Indicate by check mark if the registrant
is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
¨
Yes
x
No
Indicate by check mark if the registrant
is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act.
¨
Yes
x
No
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days.
x
Yes
¨
No
Indicate by check mark if disclosure of
delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s
knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment
to this Form 10-K.
x
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions
of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging
growth company” in Rule 12b-2 of the Exchange Act:
If an emerging growth company, indicate
by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act.
¨
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Act).
¨
Yes
x
No
The aggregate market value of the Common
Stock, $0.01 par value per share (“Common Stock”), held by non-affiliates of the registrant was approximately $11,495,797
as of June 29, 2018, based upon the closing sale price quoted on the OTCQX market of the OTC Markets Group, Inc. of $0.26 per share
reported for such date. Shares of Common Stock held by each executive officer and director of the registrant as of June 29, 2018
have been excluded in that such shares may be deemed to be owned by affiliates. This determination of affiliate status is not necessarily
a conclusive determination for other purposes.
There were 44,214,603 shares of Common
Stock issued and outstanding as of February 8, 2019.
If the registrant files a definitive proxy
statement relating to its 2019 Annual Meeting of Stockholders with the Commission not later than 120 days after December 31, 2018,
portions of such definitive proxy statement will be incorporated by reference into Part III of this Annual Report on Form 10-K
where indicated. However, if such definitive proxy statement is not filed with the Commission in such 120-day period, the registrant
will file an amendment to this Annual Report on Form 10-K with the Commission not later than the end of such 120-day period to
include the information required by Part III of Form 10-K.
Unless the context
requires otherwise, references in this Annual Report on Form 10-K to “Enzon,” the “Company,” “we,”
“us,” or “our” and similar terms mean Enzon Pharmaceuticals, Inc. and its subsidiaries.
This Annual Report
on Form 10-K contains forward-looking statements within the “safe harbor” provisions of the Private Securities Litigation
Reform Act of 1995. All statements contained in this Annual Report on Form 10-K, 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 of
this 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. All information in this Annual Report on Form 10-K speaks only as of the date
of the filing of this report, unless otherwise indicated. We do not intend to update this information to reflect events after the
date of this report.
PART I.
Item 1. Business
Enzon
Pharmaceuticals, Inc. (together with its subsidiaries, the “Company,” “Enzon,” “we” or
“us”), manages its sources of royalty revenues from existing licensing arrangements with other companies
primarily related to sales of certain drug products that utilize our proprietary technology. In 2018, the primary source of
our royalties and milestones revenues was
a milestone payment of $7
million due from Servier
IP UK Limited
(“Servier”).
On December 20, 2018, we were notified that the U.S. Food and Drug Administration (the “FDA”) approved
Servier’s
Biologics License Application (“BLA”) for
calaspargase
pegol – mknl (brand name ASPARLAS™), also known as SC Oncaspar. Pursuant to
an agreement originally
entered into with Sigma-Tau Finanziaria S.p.A. (“Sigma-Tau”) in November 2009, and ultimately assigned to
Servier, we earned a milestone payment of $7.0 million.
Accordingly, we recorded
revenue and a milestone receivable of $7.0 million at December 31, 2018.
In 2017, the primary source of our
royalties and milestones revenues was the revenues received from
Nektar Therapeutics, Inc.
(“Nektar”) pursuant to the
Second Amendment (“Nektar Second Amendment”) to our Cross-License
and Option Agreement (the “Nektar License Agreement”)
, which generated non-recurring
milestones revenues of $7.0 million (see below). The receipt of this $7.0 million satisfied
all future obligations of
royalty payments to us pursuant to the Nektar License Agreement.
Prior
to 2017, the
primary source of our royalty revenues was derived from sales of PegIntron, which is marketed by Merck &
Co., Inc. (“Merck”). The Company currently has no clinical operations and limited corporate operations.
We
have
no intention of resuming any clinical development activities or acquiring new sources of royalty revenues. Royalty
revenues from sales of PegIntron accounted for (2)% and 7% of our total revenues for the years ended December 31, 2018 and 2017,
respectively, net of the effects of adjustments for Merck’s recoupment of previously overpaid royalties. The effects of such
recoupments were recorded as a decrease of royalty revenues aggregating approximately $280,000 and $877,000 for the years ending
December 31, 2018 and 2017, respectively, as discussed in Note 4 to the Consolidated Financial Statements.
In March 2018, Merck
notified us that a downward adjustment of approximately $313,000 in royalties was necessary, resulting primarily from product returns
relating to periods prior to December 31, 2017. Accordingly, at December 31, 2017, we accrued a liability to Merck of approximately
$313,000 and partially offset that amount by the $88,000 that was due to us from Merck. Thus, we recorded a net payable to Merck
of approximately $225,000 at December 31, 2017. In January 2018, Merck paid the $88,000 to us, which increased the liability to
$313,000. During the second quarter, Enzon earned approximately $60,000 of royalties, which reduced the royalty payable to Merck
to $253,000. During the third quarter of 2018, Merck notified us of an additional recoupment of approximately $280,000, resulting
primarily from product rebates and returns. In the fourth quarter, Enzon earned approximately $94,000 of royalties. Accordingly,
the liability to Merck was $439,000 at December 31, 2018, as discussed in Note 4 to the Condensed Consolidated Financial Statements.
In April 2013, we announced
that we intended to distribute excess cash, expected to arise from royalty revenues, in the form of periodic dividends to stockholders.
On February 4, 2016, our Board adopted a Plan of Liquidation and Dissolution (the “Plan of Liquidation and Dissolution”),
the implementation of which has been postponed. (See Note 14 to the Consolidated Financial Statements.)
