SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) May 17, 2002
ENZON, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-12957 22-2372868
(State or other jurisdiction of (Commission (IRS Employer
incorporation) File Number) Identification)
20 Kingsbridge Road, Piscataway, New Jersey 08854
(Address of principal executive offices) (Zip Code)
(Registrant's telephone number, including area code: (732) 980-4500
NA
(Former name or former address, if changed since last report)
Item 5. Other Events
Stockholders' Rights Plan and Amendments to Bylaws
On May 17, 2002 the Board of Directors of Enzon, Inc. (the "Company"), declared
a dividend of one preferred share purchase right (a "Right") per share for each
outstanding share of Common Stock, par value $0.01 (the "Common Shares"), of the
Company. The dividend will be payable on June 3, 2002 (the "Record Date") to
holders of the Common Shares of record on that date.
Each Right entitles the registered holder to purchase from the Company one
one-thousandth of a share of Series B Preferred Stock, par value $0.01 (the
"Preferred Shares"), of the Company at a price of $190.00 per one one-thousandth
of a Preferred Share (the "Purchase Price"), subject to adjustment; provided,
however, under the circumstances described below, holders may receive Common
Shares instead of Preferred Shares. The description and terms of the Rights are
set forth in the Rights Agreement, dated as of May 17, 2002 (the "Rights
Agreement"), between the Company and Continental Stock Transfer & Trust Company,
as Rights Agent (the "Rights Agent").
The following summary of the principal terms of the Rights Agreement is a
general description only and is subject to the detailed terms and conditions of
the Rights Agreement. A copy of the Rights Agreement is filed as an exhibit to
this Form 8-K and is incorporated herein by reference. Capitalized terms used
herein but not defined shall have the meaning assigned to them in the Rights
Agreement.
Initially, the Rights will attach to all certificates representing Common Shares
then outstanding and no separate Right Certificates (as defined herein) will be
distributed. The Rights will separate from the Common Shares, and a Distribution
Date for the Rights will occur upon the earlier of:
(i) the close of business on the day following a public announcement
that a person or group of affiliated or associated persons has become an
"Acquiring Person" (i.e., has become, subject to certain exceptions, the
Beneficial Owner of 15% (the "Threshold Percentage") or more of the
outstanding Common Shares); and
(ii) the close of business on the day following the commencement or
public announcement of the intention to commence a tender offer or
exchange offer, the consummation of which would result in a person or
group of affiliated or associated persons becoming, subject to certain
exceptions, the Beneficial Owner of the Threshold Percentage or more of
the outstanding Common Shares (or such later date as may be determined by
the Board of Directors of the Company prior to a person or group of
affiliated or associated persons becoming an Acquiring Person).
A Person will not be an Acquiring Person if the Board of Directors of the
Company determines that such Person became the Beneficial Owner of the Threshold
Percentage or more of the Common Shares of the Company then outstanding
inadvertently and such Person divests itself, within a reasonable period of time
as determined by the Board of Directors, of a sufficient number of Common Shares
so that such Person is no longer the Beneficial Owner of the Threshold
Percentage or more of the Common Shares of the Company then outstanding.
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Until the Distribution Date,
(i) the Rights will be evidenced by the Common Share certificates
and will be transferred with and only with the Common Shares,
(ii) new Common Share certificates issued after the Record Date upon
transfer or new issuance of the Common Shares will contain a notation
incorporating the Rights Agreement by reference, and
(iii) the surrender for transfer of any Common Share certificate,
even without such notation or a copy of the Summary of Rights distributed
to stockholders of record as of the Record Date, also will constitute the
transfer of the Rights associated with the Common Shares represented by
such certificate.
As promptly as practicable following the Distribution Date, separate
certificates evidencing the Rights ("Right Certificates") will be mailed to
holders of record of the Common Shares as of the close of business on the
Distribution Date, and such separate Right Certificates alone will evidence the
Rights.
The Rights are not exercisable until the Distribution Date. The Rights will
expire on May 16, 2012, unless extended or earlier redeemed or exchanged by the
Company as described below.
The Purchase Price payable, and the number of Preferred Shares or other
securities or property issuable upon exercise of the Rights, are subject to
adjustment from time to time to prevent dilution:
(i) in the event of a stock dividend on, or a subdivision,
combination or reclassification of, the Preferred Shares,
(ii) upon the grant to holders of the Preferred Shares of certain
rights, options or warrants to subscribe for or purchase Preferred Shares
or securities convertible into Preferred Shares or preferred share
equivalents at less than the then current market price of the Preferred
Shares, or
(iii) upon the distribution to holders of the Preferred Shares of
evidences of indebtedness or assets (excluding regular periodic cash
dividends or dividends payable in Preferred Shares) or of subscription
rights or warrants (other than those described in clause (ii) of this
paragraph).
