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AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON MARCH 17, 2000
REGISTRATION STATEMENT NO. 333-
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
AVANIR PHARMACEUTICALS
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
CALIFORNIA
(STATE OR OTHER JURISDICTION OF INCORPORATION OR ORGANIZATION)
33-0314804
(I.R.S. EMPLOYER IDENTIFICATION NUMBER)
9393 TOWNE CENTRE DRIVE, SUITE 200
SAN DIEGO, CALIFORNIA 92121
(858) 558-0364
(ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING AREA CODE, OF
REGISTRANT'S PRINCIPAL EXECUTIVE OFFICES)
GERALD J. YAKATAN, PH.D.
PRESIDENT AND CHIEF EXECUTIVE OFFICER
AVANIR PHARMACEUTICALS
9393 TOWNE CENTRE DRIVE, SUITE 200
SAN DIEGO, CALIFORNIA 92121
(858) 558-0364
(NAME, ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING AREA CODE,
OF AGENT FOR SERVICE)
COPIES TO:
CARLOS D. HEREDIA, ESQ.
BAKER & MCKENZIE
101 WEST BROADWAY, SUITE 1200
SAN DIEGO, CA 92101
(619) 236-1441
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
As soon as practicable after this Registration Statement becomes effective.
If the only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box: [ ]
If any of the securities being registered on this Form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connection with dividend or interest
reinvestment plans, check the following box: [ ]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [ ]
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [ ]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [ ]
CALCULATION OF REGISTRATION FEE
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PROPOSED MAXIMUM PROPOSED MAXIMUM
TITLE OF EACH CLASS OF SECURITIES TO BE AMOUNT TO BE OFFERING PRICE AGGREGATE AMOUNT OF
REGISTERED REGISTERED(1) PER UNIT(2) OFFERING PRICE REGISTRATION FEE
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Class A Common Stock, no par value per
share................................. 5,523,288 $3.41 $18,834,412 $4,972
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(1) Represents the following shares of Class A common stock: (i) 5,260,274
shares issued or issuable to Bayview LLC, Roseworth Group, Ltd. and
Endeavour Capital Fund, S.A.; and (ii) 263,014 shares issuable upon the
exercise of Class N stock purchase warrants issued by the Registrant.
Pursuant to Rule 416, the Registrant also registers such additional shares
as may become issuable pursuant to the anti-dilution provisions of the Class
N stock purchase warrants.
(2) Estimated solely for the purpose of calculating the registration fee
pursuant to Rule 457(c) of the Securities Act of 1933. Pursuant to Rule
457(c), the maximum offering price per share is $3.41, the average of the
bid and asked prices of a share of the Registrant's Class A common stock as
reported on the OTC Bulletin Board on March 14, 2000, and the maximum
aggregate offering price of $18,834,412 is the product of $3.41 and the
5,523,288 shares of the Registrant's Class A common stock being registered
hereby.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT WILL
FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION
STATEMENT WILL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF
THE SECURITIES ACT OF 1933, OR UNTIL THE REGISTRATION STATEMENT WILL BECOME
EFFECTIVE ON SUCH DATE AS THE SEC, ACTING PURSUANT TO SAID SECTION 8(a), MAY
DETERMINE.
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INFORMATION CONTAINED HEREIN IS SUBJECT TO COMPLETION OR AMENDMENT. A
REGISTRATION STATEMENT RELATING TO THESE SECURITIES HAS BEEN FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION. THESE SECURITIES MAY NOT BE SOLD
NOR MAY OFFERS TO BUY BE ACCEPTED PRIOR TO THE TIME THE REGISTRATION
STATEMENT BECOMES EFFECTIVE. THIS PROSPECTUS SHALL NOT CONSTITUTE AN
OFFER TO SELL OR THE SOLICITATION OF AN OFFER TO BUY NOR SHALL THERE BE
ANY SALE OF THESE SECURITIES IN ANY STATE IN WHICH SUCH OFFER,
SOLICITATION OR SALE WOULD BE UNLAWFUL PRIOR TO REGISTRATION OR
QUALIFICATION UNDER THE SECURITIES LAWS OF ANY SUCH STATE.
SUBJECT TO COMPLETION, DATED MARCH 17, 2000
PROSPECTUS
5,523,288 shares
AVANIR PHARMACEUTICALS
Class A Common Stock, no par value
-------------------------
We are registering for resale 5,523,288 shares of our Class A common stock,
no par value per share, on behalf of the selling shareholders listed on page 12.
We will not receive any proceeds from the selling shareholders' sale of
their shares of Class A common stock. Any net proceeds that we receive upon
exercise of the stock purchase warrants by the selling shareholders will be
added to working capital.
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Our Class A common stock trades on the OTC Bulletin Board under the trading
symbol "AVNR". On March 14, 2000, the closing bid price of our Class A common
stock was $3.41 and the closing asked price of our Class A common stock was
$3.41.
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INVESTING IN OUR CLASS A COMMON STOCK INVOLVES SEVERAL RISKS.
SEE "RISK FACTORS" BEGINNING ON PAGE 4.
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Neither the SEC nor any state securities commission has approved or
disapproved of these securities or determined if this document is truthful or
complete. Any representation to the contrary is a criminal offense.
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This prospectus is dated March , 2000.
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AVANIR PHARMACEUTICALS
TABLE OF CONTENTS
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PAGE
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Summary..................................................... 1
The Company................................................. 1
Forward-Looking Statements.................................. 3
Risk Factors................................................ 4
Description of Securities................................... 10
Use of Proceeds............................................. 11
Selling Shareholders........................................ 12
Plan of Distribution........................................ 13
Legal Matters............................................... 14
Experts..................................................... 14
Available Information....................................... 15
Incorporation of Certain Information by Reference........... 15
</TABLE>
You should rely only on the information contained or incorporated by
reference in this prospectus and in any prospectus supplement. No one has been
authorized to provide you with different information.
The shares of our Class A common stock are not being offered in any
jurisdiction where the offer is not permitted.
You should not assume that the information in this prospectus or any
prospectus supplement is accurate as of any date other than the date provided on
the front page of the documents.
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SUMMARY
On behalf of our selling shareholders, we are registering for resale
5,523,288 shares of our Class A common stock, which consists of:
- 3,945,206 shares of Class A common stock that we issued or are issuable
to Bayview LLC, in connection with the $6 million financing that we
completed with Bayview LLC, Roseworth Group, Ltd. and Endeavour Capital
Fund, S.A. on January 31, 2000;
- 657,534 shares of Class A common stock that we issued or are issuable to
Roseworth Group LLC, in connection with the $6 million financing;
- 657,534 shares of Class A common stock that we issued or are issuable to
Endeavour Capital Fund, S.A., in connection with the $6 million
financing;
- 197,260 shares of Class A common stock that are issuable upon the
exercise of a Class N stock purchase warrant that we issued to Bayview
LLC, in connection with the $6 million financing;
- 32,877 shares of Class A common stock that are issuable upon the exercise
of a Class N stock purchase warrant that we issued to Roseworth Group,
Ltd., Inc., in connection with the $6 million financing; and
- 32,877 shares of Class A common stock that are issuable upon the exercise
of a Class N stock purchase warrant that we issued to Endeavour Capital
Fund, S.A., in connection with the $6 million financing.
You should read the following information about our company, together with
the more detailed information about the securities underlying this offering,
contained elsewhere in this prospectus. In particular, you should read the
section entitled "Risk Factors," which explains that your investment in shares
of our Class A common stock involves a high degree of risk. Our financial
statements and related notes are not included in this prospectus, but are
incorporated by reference in the exhibits located at the end of this prospectus.
THE COMPANY
We are a development stage company organized to discover, develop and
market novel therapeutic products to treat human diseases. Since our inception
in 1988, we have operated in one business segment -- pharmaceutical product
development.
