ENZON PHARMACEUTICALS, INC. - Quarter Report: 2007 September (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 September 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 | 22-2372868 | |
(State of incorporation) | (I.R.S. Employer Identification No.) | |
685 Route 202/206, Bridgewater, New Jersey | 08807 | |
(Address of principal executive offices) | (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 No þ
Shares of Common Stock outstanding as of October 31, 2007: 44,170,815.
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)
September 30, 2007 | December 31, 2006* | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 21,360 | $ | 28,431 | ||||
Short-term investments |
141,529 | 145,113 | ||||||
Restricted investments and cash |
82,156 | | ||||||
Accounts receivable, net of allowance for doubtful accounts;
$289 at September 30, 2007 and $245 at December 31, 2006 |
13,788 | 15,259 | ||||||
Inventories |
20,627 | 17,618 | ||||||
Other current assets |
6,918 | 5,890 | ||||||
Total current assets |
286,378 | 212,311 | ||||||
Property and equipment, net of accumulated depreciation;
$36,288 at September 30, 2007 and $26,506 at
December 31, 2006 |
44,790 | 39,491 | ||||||
Marketable securities |
16,277 | 67,061 | ||||||
Amortizable intangible assets, net |
70,723 | 78,510 | ||||||
Other assets |
5,350 | 6,457 | ||||||
Total assets |
$ | 423,518 | $ | 403,830 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 7,027 | $ | 24,918 | ||||
Notes payable |
81,921 | | ||||||
Accrued expenses |
22,759 | 34,967 | ||||||
Total current liabilities |
111,707 | 59,885 | ||||||
Notes payable |
275,000 | 397,642 | ||||||
Other liabilities |
3,165 | 2,744 | ||||||
Total liabilities |
389,872 | 460,271 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity (deficit): |
||||||||
Preferred stock $.01 par value, authorized 3,000,000 shares;
no shares issued and outstanding at September 30, 2007 and
December 31, 2006 |
| | ||||||
Common stock $.01 par value, authorized 170,000,000 shares;
issued and outstanding 44,105,776 shares and 43,999,031
shares
at September 30, 2007 and December 31, 2006, respectively |
441 | 440 | ||||||
Additional paid-in capital |
332,452 | 326,099 | ||||||
Accumulated other comprehensive income (loss) |
534 | (414 | ) | |||||
Accumulated deficit |
(299,781 | ) | (382,566 | ) | ||||
Total stockholders equity (deficit) |
33,646 | (56,441 | ) | |||||
Total liabilities and stockholders equity (deficit) |
$ | 423,518 | $ | 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 | Nine months ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2007 | 2006 | 2007 | 2006 | |||||||||||||
Revenues: |
||||||||||||||||
Product sales, net |
$ | 24,874 | $ | 25,295 | $ | 72,542 | $ | 74,107 | ||||||||
Royalties |
18,206 | 18,705 | 52,840 | 53,889 | ||||||||||||
Contract manufacturing |
3,761 | 1,856 | 12,159 | 10,193 | ||||||||||||
Total revenues |
46,841 | 45,856 | 137,541 | 138,189 | ||||||||||||
Costs and expenses: |
||||||||||||||||
Cost of product sales and contract
manufacturing |
14,118 | 12,141 | 40,851 | 35,042 | ||||||||||||
Research and development |
10,814 | 10,599 | 41,793 | 27,068 | ||||||||||||
Selling, general and administrative |
14,274 | 14,299 | 46,561 | 45,384 | ||||||||||||
Amortization of acquired intangible assets |
171 | 184 | 541 | 558 | ||||||||||||
Acquired in-process research and development |
| 8,000 | | 8,000 | ||||||||||||
Restructuring charge |
5,513 | | 6,837 | | ||||||||||||
Total costs and expenses |
44,890 | 45,223 | 136,583 | 116,052 | ||||||||||||
Gain on sale of royalty interest, net |
88,666 | | 88,666 | | ||||||||||||
Operating income |
90,617 | 633 | 89,624 | 22,137 | ||||||||||||
Other income (expense): |
||||||||||||||||
Investment income, net |
2,689 | 2,831 | 7,632 | 21,731 | ||||||||||||
Interest expense |
(4,286 | ) | (5,912 | ) | (13,330 | ) | (17,432 | ) | ||||||||
Other, net |
497 | 4,813 | 914 | 9,048 | ||||||||||||
(1,100 | ) | 1,732 | (4,784 | ) | 13,347 | |||||||||||
Income before income tax provision |
89,517 | 2,365 | 84,840 | 35,484 | ||||||||||||
Income tax provision |
1,987 | 127 | 2,055 | 551 | ||||||||||||
Net income |
$ | 87,530 | $ | 2,238 | $ | 82,785 | $ | 34,933 | ||||||||
Earnings per common share basic |
$ | 1.99 | $ | 0.05 | $ | 1.89 | $ | 0.80 | ||||||||
Earnings per common share diluted |
$ | 1.23 | $ | 0.05 | $ | 1.25 | $ | 0.67 | ||||||||
Weighted average shares basic |
43,925 | 43,590 | 43,890 | 43,551 | ||||||||||||
Weighted average shares diluted |
74,344 | 43,590 | 72,818 | 57,658 | ||||||||||||
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)
Nine months ended | ||||||||
September 30, | ||||||||
2007 | 2006 | |||||||
Cash flows from operating activities: |
||||||||
Net income |
$ | 82,785 | $ | 34,933 | ||||
Adjustments to reconcile net income to net cash
provided by operating activities: |
||||||||
Depreciation and amortization |
12,481 | 9,889 | ||||||
Write-off of equipment |
5,124 | | ||||||
Share-based compensation |
6,064 | 3,489 | ||||||
Gain on sale of investments |
| (13,844 | ) | |||||
(Gain) loss on sale of property and equipment |
(26 | ) | 33 | |||||
Gain on redemption of notes payable |
(481 | ) | (9,212 | ) | ||||
Write-off and amortization of debt issuance costs |
1,386 | 3,889 | ||||||
Amortization of debt securities bond
premium/discount |
114 | 786 | ||||||
Changes in operating assets and liabilities |
(15,601 | ) | (344 | ) | ||||
Net cash provided by operating activities |
91,846 | 29,619 | ||||||
Cash flows from investing activities: |
||||||||
Purchase of property and equipment |
(15,231 | ) | (6,459 | ) | ||||
Proceeds from sale of equity investment |
| 20,209 | ||||||
Purchase of product rights |
(17,500 | ) | (35,000 | ) | ||||
Proceeds from sale of marketable securities |
159,110 | 164,200 | ||||||
Purchase of marketable securities |
(315,639 | ) | (541,104 | ) | ||||
Maturities of marketable securities |
129,742 | 305,650 | ||||||
Net cash used in investing activities |
(59,518 | ) | (92,504 | ) | ||||
Cash flows from financing activities: |
||||||||
Proceeds from exercise of common stock options |
395 | 625 | ||||||
Proceeds from employee stock purchase plan |
446 | | ||||||
Redemption of notes payable |
(40,240 | ) | (262,146 | ) | ||||
Proceeds from issuance of notes payable |
| 275,000 | ||||||
Cash payment for debt issuance costs |
| (7,726 | ) | |||||
Net cash (used in) provided by financing
activities |
(39,399 | ) | 5,753 | |||||
Net decrease in cash and cash equivalents |
(7,071 | ) | (57,132 | ) | ||||
Cash and cash equivalents at beginning of period |
28,431 | 76,497 | ||||||
Cash and cash equivalents at end of period |
$ | 21,360 | $ | 19,365 | ||||
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 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) 2007 Prior Period Interim Results
In the process of reporting the Companys financial position as of September 30, 2007 and
results of operations for the three- and nine-month periods then ended, two immaterial
misstatements of prior 2007 interim results were detected and have been correctly reflected in the
nine-month period ended September 30, 2007.
