ENZON PHARMACEUTICALS, INC. - Quarter Report: 2008 June (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2008
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) |
||
Not Applicable (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, a non-accelerated filer or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o | Accelerated filer þ | Non-accelerated filer o (Do not check if a smaller reporting company) |
Smaller reporting company 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 August 6, 2008: 44,876,173.
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)
June 30, 2008 | December 31, 2007* | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 65,426 | $ | 40,053 | ||||
Short-term investments |
53,866 | 123,907 | ||||||
Restricted investments and cash |
14,561 | 73,592 | ||||||
Accounts receivable, net of allowance for doubtful accounts of
$735 at June 30, 2008 and $280 at December 31, 2007 |
17,039 | 14,927 | ||||||
Inventories |
20,044 | 22,297 | ||||||
Other current assets |
6,272 | 6,401 | ||||||
Total current assets |
177,208 | 281,177 | ||||||
Property and equipment, net of accumulated depreciation of
$41,419 at June 30, 2008 and $37,031 at December 31, 2007 |
45,012 | 45,312 | ||||||
Marketable securities |
72,045 | 20,653 | ||||||
Amortizable intangible assets, net |
66,077 | 68,141 | ||||||
Other assets |
4,523 | 5,074 | ||||||
Total assets |
$ | 364,865 | $ | 420,357 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 7,298 | $ | 9,441 | ||||
Notes payable |
12,521 | 72,391 | ||||||
Accrued expenses |
25,413 | 23,650 | ||||||
Total current liabilities |
45,232 | 105,482 | ||||||
Notes payable |
275,000 | 275,000 | ||||||
Other liabilities |
3,807 | 3,302 | ||||||
Total liabilities |
324,039 | 383,784 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity: |
||||||||
Preferred stock $.01 par value, authorized 3,000,000 shares;
no shares issued and outstanding at June 30, 2008 and
December 31, 2007 |
| | ||||||
Common stock $.01 par value, authorized 170,000,000 shares;
issued and outstanding 44,840,399 shares and 44,199,831
shares
at June 30, 2008 and December 31, 2007, respectively |
448 | 442 | ||||||
Additional paid-in capital |
340,481 | 335,318 | ||||||
Accumulated other comprehensive (loss) income |
(361 | ) | 326 | |||||
Accumulated deficit |
(299,742 | ) | (299,513 | ) | ||||
Total stockholders equity |
40,826 | 36,573 | ||||||
Total liabilities and stockholders equity |
$ | 364,865 | $ | 420,357 | ||||
* | 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
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 | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
Revenues: |
||||||||||||||||
Product sales, net |
$ | 29,206 | $ | 25,019 | $ | 56,635 | $ | 47,668 | ||||||||
Royalties |
15,035 | 18,290 | 29,735 | 34,634 | ||||||||||||
Contract manufacturing |
6,723 | 5,903 | 13,367 | 8,398 | ||||||||||||
Total revenues |
50,964 | 49,212 | 99,737 | 90,700 | ||||||||||||
Costs and expenses: |
||||||||||||||||
Cost of product sales and contract manufacturing |
17,406 | 15,269 | 33,545 | 26,733 | ||||||||||||
Research and development |
14,056 | 16,921 | 26,835 | 29,993 | ||||||||||||
Selling, general and administrative |
18,070 | 15,982 | 33,868 | 33,273 | ||||||||||||
Amortization of acquired intangible assets |
166 | 185 | 333 | 370 | ||||||||||||
Restructuring charge |
889 | 755 | 2,143 | 1,324 | ||||||||||||
Total costs and expenses |
50,587 | 49,112 | 96,724 | 91,693 | ||||||||||||
Operating income (loss) |
377 | 100 | 3,013 | (993 | ) | |||||||||||
Other income (expense): |
||||||||||||||||
Investment income, net |
1,120 | 2,366 | 3,299 | 4,943 | ||||||||||||
Interest expense |
(3,181 | ) | (4,491 | ) | (6,566 | ) | (9,044 | ) | ||||||||
Other, net |
24 | 327 | 320 | 417 | ||||||||||||
(2,037 | ) | (1,798 | ) | (2,947 | ) | (3,684 | ) | |||||||||
(Loss) income before income tax provision |
(1,660 | ) | (1,698 | ) | 66 | (4,677 | ) | |||||||||
Income tax provision |
85 | 261 | 295 | 68 | ||||||||||||
Net loss |
$ | (1,745 | ) | $ | (1,959 | ) | $ | (229 | ) | $ | (4,745 | ) | ||||
Loss per common share basic |
$ | (0.04 | ) | $ | (0.04 | ) | $ | (0.01 | ) | $ | (0.11 | ) | ||||
Loss per common share diluted |
$ | (0.04 | ) | $ | (0.04 | ) | $ | (0.01 | ) | $ | (0.11 | ) | ||||
Weighted average shares basic |
44,352 | 43,884 | 44,259 | 43,873 | ||||||||||||
Weighted average shares diluted |
44,352 | 43,884 | 44,259 | 43,873 | ||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
Table of Contents
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Six months ended | ||||||||
June 30, | ||||||||
2008 | 2007 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (229 | ) | $ | (4,745 | ) | ||
Adjustments to reconcile net loss to net cash
provided by (used in) operating activities: |
||||||||
Depreciation and amortization |
10,833 | 8,106 | ||||||
Write-down
of manufacturing assets |
619 | | ||||||
Share-based compensation |
4,338 | 4,477 | ||||||
Loss on impairment of securities available for sale |
645 | | ||||||
Gain on redemption of notes payable |
(371 | ) | (198 | ) | ||||
Write off and amortization of debt issue costs |
715 | 904 | ||||||
Amortization
of debt securities premium/discount |
(2,510 | ) | 132 | |||||
Changes in operating assets and liabilities |
(4,802 | ) | (18,515 | ) | ||||
Net cash provided by (used in) operating
activities |
9,238 | (9,839 | ) | |||||
Cash flows from investing activities: |
||||||||
Purchase of property and equipment |
(4,088 | ) | (11,564 | ) | ||||
Purchase of product rights |
| (17,500 | ) | |||||
Proceeds from sale of marketable securities |
50,240 | 110,850 | ||||||
Purchase of marketable securities |
(94,482 | ) | (164,488 | ) | ||||
Maturities of marketable securities |
123,100 | 103,492 | ||||||
Net cash provided by investing activities |
74,770 | 20,790 | ||||||
Cash flows from financing activities: |
||||||||
Proceeds from exercise of common stock options |
983 | 339 | ||||||
Proceeds from employee stock purchase plan |
581 | 226 | ||||||
Issuance of
shares pursuant to employee stock purchase plan |
(700 | ) | | |||||
Redemption of notes payable |
(59,499 | ) | (15,723 | ) | ||||
Net cash used in financing activities |
(58,635 | ) | (15,158 | ) | ||||
Net increase (decrease) in cash and cash equivalents |
25,373 | (4,207 | ) | |||||
Cash and cash equivalents at beginning of period |
40,053 | 28,431 | ||||||
Cash and cash equivalents at end of period |
$ | 65,426 | $ | 24,224 | ||||
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. Research and development and general and administrative expense have been
corrected by immaterial amounts for the three months and six months ended June 30, 2007 and the
three months ended March 31, 2008. Certain patent-related legal costs were reclassified reducing
research and development expense and increasing general and administrative expense by: $818,000 for
the three months ended June 30, 2007, $986,000 six months ended June 30, 2007 and $405,000 for the
three months ended March 31, 2008. There was no net effect from these reclassifications on
earnings, financial position or cash flows.
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, 2007.
(2) Spin-Off of Research and Development Operations
On May 7, 2008, the Company announced that the Board of Directors has authorized a plan to
spin-off its biotechnology activities in a transaction that will result in two independent public
companies. The newly independent biotechnology business will be engaged in research and
development based on Enzons PEGylation and the Locked Nucleic
Acid technologies, among others, to develop therapeutics for cancer
and other life-threatening diseases. Enzon plans to contribute $100.0 million
in cash and $50.0 million in the form of an interest-bearing term note, as well as certain operating assets and
liabilities to the newly created company. Enzon will retain the
currently marketed products,
Oncaspar, DepoCyt, Adagen and Abelcet, the rights to current and future royalty revenues from
existing licenses, including PEG-INTRON, Pegasys, Macugen, Cimzia and
Hematide, certain deferred tax assets, including net operating loss
carryforwards and its
manufacturing facility in Indianapolis, Indiana. Enzons outstanding convertible notes will remain
an obligation of Enzon. Completion of the spin-off is subject to numerous conditions, including
final approval by the Board of Directors and the effectiveness of a registration
statement with the Securities and Exchange Commission. It is expected that the taxable spin-off
will be completed in the fourth quarter of 2008.
