholders or disrupt our management
and business. Entering into partnership relationships could also delay the development of CaPre and our other future product candidates if we become dependent upon a strategic partner and that strategic partner does not prioritize the development of
CaPre relative to its other development activities. In addition, we face significant competition in seeking strategic partners and the negotiation process is time-consuming and complex. We may not be successful in our efforts to establish a
strategic partnership or other alternative arrangements for CaPre on our anticipated timeline, or at all, because CaPre may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view CaPre as
having the requisite potential to demonstrate safety and efficacy. Even if we do enter into strategic partnerships, those partnerships may not achieve our objectives.
We may be unable to develop alternative product candidates.
To date, we have not commercialized any prescription drug candidates and, other than CaPre, we do not have any compounds in
clinical trials, nonclinical testing, lead optimization or lead identification stages. If we fail to obtain regulatory approval for and successfully commercialize CaPre as a treatment for severe HTG or any other indication, whether as a stand-alone
therapy or in combination with other treatments, we would have to develop, acquire or license alternative product candidates or drug compounds to expand our product candidate pipeline beyond CaPre. In such a scenario, we may not be able to identify
and develop or acquire product candidates that prove to be successful products, or to develop or acquire them on terms that are acceptable to us.
We may not be able to compete effectively against our competitors pharmaceutical products.
The biotechnology and pharmaceutical industries are highly competitive. There are many pharmaceutical companies, biotechnology
companies, public and private universities and research organizations actively engaged in the research and development of products that may be similar to CaPre. It is probable that the number of companies seeking to develop products and therapies
similar to CaPre will increase. Many of these and other existing or potential competitors have substantially greater financial, technical and human resources than we do and may be better equipped to develop, manufacture and market products. These
companies may develop and introduce products and processes competitive with or superior to CaPre. In addition, other technologies or products may be developed that have an entirely different approach or means of accomplishing the intended purposes
of CaPre, which might render our technology and CaPre
non-competitive
or obsolete.
Our competitors in the United States and globally include large, well-established pharmaceutical companies, specialty
pharmaceutical sales and marketing companies, and specialized cardiovascular treatment companies. GlaxoSmithKline plc, which currently sells LOVAZA, a prescription-only OM3 fatty acid indicated for patients with severe HTG, was approved by FDA in
2004 and has been on the market in the United States since 2005. Multiple generic versions of LOVAZA are now available in the United States. Amarin launched its prescription-only OM3 drug VASCEPA in 2013, and reached a market share of approximately
20% by the end of 2015. In addition, EPANOVA
(OM3-carboxylic
acids) capsules, a free fatty acid form of OM3 (comprised of 55% EPA and 20% DHA), is
FDA-approved
for
patients with severe HTG. Omtryg, another OM3 fatty acid composition developed by Trygg Pharma AS, received FDA approval for severe HTG. Neither EPANOVA nor Omtryg have yet been commercially launched, but could launch at any time. Other large
companies with products competing indirectly with CaPre include AbbVie, Inc., which currently sells Tricor and Trilipix for the treatment of severe HTG, and Niaspan, which is primarily used to raise
HDL-C
but
is also used to lower TGs. Generic versions of Tricor, Trilipix and Niaspan are also now available in the United States. In addition, we are aware of a number of other pharmaceutical companies that are developing products that, if approved and
marketed, would compete with CaPre.
13
Even if it receives regulatory approval, CaPre may need to demonstrate compelling
comparative advantages in efficacy, convenience, tolerability and safety to be commercially successful. Other competitive factors, including generic drug competition, could force us to lower prices or could result in reduced sales of CaPre. In
addition, new products developed by others could emerge as competitors to CaPre. If we are not able to compete effectively against our current and future competitors, our business will not grow and our financial condition and operations will suffer.
CaPre could face competition from products for which no prescription is required.
If it receives regulatory approval, CaPre will be a prescription-only OM3. Mixtures of OM3 fatty acids are naturally occurring
substances in various foods, including fatty fish. OM3 fatty acids are also marketed by other companies as dietary supplements or natural health products. Dietary supplements may generally be marketed without a lengthy FDA premarket review and
approval process and do not require a prescription. However, unlike prescription drug products, manufacturers of dietary supplements may not make therapeutic claims for their products; dietary supplements may be marketed with claims describing how
the product affects the structure or function of the body without premarket approval, but may not expressly or implicitly represent that the dietary supplement will diagnose, cure, mitigate, treat, or prevent disease. We cannot be certain that
physicians or consumers will view CaPre as superior to these alternatives or that physicians will be more likely to prescribe CaPre. If the price of CaPre is significantly higher than the prices of commercially available OM3 fatty acids marketed by
other companies as dietary supplements or natural health products, physicians may recommend these commercial alternatives instead of CaPre or patients may elect on their own to take commercially available
non-prescription
OM3 fatty acids. Either of these outcomes could limit how we price CaPre and negatively affect our revenues.
If outcome studies being conducted by two of our competitors testing the impact of OM3 on treating patients with mild to moderate HTG are
negative, there could also be an adverse impact for CaPre.
We are currently awaiting outcome study data from two
of our competitors that are testing the effects of OM3 on patients with mild to moderate HTG. If those studies show that OM3 effectively treats patients with mild to moderate HTG, we believe that the potential to expand CaPres indication in
the future to include the treatment of moderate to high HTG would be significantly advanced. Conversely, if outcome study data from one or both of those competitors is negative, or if one or both clinical trials fail to be completed, our potential
target market for CaPre could be limited solely to patients with severe HTG and our ability to realize greater market potential of CaPre could be harmed.
Recent and future legal developments could make it more difficult and costly for us to obtain regulatory approvals for CaPre and
negatively affect the prices we may charge.
In the United States and elsewhere, recent and proposed legal and
regulatory changes to healthcare systems could prevent or delay our receipt of regulatory approval for CaPre, restrict or regulate our post-approval marketing activities, and adversely affect our ability to profitably sell CaPre. Proposals have also
been made to expand post-approval requirements and to restrict sales and promotional activities for pharmaceutical products. We do not know whether additional legislative changes will be enacted, or whether the FDAs regulations, guidance or
interpretations will be changed, or what impact any such changes will have, if any, on our ability to obtain regulatory approvals for CaPre. Further, the Centers for Medicare and Medicaid Services, or CMS, frequently changes product descriptors,
coverage policies, product and service codes, payment methodologies and reimbursement values. Also, increased scrutiny by the U.S. Congress of the FDAs approval process could significantly delay or prevent our receipt of regulatory approval
for CaPre and subject us to more stringent product labeling and post-marketing testing and other requirements.
In the
United States, the Medicare Modernization Act, or the MMA, changed the way Medicare covers and pays for pharmaceutical products. The MMA expanded Medicare coverage for drug purchases by the elderly and introduced a new reimbursement methodology
based on average sales prices for drugs. In addition, the MMA authorized Medicare Part D prescription drug plans to use formularies where they can limit the number of drugs that will be covered in any therapeutic class. As a result of the MMA and
the expansion of federal coverage of drug products, we expect there will be additional pressure to contain and reduce healthcare costs. These healthcare cost reduction initiatives and other provisions of the MMA could decrease the coverage and price
that we would receive for CaPre. While the MMA applies only to drug benefits for Medicare beneficiaries, private health insurance companies often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates, and
any reduction in reimbursement that results from the MMA may result in a similar reduction in payments from private health insurance companies.
14
The Patient Protection and Affordable Care Act, as amended by the Health Care and
Education Affordability Reconciliation Act (the Health Care Reform Law), has broadened access to health insurance, reduced or constrained the growth of healthcare spending, enhanced remedies against fraud and abuse, added new transparency
requirements for the healthcare and health insurance industries, imposed new taxes and fees on the health industry and imposed additional health policy reforms. Provisions of the Health Care Reform Law affecting pharmaceutical companies include
requirements to offer discounts on brand-name drugs to patients who fall within the Medicare Part D coverage gap, commonly referred to as the donut hole, and to pay an annual
non-tax
deductible fee
to the federal government based on each companys market share of prior year total sales of branded products to certain federal healthcare programs, such as Medicare, Medicaid, Department of Veterans Affairs and Department of Defense.
Despite initiatives to invalidate the Health Care Reform Law, the U.S. Supreme Court has upheld key aspects of it. Due to the
results of the recent presidential election, the Health Care Reform Law may be significantly changed and we do not know whether any such changes could have significant negative financial impact on the development or potential profitability of CaPre.
At this time, it remains unclear whether there will be any changes made to the Health Care Reform Law, whether to certain provisions or its entirety. The Health Care Reform Law or any replacement of it could continue to apply downward pressure on
pharmaceutical pricing, especially under the Medicare program, and may also increase our regulatory burdens and operating costs. Additional federal healthcare reform measures could be adopted in the future limiting the amounts that federal and state
governments will pay for healthcare products and services, which could negatively affect the value of CaPre and our ability to achieve profitability.
In Canada, most new patented drug prices are limited so that the cost of therapy is in the range of the cost of therapy for
existing drugs sold in Canada used to treat the same disease. As a result:
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prices of moderate and substantial improvement drugs and breakthrough drugs are also restricted by a variety
of tests;
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existing patented drug prices cannot increase by more than the Canadian Consumer Price Index; and
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the Canadian prices of patented medicines can never be the highest in the world.
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If CaPre receives regulatory approval in Canada, restrictions on the price we can charge there for CaPre could reduce the value of CaPre and
our ability to generate revenue and achieve profitability.
In many jurisdictions outside the United States, a product
candidate must be approved for health care reimbursement before it can be approved for sale. In some cases, the price that we intend to charge for CaPre will also be subject to approval. If we fail to comply with the regulatory requirements in our
target international markets or to receive required marketing approvals, our potential market for CaPre will be reduced and our ability to realize the full market potential for CaPre will be harmed.
Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance. If there is not sufficient
reimbursement for CaPre, it is less likely that it will be widely used.
Even if CaPre is approved for sale by the
appropriate regulatory authorities, market acceptance and sales of CaPre will depend on reimbursement policies and may be affected by future healthcare reform measures. Government authorities and third-party payors, such as private health insurers
and health maintenance organizations, decide which drugs they will reimburse and establish payment levels. We cannot be certain that reimbursement will be available for CaPre. If reimbursement is not available or is available on a limited basis, we
may not be able to successfully commercialize CaPre.
There may be significant delays in obtaining coverage and
reimbursement for newly-approved drugs, and coverage may be more limited than the purposes for which the drug is approved by the FDA or other regulatory authorities. Moreover, eligibility for coverage and reimbursement does not imply that a drug
will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution expenses. Interim reimbursement levels for new drugs, if applicable, may also be insufficient to cover our costs
and may not be made permanent. Reimbursement rates may vary according to the use of a drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing
payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from
countries where they may be sold at lower prices than in the United States. Our inability to promptly obtain coverage and profitable payment rates from both government-funded and private payors for CaPre could have a material adverse effect on our
operating results and our overall financial condition.
15
Even if we obtain FDA approval of CaPre, we may never obtain approval or commercialize it
outside of the United States, which would limit our ability to realize CaPres full market potential.
In
order to market CaPre outside of the United States, we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy. Clinical trials conducted in one country may not be accepted by
regulatory authorities in other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval procedures vary among countries and can involve additional product testing and
validation and additional administrative review periods. Seeking foreign regulatory approvals could result in significant delays, difficulties and costs for us and may require additional preclinical studies or clinical trials, which would be costly
and time consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of CaPre in those countries. In addition, our failure to obtain regulatory approval in any country may delay or have
negative effects on the process for regulatory approval in other countries. If we fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, our target market will be reduced and our ability to
realize the full market potential of CaPre will be harmed.
If we or our third-party service providers fail to comply with healthcare
laws and regulations or government price reporting laws, we could be subject to civil or criminal penalties.
In
addition to the FDAs restrictions on marketing pharmaceutical products, several other types of federal and state healthcare fraud and abuse laws restrict marketing practices in the pharmaceutical industry. These laws include the U.S.
Anti-Kickback Statute, U.S. False Claims Act and similar state laws. The U.S. Anti-Kickback Statute prohibits, among other things, offering, paying, soliciting or receiving remuneration to induce, or in return for, purchasing, leasing, or ordering
any healthcare item or service reimbursable under Medicare, Medicaid or other federally financed healthcare programs. A person or entity does not need to have actual knowledge of the U.S. Anti-Kickback Statute or special intent to violate the law in
order to have committed a violation. This statute has been interpreted broadly to apply to arrangements between pharmaceutical manufacturers and prescribers, dispensers, purchasers and formulary managers. The exemptions and safe harbors from
prosecution are drawn narrowly and we may fail to meet all of the criteria for safe harbor protection from anti-kickback liability.
In addition, the Health Care Reform Law provides that the government may assert that a claim including items or services
resulting from a violation of the U.S. Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the U.S. False Claims Act. Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a
false claim for payment to the federal government or knowingly making, or causing to be made, a false statement to get a false claim paid. The qui tam provisions of the False Claims Act allow a private individual to bring civil actions
on behalf of the federal government alleging that the defendant has submitted a false claim to the federal government. These individuals, sometimes known as relators or, more commonly, as whistleblowers, may share in any
amounts paid by the entity to the government in fines or settlement. The number of filings of qui tam actions has increased significantly in recent years, causing more healthcare companies to have to defend a case brought under the federal False
Claim Act. If an entity is determined to have violated the federal False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus attorneys fees and costs, and civil penalties of up to
US$21,563 for each separate false claim. Certain administrative sanctions, up to and including exclusion of an entity from participation in the federal healthcare programs, may also ensue.
Additional laws and regulations include:
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the U.S. federal Health Insurance Portability and Accountability Act (HIPAA), as amended by the Health
Information Technology for Economic and Clinical Health Act (HITECH), which created additional federal criminal statutes that prohibit, among other things, schemes to defraud healthcare programs and imposes requirements on certain types of people
and entities relating to the privacy, security, and transmission of individually identifiable health information, and requires notification to affected individuals and regulatory authorities of breaches of security of individually identifiable
health information;
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the federal Physician Payment Sunshine Act, which requires certain manufacturers of drugs, devices, biologics
and medical supplies for which payment is available under Medicare, Medicaid, or the Childrens Health Insurance Program, to report annually to the CMS information related to payments and other transfers of value to physicians, other healthcare
providers and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate family members, which is published in a searchable form on an annual basis; and
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the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws, which generally prohibit
companies and their intermediaries from making improper payments to government officials for the purpose of obtaining or retaining business. Violations of these laws, or allegations of such violations, could result in fines, penalties or prosecution
and have a negative impact on our business, results of operations and reputation.
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Over the past few
years, a number of pharmaceutical and other healthcare companies have been prosecuted under these laws for a variety of alleged prohibited promotional and marketing activities, such as providing free trips, free goods, sham consulting fees and
grants and other monetary benefits to prescribers; reporting to pricing services inflated average wholesale prices that were then used by federal programs to set reimbursement rates; engaging in
off-label
promotion that caused claims to be submitted to Medicaid for
non-covered,
off-label
uses; and submitting inflated best price information to the Medicaid Rebate Program
to reduce liability for Medicaid rebates. Most states also have statutes or regulations similar to the U.S. Anti-Kickback Statute and the U.S. False Claims Act, which apply to items and services reimbursed under Medicaid and other state programs,
or, in several states, apply regardless of the payor. Sanctions under these federal and state laws may include civil monetary penalties, exclusion of a manufacturers products from reimbursement under government programs, criminal fines and
imprisonment. Settlements of U.S. government litigation may include Corporate Integrity Agreements with commitments for monitoring, training, and reporting designed to prevent future violations.
Any action against us for an alleged or suspected violation of these laws could cause us to incur significant legal expenses
and could divert our managements attention from the operation of our business, even if our defense is successful. In addition, achieving and sustaining compliance with these laws and regulations may be costly to us in terms of money, time and
resources. If we or any strategic partners, manufacturers or service providers fail to comply with these laws, we could be subject to enforcement actions, including:
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adverse regulatory inspection findings;
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voluntary or mandatory product recalls or public notification or medical product safety alerts to healthcare
professionals;
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restrictions on, or prohibitions against, marketing our products;
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restrictions on, or prohibitions against, importation or exportation of our products;
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suspension of review or refusal to approve pending applications or supplements to approved applications;
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exclusion from participation in government-funded healthcare programs;
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exclusion from eligibility for the award of government contracts for our products;
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suspension or withdrawal of product approvals;
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civil and criminal penalties and fines.
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We rely on third parties to conduct our clinical trials for CaPre.
We rely heavily on contract research organizations, or CROs, to monitor and manage data for our preclinical studies and
clinical trials for CaPre. While we only control certain aspects of the CROs activities, we nevertheless are responsible for ensuring that our clinical trials are conducted in accordance with applicable protocols, legal, regulatory and
scientific standards, and our reliance on the CRO does not relieve us from those responsibilities. We and the CRO are required to comply with cGCPs, which are regulations and guidelines enforced by the FDA, Health Canada and comparable foreign
regulatory authorities for any products in clinical development.
17
The FDA enforces these cGCP regulations through periodic inspections of trial sponsors, principal investigators and trial sites. If we or the CRO fail to comply with applicable cGCPs, the
clinical data generated in our clinical trials may be deemed unreliable and the FDA, Health Canada or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications for
CaPre. Upon inspection, the FDA could determine that our clinical trials do not comply with cGCPs. In addition, our clinical trials must be conducted with products produced under cGMP regulations and require a large number of test subjects. If we or
the CRO fail to comply with these regulations, we may have to repeat preclinical studies or clinical trials for CaPre, which would delay the regulatory approval process and could also subject us to enforcement action up to and including civil and
criminal penalties.
If our relationship with a CRO terminates, we may not be able to enter into arrangements with
alternative CROs. If the CRO does not successfully carry out its duties or obligations or meet expected deadlines, if it needs to be replaced or if the quality or accuracy of the clinical data it obtains is compromised due to the failure to adhere
to our clinical protocols, regulatory requirements or for other reasons, we may have to extend, delay or terminate our preclinical studies or clinical trials, and we may not be able to obtain regulatory approval for or successfully commercialize
CaPre.
The third parties conducting our preclinical studies and clinical trials at CROs will not be our employees and,
except for remedies available to us under our agreements with the CROs, we cannot control whether or not they devote sufficient time and resources to our preclinical, clinical and nonclinical programs. These third parties may also have relationships
with other commercial entities, including our competitors, for whom they may also be conducting clinical studies or other drug development activities, which could affect their performance on our behalf.
We rely on third parties to manufacture, produce and supply CaPre and we may be adversely affected if those third parties are unable or
unwilling to fulfill their obligations, including complying with FDA requirements.
Producing pharmaceutical
products requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. We do not own or operate manufacturing facilities for the production of CaPre, nor do we have plans
to develop our own manufacturing operations in the foreseeable future. Accordingly, we need to rely on one or more third party manufacturers to produce and supply our required drug product for our nonclinical research and clinical trials for CaPre.
Although we are currently working with CordenPharma at its Chenôve facility in Dijon, France to develop a
commercially viable manufacturing process for CaPre, doing so is a difficult and uncertain task, and there are risks associated with scaling to the level required for advanced clinical trials or commercialization, including, among others, cost
overruns, potential problems with process scale up, process reproducibility, stability issues, lot consistency and timely availability of reagents or raw materials. Any of these challenges could delay completion of our preclinical studies or
clinical trials for CaPre, require bridging or repetition of studies or trials, increase development costs, delay approval of CaPre, impair our commercialization efforts, and increase our costs. We may have to delay or suspend the production of
CaPre if a third-party manufacturer:
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becomes unavailable for any reason, including as a result of the failure to comply with current good
manufacturing practices, or cGMP, regulations;
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experiences manufacturing problems or other operational failures, such as equipment failures or unplanned
facility shutdowns required to comply with cGMP or damage from any event, including fire, flood, earthquake, business restructuring or insolvency; or
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fails or refuses to perform its contractual obligations under its agreement with us, such as failing or
refusing to deliver the quantities of CaPre requested by us on a timely basis.
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If our third-party
manufacturers fail to achieve and maintain high manufacturing standards in compliance with cGMP regulations, we may be subject to sanctions, including fines, product recalls or seizures, injunctions, delays or suspensions of our clinical trials for
CaPre, total or partial suspension of production of CaPre, civil penalties, withdrawals of previously granted regulatory approvals, and criminal prosecution. We do not currently have arrangements in place for redundant supply. If any one of our
current contract manufacturers cannot perform as agreed, we may be required to replace that manufacturer. Although we believe that there are several potential alternative manufacturers who could manufacture CaPre, we may incur added costs and delays
in identifying and qualifying any such replacement.
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The research, development and manufacture of CaPre involves using potentially hazardous
materials.
Our research and development activities relating to CaPre involve the controlled use of potentially
hazardous substances, including chemical and biological materials. Our manufacturers for CaPre will be subject to federal, provincial, state and local laws and regulations in Canada, the United States and in other jurisdictions governing laboratory
procedures and the use, manufacture, storage, handling and disposal of medical and hazardous materials. Although we believe that our manufacturers procedures for using, handling, storing and disposing of these materials comply with legally
prescribed standards, we cannot completely eliminate the risk of contamination or injury resulting from medical or hazardous materials. If any such contamination or injury were to occur, we may incur liability or local, city, provincial, state or
federal authorities may curtail the use of these materials and interrupt our business operations and the production of CaPre. In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed
our resources. We do not have any insurance for liabilities arising from medical or hazardous materials. Complying with environmental, health and safety laws and regulations is expensive, and current or future environmental regulations may impair
our research, development and production efforts relating to CaPre, which could harm our business, prospects, financial condition or results of operations. Although we maintain workers compensation insurance to cover us for costs and expenses
we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort
claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials. In addition, we may incur substantial costs in order to comply with current or future environmental, health and
safety laws and regulations. These laws and regulations may make it more difficult for us to conduct our research, development or production activities relating to CaPre and if we fail to comply with them, we could have substantial fines, penalties
or other sanctions imposed against us.
We depend on Neptune for some important services.
Neptune provides us with some shared back office services and functions, including corporate affairs, public company reporting,
accounting, payroll, information technology, accounts payable, accounts receivable and shared premises. If our arrangements with Neptune for these services were to be terminated or not renewed, we may have to incur additional costs to provide them
ourselves or to source them from another third party.
We rely on Neptune to supply us with the krill oil we need to produce CaPre
for our clinical programs and commercial supply.
We depend on krill oil sourced from Neptune to produce CaPre. If
we are not able to acquire krill oil in sufficient quantities from Neptune, we may need to seek alternative suppliers of krill oil and may be required to pay higher prices. Any alternative supply of krill oil may not be of comparable quality to that
provided by Neptune, which could negatively affect the efficacy, or the markets perception of the efficacy, of CaPre. Our reliance on Neptune or other third-party suppliers for krill oil exposes us to risks such as potential fluctuations in
supply and reduced control over our production costs and delivery schedules for CaPre.
Interruptions of our supply of CaPre could
disrupt our planned Phase 3 program and, if CaPre reaches commercialization, impair any future revenue streams.
We
will require much larger amounts of CaPre for purposes of our planned Phase 3 program and potential commercialization than we have in the past. Supply interruptions for CaPre could occur and our inventory of CaPre may not always be sufficient due to
a number of factors, including:
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failure to have a third-party supply chain partners process validated in a timely manner;
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shortages of required raw materials, such as krill oil, and the packaging components required by our manufacturers;
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changes in our sources for manufacturing or packaging;
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failure to timely locate and obtain replacement manufacturers, as needed; and
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conditions affecting the cost and availability of raw materials.
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We are also
in the process of
scaling-up
our production of CaPre and CaPre may not be of comparable quality when produced in large 100 kilogram batches. If we experience interruptions in the production of CaPre, our
ability to complete our planned Phase 3 program could be interrupted. If CaPre receives regulatory approval, interruptions in the production of CaPre or insufficient inventory levels of CaPre could have a material adverse effect on our results of
operations.
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If product liability lawsuits are brought against us, we may incur substantial liabilities
and be required to cease the sale, marketing and distribution of CaPre.
We face a potential risk of product
liability associated with any future commercialization of CaPre or any other future product candidate we develop. For example, we may be sued if CaPre allegedly causes injury. Any such product liability claims may include allegations of defects in
manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability and a breach of warranties. Claims could also be asserted under U.S. state or Canadian provincial or other foreign consumer
protection legislation. If we cannot successfully defend against product liability claims, we may incur substantial liabilities or be required to cease the sale, marketing and distribution of CaPre. Even successful defense against product liability
claims would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:
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decreased demand for CaPre or any future products that we may develop;
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injury to our reputation;
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costs to defend the related litigation;
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a diversion of managements time and our resources;
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substantial monetary awards to consumers, trial participants or patients;
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product recalls, withdrawals or labeling, marketing or promotional restrictions;
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an inability to commercialize CaPre; and
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a decline in the price of our common shares.
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If we are unable to obtain and
retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims, the commercialization of CaPre or any other product candidates we develop could be hindered or prevented. We currently carry
product liability insurance, shared with Neptune, in the amount of $10.0 million in the aggregate.
Any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in
part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. In the event of a successful
product liability claim against us, we may have to pay from our own resources any amounts awarded by a court or negotiated in a settlement that exceed coverage limitations or that is not covered by our insurance, and we may not have, or be able to
obtain, sufficient funds to pay such amounts.
We may not achieve our publicly announced milestones on time, or at all.
From time to time, we may publicly announce the timing of certain events we expect to occur, such as the anticipated timing of
results from our clinical trials. These statements are forward-looking and are based on the best estimate of management at the time relating to the occurrence of the events. However, the actual timing of these events may differ from what has been
publicly disclosed. The timing of events such as completion of a clinical trial, discovery of a new product candidate, filing of an application to obtain regulatory approval, beginning of commercialization of products, or announcement of additional
clinical trials for a product candidate may ultimately vary from what is publicly disclosed. For example, we cannot provide assurances that we will conduct our planned Phase 3 clinical trial for CaPre, that we will make regulatory submissions or
receive regulatory approvals as planned, or that we will be able to adhere to plans for the
scale-up
of manufacturing and launch of CaPre. These variations in timing may occur as a result of different events,
including the nature of the results obtained during a clinical trial or during a research phase, problems with a supplier or a distribution partner or any other event having the effect of delaying the publicly announced timeline. We undertake no
obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as otherwise required by law. Any variation in the timing of previously-announced milestones could have a
material adverse effect on our business, financial condition or operating results and the trading price of our common shares.
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We may be subject to foreign exchange rate fluctuations.
Our reporting currency is the Canadian dollar. However, many of our expenses, such as CaPres chief manufacturing
organizations production activities and certain CRO arrangements for our planned Phase 3 program, currently are and/or are expected to be, denominated in foreign currencies, including European euros and U.S. dollars. Though we plan to
implement measures designed to reduce our foreign exchange rate exposure, the U.S. dollar/Canadian dollar and European euro/Canadian dollar exchange rates have fluctuated significantly in the recent past and may continue to do so, which could have a
material adverse effect on our business, financial position and results of operations.
Risks Related to Intellectual Property
It is difficult and costly to protect our intellectual property rights.
The success of our business will largely depend on our ability to:
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obtain and maintain patents, trade secret protection and operate without infringing the intellectual
proprietary rights of third parties;
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successfully defend our patents, including patents licensed to us by Neptune, against third-party challenges;
and
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successfully enforce our patents against third party competitors.
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Our patents and/or proprietary technologies could be circumvented through the adoption of competitive, though
non-infringing,
processes or products. The patent positions of pharmaceutical companies can be highly uncertain and involve complex legal, scientific and factual questions for which important legal principles remain
unresolved. Changes in either the patent laws or in interpretations of patent laws may diminish the value of our intellectual property. We cannot predict the breadth of claims that may be allowable or enforceable in our patents, including the
patents licensed to us by Neptune.
We face risks that:
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our rights under our Canadian, U.S. or foreign patents or other patents that Neptune or other third parties
license to us could be curtailed;
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we may not be the first inventor of inventions covered by our issued patents or pending applications or be the
first to file patent applications for those inventions;
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our pending or future patent applications may not be issued with the breadth of claim coverage sought by us,
or be issued at all;
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our competitors could independently develop or patent technologies that are substantially equivalent or
superior to our technologies;
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our trade secrets could be learned independently by our competitors;
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the steps we take to protect our intellectual property may not be adequate; and
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effective patent, trademark, copyright and trade secret protection may be unavailable, limited or not sought
by us in some foreign countries.
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Further, patents have a limited lifespan. In the United States, a
patent generally expires 20 years after it is filed (or 20 years after the filing date of the first
non-provisional
U.S. patent application to which it claims priority). While extensions may be available, the
life of a patent, and the protection it affords, is limited. Without patent protection for CaPre or any other of our future product candidates, we may be open to competition from generic versions of CaPre or our other future product candidates.
Further, the extensive period of time between patent filing and regulatory approval for a product candidate limits the time during which we can market that product candidate under patent protection. Patents owned by third parties could have priority
over patent applications filed or
in-licensed
by us, or we or our licensors could become involved in interference, opposition or invalidity proceedings before U.S., Canadian or foreign patent offices. The cost
of defending and enforcing our patent rights against infringement charges by other patent holders may be significant and could limit our operations.
21
CaPre is partly covered by patents that are not owned by us but are instead licensed to us
by Neptune.
In addition to our proprietary patent applications, we have an exclusive worldwide license under a
license agreement with Neptune to use certain patents and
know-how
owned by Neptune to develop and commercialize CaPre within a specified field of use. This limitation on our field of use may prevent us from
developing and commercializing CaPre in other fields. Also, our license from Neptune is subject to termination for breach of its terms, and therefore our license rights are only available to us for as long as Neptune agrees that our development and
commercialization activities meet the terms of the license.
Disputes may arise between us and Neptune regarding the intellectual property
that is subject to the license agreement, including with respect to:
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the scope of rights granted under the license agreement and other interpretation-related issues;
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whether and the extent to which our technology and processes infringe on intellectual property of Neptune that
is not subject to the licensing agreement;
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our right to sublicense patent and other rights to third parties under collaborative development
relationships;
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our diligence obligations with respect to our use of the licensed technology in relation to our development
and commercialization of our product candidates, and what activities satisfy those diligence obligations; and
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the ownership of inventions and
know-how
resulting from the joint
creation or use of intellectual property by Neptune and us and our partners.
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If our license is
terminated for any reason and we are not able to negotiate another agreement with Neptune for use of its patents and
know-how,
we would not be able to manufacture and market CaPre, which would have a material
adverse effect on our business and financial condition.
CaPre may infringe the intellectual property rights of others, which could
increase our costs and delay or prevent our development and commercialization efforts.
Our success depends in part
on avoiding infringement of the proprietary technologies of others. The pharmaceutical industry has been characterized by frequent litigation regarding patent and other intellectual property rights. Identification of third party patent rights that
may be relevant to our proprietary or licensed technology is difficult because patent searching is imperfect due to differences in terminology among patents, incomplete databases and the difficulty in assessing the meaning of patent claims.
Additionally, because patent applications are maintained in secrecy until the application is published, we may be unaware of third-party patents that may be infringed by our development and commercialization of CaPre or any other future product
candidate. There may be certain issued patents and patent applications claiming subject matter that we may be required to license in order to research, develop or commercialize CaPre, and any such patents and patent applications may not be available
to license on commercially reasonable terms, or at all. If claims of patent infringement are asserted by third parties against us, they could be time-consuming and may:
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result in costly litigation;
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divert the time and attention of our technical personnel and management;
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delay our clinical trials for CaPre;
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prevent us from commercializing CaPre until the asserted patent expires or is held finally invalid or not infringed in court;
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require us to cease or to modify our use of the technology and/or develop
non-infringing
technology; or
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require us to enter into royalty or licensing agreements.
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Others may hold
proprietary rights that could prevent CaPre from being marketed. Any patent-related legal action against us claiming damages and seeking to enjoin commercial activities relating to CaPre or our processes could subject us to potential liability for
damages and require us to obtain a license to continue to manufacture or market CaPre or any other future prescription drug candidates. We might not prevail in any such actions or if any license is required under any of these patents it may not be
available on commercially acceptable terms, if at all.
22
Even if a license can be obtained on acceptable terms, the rights may be
non-exclusive,
which could give our competitors access to the same technology or
intellectual property rights licensed to us. We could be forced to redesign CaPre or any other future product candidates or processes to avoid infringement.
In addition, we may find it necessary to pursue claims or initiate lawsuits to protect or enforce our patent or other
intellectual property rights. The cost to us in defending or initiating any litigation or other proceeding relating to patent or other proprietary rights, even if resolved in our favor, could be substantial, and litigation would divert our
managements attention. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. Uncertainties resulting from the initiation and
continuation of patent litigation or other proceedings could delay our research and development efforts and limit our ability to continue our operations.
A number of companies, including several major pharmaceutical companies, have conducted research on pharmaceutical uses of OM3
fatty acids, which has resulted in the filing of many patent applications related to this research. We are aware of third-party U.S., Canadian or other foreign patents that contain broad claims related to methods of using these general types of
compounds, which may be construed to include potential uses of CaPre. If we were to challenge the validity of these or any other issued U.S., Canadian or other foreign patents in court, we would need to overcome a statutory presumption of validity
that attaches to every U.S. and Canadian patent. This means that, in order to prevail, we would have to present clear and convincing evidence as to the invalidity of the other partys patents claims. If we were to challenge the validity
of any issued U.S. patent in an administrative trial before the Patent Trial and Appeal Board in the United States Patent and Trademark Office, or USPTO, we would have to prove that the claims are unpatentable by a preponderance of the evidence. If
there are disputes over our intellectual property rights, a jury and/or court may not find in our favor on questions of infringement, validity or enforceability.
If we do not protect our trademark for CaPre, we may not be able to build name recognition in our markets of interest.
We have trademarked CaPre. Our trademark may be challenged, infringed, circumvented or declared generic or determined to be
infringing on other marks. We may not be able to protect our rights to this trademark or may be forced to stop using this name, which we need for name recognition by potential strategic partners and customers. If we are unable to establish name
recognition based on our trademark, we may not be able to compete effectively and our business may be adversely affected.
We may be
involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
Competitors may infringe our patents or the patents of our licensors. To counter infringement or unauthorized use, we may be
required to file infringement claims, which can be expensive and time-consuming. If we or our licensors were to initiate legal proceedings against a third party to enforce a patent covering CaPre or our technology, the defendant could counterclaim
that our or our licensors patent is invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged
failure to meet any of several statutory requirements; for example, lack of novelty, obviousness or
non-enablement.
Grounds for an unenforceability assertion could be an allegation that someone connected with
prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. The outcome following legal assertions of invalidity and unenforceability during patent litigation is unpredictable. With
respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we or our licensors and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of
invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on CaPre or certain aspects of our platform technology. Such a loss of patent protection could have a material adverse impact on our business.
Patents and other intellectual property rights also will not protect our technology if competitors design around our protected technology without legally infringing our patents or other intellectual property rights.
In addition, in an infringement proceeding, a court may refuse to stop the other party from using the technology at issue on
the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated, held unenforceable, or interpreted narrowly and could
put our patent applications at risk of not issuing. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.
23
Interference proceedings provoked by third parties or brought by the USPTO may be
necessary to determine the priority of inventions with respect to our patents or patent applications or those of our licensors. An unfavorable outcome could result in a loss of our current patent rights and could require us to cease using the
related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms, or at all. Litigation or interference proceedings
may result in a decision adverse to our interests and, even if we are successful, may result in substantial costs and distract our management and other employees. We may not be able to prevent, alone or with our licensors, misappropriation of our
trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as in the United States. Furthermore, because of the substantial amount of discovery required in connection with intellectual
property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim
proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common shares.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment
and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for
non-compliance
with these requirements.
Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect CaPre and any of our other
future product candidates.
Numerous recent changes to the patent laws and proposed changes to the rules of the
USPTO may have a significant impact on our ability to protect our technology and enforce our intellectual property rights. For example, the Leahy-Smith America Invents Act
,
or AIA, enacted in 2011, involves significant changes in patent
legislation. An important change introduced by the AIA is that, as of March 16, 2013, the United States transitioned to a
first-to-file
system for
deciding which party should be granted a patent when two or more patent applications are filed by different parties claiming the same invention. A third party that files a patent application in the USPTO after that date but before us could therefore
be awarded a patent covering an invention of ours even if we had made the invention before it was made by the third party. This will require us to be cognizant going forward of the time from invention to filing of a patent application. Further, the
Supreme Court of the United States has ruled on several patent cases in recent years, some of which cases either narrow the scope of patent protection available in certain circumstances or weaken the rights of patent owners in certain situations.
These changes have led to increasing uncertainty with regard to the scope and value of our issued patents and to our ability to obtain patents in the future.
Among some of the other changes introduced by the AIA are changes that limit where a patentee may file a patent infringement
suit and providing opportunities for third parties to challenge any issued patent in the USPTO. This applies to all of our U.S. patents, even those issued before March 16, 2013. Because of a lower evidentiary standard in USPTO proceedings
compared to the evidentiary standard in United States federal court necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same
evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first
challenged by the third party as a defendant in a district court action.
Once granted, patents may remain open to
opposition, interference,
re-examination,
post-grant review,
inter partes
review, nullification derivation and opposition proceedings in court or before patent offices or similar proceedings for a given
period after allowance or grant, during which time third parties can raise objections against the initial grant. In the course of any such proceedings, which may continue for a protracted period of time, the patent owner may be compelled to limit
the scope of the allowed or granted claims attacked, or may lose the allowed or granted claims altogether. Depending on decisions by the U.S. Congress, the U.S. federal courts, the USPTO or similar authorities in foreign jurisdictions, the laws and
regulations governing patents could change in unpredictable ways that may weaken our and our licensors ability to obtain new patents or to enforce existing patents we and our licensors or partners may obtain in the future.
We may not be able to protect our intellectual property rights throughout the world.
Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign
jurisdictions. The legal systems of some countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, which could make it difficult for us to stop the
infringement of our patents or marketing of competing products in violation of our
24
proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our
business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate
and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the
intellectual property that we develop or license.
Risks Relating to Our Common Shares
The trading price of our common shares may be volatile.
Market prices for securities in general, and those of pharmaceutical companies in particular, tend to fluctuate. The trading
price for our common shares has experienced volatility in the past. Factors that could affect the trading price of our common shares and cause volatility include, among others:
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results or delays of
pre-clinical
and clinical studies by us or others;
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the commencement, enrollment or results of future clinical trials we may conduct, or changes in the development status of CaPre or any of our other future product candidates;
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any delay in our regulatory filings for CaPre or any of our other future product candidates and any adverse development or perceived adverse development with respect to the applicable regulatory authoritys review
of our filings;
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filing or granting or invalidity of patents;
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exclusive rights obtained by us or others;
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disputes or other developments relating to proprietary rights, including patents;
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litigation matters and our ability to obtain patent protection for our technologies;
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changes in regulations;
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additions or departures of key scientific or management personnel;
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overall performance of the equity markets;
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general political and economic conditions;
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failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;
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research reports or positive or negative recommendations or withdrawal of research coverage by securities analysts;
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announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
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public concerns over the risks of pharmaceutical products and dietary supplements;
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unanticipated serious safety concerns related to the use of CaPre; and
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future sales of securities by us in financings or by our shareholders.
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As a
result, the market price of our common shares may fluctuate significantly in the future. In addition, the stock market in general, and pharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often
been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common shares, regardless of our actual operating performance. In the past,
securities class action litigation has often been instituted against companies following periods of volatility of the market price of a companys securities. This type of litigation, if brought against us, could result in substantial costs and
liabilities for us and divert our managements attention and resources, which would harm our business, operating results or financial condition.
25
Future securities issuances by us could result in significant dilution for existing
shareholders.
Our articles of incorporation permit us to issue an unlimited number of common shares and preferred
shares, issuable in series, and our shareholders will have no
pre-emptive
rights in connection with further issuances of securities by us. Our directors have the discretion to determine the provisions
attaching to any series of preferred shares and the price of issue of further issuances of our common shares. Also, additional common shares may be issued by us upon the exercise of outstanding stock options and warrants. The issuance of these
additional equity securities or the issuance of new stock options or warrants may have a dilutive effect on existing holders of our common shares and, as a result, the market price for our common shares could decline. The market price of our common
shares could also decline as a result of future issuances by us in connection with strategic partnerships, or sales by our existing shareholders, or the perception that these sales could occur. Sales by our shareholders, including Neptune, might
also make it more difficult for us to sell equity securities at a time and price that we deem appropriate, which could reduce our ability to raise capital and have an adverse effect on our business.
Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to
our technologies or product candidates.
We may seek additional capital through a combination of public and private
equity offerings, debt financings, strategic partnerships and alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our shareholders
will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our common shareholders. The incurrence of indebtedness would result in increased fixed payment obligations and could involve certain
restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our
business. If we raise additional funds through strategic partnerships and licensing arrangements with third parties, we may have to relinquish valuable rights relating to CaPre or our other future product candidates, or grant licenses on terms
unfavorable to us.
An active market for our common shares might not be sustained.
If an active market for our common shares is not sustained, holders of our common shares may be unable to sell their
investments on satisfactory terms. Declines in the value of our common shares may adversely affect the liquidity of the market for our common shares. Factors unrelated to our performance may also have an effect on the price and liquidity of our
common shares including:
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extent of analyst coverage of us;
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lower trading volume and general market interest in our common shares;
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the size of our public float; and
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any event resulting in a delisting of our common shares from the NASDAQ Stock Market or the TSX Venture Exchange, or TSXV.
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A large number of our common shares may be issued and subsequently sold upon the exercise of our outstanding warrants and under our
convertible debentures, which could depress the trading price for our common shares.
As of March 31, 2017, we
had up to 5,254,535 common shares issuable under our outstanding warrants and convertible debentures. To the extent that holders of our warrants and convertible debentures sell underlying common shares issued under those warrants and convertible
debentures, the market price of our common shares may decrease due to the additional selling pressure in the market and could encourage short sales by third parties. In a short sale, a prospective seller borrows common shares from a shareholder or
broker and sells the borrowed common shares. The prospective seller anticipates that the common share price will decline, at which time the seller can purchase common shares at a lower price for delivery back to the lender. The risk of dilution from
issuances of our common shares underlying our warrants and convertible debentures could also cause shareholders to sell their common shares, which could result in a decline in their market price.
We do not intend to pay dividends on our common shares for the foreseeable future.
We have never paid dividends on our common shares and we do not anticipate paying any dividends on our common shares for the
foreseeable future because, among other reasons, we currently intend to retain any future earnings to finance our business. Any future payment of dividends by us will depend on factors such as cash on hand
26
and whether we achieve profitability, our financial requirements to fund our growth, our general financial condition and other factors our board of directors may consider appropriate in the
circumstances. Until we pay dividends, which we may never do, our shareholders will not be able to receive a return on their common shares unless they sell them.
If we fail to meet applicable listing requirements, the NASDAQ Stock Market or the TSXV may delist our common shares from trading, in
which case the liquidity and market price of our common shares could decline.