Share-based compensation was understated by approximately $0.9 million for the three months
ended March 31, 2007 with an offsetting understatement of additional paid-in capital. The
first-quarter misstatement resulted from the application of an incorrect amortization schedule to
certain newly issued option awards. The effect on the consolidated statement of operations for the
three months ended March 31, 2007 was to understate selling, general and administrative expense,
operating loss and net loss by $0.9 million each or two cents per diluted share.
Inventory valuation as of June 30, 2007 was understated by approximately $1.0 million with a
corresponding overstatement of cost of product sales in the Products segment. This was the result
of purchase variances not having been capitalized to inventory. In addition to the overstatement
of cost of product sales for the three months ended June 30, 2007, net loss were also overstated by
$1.0 million or three cents per diluted share.
Due
to the Companys net operating loss position, there would have been no income tax effect
related to the revisions.
In each case, the Company assessed the effect of these misstatements on the results as
reported for the first and second quarters of 2007 and concluded that they were quantitatively and
qualitatively immaterial.
(3) Investments and Marketable Securities
The Company classifies its investments in debt and equity securities as either short-term or
long-term based upon their maturities and the Companys intent and ability to hold them.
Short-term investments are further classified as restricted or unrestricted with restricted
investments and cash being held exclusively for the repayment or repurchase of the Companys 4.5%
convertible subordinated notes payable due July 1, 2008. Investments in marketable equity
securities and debt securities, including auction rate securities are classified as
available-for-sale.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Investments with maturities of one year or less are classified as current assets and
investments in debt securities with maturities greater than one year and marketable equity
securities are classified as noncurrent assets when the Company 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 equity (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 September 30, 2007
and December 31, 2006 were investments in state government bonds and corporate securities.
Restricted investments and cash are held in a separate account for the sole purpose of
repayment or repurchase of the Companys 4.5% convertible subordinated notes payable due July 1,
2008. As of September 30, 2007, restricted investments amounted to $57,392 and restricted cash
amounted to $24,764.
Other securities include investments of participants in the Companys Executive Deferred
Compensation Plan which are predominantly mutual fund shares totaling $2.2 million as of September
30, 2007 and $1.8 million as of December 31, 2006. In addition, other securities include $0.3
million of corporate equity securities as of September 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). The assets of the deferred compensation plan also include
cash ($0.6 million and $0.3 million at September 30, 2007 and December 31, 2006, respectively).
There is a non-current liability that offsets the aggregate deferred compensation plan assets.
The amortized cost, gross unrealized holding gains and losses, and fair value of the Companys
available-for-sale securities by major security type at September 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 |
$ | 15,502 | $ | 2 | $ | (35 | ) | $ | 15,469 | |||||||
U.S. corporate debt |
143,862 | 48 | (124 | ) | 143,786 | |||||||||||
Auction rate securities |
53,375 | | | 53,375 | ||||||||||||
Other |
2,183 | 385 | | 2,568 | ||||||||||||
$ | 214,922 | $ | 435 | $ | (159 | ) | $ | 215,198 | ||||||||
* | $141,529 is included in short-term investments, $57,392 in restricted investments and $16,277 in marketable securities. |
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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 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 in marketable securities. |
Maturities
of marketable debt securities, excluding $2.6 million, the majority of
which relates to the Companys
Executive Deferred Compensation Plan, at September 30, 2007 were as follows (in
thousands):
Twelve-Month | ||||||||
Periods Ending | ||||||||
September 30, | Amortized Cost | Fair Value | ||||||
2008 |
$ | 198,708 | $ | 198,592 | ||||
2009 |
11,031 | 11,013 | ||||||
Maturities beyond five years |
3,000 | 3,025 | ||||||
$ | 212,739 | $ | 212,630 | |||||
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 September
30, 2007.
