As filed with the Securities and Exchange Commission on July 3, 2003
Registration Statement No. 333-______________
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
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FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
CYTOGEN CORPORATION
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(Exact Name of Registrant as Specified in Its Charter)
Delaware 22-2322400
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(State or Other Jurisdiction (I.R.S. Employer
of Incorporation or Organization) Identification Number)
650 College Road East, 3rd Floor
Princeton, New Jersey 08540
(609) 750-8200
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(Address, Including Zip Code, and Telephone Number, Including
Area Code, of Registrant's Principal Executive Offices)
Donald L. Novajosky, Esq.
Director, Legal Services
Cytogen Corporation
650 College Road East, 3rd Floor
Princeton, New Jersey 08540
(609) 750-8222
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(Name, Address, Including Zip Code, and Telephone Number,
Including Area Code, of Agent for Service)
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Copy to:
Richard S. Mattessich, Esq.
Hale and Dorr LLP
650 College Road East, 4th Floor
Princeton, New Jersey 08540
(609) 750-7600
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Approximate date of commencement of proposed sale to public: As soon as
practicable after this Registration Statement becomes effective.
If the only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check the
following box. [ ]
If any of the securities being registered on this Form are to be offered
on a delayed or continuous basis pursuant to Rule 415 under the Securities Act
of 1933, other than securities offered only in connection with dividend or
interest reinvestment plans, check the following box. [X]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following
box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. _______.
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. __________.
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [ ]
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CALCULATION OF REGISTRATION FEE
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Proposed Proposed
Maximum Maximum
Amount Aggregate Aggregate Amount Of
To Be Price Offering Registration
Title Of Shares To Be Registered Registered Per Unit(1) Price(1) Fee
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Common stock,
$.01 par value per share................... 1,368,422 $7.43 $10,167,375 $822.54
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(1) Estimated solely for purposes of calculating the registration fee
pursuant to Rule 457(c) under the Securities Act of 1933, as amended,
and based upon the average of the high and low prices on the Nasdaq
National Market on June 26, 2003.
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The Company hereby amends this registration statement on such date or dates as
may be necessary to delay its effective date until the Company shall file a
further amendment which specifically states that this registration statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until the registration statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a),
shall determine.
The information in this prospectus is not complete and may be changed. The
selling stockholders named in this prospectus may not sell these securities
until the registration statement filed with the Securities and Exchange
Commission is effective. This prospectus is not an offer to sell these
securities and the selling stockholders are not soliciting offers to buy these
securities in any jurisdiction where the offer or sale is not permitted.
Subject to completion, dated July 3, 2003
PROSPECTUS
CYTOGEN CORPORATION
1,368,422 Shares of common stock
This prospectus relates to resales of shares of up to 1,368,422 shares
of our common stock, $0.01 par value per share, by certain institutional
investors set forth in this prospectus under the section titled "Selling
Stockholders". Of the 1,368,422 shares of common stock, 1,052,632 have already
been issued to the institutional investors and 315,790 shares are issuable to
such investors upon the exercise of warrants with an exercise price of $6.91 per
share. The shares of common stock and the warrants were issued to the
institutional investors pursuant to a Securities Purchase Agreement dated June
6, 2003.
We will not receive any proceeds from the sale of the shares hereunder.
The selling stockholders identified in this prospectus, or their
pledgees, assignees and successors-in-interest, may offer the shares from time
to time through public or private transactions at prevailing market prices, at
prices related to prevailing market prices or at privately negotiated prices.
On October 25, 2002, we received approval from our stockholders at a
duly called and held special meeting of stockholders to effect a reverse split
of our common stock. Our Board of Directors thereafter approved a one-for-ten
reverse split of our outstanding, issued and authorized shares of common stock,
which became effective on October 25, 2002. All numbers set forth in this
Registration Statement on Form S-3 reflect the effect of such one-for-ten
reverse stock split.
Our common stock is traded on the Nasdaq National Market under the
symbol "CYTO." On June 25, 2003, the closing sale price of our common stock on
Nasdaq was $7.09 per share. You are urged to obtain current market quotations
for our common stock.
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Investing in our common stock involves a high degree of risk. See "Risk
Factors" commencing on page 4.
-----------------------
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or determined if this
prospectus is truthful or complete. Any representation to the contrary is a
criminal offense.
The date of this prospectus is [ ], 2003.
TABLE OF CONTENTS
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Prospectus Summary............................................................................... 2
Cytogen Corporation.............................................................................. 2
The Offering..................................................................................... 2
Recent Developments.............................................................................. 3
Risk Factors..................................................................................... 4
We Have A History Of Operating Losses And An Accumulated Deficit And
Expect To Incur Losses In The Future...................................................... 4
We Are Heavily Dependent On Market Acceptance Of ProstaScint and
Quadramet For Near-Term Revenues.......................................................... 4
The Reduced Workforce At AxCell May Not Be Able To Implement AxCell's
Business Plan............................................................................. 5
We May Need To Raise Additional Capital, Which May Not Be Available........................ 6
Our Products, Generally, Are In The Early Stages Of Development And
Commercialization And We May Never Achieve The Revenue Goals Set Forth
In Our Business Plan...................................................................... 6
Our PSMA Product Development Program Is Novel And, Consequently,
Inherently Risky.......................................................................... 7
All of Our Potential Oncology Products Will Be Subject To The Risks Of Failure
Inherent In The Development Of Diagnostic Or Therapeutic Products Based On
New Technologies.......................................................................... 8
Competition In Our Field Is Intense And Likely To Increase................................. 8
We Rely Heavily On Our Collaborative Partners.............................................. 9
Our Business Could Be Harmed If Our Collaborative Arrangements Expire Or
Are Terminated Early...................................................................... 10
The Termination Of One Or More License Agreements That Are Important In The
Manufacture Of Our Current Products And New Product Research And
Development Activities Would Harm Our Business............................................ 10
We Have Limited Sales, Marketing And Distribution Capabilities For Our Products............ 10
There Are Risks Associated With The Manufacture And Supply Of Our Products................. 11
Failure Of Consumers To Obtain Adequate Reimbursement From Third-Party
Payors Could Limit Market Acceptance And Affect Pricing Of Our Products................... 11
If We Are Unable To Comply With Applicable Governmental Regulation We
May Not Be Able To Continue Our Operations................................................ 12
We Could Be Negatively Impacted By Future Interpretation Or Implementation
Of Federal And State Fraud And Abuse Laws, Including Anti-Kickback Laws,
The Federal Stark Law And Other Federal And State Anti-referral Laws..................... 13
We Depend On Attracting And Retaining Key Personnel........................................ 14
Our Business Exposes Us To Potential Liability Claims That May Exceed Our
Financial Resources, Including Our Insurance Coverage, And May Lead To The
Curtailment Or Termination Of Our Operations.............................................. 14
Our Business Involves Environmental Risks That May Result In Liability..................... 15
Our Intellectual Property Is Difficult To Protect.......................................... 15
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TABLE OF CONTENTS
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We Cannot Be Certain That Our Security Measures Protect Our Unpatented
Proprietary Technology.................................................................... 16
We Are Currently Subject To Patent Litigation.............................................. 16
Our Stock Price Has Been And May Continue To Be Volatile, And Your
Investment In Our Stock Could Decline In Value Or Fluctuate Significantly................. 16
We Have Adopted Various Anti-Takeover Provisions Which May Affect The
Market Price Of Our Common Stock.......................................................... 17
The Liquidity Of Our Common Stock Could Be Adversely Affected If We Are
Delisted From The Nasdaq National Market.................................................. 18
A Large Number Of Our Shares Are Eligible For Future Sale Which May
Adversely Impact The Market Price Of Our Common Stock..................................... 19
Because We Do Not Intend to Pay Any Cash Dividends On Our Shares of
Common Stock, Our Stockholders Will Not Be Able to Receive a Return on
Their Shares Unless They Sell Them........................................................ 20
Special Note Regarding Forward-Looking Statements................................................ 20
Use of Proceeds.................................................................................. 21
Selling Stockholders............................................................................. 22
Plan of Distribution............................................................................. 23
Legal Matters.................................................................................... 24
Where You Can Find More Information.............................................................. 24
Information Incorporated By Reference............................................................ 24
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We have not authorized anyone to provide you with information different
from that contained or incorporated by reference in this prospectus. The selling
stockholders are offering to sell, and seeking offers to buy, shares of our
common stock only in jurisdictions where offers and sales are permitted. The
information contained in this prospectus is accurate only as of the date of this
prospectus, regardless of the time of delivery of this prospectus or of any sale
of common stock.
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PROSPECTUS SUMMARY
This summary highlights important features of this offering and the information
included or incorporated by reference in this prospectus. This summary does not
contain all of the information that you should consider before investing in our
common stock. You should read the entire prospectus carefully, especially the
risks of investing in our common stock discussed under "Risk Factors."
CYTOGEN CORPORATION
Cytogen Corporation is a product-driven, oncology-focused
biopharmaceutical company with an established and growing product line in
prostate cancer and other areas of oncology. Our FDA-approved products include
ProstaScint(R) (a monoclonal antibody-based imaging agent used to image the
extent and spread of prostate cancer); Quadramet(R) (a therapeutic agent
marketed for the relief of bone pain in prostate and other types of cancer) and
NMP22 BladderChek(TM) (a point-of-care, in vitro diagnostic test for bladder
cancer). Our pipeline comprises of product candidates at various stages of
clinical development, including fully human monoclonal antibodies and cancer
vaccines based on PSMA prostate specific membrane antigen technology, or PSMA
technologies, which we exclusively licensed from Memorial Sloan-Kettering Cancer
Center. We also conduct research in cellular signaling through our subsidiary,
AxCell Biosciences.
In addition to the products listed above, in August, 2000, we expanded
our product pipeline by entering into marketing, license and supply agreements
with Advanced Magnetics, Inc. for Combidex(R), which is an investigational
magnetic resonance imaging (MRI) contrast agent that assists in the
differentiation of metastatic from non-metastatic lymph nodes. We hold exclusive
United States marketing rights to Combidex. Advanced Magnetics is continuing its
discussions with the FDA relating to outstanding issues regarding an approvable
letter received from the FDA in June, 2000, in an effort to bring Combidex to
market.
