ENZON PHARMACEUTICALS, INC. - Quarter Report: 2007 June (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2007
or
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Transition Period from to
Commission file number 0-12957
Enzon Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware (State of incorporation) |
22-2372868 (I.R.S. Employer Identification No.) |
|
685 Route 202/206, Bridgewater, New Jersey (Address of principal executive offices) |
08807 (Zip Code) |
(908) 541-8600
(Registrants telephone number, including area code)
(Registrants telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
(Former name, former address and former fiscal year, if changed since last report)
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 þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated
filer in Rule 12b-2 of the Exchange Act. (Check one):
Large Accelerated Filer o Accelerated Filer þ Non-Accelerated Filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act).
Yes o Noþ
Shares of
Common Stock outstanding as of July 31, 2007: 44,087,603.
TABLE OF CONTENTS
Table of Contents
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
December 31, | ||||||||
June 30, 2007 | 2006* | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 24,224 | $ | 28,431 | ||||
Short-term investments |
127,815 | 145,113 | ||||||
Accounts receivable, net of allowance for doubtful accounts;
$237 at June 30, 2007 and $245 at December 31, 2006 |
14,213 | 15,259 | ||||||
Inventories |
19,415 | 17,618 | ||||||
Other current assets |
7,637 | 5,890 | ||||||
Total current assets |
193,304 | 212,311 | ||||||
Property and equipment, net of accumulated depreciation;
$29,403 at June 30, 2007 and $26,506 at December 31, 2006 |
48,150 | 39,491 | ||||||
Marketable securities |
35,042 | 67,061 | ||||||
Amortizable intangible assets, net |
73,309 | 78,510 | ||||||
Other assets |
5,626 | 6,457 | ||||||
Total assets |
$ | 355,431 | $ | 403,830 | ||||
LIABILITIES AND STOCKHOLDERS DEFICIT |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 9,004 | $ | 24,918 | ||||
Accrued expenses |
18,531 | 34,967 | ||||||
Total current liabilities |
27,535 | 59,885 | ||||||
Notes payable |
381,721 | 397,642 | ||||||
Other liabilities |
2,950 | 2,744 | ||||||
Total liabilities |
412,206 | 460,271 | ||||||
Commitments and contingencies |
||||||||
Stockholders deficit: |
||||||||
Preferred stock $.01 par value, authorized 3,000,000 shares;
no shares issued and outstanding at June 30, 2007 and
December 31, 2006 |
| | ||||||
Common stock $.01 par value, authorized 170,000,000 shares;
issued and outstanding 44,072,110 shares and 43,999,031
shares
at June 30, 2007 and December 31, 2006, respectively |
441 | 440 | ||||||
Additional paid-in capital |
329,993 | 326,099 | ||||||
Accumulated other comprehensive income (loss) |
254 | (414 | ) | |||||
Accumulated deficit |
(387,463 | ) | (382,566 | ) | ||||
Total stockholders deficit |
(56,775 | ) | (56,441 | ) | ||||
Total liabilities and stockholders deficit |
$ | 355,431 | $ | 403,830 | ||||
* | Condensed from audited financial statements. |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(Unaudited)
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(Unaudited)
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2007 | 2006 | 2007 | 2006 | |||||||||||||
Revenues: |
||||||||||||||||
Product sales, net |
$ | 25,019 | $ | 24,537 | $ | 47,668 | $ | 48,812 | ||||||||
Royalties |
18,290 | 17,936 | 34,634 | 35,184 | ||||||||||||
Contract manufacturing |
5,903 | 5,131 | 8,398 | 8,337 | ||||||||||||
Total revenues |
49,212 | 47,604 | 90,700 | 92,333 | ||||||||||||
Costs and expenses: |
||||||||||||||||
Cost of product sales and contract
manufacturing |
16,293 | 12,352 | 27,757 | 22,901 | ||||||||||||
Research and development |
17,739 | 9,466 | 30,979 | 16,469 | ||||||||||||
Selling, general and administrative |
15,225 | 15,247 | 31,415 | 31,085 | ||||||||||||
Amortization of acquired intangible assets |
185 | 185 | 370 | 374 | ||||||||||||
Restructuring charge |
755 | | 1,324 | | ||||||||||||
Total costs and expenses |
50,197 | 37,250 | 91,845 | 70,829 | ||||||||||||
Operating (loss) income |
(985 | ) | 10,354 | (1,145 | ) | 21,504 | ||||||||||
Other income (expense): |
||||||||||||||||
Investment income, net |
2,366 | 3,084 | 4,943 | 18,900 | ||||||||||||
Interest expense |
(4,491 | ) | (6,639 | ) | (9,044 | ) | (11,520 | ) | ||||||||
Other, net |
327 | 4,476 | 417 | 4,235 | ||||||||||||
(1,798 | ) | 921 | (3,684 | ) | 11,615 | |||||||||||
(Loss) income before income tax provision |
(2,783 | ) | 11,275 | (4,829 | ) | 33,119 | ||||||||||
Income tax provision |
261 | 288 | 68 | 424 | ||||||||||||
Net (loss) income |
$ | (3,044 | ) | $ | 10,987 | $ | (4,897 | ) | $ | 32,695 | ||||||
(Loss) earnings per common share basic |
$ | (0.07 | ) | $ | 0.25 | $ | (0.11 | ) | $ | 0.75 | ||||||
(Loss) earnings per common share diluted |
$ | (0.07 | ) | $ | 0.25 | $ | (0.11 | ) | $ | 0.75 | ||||||
Weighted average shares basic |
43,884 | 43,539 | 43,873 | 43,531 | ||||||||||||
Weighted average shares diluted |
43,884 | 43,539 | 43,873 | 43,531 | ||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Six months ended | ||||||||
June 30, | ||||||||
2007 | 2006 | |||||||
Cash flows from operating activities: |
||||||||
Net (loss) income |
$ | (4,897 | ) | $ | 32,695 | |||
Adjustments to reconcile net (loss) income to net cash
(used in) provided by operating activities: |
||||||||
Depreciation and amortization |
8,106 | 6,600 | ||||||
Share-based compensation |
3,605 | 2,544 | ||||||
Gain on sale of investments |
| (13,844 | ) | |||||
Loss on sale of assets |
| 31 | ||||||
Gain on redemption of notes payable |
(198 | ) | (4,397 | ) | ||||
Write off and amortization of debt issue costs |
904 | 2,220 | ||||||
Amortization of debt securities bond
premium/discount |
132 | 548 | ||||||
Changes in operating assets and liabilities |
(17,491 | ) | (2,555 | ) | ||||
Net cash (used in) provided by operating
activities |
(9,839 | ) | 23,842 | |||||
Cash flows from investing activities: |
||||||||
Purchase of property and equipment |
(11,564 | ) | (3,678 | ) | ||||
Proceeds from sale of equity investment |
| 20,209 | ||||||
Purchase of product rights |
(17,500 | ) | (35,000 | ) | ||||
Proceeds from sale of marketable securities |
110,850 | 67,925 | ||||||
Purchase of marketable securities |
(164,488 | ) | (363,308 | ) | ||||
Maturities of marketable securities |
103,492 | 246,550 | ||||||
Net cash provided by (used in) investing
activities |
20,790 | (67,302 | ) | |||||
Cash flows from financing activities: |
||||||||
Proceeds from exercise of common stock options |
339 | 106 | ||||||
Proceeds from employee stock purchase plan |
226 | | ||||||
Redemption of notes payable |
(15,723 | ) | (129,380 | ) | ||||
Proceeds from issuance of notes payable |
| 275,000 | ||||||
Cash payment for debt issuance costs |
| (7,655 | ) | |||||
Net cash (used in) provided by financing
activities |
(15,158 | ) | 138,071 | |||||
Net (decrease) increase in cash and cash equivalents |
(4,207 | ) | 94,611 | |||||
Cash and cash equivalents at beginning of period |
28,431 | 76,497 | ||||||
Cash and cash equivalents at end of period |
$ | 24,224 | $ | 171,108 | ||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
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. and its subsidiaries (Enzon or the Company) in
accordance with United States generally accepted accounting principles (GAAP) for interim financial
information and Rule 10-01 of the U.S. Securities and Exchange Commission (SEC) Regulation S-X.
Accordingly, these financial statements do not include all of the information and footnotes
required for complete annual financial statements. The preparation of financial statements in
conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date
of the financial statements and the reported amounts of revenues and expenses during the reporting
period. 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
amounts have been 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 Companys Annual Report on Form 10-K for the year
ended December 31, 2006.
(2) Marketable Securities
The Company classifies its investments in marketable equity securities and debt securities,
including auction rate securities, as available-for-sale. The Company classifies those investments
with maturities of one year or less as current assets and investments in debt securities with
maturities greater than one year and marketable equity securities as noncurrent assets when it has
the intent and ability to hold such securities for at least one year. Debt and marketable equity
securities are carried at fair value, with the unrealized gains and losses (which are deemed to be
temporary), net of related tax effect, when appropriate, included in the determination of other
comprehensive income (loss) and reported in stockholders deficit. The fair value of all
securities is determined by quoted market prices.
The cost of the debt securities is adjusted for amortization of premiums and accretion of
discounts to maturity. The amortization and accretion, along with realized gains and losses and
interest income, are included in investment income, net. The cost of securities for gain or loss
determination is based on the specific identification method.
The Company holds auction rate securities for which interest or dividend rates are generally
reset for periods of up to 90 days. The auction rate securities outstanding at June 30, 2007 and
December 31, 2006 were investments in state government bonds and corporate securities.
