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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
----------------
FORM 10-Q
(Mark One)
|X| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended December 31, 2003
OR
|_| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
Commission file number 0-12957
ENZON PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Its Charter)
Delaware 22-2372868
(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification No.)
685 Route 202/206, Bridgewater, New Jersey 08807
(Address of Principal Executive Offices) (Zip Code)
(908) 541-8600
(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 |_|
Indicate by check mark whether the registrant is an accelerated filer (as
defined in Rule 12b-2 of the Exchange Act).
Yes |X| No |_|
As of February 10, 2004, there were 43,819,246 shares of Common Stock, par
value $.01 per share, outstanding.
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except shares and per share amounts)
December 31, 2003 June 30, 2003
(Unaudited) *
----------------- -------------
ASSETS
Current assets:
Cash and cash equivalents $ 89,164 $ 66,752
Short-term investments 9,867 25,047
Accounts receivable, net 25,175 33,173
Inventories 10,871 11,786
Deferred tax and other current assets 15,998 16,089
--------- ---------
Total current assets 151,075 152,847
--------- ---------
Property and equipment 46,612 43,896
Less: Accumulated depreciation and amortization 13,297 11,303
--------- ---------
33,315 32,593
--------- ---------
Other assets:
Marketable securities 70,409 61,452
Investments in equity securities and convertible note 67,165 56,364
Amortizable intangible assets, net 203,021 211,975
Goodwill 150,985 150,985
Deferred tax and other assets 61,600 62,350
--------- ---------
553,180 543,126
--------- ---------
Total assets $ 737,570 $ 728,566
========= =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 7,772 $ 12,809
Accrued expenses 21,168 21,536
--------- ---------
Total current liabilities 28,940 34,345
--------- ---------
Notes payable 400,000 400,000
Other liabilities 10,429 2,637
--------- ---------
410,429 402,637
--------- ---------
Commitments and contingencies
Stockholders' equity:
Common stock-$.01 par value, authorized 90,000,000 shares;
issued and outstanding 43,819,246 shares at December 31, 2003
and 43,518,359 shares at June 30, 2003 438 435
Additional paid-in capital 324,986 322,488
Accumulated other comprehensive income (loss) 895 (159)
Deferred compensation (6,101) (4,040)
Accumulated deficit (22,017) (27,140)
--------- ---------
Total stockholders' equity 298,201 291,584
--------- ---------
Total liabilities and stockholders' equity $ 737,570 $ 728,566
========= =========
*Condensed from audited financial statements.
The accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
2
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three and Six Months Ended December 31, 2003 and 2002
(In thousands, except per share data)
(Unaudited)
Three months ended Six months ended
December 31, December 31,
------------------------ ------------------------
2003 2002 2003 2002
--------- --------- --------- ---------
Revenues:
Product sales, net $ 27,711 $ 7,811 $ 52,672 $ 14,377
Manufacturing revenue 2,187 733 3,791 733
Royalties 11,547 22,903 25,358 41,321
Contract revenue 253 50 521 134
--------- --------- --------- ---------
Total revenues 41,698 31,497 82,342 56,565
--------- --------- --------- ---------
Costs and expenses:
Cost of sales and manufacturing revenue 11,825 4,265 22,737 6,779
Research and development 7,388 5,692 13,939 9,754
Selling, general and administrative 11,478 7,397 22,687 11,305
Amortization of acquired intangible assets 3,358 1,293 6,716 1,328
Write-down of carrying value of investments -- 27,237 -- 27,237
--------- --------- --------- ---------
Total costs and expenses 34,049 45,884 66,079 56,403
--------- --------- --------- ---------
Operating income (loss) 7,649 (14,387) 16,263 162
--------- --------- --------- ---------
Other income (expense):
Interest and dividend income 706 4,345 1,180 7,798
Interest expense (4,957) (4,957) (9,914) (9,914)
Other, net 101 -- 408 --
--------- --------- --------- ---------
(4,150) (612) (8,326) (2,116)
--------- --------- --------- ---------
Income (loss) before tax provision 3,499 (14,999) 7,937 (1,954)
Income tax provision 1,180 245 2,814 506
--------- --------- --------- ---------
Net income (loss) $ 2,319 $ (15,244) $ 5,123 $ (2,460)
========= ========= ========= =========
Basic earnings (loss) per common share $ 0.05 $ (0.35) $ 0.12 $ (0.06)
========= ========= ========= =========
Diluted earnings (loss) per common share $ 0.05 $ (0.35) $ 0.12 $ (0.06)
========= ========= ========= =========
Weighted average number of common shares
outstanding-basic 43,307 43,011 43,298 42,995
========= ========= ========= =========
Weighted average number of common shares and
dilutive potential common shares outstanding 43,586 43,011 43,591 42,995
========= ========= ========= =========
The accompanying notes are an integral part of these unaudited consolidated
condensed financial statements.
3
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statement of Cash Flows
(In thousands)
(Unaudited)
Six Months Ending
December 31,
------------------------
2003 2002
---- ----
Cash flows from operating activities:
Net income (loss) $ 5,123 $ (2,460)
Adjustments to reconcile net income to net cash provided by
operating activities:
Depreciation and amortization 10,958 2,610
Non-cash expense for issuance of common stock 1,622 213
Non-cash income relating to equity collar arrangement (401) --
Amortization of bond premium/discount (107) 1,983
Non-cash write-down of carrying value of investment -- 27,237
Deferred income taxes 997 --
Changes in operating assets and liabilities 680 5,909
--------- ---------
Net cash provided by operating activities 18,872 35,492
--------- ---------
Cash flows from investing activities:
Purchase of property and equipment (2,726) (3,594)
Purchase of ABELCET business -- (369,120)
Proceeds from sale of marketable securities 27,944 350,318
Maturities of marketable securities -- 53,000
Purchases of marketable securities (21,950) (81,859)
--------- ---------
Net cash provided by (used in) investing activities 3,268 (51,255)
--------- ---------
Cash flows from financing activities:
Proceeds from exercise of common stock options 272 1,262
--------- ---------
Net increase (decrease) in cash and cash equivalents 22,412 (14,501)
Cash and cash equivalents at beginning of period 66,752 113,858
--------- ---------
Cash and cash equivalents at end of period $ 89,164 $ 99,357
========= =========
The accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
4
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes To Condensed Consolidated Financial Statements
(Unaudited)
(1) Organization and Basis of Presentation
The unaudited condensed consolidated financial statements have been
prepared from the books and records of Enzon Pharmaceuticals, Inc. (the
"Company") and its subsidiaries in accordance with accounting principles
generally accepted in the United States of America for interim financial
information pursuant to Rule 10-01 of Regulation S-X. Accordingly, they do not
include all of the information and footnotes required for complete annual
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 current period presentation. Interim results are not
necessarily indicative of the results that may be expected for the year. The
interim consolidated financial statements should be read in conjunction with the
consolidated financial statements and the notes thereto included in the
Company's latest annual report on Form 10-K.
(2) Comprehensive Income
Statement of Financial Accounting Standards ("SFAS") No. 130, "Reporting
Comprehensive Income", requires unrealized gains and losses on the Company's
available-for-sale securities to be included in other comprehensive income.
