UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
----------------------------
FORM 10-Q
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
---------------------------
For the Quarter Ended September 30, 2001 Commission File No. 0-12957
[LOGO] ENZON, INC.
(Exact name of registrant as specified in its charter)
Delaware 22-2372868
(State or other jurisdiction of (IRS Employer
incorporation or organization) Identification No.)
20 Kingsbridge Road, Piscataway, New Jersey 08854
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (732) 980-4500
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $.01 par value
(Title of class)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes __X__ No _____
As of November 9, 2001, there were 42,760,559 shares of Common Stock, par
value $.01 per share, outstanding.
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
ENZON, INC. AND SUBSIDIARIES
CONSOLIDATED CONDENSED BALANCE SHEETS
September 30, 2001 and June 30, 2001
(unaudited)
September 30, June 30, 2001
2001 *
------------- -------------
ASSETS
Current assets:
Cash and cash equivalents $ 362,930,192 $ 310,223,837
Short-term investments 31,269,586 129,520,083
Accounts receivable 12,415,265 11,087,748
Inventories 1,821,697 1,852,144
Other current assets 2,973,142 2,837,199
------------- -------------
Total current assets 411,409,882 455,521,011
------------- -------------
Property and equipment 14,207,631 13,181,671
Less accumulated depreciation and amortization 9,703,044 9,761,999
------------- -------------
4,504,587 3,419,672
------------- -------------
Other assets:
Investments 128,007,388 76,675,557
Debt issue costs, net 12,317,808 12,774,951
Patents and other assets, net 1,186,401 1,284,626
------------- -------------
141,511,597 90,735,134
------------- -------------
Total assets $ 557,426,066 $ 549,675,817
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 3,605,769 $ 4,670,259
Accrued expenses 3,984,778 4,740,081
Accrued interest 4,786,986 --
------------- -------------
Total current liabilities 12,377,533 9,410,340
------------- -------------
Accrued rent 574,819 581,438
Royalty advance-Aventis 694,814 694,814
Notes payable 400,000,000 400,000,000
------------- -------------
401,269,633 401,276,252
------------- -------------
Stockholders' equity:
Preferred stock-$.01 par value, authorized 3,000,000 shares;
issued and outstanding 7,000 shares at September 30,
2001 and June 30, 2001 (liquidation preference
aggregating $336,000 at September 30, 2001 and
$333,000 at June 30, 2001) 70 70
Common stock-$.01 par value, authorized 60,000,000 shares;
issued and outstanding 42,218,159 shares at September
30, 2001 and 41,990,859 shares at June 30, 2001 422,182 419,909
Additional paid-in capital 258,984,251 257,682,479
Accumulated other comprehensive income 63,608 884,935
Deferred compensation (1,432,433) (1,509,171)
Accumulated deficit (114,258,778) (118,488,997)
------------- -------------
Total stockholders' equity 143,778,900 138,989,225
------------- -------------
Total liabilities and stockholders' equity $ 557,426,066 $ 549,675,817
============= =============
* Condensed from audited financial statements.
The accompanying notes are an integral part of these unaudited consolidated
condensed financial statements.
2
ENZON, INC. AND SUBSIDIARIES
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
Three Months Ended September 30, 2001 and 2000
(Unaudited)
Three months ended
September 30, September 30,
2001 2000
------------ ------------
Revenues:
Net Sales $ 5,106,490 $ 4,615,102
Royalties 6,987,313 332,166
Contract revenue 49,899 226,346
------------ ------------
Total revenues 12,143,702 5,173,614
------------ ------------
Costs and expenses:
Cost of sales 1,390,861 1,001,188
Research and development expenses 3,497,157 2,636,597
Selling, general and administrative expenses 4,122,111 3,074,227
------------ ------------
Total costs and expenses: 9,010,129 6,712,012
------------ ------------
Operating Income (loss) 3,133,573 (1,538,398)
------------ ------------
Other income (expense):
Interest and dividend income 6,178,299 2,109,213
Interest expense (4,994,129) --
Other (1,192) 11,891
------------ ------------
1,182,978 2,121,104
------------ ------------
Income before taxes 4,316,551 582,706
Tax provision 86,331 --
------------ ------------
Net income $ 4,230,220 $ 582,706
============ ============
Basic earnings per common share $ 0.10 $ 0.01
============ ============
Diluted earnings per common share $ 0.10 $ 0.01
============ ============
Weighted average number of common shares
outstanding - basic 42,122,284 41,101,289
============ ============
Weighted average number of common shares and dilutive
potential common shares outstanding 43,922,829 43,658,659
============ ============
The accompanying notes are an integral part of these unaudited consolidated
condensed financial statements.
