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MANAGEMENT DISCUSSION AND ANALYSIS OF THE FINANCIAL SITUATION AND OPERATING RESULTS - YEARS ENDED FEBRUARY 29, 2016 AND FEBRUARY 28, 2015 AND 2014
This management discussion and analysis ("MD&A") is presented in order to provide the reader with an overview of the financial results and changes to the financial position of Acasti Pharma Inc. ("Acasti" or the "Corporation") as at February 29, 2016 and for the year then ended. This MD&A explains the material variations in the financial statements of operations, financial position and cash flows of Acasti for the years ended February 29, 2016 and February 28, 2015 and 2014. The Corporation effectively commenced active operations with the transfer of an exclusive worldwide license from its parent corporation, Neptune Technologies & Bioressources Inc. ("Neptune"), in August 2008.
This MD&A, completed on May 25, 2016, must be read in conjunction with the Corporation's audited financial statements for the years ended February 29, 2016 and February 28, 2015 and 2014. The Corporation's audited financial statements were prepared in accordance with International Financing Reporting Standards ("IFRS"), as issued by the International Accounting Standards Board. The Corporation's 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.
Additional information on the Corporation can be found on the SEDAR website at www.sedar.com and on the EDGAR website at www.sec.gov/edgar.shtml under Acasti Pharma Inc.
The Class A shares of the Corporation are listed for trading on the TSX Venture Exchange under the ticker symbol "APO" and on the NASDAQ Capital Market exchange, under the symbol "ACST".
Forward-Looking Statements
This MD&A contains certain information that may constitute 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 Acasti refers to in this MD&A 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 MD&A includes, but is not limited to, information or statements about:
Although the forward-looking information is based upon what Acasti believes are reasonable assumptions, no person should place undue reliance on such information since actual results may vary materially from the forward-looking information.
In addition, the forward-looking information is subject to a number of known and unknown risks, uncertainties and other factors, including those described in this MD&A under the heading "Risk Factors", many of which are beyond the Corporation's control, that could cause the Corporation's actual results and developments to differ materially from those that are disclosed in or implied by the forward-looking information, including, without limitation:
Consequently, all the forward-looking information is qualified by this cautionary statement and there can be no guarantee that the results or developments that the Corporation anticipates will be realized or, even if substantially realized, that they will have the expected consequences or effects on the Corporation's business, financial condition or results of operations. Accordingly, you should not place undue reliance on the forward-looking information. Except as required by applicable law, Acasti does 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 MD&A.
Caution Regarding Non-IFRS Financial Measures
The Corporation uses adjusted financial measures, including Non-IFRS operating loss (loss from operating activities before interest, taxes, depreciation and amortization), to assess its operating performance. These non-IFRS financial measures are directly derived from the Corporation's financial statements and are presented in a consistent manner. The Corporation uses these measures for the purposes of evaluating its historical and prospective financial performance, as well as its performance relative to competitors. These measures also help the Corporation to plan and forecast for future periods as well as to make operational and strategic decisions. The Corporation believes that providing this information to investors, in addition to IFRS measures, allows them to see the Corporation's results through the eyes of management, and to better understand its historical and future financial performance.
Securities regulations require that companies caution readers that earnings and other measures adjusted to a basis other than IFRS do not have standardized meanings and are unlikely to be comparable to similar measures used by other companies. Accordingly, they should not be considered in isolation. The Corporation uses Non-IFRS operating loss to measure its performance from one period to the next without the variation caused by certain adjustments that could potentially distort the analysis of trends in our operating performance, and because the Corporation believes it provides meaningful information on the Corporation financial condition and operating results. Acasti's method for calculating Non-IFRS operating loss may differ from that used by other corporations.
Acasti calculates its Non-IFRS operating loss measurement by adding to net loss, finance costs, depreciation and amortization, impairment loss and by subtracting finance income. Other items that do not impact core operating performance of the Corporation are excluded from the calculation as they may vary significantly from one period to another. Finance income/costs include foreign exchange gain (loss) and change in fair value of derivative warrant liabilities. Acasti also excludes the effects of certain non-monetary transactions recorded, such as stock-based compensation, from its Non-IFRS operating loss calculation. The Corporation believes it is useful to exclude this item as it is a non-cash expense. Excluding this item does not imply it is necessarily non-recurring.
A reconciliation of net loss to Non-IFRS operating loss is presented later in this document.
