UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_____________________________
FORM 20-F
_____________________________
☐
☒
☐
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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) or (g) OF THE SECURITIES EXCHANGE ACT OF 1934
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended March 31, 2019
OR
Commission file number: 001-35776
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Acasti Pharma Inc.
(Exact name of Registrant as specified in its charter)
_____________________________
N/A
(Translation of Registrant’s name into English)
Québec, Canada
(Jurisdiction of incorporation or organization)
545, Promenade du Centropolis, Suite 100, Laval, Québec H7T 0A3
(Address of principal executive office)
Jean-François Boily, Vice President, Finance, Acasti Pharma Inc.
545, Promenade du Centropolis, Suite 100 Laval, Québec H7T 0A3
Tel: 450-687-2262
Fax: 450-687-2272
(Name, Telephone, Email and/or Facsimile number and Address of Company Contact Person)
Title of each class
Common Shares, no par value
Securities registered or to be registered pursuant to Section 12(b) of the Act.
Trading symbol(s)
ACST
Name of each exchange on which registered
The NASDAQ Capital Market
Securities registered or to be registered pursuant to Section 12(g) of the Act.
Not applicable
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.
None
_____________________________
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.
78,132,734 Common Shares issued and outstanding as of March 31, 2019.
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 every Interactive Data File required to be submitted 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 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):
Large accelerated filer ☐
Emerging growth company ☐
Non-accelerated filer ☒
Accelerated filer ☐
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:
U.S. GAAP ☐
International Financial Reporting Standards as
issued by the International Accounting Standards Board ☒
Other ☐
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow. Item 17 ☐ Item 18 ☐
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
TABLE OF CONTENTS
INTRODUCTION AND USE OF CERTAIN TERMS
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
PART I
Item 1.
Item 2.
Item 3.
Item 4.
Item 4A.
Item 5.
Item 6.
Item 7.
Item 8.
Item 9.
Item 10.
Item 11.
Item 12.
Identity of Directors, Senior Management and Advisers
Offer Statistics and Expected Timetable
Key Information
Information on the Company
Unresolved Staff Comments
Operating and Financial Review and Prospects
Directors, Senior Management and Employees
Major Shareholders and Related Party Transactions
Financial Statements
The Offer and Listing
Additional Information
Quantitative and Qualitative Disclosure about Market Risk
Description of Securities other than Equity Securities
PART II
Item 13.
Item 14.
Item 15.
Item 16.
Item 16A.
Item 16B.
Item 16C.
Item 16D.
Item 16E.
Item 16F.
Item 16G.
Item 16H.
Defaults, Dividend Arrearages and Delinquencies
Material Modification to the Rights of Security Holdings and Use of Proceeds
Controls and Procedures
Reserved
Audit Committee Financial Expert
Code of Ethics
Principal Accountant Fees and Services
Exemptions from the Listing Standards for Audit Committees
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
Change in Registrant’s Certifying Accountant
Corporation Governance
Mining Safety Disclosure
PART III
Item 17.
Item 18.
Item 19.
EXHIBITS INDEX
SIGNATURES
Financial Statements
Financial Statements
Exhibits
1
1
5
5
5
5
23
46
46
60
72
73
73
73
84
84
86
86
86
86
86
86
86
87
87
87
87
88
88
88
88
88
88
89
91
INTRODUCTION AND USE OF CERTAIN TERMS
As used in this annual report on Form 20-F, or this annual report, unless the context otherwise requires, references to “we”, “our”, “us”, “Acasti”, “Acasti Pharma”,
“Corporation”, “it”, “its” or similar terms refer to Acasti Pharma Inc.
Market data and certain industry data and forecasts included in this annual report were obtained from internal company surveys, market research, and 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 management’s 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.
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® is our registered trademark. 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.
Financial Information
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, unless otherwise specified.
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, litigation settlement expected to be paid via
common shares, 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” 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.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This annual report contains information that may be forward-looking information within the meaning of Canadian securities laws and forward-looking statements within
the meaning of U.S. federal securities laws, both of which we refer to in this annual report as forward-looking information. Forward-looking information can be identified by the
use of terms such as “may”, “will”, “should”, “expect”, “plan”, “anticipate”, “believe”, “intend”, “estimate”, “predict”, “potential”, “continue” or other similar expressions
concerning matters that are not statements about the present or historical facts. Forward-looking information in this annual report includes, among other things, information or
statements about:
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our ability to conduct all required clinical and nonclinical trials for CaPre, including the timing and results of those trials;
our strategy, future operations, prospects and the plans of our management;
the design, regulatory plan, timeline, costs and results of our clinical and nonclinical trials for CaPre;
the timing and outcome of our meetings and discussions with the U.S. Food and Drug Administration, or FDA;
our planned regulatory filings for CaPre, and their timing;
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our expectation that our Bridging Study (as defined below) results will support our plan to get authorization from the FDA to use the 505(b)(2) pathway with new
chemical entity, or NCE, status towards a New Drug Application, or NDA, approval in the United States;
the timing and results from the STRENGTH study (conducted by Astra Zeneca with their omega-3 (OM3) drug EPANOVA) in patients with high triglycerides, or TGs
(blood levels between 200-499 mg/dL) and concomitantly taking a statin;
the potential benefits and risks of CaPre as compared to other products in the pharmaceutical, medical food and natural health products markets;
our estimates of the size of the potential market for CaPre, unmet medical needs in that market, the potential for market expansion, and the rate and degree of market
acceptance of CaPre if it reaches commercialization, and our ability to serve that market;
our anticipated marketing advantages and product differentiation of CaPre and its potential to become a best-in-class OM3 compound for the treatment of HTG;
the potential to expand CaPre’s indication for the treatment of high TGs (200-499 mg/dL);
the degree to which physicians would switch their patients to a product with CaPre’s target product profile;
our strategy and ability to develop, commercialize and distribute CaPre in the United States and elsewhere;
the manufacturing scale-up of CaPre beyond 20 tons per year and the related timing;
our ability to strengthen our patent portfolio and other means of protecting our intellectual property rights, including our ability to obtain additional patent protection for
CaPre;
our expectation that following expiration of the license agreement with Neptune Technologies & Bioressources Inc. (“Neptune”) we will not require any license from
third parties to support the commercialization of CaPre;
the availability, consistency and sources of our raw materials, including krill oil;
our expectation to be able to rely on third parties to manufacture CaPre whose manufacturing processes and facilities are in compliance with current good manufacturing
practices, or cGMP;
the potential for Omega-3 therapeutics, or OM3s in other cardiometabolic medicine indications;
our intention and ability to build a U.S. commercial organization and to successfully launch CaPre and compete in the U.S. market;
our intention and ability to complete development and/or distribution partnerships to support the commercialization of CaPre outside of the United States, and to pursue
strategic opportunities to provide capital and market access;
our need for additional financing and our estimates regarding our future financing and capital requirements;
our expectation regarding our financial performance, including our revenues, profitability, research and development, costs and expenses, gross margins, liquidity,
capital resources, and capital expenditures; and
our projected capital requirements to fund our anticipated expenses, including our research and development and general and administrative expenses, and capital
expenditures.
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 made by us when making forward-looking statements include, among
other things, assumptions by us that:
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we are able to obtain the additional capital and financing we require;
we successfully and timely complete all required clinical and nonclinical trials necessary for regulatory approval of CaPre;
the timeline and costs for our clinical and nonclinical programs are not materially underestimated or affected by unforeseen circumstances;
CaPre is safe and effective;
outcome study data from the STRENGTH study is positive;
we obtain and maintain regulatory approval for CaPre on a timely basis;
we are able to attract, hire and retain key management and skilled scientific and commercial personnel;
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third parties provide their services to us on a timely and effective basis;
we are able to maintain our required supply of raw materials, including krill oil;
we are able to find and retain a third-party to manufacture CaPre in compliance with cGMP;
we are able to successfully build a commercial organization, launch CaPre in the United States, and compete in the U.S. market;
we are able to secure distribution arrangements for CaPre outside of the United States, if it reaches commercialization;
we are able to manage our future growth effectively;
we are able to gain acceptance of CaPre in its markets and we are able to serve those markets;
our patent portfolio is sufficient and valid;
we are able to secure and defend our intellectual property rights and to avoid infringing upon the intellectual property rights of third parties;
we are able to take advantage of business opportunities in the pharmaceutical industry and receive strategic partner support;
we are able to continue as a going concern;
there is no significant increase in competition for CaPre from other companies in the pharmaceutical, medical food and natural health product industries;
CaPre would be viewed favorably by payers at launch and receive appropriate healthcare reimbursement;
· market data and reports reviewed by us are accurate;
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there are no adverse changes in relevant laws or regulations; and
we face no product liability lawsuits and other proceedings or any such matters, if they arise, are satisfactorily resolved.
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:
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risks related to timing and possible difficulties, delays or failures in our ongoing TRILOGY Phase 3 program for CaPre;
nonclinical and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that
warrant future development of CaPre;
CaPre may not prove to be as safe and effective or as potent as we currently believe;
our planned TRILOGY Phase 3 program may not produce positive results;
our anticipated studies and submissions to the FDA may not occur as currently anticipated, or at all;
the FDA could reject our 505(b)(2) regulatory pathway;
while the REDUCE-IT results (a Cardiovascular outcome study conducted by Amarin with their OM3 drug VASCEPA) were positive, the cardiovascular outcome study
data from the STRENGTH study could be negative, which could also negatively affect the market perception of CaPre;
we may encounter difficulties, delays or failures in obtaining regulatory approvals for the initiation of clinical trials or to market CaPre, or the FDA may refuse to
approve CaPre, or place restrictions on our ability to commercialize CaPre;
we may need to conduct additional future clinical trials for CaPre, the occurrence and success of which cannot be assured;
CaPre may have unknown side effects;
CaPre could be subject to extensive post-market obligations and continued regulatory review, which may result in significant additional expense and affect sales,
marketing and profitability;
we may fail to achieve our publicly announced milestones on time;
we may encounter difficulties in completing the development and commercialization of CaPre;
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third parties we will rely upon to conduct our TRILOGY Phase 3 program for CaPre may not effectively fulfill their obligations to us, including complying with FDA
requirements;
there may be difficulties, delays, or failures in obtaining health care reimbursements for CaPre;
recently enacted and future laws may increase the difficulty and cost for us to obtain marketing approval of and commercialize CaPre and affect the prices we can
charge;
new laws, regulatory requirements, and the continuing efforts of governmental and third-party payors to contain or reduce the costs of healthcare through various means
could adversely affect our business;
the market opportunity for, and demand and market acceptance of, CaPre may not be as strong as we anticipate;
third parties that we will rely upon to manufacture, supply and distribute CaPre may not effectively fulfill their obligations to us, including complying with FDA
requirements;
there may not be an adequate supply of raw materials, including krill oil, in sufficient quantities and quality and to produce CaPre under cGMP standards;
we may not be able to meet applicable regulatory standards for the manufacture of CaPre or scale-up our manufacturing successfully;
as a development stage company, we have limited sales, marketing and distribution personnel and resources;
our patent applications may not result in issued patents, our issued patents may be circumvented or challenged and ultimately struck down, and we may not be able to
successfully protect our trade secrets or other confidential proprietary information;
we may face claims of infringement of third party intellectual property and other proprietary rights;
we may face product liability claims and product recalls;
we may face intense competition from other companies in the pharmaceutical, medical food and natural health product industries;
we have a history of negative operating cash flow and may never become profitable or be able to sustain profitability;
we have significant additional future capital needs and may not be able to raise additional financing required to fund further research and development, clinical studies,
obtain regulatory approvals, build a commercial organization in the United States, and meet ongoing capital requirements to continue our current operations on
commercially acceptable terms or at all;
we may not be able to successfully compete in the U.S. market with competitors who are larger and have more resources than we do;
we may acquire businesses or products or form strategic partnerships in the future that may not be successful;
we may be unable to secure development and/or distribution partnerships to support the development and commercialization of CaPre outside the United States, provide
development capital, or market access;
we rely on the retention of key management and skilled scientific, manufacturing, regulatory and commercial personnel; and
general changes in economic and capital market conditions could adversely affect us.
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.
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PART I
Item 1.
Identity of Directors, Senior Management and Advisers
Not applicable.
Item 2.
Offer Statistics and Expected Timetable
Not applicable.
Item 3.
Key Information
A.
Selected Financial Data
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 years ended March 31, 2019 and 2018 and the thirteen-month period 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 financial
information in accordance with IFRS as issued by the IASB for each of our five most recently completed fiscal years.
For the fiscal year ended
March 31, 2018 March 31, 2017(1) February 29, 2016 February 28, 2015
March 31, 2019
nil
nil $
nil
$
$
(12,395)
(11,210) $
(45,015) $
$
(1,655)
(11,247) $
(51,566) $
$
(0.16)
(1.01) $
(0.95) $
$
37,208
25,456 $
$
$
3,980
3,753 $
$
$
61,628
66,576 $
$
$
-
453 $
$
$
10,617,704
11, 094,512
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-
nil $
(19,696) $
(21,504) $
(1.23) $
22,959 $
14,735 $
73,338 $
715 $
17,486,515
-
nil $
(9,612) $
(6,317) $
(0.59) $
28,517 $
1,297 $
61,973 $
- $
10,659,936
-
48,471
34,509
129,318
998
54,290,295
-
Revenue from sales
Loss from operating activities
Net loss and total comprehensive loss
Basic and diluted loss per share
Total assets
Total liabilities
Share capital
Equity - Classified Warrants and rights
Weighted average number of shares outstanding
Dividends declared per share
Note:
(1) For the thirteen-month period ended March 31, 2017.
B.
Capitalization and Indebtedness
Not applicable.
C.
Reasons for the Offer and Use of Proceeds
Not applicable.
D. Risk Factors
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 deem immaterial, may also negatively affect our business operations.”
General Risks Related to the Corporation
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 and research grant programs. Our cash and cash
equivalents (including restricted investments) were $ 34.4 million as of March 31, 2019 and $8.2 million as of March 31, 2018.
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Our current assets, as of March 31, 2019, are projected to support our current liabilities as at that date when combined with the projected level of our expenses for the next
twelve months, including fully funding the completion of our Phase 3 program for CaPre. 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, to further scale up our manufacturing capabilities, and to complete marketing and other pre-commercialization activities.
Consequently, we expect to require additional capital to fund our daily operating needs beyond the next twelve months. Based on a conservative estimate, we believe that our
existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements beyond the completion of our Phase 3 trials. To fully
execute our business plan, we plan to raise the necessary capital primarily through additional securities offerings and multiple sources of non-dilutive capital such as grants or
loans and strategic alliances. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay the commercial
launch of CaPre. Unexpected negative results in our TRILOGY Phase 3 program for CaPre may affect our ability to raise additional capital and/or complete strategic
development and/or distribution partnerships to support the commercial launch of CaPre. Additional funding from third parties may not be available on acceptable terms or at
all to enable us to continue with the commercialization of CaPre.
If we do not raise additional funds, we 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. 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 write-downs 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 the 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 for and begin selling CaPre in
significant quantities. We filed our investigational new drug application, or IND, for CaPre in late 2013, which allowed us to initiate clinical development in the United States
towards FDA approval for CaPre. 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 if we are able to commercialize CaPre, we may still not generate significant revenues or achieve profitability. Additionally, we may not be able to attain our
targeted cost of goods sold, and levels of insurance reimbursement for CaPre may not be commercially viable in all global markets. We incurred net losses for the fiscal year
ended March 31, 2019 of $ 51.6 million, $21.5 million for the year ended March 31, 2018 and $11.2 million for the thirteen-month period ended March 31, 2017, respectively.
As of March 31, 2019, we had an accumulated deficit of $ 123.9 million.
We expect that our expenses will increase in the future as we prepare to seek FDA approval for the commercial launch of CaPre. However, our research and development
expenses could increase in the future if we decide to develop CaPre for other indications. As a result, we expect to continue to incur substantial 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.
If outcome studies being conducted by our competitors testing the impact of OM3 on treating patients with high TGs are negative, there could also be an adverse impact for
CaPre.
Top-line results from the cardiovascular outcome trial (CVOT) sponsored by Amarin (the REDUCE-IT trial) were recently released. A second CVOT sponsored by
AstraZeneca (the STRENGTH trial) is expected to be reported in 2020. While the REDUCE-IT trial provided positive top line results, there can be no assurance that further
detailed or subsequent results will be positive. If those studies show or continue to show that OM3 therapeutic drugs effectively treat patients with high TGs and improve
cardiovascular, morbidity and mortality outcomes, we believe that the potential to expand CaPre’s indication in the future to include the treatment of high TGs would be
significantly advanced. Conversely, if outcome study data from Astra Zeneca’s STRENGTH trial is negative, or if it fails to be completed, our potential target market for CaPre
could be limited to patients with severe HTG (for which the total U.S. market was estimated based on audited prescription data by Symphony Health Analytics to be
approximately $1.4 billion in 2018) and our ability to realize greater market potential of CaPre could be harmed.
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We rely on third parties to conduct our TRILOGY Phase 3 program for CaPre.
We rely on contract research organizations, or CROs, to monitor and manage data for our TRILOGY Phase 3 program for CaPre. While we will only control certain
aspects of the CRO’s activities, we nevertheless are responsible for ensuring that our clinical trials are conducted in accordance with applicable protocols, and 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 current good clinical
practices, or cGCPs, which are regulations and guidelines enforced by the FDA, Health Canada and comparable foreign regulatory authorities for any products in clinical
development.
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 current good manufacturing practice, or 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 that are conducting our TRILOGY Phase 3 program for CaPre 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. Currently, while we do own our manufacturing and encapsulation equipment, we outsource the production of CaPre, and do not own or operate the manufacturing
facilities. Accordingly, we need to rely on one or more third party contract 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 scale up our manufacturing processes for CaPre, doing so is a difficult
and uncertain task, and there are risks associated with scaling to the level required for full commercialization, including, among others, pricing, cost overruns, potential
problems with process scale up, process reproducibility, stability issues, lot consistency and timely availability of reagents or raw materials. Consequently, we may not be able
to attain our targeted cost of goods sold for CaPre. Any of these challenges could delay the commercial launch of 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 cGMP regulations;
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
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.
If our third-party contract 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
contract manufacturers who could manufacture CaPre, we may incur added costs and delays in identifying and qualifying any such replacement.
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We have historically had no marketing and sales organization and, as a company, have no experience in marketing products. If we are unable to properly 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 historically had no sales, marketing or distribution capabilities and, as a company, we have also historically had 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,
medical, and commercial personnel. Competition for skilled personnel in our market is intense and competition may limit our ability to hire and retain highly qualified personnel
on acceptable terms. We are highly dependent on our management, financial, commercial, and scientific personnel. Despite our efforts to retain valuable employees, members
of our management, financial, commercial, 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.
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 complete the TRILOGY Phase 3 program 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.
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We may not be able to obtain required regulatory approvals for CaPre.
We have limited experience in obtaining 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;
we may not be able to provide acceptable evidence of the safety and efficacy of CaPre;
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;
the dosing of CaPre in a particular clinical trial may not be at an optimal level;
patients in our clinical trials may suffer adverse effects for reasons that may or may not be related to CaPre;
we may be unable to demonstrate that CaPre’s clinical and other benefits outweigh its safety risks;
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;
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
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(s) 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 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 are currently engaged in strategic partnership discussions with several pharmaceutical companies for the development and commercialization of 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 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.
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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 the 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 in earlier stages of developing products that, if
approved and marketed, could compete with CaPre.
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. Lower potency and lower purity forms of 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 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 CaPre
is not broadly covered by insurance, or the patient co-pay 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.
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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 FDA’s 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 FDA’s 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. Furthermore, for market approval in EU
countries, a CVOT outcome trial is currently required. These types of trials are large and follow patients for at least 5 years. There can be no guarantee that we will ever conduct
an outcome trial to meet these requirements to market in the EU.
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.
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 company’s 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. The
Healthcare Reform Law also includes significant provisions that encourage state and federal law enforcement agencies to increase activities related to preventing, detecting and
prosecuting those who commit fraud, waste and abuse in federal healthcare programs, including Medicare, Medicaid and Tricare.
Despite initiatives to invalidate the Health Care Reform Law, the U.S. Supreme Court has upheld key aspects of it. There is still uncertainty with respect to the impact the
current U.S. presidential administration and the U.S. Congress may have, if any, and the effects of any changes will likely take time to unfold. As judicial challenges and
legislative initiatives to modify, limit, or repeal the Healthcare Reform Law continue to evolve, 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;
existing patented drug prices cannot increase by more than the Canadian Consumer Price Index; and
the Canadian prices of patented medicines can never be the highest in the world.
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.
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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.
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 CaPre’s
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 FDA’s 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.
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Additional laws and regulations include:
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the federal Anti-Inducement Law (also known as the Civil Monetary Penalties Law), which prohibits a person from offering or transferring remuneration to a
Medicare or State healthcare program beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider,
practitioner or supplier of any item or service for which payment may be made, in whole or in part, by Medicare or a State healthcare program;
the Ethics in Patient Referrals Act of 1989, commonly referred to as the Stark Law, which prohibits physicians from referring Medicare or Medicaid patients for
certain designated health services where that physician or family member has a financial relationship with the entity providing the designated health service, unless
an exception applies;
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;
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 Children’s 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;
federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare
items or services reimbursed by non-governmental third-party payors, including private insurers, and some state laws require pharmaceutical companies report or
disclose pricing or other financial information and to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance
guidance promulgated by the federal government; and
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.
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 manufacturer’s 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 management’s 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;
warning letters;
voluntary or mandatory product recalls or public notification or medical product safety alerts to healthcare professionals;
restrictions on, or prohibitions against, marketing our products;
restrictions on, or prohibitions against, importation or exportation of our products;
suspension of review or refusal to approve pending applications or supplements to approved applications;
exclusion from participation in government-funded healthcare programs;
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exclusion from eligibility for the award of government contracts for our products;
suspension or withdrawal of product approvals;
product seizures;
injunctions; and
civil and criminal penalties and fines.
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 CRO’s 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.
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.
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 materials such as acetone. 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 potentially
hazardous 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.
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If product liability lawsuits are brought against us, we may incur substantial liabilities and may 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 may 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;
injury to our reputation;
costs to defend the related litigation;
a diversion of management’s time and our resources;
substantial monetary awards to consumers, trial participants or patients;
product recalls, withdrawals or labeling, marketing or promotional restrictions;
loss of revenue;
an inability to commercialize CaPre; and
a decline in the price of our common shares.
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, 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 complete our ongoing 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.
We may be subject to foreign exchange rate fluctuations.
Our reporting currency is the Canadian dollar. However, many of our expenses, such as CaPre’s chief manufacturing organization’s production activities and certain CRO
arrangements for our ongoing TRILOGY Phase 3 program, currently are and/or are expected to be, denominated in foreign currencies, including European euros and U.S.
dollars. As we currently complete financings in both Canadian and U.S. dollars, both currencies are maintained and used to make required payments in the applicable currency.
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.
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In the past, Neptune supplied us with the krill oil needed to produce CaPre for our clinical programs, including the krill oil needed for our TRILOGY Phase 3 program,
and we are now evaluating alternative suppliers for commercial supply.
We sourced all of our krill oil from Neptune in the past to produce CaPre. We have sufficient krill oil inventories that we anticipate will be required to complete our
TRILOGY Phase 3 program. However, in light of Neptune’s sale of its krill oil business and inventory to Aker in August 2017, we have been validating several alternative
suppliers of krill oil. While we believe that these alternative supplies of krill oil can meet our specifications and will be readily available, we do not have enough experience
with any one of them to guarantee that these alternative supplies of krill oil will be of comparable quality as compared to the krill oil provided by Neptune, which could
negatively affect the cost of CaPre. Our reliance on 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.
CaPre may cause or be perceived to cause undesirable side effects or have other properties that could delay or prevent its regulatory approval, limit the commercial profile
of an approved label, or result in significant negative consequences following marketing approval, if any.
Many of the patients that we expect to enroll in our ongoing Phase 3 clinical trial may have pre-existing disorders. While such disorders may lead to serious adverse events
during the clinical trial that may be found to be unrelated to CaPre, such events may create a negative safety perception and adversely impact market acceptance of CaPre
following any approval.
If unacceptable side effects arise during the clinical trials for CaPre, we, the FDA or comparable foreign regulatory authorities, the Institutional Review Boards, or IRBs, or
independent ethics committees at the institutions in which our studies are conducted, could suspend or terminate our clinical trials or the FDA or comparable foreign regulatory
authorities could order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications. Side effects, whether treatment-related or not,
could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. In addition, these side effects may not
be appropriately recognized or managed by the treating medical staff. Inadequate training in recognizing or managing the potential side effects of CaPre could result in patient
injury. Any of these occurrences may harm our business, financial condition and prospects significantly.
Moreover, clinical trials of CaPre are conducted in carefully defined sets of patients who have agreed to enter into clinical trials. Consequently, it is possible that our
clinical trials, or those of any future collaborator or third party researcher, may indicate an apparent positive effect of CaPre that is greater than the actual positive effect, if any,
or alternatively fail to identify undesirable side effects. If, following approval of a product candidate, we, or others, discover that the product is less effective than previously
believed or causes undesirable side effects that were not previously identified during the clinical trial phase, any of the following adverse events could occur:
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regulatory authorities may withdraw their approval of the product or seize the product;
we, or any future collaborators or third party researcher, may need to recall the product, or be required to change the way the product is administered or conduct
additional clinical trials;
restrictions may be imposed on the marketing of, or the manufacturing processes for CaPre;
we may be subject to fines, injunctions or the imposition of civil or criminal penalties;
regulatory authorities may require the addition of labeling statements;
we, or any future collaborators, may be required to issue a communication outlining the risks of the previously unidentified side effects for distribution to patients;
we, or any future collaborators, could be sued and held liable for harm caused to patients;
CaPre may become less competitive; and
our reputation may suffer.
Any of these events could harm our business and operations and could negatively impact our share price.
Risks Related to Intellectual Property
In addition to our own patents, CaPre is covered by patents that are sublicensed to us by Neptune and Aker.
In addition to our proprietary patent applications, pursuant to a license agreement we entered into with Neptune in August 2008, which was later amended on February 9,
2009 and March 7, 2013 (the “License Agreement”), we have a license to use certain intellectual property developed by Neptune and now owned by Aker to develop and
commercialize CaPre, and our novel and active pharmaceutical ingredients, or APIs, for use in pharmaceutical and medical food applications in the cardiovascular field.
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Moreover, the intellectual property which was licensed to us has recently been acquired by Aker. Aker has granted to Neptune the right to sublicense to us certain
intellectual property as necessary to allow us to maintain its license grant under the License Agreement. Accordingly, the license granted to us under the License Agreement
remains in full force.
Disputes may arise between us and Neptune or Aker 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; and
our right to sublicense patent and other rights to third parties under collaborative development relationships.
If our sublicense with Neptune is terminated due to a breach by us of its terms (or should the License Agreement otherwise terminate) and we are unable to enter into a
direct license agreement with Aker, we may not be able to manufacture and market CaPre prior to the expiration of the licensed patents in 2022. Any such occurrence could
delay our launch by 6 to 12 months, which would have a material adverse effect on our business and financial condition.
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;
successfully defend our patents, including enforcing licensed patents through the licensor Neptune/Aker, against third-party challenges; and
successfully enforce our patents against third party competitors.
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;
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;
our pending or future patent applications may not be issued with the breadth of claim coverage sought by us, or be issued at all;
our competitors could independently develop or patent technologies that are substantially equivalent or superior to our technologies;
our trade secrets could be learned independently by our competitors;
the steps we take to protect our intellectual property may not be adequate; and
effective patent, trademark, copyright and trade secret protection may be unavailable, limited or not sought by us in some foreign countries.
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.
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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;
divert the time and attention of our technical personnel and management;
delay our clinical trials for CaPre;
prevent us from commercializing CaPre until the asserted patent expires or is held finally invalid or not infringed in court;
require us to cease or to modify our use of the technology and/or develop non-infringing technology; or
require us to enter into royalty or licensing agreements.
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.
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
management’s 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 party’s patent’s 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 registered CaPre as a trademark in several jurisdictions. 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 licensor’s patent is invalid or unenforceable. In patent litigation, 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
patent office, such as 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.
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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.
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 Canada and 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 various patent offices around the world may have a significant impact on our ability
to protect our technology and enforce our intellectual property rights. These changes may lead to increasing uncertainty with regard to the scope and value of our issued patents
and to our ability to obtain patents in the future.