Through June 30, 2008, $1.1 million of transaction costs have been incurred related to the
spin-off. These charges have been expensed as incurred and are included in Selling, General and
Administrative expense. Total costs by the time of the spin-off are estimated to be approximately
$8.0 million to $10.0 million.
(3) New Accounting Standards
Effective January 1, 2008, the Company adopted the provisions related to financial assets and
liabilities of Statement of Financial Accounting Standards No. 157, Fair Value Measurements,
(SFAS No. 157), as amended. SFAS No. 157 provides guidance on the use of fair value in accounting
and disclosure for assets and liabilities when such accounting and disclosure is called for by
other accounting literature. As amended by Financial Accounting Standards Board (FASB) Staff
Position (FSP) 157-2, the applicability of SFAS No. 157 for most nonfinancial assets and
nonfinancial liabilities has been delayed to 2009 for calendar-year companies.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Enzon currently has no financial assets or liabilities for which it recognizes in earnings
periodic gains or losses resulting from fair value fluctuations. Short-term investments and
marketable securities are carried at fair value on the consolidated balance sheets with temporary
gains and losses reflected in other comprehensive income. The
Company has no significant nonfinancial assets or liabilities that it expects will be affected in 2009 when SFAS
No. 157 becomes fully effective.
The Company also adopted, as of January 1, 2008, SFAS No. 159, The Fair Value Option for
Financial Assets and Financial Liabilities and Emerging Issues Task Force consensus No. 07-3 (EITF
07-3), Accounting for Advance Payments for Goods and Services to Be Used in Future Research and
Development Activities. SFAS No. 159 permits companies to measure many financial assets and
liabilities at fair value on a contract-by-contract basis in order to prevent distortions in
earnings in the event certain other instruments in the balance sheet are marked-to-market through
earnings. EITF 07-3 calls for capitalization of non-refundable advance payments to acquire goods
or pay for services that will be consumed or performed in future periods in conducting research and
development activities and to amortize them over the period of expected benefit. The Companys
adoption of SFAS No. 159 and EITF 07-3 did not have an impact on its financial statements.
(4) Investments and Marketable Securities
The Company classifies its investments in debt and equity securities as either short-term or
long-term based upon their stated maturities and the Companys intent and ability to hold them.
Investments with stated maturities of one year or less are classified as current assets.
Investments in debt securities with stated 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.
The cost of 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.
Investments in marketable equity securities and debt securities, including auction rate
securities are classified as available-for-sale. 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
and reported in stockholders equity.
Fair value is determined in accordance with SFAS No. 157, which established a hierarchy of
preferred measures based upon the level of market observability used in determining the
investments fair value. The preferred level is that which is derived from readily available
quoted prices in active markets (Level 1). As the table below indicates, the majority of the
Companys investments and marketable securities are valued based
on Level 1 inputs. Recently, due to instability
in the financial markets, failed auctions for a certain auction rate security have occurred and, as
a result, the Company has had to seek alternative measures of fair value which were deemed to be
Level 2.
The table below indicates the fair value measurements employed as of June 30, 2008 (in
thousands):
Quoted Prices | ||||||||||||
in Active | Significant | |||||||||||
Markets for | Unobservable | |||||||||||
Identical Assets | Inputs | |||||||||||
(Level 1) | (Level 2) | Total | ||||||||||
U.S. corporate debt |
$ | 117,998 | $ | | $ | 117,998 | ||||||
Auction rate securities |
4,650 | 855 | 5,505 | |||||||||
Other |
2,408 | | 2,408 | |||||||||
$ | 125,056 | $ | 855 | $ | 125,911 | |||||||
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The majority of the auction rate securities are rated AAA or AA and are variable-rate debt
instruments for which interest rates are reset approximately every 28 days. The underlying
securities have contractual maturities that are long-term, but because of the historical ability to
liquidate holdings at the time of the periodic auctions, they have been classified as short-term,
available-for-sale securities. Refer to the analysis of unrealized losses below regarding the
impairment of auction rate 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 June 30, 2008 were as follows (in
thousands):
Gross | Gross | |||||||||||||||
Amortized | Unrealized | Unrealized | Fair | |||||||||||||
Cost | Holding Gains | Holding Losses | Value* | |||||||||||||
U.S. corporate debt |
$ | 118,852 | $ | 103 | $ | (957 | ) | $ | 117,998 | |||||||
Auction rate securities |
5,505 | | | 5,505 | ||||||||||||
Other |
2,143 | 342 | (77 | ) | 2,408 | |||||||||||
$ | 126,500 | $ | 445 | $ | (1,034 | ) | $ | 125,911 | ||||||||
* | Includes short-term investments of $53,866 and marketable securities of $72,045 at June 30, 2008. |
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, 2007 were as follows (in
thousands):
Gross | Gross | |||||||||||||||
Amortized | Unrealized | Unrealized | Fair | |||||||||||||
Cost | Holding Gains | Holding Losses | Value* | |||||||||||||
U.S. Government and GSE debt |
$ | 9,796 | $ | 2 | $ | (19 | ) | $ | 9,779 | |||||||
U.S. corporate debt |
136,037 | 83 | (97 | ) | 136,023 | |||||||||||
Auction rate securities |
51,375 | | (240 | ) | 51,135 | |||||||||||
Other |
2,308 | 333 | | 2,641 | ||||||||||||
$ | 199,516 | $ | 418 | $ | (356 | ) | $ | 199,578 | ||||||||
* | Includes short-term investments of $123,907, restricted investments of $55,018 and marketable securities of $20,653 at December 31, 2007. |
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 due July 1, 2008. As
of June 30, 2008, all restricted investments had been liquidated leaving only restricted cash
amounting to $14.6 million. In July 2008, the Company paid off the remaining $12.5 million due on
its 4.5% notes according to their terms. Amounts remaining in restricted cash after settlement of
the 4.5% notes will be returned to the Companys unrestricted cash accounts to be used for general
corporate purposes. As of December 31, 2007, restricted investments amounted to $55.0 million of
which $29.0 million was held in auction rate securities and restricted cash amounted to $18.6
million.
Other securities include investments of participants in the Companys Executive Deferred
Compensation Plan (predominantly mutual fund shares) totaling $2.1 million as of June 30, 2008 and
$2.3 million as of December 31, 2007. The assets of the deferred compensation plan also include
cash ($1.4 million and $0.6 million at June 30, 2008 and December 31, 2007, respectively). There
is a non-current liability that offsets the aggregate deferred compensation plan assets. In
addition, other securities included $0.3 million of corporate equity securities as of June 30, 2008
and December 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)
Maturities of marketable debt securities, excluding securities related to the Companys
Executive Deferred Compensation Plan, at June 30, 2008 were as follows (in thousands):
Twelve-Month | |||||||||
Periods Ending | Amortized | Fair | |||||||
June 30, | Cost | Value | |||||||
2009 |
$ | 53,595 | $ | 53,524 | |||||
2010 |
58,225 | 57,574 | |||||||
2011 |
12,537 | 12,405 | |||||||
$ | 124,357 | $ | 123,503 | ||||||
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 one investment in auction rate securities at risk with an
original cost basis of $1.5 million. Beginning in the latter portion of 2007, there have been no
successful auctions for this security and the credit rating of the issuer was downgraded in June
2008. Based upon the foregoing, the Company has concluded that the decline in estimated fair value
(Level 2) of $645,000 is other than temporary. An impairment write-down to the securitys
estimated fair value at June 30, 2008 of $855,000 was recognized in investment income in the
statement of operations for the three months ended June 30, 2008. The Company has determined that,
of the remaining unrealized holding losses in its marketable securities and short-term investments,
none were other than temporary as of June 30, 2008.
