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Avanir Pharmaceuticals Reports Fiscal 2013 First Quarter Financial And Business Results



    Avanir Pharmaceuticals Reports Fiscal 2013 First Quarter Financial And
                               Business Results

PR Newswire

ALISO VIEJO, Calif., Feb. 7, 2013

ALISO VIEJO, Calif., Feb. 7, 2013 /PRNewswire/ -- Avanir Pharmaceuticals, Inc.
(NASDAQ: AVNR) today reported financial results for the three months ended
December 31, 2012.

(Logo: http://photos.prnewswire.com/prnh/20130207/LA55901LOGO)

Quarterly Financial Highlights

  o Total company net revenues increased to $16.5 million, representing growth
    of 22% versus the previous quarter
  o Gross and net NUEDEXTA® sales increased to $18.4 million and $14.9
    million, respectively, representing growth of 19% and 20% versus the
    previous quarter
  o Cash, cash equivalents, and restricted investments of $59.3 million as of
    December 31, 2012.

"Avanir delivered another strong quarter of growth with record NUEDEXTA sales
and prescriptions," said Keith A. Katkin, president and CEO of Avanir.  "In
addition, the clinical team has successfully executed our plan to move our
next generation asset, AVP-786, through the first stage of the phase I
clinical study, with encouraging results. With demonstrated success in the
AVP-786 study, we now have two promising assets in clinical development, each
of which has broad potential in a number of CNS indications."

Fiscal 2013 First Quarter Results

  o Total net revenues for the quarter ended December 31, 2012 were $16.5
    million, compared with $7.2 million for the comparable quarter in fiscal
    2012, representing 130% year-over-year growth. Total net revenues consist
    of NUEDEXTA revenue and royalty revenue from Abreva®.
  o Total operating expenses, excluding cost of sales and share-based
    compensation were $25.3 million in the first quarter of fiscal 2013,
    compared with $21.7 million in the comparable period in fiscal 2012.
  o Cash used in operations was $12.7 million in the first quarter of fiscal
    2013.
  o Net loss for the fiscal 2013 first quarter was $12.1 million, or $0.09 per
    share, compared with a net loss of $15.9 million, or $0.12 per share, for
    the same period in fiscal 2012.

NUEDEXTA Revenue

For the quarter ended December 31, 2012, the company reported NUEDEXTA gross
and net revenue of $18.4 million and $14.9 million respectively. First quarter
fiscal 2013 NUEDEXTA net revenue increased 20% over the previous quarter.

Cash, Cash Equivalents & Marketable Securities

As of December 31, 2013 Avanir had cash, cash equivalents and investments in
securities totaling $59.3 million, including cash and cash equivalents of
$56.9 million and restricted investments in securities of $2.4 million.

Business Highlights

  o The company reported its seventh consecutive quarter of record NUEDEXTA
    revenues and prescriptions
  o Over 13,000 cumulative patient years of exposure of NUEDEXTA in PBA across
    multiple neurologic conditions
  o The company successfully completed the first stage of a two-stage
    pharmacokinetic study with AVP-786
  o Continued clinical progress in three potential follow-on indications for
    AVP-923 in Alzheimer's disease, neuropathic pain, and Parkinson's disease
  o The Michael J. Fox Foundation awarded the company a grant to study AVP-923
    for the treatment of levodopa-induced-dyskinesia (LID) in Parkinson's
    disease (PD)

Note to Investors: As previously announced, Avanir will hold a conference call
to discuss fiscal 2013 first quarter financial results today, February 7,
2013, beginning at 1:30 p.m. Pacific Time. You can listen to this call by
dialing 1-866-783-2141 for domestic callers or +1-857-350-1600 for
international callers, and entering passcode 51423033. Those interested in
listening to the conference call live via the internet may do so by visiting
http://ir.avanir.com.

