Item 9A. Controls and Procedures
Item 9A. 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 chief executive officer (“CEO”) and chief financial officer (“CFO”), 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, 2022, our existing disclosure controls and procedures were effective. It should be noted that while the CEO and CFO 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 CFO, 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 our 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, 2022. 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, 2022, 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 year ended March 31, 2022 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting. The merger resulted in Grace being included in our current control environment over financial reporting as at the date of the completion of the business combination.
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 9B. Other Information
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
None.
54
PART III
Item 10. Directors, Executive Officers and Corporate Governance
The information required by this Item is included in the Company’s 2022 Proxy Statement to be filed with the SEC within 120 days after March 31, 2022 in connection with the solicitation of proxies for the Company’s 2022 annual meeting of shareholders, and is incorporated herein by reference.
Item 11. Executive Compensation Summary of our Compensation Programs
The information required by this Item is included in the Company’s 2022 Proxy Statement to be filed with the SEC within 120 days after March 31, 2022 in connection with the solicitation of proxies for the Company’s 2022 annual meeting of shareholders, and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters Equity Compensation Plan Information
The information required by this Item is included in the Company’s 2022 Proxy Statement to be filed with the SEC within 120 days after March 31, 2022 in connection with the solicitation of proxies for the Company’s 2022 annual meeting of shareholders, and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions and Director Independence Related Transactions
The information required by this Item is included in the Company’s 2022 Proxy Statement to be filed with the SEC within 120 days after March 31, 2022 in connection with the solicitation of proxies for the Company’s 2022 annual meeting of shareholders, and is incorporated herein by reference.
Item 14. Principal Accounting Fees and Services Audit Fees
The information required by this Item is included in the Company’s 2022 Proxy Statement to be filed with the SEC within 120 days after March 31, 2022 in connection with the solicitation of proxies for the Company’s 2022 annual meeting of shareholders, and is incorporated herein by reference.
55
PART IV
Item 15. Exhibits, Financial Statement Schedules
(a)(1) Financial Statements—The financial statements included in Item 8 are filed as part of this annual report on Form 10-K.
(a)(2) Financial Statement Schedules—All schedules have been omitted because they are not applicable or required, or the information required to be set forth therein is included in the consolidated Financial Statements or notes thereto included in Item 8 of this annual report on Form 10-K.
(a)(3) Exhibits—The exhibits required by Item 601 of Regulation S-K are listed in paragraph (b) below.
(b) Exhibits—The exhibits listed on the Exhibit Index below are filed herewith or are incorporated by reference to exhibits previously filed with the SEC.
Item 16. Form 10-K Summary
None.
56
EXHIBITS INDEX
Exhibit No.
Description
2.1
Agreement and Plan of Merger dated as of May 7, 2021 among Acasti Pharma Inc., Acasti Pharma U.S., Inc. and Grace Therapeutics Inc. (incorporated by reference to Exhibit 2.1 from Form 8-K filed with the SEC on May 7, 2021)
3.1
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)
3.2
Articles of Amendment (incorporated by reference to Exhibit 3.1 from Form 8-K filed with the SEC on August 27, 2021)
3.2
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)
3.3
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)
4.1
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)
4.2
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)
4.3
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)
4.4
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)
4.5
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)
4.6
Description of Securities
10.1
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)
10.2
Acasti Pharma Inc., Equity Incentive Plan, as amended August 27, 2020.
10.3
Acasti Pharma Inc., Stock Option Plan, as amended June 24, 2021.
10.4
Employment Agreement with Jan D’Alvise, dated May 11, 2015 (incorporated by reference to Exhibit 10.6 from Form F-1 (File No. 333- 220755) filed with the SEC on September 29, 2017)
10.5
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)
10.6
Employment Agreement with Brian Ford dated September 23, 2021.
23.1
Consent of KPMG LLP, an Independent Registered Public Accounting Firm.
31.1
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
31.2
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
32.1
Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2
Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
57
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
58
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: June 21, 2022
ACASTI PHARMA INC.
By:
/s/ Janelle D’Alvise
Name:
Janelle D’Alvise
Title: President and Chief Executive Officer and
Director (Principal Executive Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ Janelle D’Alvise
President and Chief Executive Officer and Director
June 21, 2022
Janelle D’Alvise
(Principal Executive Officer)
/s/ Brian Ford
Chief Financial Officer
June 21, 2022
Brian Ford
(Principal Financial Officer and Principal Accounting Officer)
/s/ Dr. Roderick N. Carter
Director
June 21, 2022
Dr. Roderick N. Carter
/s/ Jean-Marie (John) Canan
Director
June 21, 2022
Jean-Marie (John) Canan
/s/ Donald Olds
Director
June 21, 2022
Donald Olds
/s/Vimal Kavuru
Director
June 21, 2022
Vimal Kavuru
/s/William Haseltine
Director
June 21, 2022
William Haseltine
/s/Michael L.Derby
Director
June 21, 2022
Michael L.Derby
59
ACASTI PHARMA INC.
Consolidated Financial Statements
For the years ended March 31, 2022 and 2021
Consolidated Balance Sheets
F- 4
Consolidated Statements of Loss and Comprehensive Loss
F- 5
Consolidated Statements of Changes in Shareholders’ Equity
F- 6
Consolidated Statements of Cash Flows
F- 7
Notes to the Consolidated Financial Statements
F- 8
F- 1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Report of Independent Registered Public Accounting Firm
To the Shareholders and Board of Directors of Acasti Pharma Inc.:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Acasti Pharma Inc. (the "Company") as of March 31, 2022 and 2021, the related consolidated statements of loss and comprehensive loss, changes in shareholders’ equity, and cash flows for the years ended March 31, 2022 and 2021, and the related notes (collectively, the "consolidated financial statements"). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of March 31, 2022 and 2021, and the results of its operations and its cash flows for the years ended March 31, 2022 and 2021, in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated 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 consolidated 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.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated 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 consolidated 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 consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
KPMG LLP, an Ontario limited liability partnership and member firm of the KPMG global organization of independent
member firms affiliated with KPMG International Limited, a private English company limited by guarantee. KPMG
Canada provides services to KPMG LLP.
F- 2
Page 2
Valuation of in-process research and development intangible assets
As discussed in Note 4 to the consolidated financial statements, on August 27, 2021, the Corporation completed its acquisition of all outstanding equity interests in Grace Therapeutics Inc. The acquisition has been accounted for as a business combination using the acquisition method of accounting. The fair value of the purchase price was allocated to the assets acquired and liabilities assumed at their respective fair values. Intangible assets of $69,810 relate to the value of in-process research and development (“IPR&D”). Management estimated the fair value of the IPR&D intangible assets using a multi-period excess earnings method. The significant assumptions used in the valuation are the discount rate, the probability of clinical success of research and development programs and obtaining regulatory approval, and forecasted net sales.
We identified the assessment of the fair value of the IPR&D intangible assets as a critical audit matter. This required a high degree of auditor judgment and an increased extent of effort when performing procedures due to the measurement uncertainty related to the significant assumptions and the selection of the valuation methodology.