Our common stock is currently listed
on the NASDAQ Stock Market and the TSXV, but we cannot assure you that our securities will continue to be listed on the NASDAQ Stock Market and the TSXV in the future. In the past, we have received notices from the NASDAQ Stock Market that we have
not been in compliance with its continued listing standards, and we have taken responsive actions and regained compliance. If we fail to comply with listing standards and the NASDAQ Stock Market or TSXV delists our common shares, we and our
shareholders could face significant material adverse consequences, including:
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a limited availability of market quotations for our common shares;
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reduced liquidity for our common shares;
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a determination that our common shares are penny stock, which would require brokers trading in our common shares to adhere to more stringent rules and possibly result in a reduced level of trading activity
in the secondary trading market for our common shares;
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a limited amount of news about us and analyst coverage of us; and
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a decreased ability for us to issue additional equity securities or obtain additional equity or debt financing in the future.
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We may pursue opportunities or transactions that adversely affect our business and financial condition.
In the ordinary course of our business, our management regularly explores potential strategic opportunities and transactions,
which may involve:
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significant debt or equity investments in us by third parties;
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the acquisition or disposition by us of material assets;
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the licensing, acquisition or disposition by us of material intellectual property;
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the development of new product lines or new applications for our existing products;
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entering into distribution arrangements;
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issuance of our common shares; and
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Public announcement by us of strategic opportunities or
transactions might have a significant effect on the trading price of our common shares. Our policy is to not publicly disclose our pursuit of a potential strategic opportunity or transaction unless we are required to do so by applicable law.
Investors who buy or sell our common shares could be doing so at a time when we are pursuing a particular strategic opportunity or transaction that, when announced, could have a significant effect on the trading price for our common shares.
In addition, any strategic transactions we enter into could carry significant risks, including:
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exposure to unknown liabilities;
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higher than anticipated transaction costs and expenses;
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the difficulty and expense of integrating operations and personnel of any acquired companies;
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disruption of our ongoing business;
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diversion of our managements time and attention; and
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possible dilution to our existing shareholders.
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As a foreign private issuer, we are subject to different U.S. securities laws and
regulations than a domestic U.S. issuer, which may limit the information publicly available to our U.S. shareholders.
We are a foreign private issuer under applicable U.S. federal securities laws, and therefore, we are not required to comply
with all the periodic disclosure and current reporting requirements of the U.S. Securities and Exchange Act of 1934, or the Exchange Act. As a result, we do not file the same reports that a U.S. domestic issuer would file with the SEC, although we
are required to file with or furnish to the SEC the continuous disclosure documents that we are required to file in Canada under Canadian securities laws. In addition, our officers, directors and principal shareholders are exempt from the reporting
and short-swing profit recovery provisions of Section 16 of the Exchange Act. Therefore, our shareholders may not know on as timely a basis when our officers, directors and principal shareholders purchase or sell common shares as the reporting
periods under the corresponding Canadian insider reporting requirements are longer. In addition, as a foreign private issuer, we are exempt from the proxy rules under the Exchange Act.
As an emerging growth company, we are exempt from the requirement to comply with the auditor attestation requirements of the
Sarbanes-Oxley Act.
We are an emerging growth company, as defined in the U.S. Jumpstart Our Business
Start-ups
Act, and we use the exemption provided to emerging growth companies from the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002. Therefore, our internal controls over
financial reporting will not receive the level of review provided by the process relating to the auditor attestation included in annual reports of issuers that are not using an exemption. In addition, we cannot predict if investors will find our
common shares less attractive because we rely on this exemption. If some investors find our common shares less attractive as a result, there may be a less active trading market for our common shares and trading price for our common shares may be
negatively affected.
U.S. investors may be unable to enforce certain judgments.
We are a company existing under the
Business Corporations Act
(Québec). Some of our directors and officers are
residents of Canada, and substantially all of our assets are located outside the United States. As a result, it may be difficult to effect service within the United States upon us or upon some of our directors and officers. Execution by U.S. courts
of any judgment obtained against us or any of our directors or officers in U.S. courts may be limited to assets located in the United States. It may also be difficult for holders of securities who reside in the United States to realize in the United
States upon judgments of U.S. courts predicated upon civil liability of us and our directors and executive officers under the U.S. federal securities laws. There may be doubt as to the enforceability in Canada against
non-U.S.
entities or their controlling persons, directors and officers who are not residents of the United States, in original actions or in actions for enforcement of judgments of U.S. courts, of liabilities
predicated solely upon U.S. federal or state securities laws.
Item 4.
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Information on the Company
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A.
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History and Development of the Company
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We were incorporated on February 1, 2002 under Part 1A of the
Companies Act
(Québec) under the name
9113-0310 Québec Inc. On February 14, 2011, the
Business Corporations Act
(Québec) came into effect and replaced the
Companies Act
(Québec). We are now governed by the
Business Corporations
Act
(Québec). On August 7, 2008, under a Certificate of Amendment, we changed our name to Acasti Pharma Inc., our share capital description, the provisions regarding restrictions on transfers of our securities and our
borrowing powers. On November 7, 2008, under a Certificate of Amendment, we changed the provisions regarding our borrowing powers. We became a reporting issuer in Québec on November 17, 2008.
Our head and registered office is located at 545 Promenade du Centropolis, Suite 100, Laval, Québec
H7T 0A3. We currently employ 15 full-time employees, with the majority working out of our headquarters in Laval and our laboratory in Sherbrooke, Québec. Our website address is http://www.acastipharma.com. We do not incorporate the
information on or accessible through our website into this annual report, and you should not consider any information on, or that can be accessed through, our website as part of this annual report.
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Intercorporate Relationships
We have no subsidiaries. As of the date of June 26, 2017, Neptune owns 5,064,694 of our common shares, representing 34.4% of
our issued and outstanding common shares.
We are a biopharmaceutical innovator focused
on the research, development and commercialization of prescription drugs using
omega-3,
or OM3, fatty acids derived from krill oil. OM3 fatty acids have extensive clinical evidence of safety and efficacy in
lowering triglycerides, or TGs, in patients with hypertriglyceridemia, or HTG. Our lead product candidate is CaPre, an OM3 phospholipid, which we are developing initially for the treatment of severe HTG, a condition characterized by abnormally high
levels of TGs in the bloodstream (over 500 mg/dL). Market research commissioned by us from DP Analytics suggests there is a significant unmet medical need for an effective, safe and well-absorbing OM3 therapeutic that demonstrates a positive impact
on the major blood lipids associated with cardiovascular disease risk. We believe that, if supported by our Phase 3 program that we plan to initiate during the second half of 2017, CaPre will address this unmet medical need. We also believe the
potential exists to expand CaPres initial indication to the mild to moderate HTG (200 499 mg/dL) segment, although at least one additional clinical trial will likely be required to expand CaPres indications to this segment. We may
seek to identify new potential indications for CaPre that may be appropriate for future studies and pipeline expansion. In addition, we may also seek to
in-license
other cardiometabolic drug candidates for
drug development and commercialization.
In four clinical trials conducted to date, we saw the following beneficial effects
with CaPre, and we are seeking to demonstrate similar safety and efficacy in our planned Phase 3 program:
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significant reduction of TGs and
non-high
density lipoprotein
cholesterol
(
non-HDL-C)
levels in the blood of patients with mild to severe HTG;
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no deleterious effect on
low-density
lipoprotein cholesterol
(LDL-C),
or bad cholesterol, with the potential to reduce
LDL-C;
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potential to increase high-density lipoprotein cholesterol
(HDL-C),
or
good cholesterol;
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good bioavailability (absorption by the body), even under fasting conditions;
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no significant food effect when taken with either
low-fat
or
high-fat
meals; and
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an overall safety profile similar to that demonstrated by currently marketed OM3s.
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Our Successful Phase 1 and Phase 2 Studies Helps Reduce Phase 3 Program Risk
About Hypertriglyceridemia
According to The American Heart Association Scientific Statement on Triglycerides and Cardiovascular Disease from 2011, TG
levels provide important information as a marker associated with the risk for heart disease and stroke, especially when an individual also has low levels of
HDL-C,
and elevated levels of
LDL-C.
HTG can be caused by both genetic and environmental factors, including obesity, sedentary lifestyle and high-calorie diets. HTG is also associated with comorbid conditions such as chronic renal failure,
pancreatitis, nephrotic syndrome and diabetes. Multiple epidemiological, clinical, genetic studies suggest that patients with elevated TG levels (greater
29
than or equal to 200 mg/dL) are at a greater risk of coronary artery disease, or CAD, and pancreatitis, a life-threatening condition, as compared to those with normal TG levels. The genes
regulating TGs and
LDL-C
are equally strong predictors of CAD, but
HDL-C
is not. Other studies suggest that lowering and managing TG levels may reduce these risks. In
addition, the Japan EPA Lipid Intervention Study, or JELIS, demonstrated the long-term benefit of an OM3 eicosapentaenoic acid, or EPA, in preventing major coronary events in hypercholesterolemic patients receiving statin treatment. JELIS found a
19% relative risk reduction in major coronary events in patients with relatively normal TGs but a more pronounced 53% reduction in the subgroup with TGs
³
150mg/dL and
HDL-C
< 40mg/dL.
About CaPre
CaPre is a krill
oil-derived
mixture containing polyunsaturated fatty acids, or PUFAs,
primarily composed of OM3 fatty acids, principally EPA, and docosahexaenoic acid, or DHA. EPA and DHA are well known to be beneficial for human health, and according to numerous recent clinical studies, may promote healthy heart, brain and visual
function, and may also contribute to reducing inflammation and blood TGs. Krill is a natural source of phospholipids and OM3 fatty acids. The EPA and DHA contained in CaPre are delivered as a combination of OM3s as free fatty acids and OM3s bound to
phospholipid esters, allowing these PUFAs to reach the small intestine where they undergo rapid absorption and transformation into complex fat molecules that are required for lipid transport in the bloodstream. We believe that EPA and DHA are more
efficiently transported by phospholipids sourced from krill oil than the EPA and DHA contained in fish oil that are transported either by TGs (as in dietary supplements) or as ethyl esters in other prescription OM3 drugs (such as LOVAZA and
VASCEPA), which must then undergo additional digestion before they are ready for transport into the bloodstream. The digestion and absorption of OM3 ethyl ester drugs requires a particular enzymatic process that is highly dependent on the fat meal
content the higher the fat content of the meal, the better the OM3 ethyl ester absorption. High fat meal content is not recommended in patients with HTG. We believe that CaPres superior absorption profile could represent a significant
clinical advantage, since taking it with a
low-fat
meal represents a more realistic and attractive regimen for patients with HTG who must follow a restricted
low-fat
diet.
CaPre is intended to be used as a therapy combined with positive lifestyle changes, such as a healthy diet, and to
be administered either alone or with other drug treatment regimens such as statins (a class of drug used to reduce
LDL-C).
CaPre is intended to be taken orally once or twice per day in capsule form.
Potential Market for CaPre
We believe a significant opportunity exists for OM3 market expansion because, among other things:
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cardiovascular diseases, or CVD, and stroke are the leading causes of morbidity and mortality in the United
States. The burden of CVD and stroke in terms of life-years lost, diminished quality of life, and direct and indirect medical costs also remains enormous;
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evidence suggests potential for OM3s in other cardiometabolic indications; and
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based on the assumption that the
REDUCE-IT
trial sponsored by Amarin
and the STRENGTH trial sponsored by Astra Zeneca, or the CV outcome trials, will be positive, key opinion leaders interviewed by DP Analytics in the study described further below estimated that they would increase their own prescribing of OM3s by
42% in mild to moderate HTG patients (200 499 mg/dL) and by 35% in severe HTG patients.
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30
According to the American Heart Association, the prevalence of HTG in the United
States and globally correlates to the aging of the population and the increasing incidence of obesity and diabetes. Market participants, including the American Heart Association, have estimated that
one-third
of adults in the United States have elevated levels of TGs (TGs
³
150 mg/dL), including approximately 36 million people diagnosed with mild to moderate HTG, and 3 to 4 million people diagnosed
with severe HTG. Moreover, according to Ford, Archives of Internal Medicine in a study conducted between 1999 and 2004, 18% of adults in the United States, corresponding to approximately 40 million people, had elevated TG levels equal to or
greater than 200 mg/dl, of which only 3.6% were treated specifically with
TG-lowering
medication. We believe this data indicates there is a large underserved market opportunity for CaPre.
In 2015, CaPres target market in the United States for severe HTG was estimated by IMS NSP Audit data to be approximately
$750 million, with approximately 5 million prescriptions written annually over the prior four years. The total global market was estimated by GOED Proprietary Research in 2015 to be approximately $2.3 billion. We believe there is the
potential to greatly expand the treatable market in the United States to the approximately 36 million people with mild to moderate HTG, assuming favorable results from the CV outcome studies that are currently ongoing. These CV outcome trials
are expected to report in
mid-2018
(the
REDUCE-IT
trial sponsored by Amarin) and 2019 (the STRENGTH trial sponsored by Astra Zeneca) and are designed to evaluate the
long-term benefit of lowering TGs on cardiovascular risks with prescription drugs containing OM3 fatty acids. If these trials are successful, additional clinical trials would likely be required for CaPre to also expand its label claims to the mild
to moderate HTG segment. Given the large portion of the adult population in the United States that have elevated levels of TGs but who go largely untreated, we believe there is the potential for a very significant increase in the total number of
patients eligible for treatment if the CV outcome trials are positive.
The following charts illustrate the estimated
global and U.S. markets for HTG in 2015, according to IMS NSP Audit data:
CaPre has two
FDA-approved
and marketed branded
competitors (LOVAZA and VASCEPA). In addition, Astra Zeneca has an
FDA-approved
product, EPANOVA, which has not yet been launched. LOVAZA generics became available on the U.S. market in 2013. In spite of
generic options, audited prescription data from IMS NSP Audit data suggests that over 50% of OM3 prescriptions are written for branded products (LOVAZA or VASCEPA). By 2015, there had been only an approximately 25% decline in total market value, in
spite of some generic switching that occurs at pharmacies. This stability of branded products is due in part to the fact that the pricing differential between branded and generic OM3 products is smaller than is typically the case between branded and
generic products in the pharmaceutical industry. Based on both primary market research with pharmacy benefit managers, or PBMs, and audited prescription reports, the average pricing of generics is currently approximately $160 per month, while
pricing for branded products averages $250 - $300 per month. Amarin has raised prices for VASCEPA annually since its launch in late 2013. PBMs offer Preferred Brand status (Tier 2 or Tier 3), without significant restrictions (i.e. no
prior authorization, step edits, or high
co-payments)
for these branded OM3s.
Except as otherwise indicated, all of the information that follows under this heading has been derived from secondary sources,
including audited U.S. prescribing data, and from a qualitative U.S. commercial and primary market research assessment conducted for us by DP Analytics, A Division of Destum Partners, Inc., or Destum, a market research firm, dated August 19,
2016, which we refer to as the Destum Market Research. In its market analysis for CaPre, Destum utilized secondary market data and reports and conducted primary qualitative market research with physicians and third-party payers, such as
PBMs. One-on-one
in-depth
phone interviews lasting on
31
average
30-60
minutes were conducted with 22 physicians and 5 PBMs, and key qualitative data was obtained by Destum on current clinical practice for
treating patients with HTG, and their perceptions of the current unmet medical need in treating patients with HTG. All interviews were conducted by the same individual at Destum and recorded to ensure consistency and collection of key data points.
Destum utilized OM3 prescription data from 2009 to 2015 to estimate the size of CaPres potential market. Based on its discussions with the PBMs, Destum also assumed CaPre would be viewed favorably by payers at launch (e.g., Tier 2 or 3,
depending on payer plan, which is comparable to LOVAZA and VASCEPA). Upon completing the screening questionnaire and being approved for inclusion in Destums study, key opinion leaders, or KOLs, and high volume prescribers, or HVPs, were
provided with a study questionnaire and were asked to comment on a target profile for a potential new OM3 Product X offering a trifecta of cardio-metabolic benefits similar to the potential efficacy and safety benefits
demonstrated by CaPre in our two Phase 1 pharmacokinetic studies and two Phase 2 clinical trials, which we refer to as the Target Product Profile. Respondents were told that the unidentified product was being prepared for a Phase 3 program designed
to confirm with statistical significance the products safety and efficacy in patients with severe HTG. The Target Product Profile was used by Destum strictly for market research analysis purposes and should not be construed as an indication of
future performance of CaPre and should not be read as an expectation or guarantee of future performance or results of CaPre, and will not necessarily be an accurate indication of whether or not such results will be achieved by CaPre in our planned
Phase 3 program. We subsequently retained Destum as our exclusive advisor and business development consultant to identify potential strategic partners for CaPre, under which Destum may be entitled to a success fee if a business arrangement or
transaction is consummated. Destums market research and its conclusions were substantially completed prior our entry into this agreement with Destum.
During the Destum Market Research, KOLs and HVPs interviewed by Destum were asked to assess the level of unmet medical need
associated with treating patients with severe HTG based on currently available treatment options. 91% of physicians interviewed by Destum indicated that they believe that the current unmet medical need for treating HTG was moderate to high. The
reasons identified by these physicians for their dissatisfaction with the currently available OM3s included insufficient lowering of TGs (principally relating to VASCEPA), negative
LDL-C
effects (principally
relating to LOVAZA), gastrointestinal side effects, and the fishy taste from fish
oil-derived
OM3s. Despite the availability of other drug classes to treat severe HTG, interviewed physicians indicated that
they would welcome the introduction of new and improved OM3 products, particularly if they can address these perceived deficiencies.
Interviewed physicians responded favorably in the Destum Market Research to the Target Product Profile. They indicated that
their weighted prescribing percentages of the Target Product Profile would increase by approximately 35% to 53% (with the range depending on the specific profile presented) in the severe HTG patient population within two years of the Target Product
Profiles approval. Approximately 60% of the interviewed physicians indicated that they would switch primarily due to the trifecta effect of the Target Product Profile on reducing TGs and
LDL-C
while elevating
HDL-C,
and the remaining 40% indicated they would switch primarily due to the Target Product Profiles effective reduction of TGs alone. In
connection with their responses, the interviewed physicians were instructed to assume the Target Product Profile and all currently available OM3 products were not subject to any reimbursement or coverage hurdles (e.g., all products were on an equal
health care coverage playing field). This assumption was supported by our interviews with leading PBMs in the United States.
We plan to conduct additional market research with KOLs, HVPs, primary care physicians and payers to further develop and refine
our understanding of the potential marketplace for CaPre.
Our Clinical Data
CaPre is being developed by us for the treatment of patients with severe HTG. In two Phase 2 clinical trials conducted by us in
Canada (our COLT and TRIFECTA trials), CaPre was found to be safe and well-tolerated at all doses tested, with no serious adverse events that were considered treatment-related. Among the reported adverse events with an occurrence of greater than 2%
of subjects and greater than placebo, only diarrhea had an incidence of 2.2%.
In both Phase 2 clinical trials, CaPre
significantly lowered TGs in patients with mild to severe HTG. Importantly, in these studies, CaPre also demonstrated no deleterious effect on
LDL-C
(unlike LOVAZA and EPANOVA, which have been shown to
significantly increase
LDL-C
in patients with severe HTG). Further, our Phase 2 data indicated that CaPre may actually reduce
LDL-C.
LDL-C
is undesirable because it accumulates in the walls of blood vessels, where it can cause blockages (atherosclerosis). In the Phase 2 trials, CaPre also reduced
non-HDL-C
(all cholesterol contained in the bloodstream except
HDL-C),
which is also considered to be a marker of
32
cardiovascular disease. The COLT trial data showed a mean increase of 7.7% in
HDL-C
with CaPre at 4 grams per day (p=0.07). Further studies in our planned
Phase 3 program are required to demonstrate CaPres statistical significance with
HDL-C.
We believe that these multiple potential cardiovascular benefits, if confirmed in our planned Phase 3 program, could be
significant differentiators for CaPre in the marketplace, as no currently approved OM3 drug has shown an ability to positively modulate these four major blood lipid categories (TGs,
non-HDL-C,
LDL-C
and
HDL-C)
in the treatment of severe HTG. We also believe that if
supported by additional clinical trials, CaPre has the potential to become the
best-in-class
OM3 compound for the treatment of mild to moderate HTG.
On September 14, 2016, we announced positive data from our completed comparative bioavailability study, or the Bridging
Study. The Bridging Study was an open-label, randomized,
four-way,
cross-over, bioavailability study comparing CaPre, given as a single dose of 4 grams in fasting and fed
(high-fat)
states, as compared to the
FDA-approved
HTG drug LOVAZA
(OM3-acid
ethyl esters) in 56 healthy volunteers. The protocol
was reviewed and approved by the FDA. The primary objective of the Bridging Study was to compare the bioavailability of CaPre to LOVAZA, each administered as a single 4 gram dose with a
high-fat
meal, which is
the condition under which administration of OM3 drugs will yield the highest levels of EPA and DHA in the blood, and therefore has the highest potential for toxicity. To allow us to rely on the long-term safety data of LOVAZA to support a 505(b)(2)
NDA for CaPre, our results had to show that the blood levels of EPA and DHA resulting from a single 4 gram dose of CaPre are not significantly higher than from a single 4 gram dose of LOVAZA under fed
(high-fat
meal) conditions. The Bridging Study met all of its objectives and demonstrated that the levels of EPA and DHA following administration of CaPre did not exceed corresponding levels following
administration of LOVAZA in subjects who were fed a
high-fat
meal. We expect that these results will support a claim by us that CaPre and LOVAZA have a comparable safety profile. Also, among subjects in a
fasting state, CaPre demonstrated better bioavailability than LOVAZA, as measured by significantly higher blood levels of EPA and DHA. Since most HTG patients must follow a restricted
low-fat
diet, we believe
that CaPres strong bioavailability profile could provide a more effective clinical solution for these patients.
We
summarized and submitted data from our Bridging Study to the FDA for review and discussed it with the FDA at an End of Phase 2 meeting during the first quarter of 2017. We also presented our Bridging Study data at the National Lipid Association
Conference in May 2017 and we plan to submit the data from our Bridging Study for peer review and publication.
The graph
below illustrates that the Bridging Study achieved all of its objectives:
Absorption of EPA and DHA as ethyl ester formulations in the currently available
prescription OM3 drugs derived from fish oil (such as LOVAZA and VASCEPA) require the breakdown of the ethyl esters by pancreatic enzymes (lipases) to be released into the blood. These particular enzymes are produced in response to the consumption
of
high-fat
content meals, leading to optimal absorption of EPA and DHA. As a result, these OM3 ethyl ester formulations have demonstrated lower absorption and bioavailability when taken with a
low-fat
meal or on an empty stomach. As shown in our
CAP13-101
study described further below, absorption of CaPre, which is
33
formulated as OM3 phospholipids and free fatty acids, is not meaningfully affected by the fat content of a meal consumed prior to drug administration. Since a
low-fat
diet is typically a critical component for treatment of patients with severe HTG, we believe that being able to effectively combine CaPre with a
low-fat
diet
could give CaPre a significant clinical and marketing advantage over the ethyl ester-based OM3s, such as LOVAZA and VASCEPA, that must be taken with a
high-fat
meal to achieve optimal absorption.
Our
CAP13-101
study was an open-label, randomized, multiple-dose, single-center,
parallel-design study in healthy volunteers. 42 subjects were enrolled into 3 groups of 14 subjects who took 1 gram, 2 grams or 4 grams of CaPre, administered once a day 30 minutes after breakfast. The objectives of the study were to determine the
pharmacokinetic, or PK, profile and safety on Day 1 following a single oral dose and Day 14 following multiple oral doses of CaPre in individuals pursuing a
low-fat
diet (therapeutic lifestyle changes diet).
The effect of a
high-fat
meal on the bioavailability of CaPre was also evaluated at Day 15. Blood samples were collected for assessment of EPA and DHA total lipids in plasma to derive the PK parameters.
The PK profile of CaPre following multiple 4 gram doses obtained in the
CAP13-101
study
at Day 14 was compared to the results obtained in a similar PK study (Offman 2013 - ECLIPSE 2) where LOVAZA was also administered at 4 grams a day for 14 days with a
low-fat
diet. Although CaPre contains
approximately 2.5 times less EPA and DHA compared to LOVAZA (approximately 310 mg/1g capsule for CaPre versus 770 mg/1g capsule for LOVAZA), when administered with a
low-fat
meal, CaPre plasma levels of EPA
and DHA are very similar to those of LOVAZA, as indicated by the area under the plasma drug concentration against time curve, or AUC, and the maximal plasma drug concentration. This study gives us confidence in the dosing and design of our planned
Phase 3 program.
As illustrated by the two graphs below, CaPre reached similar blood and therapeutic levels to LOVAZA
after 14 daily doses of CaPre at 4 grams/day, despite CaPre containing 2.5 times less EPA and DHA compared to LOVAZA:
The graph below illustrates that the bioavailability of CaPre (total EPA+DHA levels in the
blood) does not appear to be meaningfully affected by the fat content of a meal after multiple daily doses of CaPre at 4 grams/day (< 20% difference in AUC).
We believe that
CaPres strong bioavailability could represent a
significant clinical advantage for CaPre since taking it with a
low-fat
meal represents a more realistic and attractive regimen for patients with HTG who must follow a restricted
low-fat
diet.
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Our Study
CAP13-101
CaPre Pharmacokinetics Shows No Significant Food
Effect
The graph below presents a summary of the effects of CaPre on patients lipid profiles
as obtained in our completed TRIFECTA and COLT Phase 2 clinical trials. 90% of the patients in these clinical trials had mild to moderate HTG (levels between 200 499 mg/dL) and 10% of patients had severe HTG (levels between 500 and 877
mg/dL), which was the maximum level of TGs permitted by Health Canadas study protocol. Only 30% of the participating patients were taking statins, which we believe is important because statins appear to enhance the
TG-lowering
effect of OM3s. In contrast, in our competitors summary data that follows, 100% of the patients in those studies with mild to moderate HTG were taking statins with their OM3s.
The summary data from our COLT and TRIFECTA clinical trials shows that CaPre significantly reduces TGs, but unlike some other
prescription
EPA/DHA-based
OM3s, it has no deleterious effect on
LDL-C
and may potentially increase
HDL-C
(p=0.07), which we
refer to as the trifecta effect. Also, a dose response was seen for all of the major lipid markers; the greater the dose of CaPre, the greater the beneficial effect of CaPre.
Our Phase 2 Study Results Show CaPre Dose Response and Potential for Trifecta Lipid Effect
* Indicates results reached statistical significance
TRIFECTA for 1g (N=130) & 2g (N=128) and COLT for 4g (N=62).
HDL-C
results at 4g from COLT
approached statistical significance at P=0.07.
We conducted a subgroup analysis including only patients with severe
HTG, consisting of approximately 10% of the patients from our TRIFECTA study, to compare the effects of CaPre versus other OM3 drugs in the initial target population of patients with severe HTG. Despite being given at a lower dose (only 1 gram and 2
grams), CaPres results compared very well with data from independent studies for the other prescription OM3 drugs that are
FDA-approved
for the treatment of severe HTG at higher doses of 2 grams and 4
grams. While the results of this subgroup analysis were not statistically significant for CaPre (potentially due to the small sample size), numerically, the results compared well with the other OM3 drugs, even though CaPre was given at a much lower
dose. The results for
LDL-C,
HDL-C
and
non-HDL-C
levels in the subgroup shown in the
table below are based on descriptive statistics only and are solely directional, meaning that no statistical testing was conducted and so no p values were generated.
35
Our
Sub-Group
Analysis in Patients with Severe HTG:
CaPre
1
at 1g and 2g Compares Well with Our Competitors
2
at 2g and 4g
Only ~1/3 of all patients across all studies were on statins
*
Indicates results reached statistical significance
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1.
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Subgroup analysis on CaPre Phase 2 TRIFECTA study data in patients with severe HTG; (N=10 for 1g & N=14 for 2g).
Results are not statistically significant for TGs, which may be explained by the small number of patients in this subgroup analysis. Results for
LDL-C,
HDL-C
and
non-HDL-C
are based on descriptive statistics only (no statistical testing conducted).
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2.
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LOVAZA 4g (N=103), VASCEPA 2g/4g (N=73/76), EPANOVA 2g/4g (N=100/99).
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Since statins appear to enhance the
TG-lowering
property of OM3 drugs, we conducted a subgroup analysis that only included patients who were taking a statin at baseline in the COLT and TRIFECTA studies (approximately 30% of the population of both trials, combined). The graph below compares the
TG-lowering
effects of CaPre to other OM3s, all on a background of a statin drug, and shows that CaPres
TG-lowering
effects compare well with other
FDA-approved
OM3 drugs. We believe it is noteworthy that only 39 patients on 2 grams of CaPre in our TRIFECTA study (out of a total of 128) and only 22 patients on 4 grams of CaPre in our COLT study (out of 62) were
taking statins.
The CaPre 2 gram bar graph in the table below shows the results from patients in our TRIFECTA trial who
were taking statins. A statistically significant reduction in TGs
(-25.7%
placebo corrected) was seen in that statin subgroup. The CaPre 4 gram bar graph in the table below shows patient results only from our
COLT trial (as there was no 4 gram component for our TRIFECTA). None of the results were statistically significant at 4 grams of CaPre, potentially due to the small number of patients (22) in the statins subgroup.
As seen in the larger full study analyses in the tables above, CaPre does not show any deleterious effect on LDL, and shows the
potential to decrease LDL and increase HDL (p=0.07). These observations will need to be confirmed in our planned Phase 3 program.
36
Our
Sub-Group
Analysis in Patients Treated with
Statins
1
vs Independent Competitor Data
2
: Potential for CaPre Trifecta Effect
*
Indicates results reached statistical significance
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1.
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CaPre subgroup analyses on patients treated with statins: TRIFECTA for 2g (N=39) and COLT for 4g (N=22). For CaPre 2g,
results for
LDL-C,
HDL-C,
and
non-HDL-C
are based on descriptive statistics only (no
statistical testing was conducted). For CaPre 4g, no results are statistically significant which may be explained by the small number of patients.
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2.
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All patients on a statin background: LOVAZA (N=122 for 4g), VASCEPA (N= 234 for 2g, N=227 for 4g), EPANOVA (N=209 for 2g,
N=207 for 4g). Statins have been shown to enhance the efficacy of OM3 products VASCEPA NDA 202057. Statistical review, section 4.2 Other special/Subgroup populations, p. 107; and Maki K et al. Clin. Ther. 2013.
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In summary, in addition to effectively reducing TG levels in patients with mild to severe
HTG, clinical data collected by us to date indicates that CaPre may also have:
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beneficial effects on other blood lipids, such as
HDL-C
(good
cholesterol) and
non-HDL-C;
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no deleterious effect on, and may potentially reduce,
LDL-C
(bad
cholesterol) levels; and
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absorption capability that is not meaningfully affected by the fat content of a meal consumed prior to drug
administration, providing patients with the reassurance that following their physician-recommended
low-fat
diet will still result in high absorption.
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We believe that these features could set CaPre apart from currently available
FDA-approved
OM3 treatment options in the marketplace and could give us a significant clinical and marketing advantage.
CaPres potential clinical benefits as compared to currently available
FDA-approved
OM3 treatment options are summarized in the table below and indicate that CaPre may deliver a more complete lipid management solution for patients with severe HTG:
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Our Nonclinical Research
In addition to our Phase 2 clinical trials, we carried out an extensive nonclinical program to demonstrate the safety of CaPre
in a defined set of studies required by the FDA. These studies were carried out by contract research organizations with Good Laboratory Practice certification and conducted on various species of animals recommended by the FDA to investigate the
long-term effects of CaPre at doses of up to 65 grams of human equivalent dose over 39 weeks. In these studies, hematological, biochemical, coagulation and overall health parameters of CaPre were evaluated and no toxic effects were observed in any
of the segments of the studies. Other studies focused on the potential toxic effects of CaPre on vital systems, such as the cardiovascular, respiratory and central nervous system as evaluated by behavioural studies of the various species. These
studies showed that CaPre did not have any adverse or toxic effects on any of the vital systems investigated, again up to doses well above the recommended clinical dose of CaPre. To rule out short term toxic effects of CaPre on genes, genomic
toxicity studies were undertaken on accepted cellular and animal models. These studies showed no toxic effects of CaPre on any of the genetic markers indicative of potential gene altering toxic effects.
We believe the studies conducted to date indicate that CaPre is well-tolerated and shows no toxic effects on any of the
physiological and vital systems of the tested animals or their genes or molecules at doses well above CaPres anticipated clinical therapeutic dose of 4 grams daily.
In parallel to our planned Phase 3 program, we will have to complete additional nonclinical studies, including a
pre-
and postnatal development study in rodents and a
26-week
oral carcinogenicity study in transgenic hemizygous rasH2 mice. These nonclinical studies will be required to
support a NDA for CaPre.
Our Planned Phase 3 Program Design
In March 2017, we announced our plans to proceed with our Phase 3 program following our
End-of-Phase
2 meeting with the FDA in February 2017. Based on the guidance we received from the FDA, we plan to conduct two pivotal, randomized, placebo-controlled Phase 3 studies to evaluate the safety and
efficacy of CaPre in patients with severe HTG (TG levels >500 mg/dL). These studies will evaluate CaPres ability to lower TGs from baseline in approximately 400 patients randomized to either 4 grams daily or placebo. The FDAs feedback
supports our plan to conduct two studies instead of one large study, potentially shortening the time to an NDA submission, as no open label extension to the studies is planned. We intend to initiate our Phase 3 program during the second half of
2017. The following chart illustrates the expected design and dosing of our planned Phase 3 program for CaPre.
38
Our Regulatory Strategy for CaPre
Our strategy is to develop and initially commercialize CaPre for the treatment of severe HTG. Our goal is to initiate our Phase
3 program during the second half of 2017, which would be specifically designed to fully evaluate the clinical effect of CaPre on TGs,
non-HDL-C,
LDL-C,
and
HDL-C
levels together with a variety of other cardiometabolic biomarkers in patients with severe HTG.
In December 2015, we announced that we intend to pursue a 505(b)(2) regulatory pathway towards an NDA approval in the United
States. A 505(b)(2) regulatory pathway is defined in the U.S. Federal Food Drug and Cosmetic Act (FDCA) as an NDA
containing investigations of safety and effectiveness that are being relied upon for approval and were not, in whole, conducted
by or
for the applicant, and for which the applicant has not obtained a right of reference. 505(b)(2) regulatory pathways differ from a
typical NDA because they allow a sponsor to rely, at least in part, on the FDAs findings of
safety and/or effectiveness for a previously-approved drug. We intend to pursue the 505(b)(2) regulatory pathway as a strategy to leverage the large body of safety data for LOVAZA, which could accelerate and streamline the development of CaPre and
reduce associated costs and risks.
In connection with our intended use of the 505(b)(2) pathway, the FDA supported our
proposal to conduct our Bridging Study that compared CaPre (which has an OM3 free fatty acid/phospholipid composition) with the
FDA-approved
HTG drug LOVAZA (which has an
OM3-acid
ethyl esters composition) in healthy volunteers. In February 2017, we met with the FDA to review our Bridging Study data. We confirmed with the FDA the 505(b)(2) regulatory approach to use the safety
data for LOVAZA, and finalized the study design for our Phase 3 clinical trials, which will be required for NDA approval.
We expect to continue our dialogue with the FDA during the second half of 2017 to obtain feedback on our regulatory and
clinical plans and to clarify or answer specific questions prior to our initiation of our Phase 3 clinical studies.
Our
planned key milestones and development timeline are presented below.
39
CaPre Development Timeline and Key Milestones
Our Intellectual Property Strategy
Under a license agreement we entered into with Neptune in August 2008, which we refer to as the license agreement,
we received an exclusive license to use Neptunes intellectual property portfolio related to cardiovascular pharmaceutical applications. The license agreement allows us to develop and commercialize CaPre and our novel and active pharmaceutical
ingredients, or APIs, for the prescription drug and medical food markets. As a result of a royalty prepayment transaction we entered into with Neptune on December 4, 2012, we are no longer required to pay any royalties to Neptune under the
license agreement during its term for the use of the licensed intellectual property. The license agreement expires on the date of the last to expire patent, which is 2031.
In addition to the license agreement, we continue to expand our own intellectual property, or IP, portfolio and patents. We
have now filed patent applications in 22 jurisdictions, including Europe, North America, Asia and Australia for our Concentrated Therapeutic Phospholipid Composition to treat HTG, and we currently have 17 issued or allowed patents and 17
patents pending. The last to expire of our patents is valid until 2031.
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Patent Description
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WO (PCT) Application # &
U.S. Patent #
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Expiration Date of
Patent Family
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Number of Patents
Worldwide
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Composition of Matter
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C
ONCENTRATED
T
HERAPEUTIC
P
HOSPHOLIPID
C
OMPOSITION
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WO2011050474 &
US8,586,567;
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2031*
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14*
(20 patents pending in
approx. 19 countries)
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* Five Australian innovation patents are valid until 2018, patent (ZL 201080059930.4) granted
by the Chinese Patent Office is valid until 2030 and patent (US 9475830) granted by the United States Patent and Trademark Office is valid until 2031. Our Australian patent AU 2010312238 expires in 2030.
U.S. patents were granted to us protecting a method of reducing serum TG levels comprising administering a composition
comprising about 66% phospholipid, or PL, (US 8,586,567), and a method of treating HTG comprising administering a composition comprising about 60% PL (US 9,475,830). We later filed a U.S. continuation patent application to pursue prosecution of
composition of matter claims encompassing an extract comprising a PL content between about 60% to about 99%. The U.S. patent covers concentrated therapeutic phospholipid compositions useful for treating or preventing diseases associated with
cardiovascular disease, metabolic syndrome, inflammation and associated diseases associated, neurodevelopmental diseases, and neurodegenerative diseases, comprising administering an effective amount of a concentrated therapeutic phospholipid
composition. The U.S. patent is valid until 2031. The corresponding US 8,586,567 patent has also been granted in South Africa and Japan. Chinese patent (ZL 201080059930.4), which is valid until 2030, relates to concentrated therapeutic phospholipid
OM3 compositions and covers methods for treating or preventing diseases associated with cardiovascular diseases, metabolic syndrome, inflammation, neurodevelopmental diseases, and neurodegenerative diseases. The patent had also been granted in
Japan, Mexico and Taiwan.
40
A patent is generally valid for 20 years from the date of first filing. Patent
terms can vary slightly for other jurisdictions, with 20 years from filing being the norm. In certain jurisdictions, exclusivity can be formally extended beyond the normal patent term to compensate for regulatory delays during the
pre-market
approval process.
We believe these patents increase potential commercial
opportunities for CaPre, including through possible licensing and partnership opportunities. We are committed to building a global portfolio of patents to ensure long-lasting and comprehensive intellectual property protection and to safeguard
potentially valuable market expansion opportunities.
Our patent No. 600167 in New Zealand, which is enforceable until
2030 and relates to a concentrated phospholipid composition comprising 60% PL and method of using the same for treating cardiovascular diseases, has been opposed by
BIO-MER
Ltd. Our corresponding Australian
patent No. 2010312238 was opposed by Enzymotec Ltd., but that opposition has been since been dropped. The New Zealand patent opposition is in its early stages. In our view, no new prior art has been presented that was not already considered in
other jurisdictions, such as in the United States and Japan, where our patents are in force.
The following table
summarizes the patent applications related to our license agreement with Neptune.
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Patent Description
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US Patent #
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Expiration Date of
Patent
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Holder
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Composition of Matter
(
NATURAL
PHOSPHOLIPIDS
OF
MARINE
ORIGIN
CONTAINING
FLAVONOIDS
AND
POLYUNSATURATED
PHOSPHOLIPIDS
AND
THEIR
USES
)
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US8,030,348
(1)
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2022
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Neptune
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Method of Use for Dyslipidemia
(
KRILL
AND
/
OR
MARINE
EXTRACTS
FOR
PREVENTION
AND
/
OR
TREATMENT
OF
CARDIOVASCULAR
DISEASES
,
ARTHRITIS
,
SKIN
CANCER
,
PREMENSTRUAL
SYNDROME
,
DIABETES
AND
TRANSDERMAL
TRANSPORT
)
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US8,057,825
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2022
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Neptune
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Method of Extraction
(M
ETHOD
OF
EXTRACTING
LIPIDS
FROM
MARINCE
AND
AQUATIC
ANIMAL
TISSUE
)
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US6,800,299
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|
2019
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Neptune
|
(1)
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Three continuations also stem from U.S. Pat. 8,030,348 (U.S. Pat. 8,278,351; and 8,383,675).
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We have applied for trademark protection of CaPre, and we are the owner of the trademark BREAKING DOWN THE WALLS OF CHOLESTEROL
in Canada, the United States and the European Union. The trademark CaPre® is registered in the United States, Canada, Australia, China, Japan and Europe. In addition, we also protect our optimization and extraction processes through industrial
trade secrets and
know-how.
Manufacturing of CaPre
We are developing CaPre as a NCE and we plan to implement our Phase 3 program using good manufacturing practices, or cGMP, good
clinical practices, or cGCP, and good laboratory practices, or cGLP. The contract manufacturing organizations, or CMOs, selected by us for manufacturing and packaging are all cGMP compliant. As batch sizes of 10 to 12 kilograms of CaPre have already
been successfully produced and tested clinically, we are now scaling up to 100 kg/day to fulfill the clinical product requirements for our planned Phase 3 program and initial commercial launch.
In preparation for our planned Phase 3 program, working together with our pharmaceutical CMOs, we have advanced the
installation and qualification of the proprietary extraction and purification equipment used to manufacture CaPre. We ran our first engineered production run of CaPre in December 2016 and our first scaled cGMP batches of CaPre at CordenPharmas
Chenôve facility in Dijon, France during the first half of 2017.
The graphic below illustrates the manufacturing
sequence for CaPre:
41
Our Business and Commercialization Strategy
Key elements of our business and commercialization strategy include initially obtaining regulatory approval for CaPre in the
United States for severe HTG. We do not have
in-house
sales and marketing capabilities. We are currently evaluating several alternative approaches to commercializing CaPre in the United States. Our preferred
strategy is to commercialize CaPre outside the United States through strategic partnerships, and to potentially seek funding support from strategic partnerships for these development and commercialization activities. We believe that a late
development-stage and differentiated drug candidate like CaPre could be attractive to various global, regional or specialty pharmaceutical companies, and we are taking an opportunistic approach to partnering and licensing in various geographies and
indications.
If we reach commercialization of CaPre, as part of our sales and marketing strategy, we expect to focus our
U.S. launch initially on lipid specialists, cardiologists and primary care physicians who comprise the top prescribers of lipid-regulating therapies for patients with severe HTG.
Our key commercialization goals include:
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initiating and completing our planned Phase 3 program and, assuming the results are positive, filing an
NDA to obtain regulatory approval for CaPre in the United States, initially for the treatment of severe HTG, with the potential to afterwards expand CaPres indication to the treatment of mild to moderate HTG;
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continuing to strengthen our patent portfolio and other intellectual property rights;
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continuing to evaluate the optimal strategic approach for commercializing CaPre in the United States; and
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pursuing strategic opportunities outside of the United States, such as licensing or similar transactions,
joint ventures, partnerships, strategic alliances or alternative financing transactions, to provide development capital, market access and other strategic sources of capital for us.
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In addition to completing our planned Phase 3 program, we expect that additional time and capital will be required to complete
the filing of an NDA to obtain FDA
pre-market
approval for CaPre in the United States, and to complete business development collaborations, marketing and other
pre-commercialization
activities before reaching the commercial launch of CaPre.