We are a Delaware corporation. We were incorporated and began
operations in 1980 under the name Hybridex, Inc. and changed our name to Cytogen
Corporation in April 1980. Our executive offices are located at 650 College Road
East, 3rd Floor, Princeton, New Jersey 08540, our telephone number is (609)
750-8200 and our Internet address is http://www.cytogen.com The information on
our Internet website is not incorporated by reference in this prospectus. Unless
the context otherwise requires references in this prospectus to "Cytogen", the
"Company," "we," "us," and "our" refer to Cytogen Corporation and our
subsidiaries.
ProstaScint(R) and OncoScint(R) are registered United States trademarks
of Cytogen Corporation. All other trade names, trademarks or servicemarks
appearing in this Registration Statement on Form S-3 are the property of their
respective owners, and not the property of Cytogen Corporation or any of our
subsidiaries. Quadramet(R) is a trademark of The Dow Chemical Company used under
license by Cytogen.
THE OFFERING
Common Stock offered by selling
stockholders................................... 1,368,422 shares
Use of proceeds................................ Cytogen will not receive any proceeds from
the sale of shares in this offering
Nasdaq National Market symbol.................. CYTO
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RECENT DEVELOPMENTS
On June 6, 2003, we sold to the selling stockholders listed in this
prospectus, 1,052,632 shares of our common stock and warrants to purchase an
additional 315,790 shares of our common stock for aggregate gross proceeds of
$5.0 million before transaction costs.
On June 10, 2003, our stockholders approved an amendment to our 1995
Stock Option Plan to increase the maximum aggregate number of shares of Common
Stock available for issuance thereunder from 450,263 to 650,263 and to reserve
an additional 200,000 shares of our Common Stock for issuance in connection with
such increase.
On June 16, 2003, we announced that we entered into an agreement with
Berlex Labratories, a U.S. affiliate of Schering AG, Germany, whereby marketing
rights held by Berlex to market Quadramet (Samarium Sm 153 Lexidronam), a
skeletal targeting therapeutic radiapharmaceutical for the relief of bone pain
in prostate and other types of cancer, in North America and South America are to
be returned to us in exchange for an upfront payment and royalties based on
future sales. The transaction, which is targeted for completion within 90 days
of entering the agreement, and is subject to our obtaining any necessary
financing for the reacquisition.
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RISK FACTORS
Investing in our common stock involves a high degree of risk. You
should carefully consider the risks and uncertainties described below before
purchasing our common stock. The risks and uncertainties described below are not
the only ones facing our company. Additional risks and uncertainties may also
impair our business operations. If any of the following risks actually occur,
our business, financial condition or results of operations would likely suffer.
In that case, the trading price of our common stock could fall, and you may lose
all or part of the money you paid to buy our common stock.
We Have a History of Operating Losses and an Accumulated Deficit and Expect To
Incur Losses in the Future.
We have a history of operating losses since our inception. We had a net loss of
$2.0 million for the three months ended March 31, 2003 and had a net loss of
$15.7 million for the year ended December 31, 2002. Beginning in December 2001,
we began to equally share the costs of the PSMA Development Company LLC and we
expect to incur significant and increasing costs in the future to fund our share
of the joint venture. We had a net loss of $12.1 million for the year ended
December 31, 2001. We had a net loss of $27.3 million for the year ended
December 31, 2000 which included non-cash charges of $13.1 million for the
acquisition of product candidate rights and $4.3 million for the cumulative
effect of an accounting change following the adoption of Securities and Exchange
Commission Staff Accounting Bulletin No. 101. We had an accumulated deficit of
$358.3 million as of March 31, 2003.
In order to develop and commercialize our technologies, particularly our
prostate specific membrane antigen, or PSMA, technology, and expand our oncology
products, we expect to incur significant increases in our expenses over the next
several years. As a result, we will need to generate significant additional
revenue to become profitable.
Our ability to generate and sustain significant additional revenues or achieve
profitability will depend upon the factors discussed elsewhere in this
"Additional Factors That May Affect Future Results" Section, as well as numerous
other factors outside of our control, including:
- development of competing products that are more effective or less
costly than ours;
- our ability to develop and commercialize our own products and
technologies; and
- our ability to achieve increased sales for our existing products and
sales for any new products.
As a result, we may never be able to generate or sustain significant additional
revenue or achieve profitability.
We Are Heavily Dependent On Market Acceptance Of ProstaScint and Quadramet For
Near-Term Revenues.
We expect ProstaScint and Quadramet to account for a significant percentage of
our product-related revenues in the near future. For the year ended December 31,
2002, revenues from ProstaScint and Quadramet accounted for approximately 78% of
our product related revenues and in the three-months ended March 31, 2003,
revenues from ProtaScint and Quadramet accounted for approximately 89% of our
product related revenues. In 2002, our product-related revenue included revenue
from BrachySeed, which accounted for 20% of our product related revenue. In
January 2003, we served notice of termination for each of our License and
Distribution Agreement and Product Manufacturing and Supply Agreement with
Draximage with respect to both the BrachySeed I-125 and BrachySeed Pd-103
products. As a result, effective January 24, 2003, we no longer accept or fill
new orders for the BrachySeed products. In April 2003, we entered into an
agreement with Draximage formally terminating each of these agreements.
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Because our marketed products contribute the majority of our product-related
revenues, our business, financial condition and results of operations depend on
their acceptance as safe, effective and cost-efficient alternatives to other
available treatment and diagnostic protocols by the medical community,
including:
- health care providers, such as hospitals and physicians; and
- third-party payors, including Medicare, Medicaid, private insurance
carriers and health maintenance organizations.
Our customers, including technologists and physicians, must successfully
complete our Partners in Excellence Program, or PIE Program, a proprietary
training program designed to promote the correct acquisition and interpretation
of ProstaScint images. This product is technique dependent and requires a
learning commitment on the part of users. We cannot assure you that additional
technologists and physicians will make this commitment or otherwise accept this
product as part of their treatment practices.
Currently, Berlex Laboratories, Inc. markets Quadramet in the United States
through an agreement with us entered into in October 1998. On June 16, 2003,
however, we entered into an agreement with Berlex whereby marketing rights held
by Berlex to market Quadramet in North America and South Ameirca are to be
returned to us in exchange for an up front payment and royalties based on future
sales. The reacquisition of the marketing rights to Quadramet is anticipated to
close within 90 days from June 16, 2003, subject to our obtaining the necessary
financing for the upfront payment to Berlex for such reacquisition. We cannot
assure you that we will be able to obtain the necessary financing to reacquire
the marketing rights to Quadramet from Berlex. If we do reacquire the marketing
rights to Quadramet, we cannot assure you that that we will be able to
successfully market Quadramet or that the agreement will result in further
revenue for us in the future. Currently, we intend to market Quadramet only in
the United States. Sales of Quadramet outside of the United States would require
certain regulatory approvals and arrangements with third party marketing
partners and we cannot assume that we would be able to obtain such approvals or
enter into such arrangements in the future.
We cannot assure you that ProstaScint or Quadramet will achieve additional
market acceptance on a timely basis, or at all. If ProstaScint or Quadramet do
not achieve broader market acceptance, we may not be able to generate sufficient
revenue to become profitable.
The Reduced Workforce At AxCell May Not Be Able To Implement AxCell's Business
Plan.
In September 2002, we implemented the restructuring of our subsidiary, AxCell
Biosciences Corporation, in an effort to reduce expenses and position Cytogen
for stronger long-term growth in oncology. As a result, we reduced our staff at
AxCell by seventy-five percent, suspended certain projects at AxCell and
implemented other cost-saving measures.
The technologies under development at AxCell are complex and remain commercially
unproven. Even if we are able to develop and commercialize a product through
AxCell, there are a limited number of pharmaceutical companies and biotechnology
companies that are potential customers for such technology or product.
Although we believe that we have retained the AxCell personnel who are key to
achieving AxCell's goals and implementing its strategies, we cannot be certain
that such reduced workforce will be able to implement AxCell's current business
plan. The further loss of any of AxCell's personnel could have a material
adverse effect on AxCell's ability to achieve its goals.
-5-
We May Need To Raise Additional Capital, Which May Not Be Available.
We have incurred negative cash flows from operations since inception. We
expended, and will need to continue to expend, substantial funds to complete our
planned product development efforts, including our PSMA programs. Our future
capital requirements and the adequacy of our available funds depend on many
factors, including:
- successful commercialization of our products;
- acquisition of complementary products and technologies;
- magnitude, scope and results of our product development efforts;
- progress of preclinical studies and clinical trials;
- progress toward regulatory approval for our products;
- costs of filing, prosecuting, defending and enforcing patent claims
and other intellectual property rights;
- competing technological and market developments; and
- expansion of strategic alliances for the sale, marketing and
distribution of our products.
We may raise additional capital through public or private equity offerings, debt
financings or additional collaborations and licensing arrangements. Additional
financing may not be available to us when needed, or, if available, we may not
be able to obtain financing on terms favorable to our stockholders or us. If we
raise additional capital by issuing equity securities, the issuance will result
in ownership dilution to our stockholders. If we raise additional funds through
collaborations and licensing arrangements, we may be required to relinquish
rights to certain of our technologies or product candidates or to grant licenses
on unfavorable terms. If we relinquish rights or grant licenses on unfavorable
terms, we may not be able to develop or market products in a manner that is
profitable to us. If adequate funds are not available, we may not be able to
conduct research activities, preclinical studies, clinical trials or other
activities relating to the successful commercialization of our products on a
timely basis, if at all, with the result that our business could be
significantly and adversely affected.
Our Products, Generally, Are In The Early Stages Of Development And
Commercialization And We May Never Achieve The Revenue Goals Set Forth In Our
Business Plan.
We began operations in 1980 and have been engaged primarily in research directed
toward the development, commercialization and marketing of products to improve
diagnosis and treatment of cancer and other diseases. In October 1996, we
introduced for commercial use our ProstaScint imaging agent. In March 1997, we
introduced for commercial use our Quadramet therapeutic product. In 2001, we
launched the iodine version of BrachySeed. In May 2002, we launched the
palladium version of BrachySeed. In November 2002, we began promoting NMP22
BladderChek to urologists in the United States. In January 2003, we discontinued
our marketing and sale of the BrachySeed products.
