8-K

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of Earliest Event Reported): February 12, 2004

AVANIR PHARMACEUTICALS

(Exact Name of Registrant as Specified in Charter)

California	001-15803	33-0314804
(State of Incorporation or Organization)	(Commission File Number)	(I.R.S. Employer Identification No.)

11388 Sorrento Valley Road, Suite 200, San Diego, California	92121
(Address of Principal Executive Offices)	(Zip Code)

     Registrant’s telephone number, including area code: (858) 622-5200

NOT APPLICABLE

(Former Name or Former Address, if Changed Since Last Report)

TABLE OF CONTENTS

	Item 7. Financial Statements and Exhibits.
	Item 12. Results of Operations and Financial Condition.
SIGNATURE
EXHIBIT INDEX
EXHIBIT 99.1

Item 7. Financial Statements and Exhibits.

     Exhibit

99.1 Press release, dated February 12, 2004

Item 12. Results of Operations and Financial Condition.

On February 12, 2004, AVANIR Pharmaceuticals issued a press release announcing its results of operations for the quarter ended December 31, 2003. A copy of the press release is furnished herewith as Exhibit 99.1.

The information in this Form 8-K and the Exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

SIGNATURE

     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Dated: February 12, 2004
	AVANIR	PHARMACEUTICALS
	By:	/s/ Gregory P. Hanson
		Gregory P. Hanson Chief Financial Officer

EXHIBIT INDEX

Exhibit No.	Description
99.1	Press release, dated February 12, 2004

EX-99.1 3 a96440exv99w1.txt EXHIBIT 99.1 EXHIBIT 99.1 [AVANIR LOGO] NEWS RELEASE FOR IMMEDIATE RELEASE Contact: At Avanir Pharmaceuticals: Patrice Saxon, Investor Relations 858-622-5202 psaxon@avanir.com AVANIR PHARMACEUTICALS REPORTS FIRST QUARTER OF FISCAL YEAR 2004 RESULTS San Diego, February 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 bioavailability; 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, -more- 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, 2003 DECEMBER 31, 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. ANNUAL MEETING 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. -more- CONFERENCE CALL AND WEBCAST Management will host a conference call with a simultaneous webcast today at 10:00 a.m. Pacific/ 1:00 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. THE COMPANY 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. - tables to follow - 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, 2003 SEPTEMBER 30, 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

-----END PRIVACY-ENHANCED MESSAGE-----

EX-99.1

                                                                    EXHIBIT 99.1

                                  [AVANIR LOGO]

                                  NEWS RELEASE

FOR IMMEDIATE RELEASE

                  Contact:   At Avanir Pharmaceuticals:
                             Patrice Saxon, Investor Relations
                             858-622-5202
                             psaxon@avanir.com

                         AVANIR PHARMACEUTICALS REPORTS
                    FIRST QUARTER OF FISCAL YEAR 2004 RESULTS

      San Diego, February 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
                  bioavailability; 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,


                                     -more-

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, 2003                 DECEMBER 31, 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.

ANNUAL MEETING

      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.

                                     -more-

CONFERENCE CALL AND WEBCAST

      Management will host a conference call with a simultaneous webcast today
at 10:00 a.m. Pacific/ 1:00 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.

THE COMPANY

      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.

                              - tables to follow -

                             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, 2003     SEPTEMBER 30, 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