AVANIR Pharmaceuticals Reports Second Quarter of Fiscal 2006 Financial Results.SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. -- AVANIR Pharmaceuticals (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :AVNR AVNR Atrioventricular Nodal Reentry ) today reported unaudited financial results for the three months ended March 31, 2006, or second quarter of fiscal 2006. Second Quarter 2006 Results For the second quarter ended March 31, 2006, AVANIR's net loss was $13.4 million, or $0.43 per share, compared to $14.1 million, or $0.57 per share, for the same period in 2005. Higher overall revenues in the second quarter of fiscal 2006 offset a larger portion of AVANIR's operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. in the period, which contributed to the reduction in net loss compared with the same period a year ago. The lower loss per share in the current period was also due to a higher weighted average number of shares outstanding, compared to the same period in the prior year. The second quarter of fiscal 2006 was highlighted by the following activities: --Completion of the new drug application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Neurodex(TM) in the treatment of Involuntary involuntary adj. or adv. without intent, will, or choice. Participation in a crime is involuntary if forced by immediate threat to life or health of oneself or one's loved ones, and will result in dismissal or acquittal. INVOLUNTARY. Emotional Expression Disorder ("IEED IEED Involuntary Emotional Expression Disorder ") or pseudobulbar affect; --Receipt of approximately $4.7 million from the exercise of the Company's outstanding Class A Warrants that were called by the Company; --Implementation of a 1-for-4 reverse stock split, resulting in an improved capital structure; --Execution of a licensing agreement for docosanol 10% cream in Japan; --Continuation of transforming our business model from a research driven organization to a commercial pharmaceutical company in preparation for the anticipated launch of Neurodex; --Addition of two additional experienced executives to AVANIR's management team, a vice president of sales and a vice president of medical affairs; and --Receipt of a $5.0 million milestone (earned in the first fiscal quarter of 2006) from AstraZeneca related to filing an investigational new drug application and the initiation of Phase I safety studies with a small molecule reverse cholesterol compound. Subsequent to the close of the quarter, AVANIR: --Received notice of acceptance with Priority Review on the Neurodex NDA from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ; and --Commenced trading on the NASDAQ(R) National Market under the stock symbol AVNR. Revenues for the second quarter ended March 31, 2006 were $2.5 million, compared to $645,000 for the same period a year ago. The increase in revenues is primarily due to revenues from research and development services being provided by AVANIR in connection with license agreements with AstraZeneca and Novartis. Operating expenses for the second quarter ended March 31, 2006 were $16.4 million, compared with $14.8 million for the same period a year ago. The operating expenses for the second quarter ended March 31, 2006 included incremental Additional or increased growth, bulk, quantity, number, or value; enlarged. Incremental cost is additional or increased cost of an item or service apart from its actual cost. share-based compensation expense of $758,000, or $0.02 per share, resulting from the adoption of Statement of Financial Accounting Standards No. 123R ("FAS 123R"), Share-Based Payment, in the beginning of our fiscal 2006. Research and development ("R&D") expenses for the second quarter of fiscal 2006 amounted to $7.9 million, compared to $11.4 million for the same period a year ago, as the Company continued to advance its R&D programs. The second quarter ended March 31, 2005 included a $7.2 million charge related to the acquisition of additional contractual rights A contractual right is a claim, on other persons, that is acknowledged and perhaps reciprocated among the principals associated with that claim. Specialized contractual rights exist as part of a "contract" or agreement between persons to whom these rights belong. to Neurodex. Selling, general and administrative expenses for the second quarter of fiscal 2006 increased to $8.5 million, compared to $3.4 million for the same period a year ago. The increase is primarily due to the Company's expansion of awareness programs and market research for IEED, medical education, filling key management positions, and recognition of share-based compensation expense. As of March 31, 2006, AVANIR had cash, cash equivalents, and investments in