Competition
The biotechnology and pharmaceutical industries are highly competitive. There are many pharmaceutical companies, biotechnology
companies, public and private universities and research organizations actively engaged in the research and development of products that may be similar to CaPre. We believe that the number of companies seeking to develop products and therapies
similar to CaPre will likely increase, particularly if the CV outcome trials by Amarin and/or Astra Zeneca are successful.
42
Our competitors in the United States and globally include large, well-established
pharmaceutical companies, specialty pharmaceutical sales and marketing companies, and specialized cardiovascular treatment companies. GlaxoSmithKline plc, which currently sells LOVAZA, a prescription-only OM3 fatty acid indicated for patients with
severe HTG, was approved by the FDA in 2004 and has been available in the U.S. market since 2005. Multiple generic versions of LOVAZA are now available in the United States. Amarin launched its prescription-only OM3 drug VASCEPA in 2013, and reached
a market share of approximately 20% by the end of 2015. In addition, EPANOVA
(OM3-carboxylic
acids) capsules, a free fatty acid form of OM3 (comprised of 55% EPA and 20% DHA), is
FDA-approved
for patients with severe HTG. Omtryg, another
OM3-acid
fatty acid composition developed by Trygg Pharma AS, received FDA approval for severe HTG. Neither
EPANOVA nor Omtryg have yet been commercially launched, but could launch at any time. Other large companies with products that would compete indirectly with CaPre include AbbVie, Inc., which currently sells Tricor and Trilipix for the treatment of
severe HTG, and Niaspan, which is primarily used to raise
HDL-C
but is also used to lower TGs. Generic versions of Tricor, Trilipix, and Niaspan are also now available in the United States. In addition, we are
aware of a number of other pharmaceutical companies that are developing products that, if approved and marketed, would compete with CaPre.
Raw Materials
We use semi-refined raw krill oil as our primary raw material to produce CaPre. Krill is generally harvested in Antarctic
waters. The total quantity of the krill species is estimated to be at least 500,000,000 metric tons. The krill biomass is the worlds most abundant biomass and is monitored to help ensure sustainable cultivation. Currently, we source all of our
krill oil from Neptune.
Employees, Specialized Skills and Knowledge
Our management consists of professionals from business development, sales and marketing, clinical development, pharmaceutical
manufacturing, finance and science backgrounds. Our research team includes scientists with expertise in pharmaceutical development, chemistry, manufacturing and controls, nonclinical and clinical studies, pharmacology, regulatory affairs, quality
assurance/quality control, intellectual property and strategic alliances. As of March 31, 2017, we employed 15 people in Canada and the United States, eight of whom have advanced biology, engineering, chemistry, biochemistry or microbiology
degrees. We generally require all of our employees to enter into invention assignment,
non-disclosure
and
non-compete
agreements. We rely, in part, on some
administrative and general accounting support from Neptune, and we also rely on third-party consultants from time to time. Our employees are not covered by any collective bargaining agreement or represented by a trade union.
Additional Information About Our Phase 2 Clinical Trials
Our COLT Trial
Our COLT clinical trial, which was completed in 2014, was a randomized, open-label, dose-ranging, multi-center trial in Canada
designed to assess the safety and efficacy of CaPre in the treatment of patients with TG levels between
200-877
mg/dL. The primary objectives of the COLT study were to evaluate the safety and efficacy of 0.5
grams, 1 gram, 2 grams and 4 grams of CaPre per day in reducing fasting plasma TGs over 4 and 8 weeks, as compared to the standard of care alone.
The secondary objectives of the COLT study were to evaluate:
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the effect of CaPre on fasting plasma TGs in patients with TGs between
200-499
mg/dL (mild to moderate HTG);
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the dose dependent effect on fasting plasma triglycerides in patients with TGs between
500-877
mg/dL (severe HTG); and
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the effect of CaPre on fasting plasma levels of
LDL-C
(direct
measurement),
HDL-C,
non-HDL-C,
hs-CRP
and OM3 index.
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The final results of the COLT trial indicated that CaPre was safe and effective in reducing TGs in patients with mild to severe
HTG with significant mean (average) TG reductions above 20% after 8 weeks of treatment with daily doses of 4 grams and 2 grams. Demographics and baseline characteristics of the patient population were balanced in terms of age, race and gender. A
total of 288 patients were enrolled and randomized and 270 patients completed the study, which exceeded our targeted number of evaluable patients. From this patient population, approximately 90% had mild to moderate HTG.
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The proportion of patients treated with CaPre that experienced one or more
adverse events in the COLT trial was similar to that of the standard of care group (30.0% versus 34.5%, respectively). A substantial majority of adverse events were mild (82.3%) and no severe treatment-related adverse effects were reported. Only one
patient was discontinued from the study due to an adverse event of moderate intensity. While the rate of gastrointestinal side effects was higher in the CaPre groups compared to standard of care alone and appeared to increase in a dose-related
manner, none of the subjects participating in the study suffered from a serious adverse event. The COLT study results showed that even at higher doses, CaPre is safe and well tolerated with only transient and predominantly mild adverse events
occurring at low rates.
The COLT trial met its primary objective of showing CaPre to be safe and effective in reducing TGs
in patients with mild to severe HTG. After only a
4-week
treatment, CaPre achieved a statistically significant TG reduction as compared to standard of care alone. Standard of care could be any treatment
physicians considered appropriate in a real-life clinical setting and included lifestyle modifications as well as statins and/or ezetimibe. Patients treated with 4 grams of CaPre per day over 4 weeks reached a mean TG decrease of 15.4% from baseline
and a mean improvement of 18.0% over the standard of care. Results also showed increased benefits after 8 weeks of treatment, with patients on a daily dose of 4 grams of CaPre registering a mean TG decrease of 21.6% from baseline and a mean
improvement of 14.4% over the standard of care.
After 8 weeks of treatment, patients treated with 1 gram of CaPre for the
first 4 weeks of treatment and 2 grams for the following 4 weeks, showed a statistically significant TG mean improvement of 16.2% over the standard of care, corresponding to a 23.3% reduction for the
1-2
grams
patient population as compared to a 7.1% reduction for the standard of care. After 8 weeks of treatment, patients treated with 2 grams of CaPre for the entire 8 weeks showed statistically significant TG mean improvements of 14.8% over the standard
of care, corresponding to a 22.0% reduction for the 2 grams as compared to a 7.1% reduction for the standard of care. Also, after 8 weeks of treatment, patients treated with 4 grams for the entire 8 weeks showed statistically significant TG,
non-HDL-C
and HbA1
C
mean improvements of 14.4% and 9.8% and 15.0%, respectively, as compared to standard of care. The 4
grams group showed mean improvements in:
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TGs of 14.4%, corresponding to a reduction of 21.6% as compared to a reduction of a 7.1% for the standard of care group,
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non-HDL-C
of 9.8%, corresponding to a reduction of 12.0% as compared to a reduction of 2.3% for the standard of care group, and
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HbA1
C
of 15.0%, corresponding to a reduction of 3.5% as compared to an increase of 11.5% for the standard of care group.
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In addition, all combined doses of CaPre showed a statistically significant treatment effect on
HDL-C
levels, with an increase of 7.4% as compared to standard of care. Trends
(p-value
< 0.1) were also noted on patients treated with 4 grams of CaPre for the
entire
8-week
treatment period with mean reduction of total cholesterol of 7.0% and increase of
HDL-C
levels of 7.7%, as compared to the standard of care. The results of
the COLT trial indicated that CaPre has no significant deleterious effect on
LDL-C
(bad cholesterol) levels.
Our TRIFECTA Trial
Our TRIFECTA clinical trial, which was completed in 2015, was a
12-week,
randomized,
placebo-controlled, double-blind, dose-ranging trial in Canada, designed to assess the safety and efficacy of CaPre at a dose of 1 gram or 2 grams on fasting plasma TGs as compared to a placebo in patients with TG levels between
200-877
mg/dL. A total of 387 patients were randomized and 365 patients completed the
12-week
study, consistent with our targeted number of evaluable patients. From this
patient population, approximately 90% had mild to moderate HTG with baseline TGs between 200 and 499 mg/dL. The remainder had severe HTG with baseline TGs between 500 and 877 mg/dL. Approximately 30% of patients were on lipid-lowering medications,
such as statins, and approximately 10% were diabetic.
Similar to our COLT study, the primary objective of the TRIFECTA
study was to evaluate the effect of CaPre on fasting plasma TGs in patients with TGs between
200-877
mg/dL and to assess the tolerability and safety of CaPre. The secondary objectives of the TRIFECTA study
were to evaluate:
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the effect of CaPre on fasting plasma TGs in patients with TGs between
200-499
mg/dL;
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the dose dependent effect on fasting plasma TGs in patients with TGs between
500-877
mg/dL; and
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the effect of CaPre in patients with mild to moderate HTG and severe HTG on fasting plasma levels of
LDL-C
(direct measurement), and on fasting plasma levels of
HDL-C,
non-HDL-C,
hs-CRP
and OM3 index.
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CaPre successfully met the TRIFECTAs
studys primary objective. The placebo-corrected percentage change in TGs were decreases of 9.1% (p=0.049) and 9.7% (p=0.044) for 1 gram and 2 grams of CaPre, respectively. Key secondary objectives were also met:
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there was a statistically significant decrease in
non-HDL-C
versus placebo (p=0.038), with the 2 gram group decreasing by 5.3% from baseline versus placebo over the
12-week
period;
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HDL-C
(good cholesterol) slightly increased at both the 1 gram and 2
gram levels; and
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LDL-C
(bad cholesterol) and slightly decreased at the 2 gram level.
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Finally, a statistically significant dose response increase in the OM3 index for patients on 1 gram and
2 grams versus placebo was noted. The OM3 index reflects the percentage of EPA and DHA in red blood cell fatty acids and the risk of cardiovascular disease is considered to be lower as the OM3 index increases.
CaPre was found to be safe and well tolerated at all doses tested, with no serious adverse events that were considered
treatment-related. Out of 387 randomized patients, a total of 7 (1.8%) were discontinued as a result of adverse events, three were on placebo, two were on 1 gram and two were on 2 grams. The predominant incidence was gastrointestinal-related, with
no difference between CaPre and placebo. The safety profiles of patients on CaPre and placebo were similar.
The COLT and
TRIFECTA clinical trials were conducted by JSS Medical Research, a CRO specializing in the pharmaceutical, biotechnology, nutraceutical and medical device industries, which is both owned and managed by Dr. John Sampalis, the brother of
Dr. Tina Sampalis, who previously was our President and Chief Global Strategy Officer. JSS was selected by us following a rigorous due diligence process. Our board of directors appointed an external independent auditor, SNC Lavalin Pharma, to
confirm and validate the clinical trials achievements, milestones and payments.
Government Regulation
United States Drug Development
Government authorities in the United States, at the federal, state and local level, and in other countries extensively
regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and
export and import of drug products such as CaPre. Generally, before a new drug can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific to each regulatory authority,
submitted for review and approved by the regulatory authority.
FDA Regulatory Process
In the United States, the FDA regulates drugs under the FDCA and its implementing regulations. Drugs are also subject to other
federal, state and local statutes and regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state and local statutes and regulations require the expenditure of substantial time and
financial resources.
In order to be marketed in the United States, CaPre must be approved by the FDA through the NDA
review process. The process required before a drug may be marketed in the United States generally involves the following:
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completion of extensive nonclinical (animal) and formulation studies in accordance with applicable regulations, including the FDAs Good Laboratory Practice, or GLP, regulations;
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submission of an investigational new drug, or IND, which must become effective before human clinical trials may begin in the United States;
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performance of adequate and well-controlled clinical trials in accordance with the applicable IND and other clinical study-related regulations, such as current Good Clinical Practices, to establish the safety and
efficacy of the proposed drug for its proposed indication;
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submission of an NDA for a new drug;
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45
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satisfactory completion of an FDA
pre-approval
inspection of the manufacturing facility or facilities where the drug is produced to assess compliance with cGMP to assure that the
facilities, methods and controls are adequate to preserve the drugs identity, strength, quality and purity;
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satisfactory completion of potential FDA audit of the nonclinical and/or clinical trial sites that generated the data in support of the NDA; and
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FDA review and approval of the NDA prior to any commercial marketing or sale of the drug in the United States.
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The data required to support an NDA is generated in two distinct development stages: nonclinical and clinical. The nonclinical
development stage generally involves synthesizing or otherwise producing the active component, developing the formulation and determining the manufacturing process, as well as carrying out
non-human
toxicology, pharmacology and drug metabolism studies in the laboratory, which support subsequent clinical testing. The sponsor must submit the results of the nonclinical tests, together with manufacturing information, analytical data, any available
clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND, which is a request for authorization from the FDA to administer an investigational drug product to humans. The IND automatically becomes effective
30 days after receipt by the FDA, unless the FDA raises concerns or questions regarding the proposed clinical trials. The FDA may also place the IND on clinical hold within that
30-day
time period. In
such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. A clinical hold may be imposed at any time before or during a clinical trial due to safety concerns or
non-compliance.
The clinical stage of development first involves the
administration of the investigational drug to healthy volunteers and then to patients with the disease being targeted with the drug, all done under the supervision of qualified investigators, generally physicians not employed by or under the trial
sponsors control, in accordance with cGCP. All research subjects must provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of
the clinical trial, dosing procedures, subject selection and exclusion criteria, data collection, and the parameters to be used to monitor subject safety and assess the investigational drugs efficacy. Each protocol, and any subsequent
amendments to the protocol or new investigators information, must be submitted to the FDA as part of the IND. Further, each clinical trial must be reviewed and approved by an independent institutional review board, or IRB, at or servicing each
institution at which the clinical trial will be conducted. An IRB is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical trials are minimized
and are reasonable in relation to anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject or its legal representative. There are also requirements governing the reporting of ongoing
clinical trials and completed clinical trial results to public registries, as well as reporting of safety information under the IND.
Clinical studies are generally conducted in three sequential phases that may overlap, known as Phase 1, Phase 2 and
Phase 3 clinical trials. Phase 1 generally involves a small number of healthy volunteers who are initially exposed to a single dose and then multiple doses of the investigational drug. The primary purpose of these studies is to assess the
metabolism, pharmacologic action, side effect tolerability and safety of the drug. Phase 2 trials typically involve studies in disease-affected patients to determine the dose required to produce the desired benefits. At the same time, safety
and further pharmacokinetic and pharmacodynamic information is collected, as well as identification of possible adverse effects and safety risks and preliminary evaluation of efficacy. Phase 3 clinical trials generally involve large numbers of
patients at multiple sites, often in multiple countries (from several hundred to several thousand subjects) and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use, and
to establish the overall benefit/risk relationship of the product and provide an adequate basis for product approval. Phase 3 clinical trials should, if possible, include comparisons with placebo and may include a comparison to approved
therapies. The duration of treatment is often extended to mimic the actual use of a product during marketing. Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA (Pivotal Studies).
Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA. In addition,
written IND safety reports must be submitted to the FDA and the investigators for serious and unexpected adverse events or any finding from tests in laboratory animals that suggests a significant risk for human subjects. The FDA, the IRB, or the
sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk.
46
Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board or committee. This
group provides oversight and will determine whether or not a trial may move forward at designated check points based on review of interim data from the study. A clinical trial may be terminated or suspended based on evolving business objectives
and/or competitive climate.
The manufacturing process must be capable of consistently producing quality batches of the
investigational drug and, among other things, must develop methods for testing the identity, strength, quality and purity of the final drug product. The sponsor must develop appropriate labeling that sets forth the conditions of intended use.
Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the drug candidate does not undergo unacceptable deterioration over its shelf life.
Post-approval studies, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing
approval. These studies are used to gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate the performance of Phase 4 studies as part of a post-approval
commitment, such as pediatric studies.
NDA and FDA Review Process
Nonclinical and clinical information is filed with the FDA in an NDA along with proposed labeling. The NDA is a request for
approval to market the drug and must contain proof of safety, purity, potency and efficacy, which is demonstrated by extensive nonclinical and clinical testing. Data may come from company-sponsored clinical trials intended to test the safety and
effectiveness of a use of a product, or from a number of alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and
effectiveness of the investigational drug product to the satisfaction of the FDA.
The submission of an NDA is subject to
the payment of substantial user fees; a waiver of such fees may be obtained under certain limited circumstances. FDA approval of an NDA must be obtained before marketing a drug in the United States. In addition, under the Pediatric Research Equity
Act, an NDA or supplement to an NDA must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation
for which the product is safe and effective. The FDA may grant deferrals for submission of data or full or partial waivers.
The FDA reviews all NDAs submitted before it accepts them for filing and may request additional information. The FDA must make
a decision on accepting an NDA for filing within 60 days of receipt. Once the submission is accepted for filing, the FDA begins an
in-depth
review of the NDA. Under the goals and policies agreed to by the
FDA under the Prescription Drug User Fee Act, or PDUFA, the FDA has ten months from the filing date in which to complete its initial review of a standard NDA and respond to the applicant. This review typically takes 12 months from the date the
NDA is submitted to the FDA including the screening which takes a period of 60 days. The FDA does not always meet its PDUFA goal dates for standard NDAs, and the review process is often significantly extended by FDA requests for additional
information or clarification.
After the NDA submission is accepted for filing, the FDA reviews the NDA to determine, among
other things, whether the proposed product is safe and effective for its intended use, and whether the product is being manufactured in accordance with cGMP to assure and preserve the products identity, strength, quality and purity. The FDA
will likely
re-analyze
the clinical trial data, which could result in extensive discussions with the FDA.
Before approving an NDA, the FDA will conduct a
pre-approval
inspection of the
manufacturing facilities for the new product to determine whether they comply with cGMP. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate
to assure consistent production of the product within required specifications. In addition, before approving an NDA, the FDA may also audit data from clinical trials to ensure compliance with cGCP requirements. After the FDA evaluates the
application, manufacturing process and manufacturing facilities, it will issue a Complete Response Letter, or CRL. A CRL indicates that the review cycle of the application is complete and whether the application is approved and, when applicable, the
CRL describes the specific deficiencies in the NDA and may require additional clinical data and/or an additional Phase 3 clinical trial(s), and/or other significant and time-consuming requirements related to clinical trials, nonclinical studies
or manufacturing. The applicant may either resubmit the NDA, addressing all of the deficiencies identified in the letter, or withdraw the application. Even if such data and information is submitted, the FDA may ultimately decide that the NDA does
not satisfy the criteria for approval.
47
If a product receives marketing approval, the approval may be significantly
limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications, warnings or precautions be included
in the product labeling, may condition the approval of the NDA on other changes to the proposed labeling, or may require a Risk Evaluation and Mitigation Strategy (REMS), which could limit the ability to market the drug once approved. The FDA may
also require the development of adequate controls and specifications, or a commitment to conduct post-market testing or clinical trials and surveillance to monitor the effects of approved products.
U.S. Post-Marketing Requirements
Following approval of a new product, a pharmaceutical company and the approved product are subject to continuing regulation by
the FDA, including, among other things, monitoring and recordkeeping activities, reporting to the applicable regulatory authorities of adverse experiences with the product, providing the regulatory authorities with updated safety and efficacy
information, product sampling and distribution requirements, and complying with promotion and advertising requirements, which include, among others, standards for
direct-to-consumer
advertising, restrictions on promoting drugs for uses or in patient populations that are not described in the drugs approved labeling, or
off-label
use, limitations on industry-sponsored scientific and educational activities, and requirements for promotional activities involving the internet. Although physicians may prescribe legally
available drugs for
off-label
uses, manufacturers and distributors may not market or promote such
off-label
uses. Modifications or enhancements to the product or its
labeling or changes of the site of manufacture are often subject to the approval of the FDA and other regulators, which may or may not be received or may result in a lengthy review process. In some cases, these changes will require the submission of
clinical data and the payment of a user fee.
U.S. Patent Term Restoration and Marketing Exclusivity
Depending upon the timing, duration and specifics of the FDA approval of our prescription drug candidates, some of our U.S.
patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of
up to five years as compensation for patent term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the products
approval date. The patent term restoration period is generally
one-half
the time between the effective date of an IND and the submission date of an NDA plus the time between the submission date of an NDA and
the approval of that application. Only one patent applicable to an approved drug is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. The USPTO in consultation with the FDA,
reviews and approves the application for any patent term extension or restoration. In the future, we intend to apply for restoration of patent term for one of our currently owned or licensed patents to add patent life beyond its current expiration
date, depending on the expected length of the clinical trials and other factors involved in the filing and review of the relevant NDA.
Non-U.S.
Drug Regulation
In Canada, biopharmaceutical product candidates are regulated by the Food and Drugs Act and the related rules and regulations,
which are enforced by the Therapeutic Products Directorate of Health Canada. In order to obtain approval for commercializing new drugs in Canada, the sponsor must satisfy many regulatory conditions. The sponsor must first complete preclinical
studies in order to file a clinical trial application, or CTA, in Canada. The sponsor will then receive different clearance authorizations to proceed with Phase I clinical trials, which can then lead to Phase 2 and Phase 3 clinical trials. Once all
three phases of trials are completed, the sponsor must file a registration file named a New Drug Submission, or NDS, in Canada. If the NDS demonstrates that the product was developed in accordance with the regulatory authorities rules,
regulations and guidelines and demonstrates favorable safety and efficacy and receives a favorable risk/benefit analysis, then the regulatory authorities issue a notice of compliance, which allows the sponsor to market the product.
In addition to regulations in the United States and Canada, we are subject to a variety of regulations governing clinical
studies and commercial sales and distribution of our products in other jurisdictions around the world. These laws and regulations typically require the licensing of manufacturing and contract research facilities, carefully controlled research and
testing of product candidates and governmental review and approval of results prior to marketing therapeutic product candidates. Additionally, they require adherence to good laboratory practices, good clinical practices and good manufacturing
practices during production. The process of new drug approvals by regulators in the United States, Canada and the European Union are generally considered to be among the most rigorous in the world.
48
Whether or not the FDA or Health Canada approval is obtained for a product, we
must obtain approval from the comparable regulatory authorities of other countries before we can commence clinical studies or marketing of the product in those countries. The approval process varies from country to country and the time may be longer
or shorter than that required for the FDA or Health Canada approval. The requirements governing the conduct of clinical studies, product licensing, pricing and reimbursement vary greatly from country to country. In some international markets,
additional clinical trials may be required prior to the filing or approval of marketing applications within the country.
Active
Pharmaceutical Ingredient Regulation
The FDA will regulate finished products containing APIs developed or under
development by us. Depending on its intended uses, a finished product containing the API may be regulated as a drug under the procedures described above. It may be possible to market a finished product containing an API developed or under
development by us as a dietary supplement. Dietary supplements do not require FDA premarket approval. However, it may be necessary to submit a notification to the FDA that a company intends to market a dietary supplement containing a
new dietary ingredient. In general, the regulatory requirements in other countries also depend on the nature of the finished product and do not focus on the API itself.
C.
|
Organizational Structure
|
We have no subsidiaries. As of June 26, 2017, Neptune owns 5,064,694 of our common shares, representing 34.4% of our
common shares issued and outstanding. Our common shares are voting, participating and have no par value. Neptune also owns a warrant entitling it to acquire 592,500 common shares.
D.
|
Property, Plants and Equipment
|
Our head office and operations are located at 545, Promenade Centropolis, suite 100, Laval, Québec, Canada, H7T 0A3. We
do not own our own manufacturing facility for the production of CaPre; however, we do own the proprietary equipment for producing the API and drug product. We currently do not have plans to develop our own manufacturing facility. However, this could
change in the foreseeable future, as we consider the most cost-effective approaches to producing CaPre while ensuring the highest level of quality. We currently depend on third party suppliers and manufacturers, such as Neptune, to produce our
required raw krill oil and drug substance and products. If CaPre is approved for distribution by the FDA, we initially expect to rely on cGMP-compliant third parties to manufacture NKPL66, which is API in CaPre, encapsulate, bottle and package
clinical supplies of CaPre.
We have entered into an agreement CordenPharma Chenôve, a third party CMO, for the
manufacturing of CaPre clinical material for the purposes of our planned Phase 3 program in accordance with cGMP regulations imposed by the FDA.
Item 4A.
|
Unresolved Staff Comments
|
Not applicable.
Item 5.
|
Operating and Financial Review and Prospects
|
This annual report contains forward-looking statements, principally in, but not limited to, Item 4 - Information on the
Company and Item 5 - Operating and Financial Review and Prospects. These statements may be identified by the use of words like plan, expect, aim, believe, project,
anticipate, intend, estimate, will, should, could and similar expressions in connection with any discussion, expectation, or projection of future operating or financial
performance, events or trends. In particular, these include statements about our strategy for growth, future performance or results of current sales and production, interest rates, foreign exchange rates, and the outcome of contingencies, such as
acquisitions and/or legal proceedings and intellectual property issues.
Forward-looking statements are based on certain
assumptions and expectations of future events that are subject to risks and uncertainties. Actual future results and trends may differ materially from historical results or those projected in any forward-looking statements depending on a variety of
factors, including, among other things, the factors discussed in this annual report under Item 3.D - Risk Factors and factors described in documents that
49
we may furnish from time to time to the SEC. Although the forward-looking information is based upon what we believe to be reasonable assumptions, no person should place undue reliance on
forward-looking information since actual results may vary materially from the forward-looking information. Except as required by law, we undertake no obligation to update publicly or revise any forward-looking statements because of new information.
Please refer to Special Note Regarding Forward-Looking Statements at the beginning of this annual report for additional details.
Managements Discussion and Analysis of Financial Situation and Operating Results
Fiscal Years Ended March 31, 2017, February 29, 2016 and February 28, 2015
Introduction
This
management discussion and analysis, or MD&A, is presented in order to provide the reader with an overview of our financial results and changes to our financial position as at March 31, 2017 and for the year then ended. This MD&A also
explains the material variations in our financial statements of operations, financial position and cash flows for our fiscal years ended March 31, 2017 February 29, 2016 and February 28, 2015.
This MD&A, should be read together with our audited financial statements for the fiscal years ended March 31, 2017,
February 29, 2016 and February 28, 2015 under Item 17. Financial Statements in this annual report. Our audited financial statements were prepared in accordance with IFRS, as issued by the IASB. Our financial results are
published in Canadian dollars. All amounts appearing in this MD&A are in thousands of Canadian dollars, except share and per share amounts or unless otherwise indicated.
Caution Regarding
Non-IFRS
Financial Measures
We use multiple financial measures for the review of our operating performance. These measures are generally IFRS financial
measures, but one adjusted financial measure,
Non-IFRS
operating loss (adding to net loss, finance expenses, depreciation and amortization and impairment loss, change in fair value of derivative warrant
liabilities, stock-based compensation and by subtracting finance income and deferred income tax recovery), is also used to assess our operating performance. This
non-IFRS
financial measure is derived from our
financial statements and is presented in a consistent manner. We use this measure, in addition to the IFRS financial measures, for the purposes of evaluating our historical and prospective financial performance, as well as our performance relative
to competitors. All of these measures also help us to plan and forecast future periods as well as to make operational and strategic decisions. We believe that providing this
Non-IFRS
information to investors,
in addition to IFRS measures, allows them to see our results through the eyes of our management, and to better understand our historical and future financial performance.
Securities regulations require that companies caution readers that earnings and other measures adjusted to a basis other than
IFRS do not have standardized meanings and are unlikely to be comparable to similar measures used by other companies. Accordingly, they should not be considered in isolation. We use
Non-IFRS
operating loss to
measure our performance from one period to the next without the variation caused by certain adjustments that could potentially distort the analysis of trends in our operating performance, and because we believe it provides meaningful information on
our financial condition and operating results. Our method for calculating
Non-IFRS
operating loss may differ from that used by other corporations.
We calculate our
Non-IFRS
operating loss measurement by adding to net loss, finance
expenses, depreciation and amortization and impairment loss, change in fair value of derivative warrant liabilities, stock-based compensation and by subtracting finance income and deferred tax recovery. Other items that do not impact our core
operating performance are excluded from the calculation as they may vary significantly from one period to another. Finance income/costs include foreign exchange gain (loss). We also exclude the effects of certain
non-monetary
transactions recorded, such as stock-based compensation, from our
Non-IFRS
operating loss calculation. We believes it is useful to exclude this item as it
is a
non-cash
expense. Excluding this item does not imply it is necessarily
non-recurring.
A reconciliation of net loss to
Non-IFRS
operating loss is presented further below.
Basis of Presentation of the Financial
Statements
Beginning in fiscal 2017, our fiscal year end is on March 31. Fiscal 2017 is a transition year, and
includes thirteen months of operations, beginning on March 1, 2016 and ending on March 31, 2017. As a result, the financial statements and corresponding notes to financial statements include two unaudited periods: the
one-month
period ended March 31, 2017 and the twelve-month period ended February 28, 2017.
50
Following the change of our year end to March 31, 2017 and the inclusion of
thirteen months of operations, this MD&A discusses and compares the thirteen-month period ended March 31, 2017, the twelve-month period ended February 29, 2016 and the twelve-month period ended February 28, 2015. In addition,
there is comparative discussion of our results of operations for the three-month periods ended February 28, 2017 and February 29, 2016 and a discussion on notable items related to the
one-month
result of operations ending March 31, 2017. The selected quarterly financial data includes the eight most recent fiscal quarters and are presented including the most recent quarter as the four-month quarter ended March 31, 2017.
We are subject to a number of risks associated with the conduct of our clinical program and their results, the establishment
of strategic alliances and the successful development of new products and their marketing. We have incurred significant operating losses and negative cash flows from operations since inception. To date, we have financed our operations through the
public offering and private placement of common shares and convertible debt, the proceeds from research grants and research tax credits, and the exercises of warrants, rights, and options. To achieve the objectives of our business plan, we plan to
raise the necessary funds through additional securities offerings and the establishment of strategic alliances as well as additional research grants and research tax credits. We anticipate that the products developed by us will require approval from
the FDA and equivalent regulatory organizations in other countries before their sale can be authorized. Our ability to ultimately achieve profitable operations is dependent on a number of factors outside of our control.
Our current assets of $10,187 as at March 31, 2017 include cash and cash equivalents totaling $9,772, mainly generated by
the net proceeds from our public offering and private placement completed on February 21, 2017 as well as the public offering completed on December 3, 2013 and private offering completed on February 7, 2014, which we refer to as the
previous offerings. Our liabilities total $3,753 at March 31, 2017 and are comprised primarily of $2,138 in amounts due to or accrued for creditors, $1,406 for unsecured convertible debentures and $209 for derivative warrant liabilities. Our
current assets as at this date are projected to be significantly less than needed to support our current liabilities as at that date when combined with the projected level of our expenses for the next twelve months, including not only the
preparation for, but the planned initiation of our Phase 3 program for our drug candidate, CaPre. Additional funds will also be needed for our expected expenses for the total CaPre Phase 3 research and development phase and other needed operations
beyond the next twelve months. In addition to having raised additional funds during the thirteen-month period ended March 31, 2017, we are working towards development of strategic partner relationships and plan to raise additional funds in
the future, but there can be no assurance as to when or whether we will complete any financing or strategic collaborations. In particular, raising financing is subject to market conditions and is not within our control. Additionally, although we
intend to continue to rely on the support of Neptune for a portion of our general and administrative needs, the continuance of this support is outside of our control. If we do not raise additional funds, find one or more strategic partners or do not
receive the continued support from Neptune, it may not be able to realize our assets and discharge our liabilities in the normal course of business. As a result, there exists a material uncertainty that casts substantial doubt about our ability to
continue as a going concern and, therefore, realize our assets and discharge our liabilities in the normal course of business. We currently have no other arranged sources of financing.
Our financial statements have been prepared on a going concern basis, which assumes we will continue our operations in the
foreseeable future and will be able to realize our assets and discharge our liabilities and commitments in the ordinary course of business. Our financial statements do not include any adjustments to the carrying values and classification of assets
and liabilities and reported expenses that may be necessary if the going concern basis was not appropriate for our financial statements. If we are unable to continue as a going concern, material write-downs to the carrying values of our assets,
including the intangible asset, could be required.
51
Selected Financial Information
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands of dollars, except per share data)
|
|
One-month
period ended
|
|
|
Three-month
period ended
|
|
|
Three-month
period ended
|
|
|
Thirteen-
month period
ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
March 31,
2017
|
|
|
February 28,
2017
|
|
|
February 29,
2016
|
|
|
March 31,
2017
|
|
|
February 29,
2016
|
|
|
February 28,
2015
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
Net loss
|
|
|
(769)
|
|
|
|
(2,598)
|
|
|
|
(1,919)
|
|
|
|
(11,247)
|
|
|
|
(6,317)
|
|
|
|
(1,655)
|
|
Basic and diluted loss per share
|
|
|
(0.05)
|
|
|
|
(0.23)
|
|
|
|
(0.18)
|
|
|
|
(1.01)
|
|
|
|
(0.59)
|
|
|
|
(0.16)
|
|
Non-IFRS
operating loss
(1)
|
|
|
(406)
|
|
|
|
(1,745)
|
|
|
|
(1,163)
|
|
|
|
(7,798)
|
|
|
|
(6,569)
|
|
|
|
(8,507)
|
|
Total assets
|
|
|
25,456
|
|
|
|
26,367
|
|
|
|
28,517
|
|
|
|
25,456
|
|
|
|
28,517
|
|
|
|
37,208
|
|
Working capital
(2)
|
|
|
8,049
|
|
|
|
8,510
|
|
|
|
12,185
|
|
|
|
8,049
|
|
|
|
10,184
|
|
|
|
18,020
|
|
Total
non-current
financial liabilities
|
|
|
1,615
|
|
|
|
1,576
|
|
|
|
156
|
|
|
|
1,615
|
|
|
|
156
|
|
|
|
2,357
|
|
Total equity
|
|
|
21,703
|
|
|
|
22,386
|
|
|
|
27,220
|
|
|
|
21,703
|
|
|
|
27,220
|
|
|
|
33,228
|
|
(1)
|
Non-IFRS operating loss (adding to net loss financial expenses (income), depreciation and amortization and
impairment of intangible asset, change in fair value of derivative warrant liabilities, stock-based compensation and by subtracting deferred income tax recovery) is not a standard measure endorsed by IFRS requirements. A reconciliation to our net
loss is presented further below.
|
(2)
|
Working capital is presented for information purposes only and represents a measurement of our short-term
financial health mostly used in financial circles. Working capital is calculated by subtracting current liabilities from current assets. Because there is no standard method endorsed by IFRS requirements, the results may not be comparable to similar
measurements presented by other public companies.
|
Reconciliation of Net Loss to
Non-IFRS
Operating Loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands of dollars, except per share data)
|
|
One-month
period ended
|
|
|
Three-month
period ended
|
|
|
Three-month
period ended
|
|
|
Thirteen-
month period
ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
March 31,
2017
|
|
|
February 28,
2017
|
|
|
February 29,
2016
|
|
|
March 31,
2017
|
|
|
February 29,
2016
|
|
|
February 28,
2015
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(769)
|
|
|
|
(2,598)
|
|
|
|
(1,919)
|
|
|
|
(11,247)
|
|
|
|
(6,317)
|
|
|
|
(1,655)
|
|
Add (deduct):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
86
|
|
|
|
158
|
|
|
|
108
|
|
|
|
674
|
|
|
|
309
|
|
|
|
1,553
|
|
Depreciation and amortization/
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Impairment of intangible assets
|
|
|
226
|
|
|
|
669
|
|
|
|
938
|
|
|
|
2,738
|
|
|
|
2,734
|
|
|
|
2,335
|
|
Financial expenses (income)
|
|
|
29
|
|
|
|
28
|
|
|
|
(176)
|
|
|
|
113
|
|
|
|
(1,094)
|
|
|
|
(1,916)
|
|
Change in fair value of derivative warrant liabilities
|
|
|
22
|
|
|
|
127
|
|
|
|
(114)
|
|
|
|
53
|
|
|
|
(2,201)
|
|
|
|
(8,824)
|
|
Deferred income tax recovery
|
|
|
|
|
|
|
(129)
|
|
|
|
|
|
|
|
(129)
|
|
|
|
|
|
|
|
|
|
Non-IFRS
operating loss
|
|
|
(406)
|
|
|
|
(1,745)
|
|
|
|
(1,163)
|
|
|
|
(7,798)
|
|
|
|
(6,569)
|
|
|
|
(8,507)
|
|
Stock-based compensation expense increased for the three-month period ended February 28,
2017 as 465,000 stock options were granted on February 24, 2017 compared to nil for the three-month period ended February 29, 2016. There are no notable matters in stock-based compensation expense and no grants for the
one-month
period ended March 31, 2017. The overall stock-based compensation expense increased for the thirteen-month period ending March 31, 2017 as a total of 1,300,400 stock options were granted compared
to 109,188 stock options being granted for the year ended February 29, 2016. The stock-based compensation expense decreased for the year ended February 29, 2016 compared to the same period in 2015 as the 2012 grants had fully vested.
Depreciation, amortization and impairment expense totaled $669 for the three-month period ended February 28, 2017 or $269
less than $938 for the three-month period ended February 29, 2016 based on $70 increased depreciation in the current period associated primarily with the new production equipment first used during this period offset by no current period
impairment charge compared to the $339 impairment charge recognized during the three-month period ended February 28, 2016. Depreciation, amortization and impairment expense totaled $2,738 for the thirteen-month period ended March 31,
2017 which approximated the same amount when compared to the year ended February 29, 2016. However, there was a change in the mix of this expense as the thirteen-month period ended March 31, 2017 included only depreciation and amortization
with the impact of one additional month of depreciation and amortization expense and the addition of new equipment generating incremental depreciation expense, but not the $339 impairment charge recognized during the year ended February 29,
2016. If the impairment charge is excluded from the expense for the year ended February 29, 2016, then the depreciation and amortization expense totaling $2,395 approximates the expense for the year ended February 28, 2015.
Financial expenses (income) totaled $28 for the three-month period ended February 28, 2017 or $204 less than ($176) for
the three-month period ended February 29, 2016 based primarily on a $134 foreign exchange gain in the prior period changing to a $22 foreign exchange loss in the current period combined with less interest income in
52
the current period without the prior year pledge impact supporting Neptune and interest expense associated with the convertible debt included in our recent private placement. The net financial
expenses (income) totaling $29 for the month ended March 31, 2017 also resulted primarily from the interest expense from our recent private placement. Net financial expenses (income) totaling $113 for the thirteen-month period ended
March 31, 2017 reflect a $1,207 decrease compared to ($1,094) for the year ended February 29, 2016 primarily resulting from the $1,023 foreign exchange gain recognized during the year ended February 29, 2016 changing to the $180
foreign exchange loss recognized during the thirteen-month period ended March 31, 2017. The foreign exchange changes resulted primarily from the utilization of US$-denominated cash and cash equivalents over the periods generating lower
US$-denominated cash and cash equivalents throughout the periods and at March 31, 2017 compared to February 29, 2016 and, the periods then ended combined with a decrease in the reporting US$ exchange rate. The US$-denominated cash, cash
equivalents and short-term investments totaled US$3,524 at March 31, 2017 and US$10,314 at February 29, 2016 and the exchange rate reporting of CA$ per US$ was $1.3299 at March 31, 2017 compared to $1.3531 at February 29, 2016.
Additionally, interest income for the thirteen-month period ended March 31, 2017 totaled $125 compared to $73 for the year ended February 29, 2016, and $39 in interest expense was incurred in the current period, including $31 in March, in
connection with the convertible debentures from the private placement. The net financial expenses (income) of ($1,094) for the year ended February 29, 2016 was $822 less than ($1,916) for the year ended February 28, 2015 based on the lower
foreign exchange gain that year.
The fair value of the derivative warrant liabilities totaled $209 at March 31, 2017,
or $53 more than the $156 fair value at February 29, 2016, $22 of which was recognized during the
one-month
ended March 31, 1017. The $156 fair value of the derivative warrant liabilities at
February 29, 2016 was $2,201 less than the $2,357 value at February 28, 2015 and the decline in value for the year-ended February 28, 2015 was $8,824. The fair value of the warrants is estimated at each reporting date using the
Black-Scholes option pricing model. The fair value of the warrants issued in connection with our previous offerings was determined to be $0.58 per warrant upon issuance, $0.09 per warrant at February 29, 2016 and $0.11 per warrant as of
March 31, 2017. In fiscal years 2016 and 2015, the decline in our stock price resulted in gains based on the change in fair value of the warrant liabilities reducing the corresponding liability in the statement of financial position.
We recorded a $129 deferred income tax recovery at February 28, 2017 to reduce to nil an income tax liability that was
attributable to the difference between the tax basis and the carrying amount of the unsecured convertible debentures.
The
non-IFRS
operating loss increased by $582 for the three-month period ended February 28, 2017 to $1,745 compared to $1,163 for the three-month period ended February 29, 2016, mainly due to an increase in
general and administrative (G&A) expenses and a smaller increase in research and development or (R&D) expenses, before consideration of stock-based compensation, amortization and depreciation. The
non-IFRS
operating loss increased by $1,229 for the thirteen-month period ended March 31, 2017 to $7,798 compared to $6,569 for the year-ended February 29, 2016. This increase was primarily due to
the incremental
one-month
period
non-IFRS
operating loss of $406 for March 2017 as well as increased G&A expenses compared to the prior period before consideration
of stock-based compensation and amortization and depreciation. There were no notable matters for the
one-month
period ended March 31, 2017. The
non-IFRS
operating
loss for the year ended February 29, 2015 totaled $8,507 or a $1,938 decrease compared to the year ended February 29, 2016.
Selected
Quarterly Financial Data
Fiscal Year ended March 31, 2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands of dollars, except per share data)
|
|
March 31,
|
|
|
November 30,
|
|
|
August 31,
|
|
|
May 31,
|
|
|
|
|
|
|
|
|
2017
(1)
|
|
|
2016
|
|
|
2016
|
|
|
2016
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(3,367)
|
|
|
|
(2,397)
|
|
|
|
(2,330)
|
|
|
|
(3,154)
|
|
Basic and diluted loss per share
|
|
|
(0.28)
|
|
|
|
(0.22)
|
|
|
|
(0.22)
|
|
|
|
(0.29)
|
|
Non-IFRS
operating loss
(2)
|
|
|
(2,151)
|
|
|
|
(1,737)
|
|
|
|
(1,625)
|
|
|
|
(2,286)
|
|
(1)
|
This fiscal quarter represents a period of four months ended March 31, 2017.
|
53
(2)
|
Non-IFRS
operating loss (adding to net loss financial expenses
(income), depreciation and amortization and impairment of intangible assets, change in fair value of derivative warrant liabilities, stock-based compensation and by subtracting deferred income tax recovery) is not a standard measure endorsed by IFRS
requirements. A reconciliation to our net loss is presented above.
|
Fiscal Year ended February 29, 2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands of dollars, except per share data)
|
|
February 29,
|
|
|
November 30,
|
|
|
August 31,
|
|
|
May 31,
|
|
|
|
|
|
|
|
|
2016
|
|
|
2015
|
|
|
2015
|
|
|
2015
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Net loss
|
|
|
(1,919)
|
|
|
|
(2,191)
|
|
|
|
(1,241)
|
|
|
|
(966)
|
|
Basic and diluted loss per share
|
|
|
(0.18)
|
|
|
|
(0.20)
|
|
|
|
(0.12)
|
|
|
|
(0.09)
|
|
Non-IFRS
operating loss
(1)
|
|
|
(1,163)
|
|
|
|
(1,988)
|
|
|
|
(1,485)
|
|
|
|
(1,933)
|
|
(1)
|
Non-IFRS
operating loss (adding to net loss financial expenses
(income), depreciation and amortization and impairment of intangible assets, change in fair value of derivative warrant liabilities, stock-based compensation and by subtracting deferred income tax recovery) is not a standard measure endorsed by IFRS
requirements. A reconciliation to our net loss is presented above.
|
The increase in net loss, net loss
per share and
non-IFRS
operating loss in the fourth quarter of 2017 can partially be explained by the inclusion of the additional month in comparison to the comparative three-month quarterly financial data.