The following table shows the fair values and gross unrealized losses 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 September 30,
2007 (in thousands):
Less Than 12 Months | 12 Months or Greater | |||||||||||||||
Fair | Unrealized | Fair | Unrealized | |||||||||||||
Value | Loss | Value | Loss | |||||||||||||
U.S. corporate debt (1) |
$ | 96,070 | $ | (108 | ) | $ | 10,918 | $ | (16 | ) | ||||||
U.S. Government and GSE debt (2) |
| | 9,967 | (35 | ) | |||||||||||
Total |
$ | 96,070 | $ | (108 | ) | $ | 20,885 | $ | (51 | ) | ||||||
(1) | The unrealized losses of $0.1 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 September 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)
(2) | The U.S. Government and GSE mortgage-backed securities 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 September 30, 2007. Unrealized losses are negligible at September 30, 2007. |
(4) Comprehensive Income
The following table reconciles net income to comprehensive income (in thousands):
Three months ended | Nine months ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2007 | 2006 | 2007 | 2006 | |||||||||||||
Net income |
$ | 87,530 | $ | 2,238 | $ | 82,785 | $ | 34,933 | ||||||||
Other comprehensive income: |
||||||||||||||||
Unrealized gain on available-for-sale
securities that arose during the period |
280 | 403 | 948 | 14,412 | ||||||||||||
Reclassification adjustment
for gain on available-for-sale securities
included in net income(1) |
| | | (13,844 | ) | |||||||||||
Total other comprehensive income |
280 | 403 | 948 | 568 | ||||||||||||
Comprehensive income |
$ | 87,810 | $ | 2,641 | $ | 83,733 | $ | 35,501 | ||||||||
(1) | Information has not been tax-effected due to an estimated annual effective tax rate of zero. |
(5) Earnings Per Common Share
Basic earnings per common share is computed by dividing the net 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 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. Assumed proceeds include share-based
compensation costs to be attributed to future service and not yet recognized, the cash paid by the
holders of stock options to exercise, withholding and contributions pursuant to the ESPP and the
excess, if any, of tax benefits that would be credited to additional paid-in capital related to
share-based compensation.
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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 reconciles the numerators and denominators of the basic and diluted
earnings per share computations for the three- and nine-month periods ended September 30, 2007 and
September 30, 2006 (amounts in thousands except per-share amounts):
Three Months | Nine Months | |||||||||||||||
Ended | Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2007 | 2006 | 2007 | 2006 | |||||||||||||
Earnings Per Common Share Basic: |
||||||||||||||||
Net income |
$ | 87,530 | $ | 2,238 | $ | 82,785 | $ | 34,933 | ||||||||
Weighted average common shares outstanding |
43,925 | 43,590 | 43,890 | 43,551 | ||||||||||||
Basic earnings per share |
$ | 1.99 | $ | 0.05 | $ | 1.89 | $ | 0.80 | ||||||||
Earnings Per Common Share Diluted: |
||||||||||||||||
Net income |
$ | 87,530 | $ | 2,238 | $ | 82,785 | $ | 34,933 | ||||||||
Add back interest expense on 4% convertible notes |
2,750 | * | 8,250 | 3,832 | ||||||||||||
Add back interest expense on 4.5% convertible notes |
1,055 | * | * | * | ||||||||||||
Adjusted net income |
$ | 91,335 | $ | 2,238 | $ | 91,035 | $ | 38,765 | ||||||||
Weighted average number of common shares outstanding |
43,925 | 43,590 | 43,890 | 43,551 | ||||||||||||
Incremental shares related to ESPP and vesting of
nonvested awards |
346 | * | 132 | * | ||||||||||||
Incremental shares assuming conversion of 4% notes |
28,796 | * | 28,796 | 14,107 | ||||||||||||
Incremental shares assuming conversion of 4.5% notes |
1,277 | * | * | * | ||||||||||||
Weighted-average number of common shares outstanding
and common share equivalents |
74,344 | 43,590 | 72,818 | 57,658 | ||||||||||||
Diluted earnings per share |
$ | 1.23 | $ | 0.05 | $ | 1.25 | $ | 0.67 | ||||||||
* | For the three months ended September 30, 2006, the effect of inclusion of all potentially dilutive common stock equivalents and related earnings effects would have been anti-dilutive. Consequently, reported diluted earnings per share is equal to basic earnings per share for the period. Approximately 30.5 million potentially dilutive common stock equivalents were anti-dilutive. For the nine-months ended September 30, 2007 and 2006, approximately 1.5 million and 4.0 million anti-dilutive common stock equivalents related to the 4.5% convertible notes, respectively, were excluded from the computations. |
(6) 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 September 30, 2007 and 2006, the Company recognized share-based
compensation expense of $1.5 million and $1.0 million, respectively, relating to stock option and
nonvested share awards. During the nine-month periods ended September 30, 2007 and 2006, the
Company recognized share-based compensation expense of $6.0 million and $3.5 million, respectively,
for these plans. Activity in options and nonvested shares during the nine-months ended September
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 $8.53 per share and fair values ranged from
$2.65 to $3.61 per share. The fair value in total during the nine months ended September 30, 2007
was $7.4 million. The nonvested shares granted during the nine months had a weighted average
grant-date fair value of $8.36 per share. The Company uses historical data to estimate forfeiture
rates.
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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 |
2,070 | 470 | ||||||
Exercised and vested |
(83 | ) | (59 | ) | ||||
Expired and forfeited |
(197 | ) | (58 | ) | ||||
Outstanding at September 30, 2007 |
8,498 | 1,811 | ||||||
Options vested and expected to vest at September 30, 2007 |
7,683 | |||||||
Options exercisable at September 30, 2007 |
5,154 | |||||||
As of September 30, 2007, there was $6.9 million of total unrecognized compensation cost
related to unvested options that the Company expects to recognize over a weighted-average period of
25 months and $10.9 million of total unrecognized compensation cost related to nonvested shares to
be recognized over a weighted-average period of 33 months.