The following table reconciles net income (loss) to comprehensive income
(loss) (in thousands):
Three months ended Six months ended
December 31, December 31,
---------------------- ----------------------
2003 2002 2003 2002
-------- -------- -------- --------
Net income (loss) $ 2,319 $(15,244) $ 5,123 $ (2,460)
Other comprehensive income:
Unrealized gain (loss) on marketable
securities arising during the
period, net of tax (514) (1,281) (321) 800
Unrealized gain on NPS investment
arising during the period, net of tax -- -- 1,824 --
(see note 13)
Reclassification adjustment
for net gain realized in net
income, net of tax (59) (2,115) (449) (2,115)
-------- -------- -------- --------
Total other comprehensive income (loss) (573) (3,396) 1,054 (1,315)
-------- -------- -------- --------
Comprehensive income (loss) $ 1,746 $(18,640) $ 6,177 $ (3,775)
======== ======== ======== ========
5
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes To Condensed Consolidated Financial Statements
(Unaudited)
(3) New Accounting Pronouncements
In December 2003, the Financial Accounting Standards Board ("FASB") issued
FASB Interpretation No. 46 (revised December 2003) ("FIN46-R"), Consolidation of
Variable Interest Entities, which addresses how a business enterprise should
evaluate whether it has a controlling financial interest in an entity through
means other than voting rights and accordingly should consolidate the entity.
FIN 46-R replaces FASB Interpretation No. 46, Consolidation of Variable Interest
Entities ("FIN 46"), which was issued in January 2003. FIN 46-R requires that if
an entity has a controlling financial interest in a variable interest entity,
the assets, liabilities and results of activities of the variable interest
entity should be included in the consolidated financial statements of the
entity. The provisions of FIN 46-R are effective immediately to those entities
that are considered to be special-purpose entities. For all other arrangements,
the FIN 46-R provisions are required to be adopted at the beginning of the first
interim or annual period ending after March 15, 2004. As of December 31, 2003
the Company is not a party to transactions contemplated under FIN 46-R.
In November 2002, the Emerging Issues Task Force ("EITF") reached a
consensus opinion on EITF 00-21, Revenue Arrangements with Multiple
Deliverables. The consensus provides that revenue arrangements with multiple
deliverables should be divided into separate units of accounting if certain
criteria are met. The consideration for the arrangement should be allocated to
the separate units of accounting based on their relative fair values, with
different provisions if the fair value of all deliverables is not known or if
the fair value is contingent on delivery of specified items or performance
conditions. Applicable revenue recognition criteria should be considered
separately for each separate unit of accounting. EITF 00-21 is effective for
revenue arrangements entered into in fiscal periods beginning after June 15,
2003. This adoption did not have any impact on our financial position or results
of operations.
(4) Earnings 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 three and six months ended
December 31, 2003, 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 and
the number of shares issuable upon conversion of certain Series A Preferred
Stock which were outstanding as of December 31, 2002. Due to the net loss
recorded for the three and six months ended December 31, 2002, the exercise or
conversion of approximately 587,000 dilutive potential common shares is not
included for purposes of the diluted loss per share calculation. The number of
shares issuable upon conversion of the Company's 4.5% Convertible Subordinated
Notes due 2008 (the "Notes") and the effect of the vesting of certain restricted
stock using the treasury stock method have not been included as the effect of
their inclusion would be antidilutive. As of December 31, 2003, the Company had
9.3 million dilutive common shares outstanding that could potentially dilute
future earnings per share calculations.
6
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes To Condensed Consolidated Financial Statements
(Unaudited)
The following table reconciles the basic and diluted earnings (loss) per
share calculations (in thousands):
Three months ended Six months ended
December 31, December 31,
--------------------- ---------------------
2003 2002 2003 2002
-------- -------- -------- --------
Net income (loss) $ 2,319 $(15,244) $ 5,123 $ (2,460)
Less: Preferred stock dividends -- 4 -- 7
-------- -------- -------- --------
Net income (loss) available to common
stockholders $ 2,319 $(15,248) $ 5,123 ($ 2,467)
======== ======== ======== ========
Weighted average number of
common shares outstanding - basic 43,307 43,011 43,298 42,995
Effect of dilutive securities:
Assumed exercise of non-
qualified stock options and
restricted stock 279 -- 293 --
-------- -------- -------- --------
Weighted average number of
common shares outstanding and
dilutive potential common shares 43,586 43,011 43,591 42,995
======== ======== ======== ========
(5) Stock Based Compensation
As permitted by Statement of Financial Standards ("SFAS") No. 123,
"Accounting for Stock Based Compensation", the Company accounts for stock-based
compensation arrangements in accordance with the provisions of Accounting
Principals Board ("APB") Opinion No. 25 "Accounting for Stock Issued to
Employees". Compensation expense for stock options issued to employees is based
on the difference on the date of grant between the fair value of the Company's
stock and the exercise price of the option. No stock option-based employee
compensation cost is reflected in net income, as all options granted had
exercise prices equal to the market value of the underlying common stock at the
date of grant.
7
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes To Condensed Consolidated Financial Statements
(Unaudited)
The following table illustrates the effect on net income and earnings per
share if the Company had applied the fair value recognition provisions of SFAS
No. 123 to stock based compensation (in thousands, except per share data):
Three months ended Six months ended
December 31, December 31,
---------------------- ----------------------
2003 2002 2003 2002
-------- -------- -------- --------
Net income (loss) $ 2,319 $(15,244) $ 5,123 $ (2,460)
Less: Preferred stock dividends -- 4 -- 7
-------- -------- -------- --------
Net income available to common
stockholders $ 2,319 (15,248) 5,123 (2,467)
Add: Stock-based employee
compensation expense included in
reported net income, net of related
tax effects 237 136 423 213
Deduct: Total stock-based employee
compensation expense determined
under fair value based method for all
awards, net of related tax effects (2,999) (4,909) (5,284) (7,092)
-------- -------- -------- --------
Pro forma net income (loss) available to common
stockholders $ (443) $(20,021) $ 262 $ (9,346)
======== ======== ======== ========
Earnings (loss) per common share - basic:
as reported $ 0.05 $ (0.35) $ 0.12 $ (0.06)
======== ======== ======== ========
pro forma ($ 0.01) $ (0.47) $ 0.01 $ (0.22)
======== ======== ======== ========
Earnings (loss) per common share - diluted:
as reported $ 0.05 $ (0.35) $ 0.12 $ (0.06)
======== ======== ======== ========
pro forma ($ 0.01) $ (0.47) $ 0.01 $ (0.22)
======== ======== ======== ========
During the six months ended December 31, 2003, the Company issued 240,000
shares of restricted common stock to certain members of management. Total
compensation expense of approximately $2.7 million is being recognized over a
five year period.
During the six months ended December 31, 2003, the Company granted 466,285
stock options to its employees at an average exercise price of $11.50 under its
stock option plans (fair value on the date of grants). The options vest over a
period of four years.
6) Inventories
The composition of inventories is as follows (in thousands):
December 31, 2003 June 30, 2003
----------------- -------------
Raw materials $ 4,307 $ 4,349
Work in process 3,674 3,392
Finished goods 2,890 4,045
------- -------
$10,871 $11,786
======= =======
8
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes To Condensed Consolidated Financial Statements
(Unaudited)
(7) Acquisition of the ABELCET Product Line
On November 22, 2002, the Company acquired the North American rights and
operational assets associated with the development, manufacture, sales and
marketing of ABELCET(R) (Amphotericin B Lipid Complex Injection) (the "ABELCET
Product Line") from Elan Corporation, plc, for $360.0 million plus acquisition
costs of approximately $9.3 million.