Acasti is an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment of certain cardiometabolic disorders, in particular abnormalities in blood lipids, also known as dyslipidemia. Krill is a major source of phospholipids and polyunsaturated fatty acids, mainly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are two types of omega-3 fatty acids well known to be beneficial for human health.
Pursuant to a license agreement entered into with Neptune in August 2008, Acasti has been granted a license to rights on Neptune's intellectual property portfolio related to cardiovascular pharmaceutical applications (the "License Agreement"). In December 2013, the Corporation entered into a prepayment agreement with Neptune pursuant to which the Corporation exercised its option under the License Agreement to pay in advance all of the future royalties payable under the license in fiscal 2014. The royalty- free license allows Acasti to exploit the intellectual property rights in order to develop novel active pharmaceutical ingredients ("APIs") into commercial products for the medical food and the prescription drug markets. Acasti is responsible for carrying out the research and development of the APIs, as well as required regulatory submissions and approvals and intellectual property filings relating to the cardiovascular applications. The products developed by Acasti require the approval of the FDA before clinical studies are conducted and approval from similar regulatory organizations before sales are authorized.
CaPre , Acasti's prescription drug candidate, is a highly purified omega-3 phospholipid concentrate derived from krill oil and is being developed to treat severe hypertriglyceridemia, a condition characterized by abnormally very high levels of triglycerides in the bloodstream. In 2011, two Phase II clinical trials in Canada were initiated and now completed (TRIFECTA trial and COLT trial) to evaluate the safety and efficacy of CaPre for the management of mild to severe hypertriglyceridemia (high triglycerides with levels ranging from 200 to 877 mg/dL). Both trials also include the secondary objective of evaluating the effect of CaPre in patients with mild to moderate hypertriglyceridemia (high triglycerides levels ranging from 200 to 499 mg/dL) as well as in patients with severe hypertriglyceridemia (very high triglycerides levels ranging from 500 to 877 mg/dL). The open-label COLT trial was completed during the second quarter of fiscal 2014 and the TRIFECTA trial was completed in the second quarter of fiscal 2015. Based on the positive results of these trials, Acasti filed an investigational new drug submission to the U.S. Food and Drug Administration to conduct a pharmacokinetic study in the U.S. Acasti subsequently received approval to conduct this trial and it was completed in the second quarter of fiscal 2015.
Due to a decision by the FDA not to grant authorization to commercialize a competitor's drug in the mild to moderate patient population before the demonstration of clinical outcome benefits, Acasti is reassessing its clinical strategy and primarily focusing on the severe hypertriglyceridemia population.
Onemia , Acasti's commercialized product, has been marketed in the United States since 2011 as a medical food supplement and a natural health product (NHP) in Canada since 2012. An NHP is the equivalent of a dietary supplement in the US. Onemia is only administered in the U.S. under the supervision of a physician and is intended for the dietary management of omega-3 phospholipid deficiency related to abnormal lipid profiles and cardiometabolic disorders.
As previously disclosed, Acasti decided to find strategic alternatives for Onemia and focus its energy and resources on the development of CaPre . Acasti has entered into a non-exclusive licensing agreement for Onemia with Neptune in which Neptune has to engage in best commercial efforts to expand the marketing of Onemia . Acasti will receive a royalty of 17.5% on net sales of Onemia and Acasti believes given Neptune's sales and marketing leadership in the krill oil market that Neptune represents the best partner for Onemia . As of February 29, 2016, no sales have been realized by Neptune.
During the year, Acasti announced that the Japanese, Taiwanese and Mexican patent offices have each granted Acasti a composition and use patent. The patents are all valid until 2030 and relate to concentrated therapeutic phospholipid omega-3 compositions covering methods for treating or preventing diseases associated with cardiovascular diseases, metabolic syndrome, inflammation, neurodevelopmental diseases, and neurodegenerative diseases. They are in addition to multiple other patents that Acasti has been granted in the United States, Australia, Mexico, Saudi Arabia, Panama, and South Africa for phospholipid composition. As well, similar patent applications are being pursued in many jurisdictions worldwide. During the same period, the Chinese Patent Office also granted Acasti a composition and use patent. The Patent (ZL 201080059930.4), which is valid until 2030, relates also to concentrated therapeutic phospholipid omega-3 compositions.
The granting of these patents is a value-enhancing milestone, which further heightens the potential commercial implications, including possible licensing and partnership opportunities for CaPre . Acasti is committed to building a global portfolio of patents to ensure a long-lasting and comprehensive protection, while also safeguarding valuable market expansion opportunities.
