<PAGE>
AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON MARCH 10, 1995
REGISTRATION NO. 33-88800
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
------------
AMENDMENT NO 1
TO
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
-----------
SCIOS NOVA INC.
(Exact name of registrant as specified in its charter)
DELAWARE 2834 95-3701481
(State or other jurisdic- (Primary Standard (I.R.S. Employer
tion of incorporation or Industrial Classification Identification Number)
organization) Code Number)
-------------
2450 BAYSHORE PARKWAY
MOUNTAIN VIEW, CALIFORNIA 94043-1173
(415) 966-1550
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
-------------
JOHN H. NEWMAN
VICE PRESIDENT
SCIOS NOVA INC.
2450 BAYSHORE PARKWAY
MOUNTAIN VIEW, CALIFORNIA 94043-1173
(415) 966-1550
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
-------------
COPIES TO:
ANDREI M. MANOLIU, ESQ.
COOLEY GODWARD CASTRO
HUDDLESON & TATUM
FIVE PALO ALTO SQUARE
PALO ALTO, CALIFORNIA 94306
(415) 843-5000
-------------
Approximate date of commencement of proposed sale to the public:
AS SOON AS PRACTICABLE AFTER THE 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, check the following box. /x/
-------------
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 THAT 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 SAID SECTION 8(A),
MAY DETERMINE.
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
<PAGE>
SUBJECT TO COMPLETION, DATED MARCH 10, 1995
PROSPECTUS
SCIOS NOVA INC.
842,120 SHARES
COMMON STOCK
------------
This Prospectus relates to 842,120 shares of Common Stock, par value $.001
(the "Common Stock"), of Scios Nova Inc. ("Scios Nova" or the "Company") which
are being offered and sold by a certain stockholder of the Company (the "Selling
Stockholder"). The Selling Stockholder, directly or through agents, broker-
dealers or underwriters, may sell the Common Stock offered hereby from time to
time on terms to be determined at the time of sale, in transactions on the
Nasdaq National Market or in privately negotiated transactions. The Selling
Stockholder and any agents, broker-dealers or underwriters that participate in
the distribution of the Common Stock may be deemed to be "underwriters" within
the meaning of the Securities Act of 1933, as amended (the "Act"), and any
commission received by them and any profit on the resale of the Common Stock
purchased by them may be deemed to be underwriting discounts or commissions
under the Act. See "Selling Stockholder" and "Plan of Distribution." The
Company will not receive any proceeds from the sale of shares by the Selling
Stockholder.
The Common Stock of the Company is quoted on the Nasdaq National Market
under the symbol "SCIO." The last reported sales price of the Company's Common
Stock on the Nasdaq National Market on March 8, 1995 was $8.50 per share.
-------------
THIS OFFERING INVOLVES A HIGH DEGREE OF RISK. SEE "RISK FACTORS."
-------------
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.
No underwriting commissions or discounts will be paid by the Company in
connection with this offering. Estimated expenses payable by the Company in
connection with this offering are $22,400, $22,105 of which are expected to be
reimbursed by the Selling Stockholder. See "Plan of Distribution." The
aggregate proceeds to the Selling Stockholder from the Common Stock will be the
purchase price of the Common Stock sold less the aggregate agents' commissions
and underwriters' discounts, if any.
The Company has agreed to indemnify the Selling Stockholder and certain
other persons against certain liabilities, including liabilities under the Act.
March , 1995
----
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.
<PAGE>
AVAILABLE INFORMATION
The Company is subject to the reporting requirements of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), and in accordance
therewith, files annual and quarterly reports, proxy statements and other
information with the Securities and Exchange Commission (the "Commission").
Such reports, proxy statements and other information may be inspected and copied
at the Commission's Public Reference Section, 450 Fifth Street, N.W., Room 1024,
Washington, D.C. 20549, as well as at the Commission's Regional Offices at 7
World Trade Center, 13th Floor, New York, New York 10048; and 500 West Madison
Street, Suite 1400, Chicago, Illinois 60661-2511. Copies of such material can
be obtained at prescribed rates from the Public Reference Section of the
Commission at 450 Fifth Street, N.W., Washington, D.C. 20549. The Common Stock
of the Company is quoted on the Nasdaq National Market. Reports and other
information concerning the Company may be inspected at the National Association
of Securities Dealers, Inc. at 1735 K Street, N.W. Washington, D.C. 20006.
ADDITIONAL INFORMATION
A registration statement on Form S-3 with respect to the Common Stock
offered hereby (the "Registration Statement") has been filed with the Commission
under the Act. This Prospectus does not contain all of the information
contained in such Registration Statement and the exhibits and schedules thereto,
certain portions of which have been omitted pursuant to the rules and
regulations of the Commission. For further information with respect to the
Company and the Common Stock offered hereby, reference is made to the
Registration Statement and the exhibits and schedules thereto. Statements
contained in this Prospectus regarding the contents of any contract or any other
documents are not necessarily complete and, in each instance, reference is
hereby made to the copy of such contract or document filed as an exhibit to the
Registration Statement. The Registration Statement, including exhibits thereto,
may be inspected without charge at the Commission's principal office in
Washington, D.C., and copies of all or any part thereof may be obtained from the
Public Reference Section, Securities and Exchange Commission, Washington, D.C.,
20549, upon payment of the prescribed fees.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents, filed or to be filed with the Commission under the
Exchange Act are hereby incorporated by reference into this Prospectus:
(i) The Company's Annual Report on Form 10-K for the fiscal year ended
December 31, 1993, including all material incorporated by reference therein;
(ii) The Company's Quarterly Report on Form 10-Q for the quarterly period
ended September 30, 1994;
(iii) The Company's Quarterly Report on Form 10-Q for the quarterly
period ended June 30, 1994;
(iv) The Company's Quarterly Report on Form 10-Q for the quarterly period
ended March 31, 1994;
(v) The Company's Current Report on Form 8-K as filed on January 23, 1995;
and
(vi) The description of the Common Stock contained in the Company's
Registration Statement on Form 8-A as filed on June 19, 1990.
All documents filed by the Company pursuant to Sections 13(a), 13(c), 14 or
15(d) of the Exchange Act after the date of this Prospectus and prior to the
termination of the offering shall be deemed to be incorporated by reference
herein and to be a part hereof from the date of filing of such documents. Any
statement contained in this Prospectus or in a document incorporated or deemed
to be incorporated by reference herein shall be deemed to be modified or
superseded for purposes of this Prospectus to the extent that a statement
contained herein or in any subsequently-filed document which also is or is
deemed to be incorporated by reference herein modifies or supersedes such
statement. Any such statement so modified or superseded shall not be deemed,
except as so modified or superseded, to constitute a part of this Prospectus.
