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FILING PURSUANT TO RULE 424(B)(2)
REGISTRATION STATEMENT NO. 333-70505
PROSPECTUS SUPPLEMENT
(TO PROSPECTUS DATED MAY 26, 1999)
1,000,000 SHARES
SUPERGEN, INC.
COMMON STOCK
---------------------------
You should read this prospectus supplement and the accompanying
prospectus carefully before you invest. Both documents contain information you
should consider when making your investment decision.
SEE "RISK FACTORS" BEGINNING ON PAGE 2 OF THE ACCOMPANYING PROSPECTUS
TO READ ABOUT FACTORS YOU SHOULD CONSIDER BEFORE BUYING SHARES OF THE
COMMON STOCK.
PLAN OF DISTRIBUTION
We are offering 1,000,000 shares of our common stock to one institutional
investor pursuant to this prospectus supplement. 900,000 shares of the common
stock will be purchased at a negotiated purchase price of $10.00 per share, and
100,000 shares of the common stock will be purchased at a negotiated purchase
price of $14.00 per share. We will not pay commissions or any other compensation
in conjunction with this sale of our common stock.
USE OF PROCEEDS
The net proceeds to us from this offering will be $10,400,000. We plan to
use the net proceeds for general corporate purposes, including:
- repaying our obligations as they become due;
- financing capital expenditures; and
- working capital
Pending use of the net proceeds for any of these purposes, we may invest
the net proceeds in short-term investment grade instruments, interest-bearing
bank accounts, certificates of deposit, money market securities, U.S. government
securities or mortgage-backed securities guaranteed by federal agencies.
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MARKET FOR OUR COMMON STOCK
On May 25, 1999, the last reported sales price of our common shares on
the Nasdaq National Market System was $17.38 per share. Our common stock is
listed on the Nasdaq National Market under the symbol "SUPG". The common stock
sold under this prospectus supplement will be listed on the Nasdaq National
Market after we notify Nasdaq that the shares have been issued.
As of May 25, 1999 and before the issuance of shares pursuant to this
prospectus supplement, we have 21,131,207 shares of common stock outstanding.
GENERAL
You should rely only on the information provided or incorporated by
reference in this prospectus supplement and the accompanying prospectus. We have
not authorized anyone else to provide you with different information. You should
not assume that the information in this prospectus supplement is accurate as of
any date other than the date on the front of these documents.
---------------------------
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY OTHER REGULATORY
BODY HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE
ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE
CONTRARY IS A CRIMINAL OFFENSE.
---------------------------
The date of this prospectus supplement is May 26, 1999.
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TABLE OF CONTENTS
<TABLE>
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Page
<S> <C>
PROSPECTUS SUPPLEMENT
Plan of Distribution..........................................S-1
Use of Proceeds...............................................S-1
Market for Our Common Stock...................................S-2
General.......................................................S-2
PROSPECTUS
Summary.......................................................2
Risk Factors..................................................2
Recent Developments...........................................10
Where You Can Find More Information...........................10
Note Regarding Forward-Looking Statements.....................11
Use of Proceeds...............................................11
Dividend Policy...............................................12
Plan of Distribution..........................................12
Legal Matters.................................................12
Experts.......................................................12
</TABLE>
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PROSPECTUS
$20,000,000
SUPERGEN, INC.
COMMON STOCK
This prospectus is part of the registration statement we filed with the
Securities and Exchange Commission using a "shelf" registration process. This
means:
- - We may issue up to $20,000,000 of our common stock from time to
time.
- - We will circulate a prospectus supplement each time we plan to issue our
common stock.
- - The prospectus supplement will inform you about the specific terms of that
offering and also may add, update or change information contained in this
prospectus.
- - You should read this prospectus and any prospectus supplement carefully
before you invest.
Our common stock is listed on the Nasdaq National Market under the symbol
"SUPG". On May 25, 1999, the last reported sale price for our common stock on
the Nasdaq National Market was $17.38 per share.
SEE "RISK FACTORS" BEGINNING AT PAGE 2 TO READ ABOUT FACTORS YOU SHOULD
CONSIDER BEFORE BUYING SHARES OF OUR COMMON STOCK.
-----------
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE
ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
The date of this prospectus is May 26, 1999.
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SUMMARY
We are an emerging pharmaceutical company dedicated to the acquisition,
rapid development and commercialization of products for the treatment of
life-threatening diseases, particularly cancer. We seek to minimize the time,
expense and technical risk associated with drug commercialization by
identifying, acquiring and developing pharmaceutical compounds in the later
stages of development, rather than committing significant resources to the
research phase of drug discovery.
We are focusing our existing and proposed commercialization efforts on two
drugs, Nipent(R) and RFS 2000.
We are currently marketing Nipent(R) in the United States for the treatment
of hairy cell leukemia. We are also conducting clinical trials of Nipent(R) in
order to seek FDA approval to expand its use for the treatment of additional
forms of leukemia. RFS 2000 is a drug compound in the late stage of clinical
development. Clinical studies indicate it has the potential to treat a
variety of solid tumors, including pancreatic, lung, colorectal, ovarian and
prostate cancers.