During the year ended February 29, 2016, Acasti made progress in its research and pharmaceutical product development, advancing with its prescription drug candidate, CaPre .
CaPre - Clinical Trials Update
The TRIFECTA trial, a 12-week, randomized, placebo-controlled, double-blind, dose-ranging trial, was designed to assess the safety and efficacy of CaPre , at a dose of 1 or 2 g, on fasting plasma triglycerides as compared to a placebo in patients with mild to severe hypertriglyceridemia. A total of 387 patients were randomized and 365 patients completed the 12-week study, in line with the targeted number of evaluable patients. From this patient population, approximately 90% had mild to moderate hypertriglyceridemia with baseline triglycerides between 200 and 499 mg/dL (2.28 to 5.69 mmol/L). The remainder had very high baseline triglycerides between 500 and 877 mg/dL (> 5.7 and < 10 mmol/L). Approximately 30% of patients were on lipid lowering medications, such as statins, and approximately 10% were diabetic.
Similar to the COLT trial, the primary objective of the TRIFECTA trial was to evaluate the effect of CaPre on fasting plasma triglycerides in patients with triglycerides between 2.28 and 10.0 mmol/L (200-877 mg/dL) and to assess the tolerability and safety of CaPre . The secondary objectives of the TRIFECTA trial were to evaluate the effect of CaPre on fasting plasma triglycerides in patients with triglycerides between 2.28 and 5.69 mmol/L (200-499 mg/dL); to evaluate the dose dependent effect on fasting plasma triglycerides in patients with triglycerides > 5.7 and <10 mmol/L (500-877 mg/dL); and to evaluate the effect of CaPre in patients with mild to moderate hypertriglyceridemia and severe hypertriglyceridemia on fasting plasma levels of LDL-C (direct measurement), and on fasting plasma levels of HDL-C, non-HDL-C, hs-CRP and omega-3 index.
In Fiscal 2016, the Corporation received the full data for its TRIFECTA trial which confirmed and supported the positive Phase II TRIFECTA results announced in September 2014, on the safety and efficacy of CaPre in the treatment of patients with hypertriglyceridemia. The TRIFECTA trial's primary endpoint was met, with patients on 1 g or 2 g of CaPre achieving a statistically significant mean placebo-adjusted decrease in triglycerides from baseline. In addition, benefits in other key cholesterol markers were announced, including slight increases in HDL-C (good cholesterol), no deleterious effect on LDL-C (bad cholesterol) and no safety concerns.
During the same period, Acasti announced top-line results for its PK trial. The PK trial was an open-label, randomized, multiple-dose, single-center, parallel-design study in healthy volunteers. Forty-two male and female individuals, at least 18 years of age, were enrolled into three groups of 14 subjects who took 1, 2 or 4 grams of CaPre , administered once a day 30 minutes after breakfast. The objectives of the study were to determine the pharmacokinetic profile and safety on Day 1 following a single oral dose and Day 14 following multiple oral doses of CaPre on 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 pharmacokinetic parameters.
CaPre pharmacokinetics appear to be approximately dose-proportional over the 1 to 4 gram a day dose range. Following a single daily dose, CaPre reached steady state (EPA and DHA levels plateaued) within seven days of dosing. The bioavailability of CaPre was not significantly reduced when taken with a low-fat meal versus high-fat meal; a significant advantage for the management of hypertriglyceridemic patients on low fat diets. CaPre was safe and well tolerated, with no safety concerns.
Following receipt of data for the Phase I PK Study and the Phase II clinical trials - COLT and TRIFECTA - Acasti provided a data package to the FDA to receive direction on requirements for the pivotal Phase III clinical program.
Acasti is now corresponding with the FDA about the next steps proposed for the clinical development plan of CaPre . Such correspondence is meant to allow the FDA to provide feedback on Acasti's plans and to clarify or answer specific questions that the FDA may have prior to such next steps toward the pivotal Phase III clinical program. Such correspondence can take the form of written correspondence, discussions and potential in person meetings with the FDA.
Acasti intends to conduct a Phase III clinical trial in the United States, with potentially a few Canadian clinical trial sites, in a patient population with very high triglycerides (> or = 500 mg/dL). In addition to conducting a Phase III clinical trial, Acasti expects that additional time and capital will be required to complete the filing of a New Drug Application ("NDA") to obtain FDA approval for CaPre in the United States before reaching commercialization, which may initially be only for the treatment of severe hypertriglyceridemia.