The Company will provide without charge to each person, including any
beneficial owner, to whom this Prospectus is delivered, upon written or oral
request of such person, a copy of any and all of the documents that have been
incorporated by reference herein (not including exhibits to such documents
unless such exhibits are specifically incorporated by reference herein or into
such documents). Such request may be directed to Scios Nova Inc., Attention:
Corporate Secretary, 2450 Bayshore Parkway, Mountain View, California 94043-
1173, telephone (415) 966-1550.
2.
<PAGE>
THE COMPANY
Scios Nova is a biopharmaceutical company engaged in the discovery,
development and commercialization of novel human therapeutics. The Company
focuses its proprietary research and development efforts on products to treat
acute illnesses, primarily in the areas of cardio-renal disease and
inflammation, and seeks to collaborate with corporate partners in the
development of products to treat chronic diseases. In addition to having
capabilities in both protein-based and small-molecule drug discovery and
development, the Company has a marketing and sales organization selling third-
party products that generate cash to help fund continued development of the
Company's proprietary products, none of which to date has been developed to the
commercialization stage.
The Company directs its resources towards the development of proprietary
products that address acute illnesses, primarily in the areas of cardio-renal
disease and inflammation, where it has significant product candidates, a strong
competitive advantage and extensive technical expertise. The Company's lead
products for acute conditions are AURICULIN[REGISTERED TRADEMARK] anaritide for
the treatment of acute renal failure and NATRECOR[REGISTERED TRADEMARK] BNP for
the treatment of acute congestive heart failure. In January 1995 the Company
completed enrollment in a 500 patient Phase III clinical trial of AURICULIN
anaritide for the treatment of acute renal failure. Following analysis of the
results of this study the Company, together with Genentech, Inc., which recently
entered into a collaboration with Scios Nova for AURICULIN anaritide, will
determine the next appropriate development steps for the product. NATRECOR is
currently in Phase II clinical studies for the treatment of acute congestive
heart failure. The Company is also continuing preclinical studies of its anti-
inflammatory compounds.
Therapies for chronic conditions, such as basic fibroblast growth factor
for wound healing, insulinotropin for Type II diabetes and a treatment for
Alzheimer's disease, are being developed by corporate partners or by Scios Nova
with funding from corporate partners. Under its arrangements with corporate
partners, Scios Nova typically receives research and development funding,
payments for clinical supplies and/or milestone payments for achieving
scientific and clinical benchmarks. The Company also is entitled to royalties
on commercial sales of products and, in some cases, may receive additional
revenues from the manufacture of products.
Scios Nova's financial strategy involves careful management of its cash
through targeted investment in its acute-care pipeline, while supporting these
efforts with cash flow from its commercial operations and from corporate partner
funded projects.
Scios Nova was formed through the September 1992 merger (the "Merger") of
Scios Inc., a Delaware corporation ("Scios"), and Nova Pharmaceutical
Corporation, a Delaware corporation ("Nova"). The Merger brought together
Scios' expertise in producing recombinant proteins with Nova's expertise in
synthesizing small molecules. As a result, Scios Nova has capabilities in
molecular and cell biology, protein and medicinal chemistry, molecular modeling,
pharmacology and the bioprocessing sciences and has the tools to undertake the
rational design of small molecules based on knowledge of the associated design
targets. The Company also acquired Nova's sales force and a line of marketed
psychiatric products in the Merger.
The Company was incorporated in California in 1981 under the name
California Biotechnology, Inc. and reincorporated in Delaware in 1988. The
Company changed its name to Scios Inc. in February 1992 and to Scios Nova Inc.
in September 1992 following the Merger. The principal executive offices of the
Company are located at 2450 Bayshore Parkway, Mountain View, California 94043.
The telephone number at that location is (415) 966-1550.
RISK FACTORS
The following are the significant risk factors that should be considered
carefully in evaluating the Common Stock of Scios Nova.
NO ASSURANCE OF SUCCESSFUL AND TIMELY PRODUCT DEVELOPMENT AND APPROVAL OF
PRODUCTS UNDER DEVELOPMENT
Scios Nova focuses its product development efforts on proprietary
therapeutics for acute illnesses, principally in the areas of cardio-renal
disease and inflammation. The Company's success will depend on its ability to
achieve scientific and technological advances and to translate such advances
into reliable, commercially competitive products on a timely basis. Scios
Nova's products are at various stages of research and development and further
development and testing will be required to determine their technical
feasibility and commercial viability. Most of these products are not likely to
become commercially available, if at all, for several more years at the
earliest. The proposed development schedules for the Company's products may be
affected by a variety of factors, including technological difficulties,
proprietary technology of others, reliance on third parties for support and
changes in governmental regulation, many of which factors will not be within
3.
<PAGE>
the control of Scios Nova. Of all the Company's potential products,
AURICULIN anaritide, which is the subject of the Company's recent
collaboration with Genentech, Inc., is at the most advanced stage of
development. See "Risk Factors-Relationship with Genentech." Any delay
in the development, introduction or marketing of the Company's potential
products could result either in such products being marketed at a time when
their cost and performance characteristics would not be competitive in the
marketplace or in a shortening of their commercial lives.
DEPENDENCE ON THIRD PARTIES
The Company plans to continue the development of therapies for the
treatment of chronic conditions primarily under the sponsorship of corporate
partners. Continued funding and participation by the Company's corporate
partners under joint development and licensing agreements will depend not only
on the timely achievement of research and development objectives by the Company,
which cannot be assured, but also on each corporate partner's own financial,
competitive, marketing and strategic considerations. Scios Nova also may from
time to time enter into collaborative arrangements involving the licensing of
certain rights to its acute care therapeutics. See "Risk Factors-Relationship
with Genentech." Under several of its joint development and license agreements,
Scios Nova relies on its corporate partners to conduct preclinical and clinical
trials, to obtain regulatory approvals and to manufacture and market products.
Although the Company believes that its corporate partners will have an economic
incentive to meet their contractual responsibilities, the amount and timing of
resources devoted to these activities generally will be controlled by the
corporate partners. Suspension or termination of its joint development
agreements with certain of Scios Nova's corporate partners or the failure of
those partners to meet their contractual responsibilities could have a material
adverse effect on the Company.
It is expected that, for at least the next several years, a portion of
Scios Nova's total revenues will continue to be derived from collaborative
research agreements. Future collaborative research agreements entered into by
Scios Nova, if any, may be subject to similar risks to those described in the
preceding paragraph. The inability of Scios Nova to obtain new collaborative
research agreements or to retain those currently in effect might have a material
adverse effect on its future operations.