We are also developing our product line of enhanced generic anticancer
drugs using our Extra proprietary drug delivery technology. This technology,
consisting of a delivery system incorporating the active drug cyclodextrin, has
the following properties:
- - The form of a ready to inject, stable solution that increases the ease and
safety of administration.
- - Increased shelf life, facilitating multiple doses from a single vial.
- - Less susceptibility to ulceration at the injection site
due to shielding properties of the Extra
formulation. The drug is released only upon
circulation within the bloodstream.
Our Extra technology is protected by a combination of exclusive and
non-exclusive licenses and related patents. These patents were issued between
1991 and 1998. The licenses pertaining to the Extra platform generally are
effective for the terms of the related patents.
We seek to expand our portfolio of anticancer drugs through the acquisition
of products and product candidates, or companies owning such products or
candidates, which complement our portfolio and provide us with market
opportunities. In January 1999, we executed an agreement to acquire all of the
outstanding capital stock of Sparta Pharmaceuticals, Inc. for 650,000 shares
(subject to adjustment) of our common stock. The acquisition is subject to the
approval of Sparta's stockholders. See "Recent Developments" on page 10.
We also have non-oncology programs in the large market areas of anemias and
other blood cell disorders, obesity/diabetes and autoimmune diseases. We intend
to seek partnerships with larger drug companies for the development and
marketing of these non-oncology drug candidates.
Throughout this prospectus, we use the term "proprietary" to refer to some
of our products and technology. By use of this term, we mean to refer to those
products and technology that are protected from competition by patents,
licenses, manufacturing know-how or a combination of these competitive barriers.
We incorporated in March 1991 as a California corporation and changed our
state of incorporation to Delaware on November 3, 1997. Our executive offices
are located at Two Annabel Lane, Suite 220, San Ramon, California, and our
telephone number at that address is (925) 327-0200.
RISK FACTORS
YOU SHOULD CAREFULLY CONSIDER THE RISKS DESCRIBED BELOW BEFORE MAKING AN
INVESTMENT DECISION. THE RISKS AND UNCERTAINTIES DESCRIBED BELOW ARE NOT THE
ONLY ONES FACING SUPERGEN. ADDITIONAL RISKS AND UNCERTAINTIES NOT PRESENTLY
KNOWN TO US OR THAT WE CURRENTLY DEEM IMMATERIAL MAY ALSO IMPAIR OUR BUSINESS
OPERATIONS.
IF ANY OF THE FOLLOWING RISKS ACTUALLY OCCUR, OUR BUSINESS, RESULTS OF
OPERATIONS OR CASH FLOWS COULD BE ADVERSELY AFFECTED. IN THOSE CASES, THE
TRADING PRICE OF OUR COMMON STOCK COULD DECLINE, AND YOU MAY LOSE ALL OR PART OF
YOUR INVESTMENT.
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WE HAVE INCURRED LOSSES AND OUR BUSINESS WILL SUFFER IF WE FAIL TO ACHIEVE
SIGNIFICANT REVENUES OR PROFITABLE OPERATIONS
We have incurred cumulative losses of $56.0 million for the period from
inception through December 31, 1998. These losses included non-cash charges of
$7.5 million for the acquisition of in-process research and development. We have
not achieved profitability and expect to continue to incur substantial operating
losses at least through 2000. Substantially all of our revenues have come from
sales of Nipent(R), and we expect this trend to continue for some time.
Nipent(R) revenues were $2.7 million in 1998, $1.5 million in 1997 and $225,000
in 1996. All of these revenues resulted from commercial sales. Our ability to
achieve profitability will depend on our ability to develop, obtain regulatory
approval for and successfully market Nipent(R) for other indications, and bring
other proprietary products to market. Our ability to become profitable will also
depend upon a variety of other factors, including the following:
- - The price, volume and timing of sales of products.
- - The mix between Nipent(R) sales in the United States and those under a
supply agreement with Warner-Lambert Company for sales outside North
America.
- - Variations in gross margins of our products, which may be affected by sales
mix and competitive pricing pressures.
- - Regulatory approvals of new products or expanded
labeling of existing products.
- - Changes in the level of our research and development, including the timing
of any expansion of clinical trials. Clinical trials include the testing of
drug compounds upon human subjects.
- - Acquisitions of products, technology or companies.
Our long-term success will also be affected by expenses, difficulties and
delays frequently encountered in developing and commercializing new
pharmaceutical products, competition, and the burdensome regulatory environment
in which we operate. We cannot be certain that we will ever achieve significant
revenues or profitable operations.
OUR BUSINESS COULD SUFFER IF THE RESULTS OF FURTHER CLINICAL TESTING
INDICATE THAT OUR PROPOSED PRODUCTS ARE NOT SUITABLE FOR COMMERCIAL USE
Our proposed proprietary products are in the development rather than the
research stage. However, we must significantly develop all of our proposed
products before we can market them. Although we believe that the results of our
early stage clinical studies support further development of our proposed
proprietary products, the results we have obtained to date do not necessarily
indicate results of further testing, including controlled human clinical
testing. All of the potential proprietary products that we are currently
developing will require extensive clinical testing before we can submit any
regulatory application for their commercial use.
