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 Quarter Ended September 30, 1997 Commission File No. 0-12957
[GRAPHIC OMITTED]
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)
(732) 980-4500
(Registrant's telephone number, including area code:)
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 _____
The number of shares of common stock, $.01 par value, outstanding as of November
6, 1997 was 30,952,301 shares.
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
ENZON, INC AND SUBSIDIARIES
CONSOLIDATED CONDENSED BALANCE SHEETS
September 30, 1997 and June 30, 1997
September 30, June 30,
1997 1997
------------- -------------
(unaudited) *
ASSETS
Current assets:
Cash and cash equivalents $ 9,603,543 $ 8,315,752
Accounts receivable 2,236,513 2,433,762
Inventories 1,009,276 859,873
Other current assets 71,013 87,732
------------- -------------
Total current assets 12,920,345 11,697,119
------------- -------------
Property and equipment 15,686,182 15,676,525
Less accumulated depreciation and amortization 13,185,086 12,923,802
------------- -------------
2,501,096 2,752,723
------------- -------------
Other assets:
Investments 74,416 78,293
Other assets, net 34,830 34,575
Patents, net 1,403,949 1,442,568
------------- -------------
1,513,195 1,555,436
------------- -------------
Total assets $ 16,934,636 $ 16,005,278
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,919,049 $ 1,910,737
Accrued expenses 3,713,829 3,504,966
------------- -------------
Total current liabilities 5,632,878 5,415,703
------------- -------------
Accrued rent 838,353 870,012
Royalty advance - RPR 876,579 1,177,682
------------- -------------
1,714,932 2,047,694
------------- -------------
Commitments and contingencies
Preferred stock-$.01 par value, authorized 3,000,000 shares:
issued and outstanding 108,000 shares at September 30,
1997 and 109,000 shares at June 30, 1997 (liquidation
preference aggregating $2,700,000 at September 30, 1997 and
$2,725,000 at June 30, 1997) 1,080 1,090
Common stock-$.01 par value, authorized 40,000,000 shares;
issued and outstanding 30,913,424 shares at September
30, 1997 and 30,797,735 shares at June 30, 1997 309,134 307,977
Additional paid-in capital 121,786,973 121,426,159
Accumulated deficit (112,510,361) (113,193,345)
------------- -------------
Total stockholders' equity 9,586,826 8,541,881
------------- -------------
Total liabilities and stockholders' equity $ 16,934,636 $ 16,005,278
============= =============
*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, 1997 and 1996
(Unaudited)
Three months ended
September 30, September 30,
1997 1996
------------ ------------
Revenues
Sales $2,464,634 $2,720,591
Contract revenue 2,205,109 1,094,299
------------ ------------
Total revenues 4,669,743 3,814,890
------------ ------------
Costs and expenses
Cost of sales 604,708 985,989
Research and development expenses 2,146,969 2,429,771
Selling, general and administrative expenses 1,328,442 1,276,067
------------ ------------
Total costs and expenses 4,080,119 4,691,827
------------ ------------
Operating income (loss) 589,624 (876,937)
------------ ------------
Other income (expense)
Interest and dividend income 114,800 157,141
Interest expense (6,438) (6,753)
Other (62) 7,935
------------ ------------
108,300 158,323
------------ ------------
Net income (loss) $697,924 ($718,614)
============ ============
Net earnings (loss) per common share $0.02 ($0.03)
============ ============
Weighed average number of common
shares outstanding during the period 30,853,966 27,705,913
============ ============
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, 1997 and 1996
(Unaudited)
Three Months Ended
September 30, September 30,
1997 1996
------------ ------------
Cash flows from operating activities:
Net income (loss) $ 697,924 ($ 718,614)
Adjustment for depreciation and amortization 337,766 457,131
Loss on retirement of equipment 62 --
Non-cash expense for issuance of common stock and
stock options 119,174 48,248
Decrease in accrued rent (31,659) (23,788)
Decrease in royalty advance - RPR (257,655) (162,911)
Changes in assets and liabilities 242,559 39,354
------------ ------------
Net cash provided by (used in) operating activities 1,108,171 (360,580)
------------ ------------
Cash flows from investing activities:
Capital expenditures (47,732) (59,785)
Proceeds from sale of equipment 150 --
------------ ------------
Net cash used in investing activities (47,582) (59,785)
------------ ------------
Cash flows from financing activities:
Proceeds from issuance of common stock 227,847 2,610
Principal payments of obligations under capital leases (645) (561)
------------ ------------
Net cash provided by financing activities 227,202 2,049
------------ ------------
Net increase (decrease) in cash and cash equivalents 1,287,791 (418,316)
Cash and cash equivalents at beginning of period 8,315,752 12,666,050
------------ ------------
Cash and cash equivalents at end of period $ 9,603,543 $ 12,247,734
============ ============
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 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. Certain prior year balances were reclassified
to conform to the 1997 presentation. Interim results are not necessarily
indicative of the results that may be expected for the year, as such, the
Company has not recorded a tax provision as it does not anticipate net income to
be recognized for the year ending June 30, 1998.