Our PSMA technologies are still in the early stages of development. We have
significantly reduced operations at our AxCell subsidiary, which is responsible
for the development certain of our technologies. We may be unable to develop or
commercialize these products and technologies.
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Our business is therefore subject to the risks inherent in the development of an
early stage biopharmaceutical business enterprise, such as the need:
- to obtain sufficient capital to support the expenses of developing our
technology and commercializing our products;
- to ensure that our products are safe and effective;
- to obtain regulatory approval for the use and sale of our products;
- to manufacture our products in sufficient quantities and at a
reasonable cost;
- to develop a sufficient market for our products; and
- to attract and retain qualified management, sales, technical and
scientific staff.
The problems frequently encountered using new technologies and operating in a
competitive environment also may affect our business. If we fail to properly
address these risks and attain our business objectives, our business could be
significantly and adversely affected.
Our PSMA Product Development Program Is Novel And, Consequently, Inherently
Risky.
We are subject to the risks of failure inherent in the development of product
candidates based on new technologies, including our PSMA technology. These risks
include the possibility that:
- the technologies we use will not be effective;
- our product candidates will be unsafe;
- our product candidates will fail to receive the necessary regulatory
approvals;
- the product candidates will be hard to manufacture on a large scale or
will be uneconomical to market; and
- we will not successfully overcome technological challenges presented
by our potential new products.
Our other research and development programs involve similarly novel approaches
to human therapeutics. Consequently, there is no precedent for the successful
commercialization of therapeutic products based on our PSMA technologies. We
cannot assure you that any products will be successfully developed from our PSMA
technology. If we fail to develop such products for the reasons set forth above
or for any other reason, our business could be significantly and adversely
affected.
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All of Our Potential Oncology Products Will Be Subject To The Risks Of Failure
Inherent In The Development Of Diagnostic Or Therapeutic Products Based On New
Technologies.
Product development for cancer treatment involves a high degree of risk. We
cannot assure you that the product candidates we develop, pursue or offer will
prove to be safe and effective, will receive the necessary regulatory approvals,
will not be precluded by proprietary rights of third parties or will ultimately
achieve market acceptance. These product candidates will require substantial
additional investment, laboratory development, clinical testing and regulatory
approvals prior to their commercialization. We cannot assure you that we will
not experience difficulties that could delay or prevent the successful
development, introduction and marketing of new products.
Before we obtain regulatory approvals for the commercial sale of any of our
products under development, we must demonstrate through preclinical studies and
clinical trials that the product is safe and efficacious for use in each target
indication. The results from preclinical studies and early clinical trials may
not be predictive of results that will be obtained in large-scale testing. We
cannot assure you that our clinical trials will demonstrate the safety and
efficacy of any products or will result in marketable products. A number of
companies in the biotechnology industry have suffered significant setbacks in
advanced clinical trials, even after promising results in earlier trials.
Clinical trials or marketing of any potential diagnostic or therapeutic products
may expose us to liability claims for the use of these diagnostic or therapeutic
products. We may not be able to maintain product liability insurance or
sufficient coverage may not be available at a reasonable cost. In addition, as
we develop diagnostic or therapeutic products internally, we will have to make
significant investments in diagnostic or therapeutic product development,
marketing, sales and regulatory compliance resources. We will also have to
establish or contract for the manufacture of products, including supplies of
drugs used in clinical trials, under the current Good Manufacturing Practices,
or cGMP, of the FDA. We also cannot assure you that product issues will not
arise following successful clinical trials and FDA approval.
The rate of completion of clinical trials also depends on the rate of patient
enrollment. Patient enrollment depends on many factors, including the size of
the patient population, the nature of the protocol, the proximity of patients to
clinical sites and the eligibility criteria for the study. Delays in planned
patient enrollment may result in increased costs and delays, which could have a
harmful effect on our ability to develop the products in our pipeline. If we are
unable to develop and commercialize products on a timely basis or at all, our
business could be significantly and adversely affected.
Competition In Our Field Is Intense And Likely To Increase.
We face, and will continue to face, intense competition from one or more of the
following entities:
- pharmaceutical companies;
- biotechnology companies;
- bioinformatics companies;
- diagnostic companies;
- academic and research institutions; and
- government agencies.
All of our products and product candidate are subject to significant competition
from organizations that are pursuing technologies and products that are the same
as or similar to our technology and products. Many of the organizations
competing with us have greater capital resources, research and development
staffs and facilities and marketing capabilities.
-8-
Before we recover development expenses for our products and technologies, the
products or technologies may become obsolete as a result of technological
developments by others or us. Our products could also be made obsolete by new
technologies, which are less expensive or more effective. We may not be able to
make the enhancements to our technology necessary to compete successfully with
newly emerging technologies and failure to do so could significantly and
adversely affect our business.
We Rely Heavily On Our Collaborative Partners.
Our success depends in significant part upon the success of our collaborative
partners. We have entered into the following agreements for the sale, marketing,
distribution and manufacture of our products, product candidates and
technologies:
- license from The Dow Chemical Company relating to the Quadramet
technology;
- agreement for manufacture of Quadramet by Bristol Myers Squibb
(formerly The DuPont Pharmaceuticals Company);
- joint venture with Progenics Pharmaceuticals for the development of
PSMA for in vivo immunotherapy for prostate and other cancers;
- licensing agreement with Molecular Staging for technology to be used
in developing in vitro diagnostic tests using PSMA and prostate
specific antigen, or PSA;
- a Supply Agreement with Laureate Pharma L.P. for the production of our
ProstaScint product;
- an agreement with Matritech to market and distribute NMP22 BladderChek
to urologists and oncologists in the United States;
- marketing, license and supply agreements with Advanced Magnetics, Inc.
related to Combidex and Code 7228;
- a License Agreement between our joint venture, PSMA Development
Company LLC, and AlphaVax Human Vaccines, Inc.;
- a Collaboration Agreement between our joint venture and Abgenix, Inc;
and
- sub-license and marketing agreement with Berlex Laboratories, Inc.
relating to the Quadramet technology which we licensed from The Dow
Chemical Company. However, on June 16, 2003, we entered into an
agreement with Berlex to reacquire the marketing rights to Quadramet
in North America and South America. The reacquisition of the marketing
rights to Quadramet is anticipated to close within 90 days from June
16, 2003, subject to us obtaining the necessary financing for an
upfront payment to Berlex for such reacquisition.
Because our collaborative partners are responsible for certain of our sales,
marketing, manufacturing and distribution activities, these activities are
outside our direct control. We cannot assure you that our partners will perform
their obligations under these agreements with us or that our partners will not
enter into arrangements with third parties that may negatively impact the
economic benefit we hope to derive from their agreements with us. For example,
Matritech retained the ability to market its NMP22 BladderChek to primary care
physicians and others and has begun such marketing efforts. In the event that
our collaborative partners do not successfully market and sell our products, are
-9-
entitled to enter into third party arrangements that may economically
disadvantage us, or breach their obligations under our agreements, our products
may not be commercially successful, any success may be delayed and new product
development could be inhibited with the result that our business could be
significantly and adversely affected.
Our Business Could Be Harmed If Our Collaborative Arrangements Expire Or Are
Terminated Early.
We cannot assure you that we will be able to maintain our existing collaborative
arrangements. If they expire or are terminated, we cannot assure you that they
will be renewed or that new arrangements will be available on acceptable terms,
if at all. In January 2003, we provided Draximage Inc. with notice of our intent
to terminate our Product Manufacturing and Supply Agreement and License
Agreement with Draximage relating to the BrachySeed products. In April 2003, we
entered into an agreement with Draximage formally terminating each of these
agreements.
In addition, we cannot assure you that any new arrangements or renewals of
existing arrangements will be successful, that the parties to any new or renewed
agreements will perform adequately or that any former or potential collaborators
will not compete with us.
We cannot assure you that our existing or future collaborations will lead to the
development of product candidates or technologies with commercial potential,
that we will be able to obtain proprietary rights or licenses for proprietary
rights for our product candidates or technologies developed in connection with
these arrangements or that we will be able to ensure the confidentiality of
proprietary rights and information developed in such arrangements or prevent the
public disclosure thereof.
The Termination Of One Or More License Agreements That Are Important In The
Manufacture Of Our Current Products And New Product Research And Development
Activities Would Harm Our Business.
We are a party to license agreements under which we have rights to use
technologies owned by other companies in the manufacture of our products and in
our proprietary research, development and testing processes. We are the
exclusive licensee of certain patents and patent applications held by the
University of North Carolina at Chapel Hill covering part of the technology used
in the proteomics program and of certain patents and patent applications held by
the Memorial Sloan-Kettering Institute covering PSMA. We also depend upon the
enforceability of our license with The Dow Chemical Company with respect to
Quadramet. If the licenses were terminated, we may not be able to find suitable
alternatives to this technology on a timely basis or on reasonable terms, if at
all. The loss of the right to use these technologies that we have licensed would
significantly and adversely affect our business.
We Have Limited Sales, Marketing And Distribution Capabilities For Our Products.
We have established an internal sales force that is responsible for marketing
and selling ProstaScint and NMP22 BladderChek. However, such internal sales
force has limited sales, marketing and distribution capabilities for our
products, compared to those of many of our competitors. We depend on Berlex
Laboratories, Inc. for the sale, marketing and distribution of Quadramet in the
United States. On June 16, 2003, however, we entered into an agreement with
Berlex whereby marketing rights held by Berlex to market Quadramet in North
America and South America are to be returned to us in exchange for an up front
payment and royalties based on future sales. The reacquisition of the marketing
rights to Quadramet is anticipated to close within 90 days from June 16, 2003,
subject to our obtaining the necessary financing for the upfront payment to
Berlex for such reacquisition. In locations outside of the United States, we
have not established a selling presence. If we are unable to establish and
maintain significant sales, marketing and distribution efforts, either
internally or through arrangements with third parties, our business may be
significantly and adversely affected.
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There Are Risks Associated With The Manufacture And Supply Of Our Products.