The following table shows the gross unrealized losses and fair values of the Companys
available-for-sale securities (both short-term and long-term) aggregated by investment category and
length of time that individual securities have been in a continuous loss position at June 30, 2008
(in thousands):
Less Than 12 Months | 12 Months or Greater | |||||||||||||||
Fair | Unrealized | Fair | Unrealized | |||||||||||||
Value | Loss | Value | Loss | |||||||||||||
U.S. corporate debt (1) |
$ | 91,285 | $ | (957 | ) | $ | | $ | | |||||||
Other(2) |
2,066 | (77 | ) | | | |||||||||||
Total |
$ | 93,351 | $ | (1,034 | ) | $ | | $ | | |||||||
(1) | U.S. corporate debt. The unrealized losses of $957,000 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 June 30, 2008. | |
(2) | The Companys investments in other securities relate to the Companys Executive Deferred Compensation Plan. |
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(5) Comprehensive Loss
The following table reconciles net loss to comprehensive loss (in thousands):
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
Net loss |
$ | (1,745 | ) | $ | (1,959 | ) | $ | (229 | ) | $ | (4,745 | ) | ||||
Other comprehensive (loss) income: |
||||||||||||||||
Unrealized (loss) gain on securities
that arose during the period(1) |
(1,251 | ) | 227 | (1,332 | ) | 668 | ||||||||||
Reclassification adjustment
for impairment loss included in net loss(1) |
645 | | 645 | | ||||||||||||
Total other comprehensive (loss) income |
(606 | ) | 227 | (687 | ) | 668 | ||||||||||
Comprehensive loss |
$ | (2,351 | ) | $ | (1,732 | ) | $ | (916 | ) | $ | (4,077 | ) | ||||
(1) | Information has not been tax-effected due to an estimated annual effective tax rate of zero. |
(6) Earnings Per Common Share
Basic earnings (loss) per common share is computed by dividing the net income (loss) 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 (loss) per common share, the denominator includes both
the weighted average number of shares of common stock outstanding and the number of common stock
equivalents if the inclusion of such common stock equivalents is dilutive. Dilutive common stock
equivalents potentially include non-qualified stock options, nonvested shares, shares issuable
under the employee stock purchase plan (ESPP) and the number of shares issuable upon conversion of
the Companys convertible subordinated notes payable and/or convertible senior notes payable. In
the case of notes payable, the diluted earnings per share calculation is further affected by an
add-back of interest to the numerator under the assumption that the interest would not have been
incurred if the notes payable were converted into common stock.
The dilutive effect of stock options and nonvested shares takes into account a number of
treasury shares calculated using assumed proceeds, which includes share-based compensation costs to
be attributed to future service and not yet recognized and, in the case of stock options, the cash
paid by the holders to exercise plus the excess, if any, of tax benefits that would be credited to
additional paid-in capital.
Any potentially dilutive shares were excluded from the computation of diluted loss per common
share for all periods presented, as the effect on net loss per share was antidilutive.
Consequently, reported diluted loss per common share is the same as basic loss per common share in
each of these periods. For the three months ended June 30, 2008 and 2007, potentially dilutive
common stock equivalents were 39.8 million and 40.4 million shares, respectively. For the
six-month periods ended June 30, 2008 and 2007, potentially dilutive common stock equivalents were
39.8 million and 40.4 million, respectively.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(7) 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 Statement of Financial Accounting
Standards No. 123 (revised), Share-Based Payment (SFAS No. 123R).
Stock Option and Nonvested Share Awards
During the three-month periods ended June 30, 2008 and 2007, the Company recognized
share-based compensation expense of $2.1 million and $1.5 million, respectively, relating to stock
option and nonvested share awards. During the six-month periods ended June 30, 2008 and 2007, the
Company recognized share-based compensation expense of $4.2 million and $4.5 million, respectively,
for these plans. The weighted average grant price of the options granted was $9.22 per share and
fair values ranged from $3.27 to $3.53 per share. The fair value of
the options granted during the six months
ended June 30, 2008 was $0.7 million. The nonvested shares granted during the six months had a
weighted average grant-date fair value of $9.28 per share for an
aggregated fair value of $4.0 million. The Company uses historical data to
estimate forfeiture rates. Activity in options and nonvested shares during the six-months ended
June 30, 2008 and related balances outstanding as of that date are reflected below (in thousands).
Nonvested | ||||||||
Options | Shares | |||||||
Outstanding at January 1, 2008 |
8,385 | 1,774 | ||||||
Granted |
200 | 432 | ||||||
Exercised and vested |
(40 | ) | (215 | ) | ||||
Expired and forfeited |
(40 | ) | (45 | ) | ||||
Outstanding at June 30, 2008 |
8,505 | 1,946 | ||||||
Options vested and expected to vest at June 30, 2008 |
7,813 | |||||||
Options exercisable at June 30, 2008 |
5,980 | |||||||
As of June 30, 2008, there was $7.3 million of total unrecognized compensation cost related to
unvested options that the Company expects to recognize over a weighted-average period of 19 months
and $11.3 million of total unrecognized compensation cost related to nonvested shares expected to
be recognized over a weighted-average period of 25 months.
Employee Stock Purchase Plan
For the quarter and six months ended June 30, 2008, compensation expense recognized for the
ESPP was $0.2 million which was recorded in the same expense categories in the interim consolidated
statement of operations as the underlying employee compensation. For
the quarter and six months ended June 30, 2007, ESPP
compensation expense was $0.1 million. 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. Issuance of shares under the
ESPP during the six months ended June 30, 2008 amounted to 72,201 shares.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(8) Inventories
As of June 30, 2008 and December 31, 2007 inventories consisted of the following (in
thousands):
June 30, 2008 | December 31, 2007 | |||||||
Raw materials |
$ | 9,737 | $ | 9,809 | ||||
Work in process |
6,312 | 5,419 | ||||||
Finished goods |
3,995 | 7,069 | ||||||
$ | 20,044 | $ | 22,297 | |||||
(9) Intangible Assets
As of June 30, 2008 and December 31, 2007 intangible assets consisted of the following (in
thousands):
Weighted | ||||||||||||
Average | ||||||||||||
June 30, | December 31, | Remaining | ||||||||||
2008 | 2007 | Useful Lives | ||||||||||
Product acquisition costs |
$ | 83,694 | $ | 78,694 | 6.1 years | |||||||
Product patented technology |
6,000 | 6,000 | 6.5 years | |||||||||
Manufacturing patent |
9,000 | 9,000 | 6.5 years | |||||||||
Patent |
1,875 | 1,875 | * | |||||||||
100,569 | 95,569 | |||||||||||
Less:
Accumulated amortization |
34,492 | 27,428 | ||||||||||
$ | 66,077 | $ | 68,141 | |||||||||
* | fully amortized |
During the quarter ended June 30, 2008, the Company recognized a $5.0 million liability due to
Sanofi-Aventis related to its license of rights to market and distribute Oncaspar in the U.S. The
license agreement, effective in January 2006, called for this incremental payment upon achievement
of a specified level of Oncaspar sales. The threshold sales level is expected to be met in the
third quarter of 2008 and the incremental payment is payable to Sanofi-Aventis in January 2009.
Amortization
of intangibles amounted to $4.4 million for the three months ended June 30, 2008
and $2.6 million for the three months ended June 30, 2007.
Amortization for the three months ended June 30, 2008 includes $1.9 million amortization of the newly recognized Oncaspar-related license rights. This
adjusts the carrying amount of the intangible asset to recognize benefit derived from the payment
over the term of the agreement. The remaining $3.1 million will
be amortized over the remaining six-year term. Of the amounts recognized in each of the three-month periods, $4.3
million and $2.4 million were charged to cost of product sales and contract manufacturing for the
periods ended June 30, 2008 and 2007, respectively. For the six-months ended June 30, 2008 and
June 30, 2007, amortization charges were $7.1 million and
$5.2 million, respectively, with $6.7
million and $4.8 million, respectively, classified as 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)
(10) Notes Payable
The table below reflects the composition of the notes payable balances as of June 30, 2008 and
December 31, 2007 (in thousands):
June 30, 2008 | December 31, 2007 | |||||||
Current |
||||||||
4.5% Convertible Subordinated Notes due
July 1, 2008 |
$ | 12,521 | $ | 72,391 | ||||
Long-Term |
||||||||
4% Convertible Senior Notes due June 1, 2013 |
$ | 275,000 | $ | 275,000 | ||||
The 4.5% notes matured on July 1, 2008 and were repaid in full plus accrued and unpaid
interest.
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 percent 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 percent of the principal amount of the 4% notes
to be redeemed, plus accrued and unpaid interest, if any, to the redemption date. The 4% notes are
not redeemable prior to June 1, 2009. Upon occurrence of a fundamental change, as defined in the
indenture governing the 4% notes, holders of the notes may require the Company to redeem the notes
at a price equal to 100% of the principal amount plus accrued and unpaid interest or, in certain
cases, to convert the notes at an increased conversion rate based on the price paid per share of
the Companys common stock in the transaction constituting the fundamental change.