(2) Net Earnings (Loss) Per Common Share
Net earnings (loss) per common share is based on the net income (loss) for
the relevant period, adjusted for the cumulative undeclared preferred stock
dividends of $54,000 and $55,000 for the three months ended September 30, 1997
and 1996, respectively, divided by the weighted average number of shares issued
and outstanding during the period. Stock options, warrants and common stock
issuable upon conversion of the preferred stock ("Common Stock Equivalents") are
not reflected as the conversion or exercise, in the aggregate, would not
materially reduce earnings per share for the three months ended September 30,
1997, for both primary and fully diluted earnings per share computations. Common
Stock Equivalents have not been reflected for the three months ended September
30, 1996, as the conversion or exercise, in the aggregate, would be antidilutive
for both primary and fully diluted earnings per share computations.
(3) Inventories
The composition of inventories at September 30, 1997 and June 30, 1997 is
as follows:
September 30, June 30,
1997 1997
------------ --------
Raw materials $ 225,000 $269,000
Work in process 395,000 269,000
Finished goods 389,000 322,000
---------- --------
$1,009,000 $860,000
========== ========
(4) Cash Flow Information
The Company considers all highly liquid securities with original maturities
of three months or less to be cash equivalents. Cash payments for interest were
approximately $6,000 and $7,000 for the three months ended September 30, 1997
and 1996, respectively. There were no income tax payments made for the three
months ended September 30, 1997 and 1996. During the three months ended
September 30, 1997, 1,000 shares of Series A Cumulative Convertible Preferred
Stock ("Series A Preferred Stock") were converted to 2,272 shares of Common
Stock. Accrued dividends of $15,000, on the Series A Preferred Stock that was
converted during the three months ended September 30, 1997, were settled by
issuing 1,358 shares of Common Stock and cash payments totaling $10 for
fractional shares. There were no conversions of Series A Preferred Stock during
the three months ended September 30, 1996. These transactions are non-cash
financing activities.
