Full Press Release Details
ANNUAL INFORMATION FORM
Fiscal Year Ended February 28, 2014
| Basis of Presentation | 1 | |||
| Cautionary Note Regarding Forward-Looking Information | 1 | |||
| Corporate Structure | 3 | |||
| Company Overview | 3 | |||
| Intercorporate Relationships | 3 | |||
| Acasti s Business | 3 | |||
| Business Strategy | 4 | |||
| Treatments for Cardiometabolic Disorders Acasti s Market | 5 | |||
| Acasti s Products | 7 | |||
| ONEMIA | 8 | |||
| Clinical and Nonclinical Research | 9 | |||
| Sales and Marketing | 12 | |||
| Competition | 13 | |||
| Intellectual Property | 14 | |||
| Raw Materials, Manufacturing and Facility | 16 | |||
| Employees, Specialized Skills and Knowledge | 17 | |||
| Litigation | 17 | |||
| Government Regulation | 19 | |||
| History and Development of the Corporation | 24 | |||
| Three-Year History | 24 | |||
| Recent Developments | 27 | |||
| Risk Factors | 27 | |||
| Dividends | 46 | |||
| Description of Capital Structure | 46 | |||
| Common Shares | 47 | |||
| Preferred Shares | 47 | |||
| Market for Securities | 51 | |||
| Trading Prices and Volumes for Acasti | 51 | |||
| Escrowed Securities and Securities subject to Restriction on Transfer | 51 | |||
| Directors and Officers | 52 | |||
| Name, Occupation and Security Holding of Directors and Executive Officers | 52 | |||
| Cease Trade Orders, Bankruptcies, Penalties or Sanctions | 54 | |||
| Legal Proceedings and Regulatory Actions | 55 | |||
| Interest of Management and Others in Material Transactions | 55 | |||
| Transfer Agents and Registrars | 55 | |||
| Material Contracts | 55 | |||
| Interest of Experts | 56 | |||
| Report on Audit Committee | 56 | |||
| Audit Committee s Charter | 56 | |||
| Composition of the Audit Committee | 56 | |||
| External Auditor Fees | 57 | |||
| Additional Information | 57 | |||
| Schedule A | A-1 |
BASIS OF PRESENTATION
As used in this annual information form ( AIF ), unless the context otherwise requires, references to
Acasti , Acasti Pharma , Corporation , it , its or similar terms refer to Acasti Pharma Inc., references to Neptune refer to Acasti s parent company, Neptune
Technologies & Bioressources Inc., and references to NeuroBioPharm refer to Acasti s sister company, NeuroBioPharm Inc.
Market data and certain industry data and forecasts included in this AIF were obtained from internal company surveys, market research,
publicly available information, reports of governmental agencies and industry publications and surveys. Acasti has relied upon industry publications as its primary sources for third-party industry data and forecasts. Industry surveys, publications
and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable, but that the accuracy and completeness of such information is not guaranteed. Acasti has not independently verified any of
the data from third-party sources, nor has Acasti ascertained the underlying economic assumptions relied upon therein. Similarly, internal surveys, industry forecasts and market research, which Acasti believes to be reliable based upon
management s knowledge of the industry, have not been independently verified. Forecasts are particularly likely to be inaccurate, especially over long periods of time. In addition, Acasti does not know what assumptions regarding general
economic growth were used in preparing the forecasts cited in this AIF. While Acasti is not aware of any misstatements regarding Acasti s industry data presented herein, Acasti s estimates involve risks and uncertainties and are subject to
change based on various factors, including those discussed under Risk Factors in this AIF. While Acasti believes its internal business research is reliable and market definitions are appropriate, neither such research nor definitions
have been verified by any independent source. This AIF may only be used for the purpose for which it has been published.
noted, in this AIF, all information is presented as of February 28, 2014. All references in this AIF to dollars , CDN$ and $ refer to Canadian dollars, and references to US$ refer to United States
dollars, unless otherwise expressly stated.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This AIF 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 AIF 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 AIF includes, but is not limited to, information or statements about:
Although the forward-looking information in this AIF 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.
forward-looking information in this AIF is subject to a number of known and unknown risks, uncertainties and other factors, including those described in this AIF 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 in this AIF 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 AIF.
was incorporated on February 1, 2002 under Part 1A of the Companies Act (Qu bec) under the name 9113-0310 Qu bec Inc . On August 7, 2008, pursuant to a Certificate of Amendment, the Corporation
changed its name to Acasti Pharma Inc. , its share capital, the provisions regarding the restriction on securities transfers and the borrowing powers of the Corporation. On November 7, 2008, pursuant to a Certificate of
Amendment, the Corporation has further revised its provisions regarding its borrowing powers. The Corporation became a reporting issuer in the Province of Qu bec on November 17, 2008. On February 14, 2011, the Business
Corporations Act (Qu bec) came into effect and replaced the Companies Act (Qu bec). Acasti is now governed by the Business Corporations Act (Qu bec).
