ENZON PHARMACEUTICALS, INC. - Quarter Report: 2007 March (Form 10-Q)
Table of Contents
UNITED STATES 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 March 31, 2007
or
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Transition Period from to
Commission file number 0-12957
Enzon Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware (State of incorporation) |
22-2372868 (I.R.S. Employer Identification No.) |
|
685 Route 202/206, Bridgewater, New Jersey (Address of principal executive offices) |
08807 (Zip Code) |
(908) 541-8600
(Registrants telephone number, including area code)
(Registrants telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated
filer in Rule 12b-2 of the Exchange Act. (Check one):
Large Accelerated Filer o Accelerated Filer þ Non-Accelerated Filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
Shares of Common Stock outstanding as of May 2, 2007:
44,061,961.
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)
March 31, 2007 | December 31, 2006* | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 22,360 | $ | 28,431 | ||||
Short-term investments |
141,983 | 145,113 | ||||||
Accounts receivable, net of allowance for
doubtful accounts of $342 at March 31, 2007 and
$245 at December 31, 2006 |
13,264 | 15,259 | ||||||
Inventories |
20,900 | 17,618 | ||||||
Other current assets |
9,812 | 5,890 | ||||||
Total current assets |
208,319 | 212,311 | ||||||
Property and equipment, net of accumulated
depreciation of $27,896 at March 31, 2007 and
$26,506 at December 31, 2006 |
44,446 | 39,491 | ||||||
Marketable securities |
34,099 | 67,061 | ||||||
Amortizable intangible assets, net |
75,910 | 78,510 | ||||||
Other assets |
6,035 | 6,457 | ||||||
Total assets |
$ | 368,809 | $ | 403,830 | ||||
LIABILITIES AND STOCKHOLDERS DEFICIT |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 11,852 | $ | 24,918 | ||||
Accrued expenses |
16,086 | 34,967 | ||||||
Total current liabilities |
27,938 | 59,885 | ||||||
Notes payable |
393,642 | 397,642 | ||||||
Other liabilities |
2,711 | 2,744 | ||||||
Total liabilities |
424,291 | 460,271 | ||||||
Commitments and contingencies |
||||||||
Stockholders deficit: |
||||||||
Preferred stock $.01 par value, authorized
3,000,000 shares; no shares issued and
outstanding at March 31, 2007 and December
31, 2006 |
| | ||||||
Common stock $.01 par value, authorized
170,000,000 shares; issued and outstanding
44,061,961 shares at March 31, 2007
and 43,999,031 shares at December 31, 2006 |
441 | 440 | ||||||
Additional paid-in capital |
328,469 | 326,099 | ||||||
Accumulated other comprehensive income (loss) |
27 | (414 | ) | |||||
Accumulated deficit |
(384,419 | ) | (382,566 | ) | ||||
Total stockholders deficit |
(55,482 | ) | (56,441 | ) | ||||
Total liabilities and stockholders deficit |
$ | 368,809 | $ | 403,830 | ||||
* | Condensed from audited financial statements. |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
Table of Contents
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(Unaudited)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(Unaudited)
Three months ended | ||||||||
March 31, | ||||||||
2007 | 2006 | |||||||
Revenues: |
||||||||
Product sales, net |
$ | 22,649 | $ | 24,275 | ||||
Royalties |
16,344 | 17,248 | ||||||
Contract manufacturing |
2,495 | 3,206 | ||||||
Total revenues |
41,488 | 44,729 | ||||||
Costs and expenses: |
||||||||
Cost of product sales and contract manufacturing |
11,464 | 10,549 | ||||||
Research and development |
13,240 | 7,003 | ||||||
Selling, general and administrative |
16,190 | 15,838 | ||||||
Amortization of acquired intangible assets |
185 | 189 | ||||||
Restructuring charge |
569 | | ||||||
Total costs and expenses |
41,648 | 33,579 | ||||||
Operating (loss) income |
(160 | ) | 11,150 | |||||
Other income (expense): |
||||||||
Investment income, net |
2,577 | 15,816 | ||||||
Interest expense |
(4,553 | ) | (4,881 | ) | ||||
Other, net |
90 | (241 | ) | |||||
(1,886 | ) | 10,694 | ||||||
(Loss) income before income tax (benefit) provision |
(2,046 | ) | 21,844 | |||||
Income tax (benefit) provision |
(193 | ) | 136 | |||||
Net (loss) income |
$ | (1,853 | ) | $ | 21,708 | |||
(Loss) earnings per common share basic |
$ | (0.04 | ) | $ | 0.50 | |||
(Loss) earnings per common share diluted |
$ | (0.04 | ) | $ | 0.50 | |||
Weighted average shares basic |
43,862 | 43,524 | ||||||
Weighted average shares diluted |
43,862 | 43,524 | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
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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)
Three months ended | ||||||||
March 31, | ||||||||
2007 | 2006 | |||||||
Cash flows from operating activities: |
||||||||
Net (loss) income |
$ | (1,853 | ) | $ | 21,708 | |||
Adjustments to reconcile net (loss) income to net cash (used
in) provided by operating activities: |
||||||||
Depreciation and amortization |
3,997 | 3,292 | ||||||
Stock-based compensation |
2,084 | 898 | ||||||
Gain on sale of investments |
| (13,824 | ) | |||||
Amortization of debt issue costs |
438 | 448 | ||||||
Gain on redemption of notes payable |
(64 | ) | | |||||
Amortization
of debt securities premium/discount |
82 | 193 | ||||||
Changes in operating assets and liabilities |
(19,705 | ) | (9,206 | ) | ||||
Net cash (used in) provided by operating activities |
(15,021 | ) | 3,509 | |||||
Cash flows from investing activities: |
||||||||
Purchase of property and equipment |
(6,352 | ) | (1,319 | ) | ||||
Proceeds from sale of equity investment |
| 20,209 | ||||||
Purchase of product rights |
(17,500 | ) | (35,000 | ) | ||||
Proceeds from sale of marketable securities |
67,355 | 88,350 | ||||||
Purchase of marketable securities |
(90,695 | ) | (127,298 | ) | ||||
Maturities of marketable securities |
59,792 | | ||||||
Net cash provided by (used in) investing activities |
12,600 | (55,058 | ) | |||||
Cash flows from financing activities: |
||||||||
Redemption of notes payable |
(3,936 | ) | | |||||
Proceeds from exercise of common stock options |
286 | | ||||||
Net cash used in financing activities |
(3,650 | ) | | |||||
Net decrease in cash and cash equivalents |
(6,071 | ) | (51,549 | ) | ||||
Cash and cash equivalents at beginning of period |
28,431 | 76,497 | ||||||
Cash and cash equivalents at end of period |
$ | 22,360 | $ | 24,948 | ||||
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 Commissions Regulation S-X.
