PROSPECTUS
ENZON, INC.
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2,051,851 Shares
Common Stock
($.01 par value)
This prospectus (the "Prospectus") relates to the offer and sale of up
to 2,051,851 shares of common stock, $.01 par value (the "Common Stock"), of
Enzon Inc. (the "Company" or "Enzon") by a selling stockholder (the "Selling
Stockholder"). Of such 2,051,851 shares of Common Stock (i) an aggregate of
1,015,228 shares were issued upon conversion of 20,000 shares of the Company's
Series D Convertible Preferred Stock, $.01 par value (the "Series D Preferred
Shares"); (ii) 200,000 shares (the "Warrant Shares") are issuable upon exercise
of an outstanding amended and restated warrant (the "Warrant") held by the
Selling Stockholder and (iii) up to 836,623 shares (the "Additional Shares") are
additional shares which may be issued to the Selling Stockholder pursuant to the
Certificate of Designations, Rights and Preferences relating to the Series D
Preferred Shares (the "Certificate of Designations"), upon the occurrence of
certain events, as hereinafter described (each a "Certificate of Designations
Triggering Event") and/or pursuant to the Registration Rights Agreement (the
"Registration Rights Agreement") entered into by the Company and the Selling
Stockholder in connection with the Private Placement (as hereinafter defined),
as amended by the Stock Exchange Agreement (as hereinafter defined), upon the
occurrence of certain events, as hereinafter described (each a "Registration
Rights Triggering Event," with the Certificate of Designation Triggering Event
and the Registration Rights Triggering Event being hereinafter sometimes
referred to as the "Triggering Event").
In a private placement transaction which closed March 15, 1996 (the
"Private Placement"), the Selling Stockholder purchased 266,667 shares of Common
Stock, and 20,000 shares of the Company's Series C Convertible Preferred Stock
(the "Series C Preferred Shares"), and was issued a warrant for no separate
consideration to purchase 200,000 shares of Common Stock. Pursuant to the terms
of a Stock Exchange Agreement dated as of February 28, 1997 (the "Stock Exchange
Agreement"), the Selling Stockholder exchanged the Series C Preferred Shares for
an equal number of Series D Preferred Shares and exchanged such warrant for the
Warrant. Immediately following the exchange, the Selling Stockholder converted
the Series D Preferred Shares into 1,015,228 shares of Common Stock. The shares
of Common Stock received by the Selling Stockholder upon the conversion of the
Series D Preferred Shares and the shares of Common Stock to be received upon
exercise of the Warrant are being offered by the Selling Stockholder hereby. The
Warrant is exercisable at a per share exercise price of $5.625 (as may be
adjusted in accordance with the terms of the Warrant commencing on May 16, 1996,
and expires on March 15, 2001.) The Common Stock received upon conversion of the
Series D Preferred Shares, the Warrant Shares and the Additional Shares are
collectively referred to herein as the "Common Shares."
The Certificate of Designations Triggering Events include, among other
things, the failure of the Company to file a registration statement relating to
the shares of Common Stock issued upon conversion of the Series D Preferred
Shares by a specified date, the failure to maintain the effectiveness of the
registration statement for the period required, or the failure of the Company to
maintain the listing of the Common Stock on the Nasdaq National Market, Nasdaq
Smallcap Market or other specified national securities exchanges. The actual
number of shares to be issued upon the occurrence of a Certificate of
Designations Triggering Event is based on a formula contained in the Certificate
of Designations which takes into account the duration of the Triggering Event.
Pursuant to the terms of the Registration Rights Agreement, the Company
may be required to issue an indeterminate number of additional shares of Common
Stock upon the occurrence of a Registration Rights Triggering Event. The
Registration Rights Triggering Events are substantially identical to the
Certificate of Designations Triggering Events. Up to a maximum of 836,623 of the
Shares of Common Stock to be received upon the occurrence of a Triggering Event
are being offered by the Selling Stockholder hereby. In the event the
Company is required to issue in excess of 836,623 shares of its Common Stock
upon the occurrence of a Triggering Event, the Company may be required to file
an additional registration statement to cover such additional shares. See "Risk
Factors - Possible Volatility of Stock Price" and "Selling Stockholder."
The Selling Stockholder 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 Stockholder 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 Stockholder 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. See "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 $35,000. The
Selling Stockholder 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 $1,125,000 upon exercise of the Warrant. 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 July 22,
1997 the reported last sale price of the Common Stock, as reported on the Nasdaq
National Market was $2.625 per share.
