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AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON AUGUST 26, 1998
REGISTRATION NO. 333-____________
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
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SCICLONE PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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CALIFORNIA 94-3116852
(State or other jurisdiction of (IRS Employer
incorporation or organization) Identification No.)
901 MARINERS ISLAND BOULEVARD, SUITE 205
SAN MATEO, CALIFORNIA 94404
(650) 358-3456
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
-----------------------
DONALD R. SELLERS
PRESIDENT AND CHIEF EXECUTIVE OFFICER
SCICLONE PHARMACEUTICALS, INC.
901 MARINERS ISLAND BOULEVARD, SUITE 205
SAN MATEO, CALIFORNIA 94404
(650) 358-3456
(Name, address, including zip code, and telephone number, including
area code, of agent for service)
Copies to:
J. HOWARD CLOWES, ESQ.
Gray Cary Ware & Freidenrich LLP
139 Townsend Street, Suite 400
San Francisco, California 94107
(415) 836-2500
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: From
time to time as described in the Prospectus after the effective date of this
Registration Statement.
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. [X]
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. [ ]
<TABLE>
<CAPTION>
CALCULATION OF REGISTRATION FEE
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PROPOSED MAXIMUM PROPOSED MAXIMUM AMOUNT OF
Title of Each Class of AMOUNT TO BE OFFERING PRICE AGGREGATE OFFERING REGISTRATION FEE
Securities to be Registered REGISTERED PER SHARE PRICE
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<S> <C> <C> <C> <C>
Common Stock (no par value) 600,000 shares (1) $2.1875 (2) $1,312,500 $387.19
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</TABLE>
(1) Represents the number of shares of Common Stock issued or issuable in
connection with the acquisition of certain rights related to thymosin
alpha 1, as described in the Prospectus.
(2) Estimated solely for the purpose of computing the registration fee
pursuant to Rule 457(c) of the 1933 Act and based on the average of the
high and low sales prices of the Common Stock of SciClone
Pharmaceuticals, Inc. reported on the Nasdaq National Market on August
19, 1998.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES
AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE
A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT
SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE
SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SUCH SECTION 8(a),
MAY DETERMINE.
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THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. WE MAY
NOT SELL THESE SECURITIES UNTIL THE REGISTRATION STATEMENT FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER
TO SELL THESE SECURITIES AND IT IS NOT SOLICITING AN OFFER TO BUY THESE
SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
SUBJECT TO COMPLETION, DATED _______________, 1998
600,000 SHARES
SCICLONE PHARMACEUTICALS, INC.
COMMON STOCK
The 600,000 shares of Common Stock (the "Shares") of SciClone
Pharmaceuticals, Inc., a California corporation ("SciClone" or the "Company"),
offered by this Prospectus consist of 444,115 shares issued and up to 155,885
shares issuable in connection with the acquisition of certain rights related to
thymosin alpha 1.
The Company has entered into an Alpha Rights Acquisition Agreement (the
"Acquisition Agreement") with Alpha 1 Biomedicals, Inc. ("Alpha 1" or the
"Selling Shareholder") whereby the Company acquired Alpha 1's worldwide
marketing, development and manufacturing rights to the Company's lead drug,
thymosin alpha 1. Pursuant to the Acquisition Agreement, the aggregate purchase
price is $1.930 million, consisting of $130,000 in cash and $1.8 million of the
Company's common stock, up to a maximum of 600,000 shares. 444,115 shares were
issued in connection with the closing of the Acquisition Agreement and up to
155,885 shares are issuable in decreasing monthly increments during the 12
months following the effective date of the registration statement. In connection
with the Acquisition Agreement, the Company agreed to use its best efforts to
cause a registration statement with respect to the common stock to be issued to
Alpha 1 to become effective within 120 days of the closing of the transaction.
Alpha 1 agreed to limit the number of shares of the Company's common stock it
will sell each month to 50,000 shares during the 12 months following the
effective date of the registration statement.
The Company will bear all out-of-pocket expenses incurred in connection
with the registration of the Shares, including, without limitation, all
registration and filing fees imposed by the Securities and Exchange Commission
(the "Commission"), the National Association of Securities Dealers, Inc. (the
"NASD") and blue sky laws, printing expenses, transfer agents' and registrars'
fees, and the reasonable fees and disbursements of the Company's outside counsel
and independent accountants, but excluding transfer or other taxes and other
costs and expenses incident to the issuances of the Shares.
The Company's Common Stock is quoted on The Nasdaq National Market
under the symbol "SCLN." On August 25, 1998, the last sale price of the
Company's Common Stock as reported on The Nasdaq National Market was $2.13.
----------------------------------
SEE "RISK FACTORS" BEGINNING ON PAGE 3 FOR INFORMATION THAT SHOULD BE
CONSIDERED BY PROSPECTIVE PURCHASERS OF THE SHARES OFFERED HEREBY.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND
EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE SECURITIES
AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED
UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY
REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
----------------------------------
The date of this Prospectus is ____________, 1998.
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AVAILABLE INFORMATION
The Company is subject to the informational requirements of the
Securities Exchange Act of 1934, as amended (the "Exchange Act"), and in
accordance therewith files reports, proxy statements (if required) and other
information with the Commission. The reports, proxy statements and other
information filed by the Company with the Commission may be inspected and copied
at the public reference facilities maintained by the Commission at Judiciary
Plaza, Room 1024, 450 Fifth Street, N.W., Washington, D.C. 20549, and at the
Regional Offices of the Commission located at Northwestern Atrium Center, 500
West Madison Street, Suite 1400, Chicago, Illinois 60611 and 7 World Trade
Center, Suite 1300, New York, New York 10048. Copies of such material can also
be obtained by mail from the Public Reference Section of the Commission at 450
Fifth Street, N.W., Washington, D.C. 20549. The Company's Common Stock is traded
on The Nasdaq National Market. Reports and other information concerning the
Company can also be inspected at the offices of the National Association of
Securities Dealers, Inc., Market Listing Section, 1735 K Street, N.W.,
Washington, D.C. 20006. Such reports and other information may also be inspected
without charge at a Web site maintained by the Commission. The address of the
site is http://www.sec.gov.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents filed with the Commission by the Company
pursuant to the Exchange Act are incorporated herein by reference:
1. Quarterly Report on Form 10-Q for the period ended June 30,
1998, filed with the Commission on August 14, 1998;
2. Report on Form 8-K filed with the Commission on July 23, 1998;
3. Amended Annual Report on Form 10-K/A for the year ended
December 31, 1997, filed with the Commission on June 8, 1998;
4. Quarterly Report on Form 10-Q for the period ended March 31,
1998, filed with the Commission on May 14, 1998.