Accordingly, these financial statements do not include all of the information and footnotes
required for complete annual financial statements. The preparation of financial statements in
conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date
of the financial statements and the reported amounts of revenues and expenses during the reporting
period. In the opinion of management, all adjustments (consisting only of normal and recurring
adjustments) considered necessary for a fair presentation have been included. Certain prior year
amounts have been reclassified to conform to the current period presentation. Interim results are
not necessarily indicative of the results that may be expected for the year. The interim
consolidated financial statements should be read in conjunction with the consolidated financial
statements and the notes thereto included in the Companys Annual Report on Form 10-K for the year
ended December 31, 2006.
(2) Marketable Securities
The Company classifies its investments in marketable equity securities and debt securities,
including auction rate securities, as available-for-sale. The Company classifies those investments
with maturities of one year or less as current assets and investments in debt securities with
maturities greater than one year and marketable equity securities as noncurrent assets when it has
the intent and ability to hold such securities for at least one year. Debt and marketable equity
securities are carried at fair value, with the unrealized gains and losses (which are deemed to be
temporary), net of related tax effect, when appropriate, included in the determination of other
comprehensive income (loss) and reported in stockholders deficit. The fair value of all
securities is determined by quoted market prices.
The cost of the debt securities is adjusted for amortization of premiums and accretion of
discounts to maturity. The amortization and accretion, along with realized gains and losses, are
included in investment income, net. The cost of securities 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 March 31, 2007 and
December 31, 2006 were investments in state government bonds and corporate securities.
Other securities include investments of participants in the Companys Executive Deferred
Compensation Plan which are predominantly mutual fund shares totaling $1.7 million as of March 31,
2007 and $1.8 million as of December 31, 2006. As of December 31, 2006, these investments also included
$0.6 million of securities of government-sponsored entities (GSE). At any point in time, the assets of the deferred
compensation plan may also include cash ($0.8 million and $0.3 million at March 31, 2007 and
December 31, 2006, respectively). There is a non-current liability that offsets the aggregate
deferred compensation plan assets.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The amortized cost, gross unrealized holding gains or losses, and fair value of the Companys
available-for-sale securities by major security type at March 31, 2007 were as follows (in
thousands):
Gross | Gross | |||||||||||||||
Amortized | Unrealized | Unrealized | Fair | |||||||||||||
Cost | Holding Gains | Holding Losses | Value* | |||||||||||||
U.S. government and GSE debt |
$ | 27,003 | $ | | $ | (143 | ) | $ | 26,860 | |||||||
U.S. corporate debt |
127,930 | 5 | (157 | ) | 127,778 | |||||||||||
Auction rate securities |
19,475 | | | 19,475 | ||||||||||||
Other |
1,699 | 270 | | 1,969 | ||||||||||||
$ | 176,107 | $ | 275 | $ | (300 | ) | $ | 176,082 | ||||||||
* | $141,983 is included in short-term investments and $34,099 is included in marketable securities. |
The amortized cost, gross unrealized holding gains or losses,
and fair value of the Companys available-for-sale
securities by major security type at December 31, 2006 were as follows (in thousands):
Gross | Gross | |||||||||||||||
Amortized | Unrealized | Unrealized | Fair | |||||||||||||
Cost | Holding Gains | Holding Losses | 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 | ||||||||
* | Included in short-term investments $145,113 and marketable securities $67,061 at December 31, 2006. |
Maturities of marketable debt securities, excluding securities related to the Companys Executive
Deferred Compensation Plan, at March 31, 2007 were as follows (in thousands):
Twelve-Month | ||||||||
Periods Ending | Amortized | Fair | ||||||
March 31, | Cost | Value | ||||||
2008 |
$ | 141,992 | $ | 141,745 | ||||
2009 |
15,241 | 15,193 | ||||||
Maturities beyond five years |
17,175 | 17,175 | ||||||
$ | 174,408 | $ | 174,113 | |||||
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 March 31,
2007.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The following table shows the gross unrealized losses and fair values of the Companys
available-for-sale securities (both short-term and long-term) aggregated by investment category and
length of time that individual securities have been in a continuous loss position at March 31, 2007
(in thousands):
Less Than 12 Months | 12 Months or Greater | |||||||||||||||
Fair | Unrealized | Fair | Unrealized | |||||||||||||
Value | Loss | Value | Loss | |||||||||||||
U.S. government and GSE debt (1) |
$ | 3,995 | $ | (5 | ) | $ | 22,865 | $ | (138 | ) | ||||||
U.S. corporate debt (2) |
103,179 | (124 | ) | 8,260 | (33 | ) | ||||||||||
Total |
$ | 107,174 | $ | (129 | ) | $ | 31,125 | $ | (171 | ) | ||||||
(1) | U.S. government and government-sponsored enterprise (GSE) debt. The unrealized losses of $143,000 in the U.S. Government and GSE mortgage-backed securities were attributable to increases in interest rates. These holdings do not permit the issuer to settle the securities at a price less than the amortized cost. Further, because the declines in market value are due to increases in interest rates and not the credit quality of the issuer, and the Company has the ability and the intent to hold these investments until recovery of the cost, the Company does not consider its investments in U.S. Government and GSE debt to be other-than-temporarily impaired at March 31, 2007. | |
(2) | U.S. corporate debt. The unrealized losses of $157,000 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 March 31, 2007. |
(3) Comprehensive (Loss) Income
The following table reconciles net (loss) income to comprehensive (loss) income (in
thousands):
Three months ended March 31, | ||||||||
2007 | 2006 | |||||||
Net (loss) income |
$ | (1,853 | ) | $ | 21,708 | |||
Other comprehensive income: |
||||||||
Unrealized gain on securities
that arose during the period, net of tax (1) |
441 | 13,881 | ||||||
Reclassification adjustment
for gain included in net
(loss) income, net of tax(1) |
| (13,844 | ) | |||||
Total other comprehensive income |
441 | 37 | ||||||
Comprehensive (loss) income |
$ | (1,412 | ) | $ | 21,745 | |||
(1) | Information has not been tax-effected due to an estimated annual effective tax rate of zero. |
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(4) Earnings Per Common Share
Basic
(loss) earnings per common share is computed by dividing the net (loss) income available to
common stockholders, by the weighted average number of shares of common stock outstanding during
the period. Restricted stock awards and restricted stock units (collectively, nonvested shares)
are not considered to be outstanding shares until the service vesting period has been completed.