RELATIONSHIP WITH GENENTECH
In December 1994 the Company entered into a Collaboration Agreement (the
"Collaboration Agreement") with Genentech Inc. relating to the joint development
and commercialization of AURICULIN anaritide for use in the treatment of acute
renal failure (the "Field"). The Collaboration Agreement provides for co-
promotion of AURICULIN anaritide in the United States and Canada and gives
Genentech exclusive marketing rights in countries other than the United States
and Canada (the "Licensed Territory"). In addition to royalties on sales in the
Licensed Territory, Scios Nova is to receive a $30 million milestone payment
upon receipt of U.S. regulatory approval, and additional payments of up to $20
million upon obtaining regulatory approvals and achieving certain sales levels
in other designated markets.
The Company will bear the development costs of AURICULIN anaritide until
the receipt of regulatory approval in North America. Thereafter, all costs of
development and promotion within North America will be shared equally among the
two parties. Genentech will bear all costs for development and promotion within
the Licensed Territory.
For the reasons set forth in "Risk Factors-Government Regulation: Need for
Regulatory Approval" there can be no assurance that the Company will ever
receive the requisite regulatory approvals to market the product and to receive
the milestone payments called for by the Collaboration Agreement. In addition,
for the reasons set forth in "Risk Factors-No Assurance of Successful and Timely
Development and Approval of Products Under Development" there can be no
assurance that any product developed under the Collaboration Agreement will
generate sufficient, if any, revenue (through milestone payments, sales,
royalties, or otherwise) to offset the development and promotion costs incurred.
Genentech has the right to terminate the Collaboration Agreement within
30 days following receipt of the Phase III clinical results of AURICULIN
anaritide. In addition, if the Company does not file a New Drug Application
("NDA") for AURICULIN anaritide by December 31, 1997, or if, within 60 days of
such filing, the FDA has not accepted for review an NDA which was filed by
December 31, 1997, Genentech has the option of (i) electing to bring
NATRECOR[REGISTERED TRADEMARK] BNP or another natriuretic peptide product under
development by Scios Nova into the Collaboration Agreement for use in the Field
or (ii) terminating the Collaboration Agreement. This option could limit the
Company's ability to enter into other collaborative arrangements on NATRECOR BNP
or any other natriuretic peptide product until the earlier of the FDA's
acceptance for review of an NDA for AURICULIN anaritide or the expiration of the
above deadlines. If Genentech were to exercise its right to bring another
product into the Collaboration Agreement in place of AURICULIN anaritide, the
milestone payments due upon regulatory approval and other events would be
reduced significantly.
4.
<PAGE>
RELIANCE ON CERTAIN PRODUCTS
The Company currently markets in the United States four psychiatric
products under license from SmithKline Beecham Corporation (the "SB Products")
and co-promotes a fifth product, HALDOL[REGISTERED TRADEMARK] Decanoate
distributed by McNeil Pharmaceutical ("McNeil"). The SB Products have a well-
established reputation, but unit volume for certain products has been eroding
and can be expected to continue to erode due to competition from generic
products sold at substantially lower prices. In the past, the decrease in unit
sales has been partially offset by price increases; however, there can be no
assurance that the market will accept any additional price increases. Under its
agreement with McNeil, the Company receives quarterly payments based on total
sales of this product reaching specified levels. Although the Company believes
that SmithKline Beecham ("SB") and McNeil will have an economic incentive to
meet their respective contractual responsibilities, the amount and timing of
resources devoted to these activities generally will be controlled by such
parties. Suspension or termination of the Company's agreements with either
party or the failure of SB or McNeil to meet their contractual responsibilities
could have a material adverse effect on the Company.
CONTINUING OPERATING LOSSES
Scios Nova has had net operating losses since its inception and expects
such losses for at least several more years. As of September 30, 1994, Scios
Nova had an accumulated deficit of $257.5 million.
The ability of the Company to achieve profitability depends principally
upon the success of its product development efforts and the timing and scope of
regulatory approvals, particularly with respect to the Company's lead products,
AURICULIN anaritide and NATRECOR BNP. Other key factors include the amount of
profits generated from the Company's sale of the SB Products, HALDOL Decanoate
and any additional products co-promoted or licensed by the Company and the
development of new sources of third-party funding and other revenues to support
continuing research and development programs.
NEED FOR ADDITIONAL FUNDING
Substantial expenditures will be required to enable Scios Nova to continue
research and development activities, to conduct existing and planned clinical
trials and to manufacture and market products currently under development.
While Scios Nova believes that its net assets, together with funding from
corporate partners and interest income, will be sufficient to meet capital
requirements for at least the next 24 months, over the long term the Company
will need to arrange additional financing for the operation of its business,
including the commercialization of its products currently under development, and
will consider collaborative arrangements and additional public or private
financings, including additional equity financings. There can be no assurances
that such additional collaborative arrangements or financings can be obtained on
reasonable terms.
DEPENDENCE ON PROPRIETARY RIGHTS OF OTHERS
The manufacture and sale of any products developed by Scios Nova will
involve the use of processes, products or information the rights to certain of
which are owned by others. Although Scios Nova has obtained licenses for the
use of certain of such processes, products and information, there can be no
assurance that such licenses will not be terminated or expire during critical
periods, that Scios Nova will be able to obtain licenses or other rights which
may be important to it or, if obtained, that such licenses will be obtained on
commercially reasonable terms. If Scios Nova is unable to obtain such licenses,
it may have to develop alternatives to avoid infringing patents of others,
potentially causing increased costs and delays in product development and
introduction or precluding Scios Nova from developing, manufacturing or selling
its planned products. Some of Scios Nova's licenses provide for limited periods
of exclusivity that may be extended only with the consent of the licensor.
There can be no assurance that extensions will be granted on any or all such
licenses. This same restriction may be contained in licenses obtained in the
future. Additionally, there can be no assurance that the patents underlying any
licenses will be valid and enforceable. To the extent any products developed by
Scios Nova are based on licensed technology, royalty payments on licenses will
reduce Scios Nova's gross profit from such product sales and may render the
sales of such products uneconomical.
Scios Nova supports and collaborates in research conducted in universities
and in governmental research organizations. There can be no assurance that
Scios Nova will have or be able to acquire exclusive rights to inventions or
technical information derived from such collaborations or that disputes will not
arise as to rights in derivative or related research programs conducted by them.
5.
<PAGE>
Scios Nova receives grants and other public funding and collaborates with
governmental research organizations in connection with certain research
programs. Inventions resulting from such public funding or collaboration may be
subject to regulatory and contractual restrictions on the manner in which any
resulting inventions may be commercialized, and the government research
organization typically retains certain rights to use such inventions itself or,
under certain circumstances, to grant rights to others.
In the event of contractual breach or bankruptcy of Scios Nova, certain of
the Company's collaborative research contracts provide for transfer of
technology (including rights to practice under any patents or patent
applications) to the contract sponsors.