The following are the primary procedures we performed to address this critical audit matter. We evaluated the design of an internal control related to the valuation of IPR&D intangible assets process including the significant assumptions used in the valuation. We compared the assumptions related to probability of clinical success of research and development programs and obtaining regulatory approval to third-party data regarding clinical trial success rates. We assessed the forecasted net sales by comparing them to certain peer companies and/or industry data. We involved valuation professionals with specialized skills and knowledge, who assisted in:
• evaluating the valuation methodology by comparing to methodologies commonly used to value IPR&D intangible assets
• developing an independent range of discount rates and comparing it to the discount rate selected by management.
We have served as the Company’s auditor since 2009.
Montréal, Québec
June 21, 2022
F- 3
ACASTI PHARMA INC.
Consolidated Balance Sheets
March 31, 2022
March 31, 2021
(Expressed in thousands of U.S. dollars except share data)
Notes
$
$
Assets
Current assets:
Cash and cash equivalents
30,339
50,942
Short- term investments
6
13,322
9,789
Receivables
5
548
530
Assets held for sale
8
602
768
Prepaid expenses
720
343
Total current assets
45,531
62,372
Right of Use Asset
315
86
Intangible assets
4
69,810
—
Goodwill
4
12,964
—
Total assets
128,620
62,458
Liabilities and Shareholders’ equity
Current liabilities:
Trade and other payables
10
3,156
1,493
Lease liability
104
86
Total current liabilities
3,260
1,579
Derivative warrant liabilities
11, 12(b)
10
5,219
Lease Liability
191
—
Deferred tax liability
4
16,889
—
Total liabilities
20,350
6,798
Shareholders’ Equity:
Common shares
12
257,990
197,194
Additional paid-in capital
12
12,154
10,817
Accumulated other comprehensive loss
( 6,037
)
( 6,333
)
Accumulated deficit
( 155,837
)
( 146,018
)
Total Shareholder’s equity
108,270
55,660
Commitments and contingencies
20
Total liabilities and shareholders’ equity
128,620
62,458
The accompanying notes are an integral part of these consolidated financial statements
F- 4
ACASTI PHARMA INC.
Consolidated Statements of Loss and Comprehensive Loss
Year ended March 31, 2022
Year ended March 31, 2021
(Expressed in thousands of U.S. dollars except share data)
Notes
$
$
Revenues
Revenues from product sales
13
—
196
Operating Expenses
Cost of sales of products
—
( 76
)
Research and development expenses, net of government assistance
9
( 5,559
)
( 4,173
)
General and administrative expenses
( 9,263
)
( 5,521
)
Sales and marketing
( 518
)
( 1,142
)
Impairment of Intangible assets
7
—
( 3,706
)
Impairment of Equipment
8
—
( 1,584
)
Impairment of Other assets and prepaid
8
( 249
)
( 413
)
Loss from operating activities
( 15,589
)
( 16,419
)
Financial income (expenses)
14
5,122
( 3,259
)
Loss before income tax recovery
( 10,467
)
( 19,678
)
Income tax recovery
18
648
—
Net loss and total comprehensive loss
( 9,819
)
( 19,678
)
Basic and diluted loss per share
16
( 0.27
)
( 1.33
)
Weighted average number of shares outstanding
36,841,762
14,828,232
The accompanying notes are an integral part of these consolidated financial statements
F- 5
ACASTI PHARMA INC.
Consolidated Statements of Changes in Shareholders’ Equity
(Expressed in thousands of U.S. dollars except share data)
Common Shares
Notes
Number
Dollar
Additional
Paid-in
Capital
Accumulated
other
comprehensive
loss
Deficit
Total
$
$
$
$
$
Balance, March 31, 2021
26,046,950
197,194
10,817
( 6,333
)
( 146,018
)
55,660
Net loss and total comprehensive loss for the period
—
—
—
—
( 9,819
)
( 9,819
)
Cumulative translation adjustment
—
—
—
296
—
296
Stock based compensation
15
—
—
1,337
—
—
1,337
Common shares issued in relation to merger with Grace via share-for-share, net
4
18,241,233
60,796
—
—
—
60,796
Balance at March 31, 2022
44,288,183
257,990
12,154
( 6,037
)
( 155,837
)
108,270
Common Shares
Notes
Number
Dollar
Additional
Paid-in
Capital
Accumulated
other
comprehensive
loss
Deficit
Total
$
$
$
$
$
Balance, March 31, 2020
11,276,187
137,424
9,797
( 7,887
)
( 126,340
)
12,994
Net loss and total comprehensive loss for the period
—
—
—
—
( 19,678
)
( 19,678
)
Cumulative translation adjustment
—
—
—
1,554
—
1,554
Warrants exercised
11, 12
27,872
274
( 91
)
—
—
183
Net proceeds from shares issued under the at-the-market (ATM) program
12(b)
14,715,596
59,336
—
—
—
59,336
Stock based compensation
27,295
160
1,111
—
—
1,271
Balance at March 31, 2021
26,046,950
197,194
10,817
( 6,333
)
( 146,018
)
55,660
The accompanying notes are an integral part of these consolidated financial statements
F- 6
ACASTI PHARMA INC.
Consolidated Statements of Cash Flows
Year ended March 31, 2022
Year ended March 31, 2021
(Expressed in thousands of U.S. dollars except share data)
Notes
$
$
Cash flows used in operating activities:
Net loss for the year
( 9,819
)
( 19,678
)
Adjustments:
Amortization of intangible assets
7
—
781
Depreciation of equipment
8
—
143
Impairment of intangible assets
7
—
3,706
Impairment of Equipment
8
—
1,584
Impairment of other assets and prepaids
8
249
413
Stock-based compensation expense
15
1,337
1,174
Change in fair value of warrant liabilities
11
( 5,197
)
2,426
Write off-of deferred financing costs of at-the-market (ATM) program
—
264
Income tax recovery
18
( 648
)
Unrealized foreign exchange loss
( 370
)
814
Changes in non-cash working capital items
17
( 2,786
)
( 5,946
)
Net cash used in operating activities
( 17,234
)
( 14,319
)
Cash flows from (used in) investing activities:
Acquisition of equipment
6
—
( 69
)
Acquisition of short-term investments
( 34,929
)
( 9,810
)
Maturity of short-term investments
31,407
21
Net cash used in investing activities
( 3,522
)
( 9,858
)
Cash flows from (used in) financing activities:
Net proceeds from shares issued under the at-the-market (ATM) program
—
59,332
Deferred financing costs
—
( 143
)
Proceeds from exercise of warrants
—
183
Proceeds from exercise of stock options
—
118
Net cash from financing activities
—
59,490
Effect of exchange rate fluctuations on cash and cash equivalents
26
6,329
Translation effect on cash and cash equivalents related to reporting currency
127
( 4,940
)
Net (decrease) increase in cash and cash equivalents
( 20,603
)
36,702
Cash and cash equivalents, beginning of year
50,942
14,240
Cash and cash equivalents, end of year
30,339
50,942
Cash and cash equivalents are comprised of:
Cash
30,339
38,406
Cash equivalents
—
12,536
F- 7
ACASTI PHARMA INC.
Notes to the Consolidated Financial Statements
(Expressed in thousands of U.S. dollars except share data)
1. Nature of Operations
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 3009 boul. de la Concorde East, Suite 102, Laval, Québec, Canada H7E 2B5.