The month of March 2017 explains an increase in the fourth quarter net loss of $769 or ($0.05) per share as well as an increase in
non-IFRS
operating loss of $406. The variances in net loss from quarter to
quarter are mainly due to the changes in fair value of the warrant liabilities, notably for the quarter ended May 31, 2015 with a gain of $1,708, as well as variations in foreign exchange gains or losses, particularly for the quarter ended
August 31, 2015 with a foreign exchange gain of $890. The quarterly
year-to-year
non-IFRS
operating loss variances are
mainly attributable to fluctuations in research and development expenses from
quarter-to-quarter
as well as an increase in general and administrative expenses over the
prior year in the last three quarters of fiscal 2017.
Results from Operations for the
One-Month
and Thirteen-Month Periods ended March 31, 2017 and the Three-Month Periods ended February 28, 2017 and February 29, 2016 and Years ended February 29, 2016 and February 28, 2015
The net loss totaling $2,598 or ($0.23) per share for the three-month period ended February 28, 2017 increased $679 or
($0.05) per share compared to a net loss totaling $1,919 or ($0.18) per share for the three-month period ended February 29, 2016. This resulted primarily from the $582 increased
non-IFRS
operating
loss explained below, $241 from the increased loss due to the change in value of the warrant derivative liability due to the reduction in our share price and a $204 financial expense increase led by a foreign exchange gain during the prior period
transitioning to a foreign exchange loss during the current period offset by no impairment charge in the current period compared to the $339 charge in the prior period combined with the $129 tax benefit recognized in the current period.
The net loss totaling $11,247 or ($1.01) per share for the thirteen-month period ended March 31, 2017 increased $4,930 or
($0.42) per share compared to the net loss totaling $6,317 or ($0.59) per share for the year ended February 29, 2016. This change resulted primarily based on the $1,229 increased
non-IFRS
operating loss
explained below, $2,254 from the increased loss due to the change in value of the warrant derivative liability due to the reduction in our share price, a $1,207 financial expense increase (led by a foreign exchange gain during the prior period
transitioning to a foreign exchange loss during the current period), and increased depreciation and stock compensation expense offset by no impairment charge in the current period compared to the $339 charge in the prior period combined with the
$129 tax benefit recognized in the current period.
The net loss totaling $6,317 or ($0.59) per share for the year ended
February 29, 2016 increased $4,662 or ($0.43) per share compared to the net loss totaling $1,655 or ($0.16) per share for the year ended February 28, 2015. This change resulted primarily based on the $7,445 decrease in net financial
income, including a $6,623 decrease in the fair value of the warrant liabilities and the $810 decrease in the foreign exchange gain offset by the $1,527 decrease in G&A expenses and $1,256 decrease in R&D expenses.
54
Breakdown of Major Components of Statement of Earnings and Comprehensive Loss for the
One-Month
and Thirteen-Month Periods ended March 31, 2017; Three-Month Periods ended February 28, 2017 and February 29, 2016; and Fiscal Years ended February 29, 2016 and February 28, 2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses
|
|
One-month
period ended
|
|
|
Three-month
period ended
|
|
|
Three-month
period ended
|
|
|
Thirteen-
month period
ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
March 31,
2017
|
|
|
February 28,
2017
|
|
|
February 29,
2016
|
|
|
March 31,
2017
|
|
|
February 29,
2016
|
|
|
February 28,
2015
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Salaries and benefits
|
|
|
104
|
|
|
|
376
|
|
|
|
332
|
|
|
|
1,294
|
|
|
|
989
|
|
|
|
465
|
|
Stock-based compensation
|
|
|
18
|
|
|
|
27
|
|
|
|
12
|
|
|
|
107
|
|
|
|
53
|
|
|
|
258
|
|
Research contracts
|
|
|
63
|
|
|
|
435
|
|
|
|
761
|
|
|
|
3,149
|
|
|
|
2,730
|
|
|
|
5,062
|
|
Professional fees
|
|
|
57
|
|
|
|
238
|
|
|
|
(118)
|
|
|
|
634
|
|
|
|
1,171
|
|
|
|
865
|
|
Depreciation and amortization
|
|
|
226
|
|
|
|
668
|
|
|
|
611
|
|
|
|
2,738
|
|
|
|
2,395
|
|
|
|
2,335
|
|
Impairment of intangible assets
|
|
|
|
|
|
|
|
|
|
|
339
|
|
|
|
|
|
|
|
339
|
|
|
|
|
|
Other
|
|
|
3
|
|
|
|
30
|
|
|
|
88
|
|
|
|
61
|
|
|
|
238
|
|
|
|
101
|
|
Government grants and tax credits
|
|
|
(45)
|
|
|
|
(215)
|
|
|
|
(291)
|
|
|
|
(330)
|
|
|
|
(349)
|
|
|
|
(264)
|
|
Total
|
|
|
426
|
|
|
|
1,559
|
|
|
|
1,734
|
|
|
|
7,653
|
|
|
|
7,566
|
|
|
|
8,822
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses
|
|
One-month
period ended
|
|
|
Three-month
period ended
|
|
|
Three-month
period ended
|
|
|
Thirteen-
month period
ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
March 31,
2017
|
|
|
February 28,
2017
|
|
|
February 29,
2016
|
|
|
March 31,
2017
|
|
|
February 29,
2016
|
|
|
February 28,
2015
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Salaries and benefits
|
|
|
110
|
|
|
|
493
|
|
|
|
64
|
|
|
|
1,198
|
|
|
|
409
|
|
|
|
617
|
|
Administrative fees
|
|
|
25
|
|
|
|
75
|
|
|
|
184
|
|
|
|
325
|
|
|
|
579
|
|
|
|
650
|
|
Stock-based compensation
|
|
|
68
|
|
|
|
132
|
|
|
|
95
|
|
|
|
567
|
|
|
|
256
|
|
|
|
1,296
|
|
Professional fees
|
|
|
52
|
|
|
|
231
|
|
|
|
137
|
|
|
|
1,053
|
|
|
|
616
|
|
|
|
593
|
|
Rent
|
|
|
10
|
|
|
|
30
|
|
|
|
(12)
|
|
|
|
121
|
|
|
|
67
|
|
|
|
99
|
|
Other
|
|
|
27
|
|
|
|
52
|
|
|
|
(37)
|
|
|
|
293
|
|
|
|
119
|
|
|
|
318
|
|
Total
|
|
|
292
|
|
|
|
1,013
|
|
|
|
431
|
|
|
|
3,557
|
|
|
|
2,046
|
|
|
|
3,573
|
|
Three-month period ended February 28, 2017 compared to three-month period ended February 29, 2016
During the three-month period ended February 28, 2017, we continued to move our R&D program forward as
planned on its previously announced timeline for the conduct of our clinical program and production
scale-up.
Though the $1,559 in total R&D expenses for the three-month period ended February 28, 2017
decreased $175 from $1,734 in total R&D expenses for the three-month period ended February 29, 2016, R&D expenses, before depreciation, amortization, intangible asset impairment, and stock-based compensation, increased by $92 for the
three-month period ended February 28, 2017 to $864 compared to $772 for the same period ended February 29, 2016. This increase was mainly attributable to the $356 increase in professional fees and a $76 reduction in government grants and
tax credits mitigated by a $326 decrease in research contracts. This expense mix changed with the transition of expenses from completed contracts under our successful Phase 2 bioavailability bridging clinical study to consultants to support
preparation for our clinical study program review with the FDA on the Phase 2 outcome combined with Phase 3 planning. This increase also resulted from $44 in incremental salaries and benefits primarily sourced from full-time compared to half-time
direct leadership and management of R&D when compared to the same period last year.
G&A expenses totaling $1,013
for the three-month period ended February 28, 2017 increased $582 from $431 for the three-month period ended February 29, 2016. This increase primarily resulted from the $545 increase in G&A expenses, before consideration of
stock-based compensation, to $881 for the three-month period ended February 28, 2017 compared to $336 for the same period ended February 29, 2016. This $545 increase was mainly
55
attributable to a $429 increase in salaries and benefits associated with the added full-time executive and managerial headcount to support our strategy and financing while becoming more
independent from Neptune, which was demonstrated with a $109 reduction in its related administrative fee. This increase also resulted from increased professional fees of $94 due primarily to expenses for maintaining the reactivated public and
investor relations programs, $42 in rent expense resulting primarily from a net credit recognized for the three-month period ended February 29, 2016 after a positive adjustment was negotiated with the lessor and other administration expense
increase of $89 after another cost management credit impact during the prior year period.
Thirteen-Month and
One-Month
Periods ended March 31, 2017 compared to the Fiscal Year-Ended February 29, 2016
R&D expenses totaled $7,653 for the thirteen-month period ended March 31, 2017, or an increase of $87 compared to
$7,566 in total R&D expenses for the year ended February 29, 2016. The R&D expense increase resulted primarily from $426 in total R&D expenses during March 2017, the thirteenth month of the period ended March 31, 2017, offset
by no intangible asset impairment charge in the thirteen-month period ended March 31, 2017 compared to the $339 charge last year. R&D expenses, before consideration of stock-based compensation, amortization and depreciation and impairments
of intangible assets, increased by $29 for the thirteen-month period ended March 31, 2017, including $182 during the month of March 2017, to $4,808 compared to $4,779 for the year ended February 29, 2016. The increase of $29 was mainly
attributable to the increase in research contracts of $419 and salaries and benefits of $305, principally offset by decreases in professional fees of $537, other expenses of $177 and government grants of $19. The increase of $419 in research
contracts during the thirteen-month period ended March 31, 2017 includes $63 relating to the additional
one-month
period ended March 31, 2017, but was primarily due to the cost of our Phase 2
bioavailability bridging clinical study initiated early in fiscal 2017 exceeding the cost of our other Phase 2 and
non-clinical
testing completed in fiscal 2016. The increased salaries and benefits represented
the cost of the expanded team headcount, led by full-time dedicated management (only part time in prior years), needed for us to continue our pharmaceutical process and analytical development and chemistry manufacturing control
scale-up,
as planned on our previously announced timeline. The decrease of $537 in professional fees is primarily due to a decrease in the development consulting fees incurred last year for our prior Phase 2
clinical study analytics and the planning for our Phase 2 bridging clinical study during the thirteen-month period ended March 31, 2017.
G&A expenses totaled $3,557 for the thirteen-month period ended March 31, 2017, or an increase of $1,511 compared to
total G&A expenses of $2,046 for the year ended February 29, 2016. This
period-to-period
increase includes $292 in total G&A expenses for the thirteenth
month of March 2017, $243 in increased stock-based compensation expense and a $976 increase in other G&A expenses, excluding the thirteenth month and stock-based compensation expenses. G&A expenses, excluding the stock-based compensation,
increased $1,200 to $2,990 for the thirteen-month period ended March 31, 2017, including $224 during the month of March 2017, compared to $1,790 for the year ended February 29, 2016. This increase was primarily attributable to a $789
increase in salaries and benefits offset by a $254 decrease in Neptune administrative fees, combined with increased professional fees of $437, rent of $54 and other expenses of $174. The increase in salaries and benefit expenses resulted from our
need for the added full-time executive and managerial headcount to lead our strategy, incremental financing and back office while supporting continued and expanded R&D with the need for full-time leadership from our management (which was only
part time in prior years). The increased professional fees were principally comprised of expenses associated with our investor and public relations program, the achievement of business development milestones, increased market research expenses, and
non-recurring
project legal and accounting fees associated with the
year-end
change and immigration-related fees for the U.S.-resident executives.
Fiscal Year ended February 29, 2016 compared to Fiscal Year ended February 28, 2015
R&D expenses totaled $7,566 for the year ended February 29, 2016, or $1,256 less than $8,822 in total R&D expenses
for the year ended February 28, 2015. This R&D expense decrease resulted primarily from R&D expenses, before consideration of stock-based compensation, amortization and depreciation and impairment of intangible assets, decreasing by
$1,450 to $4,779 from $6,229. This decrease is mainly attributable to a significant decrease in contract expenses related to our clinical studies of $2,332 and government grants increase of $85, partially offset by an increase in salaries and
benefits of $524, professional fees of $306 and other expenses of $137.
G&A expenses totaled $2,046 for the year ended
February 29, 2016, or $1,527 less than $3,573 for the year ended February 28, 2015. This G&A expense decrease resulted primarily from G&A expenses, before consideration of stock-based compensation, decreasing by $487 to $1,790 for
the year ended February 29, 2016 from $2,277 for
56
the year ended February 28, 2015. This decrease is mainly attributable to decreases in salaries of $208, administrative fees of $71, rent of $32 and other expenses of $199 partially offset
by an increase in professional fees of $23.
Liquidity and Capital Resources
Share Capital Structure
Our authorized share capital consists of an unlimited number of Class A (which we refer to in this annual report as our
common shares), Class B, Class C, Class D and Class E shares, without par value. Our issued and outstanding fully paid shares, stock options, restricted shares units and warrants, were as follows as at March 31, 2017,
February 28, 2017 and February 29, 2016:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2017
|
|
|
February 28, 2017
|
|
|
February 29, 2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class A shares, voting, participating and without par value
|
|
|
14,702,556
|
|
|
|
10,712,038
|
|
|
|
10,644,440
|
|
Stock options granted and outstanding
|
|
|
1,424,788
|
|
|
|
454,151
|
|
|
|
429,625
|
|
Restricted share units granted and outstanding
|
|
|
|
|
|
|
|
|
|
|
18,398
|
|
2017 Public offering warrants exercisable at $2.15,
until February 21,
2022
|
|
|
1,965,259
|
|
|
|
|
|
|
|
|
|
Series 2017 BW Broker warrants exercisable at $2.15, until
February 21,
2018
|
|
|
234,992
|
|
|
|
|
|
|
|
|
|
Series 2017 unsecured convertible debentures conversion option
contingent warrants
exercisable at $1.90, until February 21, 2020
(1)
|
|
|
1,052,630
|
|
|
|
|
|
|
|
|
|
Series 8 warrants exercisable at $1.50 USD, until December 3, 2018
(2)
|
|
|
1,840,000
|
|
|
|
1,840,000
|
|
|
|
1,840,000
|
|
Series 9 warrants exercisable at $13.30 until
December 3, 2018
|
|
|
161,654
|
|
|
|
161,654
|
|
|
|
161,654
|
|
Total fully-diluted shares
|
|
|
21,381,879
|
|
|
|
13,167,843
|
|
|
|
13,094,117
|
|
(1)
|
The debentures are convertible into common shares at a fixed price of $1.90 per common share, except if we pay before the maturity all or any portion of the convertible debentures. Should we pay all or any portion of
the convertible debenture before maturity, then warrants become exercisable at $1.90 per common share for the equivalent convertible debenture amount prepaid.
|
(2)
|
Total of 18,400,000 warrants, in order to obtain one common share, 10 warrants must be exercised for a total amount of $15.00 USD.
|
Cash Flows and Financial Condition between the
One-Month
Period ended March 31, 2017;
Three-Month Periods ended February 28, 2017 and February 29, 2016; Thirteen-Month Period ended March 31, 2017; and Fiscal Years ended February 29, 2016 and February 28, 2015
Operating Activities
During the
one-month
period ended March 31, 2017, our operating activities used
cash of $746, as primarily explained in the
non-IFRS
operating loss section above. The use of cash flow in operating activities for the
one-month
period ended
March 31, 2017 is mainly attributable to net loss, as explained in the Reconciliation of Net Loss to
Non-IFRS
Operating Loss section above, further modified by changes in working capital, excluding cash.
During the three-month periods ended February 28, 2017 and February 29, 2016, our operating activities used cash
of $1,425 and $1,691, respectively, as primarily explained in the
non-IFRS
operating loss section above. The use of cash flows in operating activities for the three-month periods ended February 28, 2017
and February 29, 2016 when compared to the net losses for each period are mainly attributable to the change in
non-cash
operating items, as explained in the Reconciliation of Net Loss to
Non-IFRS
Operating Loss section above, further modified by changes in working capital, excluding cash.
During the thirteen-month period ended March 31, 2017 and the years ended February 29, 2016 and February 28,
2015, our operating activities used cash of $6,958, $6,574 and 7,198, respectively, as primarily explained in the Reconciliation of Net Loss to
Non-IFRS
Operating Loss section above. The use of cash flows in
operating activities for the thirteen-month period ended March 31, 2017 and the years ended February 29, 2016 and February 28, 2015 when compared to the net losses for each period are mainly attributable to the change in
non-cash
operating items, as explained in the Reconciliation of Net Loss to
Non-IFRS
Operation Loss section above, offset by reductions in working capital, excluding cash.
57
Investing Activities
During the three-month period ended February 28, 2017, our investing activities generated cash of $3,327, compared to
using cash of $11 for the three-month period ended February 29, 2016. The cash generated by investing activities during the three-month period ended February 28, 2017 was mainly due to the maturity of short-term investments of $4,031,
offset by the acquisition of equipment totaling $733.
During the thirteen-month period ended March 31, 2017 and the
years ended February 29, 2016 and February 28, 2015, our investing activities generated cash of $6,888, $8,229 and $7,627, respectively. The cash generated by investing activities during the thirteen-month period ended March 31, 2017
was mainly due to the maturity of short-term investments of $22,030, offset by reinvestment in short-term investments totaling $12,765 and the acquisition of equipment totaling $2,527. The cash generated by investing activities during the year-ended
February 29, 2016 was mainly due to the maturity of short-term investments of $20,437, offset by the reinvestment in short-term investments totaling $11,954 and acquisition of equipment of $276. The cash generated by investing activities during
the year-ended February 28, 2015 was mainly due to the maturity of short-term investments of $22,150, offset by the reinvestment in short-term investments totaling $14,478.
Financing Activities
During the three-month period ended February 28, 2017, our financing activities generated cash of $6,924 The cash
generated by financing activities during the three-month period ended February 28, 2017 was mainly due to the net proceeds from our public offering of $5,044 and net proceeds from our private placement of $1,882.
During the thirteen-month period ended March 31, 2017, our financing activities generated cash of $6,864 and decreased
from the three-month period ending February 28, 2017, as certain transaction costs associated with the financing activities were paid. The cash generated by financing activities during the thirteen-month period ended March 31, 2017 was
mainly due to the net proceeds from our public offering of $5,010 and net proceeds from our private placement of $1,872.
Overall, our cash increased by $6,745, $1,716 and by $635, for the thirteen-month period ended March 31, 2017 and the
years ended February 29, 2016 and February 28, 2015, respectively. Cash and cash equivalents as at March 31, 2017 totaled $9,772.
We are subject to a number of risks associated with the conduct of our clinical program and their results, the establishment of
strategic alliances and the successful development of new products and their marketing. We have incurred significant operating losses and negative cash flows from operations since inception. To date, we have financed our operations through the
public offering and private placement of common shares and convertible debt, the proceeds from research grants and research tax credits, and the exercises of warrants, rights, and options. To achieve the objectives of our business plan, we plan to
raise the necessary funds through additional securities offerings and the establishment of strategic alliances as well as additional research grants and research tax credits. We anticipate that the products developed by us will require approval from
the FDA and equivalent regulatory organizations in other countries before their sale can be authorized. Our ability to ultimately achieve profitable operations is dependent on a number of factors outside of our control.
Our current assets of $10,187 as at March 31, 2017 include cash and cash equivalents totaling $9,772, mainly generated by
the net proceeds from our public offering and private placement completed on February 21, 2017 as well as the public offering completed on December 3, 2013 and private offering completed on February 7, 2014, which we refer to as the
previous offerings. Our liabilities total $3,753 at March 31, 2017 and are comprised primarily of $2,138 in amounts due to or accrued for creditors, $1,406 for unsecured convertible debentures and $209 for derivative warrant liabilities. Our
current assets as at this date are projected to be significantly less than needed to support our current liabilities as at that date when combined with the projected level of our expenses for the next twelve months, including not only the
preparation for, but the planned initiation of our Phase 3 program for our drug candidate, CaPre. Additional funds will also be needed for our expected expenses for the total CaPre Phase 3 research and development phase beyond the next twelve
months. In addition to having raised additional funds during the thirteen-month period ended March 31, 2017, we are working towards development of strategic partner relationships and plan to raise additional funds in the future, but there
can be no assurance as to when or whether we will complete any financing or strategic collaborations. In particular, raising financing is subject to market conditions and is not within our control. Additionally, although we intend to continue to
rely on the support of Neptune for a portion of our general and administrative needs, the continuance of this support is outside of our control. If we do not raise additional funds, find one or more strategic partners or do not receive the continued
58
support from Neptune, it may not be able to realize our assets and discharge our liabilities in the normal course of business. As a result, there exists a material uncertainty that casts
substantial doubt about our ability to continue as a going concern and, therefore, realize our assets and discharge our liabilities in the normal course of business. We currently have no other arranged sources of financing.
2017 Public Offering
On February 21, 2017, we closed a public offering issuing 3,930,518 units at a price of $1.45 per unit for gross proceeds
of $5,699. Each unit consists of one common share and one half of one common share purchase warrant. Each whole warrant entitles the holder to purchase one common share at an exercise price of $2.15 per common share, at any time until
February 21, 2022. The units issued as part of the public offering are considered equity instruments. The transaction costs associated with the public offering amounted to $1,190. The proceeds and transaction costs were allocated to share
capital.
As part of the transaction, we also issued broker warrants to purchase up to 234,992 common shares. Each broker
warrant entitles the holder to acquire one common share at an exercise price of $2.15 per common share, at any time until February 21, 2018. The total costs associated with the broker warrants are accounted for at fair value using the
Black-Scholes pricing model; they amounted to $144 and were recorded to contributed surplus with the offsetting entry as a reduction of share capital.
The warrants issued as part of the units of the public offering and the broker warrants, include an acceleration
right, related to our right to accelerate the expiry date of the warrants. The acceleration right clause means our right to accelerate the expiry date to a date that is not less than 30 days following delivery of the acceleration notice if, at
any time at least four months after the effective date, the volume weighted average trading price of our common shares equals or exceeds $2.65 for a period of 20 consecutive trading days on the TSXV.
Additionally, as part of the public offering and convertible debt transactions, a total of 60,000 common shares were issued by
us as equity settled share-based payments for services received from an employee of Neptune at a price of $1.57 per share for a total cost of $94. The equity settled share-based payment costs have been allocated between the share capital for a cost
that amounted to $85 and debt for a cost that amounted to $9 based on relative value.
Unsecured Convertible Debentures and
Contingent Warrants
Concurrent with our public offering, on February 21, 2017, we issued $2,000 aggregate
principal amount of unsecured convertible debentures maturing on February 21, 2020 and contingent warrants to acquire up to 1,052,630 common shares in a private placement transaction. The principal may be prepaid, in whole or in part, at any
time and from time to time, in cash, at our sole discretion
.
The debentures are convertible into common shares at any time by the holder at a fixed price of $1.90 per common share, except if we pay before the maturity all or any portion of
the convertible debentures. Should we pay all or any portion of the convertible debentures before maturity, then warrants become exercisable at $1.90 per common share for the equivalent convertible debenture amount prepaid. The contingent warrants
will be exercisable for the remaining term of the convertible debentures for the same price as the conversion options. The unsecured convertible debentures were issued at a discount of 3.5% to the principal amount, for aggregate gross proceeds of
$1,930.
The convertible debentures provide us with an
accelerated conversion right whereby we may, at any time at
least four months after the date of issuance of the convertible debentures, accelerate the conversion of the debentures to common shares in the event that the volume weighted average price of our common shares on the TSXV is equal to or exceeds
$2.65, subject to customary adjustment provisions, during 20 consecutive trading days.
The interest to be paid on the
convertible debentures is 8% per annum, payable on a quarterly basis in cash or common shares or a combination thereof, commencing on March 31, 2017. The decision to pay the interest due in cash or shares is at our discretion and the number of
common shares to be issued will be calculated at the current market price as at the close of business on the day before the interest payment is to be made. Payment in shares will be at a floor price of $0.10 per share, with the difference between
the amount payable and the amount computed at floor price payable in cash.
The proceeds of the private placement were
split between the liability and the equity at the time of issuance. Both the conversion option and contingent warrants are considered the equity component of the private placement. The fair value of the liability component was determined through a
discounted cash flow analysis using a
59
discount rate of 20% that was set based on a similar debt and maturity considering our credit risk excluding the conversion option and contingent warrants. The amount allocated to the equity
component is the residual amount after deducting the fair value of the financial liability component from the fair value of the entire compound instrument. Subsequent to initial recognition, the liability is measured at amortized cost calculated
using the effective interest rate method and will accrete up to the principal balance at maturity. The interest accretion is presented as a financial expense. The equity component is not
re-measured.
Transaction costs were allocated to the components in proportion to their initial carrying amounts. The portion allocated to the liability was recognized as a reduction of the debt whereas the portion allocated to other equity was recognized as a
reduction to other equity.
The fair value of the liability portion at the time of issuance was determined to be $1,519 and
the transaction costs and debt discount amounted to $134, of which $30 is still unpaid as at March 31, 2017. The residual of the proceeds allocated to the equity component amounted to $481 and the transactions costs amounted to $43, of which
$10 is unpaid at March 31, 2017.
Use of Funds
We have used and intend to continue to use the net proceeds from the public offering, the private placement and our previous
offerings to fund the completion of our manufacturing
scale-up
and the clinical and regulatory planning and preparations necessary to be ready to enroll the first patient in our planned Phase 3 program for
CaPre, intellectual property expansion, business development activities, general and administrative expenses, and working capital. We currently project, however, after our end of Phase 2 meeting with the FDA, which took place after the closing
of our public offering and private placement financing, that most of the more than $1 million net proceeds that we raised over our originally anticipated offering amount will be used for the clinical program preparation based now on the plan
being better defined after the FDA meeting, including our plan to conduct two smaller studies instead of one larger study.
Financial Position
The following table details the significant changes to our statements of financial position as at March 31, 2017 compared
to February 29, 2016:
(In thousands of dollars)
|
|
|
|
|
|
|
Accounts
|
|
|
Increase
(Decrease)
|
|
|
Comments
|
Cash and cash equivalents
|
|
|
6,745
|
|
|
See cash flow statement
|
Short-term investments, including restricted investments
|
|
|
(9,443)
|
|
|
Maturity of short-term investments, decrease in investments
|
Receivable
|
|
|
(193)
|
|
|
Payments received
|
Prepaid expenses
|
|
|
(247)
|
|
|
Completion of research contracts
|
Equipment
|
|
|
2,594
|
|
|
Acquisition of laboratory and production equipment
|
Intangible asset
|
|
|
(2,517)
|
|
|
Amortization
|
Trade and other payables
|
|
|
1,000
|
|
|
Increase in expenses and research contracts
|
Payable to parent corporation
|
|
|
(3)
|
|
|
Payment made to parent company
|
Derivative warrant liabilities
|
|
|
53
|
|
|
Change in fair value
|
Unsecured convertible debentures
|
|
|
1,406
|
|
|
Debt issued in Private Placement transaction
|
See the statement of changes in equity in our financial statements in Item 17. Financial Statements
for details of changes to the equity accounts from February 29, 2016.
Derivative Warrant Liabilities
As of March 31, 2017, the amount of $209 included in liabilities represents the fair value of the warrants issued as
part of our previous offerings. The warrants forming part of the units issued in connection with our previous offerings are derivative liabilities for accounting purposes due to the currency of the exercise price (US$) being different from our
functional currency (CA$). The warrant liabilities will be settled in common shares. The fair value of the warrants issued in connection with our previous offerings was determined to be $0.58 per warrant upon issuance and $0.11 per warrant as of
March 31, 2017. The fair value of the warrants is revalued at each reporting date.
60
Contractual Obligations,
Off-Balance-Sheet
Arrangements and
Commitments
We have no
off-balance
sheet arrangements, except for the
following commitments. As at March 31, 2017, our liabilities are $3,753, of which $2,138 is due within twelve months, $209 relates to a derivative warrant liability that will be settled in common shares and $1,406 relates to unsecured
convertible debentures, described in note 11 of our financial statements, which includes $21 in interest accretion and will be settled either in cash or common shares. The principal amount of unsecured convertible debentures may be prepaid, in whole
or in part, at any time and from time to time, in cash, at our sole discretion
.
The debentures are convertible into common shares at a fixed price of $1.90 per common share, except if we pay before the maturity all or any portion of the
convertible debentures.
A summary of our contractual obligations at March 31, 2017, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands of dollars)
|
|
Total
|
|
|
1 year or less
|
|
|
1 to 3 years
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
Trade and other payables
|
|
|
2,138
|
|
|
|
2,138
|
|
|
|
|
|
Research and development contracts
|
|
|
917
|
|
|
|
917
|
|
|
|
|
|
Purchase obligation of equipment
|
|
|
21
|
|
|
|
21
|
|
|
|
|
|
Unsecured convertible debentures
|
|
|
2,463
|
|
|
|
160
|
|
|
|
2,303
|
|
Total
|
|
|
5,539
|
|
|
|
3,236
|
|
|
|
2,303
|
|
Significant
commitments as of March 31, 2017 include:
Research and Development Agreements
In the normal course of business, we have signed agreements with various partners and suppliers for them to execute R&D
projects and to produce certain tools and equipment. We have reserved certain rights relating to these projects. We initiated R&D projects that are planned to be conducted over the next
12-month
period for
a total cost of $2,169, of which an amount of $785 has been paid to date. As at March 31, 2017, an amount of $467 is included in Trade and other payables in relation to these projects. We have also entered into a contract to
purchase production equipment for a total cost of $1,162 to be used in the manufacturing of the clinical and future commercial supply of CaPre, of which an amount of $853 has been paid to date. As at March 31, 2017, an amount of $288 is
included in Trade and other payables related to this equipment.
Related Party Transactions
During the periods specified below, we were charged by Neptune for the purchase of research supplies and for certain costs
incurred by Neptune for our benefit, as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands of dollars)
|
|
One-month
period ended
|
|
|
Three-month
period ended
|
|
|
Three-month
period ended
|
|
|
Thirteen-
month
period
ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
|
March 31,
2017
|
|
|
|
February 28,
2017
|
|
|
|
February 29,
2016
|
|
|
|
March 31,
2017
|
|
|
|
February 29,
2016
|
|
|
|
February 28,
2015
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
Research and development expenses
|
|
|
1
|
|
|
|
6
|
|
|
|
24
|
|
|
|
60
|
|
|
|
371
|
|
|
|
344
|
|
General and administrative expenses
|
|
|
41
|
|
|
|
241
|
|
|
|
215
|
|
|
|
618
|
|
|
|
790
|
|
|
|
876
|
|
Total
|
|
|
42
|
|
|
|
247
|
|
|
|
239
|
|
|
|
678
|
|
|
|
1,161
|
|
|
|
1,220
|
|
We
purchased from Neptune research and development supplies totaling $113, of which $73 as at March 31, 2017 is recorded in prepaid expenses and will be expensed as used.
Where Neptune incurs specific incremental costs for our benefit, it charges those amounts directly. Costs that benefit more than one entity of
the Neptune group are charged by allocating a fraction of costs incurred by Neptune that is commensurate to the estimated fraction of services or benefits received by each entity for those items. These charges do not represent all charges incurred
by Neptune that may have benefited us. Also, these charges do not necessarily represent the cost that we would otherwise need to incur, should we not receive these services or benefits through the shared resources of Neptune.
61
On January 7, 2016, Neptune announced the acquisition of Biodroga
Nutraceuticals Inc. As part of this transaction, we pledged an amount of $2 million, or the committed funds, to partly guarantee the financing for the transaction under a pledge agreement. Neptune had agreed to pay us an annual fee on the
committed funds outstanding at an annual rate of 9% during the first six months and 11% for the remaining term of the pledge agreement. On September 20, 2016, Neptune fully released the pledged amount. We recognized interest revenue in the
amount of $89 during the thirteen-month period ended March 31, 2017 and nil for the month ended March 31, 2017.
The payable to Neptune primarily for general and administrative shared services has no specified maturity date for payment or
reimbursement and does not bear interest.
Use of Estimates and Measurement of Uncertainty
The preparation of the financial statements in conformity with IFRS requires our management to make judgments, estimates and
assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. Estimates are based on managements best knowledge of current
events and actions that we may undertake in the future. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future
periods affected. Critical judgments in applying accounting policies that have the most significant effect on the amounts recognized in the financial statements include identification of triggering events indicating that the intangible assets might
be impaired and the use of the going concern basis of preparation of the financial statements. At the end of each reporting period, management assesses the basis of preparation of the financial statements. The financial statements have been prepared
on a going concern basis in accordance with IFRS. The going concern basis of presentation assumes that we will continue our operations for the foreseeable future and can realize our assets and discharge our liabilities and commitments in the normal
course of business. Assumptions and estimation uncertainties that have a significant risk of resulting in a material adjustment within the next financial year include determination of the recoverable amount of our cash generating unit, or CGU, and
measurement of derivative warrant liabilities and stock-based compensation. Also, management uses judgment to determine which research and development, or R&D, expenses qualify for R&D tax credits and in what amounts. We recognize the tax
credits once we have reasonable assurance that they will be realized. Recorded tax credits are subject to review and approval by tax authorities and therefore, could be different from the amounts recorded.
Critical Accounting Policies
Impairment of
Non-Financial
Assets
The carrying value of our license asset is reviewed at each reporting date to determine whether there is any indication of
impairment. If any such indication exists, then the CGUs recoverable amount is estimated. The identification of impairment indicators and the estimation of recoverable amounts require the use of judgment.
Derivative Warrant Liabilities
The warrants forming part of the units issued in our public offering are derivative liabilities for accounting purposes due to
the currency of the exercise price being different from our functional currency. The derivative warrant liabilities are required to be measured at fair value at each reporting date with changes in fair value recognized in earnings. We use
Black-Scholes pricing model to determine the fair value. The model requires the assumption of future stock price volatility, which is estimated based on weighted average historic volatility. Changes to the expected volatility could cause significant
variations in the estimated fair value of the derivative warrant liabilities.
Stock-based Compensation
We have a stock-based compensation plan, which is described in note 15 of our financial statements in Item 17. Financial
Statements. We account for stock options granted to employees based on the fair value method, with fair value determined using the Black-Scholes model. The Black Scholes model requires certain assumptions such as future stock price volatility
and expected life of the instrument. Expected volatility is estimated based on weighted average historic volatility. The expected life of the instrument is estimated based on historical experience and general holder behavior. Under the fair value
method, compensation cost is measured at fair value at date of
62
grant and is expensed over the awards vesting period with a corresponding increase in contributed surplus. For stock options granted to
non-employees,
we measure based on the fair value of services received, unless those are not reliably estimable, in which case we measure the fair value of the equity instruments granted. Compensation cost is
measured when we obtain the goods or the counterparty renders the service.
Tax Credits
Refundable tax credits related to eligible expenses are accounted for as a reduction of related costs in the year during which
the expenses are incurred as long as there is reasonable assurance of their realization.
Future Accounting Changes
A number of new standards, interpretations and amendments to existing standards were issued by the IASB, or the IFRS
Interpretations Committee, or IFRIC, that are mandatory but not yet effective for the thirteen-month and
one-month
periods March 31, 2017 and have not been applied in preparing our financial statements.
The following standards have been issued by the IASB with effective dates in the future that have been determined by management to impact the financial statements:
Financial Instruments
On July 24, 2014, the IASB issued the final version of IFRS 9,
Financial Instruments,
which addresses the
classification and measurement of financial assets and liabilities, impairment and hedge accounting, replacing IAS 39,
Financial Instruments: Recognition and Measurement
. IFRS 9 is effective for annual periods beginning on or after
January 1, 2018, with earlier adoption permitted. We intend to adopt IFRS 9 in our financial statements for the annual period beginning on April 1, 2018. We have not yet assessed the impact of adoption of IFRS 9, and do not intend to
early-adopt IFRS 9 in our financial statements.
Amendments to IFRS 2 Classification and Measurement of Share-Based Payment Transactions
On June 20, 2016, the IASB issued amendments to IFRS 2,
Share-Based Payment
, clarifying how to account
for certain types of share-based payment transactions. The amendments apply for annual periods beginning on or after January 1, 2018. Earlier application is permitted. As a practical simplification, the amendments can be applied prospectively.
Retrospective, or early application is permitted if information is available without the use of hindsight. The amendments provide requirements on the accounting for the effects of vesting and
non-vesting
conditions on the measurement of cash-settled share-based payments; share-based payment transactions with a net settlement feature for withholding tax obligations; and a modification to the terms and conditions of a share-based payment that changes
the classification of the transaction from cash-settled to equity-settled. We intend to adopt the amendments to IFRS 2 in our financial statements for the annual period beginning on April 1, 2018. We have not yet assessed the impact of adoption
of the amendments of IFRS 2, and do not intend to early-adopt these amendments in our financial statements.
Credit Risk
Credit risk is the risk of a loss if a customer or counterparty to a financial asset fails to meet its contractual obligations.
We have credit risk relating to cash, cash equivalents and short-term investments, which we manage by dealing only with highly-rated Canadian financial institutions. The carrying amount of financial assets, as disclosed in the statements of
financial position, represents our credit exposure at the reporting date.
Currency Risk
We are exposed to the financial risk related to the fluctuation of foreign exchange rates and the degrees of volatility of
those rates. Foreign currency risk is limited to the portion of our business transactions denominated in currencies other than the Canadian dollar. Fluctuations related to foreign exchange rates could cause unforeseen fluctuations in our operating
results. A portion of our expenses, mainly related to research contracts and purchase of production equipment, is incurred in US dollars and in Euros, for which no financial hedging is required. There is a financial risk related to the fluctuation
in the value of the US dollar and the Euro in relation to the Canadian dollar. In order to minimize the financial risk related to the fluctuation in the value of the US dollar in relation to the Canadian dollar, funds continue to be invested as
short-term investments in the US dollar. A significant portion of our cash and cash equivalents are denominated in US dollars, further exposing us to fluctuations in the value of the US dollar in relation to the Canadian dollar. See Note 19 of our
financial statements in Item 17. Financial Statements.
63
Interest Rate Risk
Interest rate risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of
changes in market rates. As at March 31, 2017, February 28, 2017 and February 29, 2016, our cash and cash equivalents and our short term investments were subject to fluctuations in short-term fixed interest rates.
Our capacity to reinvest the short-term amounts with equivalent return will be impacted by variations in short-term fixed
interest rates available on the market. Management believes the risk we will realize a loss as a result of the decline in the fair value of its short-term investments is limited because these investments have short-term maturities and are generally
held to maturity. Our capacity to reinvest the short-term amounts with equivalent return will be impacted by variations in short-term fixed interest rates available on the market. Management believes the risk we will realize a loss as a result of
the decline in the fair value of our short-term investments is limited because these investments have short-term maturities and are generally held to maturity.
Liquidity Risk
Liquidity
risk is the risk that we will not be able to meet our financial obligations as they fall due. We manage liquidity risk through the management of its capital structure and financial leverage, as outlined in Note 22 to our financial statements in
Item 17. Financial Statements. We also manage liquidity risk by continuously monitoring actual and projected cash flows. Our board of directors reviews and approves our operating budgets, and reviews material transactions outside the
normal course of business. Our contractual obligations related to financial instruments and other obligations and liquidity resources are presented in Liquidity and Capital Resources.
Item 6.
|
Directors, Senior Management and Employees
|
A.
|
Directors and Senior Management
|
The following table sets out the
name and the province or state and country of residence of each of our directors and all offices with us held by them, their principal occupation, the year in which they became a director, and the number of common shares they have declared to
beneficially own, directly or indirectly, or over which control or direction is exercised by them.
|
|
|
|
|
|
|
Name, Province or State, as the case may be,
and
Country of Residence of each Director
|
|
Principal Occupation
|
|
First Year
as Director
|
|
Number of Common Shares
Beneficially Owned or
Controlled
or Directed by Each Director
|
Roderick N. Carter
California, United States
Chairman of the Board
|
|
Principal, Aquila Life Sciences LLC
|
|
2015
|
|
-
|
Jean-Marie (John) Canan
Florida, United States
|
|
Corporate Director
|
|
2016
|
|
57,500
|
Janelle DAlvise
California, United States
|
|
President and CEO of Acasti
|
|
2016
|
|
52,500
|
James S. Hamilton
Québec, Canada
|
|
President and CEO of Neptune Technologies & Bioressources Inc.
|
|
2015
|
|
-
|
Leendert H. Staal
Maryland, United States
|
|
Independent consultant and owner of Staal Consulting LLC
|
|
2016
|
|
-
|
The following is a brief biography of our directors and senior management:
Dr. Roderick N. Carter
Dr. Carter has a strong history of contributions to healthcare through clinical, research, business and people leadership.
He has significant experience developing and commercializing nutraceutical and pharmaceutical products and has successfully led clinical research and business development strategies for cardiovascular and inflammation related diseases.
Dr. Carter is currently Principal at Aquila Life Sciences LLC, a consulting firm he
64
founded in April 2008 focusing on pharmaceutical development and commercialization. Prior to this, he was Vice President of Clinical Development at Reliant Pharmaceuticals, which developed the
OM3 cardiovascular drug LOVAZA, and today is a wholly-owned subsidiary of GlaxoSmithKline. He also served as Executive Director at Merck and Co., USA, President and Chief Executive Officer of WellGen and Senior Medical Director at Pfizer Inc.,
USA. Dr. Carter received his Medical Degree from the University of Witwatersrand, Johannesburg, along with a Master of Science degree in Sports Medicine from Trinity College, Dublin.
Janelle DAlvise (also our CEO)
Ms. DAlvise has extensive experience in diagnostics, medical devices, pharmaceuticals and drug discovery research
tools. Until recently, Ms. DAlvise was the President and Chairman of Pediatric Bioscience. Before that, she was the CEO of Gish Biomedical, a cardiopulmonary medical device company. Prior to Gish, Ms. DAlvise was the CEO of the
Sidney Kimmel Cancer Center (SKCC), a drug discovery research institute. From 1995 until 1998, she was also the
Co-Founder
and Executive VP/COO of Metrika Inc., and in 1999 was the
Co-
Founder/President/CEO/Chairman of NuGEN, Inc. Ms. DAlvise built both companies from technology concept through to successful regulatory approvals, product introduction and sustainable revenue
growth. Prior to 1995, Ms. DAlvise was a VP of Drug Development at Syntex/Roche and Business Unit Director of their Pain and Inflammation business, and also VP of Commercial Operations at SYVA, (Syntexs clinical diagnostics
division), and began her career with Diagnostic Products Corporation. Ms. DAlvise has a B.S. in Biochemistry from Michigan Technological University. She has completed post- graduate work at the University of Michigan, Stanford University,
and the Wharton Business Schools. Ms. DAlvise has served on the board of numerous private companies and
non-profits,
and is an
Entrepreneur-in-Residence
for the von Liebig Institute for Entrepreneurship at the University of California, San Diego.