LIMITED MANUFACTURING EXPERIENCE
Scios Nova has concentrated its resources on product discovery and
development prior to investing substantially in manufacturing capability. To
date the Company has produced only its proprietary basic fibroblast growth
factor ("bFGF") in limited quantities sufficient for clinical trials then being
conducted on bFGF and currently relies on third parties for the manufacture of
other products including AURICULIN anaritide. Scios Nova has a production
facility which the Company believes will enable it to produce bFGF for a third
party, and potentially other products, under requirements for current Good
Manufacturing Practices ("cGMP"). However, the Company does not currently
possess the staff or facilities necessary to manufacture any product in the
commercial quantity expected to be required in the long term. Scios Nova's
strategy of building or acquiring commercial-scale manufacturing facilities or
utilizing third-party facilities only as the need arises carries with it certain
risks, as there can be no assurance that such facilities can be built, acquired
or used on commercially acceptable terms or at all or that Scios Nova will be
able to meet manufacturing quantity and quality requirements through the use of
such arrangements.
Scios Nova currently intends to obtain AURICULIN anaritide from third-party
manufacturers. In March 1994, the Company entered into a long-term agreement
for the supply of AURICULIN anaritide in bulk form, and will have fill and
finish services performed by another third party. The Company believes that it
would not be cost-effective to qualify alternate suppliers at this time.
However, an inability of either the Company's bulk or its fill and finish
manufacturer to provide material to Scios Nova on a timely basis would cause
delays in supply which could be expected to have a material adverse effect on
the Company's business.
SB manufactures the SB Products. If SB elects to discontinue manufacturing
the SB Products, the Company will either have to develop additional facilities
to manufacture independently on a large scale, procure a contract manufacturer,
or enter into another arrangement with a third party to manufacture such
products. McNeil manufactures HALDOL Decanoate.
If Scios Nova were to develop additional products with commercial
potential, it would be required to design and construct larger facilities to
manufacture such products or be dependent upon securing a third party contract
manufacturer to manufacture such products. There can be no assurance that the
Company would be able to develop such a manufacturing capability on its own or
enter into such a partnership on favorable terms or at all. In addition,
partnering arrangements could result in a lower level of income to Scios Nova
than if the Company manufactured the products entirely on its own.
LACK OF MARKETING EXPERIENCE; DEPENDENCE ON THIRD PARTIES
Scios Nova has limited experience in managing or operating a marketing
organization. Scios Nova currently has a sales force of approximately 85
representatives experienced in marketing products to the psychiatric profession.
These sales representatives work on a part-time basis marketing the SB Products
and co-promoting the McNeil product HALDOL Decanoate. To date, Scios Nova's
marketing experience has been limited to these psychiatric products. The
Company has had no experience marketing the acute care products which are the
focus of its research and development efforts.
Scios Nova's business strategy includes acquiring or licensing additional
products developed by third parties that could be sold by the Company's sales
force while the Company seeks to complete clinical trials and commercialization
of its proprietary products. There can be no assurances that such third-party
product rights will be available on terms favorable to the Company or at all, or
that the Company will be successful in commercializing its own proprietary
products.
If Scios Nova is successful in its efforts to develop additional products
for commercial sale, the commercialization of such products will require
significant financial resources as well as worldwide sales, marketing and
distribution capabilities. The Company will consider entering into additional
corporate partnerships with major pharmaceutical companies in order to provide
funds and expertise to meet these requirements. See "Risk Factors-Relationship
with Genentech." There
6.
<PAGE>
can be no assurance that the Company would be able to develop such a marketing
capability on its own or enter into such a partnership on favorable terms or at
all. In addition, partnering arrangements could result in a lower level of
income to Scios Nova than if the Company marketed the products entirely on its
own.
TECHNOLOGICAL CHANGE AND RISK OF OBSOLESCENCE; SUBSTANTIAL COMPETITION
Competition is intense in the development of biopharmaceutical products,
particularly in the development of products through the application of
biotechnology. There are numerous companies and academic research groups
throughout the world engaged in similar research and development. Some of the
Company's competitors, including some of its licensees, are working on products
similar to those being developed by Scios Nova, including products in some of
the Company's major therapeutic focus areas. Many of these companies have
substantially greater financial, marketing and human resources than Scios Nova.
With respect to AURICULIN anaritide, Scios Nova believes other companies may be
attempting to develop other forms of natriuretic peptides for indications
similar to those being pursued by the Company.
There can be no assurance that technological developments or superior
marketing capabilities possessed by competitors will not materially adversely
affect the commercial potential of the Company's products. In addition, if the
Company commences significant commercial sales of products, manufacturing
efficiency and marketing capability are likely to be significant competitive
factors. With respect to products no longer covered by patents, such as the SB
Products, Scios Nova faces competition from companies offering generic products.
The Company believes that the competitive success of the Company will be
based primarily on scientific and technological superiority, managerial
competence in identifying and pursuing opportunities, operational competence in
developing, protecting, producing and marketing products and obtaining timely
regulatory agency approvals and adequate funds. Achieving success in these areas
will depend on the Company's ability to attract and retain skilled and
experienced personnel, to develop and secure the rights to advanced proprietary
technology and to exploit commercially its technology prior to the development
of competitive products by others. Scios Nova expects that there will be
continued competition for highly qualified scientific, technical and managerial
personnel.
UNCERTAINTY OF LEGAL PROTECTION AFFORDED BY PATENTS AND PROPRIETARY RIGHTS;
POSSIBLE INFRINGEMENT OF RIGHTS OF OTHERS
Scios Nova's success will depend in large part upon its ability to protect
its proprietary products and technology under U.S. and foreign patent laws and
other intellectual property laws. Scios Nova has incurred and expects to
continue to incur, substantial costs in connection with the protection of its
intellectual property rights. The patent position of biotechnology and
pharmaceutical firms generally is highly uncertain and involves complex legal
and factual questions. Although Scios Nova believes it has strong patent
positions on certain of its products, there can be no assurance that any patent
will issue on pending applications of the Company, or that any patent issued
will afford the Company significant commercial protection against competitors
for the technology or product covered by it, or that patents will not be
infringed upon or designed around. Third parties have filed applications for,
or have been issued patents relating to, products or processes which are similar
to or competitive with certain of the Company's products or processes. Scios
Nova is incurring and expects to continue to incur substantial costs in
interference proceedings and in defending the validity or scope of its patents
or in challenging the validity or scope of competing patents. The Company is
unable to predict how the courts will resolve issues relating to the validity
and scope of such patents, and if any such patent were to be interpreted to
cover any of the Company's products and could not be licensed, circumvented or
shown to be invalid, the results of Scios Nova's future operations could be
materially and adversely affected.