3
ENZON, INC. AND SUBSIDIARIES
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
Three Months Ended September 30, 2001 and 2000
(Unaudited)
Three Months Ended
September 30, September 30,
2001 2000
------------- -------------
Cash flows from operating activities:
Net income $ 4,230,220 $ 582,706
Adjustment for depreciation and amortization 659,959 130,659
Non-cash expense for issuance of common stock,
Stock options 76,738 --
Loss on retirement of assets 3,798 --
Amortization of bond premium/discount (3,345,705) (100,524)
Decrease in accrued rent (6,619) (6,619)
Changes in assets and liabilities 1,900,118 41,985
------------- -------------
Net cash provided by operating activities 3,518,509 648,207
------------- -------------
Cash flows from investing activities:
Capital expenditures (1,256,041) (127,234)
Proceeds from sale of investments 170,938,000 19,600
Maturities of investments 87,060,000 5,500,000
Purchase of Investments (208,554,956) (19,050,859)
Decrease in investments -- 5,950,859
------------- -------------
Net cash (used in) provided by investing activities 48,187,003 (7,707,634)
------------- -------------
Cash flows from financing activities:
Proceeds from issuance of common stock 1,000,843 2,379,407
------------- -------------
Net increase (decrease) in cash and cash equivalents 52,706,355 (4,680,020)
Cash and cash equivalents at beginning of period 310,223,837 31,935,410
------------- -------------
Cash and cash equivalents at end of period $ 362,930,192 $ 27,255,390
============= =============
The accompanying notes are an integral part of these unaudited consolidated
condensed financial statements.
4
ENZON, INC. AND SUBSIDIARIES
Notes To Consolidated Condensed Financial Statements
(Unaudited)
(1) Organization and Basis of Presentation
The unaudited consolidated condensed financial statements have been
prepared from the books and records of Enzon, Inc. and its subsidiaries in
accordance with generally accepted accounting principles for interim financial
information. Accordingly, they do not include all of the information and
footnotes required by generally accepted accounting principles for complete
financial statements. In the opinion of management, all adjustments (consisting
only of normal and recurring adjustments) considered necessary for a fair
presentation have been included. Interim results are not necessarily indicative
of the results that may be expected for the year.
(2) Comprehensive Income
The following table reconciles net income to comprehensive income:
Three months ended
September 30,
2001 2000
----------- -----------
Net income $ 4,230,000 $ 583,000
Other comprehensive income (loss):
Unrealized holding gain arising
during the period 64,000 --
Less: reclassification adjustment for
net gain realized in net income 885,000 --
----------- -----------
Total other comprehensive income (loss) (821,000) --
----------- -----------
Total comprehensive income $ 3,409,000 $ 583,000
=========== ===========
(3) Earnings (loss) Per Common Share
Basic earnings per share is computed by dividing the net income available
to common shareholders adjusted for cumulative undeclared preferred stock
dividends for the relevant period, by the weighted average number of shares of
Common Stock issued and outstanding during the periods. For purposes of
calculating diluted earnings per share for the quarters ended September 30, 2001
and 2000, the denominator includes both the weighted average number of shares of
Common Stock outstanding and the number of dilutive Common Stock equivalents.
The number of dilutive Common Stock equivalents includes the effect of
non-qualified stock options calculated using the treasury stock method, the
number of shares issuable upon conversion of the outstanding Series A Preferred
Stock and the unvested shares of restricted stock which have been issued. The
number of shares issuable upon conversion of the Company's 4.5% Convertible
Subordinated Notes due 2008 (the "Notes") have not been included as the effect
of their inclusion would be antidilutive. As of September 30, 2001, the Company
had 9,640,000 dilutive potential common shares outstanding that could
potentially dilute future earnings per share calculations.
