The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(1)
|
Description of Business
|
Enzon Pharmaceuticals, Inc.
(together with its subsidiaries, the “Company,” “Enzon,” “we” or “us”) is positioned as
a public company acquisition vehicle, where it can become an acquisition platform and more fully utilize its net operating loss carryforwards
(“NOLs”) and enhance stockholder value.
In September 2020, the Company initiated a rights offering for
its common and preferred stock (see below and Note 12 to our Condensed Consolidated Financial Statements), which closed in October 2020,
and it realized $43.6 million in gross proceeds. This has enabled the Company to embark on its plan to realize the value of its approximately
$103 million net operating loss carryforwards (“NOLs”) by acquiring potentially profitable businesses or assets. To protect
the NOLs, in August 2020, the Company’s Board of Directors adopted a Section 382 rights plan (see Note 11 to our Condensed
Consolidated Financial Statements).
Historically, the Company
had 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, the Company has had no clinical operations and limited corporate operations.
Enzon has a marketing agreement relating to the drug Vicineum, which, if approved, will, potentially, generate milestone and royalty payments
to it in the future. Enzon cannot assure you that it will earn material future royalties or milestones.
The
Company has a marketing agreement with Micromet AG, now part of Amgen, Inc. (the “Micromet Agreement”), pursuant to
which the Company may be entitled to a share of certain milestone and royalty payments if Vicineum, a drug being developed by Sesen Bio, Inc.
(“Sesen”), is approved for the treatment of non-muscle invasive bladder cancer. In a press release dated February 16,
2021, Sesen announced that the U.S. Food and Drug Administration (the “FDA”) has accepted for filing Sesen’s Biologic
License Application (“BLA”) for Vicineum. The FDA further granted Priority Review, with a target Prescription Drug User Fee
Act (“PDUFA”) date for a decision on the BLA of August 18, 2021. Accordingly, the Company earned a milestone of $409,430
in the first quarter of 2021. The amount of $344,638 was received during that quarter and the balance of $64,792 was recorded as a receivable
as of March 31, 2021. In a filing with the U. S. Securities and Exchange Commission (“SEC”) in March 2021, Sesen
noted that it had received notice from the European Medicines Agency (“EMA”) that its Marketing Authorization Application
(“MMA”) for Vicineum was found to be valid and the review procedure has officially started. Due to the challenges associated
with developing and obtaining approval for drug products, and the lack of involvement by the Company in the development and approval
process, there is substantial uncertainty as to whether the Company will receive additional milestone or any royalty payments under the
Micromet Agreement. The Company will not recognize revenue until all revenue recognition
requirements are met.
The Company maintains its
principal executive offices at 20 Commerce Drive, Suite 135, Cranford, New Jersey 07016.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(2)
|
Basis of Presentation
|
Interim Financial Statements
The accompanying unaudited
condensed consolidated financial statements have been prepared from the books and records of the Company in accordance with United States
generally accepted accounting principles (U.S. GAAP) for interim financial information and Rule 10-01 of Regulation S-X promulgated
by the U.S. Securities and Exchange Commission (the “SEC”). Accordingly, these financial statements do not include all of
the information and footnotes required for complete annual financial statements. Interim results are not necessarily indicative of the
results that may be expected for the full year. Interim condensed consolidated financial statements should be read in conjunction with
the consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2020.
Principles of Consolidation
The condensed consolidated
financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions
have been eliminated as part of the consolidation.
Use of Estimates
The preparation of consolidated
financial statements in conformity with accounting principles generally accepted in the United States of America requires management to
make estimates and assumptions that affect reported amounts of assets and liabilities, disclosures of contingent assets and liabilities
at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. These estimates
include legal and contractual contingencies and income taxes. Although management bases its estimates on historical experience, relevant
current information and various other assumptions that are believed to be reasonable under the circumstances, actual results could differ
from these estimates.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(2)
|
Basis of Presentation (continued)
|
Revenue Recognition
Royalty revenues from the
Company’s agreements with third parties are recognized when the Company can reasonably determine the amounts earned. In most cases,
this will be upon notification from the third-party licensee, which is typically during the quarter following the quarter in which the
sales occurred. The Company does not participate in the selling or marketing of products for which it receives royalties. No provision
for uncollectible accounts is established upon recognition of revenues.