If we are to be successful, our products will have to be manufactured by
contract manufacturers in compliance with regulatory requirements and at costs
acceptable to us. We cannot assure you that we will be able to arrange for the
manufacture of our products on commercially reasonable terms. If we are unable
to successfully arrange for the manufacture of our products and product
candidates, we will not be able to successfully commercialize our products and
our business will be significantly and adversely affected.
ProstaScint was manufactured at a cGMP compliant manufacturing facility operated
by Laureate Pharma L.P. (formerly Bard BioPharma L.P.). We had access to
Laureate's facility for continued manufacturing of the product until January
2002. We entered into a Development and Manufacturing Agreement with DSM
Biologics Company B.V. in July 2000, which we intended would replace our
arrangement with Laureate with respect to ProstaScint. We entered into a new
Contract Manufacturing Agreement with Laureate Pharma L.P. in January 2003. We
have built our inventory of ProstaScint to meet our product requirements in the
short term. Our failure to maintain a long term supply agreement on commercially
reasonable terms will have a material adverse effect on our business, financial
condition and results of operations.
Quadramet is manufactured by Bristol-Myers Squibb (BMS) (formerly DuPont),
pursuant to an agreement with both Berlex and Cytogen. Some components of
Quadramet, particularly Samarium153 and EDTMP, are provided to BMS by outside
suppliers. Due to radioactive decay, Samarium153 must be produced on a weekly
basis. BMS obtains its requirements for Samarium153 from one supplier.
Alternative sources for these components may not be readily available. If BMS
cannot obtain sufficient quantities of the components on commercially reasonable
terms, or in a timely manner, it would be unable to manufacture Quadramet on a
timely and cost-effective basis, which could have a material adverse effect on
our business, financial condition and results of operations.
Pursuant to the terms of our distribution agreement with Matritech, we rely on
Matritech as the sole supplier of NMP22 BladderChek. Matritech uses independent
contractors to manufacture the product. If Matritech fails to, or is unable to
provide the product, we could experience a material adverse effect on our
business, financial condition and results of operations.
The Company, our contract manufacturers and testing laboratories are required to
adhere to United States Food & Drug Administration regulations setting forth
requirements for cGMP, and similar regulations in other countries, which include
extensive testing, control and documentation requirements. Ongoing compliance
with cGMP, labeling and other applicable regulatory requirements is monitored
through periodic inspections and market surveillance by state and federal
agencies, including the FDA, and by comparable agencies in other countries.
Failure of our contract vendors or us to comply with applicable regulations
could result in sanctions being imposed on us, including fines, injunctions,
civil penalties, failure of the government to grant premarket clearance or
premarket approval of drugs, delays, suspension or withdrawal of approvals,
seizures or recalls of products, operating restrictions and criminal
prosecutions any of which could significantly and adversely affect our business.
Failure Of Consumers To Obtain Adequate Reimbursement From Third-Party Payors
Could Limit Market Acceptance And Affect Pricing Of Our Products.
Our business, financial condition and results of operations will continue to be
affected by the efforts of governments and other third-party payors to contain
or reduce the costs of healthcare. There have been, and we expect that there
will continue to be, a number of federal and state proposals to implement
government control of pricing and profitability of therapeutic and diagnostic
imaging agents such as our products. In addition, an emphasis on managed care
increases possible pressure on pricing of these products. While we cannot
predict whether these legislative or regulatory proposals will be adopted, or
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the effects these proposals or managed care efforts may have on our business,
the announcement of these proposals and the adoption of these proposals or
efforts could affect our stock price or our business. Further, to the extent
these proposals or efforts have an adverse effect on other companies that are
our prospective corporate partners, our ability to establish necessary strategic
alliances may be harmed.
Sales of our products depend in part on reimbursement to the consumer from
third-party payors, including Medicare, Medicaid and private health insurance
plans. Third-party payors are increasingly challenging the prices charged for
medical products and services. We cannot assure you that our products will be
considered cost-effective and that reimbursement to consumers will continue to
be available, or will be sufficient to allow us to sell our products on a
competitive basis. Approval of our products for reimbursement by a third-party
payor may depend on a number of factors, including the payor's determination
that our products are clinically useful and cost-effective, medically necessary
and not experimental or investigational. Reimbursement is determined by each
payor individually and in specific cases. The reimbursement process can be time
consuming. If we cannot secure adequate third-party reimbursement for our
products, our business could be significantly and adversely affected.
If We Are Unable To Comply With Applicable Governmental Regulation We May Not Be
Able To Continue Our Operations.
Any products tested, manufactured or distributed by us or on our behalf pursuant
to FDA approvals are subject to pervasive and continuing regulation by numerous
regulatory authorities, including primarily the FDA. We may be slow to adapt, or
we may never adapt to changes in existing requirements or adoption of new
requirements or policies. Our failure to comply with regulatory requirements
could subject us to enforcement action, including product seizures, recalls,
withdrawal, suspension, or revocation of approvals, restrictions on or
injunctions against marketing our products based on our technology, and civil
and criminal penalties. We cannot assure you that we will not be required to
incur significant costs to comply with laws and regulations in the future or
that laws or regulations will not create an unsustainable burden on our
business.
Numerous federal, state and local governmental authorities, principally the FDA,
and similar regulatory agencies in other countries, regulate the preclinical
testing, clinical trials, manufacture and promotion of any compounds or agents
we or our collaborative partners develop, and the manufacturing and marketing of
any resulting drugs. The product development and regulatory approval process is
lengthy, expensive, uncertain and subject to delays.
The regulatory risks we face also include the following:
- any compound or agent we or our collaborative partners develop must
receive regulatory agency approval before it may be marketed as a drug
in a particular country;
- the regulatory process, which includes preclinical testing and
clinical trials of each compound or agent in order to establish its
safety and efficacy, varies from country to country, can take many
years and requires the expenditure of substantial resources;
- in all circumstances, approval of the use of previously unapproved
radioisotopes in certain of our products requires approval of either
the Nuclear Regulatory Commission or equivalent state regulatory
agencies. A radioisotope is an unstable form of an element which
undergoes radioactive decay, thereby emitting radiation which may be
used, for example, to image or destroy harmful growths or tissue. We
cannot assure you that such approvals will be obtained on a timely
basis, or at all;
- data obtained from preclinical and clinical activities are susceptible
to varying interpretations which could delay, limit or prevent
regulatory agency approval; and
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- delays or rejections may be encountered based upon changes in
regulatory agency policy during the period of product development
and/or the period of review of any application for regulatory agency
approval. These delays could adversely affect the marketing of any
products we or our collaborative partners develop, impose costly
procedures upon our activities, diminish any competitive advantages we
or our collaborative partners may attain and adversely affect our
ability to receive royalties.
We cannot assure you that, even after this time and expenditure, regulatory
agency approvals will be obtained for any compound or agent developed by or in
collaboration with us. Moreover, regulatory agency approval for a product or
agent may entail limitations on the indicated uses that could limit the
potential market for any such product. Furthermore, if and when such approval is
obtained, the marketing, manufacture, labeling, packaging, reporting, storage,
advertising and promotion and record keeping related to our products would
remain subject to extensive regulatory requirements. Discovery of previously
unknown problems with a drug, its manufacture or its manufacturer may result in
restrictions on such drug, manufacture or manufacturer, including withdrawal of
the drug from the market. Failure to comply with regulatory requirements could
result in fines, injunctions, seizures, recalls, suspension or withdrawal of
regulatory approvals, operating restrictions and criminal prosecution.
The United States Food, Drug and Cosmetics Act requires (i) that our products be
manufactured in FDA registered facilities subject to inspection, and (ii) that
we comply with cGMP, which imposes certain procedural and documentation
requirements upon us and our manufacturing partners with respect to
manufacturing and quality assurance activities. If we or our contract partners
do not comply with cGMP we may be subject to sanctions, including fines,
injunctions, civil penalties, recalls or seizures of products, total or partial
suspension of production, product recalls, failure of the government to grant
premarket clearance or premarket approval for drugs, withdrawal of marketing
approvals and criminal prosecution.
We Could Be Negatively Impacted By Future Interpretation Or Implementation Of
Federal And State Fraud And Abuse Laws, Including Anti-Kickback Laws, The
Federal Stark Law And Other Federal And State Anti-referral Laws.
We are subject to various federal and state laws pertaining to health care fraud
and abuse, including anti-kickback laws and physician self-referral laws.
Violations of these laws are punishable by criminal and/or civil sanctions,
including, in some instances, imprisonment and exclusion from participation in
federal and state health care programs, including Medicare, Medicaid and
Veterans Administration health programs. We have not been challenged by a
governmental authority under any of these laws and believe that our operations
are in compliance with such laws. However, because of the far-reaching nature of
these laws, we may be required to alter one or more of our practices to be in
compliance with these laws. Health care fraud and abuse regulations are complex
and even minor, inadvertent irregularities can potentially give rise to claims
that the statute has been violated. Any violations of these laws could result in
a material adverse effect on our business, financial condition and results of
operations. If there is a change in law, regulation or administrative or
judicial interpretations, we may have to change our business practices or our
existing business practices could be challenged as unlawful, which could have a
material adverse effect on our business, financial condition and results of
operations.
We could become subject to false claims litigation under federal statutes, which
can lead to civil money penalties, criminal fines and imprisonment, and/or
exclusion from participation in Medicare, Medicaid and other federal and state
health care programs. These false claims statutes include the False Claims Act,
which allows any person to bring suit alleging false or fraudulent claims under
federal programs or contracts claims or other violations of the statute and to
share in any amounts paid by the entity to the government in fines or
settlement. Such suits, known as qui tam actions, have increased significantly
in recent years and have increased the risk that a health care company will have
to defend a false claim action, pay fines or be excluded from the Medicare
program, Medicaid programs or other federal and state health care programs as a
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result of an investigation arising out of such action. We cannot assure you that
we will not become subject to such litigation or, if we are not successful in
defending against such actions, that such actions will not have a material
adverse effect on our business, financial condition and results of operations.
We Depend On Attracting And Retaining Key Personnel.
