ALISO VIEJO, Calif., Aug. 8, 2011 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today reported financial results for the three and nine months ended June 30, 2011.
Quarterly Financial Highlights
"I am thrilled with the progress we are making in the early phase of the NUEDEXTA launch," said Keith A. Katkin, president and CEO of Avanir. "We have seen significant growth in prescription numbers since launch. It is clear that the doctors who are called on most frequently are driving our growth, which indicates that the PBA market is highly promotionally sensitive. We look forward to focusing our promotional resources on the areas of highest opportunity and building on the initial success of NUEDEXTA as we build Avanir into a leading CNS specialty biopharmaceutical company."
Fiscal 2011 Third Quarter Results
NUEDEXTA RevenueFor the quarter ended June 30, 2011, the company reported NUEDEXTA gross and net revenue of $2.2 million and $1.9 million respectively. NUEDEXTA revenue is recognized using a deferred revenue recognition model, meaning that NUEDEXTA capsule shipments to wholesalers are initially recorded as deferred revenue and later recognized as revenue when the product has left the distribution channel and is no longer subject to a right of return, effectively representing reported end-user prescriptions and non-retail shipments of NUEDEXTA capsules.
Business HighlightsRecent highlights for the company include:
Cash, Cash Equivalents & Marketable SecuritiesAs of June 30, 2011 Avanir had cash, cash equivalents and investments in securities totaling $93.5 million, including cash and cash equivalents of $91.3 million and restricted investments in securities of $2.2 million.
Note to Investors: As previously announced, Avanir will hold a conference call to discuss fiscal 2011 third quarter financial results today, August 8, 2011, beginning at 1:30 p.m. Pacific Time. You can listen to this call by dialing 1-877-558-3407 for domestic callers or +1-706-679-1941 for international callers, and entering passcode 87076138. Those interested in listening to the conference call live via the internet may do so by visiting http://www.avanir.com.
About NUEDEXTANUEDEXTA® is the first and only FDA-approved treatment for pseudobulbar affect (PBA). 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 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 patient's 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. The primary outcome measure, laughing and crying episodes, was significantly lower in the NUEDEXTA arm compared to placebo. The secondary outcome measure, the Center for Neurologic Studies Lability Scale (CNS-LS), demonstrated a significantly greater mean decrease in CNS-LS score from baseline for the NUEDEXTA arm compared to placebo.
NUEDEXTA Important Safety InformationNUEDEXTA can interact with other medications causing significant changes in blood levels of those medications and/or NUEDEXTA. NUEDEXTA is contraindicated in patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide) and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine. NUEDEXTA is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs within the preceding 14 days. NUEDEXTA is contraindicated in patients with a known hypersensitivity to its components.
NUEDEXTA may cause serious side effects, including possible changes in heart rhythm. NUEDEXTA is contraindicated in patients with a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes, in patients with heart failure as well as patients with, or at risk of, complete atrioventricular (AV) block, unless the patient has an implanted pacemaker.
NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk of QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation of QT interval should be conducted at baseline and 3-4 hours after the first dose.
The most common adverse reactions in patients taking NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, swelling of feet and ankles, urinary tract infection, flu, elevated liver enzymes, 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.
Patients should take NUEDEXTA exactly as prescribed. Patients should not take more than 2 capsules in a 24-hour period, make sure that there is an approximate 12-hour interval between doses, and not take a double dose after they miss a dose.
These are not all the risks from use of NUEDEXTA. For additional important safety information about NUEDEXTA, please see the full Prescribing Information at www.NUEDEXTA.com.
About PBAPatients suffering from existing neurological disease or brain injury may also suffer the added burden of pseudobulbar affect, or 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 patient's underlying emotional state. PBA outbursts result from a "short circuit" in the brain caused by another neurologic condition--such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), stroke, or traumatic brain injury. PBA can have a debilitating impact on the lives of patients, caregivers and loved ones. For more information about PBA, please visit www.PBAinfo.org.
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 trademarks owned by Avanir Pharmaceuticals, Inc.
©2011 Avanir Pharmaceuticals, Inc. All Rights Reserved.
Forward Looking StatementsExcept 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 and maintaining regulatory approvals domestically and internationally, including, but not limited to potential regulatory delays or rejections in the filing or acceptance of the Marketing Authorization Application, delay or failure to file under an accelerated review process, uncertainty regarding use of the data package which served as the basis for the U.S. FDA approval, delay or failure to reach an agreement on a pediatric investigation plan, uncertainty of the filing, review and approval process under a centralized procedure, risks associated with meeting the objectives of the PRIME study, including, but not limited to, delays or failures in enrollment, and the occurrence of adverse safety events, 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 PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)Three Months Ended June 30,Nine Months Ended June 30,2011201020112010REVENUES FROM PRODUCT SALES Gross product sales
- Less: discount and allowances
(254,889)-(297,841)- Net product sales
1,932,235-2,394,249- Cost of product sales
119,20880,000233,53580,000Product gross margin (deficit)
1,813,027(80,000)2,160,714(80,000)OTHER REVENUES Revenues from royalties
547,900487,3503,340,8762,966,778Total gross margin
2,360,927407,3505,501,5902,886,778OPERATING EXPENSES Research and development
3,258,9502,788,1329,622,12910,050,635 Selling, general and administrative
15,150,0533,733,15138,522,26410,222,333Total operating expenses
18,409,0036,521,28348,144,39320,272,968Loss from operations(16,048,076)(6,113,933)(42,642,803)(17,386,190)OTHER INCOME (EXPENSE) Interest income
10,8482,66128,03110,822 Other, net
(28,332)389,689(28,295)390,366Net loss$ (16,065,560)$ (5,721,583)$ (42,643,067)$ (16,985,002)Basic and diluted net loss per share$
(0.20)Basic and diluted weighted average number of common shares outstanding
123,354,98689,347,783117,747,18585,307,980AVANIR PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETSJune 30, September 30,20112010(unaudited)(audited)ASSETSCurrent assets:Cash and cash equivalents
700,562652,628Other current assets
3,210,8281,066,482Current portion of restricted investments in marketable securities
617,100200,000Total current assets
96,388,42540,690,579Restricted investments in marketable securities, net of current portion
1,634,625401,550Property and equipment, net
1,013,864371,150TOTAL ASSETS$ 100,417,830$
42,141,198LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities:Accounts payable, accrued expenses and other liabilities
5,323,542Deferred product revenues, net
1,583,890-Current portion of deferred royalty revenues
2,087,2262,399,849Total current liabilities
10,522,5487,723,391Accrued expenses and other liabilities, net of current portion
144,667334,269Deferred royalty revenues, net of current portion
15,394,42814,134,642Total stockholders' equity
85,023,40228,006,556TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY$ 100,417,830$
|SOURCE Avanir Pharmaceuticals, Inc.|
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