5. The definitive Proxy Statement for the Company's 1998 Annual
Meeting of Shareholders filed with the Commission on April 30,
1998 pursuant to Regulation 14A;
6. Annual Report on Form 10-K for the year ended December 31,
1997, filed with the Commission on April 2, 1998;
7. Report on Form 8-K filed with the Commission on January 26,
1998;
8. The description of the Company's Common Stock contained in the
Company's Registration Statement on Form 8-A filed under the
Exchange Act, including any amendment or report filed for the
purpose of updating such description.
All documents and reports subsequently filed by the Company pursuant to
Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this
Registration Statement and prior to the effective date of this Registration
Statement shall be deemed to be incorporated by reference herein and to be a
part hereof from the date of filing of such documents or reports. Any statement
contained in a document incorporated by reference or deemed to be incorporated
by reference herein shall be deemed to be modified or superseded for purposes of
this Registration Statement to the extent that a statement contained herein or
in any other subsequently filed document which also is or is deemed to be
incorporated by reference herein modifies or supersedes such statement. Any
statement so modified or superseded shall not be deemed, except as so modified
or superseded, to constitute a part of this Registration Statement. The Company
will provide without charge to each person to whom this Registration Statement
is delivered, upon written or oral request, a copy of any or all of the
foregoing documents incorporated by
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reference in this Registration Statement (other than any exhibits thereto).
Requests for such documents should be directed to SciClone Pharmaceuticals, Inc.
at 901 Mariners Island Boulevard, Suite 205, San Mateo, California 94404
(telephone number (650) 358-3456), Attn.: Investor Relations.
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RISK FACTORS
An investment in the Common Stock offered hereby involves a high degree
of risk and the Common Stock should not be purchased by persons who cannot
afford the loss of their entire investment. Purchasers should carefully consider
the following risk factors in conjunction with the other information included
and incorporated by reference in this Prospectus before purchasing or otherwise
acquiring the Common Stock offered hereby.
This Prospectus contains forward-looking statements within the meaning
of Section 27A of the Securities Act and Section 21E of the Securities Exchange
Act and the Company has attempted to identify such statements with an asterisk
("*"). Actual results could differ materially from those projected in these
forward-looking statements as a result of a variety of factors, including those
set forth below and elsewhere in this Prospectus.
DEPENDENCE ON ZADAXIN(R) AND CPX. The Company's principal drug
development efforts are currently focused on ZADAXIN and CPX. Clinical trials of
ZADAXIN sponsored by the Company and/or other parties are currently in progress
or planned and favorable results from such trials will be necessary to gain
regulatory approval in major pharmaceutical markets. Sales of ZADAXIN commenced
in 1997 but are not material at this time. While ZADAXIN has been approved for
commercial sale for treatment of hepatitis B in the People's Republic of China,
Kuwait, Peru, the Philippines and Singapore, no assurance can be given that
ZADAXIN approvals will be obtained in additional countries or for the treatment
of additional indications, such as hepatitis C or cancer, in a timely fashion or
at all. The Company's launch of ZADAXIN in the People's Republic of China, the
Philippines and Singapore is the first commercial introduction of ZADAXIN by the
Company, and no assurance can be given that commercialization of ZADAXIN will
prove successful. The Company has not yet launched ZADAXIN in Argentina, Italy,
Kuwait or Peru and no assurance can be given that future launch of ZADAXIN will
prove successful in these countries or in any additional countries. Future sales
of ZADAXIN will depend on market acceptance and successful distribution. In
particular, although the People's Republic of China has the highest hepatitis B
prevalence rate in the world, the low average income and poorly developed
distribution infrastructure present ongoing challenges to successful
commercialization of ZADAXIN in that market. Because the Company currently
relies on ZADAXIN as its sole source of revenue, the failure to demonstrate the
drug's efficacy in future clinical trials, obtain additional marketing approvals
or commercialize the drug successfully would have a material adverse effect on
the Company.
The Company may experience delays and encounter difficulties in
clinical trials of CPX. In addition, there can be no assurance that any clinical
trial will provide statistically significant evidence of the efficacy of CPX in
treating cystic fibrosis ("CF"). A failure to demonstrate the safety and
efficacy of CPX in a CF clinical trial, obtain regulatory approval of CPX for CF
or successfully commercialize CPX would have a material adverse effect on the
Company.
NO HISTORY OF SIGNIFICANT REVENUES; CONTINUING OPERATING LOSSES. The
Company has only recently generated revenues from the commercialization of its
lead product, ZADAXIN, and there is substantial uncertainty regarding the timing
and amount of any future revenues and whether such future revenues will be
material. The Company cannot predict when or if marketing approvals for CPX will
be obtained or additional marketing approvals for ZADAXIN will be obtained. Even
if such approvals are obtained, there can be no assurance that ZADAXIN and CPX
will be commercialized successfully. The Company has experienced significant
operating losses since its inception and has a substantial accumulated deficit.
The Company expects its operating expenses to increase over the next several
years as it expands its development, clinical testing and marketing
capabilities. The Company's ability to achieve a profitable level of operations
is dependent in large part on successful expansion of the market for ZADAXIN in
Asia, Latin America and the Middle East, obtaining additional regulatory
approvals for ZADAXIN and/or future products, entering into a corporate
partnering arrangement for phase 3 development of the combination of ZADAXIN
plus interferon for hepatitis C in the U.S. and Europe, entering into other
agreements for product development and commercialization, where appropriate, and
continuing to expand from development into successful marketing. There can be no
assurance that the Company will ever achieve a profitable level of operations.
FUTURE CAPITAL NEEDS; UNCERTAINTY OF ADDITIONAL FINANCING. Since
inception, the Company has financed its operations primarily through sales of
equity securities. The Company will need to obtain additional
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financing through sales of equity securities to support its long-term product
development and commercialization programs. The Company believes its existing
capital resources and interest on funds available are adequate to maintain its
current and planned operations at least through June 1999.* The Company is
considering corporate partnering and other opportunities to increase its capital
resources. However, the Company's future capital requirements will depend on
many factors, including the level of ZADAXIN product sales, the availability of
complementary products, technologies and businesses, the initiation of
preclinical and clinical trials and testing, the timing and cost of regulatory
approvals, patent costs, competing technological and market developments, the
nature of existing and future collaborative relationships, and the Company's
ability to establish development, sales, manufacturing and marketing
arrangements. The Company continues to pursue corporate partnering and public
and private financing alternatives. If additional funds are raised by the
Company through the issuance of equity securities or securities convertible into
or exercisable for equity securities, the percentage ownership of the then
current shareholders of the Company will be reduced. The Company may issue a
series of Preferred Stock with rights, preferences and privileges senior to
those of the Company's Common Stock. There can be no assurance that such
financing will be available on acceptable terms or a timely basis, if at all.
