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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION SEC File Number
WASHINGTON, DC 20549
FORM 12B-25
CUSIP Number
NOTIFICATION OF LATE FILING
(Check One): /X/ Form 10-K / / Form 20-F / / Form 11-K / / Form 10-Q
/ / Form N-SAR
For Period Ended: September 30, 1998
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/ / Transition Report on Form 10-K / / Transition Report on Form 10-Q
/ / Transition Report on Form 20-F / / Transition Report on Form N-SAR
/ / Transition Report on Form 11-K
For the Transition Period Ended:________________________________________________
READ INSTRUCTION (ON BACK PAGE) BEFORE PREPARING FORM. PLEASE PRINT OR TYPE.
Nothing in this form shall be construed to imply that the Commission has
verified any information contained herein.
If the notification relates to a portion of the filing checked above,
identify the item(s) to which the notification relates: ________________________
________________________________________________________________________________
PART I. REGISTRANT INFORMATION
Full name of registrant Avanir Pharmaceuticals
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Former name if applicable
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Address of principal executive office (Street and number)
9393 Towne Centre Drive, Suite 200
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City, State and Zip Code San Diego, California 92121
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PART II. RULE 12B-25(b) AND (c)
If the subject report could not be filed without unreasonable effort or
expense and the registrant seeks relief pursuant to Rule 12b-25(b), the
following should be completed. (Check where appropriate.)
| (a) The reasons described in reasonable detail in Part III of this form
| could not be eliminated without reasonable effort or expense;
|
| (b) The subject annual report, semi-annual report, transition report on
| Form 10-K, Form 20-F, 11-K or Form N-SAR, or portion thereof will be
/X/ | filed on or before the fifteenth calendar day following the prescribed
| due date; or the subject quarterly report or transition report on Form
| 10-Q, or portion thereof will be filed on or before the fifth calendar
| day following the prescribed due date; and
|
| (c) The accountant's statement or other exhibit required by Rule
| 12b-25(c) has been attached if applicable.
PART III. NARRATIVE
State below in reasonable detail the reasons why Form 10-K, 20-F, 11-K,
10-Q, N-SAR or the transition report or portion thereof, could not be filed
within the prescribed time period.
Filing of subject Form 10-K could not be accomplished by filing date
without unreasonable effort or expense because the Company received notice on
December 22, 1998 from the U.S. Food and Drug Administration that its New Drug
Application for its first commercial product was "non-approvable", requiring
revision of the Company's filing.
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PART IV. OTHER INFORMATION
(1) Name and telephone number of person to contact in regard to this
notification
John J. Hentrich, Esq.
Baker & McKenzie
101 West Broadway, Twelfth Floor
San Diego, California 92101
(619) 236-1441
(2) Have all other periodic reports required under Section 13 or 15(d)
of the Securities Exchange Act of 1934 or Section 30 of the Investment Company
Act of 1940 during the preceding 12 months or for such shorter period that the
registrant was required to file such report(s) been filed? If the answer is
no, identify report(s).
/X/ Yes / / No
(3) Is it anticipated that any significant change in results of
operations from the corresponding period for the last fiscal year will be
reflected by the earnings statements to be included in the subject report or
portion thereof?
/X/ Yes / / No
See the attached exhibit 1 for an explanation of the change in the results
of operations.
Lidak Pharmaceuticals
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(Name of Registrant as Specified in charter)
has caused this notification to be signed on its behalf by the undersigned
thereunto duly authorized.
Date December 29, 1998 By: /s/ Gregory P. Hanson
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Vice President, Finance and
Chief Financial Officer
INSTRUCTION: The form may be signed by an executive officer of the registrant
or by any other duly authorized representative. The name and title of the
person signing the form shall be typed or printed beneath the signature. If the
statement is signed on behalf of the registrant by an authorized representative
(other than an executive officer), evidence of the representative's authority
to sign on behalf of the registrant shall be filed with the form.
ATTENTION
INTENTIONAL MISSTATEMENTS OR OMISSIONS OF FACT CONSTITUTE FEDERAL CRIMINAL
VIOLATIONS (SEC 18 U.S.C. 1001).
GENERAL INSTRUCTIONS
1. This form is required by Rule 12b-25 (17 CFR 240, 12b-25) of the General
Rules and Regulations under the Securities Exchange Act of 1934.
2. One signed original and four conformed copies of this form and amendments
thereto must be completed and filed with the Securities and Exchange
Commission, Washington D.C. 20549, in accordance with Rule 0-3 of the
General Rules and Regulations under the Act. The information contained in or
filed with the form will be made a matter of public record in the Commission
files.
3. A manually signed copy of the form and amendments thereto shall be filed
with each national securities exchange on which any class of securities of
the registrant is registered.
4. Amendments to the notifications must also be filed on form 12b-25 but need
not restate information that has been correctly furnished. The form shall
be clearly identified as an amended notification.
5. Electronic Filers. This form shall not be used by electronic filers unable
to timely file a report solely due to electronic difficulties. Filers unable
to submit a report within the time period prescribed due to difficulties in
electronic filing should comply with either Rule 201 or Rule 202 of
Regulation S-T (sec 232.201 or sec 232.202 of this chapter) or apply for an
adjustment in filing date pursuant to Rule 13(b) of Regulation S-T (sec
232.13(b) of this chapter).
