PROSPECTUS
ENZON, INC.
150,000 Shares
Common Stock
($.01 par value)
----------
This prospectus (the "Prospectus") relates to the offer and sale of up to
150,000 shares of common stock, $.01 par value (the "Common Stock"), of Enzon
Inc. (the "Company" or "Enzon") by certain selling stockholders. Such 150,000
shares of Common Stock are issuable upon exercise of outstanding warrants (the
"Warrants") held by such selling stockholders.
In August 1995, the Company issued Warrants for the purchase of (i) up to
112,500 shares of Common Stock to Edward S. Gordon Company ("ESG") and (ii) up
to 37,500 shares of Common Stock to The Pyne Companies ("Pyne", and together
with ESG collectively referred to herein as the "Selling Stockholders"), in
connection with certain real estate consulting services provided by each of ESG
and Pyne to the Company. Pursuant to the terms of the Warrants, the Company is
required to file a registration statement for the registration of the sale of
the shares of Common Stock issuable upon exercise of the Warrants by ESG and
Pyne. The shares of Common Stock to be received upon exercise of the Warrants
(the "Common Shares") are being offered by the Selling Stockholders hereby. The
Warrants are exercisable at a per share exercise price of $2.50 (as may be
adjusted in accordance with the terms of the Warrants) and expire on August 8,
2000.
The Selling Stockholders may sell the Common Shares from time to time in
transactions in the open market, in negotiated transactions, or by a combination
of these methods, at fixed prices that may be changed, at market prices at the
time of sale, at prices related to market prices or at negotiated prices. The
Selling Stockholders may effect these transactions by selling the Common Shares
to or through broker-dealers, who may receive compensation in the form of
discounts or commissions from the Selling Stockholders or from the purchasers of
the Common Shares for whom the broker-dealers may act as agent or to whom they
may sell as principal, or both in amounts to be negotiated immediately prior to
the sale. Such brokers or dealers and any other participating brokers or dealers
may be deemed to be "underwriters" within the meaning of the Securities Act of
1933, as amended (the "Securities Act") in connection with such sales. See "Plan
of Distribution."
In addition, any securities covered by this Prospectus which qualify for
sale pursuant to Rule 144 may be sold under Rule 144 rather than pursuant to
this Prospectus. To the extent required, the specific shares of Common Stock to
be sold, the name of any successor Selling Stockholders, the public offering
price, the names of any such agent, dealer or underwriter, and any applicable
commission or discount with respect to any particular offer will be set forth in
an accompanying Prospectus Supplement. See "Selling Stockholders" and "Plan of
Distribution."
The Company will bear all expenses in connection with the registration of
the Common Shares herein, which expenses are estimated to be approximately
$29,000. The Selling Stockholders will pay any brokerage compensation in
connection with its sale of the Common Shares. The Company will not receive any
of the proceeds from the sale of the Common Shares by the Selling Stockholder,
but may receive proceeds of up to $375,000 upon exercise of the Warrants. See
"Use of Proceeds."
The Company's Common Stock is traded in the over-the-counter market and is
quoted on the Nasdaq National Market, under the symbol "ENZN." On February 10,
1998 the reported last sale price of the Common Stock, as reported on the Nasdaq
National Market was $5.69 per share.
AN INVESTMENT IN THE SECURITIES OFFERED HEREBY INVOLVES A HIGH
DEGREE OF RISK. SEE "RISK FACTORS" COMMENCING ON PAGE 8.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES
COMMISSION, NOR HAS THE SECURITIES AND EXCHANGE COMMISSION OR ANY
STATE SECURITIES COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY
OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL
OFFENSE.
The date of this Prospectus is February 13, 1998
TABLE OF CONTENTS
Page
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Available Information..................................................... 2
Incorporation of Certain Documents by Reference........................... 2
Prospectus Summary........................................................ 4
Risk Factors.............................................................. 8
Use of Proceeds........................................................... 12
Selling Stockholders...................................................... 12
Plan of Distribution...................................................... 13
Legal Matters............................................................. 14
Experts................................................................... 14
No one has been authorized to give any information or to make any representation
not contained or incorporated by reference in this Prospectus in connection with
this offering. Any information or representation not contained or incorporated
by reference herein must not be relied on as having been authorized by the
Company, the Selling Stockholders or their respective agents. This Prospectus
does not constitute an offer to sell or the solicitation of an offer to buy the
securities offered hereby in any state to any person to whom it is unlawful to
make such offer or solicitation. Except where otherwise indicated, this
Prospectus speaks as of its date and neither the delivery of this Prospectus nor
any sale made hereunder shall, under any circumstances, create an implication
that there has been no change in the affairs of the Company since the date
hereof.
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), and in accordance
therewith files reports, proxy statements and other information with the
Securities and Exchange Commission (the "Commission"). Such reports, proxy
statements and other information filed by the Company can be inspected and
copied at the public reference facilities maintained by the Commission at 450
Fifth Street, N.W., Washington, D.C. 20549, and at the following Regional
Offices of the Commission: New York Regional Office, Seven World Trade Center,
Suite 1300, New York, New York 10048; and Chicago Regional Office, Northwestern
Atrium Center, 500 West Madison Street, Suite 1400, Chicago, Illinois
60661-2511. Copies of such material can be obtained from the Public Reference
Section of the Commission at 450 Fifth Street, N.W., Washington, D.C. 20549 at
prescribed rates. The Commission also maintains a Web site that contains
reports, proxy and information regarding the Company at (http://www.sec.gov).