The following unaudited pro forma results of operations of the Company for
the three and six month period ended December 31, 2002, assumes the acquisition
of the ABELCET Product Line occurred as of July 1, 2002 and assumes the purchase
price has been allocated to the assets purchased based on fair values at the
date of acquisition (in thousands, except per share amounts):
Three months ended Six months ended
December 31, December 31,
2002 2002
------------------ ----------------
Product Sales, net $ 18,899 $ 40,967
Total revenues 41,852 82,422
Net income (loss) (24,125) (16,629)
Pro forma earnings (loss) per share:
Basic $ (0.56) $ (0.38)
Diluted $ (0.56) $ (0.38)
(8) Intangible Assets
The Company's intangible assets are primarily related to its November 22,
2002 acquisition of the ABELCET Product Line, DEPOCYT and ONCASPAR and are
amortized over their estimated useful lives. The gross carrying amount,
estimated lives and accumulated amortization, by major intangible asset class at
December 31, 2003 were as follows:
Gross
Estimated Carrying Accumulated Net
Lives Amount Amortization Assets
--------- -------- ------------- ------
Product patented technology 12 years $ 64,400 $ 5,814 $ 58,586
Manufacturing patent 12 years 18,300 1,652 16,648
NDA Approval 12 years 31,100 2,808 28,292
Trade name and other
product rights 15 years 80,000 5,778 74,222
Product acquisition costs 10-14 years 26,194 2,719 23,475
Patents 1-5 years 2,092 1,700 392
Manufacturing contract 3 years 2,200 794 1,406
-------- ------- --------
Total $224,286 $21,265 $203,021
======== ======= ========
Amortization of intangible assets for the three and six month period ended
December 31, 2003 was $4.5 million and $9.0 million respectively a portion of
which is included in cost of goods sold. Assuming no changes in the
9
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes To Condensed Consolidated Financial Statements
(Unaudited)
gross carrying amount of intangible assets, the amortization of intangible
assets for the next five fiscal years is estimated to be approximately $17.9
million per year. Amortization of intangible assets for both the three and six
month period ended December 31, 2002 was $1.6 million and $1.8 million,
respectively.
(9) Goodwill
The amount assigned to goodwill in connection with the ABELCET Product
Line acquisition was recorded at $151.0 million. In accordance with SFAS No.
142, "Goodwill and Other Intangible Assets," goodwill is not amortized, but
rather is reviewed at least annually for impairment.
(10) 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 $9.0 million for the six months ended December 31,
2003 and 2002. Income tax payments for the six months ended December 31, 2003
were $3.2 million. There were no income tax payments made for the six months
ended December 31, 2002.
(11) Income Taxes
The Company recognized a tax provision for the six months ended December
31, 2003 at an estimated annual effective tax rate of 35%, which is based on the
projected income tax expense and taxable income for the fiscal year ending June
30, 2004. During the three months ended December 31, 2003, the Company reduced
the effective tax rate from 36% to 35%, based on the revised estimate of the
full year effective tax rate. The impact of this change in the effective tax
rate was recognized in the three months ended December 31, 2003.
At June 30, 2003, the Company recognized approximately $67.5 million as a
net deferred tax asset related to expected future profits, because management
concluded that it is more likely than not that the deferred tax assets will be
realized, including the net operating losses from operating activities and stock
option exercises, based on future operations. As of June 30, 2003 and December
31, 2003, the Company retained a valuation allowance of $12.8 million and $13.4
million, respectively, with respect to certain capital losses and federal
research and development credits as the ultimate utilization of such losses and
credits is uncertain. The Company will continue to reassess the need for such
valuation allowance based on the future operating performance of the Company.
The tax provision for the three and six month period ended December 31,
2002 represents the Company's anticipated Alternative Minimum Tax liability
based on the anticipated taxable income for the full fiscal year.
During the three and six month period ended December 31, 2003, the Company
received $254,000 for the sale of certain New Jersey state net operating loss
carryforwards and also purchased certain New Jersey state net operating loss
carryforwards for $1.5 million.
(12) Business Segments
A single management team that reports to the Chief Executive Officer
comprehensively manages the 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 and Canada. 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 SFAS No. 131, "Disclosures about Segments of an Enterprise and
Related Information".
10
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes To Condensed Consolidated Financial Statements
(Unaudited)
(13) Derivative Instruments
In August 2003, the Company entered into a Zero Cost Protective Collar
arrangement (the "Collar") with a financial institution to reduce the exposure
associated with the 1.5 million shares of common stock of NPS Pharmaceuticals,
Inc. ("NPS") it received as part of the merger termination agreement between the
Company and NPS. By entering into this equity collar arrangement and taking into
consideration the underlying put and call option strike prices, the terms are
structured so that the Company's investment in NPS stock, when combined with the
value of the Collar, should secure ultimate cash proceeds in the range of
85%-108% of the negotiated fair value per share of $23.47 (representing a 4.85%
discount off of the closing price of NPS common stock on the day before the
Company executed the Collar). The Collar is considered a derivative hedging
instrument under SFAS No. 133 and as such, the Company periodically measures its
fair value and recognizes the derivative as an asset or a liability. The change
in fair value is recorded in other comprehensive income (See Note 2) or in the
Statement of Operations depending on its effectiveness. As of December 31, 2003,
the market value of NPS' common stock was $30.86 per share. When the underlying
shares become unrestricted and freely tradable, the Company is required to
deliver to the financial institution as posted collateral, a corresponding
number of shares of NPS common stock. During the three and six month period
ended December 31, 2003, the Company sold and re-purchased 375,000 shares of
common stock of NPS. The unrealized gain previously recognized under other
comprehensive income with respect to these shares aggregating $600,000 was
recognized in the Statements of Operations for three and six months ended
December 31, 2003 and is being shown as "Other Income". With respect to the
remaining 1,125,000 shares of NPS common stock, the increase in the aggregate
value above the base price of $23.47 per share up to the $25.35 per share Collar
limit, or $2.2 million, has been recorded in comprehensive income for the six
months ended December 31, 2003, net of income taxes. The fair value of the
Collar above the 25.35 per share dollar limit represented a liability of $8.3
million at December 31, 2003, which is included under "Other Liabilities" in the
Condensed Consolidated Balance Sheet. In addition, the difference in the fair
value of the Collar compared to the fair market value of the NPS common stock
representing a loss of $199,000 and $506,000 for the three and six month period
ended December 31, 2003, respectively, was recorded as "Other Income" in the
Statement of Operations. The Collar will mature in four separate three-month
intervals beginning November 2004 through August 2005, at which time the Company
will receive the proceeds from the sale of the securities. The amount due at
each maturity date will be determined based on the market value of NPS' common
stock on such maturity date. The contract requires the Company to maintain a
minimum cash balance of $30.0 million and additional collateral up to $10.0
million (as defined) under certain circumstances with the financial institution.
The strike prices of the put and call options are subject to certain adjustments
in the event the Company receives a dividend from NPS.
(14) Amendments to Incentive Stock Option Plan
In December 2003, the stockholders of the Company approved amendments to
the Company's 2001 Incentive Stock Plan ("Plan") to increase the number of
shares of common stock available for issuance under the Plan from 2,000,000 to
6,000,000 and to limit the maximum number of shares of restricted stock and
restricted stock units that may be granted under the Plan to 50% of the total
number of shares available for issuance.