For purposes of calculating diluted (loss) earnings per common share, the denominator includes both
the weighted average number of shares of common stock outstanding and the number of common stock
equivalents if the inclusion of such common stock equivalents is dilutive. Dilutive common stock
equivalents potentially include non-qualified stock options, unvested restricted stock units and
restricted stock awards 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. The assumption is that the interest would not have been incurred if the notes
payable were converted into common stock.
The dilutive effect of stock options and nonvested shares takes into account a number of
treasury shares calculated using assumed proceeds, which includes compensation costs to be
attributed to future service and not yet recognized and, in the case of stock options, the cash
paid by the holders to exercise plus the excess, if any, of tax benefits that would be credited to
additional paid-in capital. For all affected reporting periods subsequent to the July 1, 2005
adoption of Financial Accounting Standards Board (FASB) Statement of Financial Accounting Standards
No. 123 (revised), Share-Based Payment (SFAS No. 123R), the inclusion of unrecognized share-based
compensation in the treasury stock component of the calculation caused stock options and nonvested
shares outstanding to be anti-dilutive and they were therefore excluded from the computation of
diluted earnings per share. In addition, for the three months ended
March 31, 2007, the Company reported a net loss.
For
the three-month periods ended March 31,
2007 and March 31, 2006, the Company determined that all potentially dilutive
common stock equivalents, (40.6 million and 12.7 million shares, respectively), were anti-dilutive.
Consequently, reported diluted (loss) earnings per common share is the same as the basic (loss)
earnings per common share amount.
(5) Share-Based Compensation
The Company accounts
for share-based compensation, including options and nonvested shares,
according to the provisions of SFAS No. 123R, Share-Based Payment. During the quarters ended
March 31, 2007 and 2006, the Company recognized share-based compensation expense of $2.1 million
and $0.9 million, respectively. Activity in options and nonvested shares during the quarter ended
March 31, 2007 and related balances outstanding as of that date are reflected below. The weighted
average grant price of the options granted was $8.57 per share and fair values ranged from $3.44 to
$3.61 per share for $7.1 million fair value in total during the
quarter ended March 31, 2007. The nonvested shares granted during the
quarter had a weighted average grant-date fair value of $8.56 per share.
Nonvested | ||||||||
Options | Shares | |||||||
Outstanding at December 31, 2006 |
6,708 | 1,458 | ||||||
Granted |
1,970 | 331 | ||||||
Exercised and vested |
(65 | ) | (7 | ) | ||||
Expired and forfeited |
(85 | ) | (23 | ) | ||||
Outstanding at March 31, 2007 |
8,528 | 1,759 | ||||||
Options vested and expected to vest at March 31, 2007 |
7,462 | |||||||
Options exercisable at March 31, 2007 |
4,835 | |||||||
As
of March 31, 2007, there was $9.6 million of total unrecognized compensation cost related to
unvested options that the Company expects to recognize over a weighted-average period of 29 months
and $13.4 million of total unrecognized compensation cost related to nonvested shares to be
recognized over a weighted-average period of 39 months.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(6) Inventories
As of March 31, 2007 and December 31, 2006 inventories consisted of the following (in
thousands):
March 31, 2007 | December 31, 2006 | |||||||
Raw materials |
$ | 8,296 | $ | 7,321 | ||||
Work in process |
6,335 | 4,444 | ||||||
Finished goods |
6,269 | 5,853 | ||||||
$ | 20,900 | $ | 17,618 | |||||
(7) Intangible Assets
As of March 31, 2007 and December 31, 2006 intangible assets consisted of the following (in
thousands):
Weighted | ||||||||||||
Average | ||||||||||||
Remaining | ||||||||||||
March 31, 2007 | December 31, 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 | 8 years | |||||||||
Patent |
1,875 | 1,875 | * | |||||||||
95,569 | 95,569 | 7 years | ||||||||||
Less: Accumulated amortization |
19,659 | 17,059 | ||||||||||
$ | 75,910 | $ | 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.
Amortization of intangibles amounted to $2.6 million for the quarter ended March 31, 2007 and
$2.0 million for the quarter ended March 31, 2006. Of these totals, $2.4 million and $1.8 million,
respectively, were classified as cost of product sales and contract manufacturing.
(8) Notes Payable
The table below reflects the composition of the notes payable balances as of March 31, 2007
and December 31, 2006 (in thousands):
March 31, 2007 | December 31, 2006 | |||||||
4.5% Convertible Subordinated Notes due July 1, 2008 |
$ | 118,642 | $ | 122,642 | ||||
4% Convertible Senior Notes due June 1, 2013 |
275,000 | 275,000 | ||||||
$ | 393,642 | $ | 397,642 | |||||
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The 4.5% notes mature on July 1, 2008 and are convertible, at the option of the holders, into
common stock of the Company at a conversion price of $70.98 per share at any time on or before July
1, 2008. The 4.5% notes are subordinated to all existing and future senior indebtedness. Upon
occurrence of a fundamental change, as defined in the indenture governing the notes, holders of
the notes may require the Company to redeem the notes at a price equal to 100% of the principal
amount plus accrued and unpaid interest. The Company may redeem any or all of the 4.5% notes at
specified redemption prices, plus accrued and unpaid interest to the day preceding the redemption
date.
The 4% notes mature on June 1, 2013, unless earlier redeemed, repurchased or converted, at the
option of the holders, into the Companys common stock at an initial conversion price of $9.55 per
share. The 4% notes are senior unsecured obligations and rank equal to other senior unsecured debt
of the Company and all future senior unsecured debt of the Company.
