Acasti Pharma Inc., an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for heart health, announces its consolidated financial results for the fourth quarter and fiscal year ended Feb. 28, 2014.
Financial results: fourth quarter ended Feb. 28, 2014
- Revenues were $201,000 for the quarter ended Feb. 28, 2014, versus $49,000 for the quarter ended Feb. 28, 2013. Sales in both years were generated from the commercialization of Onemia(R), the Corporation's medical food product
- Research and development (R&D) expenses were $714,000 for the quarter, down from $918,000 in the prior year
- Adjusted EBITDA was negative $(977,000) for the quarter, versus negative $(1,373,000) in the prior year
- Net loss was $(2,553,000) for the quarter, versus a net loss of $(1,952,000) in the prior year.
The year-over-year improvement in adjusted EBITDA is largely due to lower R&D expenses. As well, general and administrative expenses were down due to lower professional fees and royalties, with Acasti now being royalty free from Neptune.
The increase in the year-over-year net loss is largely due to higher depreciation and amortization expenses, following an increase in the Corporation's licensed asset, resulting from the royalty prepayment agreement with Neptune, and higher stock based compensation expenses.
Financial results: fiscal year ended Feb. 28, 2014
- Revenues were $501,000 for the fiscal year ended Feb. 28, 2014, versus $724,000 for the year ended Feb. 28, 2013. Sales in both years were generated from the commercialization of Onemia(R), the Corporation's medical food product
- Research and development expenses were $4,297,000 for the year, up from $3,009,000 in the prior year
- Adjusted EBITDA was negative $(5,584,000) for the year, versus negative $(4,397,000) in the prior year
- A net loss of $(11,612,000) or $(0.14) per share was recorded for the year, versus a net loss of $(6,892,000) or $(0.09) per share in the prior year.
Research and development expenses were up over the prior year due to an increase in contract expenses related to Acasti's clinical trials.
The year-over-year decline in adjusted EBITDA was driven by the higher R&D expenses described above.
The higher net loss over the prior year was largely due to expense increases related to depreciation and amortization, stock based compensation and R&D.
"Over the past year, we continued to strengthen our business, and focus our efforts on moving closer to securing regulatory approval for our investigational new drug candidate, CaPre(R)," said Pierre Lemieux, Acasti's chief operating officer. "We actively advanced our research and clinical development program, secured a manufacturing agreement for CaPre(R) clinical material, successfully completed a major financing and defended and strengthened our intellectual property. These successes are a testimony to our commitment to lay the groundwork for future growth and create sustained shareholder value by further positioning Acasti as a leader in pharmaceutical grade omega-3 phospholipids. There remain a number of important milestones ahead. However, with the encouraging results seen to date, a strong team, a solid balance sheet and a firm drive to succeed, we are well positioned to seize the opportunities before us."
Phase II TRIFECTA Trial
The number of targeted patients evaluable as per protocol has been reached. Acasti is currently evaluating the efficacy and safety of CaPre(R) for the treatment of patients with mild to severe hypertriglyceridemia, which is the primary objective of the study. The secondary objective of evaluating if statistically significant efficacy was reached in patient populations with mild to moderate (triglyceride levels ranging from 200 to 499 mg/dL) and severe hypertriglyceridemia (triglyceride levels over 500 mg/dL) will also be assessed separately. Based on patient information currently available, the Corporation does not believe the sample size is large enough to conclude the efficacy of CaPre in treating severe hypertriglyceridemia as part of the TRIFECTA trial. Based on literature, Acasti does not expect the FDA to request efficacy data on patients with severe hypertriglyceridemia before granting permission to conduct a Phase III trial. Acasti is targeting trial completion by the end of the second quarter of calendar 2014 and results will be available at a future date yet to be determined.
Pharmacokinetic (PK) Trial
As previously announced the US Food and Drug Administration (FDA) gave Acasti clearance to initiate a PK trial in the US. The trial is underway and is expected to be completed by the end of the second quarter of calendar 2014, with results being announced in the following quarter.
Phase 3 Trial
Concurrently with the PK trial, the Corporation is corresponding with the FDA and has responded to their recommendations regarding Acasti's upcoming Investigational New Drug (IND) filing for a pivotal Phase III clinical trial of CaPre(R) in the US. 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 a buy-in and final response from the FDA. Acasti intends to do this as soon as TRIFECTA trial results are available.
With the FDA's recent decision to not grant authorization to commercialize Acasti competitors' drugs 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.