5
ENZON, INC. AND SUBSIDIARIES
Notes To Consolidated Condensed Financial Statements
(Unaudited)
The following table reconciles the basic and diluted earnings per share
calculation:
Three months ended
September 30, 2001
2001 2000
----------- -----------
Net income $ 4,230,000 $ 583,000
Less: preferred stock dividends 4,000 4,000
----------- -----------
Net income available to
common stockholders $ 4,226,000 $ 579,000
----------- -----------
Weighted average number of
common shares issued and
outstanding - basic 42,122,284 41,101,289
Effect of dilutive common stock
equivalents:
Conversion of preferred stock 16,000 16,000
Exercise of non-qualified
stock options 1,759,545 2,541,370
Unvested restricted stock award 25,000 --
----------- -----------
43,922,829 43,658,659
=========== ===========
(4) Inventories
The composition of inventories at September 30, 2001 and June 30, 2001 is
as follows:
September 30, June 30,
2001 2001
---------- ----------
Raw materials $ 425,000 $ 421,000
Work in process 637,000 737,000
Finished goods 760,000 694,000
---------- ----------
$1,822,000 1,852,000
========== ==========
(5) Cash Flow Information
The Company considers all highly liquid securities with original maturities
of three months or less to be cash equivalents. There were no cash payments made
for interest for the three months ended September 30, 2001 or 2000. There were
no income tax payments made for the three months ended September 30, 2001 and
2000.
(6) Income taxes
The Company expects to be profitable for the year ending June 30, 2002, and
accordingly has recognized a tax provision for the three months ended September
30, 2001. The tax provision represents the Company's anticipated Alternative
Minimum Tax liability based on anticipated fiscal 2002 taxable income.
6
ENZON, INC. AND SUBSIDIARIES
Notes To Consolidated Condensed Financial Statements
(Unaudited)
(7) Business Segments
A single management team that reports to the Chief Executive Officer
comprehensively manages the Company's business operations. The Company does not
operate separate lines of business or separate business entities with respect to
any of its approved products or product candidates. In addition, the Company
does not conduct any operations outside of the United States. The Company does
not prepare discrete financial statements with respect to separate product
areas. Accordingly, the Company does not have separately reportable segments as
defined by Statement of Financial Accounting Standards No. 131, "Disclosures
about Segments of an Enterprise and Related Information."
(8) Schering-Plough Agreement
In August 2001, the Company's development partner for PEG-INTRON,
Schering-Plough Corporation, received approval from the United States Food and
Drug Administration (FDA) for PEG-INTRON for use in combination therapy with
REBETOL(R) capsules for the treatment of chronic hepatitis C. In October 2001,
Schering-Plough announced the U.S. launch of PEG-INTRON and REBETOL combination
therapy for the treatment of chronic hepatitis C. Under its licensing agreement
with Schering-Plough, Enzon is entitled to royalties on worldwide sales of
PEG-INTRON. The royalties received on these sales are recognized when earned.
7
Item 2. Management's Discussion and Analysis of Financial Condition and Results
of Operations
Information contained herein 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. We cannot assure you that the future results covered by the
forward-looking statements will be achieved. The matters set forth in the "Risk
Factors" section and elsewhere in our Annual Report on Form 10-K for the fiscal
year ended June 30, 2001, which is incorporated herein by reference, 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.
Results of Operations
Three months ended September 30, 2001 vs. Three months ended September 30, 2000
Revenues. Revenues for the three months ended September 30, 2001 increased
by 135% to $12,144,000, as compared to $5,174,000 for the same period in the
prior year. The components of revenues are sales of our products, royalties we
earn on the sales of our products by others, and contract revenues. Sales
increased by 11% to $5,107,000 for the three months ended September 30, 2001, as
compared to $4,615,000 for the same period in the prior year. The increase was
primarily due to increased ONCASPAR sales. The increase in ONCASPAR sales was
due to the lifting of all of the distribution restrictions imposed by the FDA
that were in place during the prior year. These distribution restrictions were
related to a previously disclosed manufacturing problem and resulted in prior
year sales being lower than in the current quarter. During October 2000, the FDA
gave final approval to manufacturing changes which we had proposed to correct
these manufacturing problems and removed all previously imposed distribution and
labeling restrictions. This will allow for the resumption of normal distribution
and labeling of this product by our marketing partner, Aventis Pharmaceuticals,
which is expected to take place in the first half of calendar year 2002. We
expect lower revenues from ONCASPAR in future quarters when Aventis resumes
distribution of the product and our revenue stream reverts back to a 27.5%
royalty rate on net sales. ADAGEN sales decreased by 12% over the prior year due
to the timing of shipments of the product. Sales of ADAGEN for the three months
ended September 30, 2001 and 2000 were $2,923,000 and $3,319,000, respectively.
