Acasti Announces First Quarter Results
15 Julio 2013 - 7:00AM
Acasti Pharma ("Acasti" or the "Corporation") (Nasdaq:ACST)
(TSX-V:APO), a Neptune Technologies & Bioressources Inc.'s
("Neptune") subsidiary, announces its financial results for the
first quarter ended May 31, 2013.
First Quarter Financial Results
- Revenues were $6,000 for the quarter ended May 31, 2013, versus
$14,000 for the quarter ended May 31, 2012. Sales in both years
were generated from the commercialization of Onemia™, the
Corporation's medical food product.
- Research and development expenses were $779,000 for the current
quarter, up from $560,000 in the corresponding prior-year
quarter.
- Adjusted EBITDA was negative $(1,260,000) for the quarter ended
May 31, 2013, versus negative $(916,000) in the corresponding
prior-year quarter.
- A net loss of $(1,965,000) or $(0.03) per share was recorded
for the current quarter, versus a net loss of $(1,576,000) or
$(0.02) per share in the same quarter last year.
Acasti currently relies on a limited number of distributors and
clients for Onemia™ and consequently, quarter to quarter revenues
may vary significantly. Acasti continues to work on broadening
its distribution network and client base for
Onemia™.
Update on Status of Phase II Clinical
Trials
Acasti's Phase II clinical trials, designed to evaluate the
effect of different daily doses of CaPre® on patients with high to
very high triglyceride levels, continued to progress during the
quarter and remain on schedule. The final report for the
open-label, dose ranging study (COLT) is expected for this summer,
while completion of the double blind, placebo controlled study
(TRIFECTA) is projected for the first half of calendar 2014.
"We remain focused on the completion of our phase II clinical
trials," said Dr. Harlan Waksal, Executive Vice-President, Business
& Scientific Affairs. "Concurrently with these trials, we
are moving forward with our plans to submit an Investigational New
Drug filing to initiate pivotal phase III clinical trials of CaPre®
in the USA. At the same time, we continue to seek out and
secure third party manufacturers, including a Good Manufacturing
Practices (GMP) facility for production of CaPre®."
Acasti Becomes Royalty Free
On December 4, 2012, the Corporation announced that it had
entered into a prepayment agreement with its parent company,
Neptune, pursuant to which Acasti exercised its option under the
exclusive technology license agreement (the "License Agreement")
between the two parties to pay in advance all future royalties
payable under the License Agreement.
At Acasti's Annual and Special Meeting, held on June 27, 2013,
the Corporation's disinterested shareholders (excluding Neptune and
non-arm's length parties to Neptune) voted in favour of becoming
royalty free and paying in advance all future royalties owed under
the License Agreement through the issuance of shares to
Neptune. As required, Acasti also received approval from the
TSX Venture Exchange.
The value of the royalty prepayment, which was confirmed by an
independent valuation expert using the pre-established prepayment
formula set forth in the License Agreement, is approximately $15.5
million and was paid through the issuance of 6,750,000 Acasti Class
"A" common shares to Neptune. The prepayment increases
Neptune's equity participation in Acasti from approximately 57% to
approximately 60%.
Being royalty free allows Acasti to preserve cash of at least
$700,000 annually, which was the current minimum royalty due under
the License Agreement. It should also bring more flexibility
and strength in negotiating deals with potential business
partners.
About Acasti Pharma Inc.
Acasti is developing a product portfolio of proprietary novel
long-chain omega-3 phospholipids. Phospholipids are the major
component of cell membranes and are essential for all vital cell
processes. They are one of the principal constituents of High
Density Lipoprotein (good cholesterol) and, as such, play an
important role in modulating cholesterol efflux. Acasti's
proprietary novel phospholipids carry and functionalize the
polyunsaturated omega-3 fatty acids EPA and DHA, which have been
shown to have substantial health benefits and which are stabilized
by potent antioxidants. Acasti is focusing initially on treatments
for chronic cardiovascular and cardiometabolic conditions within
the medical food and prescription drug markets.
"Neither NASDAQ nor the TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release." Statements in this press release that
are not statements of historical or current fact constitute
"forward-looking statements" within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995 and Canadian securities
laws. Such forward-looking statements involve known and unknown
risks, uncertainties, and other unknown factors that could cause
the actual results of the Corporation to be materially different
from historical results or from any future results expressed or
implied by such forward-looking statements. In addition to
statements which explicitly describe such risks and uncertainties,
readers are urged to consider statements labeled with the
terms "believes," "belief," "expects," "intends," "anticipates,"
"will," or "plans" to be uncertain and forward-looking. The
forward-looking statements contained herein are also subject
generally to other risks and uncertainties that are described from
time to time in the Corporation's reports filed with the Securities
and Exchange Commission and the Canadian securities
commissions.
CONTACT: Acasti Contact:
Xavier Harland
Chief Financial Officer
+1.450.687.2262
x.harland@acastipharma.com
www.acastipharma.com
Howard Group Contact:
Dave Burwell
(888) 221-0915
dave@howardgroupinc.com
www.howardgroupinc.com
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