In contrast to our proposed proprietary products, Nipent(R) and our generic
version of mitomycin have been approved for commercial use and we began sales of
these drugs in 1996 and 1998, respectively.
OUR BUSINESS COULD SUFFER IF WE ARE UNABLE TO SUCCESSFULLY DEVELOP OUR
GENERIC PRODUCTS AND EXTRA PRODUCTS BASED ON GENERIC PRODUCTS BECAUSE THE
PATENTS FOR THE UNDERLYING DRUGS DO NOT EXPIRE
We plan to develop and market several generic and Extra drugs, some of
which are currently protected by one or more patents. If the existing patent
protection for these drugs is maintained or extended, it is unlikely that we
will be able to market our own generic and Extra versions of those drugs. We do
not believe it is financially prudent to proceed with substantial development
efforts for generic or Extra drugs if we do not know if or when existing patent
protection will cease.
In particular, we plan to develop and market a generic and an Extra
version of paclitaxel, as well as an Extra version of cisplatin. However, the
original patent protection for both drugs has been extended through the
issuance of new patents in the United States. The current cisplatin patent
expires in 2013 and the current use patent for paclitaxel expires in 2004.
Other companies interested in marketing generic versions of these drugs are
actively disputing the legality of these patents and we anticipate that these
legal disputes will be resolved within the next three years. If
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the patent protection for both these products is upheld, we will not proceed
with further development of these products. If the patent protection is
overturned, we plan to further develop these products and we believe we can
bring them to market within two years of a favorable patent ruling.
OUR BUSINESS WILL SUFFER IF WE FAIL TO OBTAIN ADEQUATE FUNDING IN A TIMELY
MANNER
We expect that we will need substantial additional funding. Our business,
results of operations and cash flows will be adversely affected if we fail to
obtain adequate funding in a timely manner. Our funding requirements will depend
on many factors, including:
- - The progress of our development programs.
- - The availability of additional drugs or drug candidates for acquisition by
SuperGen or to be licensed to SuperGen.
- - The availability of companies as potential
acquisition or merger candidates.
- - Revenue growth, if any.
- - The amount of cash generated, if any, by our
operations.
- - The timing and receipt of regulatory approvals.
- - The costs involved in preparing, filing, prosecuting, maintaining,
enforcing and defending patent claims and other intellectual property
rights.
- - Developments related to reimbursement matters.
- - Competing technological and market
developments.
- - The need for additional office and manufacturing
facilities to accommodate growth.
Without giving effect to the sale of any of our common stock in the
offering covered by this prospectus, we anticipate that our existing capital
resources as of the date of this prospectus will be adequate to fund operations
and capital expenditures through December 31, 1999. However, if we experience
unanticipated cash requirements during this period, we could require additional
funds much sooner. We may receive funds from the sale of equity securities,
including the sale of our common stock pursuant to this offering, or the
exercise of outstanding warrants and options to acquire common stock. However,
we cannot assure you that any of those fundings will occur, or if they occur,
that they will be on terms favorable to us. Also, the dilutive effect of those
fundings could adversely affect our results per share.
OUR BUSINESS WILL SUFFER IF WE FAIL TO OBTAIN REGULATORY APPROVALS IN A TIMELY
MANNER, IF AT ALL
We cannot assure you that we will obtain the necessary regulatory approvals
to manufacture or market our proposed products. The United States Food and Drug
Administration and comparable agencies in foreign countries impose substantial
requirements for the introduction of new pharmaceutical products through lengthy
and detailed clinical testing procedures, sampling activities and other costly
and time-consuming compliance procedures. We have obtained marketing approval
for Nipent(R) and our internally developed generic version of mitomycin and
approval of sources of bulk drugs for our Extra and generic products. However,
we have not yet received marketing approval for any of our internally developed
proprietary products. Our proprietary drugs and Extra drugs may require
substantial clinical trials and FDA review as new drugs. Our generic drugs
require both approval of the bulk source of the drug and FDA approval of their
final formulation.
We cannot predict with certainty if or when we might submit for
regulatory review those products currently under development. Once we submit
our potential products for review, we cannot assure you that the FDA or other
regulatory agencies will grant approvals for any of our pharmaceutical
products on a timely basis or at all. For example, we initially believed that
the FDA would abbreviate the approval process for our Extra products.
However, the FDA is reviewing Mito Extra, our first Extra product submission,
as a new drug. Sales of our products outside the United States will be
subject to regulatory requirements governing clinical trials and marketing
approval. These requirements vary widely from country to country and could
delay the introduction of our products in those countries.
OUR BUSINESS WILL SUFFER IF WE FAIL TO COMPLY WITH GOVERNMENTAL REGULATIONS
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If we fail to comply with regulatory requirements, we may be subject to
regulatory or judicial enforcement actions. Those actions could include product
recalls or seizures, injunctions, civil penalties, criminal prosecution,
refusals to approve new products, withdrawal of existing approvals and
potentially enhanced product liability exposure. Our research, testing,
manufacturing, labeling, distribution, marketing and advertising activities are
regulated extensively by governmental authorities in the United States and other
countries.
