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
"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
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.
Recent highlights for the company include:
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 http://ir.avanir.com.
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 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.
©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
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
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
26,698,263-Deferred royalty revenues, net of current portion
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
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
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
-(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.|
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