Other securities include investments of participants in the Companys Executive Deferred
Compensation Plan which are predominantly mutual fund shares totaling $2.0 million as of June 30,
2007 and $1.8 million as of December 31, 2006. In addition,
other securities include $0.4 million of corporate equity securities
as of June 30, 2007. As of December 31, 2006, the investments of the deferred compensation
plan also included $0.6 million of securities of
government-sponsored enterprises (GSE). In addition, the assets of the deferred
compensation plan also include cash ($0.7 million and $0.3
million at June 30, 2007 and December 31, 2006, respectively). There is a non-current liability
that offsets the aggregate deferred compensation plan assets.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The amortized cost, gross unrealized holding gains or losses, and fair value of the Companys
available-for-sale securities by major security type at June 30, 2007 were as follows (in
thousands):
Gross | Gross | |||||||||||||||
Amortized | Unrealized | Unrealized | ||||||||||||||
Cost | Holding Gains | Holding Losses | Fair Value* | |||||||||||||
U.S. Government and GSE debt |
$ | 19,502 | $ | | $ | (111 | ) | $ | 19,391 | |||||||
U.S. corporate debt |
111,263 | | (195 | ) | 111,068 | |||||||||||
Auction rate securities |
30,035 | | | 30,035 | ||||||||||||
Other |
1,962 | 401 | | 2,363 | ||||||||||||
$ | 162,762 | $ | 401 | $ | (306 | ) | $ | 162,857 | ||||||||
* | $127,815 is included in short-term investments and $35,042 is included in marketable securities. |
The amortized cost, gross unrealized holding gains or losses, and fair value of the Companys
available-for-sale securities by major security type at December 31, 2006 were as follows (in
thousands):
Gross | Gross | |||||||||||||||
Amortized | Unrealized | Unrealized | ||||||||||||||
Cost | Holding Gains | Holding Losses | Fair Value* | |||||||||||||
U.S. Government and GSE debt |
$ | 36,003 | $ | | $ | (260 | ) | $ | 35,743 | |||||||
U.S. corporate debt |
133,904 | 7 | (230 | ) | 133,681 | |||||||||||
Auction rate securities |
40,350 | | | 40,350 | ||||||||||||
Other |
2,374 | 26 | | 2,400 | ||||||||||||
$ | 212,631 | $ | 33 | $ | (490 | ) | $ | 212,174 | ||||||||
* $145,113 is included in short-term investments and $67,061 is included in marketable
securities.
Maturities of marketable debt securities, excluding securities related to the Companys
Executive Deferred Compensation Plan, at June 30, 2007 were as follows (in thousands):
Twelve-Month | |||||||||
Periods Ending | |||||||||
June 30, | Amortized Cost | Fair Value | |||||||
2008 |
$ | 127,735 | $ | 127,467 | |||||
2009 |
7,030 | 6,992 | |||||||
Maturities beyond five years |
26,035 | 26,035 | |||||||
$ | 160,800 | $ | 160,494 | ||||||
Impairment assessments are made at the individual security level each reporting period. When
the fair value of an investment is less than its cost at the balance sheet date, a determination is
made as to whether the impairment is other than temporary and, if it is other than temporary, an
impairment loss is recognized in earnings equal to the difference between the investments cost and
fair value at such date. The Company has determined that there were no other-than-temporary
declines in the fair values of its marketable securities and short-term investments as of June 30,
2007.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The following table shows the gross unrealized losses and fair values of the Companys
available-for-sale securities (both short-term and long-term) aggregated by investment category and
length of time that individual securities have been in a continuous loss position at June 30, 2007
(in thousands):
Less Than 12 Months | 12 Months or Greater | |||||||||||||||
Fair | Unrealized | Fair | Unrealized | |||||||||||||
Value | Loss | Value | Loss | |||||||||||||
U.S. Government and GSE debt (1) |
$ | 2,995 | $ | (5 | ) | $ | 14,397 | $ | (106 | ) | ||||||
U.S. corporate debt (2) |
109,381 | (195 | ) | | | |||||||||||
Total |
$ | 112,376 | $ | (200 | ) | $ | 14,397 | $ | (106 | ) | ||||||
(1) | The unrealized losses of $0.1 million in the U.S. Government and GSE mortgage-backed securities were attributable to increases in interest rates. These holdings do not permit the issuer to settle the securities at a price less than the amortized cost. Further, because the declines in market value are due to increases in interest rates and not the credit quality of the issuer, and the Company has the ability and the intent to hold these investments until recovery of the cost, the Company does not consider its investments in U.S. Government and GSE debt to be other-than-temporarily impaired at June 30, 2007. | |
(2) | The unrealized losses of $0.2 million on the U.S. corporate debt were attributable to increases in interest rates, as well as bond pricing. The Company invests in bonds that are rated A1 or better, as dictated by its investment policy. Since the changes in the market value of these investments are due to changes in interest rates and not the credit quality of the issuer, and the Company has the ability and intent to hold these investments until recovery of the cost, the Company does not consider its investments in U.S. corporate debt to be other-than-temporarily impaired at June 30, 2007. |
(3) Comprehensive (Loss) Income
The following table reconciles net (loss) income to comprehensive (loss) income (in
thousands):
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2007 | 2006 | 2007 | 2006 | |||||||||||||
Net (loss) income |
$ | (3,044 | ) | $ | 10,987 | $ | (4,897 | ) | $ | 32,695 | ||||||
Other comprehensive income: |
||||||||||||||||
Unrealized gain on securities
that arose during the period |
227 | 128 | 668 | 14,009 | ||||||||||||
Reclassification adjustment
for gain included in net
income(1) |
| | | (13,844 | ) | |||||||||||
Total other comprehensive income |
227 | 128 | 668 | 165 | ||||||||||||
Comprehensive (loss) income |
$ | (2,817 | ) | $ | 11,115 | $ | (4,229 | ) | $ | 32,860 | ||||||
(1) Information has not been tax-effected due to an estimated annual effective
tax rate of zero.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(4) Earnings Per Common Share
Basic (loss) earnings per common share is computed by dividing the net (loss) income available
to common stockholders by the weighted average number of shares of common stock outstanding during
the period. Restricted stock awards and restricted stock units (collectively, nonvested shares)
are not considered to be outstanding shares until the service vesting period has been completed.
For purposes of calculating diluted (loss) earnings per common share, the denominator includes both
the weighted average number of shares of common stock outstanding and the number of common stock
equivalents if the inclusion of such common stock equivalents is dilutive. Dilutive common stock
equivalents potentially include non-qualified stock options, nonvested shares, shares issuable
under the employee stock purchase plan (ESPP) and the number of shares issuable upon conversion of
the Companys convertible subordinated notes payable and/or convertible senior notes payable. In
the case of notes payable, the diluted earnings per share calculation is further affected by an
add-back of interest to the numerator under the assumption that the interest would not have been
incurred if the notes payable were converted into common stock.
The dilutive effect of stock options and nonvested shares takes into account a number of
treasury shares calculated using assumed proceeds, which includes share-based compensation costs to
be attributed to future service and not yet recognized and, in the case of stock options, the cash
paid by the holders to exercise plus the excess, if any, of tax benefits that would be credited to
additional paid-in capital.
For the three-month periods ended June 30, 2007 and 2006, the Company determined that all
potentially dilutive common stock equivalents (30.7 million and 18.1 million shares, respectively)
were anti-dilutive. Similarly, for the six-month periods ended June 30, 2007 and 2006, all
potentially dilutive common stock equivalents (30.7 million and 11.8 million, respectively), were
antidilutive. Consequently, reported diluted (loss) earnings per common share is the same as the
basic (loss) earnings per common share amount in each of these periods. Furthermore, for the three
months and six months ended June 30, 2007, the Company reported a net loss thus causing potentially
dilutive common stock equivalents to be antidilutive.
(5) Share-Based Compensation
The Company accounts for its share-based compensation plans, including stock options,
nonvested share awards and ESPP, according to the provisions of Financial Accounting Standards
Board (FASB) Statement of Financial Accounting Standards No. 123 (revised), Share-Based Payment
(SFAS No. 123R).
Stock Option and Nonvested Share Awards
During the three months ended June 30, 2007 and 2006, the Company recognized share-based
compensation expense of $1.5 million and $1.6 million, respectively, relating to stock option and
nonvested share awards. During the six-month periods ended June 30, 2007 and 2006, the Company
recognized share-based compensation expense of $3.6 million and $2.6 million, respectively, for
these plans. Activity in options and nonvested shares during the six-months ended June 30, 2007
and related balances outstanding as of that date are reflected below (in thousands). The weighted
average grant price of the options granted was $8.56 per share and fair values ranged from $3.30 to
$3.61 per share. The fair value in total during the six months ended June 30, 2007 was $7.3
million. The nonvested shares granted during the six months had a weighted average grant-date fair
value of $8.53 per share. The Company uses historical data to estimate forfeiture rates.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Nonvested | ||||||||
Options | Shares | |||||||
Outstanding at December 31, 2006 |
6,708 | 1,458 | ||||||
Granted |
2,020 | 380 | ||||||
Exercised and vested |
(74 | ) | (8 | ) | ||||
Expired and forfeited |
(141 | ) | (47 | ) | ||||
Outstanding at June 30, 2007 |
8,513 | 1,783 | ||||||
Options vested and expected to vest at June 30, 2007 |
7,484 | |||||||
Options exercisable at June 30, 2007 |
5,143 | |||||||
As of June 30, 2007, there was $8.1 million of total unrecognized compensation cost related to
unvested options that the Company expects to recognize over a weighted-average period of 26 months
and $11.5 million of total unrecognized compensation cost related to nonvested shares to be
recognized over a weighted-average period of 36 months.
Employee Stock Purchase Plan
In January 2007, the Board of Directors adopted the 2007 ESPP which was approved by the
stockholders in May 2007. An initial one million shares were reserved for issuance under the plan.
All benefit-eligible employees of the Company may participate in the ESPP other than those who
own shares or hold options or nonvested shares representing a combined 5% or more of the voting
power of the Companys outstanding stock. The ESPP permits eligible employees to purchase common
stock through payroll deductions which many not exceed 15% of the employees compensation, as
defined, at a price equal to 85% of the fair market value of the shares at the beginning of the
offering period (grant date) or at the end of the offering period (purchase date), whichever is
lower. There are two six-month offering periods in each fiscal year, beginning April 1 and October
1. The ESPP is intended to qualify under section 423 of the Internal Revenue Code. Individual
participant purchases within a given calendar year are limited to $25,000 ($21,250 based on the 15%
discount) and no more than 2,500 shares on any single purchase date. Unless terminated sooner, the
ESPP will terminate on January 25, 2017.
