ALISO VIEJO, Calif.,
Jan. 13, 2014 /PRNewswire/ --
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced
preliminary financial information (unaudited) for the quarter-ended
December 31, 2013, in anticipation of
the company's attendance at the J.P. Morgan 32nd Annual
Healthcare Conference.
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Based on preliminary financial information (unaudited) for the
quarter-ended December 31, 2013,
Avanir estimates:
- Total gross revenues of approximately $34.6 million (Non-GAAP)
- Gross product revenue for NUEDEXTA® of approximately
$31.3 million (Non-GAAP),
representing an increase of approximately 13% versus the quarter
ended September 30, 2013
- NUEDEXTA gross-to-net discount in the range of approximately
24-26%
- NUEDEXTA net product revenue growth of approximately 15-18%
sequentially over the previous quarter
- Cash used in operations of approximately $9.5 million
- Cash, cash equivalents and investments in securities totaling
approximately $46.5 million,
including cash and cash equivalents of approximately $43.9 million and restricted investments in
securities of approximately $2.6
million
About NUEDEXTA
NUEDEXTA is an innovative combination
of two well-characterized components; dextromethorphan hydrobromide
(20 mg), the ingredient active in the central nervous system, and
quinidine sulfate (10 mg), a metabolic inhibitor enabling
therapeutic dextromethorphan concentrations. NUEDEXTA acts on
sigma-1 and NMDA receptors in the brain, although the mechanism by
which NUEDEXTA exerts therapeutic effects in patients with PBA is
unknown.
NUEDEXTA Important Safety Information
NUEDEXTA is
indicated for the treatment of pseudobulbar affect (PBA). PBA
occurs secondary to a variety of otherwise unrelated neurological
conditions, and is characterized by involuntary, sudden, and
frequent episodes of laughing and/or crying. PBA episodes typically
occur out of proportion or incongruent to the underlying emotional
state.
Studies to support the effectiveness of NUEDEXTA were performed
in patients with amyotrophic lateral sclerosis (ALS) and multiple
sclerosis (MS). NUEDEXTA has not been shown to be safe and
effective in other types of emotional lability that can commonly
occur, for example, in Alzheimer's disease and other dementias.
NUEDEXTA and certain other medicines can interact, causing
serious side effects. If you take certain drugs or have certain
heart problems, NUEDEXTA may not be right for you.
NUEDEXTA causes dose-dependent QTc prolongation. When initiating
NUEDEXTA in patients at risk for QT prolongation and torsades de
pointes, electrocardiographic (ECG) evaluation should be conducted
at baseline and 3-4 hours after the first dose.
The most common adverse reactions are diarrhea, dizziness,
cough, vomiting, asthenia, peripheral edema, urinary tract
infection, influenza, increased gamma-glutamyltransferase, and
flatulence. NUEDEXTA may cause dizziness.
These are not all the risks from use of NUEDEXTA. Please refer
to full Prescribing Information at www.NUEDEXTA.com.
About Avanir Pharmaceuticals, Inc.
Avanir
Pharmaceuticals, Inc. is a biopharmaceutical company focused on
bringing innovative medicines to patients with central nervous
system disorders of high unmet medical need. As part of our
commitment, we have extensively invested in our pipeline and are
dedicated to advancing medicines that can substantially improve the
lives of patients and their loved ones. For more information about
Avanir, please visit www.avanir.com.
AVANIR® and NUEDEXTA® are trademarks or
registered trademarks of Avanir Pharmaceuticals, Inc. in
the United States and other
countries. All other trademarks are the property of their
respective owners.
©2014 Avanir Pharmaceuticals, Inc. All Rights Reserved.
Forward Looking Statements
Except for the
historical information contained herein, the matters set forth in
this press release, including statements regarding Avanir's plans,
potential opportunities, financial or other expectations,
projections, goals objectives, milestones, strategies, market
growth, timelines, legal matters, product pipeline, clinical
studies, product development and the potential benefits of its
commercialized products and products under development are
forward-looking statements within the meaning of the "safe harbor"
provisions of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially,
including the risks and uncertainties associated with Avanir's
operating performance and financial position, the market demand for
and acceptance of Avanir's products domestically and
internationally, research, development and commercialization of new
products domestically and internationally, obtaining additional
indications, obtaining and maintaining regulatory approvals
domestically and internationally, and other risks detailed from
time to time in the Company's most recent Annual Report on Form
10-K and other documents subsequently filed with or furnished to
the Securities and Exchange Commission. These forward-looking
statements are based on current information that may change and you
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press release.
All forward-looking statements are qualified in their entirety by
this cautionary statement, and the Company undertakes no obligation
to revise or update any forward-looking statement to reflect events
or circumstances after the issuance of this press release.
Note Regarding Non-GAAP Financial Information
This
press release contains unaudited financial information under both
U.S. generally accepted accounting principles (GAAP) basis and
Non-GAAP basis. This Non-GAAP financial measure of gross
revenue excludes contra revenue items to reflect an additional way
of viewing aspects of our operations that, when viewed with the
GAAP results and the reconciliations to the corresponding GAAP
financial measure, provide a more complete understanding of our
financial information and the factors and trends affecting our
business. However, these Non-GAAP measures should be
considered as a supplement to, and not as a substitute for, or
superior to, the corresponding measure calculated in accordance
with GAAP. We use our Non-GAAP financial measures internally
to better understand and evaluate our business, prepare annual
budgets, and in measuring performance.
Non-GAAP financial measures contained in this press release
reflects adjustments based on the following items:
Total Gross Revenues. Total gross revenues exclude
allowances for customer credits, including estimated discounts,
rebates, chargebacks and co-pay assistance (collectively, "Customer
Credits"), the costs of which would be included in our net revenue
figures. We believe that the exclusion of the Customer
Credits provides management and investors with an additional basis
on which to evaluate the growth of the NUEDEXTA sales revenues and
the potential addressable market for NUEDEXTA, particularly given
that there are no other drugs approved to treat PBA. We are
unable to provide a reconciliation of total net revenues to total
gross revenues because, at this time, we are in the process of
completing our financial statements for the three months ended
December 31, 2013 and are finalizing
the accounting of the Customer Credits that account for the
difference between the gross and net revenue figures.
Avanir Investor & Media Contact
Ian Clements, PhD
ir@avanir.com
+1 (949) 389-6700
SOURCE Avanir Pharmaceuticals, Inc.