The Company's Common Stock is listed on the Nasdaq National Market and
reports and other information concerning the Company can be inspected at the
National Association of Securities Dealers, 1735 K Street, N.W., 4th Floor,
Washington, D.C. 20006-1506.
The Company has filed with the Commission a Registration Statement on Form
S-3 (referred to herein together with all amendments and exhibits as the
"Registration Statement") under the Securities Act, with respect to the shares
of Common Stock offered hereby. This Prospectus does not contain all of the
information set forth in the Registration Statement and the exhibits and
schedules thereto, certain parts of which are omitted in accordance with the
rules and regulations of the Commission. For further information with respect to
the Company and the shares of Common Stock offered hereby, reference is hereby
made to the Registration Statement, exhibits and schedules.
The following trademarks and service marks appear in or are incorporated by
reference into,this Prospectus: ADAGEN(R) and ONCASPAR(R) are registered
trademarks of the Company; PEGNOLOGY(R) is a registered service mark of the
Company; SCA(R) is a registered trademark of Enzon Labs Inc., a wholly-owned
subsidiary of the Company; Intron A(R) is a registered trademark of Schering
Corporation.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The Company hereby incorporates by reference into this Prospectus (i) its
Annual Report on Form 10-K for the Fiscal Year Ended June 30, 1997, which
contains audited financial statements for the Company's latest fiscal year for
which a Form 10-K was required to have been filed and incorporates by reference
certain portions of the Company's definitive Proxy Statement for the Annual
Meeting of Stockholders held December 2, 1997 (ii) all other reports filed by
the Company pursuant to Section 13(a) or 15(d) of the Exchange Act since June
30, 1997, including but not limited to, the Quarterly Report on Form 10-Q for
the Quarter Ended September 30, 1997, and (iii) the description of the Company's
Common Stock, $.01 par value, as contained in its registration statement on Form
8-A, filed with the Commission on October 29, 1984, as amended by a Form 8 filed
with the Commission on October 15, 1990.
All documents filed by the Company pursuant to Sections 13(a), 13(c), 14
and 15(d) of the Exchange Act, subsequent to the date hereof and prior to the
filing of a post-effective amendment to the Registration Statement which
indicates that all shares of Common Stock offered hereby have been sold or which
deregisters all shares of Common Stock then remaining unsold, shall be deemed to
be incorporated by reference into this Prospectus and to be a part hereof from
the date of filing of such documents.
2
Any statement contained herein or in a document incorporated or deemed to
be incorporated by reference herein shall be deemed to be modified or superseded
for purposes of this Prospectus to the extent that such statement is modified or
superseded by a statement contained herein or in a subsequently filed document
which also is or is deemed to be incorporated by reference herein. Any such
statement so modified or superseded shall not be deemed, except as so modified
or superseded, to constitute a part of this Prospectus.
The Company will provide, without charge, to each person (including any
beneficial owner) to whom this Prospectus is delivered, upon written or oral
request of such person, a copy of any and all of the information that has been
incorporated by reference in this Prospectus (not including exhibits to such
information unless such exhibits are specifically incorporated by reference into
such information). Such requests should be directed to John Caruso, Vice
President, Business Development, General Counsel and Secretary, at the Company's
principal executive offices at 20 Kingsbridge Road, Piscataway, New Jersey
08854, telephone (732) 980-4500.
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PROSPECTUS SUMMARY
The following summary is qualified in its entirety by reference to the more
detailed information and consolidated financial statements appearing elsewhere,
or incorporated by reference in this Prospectus including the information under
"Risk Factors."
The Company
Enzon, Inc. ("Enzon" or the "Company") is a biopharmaceutical company that
develops, manufactures and markets enhanced therapeutics for life-threatening
diseases through the application of its proprietary technologies, PEG
Modification or the PEG Process and Single-Chain Antigen-Binding (SCA(R))
proteins.
The Company is pursuing a dual strategy for commercializing its proprietary
technologies. In addition to developing and manufacturing products, using the
Company's proprietary technology, and marketing such products, the Company has
established strategic alliances in which Enzon licenses its proprietary
technologies and products in exchange for milestone payments, manufacturing
revenues and/or royalties.
The Company has received marketing approval from the United States Food and
Drug Administration ("FDA") for two of its products: (i) ONCASPAR(R), for the
indication of acute lymphoblastic leukemia ("ALL") in patients who are
hypersensitive to native forms of L-asparaginase and (ii) ADAGEN(R), the first
successful application of enzyme replacement therapy for an inherited disease to
treat a rare form of Severe Combined Immunodeficiency Disease ("SCID"), commonly
known as the "Bubble Boy Disease". ONCASPAR is the enzyme L-asparaginase
modified by the Company's PEG Process and ADAGEN is the enzyme adenosine
deaminase ("ADA") modified by the Company's PEG Process.