The unavailability or timing of financing could prevent or delay the Company's
long-term product development and commercialization programs and may require
curtailment of operations of the Company.
DILUTION; SHARES ELIGIBLE FOR FUTURE SALE. Pursuant to a Structured
Equity Line Flexible Financing(SM) Agreement (the "Equity Line"), entered into
by the Company on June 30, 1998, the Company, subject to certain limitations,
may issue to the purchaser under the Equity Line up to $4.0 million of Common
Stock during each Investment Period (or $32 million in the aggregate) at a price
equal to 97% of the lowest reported sale price during the four days immediately
preceding the notice of purchase delivered by the purchaser to the Company.
Issuances, if any, of Common Stock pursuant to the Equity Line would have a
dilutive effect on existing holders of Common Stock. In connection with the
Equity Line, the Company also issued to the purchaser a warrant (the "Warrant")
to purchase 200,000 shares of Common Stock at $5.53 per share and may issue
additional warrants (the "Additional Warrants") to purchase up to an additional
300,000 shares of Common Stock at a price equal to 150% of the weighted average
purchase price of the Common Stock purchased during the year with respect to
which the Additional Warrant is issued. The resale by the purchaser of the
Common Stock that it acquires could depress the market price of the Common
Stock. Moreover, as all the shares to be issued pursuant to the Equity Line as
well as the shares issuable upon exercise of the Warrant and the Additional
Warrants, if any, will be available for immediate resale, the prospects of such
sales could further adversely affect the market price for the Common Stock. The
Company recently issued shares of Series C Preferred Stock (the "Series C
Shares") in a private placement with proceeds of $4,000,000 (before deducting
offering expenses). Under certain conditions, each Series C Share may convert
into substantially more than one share of the Company's Common Stock. If such
events were to occur, the conversion of the Series C Shares would have a
dilutive effect on the common shareholders.
DEPENDENCE ON THIRD PARTIES. The Company's strategy contemplates that
it will enter into various arrangements with other entities. To date, the
Company has acquired rights to ZADAXIN, CPX and certain other drugs but is only
actively pursuing clinical development of ZADAXIN and CPX. Failure to license or
otherwise acquire rights to additional drugs would result in a shortage of
products for development. In addition, the Company has licensed exclusive rights
to develop and market ZADAXIN in Japan to Schering-Plough K.K. ("SPKK"). SPKK
has a substantial commitment to alpha interferon, which is an approved therapy
for hepatitis B and hepatitis C in Japan. There can be no assurance that the
relationship will prove successful or that the Company will be able to negotiate
additional arrangements in the future. The amount and timing of resources that
collaborators devote to their activities with the Company will not be within the
control of the Company and may be affected by financial difficulties or other
factors affecting these third parties. There can be no assurance that such
parties will perform their obligations as expected. Moreover, the Company's
ability to obtain regulatory approval in one country may be delayed or adversely
affected by the timing of regulatory activities and approvals in one or more
other countries, particularly if the Company does not participate in the
regulatory approval process in such other countries.
FOREIGN SALES AND OPERATIONS. The Company's financial condition in the
near term will be highly dependent on ZADAXIN sales in foreign jurisdictions,
where sales and operations are subject to inherent risks, including difficulties
and delays in obtaining pricing approvals and reimbursement, unexpected changes
in regulatory requirements, tariffs and other barriers, political instability,
difficulties in staffing and managing foreign
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operations, longer payment cycles, greater difficulty in accounts receivable
collection, currency fluctuations and potential adverse tax consequences.
Certain foreign countries regulate pricing of pharmaceuticals and such
regulation may result in prices significantly below those that would prevail in
a free market. The majority of the Company's current sales are to customers in
the People's Republic of China where the Company's accounts receivable
collection terms are typically 180 days. Such collections are currently being
paid on time, however, payments have been delayed in the past and may slow in
the future.
PATENTS AND PROPRIETARY RIGHTS. The U.S. and most European composition
of matter patents for thymosin alpha 1 have expired. The Company will in the
future have only limited composition of matter patents for thymosin alpha 1 or
other products and this could adversely affect the Company's proprietary rights.
However, the Company owns or has exclusive licenses for use and/or process
patents or patent applications in the U.S., Europe, Japan and other
jurisdictions for thymosin alpha 1, and for CPX in the U.S. and will seek to
protect such products from competition through such patent protection and
through other means. The Company's success is significantly dependent on its
ability to obtain patent protection for its products and technologies and to
preserve its trade secrets and operate without infringing on the proprietary
rights of third parties. No assurance can be given that the Company's pending
patent applications will result in the issuance of patents or that any patents
will provide competitive advantages or will not be invalidated or circumvented
by its competitors. Moreover, no assurance can be given that patents are not
issued to, or patent applications have not been filed by, other companies which
would have an adverse effect on the Company's ability to use, manufacture or
market its products or maintain its competitive position with respect to its
products. Numerous patents and patent applications relating to thymosin alpha 1
are held under exclusive license and the breach by the Company of the terms of
such license could result in the loss of the Company's rights to such patents
and patent applications. Other companies obtaining patents claiming products or
processes useful to the Company may bring infringement actions against the
Company and such litigation is typically costly and time-consuming. As a result,
the Company may be required to obtain licenses from others or not be able to
use, manufacture or market its products. Such licenses may not be available on
commercially reasonable terms, if at all.
The patent positions of biotechnology firms generally are highly
uncertain and involve complex legal and factual questions. No consistent policy
has emerged regarding the validity and scope of claims in biotechnology patents,
and courts have issued varying interpretations in the recent past, and legal
standards concerning validity, scope and interpretations of claims in
biotechnology patents may continue to evolve. Even issued patents may later be
modified or revoked by the U.S. Patent and Trademark Office, the European Patent
Office or the courts in proceedings instituted by third parties. Moreover, the
issuance of a patent in one country does not assure the issuance of a patent
with similar claims in another country and claim interpretation and infringement
laws vary among countries, so the extent of any patent protection is uncertain
and may vary in different countries.