On
January 30, 2019, we entered into a letter agreement with Servier, a wholly owned indirect subsidiary of Les Laboratoires Servier,
in connection with the asset purchase agreement, dated as of November 9, 2009 (the “Asset Purchase Agreement”), by
and between Klee Pharmaceuticals, Inc., Defiante Farmacêutica, S.A. (“Defiante”) and Sigma-Tau, on the one hand,
and the Company, on the other hand. Under the letter agreement, Servier, as successor-in-interest to Defiante, has confirmed its
obligation to pay us a $7.0 million milestone payment related to SC Oncaspar as a result of the FDA’s December 20, 2018 approval
of calaspargase pegol – mknl (brand name ASPARLAS™) as a component of a multi-agent chemotherapeutic regimen for the
treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. In addition, under the
letter agreement, we agreed to waive Servier’s obligations to pursue the development of SC Oncaspar in Europe and the approval
of SC Oncaspar by the European Medicines Agency (“EMEA”) under the Asset Purchase Agreement, provided that the Company
is not waiving Servier’s obligation to make any applicable milestone payment to the Company upon EMEA approval, if any, of
SC Oncaspar. Servier is required to pay the $7.0 million milestone payment to us within three business days following the parties’
completion of procedures for claiming benefits under the double tax treaty between the United States and the United Kingdom. We
expect to receive the $7.0 million milestone payment from Servier by the third quarter of 2019. However, no assurance can be given
as to the timing of our receipt of the payment.
On June 26, 2017, we
entered into the Nektar Second Amendment, wherein Nektar agreed to buy-out all remaining payment obligations to us under the Nektar
License Agreement. In consideration for fully paid-up licenses under the Nektar License Agreement and for the dismissal with prejudice
of all claims and counterclaims asserted in the litigation with Nektar, Nektar agreed to pay us the sum of $7.0 million, which
satisfied all future obligations of royalty payments pursuant to the Nektar License Agreement. The entire amount due was received
during 2017. Accordingly, we recorded revenue of $7.0 million in 2017.
We
have a marketing agreement with Micromet AG (“Micromet”), now part of Amgen, Inc. (the “Micromet Marketing Agreement”),
that was entered into in 2004, under which Micromet is the exclusive marketer of the parties’ combined intellectual property
portfolio in the field of single-chain antibody technology. Under the Micromet Marketing Agreement, the parties agreed to
share, on an equal basis, in any licensing fees, milestone payments and royalties revenue received by Micromet in connection with
any licenses of the patents within the portfolio by Micromet to any third party during the term of the collaboration. To our knowledge,
Micromet has a license agreement with Viventia Biotech (Barbados) Inc. (“Viventia”), now part of Sesen Bio, Inc. (“Sesen”)
that was entered into in 2005, under which Micromet granted Viventia nonexclusive rights, with certain sublicense rights, for know-how
and patents allowing exploitation of certain single chain antibody products, which patents cover some key aspects of Vicinium,
one of Sesen’s drug candidates that is in Phase 3 clinical trials being evaluated for the treatment of patients with non-muscle
invasive bladder cancer. To our knowledge, Micromet is entitled to receive (i) certain milestone payments with respect to the filing
of a new drug application (“NDA”) for Vicinium with the FDA or the filing of a marketing approval application for Vicinium
with the EMEA; (ii) certain milestone payments with respect to the first commercial sale of Vicinium in the U.S. or Europe and
(iii) certain royalties on net sales for ten years from the first commercial sale of Vicinium. Pursuant to the Micromet Marketing
Agreement, we would be entitled to a 50% share of these milestone payments and royalties received by Micromet. Due to the challenges
associated with developing and obtaining approval for drug products, there is substantial uncertainty whether any of these milestones
will be achieved. We also have no control over the time, resources and effort that Sesen may devote to its programs and limited
access to information regarding or resulting from such programs. Accordingly, there can be no assurance that we will receive any
of the milestone or royalty payments under the Micromet Marketing Agreement. We will not recognize revenue until all revenue recognition
requirements are met.
Commencing on March
1, 2016, we changed the location of our principal executive offices to 20 Commerce Drive, Suite 135, Cranford, New Jersey, 07016.
We entered into an office service agreement with Regus Management Group, LLC (“Regus”) for use of office space at this
location effective March 1, 2016. Under the agreement, in exchange for our right to use the office space at this location, we were
required to pay Regus an initial service retainer of $2,418 and thereafter pay Regus a monthly fee of $1,209 until February 28,
2017. This agreement was renewed for two one-year extensions, until February 28, 2019, for a monthly fee of $1,259. In June 2018,
Regus and we agreed to end the lease on August 31, 2018, and replace it with an updated office service agreement. We entered into
an office service agreement with Regus for mailbox plus, telephone answering, and virtual office services effective September 1,
2018. Under the agreement, in exchange for the services provided by Regus, we were required to pay Regus an initial service retainer
of $259 and thereafter pay Regus a monthly fee of $259 until August 31, 2019.
Effective July 1, 2018,
we entered into an office rental agreement with Equinox Junior, LLC (“Equinox”) for use of office space at 3556 Main
Street, Manchester, VT, 05225. Under this agreement, in exchange for our right to use the office space at this location, we are
required to pay Equinox a monthly fee of $708 until June 30, 2019.