James S. Hamilton
Mr. Hamilton is currently President and Chief Executive Officer of Neptune. Prior to joining Neptune, from 2006 to 2015,
Mr. Hamilton served as Vice President Human Nutrition and Health, North America, and President of DSM Nutritional Products USA, Inc., based in Parsippany, New Jersey. He was serving on the global management team of DSM Nutritional
Products Human Nutrition & Health business, an organization with over $2 billion in global sales and operations in more than 40 countries. DSM Nutritional Products is an important division of the life sciences and material
sciences corporation, DSM N.V. of the Netherlands. Mr. Hamiltons industry knowledge has made him a valuable contributor to several trade associations and he a director and is the immediate past chairman of the board of directors of the
Council for Responsible Nutrition, the dietary supplement industrys leading trade association. Mr. Hamilton is a graduate of Concordia University in Montreal, Canada and has attended a number of business education and leadership programs
at the London Business School and INSEAD.
Jean-Marie (John) Canan
Mr. Canan is an accomplished business executive with over 34 years of strategic, business development and financial
leadership experience. Mr. Canan recently retired from Merck & Co., Inc. where his last senior position was as Senior Vice-President, Global Controller, and Chief Accounting Officer for Merck from November 2009 to March 2014. He has
managed all interactions with the audit committee of the Merck board of directors, while participating extensively with the main board and the compensation & benefits committee. Mr. Canan serves as a director of REV Group, a public
company, where he chairs the audit committee. Mr. Canan also provides consulting services to Willow BioPharma, a Canadian
start-up,
engaged in the acquisition and development of legacy pharmaceutical assets.
He also serves on the board of trustees of Angkor Hospital for Children, where he also chairs the audit & risk committee. Mr. Canan is a graduate of McGill University, Montreal, Canada, and is a Canadian Chartered Accountant.
Dr. Leendert H. Staal
Dr. Staal is a member of the board of directors of Neptune. He is a seasoned and accomplished senior executive with a
strong track record of value creation. Dr. Staal has held numerous senior level positions within the DSM group, most recently as President and Chief Executive Officer of DSM Nutritional Products from January 2008 to March 2013 and previously as
President and Chief Executive Officer of DSM Pharmaceuticals. Dr. Staal also held the position of Group Vice President of Quest International and was Chairman of Unipath (a wholly owned subsidiary of Unilever). He is currently an independent
consultant and owner of Staal Consulting LLC, focusing on mergers and acquisitions and business strategy. Recently, he has been providing consulting services in connection with Neptunes Sherbrooke plant, where he is part of a team
enhancing and optimizing plant output. Dr. Staal has a Ph.D. in Chemistry from the University of Amsterdam.
65
The following are brief biographies of our senior managers, other than our
President and Chief Financial Officer, Janelle D Alvise, whose biography appears further above:
Linda P. OKeefe
Chief Financial Officer (CFO)
Ms. OKeefe has been our Chief Financial Officer since
November 28, 2016. She has worked with both public and private biotechnology, diagnostics, medical devices and healthcare services firms, and also in other private equity-financed markets, including business services, education and technology.
Prior to joining us, Ms. OKeefe consulted with various firms after serving as Chief Financial Officer and
executive-in-residence
for Gryphon Investors, a San
Francisco-based private equity firm. At Gryphon Investors, she led fundraising, limited partner relations, risk management and advised portfolio company management teams on growth, financing and back office strategies. In addition,
Ms. OKeefe provided mergers & acquisitions and integration support, established and led audit committees, and supported the expansion of teams and systems to meet the needs of growing companies. Ms. OKeefe also served
as Chief Financial Officer of Delphi Ventures, a healthcare-focused venture capital firm, and Elevate Ventures; as Vice President of Finance at Genelabs Technologies and Target Therapeutics; and as Controller at Collagen Corporation.
Ms. OKeefe is an active Certified Public Accountant and Chartered Global Management Accountant in California and Indiana and was formerly an audit senior with Ernst & Young. She is a member of the American Institute of CPAs, the
California and Indiana Societies of CPAs, Association for Corporate Growth, Financial Executives International, and Healthcare Financial Management Association. Ms. OKeefe holds a Bachelor of Science in Business from the University of
California, Berkeley.
Dr. Pierre Lemieux Chief Operating Officer (COO)
Dr. Lemieux has been our Chief Operating Officer since April 12, 2010. He holds a post-doctoral degree in Oncology
from the Health Science Center, University of Texas (San Antonio), USA, and a PhD in biochemistry from Laval University, Canada, jointly with University of Nottingham, England. Prior to joining us, Dr. Lemieux was the President, Chief Executive
Officer and the chairman of the board as well as being the founder of Technologie Biolactis Inc., a late-stage biotechnology company specialized in the commercialization of proteins to better serve the nutraceutical, cosmetic and pharmaceutical
industries. Dr. Lemieux has 20 years of experience in pharmaceutical development and has occupied a variety of high management positions in the pharmaceutical industry.
Mr. Laurent Harvey Vice President, Clinical and
Non-Clinical
Affairs
Mr. Harvey has more than 25 years experience in the biopharmaceutical industry, primarily in drug
development and clinical research. Before joining us, he occupied different management positions at Bristol-Myers Squibb, Æterna-Zentaris, Innodia, Bellus Health and KLOX Technologies. During his career, he participated in many national and
international clinical programs in various therapeutic fields such as cardiovascular, endocrinology, oncology and neurology. Mr. Harvey holds a Bachelors degree in pharmacy and M.Sc. in hospital pharmacy, both from Université de
Montréal.
Summary of our Compensation Programs
Our executive compensation program is intended to attract, motivate and retain high-performing senior executives, encourage and
reward superior performance and align the executives interests with ours by providing compensation which is competitive with the compensation received by executives employed by comparable companies and ensuring that the achievement of annual
objectives is rewarded through the payment of bonuses and providing executives with long-term incentive through the grant of stock options.
Our governance & human resources, or GHR, committee has authority to retain the services of independent compensation
consultants to advise its members on executive compensation and related matters, and to determine the fees and the terms and conditions of the engagement of those consultants. During our fiscal year ended March 31, 2017, the GHR committee
retained compensation consulting services, including those led by Lockton Companies, to review our executive compensation programs, including base salary, short-term and long-term incentives, total cash compensation levels and total direct
compensation of certain senior positions, against those of peer groups of similar and larger size, as
66
measured by market capitalization, biotechnology and pharmaceutical companies listed or headquartered in North America.
All of the services provided by the consultants were provided to the
GHR committee. The GHR committee assessed the independence of the consultants and concluded that its engagement of the consultants did not raise any conflict of interest with us or any of our directors or executive officers. As influenced by the
consultants fiscal period 2017 executive compensation review, the board and GHR committee set the following executive compensation program.
Use of Fixed and Variable Pay Components
Compensation of NEOs is revised each year and has been structured to encourage and reward executive officers on the basis of
short-term and long-term corporate performance. In the context of its analysis of compensation for our fiscal year ended March 31, 2017, the following components were examined by the GHR committee:
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short term incentive plan, consisting of a cash bonus;
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long term incentive plan, consisting of stock options and equity incentive grants based on performance and/or
time vesting conditions; and
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other elements of compensation, consisting of group benefits and perquisites.
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Base Salary
We intend to be competitive with comparator companies and to attract and retain top talent. The GHR committee will review
compensation periodically to be sure it meets this strategic imperative. Base salary is set to reflect an individuals skills, experience and contributions within a salary structure consistent with our gender pay equity policy
.
Base salary structure is revised annually by the GHR committee as our financial and market conditions evolve.
Short Term
Incentive Plan (STIP)
Our Short-Term Incentive Plan, or STIP, provides for potential rewards when a threshold
of corporate performance is met. Personal objectives that support corporate goals are established annually with each employee and are assessed at the end of each financial year. Personal objectives are assessed through a performance grid, with
pre-specified,
objective performance criteria. STIP awards are paid out in proportion to individual performance, determined in
end-of-year
performance reviews. For the most senior participants in the STIP, greater weight is assigned to corporate objectives. Target payout is expressed as a
percentage of base salary and is determined by employment contracts and board discretion. Annual salary for STIP purposes is the annual salary in effect at the end of the plan year (i.e., prior to annual salary increases).
The actual amount awarded ranges from zero for performance well below expectation and is capped at two times target for
exceptional performance. The STIP is a discretionary variable compensation plan and all STIP payments are subject to board approval. Participants must be employed by us at the end of the financial year to qualify. We reserve the right to modify or
discontinue the STIP at any time.
Ms. DAlvise, our CEO, is eligible for up to a 50% bonus of her annual base
salary and Ms. OKeefe, our CFO, is eligible for up to a 40% bonus of her annual base salary. Dr. Lemieux, our COO, is eligible for up to a 40% bonus of his annual base salary and Mr. Harvey, Vice President, Clinical and
Non-Clinical
Affairs, is eligible for up to a 30% bonus of his annual base salary.
These
performance goals will take into account the achievement of R&D milestones within timelines and budget and individual objectives determined annually by the board according to short-term priorities.
Long Term Incentive Plan (LITP)
The LTIP has been adopted as a reward and retention mechanism. Participation is determined annually at the discretion of the
board. Employees approved by our board of directors may participate in our stock option plan, which is designed to align the long-term interests of participants with those of shareholders, in order to promote shareholder value.
67
The GHR committee determines the number of stock options to be granted to a
participant based on peer group data and taking into account corporate performance and level in the organization. The LTIP calculation is based on a guideline percentage of base salary and the number of options is determined based on an approved
dollar value (rather than a specific number of shares). The guideline ranges from 15% to 200% and is subject to adjustment by the board in reviewing annual achievement of corporate performance and availability of shares. The GHR committee may also
determine, in its sole discretion,
ad hoc
stock option awards to be granted to participants in order to address extraordinary situations. Awards at any level may be adjusted as necessary to maintain an equity burn rate and overhang similar to
comparator companies. In addition to our stock option plan, the board is also empowered to grant
ad hoc
awards, from time to time, under our equity incentive plan to provide for a share-related mechanism to attract, retain and motivate
qualified directors, senior employees and consultants.
Our directors and executive officers are not permitted to purchase
financial instruments, such as prepaid variable forward contracts, equity swaps, collars or units of exchange funds that are designed to hedge or offset a decrease in market value of equity securities granted as compensation or held, directly or
indirectly, by the director or officer.
Share Ownership Guidelines
To further align the interests of our executives with those of our other shareholders, the board has adopted share ownership
guidelines. Under these guidelines, the CEO and other executives (i.e., CFO, COO, VPs) are required to retain and hold 50% of the shares acquired by them under any equity incentive award granted on or after June 8, 2017 (after subtracting
shares sold to pay for option exercise costs, and relevant federal, state, and local taxes which are assumed to be at the highest marginal tax rates). In addition, the share retention rule applies unless the executive beneficially owns shares with a
value at or in excess of the following share ownership guidelines:
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CEO 2x then-current annual base salary
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Other executives 1x then-current annual base salary.
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The value of an individuals shares for purposes of the share ownership guidelines is deemed to be the greater of the
then-current fair market value of the shares, or the individuals cost basis in the shares. Shares counted in calculating the share ownership guidelines include shares beneficially owned outright, whether from open market purchases, shares
retained after option exercises, and shares of restricted stock or deferred stock units that have fully vested. In addition, in the case of vested, unexercised,
in-the-money
stock options, the
in-the-money
value of the stock options will be included
in the share ownership calculation. Executives have five years from their date of hire or promotion to satisfy the share ownership guidelines.
Stock Option Plan
Our stock option plan was adopted by our board of directors on October 8, 2008 and has been amended from time to time,
including most recently on June 14, 2017. The grant of options is part of the long-term incentive component of executive and director compensation and an essential part of compensation. Qualified directors, employees and consultants may
participate in our stock option plan, which is designed to encourage optionnees to link their interests with those of our shareholders, in order to promote an increase in shareholder value. Awards and the determination of any exercise price are made
by our board of directors, after recommendation by the GHR committee. Awards are established, among other things, according to the role and responsibilities associated with the participants position and his or her influence over appreciation
in shareholder value. Any award grants a participant the right to purchase a certain number of common shares during a specified term in the future, after a vesting period and/or specific performance conditions, at an exercise price equal to at least
100% of the market price (as defined below) of our common shares on the grant date. The market price of common shares as of a particular date generally means the closing price per common share on the TSXV, or any other exchange on which
the common shares are listed from time to time, for the last preceding date on which there was a sale of common shares on that exchange (subject to certain exceptions set forth in the stock option plan in the event that we are no longer traded on
any stock exchange). Previous awards may sometimes be taken into account when new awards are considered.
In accordance
with the stock option plan, all of an option holders options will immediately vest on the date of a Change of Control event (as defined in the stock option plan), subject to the terms of any employment agreement or other contractual
arrangement between the option holder and us.
68
However, in no case will the grant of options under the plan, together with any
proposed or previously existing security based compensation arrangement, result in (in each case, as determined on the grant date): the grant to any one consultant within any
12-month
period, of options
reserving for issuance a number of common shares exceeding in the aggregate 2% of our issued and outstanding common shares (on a
non-diluted
basis); or the grant to any one employee, which provides investor
relations services, within any
12-month
period, of options reserving for issuance a number of common shares exceeding in the aggregate 2% of our issued and outstanding common shares (on a
non-diluted
basis).
Options granted under the stock option plan are
non-transferable
and are subject to a minimum vesting period of 18 months, with gradual and equal vesting on no less than a quarterly basis. They are exercisable, subject to vesting and/or performance conditions, at
a price equal to the closing price of the common shares on the TSXV on the day prior to the grant of such options. In addition, and unless otherwise provided for in the agreement between us and the holder, options will also lapse upon termination of
employment or the end of the business relationship with us except that they may be exercised for 60 days after termination or the end of the business relationship (30 days for investor relations services employees), to the extent that they will have
vested on such date of termination of employment, except in the case of death, disability or retirement where this period is extended to 12 months.
Subject to the approval of relevant regulatory authorities, including the TSXV, if applicable, and compliance with any
conditions attached to that approval (including, in certain circumstances, approval by disinterested shareholders) if applicable, the board of directors has the right to amend or terminate the stock option plan. However, unless option holders
consent to the amendment or termination of the stock option plan in writing, any such amendment or termination of the stock option plan cannot affect the conditions of options that have already been granted and that have not been exercised under the
stock option plan.
Options for common shares representing a fixed rate of 20% of our outstanding issued common shares as
of February 29, 2016 may be granted by the board under the stock option plan. As at the March 31, 2017, there were 657,619 common shares reserved for issuance under the stock option plan. As of March 31, 2017, there were 1,424,788
options outstanding under the stock option plan. On June 14, 2017, in connection with amendments to the stock option plan discussed below, the board granted 1,021,500 stock options to employees, executives and members of the board, of which
373,600 of these stock options are subject to shareholder approval at our next annual general and special shareholders meeting.
On June 14, 2017, the board approved amendments to the existing limits for common shares reserved for issuance under the
stock option plan as described below, which are subject to shareholder approval. At our next annual and special shareholders meeting, shareholders will be asked to consider a resolution to approve amendments to the equity incentive plan to set the
total number of common shares reserved for issuance pursuant to awards granted under the equity incentive plan to an aggregate number that:
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if, and for so long as the common shares are listed on the TSXV, will not exceed the lower of:
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367,563 Common Shares, and
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20% of the issued and outstanding common shares as of March 31, 2017, (equating to 2,940,511 common shares), which number will include common shares issuable pursuant to options issued under the amended stock
option plan; or
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if, and for so long as the common shares are listed on the TSX, will not exceed 2.5% of the issued and outstanding common shares from time to time.
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The proposed amendments would also change certain limits to the number of common shares that can be reserved for issuance for
specific grants.
Equity Incentive Plan
On May 22, 2013, our equity incentive plan was adopted by the board in order to, among other things, provide us with a
share-related mechanism to attract, retain and motivate qualified directors, employees and consultants. The adoption of the equity incentive plan was initially approved by shareholders at our 2013 Shareholders meeting held on June 27,
2013.
Eligible persons may participate in the equity incentive plan. Eligible persons under the equity
incentive plan consist of any director, officer, employee or consultant (as defined in the equity incentive plan) of us or a subsidiary. A participant is an eligible person to whom an award has been granted under the equity incentive plan. The
equity incentive plan provides us with the option to grant to eligible persons bonus shares, restricted shares, restricted share units, performance share units, deferred share units and other share-based awards.
69
If, and for so long as our common shares are listed on the TSXV, no more than 2%
of the issued and outstanding common shares may be granted to any one consultant or employee conducting investor relations activities in any
12-month
period.
The board has the right to determine that any unvested or unearned restricted share units, deferred share units, performance
share units or other share-based awards or restricted shares subject to a restricted period outstanding immediately prior to the occurrence of a change in control will become fully vested or earned or free of restriction upon the occurrence of a
change in control. The board may also determine that any vested or earned restricted share units, deferred share units, performance share units or other share-based awards will be cashed out at the market price as of the date a change in control is
deemed to have occurred, or as of such other date as the board may determine prior to the change in control. Further, the board has the right to provide for the conversion or exchange of any restricted share unit, deferred share unit, performance
share unit or other share-based award into or for rights or other securities in any entity participating in or resulting from the change in control.
The equity incentive plan is administered by the board and the board has sole and complete authority, in its discretion, to
determine the type of awards under the equity incentive plan relating to the issuance of common shares (including any combination of bonus shares, restricted share units, performance share units, deferred share units, restricted shares or other
share-based awards) in such amounts, to such persons and under such terms and conditions as the board may determine, in accordance with the provisions of the equity incentive plan and the recommendations made by the GHR committee.
Subject to the adjustment provisions provided for in the equity incentive plan and the applicable rules and regulations of all
regulatory authorities to which we are subject (including any stock exchange), the total number of common shares reserved for issuance pursuant to awards granted under the equity incentive plan will be equal to a number that (A) if, and for so
long as the common shares are listed on the TSXV, will not exceed either (i) 267,800 common shares, and (ii) 20% of the issued and outstanding common shares as of February 29, 2016, representing 2,142,407 common shares, which includes common
shares issuable pursuant to options issued under our stock option plan.
On June 14, 2017, the board approved
amendments to the existing limits of common shares reserved for issuance under the stock option plan as described above, which are subject to shareholder approval.
Other Forms of Compensation
RRSP Matching Program.
Effective June 1, 2016, we sponsor a voluntary Registered Retirement Savings Plan, or RRSP,
matching program, which is open to all eligible employees, including NEOs. The RRSP matching program matches employees contributions up to a maximum of $1,000 per fiscal year for eligible employees who participate in the program. Other than
matching contributions under the RRSP matching program (which amounts are disclosed in the column entitled All Other Compensation in the summary compensation table below), we do not provide pension or retirement benefits to our executive
officers or directors.
Other Benefits and
Perquisites.
Our executive employee benefit program also includes
life, medical, dental and disability insurance. These benefits and perquisites are designed to be competitive overall with equivalent positions in comparable organizations. We do not have a pension plan for employees.
70
Compensation Paid to Named Executive Officers
The following table sets forth the compensation information for the NEOs during the thirteen months ended March 31, 2017,
and the fiscal years ended February 29, 2016 and February 28, 2015.
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Name and
Principal Position
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Period
ended
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Salary
($)
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Share-
Based
Awards
(1)(2)
($)
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Option-Based
Awards
(1) (2)
($)
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Annual
Incentive
Plans
($)
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All
Other
Compensation
($)
(3)
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Total
Compensation
($)
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Janelle DAlvise
(4)
CEO
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March 31,
2017
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365,072
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-
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502,163
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136,049
(6)
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-
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1,003,284
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Linda P.
OKeefe
(5)
CFO
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March 31,
2017
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114,183
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-
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237,340
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39,897
(7)
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109,414
(8)
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500,834
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Pierre Lemieux
COO
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March 31,
2017
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275,819
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-
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96,522
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49,000
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-
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421,341
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February 29,
2016
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239,565
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-
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33,320
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|
42,000
|
|
-
|
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314,885
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February 28,
2015
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202,115
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-
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22,163
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12,000
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-
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236,278
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Laurent Harvey
Vice President,
Clinical and
Non-
Clinical Affairs
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March 31,
2017
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194,846
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-
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84,205
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35,000
|
|
-
|
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314,051
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|
February 29,
2016
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|
159,808
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|
-
|
|
17,153
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|
16,000
|
|
-
|
|
192,961
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|
February 28,
2015
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|
107,977
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-
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7,388
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8,000
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-
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123,365
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(1)
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We have adopted IFRS 2 Share-Based Payment to account for the issuance of stock options to employees and
non-employees.
The fair value of stock options is estimated at the grant date using the Black-Scholes option pricing model. This model requires the input of a number of parameters, including share price, share
exercise price, expected share price volatility, expected time until exercise and risk-free interest rates. Although the assumptions used reflect managements best estimates, they involve inherent uncertainties based on market conditions
generally outside of our control.
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(2)
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The fair value of the option-based awards granted in the thirteen-month period ended March 31, 2017 is as
follows: (i) the May 12, 2016 option-based awards are based on a fair value of $0.96 per option granted to Ms. DAlvise; (ii) the May 30, 2016 option-based awards are based on a fair value of $1.18 per option granted to
Dr. Lemieux and Mr. Harvey; (iii) the February 24, 2017 option-based awards are based on a fair value of $1.19 per option granted to Ms. OKeefe and Dr. Lemieux and Mr. Harvey.
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For the period ended on February 29, 2016, the fair market value of the June 1, 2015 option-based awards are based on
a fair value of $1.97 per option granted to Messrs. Harvey and Lemieux.
For the period ended on February 28, 2015, the
fair market value of the October 20, 2014 option-based awards granted to Dr. Lemieux is based on a fair value of $3.00 per option, prior to our reverse share split.
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(3)
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The value of perquisites and other personal benefits received by these executives did not total an aggregate
value of $50,000 or more, and does not represent 10% or more of their total salary during the financial years ended March 31, 2017, February 29, 2016 and February 28, 2015.
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(4)
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Ms. DAlvise was appointed our President and CEO on May 11, 2016 and began her functions on
June 1, 2016. Her employment agreement provides for payments in U.S. dollars with an annual base salary of US$330,000.
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(5)
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Ms. OKeefe was appointed our CFO effective as of November 27, 2016. Her employment agreement
provides for payments in U.S. dollars with an annual base salary of US$250,000.
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(6)
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US$102,300, converted as at March 31, 2017, based on a closing exchange rate of US1.00= $1.3299.
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(7)
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US$30,000 converted as at March 31, 2017, based on a closing exchange rate of US1.00= $1.3299.
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(8)
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Consulting services from July 2016 to November 2016 which provided for payments in U.S. dollars: US$82,273,
converted as at March 31, 2017 based on a closing exchange rate of US1.00= $1.3299.
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71
Outstanding Share-Based and Option-Based Awards
The following tables provide information about the number and value of the outstanding option-based awards held by the
NEOs
as of March 31, 2017. There are no share-based awards outstanding as of the date of this annual report.
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Name / Grant Date
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Number of Securities
Underlying
Unexercised Options
(#)
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Option Exercise
Price ($)
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Option Expiration
Date
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Value of Unexercised
In-The-Money
Options
(1)
($)
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Janelle DAlvise
(2)
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May 12, 2016
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525,000
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1.56
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May 12, 2023
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141,750
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Linda P. OKeefe
(3)
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February 24, 2017
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200,000
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1.65
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February 24, 2027
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36,000
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Pierre Lemieux
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February 24, 2017
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50,000
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|
1.65
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|
February 24, 2027
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9,000
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May 30, 2016
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|
31,400
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|
1.99
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|
May 29, 2023
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-
|
June 1, 2015
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16,900
(1)
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|
4.50
(1)
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June 1, 2022
|
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-
|
October 20, 2014
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|
7,500
(1)
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|
6.50
(1)
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October 19, 2019
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-
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Laurent Harvey
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February 24, 2017
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50,000
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|
1.65
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|
February 24, 2027
|
|
9,000
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May 30, 2016
|
|
21,000
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|
1.99
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|
May 29, 2023
|
|
-
|
June 1, 2015
|
|
8,700
(1)
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|
4.50
(1)
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June 1, 2022
|
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-
|
October 20, 2014
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|
2,500
(1)
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|
6.50
(1)
|
|
October 19, 2019
|
|
-
|
|
(1)
|
Calculation is based on a trading price of $1.83 for our common shares on the TSXV, as at closing on
March 31, 2017.
|
|
(2)
|
Ms. DAlvise was appointed as our President and CEO on May 11, 2016 and began her functions on
June 1, 2016.
|
|
(3)
|
Ms. OKeefe was appointed as our CFO effective November 27, 2016.
|
The following table sets out the value of share-based, option-based, and warrant-based awards held by the NEOs that vested
during the fiscal year ended March 31, 2017:
|
|
|
|
|
Name
|
|
Share-Based Awards
($)
|
|
Option-Based Awards
($)
|
Janelle DAlvise
|
|
-
|
|
28,875
|
Compensation of Directors
Our directors compensation consists of an annual fixed compensation of US$35,000. While our compensation structure does
not include meeting fees, a discretionary reduction of 20% may be applied to the annual retainer payment each time a director fails to attend a quarterly board or committee session. In addition, the chairman of the board and each chairperson of the
audit and the GHR committees received additional compensation of US$25,000 and US$10,000, respectively, for their additional work during the fiscal year ended March 31, 2017.
The directors are also entitled to be reimbursed for
travelling and other reasonable expenses properly incurred by them in attending meetings of the board or any committee or in otherwise serving us, in accordance with our policy on travel and expenses.
Following their first election to our board of directors,
non-executive
directors are
eligible to receive an initial equity grant of up to 150% of their annual cash retainer worth of stock options vesting annually in equal installments over a
3-year
period, subject to the other terms and
conditions set forth under the heading Stock Option Plan. In addition to their initial grant,
non-executive
directors are eligible to receive an annual equity-based award equal to 100% of
their total annual cash retainer vesting quarterly in equal installments over an
18-month
period. These awards will be granted at the same time that we are performing our annual performance review for our
employees, subject to availability of common shares and subject to the terms and conditions described under the headings Stock Purchase Plan and Equity Incentive Plan. The level of these awards will be consistent
with equivalent awards in comparable companies obtained from the benchmark exercise and in accordance with the recommendations obtained from our independent compensation consultant.
72
The total compensation for our
non-executive
directors during the thirteen-month period ended March 31, 2017 was as follows:
|
|
|
|
|
|
|
|
|
|
|
Name
|
|
Thirteen
Months
Ended March
31
|
|
Fees Earned
($)
|
|
Option-Based
Awards
(1)(2)
($)
|
|
All Other
Compensation
($)
(5)
|
|
Total
($)
|
|
|
|
|
|
|
Roderick N.
Carter
|
|
2017
|
|
188,517
(3)
|
|
236,860
|
|
-
|
|
425,377
|
|
|
|
|
|
|
Jean-Marie
(John) Canan
|
|
2017
|
|
44,884
(4)
|
|
58,520
|
|
-
|
|
103,404
|
|
|
|
|
|
|
James
S.
Hamilton
|
|
2017
|
|
-
|
|
-
|
|
-
|
|
-
|
|
|
|
|
|
|
Leendert H.
Staal
(6)
|
|
2017
|
|
44,884
(4)
|
|
58,520
|
|
-
|
|
103,404
|
|
|
|
|
|
|
Pierre
Fitzgibbon
(6)
|
|
2017
|
|
21,917
|
|
-
|
|
-
|
|
21,917
|
|
(1)
|
We have adopted IFRS 2 Share-Based Payment to account for the issuance of stock options to employees and
non-employees.
The fair value of the awards is estimated at the grant date using the Black-Scholes option pricing model. This model requires the input of a number of parameters, including share price, share exercise
price, expected share price volatility, expected time until exercise and risk-free interest rates. Although the assumptions used reflect managements best estimates, they involve inherent uncertainties based on market conditions generally
outside of our control.
|
|
(2)
|
For the thirteen-month period ended on March 31, 2017, (i) the fair market value of the May 30, 2016
option-based awards is based on a fair value of $1.18 per option granted to Dr. Carter; and (ii) the fair market value of the February 24, 2017 option-based awards is based on a fair value of $1.17 per option granted to Mr. Canan and Dr. Staal.
|
|
(3)
|
Dr. Carter was appointed Executive Chairman of the board on March 1, 2016 and earned compensation of
US$98,980 for this role through June 30, 2016. After that date and Ms. DAlvises appointment as CEO on June 1, 2016, Dr. Carter earned compensation of US$45,000 for being Chairman of the board through March 31,
2017.
|
|
(4)
|
Mr. Canan and Dr. Staal earned a director compensation of US$33,750 and were appointed to the board
of directors in July 2016.
|
|
(5)
|
The directors do not receive pension benefits or other
non-equity
based
annual compensation.
|
|
(6)
|
After the resignation of certain directors on February 29, 2016, Mr. Fitzgibbon, Chairman of the
board of directors of Neptune, joined until July 12, 2016 as member of our board of directors and Chair of the audit and GHR committees to help insure a proper transition between the departing directors and the election of the new nominees at
our 2016 annual general shareholders meeting.
|
73
Outstanding Share-Based and Option-Based Awards for Directors
The following table provides information about the number and value of the outstanding share-based and option-based awards held
by
non-executive
directors. There were no share-based awards outstanding as of the date of this annual report.
|
|
|
|
|
|
|
|
|
Name / Grant Date
|
|
Number of Securities
Underlying
Unexercised Options
|
|
Option Exercise
Price ($)
(1)
|
|
Option Expiration Date
|
|
Value of Unexercised
in-the-Money
Options
($)
(2)
|
Roderick N. Carter
|
May 30, 2016
|
|
200,000
|
|
1.99
|
|
May 29, 2023
|
|
-
|
August 19, 2015
|
|
10,000
(1)
|
|
4.80
|
|
August 19, 2022
|
|
-
|
Jean-Marie (John) Canan
|
February 24, 2017
|
|
50,000
|
|
1.65
|
|
February 24, 2027
|
|
9,000
|
Leendert H. Staal
|
February 24, 2017
|
|
50,000
|
|
1.65
|
|
February 24, 2027
|
|
9,000
|
|
|
|
|
|
|
|
|
|
(1) Option-based awards were consolidated following our share consolidation. The
exercise price was increased proportionally to reflect the consolidation.
(2) Calculation is based on a trading price of $1.83 for our common shares on
the TSXV, as at closing on March 31, 2017.
|
None of the share-based and stock options of the Corporation held by
non-executive
Directors that vested during the financial year ended on March 31, 2017 were
in-the-money
at their respective
vesting date.
Board of Directors
Director Independence
Our board of directors believes that, in order to maximize its effectiveness, the board must be able to operate independently.
A majority of directors must satisfy the applicable tests of independence, such that the board of directors complies with all independence requirements under applicable corporate and securities laws and stock exchange requirements applicable to us.
No director will be independent unless the board of directors has affirmatively determined that the director has no material relationship with us or any of our affiliates, either directly or indirectly or as a partner, shareholder or officer of an
organization that has a relationship with us or our affiliates. Such determinations will be made on an annual basis and, if a director joins the board of directors between annual meetings, at such time.
Independent Directors
The board of directors determined that Mr. Canan, Dr. Carter and Dr. Staal are independent within the meaning of
NI
52-110
and NASDAQ Stock Market rules.
Directors Who are Not Independent
The board of directors determined that Mr. Hamilton is not independent within the meaning of NI
52-110
and NASDAQ rules given that he is President and CEO of Neptune.
In addition, the board of directors determined that Ms. DAlvise is not independent within the meaning of NI
52-110
and NASDAQ given that she is our President and CEO.
74
Attendance Record of Directors for Board Meetings
During the fiscal year ended March 31, 2017, the board of directors held 12 meetings. Attendance of directors at those
meetings is indicated in the table below:
|
|
|
Board Members
|
|
Attendance
|
Roderick N. Carter
|
|
12/12
|
Jean-Marie
(John) Canan
(1)
|
|
8/8
|
Janelle DAlvise
(1)
|
|
8/8
|
James S.
Hamilton
|
|
12/12
|
Leendert H. Staal
(1)
|
|
8/8
|
Pierre Fitzgibbon
(2)
|
|
4/4
|
|
(1)
|
Ms. DAlvise, Mr. Canan and Dr. Staal joined the board of director at our last annual
general meeting on July 12, 2016.
|
|
(2)
|
Mr. Fitzgibbon was temporarily appointed as a member of the board from March 1, 2016 to July 12,
2016 following the resignation of certain directors.
|
During the fiscal year ended March 31, 2017,
the independent directors held at least 5 scheduled meetings at which
non-independent
directors and members of management were not in attendance.
Chairman of the Board
Dr. Carter acts as Chairman of the board. His duties and responsibilities consist of the oversight of the quality and
integrity of the board of directors practices
.
Board Mandate
There is no specific mandate for the board of directors, since the board has plenary power. Any responsibility that is not
delegated to senior management or a committee of the board remains with the full board of directors.
Position Descriptions
No written position description has been approved for the chair of the board of directors and for the chairs of each committee.
The primary role and responsibility of the chair of each committee of the board of directors is to: (i) in general, ensure that the committee fulfills its mandate, as determined by the board of directors; (ii) chair meetings of the
committee; (iii) report to the board of directors; and (iv) act as liaison between the committee and the board of directors and, if necessary, our management.
Orientation and Continuing Education
We provide orientation for new appointees to the board of directors and committees in the form of informal meetings with
members of the board and senior management, complemented by presentations on the main areas of our business. The board does not formally provide continuing education to its directors, as directors are experienced members. The board of directors
relies on professional assistance, when judged necessary, in order to be educated/updated on a particular topic.
Code of Business Conduct and
Ethics
The board of directors adopted a Code of Business Conduct and Ethics, or Code of Conduct, for our
directors, officers and employees on May 31, 2007, as amended from time to time. Our Code of Conduct can be found on SEDAR at www.sedar.com and on our web site on www.acastipharma.com. A copy of the Code of Conduct can also be obtained by
contacting our Corporate Secretary. Since its adoption by the board of directors, any breach of the Code of Conduct must be brought to the attention of the board of directors by our CEO or other senior executives. No report has ever been filed which
pertains to any conduct of a director or executive officer that constitutes a breach to our Code of Conduct.
75
Since the adoption of the Code of Conduct and the following policies, the board
of directors actively monitors compliance with the Code Conduct and promotes a business environment where employees are encouraged to report malfeasance, irregularities and other concerns. The Code of Conduct provides for specific procedures for
reporting
non-compliant
practices in a manner which, in the opinion of the board of directors, encourages and promotes a culture of ethical business conduct.
The board of directors also adopted a disclosure policy, insider trading policy, majority voting policy, management and board
compensation policies, and a whistleblower policy.
In addition, under the
Civil
Code of
Québec,
to which we are subject as a legal person incorporated under the
Business Corporations Act
(Québec) (L.R.Q., c.
S-31),
a director o must immediately disclose to the
board any situation that may place him or her in a conflict of interest. Any such declaration of interest is recorded in the minutes of proceeding of the board of directors. The director abstains, except if required, from the discussion
and voting on the question. In addition, it is our policy that an interested director recuse himself or herself from the decision-making process pertaining to a contract or transaction in which he or she has an interest.
Nomination of Directors
The board of directors receives recommendations from the
GHR committee, but retains responsibility for managing its own
affairs by, among other things, giving its approval for the composition and size of the board of directors, and the selection of candidates nominated for election to the board of directors. The GHR committee initially evaluates candidates for
nomination for election as directors, having regard to the background, employment and qualifications of possible candidates.
The selection of the nominees for the board of directors is made by the other members of the board, based on our needs and the
qualities required for the board of directors, including ethical character, integrity and maturity of judgment of the candidates; the level of experience of the candidates, their ideas regarding the material aspects of our business, the expertise of
the candidates in fields relevant to us while complementing the training and experience of the other members of the board of directors; the will and ability of the candidates to devote the necessary time to their duties to the board of directors and
its committees, the will of the candidates to serve on the board of directors for numerous consecutive financial periods and finally, the will of the candidates to refrain from engaging in activities which conflict with the responsibilities and
duties of a director. The board researches the training and qualifications of potential new directors which seem to correspond to the selection criteria of the board of directors and, depending on the results of said research, organizes meetings
with the potential candidates.
In the case of incumbent directors whose terms of office are set to expire, the board will
review such directors overall service to us during their term of office, including the number of meetings attended, level of participation, quality of performance and any transactions of such directors with us during their term of office.
We may use various sources in order to identify the candidates for the board of directors, including our own contacts and the
references of other directors, officers, advisors and executive placement agencies. We will consider director candidates recommended by shareholders and will evaluate those director candidates in the same manner in which we evaluate candidates
recommended by other sources. In making recommendations for director nominees for the annual meeting of shareholders, we will consider any written recommendations of director candidates by shareholders received by our Corporate Secretary not later
than 120 days before the anniversary of the previous years annual meeting of shareholders. Recommendations must include the candidates name, contact information and a statement of the candidates background and qualifications, and
must be mailed to us. Following the selection of the candidates by the board of directors, we will propose a list of candidates to the shareholders, for our annual meeting of shareholders.
The board of directors does not have a nominating committee and has not adopted any formal written director term limit policy.
Proposed nominations of director candidates are evaluated by our GHR committee.
GHR Committee
The mandate of the GHR committee consists of the evaluation of the proposed nominations of senior executives and director
candidates to our board of directors,
recommending for board approval, if appropriate, revisions of our corporate governance practices and procedures, developing new charters for any new committees established by the board of directors,
monitoring relationships and communication between management and the board of directors, monitoring emerging best practices in corporate governance and oversight of governance matters and assessing the board of directors and its committees. The GHR
committee is also in charge of establishing the procedure which must be followed by us to comply with applicable guidelines of the TSXV and NASDAQ Stock Market regarding corporate governance.
76
The GHR committee has the responsibility of evaluating the compensation,
performance incentives as well as the benefits granted to our upper management in accordance with their responsibilities and performance as well as to recommend the necessary adjustments to our board of directors. The GHR committee also reviews the
amount and method of compensation granted to the directors. The GHR committee may retain an external firm in order to assist it during the execution of its mandate. The GHR committee considers time commitment, comparative fees and responsibilities
in determining compensation.
The GHR committee is composed of independent members within the meaning of NI
52-110
and NASDAQ Stock Exchange rules, namely Dr. Staal, acting as chairperson, Dr. Carter and Mr. Canan.
Periodic Assessments
The board of directors, its committees and each director are subject to periodic evaluations of their efficacy and
contribution. The evaluation procedure consists in identifying any shortcomings and implementing adjustments proposed by directors at the beginning and during meetings of the board of directors and of each of its committees. Among other things,
these adjustments deal with the level of preparation of directors, management and consultants employed by us, the relevance and sufficiency of the documentation provided to directors and the time allowed to directors for discussion and debate of
items on the agenda.
Director Term Limits
The board actively considers the issue of term limits from time to time. At this time, the board does not believe that it is in
our best interests to establish a limit on the number of times a director may stand for election. While such a limit could help create an environment where fresh ideas and viewpoints are available to the board, a director term limit could also
disadvantage us through the loss of the beneficial contribution of directors who have developed increasing knowledge of, and insight into, us and our operations over a period of time. As we operate in a unique industry, it is difficult to find
qualified directors with the appropriate background and experience and the introduction of a director term limit would impose further difficulty.
Policies Regarding the Representation of Women on the Board and Among Executive Officers
We have not adopted a formal written policy regarding diversity amongst executive officers and members of the board of
directors, including mechanisms for board renewal, in connection with, among other things, the identification and nomination of women directors. Nevertheless, we recognize that gender diversity is a significant aspect of diversity and acknowledges
the important role that women with appropriate and relevant skills and experience can play in contributing to the diversity of perspective on the board of directors.
Rather than considering the level of representation of women for directorship and executive officer positions when making board
or executive officer appointments, we consider all candidates based on their merit and qualifications relevant to the specific role. While we recognize the benefits of diversity at all levels within its organization, we do not currently have any
targets, rules or formal policies that specifically require the identification, consideration, nomination or appointment of candidates for directorship or executive management positions or that would otherwise force the composition of our board of
directors and executive management team. Currently, we have one women director who is also our CEO. In addition, our CFO is a woman.
Audit Committee
Our audit committee is responsible for assisting the board of directors in fulfilling its oversight
responsibilities with respect to financial reporting, including:
|
|
|
reviewing our procedures for internal control with our auditor and management performing financial functions;
|
|
|
|
reviewing and approving the engagement of the auditor;
|
|
|
|
reviewing annual and quarterly financial statements and all other material continuous disclosure documents,
including our annual information form and managements discussion and analysis;
|
|
|
|
assessing our financial and accounting personnel;
|
|
|
|
assessing our accounting policies;
|
77
|
|
|
reviewing our risk management procedures; and
|
|
|
|
reviewing any significant transactions outside our ordinary course of business and any pending litigation
involving us.
|
The audit committee has direct communication channels with our management performing
financial functions and our external auditor to discuss and review such issues as the audit committee may deem appropriate. As of March 31, 2017, the audit committee is composed of Mr. Canan, as chairperson, Dr. Carter and
Dr. Staal. Each is financially literate and independent within the meaning of NI
52-110
and the Exchange Act.
Compensation Governance
Compensation of our executive officers and directors is recommended to the board of directors by the GHR committee. In its
review process, the GHR committee relies on input from management on the assessment of executives and corporate performance. During the fiscal year ended March 31, 2017, the GHR committee was composed of the following members, each of whom
is independent: Dr. Staal, acting as chairperson, Dr. Carter and Mr. Canan. The GHR committee establishes management compensation policies and oversees their general implementation. All members of the GHR committee have direct
experience which is relevant to their responsibilities as GHR committee members. All members are or have held senior executive or director roles within significant businesses, several also having public companies experience, and have a good
financial understanding which allows them to assess the costs versus benefits of compensation plans. The members combined experience in our sector provides them with the understanding of our success factors and risks, which is very important when
determining metrics for measuring success.
Risk management is a primary consideration of the GHR committee when
implementing its compensation program. We do not believe that our compensation program results in unnecessary or inappropriate risk taking, including risks that are likely to have a material adverse effect on us. Payments of bonuses, if any, are not
made unless performance goals are met.
For executives, more than half of target direct compensation (base salary + target
STIP awards + target LTIP awards) is considered at risk. We believe this mix results in a strong
pay-for-performance
relationship and an alignment with
shareholders and is competitive with other firms of comparable size in similar fields. The CEO (or any person acting in that capacity) makes recommendations to the GHR committee as to the compensation of our executive officers, other than himself or
herself, for approval by the board. The GHR committee makes recommendations to the board of directors as to the compensation of the CEO, for approval. The CEOs salary is based on comparable market consideration and the GHR committees
assessment of his or her performance, with regard to our financial performance and progress in achieving strategic goals.
Qualitative factors beyond the quantitative financial metrics are also a key consideration in determination of individual
executive compensation payments. How executives achieve their financial results and demonstrate leadership consistent with our values are key to individual compensation decisions.