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 authorities in various 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 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.
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Risks Relating to Our Common Shares
The price of our common shares may be volatile.
Market prices for securities in general, and specifically that of pharmaceutical companies in particular, tend to fluctuate. Factors such as the announcement to the public or
in various scientific or industry forums of technological innovations; new commercial products; patents or exclusive rights obtained by us or others; disputes or other
developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies; the commencement, enrollment
or results of future clinical trials we may conduct, or changes in the development status of our product candidates; results or delays of pre-clinical and clinical studies by us or
others; any delay in our regulatory filings for our product candidates and any adverse development or perceived adverse development with respect to the applicable regulatory
authority’s review of such filings; a change of regulations; additions or departures of key scientific or management personnel; overall performance of the equity markets;
general political and economic conditions; publications; failure to meet the estimates and projections of the investment community or that we may otherwise provide to the
public; research reports or positive or negative recommendations or withdrawal of research coverage by securities analysts; actual or anticipated variations in quarterly operating
results; announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors; public concerns over the risks of
pharmaceutical products and dietary supplements; unanticipated serious safety concerns related to the use of CaPre; the ability to finance, future sales of securities by us or our
shareholders; and many other factors, many of which are beyond our control, could have considerable effects on the price of our securities. There can be no assurance that the
market price of our common shares will not experience significant fluctuations in the future. As a result of any of these factors, the market price of our securities at any given
point in time may not accurately reflect our value or the value of our securities.
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 in the
market price of these securities. This type of litigation, if instituted, could result in substantial costs and a diversion of management’s attention and resources, which would harm
our business, operating results or financial condition.
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 shareholders. The incurrence of indebtedness by us 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 alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates, or grant licenses
on terms unfavorable to us.
The market price of our common shares could decline as a result of operating results falling below the expectations of investors or fluctuations in operating results each
quarter.
Our net losses and expenses may fluctuate significantly and any failure to meet financial expectations may disappoint securities analysts or investors and result in a decline
in the price of our common shares. Our net losses and expenses have fluctuated in the past and are likely to do so in the future. These fluctuations could cause the market price
of our common shares to decline. Some of the factors that could cause the Corporation’s net losses and expenses to fluctuate include the following:
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results of preclinical studies and clinical trials, or the addition or termination of preclinical studies, clinical trials or funding support;
the fluctuations in valuation of our derivative warrant liabilities;
the timing of the release of results from any preclinical studies and clinical trials;
the inability to complete product development in a timely manner that results in a failure or delay in receiving the required regulatory approvals or allowances to
commercialize product candidates;
the timing of regulatory submissions and approvals;
the timing and willingness of any current or future collaborators to invest the resources necessary to commercialize our products;
the outcome of any litigation;
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changes in foreign currency fluctuations;
competition;
the timing of achievement and the receipt of milestone payments from current or future third parties;
failure to enter into new or the expiration or termination of current agreements with third parties;
failure to introduce our products to the market in a manner that generates anticipated revenues;
execution of any new collaboration, licensing or similar arrangement, and the timing of payments we may make or receive under such existing or future arrangements or
the termination or modification of any such existing or future arrangements;
any intellectual property infringement lawsuit or opposition, interference or cancellation proceeding in which we may become involved;
additions and departures of key personnel;
strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy;
if any of our product candidates receives regulatory approval, market acceptance and demand for such product candidates;
regulatory developments affecting our product candidates or those of our competitors; and
changes in general market and economic conditions.
If our quarterly operating results fall below the expectations of investors or securities analysts, the market price of our common shares could decline substantially. Furthermore,
any quarterly fluctuations in our operating results may, in turn, cause the market price of the common shares to fluctuate substantially. We believe that quarterly comparisons of
our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance.
There can be no assurance that an active market for our common shares will be sustained.
There can be no assurance that an active market for our common shares will be sustained. Holders of common shares may be unable to sell their investments on
satisfactory terms. As a result of any risk factor discussed herein, the market price of our common shares at any given point in time may not accurately reflect our long-term
value. Furthermore, responding to these risk factors could result in substantial costs and divert management’s attention and resources. Substantial and potentially permanent
declines in the value of our common shares may result and adversely affect the liquidity of the market for our common shares.
Other factors unrelated to our performance that may have an effect on the price and liquidity of our common shares include: extent of analyst coverage; lessening in
trading volume and general market interest in our common shares; the size of our public float; and any event resulting in a delisting of our common shares.
A large number of common shares may be issued and subsequently sold upon the exercise of existing warrants. The sale or availability for sale of existing warrants or
other securities convertible into common shares may depress the price of our common shares.
To the extent that existing holders of warrants sell common shares issued upon the exercise of warrants, the market price of our common shares may decrease due to the
additional selling pressure in the market. The risk of dilution from issuances of common shares underlying existing warrants may cause shareholders to sell their common
shares, which could further contribute to any decline in our common share market price.
Any downward pressure on the price of our common shares caused by the sale of common shares issued upon the exercise of existing warrants 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 seller profits
when the common share price declines because it is purchasing common shares at a price lower than the sale price of the borrowed common shares. Such short sales of common
shares could place downward pressure on the price of our common shares by increasing the number of common shares being sold, which could lead to a decline in the market
price of our common shares.
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We do not currently intend to pay any cash dividends on our common shares in the foreseeable future.
We have never paid any cash dividends on our common shares and we do not anticipate paying any cash dividends on our common shares in the foreseeable future
because, among other reasons, we currently intend to retain any future earnings to finance our business. The future payment of cash dividends will be dependent on factors such
as cash on hand and achieving profitability, the financial requirements to fund growth, our general financial condition and other factors our board of directors may consider
appropriate in the circumstances. Until we pay cash dividends, which we may never do, our shareholders will not be able to receive a return on their common shares unless they
sell them. See “Dividend Policy”.
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 shares are 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.
On May 16, 2019, we received written notification from the NASDAQ Listing Qualifications Department for failing to maintain a minimum bid price of U.S.$1.00 per
share for the last 30 consecutive business days, as required by NASDAQ Listing Rule 5550(a)(2) – bid price (the “Minimum Bid Price Rule”). The NASDAQ notification has
no immediate effect on the listing of our common shares. Under NASDAQ Listing Rule 5810(c)(3)(A) – compliance period, we have 180 calendar days, or until November 12,
2019, to regain compliance. If at any time over this period the bid price of our common shares closes at U.S.$1.00 per share or more for a minimum of ten (10) consecutive
business days, NASDAQ will provide written confirmation of compliance and the matter will be closed. If we do not regain compliance within the initial 180-day period, but
otherwise meet the continued listing requirements for market value of publicly-held shares and all other initial listing standards for the NASDAQ Listing Rule 5505 – Capital
Market criteria, except for the Minimum Bid Price Rule, we may be eligible for an additional 180 calendar days to regain compliance. If we are not granted additional time, then
our common shares will be subject to delisting, at which time we may appeal the delisting determination to a NASDAQ Hearings Panel.
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;
reduced liquidity for our common shares;
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;
a limited amount of news about us and analyst coverage of us; and
a decreased ability for us to issue additional equity securities or obtain additional equity or debt financing in the future.
We may pursue opportunities or transactions that adversely affect our business and financial condition.
Our management, in the ordinary course of our business, regularly explores potential strategic opportunities and transactions. These opportunities and transactions may
include strategic joint venture relationships, significant debt or equity investments in us by third parties, the acquisition or disposition of material assets, the licensing,
acquisition or disposition of material intellectual property, the development of new product lines or new applications for our existing products, significant distribution
arrangements, the sale of our common shares and other similar opportunities and transactions. The public announcement of any of these or similar strategic opportunities or
transactions might have a significant effect on the price of our common shares. Our policy is to not publicly disclose the pursuit of a potential strategic opportunity or
transaction unless we are required to do so by applicable law, including applicable securities laws relating to continuous disclosure obligations. There can be no assurance that
investors who buy or sell securities are doing so at a time when we are not pursuing a particular strategic opportunity or transaction that, when announced, would have a
significant effect on the price of our common shares.
In addition, any such future corporate development may be accompanied by certain risks, including exposure to unknown liabilities of the strategic opportunities and
transactions, higher than anticipated transaction costs and expenses, the difficulty and expense of integrating operations and personnel of any acquired companies, disruption of
our ongoing business, diversion of management’s time and attention, and possible dilution to shareholders. We may not be able to successfully overcome these risks and other
problems associated with any future acquisitions and this may adversely affect our business and financial condition.
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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, as amended (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.
We cannot be certain that we will qualify as a foreign private issuer for our next fiscal year. If we no longer qualify as a foreign private issuer, we will no longer be exempt
from the more stringent disclosure requirements applicable to U.S. companies.
As a non-accelerated filer, we are not required to comply with the auditor attestation requirements of the Sarbanes-Oxley Act.
We are a non-accelerated filer under the Exchange Act and not required to comply with 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 subject to the auditor attestation requirements. In addition, we cannot predict if investors will find our common shares less attractive because we are
not required to comply with the auditor attestation requirements. 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.
There is a significant risk that we may be classified as a PFIC for U.S. federal income tax purposes.
Current or potential investors in our common shares who are U.S. holders should be aware that, based on our most recent financial statements and projections and given
uncertainty regarding the composition of our future income and assets, there is a significant risk that we may have been classified as a “passive foreign investment company” or
“PFIC” for the 2019 taxable year and may be classified as a PFIC for our current taxable year and possibly subsequent years. If we are a PFIC for any year during a U.S.
holder’s holding period of our common shares, then such U.S. taxpayer generally will be required to treat any gain realized upon a disposition of such common shares or any
so-called “excess distribution” received on such common shares, as ordinary income (with a portion subject to tax at the highest rate in effect), and to pay an interest charge on a
portion of such gain or excess distribution. In certain circumstances, the sum of the tax and the interest charge may exceed the total amount of proceeds realized on the
disposition, or the amount of excess distribution received, by the U.S. holder. Subject to certain limitations, a timely and effective QEF Election under Section 1295 of the U.S.
Internal Revenue Code of 1986, as amended, or the Code, or a Mark-to-Market election under Section 1296 of the Code may be made with respect to the common shares. A
U.S. holder who makes a timely and effective QEF Election generally must report on a current basis its share of our net capital gain and ordinary earnings for any year in which
we are a PFIC, whether or not we distribute any amounts to our shareholders. A U.S. holder who makes the Mark-to-Market Election generally must include as ordinary income
each year the excess of the fair market value of their common shares over the holder’s basis therein. This paragraph is qualified in its entirety by the discussion under the
heading “Item 10.E. Taxation—U.S. Federal Income Tax Considerations of the Acquisition, Ownership, and Disposition of Common Shares—Passive Foreign Investment
Company Rules”. Each current or potential investor who is a 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 of the acquisition, ownership, and disposition of our common shares, the U.S. federal tax consequences of the PFIC rules, and 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.
Item 4.
Information on the Company
A.
History and Development of the Company
Acasti was 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) (“QBCA”) came into effect and replaced the Companies Act (Québec). We are now governed by the QBCA. On August 7, 2008, pursuant to a
Certificate of Amendment, we changed our name to “Acasti Pharma Inc.”, our share capital description, the provisions regarding the restriction on securities transfers and our
borrowing powers. On November 7, 2008, pursuant to a Certificate of Amendment, we changed the provisions regarding our borrowing powers. We became a reporting issuer
in the Province of Québec on November 17, 2008.
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Acasti’s head and registered office is located at 545 Promenade du Centropolis, Suite 100, Laval, Québec H7T 0A3. We currently employ 28 full-time employees with the
majority working out of our headquarters in Laval and our laboratory in Sherbrooke. 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.
Intercorporate Relationships
We have no subsidiaries.
B.
Our Business
We are a biopharmaceutical innovator focused on the research, development and commercialization of prescription drugs using omega-3 fatty acids, or OM3, delivered
both as free fatty acids and bound-to-phospholipid esters, or PLs, 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 therapeutic, which we are developing initially
for the treatment of severe HTG, a condition characterized by very high or severe levels of TGs in the bloodstream (≥ 500 mg/dL). In accordance with a study published in 2009
in the Archives of Internal Medicine by Ford et al., it is estimated that three to four million people in the United States have severe HTG. In primary qualitative market research
studies commissioned by Acasti in August 2016 and November of 2017 by DP Analytics, a division of Destum Partners, Key Opinion Leaders (KOLs), High Volume
Prescribers (HVPs) and Pharmacy Benefit Managers who were interviewed indicated a significant unmet medical need exists for an effective, safe and well-absorbing OM3
therapeutic that can also demonstrate a positive impact on the major blood lipids associated with cardiovascular disease, or CVD, risk. We believe that CaPre will address this
unmet medical need, if our Phase 3 results reproduce what we observed in our Phase 2 data. We initiated TRILOGY, our Phase 3 clinical program in North America, during the
second half of 2017 and started clinical site activation as planned at the end of 2017. As of the date of this annual report, patient enrollment and randomization have been
completed, and the two TRILOGY Phase 3 studies continue on schedule to report topline results by December 2019 for TRILOGY 1, and January 2020 for TRILOGY 2. We
also believe the potential exists to expand CaPre’s initial indication to the roughly 36 million patients with high TGs in the mild to moderate range (e.g., blood levels between
200 - 499 mg/dL), although at least one additional clinical trial would likely be required to support FDA approval of a Supplemental New Drug Application (SNDA) to expand
CaPre’s indication to this segment. Data from our Phase 2 studies indicated that CaPre may have a positive effect in diabetes and other inflammatory diseases; consequently, we
may also 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 consistent results with CaPre, and we are seeking to demonstrate similar safety and efficacy in our TRILOGY
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;
no deleterious effect on low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, with the potential to reduce LDL-C;
potential to increase high-density lipoprotein cholesterol (HDL-C), or “good” cholesterol;
potential to benefit diabetes patients by decreasing hemoglobin A1c (HbA1c), a marker of glucose control;
good bioavailability (absorption by the body), even under fasting conditions;
no significant food effect when taken with either low-fat or high-fat meals; and
an overall safety profile similar to that demonstrated by currently marketed OM3s.
We believe that if we are able to reproduce these results in our TRILOGY Phase 3 program, we potentially could set CaPre apart from current FDA-approved fish oil-derived
OM3 treatment options, and it could give us a significant clinical and marketing advantage.
About Hypertriglyceridemia (HTG)
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-fat 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 (≥ 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. 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 of
patients with TGs > 150mg/dL and HDL-C < 40mg/dL. Recently published meta-analyses by Alexander et al. (Mayo Clinic Proceedings, 2017) and Maki et al. (Journal of
Clinical Lipidology, 2016) suggest that EPA and docosahexaenoic acid, or DHA, may be associated with reducing coronary heart disease risk to a greater extent in populations
with elevated TG levels, and that drugs lowering TG and TG-rich lipoproteins may reduce cardiovascular event risk in patients with elevated TG levels, particularly if
associated with low HDL-C. More recently in November of 2018, Amarin published the results of their REDUCE-IT cardiovascular outcome trial (CVOT), which showed that
a therapeutic dose of VASCEPA at 4 grams per day, taken on top of a statin, reduced residual cardiovascular risk by 25%. Astra Zeneca is currently investigating the potential
for EPANOVA, their therapeutic OM3 containing both EPA and DHA, taken with a statin to reduce cardiovascular risk in patients with elevated levels of TGs and low HDL-C
in their ongoing STRENGTH CVOT, the results of which are expected to be published in 2020. A table summarizing the various outcome studies conducted over
approximately the last decade is set forth below. The data from these trials support the conclusion that lowering TGs in an “at risk” patient population with the right dose of a
therapeutic drug – independent of the drug class – significantly reduces CVD risk.
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About CaPre
CaPre is a highly purified, proprietary krill oil-derived mixture containing polyunsaturated fatty acids, or PUFAs, primarily composed of OM3 fatty acids, principally
eicosapentaenoic acid, or EPA, and docosahexaenoic acid, or DHA, present as a combination of phospholipid esters and free fatty acids. EPA and DHA are well known to be
complementary and beneficial for human health, and according to numerous recent clinical studies, may promote healthy heart, brain and visual function (Kwantes and
Grundmann, Journal of Dietary Supplements, 2014), and may also contribute to reducing inflammation and blood levels of TGs (Ulven and Holven, Vascular health and risk
management, 2015). Krill is a rich 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. Both forms allow 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, which are transported either by TGs (as in dietary supplements) or as ethyl esters as in other prescription OM3 drugs (such
as LOVAZA and VASCEPA). These OM3 ethyl ester prescription products must 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 content of a meal – the higher the fat content, the
better the OM3 ethyl ester absorption. High fat content meals are not recommended in patients with HTG. We believe that CaPre’s superior absorption profile could represent a
significant clinical advantage, since taking it with a low-fat meal represents a healthier and more realistic 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 exercise, and can 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.
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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. According to the American Heart Association, in 2016, CVD cost
the American healthcare system $555 billion. By 2035, the cost is estimated to increase to $1.1 trillion;
Evidence suggests potential for OM3s in other cardiometabolic indications, such as diabetes and high blood pressure;
Subgroup analyses from outcome studies conducted since 2007 such as JELIS, ACCORD-Lipid and AIM-HIGH, have all shown that patients who entered these
studies with high TGs (above 150 mg/dl) and low HDL (below 40 mg/dl) and received a TG-lowering medication (either an OM3, fibrate or niacin) saw a relative
cardiovascular risk reduction of 31 – 53% by the end of the study when compared to placebo or standard of care;
Based on the assumption that the REDUCE-IT trial sponsored by Amarin and the STRENGTH trial sponsored by Astra Zeneca, would be positive, key opinion
leaders interviewed by DP Analytics in the market research study conducted in 2018 before the results of REDUCE-IT were announced and described further below,
estimated that they would increase their own prescribing of OM3s by 43% in patients with high TGs (blood levels between 200 – 499 mg/dL) and by 35% in patients
with severe HTG (based on qualitative market research with Key Opinion Leaders (KOLs) and High Volume Prescribers (HVPs) conducted for Acasti in November,
2017 by Destum Partners, an independent market research firm);
In February 2019, following the release of the REDUCE-IT results in September 2018, Cantor Fitzgerald projected that based on their market research, prescriptions
for OM3s are expected to grow in 2019 by 100%. The most recent (March 2019) audited prescription data from Symphony Health Analytics indicates that
VASCEPA sales in March 2019 had increased by 77% over March 2018; and
Some analysts who cover the HTG segment of the market are now projecting that this market could reach $10 billion or more in the US alone over the next few
years.
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 (approximately 70 million people) in
the United States have elevated levels of TGs ((TGs >150 mg/dL) (Ford, Archives of Internal Medicine, 2009; 169(6):572-578), including approximately 3 to 4 million people
diagnosed with severe HTG (Miller et al. Circulation, 2011 and Maki et al. J. Clin. Lipid, 2012). 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 (Ford, Archives of Internal Medicine, 2009; 169(6):572-578; Kapoor and Miller, ACC, 2016,
Christian et al. Am. J. Cardiology, 2011). We believe this data indicates there is a large underserved market opportunity for CaPre.
CaPre’s target market in the United States for treatment of HTG was estimated by Symphony Health Analytics Audit data to be approximately US$1.4 billion in 2018, with
approximately 4.5 million prescriptions written annually. The total global market for treatment of HTG was estimated by GOED Proprietary Research in 2015 to be
approximately US$2.3 billion annually. Currently, all marketed OM3 products are approved by the FDA only for patients with severe HTG. We believe there is the potential to
greatly expand the treatable market in the United States to the approximately 70 million people with TGs above 150 mg/dl, assuming the FDA approves expanded labeling for
VASCEPA based on the recent positive REDUCE-IT outcome study results, and favorable results are reported from the STRENGTH outcome trial, which is currently ongoing
and expected to report sometime in 2020. These CV studies were designed to evaluate the long-term benefit of lowering TGs on CVD risk with prescription drugs containing
OM3 fatty acids in patients with mild to moderately elevated TGs, low HDL-C, and concurrently taking a statin. Additional clinical trials would likely be required for CaPre to
also expand its label claims to this segment. Given the large portion of the adult population in the United States that have elevated levels of TGs above 150 mg/dL 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 based on the positive REDUCE-IT results
and provided the outcome of the STRENGTH trial is also positive.
CaPre currently 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. Generic LOVAZA became available on the U.S. market in 2013. In spite of generic options, 2017 audited prescription data from IMS NSP
indicates that approximately 70% of OM3 prescriptions are written for branded products (predominantly VASCEPA). According to the most recently available Symphony
Health Analytics Audit data from April 2019, the U.S. OM3 market for HTG was valued at approximately $1.4 billion in 2018. However, the number of prescriptions written
for OM3s is now increasing significantly since Amarin announced its REDUCE-IT results in late 2018. Some analysts are predicting that this trend will continue, driving
substantial market growth. For example, in February 2019, Cantor Fitzgerald projected that based on their market research based on interviews with 50 physicians, they expect
prescriptions for OM3s to grow in 2019 by 100%.
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We conduct market research at least annually with physicians and payers to monitor market developments and clinical practice. Except as otherwise indicated, all of the
information that follows under this section has been derived from secondary sources, including audited U.S. prescribing data, and from qualitative U.S. primary market research
with physicians and payers conducted for us by DP Analytics, a division of Destum Partners, Inc., or Destum, and other well-respected third party survey providers.
Destum utilized secondary market data and reports to develop market projections for us, and they also conducted primary qualitative market research with physicians and third-
party payers, such as PBMs. One-on-one in-depth phone interviews conducted in November 2017 lasting on average 30-60 minutes were conducted with 22 physicians and 5
PBMs. Key insights and data were collected by Destum on current clinical practice for treating patients with HTG, and physician and payer perceptions of the current unmet
medical and key economic needs in this space. All interviews were conducted by the same individual at Destum to ensure consistency in the collection of key information.
Destum utilized OM3 prescription data from 2009 to 2017 to estimate the size of CaPre’s 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 Destum’s study, key opinion leaders (KOLs) and high volume prescribers (HVPs), were provided with a study questionnaire
and were asked to comment on a target profile for a potential new OM3 “Product X” delivering 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 product’s 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 Phase 3 program.
In the market research for us, 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 in 2016 indicated that they believe that the current unmet medical need for treating
HTG was moderate to high. That number increased to 100% in the subsequent December 2017 research. The reasons identified by these physicians for their dissatisfaction with
the currently available OM3s included insufficient lowering of TGs (a complaint principally related to VASCEPA), negative LDL-C effects (a complaint principally related to
LOVAZA), the “food effect” or reduced absorption of both LOVAZA and VASCEPA when taken with a low-fat meal (or the corollary to this concern which is that their
patients had to take either drug with a fatty meal to get full efficacy benefit), gastrointestinal side effects, and the fishy taste from these fish oil-derived OM3s. Physicians
reported that their patients have difficulty swallowing the large 1 gram softgel capsules of VASCEPA and LOVAZA, and they worried about these issues contributing to patient
non-compliance. 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 to the blinded Target Product Profile of CaPre in the Destum Market Research studies. In the most recent study conducted in
December 2017, they indicated that they would prescribe a new OM3 drug with the Target Product Profile to approximately 82% of their patients in the severe HTG patient
population and 68% of their patients in the high HTG segment within two years of the new OM3 drug’s approval. Approximately 60% of the interviewed physicians indicated
that they would switch to a drug with the Target Product Profile primarily due to the “trifecta effect” of reducing TGs and LDL-C while elevating HDL-C, and the remaining
40% indicated they would switch primarily due to a drug with the Target Product Profile due to the effective reduction of TGs alone. In connection with their responses, the
interviewed physicians were instructed to assume the drug with 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 subsequently supported by our interviews with leading PBMs in
the United States.
This market research was updated in March 2019 to reflect the current views of physicians and third party payers following the publication of the REDUCE-IT study results.
This updated primary qualitative market research project was conducted by a well-respected third party survey provider, and the design of the study was similar to the Destum
project, with one-on-one interviews lasting approximately 60 minutes in duration. These interviews were conducted with 10 physicians and 20 pharmacy directors, covering
179,913,005 commercial lives across the United States, consistent with the current payer mix for the OM3 market. CaPre was evaluated positively by physicians with particular
value placed on its potential to lower TGs, LDL-C, and HbA1c (this was seen as unique, and especially valued), and to increase HDL-C, as well as its potentially superior
tolerability features (e.g. easier to swallow when compared to the ethyl ester fish oils, and no fishy taste or "burpiness"). Importantly, since this research was conducted after the
REDUCE-IT trial outcome results, the lack of clinical outcomes data for CaPre at launch was generally not seen as problematic for the majority of the physicians interviewed.
On average, physicians indicated that they would begin prescribing CaPre 3 months after launch and would evaluate its performance in their initial patients after 3 to 6 months
of use. Depending on favorable experience in initial use, some physicians indicated peak use could begin as quickly as 12 to 18 months after launch. Physicians expect CaPre to
be priced similar to VASCEPA, and to have an out-of-pocket cost of approximately $10-$50. Payers also viewed CaPre favorably and did not anticipate any major
reimbursement restrictions, with likely coverage at Tier 2 or 3 depending on payer plan.
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Based on both primary market research with pharmacy benefit managers, or PBMs, and audited prescription reports, the pricing for branded products currently averages
between US$299 and US$355 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. By the end of 2018, VASCEPA had reached about 45%
market share in the United States, in spite of generic competition from LOVAZA. Amarin continues to gain market share in the United States and, as of the date of this report
has reached approximately 50% of the market share based on dollar. This growth is principally coming from market expansion rather than necessarily from an erosion of
generic sales.
We plan to regularly conduct additional market research with KOLs, HVPs, primary care physicians and payers to further develop and refine our understanding of the potential
market for CaPre ahead of commercial launch in the United States.
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 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 unlike LOVAZA, CaPre may actually reduce LDL-C with a 4 gram per day dose (a dose equivalent to VASCEPA and LOVAZA). 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 significantly reduced non-HDL-C (all cholesterol
contained in the bloodstream except HDL-C), which is also considered to be a marker of 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 analysis of the data from our on-going TRILOGY Phase 3 program will be required to demonstrate CaPre’s statistical
significance with respect to lowering LDL-C and increasing HDL-C. Finally, we saw a statistically significant reduction of HbA1c in the CaPre 4g treatment group in the COLT
study after only 8 weeks on drug. This interesting and potentially differentiating effect will be investigated more thoroughly in our TRILOGY Phase 3 program, where a larger
proportion of the patients are diabetic, and they will be followed for 6 months.
We believe that these multiple potential cardiometabolic benefits, if confirmed in our on-going TRILOGY 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 all four of these important blood lipids (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. For 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 that those 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 CaPre’s 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 this data was subsequently published in the peer-reviewed
Journal of Clinical Therapeutics.
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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 DHA and/or EPA. 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 formulated
as a combination of 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. This is 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 ongoing TRILOGY Phase 3 program, as we believe blood levels of EPA and DHA
should translate into efficacy of TG reduction. This study gives us confidence that 4 grams/day of CaPre could be as effective in lowering TGs as LOVAZA. Our Phase 3
TRILOGY clinical program will confirm if this hypothesis is correct.
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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 CaPre’s 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.
Our CAP13-101 Study for 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 only 10% of patients had severe HTG (levels between 500 and 877 mg/dL),
which was the maximum level of TGs permitted by Health Canada’s 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.
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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), CaPre’s
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. Note
also that VASCEPA’s TG lowering results from the MARINE study were inflated due to a significant placebo effect. This resulted in VASCEPA’s placebo-corrected TG
reduction being overstated by about 10%.
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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 CaPre’s 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 trial). 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 ongoing TRILOGY Phase 3 program.
VASCEPA’s TG lowering results from the ANCHOR study were also inflated due to a placebo effect from their use of mineral oil. This resulted in VASCEPA’s placebo-
corrected TG reduction being overstated by about 6% in this study.
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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:
·
·
·
·
beneficial clinical effects on other blood lipids, such as HDL-C (good cholesterol) and non-HDL-C;
no deleterious effect on, and may potentially reduce, LDL-C (bad cholesterol) levels;
potential to benefit diabetes patients by reducing HbA1c, an important marker of diabetes; and
absorption capability that, unlike VASCEPA and LOVAZA, 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.
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.
CaPre’s 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 in compliance with Good Laboratory Practices (GLPs) 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 behavioral 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 at doses well above CaPre’s anticipated clinical therapeutic dose of 4 grams daily.