Acasti s head office and registered office is located at 545 Promenade du Centropolis, Suite 100, Laval, Qu bec
H7T 0A3. The Corporation s website address is http://www.acastipharma.com. The Corporation does not incorporate the information on or accessible through its website into this AIF, and you should not consider any information on, or that can
be accessed through, its website as part of this AIF.
Intercorporate Relationships
The Corporation has no subsidiaries. As of the date of this AIF, Neptune owns 51,942,183 Class A shares of Acasti (the Common
Shares ), representing approximately 49% of the Common Shares issued and outstanding. The Common Shares are voting, participating and have no par value. Neptune also owns a warrant entitling it to acquire 592,500 Common Shares.
The Common Shares are listed on the TSX Venture Exchange ( TSXV ) under the ticker symbol APO and on The
NASDAQ Stock Market ( NASDAQ ) under the ticker symbol ACST .
emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, in particular
abnormalities in blood lipids, also known as dyslipidemia. Because krill feeds on phytoplankton (diatoms and dinoflagellates), it is a major source of phospholipids and polyunsaturated fatty acids ( PUFAs ), 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.
CaPre , currently Acasti s only prescription drug candidate, is a highly
purified omega-3 phospholipid concentrate derived from krill oil and is being developed to help prevent and treat hypertriglyceridemia, which is a condition characterized by abnormally high levels of triglycerides in the bloodstream. Phospholipids
represent approximately two-thirds of the composition of CaPre . The majority of EPA and DHA contained in CaPre is bound to
phospholipids, allowing these PUFAs to more readily reach the small intestine where they undergo faster absorption and transformation into complex fat molecules that are required for transport in the bloodstream. Acasti
believes that EPA and DHA are more efficiently transported by phospholipids than EPA and DHA contained in fish oil which are transported by triglycerides and must undergo additional digestion
before they are ready for transport in the bloodstream. See Acasti s Products - Overview .
CaPre is designed to be used as a therapy in conjunction with positive lifestyle changes and administered either alone or with other treatment regiments such as statins (a class of drug used to reduce
cholesterol levels) and potentially for use by statin-intolerant or statin-resistant patients. CaPre is being developed for the treatment of patients with high triglycerides with levels
ranging from 200 to 499 mg/dL ( mild to moderate hypertriglyceridemia ) and very high triglycerides with levels over 500mg/dL ( severe hypertriglyceridemia ). In addition to targeting the reduction of triglyceride
levels, clinical data collected and reviewed by the Corporation to date has indicated that CaPre may also normalize blood lipids by increasing high density lipoprotein
( HDL-C ) (good cholesterol). and reducing non-high density lipoprotein ( non-HDL-C ), which includes all cholesterol contained in the bloodstream except HDL-C. In addition, clinical data collected by Acasti to date
indicates that CaPre has no significant deleterious effect on low density lipoprotein ( LDL-C ) (bad cholesterol) levels. Future clinical trials of Acasti, which may include trials
specifically designed to evaluate the effect of CaPre on LDL-C levels, may further assist Acasti in evaluating the effect of CaPre on
LDL-C levels and validate reductions of LDL-C observed by Acasti in its nonclinical trials. See Acasti s Business - Clinical and Nonclinical Research - Clinical . Due to a recent decision of the U.S. Food and Drug
Administration s (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 may put a primary and first focus on the severe hypertriglyceridemia population.
During the fiscal year ended
February 29, 2012, Acasti initiated the TRIFECTA and COLT trials, two Phase II clinical trials in Canada designed to evaluate the safety and efficacy of CaPre for the treatment of
patients with levels of triglycerides ranging from 2.28 to 10.0 mmol/L (200-877 mg/dL). On August 13, 2013, Acasti announced the completion and results of its open-label COLT trial. Acasti s double-blind TRIFECTA trial is ongoing and
Acasti expects results to be available during the first half of 2014. See Acasti s Business - Clinical and Nonclinical Research - Clinical .
Further to the completion of the Phase II COLT trial, and in parallel with the ongoing Phase II TRIFECTA trial, being conducted in Canada, the
Corporation has filed an investigational new drug ( IND ) application with the FDA, to conduct a pharmacokinetic ( PK ) trial, which Acasti expects to conduct prior to a Phase III clinical trial that Acasti intends
to conduct in the United States, with potentially a few Canadian clinical trial sites, under the guidelines and rules of the FDA. Concurrently, Acasti is corresponding with the FDA and has responded to the FDA s recommendations regarding its
upcoming IND filing for its phase III clinical trial of CaPre in the United States. The FDA has invited Acasti to formally request an end of phase II/pre phase III meeting to allow them to
provide feedback on the submission and to address specific questions for which Acasti is seeking approval and final response from the FDA. Acasti intends to seek such meeting as soon as TRIFECTA trial results are available. See Acasti s
Business - Clinical and Nonclinical Research - Clinical - Next Steps .