securities totaling $53.0 million, compared to $27.5 million as of September 30, 2005. The higher overall level of cash and equivalents was primarily due to financing activities by the Company, the call of warrants, and exercises of stock options. Net working capital was $38.6 million, deferred revenue was $19.0 million and shareholders' equity Shareholders' Equity A firms' total assets minus its total liabilities. Equivalently, it is share capital plus retained earnings minus treasury shares. Shareholders' equity is the amount by which a company is financed through common and preferred shares. was $35.5 million as of March 31, 2006. Fiscal Year-to-date Results Net loss for the six months ended March 31, 2006 was $19.1 million, or $0.64 per share, compared to a net loss of $21.1 million, or $0.87 per share, for the same period a year ago. Revenues of $10.6 million for the first half of fiscal 2006 included the $5.0 million milestone from AstraZeneca, $4.4 million in research and services revenues, $1.0 million in revenues that the Company recognized from the sale of abreva(R) royalty rights, and $161,000 from government research grants. Revenues in the first half of fiscal 2005 amounted to $1.5 million, which included $928,000 in revenues recognized from the sale of abreva royalty rights, $300,000 in revenues relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc achievement of milestones under a license agreement for docosanol 10% cream, and $286,000 from government research grants. Total operating expenses for the first half of fiscal 2006 were $30.5 million, compared to $22.8 million in the same period a year ago. The operating expenses for the first half of fiscal 2006 included incremental share-based compensation expense of $1.2 million, or $0.04 per share, resulting from the adoption of FAS 123R in the beginning of our fiscal 2006. R&D expenses for the first half of fiscal 2006 amounted to $17.3 million, compared to $16.5 million for the same period a year ago. Selling, general and administrative expenses for the first half of fiscal 2006 increased to $13.3 million, compared to $6.3 million for the same period a year ago. Subsequent Event The Company also announced today that it would undergo a consolidation of its three leased office and lab-based facilities in San Diego. By consolidating the Company's research and development operations into one of the existing San Diego facilities, relocating office support and commercial employees to more suitable office space in Orange County, reducing utilized facility square footage by over 20%, and subleasing excess space, the Company expects to save approximately $1.0 million in the aggregate in operating activities over a three-year period, net of restructuring charges restructuring charge The expense of reorganizing a company's operations. A restructuring charge is an infrequent expense that generally results from asset writedowns or facility closings. . In connection with the consolidation, the Company expects to incur To become subject to and liable for; to have liabilities imposed by act or operation of law. Expenses are incurred, for example, when the legal obligation to pay them arises. An individual incurs a liability when a money judgment is rendered against him or her by a court. approximately $2.0-$2.5 million in restructuring charges over the next twelve months. The Company expects the facilities realignment re·a·lign tr.v. re·a·ligned, re·a·lign·ing, re·a·ligns 1. To put back into proper order or alignment. 2. To make new groupings of or working arrangements between. to be completed over the next 6-12 months. Conference Call and Webcast Management will host a conference call with simultaneous webcast on May 8th at 1:30 p.m. Pacific/ 4:30 p.m. Eastern to discuss second quarter and year-to-date fiscal 2006 operating performance. The webcast can be accessed on AVANIR's web site at www.avanir.com. For those who cannot listen to the live broadcast, the online replay will be available for 30 days, and a phone replay will be available through May 15, 2006, by dialing (800) 642-1687 for domestic callers and (706) 645-9291 for international callers and entering the passcode 8238299. About AVANIR AVANIR Pharmaceuticals is focused on developing, acquiring, and commercializing novel therapeutic products for the treatment of chronic diseases. AVANIR's product candidates address therapeutic markets that include central nervous system and cardiovascular cardiovascular /car·dio·vas·cu·lar/ (-vas´ku-ler) pertaining to the heart and blood vessels. car·di·o·vas·cu·lar adj. Abbr. disorders, inflammation inflammation, reaction of the body to injury or to infectious, allergic, or chemical irritation. The symptoms are redness, swelling, heat, and