Employee Stock Purchase Plan
In January 2007, the Board of Directors adopted the 2007 ESPP which was approved by the
Companys 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 may 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
ended September 30, 2007 may vary from those indicated above. Compensation expense recognized for
the ESPP was approximately $0.1 million for the nine months ended September 30, 2007, which was
recorded in the same expense categories in the 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
nine months ended September 30, 2007. Based upon the purchase price established as of September
30, 2007, 63,960 shares were allocated under the plan in October 2007.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(7) Inventories
As of September 30, 2007 and December 31, 2006 inventories consisted of the following (in
thousands):
September 30, 2007 | December 31, 2006 | |||||||
Raw materials |
$ | 9,902 | $ | 7,321 | ||||
Work in process |
4,936 | 4,444 | ||||||
Finished goods |
5,789 | 5,853 | ||||||
$ | 20,627 | $ | 17,618 | |||||
(8) Intangible Assets
As of September 30, 2007 and December 31, 2006 intangible assets consisted of the following
(in thousands):
Weighted | ||||||||||||
Average | ||||||||||||
September 30, | December 31, | Remaining | ||||||||||
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 |
24,846 | 17,059 | ||||||||||
$ | 70,723 | $ | 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 nine months ended September 30, 2007, amortization charged to
operations relating to intangible assets totaled $2.6 million and $7.8 million, respectively, of
which $2.4 million and $7.2 million, respectively, was classified in cost of product sales and
contract manufacturing. For the three months and nine months ended September 30, 2006,
amortization expense was $2.0 million and $6.1 million, respectively, of which $1.8 million and
$5.5 million, respectively, was charged to cost of product sales and contract manufacturing.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(9) Notes Payable
The table below reflects the composition of the notes payable balances as of September 30,
2007 and December 31, 2006 (in thousands):
September 30, 2007 | December 31, 2006 | |||||||
4.5% Convertible Subordinated Notes due
July 1, 2008 |
$ | 81,921 | * | $ | 122,642 | |||
4% Convertible Senior Notes due June 1, 2013 |
275,000 | 275,000 | ||||||
$ | 356,921 | $ | 397,642 | |||||
* | Classified as current liabilities as of September 30, 2007. |
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. Because the 4.5% notes mature in less than twelve months from September 30, 2007, they are
classified as current liabilities in the Companys condensed consolidated balance sheet as of
September 30, 2007. Cash of approximately $82.0 million needed for repayment or repurchase of the
remaining balance of the 4.5% notes payable outstanding as of September 30, 2007, has been set
aside in restricted investments and cash. The assets in this segregated account may be used only
for purposes of retiring the 4.5% notes.
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.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
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 $1.5 million being payable on the 4% notes as of
September 30, 2007. Beginning 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
September 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 $0.9 million as of September 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 September 30,
2007 accrued interest on the 4% notes amounted to $3.7 million, and $1.0 million as of 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 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.
(10) 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. All operations at the Companys South Plainfield, New
Jersey facility are expected to be transferred to the Companys Indianapolis facility 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 the Companys
Indianapolis facility and closure of the South Plainfield facility. The Company has recognized
severance costs of $0.4 million in the third quarter of 2007 and $1.7 million since inception of
the plan. Other costs are expected to be incurred relating to relocation and/or write-off of goods
and equipment and will be recognized as incurred.
During the third quarter 2007, management modified its original product transfer and
validation plan, resulting in the decommissioning of certain assets earlier than originally
expected at the South Plainfield facility. These assets consist primarily of manufacturing
equipment that will not be transferred to the Indianapolis facility, nor continue to be used in
manufacturing at the South Plainfield facility. Accordingly, the Company fully recognized the
remaining depreciation totaling $5.1 million on these assets during the third quarter of 2007.
In the three months ended June 30, 2007, $1.9 million, being the cost of validation batches at
the Indianapolis facility for Oncaspar and Adagen, was expensed and included in cost of product
sales. Additional expenses associated with the validation of production processes transferred to
Indianapolis, may be experienced and will be recognized as incurred.
In the aggregate, including employee and validation costs, the Company anticipates incurring
costs in 2007 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.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The Company may experience additional costs associated with lease termination or sublease of
the South Plainfield facility. Such costs will 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. At September 30, 2007, the Companys
analysis of the future net undiscounted cash flows for the South Plainfield facility assets did not
indicate an impairment apart from that of the specific assets referred to above.
(11) Gain on Sale of Royalty Interest
During the third quarter of 2007, the Company sold a 25% interest in future royalties payable
to it by Schering-Plough Corporation on net sales of PEG-INTRON occurring after June 30, 2007. The
purchaser of the 25% interest will be obligated to pay an additional $15.0 million to the Company
in the first quarter of 2012 if it receives a certain threshold level of royalties on sales of
PEG-INTRON occurring from July 1, 2007 through December 31, 2011. The gain on the sale of the
royalty interest, net of related costs, is $88.7 million. The $15.0 million contingent gain will
be recognized when and if the contingency is removed and collection is assured.
(12) 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 nine-month periods ended September
30, 2007 and 2006, there were payments of interest on the Companys notes payable of $11.1 million
and $17.2 million, respectively. Income tax payments for the nine months ended September 30, 2007
and 2006, were $0.5 million and $0.1 million, respectively.
(13) Income Taxes
During the three months and nine months ended September 30, 2007, the Company recorded a tax
expense of approximately $2.0 million and $2.1 million, respectively, which represents federal,
state and Canadian tax liabilities and includes an adjustment to taxes payable. During the three
months and nine months ended September 30, 2006, the Company recorded a tax expense of
approximately $0.1 million and $0.6 million, respectively, representing state and Canadian taxes
payable. The federal income tax provision that was recorded for the three months and nine months
ended September 30, 2007 represents federal alternative minimum tax. No federal income tax
provision was recorded for the three months and nine months ended September 30, 2006 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 September 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 FIN 48 nor
during the nine months ended September 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 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.
(14) 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.
During the third quarter of 2007, the Company sold a 25% interest in its future royalties from
PEG-INTRON for $92.5 million. Net of associated costs, the sale resulted in a gain of $88.7
million.
Contract Manufacturing - The Company provides contract manufacturing services for third
parties primarily MYOCET and Abelcet for export, each for Cephalon France, and the injectable
multivitamin, MVI, for Hospira, Inc.
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.
