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 meanEnzon Pharmaceuticals, Inc. and its subsidiaries. The following discussion of our financial condition and results of operations should be read together with our consolidated financial statements and notes to those statements included elsewhere in this Quarterly Report on Form 10-Q and our 2019 Annual Report
on Form 10-K.
Forward-Looking Information and Factors That May Affect Future Results
The following discussion contains forward-looking statements within the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in the following discussion, 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 "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 the risks and uncertainties set forth in Item 1A. Risk Factors in our 2019 Annual Report on Form 10-K. These risks and uncertainties 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.
The percentage changes throughout the following discussion are based on amounts stated in thousands of dollars reflected in this section.
Overview
We are positioned as a public company acquisition vehicle, where we can become an acquisition platform and more fully utilize our net operating loss carryforwards ("NOLs") and enhance stockholder value.
InSeptember 2020 , we initiated a Rights Offering for our common and preferred stock (see below and Note 15 to our Condensed Consolidated Financial Statements), which closed inOctober 2020 , and we realized$43.6 million in gross proceeds. This has enabled us to embark on our plan to realize the value of our more than$100 million net NOLs by acquiring potentially profitable businesses or assets. To protect the NOLs, inAugust 2020 , our Board of Directors adopted a Section 382 rights plan (see Note 14 to our Condensed Consolidated Financial Statements). Historically, we have received royalty revenues from licensing arrangements with other companies primarily related to sales of certain drug products that utilized Enzon's proprietary technology. In recent years, we have had no clinical operations and limited corporate operations. We have a series of licensing agreements in the drug Vicineum, which, if approved, will potentially generate milestone and royalty payments to us in the future. We cannot assure you that we will earn material future royalties or milestones. Prior to 2017, we received royalty revenues from sales of PegIntron, which is marketed by Merck & Co., Inc. ("Merck"). In 2019 and 2020 net royalties from PegIntron have not been significant. There is a dispute with Merck regarding royalties (see Note 12 to our Condensed Consolidated Financial Statements). We have certain royalty agreements regarding SC Oncaspar and certain other drugs. Since 2013, we had planned, to distribute excess cash to stockholders from our royalty revenues. In 2016, our Board of Directors adopted a Plan of Liquidation and Dissolution (the "Plan"). Following each subsequent periodic assessment, our Board of Directors postponed seeking shareholder approval for the Plan, and onNovember 9, 2020 , our Board of Directors withdrew and terminated the Plan as the result of its successful rights offering (see above and Notes 11 and 15 to our Condensed Consolidated Financial Statements).
We maintain our principal executive offices at
OnAugust 4, 2020 , our Board of Directors appointed Mr.Jordan Bleznick and Mr.Randolph C. Read as directors to the Board, effectiveAugust 4, 2020 , to fill the vacancies created by the resignations of Mr.Jonathan Christodoro and Dr.Odysseas Kostas as of the same date. Messrs. Bleznick and Read will each serve until the next annual meeting of our stockholders and until such director's successor is elected and qualified, subject to such director's earlier death, resignation, disqualification or removal.Mr. Bleznick was appointed by our Board of Directors after discussions withCarl C. Icahn , one of the Company's largest stockholders, and after consideration by theGovernance and Nominating Committee . There are no arrangements or understandings betweenMr. Bleznick and any other persons pursuant to whichMr. Bleznick was selected as a director.Mr. Read was appointed by the Board after consideration by theGovernance and Nominating Committee . There are no arrangements or understandings betweenMr. Read and any other persons pursuant to whichMr. Read was selected as a director. Following the new Board of Directors' appointments,Mr. Read was elected as Chairman of the Board. The Board of Directors also appointed Messrs. Bleznick and Read to itsFinance and Audit Committee , replacingMr. Christodoro andDr. Kostas , having determined that each meets the requirements for financial literacy and independence that the Board of Directors has used to select members of that committee.Jennifer McNealey , who also serves as a director on the Board of Directors, is the other member of theFinance and Audit Committee . Messrs. Bleznick and Read were each determined by the Board of Directors to qualify as an "audit committee financial expert," as defined in Item 407(d)(5) of Regulation S-K. Mr. Read was elected as the Chairman of theFinance and Audit Committee . InNovember 2020 ,Mr. Bleznick resigned from theFinance and Audit Committee , but maintains his position on the Board of Directors.