The fair value of shares to be issued under the ESPP is estimated at the grant date and is
comprised of two components: the 15% discount to fair value of the shares at grant date and the
value of the option granted to participants pursuant to which they may purchase shares at the lower
of either the grant date or the purchase date fair value. The option component is valued using the
Black-Scholes option pricing model. For the first offering period of the new plan beginning April
1, 2007, the following initial assumptions were used to value the option component: 4.5% risk-free
interest rate, 20% expected volatility, 0.5 years expected life and no dividend yield. Increases
in individual withholding rates within the offering period could have the effect of establishing a
new measurement date such that the weighted-average assumptions used for the entire offering period
ending September 30, 2007 may vary from those indicated above. For the quarter and six months
ended June 30, 2007, compensation expense recognized for the ESPP was $0.1 million which was
recorded in the same expense categories in the interim consolidated statement of operations as the
underlying employee compensation. Amounts withheld from participants are classified as cash from
financing activities in the cash flow statement and as a liability in the balance sheet until such
time as shares are purchased. There were no stock purchases under the ESPP during the three or six
months ended June 30, 2007.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(6) Inventories
As of June 30, 2007 and December 31, 2006 inventories consisted of the following (in
thousands):
December 31, | ||||||||
June 30, 2007 | 2006 | |||||||
Raw materials |
$ | 7,945 | $ | 7,321 | ||||
Work in process |
8,096 | 4,444 | ||||||
Finished goods |
3,374 | 5,853 | ||||||
$ | 19,415 | $ | 17,618 | |||||
(7) Intangible Assets
As of June 30, 2007 and December 31, 2006 intangible assets consisted of the following (in
thousands):
Weighted | ||||||||||||
Average | ||||||||||||
December 31, | Remaining | |||||||||||
June 30, 2007 | 2006 | Useful Lives | ||||||||||
Product acquisition costs |
$ | 78,694 | $ | 78,694 | 7 years | |||||||
Product patented technology |
6,000 | 6,000 | 8 years | |||||||||
Manufacturing patent |
9,000 | 9,000 | 1 years | |||||||||
Patent |
1,875 | 1,875 | * | |||||||||
95,569 | 95,569 | |||||||||||
Less: Accumulated
amortization |
22,260 | 17,059 | ||||||||||
$ | 73,309 | $ | 78,510 | |||||||||
* | fully amortized |
In December 2006, the Company entered into supply and license agreements with Ovation
Pharmaceuticals, Inc. (Ovation) related to the active ingredient used in the production of
Oncaspar. The agreement called for the Company to make a $20.0 million nonrefundable payment in
February 2007 for a non-exclusive, fully paid, perpetual, worldwide license of the cell line from
which the active ingredient is derived, as well as to related data and know-how. Of the $20.0
million, $2.5 million was for an initial supply of the ingredient by Ovation to the Company. The
$17.5 million portion of the payment attributable to the license was reflected as a current
liability and as an intangible asset as of December 31, 2006. The $17.5 million intangible asset
portion of the payment to Ovation is being amortized on a straight-line basis over its estimated
economic life, which is coincident with the remaining term of the Companys royalty obligations for
Oncaspar through June 30, 2014.
For the three months and six months ended June 30, 2007, amortization charged to operations
relating to intangible assets totaled $2.6 million and $5.2 million, respectively, of which $2.4
million and $4.8 million, respectively, was classified in cost of product sales and contract
manufacturing. For the three months and six months ended June 30, 2006, amortization expense was
$2.0 million and $4.0 million, respectively, of which $1.8 million and $3.7 million, respectively,
was charged to cost of product sales and contract manufacturing.
10
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(8) Notes Payable
The table below reflects the composition of the notes payable balances as of June 30, 2007 and
December 31, 2006 (in thousands):
December 31, | ||||||||
June 30, 2007 | 2006 | |||||||
4.5% Convertible Subordinated Notes due
July 1, 2008 |
$ | 106,721 | $ | 122,642 | ||||
4% Convertible Senior Notes due June 1,
2013 |
275,000 | 275,000 | ||||||
$ | 381,721 | $ | 397,642 | |||||
The 4.5% notes mature on July 1, 2008 and are convertible, at the option of the holders, into
common stock of the Company at a conversion price of $70.98 per share at any time on or before July
1, 2008. The 4.5% notes are subordinated to all existing and future senior indebtedness. Upon
occurrence of a fundamental change, as defined in the indenture governing the notes, holders of
the notes may require the Company to redeem the notes at a price equal to 100% of the principal
amount plus accrued and unpaid interest. The Company may redeem any or all of the 4.5% notes at
specified redemption prices, plus accrued and unpaid interest to the day preceding the redemption
date.
The 4% notes mature on June 1, 2013, unless earlier redeemed, repurchased or converted, at the
option of the holders, into the Companys common stock at an initial conversion price of $9.55 per
share. The 4% notes are senior unsecured obligations and rank equal to other senior unsecured debt
of the Company and all future senior unsecured debt of the Company.
At any time on or after June 1, 2009, if the closing price of the Companys common stock for
at least 20 trading days in the 30-consecutive-trading-day period ending on the date one day prior
to the date of a notice of redemption is greater than 140% of the applicable conversion price on
the date of such notice, the Company, at its option, may redeem the 4% notes in whole or in part,
at a redemption price in cash equal to 100% of the principal amount of the 4% notes to be redeemed,
plus accrued and unpaid interest, if any, to the redemption date. The 4% notes are not redeemable
prior to June 1, 2009. Upon occurrence of a fundamental change, as defined in the indenture
governing the 4% notes, holders of the notes may require the Company to redeem the notes at a price
equal to 100% of the principal amount plus accrued and unpaid interest or, in certain cases, to
convert the notes at an increased conversion rate based on the price paid per share of the
Companys common stock in the transaction constituting the fundamental change.
In connection with the Companys second-quarter 2006 issuance of $275.0 million of the 4%
notes, the Company entered into a registration rights agreement whereby it agreed to file a shelf
registration statement with the SEC to permit the registered resale of the 4% notes and the common
stock issuable upon conversion of the notes. The shelf registration was filed in a timely manner
on October 2, 2006 and was declared effective by the SEC on November 3, 2006. Failure to maintain
the effectiveness of the registration statement for a period of two years beginning November 3,
2006 would result in additional interest of up to $1.9 million being payable on the 4% notes as of
June 30, 2007.
Interest on the 4.5% notes is payable January 1 and July 1 of each year. Accrued interest on
the 4.5% notes was $2.4 million as of June 30, 2007 and $2.7 million as of December 31, 2006.
Interest on the 4% notes is payable on June 1 and December 1 of each year. As of June 30, 2007
accrued interest on the 4% notes amounted to $0.9 million, unchanged from December 31, 2006.
The Company evaluated the accounting for the conversion features in accordance with Emerging
Issues Task Force Issue (EITF) No. 00-19, Accounting for Derivative Financial Instruments Indexed
to and Potentially Settled in, a Companys Own Stock, and related issues, at the date of issuance
of the 4% and 4.5% Convertible Notes and determined that the conversion features should be
classified as equity, and therefore they do not need to be accounted for separately from the
respective convertible notes. The Company updates its
11
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
analyses of the accounting for the conversion features on a quarterly basis and more frequently if
circumstances warrant. If a conversion feature is required to be bifurcated in the future, changes
in the fair value of the conversion feature would be charged or credited to interest expense in
each period.
Effective January 1, 2007, the Company evaluates the accounting for the 4% convertible notes
registration rights in accordance with FASB Staff Position (FSP) EITF No. 00-19-2, Accounting for
Registration Payment Arrangements, which specifies that registration payment arrangements should
play no part in determining the initial classification and subsequent accounting for the securities
they related to. The Staff Position requires the contingent obligation in a registration
payment arrangement to be separately analyzed under FASB Statement No. 5, Accounting for
Contingencies and FASB Interpretation No. 14, Reasonable Estimation of the Amount of a Loss. If
payment in a registration payment arrangement is probable and can be reasonably estimated, a
liability should be recorded. Based on the Companys evaluation, no liability relating to the
convertible notes was required to be recorded as of January 1, 2007 or June 30, 2007.
(9) Restructuring
During the first quarter of 2007, the Company announced plans to consolidate manufacturing
operations in its Indianapolis, Indiana location. This action was taken as part of the Companys
continued efforts to streamline operations.
As a result, all operations at the Companys South Plainfield, New Jersey facility are
expected to be transferred in 2008, resulting in the incurrence of certain restructuring and exit
costs. Among these costs will be employee severance and related benefits for affected employees in
an estimated range of approximately $3.5 million to $4.0 million all of which relate to the
Products segment. These amounts will be paid in 2008 upon the successful transfer of production to
Indianapolis and satisfactory performance by the affected employees during the transition period.
The Company has recognized severance costs of $0.7 million in the second quarter of 2007 and $1.3
million since inception of the plan. In the three months ended June 30, 2007, $1.9 million, being
the cost of validation batches for both Oncaspar and Adagen, were expensed and included in cost of
product sales. Other costs are expected to be incurred relating to relocation of goods and
equipment including additional validation of production processes transferred to Indianapolis, and
will be recognized as incurred. In the aggregate, including employee and validation costs, the
Company anticipates incurring costs in connection with this restructuring plan in the range of $8.0
million to $10.0 million, a portion of which will be classified as cost of product sales.
In addition, the Company may experience costs associated with lease termination or sublease of
the South Plainfield facility of as much as $8.0 million. Such costs would be incurred and
recognized when the Company ceases use of the property in 2008. However, the Company does not know
at this time what the final use or disposition of the leased South Plainfield facility will be.
There is also a possibility that non-cash charges could be incurred related to asset impairments or
acceleration of depreciation, if future triggering events occur. At June 30, 2007, the Companys
analysis of the future net undiscounted cash flows for the South Plainfield facility assets did not
indicate an impairment.
(10) Supplemental Cash Flow Information
The Company considers all highly liquid investment securities with original maturities of
three months or less to be cash equivalents. For each of the six-month periods ended June 30, 2007
and 2006, there were payments of interest on the Companys notes payable of $8.5 million and $11.2
million, respectively. Income tax payments for the six months ended June 30, 2007 and 2006, were
$0.5 million and $0.1 million, respectively.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(11) Income Taxes
During the three months and six months ended June 30, 2007, the Company recorded a tax expense
of approximately $0.3 million and $0.1 million, respectively, which represents state and Canadian
tax liabilities and includes an adjustment to taxes payable. During the three months and six
months ended June 30, 2006, the Company recorded a tax expense of approximately $0.3 million and
$0.4 million, respectively, which represents state and Canadian taxes payable. No federal income
tax provision was recorded for these periods as the estimated annual effective tax rate is zero due
to the Companys ability to utilize its federal net operating loss carry forwards to eliminate its
projected taxable income. As of June 30, 2007, the Company continues to provide a valuation
allowance against its net deferred tax assets since the Company believes it is more likely than not
its deferred tax assets will not be realized.