Pharmaceuticals are not patentable in certain countries in SciClone's
ZADAXIN territory, or have only recently become patentable, and enforcement of
intellectual property rights in many countries in such territory has been
limited or non-existent. Future enforcement of patents and proprietary rights in
many countries in SciClone's ZADAXIN territory can be expected to be problematic
or unpredictable. There can be no assurance that any patents issued or licensed
to the Company will provide it with competitive advantages or will not be
challenged by others. No assurance can be given that holders of patents licensed
to the Company will file, prosecute, extend or maintain their patents in
countries where the Company has rights. Furthermore, there can be no assurance
that others will not independently develop similar products or will not design
around patents issued or licensed to the Company.
GOVERNMENT REGULATION AND PRODUCT APPROVALS. The research, preclinical
and clinical development, manufacturing, marketing and sales of pharmaceuticals,
including ZADAXIN, CPX and the Company's other drug candidates, are subject to
extensive regulation by governmental authorities. Products developed by the
Company cannot be marketed commercially in any jurisdiction in which they have
not been approved. The process of obtaining regulatory approvals is lengthy and
requires the expenditure of substantial resources. In some countries where the
Company contemplates marketing ZADAXIN, the regulatory approval process for
drugs not previously approved in countries that have established clinical trial
review procedures is uncertain and this uncertainty may result in delays in
granting regulatory approvals. In addition, in certain countries such as Japan,
the process for obtaining regulatory approval is time consuming and costly
because all clinical trials and most preclinical studies
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must be conducted there. The Company is currently sponsoring clinical trials and
pursuing regulatory approvals of ZADAXIN in a number of countries and of CPX in
the U.S., but there can be no assurance that the Company will be able to
complete such trials, that such trials, if completed, will fulfill regulatory
approval criteria or that the Company will ultimately obtain approvals in such
countries. Adverse results in the Company's development programs also could
result in the placement of restrictions on the use of ZADAXIN and CPX or
revocation of the approval. The marketing approval for ZADAXIN in Singapore
requires a patient surveillance program to continue study of the drug's safety
and efficacy. Adverse results in such program could result in the placement of
restrictions on the use of ZADAXIN or revocation of the approval in Singapore.
Failure to comply with the applicable U.S. or foreign regulatory requirements
can, among other things, result in Warning Letters, fines, suspensions of
regulatory approvals, product recalls or seizures, operating restrictions,
injunctions and criminal prosecutions. Further, additional government regulation
may be established or imposed which could prevent or delay regulatory approval
of ZADAXIN, CPX or any future products of the Company.
MANUFACTURING. The Company has entered into contract manufacturing and
supply agreements to source ZADAXIN and CPX. The Company has experienced delays
of supply of thymosin alpha 1 bulk drug in the past and could do so again in the
future. To be successful, the Company's products must be manufactured in
commercial quantities in compliance with regulatory requirements and at an
acceptable cost. While the Company believes it has and will be able in the
future to establish manufacturing relationships with experienced suppliers
capable of meeting the Company's needs, there can be no assurance that the
Company will establish long term manufacturing relationships with suppliers or
that these suppliers will prove satisfactory. The Company currently has vialing
and packaging supply agreements in effect and has a sufficient supply of
finished thymosin alpha 1 for the near term. Production interruptions, if they
occur, could significantly delay clinical development of potential products,
reduce third party or clinical researcher interest and support of proposed
clinical trials. Such interruptions could also delay commercialization of the
Company's products and impair their competitive position, which would have a
material adverse effect on the business and financial condition of the Company.
MARKETING AND SALES. The Company has established distribution
arrangements with local pharmaceutical distribution companies covering countries
in Asia, Latin America and the Middle East. However, no assurance can be given
that any such distribution arrangements will remain in place or prove
successful.
TECHNOLOGICAL CHANGE AND COMPETITION. Rapid technological development
may result in the Company's products becoming obsolete before they are marketed
or before the Company recovers a significant portion of the related development
and commercialization expenses. Competition in the pharmaceutical field is
intense and the Company expects that competition will increase. The Company's
competitors include major pharmaceutical companies, biotechnology firms and
universities and other research institutions, both in the U.S. and abroad, that
are actively engaged in research and development of products in the therapeutic
areas being pursued by the Company. Many of these companies and institutions
have substantially greater financial, technical, regulatory, manufacturing,
marketing and human resource capabilities than the Company and extensive
experience in undertaking clinical testing and obtaining regulatory approvals
necessary to market drugs. Principal competitive factors in the pharmaceutical
field include efficacy, safety, price and therapeutic regimen. Where comparable
products are marketed by other companies price is also a competitive factor.
UNCERTAINTY OF THIRD PARTY REIMBURSEMENT; RESOURCES OF PATIENT
POPULATIONS. The Company's ability successfully to commercialize its products
may depend in part on the extent to which reimbursement for the cost of such
products will be available from government health administration authorities,
private health insurers and other organizations. Significant uncertainty exists
as to the reimbursement status of new therapeutic products and there can be no
assurance that third party reimbursement will be available for therapeutic
products the Company might develop. In many of the foreign countries in which
the Company intends to operate, reimbursement of ZADAXIN under government or
private health insurance programs will not be available. In the U.S., health
care reform is an area of increasing national attention and a priority of many
governmental officials. Certain reform proposals, if adopted, could impose
limitations on the prices the Company will be able to charge in the U.S. for its
products or the amount of reimbursement for the Company's products from
governmental agencies or third party payers. In many countries where the Company
markets and sells or intends to market and sell ZADAXIN, government resources
and per capita income levels may be so low that the Company's products will be
prohibitively expensive
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for a large percentage of the population. In such countries, there can be no
assurance that the Company will be successful in marketing its products on
economically favorable terms, if at all.
DEPENDENCE ON QUALIFIED PERSONNEL AND KEY INDIVIDUALS. Because of the
specialized scientific nature of the Company's business, the Company is highly
dependent upon its ability to continue to attract and retain qualified
management, scientific and technical personnel. There is intense competition for
qualified personnel in the areas of the Company's activities, and there can be
no assurance that the Company will be able to continue to attract and retain the
qualified personnel necessary for the development of its business. In addition,
many key responsibilities within the Company have been assigned to a relatively
small number of individuals. Loss of the services of any of these individuals
unless they were promptly replaced could be significantly detrimental to the
Company's development. The Company does not maintain key person life insurance
on the lives of any of its key personnel.
PRODUCT LIABILITY; ABSENCE OF INSURANCE. The Company's business will
expose it to potential product liability risks which are inherent in the
testing, manufacturing, marketing and sale of pharmaceutical products, and there
can be no assurance that product liability claims will not be asserted against
the Company. Product liability insurance for the pharmaceutical industry
generally is expensive to the extent that it is available at all. The Company
has product liability insurance coverage for clinical trials and commercial
sales. However, there can be no assurance that a product liability claim would
not adversely affect the business or financial condition of the Company.