The Company manufactures both ADAGEN and ONCASPAR in its South Plainfield,
New Jersey facility and markets ADAGEN on a worldwide basis. ONCASPAR is
marketed in the U.S. by Rhone-Poulenc Rorer Pharmaceuticals, Inc. ("RPR") and in
Europe by Medac GmbH ("Medac"). The Company has also granted exclusive licenses
to RPR to sell ONCASPAR in Canada and Mexico. In December 1997, RPR received
marketing approval for ONCASPAR in Canada. ONCASPAR was approved in Canada for
patients who have been diagnosed with ALL during their childhood. This Canadian
approval broadens the indication for use of ONCASPAR as a front line therapy
over the current approved indication in the United States and Germany. The
Company expects RPR to commence marketing of ONCASPAR in Canada during the first
half of 1998. The Company is entitled to royalties on the sales of ONCASPAR by
RPR, as well as manufacturing revenue from the production of ONCASPAR. The
Company's agreement with Medac requires Medac to purchase ONCASPAR from the
Company at a set price which increases over the term of the agreement. RPR and
Medac are currently conducting clinical trials to expand the use and approved
indications for ONCASPAR.
The PEG Process involves chemically attaching polyethylene glycol ("PEG"),
a relatively non-reactive and non-toxic polymer, to proteins, chemicals and
certain other pharmaceuticals for the purpose of enhancing their therapeutic
value. The attachment of PEG helps to disguise the modified compound and reduce
the recognition of the compound by the immune system, generally lowering
potential immunogenicity. Both the increased molecular size and lower
immunogenicity result in extended circulating blood life, in some cases from
minutes to days. The PEG Process also significantly increases the solubility of
the modified compound which enhances the delivery of the native compound. The
PEG Process was originally covered by a broad patent which expired in late 1996.
The Company has made significant improvements to the original PEG Process,
collectively referred to as Second Generation PEG Technology, and has applied
for and received numerous patents for such improvements. One of the components
of the Second Generation PEG Technology is new linker chemistries; the
4
chemical binding of the PEG to the unmodified protein. These new linkers provide
an enhanced binding of the PEG to the protein resulting in a more stable
compound with increased circulation life. The second generation technology also
allows PEG to bind to different parts of the protein, which may result in
greater activity of the modified protein. Attachment of PEG to the incorrect
site on the protein can result in a loss of its activity or therapeutic effect.
Two products are currently in clinical trials using the Second Generation
PEG Technology; a PEG modified version of Schering-Plough Corporation's
("Schering-Plough") product, INTRON A(R) (interferon alfa 2b), a genetically
engineered anticancer-antiviral drug, and the Company's product, PEG-hemoglobin,
a hemoglobin-based oxygen-carrier being developed for the radio sensitization of
solid hypoxic tumors.
PEG-Intron A, a modified form of Schering-Plough's INTRON A, was developed
by Enzon to have longer lasting activity and an enhanced safety profile.
PEG-Intron A is currently in a large scale Phase III clinical trial in the
United States and Europe for the indications of chronic myelogenous leukemia,
solid tumors and hepatitus C. It is expected that PEG-Intron A will be
administered once a week, compared to the current regimen for unmodified INTRON
A of three times a week. During August 1997, Enzon received $2,500,000 in
milestone payments from Schering-Plough as a result of the product moving into
Phase III clinical trials. Enzon is entitled to an additional $3,000,000 in
payments from Schering-Plough, subject to the achievement of additional
milestones in the product's development. The Company is also entitled to
royalties on worldwide sales of PEG-Intron A and has the option to be the
exclusive manufacturer of PEG-Intron A for the U.S. market. Schering-Plough's
sales of INTRON A were approximately $524 million in 1996. The worldwide market
for alpha interferon products is estimated to be in excess of $1 billion. The
patents covering Schering's INTRON A will begin to expire in 2001. The Company's
Second Generation PEG Technology patents which cover the modified product should
offer extended patent life.
Preclinical studies conducted at Enzon, the University of Wisconsin School
of Veterinary Medicine and Dana Farber Cancer Institute, indicate that the
Company's hemoglobin-based oxygen-carrier, PEG-hemoglobin, may be useful in
treating solid tumors. These studies suggest that PEG-hemoglobin delivers oxygen
to solid hypoxic tumors, thereby enhancing the ability of radiation therapy to
significantly decrease the size of these tumors. It is estimated that
approximately 800,000 cases of solid hypoxic tumors are diagnosed each year in
the United States.
The Company is currently conducting a multi-dose, multi-center clinical
trial of PEG-hemoglobin in cancer patients receiving radiation treatment.
Patients entering this trial receive once-a-week infusions of PEG-hemoglobin
followed by five days of radiation treatment. The protocol for this study calls
for this regimen to be repeated for three weeks. The primary purpose of this
trial is to evaluate safety related to multiple doses of PEG-hemoglobin and
radiation therapy.
