Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to "Enzon," the "Company," "we," "us," or "our" and similar terms mean
Enzon Pharmaceuticals, Inc.and its subsidiaries. Overview
We receive royalty revenues from existing licensing arrangements with other companies primarily related to sales of six marketed drug products, namely, PegIntron ® , Sylatron ® , Macugen ® , CIMZIA ® , Oncaspar and Adagen. The primary source of our royalty revenues is sales of PegIntron, which is marketed by Merck. We currently have no clinical operations and limited corporate operations. Royalty revenues from sales of PegIntron accounted for approximately 85% and 91% of our total royalty revenues for the three months ended
June 30, 2014and 2013, respectively, andapproximately 80%, and 89% of the Company's total royalty revenues for the six months ended June 30, 2014and 2013, respectively. We were previously dedicated to the research and development of innovative therapeutics for patients with high unmet medical needs. In December 2012, we announced that our Board of Directors retained Lazard to act as financial advisor in a review of the possible sale or disposition of one or more corporate assets or a sale of our company and that our Board of Directors established a special committee to oversee our sale review process. In connection with our sale review process, we substantially suspended all clinical development activities with a goal of conserving capital and maximizing value returned to our stockholders. In April 2013, we announced that we had concluded a review of the sale or disposition of one or more corporate assets or a sale of our company. The review did not result in a definitive offer to acquire our company or all or substantially all of our assets. In the same announcement, we also announced that our Board of Directors intends to distribute excess cash, expected to arise from ongoing royalty revenues, in the form of periodic dividends to stockholders. In April 2013, we entered into an asset purchase agreement with Belrose Pharma, Inc.("Belrose"), for the sale of all right, title and interest to our Customized PEGylation platform and related assets. The assets included (i) intellectual property and know-how associated with the PEGylation platform, (ii) patents and know-how related to PEG SN-38, (iii) patents and know-how associated with certain of our internal clinical programs and (iv) certain related supplies and equipment.
September 2013, we entered into a sublease agreement, which was amended and restated in November 2013, with Axcellerate Pharma, LLC("Axcellerate"), pursuant to which we sublease to Axcellerate a portion of our premises consisting of approximately 30,000 rentable square feet of the building located at 20 Kingsbridge Road, Piscataway, New Jerseyand a share of related parking areas. The term of the sublease commenced on November 14, 2013and will expire on July 30, 2021. The monthly fixed rent payable by Axcellerate to us under the sublease is as follows: (i) in year one, $10,417, (ii) in year two, $15,625, (iii) in year three, $20,833, (iv) in year four, $26,042and (v) in each of years five through eight, $35,000. The sublease also provides for Axcellerate to pay additional rent to cover its applicable share of real estate taxes, operating expenses, sewer and gas usage, water usage, electricity usage and certain other charges incurred by Axcellerate.
