ALISO VIEJO, Calif., Aug. 5, 2014 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today reported financial results for the three and nine months ended June 30, 2014.
Quarterly Financial Highlights
"We had a great quarter across all aspects of our business. I am delighted with the positive outcome of our ANDA patent litigation, solid revenue growth of 45% year-over-year, and the positive interim data from our open label PRISM II study in PBA and COMPASS clinical trial in migraine," said Keith A. Katkin, president and CEO of Avanir. "The future looks very promising as we are in the midst of expanding the sales force which should further accelerate revenue growth and we will announce data from our agitation and levodopa-induced dyskinesia trials later this year."
Fiscal 2014 Third Quarter Results
Fiscal 2014 Nine-Month Results
Cash, Cash Equivalents & Marketable SecuritiesAs of June 30, 2014 Avanir had cash, cash equivalents and investments in securities totaling $87.6 million, including cash and cash equivalents of $85.0 million.
Quarter and Recent Business Highlights
Note to Investors: As previously announced, Avanir will hold a conference call to discuss fiscal 2014 third quarter financial results today, August 5, 2014, beginning at 1:30 p.m. Pacific Time. You can listen to this call by dialing 1 (877) 474-9503 for domestic callers or +1 (857) 244-7556 for international callers, and entering passcode 33730262. Those interested in listening to the conference call live via the internet may do so by visiting http://ir.avanir.com.
About AVP-825AVP-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-786AVP-786 is a novel investigational drug product consisting of a combination of deuterium modified dextromethorphan (an uncompetitive NMDA receptor antagonist, sigma-1 receptor agonist and inhibitor of the serotonin transporter (SERT) and norepinephrine (NET) transporter) and ultra-low dose quinidine (a CYP2D6 enzyme 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-923AVP-923 is a combination of two well-characterized compounds, the active CNS ingredient dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist, sigma-1 receptor agonist and inhibitor of the serotonin transporter (SERT) and norepinephrine (NET) transporter) plus low-dose quinidine sulfate (a CYP2D6 enzyme inhibitor), which serves to increase the bioavailability of dextromethorphan. AVP-923 is being studied in several ongoing company sponsored Phase II clinical trials including agitation in Alzheimer's disease, levodopa-induced dyskinesia in Parkinson's disease, and multiple investigator initiated studies. AVP-923 is an investigational drug not approved by the FDA. 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 NUEDEXTANUEDEXTA 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 InformationNUEDEXTA 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 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 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
+1 (949) 389-6700AVANIR PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETSJune 30,September 30,20142013(unaudited)(audited)ASSETSCurrent assets:Cash and cash equivalents
55,259,073Restricted cash and cash equivalents
1,319,030965,986Trade receivables, net
685,785710,179Prepaid expenses and other current assets
4,252,3312,382,410Total current assets
112,593,58471,843,640Restricted long-term investments
1,304,0651,303,938Property and equipment, net
3,184,2061,592,791Non-current inventories, net
670,641554,452TOTAL ASSETS$ 118,445,414$
76,079,007LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities:Accounts payable, accrued expenses and other liabilities
25,560,756Current portion of note payble
11,455,1557,942,945Current portion of deferred royalty revenues
-1,288,514Total current liabilities
36,846,15634,792,215Accrued expenses and other liabilities, net of current portion
51,729,99157,607,453Total stockholders' equity
66,715,42318,471,554TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY$ 118,445,414$
76,079,007AVANIR PHARMACEUTICALS, INC.CONDENSED STATEMENT OF OPERATIONSThree Months Ended June 30,Nine Months Ended June 30,2014201320142013REVENUESNet product sales
$ 26,540,131$ 19,044,28874,218,31750,458,609Revenues from royalties
178,786714,3742,743,3813,239,513Revenue from co-promotion with Merck
1,801,925-5,252,267-Revenue from research grant services
28,630,84219,758,66282,323,96553,713,122OPERATING EXPENSESCost of product sales
1,491,3191,077,7364,153,7312,849,291Cost of research grant services
198,039-198,03978,488Research and development
12,300,4836,053,68431,718,05921,576,073Selling and marketing
19,023,44416,005,75055,403,09245,589,577General and administrative
7,509,8727,031,61524,515,14320,548,702Total operating expenses
40,523,15730,168,785115,988,06490,642,131Loss from operations(11,892,315)(10,410,123)(33,664,099)(36,929,009)OTHER INCOME (EXPENSE)Interest income
-(228)(8,837)(31)Loss before provision for income taxes(12,698,763)(11,424,630)(36,323,056)(40,027,413)Provision for income taxesNet loss and comprehensive loss$ (12,698,763)$ (11,424,630)$ (36,323,056)$ (40,027,413)Basic and diluted net loss per share$
(0.29)Basic and diluted weighted average number of common shares outstanding
|SOURCE Avanir Pharmaceuticals, Inc.|
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