We are highly dependent on the principal members of our management and
scientific staff. The loss of their services might significantly delay or
prevent the achievement of development or strategic objectives. Our success
depends on our ability to retain key employees and to attract additional
qualified employees. Competition for personnel is intense, and we cannot assure
you that we will be able to retain existing personnel or attract and retain
additional highly qualified employees in the future.
During 2002, we announced numerous changes to members of our senior management.
H. Joseph Reiser, Ph.D. who held the position of President and Chief Executive
Officer of the Company from April 1998 until December 2002, resigned from his
position for personal reasons. Michael D. Becker, our former Vice President of
Business Development, was unanimously elected by our board of directors to serve
as Dr. Reiser's replacement as President and Chief Executive Officer. Mr. Becker
was also unanimously elected to serve on our Board of Directors. Dr. Reiser has
remained a member of our Board of Directors. In addition, Lawrence R. Hoffman,
our Vice President and Chief Financial Officer since July 2000, left the Company
to pursue other opportunities as of December 31, 2002. Ms. Thu Dang, our
Director of Finance, was subsequently promoted to Vice President of Finance.
Additionally, in the first quarter of 2003: (i) William Goeckeler, our Vice
President of Research and Development, was promoted to Vice President of
Operations; (ii) Deborah Kaminsky, our Vice President of Sales and Marketing,
shifted her work focus, and serves as our Vice President of Business
Development; (iii) Rita Auld, our Director of Human Resources, was promoted to
Vice President of Human Resources and Administration and Corporate Secretary;
(iv) Corey Jacklin assumed the responsibilities of Senior Director of Sales; and
(v) June Gobern was promoted to Senior Director of Marketing.
We do not typically enter into long-term arrangements with our key personnel. If
we are unable to hire and retain personnel in key positions, our business could
be significantly and adversely affected unless qualified replacements can be
found.
Our Business Exposes Us To Potential Liability Claims That May Exceed Our
Financial Resources, Including Our Insurance Coverage, And May Lead To The
Curtailment Or Termination Of Our Operations.
Our business is subject to product liability risks inherent in the testing,
manufacturing and marketing of our products. We cannot assure you that product
liability claims will not be asserted against us, our collaborators or our
licensees. While we currently maintain product liability insurance in amounts we
believe are adequate, we cannot assure you that such coverage will be adequate
to protect us against future product liability claims or that product liability
insurance will be available to us in the future on commercially reasonable
terms, if at all. Furthermore, we cannot assure you that we will be able to
avoid significant product liability claims and adverse publicity. If liability
claims against us exceed our financial resources we may have to curtail or
terminate our operations. In addition, while we currently maintain directors and
officers liability insurance in amounts we believe are adequate, we cannot
assure you that such coverage will be adequate to cover any claims that we may
be required to satisfy in the future.
-14-
Our Business Involves Environmental Risks That May Result In Liability.
We are subject to a variety of local, state, federal and foreign government
regulations relating to storage, discharge, handling, emission, generation,
manufacture and disposal of toxic, infectious or other hazardous substances used
to manufacture our products. If we fail to comply with these regulations, we
could be liable for damages, penalties or other forms of censure and our
business could be significantly and adversely affected.
Our Intellectual Property Is Difficult To Protect.
Our business and competitive positions are dependent upon our ability to protect
our proprietary technology. Because of the substantial length of time and
expense associated with development of new products, we, like the rest of the
biopharmaceutical industry, place considerable importance on obtaining and
maintaining patent and trade secret protection for new technologies, products
and processes. We have filed patent applications for our technology for
diagnostic and therapeutic products and the methods for its production and use.
The patent positions of pharmaceutical, biopharmaceutical and biotechnology
companies, including us, are generally uncertain and involve complex legal and
factual questions. Our patent applications may not protect our technologies and
products because, among other things:
- there is no guarantee that any of our pending patent applications will
result in issued patents;
- we may develop additional proprietary technologies that are not
patentable;
- there is no guarantee that any patents issued to us, our collaborators
or our licensors will provide a basis for a commercially viable
product;
- there is no guarantee that any patents issued to us or our
collaborators will provide us with any competitive advantage;
- there is no guarantee that any patents issued to us or our
collaborators will not be challenged, circumvented or invalidated by
third parties; and
- there is no guarantee that any patents previously issued to others or
issued in the future will not have an adverse effect on our ability to
do business.
In addition, patent law in the technology fields in which we operate is
uncertain and still evolving, and we cannot assure you as to the degree of
protection that will be afforded any patents we are issued or license from
others. Furthermore, we cannot assure you that others will not independently
develop similar or alternative technologies, duplicate any of our technologies,
or, if patents are issued to us, design around the patented technologies
developed by us. In addition, we could incur substantial costs in litigation if
we are required to defend ourselves in patent suits by third parties or if we
initiate such suits. We cannot assure you that, if challenged by others in
litigation, the patents we have been issued, or which have been assigned or have
been licensed from others will not be found invalid. We cannot assure you that
our activities would not infringe patents owned by others. Defense and
prosecution of patent matters can be expensive and time-consuming and,
regardless of whether the outcome is favorable to us, can result in the
diversion of substantial financial, managerial and other resources. An adverse
outcome could:
- subject us to significant liability to third parties;
- require us to cease any related research and development activities
and product sales; or
- require us to obtain licenses from third parties.
-15-
We cannot assure you that any licenses required under any such third-party
patents or proprietary rights would be made available on commercially reasonable
terms, if at all. Moreover, the laws of certain countries may not protect our
proprietary rights to the same extent as the laws of the United States. We
cannot predict whether us or our competitors' pending patent applications will
result in the issuance of valid patents which may significantly and adversely
affect our business.
We Cannot Be Certain That Our Security Measures Protect Our Unpatented
Proprietary Technology.
We also rely upon trade secret protection for some of our confidential and
proprietary information that is not subject matter for which patent protection
is available. To help protect our rights, we require all employees, consultants,
advisors and collaborators to enter into confidentiality agreements that require
disclosure, and in most cases, assignment to us, of their ideas, developments,
discoveries and inventions, and that prohibit the disclosure of confidential
information to anyone outside Cytogen or our subsidiaries. We cannot assure you,
however, that these agreements will provide adequate protection for our trade
secrets, know-how or other proprietary information or prevent any unauthorized
use or disclosure.
We Are Currently Subject To Patent Litigation.
On March 17, 2000, we were served with a complaint filed against us in the
United States District Court for the District of New Jersey by M. David
Goldenberg ("Goldenberg") and Immunomedics, Inc. (collectively "Plaintiffs").
The litigation claims that our Prostascint product infringes a patent
purportedly owned by Goldenberg and licensed to Immunomedics. We believe that
ProstaScint does not infringe this patent, and that the patent is invalid and
unenforceable. The patent sought to be enforced in the litigation has now
expired; as a result, the claim, even if successful, would not result in an
injunction barring the continued sale of ProstaScint or affect any other of our
products or technology. In addition, we have certain rights to indemnification
against litigation and litigation expenses from the inventor of technology used
in ProstaScint, which may be offset against royalty payments on sales of
ProstaScint. However, given the uncertainty associated with litigation, we
cannot give any assurance that the litigation could not result in a material
expenditure to us. On December 17, 2001, Cytogen filed a motion for summary
judgment of non-infringement of the asserted claims of the patent-in-suit. The
Plaintiffs opposed that motion and filed their own cross-motion for summary
judgment of infringement. On July 3, 2002, the Court denied both parties'
summary judgment motions, with leave to renew those motions after presenting
expert testimony and legal argument based upon that testimony. The parties
subsequently presented expert testimony and submitted additional briefing. On
April 29, 2003, our motion for summary judgment of non-infringement of all
asserted claims was granted, plaintiffs' motion for summary judgment of
infringement was denied and the case was ordered closed. On May 12, 2003,
Plaintiffs filed a Notice of Appeal regarding this decision to the U.S. Court of
Appeals for the Federal Circuit.
Our Stock Price Has Been And May Continue To Be Volatile, And Your Investment In
Our Stock Could Decline In Value Or Fluctuate Significantly.
The market prices for securities of biotechnology and pharmaceutical companies
have historically been highly volatile, and the market has from time to time
experienced significant price and volume fluctuations that are unrelated to the
operating performance of particular companies. The market price of our common
stock has fluctuated over a wide range and may continue to fluctuate for various
reasons, including, but not limited to, announcements concerning our competitors
or us regarding:
- results of clinical trials;
- technological innovations or new commercial products;
- changes in governmental regulation or the status of our regulatory
approvals or applications;
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- changes in earnings;
- changes in health care policies and practices;
- developments or disputes concerning proprietary rights;
- litigation or public concern as to safety of the our potential
products; and
- changes in general market conditions.
These fluctuations may be exaggerated if the trading volume of our common stock
is low. These fluctuations may or may not be based upon any of our business or
operating results. Our common stock may experience similar or even more dramatic
price and volume fluctuations which may continue indefinitely.
The following table sets forth the high and low sale prices for our common stock
for each of the quarters in the period beginning April 1, 2000 through March 31,
2003 as reported on the Nasdaq National Market, and as adjusted for our
one-for-ten reverse stock split effected October 25, 2002:
Quarter Ended High Low
------------- ---- ---
June 30, 2000 $106.25 $38.13
September 30, 2000 $113.75 $55.00
December 31, 2000 $71.88 $20.00
March 31, 2001 $65.63 $23.13
June 30, 2001 $61.00 $21.88
September 30, 2001 $53.90 $19.00
December 31, 2001 $45.50 $20.50
March 31, 2002 $34.70 $21.10
June 30, 2002 $22.40 $9.10
September 30, 2002 $11.50 $3.20
December 31, 2002 $8.44 $2.68
March 31, 2003 $3.90 $2.51
We Have Adopted Various Anti-Takeover Provisions Which May Affect The Market
Price Of Our Common Stock.
Our Board of Directors has the authority, without further action by the holders
of common stock, to issue from time to time, up to 5,400,000 shares of preferred
stock in one or more classes or series, and to fix the rights and preferences of
the preferred stock. Pursuant to these provisions, we have implemented a
stockholder rights plan by which one preferred stock purchase right is attached
to each share of common stock, as a means to deter coercive takeover tactics and
to prevent an acquirer from gaining control of us without some mechanism to
secure a fair price for all of our stockholders if an acquisition was completed.