Plan of Dissolution
On February 4, 2016,
our Board of Directors adopted the Plan of Liquidation and Dissolution pursuant to which the Company 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 the State of Delaware. In approving the Plan of Liquidation and Dissolution, our Board of Directors had considered, among
other factors, the ability of the Company to obtain no-action relief from the Securities and Exchange Commission (the “SEC”)
to suspend certain of our reporting obligations under the Securities Exchange Act of 1934, as amended, and the anticipated cost
savings if such relief is granted by the SEC. Upon further review, our Board of Directors determined that it would be fair, advisable
and in the best interests of the Company and its stockholders to postpone seeking stockholder approval of the Plan of Liquidation
and Dissolution until a later time to be determined by our Board of Directors.
From
time to time, our Board of Directors reviews the Company’s status and prospects in deciding on the timing of dissolution
and liquidation of the Company pursuant to the Plan of Liquidation and Dissolution. If our Board of Directors determines to
seek stockholder approval of such plan and such plan is approved by our stockholders and implemented by the Company, it is expected
that our corporate existence will continue for the purpose of winding up our business and affairs for at least three years.
We have forecasted minimal or no royalty or milestone revenues for the foreseeable future. In light of the uncertainty as to whether
any of the milestones under the Micromet Marketing Agreement would be achieved, this forecast assumes that we would not receive
any milestone or royalty payments under the Micromet Marketing Agreement.
ROYALTIES
We currently receive
royalty revenues from existing licensing arrangements with Merck primarily related to sales of two marketed drug products, namely,
PegIntron
®
and Sylatron
®
. Until 2017, in recent years, royalty revenues from Merck were our primary
source of revenues. In 2018, we earned a $7 million milestone payment from Servier in connection with its receiving FDA approval
for ASPARLAS, also known as SC Oncaspar. In 2017, we earned $7 million in royalties from Nektar in connection with our entering
into the Nektar Second Amendment. Royalty revenues from sales of PegIntron accounted for approximately (2)% and 7% of our total
revenues in each of the years ended December 31, 2018 and 2017, respectively, net of the effects of adjustments for Merck’s
recoupment of previously overpaid royalties. Our right to receive royalties on U.S. and European sales of PegIntron expired in
2016 and 2018, respectively.
Sales of PegIntron
have been in decline since 2008. Products that compete with PegIntron have been and potentially will be introduced by other drug
manufacturers. In addition, 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, we expect sales of PegIntron-related products to continue
their declining trend.
We have out-licensed
our proprietary PEGylation and single-chain antibody, or SCA, technologies on our own and through agreements with Nektar and Micromet
AG (“Micromet”). Micromet was acquired by Amgen in 2012. Under our Cross-License and Option Agreement with Nektar,
Nektar had the lead role in granting sublicenses for certain of our PEGylation patents and we receive royalties on sales of any
approved product for which a sublicense has been granted. Pursuant to the Nektar Second Amendment, we are no longer entitled to
any royalties or immunity fees from Nektar under the Nektar License Agreement.
PATENTS AND INTELLECTUAL PROPERTY RIGHTS
We have a portfolio
of issued U.S. patents, many of which have foreign counterparts. Of the patents owned or exclusively licensed by us, one relates
to PegIntron. The patent related to PegIntron (peginterferon alfa-2b) expired in the U.S. in 2016 and expired outside of the U.S.
in 2018 (including any patent term extensions), except for Japan, where the patent was extended until 2021 and Malaysia and Chile,
where the patent expires in 2020 and 2024, respectively. Although we believe that our patents provide certain protection from competition,
we cannot assure you that such patents will be of substantial protection or commercial benefit to us, will afford us adequate protection
from competing products, or will not be challenged or declared invalid. In addition, we cannot assure you that additional U.S.
patents or foreign patent equivalents will be issued to us.
Patents for individual
products extend for varying periods according to the date of patent filing or grant and the legal term of patents in the various
countries where patent protection is obtained. Many of our patents have expired or are nearing the end of their patent protection
period. The actual protection afforded by a patent, which can vary from country to country, depends upon the type of patent, the
scope of its coverage and the availability of legal remedies in the country.
GOVERNMENT REGULATION
Although we are no
longer engaged in clinical activities, our patent assignees are subject to various government regulatory processes. The
FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements
on the clinical development, manufacture, and marketing of pharmaceutical products. These agencies and other federal, state, local
and foreign entities regulate research and development activities and the inspection, testing, manufacture, quality assurance,
safety, effectiveness, labeling, packaging, storage, distribution, record-keeping, approval, and promotion of products. Drug products
require regulatory approval before commercialization. In particular, therapeutic products for human use are subject to rigorous
preclinical and clinical testing and other requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service
Act, implemented by the FDA, as well as similar statutory and regulatory requirements of foreign countries. Obtaining these marketing
approvals and subsequently complying with ongoing statutory and regulatory requirements is costly and time consuming. Any failure
by our collaborators, licensors or licensees to obtain, or any delay in obtaining, regulatory approval or in complying with post-approval
requirements, could adversely affect our ability to receive product or royalty revenues.
The approval process
can take a number of years, if approval is obtained at all, and often requires substantial financial resources, including license
application fees. The results of preclinical studies and initial clinical trials are not necessarily predictive of the results
from large-scale clinical trials, and clinical trials may be subject to additional costs, delays or modifications due to a number
of factors, including the difficulty in obtaining enough patients, clinical investigators, drug supply, or financial support.
Any products
manufactured or distributed by our licensees pursuant to FDA approvals are subject to extensive continuing regulation by the
FDA, including record-keeping requirements and a requirement to report adverse experiences with the product. In addition to continued
compliance with standard regulatory requirements, the FDA also may require post-marketing testing and surveillance to monitor the
safety and efficacy of the marketed drug product. Product approvals may be withdrawn if compliance with regulatory requirements
is not maintained or if problems concerning safety or efficacy of the product are discovered following approval.