Royalties for the quarter ended September 30, 2001, increased to $6,987,000
as compared to $332,000 in the prior year. The increase was primarily due to the
commencement of sales of PEG-INTRON in the U.S. and increased sales in Europe.
Schering-Plough, our marketing partner of PEG-INTRON, began selling PEG-INTRON
in the European Union in June 2000 and in the U.S. in February 2001. PEG-INTRON
also received marketing approval for use in combination with REBETOL for the
treatment of hepatitis C in the European Union in March 2001 and in the U.S. in
August 2001. PEG-INTRON in combination with REBETOL was launched in the U.S. by
Schering-Plough in October 2001.
Contract revenue for the quarter ended September 30, 2001 decreased by 78%
to $50,000 as compared to $226,000 in the same period in the prior year. This
decrease was related primarily to a $200,000 payment from one of our development
partners which was earned in the quarter ended September 30, 2000. No such
payment was received in the current quarter.
During the three months ended September 30, 2001, we had export sales and
royalties on export sales of $4,916,000, of which $4,622,000 were in Europe.
Export sales and royalties recognized on export sales for the prior year were
$1,622,000, of which $1,464,000 were in Europe.
8
Cost of Sales. Cost of sales, as a percentage of sales, increased to 27%
for the three months ended September 30, 2001 as compared to 22% for the same
period in 2000. This increase was due to lower cost of goods sold during the
prior year's quarter due to the reversal of a contingency reserve for ONCASPAR
finished goods due to the previously disclosed manufacturing problems.
Research and Development. Research and development expenses for the three
months ended September 30, 2001 increased by 33% to $3,497,000 as compared to
$2,637,000 for the same period in 2000. The increase was due to increased
contracted services related to clinical trials and pre-clinical studies for
products under development, including PROTHECAN (PEG-camptothecin) and
PEG-paclitaxel. Research and development activities are expected to continue to
increase significantly as we continue the advancement of the current and
additional Phase II clinical trials for PROTHECAN, we continue our Phase I
clinical trials for PEG-paclitaxel, and we conduct pre-clinical and clinical
trials for additional compounds.
Selling, General and Administrative Expenses. Selling, general and
administrative expenses for the three months ended September 30, 2001, increased
by 34% to $4,122,000, as compared to $3,074,000 for the same period in 2000. The
increase was primarily due to costs related to the identification and review of
potential strategic acquisitions of technologies, products and companies.
Other Income/Expense. Other income/expense decreased to $1,183,000 as
compared to $2,121,000 for the prior year. The decrease was attributable to an
increase in interest expense due to the issuance of $400,000,000 of convertible
subordinated notes during June 2001 as well as a decrease in interest rates on
interest bearing investments. The notes bear interest at an annual rate of 4.5%.
Provision for Taxes. The Company expects to be profitable for the year
ending June 30, 2002, and accordingly has recognized a tax provision for the
three months ended September 30, 2001. The tax provision represents the
Company's anticipated Alternative Minimum Tax liability based on anticipated
fiscal 2002 taxable income.
Liquidity and Capital Resources
Total cash reserves, which include cash, cash equivalents and marketable
securities, were $522,158,000 as of September 30, 2001, as compared to
$516,379,000 as of June 30, 2001. We invest our excess cash primarily in United
States government-backed securities. The increase in total cash reserves was due
to cash provided by operations.
As of September 30, 2001, the Company had $400,000,000 of 4.5% convertible
subordinated notes outstanding. The notes bear interest at an annual rate of
4.5%. Interest is payable on January 1 and July 1 of each year beginning January
1, 2002. Accrued interest on the notes was approximately $4,787,000 as of
September 30, 2001. The holders may convert all or a portion of the notes into
common stock at any time on or before July 1, 2008. The notes are convertible
into our common stock at a conversion price of $70.98 per share, subject to
adjustment in certain events. The notes are subordinated to all existing and
future senior indebtedness. On or after July 7, 2004, we may redeem any or all
of the notes at specified redemption prices, plus accrued and unpaid interest to
the day preceding the redemption date. The notes will mature on July 1, 2008
unless earlier converted, redeemed at our option or redeemed at the option of
the noteholder upon a fundamental change, as described in the indenture for the
notes. Neither we nor any of our subsidiaries are subject to any financial
covenants under the indenture. In addition, neither we nor any of our
subsidiaries are restricted under the indenture from paying dividends, incurring
debt, or issuing or repurchasing our securities.