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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 tables present segment revenues and profitability information for the three- and
nine-month periods ended September 30, 2007 and 2006 (in thousands):
Three months ended September 30, | ||||||||||||||||||||||||
Contract | ||||||||||||||||||||||||
Segment | Products | Royalties | Manufacturing | Corporate(1) | Consolidated | |||||||||||||||||||
Revenues |
2007 | $ | 24,874 | $ | 18,206 | $ | 3,761 | $ | | $ | 46,841 | |||||||||||||
2006 | $ | 25,295 | $ | 18,705 | $ | 1,856 | $ | | $ | 45,856 | ||||||||||||||
Profit
(Loss)(2) |
2007 | $ | (1,545 | ) | $ | 106,872 | $ | 821 | $ | (16,631 | ) | $ | 89,517 | |||||||||||
2006 | $ | 6,526 | $ | 18,705 | $ | (1,025 | ) | $ | (21,841 | ) | $ | 2,365 |
Nine months ended September 30, | ||||||||||||||||||||||||
Contract | ||||||||||||||||||||||||
Segment | Products | Royalties | Manufacturing | Corporate(1) | Consolidated | |||||||||||||||||||
Revenues |
2007 | $ | 72,542 | $ | 52,840 | $ | 12,159 | $ | | $ | 137,541 | |||||||||||||
2006 | $ | 74,107 | $ | 53,889 | $ | 10,193 | $ | | $ | 138,189 | ||||||||||||||
Profit
(Loss)(2) |
2007 | $ | 2,481 | $ | 141,506 | $ | 2,675 | $ | (61,822 | ) | $ | 84,840 | ||||||||||||
2006 | $ | 19,586 | $ | 53,889 | $ | 1,690 | $ | (39,681 | ) | $ | 35,484 |
(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 before income tax
provision (in thousands):
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2007 | 2006 | 2007 | 2006 | |||||||||||||
Segment profit |
$ | 106,148 | $ | 24,206 | $ | 146,662 | $ | 75,165 | ||||||||
Unallocated operating expense |
15,531 | 23,573 | 57,038 | 53,028 | ||||||||||||
Operating income |
90,617 | 633 | 89,624 | 22,137 | ||||||||||||
Other corporate (expense) income |
(1,100 | ) | 1,732 | (4,784 | ) | 13,347 | ||||||||||
Income before income
tax provision |
$ | 89,517 | $ | 2,365 | $ | 84,840 | $ | 35,484 | ||||||||
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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 Nine Month Periods Ended September 30, 2007 and 2006
Overview
During the three months ended September 30, 2007, we sold a 25% interest in our future royalty
revenues on sales of PEG-INTRON. The gross proceeds were $92.5 million. The gain on the sale of
$88.7 million, after deducting related costs of the transaction, was recognized in full in our
Royalties segment in the third quarter of 2007. While product sales declined 2% from the
comparable three- and nine-month periods of 2006, cost of sales rose during the respective periods
due in part to higher amortization expense related to the license of the raw material used in the
production of Oncaspar and the expensing of validation batches in the first six months in
connection with the transfer of production to our Indianapolis facility. Total spending on
research and development rose from the comparable nine-month period although moderating during the
most recent three-month period. Restructuring costs incurred in 2007 and gains in 2006 on an
investment sale and refinancing of debt also affected period-over-period comparison. More detailed
analysis of each of these income and expense items is provided below.
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. The following is a reconciliation of segment profitability to consolidated income before
income tax (millions of dollars).
Three Months Ended | Nine Months Ended | |||||||||||||||
September | September | September | September | |||||||||||||
2007 | 2006 | 2007 | 2006 | |||||||||||||
Products
Segment (loss) profit(1) |
$ | (1.5 | ) | $ | 6.6 | $ | 2.5 | $ | 19.6 | |||||||
Royalties Segment profit |
106.9 | 18.7 | 141.5 | 53.9 | ||||||||||||
Contract Manufacturing
Segment profit (loss) |
0.8 | (1.1 | ) | 2.7 | 1.7 | |||||||||||
Corporate
and other
expenses(2) |
(16.7 | ) | (21.8 | ) | (61.9 | ) | (39.7 | ) | ||||||||
Income before income
tax provision |
$ | 89.5 | $ | 2.4 | $ | 84.8 | $ | 35.5 | ||||||||
(1) | Starting in the fourth quarter of 2006, we 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. | |
(2) | 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. |
17
Table of Contents
Products Segment
Products segment profitability (millions of dollars):
Three Months Ended | Nine Months Ended | |||||||||||||||||||||||
September | % | September | September | % | September | |||||||||||||||||||
2007 | Change | 2006 | 2007 | Change | 2006 | |||||||||||||||||||
Revenues |
$ | 24.8 | (2 | ) | $ | 25.3 | $ | 72.5 | (2 | ) | $ | 74.1 | ||||||||||||
Cost of sales |
11.2 | 21 | 9.2 | 31.4 | 18 | 26.5 | ||||||||||||||||||
Research and
development |
1.8 | (8 | ) | 2.0 | 8.0 | 87 | 4.3 | |||||||||||||||||
Selling and marketing |
7.7 | 5 | 7.3 | 23.3 | 1 | 23.1 | ||||||||||||||||||
Amortization of
acquired intangible
assets |
0.1 | (7 | ) | 0.2 | 0.5 | (3 | ) | 0.6 | ||||||||||||||||
Restructuring |
5.5 | n.m. | | 6.8 | n.m. | | ||||||||||||||||||
Segment (loss) profit |
$ | (1.5 | ) | n.m. | $ | 6.6 | $ | 2.5 | (87 | ) | $ | 19.6 | ||||||||||||
n.m. not meaningful |
Revenues
Sales performance of individual products is provided below (millions of dollars):
Three Months Ended | Nine Months Ended | |||||||||||||||||||||||
September | % | September | September | % | September | |||||||||||||||||||
Product | 2007 | Change | 2006 | 2007 | Change | 2006 | ||||||||||||||||||
Oncaspar |
$ | 10.5 | 42 | $ | 7.4 | $ | 27.7 | 29 | $ | 21.4 | ||||||||||||||
DepoCyt |
2.2 | 8 | 2.0 | 6.6 | 10 | 6.0 | ||||||||||||||||||
Abelcet |
6.7 | (25 | ) | 9.0 | 21.1 | (27 | ) | 28.8 | ||||||||||||||||
Adagen |
5.4 | (21 | ) | 6.9 | 17.1 | (4 | ) | 17.9 | ||||||||||||||||
Totals |
$ | 24.8 | (2 | ) | $ | 25.3 | $ | 72.5 | (2 | ) | $ | 74.1 | ||||||||||||
Oncaspar continues to demonstrate solid sales growth both for the quarter and the nine-month
period ended September 30, 2007, while Abelcet sales are down both on a quarterly as well as a
year-to-date basis leading to a 2% reduction in sales overall for both period comparisons.
Oncaspar volume growth was approximately 20% in the comparison of third-quarter 2007 to the
third quarter of 2006 and approximately 13% for the nine-month period comparisons. The U.S. Food
and Drug Administration (FDA) approved Oncaspar for the first-line treatment of patients with acute
lymphoblastic leukemia in July 2006. The increase in Oncaspar sales is attributable to an increase
in volume reflecting the continued transition to the first line use of Oncaspar and the adoption of
protocols in pediatrics and adult patients that call for dosage regimens that will include a
greater number of weeks of Oncaspar therapy and an April 1, 2007 price increase. 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. On April 1, 2007, we increased the price of these products which had a positive impact on
quarter and nine-month sales compared to prior periods. 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, continue to decline due to continued competition from
newer generation antifungal products coupled with some contraction of the overall intravenous
antifungal market. Abelcet declined 25% and 27% for the three- and nine-month periods ended
September 30, 2007, respectively when compared to the same periods in the preceding year. We
anticipate continued Abelcet competition.