Companies which have or obtain patents relating to Scios Nova's products or
processes could bring legal actions against Scios Nova and its corporate partner
claiming damages and seeking to enjoin them from manufacturing or marketing such
products. Because of such proceedings, Scios Nova could encounter delays in
product market introductions while it attempts to design around such patents or
could find that the development, manufacture or sale of Scios Nova's products
could be foreclosed. If any such action were successful, in addition to any
potential liability for damages, Scios Nova or its corporate partners could be
required to obtain a license in order to continue to manufacture or market such
products. Even if licenses were to be available, their cost might not be
commercially acceptable. If a patent were to be issued to a third party
covering products competitive with Scios Nova's products and such patent could
not be licensed, circumvented or shown to be invalid, the results of Scios
Nova's future operations could be materially adversely affected.
Scios Nova also may have to participate in interference proceedings
declared by the United States Patent and Trademark Office (the "PTO") to
determine the priority of inventions, which could result in substantial cost to
Scios Nova or in the determination that patents should be issued to a
competitor. Unfavorable outcomes in interference proceedings could result in
the need for cross-licensing agreements with competitors that could hinder or
prevent Scios Nova from
7.
<PAGE>
making, using or selling the products which are the subjects of such patents or
adversely affect Scios Nova's operating results.
Other companies engaged in research and development of new health care
products based on biotechnology also are actively pursuing patents for their
technologies, which they consider to be novel and patentable. Scios Nova also
relies and will continue to rely upon trade secrets and know-how to develop and
maintain its competitive position. There can be no assurance, however, that
others will not develop similar technology so that confidentiality agreements on
which the Company relies to protect trade secrets will be honored. To the
extent corporate partners or consultants apply technological information
independently developed by them or by others to Scios Nova projects, disputes
may arise as to the proprietary rights to such information.
GOVERNMENT REGULATION: NEED FOR REGULATORY APPROVAL
The production and marketing of the Company's proposed products and its
ongoing research and development activities are subject to extensive regulation
by numerous governmental authorities in the United States and other countries.
Prior to marketing in the United States, a drug must undergo rigorous
preclinical and clinical testing and an extensive regulatory approval process
implemented by the U.S. Food and Drug Administration ("FDA") under federal law,
including the Food, Drug and Cosmetic Act, as amended. Satisfaction of such
regulatory requirements includes satisfying the FDA that the product is both
safe and efficacious. Typically, this takes several years or more depending upon
the type, complexity and novelty of the product and the nature of the disease or
other indication to be treated and requires the expenditure of substantial
resources. Preclinical studies must be conducted in conformance with the FDA's
Good Laboratory Practice regulations. Clinical testing must meet requirements
for Institutional Review Board ("IRB") oversight and informed consent by
clinical trial subjects, as well as FDA prior review, oversight and the FDA's
Good Clinical Practice requirements. Clinical trials may require large numbers
of test subjects. Scios Nova has limited experience in conducting clinical
testing and in pursuing applications necessary to gain regulatory approvals.
Furthermore, the Company or the FDA may suspend clinical trials at any time if
either believes that the subjects participating in such trials are being exposed
to unacceptable health risks, including undesirable or unintended side effects.
Before receiving FDA approval to market a product, Scios Nova may have to
demonstrate that the product represents an improved form of treatment compared
to existing therapies. Data obtained from preclinical and clinical activities
are susceptible to varying interpretations, which could delay, limit or prevent
regulatory approvals. In addition, delays or rejections may be encountered based
upon additional government regulation from future legislation or administrative
action or changes in FDA policy during the period of product development,
clinical trials and FDA regulatory review. Delays in obtaining such approvals
could adversely affect marketing of Scios Nova's products. Delays in regulatory
approvals that may be encountered by Scios Nova's joint development partners and
licensees could adversely affect Scios Nova's ability to receive royalties or
other sales revenues. There can be no assurance that, after such time and
expenditures, regulatory approval will be obtained for any products developed by
the Company. Even after initial FDA approval has been obtained, further studies
may be required to provide additional data on safety or to gain approval for the
use of a product as a treatment for clinical indications other than those
initially targeted. Moreover, the FDA may reconsider its approval of any
product at any time and may withdraw such approval. In addition, before the
Company's products can be marketed in foreign countries, they are subject to
regulatory approval in such countries similar to that required in the United
States. Furthermore, approval may entail ongoing requirements for post-
marketing studies.
The Orphan Drug Act currently provides incentives to manufacturers to
develop and market drugs for rare diseases or conditions affecting fewer than
200,000 persons in the United States at the time of application for orphan drug
designation. A drug that receives orphan drug designation and is the first
product to receive FDA marketing approval for its product claim is entitled to a
seven-year exclusive marketing period in the United States for that product
claim. However, a drug that is considered by the FDA to be different from a
particular orphan drug is not barred from sale in the United States during the
seven-year exclusive marketing period. The Company has received from the FDA
orphan drug designation of AURICULIN anaritide in acute kidney failure. Various
amendments of the Orphan Drug Act are currently being considered by Congress,
some of which could reduce the benefits of orphan drug status to Scios Nova, if
passed.
The FDA's regulations require that any drug or formulation to be tested in
humans must be manufactured according to cGMP regulations. This has been
extended to include any drugs which will be tested for safety in animals, in
support of human testing. The cGMPs set certain minimum requirements for
procedures, record-keeping and the physical characteristics of the laboratories
used in the production of these drugs. In addition, various federal and state
laws, regulations and recommendations relating to safe working conditions,
laboratory practices, the experimental use of animals and the purchase, storage,
movement, import and export, use, and disposal of hazardous or potentially
hazardous substances, including radioactive compounds and infectious disease
agents, used in connection with the Company's research work are
8.
<PAGE>
or may be applicable to their activities. They include, among others, the
United States Atomic Energy Act, the Clean Air Act, the Clean Water Act, the
Occupational Safety and Health Act, the National Environmental Policy Act, the
Toxic Substances Control Act, and the Resource Conservation and Recovery Act,
national restrictions on technology transfer, import, export and customs
regulations, and other present and possible future federal, state or local
regulations. Scios Nova is unable to estimate the extent and impact of
regulation in the biotechnology field resulting from such future federal, state
or local legislation or administrative action.
Outside the United States, the Company's ability to market a product is
contingent upon receiving marketing authorization from the appropriate foreign
regulatory authorities. The requirements governing the conduct of clinical
trials, marketing authorization, pricing and reimbursement vary widely from
country to country. This foreign regulatory approval process includes all of the
risks associated with FDA approval set forth above.
RISK OF PRODUCT LIABILITY; USE OF HAZARDOUS MATERIALS
The testing, marketing and sale of human therapeutic products entails
significant risks. If the Company succeeds in developing products in these
areas, use of such products in trials and the sale of such products following
regulatory approval may expose the Company to liability claims allegedly
resulting from use of such products. These claims might be made directly by
consumers or others. Scios Nova currently has only limited insurance for its
clinical trials. However, there can be no assurance that Scios Nova will be
able to obtain and maintain such insurance for all of its clinical trials or
that coverage will be in sufficient amounts to protect against damages for
liability that could have a material adverse effect on Scios Nova. There can
also be no assurance that Scios Nova will be able to obtain or maintain product
liability insurance in the future on acceptable terms or in sufficient amounts
to protect the Company against damages for liability that could have a material
adverse effect on the Company. The Company's agreements with SB and McNeil
provide for certain indemnification, but there can be no assurance that any
claim arising from products manufactured by SB or McNeil would not also include
claims directly against Scios Nova.