PREFERRED STOCK. The Company's Board of Directors has the authority to
issue additional series of preferred stock and to determine the price, rights,
preferences, privileges and restrictions, including voting rights, without any
further vote or action by the Company's shareholders. The rights of the holders
of the Common Stock will be subject to, and may be adversely affected by, the
rights of the holders of any Preferred Stock that may be issued in the future.
The issuance of Preferred Stock, while providing desirable flexibility in
connection with possible acquisitions and other corporate purposes, could have
the effect of making it more difficult for a third party to acquire a majority
of the outstanding voting stock of the Company.
8
<PAGE> 10
THE COMPANY
GENERAL
SciClone Pharmaceuticals, Inc. ("SciClone" or the "Company") is a
global biopharmaceutical company that acquires, develops, and commercializes
specialist-oriented drugs for treating chronic and life-threatening diseases
such as hepatitis B, hepatitis C, cancer, immune system disorders and cystic
fibrosis. SciClone has two drugs in clinical development, ZADAXIN(R) thymosin
alpha 1 and CPX, and has other drug candidates in preclinical development.
ZADAXIN thymosin alpha 1, an immunomodulator (i.e., an immune system
regulator), is the Company's lead drug, targeting hepatitis B, hepatitis C,
cancer, viral vaccine enhancement and certain immune system disorders. ZADAXIN
is approved and marketed in the People's Republic of China, the Philippines and
Singapore for treatment of hepatitis B, one of the most common chronic
infectious diseases in the world. In the first quarter of 1998, ZADAXIN was
approved in Kuwait and Peru for treatment of hepatitis B, and in Argentina for
use as an influenza vaccine adjuvant. ZADAXIN is also approved in Italy for use
as an influenza vaccine adjuvant. ZADAXIN has now been approved in each of the
three primary regions SciClone has targeted for hepatitis B sales -- Asia, Latin
America and the Middle East. The Company has filed for approval to market
ZADAXIN in additional countries in Asia, Latin America and the Middle East.
SciClone has worldwide marketing, development and manufacturing rights to
ZADAXIN, except in Japan, where the Company's rights have been sublicensed.
In the U.S. and Europe, the Company is planning phase 3 development of
the combination of ZADAXIN plus interferon for the treatment of hepatitis C, a
worldwide epidemic affecting over 170 million people including over ten million
people in the U.S., Europe and Japan, the world's largest pharmaceutical
markets. Clinical data demonstrate that the combination of ZADAXIN plus
interferon could be a significant therapeutic advance in the fight against
hepatitis C. Interferon, the only established first-line therapy to treat
hepatitis C, leads to a sustained response in only 5% to 20% of patients and
causes unpleasant side effects. The Company is pursuing a corporate partnering
arrangement for phase 3 development of the combination of ZADAXIN plus
interferon for hepatitis C in the U.S. and Europe.* In Italy, a ZADAXIN
marketing application for treatment of non small-cell lung cancer is pending.
The Company also is planning a U.S. phase 2 study of ZADAXIN plus TACE
(transarterial chemo-emobilization) in liver cancer.
In Japan, the world's leading market for viral hepatitis therapies, the
Company has licensed exclusive development and marketing rights to ZADAXIN to
Schering-Plough K.K. ("SPKK"), the Japanese subsidiary of Schering-Plough
Corporation (NYSE:SGP), a leading marketer of viral hepatitis therapies
worldwide. In the second quarter of 1998, SPKK started a 300-patient pivotal
phase 3 ZADAXIN hepatitis B trial in Japan. SPKK also is developing ZADAXIN in a
phase 2 hepatitis C study.
CPX is SciClone's second drug in clinical development. CPX is an orally
administered protein-repair therapy initially developed by the U.S. National
Institutes of Health ("NIH") as a potential treatment for cystic fibrosis
("CF"). SciClone acquired an exclusive license to CPX from the NIH. CF is caused
by mutations in the gene that encodes the cystic fibrosis transmembrane
conductance regulator ("CFTR") protein. More than 70% of CF patients have the
delta F508 mutation. In October 1997, Harvey Pollard, M.D., Ph.D, of the
Uniformed Services University of the Health Sciences and formerly of the NIH,
presented breakthrough new preclinical data demonstrating that CPX corrects the
two key molecular defects causing CF in patients with the F508 mutation impaired
chloride ion transport and abnormal CFTR trafficking. These preclinical data
indicate that CPX is the only drug in clinical development with the potential to
correct the two key molecular defects in most CF patients. The Company has
obtained orphan drug status for CPX from the United States Food and Drug
Administration ("FDA"). In 1997, the FDA awarded the Company a $100,000 research
grant for phase 1 development of CPX. The Company completed phase 1 development
of CPX in CF patients in April 1998 and expects to begin phase 2 development in
CF patients in the third quarter of 1998.*
9
<PAGE> 11
OTHER INFORMATION
The Company was incorporated in California in 1990. Its principal
executive offices are located at 901 Mariners Island Boulevard, Suite 205, San
Mateo, California 94404, and its telephone number is (650) 358-3456. The
Company's international operating subsidiary, SciClone Pharmaceuticals
International Ltd. ("SciClone International"), is incorporated in the Cayman
Islands and headquartered in Hong Kong. The Company also has office locations in
Singapore, Taiwan and Japan.
USE OF PROCEEDS
In connection with the Acquisition Agreement, the Company agreed to
loan Alpha 1 up to $280,000, in monthly installments of $70,000. Alpha 1 agreed
to repay these amounts in monthly installments of $70,000, beginning on the
earlier of (a) the ninth month following the closing of the transaction, or (b)
the receipt by Alpha 1 of equity financing of at least $500,000. If Alpha 1
repays such amounts in accordance with such schedule, Alpha 1 shall not be
required to pay interest on such amounts. During 1998, the Company also has
loaned an additional $140,000 to Alpha 1 pursuant to separate promissory notes
which bear interest at 8% per annum. The Company believes Alpha 1 may use a
portion of its proceeds from sales of the Shares to repay some or all of its
outstanding indebtedness to the Company. To the extent such proceeds are used to
repay debt owed to the Company, such amounts will be used by the Company for
working capital and general corporate purposes.