In connection with the Companys second-quarter 2006 issuance of $275.0 million of the 4%
notes, the Company entered into a registration rights agreement whereby it agreed to file a shelf
registration statement with the SEC to permit the registered resale of the 4% notes and the common
stock issuable upon conversion of the notes. The shelf registration was filed in a timely manner
on October 2, 2006 and was declared effective by the SEC on November 3, 2006. Failure to maintain
the effectiveness of the registration statement for a period of two years beginning November 3,
2006 would result in additional interest of up to $0.5 million being payable on the 4% notes as of
June 30, 2008. No amounts are owed, nor have any been recorded, for failure to maintain the
effectiveness of the registration statement.
Interest
on the 4.5% notes is payable on January 1 and July 1 of each year. Accrued interest on
the 4.5% notes was $282,000 as of June 30, 2008 and $1.6 million as of December 31, 2007. Interest
on the 4% notes is payable on June 1 and December 1 of each year. As of June 30, 2008 accrued
interest on the 4% notes amounted to $1.0 million, unchanged from December 31, 2007.
The Company evaluates the accounting for the conversion feature 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. If a conversion feature is required to be
bifurcated in the future, changes in the fair value of the conversion feature would be included in
operations in each period. The Company concluded that no beneficial conversion feature existed at
the inception of the notes.
(11) 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)
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. Severance costs recognized in the three-month
and six-month periods ended June 30, 2008 were $0.5 million
and $1.5 million, respectively. In the three-month and six-month
periods ended June 30, 2007, the severance costs were
$0.7 million and $1.3 million, respectively. These amounts are being paid in 2008 in connection with the successful
transfer of production to the Companys Indianapolis facility and closure of the South Plainfield
facility.
During 2007, the Company recognized $0.4 million of employee severance and related benefits
when it combined its previous two specialized sales forces into one sales team.
The Company incurred the following costs in connection with its restructuring programs during
the six months ended June 30, 2008 and from inception of the manufacturing restructuring through
December 31, 2007 (in thousands):
Six Months | ||||||||||||
Ended | Year Ended | |||||||||||
June 30, 2008 | December 31, 2007 | Total | ||||||||||
Employee termination costs manufacturing |
$ | 1,524 | $ | 2,232 | $ | 3,756 | ||||||
sales forces |
| 385 | 385 | |||||||||
1,524 | 2,617 | 4,141 | ||||||||||
Write-down of manufacturing assets |
619 | 5,124 | 5,743 | |||||||||
$ | 2,143 | $ | 7,741 | $ | 9,884 | |||||||
The amounts for employee termination benefits are reflected in accrued expenses.
Payments have commenced and are expected to continue for several months relating to the
manufacturing restructuring. Payments in connection with the sales force restructuring have ended.
Payments to terminated employees have
amounted to $0.9 million during the six months ended
June 30, 2008, leaving an accrued liability as of June 30, 2008 of $3.2 million.
In addition to the restructuring charges described above, costs incurred during 2007 related
to validation batches at the Indianapolis facility for Oncaspar and Adagen, were expensed and
included in cost of product sales in the amount of $1.9 million.
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.
(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 six-month periods ended June 30, 2008
and 2007, there were payments of interest on the Companys notes
payable of $7.2 million and $8.5 million, respectively. Income tax payments for the six months ended June 30, 2008 and 2007, were
$1.9 million and $0.5 million, respectively.
During
the six months ended June 30, 2008, the Company accrued a
liability of $5.0 million for an incremental payment to
Sanofi-Aventis in the first quarter of 2009 for achievement of an
specified level of Oncaspar sales. The liability
and asset were recognized based upon the probability that a contractual milestone would be achieved
in the third quarter of 2008.
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ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(13) Income Taxes
During the three months and six months ended June 30, 2008, the Company recorded a net tax
expense of $0.1 million and $0.3 million, respectively which represents Canadian tax liabilities.
During the three months and six months ended June 30, 2007, the Company recorded a net tax expense
of $0.3 million and $0.1 million representing state and Canadian tax liabilities as well as an
adjustment to taxes payable. 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 June 30, 2008, 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.
(14) Segment Information
The Company operates in the following business and reportable segments:
Products The Products segment performs the manufacturing, development, marketing and selling
of pharmaceutical products for patients with cancer or other life-threatening diseases. Currently,
the Company has developed or acquired four therapeutic products approved by the U.S. Food and Drug
Administration focused primarily in oncology and other life-threatening diseases. The Company
currently markets its products through its specialized U.S. sales force that calls upon specialists
in oncology, hematology, infectious disease and other critical care disciplines. The Companys
four proprietary marketed brands are Oncaspar, DepoCyt, Abelcet and Adagen.
Royalties The Company receives royalties on the manufacture and sale of products that
utilize its proprietary technology. Royalty revenues are currently derived from sales of products
that use the Companys PEGylation platform, namely PEG-INTRON marketed by Schering-Plough, Macugen
marketed by OSI Pharmaceuticals, Inc. and Pfizer Inc., and Pegasys marketed by Hoffmann-La Roche.
Through an agreement with Nektar, the Company shares in Nektars royalties on sales of Pegasys and
Macugen which utilize Enzon technology.
Contract Manufacturing The Company manufactures products for third parties. It manufactures
for Cephalon, Abelcet for export and MYOCET. It also produces the injectable multivitamin,
MVI®, for Hospira, Inc. In addition, the Company has negotiated two contracts to
produce clinical product for other companies.
The performance of each of the Companys segments is monitored by the Companys chief
operating decision maker, the President and Chief Executive Officer. Segment profit (loss) 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-month and six-month periods ended June 30, 2008 and 2007 (in thousands):
Three months ended June 30, | ||||||||||||||||||||||||
Contract | ||||||||||||||||||||||||
Segment | Products | Royalties | Manufacturing | Corporate(1) | Consolidated | |||||||||||||||||||
Revenues |
2008 | $ | 29,206 | $ | 15,035 | $ | 6,723 | $ | | $ | 50,964 | |||||||||||||
2007 | $ | 25,019 | $ | 18,290 | $ | 5,903 | $ | | $ | 49,212 | ||||||||||||||
Profit (Loss) |
2008 | $ | 4,189 | $ | 15,035 | $ | 2,868 | $ | (23,752 | ) | $ | (1,660 | ) | |||||||||||
2007 | $ | 1,822 | $ | 18,290 | $ | 1,813 | $ | (23,623 | ) | $ | (1,698 | ) |
Six months ended June 30, | ||||||||||||||||||||||||
Contract | ||||||||||||||||||||||||
Segment | Products | Royalties | Manufacturing | Corporate(1) | Consolidated | |||||||||||||||||||
Revenues |
2008 | $ | 56,635 | $ | 29,735 | $ | 13,367 | $ | | $ | 99,737 | |||||||||||||
2007 | $ | 47,668 | $ | 34,634 | $ | 8,398 | $ | | $ | 90,700 | ||||||||||||||
Profit (Loss) |
2008 | $ | 7,275 | $ | 29,735 | $ | 4,978 | $ | (41,922 | ) | $ | 66 | ||||||||||||
2007 | $ | 4,202 | $ | 34,634 | $ | 1,854 | $ | (45,367 | ) | $ | (4,677 | ) |
(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. |
Following is a reconciliation of segment profit to consolidated (loss) income before income
tax provision (in thousands):
Three Months Ended June 30 | Six Months Ended June 30, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
Segment profit |
$ | 22,092 | $ | 21,925 | $ | 41,988 | $ | 40,690 | ||||||||
Unallocated operating expense |
(21,715 | ) | (21,825 | ) | (38,975 | ) | (41,683 | ) | ||||||||
Operating income (loss) |
377 | 100 | 3,013 | (993 | ) | |||||||||||
Other corporate expense |
(2,037 | ) | (1,798 | ) | (2,947 | ) | (3,684 | ) | ||||||||
(Loss) income before income
tax provision |
$ | (1,660 | ) | $ | (1,698 | ) | $ | 66 | $ | (4,677 | ) | |||||
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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 important medicines for patients with cancer and other life-threatening
conditions. We operate in three business segments: Products, Royalties and Contract
Manufacturing. We have a portfolio of four marketed products, Oncaspar, DepoCyt, Abelcet and
Adagen. Our drug development programs utilize several cutting-edge technologies, including our
PEGylation Customized Linker TechnologyTM and the LNA, or Locked Nucleic Acid,
technology, to create product candidates with benefits such as reduced dosing frequency and less
toxicity. Our PEGylation technology was used to develop two of our products, Oncaspar and Adagen,
and has created a royalty revenue stream from licensing partnerships for other products developed
using the technology. Enzon also engages in contract manufacturing opportunities for several
pharmaceutical companies to broaden the Companys revenue base.