These rights will be exercisable if a person or group acquires beneficial
ownership of 20% or more of our common stock and can be made exercisable by
action of our board of directors if a person or group commences a tender offer
which would result in such person or group beneficially owning 20% or more of
our common stock. Each right will entitle the holder to buy one one-thousandth
of a share of a new series of our junior participating preferred stock for $20.
If any person or group becomes the beneficial owner of 20% or more of our common
stock (with certain limited exceptions), then each right not owned by the 20%
stockholder will entitle its holder to purchase, at the right's then current
exercise price, common shares having a market value of twice the exercise price.
In addition, if after any person has become a 20% stockholder, we are involved
in a merger or other business combination transaction with another person, each
right will entitle its holder (other than the 20% stockholder) to purchase, at
the right's then current exercise price, common shares of the acquiring company
having a value of twice the right's then current exercise price.
-17-
We are subject to provisions of Delaware corporate law which, subject to certain
exceptions, will prohibit us from engaging in any "business combination" with a
person who, together with affiliates and associates, owns 15% or more of our
common stock for a period of three years following the date that the person came
to own 15% or more of our common stock unless the business combination is
approved in a prescribed manner.
These provisions of the stockholder rights plan, our certificate of
incorporation, and of Delaware law may have the effect of delaying, deterring or
preventing a change in control of Cytogen, may discourage bids for our common
stock at a premium over market price and may adversely affect the market price,
and the voting and other rights of the holders, of our common stock.
The Liquidity Of Our Common Stock Could Be Adversely Affected If We Are Delisted
From The Nasdaq National Market.
On August 14, 2002, we announced that we had received notification from the
Nasdaq Stock Market, Inc. that our common stock had closed below the minimum
$1.00 per share requirement for the previous 30 consecutive trading days as
required under Marketplace Rule 4450(a)(5). In accordance with Marketplace Rule
4450 (e)(2), we were provided with 90 calendar days, or until November 12, 2002,
to regain compliance by having the bid price for our common stock close at $1.00
or greater for a minimum period of 10 consecutive trading days.
On September 26, 2002, we announced that our Board of Directors unanimously
approved, and recommended to our stockholders, a proposal that would give the
Board of Directors authority to effect a reverse stock split of our common
stock, at a ratio of up to one-for-ten at any time prior to December 31, 2002. A
special meeting of our stockholders was held on October 25, 2002 to consider
such recommendation. Pursuant to the authority granted to our Board of Directors
at the special meeting, on October 25, 2002, we implemented a one-for-ten
reverse split of our outstanding and authorized shares of common stock.
We subsequently achieved compliance with Nasdaq Marketplace Rule 4450(a)(5), and
received a letter from Nasdaq notifying us of such compliance on November 11,
2002.
We cannot assure you that we will continue to maintain compliance with this
Marketplace Rule, or any other Listing Standards which may apply to us, and as
such, we may once again face delisting from the Nasdaq National Market in the
future. Specifically, we cannot assure you that we will be able to maintain
compliance with the minimum equity and market value of listed securities
requirements for continued listing on the Nasdaq National Market as set forth in
Marketplace Rule 4310(c)(2)(B).
In the event that we are unable maintain compliance with all relevant Nasdaq
listing standards, our securities may be subject to delisting from the Nasdaq
National Market. If such delisting occurs, the market price and market liquidity
of our common stock may be adversely affected.
Alternatively, if faced with such delisting, we may submit an application to
transfer the listing of our common stock to the Nasdaq SmallCap Market. The
Nasdaq SmallCap Market also has a $1.00 minimum bid price requirement.
If our common stock is delisted by Nasdaq, our common stock would be eligible to
trade on the OTC Bulletin Board maintained by Nasdaq, another over-the-counter
quotation system, or on the pink sheets where an investor may find it more
difficult to dispose of or obtain accurate quotations as to the market value of
our common stock. In addition, we would be subject to a rule promulgated by the
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Securities and Exchange Commission that, if we fail to meet criteria set forth
in such rule, imposes various practice requirements on broker-dealers who sell
securities governed by the rule to persons other than established customers and
accredited investors. Consequently, such rule may deter broker-dealers from
recommending or selling our common stock, which may further affect the liquidity
of our common stock.
Delisting from Nasdaq will make trading our common stock more difficult for
investors, potentially leading to further declines in our share price. It would
also make it more difficult for us to raise additional capital. Further, if we
are delisted we would also incur additional costs under state blue sky laws in
connection with any sales of our securities. These requirements could severely
limit the market liquidity of our common stock and the ability of our
shareholders to sell our common stock in the secondary market.
A Large Number Of Our Shares Are Eligible For Future Sale Which May Adversely
Impact The Market Price Of Our Common Stock.
A large number of shares of our common stock are already outstanding, issuable
upon exercise of options and warrants, or the achievement of certain milestones
under previously completed acquisitions and may be eligible for resale, which
may adversely affect the market price of our common stock. As of June 18, 2003
we had 9,818,755 shares of common stock outstanding, which number of shares: (i)
includes an aggregate of 241 shares of common stock to be issued to prior
holders of securities of CytoRad Incorporated and Cellcor, Inc., which we
acquired in 1995, upon each such holders respective exchange of such securities;
(ii) excludes 50,000 shares of common stock previously issued by us and
currently held in escrow pending release, upon certain conditions, to Advanced
Magnetics, who currently maintains voting control of such securities; and (iii)
excludes 28,589 shares previously issued by us and currently held for issuance
by the custodian of our Employee Stock Purchase Plan to the participants
thereunder, in the event they elect to purchase such shares. An additional
392,715 shares of common stock are issuable upon the exercise of outstanding
stock options and an additional 322,153 shares of common stock are issuable upon
the exercise of outstanding warrants, including the warrants issued to the
selling stockholders in this prospectus. Substantially all of such shares
subject to outstanding options and warrants will, when issued upon exercise
thereof, be available for immediate resale in the public market pursuant to
either a currently effective registration statement under the Securities Act of
1933, as amended, or pursuant to Rule 144 or Rule 701 promulgated thereunder. In
addition, there are 167,951 additional shares of common stock reserved for
future issuance under our current stock options plans, 3,630 additional shares
of common stock reserved for issuance under our 401(k) Plan and 22,751
additional shares of common stock reserved for the future issuance under our
employee bonus plan. All such reserved shares have been registered with the
Securities and Exchange Commission pursuant to currently effective registration
statements. In addition, there are 95,153 additional shares of common stock,
subject to certain adjustments, reserved for future issuance in connection with
the issuance of a convertible promissory note, having a seven (7) year maturity,
to ELAN Corporation, plc in August 1998.
In connection with our acquisition of Prostagen, Inc. in June 1999, we issued
205,000 unregistered shares of our common stock to the then stockholders of
Prostagen, which shares may be sold from time to time pursuant to Rule 144 under
the Securities Act. Such stockholders also have certain piggyback registration
rights with respect to these shares of common stock. An additional 127,699
shares have been issued in 2002 and were subsequently registered on a
registration statement on Form S-3. An additional $2.0 million worth of Cytogen
common stock, which we are obligated to register under the Securities Act of
1933, as amended, may be issued if certain milestones are achieved in the PSMA
development programs.
On October 25, 2001, we filed with the Securities and Exchange Commission a
shelf registration statement on Form S-3 covering one million (1,000,000) shares
of our common stock. 297,066 and 416,670 of such registered shares were issued
to the State of Wisconsin Investment Board in private offering transactions in
each of January 2002 and June 2002, respectively.
-19-
Availability of a significant number of additional shares of our common stock
could depress the price of our common stock.
Because We Do Not Intend to Pay Any Cash Dividends On Our Shares of Common
Stock, Our Stockholders Will Not Be Able to Receive a Return on Their Shares
Unless They Sell Them.
We have never paid or declared any cash dividends on our common stock or other
securities and intend to retain any future earnings to finance the development
and expansion of our business. We do not anticipate paying any cash dividends on
our common stock in the foreseeable future. Unless we pay dividends, our
stockholders will not be able to receive a return on their shares unless they
sell them.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus includes or incorporates 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, as amended. All statements, other than
statements of historical facts, included or incorporated in this prospectus
regarding our strategy, future operations, financial position, future revenues,
projected costs, prospects, plans and objectives of management are
forward-looking statements. The words "anticipates," "believes," "estimates,"
"expects," "intends," "may," "plans," "projects," "will," "would" and similar
expressions are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words. We cannot
guarantee that we actually will achieve the plans, intentions or expectations
disclosed in our forward-looking statements and you should not place undue
reliance on our forward-looking statements. Actual results or events could
differ materially from the plans, intentions and expectations disclosed in the
forward-looking statements we make. We have included important factors in the
cautionary statements included or incorporated in this prospectus, particularly
under the heading "Risk Factors", that we believe could cause actual results or
events to differ materially from the forward-looking statements that we make.
Our forward-looking statements do not reflect the potential impact of any future
acquisitions, mergers, dispositions, joint ventures or investments we may make.
We do not assume any obligation to update any forward-looking statements.
You should not unduly rely on forward-looking statements contained or
incorporated by reference in this prospectus. Actual results or outcomes may
differ materially from those predicted in our forward-looking statements due to
the risks and uncertainties inherent in our business, including among other
items, risks and uncertainties in:
- our ability to successfully execute our business and financial plans;
- our ability to compete successfully against direct and indirect
competitors;
- our ability to access the capital markets in the near term and in the
future to support our operations and for continued funding of existing
projects and for the pursuit of new projects and to maintain the
listing of our common stock on the Nasdaq National Market;
- our ability to successfully develop and commercialize in-licensed
products such as NMP22 BladderChek, including programs designed to
facilitate the use of our products, such as the Partners in Excellence
or PIE Program;
- our ability to establish and successfully complete clinical trials
where required for product approval;
- our ability to determine and implement the appropriate strategic
initiative for our AxCell Biosciences subsidiary;
- our ability to obtain foreign regulatory approvals for products and to
establish marketing arrangements in countries where approval is
obtained;
- the timing and results of clinical studies and regulatory approvals;
-20-
- demonstration over time of the efficacy and safety of our products;
- our ability to develop new products;
- the degree of competition from existing or new products;
- our ability to protect our intellectual property, including patents
and know-how;
- the ability of Advanced Magnetics to satisfy the conditions specified
by the FDA regarding approval to market Combidex in the United States;
- the ability to attract and retain personnel needed for business
operations and strategic plans;
- shifts in the regulatory environment affecting sale of our products
such as third-party payor reimbursement issues and dependence on our
partners for development of certain projects;
- the ability of us to obtain proper financing to reacquire the rights
to market Quadramet in North America and South America from Berlex
Laboratories, Inc.;
- the ability to attract and maintain, and the ultimate success of,
strategic partnering arrangements, collaborations, and acquisition
candidates;
- our ability to successfully commercialize products through our joint
venture, PSMA Development Company, LLC, with Progenics
Pharmaceuticals, Inc;
- competitive products and technologies; and
- price pressure.