pain resulting from dilation of the blood vessels in the affected part with loss of plasma and leucocytes (white blood , and infectious diseases infectious diseases: see communicable diseases. . AVANIR previously announced and published positive results from the two required Phase III clinical trials Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the for Neurodex(TM), an investigational new drug for the treatment of involuntary emotional expression disorder currently under priority review with the FDA. Additionally, AVANIR has initiated a Phase III clinical trial for Neurodex as a potential treatment in patients with diabetic diabetic /di·a·bet·ic/ (-bet´ik) 1. pertaining to or affected with diabetes. 2. a person with diabetes. di·a·bet·ic adj. 1. neuropathic neuropathic /neu·ro·path·ic/ (-path´ik) pertaining to or characterized by neuropathy. neuropathic pertaining to disease of the nervous system. pain, a second indication for Neurodex. AVANIR has active collaborations with two international pharmaceutical companies: Novartis International Pharmaceutical Ltd. for the treatment of inflammatory disease Noun 1. inflammatory disease - a disease characterized by inflammation disease - an impairment of health or a condition of abnormal functioning NEC, necrotizing enterocolitis - an acute inflammatory disease occurring in the intestines of premature infants; and AstraZeneca for the treatment of cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease . The Company's first commercialized product, abreva(R), is marketed in North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores cold sore: see herpes simplex. . Further information about AVANIR can be found at www.avanir.com. Forward Looking Statements The information contained in this press release, including any forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. contained herein, should be reviewed in conjunction with the company's most recent Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and quarterly report on Form 10-Q Form 10-Q See 10-Q. and other publicly available information regarding the Company. Copies of such information are available from the company upon request. Such publicly available information sets forth many risks and uncertainties related to the company's business and technology. Forward-looking statements often contain such words like "estimate," "anticipate," "believe," "plan" or "expect". AVANIR disclaims any intent or obligation to update these forward-looking statements.
AVANIR Pharmaceuticals
Summary Consolidated Financial Information
(Unaudited)
Quarters ended March 31, Six months ended March 31,
--------------------------- ---------------------------
Statement of
operations
data: 2006 2005 2006 2005
-------- ------------- ------------- ------------- -------------
Revenues $2,469,028 $644,733 $10,613,916 $1,533,098
------------- ------------- ------------- -------------
Expenses
Research and
development 7,919,847 11,428,170 17,283,249 16,482,411
Selling,
general and
administrative 8,492,115 3,372,183 13,260,858 6,323,186
Cost of sales -- -- -- 3,102
------------- ------------- ------------- -------------
Total
operating
expenses 16,411,962 14,800,353 30,544,107 22,808,699
------------- ------------- ------------- -------------
Loss from
operations (13,942,934) (14,155,620) (19,930,191) (21,275,601)
Interest
income 564,422 125,147 892,588 246,979
Other income
(expense) (5,492) 4,850 5,020 (62,071)
Interest
expense (21,403) (25,324) (44,841) (46,945)
------------- ------------- ------------- -------------
Loss
before
income
taxes (13,405,407) (14,050,947) (19,077,424) (21,137,638)
Income tax
benefit
(provision) (4) - (2,421) (1,898)
------------- ------------- ------------- -------------
Net loss $(13,405,411) $(14,050,947) $(19,079,845) $(21,139,536)
============= ============= ============= =============
Net loss per
share:
Basic and
diluted $(0.43) $(0.57) $(0.64) $(0.87)
============= ============= ============= =============
Weighted
average number
of common
shares:
Basic and
diluted 31,086,874 24,565,682 29,819,338 24,261,024
============= ============= ============= =============
March September
31, 30,
2006 2005
------------ ------------
Balance sheet data:
-------------------
Cash and cash equivalents $10,912,580 $8,620,143
Short-term, long-term and restricted
investments in securities 42,041,676 18,917,443
------------ ------------
Total cash and investments in securities $52,954,256 $27,537,586
Net working capital $38,602,472 $11,969,450
Total assets $66,985,222 $41,401,990
Deferred revenue $18,999,961 $19,158,210
Total liabilities $31,519,800 $32,267,111
Shareholders' equity $35,465,422 $9,134,879
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