Acasti intends to pursue the regulatory pathway for CaPre under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act and conduct a pivotal bioavailability bridging study, comparing CaPre to an omega-3 prescription drug as a means of establishing a scientific bridge between the two. This will help determine the feasibility of a 505(b)(2) regulatory pathway, while also optimizing the protocol design of a Phase III clinical program. The 505(b)(2) approval pathway has been used by many other companies and Acasti's regulatory and clinical experts believe such a strategy is best for CaPre . This should allow Acasti to further optimize the advancement of CaPre while benefiting most importantly from the substantial clinical and nonclinical data already available with another FDA-approved omega-3 prescription drug. In addition, this should reduce the expected expenses and streamline the overall CaPre development program required to support a NDA submission.
The finalization and execution of Acasti's comprehensive Capre development plan and definitive Phase III program, overall costs and timelines are contingent upon FDA review and direction. Acasti has recently received a response from the FDA on the CaPre clinical development program. With this endorsement Acasti has submitted an amendment to its current IND application to commence a bioavailability bridging study, while continuing to work closely with the FDA to ensure the Corporation is aligned with their views on Capre 's clinical development.
As planned, Acasti initiated and recently completed subject enrollment for the bioavailability bridging study. Acasti is expecting results of the study before the end of the year which should confirm Acasti's chosen regulatory pathway
Additional Developments
On April 29, 2015, Acasti announced the departure of Mr. Andr Godin from the Corporation. On August 5, 2015, Acasti announced the appointment of Mr. Mario Paradis as Chief Financial Officer of the Corporation.
On November 7, 2014 Acasti received notification from the NASDAQ Listing Qualifications Department for failing to maintain a minimum bid price of US$1.00 per share for 30 consecutive business days. To regain compliance, Acasti's shares had to close at US$1.00 per share or more for a minimum of ten (10) consecutive business days. The Corporation was able to cure the listing requirement violation during the fiscal year ended February 29, 2016.
On September 29, 2015, Acasti announced a compliance plan to meet the NASDAQ Minimum Bid Price Rules, by consolidating the issued and outstanding Class A common shares of the Corporation.
The reverse split became effective at the open of trading on October 14, 2015 and the Common Shares began trading on NASDAQ and TSX on a reverse split-adjusted basis on such date. There were currently 106,616,262 Common Shares issued and outstanding on a pre-Consolidation basis, which resulted into approximately 10,661,626 Common Shares issued and outstanding on a post-Consolidation basis.
The exercise price in effect on October 14, 2015, in the case of incentive stock options, warrants and other securities convertible into Common Shares, was increased proportionally to reflect the reverse split. The number of Common Shares subject to a right of purchase upon the exercise of convertible securities was also decreased proportionally to reflect the reverse split.
All share information for current and comparative periods presented in this MD&A has been adjusted to give effect to the reverse split described above.
On March 1, 2016, Acasti announced the resignations of Jerald D. Wenker, Harlan W. Waksal, Adrian Montgomery and Reed V. Tuckson as directors of the Corporation effective February 29, 2016. At the same date, Acasti announced the appointment of Dr. Roderick Carter as Executive Chairman of the Board and Pierre Fitzgibbon as director of the Corporation.
On March 22, 2016, Acasti received a Nasdaq Deficiency Letter confirming that the Corporation is no longer in compliance with NASDAQ Listing Rule 5605, requiring a company's audit committee to be comprised of atleast three independent directors. Consistent with Listing Rule 5605 (c) (4), NASDAQ has granted Acasti a cure period to regain compliance with the audit committee membership requirements no later than August 29, 2016. Acasti intends to satisfy the listing rule requirements by electing the new Board of Directors on July 12, 2016.
On May 12, 2016, Acasti appointed Ms. Jan D'Alvise as President and Chief Executive Officer effective June 1, 2016.
Basis of presentation of the financial statements
The Corporation's current assets of $11,325 as at February 29, 2016 include cash and short-term investments for an amount of $10,470, mainly generated by the net proceeds from the public and private offerings of common shares and warrants, completed on December 3, 2013 and February 7, 2014, respectively. The Corporation's liabilities at February 29, 2016 are comprised primarily of amounts due to creditors for $1,126 as well as derivative warrant liabilities of $156, which represents the fair value as at February 29, 2016, of the warrants issued to the Corporation's public offering participants. The Warrants forming part of the Units are derivative liabilities ("Derivative warrant liabilities") for accounting purposes due to the currency of the exercise price being different from the Corporation's functional currency. The warrant liabilities will be settled in Class A common shares. The fair value of the Warrants issued was determined to be $0.58 per warrant upon issuance and $0.09 per warrant as at February 29, 2016. The fair value of the Warrants is revalued at each reporting date.
