AVANIR Pharmaceuticals Reports First Quarter of Fiscal Year 2004 Results
SAN DIEGO--(BUSINESS WIRE)--Feb. 12, 2004--AVANIR Pharmaceuticals (AMEX: AVN) today reported financial results for the first quarter of fiscal 2004, ended December 31, 2003. AVANIR reported a net loss for the first quarter of $6.3 million, or $0.09 per share, compared to a net loss of $4.2 million, or $0.07 per share, for the same period a year ago.
The first quarter was highlighted by:
- Marketing approval of docosanol 10% cream in Sweden, AVANIR'S
lead country in the mutual recognition process within Europe;
- An increase in enrollment in AVANIR's Phase III clinical trial
of Neurodex(TM) for the treatment of pseudobulbar affect (PBA)
in patients with multiple sclerosis, (enrollment was over 90%
complete as of February 6, 2004);
- Execution of a commercial license agreement with Peregrine
Pharmaceuticals, Inc. for an antibody generated to a cancer
target in Peregrine's product pipeline;
- A report of interim results of AVANIR's clinical trial of AVP
13358 that showed the experimental asthma/allergy drug was
well-tolerated at initial single rising doses in a randomized,
placebo-controlled Phase I clinical trial for safety and
- The presentation of new data on AVANIR's panel of human antibodies against the key toxin of anthrax and the award of a grant from the National Institute of Allergy and Infectious Diseases (NIAID) to further develop and characterize anthrax antibodies.
Total operating expenses for the first quarter of fiscal 2004 were $7.8 million, compared to $5.1 million in the same period a year ago. Expenditures on research and development (R&D) programs accounted for 68% and 71% of total operating expenses for the quarters ended December 31, 2003 and 2002, respectively. R&D expenses for the first quarter of fiscal 2004 amounted to $5.4 million, compared to $3.6 million for the same period a year ago.
AVANIR is currently in late stage clinical development of Neurodex(TM) for the treatment of PBA, also known as emotional lability, and expects to complete enrollment in the Phase III clinical trial in the second fiscal quarter ending March 31, 2004. In the first quarter, AVANIR also had expenses related to the continued clinical development of treatments for neuropathic pain (Phase II) and allergy and asthma (Phase I) and preclinical development of treatments for high cholesterol and inflammatory and infectious diseases. A comparison of R&D spending by program is shown in the table that follows. ------
RESEARCH AND DEVELOPMENT PROGRAM EXPENSES First Fiscal Quarter Ended December 31, December 31, 2003 2002 Amount Percent Amount Percent (Mils.) (Mils.) Develop Neurodex for the treatment of PBA $1.8 33% $0.6 16% Develop Neurodex for neuropathic pain 0.6 11% 0.1 3% Development program for allergy and asthma (IgE regulator) 1.1 20% 1.2 34% Preclinical anti-inflammatory research program (MIF inhibitor) 0.6 11% 0.6 17% Other preclinical research, including cholesterol, antibody and antiviral research 1.3 25% 1.1 30% Total $5.4 100.0% $3.6 100.0%
Revenues of $1.5 million for the first quarter of fiscal 2004 included $770,000 from sales of the active ingredient docosanol to licensees, $536,000 in revenues that the Company recognized from the sale of Abreva(R) royalty rights to Drug Royalty USA, and $198,000 from government research grants.
Balance sheet highlights
As of December 31, 2003, AVANIR had cash, cash equivalents, and investments in securities totaling $18.5 million, compared to $17.5 million as of September 30, 2003. Net working capital balance was $11.7 million, deferred revenue was $22.3 million and shareholders' equity was $2.3 million as of December 31, 2003. AVANIR completed a stock offering on December 5, 2003, resulting in net proceeds of $7.6 million from the sale of Class A common stock and warrants.
The 2004 Annual Meeting of Shareholders of AVANIR Pharmaceuticals will be held on March 18th, 2004 at 10:00 a.m. at the Company's Conference Center, located at 11404 Sorrento Valley Road, San Diego, California. All shareholders are cordially invited to attend the meeting.
Conference Call and Webcast
Management will host a conference call with a simultaneous webcast today at 10 a.m. Pacific/ 1 p.m. Eastern to discuss first quarter of fiscal 2004 operating performance. The call/webcast will feature President and Chief Executive Officer Gerald J. Yakatan, Ph.D., and Vice President and Chief Financial Officer Gregory P. Hanson, CMA. The webcast will be available live via the Internet by accessing AVANIR's web site at www.avanir.com or CCBN's www.companyboardroom.com. Please go to either web site at least ten minutes early to register, download and install any necessary audio software. Replays of the webcast will be available for 90 days, and a phone replay will be available through February 19, 2004, by dialing 888-266-2086 and entering the passcode # 389536.
AVANIR Pharmaceuticals, based in San Diego, is a drug discovery and development company focused primarily on novel treatments for chronic diseases. The Company's most advanced product candidate, Neurodex(TM), is in Phase III clinical development for pseudobulbar affect, also known as emotional lability. Neurodex is also in Phase II clinical development for neuropathic pain. A potential treatment for allergy and asthma, AVP-13358, is in Phase I clinical development. AVANIR also develops human monoclonal antibodies for infectious diseases and other therapeutic applications. The Company's first commercialized product, Abreva(R), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores.
Except for the historical information presented herein, matters discussed in this press release contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements that are preceded by, followed by, or that include such words like "estimate," "anticipate," "believe," "intend," "plan," or "expect" or similar statements are forward-looking statements. In regard to financial projections, risks and uncertainties include risks associated with milestones and royalties earned from licensees, and results of clinical trials or product development efforts, as well as risks shown in the Company's Annual Report on Form 10-K and from time-to-time in other publicly available information regarding the Company. Copies of such information are available from AVANIR upon request. Such publicly available information sets forth many risks and uncertainties related to AVANIR's business and technology. The company disclaims any intent or obligation to update these forward-looking statements. ------
AVANIR PHARMACEUTICALS Summary Consolidated Financial Information (Unaudited) Three Months Ended December 31, Consolidated Statement of Operations Data: 2003 2002 Revenues $1,509,645 $819,106 Operating expenses Research and development 5,363,683 3,611,622 General and administrative 1,407,896 1,078,946 Sales and marketing 858,511 425,129 Cost of product sales 210,090 3,102 Total operating expenses 7,840,180 5,118,799 Loss from operations (6,330,535) (4,299,693) Interest income 55,542 68,022 Other income 7,647 5,846 Interest expense (10,808) (10,574) Loss before income taxes (6,278,154) (4,236,399) Provision for income taxes (2,058) (1,600) Net loss $(6,280,212) $(4,237,999) Net loss attributable to common shareholders $ (6,280,212) $ (4,248,858) Net loss per share: Basic and diluted $(0.09) $(0.07) Weighted average number of common shares outstanding: Basic and diluted 67,804,604 58,296,555 Consolidated Balance Sheet Data: December 31, September 30, 2003 2003 Cash and cash equivalents $ 12,989,511 $ 12,198,408 Short-term, long-term and restricted investments in securities 5,519,922 5,258,881 Total cash and investments $18,509,433 $17,457,289 Net working capital $11,684,361 $10,619,216 Total assets $30,786,587 $29,645,257 Deferred revenue $22,257,036 $22,792,641 Total liabilities $28,493,998 $28,608,026 Shareholders' equity $2,292,589 $1,037,231
CONTACT: AVANIR Pharmaceuticals
Patrice Saxon, 858-622-5202
SOURCE: AVANIR Pharmaceuticals