The Company also has developed a Third Generation PEG Technology that gives
PEG-modified compounds "Pro Drug" attributes. This is accomplished by attaching
PEG to a compound by means of a covalent bond that is designed to break down
over time, thereby releasing the therapeutic moiety (therapeutic portion of the
compound) in the proximity of the target tissue. These attributes could
significantly enhance the therapeutic value of the new chemicals, as well as
drugs already marketed. The Company believes that the "Pro Drug/Transport
Technology" has broad usefulness and that it can be applied to a wide range of
drugs, such as cancer chemotherapy agents, antibiotics, anti-fungals and
immunosuppressants, as well as to proteins and peptides, including enzymes and
growth factors. The markets for these drugs and biologicals have potentially
large patient populations. The Company is currently applying its Pro
Drug/Transport Technology to certain anticancer agents. Preliminary animal
studies have shown that a compound modified with the Company's Third Generation
PEG Technology accumulates in tumors. A PEG-modified version of camptothecin, a
topo-1 inhibitor, is currently in preclinical studies and the Company is
preparing to file an Investigational New Drug Application (IND) for this product
during the first half of calendar 1998.
5
The Company also has an extensive licensing program for its second
proprietary technology, SCA protein technology. SCA proteins are genetically
engineered proteins designed to overcome the problems hampering the diagnostic
and therapeutic use of conventional monoclonal antibodies. Preclinical studies
have shown that SCA proteins target and penetrate tumors more readily than
conventional monoclonal antibodies. In addition to these advantages, because SCA
proteins are developed at the gene level, they are better suited for targeted
delivery of gene therapy vectors and fully-human SCA proteins can be isolated
directly, with no need for costly "humanization" procedures. Also, many gene
therapy methods require that proteins be produced in an active form inside
cells. SCA proteins can be produced through intracellular expression (inside
cells) more readily than monoclonal antibodies.
Currently, there are nine SCA proteins in Phase I or II clinical trials by
various corporations and institutions. Some of the areas being explored are
cancer therapy, cardiovascular indications and AIDS.
The Company has granted non-exclusive SCA licenses to more than a dozen
companies, including Bristol-Myers Squibb Company ("Bristol Myers"), Baxter
Healthcare Corporation ("Baxter"), Eli Lilly & Co. ("Eli Lilly"), Alexion
Pharmaceuticals Inc. ("Alexion Pharmaceuticals"), and the Gencell division of
RPR ("RPR/Gencell"). These licenses generally provide for upfront payments,
milestone payments and royalties on sales of FDA approved products.
The Company's principal executive office and mailing address is 20
Kingsbridge Road, Piscataway, New Jersey 08054, and its telephone number is
(732) 980-4500.
The Offering
Securities Offered............ This Prospectus relates to an offering by the
Selling Stockholders of up to 150,000 shares of
Common Stock of the Company which are issuable
upon exercise of the Warrants held by the
Selling Stockholders.
Securities Outstanding........ As of December 18, 1997, the Company had
31,030,176 shares of Common Stock outstanding.
Assuming that the Warrants are exercised for the
maximum number of shares of Common Stock and no
other shares of Common Stock are issued
subsequent to December 18, 1997, the Company
would have 31,180,176 shares of Common Stock
outstanding. See "Selling Stockholders."
Use of Proceeds............... The Company will not receive any proceeds from
the sale of the Common Shares offered herein by
the Selling Stockholders. To date the Company
has not received any proceeds from the exercise
of the Warrants. If the Warrants are exercised
in their entirety the Company will receive
estimated gross proceeds of approximately
$375,000. The Company intends to utilize any
proceeds received from the exercise of the
Warrants for general corporate purposes. There
can be no assurance that the Warrants will be
exercised. See "Use of Proceeds."
Risk Factors.................. See "Risk Factors" for a discussion of certain
risk factors that should be considered by
prospective investors in connection with an
investment in the shares of Common Stock offered
hereby.
6
RISK FACTORS
Information contained and incorporated by reference in this Prospectus
contains "forward-looking statements" which can be identified by the use of
forward-looking terminology such as "believes," "expects," "may," "will,"
"should," or "anticipates" or the negative thereof or other variations thereon
or comparable terminology, or by discussions of strategy. No assurance can be
given that the future results covered by the forward-looking statements will be
achieved. The risk factors set forth below constitute cautionary statements
identifying important factors with respect to such forward-looking statements,
including certain risks and uncertainties, that could cause actual results to
vary materially from the future results indicated in such forward-looking
statements. Other factors could also cause actual results to vary materially
from the future results indicated in such forward-looking statements.
An investment in the Common Shares offered hereby involves a high degree of
risk. Prospective investors should carefully consider the following risk factors
in addition to the other information set forth and incorporated by reference in
this Prospectus before making any decision to invest in the Common Shares.