Cost of sales
In the three months ended September 30, 2007, cost of products sold of $11.2 million as a
percentage of sales rose to 45% compared to 37% ($9.2 million) for the same period in the prior year.
This contributed to a corresponding nine-month period rise in cost of sales as a percentage of
sales from 36% of sales to 43%. The initiation of the transfer of production of Oncaspar and
Adagen from our South Plainfield facility to our Indianapolis facility 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, 2007 are unsaleable and were expensed as part of cost of sales. In addition,
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substantially higher supplier costs of materials for Adagen, negative production variances in
the third quarter for Abelcet and increased amortization expense associated with 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, dropped
slightly from $2.0 million in the third quarter of 2006 to $1.8 million in the third quarter of
2007 while increasing from $4.3 million to $8.0 million for the corresponding nine-month periods.
The year-to-date rise in product-related research and development expense was due to the 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 remained relatively unchanged from 2006
levels.
Amortization of acquired intangible assets
Amortization expense of $0.1 million for the three months ended September 30, 2007, and $0.5
million for the nine months ended September 30, 2007 was essentially 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.
All operations at our South Plainfield, New Jersey facility are expected to be transferred to
our Indianapolis facility 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
our Indianapolis facility and closure of the South Plainfield facility. Severance charges of $0.4
million and $1.7 million have been recognized in the quarter and year-to-date periods ended
September 30, 2007, respectively. We expect to incur other costs related to the relocation of
goods and equipment, and we will recognize such costs as incurred.
In the three months ended June 30, 2007, $1.9 million, the cost of validation batches at our
Indianapolis facility for both Oncaspar and Adagen, was expensed and included in cost of product
sales. There were no charges for validation batches during the third quarter of 2007. 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.
During the third quarter 2007, we modified our original product transfer and validation plan,
resulting in commencement of the decommission of certain assets earlier than originally expected at
the South Plainfield facility. These assets consist primarily of manufacturing equipment that will
not be transferred to the Indianapolis facility, nor will it continue to be used in manufacturing
at the South Plainfield facility. Accordingly, we fully recognized the remaining depreciation
totaling $5.1 million on these assets during the third quarter of 2007.
We may experience costs associated with lease termination or sublease of the South Plainfield
facility. Such costs will 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.
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Royalties Segment
Royalties segment profitability (millions of dollars):
Three Months Ended | Nine Months Ended | |||||||||||||||||||||||
September | % | September | September | % | September | |||||||||||||||||||
2007 | Change | 2006 | 2007 | Change | 2006 | |||||||||||||||||||
Royalty revenue |
$ | 18.2 | (3 | ) | $ | 18.7 | $ | 52.8 | (2 | ) | $ | 53.9 | ||||||||||||
Gain on sale of
royalty interest |
88.7 | n.m. | | 88.7 | n.m. | | ||||||||||||||||||
Segment profit |
$ | 106.9 | n.m. | $ | 18.7 | $ | 141.5 | n.m. | $ | 53.9 | ||||||||||||||
n.m. not meaningful |
Total royalty revenue of $18.2 million for the three months ended September 30, 2007 was 3%
lower than the $18.7 million during the comparable three-month period ended September 30, 2006.
Total royalties for the nine months ended September 30, 2007 decreased 2% to $52.8 million as
compared to $53.9 million during the comparable nine-month period ended September 30, 2006.
Growth in sales of PEG-INTRON, from which we derive the majority of our royalty revenue,
largely offset the effects of competition for Macugen in the U.S.
During the quarter ended September 30, 2007, we sold a 25% interest in future royalties
payable to us by Schering-Plough Corporation on net sales of PEG-INTRON occurring after June 30,
2007. The purchaser of the 25% interest, will be obligated to pay an additional $15.0 million to
us in the first quarter of 2012 if it receives a certain threshold level of royalties on sales of
PEG-INTRON occurring from July 1, 2007 through December 31, 2011. The gain on the sale of the
royalty interest, net of related costs, is $88.7 million. The $15.0 million contingent gain will
be recognized when and if the contingency is removed and collection is assured. As a result of the
sale, future royalties from PEG-INTRON are expected to be reduced by approximately 25%.
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
Contract manufacturing segment profitability (millions of dollars):
Three Months Ended | Nine Months Ended | |||||||||||||||||||||||
September | % | September | September | % | September | |||||||||||||||||||
2007 | Change | 2006 | 2007 | Change | 2006 | |||||||||||||||||||
Revenues |
$ | 3.8 | 103 | $ | 1.9 | $ | 12.2 | 19 | $ | 10.2 | ||||||||||||||
Cost of sales |
3.0 | 2 | 3.0 | 9.5 | 12 | 8.5 | ||||||||||||||||||
Segment profit |
$ | 0.8 | n.m. | $ | (1.1 | ) | $ | 2.7 | 58 | $ | 1.7 | |||||||||||||
n.m. not meaningful |
Revenues
Contract manufacturing revenue for the three- and nine-month periods ended September 30, 2007
was $3.8 million and $12.2 million, respectively. This compares to $1.9 million and $10.2 million
for the comparable periods of 2006. The increase in contract manufacturing revenue in the three
months ended September 30, 2007 was primarily attributable to the resolution, during the quarter
ended September 30, 2006 of an annual revenue reconciliation related to two contracts that resulted
in a reduction of revenue of $1.2 million. It is not uncommon for the timing of shipments to cause
quarter-over-quarter fluctuations.
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Cost of sales
Cost of sales for contract manufacturing fluctuates significantly from period to period
because of the nature of the business, the timing of production lots and the resultant levels of
cost absorption. Further complicating analysis in the three months ended September 30, 2006 was
the above-mentioned revenue reconciliation adjustment which lowered revenues of $1.2 million with
no corresponding reduction in cost of sales. This had approximately a three percentage point
adverse effect on cost of sales as a percent of sales for the nine months ended September 30, 2006.