ONEMIA , a medical food and currently Acasti s only commercialized product, is a
purified omega-3 phospholipid concentrate derived from krill oil with lower levels of phospholipids, EPA and DHA content than CaPre . Based on nonclinical studies conducted by Acasti,
supported by clinical testing conducted on Neptune Krill Oil (NKO ), Acasti believes ONEMIA to be safe and effective for the dietary
management of omega-3 phospholipid deficiency related to abnormal lipid profiles and cardiometabolic disorders. See Acasti s Business - Acasti s Products - ONEMIA .
Acasti s strategy to commercialize therapies for dyslipidemia and other cardiometabolic disorders include: (i) completing Acasti s Phase II TRIFECTA clinical trial in Canada, initiating and completing PK and a Phase III clinical trial
and filing a New Drug Application ( NDA ) to obtain regulatory approval for CaPre in the United States (initially for the treatment of severe hypertriglyceridemia and
thereafter for the treatment of mild to moderate hypertriglyceridemia); (ii) strengthening Acasti s patent portfolio and other means of protecting intellectual property exclusivity; (iii) pursuing distribution partnerships to
commercialize CaPre in the United States and elsewhere; and (iv) continuing to generate awareness of ONEMIA throughout the
medical community in an effort to build a market foundation for CaPre . Acasti may also pursue strategic opportunities including
licensing or similar transactions, joint ventures, partnerships, strategic alliances or alternative financing transactions to provide sources of capital for Acasti. However, no assurance can be
given as to when or whether Acasti will pursue any such strategic opportunities.
Treatments for Cardiometabolic Disorders Acasti s
Lipid Disorders and Cardiovascular Disease
Heart attacks, strokes and other cardiovascular events represent the leading cause of death and disability among men and women in the United
States. According to the 2011 At-A-Glance Report from the U.S. Center for Disease Control, more than 1 out of every 3 adults in the United States (approximately 83 million) currently lives with one or more types of cardiovascular disease; an
estimated 935,000 heart attacks and 795,000 strokes occur in the United States each year; and an estimated 71 million adults in the United States have high cholesterol (i.e., high levels of LDL-C). Having abnormally high levels of lipids or
lipoproteins, such as cholesterol and triglycerides, which are fats carried in the bloodstream, is an important risk factor for cardiovascular disease.
According to the American Heart Association, the prevalence of hypertriglyceridemia is increasing in the United States and globally,
correlating to the increasing incidence of obesity and diabetes. Market participants, including the American Heart Association, have estimated that one-third of the population in the United States has elevated levels of triglycerides, including over
40 million people diagnosed with mild to moderate hypertriglyceridemia and over 4 million people diagnosed with severe hypertriglyceridemia. According to The American Heart Association Scientific Statement on Triglycerides and
Cardiovascular Disease (2011), triglyceride levels provide important information as a marker associated with the risk for heart disease and stroke, especially when an individual also has low HDL-C and elevated levels of LDL-C. Lowering triglyceride
levels is one of the primary goals to reduce a patient s risk of atherosclerotic cardiovascular disease. Hypertriglyceridemia is due to both genetic and environmental factors, including obesity, sedentary lifestyle and high-calorie diets.
Hypertriglyceridemia is also associated with comorbid conditions such as chronic renal failure, pancreatitis, nephrotic syndrome and diabetes.
Patients with type 2 diabetes are more susceptible to cardiovascular disease. Cardiovascular disease may be preventable in some patients with
appropriate treatment of lipid abnormalities. Diabetic dyslipidemia most commonly manifests as elevated triglycerides and low levels of HDL-C, with a predominance of small, dense LDL-C particles amid relatively normal LDL-C levels. Non-HDL-C
reduction is a key secondary goal of therapy under the National Cholesterol Education Program Adult Treatment Panel III national lipid treatment guidelines and, according to the American Diabetes Association and the American College of Cardiology,
has been emphasized as a major goal of therapy in the consensus guidelines for lipoprotein management in patients with cardiometabolic risk. Acasti believes, based in part on a study published by Blaha MJ et al. in The Journal of Clinical Lipidology
in 2008, that non-HDL-C levels may be a better indicator than LDL-C for the prediction of cardiovascular events and that non-HDL-C reduction has many other compelling advantages over LDL-C and other traditional lipid parameters. Studies have
established the clinical utility of non-HDL-C as a comprehensive measure of atherogenic lipoproteins. In diabetic patients, non-HDL-C levels may be a stronger predictor of cardiovascular disease than LDL-C levels or triglycerides because it