In January 2020 and August 2020, the Corporation released Phase 3 TRILOGY clinical study results for the Corporation’s lead drug candidate, CaPre. The TRILOGY studies did not meet the primary endpoint which resulted in the Corporation’s Board of Directors deciding not to proceed with a filing of an NDA with the FDA. With the completion of the TRILOGY studies beginning in the second half of fiscal 2021, marketing and research and development activities and expenses were reduced while management undertook a strategic review, and some CaPre related equipment and other assets were and continue to be classified as held for sale as they are expected to be sold.
In August 2021, the Corporation completed the acquisition via a share-for-share merger of Grace Therapeutics, Inc. (“Grace”) a privately held emerging biopharmaceutical company focused on developing innovative drug delivery technologies for the treatment of rare and orphan diseases. The post-merger Corporation is focused on building a late-stage specialty pharmaceutical company specializing in rare and orphan diseases and focused on developing and commercializing products that improve the standard of care using novel drug delivery technologies. The Corporation seeks to apply new proprietary formulations to existing pharmaceutical compounds to achieve enhanced efficacy, faster onset of action, reduced side effects, more convenient delivery and increased patient compliance; all of which could result in improved patient outcomes. The active pharmaceutical ingredients chosen by the Corporation for further development may be already approved in the target indication or could be repurposed for use in new indications.
The Corporation has incurred operating losses and negative cash flows from operations in each year since its inception. The Corporation expects to incur significant expenses and continued operating losses for the foreseeable future. The Corporation expects its expenses will increase substantially in connection with its ongoing activities, particularly as it advances clinical development for the first three drug candidates in the Corporation’s pipeline; continues to engage contract manufacturing organizations (“CMOs”) to manufacture its clinical study materials and to ultimately develop large-scale manufacturing capabilities in preparation for commercial launch; seeks regulatory approval for its product candidates; and adds personnel to support its product development and future product launch and commercialization.
The Corporation does not expect to generate revenue from product sales unless and until it successfully completes drug development and obtains regulatory approval, which the Corporation expects will take several years and is subject to significant uncertainty. To date, the Corporation has financed its operations primarily through public offerings and private placements of its common shares, warrants and convertible debt and the proceeds from research tax credits. Until such time that the Corporation can generate significant revenue from product sales if ever, it will require additional financing, which is expected to be sourced from a combination of public or private equity or debt financings or other non-dilutive sources, which may include fees, milestone payments and royalties from collaborations with third parties. Arrangements with collaborators or others may require the Corporation to relinquish certain rights related to its technologies or drug product candidates. Adequate additional financing may not be available to the Corporation on acceptable terms, or at all. The Corporation’s inability to raise capital as and when needed would have a negative impact on its financial condition and its ability to pursue its business strategy.
The Corporation remains subject to risks similar to other development stage companies in the biopharmaceutical industry, including compliance with government regulations, protection of proprietary technology, dependence on third party contractors and consultants and potential product liability, among others.
Reverse stock split
On August 26, 2021, the shareholders of the Corporation approved a resolution to undertake a reverse split of the common stock within a range of 1-6 to 1-8 with such specific ratio to be approved by the Acasti Board. All references in these financial statements to number of common shares, warrants and options, price per share and weighted average number of shares outstanding prior to the reverse split have been adjusted to reflect the approved reverse stock split of 1- 8 , which was made effective on August 31, 2021, on a retrospective basis as of the earliest period presented.
2. Summary of significant accounting policies
Basis of presentation
These consolidated financial statements of Acasti Pharma Inc., which include the accounts of its subsidiary have been prepared in accordance with U.S. GAAP. All intercompany transactions and balances are eliminated on consolidation.
Use of estimates
The preparation of the financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect 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 management 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.
Estimates and assumptions include the measurement of derivative warrant liabilities ( note 11 ) stock-based compensation ( note 15 )) assets held for sale (notes 8) the supply contract (note 20(a)) and acquisition of Grace and valuation of intangibles (note 4). Estimates and assumptions are also involved in measuring the accrual of services rendered with respect to research and developments expenditures at each reporting date, are determining which research and development expenses qualify for research and development 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.
Functional and reporting currency
The Corporation’s functional currency is the Canadian dollar. The effects of exchange rate fluctuations on translating foreign currency monetary assets and liabilities into Canadian dollars are included in the statement of loss and comprehensive loss as foreign exchange gain/loss. Expense transactions are translated into the U.S. dollar reporting currency at the average exchange rate during the period, and assets and liabilities are translated at end of period exchange rates, except for equity transactions, which are translated at historical exchange rates.
F- 8
Cash and Cash Equivalents
Cash and cash equivalents comprise cash balances and highly liquid investments purchased with original maturities of three months or less. Cash and cash equivalents consist of term deposits held at the bank and recorded at cost, which approximates fair value .
Investments
The Corporation’s investments consist of term deposits and are classified as held-to-maturity securities. These investments are recorded at amortized cost. Investments with original maturities exceeding three months and less than one year are categorized as short-term.
Receivables
Receivables are classified at amortized cost and recorded at the outstanding amount net of any provisions for uncollectible amount.
Deferred Financing Costs
Deferred financing costs consists of fees charged by underwriters, attorneys, accountants, and other fees directly attributable to future issuances of shares. Provided these costs are determined to be recoverable, these costs are deferred and charged subsequently against the gross proceeds of the related equity transaction when it occurs. If at such time, the Corporation deems that these costs are no longer recoverable, they will be expensed as a component of finance expenses.
Assets held for sale
Assets that are classified as held for sale are measured at the lower of their carrying amount or fair value less expected selling costs (“estimated selling price”) with a loss recognized to the extent that the carrying amount exceeds the estimated selling price. The classification is applicable at the date upon which the sale of assets is probable, and the assets are available for immediate sale in their present condition. Assets once classified as held for sale, are not subject to depreciation or amortization and both the assets and any liabilities directly associated with the assets held for sale are classified as current in the Corporation’s Consolidated Balance Sheets. Subsequent changes to the estimated selling price of assets held for sale are recorded as gains or losses to the Consolidated Statements of Income wherein the recognition of subsequent gains is limited to the cumulative loss previously recognized.
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 operating expenses in the Consolidated Statement of Loss and Comprehensive Loss.
(ii) Subsequent costs
The costs of the day-to-day servicing of equipment are recognized in profit or loss as incurred.
(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
Method
Rate
Furniture and office equipment
Declining balance
20
%
to
30
%
Computer equipment
Declining balance
30
%
Laboratory equipment
Declining balance
30
%
Production equipment
Declining balance
10
%
to
30
%
Depreciation methods, useful lives and residual values are reviewed periodically and adjusted prospectively if appropriate.
Goodwill and Intangible assets - acquired in-process research and development
In a business combination, the fair value of in-process research and development (“IPR&D”) acquired is capitalized and accounted for as indefinite-lived intangible assets, and not amortized until the underlying project receives regulatory approval, at which point the intangible assets will be accounted for as definite-lived intangible assets and amortized over the remaining useful life or discontinued. If discontinued, the intangible asset will be written off. Research and development (“R&D”) costs incurred after the acquisition are expensed as incurred.
The estimated fair values of identifiable intangible assets were determined using the multi-period excess earnings method, which is a valuation methodology that provides an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would generate over its remaining useful life. The significant assumptions used in the valuation are the discount rate, the probability of clinical success of research and development programs, obtaining regulatory approval and forecasted net sales.