Our management consists of professionals experienced
in business development, finance and science. Our research team includes scientists with expertise in pharmaceutical development, chemistry, manufacturing and controls, nonclinical and clinical studies, pharmacology, regulatory affairs, quality
assurance/quality control, intellectual property and strategic alliances. As of March 31, 2017, we had 13 full-time employees located in Canada and 2 full-time employees located in the United States. We generally require all of our employees to
enter into an invention assignment,
non-disclosure
and
non-compete
agreement. We rely, in part, on the administrative and other staff of Neptune and also rely on
consultants from time to time. Our employees are not covered by any collective bargaining agreement or represented by a trade union. We consider our relations with our employees to be good and our operations have never been interrupted as the result
of a labor dispute.
78
The following table shows the total number of
common shares beneficially owned by each of our directors and executive officers and the percentage of the total issued and outstanding common shares that such holdings represent.
|
|
|
|
|
Name
|
|
Common shares beneficially owned
as of March 31, 2017
|
|
Percentage of total issued and
outstanding common shares
as of March 31, 2017
(1)
|
Roderick N. Carter
|
|
-
|
|
-
|
Jean-Marie (John) Canan
|
|
57,500
|
|
*
|
James S. Hamilton
|
|
-
|
|
-
|
Leendert H. Staal
|
|
-
|
|
-
|
Janelle DAlvise
|
|
52,500
|
|
*
|
Linda P. OKeefe
|
|
30,000
|
|
*
|
Pierre Lemieux
|
|
7,000
|
|
*
|
Laurent Harvey
|
|
-
|
|
-
|
|
(1)
|
Based on 14,702,556 common shares outstanding.
|
See Item 6.B. Compensation above for information
regarding the share-based, option-based, call-option-based, and warrant-based awards held by our directors and executive officers and for a description of our stock option plan and equity incentive plan.
Item 7.
|
Major Shareholders and Related Party Transactions
|
As of June 26, 2017, Neptune owns
5,064,694 common shares representing 34% of our common shares issued and outstanding. The common shares are voting, participating, and have no par value. Neptune also owns a warrant entitling it to acquire 592,500 common shares (in order to obtain 1
common share, 10 warrants must be exercised). Neptune does not have different voting rights than other holders of common shares. To the best of our knowledge, there are no other beneficial owners of 5% or more of any class of our voting securities
other than Mr. George W. Haywood, who, according to a beneficial ownership report on Schedule 13G filed by Mr. Haywood with the Commission, owns 1,479,000 of our common shares, representing 9.9% of our issued and outstanding common
shares.
All common shares, including those held by Neptune, are common shares with the same voting rights. Based on the
records of our registrar and transfer agent, Computershare Trust Company of Canada, as of March 31, 2017, there were approximately 10 registered holders (including The Depository Trust Company) of our common shares resident in the United States
(approximately 10% of all registered holders).
B.
|
Related Party Transactions
|
Please see the section entitled
Related Party Transactions in Item 5. Operating and Financial Review and Prospects.
C.
|
Interests of Experts and Counsel
|
Not applicable.
Item 8.
|
Financial Statements
|
A.
|
Consolidated Statements and Other Financial Information
|
Financial Statements
See Item 17. Financial Statements for our audited consolidated financial statements.
79
Legal Proceedings
Due to the fact that a significant portion of our intellectual property rights are licensed to us by Neptune, we rely on
Neptune to protect a significant portion of the intellectual property rights that we use under our license agreement with Neptune. Neptune is engaged in a number of legal actions related to its intellectual property.
Our former CEO is claiming the payment of approximately $8.5 million and the issuance of equity instruments from the
Neptune group. As our management believes that these claims are not valid, no provision has been recognized. Neptune and its subsidiaries also filed an additional claim to recover certain amounts from the former officer.
We are also involved in other matters arising in the ordinary course of our business. Since management believes that all
related claims are not valid and it is presently not possible to determine the outcome of these matters, no provisions have been made in our financial statements for their ultimate resolution beyond the amounts incurred and recorded for such
matters. The resolution of these other matters could have an effect on our financial statements in the year that a determination is made, however, in managements opinion, the final resolution of all such matters is not projected to have a
material adverse effect on our financial position.
Dividend Policy
We do not anticipate paying any cash dividend on the common shares in the foreseeable future. We presently intend to retain
future earnings to finance the expansion and growth of our business. Any future determination to pay dividends will be at the discretion of our board of directors and will depend on our financial condition, results of operations, capital
requirements and other factors the board of directors deems relevant. In addition, the terms of any future debt or credit facility may preclude us from paying dividends.
Item 9.
|
The Offer and Listing
|
Since March 31, 2011, our common shares
have been listed on the
TSX-V
under the ticker symbol APO. Since January 7, 2013, our common shares have been listed on the NASDAQ Stock Market under the ticker symbol ACST. The following tables set
forth, for the periods indicated, the high and low market prices of our common shares as reported on the
TSX-V
and the NASDAQ Stock Market.
(a) For the five most recent full fiscal years:
|
|
|
|
|
|
|
|
|
|
|
TSX-V
|
|
NASDAQ Stock Market
|
Fiscal year ended
|
|
High $
|
|
Low $
|
|
High US$
|
|
Low US$
|
|
|
|
|
|
Feb. 28, 2013
(1)
|
|
27.60
|
|
16.00
|
|
39.90
|
|
20.00
|
|
|
|
|
|
Feb. 28, 2014
(1)
|
|
43.20
|
|
11.50
|
|
42.00
|
|
10.90
|
|
|
|
|
|
Feb. 28, 2015
(1)
|
|
14.90
|
|
11.50
|
|
13.40
|
|
10.90
|
|
|
|
|
|
Feb. 29, 2016
|
|
7.60
|
|
1.83
|
|
6.10
|
|
1.30
|
|
|
|
|
|
Mar. 31, 2017
|
|
4.03
|
|
1.47
|
|
3.09
|
|
1.11
|
|
(1)
|
Our common shares were consolidated on October 15, 2015, on the basis of one (1) post-consolidation
common share for every 10
pre-consolidation
common shares, and each fractional common share resulting from the consolidation was rounded up. The common share price was increased proportionally to reflect the
consolidation.
|
|
80
(b) For each full financial
quarter of the two most recent full fiscal years and any subsequent period:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TSX-V
|
|
|
NASDAQ Stock Market
|
|
Period
|
|
High $
|
|
|
Low $
|
|
|
High US$
|
|
|
Low US$
|
|
1
st
Quarter ended May 31, 2015
(1)
|
|
|
7.60
|
|
|
|
4.00
|
|
|
|
6.10
|
|
|
|
5.00
|
|
2
nd
Quarter ended Aug. 31, 2015
(1)
|
|
|
5.50
|
|
|
|
3.50
|
|
|
|
4.20
|
|
|
|
3.90
|
|
3
rd
Quarter ended Nov. 30, 2015
(1)
|
|
|
4.70
|
|
|
|
2.65
|
|
|
|
3.80
|
|
|
|
2.01
|
|
4
th
Quarter ended Feb. 29, 2016
|
|
|
4.40
|
|
|
|
1.83
|
|
|
|
3.20
|
|
|
|
1.30
|
|
1
st
Quarter ended May 31, 2016
|
|
|
2.45
|
|
|
|
1.50
|
|
|
|
1.88
|
|
|
|
1.20
|
|
2
nd
Quarter ended Aug. 31, 2016
|
|
|
2.25
|
|
|
|
1.66
|
|
|
|
1.79
|
|
|
|
1.21
|
|
3
rd
Quarter ended Nov. 30, 2016
|
|
|
4.03
|
|
|
|
1.62
|
|
|
|
3.09
|
|
|
|
1.20
|
|
Four-month period ended Mar. 31, 2017
|
|
|
2.66
|
|
|
|
1.47
|
|
|
|
2.03
|
|
|
|
1.11
|
|
|
(1)
|
Our common shares were consolidated on October 15, 2015, on the basis of one (1) post-consolidation
common share for every 10
pre-consolidation
common shares, and each fractional common share resulting from the consolidation was rounded up. The common share price was increased proportionally to reflect the
consolidation.
|
|
(c) For the most recent six months:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TSX-V
|
|
|
NASDAQ Stock Market
|
|
Period
|
|
High $
|
|
|
Low $
|
|
|
High US$
|
|
|
Low US$
|
|
November 2016
|
|
|
3.32
|
|
|
|
1.62
|
|
|
|
2.46
|
|
|
|
1.20
|
|
|
|
|
|
|
December 2016
|
|
|
2.66
|
|
|
|
1.47
|
|
|
|
2.03
|
|
|
|
1.11
|
|
|
|
|
|
|
January 2017
|
|
|
2.32
|
|
|
|
1.64
|
|
|
|
1.75
|
|
|
|
1.20
|
|
|
|
|
|
|
February 2017
|
|
|
1.88
|
|
|
|
1.53
|
|
|
|
1.48
|
|
|
|
1.16
|
|
|
|
|
|
|
March 2017
|
|
|
2.12
|
|
|
|
1.53
|
|
|
|
1.65
|
|
|
|
1.14
|
|
|
|
|
|
|
April 2017
|
|
|
1.88
|
|
|
|
1.70
|
|
|
|
1.44
|
|
|
|
1.24
|
|
|
|
|
|
|
May 2017
|
|
|
1.83
|
|
|
|
1.65
|
|
|
|
1.35
|
|
|
|
1.23
|
|
The holders of common shares are entitled to vote at all meetings of our shareholders except
meetings at which only holders of a specified class or series of shares are entitled to vote. The holders of common shares are entitled to receive dividends as and when declared by the board, if any.
No common shares have been issued subject to call or assessment. There are no
pre-emptive
or conversion rights and no provisions for redemption or purchase for cancellation, surrender, or sinking or purchase funds. Our common shares must be issued as fully-paid and
non-assessable,
and are not subject to further capital calls by us. All of the common shares rank equally as to voting rights, participation in a distribution of our assets on a liquidation, dissolution or
winding-up,
and the entitlement to dividends. Common shares are transferable at the offices of our transfer agent and registrar, Computershare Trust Company of Canada, in Toronto, Ontario, Canada and Montreal,
Québec, Canada. There are no restrictions in our corporate documents on the free transferability of the common shares.
Not applicable.
Since March 31, 2011, the common shares have been
listed on the
TSX-V
under the ticker symbol APO. Since January 7, 2013, the common shares have been listed on the NASDAQ Stock Market under the ticker symbol ACST.
Not applicable.
Not applicable.
81
F.
|
Expenses of the Issuer
|
Not applicable.
Item 10.
|
Additional Information
|
Not applicable.
B.
|
Memorandum and Articles of Association
|
We were incorporated on
February 1, 2002 under Part 1A of the
Companies Act
(Québec) under the name
9113-0310 Québec
Inc. On August 7, 2008, pursuant to a Certificate of Amendment,
we changed our name to Acasti Pharma Inc., our share capital, the provisions regarding the restrictions on securities transfers and our borrowing powers. On November 7, 2008, pursuant to a Certificate of Amendment, we
further revised our provisions regarding our borrowing powers. We became a reporting issuer in Québec on November 17, 2008. On February 14, 2011, the
Business Corporations Act
(Québec) came into effect and replaced the
Companies Act
(Québec). We are now governed by the
Business Corporations Act
(Québec), or the BCA.
Register, Entry Number
and Purposes
Our articles of incorporation, as amended, or Articles, and general
by-laws,
do not define any of our objects and purposes. In that respect, we have no limit on the type of business we can carry out.
Directors Powers
Our Articles and
by-laws
do not contain any provision regarding: (a) a
directors power in the absence of an independent quorum, to vote compensation to itself or any members of the committees of the board; (b) retirement or
non-retirement
of directors under an age
limit requirement; and (c) number of shares, if any, required for a directors qualification.
Our
by-laws
provide that a director may not vote on a resolution to approve, amend or terminate a contract or transaction in which the director has any financial stake that may reasonably be considered to influence
decision-making or be present during deliberations concerning the approval, amendment or termination of such a contract or transaction, unless the contract or transaction: (a) relates primarily to the remuneration of the director or an
associate of the director as a director of us or an affiliate of us, (b) relates primarily to the remuneration of the director or an associate of the director as an officer, employee or mandatary of us or an affiliate of us, if we are not a
reporting issuer, (c) is for indemnity or liability insurance, or (d) is with an affiliate of us, and the sole interest of the director is as a director or officer of the affiliate. In addition, our
by-laws
provide that a director must avoid placing himself or herself in any situation where his or her personal interests would be in conflict with his obligations as a director of ours, and that a director
must disclose to us any interest he or she has in a business or association that may place him or her in a situation of conflict of interest and of any right he or she may set up against us, indicating their nature and value, where applicable.
Our Articles provide that the board may, on behalf us, (a) borrow money, (b) issue, reissue, sell or pledge debt
instruments, (c) guarantee the obligations of a third party, and (d) hypothecate all or any of its assets, both present and future, to guarantee the performance of any of our obligations.
The quorum at every meeting of the board has been set to the minimum number of directors required under our Articles. In the
absence of a quorum, a director has no power to make any decision regarding, among other things, compensation to himself or herself or to any member of the committees of the board.
Our
by-laws
do not contain any requirements with respect to a mandatory retirement age
for our directors and the number of shares required for directors qualifications.
82
Rights, Preferences and Restrictions Attaching to Each Class of Shares
Our authorized capital consists of an unlimited number of no par value common shares and an unlimited number of no par value
Class B, Class C, Class D and Class E preferred shares (collectively, the preferred shares), issuable in one or more series. As of March 31, 2017, there were:
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|
|
a total of 14,702,556 common shares issued and outstanding and no preferred shares issued and outstanding;
|
|
|
|
990,726 options to purchase common shares issued and outstanding, at a weighted average exercise price of
$3.49 per common share;
|
|
|
|
18,400,000 Series 8 public offering warrants issued in 2014 to purchase common shares issued and outstanding
(including 592,500 warrants held by Neptune), at an exercise price of US$1.50 per common share (10 warrants must be exercised in order to acquire one common share);
|
|
|
|
161,654 Series 9 private placement warrants issued in 2014 to purchase common shares issued and outstanding,
at an exercise price of $13.30 per common share;
|
|
|
|
$2,000,000 aggregate principal amount of unsecured convertible debentures, maturing on February 21, 2020,
issued in our February 2017 private placement and contingent warrants to acquire up to 1,052,630 common shares:
|
|
○
|
the debentures are convertible into common shares at any time by the holder at a fixed price of $1.90 per
common share, except if we pay before the maturity all or any portion of the convertible debentures;
|
|
○
|
if we pay all or any portion of the convertible debentures before maturity, then warrants become exercisable
at $1.90 per common share for the equivalent convertible debenture amount prepaid.
|
|
○
|
the contingent warrants will be exercisable for the remaining term of the convertible debentures for the same
price as the conversion options;
|
|
|
|
warrants issued in connection with our February 2017 public offering to purchase up to 1,965,259 common shares
at an exercise price of $2.15 per common share, at any time until February 21, 2022; and
|
|
|
|
broker warrants issued in connection with our February 2017 public offering to purchase up to 234,992 common
shares at an exercise price of $2.15 per common share, at any time until February 21, 2018.
|
The
following is a brief description of the rights, privileges, conditions and restrictions attaching to the common shares and preferred shares.
Common
Shares
Voting Rights
Each common share entitles its holder to receive notice of, and to attend and vote at, all annual or special meetings of our
shareholders. Each common share entitles its holder to one vote at any meeting of our shareholders, other than meetings at which only the holders of a particular class or series of shares are entitled to vote due to statutory provisions or the
specific attributes of this class or series.
Dividends
Subject to the prior rights of the holders of preferred shares ranking before the common shares as to dividends, the holders of
common shares are entitled to receive dividends as declared by the board our funds that are available for the payment of dividends.
Winding-up
and Dissolution
In the event of our voluntary or involuntary
winding-up
or dissolution, or any other distribution of our assets among our shareholders for the purposes of winding up its affairs, the holders of common shares shall be entitled to receive, after payment by us to
the holders of preferred shares ranking prior to common shares regarding the distribution of our assets in the case of
winding-up
or dissolution, share for share, the remainder of our property, with neither
preference nor distinction. The order of priority, applicable to all classes of our shares with respect to the redemption, liquidation, dissolution or distribution of property (the order of priority) is as follows: First, the
83
Class E
non-voting
shares; Second, the Class D
non-voting
shares; Third, the Class B multiple voting
shares and Class C
non-voting
shares,
pari passu
; and Fourth, the common shares. Notwithstanding the order of priority, shareholders of a class of shares may renounce the order of priority by
unanimous approval by all shareholders of that class of shares.
Preferred Shares
Class B Multiple Voting Shares
Each Class B multiple voting share entitles the holder thereof to 10 votes per share in all of our shareholder
meetings.
Dividends.
Holders of Class B multiple voting shares are entitled to receive, as and
when such dividends are declared, an annual
non-cumulative
dividend of 5% on the amount paid for the said shares, payable at the time and in the manner which the directors may determine and subject to the
order of priority.
Participation.
Subject to the provisions of subsection 5.2.2 of our Articles,
holders of Class B multiple voting shares do not have the right to participate in our profits or surplus assets.
Conversion
. Holders of Class B multiple voting shares have the right, at their entire discretion, to convert, part
or all of the Class B multiple voting shares they hold into common shares on the basis of 1 common share for each Class B multiple voting share converted.
Redemption
. Subject to the provisions of the BCA and the order of priority, holders of Class B multiple voting
shares have the right to demand from us, upon 30 days written notice, that we redeem the Class B multiple voting shares at a price equivalent to the amount paid for such shares plus the redemption premium, as defined in subsection
5.2.4.1 of the Articles, and any and all declared but yet unpaid dividends on same.
Liquidation.
In the event of
our dissolution or liquidation or any other distribution of our property, the Class B voting shareholders have the right to be reimbursed for the amount paid for their Class B multiple voting shares plus the redemption premium, as defined
in subsection 5.2.4.1 of our Articles as well as the amount of any and all declared but yet unpaid dividends on their shares, subject to the order of priority.
Class C
Non-Voting
Shares
Subject to the provisions of the BCA, holders of Class C
non-voting
shares are
neither entitled to vote at any meeting of our shareholders, receive a notice of any such meeting, nor attend any such meeting.
Dividends
. Holders of Class C
non-voting
shares are entitled to receive, as
and when such dividends are declared, an annual
non-cumulative
dividend of 5% on the amount paid for the said shares, plus a redemption premium as defined in subsection 5.3.6.1 of our Articles, payable at
the time and in the manner which the directors may determine and subject to the order of priority.
Participation.
Subject to the provisions of subsection 5.3.2 of our Articles, holders of Class C
non-voting
shares do not have the right to participate in our profits or surplus assets.
Conversion.
Holders of Class C
non-voting
shares have the
right, at their entire discretion, to convert, part or all of the Class C
non-voting
shares they hold into common shares on the basis of 1 common share for each Class C
non-voting
share converted.
Forced Conversion
. All of our Class C
non-voting
shares shall automatically be converted in common shares upon the request of an unrelated third-party investor in us investing more than $500,000, or any other amount to be determined by the board of
directors in us and requesting as a condition to the investment that the Class C
non-voting
shares be converted into common shares on the basis of 1 common share for each Class C
non-voting
share converted.
Redemption.
Subject to the provisions
of the BCA and the order of priority, holders of Class C
non-voting
shares have the right to demand, upon 30 days written notice, that we redeem their Class C
non-voting
shares at a price equivalent to the amount paid for the shares plus the redemption premium, as defined in subsection 5.3.6.1 of our Articles, and any and all declared but yet unpaid dividends on the
shares.
Liquidation.
In the event of our dissolution or liquidation or any other distribution of our property,
Class C
non-voting
shareholders have the right to be reimbursed for the amount paid for their Class C
non-voting
shares plus the redemption premium, as defined
in subsection 5.3.6.1 of our Articles, as well as the amount of any and all declared but yet unpaid dividends on their shares, subject to the order of priority.
84
Class D
Non-Voting
Shares
Subject to the provisions of the BCA, holders of Class D
non-voting
shares are
neither entitled to vote at any meeting of the shareholders, receive a notice of any such meeting, nor attend any such meeting.
Dividends.
Holders of Class D
non-voting
shares are entitled
to receive, as and when such dividends are declared, a monthly
non-cumulative
dividend of 0.5% to 2% on the amount paid for the shares, plus a redemption premium as defined in subsection 5.4.6.1 of our
Articles, payable at the time and in the manner which the directors may determine and subject to the order of priority.
Participation.
Subject to the provisions of subsection 5.4.2 of our Articles, holders of
Class D
non-voting
shares do not have the right to participate in our profits or surplus assets.
Conversion.
Holders of Class D
non-voting
shares have the
right, at their discretion, to convert, part or all of their Class D
non-voting
shares into common shares on the basis of a number of common shares equal to the number of Class D
non-voting
shares converted multiplied by a conversion ratio, calculated as follows:
|
|
|
|
|
Conversion Ratio =
|
|
The product obtained by multiplying a factor to be agreed at the time of
the issuance of the Class D
non-voting
shares by the average amount paid per share for the Class D
non-voting
shares plus the redemption premium per share, as
defined in subsection 5.4.6.1 of our Articles as well as the amount of any and all declared but yet paid dividends on the shares
|
|
Fair market value of the common shares at the date of any conversion of Class D
non-voting
shares into common shares
|
Conversion
All of our Class C
non-voting
shares automatically convert into common shares upon the request of an unrelated third party investor in us, investing more than $500,000, or any other amount to be determined by the board of directors, in us and requesting as a condition to the
investment that the Class C
non-voting
shares be converted into common shares in all cases, on the basis of a number of common shares equal to the number of Class D
non-voting
shares converted multiplied by the conversion ratio, calculated as follows:
|
|
|
|
|
Conversion Ratio =
|
|
The product obtained by multiplying a factor to be agreed at the time of
the issuance of the Class D
non-voting
shares by the average amount paid per share for the Class D
non-voting
shares plus the redemption premium per share, as
defined in subsection 5.4.6.1 of our Articles as well as the amount of any and all declared but yet paid dividends on the shares
|
|
Fair market value of the common shares at the date of any conversion of Class D
non-voting
shares into common shares
|
Redemption.
Subject to the provisions of the BCA and the order of
priority, holders of Class D
non-voting
shares have the right to demand, upon 30 days written notice, that we redeem their Class D
non-voting
shares at a
price equivalent to the amount paid for the shares plus the redemption premium, as defined in subsection 5.4.6.1 of our Articles, and any and all declared but yet unpaid dividends on the shares.
Liquidation.
In the event of our dissolution or liquidation or any other distribution of our property, the
Class D
non-voting
shareholders shall have the right to be reimbursed for the amount paid for their Class D
non-voting
shares plus the redemption premium, as
defined in subsection 5.4.6.1 of our Articles as well as the amount of any and all declared but yet unpaid dividends on their shares, subject to the order of priority.
Class E
Non-Voting
Shares
Subject to the provisions of the BCA, holders of Class E
non-voting
shares are
neither entitled to vote at any meeting of the shareholders, receive a notice of any such meeting, nor attend any such meeting.
Dividends.
Holders of Class E
non-voting
shares are entitled
to receive, as and when such dividends are declared, a monthly
non-cumulative
dividend of 0.5% to 2% on the amount paid for the shares, payable at the time and in the manner which the directors may determine
and subject to the order of priority.
Participation.
Subject to the provisions of subsection 5.5.2 of our Articles,
holders of Class E
non-voting
shares do not have the right to participate in our profits.
85
Conversion.
Holders of Class E
non-voting
shares have the right, at their discretion, to convert, part or all of their Class E
non-voting
shares into common shares on the basis of a number of common
shares equal to the number of Class E
non-voting
shares converted multiplied by the conversion ratio, calculated as follows:
|
|
|
|
|
Conversion Ratio =
|
|
The product obtained by multiplying a factor to be agreed at the time of
the issuance of the Class E
non-voting
shares by the average amount paid per share for the Class E
non-voting
shares plus the amount of any and all declared
but yet paid dividends on the shares
|
|
Fair market value of the common shares at the date of any conversion of Class E
non-voting
shares into common shares
|
Redemption.
Subject to the provisions of the BCA and the order of
priority, we have the right, upon 30 days written notice, to redeem the Class E
non-voting
shares at a price equivalent to the amount paid for the shares and any and all declared but yet unpaid
dividends on the shares.
Liquidation.
In the event of our dissolution or liquidation or any other
distribution of our property, the Class E
non-voting
shareholders have the right to be reimbursed for the amount paid for their Class E
non-voting
shares as
well as the amount of any and all declared but yet unpaid dividends on the shares, subject to the order of priority.
Procedures to Change the Rights of
Shareholders
In order to change the rights attached to all classes of our shares, the vote of at least 66 2/3% of the
holders of each class, must be cast at a shareholders meeting called for amending the rights attached to our common shares or preferred shares, as the case may be.
Ordinary and Extraordinary Shareholders Meetings
Our
by-laws
provide that our annual meeting of shareholders must be held on a yearly
basis on such date and on such time as may be fixed by the board. Our
by-laws
provide that special meetings of shareholders may be called at any time as determined by the board. Our shareholders are entitled
to call special meetings of shareholders, provided that they hold at least 10% of the issued and outstanding shares entitled to vote at the meeting so called. Our
by-laws
provide that notice of each annual and
special meeting of shareholders must be sent to the shareholders entitled to attend such meetings not less than 21 days and not more than 60 days before the date fixed for such meeting. Our
by-laws
provide
that during any meeting of shareholders, the attendance, in person or by proxy, of at least two shareholders representing at least 10% of the issued and outstanding shares entitled to vote at the meeting will constitute a quorum.
Limitations on Rights to Own Securities
There exists no limitation on the right to own our securities.
Impediments to Change of Control
Neither our Articles nor
by-laws
contain any provision that would have an effect of
delaying, deferring or preventing a change in control of us.
Stockholder Ownership Disclosure Threshold in Bylaws
Our Articles and
By-laws
do not contain any provision requiring a shareholder to
disclose his ownership above a particular threshold.
For the two years preceding this annual
report, we have not entered into any material contracts, other than contracts entered into in the ordinary course of our business, besides the indenture relating to the warrants that we issued in connection our public offering of units in February
2017.
Subject to the following paragraph, there is
no law or governmental decree or regulation in Canada that restricts the export or import of capital, or affects the remittance of dividends, interest or other payments to
non-resident
holders of our
subordinate voting shares, other than withholding tax requirements.
86
There is no limitation imposed by Canadian law or by our Articles or our other
charter documents on the right of a
non-resident
to hold or vote voting shares, other than as provided by the
Investment Canada Act
(Canada), or Investment Canada Act, the
North American Free Trade
Agreement Implementation Act
(Canada), or North American Free Trade Agreement, and the
World Trade Organization Agreement Implementation Act
. The Investment Canada Act requires notification and, in certain cases, advance review and
approval by the Government of Canada of an investment to establish a new Canadian business by a
non-Canadian
or of the acquisition by a
non-Canadian
of
control of a Canadian business, all as defined in the Investment Canada Act. Generally, the threshold for review will be higher in monetary terms for a member of the World Trade Organization or North American Free Trade
Agreement.
The following is a summary of certain U.S. federal
income tax considerations to a U.S. Holder (as defined below) arising from and relating to the acquisition, ownership, and disposition of our common shares as capital assets.
This summary provides only general information and does not purport to be a complete analysis or listing of all potential U.S.
federal income tax consequences that may apply to a U.S. Holder as a result of the acquisition, ownership, and disposition of our common shares. In addition, this summary does not take into account the individual facts and circumstances of any
particular U.S. Holder that may affect the U.S. federal income tax consequences applicable to that U.S. Holder. Accordingly, this summary is not intended to be, and should not be construed as, legal or U.S. federal income tax advice with respect to
any U.S. Holder. Each U.S. Holder should consult its own tax advisor regarding the U.S. federal, U.S. state and local, and
non-U.S.
tax consequences arising from or relating to the acquisition, ownership, and
disposition of our common shares.
No legal opinion from U.S. legal counsel or ruling from the Internal Revenue Service, or
IRS, has been requested, or will be obtained, regarding the U.S. federal income tax consequences to U.S. Holders of the acquisition, ownership, and disposition of our common shares. This summary is not binding on the IRS, and the IRS is not
precluded from taking a position that is different from, and contrary to, the positions taken in this summary. In addition, because the authorities on which this summary is based are subject to various interpretations, the IRS and the U.S. courts
could disagree with one or more of the positions taken in this summary.
Scope of this Disclosure
Authorities
This
summary is based on the U.S. Internal Revenue Code of 1986, as amended, or the Code, U.S. Treasury Regulations promulgated thereunder (whether final, temporary or proposed), published IRS rulings, judicial decisions, published administrative
positions of the IRS, and the Convention between Canada and the United States of America with Respect to Taxes on Income and on Capital, signed September 26, 1980, as amended (the
Canada-U.S.
Tax Treaty).
Any of the authorities on which this summary is based could be changed in a material and adverse manner at any time, and any such change could be applied on a retroactive basis. Unless otherwise discussed, this summary does not discuss the potential
effects, whether adverse or beneficial, of any proposed legislation.
U.S. Holders
For purposes of this summary, a U.S. Holder is a beneficial owner of common shares that, for U.S. federal income
tax purposes, is (a) an individual who is a citizen or resident of the United States, (b) a corporation, or other entity classified as a corporation for U.S. federal income tax purposes, that is created or organized in or under the laws of
the U.S., any state in the United States or the District of Columbia, (c) an estate if the income of such estate is subject to U.S. federal income tax regardless of the source of such income, or (d) a trust if (i) such trust has
validly elected to be treated as a U.S. person for U.S. federal income tax purposes or (ii) a U.S. court is able to exercise primary supervision over the administration of such trust and one or more U.S. persons have the authority to control
all substantial decisions of such trust.
U.S. Holders Subject to Special U.S. Federal Income Tax Rules Not Addressed
This summary does not address the U.S. federal income tax consequences applicable to U.S. Holders that are subject to special
provisions under the Code, including, but not limited to, the following U.S. Holders: (a) U.S.
87
Holders that are
tax-exempt
organizations, qualified retirement plans, individual retirement accounts, or other tax deferred accounts; (b) U.S.
Holders that are financial institutions, insurance companies, real estate investment trusts, or regulated investment companies; (c) U.S. Holders that are dealers in securities or currencies or U.S. Holders that are traders in securities that
elect to apply a
mark-to-market
accounting method; (d) U.S. Holders that have a functional currency other than the U.S. dollar; (e) U.S. Holders
subject to the alternative minimum tax provisions of the Code; (f) U.S. Holders that own common shares as part of a straddle, hedging transaction, conversion transaction, integrated transaction, constructive sale, or other arrangement involving
more than one position; (g) U.S. Holders that acquired common shares through the exercise of employee stock options or otherwise as compensation for services; (h) U.S. Holders that hold common shares other than as a capital asset within
the meaning of Section 1221 of the Code; (i) U.S. Holders that beneficially own (directly, indirectly or by attribution) 10% or more of our voting securities or otherwise held 10% or more of our total combined voting power; and
(j) U.S. expatriates. U.S. Holders that are subject to special provisions under the Code, including U.S. Holders described above, should consult their own tax advisor regarding the U.S. federal, U.S. federal alternative minimum, U.S. federal
estate and gift, U.S. state and local, and
non-U.S.
tax consequences arising from and relating to the acquisition, ownership, and disposition of the common shares.
If an entity or arrangement that is classified as a partnership for U.S. federal income tax purposes holds common shares, the
U.S. federal income tax consequences to that partnership and the partners of that partnership generally will depend on the activities of the partnership and the status of the partners. Partners of entities that are classified as partnerships for
U.S. federal income tax purposes should consult their own tax advisors regarding the U.S. federal income tax consequences arising from and relating to the acquisition, ownership and disposition of the common shares.
Tax Consequences Other than U.S. Federal Income Tax Consequences Not Addressed
This summary does not address the U.S. estate and gift, alternative minimum, state, local or
non-U.S.
tax consequences to U.S. Holders of the acquisition, ownership, and disposition of our common shares. Each U.S. Holder should consult its own tax advisor regarding the U.S. estate and gift,
alternative minimum, state, local and foreign tax consequences arising from and relating to the acquisition, ownership, and disposition of our common shares.
U.S. Federal Income Tax Considerations of the Acquisition, Ownership, and Disposition of Common Shares
Distributions on Common Shares
Subject to the possible application of the passive foreign investment company, or PFIC, rules described below (see the more
detailed discussion below at Passive Foreign Investment Company Rules), a U.S. Holder that receives a distribution, including a constructive distribution or a taxable stock distribution, with respect to the common shares generally
will be required to include the amount of that distribution in gross income as a dividend (without reduction for any Canadian income tax withheld from such distribution) to the extent of our current or accumulated earnings and profits
(as computed for U.S. federal income tax purposes). To the extent that a distribution exceeds our current and accumulated earnings and profits, the excess amount will be treated (a) first, as a
tax-free
return of capital to the extent of a U.S. Holders adjusted tax basis in the common shares with respect to which the distribution is made (resulting in a corresponding reduction in the tax basis
of those common shares) and, (b) thereafter, as gain from the sale or exchange of those common shares (see the more detailed discussion at Disposition of Common Shares below). We do not intend to calculate our current or
accumulated earnings and profits for U.S. federal income tax purposes and, therefore, will not be able to provide U.S. Holders with that information. U.S. Holders should therefore assume that any distribution by us with respect to our common shares
will constitute a dividend. However, U.S. Holders should consult their own tax advisors regarding whether distributions from us should be treated as dividends for U.S. federal income tax purposes. Dividends paid on our common shares generally will
not be eligible for the dividends received deduction allowed to corporations under the Code with respect to dividends received from U.S. corporations.
A dividend paid by us generally will be taxed at the preferential tax rates applicable to long-term capital gains if, among
other requirements, (a) we are a qualified foreign corporation (as defined below), (b) the U.S. Holder receiving the dividend is an individual, estate, or trust, and (c) the dividend is paid on common shares that have been
held by the U.S. Holder for at least 61 days during the
121-day
period beginning 60 days before the
ex-dividend
date (i.e., the first date that a purchaser
of the common shares will not be entitled to receive the dividend).
88
For purposes of the rules described in the preceding paragraph, we generally will
be a qualified foreign corporation, or a QFC, if (a) we are eligible for the benefits of the
Canada-U.S.
Tax Treaty, or (b) our common shares are readily tradable on an established
securities market in the United States, within the meaning provided in the Code. However, even we satisfy one or more of the requirements, we will not be treated as a QFC if we are classified as a PFIC (as discussed below) for the taxable year
during which we pay the applicable dividend or for the preceding taxable year. The dividend rules are complex, and each U.S. Holder should consult its own tax advisor regarding the application of those rules to them in their particular
circumstances. Even if we satisfy one or more of the requirements, as noted below, there can be no assurance that we will not become a PFIC in the future. Thus, there can be no assurance that we will qualify as a QFC.
Disposition of Common Shares
Subject to the possible application of the PFIC rules described below (see more detailed discussion below at
Passive Foreign Investment Company Rules), a U.S. Holder will recognize gain or loss on the sale or other taxable disposition of common shares (that is treated as a sale or exchange for U.S. federal income tax purposes) equal to
the difference, if any, between (a) the U.S. dollar value of the amount realized on the date of the sale or disposition and (b) the U.S. Holders adjusted tax basis (determined in U.S. dollars) in the common shares sold or otherwise
disposed of. Any such gain or loss generally will be capital gain or loss, which will be long-term capital gain or loss if the common shares are held for more than one year. Each U.S. Holder should consult its own tax advisor as to the tax treatment
of dispositions of common shares in exchange for Canadian dollars.
Preferential tax rates apply to long-term capital gains
of a U.S. Holder that is an individual, estate, or trust. There are currently no preferential tax rates for long-term capital gains of a U.S. Holder that is a corporation. Deductions for capital losses are subject to complex limitations.
Passive Foreign Investment Company Rules
Special, generally unfavorable, rules apply to the ownership and disposition of the stock of a PFIC. For U.S. federal income
tax purposes, a
non-U.S.
corporation is classified as a PFIC for each taxable year in which either:
|
|
|
at least 75% of its gross income is passive income (referred to as the income test);
or
|
|
|
|
at least 50% of the average value of its assets is attributable to assets that produce passive income or are
held for the production of passive income (referred to as the asset test).
|
Passive income includes the
following types of income:
|
|
|
dividends, royalties, rents, annuities, interest, and income equivalent to interest; and
|
|
|
|
net gains from the sale or exchange of property that gives rise to dividends, interest, royalties, rents, or
annuities and certain gains from the commodities transactions.
|
In determining whether we are a PFIC, we
will be required to take into account a pro rata portion of the income and assets of each corporation in which we own, directly or indirectly, at least 25% by value.
We have not made a determination as to whether we were a PFIC for the 2017 taxable year(s) or whether we will be a PFIC for the
current taxable year. Accordingly, there can be no assurance that we were not a PFIC for the 2017 taxable year(s). Whether we are a PFIC depends on complex U.S. federal income tax rules that are subject to differing interpretations and whose
application to us is uncertain. Further, since our PFIC status will depend upon the composition of our income and assets and the fair market value of our assets from time to time (including whether we own, directly or indirectly, at least 25% by
value, of the stock of any subsidiary) and generally cannot be determined until the end of a taxable year, there can be no assurance that we will not be a PFIC for the current taxable year. In addition, we cannot predict whether the composition of
our income and assets (including income and assets held indirectly) or the fair market value of its assets from time to time may result in it being treated as a PFIC in any future taxable year. Accordingly, no assurance can be given that we are not
a PFIC or will not become a PFIC in subsequent taxable years.
Generally, if we are or have been treated as a PFIC for any
taxable year during a U.S. Holders holding period of common shares, any excess distribution with respect to the common shares would be allocated rateably over the U.S. Holders holding period. The amounts allocated to the
taxable year of the excess distribution and to
89
any year before we became a PFIC would be taxed as ordinary income. The amount allocated to each other taxable year would be subject to tax at the highest rate in effect for individuals or
corporations in that taxable year, as appropriate, and an interest charge would be imposed on the amount allocated to that taxable year. Distributions made in respect of common shares during a taxable year will be excess distributions to the extent
they exceed 125% of the average of the annual distributions on common shares received by the U.S. Holder during the preceding three taxable years or the U.S. Holders holding period, whichever is shorter.
Generally, if we are treated as a PFIC for any taxable year during which a U.S. Holder owns common shares, any gain on the
disposition of the common shares would be treated as an excess distribution and would be allocated rateably over the U.S. Holders holding period and subject to taxation in the same manner as described in the preceding paragraph.
Certain elections may be available (including a
mark-to-market
or qualified electing fund election) to U.S. Holders in limited circumstances that may mitigate the adverse consequences resulting
from PFIC status, particularly if they are made in the first taxable year during such holders holding period in which we are treated as a PFIC. U.S. Holders should be aware that, for each tax year, if any, that we are a PFIC, we can provide no
assurances that we will make available to U.S. Holders the information U.S. Holders require to make a qualified electing fund election with respect to us.
If we were were to be treated as a PFIC in any taxable year, a U.S. Holder will generally be required to file an annual report
with the IRS containing such information as the U.S. Treasury Department may require.
Each current or prospective U.S.
Holder should consult its own tax advisor regarding our status as a PFIC, the possible effect of the PFIC rules to such holder and information reporting required if we were a PFIC, as well as the availability of any election that may be available to
the holder to mitigate adverse U.S. federal income tax consequences of holding shares in a PFIC.
Receipt of Foreign Currency
The amount of a distribution paid in Canadian dollars or Canadian dollar proceeds received on the sale or other taxable
disposition of common shares will generally be equal to the U.S. dollar value of the currency on the date of receipt. If any Canadian dollars received with respect to the common shares are later converted into U.S. dollars, U.S. Holders may realize
gain or loss on the conversion. Any gain or loss generally will be treated as ordinary income or loss and generally will be from sources within the United States for U.S. foreign tax credit purposes. Each U.S. Holder should consult its own tax
advisor concerning the possibility of foreign currency gain or loss if any such currency is not converted into U.S. dollars on the date of receipt.
Foreign Tax Credit
Subject to certain limitations, a U.S. Holder who pays (whether directly or through withholding) Canadian or other foreign
income tax with respect to the common shares may be entitled, at the election of the U.S. Holder, to receive either a deduction or a credit for Canadian or other foreign income tax paid. Dividends paid on common shares generally will constitute
income from sources outside the United States. The foreign tax credit rules (including the limitations with respect thereto) are complex, and each U.S. Holder should consult its own tax advisor regarding the foreign tax credit rules, having regard
to such holders particular circumstances.
Information Reporting; Backup Withholding
Generally, information reporting and backup withholding will apply to distributions on, and the payment of proceeds from the
sale or other taxable disposition of, the common shares unless (i) the U.S. Holder is a corporation or other exempt entity, or (ii) in the case of backup withholding, the U.S. Holder provides a correct taxpayer identification number and
certifies that the U.S. Holder is not subject to backup withholding.
Backup withholding is not an additional tax. Any
amount withheld generally will be creditable against a U.S. Holders U.S. federal income tax liability or refundable to the extent that it exceeds such liability provided the required information is provided to the IRS in a timely manner.
In addition, certain categories of U.S. Holders must file information returns with respect to their investment in a
non-U.S.
corporation. For example, certain U.S. Holders must file IRS Form 8938 with respect to certain specified foreign financial assets (such as the common shares) with an aggregate value in excess of
US$50,000 (and, in some circumstances, a higher threshold). Failure to do so could result in substantial penalties and in the extension of the statute of limitations with respect to such holders U.S. federal income tax returns. Each U.S.
Holder should consult its own tax advisor regarding application of the information reporting and backup withholding rules to it in connection with an investment in our common shares.
90
Medicare Contribution Tax
U.S. Holders that are individuals, estates or certain trusts generally will be subject to a 3.8% Medicare contribution tax on,
among other things, dividends on, and capital gains from the sale or other taxable disposition of, common shares, subject to certain limitations and exceptions. Each U.S. Holder should consult its own tax advisor regarding possible application of
this additional tax to income earned in connection with an investment in our common shares.
F.
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Dividends and Paying Agents
|
Not applicable.
Not applicable.
Any statement in this annual report about
any of our contracts or other documents is not necessarily complete. If the contract or document is filed as an exhibit to this annual report, the contract or document is deemed to modify the description contained in this annual report. You must
review the exhibits themselves for a complete description of the contract or document.
Our SEC filings are available at
the SECs website at www.sec.gov. You may also read and copy any document we file with the SEC at the public reference facilities maintained by the SEC at SEC Headquarters, Public Reference Section, 100 F Street, N.E., Washington D.C. 20549.
You may obtain information on the operation of the SECs public reference facilities by calling the SEC at
1-800-SEC-0330.
In addition, we are required by Canadian securities laws to file documents electronically with Canadian securities regulatory authorities and these filings are available on our SEDAR profile at www.sedar.com. Requests for such documents should be
directed to our Corporate Secretary.
I.
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Subsidiary Information
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Not applicable.
Item 11.