ASSERTING AND DEFENDING INTELLECTUAL PROPERTY RIGHTS WILL HARM OUR RESULTS OF
OPERATIONS REGARDLESS OF SUCCESS
Our business will be harmed if competitors develop substantially equivalent
proprietary information and techniques or otherwise gain access to our trade
secrets, if our trade secrets are disclosed or if we cannot effectively protect
our rights to unpatented trade secrets.
We actively seek patent protection for our proprietary products and
technologies. We have a number of United States patents and also have licenses
to or assignments of numerous issued United States patents. However, litigation
may be necessary to protect our patent position, and we cannot be certain that
we will have the required resources to pursue the necessary litigation or
otherwise to protect our patent rights. Our efforts to protect our patents may
fail. In addition to pursuing patent protection in appropriate cases, we also
rely on trade secret protection for unpatented proprietary technology. However,
trade secrets are difficult to protect.
Our proprietary products are dependent upon compliance with numerous
licenses and agreements. These licenses and agreements require us to make
royalty and other payments, reasonably exploit the underlying technology of the
applicable patents, and comply with regulatory filings. If we fail to comply
with these licenses and agreements, we could lose the underlying rights to one
or more of these potential products, which would adversely affect our business,
results of operations and cash flows.
Claims may be brought against us in the future based on patents held by
others. These persons could bring legal actions against us claiming damages and
seeking to enjoin clinical testing, manufacturing and marketing of the affected
product. If any of these actions are successful, in addition to any potential
liability for damages, we could be required to obtain a license in order to
continue to manufacture or market the affected product. We cannot assure you
whether we would prevail in any of these actions or that we could obtain any
licenses required under any of these patents on acceptable terms, if at all.
We know of no pending patent infringement suits, discussions regarding
possible patent infringements or threats of patent infringement litigation
either related to:
- - patents held by us or our licensors; or
- - our products or proposed products.
There has been, and we believe that there will continue to be, significant
litigation in the pharmaceutical industry regarding patent and other
intellectual property rights. If we become involved in any litigation, it could
consume a substantial portion of our resources, regardless of the outcome of the
litigation.
OUR BUSINESS WILL SUFFER IF WE FAIL TO COMPETE EFFECTIVELY, PARTICULARLY AGAINST
LARGER, MORE ESTABLISHED PHARMACEUTICAL COMPANIES WITH GREATER RESOURCES
Our competitors and probable competitors include, among others,
Ortho-McNeil Pharmaceutical, Amgen Inc., Gensia-Sicor, Inc., Bristol-Myers
Squibb Company and Immunex Corp. These companies have substantially greater
financial, research and development, manufacturing and marketing experience
and resources than we do and represent substantial long-term competition for
us. These companies may succeed in developing pharmaceutical products that
are more effective or less costly than any that we may develop or market.
Factors affecting competition in the pharmaceutical industry vary depending
on the extent to which the competitor is able to achieve a competitive advantage
based on proprietary technology. If we are able to establish and maintain a
significant proprietary position with respect to our proprietary products,
competition will likely depend primarily on the effectiveness of the product
and its pricing and the number, gravity and
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severity of its unwanted side effects as compared to alternative products.
Competition for generic products is based primarily on price and, to a
lesser extent, on name recognition and the reputation of the manufacturer in its
target markets. Moreover, the number of competitors offering a particular
generic product could dramatically affect price and gross margin for that
product, or an Extra product based on that generic product. We may be at a
disadvantage in competing with more established companies on the basis of price
or market reputation. In addition, a significant number of Extra products that
we are currently developing consist of, or are based upon, generic products for
which patent protection has expired or is expected to expire. Increased
competition in a particular generic market would likely lead to significant
price erosion for our generic products and Extra products based on those generic
products, which would adversely affect our sales and potential gross profit
margins.
For example, we believe that the total estimated U.S. sales for mitomycin,
bleomycin, etoposide and cisplatin, as well as other of our proposed generic
products and generic products upon which we propose to base Extra products, have
decreased in recent years due to increased competition. We also believe that
sales volumes and unit prices of these generics may continue to decrease as a
result of competitive factors, including the following:
- - The introduction of additional generics as well as
other anticancer drugs.
- - The desire of some companies to increase their
market share.
- - New formulations for these drugs and the use of
different therapies.
Extensive research and development efforts and rapid technological progress
characterize our industry. Although we believe that our proprietary position
gives us a competitive advantage with respect to our proposed non-generic drugs,
we anticipate that development will continue and discoveries by others may
render our current and potential products noncompetitive. In addition, we have
only limited experience in selling and marketing pharmaceutical products.
WE ARE DEPENDENT ON THIRD PARTIES FOR MANUFACTURING AND OUR BUSINESS MAY BE
HARMED IF THE MANUFACTURE OF OUR PRODUCTS IS INTERRUPTED OR DISCONTINUED AND
WE CANNOT OBTAIN THIRD PARTY MANUFACTURING ON ACCEPTABLE TERMS
We currently rely on vendors for manufacturing activities related to
Nipent(R) and our generic version of mitomycin. The facilities used by these
vendors have passed plant inspections required by the FDA prior to market
clearance of all pharmaceutical products. The FDA conducts these inspections to
ensure compliance with current Good Manufacturing Practices regulations enforced
by the FDA. If the facilities fail to maintain their Good Manufacturing
Practices status, or there is an interruption at any of these facilities due to
the occurrence of a fire, natural disaster, equipment failure or other
condition, we may not be able to locate other facilities that are FDA-approved
for manufacturing activities in a timely manner or on commercially acceptable
terms.