On May 7, 2008, the Company announced that the Board of Directors has
authorized a plan to spin-off its biotechnology activities in a transaction
that will result in two independent public companies. The newly independent
biotechnology business will be engaged in research and development based on
Enzons PEGylation and the Locked Nucleic Acid technologies, among others, to
develop therapeutics for cancer and other life-threatening diseases. Enzon
plans to contribute $100.0 million in cash and $50.0 million in the form of an
interest-bearing term note as well as certain operating assets and liabilities
to the newly created company. Enzon will retain the currently marketed
products, Oncaspar, DepoCyt, Adagen and Abelcet, the rights to current and
future royalty revenues from existing licenses, including PEG-INTRON, Pegasys,
Macugen, Cimzia and Hematide, certain deferred tax assets, including net
operating loss carryforwards and its manufacturing facility in Indianapolis,
Indiana. Enzons outstanding convertible notes will remain an obligation of
Enzon. Completion of the spin-off is subject to numerous conditions, including
final approval by the Board of Directors and the effectiveness of a
registration statement with the Securities and Exchange Commission. It is
expected that the taxable spin-off will be completed in the fourth quarter of
2008.
Results of Operations
Three-Month
and Six-Month Periods Ended June 30, 2008 and 2007
Overview
Following
is a reconciliation of segment profitability to consolidated (loss) income before income
tax (millions of dollars). The percentage changes below and throughout this Managements
Discussion and Analysis are based on thousands of dollars and not the rounded millions of dollars
reflected throughout this section.
Three Months Ended | Six Months Ended | |||||||||||||||||||||||
June | % | June | June | % | June | |||||||||||||||||||
2008 | Change | 2007 | 2008 | Change | 2007 | |||||||||||||||||||
Products Segment profit |
$ | 4.3 | 130 | $ | 1.8 | $ | 7.3 | 73 | $ | 4.2 | ||||||||||||||
Royalty Segment profit |
15.0 | (18 | ) | 18.3 | 29.7 | (14 | ) | 34.6 | ||||||||||||||||
Contract Manufacturing
Segment profit |
2.9 | 58 | 1.9 | 5.0 | 169 | 1.9 | ||||||||||||||||||
Corporate and other
expenses* |
(23.8 | ) | 1 | (23.7 | ) | (41.9 | ) | (8 | ) | (45.4 | ) | |||||||||||||
(Loss) income before income
tax provision |
$ | (1.6 | ) | (2 | ) | $ | (1.7 | ) | $ | 0.1 | n.m. | $ | (4.7 | ) | ||||||||||
* | We do not allocate certain corporate income and expenses not directly identifiable with the respective segments, including general and administrative expenses, exploratory and preclinical research and development expenses, depreciation, investment income, interest expense and income taxes. Research and development expense is considered a corporate expense unless it relates to an existing marketed product or a product candidate enters Phase III clinical trials at which time related costs would be chargeable to one of our operating segments. |
n.m. not meaningful
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Products Segment
Products Segment profitability (millions of dollars):
Three Months Ended | Six Months Ended | |||||||||||||||||||||||
June | % | June | June | % | June | |||||||||||||||||||
2008 | Change | 2007 | 2008 | Change | 2007 | |||||||||||||||||||
Revenues |
$ | 29.2 | 17 | $ | 25.0 | $ | 56.6 | 19 | $ | 47.7 | ||||||||||||||
Cost of sales |
13.6 | 21 | 11.2 | 25.2 | 25 | 20.2 | ||||||||||||||||||
Research and development |
3.4 | (5 | ) | 3.6 | 7.2 | 19 | 6.0 | |||||||||||||||||
Selling and marketing |
7.0 | (7 | ) | 7.5 | 14.5 | (7 | ) | 15.6 | ||||||||||||||||
Amortization of
intangibles |
0.1 | (10 | ) | 0.2 | 0.3 | (10 | ) | 0.4 | ||||||||||||||||
Restructuring |
0.8 | 18 | 0.7 | 2.1 | 62 | 1.3 | ||||||||||||||||||
Segment profit |
$ | 4.3 | 130 | $ | 1.8 | $ | 7.3 | 73 | $ | 4.2 | ||||||||||||||
n.m. not meaningful
Revenues
Sales performance of individual products is provided below (millions of dollars):
Three Months Ended | Six Months Ended | |||||||||||||||||||||||
June | % | June | June | % | June | |||||||||||||||||||
Product | 2008 | Change | 2007 | 2008 | Change | 2007 | ||||||||||||||||||
Oncaspar |
$ | 13.2 | 36 | $ | 9.6 | $ | 25.5 | 49 | $ | 17.1 | ||||||||||||||
DepoCyt |
2.4 | 14 | 2.1 | 4.4 | (3 | ) | 4.5 | |||||||||||||||||
Abelcet |
6.6 | (1 | ) | 6.7 | 13.6 | (5 | ) | 14.4 | ||||||||||||||||
Adagen |
7.0 | 7 | 6.6 | 13.1 | 13 | 11.7 | ||||||||||||||||||
Totals |
$ | 29.2 | 17 | $ | 25.0 | $ | 56.6 | 19 | $ | 47.7 | ||||||||||||||
The 17 percent growth in net product sales for the three months ended June 30, 2008 compared
to the same period of 2007 was attributable primarily to higher revenues from our oncology product,
Oncaspar, which grew 36 percent. Oncaspar volume growth was
13 percent for the quarter. On a
year-to-date basis, product sales grew by 19 percent, again led by Oncaspar which benefited from a
number of favorable effects. There was a $1.2 million international shipment in the first quarter
of 2008 with no corresponding shipment in the first quarter of 2007. Oncaspar sales were also
impacted by price increases necessitated by significantly higher raw material cost and expenses
related to the development of manufacturing process improvements and technology transfer. See
discussions below in cost of sales and research and development regarding increased production
costs and production process enhancements. Continued growth in sales of Oncaspar is reflective of
its adoption in certain protocols by hospitals and cooperative groups. Sales of DepoCyt, for
treatment of lymphomatous meningitis, and Adagen, for treatment of severe immunodeficiency disease,
tend to fluctuate from quarter-to-quarter. Adagen sales in 2008 were favorably affected by a
first-quarter price increase. Abelcet, for treatment of invasive fungal infections, continues to
experience competitive pressures in the marketplace, although the rate of sales decline this
quarter is lower than the quarterly average over the past year.
Cost of sales
Cost of sales of marketed products for the three months ended June 30, 2008 was $13.6 million,
compared to $11.2 million for the comparable three-month period of 2007. Included in the
second-quarter 2008 amount was a $1.9 million amortization of a $5.0 million licensing intangible
milestone payment that was triggered during the second quarter of 2008. The remaining $3.1 million
of this milestone payment will be recognized in cost of sales over its remaining life of 6 years.
The second-quarter 2007 amount includes a $1.9 million charge for test batches produced in
connection with the transfer of production of Oncaspar and Adagen from our South Plainfield
facility to Indianapolis. Production of such batches is necessary in order to validate the new
production processes and assure the continued quality and stability
of the Oncaspar and Adagen products.
Exclusion of these two charges from the calculation would result in a cost of products sold as a
percentage of product sales of approximately 40 percent for the three months ended June 30, 2008
and 37 percent for the three months ended June 30, 2007. Cost of products sold as a percentage of
sales rose to approximately 40 percent in the first half of 2008 from 38 percent in the first half
of 2007 when adjustments are made for the two $1.9 million items referred to above. Gross margins
on Oncaspar were lower on both a quarterly and year-to-year comparison
17
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basis due to the timing of the effects of raw material price increases arising from a December 2006
supply agreement. The full effect of this cost increase was not reflected in cost of products sold
until the latter half of 2007.
Research and development
Research and development spending on marketed products, primarily Oncaspar and Adagen,
decreased 5 percent from $3.6 million in the second quarter of 2007 to $3.4 million in the second
quarter of 2008 but rose 19 percent on a year-to-date basis from $6.0 million to $7.2 million. As
previously disclosed, we are investing in the next generation of L-asparaginase. We will also
invest for the next few years to enhance and secure the supply of Oncaspar and Adagen. We intend
to continue to increase efforts to improve the manufacturing processes and pharmaceutical
properties of both Oncaspar and Adagen.
Selling and marketing expenses
Selling and marketing expenses consist primarily of sales and marketing personnel, other
commercial expense and marketing programs to support our sales force as well as medical education.