Accumulated Deficit and Uncertainty of Future Profitability. The Company was
originally incorporated in 1981. To date, the Company's sources of cash have
been the proceeds from the sale of its stock through public offerings and
private placements, sales of ADAGEN(R), sales of ONCASPAR(R), sales of its
products for research purposes, contract research and development fees,
technology transfer and license fees and royalty advances. At September 30,
1997, the Company had an accumulated deficit of approximately $112,510,000. To
date, ADAGEN and ONCASPAR are the only products of the Company which have been
approved for marketing by the FDA, having been approved in the United States in
March 1990 and February 1994, respectively. In 1993, the Company granted
exclusive U.S. marketing rights for ONCASPAR to RPR in consideration for which
the Company has received an aggregate of $6,000,000 of license fees. Under this
license agreement (the "Amended License Agreement"), the Company is entitled to
a base royalty of 23.5% until 2008. During 1995, RPR paid the Company $3,500,000
in advance royalties. Payments of base royalties under the Amended License
Agreement will be offset against a credit in the original amount of $5,970,000,
which represents the royalty advance plus reimbursement of certain amounts due
RPR under the original agreement and interest expense. Through September 30,
1997, an aggregate of $3,254,000 in royalties payable by RPR had been offset
against the original credit. The Company has also licensed ONCASPAR to RPR for
Canada and Mexico. Under this agreement, the Company is entitled to royalties
for sales of ONCASPAR in these territories. ONCASPAR was approved in Canada for
pediatric patients with ALL in November 1997. ONCASPAR is also currently
approved for marketing in Germany and Russia. The Company anticipates moderate
growth of ONCASPAR sales to RPR and Medac and increased royalties on RPR sales
of ONCASPAR; however, there can be no assurance that any particular sales level
of ONCASPAR will be achieved or maintained. During October 1996, the Company
entered into an exclusive license and marketing agreement for ONCASPAR in Europe
and Russia with Medac. Under the agreement, Medac purchases ONCASPAR from the
Company at set prices which increase over the term of the agreement. The
agreement also contains certain minimum annual purchase requirements. The
Company intends to pursue future licensing, marketing and development
arrangements that may result in additional fees to the Company prior to its
receiving revenues from commercial sales of its products which are sufficient
for the Company to earn a profit. There can be no assurance, however, that the
Company will be able to successfully consummate any such arrangements or receive
such fees in the future. Although the Company has been receiving reimbursement
from most third-party payors for ADAGEN, there can be no assurance that
reimbursement at these levels will continue. Lifetime limits on benefits which
are included in most private health insurance policies could permit insurers to
cease reimbursement for ADAGEN. Potential investors should be aware of the
difficulties a biopharmaceutical enterprise such as the Company encounters,
especially in view of the intense competition in the pharmaceutical industry in
which the Company competes. There can be no assurance that the Company's plans
will either materialize or prove successful, that its products under
7
development will be successfully developed or that its products will generate
revenues sufficient to enable the Company to earn a profit.
Need for Financing. The Company's current sources of liquidity are its cash
reserves, and interest earned on such cash reserves, sales of ADAGEN, sales of
ONCASPAR, sales of its products for research purposes, and license fees. There
can be no assurance as to the level of sales of the Company's FDA approved
products, ADAGEN and ONCASPAR, or the amount of royalties realized from the
commercial sale of ONCASPAR pursuant to the Company's license with RPR. Total
cash reserves, including short term investments, as of September 30, 1997, were
approximately $9,604,000. Management believes that the foregoing sources of
liquidity will be sufficient to meet the Company's anticipated cash
requirements, based on current spending levels, for approximately the next two
and one half years. The Company's continued operations thereafter will depend
upon its ability to (i) realize revenues from the commercial sale of its
products which are sufficient to cover its operating and capital expense
requirements, (ii) raise funds through equity or debt financing, or (iii) obtain
significant contract research and development fees or license fees. To the
extent the Company is unable to obtain funds, it may be required to curtail its
activities or sell additional securities. There can be no assurance that any of
the foregoing fund raising activities will successfully meet the Company's
anticipated cash needs.
Raw Materials and Dependence Upon Suppliers. Except for PEG hemoglobin, the
Company purchases from outside suppliers the unmodified compounds utilized in
its approved products and products under development. There can be no assurance
that the purified bovine hemoglobin used in the manufacture of PEG-hemoglobin
can be produced in the amounts necessary to expand the current clinical trials.
The Company may be required to obtain supply contracts with outside suppliers
for certain unmodified compounds. The Company does not produce the unmodified
adenosine deaminase used in the manufacture of ADAGEN or the unmodified forms of
L-asparaginase used in the manufacture of ONCASPAR and has a supply contract
with an outside supplier for each of these unmodified proteins. Delays in
obtaining or an inability to obtain any unmodified compound which the Company
does not produce, including unmodified adenosine deaminase, unmodified
L-asparaginase or unmodified bovine blood could have a material adverse effect
on the Company. In the event the Company is required to locate an alternate
supplier for an unmodified compound utilized in a product which is being sold
commercially or which is in clinical development, the Company will likely be
required to do additional testing, which could cause delays and additional
expenses, to demonstrate that the alternate supplier's material is biologically
and chemically equivalent to the unmodified compound previously used. Such
evaluations could include chemical, pre-clinical and clinical studies and could
delay development of a product which is in clinical trials, limit commercial
sales of an FDA approved product and cause the Company to incur significant
additional expense. Requirements for such evaluations would be determined by the
stage of the product's development and the reviewing division of the FDA. If
such alternate material is not demonstrated to be chemically and biologically
equivalent to the previously used unmodified compound, the Company will likely
be required to repeat some or all of the pre-clinical and clinical trials
conducted for such compound. The marketing of an FDA approved drug could be
disrupted while such tests are conducted. Even if the alternate material is
shown to be chemically and biologically equivalent to the previously used
compound, the FDA may require the Company to conduct additional clinical trials
with such alternate material.
