Avanir Pharmaceuticals Reports Fiscal 2014 Second Quarter Financial and Business Results

   Avanir Pharmaceuticals Reports Fiscal 2014 Second Quarter Financial and
                               Business Results

PR Newswire

ALISO VIEJO, Calif., May 6, 2014

ALISO VIEJO, Calif., May 6, 2014 /PRNewswire/ --Avanir Pharmaceuticals, Inc.
(NASDAQ: AVNR) today reported financial results for the three and six months
ended March 31, 2014.

Avanir Pharmaceuticals, Inc.

Quarterly Financial Highlights

  oTotal company net revenues of $26.9 million
  oNet NUEDEXTA® sales of $24.4 million
  oCash, cash equivalents, and restricted investments of $56.5 million as of
    March 31, 2014.

"We are extremely pleased with the recent outcome of the NUEDEXTA ANDA
litigation," said Keith A. Katkin, president and CEO of Avanir. "With this
patent litigation behind us and 12-plus years of market exclusivity, we are
committed to investing in the NUEDEXTA business to maximize the long term
revenue potential. NUEDEXTA has brought relief to tens of thousands of
patients suffering from PBA and achieved its twelfth successive sequential
quarter over quarter growth. Through the remainder of 2014 we anticipate
reporting on important results from our two ongoing phase II studies and the
PRISM2 study."

Fiscal 2014 Second Quarter Results

  oTotal net revenues for the second quarter fiscal 2014 were $26.9 million,
    compared with $17.4 million for the comparable quarter in fiscal 2013,
    representing 55 percent year-over-year growth. Total net revenues consist
    of NUEDEXTA revenue, Abreva® royalties and co-promotion revenues.
  oTotal operating expenses were $38.7 million in the second quarter of
    fiscal 2014, compared with $32.9 million in the comparable period in
    fiscal 2013.
  oCash used in operations was $15.7 million in the second quarter of fiscal
    2014.
  oNet loss for the fiscal 2014 second quarter was $12.7 million, or $0.08
    per share, compared with a net loss of $16.5 million, or $0.12 per share,
    for the same period in fiscal 2013.

Fiscal 2014 Six-Month Results

  oTotal net revenues for the first six-months of fiscal 2014 totaled $53.7
    million, compared with $34.0 million for the first six months of fiscal
    2013.
  oTotal operating expenses were $75.5 million in the first six-months of
    fiscal 2014, compared to $60.5 million in the comparable period for fiscal
    2013.
  oCash used in operations was $25.5 million in the first six months of
    fiscal 2014.
  oNet loss for the first six-months of fiscal 2014 was $23.6 million, or
    $0.15 per share, compared with a net loss of $28.6 million, or $0.21 per
    share for the comparable period in fiscal 2013.

Cash, Cash Equivalents & Marketable Securities
As of March 31, 2014 Avanir had cash, cash equivalents and investments in
securities totaling $56.5 million, including cash and cash equivalents of
$53.9 million.

Quarter and Recent Business Highlights

  oSubmitted and received acceptance of a New Drug Application (NDA) to the
    U.S. Food and Drug Administration (FDA) for approval of AVP-825, the
    company's innovative Breath Powered™ investigational drug-device
    combination product for the acute treatment of migraine. The company has
    received a PDUFA date of November 26, 2014.
  oPresented data from a benchmark study of veterans with mild traumatic
    brain injury, showing that approximately 60 percent of 758 respondents
    reported PBA symptoms, characterized by the presence of involuntary,
    uncontrollable episodes of crying and/or laughing that were exaggerated or
    even contrary to how they felt at the time. In addition to patient burden,
    the data show that presence of PBA symptoms are associated with increased
    health care costs.
  oAnnounced the addition of Dr. Mark Corrigan to the company's board of
    directors.
  oAnnounced the publication of research showing dextromethorphan has
    antidepressant-like effects in vivo. The data shows that dextromethorphan
    exerts antidepressant-like actions mediated at least in part through
    sigma-1 receptors.
  oShowcased the company's central nervous system therapeutic franchise at
    the 66th Annual Meeting of the American Academy of Neurology.

Note to Investors: As previously announced, Avanir will hold a conference call
to discuss fiscal 2014 second quarter financial results today, May 6, 2014,
beginning at 1:30 p.m. Pacific Time. You can listen to this call by dialing 1
(866) 318-8614 for domestic callers or +1 (617) 399-5133 for international
callers, and entering passcode 89833749. Those interested in listening to the
conference call live via the internet may do so by visiting
http://ir.avanir.com.