March 2014, the Company entered into a novation agreement with Zhejiang Hisun Pharmaceutical Co., Ltd. ("Hisun") and Belrose (the "Novation Agreement"), pursuant to which the parties confirmed the novation of the Company's Collaboration Agreement with Hisun to Belrose. As a consequence of entering into the Novation Agreement the Company received a gross amount of $550,000from Hisun, the amount of a receivable previously written off, and paid $249,565to Belrose. The recording of these transactions resulted in a net reduction of general and administrative expense of $300,435during the first quarter of 2014. We wound down our remaining research and development activities during 2013. We have no intention of resuming any clinical development activities or acquiring new sources of royalty revenues. Throughout Management's Discussion and Analysis, the primary focus is on the results of operations, cash flows, financial condition and future outlook of our business. The percentage changes throughout the following discussion are based on amounts stated in thousands of dollars and not the rounded millions of dollars reflected in this section. Results of Operations Revenues:
Royalties (in millions of dollars):
Three Months Ended Six Months Ended June 30, June 30, % % 2014 Change 2013 2014 Change 2013 Royalty revenue
$ 7.7(3 ) $ 8.0 $ 16.7(5 ) $ 17.6Most of our royalty revenues are derived from sales of PegIntron. Royalty revenues from sales of PegIntron by Merck accounted for approximately 85% and 91% of our total royalty revenues for the three months ended June 30, 2014and 2013, respectively, and 80% and 89% of our total royalty revenues for the six months ended June 30, 2014and 2013, respectively. Royalty revenues from Merck have been declining and this trend is expected to continue. Merck has announced that its sales of PegIntron in the first half of 2014 decreased 15% to $246 millionfrom $289 millionin the in the first half of 2013 The following table summarizes our PegIntron royalties earned (in millions of dollars): Three Months Ended Six Months Ended June 30, Dollar Percent June 30, Dollar Percent PEGINTRON royalties from: 2014 2013 Change Change
2014 2013 Change Change US sales
$ 0.63 $ 0.90 $ (0.27 )
2.01 2.48 (0.47 )
-19 % 3.92 4.46 (0.54 ) -12 % Foreign sales -
0.91 1.34 (0.43 )
-32 % 1.80 3.51 (1.71 ) -49 % Foreign sales - Other
3.04 2.59 0.45 17 % 6.30 5.65 0.65 12 % Total
$ 6.59 $ 7.31 $ (.72 )-10 % $ 13.38 $ 15.59 $ (2.21 )-14 % 13 Miscellaneous Income
Miscellaneous income was
Miscellaneous income was
$631,000and $12,000for the six months and three months ended June 30, 2013, respectively. In the first quarter of 2013, we recorded a milestone event related to the licensing of PEG-SN38 as part of the Collaboration Agreement with Hisun. In addition, miscellaneous income consists of rental receipts from the sublease of unused manufacturing and excess office space for which we no longer have lease commitments. The underlying lease expense is reflected in general and administrative expenses. Operating Expenses: Research and Development
During the first six months of 2014 we incurred no research and development expenses, a decrease of
$1.9 millionfrom the first half of the prior year and a decrease of $0.3 millionfrom the second quarter of 2013, as a result of our withdrawal from research and development activities. 14
General and Administrative(in millions of dollars):
Three Months Ended June 30, Six Months Ended June 30, % % 2014 Change 2013 2014 Change 2013 General and administrative
$ 0.84(65 ) $ 2.4 $ 1.34(75 ) $ 5.3General and administrative expenses declined by $1.56 million, or 65%, to $0.84 millionfor the second quarter of 2014 from $2.4 millionfor the second quarter of 2013. Salaries and benefits expenses declined by $0.7 millionas a result of the restructuring implemented in the first quarter of 2013. The remainder of the decrease in general and administrative expenses was attributable to reduced costs for insurance and depreciation. General and administrative expenses declined by $3.96 million, or 75%, to $1.3 millionfor the first half of 2014 from $5.3 millionfor the first half of 2013. Salaries and benefits expenses declined by $1.6 millionas a result of the restructuring implemented in the first half of 2013. Additionally, during the first half of 2014, in connection with an agreement with Zhejiang Hisun Pharmaceutical Co., Ltd. ("Hisun") and Belrose Pharma, Inc.("Belrose"), pursuant to which the parties confirmed the novation of the Company's Collaboration Agreement with Hisun to Belrose (the "Novation Agreement"), we received $0.6 millionthat was a receivable previously written off from Hisun. Of this amount, $0.3 millionwas paid to Belrose. The recording of both this receipt and the related payment resulted in a net decrease to general and administrative expense of $0.3 million. There was no comparable amount in the corresponding period in the prior year. The remainder of the decrease in general and administrative expenses was primarily attributable to reduced costs for stock-based compensation, legal expense and accounting fees. These decreases were the result of specific cost-cutting and cost-containment efforts by management and the ability to lower overhead by outsourcing all critical administrative functions. Restructurings
March 2013, in an effort to continue to cut ongoing operating expenses, the Company committed to a plan to reduce its workforce from 19 employees to 12 employees. During the first quarter of 2013, we incurred restructuring charges of $2.5 million, of which $1.6 millionresulted in cash expenditures paid and expensed during the quarter. The remaining $0.9 millionwas substantially paid during the second quarter of 2013. There were no similar costs in the comparable 2014 quarter as we have outsourced substantially all of our executive and administrative functions and, since January 1, 2014, we have only one employee.