In addition, we store the majority of our Nipent(R) crude concentrate, the
unpurified, bulk form of the drug, at a single storage location. Improper
storage, fire, natural disaster, theft or other conditions at this location that
may lead to the loss or destruction of our Nipent(R) crude concentrate could
adversely affect our business, results of operations and cash flows. We are
currently negotiating a long-term agreement with the vendor that purifies our
current supply of crude concentrate to continue its purification services.
However, we cannot assure you that we will be able to finalize the agreement. If
we are not able to do so, our supply of Nipent(R) may be interrupted while we
seek to locate another facility and to have that facility approved by the FDA.
The delay could adversely affect our business, results of operations and cash
flows.
We will encounter similar issues with respect to any potential products
that the FDA clears for sale. We must establish and maintain relationships
with manufacturers to produce and package our finished pharmaceutical
products, including RFS 2000. In addition, the FDA must clear the facilities
used by these contract manufacturers. If we are unable to obtain or retain
third-party manufacturing on commercially acceptable terms or obtain
necessary FDA clearances to manufacture the products currently being
developed, we may not be able to commercialize pharmaceutical products as
planned. Our dependence upon third parties for the manufacture of
pharmaceutical products
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may adversely affect our profit margins and our ability to develop and
deliver pharmaceutical products on a timely and competitive basis.
We currently rely on foreign manufacturers for the production of bulk Extra
and generic formulations and on domestic manufacturers to supply sufficient
quantities of compounds to conduct clinical trials on proposed proprietary
products. If we are unable to contract for or obtain a sufficient supply of
potential pharmaceutical products on acceptable terms, or these supplies are
delayed or contaminated, we could experience:
- - Significant reductions in sales.
- - Delays in bringing our proposed proprietary, Extra
and generic products to market.
- - Delays in preclinical and human clinical testing
schedules.
- - Delays in submitting products for regulatory
approval and initiating new development programs.
Any of these factors could adversely affect our business, results of
operations and cash flows.
We do not currently intend to manufacture any pharmaceutical products,
although we may choose to do so in the future. If we decide to manufacture
products, we would be subject to the regulatory requirements described above. We
will also be subject to similar risks regarding delays or difficulties
encountered in manufacturing these pharmaceutical products and we will require
additional facilities and substantial additional capital. In addition, we have
only limited experience in manufacturing pharmaceutical products. We cannot
assure you that we would be able to manufacture any of these products
successfully and in a cost-effective manner.
THE LOSS OF KEY PERSONNEL, OR THE INABILITY TO ATTRACT AND RETAIN THE
ADDITIONAL, HIGHLY SKILLED PERSONNEL REQUIRED FOR THE EXPANSION OF OUR
ACTIVITIES, COULD ADVERSELY AFFECT OUR BUSINESS, RESULTS OF OPERATIONS AND CASH
FLOWS
Our success is dependent on key personnel, including Dr. Rubinfeld, our
President and Chief Executive Officer, and members of our senior management and
scientific staff. To successfully expand our operations, we will need to attract
additional, highly skilled individuals, particularly in the areas of clinical
administration, manufacturing and finance. We compete with other companies for
the services of existing and potential employees. We believe our compensation
and benefits packages are competitive for our geographical region and our
industry group. However, we may be at a disadvantage to the extent that
potential employees may favor larger, more established employers.
THE CONTINUING EFFORTS OF GOVERNMENT AND THIRD-PARTY PAYORS TO CONTAIN OR REDUCE
THE COSTS OF HEALTHCARE MAY ADVERSELY AFFECT OUR REVENUES AND PROFITABILITY
Our revenues and profitability may be affected by the continuing efforts of
governmental and third-party payors to contain or reduce the costs of health
care. We cannot predict the effect that these health care reforms may have on
our business, and it is possible that any of these reforms will adversely affect
our business. In addition, in both the United States and elsewhere, sales of
prescription pharmaceuticals are dependent in part on the availability of
reimbursement to the consumer from third-party payors, like government and
private insurance plans. Third-party payors are increasingly challenging the
prices charged for medical products and services. If our current and proposed
products are not considered cost-effective, reimbursement to the consumer may
not be available or be sufficient to allow us to sell products on a competitive
basis.
WE MAY BE SUBJECT TO PRODUCT LIABILITY LAWSUITS AND OUR INSURANCE MAY BE
INADEQUATE TO COVER DAMAGES
Clinical trials or marketing of any of our current and potential
pharmaceutical products may expose us to liability claims from the use of
these pharmaceutical products. We currently carry product liability
insurance. However, we cannot be certain that we will be able to maintain
insurance on acceptable terms for clinical and commercial activities or that
the insurance would be sufficient to cover any potential product liability
claim or recall. If we fail to have sufficient coverage, our business,
results of operations and cash flows could be adversely affected.