Docosanol 10% Cream Docosanol 10% cream, a topical treatment for
oral-facial herpes or more commonly known as cold sores or fever blisters, is
our lead therapeutic product that we have been developing for over eight years.
In November 1999, the U.S. Food and Drug Administration informed us that our
clinical data for docosanol 10% cream would be sufficient for approval as an
over-the-counter product, provided that the FDA finds no serious discrepancies
from a site audit conducted at one of our clinical study sites in The
Netherlands. We currently are waiting for the FDA's assessment of this site
audit. We also have submitted proposed OTC product labeling for docosanol 10%
cream, which also is being evaluated by the FDA. If our new drug application is
approved by the FDA, then docosanol 10% cream will be the first OTC product for
cold sore treatment that will have an FDA-approved new drug application to
support claims made about the product's performance.
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On December 20, 1999, we signed a letter of intent with SmithKline Beecham
(NYSE: SBH) for rights to market docosanol 10% cream in the North American OTC
market as a treatment for recurrent oral-facial herpes. At this time, we can
provide no assurance that we will:
- Establish a license agreement with SmithKline Beecham or any major
pharmaceutical company on favorable terms;
- Obtain a successful site audit, as required by the FDA; or
- Agree with the FDA in a timely manner on labeling of the product.
Furthermore, we can give no assurance that the proceeds from a marketing
partnership will be sufficient to continue our other drug discovery and
development programs currently underway.
Other Proposed Products We also are engaged in much earlier stages of
research and/or development of several other potential therapeutic products,
including potential new drugs for the treatment of allergies, asthma and
inflammatory diseases. These additional products will not be available for sale
to the market for several years, if at all.
Our address is 9393 Towne Centre Drive, Suite 200, San Diego, California
92121, and our telephone number is (858) 558-0364. Our e-mail address is
[email protected], and our home page address is http://www.avanir.com.
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FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements concerning future
events or performance of our company. You should not rely excessively on these
forward-looking statements, because they are only predictions based on our
current expectations and assumptions. Forward-looking statements often contain
words like "estimate," "anticipate," "believe" or "expect." Many known and
unknown risks and uncertainties could cause our actual results to differ
materially from those indicated in these forward-looking statements. You should
review carefully the risks and uncertainties identified in this prospectus,
including those explained below and in our other SEC filings such as our Form
10-K for the fiscal year ended September 30, 1999. We have no obligation to
update or announce revisions to any forward-looking statements to reflect actual
events or developments.
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RISK FACTORS
WE ARE A DEVELOPMENT STAGE COMPANY WITH A HISTORY OF CONTINUING LOSSES AND A
LIMITED AMOUNT OF CAPITAL RESERVES.
In the Independent Auditors' Report on our financial statements for the
fiscal year ended September 30, 1999, our auditors indicated that we would need
to raise additional capital to continue as a going concern. From our inception
through September 30, 1999, we have generated only limited revenues and have
incurred net losses totaling approximately $62.1 million. Further, we expect to
continue to incur operating losses related to research and development and
marketing activities, unless we obtain approval from the FDA of our new drug
application for docosanol 10% cream and we enter into a license agreement with
SmithKline Beecham. Docosanol 10% cream still requires regulatory approval
before it can be sold in the marketplace. Even if the FDA approves our new drug
application and we enter into a licensing agreement with SmithKline Beecham for
docosanol 10% cream, we cannot assure you that these events will occur in a
timely manner. If we incur any significant delays, then we would have to defer
our development programs or raise additional financing earlier than we currently
contemplate. We also will likely need to raise additional financing to support
research and development efforts that we believe are necessary to develop other
new drugs.
OUR ABILITY TO MARKET AND SELL DOCOSANOL 10% CREAM IS UNCERTAIN BECAUSE WE HAVE
NOT REACHED A FINAL AGREEMENT WITH SMITHKLINE BEECHAM OR ANY OTHER
PHARMACEUTICAL COMPANY TO MARKET AND SELL THE PRODUCT IN THE OTC MARKET.
We do not have and do not expect to have in the foreseeable future the
resources to manufacture or market directly on a large commercial scale
docosanol 10% cream or any other proposed products that we may develop. We have
entered into collaborative arrangements with manufacturing and distribution
companies in our efforts to commercialize docosanol 10% cream. These
collaborative arrangements likely will cause higher costs or the sharing of
profits with third parties. A potential marketing partner may choose not to use
any of our negotiated agreements. Due to the uncertain nature of the market's
acceptance of docosanol 10% cream as a topical treatment for oral-facial herpes,
we cannot assure you that any license fees and royalties from licensing
docosanol 10% cream will attain a level of revenue sufficient to sustain our
operations.
The timing of the product launch for docosanol 10% cream could be delayed
if our discussions and negotiations with SmithKline Beecham are delayed or
extended. For example, decisions involving the licensing of a pharmaceutical
product likely will involve a substantial amount of due diligence on the part of
both us and SmithKline Beecham. In addition, our ability to negotiate terms of
the amount of advertising and promotion expense by SmithKline Beecham may be
limited. We cannot provide any assurance that, if a license agreement is
negotiated, we and SmithKline Beecham will develop effective advertising or that
consumers will select our product.
We have entered into several licensing agreements to cover the clinical
development, manufacturing and marketing of docosanol 10% cream in foreign
markets. We might not finalize any licensing or distributorship arrangements for
territories not covered by existing agreements on favorable terms, if at all. We
ultimately may establish our own manufacturing and/or marketing capabilities, at
least for specific proposed products, which likely would require substantial
additional funds and personnel.
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OUR AMENDED NEW DRUG APPLICATION FOR DOCOSANOL 10% CREAM MAY NOT RECEIVE FDA
APPROVAL.
We cannot assure you that the FDA will approve docosanol 10% cream as an
OTC product or that the FDA will approve our proposed OTC labeling. Failure to
receive FDA marketing approval could affect materially and adversely our
business operations and financial condition.
On October 29, 1999, the Center for Drug Evaluation and Research informed
us that the clinical data on the effectiveness of docosanol 10% cream in
treating recurrent oral-facial herpes would be sufficient for approval as an OTC
product, pending an acceptable audit of the data in one of the clinical studies
presented in our new drug application. The FDA asked that we submit proposed
product labeling for docosanol 10% cream as an OTC product, which we have
completed. We are currently awaiting FDA assessment of the site audit and
evaluation of our proposed product labeling.
NEITHER WE NOR OUR LICENSEES MAY SUCCESSFULLY SELL DOCOSANOL 10% CREAM AS AN OTC
PRODUCT.
If we and/or our licensees pursue commercialization of docosanol 10% cream
as an OTC product for cold sores/fever blisters, then we will face the following
risks in our efforts to market this product:
- potential delays in achieving timely compliance with FDA regulations for
marketing an OTC product;
- development in a timely manner of a professional marketing staff and
sales communications program to launch the product;
- difficulty in building product awareness of a new OTC product among
customers or retail store decision makers;
- lack of consumer perception that docosanol 10% cream is superior to
existing and potentially new OTC products for oral herpes; and
- lack of widespread acceptance of docosanol 10% cream in the OTC consumer
market.
DOCOSANOL 10% CREAM, IF ULTIMATELY MARKETED, WILL FACE INTENSE COMPETITION FROM
A NUMBER OF EXISTING AND WELL-ESTABLISHED PRODUCTS.
If successfully launched, by us or a marketing partner, then docosanol 10%
cream will compete with several prescription products for oral-facial herpes
currently on the market in the U.S., as well as other products or potential
products that are or may be under development or undergoing the FDA regulatory
approval process. Most of our competitors, including Glaxo-Wellcome Inc., have
greater financial resources, research and development facilities and
manufacturing and marketing experience than we do. Docosanol 10% cream may not
achieve commercial success in this intense competitive environment, which would
severely impact our revenues.