About AVP-786

AVP-786 is a novel compound developed through incorporation of deuterium into
specific molecular positions of dextromethorphan.  The compound maintains
similar pharmacology to that of dextromethorphan, but is less susceptible to
metabolism by the CYP2D6 enzyme.  Avanir licensed exclusive worldwide rights
to AVP-786 from Concert Pharmaceuticals, Inc. 

About AVP-923

AVP-923 is a combination of two well-characterized compounds, the active CNS
ingredient dextromethorphan hydrobromide (an uncompetitive NMDA receptor
antagonist and sigma-1 receptor agonist) plus low-dose quinidine sulfate (a
CYP2D6 enzyme inhibitor), which serves to increase the bioavailability of
dextromethorphan.  AVP-923 is being studied in several ongoing clinical trials
including agitation in Alzheimer's disease, neuropathic pain in Multiple
Sclerosis, levodopa-induced dyskinesia in Parkinson's disease, and behavioral
symptoms of autism.

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 registered trademarks owned by Avanir
Pharmaceuticals, Inc.

^©2013 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.

Avanir Investor & Media Contact
Ian Clements, PhD
ir@avanir.com 
+1 (949) 389-6700

AVANIR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
                                                 December 31,   September 30,
                                                 2012           2012
                                                 (unaudited)    (audited)
ASSETS
Current assets:
     Cash and cash equivalents                   $  56,942,618  $   69,778,406
     Trade receivables, net                      6,834,022      7,231,759
     Inventories, net                            378,244        415,475
     Prepaid expenses and other current assets   4,085,903      2,434,590
     Current portion of restricted investments   1,054,463      1,054,463
in marketable securities 
          Total current assets                   69,295,250     80,914,693
Restricted investments in marketable securities, 1,303,938      1,302,136
net of current portion
Property and equipment, net                      1,789,140      1,808,594
Non-current inventories, net                     908,364        908,364
Other assets                                     665,159        1,078,009
       TOTAL ASSETS                              $  73,961,851  $   86,011,796
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
    Accounts payable, accrued expenses and other $  14,324,457  $   15,598,666
liabilities
    Deferred product revenues, net               -              -
    Current portion of note payble               4,949,972      2,162,263
    Current portion of deferred royalty revenues 2,557,464      2,557,464
       Total current liabilities                 21,831,893     20,318,393
Accrued expenses and other liabilities, net of   869,722        666,179
current portion
Note Payable                                     24,048,825     26,698,263
Deferred royalty revenues, net of current        1,017,247      1,491,854
portion
        Total liabilities                        47,767,687     49,174,689
         Total stockholders' equity              26,194,164     36,837,107
TOTAL LIABILITIES AND STOCKHOLDERS'  EQUITY      $  73,961,851  $   86,011,796

 

 

AVANIR PHARMACEUTICALS, INC.
CONDENSED STATEMENT OF OPERATIONS
                                      Three Months Ended December 31,
                                      2012                 2011
REVENUES
   Net product sales                  $  14,879,262        $    5,488,763
   Revenues from royalties            1,626,010            1,676,120
   Revenue from research grant        15,000               -
services
           Total revenues             16,520,272           7,164,883
OPERATING EXPENSES
   Cost of product sales              838,129              309,803
   Cost of research grant services    9,398                -
   Research and development           6,648,091            3,744,515
   Selling and marketing              13,522,419           13,782,836
   General and administrative         6,538,403            5,292,183
           Total operating expenses   27,556,440           23,129,337
Loss from operations                  (11,036,168)         (15,964,454)
OTHER INCOME (EXPENSE)
   Interest income                    19,331               14,291
   Interest expense                   (1,059,245)          -
   Other, net                         -                    4,006
Net loss and comprehensive loss       $ (12,076,082)       $ (15,946,157)
Basic and diluted net loss per share  $            (0.09)  $            (0.12)
Basic and diluted weighted average    136,772,557          127,934,257
number of common shares outstanding 

SOURCE Avanir Pharmaceuticals, Inc.

Website: http://www.avanir.com
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