During the first quarter of 2010, our workforce reduction involved 64 employees and resulted in an expense of $6.1 million for separation benefits. These actions related primarily to the sale of the specialty pharmaceutical business and affected employees who were previously engaged in activities related to the divested business but who did not transfer to the employment of the purchaser. These employees were provided with separation benefits after certain transition periods, during which they assisted with an orderly transfer of activities and information to the purchaser. In addition, we reassessed our staffing requirements subsequent to the sale in light of the lessened demands on many of our general and administrative functions. Effective February 22, 2010, our then President and Chief Executive Officer resigned from the Company. For the quarter ended March 31, 2010, we expensed $3.8 million for severance payments and benefits that were payable under the terms of this individual’s employment agreement. This amount was reduced during the quarter ended June 30, 2010 by approximately $0.2 million once the termination agreement was executed. Payments due pursuant to the termination agreement were made during the third quarter of 2010.
n.m. – not meaningful
Net investment income was $0.5 million for the three months ended March 31, 2011, as compared to $1.0 million for the three months ended March 31, 2010. The decline reflects the lower balances of investment holdings and a shift to shorter maturity and lower risk investments.
Interest expense was $1.5 million for the three months ended March 31, 2011. Interest expense for the three months ended March 31, 2010 was $2.7 million, which included a net effect related to the first quarter 2010 conversion of $115.6 million principal amount of our 4% notes subsequent to the sale of our specialty pharmaceutical business. The net effect of forgone interest and the write-off of a pro rata amount of deferred debt issuance costs amounted to $0.8 million and was charged to interest expense during the first quarter of 2010 at the time of the notes conversion. The $0.8 million was adjusted in the fourth quarter of 2010 to credit interest expense and charge additional paid-in capital to reflect the capital nature of the transaction. The noncash adjustment was not material to the first or fourth quarters nor to the full year 2010 results of operations. Additionally, the decline in interest expense is attributable to lower principal amounts outstanding in 2011 compared to 2010.
During the three months ended March 31, 2011 and 2010, the Company recorded no income tax expense because the estimated annual effective tax rate was zero. The sale of the specialty pharmaceutical business, including the sale of in-process research and development, was a taxable transaction for federal income tax purposes, although it resulted in no federal income tax liability due to the tax basis the Company had in divested assets and the net operating loss generated in 2010. As of March 31, 2011, 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.
The cash proceeds received from the sale of the specialty pharmaceutical business, including a second-quarter 2010 working capital adjustment, amounted to approximately $309.0 million. Of this amount, $40.9 million was allocated to the sale of in-process research and development and included in continuing operations. The net proceeds then attributable to discontinued operations yielded a gain of $175.4 million. The results of operations of the specialty pharmaceutical business for the period in January 2010 preceding the sale amounted to income of $3.6 million comprising the remainder of the $179.0 reported in 2010 as income and gain from discontinued operations. The gain from discontinued operations was subsequently adjusted to $176.4 million in the fourth quarter of 2010 to recognize $1.0 million of currency translation gains that had been included in accumulated other comprehensive income but should have been recognized as part of the gain on sale.
Liquidity and Capital Resources
Total cash reserves, which include cash, cash equivalents, short-term investments and marketable securities, were $418.9 million as of March 31, 2011, as compared to $460.1 million as of December 31, 2010. The decrease was primarily attributable to the Company’s on-going share repurchase program. During the three months ended March 31, 2011, the Company repurchased and retired 3,853,073 shares at a cost of $41.5 million, or an average cost per share of approximately $10.77.
For the three months ended March 31, 2011, cash provided by operating activities of continuing operations was $1.0 million compared to cash provided in the first quarter of 2010 of $39.9 million. Income from continuing operations in the first quarter of 2011, adjusted for noncash and non-operating items, constituted a source of cash of approximately $3.5 million. Changes in various working capital accounts comprised the partially offsetting $2.5 million.
Investing activities generated approximately $13.1 million of cash in the first quarter of 2011 primarily from maturities of marketable securities. This compares to $279.5 million of cash provided by investing activities during the first quarter of 2010, which was primarily attributable to the $263.1 million net proceeds from the January 2010 sale of the specialty pharmaceutical business (exclusive of the amount apportioned to the sale of in-process research and development reported in operating revenue).