Even after FDA approval
has been obtained, and often as a condition to expedited approval, further studies, including post-marketing studies, are typically
required by the FDA. Results of post-marketing studies may limit or expand the further marketing of the products. If the developer
of a product proposes any modifications to the product, including changes in indication, manufacturing or testing processes, manufacturing
facility or labeling, an NDA or BLA supplement may be required to be submitted to and approved by the FDA.
We cannot predict the
extent of government regulation that might result from current or future legislation or administrative action. Any proposed or
actual changes could cause our collaborators to limit or eliminate spending on development projects and may otherwise impact us.
We cannot predict the likelihood, nature or extent of adverse governmental regulation that might result from current or future
legislative or administrative action, either in the U.S. or abroad. Additionally, in both domestic and foreign markets, sales of
our proposed products will depend, in part, upon the availability of reimbursement from third-party payors, such as government
health administration authorities, managed care providers, private health insurers and other organizations. Significant uncertainty
often exists as to the reimbursement status of newly approved health care products. In addition, third-party payors are increasingly
challenging the price and cost-effectiveness of medical products and services.
With respect to patented
products, delays imposed by the government approval process may materially reduce the period during which we will have the exclusive
right to exploit them.
EMPLOYEES AND EXECUTIVE OFFICERS
We currently have no
employees. Our executive officers provide services to us on a consulting basis.
Item 1A. Risk Factors
Throughout this Annual
Report on Form 10-K, we have made forward-looking statements in an attempt to better enable the reader to understand our future
prospects and make informed judgments. By their nature, forward-looking statements are subject to numerous factors that may influence
outcomes or even prevent their eventual realization. Such factors may be external to the Company and entirely outside of our control.
We cannot guarantee
that our assumptions and expectations will be correct. Failure of events to be achieved or of certain underlying assumptions to
prove accurate could cause actual results to vary materially from past results and those anticipated or projected. We do not intend
to update forward-looking statements.
Certain risks and uncertainties
are discussed below. However, it is not possible to predict or identify all such factors. Accordingly, you should not consider
this recitation to be complete.
Risks Relating to the Proposed Dissolution
and Liquidation
The proposed dissolution and liquidation
of the Company may not be completed in a timely manner or at all.
On February 4, 2016,
our Board of Directors adopted a Plan of Liquidation and Dissolution, pursuant to which the Company 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 the State of Delaware. In approving the Plan of Liquidation and Dissolution, our Board of Directors had considered, among
other factors, the ability of the Company to obtain no-action relief from the SEC to suspend certain of the Company’s reporting
obligations under the Securities Exchange Act of 1934, as amended, and the anticipated cost savings if such relief is granted by
the SEC. After further consideration, our Board of Directors determined that it would be fair, advisable and in the best interests
of the Company and its stockholders to postpone seeking stockholder approval of the Plan of Liquidation and Dissolution until a
later time to be determined by our Board of Directors.
From
time to time, our Board of Directors reviews the Company’s status and prospects in deciding on the timing of dissolution
and liquidation of the Company pursuant to the Plan of Liquidation and Dissolution. If our Board of Directors determines to
seek stockholder approval of such plan and such plan is approved by our stockholders and implemented by the Company, it is expected
that our corporate existence will continue for the purpose of winding up our business and affairs for at least three years.
We have forecasted minimal or no royalty or milestone revenues for the foreseeable future. In light of the uncertainty as to whether
any of the milestones under the Micromet Marketing Agreement would be achieved, this forecast assumes that we would not receive
any milestone or royalty payments under the Micromet Marketing Agreement.
The amount we distribute to our stockholders
as liquidating distributions, if any, pursuant to the Plan of Liquidation and Dissolution may be substantially less than estimated.
At present, we cannot
determine with certainty the amount of any liquidating distribution to our stockholders if the Plan of Liquidation and Dissolution
is implemented. The amount of cash ultimately distributed to our stockholders in any liquidating distribution pursuant to the Plan
of Liquidation and Dissolution depends on, among other things, the amount of our liabilities, obligations and expenses and claims
against us, and the amount of the reserves that we establish during the liquidation process. Estimates of these amounts may be
inaccurate. Factors that could impact these estimates include the following: (i) if any of the estimates regarding the Plan of
Liquidation and Dissolution, including the expenses to satisfy outstanding obligations, liabilities and claims during the liquidation
process, are inaccurate, (ii) if litigation is brought against us or our directors and officers, if unforeseen claims are asserted
against us, we will have to defend or resolve such claims or establish a reasonable reserve before making distributions to our
stockholders, (iii) if the estimates regarding the expenses to be incurred in the liquidation process, including expenses of personnel
required and other operating expenses (including legal, accounting and other professional fees) necessary to dissolve and liquidate
the Company, are inaccurate and (iv) if we continue to incur significant expenses related to ongoing reporting obligations.
Risks Relating to the Company and its
Operations
Until 2017, in recent years, we derived most of our royalty
revenues from continued sales of PegIntron, which have been in sharp decline and have been subject to recoupments for substantial
returns and rebates. In addition, our right to receive royalties on U.S. and European sales of PegIntron expired in 2016 and 2018,
respectively, which has negatively impacted our royalty revenues.