FOREIGN SALES OF DOCOSANOL 10% CREAM AND OTHER POTENTIAL PRODUCTS ARE SUBJECT TO
VARIOUS FOREIGN TRADE RISKS.
We are exposed to various foreign trade risks relating to the continued
development of docosanol 10% cream by foreign licensees. We also may arrange for
contracts in the future for the manufacture, marketing and distribution of
docosanol 10% cream overseas by foreign licensees, which will be
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substantially out of our control. Specific risks that could impact significantly
our ability to deliver products abroad include:
- changes in the regulatory and competitive environments in foreign
countries;
- changes in a specific country's or region's political or economic
conditions;
- difficulty in finding foreign partners with sufficient capital to
effectively launch the product;
- shipping delays;
- difficulties in managing operations across disparate geographic areas;
- fluctuations in foreign currency exchange rates;
- difficulties associated with enforcing agreements through foreign legal
systems; and
- trade protection measures such as customs duties and export quotas.
OUR FAILURE TO COMPLY WITH GOVERNMENT REGULATIONS REGARDING THE DEVELOPMENT,
PRODUCTION, TESTING, MANUFACTURING AND MARKETING OF DOCOSANOL 10% CREAM AND OUR
OTHER PRODUCTS MAY AFFECT ADVERSELY OUR OPERATIONS.
Governmental authorities in the U.S., including the FDA, and other
countries regulate significantly the development, production, testing,
manufacturing and marketing of pharmaceutical products. The clinical testing and
regulatory approval process can take a number of years and require the
expenditure of substantial resources. Although we have completed the development
of docosanol 10% cream and are waiting for the FDA's approval, we may not obtain
regulatory approval for it or any of our other proposed products.
Failure to obtain, or delays in obtaining, these approvals will affect
adversely our business operations, including our ability to commence marketing
of any proposed products. We expect to use a significant portion of our
financial resources for research and development and the clinical trials
necessary to obtain these approvals for our proposed products. We will continue
to incur costs of development without any assurance that we will ever obtain
regulatory approvals. In addition, we cannot predict the extent to which adverse
governmental regulation might arise from future U.S. or foreign legislative or
administrative action. Moreover, we cannot predict with accuracy the effect of
unspecified, but possible, future changes in the regulatory approval process and
in the domestic health care system for which we develop our products. Future
changes could affect adversely the time frame required for regulatory review,
our financial resources, and the sale prices of our proposed products, if
approved for sale.
UNSUCCESSFUL RESEARCH AND DEVELOPMENT PROGRAMS FOR PROPOSED NEW PRODUCTS COULD
AFFECT NEGATIVELY OUR BUSINESS.
We face substantial risks of failing to complete the development of our
early-stage research and development programs in allergy and asthma and other
areas. The effectiveness of our preclinical allergy and asthma research
performed in vitro or in animal models may not be relevant to the development
of, or indicate the efficacy of, a proposed product for human use. Unsuccessful
clinical trial results for our proposed products could affect materially and
adversely our business operations and financial condition. The development
process for medical products is lengthy and capital intensive. Our drug
development programs are exposed to all of the risks inherent in product
development based on innovative technologies, including unanticipated
development problems and the possible lack of funding that could result in the
abandonment or substantial change in the development of a specific product.
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DIFFICULTIES IN ACQUIRING IN-LICENSED TECHNOLOGIES THAT WE BELIEVE ARE NECESSARY
TO FILL OUR PRODUCT DEVELOPMENT PIPELINE MAY NEGATIVELY AFFECT OUR TOCK PRICE
AND RESTRICT OUR GROWTH.
We will face intense competition for these in-licensed products and
technologies. In addition, we might not locate suitable products and
technologies to fit our strengths or obtain them on acceptable terms, or have
the financial resources to develop products from the in-licensed technology. Our
inability to add these technologies and products to our product development
pipeline will hinder our growth and may affect negatively our business.
Our business strategy is to in-license products and/or technologies at
various stages in the drug development pipeline. To achieve this objective, we
must have the financial resources to acquire and/or in-license new products and
technologies and develop and market the products, once approved. For example, we
signed a letter of intent with IriSys Research and Development, LLC in February
1999 to license world-wide rights to a product intended for use in a condition
associated with neurodegenerative diseases and pain. However, due to limited
financial resources in fiscal year 1999, we deferred negotiations of a final
agreement with IriSys to in-license the product. We can provide no assurance
that we will in-license this or any other product or technology.
OUR FAILURE TO RETAIN KEY MANAGEMENT AND SCIENTIFIC PERSONNEL COULD AFFECT
NEGATIVELY OUR BUSINESS.
Our success depends on the performance of a small core staff of key
management and scientific employees. Given our early stage of development, we
depend substantially on our ability to hire, train, retain and motivate high
quality personnel, especially our scientists and management team. If we were to
lose one or more of our key scientists, then we would lose the history and
knowledge that they have which could substantially delay one or more of our
development programs until adequate replacement personnel could be hired and
trained.
Our future success also depends on our continuing ability to identify,
hire, train and retain highly qualified, technical, sales, marketing and
customer service personnel. The employment and employee retention agreements
with several of our key employees are limited in scope and provide no real
assurance that any of these people will continue their employment with our
company. We do not have "key person" life insurance policies. The industry in
which we compete has a high level of employee mobility and aggressive recruiting
of skilled personnel, which creates intense competition for qualified personnel,
particularly in product research, development, sales and marketing.
OUR PATENTS MAY BE CHALLENGED AND OUR PENDING PATENTS MAY BE DENIED, WHICH WOULD
SERIOUSLY JEOPARDIZE OUR ABILITY TO COMPETE IN THE INTENDED MARKETS FOR OUR
PROPOSED PRODUCTS.
We rely substantially on the protection of our intellectual property, with
19 worldwide docosanol patents and 24 additional docosanol-related patent
applications pending. We also have ten patents issued or pending on other
products and technologies. Because of the competitive nature of the bio-
pharmaceutical industry, we cannot assure you that:
- the claims in the pending patent applications will be allowed or that we
will even be issued patents;
- present and future competitors will not develop similar or superior
technologies independently, duplicate our technologies or design around
the patented aspects of our technologies;
- our proposed technologies will not infringe other patents or rights owned
by others, including licenses which may not be available to us;
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- any issued patents will provide us with significant competitive
advantages; or
- challenges will not be instituted against the validity or enforceability
of any patent that we own or, if instituted, that these challenges will
not be successful.
OUR INABILITY TO OBTAIN OR MAINTAIN PATENT PROTECTIONS FOR OUR PRODUCTS IN
FOREIGN MARKETS MAY AFFECT NEGATIVELY OUR FINANCIAL CONDITION.
The process for the approval of patent applications in foreign countries
may differ significantly from the process in the U.S., which may delay our plans
to market and sell docosanol 10% cream in the international market place.
Approval in one country does not necessarily indicate that approval can be
obtained in other countries. The patent authorities in each country administer
that country's laws and regulations relating to patents independently of the
laws and regulations of any other country and we must seek and obtain the
patents separately. Our inability to obtain or maintain patent protections for
docosanol 10% cream in foreign markets would hamper severely our ability to
generate international sales from our first proposed product.
IF WE DO NOT PROTECT OUR TECHNICAL INNOVATIONS, THEN OUR BUSINESS MAY BE
NEGATIVELY AFFECTED.
We rely substantially on confidentiality agreements to protect our
innovations. We cannot assure you that secrecy obligations will be honored, or
that others will not develop independently similar or superior technology. In
addition, if our consultants, key employees or other third parties apply
technological information independently developed by them or by others to our
projects, then disputes may arise as to the proprietary rights to this
information in which we may not receive a favorable resolution.
DEVELOPING NEW PHARMACEUTICAL PRODUCTS FOR HUMAN USE INVOLVES PRODUCT LIABILITY
RISKS, FOR WHICH WE CURRENTLY HAVE LIMITED INSURANCE COVERAGE.