5
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. No assurance can be given that the future results covered by the
forward-looking statements will be achieved. The matters set forth in Exhibit
99.0 to the Company's Annual Report on Form 10-K for the fiscal year ended June
30, 1997, 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, 1997 vs. Three months ended September 30, 1996
Revenues. Revenues for the three months ended September 30, 1997 increased by
22% to $4,670,000 as compared to $3,815,000 for the same period in 1996. The
components of revenues are sales, which consist of sales of the Company's two
Food and Drug Administration ("FDA") approved products and royalties on the
sales of the Company's products by others, and contract revenues. Sales
decreased by 9% to $2,465,000 for the three months ended September 30, 1997, as
compared to $2,721,000 for the same period in the prior year. The decrease was
due to the timing of ONCASPAR shipments to the Company's marketing partner,
Rhone-Poulenc Rorer Pharmaceuticals, Inc. ("RPR"), which was offset in part by
increased royalties on RPR sales of ONCASPAR. Sales of ADAGEN(R) for the three
months ended September 30, 1997 and 1996 were $2,193,000 and $2,126,000,
respectively. The Company expects sales of ADAGEN to continue to be limited due
to the small patient population worldwide. The Company anticipates moderate
growth of ONCASPAR sales and increased royalties on sales of ONCASPAR. The
Company's marketing partners for ONCASPAR, RPR and MEDAC GmbH, will conduct
clinical trials to expand the use of ONCASPAR beyond its current approved
indications in the United States and Germany, which could also result in
additional revenues from this product. Such clinical trials are in progress in
the United States. There can be no assurance that any particular sales levels of
ONCASPAR or ADAGEN will be achieved or maintained. Contract revenue for the
three months ended September 30, 1997 increased by $1,111,000 to $2,205,000, as
compared to $1,094,000 for the same period in 1996. The change was principally
due to an increase in milestone payments received under the Company's licensing
agreement with Schering-Plough Corporation ("Schering-Plough"). During the
quarter ended September 30, 1997, the Company received $2,500,000 in milestone
payments from Schering-Plough related to the advancement of PEG-Intron A into a
Phase III clinical trial. During the prior year, the Company received a
$1,000,000 milestone payment under the licensing agreement with Schering-Plough.
During the three months ended September 30, 1997 and 1996, the Company had
export sales of $486,000 and $582,000, respectively. Sales in Europe were
$359,000 and $512,000 for the quarters ended September 30, 1997 and September
30, 1996, respectively.
Cost of Sales. Cost of sales, as a percentage of sales, decreased to 25% for the
three months ended September 30, 1997 as compared to 36% for the same period in
1996. The decrease was due primarily to the prior year's write-off of
approximately $200,000 in excess ONCASPAR raw material. While it is possible
that the Company may incur similar losses on its remaining purchase commitments
under the Company's supply agreement for this material, the Company does not
consider such losses probable, nor can the amount of any loss which may be
incurred in the future presently be estimated due to a number of factors,
including, but not limited to, potential increased demand for ONCASPAR from RPR,
expansion into additional markets outside the U.S. and the possibility that the
Company could renegotiate the level of required purchases. During the quarter
ended September 30, 1997, the Company utilized approximately 19% of its
manufacturing capacity for the production of its approved products.
Research and Development. Research and development expenses for the three months
ended September 30, 1997 decreased by 12% to $2,147,000 from $2,430,000 for the
same period in 1996. This decrease was primarily due to reductions in personnel
made during the prior year, principally in the clinical and scientific
administration areas, and related costs, such as payroll taxes, and other cost
containment measures taken by the Company.
6
Selling, General and Administrative Expenses. Selling, general and
administrative expenses for the three months ended September 30, 1997, remained
relatively flat at $1,328,000, as compared to $1,276,000 for the same period in
1996.
Other Income/Expense. Other income/expense decreased by $50,000 to $108,000 for
the three months ended September 30, 1997 as compared to $158,000 for the same
period last year. The decrease in other income/expense for the three months
ended September 30, 1997 was attributable to a decrease in interest income due
to a decrease in interest bearing investments.
In February 1997, the Financial Accounting Standards Board issued
Statements of Financial Accounting Standards No. 128 (SFAS 128), "Earnings Per
Share". SFAS 128 establishes standards for computing and presenting earnings per
share. In accordance with the effective date of SFAS 128, the Company will adopt
SFAS 128 as of December 31, 1997. This statement is not expected to have a
material impact on the Company's consolidated financial statements.
Liquidity and Capital Resources
Enzon had $9,604,000 in cash and cash equivalents as of September 30, 1997.
The Company invests its excess cash in a portfolio of high-grade marketable
securities and United States government-backed securities.
The Company's cash reserves as of September 30, 1997 increased by
$1,288,000 from June 30, 1997. The increase in cash reserves was principally due
to $2,500,000 in milestone payments received from Schering-Plough under the
Company's license agreement for PEG-Intron A. The payments were the result of
PEG-Intron A moving into Phase III clinical trials.