At any time on or after June 1, 2009, if the closing price of the Companys common stock for
at least 20 trading days in the 30-consecutive-trading-day period ending on the date one day prior
to the date of a notice of redemption is greater than 140% of the applicable conversion price on
the date of such notice, the Company, at its option, may redeem the 4% notes in whole or in part,
at a redemption price in cash equal to 100% of the principal amount of the 4% notes to be redeemed,
plus accrued and unpaid interest, if any, to the redemption date. The 4% notes are not redeemable
prior to June 1, 2009. Upon occurrence of a fundamental change, as defined in the indenture
governing the 4% notes, holders of the notes may require the Company to redeem the notes at a price
equal to 100% of the principal amount plus accrued and unpaid interest or, in certain cases, to
convert the notes at an increased conversion rate based on the price paid per share of the
Companys common stock in the transaction constituting the fundamental change.
In connection with the Companys second-quarter 2006 issuance of $275.0 million of the 4%
notes, the Company entered into a registration rights agreement whereby it agreed to file a shelf
registration statement with the U.S. Securities and Exchange Commission (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
$2.2 million being payable on the 4% notes as of March 31, 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 $1.3 million as of March 31, 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 March 31, 2007
accrued interest on the 4% notes amounted to $3.7 million and $1.0 million at December 31, 2006.
The
Company evaluates 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 feature should be classified as equity, and
therefore it does not need to be accounted for separately from the Convertible Notes. The Company
updates its analysis of the accounting for the conversion feature on a quarterly basis and more
frequently if circumstances warrant. If the conversion feature is required to be bifurcated in the
future, changes in the fair value of the conversion feature would be charged or credited to
interest expense in each period.
Effective
January 1, 2007, the Company
evaluates the accounting for the convertible notes in accordance with 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 and March 31, 2007.
(9) Restructuring
During the first quarter of 2007, the Company announced plans to consolidate manufacturing
operations in its Indianapolis, Indiana location. This action was taken as part of the Companys
continued efforts to streamline operations.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
As a result, all operations at the Companys South Plainfield, New Jersey facility are
expected to be transferred in 2008, resulting in the incurrence of certain restructuring and exit
costs. Among these costs will be employee severance and related benefits for affected employees in
an estimated range of approximately $4.0 million to $5.0 million all of which relate to the
Products segment. These amounts will be paid in 2008 upon the successful transfer of production to
Indianapolis and satisfactory performance by the affected employees
during the transition period. To date, a charge of
$569,000 has been recognized. Other costs are expected to be incurred relating to
relocation of goods and equipment and will be recognized as incurred.
In the aggregate, including employee costs, the
Company anticipates incurring costs in connection with this restructuring plan in the range of $8.0
million to $10.0 million.
In addition, the Company may experience costs associated with lease termination or sublease of
the South Plainfield facility of as much as $8.0 million. Such costs would be incurred and recognized when the Company ceases use of the property in 2008.
However, the Company does not know at this time what the final use or disposition of the leased
South Plainfield facility will be. There is also a possibility that
non-cash charges could be incurred related to asset impairments or
acceleration of depreciation, if
future triggering events occur. At March 31, 2007, the Companys analysis of
the future net undiscounted cash flows for the South Plainfield
facility assets did not indicate an impairment.
(10) Supplemental Cash Flow Information
The Company considers all highly liquid investment securities with original maturities of
three months or less to be cash equivalents. For each of the three month periods ended March 31,
2007 and 2006, there were payments of interest on the Companys notes payable of $2.8 million and
$8.9 million, respectively. Income tax payments for the three months ended March 31, 2007 and
2006, were $294,000 and $83,000, respectively.
(11) Income Taxes
During the
three months ended March 31, 2007, the Company recorded a net tax benefit of $193,000 which
represents state and Canadian tax liabilities and includes an adjustment to taxes payable. During the
three months ended March 31, 2006, the Company recognized a tax expense of $136,000 representing
state and Canadian tax liabilities. The Company did not recognize a U.S. Federal
income tax provision for these periods as the estimated annual effective tax rate is zero. As of
March 31, 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 of January 1, 2007, the Company had no tax positions relating to open income tax
returns that were considered to be uncertain. Accordingly, the Company had no liability for such
uncertain positions nor did it establish such a liability upon adoption of the interpretation.
The Company files income tax returns in the U.S. federal jurisdiction, and in various state
and foreign jurisdictions. With few exceptions, the Company is no longer subject to tax
examination by any of these tax authorities for years before 2000.
Interest and penalties, if any, related to unrecognized tax benefits, would be recognized as
income tax expense.
(12) Segment Information
The Company operates in the following business and reportable segments:
Products - Currently, the Company has developed or acquired four therapeutic, FDA-approved
products focused primarily in oncology and adjacent diseases. The Company currently markets its
products through its specialized U.S. sales forces that calls upon specialists in oncology,
hematology and other critical care disciplines. The Companys four proprietary marketed brands are
Oncaspar, Abelcet, Adagen and DepoCyt.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Royalties The Company derives licensing income from royalties received on the manufacture
and sale of products that utilize its proprietary technology. Royalties are primarily derived from
sales by Schering-Plough of PEG-INTRON. In addition to royalties from PEG-INTRON, the Company
receives royalty revenues on Pegasys and Macugen through an agreement with Nektar Therapeutics,
Inc. (Nektar) under which the Company shares in Nektars royalties on sales of these products.
Contract Manufacturing - The Company provides contract manufacturing services for third
parties primarily MYOCET and Abelcet for export, each for Cephalon, Inc., and the injectable
multivitamin, MVI, for Hospira, Inc.
Profit (loss) for the Companys segments is measured based on operating results, excluding
investment income, interest expense and income taxes. The Companys research and development
expense is considered a corporate expense until a product candidate enters Phase III clinical
trials at which time related costs would be chargeable to one of the Companys operating segments.
The Company does not identify or allocate property and equipment by operating segment, and does not
allocate depreciation to the operating segments. Operating segments do not have intersegment
revenue, and accordingly, there is none to be reported.