The testing, marketing and sale of pharmaceutical products involve the risk
of product liability claims by consumers and other third parties. We have
maintained product liability insurance coverage for our clinical trials in the
amount of $2 million per incident and in the aggregate. However, product
liability claims can be high in the pharmaceutical industry and our insurance
may not cover sufficiently all possible liabilities. If a suit against our
business or proposed products is successful, then the lack or insufficiency of
insurance coverage could affect materially and adversely our business and
financial condition. Furthermore, various distributors of pharmaceutical
products require minimum product liability insurance coverage before their
purchase or acceptance of products for distribution. Failure to satisfy these
insurance requirements could impede our ability to achieve broad distribution of
our proposed products.
OUR CLASS A COMMON STOCK WAS DELISTED FROM THE NASDAQ NATIONAL MARKET SYSTEM AND
NOW TRADES ON THE OTC BULLETIN BOARD.
Because our Class A common stock currently trades on the OTC Bulletin
Board, shareholders are exposed to various risks, including:
- the liquidity of our Class A common stock is significantly lower as an
OTC Bulletin Board traded security;
- the OTC Bulletin Board does not provide the same level of service or
information to our shareholders; and
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- various brokers may be restricted in making recommendations to their
clients about our Class A common stock.
We can provide no assurance as to how quickly we can regain compliance with
the Nasdaq or any other market listing requirements, if ever.
WE MAY ISSUE ADDITIONAL SHARES OF OUR CLASS A COMMON STOCK THAT MAY DILUTE THE
VALUE OF OUR CLASS A COMMON STOCK TO CURRENT SHAREHOLDERS AND MAY AFFECT
ADVERSELY THE MARKET PRICE OF OUR CLASS A COMMON STOCK.
If we raise additional capital by issuing equity securities at a price or a
value per share less than the then current price per share of Class A common
stock, then the value of the shares of Class A common stock then outstanding
will be diluted or reduced. For example, we potentially may issue and register
up to 8,137,388 shares of our Class A common stock under a two-year, $13 million
equity line agreement with Promethean Investment Group, L.L.C. that could result
in dilution in your ownership position in the company. Depending on the price
per share of our Class A common stock during the next two years, we may need to
register additional shares for resale to access the full amount of financing
available.
In addition, there will be a dilutive effect on the shares of our Class A
common stock from the conversion or exercise of other outstanding securities. As
of March 14, 2000, the following securities exercisable or convertible into
shares of Class A common stock were outstanding:
- stock options to purchase an aggregate of 7,360,654 shares of Class A
common stock at exercise prices ranging from $0.30 to $6.44 per share;
- Class G stock purchase warrant exercisable into 1,835,783 shares of Class
A common stock at an exercise price of $1.375 per share;
- Class H stock purchase warrant exercisable into 100,000 shares of Class A
common stock at an exercise price of $2.40 per share;
- Class I stock purchase warrant exercisable into 250,000 shares of Class A
common stock at an exercise price of $0.78125 per share;
- Class J stock purchase warrants exercisable into 50,000 shares of Class A
common stock at exercise price of $0.9144 per share;
- Class K stock purchase warrant exercisable into 375,000 shares of Class A
common stock at an exercise price of $1.125 per share;
- Class L stock purchase warrant exercisable into 55,000 shares of Class A
common stock at an exercise price of $1.1875 per share;
- Class M stock purchase warrants exercisable into 467,290 shares of Class
A common stock at an exercise price of $1.284 per share;
- Class N stock purchase warrants exercisable into 263,014 shares of Class
A common stock at an exercise price of $2.44 per share; and
- 456,000 shares of Class B common stock each convertible into one share of
Class A common stock.
Sales in the public market of shares of Class A common stock that underlie
stock options and warrants may affect adversely the prevailing market prices for
shares of Class A common stock. Negative price movements in the shares of Class
A common stock likely would affect adversely our ability to obtain additional
equity capital on favorable terms, if at all.
9
<PAGE> 13
DESCRIPTION OF SECURITIES
CLASS A COMMON STOCK AND N STOCK PURCHASE WARRANTS.
On January 25, 2000, we entered into a common stock purchase agreement for
$6 million in financing with three accredited financial institutions: Bayview
LLC; Roseworth Group, Ltd.; and Endeavour Capital Fund, S.A. On January 31,
2000, we closed this $6 million private placement financing and issued to the
investors an aggregate of 2,630,137 shares of Class A common stock and Class N
stock purchase warrants to purchase an aggregate of 263,014 shares of Class A
common stock at an exercise price of $2.44 per share.
Under the terms of the common stock purchase agreement, each investor has
the opportunity to re-price portions of the initial shares of Class A common
stock that the investor holds if we do not achieve specified milestones in the
trading price of our Class A common stock during certain periods of time after
January 31, 2000, as follows:
- From April 30, 2000 to May 30, 2000, each of the investors may re-price
up to 33% of the investor's initial shares if the price of our Class A
common stock has not maintained an average of at least $2.60 per share
during the period;
- From May 31, 2000 to June 30, 2000, each of the investors may re-price up
to an additional 33% of the investor's initial shares if the price of our
Class A common stock has not maintained an average of at least $2.69 per
share during the period;
- From July 1, 2000 to July 31, 2000, each of the investors may re-price up
to an additional 33% of the investor's initial shares if the price of our
Class A common stock has not maintained an average of at least $2.76 per
share during the period; and
- From August 1, 2000 to January 28, 2001, each of the investors may
re-price up to 50% of the investor's initial shares that were not
previously re-priced, if the price of our Class A common stock has not
maintained an average of at least $2.85 per share.
The above dates will adjust if the SEC declares this registration statement
effective after April 30, 2000. If we do not meet these price milestones and one
or more of the investors elects to re-price a portion of the initial shares held
by that investor, then we may either issue additional shares equal in value to
the shortfall in the share price multiplied by the number of re-priced shares,
or pay cash for the value of the shortfall multiplied by the number of re-priced
shares. If we meet the specified price milestones in the given periods, then the
investors cannot re-price any of the initial shares that they hold.
Under the terms of this $6 million private placement financing, we
initially must register 5,523,288 shares of our Class A common stock on behalf
of the investors, which consists of 2,630,137 shares of our Class A common stock
that we issued to the investors on January 31, 2000, an additional 2,630,137
shares of our Class A common stock that we may issue to the investors under the
re-pricing option described above if the price of our Class A common stock does
not exceed the pricing milestones, and an aggregate of 263,014 shares of our
Class A common stock underlying the Class N stock purchase warrants that became
exercisable on January 31, 2000.
REGISTRATION OF SHARES OF CLASS A COMMON STOCK.
We are registering for resale a total of 5,523,288 shares of our Class A
common stock on behalf of the selling shareholders listed on page 12. We will
prepare and file amendments and supplements
10
<PAGE> 14
to this registration statement as may be necessary in accordance with the rules
and regulations of the Securities Act of 1933, to keep it effective until the
earlier of:
- February 28, 2003;
- the date when each of the selling shareholders may sell the shares
covered by this registration statement under Rule 144; or
- the date when each of the selling shareholders no longer owns any shares
covered by this prospectus or securities exercisable into shares covered
by this prospectus.
We have agreed to pay all reasonable expenses incurred in connection with
this registration statement.
USE OF PROCEEDS
We will not receive any proceeds from the resale of any of the shares
registered under this prospectus. We will receive certain cash consideration if
any of the selling shareholders listed on page 12 exercise their respective
Class N stock purchase warrants. We intend to use any cash proceeds that we
receive from exercise of these Class N stock purchase warrants for working
capital purposes. We will pay all fees, disbursements and out-of-pocket expenses
(other than broker discounts and commissions) in connection with the
registration of the shares of Class A common stock registered under this
prospectus. See "Selling Shareholders" for additional information.