In accordance with FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes
(FIN 48), tax benefits of uncertain tax positions are recognized only if it is more likely than not
that the Company will be able to sustain a position taken on an income tax return. Upon adoption
of FIN 48, as amended, as of January 1, 2007, the Company had no tax positions relating to open
income tax returns that were considered to be uncertain. Accordingly, the Company had no liability
for such uncertain positions nor did it establish such a liability upon adoption of the
interpretation nor during the six months ended June 30, 2007.
The Company files income tax returns in the U.S. federal jurisdiction, various state
jurisdictions and Canada. The Company is currently not under examination by the U.S. Internal
Revenue Service, however, the tax years 2004 through 2006 remain open to examination.
State income tax returns for the states of New Jersey and Indiana are generally subject to
examination for a period of 3-4 years after filing of the respective returns. The Companys state
income tax returns are currently not under examination by either New Jersey or Indiana.
Income tax returns for Canada are generally subject to examination for a period of 3-5 years
after filing of the respective return. The Companys income tax returns are currently not under
examination by Revenue Canada.
Interest and penalties, if any, related to unrecognized tax benefits, would be recognized as
income tax expense.
(12) Segment Information
The Company operates in the following business and reportable segments:
Products - Currently, the Company has developed or acquired four therapeutic, FDA-approved
products focused primarily in oncology and adjacent diseases. The Company currently markets its
products through its specialized U.S. sales forces that call upon specialists in oncology,
hematology and other critical care disciplines. The Companys four proprietary marketed brands are
Oncaspar, Abelcet, Adagen and DepoCyt.
Royalties The Company derives licensing income from royalties received on the manufacture
and sale of products that utilize its proprietary technology. Royalties are primarily derived from
sales by Schering-Plough of PEG-INTRON. In addition to royalties from PEG-INTRON, the Company
receives royalty revenues on Pegasys and Macugen through an agreement with Nektar Therapeutics,
Inc. (Nektar) under which the Company shares in Nektars royalties on sales of these products.
Contract Manufacturing - The Company provides contract manufacturing services for third
parties primarily MYOCET and Abelcet for export, each for Cephalon, Inc., and the injectable
multivitamin, MVI, for Hospira, Inc.
13
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Profit (loss) for the Companys segments is measured based on operating results, excluding
investment income, interest expense and income taxes. The Companys research and development
expense is considered a corporate expense until a product candidate enters Phase III clinical
trials at which time related costs would be chargeable to one of the Companys operating segments.
The Company does not identify or allocate property and equipment by operating segment, and does not
allocate depreciation to the operating segments. Operating segments do not have intersegment
revenue, and accordingly, there is none to be reported.
The following tables present segment revenues and profitability information for the
three-month and six-month periods ended June 30, 2007 and 2006 (in thousands):
Three months ended June 30, | ||||||||||||||||||||||||
Contract | ||||||||||||||||||||||||
Segment | Products | Royalties | Manufacturing | Corporate(1) | Consolidated | |||||||||||||||||||
Revenues |
2007 | $ | 25,019 | $ | 18,290 | $ | 5,903 | $ | | $ | 49,212 | |||||||||||||
2006 | $ | 24,537 | $ | 17,936 | $ | 5,131 | $ | | $ | 47,604 | ||||||||||||||
Profit
(Loss)(2) |
2007 | $ | 636 | $ | 18,290 | $ | 1,813 | $ | (23,522 | ) | $ | (2,783 | ) | |||||||||||
2006 | $ | 6,389 | $ | 17,936 | $ | 1,995 | $ | (15,045 | ) | $ | 11,275 |
Six months ended June 30, | ||||||||||||||||||||||||
Contract | ||||||||||||||||||||||||
Segment | Products | Royalties | Manufacturing | Corporate(1) | Consolidated | |||||||||||||||||||
Revenues |
2007 | $ | 47,668 | $ | 34,634 | $ | 8,398 | $ | | $ | 90,700 | |||||||||||||
2006 | $ | 48,812 | $ | 35,184 | $ | 8,337 | $ | | $ | 92,333 | ||||||||||||||
Profit
(Loss)(2) |
2007 | $ | 3,002 | $ | 34,634 | $ | 1,854 | $ | (44,319 | ) | $ | (4,829 | ) | |||||||||||
2006 | $ | 13,009 | $ | 35,184 | $ | 2,767 | $ | (17,841 | ) | $ | 33,119 |
(1) | Corporate expenses include operating income (loss) components that are not directly attributable to an operating segment, including general and administrative expenses, treasury activities and exploratory, preclinical and clinical research and development expenses not specifically identifiable with existing marketed products or product candidates that have not entered Phase III clinical trials. | |
(2) | Starting in the fourth quarter of 2006, the Company began evaluating the performance of the Products segment with the inclusion of research and development costs related to marketed products and new indications for those products. Segment profit for prior periods reflects reclassifications for comparability. |
Following is a reconciliation of segment profit to consolidated income (loss) before income
tax provision (in thousands):
Three Months Ended June 30 | Six Months Ended June 30, | |||||||||||||||
2007 | 2006 | 2007 | 2006 | |||||||||||||
Segment profit |
$ | 20,739 | $ | 26,320 | $ | 39,490 | $ | 50,960 | ||||||||
Unallocated operating expense |
21,724 | 15,966 | 40,635 | 29,456 | ||||||||||||
Operating (loss) income |
(985 | ) | 10,354 | (1,145 | ) | 21,504 | ||||||||||
Other corporate (expense) and income
|
(1,798 | ) | 921 | (3,684 | ) | 11,615 | ||||||||||
(Loss) income before income
tax provision |
$ | (2,783 | ) | $ | 11,275 | $ | (4,829 | ) | $ | 33,119 | ||||||
14
Table of Contents
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations.
Overview
We are a biopharmaceutical company dedicated to the development, manufacturing and
commercialization of therapeutics to treat patients with cancer and other life-threatening
conditions. We operate in three business segments: Products, Royalties and Contract
Manufacturing. Our hospital and oncology sales forces market Oncaspar, Abelcet, Adagen, and
DepoCyt in the United States. In addition, we receive royalties, primarily on sales of PEG-INTRON,
marketed by Schering-Plough Corporation. Royalties are derived through the application of our
proprietary PEGylation technology to other companies products. PEGylation is a proven means of
enabling or enhancing the performance of pharmaceuticals with delivery limitations through the
chemical attachment of polyethylene glycol or PEG. Our product-driven strategy includes an
extensive drug development program that leverages our proprietary technologies, including a
Customized Linker TechnologyTM PEGylation platform that utilizes customized linkers
designed to release compounds at a controlled rate. We complement our internal research and
development efforts with strategic initiatives, such as partnerships designed to broaden our
revenue base or provide access to promising new technologies or product development opportunities.
We also engage in contract manufacturing opportunities with third parties to improve our
efficiency.
Results of Operations
Three Month and Six Month Periods Ended June 30, 2007 and 2006
Overview
Several factors contributed to our reported net loss in the three-month and six-month periods
ended June 30, 2006. While total revenues remained relatively stable period over period, spending
on research and development increased significantly, as planned and previously disclosed. Also,
our cost of product sales and manufacturing rose significantly due in part to the expensing of
validation batches as a result of the initiation of the transfer of production from our South
Plainfield, New Jersey manufacturing facility to our plant in Indianapolis, Indiana.
Restructuring charges in 2007 related to the relocation from South Plainfield and certain
non-operating gains in 2006 in connection with the sale of an investment and our debt refinancing
also affected period-to-period comparisons. Each of these events and transactions is discussed
more fully in the analysis that follows.
Following is a reconciliation of segment profitability to consolidated income before income
tax (millions of dollars). The percentage changes below and throughout this Managements
Discussion and Analysis are based on thousands of dollars and not the rounded millions of dollars
reflected throughout this section.
Three Months Ended | Six Months Ended | |||||||||||||||||||||||
June | % | June | June | % | June | |||||||||||||||||||
2007 | Change | 2006 | 2007 | Change | 2006 | |||||||||||||||||||
Products Segment profit |
$ | 0.6 | (90 | ) | $ | 6.4 | $ | 3.0 | (77 | ) | $ | 13.0 | ||||||||||||
Royalty Segment profit |
18.3 | 2 | 18.0 | 34.6 | 2 | 35.2 | ||||||||||||||||||
Contract Manufacturing
Segment profit |
1.9 | (9 | ) | 2.0 | 1.9 | (33 | ) | 2.8 | ||||||||||||||||
Corporate and other
expenses* |
(23.5 | ) | 56 | (15.1 | ) | (44.3 | ) | 148 | (17.9 | ) | ||||||||||||||
(Loss) income before income
tax provision |
$ | (2.7 | ) | n.m. | $ | 11.3 | $ | (4.8 | ) | n.m. | $ | 33.1 | ||||||||||||
* | We do not allocate certain corporate income and expenses not directly identifiable with the respective segments, including general and administrative expenses, exploratory and preclinical research and development expenses, depreciation, investment income, interest expense and income taxes. Research and development expense is considered a corporate expense unless it relates to an existing marketed product or a product candidate enters Phase III clinical trials at which time related costs would be chargeable to one of our operating segments. | |
n.m. not meaningful |
15
Table of Contents
Products Segment
Products Segment profitability (millions of dollars):
Three Months Ended | Six Months Ended | |||||||||||||||||||||||
June | % | June | June | % | June | |||||||||||||||||||
2007 | Change | 2006 | 2007 | Change | 2006 | |||||||||||||||||||
Revenues |
$ | 25.0 | 2 | $ | 24.5 | $ | 47.7 | (2 | ) | $ | 48.8 | |||||||||||||
Cost of sales |
12.2 | 32 | 9.2 | 21.2 | 22 | 17.3 | ||||||||||||||||||
Research and
development |
3.8 | 267 | 1.0 | 6.2 | 169 | 2.3 | ||||||||||||||||||
Selling and marketing |
7.5 | (3 | ) | 7.7 | 15.6 | (2 | ) | 15.8 | ||||||||||||||||
Amortization of
intangibles |
0.2 | | 0.2 | 0.4 | | 0.4 | ||||||||||||||||||
Restructuring |
0.7 | n.m. | | 1.3 | n.m. | | ||||||||||||||||||
Segment profit |
$ | 0.6 | (90 | ) | $ | 6.4 | $ | 3.0 | (77 | ) | $ | 13.0 | ||||||||||||
n.m. not meaningful |
Revenues
Sales performance of individual products is provided below (millions of dollars):
Three Months Ended | Six Months Ended | |||||||||||||||||||||||
June | % | June | June | % | June | |||||||||||||||||||
Product | 2007 | Change | 2006 | 2007 | Change | 2006 | ||||||||||||||||||
Oncaspar |
$ | 9.6 | 28 | $ | 7.5 | $ | 17.1 | 23 | $ | 13.9 | ||||||||||||||
DepoCyt |
2.1 | 7 | 1.9 | 4.5 | 11 | 4.0 | ||||||||||||||||||
Abelcet |
6.7 | (28 | ) | 9.4 | 14.4 | (27 | ) | 19.9 | ||||||||||||||||
Adagen |
6.6 | 16 | 5.7 | 11.7 | 6 | 11.0 | ||||||||||||||||||
Totals |
$ | 25.0 | 2 | $ | 24.5 | $ | 47.7 | (2 | ) | $ | 48.8 | |||||||||||||
Growth in sales of Oncaspar, DepoCyt and Adagen more than offset the continuing decline in
sales of Abelcet during the second quarter of 2007 and largely offset the Abelcet declines over the
six-month period ended June 30, 2007, when compared to the prior year period. For the three months
ended June 30, 2007, net product sales increased to $25.0 million or 2% over the same period of
2006 and, for the six-month period ended June 30, 2007, net product sales of $47.7 million were 2%
lower than the net product sales recorded in the first six months of 2006.