The following table presents segment revenues and profitability information for the
three-month periods ended March 31, 2007 and 2006 (in thousands):
Contract | ||||||||||||||||||||||||
Segment | Products | Royalties | Manufacturing | Corporate(1) | Consolidated | |||||||||||||||||||
Revenues |
2007 | $ | 22,649 | $ | 16,344 | $ | 2,495 | $ | | $ | 41,488 | |||||||||||||
2006 | $ | 24,275 | $ | 17,248 | $ | 3,206 | $ | | $ | 44,729 | ||||||||||||||
Profit (Loss)
(2) |
2007 | $ | 2,366 | $ | 16,344 | $ | 41 | $ | (20,797 | ) | $ | (2,046 | ) | |||||||||||
2006 | $ | 6,620 | $ | 17,248 | $ | 772 | $ | (2,796 | ) | $ | 21,844 |
(1) | Corporate expenses include operating (loss) income 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 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 (loss) to consolidated (loss) income before
income tax (benefit) provision (in thousands):
Three Months Ended March 31, | ||||||||
2007 | 2006 | |||||||
Segment profit |
$ | 18,751 | $ | 24,640 | ||||
Unallocated operating expense |
(18,911 | ) | (13,490 | ) | ||||
Operating income (loss) |
(160 | ) | 11,150 | |||||
Other corporate income and expense |
(1,886 | ) | 10,694 | |||||
(Loss) income before income tax
(benefit) provision |
$ | (2,046 | ) | $ | 21,844 | |||
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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 Months Ended March 31, 2007 and 2006
Overview
Total revenues declined $3.2 million or 7% in the first quarter of 2007 compared to the first
quarter of 2006 from $44.7 million to $41.5 million. Revenues were reduced in all three segments
leading to lower segment profits as well.
On a pretax basis,
income of $21.8 million reported in the quarter ended March 31, 2006 turned to a loss of
$2.1 million in the quarter ended March 31, 2007.
Spending on corporate-level research and development continued to rise as
previously anticipated leading to a rise in operating expenses. Period-to-period earnings
comparisons were further affected by the $13.8 million gain recognized in the first quarter of 2006
on the sale of our remaining interest in shares of common stock of Nektar Therapeutics, Inc. No
comparable investment gains were recognized in the first quarter of 2007.
Following is a reconciliation of segment profitability to consolidated income before income tax
(millions of dollars):
Three Months Ended | ||||||||||||
March | % | March | ||||||||||
2007 | Change | 2006 | ||||||||||
Products Segment profit |
$ | 2.4 | (64 | ) | $ | 6.6 | ||||||
Royalty Segment profit |
16.3 | (5 | ) | 17.2 | ||||||||
Contract Manufacturing Segment profit |
| (100 | ) | 0.8 | ||||||||
Corporate and other expenses* |
(20.8 | ) | n.m. | (2.8 | ) | |||||||
Income (loss) before income tax
provision (benefit) |
$ | (2.1 | ) | n.m. | $ | 21.8 | ||||||
* | 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, interest income, interest expense and income taxes. Research and development expense is considered a corporate expense unless it relates to an existing marketed product or a product candidate enters Phase III clinical trials at which time related costs would be chargeable to one of our operating segments. | |
n.m. not meaningful |
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Products Segment
Segment profitability (millions of dollars):
Three Months Ended | ||||||||||||
March | % | March | ||||||||||
2007 | Change | 2006 | ||||||||||
Revenues |
$ | 22.7 | (7 | ) | $ | 24.3 | ||||||
Cost of sales |
9.0 | 11 | 8.1 | |||||||||
Research and development |
2.4 | 91 | 1.3 | |||||||||
Selling and marketing |
8.1 | | 8.1 | |||||||||
Amortization of intangibles |
0.2 | (2 | ) | 0.2 | ||||||||
Restructuring |
0.6 | n.m. | | |||||||||
Segment profit |
$ | 2.4 | (64 | ) | $ | 6.6 | ||||||
n.m. not meaningful |
Revenues
Performance of individual products is provided below (millions of dollars):
Three Months Ended | |||||||||||||
March | % | March | |||||||||||
Product | 2007 | Change | 2006 | ||||||||||
Oncaspar |
$ | 7.5 | 16 | $ | 6.4 | ||||||||
DepoCyt |
2.4 | 14 | 2.1 | ||||||||||
Abelcet |
7.7 | (27 | ) | 10.5 | |||||||||
Adagen |
5.1 | (4 | ) | 5.3 | |||||||||
Totals |
$ | 22.7 | (7 | ) | $ | 24.3 | |||||||
Net product sales for the three months ended March 31, 2007 decreased by 7% to $22.7 million
compared to the same period of 2006 as growth in the oncology products, Oncaspar and DepoCyt, was
more than offset by declines in Abelcet.
The 16% increase in revenue for Oncaspar was related to its continued adoption in certain
protocols by hospitals and cooperative groups resulting in an increase in demand for the product.
The July 2006 approval by the U.S. Food and Drug Administration of Oncaspar for the first-line
treatment of patients with acute lymphoblastic leukemia has facilitated this trend. Sales of
DepoCyt, for treatment of lymphomatous meningitis, increased by 14% over the March 2006 quarter due
primarily to increased use by neuro-oncologists due of its more convenient dosing schedule,
however, we do experience quarter-to-quarter variability in the sales of this product. During the
three months ended March 31, 2007, U.S. and Canadian sales of Abelcet, our intravenous antifungal
product, were $7.7 million, which is 27% lower than in the first quarter of 2006, driven mainly by
declines in volume. Continuing competition for Abelcet from new therapeutics entering the market
had been anticipated. Sales of Adagen for the three months ended March 31, 2007 were largely
unchanged from the year-earlier period. Historically, quarterly sales of Adagen for treatment of
severe combined immuno-deficiency disease experience volatility because of the small number of
patients on therapy.
Cost of sales
Cost of sales of marketed
products for the three months ended March 31, 2007 was $9.0 million
or 40% of sales, compared to $8.1 million or 33% of sales for the comparable three-month period of
2006. The reduced margin earned in the period ended March 31, 2007 was due mainly to rising Adagen
costs resulting from production timing and lower production volumes. Oncaspar costs were slightly
higher as a percent of sales due, in part, to the amortization of the Oncaspar-related
intangible acquired in December 2006 to secure the supply of
L-asparaginase. DepoCyt and Abelcet costs remained
relatively constant as a percent of sales period-over-period.