With certain exceptions, no adjustment in the Purchase Price will be required
until cumulative adjustments require an adjustment of at least 1% in the
Purchase Price. No fraction of a Preferred Share will be issued (other than
fractional shares which are integral multiples of one one-thousandth of a
Preferred Share, which may, at the election of the Company, be evidenced by
depositary receipts) if in lieu thereof, a payment in cash is made based on the
closing price (prorated for the fraction) of a Preferred Share on the last
trading date prior to the date of exercise.
The number of outstanding Rights and the number of one one-thousandths of a
Preferred Share issuable upon exercise of each Right also are subject to
adjustment in the event of a stock split of the Common Shares, a stock dividend
on the Common Shares payable in Common Shares, or
3
subdivisions, consolidations or combinations of the Common Shares occurring, in
any such case, prior to the Distribution Date.
Preferred Shares purchasable upon exercise of the Rights will not be redeemable.
Each Preferred Share will be entitled to a minimum preferential quarterly
dividend payment of the greater of (a) $1.00 or (b) subject to the provision for
adjustment, 1,000 times the aggregate per share amount of all cash dividends,
and 1,000 times the aggregate per share amount (payable in kind) of all non-cash
dividends or other distributions declared on the Common Shares since the
immediately preceding Quarterly Dividend Payment Date or, with respect to the
first Quarterly Dividend Payment Date, since the first issuance of any share or
fraction of a share of the Preferred Shares. In the event of liquidation, the
holders of the Preferred Shares would be entitled to receive a preferential
liquidation payment of the greater of (i) $1,000 per share, plus an amount equal
to accrued and unpaid dividends and distributions thereon, whether or not
declared, to the date of such payment, or (ii) an aggregate amount per share,
subject to the provision for adjustment hereinafter set forth, equal to 1,000
times the aggregate amount to be distributed per share to holders of Common
Shares, or to the holders of shares of stock ranking on a parity (either as to
dividends or upon liquidation, dissolution or winding up) with the Preferred
Shares. Each Preferred Share will have 1,000 votes, voting together with the
Common Shares. Finally, in the event of any merger, consolidation or other
transaction in which Common Shares are exchanged, each Preferred Share will be
entitled to receive 1,000 times the amount received per Common Share. These
rights are protected by customary antidilution provisions.
Because of the nature of the Preferred Shares' dividend, liquidation and voting
rights, the value of the one one-thousandth interest in a Preferred Share
purchasable upon exercise of each Right should approximate the value of one
Common Share.
If any person or group of affiliated or associated persons becomes an Acquiring
Person (unless the event by which such Person became an Acquiring Person is a
Permitted Offer described in the following paragraph), then each holder of a
Right, other than Rights beneficially owned by the Acquiring Person and certain
transferees thereof (which will thereafter be void), will thereafter have the
right to receive, upon exercise thereof at the then current Purchase Price of
the Right, that number of Common Shares having a market value of two times such
Purchase Price of the Right, subject to certain possible adjustments.
If, at any time after there is an Acquiring Person, the Company is acquired in
certain mergers or other business combination transactions (other than certain
transactions with a subsidiary of the Company or a transaction with a person who
acquired Common Shares through a tender offer or exchange offer for all
outstanding Common Shares of the Company determined by the Board of Directors to
be in the best interests of the Company and its stockholders (a "Permitted
Offer") or 50% or more of the assets or earning power of the Company and its
subsidiaries (taken as a whole) are sold, each holder of a Right (other than
Rights which have become void under the terms of the Rights Agreement) will
thereafter have the right to receive, upon exercise thereof at the then current
Purchase Price of the Right, that number of Common Shares of the acquiring
company (or, in certain cases, one of its affiliates) having a market value of
two times such Purchase Price of the Right.
In certain events specified in the Rights Agreement, the Company is permitted
temporarily to suspend the exercisability of the Rights.
4
At any time after a person or group of affiliated or associated persons becomes
an Acquiring Person, and prior to the acquisition by a person or group of
affiliated or associated persons of 50% or more of the outstanding Common
Shares, the Board of Directors of the Company may exchange all or part of the
Rights (other than Rights which have become void under the terms of the Rights
Agreement) for Common Shares at an exchange ratio of one Common Share per Right,
subject to adjustment.