Patents and Proprietary Technology. The Company has licensed, and been issued, a
number of patents in the United States and other countries and has other patent
applications pending to protect its proprietary technology. Although the Company
believes that its patents provide adequate protection for the conduct of its
business, there can be no assurance that such patents will be of substantial
protection or commercial benefit to the Company, will afford the Company
adequate protection from competing products, will not be challenged or declared
invalid, or that additional United States patents or foreign patent equivalents
will be issued to the Company. The degree of patent protection to be afforded to
biotechnological inventions is uncertain and the Company's products are subject
to this uncertainty. The Company is aware of certain issued patents and patent
applications, and there may be other patents and patent applications, containing
subject matter which the Company or its licensees or collaborators may require
in order to research, develop or commercialize at least
8
some of the Company's products. There can be no assurance that licenses under
such subject matter will be available on acceptable terms. The Company expects
that there may be significant litigation in the industry regarding patents and
other proprietary rights and, if Enzon were to become involved in such
litigation, it could consume a substantial amount of the Company's resources. In
addition, the Company relies heavily on its proprietary technologies for which
pending patent applications have been filed and on unpatented know-how developed
by the Company. Insofar as the Company relies on trade secrets and unpatented
know-how to maintain its competitive technological position, there can be no
assurance that others may not independently develop the same or similar
technologies. Although the Company has taken steps to protect its trade secrets
and unpatented know-how, third-parties nonetheless may gain access to such
information. Research Corporation Technologies, Inc. ("Research Corporation")
held the original patent upon which the PEG Process is based. Research
Corporation's patent in the United States and its patents in certain foreign
countries have expired. Although the Company has obtained several improvement
patents in connection with the PEG Process which it believes represent state of
the art technology, there can be no assurance that any of these patents will
enable the Company to prevent infringement or that competitors will not develop
competitive products outside the protection that may be afforded by these
patents. The Company is aware that others have also filed patent applications
and have been granted patents in the United States and other countries with
respect to the application of PEG to proteins. Based upon the expiration of the
Research Corporation patent, other parties will be permitted to make, use, or
sell products covered by the claims of the Research Corporation patent, subject
to other patents, including those held by the Company. The Company does not
believe that the expiration of the Research Corporation patent will have a
material adverse effect on the Company, but there can be no assurance that this
will be the case.
Marketing Uncertainties and Dependence on Marketing Partners. Other than ADAGEN,
which the Company markets on a worldwide basis to a small patient population,
the Company does not engage in the direct commercial marketing of any of its
products and therefore does not have an established sales force. For certain of
its products, the Company has provided exclusive marketing rights to its
corporate partners in return for royalties to be received on sales. With respect
to ONCASPAR, the Company has granted RPR exclusive marketing rights in North
America and Medac exclusive marketing rights in Europe and Russia. The Company
expects to retain marketing partners to market ONCASPAR in other foreign markets
and is currently pursuing arrangements in this regard. There can be no assurance
that such discussions will result in the Company concluding such arrangements.
Regarding the marketing of certain of the Company's other future products, the
Company expects to evaluate whether to create a sales force to market certain
products in the United States or to continue to enter into license and marketing
agreements with others for United States and foreign markets. These agreements
generally provide that all or a significant portion of the marketing of these
products will be conducted by the Company's licensees or marketing partners. In
addition, under certain of these agreements, the Company's licensee or marketing
partner may have all or a significant portion of the development and regulatory
approval responsibilities. Should the licensee or marketing partner fail to
develop a marketable product (to the extent it is responsible for product
development) or fail to market a product successfully, if it is developed, the
Company's business may be adversely affected. There can be no assurance that the
Company's marketing strategy will be successful. Under the Company's marketing
and license agreements, the Company's marketing partners and licensees may have
the right to terminate the agreement and abandon the product at any time for any
reason without significant payments. The Company is aware that certain of its
marketing partners are pursuing parallel development of products on their own
and with other collaborative partners which may compete with the licensed
products and there can be no assurance that the Company's other current or
future marketing partners will not also pursue such parallel courses.
Reimbursement from Third-Party Payors. Sales of the Company's products will be
dependent in part on the availability of reimbursement from third-party payors,
such as governmental health administration authorities, private health insurers
and other organizations. There can be no assurance that such reimbursement will
be available or will permit the Company to sell its products at price levels
sufficient for it to realize an appropriate return on its investment in product
development. Since patients who receive
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ADAGEN will be required to do so for their entire lives (unless a cure or
another treatment is developed), lifetime limits on benefits which are included
in most private health insurance policies could permit insurers to cease
reimbursement for ADAGEN.
Government Regulation. The manufacturing and marketing of pharmaceutical
products in the United States is subject to stringent governmental regulation
and the sale of any of the Company's products for use in humans in the United
States will require the prior approval of the FDA. Similar approvals by
comparable agencies are required in most foreign countries. The FDA has
established mandatory procedures and safety standards which apply to the
clinical testing, manufacture and marketing of pharmaceutical products.
Pharmaceutical manufacturing facilities are also regulated by state, local and
other authorities. Obtaining FDA approval for a new therapeutic may take several
years and involve substantial expenditures. ADAGEN was approved by the FDA in
March 1990. ONCASPAR was approved by the FDA in February 1994 and in Germany in
November 1994 for patients with acute lymphoblastic leukemia who are
hypersensitive to native forms of L-asparaginase. ONCASPAR has been approved for
broader indications in Russia and Canada in April 1993 ONCASPAR was approved for
therapeutic use in a broad range of cancers in Russia, and in Canada for
patients who have been diagnosed with ALL during their childhood. Except for
these approvals, none of the Company's other products have been approved for
sale and use in humans in the United States or elsewhere. There can be no
assurance that the Company will be able to obtain FDA approval for any of its
other products. Failure to obtain requisite governmental approvals or failure to
obtain approvals of the scope requested, will delay or preclude the Company or
its licensees or marketing partners from marketing their products, or limit the
commercial use of the products, and thereby may have a material adverse affect
on the Company's liquidity and financial condition.