In parallel to our TRILOGY Phase 3 program, we are currently completing additional nonclinical studies, including a pre- and postnatal development study in rodents and
a 26-week oral carcinogenicity study in transgenic homozygous rasH2 mice. Both study protocols were pre-approved by the FDA by means of Special Protocol Assessment
(SPA) through the FDA’s Executive Carcinogenicity Assessment Committee. These nonclinical studies are required to support an NDA filing for CaPre.
Our TRILOGY Phase 3 Program
In March 2017, we announced our plans to proceed with our TRILOGY 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 are now actively conducting two pivotal, randomized, placebo-controlled, double-blinded Phase 3 studies to evaluate the safety and
efficacy of CaPre in patients with severe HTG. These studies of 26-week duration will evaluate CaPre’s ability to lower TGs from baseline in approximately 500 patients
(approximately 250 per study) randomized to either 4 grams daily or placebo. The FDA’s feedback supported our plan to conduct two studies in parallel, potentially reducing
the cost and shortening the time to an NDA submission. These studies are being conducted in approximately 150 sites across North America.
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The primary endpoint of these studies is to determine the efficacy of CaPre at 4 grams/day compared to placebo in lowering TGs after 12 weeks in severe HTG patients,
and to confirm safety by continuing to follow these patients for the full 26 weeks. The study was designed to provide at least 90% statistical power to detect a difference of at
least a 20% decrease from baseline in TGs between CaPre and placebo. In addition, the Phase 3 studies will include numerous secondary and exploratory endpoints, which are
designed to assess the effect of CaPre on the broader lipid profile and certain metabolic, inflammatory and CVD risk markers.
In November 2017, we announced that Dariush Mozaffarian, M.D., Dr.P.H., agreed to serve as the principal investigator of our Phase 3 clinical program. Dr. Mozaffarian
is a cardiologist and epidemiologist serving as the Jean Mayer Professor of Nutrition & Medicine, and the Dean of the Friedman School of Nutrition Science & Policy at Tuft’s
University. His widely published research focuses on how diets, such as those rich in OM3s, and lifestyle influence cardiometabolic health and how effective policies can
improve health and wellness.
Late in 2017, based on feedback from the FDA, we finalized our Chemistry, Manufacturing, and Controls plans and the clinical trial design that supports our TRILOGY
Phase 3 program. In parallel with our Phase 3 clinical trial planning, additional current Good Manufacturing Practices (cGMP) production lots of API (known as NKPL66) and
CaPre were manufactured, enabling us to build the CaPre and placebo inventory required to support the activated clinical trial sites and complete patient randomization. In the
first calendar quarter of 2018, additional raw krill oil was purchased and additional lots of CaPre have been manufactured with this material for use in our Phase 3 program.
With manufacturing of clinical trial material complete, we are now allocating additional technical resources to other activities related to the scale-up of manufacturing for the
planned commercial launch of CaPre in 2021.
We initiated our TRILOGY Phase 3 program and began site activation and patient enrollment on schedule at the end of 2017. We are working with a major clinical
research organization to manage our TRILOGY Phase 3 program. The TRILOGY studies continued to progress on schedule throughout 2018, and as of the date of this annual
report, they remain on schedule for delivery of topline results for TRILOGY 1 in December 2019, and TRILOGY 2 in January 2020. As of June 2019, our two on-going Phase
3 TRILOGY trials had reached 100% patient randomization at more than 150 clinical sites across the United States, Canada, and Mexico, and more than 60% of the patients in
both trials had completed their 6-month treatment plan.
Our first study, designated as TRILOGY 1, is being conducted exclusively in the United States and is fully randomized with a total of 245 patients. The TRILOGY 2 study,
which is also fully randomized as of the date of this annual report, also has a total of 245 patients, and is being conducted in the United States, Canada and Mexico. We expect
to report topline results independently for each study as we receive the results.
The following chart illustrates the design and dosing of our TRILOGY Phase 3 program for CaPre.
TRILOGY Phase 3 Clinical Program
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Clinical Trial Process and Timeline
During the second half of 2017, our clinical research organization, or CRO, began the process of identifying a sufficient number of clinical sites with experienced
investigators to conduct the two Phase 3 clinical trials. Site activation involves negotiating a contract, gaining approval from the site’s Institutional Review Board, or IRB, and
delivery of clinical supplies. It was determined that approximately 150 sites across North America would be used to randomize the total of about 500 patients with severe HTG
required to complete the two Phase 3 studies. Site activation was initiated in the fourth quarter of 2017, and was completed in the first half of 2018. Site activation runs
concurrently with patient screening and enrollment in order to secure an adequate number of sites to achieve the patient enrollment goals of the program.
Initiating a clinical trial involves numerous steps to engage investigators to screen and qualify patients as participants, prior to randomizing them to test the investigational
drug. This entire screening and randomization process takes an average of six to nine weeks. Patient recruitment is conducted by each clinical trial site, supported by resources
provided by the CRO. After a patient is identified by the investigator as a possible candidate for the clinical trial, they are screened to determine their eligibility for trial
enrollment. The screening period takes four to six weeks. Patients must meet the inclusion criteria of the study, as described in the trial plan, also known as a protocol. We
expect each patient will require two screening visits with the investigator’s clinical staff, whereby medical history and patient consent are obtained. This further qualification
process takes two to three weeks.
When patient qualification is confirmed, the process of randomization begins. Approximately 245 patients were randomized in each Phase 3 study. This sample size per
study would provide 90% statistical power to detect at least a 20% decrease in TG levels from baseline to week 12 between CaPre and placebo with a two-sided α at 0.05
(primary endpoint), a difference that is believed to be clinically relevant. A randomized controlled trial is designed to reduce bias when testing an investigational treatment. The
process of assigning patients to these groups by chance, rather than choice, is completely blinded, and is called randomization. The groups are referred to as the experimental
group or the control group. In the TRILOGY Phase 3 clinical trials, patients were assigned to either receive CaPre (experimental) or placebo (control). Each patient stays on
CaPre or placebo for a period of 26 weeks.
The two TRILOGY Phase 3 clinical trials proceed to dosing both the experimental and control groups, according to the protocol, to assess CaPre’s efficacy and safety
compared to placebo. In these double-blind studies, neither we, the patients or the investigators know which treatment (experimental drug or placebo) a patient receives. Only
after all data has been recorded and analyzed will we, the investigators and the participants learn which were which. The trial conduct and patient safety are rigorously
monitored to ensure regulatory compliance and to maintain the integrity of the study in order to assess outcomes.
Our Regulatory Strategy for CaPre
Our strategy is to develop and initially commercialize CaPre for the treatment of severe HTG. The TRILOGY Phase 3 program was initiated during the second half of 2017
and has been designed to 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.
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 FDA’s 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. This pathway still
allows CaPre to retain its New Chemical Entity (NCE) status due to its novel, patented OM3 free fatty acid/phospholipid ester formulation.
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 LOVAZA (which has an OM3-acid ethyl esters composition) in healthy volunteers. In February 2017, we met with the FDA at
an End-of-Phase 2 meeting where our Bridging Study data was discussed. 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 program that would be required for NDA approval.
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Our planned remaining key development and regulatory milestones and timeline are presented below.
Our Intellectual Property Strategy
Under a license agreement we entered into with Neptune in August 2008, which was later amended on February 9, 2009 and March 7, 2013 (the “License Agreement”), we
received an exclusive license to use certain intellectual property of Neptune (which includes several patents) to develop and commercialize CaPre and our novel and active
pharmaceutical ingredients, or APIs, for use in pharmaceutical and medical food applications in the cardiometabolic field. The term of the License Agreement expires on the
date of the last-to-expire licensed patents in 2022. As the 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.
On August 8, 2017, Neptune announced that it sold its krill oil inventory and intellectual property to Aker BioMarine Antarctic AS, or Aker. The sold intellectual property
included the intellectual property to which rights were granted us under the License Agreement. As part of that transaction, Aker entered into a patent license agreement with
Neptune pursuant to which it granted to Neptune the right to sublicense to us certain intellectual property as necessary to allow us to maintain our license grant under the
original License Agreement. Accordingly, the license granted to us under the License Agreement remains in force.
Upon the expiry of the License Agreement, we believe that CaPre will be covered under our own issued and pending patents, and we do not believe that we will afterwards
require any licenses to support the commercialization of CaPre.
We currently have patents granted and allowed in the following countries: United States, Canada, Russia, Belgium, Switzerland, Germany, Denmark, Spain, Finland,
France, United Kingdom, Italy, Netherlands, Norway, Portugal, Sweden, Japan, Israel, Australia, China, Mexico, Panama, Saudi Arabia, Taiwan, South Africa, Chile and South
Korea. We continue to expand our own intellectual property, or IP, patent portfolio. We have filed patent applications in more than 20 jurisdictions, including with the European
Patent Office (but excluding the individual countries where we have subsequently registered), and in countries in North America, Asia and Australia for our “Concentrated
Therapeutic Phospholipid Composition”, or Proprietary Composition, to treat HTG. We currently have more than 20 issued or allowed patents (including registered European
countries) and numerous patent applications pending. A patent is generally valid for 20 years from the date of first filing. However, patent terms can be subject to extensions in
some jurisdictions in order to compensate, for example, for delays caused by the patent office during prosecution of the patent application or for regulatory delays during the
pre-market approval process.
Two U.S. patents, U.S. Patent Nos. 8,586,567 and 9,475,830, have issued which relate to the use of concentrated therapeutic phospholipid compositions for treating or
preventing diseases associated with cardiovascular disease, comprising administering an effective amount of a concentrated therapeutic phospholipid composition. More
specifically, U.S. Patent No. 8,586,567 covers a method of reducing serum TG levels comprising administering to a subject an effective amount of a concentrated phospholipid
(PL) composition having, among other things, a concentration of total phospholipids in the composition of approximately 66% (w/w). U.S. Patent No. 9,475,830 covers a
method of treating HTG comprising administering to a subject a therapeutically effective amount of a concentrated therapeutic phospholipid composition, having, among other
things, a concentration of total phospholipids in the composition of approximately 60% (w/w). U.S. Patent No. 10,130,644 (U.S. Patent Application Serial No. 15/258,044) was
granted and covers claims directed towards a composition encompassing an extract comprising a PL content between approximately 60% to approximately 99%. We also filed a
U.S. continuation patent application (U.S. Patent Application Serial No. 16/135212) to pursue claims directed towards a composition encompassing an extract comprising a PL
content between approximately 50% (w/w) to approximately 70% (w/w).
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In 2017, additional patents were granted to us by the Taiwanese, South Korean, and Australian patent offices to protect our Proprietary Composition using compositions of
matter claims and medical use claims. In 2018, we were also granted patents by the Canadian Intellectual Property Office, the European Patent Office (EPO), the Russian Patent
Office, and the Japanese Patent Office for the Proprietary Composition, all of which contain compositions of matter claims and medical use claims. On January 9, 2019, we
announced a Certificate for a European Patent had been issued by the European Patent Office. The granted patent is valid until 2030 and relates to a concentrated phospholipid
composition and method of using the same for modulating blood lipids. This patent was validated in Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, United
Kingdom, Italy, Netherlands, Norway, Portugal and Sweden. We also received notices of allowances for patents in Chile, Mexico and Israel.
We believe these patents and patent applications 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 in force 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. The evidentiary stage in the New Zealand patent opposition has been completed. The next step is
the hearing. In our view, no new prior art has been presented that was not already considered in other jurisdictions, such as in the United States, where our patents are in force.
We have received a notice issued from the Japan Patent Office (JPO) indicating that a third party filed an opposition against our Japanese Patent No. 6346121. We are in
the process of replying by amendment of our claims to the Japanese Patent Office, which we believe would allow us to overcome the prior art cited in the opposition.
The trademark CaPre® is registered in the United States, Canada, Australia, China, Japan and Europe. We are currently in the process of developing a new brand name and
logo for CaPre for launch into the U.S. market. That name, once it is developed, will be trademarked in all of the major jurisdictions around the world. In addition, two PCT
applications that cover our encapsulation apparatus and manufacturing process while maintaining industrial trade secrets and know-how. We also filed a provisional application
directed to our RKO manufacturing process.
Manufacturing of CaPre
We are developing CaPre as a new chemical entity (which means a novel chemical product protected by patents), and we are conducting our TRILOGY 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. In preparation for our TRILOGY Phase 3
program, working together with our pharmaceutical CMOs, we advanced the installation and qualification of the proprietary extraction and purification equipment used to
manufacture CaPre. We ran our first scaled cGMP production lots of CaPre at CordenPharma’s Chenôve facility in Dijon, France during the first half of 2017. We scaled up to
100 kg/day in late 2017 to fulfill the clinical product requirements for our TRILOGY Phase 3 program. We are currently operating at a scale of 20 tons per year, and plan to
scale further to 40 tons to support our initial commercial launch. As of the date of this annual report, we have completed all clinical lots of NKPL66 and CaPre for our
TRILOGY Phase 3 program, and we have made additional safety batches to mitigate any potential loss in shipping.
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 plan to
launch CaPre ourselves in the U.S. market. Our preferred strategy outside the United States is to commercialize CaPre through regional or country-specific strategic
partnerships, and to potentially seek support and funding from each partner for in-country clinical development, registration 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 a
targeted approach to partnering and licensing in various geographies.
Our key commercialization goals include:
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complete our TRILOGY Phase 3 program and, assuming the results are positive, file an NDA by mid 2020 to obtain regulatory approval for CaPre in the United States,
initially for the treatment of severe HTG, with the potential to afterwards expand CaPre’s indication to the treatment of high TGs (although at least one additional clinical
trial would likely be required to expand CaPre’s indication to this segment);
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continue to strengthen our patent portfolio and other intellectual property rights;
continue planning for the potential launch of CaPre in the United States by the second half of 2021; and
continue to pursue 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.
In addition to completing our TRILOGY Phase 3 program, we expect that additional time and capital will be required to complete the filing of an NDA to obtain FDA
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 in the United States.
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 based on the positive REDUCE-IT CVOT by Amarin, and if Astra Zeneca’s
STRENGTH CVOT is successful.
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 45% by the end of 2018. 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. Matinas recently decided to restart their development program for MAT9001, an omega-3 free fatty acid that consists primarily of EPA and
docosapentaenoic acid (DPA). 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, could compete with CaPre.
Raw Materials
We use semi-refined raw krill oil as our primary raw material to produce CaPre. Krill are generally harvested in Antarctic waters. The krill biomass is the world’s most
abundant biomass and it is monitored to help ensure sustainable cultivation. Historically, we sourced all of our krill oil from Neptune. On August 8, 2017, Neptune announced
it was discontinuing krill oil production, and selling its krill oil inventory and intellectual property to Aker. In the three-month period ending December 31, 2017, we purchased
a reserve of krill oil from Neptune and Aker that was used in the production of CaPre capsules for our Phase 3 clinical trials. In addition, krill oil was purchased from Aker,
which was also used in our Phase 3 trials. There are several alternative suppliers of krill oil that we have confirmed can meet our specifications for CaPre. Combined, they have
more than adequate production capacity to meet our future needs.
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. We currently employ 28 full-time employees with the majority
working out of our headquarters in Laval and at our laboratory in Sherbrooke. We generally require all of our employees to enter into invention assignment, non-disclosure and
non-compete agreements. We rely on third-party consultants and contractors from time to time. Our employees are not covered by any collective bargaining agreement or
represented by a trade union.
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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 gram, 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);
the dose dependent effect on fasting plasma TGs in patients with TGs between 500-877 mg/dL (severe HTG); and
the effect of CaPre on fasting plasma levels of LDL-C (direct measurement), HDL-C, non-HDL-C, hs-CRP and OM3 index.
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.
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 group 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 HbA1C mean improvements of 14.4% and 9.8% and 15.0%,
respectively, as compared to standard of care. The 4-gram 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;
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
HbA1C of 15.0%, corresponding to a reduction of 3.5% as compared to an increase of 11.5% for the standard of care group.
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 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.
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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;
the dose dependent effect on fasting plasma TGs in patients with TGs between 500-877 mg/dL; and
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.
CaPre successfully met the TRIFECTA study’s 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;
HDL-C slightly increased at both the 1-gram and 2-gram levels; and
LDL-C and slightly decreased at the 2-gram level.
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 of CaPre. The predominant incidence was
gastrointestinal-related, with no difference between CaPre and placebo. The safety profiles of patients on CaPre and placebo were similar.
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 FDA’s Good Laboratory Practice, or GLP,
regulations;
submission of an investigational new drug application, or IND, which must become effective before human clinical trials may begin in the United States;
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, or cGMP, to establish the safety and efficacy of the proposed drug for its proposed indication;
submission of an NDA for a new drug;
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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 drug’s identity, strength, quality and purity;
satisfactory completion of potential FDA audit of the nonclinical and/or clinical trial sites that generated the data in support of the NDA; and
FDA review and approval of the NDA prior to any commercial marketing or sale of the drug in the United States.
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 sponsor’s 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 drug’s efficacy. Each protocol, and any subsequent amendments to the protocol or new investigator’s 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.
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.
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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 may be 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 product’s 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.
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 and reporting Field Alert information relating
to bacteriological contamination, significant deterioration of the product or failure of distributed product to meet specifications, 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 drug’s 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.
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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 product’s 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.
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.
Fiscal Year 2019 Developments
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On April 20-21, 2018, we hosted a well-attended investigators meeting for the TRILOGY Phase 3 studies in Fairfax, Virginia. The aim of the investigators meeting
was to ensure that the clinical studies are conducted in compliance with the clinical study protocol, guidelines and applicable regulations. Approximately 200
attendees participated in this meeting, which was composed of physicians, study nurses and study coordinators representing 90 of the TRILOGY clinical sites
together with the clinical team of Acasti, our CRO, and the lead Principal Investigator for the TRILOGY studies, Dariush Mozaffarian, M.D., Dr.P.H., who also
presented at the meeting. Dr. Mozaffarian is a highly regarded cardiologist at Tufts University, and his research focuses on the influence of OM3s, diet and lifestyle
on cardiometabolic health.
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On May 9, 2018, we announced the closing of a public offering of 9,530,000 units at a price of $1.05 per unit for aggregate gross proceeds to us of $10,006,500,
with each unit consisting of one common share and one common share purchase warrant. The common share purchase warrants comprising the units are
exercisable at any time prior to May 9, 2023 at an exercise price of $1.31 per common share. On May 14, 2018, we announced that the underwriter had exercised
the over-allotment option in full pursuant to which we issued, on the same date, 1,429,500 additional units upon the same terms as set forth above for additional
aggregate gross proceeds to us of $1,500,975.
On April 27, 2018, we announced the appointment of Donald Olds to our board of directors and audit committee. See “Item 6. Directors, Senior Management and
Employees – Directors and Senior Management.”
On June 4, 2018, we announced the appointment of Mr. Brian Groch as our Chief Commercial Officer. Mr. Groch brings over 25 years of senior experience in the
healthcare and life science industries, including product commercialization, developing and executing global sales strategies, business development, and
operations. Mr. Groch will drive our global commercialization strategy, including U.S. launch planning and execution, and commercial partnering activities in the
rest of the world. See “Item 6. Directors, Senior Management and Employees – Directors and Senior Management.”
As of June 26, 2018, we had activated 110 clinical sites, 463 patients had been enrolled and 41 patients had been randomized for the CaPre TRILOGY Phase 3
program. Additional cGMP production lots of API and CaPre were manufactured during the fourth quarter, enabling us to continue to accumulate the CaPre and
placebo inventory required to support the TRILOGY Phase 3 trials.
On September 24, 2018, we announced that Mr. Jean-François Boily was appointed as the Vice President of Finance and Mrs. Linda O’Keefe, our former Chief
Financial Officer, announced her retirement.
On October 11, 2018, we announced the closing of its underwritten public offering in the United States of 19,090,000 Common Shares on October 9, 2018 (which
included the exercise in full by the underwriters of their over-allotment option to purchase 2,490,000 additional common shares), at an offering price of US$1.00
per common share generating net proceeds to us of approximately $22.6 million (US$17.4 million).
On October 23, 2018, we announced the closing of an underwritten public offering in Canada of 21,562,000 common shares (which included the exercise in full
by the underwriters of their over-allotment option to purchase 2,812,500 additional common shares), at an offering price of $1.28 per common share generating
net proceeds to us of approximately $25.4 million.
On January 9, 2019, we announced a Certificate for a European Patent had been issued to us by the European Patent Office. The granted patent is valid until 2030
and relates to a concentrated phospholipid composition and method of using the same for modulating blood lipids. This patent was validated in Belgium,
Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Italy, Netherlands, Norway, Portugal and Sweden.
On February 21, 2019, we announced announces we had been recognized by the TSX Venture Exchange in its “2019 Venture 50,” a ranking of the strongest
companies on TSX Venture Exchange by share price, trading volume and market capitalization.
On April 1, 2019, we announced publication of CaPre’s bioavailability study in a leading peer-reviewed journal. This study further validated our prior study
results demonstrating that the bioavailability of CaPre is significantly better than LOVAZA when taken with a low-fat meal.
As of June 3, 2019, 100% of the required total patients for our two TRILOGY Phase 3 studies had been randomized, and more than 60% of patients who had
previously been randomized in our TRILOGY program had already completed their 6-month treatment plans. This progress supports management’s expectation
for announcing topline results of TRILOGY 1 before the end of calendar 2019 and topline results of TRILOGY 2 in January 2020.
C.
Organizational Structure
We have no subsidiaries.
D.
Property, Plants and Equipment
Our head office and operations are located at 545, Promenade Centropolis, suite 100, Laval, Québec, Canada, H7T 0A3 and our R&D and quality control laboratory is
located at Espace Lab, 2650 Maximilien-Chagnon, Sherbrooke, Québec, Canada, J1E0M8. 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 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.
- 45 -
We have entered into an agreement CordenPharma Chenôve, a third party CMO, for the manufacturing of CaPre clinical material for the purposes of our ongoing
TRILOGY 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 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.
Management’s Discussion and Analysis of Financial Situation and Operating Results Fiscal Years Ended March 31, 2018 and 2019
Introduction
This management’s discussion and analysis (“MD&A”) is presented in order to provide the reader with an overview of the financial results and changes to our financial
position as at March 31, 2019 and for the year then ended. This MD&A explains our material variations in the financial statements of operations, financial position and cash
flows for the year ended March 31, 2019 and 2018, thirteen-month and one-month periods ended March 31, 2017 and the twelve-month period ended February 28, 2017.
This MD&A must be read in conjunction with our audited financial statements for the year ended March 31, 2019 and 2018, and the thirteen-month period ended March
31, 2017. Our audited financial statements were prepared in accordance with International Financial Reporting Standards (“IFRS”), as issued by the International Accounting
Standards Board. 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, is also used to assess our operating performance. This non-IFRS financial measure is directly 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, and 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 management, and to better understand its
historical and future financial performance.
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 its 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.
- 46 -
We calculate our non-IFRS operating loss measurement by adding to net loss finance expenses that includes change in fair value of derivative warrant liabilities and foreign
exchange gain (loss), depreciation and amortization, impairment loss, litigation settlement expected to be paid via common shares, and stock-based compensation and by
subtracting finance income and deferred tax recovery. Items that do not impact our core operating performance are excluded from the calculation as they may vary significantly
from one period to another. We also exclude the effects of certain non-monetary transactions recorded, such as stock-based compensation and litigation settlement expected to
be paid via common shares, from our non-IFRS operating loss calculation. Excluding this item does not imply it is necessarily non-recurring.
A reconciliation of net loss to non-IFRS operating loss is presented later in this MD&A.
Basis of Presentation of the Financial Statements
We are subject to a number of risks associated with our ongoing priorities, including the conduct of our clinical program and its results, the establishment of strategic
alliances and the development of new pharmaceutical products and their marketing. Our current product in development requires approval from the FDA and equivalent
regulatory organizations in other countries before its sale can be authorized. Certain risks have been reduced for the longer term with the outcome of our actions, including our
intellectual property strategy execution with filed patent applications in more than 20 jurisdictions, with more than 20 issued patents and with numerous additional patent
applications pending. We have incurred significant operating losses and negative cash flows from operations since our inception. To date, we have financed our operations
through the public offering and private placement of common shares (with or without warrants) 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. Our ability to complete the needed financing and ultimately achieve
profitable operations is dependent on a number of factors outside of our control. See Item 3 “Risk Factors” in this MD&A.
We have incurred operating losses and negative cash flows from operations since inception. Our current assets of $37.3 million as at March 31, 2019 include cash and cash
equivalents totaling $22.5 million, and marketable securities of $11.9 million mainly generated by the net proceeds from our recent securities offerings. Our current liabilities of
$18.2 million at March 31, 2019 are comprised primarily of amounts due to or accrued for creditors. Management projects that additional funds will be needed in the future,
after TRILOGY phase 3 clinical trials for activities necessary to prepare for CaPre’s commercial launch, including the scale up of our manufacturing operations, the completion
of the potential regulatory (NDA) submission package (assuming positive Phase 3 clinical results), and the expansion of business development and U.S. commercial launch
activities. We are working towards the development of strategic partner relationships, as well as actively seeking additional non-dilutive funds in the future, but there can be no
assurance as to when or whether we will complete any strategic collaborations or succeed in identifying non-dilutive funding sources. Consequently, we may need to raise
additional equity capital in the future to fund these activities. In particular, raising additional capital is subject to market conditions and is not within our control. If we do not
raise additional funds or find one or more strategic partners, we 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.
The 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. 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 we are unable
to continue as a going concern, material write-downs to the carrying values of our assets, including our intangible asset, could be required.
- 47 -
Selected Financial Information
Net loss
Basic and diluted loss per share
Non-IFRS operating loss1
Total assets
Working capital2
Total non-current financial liabilities
Total equity
Three-month periods ended
March 31,
March 31,
March 31,
Year ended One-month ended
March 31,
March 31,
2019
$
(16,806)
(0.22)
(12,095)
48,471
19,085
16,263
13,962
2018
$
(8,140)
(0.32)
(6,427)
22,959
2,795
8,038
8,224
2019
$
(51,566)
(0.95)
(40,157)
48,471
19,085
16,263
13,962
2018
$
(21,504)
(1.23)
(16,095)
22,959
2,795
8,038
8,224
2017
$
(769)
(0.05)
(406)
25,456
8,143
1,615
21,703
Thirteen-month
period
ended
March 31,
2017
$
(11,247)
(1.01)
(7,798)
25,456
8,143
1,615
21,703
Comments on the Significant Variations of Results from Operations for the Three-Month Periods, Years Ended March 31, 2019 and 2018 and the Thirteen-Month Period
Ended March 31, 2017
The net loss totaling $16,806 or ($0.22) per share for the three months ended March 31, 2019 increased by $8,666 or $0.10 per share from the net loss totaling $8,140 or
($0.32) per share for the three months ended March 31, 2018. The increase in net loss was resulted primarily from the $5,668 increased non-IFRS operating loss generated by
planned research and development expenses to execute the TRILOGY Phase 3 clinical program as well as from a $2,084 (see “Reconciliation of Net Loss to Non-IFRS
Operating Loss”) increase in financial expenses due mostly to a loss related to the increase in value of the warrant derivative liability of $2,055. These losses were also affected
by the legal settlement expected to be paid via common shares of $990 in addition to the increased depreciation and amortization expense of $64, offset by decreased stock-
based compensation of $140.
The net loss totaling $51,566 or ($0.95) per share for the year ended March 31, 2019 increased by $30,062 from the net loss for the year ended March 31, 2018 while the
loss per share decreased by ($0.28) per share from the loss of ($1.23) per share for the year ended March 31, 2018. The per share loss decreased due to the issuance of
52,494,519 common shares primarily in connection with the public financings that occurred in May and October 2018. The increased net loss resulted primarily from the
$24,062 increased non-IFRS operating loss generated by planned research and development expenses to execute the TRILOGY Phase 3 clinical program, as well as increases in
stock-based compensation of $112 and depreciation and amortization of $155. The increase in loss is also affected by the loss related to the legal settlement with our former
CEO expected to be paid via common shares of $990 and the reimbursement of related legal fees of $64. These increased losses were further increased by a net increase of
$4,743 in financial expenses, due mostly to a loss related to increased value of the warrant derivative liability of $5,943 (see “Reconciliation of Net Loss to Non-IFRS Operating
Loss”), offset by a decrease of $481 in derivative warrant liability-related transaction costs and by the remaining gains of $311 due to a foreign exchange gain as well as an
increase in interest income of $403. The foreign exchange gain is mostly due to the U.S. cash flows generated by the U.S. public financing of US$17.4 million that took place
on October 9, 2018 and the U.S. denominated accounts payable, as well as the strengthening of the U.S. dollar in relation to the Canadian dollar functional currency. At the time
of the U.S. public financing, a major portion of the net offering was invested in U.S. dollar investments as per our treasury policy (see “Treasury Operations”). The increase in
interest income is a result of the increase in marketable securities and cash equivalents investments as per our treasury policy. As at March 31, 2019 cash equivalents and
marketable securities amounted to $34,413 versus $8,249 as at March 31, 2018.