In addition, the Company's research and development involves the controlled
use of hazardous materials, radioactive compounds and other chemicals.
Accordingly, the Company is subject to various federal, state and local
environmental laws and regulations. Failure to comply with present or future
regulations could result in substantial liability to the Company, suspension or
cessation of the Company's operations, restrictions on the Company's ability to
expand at its present location or the incurrence of other significant expense.
Although the Company believes that its safety procedures for handling and
disposing of such materials comply with the standards prescribed by federal,
state and local regulations, the risk of accidental contamination or injury from
these materials cannot be completely eliminated. In the event of such an
accident, the Company could be held liable for any damages that result and any
such liability could exceed the resources of the Company. The Company may also
incur substantial costs to comply with environmental regulations if the Company
develops additional manufacturing capacity or otherwise changes its operations.
For example, in connection with the closure of its Baltimore research and
development facility in 1994 to consolidate such activities at its Mountain View
headquarters, the Company incurred costs of approximately $370,000 for chemical
disposal, storage and related costs.
HEALTHCARE REIMBURSEMENT
Scios Nova's ability to successfully commercialize human therapeutic
products may depend in part on the extent to which reimbursement for the cost of
such products and related treatment will be available from government health
administration authorities, private health coverage insurers and other
organizations. Significant uncertainty exists as to the reimbursement status of
newly approved healthcare products, and there can be no assurance that adequate
third-party coverage will be available for Scios Nova to maintain price levels
sufficient for realization of an appropriate return on its investment in product
development. Government and other third party payers are increasingly
attempting to contain healthcare costs by limiting both coverage and the level
of reimbursement for new therapeutic products approved for marketing by the FDA
and by refusing, in some cases, to provide any coverage for uses of approved
products for disease indications for which the FDA has not granted marketing
approval. If adequate coverage and reimbursement levels are not provided by
government and third-party payers for uses of Scios Nova's healthcare products,
the market acceptance of these products would be adversely affected.
NO ASSURANCE OF ABILITY TO ATTRACT AND RETAIN KEY PERSONNEL; ABSENCE OF KEY-MAN
LIFE INSURANCE
Scios Nova's ability to maintain its competitive technological position
will depend, in part, upon its ability to attract and retain highly qualified
scientific, managerial and manufacturing personnel. Competition for such
personnel is intense. Scios Nova must recruit and organize expanded marketing
and sales organizations for those products it will commercialize
9.
<PAGE>
directly. The loss of a significant group of key personnel would adversely
affect Scios Nova's product development effort. Scios Nova does not currently
maintain key-man life insurance on any of its employees.
VOLATILITY OF STOCK PRICE AND ABSENCE OF DIVIDENDS
The market prices for securities of biotechnology and pharmaceutical
companies, including the securities of Scios Nova, have been volatile.
Announcements of technological innovations or new commercial products by Scios
Nova or its competitors, a change in status of a corporate partner, developments
concerning proprietary rights, including patents and litigation matters,
publicity regarding actual or potential medical results with products under
development by Scios Nova, regulatory developments in both the United States and
foreign countries and public concern as to the safety of biotechnology or of
pharmaceutical products, as well as period-to-period fluctuations in revenues
and financial results, may have a significant impact on the market price of its
Common Stock. Scios Nova has not paid any cash dividends since its inception,
and it does not anticipate paying cash dividends in the foreseeable future.
ANTI-TAKEOVER EFFECTS OF CERTAIN PROVISIONS OF THE COMPANY'S CERTIFICATE OF
INCORPORATION AND BYLAWS
Certain provisions of Scios Nova's Certificate of Incorporation, as
amended, Bylaws and Share Purchase Rights Plan may have the effect of delaying,
deferring or preventing attempts to acquire control of Scios Nova. The delay,
deferral or prevention of a change in control may result in denying to
stockholders of Scios Nova the receipt of a premium for their stock in the
transaction which would have resulted in the change of control and may also
result in a depressive effect on the market price of the Scios Nova Common
Stock.
10.
<PAGE>
USE OF PROCEEDS
The Company will not receive any proceeds from the sale of Common Stock by
the Selling Stockholder in the offering.
SELLING STOCKHOLDER
The following table sets forth the name of the Selling Stockholder, the
number of shares of Common Stock owned beneficially by the Selling Stockholder
as of December 31, 1994 and the number of shares which may be offered pursuant
to this Prospectus. This information is based upon information provided by the
Selling Stockholder. Because the Selling Stockholder may offer all, some or
none of its Common Stock, no definitive estimate as to the number of shares
thereof that will be held by the Selling Stockholder after such offering can be
provided.
<TABLE>
<CAPTION>
SHARES BENEFICIALLY SHARES BENEFICIALLY
OWNED PRIOR TO OWNED AFTER
OFFERING SHARES OFFERING(1)
------------------- BEING -------------------
NAME NUMBER PERCENT(2) OFFERED NUMBER PERCENT(2)
---- ------ ------- ------- ------ -------
<S> <C> <C> <C> <C> <C>
Genentech, Inc....................2,205,300 5.9% 842,120 1,363,180 3.6%
<FN>
- -----------------
(1) Assumes the sale of all shares offered hereby.
(2) Applicable percentage of ownership is based on 35,283,200 shares of Common
Stock outstanding on December 31, 1994 and assumes the issuance of 2,105,300
shares of Common Stock issuable upon conversion of 21,053 shares of the
Company's nonvoting Series A Preferred Stock.
</TABLE>
In December 1994 the Selling Stockholder entered into the Collaboration
Agreement with the Company. See "Risk Factors -- Relationship with Genentech."
At that time the Selling Stockholder also (i) purchased $20 million of nonvoting
Series A Preferred Stock of the Company convertible into 2,105,300 shares of
Common Stock and (ii) agreed to loan the Company an additional $30 million,
which the Company can draw down at its discretion through December 2002. Amounts
drawn under this loan facility will bear interest at the prime rate and be
repayable in cash or Scios Nova Common Stock, at the Company's option, in
December 2002.
11.