Net cash used in financing activities was $41.7 million in the first quarter of 2011 versus $5.0 million in the first quarter of 2010. During the first quarter of 2011, we utilized $41.4 million to repurchase shares of the Company’s common stock on the open market as part of the $200.0 million share repurchase program initiated in December of 2010. Fees of approximately $0.1 million incurred to purchase the shares were reflected in cash flows from operating activities. The share repurchase program is designed as a means by which to return to shareholders value derived from the sale of the specialty pharmaceutical business. Through April 30, 2011 there have been a total of 5.7 million shares acquired at a cumulative cost of $62.2 million, inclusive of transaction costs.
As of March 31, 2011, we had outstanding $134.5 million of convertible senior notes that mature on June 1, 2013 and bear interest at an annual rate of 4%. Interest is payable on June 1 and December 1 for the 4% notes. Accrued interest on the notes was $1.8 million and $0.4 million, respectively, as of March 31, 2011 and December 31, 2010.
Our current sources of liquidity are our cash reserves; interest earned on such cash reserves and royalties earned - primarily related to sales of PEGINTRON. Based upon our current planned research and development activities and related costs, our current sources of liquidity and the planned remaining purchases of our outstanding stock under our existing share repurchase program, we anticipate our current cash reserves will be sufficient to meet our capital and operational requirements for the near future. While we believe that our current sources of liquidity will be adequate to satisfy our capital and operational needs for the near future, it is likely that we will need to obtain additional financing or enter into a collaborative arrangement to sustain our research and development efforts prior to the time we are able to commercialize any of our product candidates. There can be no assurance, however, that we will be able to obtain additional funds or engage a collaborator on acceptable terms, if at all. If we are unable to obtain adequate financing or collaborative support, we may be required to curtail our research and development activities and/or license our product candidates to third parties on terms that are not favorable to us.
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 limited purposes. As of March 31, 2011, 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. As of March 31, 2011, the maximum potential dilutive effect of conversion of the 4% notes is approximately 14.1 million shares using the conversion rate of 104.712 shares per $1,000 principal amount currently in effect. If we were to experience a fundamental change as defined in the indenture agreement, the conversion rate could be enhanced for the benefit of the note holders which would yield greater dilution. Notes payable are discussed in greater detail in Liquidity and Capital Resources above and in the notes to our condensed consolidated financial statements.
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In addition, stock options to purchase 3.8 million shares of our common stock at a weighted average exercise price of $12.27 per share and 0.6 million restricted stock units were outstanding at March 31, 2011, which represent additional potential dilution.
Contractual Obligations
Our major outstanding contractual obligations relate to our operating leases, convertible debt, and license agreements with collaborative partners. There have been no material changes since December 31, 2010 with respect to our contractual obligations.
Critical Accounting Policies and Estimates
A critical accounting policy is one that is both important to the portrayal of a company’s financial condition and results of operations and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.
Our condensed consolidated financial statements are presented in accordance with U.S. GAAP. All professional accounting standards effective as of March 31, 2011 have been taken into consideration in preparing the consolidated financial statements. The preparation of the consolidated financial statements requires estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures. Some of those estimates are subjective and complex, and, consequently, actual results could differ from those estimates. The following accounting policies have been highlighted as significant because changes to certain judgments and assumptions inherent in these policies could affect our consolidated financial statements.
We base our estimates, to the extent possible, on historical experience. Historical information is modified as appropriate based on current business factors and various assumptions that we believe are necessary to form a basis for making judgments about the carrying value of assets and liabilities. We evaluate our estimates on an ongoing basis and make changes when necessary. Actual results could differ from our estimates.
Revenues
Royalties under our license agreements with third-parties and pursuant to the sale of our specialty pharmaceutical business are recognized when reasonably determinable and earned through the sale of the product by the third-party and collection is reasonably assured. Notification from the third-party licensee of the royalties earned under the license agreement is the basis for royalty revenue recognition. This information generally is received from the licensees in the quarter subsequent to the period in which the sales occur.
