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  Logo - http://photos.prnewswire.com/prnh/20130207/LA55901LOGO  SOURCE Avanir Pharmaceuticals, Inc.  Website: http://www.avanir.com  
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