The Corporation is subject to a number of risks associated with the successful development of new products and their marketing, the conduct of its clinical studies and their results, the meeting of development objectives set by Neptune in its license agreement, and the establishment of strategic alliances. The Corporation has incurred significant operating losses and negative cash flows from operations since inception. To date, the Corporation has financed its operations through public offering and private placement of common shares, funds from its parent corporation, proceeds from exercises of warrants, rights and options and research tax credits. To achieve the objectives of its business plan, the Corporation plans to establish strategic alliances and raise the necessary capital. It is anticipated that the products developed by the Corporation will require approval from the U.S Food and Drug Administration and equivalent organizations in other countries before their sale can be authorized. The ability of the Corporation to ultimately achieve profitable operations is dependent on a number of factors outside of the Corporation's control.
SELECTED FINANCIAL INFORMATION
(In thousands of dollars, except per share data)
| Three-month periods ended | Years ended | |||||||||||||||||||
| February 29, 2016 | February 28, 2 015 | February 29, 2016 | February 28, 2015 | February 28, 2014 | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
| Revenue from sales | 21 | 178 | 38 | 271 | 501 | |||||||||||||||
| Non-IFRS operating Loss (1) | (1,163 | ) | (2,263 | ) | (6,569 | ) | (8,506 | ) | (5,584 | ) | ||||||||||
| Net loss and comprehensive loss | (1,919 | ) | (2,311 | ) | (6,317 | ) | (1,655 | ) | (11,612 | ) | ||||||||||
| Basic and diluted loss per share | (0.18 | ) | (0.21 | ) | (0.59 | ) | (0.16 | ) | (1.38 | ) | ||||||||||
| Total assets | 28,517 | 37,208 | 28,517 | 37,208 | 45,632 | |||||||||||||||
| Working capital (2) | 12,185 | 18,020 | 10,184 | 18,020 | 24,646 | |||||||||||||||
| Total non-current financial liabilities | 156 | 2,357 | 156 | 2,357 | 11,181 | |||||||||||||||
| Total equity | 27,220 | 33,228 | 27,220 | 33,228 | 33,280 |
RECONCILIATION OF NET LOSS TO NON-IFRS OPERATING LOSS
(In thousands of dollars, except per share data)
| Three-month periods ended | Years ended | |||||||||||||||||||
| February 29, 2016 | February 28, 2015 | February 29, 2016 | February 28, 2015 | February 28, 2014 | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
| Net loss | (1,919 | ) | (2,311 | ) | (6,317 | ) | (1,655 | ) | (11,612 | ) | ||||||||||
| Add (deduct) | ||||||||||||||||||||
| Finance costs | (1 | ) | 2 | 2 | 4 | 1,118 | ||||||||||||||
| Finance Income | (175 | ) | (1,398 | ) | (1,096 | ) | (1,920 | ) | (814 | ) | ||||||||||
| Change in fair value of derivative warrant liabilities | (114 | ) | 703 | (2,201 | ) | (8,824 | ) | 508 | ||||||||||||
| Depreciation and amortization/Impairment of intangible assets | 938 | 584 | 2,734 | 2,335 | 1,774 | |||||||||||||||
| Stock-based compensation | 108 | 157 | 309 | 1,554 | 3,442 | |||||||||||||||
| Non-IFRS operating loss | (1,163 | ) | (2,263 | ) | (6,569 | ) | (8,506 | ) | (5,584 | ) |
The derivative warrant liability declined in fiscals 2016 and 2015 due to the decline in the Corporation's stock price resulting in gains in earnings. Finance income also includes foreign exchange gains mainly on the Corporation's short-term investments in US dollars, which represented $1,022, $1,833, and $782 for the years ended February 29, 2016 and February 28, 2015 and 2014, respectively.
Stock-based compensation expense decreased for the quarter ended February 29, 2016 and the years ended February 29, 2016 and February 28, 2015 as the 2012 grants have fully vested.
The yearly increase in the depreciation and amortization expense from fiscal 2014 to fiscal 2015 is attributable to the prepayment agreement entered into in December 2013, whereby Acasti recognized an intangible asset in the amount of $15,130. See section "Issuance of shares on license prepayment agreement". During the fourth quarter of 2016, the Corporation recorded an asset impairment loss of $339 relating to patents. The Corporation determined that the recoverable amount of these costs was nil as it is no longer probable that sufficient future economic benefits will accumulate to the Corporation due to uncertainties related to project level revenues.