10
<PAGE> 12
SELLING SHAREHOLDER
The Selling Shareholder will hold shares of Common Stock which were
issued or are issuable in connection with the acquisition of certain rights
related to thymosin alpha 1. The table below sets forth the Selling Shareholder,
the number of shares of Common Stock which it owns or has the right to acquire
as of August 20, 1998, the number of shares of Common Stock subject to sale
pursuant to this Registration Statement and the number of shares of Common Stock
it would own assuming sale of all shares of Common Stock registered by this
Registration Statement.
<TABLE>
<CAPTION>
Shares Beneficially Shares Offered Shares Beneficially
Owned Prior to the this by Owned After
Selling Shareholder (1) Offering Prospectus the Offering (3)
----------------------- -------- ---------------- ----------------
<S> <C> <C> <C>
Alpha 1 Biomedicals, Inc. 600,000(2) 600,000(2) --
</TABLE>
- ---------------------
(1) The persons named in the table have sole voting and investment power
with respect to all shares of SciClone Common Stock shown as
beneficially owned by them, subject to community property laws, where
applicable.
(2) The number of shares set forth in the table represents the maximum
number of shares of Common Stock to be offered by the Selling
Shareholder. 444,115 shares were issued in connection with the closing
of the Acquisition Agreement and up to 155,885 shares are issuable in
decreasing monthly increments during the 12 months following the
effective date of the registration statement.
(3) Assumes the sale of all shares offered hereby.
11
<PAGE> 13
PLAN OF DISTRIBUTION
The Selling Shareholder, acting as principal for its own account,
directly, through agents designated from time to time, or through brokers,
dealers, agents or underwriters also to be designated, may sell all or a portion
of the Shares from time to time on terms to be determined at the time of sale.
The Selling Shareholder may from time to time sell all or a portion of the
Shares in routine brokerage transactions on the Nasdaq Stock Market or otherwise
at the prices and terms prevailing at the time of the sale. The Selling
Shareholder also may make private resales directly or through brokers or may
make resales pursuant to Rule 144 under the Securities Act. The Selling
Shareholder may pay customary brokerage fees, commissions and expenses. Alpha 1
agreed to limit the number of shares of the Company's common stock it will sell
each month to 50,000 shares during the 12 months following the effective date of
the registration statement.
To the extent required pursuant to Rule 424 under the Securities Act, a
Prospectus Supplement will be filed with the Securities and Exchange Commission
with respect to a particular offering setting forth the terms of any offering,
including the name or names of any underwriters or agents, if any, any
underwriting discounts and other items constituting underwriters' compensation,
the offering price and any discounts or concessions allowed or reallowed or paid
to dealers. Any offering price and any discounts or concessions allowed or
reallowed or paid to dealers may be changed from time to time.
If underwriters are used in a sale, shares of Common Stock will be
acquired by the underwriters for their own account and may be resold from time
to time in one or more transactions, including negotiated transactions, at a
fixed public offering price or at varying prices determined at the time of sale.
The shares may be offered to the public either through underwriting syndicates
represented by one or more managing underwriters or directly by one or more
firms acting as underwriters. The underwriter or underwriters with respect to a
particular underwritten offering of shares to be named in the Prospectus
Supplement relating to such offering and, if an underwriting syndicate is used,
the managing underwriter or underwriters, will be set forth on the cover of such
Prospectus Supplement. Unless otherwise set forth in the Prospectus Supplement
relating thereto, the obligations of the underwriters to purchase the Shares
will be subject to conditions precedent and the underwriters will be obligated
to purchase all of the shares if any are purchased.
If dealers are utilized in the sale of shares of Common Stock in
respect of which this Prospectus is delivered, the Selling Shareholder will sell
such shares to the dealers as principals. The dealers may then resell such
shares to the public at varying prices to be determined by such dealers at the
time of resale. The names of the dealers and the terms of the transaction will
be set forth in a Prospectus Supplement relating thereto.
If an agent is used, the agent will be named, and the terms of the
agency and any commissions will be set forth in a Prospectus Supplement relating
thereto. Unless otherwise indicated in the Prospectus Supplement, any such agent
will be acting on a best efforts basis for the period of its appointment.
Shares may be sold directly by the Selling Shareholder to institutional
investors or others, who may be deemed to be underwriters within the meaning of
the Securities Act with respect to any resale thereof. The terms of any such
sales, including the terms of any bidding or auction process, will be described
in the Prospectus Supplement relating thereto.
Agents, dealers and underwriters may be entitled under agreements
entered into with the Selling Shareholder to indemnification against certain
civil liabilities, including liabilities under the Securities Act, or to
contribution with respect to payments which such agents, dealers or underwriters
may be required to make in respect thereof. Agents, dealers and underwriters may
be customers of, engage in transactions with, or perform services for the
Company or the Selling Shareholder in the ordinary course of business.
The Company will bear all costs and expenses of the registration of the
Shares under the Securities Act and certain state securities laws. The Selling
Shareholder will pay any transaction costs associated with effecting any sales
that occur.
12
<PAGE> 14
The Selling Shareholder is not restricted as to the price or prices at
which it may resell Shares. Such resales may have an adverse effect on the
market price of the Common Stock. In addition, it is possible that a significant
number of Shares could be sold at the same time, which also may have an adverse
effect on the market price of the Common Stock.
The Company has agreed to indemnify the Selling Shareholder against
certain civil liabilities, including liabilities under the Securities Act.
LEGAL MATTERS
The legality of the Shares is being passed upon by Gray Cary Ware &
Freidenrich LLP, Palo Alto, California.
EXPERTS
The consolidated financial statements and schedule of the Company
appearing in its Annual Report (Form 10-K/A and Form 10-K) for the year ended
December 31, 1997 have been audited by Ernst & Young LLP, independent auditors,
as set forth in their report thereon, included therein and incorporated herein
by reference. Such consolidated financial statements and schedule are
incorporated herein by reference in reliance upon such report given upon the
authority of such firm as experts in accounting and auditing.