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IF WE ARE UNABLE TO COMPLY WITH ENVIRONMENTAL LAWS AND REGULATIONS, OUR BUSINESS
MAY BE HARMED
We are subject to federal, state and local laws and regulations governing
the use, manufacture, storage, handling and disposal of hazardous materials and
waste products. We currently maintain a supply of several hazardous materials at
our facilities. While we currently outsource our research and development
programs involving the controlled use of biohazardous materials, if in the
future we conduct these programs, we might be required to incur significant cost
to comply with environmental laws and regulations. In the event of an accident,
we could be held liable for any damages that result, and the liability could
exceed our resources.
ANTI-TAKEOVER PROVISIONS MAY PREVENT YOU FROM REALIZING A PREMIUM RETURN
Anti-takeover provisions of our certificate of incorporation and bylaws
make it more difficult for a third party to acquire us, even if doing so would
be beneficial to our stockholders. These provisions include:
- - Authorization of the issuance of up to 2,000,000
shares of our preferred stock.
- - Elimination of cumulative voting.
- - Elimination of stockholder action by written
consent.
Our bylaws establish procedures, including notice procedures, with regard
to the nomination, other than by or at the direction of our board of directors,
of candidates for election as directors or for stockholder proposals to be
submitted at stockholder meetings.
We are also subject to Section 203 of the Delaware General Corporation Law,
an anti-takeover law. In general, Section 203 of the Delaware General
Corporation Law prevents stockholders owning 15% or more of a corporation's
outstanding voting stock from engaging in business combinations with a Delaware
corporation for three years following the date those stockholders acquired 15%
or more of a corporation's outstanding voting stock. This restriction is subject
to exceptions, including the approval of the board of directors and of the
holders of at least two-thirds of the outstanding shares of voting stock not
owned by the interested stockholder.
These provisions are expected to discourage different types of coercive
takeover practices and inadequate takeover bids and to encourage persons seeking
to acquire control of SuperGen to first negotiate with us.
We believe that the benefits of increased protection of SuperGen's
potential ability to negotiate with the proponents of unfriendly or unsolicited
proposals to acquire or restructure SuperGen outweigh the disadvantages of
discouraging those proposals because, among other things, negotiation of those
proposals could result in an improvement of their terms.
BECAUSE CURRENT OFFICERS AND DIRECTORS OWN A LARGE PERCENTAGE OF OUR STOCK,
THESE STOCKHOLDERS MAY BE ABLE TO CONTROL SUPERGEN AND ALSO PREVENT
POTENTIALLY BENEFICIAL ACQUISITIONS OF SUPERGEN
As of May 25, 1999 our officers and directors beneficially owned
approximately 31% of the outstanding shares of our common stock. Beneficial
ownership includes shares of our common stock subject to options exercisable
within 60 days of May 25, 1999.
These stockholders, if acting together, may be able to elect all of our
directors, and otherwise significantly influence matters requiring approval by
our stockholders. This concentration of ownership and the lack of cumulative
voting may also delay or prevent a third party from acquiring us.
These stockholders may have interests that differ from other
stockholders of SuperGen, particularly in the context of potentially
beneficial acquisitions of SuperGen. For example, to the extent that these
stockholders are employees of SuperGen, they may be less inclined to vote for
acquisitions of SuperGen involving the termination of their employment or
diminution of their responsibilities or compensation.
THE TRADING PRICE OF YOUR STOCK MAY DECREASE DUE TO FACTORS BEYOND OUR CONTROL
The trading prices of our common stock are subject to significant
fluctuations in response to numerous factors, including:
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- - Variations in anticipated or actual results of
operations.
- - Announcements of new products or technological
innovations by competitors
- - FDA approval or rejection of pending applications.
- - Changes in earnings estimates of operational results by analysts.
- - Results of clinical trials.
Moreover, the stock market from time to time has experienced extreme price
and volume fluctuations, which have particularly affected the market prices for
emerging growth companies and which have often been unrelated to the operating
performance of these companies. These broad market fluctuations may adversely
affect the market price of our common stock.
During the past three years from the date of this prospectus, the market
price per share of our common stock has fluctuated between approximately $5.13
and $19.63.
OUR BUSINESS MAY BE HARMED IF WE BECOME SUBJECT TO SECURITIES CLASS ACTION
LITIGATION
In the past, following periods of volatility in the market price of a
company's common stock, securities class action litigation has been brought
against the issuing company. This type of litigation could be brought against us
in the future. The litigation could be expensive and divert management's
attention and resources, which could adversely affect our business and results
of operations whether or not our defense is successful. If the litigation is
determined against us, we could also be subject to significant liabilities.
WE MAY NOT EARN A FAVORABLE RETURN WITH THE PROCEEDS OF THIS OFFERING
Our management can spend the proceeds from this offering in ways with which
you may not agree. We cannot predict that the proceeds will be invested to yield
a favorable return.