Contingent payments due under
the asset purchase agreement for the sale of the Company’s former specialty pharmaceutical business are recognized as revenue 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.
Income Taxes
Income taxes are accounted
for under the asset and liability method. 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. The effect of a change in tax
rates or laws on deferred tax assets and liabilities is recognized in operations in the period that includes the enactment date of the
rate change. A valuation allowance is established to reduce the deferred tax assets to the amounts that are more likely than not to be
realized from operations.
Tax benefits of uncertain
tax positions are recognized only if it is more likely than not that the Company will be able to sustain a position taken on an income
tax return. The Company has no liability for uncertain tax positions. Interest and penalties, if any, related to unrecognized tax benefits,
would be recognized as income tax expense.
(3)
|
Recent Accounting Pronouncements
|
Recent Accounting Standards Updates (“ASUs”)
issued by the Financial Accounting Standards Board (“FASB”) and guidance issued by the SEC did not, or are not believed by
management to, have a material effect on the Company’s present or future Condensed Consolidated Financial Statements.
(4)
|
Financial Instruments and Fair Value
|
The carrying values of cash
and cash equivalents, royalty receivable, other current assets, accounts payable, accrued expenses and other current liabilities in the
Company’s consolidated balance sheets approximated their fair values at March 31, 2021 and 2020 due to their short-term nature.
As of March 31, 2021 and December 31, 2020, the Company held cash equivalents aggregating approximately $43.6 million.
(5)
|
Supplemental Cash Flow Information
|
The Company made no income tax payments during the three months ended
March 31, 2021 and 2020, respectively. There were no interest payments made during the three months ended March 31, 2021 or
2020.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(6)
|
Income (Loss) Per Common Share
|
Basic income (loss) per common
share is computed by dividing the net income (loss), less any dividends, accretion or reduction or redemption on our Series C Preferred
Stock, 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 or performance
vesting period has been completed.
For purposes of calculating
diluted earnings per common share, the denominator normally 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. Because a loss was incurred
in each of the quarters ended March 31, 2021 and 2020, common stock equivalents would be anti-dilutive and, accordingly, were excluded
from the calculation of diluted loss per share in each of the periods. Dilutive common stock equivalents potentially include stock options
and nonvested shares using the treasury stock method and shares issuable under the employee stock purchase plan. During each of
the three-month periods ended March 31, 2021 and 2020, there were no common stock equivalents. Loss per common share information
is as follows (in thousands, except per share amounts) for the three months ended March 31, 2021 and 2020:
|
|
Three months ended March 31,
|
|
|
|
2021
|
|
|
2020
|
|
Income (Loss) Per Common Share – Basic and Diluted:
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
11
|
|
|
$
|
(242
|
)
|
Dividends on Series C preferred stock
|
|
$
|
(506
|
)
|
|
$
|
-
|
|
Net loss available to common shareholders
|
|
$
|
(495
|
)
|
|
$
|
(242
|
)
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding
|
|
|
74,215
|
|
|
|
44,215
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share
|
|
$
|
(0.01
|
)
|
|
$
|
(0.01
|
)
|
At March 31, 2021 and
2020, options for 25,000 and 41,787 shares, respectively, were outstanding that have been excluded from the calculation of diluted weighted-average
number of shares outstanding, as they would be anti-dilutive, since the respective options’ strike price was greater than the market
price of the respective shares.
(7)
|
Stock Based Compensation
|
Stock Options and Restricted Stock Units (RSUs
or Nonvested Shares)
During the quarter ended March 31,
2021 no options were granted and the Company incurred no stock-based compensation expense. No RSUs were granted during the three months
ended, or outstanding as of, March 31, 2021.
There were no options granted
during the three months ended March 31, 2020 and no RSUs were granted during, or outstanding as of, the three months ended March 31,
2020. The Company uses historical data to estimate forfeiture rates.
Activity related to stock
options and nonvested shares during the three months ended March 31, 2021 and related balances outstanding as of that date are reflected
below:
|
|
Stock Options
|
|
Outstanding at January 1, 2021
|
|
|
25,000
|
|
Granted
|
|
|
-
|
|
Exercised and vested
|
|
|
-
|
|
Expired and forfeited
|
|
|
-
|
|
Outstanding at March 31, 2021
|
|
|
25,000
|
|
|
|
|
|
|
Options vested and expected to vest at March 31, 2021
|
|
|
25,000
|
|
|
|
|
|
|
Options exercisable at March 31, 2021
|
|
|
25,000
|
|
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
During each of the three-month
periods ended March 31, 2021 and 2020, the Company recorded approximately $2,000 of income tax expense for New Jersey state income
tax.