Until 2017, in recent
years, we had derived most of our royalty revenues from continued sales of PegIntron, which is marketed by Merck. Royalty
revenues from sales of PegIntron accounted for approximately (2)% and 7% of our total royalty revenues in each of the years ended
December 31, 2018 and 2017, respectively, net of the effects of adjustments for Merck’s recoupment of previously overpaid
royalties. Sales of PegIntron have been in sharp decline in recent years, and our right to receive royalties on U.S. and European
sales of PegIntron expired in 2016 and 2018, respectively, which adversely affected our operating results and financial position.
As reported by Merck, sales declines were driven by lower volumes in nearly all regions as the availability of new therapeutic
options resulted in continued loss of market share. It is unlikely that Merck will continue to generate sales of PegIntron at levels
that would enable us to receive royalties in amounts that are comparable with the amounts of royalties that we have received in
recent years. In addition, product returns and rebates may limit future royalties and allow Merck to recoup prior paid royalties.
Neither the amount nor timing of resources dedicated by Merck to the marketing of PegIntron nor Merck’s policies related
to product returns and rebates is within our control. In addition, 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, we expect that
sales of PegIntron-related products will continue their declining trend.
We may not be able to sustain profitability
and we may incur losses over the next several years.
We have incurred losses
in the past and have limited sources of revenues. Our revenues and operating results will likely fluctuate in future periods due
to variations in our recurring royalty revenues, which are expected to continue to decline. In anticipation of the revenue decline,
we have commensurately reduced our operating expenses, including the cessation of our research and development activities, elimination
of our workforce, discontinuance of our significant lease commitment and the use of consultants in order to sustain profitability.
However, with the sustained decline in revenue and the expectation of continued operating expenses, there can be no assurance that
we will be successful in maintaining profitability.
Certain of our rights to receive royalties
on sales of PegIntron and sales of other drug products have already expired and our remaining rights to receive royalties will
expire in the near future and we currently do not intend to acquire new sources of royalty revenues.
Merck’s obligation
to pay us royalties on sales of PegIntron terminates, on a country-by-country basis, upon the later of the date on which the last
patent to contain a claim covering PegIntron expires in the country or 15 years after the date on which PegIntron was first approved
for commercial marketing in such country. Our right to receive royalties on sales of PegIntron expired in the U.S. in 2016, expired
in Europe in 2018 and will expire in Malaysia in 2020, Japan in 2021 and Chile in 2024. We currently do not intend to acquire new
sources of royalty revenues. As a result, following expirations of our rights to receive royalties on sales of PegIntron and sales
of other drug products or potential drug products, we may not have sufficient revenues to continue operations.
We may not realize our deferred income
tax assets.
The ultimate realization
of our deferred income tax assets is dependent upon generating future taxable income, executing tax planning strategies, and reversals
of existing taxable temporary differences. We have recorded a full valuation allowance against our deferred income tax assets.
The valuation allowance may fluctuate as conditions change. Our ability to utilize net operating loss (“NOL”) carryforwards
to offset our future taxable income and/or to recover previously paid taxes would be limited if we were to undergo an “ownership
change” within the meaning of Section 382 of the Internal Revenue Code (the “IRC”). In general, an “ownership
change” occurs whenever the percentage of the stock of a corporation owned by “5-percent shareholders” (within
the meaning of Section 382 of the IRC) increases by more than 50 percentage points over the lowest percentage of the stock of such
corporation owned by such “5-percent shareholders” at any time over the testing period.
An ownership change
under Section 382 of the IRC would establish an annual limitation to the amount of NOL carryforwards we could utilize to offset
our taxable income in any single year. The application of these limitations might prevent full utilization of the deferred tax
assets attributable to our NOL carryforwards. There can be no assurance that we will not undergo an ownership change within the
meaning of Section 382. See Note 10 to our Financial Statements, included in Item 8 in this document.
We have outsourced all corporate functions,
which makes us more dependent on third parties to perform these corporate functions.
We have outsourced
all corporate functions, which makes us more dependent on third parties for the performance of these functions. To the extent that
we are unable to effectively reallocate employee responsibilities, retain key officers as consultants, maintain effective internal
control over financial reporting and effective disclosure controls and procedures, establish and maintain agreements with competent
third-party contractors on terms that are acceptable to us, or effectively manage the work performed by any retained third-party
contractors, our ability to manage the operations of our business effectively could be compromised.
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.
We may face liability
claims related to the use or misuse of our product candidates in previously conducted clinical trials. These claims may be expensive
to defend and may result in large judgments against us. Any such claims against us, regardless of their merit, might result in
significant costs to defend or awards against us, and our insurance coverage and resources may not be sufficient to satisfy any
liability resulting from such claims. A successful product liability or other claim brought against us could cause the market price
of our common stock to decline and, if judgments exceed our insurance coverage, could decrease our cash and materially harm our
business, financial condition or results of operations.
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,
collaboration and other agreements with biotechnology and pharmaceutical companies. These agreements contain complex commercial
terms, including royalties on drug sales based on a number of complex variables (including net sales calculations, geography, scope
of patent claim coverage, patent life and other factors) and indemnification obligations. From time to time, we may have dispute
resolution discussions with third parties regarding the appropriate interpretation of the complex commercial terms contained in
our agreements. One or more disputes may arise or escalate in the future regarding our agreements that may ultimately result in
costly litigation and unfavorable interpretation of contract terms, which 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.
Our licensees may be
unable to maintain regulatory approvals for currently licensed products or obtain regulatory approvals for new products. Safety
issues could also result in the failure to maintain regulatory approvals or decrease revenues.
Risks Relating to Our Common Stock
The price of our common stock has been,
and may continue to be, volatile.