The 23% increase in revenue for our oncology product, Oncaspar, during the six months ended
June 30, 2007, as compared to the six months ended June 30, 2006, was driven in part by volume
growth of 10% and the impact of an April 1, 2007 price increase. The July 2006 approval by the
U.S. Food and Drug Administration (FDA) of Oncaspar for the first-line treatment of patients with
acute lymphoblastic leukemia has contributed to this trend in demand. Sales of DepoCyt, for
treatment of lymphomatous meningitis, and Adagen, for treatment of severe combined
immuno-deficiency disease, tend to fluctuate from quarter to quarter
due to their small patient bases. The April 1, 2007 price increase favorably affected these two
products as well. In April 2007, the FDA granted full approval of
DepoCyt. Originally, DepoCyt was approved under the FDAs Sub Part H
regulation. Abelcet sales volumes in the U.S. and Canada, on the other hand, continue to
decline due to continued competition from newer generation antifungal products coupled with some
contraction of the overall intravenous antifungal market. Abelcet declined 28% and 27% for the
three-month and six-month periods, respectively, ended June 30, 2007 when compared to the same
periods in the preceding year. We anticipate continued Abelcet competition.
Cost of sales
In the three months ended June 30, 2007, cost of products sold of $12.2 million as a
percentage of sales rose to 49% compared to 38% ($9.2 million) for the year-earlier period. This
contributed to a corresponding year-to-date rise in cost of sales as a percentage of sales from 36%
of sales to 45%. The initiation of the transfer of production of Oncaspar and Adagen from our
South Plainfield facility to Indianapolis involves the production of a number of test lots in order
to validate the new production processes and assure the continued quality and stability of product.
These test production batches totaling $1.9 million in the three months ended June 30,
16
Table of Contents
2007, are unsaleable and were expensed, causing part of the increase in second-quarter cost of
sales. Excluding the additional $1.9 million associated with these validation batches, cost of
products sold as a percentage of sales would have been 41% (compared to 38% of the year earlier
period) and 41% (compared to 36% of the year earlier period) for the three months and six months
ended June 30, 2007, respectively. In addition, substantially higher supplier costs of materials
for Adagen, negative production variances in the second quarter for Abelcet and the amortization of
the Oncaspar-related intangible asset acquired in December 2006 to secure the supply of
L-asparaginase, all contributed to higher cost of sales.
Research and development
Research and development spending on marketed products, primarily Oncaspar and Adagen,
increased from $1.0 million in the second quarter of 2006 to $3.8 million in the second quarter of
2007 and from $2.3 million to $6.2 million for the corresponding six-month periods. The rise in
product-related research and development expense was due to ongoing formulation enhancement of
Oncaspar and Adagen as well as Oncaspar life-cycle management.
Selling and marketing
Overall, spending on selling and marketing in 2007 decreased slightly from 2006. This
decrease was due to comparatively lower marketing costs in 2007 as a result of selective
investments on our marketed products.
Amortization of acquired intangible assets
Amortization expense of $0.2 million for the three months ended June 30, 2007, and $0.4
million for the six months ended June 30, 2007 was unchanged from the corresponding periods of
2006. Amortization of intangible assets has been provided over their remaining estimated lives
ranging from 1-14 years on a straight-line basis.
Restructuring
During the first quarter of 2007, we announced plans to consolidate manufacturing operations
in our Indianapolis, Indiana location. This action was taken as part of our continued efforts to
streamline operations.
As a result, all operations at our South Plainfield, New Jersey facility are expected to be
transferred in 2008, resulting in the incurrence of certain restructuring and exit costs. Among
these costs will be employee severance and related benefits for affected employees in an estimated
range of approximately $3.5 million to $4.0 million, all of which relate to the Products segment.
These amounts will be paid in 2008 upon the successful transfer of production to Indianapolis and
satisfactory performance by the affected employees during the transition period. Severance charges
of $0.7 million and $1.3 million have been recognized in the quarter ended June 30, 2007 and for
the year to date, respectively. In the three months ended June 30, 2007, $1.9 million, the cost of
validation batches for both Oncaspar and Adagen, was expensed and included in cost of product
sales. We expect to incur other costs related to the relocation of goods and equipment, including
additional validation of production processes transferred to Indianapolis and we will recognize
such costs as incurred. In the aggregate, including employee and validation costs, we anticipate
incurring costs in connection with this restructuring plan in the range of $8.0 million to $10.0
million, a portion of which has and will be classified as cost of product sales.
In addition, we may experience costs associated with lease termination or sublease of the
South Plainfield facility of as much as $8.0 million. Such costs would be incurred and recognized
when we cease use of the property in 2008. However, we do not know at this time what the final use
or disposition of the leased South Plainfield facility will be. There is also a possibility that
non-cash charges could be incurred related to asset impairments or acceleration of depreciation, if
future triggering events occur. At June 30, 2007, our analysis of the future net undiscounted cash
flows for the South Plainfield facility assets did not indicate an impairment.
17
Table of Contents
Royalties Segment
(millions of dollars)
Three Months Ended | Six Months Ended | |||||||||||||||||||||||
June | % | June | June | % | June | |||||||||||||||||||
2007 | Change | 2006 | 2007 | Change | 2006 | |||||||||||||||||||
Royalty revenue |
$ | 18.3 | 2 | $ | 18.0 | $ | 34.6 | (2 | ) | $ | 35.2 | |||||||||||||
Total royalties of $18.3 million for the three months ended June 30, 2007 were 2% higher than
the $18.0 million during the comparable three-month period ended June 30, 2006. Total royalties
for the six months ended June 30, 2007 decreased 2% to $34.6 million as compared to $35.2 million
during the comparable six-month period ended June 30, 2006.
Growth in sales of PEG-INTRON, from which we derive the majority of our royalty revenue,
offset the effects of competition for Macugen in the U.S.
Costs and expenses
Current royalty revenues do not require any material specific maintenance costs. At some
point in the future, costs associated with initiation of new outlicensing agreements that could
result in our receipt of a royalty stream and, if necessary, costs necessary to maintain the
underlying technology may be charged to the Royalties segment.
Contract Manufacturing Segment
(millions of dollars)
Three Months Ended | Six Months Ended | |||||||||||||||||||||||
June | % | June | June | % | June | |||||||||||||||||||
2007 | Change | 2006 | 2007 | Change | 2006 | |||||||||||||||||||
Revenues |
$ | 5.9 | 15 | $ | 5.1 | $ | 8.4 | 1 | $ | 8.3 | ||||||||||||||
Cost of sales |
4.0 | 30 | 3.1 | 6.5 | 17 | 5.5 | ||||||||||||||||||
Segment profit |
$ | 1.9 | (9 | ) | $ | 2.0 | $ | 1.9 | (33 | ) | $ | 2.8 | ||||||||||||
Revenues
Contract manufacturing revenue for the three-month and six-month periods ended June 30, 2007
was $5.9 million and $8.4 million, respectively. This compares to $5.1 million and $8.3 million
for the comparable periods of 2006. The increase in contract manufacturing revenue was primarily
attributable to the timing of shipments to customers, reversing some of our first-quarter 2007
timing issues. Offsetting this, in part, in the three months ended June 30, 2006, we settled a
matter with one of our customers resulting in recognition of an additional $0.9 million of revenue.
It is not uncommon for the timing of shipments to cause quarter-over-quarter fluctuations.
Cost of sales
Cost of sales for contract manufacturing for the three months ended June 30, 2007 was $4.0
million or 69% of sales. This compares to $3.1 million or 61% of sales for the comparable
three-month period of 2006. On a year-to-date basis, cost of contract manufacturing was $6.5
million or 78% of sales in 2007 compared to $5.5 million or 67% of sales in 2006. The
second-quarter 2006 revenue settlement with one of our customers referred to above distorted these
comparisons. If 2006 sales are adjusted for the $0.9 million settlement, then cost of sales would
have been 74% of sales for the three months ended June 30, 2006 compared to 69% in the same period
in 2007 and 75% of sales for the six months ended June 30, 2006 compared to 78% for the same period
in 2007. Elevated costs in the first quarter of 2007 due to start-up of production related to a
newly negotiated agreement contributed to the higher six-months 2007 cost of sales.
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Non-U.S Revenue
During the three months ended June 30, 2007, we had export sales and royalties on export sales
of $21.0 million, of which $13.8 million were in Europe. This compares to $16.0 million of export
sales in the comparable three-month period of 2006, of which $9.6 million were in Europe.
We had export sales and royalties on export sales of $36.6 million and $31.8 million, of which
$22.6 million and $18.1 million were in Europe, for the six months ended June 30, 2007 and 2006,
respectively.