About AVP-825
AVP-825 is an investigational drug-device combination product consisting of
low-dose sumatriptan powder delivered intranasally utilizing a novel Breath
Powered delivery technology. If approved, AVP-825 would be the first and only
fast-acting, dry-powder intranasal form of sumatriptan for the treatment of
migraine. AVP-825 is an investigational drug-device combination product not
approved by the FDA. In the phase III clinical trial the most common AEs
(incidence >5%) reported for AVP-825 were product taste (22%), nasal
discomfort (13%), and rhinitis (6%); local AEs were almost exclusively mild to
moderate in severity and transient. Sumatriptan is contraindicated for certain
patients, including those with a history of coronary artery disease (CAD) or
coronary vasospasm.

About AVP-786
AVP-786 is a novel investigational drug product consisting of a combination of
deuterium modified dextromethorphan and ultra-low dose quinidine, used as a
metabolic inhibitor. Incorporation of deuterium into specific positions of the
dextromethorphan molecule strengthens the chemical bonds and reduces
susceptibility to enzyme cleavage and first pass metabolism, but without
altering its pharmacology. AVP-786 is an investigational drug not approved by
the FDA.

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. Several dose strengths of AVP-923 are being studied in
multiple ongoing clinical trials including agitation in Alzheimer's disease,
and levodopa-induced dyskinesia in Parkinson's disease. AVP-923 at the 20/10
mg dose strength is approved by the FDA for the treatment of pseudobulbar
affect (PBA) and marketed under the trade name NUEDEXTA (see description
below). AVP-923 is an investigational drug not approved by the FDA for any
uses other than PBA.

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. 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.

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



AVANIR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
                                                    March 31,    September 30,
                                                    2014         2013
                                                    (unaudited)  (audited)
ASSETS
Current assets:
 Cash and cash equivalents                      $       $     
                                                    53,888,058   55,259,073
 Restricted cash and cash equivalents           1,318,033    965,986
 Trade receivables, net                         17,215,906   12,525,992
 Inventories, net                               640,853      710,179
 Prepaid expenses and other current assets      4,629,980    2,382,410
 Total current assets                      77,692,830   71,843,640
Restricted long-term investments                    1,303,580    1,303,938
Property and equipment, net                         3,153,568    1,592,791
Non-current inventories, net                        773,129      784,186
Other assets                                        686,154      554,452
 TOTAL ASSETS                                 $       $     
                                                    83,609,261   76,079,007
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
 Accounts payable, accrued expenses and other    $       $     
liabilities                                         26,902,884   25,560,756
 Current portion of note payble                  11,158,907   7,942,945
 Current portion of deferred royalty revenues    178,786      1,288,514
 Total current liabilities                    38,240,577   34,792,215
Accrued expenses and other liabilities, net of      2,019,000    1,393,075
current portion
Note Payable                                        15,696,511   21,422,163
 Total liabilities                           55,956,088   57,607,453
 Total stockholders' equity                 27,653,173   18,471,554
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY         $       $     
                                                    83,609,261   76,079,007

AVANIR PHARMACEUTICALS, INC.
CONDENSED STATEMENT OF OPERATIONS
                    Three Months Ended March 31,  Six Months Ended March 31,
                    2014           2013           2014           2013
REVENUES
 Net product      $           $           $            $    
sales               24,379,159    16,535,059    47,678,186    31,414,321
 Revenues from    475,281        899,129        2,564,595      2,525,139
royalties
 Revenue from
co-promotion with   2,092,264      -              3,450,342      -
Merck
 Revenue from
research grant      -              -              -              15,000
services
 Total    26,946,704     17,434,188     53,693,123     33,954,460
revenues
OPERATING EXPENSES
 Cost of product  1,370,001      933,426        2,662,412      1,771,555
sales
 Cost of research -              69,090         -              78,488
grant services
 Research and     9,892,256      8,874,298      19,417,576     15,522,389
development
 Selling and      18,904,244     16,061,408     36,379,648     29,583,827
marketing
 General and      8,555,381      6,978,684      17,005,271     13,517,087
administrative
 Total    38,721,882     32,916,906     75,464,907     60,473,346
operating expenses
Loss from           (11,775,178)   (15,482,718)   (21,771,784)   (26,518,886)
operations
OTHER INCOME
(EXPENSE)
 Interest income  4,987          15,065         9,539          34,396
 Interest expense (898,316)      (1,059,245)    (1,853,211)    (2,118,490)
 Other, net       (9,249)        197            (8,837)        197
Loss before
provision for       (12,677,756)   (16,526,701)   (23,624,293)   (28,602,783)
income taxes
 Provision for
income taxes
Net loss and        $            $            $             $  
comprehensive loss  (12,677,756)  (16,526,701)  (23,624,293)  (28,602,783)
Basic and diluted   $        $        $        $      
net loss per share    (0.08)       (0.12)      (0.15)         (0.21)
Basic and diluted
weighted average    154,633,853    139,173,746    153,353,200    137,959,958
number of common
shares outstanding

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SOURCE Avanir Pharmaceuticals, Inc.

Website: http://www.avanir.com
 
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