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Research and development
Research and development spending on marketed products, primarily Oncaspar and Adagen,
increased 91 percent from $1.3 million in the first quarter of 2006 to $2.4 million in the first
quarter of 2007. The rise in product-related research and development expense was related to
ongoing formulation enhancement of Oncaspar and Adagen as well as Oncaspar life-cycle management.
Selling and marketing expenses
Selling and marketing expenses consist primarily of sales and marketing personnel, as well as
other commercial expense and marketing programs to support our sales force including medical
education. Selling and marketing expenses for the three months ended March 31, 2007 were
essentially unchanged from the three months ended March 31, 2006.
Amortization of acquired intangible assets
Amortization expense was $0.2 million for the three months ended March 31, 2007, unchanged
from the three months ended March 31, 2006. Amortization of intangible assets has been provided
over their estimated lives ranging from 1-14 years on a straight-line basis.
Restructuring
During the first quarter of 2007, we announced plans to consolidate manufacturing operations
in our Indianapolis, Indiana location. This action was taken as part of our continued efforts to
streamline operations.
As a result, all operations at our South Plainfield, New Jersey facility are expected to be
transferred in 2008, resulting in the incurrence of certain restructuring and exit costs. Among
these costs will be employee severance and related benefits for affected employees in an estimated
range of approximately $4.0 million to $5.0 million, all of which relate to the Products segment.
These amounts will be paid in 2008 upon the successful transfer of production to Indianapolis and
satisfactory performance by the affected employees during the
transition period. To date, a charge of $569,000 has been recognized. Other costs are expected to be incurred relating to relocation of
goods and equipment and will be recognized as incurred. In the
aggregate, including employee costs, we anticipate incurring
costs in connection with this restructuring plan in the range of $8.0 million to $10.0 million.
In addition, we may experience costs associated with lease termination or sublease of the
South Plainfield facility of as much as $8.0 million. Such costs
would be incurred and recognized when we cease use of the property in 2008. However, we do not
know at this time what the final use or disposition of the leased South Plainfield facility will
be. There is also a possibility that non-cash
charges could be incurred related to asset impairments or
acceleration of depreciation, if future triggering events occur. At
March 31, 2007, our analysis of the future net undiscounted
cash flows for the South Plainfield facility assets did not indicate
an impairment.
Royalties Segment
(millions of dollars)
Three Months Ended | ||||||||||||
March | % | March | ||||||||||
2007 | Change | 2006 | ||||||||||
Royalty revenue |
$ | 16.3 | (5) | $ | 17.2 | |||||||
Royalty revenue for the three months ended March 31, 2007 decreased 5% to $16.3 million as
compared to $17.2 million during the comparable three-month period ended March 31, 2006. The
reduction in royalties from the prior year period was due primarily to competition for Macugen in the
U.S., as expected. The majority of royalties is comprised of royalty revenue we receive on sales
of PEG-INTRON which remained relatively stable. We expect competition for PEG-INTRON combination
therapy in Japan later this year.
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Costs and expenses
Current, royalty revenues do not require any material specific maintenance costs. At some
point in the future, costs associated with initiation of new outlicensing agreements that could
result in our receipt of a royalty stream and, if necessary, costs necessary to maintain the
underlying technology may be charged to the Royalties segment.
Contract Manufacturing Segment
(millions of dollars)
Three Months Ended | ||||||||||||
March | % | March | ||||||||||
2007 | Change | 2006 | ||||||||||
Revenues |
$ | 2.5 | (22) | $ | 3.2 | |||||||
Cost of sales |
2.5 | 1 | 2.4 | |||||||||
Segment profit |
$ | | (100) | $ | 0.8 | |||||||
Revenues
Contract manufacturing revenue for the three months ended March 31, 2007 was $2.5 million.
This compares to $3.2 million for the comparable period of 2006. The decrease in contract
manufacturing revenue was primarily attributable to the timing of shipments to our customers.
Cost of sales
Cost of sales for contract manufacturing for the three months ended March 31, 2007 at $2.5
million effectively offset sales for the period due principally to certain start-up production
costs related to a newly negotiated agreement. This compared to $2.4 million or 75% of sales for the comparable three-month period of
2005.
Non-U.S Revenue
During the three months
ended March 31, 2007, we had export sales and royalties on export
sales of $15.6 million, of which $8.8 million were in Europe. This compares to $15.8 million of
export sales in the comparable three-month period of 2006, of which $8.5 million were in
Europe.
Corporate and Other Expense
(millions of dollars)
Three Months Ended | ||||||||||||
March | % | March | ||||||||||
2007 | Change | 2006 | ||||||||||
Research and development |
$ | 10.8 | 89 | $ | 5.7 | |||||||
General and administrative |
8.1 | 5 | 7.7 | |||||||||
Other (income) expense: |
||||||||||||
Investment
income, net |
(2.6 | ) | (84) | (15.8 | ) | |||||||
Interest expense |
4.6 | (7) | 4.9 | |||||||||
Other, net |
(0.1 | ) | n.m. | 0.3 | ||||||||
1.9 | n.m. | (10.6 | ) | |||||||||
Corporate and other expenses |
$ | 20.8 | n.m. | $ | 2.8 | |||||||
n.m. not meaningful |
Research and development. For the three months ended March 31, 2007, research and development
expenses increased by $5.1 million to $10.8 million as compared to the three months ended March 31,
2006. As we have previously indicated, we are significantly expanding our research and development
efforts in areas such as rhMBL, PEG-SN38, the HIF-1 alpha antagonist
and other LNA - and PEGylation
- based programs. This has resulted in hiring of new positions and associated costs. We
anticipate that increased levels of research and development expense will continue. In addition,
milestone payments to third parties for the successful advancement of our research and development
pipeline are expected to total as much as $10.0 million in 2007.
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General and
administrative. The slight increase in general and administrative expense was
partially attributable to the share-based compensation expense of
options and non-vested shares, the
effects of which are incurred in increments over the related vesting periods.
Other (income) expense. Other (income) expense for the three months ended March 31, 2007 was
net expense of $1.9 million, as compared to net income of $10.6 million for the three months ended
March 31, 2006. Other (income) expense includes: net investment income, interest expense and other
income or expense.