THE MARKET PRICE OF OUR STOCK MAY FALL IF OTHER STOCKHOLDERS SELL THEIR STOCK
If our stockholders sell substantial amounts of our common stock in the
public market following this offering, the market price of our common stock
could fall. These sales also might make it more difficult for us to sell equity
or equity-related securities in the future at a price we deem appropriate.
As of May 25, 1999 we had 21,131,207 shares of our common stock
outstanding. Of these shares, approximately 20,502,524 shares were eligible
for sale in the public market.
THE VALUE OF YOUR STOCK MAY DECREASE IF OTHER SECURITY HOLDERS EXERCISE THEIR
OPTIONS AND WARRANTS
As of May 25, 1999 we had reserved an additional 9,939,321 shares of our
common stock for future issuance upon exercise of outstanding options and
warrants. If these securities are exercised, you may experience significant
dilution in the book value and earnings per share of your common stock. This may
cause the market price of our common stock to fall.
THE YEAR 2000 PROBLEM COULD CAUSE DISRUPTIONS OF OUR OPERATIONS
The Year 2000 issue is the result of computer software applications being
written using two rather than four digits to define a year. On January 1, 2000,
computer equipment and programs that have time sensitive software may not be
able to distinguish whether "00" means 1900 or 2000. This could result in a
system failure or miscalculations causing disruptions of operations, including,
among other things, a temporary inability to process transactions, send
invoices, or engage in similar normal business activities.
We converted to new accounting software in 1998 and that software
properly recognizes dates beyond December 31, 1999. We have determined that
no other software programs currently in use by SuperGen will require
significant modification or replacement to properly recognize dates beyond
December 31, 1999. We have initiated and maintained formal communications
with significant contract manufacturers, contract research organizations and
other vendors to determine the extent to which we are vulnerable to those
third parties' failure to remediate their own Year 2000 issues. Based upon
those communications, we believe that all significant computer software
programs utilized by third parties
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upon which we rely are either Year 2000 compliant or will be converted to
Year 2000 compliance prior to December 31, 1999.
One or more of our or our business partners' software applications may
prove to be non-Year 2000 compliant. In that case, we may experience
difficulties on and after January 1, 2000. The worst case Year 2000 scenario
envisioned by our management would involve delays in invoicing and shipping,
inventory production, and clinical trial documentation.
RECENT DEVELOPMENTS
On January 18, 1999, we entered into an agreement to acquire Sparta
Pharmaceuticals, Inc. Pursuant to the agreement, a wholly-owned subsidiary of
SuperGen will be merged into Sparta. After the merger, Sparta will operate as a
wholly-owned subsidiary of SuperGen. In the merger, we will issue 650,000 shares
of our common stock, subject to adjustment, in exchange for all of the
outstanding capital stock of Sparta. In addition, we have agreed to assume the
outstanding options and warrants to purchase Sparta capital stock. We anticipate
that the merger will be accounted for as a purchase.
We cannot assure you that the agreement to acquire Sparta will be
consummated. The consummation of the merger is contingent upon various
conditions to closing, including the:
- - Approval of the merger by the stockholders of
Sparta.
- - Absence of material adverse effect on SuperGen or
Sparta.
- - Accuracy of representations and warranties of
SuperGen and Sparta.
- - Performance of covenants and obligations of
SuperGen and Sparta.
- - Absence of restraining order, injunctions and other governmental order
preventing the consummation of the merger.
If all the conditions to closing are satisfied the merger is anticipated to
close during the summer of 1999.
Sparta is a development stage pharmaceutical company engaged in the
business of acquiring rights to, and developing for commercialization,
technologies and drugs for the treatment of a number of life threatening
diseases including cancer, cardiovascular disorders and inflammation.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and other
information with the SEC. Our filings are available to the public over the
internet at the SEC's web site at http://www.sec.gov. You may also read and copy
any document we file at the SEC's Public Reference Rooms in Washington, D.C.,
New York, New York and Chicago, Illinois. The Public Reference Room in
Washington D.C. is located at 450 Fifth Street, N.W. Please call the SEC at
1-800-SEC-0330 for further information on the Public Reference Rooms.
The SEC allows us to "incorporate by reference" the information we file
with it, which means that we can disclose important information to you by
referring you to those documents. The information incorporated by reference is
an important part of this prospectus, and information that we file later with
the SEC will automatically update and supersede this information. We incorporate
by reference the documents listed below and any future filings made with the SEC
under Sections 13(a), 13(c), 14, or 15(d) of the Securities Exchange Act of 1934
until we sell all of our common stock registered under this prospectus:
- - Annual Report on Form 10-K for the fiscal year ended December 31, 1998.
- - Amendment No. 1 to Annual Report on Form 10-K for the fiscal year ended
December 31, 1998.
- - Quarterly Report on Form 10-Q for the quarter ended March 31, 1999.
- - Proxy Statement for the 1999 Annual Meeting of Stockholders.
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- - The description of our common stock contained in our registration statement
on Form 8-A, filed on January 18, 1996, including any amendment or report
filed for the purpose of updating the description.
- - Current Report on Form 8-K filed with the SEC on
January 28, 1999.
- - All other reports filed pursuant to Section 13(a) or 15(d) of the
Securities Exchange Act of 1934 since December 31, 1998.