AN INVESTMENT IN THE SECURITIES OFFERED HEREBY INVOLVES A HIGH DEGREE OF RISK.
SEE "RISK FACTORS" COMMENCING ON PAGE 6.
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 August 14, 1997
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TABLE OF CONTENTS
Page
Available Information........................................... 1
Incorporation of Certain Documents by Reference................. 1
Prospectus Summary.............................................. 3
Risk Factors.................................................... 6
Use of Proceeds................................................. 10
Selling Stockholder............................................. 10
Plan of Distribution............................................ 11
Legal Matters................................................... 12
Experts......................................................... 12
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. 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.
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AVAILABLE INFORMATION
The Company is subject to the informational requirements of the
Securities Exchange Act of 1934, as amended (the "Exchange Act"), and in
accordance therewith files reports, proxy statements and other information with
the Securities and Exchange 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 Company's Securities are 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 (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. 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 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, 1996, 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 3, 1996 (ii) all other reports filed by
the Company pursuant to Section 13(a) or 15(d) of the Exchange Act since June
30, 1996, including but not limited to, the Quarterly Report on Form 10-Q for
the Quarter Ended September 30, 1996, the Quarterly Report on Form 10-Q for the
Quarter Ended December 31, 1996, the Quarterly Report on Form 10-Q for the
Quarter Ended March 31, 1997, and the Current Reports on Form 8-K filed by the
Company with the Commission on each of July 22, 1996, November 4, 1996, December
20, 1996, January 16, 1997, January 27, 1997, February 28, 1997, and March 10,
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.
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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
and incorporated by reference in this Prospectus.
The Company
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 has received marketing approval from the United States Food
and Drug Administration ("FDA") for two of its products: (i) ONCASPAR(R),
approved in February 1994 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, approved in March 1990, to treat a rare form of Severe
Combined Immunodeficiency Disease ("SCID"), commonly known as the "Bubble Boy
Disease".
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 received $6,000,000
from RPR related to the granting of the U.S. license and is also entitled to
royalties on the sales of ONCASPAR in the U.S. by RPR of 23.5% to 43.5%, based
on the sales level of ONCASPAR. Royalties payable to the Company by RPR are
being offset against an original credit of $5,970,000, which includes $3,500,000
in advance royalties received by the Company in fiscal 1995. In October 1996,
the Company entered into a marketing agreement with Medac for ONCASPAR in Europe
and Russia. Medac will purchase ONCASPAR from Enzon at a set price which will
increase over the term of the agreement. The agreement also contains certain
minimum annual purchase requirements. The Company has also granted exclusive
licenses to sell ONCASPAR in Canada and Mexico to RPR in exchange for royalty
payments on future sales and is currently pursuing additional licenses for
marketing and distribution rights outside North America, Europe and Russia. RPR
and Medac are currently conducting clinical trials in expanded indications for
ONCASPAR.
ONCASPAR is the enzyme L-asparaginase modified by the Company's PEG
Process and ADAGEN is the enzyme adenosine deaminase modified by the Company's
PEG Process. 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, thereby 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 December
1996. The Company has made significant improvements to the original PEG Process
and has applied for and received several patents for such improvements.
The Company recently has developed technology that gives PEG-modified
compounds "Pro Drug" attributes. This is accomplished by attaching PEG by means
of a covalent bond that is designed to deteriorate over time, thereby releasing
the therapeutic moiety (therapeutic part of the compound) in the proximity of
the target tissue. These attributes could significantly enhance the therapeutic
value of new chemicals, as well as drugs already marketed. The Company believes
that this "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
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these drugs and biologicals have large potential patient populations. The
Company is currently applying its Pro Drug/Transport Technology to certain
anticancer agents that are in the early research stage.
The Company's lead development candidate, PEG-hemoglobin, is a
hemoglobin-based oxygen carrier, commonly referred to as a red blood cell
substitute, and is currently being developed by the Company as a radiosensitizer
for use with radiation treatment of solid hypoxic tumors. Preclinical studies
conducted at Enzon, the University of Wisconsin School of Veterinary Medicine
and Dana Farber Cancer Institute, indicate that 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.
During fiscal 1996, the Company completed a Phase I safety study for
PEG-hemoglobin in which 34 normal volunteers received a single dose of
PEG-hemoglobin in amounts up to 45 grams, the equivalent of 1.5 units of whole
blood. The Company is currently conducting a multi-dose, multi-center clinical
trial of PEG-hemoglobin in cancer patients receiving radiation treatment.