Goodwill and indefinite-lived assets are not amortized but are subject to an impairment review annually and more frequently when indicators of impairment exist. An impairment of goodwill could occur if the carrying amount of a reporting unit exceeds the fair value of that reporting unit. An impairment of indefinite-lived intangible assets would occur if the fair value of the intangible asset is less than the carrying value.
F- 9
The Corporation tests its goodwill for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If the Corporation concludes it is more likely than not that fair value of the reporting unit is less than its carrying amount, a quantitative impairment test is performed.
The Corporation tests indefinite-lived intangible assets for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If the Corporation concludes it is more likely than not that the fair value is less than it's carrying amount, a quantitative impairment test is performed. There were no triggering events from the date of acquisition of Grace to the end of the year with respect to goodwill and indefinite-lived intangible assets. The Corporation's annual impairment test will be performed in the third quarter of the fiscal year.
An impairment of $ 3,706 was recognized in the year ended March 31, 2021. The Corporation no longer has recognized amortizable patents and licenses.
Amortization group
Amortization is calculated over the cost of the intangible asset less its residual value. Amortization is recognized in profit or loss on a straight-line basis over the estimated useful lives of intangible assets from the date that they are available for use, since this most closely reflects the expected pattern of consumption of the future economic benefits embodied in the asset. T he estimated useful lives for the current and comparative periods are as follows:
Assets
Period (years)
Patents
20
License
8 to 14
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.
Impairment of Long-Lived Assets
The Corporation reviews the recoverability of its long-lived assets whenever events or changes in circumstances indicate that it is carrying amount may not be recoverable. The carrying amount is first compared with the undiscounted cash flows. If the carrying amount is higher than the sum of undiscounted cash flows, then the Corporation determines the fair value of the underlying asset group. Any impairment loss to be recognized is measured as the difference by which the carrying amount of the asset group exceeds the estimated fair value of the asset group. An impairment of $ 1,584 for equipment was recognized in the year ended March 31, 2021.
Research and Development Costs
Research and developments expenditures are expensed as incurred. These costs primarily consist of employees’ salaries and benefits related to research and development activities, contractors and consultants that conduct the Corporation’s clinical trials, independent auditors and consultants to perform investigation activities on behalf of the Corporation, laboratory material and small equipment, clinical trial materials, stock-based compensation expense, and other non-clinical costs and regulatory fees. Advance payments for goods and services that will be used in future research and development are recognized in prepaids or other assets and are expensed when the services are performed, or the goods are used.
Stock based compensation
The Corporation has in place a stock option plan for directors, officers, employees, and consultants of the Corporation, with grants under the stock option plan approved by the Corporation’s Board of Directors. The plan provides for the granting of options to purchase Common Shares and the exercise price of each option equals the closing trading price of Common Shares on the day prior to the grant. The terms and conditions for acquiring and exercising options are set by the Corporation’s Board of Directors in accordance with and subject to the terms and conditions of the stock option plan. The Corporation measures the cost of such awards based on the fair value of the award at grant date, net of estimated forfeiture, and recognizes stock-based compensation expense in the Consolidated Statements of Loss and Comprehensive Loss on a graded vesting basis over the requisite service period. The requisite service period equals the vesting periods of the awards. The fair value of options is estimated for each tranche of an award that vests on a graded basis. The fair value of options is estimated using the Black-Scholes option pricing model, which uses various inputs including estimated fair value of the Common Shares at the grant date, expected term, estimated volatility, risk-free interest rate and expected dividend yields of the Common Shares. The Corporation applies an estimated forfeiture rate derived from historical employee termination behaviour. If the actual forfeitures differ from those estimated by management, adjustment to compensation expense may be required in future periods.
Non-employee stock-based compensation transactions in which the Corporation receives goods or services as consideration for its own equity instruments are accounted for as stock-based compensation transactions. The Corporation establishes the fair value at the grant date for non-employee awards and measures the fair value based on the fair value of equity instruments issued. The fair value of a non-employee award is estimated using the Black-Scholes option pricing model, which uses various inputs including estimated fair value of the Common Shares at the grant date, contractual term, estimated volatility, risk-free interest rate and expected dividend yields of the Common Shares.
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.
Leases
At the inception of an arrangement, the Corporation determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Operating lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Corporation utilizes its incremental borrowing rate to discount lease payments, which reflects the fixed rate at which the Corporation could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. .
F- 10
The Corporation has elected not to recognize leases with an original term of one year or less on the balance sheet. The Corporation typically only includes an initial lease term in its assessment of a lease arrangement. Options to renew a lease are not included in the Corporation’s assessment unless there is reasonable certainty that the Corporation will renew. The Corporation’s lease expense is recognized in research and development expenses. The Corporation does not have financing leases.
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 (tax base) of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. Deferred tax assets and liabilities are measured at the tax rate expected to apply when the underlying asset or liability is realised (settled) based on the rates that are enacted at the reporting date. Deferred tax assets and liabilities are offset if the Corporation has the right to set off the amount owed by with the amount owed by the other party, the Corporation intends to set off and the offset right is enforceable at law. A deferred tax asset is recognized for unused tax losses and tax credits, reduced by a valuation allowance to the extent that it is more likely than not that some portion or all of the deferred tax asset will not be realized.
Earnings per share
The Corporation presents basic and diluted earnings per share ( EPS ) data for its Common Shares. Basic EPS is calculated by dividing the profit or loss attributable to the holders of Common Shares by the weighted average number of Common Shares outstanding during the year. Diluted EPS is determined by adjusting the profit or loss attributable to the holders of Common Shares and the weighted average number of Common Shares outstanding adjusted for the effects of all dilutive potential Common Shares, which comprise warrants and share options granted to employees.
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 patent portfolio and licensed rights. The majority of the Corporation’s assets are located in Canada and the United States, while one production unit, which is classified as an asset held for sale, with a carrying value of $ 157 ( March 31, 2021 - $ 156 ), is located in France at a third-party contract manufacturing facility.
Derivative financial instruments
The Corporation has issued warrants of which some are accounted for as 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 financial expenses.
Other equity instruments
Warrants that do not meet the definition of a liability instrument are recognized in equity as additional paid in capital.
Fair Value Measurements
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, short-term investments and trade and other payables) approximate their fair value given the short-term nature of these instruments. The Corporation measured its derivative warrant liabilities at fair value on a recurring basis using level 3 inputs .
3. Recent Accounting Pronouncements
The Corporation has considered recent accounting pronouncements and concluded that they are either not applicable to the business or that the effect is not expected to be material to the consolidated financial statements as a result of future adoption.
4. Acquisition of Grace
On August 27, 2021, the Corporation completed its acquisition of all outstanding equity interests in Grace Therapeutics Inc, via a merger. Grace, based in New Jersey and organized under the laws of Delaware, was a rare and orphan disease specialty pharmaceutical company.
In connection with the share-for-share noncash transaction, Grace was merged with a new wholly owned subsidiary of Acasti and became a subsidiary of Acasti. As a result, Acasti acquired Grace’s entire therapeutic pipeline consisting of three unique clinical stage and multiple pre-clinical stage assets supported by an intellectual property portfolio consisting of various granted and pending patents in various jurisdictions worldwide. Under the terms of the acquisition, each issued and outstanding share of Grace common stock was automatically converted into the right to receive Acasti common shares equal to the equity exchange ratio set forth in the merger agreement.
F- 11
Consideration for acquisition
A total of 18,241,233 common shares of Acasti have been issued to Grace stockholders as consideration for the acquisition.