11
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes To Condensed Consolidated Financial Statements
(Unaudited)
(15) Subsequent Events
In January 2004, the Company and INEX Pharmaceuticals Corporation ("INEX")
entered into a strategic partnership to develop and commercialize INEX's
proprietary oncology product Onco TCS. The Company and INEX entered into a
Product Supply Agreement, a Development Agreement, and a Co-Promotion Agreement.
The agreements contain cross termination provisions under which termination of
one agreement triggers termination of all the agreements.
Under the terms of the agreements, the Company received the exclusive
commercialization rights for Onco TCS for all indications in the United States,
Canada and Mexico. The lead indication for Onco TCS is relapsed aggressive
non-Hodgkin's lymphoma (NHL) for which INEX is in the process of submitting a
"rolling" New Drug Application (NDA) to the United States Food and Drug
Administration (FDA), which is expected to be completed during the first quarter
of calendar year 2004. The product is also in numerous phase II clinical trials
for several other cancer indications, including first-line NHL.
Upon execution of the related agreements the Company made a $12.0 million
up-front payment to INEX. Such amount will be reflected as an expense related to
acquisition of in-process research and development in the Company's Statement of
Operations for the quarter ending March 31, 2004. In addition, the Company will
be required to pay up to $20.0 million upon Onco TCS being approved by the FDA.
Additional development milestones and sales based bonus payments could total
$43.75 million, of which $10.0 million is payable upon annual sales first
reaching $125.0 million, and $15.0 million is payable upon annual sales first
reaching $250.0 million. The Company will also be required to pay INEX a
percentage of commercial sales of Onco TCS and this percentage will increase as
sales reach certain predetermined thresholds.
The Company and INEX will share equally the future development costs to
obtain and maintain marketing approvals in North America for Onco TCS, and the
Company will pay all sales and marketing costs and certain other post-approval
clinical development costs typically associated with commercialization
activities. The Company plans to market Onco TCS to the oncology market through
its North American sales force, which currently markets ABELCET(R), ONCASPAR(R),
and DEPOCYT(R). INEX has the option of complementing the Company's sales efforts
by co-promoting Onco TCS through the formation of a dedicated North American
sales and medical science liaison force. The costs of building INEX's
co-promotion force will be shared equally by both companies and the Company will
record all sales in the licensed territories. INEX retains manufacturing rights
and the Company will reimburse INEX for the manufacture and supply of the drug
at manufacturing cost plus five percent.
The agreements will expire on a country by country basis upon the
expiration of the last patent covering the licensed product in each particular
country or 15 years after the first commercial sale in such country, whichever
is later. The agreements are also subject to earlier termination under various
circumstances. The Company may terminate the agreements at any time upon 90 days
notice, in connection with which the Company must pay a $2.0 million termination
fee, unless such termination occurs more than 12 months after the agreements
were executed, but before INEX has completed the submission of its NDA to the
FDA for the lead indication. In addition, if at any time the Company determines
that it has no interest in commercializing the product in any country, then INEX
may terminate the agreement with respect to such country. Either party may
terminate the agreements upon a material breach and failure to cure by the other
party. In addition, either party may terminate the agreements upon the other
party's bankruptcy. Generally, the termination of the agreements with respect to
a particular country shall terminate the Company's license with respect to Onco
TCS, and preclude the Company from marketing the product, in that country.
However, if the Company terminates the agreements because of INEX's breach or
bankruptcy, INEX will be obligated to provide the Company a right of reference
to INEX's regulatory dossiers and facilitate a transfer to the Company of the
technology necessary to manufacture the product. In addition, after such
termination, INEX will be obligated to exercise commercially reasonable efforts
to ensure that the Company has a continuous supply of product until the Company,
exercising commercially reasonable efforts, has secured an alternative source of
supply.
Subsequent to December 31, 2003, the Company converted 11,395 shares of
it's Nektar Therapeutics
12
convertible preferred stock resulting in gross proceeds of approximately $9.5
million and a net gain of approximately $5.9 million.
13
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. These forward looking statements are subject to various risks and
uncertainties that may cause actual results to differ materially from the
results predicted by the forward looking statements. The matters set forth in
the "Risk Factors" section of the Company's Annual Report on Form 10-K for the
fiscal year ended June 30, 2003, which is incorporated herein by reference,
contain cautionary statements identifying important risks, uncertainties and
other factors, that could prevent the future results indicated in such
forward-looking statements from being achieved. Other factors could also cause
actual results to vary materially from the future results indicated in such
forward-looking statements.
Acquisition of ABELCET(R) Business
On November 22, 2002, we acquired the North American rights and
operational assets associated with the development, manufacture, sales and
marketing of ABELCET(R) (Amphotericin B Lipid Complex Injection) ("the ABELCET
Product Line") from Elan Corporation, plc ("Elan") for $360.0 million, plus
approximately $9.3 million of acquisition costs. This transaction was accounted
for as a business combination.
Unless otherwise indicated, the discussions in Management's Discussion and
Analysis of Financial Condition and Results of Operations for the three and six
months ended December 31, 2003 and financial condition at December 31, 2003
include the results of operations of the ABELCET Product Line. Comparisons are
made to the results of operations and the financial condition for the three and
six months ended December 31, 2002, which include approximately only one month
of operations, of the ABELCET Product Line commencing from our acquisition of
the Product Line on November 22, 2002.
Liquidity and Capital Resources
Total cash reserves, which include cash, cash equivalents, short-term
investments, and marketable securities, were $169.4 million as of December 31,
2003, as compared to $153.3 million as of June 30, 2003. The increase is
primarily due to the positive cash flow from operations. We invest our excess
cash primarily in United States government-backed securities and
investment-grade corporate debt securities.
During the six months ended December 31, 2003, net cash generated from
operating activities was $18.9 million, compared to $35.5 million for the six
months ended December 31, 2002. The reduction in net cash generated from
operating activities in 2003 compared to 2002 was primarily due to a reduction
in net income related to the deduction of a non-cash writedown of the carrying
value of investments in 2002. During the six months ended December 31, 2002, we
recorded as a non-cash writedown of approximately $27.2 million of our
investment in Nektar Therapeutics.
Cash provided by investing activities totaled $3.3 million for the six
months ended December 31, 2003 compared to cash utilization of $51.3 million for
the six months ended December 31, 2002. Cash provided by investing activities
during the six months ended December 31, 2003, was principally due to net
proceeds from marketable securities of $6.0 million offset by $2.7 million of
capital expenditures.
As of December 31, 2003, we had $400.0 million 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. Accrued interest
on the notes was $9.0 million as of December 31, 2003. 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
14
on July 1, 2008 unless earlier converted, redeemed at our option or redeemed at
the option of the note-holder 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.