<PAGE>
PLAN OF DISTRIBUTION
The Company is registering the shares of Common Stock offered by the
Selling Stockholder hereunder pursuant to contractual registration rights
contained in a Preferred Stock Purchase Agreement entered into in December 1994
(the "Purchase Agreement"), pursuant to which the Selling Stockholder purchased
21,053 shares of nonvoting Series A Preferred Stock for approximately $20
million. Each share of such Preferred Stock is convertible, at the request of
the Selling Stockholder or upon transfer to a third party, into 100 shares of
the Company's Common Stock for a total of 2,105,300 shares of Common Stock. The
Selling Stockholder may not transfer ownership of any of such shares without
first offering the Company the opportunity to purchase such shares at the
average closing trading price for a period preceding the sale. If the Company
does not purchase the shares offered to it, the Selling Stockholder may sell
such shares to any third party without reoffering them to the Company.
Furthermore, the Purchase Agreement provides that the Selling Stockholder may
not, without the consent of Scios Nova, sell to a single third party investor in
any 12 month period more than 500,000 shares of Common Stock purchased under the
Purchase Agreement prior to December 31, 1996 or more than 1,000,000 shares of
Common Stock during any 12 month period thereafter (except that the foregoing
volume limitation is inapplicable to sales of the Common Stock to brokers or
dealers who agree to abide by such volume limitation). The foregoing transfer
restrictions terminate upon the earliest to occur of (i) December 30, 2002,
(ii) the date on which the Selling Stockholder and its affiliates no longer own
3% of the Company's outstanding voting securities or (iii) the closing of a
merger or similar transaction in which greater than 50% of the Company's voting
stock is transferred to a stockholder or group of stockholders, or a sale of all
or substantially all of the Company's assets.
Subject to the restrictions set forth in the Purchase Agreement, the shares
of Common Stock offered hereunder may be sold from time to time by the Selling
Stockholder, or by pledgees, donees, transferees or other successors in
interest. Such sales may be made on the Nasdaq National Market or in the over-
the-counter market or otherwise, at prices and on terms then prevailing or
related to the then-current market price, or in negotiated transactions. The
shares of Common Stock may be sold to or through one or more broker-dealers,
acting as agent or principal, in underwritten offerings, block trades, agency
placements, exchange distributions, brokerage transactions or otherwise, or in
any combination of transactions.
In connection with distributions of the Common Stock, the Selling
Stockholder may enter into hedging transactions with broker-dealers and the
broker-dealers may engage in short sales of the Common Stock in the course of
hedging the positions they assume with the Selling Stockholder. The Selling
Stockholder also may sell the Common Stock short and deliver the Common Stock to
close out such short positions. The Selling Stockholder also may enter into
option or other transactions with broker-dealers that involve the delivery of
the Common Stock to the broker-dealers, which may then resell or otherwise
transfer such Common Stock. The Selling Stockholder also may loan or pledge the
Common Stock to a broker-dealer and the broker-dealer may sell the Common Stock
so loaned or upon a default may sell or otherwise transfer the pledged Common
Stock.
In connection with any transaction involving the Common Stock, broker-
dealers or others may receive from the Selling Stockholder, and may in turn pay
to other broker-dealers or others, compensation in the form of commissions,
discounts or concessions in amounts to be negotiated at the time. Broker-
dealers and any other persons participating in a distribution of the Common
Stock may be deemed to be "underwriters" within the meaning of the Act in
connection with such distribution, and any such commissions, discounts or
concessions may be deemed to be underwriting discounts or commissions under the
Act.
Any or all of the sales or other transactions involving the Common Stock
described above, whether effected by the Selling Stockholder, any broker-dealer
or others, may be made pursuant to this prospectus. In addition, any shares of
Common Stock that qualify for sale pursuant to Rule 144 under the Act may be
sold under Rule 144 rather than pursuant to this prospectus.
In order to comply with the securities laws of certain states, if
applicable, the Common Stock may be sold in such jurisdictions only through
registered or licensed brokers or dealers. In addition, in certain states the
Common Stock may not be sold unless it has been registered or qualified for sale
or an exemption from registration or qualification requirements is available and
is complied with.
The registration fee and fees in connection with listing the Common Stock
on the Nasdaq National Market will be reimbursed by the Selling Stockholder.
The Selling Stockholder will also reimburse the Company for all
12.
<PAGE>
other costs, expenses and fees in connection with the registration of the Common
Stock with the Commission up to $20,000. The Company and the Selling
Stockholder have agreed, and hereafter may further agree, to indemnify certain
persons, including broker-dealers or others, against certain liabilities in
connection with any offering of the Common Stock, including liabilities arising
under the Act.
LEGAL MATTERS
The validity of the Common Stock offered hereby will be passed upon for the
Company by Cooley Godward Castro Huddleson & Tatum, Palo Alto, California.
EXPERTS
The financial statements and schedules appearing in the Company's Annual
Report on Form 10-K for the fiscal year ended December 31, 1993 have been
audited by Coopers & Lybrand, independent accountants, as set forth in their
report thereon included therein and incorporated herein by reference. Such
financial statements and schedules are incorporated herein by reference in
reliance upon such report given upon the authority of such firm as experts in
accounting and auditing.
No dealer, salesman or other person has been authorized to give any
information or to make any representations other than those contained in this
Prospectus, and, if given or made, such other information or representations
must not be relied upon as having been authorized by the Company. This
Prospectus does not constitute an offer or solicitation by anyone in any state
in which such offer or solicitation is not authorized, or in which the person
making such offer or solicitation is not qualified to do so, or to any person to
whom it is unlawful to make such offer or solicitation. The delivery of this
Prospectus at any time does not imply that information herein is correct as of
any time subsequent to the date hereof.
TABLE OF CONTENTS
Page
----
Available Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Additional Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Incorporation of Certain
Documents by Reference . . . . . . . . . . . . . . . . . . . . . . . . . . 2
The Company . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Use of Proceeds. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Selling Stockholder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Plan of Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Legal Matters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Experts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
-------------------
13.
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth all expenses, other than the underwriting
discounts and commissions, payable by the Registrant in connection with the sale
of the Common Stock being registered. All the amounts shown are estimates
except for the registration fee.
<TABLE>
<CAPTION>
<S> <C>
Registration fee ............................. $ 2,105
Blue sky qualification fees and expenses ..... --
Printing and engraving expenses .............. --
Legal fees and expenses ...................... 15,000
Accounting fees and expenses ................. 5,000
Miscellaneous ................................ 295
-------
Total ................................ $22,400
-------
-------
</TABLE>
ITEM 15. INDEMNIFICATION OF OFFICERS AND DIRECTORS.
The Company's Certificate of Incorporation and Bylaws include provisions to
(i) eliminate the personal liability of its directors for monetary damages
resulting from breaches of their fiduciary duty to the extent permitted by
Section 102(b)(7) of the General Corporation Law of Delaware (the "Delaware
Law") and (ii) authorize the Company to indemnify its directors and officers to
the fullest extent permitted by Section 145 of the Delaware Law, including
circumstances in which indemnification is otherwise discretionary. Pursuant to
Section 145 of the Delaware Law, a corporation generally has the power to
indemnify its present and former directors, officers, employees and agents
against expenses incurred by them in connection with any suit to which they are,
or are threatened to be made, a party by reason of their serving in such
positions so long as they acted in good faith and in a manner they reasonably
believed to be in, or not opposed to, the best interests of a corporation, and
with respect to any criminal action, they had no reasonable cause to believe
their conduct was unlawful. The Company believes that these provisions are
necessary to attract and retain qualified persons as directors and officers.