15 Section 382 Rights Plan OnAugust 14, 2020 , our Board of Directors adopted a Section 382 rights plan and declared a dividend distribution of one right for each outstanding share of the Company's common stock to stockholders of record at the close of business onAugust 24, 2020 . Accordingly, holders of the Company's common stock own one preferred stock purchase right for each share of common stock owned by such holder. The rights are not immediately exercisable and will become exercisable only upon the occurrence of certain events as set forth in the Section 382 rights plan. If the rights become exercisable, each right would initially represent the right to purchase from us one one-thousandth of a share of our Series A-1 Junior Participating Preferred Stock, par value$0.01 per share, for a purchase price of$1.20 per right. If issued, each fractional share of Series A-1 Junior Participating Preferred Stock would give the stockholder approximately the same dividend, voting and liquidation rights as does one share of the Company's common stock. However, prior to exercise, a right does not give its holder any rights as a stockholder of the Company, including any dividend, voting or liquidation rights. The rights will expire on the earliest of (i) the close of business onAugust 13, 2021 (unless that date is advanced or extended by the Board of Directors), (ii) the time at which the rights are redeemed or exchanged under the Section 382 rights plan, (iii) the close of business on the day of repeal of Section 382 or any successor statute or (iv) the close of business on the first day of a taxable year of the Company to which our Board of Directors determines that no net operating loss carryforward may be carried
forward. The Rights Offering OnSeptember 1, 2020 , the our Board of Directors approved a Rights Offering, by which we distributed, at no charge to all holders of our common stock onSeptember 23, 2020 (the "Record Date") transferable subscription rights to purchase Units at a subscription price per Unit of$1,090 . In the Rights Offering each stockholder received one subscription right for every share of common stock owned at5:00 p.m. ,New York City time, on the Record Date. For every 1,105 subscription rights held, a stockholder was entitled to purchase one Unit at the subscription price. Each Unit consisted of newly designated Series C preferred stock, par value$0.01 per share, and 750 shares of the Company's common stock. It is our intention to use the approximately$43 million of net proceeds from the Rights Offering to position us as a public company acquisition vehicle, where we can become an acquisition platform and more fully utilize our net operating loss carryforwards and enhance stockholder value. We do not, however, have any current plans, arrangements or understandings with respect to any acquisitions or investment and we are, currently, not involved in any negotiations with respect to any such transactions. On an annual basis, the Company's Board of Directors may, at its sole discretion, cause a dividend with respect to the Series C Preferred Stock to be paid in cash to the holders in an amount equal to 3% of the liquidation preference as in effect at such time (initially$1,000 per share). If the dividend is not so paid in cash, the liquidation preference will be adjusted and increased annually by an amount equal to 5% of the liquidation preference per share as in effect at such time, that is not paid in cash to the holders on such date. Holders of Series C preferred stock do not have any voting rights and the Series C preferred stock is not convertible into shares of our common stock. The initial liquidation value of the Series C preferred stock will be$1,000 per share. On or afterNovember 1, 2022 , we may redeem the Series C preferred stock at any time, in whole or in part, based on the liquidation preference per share as in effect at such time. Holders of Series C preferred stock have the right to demand that we redeem their shares in the event that we undergo a change of control. OnSeptember 1, 2020 , we entered into an Investment Agreement withIcahn Capital LP in connection with the Rights Offering.Icahn Capital LP , together with its affiliates, owned approximately 15% of our outstanding shares of common stock and is one of our largest stockholders. Subject to the terms and conditions of the Investment Agreement,Icahn Capital LP agreed to subscribe for its pro-rata share of the Rights Offering and to purchase all units that remain unsubscribed for at the expiration of the Rights Offering to the extent that other holders elected not to exercise all of their respective subscription rights. No fees were paid by us toIcahn Capital LP in consideration of such investment commitment. In connection with the execution of the Investment Agreement, the parties agreed to terminate the Standstill Agreement, datedDecember 18, 2016 , by and between us,Icahn Capital LP and the other affiliated parties identified therein, so that it shall be of no further force or effect; and waive the applicability of Section 203 of theDelaware General Corporation Law of theState of Delaware toIcahn Capital LP and its affiliates. In addition, we agreed to use our best efforts to register for resale all of the shares of our common stock then held byIcahn Capital LP and its affiliates following the closing of the Rights Offering. The subscription period for the Rights Offering ended onOctober 9, 2020 . OnOctober 14, 2020 , we reported that stockholders exercised subscription rights to purchase 6,694 units. Pursuant to the Investment Agreement,Icahn Capital LP subscribed for 5,971 of such units (its pro-rata share of the Rights Offering). In addition, pursuant to its investment commitment,Icahn Capital LP purchased all 33,306 units that remained unsubscribed for at the expiration of the Rights Offering. As a result of such purchasesIchan Capital LP and its affiliates
own 48.6% of our common stock. As a result of the sale of all 40,000 units available for purchase in the Rights Offering, the Company has 40,000 shares of Series C preferred stock outstanding and an aggregate of 74,214,603 shares of common stock outstanding following the Rights Offering and realized gross proceeds of$43.6 million .
