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 firstname.lastname@example.org +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
Avanir Pharmaceuticals Reports Fiscal 2014 Second Quarter Financial and Business Results
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