You should read and interpret any forward-looking statements together
with the following documents:
- our most recent Annual Report on Form 10-K, as amended;
- our most recent quarterly report of Form 10-Q;
- the risk factors contained in this prospectus under the caption "Risk
Factors"; and
- our other filings with the Securities and Exchange Commission.
Any forward-looking statement speaks only as of the date on which that
statement is made. We will not update any forward-looking statement to reflect
events or circumstances that occur after the date on which such statement is
made.
USE OF PROCEEDS
We will not receive any proceeds from the sale of shares by the selling
stockholders.
The selling stockholders will pay any underwriting discounts and
commissions and expenses incurred by the selling stockholders for brokerage,
accounting, tax or legal services or any other expenses incurred by the selling
stockholders in disposing of the shares. We will bear all other costs, fees and
expenses incurred in effecting the registration of the shares covered by this
prospectus, including, without limitation, all registration and filing fees,
Nasdaq listing fees and fees and expenses of our counsel and our accountants.
-21-
SELLING STOCKHOLDERS
On June 6, 2003, we entered into a Securities Purchase Agreement with
certain institutional investors pursuant to which we issued and sold 1,052,632
shares of our common stock at $4.75 per share and issued warrants to purchase
315,790 shares of our common stock at an exercise price of $6.91 per share to
the investors. Pursuant to the above private placement, we entered into a
Registration Rights Agreement with the institutional investors which requires us
to register on a Form S-3, the shares issued to the investors and the shares
issuable upon exercise of the warrants.
The following table sets forth, to our knowledge, certain information
about the selling stockholders as of June 18, 2003.
Beneficial ownership is determined in accordance with the rules of the
SEC, and includes voting or investment power with respect to shares. Shares of
common stock issuable under stock options and warrants that are exercisable
within 60 days after June 18, 2003 are deemed outstanding for computing the
percentage ownership of the person holding the options and warrants but are not
deemed outstanding for computing the percentage ownership of any other person.
Unless otherwise indicated below, to our knowledge, all persons named in the
table have sole voting and investment power with respect to their shares of
common stock, except to the extent authority is shared by spouses under
applicable law. The inclusion of any shares in this table does not constitute an
admission of beneficial ownership for the person named below.
Number of
Shares of Common Stock Shares of Shares of Common Stock
Name of Selling Beneficially Owned Prior to Common Stock to be Beneficially Owned
Stockholder Offering (1) Being Offered(1) After Offering (1)
-------------------------- ----------------------------- ---------------- ---------------------------
Number Percentage (2) Number Percentage (2)
-------------------------- ----------- -------------- ---------------- -------- --------------
Bonanza Master Fund Ltd. 684,211(3) 6.86% 684,211 0 *
BayStar Capital II LP 684,211(3) 6.86% 684,211 0 *
--------------------------
* Less than one percent.
(1) Wedo not know when or in what amounts a selling stockholder may offer
shares for sale. The selling stockholders might not sell any or all of the
shares offered by this prospectus. Because the selling stockholders may
offer all or some of the shares pursuant to this offering, and because
there are currently no agreements, arrangements or understandings with
respect to the sale of any of the shares, we cannot estimate the number of
the shares that will be held by the selling stockholders after completion
of the offering. However, for purposes of this table, we have assumed that,
after completion of the offering, none of the shares covered by this
prospectus will be held by the selling stockholders.
(2) Applicable percentage ownership is based on 9,818,755 shares of common
stock outstanding as of June 18, 2003, plus any common stock equivalent or
convertible securities held or shares beneficially owned by each such
holder.
(3) Includes 526,316 shares of common stock held by the selling stockholder and
157,895 shares of common stock issuable to the selling stockholders upon
exercise of a warrant held by the selling stockholder. The exercise price
to purchase each share of common stock pursuant to the warrant is $6.91 per
share. Although the shares of common stock issuable upon exercise of the
warrants are included herein, the terms of the warrants prohibit the
exercise thereof in the event such exercise would cause the holder's
beneficial ownership percentage to exceed 4.99%.
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PLAN OF DISTRIBUTION
The selling stockholders and any of their pledgees, assignees and
successors-in-interest may, from time to time, sell any or all of their shares
of common stock on any stock exchange, market or trading facility on which the
shares are traded or in private transactions. These sales may be at fixed or
negotiated prices. The selling stockholders may use any one or more of the
following methods when selling shares:
- ordinary brokerage transactions and transactions in which the
broker-dealer solicits purchasers;
- block trades in which the broker-dealer will attempt to sell the
shares as agent but may position and resell a portion of the block as
principal to facilitate the transaction;
- purchases by a broker-dealer as principal and resale by the
broker-dealer for its account;
- an exchange distribution in accordance with the rules of the
applicable exchange;
- privately negotiated transactions;
- settlement of short sales;
- broker-dealers may agree with the selling stockholders to sell a
specified number of such shares at a stipulated price per share;
- a combination of any such methods of sale; and
- any other method permitted pursuant to applicable law.
The selling stockholders may also sell shares under Rule 144 under the
Securities Act, if available, rather than under this prospectus.
Broker-dealers engaged by the selling stockholders may arrange for
other brokers-dealers to participate in sales. Broker-dealers may receive
commissions or discounts from the selling stockholders (or, if any broker-dealer
acts as agent for the purchaser of shares, from the purchaser) in amounts to be
negotiated. The selling stockholders do not expect these commissions and
discounts to exceed what is customary in the types of transactions involved.
The selling stockholders may from time to time pledge or grant a
security interest in some or all of the shares of common stock owned by them
and, if they default in the performance of their secured obligations, the
pledgees or secured parties may offer and sell the shares of common stock from
time to time under this prospectus, or under an amendment to this prospectus
under Rule 424(b)(3) or other applicable provision of the Securities Act of
1933, as amended, amending the list of selling stockholders to include the
pledgee, transferee or other successors in interest as selling stockholders
under this prospectus.
The selling stockholders and any broker-dealers or agents that are
involved in selling the shares may be deemed to be "underwriters" within the
meaning of the Securities Act in connection with such sales. In such event, any
commissions received by such broker-dealers or agents and any profit on the
resale of the shares purchased by them may be deemed to be underwriting
commissions or discounts under the Securities Act. The selling stockholders have
informed us that it does not have any agreement or understanding, directly or
indirectly, with any person to distribute the common stock.
-23-
We are required to pay all fees and expenses incident to the
registration of the shares. We have agreed to indemnify the selling stockholders
against certain losses, claims, damages and liabilities, including liabilities
under the Securities Act.
LEGAL MATTERS
The validity of the shares of common stock offered hereby has been
passed upon by Hale and Dorr LLP, Princeton, New Jersey.
WHERE YOU CAN FIND MORE INFORMATION
We file reports, proxy statements and other documents with the SEC. You
may read and copy any document we file at the SEC's public reference room at
Judiciary Plaza Building, 450 Fifth Street, N.W., Room 1024, Washington, D.C.
20549. You should call 1-800-SEC-0330 for more information on the public
reference room. Our SEC filings are also available to you on the SEC's Internet
site at http://www.sec.gov.
This prospectus is part of a registration statement that we filed with
the SEC. The registration statement contains more information than this
prospectus regarding us and our common stock, including certain exhibits and
schedules. You can obtain a copy of the registration statement from the SEC at
the address listed above or from the SEC's Internet site.
INFORMATION INCORPORATED BY REFERENCE
The SEC requires us to "incorporate" into this prospectus information
that we file with the SEC in other documents. This means that we can disclose
important information to you by referring to other documents that contain that
information. The information incorporated by reference is considered to be part
of this prospectus. Information contained in this prospectus and information
that we file with the SEC in the future and incorporate by reference in this
prospectus automatically updates and supersedes previously filed information. We
incorporate by reference the documents listed below and any future filings we
make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities
Exchange Act of 1934, prior to the sale of all the shares covered by this
prospectus.
(1) Our Annual Report on Form 10-K for the year ended December 31, 2002,
as filed with the Securities and Exchange Commission on March 31,
2003;
(2) Amendment Number 1 to our Annual Report on Form 10-K/A for the year
ended December 31, 2002, as filed with the Securities and Exchange
Commission on March 31, 2003;
(3) Our Current Report on Form 8-K, dated April 8, 2003, as filed with the
Securities and Exchange Commission on April 9, 2003;
(4) Our Current Report on Form 8-K, dated May 14, 2003, as filed with the
Securities and Exchange Commission on May 14, 2003;
(5) Our Quarterly Report on Form 10-Q for the period ended March 31, 2003,
as filed with the Securities and Exchange Commission on May 14, 2003;
-24-
(6) Our Current Report on Form 8-K, dated June 6, 2003, as filed with the
Securities and Exchange Commission on June 9, 2003;
(7) The description of our common stock contained in our Registration
Statement on Form 8-A, as supplemented by the disclosure set forth in
Exhibit 3.1 to our Form 10-Q Quarterly Report for the quarter ended
June 30, 2000 and Exhibit 3 to our Form 10-Q Quarterly Report for the
quarter ended June 30, 1996;
(8) The description of our Series C Junior Participating Preferred Stock
contained in Exhibit 1 to our Current Report on Form 8-K filed with
the Securities and Exchange Commission on June 24, 1998; and
(9) All of our filings pursuant to the Exchange Act after the date of
filing the initial registration statement and prior to effectiveness
of the registration statement.