We have also filed a registration statement on Form S-3 with the SEC under
the Securities Act of 1933. This prospectus does not contain all of the
information set forth in the registration statement. You should read the
registration statement for further information about SuperGen and our common
stock. You may request a copy of these filings at no cost. Please direct your
requests to:
SuperGen, Inc.
Two Annabel Lane, Suite 220
San Ramon, California 94583
Attn: Investor Relations
(925) 327-0200
You should rely only on the information incorporated by reference or
provided in this prospectus or any prospectus supplement. We have not authorized
anyone else to provide you with different information. We are not making an
offer of our common stock in any state where the offer is not permitted. You
should not assume that the information in this prospectus or any prospectus
supplement is accurate as of any date other than the date on the front page of
those documents.
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Forward-looking statements deal with our current plans,
intentions, beliefs and expectations and statements of future economic
performance. Statements containing terms like "believes," "does not believe,"
"plans," "expects," "intends," "estimates," "anticipates" and other phrases of
similar meaning are considered to imply uncertainty and are forward-looking
statements.
Forward-looking statements involve known and unknown risks and
uncertainties which may cause our actual results in future periods to differ
materially from what is currently anticipated. We make cautionary statements
throughout this prospectus, including under "Risk Factors." You should read
these cautionary statements as being applicable to all related forwardlooking
statements wherever they appear in:
- - This prospectus.
- - The materials referred to in this prospectus.
- - The materials incorporated by reference into this prospectus, other than
forward-looking statements which do not comply with the "plain English"
requirements of Rule 421 under the Securities Act of 1933.
- - Our press releases.
No forward-looking statement is a guarantee of future performance and you
should not place undue reliance on any forward-looking statement.
USE OF PROCEEDS
Each time we sell our common stock, we will provide a prospectus supplement
that will contain information about how we intend to use the net proceeds from
our common stock sold at that time.
Unless otherwise indicated in the applicable prospectus supplement, we
plan to use the net proceeds from the sale of our common stock for general
corporate purposes, including capital expenditures and to meet working
capital needs. We expect from time to time to evaluate the acquisition of
businesses and products for which a portion of the net proceeds may be used.
Pending these uses, we will invest the net proceeds in interest-bearing
securities.
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DIVIDEND POLICY
We have not declared or paid cash dividends on our common stock. We
currently intend to retain all future earnings to fund the operation of our
business and, therefore, we do not anticipate paying dividends in the
foreseeable future. Future cash dividends, if any, will be determined by our
board of directors.
PLAN OF DISTRIBUTION
We may offer our common stock:
- - Directly to purchasers.
- - To or through underwriters.
- - Through dealers or agents.
- - Through a combination of these methods.
Regardless of the method used to sell our common stock, we will provide a
prospectus supplement that will disclose the:
- - Identity of any underwriters, dealers, agents or institutional investors
who purchase our common stock.
- - Material terms of the distribution, including the number of shares sold and
the consideration paid.
- - Amount of any compensation, discounts or commissions to be received by any
underwriters, dealers or agents.
- - Terms of any indemnification provisions, including indemnification from
liabilities under the federal securities laws.
- - Nature of any transaction by any underwriter, dealer or agent during the
offering that is intended to stabilize or maintain the market price of our
common stock.
LEGAL MATTERS
The validity of the issuance of our common stock will be passed upon for
SuperGen by Wilson Sonsini Goodrich & Rosati, P.C., Palo Alto, California.
EXPERTS
Ernst & Young LLP, independent auditors, have audited our consolidated
financial statements included in our Annual Report on Form 10-K for the year
ended December 31, 1998, as set forth in their report, which is incorporated by
reference in this prospectus and elsewhere in the registration statement. Our
financial statements are incorporated by reference in reliance on Ernst & Young
LLP's report given on their authority as experts in accounting and auditing.
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WE HAVE NOT AUTHORIZED ANY DEALER, SALESPERSON OR ANY OTHER PERSON TO GIVE
ANY INFORMATION OR TO REPRESENT ANYTHING NOT CONTAINED IN THIS PROSPECTUS. YOU
MUST NOT RELY ON ANY UNAUTHORIZED INFORMATION. THIS PROSPECTUS DOES NOT OFFER TO
SELL OR SEEK AN OFFER TO BUY ANY SHARES IN ANY JURISDICTION WHERE IT IS
UNLAWFUL. THE INFORMATION CONTAINED IN THIS PROSPECTUS IS CORRECT ONLY AS OF THE
DATE OF THIS PROSPECTUS, REGARDLESS OF THE TIME OF THE DELIVERY OF THIS
PROSPECTUS OR ANY SALE OF THE SHARES.
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$20,000,000
SUPERGEN, INC.
Common Stock
-----------
PROSPECTUS
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May 26, 1999
TABLE OF CONTENTS
Page
Summary.............................................. 2
Risk Factors......................................... 2
Recent Developments.................................. 10
Where You Can Find More Information.................. 10
Note Regarding Forward-Looking Statements............ 11
Use of Proceeds...................................... 11
Dividend Policy...................................... 12
Plan of Distribution................................. 12
Legal Matters........................................ 12
Experts.............................................. 12
13