Selling and marketing expenses for the three months ended June 30, 2008 were $7.0 million, down 7
percent from $7.5 million in the second quarter of 2007. This was consistent with the year-to-date
decrease of 7 percent to $14.5 million in 2008 from $15.6 million in 2007. The decrease reflects
the effects of the sales force realignment that took place in late 2007. Also included in selling
and marketing expenses are the costs associated with our medical affairs program, which is
continuing to expand, offsetting to some degree the savings from the sales force realignment.
Restructuring
During the first quarter of 2007, we announced plans to consolidate our 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 facility are expected to
be transferred to our Indianapolis facility in 2008, resulting in the incurrence and full accrual
of certain employee severance and facility exit costs. Among these costs will be employee
severance and related benefits for affected employees estimated to be approximately $3.5 million.
Payment of these amounts has commenced and is expected to continue for the next several months.
Severance charges and related benefits of $2.2 million had been recognized through December 31,
2007. An additional $1.5 million of severance costs were recognized during the first six months of
2008, including $0.5 million accrued during the three months
ended June 30, 2008. We expect to incur other costs
during 2008 related to the relocation of goods and equipment, which will be recognized when costs
are incurred.
A reassessment of the
estimated time to complete the manufacturing consolidation resulted in
shortening the amortization period for leasehold improvements at South Plainfield resulting in an
accelerated amortization charge of $226,000 in the first quarter of
2008 and $246,000 in the second quarter of 2008 included in
restructuring expense. In addition, certain assets consisting 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 have been identified and written off. We recognized the remaining depreciation
totaling $5.1 million on assets decommissioned during the third
quarter of 2007 and an additional $147,000 write-down
during the second quarter of 2008.
During 2007, $1.9 million, the cost of required validation batches at our Indianapolis
facility for both Oncaspar and Adagen, was expensed and included in cost of product sales. There
have been no such charges for validation batches during 2008.
We will likely experience costs associated with the lease termination or the subleasing of the
South Plainfield facility, if future triggering events occur. Such costs will be incurred and
recognized when we cease use of the property in 2008.
Additionally, during 2007, we recognized $0.4 million of employee severance and related
benefits when we combined our previous two specialized sales forces into one sales team.
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Royalties Segment
(millions of dollars)
Three Months Ended | Six Months Ended | |||||||||||||||||||||||
June | % | June | June | % | June | |||||||||||||||||||
2008 | Change | 2007 | 2008 | Change | 2007 | |||||||||||||||||||
Royalty revenue |
$ | 15.0 | (18 | ) | $ | 18.3 | $ | 29.7 | (14 | ) | $ | 34.6 | ||||||||||||
Revenues
PEG-INTRON royalties
account for the majority of our total royalty revenues. In August 2007,
we sold a 25 percent interest in our future PEG-INTRON royalties. During the three months
ended June 30, 2008, PEG-INTRON royalty revenue declined 23 percent compared to the prior year
second quarter, in line with the sold interest. Royalties from Pegasys in the second quarter of
2008, showed a significant increase over the corresponding quarter of 2007 due to timing of
shipments moderating the overall decline in second-quarter royalty
revenues to 18 percent. For the six months ended June 30, 2008, the year-over-year decline in
royalty revenues was 14 percent. Royalties on PEG-INTRON decreased by 10 percent in the first
quarter of 2008, despite the sale of the 25 percent interest indicating strong underlying
performance of the product.
Costs and expenses
Current royalty revenues do not require any material specific maintenance costs. At some
point in the future, costs associated with initiation of new outlicensing agreements that could
result in our receipt of a royalty stream and, if necessary, costs necessary to maintain the
underlying technology may be charged to the Royalties segment.
Contract Manufacturing Segment
(millions of dollars)
Three Months Ended | Six Months Ended | |||||||||||||||||||||||
June | % | June | June | % | June | |||||||||||||||||||
2008 | Change | 2007 | 2008 | Change | 2007 | |||||||||||||||||||
Revenues |
$ | 6.8 | 14 | $ | 5.9 | $ | 13.4 | 59 | $ | 8.4 | ||||||||||||||
Cost of sales |
3.9 | (6 | ) | 4.0 | 8.4 | 28 | 6.5 | |||||||||||||||||
Segment profit |
$ | 2.9 | 58 | $ | 1.9 | $ | 5.0 | 169 | $ | 1.9 | ||||||||||||||
Revenues
Contract manufacturing revenue for the three months ended June 30, 2008 was $6.8 million
compared to $5.9 million for the comparable period of 2007. The increase in contract manufacturing
revenue was due to increased shipments to a new customer. On a year-to-date basis the new
customer, timing of shipments to our customers (adversely affecting the first quarter of 2007 and
having a favorable effect on first-quarter 2008 sales) and compensation for certain non-routine
services all contributed to a 59 percent growth in revenues from $8.4 million in the six months
ended June 30, 2007 to $13.4 million for the six months ended June 30, 2008. It is not anticipated
that the level of sales achieved in Contract Manufacturing in the first half of 2008 will continue
for the remainder of the year.
Cost of sales
Cost of sales for contract manufacturing for the three months ended June 30, 2008 was $3.9
million or 57 percent of sales compared to $4.0 million or 69 percent of sales for the comparable
three-month period of 2007. For the six months ended June 30, 2008, cost of sales as a percent of
sales was approximately 63 percent compared to 78 percent for the six months ended June 30, 2007.
Cost of sales for the first quarter of 2008, as a percentage of sales, was favorably affected by
the above-referenced non-routine services which contributed $0.9 million of revenues. These
services were performed in 2007 but recognition was delayed until all criteria for revenue
recognition were met. Cost of sales for the first quarter of 2007 was adversely affected by
certain start-up costs related to the new customer arrangement referred to above.
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Non-U.S Revenue
During the three months ended June 30, 2008, we had export sales and royalties on export sales
of $20.5 million, of which $14.4 million were in Europe. This compares to $21.0 million of export
sales in the comparable three-month period of 2007, of which $13.8 million were in Europe.
We had export sales and royalties on export sales of $40.7 million and $36.6 million, of which
$27.7 million and $22.6 million were in Europe, for the six months ended June 30, 2008 and 2007,
respectively.
Corporate and Other Expense
(millions of dollars)
Three Months Ended | Six Months Ended | |||||||||||||||||||||||
June | % | June | June | % | June | |||||||||||||||||||
2008 | Change | 2007 | 2008 | Change | 2007 | |||||||||||||||||||
Research and development |
$ | 10.6 | (20 | ) | $ | 13.4 | $ | 19.6 | (18 | ) | $ | 24.0 | ||||||||||||
General and administrative |
11.1 | 31 | 8.5 | 19.3 | 9 | 17.7 | ||||||||||||||||||
Other (income) expense: |
||||||||||||||||||||||||
Investment income, net |
(1.1 | ) | (53 | ) | (2.3 | ) | (3.3 | ) | (33 | ) | (4.9 | ) | ||||||||||||
Interest expense |
3.2 | (29 | ) | 4.4 | 6.6 | (27 | ) | 9.0 | ||||||||||||||||
Other, net |
| n.m. | (0.3 | ) | (0.3 | ) | (23 | ) | (0.4 | ) | ||||||||||||||
2.1 | 13 | 1.8 | 3.0 | (20 | ) | 3.7 | ||||||||||||||||||
Corporate and other
expenses |
$ | 23.8 | 1 | $ | 23.7 | $ | 41.9 | (8 | ) | $ | 45.4 | |||||||||||||
n.m. not meaningful
Research and development. For the three months ended June 30, 2008, research and development
expenses decreased by $2.8 million to $10.6 million as compared to the three months ended June 30,
2007. This twenty percent decline is generally consistent with the six-month comparison which
shows an 18% reduction in research and development spending. The decrease in spending to date in
2008 is primarily the result of timing of certain research and development expenses that were
incurred in the first half of 2007 associated with the commencement of clinical trials including the
purchase of clinical drug supply. We continue to invest 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 increased levels of research and development expenses in the second half
of 2008 as we continue to advance our programs. The second quarter of 2008 spending included $2.0
million in milestone payments related to the LNA platform. As previously disclosed, we anticipate
making milestone payments to third parties for the successful advancement of our research and
development pipeline of up to $10.0 million in 2008.
General and administrative. General and administrative expense increased to $11.1 million for
the three months ended June 30, 2008 from $8.5 million in the three months ended June 30, 2007
whereas the six months ended June 30, 2008 general and administrative spending was up $1.6 million
over the prior-year comparative period. The increase experienced during the three months ended
June 30, 2008 was due to a $1.1 million expense related to
the proposed spin-off of our biotechnology
activities. We anticipate total costs associated with the spin-off to
approximate $8.0 million to $10.0 million. In addition, spending on patent-related legal matters increased year over year. An
offsetting benefit arose from vesting of certain stock option awards in the first quarter of 2007
not recurring in first-quarter 2008.