Intense Competition and Risk of Technological Obsolescence. Many established
biotechnology and pharmaceutical companies with resources greater than those of
the Company are engaged in activities that are competitive with Enzon's and may
develop products or technologies which compete with those of the Company.
Although Enzon is not aware of any competitor which has achieved the same level
as the Company in utilizing PEG technology in developing drug products, it is
aware of other companies which are engaged in this field and there can be no
assurance that competitors will not successfully develop such products in the
future. Although there are other companies engaged in the development of
Single-Chain Antigen-Binding (SCA(R)) proteins, Enzon believes that these
companies will be required to obtain a license under Enzon's SCA patents in
order to commercialize any such product. There can be no assurance, however,
that this will prove to be the case. Rapid technological development by others
may result in the Company's products becoming obsolete before the Company
recovers a significant portion of the research, development and
commercialization expenses incurred with respect to those products. Enzon
believes that the experience of certain of its personnel in research and
development, and its patents and proprietary know-how may provide it with a
competitive advantage in its field; however, there can be no assurance that the
Company will be able to maintain such a competitive advantage, should it exist,
in view of the greater size and resources of many of its competitors. Other
drugs or treatment modalities which are currently available or that may be
developed in the future, and which treat the same diseases as those which the
Company's products are designed to treat, may be competitive with the Company's
products.
Potential Product Liability. The use of the Company's products during testing or
after regulatory approval entails an inherent risk of adverse effects which
could expose the Company to product liability claims. The Company maintains
product liability insurance coverage in the total amount of $10,000,000 for
claims arising from the use of its products in clinical trials prior to FDA
approval and for claims arising from the use of its products after FDA approval.
There can be no assurance that the Company will be able to maintain its existing
insurance coverage or obtain coverage for the use of its other products in the
future. Management believes that the Company maintains adequate insurance
coverage for the operation of its business at this time; however, there can be
no assurance that such insurance coverage and the resources of the Company would
be sufficient to satisfy any liability resulting from product liability claims.
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Dividend Policy and Restrictions. The Company has paid no dividends on its
Common Stock, since its inception and does not plan to pay dividends on its
Common Stock in the foreseeable future. Except as may be utilized to pay the
dividends payable on the Company's Series A Cumulative Convertible Preferred
Stock (the "Series A Preferred Stock"), any earnings which the Company may
realize will be retained to finance the growth of the Company. In addition, the
terms of the Series A Preferred Stock restrict the payment of dividends on other
classes and series of stock.
Possible Volatility of Stock Price. Since the Company's initial public offering,
the market price of the Company's Common Stock has fluctuated over a wide range
and it is likely that the price of the Common Stock will fluctuate in the
future. Announcements regarding technical innovations, the development of new
products, the status of corporate collaborations and supply arrangements,
regulatory approvals, patent or proprietary rights or other developments by the
Company or its competitors could have a significant impact on the market price
of the Common Stock.
USE OF PROCEEDS
The Company will not receive any proceeds from the sale of the Common
Shares offered herein by the Selling Stockholders. To date the Company has not
received proceeds from the exercise of the Warrants. If the Warrants are
exercised in their entirety the Company will receive estimated gross proceeds of
approximately $375,000. The Company intends to utilize any proceeds received
from the exercise of the Warrants for general corporate purposes. There can be
no assurance that the Warrants will be exercised.
SELLING STOCKHOLDERS
General
In August 1995, the Company issued Warrants for the purchase of (i) up to
112,500 Warrant Shares to Edward S. Gordon Company ("ESG"), and (ii) up to
37,500 Warrant Shares to The Pyne Companies ("Pyne", and together with ESG
collectively referred to herein as the "Selling Stockholders"), in connection
with certain real estate consulting services provided by each of ESG and Pyne to
the Company. Pursuant to the terms of the Warrants, the Company is required to
file a registration statement for the registration of the Warrant Shares
issuable upon exercise of the Warrants by ESG and Pyne. The 150,000 Warrant
Shares are being offered by the Selling Stockholders hereby.
The Company has agreed to indemnify the Selling Stockholders against any
liabilities, under the Securities Act or otherwise, arising out of or based upon
any untrue or alleged untrue statement of a material fact in the Registration
Statement or this Prospectus or by any omission of a material fact required to
be stated therein except to the extent that such liabilities arise out of or are
based upon any untrue or alleged untrue statement or omission in any information
furnished in writing to the Company by the Selling Stockholders expressly for
use in the Registration Statement. Insofar as indemnification for liabilities
arising under the Securities Act may be permitted to directors, officers or
persons controlling the Company pursuant to its certificate of incorporation and
by-laws, the Company has been informed that in the opinion of the Securities and
Exchange Commission such indemnification is against public policy as expressed
in the Act and is therefore unenforceable.