Total common shares issued
18,241,233
Acasti share price (closing share price on August 27, 2021)
$
3.3344
Fair value of common shares issued
$
60,824
The acquisition of Grace has been accounted for as a business combination using the acquisition method of accounting. The fair value of the purchase price was allocated to the assets acquired and liabilities assumed at their respective fair values. Management estimated the fair value of the IPR&D intangible assets using a multi-period excess earnings method. The significant assumptions used in the valuation are the discount rate, the probability of clinical success of research and development programs, obtaining regulatory approval and forecasted net sales. This acquisition method requires, among other things, that assets acquired, and liabilities assumed in a business combination be recognized at their fair values as of the acquisition date. The valuation of assets acquired, and liabilities assumed has been finalized during the fourth quarter of 2022.
Measurement period adjustments to the preliminary purchase price allocation during 2022 included (i) an increase to intangible assets of $ 4,602 ; (ii) an increase to goodwill of $ 12,964 ; (iii) an increase to deferred tax liability of $ 17,536 ; and (iv) other individually insignificant adjustments to identifiable net assets of $ 30 . The measurement period of adjustments primarily resulted from the completion of the valuation of the intangible assets based on facts and circumstances that existed as of the acquisition date and did not result from intervening events subsequent to such date.
The following table summarizes the final fair value of assets acquired and liabilities assumed as of the acquisition date:
$
Assets acquired and liabilities assumed
Cash and equivalents
90
Prepaid expenses and other current assets
74
Intangible assets – in-process research and development
69,810
Goodwill
12,964
Accounts payable and accrued expenses
( 4,578
)
Deferred tax liability
( 17,536
)
Total assets acquired and liabilities assumed
60,824
Intangible asse ts of $ 69,810 relate to the value of IPR&D, related to Grace’s therapeutic pipeline, consisting of three unique clinical stage programs/assets supported by intellectual property, the value of which has been attributed as follows:
$
Intangible assets – in-process research and development
GTX 104
27,595
GTX 102
31,908
GTX 101
10,307
Total
69,810
Management estimated the fair value of the IPR&D intangible assets using a multi-period excess earnings method. The significant assumptions used in the valuation are the discount rate, the probability of clinical success of research and development programs, obtaining regulatory approval and forecasted net sales.
Goodwill of $ 12,964 was calculated as the excess of the consideration transferred over the net assets recognized and represents the future economic benefits arising from the other assets acquired that could not be indiv idually identified and separately recognized. A deferred tax liability of $ 17,536 related to the identified intangible assets resulted.
Acquisition-related expenses, which were comprised primarily of regulatory, financial advisory and legal fees, totalled $ 3.2 million for the year ended March 31, 2022 and were included in general and administrative expenses in the consolidated statements of loss and comprehensive loss. The net loss attributed to Grace in the consolidated statement of income (loss), since the date of acqui sition is $ 1,505 .
Pro forma financial information
The following table presents the unaudited pro forma combined results of Acasti and Grace for the year ended March 31, 2022, as if the acquisition of Grace had occurred on April 1, 2020:
Year ended March 31, 2022
$
Net loss
( 13,734
)
The unaudited pro forma condensed combined financial information was prepared using the acquisition method of accounting and was based on the historical financial information of Acasti and Grace. The unaudited pro forma financial information is not necessarily indicative of what the consolidated results of operations would have been had the acquisition been completed on April 1, 2020. In addition, the unaudited pro forma financial information is not a projection of future results of operations of the combined company, nor does it reflect the realization of any synergies or cost savings associated with the acquisition.
F- 12
5. Receivables
March 31, 2022
March 31, 2021
Notes
$
$
Sales tax receivables
184
160
Government assistance
9
353
339
Interest receivable
11
13
Other receivables
—
18
Total receivables
548
530
6. Short-term Investments
The Corporation holds various short term investments with maturities greater than 3 months at the time of purchase as follows:
March 31, 2022
March 31, 2021
$
$
Term deposits issued in US currency earning interest at 0.20 % and maturing on April 1, 2022
11,893
7,542
Term deposits issued in CAD currency earning interest at ranges between 0.50 % and 0.58 % and maturing on various dates from April 1, 2022 to March 30,2023
1,429
2,247
Total short-term investments
13,322
9,789
7. Impairment loss Intangible assets
In prior years, the Corporation entered into agreements with Neptune Wellness Solutions Inc. ("Neptune") pursuant to which the Corporation obtained a license and exercised its option under the license agreement to pay in advance future royalties payable to Neptune. This license allowed the Corporation to exploit the intellectual property rights in order to conduct clinical trials for its CaPre drug candidate. During the second quarter of fiscal 2021, the Corporation released its Phase 3 clinical programs data and its failure to meet its primary endpoints, and the resulting decision to not file an NDA to obtain FDA approval for CaPre and therefore undertook an analysis to determine the fair value of the intangible asset.
In assessing the magnitude of any impairment of the license the Corporation considered all available evidence, including (i) significant adverse impact from business climate due to the Phase 3 clinical program’s failure to meet its primary endpoints, and the resulting decision to not file an NDA to obtain FDA approval for CaPre, and the resulting internal forecasts that no cash flows from the use of the license was possible, and (ii) management’s estimate that a market place participant would place minimal to no value on the license if it were to be sold on its own or in combination with other assets, recognized or not, which is a level 3 measurement in the fair value hierarchy which included unobservable inputs. Accordingly, an impairment loss of $ 3,706 was recognized in the second quarter of the year ended March 31, 2021, which represents the totality of the intangible assets net book value prior to the impairment trigger. For the year ended March 31, 2021 amortization expense, prior to the impairment was $ 781 and was included in research and development expenses.
8. Assets held for sale
During the period the Corporation committed to a plan and is actively marketing for sale Other assets and Equipment and has met the criteria for classification of assets held for sale:
March 31, 2022
March 31, 2021
$
$
Other assets (a)
195
387
Equipment (b)
407
381
602
768
a. Other assets
Other assets represent krill oil (RKO) held by the Corporation that was expected to be used in the conduct of R&D activities and commercial inventory scale up related to the development and commercialization of the CaPre drug. Given that the development of CaPre will no longer be pursued, the Corporation is expected to sell this reserve. The other asset is being recorded at the fair value less costs to sell, which has resulted in an impairment loss of $ 249 (2021 - $ 413 ). Management’s estimate of the fair value of the RKO less cost -to sell, is based primarily on estimated market prices obtained from an appraiser specialized in the krill oil market. These projections are based on Level 3 inputs of the fair value hierarchy and reflect management’s best estimate of market participants’ pricing of the assets as well as the general condition of the asset. The total impairment loss recognized, includes amounts paid for krill oil in advance, but not yet received and was recorded as a prepaid.
b. Equipment
March 31, 2022
Cost, net of impairment
Accumulated
depreciation
Net book
value
$
$
$
Furniture and office equipment
17
( 5
)
12
Computer equipment
94
( 6
)
88
Laboratory equipment
585
( 435
)
150
Production equipment
1,179
( 1,022
)
157
1,875
( 1,468
)
407
F- 13
March 31, 2021
Cost
Accumulated
depreciation
Impairment
loss
Net book
value
$
$
$
$
Furniture and office equipment
17
( 5
)
—
12
Computer equipment
148
( 30
)
( 54
)
64
Laboratory equipment
756
( 436
)
( 171
)
149
Production equipment
2,538
( 1,023
)
( 1,359
)
156
3,459
( 1,494
)
( 1,584
)
381
For the year ended March 31, 2021, depreciation expense was $ 143 and was included in research and development expenses. Equipment is made up of Laboratory, Production, Computer and Office equipment that was utilized in the development of CaPre. Given that the development of CaPre will no longer be pursued, the Corporation is expected to sell this equipment. Similarly, to the intangible assets, the announcement of the outcomes of the TRILOGY clinical trials resulted in an impairment trigger for the laboratory and production equipment. The impairment loss is based on management’s estimate of the fair value of the equipment less cost -to sell, which is based primarily on estimated market prices obtained from brokers specialized in selling used equipment. These projections are based on Level 3 inputs of the fair value hierarchy and reflect the Corporations best estimate of market participants’ pricing of the assets as well as the general condition of the assets.