To date, our sources of cash have been the proceeds from the sale of our
stock through public offerings and private placements, the issuance of the 4.5%
convertible subordinated notes, sales of and royalties on sales of ADAGEN,
ONCASPAR, and PEG-INTRON, sales of our products for research
9
purposes, contract research and development fees, technology transfer and
license fees and royalty advances.
Under our amended license agreement with Aventis, we received a payment of
$3,500,000 in advance royalties in January 1995. Royalties due under the amended
license agreement will be offset against an original credit of $5,970,000, which
represents the royalty advance plus reimbursement of certain amounts due Aventis
under the original agreement and interest expense, before cash payments will be
made under the agreement. The royalty advance is shown as a long-term liability.
The corresponding current portion of the advance is included in accrued expense
on the consolidated balance sheets. We will reduce the advance as royalties are
recognized under the agreement. Through September 30, 2001, an aggregate of
$4,307,000 in royalties payable by Aventis has been offset against the original
credit.
As of September 30, 2001, 1,043,000 shares of Series A preferred stock had
been converted into 3,325,000 shares of common stock. Accrued dividends on the
converted Series A preferred stock in the aggregate of $3,770,000 were settled
by the issuance of 235,000 shares of common stock and cash payments of
$1,947,000. The shares of Series A preferred stock outstanding at September 30,
2001 are convertible into approximately 16,000 shares of common stock. Dividends
accrue on the remaining outstanding shares of Series A preferred stock at a rate
of $14,000 per year. As of September 30, 2001, there were accrued and unpaid
dividends totaling $161,000 on the 7,000 shares of Series A preferred stock
outstanding. We have the option to pay these dividends in either cash or common
stock.
Our current sources of liquidity are cash, cash equivalents and interest
earned on such cash reserves, sales of and royalties on sales of ADAGEN,
ONCASPAR, and PEG-INTRON, and license fees. Based upon our currently planned
research and development activities and related costs and our current sources of
liquidity, we anticipate our current cash reserves will be sufficient to meet
our capital, debt service and operational requirements for the foreseeable
future.
We may seek additional financing, such as through future offerings of
equity or debt securities or agreements with collaborators with respect to the
development and commercialization of products, to fund future operations and
potential acquisitions. We cannot assure you, however, that we will be able to
obtain additional funds on acceptable terms, if at all.
Recently Issued Accounting Standards
In July 2001, the FASB issued SFAS No. 141, Business Combination, and SFAS
No. 142, Goodwill and Other Intangible Assets. SFAS 141 requires that all
business combinations be accounted for under a single method - the purchase
method. Use of the pooling-of-interests method no longer is permitted. SFAS 141
requires that the purchase method be used for business combinations initiated
after June 30, 2001. SFAS 142 requires that goodwill no longer be amortized to
earnings, but instead be reviewed for impairment. SFAS 142 has no impact on our
historical financial statements as we do not have any goodwill or intangible
assets, which resulted from business combinations.
In August 2001, the FASB issued SFAS No. 143, Accounting for Asset
Retirement Obligations, which addresses financial accounting and reporting for
obligations associated with the retirement of tangible long-lived assets and the
associated asset retirement costs. SFAS 143 requires an enterprise to record the
fair value of an asset retirement obligation as a liability in the period in
which it incurs a legal obligation associated with the retirement of tangible
long-lived assets. Since the requirement is to recognize the obligation when
incurred, approaches that have been used in the past to accrue the asset
retirement obligation over the life of the asset are no longer acceptable. SFAS
143 also requires the enterprise to record the contra to the initial obligation
as an increase to the carrying amount of the related long-lived asset (i.e., the
associated asset retirement costs) and to depreciate that cost over the life of
the asset. The liability is increased at the end of each period to reflect the
passage of time (i.e., accretion expense) and changes in the estimated future
cash flows underlying the initial fair value measurement. Enterprises are
10
required to adopt Statement 143 for fiscal years beginning after June 15, 2002.
We are in the process of evaluating this SFAS and the effect that it will have
on our consolidated financial statements and current impairment policy.
Item 3a. Quantitative and Qualitative Disclosures About Market Risk
The following discussion about our exposure to market risk of financial
instruments contains forward-looking statements. Actual results may differ
materially from those described.