Other (income) expense. Other (income) expense for the three months ended June 30, 2008 was
net expense of $2.1 million, as compared to net expense of $1.8 million for the three months ended
June 30, 2007. On a year-to-date basis, 2008 net expense was $3.0 million, down from $3.7 million
in 2007. Other (income) expense includes: net investment income, interest expense and other income
or expense.
Net investment income for the quarter and six months ended June 30, 2008 was adversely
affected by the impairment write-down of an auction rate security of $645 thousand reducing the
amount of investment income reported for the three months ended June 30, 2008.
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Interest expense was $3.2 million and $6.6 million for the three-month and six-month periods
ended June 30, 2008 and $4.4 million and $9.0 million for the three-month and six-month periods
ended June 30, 2007, respectively. The reduction in interest expense resulted from the declining
balance of 4.5% notes payable.
Income taxes
During the three months and six months ended June 30, 2008, we recorded a tax expense of
approximately $0.1 million and $0.3 million, respectively, which represents state and Canadian tax
liabilities and includes an adjustment to taxes payable. During the three months and six months
ended June 30, 2007, we recorded a tax expense of $0.3 million and $0.1 million, respectively,
representing state and Canadian taxes payable. No federal income tax provision was recorded for
the three months and six months ended June 30, 2008 as the estimated annual effective tax rate is
zero.
Liquidity and Capital Resources
Total cash reserves, which include cash, cash equivalents, short-term investments, restricted
investments and cash and marketable securities, were $205.9 million as of June 30, 2008, as
compared to $258.2 million as of December 31, 2007. The decrease is primarily due to the
repurchase of $59.9 million principal amount of our 4.5% notes payable. We invest our excess cash
primarily in United States government-backed securities and investment-grade corporate debt
securities.
Operating activities constituted a source of cash of $9.2 million during the six months ended
June 30, 2008 as compared to a $9.8 million use of cash in the prior year period. Net loss,
adjusted for noncash items such as depreciation, amortization and asset write-downs yielded
approximately $14.0 million in cash in the current year compared to approximately $8.7 million in
the first six months of 2007. In addition, changes in balance sheet
operating assets and liabilities consumed substantially less cash in the first six months of 2008 versus 2007 when opening levels of accounts payable
were particularly high.
Cash was provided by investing activities in the first six months of 2008 in the amount of
approximately $74.8 million as marketable securities, including $55.0 million of restricted
investments, matured or were liquidated and $4.1 million was invested in plant and equipment. The
proceeds of the restricted investments were used to repurchase our 4.5% notes payable. In the
first six months of 2007, cash provided by investing activities was $20.8 million. During that
period, we made a $17.5 million payment for a license related to our December 2006 agreement
related to Oncaspar production and invested $11.6 million in property and equipment while
approximately $50.0 million was generated by the sale or
maturity of investments, net of purchases.
Repurchase of $59.9 million principal amount of the 4.5% notes payable during the first six
months of 2008 for a cash outlay of $59.5 million constituted the primary financing cash outflow.
In the first half of 2007, $15.7 million was expended for repurchase of the 4.5% notes.
As of June 30, 2008, we had outstanding $275.0 million of convertible senior notes payable
that bear interest at an annual rate of 4% and $12.5 million of convertible subordinated notes
payable that bear interest at an annual rate of 4.5%. The 4.5% notes payable matured on July 1,
2008 and were repaid in full plus accrued interest. 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
$1.2 million and $2.5 million, respectively as of
June 30, 2008 and December 31, 2007.
In connection with the proposed spin-off of our biotechnology activities,
we plan to contribute $100.0 million in cash and $50.0 million in the form of
an interest-bearing term note as well as certain operating assets and
liabilities to the newly created company. We anticipate the spin-off will be
completed in the fourth quarter of 2008 pending effectiveness of the
registration statement and final approval by the Board of Directors.
Our current sources of liquidity are: our cash reserves; interest earned on such cash
reserves; sales of Oncaspar, DepoCyt, Abelcet and Adagen; royalties earned, which are
primarily related to sales of PEG-INTRON; and contract manufacturing revenue. Based upon our
current planned research and development activities and related costs and our current sources of
liquidity, we anticipate our current cash reserves and expected cash flow from operations will be
sufficient to meet our capital and operational requirements for the near future.
As indicated above, total cash reserves include restricted investments and cash. These
dedicated funds amounted to $14.6 million at June 30, 2008 (comprised of restricted cash only) and
$73.6 million at December 31, 2007. These segregated assets fully covered the $12.5 million and
$72.4 million, respectively, principal amount of 4.5% notes payable outstanding as of June 30, 2008
and December 31, 2007. Any residual restricted cash after the July 2008 retirement of all
remaining 4.5% notes will revert to general corporate funds.
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Included in our short-term investments at June 30, 2008 are investments in auction rate
securities totaling $6.2 million par value ($5.5 million fair value). Most are rated AAA or AA.
Recent difficulties in the auction rate securities marketplace have raised concerns about the
liquidity of such investments. One auction rate security with a par value of $1.5 million has
experienced failed auctions since late 2007. During the quarter ended June 30, 2008, the credit
rating of the issuer was downgraded by two rating agencies. Based on this information, we
concluded that the decline in estimated fair value (Level 2) to $855,000 is other than temporary
and we recognized an impairment write-down of $645,000 in investment income. We will continue to
monitor our investments in this and other auction rate securities. At this time, there are active
auctions for all but one and we continue to receive regularly scheduled interest on all of them.
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
requirement or we may 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 June 30, 2008, 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
were fully repaid in July 2008. 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 $11.32 per share and 1.9 million restricted stock units were outstanding
at June 30, 2008 that represent additional potential dilution.
Contractual Obligations
As
of June 30, 2008, we had accrued a $5.0 million liability to
Sanofi-Aventis for a licensing intangible milestone payment that was
triggered during the second quarter of 2008. The $5.0 million is
payable in January 2009.
Other major outstanding contractual obligations relate to our operating leases, inventory
purchase commitments, convertible debt, and license agreements with collaborative partners.
In July 2008, we repaid the remaining $12.5 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, 2007, other than as
described below.
Critical Accounting Policies and Estimates
A critical accounting policy is one that is both important to the portrayal of a companys
financial condition and results of operations and requires managements most difficult, subjective
or complex judgments, often as a result of the need to make estimates about the effect of matters
that are inherently uncertain.
Our consolidated financial statements are presented in accordance with accounting principles
that are generally accepted in the United States. All accounting standards effective as of June
30, 2008 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 June 30, 2008 and
December 31, 2007 (in thousands):
June 30, 2008 | December 31, 2007 | |||||||
Accounts Receivable Reductions |
||||||||
Chargebacks |
$ | 2,240 | $ | 2,578 | ||||
Cash Discounts |
158 | 159 | ||||||
Other (including returns) |
2,724 | 2,046 | ||||||
Total |
5,122 | 4,783 | ||||||
Accrued Liabilities |
||||||||
Medicaid Rebates |
1,951 | 1,382 | ||||||
Administrative Fees |
178 | 187 | ||||||
Total |
2,129 | 1,569 | ||||||
Grand Total |
$ | 7,251 | $ | 6,352 | ||||
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, 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.
At the request of the customer, certain contract manufacturing arrangements involve the
transfer of title of the finished product to the customer prior to shipment. The product in
question is manufactured to the unique specifications of the customer and cannot be used to fill
other orders. If all necessary conditions are met, including: the product is complete and ready
for shipment, the risks of ownership have passed to the customer and the customer pays for storage
of the product at our facility, we will recognize revenue.
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. We recognize the benefit of an uncertain tax
position that we have taken or expect to take on the income tax returns we file if it is more
likely than not that we will be able to sustain our position.
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 when
impairment indicators are present. Impairment indicators are 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.
Testing for the recoverability of amortizable intangible assets is performed initially by
comparing the carrying amount of the asset group to the future undiscounted net cash flows to be
generated by the assets. 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 assets within the asset group must be determined and we would record an impairment charge
for any excess of the carrying amount over the fair value. These evaluations involve amounts and
forecasts 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 have elected the modified prospective
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transition method for SFAS No. 123R which requires that compensation costs be recorded, as earned,
for all unvested stock options and restricted stock awards outstanding at June 30, 2005.