Corporate and Other Expense
(millions of dollars)
Three Months Ended | Six Months Ended | |||||||||||||||||||||||
June | % | June | June | % | June | |||||||||||||||||||
2007 | Change | 2006 | 2007 | Change | 2006 | |||||||||||||||||||
Research and development |
$ | 14.0 | 66 | $ | 8.5 | $ | 24.8 | 75 | $ | 14.2 | ||||||||||||||
General and administrative |
7.7 | 3 | 7.6 | 15.8 | 4 | 15.3 | ||||||||||||||||||
Other (income) expense: |
||||||||||||||||||||||||
Investment income, net |
(2.3 | ) | (23 | ) | (3.1 | ) | (4.9 | ) | (74 | ) | (18.9 | ) | ||||||||||||
Interest expense |
4.4 | (32 | ) | 6.6 | 9.0 | (21 | ) | 11.5 | ||||||||||||||||
Other, net |
(.3 | ) | (93 | ) | (4.5 | ) | (.4 | ) | (90 | ) | (4.2 | ) | ||||||||||||
1.8 | n.m. | (1.0 | ) | 3.7 | n.m. | (11.6 | ) | |||||||||||||||||
Corporate and other
expenses |
$ | 23.5 | 56 | $ | 15.1 | $ | 44.3 | 148 | $ | 17.9 | ||||||||||||||
n.m. not meaningful |
Research and Development
For the three months ended June 30, 2007, corporate research and development expenses
increased by $5.5 million to $14.0 million as compared to the three months ended June 30, 2006.
For the six-month periods ended June 30, 2006 and 2007, research and development spending increased
from $14.2 million to $24.8 million, respectively. Included in the $24.8 million is $0.8 million
related to milestones, of which $0.6 million and $0.2 million were incurred in the three months
ended June 30, 2007 and March 31, 2007, respectively. As we have previously indicated, we are
investing in our research and development efforts in areas such as rhMBL, PEG-SN38, the HIF-1 alpha
antagonist and other LNA and PEGylation based programs. This has resulted in hiring of new
positions and associated costs. We anticipate that increased levels of research and development
expense will continue. In addition, milestone payments to third parties for the successful
advancement of our research and development pipeline are expected to total as much as $10.0 million
in 2007.
General and administrative
General and administrative expenses for the three- and six-month periods ended June 30, 2007
of $7.7 million and $15.8 million, respectively, was relatively unchanged when compared to $7.6
million and $15.3 million in the comparable periods in 2006. Certain legal and consulting costs
incurred in the first six months of 2006 were not experienced this year, however, incremental
share-based compensation costs offset these savings.
Other (income) expense
Other (income) expense for the three months ended June 30, 2007 was net expense of $1.8
million, as compared to net income of $1.0 million for the three months ended June 30, 2006. For
the six-month periods, other (income) expense was net expense of $3.7 million in 2007 versus a net
income of $11.6 million in 2006. Other (income) expense includes: net investment income, interest
expense and other, net.
Net investment income decreased by $0.8 million to $2.3 million for the three months ended
June 30, 2007 from $3.1 million for the three months ended June 30, 2006 due to more investments
outstanding in the comparative period ended June 30, 2006. Net investment income decreased by
$14.0 million to $4.9 million for the six months ended June 30, 2007 from $18.9 million for the six
months ended June 30, 2006. The six months decrease was principally due to the sale in January
and February 2006 of our remaining 1,023,302
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shares of Nektar Therapeutics, Inc. common stock which resulted in a net gain of $13.8 million
and cash proceeds of $20.2 million.
Interest expense was $4.4 million and $9.0 million for the three-month and six-month periods
ended June 30, 2007 and $6.6 million and $11.5 million for the three-month and six-month periods
ended June 30, 2006, respectively. The reduction in interest expense is attributable to the
lowering of effective interest rates on our outstanding notes payable through refinancing.
Outstanding notes payable at the beginning of 2006 in the amount of $394.0 million bore interest at
4.5%. In May and July 2006, $133.8 million and $137.6 million principal amount, respectively, of
these notes were repurchased using the proceeds of the May 2006 issuance of $275.0 million 4.0%
notes. The net result of these transactions was to replace $271.4 million of 4.5% notes with
$275.0 million 4.0% notes, resulting in an annualized interest cost savings of approximately $1.4
million. Additional redemptions of our 4.5% notes, including $15.9 million principal amount during
the six months ended June 30, 2007, have taken place over the past year and a half, reducing the
outstanding balance as of June 30, 2007 to $106.7 million, further contributing to savings of
interest expense.
Other, net was a net income of $0.3 million for the three months ended June 30, 2007, as
compared to a net income of $4.5 million for the three months ended June 30, 2006. For the six
months ended June 30, 2007, other, net was a net income of $0.4 million versus a net income of $4.2
million for the six months ended June 30, 2006. The change resulted primarily from the
second-quarter 2006 debt refinancing which included a $4.4 million gain on the repurchase of the
4.5% notes.
Income taxes
During the three months and six months ended June 30, 2007, we recorded a tax expense of
approximately $0.3 million and $0.1 million, respectively, which represents state and Canadian tax
liabilities and includes an adjustment to taxes payable. During the three months and six months
ended June 30, 2006, we recorded a tax expense of $0.3 million and $0.4 million, respectively,
representing state and Canadian taxes payable. No federal income tax provision was recorded for
the three months and six months ended June 30, 2007 as the estimated annual effective tax rate is
zero due to our ability to utilize our federal net operating loss carryforwards to eliminate our
projected taxable income.
Our adoption, as of January 1, 2007, of FASB Interpretation No. 48, Accounting for
Uncertainty in Income Taxes (FIN 48), had no effect on income tax expense. In accordance with FIN
48, as amended, tax benefits of uncertain tax positions are recognized only if it is more likely
than not we will be able to sustain a position taken on an income tax return. We have no tax
positions relating to open income tax returns that we consider to be uncertain.
Liquidity and Capital Resources
Total cash reserves, which include cash, cash equivalents, short-term investments and
marketable securities, were $187.1 million as of June 30, 2007, as compared to $240.6 million as of
December 31, 2006. The decrease is primarily due to the redemption of a portion of our notes
payable as well as reductions in current liabilities. During the quarter ended June 30, 2007, we
redeemed $11.9 million principal amount of our 4.5% notes bringing year-to-date redemptions to
$15.9 million. In addition, accounts payable and accrued expenses at June 30, 2007 were
approximately $32.0 million lower than at December 31, 2006. The December 2006 liabilities
included $17.5 million owed under a December 2006 supply and license agreement with Ovation
Pharmaceuticals, Inc., a $5.0 million milestone payment to Santaris Pharma A/S related to HIF-1
alpha and $7.0 million in legal fees incurred in connection with securing Oncaspar raw material.
We invest our excess cash primarily in United States government and government-sponsored enterprise
securities, investment-grade corporate debt securities and auction rate securities.
Cash used in operating activities totaled $9.8 million for the six months ended June 30, 2007
compared to cash provided by operating activities of $23.8 million for the six months ended June
30, 2006. Operating income recognized in the first half of 2006 of $32.7 million turned to an
operating loss of $4.9 million for the six-month period ended June 30, 2007 due, in large part, to
a $14.5 million increase in research and development costs, a $4.9 million increase in cost of
product sales and contract manufacturing as a result of validation costs incurred in connection
with the proposed transfer of production from South Plainfield to Indianapolis, and a net gain of
$13.8 million on the sale of our remaining shares of Nektar Therapeutics, Inc. in the first quarter
of 2006.
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Cash was provided by investing activities in the six months ended June 30, 2007 in the amount
of $20.8 million compared to a use of cash of $67.3 million in the six-month period of 2006. In
the six-month period ended June 30, 2007, maturities and proceeds from sale of marketable
securities totaling $214.3 million were used to purchase $164.5 million of marketable securities
resulting in a net increase in cash of $49.8 million. This increase in cash was used to purchase
property and equipment and product rights totaling $29.1 million.
The use of $15.7 million for the redemption of $15.9 million principal amount of our 4.5%
notes payable during the six months ended June 30, 2007 constituted our primary financing activity.
In addition, we received $0.3 million related to the exercise of employee stock options and $0.2
million related to the ESPP which became effective April 1, 2007.
As of June 30, 2007, we had $381.7 million of convertible notes outstanding. The 4.5% notes
in the principal amount of $106.7 million are subordinated to all existing and future senior
indebtedness of the Company, including the $275.0 million of 4% convertible senior notes issued
during the second quarter of 2006. Interest is payable on January 1 and July 1 of each year on the
4.5% notes and on June 1 and December 1 of each year on the 4% notes. During the six-month periods
ended June 30, 2007 and June 30, 2006, there were payments of interest of $8.5 million and $11.2
million, respectively. Accrued interest on the aggregate amount of the notes outstanding was $3.3
million as of June 30, 2007 and $3.7 million as of December 31, 2006.
Our current sources of liquidity are: our cash reserves; interest earned on such cash
reserves; sales of Oncaspar, DepoCyt, Abelcet and Adagen; royalties earned, which are
primarily related to sales of PEG-INTRON; and contract manufacturing revenue. Based upon our
current 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 and operational requirements for the near future; however we may
refinance or seek new financing to meet the payments due upon maturity of our remaining 4.5%
convertible subordinated notes in 2008. We will likely 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, debt retirement 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 June 30, 2007, we were not involved in any SPE transactions.
Our 4% notes payable are convertible into shares of our common stock at a conversion price of
$9.55 per share and pose a reasonable likelihood of potential significant dilution. The maximum
potential dilutive effect of conversion of the 4% notes is 28.8 million shares. Our 4.5% notes
have a conversion price of $70.98 per share. Consequently, dilution related to the 4.5% notes is
remote. Notes payable are discussed in greater detail in Liquidity and Capital Resources above and
in the notes to our condensed consolidated financial statements.
In addition, stock options to purchase 8.5 million shares of our common stock at a weighted
average exercise price of $11.40 per share and 1.6 million restricted stock units were outstanding
at June 30, 2007 that represent additional potential dilution.
Contractual Obligations
Our major outstanding contractual obligations relate to our operating leases, inventory
purchase commitments, convertible debt, and license agreements with collaborative partners.
For the three-month period ended June 30, 2007 we repurchased $11.9 million principal amount
of our 4.5% notes. There have been no other material changes with respect to our contractual
obligations as disclosed under Managements Discussion and Analysis of Financial Condition and
Results of Operations Contractual
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Obligations in our Annual Report on Form 10-K for the year ended December 31, 2006, other than
as described below.
During the three months ended March 31, 2007, we made payments of $5.0 million relating to the
milestone for filing the HIF-1 alpha antagonist IND, $17.5 million to Ovation to secure the
long-term supply of L-asparaginase, and $7.0 million for related legal services associated with the
new supply agreement. In addition, we repurchased $4.0 million principal amount of our 4.5% notes
during the three months ended March 31, 2007.