9. Government assistance
March 31, 2022
March 31, 2021
$
$
Investment tax credit
353
339
Government assistance is comprised of a government grant from the Canadian federal government and research and development investment tax credits receivable from the Quebec 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. For the years ended March 31, 2022 and 2021 , the Corporation recorded $ 577 and $ 127 , respectively, as a reduction of research and development expenses in the Consolidated Statements of Loss and Comprehensive Loss.
The amounts recorded as receivables are subject to a government tax audit and the final amounts received may differ from those recorded. Unrecognized Canadian federal tax credits may be used to reduce future Canadian federal income tax and expire as follows:
$
2029
9
2030
23
2031
36
2032
345
2033
353
2034
348
2035
415
2036
229
2037
252
2038
259
2039
355
2040
370
2041
146
2042
191
3,331
In September 2019, the Corporation was awarded up to CAD $ 750 in non-dilutive and non-repayable funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to apply towards eligible research and development disbursements of the Corporation’s unique commercial production platform for CaPre. As at March 31, 2022 and 2021 the Corporation has claimed nil and $ 79 in connection with this program, which has been recorded as a reduction of research and development expenses in the Consolidated Statements of Loss and Comprehensive Loss.
In October 2020, the Corporation received correspondence from the NRC IRAP that the eligible amount awarded to the Corporation for non-dilutive and non-repayable funding was reduced from up to CAD $ 750 to up to CAD $ 326 .
10. Trade and other payables
March 31, 2022
March 31, 2021
$
$
Trade payables
1,678
115
Accrued liabilities and other payables
296
607
Employee salaries and benefits payable
1,182
771
Total trade and other payables
3,156
1,493
11. Derivative warrant liabilities
In connection with the Canadian public offering of units consisting of common shares and warrants that closed on May 9, 2018, the Corporation issued a total of 1,369,937 warrants. Each warrant entitles the holder thereof to acquire one common share at an exercise price of CAD $ 10.48 at any time until May 9, 2023. The warrants issued are derivative warrant liabilities given the warrant indenture contains certain contingent provisions that allow for cash settlement.
In connection with the U.S. public offering units consisting of common shares and warrants that closed on December 27, 2017, the Corporation issued a total of 1,225,366 warrants. Each warrant entitles the holder thereof to acquire one common share at an exercise price of $ 10.08 at any time until December 27, 2022. The warrants issued are derivative warrant liabilities given the currency of the exercise price is different from the Corporation’s functional currency.
F- 14
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:
Warrants issued May 2018
Warrants issued December 27, 2017
March 31,
2022
March 31,
2021
March 31,
2022
March 31,
2021
$
$
$
$
Balance – beginning of year
2,597
1,146
2,622
1,247
Change in fair value
( 2,580
)
1,252
( 2,622
)
1,174
Translation effect
( 7
)
199
—
201
Balance – end of year
10
2,597
—
2,622
Fair value per warrant issuable
0.01
3.15
—
2.97
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
March 31,
2022
March 31,
2021
March 31,
2022
March 31,
2021
$
$
$
$
Exercise price
CAD $ 10.48
CAD $ 10.48
USD $ 10.08
USD $ 10.08
Share price
CAD $ 1.54
CAD $ 6.08
USD $ 1.22
USD $ 4.80
Risk-free interest
2.39
%
1.39
%
2.41
%
0.92
%
Contractual life (years)
1.11
2.11
0.74
1.74
Expected volatility
81.56
%
156.00
%
85.94
%
171.12
%
The Corporation measured its derivative warrant liabilities at fair value on a recurring basis. These financial liabilities were measured using level 3 inputs (see Note 11) .
As at March 31, 2022 , 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 have a nominal impact.
12. Capital and other components of equity
a. Common Shares
Authorized capital stock
Unlimited number of shares
➣ Class A shares (Common Shares), voting ( one vote per share), participating and without par value.
➣ 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 per share. 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 CAD $ 0.80 per share, subject to certain conditions. There are no ne issued and outstanding.
➣ Class C shares, non-voting, non-participating, without par value and maximum annual non-cumulative dividend of 5 % on the amount paid per share. 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 CAD $ 0.20 per share, subject to certain conditions. There are no ne issued and outstanding.
➣ Class D and E shares, they are non-voting, non-participating, without par value and maximum monthly non-cumulative dividend between 0.5 % and 2 % on the amount paid per share. 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 no ne issued and outstanding.
“At-the-market” sales agreement
On February 14, 2019, the Corporation entered into an “at-the-market” (ATM) sales agreement with B. Riley FBR, Inc. (“B. Riley”) pursuant to which the Common Shares may be sold from time to time for aggregate gross proceeds of up to $ 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 has a 3 -year term and requires the Corporation to pay between 3 % and 4 % commission to B. Riley based on volume of sales made.
On June 29, 2020, the Corporation entered into an amended and restated sales agreement (the Sales Agreement) with B. Riley, Oppenheimer& Co. Inc. and H.C. Wainwright & Co., LLC (collectively, the “Agents”) to amend the existing ATM program. Under the terms of the Sales Agreement, which has a three-year term, the Corporation may issue and sell from time to time its common shares (the Shares) having an aggregate offering price of up to US $ 75,000,000 through the Agents. Subject to the terms and conditions of the Sales Agreement, the Agents will use their commercially reasonable efforts to sell the Shares from time to time, based upon the Corporation’s instructions. The Corporation has no obligation to sell any of the Shares and may at any time suspend sales under the Sales Agreement. The Corporation and the Agents may terminate the Sales Agreement in accordance with its terms. Under the terms of the Sales Agreement, the Corporation has provided the Agents with customary indemnification rights and the Agents will be entitled to compensation, at a commission rate equal to 3.0 % of the gross proceeds from each sale of the Shares.
On November 10, 2021, the Corporation filed a prospectus supplement relating to its at-the-market program with B. Riley, Oppenheimer& Co. Inc. and H.C. Wainwright & Co., LLC acting as agents. Under the terms of the ATM Sales Agreement and the prospectus supplement, the Corporation may issue and sell from time-to-time common shares having an aggregate offering price of up to $ 75,000,000 through the agents. 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. The volume and timing of sales under the ATM program, if any, will be determined at the sole discretion of the Corporation’s board of directors and management. Costs incurred relating to prospectus supplement were $ 198 and are included
F- 15
in General and administrative expenses. For the year ended March 31, 2022 , no common shares were sold under the ATM program.