SELECTED QUARTERLY FINANCIAL DATA
(In thousands of dollars, except per share data)
Fiscal year ended February 29, 2016
| February 29, | November 30, | August 31, | May 31, | |||||||||||||
| 2016 | 2015 | 2015 | 2015 | |||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Revenue from sales | 21 | 5 | 7 | 5 | ||||||||||||
| Non-IFRS operating loss | (1,163 | ) | (1,988 | ) | (1,485 | ) | (1,946 | ) | ||||||||
| Net loss | (1,919 | ) | (2,191 | ) | (1,241 | ) | (966 | ) | ||||||||
| Basic and diluted loss per share | (0.18 | ) | (0.20 | ) | (0.12 | ) | (0.09 | ) |
Fiscal year ended February 28, 2015
| February 28, | November 30, | August 31, | May 31, | |||||||||||||
| 2015 | 2014 | 2014 | 2014 | |||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Revenue from sales | 178 | 29 | 8 | 56 | ||||||||||||
| Non-IFRS operating loss | (2,263 | ) | (2,099 | ) | (2,449 | ) | (1,695 | ) | ||||||||
| Net (loss) earnings | (2,311 | ) | 3,012 | (3,712 | ) | 1,356 | ||||||||||
| Basic and diluted loss per share | (0.21 | ) | 0.28 | (0.35 | ) | 0.13 |
In the first, second, third and fourth quarters of fiscal 2016 the change in fair value of the derivative warrant liability was a loss of $1,708, $24, $355 and $114, respectively. The net earnings in the first and third quarters of fiscal 2015 are mainly attributable to the gain resulting from the change in fair value of the derivative warrant liability of $4,634, and $5,211, respectively. In the second and fourth quarters the change in fair value of the derivative warrant liability was a loss of $318 and $703, respectively.
COMMENTS ON THE SIGNIFICANT VARIATIONS OF RESULTS FROM OPERATIONS FOR THE THREE-MONTH PERIODS AND YEARS ENDED FEBRUARY 29, 2016 AND FEBRUARY 28, 2015 AND 2014
The Corporation generated revenues from sales of $21 from the commercialization of Onemia during the three-month period ended February 29, 2016. The Corporation generated revenue from sales of $178 during the corresponding period in 2015.
The Corporation generated revenues from sales of $38 from the commercialization of Onemia during the year ended February 29, 2016, a decrease of $233 from the revenues of $271 generated during the corresponding period in 2015. The Corporation generated revenue from sales of $501 during the corresponding period in 2014. The revenues were generated from sales made directly to customers in the United States. The decline in sales is due to Acasti deciding to find strategic alternatives for Onemia and focus its energy and resources on the development of CaPre . Acasti has entered into a licensing agreement for Onemia with Neptune in which Neptune has to engage in best commercial efforts to market Onemia . Acasti will receive a royalty of 17.5% on net sales of Onemia , therefore, revenues from royalties may vary from period to period. No revenue from royalties has been recognized during the year ended February 29, 2016 and the Corporation does not expect significant revenues in the future.
Gross loss is calculated by deducting the cost of sales from revenue. Cost of sales consists primarily of costs incurred to manufacture products. It also includes related overheads, such as certain costs related to quality control and quality assurance, inventory management, sub-contractors and costs for servicing and commissioning.
The gross loss for the three-month period ended February 29, 2016 amounted to $53 or 3%. The Corporation realized a gross loss of $3 or 2% during the three-month period ended February 28, 2015.
The gross loss for the year ended February 29, 2016 amounted to $44 or 116%. The Corporation realized a gross profit of $36 or 13% during the year ended February 28, 2015 and $209 representing a gross profit margin of 42% during the year ended February 28, 2014. The gross margin for the three-month period ended and year ended February 29, 2016 was lower than the Corporation's target range for its profit margin because of the change in strategy by the Corporation to shift its focus to the development of CaPre .
