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Avanir Pharmaceuticals Reports Fiscal 2012 Fourth Quarter And Year-End Financial And Business Results

ALISO VIEJO, Calif., Dec. 12, 2012 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today reported financial results for the three and twelve months ended September 30, 2012.

Quarterly Financial Highlights

  • Gross and net NUEDEXTA® sales of $15.4 million and $12.4 million, respectively, an increase of 26% and 23% versus the previous quarter
  • Total company net revenue of $13.5 million
  • Cash, cash equivalents, and restricted investments of $72.1 million as of September 30, 2012
  • "Our business has very good momentum as we are executing our strategy to grow revenues and deliver much needed therapies to patients. In addition to growing the PBA franchise, we are investing in our pipeline to develop several breakthrough therapies for the future, which are important steps to becoming a leading mid-cap CNS company. The clinical trials are continuing to enroll, and investments in R&D should, if successful, result in value generating inflection points in the coming years," said Keith A. Katkin, president and CEO of Avanir.

    Fiscal 2012 Fourth Quarter Results

  • Total net revenue for the quarter ended September 30, 2012 were $13.5 million, compared with $4.8 million for the comparable quarter in 2011; total net revenues consist of NUEDEXTA net revenue and royalty revenue from Abreva®
  • Total operating expenses were $24.2 million in the fourth quarter of fiscal 2012, compared with $22.7 million in the comparable period in fiscal 2011
  • Cash used in operations was $12.1 million in the fourth quarter of fiscal 2012
  • Net loss for the fiscal 2012 fourth quarter was $11.7 million, or $0.09 per share, compared with a net loss of $18.0 million, or $0.14 per share, for the same period in fiscal 2011
  • Twelve-Month Results

  • Total revenues for fiscal 2012 were $41.3 million, compared with $10.5 million for fiscal 2011
  • Total operating expenses for fiscal 2012, excluding cost of sales and share-based compensation, were $92.7 million; total operating expenses were $99.7 million for fiscal 2012
  • Cash used in operations was $57.7 million in fiscal 2012
  • Net loss for fiscal 2012 was $59.7 million, or $0.45 net loss per share, compared with a net loss of $60.6 million, or $0.51 net loss per share for fiscal 2011
  • Cash, Cash Equivalents & Marketable Securities
    As of September 30, 2012 Avanir had cash, cash equivalents and investments in securities totaling $72.1 million, including cash and cash equivalents of $69.8 million and restricted investments in securities of $2.3 million.

    Business Highlights
    Recent highlights for the company include:

  • Achieved record NUEDEXTA prescriptions of 31,018 for the quarter ended September 30, 2012.
  • On September 4, 2012, the company announced the enrollment of the first patient in study AVR-131. The study is a Phase II clinical trial investigating the use of AVP-923 for the treatment of agitation in patients with Alzheimer's disease.
  • In the fourth quarter of fiscal 2012 the company completed a sales force expansion and realignment bringing the total number of sales representatives to 130.
  • On October 23, 2012, the company announced that The Michael J. Fox Foundation had awarded the company a grant to evaluate the safety and efficacy of AVP-923 (dextromethorphan hydrobromide and quinidine sulfate) for the treatment of levodopa-induced-dyskinesia (LID) in Parkinson's disease (PD).
  • In November 2012, we initiated the first-in-human Phase I clinical trial of AVP-786 (formerly known as deuterated dextromethorphan). The trial is designed to assess the single and multiple dose pharmacokinetics, safety and tolerability of AVP-786 administered to healthy subjects.
  • Note to Investors: As previously announced, Avanir will hold a conference call to discuss fiscal 2012 fourth quarter and year-end financial results today, December 12, 2012, beginning at 1:30 p.m. Pacific Time. You can listen to this call by dialing 1 (866) 314-5050 for domestic callers or +1 (617) 213-8051 for international callers, and entering passcode 16033129. Those interested in listening to the conference call live via the Internet may do so by visiting

    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 (dextromethorphan hydrobromide and quinidine sulfate) 20/10 mg capsules can interact with other medications causing significant changes in blood levels of those medications and/or NUEDEXTA which may lead to serious side effects. Adjust dose or use alternate treatment of the other medication when clinically indicated.