Other Income (Expense)(in millions of dollars):
Three Months Ended June 30, Six Months Ended June 30, % % 2014 Change 2013 2014 Change 2013 Other income (expense): Investment income, net $ - (100 )
$ 0.1$ - (100 ) $ 0.5Interest expense - (100 ) (0.8 ) - (100 ) (2.1 ) Other, net - (100 ) 0.6 0.1 (89 ) 0.9 $ - nm $ (0.1 ) $ 0.1114 $ (0.7 )
There was no net investment income during the six and three-month periods ended
June 30, 2014, inasmuch as we had no marketable securities during that period. Net investment income was $0.1 millionand $0.5, respectively, for the three and six-month periods ended June 30, 2013. We incurred no interest expense during the six and three-month periods ended June 30, 2014, because in June 2013, we retired the remaining outstanding principal balance of our 4% convertible notes at par. Interest expense related to this debt was $0.8 millionand $2.1 millionfor the three and six-month periods ended June 30, 2013. 15
Liquidity and Capital Resources
Our current sources of liquidity are (i) our cash on hand, (ii) anticipated royalty revenues from third-party sales of marketed drug products that utilize our proprietary technology (primarily anticipated royalty revenues from sales of PegIntron) and (iii) anticipated rental income from our sublease to Axcellerate. While we no longer have any research and development activities, we continue to retain rights to receive royalties from existing licensing arrangements with other companies. We believe that our anticipated royalty revenues, primarily anticipated royalty revenues from sales of PegIntron, together with our anticipated rental income from our sublease to Axcellerate and our cash on hand, will be sufficient to fund our operations, at least, through
September 30, 2015. However, there can be no assurance that we will receive amounts of royalty revenues or rental income as anticipated. Cash was $21.5 millionas of June 30, 2014, as compared to $6.5 millionas of December 31, 2013. The increase was almost totally attributable to our operating activities, which provided $14.8 million, of which $15.4 millionwas our net income for the six-month period.
In the first half of 2014, the net cash provided by investing activities was
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 (SPEs), which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually limited purposes. As of
Our major outstanding contractual obligations relate to our operating leases and license agreements with collaborative partners. There have been no material changes since
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 consolidated financial statements are presented in accordance with accounting principles that are generally accepted in the U.S. All applicable U.S. GAAP accounting standards effective as of
June 30, 2014have 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 and estimates 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 former 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 our former 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. 17 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 recovered or settled. A valuation allowance on net deferred tax assets 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
June 30, 2014, we believe, based on our 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 we will be able to sustain our position. Stock-Based Compensation
The Company recognizes the cost of all share-based payment transactions at fair value. 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 the Company's results of operations is a function of the number of shares awarded, the trading price of the Company's stock at date of grant or modification and vesting, including the likelihood of achieving performance goals. Furthermore, the application of the Black-Scholes valuation model employs weighted average assumptions for expected volatility of the Company's stock, expected term until exercise of the options, the risk free interest rate, and dividends, if any to determine fair value. Expected volatility is based on historical volatility of the Company's common stock; the expected term until exercise represents the weighted average period of time that options granted are expected to be outstanding giving consideration to vesting schedules and the Company's historical exercise patterns; and the risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for periods corresponding with the expected life of the option. 18
Forward-Looking Information and Factors That May Affect Future Results
This Quarterly Report on Form 10-Q contains forward-looking statements within the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in the Quarterly Report on Form 10-Q, other than statements that are purely historical, are forward-looking statements. Forward-looking statements can be identified by the use of forward-looking terminology such as the words "believes," "expects," "may," "will," "should," "potential," "anticipates," "plans" or "intends" or the negative thereof, or other variations thereof, or comparable terminology, or by discussions of strategy. Forward-looking statements are based upon management's present expectations, objectives, anticipations, plans, hopes, beliefs, intentions or strategies regarding the future and are subject to known and unknown risks and uncertainties that could cause actual results, events or developments to be materially different from those indicated in such forward-looking statements, including, but not limited to, the following risks and uncertainties:
· Our Board of Directors may decide in the future to pursue a dissolution
and liquidation of the Company. · We derive most of our royalty revenues from continued sales of PegIntron, which have been in decline since 2008, and if sales of PegIntron continue to decline or sales of other drug products for which we receive royalty revenues materially decline, our results of operations and financial position could be materially harmed.