Patients entering this new trial receive once-a-week infusions of PEG-
hemoglobin followed by five days of radiation treatment. The protocol for this
study calls for this to be repeated weekly for three weeks. The primary purpose
of this trial is to evaluate safety related to multiple doses of PEG- hemoglobin
and radiation therapy. It is estimated that approximately 800,000 cases of solid
hypoxic tumors are diagnosed each year in the United States.
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.
One such license is the Company's agreement with Schering Corporation
("Schering") to apply the PEG Process to Schering's product, INTRON A(R)
(interferon alfa 2b), a genetically-engineered anticancer-antiviral drug.
Schering has reported that the PEG-modified version of INTRON A is currently in
clinical trials. Under the agreement, the Company is entitled to royalties on
worldwide sales of PEG-INTRON A, if any, and payments of approximately
$5,500,000 subject to the achievement of certain milestones in the product's
development. Sales by Schering of the unmodified version of INTRON A were
reported as $524 million for 1996. The Company has the option, upon FDA
approval, to be Schering's exclusive manufacturer of PEG-INTRON A for the U.S.
market.
The Company also has an extensive licensing program for its SCA protein
technology. SCA proteins are genetically engineered proteins designed to
overcome the problems hampering the diagnostic and therapeutic use of
conventional monoclonal antibodies. Pre-clinical 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 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 Phase II clinical
trials by various institutions, including a product developed by the Company,
SCA-CC49. 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, Inc. ("Bristol-Myers"), Baxter
Healthcare Corporation ("Baxter"), Eli Lilly & Co. ("Eli Lilly") 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.
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The Offering
Securities Offered.......
This Prospectus relates to an offering by the Selling Stockholder of
up to 2,051,851 shares of Common Stock of the Company. Of these shares (i)
1,015,228 shares are Common Shares which were issued upon conversion of the
Series D Preferred Shares; (ii) 200,000 shares are Warrant Shares which may
be issued upon exercise of the Warrant issued to the Selling Stockholder
and (iii) 836,623 shares are Additional Shares which may be issued to the
Selling Stockholder upon the occurrence of a Triggering Event. The actual
number of shares of Common Stock issued to the Selling Stockholder and sold
hereby will depend upon whether a Triggering Event occurs and the duration
of such Triggering Event. The Company believes that the number of shares of
Common Stock to which this Prospectus relates should be the maximum number
of shares of Common Stock that are likely to be issued to the Selling
Stockholder and sold hereby, and expects that the actual number of shares
of Common Stock issued to the Selling Stockholder and sold hereby will be
less than such number. See "Risk Factors - Possible Volatility of Stock
Price" and "Selling Stockholder."
Securities Outstanding...
As of July 1, 1997, the Company had 30,797,735 shares of Common Stock
outstanding. Assuming that the Warrant is exercised for the maximum number
of shares of Common Stock and no Triggering Event occurs and no other
shares of Common Stock are issued subsequent to June 30, 1997, the Company
would have 30,997,735 shares of Common Stock outstanding. See "Selling
Stockholder."
Use of Proceeds.........
The Company will not receive any proceeds from the sale of the Common
Shares offered herein by the Selling Stockholder. To date the Company has
not received any proceeds from the exercise of the Warrant. If the Warrant
is exercised in its entirety the Company will receive estimated gross
proceeds of approximately $1,125,000. The Company intends to utilize any
proceeds received from the exercise of the Warrant for general corporate
purposes. There can be no assurance that the Warrant 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.
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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 March 31, 1997,
the Company had an accumulated deficit of approximately $108,636,000. 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 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 March 31, 1997,
an aggregate of $2,073,000 in royalties payable by RPR had been offset against
the original credit. ONCASPAR is also currently approved for marketing in
Germany and Russia. The Company has granted marketing rights to ONCASPAR to
Medac for Europe and Russia. Medac will purchase ONCASPAR from Enzon at a set
price which will increase over the term of the marketing agreement. The
agreement also contains certain minimum purchase requirements. 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. 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 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
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Company's license with RPR. Total cash reserves, including short term
investments, as of March 31, 1997, were approximately $9,597,000. 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 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. The Company is currently producing
many of the unmodified compounds utilized in products it has under development,
including purified bovine hemoglobin for use in its PEG-hemoglobin product.
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 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 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.
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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 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
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acute lymphoblastic leukemia who are hypersensitive to native forms of
L-asparaginase, and in Russia in April 1993 for therapeutic use in a broad range
of cancers. 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.
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. Historically, 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.