For the year ended March 31, 2021 , $ 14.7 million common shares were sold for total net proceeds of approximately $ 59.3 million. Commission, legal and costs related to share sale amounted to $ 2.0 million. The shares were sold at the prevailing market prices, which resulted in an average price of approximately $ 4.16 per share. Accordingly, proportional costs of $ 18 related to the common shares sold, were reclassified from deferred financings costs to equity. Total costs incurred to register the Sales Agreements were initially recorded as deferred financing costs in the Consolidated Balance Sheet. As at March 31, 2021, the remaining balance of the costs incurred of $ 264 were written off to financing expenses.
b. Warrants
The warrants of the Corporation are composed of the following:
March 31, 2022
March 31, 2021
Number
outstanding
Amount
Number
outstanding
Amount
$
$
Liability
May 2018 public offering warrants 2018 (i)
824,218
10
824,218
2,597
Series December 2017 U.S. public offering warrants 2017 (ii)
884,120
—
884,120
2,622
1,708,338
10
1,708,338
5,219
Equity
Public offering warrants
Public offering U.S. broker warrants December 2017 (iii)
32,390
161
32,390
161
Public offering warrants February 2017 (iv)
—
—
215,491
631
32,390
161
247,881
792
(i) Warrants to acquire one common share at an exercise price of CAD $ 10.48 , expiring on May 9, 2023.
(ii) Warrants to acquire one common share at an exercise price of $ 10.08 , expiring on December 27, 2022 .
(iii) Warrants to acquire one common share at an exercise price of $ 10.10 , expiring on December 19, 2022.
(iv) Warrants to acquire one common share at an exercise price of CAD $ 17.20 , expired on February 21, 2022.
During the year ended March 31, 2022 , no warrants were exercised. During the year ending March 31, 2021, 222,975 broker warrants offered as part of the May 2018 public offering were exercised at a price of $ 0.83 per Common Share of the Company, resulting in $ 183 of cash proceeds.
13. Revenues
In October 2020, the Corporation entered into an agreement with the Centre Integre Universitaire et des services sociaux de L’Estrie - Centre hospitalier Universitaire de Sherbrooke to start producing and selling Viral transport medium tubes to be utilized in testing related to the Covid-19 pandemic. Revenue is recognized when the product is received by the customer.
14. Net financial income (expenses)
March 31, 2022
March 31, 2021
$
$
Foreign exchange gain (loss)
( 299
)
( 676
)
Write-off of deferred financing fees related to at-the-market (ATM) program
—
( 264
)
Interest income
77
107
Other income
147
—
Change in fair value of warrant liabilities
5,197
( 2,426
)
Financial income (expenses)
5,122
( 3,259
)
15. Stock based compensation
At March 31, 2021, the Corporation has the following stock-based compensation arrangement:
a. Corporation stock option plan
The Corporation has in place a stock option plan for directors, officers, employees, and consultants of the Corporation. An amendment of the stock option plan was approved by shareholders on August 26, 2021. The amendment provides for an change to the existing limits for Common Shares reserved for issuance under the Stock Option Plan.
The Stock Option 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 common shares 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 shall not exceed 10% of the aggregate number of issued and outstanding shares of the Corporation. This resulted in an increase from 1,816,735 representing 15 % of the issued and outstanding common shares as of August 26, 2020, to 4,428,818 representing 10% of the issued and outstanding common shares as of March 31, 2022 . 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 monthly basis over a period of at least twelve (12) 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 Common 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
F- 16
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:
Number of
options
Weighted average
exercise price
Weighted average
grant date
fair value
CAD $
CAD $
Outstanding, March 31, 2020
1,241,611
7.97
6.62
Granted
—
—
—
Exercised
( 30,220
)
4.93
3.73
Forfeited
( 299,520
)
7.16
5.90
Expired
—
—
—
Outstanding, March 31, 2021
911,871
8.33
6.96
Granted
2,115,400
2.04
1.75
Exercised
—
—
—
Forfeited
( 37,890
)
4.00
3.06
Expired
—
—
—
Outstanding, March 31, 2022
2,989,381
3.94
3.32
Exercisable at end of year
989,911
7.45
6.19
March 31, 2022
March 31, 2021
Weighted average fair value of the options granted to employees and directors of the Corporation-
1.75
—
Compensation expense recognized under the stock option plan is summarized as follows:
March 31, 2022
March 31, 2021
$
$
Research and development expenses
447
353
General and administrative expenses
842
828
Sales and marketing expenses
48
( 7
)
1,337
1,174
As of March 31, 2022, there was C AD $ 1,794 (March 31, 2021 – CAD $ 476 ) of total unrecognized compensation cost, related to non-vested share options, which is expected to be recognized over a remaining weighted average vesting peri od of 1.36 year s (March 31, 2021 - 1.03 years).
A summary of the non-vested stock option activity and related information for the Corporation’s stock options granted is as follows:
Number of
options
Weighted average
grant date fair value
CAD ($)
Non- vested, March 31, 2021
283,637
5.97
Options granted
2,115,400
1.75
Options vested
( 369,672
)
4.15
Options forfeited and cancelled
( 29,895
)
1.93
Non- vested, March 31, 2022
1,999,470
1.91
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:
March 31, 2022
Weighted average- CAD
Exercise price
$ 1.75 CAD
Share price
$ 2.04 CAD
Dividend
—
Risk-free interest
1.48
%
Estimated life (years)
5.77
%
Expected volatility
120.65
%
F- 17
The following tables summarize information about activities within the stock option plan:
March 31, 2022
Exercise
price CAD
Weighted average
remaining contractual
life
Number of options
outstanding
Number of options
exercisable
$
1.64
—
$
1.84
9.88
37,500
—
$
1.85
—
$
3.15
9.62
2,050,399
190,701
$
3.16
—
$
5.20
8.00
298,376
211,095
$
5.21
—
$
8.20
6.26
190,819
190,819
$
8.21
—
$
11.36
7.04
206,445
191,454
$
11.37
—
$
12.84
1.11
65,625
65,625
$
12.85
—
$
13.68
4.90
13,542
13,542
$
13.69
—
$
15.04
5.20
90,313
90,313
$
15.05
—
$
38.40
1.05
36,362
36,362
8.62
2,989,381
989,911
Stock-based compensation payment transactions and broker warrants
The fair value of stock-based compensation transactions 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 for a duration equal to the weighted average life of the instruments, life based on the average of the vesting and contractual periods for employee awards as minimal prior exercises of options in which to establish historical exercise experience; contractual life for broker warrants), and the risk-free interest rate (based on government bonds). Service and performance conditions attached to the transactions, if any, are not considered in determining fair value. The expected life of the stock options 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.
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 ( RSUs ), performance share units, restricted shares, deferred share units and other stock-based awards, subject to restricted conditions as may be determined by the Board of Directors. There were no such awards outstanding as of March 31, 2022, and March 31, 2021 , and no stock-based compensation was recognized for the period ended March 31, 2022 and March 31, 2021 .
16. 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, as the Corporation has incurred losses in each of the periods presented. All outstanding options, RSUs and warrants could potentially be dilutive in the future.