Critical Accounting Policies and Estimates
A critical accounting policy is one that is both important to the portrayal of a companys
financial condition and results of operations and requires managements 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 accounting standards effective as of June
30, 2007 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 critical because
changes to certain judgments and assumptions inherent in these policies could affect our
consolidated financial statements.
We base our estimates, to the extent possible, on historical experience. Historical
information is modified as appropriate based on current business factors and various assumptions
that we believe are necessary to form a basis for making judgments about the carrying value of
assets and liabilities. We evaluate our estimates on an ongoing basis and make changes when
necessary. Actual results could differ from our estimates.
Revenues
Revenues from product sales and contract manufacturing revenue are recognized when title
passes to the customer as described below. For product sales, we also record a provision at the
time of shipment for estimated future credits, chargebacks, sales discounts, rebates and returns.
These sales provision accruals, except for rebates which are recorded as a liability, 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 recognize revenues for Abelcet at the time of sale to the wholesaler. Sales of Oncaspar
and DepoCyt are recorded when product is shipped by our third-party distributor to the end-user.
Adagen is sold directly to a specialty distributor that then sells the product to end-users. We
recognize revenue for Adagen upon sale to the specialty distributor. We recognize revenue on
contract manufactured products upon shipment.
We provide chargeback payments to wholesalers based on their sales to members of buying groups
at prices determined under a contract between us and the member. Administrative fees are paid to
buying groups based on the total amount of purchases by their members. We estimate the amount of
the chargeback that will be paid using (a) distribution channel information obtained from certain
of our wholesalers which allows us to determine the amount and expiry of inventory in the
distribution channel and (b) historical trends, adjusted for current conditions. The settlement of
the chargebacks generally occurs within three months after the sale to the wholesaler. We
regularly analyze the historical chargeback trends and make adjustments to recorded reserves for
changes in trends.
In addition, state agencies that administer various programs, such as the U.S. Medicaid
programs, receive rebates. Medicaid rebates and administrative fees are recorded as a liability
and a reduction of gross sales when we record the sale of the product. In determining the
appropriate accrual amount, we use (a) distribution channel information obtained from certain of
our wholesalers which allows us to determine the amount and expiry of inventory in the distribution
channel, (b) our historical rebate and administrative fee payments by product as a percentage of
our historical sales and (c) any significant changes in sales trends. Current Medicaid rebate laws
and interpretations, and the percentage of our products that are sold to Medicaid
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patients are also evaluated. Factors that complicate the rebate calculations are the timing of the
average manufacturer pricing computation, the lag time between sale and payment of a rebate, which
can range up to nine months, and the level of reimbursement by state agencies.
The following is a summary of reductions of gross sales accrued as of June 30, 2007 and
December 31, 2006 (in thousands):
December 31, | ||||||||
June 30, 2007 | 2006 | |||||||
Accounts Receivable Reductions |
||||||||
Chargebacks |
$ | 2,710 | $ | 3,388 | ||||
Cash Discounts |
120 | 168 | ||||||
Other (including returns) |
1,839 | 1,767 | ||||||
Total |
4,669 | 5,323 | ||||||
Accrued Liabilities |
||||||||
Medicaid Rebates |
1,253 | 1,335 | ||||||
Administrative Fees |
173 | 205 | ||||||
Total |
1,426 | 1,540 | ||||||
Grand Total |
$ | 6,095 | $ | 6,863 | ||||
Royalties under our license agreements with third parties are recognized as revenue when
reasonably estimable and earned through the sale of the product by the licensee net of future
credits, chargebacks, sales discount rebates and refunds and product returns and collection is
reasonably assured. Notification from the third party licensee of the royalties earned under the
license agreement is the basis for royalty revenue recognition. This information is generally
received from the licensees in the quarter subsequent to the period in which the sales occur.
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.
Income Taxes
Under the asset and liability method of Financial Accounting Standards Board (FASB) Statement
of Financial Accounting Standards (SFAS) No. 109, Accounting for Income Taxes (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. 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 believe, based on future projections, that it is more likely than
not that our net deferred tax assets, including our net operating losses from operating activities
and stock option exercises, will not be realized.
In accordance with FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes
(FIN 48), as amended May 2, 2007, tax benefits of uncertain tax positions are recognized only if it
is more likely than not that we will be able to sustain a position taken on our income tax return.
Available-for-Sale Securities
We assess the carrying value of our available-for-sale securities in accordance with FASB
Staff Position (FSP) 115-1, The Meaning of Other-Than-Temporary Impairment and Its Application to
Certain Investments. 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.
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Long-Lived Assets
Long-lived assets, including amortizable intangible assets are tested for impairment in
accordance with the provisions of SFAS No. 144, Accounting for the Impairment or Disposal of
Long-Lived Assets. This testing is performed when an impairment indicator is present. An
impairment indicator is one or more events or circumstances that may be indicative of possible
impairment such as a significant adverse change in legal factors or in business climate, a current
period operating loss combined with a history of operating losses or a projection or forecast that
demonstrates continuing losses associated with the use of a long-lived asset or asset group.
SFAS No. 144 testing for the recoverability of long-lived assets is performed initially by
comparing the carrying amount of the asset to the future undiscounted net cash flows to be
generated by the asset or asset group. If the undiscounted net cash flow stream exceeds the
carrying amount, no further analysis is required. However, if this test shows a negative
relationship, the fair value of the intangible assets must be estimated and we would record an
impairment charge for any excess of the carrying amount over the fair value. These evaluations
involve amounts that are based on managements best estimates and judgment. Actual results may
differ from these estimates.
Share-Based Payment
We account for share-based compensation in accordance with SFAS No. 123R, Share-Based
Payment. SFAS No. 123R establishes standards for the accounting for transactions in which an
entity exchanges its equity instruments for goods or services and requires that the compensation
cost relating to share-based payment transactions be recognized in the financial statements,
measured by the fair value of the equity or liability instruments issued, adjusted for estimated
forfeitures. We use historical data to estimate the forfeiture rate.
The fair value of the option component of employee stock purchases under the ESPP, is
determined in accordance with SFAS No. 123R and FASB Technical Bulletin 97-1, Accounting under
Statement 123 for Certain Employee Stock Purchase Plans with a Look-Back Option. Our ESPP was
newly adopted in January 2007.
Options or stock awards issued to non-employees and consultants are recorded at their fair
value as determined in accordance with SFAS No. 123R and EITF No. 96-18, Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services, and recognized over the related vesting or service period.
Fair value of share-based payments is determined using the Black-Scholes valuation model which
employs weighted average assumptions for expected volatility of the Companys stock, expected term
until exercise of the options or purchase of shares in the case of the ESPP, the risk free interest
rate, and dividends, if any. Expected volatility is based on historical Enzon stock price
information for periods comparable to the expected term of the respective awards or, in the case of
the ESPP, the length of the offering period.
We have elected the modified prospective transition method which requires that compensation
costs be recorded, as earned, for all unvested stock options and restricted stock awards and
restricted stock units outstanding at July 1, 2005.
Recently Issued Accounting Standards
The FASB has issued two pronouncements that will become effective for us as of the first
quarter of 2008 relating to measuring financial instruments at fair value. We are in the process
of evaluating the new standards but do not, at this time, anticipate that either will have any
material effect on our consolidated financial position or results of operations. Certain financial
statement disclosures will be revised, however, to conform to the new guidance. SFAS No. 157,
Fair Value Measurements provides guidance on the use of fair value in such measurements and
prescribes expanded disclosures about fair value measurements contained in financial statements.
Once SFAS No. 157 is adopted, SFAS No. 159 can be adopted which allows companies the option to
measure many financial assets and financial liabilities at fair value on a contract-by-contract
basis.
The Emerging Issues Task Force of the FASB reached a consensus in June 2007 that
non-refundable advance payments to acquire goods or pay for services that will be consumed or
performed in a future period in conducting research and development activities on behalf of the
entity should be recorded as an asset when the advance payments are made (EITF 07-3, Accounting
for Advance Payments for Goods or Services to Be Used
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in Future Research and Development Activities). Capitalized amounts are to be recognized as
expense when the research and development activities are performed, that is, when the goods without
alternative future use are acquired or the service is rendered. The consensus is to be applied
prospectively to new contractual arrangements entered into in fiscal years beginning after December
31, 2007. We are evaluating the effect of adoption of EITF 07-3, but do not expect it to be
material to our financial position or results of operations.
Factors That May Affect Future Results
There are forward-looking statements contained herein, which can be identified by the use of
forward-looking terminology such as the words believes, expects, may, will, should,
potential, anticipates, plans or intends and similar expressions. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors that may cause actual
results, events or developments to be materially different from the future results, events or
developments indicated in such forward-looking statements. Such factors include, but are not
limited to:
| The risk that we will not achieve success in our research and development efforts, including clinical trials conducted by us or our collaborative partners. | ||
| The risk that we will experience operating losses for the next several years. | ||
| The risk that there will be a decline in sales of one or more of our marketed products or products sold by others from which we derive royalty revenues. Such sales declines could result from increased competition, loss of patent protection, pricing, supply shortages and/or regulatory constraints. | ||
| The risk that we will be unable to obtain critical compounds used in the manufacture of our products at economically feasible prices or at all, or one of our key suppliers will experience manufacturing problems or delays. | ||
| Decisions by regulatory authorities regarding whether and when to approve our regulatory applications as well as their decisions regarding labeling and other matters could affect the commercial potential of our products or developmental products. | ||
| The risk that we will fail to obtain adequate financing to meet our future capital and financing needs. | ||
| The risk that key personnel will leave the Company. |
A more detailed discussion of these and other factors that could affect our results is
contained in our filings with the U.S. Securities and Exchange Commission, including our Annual
Report on Form 10-K for the year ended December 31, 2006. These factors should be considered
carefully and readers are cautioned not to place undue reliance on such forward-looking statements.
No assurance can be given that the future results covered by the forward-looking statements will
be achieved. All information contained herein is as of the date of this report and we do not intend
to update this information.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our holdings of financial instruments are comprised of debt securities and time deposits. All
such instruments are classified as securities available-for-sale. Apart from custodial accounts
related to the Executive Deferred Compensation Plan, we do not invest in portfolio equity
securities. We do not invest in commodities or use financial derivatives for trading purposes.
Our debt security portfolio represents funds held temporarily pending use in our business and
operations. We manage these funds accordingly. We seek reasonable assuredness of the safety of
principal and market liquidity by investing in rated fixed income securities while at the same time
seeking to achieve a favorable rate of return. Our market risk exposure consists principally of
exposure to changes in interest rates. Our holdings also are exposed to the risks of changes in
the credit quality of issuers which are rated A1 or better. We typically invest the majority of
our investments in the shorter-end of the maturity spectrum.