Contingent payments due under the asset purchase agreement related to the sale of the specialty pharmaceutical business are recognized as income when the milestone has been achieved and collection is assured. Such payments are non-refundable and no further effort is required on the part of the Company or the other party to complete the earning process. 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.
The sale of the specialty pharmaceutical business involved the application of guidance regarding multiple deliverables in separating the revenues associated with the sale of in-process research and development from the other elements of the transaction, namely the assets sold as part of discontinued operations and our continuing involvement in contract research activities. We determined that the in-process research and development had value to the buyer of the specialty pharmaceutical business on a stand-alone basis and that there was objective and reliable evidence available to support the allocation of the total purchase price to the respective units of accounting.
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Research and Development Expenses
We accrue expenses for costs for work performed by contract research organizations, contract manufacturing organizations and others based upon the estimated amount of the total effort completed on each order, study or project using factors such as number of lots produced, number of patients enrolled, the number of active clinical sites and the duration for which the patients will be enrolled in the study. We base the estimates on the information available at the time. Additional information may come available at a later date that would enable us to develop a more accurate estimate. Such changes in estimate are generally recognized in the period when the information is first known.
Income Taxes
Under the asset and liability method of accounting for income taxes, deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. 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 realized. A valuation allowance is provided for when it is more likely than not some portion or all of the deferred tax assets will not be realized. As of March 31, 2011, we believe, based on future projections, that it is more likely than not that our net deferred tax assets 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 we will be able to sustain our position.
Share-Based Payment
Compensation cost, measured by the fair value of the equity instruments issued, adjusted for estimated forfeitures, is recognized in the financial statements as the respective awards are earned. 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 and fair value of our stock at date of grant or modification. Fair value of share-based payments is determined using the Black-Scholes valuation model which employs weighted average assumptions for expected volatility of our stock, expected term until exercise of the options, the risk free interest rate, and dividends, if any. Expected volatility is based on our historical stock price information.
Forward-Looking Information and 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:
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• | The risk that we will not achieve success in our research and development efforts, including clinical trials conducted by us or our collaborative partners. |
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• | The risk that we may be unable to recruit and qualify a sufficient number of patients for our trials and/or there may be the need to delay, suspend or terminate trials for various reasons. |
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• | The risk that we will experience operating losses for the next several years. |
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• | The risk that there will be a decline in sales of one or more of the products sold by others from which we derive royalty revenues. |
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• | Decisions by regulatory authorities regarding whether and when to approve our regulatory applications. |
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• | The risk that we will fail to obtain adequate financing to meet our future capital and financing needs. |
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• | The risk that key personnel will leave our company. |
A more detailed discussion of these and other factors that could affect results is contained in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2010. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. No assurance can be given that the future results covered by the forward-looking statements will be achieved. All information contained herein is as of the date of this report and we undertake no duty to update this information.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk.
The majority of our holdings of financial instruments consist of money market funds, classified as cash equivalents, and debt instruments, classified as available-for-sale securities. 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. We seek reasonable assuredness of the safety of principal and market liquidity by investing in rated fixed income securities while at the same time seeking to achieve a favorable rate of return. Our market risk exposure consists principally of exposure to changes in interest rates. Our holdings are also exposed to the risks of changes in the credit quality of issuers the majority of which are rated A1 or better. We typically invest the majority of our investments in the shorter-end of the maturity spectrum. Cash equivalents are primarily held in a number of AAA-rated institutional money market funds as well as several corporate and U.S. government-sponsored entities’ debt securities.
The table below presents the principal amounts and related weighted-average interest rates of our marketable debt securities, excluding those related to our Executive Deferred Compensation Plan, by year of maturity (twelve-month intervals ending March 31 of the year indicated) as of March 31, 2011 (in thousands):
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| | 2012 | | 2013 | | Total | | Fair Value | |
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Fixed Rate | | $ | 35,152 | | $ | 9,809 | | $ | 44,961 | | $ | 45,612 | |
Average Interest Rate | | | 4.67 | % | | 6.32 | % | | 5.03 | % | | | |
Variable Rate | | | — | | | — | | | — | | | | |
Average Interest Rate | | | — | | | — | | | — | | | | |
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| | $ | 35,152 | | $ | 9,809 | | $ | 44,961 | | $ | 45,612 | |
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Our convertible senior unsecured notes have fixed interest rates. Accordingly, the quoted fair values of our notes 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 Notes in the principal amount of $134.5 million at March 31, 2011 are due June 1, 2013 and have a fair value of $165.9 million at March 31, 2011.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, under the direction of our Chief Operating Officer and Vice President, Finance, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, (the Exchange Act)) as of March 31, 2011. Based on the evaluation, our Chief Operating Officer and Vice President, Finance have concluded that our disclosure controls and procedures were effective as of March 31, 2011.