17. Supplemental cash flow disclosure
a. Changes in working capital items:
March 31, 2022
March 31, 2021
$
$
Receivables
( 18
)
58
Prepaid expenses
( 380
)
672
Trade and other payables
( 2,388
)
( 6,701
)
Other assets
—
25
Total changes in working capital items
( 2,786
)
( 5,946
)
18. Income taxes
Income tax (recovery) expense:
March 31, 2022
March 31, 2021
$
$
Current tax (recovery) expense
—
—
Deferred tax (recovery) expense
( 648
)
—
Income tax (recovery) expense
( 648
)
—
F- 18
Reconciliation of effective tax rate:
March 31, 2022
March 31, 2021
$
$
Loss before income taxes
( 10,467
)
( 19,678
)
Basic combined Canadian statutory income tax rate 1
26.50
%
26.50
%
Computed income tax recovery
( 2,774
)
( 5,215
)
Increase resulting from:
Difference in foreign tax rates
( 77
)
—
Non-deductible stock-based compensation
354
311
Non-deductible change in fair value of warrants
( 1,377
)
643
Non-deductible transaction costs
697
—
Non-refundable Federal ITC
( 349
)
—
Change in valuation allowance
2,864
4,271
Other – Foreign exchange
12
( 10
)
Other
2
—
Total tax (recovery) expense
( 648
)
—
1 The Canadian combined statutory income tax rate has decreased due to a reduction in the provincial statutory income tax rate.
Net deferred income tax assets as of March 31, 2022, and 2021 were comprised of the following:
March 31, 2022
March 31, 2021
$
$
Deferred tax assets
Tax losses carried forward
35,683
28,753
Research and development expenses
5,828
5,424
Property, plan and equipment
688
933
Financing expenses
674
1,167
Licenses
118
—
Tax credit carry forwards
3,331
2,968
Other temporary differences
80
86
Deferred tax assets
46,402
39,331
Deferred tax liabilities
Property, plan and equipment and intangible assets
( 20,890
)
—
Deferred tax liabilities
( 20,890
)
—
Valuation allowance
( 42,401
)
( 39,331
)
Net deferred tax liabilities
( 16,889
)
—
As at March 31, 2022, the amounts and expiry dates of tax attributes and temporary differences, which are available to reduce future years’ taxable income, were as follows:
March 31, 2022
Federal
Provincial
United States
$
$
$
Tax losses carried forward
2028
571
571
2029
1,301
1,296
2030
1,656
1,650
2031
1,809
1,792
2032
1,483
1,460
2033
2,877
2,877
2034
3,675
3,565
2035
4,394
4,394
2036
6,465
6,366
2037
400
396
2038
13,866
13,811
2039
32,399
32,356
2040
23,558
23,421
2041
13,988
13,988
2042
10,910
10,910
No expiry
13,288
Total
119,352
118,854
13,288
Research and development expenses, without time limitation
21,127
23,125
Unrecognized tax benefits
The Corporation does not expect a significant change to the amount of unrecognized tax benefits over the next 12 months. However, any adjustments arising from certain ongoing examinations by tax authorities could alter the timing or amount of taxable income or deductions, of the allocation of income among tax jurisdictions, and these adjustments could differ from the amount accrued. The Corporation’s federal and provincial income tax returns filed for all years remain subject to examination by the taxation authorities.
F- 19
19. Financial instruments
a. Concentration of credit risk
Financial instruments that potentially subject the Corporation to a concentration of credit risk consist primarily of cash and cash equivalents and investments. Cash and cash equivalents and investments are all invested in accordance with the Corporation’s Investment Policy with the primary objective being the preservation of capital and the maintenance of liquidity, which is managed 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. Foreign 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 Corporations functional currency of the Canadian dollar. Fluctuations related to foreign exchange rates could cause unforeseen fluctuations in the Corporation's operating results. The Corporation does not use derivative instruments to hedge exposure to foreign exchange risk. The fluctuation of the U.S. dollar in relation to the Canadian dollar and other foreign currencies will consequently have an impact upon the Corporation’s net loss.
The operating results and financial position of the Corporation are reported in U.S. dollars (reporting currency) in the Corporation’s financial statements.
c. Liquidity risk
Liquidity risk is the risk that the Corporation will encounter difficulty in meeting the obligations associated with its financial liabilities that are settled by delivering cash or another financial asset. The Corporation manages liquidity risk through the management of its capital structure and financial leverage. 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. The Corporation currently does not have long-term debt nor arranged committed sources of financing and is operating via use of existing cash and short-term investment balances. Refer to Note 1 – Nature of Operations.
The Corporation’s financial liabilities obligations include trade and other payables, which fall due within the next 12 months in addition to the warrant derivatives that fall due beyond 12 months and are likely to be settled by the Corporation’s equity.
20. Commitments and contingencies
Research and development contracts and contract research organizations agreements
We utilize contract manufacturing organizations, for the development and production of clinical materials and contract research organizations to perform services related to our clinical trials. Pursuant to the agreements with these contract manufacturing organizations and contract research organizations, we have either the right to terminate the agreements without penalties or under certain penalty conditions.
Supply contract
On October 25, 2019, the Corporation signed a supply agreement with Aker Biomarine Antartic. (“Aker”) to purchase raw krill oil product for a committed volume of commercial starting material for CaPre for a total fixed value of $ 3.1 million. As at March 31, 2022 , the remaining balance of the commitment with Aker amounts to $ 2.8 mil lion. As of March 31, 2022, the remaining balance of the raw krill oil product has not been made available for delivery by the supplier under the terms of the supply agreement, therefore no liability has been recorded. Acasti no longer has any planned use for the raw krill oil product for its own operating purposes and therefore would seek to sell the product upon receipt. There is uncertainty as to whether the Corporation can recover value from the raw krill oil product and expects it may incur a loss on this contract in the near term.
Sherbrook Lease
On March 14, 2022, we renewed the lease agreement effective April 1, 2022, for our research and development and quality control laboratory facility located in Sherbrooke, Québec, resulting in a commitment of $ 556 over a 24 months base lease term and 48 months additional lease renewal term. As this is effective subsequent to year-end the renewal is not recorded in the financial statements.
Legal proceedings and disputes
In the ordinary course of business, the Corporation is at times subject to various legal proceedings and disputes. The Corporation assesses its liabilities and contingencies in connection with outstanding legal proceedings utilizing the latest information available. Where it is probable that the Corporation will incur a loss and the amount of the loss can be reasonably estimated, the Corporation records a liability in its consolidated financial statements. These legal contingencies may be adjusted to reflect any relevant developments. Where a loss is not probable or the amount of loss is not estimable, the Corporation does not accrue legal contingencies. While the outcome of legal proceedings is inherently uncertain, based on information currently available, management believes that it has established appropriate legal reserves. Any incremental liabilities arising from pending legal proceedings are not expected to have a material adverse effect on the Corporation’s financial position, results of operations, or cash flows. However, it is possible that the ultimate resolution of these matters, if unfavorable, may be material to the Corporation’s financial position, results of operations, or cash flows. No reserves or liabilities have been accrued as at March 31, 2022 .
21. Subsequent events
Functional currency
On April 1, 2022, the Corporation’s functional currency was changed from the Canadian dollar to the US dollar. This change will be reflected prospectively in the Corporation’s financial statements beginning with the first quarter of fiscal 2023.
Common shares
Subsequent to March 31, 2022, the Corporation sold an additional 151,575 common shares for net proceeds of approximately $ 146 (gross proceeds of $ 151 ) under the ATM program.
F- 20
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.