At any time prior to such time as any Person becomes an Acquiring Person, the
Board of Directors of the Company may redeem the Rights in whole, but not in
part, at a price of $.01 per Right, subject to adjustment, payable in cash,
Common Shares or any other form of consideration deemed appropriate by the Board
of Directors. The period of time during which the Rights may be redeemed may be
extended if no person has become an Acquiring Person. The redemption of the
Rights may be made effective at such time, on such basis and with such
conditions as the Board of Directors in its sole discretion may establish.
Until a Right is exercised, the holder thereof, as such, will have no rights as
a stockholder of the Company, including without limitation, the right to vote or
to receive dividends. In addition, the Company will have no liability to holders
of Rights or of the Common Shares for any failure to comply with the Rights
Agreement during any period the Board of Directors is unaware of the existence
of the Acquiring Person.
Takeover attempts frequently include coercive tactics to deprive the Company's
Board of Directors and its stockholders of any real opportunity to determine the
destiny of the Company. The Rights have been declared by the Board in order to
deter such tactics which do not maximize stockholder value, including a gradual
accumulation of shares in the open market of 15% or greater position to be
followed by a merger or a partial or two-tier tender offer that does not treat
all stockholders equally. These tactics unfairly pressure stockholders, squeeze
them out of their investment without giving them any real choice and deprive
them of the full value of their shares.
The Rights approved by the Board of Directors are designed to protect and
maximize the value of the outstanding equity interests in the Company in the
event of an unsolicited attempt by an acquirer to take over the Company in a
manner or on terms not approved by the Board of Directors. Subject to the
restrictions described above, the Rights may be redeemed by the Company at $0.01
per Right at any time prior to such time as any Person becomes an Acquiring
Person. Accordingly, the Rights should not interfere with any merger or business
combination approved by the Board of Directors.
However, the Rights may have the effect of rendering more difficult or
discouraging an acquisition of the Company deemed undesirable by the Board of
Directors. The Rights may cause substantial dilution to a person or group that
attempts to acquire the Company on terms or in a manner not approved by the
Company's Board of Directors, except pursuant to an offer conditioned upon the
negation, purchase or redemption of the Rights.
Issuance of the Rights does not in any way weaken the financial strength of the
Company or interfere with its business plans. The issuance of the Rights
themselves has no dilutive effect, will not affect reported earnings per share,
should not be taxable to the Company or to its stockholders, and will not change
the way in which the Company's Common Shares are presently traded.
5
Additionally, the Company's Board of Directors approved and adopted several
amendments to the Company's bylaws providing for: (a) advance notice of
stockholder proposals and stockholder nominations for the election of directors;
(b) a mandate that the board of directors determine a record date for any action
taken by a written consent of the stockholders; and (c) verification of
stockholder consents. A copy of the Company's bylaws, as amended on May 17,
2002, is filed as an exhibit to this Form 8-K and is incorporated herein by
reference.
A copy of the press release issued by the Company on May 21, 2002 announcing the
Board of Directors' adoption of the Rights Agreement and the amendments to the
bylaws described above is filed as an exhibit to this Form 8-K.
Clinical Studies of PEG-INTRON(R) and REBETOL(R) Combination Therapy for
Hepatitis C
On May 21, 2002, the Company announced that Schering-Plough Corporation
("Schering Plough") reported results of several clinical studies presented at
the 2002 Digestive Disease Week conference in San Francisco, involving
PEG-INTRON(R) (peginterferon alfa-2b) Powder for Injection in combination with
REBETOL(R) (ribavirin, USP) Capsules for the treatment of chronic hepatitis C.
In all, 33 studies with PEG-INTRON were presented by clinical investigators.
PEG-INTRON is a longer-acting form of INTRON(R) A (interferon alfa-2b,
recombinant) Injection that uses proprietary PEG technology developed by the
Company. Under the Company's licensing agreement with Schering-Plough, the
Company is entitled to royalties on worldwide sales of PEG-INTRON.
Schering-Plough holds an exclusive worldwide license to PEG-INTRON.
PEG-INTRON and REBETOL combination therapy received U.S. Food and Drug
Administration (FDA) approval in August 2001 for the treatment of chronic
hepatitis C in patients with compensated liver disease who have not been
previously treated with interferon alpha and are at least 18 years of age.
In an oral presentation, investigators reported clinical data from one of the
largest clinical trials studying African Americans with hepatitis C. The study
indicated that the commonly lower response rate to treatment among African
Americans is not related to genotype, as previously believed. Researchers have
attributed lower treatment response rates in African Americans to the fact that
this patient population predominantly contracts genotype 1 virus, which is the
most difficult to treat. In this study, which compared the treatment response
rate of African Americans to response rates of non-Hispanic whites, 98 percent
of all patients studied had genotype 1. In the African American patient group,
28% had a virologic response after 12 weeks of therapy compared to a 58%
response rate in the non-Hispanic white patient group. At week 24 of treatment,
25% of African Americans tested negative for the virus vs. 62% of non-Hispanic
whites, indicating that factors other than genotype were affecting response to
therapy.