Net investment income declined by $13.2 million to $2.6 million for the three months ended
March 31, 2007 compared with $15.8 million for the three months ended March 31, 2006. The decrease
was principally due to the sale in January and February 2006 of our remaining shares of Nektar
Therapeutics, Inc. common stock which resulted in a net gain of $13.8 million and cash proceeds of
$20.2 million with no comparable gain in the current three-month period.
Interest expense was $4.6 million for the three months ended March 31, 2007 and $4.9 million
for the three months ended March 31, 2006 reflecting the improved interest rate mix.
Other, net
expense changed from $0.3 million expense to a $0.1 million income between the
first quarter of 2006 and 2007, respectively, due in part to small gain resulting from the purchase of
$4.0 million of outstanding convertible 4.5% notes payable at a discount to par. This gain was
partially offset by the partial write-off of the existing debt offering costs.
Income taxes
During the
three months ended March 31, 2007, we recorded a net tax benefit of $193,000 which
represents state and Canadian tax liabilities and includes an adjustment to taxes payable. No U.S.
income tax provision was recorded for the three months ended March 31, 2007 as the estimated annual
effective tax rate is zero due to the uncertainty around our ability to utilize our net operating
loss carryforwards. During the three months ended March 31, 2006, we recognized a tax expense of
$136,000 representing state and Canadian tax liabilities.
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 we will be able to sustain a position taken on an income tax return. Upon adoption of FIN 48
as of January 1, 2007, we had no tax positions relating to open income tax returns that we
considered to be uncertain. Accordingly, we had no liability for such uncertain positions nor did
we establish such a liability upon adoption of the interpretation.
We file income tax returns in the U.S. federal jurisdiction, and in various state and foreign
jurisdictions. With few exceptions, we are no longer subject to tax examination by any of these
tax authorities for years before 2000.
Interest and penalties, if any, related to unrecognized tax benefits, would be recognized as income
tax expense.
Liquidity and Capital Resources
Total cash reserves, which include cash, cash equivalents, short-term investments and
marketable securities, were $198.4 million as of March 31, 2007, as compared to $240.6 million as
of December 31, 2006. We invest our excess cash primarily in United States government-backed
securities and investment-grade corporate debt securities and auction rate securities.
Cash used in
operating activities totaled $15.0 million for the three months ended March 31,
2007 compared to cash provided by operating activities of $3.5 million for the three months ended
March 31, 2006. Operating income recognized in the first quarter of 2006 of $11.1 million turned
to a near break-even in the first quarter of 2007 due in large part to lower revenues and increased
research and development spending. Also contributing to cash used in operations in the three
months ended March 31, 2007, versus the comparable prior-year period were increases in inventories
to preferred levels and reductions in accounts payable.
Investing
activities yielded a $12.6 million source of cash in the first quarter of 2007
versus a $55.1 million use of cash a year earlier. Maturities of certain marketable securities
were not reinvested and served to fund the operating cash needs
during the three months ended March 31, 2007. In addition, in February 2007, we made
a $17.5 million payment for a license related to our
December 2006 agreement
17
Table of Contents
with Ovation
Pharmaceuticals, Inc. related to Oncaspar production. This payment had been recorded as an accrued
liability as of December 31, 2006.
Redemption of $4.0 million principal amount of the 4.5% notes payable during the first quarter
of 2007 was the primary financing cash outflow.
As of March 31, 2007, we had outstanding $275.0 million of convertible senior notes payable
that bear interest at an annual rate of 4% and $118.6 million of convertible subordinated notes
payable that bear interest at an annual rate of 4.5%. Interest is payable on June 1 and December 1
for the 4% notes and January 1 and July 1 for the 4.5% notes. Accrued interest on the notes was
$5.0 million and $3.7 million, respectively as of March 31, 2007 and December 31, 2006.
Our current sources of liquidity are our cash reserves; interest earned on such cash reserves;
product sales; royalties earned, which are primarily
related to sales of PEG-INTRON; and contract manufacturing revenue. Based upon our currently
planned research and development activities and related costs and our current sources of liquidity,
we anticipate our current cash reserves and expected cash flow from operations will be sufficient
to meet our capital and operational requirements for the near future; however, we may refinance or
seek new financing prior to the maturity of our convertible
subordinated 4.5% notes in 2008.
While we believe that our current sources of liquidity will be adequate to satisfy our capital
and operational needs for the coming twelve months, we are evaluating numerous alternatives for obtaining
additional financing, including possible future offerings of equity or debt securities or
agreements with collaborators with respect to the development and commercialization of products, to
fund future operations and potential acquisitions. We cannot assure you, however, that we will be
able to obtain additional funds on acceptable terms, if at all.
Off-Balance Sheet Arrangements
As part of our ongoing business, we do not participate in transactions that generate
relationships with unconsolidated entities or financial partnerships, such as entities often
referred to as structured finance or special purpose entities (SPE), which would have been
established for the purpose of facilitating off-balance sheet arrangements or other contractually
narrow limited purposes. As of March 31, 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 $11.48 per share and 1.6 million restricted stock units were outstanding
at March 31, 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 three months ended March 31, 2007, we made payments of
$5.0 million relating to the milestone for filing the HIF-1
alpha antagonist IND, $17.5 million to Ovation to
secure the long-term supply of L-asparaginase, and $7.0 million for related legal services associated with
the new supply agreement.
Other
than as disclosed above, there have been no 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.
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Our consolidated financial statements are presented in accordance with accounting principles
that are generally accepted in the United States. All professional accounting standards effective
as of March 31, 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
significant because changes to certain judgments and assumptions inherent in these policies could
affect our consolidated financial statements.
We base our estimates, to the extent possible, on historical experience. Historical
information is modified as appropriate based on current business factors and various assumptions
that we believe are necessary to form a basis for making judgments about the carrying value of
assets and liabilities. We evaluate our estimates on an ongoing basis and make changes when
necessary. Actual results could differ from our estimates.
Revenues
Revenues from product sales and contract manufacturing revenue are recognized when title
passes to the customer, generally at the time of shipment. 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 and returns 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 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 changes. 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 Medicaid 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.