You may request a copy of these documents, which will be provided to
you at no cost, by writing or telephoning us using the following contact
information:
Cytogen Corporation
650 College Road East, 3rd Floor
Princeton, New Jersey 08540
Attention: Corporate Communications
Telephone: 609-750-8200
You should rely 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 these securities in any jurisdiction where the offer is not permitted.
You should not assume that the information in this prospectus or any prospectus
supplement is accurate as of any date other than the date on the front of these
documents.
-25-
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The following table sets forth the various expenses to be incurred in
connection with the sale and distribution of the securities being registered
hereby, all of which will be borne by Cytogen Corporation (except any
underwriting discounts and commissions and expenses incurred by the selling
stockholders for brokerage, accounting, tax or legal services or any other
expenses incurred by the selling stockholders in disposing of the shares). All
amounts shown are estimates except the Securities and Exchange Commission
registration fee.
Filing Fee - Securities and Exchange Commission ........ $ 822.54
Legal fees and expenses................................. $15,000.00
Accounting fees and expenses............................ $12,000.00
==========
Total Expenses................................. $27,822.54
Item 15. Indemnification of Directors and Officers.
Subsection (a) of Section 145 of the Delaware General Corporation Law
empowers a corporation to indemnify any person who was or is threatened to be
made a party to any threatened, pending or completed action, suit or proceeding,
whether civil, criminal, administrative or investigative (other than an action
by or in the right of the corporation) by reason of the fact that he or she is
or was a director, officer, employee or agent of the corporation, or is or was
serving at the request of the corporation as a director, officer, employee or
agent of another corporation, partnership, joint venture, trust or other
enterprise, against expenses (including attorneys' fees), judgments, fines and
amounts paid in settlement actually and reasonably incurred by him or her in
connection with such action, suit or proceeding if he or she acted in good faith
and in a manner he or she reasonably believed to be in or not opposed to the
best interests of the corporation, and, with respect to any criminal action or
proceeding, had no reasonable cause to believe his or her conduct was unlawful.
Subsection (b) of Section 145 empowers a corporation to indemnify any
person who was or is a party or is threatened to be made a party to any
threatened, pending or completed action or suit by or in the right of the
corporation to procure a judgment in its favor by reason of the fact that he or
she is or was a director, officer, employee or agent of the corporation, or is
or was serving at the request of the corporation as a director, officer,
employee or agent of another corporation, partnership, joint venture, trust or
other enterprise, against expenses (including attorneys' fees) actually and
reasonably incurred by him or her in connection with the defense or settlement
of such action or suit if he or she acted in good faith and in a manner he or
she reasonably believed to be in or not opposed to the best interests of the
corporation and except that no indemnification shall be made in respect of any
claim, issue or matter as to which such person shall have been adjudged to be
liable to the corporation unless and only to the extent that the Court of
Chancery or the court in which such action or suit was brought shall determine
upon application that, despite the adjudication of liability but in view of all
of the circumstances of the case, such person is fairly and reasonably entitled
to indemnity for such expenses which the Court of Chancery or such other court
shall deem proper.
II-1
Section 145 further provides that to the extent a director or officer
of a corporation has been successful in the defense of any action, suit or
proceeding referred to in subsection (a) and (b) or in the defense of any claim,
issue or matter therein, he or she shall be indemnified against expenses
(including attorneys' fees) actually and reasonably incurred by him or her in
connection therewith; that the indemnification provided by Section 145 shall not
be deemed exclusive of any other rights to which the indemnified party may be
entitled; and that the scope of indemnification extends to directors, officers,
employees, or agents of a constituent corporation absorbed in a consolidation or
merger and persons serving in that capacity at the request of the constituent
corporation for another. Section 145 also empowers a corporation to purchase and
maintain insurance on behalf of a director or officer of the corporation against
any liability asserted against him or her or incurred by him or her in any such
capacity or arising out of his or her status as such whether or not the
corporation would have the power to indemnify him or her against such
liabilities under Section 145.
Section 102(b)(7) of the Delaware General Corporation Law enables a
corporation in its certificate of incorporation to limit the personal liability
of members of its board of directors for violation of a director's fiduciary
duty of care. This section does not, however, limit the liability of a director
for breaching his or her duty of loyalty, failing to act in good faith, engaging
in intentional misconduct or knowingly violating a law, authorizing a payment of
a dividend or approving a stock repurchase in violation of Delaware Corporate
Law or from any transaction in which the director derived an improper personal
benefit. This section also will have no effect on claims arising under the
federal securities laws.
The Company's Certificate of Incorporation and By-Laws provide that the
Company shall indemnify officers and directors and, to the extent permitted by
the Board of Directors, employees and agents of the Company, to the full extent
permitted by and in the manner permissible under the laws of the State of
Delaware. In addition, the By-Laws permit the Board of Directors to authorize
the Company to purchase and maintain insurance against any director, officer,
employee or agent of the Company arising out of his capacity as such.
Cytogen has obtained liability insurance for the benefit of its
directors and officers which provides coverage for losses of directors and
officers for liabilities arising out of claims against such persons acting as
directors or officers of Cytogen (or any subsidiary thereof) due to any breach
of duty, neglect, error, misstatement, misleading statement, omission or act
done by such directors and officers, except as prohibited by law.
Item 16. Exhibits.
(a) Exhibits
5.1** Opinion of Hale and Dorr LLP.
23.1** Consent of Hale and Dorr LLP (To be included in
Exhibit 5.1).
24.1* Power of Attorney. (Included on signature page).
----------
* Filed herewith.
** To be filed by amendment.
II-2
Item 17. Undertakings.
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a
post-effective amendment to this Registration Statement:
(i) To include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933, as amended (the "Securities Act");
(ii) To reflect in the prospectus any facts or events arising after the
effective date of this Registration Statement (or the most recent
post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set forth
in this Registration Statement. Notwithstanding the foregoing, any
increase or decrease in volume of securities offered (if the total
dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form of
prospectus filed with the Commission pursuant to Rule 424(b) if, in
the aggregate, the changes in volume and price represent no more than
20% change in the maximum aggregate offering price set forth in the
"Calculation of Registration Fee" table in the effective Registration
Statement; and
(iii)To include any material information with respect to the plan of
distribution not previously disclosed in this Registration Statement
or any material change to such information in this Registration
Statement;
provided, however, that paragraphs (1)(i) and (1)(ii) do not apply if the
information required to be included in a post-effective amendment by those
paragraphs is contained in periodic reports filed with or furnished to the
Commission by the Registrant pursuant to Section 13 or Section 15(d) of the
Securities Exchange Act of 1934, as amended (the "Exchange Act"), that are
incorporated by reference in this Registration Statement.
(2) That, for the purposes of determining any liability under the
Securities Act, each post-effective amendment shall be deemed to be a new
registration statement relating to the securities offered therein, and the
offering of such securities at the 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.
The Registrant hereby undertakes that, for purposes of determining any
liability under the Securities Act, each filing of the Registrant's annual
report pursuant to Section 13(a) or 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 this
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.
Insofar as indemnification for liabilities arising under the Securities
Act may be permitted to directors, officers and controlling persons of the
Company pursuant to the indemnification provisions described herein, or
otherwise, the Company has been advised that in the opinion of the Securities
and Exchange Commission such indemnification is against public policy as
expressed in the Securities Act and is, therefore, unenforceable. In the event
II-3
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 Securities
Act and will be governed by the final adjudication of such issue.
II-4
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended,
the Registrant certifies that it has reasonable grounds to believe that it meets
all of the requirements for filing on Form S-3 and has duly caused this
Registration Statement to be signed on its behalf by the undersigned, thereunto
duly authorized, in the City of Princeton, State of New Jersey, on July 3, 2003.
CYTOGEN CORPORATION
By: /s/ Michael D. Becker
-------------------------------------
Michael D. Becker
President and Chief Executive Officer
SIGNATURES AND POWER OF ATTORNEY
We, the undersigned officers and directors of Cytogen Corporation,
hereby severally constitute and appoint Michael D. Becker and Thu A. Dang and
each of them singly, our true and lawful attorneys with full power to any of
them, and to each of them singly, to sign for us and in our names in the
capacities indicated below the Registration Statement on Form S-3 filed herewith
and any and all pre-effective and post-effective amendments to said Registration
Statement and generally to do all such things in our name and behalf in our
capacities as officers and directors to enable Cytogen Corporation to comply
with the provisions of the Securities Act of 1933, as amended, and all
requirements of the Securities and Exchange Commission, hereby ratifying and
confirming our signatures as they may be signed by our said attorneys, or any of
them, to said Registration Statement and any and all amendments thereto.
Pursuant to the requirements of the Securities Act of 1933, as amended,
this Registration Statement has been signed by the following persons in the
capacities and on the dates indicated.
Signature Title Date
------------------------------- -------------------------------------- --------------
/s/ Michael D. Becker President, Chief Executive Officer and July 3, 2003
------------------------------- Director (Principal Executive Officer)
Michael D. Becker
/s/ Thu A. Dang Vice President, Finance (Principal July 3, 2003
------------------------------- Financial and Accounting Officer)
Thu A. Dang
/s/ John E. Bagalay, Jr Director July 3, 2003
-------------------------------
John E. Bagalay, Jr.
/s/ Allen Bloom Director July 3, 2003
-------------------------------
Allen Bloom
/s/ Stephen K. Carter Director July 3, 2003
-------------------------------
Stephen K. Carter
/s/ James A. Grigsby Director July 3, 2003
-------------------------------
James A. Grigsby
/s/ Robert F. Hendrickson Director July 3, 2003
-------------------------------
Robert F. Hendrickson
/s/ Kevin G. Lokay Director July 3, 2003
-------------------------------
Kevin G. Lokay
/s/ H. Joseph Reiser Director July 3, 2003
-------------------------------
H. Joseph Reiser
EXHIBIT INDEX
EXHIBIT NUMBER DESCRIPTION
-------------- -----------------------------------------------------------
**5.1 Opinion of Hale and Dorr LLP.
**23.1 Consent of Hale and Dorr LLP (To be included in Exhibit 5.1)
*24.1 Power of Attorney (included on signature page).
* Filed herewith.
** To be filed by amendment.