Historically, the market
price of our common stock has fluctuated over a wide range, and it is likely that the price of our common stock will continue to
be volatile in the future. The market price of our common stock could be impacted due to a variety of factors, including, in addition
to global and industry-wide events:
|
·
|
the level of revenues we
generate from royalties we receive;
|
|
·
|
changes in our business
plans;
|
|
·
|
the losses we may incur;
|
|
·
|
developments in patent
or other proprietary rights owned or licensed by us, our collaborative partners or our competitors;
|
|
·
|
public concern as to the
safety and efficacy of products developed by others; and
|
In addition, due to
one or more of the foregoing factors in one or more future quarters, our results of operations may fall below the expectations
of securities analysts and investors. In that event, the market price of our common stock could materially decline.
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.
Our common stock is
quoted on the OTCQX market of the OTC Markets Group, Inc. and the quotation of our common stock on the OTCQX market does not assure
that a liquid trading market exists or will develop. Stocks traded on the OTCQX market generally have very limited trading volume
and exhibit a wider spread between the bid/ask quotations than stocks traded on national exchanges. Moreover, a significant number
of institutional investors have investment policies that prohibit them from trading in stocks on the OTCQX marketplace. As a result,
investors may find it difficult to dispose of, or to obtain accurate quotations of the price of, our common stock. This significantly
limits the liquidity of our common stock and may adversely affect the market price of our common stock.
We do not currently,
and are not expected in the future to, meet the listing standards of any national exchange. We presently anticipate that our common
stock will continue to be quoted on the OTCQX market. As a result, investors must bear the economic risk of holding their shares
of our common stock for an indefinite period of time. In the future, our common stock could become subject to “penny stock”
rules which impose additional disclosure requirements on broker-dealers and could further negatively impact market liquidity for
our common stock and our stockholders’ ability to sell their shares of our common stock.
The declaration of dividends is within
the discretion of our Board of Directors, subject to any applicable limitations under Delaware corporate law. Our ability to pay
dividends in the future depends on, among other things, our future royalty revenues, which are expected to decrease sharply over
the next several years, as well as our ability to manage expenses, including costs relating to our ongoing operations.
In April 2013, we 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 our stockholders. The declaration of dividends is within the discretion of our Board of Directors, subject
to any applicable limitations under Delaware corporate law, and, therefore, our Board of Directors could decide in the future not
to declare dividends. In addition, our ability to pay dividends in the future depends on, among other things, our future revenues
from existing and any future royalties and/or milestone payments and our ability to manage expenses, including costs relating to
our ongoing operations. Our future revenues from existing royalties have decreased sharply over the last several years and are
expected to continue to decrease sharply over the next several years (and eventually cease altogether) due to eventual expirations
over time of our right to receive royalties under the terms of our existing licensing arrangements. Future revenues from existing
royalties may also decline due to decreases in the sales of the drug products for which we have the right to receive royalties.
There is no assurance that we will have sufficient royalty revenues to be able to pay dividends in the future. Moreover, if we
file a Plan of Liquidation and Dissolution, the applicable Delaware court may impose limitations on our ability to declare dividends
prior to the final dissolution of the Company. Any inability to pay dividends could cause the market price of our common stock
to decline significantly.
Anti-takeover provisions in our charter
documents and under Delaware corporate law may make it more difficult to acquire us, even though such acquisitions may be beneficial
to our stockholders.
Provisions of our certificate
of incorporation and bylaws, as well as provisions of Delaware corporate law, could make it more difficult for a third party to
acquire us, even though such acquisitions may be beneficial to our stockholders. These anti-takeover provisions include:
|
·
|
lack of a provision for
cumulative voting in the election of directors;
|
|
·
|
the ability of our board
to authorize the issuance of “blank check” preferred stock to increase the number of outstanding shares and thwart
a takeover attempt;
|
|
·
|
advance notice requirements
for nominations for election to the board of directors or for proposing matters that can be acted upon by stockholders at stockholder
meetings; and
|
|
·
|
limitations on who may
call a special meeting of stockholders.
|
The provisions described
above and provisions of Delaware corporate law relating to business combinations with interested stockholders may discourage, delay
or prevent a third party from acquiring us. These provisions may also discourage, delay or prevent a third party from acquiring
a large portion of our securities, or initiating a tender offer, even if our stockholders might receive a premium for their shares
in the acquisition over the then current market price.
Our previous Section 382 rights plan expired
on April 30, 2017 and has not been replaced.
The issuance of preferred stock may
adversely affect rights of our common stockholders.
Under our certificate
of incorporation, our Board of Directors has the authority to issue up to three million shares of “blank check” preferred
stock and to determine the price, rights, preferences and privileges of those shares without any further vote or action by our
stockholders. The rights of the holders of common stock will be subject to the rights of the holders of any shares of preferred
stock that may be issued in the future. In addition to discouraging a takeover, as discussed above, this “blank check”
preferred stock may have rights, including economic rights senior to the common stock, and, as a result, the issuance of such preferred
stock could have a material adverse effect on the market value of our common stock.
Item 1B. Unresolved Staff Comments
None.
Item 2. Properties
Since March 1, 2016,
and July 1, 2018, we have occupied the following New Jersey and Vermont office spaces, respectively, pursuant to office service
agreements:
Location
|
|
Principal Use
|
|
Approx.
Square
Footage
|
|
|
Approx.
Annual Rent
|
|
|
Expiration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20 Commerce Drive (Suite 135), Cranford, New Jersey
|
|
Executive offices
|
|
|
500
|
|
|
$
|
3,000
|
|
|
|
August 31, 2019
|
|
3556 Main Street, Manchester, Vermont
|
|
Executive offices
|
|
|
500
|
|
|
$
|
8,500
|
|
|
|
June 30, 2019
|
|
We believe that the
above office spaces are generally adequate for our present and anticipated future needs.