ASC 740 requires the reduction of deferred tax assets by a valuation
allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not
be realized. For the period ended December 31, 2020, the Company believed that it was more likely than not that future taxable income
would not exist to utilize some or all of its deferred tax assets. However, although there can be no certainty of such, if the Company’s
acquisition strategy is successful and future taxable income is projected, among other things, the valuation allowance will be reevaluated.
Accordingly, it recorded a valuation allowance in the amount of its total deferred tax assets for the period ended December 31, 2020.
In 2021, the Company projects a taxable loss before utilization of NOLs. Due to the valuation allowance placed on its deferred tax assets,
the deferred tax expense resulting from the usage and/or expiration of deferred tax assets was offset by a corresponding deferred tax
benefit from a reduction in valuation allowance, and the Company recorded no deferred tax expense as of March 31, 2021. The Company
intends to acquire profitable businesses, entities or revenue streams that will generate sufficient income so that it can utilize its
approximately $103 million NOLs. To date, no actionable acquisition candidates have been identified and, while the Company expects that,
ultimately, it will be successful in realizing the value of its NOLs, the Company cannot provide assurance that it will be able to do
so.
Management of the Company
will continue to assess the need for this valuation allowance and will make adjustments when or if appropriate.
At March 31, 2021, the
Company had federal NOLs of approximately $103 million, of which approximately $100.6 million will expire in the years 2025 through 2036,
and New Jersey state NOLs of approximately $25.8 million that expire in the years 2031 through 2041. Under the Tax Cuts and Jobs Act,
net operating losses generated in tax years beginning after December 31, 2017 have an unlimited carryforward period, and the amount
of net operating loss allowed to be utilized each year is limited to 80% of taxable income. The Coronavirus Aid, Relief and Economic
Security Act, which was signed into law on March 27, 2020, suspended the 80% limitation for
taxable years 2018 through 2020 and provided for a five-year carryback period for net operating losses for those years. Net
operating losses generated in 2017 and earlier continue to be carried forward for 20 years and have no 80% limitation on utilization.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(9)
|
Commitments and Contingent Liabilities
|
In December 2019, an
outbreak of a novel strain of coronavirus (COVID-19) was reported in Wuhan, China. On March 11, 2020, the World Health
Organization characterized the global spread of COVID-19 as a pandemic. In an effort to slow the spread of the virus, the United States
and many other countries around the world imposed restrictions on non-essential work activities, travel and mass gatherings. Although
these restrictions have been eased in some areas, it is not known whether these lockdowns and other restrictions will be reintroduced,
especially in light of the uncertainty regarding cases in the United States, when they will end or the ultimate impact these unprecedented
actions will have on the Company’s financial condition and prospects. At the present time, the Company’s business activities
have been largely unaffected by COVID-19 restrictions as the Company’s workforce is comprised solely of independent contractors
who are able to perform their duties remotely. However, these restrictions may impact the third parties who are responsible for obtaining
final approval of and manufacturing product candidates for which the Company shares the right to
receive licensing fees, milestone payments and royalty revenues. If those third parties are required to curtail their business activities
for a significant time, or if global supply chain disruptions impact their ability to procure needed resources, raw materials
or components, the Company’s right to receive licensing fees, milestone payments or royalties could be materially and adversely
affected. Additionally, the development timeline for product candidates being developed by third parties that are pending FDA or other
regulatory approval could be delayed if the agency is required to shift resources to the review and approval of candidates for treatment
of COVID-19. In addition, the effects of the COVID-19 pandemic, including the current global challenges, may negatively impact the Company’s
search for a business acquisition or investment, as well as negatively impacting the business and/or results of operations of any target
business which the Company acquires or in which it invests.
The Company has been involved
in various claims and legal actions arising in the ordinary course of business. In the opinion of management, the ultimate disposition
of these matters will not have a material effect on the Company’s consolidated financial position, results of operations, or liquidity.