Elevated costs in the first quarter of 2007 due to start-up of production related to a newly
negotiated agreement contributed to the higher nine-months 2007 cost of sales.
Non-U.S Revenue
During the three months ended September 30, 2007, we had export sales and royalties on export
sales of $20.0 million, of which $11.5 million were in Europe. This compares to $16.7 million of
export sales in the comparable three-month period of 2006, of which $9.2 million were in Europe.
We had export sales and royalties on export sales of $56.6 million and $34.0 million, of which
$48.6 million and $27.3 million were in Europe, for the nine months ended September 30, 2007 and
2006, respectively.
Corporate and Other Expense
(millions of dollars)
Three Months Ended | Nine Months Ended | |||||||||||||||||||||||
September | % | September | September | % | September | |||||||||||||||||||
2007 | Change | 2006 | 2007 | Change | 2006 | |||||||||||||||||||
Research and development |
$ | 9.0 | 4 | $ | 8.6 | $ | 33.8 | 48 | $ | 22.8 | ||||||||||||||
General and administrative |
6.6 | (6 | ) | 7.0 | 23.3 | 5 | 22.3 | |||||||||||||||||
Acquired in-process
research and development |
| n.m. | 8.0 | | n.m. | 8.0 | ||||||||||||||||||
Other (income) expense: |
||||||||||||||||||||||||
Investment income, net |
(2.7 | ) | (5 | ) | (2.8 | ) | (7.6 | ) | (65 | ) | (21.7 | ) | ||||||||||||
Interest expense |
4.3 | (28 | ) | 5.9 | 13.3 | (24 | ) | 17.4 | ||||||||||||||||
Other, net |
(0.5 | ) | (90 | ) | (4.9 | ) | (0.9 | ) | (90 | ) | (9.1 | ) | ||||||||||||
1.1 | n.m. | (1.8 | ) | 4.8 | n.m. | (13.4 | ) | |||||||||||||||||
Corporate and other
expenses |
$ | 16.7 | (24 | ) | $ | 21.8 | $ | 61.9 | 56 | $ | 39.7 | |||||||||||||
n.m. not meaningful |
Research and development
For the three months ended September 30, 2007, corporate research and development expenses
increased by $0.4 million to $9.0 million as compared to the three months ended September 30, 2006.
For the nine-month periods ended September 30, 2006 and 2007, research and development spending
increased from $22.8 million to $33.8 million, respectively. Included in the $33.8 million is $0.8
million related to milestones. 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. We anticipate that increased levels of research and development expense will continue.
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General and administrative
General and administrative expenses for the three- and nine-month periods ended September 30,
2007 of $6.6 million and $23.3 million, respectively, was relatively unchanged when compared to
$7.0 million and $22.3 million in the comparable periods in 2006. Certain legal and consulting
costs incurred in 2006 were not experienced this year, however, incremental share-based
compensation costs tended to offset these savings.
Acquired in-process research and development
In August 2006, we paid Santaris Pharma A/S $8.0 million for worldwide rights to develop and
commercialize certain RNA antagonists.
Other (income) expense
Other (income) expense for the three months ended September 30, 2007 was net expense of $1.1
million, as compared to net income of $1.8 million for the three months ended September 30, 2006.
For the nine-month periods, other (income) expense was net expense of $4.8 million in 2007 compared
to a net income of $13.4 million in 2006. Other (income) expense includes: net investment income,
interest expense and other, net.
Net investment income decreased by $0.1 million to $2.7 million for the three months ended
September 30, 2007 from $2.8 million for the three months ended September 30, 2006 due to more
investments outstanding in the comparative period ended September 30, 2006. Net investment income
decreased by $14.1 million to $7.6 million for the nine months ended September 30, 2007 from $21.7
million for the nine months ended September 30, 2006. The nine months decrease was principally
due to the sale in January and February 2006 of our remaining 1,023,302 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 $4.3 million and $13.3 million for the three-month and nine-month periods
ended September 30, 2007 and $5.9 million and $17.4 million for the three-month and nine-month
periods ended September 30, 2006, respectively. The reduction in interest expense is attributable
to the lowering of effective interest rates on our outstanding notes payable through a refinancing
during 2006. 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 repurchases of our 4.5% notes, including $40.7 million
principal amount during the nine months ended September 30, 2007, have taken place over the past
year and a half, reducing the outstanding balance as of September 30, 2007 to $81.9 million,
further contributing to savings of interest expense.
Other, net was a net income of $0.5 million for the three months ended September 30, 2007, as
compared to a net income of $4.9 million for the three months ended September 30, 2006. For the
nine months ended September 30, 2007, other, net was a net income of $0.9 million versus a net
income of $9.1 million for the nine months ended September 30, 2006. The change resulted primarily
from a $9.2 million gain on the repurchase of the 4.5% notes during the nine-month period.
Income Taxes
During the three and nine months ended September 30, 2007, we recorded a tax expense of
approximately $2.0 million and $2.1 million, respectively, which represents federal, state and
Canadian tax liabilities and includes an adjustment to taxes payable. During the three months and
nine months ended September 30, 2006, we recorded a tax expense of $0.1 million and $0.6 million,
respectively, representing state and Canadian taxes payable. A federal income tax provision was
recorded for the three months and nine months ended September 30, 2007 which represents federal
alternative minimum tax primarily related to the gain on sale of a royalty interest recognized in
the third quarter. No federal income tax provision was recorded for the three months and nine
months ended September 30, 2006 as the estimated annual effective tax rate was zero due to our
ability to utilize our federal net operating loss carryforwards to eliminate our projected taxable
income.
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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, restricted
investments and cash, and marketable securities, were $261.3 million as of September 30, 2007, as
compared to $240.6 million as of December 31, 2006. The increase is primarily due to the gain on
sale of an interest in future PEG-INTRON royalties reduced by the repurchase of a portion of our
notes payable as well as reductions in current liabilities. During the three months ended
September 30, 2007, we repurchased $24.8 million principal amount of our 4.5% notes bringing
year-to-date repurchases to $40.7 million. In addition, accounts payable and accrued expenses at
September 30, 2007 were approximately $30.1 million lower than at December 31, 2006. Those
liabilities at December 31, 2006 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 provided by operations totaled $91.8 million for the nine months ended September 30, 2007
compared to $29.6 million for the same period of 2006. This primarily reflects the
period-over-period increase in operating income ($89.6 million in 2007 compared to $22.1 million in
2006), adjusted for non-cash items ($23.7 million in 2007
compared to $13.4 million in 2006). A
net use of cash related to operating assets and liabilities of
approximately $15.6 million comprises the remainder of the period-to-period fluctuation.