The net loss totaling $21,504 or ($1.23) per share for the year ended March 31, 2018 increased by $10,257 or ($0.22) per share from the net loss totaling $11,247 or
($1.01) per share for the thirteen-month period ended March 31, 2017. This resulted primarily from the $8,297 increased non-IFRS operating loss, a $1,642 increase in financial
expense, a $255 increase in stock-based compensation, and a decrease of $129 in deferred tax recovery offset by a $66 decrease in depreciation and amortization.
______________________________
1 The non-IFRS operating loss (adding to net loss financial expenses (income), depreciation and amortization, change in fair value of derivative warrant liabilities and stock-based compensation) is not a
standard measure endorsed by IFRS requirements. A reconciliation to net loss is presented below. On May 10, 2019 we announced the settlement regarding legal claims made by our former chief executive
(“CEO”) officer with respect to the termination of his employment. Pursuant to the settlement agreement, we have agreed to issue 900,000 common shares at $1.10 per share to the former CEO. In addition,
we have agreed to reimburse the former CEO for legal fees of $64. Furthermore, pursuant to the settlement agreement, we have received a full and final release from the former CEO on all procedures in
connection with the termination of his employment. This settlement has been accrued as at March 31, 2019 and the expense of $990 is included as part of general and administrative expenses.
2 Working capital is presented for information purposes only and represents a measurement of our short-term financial health. 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.
- 48 -
Breakdown of Major Components of the Statement of Earnings and Comprehensive Loss
Research and Development Expenses
Salaries and benefits
Research contracts
Professional fees
Other
Government grants and tax credits
Total before stock-based compensation and depreciation and amortization
Stock-based compensation
Depreciation and amortization
Total
General and Administrative Expenses
Salaries and benefits
Administrative fees
Professional fees
Other
Total before stock-based compensation and legal settlement expected to be paid via
common shares
Stock-based compensation
Legal settlement expected to be paid via common shares
Total
Three-month periods ended
Year ended
March 31,
2019
$
676
9,358
81
183
(298)
10,000
64
731
10,795
March 31,
March 31,
2018
$
615
4,719
248
38
(325)
5,295
91
667
6,053
2019
$
1,805
32,850
719
506
(588)
35,292
247
2,827
38,366
Three-month periods ended
Year ended
March 31,
2019
$
934
8
775
378
2,095
64
990
3,149
March 31,
March 31,
2018
$
584
14
428
106
1,132
177
-
1,309
2019
$
2,305
34
1,732
794
4,865
794
990
6,649
March 31,
2018
$
1,705
9,381
1,790
222
(409)
12,689
308
2,672
15,669
March 31,
2018
$
1,576
121
1,347
362
3,406
621
-
4,027
Three-Month Period Ended March 31, 2019 Compared to the Three-Month Period Ended March 31, 2018
During the three months ended March 31, 2019 we continued our planned advancement of the two-study TRILOGY Phase 3 clinical study program for our drug candidate,
CaPre, in partnership with one of the world’s largest providers of biopharmaceutical development and clinical outsourcing services (“CRO”). The $10,795 in total research and
development expenses for the three-months ended March 31, 2019 totaled $10,000 before depreciation, amortization and stock-based compensation expense, compared to
$6,053 in total research and development expenses for the three-months ended March 31, 2018 or $5,295 before depreciation, amortization and stock-based compensation
expense. There is a $4,705 increase in research and development expenses before depreciation, amortization and stock-based compensation which was mainly attributable to a
$4,639 increase in research contracts, a $61 increase to salaries, a $27 increase to government grants and tax credits and a $145 increase to other research and development
expenses, offset by $167 decrease in professional fees. Higher research contract expenses resulted primarily from a $3,988 increase in the CRO’s Phase 3 clinical trial program
contract expense with continued site activation and patient enrollment, randomization and treatment. The decrease in professional fees is made up mostly of a $159 decrease in
legal fees relating to services for contracting and due diligence activities performed during the three-months ended March 31, 2018.
General and administrative expenses totaling $2,095 before stock-based compensation expense for the three months ended March 31, 2019 increased by $963 from $1,132
for the three months ended March 31, 2018. This $963 increase was mainly attributable to a $350 increase in salaries and benefits, an increase of $347 related to professional
fees, an increase of $272 related to other fees. The $350 increase in salaries and benefits primarily resulted from the hiring of a Chief Commercial Officer to support expanded
business and market development activities. The professional fee increase of $347 was due in part to additional legal fees resulting from independence from Neptune, including
no continued internal counsel services. Finally, the $272 increase in other expenses is associated with risk management programs now also independent of Neptune.
- 49 -
Stock-based compensation and depreciation and amortization included in both research and development and general and administrative expenses are explained in the
following discussion of reconciliation of Net Loss to Non-IFRS Operating Loss.
Year ended March 31, 2019 Compared to the Year Ended March 31, 2018
As we continue advancing our planned TRILOGY Phase 3 clinical program and production scale-up of CaPre within its research and development program, $38,366 was
incurred in total research and development expenses for the year ended March 31, 2019 and $35,292 was incurred before depreciation, amortization and stock-based
compensation expense. This compares to $15,669 in total research and development expenses for the year ended March 31, 2018 or $12,689 before depreciation, amortization
and stock-based compensation expense. The $22,603 increase in research and development expenses before depreciation, amortization and stock-based compensation was
mainly attributable to the $23,469 increase in contracts with a $22,272 increase in Phase 3 CRO contract expenses and $1,196 of increased research contracts resulting from the
planned scale-up of CaPre production activities in the year ended March 31, 2019. An increase of $100 in salaries and benefits relates to the increased headcount. These
increases are offset by a $1,071 decrease in legal fees for contracting and due diligence activities, as well as the $179 increase in tax credits which relates to higher research and
development expenditures combined with a higher investment.
General and administrative expenses totaling $4,865 before stock-based compensation expense for the year ended March 31, 2019 increased by $1,459 from $3,406 for the
year ended March 31, 2018. This increase was mainly attributable to a $729 increase in salaries and benefits primarily resulting from the expansion of the team to become
independent of Neptune, and the expansion of our commercialization team and business development activities. Professional fees increased by $385 due in part to additional
legal fees resulting from independence from Neptune. Additionally, professional fees increased due to implementation of a new ERP system. An increase of $432 of other
general and administrative expenses associated with risk management programs as we became independent of Neptune. These increases were partially offset by an $87
reduction in Neptune’s administrative fees.
Stock-based compensation and depreciation and amortization included in both research and development and general and administrative expenses are explained in the
following discussion of reconciliation of Net Loss to Non-IFRS Operating Loss.
Reconciliation of Net Loss to Non-IFRS Operating Loss
Net loss
Add (deduct):
Stock-based compensation
Depreciation and amortization
Legal settlement – expected to be settled in common shares
Financial expenses
Non-IFRS operating loss
Three-month periods ended
Year ended
March 31,
2019
$
(16,806)
128
731
990
2,862
(12,095)
March 31,
March 31,
2018
$
(8,140)
268
667
-
778
(6,427)
2019
$
(51,566)
1,041
2,827
990
6,551
(40,157)
March 31,
2018
$
(21,504)
929
2,672
-
1,808
(16,095)
For the three-month period and year ended March 31, 2019 we recognized stock-based compensation under our compensation plans in the amount of $128 and $1,041,
respectively, compared to the three-month and year ended March 31, 2018 totalling $268 and $929 respectively. The weighted average grant date fair value of the options
granted to employees and directors during the year ended March 31, 2019 was $0.51 compared to the grant date value of options granted in the year ended March 31, 2018 of
$1.22, whereas an increase of 1,052,023 of number of options granted occurred, with total granted stock options of 2,173,523 for the year ended March 31, 2019 compared to
1,121,500 stock options granted for the year ended March 31, 2018. No stock options were granted during the three-month periods March 31, 2019 and 2018. No options were
granted to consultants.
The depreciation and amortization expense increased by $64 to $731 for the three months ended March 31, 2019 from $667 for the three months ended March 31, 2018.
The depreciation and amortization expense increased by $155 to $2,827 for the year ended March 31, 2019 from $2,672 for the year ended March 31, 2018. The depreciation
increased due to encapsulation production equipment being put into use during the three months ended March 31, 2019 and therefore related depreciation commencing.
- 50 -
Legal settlement expected to be paid via common shares relates to the settlement regarding legal claims made by our former CEO with respect to the termination of his
employment. Pursuant to the settlement agreement, we have agreed to issue 900,000 common shares at $1.10 per share to the former CEO. Furthermore, pursuant to the
settlement agreement, we receive a full and final release from the former CEO on all procedures in connection with the termination of his employment. This settlement amount
of $990 has been accrued as at March 31, 2019, included as part of general and administrative expenses thus increasing the loss.
Financial expenses increased by $2,084 from a loss of $778 for the three months ended March 31, 2019 to a loss of $2,862 for the three months ended March 31, 2018. The
main component of this increase resulted from the measurement of the fair value of the derivative warrant liabilities as at March 31, 2019, which resulted due to an increase to
the derivative warrant liabilities included in the statement of financial position of $2,055 and a corresponding loss to change in fair value of warrant liabilities, included in
financial income.
Financial expenses increased by $4,743 to $6,551 for the year ended March 31, 2019 from financial expenses of $1,808 for the year ended March 31, 2018. The main
component of this increase relates to the measurement of the fair value of the derivative warrant liabilities as at March 31, 2019. This increase was offset by a decrease of $481
in derivative warrant liability-related transaction costs, by foreign exchange gain of $311 as well as an increase in interest income of $403.
Two separate derivative warrant liabilities are included in the statement of financial position as at March 31, 2019, compared to one derivative warrant liability as at March
31, 2018. These derivative warrant liabilities stem from the financing transactions that took place in May 2018 and December 2017. The derivative warrant liabilities are re-
measured at each reporting date using the Black-Scholes option pricing model. The valuations are driven by the fluctuation in our common stock price resulting in an increased
or decreased loss or gain related to the change in fair value of the warrant liabilities and increasing or decreasing the corresponding liability in the statement of financial
position.
- 51 -
Selected Quarterly Financial Data
Net loss
Add (deduct):
Depreciation and amortization
Stock based compensation
Legal settlement expected to be paid via common shares
Financial (income) expense
Non-IFRS operating loss
March 31,
2019
$
December 31,
2018
$
September 30,
2018
$
(16,806)
731
128
990
2,862
(12,095)
(4,610)
(22,729)
723
336
-
(6,100)
(9,651)
689
326
-
12,291
(9,423)
Basic and diluted net loss per share
(0.22)
(0.07)
(0.62)
Net loss
Add (deduct):
Depreciation and amortization
Stock based compensation
Financial (income) expense
Non-IFRS operating loss
Basic and diluted net loss per share
March 31,
2018
$
December 31,
2017
$
September 30,
2017
$
(8,140)
667
268
778
(6,427)
(0.32)
(6,079)
(4,507)
671
330
929
(4,149)
667
295
122
(3,423)
(0.40)
(0.31)
June 30,
2018
$
(7,421)
684
251
-
(2,502)
(8,988)
(0.23)
June 30,
2017
$
(2,778)
667
36
(21)
(2,096)
(0.19)
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 last four quarters as we established an administrative and finance team independent from Neptune and expanded
our business development and pre-commercialization activities. The increase in net loss, net loss per share in the fourth quarter of fiscal 2019 compared to the fourth quarter of
fiscal 2018 can primarily be explained by the costs incurred in CRO’s expenses associated with its TRILOGY Phase 3 clinical trial program. The increases in net loss from
quarter to quarter, in addition to the increased non-IFRS operating losses, are mainly due to the changes in fair value of the derivative warrant liabilities as well as variations in
foreign exchange gains or losses.
- 52 -
Liquidity and Capital Resources
Share Capital Structure
Our authorized share capital consists of an unlimited number of Class A, Class B, Class C, Class D and Class E shares, without par value. Issued and outstanding fully paid
shares, stock options, restricted shares units and warrants, were as follows for the periods ended:
Class A shares, voting, participating and without par value
Stock options granted and outstanding
May 2018 public offering of warrants exercisable at $1.31, until May 9, 2023
Public offering broker warrants May 2018 exercisable at $1.05 until May 9, 2023
December 2017 U.S. public offering of warrants exercisable at US$1.26, until December 27, 2022
December 2017 U.S. broker warrants exercisable at US$1.2625, until December 27, 2022
February 2017 public offering of warrants exercisable at $2.15, until February 21, 2022
2017 unsecured convertible debentures conversion option contingent warrants exercisable at $1.90, until February 21, 20201
Series 8 warrants exercisable at US$15.00, until December 3, 20182
Series 9 warrants exercisable at $13.30 until December 3, 2018
Total fully diluted shares
March 31,
2019
Number
outstanding
78,132,734
4,046,677
10,188,100
547,975
9,801,861
495,050
1,904,034
1,052,630
-
-
106,169,061
March 31,
2018
Number
outstanding
25,638,215
2,284,388
-
-
9,802,935
495,050
1,904,034
1,052,630
1,840,000
161,654
43,178,906
Comparison of Cash Flows and Financial Condition Between the Three Month and Year End Periods March 31, 2019 and 2018
Summary
As at March 31, 2019, cash and cash equivalents totaled $22,521 with a net decrease in cash and cash equivalents totaling $6,372 for the three-month period ended March
31, 2019 and sources of cash totaling $14,298 for the year ended March 31, 2019. This compares to $8,223 in total cash and cash equivalents as at March 31, 2018 with a net
decrease in cash and cash equivalents totaling $4,252 for the three-month period ended March 31, 2018 and a net decrease in cash and cash equivalents totaling $1,549 for the
year ended March 31, 2018.
Operating Activities
During the three months ended March 31, 2019 and March 31, 2018, our operating activities used cash of $10,330 and $4,362, respectively, and during the years ended
March 31, 2019 and March 31, 2018, our operating activities used cash of $32,476 and $12,519, respectively (see “Reconciliation of Net Loss to Non-IFRS Operating Loss”),
further modified by changes in working capital, excluding cash.
Investing Activities
During the three months ended March 31, 2019, our investing activities generated cash of $5,148 compared to a use of cash of $123 for the three months ended March 31,
2018. The significant increase in cash generated by investing activities during the three months ended March 31, 2019 resulted from our disposal of marketable securities due to
cash on hand following the financings in October 2018. Cash used by investing activities during the three-month period ended March 31, 2018 was due to the acquisition of
equipment of $128, acquisition of marketable securities of $26, offset by interest received of $31.
______________________________
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, 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.
2 Total of 18,400,000 warrants. In order to obtain one common share, 10 warrants must be exercised for a total amount of US$15.00.
- 53 -
During the year ended March 31, 2019, our investing activities used cash of $12,136 compared to a use of cash of $411 for the year ended March 31, 2018. The significant
increase in cash used by investing activities resulted from our investment in marketable securities. Additionally, cash used by investing activities during the year ended March
31, 2019 was due to the acquisition of equipment of $700, partially offset by interest received of $384. Cash used by investing activities during the year ended March 31, 2018
was due to the acquisition of equipment totaling $455, acquisition of marketable securities of $26, partially offset by interest received of $70.
Financing Activities
During the three months ended March 31, 2019, our financing activities used cash of $483 due primarily to the payment of transaction costs related to the public offerings.
For March 31, 2018 we used cash of $36.
During the year ended March 31, 2019, our financing activities generated cash of $58,862 mainly from the net proceeds of the public offerings of $57,892 and proceeds
from warrants exercised related to the May 2018 public offering (see “Derivative warrant liabilities”) of $1,011. During the year ended March 31, 2018, our financing activities
generated cash of $11,406 primarily to the net proceeds from a public offering of $11,065 and proceeds from warrants exercised of $384.
See basis of presentation for additional discussion of our financial condition, including the need for additional funds and the material uncertainty that casts substantial
doubt about our ability to continue as a going concern.
ATM Program
On February 14, 2019, we entered into an “at-the-market” (“ATM”) sales agreement with B. Riley FBR, Inc., pursuant to which our common shares may be sold from time
to time for aggregate gross proceeds of up to US $30 million, with sales only being made on the NASDAQ Stock Market. The common shares will be distributed at market
prices prevailing at the time of the sale and, as a result, prices may vary between purchasers and during the period of distribution. As at March 31, 2019, no securities have been
issued in relation to the ATM, and it remains our intent to use this facility to prepare for commercial launch. Costs incurred in connection to the ATM of $179 have been
included as deferred financing costs.
October 2018 Public Offering
On October 9, 2018, we closed a U.S. public offering of 16,600,000 common shares at a price of US$1.00 per share. In addition, the underwriters fully exercised their
over-allotment option to purchase 2,490,000 additional common shares at the same public offering price. This offering generated gross proceeds of $24.7 million (US$19.1
million), which resulted in net proceeds to us of $22.6 million (US$17.4 million) and a total of 19,090,000 common shares issued.
On October 23, 2018, we closed a Canadian public offering of 18,750,000 common shares at a price of $1.28 per share. In addition, the underwriters fully exercised their
over-allotment option to purchase 2,812,500 additional common shares at the same public offering price. This offering generated gross proceeds of $27.6 million, which resulted
in net proceeds to us of approximately $25.4 million and a total of 21,562,500 common shares issued.
May 2018 Public Offering
On May 9, 2018 we closed a Canadian public offering issuing 9,530,000 units of Acasti (“Units”) at a price of $1.05 per Unit for gross proceeds of $10 million. The Units
issued consist of 9,530,000 common shares and 9,530,000 Warrants. Each Warrant entitles the holder thereof to acquire one of our common shares at an exercise price of $1.31
at any time until May 9, 2023.
On May 14, 2018, the underwriters exercised their over-allotment option by purchasing an additional 1,429,500 units at a price of $1.05 per Unit, for additional gross
proceeds of $1.5 million. The units issued consist of 1,429,500 common shares and 1,429,500 warrants. Each Warrant entitles the holder thereof to acquire one of our common
shares at an exercise price of $1.31 at any time until May 9, 2023.
The warrant component of these Units are Derivative Warrant Liabilities for accounting purposes due to the warrant agreement, which contains certain contingent
provisions that allow for cash settlement. The proceeds of the offering are required to be split between the Derivative Warrant Liabilities and the equity-classified common
shares at the time of issuance of the Units. The fair value of the Derivative Warrant Liabilities at the time of issuance was determined to be $4.3 million and the residual of the
proceeds of $6.2 million was allocated to the Common Shares. Issuance costs related to this transaction totaled approximately $1.8 million and have been allocated between the
Derivative Warrant Liabilities and Common shares based on relative value. Resulting from this allocation, $0.7 million has been allocated to the Derivative Warrant Liability
and is recognized in finance costs in the Statements of Earnings and Comprehensive Loss, whereas the remaining portion of $1.1 million in issuance costs was allocated to the
common shares and recognized as a reduction to share capital, in the Statements of Financial Position.
- 54 -
The weighted average fair value of the 2018 Warrants issued in May 2018 was determined to be $0.39 per warrant. Changes in the fair value of the 2018 Warrants are
recognized in finance expense.
As part of the May financing, we also issued broker warrants to purchase up to 547,975 Common Shares. Each broker warrant entitles the holder thereof to acquire one of
our common shares at an exercise price of $1.05, at any time until May 9, 2023. The broker warrants are considered for compensation to non-employees under IFRS 2, stock-
based compensation, and are accounted for at fair value at issuance date and not subsequently revalued.
Financial Position
The following table details the significant changes to the statements of financial position as at March 31, 2019 compared to the prior fiscal period end at March 31, 2018:
Accounts
Cash and cash equivalents
Marketable securities – current and long term
Receivable
Prepaid expenses
Other Asset – current and long term
Deferred financing costs
Equipment
Intangible asset
Trade and other payables
Derivative warrant liabilities
Unsecured convertible debentures
Increase
(Decrease)
14,298
11,866
857
709
(37)
179
(8)
(2,322)
11,549
9,837
205
Comments
See cash flow statement
See cash flow statement
Timing of receipts
Advancement of contracts
Usage of Krill Oil supply
Equity transactions
Acquisition of equipment and depreciation
Amortization
Increased expenses and accruals
Issuance of derivative warrants and change in fair value
Accretion of interest
See the statement of changes in equity in our financial statements for details of changes to the equity accounts since March 31, 2019.
Treasury Operations
Our treasury policy is to invest cash that is not required immediately into instruments with an investment strategy based on capital preservation. Cash equivalents and
marketable securities are primarily made in guaranteed investment certificates (“GICs”), term deposits and high-interest savings accounts, which are issued and held with
Canadian chartered banks; high rated promissory notes issued by government bodies and commercial paper. We hold cash denominated in both US and CAD dollars. Funds
received in US dollars from the equity private placement are invested as per our treasury policy in US dollar investments and converted to CAD dollars as appropriate to fulfill
operational requirements and funding.
Derivative warrant liabilities
The 2018 Warrants issued as part of our May 2018 public offering were recognized as Derivative Warrant Liabilities with a fair value of $4,272. As of March 31, 2019, the
Derivative Warrant Liabilities for the 2018 Warrants totaled $8,246, which represents the fair value of these warrants. The weighted average fair value of the 2018 Warrants
issued was determined to be $0.39 per warrant at inception and approximately $0.81 per 2018 Warrant as at March 31, 2019.
On December 27, 2017, warrants were issued as part of our U.S. public offering and recognized as Derivative Warrant Liabilities with a fair value of $5,873 (“2017
Warrants”). The 2017 Warrants are Derivative Warrant Liabilities for accounting purposes due to the currency of the exercise price (US$) being different from our Canadian
dollar functional currency. The fair value of the 2017 Warrants as of March 31, 2019, totaled $8,017 which represents the fair value of these warrants. The fair value of the 2017
Warrants was determined to be $0.60 per warrant upon issuance and approximately $0.82 per warrant as of March 31, 2019.
As of March 31, 2019, the fair value of the Derivative Warrant Liabilities issued as part of our Series 8 December 2013 securities offering was nil as the warrants expired
December 3, 2018.
- 55 -
The increase in the fair value of both existing derivative warrant liabilities as at March 31, 2019 is due to the increase in our share price and the dilution factor, and the
impact within the valuation model.
March 31, 2019
December 31, 2018
September 30, 2018
June 30, 2018
March 31, 2018
Warrant liabilities
issued May 2018
Warrant liabilities issued
December 27, 2017
Warrant liabilities issued
December 3, 2013
$
$
$
$
0.81 $
0.68 $
0.96 $
0.36 $
- $
Fair value per shares issuable
0.82
0.66
0.95
0.36
0.65
-
-
-
-
-
During October 2018, 771,400 - 2018 Warrants were exercised for one of our common shares at an exercise price of $1.31 for aggregate gross proceeds of approximately
$1.0 million. In addition, 4,455 2017 Warrants were exercised in a cashless manner to acquire 1,074 of our common shares. A total of 772,474 common shares were issued as a
result of 775,855 warrants exercised.
Contractual Obligations, Off-Balance-Sheet Arrangements and Commitments
As at March 31, 2019, our liabilities total $34,509, of which $18,426 is due within twelve months, $16,263 relates to Derivative Warrant Liabilities that will likely be
settled by issuing common shares in exchange for proceeds equal to the strike price of the instrument, and $1,817 of outstanding unsecured convertible debentures. The
unsecured convertible debentures may be prepaid. 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.
We also entered into a contract to purchase production equipment to be used in the manufacturing of the clinical and future commercial supply of CaPre.
A summary of the contractual obligations at March 31, 2019, is as follows:
Trade, other payables and due to related party
Lease
Unsecured convertible debentures
Total
Total contractual
Carrying value
$
cash flows
$
1 year or less
$
16,429
79
1,817
18,325
16,429
79
1,817
18,325
16,429
79
1,817
18,325
1 to 3 years
$
-
-
-
-
Research and development contracts and contract research organizations agreements
We utilize CMOs for the development and production of clinical materials and research organizations to perform services related to our clinical trials. Pursuant to the
agreements with these contract manufacturing and contract research organizations, we have either the right to terminate the agreements without penalties or under certain
penalty conditions. For agreements which contain penalty conditions, we would be required to pay penalties of approximately $109.
Lease
During fiscal year 2018, we entered into a lease agreement for our research and development and quality control laboratory facility located in Sherbrooke, Québec,
resulting in a commitment of $79 over the remaining lease term, which is committed in the next year.
Contingencies
We evaluate contingencies on an ongoing basis and establishes loss provisions for matters in which losses are probable and the amount of the loss can be reasonably
estimated.
- 56 -
On May 10, 2019 we announced the settlement regarding legal claims made by our former CEO with respect to the termination of his employment. Pursuant to the
settlement agreement, we have agreed to issue 900,000 common shares at $1.10 per share to the former CEO. In addition, we have agreed to reimburse the former CEO for
legal fees of $64. Furthermore, pursuant to the settlement agreement, we received a full and final release from the former CEO on all procedures in connection with the
termination of his employment. This settlement has been accrued as at March 31, 2019 and the expense of $1,054 is included as part of general and administrative expenses.
Related Party Transactions
We were charged by Neptune, our former parent company, for the purchase of research supplies and for certain costs incurred by Neptune for our benefit as follows:
Research and development expenses
Supplies and incremental costs
Shared service agreement
Total
General and administrative expenses
Supplies and incremental costs
Shared service agreement
Total
Total related parties expenses
March 31,
2019
$
March 31,
2018
$
Thirteen-
months ended
March 31,
2017
$
Month
ended
March 31,
2017
$
Twelve-months
ended
February 28,
2017
$
-
-
-
211
34
245
245
7
20
27
239
121
360
387
-
60
60
293
325
618
678
-
1
1
16
25
41
42
-
59
59
277
300
577
636
Where Neptune incurs specific incremental costs for our benefit, it charges those amounts directly. Neptune provides us with the services of personnel for certain
administrative work as part of a shared service agreement. The employees’ salaries and benefits are charged proportionally to the time allocation agreed upon within the shared
service agreement. Effective September 30, 2017, the laboratory support, the corporate affairs and the public company reporting services previously provided by Neptune as
part of the shared service agreement were discontinued. We are now incurring incremental costs and expects to do so in the future, partially offset by reduced shared service
fees. The account payable to Neptune amounted to $2 at March 31, 2019, $44 at March 31, 2018 and $12 at March 31, 2017, is non-interest bearing and has no specified
maturity date. 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 it not receive these services or benefits through the shared resources of Neptune.
During the three-months and year ended March 31, 2019, we recognized expenses of $47 and $245, respectively in general and administrative expenses in relation to
supplies and incremental costs, compared to $80 and $387, respectively, for the three-month and year ended March 31, 2018. As the research and development and quality
control laboratory facility is now completely independent of the Neptune facility, there were no related party charges for research and development as at March 31, 2019.
Historically, Neptune has provided us with the raw krill oil needed to produce CaPre for our clinical programs, including all of the raw krill oil projected as needed for our
Phase 3 clinical study program. However, Neptune discontinued its krill oil production and sold its krill oil inventory to Aker on August 7, 2017. We are continually evaluating
alternative suppliers of raw krill oil. At March 31, 2019, a reserve of raw krill oil was still stored at Neptune’s facility.
Our key management personnel are our officers and the members of our Board of Directors. They control in the aggregate less than 1% of our total voting shares (1% at
March 31, 2018). See note 7 to the financial statements for disclosures of key management personnel compensation.
Use of estimates and measurement of uncertainty
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.
- 57 -
Estimates are based on management’s 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 the following:
·
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 its assets and discharge its 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 the following:
· Measurement of derivative warrant liabilities and stock-based compensation.
Also, management uses judgment to determine which research and development expenses qualify for research and development tax credits and in what amounts. We
recognize the tax credits once it we have had 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
Derivative warrant liabilities
The warrants forming part of the Units issued from the May 2018 public offering are derivative liabilities for accounting purposes given to the fact that the warrant
indenture contains certain contingent provisions that allow for cash settlement. The warrants forming part of the Units issued from the December 2017 and December 2013
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 17 of the 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 grant and is expensed over the award’s 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.