Our holdings of financial instruments are comprised of debt securities and
time deposits. All such instruments are classified as securities
available-for-sale. We do not invest in portfolio equity securities or
commodities or use financial derivatives for trading purposes. Our debt security
portfolio represents funds held temporarily pending use in our business and
operations. We manage these funds accordingly. We seek reasonable assuredness of
the safety of principal and market liquidity by investing in rated fixed income
securities while at the same time seeking to achieve a favorable rate of return.
Our market risk exposure consists principally of exposure to changes in interest
rates. Our holdings are also exposed to the risks of changes in the credit
quality of issuers. We typically invest the majority of our investments in the
shorter-end of the maturity spectrum, and at September 30, 2001 all of our
holdings were in instruments maturing in 4 years or less.
The table below presents the principal amounts and related weighted average
interest rates by year of maturity for our investment portfolio as of September
30, 2001.
2002 2003 2004 2005 Total Fair Value
---------- ---------- ---------- ---------- ----------- -----------
Fixed Rate 31,206,000 11,751,000 94,279,000 21,936,000 159,172,000 159,236,000
Average Interest Rate 5.63% 3.31% 3.98% 3.96% 4.25% --
Variable Rate -- -- -- -- -- --
Average Interest Rate -- -- -- -- -- --
---------- ---------- ---------- ---------- ----------- -----------
31,206,000 11,751,000 94,279,000 21,936,000 159,172,000 159,236,000
========== ========== ========== ========== =========== ===========
Our 4.5% convertible subordinated notes in the principal amount of
$400,000,000 due July 1, 2008 have fixed interest rates. The fair value of fixed
interest rate convertible notes is affected by changes in interest rates and by
changes in the price of our common stock.
11
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits (numbered in accordance with Item 601 of Regulation S-K).
Page Number
or
Exhibit Incorporation
Number Description By Reference
- ------ ----------- ------------
3(i) Certificate of Incorporation as amended ~~
3(ii) By laws, as amended *(4.2)
3(iv) Amendment to Certificate of Incorporation dated January 5, 1998 ##3(iv)
4.1 Indenture dated as of June 26, 2001, between the Company and
Wilmington Trust Company, as trustee, including the form of 4 1/2%
Convertible Subordinated Note due 2008 attached as Exhibit A thereto ++++(4.1)
4.2 Registration Rights Agreement dated as of June 26, 2001, between the
Company and the initial purchasers ++++(4.2)
10.1 Form of Change of Control Agreements dated as of January 20, 1995
entered into with the Company's Executive Officers ###(10.2)
10.2 Lease - 300-C Corporate Court, South Plainfield, New Jersey ***(10.3)
10.3 Lease dated April 1, 1995 regarding 20 Kingsbridge
Road, Piscataway, New Jersey ###(10.7)
10.4 Lease 300A-B Corporate Court, South Plainfield, New Jersey ++(10.10)
10.5 Form of Stock Purchase Agreement between the Company
and the purchasers of the Series A Cumulative
Convertible Preferred Stock +(10.11)
10.6 Employment Agreement with Peter G. Tombros dated as of
August 10, 2000 //(10.15)
10.7 Stock Purchase Agreement dated as of June 30, 1995 ~(10.16)
10.8 Independent Directors' Stock Plan ~~~(10.24)
10.9 Underwriting Agreement dated March 20, 2000 with Morgan
Stanley & Co. Inc., CIBC World Markets Corp., and SG
Cowen Securities Corporation /(10.29)
10.10 Employment Agreement dated May 9, 2001, between the Company
and Arthur J. Higgins ///(10.30)
10.11 Amendment dated May 23, 2001, to Employment Agreement between
the Company and Arthur J. Higgins dated May 9, 2001 ///(10.31)
10.12 Form of Restricted Stock Award Agreement between the Company and
Arthur J. Higgins ////(4.3)
10.13 Form of Employee Retention Agreement dated as of August 3, 2001
between the Company and certain key employees +++
* Previously filed as an exhibit to the Company's Registration Statement on
Form S-2 (File No. 33-34874) and incorporated herein by reference thereto.
*** Previously filed as an exhibit to the Company's Registration Statement on
Form S-18 (File No. 2-88240-NY) and incorporated herein by reference
thereto.
+ Previously filed as an exhibit to the Company's Registration Statement on
Form S-1 (File No. 33-39391) filed with the Commission and incorporated
herein by reference thereto.
++ Previously filed as an exhibit to the Company's Annual Report on Form 10-K
for the fiscal year ended June 30, 1993 and incorporated herein by
reference thereto.