11
<PAGE> 15
SELLING SHAREHOLDERS
The table below lists the selling shareholders and other information
regarding the beneficial ownership of shares of our Class A common stock. Except
as otherwise disclosed in this prospectus, the selling shareholders neither have
nor within the past three years had any position, office or other material
relationship with our company or any of its predecessors or affiliates. Because
the selling shareholders may offer all or a portion of the shares of our Class A
common stock registered by this prospectus, we cannot estimate the number of
shares that will be held by the selling shareholders after any sales.
<TABLE>
<CAPTION>
NUMBER OF SHARES OF
COMMON STOCK NUMBER OF SHARES OF
BENEFICIALLY OWNED NUMBER OF SHARES OF CLASS A COMMON STOCK
AS OF MARCH 14, CLASS A COMMON STOCK BENEFICIALLY OWNED
NAME OF SELLING SHAREHOLDER 2000(1) OFFERED HEREBY(2) AFTER OFFERING(3)
- --------------------------- ------------------- -------------------- --------------------
<S> <C> <C> <C>
Bayview LLC(4)............ 2,169,863 4,142,466 0
Endeavour Capital Fund,
S.A.(5)................. 556,348 690,411 194,704
Roseworth Group, Ltd.(6)... 361,644 690,411 0
--------- --------- -------
Total..................... 3,087,855 5,523,288 194,704
</TABLE>
- -------------------------
(1) Beneficial ownership is determined in accordance with SEC rules and
generally includes voting or investment power with respect to securities.
Shares of our Class A common stock that are issuable upon exercise of
outstanding equity securities, including the Class N stock purchase
warrants, to the extent that these securities currently are exercisable
within 60 days of March 14, 2000, are treated as outstanding for computing
each selling shareholder's percentage ownership of shares of our Class A
common stock.
(2) Includes shares of Class A common stock issuable upon exercise of the
re-pricing options by the selling shareholders under the common stock
purchase agreement.
(3) Assumes that all of the shares of our Class A common stock registered under
this prospectus are resold pursuant to this prospectus and that the selling
shareholders will not hold any other shares of our Class A common stock.
(4) Includes 1,972,603 shares held by Bayview LLC and 197,260 shares issuable
upon exercise of a Class N stock purchase warrant. The actual number of
shares of Class A common stock will depend upon the number of additional
shares acquired by Bayview LLC pursuant to the re-pricing option under the
common stock purchase agreement. See "Description of Securities."
(5) Includes 328,767 shares held by Endeavour Capital Fund, S.A., 32,877 shares
issuable upon exercise of a Class N stock purchase warrant and 194,704
shares issuable upon exercise of a Class M stock purchase warrant. The
actual number of shares of Class A common stock will depend upon the number
of additional shares acquired by Endeavour Capital Fund, S.A. pursuant to
the re-pricing option under the common stock purchase agreement. See
"Description of Securities."
(6) Includes 328,767 shares held by Roseworth Group, Ltd. and 32,877 shares
issuable upon exercise of a Class N stock purchase warrant. The actual
number of shares of Class A common stock will depend upon the number of
additional shares acquired by Roseworth Group, Ltd. pursuant to the
re-pricing option under the common stock purchase agreement. See
"Description of Securities."
12
<PAGE> 16
PLAN OF DISTRIBUTION
The selling shareholders have advised us that they may offer the shares of
Class A common stock registered under this prospectus to purchasers from time to
time:
- in transactions on the Nasdaq National Market, the Nasdaq SmallCap
Market, the American Stock Exchange or the OTC Bulletin Board, depending
on which exchange that our common stock is listed, in negotiated
transactions, or by a combination of these methods;
- at fixed prices that may be changed; at market prices prevailing at the
time of the resale;
- at prices related to such market prices; or
- at negotiated prices.
At the date of this prospectus, the selling shareholders have not entered
into any underwriting arrangements. The selling shareholders may sell the shares
registered under this prospectus to or through:
- ordinary brokers' transactions;
- transactions involving cross or block trades or otherwise on the Nasdaq
National Market, the Nasdaq SmallCap Market, the American Stock Exchange
or the OTC Bulletin Board;
- purchases by brokers, dealers or underwriters who may receive
compensation in the form of discounts or commissions from the selling
shareholders or the purchasers of these shares, for whom the
broker-dealers may act as agent or principal, or both;
- "at the market" to or through market makers or into an existing market
for our Class A common stock;
- in other ways not involving market makers or established trading markets,
including direct sales to purchasers or sales effected by agents;
- through transactions in options, swaps or other derivatives (whether
exchange-listed or otherwise);
- in privately negotiated transactions;
- to cover short sales; or
- any combination of the foregoing.
From time to time, one or more of the selling shareholders may pledge,
hypothecate or grant a security interest in some or all of the shares of Class A
common stock registered under this prospectus owned by them, and the pledgees,
secured parties or persons to whom such shares have been hypothecated shall,
upon foreclosure in the event of default, be deemed to be selling shareholders
under this prospectus. The number of shares of Class A common stock registered
under this prospectus and beneficially owned by those selling shareholders who
so transfer, pledge, donate or assign those shares will decrease as and when
they take such actions. The plan of distribution for shares sold under this
prospectus will otherwise remain unchanged, except that the transferees,
pledgees, donees or other successors will be selling shareholders under this
prospectus. In addition, a selling shareholder may, from time to time, sell
short shares of Class A common stock. In such instances, this prospectus may be
delivered in connection with such short sales and the shares of Class A common
stock offered hereby may be used to cover such short sales.
A selling shareholder may enter into hedging transactions with
broker-dealers and the broker-dealers may engage in short sales of the Class A
common stock in the course of hedging the positions they assume with that
selling shareholder, including, without limitation, in connection with
distributions of the Class A common stock by the broker-dealers. A selling
shareholder also may
13
<PAGE> 17
enter into option or other transactions with broker-dealers that involve the
delivery of the shares of Class A common stock registered under this prospectus
to the broker-dealers, who then may resell or otherwise transfer these shares. A
selling shareholder also may loan or pledge the shares of Class A common stock
registered under this prospectus to a broker-dealer and the broker-dealer may
sell the shares so loaned or upon a default may sell or otherwise transfer the
pledged shares.
Broker, dealers, underwriters or agents participating in the distribution
of the shares of Class A common stock registered under this prospectus as agents
may receive compensation in the form of commissions, discounts or concessions
from the selling shareholders and/or purchasers of the Class A common stock for
whom the broker-dealers may act as agent, or to whom they may sell as principal,
or both (which compensation as to a particular broker-dealer may be less than or
in excess of customary commissions). The selling shareholders and any
broker-dealers who act in connection with the sale of the shares of Class A
common stock under this prospectus may be deemed to be "underwriters" within the
meaning of the Securities Act of 1933, and any commissions they receive and
proceeds of any sale of the shares of Class A common stock may be deemed to be
underwriting discounts and commissions under the Securities Act of 1933. Neither
we nor any of the selling shareholders can presently estimate the amount of this
compensation. We know of no existing arrangements between any of the selling
shareholders, any other shareholder, broker, dealer, underwriter or agent
relating to the sale or distribution of the shares of Class A common stock
registered under this prospectus.
We will pay substantially all of the expenses relating to the registration,
offer and sale of the shares of Class A common stock registered under this
prospectus to the public other than commissions or discounts of underwriters,
broker-dealers or agents. We also have agreed to indemnify the selling
shareholders and certain related persons against any losses, claims, damages or
liabilities under the Securities Act of 1933 or otherwise that arise out of, or
are based upon, any untrue or alleged untrue statement of a material fact or the
omission or alleged omission instating a material fact under this registration
statement or prospectus.
To the extent that indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to our directors, officers and
controlling persons, we have been advised that, in the opinion of the SEC, this
indemnification is against public policy as expressed in the Securities Act of
1933 and is therefore, unenforceable.
LEGAL MATTERS
The validity of the securities offered hereby have been passed upon for our
company by Baker & McKenzie, San Diego, California.