FINANCIAL INSTRUMENTS
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 risks relating to cash, cash
equivalents and marketable securities, 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 our credit exposure at the reporting date.
- 58 -
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 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 which were part of US dollar financings continue to be invested as
short-term investments in the US dollar.
Furthermore, a portion of our cash and cash equivalents and marketable securities are denominated in US dollars, further exposing us to fluctuations in the value of the US
dollar in relation to the Canadian dollar presented in Note 21 of the financial statements.
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.
Our exposure to interest rate risk as at March 31, 2019 and March 31, 2018 is as follows:
Cash and cash equivalents
Marketable Securities
Unsecured convertible debentures
Short-term fixed interest rate
Short-term fixed interest rate
Short-term fixed interest rate
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.
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 our capital
structure and financial leverage, as outlined in Note 21 to the financial statements. We also manage liquidity risk by continuously monitoring actual and projected cash flows.
The 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 the liquidity and capital resources of this MD&A.
Future accounting changes:
The following new standards, and amendments to standards and interpretations, are not yet effective for the period ended March 31, 2019, and have not been applied in
preparing these financial statements.
New standards and interpretations not yet adopted:
Leases – IFRS 16
IFRS 16, Leases (“IFRS 16”) In January 2016, the IASB issued IFRS 16, a new standard that replaces IAS 17, Leases. IFRS 16 is a major revision of the way in which
companies account for leases and will no longer permit off balance sheet leases. Adoption of IFRS 16 is mandatory and will be effective in our fiscal year beginning on April 1,
2019. We are assessing the impact of adoption of IFRS 16, and currently there is only one lease that will be impacted by this new standard and the impact is expected to be
minimal.
- 59 -
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 or Residence of
each Director
Principal Occupation
First
Year as
Director
Number of Common
Shares Beneficially
Owned or Controlled or
Directed by Each Director (1)
Roderick Carter
California, United States
Chairman of the Board
Jean-Marie (John) Canan
Florida, United States
Jan D’Alvise
California, United States
Donald Olds
Quebec, Canada
Principal Aquila Life Sciences LLC
Corporate Director
President and CEO of Acasti
President and CEO of NEOMED Institute
2015
2016
2016
2018
-
107,500
52,500
38,000
______________________________
Notes:
(1) Based on information publicly available on SEDI.
The following is a brief biography of our current 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 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.
Jan D’Alvise (also our President and CEO)
Ms. D’Alvise has extensive experience in diagnostics, medical devices, pharmaceuticals and drug discovery research tools. Until 2016, Ms. D’Alvise 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. D’Alvise 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. D’Alvise built both companies from technology concept through to successful regulatory
approvals, product introduction and sustainable revenue growth. Prior to 1995, Ms. D’Alvise 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, (Syntex’s clinical diagnostics division), and began her career with Diagnostic Products
Corporation. Ms. D’Alvise 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. D’Alvise 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.
- 60 -
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. 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.
Donald Olds
Mr. Olds was until recently President and Chief Executive Officer of the NEOMED Institute, an R&D organization dedicated to advancing Canadian research discoveries
to commercial success. Prior to NEOMED, he was the Chief Operating Officer of Telesta Therapeutics Inc., a TSX-listed biotechnology company, where he was responsible for
finance and investor relations, manufacturing operations, business development, human resources and strategy. In 2016, he led the successful sale of Telesta to a larger public
biotechnology company. Prior to Telesta, he was President and Chief Executive Officer of Presagia Corp., and Chief Financial Officer and Chief Operating Officer of Aegera
Therapeutics, where he was responsible for clinical operations, business development, finance, and mergers and acquisitions. At both Telesta and Aegera, Mr. Olds was
responsible for raising more than $100 million in equity financing and leading regional and global licensing transactions with life sciences companies. Mr. Olds is currently
Director of Goodfood Market Corp, Oxfam Quebec and Director of Presagia Corp. He has extensive past corporate governance experience serving on the boards of private and
public for-profit and not-for-profit organizations. He holds an MBA (Finance & Strategy) and M.Sc. (Renewable Resources) from McGill University.
The following are brief biographies of our senior managers, other than our President and Chief Financial Officer, Jan D’ Alvise, whose biography appears further above:
Dr. Pierre Lemieux – Chief Operating Officer and Chief Scientific Officer (COO and CSO)
Dr. Lemieux has been our Chief Operating Officer since April 12, 2010 and our Chief Scientific Officer since June 2018. Previously, Mr. Lemieux was CEO, Co-Founder
and Chairman of BiolActis Inc. which he sold in 2009 to interests affiliated with the Nestlé multinational group. Mr. Lemieux joined Suprateck Pharma in 1999 as Director and
Vice-President involved in the development of formulations for gene therapy on behalf of Rhone-Poulenc Rorer and Genzyme, which today are under the Sanofi banner. Prior
to this, Mr. Lemieux was involved in the development of cardiovascular products at Angiotech Pharmaceuticals. Mr. Lemieux has a Ph.D. in biochemistry from Université
Laval (Québec). He holds more than 16 patents and has authored over 50 publications. Mr. Lemieux’s research was conducted at Université Laval as well as at the anti-cancer
center Paul Papin D’Angers (France) and the University of Nottingham (England). His research focused on ovarian cancer and its treatment with monoclonal antibodies used to
target cancer drugs. After completing his graduate studies, Mr. Lemieux joined the Oncology division of the Center for Health Research, University of Texas (U.S.). He
obtained a postdoctoral fellowship from the Susan G. Komen Foundation (Breast Cancer). Mr. Lemieux has served on the boards of BioQuébec, Montreal in vivo and
PharmaBio Development.
Mr. Brian Groch – Chief Commercial Officer (CCO)
Mr. Groch has been our Chief Commercial Officer since June 4, 2018. Mr. Groch brings over 25 years of senior experience in the healthcare and life science industries,
including product commercialization, developing and executing global sales strategies, business development, and operations. Most recently, Mr. Groch served as Executive
Vice President and Chief Commercial Officer at Veru Inc., a urology, oncology and female health products company, where he was responsible for leading the development
and execution of the company’s long-term commercial strategy. Under his leadership, Veru experienced rapid growth in sales of the company’s women’s health product. Mr.
Groch also served as Chief Commercial Officer for Telesta Therapeutics, where he led the development and implementation of the global commercial strategy. Previously, Mr.
Groch served as Vice President of Commercial Operations and Market Access for Horizon Therapeutics, where he oversaw global operations including the integration of two
acquisitions valued over $1.5 billion. Mr. Groch has also served as CEO and President of Exsto Therapeutics, Head of Market Access for Dendreon, and Director of Health
Policy for Phadia. He has held senior management roles with Novartis and Merck & Co. He holds an M.S. in Healthcare Administration and Marketing from Central Michigan
University, as well as a B.S. in Physiology from Central Michigan University.
Jean-François Boily – Vice-President, Finance
Mr. Boily has been our Vice-President of Finance since September 24, 2018. Prior to joining Acasti, Mr. Boily served as a Director of Finance & Information Technology
(IT) at Innovaderm Research Inc., a large North American contract research organization (CRO) specialized in dermatology. At Innovaderm Mr. Boily worked closely with the
President and Chief Medical Officer and founder, where Mr. Boily was responsible for all aspects of Finance and IT. Mr. Boily undertook a major financial, IT and growth
mandate where Mr. Boily increased revenues and profits over 25%. Prior to that, Mr. Boily was a Director of Finance at Teva Canada, a generic drug products manufacturer,
where he oversaw manufacturing of generics, managing branded product launches and clinical R&D activities. At Teva, Mr. Boily worked closely with the CFO, where he had
oversight of four production sites that generated more than four billion doses. Most recently, Mr. Boily worked as a consultant and Vice President of Finance and IT for a
pharmaceutical start-up led by a US-based investor, where he helped raise seed capital in advance of a planned initial public offering in Canada and the US. Mr. Boily holds a
BS in Accounting from HEC Montreal and is a Chartered Public Accountant (CPA).
- 61 -
B.
Compensation
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, 2019,
the GHR committee retained compensation consulting services, including those led by The Sarkaria Group, 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 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 2019 executive compensation review, the
board and GHR committee set the following executive compensation program.
Use of Fixed and Variable Pay Components
Compensation of our named executive officers (“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, 2019, the following components were examined
by the GHR committee:
·
·
·
·
base salary;
short term incentive plan, consisting of a cash bonus;
long term incentive plan, consisting of stock options and equity incentive grants based on performance and/or time vesting conditions; and
other elements of compensation, consisting of group benefits and perquisites.
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 individual’s 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.
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Ms. D’Alvise, our CEO, is eligible for up to a 50% bonus of her annual base salary. Dr. Lemieux, our COO, and Mr. Groch, our CCO, are each eligible for up to a 40%
bonus of their annual base salary. Mr. Boily, our Vice-President, Finance, 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.
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 7,
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:
·
·
CEO — 2x then-current annual base salary
Other executives — 1x then-current annual base salary.
The value of an individual’s 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
individual’s 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 April 15, 2019. 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 option holders 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 participant’s 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.
- 63 -
In accordance with the stock option plan, all of an option holder’s 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.
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, director and/or consultant, 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 15% of our outstanding issued common shares as of April 9, 2019 may be granted by the board under the stock
option plan. As at April 9, 2019, there were 11,719,910 common shares reserved for issuance under the stock option plan. As of the date of this annual report, there were
600,081 options outstanding under the stock option plan.
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 and has been amended from time to time, including most recently on April 15, 2019.
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 may participate in the equity incentive plan. 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.
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.
- 64 -
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 the lower of (i) 1,953,318 common shares, and (ii) 15% of the issued and outstanding
common shares as of April 9, 2019, representing 11,719,910 common shares, which includes common shares issuable pursuant to options issued under our stock option plan.
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 $1,500 per fiscal year for eligible employees who participate
in the program. Other than matching contributions under the RRSP matching program (which amounts are disclosed in the column entitled “All Other Compensation” in the
summary compensation table below), we do not provide pension or retirement benefits to our executive officers or directors.
Other Benefits and Perquisites. Our executive employee benefit program also includes life, medical, dental and disability insurance. These benefits and perquisites are
designed to be competitive overall with equivalent positions in comparable organizations. We do not have a pension plan for employees.
Compensation Paid to Named Executive Officers
The following table sets forth the compensation information for the NEOs during the fiscal year ended March 31, 2019, the fiscal year ended March 31, 2018 and the fiscal
year ended March 31, 2017.
Name and
Principal
Position
Jan D’Alvise(4)
President and CEO
Pierre Lemieux
COO
Brian Groch(8)
CCO
Jean-François Boily(9)
VP Finance
Linda O’Keefe
Former CFO(12)
Period
ended
Salary
($)
March 31, 2019
March 31, 2018
March 31, 2017
March 31, 2019
March 31, 2018
March 31, 2017
March 31, 2019
498,332
431,902
365,072
261,018
253,680
275,819
295,681
March 31, 2019
103,821
March 31, 2019
March 31, 2018
March 31, 2017
269,762
327,199
114,183
Share-
Based
Awards
($)
Option-Based
Awards
($)(1) (2)
Annual
Incentive
Plans
($)
241,291(10)
183,500(6)
136,049(7)
99,298
71,155
49,000
88,864(11)
497,196
528,279
502,163
200,533
190,426
96,522
164,589
111,693
30,638
-
159,712
237,340
-
64,475(13)
39,897(14)
All Other
Compensation
($)
Total
Compensation
($)
-
-
-
-
1,500(3)
-
-
-
-
-
109,414
1,236,819
1,143,681
1,003,284
560,849
516,761
421,341
549,134
246,152
269,762
551,386
500,834
-
-
-
-
-
-
-
-
-
-
-
- 65 -
______________________________
Notes:
(1)
(2)
(3)
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 management’s best estimates, they involve inherent
uncertainties based on market conditions generally outside of our control.
The fair value of the option-based awards granted on July 2, 2018 in the fiscal year ended March 31, 2019 is $0.5486.
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 fiscal years ended March 31, 2019, March 31, 2018 and March 31, 2017.
(4) Ms. D’Alvise 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$380,000. In fiscal 2019, Ms. D’Alvise earned an annual base salary of US$394,398.
US$142,303 converted as at March 31, 2018, based on a closing exchange rate of US$1.00 = $1.2895.
US$102,300, converted as at March 31, 2017, based on a closing exchange rate of US1.00= $1.3299.
US$50,000 converted as at March 31, 2018, based on a closing exchange rate of US$1.00 = $1.2895.
(5)
(6)
(7)
(8) Mr. Groch was appointed our CCO on June 1, 2018. His employment agreement provides for payments in U.S. dollars with an annual base salary of US$280,000. In fiscal 2019, Mr. Groch earned an
annual base salary of US$225,346.
(9) Mr. Boily was appointed our VP Finance on September 24, 2018. His employment agreement provides for an annual base salary of $215,000.
(10) US$180,566 converted as at March 31, 2019, based on a closing exchange rate of US$1.00 = $1.3363.
(11) US$66,500 converted as at March 31, 2019, based on a closing exchange rate of US$1.00 = $1.3363.
(12) Ms. O’Keefe resigned as CFO effective October 26, 2018.
(13) US$50,000 converted as at March 31, 2018, based on a closing exchange rate of US$1.00 = $1.2895.
(14) US$30,000 converted as at March 31, 2017, based on a closing exchange rate of US$1.00 = $1.3299.
- 66 -
Outstanding Share-Based and Option-Based Awards
The following tables provide information about the number and value of the outstanding option-based awards held by the NEOs as of March 31, 2019. There are no share-
based awards outstanding as of the date of this annual report.
Name/Grant Date
Number of Securities
Underlying Unexercised
Options
(#)
Option Exercise Price
($)(1)
Option Expiration Date
Value of Unexercised
In-The-Money Options
($)(2)
Jan D’Alvise
July 2, 2018
June 14, 2017
May 12, 2016
Pierre Lemieux
July 2, 2018
June 14, 2017
February 24, 2017
May 30, 2016
June 1, 2015
October 20, 2014
Brian Groch
July 2, 2018
Jean-François Boily
September 21, 2018
______________________________
Notes:
906,248
430,000
525,000
365,515
155,000
50,000
31,400
16,900
7,500
300,000
200,000
0.77
1.77
1.56
0.77
1.77
1.65
1.99
4.50
6.50
0.77
0.78
July 2, 2028
June 14, 2027
May 12, 2023
July 2, 2028
June 14, 2027
February 24, 2027
May 29, 2023
June 1, 2022
October 19, 2019
July 2, 2028
September 21, 2028
525,624
--
--
211,999
--
--
--
--
--
174,000
114,000
(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 $1.35 of our common shares on the TSXV, as at closing on March 29, 2019.
The following table sets out the value of share-based, option-based, and warrant-based awards held by the NEOs that vested during the fiscal year ended March 31, 2019:
Name
Share-Based Awards
($)
Option-Based Awards
($)
Jan D’Alvise
Jean-François Boily
Pierre Lemieux
Brian Groch
Compensation of Directors
--
--
--
--
439,821
18,250
150,624
40,635
Our directors’ compensation consists of an annual fixed compensation of US$60,000 for the chairman of the board and US$30,000 for the other non-executive board
members. In addition, the chairperson of the audit committee and the chairperson of the governance and human resources committee receive additional compensation of
US$15,000 and US$10,000, respectively, while members of the audit committee and the governance and human resources committee receive additional compensation of
US$7,500 and US$5,000, respectively. The directors are also entitled to be reimbursed for travelling and other reasonable expenses properly incurred by them in attending
meetings of the board or any committee or in otherwise serving us, in accordance with our policy on travel and expenses.
- 67 -
Following their first election to our board of directors, non-executive directors are eligible to receive an initial equity grant of up to 150% of their annual cash retainer
worth of stock options vesting annually in equal installments over an 18-month period, subject to the other terms and conditions set forth under the heading “Stock Option
Plan”. In addition to their initial grant, non-executive directors are eligible to receive an annual equity-based award equal to 100% of their total annual cash retainer vesting
quarterly in equal installments over an 18-month period. These awards will be granted at the same time that we are performing our annual performance review for our
employees, subject to availability of common shares and subject to the terms and conditions described under the headings “Stock Purchase Plan” and “Equity Incentive Plan”.
The level of these awards will be consistent with equivalent awards in comparable companies obtained from the benchmark exercise and in accordance with the
recommendations obtained from our independent compensation consultant. The total compensation for our non-executive directors during fiscal year ended March 31, 2019 was
as follows:
Name
Fiscal Year Ended
March 31
Fees Earned
($)
Option-Based
Awards
($)(1)(2)
All Other
Compensation
($)(3)
Roderick N. Carter
Jean-Marie (John) Canan
Donald Olds
2019
2019
2019
85,291 (4)
58,778 (5)
36,657 (6)
80,377
60,283
50,000
--
--
--
Total
($)
165,668
119,061
86,657
______________________________
Notes:
(1)
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 management’s best estimates, they involve inherent
uncertainties based on market conditions generally outside of our control.
For the fiscal year ended on March 31, 2019, the fair market value of the July 2, 2018 option-based awards is based on a fair value of $ 0.51 per option granted.
(2)
The directors do not receive pension benefits or other non-equity based annual compensation.
(3)
(4)
Dr. Carter earned a director compensation of US$65,000.
(5) Mr. Canan earned a director compensation of US$45,000.
(6) Mr. Olds was appointed as a director on April 27, 2018 and earned a director compensation of US$27,885.
The following table provides information about the number and value of the outstanding share-based and option-based awards held by non-executive directors. There were
no share-based awards outstanding as of the date of this annual report.
Name/Grant Date
Roderick N. Carter
July 2, 2018
June 14, 2017
May 30, 2016
August 19, 2015
Jean-Marie (John) Canan
July 2, 2018
June 14, 2017
February 24, 2017
Donald Olds
July 2, 2018
______________________________
Notes:
Number of Securities
Underlying Unexercised
Options
(#)
Option Exercise Price
($)(1)
Option Expiration Date
Value of Unexercised
In-The-Money Options
($)(2)
80,377
51,000
200,000
10,000
60,283
29,000
50,000
50,000
0.77
1.77
1.99
4.80
0.77
1.77
1.65
0.77
July 2, 2028
June 14, 2027
May 29, 2023
August 19, 2022
July 2, 2028
June 14, 2027
February 24, 2027
July 2, 2028
46,619
--
--
--
34,964
--
--
29,000
(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 $1.35 for our common shares on the TSXV, as at closing on March 29, 2019.
- 68 -
C.
Board Practices
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 Mr. Olds 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 Ms. D’Alvise is not independent within the meaning of NI 52-110 and NASDAQ given that she is our President and CEO.
During the fiscal year ended March 31, 2019, the board of directors held 14 meetings. All directors were in attendance for each regularly scheduled quarterly and annual
meeting of the Board.
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.
- 69 -
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 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 year’s
annual meeting of shareholders. Recommendations must include the candidate’s name, contact information and a statement of the candidate’s 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.
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.
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The GHR committee is composed of independent members within the meaning of NI 52-110 and NASDAQ Stock Exchange rules, namely Dr. Carter, Mr. Canan and Mr.
Olds.
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.
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 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 management’s
discussion and analysis;
assessing our financial and accounting personnel;
assessing our accounting policies;
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, 2019, the audit committee was composed of Mr. Canan, as chairperson, Dr. Carter and Mr. Olds. Each of Mr.
Canan, Dr. Carter and Mr. Olds is “financially literate” and “independent” within the meaning of NI 52-110 and the Exchange Act. As of the date of this annual report, the
composition of the audit committee remains the same as at March 31, 2019.
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, 2019, the GHR committee was composed of the
following members, each of whom is independent: Dr. Carter, Mr. Canan and Mr. Olds. 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.
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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 CEO’s salary is based on comparable market
consideration and the GHR committee’s 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.
D.
Employees
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, 2019, we had 28 full-time employees. 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.
E.
Share Ownership
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
Roderick N. Carter
Jean-Marie (John) Canan
Donald Olds
Jan D’Alvise
Pierre Lemieux
Brian Groch
Jean-François Boily
Common shares beneficially owned
as of March 31, 2019
Percentage of total issued and
outstanding common shares
as of March 31, 2019(1)
-
107,500
38,000
52,500
7,000
-
-
-
*
*
*
*
-
-
(1)
*
Based on 78,132,734 common shares outstanding as of the date of this annual report.
Less than 1%.
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
A.
Major Shareholders
To the best of our knowledge, there are no 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/A filed by Mr. Haywood with the U.S. Securities and Exchange Commission (the “Commission”) on February 13, 2019,
beneficially owns 7,396,906 of our common shares, representing approximately 9.2% of our issued and outstanding common shares.
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All common shares are common shares with the same voting rights. Based on the most recent information received from our registrar and transfer agent, Computershare
Investor Services Inc., as of the date of this annual report, there are approximately 9 registered holders (including The Depository Trust Company) of our common shares
resident in the United States (approximately 37.5% 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.
Financial Statements and Other Financial Information
Financial Statements
See “Item 17. Financial Statements” for our audited financial statements.
Legal Proceedings
Due to the fact that a portion of our intellectual property rights are licensed to us by Neptune/Aker, we rely on Neptune/Aker to protect a certain of the intellectual property
rights that we use under our license agreement with Neptune/Aker. Neptune/Aker are engaged in a number of legal actions related to their intellectual property.
On May 10, 2019 the we announced the settlement regarding legal claims made by our former chief executive officer (“CEO”) with respect to the termination of his
employment. Pursuant to the settlement agreement, Acasti agreed to issue 900,000 common shares to the former CEO and also agreed to reimburse the former CEO for nominal
legal fees. Furthermore, pursuant to the settlement agreement, the Acasti received a full and final release from the former CEO on all proceedings in connection with the
termination of his employment.
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
Not applicable except for Item 9.A.4 and Item 9.C.
Since March 31, 2011, the common shares have been listed on the TSX-V under the ticker symbol ACST. Since January 7, 2013, the common shares have been listed on
the NASDAQ Stock Market under the ticker symbol ACST.
Item 10. Additional Information
A.
Share Capital
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.
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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 director’s 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 director’s
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.
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, 2019, there were:
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
a total of 78,132,734 common shares issued and outstanding and no preferred shares issued and outstanding,
4,046,677 options to purchase common shares issued and outstanding, at a weighted average exercise price of $1.25 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 1,052,630 common shares (the debentures are convertible into up to 1,052,630 common shares at any time by the holders 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, in which case the applicable pro rata share
of the contingent warrants will be exercisable for the remaining term of the convertible debentures at a fixed price of $1.90 per common share),
warrants issued in connection with our February 2017 public offering to purchase up to 1,904,034 common shares at an exercise price of $2.15 per common share,
broker warrants issued in connection with our December 2017 public offering to purchase up to 495,050 common shares at an exercise price of US$1.26 per
common share,
warrants issued in connection with our December 2017 public offering to purchase up to 9,801,861 common shares at an exercise price of US$1.26 per common
share.
warrants issued in connection with our May 2018 public offering to purchase up to 10,188,100 common shares at an exercise price of $1.31 per common share.
broker warrants issued in connection with our May 2018 public offering to purchase up to 547,975 common shares at an exercise price of $1.05 per common share
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.
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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
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.
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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.
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:
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
Conversion Ratio
= 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 D 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 D 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
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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.
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:
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
Conversion Ratio
=
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
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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.
C.
Material Contracts
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 and
other than the warrant agency agreement relating to the warrants that we issued in connection with our public offering of units in December 2017 and the indenture relating to
the warrants that we issued in connection with our public offering of units in May 2018.
D.
Exchange Controls
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.
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.
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E.
Taxation
The following is a summary of certain U.S. federal income tax considerations arising from and relating to the acquisition, ownership, and disposition of our common shares to a
U.S. Holder (as defined below) 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 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), in each case, as in effect as of the date of this report. 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. 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 equity securities
(by vote or value); 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.
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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 non-U.S. 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 discussion under “—Passive Foreign Investment Company Rules” below, 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. Holder’s 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).
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 if 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 be a PFIC in the current taxable year, or 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 discussion under “—Passive Foreign Investment Company Rules” below, 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. Holder’s 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.
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Passive Foreign Investment Company Rules
If we are or become a PFIC, the preceding sections of this summary may not describe the U.S. federal income tax consequences to U.S. Holders of the acquisition, ownership,
and disposition of our common shares.
Passive Foreign Investment Company Status.
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 generally 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.
As described above, PFIC status of a non-U.S. corporation for a taxable year depends on the relative values of certain categories of assets and the relative amount of certain
kinds of income. Therefore, our status as a PFIC for any given taxable year depends upon the financial results for such year and upon relative valuations, which are subject to
change and beyond our ability to predict or control. Based on our most recent financial statements and projections and given uncertainty regarding the composition of our future
income and assets, there is a significant risk that we may have been classified as a PFIC for the 2019 taxable year and may be classified as a PFIC for our current taxable year
and possibly subsequent years. However, PFIC status is fundamentally factual in nature, depends on the application of complex U.S. federal income tax rules (which are subject
to differing interpretations), generally cannot be determined until the close of the taxable year in question and is determined annually. Accordingly, there can be no assurance
that we will not be a PFIC in our current taxable year or subsequent years. The PFIC rules are complex, and each U.S. Holder should consult its tax advisor regarding the
application of the PFIC rules to us.
Default PFIC Rules Under Section 1291 of the Code.
Generally, if we are or have been treated as a PFIC for any taxable year during a U.S. Holder’s holding period of common shares, subject to the special rules described below
applicable to a U.S. Holder who makes a Mark-to-Market Election or a QEF Election (each as defined below), any “excess distribution” with respect to the common shares
would be allocated ratably over the U.S. Holder’s holding period. The amounts allocated to the taxable year of the excess distribution and to 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. Holder’s holding period, whichever is shorter. In addition, dividends generally will not be qualified dividend income if we are a PFIC
in the taxable year of payment or the preceding year.
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 ratably over the U.S. Holder’s holding period and subject to taxation in the same manner as described in the preceding
paragraph, and would not be eligible for the preferential long-term capital gains rate.
Certain elections (including the Mark-to-Market Election and the QEF Election, as defined and discussed below) may sometimes be used to mitigate the adverse impact of the
PFIC rules on U.S. Holders, but these elections may accelerate the recognition of taxable income and have other adverse results.
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Each current or prospective U.S. Holder should consult its own tax advisor regarding potential status of us as a PFIC, the possible effect of the PFIC rules to such
holder in their particular circumstances, information reporting required if we were treated as a PFIC and 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.
QEF Election.
A U.S. Holder of common shares in a PFIC generally would not be subject to the PFIC rules discussed above if the U.S. Holder had made a timely and effective election (a
“QEF Election”) to treat us as a “qualified electing fund” (a “QEF”). Instead, such U.S. Holder would be subject to U.S. federal income tax on its pro rata share of our (i) net
capital gain, which would be taxed as long-term capital gain to such U.S. Holder, and (ii) ordinary earnings, which would be taxed as ordinary income to such U.S. Holder, in
each case regardless of whether such amounts are actually distributed to such U.S. Holder. However, a U.S. Holder that makes a QEF Election may, subject to certain
limitations, elect to defer payment of current U.S. federal income tax on such amounts, subject to an interest charge. If such U.S. Holder is not a corporation, any such interest
paid will be treated as “personal interest,” which is not deductible.
A U.S. Holder that makes a timely and effective QEF Election generally (a) may receive a tax-free distribution from us to the extent that such distribution represents our
“earnings and profits” that were previously included in income by such U.S. Holder because of such QEF Election and (b) will adjust such U.S. Holder’s tax basis in the
common shares to reflect the amount included in income or allowed as a tax-free distribution because of such QEF Election. In addition, for U.S. federal income tax purposes, a
U.S. Holder that makes a timely QEF Election generally will recognize capital gain or loss on the sale or other taxable disposition of the common shares.
A QEF Election will be treated as “timely” if such QEF Election is made for the first taxable year in the U.S. Holder’s holding period for the common shares in which we are a
PFIC. A U.S. Holder may make a timely QEF election by filing the appropriate QEF Election documents at the time such U.S. Holder files a U.S. federal income tax return for
such first year. If a U.S. Holder makes a QEF Election after the first taxable year in the U.S. Holder’s holding period for the common shares in which we are a PFIC, then, in
addition to filing the QEF Election documents, a U.S. Holder may elect to recognize gain (which will be taxed under the rules discussed under “—Default PFIC Rules Under
Section 1291 of the Code”) as if the common shares were sold on the qualification date. The “qualification date” is the first day of the first taxable year in which we are a QEF
with respect to such U.S. Holder. The election to recognize such gain can only be made if such U.S. Holder’s holding period for the common shares includes the qualification
date. By electing to recognize such gain, such U.S. Holder will be deemed to have made a timely QEF Election. In addition, under very limited circumstances, it is possible that
a U.S. Holder might make a retroactive QEF Election if such U.S. Holder failed to file the QEF Election documents in a timely manner. If a U.S. Holder fails to make a QEF
Election for the first taxable year in the U.S. Holder’s holding period for the common shares in which we are a PFIC and does not elect to recognize gain as if the common
shares were sold on the qualification date, such holder will not be treated as having made a “timely” QEF election and will continue to be subject to the special adverse taxation
rules discussed above under “—Default PFIC Rules Under Section 1291 of the Code”.