The Company's exclusive U.S. marketing rights license with RPR for
ONCASPAR, as amended, (the "Amended RPR License Agreement") provides for a
payment of $3,500,000 in advance royalties, which was received in January 1995.
Royalties due under the Amended RPR License Agreement will be offset against an
original credit of $5,970,000, which represents the royalty advance plus
reimbursement of certain amounts due RPR 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 with the corresponding current
portion included in accrued expenses on the consolidated condensed balance
sheets and will be reduced as royalties are recognized under the agreement.
Through September 30, 1997, an aggregate of $3,708,000 in royalties payable by
RPR has been offset against the original credit.
As of September 30, 1997, 941,808 shares of Series A Cumulative Convertible
Preferred Stock ("Series A Preferred Stock") had been converted into 3,095,683
shares of Common Stock. Accrued dividends on the converted Series A Preferred
Stock in the aggregate of $1,807,000 were settled by the issuance of 233,741
shares of Common Stock. The Company does not presently intend to pay cash
dividends on the Series A Preferred Stock. As of September 30, 1997, there were
$1,625,000 of accrued and unpaid dividends on the Series A Preferred Stock.
Dividends accrue on the outstanding Series A Preferred Stock at the rate of
$216,000 per year.
To date, the Company's sources of cash have been the proceeds from the sale
of its stock through public and private placements, sales of ADAGEN, sales of
ONCASPAR, sales of its products for research purposes, contract research and
development fees, technology transfer and license fees and royalty advances. The
Company's current sources of liquidity are its cash, cash equivalents and
interest earned on such cash reserves, sales of ADAGEN, sales of ONCASPAR, sales
of its products for research purposes and license fees. Management believes that
its current sources of liquidity will be sufficient to meet its anticipated cash
requirements, based on current spending levels, for approximately the next two
and one half years.
Upon exhaustion of the Company's current cash reserves, the Company's
continued operations will depend on its ability to realize significant revenues
from the commercial sale of its products, raise additional funds through equity
or debt financing, or obtain significant licensing, technology transfer or
contract research and development fees. There can be no assurance that these
sales, financings or revenue generating activities will be successful.
7
PART II OTHER INFORMATION
Item 2. Changes in Securities
In August 1997 and September 1997, the Company issued 775 and 10,958 shares
of unregistered Common Stock for aggregate consideration of $3,000 and $50,000,
respectively. These shares were issued to consultants for services rendered to
the Company. The foregoing transactions were consummated as private sales
pursuant to Section 4(2) of the Securities Act of 1933, as amended.
In September 1997, 1,000 shares of the Company's Series A Cumulative
Preferred Stock were converted to 2,272 shares of unregistered Common Stock.
Accrued dividends of $15,000 were settled through the issuance of 1,358 shares
of unregistered Common Stock. The foregoing transaction was consummated as a
private sale pursuant to Section 4(2) of the Securities Act of 1933, as amended.
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(iii) Certificate of Designations, Preferences and Rights of Series D Convertible
Preferred Stock ^^^^3(iii)
10.0 Employment Agreement dated March 25, 1994 with Peter G. Tombros #(10.17)
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)
10.4 Lease Termination Agreement dated March 31, 1995 for
20 Kingsbridge Road and 40 Kingsbridge Road, Piscataway, New Jersey ~(10.6)
10.5 Option Agreement dated April 1, 1995 regarding 20 Kingsbridge Road,
Piscataway, New Jersey ~(10.7)
10.6 Form of Lease - 40 Cragwood Road, South
Plainfield, New Jersey ****(10.9)
10.7 Lease 300A-B Corporate Court, South Plainfield, New Jersey +++(10.10)
10.8 Stock Purchase Agreement dated March 5, 1987
between the Company and Eastman Kodak Company ****(10.7)
10.9 Amendment dated June 19, 1989 to Stock Purchase