EXPERTS
The financial statements incorporated in this prospectus by reference from
our Annual Report on Form 10-K for the year ended September 30, 1999 have been
audited by Deloitte & Touche LLP, independent auditors, as stated in their
report, which is incorporated herein by reference (which report expresses an
unqualified opinion and includes explanatory paragraphs relating to our status
as a development stage enterprise, our ability to continue as a going concern,
and our status as a defendant in certain lawsuits), and have been so
incorporated in reliance upon the report of such firm given upon their authority
as experts in accounting and auditing.
14
<PAGE> 18
AVAILABLE INFORMATION
We are required to follow the reporting requirements of the Securities
Exchange Act of 1934. To comply with these requirements, we file a number of
reports, including annual and quarterly reports, proxy statements, information
statements and other information with the SEC. You may inspect and copy any of
this information that we have filed with the SEC at the public reference
facilities maintained by the SEC at 450 Fifth Street, N.W., Room 1024,
Washington, D.C. 20549, and at the SEC's regional offices located at 7 World
Trade Center, Suite 1300, New York, New York 10048 and Citicorp Center, 500 W.
Madison Street, Suite 1400, Chicago, IL 60661-2511. You may obtain information
on the operation of the public reference room by calling the Commission at
1-800-SEC-0330. You also may obtain copies of such material at prescribed rates
from the Public Reference Section of the SEC at Judiciary Plaza, 450 Fifth
Street, N.W., Washington, D.C. 20549. If our Class A common stock becomes listed
on one of the national market exchanges, then you also may inspect such reports,
proxy statements, information statements and other information concerning us at
the offices of such national market exchange. If our Class A common stock
becomes listed on the Nasdaq National Market System or the OTC Bulletin Board,
then our information may be obtained from The Nasdaq Stock Market, Inc. at 1735
K Street, N.W., Washington, D.C. 20006; or if our Class A common stock becomes
listed on the American Stock Exchange, then our information may be obtained from
The American Stock Exchange, 86 Trinity Place, New York, NY 10004. You also may
access the materials that we file electronically with the SEC at the SEC's
website (http://www.sec.gov), which contains the reports, proxy statements,
information statements and other information that we file electronically with
the SEC.
We have filed with the SEC a Registration Statement on Form S-3 under the
Securities Act of 1933, with respect to the shares covered by this prospectus.
This prospectus does not contain all of the information set forth in the
registration statement, because certain parts are omitted in accordance with the
rules and regulations of the SEC. Statements made in this prospectus as to the
contents of any contract, agreement or other document referred to are not
necessarily complete and, with respect to each such contract, agreement or other
document filed as an exhibit to the registration statement, we refer you to such
exhibit for a more complete description of the matter involved. Each such
statement is deemed qualified in its entirety by such reference.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
We incorporate by reference in this prospectus and encourage you to read
the following documents that we have filed with the SEC pursuant to the
requirements of the Securities Exchange Act of 1934:
1. Our Annual Report on Form 10-K for the fiscal year ended September 30,
1999 filed with the SEC on January 13, 2000;
2. Our Definitive Proxy Statement filed with the SEC on January 26, 2000;
3. Our Current Reports on Form 8-K filed with the SEC on October 4, 1999,
December 3, 1999, February 4, 2000 and February 23, 2000;
4. Our Quarterly Report on Form 10-Q for the quarter ended December 31,
1999 filed with the SEC on February 14, 2000; and
5. The description of our Class A common stock contained in our
Registration Statement on Form 8-A filed with the SEC on July 31, 1990,
including any amendments or reports filed for the purpose of updating
the description.
15
<PAGE> 19
We also incorporate by reference as part of this prospectus and encourage
you to read all reports and other documents that we have filed (or will file)
with the SEC under the Securities Exchange Act of 1934, that are after the date
of this prospectus and before the termination of the offering of the shares
registered under this prospectus. You should understand that, if any statement
contained in a report or document that is incorporated by reference in this
prospectus is modified or superseded, then the later filed report or document
will modify or supersede the statements contained in this prospectus.
We will provide without charge to each person, including any beneficial
owner, to whom a copy of this prospectus is delivered, upon the written or oral
request of that person, a copy of any and all documents incorporated by
reference in this prospectus (not including, however, the exhibits to those
documents unless those exhibits are specifically incorporated by reference in
such documents). Requests should be sent to the attention of the Secretary of
our company, at 9393 Towne Centre Drive, Suite 200, San Diego, California 92121
or you may call and ask for the Secretary of our company at (858) 558-0364.
16
<PAGE> 20
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The estimated cumulative expenses of this registration of shares of our
Class A common stock for resale by the selling shareholders, all of which are to
be paid by the registrant in connection with the issuance and distribution of
the shares being registered, are estimated as follows:
<TABLE>
<S> <C>
SEC Registration Fee........................................ $ 4,972
Accounting Fees and Expenses................................ 4,500
Legal Fees and Expenses..................................... 55,000
Blue Sky Fees and Expenses.................................. 1,000
Transfer Agent's Fees and Expenses.......................... 500
Miscellaneous Expenses...................................... 1,000
-------
Total............................................. $66,972
=======
</TABLE>
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
We hereby incorporate by reference Sections 204(a)(10) and (11), 204.5 and
317 of the California General Corporation Law which covers the indemnification
of directors, officers, employees and agents of a corporation. We refer you to
Article 6 of our Restated Articles of Incorporation, and Section 3.15 of our
Amended and Restated Bylaws, which provide for indemnification by our company in
the manner and to the full extent permitted by California law.
Beginning August 10, 1992, we have maintained directors' and officers'
liability insurance with policy limits of $7,500,000. The policy covers 100
percent of losses arising from, among other things, claims of breach of duty,
neglect, error, alleged misstatement, misleading statement or omission by the
directors and officers in their capacity as such. Payment for loss would be made
to or on our behalf where we are required or permitted to indemnify directors or
officers for covered losses pursuant to statutory or common law, our Restated
Articles of Incorporation or Amended and Restated Bylaws or by agreement. The
policy provides for retention of $5,000 per director or officer, subject to a
maximum of $10,000 for each loss, except in the case of payment for loss to or
on our behalf, in which case the retention is $100,000.