These provisions do not eliminate liability for breach of the director's duty of
loyalty to the Company or its stockholders, for acts or omissions not in good
faith or involving intentional misconduct or knowing violations of law, for any
transaction from which the director derived an improper personal benefit or for
any willful or negligent payment of any unlawful dividend or any unlawful stock
purchase agreement or redemption.
The Company has entered into agreements with its directors and executive
officers that require the Company to indemnify such persons against expenses,
judgments, fines, settlements and other amounts actually and reasonably incurred
(including expenses of a derivative action) in connection with any proceeding,
whether actual or threatened, to which any such person may be made a party by
reason of the fact that such person is or was a director or officer of the
Company or any of its listed enterprises, provided such person acted in good
faith and in a manner such person reasonably believed to be in or not opposed to
the best interests of the Company and, with respect to any criminal proceeding,
had no reasonable cause to believe his or her conduct was unlawful. The
indemnification agreements also set forth certain procedures that will apply in
the event of a claim for indemnification thereunder.
The Company has purchased an insurance policy covering the officers and
directors of the Company with respect to certain liabilities arising under the
Securities Act or otherwise.
II-1
<PAGE>
ITEM 16. EXHIBITS
(a) Exhibits.
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT
------ -----------------------
5.1* Opinion of Cooley Godward Castro Huddleson & Tatum.
23.1 Consent of Coopers & Lybrand.
23.2 Consent of Cooley Godward Castro Huddleson & Tatum.
Reference is made to Exhibit 5.1.
24.1* Power of Attorney. Reference is made to page II-3.
- ---------------------------------
*Previously filed.
ITEM 17. UNDERTAKINGS.
Insofar as indemnification for liabilities arising under the Act may be
permitted to directors, officers and controlling persons of the Company pursuant
to provisions described in Item 15, or otherwise, the Company has been advised
that in the opinion of the Commission such indemnification is against public
policy as expressed in the Act and is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other than the
payment by the Company of expenses incurred or paid by a director, officer or
controlling person of the Company 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 Company 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 Act and will
be governed by the final adjudication of such issue.
The undersigned Company hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement 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.
(2) That, for the purpose of determining any liability under the 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.
(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.
(4) That, for purposes of determining any liability under the Act, each
filing of the Company's annual report pursuant to Section 13(a) or 15(d) of the
Exchange Act (and, where applicable, each filing of an employee benefit plan's
annual report pursuant to Section 15(d) of the Exchange Act) 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.
(5) That, for purposes of determining any liability under the 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 Company pursuant to Rule 424(b)(1) or (4) or 497(h)
under the Act shall be deemed to be part of this Registration Statement as of
the time it was declared effective.
(6) 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 Exchange Act; 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.
II-2
<PAGE>
SIGNATURES
PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OF 1933, THE COMPANY HAS
DULY CAUSED THIS AMENDMENT NO. 1 TO THE REGISTRATION STATEMENT TO BE SIGNED ON
ITS BEHALF BY THE UNDERSIGNED, THEREUNTO DULY AUTHORIZED, IN THE CITY OF
MOUNTAIN VIEW, COUNTY OF SANTA CLARA, STATE OF CALIFORNIA, ON THE 10TH DAY OF
MARCH, 1995.
SCIOS NOVA INC.
By: /S/ RICHARD L. CASEY
------------------------------------------
Richard L. Casey
Chairman of the Board, President
and Chief Executive Officer
(PRINCIPAL EXECUTIVE OFFICER)
PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OF 1933, THIS AMENDMENT
NO. 1 TO THE REGISTRATION STATEMENT HAS BEEN SIGNED BELOW BY THE FOLLOWING
PERSONS IN THE CAPACITIES AND ON THE DATES INDICATED.
<TABLE>
<CAPTION>
SIGNATURE TITLE DATE
--------- ----- ----
<S> <C> <C>
/S/ RICHARD L. CASEY Chairman of the Board March 10, 1995
- -------------------------------------- President and Chief
Richard L. Casey Executive Officer
(PRINCIPAL EXECUTIVE OFFICER)
*/S/ W. VIRGINIA WALKER Vice President of Finance and March 10, 1995
- -------------------------------------- Administration and Chief
W. Virginia Walker Financial Officer
(PRINCIPAL FINANCIAL AND
ACCOUNTING OFFICER)
*/S/ MYRON DU BAIN Director March 10, 1995
- --------------------------------------
Myron Du Bain
*/S/ STEVEN D. GOLDBY Director March 10, 1995
- --------------------------------------
Steven D. Goldby
*/S/ WILLIAM F. MILLER Director March 10, 1995
- --------------------------------------
William F. Miller
*/S/ DONALD E. O'NEILL Director March 10, 1995
- --------------------------------------
Donald E. O'Neill
*/S/ ROBERT W. SCHRIER Director March 10, 1995
- --------------------------------------
Robert W. Schrier
*/S/ SOLOMON H. SNYDER Director March 10, 1995
- --------------------------------------
Solomon H. Snyder
*/S/ EUGENE L. STEP Director March 10, 1995
- --------------------------------------
Eugene L. Step
*By /S/ RICHARD L. CASEY
- --------------------------------------
Richard L. Casey
ATTORNEY-IN-FACT
</TABLE>
II-3
<PAGE>
INDEX TO EXHIBITS
EXHIBIT SEQUENTIAL
NUMBER DESCRIPTION PAGE NO.
- ------- --------------------------------------------------- ----------
5.1* Opinion of Cooley Godward Castro Huddleson & Tatum.
23.1 Consent of Coopers & Lybrand.
23.2 Consent of Cooley Godward Castro Huddleson & Tatum.
Reference is made to Exhibit 5.1
24.1* Power of Attorney. Reference is made to page II-3.
---------------------------------------------------
*Previously filed.
<PAGE>
EXHIBIT 23.1
CONSENT OF INDEPENDENT ACCOUNTANTS
We consent to the incorporation by reference in the registration statement of
Scios Nova Inc. on Form S-3 of our report dated February 1, 1994, on our
audits of the consolidated financial statements and financial statement
schedules of Scios Nova Inc. as of December 31, 1993 and 1992, and for the
years ended December 31, 1993, 1992, and 1991, which report is incorporated by
reference in the Annual Report on Form 10-K.
/s/ Coopers & Lybrand
--------------------------
COOPERS & LYBRAND
San Jose, California
March 10, 1995