In August 2003, we entered into a Zero Cost Protective Collar arrangement
with a financial institution to reduce the exposure associated with the 1.5
million shares of common stock of NPS we received as part of the merger
termination agreement with NPS. By entering into this equity collar arrangement
and taking into consideration the underlying put and call option strike prices,
the terms are structured so that our investment in NPS stock, when combined with
the value of the Collar, should secure ultimate cash proceeds in the range of
85%-108% of the negotiated fair value per share of $23.47 (representing a 4.85%
discount off of the closing price of NPS common stock on the day before we
executed the Collar). The Collar is considered a derivative hedging instrument
under SFAS No. 133 and as such, we periodically measure its fair value and
recognizes the derivative as an asset or a liability. The change in fair value
is recorded in other comprehensive income (See Note 2) or in the Statement of
Operations depending on its effectiveness. As of December 31, 2003, the market
value of NPS' common stock was $30.86 per share. When the underlying shares
become unrestricted and freely tradable, we are required to deliver to the
financial institution as posted collateral, a corresponding number of shares of
NPS common stock. During the three and six month period ended December 31, 2003,
we sold and re-purchased 375,000 shares of common stock of NPS. The unrealized
gain previously recognized under other comprehensive income with respect to
these shares aggregating $600,000 was recognized in the Statements of Operations
for three and six months ended December 31, 2003 and is being shown as "Other
Income". With respect to the remaining 1,125,000 shares of NPS common stock, the
increase in the aggregate value above the base price of $23.47 per share up to
the $25.35 per share Collar limit, or $2.2 million, has been recorded in
comprehensive income for the six months ended December 31, 2003, net of income
taxes. The fair value of the Collar above the 25.35 per share Collar limit
represented a liability of $8.3 million at December 31, 2003, which is included
under "Other Liabilities" in the Condensed Consolidated Balance Sheet. In
addition, the difference in the fair value of the Collar compared to the fair
market value of the NPS common stock of $199,000 and $506,000 for three and six
month period ended December 31, 2003, respectively, was recorded as "Other
Income" in the Statement of Operations. The Collar will mature in four separate
three-month intervals beginning November 2004 through August 2005, at which time
we will receive the proceeds from the sale of the securities. The amount due at
each maturity date will be determined based on the market value of NPS' common
stock on such maturity date. The contract requires us to maintain a minimum cash
balance of $30.0 million and additional collateral up to $10.0 million (as
defined) under certain circumstances with the financial institution. The strike
prices of the put and call options are subject to certain adjustments in the
event we receive a dividend from NPS.
Our current sources of liquidity are our cash reserves, and interest
earned on such cash reserves, short-term investments, marketable securities,
sales of ADAGEN(R), ONCASPAR(R), DEPOCYT(R) and ABELCET(R), royalties earned
primarily on sales of PEG-INTRON(R), sales of our products for research purposes
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 and expected cash flow from operations will be
sufficient to meet our capital, debt service and operational requirements for
the foreseeable future.
During January 2004, we entered into a strategic partnership to develop
and commercialize INEX Pharmaceuticals Corporation's ("INEX") proprietary
oncology product, Onco TCS. Under the terms of the agreements, we obtained the
exclusive commercialization rights for Onco TCS for all indications in the
United States, Canada and Mexico. The lead indication for Onco TCS is relapsed
aggressive non-Hodgkin's lymphoma (NHL) for which INEX is in the process of
submitting a "rolling" New Drug Application (NDA) to the United States Food and
Drug Administration (FDA), which is expected to be completed during the first
quarter of calendar year 2004. The product is also in numerous phase II clinical
trials for several other cancer indications, including first-line NHL.
Under the agreement, we paid INEX a $12.0 million up-front payment and
will pay up to a $20.0 million payment upon Onco TCS receiving approval from the
FDA. Additional development milestones and sales based bonus payments could
total $43.75 million, of which $10.0 million is payable upon annual sales first
reaching $125.0 million
15
and $15.0 million is payable upon annual sales first reaching $250.0 million.
INEX will also receive a percentage of commercial sales of Onco TCS and this
percentage will increase as sales reach certain predetermined thresholds.
While we believe that our cash, cash reserves and investments will be
adequate to satisfy our capital needs 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.
Off-Balance Sheet Arrangements
As part of our ongoing business, we do not participate in transactions
that generate relationships with unconsolidated entities or financial
partnerships, such as entities often referred to as structured finance or
special purpose entities ("SPE"), which would have been established for the
purpose of facilitating off-balance sheet arrangements or other contractually
narrow limited purposes. As of December 31, 2003, we are not involved in any
material unconsolidated SPE transactions.
Contractual Obligations
Our major outstanding contractual obligations relate to our operating
leases, our convertible debt and our license and development agreements with
collaborative partners. Other than the additional contractual obligations under
our strategic partnership with INEX discussed under "Liquidity and Capital
Resources " and in Note 15 of the Notes to our unaudited quarterly financial
statements, our contractual obligations as of December 31, 2003 are not
materially different from our contractual obligations as of June 30, 2003 as
disclosed under "Management's Discussion and Analysis of Financial Condition and
Results of Operations - Contractual Obligations" in our annual report on Form
10-K for the fiscal year ended June 30, 2003.
Results of Operations
Three months ended December 31, 2003 and December 31, 2002
Revenues. Total revenues for the three months ended December 31, 2003
increased by 32% to $41.7 million, as compared to $31.5 million for the three
months ended December 31, 2002. The components of revenues are product sales and
certain contract manufacturing revenues, royalties we earn on the sale of
products by others and contract revenues.
Net product sales and manufacturing revenue increased by 250% to $29.9
million for the three months ended December 31, 2003, as compared to $8.5
million for the three months ended December 31, 2002. The increase in net sales
was due to the commencement of sales of ABELCET in North America in November
2002, the commencement of sales of DEPOCYT in January 2003, and increased sales
of ONCASPAR. During November 2002, we acquired the ABELCET Product Line from
Elan. During the three months ended December 31, 2003, we recorded $20.3 million
of sales related to the ABELCET Product Line as compared to $1.3 million for the
corresponding period in the prior year. Of the total ABELCET Product Line sales,
sales in North America accounted for $18.0 million for the three months ended
December 31, 2003 as compared to $588,000 for the three months ended December
31, 2002. Contract manufacturing revenue related to the manufacture and sale of
ABELCET to Elan for the international market and other contract manufacturing
revenue was $2.2 million for the three month period ended December 31, 2003 as
compared to $733,000 for the three months ended December 31, 2002. In January
2003, we obtained an exclusive license to sell, market, and distribute
SkyePharma's DEPOCYT. During the three months ended December 31, 2003, we
recorded DEPOCYT sales of $1.3 million. Sales of ONCASPAR increased by 40% to
$4.4 million for the three months ended December 31, 2003 from $3.1 million in
the corresponding period in the prior year. This was a result of our resumption
of marketing efforts in connection with our reacquiring from Aventis in June
2002 the right to market and distribute ONCASPAR for certain territories
previously licensed to Aventis. Sales of ADAGEN decreased by 3% for the three
months ended December 31, 2003 to $4.0 million as compared to $4.1 million for
the three months ended December 31, 2002 due to the timing
16
of shipments.
Royalties for the three months ended December 31, 2003, decreased to $11.5
million as compared to $22.9 million in the same period in the prior year. The
decrease was primarily due to decreased sales of PEG-INTRON by Schering-Plough,
our marketing partner, due to the introduction of a competitive product,
PEGASYS(R).
During December 2002, Hoffman-LaRoche launched PEGASYS(R), a pegylated
version of its interferon product ROFERON-A(R). Since its launch, PEGASYS has
taken market share away from PEG-INTRON. As a result, quarterly sales of
PEG-INTRON and the royalties we receive on those sales have declined in recent
quarters. We have no involvement in the marketing and sales of PEG-INTRON, which
are the responsibility of Schering-Plough. We cannot assure you that PEGASYS
will not continue to gain market share at the expense of PEG-INTRON, which could
result in lower PEG-INTRON sales and lower royalties.