2
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EXHIBIT 1
SELECTED FINANCIAL DATA
The selected financial data presented below at September 30, 1997 and 1998,
for the years ended September 30, 1996, 1997, and 1998 and the period from
August 31, 1988 (inception) through September 30, 1998 are derived from, and are
qualified by reference to, the audited financial statements of the Company
included elsewhere herein and should be read in conjunction with those financial
statements and notes thereto and with "Management's Discussion and Analysis of
Financial Condition and Results of Operations." The selected financial data
presented below at September 30, 1994, 1995 and 1996, and for the years ended
September 30, 1994 and 1995, are derived from audited financial statements not
included herein.
<TABLE>
<CAPTION>
FROM
YEARS ENDED SEPTEMBER 30, AUGUST 31, 1988
--------------------------------------------------------------------- (INCEPTION) TO
1994 1995 1996 1997 1998 SEPTEMBER 30, 1998
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<S> <C> <C> <C> <C> <C> <C>
STATEMENT OF OPERATIONS
DATA
Revenues............. $ 1,016,719 $ 884,589 $ 4,158,038 $ 1,547,554 $ 590,728 $10,139,298
Net loss............. (4,813,341) (10,173,001) (6,130,241) (11,109,242) (8,210,548) (53,615,988)
Net loss per share
(1)................ $ (0.19) $ (0.35) $ (0.19) $ (0.30) $ (0.21)
Weighted average
number of common
shares outstanding
(1)................ 25,166,958 29,338,418 32,072,944 36,779,774 39,519,609
BALANCE SHEET DATA:
Cash, cash
equivalents and
Short-term
investments........ $17,402,896 $ 10,035,727 $20,374,010 $ 14,428,834 6,508,341
Working capital...... 16,837,299 8,567,966 13,759,577 11,336,627 4,819,830
Total assets......... 18,244,299 10,954,043 22,846,879 15,727,495 7,653,800
Convertible notes
payable............ 5,721,087 2,415,461 1,000,000
Total liabilities.... 847,904 1,705,443 7,778,760 3,433,569 2,064,485
Stockholders'
equity............. 17,396,395 9,248,600 15,068,119 12,293,926 5,589,315
</TABLE>
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(1) The Escrow Shares outstanding in the fiscal year ended 1994 are excluded
from the computation of net loss per share.
COMPARISON OF FISCAL 1998 AND 1997
Net Losses -- 1998 vs. 1997
During the fiscal year ended September 30, 1998, ("fiscal 1998") the
Company incurred a net loss of $8.2 million compared to a net loss of $11.1
million in the fiscal year ended September 30, 1997 ("fiscal 1997"). Factors
contributing to the lower loss in fiscal 1998 compared with fiscal 1997 are
discussed below.
Revenues -- 1998 vs. 1997
Revenues totaled $591,000 for fiscal 1998 compared to $1.5 million for
fiscal 1997. Revenues for fiscal 1998 consisted of interest and other income.
The decrease in revenues during fiscal 1998 compared to fiscal 1997 was
attributable to license fees and federal research grant revenue earned in the
1997 period, and lower interest income as a result of a lower average cash
balance during the 1998 period.
Expenses -- 1998 vs. 1997
Research and development expenses ("R&D") decreased by $4.4 million to $3.2
million during fiscal 1998 as compared to fiscal 1997. The decrease in R&D
expenses during fiscal 1998 was primarily attributable to the completion of U.S.
Phase 3 clinical trials in the 1997 period totaling $7.6 million. The Company's
research and development expense during fiscal 1998 consisted of costs of
preparation and filing the Company's NDA for docosanol cream in the first fiscal
quarter of 1998 and costs related to the Company's other research and
development activities. See "Business -- Research and Development."
General and administrative expenses increased by $1.0 million to $4.0
million during fiscal 1998 from $3.0 million during fiscal 1997. The increase in
expenses during fiscal 1998 is due primarily to higher legal expenses related to
the following: (i) evaluation of January 1998 financing proposal presented by
HealthMed, (ii) settlement with Medical Biology Institute as discussed below,
and (iii) matters of litigation and potential litigation between the Company and
Dr. David H. Katz, the Company's former president and chief executive officer
(see "Business -- Legal Proceedings" and Note 6 to the Financial Statements).
Also contributing to the increased expenses during fiscal 1998 were increased
costs of legal and other expenses incurred in connection with the preparation
and distribution of the proxy information to the Company's shareholders related
to the Annual Meetings held in June 1998, increased investor relations
activities due to engaging outside public and investor relations firms and
increased fees and travel for the Company's board of directors due to an
expanded board of directors and a higher number of meetings held during the
fiscal year.
Partially offsetting the overall increased general and administrative
expenses for fiscal 1998 were lower expenses associated with license fees that
were paid in fiscal 1997 due to the Company reacquiring the marketing rights to
docosanol cream from Bristol-Myers Squibb Company. See "Comparison of 1997 and
1996".
Sales and marketing expenses incurred in the amount of $671,000 are due
primarily to the Company's preparation of its product launch of docosanol cream
anticipated to be in early 1999.
Litigation settlement costs totaling $784,000 relate primarily to costs of
the settlement agreement with Medical Biology Institute. See
"Business -- Settlement Agreement with MBI" and Note 5 to the Financial
Statements.
Interest Expense decreased by $2.0 million to $95,000 during fiscal 1998.
This decrease was due to lower interest expense associated with the decrease in
convertible debt outstanding in the period.