13
<PAGE> 15
================================================================================
NO DEALER, SALESMAN OR OTHER PERSON HAS BEEN AUTHORIZED TO GIVE ANY INFORMATION
OR TO MAKE ANY REPRESENTATIONS OTHER THAN THOSE CONTAINED OR INCORPORATED BY
REFERENCE IN THIS PROSPECTUS IN CONNECTION WITH THE OFFERING DESCRIBED HEREIN,
AND, IF GIVEN OR MADE, SUCH INFORMATION OR REPRESENTATION MUST NOT BE RELIED
UPON AS HAVING BEEN AUTHORIZED BY THE COMPANY. THIS PROSPECTUS DOES NOT
CONSTITUTE AN OFFER TO SELL, OR A SOLICITATION OF AN OFFER TO BUY, ANY
SECURITIES OTHER THAN THE REGISTERED SECURITIES TO WHICH IT RELATES, OR AN OFFER
TO SELL, OR A SOLICITATION OF AN OFFER TO BUY, IN ANY JURISDICTION IN WHICH IT
IS UNLAWFUL TO MAKE SUCH OFFER OR SOLICITATION. NEITHER THE DELIVERY OF THIS
PROSPECTUS NOR ANY SALE MADE HEREUNDER SHALL, UNDER ANY CIRCUMSTANCES, CREATE AN
IMPLICATION THAT THERE HAS BEEN NO CHANGE IN THE AFFAIRS OF THE COMPANY SINCE
THE DATE HEREOF OR THAT THE INFORMATION CONTAINED HEREIN IS CORRECT AS OF ANY
TIME SUBSEQUENT TO THE DATE HEREOF.
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
----
<S> <C>
Available Information .............................................. 2
Incorporation of Certain Documents By
Reference ...................................................... 2
Risk Factors ....................................................... 4
The Company ........................................................ 9
Use of Proceeds .................................................... 10
Selling Shareholder ................................................ 11
Plan of Distribution ............................................... 12
Legal Matters ...................................................... 13
Experts ............................................................ 13
</TABLE>
600,000 SHARES
SCICLONE PHARMACEUTICALS, INC.
COMMON STOCK
-----------------
PROSPECTUS
-----------------
_______________, 1998
================================================================================
<PAGE> 16
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The following table sets forth the costs and expenses in connection
with the sale and distribution of the securities being registered, other than
underwriting discounts and commissions. All of the amounts shown are estimates
except the Securities and Exchange Commission registration fees and Nasdaq
filing fee.
<TABLE>
<CAPTION>
To be Paid
By The
Registrant
----------
<S> <C>
SEC Registration Fee ................................ $ 388
Nasdaq filing fee ................................... $ 17,500
Accounting fees and expenses ........................ $ 7,500
Legal fees and expenses ............................. $ 26,000
Miscellaneous expenses .............................. $ 3,612
Total....................................... $ 55,000
==========
</TABLE>
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
As permitted by Section 204 of the California Corporations Code (the
"CCC"), the Registrant's Articles of Incorporation provide that each person who
is or was or who had agreed to become a director or officer of the Registrant or
who had agreed at the request of the Registrant's Board of Directors or an
officer of the Registrant to serve as an employee or agent of the Registrant or
as a director, officer, employee or agent of another corporation, partnership,
joint venture, trust or other enterprise, shall be indemnified by the Registrant
to the full extent permitted by the CCC or any other applicable laws. Such
Articles of Incorporation also provide that no amendment or repeal of such
Articles shall apply to or have any effect on the right to indemnification
permitted or authorized thereunder for or with respect to claims asserted before
or after such amendment or repeal arising from acts or omissions occurring in
whole or in part before the effective date of such amendment or repeal.
The Registrant's Bylaws provide that the Registrant shall indemnify to
the full extent authorized by law any person made or threatened to be made a
party to an action or a proceeding, whether criminal, civil, administrative or
investigative, by reason of the fact that he, his testator or intestate was or
is a director, officer or employee of the Registrant or any predecessor of the
Registrant or serves or served any other enterprise as a director, officer or
employee at the request of the Registrant or an predecessor of the Registrant.
The Registrant's Bylaws also provide that the Registrant may enter into one or
more agreements with any person which provides for indemnification greater or
different than that provided in such Articles of Incorporation.
The Registrant has entered into indemnification agreements with its
directors and certain of its officers.
The Registrant intends to purchase and maintain insurance on behalf of
any person who is a director or officer against any loss arising from any claim
asserted against him and incurred by him in any such capacity, subject to
certain exclusions.
See also the undertakings set out in response to Item 17 herein.
II-1
<PAGE> 17
ITEM 16. EXHIBITS.
The following exhibits are filed with this Registration Statement:
<TABLE>
<CAPTION>
EXHIBIT NO. DESCRIPTION OF EXHIBIT
----------- ----------------------
<S> <C>
4.1* Alpha Rights Acquisition Agreement by and between the Company
and Alpha 1 Biomedicals, Inc., dated December 17, 1997.
5.1 Opinion of Gray Cary Ware & Freidenrich LLP.
23.1 Consent of Ernst & Young LLP, independent auditors.
23.2 Consent of Gray Cary Ware & Freidenrich LLP (included in
Exhibit 5.1).
24.1 Power of Attorney (included in the Signature Page contained in
Part II of the Registration Statement).
</TABLE>
- ------------------
* Incorporated by reference from the Company's report on Form 8-K filed
with the Commission on January 26, 1998.
ITEM 17. UNDERTAKINGS.
A. The undersigned Registrant hereby undertakes:
(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 (the "Securities Act");
(ii) To reflect in the prospectus any facts or events
arising after the effective date of the 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 the
registration statement. Notwithstanding the foregoing, any increase or decrease
in volume of securities offered (if the total dollar value of securities offered
would not exceed that which was registered) and any deviation from the low or
high end of the estimated maximum offering range may be reflected in the form of
prospectus filed with the Commission pursuant to Rule 424(b) if, in the
aggregate, the changes in volume and price represent no more than a 20% change
in the maximum aggregate offering price set forth in the "Calculation of
Registration Fee" table in the effective registration statement;
(iii) To include any material information with
respect to the plan of distribution not previously disclosed in the registration
statement or any material change to such information in the registration
statement; provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) do not
apply if the information required to be included in a post-effective amendment
by those paragraphs is contained in periodic reports filed by the Registrant
pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934
that are incorporated by reference in the registration statement.
(2) That, for the purpose of determining any liability under
the Securities Act, each such post-effective amendment shall be deemed to be a
new registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof.
II-2
<PAGE> 18
(3) To remove from registration by means of a post-effective
amendment any of the securities being registered which remain unsold at the
termination of the offering.
B. The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act, each filing of the
Registrant's annual report pursuant to section 13(a) or section 15(d) of the
Securities Exchange Act of 1934 that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
C. The undersigned Registrant hereby undertakes to deliver or cause to
be delivered with the prospectus, to each person to whom the prospectus is sent
or given, the latest annual report to security holders that is incorporated by
reference in the prospectus and furnished pursuant to and meeting the
requirements of Rule 14a-3 or Rule 14c-3 under the Securities Exchange Act of
1934; and, where interim financial information required to be presented by
Article 3 of Regulation S-X are not set forth in the prospectus, to deliver, or
cause to be delivered to each person to whom the prospectus is sent or given,
the latest quarterly report that is specifically incorporated by reference in
the prospectus to provide such interim financial information.