ITEM 16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
(A) EXHIBITS
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
- ------- -----------
<C> <S>
1.1 Underwriting Agreement(1)
4.1 Class D Warrant Agreement (including form of Class D Warrant
Certificate)(2)
4.2 Warrant Agreement (including form of Class E Warrant
Certificate)(2)
4.3 Form of Unit Purchase Option issued to D.H. Blair & Co.,
Inc. and its designees regarding Series B Preferred Stock
and Class D Warrants(2)
4.4 Registration Rights Agreement(2)
4.5 Certificate of Determination with respect to Series D
Convertible Preferred Stock of the Registrant(3)
</TABLE>
II-1
<PAGE> 21
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
- ------- -----------
<C> <S>
4.6 Certificate of Determination with respect to Series C Junior
Participating Preferred Stock of the Registrant(3)
4.7 Rights Agreement, dated as of March 5, 1999, with American
Stock Transfer & Trust Company(3)
4.8 Form of Rights Certificate with respect to the Rights
Agreement, dated as of March 5, 1999(3)
4.9 Form of Series D Convertible Preferred Stock Certificate(3)
4.10 Amended and Restated Class I Stock Purchase Warrant, dated
as of March 4, 1999(3)
4.11 Form of Class J Stock Purchase Warrant(3)
4.12 Class K Stock Purchase Warrant, dated as of April 1, 1999(3)
4.13 Registration Rights Agreement with Promethean Investment
Group, LLC(3)
4.14 Class A Common Stock Investment Agreement with Promethean
Investment Group, LLC(3)
4.15 Amendment to the Class A Common Stock Investment Agreement
with Promethean Investment Group, LLC(3)
4.16 Securities Purchase Agreement for Series D Convertible
Preferred Stock(3)
4.17 Registration Rights Agreement for Series D Convertible
Preferred Stock(3)
4.18 Forms of Class A and Class B Common Stock Certificates(4)
4.19 Convertible Note issued to GFL Advantage Fund Limited(5)
4.20 Registration Rights Agreement with GFL Advantage Fund
Limited(5)
4.21 Convertible Note issued to Capital Ventures International(6)
4.22 Registration Rights Agreement with Capital Ventures
International(6)
4.23 Convertible Note, dated February 26, 1997, issued to RGC
International Investors LLC(7)
4.24 Form of Class G Stock Purchase Warrant(7)
4.25 Registration Rights Agreement, dated February 26, 1997, with
RGC International Investors, LLC(7)
4.26 Class L Stock Purchase Warrant, dated as of June 8, 1999(8)
4.27 Loan Agreement, dated as of November 23, 1999, with AMRO
International, S.A. and Endeavour Capital Fund, S.A.(9)
4.28 Form of 11% Convertible Debenture(9)
4.29 Form of Stock Purchase Warrant(9)
4.30 Registration Rights Agreement, dated as of November 23,
1999, with AMRO International, S.A. and Endeavour Capital
Fund, S.A.(9)
4.31 Amendment No. 1 to Rights Agreement, dated as of November
30, 1999, with American Stock Transfer & Trust Company(9)
4.32 Common Stock Purchase Agreement, dated as of January 25,
2000, with Bayview LLC, Roseworth Group Ltd. and Endeavour
Capital Fund, S.A.(10)
</TABLE>
II-2
<PAGE> 22
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
- ------- -----------
<C> <S>
4.33 Registration Rights Agreement, dated as of January 25, 2000,
with Bayview LLC, Roseworth Group Ltd. and Endeavour Capital
Fund, S.A.(10)
4.34 Form of Stock Purchase Warrant(10)
5.1 Opinion of Baker & McKenzie
23.1 Independent Auditors' Consent
</TABLE>
- -------------------------
(1) Incorporated by reference to the similarly described exhibits filed in
connection with the Registrant's Registration Statement on Form S-1, File
No. 33-37166, declared effective by the Securities and Exchange Commission
on November 9, 1990.
(2) Incorporated by reference to the similarly described exhibit included with
the Registrant's Registration Statement on Form S-1, File No. 33-49082,
declared effective by the Commission on October 26, 1992.
(3) Incorporated by reference to the similarly described exhibit included with
the Registrant's Quarterly Report on Form 10-Q for the quarter ended March
31, 1999, filed May 17, 1999.
(4) Incorporated by reference to the similarly described exhibit included with
the Registrant's Registration Statement on Form S-1, File No. 33-32742,
declared effective by the Commission on May 8, 1990.
(5) Incorporated by reference to the similarly described exhibit included with
the Registrant's Annual Report on Form 10-K for the fiscal year ended
September 30, 1995, filed December 15, 1995.
(6) Incorporated by reference to the similarly described exhibit included with
the Registrant's Quarterly Report on Form 10-Q for the quarter ended March
31, 1996, filed May 15, 1996.
(7) Incorporated by reference to the similarly described exhibit included with
the Registrant's Form 8-K, filed March 10, 1997.
(8) Incorporated by reference to the similarly described exhibit included with
the Registrant's Quarterly Report on Form 10-Q for the quarter ended June
30, 1999, filed August 16, 1999.
(9) Incorporated by reference to the similarly described exhibit included with
the Registrant's Form 8-K, filed December 3, 1999.
(10) Incorporated by reference to the similarly described exhibit included with
the Registrant's Form 8-K, filed February 4, 2000.
ITEM 17. UNDERTAKINGS.
We hereby undertake:
1. To file, during any period in which offers or sales are being made,
a post-effective amendment to this registration statement:
i. To include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933;
ii. To reflect in this prospectus any facts or events arising after
the effective date of this registration statement (or the most recent
post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set forth
in this registration statement; and
II-3
<PAGE> 23
iii. To include any material information with respect to the plan
of distribution not previously disclosed in this registration statement
or any material change to such information in this registration
statement.
2. That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment will be deemed
to be a new registration statement relating to the securities registered
therein, and the offering of such securities at that time will be deemed to
be the initial bona fide offering thereof.
3. To remove from registration by means of a post-effective amendment
any of the securities being registered that remain unsold at the
termination of the offering.
Insofar as indemnification for liabilities arising under the Securities Act
of 1933, may be permitted to directors, officers and controlling persons of the
registrant pursuant to the provisions of its Restated Articles of Incorporation
and Amended and Restated By-laws of the registrant, the California General
Corporation Law or otherwise, the registrant has been advised that in the
opinion of the SEC such indemnification is against public policy as expressed in
the Securities Act of 1933, and is therefore unenforceable. If a claim for
indemnification against such liabilities (other than the payment by the issuer
of expenses incurred or paid by a director, officer or controlling person of the
registrant in the successful defense of any action, suit or proceeding) is
asserted by such director, officer or controlling person in connection with the
securities being registered, then the registrant will, unless in the opinion of
its counsel the matter has been settled by controlling precedent, submit to a
court of appropriate jurisdiction the question whether such indemnification by
it is against public policy as expressed in the Securities Act of 1933, and will
be governed by the final adjudication of such issue.
II-4
<PAGE> 24
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant
certifies that it has reasonable grounds to believe it meets all of the
requirements for filing on Form S-3 and has duly caused this registration
statement to be signed on its behalf by the undersigned, there unto duly
authorized, in the City of San Diego, State of California, on March 17, 2000.
AVANIR PHARMACEUTICALS
By: /s/ GERALD J. YAKATAN
------------------------------------
Gerald J. Yakatan, Ph.D.
President and Chief Executive
Officer
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below hereby constitutes and appoints Gerald J. Yakatan, Ph.D. and
Gregory P. Hanson, and each of them acting individually, as his
attorney-in-fact, each with full power of substitution and resubstititution, for
him in any and all capacities, to sign any and all amendments to this
registration statement, and to file the same, with exhibits thereto and other
documents in connection therewith, with the SEC, granting unto said
attorneys-in-fact and agents, each acting alone, full power and authority to do
and perform each and every act and thing requisite and necessary to be done in
and about the premises, as fully for all intents and purposes as he might or
could do in person, hereby ratifying and confirming our signatures as they may
be signed by our said attorneys-in-fact to any and all amendments to this
registration statement.
Pursuant to the requirements of the Securities Act of 1933, this
registration statement has been signed by the following persons in the
capacities indicated on March 17, 2000.
<TABLE>
<CAPTION>
SIGNATURE TITLE
--------- -----
<S> <C>
/s/ GERALD J. YAKATAN President and Chief Executive Officer
- -------------------------------------------------------- (Principal Executive Officer)
Gerald J. Yakatan, Ph.D.
/s/ GREGORY P. HANSON Vice President, Finance and Chief
- -------------------------------------------------------- Financial Officer (Principal Financial and
Gregory P. Hanson Accounting Officer)
/s/ GEORGE P. RUTLAND Chairman of the Board of Directors
- --------------------------------------------------------
George P. Rutland
/s/ DENNIS J. CARLO Director
- --------------------------------------------------------
Dennis J. Carlo, Ph.D.
/s/ MICHAEL W. GEORGE Director
- --------------------------------------------------------
Michael W. George
/s/ JAMES B. GLAVIN Director
- --------------------------------------------------------
James B. Glavin
/s/ EDWARD L. HENNESSY, JR. Director
- --------------------------------------------------------
Edward L. Hennessy, Jr.