Researchers enrolled 100 African Americans and 100 non-Hispanic whites who had
not been previously treated with alpha interferon therapy into each group. All
patients received PEG-
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INTRON (1.5 mcg/kg/week) for 48 weeks plus REBETOL (1,000 mg/day) for 12 weeks
followed by 800 mg/day for 36 weeks. Patients with decompensated liver disease
were excluded from the study.
Preliminary data from the WIN-R trial, the largest ongoing prospective study to
evaluate the safety and efficacy of weight-based dosing with PEG-INTRON and
REBETOL combination therapy, indicated that patients receiving daily REBETOL
dosages (800-1,400 mg) according to their body weight may not have any
difference in the rate of significant adverse events than patients receiving a
flat daily dose (800 mg) of REBETOL. Both groups were given REBETOL in
combination with once-weekly PEG-INTRON (1.5 mcg/kg). Although patients
receiving the weight-based dose of REBETOL experienced a moderate increase in
anemia, there was no incremental anemia in patients receiving 1,400 mg of
REBETOL daily compared to the other doses of REBETOL received in weight-based
dosing. Researchers also found no clinically important differences or platelet
decreases in neutropenia or loss of white blood cells at the higher ribavirin
doses. In addition, patients dosed according to body weight had less severe
platelet decreases and similar serious-adverse-event and discontinuation rates
than those who had been given the standard 800 mg daily REBETOL dose.
The results of the COPILOT (Colchicine versus PEG-INTRON Long-Term) study, which
investigated maintenance therapy with PEG-INTRON in patients with advanced
cirrhosis, were also presented. In this study, 250 patients with advanced
cirrhosis who had previously failed interferon-based therapy were randomized to
two groups: 130 patients received once-weekly PEG-INTRON (0.5 mcg/kg) and 120
patients received colchicine (0.6 mg twice-daily). At the end of one year of
treatment, the PEG-INTRON group had a reduction in detectable(1) virus (HCV
RNA), while the virus levels in the colchicine group remained the same. These
findings may be important for patients who have not responded to previous
therapy.
PEG-INTRON, which is approved for dosing according to patient body weight, is
the first and only pegylated interferon product approved for marketing in the
United States. PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000
dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy designed to
optimize the balance between antiviral activity and elimination half-life.
----------
(1) Defined as HCV-RNA below limit of detection using a research-based RT-PCR
assay.
7
Item 7. Exhibits
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3(ii) Bylaws, as amended on May 17, 2002
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3(iv) Certificate of Elimination, as filed with the Secretary of State of
the State of Delaware on May 22, 2002
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3(v) Certificate of Designation with respect to the Series B
Preferred Stock, par value $.01 per share, of the Company,
as filed with the Secretary of State of the
State of Delaware on May 22, 2002
--------------------------------------------------------------------------------
4.3 Rights Agreement dated as of May 17, 2002 ("Rights
Agreement") between the Company and Continental Stock Transfer &
Trust Company, as Rights Agent
--------------------------------------------------------------------------------
4.5 Form of Right Certificate (filed as Exhibit B to the Rights
Agreement). Pursuant to the Rights Agreement, printed Right
Certificates will not be mailed until the
Distribution Date (as defined in the Rights Agreement)
--------------------------------------------------------------------------------
4.6 Summary of Rights (filed as Exhibit C to the Rights Agreement)
--------------------------------------------------------------------------------
99.1 Press Release, dated May 22, 2002
--------------------------------------------------------------------------------
Except for the historical information herein, the matters discussed in
this filing include forward-looking statements that may involve a number of
risks and uncertainties. Actual results may vary significantly based upon a
number of factors, which are described in the Company's Form 10-K, Form 10-Q's
and Form 8-K's on file with the SEC, including without limitation, regulatory
risks such as risks in obtaining and maintaining regulatory approval for
indications and expanded indications, risks that Enzon will not outperform the
sector, risks related to research and development costs and capabilities, market
acceptance of and continuing demand for Enzon's products and the impact of
competitive products and pricing.
# # #
8
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Dated: May 22, 2002
/s/ Arthur J. Higgins
------------------------------------
By: Arthur J. Higgins
Title: Chairman, President and Chief
Executive Officer