Breakdown of Major Components of the Statement of Earnings and Comprehensive Loss for the three-month periods and years ended February 29, 2016 and February 28, 2015 and 2014
| Research and development expenses | Three-month periods ended | Years ended | ||||||||||||||||||
| February 29, 2016 | February 28, 2015 | February 29, 2016 | February 28, 2015 | February 28, 2014 | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
| Salaries and benefits | 332 | 86 | 989 | 465 | 457 | |||||||||||||||
| Stock-based compensation | 12 | 39 | 53 | 258 | 601 | |||||||||||||||
| Research contracts | 317 | 1,463 | 2,550 | 5,062 | 3,081 | |||||||||||||||
| Regulatory expenses | 80 | 83 | 472 | 160 | 141 | |||||||||||||||
| Professional fees (1) | 223 | 229 | 567 | 705 | 214 | |||||||||||||||
| Amortization and depreciation (1) | 599 | 584 | 2,395 | 2,335 | 1,774 | |||||||||||||||
| Impairment of intangible assets | 339 | - | 339 | - | - | |||||||||||||||
| Tax credits | (126 | ) | (192 | ) | (169 | ) | (264 | ) | (270 | ) | ||||||||||
| Other | 53 | 51 | 193 | 136 | 61 | |||||||||||||||
| TOTAL | 1,829 | 2,343 | 7,389 | 8,857 | 6,059 |
| General and administrative expenses | Three-month periods ended | Years ended | ||||||||||||||||||
| February 29, 2016 | February 28, 2015 | February 29, 2016 | February 28, 2015 | February 28, 2014 | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
| Salaries and benefits | 143 | 280 | 938 | 1,267 | 990 | |||||||||||||||
| Administrative fees | 50 | - | 50 | - | - | |||||||||||||||
| Stock-based compensation | 96 | 118 | 256 | 1,296 | 2,841 | |||||||||||||||
| Professional fees | 34 | 46 | 650 | 501 | 607 | |||||||||||||||
| Royalties | - | - | - | - | 228 | |||||||||||||||
| Sales and marketing | 5 | 14 | 20 | 29 | 16 | |||||||||||||||
| Investor relations | 33 | 48 | 78 | 63 | 84 | |||||||||||||||
| Rent | (12 | ) | 25 | 67 | 99 | 100 | ||||||||||||||
| Other | (22 | ) | 127 | 119 | 318 | 83 | ||||||||||||||
| TOTAL | 327 | 658 | 2,178 | 3,573 | 4,949 |
Operating loss before interest, taxes, depreciation and amortization (Non-IFRS operating loss)
Three month period ended February 29, 2016 compared to February 28, 2015:
Non-IFRS operating loss decreased by $1,100 for the three-month period ended February 29, 2016 to $1,163 compared to $2,263 for the three-month period ended February 28, 2015, is mainly due to the decrease in research and development expenses before consideration of stock-based compensation, amortization and depreciation and impairment of intangible assets.
Research and development expenses decreased by $502 before consideration of stock-based compensation, amortization and depreciation and impairment of intangible assets. This decrease is mainly attributable to a decrease in research contract expenses related to the Corporation's clinical trials of $1,146, partially offset by an increase in salaries and benefits of $246 and impairment of intangible assets of $339.
General and administrative expenses decreased by $309 before consideration of stock-based compensation. This decrease is mainly attributable to decreases in salaries of $137, rent of $37 and other expenses of $149 partially offset by an increase in administrative fees of $50.
Year ended February 29, 2016 compared to February 28, 2015:
Non-IFRS operating loss decreased by $1,937 for the year ended February 29, 2016 to $6,569 compared to $8,506 for the year ended February 28, 2015, mainly due to the increase in research and development expenses as well as general and administrative expenses before consideration of stock-based compensation and amortization and depreciation, partially offset by the decrease in gross profit of $80.
Research and development expenses decreased by $1,323 before consideration of stock-based compensation and amortization and depreciation. This decrease is mainly attributable to a significant decrease in contract expenses related to the Corporation's clinical trials of $2,512 and other expenses of $181, partially offset by an increase in salaries and benefits of $524, regulatory expenses of $312 and impairment of intangible assets of $339.
General and administrative expenses decreased by $355 before consideration of stock-based compensation. This decrease is mainly attributable to decreases in salaries of $329 and other expenses of $199 partially offset by an increase in professional fees of 149 and administrative fees of $50.
Year ended February 28, 2015 compared to February 28, 2014:
Non-IFRS operating loss increased by $2,922 for the year ended February 28, 2015 to $8,506 compared to $5,584 for the year ended February 28, 2014, mainly due to the increase in research and development expenses, before consideration of stock-based compensation and decrease in gross profit. The increase in research and development expenses before stock based compensation and amortization and depreciation of $2,580 is mainly attributable to increases in contract expenses of $1,981 and professional fees related to the Corporation's clinical trials of $491.