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The table below presents the principal amounts and related weighted average interest rates of
our marketable debt securities, excluding those related to our Executive Deferred Compensation
Plan, by year of maturity (twelve-month intervals ending June 30 of the year indicated) as of June
30, 2007 (in thousands):
Maturities | ||||||||||||||||||||
Beyond | Amortized | |||||||||||||||||||
2008 | 2009 | Five Years | Cost | Fair Value | ||||||||||||||||
Fixed Rate |
$ | 109,985 | $ | 7,030 | $ | | $ | 117,015 | $ | 116,766 | ||||||||||
Average Interest Rate |
4.70 | % | 5.39 | % | | 4.74 | % | |||||||||||||
Variable Rate |
17,750 | | 26,035 | 43,785 | 43,728 | |||||||||||||||
Average Interest Rate |
4.62 | % | | 5.23 | % | 4.98 | % | |||||||||||||
$ | 127,735 | $ | 7,030 | $ | 26,035 | $ | 160,800 | $ | 160,494 | |||||||||||
Our convertible notes payable outstanding have fixed interest rates. Accordingly, the fair
values of the respective issues will fluctuate as market rates of interest rise or fall. Fair
values are also affected by changes in the price of our common stock.
Our 4% convertible senior unsecured notes in the principal amount of $275.0 million at June
30, 2007 are due June 1, 2013 and have a fair value of $283.5 million at June 30, 2007.
Our 4.5% convertible subordinated notes in the principal amount of $106.7 million are due July
1, 2008 and have a fair value of $105.3 million at June 30, 2007.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures.
Our management, under the direction of our Chief Executive Officer and Chief Financial
Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in
Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, (the Exchange
Act)) as of June 30, 2007. Based on the evaluation, our Chief Executive Officer and Chief
Financial Officer have concluded that our disclosure controls and procedures were effective as of
June 30, 2007.
Changes in Internal Controls
There were no changes in our internal controls over financial reporting as such term is
defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during the period covered by this
report that have materially affected, or are reasonably likely to materially affect our internal
control over financial reporting.
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PART II OTHER INFORMATION
Item 4. Submission of Matters to a Vote of Security Holders
(a) | An annual meeting of stockholders was held on May 16, 2007. | ||
(b) | Jeffrey H. Buchalter, Goran A. Ando, M.D. and Victor P. Micati were re-elected as Class II directors of the Company. The term of office, as a director for each of Philip M. Renfro, Rolf A. Classon, Robert LeBuhn and Robert C. Salisbury, continued after the annual meeting. | ||
(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. All proposals were approved by the requisite percentage: |
(i) | The stockholders voted 37,167,097 shares in favor and 2,677,775 shares withheld with respect to the election of Jeffrey H. Buchalter as a Class II director of the Company. | ||
The stockholders voted 37,435,838 shares in favor and 2,409,034 withheld with respect to the election of Goran A. Ando, M.D. as a Class II director of the Company. | |||
The stockholders voted 37,416,039 shares in favor and 2,428,833 withheld with respect to the election of Victor P. Micati as a Class II director of the Company. | |||
(ii) | The stockholders voted 30,678,163 shares for, 763,286 shares against and 267,234 shares abstained and 8,136,189 shares were not voted with respect to the approval of the 2007 Employee Stock Purchase Plan. | ||
(iii) | The stockholders voted 39,332,523 shares in favor, 467,533 shares against and 44,816 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 December 31, 2007. |
Item 5. Other Information
On
July 31, 2007, the Board of Directors (the Board) of the Company adopted an Amendment
(the Amendment) to the Amended and Restated Bylaws of Enzon Pharmaceuticals, Inc. (the Bylaws) to
modify the procedures regarding advance notice of stockholder business and nominations of directors
at meetings of stockholders. The Amendment was effective as of
July 31, 2007.
Under the Amendment, Article II, Section 2.15 of the Bylaws was amended in its entirety to
address, among other things, the timeliness and nature of notice of stockholder business proposals
and nominations of directors at both annual and special meetings of stockholders. With respect to
proposed business, the provision provides that no business may be transacted at the annual meeting
unless it is either specified in the notice of the meeting given by or at the direction of the
Board, properly brought by or at the direction of the Board, or properly brought by a stockholder
of record complying with the notice provisions contained in Section 2.15 of the Bylaws, as amended.
With respect to director nominations, only directors nominated in accordance with the procedures
set forth in Section 2.15, except as may be otherwise provided in the Companys Certificate of
Incorporation with respect to the right of holders of preferred stock to nominate and elect a
specified number of directors in certain circumstances, are eligible for election as directors.
Under the provision, directors may be nominated for election at either an annual meeting or special
meeting by or at the direction of the Board or by a stockholder of record who complies with the
notice procedures set forth in the same Section 2.15, as amended.
For annual meetings, the Amendment provides that, in order to be timely, stockholder notices
must be delivered not earlier than the 150th day, but not later than the 120th day, prior to the
anniversary date of the preceding years annual meeting, except where the date of the annual
meeting is not within twenty-five (25) days before or after such anniversary date, in which case
notice must be received not later than the close of business on the 10th day following the day on
which the notice of the date of the annual meeting was mailed or the meeting was publicly
announced, whichever occurs first. In the case of nominations of directors at a special meeting
called for the purpose of electing directors, notice must be received no later than the close of
business on the 10th day following the day on which notice of the special meeting was mailed or the
special meeting was publicly announced, whichever occurs first.
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In addition, Section 2.15, as amended, requires that a stockholder proposing a matter to be
considered at an annual meeting submit a notice setting forth a brief description of such proposal
and the reasons for conducting such business at the annual meeting, his or her name and address,
number and class of shares held by such stockholder, a description of any arrangement or
understanding between the stockholder and any other persons connected to the proposal and any
material interest that the stockholder might have in the proposal, and a representation that the
shareholder intends to appear at the annual meeting in person or by proxy to bring such business
before the annual meeting.
For nominations of directors at an annual or special meeting, the provision requires that
notice be delivered to the Companys Secretary setting forth, with respect to each director
nominee, the nominees name, age, address and occupation, the number and class of shares held by
the nominee, and all other information required by the Securities Exchange Act of 1934 in
connection with solicitation of proxies for election of directors. With respect to the shareholder
proposing the nomination, the notice must include, his/her/its name and address, number and class
of shares held by such stockholder, a description of any arrangement or understanding between the
stockholder and each proposed nominee, a representation that the shareholder intends to appear at
the annual meeting in person or by proxy, and all other information required by the Securities
Exchange Act of 1934 in connection with solicitation of proxies for election of directors. The
notice must be accompanied by the written consent of the proposed nominee to being named as a
nominee and to serve as a director if elected.
Under the Amendment, no business shall be conducted at any annual meeting unless that which is
brought in accordance with the provisions of Section 2.15; however, once business has been properly
brought, nothing precludes discussion by any stockholder of any such business. In addition, if the
chairman of any annual meeting determines business was not properly brought, or if the chairman of
any annual or special meeting determines that a nomination was not properly made, then he shall
declare the same and such business shall not be transacted and such nominee shall be disregarded.
Previously, Article II, Section 2.15 of the Bylaws contained different requirements for the
delivery of stockholder notices, proposal of business and nomination of directors. The provision
provided that nominations for directors or business proposals at any stockholder meeting could be
made by the Board or proxy committee appointed by the Board, or any stockholder entitled to vote at
the meeting provided such stockholder delivered notice to the Company not later than one hundred
twenty (120) days prior to such meeting. To be in proper form, such notice required the name and
address of the stockholder and, if applicable, the name and address of person(s) to be nominated, a
representation that said stockholder intended to appear at the meeting in person or by proxy, a
description of all arrangements or understandings between said stockholder and each nominee, if
applicable, any other information regarding each nominee or business proposals required to be
included in a proxy statement filed in accordance to the proxy rules of the Securities and Exchange
Commission, and the consent of each nominee, if applicable. The chairman of the meeting could
refuse the nomination of any person or proposal of any business not made in compliance with the
notice procedures.
The foregoing description of the Amendment is a general description only and is qualified in
its entirety by reference to such Amendment. A copy of the Amendment as currently in effect is
attached as Exhibit 3(iii) hereto and incorporated herein by reference.
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Item 6. Exhibits
(a) Exhibits required by Item 601 of Regulation S-K.
Exhibit | Reference | |||||
Number | Description | No. | ||||
3(i)
|
Amended and Restated Certificate of Incorporation | (1 | ) | |||
3(ii)
|
Amended and Restated Bylaws | (2 | ) | |||
3(iii)
|
Amendment dated July 31, 2007 to the Amended and Restated Bylaws | * | ||||
4.1
|
Rights Agreement dated May 17, 2002 between the Company and Continental Stock Transfer Trust Company, as rights agent | (3 | ) | |||
4.2
|
First Amendment to the Rights Agreement, dated as of February 19, 2003 between the Company and Continental Stock Transfer & Trust Company, as rights agent | (4 | ) | |||
10.1
|
2007 Outside Director Compensation Plan ** | * | ||||
31.1
|
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | * | ||||
31.2
|
Certification of Principal Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | * | ||||
32.1
|
Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | * | ||||
32.2
|
Certification of Principal Accounting Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | * |
* | Filed herewith. | |
** | Management contracts or compensatory plans and arrangements required to be filed pursuant to Item 601(b) (10) (ii) (A) or (iii) of Regulation S-K. |
Referenced exhibit was previously filed with the Commission as an exhibit to the
Companys filing indicated below and is incorporated herein by reference to that filing:
(1) | Current Report on Form 8-K filed May 19, 2006. | |
(2) | Quarterly Report on Form 10-Q for the quarter ended June 30, 2006 filed on August 3, 2006. | |
(3) | Form 8-A12G (File No. 000-12957) filed with the Commission on May 22, 2002. | |
(4) | Form 8-A12G/A (File No. 000-12957) filed with the Commission on February 20, 2003. |
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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: August 2, 2007 | By: | /s/ Jeffrey H. Buchalter | ||
Jeffrey H. Buchalter | ||||
President and Chief Executive Officer (Principal Executive Officer) |
||||
Date: August 2, 2007 | By: | /s/ Craig A. Tooman | ||
Craig A. Tooman | ||||
Executive Vice President, Finance
and Chief Financial Officer (Principal Financial Officer) |
||||
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