</TABLE>
II-5
<PAGE> 25
<TABLE>
<CAPTION>
SIGNATURE TITLE
--------- -----
<S> <C>
/s/ KENNETH E. OLSON Director
- --------------------------------------------------------
Kenneth E. Olson
/s/ JOSEPH E. SMITH Director
- --------------------------------------------------------
Joseph E. Smith
</TABLE>
II-6
<PAGE> 26
INDEX TO EXHIBITS
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
- ------- -----------
<C> <S>
1.1 Underwriting Agreement(1)
4.1 Class D Warrant Agreement (including form of Class D Warrant
Certificate)(2)
4.2 Warrant Agreement (including form of Class E Warrant
Certificate)(2)
4.3 Form of Unit Purchase Option issued to D.H. Blair & Co.,
Inc. and its designees regarding Series B Preferred Stock
and Class D Warrants(2)
4.4 Registration Rights Agreement(2)
4.5 Certificate of Determination with respect to Series D
Convertible Preferred Stock of the Registrant(3)
4.6 Certificate of Determination with respect to Series C Junior
Participating Preferred Stock of the Registrant(3)
4.7 Rights Agreement, dated as of March 5, 1999, with American
Stock Transfer & Trust Company(3)
4.8 Form of Rights Certificate with respect to the Rights
Agreement, dated as of March 5, 1999(3)
4.9 Form of Series D Convertible Preferred Stock Certificate(3)
4.10 Amended and Restated Class I Stock Purchase Warrant, dated
as of March 4, 1999(3)
4.11 Form of Class J Stock Purchase Warrant(3)
4.12 Class K Stock Purchase Warrant, dated as of April 1, 1999(3)
4.13 Registration Rights Agreement with Promethean Investment
Group, LLC(3)
4.14 Class A Common Stock Investment Agreement with Promethean
Investment Group, LLC(3)
4.15 Amendment to the Class A Common Stock Investment Agreement
with Promethean Investment Group, LLC(3)
4.16 Securities Purchase Agreement for Series D Convertible
Preferred Stock(3)
4.17 Registration Rights Agreement for Series D Convertible
Preferred Stock(3)
4.18 Forms of Class A and Class B Common Stock Certificates(4)
4.19 Convertible Note issued to GFL Advantage Fund Limited(5)
4.20 Registration Rights Agreement with GFL Advantage Fund
Limited(5)
4.21 Convertible Note issued to Capital Ventures International(6)
4.22 Registration Rights Agreement with Capital Ventures
International(6)
4.23 Convertible Note, dated February 26, 1997, issued to RGC
International Investors LLC(7)
4.24 Form of Class G Stock Purchase Warrant(7)
4.25 Registration Rights Agreement, dated February 26, 1997, with
RGC International Investors, LLC(7)
4.26 Class L Stock Purchase Warrant, dated as of June 8, 1999(8)
4.27 Loan Agreement, dated as of November 23, 1999, with AMRO
International, S.A. and Endeavour Capital Fund, S.A.(9)
4.28 Form of 11% Convertible Debenture(9)
4.29 Form of Stock Purchase Warrant(9)
4.30 Registration Rights Agreement, dated as of November 23,
1999, with AMRO International, S.A. and Endeavour Capital
Fund, S.A.(9)
4.31 Amendment No. 1 to Rights Agreement, dated November 30,
1999, with American Stock Transfer & Trust Company(9)
4.32 Common Stock Purchase Agreement, dated as of January 25,
2000, with Bayview LLC, Roseworth Group Ltd. and Endeavour
Capital Fund, S.A.(10)
</TABLE>
<PAGE> 27
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
- ------- -----------
<C> <S>
4.33 Registration Rights Agreement, dated as of January 25, 2000,
with Bayview LLC, Roseworth Group Ltd. and Endeavour Capital
Fund, S.A.(10)
4.34 Form of Stock Purchase Warrant(10)
5.1 Opinion of Baker & McKenzie
23.1 Independent Auditors' Consent
</TABLE>
- -------------------------
(1) Incorporated by reference to the similarly described exhibits filed in
connection with the Registrant's Registration Statement on Form S-1, File
No. 33-37166, declared effective by the Securities and Exchange Commission
on November 9, 1990.
(2) Incorporated by reference to the similarly described exhibit included with
the Registrant's Registration Statement on Form S-1, File No. 33-49082,
declared effective by the Commission on October 26, 1992.
(3) Incorporated by reference to the similarly described exhibit included with
the Registrant's Quarterly Report on Form 10-Q for the quarter ended March
31, 1999, filed May 17, 1999.
(4) Incorporated by reference to the similarly described exhibit included with
the Registrant's Registration Statement on Form S-1, File No. 33-32742,
declared effective by the Commission on May 8, 1990.
(5) Incorporated by reference to the similarly described exhibit included with
the Registrant's Annual Report on Form 10-K for the fiscal year ended
September 30, 1995, filed December 15, 1995.
(6) Incorporated by reference to the similarly described exhibit included with
the Registrant's Quarterly Report on Form 10-Q for the quarter ended March
31, 1996, filed May 15, 1996.
(7) Incorporated by reference to the similarly described exhibit included with
the Registrant's Form 8-K, filed March 10, 1997.
(8) Incorporated by reference to the similarly described exhibit included with
the Registrant's Quarterly Report on Form 10-Q for the quarter ended June
30, 1999, filed August 16, 1999.
(9) Incorporated by reference to the similarly described exhibit included with
the Registrant's Form 8-K, filed December 3, 1999.
(10) Incorporated by reference to the similarly described exhibit included with
the Registrant's Form 8-K, filed February 4, 2000.
<PAGE> 1
EXHIBIT 5.1
Opinion of Baker & McKenzie
March 17, 2000
AVANIR Pharmaceuticals
9393 Towne Centre Drive, Suite 200
San Diego, California 92121
Ladies and Gentlemen:
We have acted as counsel to AVANIR Pharmaceuticals, a California
corporation (the "Company"), in connection with its filing with the Securities
and Exchange Commission under the Securities Act of 1933, as amended (the
"Securities Act"), of a Registration Statement on Form S-3, filed with the SEC
on March 17, 2000, including exhibits thereto (the "Registration Statement"),
covering 5,523,288 shares (the "Shares") of the Company's Class A Common Stock,
no par value per share.
We have examined the originals, or photostatic or certified copies, of
such records of the Company, certificates of officers of the Company and of
public officials, and such other documents as we have deemed relevant and
necessary as the basis of the opinion set forth below. In such examination, we
have assumed the genuineness of all signatures, the authenticity of all
documents submitted to us as photostatic or certified copies and the
authenticity of the originals of such copies.
Based upon our examination, we are of the opinion that the Shares have
been validly authorized and are legally issued, fully paid and non-assessable.
We express no opinion as to the applicability of, compliance with, or
effect of federal law or the law of any jurisdiction other than the General
Corporation Law of the State of California.
We hereby consent to the use of our opinion as herein set forth as an
exhibit to the Registration Statement and to the use of our name under the
caption "Legal Matters" in the prospectus forming a part of the Registration
Statement. This consent is not to be construed as an admission that we are a
person whose consent is required to be filed with the Registration Statement
under the provisions of the Securities Act.
Very truly yours,
BAKER & MCKENZIE
<PAGE> 1
EXHIBIT 23.1
INDEPENDENT AUDITORS' CONSENT
AVANIR Pharmaceuticals:
We consent to the incorporation by reference in this Registration Statement of
AVANIR Pharmaceuticals, formerly LIDAK Pharmaceuticals (a development stage
enterprise) (the "Company") on Form S-3, of our report dated December 21, 1999
(which expresses an unqualified opinion and includes explanatory paragraphs
relating to the status of the Company as a development stage enterprise, the
Company's ability to continue as a going concern, and the Company as a defendant
in certain lawsuits), appearing in the Annual Report on Form 10-K of AVANIR
Pharmaceuticals for the year ended September 30, 1999, and to the reference to
us under the heading "Experts" in the Prospectus, which is part of such
Registration Statement.
DELOITTE & TOUCHE LLP
San Diego, California
March 17, 2000