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USE OF PROCEEDS
The Company will not receive any proceeds from the sale of the Common
Shares offered herein by the Selling Stockholder. To date the Company has not
received proceeds from the exercise of the Warrant. If the Warrant is exercised
in its entirety the Company will receive estimated gross proceeds of
approximately $1,125,000. The Company intends to utilize any proceeds received
from the exercise of the Warrant for general corporate purposes. There can be no
assurance that the Warrant will be exercised.
SELLING STOCKHOLDER
General
The Selling Stockholder purchased 266,667 shares of Common Stock and
20,000 shares of Series C Preferred Shares and was issued a warrant for no
separate consideration to purchase 200,000 shares of Common Stock in the Private
Placement. Pursuant to the Stock Exchange Agreement, the Selling Stockholder
exchanged the Series C Preferred Shares for an equal number of Series D
Preferred Shares and such Series D Preferred Shares were converted into
1,015,228 shares of Common Stock.
Pursuant to the Certificate of Designations and/or the Registration
Rights Agreement, the Company may be required to issue additional shares of
Common Stock upon the occurrence of a Triggering Event. The Certificate of
Designations Triggering Events include, among other things, the failure of the
Company to file a registration statement relating to the shares of Common Stock
issued upon conversion of the Series D Preferred Shares by a specified date, the
failure to maintain the effectiveness of the registration statement for the
period required, or the failure of the Company to maintain the listing of the
Common Stock on the Nasdaq National Market, Nasdaq Smallcap Market or other
specified national securities exchanges. The actual number of shares to be
issued upon the occurrence of a Certificate of Designations Triggering Event is
based on a formula contained in the Certificate of Designations which takes into
account the duration of the Triggering Event.
Pursuant to the terms of the Registration Rights Agreement, the Company
may be required to issue an indeterminate number of additional shares of Common
Stock upon the occurrence of a Registration Rights Triggering Event. The
Registration Rights Triggering Events are substantially identical to the
Certificate of Designations Triggering Events. Up to a maximum of 836,623 shares
of Common Stock to be issued upon the occurrence of a Triggering Event may be
offered and sold by the Selling Stockholder pursuant hereto. In the event the
Company is required to issue more than 836,623 shares of Common Stock upon the
occurrence of a Triggering Event, the Company may be required to file an
additional registration statement to cover such additional shares.
The Company has agreed to indemnify the Selling Stockholder 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 Stockholder 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 Stockholder.
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Stock Ownership
The table below sets forth (i) the number of shares of Common Stock
owned beneficially by the Selling Stockholder prior to the Offering (assuming no
shares are issued upon the occurrence of a Registration Rights Triggering
Event); (ii) the number of shares of Common Stock being offered by the Selling
Stockholder pursuant to this Prospectus; (iii) the number of shares of Common
Stock to be owned beneficially by the Selling Stockholder 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 Stockholder after completion of the offering,
assuming that all of the Common Shares offered hereby are sold. Other than the
transactions described herein, the Selling Stockholder has 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
Owned Prior Shares Completion Completion
Selling Stockholder to Offering Offered of Offering of Offering(1)
Clearwater Fund IV Limited 2,359,108(2) 1,215,228(3) 1,143,880 3.714%
(1) Based upon shares of Common Stock outstanding as of July 1, 1997.
(2) Does not include shares of Common Stock to be issued upon the occurrence of
a Triggering Event, if any. Includes 200,000 to be issued upon exercise of
the Warrant.
(3) Does not include shares of Common Stock to be issued upon the occurrence of
a Triggering Event, if any.
PLAN OF DISTRIBUTION
The Common Shares may be sold pursuant to this Prospectus by the
Selling Stockholder. These sales may occur in privately negotiated transactions
or in the over-the-counter market through brokers and dealers as agents or to
brokers and dealers as principals, who may receive compensation in the form of
discounts or commissions from the Selling Stockholder or from the purchasers of
the Common Stock for whom the broker-dealers may act as agent or to whom they
may sell as principal, or both. The Company has been advised by the Selling
Stockholder 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 Stockholder may arrange
for other broker-dealers to participate. Broker-dealers will receive commissions
or discounts from the Selling Stockholder in amounts to be negotiated
immediately prior to the sale.
The Selling Stockholder and any broker-dealers who execute sales for
the Selling Stockholder 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 Stockholder, 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 Stockholder has 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.
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LEGAL MATTERS
The legality of the shares of Common Stock offered hereby has been
passed on for the Company by Ross & Hardies, New York, New York.
EXPERTS
The consolidated financial statements of Enzon, Inc. and subsidiaries
as of June 30, 1996 and 1995 and for each of the years in the three-year period
ended June 30, 1996, 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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