· We may not be able to sustain profitability and we may incur losses over
the next several years. · If we do not continue to realize the expected benefits from the
reduction in our workforce that was completed in 2013 and from future
cost savings initiatives that we may implement, the value of the Company
and our assets and the market price of our common stock could materially
decline. · As a result of the reduction in our workforce that was completed in 2013, we have reallocated certain employment responsibilities and
outsourced certain corporate functions, which make us more dependent on
third-parties to perform these corporate functions.
· We may be subject to a variety of types of product liability or other
claims based on allegations that the use of our product candidates by
participants in our clinical trials has resulted in adverse effects, and
our insurance may not cover all product liability or other claims. · We depend on patents and proprietary rights, which may offer only
limited protection against potential infringement and the development of
· We are party to license and other collaboration agreements that contain
complex commercial terms that could result in disputes, litigation or indemnification liability that could cause the value of the Company and our assets and the market price of our common stock to decline.
· We are party to license agreements whereby we may receive royalties from
products subject to regulatory approval.
· The price of our common stock has been, and may continue to be, volatile.
· The declaration of dividends is within the discretion of our Board of Directors, subject to any applicable limitations under
Delawarecorporate law. Our ability to pay dividends in the future depends on, among other things, our future royalty revenues, which are expected to
decrease over time, as well as our ability to manage expenses, including
costs relating to our ongoing operations. · Events with respect to our capital stock could cause the number of
shares of our common stock outstanding to increase and thereby cause our
stockholders to suffer significant dilution.
· Anti-takeover provisions in our charter documents and under
corporate law may make it more difficult to acquire us, even though such acquisitions may be beneficial to our stockholders. · The issuance of preferred stock may adversely affect rights of our common stockholders.
· A small number of stockholders own a large percentage of our common
stock and can influence the outcome of matters submitted to our stockholders for approval. · If we are unable to satisfy the continued listing requirements of The
NASDAQ Stock Market, our common stock could be delisted and the price and liquidity of our common stock may be adversely affected.
· We received a Notice of Proposed Adjustment from the Internal Revenue
Service. We disagree with such proposed adjustment and we are currently
in the process of providing more facts and documentation to support our position and we will appeal this adjustment, if necessary. However, if
effect on our financial position.
· If we experience an "ownership change," as defined in Section 382 of the
Internal Revenue Code of 1986, as amended, our ability to fully utilize
our net operating loss carryforwards ("NOLs") on an annual basis will be
substantially limited, and the timing of the usage of the NOLs could be
substantially delayed, which could therefore significantly impair the value of those benefits. A more detailed discussion of these risks and uncertainties 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, 2013, as updated in "Item 1A. Risk Factors" of our subsequent quarterly reports on Form 10-Q. These risks and uncertainties and other factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. As such, no assurance can be given that the future results covered by the forward-looking statements will be achieved. All information in this Quarterly Report on Form 10-Q is as of the date of this report, unless otherwise indicated, and we undertake no duty to update this information. 19