We believe that the completion of the Rights Offering will not limit the use of our net operating loss carryforwards due to any Section 382 limitations.
Plan of Liquidation and Dissolution
OnFebruary 4, 2016 , our Board of Directors adopted the Plan of Liquidation and Dissolution (the "Plan"), pursuant to which we would, subject to obtaining requisite stockholder approval, be liquidated and dissolved in accordance with Sections 280 and 281(a) of the General Corporation Law of theState of Delaware . Following each subsequent periodic assessment, our Board of Directors postponed seeking stockholder approval of the Plan. OnNovember 9, 2020 , our Board of Directors withdrew and terminated the Plan of Liquidation and Dissolution as a result of the completion of the Rights Offering (see Note 15 to our Condensed Consolidated Financial Statements). 16
Throughout this Management's Discussion and Analysis, the primary focus is on our results of operations, cash flows and financial condition. The percentage changes throughout the following discussion are based on amounts stated in
thousands of dollars. Results of Operations Revenues:
Royalties (in thousands of dollars):
Three Months Ended Nine Months Ended September 30, September 30, % % 2020 Change 2019 2020 Change 2019 Royalty revenues$ 8 30 %$ 2 $ 18 89 %$ 158
Royalty revenues from sales of PegIntron by Merck amounted to approximately$8,000 for the three months endedSeptember 30, 2020 , as compared to$2,000 during the corresponding period in the prior year. These PegIntron royalties accounted for 100% and 100% of the Company's total royalty revenues for the three months endedSeptember 30, 2020 and 2019, respectively, and approximately 100% and 100% (approximately$91,000 , inclusive of downward revenue adjustment of approximately$51,000 , related to the amounts of returns and rebates exceeding the amounts of royalties earned in the first quarter of 2019) of the Company's total royalty revenues for the nine-month periods endedSeptember 30, 2020 and 2019, respectively. The effects of such downward revenue adjustments were recorded as decreases of royalty revenues as discussed in Note 1 to the Condensed Consolidated Financial Statements. Royalty revenues from Merck have been declining sharply. There are multiple oral drug therapies, both available and in development, that have been effective for treatment of hepatitis C that do not require interferon. As a result, it is likely that sales of PegIntron-related products will continue their declining trend and we expect to receive little or no future royalties from Merck. Our right to receive royalties from sales of PegIntron expired in theU.S. in 2016, expired inEurope in 2018 and expired inMalaysia onJune 30, 2020 , and are expiring inJapan
in 2021 andChile in 2024.
Merck has not yet reported royalty revenues earned by us for product sales
and/or recoupments for returns and rebates for the quarter ended
Royalty revenues for the nine months endedSeptember 30, 2019 , include a one-time, non-refundable, payment of approximately$65,000 fromNovartis Pharma AG in payment of a worldwide, royalty free non-exclusive license to certain Canadian patents. There was no such payment during the current year's comparable period. Operating Expenses:
General and Administrative(in thousands of dollars):
Three Months Ended September 30, Nine Months Ended September 30, % % 2020 Change 2019 2020 Change 2019 General and administrative$ 415 27 %$ 327 $ 901 3 %$ 873
General and administrative expenses increased by approximately$28,000 , or 3%, to$901,000 for the nine months endedSeptember 30, 2020 from$873,000 for the first nine months of 2019. The increase in expense is substantially attributable to the increase in legal fees, significantly in connection with the Section 382 Rights Plan, partially offset by the decrease in accounting and filing fees. General and administrative expenses increased by approximately$88,000 , or 27%, to$415,000 for the three months endedSeptember 30, 2020 from$327,000 for the third quarter of 2019. The increase in expense is substantially attributable to the increase in legal fees and consulting fees, significantly in connection with the Section 382 Rights Plan. Tax Expense:
We incurred a tax expense of approximately$2,000 in the first nine months of 2020 and$2,000 during the prior comparable period to reflectNew Jersey state minimum taxes.