As a result of our focused marketing efforts for ABELCET, we believe that
we have been able to stabilize the pressure from the introduction of new
products in the antifungal market and that the product is now back on a growth
pattern. We expect sales of DEPOCYT, which are currently running at an annual
rate of approximately $5.0 million, to increase as we continue to roll out our
focused marketing efforts. We expect ADAGEN and ONCASPAR sales to grow in this
fiscal year at levels similar to those achieved during the last fiscal year.
However, we cannot assure you that any particular sales levels of ABELCET,
ADAGEN, ONCASPAR, DEPOCYT or PEG-INTRON will be achieved or maintained.
Contract revenues for the three months ended December 31, 2003, increased
to $253,000 as compared to $50,000 in the corresponding period in the previous
year. The increase was related to revenue received from the licensing of our PEG
technology to SkyePharma. In connection with such licensing, we received a
payment of $3.5 million in January 2003 which is being recognized as revenue
over the term of the related agreement.
During the three months ended December 31, 2003, we had export sales and
royalties on export sales of $8.7 million, of which $7.2 million were sales in
Europe or royalties on sales in Europe. Export sales and royalties recognized on
export sales for the three months ended December 31, 2002 were $7.5 million, of
which $6.8 million were in Europe.
Cost of Sales and Manufacturing Revenue. Cost of sales and manufacturing
revenue, as a percentage of net sales and manufacturing revenue decreased to 40%
for the three months ended December 31, 2003 as compared to 50% for the same
period last year. The decrease was due to certain purchase accounting
adjustments to the inventory acquired with the ABELCET Product Line, which was
sold during the six months ended December 31, 2002.
Research and Development. Research and development expenses increased by
30% to $7.4 million for the three months ended December 31, 2003 from $5.7
million for the same period last year. The increase was primarily due to (i)
increased spending of approximately $900,000 related to our single chain
antibody collaboration with Micromet AG, (ii) increased spending on our two late
stage development programs, PEG-Camptothecin and ATG Fresenius S, of
approximately $400,000, and (iii) increased payroll related expenses of
approximately $400,000.
Selling, General and Administrative. Selling, general and administrative
expenses for the three months ended December 31, 2003 increased by 55% to $11.5
million, as compared to $7.4 million in the same period last year. The increase
was primarily due to (i) increased sales and marketing expense of approximately
$3.3 million related to the sales force acquired from Elan as part of our
acquisition of the ABELCET Product Line, and (ii) increased sales and marketing
expense of approximately $800,000 related to the establishment of an oncology
sales force for ONCASPAR and DEPOCYT.
Amortization. Amortization expense increased to $3.4 million for the three
months ended December 31, 2003 as compared to $1.3 million in the comparable
period last year as a result of the amortization of the intangible assets
acquired in November 2002 as part of the ABELCET Product Line. Amortization of
intangible assets is provided over
17
their estimated lives ranging from 1-15 years on a straight-line basis.
Other Income/Expense. Interest and dividend income for the three months
ended December 31, 2003 decreased to $706,000, as compared to $4.3 million for
the prior year. The decrease was primarily due to a reduction in our
interest-bearing investments resulting from our purchase of the ABELCET Product
Line in November 2002 for a cash payment of $360.0 million, plus acquisition
costs, as well as a decrease in interest rates. Interest expense remained
unchanged from the comparable period last year. Interest expense is related to
the $400.0 million in 4.5% convertible subordinated notes, which were
outstanding for both periods. Other income of $102,000 for the three months
ended December 31, 2003, primarily represents the gain realized pursuant to the
sale and re-purchase of 375,000 shares of NPS common stock partially offset by
loss recognized with respect to the collar associated with the 1.5 million
shares of NPS common stock we hold.
Income Taxes. During the three months ended December 31, 2003 and 2002 we
recognized net tax expense of approximately $1.2 million and $245,000,
respectively. We recognized a tax provision for the three months ended December
31, 2003 at an estimated annual effective tax rate of 35%, which is based on the
projected income tax expense and taxable income for the fiscal year ending June
30, 2004. The tax provision for the three months ended December 31, 2002
represents our anticipated Alternative Minimum Tax liability based on the
anticipated taxable income for the full fiscal year.
At June 30, 2003, we recognized approximately $67.5 million as a net
deferred tax asset related to expected future profits, since management
concluded that it is more likely than not that the deferred tax assets will be
realized, including the net operating losses from operating activities and stock
option exercises, based on future operations. As of December 31, 2003, we
retained a valuation allowance of $13.4 million with respect to certain capital
losses and credits and will continue to reassess the need for such valuation
allowance based on the future operating performance of the Company.
Six months ended December 31, 2003 and December 31, 2002
Revenues. Total revenues for the six months ended December 31, 2003
increased by 46% to $82.3 million, as compared to $56.6 million for the six
months ended December 31, 2002. The components of revenues are product sales and
certain contract manufacturing revenues, royalties we earn on the sale of
products by others and contract revenues.
Net product sales and manufacturing revenue increased by 274% to $56.5
million for the six months ended December 31, 2003, as compared to $15.1 million
for the six months ended December 31, 2002. The increase in net sales was due to
the commencement of sales of ABELCET in North America in November 2002, the
commencement of sales of DEPOCYT in January 2003, and increased sales of ADAGEN
and ONCASPAR. During November 2002, we acquired the ABELCET Product Line from
Elan. During the six months ended December 31, 2003, we recorded $36.8 million
of sales related to the ABELCET Product Line as compared to $1.3 million for the
prior year. Of the total ABELCET Product Line sales, sales in North America
accounted for $33.0 million for the six months ended December 31, 2003 as
compared to $588,000 for the six months ended December 31, 2002. Contract
manufacturing revenue related to the manufacture and sale of ABELCET to Elan for
the international market and other contract manufacturing revenue was $3.8
million for the six month period ended December 31, 2003 as compared to $733,000
for the comparable period of the prior year. In January 2003, we obtained an
exclusive license to sell, market and distribute SkyePharma's DEPOCYT. During
the six months ended December 31, 2003, we recorded DEPOCYT sales of $2.6
million. Sales of ONCASPAR increased by 44% to $8.4 million for the six months
ended December 31, 2003 from $5.9 million in the corresponding period in the
prior year. This was a result of our resumption of marketing efforts in
connection with reacquiring from Aventis in June 2002, the right to market and
distribute ONCASPAR for certain territories we previously licensed to Aventis.
Sales of ADAGEN increased by 9% for the six months ended December 31, 2003 to
$8.7 million as compared to $7.9 million for the six months ended December 31,
2002 due to an increase in the number of patients receiving the drug.
18
Royalties for the six months ended December 31, 2003, decreased to $25.4
million as compared to $41.3 million in the same period in the prior year. The
decrease was primarily due to decreased sales of PEG-INTRON by Schering-Plough,
our marketing partner, due to the introduction of a competitive product,
PEGASYS.
Contract revenues for the six months ended December 31, 2003 increased to
$521,000 as compared to $134,000 in the corresponding period in the previous
year. The increase was related to revenue received from the licensing of our PEG
technology to SkyePharma. In connection with such licensing, we received a
payment of $3.5 million in January 2003 which is being recognized as revenue
over the term of the related agreement.