    NUEDEXTA is contraindicated in patients concomitantly taking: QT-prolonging drugs metabolized by CYP2D6 (e.g., thioridazine and pimozide); monoamine oxidase inhibitors (MAOIs) within the preceding or following 14 days; other drugs containing quinidine, quinine, or mefloquine and in patients with a known hypersensitivity to these drugs or any of NUEDEXTA's components. Discontinue use of NUEDEXTA if hepatitis, thrombocytopenia, serotonin syndrome or a hypersensitivity reaction occurs.

    NUEDEXTA is contraindicated in patients with certain risk factors for arrhythmia: Prolonged QT interval; congenital long QT syndrome, history suggestive of torsades de pointes; heart failure; complete atrioventricular (AV) block or risk of AV block without an implanted pacemaker.

    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. Risk factors include left ventricular hypertrophy or dystrophy or concomitant use of drugs that prolong QT interval or certain CYP3A4 inhibitors.

    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. Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls.

    These are not all the risks from use of NUEDEXTA. Please refer to the accompanying full Prescribing Information or visit

    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

    Avanir® and NUEDEXTA® are registered trademarks owned by Avanir Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.

    ©2012 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 for commercially marketed products domestically and internationally, 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
    +1 (949) 389-6700


     AVANIR PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETSSeptember 30,September 30,20122011(unaudited)(audited)ASSETSCurrent assets:Cash and cash equivalents

    $   69,778,406$   79,542,564Trade receivables, net

    7,231,7592,011,165Inventories, net

    415,475252,244Prepaid expenses and other current assets

    2,434,5901,965,748Current portion of restricted investments in marketable securities 

    1,054,463618,314Total current assets

    80,914,69384,390,035Restricted investments in marketable securities, net of current portion

    1,302,1361,634,625Property and equipment, net

    1,808,5941,695,329Non-current inventories, net

    908,364792,933Other assets

    1,078,0091,136,072TOTAL ASSETS$   86,011,796$   89,648,994LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities:Accounts payable, accrued expenses and other liabilities

    $   15,598,666$   10,449,427Deferred product revenues, net

    -1,652,788Current portion of note payble

    2,162,263-Current portion of deferred royalty revenues

    2,557,4642,087,226Total current liabilities

    20,318,39314,189,441Accrued expenses and other liabilities, net of current portion

    666,17968,487Note Payable

    26,698,263-Deferred royalty revenues, net of current portion

    1,491,8544,051,402Total liabilities

    49,174,68918,309,330Total stockholders' equity

    36,837,10771,339,664TOTAL LIABILITIES AND STOCKHOLDERS'  EQUITY$   86,011,796$   89,648,994 

     AVANIR PHARMACEUTICALS, INC.CONDENSED STATEMENT OF OPERATIONSThree Months Ended September 30,Twelve Months Ended September 30,2012201120122011REVENUES AND COSTS FROM PRODUCT SALESGross product sales

    $  15,431,249$
    4,322,688$  45,107,989$
    7,014,778Less: discounts and allowances

    3,037,891627,6318,033,422925,472Net product sales

    12,393,3583,695,05737,074,5676,089,306Revenues from royalties

    1,138,4481,065,7134,200,5064,406,589Total revenues

    13,531,8064,760,77041,275,07310,495,895OPERATING EXPENSESCost of product sales

    712,546212,4452,120,221445,980Research and development

    6,095,1615,631,61023,066,03715,253,739Selling, general and administrative

    17,399,70416,903,32774,490,99655,425,591Total operating expenses

    24,207,41122,747,38299,677,25471,125,310Loss from operations(10,675,605)(17,986,612)(58,402,181)(60,629,415)OTHER INCOME (EXPENSE)Interest income

    12,75210,75442,81538,785Interest expense

    (1,059,244)(1,385,342)Other, net

    -(9,438)4,081(37,733)Loss before provision for income taxes(11,722,097)(17,985,296)(59,740,627)(60,628,363)Provision for income taxes

    3,2003,2003,2003,200Net loss and comprehensive loss$ (11,725,297)$ (17,988,496)$ (59,743,827)$ (60,631,563)Basic and diluted net loss per share$
    (0.51)Basic and diluted weighted average number of common shares outstanding 


    SOURCE Avanir Pharmaceuticals, Inc.
    Copyright©2012 PR Newswire.
    All rights reserved

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