Operating income rose for the nine months ended September 31, 2007 compared to the same period
of 2006 due primarily to the net gain on the sale of a future royalty interest of $88.7 million
offset in part by increased research and development spending, inclusive of acquired in-process
research and development, of $6.7 million and higher cost of product sales and contract
manufacturing of $5.8 million. The most significant fluctuation in operating assets and
liabilities was a reduction of accounts payable of $17.9 million.
Cash was used in investing activities in the nine months ended September 30, 2007 in the
amount of $59.5 million compared to $92.5 million in the nine-month period of 2006. In the
nine-month period ended September 30, 2007, maturities and proceeds from sale of marketable
securities totaling $288.9 million were used to purchase $315.6 million of marketable securities
resulting in a net decrease in cash of $26.7 million. In addition, during the nine-month period
ended September 30, 2007 we purchased property and equipment and product rights totaling $32.7
million.
The use of $40.2 million for the repurchase of $40.7 million principal amount of our 4.5%
notes payable during the nine months ended September 30, 2007 constituted our primary financing
activity. In addition, we received $0.4 million related to the exercise of employee stock options
and $0.4 million related to the employee stock purchase plan (ESPP) which had its first offering
period commence April 1, 2007.
As of September 30, 2007, we had $356.9 million of convertible notes outstanding. The 4.5%
notes in the principal amount of $81.9 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 nine-month
periods ended September 30, 2007 and September 30, 2006, there were payments of interest of $11.1
million and $17.2 million, respectively. Accrued interest on the aggregate amount of the notes
outstanding was $4.6 million as of September 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. As a result of the
sale in the third quarter of 2007, of a 25% interest in future royalties payable to us on sale of
PEG-INTRON occurring after June 30, 2007, cash flows from royalties earned will be affected
beginning in the fourth quarter of 2007. Based upon our current planned
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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. As indicated above, total cash
reserves include restricted investments and cash. These dedicated funds amounted to $82.2 million
at September 30, 2007 fully covering the $81.9 million principal amount of 4.5% notes payable July
1, 2008. While we believe that our current sources of liquidity will be adequate to satisfy our
capital and operational needs for the near future, we may enter into agreements with collaborators
with respect to the development and commercialization of products that could increase our cash
requirements, or seek additional financing to fund future operations and potential acquisitions.
We cannot assure you, however, that we will be able to obtain additional funds on acceptable terms,
if at all.
Off-Balance Sheet Arrangements
As part of our ongoing business, we do not participate in transactions that generate
relationships with unconsolidated entities or financial partnerships, such as entities often
referred to as structured finance or special purpose entities (SPE), which would have been
established for the purpose of facilitating off-balance sheet arrangements or other contractually
narrow limited purposes. As of September 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 $11.36 per share and 1.8 million restricted stock units were outstanding
at September 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.
During the nine-month period ended September 30, 2007 we repurchased $40.7 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 Obligations in our Annual Report on Form 10-K for
the year ended December 31, 2006.
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
September 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.
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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 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 September 30, 2007 and
December 31, 2006 (in thousands):
September 30, 2007 | December 31, 2006 | |||||||
Accounts Receivable Reductions |
||||||||
Chargebacks |
$ | 2,417 | $ | 3,388 | ||||
Cash Discounts |
152 | 168 | ||||||
Other (including returns) |
1,996 | 1,767 | ||||||
Total |
4,565 | 5,323 | ||||||
Accrued Liabilities |
||||||||
Medicaid Rebates |
924 | 1,335 | ||||||
Administrative Fees |
173 | 205 | ||||||
Total |
1,097 | 1,540 | ||||||
Grand Total |
$ | 5,662 | $ | 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
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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.
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.
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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 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. |
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| 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.
The table below presents the principal amounts and related weighted average interest rates of
our marketable debt securities, excluding primarily those related to our Executive Deferred Compensation
Plan, by year of maturity (twelve-month intervals ending September 30 of
the year indicated) as of September 30, 2007 (in thousands):
Maturities | ||||||||||||||||||||
Beyond | Amortized | |||||||||||||||||||
2008 | 2009 | Five Years | Cost | Fair Value | ||||||||||||||||
Fixed Rate |
$ | 139,833 | $ | 11,031 | $ | 3,000 | $ | 153,864 | $ | 153,774 | ||||||||||
Average Interest Rate |
4.80 | % | 5.23 | % | 5.50 | % | 4.85 | % | ||||||||||||
Variable Rate |
58,875 | | | 58,875 | 58,856 | |||||||||||||||
Average Interest Rate |
5.66 | % | 5.66 | % | ||||||||||||||||
$ | 198,708 | $ | 11,031 | $ | 3,000 | $ | 212,739 | $ | 212,630 | |||||||||||
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
September 30, 2007 are due June 1, 2013 and have a fair value of $301.5 million at September 30,
2007.
Our 4.5% convertible subordinated notes in the principal amount of $81.9 million are due July
1, 2008 and have a fair value of $80.1 million at September 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 September 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
September 30, 2007.
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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 5. Other Information
On
November 1, 2007, The Company restated its Executive Deferred Compensation Plan to make
certain definitional and technical clarifications to comply with Internal Revenue Code Section 409A
requirements. A copy of the restated plan is included as an exhibit to this Quarterly Report on
Form 10-Q.
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 | ) | |||
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
|
Executive Deferred Compensation Plan (2008 Restatement)** | * | ||||
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, 2007 filed on August 2, 2007. | |
(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: November 1, 2007 | By: | /s/Jeffrey H. Buchalter | ||
Jeffrey H. Buchalter | ||||
President and Chief Executive Officer (Principal Executive Officer) |
||||
Date: November 1, 2007 | By: | /s/Craig A. Tooman | ||
Craig A. Tooman | ||||
Executive Vice President, Finance and Chief Financial Officer (Principal Financial Officer) |
||||
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