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The following is a summary of reductions of gross sales accrued as of March 31, 2007 and
December 31, 2006 (in thousands):
March 31, 2007 | December 31, 2006 | |||||||
Accounts Receivable Reductions |
||||||||
Chargebacks |
$ | 2,787 | $ | 3,388 | ||||
Cash discounts |
155 | 168 | ||||||
Other (including returns) |
1,919 | 1,767 | ||||||
Total |
4,861 | 5,323 | ||||||
Accrued liabilities |
||||||||
Medicaid rebates |
855 | 1,335 | ||||||
Administrative fees |
200 | 205 | ||||||
Total |
1,055 | 1,540 | ||||||
Grand Total |
$ | 5,916 | $ | 6,863 | ||||
Royalties under our license agreements with third parties are recognized when reasonably
determinable and earned through the sale of the product by the licensee net of future credits,
chargebacks, sales discount rebates and refunds and collection is reasonably assured. Notification
from the third-party licensee of the royalties earned under the license agreement is the basis for
royalty revenue recognition. This information is generally received from the licensees in the
quarter subsequent to the period in which the sales occur.
Non-refundable milestone payments that represent the completion of a separate earnings process
are recognized as revenue when earned, upon the occurrence of contract-specified events and when
the milestone has substance. Non-refundable payments received upon entering into license and other
collaborative agreements where we have continuing involvement are recorded as deferred revenue and
recognized ratably over the estimated service period.
Income Taxes
Under the asset and liability method of Financial Accounting Standards Board (FASB) Statement
of Financial Accounting Standards 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), 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.
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.
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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. Until we have developed sufficient reliable Enzon-specific information, we are using
relevant industry data for purposes of estimating forfeitures of share-based payments. In the near
term, as more stratified data come available, rates will be adjusted using blended information. We
have elected the modified prospective transition method for SFAS No. 123R 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.
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, the risk free interest rate, and dividends, if any. Expected
volatility is based on historical Enzon stock price information.
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.
On
May 2, 2007, a FASB Staff Position amended FIN 48 to provide guidance on how an enterprise should determine
whether a tax position is effectively settled for the purpose of recognizing previously
unrecognized tax benefits. This guidance, which is effective immediately, had no impact on our
consolidated financial statements as of and for the three month period ended March 31, 2007.
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. |
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| The risk that there will be a decline in sales of one or more of our marketed products or products sold by others from which we derive royalty revenues. Such sales declines could result from increased competition, loss of patent protection, pricing, supply shortages and/or regulatory constraints. | ||
| The risk that we will be unable to obtain critical compounds used in the manufacture of our products at economically feasible prices or at all, or one of our key suppliers will experience manufacturing problems or delays. | ||
| Decisions by regulatory authorities regarding whether and when to approve our regulatory applications as well as their decisions regarding labeling and other matters could affect the commercial potential of our products or developmental products. | ||
| The risk that we will fail to obtain adequate financing to meet our future capital and financing needs. | ||
| The risk that key personnel will leave the Company. |
A more detailed discussion of these and other factors that could affect 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 undertake no
duty to update this information.
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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 are also exposed to the risks of changes in
the credit quality of issuers. We typically invest the majority of our investments in the
shorter-end of the maturity spectrum.
The table
below presents the principal amounts and related weighted-average
interest rates of our marketable debt securities, excluding those
related to our Executive Deferred Compensation Plan, by
year of maturity (twelve-month intervals ending March 31 of the year indicated) as of March 31, 2007 (in thousands):
Maturities | ||||||||||||||||||||
Beyond | ||||||||||||||||||||
2008 | 2009 | Five Years | Total | Fair Value | ||||||||||||||||
Fixed Rate |
$ | 116,940 | $ | 10,941 | $ | | $ | 127,881 | $ | 127,670 | ||||||||||
Average Interest Rate |
4.88 | % | 4.42 | % | | 4.85 | % | |||||||||||||
Variable rate |
25,052 | 4,300 | 17,175 | 46,527 | 46,443 | |||||||||||||||
Average interest rate |
4.55 | % | 4.42 | % | 5.27 | % | 4.80 | % | ||||||||||||
$ | 141,992 | $ | 15,241 | $ | 17,175 | $ | 174,408 | $ | 174,113 | |||||||||||
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 March
31, 2007 are due June 1, 2013 and have a fair value of $292.9 million at March 31, 2007.
Our 4.5%
convertible subordinated notes in the principal amount of
$118.6 million are due July 1,
2008 and have a fair value of $116.7 million at March 31, 2007.
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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 March 31, 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
March 31, 2007.
Changes in Internal Controls
There were no changes in our internal controls over financial reporting, as such term is
defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during the period covered by this
report that have materially affected, or are reasonably likely to materially affect our internal
control over financial reporting.
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Part II OTHER INFORMATION
Item 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 By-laws | (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
|
Amended and Restated Employment Agreement with Jeffrey H. Buchalter dated April 27, 2007** | * | ||||||
10.2
|
2007 Outside Director Compensation Plan** | * | ||||||
31.1
|
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | * | ||||||
31.2
|
Certification of Principal Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | * | ||||||
32.1
|
Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | * | ||||||
32.2
|
Certification of Principal Accounting Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | * |
* | Filed herewith. | |
** | Management contracts or compensatory plans and arrangements required to be filed pursuant to Item 601(b)(10)(ii)(A) or (iii) of Regulation S-K. | |
Referenced exhibit was previously filed with the Commission as an exhibit to the Companys filing indicated below and is incorporated herein by reference to that filing: | ||
(1) | Current Report on Form 8-K filed May 19, 2006. | |
(2) | Quarterly Report on Form 10-Q for the quarter ended June 30, 2006 filed on August 3, 2006. | |
(3) | Form 8-A12G (File No. 000-12957) filed with the Commission on May 22, 2002. | |
(4) | Form 8-A12G/A (File No. 000-12957) filed with the Commission on February 20, 2003. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ENZON PHARMACEUTICALS, INC. (Registrant) |
||||
By: | /s/ Jeffrey H. Buchalter | |||
Jeffrey H. Buchalter | ||||
President and Chief Executive Officer (Principal Executive Officer) |
||||
Date: May 4, 2007 | By: | /s/ Craig A. Tooman | ||
Craig A. Tooman | ||||
Executive Vice President, Finance
and Chief Financial Officer (Principal Financial Officer) |
||||
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