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Quantitative and Qualitative Disclosure about Market Risk
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Information
relating to quantitative and qualitative disclosures about market risks is detailed in Item 5. Operating and Financial Review and Prospects, as well as in Note 19 to our audited consolidated financial statements contained in Item
17. Financial Statements.
Item 12.
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Description of Securities other than Equity Securities
|
Not applicable.
Not applicable.
Not applicable.
D.
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American Depositary Shares
|
Not applicable.
91
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
Acasti Pharma Inc. (
Acasti
or the
Corporation
) is incorporated under the
Business Corporations Act
(Québec) (formerly Part 1A of the
Companies Act
(Québec)). The Corporation is domiciled in Canada and its registered office is located at 545,
Promenade du Centropolis, Laval, Québec, H7T 0A3. Neptune Technologies and Bioressources Inc. (
Neptune
or the
parent
) currently owns approximately 34% of the issued and outstanding Class A shares (
Common Shares
)
of the Corporation. The Corporation, Neptune and Biodroga Nutraceuticals Inc., a subsidiary of Neptune, are collectively referred to as the Group.
Pursuant to a license agreement entered into with Neptune in August 2008, as amended, Acasti has been granted an exclusive
worldwide license to use Neptunes intellectual property to develop, clinically study and market new pharmaceutical products to treat human cardiovascular conditions. Neptunes intellectual property is related to the extraction of
ingredients from marine biomasses, such as krill. The eventual products are aimed at applications in the prescription drug, over-the-counter medicine and medical foods markets. In December 2012, the Corporation entered into a prepayment agreement
with Neptune pursuant to which the Corporation exercised its option under the License Agreement to pay in advance all of the future royalties payable under the license which was exercised in fiscal 2014. As a result of the royalty prepayment, Acasti
is no longer required to pay any royalties to Neptune under the License Agreement during its term for the use of the intellectual property under license. The license allows Acasti to exploit the intellectual property rights in order to develop novel
active pharmaceutical ingredients (APIs) into commercial products for the prescription drugs and the medical food markets.
The Corporation is subject to a number of risks associated with the conduct of its clinical program and its results, the
establishment of strategic alliances and the successful development of new pharmaceutical products and their marketing. The Corporation has incurred significant operating losses and negative cash flows from operations since inception. To date, the
Corporation has financed its operations through the public offering and private placement of Common Shares and convertible debt, the proceeds from research grants and research tax credits, and the exercises of warrants, rights and options. To
achieve the objectives of its business plan, Acasti plans to raise the necessary funds through additional securities offerings and the establishment of strategic alliances as well as additional research grants and research tax credits. The
Corporation anticipates that the products developed by the Corporation will require approval from the U.S Food and Drug Administration and equivalent regulatory organizations in other countries before their sale can be authorized. The ability of the
Corporation to ultimately achieve profitable operations is dependent on a number of factors outside of the Corporations control.
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(a)
|
Statement of compliance:
|
These financial statements have been prepared in
accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). Beginning in fiscal 2017, the Corporations fiscal year end is on March 31. Fiscal
2017 is a transition year, and includes thirteen months of operations, beginning on March 1, 2016 and ending on March 31, 2017. As a result, the above financial statements and corresponding notes to financial statements include two
unaudited periods: the one-month period ended March 31, 2017 and the twelve-month period ended February 28, 2017. The Canadian Securities regulator permits, in the transition year, the presentation of a thirteen-month period for the
financial year ended March 31, 2017.
The financial statements were approved by the Board of Directors on June 6, 2017.
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(b)
|
Basis of measurement:
|
The financial statements have been prepared on the historical cost basis,
except for:
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Stock-based compensation which is measured pursuant to IFRS 2,
Share-based payments
(
Note 3(e) (ii
)); and,
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Derivative warrant liabilities measured at fair value on a recurring basis
(Note 10)
.
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F-9
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian dollars, except where noted and for share and per share amounts)
2.
|
Basis of preparation (continued):
|
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(c)
|
Going concern uncertainty:
|
The Corporation has incurred operating losses and
negative cash flows from operations since inception. The Corporations current assets of $10.2 million as at March 31, 2017 include cash and cash equivalents totalling $9.8 million, mainly generated by the net proceeds from the Public
Offering and Private Placement completed on February 21, 2017 as well as the public offering completed on December 3, 2013 and private offering completed on February 7, 2014 (the
Previous Offerings
). The Corporations
liabilities total $3.8 million at March 31, 2017 and are comprised primarily of $2.1 million in amounts due to or accrued for creditors, $1.4 million for unsecured convertible debentures and $0.2 million for derivative warrant liabilities. The
Corporations current assets as at this date are projected to be significantly less than needed to support the current liabilities as at that date when combined with the projected level of expenses for the next twelve months, including not only
the preparation for, but the planned initiation of the Phase 3 clinical study program for its drug candidate, CaPre. Additional funds will also be needed for the expected expenses for the total CaPre Phase 3 research and development phase beyond the
next twelve months. In addition to having raised additional funds during the thirteen-month period ended March 31, 2017, the Corporation is working towards development of strategic partner relationships and plans to raise additional funds
in the future, but there can be no assurance as to when or whether Acasti will complete any financing or strategic collaborations. In particular, raising financing is subject to market conditions and is not within the Corporations control.
Additionally, although the Corporation intends to continue to rely on the support of Neptune for a portion of its general and administrative needs, the continuance of this support is outside of the Corporations control. If the Corporation does
not raise additional funds, find one or more strategic partners or does not receive the continued support from its parent, it may not be able to realize its assets and discharge its liabilities in the normal course of business. As a result, there
exists a material uncertainty that casts substantial doubt about the Corporations ability to continue as a going concern and, therefore, realize its assets and discharge its liabilities in the normal course of business. The Corporation
currently has no other arranged sources of financing.
The financial statements have been prepared on a going concern basis,
which assumes the Corporation will continue its operations in the foreseeable future and will be able to realize its assets and discharge its liabilities and commitments in the ordinary course of business. These financial statements do not include
any adjustments to the carrying values and classification of assets and liabilities and reported expenses that may be necessary if the going concern basis was not appropriate for these financial statements. If the Corporation was unable to continue
as a going concern, material write-downs to the carrying values of the Corporations assets, including the intangible asset, could be required.
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(d)
|
Functional and presentation currency:
|
These financial statements are presented in Canadian
dollars, which is the Corporations functional currency.
|
(e)
|
Use of estimates and judgments:
|
The preparation of the financial statements in
conformity with IFRS requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these
estimates.
Estimates are based on managements best knowledge of current events and actions that the Corporation may
undertake in the future. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.
Critical judgments in applying accounting policies that have the most significant effect on the amounts recognized in the
financial statements include the following:
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Identification of triggering events indicating that the intangible assets might be impaired.
|
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The use of the going concern basis of preparation of the financial statements. At the end of each reporting
period, management assesses the basis of preparation of the financial statements (Note 2(c)).
|
F-10
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
2.
|
Basis of preparation (continued):
|
|
(e)
|
Use of estimates and judgments (continued):
|
Assumptions and estimation uncertainties that have a significant risk of
resulting in a material adjustment within the next financial year include the following:
|
●
|
|
Determination of the recoverable amount of the Corporations cash generating unit (CGU).
|
|
●
|
|
Measurement of derivative warrant liabilities (
note 10
) and stock-based compensation (
note 15
).
|
Also, management uses judgment to determine which research and development (R&D) expenses
qualify for R&D tax credits and in what amounts. The Corporation recognizes the tax credits once it has reasonable assurance that they will be realized. Recorded tax credits are subject to review and approval by tax authorities and therefore,
could be different from the amounts recorded.
3.
|
Significant accounting policies:
|
The accounting policies set out below
have been applied consistently to all periods presented in these financial statements.
|
(a)
|
Financial instruments:
|
A financial instrument is any contract that gives rise to a financial asset of one party and a financial liability or equity
instrument of another party.
|
(i)
|
Non-derivative financial assets:
|
The Corporation has the following non-derivative financial assets: cash, cash equivalents, short-term investments and
receivables. The Corporation determines the classification of its financial assets at initial recognition. The subsequent measurement of financial assets depends on their classification.
Financial assets and liabilities are offset and the net amount presented in the statements of financial position when, and only
when, the Corporation has a legal right to offset the amounts and intends either to settle on a net basis or to realize the asset and settle the liability simultaneously.
Loans and receivables
The classification loans and receivables comprises financial assets with fixed or determinable payments that are
not quoted in an active market. Such assets are recognized initially at fair value plus any directly attributable transaction costs. Subsequent to initial recognition, loans and receivables are measured at amortized cost using the effective interest
method, less any impairment losses.
Cash, cash equivalents, short-term investments and receivables with maturities of less
than one year are classified as loans and receivables.
Cash and cash equivalents comprise cash balances and highly liquid
investments purchased three months or less from maturity.
|
(ii)
|
Non-derivative financial liabilities:
|
The Corporation has the following non-derivative financial liabilities: trade and other payables, payable to parent corporation
and unsecured convertible debentures. Such financial liabilities are recognized initially at fair value plus any directly attributable transaction costs. Subsequent to initial recognition, these financial liabilities are measured at amortized cost
using the effective interest method.
The Corporation derecognizes a financial liability when its contractual obligations
are discharged, cancelled or expire.
F-11
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
3.
|
Significant accounting policies (continued):
|
|
(a)
|
Financial instruments (continued):
|
|
(iii)
|
Compound financial instruments:
|
Compound financial instruments are instruments that can be converted to share capital at the option of the holder, and the
number of shares to be issued is fixed.
The unsecured convertible debentures are compound instruments and have been
separated into liability and equity components. The liability component is recognized initially at the fair value of a similar liability that does not have an equity conversion option. The equity component is recognized initially as the difference
between the fair value of the compound financial instrument as a whole and the fair value of the liability component. Any directly attributable transaction costs are allocated to the liability and equity components in proportion to their initial
carrying amounts. Subsequent to initial recognition, the liability component of a compound financial instrument is measured at amortized cost using the effective interest method. The equity component of a compound financial instrument is not
remeasured subsequent to initial recognition.
Common Shares
Class A Common Shares are classified as equity. Incremental costs directly attributable to the issue of Common Shares and
share options are recognized as a deduction from share capital, net of any tax effects.
|
(v)
|
Derivative financial instruments:
|
The Corporation has issued liability-classified derivatives over its own equity. Derivatives are recognized initially at fair
value; attributable transaction costs are recognized in profit and loss as incurred. Subsequent to initial recognition, derivatives are measured at fair value, and all changes in their fair value are recognized immediately in profit or loss.
|
(vi)
|
Other equity instruments:
|
Warrants, options and rights over the Corporations equity issued outside of share-based payment transactions that do not
meet the definition of a liability instrument are recognized in equity.
|
(i)
|
Recognition and measurement:
|
Equipment is measured at cost less accumulated depreciation and accumulated impairment losses, if any.
Cost includes expenditures that are directly attributable to the acquisition of the asset, including all costs incurred in
bringing the asset to its present location and condition.
Purchased software that is integral to the functionality of the
related equipment is capitalized as part of that equipment.
Gains and losses on disposal of equipment are determined by
comparing the proceeds from disposal with the carrying amount of equipment, and are recognized net within other income or expenses in profit or loss.
The cost of replacing a part of an equipment is recognized in the carrying amount of the item if it is probable that the future
economic benefits embodied within the part will flow to the Corporation, and its cost can be measured reliably. The carrying amount of the replaced part is derecognized. The costs of the day-to-day servicing of equipment are recognized in profit or
loss as incurred.
F-12
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
3.
|
Significant accounting policies (continued):
|
|
(b)
|
Equipment (continued):
|
Depreciation is recognized in profit or loss on either a
straight-line basis or a declining basis over the estimated useful lives of each part of an item of equipment, since this most closely reflects the expected pattern of consumption of the future economic benefits embodied in the asset. Items of
equipment are depreciated from the date that they are available for use or, in respect of assets not yet in service, from the date they are ready for their intended use.
The estimated useful lives and rates for the current and comparative periods are as follows:
|
|
|
|
|
Assets
|
|
Method
|
|
Period/Rate
|
|
|
|
Furniture and office equipment
|
|
Declining balance
|
|
20% to 30%
|
Computer equipment
|
|
Declining balance
|
|
30%
|
Laboratory equipment
|
|
Declining balance
|
|
30%
|
Production equipment
|
|
Straight-line
|
|
10 years
|
Depreciation methods, useful lives and residual values are reviewed at each financial
year-end and adjusted prospectively if appropriate.
|
(i)
|
Research and development:
|
Expenditure on research activities, undertaken with the prospect of gaining new scientific or technical knowledge and
understanding, is recognized in profit or loss as incurred.
Development activities involve a plan or design for the
production of new or substantially improved products and processes. Development expenditure is capitalized only if development costs can be measured reliably, the product or process is technically and commercially feasible, future economic benefits
are probable, and the Corporation intends to and has sufficient resources to complete development and to use or sell the asset. The expenditure capitalized includes the cost of materials, direct labour, overhead costs that are directly attributable
to preparing the asset for its intended use, and borrowing costs on qualifying assets. Other development expenditures are recognized in profit or loss as incurred.
Capitalized development expenditure is measured at cost less accumulated amortization and accumulated impairment losses. As of
the reporting periods presented, the Corporation has not capitalized any development expenditure.
|
(ii)
|
Other intangible assets:
|
Patent costs
Patents for technologies that are no longer in the research phase are recorded at cost. Patent costs include legal fees to
obtain patents and patent application fees. When the technology is still in the research and development phase, those costs are expensed as incurred.
Licenses
Licenses that are acquired by the Corporation and have finite useful lives are measured at cost less accumulated amortization
and accumulated impairment losses.
F-13
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
3.
|
Significant accounting policies (continued):
|
|
(c)
|
Intangible assets (continued):
|
|
(iii)
|
Subsequent expenditure:
|
Subsequent expenditure is capitalized only when it
increases the future economic benefits embodied in the specific asset to which it relates. All other expenditures, including expenditure on internally generated goodwill and brands, are recognized in profit or loss as incurred.
Amortization is calculated over the cost of the asset less its
residual value.
Amortization is recognized in profit or loss on a straight-line basis over the estimated useful lives of
intangible assets from the date that they are available for use, since this most closely reflects the expected pattern of consumption of the future economic benefits embodied in the asset. The estimated useful lives for the current and comparative
periods are as follows:
|
|
|
Assets
|
|
Period
|
|
|
Patents
|
|
20 years
|
License
|
|
8 to 14 years
|
A financial asset not carried at fair value through profit
or loss is assessed at each reporting date to determine whether there is objective evidence that it is impaired. A financial asset is impaired if objective evidence, such as default or delinquency by a debtor, indicates that a loss event has
occurred after the initial recognition of the asset, and that the loss event had a negative effect on the estimated future cash flows of that asset that can be estimated reliably.
An impairment loss in respect of a financial asset measured at amortized cost is calculated as the difference between its
carrying amount and the present value of the estimated future cash flows discounted at the assets original effective interest rate. Losses are recognized in profit or loss and reflected in an allowance account against the financial asset. When
a subsequent event causes the amount of impairment loss to decrease, the decrease in impairment loss is reversed through profit or loss.
|
(ii)
|
Non-financial assets:
|
The carrying amounts of the Corporations
non-financial assets are reviewed at each reporting date to determine whether there is any indication of impairment. If any such indication exists, then the assets recoverable amount is estimated.
The recoverable amount of an asset or cash-generating unit is the greater of its value in use and its fair value less costs to
sell. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset. For the
purpose of impairment testing, assets that cannot be tested individually are grouped together into the smallest group of assets that generates cash inflows from continuing use that are largely independent of the cash inflows of other assets or
groups of assets (the cash-generating unit, or CGU).
F-14
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
3.
|
Significant accounting policies (continued):
|
|
(d)
|
Impairment (continued):
|
|
(ii)
|
Non-financial assets (continued):
|
The Corporations corporate assets do not generate separate cash
inflows. If there is an indication that a corporate asset may be impaired, then the recoverable amount is determined for the CGU to which the corporate asset belongs.
An impairment loss is recognized if the carrying amount of an asset or its CGU exceeds its estimated recoverable amount.
Impairment losses are recognized in profit or loss.
Impairment losses recognized in prior years are assessed at each
reporting date for any indications that the loss has decreased or no longer exists. An impairment loss is reversed if there has been a change in the estimates used to determine the recoverable amount. An impairment loss is reversed only to the
extent that the assets carrying amount does not exceed the carrying amount that would have been determined, net of depreciation or amortization, if no impairment loss had been recognized.
|
(i)
|
Short-term employee benefits:
|
Short-term employee benefit obligations are
measured on an undiscounted basis and are expensed as the related service is provided.
A liability is recognized for the
amount expected to be paid under short-term cash bonus or profit-sharing plans if the Corporation has a present legal or constructive obligation to pay this amount as a result of past service provided by the employee, and the obligation can be
estimated reliably.
|
(ii)
|
Share-based payment transactions:
|
The grant date fair value of share-based
payment awards granted to employees is recognized as an employee expense, with a corresponding increase in contributed surplus, over the period that the employees unconditionally become entitled to the awards. The grant date fair value takes into
consideration market performance conditions when applicable. The amount recognized as an expense is adjusted to reflect the number of awards for which the related service and non-market vesting conditions are expected to be met, such that the amount
ultimately recognized as an expense is based on the number of awards that do meet the related service and non-market performance conditions at the vesting date.
Share-based payment arrangements in which the Corporation receives goods or services as consideration for its own equity
instruments are accounted for as equity-settled share-based payment transactions, regardless of how the equity instruments are obtained by the Corporation.
|
(iii)
|
Termination benefits:
|
Termination benefits are recognized as an expense when
the Corporation is committed demonstrably, without realistic possibility of withdrawal, to a formal detailed plan to either terminate employment before the normal retirement date, or to provide termination benefits as a result of an offer made to
encourage voluntary redundancy. Termination benefits for voluntary redundancies are recognized as an expense if the Corporation has made an offer of voluntary redundancy, it is probable that the offer will be accepted, and the number of acceptances
can be estimated reliably. If benefits are payable more than 12 months after the reporting year, then they are discounted to their present value.
F-15
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
3.
|
Significant accounting policies (continued):
|
A provision is recognized if, as a result of a past event, the Corporation has a present legal or constructive obligation that
can be estimated reliably, and it is probable that an outflow of economic benefits will be required to settle the obligation. Provisions are determined by discounting the expected future cash flows at a pre-tax rate that reflects current market
assessments of the time value of money and the risks specific to the liability. The unwinding of the discount is recognized as finance cost.
A provision for onerous contracts is recognized when the expected benefits to be derived by the Corporation from a contract are
lower than the unavoidable cost of meeting its obligations under the contract. The provision is measured at the present value of the lower of the expected cost of terminating the contract and the expected net cost of continuing with the contract.
Before a provision is established, the Corporation recognizes any impairment loss on the assets associated with that contract.
|
(ii)
|
Contingent liability:
|
A contingent liability is a possible obligation that arises from past events and of which the existence will be confirmed only
by the occurrence or non-occurrence of one or more uncertain future events not within the control of the Corporation; or a present obligation that arises from past events (and therefore exists), but is not recognized because it is not probable that
a transfer or use of assets, provision of services or any other transfer of economic benefits will be required to settle the obligation; or the amount of the obligation cannot be estimated reliably.
Government grants are recorded as a reduction of the related expense or cost of the asset acquired. Government grants are
recognized when there is reasonable assurance that the Corporation has met the requirements of the approved grant program and there is reasonable assurance that the grant will be received.
Grants that compensate the Corporation for expenses incurred are recognized in profit or loss in reduction thereof on a
systematic basis in the same years in which the expenses are recognized. Grants that compensate the Corporation for the cost of an asset are recognized in profit or loss on a systematic basis over the useful life of the asset.
Payments made under operating leases are recognized in profit or loss on a straight-line basis over the term of the lease. Lease
incentives received are recognized as an integral part of the total lease expense, over the term of the lease.
Transactions in foreign currencies are translated into the functional currency at exchange rates at the dates of the
transactions. Monetary assets and liabilities denominated in foreign currencies at the reporting date are retranslated to the functional currency at the exchange rate at that date. The foreign currency gain or loss on monetary items is the
difference between amortized cost in the functional currency at the beginning of the period, adjusted for effective interest and payments during the period, and the amortized cost in foreign currency translated at the exchange rate at the end of the
reporting period. Foreign currency differences arising on retranslation are recognized in profit or loss.
F-16
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
3.
|
Significant accounting policies (continued):
|
|
(j)
|
Finance income and finance costs:
|
Finance income comprises interest income on funds invested. Interest income is recognized as it accrues in profit or loss, using
the effective interest method.
Finance costs comprise interest expense and accretion on borrowings, unwinding of the
discount on provisions and impairment losses recognized on financial assets. Borrowing costs that are not directly attributable to the acquisition, construction or production of a qualifying asset are recognized in profit or loss using the effective
interest method.
Foreign currency gains and losses are reported on a net basis.
The Corporation recognizes interest income as a component of investing activities and interest expense as a component of
financing activities in the statements of cash flows.
Income tax expense comprises current and deferred taxes. Current and deferred taxes are recognized in profit or loss except to
the extent that they relate to items recognized directly in equity or in other comprehensive income.
Current tax is the
expected tax payable or receivable on the taxable income or loss for the year, using tax rates enacted or substantively enacted at the reporting date, and any adjustment to tax payable in respect of previous years.
Deferred tax is recognized in respect of temporary differences between the carrying amounts of assets and liabilities for
financial reporting purposes and the amounts used for taxation purposes. Deferred tax is not recognized for temporary differences arising from the initial recognition of assets or liabilities in a transaction that is not a business combination and
that affects neither accounting nor taxable profit or loss. Deferred tax is measured at the tax rates that are expected to be applied to temporary differences when they reverse, based on the laws that have been enacted or substantively enacted by
the reporting date. Deferred tax assets and liabilities are offset if there is a legally enforceable right to offset current tax liabilities and assets, and they relate to income taxes levied by the same tax authority on the same taxable entity, or
on different tax entities, but they intend to settle current tax liabilities and assets on a net basis or their tax assets and liabilities will be realized simultaneously. A deferred tax asset is recognized for unused tax losses, tax credits and
deductible temporary differences, to the extent that it is probable that future taxable profits will be available against which they can be utilized. Deferred tax assets are reviewed at each reporting date and are reduced to the extent that it is no
longer probable that the related tax benefit will be realized.
The Corporation presents basic and diluted earnings per share (EPS) data for its Class A shares (or
Common Shares). Basic EPS is calculated by dividing the profit or loss attributable to the holders of Class A shares (Common Shares) of the Corporation by the weighted average number of Common Shares outstanding during the year,
adjusted for own shares held. Diluted EPS is determined by adjusting the profit or loss attributable to the holders of Class A shares (Common Shares) and the weighted average number of Class A shares (Common Shares) outstanding adjusted
for the effects of all dilutive potential Common Shares, which comprise warrants, rights and share options granted to employees.
An operating segment is a component of the Corporation that engages in business activities from which it may earn revenues and
incur expenses. The Corporation has one reportable operating segment: the development and commercialization of pharmaceutical applications of its licensed rights for cardiovascular diseases. The majority of the Corporations assets are located
in Canada, while one major production unit, with a carrying value of $2,394, is located in France.
F-17
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
3.
|
Significant accounting policies (continued):
|
|
(n)
|
Change in accounting policy:
|
Future accounting change:
The following new standards, and amendments to standards and interpretations, are not yet effective for the period ended
March 31, 2017, and have not been applied in preparing these financial statements.
New standards and
interpretations not yet adopted:
|
(i)
|
Financial instruments:
|
On July 24, 2014, the International Accounting Standards Board (IASB) issued the final version of IFRS 9,
Financial
Instruments,
which addresses the classification and measurement of financial assets and liabilities, impairment and hedge accounting, replacing IAS 39,
Financial Instruments: Recognition and Measurement
. IFRS 9 is effective for annual
periods beginning on or after January 1, 2018, with earlier adoption permitted. The Corporation intends to adopt IFRS 9 in its financial statements for the annual period beginning on April 1, 2018. The Corporation has not yet
assessed the impact of adoption of IFRS 9, and does not intend to early adopt IFRS 9 in its financial statements.
|
(ii)
|
Amendments to IFRS 2 Classification and Measurement of Share-Based Payment Transactions:
|
On June 20, 2016, the IASB issued amendments to IFRS 2,
Share-Based Payment
, clarifying how
to account for certain types of share-based payment transactions. The amendments apply for annual periods beginning on or after January 1, 2018. Earlier application is permitted. As a practical simplification, the amendments can be applied
prospectively. Retrospective, or early application is permitted if information is available without the use of hindsight. The amendments provide requirements on the accounting for: the effects of vesting and non-vesting conditions on the measurement
of cash-settled share-based payments; share-based payment transactions with a net settlement feature for withholding tax obligations; and a modification to the terms and conditions of a share-based payment that changes the classification of the
transaction from cash-settled to equity-settled. The Corporation intends to adopt the amendments to IFRS 2 in its financial statements for the annual period beginning on April 1, 2018. The Corporation has not yet assessed the impact of adoption
of the amendments of IFRS 2, and does not intend to early adopt these amendments in its financial statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes
|
|
|
March 31, 2017
|
|
|
February 28, 2017
(Unaudited)
|
|
|
February 29, 2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales tax receivables
|
|
|
|
|
|
|
89
|
|
|
|
83
|
|
|
|
182
|
|
Government assistance and tax credits receivable
|
|
|
6
|
|
|
|
115
|
|
|
|
81
|
|
|
|
217
|
|
Other receivables
|
|
|
|
|
|
|
2
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
206
|
|
|
|
166
|
|
|
|
399
|
|
F-18
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
|
(a)
|
Administrative and research and development expenses:
|
The Corporation was
charged by Neptune for the purchase of research supplies and for certain costs incurred by Neptune for the benefit of the Corporation, as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Thirteen-months
ended
|
|
Month ended
|
|
Twelve-months
ended
|
|
Year ended
|
|
Year ended
|
|
|
March 31,
2017
|
|
March 31,
2017
(Unaudited)
|
|
February 28,
2017
(Unaudited)
|
|
February 29,
2016
|
|
February 28,
2015
|
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
|
Research and development expenses
|
|
60
|
|
1
|
|
59
|
|
371
|
|
344
|
General and administrative expenses
|
|
618
|
|
41
|
|
577
|
|
790
|
|
876
|
|
|
678
|
|
42
|
|
636
|
|
1,161
|
|
1,220
|
The Corporation purchased from the parent company research and development supplies
totaling $113, of which $73 as at March 31, 2017 and as at February 28, 2017 (unaudited) is recorded in prepaid expenses and will be expensed as used.
Where Neptune incurs specific incremental costs for the benefit of the Corporation, it charges those amounts directly. Costs
that benefit more than one entity of the Group are charged by allocating a fraction of costs incurred by Neptune that is commensurate to the estimated fraction of services or benefits received by each entity for those items.
These charges do not represent all charges incurred by Neptune that may have benefited the Corporation. Also, these charges do
not necessarily represent the cost that the Corporation would otherwise need to incur, should it not receive these services or benefits through the shared resources of Neptune.
On January 7, 2016 Neptune announced the acquisition of
Biodroga Nutraceuticals Inc. As part of this transaction, the Corporation pledged an amount of $2 million (Committed Funds) to partly guarantee the financing for the said transaction (Pledge Agreement). Neptune had agreed to
pay Acasti an annual fee on the Committed Funds outstanding at an annual rate of 9% during the first six months and 11% for the remaining term of the Pledge Agreement. On September 20, 2016, Neptune fully released the pledged amount. The
Corporation recognized interest revenue in the amount of $89 for the thirteen-month period ended March 31, 2017, nil (unaudited) for the month ended March 31, 2017, $89 (unaudited) for the twelve-month period ended February 28, 2017
and $27 for the year ended February 29, 2016.
|
(c)
|
Payable to parent corporation:
|
Payable to parent corporation, primarily for
general and administrative shared services, has no specified maturity date for payment or reimbursement and does not bear interest.
|
(d)
|
Key management personnel compensation:
|
The key management personnel are the officers of the
Corporation, the members of the Board of Directors of the Corporation and of the parent company. They control in the aggregate less than 2% of the voting shares of the Corporation (1% in 2016 and 2% in 2015).
F-19
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
5.
|
Related parties (continued):
|
|
(d)
|
Key management personnel compensation (continued):
|
Key management personnel
compensation includes the following for the thirteen-month and one-month periods ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015:
|
|
|
|
|
|
|
|
|
|
|
|
|
Thirteen-months
ended
|
|
Month ended
|
|
Twelve-months
ended
|
|
Year ended
|
|
Year ended
|
|
|
March 31,
2017
|
|
March 31,
2017
(Unaudited)
|
|
February 28,
2017
(Unaudited)
|
|
February 29,
2016
|
|
February 28,
2015
|
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
|
Short-term benefits
|
|
1,311
|
|
202
|
|
1,109
|
|
688
|
|
742
|
Severance
|
|
|
|
|
|
|
|
103
|
|
175
|
Share-based compensation costs
|
|
619
|
|
78
|
|
541
|
|
120
|
|
1,339
|
|
|
1,930
|
|
280
|
|
1,650
|
|
911
|
|
2,256
|
6.
|
Government assistance:
|
Government assistance is comprised of a
government grant from the federal government and research and development investment tax credits receivable from the provincial government which relate to qualifiable research and development expenditures under the applicable tax laws. The amounts
recorded as receivables are subject to a government tax audit and the final amounts received may differ from those recorded.
Unrecognized
federal tax credits may be used to reduce future income tax and expire as follows:
|
|
|
|
|
$
|
|
|
2029
|
|
11
|
2030
|
|
30
|
2031
|
|
45
|
2032
|
|
431
|
2033
|
|
441
|
2034
|
|
436
|
2035
|
|
519
|
2036
|
|
286
|
2037
|
|
251
|
|
|
2,450
|
F-20
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Furniture and
office equipment
|
|
|
Computer
equipment
|
|
|
Laboratory
equipment
|
|
|
Production
equipment
|
|
|
Total
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
Cost:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at February 28, 2014
|
|
|
59
|
|
|
|
3
|
|
|
|
25
|
|
|
|
|
|
|
|
87
|
|
Additions
|
|
|
|
|
|
|
|
|
|
|
35
|
|
|
|
|
|
|
|
35
|
|
Balance at February 28, 2015
|
|
|
59
|
|
|
|
3
|
|
|
|
60
|
|
|
|
|
|
|
|
122
|
|
Additions
|
|
|
|
|
|
|
|
|
|
|
276
|
|
|
|
|
|
|
|
276
|
|
Balance at February 29, 2016
|
|
|
59
|
|
|
|
3
|
|
|
|
336
|
|
|
|
|
|
|
|
398
|
|
Additions for the twelve-month period (Unaudited)
|
|
|
|
|
|
|
8
|
|
|
|
186
|
|
|
|
2,578
|
|
|
|
2,772
|
|
Balance at February 28, 2017 (Unaudited)
|
|
|
59
|
|
|
|
11
|
|
|
|
522
|
|
|
|
2,578
|
|
|
|
3,170
|
|
Additions for the one-month period (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43
|
|
|
|
43
|
|
Additions for the thirteen-month period
|
|
|
|
|
|
|
8
|
|
|
|
186
|
|
|
|
2,621
|
|
|
|
2,815
|
|
Balance at March 31, 2017
|
|
|
59
|
|
|
|
11
|
|
|
|
522
|
|
|
|
2,621
|
|
|
|
3,213
|
|
|
|
|
|
|
|
Accumulated depreciation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at February 28, 2014
|
|
|
45
|
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
48
|
|
Depreciation for the year
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4
|
|
Balance at February 28, 2015
|
|
|
49
|
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
52
|
|
Depreciation for the year
|
|
|
3
|
|
|
|
|
|
|
|
56
|
|
|
|
|
|
|
|
59
|
|
Balance at February 29, 2016
|
|
|
52
|
|
|
|
3
|
|
|
|
56
|
|
|
|
|
|
|
|
111
|
|
Depreciation for the twelve-month period
(Unaudited)
|
|
|
7
|
|
|
|
1
|
|
|
|
129
|
|
|
|
52
|
|
|
|
189
|
|
Balance at February 28, 2017 (Unaudited)
|
|
|
59
|
|
|
|
4
|
|
|
|
185
|
|
|
|
52
|
|
|
|
300
|
|
Depreciation for the one-month period (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
11
|
|
|
|
21
|
|
|
|
32
|
|
Depreciation for thirteen-month period
|
|
|
7
|
|
|
|
1
|
|
|
|
140
|
|
|
|
73
|
|
|
|
221
|
|
Balance at March 31, 2017
|
|
|
59
|
|
|
|
4
|
|
|
|
196
|
|
|
|
73
|
|
|
|
332
|
|
|
|
|
|
|
|
Net carrying amounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
February 29, 2016
|
|
|
7
|
|
|
|
|
|
|
|
280
|
|
|
|
|
|
|
|
287
|
|
February 28, 2017 (Unaudited)
|
|
|
|
|
|
|
7
|
|
|
|
337
|
|
|
|
2,526
|
|
|
|
2,870
|
|
March 31, 2017
|
|
|
|
|
|
|
7
|
|
|
|
326
|
|
|
|
2,548
|
|
|
|
2,881
|
|
Depreciation expense for the thirteen-month and one-month periods ended March 31,
2017 and twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015 has been recorded in research and development expenses in the statements of earnings and comprehensive loss.
F-21
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian dollars, except where noted and for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents
|
|
License
|
|
Total
|
|
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
Cost:
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at February 28, 2014
|
|
|
227
|
|
|
|
24,330
|
|
|
|
24,557
|
|
Additions
|
|
|
51
|
|
|
|
|
|
|
|
51
|
|
Balance at February 28, 2015
|
|
|
278
|
|
|
|
24,330
|
|
|
|
24,608
|
|
Additions
|
|
|
84
|
|
|
|
|
|
|
|
84
|
|
Balance at February 29,
2016, February 28, 2017
(Unaudited) and March 31, 2017
|
|
|
362
|
|
|
|
24,330
|
|
|
|
24,692
|
|
|
|
|
|
Accumulated amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at February 28, 2014
|
|
|
1
|
|
|
|
4,780
|
|
|
|
4,781
|
|
Amortization for the year
|
|
|
9
|
|
|
|
2,322
|
|
|
|
2,331
|
|
Balance at February 28, 2015
|
|
|
10
|
|
|
|
7,102
|
|
|
|
7,112
|
|
Amortization for the year
|
|
|
13
|
|
|
|
2,323
|
|
|
|
2,336
|
|
Impairment loss
|
|
|
339
|
|
|
|
|
|
|
|
339
|
|
Balance at February 29, 2016
|
|
|
362
|
|
|
|
9,425
|
|
|
|
9,787
|
|
Amortization for the twelve-month period
(Unaudited)
|
|
|
|
|
|
|
2,323
|
|
|
|
2,323
|
|
Balance at February 28, 2017 (Unaudited)
|
|
|
362
|
|
|
|
11,748
|
|
|
|
12,110
|
|
Amortization for the one-month period (Unaudited)
|
|
|
|
|
|
|
194
|
|
|
|
194
|
|
Amortization for the thirteen-month period
|
|
|
|
|
|
|
2,517
|
|
|
|
2,517
|
|
Balance at March 31, 2017
|
|
|
362
|
|
|
|
11,942
|
|
|
|
12,304
|
|
|
|
|
|
Net carrying amounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
February 29, 2016
|
|
|
|
|
|
|
14,905
|
|
|
|
14,905
|
|
February 28, 2017 (Unaudited)
|
|
|
|
|
|
|
12,582
|
|
|
|
12,582
|
|
March 31, 2017
|
|
|
|
|
|
|
12,388
|
|
|
|
12,388
|
|
Amortization expense and impairment loss for the thirteen-month and one-month periods
ended March 31, 2017, the twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015 have been recorded in research and development expenses in the statements of earnings
and comprehensive loss.
F-22
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian dollars, except where noted and for share and per share amounts)
9.
|
Trade and other payables:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
|
February 28, 2017
(Unaudited)
|
|
|
February 29, 2016
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
Trade payables
|
|
|
259
|
|
|
|
534
|
|
|
|
375
|
|
Accrued liabilities and other payables
|
|
|
1,354
|
|
|
|
1,372
|
|
|
|
543
|
|
Employee salaries and benefits payable
|
|
|
513
|
|
|
|
484
|
|
|
|
208
|
|
|
|
|
2,126
|
|
|
|
2,390
|
|
|
|
1,126
|
|
The Corporations exposure to currency and liquidity risks related to trade and other payables is
presented in Note 19.
10.
|
Derivative warrant liabilities:
|
Warrants issued as part of a public
offering of units composed of class A share (Common Share) and Common Share purchase warrants in 2014 are derivative liabilities (Derivative warrant liabilities) for accounting purposes due to the currency of the exercise price being
different from the Corporations functional currency.
The derivative warrant liabilities are measured at fair value at
each reporting period and the reconciliation of changes in fair value is presented in the following table:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thirteen-month period
|
|
|
Month ended
|
|
|
Twelve-month period
|
|
|
Year ended
|
|
|
|
ended March 31, 2017
|
|
|
March 31, 2017
(Unaudited)
|
|
|
ended February 28, 2017
(Unaudited)
|
|
|
February 29,
2016
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
Balance beginning of period
|
|
|
156
|
|
|
|
187
|
|
|
|
156
|
|
|
|
2,357
|
|
Change in fair value of derivative warrant
liabilities
|
|
|
53
|
|
|
|
22
|
|
|
|
31
|
|
|
|
(2,201)
|
|
Balance end of period
|
|
|
209
|
|
|
|
209
|
|
|
|
187
|
|
|
|
156
|
|
The fair value of the derivative warrant liabilities was estimated using the Black-Scholes
option pricing model and based on the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
|
|
|
|
February 28, 2017
(Unaudited)
|
|
|
|
|
|
February 29, 2016
|
|
|
|
|
|
|
|
Exercise price
|
|
|
US $1.50
|
|
|
|
|
|
|
|
US $1.50
|
|
|
|
|
|
|
|
US $1.50
|
|
Share price
(1)
|
|
|
US $1.36
|
|
|
|
|
|
|
|
US $1.25
|
|
|
|
|
|
|
|
US $1.50
|
|
Dividend
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk-free interest
|
|
|
1.22%
|
|
|
|
|
|
|
|
1.24%
|
|
|
|
|
|
|
|
0.87%
|
|
Estimated life
|
|
|
1.68 years
|
|
|
|
|
|
|
|
1.76 years
|
|
|
|
|
|
|
|
2.76 years
|
|
Expected volatility
|
|
|
108.35%
|
|
|
|
|
|
|
|
107.36%
|
|
|
|
|
|
|
|
76.34%
|
|
|
(1)
|
In order to obtain one Common Share, 10 warrants must be exercised.
|
The fair value of the warrants issued was determined to be $0.11 per share issuable as at March 31, 2017 and $0.10
(unaudited) per share issuable as at February 28, 2017 ($0.09 per share issuable as at February 29, 2016).
F-23
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian dollars, except where noted and for share and per share amounts)
11.
|
Unsecured convertible debentures
|
Concurrent with the Public Offering described in note 12, on February 21,
2017, the Company issued $2,000 aggregate principal amount of unsecured convertible debentures maturing February 21, 2020 and contingent warrants to acquire up to 1,052,630 Common Shares (the Private Placement). The principal may be
prepaid, in whole or in part, at any time and from time to time, in cash, at the sole discretion of the Corporation
.
The debentures are convertible into Common Shares at anytime by the holder at a fixed price of $1.90 per Common Share except
if the Corporation pays before the maturity, all or any portion of the convertible debentures. Should the Corporation pay all or any portion of the convertible debenture before maturity, then warrants become exercisable at $1.90 per Common Share for
the equivalent convertible debenture amount prepaid. The contingent warrants will be exercisable for the remaining term of the convertible debt for the same price as the conversion options. The unsecured convertible debentures were issued at a
discount of 3.5% to the principal amount, for aggregate gross proceeds of $1,930.
The convertible debentures provide the
Corporation an accelerated conversion right whereby the Corporation may, at any time at least four months after the date of issuance of the convertible debentures, accelerate the conversion of the debentures to Common Shares in the event that the
volume weighted average price of the Corporations Common Shares on the TSX Venture Exchange is equal to or exceeds $2.65, subject to customary adjustment provisions, during 20 consecutive trading days.
The interest to be paid on the convertible debentures under the terms of the agreement is 8% per annum, payable on a
quarterly basis in cash or Common Shares of the Corporation or a combination thereof, commencing on March 31, 2017. The decision to pay the interest due in cash or shares is at the discretion of the Corporation and the number of Common Shares
to be issued will be calculated at the current market price as at the close of business on the day before the interest payment is to be made. Payment in shares shall be at a floor price of $0.10 per share, with the difference between the amount
payable and the amount computed at floor price payable in cash.
The proceeds of the Private Placement were split between
the liability and the equity at the time of issuance of the Private Placement. Both the conversion option and contingent warrants are considered the equity component of the Private Placement. The fair value of the liability component was determined
through a discounted cash flow analysis using a discount rate of 20% that was set based on a similar debt and maturity considering the Corporations credit risk excluding the conversion option and contingent warrants. The amount allocated to
the equity component is the residual amount after deducting the fair value of the financial liability component from the fair value of the entire compound instrument. Subsequent to initial recognition, the liability is measured at amortized cost
calculated using the effective interest rate method and will accrete up to the principal balance at maturity. The interest accretion is presented as a financial expense. The equity component is not re-measured. Transaction costs were allocated to
the components in proportion to their initial carrying amounts. The portion allocated to the liability was recognized as a reduction of the debt whereas the portion allocated to other equity was recognized as a reduction to other equity.
The fair value of the liability portion at the time of issuance was determined to be $1,519 and the transaction costs and debt
discount amounted to $134, of which $30 is still unpaid as at March 31, 2017. The residual of the proceeds allocated to the equity component amounted to $481 and the transactions costs amounted to $43, of which $10 is unpaid at March 31,
2017.
F-24
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian dollars, except where noted and for share and per share amounts)
11.
|
Unsecured convertible debentures (continued):
|
The split between the liability and equity component portions of the Private
Placement are summarized below:
|
|
|
|
|
|
|
|
|
Liability component
|
|
Equity component
|
|
Total Private Placement
|
|
|
$
|
|
$
|
|
$
|
|
|
|
|
Components at date of issue
|
|
1,519
|
|
481
|
|
2,000
|
Transaction costs and debt discount
|
|
(134)
|
|
(43)
|
|
(177)
|
Deferred income tax expense (note 18)
|
|
|
|
(129)
|
|
(129)
|
Effective interest for the twelve-month period (Unaudited)
|
|
8
|
|
|
|
8
|
Interest payable (Unaudited)
|
|
(4)
|
|
|
|
(4)
|
February 28, 2017 (Unaudited)
|
|
1,389
|
|
309
|
|
1,698
|
Effective interest for the one-month period (Unaudited)
|
|
31
|
|
|
|
31
|
Interest payable (Unaudited)
|
|
(14)
|
|
|
|
(14)
|
Effective interest for the thirteen-month period
|
|
39
|
|
|
|
39
|
Interest payable
|
|
(18)
|
|
|
|
(18)
|
March 31, 2017
|
|
1,406
|
|
309
|
|
1,715
|
12.
|
Capital and other components of equity
|
Authorized capital stock:
Unlimited number of shares:
|
Ø
|
|
Class A shares (Common Shares), voting (one vote per share), participating and without par value
|
|
Ø
|
|
Class B shares, voting (ten votes per share), non-participating, without par value and maximum annual
non-cumulative dividend of 5% on the amount paid for said shares. Class B shares are convertible, at the holders discretion, into Class A shares (Common Shares), on a one-for-one basis, and Class B shares are redeemable at the
holders discretion for $0.80 per share, subject to certain conditions.