During the six months ended December 31, 2003, we had export sales and
royalties on export sales of $18.2 million, of which $15.5 million were sales in
Europe or royalties on sales in Europe. Export sales and royalties recognized on
export sales for the corresponding period in the prior year were $15.6 million,
of which $14.0 million were in Europe.
Cost of Sales and Manufacturing Revenue. Cost of sales and manufacturing
revenue, as a percentage of net sales and manufacturing revenue decreased to 40%
for the six months ended December 31, 2003 as compared to 45% for the comparable
period last year. The decrease was due to certain purchase accounting
adjustments to the inventory acquired with the ABELCET Product Line, which was
sold during six months ended December 31, 2002.
Research and Development. Research and development expenses increased by
43% to $13.9 million for the six months ended December 31, 2003 from $9.8
million for the comparable period last year. The increase was primarily due to
(i) increased spending of approximately $1.6 million related to our single chain
antibody collaboration with Micromet AG, (ii) increased spending on our two late
stage development programs, PEG-Camptothecin and ATG Fresenius S, of
approximately $1.4 million, (iii) increased payroll related expenses of
approximately $1.0 million and (iv) increased other expenses of approximately
$100,000 related to our internal research and preclinical activities.
Selling, General and Administrative. Selling, general and administrative
expenses for the six months ended December 31, 2003 increased by 101% to $22.7
million, as compared to $11.3 million in the comparable period last year. The
increase was primarily due to (i) increased sales and marketing expense of
approximately $9.7 million related to the sales force acquired from Elan as part
of our acquisition of the ABELCET Product Line, (ii) increased sales and
marketing expense of approximately $1.6 million related to the establishment of
an oncology sales force for ONCASPAR and DEPOCYT and (iii) increased general and
administrative personnel and other costs of approximately $100,000.
Amortization. Amortization expense increased to $6.7 million for the six
months ended December 31, 2003 as compared to $1.3 million in the same period
last year as a result of the amortization of the intangible assets acquired in
November 2002 as part of the ABELCET Product Line. Amortization of intangible
assets is provided over their estimated lives ranging from 1-15 years on a
straight-line basis.
Other Income/Expense. Interest and dividend income for the six months
ended December 31, 2003 decreased to $1.2 million, as compared to $7.8 million
for the prior year. The decrease was primarily due to a reduction in our
interest-bearing investments resulting from our purchase of the ABELCET Product
Line in November 2002 for a cash payment of $360.0 million, plus acquisition
costs, as well as a decrease in interest rates. Interest expense remained
unchanged from the comparable period last year. Interest expense is related to
the $400.0 million in 4.5% convertible subordinated notes, which were
outstanding for both periods. Other income of $408,000 for the six months ended
December 31, 2003, mostly represents the gain realized pursuant to the sale and
re-purchase of 375,000 shares of NPS common stock partially offset by a loss
recognized on the Collar arrangement related to the 1.5 million shares of NPS
common stock we hold.
19
Income Taxes. During the six months ended December 31, 2003 and 2002 we
recognized net tax expense of approximately $2.8 million and $506,000,
respectively. We recognized a tax provision for the six months ended December
31, 2003 at an estimated annual effective tax rate of 35%, which is based on the
projected income tax expense and taxable income for the fiscal year ending June
30, 2004. The tax provision for the six months ended December 31, 2002
represents our anticipated Alternative Minimum Tax liability based on the
anticipated taxable income for the full fiscal year
At June 30, 2003, we recognized approximately $67.5 million as a net
deferred tax asset related to expected future profits, since management
concluded that it is more likely than not that the deferred tax assets will be
realized, including the net operating losses from operating activities and stock
option exercises, based on future operations. As of December 31, 2003, we
retained a valuation allowance of $13.4 million with respect to certain capital
losses and credits and will continue to reassess the need for such valuation
allowance based on the future operating performance of the Company.
Critical Accounting Policies
In December 2001, the SEC requested that all registrants discuss their
most "critical accounting policies" in Management's Discussion and Analysis of
Financial Condition and Results of Operations. The SEC indicated that a
"critical accounting policy" is one which is both important to the portrayal of
the company's financial condition and results of operations and requires
management's most difficult, subjective or complex judgments, often as a result
of the need to make estimates about the effect of matters that are inherently
uncertain.
Our consolidated financial statements are presented in accordance with
accounting principles that are generally accepted in the United States. All
professional accounting standards effective as of December 31, 2003 have been
taken into consideration in preparing the consolidated financial statements. The
preparation of the consolidated financial statements requires estimates and
assumptions that affect the reported amounts of assets, liabilities, revenues,
expenses and related disclosures. Some of those estimates are subjective and
complex, and, consequently, actual results could differ from those estimates.
The following accounting policies have been highlighted as significant because
changes to certain judgments and assumptions inherent in these policies could
affect our consolidated financial statements.
Revenues from product sales and manufacturing revenue are recognized based
on shipping terms and a provision is made at that time for estimated future
credits, chargebacks, sales discounts, rebates and returns. These sales
provision accruals are presented as a reduction of the accounts receivable
balances. We continually monitor the adequacy of the accruals by comparing the
actual payments to the estimates used in establishing the accruals. We utilize
the following criteria to determine appropriate revenue recognition: pervasive
evidence of an arrangement exists, delivery has occurred, selling price is fixed
and determinable and collection is reasonably assured.
Royalties under our license agreements with third parties are recognized
when earned through the sale of the product by the licensor net of any estimated
future credits, chargebacks, sales discount rebates and refunds. Since we do not
sell or market the products, we rely on disclosures from our marketing partners
to estimate such sales allowances.
Contract revenues are recorded as the earnings process is completed.
Non-refundable milestone payments that represent the completion of a separate
earnings process are recognized as revenue when earned, upon the occurrence of
contract-specified events and when the milestone has substance. Non-refundable
payments received upon entering into license and other collaborative agreements
where we have continuing involvement are recorded as deferred revenue and
recognized ratably over the estimated service period.
Under the asset and liability method of Statement of Financial Accounting
Standards ("SFAS") No. 109, deferred tax assets and liabilities are recognized
for the estimated future tax consequences attributable to differences between
financial statement carrying amounts of existing assets and liabilities and
their respective tax bases.
20
Deferred tax assets and liabilities are measured using enacted tax rates
expected to apply to taxable income in the years in which those temporary
differences are expected to be recovered or settled. A valuation allowance on
net deferred tax assets is provided for when it is more likely than not that
some portion or all of the deferred tax assets will not be realized. We have
significant net deferred tax assets, primarily related to net operating loss
carryforwards, and continue to analyze the level of the valuation allowance
needed taking into consideration the expected future performance of the Company.
We assess the carrying value of our investments in accordance with SFAS
No. 115 and SEC Staff Accounting Bulletin No. 59. An impairment write-down is
recorded when a decline in the value of an investment is determined to be
other-than-temporary. These determinations involve a significant degree of
judgment and are subject to change as facts and circumstances change.
In accordance with the provisions of SFAS No. 142, goodwill and intangible
assets determined to have an indefinite useful life acquired in a purchase
business combination are not subject to amortization, are tested at least
annually for impairment, and are tested for impairment more frequently if events
and circumstances indicate that the asset might be impaired. Goodwill is
reviewed for impairment by comparing the carrying value to its fair value.