Agreement between the Company and
Eastman Kodak Company **(10.10)
10.10 Form of Stock Purchase Agreement between the Company
and the purchasers of the Series A Cumulative
Convertible Preferred Stock +(10.11)
10.11 Amendment to License Agreement and Revised License Agreement
between the Company and RCT dated
April 25, 1985 ++++(10.5)
10.12 Amendment dated as of May 3, 1989 to Revised License Agreement
dated April 25, 1985 between the Company and Research
Corporation **(10.14)
8
10.13 License Agreement dated September 7, 1989 between the Company and
Research Corporation Technologies, Inc. **(10.15)
10.14 Master Lease Agreement and Purchase Leaseback Agreement dated
October 28, 1994 between the Company and Comdisco, Inc. ##(10.16)
10.15 Employment Agreement with Peter G. Tombros dated as of
April 5, 1997 ^^^^(10.15)
10.16 Stock Purchase Agreement dated as of June 30, 1995 ~~~(10.16)
10.17 Securities Purchase Agreement dated as of January 31, 1996 ~~~(10.17)
10.18 Registration Rights Agreements dated as of January 31, 1996 ~~~(10.18)
10.19 Warrants dated as of February 7, 1996 and issued pursuant to the Securities
Purchase Agreement dated as of January 31, 1996 ~~~(10.19)
10.20 Securities Purchase Agreement dated as of March 15, 1996 ^(10.20)
10.21 Registration Rights Agreement dated as of March 15, 1996 ^(10.21)
10.22 Warrant dated as of March 15, 1996 and issued pursuant to the Securities Purchase
Agreement dated as of March 15, 1996 ^(10.22)
10.23 Amendment dated March 25, 1994 to License Agreement dated
September 7, 1989 between the Company and Research Corporation
Technologies, Inc. ^^(10.23)
10.24 Independent Directors' Stock Plan ^^(10.24)
10.25 Stock Exchange Agreement dated February 28, 1997, by and between the
Company and GFL Performance Fund Ltd. ^^^(10.25)
10.26 Agreement Regarding Registration Rights Under Registration Rights Agreement
dated March 10, 1997, by and between the Company and Clearwater Fund IV
LLC ^^^(10.26)
27.0 Financial Data Schedule o
99.0 Factors to Consider in Connection with Forward-Looking Statements ^^^^(99.0)
o Filed herewith.
* 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 exhibits to the Company's Annual Report on Form 10-K
for the fiscal year ended June 30, 1989 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 exhibits to the Company's Registration Statement on
Form S-1 (File No. 2-96279) filed with the Commission 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.
++++ Previously filed as an exhibit to the Company's Annual Report on Form 10-K
for the fiscal year ended June 30, 1985 and incorporated herein by
reference thereto.
# Previously filed as an exhibit to the Company's Current Report on Form 8-K
dated April 5, 1994 and incorporated herein by reference thereto.
9
## Previously filed as an exhibit to the Company's Quarterly Report on Form
10-Q for the quarter ended December 31, 1994 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 Annual Report on Form 10-K
for the fiscal year ended June 30, 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 Quarterly Report on Form
10-Q for the quarter ended March 31, 1997 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, 1997 and incorporated herein by reference
thereto.
(b) Reports on Form 8-K
On August 8, 1997, the Company filed with the Commission a Current
Report on Form 8-K dated August 4, 1997 relating to the advancement of
PEG-Intron A by Schering-Plough Corporation into Phase III clinical trials
for hepatitis C in the United States and Europe. The Company's agreement
with Schering-Plough Corporation provides for a $2.5 million milestone
payment upon this advancement.
10
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 14, 1997 By: /s/ Peter G. Tombros
-----------------------------
Peter G. Tombros
President and Chief Executive
Officer
By: /s/ Kenneth J. Zuerblis
-----------------------------
Kenneth J. Zuerblis
Vice President, Finance and
Chief Financial Officer
(Principal Financial
and Accounting Officer)
11
5
3-MOS
JUN-30-1998
SEP-30-1997
9,603,543
0
2,236,513
0
1,009,276
12,920,345
15,686,182
13,185,086
16,934,636
5,632,878
0
0
1,080
309,134
9,276,612
16,934,636
2,464,634
4,669,743
604,708
4,080,119
0
0
6,438
697,924
0
697,924
0
0
0
697,924
0.02
0.02