Due to returns, rebates and
other adjustments, at various times, Merck has notified the Company of its expected repayment of previously paid royalties. As of December 31,
2020, according to Merck, the Company had a net liability to Merck (net of a 25% royalty interest that the Company had previously sold)
aggregating approximately $302,000. This was based on Merck’s assertions regarding the net result of overpayments, rebates and returns
related to prior periods sales of PegIntron. Merck expected to be repaid for such overpayments through reductions of future royalties
earned by the Company. During the three months ended March 31, 2021, Merck notified the Company of an additional amount they believe
is owed to them approximating $27,000. Accordingly, at March 31, 2021, the Company recorded a net payable to Merck of approximately
$329,000 due to such royalty overpayment claims by Merck. The Company believes that it will receive no additional royalties from Merck.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(11)
|
Section 382 Rights Plan
|
On August 14, 2020, in
an effort to protect stockholder value by attempting to protect against a possible limitation on the Company’s ability to use its
NOLs, the Company’s 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 on August 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 the Company one one-thousandth of a share of the Company’s 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 on August 13, 2021 (unless
that date is advanced or extended by the Board), (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 of the Internal Revenue Code or any successor statute
or (iv) the close of business on the first day of a taxable year of the Company to which the Company’s Board of Directors determines
that no NOLs may be carried forward. The Company is seeking stockholder ratification of the Section 382 rights plan at the Company’s
2021 annual meeting scheduled for June 2, 2021.
In September 2020, the
Company’s Board of Directors approved a Rights Offering (the “Rights Offering”), by which the Company distributed, at
no charge to all holders of its common stock on September 23, 2020 (the “Record Date”), transferable subscription rights
to purchase units (“Units”) at a subscription price per Unit of $1,090. In the Rights Offering, each stockholder on the Record
Date received one subscription right for every share of common stock owned 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 one share of newly designated Series C
Preferred Stock, par value $0.01 per share, and 750 shares of the Company’s common stock. The subscription period for the Rights
Offering ended on October 9, 2020.
As a result of the sale of all 40,000 Units available for purchase
in the Rights Offering, the Company received approximately $43.6 million of gross proceeds and had 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.
Pursuant to the Rights Offering,
Icahn Capital LP, together with its affiliates, subscribed for 5,971 Units (its pro-rata share of the Rights Offering) representing the
purchase of 4,478,250 shares of the Company’s common stock and 5,971 shares of Series C Preferred Stock. Icahn Capital LP also
purchased all Units that remained 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, which totaled 33,306 Units representing the purchase of 24,979,500 shares
of common stock and 33,306 shares of Series C Preferred Stock. Following the completion of the Rights Offering, Icahn Capital LP, together
with its affiliates, owned approximately 48% of the Company’s outstanding common stock and approximately 98% of the Company’s
outstanding Series C Preferred Stock.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(13)
|
Series C Preferred Stock
|
In October 2020, the
Company issued 40,000 shares of Series C Preferred Stock for an aggregate purchase price of $40.0 million.
On December 31st
of each year, 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. The
Company’s Board of Directors did not declare a dividend as of December 31, 2020 or subsequently. Accordingly, dividends on
the Series C Preferred Stock were accrued at 5% at December 31, 2020, aggregating approximately $460,000. Accordingly, as of
December 31, 2020, the cumulative liquidation value of the Series C Preferred Stock was approximately $40,460,000 ($1,012 per share).
As of March 31, 2021,
pursuant to the terms of the Series C Preferred Stock, the Company’s Board of Directors had not declared a cash dividend on the
Series C Preferred Stock as dividends on such stock are only declared and paid once a year on or about December 31st of
each year. As of March 31, 2021, the Board had not yet determined whether to declare a cash dividend at the end of 2021. Since a determination
has not been made, the Company has recorded a 5% increase (computed on a pro rata basis) to the liquidation preference of approximately
$12 per share of Series C Preferred Stock, aggregating approximately $506,000, for a cumulative liquidation value of approximately
$40,966,000 ($1,024 per share) as of March 31, 2021. Unless and until an amount in cash is paid to the holders of the Series C Preferred
Stock in an amount equal to the difference between the initial liquidation value ($1,000 per share) and the then-current liquidation value,
no dividends may be paid to holders of the Company’s common stock.
The Company may not repurchase
or redeem the Series C Preferred Stock prior to November 1, 2022. Since the redemption of the Series C Preferred Stock is contingently
or optionally redeemable, the Series C Preferred Stock has been classified in mezzanine equity on the Consolidated Balance Sheets.