Recoverability of amortizable intangible assets is determined by comparing the
carrying amount of the asset to the future undiscounted net cash flow to be
generated by the asset. The evaluations involve amounts that are based on
management's best estimate and judgment. Actual results may differ from these
estimates. If recorded values are less than the fair values, no impairment is
indicated. SFAS No. 142 also requires that intangible assets with estimated
useful lives be amortized over their respective estimated useful lives.
21
Item 3. 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 investment
grade 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
December 31, 2003 all of our holdings were in instruments maturing in three
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
December 31, 2003 (in thousands):
2004 2005 2006 2007 Total Fair Value
---- ---- ---- ---- ----- ----------
Fixed Rate $ 9,811 $47,194 $18,929 $ 4,500 $80,434 $80,276
Average Interest Rate 2.42% 2.17% 2.23% 2.93% 2.26% --
Variable Rate -- -- -- -- --
Average Interest Rate -- -- -- -- --
------- ------- ------- ------- ------- -------
$ 9,811 $47,194 $18,929 $ 4,500 $80,434 $80,276
======= ======= ======= ======= ======= =======
Our 4.5% convertible subordinated notes in the principal amount of $400.0
million due July 1, 2008 have a fixed interest rate. The fair value of the notes
was approximately $352.0 million at December 31, 2003. 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.
As discussed in Liquidity and Capital Resources, in August 2003, we
entered into a Zero Cost Protective Collar arrangement with a financial
institution to reduce the exposure associated with the 1.5 million shares of
common stock of NPS we received as part of the merger termination agreement with
NPS.
Item 4. Controls and Procedures
(a) Evaluation of disclosure controls and procedures.
Under the supervision and with the participation of our management, including
our Chief Executive Officer and Chief Financial Officer, we evaluated the
effectiveness of the design and operation of our disclosure controls and
procedures (as defined in Rule 13a-15(e) under the Exchange Act) as of December
31, 2003, the end of the period covered by this report (the "Evaluation Date").
Based upon that evaluation, the Chief Executive Officer and Chief Financial
Officer concluded that, as of the Evaluation Date, our disclosure controls and
procedures were effective in timely alerting them to the material information
relating to us required to be included in our periodic SEC filings.
(b) Changes in internal controls over financial reporting.
There were no changes in our internal controls over financial reporting during
the period covered by this report that have materially affected, or are
reasonably likely to materially affect our internal control over financial
reporting.
22
PART II OTHER INFORMATION
Item 4. Submission of Matters to a Vote of Security Holders
(a) An annual meeting of stockholders was held on December 2, 2003.
(b) The directors elected at the annual meeting were Dr. David W. Golde
and Robert L. Parkinson, Jr. The term of office as a director for
each of David S. Barlow, Rolf A. Classon, Arthur J. Higgins, Robert
LeBuhn and Dr. Rosina Dixon continued after the annual meeting. Mr.
Barlow resigned from our Board of directors effective as of January
2, 2004.
(c) The matters voted upon at the annual meeting and the results of the
voting, including broker non-votes where applicable, are set forth
below:
(i) The stockholders voted 34,398,496 shares in favor and
2,090,555 shares withheld with respect to the election of Dr. David
W. Golde as a Class II director of the Company, and 33,811,334
shares in favor and 2,677,717 shares withheld with respect to the
election of Robert L. Parkinson, Jr. as a Class II director of the
Company. Broker non-votes were not applicable.
(ii) The stockholders voted 15,236,400 shares in favor,
9,028,383 shares against and 132,265 shares abstained with respect
to a proposal to approve the amendments to the Company's 2001
Incentive Stock Plan to increase the number of shares of common
stock available for issuance under the 2001 Incentive Stock Plan
from 2,000,000 to 6,000,000 and to limit the maximum number of
shares of restricted stock and restricted stock units that may be
granted under the 2001 Incentive Stock Plan to 50% of the total
number of shares available for issuance under the 2001 Incentive
Stock Plan. Broker non-votes were not applicable.
(iii) The stockholders voted 34,885,438 shares in favor and
1,486,648 shares against and 116,965 shares abstained with respect
to a proposal to ratify the selection of KPMG LLP to audit our
consolidated financial statements for the fiscal year ending June
30, 2004. Broker non-votes were not applicable.
23
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
------ ----------- ------------
3.1 Certificate of Incorporation, as amended ^^^
3.2 Amendment to Certificate of Incorporation \\
3.3 By laws, as amended ^^
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 Notes due 2008 attached as Exhibit A thereto ++++
4.2 Rights Agreement dated May 17, 2002 between the Company and
Continental Stock Transfer Trust Company, as rights agent ^
4.3 First Amendment to Rights Agreement, dated as of February 19, 2003 *
10.23 2001 Incentive Stock Plan, as amended #
10.24 Amendment No. 2 to the Employment Agreement between the Company and
Arthur J. Higgins dated May 23, 2001 #
10.25 Amended and Restated Employment Agreement between the Company and
Ulrich Grau dated as of December 5, 2003. #
10.26 Restricted Stock Award Agreement between the Company and Ulrich
Grau dated as of December 5, 2003. #
31.1 Rule 13a-14(a) Certifications #
31.2 Rule 13a-14(a) Certifications #
32.1 Section 1350 Certifications #
32.2 Section 1350 Certifications #
# Filed herewith.
^^^ Previously filed as an exhibit to the Company's Annual Report on
Form 10-K for the year ended June 30, 2002 and incorporated herein
by reference thereto.
\\ Previously filed as an exhibit to the Company's Current Report on
Form 8-K filed on December 10, 2002 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 May 22, 2002 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 Form 8-A (File No.
000-12957) filed with the Commission on May 22, 2002 and
incorporated herein by reference thereto.
* Previously filed as an exhibit to the Company's Form 8-A12 G/A (File
No. 000-12957) filed with the Commission on February 20, 2003 and
incorporated herein by reference thereto.(b) Reports on Form 8-K.
24
(b) Reports on Form 8-K
On October 22, 2003, we filed with the Commission a Current Report on Form
8-K dated October 22, 2003 updating our financial outlook and withdrawing our
pre-tax net income and EBITA guidance for the fiscal year ending June 30, 2004.
On November 6, 2003, we filed with the Commission a Current Report on Form
8-K dated November 6, 2003 reporting our financial results for the first quarter
of fiscal year 2004 ended September 30, 2003.
On November 12, 2003, we filed with the Commission a Current Report on
Form 8-K dated November 12, 2003 reporting the amendment of our 2001 Incentive
Stock Plan to add the following language to Section 7.B thereof:
"Notwithstanding the foregoing, without the prior approval of Enzon's
stockholders, options issued under this plan will not be repriced, replaced, or
regranted through cancellation, or by lowering the option exercise price of a
previously granted award."
25
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 PHARMACEUTICALS, INC.
(Registrant)
Date: February 17, 2004 By: /s/ Arthur J. Higgins
------------------------------
Arthur J. Higgins
Chairman, President and
Chief Executive Officer
(Principal Executive Officer)
Date: February 17, 2004 By: /s/ Kenneth J. Zuerblis
------------------------------
Kenneth J. Zuerblis
Vice President, Finance,
Chief Financial Officer
(Principal Financial
and Accounting Officer) and
Corporate Secretary
26