A QEF Election will apply to the taxable year for which such QEF election is made and to all subsequent taxable years, unless such QEF Election is invalidated or terminated or
the IRS consents to revocation of such QEF Election. If a U.S. Holder makes a QEF Election and, in a subsequent taxable year, we cease to be a PFIC, the QEF Election will
remain in effect (although it will not be applicable) during those taxable years in which we are not a PFIC. Accordingly, if we become a PFIC in another subsequent taxable
year, the QEF Election will be effective and the U.S. Holder will be subject to the rules described above during any such subsequent taxable year in which we qualify as a PFIC.
A U.S. Holder cannot make and maintain a valid QEF Election unless we provide certain U.S. tax information necessary to make such an election. On an annual basis, we
intend to use commercially reasonable efforts to make available to U.S. Holders, upon their written request (a) timely information as to our status as a PFIC, and (b) for each
year in which we are a PFIC, information and documentation that a U.S. Holder making a QEF Election with respect to us is required to obtain for U.S. federal income tax
purposes. Each U.S. Holder should consult its own tax advisor regarding the availability of, and procedure for making, a QEF Election with respect to us.
Mark-to-Market Election.
A U.S. Holder of common shares in a PFIC would not be subject to the PFIC rules discussed above under “—Default PFIC Rules Under Section 1291 of the Code” if the U.S.
Holder had made a timely and effective election to mark the PFIC common shares to market (a “Mark-to-Market Election”).
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A U.S. Holder may make a Mark-to-Market Election with respect to the common shares only if such shares are marketable stock. Such shares generally will be “marketable
stock” if they are regularly traded on a “qualified exchange,” which is defined as (a) a national securities exchange that is registered with the Securities and Exchange
Commission, (b) the national market system established pursuant to section 11A of the Exchange Act of 1934, or (c) a non-U.S. securities exchange that is regulated or
supervised by a governmental authority of the country in which the market is located, provided that (i) such non-U.S. exchange has trading volume, listing, financial disclosure,
surveillance, and other requirements, and the laws of the country in which such non-U.S. exchange is located, together with the rules of such non-U.S. exchange, ensure that
such requirements are actually enforced and (ii) the rules of such non-U.S. exchange ensure active trading of listed stocks. Our common shares will generally be treated as
“regularly traded” in any calendar year in which more than a de minimis quantity of common shares is traded on a qualified exchange for at least 15 days during each calendar
quarter. Each U.S. Holder should consult its own tax advisor with respect to the availability of a Mark-to-Market Election with respect to the common shares.
In general, a U.S. Holder that makes a timely Mark-to-Market Election with respect to the common shares will include in ordinary income, for each taxable year in which we are
a PFIC, an amount equal to the excess, if any, of (a) the fair market value of the common shares as of the close of such taxable year over (b) such U.S. Holder’s tax basis in such
shares. A U.S. Holder that makes a Mark-to-Market Election will be allowed a deduction in an amount equal to the lesser of (a) the excess, if any, of (i) such U.S. Holder’s
adjusted tax basis in the common shares over (ii) the fair market value of such shares as of the close of such taxable year or (b) the excess, if any, of (i) the amount included in
ordinary income because of such Mark-to-Market Election for prior taxable years over (ii) the amount allowed as a deduction because of such Mark-to-Market Election for
prior taxable years. If a U.S. Holder makes a Mark-to-Market Election after the first taxable year in which we are a PFIC and such U.S. Holder has not made a timely QEF
Election with respect to us, the PFIC rules described above under “—Default PFIC Rules Under Section 1291 of the Code” will apply to certain dispositions of, and distributions
on, the common shares, and the U.S. Holder’s mark-to-market income for the year of the election. If we were to cease being a PFIC, a U.S. Holder that marked its common
shares to market would not include mark-to-market gain or loss with respect to its common shares for any taxable year that we were not a PFIC.
A U.S. Holder that makes a Mark-to-Market Election generally will also adjust such U.S. Holder’s tax basis in his common shares to reflect the amount included in gross
income or allowed as a deduction because of such Mark-to-Market Election. In addition, upon a sale or other taxable disposition of the common shares subject to a Mark-to-
Market Election, any gain or loss on such disposition will be ordinary income or loss (to the extent that such loss does not to exceed the excess, if any, of (a) the amount
included in ordinary income because of such Mark-to-Market Election for prior taxable years over (b) the amount allowed as a deduction because of such Mark-to-Market
Election for prior taxable years). A Mark-to-Market Election applies to the taxable year in which such Mark-to-Market Election is made and to each subsequent taxable year,
unless the common shares cease to be “marketable stock” or the IRS consents to revocation of such election. Each U.S. Holder should consult its own tax advisor regarding the
availability of, and procedure for making, a Mark-to-Market Election with respect to the common shares.
Reporting. If we 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 U.S. Holder should consult its own tax advisor regarding our potential 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 non-U.S. 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 non-U.S. 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 holder’s particular circumstances.
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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. Holder’s 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 holder’s 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.
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.
Dividends and Paying Agents
Not applicable.
G.
Statement by Experts
Not applicable.
H.
Documents on Display
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.
We are subject to the informational requirements of the Exchange Act and are required to file reports and other information with the SEC. Our SEC filings are available at
the SEC’s website at www.sec.gov. 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.
Subsidiary Information
Not applicable.
Item 11. Quantitative and Qualitative Disclosure about Market Risk
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
21 to our audited financial statements contained in “Item 17. Financial Statements”.
Item 12. Description of Securities other than Equity Securities
A.
Debt Securities
Not applicable.
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B.
Warrants and Rights
Not applicable.
C.
Other Securities
Not applicable.
D.
American Depositary Shares
Not applicable.
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PART II
Item 13. Defaults, Dividend Arrearages and Delinquencies
None.
Item 14. Material Modification to the Rights of Security Holdings and Use of Proceeds
None.
Item 15. Controls and Procedures Disclosure Controls and Procedures
As of the end of the period covered by this annual report, our management, with the participation of our CEO and Vice President Finance, has performed an evaluation of
the effectiveness of our disclosure controls and procedures within the meaning of Rules 13a-15 (e) and 15d-15(e) of the Exchange Act. Based upon this evaluation, our
management has concluded that, as of March 31, 2019, our existing disclosure controls and procedures were effective. It should be noted that while the CEO and Vice President
Finance believe that our disclosure controls and procedures provide a reasonable level of assurance that they are effective, they do not expect the disclosure controls and
procedures to be capable of preventing all errors and fraud. A control system, no matter how well conceived or operated, can provide only reasonable, not absolute, assurance
that the objectives of the control system are met.
Management’s Report on Internal Controls over Financial Reporting
Our management, with the participation of our CEO and Vice President Finance, is responsible for establishing and maintaining adequate internal control over financial
reporting. Our internal control system was designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation and fair presentation of
its published financial statements. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be
effective may not prevent or detect misstatements and can provide only reasonable assurance with respect to financial statement preparation and presentation. Also, projections
of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of
compliance with the policies or procedures may deteriorate. Our management conducted an assessment of the design and operation effectiveness of our internal control over
financial reporting as of March 31, 2019. In making this assessment, we used the criteria established within the Internal Control—Integrated Framework (2013) issued by the
Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this assessment, our management has concluded that, as of March 31, 2019, our
internal control over financial reporting was effective.
Changes in Internal Control over Financial Reporting
No changes were made to our internal controls over financial reporting that occurred during the quarter and fiscal year ended March 31, 2019 that have materially affected,
or are reasonably likely to materially affect, our internal controls over financial reporting.
We are a non-accelerated filer under the Exchange Act and not required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of
2002. Therefore, this annual report does not include an attestation report of our registered public accounting firm regarding our management’s assessment of internal control
over financial reporting.
Item 16. Reserved
Item 16A. Audit Committee Financial Expert
Our board of directors has determined that Mr. Canan is the “audit committee financial expert”, as defined by applicable regulations of the Commission. The Commission
has indicated that the designation of Mr. Canan as an audit committee financial expert does not make him an “expert” for any purpose, impose any duties, obligations or liability
on Mr. Canan that are greater than those imposed on members of the audit committee and board of directors who do not carry this designation or affect the duties, obligations or
liability of any other member of the audit committee or board of directors.
Item 16B. Code of Ethics
The board of directors adopted a Code of Business Conduct and Ethics for our directors, officers and employees on May 31, 2007, which can be found on SEDAR at
www.sedar.com and on our web site on www.acastipharma.com. A copy of the Code of Ethics and Conduct can also be obtained by contacting our Corporate Secretary. Any
breach of the Code of Ethics must be brought to the attention of the board of directors by our CEO or other senior executive officer. No report has ever been filed which
pertains to any conduct of a director or executive officer that constitutes a breach of the Code of Business Conduct and Ethics.
- 86 -
The board of directors also adopted an insider trading program for its directors, officers and employees and adopted recently a majority voting policy for the election of
proposed director candidates at our annual general shareholders meeting.
Item 16C. Principal Accountant Fees and Services Audit Fees
“Audit fees” consist of fees for professional services for the audit of our annual financial statements, interim reviews and limited procedures on interim financial
statements, securities filings and consultations on accounting or disclosure issues. KPMG LLP, our external auditors, billed $403,500 for audit fees for the fiscal year ended
March 31, 2019 and $349,100 for audit fees for the fiscal year ended March 31, 2018.
Audit-Related Fees
“Audit-related fees” consist of fees for professional services that are reasonably related to the performance of the audit or review of our financial statements and which are
not reported under “Audit Fees” above. KPMG LLP billed $53,000 for the fiscal year ended March 31, 2019 and $8,440 for the fiscal year ended March 31, 2018. Audit-related
fees include French translation services.
Tax Fees
“Tax fees” consist of fees for professional services for tax compliance, tax advice and tax planning. KPMG LLP billed $28,100 for tax fees for fiscal year ended March 31,
2019 and $57,100 for tax fees for fiscal year ended March 31, 2018. Tax fees include, but are not limited to, preparation of tax returns.
All Other Fees
“Other fees” include all other fees billed for professional services other than those mentioned hereinabove. KPMG LLP billed no fees under this category for the fiscal
years ended March 31, 2019 and March 31, 2018.
Pre-Approval Policies and Procedures
The audit committee approves all audit, audit-related services, tax services and other non-audit related services provided by the external auditors in advance of any
engagement. Under the Sarbanes-Oxley Act of 2002, audit committees are permitted to approve certain fees for non-audit related services pursuant to a de minimus exception
prior to the completion of an audit engagement. Non-audit related services satisfy the de minimus exception if the following conditions are met:
·
·
·
the aggregate amount of all non-audit services that were not pre-approved is reasonably expected to constitute no more than five per cent of the total amount of fees paid
by us and our subsidiaries to our external auditors during the fiscal year in which the services are provided;
we or our subsidiaries, as the case may be, did not recognize the services as non-audit services at the time of the engagement; and
the services are promptly brought to the attention of the audit committee and approved, prior to the completion of the audit, by the audit committee or by one or more of
its members to whom authority to grant such approvals had been delegated by the audit committee.
None of the services described above under “Principal Accountant Fees and Services” were approved by the audit committee pursuant to the de minimus exception.
Item 16D. Exemptions from the Listing Standards for Audit Committees
Not applicable.
Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers
Not applicable.
Item 16F. Change in Registrant’s Certifying Accountant
None.
- 87 -
Item 16G. Corporation Governance
NASDAQ Marketplace Rule 5615(a)(3) permits a foreign private issuer to follow its home country practice in lieu of certain of the requirements of the Rule 5600 Series. A
foreign private issuer that follows a home country practice in lieu of one or more provisions of the Rule 5600 Series is required to disclose in its annual report filed with the
SEC, or on its website, each requirement of the Rule 5600 Series that it does not follow and describe the home country practice followed by the issuer in lieu of such NASDAQ
corporate governance requirements.
A description of the significant ways in which our governance practices currently differ from those followed by domestic companies pursuant to the Rule 5600 series is set
out below:
·
·
we do not follow NASDAQ Marketplace Rule 5620(c), but instead follow our home country practice. The NASDAQ minimum quorum requirement under Rule 5620(c)
for a meeting of shareholders is 33.33% of the outstanding shares of common voting stock. Our quorum requirement, as set forth in our by-laws, is that a quorum for a
meeting of our holders of common shares is the attendance, in person or by proxy, of the shareholders representing 10% of our common shares. The foregoing is
consistent with the laws, customs and practices in Québec, Canada, and the rules and policies of the TSX-V; and
we do not follow NASDAQ Stock Market Rule 5635(d), but instead follow our home country practice. NASDAQ Stock Market Rule 5635(d) requires each issuer to
obtain shareholder approval for the issuance of securities in connection with a transaction other than a public offering involving certain issuances of common shares in
amounts equaling 20% or more of such issuer’s common shares then outstanding. We do not follow this NASDAQ Stock Market Rule and instead comply with the
applicable requirements of the TSX-V. The TSX-V requires shareholder approval for any issuance of securities if following such issuance, we would have a new “control
person” (i.e. any individual or entity holding greater than 20% of our voting rights).
Item 16H. Mining Safety Disclosure
Not applicable.
Item 17.
Financial Statements
PART III
The financial statements of Acasti Pharma Inc. are located at the end of this annual report, beginning on page F-1.
Item 18.
Financial Statements
See Item 17.
Item 19.
Exhibits
- 88 -
EXHIBITS INDEX
Exhibit
Number
1.1
1.2
1.3
2.1
2.2
2.3
2.4
2.5
4.1
4.2
4.3
4.4
4.5
4.6*
4.7*
11.1
Description of Document
Articles of Incorporation (incorporated by reference to Exhibit 4.1 from Form S-8 (File No. 333-191383) filed with the Commission on September 25, 2013)
Amended and Restated General By-Law (incorporated by reference to Exhibit 99.1 from Form 6-K (File No. 001-35776) filed with the Commission on
February 21, 2017)
Advance Notice bylaw No. 2013-1 (incorporated by reference to Exhibit 4.3 from Form S-8 (File No. 333-191383) filed with the Commission on September
25, 2013)
Specimen Certificate for Common Shares of Acasti Pharma Inc. (incorporated by reference to Exhibit 2.1 from Form 20-F (File No. 001-35776) filed with
the Commission on June 6, 2014)
Warrant Indenture dated December 3, 2013 between Acasti Pharma Inc. and Computershare Trust Company of Canada (incorporated by reference to Exhibit
99.1 from Form 6-K (File No. 001-35776) filed with the Commission on December 3, 2013)
Warrant Indenture dated February 21, 2017 between Acasti Pharma Inc. and Computershare Trust Company of Canada (incorporated by reference to Exhibit
2.3 from Form 20-F (File No. 001-35776) filed with the Commission on June 27, 2017)
Warrant Agency Agreement dated December 27, 2017 between Acasti Pharma Inc. and Computershare Inc. and its wholly-owned subsidiary,
Computershare Trust Company N.A. (incorporated by reference to Exhibit 2.4 from Form 20-F (File No. 001-35776) filed with the Commission on June 29,
2018)
Amended and Restated Warrant Indenture dated May 10, 2018 between Acasti Pharma Inc. and Computershare Trust Company of Canada (incorporated by
reference to Exhibit 2.5 from Form 20-F (File No. 001-35776) filed with the Commission on June 29, 2018)
Prepayment Agreement, dated December 4, 2012, between Neptune Technologies & Bioressources Inc. and Acasti Pharma Inc. (incorporated by reference to
Exhibit 99.1 from Form 6-K (File No. 001-35776) filed with the Commission on October 29, 2013)
Equity Incentive Plan, as amended June 8, 2017 (incorporated by reference to Exhibit 4.2 from Form 20-F (File No. 001-35776) filed with the Commission
on June 27, 2017)
Stock Option Plan, as amended June 8, 2017 (incorporated by reference to Exhibit 4.3 from Form 20-F (File No. 001-35776) filed with the Commission on
June 27, 2017)
Employment Agreement with Jan D’Alvise, dated May 11, 2016 (incorporated by reference to Exhibit 10.6 from Form F-1 (File No. 333-220755) filed with
the SEC on September 29, 2017)
Employment Agreement with Pierre Lemieux, dated September 26, 2017 (incorporated by reference to Exhibit 10.7 from Form F-1 (File No. 333-220755)
filed with the SEC on September 29, 2017)
Employment Agreement with Brian Groch, dated May 31, 2018
Employment Agreement with Jean-François Boily, dated September 24, 2018
Code of Business Conduct and Ethics for Directors, Officers and Employees (incorporated by reference to Exhibit 99.4 from Form 40-F (File No. 001-
35776) filed with the Commission on May 30, 2013)
- 89 -
12.1*
12.2*
13.1*
13.2*
15.1*
15.2*
* Filed herewith.
Principal Executive Officer Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Principal Financial Officer Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Principal Executive Officer Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Principal Financial Officer Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Consent of KPMG LLP
Consent of Destum Partners, Inc.
- 90 -
The registrant hereby certifies that it meets all of the requirements for filing on this Annual Report and that it has duly caused and authorized the undersigned to sign
this Annual Report on its behalf.
SIGNATURES
Date: June 26, 2019
ACASTI PHARMA INC.
By:
Name:
Title:
/s/ Jan D’Alvise
Jan D’Alvise
Principal Executive Officer
- 91 -
Financial Statements of
ACASTI PHARMA INC.
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February
28, 2017
F-1
KPMG LLP
600 de Maisonneuve Blvd. West
Suite 1500, Tour KPMG
Montréal (Québec) H3A 0A3
Canada
Telephone
Fax
Internet
(514) 840-2100
(514) 840-2187
www.kpmg.ca
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and Board of Directors
Acasti Pharma Inc.
Opinion on the Financial Statements
We have audited the accompanying statements of financial position of Acasti Pharma, Inc. (the Company) as of March 31, 2019 and 2018, the related statements of earnings
and comprehensive loss, changes in equity, and cash flows for the years ended March 31, 2019 and 2018 and the thirteen-month period ended March 31, 2017, and the related
notes (collectively, the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of
March 31, 2019 and 2018, and its financial performance and its cash flows for the years ended March 31, 2019 and 2018 and the thirteen-month period ended March 31, 2017,
in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.
Material Uncertainty Related to Going Concern
Without qualifying our opinion on the financial statements, we draw attention to Note 2 (c) to the financial statements, which indicates that the Company has incurred operating
losses and negative cash flows from operations since inception, and additional funds will be needed in the future for activities necessary to prepare for commercial launch. These
events or conditions, along with other matters as set forth in Note 2 (c), indicate that a material uncertainty exists that casts substantial doubt on the Company’s ability to
continue as a going concern.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.
We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to
the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about
whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an
audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the
purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
KPMG LLP is a Canadian limited liability partnership and a member firm of the KPMG
network of independent member firms affiliated with KPMG International Cooperative
("KPMG International"), a Swiss entity.
KPMG Canada provides services to KPMG LLP.
F-2
Page 2
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that
respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included
evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe
that our audits provide a reasonable basis for our opinion.
Other Matter
The financial statements of Acasti Pharma Inc. for the twelve-month and one-month periods ended February 28, 2017 and March 31, 2017 respectively are unaudited.
Accordingly, we do not express an opinion on them.
We have served as Company’s auditor since 2009.
Montreal, Canada
June 26, 2019
*CPA auditor, CA, public accountancy permit No. A122596
F-3
ACASTI PHARMA INC.
Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
Financial Statements
Statements of Financial Position
Statements of Earnings and Comprehensive Loss
Statements of Changes in Equity
Statements of Cash Flows
Notes to Financial Statements
F-4
F-5
F-6
F-7
F-9
F-10
ACASTI PHARMA INC.
Statements of Financial Position
As at March 31, 2019 and March 31, 2018
(thousands of Canadian dollars)
Assets
Current assets:
Cash and cash equivalents
Marketable securities
Receivables
Other Assets
Deferred financing costs
Prepaid expenses
Total current assets
Marketable securities
Other Asset
Equipment
Intangible assets
Total assets
Liabilities and Equity
Current liabilities:
Trade and other payables
Unsecured convertible debentures
Total current liabilities
Derivative warrant liabilities
Unsecured convertible debentures
Total liabilities
Equity:
Share capital
Other equity
Contributed surplus
Deficit
Total equity
Commitments and contingencies
Total liabilities and equity
See accompanying notes to financial statements.
On behalf of the Board:
/s/ Dr. Roderick Carter
Roderick Carter
Chair of the Board
/s/ Jean-Marie Canan
Jean-Marie Canan
Director
F-5
Notes
24
5
4
6
14(b)
5
6
9
10
11
13
12, 14(d)( e)
13
14
14
22
March 31, 2019
March 31, 2018
$
$
22,521
11,865
1,586
65
179
1,115
37,331
27
557
2,813
7,743
48,471
16,429
1,817
18,246
16,263
–
34,509
129,318
309
8,280
(123,945)
13,962
8,223
–
759
104
–
406
9,492
26
555
2,821
10,065
22,959
6,697
–
6,697
6,426
1,612
14,735
73,338
309
6,956
(72,379)
8,224
48,471
22,959
ACASTI PHARMA INC.
Statements of Earnings and Comprehensive Loss
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except per share
data)
Research and development expenses, net of
government assistance
General and administrative expenses
Loss from operating activities
Notes
8
Thirteen-
months
ended
March 31,
2019
March 31,
March 31,
2018
2017
Month ended
March 31,
2017
(Unaudited)
Twelve-
months
ended
February 28,
2017
(Unaudited)
$
$
$
$
$
(38,366)
(6,649)
(45,015)
(15,669)
(4,027)
(19,696)
(7,653)
(3,557)
(11,210)
(426)
(292)
(718)
(7,227)
(3,265)
(10,492)
Financial expenses
12, 14 (d)(e), 16
(6,551)
(1,808)
(166)
(51)
(115)
Net loss and comprehensive loss before income tax
Deferred income tax recovery
Net loss and total comprehensive loss
(51,566)
–
(51,566)
(21,504)
–
(21,504)
(11,376)
129
(11,247)
(769)
–
(769)
(10,607)
129
(10,478)
Basic and diluted loss per share
18
(0.95)
(1.23)
(1.01)
(0.05)
(0.97)
Weighted average number of shares outstanding
54,290,295
17,486,515
11,094,512
14,702,556
10,788,075
See accompanying notes to financial statements
F-6
ACASTI PHARMA INC.
Statements of Changes in Equity
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars)
Notes
Share capital
Number
Dollar
$
Other Contributed
surplus
equity
$
$
Deficit
$
Total
$
Balance, March 31, 2018
25,638,215
73,338
309
6,956
(72,379)
8,224
Net loss and total comprehensive loss for the
period
Transactions with owners, recorded
directly in equity
Contributions by and distributions to equity
holders
Public offering
Warrants exercised
Share-based payment transactions
Issuance of shares for payment of interest on
convertible debentures
Total contributions by and distributions to
equity holders
Balance at March 31, 2019
—
25,638,215
—
73,338
—
309
—
6,956
(51,566)
(123,945)
(51,566)
(43,342)
14(c)(d)
17
14(g)
51,612,000
772,474
4,167
54,124
1,733
3
105,878
120
52,494,519
78,132,734
55,980
129,318
—
—
—
—
—
309
283
—
1,041
–
—
—
—
—
1,324
8,280
—
(123,945)
54,407
1,733
1,044
120
57,304
13,962
(thousands of Canadian dollars)
Notes
Share capital
Number
Dollar
$
Other Contributed
surplus
equity
$
$
Deficit
$
Total
$
Balance, March 31, 2017
14,702,556
66,576
309
5,693
(50,875)
21,703
Net loss and total comprehensive loss for the
period
Transactions with owners, recorded
directly in equity
Contributions by and distributions to equity
holders
Public offering
Warrants exercised
Share-based payment transactions
Issuance of shares for payment of interest on
convertible debentures
Total contributions by and distributions to
equity holders
Balance at March 31, 2018
See accompanying notes to financial statements.
—
14,702,556
—
66,576
—
309
—
5,693
(21,504)
(72,379)
(21,504)
199
14(e)
17
14(g)
10,667,169
178,721
—
89,769
10,935,659
25,638,215
6,169
456
—
137
6,762
73,338
—
—
—
—
—
309
406
(72)
929
—
—
—
—
1,263
6,956
—
(72,379)
6,575
384
929
137
8,025
8,224
F-7
ACASTI PHARMA INC.
Statements of Changes in Equity, Continued
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars)
Notes
Share capital
Number
Dollar
$
Other Contributed
surplus
equity
$
$
Deficit
$
Total
$
Balance, February 29, 2016
10,712,038
61,973
–
4,875
(39,628)
27,220
Net loss and total comprehensive loss for the twelve-month period
(unaudited)
Net loss and total comprehensive loss for the one-month period
(unaudited)
Net loss and total comprehensive loss for the thirteen-month
Period
Transactions with owners, recorded directly in equity
Contributions by and distributions to equity holders
Public offering
Issue of unsecured convertible debentures, net of deferred
income tax expense of $129
Equity settled non-employee share-based payment
Share-based payment transactions for the twelve-month period
(unaudited)
Share-based payment transactions for the one-month period
(unaudited)
Share-based payment transactions for the thirteen-month period
Total contributions by and distributions to equity holders for the
twelve-month period (unaudited)
Total contributions by and distributions to equity holders for the
one-month period (unaudited)
Total contributions by and distributions to equity holders for the
thirteen-month period
Balance at February 28, 2017 (unaudited)
Balance at March 31, 2017
See accompanying notes to financial statements.
—
—
—
—
—
10,712,038
—
61,973
—
—
—
—
—
(10,478)
(10,478)
—
(769)
(769)
—
4,875
(11,247)
(50,875)
(11,247)
15,973
14(f)
3,930,518
4,509
–
144
—
4,653
13, 20
—
60,000
17
17
17
—
—
—
—
94
—
—
—
309
—
—
—
—
—
—
588
86
674
—
—
—
—
—
309
94
588
86
674
3,990,518
4,603
309
732
—
5,644
—
—
—
86
—
86
3,990,518
14,702,556
14,702,556
4,603
66,576
66,576
309
309
309
818
5,607
5,693
—
(50,106)
(50,875)
5,730
22,386
21,703
F-8
ACASTI PHARMA INC.
Statements of Cash Flows
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
Notes
10
9
17
16
19
9, 19
14(c)(d)(e)(f)
13, 14(f)
(thousands of Canadian dollars)
Cash flows used in operating activities:
Net loss for the period
Adjustments:
Amortization of intangible assets
Depreciation of equipment
Stock-based compensation
Net financial expenses
Realized foreign exchange gain (loss)
Deferred income tax recovery
Total adjustments
Changes in working capital items
Net cash used in operating activities
Cash flows from (used in) investing activities:
Interest received
Acquisition of equipment
Acquisition of short-term investments
Acquisition of marketable securities
Maturity of short-term investments
Maturity of marketable securities
Net cash (used in) investing activities
Cash flows from (used in) financing activities:
Net proceeds from public offering
Net proceeds from private placement
Proceeds from exercise of warrants
Share based payment
Interest paid
Net cash from (used in) financing activities
Foreign exchange (loss) gain on cash and cash equivalents
held in foreign currencies
Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents, beginning of period
Cash and cash equivalents, end of period
Cash and cash equivalents is comprised of:
Cash
Cash equivalents
See accompanying notes to financial statements.