Liquidity and Capital Resources
Our current source of liquidity is our existing cash on hand, which includes the approximately$43 million of net proceeds from our Rights Offering (see Note 15 to our Condensed Consolidated Financial Statements). While we no longer have any research and development activities, we continue to retain rights to receive royalties and milestone payments from existing licensing arrangements with other companies. We believe that our existing cash on hand will be sufficient to fund our operations, at least, throughOctober 2021 . Our future royalty revenues are expected to be de minimis over the next several years and there can be no assurance that we will receive any royalty or other revenues. Cash was$5.3 million as ofSeptember 30, 2020 , as compared to$5.4 million as ofDecember 31, 2019 . The decrease of approximately$0.1 million was primarily attributable to our nine-month net loss of$0.9 million and$0.3 million of payments for deferred stock offering expenses, offset by$1.0 million net effect of cash provided by operating activities resulting from the collection of an approximately$1.0 million refundable tax credits receivable. 17
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
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 inthe United States ("U.S. GAAP"). All applicableU.S. GAAP accounting standards effective as ofSeptember 30, 2020 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 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.
Deferred Stock Offering Expenses
We classify amounts related to the Rights Offering (see Note 15 to the Condensed Consolidated Financial Statement.) not closed as of the balance sheet date as Deferred Stock Offering Expenses. Such costs will be reclassified as an offset toAdditional Paid-in-Capital upon completion of the Rights Offering. 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 for the sale of our former specialty pharmaceutical business are recognized as revenue when the milestone has been achieved, 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. 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 that some portion or all of the deferred tax assets will not be realized. As ofSeptember 30, 2020 , 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, will not be realized. Although there can be no certainly of such, if our acquisition strategy is successful and future profitability is projected, the valuation allowance will be reduced, accordingly. 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. 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:
· We may be unsuccessful in using the net proceeds of the Rights Offering
to position the Company as a public company acquisition vehicle
and
realizing the expected benefits of the Rights Offering. There
can be no
assurance we will be successful in our current strategy and if
we do
not utilize the proceeds in connection with an acquisition, our
Board
of Directors will have considerable discretion in the use of
such
proceeds, which could vary substantially from their current
intended
use. The failure by the Board and the Company to apply these
proceeds
effectively could have a material and adverse effect on our
business,
financial condition and results of operations of the Company.
· Until 2017, in recent years, we derived most of our royalty revenues
from continued sales of PegIntron, which have been in sharp
decline. In
addition, our right to receive royalties onU.S. and European
sales of
PegIntron expired in 2016 and 2018, respectively, which has
negatively
impacted our royalty revenues. · We expect to continue to incur losses until such time as our acquisition strategy becomes successful, There can be no
assurance that
profitability can be attained. · Our rights to receive royalties on sales of PegIntron and sales of other drug products have expired in various jurisdictions and
will, by
2024, expire world-wide. We currently do not anticipate any
significant
income until such time as our acquisition strategy becomes
successful
and we become profitable. The can be no assurance as to the
success of
our acquisition strategy or that profitability will be attained.
· We expect that we will not realize our deferred income tax assets until
such time as our acquisition strategy becomes successful and we
become
profitable and generate taxable income. There can be no
assurance as to
the success of our acquisition strategy or that profitability will be attained or that we will generate taxable income. · The unprecedented actions taken globally to control the spread of COVID-19, as well as the uncertain timing for an effective
treatment or
vaccine for the virus, may materially and adversely affect our
future
right to receive licensing fees, milestone payments and
royalties on
product candidates that are being developed by third parties.
· We have reallocated all employment responsibilities and outsourced all
corporate functions, which makes 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 previously conducted clinical trials has
resulted
in adverse effects, and our insurance may not cover all product liability or other claims.
· Our revenues largely depend on proprietary rights, which may offer only
limited protection against the development of competing products.
· We are party to license agreements whereby we may receive royalties and
or milestone payments from products subject to regulatory approval.
· The price of our common stock has been, and may continue to be, volatile.
· Our common stock is quoted on the OTCQX market of the OTC Markets
Group, Inc. , which has a very limited trading market and,
therefore,
market liquidity for our common stock is low and our
stockholders'
ability to sell their shares of our common stock may be limited. · The declaration of dividends on our common stock is within the discretion of our Board of Directors, subject to any applicable limitations underDelaware corporate law and the terms of our outstanding Series C preferred stock. Our ability to pay
dividends in
the future depends on, among other things, our future revenues, which are expected to be minimal, if any, over the next several years, except to the extent that our acquisition strategy is successful, of which there can be no assurance, as well as our ability to manage
expenses,
including costs relating to our ongoing operations.
· Anti-takeover provisions in our charter documents and under
corporate law as well as our Section 382 rights plan 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. 19 A more detailed discussion of these risks and uncertainties and other factors that could affect results is contained in our filings with theU.S. Securities and Exchange Commission , including our Annual Report on Form 10-K for the year endedDecember 31, 2019 . 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.
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