(1)
|
|
Ø
|
|
Class C shares, non-voting, non-participating, without par value and maximum annual non-cumulative dividend of
5% on the amount paid for said shares. Class C shares are convertible, at the holders discretion, into Class A shares (Common Shares), on a one-for-one basis, and Class C shares are redeemable at the holders discretion for $0.20 per
share, subject to certain conditions.
(1)
|
|
Ø
|
|
Class D and E shares, non-voting, non-participating, without par value and maximum monthly non-cumulative
dividend between 0.5% and 2% on the amount paid for said shares. Class D and E shares are convertible, at the holders discretion, into Class A shares (Common Shares), on a one-for-one basis, and Class D and E shares are redeemable at the
holders discretion, subject to certain conditions.
(1)
|
(1)
None issued and outstanding
F-25
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian dollars, except where noted and for share and per share amounts)
12.
|
Capital and other components of equity (continued):
|
|
(b)
|
Public offering 2017:
|
Concurrent with the private placement described in Note
11, on February 21, 2017, the Corporation closed a public offering (Public Offering) issuing 3,930,518 units of Acasti (Units) at a price of $1.45 per Unit for gross proceeds of $5,699. Each Unit consists of one class A
share (Common Share) and one half of one class A or common share purchase warrant. Each whole warrant entitles the holder thereof to purchase one common share at an exercise price of $2.15 per common share, at any time until February 21, 2022.
The Units issued as part of the public offering are considered equity instruments. The transaction costs associated with the Public Offering amounted to $1,190, of which $381 remains unpaid as at March 31, 2017 (February 28, 2017 - $416
(unaudited)). The proceeds and transaction costs were allocated to share capital.
As part of the transaction, the Company
also issued broker warrants (the Broker Warrants) to purchase up to 234,992 Common Shares. Each Broker Warrant entitles the holder thereof to acquire one Common Share of the Corporation at an exercise price of $2.15 per common share, at
any time until February 21, 2018. The broker warrants are considered for compensation to non-employees under IFRS 2, stock-based compensation, and are accounted for at fair value through contributed surplus. To determine the fair value of the
Broker Warrants, the Black-Scholes pricing model was used. The total costs associated with the Broker Warrants amounted to $144 and were allocated to share capital.
The warrants issued as part of the Units of the Public Offering and the broker warrants include an Acceleration
Right, related to the Corporations right to accelerate the expiry date of the warrants. The Acceleration Right clause means the right of the Corporation to accelerate the expiry date to a date that is not less than 30 days following
delivery of the acceleration notice if, at any time at least four months after the effective date, the volume weighted average trading price of the common shares equals or exceeds $2.65 for a period of 20 consecutive trading days on the TSXV.
Furthermore, as part of the February 2017 Public Offering and convertible debt transactions, a total of 60,000 Common Shares
were issued as equity settled share-based payments for services received from an employee of the parent at a price of $1.57 per share for a total cost of $94. The equity settled share-based payment costs have been allocated to share capital for a
cost that amounted to $85 and to debt for a cost that amounted to $9 based on relative value.
The value of the broker
warrants was estimated using the Black-Scholes option pricing model and based on the following assumptions:
|
|
|
|
|
|
|
Thirteen-month period ended
March 31, 2017
|
|
|
|
Exercise price
|
|
|
$2.15
|
|
Share price
|
|
|
$1.70
|
|
Dividend
|
|
|
|
|
Risk-free interest
|
|
|
0.79%
|
|
Estimated life
|
|
|
1.00 year
|
|
Expected volatility
|
|
|
112.09%
|
|
On February 5, 2016, 50,000 shares were issued on the
settlement of a liability. An amount of $102, net of share issuance costs of $1, was recorded in share capital.
F-26
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian dollars, except where noted and for share and per share amounts)
12.
|
Capital and other components of equity (continued):
|
The warrants of the Corporation are composed of the following as at
March 31, 2017, February 28, 2017, February 29, 2016 and February 28, 2015:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2017
|
|
|
|
|
|
February 28,
2017
(Unaudited)
|
|
|
|
|
|
February 29,
2016
|
|
|
|
|
|
February 28,
2015
|
|
|
|
Number outstanding
|
|
|
Amount
|
|
|
Number
outstanding
|
|
|
Amount
|
|
|
Number
outstanding
|
|
|
Amount
|
|
|
Number
outstanding
|
|
|
Amount
|
|
|
|
|
|
|
$
|
|
|
|
|
|
$
|
|
|
|
|
|
$
|
|
|
|
|
|
$
|
|
Liability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series 8 Public offering Warrants 2014 (note 10)
(i)
|
|
|
18,400,000
|
|
|
|
209
|
|
|
|
18,400,000
|
|
|
|
187
|
|
|
|
18,400,000
|
|
|
|
156
|
|
|
|
18,400,000
|
|
|
|
2,357
|
|
|
|
|
18,400,000
|
|
|
|
209
|
|
|
|
18,400,000
|
|
|
|
187
|
|
|
|
18,400,000
|
|
|
|
156
|
|
|
|
18,400,000
|
|
|
|
2,357
|
|
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Public offering warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Public offering warrants 2017 (ii)
|
|
|
1,965,259
|
|
|
|
|
|
|
|
1,965,259
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series 2017-BW Broker warrants (iii)
|
|
|
234,992
|
|
|
|
144
|
|
|
|
234,992
|
|
|
|
144
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Private Placement contingent warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017 Unsecured convertible debenture conversion option and contingent warrants (iv)
|
|
|
1,052,630
|
|
|
|
309
|
|
|
|
1,052,630
|
|
|
|
309
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series 9 Private Placement warrants 2014 (v)
|
|
|
161,654
|
|
|
|
|
|
|
|
161,654
|
|
|
|
|
|
|
|
161,654
|
|
|
|
|
|
|
|
161,654
|
|
|
|
|
|
|
|
|
3,414,535
|
|
|
|
453
|
|
|
|
3,414,535
|
|
|
|
453
|
|
|
|
161,654
|
|
|
|
|
|
|
|
161,654
|
|
|
|
|
|
|
(i)
|
In order to obtain one Common Share of the Corporation at an exercise price of US$15.00, 10 warrants must be
exercised. Warrants expire on December 3, 2018.
|
|
(ii)
|
Warrant to acquire one Common Share of the Corporation at an exercise price of $2.15, expiring on
February 21, 2022.
|
|
(iii)
|
Warrant to acquire one Common Share of the Corporation at an exercise price of $2.15 expiring on
February 21, 2018.
|
|
(iv)
|
Warrant to acquire one Common Share of the Corporation at an exercise price of $1.90 expiring on
February 21, 2020, net of deferred tax expense of $129.
|
|
(v)
|
Warrant to acquire one Common Share of the Corporation at an exercise price of $13.30, expiring on
December 3, 2018.
|
F-27
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thirteen-months
ended
|
|
|
Month ended
|
|
|
Twelve-month
period ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
March 31,
2017
|
|
|
March 31,
2017
(Unaudited)
|
|
|
February 28,
2017
(Unaudited)
|
|
|
February 29,
2016
|
|
|
February 28,
2015
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
Salaries and other short-term employee benefits
|
|
|
2,483
|
|
|
|
214
|
|
|
|
2,269
|
|
|
|
1,902
|
|
|
|
1,554
|
|
Share-based compensation costs
|
|
|
674
|
|
|
|
86
|
|
|
|
588
|
|
|
|
309
|
|
|
|
1,553
|
|
Severance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
210
|
|
|
|
171
|
|
|
|
|
3,157
|
|
|
|
300
|
|
|
|
2,857
|
|
|
|
2,421
|
|
|
|
3,278
|
|
14.
|
Financial (expenses) income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thirteen-months
ended
|
|
|
Month ended
|
|
|
Twelve-month
period ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2017
|
|
|
March 31,
2017
(Unaudited)
|
|
|
February 28,
2017
(Unaudited)
|
|
|
February 29,
2016
|
|
|
February 28,
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
Interest income
|
|
|
125
|
|
|
|
6
|
|
|
|
119
|
|
|
|
73
|
|
|
|
87
|
|
Foreign exchange gain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,023
|
|
|
|
1,833
|
|
Financial income
|
|
|
125
|
|
|
|
6
|
|
|
|
119
|
|
|
|
1,096
|
|
|
|
1,920
|
|
|
|
|
|
|
|
Foreign exchange loss
|
|
|
(180)
|
|
|
|
(3)
|
|
|
|
(177)
|
|
|
|
|
|
|
|
|
|
Interest on convertible debenture
|
|
|
(39)
|
|
|
|
(31)
|
|
|
|
(8)
|
|
|
|
|
|
|
|
|
|
Other charges
|
|
|
(19)
|
|
|
|
(1)
|
|
|
|
(18)
|
|
|
|
(2)
|
|
|
|
(4)
|
|
Financial expenses
|
|
|
(238)
|
|
|
|
(35)
|
|
|
|
(203)
|
|
|
|
(2)
|
|
|
|
(4)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial (expenses) income
|
|
|
(113)
|
|
|
|
(29)
|
|
|
|
(84)
|
|
|
|
1,094
|
|
|
|
1,916
|
|
F-28
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
15.
|
Share-based payments:
|
At March 31, 2017, the Corporation has the following
share-based payment arrangement:
|
(a)
|
Corporation stock option plan:
|
The Corporation has in place a stock option plan
for directors, officers, employees and consultants of the Corporation. The plan provides for the granting of options to purchase Class A shares (Common Shares). The exercise price of the stock options granted under this plan is not lower than
the closing price of the shares listed on the TSXV at the close of markets the day preceding the grant. Under this plan, the maximum number of Class A shares (Common Shares) that may be issued upon exercise of options granted under the plan is
2,142,407, representing 20% of the number of Class A shares (Common Shares) issued and outstanding as at February 29, 2016. The terms and conditions for acquiring and exercising options are set by the Corporations Board of Directors,
subject among others, to the following limitations: the term of the options cannot exceed ten years and every stock option granted under the stock option plan will be subject to conditions no less restrictive than a minimum vesting period of 18
months and a gradual and equal acquisition of vesting rights not shorter than on a quarterly basis. The total number of shares issued to any one consultant cannot exceed 2% of the Corporations total issued and outstanding shares. The
Corporation is not authorized to grant such number of options under the stock option plan that could result in a number of Class A shares (Common Shares) issuable pursuant to options granted to (a) related persons exceeding 10% of the
Corporations issued and outstanding Class A shares (Common Shares) (on a non-diluted basis) on the date an option is granted, or (b) any one eligible person in a twelve month period exceeding 5% of the Corporations issued and
outstanding Class A shares (Common Shares) (on a non-diluted basis) on the date an option is granted.
The following
tables summarize information about activities within the stock option plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
Thirteen-month period ended
|
|
|
|
March 31, 2017
|
|
|
|
|
|
|
|
|
Weighted average
exercise price
|
|
|
Number of
options
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
|
|
|
|
Outstanding at beginning of period
|
|
|
13.52
|
|
|
|
454,151
|
|
Granted
|
|
|
1.69
|
|
|
|
1,300,400
|
|
Forfeited
|
|
|
13.27
|
|
|
|
(190,138
|
)
|
Expired
|
|
|
15.38
|
|
|
|
(139,625
|
)
|
|
|
Outstanding at end of period
|
|
|
2.58
|
|
|
|
1,424,788
|
|
|
|
|
|
|
Exercisable at end of period
|
|
|
6.44
|
|
|
|
238,482
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Month ended
|
|
|
Twelve-month period ended
|
|
|
|
March 31, 2017
(Unaudited)
|
|
|
February 28, 2017
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
exercise price
|
|
|
Number of
options
|
|
|
Weighted average
exercise price
|
|
|
Number of
options
|
|
|
|
|
|
|
$
|
|
|
|
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at beginning of period
|
|
|
2.59
|
|
|
|
1,427,288
|
|
|
|
13.52
|
|
|
|
454,151
|
|
Granted
|
|
|
|
|
|
|
|
|
|
|
1.69
|
|
|
|
1,300,400
|
|
Forfeited
|
|
|
11.50
|
|
|
|
(2,500
|
)
|
|
|
13.29
|
|
|
|
(187,638
|
)
|
Expired
|
|
|
|
|
|
|
|
|
|
|
15.38
|
|
|
|
(139,625
|
)
|
|
|
Outstanding at end of period
|
|
|
2.58
|
|
|
|
1,424,788
|
|
|
|
2.59
|
|
|
|
1,427,288
|
|
|
|
|
|
|
|
|
Exercisable at end of period
|
|
|
6.44
|
|
|
|
238,482
|
|
|
|
6.49
|
|
|
|
240,982
|
|
|
|
F-29
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
15.
|
Share-based payments (continued):
|
|
(a)
|
Corporation stock option plan (continued):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
February 29, 2016
|
|
|
February 28, 2015
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
exercise price
|
|
|
Number of
options
|
|
|
Weighted average
exercise price
|
|
|
Number of
options
|
|
|
|
|
|
|
$
|
|
|
|
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at beginning of year
|
|
|
15.33
|
|
|
|
429,625
|
|
|
|
15.72
|
|
|
|
491,100
|
|
Granted
|
|
|
4.65
|
|
|
|
109,188
|
|
|
|
9.51
|
|
|
|
51,250
|
|
Exercised
|
|
|
2.50
|
|
|
|
(250
|
)
|
|
|
2.50
|
|
|
|
(20,000
|
)
|
Forfeited
|
|
|
9.40
|
|
|
|
(66,912
|
)
|
|
|
14.90
|
|
|
|
(22,725
|
)
|
Expired
|
|
|
18.57
|
|
|
|
(17,500
|
)
|
|
|
18.00
|
|
|
|
(10,000
|
)
|
Cancelled
|
|
|
|
|
|
|
|
|
|
|
17.50
|
|
|
|
(60,000
|
)
|
|
|
Outstanding at end of year
|
|
|
13.52
|
|
|
|
454,151
|
|
|
|
15.33
|
|
|
|
429,625
|
|
|
|
|
|
|
|
|
Exercisable at end of year
|
|
|
15.28
|
|
|
|
375,563
|
|
|
|
15.48
|
|
|
|
332,039
|
|
|
|
The weighted average of the fair value of the options granted to employees and directors
of the Company during the thirteen-month period ended March 31, 2017 is $1.40 and during the twelve-month period ended February 28, 2017 is $1.40 (unaudited) (2016 -$2.14 and 2015 - $3.52). There were no options granted during the
month ended March 31, 2017 and no options granted to consultants during the thirteen-month period ended March 31, 2017 and years ended February 29, 2016 and February 28, 2015.
No options were exercised during the thirteen-month period ended March 31, 2017. The weighted average share price at the
date of exercise for share options exercised during the year ended February 29, 2016 was $4.20 (2015 - $9.20). Stock-based compensation recognized under this plan for the thirteen-month and one-month periods ended March 31, 2017 amounted
to $674 and $86 (unaudited), respectively and amounted to $588 (unaudited) for the twelve-month period ended February 28, 2017 (2016 - $234 and 2015 - $526).
The fair value of options granted was estimated using the Black-Scholes option pricing model, resulting in the following
weighted average assumptions for options granted during the periods ended:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thirteen-month
period ended
|
|
|
Twelve-month
Period ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
|
|
March 31,
2017
|
|
|
February 28, 2017
(Unaudited)
|
|
|
February 29, 2016
|
|
|
February 28, 2015
|
|
|
|
|
|
|
|
|
Exercise price
|
|
|
$1.69
|
|
|
|
$1.69
|
|
|
|
$4.65
|
|
|
|
$9.51
|
|
Share price
|
|
|
$1.69
|
|
|
|
$1.69
|
|
|
|
$4.65
|
|
|
|
$9.51
|
|
Dividend
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk-free interest
|
|
|
0.87%
|
|
|
|
0.87%
|
|
|
|
0.66%
|
|
|
|
1.14%
|
|
Estimated life
|
|
|
4.94 years
|
|
|
|
4.94 years
|
|
|
|
4.20 years
|
|
|
|
3.00 years
|
|
Expected volatility
|
|
|
123.54%
|
|
|
|
123.54%
|
|
|
|
65.63%
|
|
|
|
60.34%
|
|
|
|
The expected life of the stock options is based on historical data and current expectation
and is not necessarily indicative of exercise patterns that may occur. The expected volatility reflects the assumption that the historical volatility over a period similar to the life of the options is indicative of future trends, which may also not
necessarily be the actual outcome.
F-30
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
15.
|
Share-based payments (continued):
|
|
(a)
|
Corporation stock option plan (continued):
|
The following tables summarize the status of the outstanding and exercisable options of the
Corporation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
|
|
Options outstanding
|
|
|
|
|
|
Exercisable options
|
|
Exercise price
|
|
Weighted
remaining
contractual life
outstanding
|
|
|
Number of
options
outstanding
|
|
|
|
|
|
Weighed
average
exercise price
$
|
|
|
Number of
options
exercisable
|
|
|
|
|
|
|
|
$1.56 - $1.61
|
|
|
6.11
|
|
|
|
525,000
|
|
|
|
|
|
|
|
1.56
|
|
|
|
131,250
|
|
$1.62 - $1.82
|
|
|
9.90
|
|
|
|
465,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$1.83 - $2.25
|
|
|
6.16
|
|
|
|
286,700
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$2.26 - $5.65
|
|
|
4.08
|
|
|
|
79,588
|
|
|
|
|
|
|
|
3.84
|
|
|
|
38,732
|
|
$5.66 - $21.00
|
|
|
0.64
|
|
|
|
68,500
|
|
|
|
|
|
|
|
17.26
|
|
|
|
68,500
|
|
|
|
|
|
|
|
|
|
|
6.98
|
|
|
|
1,424,788
|
|
|
|
|
|
|
|
6.44
|
|
|
|
238,482
|
|
|
|
|
|
February 28, 2017 (Unaudited)
|
|
|
|
Options outstanding
|
|
|
|
|
|
Exercisable options
|
|
Exercise price
|
|
Weighted
remaining
contractual life
Outstanding
|
|
|
Number of
options
Outstanding
|
|
|
|
|
|
Weighed
average
exercise price
$
|
|
|
Number of
options
exercisable
|
|
|
|
|
|
|
|
$1.56 - $1.61
|
|
|
6.20
|
|
|
|
525,000
|
|
|
|
|
|
|
|
1.56
|
|
|
|
131,250
|
|
$1.62 - $1.82
|
|
|
9.99
|
|
|
|
465,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$1.83 - $2.25
|
|
|
6.25
|
|
|
|
286,700
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$2.26 - $5.65
|
|
|
4.17
|
|
|
|
79,588
|
|
|
|
|
|
|
|
3.84
|
|
|
|
38,732
|
|
$5.66 - $21.00
|
|
|
0.71
|
|
|
|
71,000
|
|
|
|
|
|
|
|
17.06
|
|
|
|
71,000
|
|
|
|
|
|
|
|
|
|
|
7.06
|
|
|
|
1,427,288
|
|
|
|
|
|
|
|
6.49
|
|
|
|
240,982
|
|
Share-based payment transactions and broker warrants:
The fair value of share-based payment transaction is measured using the Black-Scholes valuation model. Measurement inputs
include share price on measurement date, exercise price of the instrument, expected volatility (based on weighted average historic volatility), weighted average expected life of the instruments (based on historical experience and general option
holder behaviour unless no entity-specific information exists in which case the average of the vesting and contractual periods is used), expected dividends, and the risk-free interest rate (based on government bonds). Service and non-market
performance conditions attached to the transactions, if any, are not taken into account in determining fair value.
|
b)
|
Corporation equity incentive plan:
|
The Corporation established an equity
incentive plan for employees, directors and consultants. The plan provides for the issuance of restricted share units (RSU), performance share units, restricted shares, deferred share units and other share-based awards, subject to
restricted conditions as may be determined by the Board of Directors. There are no such awards outstanding as of March 31, 2017, February 28, 2017 and February 29, 2016 and no stock-based compensation was recognized for the one-month
and thirteen-month periods ended March 31, 2017 and $64 for the twelve-month period ended February 29, 2016 (2015 - $466).
F-31
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
Diluted loss per share was the same amount as basic loss
per share, as the effect of options, RSUs and warrants would have been anti-dilutive, because the Corporation incurred losses in each of the periods presented. All outstanding options, RSUs and warrants could potentially be dilutive in the future.
17.
|
Supplemental cash flow disclosure:
|
|
(a)
|
Changes in non-cash operating items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thirteen-months
ended
|
|
|
Month ended
|
|
|
Twelve-months
ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
March 31,
2017
|
|
|
March 31,
2017
(Unaudited)
|
|
|
February 28,
2017
(Unaudited)
|
|
|
February 29,
2016
|
|
|
February 28,
2015
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
Receivables
|
|
|
193
|
|
|
|
(40)
|
|
|
|
233
|
|
|
|
406
|
|
|
|
248
|
|
Receivable from corporation under common control
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50
|
|
|
|
47
|
|
Inventories
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88
|
|
|
|
174
|
|
Prepaid expenses
|
|
|
247
|
|
|
|
(33)
|
|
|
|
280
|
|
|
|
(138)
|
|
|
|
385
|
|
Trade and other payables
|
|
|
382
|
|
|
|
(252)
|
|
|
|
634
|
|
|
|
50
|
|
|
|
(87)
|
|
Receivable/payable to parent
corporation
|
|
|
(30)
|
|
|
|
(3)
|
|
|
|
(27)
|
|
|
|
(497)
|
|
|
|
539
|
|
|
|
|
792
|
|
|
|
(328)
|
|
|
|
1,120
|
|
|
|
(41)
|
|
|
|
1,306
|
|
(b) Non-cash transactions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thirteen-months
ended
|
|
|
Month ended
|
|
|
Twelve-months
ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
March 31,
2017
|
|
|
March 31,
2017
(Unaudited)
|
|
|
February 28,
2017
(Unaudited)
|
|
|
February 29,
2016
|
|
|
February 28,
2015
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
Equity settled share-based payment included in equity ($85) and unsecured convertible debentures
($9)
|
|
|
94
|
|
|
|
|
|
|
|
94
|
|
|
|
|
|
|
|
|
|
Issuance of broker warrants included in net proceeds from public offering
|
|
|
144
|
|
|
|
|
|
|
|
144
|
|
|
|
|
|
|
|
|
|
Public offering transaction costs included in trade and other payables
|
|
|
381
|
|
|
|
381
|
|
|
|
416
|
|
|
|
|
|
|
|
|
|
Reduction in share issue costs from reduction in trade and other payables
|
|
|
109
|
|
|
|
|
|
|
|
109
|
|
|
|
|
|
|
|
|
|
Private Placement transaction costs included in trade and other payables
|
|
|
40
|
|
|
|
40
|
|
|
|
50
|
|
|
|
|
|
|
|
|
|
Equipment included in trade and other payables
|
|
|
288
|
|
|
|
288
|
|
|
|
269
|
|
|
|
|
|
|
|
|
|
Interest payable included in trade and other payables
|
|
|
18
|
|
|
|
18
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
Issuance of shares on settlement of a liability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
103
|
|
|
|
|
|
Intangible assets included in trade and other payables
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8
|
|
Interest receivable included in payable to parent
corporation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27
|
|
|
|
|
|
F-32
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian
dollars, except where noted and for share and per share amounts)
Deferred tax (recovery) expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thirteen-months
ended
|
|
|
Month
ended
|
|
|
Twelve-months
ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
March 31,
2017
|
|
|
March 31,
2017
(Unaudited)
|
|
|
February 28, 2017
(Unaudited)
|
|
|
February 29,
2016
|
|
|
February 28,
2015
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
Origination and reversal of temporary differences
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,065
|
|
|
|
2,221
|
|
|
|
|
2,240
|
|
|
|
163
|
|
|
|
2,077
|
|
|
|
|
|
|
|
|
|
Change in unrecognized deductible temporary differences
|
|
|
(2,369)
|
|
|
|
|
|
|
|
(2,206)
|
|
|
|
(2,065)
|
|
|
|
(2,221)
|
|
|
|
|
|
|
|
|
(163)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax (recovery) expense
|
|
|
(129)
|
|
|
|
|
|
|
|
(129)
|
|
|
|
|
|
|
|
|
|
Reconciliation of effective tax rate:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thirteen-months
ended
|
|
|
Month
ended
|
|
|
Twelve-months
ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
March 31,
2017
|
|
|
March 31,
2017
(Unaudited)
|
|
|
February 28, 2017
(Unaudited)
|
|
|
February 29,
2016
|
|
|
February 28,
2015
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(11,376)
|
|
|
|
|
|
|
|
(10,607)
|
|
|
|
(6,317)
|
|
|
|
(1,654)
|
|
|
|
|
|
|
|
|
(769)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic combined Canadian statutory income tax
rate
1
|
|
|
26.87%
|
|
|
|
|
|
|
|
26.88%
|
|
|
|
26.90%
|
|
|
|
26.90%
|
|
|
|
|
|
|
|
|
26.80%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Computed income tax recovery
|
|
|
(3,057)
|
|
|
|
(207)
|
|
|
|
(2,850)
|
|
|
|
(1,699)
|
|
|
|
(445)
|
|
Increase resulting from:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrecognized deductible temporary differences
|
|
|
2,369
|
|
|
|
163
|
|
|
|
2,206
|
|
|
|
2,065
|
|
|
|
2,221
|
|
Non-deductible stock-based compensation
|
|
|
178
|
|
|
|
23
|
|
|
|
155
|
|
|
|
83
|
|
|
|
418
|
|
Non-deductible change in fair value
|
|
|
14
|
|
|
|
6
|
|
|
|
8
|
|
|
|
(592)
|
|
|
|
(2,374)
|
|
Permanent differences and other
|
|
|
166
|
|
|
|
12
|
|
|
|
154
|
|
|
|
143
|
|
|
|
180
|
|
Change in statutory income tax rate
|
|
|
201
|
|
|
|
3
|
|
|
|
198
|
|
|
|
|
|
|
|
|
|
Total tax (recovery) expense
|
|
|
(129)
|
|
|
|
|
|
|
|
(129)
|
|
|
|
|
|
|
|
|
|
1
The Canadian combined statutory income tax rate
has decreased due to a reduction in the provincial statutory income tax rate.
F-33
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian dollars, except where noted and for share and per share amounts)
18.
|
Income taxes (continued):
|
Unrecognized deferred tax assets:
At March 31, 2017, February 28, 2017 and February 29, 2016, the net deferred tax assets, which have not been
recognized in these financial statements because the criteria for recognition of these assets were not met, were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
|
February 28, 2017
|
|
|
February 29, 2016
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Deferred tax assets
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax losses carried forward
|
|
|
8,293
|
|
|
|
8,153
|
|
|
|
6,020
|
|
Research and development expenses
|
|
|
4,220
|
|
|
|
4,196
|
|
|
|
3,866
|
|
Property, plan and equipment and intangible assets
|
|
|
435
|
|
|
|
423
|
|
|
|
340
|
|
Other deductible temporary differences
|
|
|
522
|
|
|
|
539
|
|
|
|
388
|
|
Deferred tax assets
|
|
|
13,470
|
|
|
|
13,311
|
|
|
|
10,614
|
|
|
|
|
|
Deferred tax liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax basis of unsecured convertible
debentures in excess of carrying value
|
|
|
122
|
|
|
|
126
|
|
|
|
|
|
Deferred tax liabilities
|
|
|
122
|
|
|
|
126
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets
|
|
|
13,348
|
|
|
|
13,185
|
|
|
|
10,614
|
|
On initial recognition of the unsecured convertible debenture equity component, a deferred tax
liability of $129 was recognized with the corresponding entry recognized directly in Other equity. Consequently, an equal amount of deferred tax asset related to unrecognized tax losses was recognized with the offsetting entry in the Corporation
statement of earnings and comprehensive loss.
As at March 31, 2017 and February 28, 2017, the amounts and expiry
dates of tax attributes and temporary differences, which are available to reduce future years taxable income, were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
|
February 28, 2017
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
Federal
|
|
|
Provincial
|
|
|
Federal
|
|
|
Provincial
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
Tax losses carried forward
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2029
|
|
|
714
|
|
|
|
714
|
|
|
|
714
|
|
|
|
714
|
|
2030
|
|
|
1,627
|
|
|
|
1,620
|
|
|
|
1,627
|
|
|
|
1,620
|
|
2031
|
|
|
2,071
|
|
|
|
2,063
|
|
|
|
2,071
|
|
|
|
2,063
|
|
2032
|
|
|
2,262
|
|
|
|
2,241
|
|
|
|
2,262
|
|
|
|
2,241
|
|
2033
|
|
|
1,854
|
|
|
|
1,825
|
|
|
|
1,854
|
|
|
|
1,825
|
|
2034
|
|
|
3,597
|
|
|
|
3,597
|
|
|
|
3,597
|
|
|
|
3,597
|
|
2035
|
|
|
4,595
|
|
|
|
4,595
|
|
|
|
4,595
|
|
|
|
4,595
|
|
2036
|
|
|
5,494
|
|
|
|
5,494
|
|
|
|
5,494
|
|
|
|
5,494
|
|
2037
|
|
|
9,109
|
|
|
|
9,109
|
|
|
|
8,579
|
|
|
|
8,579
|
|
|
|
|
31,323
|
|
|
|
31,260
|
|
|
|
30,793
|
|
|
|
30,728
|
|
|
|
|
|
|
Research and development expenses, without
time limitation
|
|
|
15,436
|
|
|
|
16,559
|
|
|
|
15,347
|
|
|
|
16,469
|
|
|
|
|
|
|
Other deductible temporary differences,
without time limitation
|
|
|
3,154
|
|
|
|
3,154
|
|
|
|
3,158
|
|
|
|
3,158
|
|
F-34
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian dollars, except where noted and for share and per share amounts)
19.
|
Financial instruments:
|
This note provides disclosures relating to the
nature and extent of the Corporations exposure to risks arising from financial instruments, including credit risk, foreign currency risk, interest rate risk and liquidity risk, and how the Corporation manages those risks.
Credit risk is the risk of a loss if a customer or counterparty to
a financial asset fails to meet its contractual obligations. The Corporation has credit risk relating to cash and cash equivalents and short-term investments, which it manages by dealing only with highly-rated Canadian institutions. The carrying
amount of financial assets, as disclosed in the statements of financial position, represents the Corporations credit exposure at the reporting date.
The Corporation is exposed to the financial risk related to the
fluctuation of foreign exchange rates and the degrees of volatility of those rates. Foreign currency risk is limited to the portion of the Corporations business transactions denominated in currencies other than the Canadian dollar.
Fluctuations related to foreign exchange rates could cause unforeseen fluctuations in the Corporations operating results.
A portion of the expenses, mainly related to research contracts and purchase of production equipment, is incurred in US dollars
and in Euros, for which no financial hedging is required. There is a financial risk related to the fluctuation in the value of the US dollar and the Euro in relation to the Canadian dollar. In order to minimize the financial risk related to the
fluctuation in the value of the US dollar in relation to the Canadian dollar, funds continue to be invested as short-term investments in the US dollar.
The following table provides an indication of the Corporations significant foreign exchange currency exposures as stated
in Canadian dollars at the following dates:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
|
February 28, 2017
(Unaudited)
|
|
|
February 29,
2016
|
|
|
|
US$
|
|
|
Euro
|
|
|
US$
|
|
|
Euro
|
|
|
US$
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
3,524
|
|
|
|
|
|
|
|
3,691
|
|
|
|
|
|
|
|
2,872
|
|
Short-term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,442
|
|
Receivables
|
|
|
2
|
|
|
|
|
|
|
|
3
|
|
|
|
|
|
|
|
1
|
|
Trade and other payables
|
|
|
(503)
|
|
|
|
(317)
|
|
|
|
(376)
|
|
|
|
(603)
|
|
|
|
(275)
|
|
|
|
|
3,023
|
|
|
|
(317)
|
|
|
|
3,318
|
|
|
|
(603)
|
|
|
|
10,040
|
|
The following exchange rates are those applicable to the following periods and dates:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2017
|
|
|
|
|
|
February 28,
2017
|
|
|
|
|
|
February 29,
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Reporting
|
|
|
Average
|
|
|
Reporting
|
|
|
Average
|
|
|
Reporting
|
|
|
|
|
|
|
|
|
CA$ per US$
|
|
|
1.3134
|
|
|
|
1.3299
|
|
|
|
1.3113
|
|
|
|
1.3281
|
|
|
|
1.3071
|
|
|
|
1.3531
|
|
CA$ per Euro
|
|
|
1.4424
|
|
|
|
1.4251
|
|
|
|
1.4434
|
|
|
|
1.4066
|
|
|
|
1.4393
|
|
|
|
|
|
F-35
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian dollars, except where noted and for share and per share amounts)
19.
|
Financial instruments (continued):
|
|
(b)
|
Currency risk (continued):
|
Based on the Corporations foreign currency exposures noted above,
varying the above foreign exchange rates to reflect a 5% strengthening of the US dollar and Euro would have decrease in net loss as follows, assuming that all other variables remain constant:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
|
February 28, 2017
|
|
|
February 29, 2016
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
Decrease in net loss
|
|
|
139
|
|
|
|
151
|
|
|
|
502
|
|
An assumed 5% weakening of the foreign currencies would have an equal but opposite effect
on the basis that all other variables remained constant.
Interest rate risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of
changes in market rates.
The Corporations exposure to interest rate risk as at March 31,
2017, February 28, 2017 and February 29, 2016 is as follows:
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
Short-term fixed interest rate
|
|
Short-term investments
|
|
|
Short-term fixed interest rate
|
|
Unsecured convertible debentures
|
|
|
Long-term fixed interest rate
|
|
The capacity of the Corporation to reinvest the short-term amounts with equivalent return
will be impacted by variations in short-term fixed interest rates available on the market. Management believes that the risk the Corporation will realize a loss as a result of the decline in the fair value of its cash equivalents is limited because
these investments have short-term maturities and are generally held to maturity.
Liquidity risk is the risk that the Corporation will not be
able to meet its financial obligations as they fall due. The Corporation manages liquidity risk through the management of its capital structure and financial leverage, as outlined in Note 22. It also manages liquidity risk by continuously monitoring
actual and projected cash flows. The Board of Directors reviews and approves the Corporations operating budgets, and reviews material transactions outside the normal course of business. Refer to Note 2(c).
F-36
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian dollars, except where noted and for share and per share amounts)
19.
|
Financial instruments (continued):
|
|
(d)
|
Liquidity risk (continued):
|
The following are the contractual maturities of financial liabilities as at March 31, 2017, February 28, 2017 and
February 29, 2016:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
Required payments per year
|
|
Notes
|
|
Total
$
|
|
|
Carrying amount
$
|
|
|
Less than 1 year
$
|
|
|
1 to 3 years
$
|
|
|
|
|
|
|
|
Trade and other payables
|
|
9
|
|
|
2,126
|
|
|
|
2,126
|
|
|
|
2,126
|
|
|
|
|
|
Payable to parent corporation
|
|
5(c)
|
|
|
12
|
|
|
|
12
|
|
|
|
12
|
|
|
|
|
|
Unsecured convertible debentures
|
|
11
|
|
|
2,463
|
|
|
|
1,406
|
|
|
|
160
|
|
|
|
2,303
|
|
|
|
|
4,601
|
|
|
|
3,544
|
|
|
|
2,298
|
|
|
|
2,303
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
February 28, 2017
(Unaudited)
|
|
Required payments per year
|
|
|
|
Total
$
|
|
|
Carrying amount
$
|
|
|
Less than 1 year
$
|
|
|
1 to 3 years
$
|
|
|
|
|
|
|
|
Trade and other payables
|
|
9
|
|
|
2,390
|
|
|
|
2,390
|
|
|
|
2,390
|
|
|
|
|
|
Payable to parent corporation
|
|
5(c)
|
|
|
15
|
|
|
|
15
|
|
|
|
15
|
|
|
|
|
|
Unsecured convertible debentures
|
|
11
|
|
|
2,480
|
|
|
|
1,389
|
|
|
|
160
|
|
|
|
2,316
|
|
|
|
|
4,885
|
|
|
|
3,794
|
|
|
|
2,565
|
|
|
|
2,316
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
February 29, 2016
|
|
Required payments per year
|
|
|
|
Total
$
|
|
|
Carrying amount
$
|
|
|
Less than 1 year
$
|
|
|
1 to 3 years
$
|
|
|
|
|
|
|
|
Trade and other payables
|
|
9
|
|
|
1,126
|
|
|
|
1,126
|
|
|
|
1,126
|
|
|
|
|
|
Payable to parent corporation
|
|
5(c)
|
|
|
15
|
|
|
|
15
|
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
1,141
|
|
|
|
1,141
|
|
|
|
1,141
|
|
|
|
|
|
The Derivative warrant liabilities are excluded from the above tables as they will be
settled in shares and not by the use of liquidities.
F-37
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian dollars, except where noted and for share and per share amounts)
20.
|
Commitments and contingencies:
|
Research and development agreements:
In the normal course of business, the Corporation has signed agreements with various partners and suppliers for them to execute
research and development projects and to produce certain tools and equipment. The Corporation has reserved certain rights relating to these projects.
The Corporation initiated research and development projects that are planned to be conducted over the next 12-month period for a
total cost of $2,169 of which an amount of $785 has been paid to date. As at March 31, 2017, an amount of $467 is included in Trade and other payables in relation to these projects.
The Corporation has also entered into a contract to purchase production equipment for a total cost of $1,162 to be used in the
manufacturing of the clinical and future commercial supply of CaPre
®
, of which an amount of $853 has been paid to date. As at March 31, 2017, an amount of $288 is
included in Trade and other payables related to this equipment.
Contingencies:
A former CEO of the Corporation is claiming the payment of approximately $8.5 million and the issuance of equity instruments
from the Group. As the Corporations management believes that these claims are not valid, no provision has been recognized. Neptune and its subsidiaries also filed an additional claim to recover certain amounts from the former officer. All
outstanding share-based payments held by the former CEO have been cancelled during the year ended February 28, 2015.
The Corporation is also involved in other matters arising in the ordinary course of its business. Since management believes
that all related claims are not valid and it is presently not possible to determine the outcome of these matters, no provisions have been made in the financial statements for their ultimate resolution beyond the amounts incurred and recorded for
such matters. The resolution of such matters could have an effect on the Corporations financial statements in the year that a determination is made, however, in managements opinion, the final resolution of all such matters is not
projected to have a material adverse effect on the Corporations financial position.
21.
|
Determination of fair values:
|
Certain of the Corporations
accounting policies and disclosures require the determination of fair value, for both financial assets and liabilities. Fair values have been determined for measurement and/or disclosure purposes based on the following methods.
Financial assets and liabilities:
In establishing fair value, the Corporation uses a fair value hierarchy based on levels as defined below:
|
|
|
Level 1: defined as observable inputs such as quoted prices in active markets.
|
|
|
|
Level 2: defined as inputs other than quoted prices in active markets that are either directly or
indirectly observable.
|
|
|
|
Level 3: defined as inputs that are based on little or no observable market data, therefore
requiring entities to develop their own assumptions.
|
The Corporation has determined that the carrying
values of its short-term financial assets and liabilities approximate their fair value given the short-term nature of these instruments. The fair value of the liability component of the convertible debenture is determined by discounting future cash
flows using a rate that the Corporation could obtain for loans with similar terms, conditions and maturity dates. The fair value of this liability at February 28, 2017 and March 31, 2017 has not changed from the issuance date of
February 21, 2017 and was measured using level 3 inputs.
F-38
ACASTI PHARMA INC.
Notes to Financial Statements
Thirteen-month and one-month periods
ended March 31, 2017, twelve-month period ended February 28, 2017 and years ended February 29, 2016 and February 28, 2015
(thousands of Canadian dollars, except where noted and for share and per share amounts)
21.
|
Determination of fair values (continued):
|
Derivative warrant liabilities:
The Corporation measured its derivative warrant liabilities at fair value on a recurring basis. These financial liabilities were
measured using a level 3 inputs
(Note 10).
As at March 31, 2017, the effect of an increase or a decrease of 5%
of the volatility used, which is the significant unobservable input in the fair value estimate, would result in a loss of $49 or a gain of $44, respectively. As at February 28, 2017, the effect of an increase or a decrease of 5% of the
volatility used, which is the significant unobservable input in the fair value estimate, would result in a loss of $45 (unaudited) or a gain of $40 (unaudited), respectively.
Since inception, the Corporations objective in managing capital is to ensure sufficient liquidity to finance its research
and development activities, general and administrative expenses, expenses associated with intellectual property protection and its overall capital expenditures. The Corporation is not exposed to external requirements by regulatory agencies or third
parties regarding its capital, except for certain covenants included within the convertible debentures
(Note 11
).
Since the beginning of its operations, the Corporation has primarily financed its liquidity needs from funding provided through
public offerings, private placements, its parent corporation, from the exercise of warrants that were distributed to its parent corporations shareholders, from a rights offering and from the issuance of options to employees. However, the
Corporation attempts to optimize its liquidity needs with non-dilutive sources whenever possible, including from research and development tax credits or government assistance.
The Corporation defines capital to include total shareholders equity, derivative warrant liabilities and unsecured
convertible debentures.
The Corporations policy is to maintain a minimal level of debt.
The following table summarizes the cash and cash equivalents and short-term investments of the Corporation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
|
February 28, 2017
(Unaudited)
|
|
|
February 29, 2016
|
|
|
|
|
|
Cash
|
|
|
6,778
|
|
|
|
7,584
|
|
|
|
3,027
|
|
Cash equivalents
|
|
|
2,994
|
|
|
|
2,989
|
|
|
|
|
|
Short-term investments
|
|
|
|
|
|
|
|
|
|
|
7,443
|
|
|
|
|
9,772
|
|
|
|
10,573
|
|
|
|
10,470
|
|
As at March 31, 2017 and February 28, 2017, cash equivalents consisting of two
term deposits totaling $2,994 (US - $2,251) and $2,990 (US$2,251) (unaudited), respectively, are being held with a Canadian financial institution having a high credit rating. The term deposits as at March 31, 2017 have maturity dates of
April 11, 2017 and April 25, 2017, bearing an interest rate of 0.52% and 0.53% per annum, respectively, cashable at any time at the discretion of the Corporation, under certain conditions. The term deposits as at February 28,
2017 have maturity dates of March 12, 2017 and March 28, 2017, bearing an interest rate of 0.46% and 0.45% per annum, respectively, cashable at any time at the discretion of the Corporation, under certain conditions.
As at February 29, 2016, a short-term investment consisting of a term deposit totaling $7,443 (US - $5,500) was with a
Canadian financial institution having a high credit rating. The short-term investment had a maturity date of March 29, 2016, bearing an interest rate of 0.33% per annum, cashable at any time at the discretion of the Corporation, under
certain conditions.
F-39