The impact that share-based payment awards will have on our results of operations is a
function of the number of shares awarded, vesting and the trading price of our stock at date of
grant, combined with the application of the Black-Scholes valuation model. 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.
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Recently Issued Accounting Standards, Not Adopted as of June 30, 2008
In December 2007, the FASB issued two statements that would apply prospectively to potential,
business combinations for which the acquisition date is on or after January 1, 2009. Early
application is not permitted. These pronouncements would be adopted at such time as we undertake a
business combination and will have no impact on our current or historical financial statements.
SFAS No. 141R, Business Combinations, retains the fundamental requirements of purchase accounting
but changes, among other things, the way assets and liabilities are recognized such as requiring
recognition of in-process research and development as an intangible
asset at fair value. It also calls for the
recognition of most acquisition costs as expense rather than part of the total acquisition cost.
SFAS No. 160, Noncontrolling Interests in Consolidated Financial Statements, establishes
accounting and reporting standards for the noncontrolling (minority) interest in a subsidiary and
for the deconsolidation of a subsidiary.
In December 2007, the Emerging Issues Task Force (EITF) issued EITF 07-1, Accounting for
Collaborative Arrangements. Effective beginning in 2009, the consensus prohibits participants in
a collaborative agreement from applying the equity method of accounting to activities performed
outside a separate legal entity and requires gross or net presentation of revenues and expenses by
the respective parties depending upon their roles in the collaboration. We are in the process of
evaluating the possible impact the consensus may have on our financial statements, but do not
expect it to be material to our financial position or results of operations.
The FASB ratified the consensus of the Emerging Issues Task Force in Issue No. 07-5 (EITF
07-5), Determining Whether an Instrument (or Embedded Feature) Is Indexed to an Entitys Own
Stock in June 2008. The issue addresses the determination of whether an instrument (or an
embedded feature) is indexed to an entitys own stock and establishes a two-step approach with
which to make the determination. Under current U.S. GAAP, the conversion options embedded in our
convertible debt are considered to be indexed to our stock and, as a result, we are not required to
bifurcate the option from the note payable and mark the option to market each reporting period. We
are in the process of evaluating the provisions of EITF 07-5, which would take effect prospectively
in the first quarter of 2009, but at this time do not believe there will be a material effect on
our financial position or results of operations. There would be no effect on our cash flows.
Factors That May Affect Future Results
There are forward-looking statements contained herein, which can be identified by the use of
forward-looking terminology such as the words believes, expects, may, will, should,
potential, anticipates, plans or intends and similar expressions. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors that may cause actual
results, events or developments to be materially different from the future results, events or
developments indicated in such forward-looking statements. Such factors include, but are not
limited to:
| The risk that we will not achieve success in our research and development efforts, including clinical trials conducted by us or our collaborative partners. | ||
| The risk that we will experience operating losses for the next several years. | ||
| The risk that there will be a decline in sales of one or more of our marketed products or products sold by others from which we derive royalty revenues. Such sales declines could result from increased competition, loss of patent protection, pricing, supply shortages and/or regulatory constraints. | ||
| The risk that we will be unable to obtain critical compounds used in the manufacture of our products at economically feasible prices or at all, or one of our key suppliers will experience manufacturing problems or delays. | ||
| Decisions by regulatory authorities regarding whether and when to approve our regulatory applications as well as their decisions regarding labeling and other matters could affect the commercial potential of our products or developmental products. | ||
| The risk that we will fail to obtain adequate financing to meet our future capital and financing needs. | ||
| The risk that key personnel will leave the Company. |
A more detailed discussion of these and other factors that could affect our results is
contained in our filings with the U.S. Securities and Exchange Commission, including our Annual
Report on Form 10-K for the year ended December 31, 2007. 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
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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 those related to our Executive Deferred Compensation
Plan, by year of maturity (twelve-month intervals ending June 30 of the year indicated) as of June
30, 2008 (in thousands):
2009 | 2010 | 2011 | Total | Fair Value | ||||||||||||||||
Fixed Rate |
$ | 48,090 | $ | 58,225 | $ | 12,537 | $ | 118,852 | $ | 117,997 | ||||||||||
Average Interest Rate |
5.00 | % | 6.10 | % | 5.26 | % | 5.57 | % | ||||||||||||
Variable Rate |
5,505 | | | 5,505 | 5,505 | |||||||||||||||
Average Interest Rate |
3.49 | % | 3.49 | % | ||||||||||||||||
$ | 53,595 | $ | 58,225 | $ | 12,537 | $ | 124,357 | $ | 123,502 | |||||||||||
Our convertible notes payable outstanding have fixed interest rates. Accordingly, the fair
values of the respective issues will fluctuate as market rates of interest rise or fall. Fair
values are also affected by changes in the price of our common stock. Our 4% convertible senior
unsecured notes in the principal amount of $275.0 million at June 30, 2008 are due June 1, 2013 and
have a fair value of $244.9 million at June 30, 2008.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures.
Our management, under the direction of our Chief Executive Officer and Chief Financial
Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in
Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, (the Exchange
Act)) as of June 30, 2008. Based on the evaluation, our Chief Executive Officer and Chief
Financial Officer have concluded that our disclosure controls and procedures were effective as of
June 30, 2008.
Changes in Internal Controls
There were no changes in our internal controls over financial reporting as such term is
defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during the period covered by this
report that have materially affected, or are reasonably likely to materially affect our internal
control over financial reporting.
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PART II OTHER INFORMATION
Item 4. Submission of Matters to a Vote of Security Holders
(a) | An annual meeting of stockholders was held on May 22, 2008. | ||
(b) | Rolf A. Classon, Robert LeBuhn and Robert C. Salisbury were re-elected as Class III directors of the Company. The term of office, as a director for each of Jeffrey H. Buchalter, Goran A. Ando, M.D, Victor P. Micati and Philip M. Renfro, continued after the annual meeting. | ||
(c) | The matters voted upon at the annual meeting and the results of the voting, including broker non-votes where applicable, are set forth below. All proposals were approved by the requisite percentage: |
(i) | The stockholders voted 30,485,452 shares in favor and 6,962,103 shares withheld with respect to the election of Rolf A. Classon as a Class III director of the Company. |
The stockholders voted 31,279,136 shares in favor and 6,168,419 withheld with
respect to the election of Robert LeBuhn. as a Class III director of the
Company.
The stockholders voted 31,549,976 shares in favor and 5,897,579 withheld with
respect to the election of Robert C. Salisbury as a Class III director of the
Company.
(ii) | The stockholders voted 32,964,265 shares in favor, 1,933,473 shares against and 2,549,817 shares abstained with respect to a proposal to ratify the selection of KPMG LLP to audit our consolidated financial statements for the fiscal year ending December 31, 2008. |
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Item 6. Exhibits
(a) Exhibits required by Item 601 of Regulation S-K.
Exhibit | Reference | |||||
Number | Description | No. | ||||
3(i)
|
Amended and Restated Certificate of Incorporation | (1 | ) | |||
3(ii)
|
Amended and Restated By-laws | (2 | ) | |||
3(iii)
|
Amendment dated July 31, 2007 to Amended and Restated Bylaws | (3 | ) | |||
3(iv)
|
Amendment dated November 21, 2007 to Amended and Restated Bylaws | (4 | ) | |||
4.1
|
Rights Agreement dated May 17, 2002 between the Company and Continental Stock Transfer Trust Company, as rights agent | (5 | ) | |||
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 | (6 | ) | |||
4.3
|
Second Amendment to the Rights Agreement, dated as of January 7, 2008 between the Company and Continental Stock Transfer and Trust Company, as rights agent. | (7 | ) | |||
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. |
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 August 3, 2006. | |
(3) | Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 filed August 2, 2007. | |
(4) | Current Report on Form 8-K filed on November 26, 2007. | |
(5) | Form 8-A12G (File No. 000-12957) filed with the Commission on May 22, 2002. | |
(6) | Form 8-A12G/A (File No. 000-12957) filed with the Commission on February 20, 2003. | |
(7) | Current Report on Form 8-K filed January 8, 2008. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ENZON PHARMACEUTICALS, INC. (Registrant) |
||||
Date: August 8, 2008 | By: | /s/ Jeffrey H. Buchalter | ||
Jeffrey H. Buchalter, | ||||
Chairman, President and Chief Executive Officer (Principal Executive Officer) |
||||
Date: August 8, 2008 | By: | /s/ Craig A. Tooman | ||
Craig A. Tooman | ||||
Executive Vice President, Finance and Chief Financial Officer (Principal Financial Officer) |
||||
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