In February 2016, we
terminated our prime lease and sublease and, effective March 1, 2016, we entered into an office service agreement for new office
space, as shown, above. See Item 1. Business.
We currently own no
real property.
Item 3. Legal Proceedings
From time to time,
we are engaged in litigation arising in the ordinary course of our business. There are currently no pending material litigation
to which we are a party or to which any of our property is subject.
Item 4. Mine Safety Disclosures
Not applicable.
PART II.
Item 5. Market for Registrant’s
Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities
Market Information
Since August 9, 2016,
our common stock has been quoted for trading on the OTCQX market of the OTC Markets Group, Inc. under the trading symbol “ENZN.”
Holders
As of February 8, 2019,
there were 849 holders of record of our common stock.
Dividends
In
April 2013, we 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 our stockholders. The declaration of dividends is within the discretion of our Board
of Directors, subject to any applicable limitations under Delaware corporate law, and therefore our Board of Directors could decide
in the future not to declare dividends. In addition, our ability to pay dividends in the future depends on, among other things,
our future revenues from existing royalties and our ability to manage expenses, including costs relating to our ongoing operations
.
Repurchase of Equity Securities
Common Stock
On December 21, 2010,
our Board of Directors had authorized a share repurchase program under which we are authorized to repurchase up to $200 million
of our outstanding common stock. Since the inception of this share repurchase program, the cumulative number of shares repurchased
and retired through December 31, 2018 amounts to 16,174,578 shares at a total cost of $153.4 million, or an average cost per share
of approximately $9.48.
Since December 2012,
we have suspended repurchases under the share repurchase program and do not currently intend to resume repurchases under the share
repurchase program. Accordingly, no shares were repurchased in 2018 and 2017.
Item
6. Selected Financial Data
As a smaller reporting
company, we are not required to provide the information required by this item.
Item 7. Management’s Discussion and Analysis
of Financial Condition and Results of Operations
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 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. 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 and not the rounded millions of dollars
reflected in this section.
Overview
In 2018, the primary source of our royalty
revenues was
related to a milestone payment of $7.0 million due from Servier.
On December 20, 2018, we were notified that the FDA approved Servier’s
BLA for
calaspargase
pegol – mknl (brand name ASPARLAS™), also known as SC Oncaspar. Pursuant to
an agreement originally entered
into with Sigma-Tau in July 2015, and ultimately assigned to Servier, we earned a milestone payment of $7 million.
Accordingly,
we recorded revenue and a receivable of $7.0 million as of December 31, 2018.
In 2017, the primary source of our
royalty revenues was the revenues from
Nektar pursuant to the
Nektar Second Amendment to the
Nektar License Agreement with
Nektar, which generated non-recurring royalty revenues of $7 million
(see below). The receipt of this $7 million satisfied
all future obligations of royalty payments to us pursuant to the Nektar
License Agreement.
Prior
to 2017, the
primary source of our royalty revenues was derived from sales of PegIntron, which is marketed by Merck.
We currently have no clinical operations and limited corporate operations.
We have
no
intention of resuming any clinical development activities or acquiring new sources of royalty revenues. Royalty revenues from
sales of PegIntron accounted for (2)% and 7% of our total revenues for the years ended December 31, 2018 and
2017, respectively, net of the effects of adjustments for Merck’s recoupment of previously overpaid royalties. The
effects of such recoupments were recorded as a decrease of royalty revenues aggregating approximately $280,000 and $877,000
for the years ending December 31, 2018 and 2017, respectively, as discussed in Note 4 to the Consolidated Financial
Statements.
In March 2018, Merck
notified us that a downward adjustment of approximately $313,000 in royalties was necessary, resulting primarily from product returns
relating to periods prior to December 31, 2017. Accordingly, at December 31, 2017, we accrued a liability to Merck of approximately
$313,000 and partially offset that amount by the $88,000 that was due to us from Merck. Thus, we recorded a net payable to Merck
of approximately $225,000 at December 31, 2017. In January 2018, Merck paid us the $88,000, which increased the liability to $313,000.
During the second quarter, we earned approximately $60,000 of royalties, which reduced the royalty payable to Merck to $253,000.
During the third quarter of 2018, Merck notified us of an additional recoupment of approximately $280,000, resulting primarily
from product rebates and returns. In the fourth quarter, we earned approximately $94,000 of royalties. Accordingly, the liability
to Merck was $439,000 at December 31, 2018, as discussed in Note 4 to the Condensed Consolidated Financial Statements.
In April 2013, we
announced that we intended to distribute excess cash, expected to arise from royalty revenues, in the form of periodic
dividends to stockholders. On February 4, 2016, our Board adopted the Plan of Liquidation and Dissolution, the implementation of which has been postponed. (See Note 14 to our Consolidated
Financial Statements.)
On
January 30, 2019, we entered into a letter agreement with Servier, in connection with the Asset Purchase Agreement, by
and between Klee Pharmaceuticals, Inc., Defiante and Sigma-Tau, on the one hand, and the Company, on the other hand. Under
the letter agreement, Servier, as successor-in-interest to Defiante, has confirmed its obligation to pay us a $7.0
million milestone payment related to SC Oncaspar as a result of the FDA’s December 20, 2018 approval of calaspargase
pegol – mknl (brand name ASPARLAS™) as a component of a multi-agent chemotherapeutic regimen for the treatment of
acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. In addition, under the
letter agreement, we agreed to waive Servier’s obligations to pursue the development of SC Oncaspar in Europe and
the approval of SC Oncaspar by the EMEA under the Asset Purchase Agreement, provided that we are not waiving Servier’s
obligation to make any applicable milestone payment to us upon EMEA approval, if any, of SC Oncaspar. Servier is required to
pay the $7.0 million milestone payment to us within three business days following the parties’ completion of procedures
for claiming benefits under the double tax treaty between the United States and the United Kingdom. We expect to receive the
$7.0 million milestone payment from Servier by the third quarter of 2019. However, no assurance can be given as to the timing
of our receipt of the payment.