In connection with the registration of the shares of Common Stock offered
hereby, the Company will supply prospectuses to the Selling Stockholders.
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Stock Ownership
The table below sets forth (i) the number of shares of Common Stock owned
beneficially by the Selling Stockholders prior to the Offering; (ii) the number
of shares of Common Stock being offered by the Selling Stockholders pursuant to
this Prospectus; (iii) the number of shares of Common Stock to be owned
beneficially by the Selling Stockholders after completion of the offering,
assuming that all of the Common Shares offered hereby are sold; and (iv) the
percentage of the outstanding shares of Common Stock to be owned beneficially by
the Selling Stockholders after completion of the offering, assuming that all of
the Common Shares offered hereby are sold. Other than the transactions described
herein, the Selling Stockholders have not had any material relationship with the
Company during the past three years.
Number of Percentage of
Shares to be Outstanding Shares
Number of Owned of Common Stock
Shares Beneficially to be Owned
Beneficially Number of After Beneficially After
Selling Owned Prior Shares Completion Completion
Stockholders to Offering Offered of Offering of Offering(1)
------------ ----------- ------- ----------- --------------
Edward S. Gordon 0 112,500(3) -0- *
Company(2)
The Pyne Companies(2) 0 37,500(3) -0- *
(1) Based upon shares of Common Stock outstanding as of December 18, 1997.
(2) In connection with the termination of certain leases, the Company issued in
August 1995, as part of the commission due to ESG and Pyne, the Company's
real estate brokers, an aggregate of 150,000 five-year warrants to purchase
the Company's Common Stock at $2.50 per share.
(3) To be issued upon exercise of the Warrants.
* Less than 1%.
The Company has agreed to bear certain expenses (other than broker
discounts and commissions, if any, and expenses of counsel and other advisors to
certain of the Selling Stockholders) in connection with the registration of the
Common Shares.
PLAN OF DISTRIBUTION
The Common Shares may be sold pursuant to this Prospectus by the Selling
Stockholders. Assuming all Warrants are exercised, the Company will receive
aggregate proceeds from the issuance of such shares to the Selling Stockholders
in the amount of approximately $375,000. These sales may occur in privately
negotiated transactions or in the over-the-counter market or a combination of
such methods of sale, at fixed prices which may be changed, at market prices
prevailing at the time of sale, at prices related to prevailing market prices or
at negotiated prices. The Company has been advised by the Selling Stockholders
that they have not made any arrangements relating to the distribution of the
shares of Common Stock covered by this Prospectus. In effecting sales,
broker-dealers engaged by the Selling
12
Stockholders may arrange for other broker-dealers to participate. Broker-dealers
will receive commissions or discounts from the Selling Stockholders in amounts
to be negotiated immediately prior to the sale. In order to comply with the
securities laws of certain states, if applicable, the Common Shares will be sold
in such jurisdictions only through registered or licensed brokers or dealers. In
addition, in certain states the Common Shares may not be sold unless they have
been registered or qualified for sale in the applicable state or an exemption
from the registration or qualification requirement is available and is complied
with by the Company and the Selling Stockholders.
The Selling Stockholders and any broker-dealers who execute sales for the
Selling Stockholders may be deemed to be "underwriters" within the meaning of
the Securities Act by virtue of the number of shares of Common Stock to be sold
or resold by such persons or entities or the manner of sale thereof, or both. If
the Selling Stockholders, broker-dealers or other holders were determined to be
underwriters, any discounts or commissions received by them or by brokers or
dealers acting on their behalf and any profits received by them on the resale of
their shares of Common Stock might be deemed underwriting compensation under the
Securities Act.
The Selling Stockholders have represented to the Company that any purchase
or sale of the Common Stock by it will be in compliance with applicable rules
and regulations of the Commission.
Under applicable rules and regulations under the Exchange Act, any person
engaged in the distribution of the Common Shares may not simultaneously engage
in market making activities with respect to the Common Stock of the Company for
a period of two business days prior to the commencement of such distribution. In
addition and without limiting the foregoing, the Selling Stockholders will be
subject to applicable provisions of the Exchange Act and the rules and
regulations thereunder, including, without limitation, Regulation M, which
provisions may limit the timing of purchases and sales of shares of the
Company's Common Stock by the Selling Stockholders.
The Company has agreed to register the Common Shares under the Securities
Act and to bear certain expenses (other than selling commissions) in connection
with such registration and to indemnify and hold certain of the Selling
Stockholders harmless against certain liabilities under the Securities Act that
could arise in connection with the sale by such Selling Stockholders of the
Common Shares.
There can be no assurance that the Selling Stockholders will sell all or
any of the Common Shares offered hereby.
LEGAL MATTERS
The legality of the shares of Common Stock offered hereby has been passed
on for the Company by Dorsey & Whitney LLP, New York, New York.
EXPERTS
The consolidated financial statements of Enzon, Inc. and subsidiaries as of
June 30, 1997 and 1996 and for each of the years in the three-year period ended
June 30, 1997, have been incorporated by reference herein and in the
Registration Statement in reliance upon the report of KPMG Peat Marwick LLP,
independent certified public accountants, incorporated by reference herein, and
upon the authority of said firm as experts in accounting and auditing.
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