Thirteen-
months
ended Month ended
March 31,
2019
March 31,
2018
March 31,
2017
$
$
$
(51,566)
(21,504)
(11,247)
March 31,
2017
(Unaudited)
$
(769)
Twelve-
months
ended
February 28,
2017
(Unaudited)
$
(10,478)
2,323
349
929
1,808
(7)
-
(16,102)
3,583
(12,519)
70
(455)
-
(26)
-
2,517
221
674
166
48
(129)
(7,750)
792
(6,958)
150
(2,527)
(12,765)
-
22,030
(411)
6,888
11,065
(40)
384
-
(3)
11,406
(25)
(1,549)
9,772
8,223
5,010
1,872
-
-
(18)
6,864
(49)
6,745
3,027
9,772
194
32
86
51
(12)
-
(418)
(328)
(746)
4
(24)
-
-
-
(20)
(34)
(10)
-
-
-
(44)
9
(801)
10,573
9,772
2,323
189
588
115
60
(129)
(7,332)
1,120
(6,212)
146
(2,503)
(12,765)
-
22,030
6,908
5,044
1,882
-
-
(18)
6,908
(58)
7,546
3,027
10,573
1,583
6,640
6,778
2,994
6,778
2,994
7,584
2,989
2,322
505
1,041
6,551
581
-
(40,566)
8,090
(32,476)
384
(700)
-
(23,753)
-
11,933
(12,136)
57,892
-
1,011
3
(44)
58,862
48
14,298
8,223
22,521
1,896
20,625
F-9
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
1.
Reporting entity
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.
The Corporation is subject to a number of risks associated with its ongoing priorities, including the conduct of its clinical program and its results, the establishment of strategic
alliances and the development of new pharmaceutical products and their marketing. The Corporation’s current product in development requires approval from the U.S Food
and Drug Administration and equivalent regulatory organizations in other countries before their sale can be authorized. Certain risks have been reduced for the longer term
with the outcome of the Corporation’s actions, including its intellectual property strategy execution with filed patent applications in more than 20 jurisdictions, with more than
20 issued patents and with numerous additional patent applications pending.
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, units consisting of Common Shares and warrants 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 ability of the Corporation
to complete the needed financing and ultimately achieve profitable operations is dependent on a number of factors outside of the Corporation’s control.
2.
(a)
Basis of preparation
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 Corporation’s 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, for comparative purposes 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 26, 2019.
(b)
Basis of measurement:
The financial statements have been prepared on the historical cost basis, except for:
·
·
Stock-based compensation which is measured pursuant to IFRS 2, Share-based payments (Note 3(e) (ii)); and,
Derivative warrant liabilities measured at fair value on a recurring basis (Note 12).
(c)
Going concern uncertainty:
The Corporation has incurred operating losses and negative cash flows from operations since inception. The Corporation’s current assets of $37.3 million as at March 31,
2019 include cash and cash equivalents totaling $22.5 million, and marketable securities of $11.9 million mainly generated by the net proceeds from the recent Public
Offerings. The Corporation’s current liabilities total $18.2 million at March 31, 2019 and are comprised primarily of amounts due to or accrued for creditors. Management
projects that additional funds will be needed in the future, after TRILOGY phase 3 clinical trials, for activities necessary to prepare for commercial launch, including the scale
up of our manufacturing operations, the completion of the potential regulatory (NDA) submission package (assuming positive Phase 3 clinical results), and the expansion of
business development and US commercial launch activities. The Corporation is working towards development of strategic partner relationships, as well as actively seeking
additional non-dilutive funds in the future, but there can be no assurance as to when or whether Acasti will complete any strategic collaborations or succeed in identifying non-
dilutive funding sources. Consequently, the Corporation may need to raise additional equity capital in the future to fund these activities. In particular, raising additional capital
is subject to market conditions and is not within the Corporation’s control. If the Corporation does not raise additional funds or find one or more strategic partners, 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
Corporation’s ability to continue as a going concern and, therefore, realize its assets and discharge its liabilities in the normal course of business.
F-10
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
2.
(c)
Basis of preparation (continued):
Going concern uncertainty (continued):
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 Corporation’s assets, including the intangible asset, could be
required.
(d)
Functional and presentation currency:
These financial statements are presented in Canadian dollars, which is the Corporation’s 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 management’s 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:
·
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)).
Assumptions and estimation uncertainties that have a significant risk of resulting in a material adjustment within the next financial year include the following:
·
(f)
Measurement of derivative warrant liabilities (note 12) and stock-based compensation (note 17).
Use of estimates and judgments (continued):
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, marketable securities 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.
Cash, cash equivalents, marketable securities and receivables with maturities of less than one year are classified at amortized cost as they meet both of the following
conditions; they are held within a business model whose objective is to hold assets to collect contractual cash flows and its contractual terms give rise on specified dates to
cashflows that are solely payments of principal and interest on the principal amount outstanding. Cash and cash equivalents comprise cash balances and highly liquid
investments purchased three months or less from maturity.
F-11
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
3.
Significant accounting policies (continued):
(ii)
Non-derivative financial liabilities:
The Corporation has the following non-derivative financial liabilities: trade and other payables. 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.
(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.
(iv)
Share capital:
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 as a component of finance expense (income).
(vi)
Other equity instruments:
Warrants, options and rights over the Corporation’s equity issued outside of share-based payment transactions that do not meet the definition of a liability instrument are
recognized in equity.
(b)
Equipment:
(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.
(ii)
Subsequent costs:
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
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
3.
Significant accounting policies (continued):
(iii)
Depreciation:
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
Furniture and office equipment
Computer equipment
Laboratory equipment
Production equipment (in years)
Method
Declining balance
Declining balance
Declining balance
Straight-line
20%
30%
Period/Rate
to
30%
30%
10
Depreciation methods, useful lives and residual values are reviewed at each financial year-end and adjusted prospectively if appropriate.
(c)
Intangible assets:
(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.
(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.
(iv)
Amortization:
Amortization is calculated over the cost of the intangible asset less its residual value.
F-13
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
3.
Significant accounting policies (continued):
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
Patents
License
(d)
Impairment:
(i)
Financial assets:
Period (in years)
20
to
8
14
The Corporation assesses at each reporting date the expected credit loss for calculating impairment of financial assets and recognizes expected credit losses as loss allowances
for assets measured at amortized cost.
(ii)
Non-financial assets:
The carrying amounts of the Corporation’s 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 asset’s 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”).
The Corporation’s 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 asset’s 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.
(e)
Employee benefits:
(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.
F-14
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
3.
Significant accounting policies (continued):
(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)
Provisions:
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 a component of finance expense
(income).
(i)
Onerous contracts:
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.
(g)
Government grants:
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.
(h)
Lease payments:
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.
(i)
Foreign currency:
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 translated 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 translation are recognized in profit or loss.
F-15
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
3.
(j)
Significant accounting policies (continued):
Finance income and finance expense:
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, accretion on borrowings, unwinding of the discount on provisions, impairment losses recognized on financial assets, transaction costs
for issuance of derivative warrant liabilities and changes of fair value of derivative warrant liabilities. 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.
(k)
Income tax:
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 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, enacted or substantively enacted, 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.
(l)
Earnings per share:
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.
(m)
Segment reporting:
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
Corporation’s assets are located in Canada, while one major production unit, with a carrying value of $1,831 (March 31, 2018 - $2,077), is located in France.
F-16
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
3.
(n)
Significant accounting policies (continued):
Change in accounting policy:
Adoption of new accounting standards
The accounting policies used in these annual financial statements are consistent with those applied by the Corporation in its March 31, 2018 annual financial statements
except for the amendments to certain accounting standards which are relevant to the Corporation and were adopted by the Corporation as of April 1, 2018 as described below.
(i)
Financial instruments:
IFRS 9, Financial Instruments, replaces IAS 39, Financial Instruments: Recognition and Measurement. IFRS 9 introduces a revised approach for the classification of financial
assets based on how an entity manages financial assets and the characteristics of the contractual cash flows of the financial assets replacing the multiple rules in IAS 39. Most
of the requirements in IAS 39 for classification and measurement of financial liabilities have been carried forward in IFRS 9. IFRS 9 also introduces a new hedge accounting
model that is more closely aligned with risk-management activities and a new expected credit loss model for calculating impairment on financial assets replacing the incurred
loss model in IAS 39. The Corporation adopted IFRS 9 as of April 1, 2018 and assessed the impact of the adoption on its financial statements, and determined there was no
material impact. The Corporation does not apply hedge accounting.
(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 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 adopted the amendments to IFRS 2 as of April 1, 2018 and assessed the impact of the
adoption of IFRS 2 on its financial statements, and determined that there was no material impact.
Future accounting change:
The following new standards, and amendments to standards and interpretations, are not yet effective for the period ended March 31, 2019, and have not been applied in
preparing these financial statements.
New standards and interpretations not yet adopted:
(i)
Leases – IFRS 16
IFRS 16, Leases (“IFRS 16”) In January 2016, the IASB issued IFRS 16, a new standard that replaces IAS 17, Leases. IFRS 16 is a major revision of the way in which
companies account for leases and will no longer permit off balance sheet leases. Adoption of IFRS 16 is mandatory and will be effective for the Corporation’s fiscal year
beginning on April 1, 2019. The Corporation is assessing the impact of adoption of IFRS 16, and currently there is only one lease that will be impacted by this new standard
and the impact is expected to be minimal.
4.
Receivables:
Sales tax receivables
Government assistance and tax credits receivable
Interest receivable
Other receivables
Total receivables
Notes
8
March 31, 2019
$
618
872
80
16
1,586
March 31, 2018
$
470
282
-
7
759
F-17
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
5.
Marketable Securities
The corporation holds various marketable securities with maturities greater than 90 days at the time of purchase as follows:
Term deposit issued in US currency [US $20], earning interest at 2.23% and maturing on March 13, 2019
Term deposits issued in US currency [US $2,020], earning interest at 2.50% and maturing on various dates from April 8,
2019 to March 12, 2020
Treasury bills issued in CAD currencyearning interest at rates ranging from 1.83% to 1.90% and maturing on various
dates from April 2, 2019 to July 25, 2019
Total Marketable securities
Current marketable securities
Marketable securities
6.
Other Assets
March 31, 2019
$
March 31, 2018
$
-
2,696
9,196
11,892
11,865
27
26
-
-
26
-
26
During the year, the Corporation owned a reserve of krill oil in which amounts are expensed as it is being used. The following table summarizes information regarding
activities of amounts of the krill oil usage in the R&D production processes and for NKPL66 manufacturing for the year (see note 7 (a)):
Balance – beginning of year
Purchased
Used
Balance – end of year
Current other asset
Other asset
7.
Related parties:
March 31, 2019
$
659
68
(105)
622
March 31, 2018
$
-
970
(311)
659
65
557
104
555
Neptune Technologies (Neptune) Acasti’s former parent company, owned approximately 6.5% of the issued and outstanding Class A shares (Common Shares) of the
Corporation as at March 31, 2019. Neptune’s ownership reduced below a control position, following Acasti’s U.S. public financing activities in December 2017 and January
2018.
(a)
Administrative and research and development expenses:
The Corporation has significantly reduced its reliance on the support of Neptune for a portion of its general and administrative needs; however, it will continue to utilize their
IT support for the near term. 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:
F-18
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
7.
Related parties (continued):
Research and development expenses
Supplies and incremental costs
Shared service agreement
Total
General and administrative expenses
Supplies and incremental costs
Shared service agreement
Total
Total related parties expenses
March 31,
2019
March 31,
2018
Thirteen-
months ended
March 31,
2017
$
-
-
-
211
34
245
245
$
$
7
20
27
239
121
360
387
-
60
60
293
325
618
678
Month ended
March 31,
2017
(Unaudited)
$
Twelve-months
ended
February 28,
2017
(Unaudited)
$
-
1
1
16
25
41
42
-
59
59
277
300
577
636
Where Neptune incurs specific incremental costs for the benefit of the Corporation, it charges those amounts directly. Neptune provides Acasti with the services of personnel
for certain administrative work as part of a shared service agreement. The employees’ salaries and benefits are charged proportionally to the time allocation agreed upon
within the shared service agreement. Effective September 30, 2017, the laboratory support, the corporate affairs and the public company reporting services previously
provided by Neptune as part of the shared service agreement were discontinued. The Corporation is now incurring incremental costs and expects to do so in the future,
partially offset by reduced shared service fees. The account payable to Neptune amounted to $2 at March 31, 2019 and $44 at March 31, 2018, is non-interest bearing and has
no specified maturity date. 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.
Historically, Neptune has provided the Corporation with the krill oil needed to produce CaPre for Acasti’s clinical programs, including all of the krill oil projected to be
needed for its Phase 3 clinical study program. However, Neptune discontinued its krill oil production and sold its krill oil inventory to Aker on August 7, 2017. In 2017 Acasti
purchased a reserve of krill oil from Aker that will be used in the production of CaPre capsules for its Phase 3 clinical trials (see also note 6). The Corporation is currently
evaluating alternative suppliers of krill oil. At March 31, 2019, a reserve of krill oil owned by the Corporation was physically stored at Neptune’s facility.
(b)
Interest revenue:
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 of nil for the years ended March 31, 2019 and 2018, $89 for the thirteen-month period ended March
31, 2017, nil (unaudited) for the month ended March 31, 2017, and $89 (unaudited) for the twelve-month period ended February 28, 2017.
F-19
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
7.
(c)
Related parties (continued):
Key management personnel compensation:
The key management personnel are the officers of the Corporation and the members of the Board of Directors of the Corporation. They control in the aggregate less than 1%
of the voting shares of the Corporation (less than 1% in 2018 and 2% in 2017).
Key management personnel compensation includes the following for the years ended March 31, 2019 and 2018, the thirteen-month and one-month periods ended March 31,
2017 and the twelve-month period ended February 28, 2017.
Compensation
Share-based compensation costs
Total key management personnel compensation
8.
Government assistance:
$
1,641
940
2,581
March 31,
2019
March 31,
2018
Thirteen-
months ended
March 31,
2017
$
$
Month ended
March 31,
2017
(Unaudited)
$
Twelve-months
ended
February 28,
2017
(Unaudited)
$
1,754
826
2,580
1,510
619
2,129
146
78
224
1,364
541
1,905
Investment tax credit
Government grant
Total government assistance
March 31,
2019
March 31,
2018
Thirteen-
months ended
March 31,
2017
$
588
7
595
$
409
-
409
$
103
227
330
Month ended
March 31,
2017
(Unaudited)
$
8
37
45
Twelve-months
ended
February 28,
2017
(Unaudited)
$
95
190
285
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
2030
2031
2032
2033
2034
2035
2036
2037
2038
2039
F-20
$
11
30
45
431
441
436
519
286
315
324
329
3,167
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
9.
Equipment:
Cost:
Balance at February 29, 2016
Additions for the twelve-month period (Unaudited)
Balance at February 28, 2017 (Unaudited)
Additions for the one-month period (Unaudited)
Additions for the thirteen-month period
Balance at March 31, 2017
Additions
Balance at March 31, 2018
Additions
Balance at March 31, 2019
Accumulated depreciation:
Balance at February 29, 2016
Depreciation for the twelve-month period (Unaudited)
Balance at February 28, 2017 (Unaudited)
Depreciation for the one-month period (Unaudited)
Depreciation for thirteen-month period
Balance at March 31, 2017
Depreciation
Balance at March 31, 2018
Depreciation
Balance at March 31, 2019
Net carrying amounts:
March 31, 2018
March 31, 2019
Furniture and
office equipment
$
Computer
equipment
$
Laboratory
equipment
$
Production
equipment
$
59
-
59
-
-
59
4
63
5
68
52
7
59
-
7
59
-
59
1
60
4
8
3
8
11
-
8
11
6
17
13
30
3
1
4
-
1
4
3
7
7
14
10
16
336
186
522
-
186
522
192
714
219
933
56
129
185
11
140
196
107
303
180
483
411
450
-
2,484
2,484
43
2,527
2,527
181
2,708
260
2,968
-
52
52
21
73
73
239
312
317
629
2,396
2,339
Total
$
398
2,678
3,076
43
2,721
3,119
383
3,502
497
3,999
111
189
300
32
221
332
349
681
505
1,186
2,821
2,813
Depreciation expense for the periods end March 31, 2019 and 2018, the thirteen-month and one-month periods ended March 31, 2017 and twelve-month period ended
February 28, 2017 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
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
10.
Intangible assets :
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. The license allows the Corporation to exploit the intellectual property rights in order to develop novel active pharmaceutical
ingredients (“APIs”) into commercial products for the prescription drugs market. The license Agreement, together with the Corporation own IP, allows the “freedom to
operate” for CaPre, which is currently the Corporation’s only prescription drug candidate in development. The Corporation believes that upon the expiry of the last licensed
Neptune patent in 2022, the Corporation’s expanding patent portfolio will cover CaPre, and that it will not require any license from Neptune to support the commercialization
of CaPre.
Cost:
Balance at February 29, 2016, February 28, 2017 (Unaudited) and March 31, 2017
Additions
Balance at March 31, 2018
Additions
Balance at March 31, 2019
Accumulated amortization:
Balance at February 29, 2016
Amortization for the twelve-month period (Unaudited)
Balance at February 28, 2017 (Unaudited)
Amortization for the one-month period (Unaudited)
Amortization for the thirteen-month period
Balance at March 31, 2017
Amortization for the year
Balance at March 31, 2018
Amortization for the year
Balance at March 31, 2019
Net carrying amounts:
March 31, 2018
March 31, 2019
Patents
$
License
$
362
-
362
-
362
362
-
362
-
-
362
-
362
-
362
-
-
24,330
-
24,330
-
24,330
9,425
2,323
11,748
194
2,517
11,942
2,323
14,265
2,322
16,587
10,065
7,743
Total
$
24,692
-
24,692
-
24,692
9,787
2,323
12,110
194
2,517
12,304
2,323
14,627
2,322
16,949
10,065
7,743
Amortization expense and impairment loss for the period ended March 31, 2019 and 2018, the thirteen-month and one-month periods ended March 31, 2017, and the twelve-
month period ended February 28, 2017 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
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
11.
Trade and other payables:
Trade payables
Accrued liabilities and other payables
Employee salaries and benefits payable
Legal settlement expected to be paid via common shares (note 25)
Payable to Neptune
Total trade and other payables
March 31, 2019
March 31, 2018
$
4,064
10,319
1,054
990
2
16,429
$
3,420
2,479
754
-
44
6,697
The Corporation’s exposure to currency and liquidity risks related to trade and other payables is presented in Note 21.
12.
Derivative warrant liabilities:
The warrants issued as part of the public offering of units composed of Common Share and Common Share purchase warrants on both May 9, 2018 and May 14, 2018 (see
note 14) are derivative liabilities (“Derivative Warrant Liabilities”) given the warrant indenture contains certain contingent provisions that allow for cash settlement.
Warrants issued as part of a public offering of units composed of class A share (Common Share) and Common Share purchase warrants on both December 27, 2017 and
December 3, 2013 are derivative liabilities (“Derivative warrant liabilities”) given the currency of the exercise price is different from the Corporation’s 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 tables:
Balance – beginning of period
Issued during period
Exercised during period
Change in fair value of derivative warrant liabilities
Balance – end of period
Warrant liabilities issued
May 2018
Warrant liabilities issued
December 27, 2017
Warrant liabilities issued
December 3, 20131
March 31,
March 31,
March 31,
March 31,
March 31,
2019
$
-
4,272
(722)
4,696
8,246
2018
$
-
-
-
-
-
2019
$
6,405
-
-
1,612
8,017
2018
$
-
5,873
-
532
6,405
2019
$
21
-
-
(21)
-
March 31,
2018
$
209
-
-
(188)
21
Fair value per share issuable
(1) In order to obtain one Common Share, 10 warrants must be exercised. All unexercised warrants expired on December 3, 2018.
0.81
-
0.82
0.65
-
0.01
F-23
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
12.
Derivative warrant liabilities (continued):
The fair value of the derivative warrant liabilities was estimated using the Black-Scholes option pricing model and based on the following assumptions:
Warrant liabilities issued
May 2018
Warrant liabilities issued
December 27, 2017
Exercise price
Share price
Risk-free interest
Estimated life (in years)
Expected volatility
(1) In order to obtain one Common Share, 10 warrants must be exercised. All unexercised warrants expired on December 3, 2018.
-
-
-
-
-
$
$
2.23%
3.75
107.57%
March 31,
2018
March 31,
2019
US $1.26
US $1.02
March 31,
2019
1.31
1.35
1.52%
4.11
94.58%
March 31,
2018
US $1.26
US $1.02
2.56%
4.75
95.15%
Warrant liabilities issued
December 3, 2013 1
March 31,
2019
-
-
-
-
-
March 31,
2018
US $1.50
US $1.02
2.19%
0.68
133.86%
13.
Unsecured convertible debentures
Concurrent with the Public Offering described in note 14, on February 21, 2017, the Corporation 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 any time 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 Corporation’s
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 Corporation’s 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.
F-24
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
13.
Unsecured convertible debentures (continued):
The split between the liability and equity component portions of the Private Placement are summarized below:
Balance at March 31, 2017
Effective interest for the twelve-month period
Interest payable during the period
Balance at March 31, 2018
Effective interest during the period
Interest payable during the period
Balance at March 31, 2019
14.
(a)
Capital and other components of equity
Share capital:
Authorized capital stock:
Unlimited number of shares:
Liability component
Equity component
$
1,406
366
(160)
1,612
365
(160)
1,817
$
309
-
-
309
-
-
309
Total Private
Placement
$
1,715
366
(160)
1,921
365
(160)
2,126
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 holder’s discretion, into Class A shares (Common Shares), on a one-for-one basis, and Class B shares are
redeemable at the holder’s discretion for $0.80 per share, subject to certain conditions. There are non issued and outstanding.
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 holder’s discretion, into Class A shares (Common Shares), on a one-for-one basis, and Class C shares are redeemable at the holder’s
discretion for $0.20 per share, subject to certain conditions. There are non issued and outstanding.
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 holder’s discretion, into Class A shares (Common Shares), on a one-for-one basis, and Class D
and E shares are redeemable at the holder’s discretion, subject to certain conditions. There are non issued and outstanding.
(b)
“At-the-market” (“ATM”) sales agreement
On February 14, 2019, the Corporation entered into an “at-the-market” (“ATM”) sales agreement with an underwriter B. Riley FBR, Inc. (B. Riley), pursuant to which the
Corporation’s common shares may be sold from time to time for aggregate gross proceeds of up to US $30 million, with sales only being made on the NASDAQ Stock
Market. The common shares would be issued at market prices prevailing at the time of the sale and, as a result, prices may vary between purchasers and during the period of
distribution. The ATM provides the Company with a flexible alternative for raising additional capital. The ATM has a 3 year term, and requires the company to pay a 3% fee
to B. Riley when any sales are made. As at March 31, 2019, no securities have been issued in relation to the ATM. Costs incurred in connection to the ATM of $179 have
been recorded as deferred financing costs.
(c)
Public Offerings – October 2018:
On October 9, 2018, the Corporation closed a U.S. public offering of 16,600,000 Common Shares at a price of US$1.00 per share. In addition, the underwriters fully exercised
their over-allotment option to purchase 2,490,000 additional Common Shares at the same public offering price. This offering generated gross proceeds of $24.7 million
(US$19.1 million), which resulted in net proceeds to the Corporation of $22.6 million (US$17.4 million) and a total of 19,090,000 Common Shares issued.
F-25
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
14.
Capital and other components of equity (continued):
On October 23, 2018, the Corporation closed a Canadian public offering of 18,750,000 Common Shares at a price of $1.28 per share. In addition, the underwriters fully
exercised their over-allotment option to purchase 2,812,500 additional Common Shares at the same public offering price. This offering generated gross proceeds of $27.6
million, which resulted in net proceeds to the Corporation of approximately $25.4 million and a total of 21,562,500 Common Shares issued.
(d)
Public Offering – May 2018:
On May 9, 2018 the Corporation closed a Canadian public offering issuing 9,530,000 units of Acasti (“Units”) at a price of $1.05 per Unit for gross proceeds of $10 million.
The units issued consist of 9,530,000 Common Shares and 9,530,000 Warrants. Each Warrant entitles the holder thereof to acquire one Common Share of the Corporation at
an exercise price of $1.31 at any time until May 9, 2023.
On May 14, 2018, the underwriters exercised their over-allotment option by purchasing an additional 1,429,500 units at a price of $1.05 per Unit, for additional gross
proceeds of $1.5 million. The units issued consist of 1,429,500 Common Shares and 1,429,500 warrants. Each Warrant entitles the holder thereof to acquire one Common
Share of the Corporation at an exercise price of $1.31 at any time until May 9, 2023.
The warrant component of these Units are Derivative Warrant Liabilities for accounting purposes due to the warrant agreement, which contains certain contingent provisions
that allow for cash settlement (note 12). The proceeds of the offering are required to be split between the Derivative Warrant Liabilities and the equity-classified Common
shares at the time of issuance of the Units. The fair value of the Derivative Warrant Liabilities at the time of issuance was determined to be $4.3 million and the residual of the
proceeds of $6.2 million were allocated to the Common Shares. Issuance costs related to this transaction totaled approximately $1.8 million and have been allocated between
the Derivative Warrant Liabilities and Common shares based on relative value. Resulting from this allocation, $0.7 million has been allocated to the Derivative Warrant
Liability and is recognized in finance costs in the Statements of Earnings and Comprehensive Loss, whereas the remaining portion of $1.1 million in issuance costs was
allocated to the Common Shares and recognized as a reduction to share capital, in the Statements of Financial Position.
The fair value of the public offering warrants at issuance was estimated using to the Black-Scholes option pricing model and was based on the following weighted average
assumptions:
Exercise price
Share price
Risk-free interest
Estimated life (in years)
Expected volatility
$
$
May 2018
1.31
0.82
2.21%
5
87.40%
The weighted average fair value of the public offering warrants issued in May 2018 was determined to be $0.39 per warrant. Changes in the subsequent measurement of fair
value of the Warrants are recognized in financial expenses.
As part of the transaction, the Corporation also issued broker warrants to purchase up to 547,975 Common Shares. Each broker warrant entitles the holder thereof to acquire
one Common Share of the Corporation at an exercise price of $1.05, at any time until May 9, 2023. The broker warrants are considered to be compensation to non-employees
under IFRS 2, as stock-based compensation, and are thus accounted for at fair value at issuance date and not subsequently revalued. To determine the fair value of these
broker warrants, a Black-Scholes options pricing model was used based on the following assumptions:
Exercise price
Share price
Risk-free interest
Estimated life (in years)
Expected volatility
The total value associated with the broker warrants amounted to $283 and was recorded in contributed surplus.
F-26
$
$
May 2018
1.05
0.81
2.20%
5
87.40%
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
14.
(e)
Capital and Other Components of Equity (continued):
Public offering – December 27, 2017
On December 27, 2017, the Corporation closed a U.S. public offering issuing 9,900,990 units of Acasti at a price of US$1.01 per Unit for gross proceeds of $12.6 million
(US$10 million). The units issued consist of 9,900,990 Common Shares and 8,910,891 warrants with the right to purchase one Common Share of Acasti. As part of this
closing, the underwriters’ also partially exercised for nil consideration the over-allotment option for warrants, which were issued for a right to purchase 892,044 Common
Shares at an exercise price of US$1.26.
The Warrants forming part of the Units are Derivative Warrant Liabilities for accounting purposes due to the currency of the exercise price being different from the
Corporation’s functional currency. The proceeds of the offering are required to be split between the Derivative Warrant Liabilities and the equity-classified Common Share at
the time of issuance of the Units. The fair value of the Derivative Warrant Liabilities at the time of issuance was determined to be $5.9 million and the residual of the proceeds
was allocated to the Common Shares. Total issuance costs related to this transaction totaled approximately $2.5 million. The issuance costs have been allocated between the
Warrants and Common Shares based on relative value. The portion allocated to the Warrants was recognized in finance costs in the Statements of Earnings and
Comprehensive Loss, whereas the portion allocated to Common Shares was recognized as a reduction to share capital, in the Statements of Financial Position.
The fair value of the public offering Warrants at issuance was estimated according to the Black-Scholes option pricing model and based on the following assumptions:
Exercise price
Share price
Risk-free interest
Estimated life (in years)
Expected volatility
December 27,
2017
US $1.26
US $0.97
2.22%
5
93.52%
The fair value of the public offering Warrants issued was determined to be $0.60 per warrant as at December 27, 2017. Changes in the fair value of the Warrants are
recognized in finance income or expenses.
As part of the transaction, the Corporation also issued broker warrants to purchase up to 495,050 Common Shares. Each broker warrant entitles the holder thereof to acquire
one Common Share of the Corporation at an exercise price of US$1.2625, at any time until December 27, 2022. The broker warrants are considered for compensation to non-
employees under IFRS 2, stock-based compensation, and are accounted for at fair value. To determine the fair value of the Broker Warrants, a Black-Scholes option pricing
model was used based on the following assumptions:
Exercise price
Share price
Risk-free interest
Estimated life (in years)
Expected volatility
The total cost associated with the Broker Warrants amounted to $406 and was recorded in contributed surplus.