12
+++ Previously filed as an exhibit to the Company's Annual Report on Form 10-K
for the fiscal year ended June 30, 2001 and incorporated herein by
reference thereto.
++++ Previously filed as an exhibit to the Company's Registration Statement on
Form S-3 (File No. 333-67509) filed with the Commission and incorporated
herein by reference thereto.
## Previously filed as an exhibit to the Company's Quarterly Report on Form
10-Q for the quarter ended December 31, 1997 and incorporated herein by
reference thereto.
### Previously filed as an exhibit to the Company's Quarterly Report on Form
10-Q for the quarter ended March 31, 1995 and incorporated herein by
reference thereto.
~ Previously filed as an exhibit to the Company's Quarterly Report on Form
10-Q for the quarter ended December 31, 1995 and incorporated herein by
reference thereto.
~~ Previously filed as an exhibit to the Company's Quarterly Report on Form
10-Q for the quarter ended March 31, 1996 and incorporated herein by
reference thereto.
~~~ Previously filed as an exhibit to the Company's Quarterly Report on Form
10-Q for the quarter ended December 31, 1996 and incorporated herein by
reference thereto.
/ Previously filed as an exhibit to the Company's Registration Statement on
Form S-3 (File No. 333-30818) filed with the Commission and incorporated
herein by reference thereto.
// Previously filed as an exhibit to the Company's Annual Report on Form 10-K
for the year ended June 30, 2000 and incorporated herein by reference
thereto.
/// Previously filed as an exhibit to the Company's Current Report on Form 8-K
filed with the Commission on June 13, 2001 and incorporated herein by
reference thereto.
//// Previously filed as an exhibit to the Company's Registration Statement on
Form S-8 (File No. 333-64110) filed with the Commission and incorporated
herein by reference thereto.
13
(b) Reports on Form 8-K.
On July 17, 2001, we filed with the Commission a Current Report on Form 8-K
dated July 3, 2001 reporting that Schering-Plough submitted a supplemental
Biologics License Application to the FDA seeking marketing approval for
PEG-INTRON(TM) (peginterferon alfa-2b) Redipen(TM) Single-dose Delivery System.
In addition, we reported that Schering-Plough had reported that the FDA had
issued inspection reports (Form FDA-483s) which cited some continuing and some
additional deficiencies concerning compliance with current Good Manufacturing
Practices, which related to the manufacture of ribavirin, which is manufactured
at Schering-Plough's facilities.
On July 27, 2001, we filed with the Commission a Current Report on Form 8-K
dated July 24, 2001 reporting the initiation of patient dosing in a Phase II
clinical trial for PROTHECAN(R) (PEG-camptothecin) designed to evaluate the
anti-tumor activity of PROTHECAN. In addition, we reported that Schering-Plough
had been granted marketing approval from the FDA for REBETOL (ribavirin, USP)
Capsules as a separately marketed product for use only in combination with
INTRON(R) A (interferon alfa-2b, recombinant) Injection for the treatment of
chronic hepatitis C in patients with compensated liver disease previously
untreated with alpha interferon or who have relapsed following alpha interferon
therapy.
On August 9, 2001, we filed with the Commission a Current Report on Form
8-K dated August 8, 2001 reporting that Schering-Plough received approval from
the FDA for PEG-INTRON(TM) (peginterferon alfa-2b) Powder for Injection for use
in combination therapy with REBETOL(R) (ribavirin, USP) Capsules 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.
On August 13, 2001, we filed with the Commission a Current Report on Form
8-K dated August 13, 2001 reporting that Schering-Plough entered into a license
agreement with F.Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. that settles
all patent disputes relative to the two companies' respective peginterferon
products and provides for each company to manufacture and market worldwide its
peginterferon products free from liability for infringement under the other's
existing patent rights.
On August 21, 2001, we filed with the Commission a Current Report on Form
8-K dated August 21, 2001 reporting our financial results for the fourth quarter
of fiscal year 2001.
14
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 thereunto duly authorized.
ENZON, INC.
(Registrant)
Date: November 13, 2001 By: /s/Arthur J. Higgins
----------------------------------
Arthur J. Higgins
President and Chief Executive
Officer
By: /s/Kenneth J. Zuerblis
----------------------------------
Kenneth J. Zuerblis
Vice President, Finance,
Chief Financial Officer
(Principal Financial
and Accounting Officer) and
Corporate Secretary
15