The Corporation realized a net loss for the three-month period ended February 29, 2016 of $1,919 or $0.18 per share compared to a net loss of $2,311 or $0.21 per share for the three-month period ended February 28, 2015. These results are mainly attributable to the factors described above in the Gross Profit (loss) and Non-IFRS operating loss sections as well as by the decrease in value of the derivative warrant liabilities of $818 and decrease in stock-based compensation expenses of $49.
The Corporation realized a net loss for the year ended February 29, 2016 of $6,317 or $0.59 per share compared to a net loss of $1,655 or $0.16 per share for the year ended February 28, 2015. These results are mainly attributable to the factors described above in the Gross Loss and Non-IFRS operating loss sections as well as by the decrease in value of the derivative warrant liabilities of $2,201 compared to a decrease of $8,824 in prior period, a decrease in the foreign exchange gain over the prior period by $810 and a decrease in stock-based compensation expenses of $1,245, offset by a slight increase in amortization and depreciation of $58. The foreign exchange gain is due mainly to the strengthening US dollar impact on the Corporation's US dollar short-term investments. Stock-based compensation decreased as grants provided in 2012 have fully vested.
The Corporation realized a net loss for the year ended February 28, 2015 of $1,655 or $0.16 per share compared to a net loss of $11,612 or $1.38 per share for the year ended February 28, 2014. These results are mainly attributable to the factors described above in the Gross Profit and Non-IFRS operating loss sections as well as by the decrease in value of the derivative warrant liabilities of $8,824 compared to an increase of $507 in prior period, an increase in the foreign exchange gain over the prior period by $1,051 and a decrease in stock-based compensation expenses of $1,888, offset by increases in amortization and depreciation of $561, following the increase in the Corporation's license asset as a result of the prepayment agreement with Neptune. The foreign exchange gain is due mainly to the strengthening US dollar impact on the Corporation's US dollar short-term investments. Stock-based compensation decreased as grants provided in 2012 are fully vested.
LIQUIDITY AND CAPITAL RESOURCES
Share Capital Structure
(In thousands of dollars, except per share data)
The 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 as at the years ended:
| February 29, 2016 | February 28, 2015 | February 28, 2014 | ||||||||||
| Class A shares, voting, participating and without par value | 10,712,038 | 10,644,440 | 10,586,253 | |||||||||
| Stock options granted and outstanding | 454,151 | 429,625 | 491,100 | |||||||||
| Restricted Shares Units granted and outstanding | - | 18,398 | 77,494 | |||||||||
| Series 6 & 7 warrants expired on February 10, 2015 | - | - | 75,000 | |||||||||
| Series 8 warrants exercisable at $1.50 USD, until | ||||||||||||
| December 3, 2018 (1) | 1,840,000 | 1,840,000 | 1,840,000 | |||||||||
| Series 9 warrants exercisable at $16,00, until | ||||||||||||
| December 3, 2018 | 161,654 | 161,654 | 161,654 | |||||||||
| Total fully diluted shares | 13,167,843 | 13,094,117 | 13,231,501 |
(1) Total of 18,400,000 units, in order to obtain one share of Acasti, 10 units must be exercised.
Issuance of shares on license prepayment agreement
On July 12, 2013, the Corporation issued 675,000 Class A shares, at a price of $23.00 per share to Neptune to pay in advance all of the future royalties' payable under the intellectual property license it had with Neptune.
The value of the prepayment, determined with the assistance of outside valuations specialists, using the pre-established formula set forth in the license agreement (adjusted to reflect the royalties of $395 accrued from December 4, 2012, the date at which the Corporation entered into the prepayment agreement to July 12, 2013, the date of issuance of the shares) totalling $15,130, was recognized as an intangible asset. The shares issued as a result of this transaction corresponded to an increase in share capital of $15,525, net of $29 of share issue costs. The Corporation no longer has a royalty payment commitment under the License Agreement.
CASH FLOWS AND FINANCIAL CONDITION BETWEEN THE THREE-MONTH PERIODS AND YEARS ENDED FEBRUARY 29, 2016, AND FEBRUARY 28, 2015 AND 2014
Operating Activities
During the three-month periods ended February 29, 2016 and February 28, 2015, the Corporation's activities generated decreases in liquidities of $1,691 and $2,622, respectively. The decrease in the cash flows from operating activities for the three-month period ended February 29, 2016 is mainly attributable to the changes in non-cash working capital items.