D. Insofar as indemnification for liabilities arising under the
Securities Act may be permitted to directors, officers, and controlling persons
of the Registrant pursuant to the foregoing provisions, or otherwise, the
Registrant has been advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the
Registrant 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, 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 and will be governed by the final adjudication of such issue.
E. The undersigned Registrant hereby undertakes that:
(1) For the purposes of determining any liability under the
Securities Act, the information omitted from the form of prospectus filed as
part of this registration statement in reliance upon Rule 430A and contained in
a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4)
or 497(h) under the Securities Act shall be deemed to be part of the
registration statement as of the time it was declared effective.
(2) For the purposes of determining any liability under the
Securities Act, each post-effective amendment that contains a form of prospectus
shall be deemed to be a new registration statement relating to the securities
offered therein, and the offering of such securities at that time shall be
deemed to be the initial bona fide offering thereof.
II-3
<PAGE> 19
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
Registrant certifies that it has reasonable grounds to believe that 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, thereunto duly
authorized in the City of San Mateo, State of California on August 26, 1998.
SCICLONE PHARMACEUTICALS, INC.
By: /s/ DONALD R. SELLERS
-------------------------------------
Donald R. Sellers
President and Chief Executive Officer
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below constitutes and appoints Donald R. Sellers and Shawn K. Singh, and
each of them, as his or her true and lawful attorneys-in-fact and agents, with
full power of substitution and resubstitution, for him or her and in his or her
name, place and stead, in any and all capacities, to sign any and all amendments
(including post-effective amendments) to this Registration Statement on Form
S-3, and to file the same, with all exhibits thereto, and other documents in
connection therewith, with the Securities and Exchange Commission, granting unto
said attorneys-in-fact and agents, and each of them, full power and authority to
do and perform each and every act and thing requisite and necessary to be done
in connection therewith, as fully to all intents and purposes as he or she might
or could do in person, hereby ratifying and confirming all that said
attorney-in-facts and agents, or either of them, or their or his substitute or
substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in the
capacities and on the dates indicated:
<TABLE>
<CAPTION>
SIGNATURE TITLE DATE
--------- ----- ----
<S> <C> <C>
/s/DONALD R. SELLERS
- ------------------------
Donald R. Sellers President, Chief Executive Officer and August 26, 1998
Director (Principal Executive Officer)
/s/ JERE E. GOYAN,
- ------------------------
Jere E. Goyan, Ph.D. Chairman of the Board and Director August 26, 1998
/s/ DIANE LEE
- ------------------------
Diane Lee Director, Corporate Finance and Administration August 26, 1998
(Principal Financial and Accounting Officer)
/s/ JOHN D. BAXTER
- ------------------------
John D. Baxter, M.D. Director August 26, 1998
/s/ EDWIN C. CADMAN
- ------------------------
Edwin C. Cadman, M.D. Director August 26, 1998
/s/ ROLF H. HENEL
- ------------------------
Rolf H. Henel Director August 26, 1998
</TABLE>
II-4
<PAGE> 20
INDEX TO EXHIBITS
<TABLE>
<CAPTION>
EXHIBIT NO. DESCRIPTION OF EXHIBIT
----------- ----------------------
<S> <C>
4.1* Alpha Rights Acquisition Agreement by and between the Company
and Alpha 1 Biomedicals, Inc., dated December 17, 1997.
5.1 Opinion of Gray Cary Ware & Freidenrich LLP.
23.1 Consent of Ernst & Young LLP, independent auditors.
23.2 Consent of Gray Cary Ware & Freidenrich LLP (included in
Exhibit 5.1).
24.1 Power of Attorney (included in the Signature Page contained in
Part II of the Registration Statement).
</TABLE>
- ----------------------------
* Incorporated by reference from the Company's report on Form 8-K filed
with the Commission on January 26, 1998.
<PAGE> 1
[GRAY CARY WARE & FREIDENRICH LLP LETTERHEAD]
EXHIBIT 5.1
August 26, 1998
Securities and Exchange Commission
450 Fifth Street, N.W
Washington, D.C. 20549
RE: SCICLONE PHARMACEUTICALS, INC.
REGISTRATION STATEMENT ON FORM S-3
Ladies and Gentlemen:
As legal counsel for SciClone Pharmaceuticals, Inc., a California corporation
(the "Company"), we are rendering this opinion in connection with the
preparation and filing of a registration statement on Form S-3 (the
"Registration Statement") relating to the registration under the Securities Act
of 1933, as amended, of 600,000 shares (the "Registered Shares") of Common
Stock, no par value (the "Common Stock"), issued or issuable by the Company in
connection with the acquisition (the "Acquisition") of certain rights related to
thymosin alpha 1.
We have examined such instruments, documents and records as we deemed relevant
and necessary for the basis of our opinion hereinafter expressed. In such
examination, we have assumed the genuineness of all signatures and the
authenticity of all documents submitted to us as originals and the conformity to
the originals of all documents submitted to us as copies.
Based on such examination, we are of the opinion that the 444,115 Registered
Shares of Common Stock of the Company issued to the purchaser are, and the
155,885 Registered Shares of Common Stock of the Company issuable to the
purchaser, when issued to the purchaser in accordance with the terms of the
Acquisition, will be, duly authorized shares, validly issued, fully paid, and
nonassessable.
We hereby consent to the filing of this opinion as an exhibit to the
Registration Statement referred to above and the use of our name wherever it
appears in said Registration Statement.
This opinion is to be used only in connection with the issuance of the Common
Stock while the Registration Statement is in effect.
Respectfully submitted,
/s/ GRAY CARY WARE & FREIDENRICH LLP
- --------------------------------------
GRAY CARY WARE & FREIDENRICH LLP
<PAGE> 1
EXHIBIT 23.1
CONSENT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS
We consent to the reference to our firm under the caption "Experts" in the
Registration Statement on Form S-3 and related Prospectus of SciClone
Pharmaceuticals, Inc. for the registration of 600,000 shares of its Common
Stock and to the incorporation by reference therein of our report dated
January 16, 1998, except Note 10, as to which date is April 2, 1998, with
respect to the consolidated financial statements and schedule of SciClone
Pharmaceuticals, Inc. included in its Annual Report on Form 10-K/A and Form 10-K
for the year ended December 31, 1997, filed with the Securities and Exchange
Commission.
/s/ ERNST & YOUNG LLP
Palo Alto, California
August 21, 1998