F-27
December 27,
2017
US $1.2625
US $0.97
2.22%
5
93.52%
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
14.
(f)
Capital and Other Components of Equity (continued):
Public offering - February 21, 2017:
Concurrent with the private placement described in Note 12, 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. The proceeds and transaction costs were allocated to share capital.
As part of the transaction, the Corporation 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 Corporation’s 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 previous 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 a Black-Scholes option pricing model and based on the following assumptions:
Exercise price
Share price
Dividend
Risk-free interest
Estimated life (in years)
Expected volatility
$
$
February 21, 2017
2.15
1.70
-
0.79%
1.00
112.09%
The total cost associated with the Broker Warrants amounted to $144 and was recorded as contributed surplus.
(g)
Issuance of shares:
The following table summarizes the shares issued to settle the payment of accrued interest on the unsecured convertible debentures with the corresponding amount recorded to
share capital.
Accrued interest as at
March 31, 2017
June 30, 2017
September 30, 2017
December 31, 2017
March 31, 2018
June 30, 2018
September 30, 2018
Share issuance date
April 7, 2017
August 15, 2017
December 27, 2017
March 27, 2018
June 6, 2018
August 21, 2018
October 31, 2018
F-28
Number of shares
Amount
$
9,496
23,885
22,783
33,605
30,348
51,807
23,723
195,647
17
40
40
40
40
40
40
257
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
14.
(h)
Capital and other components of equity (continued):
Warrants:
The warrants of the Corporation are composed of the following as at March 31, 2019, March 31, 2018, March 31, 2017 and February 28, 2017:
March 31, 2019
March 31, 2018
March 31, 2017
Number
outstanding
Number
outstanding
Amount
$
Amount
$
Number
outstanding
Liability
May 2018 Public offering Warrants 2018 (i)
Series December 2017 US Public offering Warrants
10,188,100
8,246
-
-
2017 (ii)
9,801,861
8,017
9,802,935
6,405
-
-
Amount
$
-
-
February 28, 2017
(Unaudited)
Number
outstanding
Amount
$
-
-
Series 8 Public offering Warrants December 2013
(iii)
Equity
Public offering warrants
Public offering broker warrants May 2018 (iv)
Public offering U.S. broker warrants December 2017
(v)
Public offering warrants February 2017 (vi)
Private Placement- contingent warrants
2017 unsecured convertible debenture conversion
option and contingent warrants (vii)
Series 9 Private Placement warrants 2013 (viii)
Series 2017 BW Broker warrants (ix)
-
19,989,961
-
16,263
18,400,000
28,202,935
21
6,426
18,400,000
18,400,000
209
209
18,400,000
18,400,000
547,975
495,050
1,904,034
1,052,630
-
-
3,999,689
283
406
-
309
-
-
998
-
495,050
1,904,034
1,052,630
161,654
-
3,613,368
-
406
-
309
-
-
715
-
-
1,965,259
1,052,630
161,654
234,992
3,414,535
-
-
-
309
-
144
453
-
-
1,965,259
1,052,630
161,654
234,992
3,414,535
-
-
187
187
-
-
-
309
-
144
453
Warrant to acquire one Common Share of the Corporation at an exercise price of $1.31, expiring on May 9, 2023.
In order to obtain one Common Share of the Corporation at an exercise price of US$15.00, 10 warrants must be exercised. Warrants expired on December 3, 2018.
(i)
(ii) Warrant to acquire one Common Share of the Corporation at an exercise price of US$1.26, expiring on December 27, 2022.
(iii)
(iv) Warrant to acquire one Common Share of the Corporation at an exercise price of $1.05, expiring on May 9, 2023.
(v) Warrant to acquire one Common Share of the Corporation at an exercise price of US$1.2625, expiring on December 27, 2022.
(vi) Warrant to acquire one Common Share of the Corporation at an exercise price of $2.15, expiring on February 21, 2022.
(vii) 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. Exercisable only for any portion of or all
debentures paid by the Corporation prior to maturity.
(viii) Warrant to acquire one Common Share of the Corporation at an exercise price of $13.30, expired on December 3, 2018.
(ix) Warrant to acquire one Common Share of the Corporation at an exercise price of 2.15 expiring on February 21, 2018. 117,496 warrants amounted to $71 were exercised in November 2017 and
117,496 warrants expired on February 21, 2018
F-29
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
14.
(h)
Capital and other components of equity (continued):
Warrants (continued):
Warrants exercise:
During the year 771,400 warrants offered as part of the May 2018 public offering were exercised at an exercise price of $1.31 per Common Share of the Company, resulting
in $1.0 million of cash proceeds. In addition, 4,455 warrants offered as part of the December 2017 U.S. public offering were exercised in a cashless manner to acquire 1,074
Common Shares of the Company. A total of 772,474 Common Shares were issued as a result of 775,855 warrants being exercised. During the year ended December 31,
2017, 178,721 warrants offered as part of the February 2017 public offering were exercised at an exercise price of $2.15 per Common Share of the Company, resulting in
$384 of cash proceeds.
15.
Personnel expenses:
Salaries and other short-term employee benefits
Share-based compensation costs
Total personnel expenses
16.
Financial expenses:
Interest income
Foreign exchange gain (loss)
Interest payable on convertible debenture
Accretion of interest on convertible debenture
Transaction costs related to derivative warrant liabilities
Change in fair value of warrant liabilities
Other charges
Financial expenses
March 31,
2019
March 31,
2018
Thirteen-
months ended
March 31,
2017
$
4,144
1,041
5,185
$
3,281
929
4,210
$
2,491
674
3,165
Month ended
March 31,
2017
(Unaudited)
$
214
86
300
Twelve-month
period ended
February 28,
2017
(Unaudited)
$
2,277
588
2,865
March 31,
2019
March 31,
2018
Thirteen-
months ended
March 31,
2017
$
72
(32)
(160)
(206)
(1,134)
(344)
(4)
(1,808)
$
125
(180)
(17)
(22)
-
(53)
(19)
(166)
$
475
279
(160)
(205)
(653)
(6,287)
-
(6,551)
F-30
Month ended
March 31,
2017
(Unaudited)
$
Twelve-month
period ended
February 28,
2017
(Unaudited)
$
6
(3)
(14)
(17)
-
(22)
(1)
(51)
119
(177)
(3)
(5)
-
(31)
(18)
(115)
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
17.
Share-based payments:
At March 31, 2019, 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 (“Stock Option Plan”). An amendment of the Plan was
approved by shareholders on August 28, 2018. The amendment provides for an increase to the existing limits for Common Shares reserved for issuance under the Stock
Option Plan as well as certain changes to the minimum vesting period applicable to options granted to directors and employees under the Stock Option Plan. The plan
continues to provide for the granting of options to purchase Common Shares. The exercise price of the stock options granted under this amended 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. The maximum number of Common Shares that may be issued upon exercise
of options granted under the amended Stock Option Plan was increased from 2,940,511, representing 20% of the issued and outstanding Common Shares of the Company as
of March 31, 2017, to 5,494,209 representing 15% of the issued and outstanding Common Shares of the Company as of June 27, 2018. The terms and conditions for acquiring
and exercising options are set by the Corporation’s Board of Directors, subject among others, to the following limitations: the term of the options cannot exceed ten years and
(i) all options granted to a director will be vested evenly on a quarterly basis over a period of at least eighteen (18) months, and (ii) all options granted to an employee will be
vested evenly on a quarterly basis over a period of at least thirty-six (36) months.
The total number of shares issued to any one consultant within any twelve-month period cannot exceed 2% of the Corporation’s total issued and outstanding shares (on a non-
diluted basis). The Corporation is not authorized to grant within any twelve-month period such number of options under the stock option plan that could result in a number of
Common Shares issuable pursuant to options granted to (a) related persons exceeding 2% of the Corporation’s issued and outstanding 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 2% of the Corporation’s issued and outstanding 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:
Outstanding at beginning of year
Granted
Exercised
Forfeited
Expired
Outstanding at end of year
Exercisable at end of year
Outstanding at beginning of period
Granted
Forfeited
Expired
Outstanding at end of period
Weighted average
exercise price
$
1.81
0.77
0.77
1.84
-
1.25
March 31, 2019
Number of
options
Weighted average
exercise price
$
2.58
1.75
-
1.89
18.06
1.81
March 31, 2018
Number of
options
1,424,788
1,121,500
-
(199,800)
(62,100)
2,284,388
2,284,388
2,173,523
(4,167)
(407,067)
-
4,046,677
1.56
1,613,200
1.92
591,113
Thirteen-month period
ended
March 31, 2017
Number
of options
Weighted
average
exercise price
Month ended
March 31, 2017
Number
of options
Twelve-month period
ended
February 28, 2017
Number
of options
Weighted
average
exercise price
454,151
1,300,400
(190,138)
(139,625)
1,424,788
$
2.59
-
11.50
-
2.58
1,427,288
-
(2,500)
-
1,424,788
$
13.52
1.69
13.29
15.38
2.59
454,151
1,300,400
(187,638)
(139,625)
1,427,288
Weighted
average
exercise price
$
13.52
1.69
13.27
15.38
2.58
Exercisable at end of period
6.44
238,482
6.44
238,482
6.49
240,982
F-31
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
17.
(a)
Share-based payments (continued):
Corporation stock option plan (continued):
March 31,
2019
March 31,
2018
Thirteen-month
period ended
March 31,
2017
Twelve-month
Period ended
February 28, 2017
(Unaudited)
Weighted average fair value of the options granted to employees and directors
of the Corporation
$
0.51 $
1.22 $
1.40 $
1.40
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. 4,167
options were exercised during the period ended March 31, 2019 (nil for period ended March 31, 2018 and nil for the thirteen-month period ended March 31, 2017). Stock-
based compensation recognized under this plan for the period ended March 31, 2019 was $1,041 (March 31, 2018 amounted to $929, 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).
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:
Exercise price
Share price
Dividend
Risk-free interest
Estimated life (in years)
Expected volatility
March 31, 2019
March 31, 2018
Thirteen-month
period ended
March 31, 2017
Twelve-month
Period ended
February 28, 2017
(Unaudited)
$
$
$
$
0.77
0.73
-
2.10%
5.78
85.35
$
$
1.75
1.75
-
1.21%
5.89
82.4%
$
$
1.69
1.69
-
0.87%
4.94
123.5%
1.69
1.69
-
0.87%
4.94
123.5%
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.
The following tables summarize the status of the outstanding and exercisable options of the Corporation:
Exercise price
$0.77
$0.78
$1.59
$1.72
$1.89
- $0.77
- $1.58
- $1.71
- $1.88
- $6.50
Options outstanding
Exercisable options
March 31, 2019
Weighted remaining
contractual life
Number of options
Weighted average
exercise price
outstanding
outstanding
9.26
5.86
7.90
8.21
3.97
7.91
1,898,523 $
775,000 $
273,333 $
790,833 $
308,988 $
4,046,677 $
$
0.77
1.50
1.65
1.77
2.57
1.56
Number of options
exercisable
348,197
518,750
233,333
292,500
220,420
1,613,200
F-32
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
17.
(a)
Share-based payments (continued):
Corporation stock option plan (continued):
Share-based payment transactions and broker warrants:
The fair value of share-based payment transaction is measured using the Black-Scholes option pricing 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), 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, 2019 and March 31, 2018, and no stock-based compensation was recognized for the period ended March 31, 2019 and
March 31, 2018 (nil for the one-month and thirteen-month periods ended March 31, 2017).
18.
Loss per share:
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.
19.
(a)
Supplemental cash flow disclosure:
Changes in working capital items:
Receivables
Prepaid expenses
Other Assets
Deferred financing costs
Trade and other payables
Total changes in working capital items
March 31,
2019
March 31,
2018
Thirteen-
months ended
March 31,
2017
$
(553)
(103)
(659)
-
4,898
3,583
$
193
247
-
-
352
792
(738)
(709)
37
(179)
9,679
8,090
F-33
Month ended
March 31,
2017
(Unaudited)
$
Twelve-months
ended
February 28,
2017
(Unaudited)
$
(40)
(33)
-
-
(255)
(328)
233
280
-
-
607
1,120
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
19.
(b)
Supplemental cash flow disclosure (continued):
Non-cash transactions:
Issuance of shares for interest on convertible debt
Issuance of broker warrants included in net proceeds from
public offering
Public offering transaction costs included in trade and other
payables
Interest receivable included in receivables
Reduction in share issue costs from reduction in trade and
other payables
Private Placement transaction costs included in trade and
other payables
Equipment included in trade and other payables
Interest payable included in trade and other payables
Thirteen-months
ended
March 31,
March 31,
March 31,
2018
$
137
406
132
7
-
-
216
40
2017
$
94
144
381
-
109
40
288
18
2019
$
120
283
-
96
-
-
12
40
F-34
Month ended
March 31,
2017
(Unaudited)
$
-
Twelve-months
ended
February 28, 2017
(Unaudited)
$
94
-
381
-
-
40
288
18
144
416
-
109
50
269
4
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
20.
Income taxes:
Deferred tax (recovery) expense:
March 31,
2019
March 31,
2018
Thirteen-months
ended
March 31,
2017
$
$
$
Origination and reversal of temporary differences
Change in unrecognized deductible temporary differences
Deferred tax (recovery) expense
11,599
(11,599)
-
5,241
(5,241)
-
2,240
(2,369)
(129)
Reconciliation of effective tax rate:
Loss before income taxes
Basic combined Canadian statutory income tax rate 1
Computed income tax recovery
Increase resulting from:
Change in unrecognized deductible temporary
differences
Non-deductible stock-based compensation
Non-deductible change in fair value
Permanent differences and other
Change in statutory income tax rate
Total tax (recovery) expense
March 31,
2019
March 31,
2018
$
(51,566)
26.68%
(13,758)
$
(21,504)
26.78%
(5,759)
11,599
279
1,677
203
-
-
5,241
248
92
178
-
-
Thirteen-months
ended
March 31,
2017
$
(11,376)
26.87%
(3,057)
2,369
178
14
166
201
(129)
1 The Canadian combined statutory income tax rate has decreased due to a reduction in the provincial statutory income tax rate.
F-35
Month
ended
March 31,
2017
(Unaudited)
$
163
(163)
-
Twelve-months
ended
February 28,
2017
(Unaudited)
$
2,077
(2,206)
(129)
Month
ended
March 31,
2017
(Unaudited)
$
(769)
26.80%
(206)
Twelve-months
ended
February 28,
2017
(Unaudited)
$
(10,607)
26.88%
(2,851)
162
23
6
12
3
-
2,207
155
8
154
198
(129)
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
20.
Income taxes (continued):
Unrecognized deferred tax assets:
At March 31, 2019, 2018, and 2017, 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:
Deferred tax assets
Tax losses carried forward
Research and development expenses
Property, plan and equipment and intangible assets
Financing expenses
Other deductible temporary differences
Deferred tax assets
Deferred tax liabilities
Tax basis of unsecured convertible debentures in excess of carrying value
Deferred tax liabilities
Net deferred tax assets
March 31, 2019
$
March 31, 2018
$
March 31, 2017
$
23,695
5,362
766
1,852
378
32,053
13
13
32,040
12,670
4,927
567
116
768
19,048
67
67
18,981
8,293
4,220
435
-
522
13,470
122
122
13,348
On initial recognition of the unsecured convertible debenture equity component on February 21, 2017, 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, 2019, the amounts and expiry dates of tax attributes and temporary differences, which are available to reduce future years’ taxable income, were as follows:
Tax losses carried forward
2029
2030
2031
2032
2033
2034
2035
2036
2037
2038
2039
Research and development expenses, without time limitation
Other deductible temporary differences, without time limitation
F-36
Federal
$
714
1,627
2,071
2,262
1,854
3,598
4,595
5,494
8,584
17,340
41,447
89,586
19,617
30,875
March 31, 2019
Provincial
$
714
1,620
2,063
2,241
1,825
3,598
4,459
5,494
8,456
17,270
41,447
89,187
21,036
32,294
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
21.
Financial instruments:
This note provides disclosures relating to the nature and extent of the Corporation’s 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.
(a)
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. The Corporation has credit risk relating to cash and
cash equivalents and marketable securities, 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 Corporation’s credit exposure at the reporting date.
(b)
Currency risk:
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 Corporation's business transactions denominated in currencies other than the Canadian dollar. Fluctuations related to foreign exchange rates could cause
unforeseen fluctuations in the Corporation's 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. 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 Corporation’s significant foreign exchange currency exposures as stated in Canadian dollars at the following dates:
Denominated in
Cash and cash equivalents
Marketable securities
Receivables
Trade and other payables
The following exchange rates are those applicable to the following periods and dates:
CA$ per US$
CA$ per Euro
March 31, 2019
Euro
US
$
March 31, 2018
Euro
US
$
3,369
2,696
16
(13,251)
(7,170)
-
-
-
(131)
(131)
7,024
26
6
(3,924)
3,132
-
-
-
(627)
(627)
Average
March 31, 2019
Reporting
March 31, 2018
Reporting
Average
1.3122
1.5192
1.3349
1.4975
1.2834
1.5008
1.2900
1.5898
Based on the Corporation’s foreign currency exposures noted above, varying the above foreign exchange rates to reflect a 5% strengthening of the US dollar and Euro would
have an increase (decrease) in net loss as follows, assuming that all other variables remain constant:
Increase (decrease) in net loss
March 31, 2019
$
March 31, 2018
$
364
(88)
An assumed 5% weakening of the foreign currencies would have an equal but opposite effect on the basis that all other variables remained constant.
F-37
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
21.
(c)
Financial instruments (continued):
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.
The Corporation’s exposure to interest rate risk as at March 31, 2019 and March 31, 2018 is as follows:
Cash and cash equivalents
Marketable Securities
Unsecured convertible debentures
Short-term fixed interest rate
Short-term fixed interest rate
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.
(d)
Liquidity risk:
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 24. It also manages liquidity risk by continuously monitoring actual and projected cash flows.
The Board of Directors reviews and approves the Corporation's operating budgets, and reviews material transactions outside the normal course of business. Refer to Note 2(c).
The following are the contractual maturities of financial liabilities as at March 31, 2019 and March 31, 2018:
Required payments per year
Trade and other payables
Unsecured convertible debentures
Required payments per year
Trade and other payables
Unsecured convertible debentures
Notes
11
13
Notes
11
13
Total Carrying amount
$
$
Less than 1 year
$
16,429
2,143
18,572
16,429
1,817
18,246
16,429
2,143
18,572
March 31, 2019
1 to 3 years
$
-
-
-
Total Carrying amount
$
$
Less than 1 year
$
March 31, 2018
1 to 3 years
$
6,697
2,303
9,000
6,697
1,612
8,309
6,697
160
6,857
-
2,143
2,143
The Derivative warrant liabilities are excluded from the above tables as they expected to be settled in shares and not by the use of liquidities.
22.
Commitments and contingencies:
Research and development contracts and contract research organizations agreements:
The Corporation utilizes contract manufacturing organizations related to the development and production of clinical material and clinical research organizations to perform
services related to the Company’s clinical trials. Pursuant to these agreements with manufacturing and contract research organizations, the Corporation has the right to
terminate the agreements either without penalties or under certain penalty conditions. For agreements which contain penalty conditions, the Company would be required to
pay penalties of approximately $109.
During Fiscal 2018, the Corporation entered into a lease agreement, for its research and development and quality control laboratory facility located in Sherbrooke, Québec,
resulting in a commitment of $79 over the remaining lease term, which is committed in the next year.
Contingencies:
The Corporation evaluates contingencies on an ongoing basis and establishes loss provisions for matters in which losses are probable and the amount of the loss can be
reasonably estimated. Refer to Note 25, Subsequent Events.
F-38
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
23.
Determination of fair values:
Certain of the Corporation’s 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 (cash and cash equivalents, marketable securities and trade and other
payables) 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 March
31, 2019 approximates the carrying amount and was measured using level 3 inputs.
Derivative warrant liabilities:
The Corporation measured its derivative warrant liabilities at fair value on a recurring basis. These financial liabilities were measured using level 3 inputs (Note 12).
As at March 31, 2019, 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 $569 or a gain of $598, respectively.
As at March 31, 2019, the effect of a 5% strengthening of the US dollar, would result in a loss of $405. An assumed 5% weakening of the foreign currency would have an
equal but opposite effect on the basis that all other variables remained constant.
24.
Capital management:
Since inception, the Corporation’s 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 13).
Since the beginning of its operations, the Corporation has primarily financed its liquidity needs from funding provided through public offerings, private placements, from the
exercise of warrants that were distributed to its related party’s shareholders, from a rights offering and from the issuance of options to employees. The Corporation defines
capital to include total shareholders’ equity, derivative warrant liabilities and unsecured convertible debentures. The Corporation’s policy is to maintain a minimal level of
debt.
The following table summarizes the cash and cash equivalents of the Corporation:
Cash
Cash equivalents
Term deposits issued in CAD currency
Term deposits issued in US currency [US - $3,250]
Commercial papers issued in CAD currency
Commercial papers issued in US currency [US - $1,099]
Promissory notes issued in CAD currency
Promissory notes issued in US currency [US - $798]
Bankers acceptance
Total Cash equivalents
Total Cash and cash equivalents
F-39
March 31, 2019
$
1,896
March 31, 2018
$
1,583
12,100
-
5,693
-
498
-
2,334
20,625
22,521
-
4,193
-
1,418
-
1,029
6,640
8,223
ACASTI PHARMA INC.
Notes to Financial Statements
For the years ended March 31, 2019, 2018 and the thirteen-month and one-month periods ended March 31, 2017, and the twelve-month period ended February 28, 2017
(thousands of Canadian dollars, except where noted and for share and per share amounts)
24.
Capital management (continued):
As at March 31, 2019, the term deposits, commercial paper, promissory note and bankers acceptance have maturity dates of ranging between April 1, 2019 and June 25,
2019, bearing interest rates ranging from 1.76% and 2.40% per annum, cashable at any time at the discretion of the Corporation, under certain conditions.
As at March 31, 2018, the term deposits, commercial paper and promissory note have maturity dates of ranging between April 2, 2018 and May 11, 2018, bearing interest
rates ranging from 1.26% and 1.72% per annum, cashable at any time at the discretion of the Corporation, under certain conditions.
25.
Subsequent events
On April 15, 2019 the Corporation announced the annual grant of stock options to its employees, executives and directors of its stock option plan (the “Stock Option Plan”).
The stock options were granted by the Board of Directors as part of the Corporation’s annual performance review in accordance with the Corporation’s Long-Term Incentive
Program (LTIP). An aggregate of 644,117 stock options were granted to certain employees, executives and directors of the Corporation under the Corporation’s Stock Option
Plan. Subject to the terms and conditions of the Stock Option Plan, options granted to directors will vest in equal quarterly installments over a period of 18 months and options
granted to executives and employees will vest in equal quarterly installments over a period of 36 months. Each option will entitle the holder to purchase one common share of
the Corporation at a price of CDN$1.28, until April 15, 2029.
On May 10, 2019 the Corporation announced the settlement regarding legal claims made by its former chief executive (“CEO”) officer with respect to the termination of his
employment. Pursuant to the settlement agreement, the Corporation has agreed to issue 900,000 common shares at $1.10 per share to the former CEO. In addition, the
Corporation has agreed to reimburse the former CEO for legal fees of $64. Furthermore, pursuant to the settlement agreement, the Corporation receives a full and final release
from the former CEO on all procedures in connection with the termination of his employment. This settlement has been accrued as at March 31, 2019 and the expense of
$1,054 is included as part of General and administrative expenses.
F-40
Exhibit 4.6
Exhibit 4.7
SECTION 302 CERTIFICATION
Exhibit 12.1
I, Janelle D’Alvise, certify that:
1.
I have reviewed this annual report on Form 20-F of Acasti Pharma Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results
of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d–15(f)) for the company and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which
this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting
principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has
materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and
the audit committee of the company’s board of directors (or persons performing the equivalent functions):
a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect
the company’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
/s/ Jan D’Alvise
Name: Jan D’Alvise
Title: Principal Executive Officer
Date: June 26, 2019
Exhibit 12.2
I, Jean-François Boily, certify that:
1.
I have reviewed this annual report on Form 20-F of Acasti Pharma Inc.;
SECTION 302 CERTIFICATION
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results
of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d–15(f)) for the company and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which
this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting
principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has
materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and
the audit committee of the company’s board of directors (or persons performing the equivalent functions):
a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect
the company’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
/s/ Jean-François Boily
Name: Jean-François Boily
Title: Principal Financial Officer
Date: June 26, 2019
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES–OXLEY ACT OF 2002
In connection with the Annual Report on Form 20-F of Acasti Pharma Inc. (the “Company”) for the fiscal year ended March 31, 2019, as filed with the Securities and Exchange
Commission on the date hereof (the “Report”), I, Janelle D’Alvise, Principal Executive Officer of the Company certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, that:
1. The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Exhibit 13.1
Date: June 26, 2019
/s/ Jan D’Alvise
Name: Jan D’Alvise
Title: Principal Executive Officer
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES–OXLEY ACT OF 2002
In connection with the Annual Report on Form 20-F of Acasti Pharma Inc. (the “Company”) for the fiscal year ended March 31, 2019, as filed with the Securities and Exchange
Commission on the date hereof (the “Report”), I, Jean-François Boily, Principal Financial Officer of the Company certify pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
1. The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Exhibit 13.2
Date: June 26, 2019
/s/ Jean-François Boily
Name: Jean-François Boily
Title: Principal Financial Officer
Exhibit 15.1
KPMG LLP
600 de Maisonneuve Blvd. West
Suite 1500, Tour KPMG
Montréal (Québec) H3A 0A3
Canada
Telephone (514) 840-2100
(514) 840-2187
Fax
www.kpmg.ca
Internet
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors of Acasti Pharma Inc.
We consent to the incorporation by reference in the registration statements on Form S-8 (No. 333-191383 and No. 333-227476), and Form F-3 (No. 333-223464) of Acasti
Pharma Inc. of our report dated June 26, 2019, with respect to the statements of financial position as at March 31, 2019 and 2018, the related statements of earnings and
comprehensive loss, changes in equity and cash flows for the years ended March 31, 2019 and 2018 and the thirteen month period ended March 31, 2017, and the related notes,
which report appears in the annual report on Form 20-F of Acasti Pharma Inc. dated June 26, 2019.
Our report dated June 26, 2019 contains an explanatory paragraph that states that Acasti Pharma Inc. has incurred operating losses and negative cash flows from operations
since inception and additional funds will be needed in the future for activities necessary to prepare for commercial launch, which indicate that a material uncertainty exists that
casts substantial doubt about its ability to continue as a going concern. The financial statements do not include any adjustments that may be necessary if the going concern basis
was not appropriate.
Our report dated June 26, 2019 also contains an explanatory paragraph that states that the financial statements of Acasti Pharma Inc. for the twelve-month and one-month
periods ended February 28, 2017 and March 31, 2017 respectively are unaudited. Accordingly, we do not express an opinion on them.
June 26, 2019
Montréal, Canada
Exhibit 15.2
June 26, 2019
Acasti Pharma Inc.
545 Promenade du Centropolis, Suite 100
Laval, Québec
Canada H7T 0A3
Re: Consent of Destum Partners, Inc.
The Board of Directors of Acasti Pharma Inc.,
We hereby consent to the references to our name and the inclusion of information, data and statements from our market research reports with respect to CaPre, dated August 19,
2016 and November 17, 2017 (the “Reports”), as well as any citation of the Reports, in (i) Acasti Pharma Inc.’s (the “Company”) annual report on Form 20-F (“Annual
Report”) dated June 26, 2019 for its fiscal year ended March 31, 2019 and (ii) the Company’s registration statements on Form S-8 (No. 333-191383 and No. 333-227476), on
Form F-1 (No. 333-220755) and on Form F-3 (No. 333-223464).
We further hereby consent to the filing of this letter as an exhibit to the Annual Report.
In giving such consent, we do not thereby admit that we come within the category of persons whose consent is required under Section 7 of the U.S. Securities Act of 1933, as
amended, or the rules and regulations of the U.S. Securities and Exchange Commission thereunder.
Yours faithfully,
For and on behalf of
Destum Partners, Inc.
By:
/s/ Thomas J. Filipczak
Name: Thomas J. Filipczak
Title: Managing Director & Partner