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 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Common Stock
In the first quarter of 2011, we repurchased shares of our Common Stock as set forth in the following table:
ISSUER PURCHASES OF EQUITY SECURITIES
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Period | | (a) Total Number of Shares Purchased | | (b) Average Price Paid per Share | | (c) Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (1) | | (d) Maximum Number (or Approximate Dollar Value) of Shares that May Yet Be Purchased Under the Plans or Programs | |
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January 1 – January 31, 2011 | | | 353,854 | | $ | 11.95 | | | 353,854 | | $ | 195,399,505 | |
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February 1 – February 28, 2011 | | | 858,920 | | $ | 11.20 | | | 858,920 | | $ | 185,776,398 | |
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March 1 – March 31, 2011 | | | 2,640,299 | | $ | 10.48 | | | 2,640,299 | | $ | 158,110,102 | |
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Total | | | 3,853,073 | | $ | 10.77 | | | 3,853,073 | | $ | 158,110,102 | |
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| (1) Share repurchase program announced December 21, 2010 whereby Enzon’s board of directors authorized the repurchase of up to $200.0 million of its outstanding shares of common stock. Through December 31, 2010, the Company had repurchased 30,000 shares at an average cost of $12.45 per share for a total expenditure of $373,642. |
Item 4. (Removed and Reserved)
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Item 6. Exhibits.
(a) Exhibits required by Item 601 of Regulation S-K.
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Exhibit | | | | Reference |
Number | | Description | | No. |
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3(i) | | | Amended and Restated Certificate of Incorporation dated May 18, 2006, together with that Certificate of Amendment to the Amended and Restated Certificate of Incorporation date July 13, 2010 | | (1) |
3(ii) | | | Second Amended and Restated By-laws effective March 11, 2011 | | (2) |
4.1 | | | Rights Agreement dated May 17, 2002 between the Company and Continental Stock Transfer & Trust Company, as rights agent | | (3) |
4.2 | | | First Amendment to the Rights Agreement, dated as of February 19, 2003 between the Company and Continental Stock Transfer & Trust Company, as rights agent | | (4) |
4.3 | | | Second Amendment to the Rights Agreement, dated as of January 7, 2008 between the Company and Continental Stock Transfer & Trust Company, as rights agent | | (5) |
4.4 | | | Third Amendment to the Rights Agreement, dated as of July 23, 2009, between the Company and Continental Stock Transfer and Trust Company, as rights agent | | (6) |
31.1 | | | Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | * |
31.2 | | | Certification of Principal Financial 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 Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | | * |
Referenced exhibit was previously filed with the Commission as an exhibit to the Company’s filing indicated below and is incorporated herein by reference to that filing:
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(1) | Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 filed August 9, 2010 |
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(2) | Current Report on Form 8-K filed March 17, 2011 |
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(3) | Form 8-A12G (File No. 000-12957) filed May 22, 2002 |
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(4) | Form 8-A12G/A (File No. 000-12957) filed February 20, 2003 |
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(5) | Form 8-A12G/A (File No. 000-12957) filed January 8, 2008 |
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(6) | Form 8-A12G/A (File No. 000-12957) filed July 24, 2009 |
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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.
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| ENZON PHARMACEUTICALS, INC. |
| (Registrant) |
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Date: May 6, 2011 | /s/Ralph del Campo |
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| Ralph del Campo |
| Chief Operating Officer |
| (Principal Executive Officer) |
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Date: May 6, 2011 | /s/Mark L. Ogden |
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| Mark L. Ogden |
| Vice President, Finance |
| (Principal Financial Officer and |
| Principal Accounting Officer) |