On June 26, 2017, we
entered into the Nektar Second Amendment, wherein Nektar agreed to buy-out all remaining payment obligations to us under the Nektar
License Agreement. In consideration for fully paid-up licenses under the Nektar License Agreement and for the dismissal with prejudice
of all claims and counterclaims asserted in the litigation with Nektar, Nektar agreed to pay us the sum of $7.0 million, which
satisfies all future obligations of royalty payments pursuant to the Nektar License Agreement, the first $3.5 million of which
was paid within one business day of the effective date of the Nektar Second Amendment and the remaining $3.5 million was to be
paid within one business day of January 5, 2018. Accordingly, we recorded revenue of $7.0 million and a receivable of $3.5 million
in the second quarter of 2017. The remaining payment of $3.5 million was received in December 2017.
We
may be entitled to certain potential future milestone payments contingent upon the achievement of certain regulatory approval-related
milestones by third-party licensees. There can be no assurance that the Company will receive any milestone payments resulting from
its agreements with any of our third-party licensees.
We will not recognize revenue from
any
of our third-party licensees
until all revenue recognition requirements are met.
Commencing on March
1, 2016, we changed the location of its principal executive offices to 20 Commerce Drive, Suite 135, Cranford, New Jersey, 07016.
We entered into an office service agreement with Regus for use of office space at this
location effective March 1, 2016. Under the agreement, in exchange for our right to use the office space at this location, we were
required to pay Regus an initial service retainer of $2,418 and thereafter pay Regus a monthly fee of $1,209 until February 28,
2017. This agreement was renewed for two one-year extensions, until February 28, 2019, for a monthly fee of $1,259. In June 2018,
we and Regus agreed to end the lease on August 31, 2018, and replace it with an updated office service agreement. We entered into
an office service agreement with Regus for mailbox, plus telephone answering and virtual office services effective September 1,
2018. Under the agreement, in exchange for the services provided by Regus, we were required to pay Regus a monthly fee of $259
until August 31, 2019.
Effective July 1, 2018,
we entered into an office rental agreement with Equinox for use of office space at 3556 Main
Street, Manchester, VT, 05225. Under this agreement, in exchange for our right to use the office space at this location, we are
required to pay Equinox a monthly fee of $708 until June 30, 2019.
Plan of Dissolution
On February 4, 2016,
our Board of Directors adopted a Plan of Liquidation and Dissolution, pursuant
to which the Company 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 the State of Delaware. In approving the Plan of Liquidation and Dissolution,
our Board of Directors had considered, among other factors, the ability of the Company to obtain no-action relief from the Securities
and Exchange Commission (the “SEC”) to suspend certain of the Company’s reporting obligations under the Securities
Exchange Act of 1934, as amended, and the anticipated cost savings if such relief is granted by the SEC. Upon further review, our
Board of Directors determined that it would be fair, advisable and in the best interests of the Company and its stockholders to
postpone seeking stockholder approval of the Plan of Liquidation and Dissolution until a later time to be determined by our Board
of Directors.
From
time to time, our Board of Directors reviews the Company’s status and prospects in deciding on the timing of dissolution
and liquidation of the Company pursuant to the Plan of Liquidation and Dissolution. If our Board of Directors determines to
seek stockholder approval of such plan and such plan is approved by our stockholders and implemented by the Company, it is expected
that our corporate existence will continue for the purpose of winding up our business and affairs for at least three years.
We have forecasted minimal or no royalty or milestone revenues for the foreseeable future. In light of the uncertainty as to whether
any of the milestones under the Micromet Marketing Agreement would be achieved, this forecast assumes that we would not receive
any milestone or royalty payments under the Micromet Marketing Agreement.
Results of Operations
(in millions
of dollars):
|
|
For the Year Ended December 31,
|
|
|
|
2018
|
|
|
2017
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Royalties and milestones, net
|
|
$
|
6.9
|
|
|
$
|
8.4
|
|
Total revenues
|
|
|
6.9
|
|
|
|
8.4
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
1.1
|
|
|
|
1.4
|
|
Operating income
|
|
|
5.8
|
|
|
|
7.0
|
|
Income tax expense
|
|
|
-
|
|
|
|
(1.6
|
)
|
Net income
|
|
$
|
5.8
|
|
|
$
|
5.4
|
|
Overview
The following
table summarizes our royalties earned in 2018 and 2017:
Royalties and Milestones Revenues
(in millions of dollars):
|
|
For the Year Ended December 31,
|
|
|
|
|
|
|
%
|
|
|
|
|
|
|
2018
|
|
|
Change
|
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
|
Royalties and milestones revenues
|
|
|
7.2
|
|
|
|
(23
|
)
|
|
|
9.3
|
|
Less: Adjustment by Merck for returns and rebates
|
|
|
(0.3
|
)
|
|
|
(67
|
)
|
|
|
(0.9
|
)
|
|
|
$
|
6.9
|
|
|
|
(18
|
)
|
|
$
|
8.4
|
|
Until 2017, in recent
years, our royalty revenues had been derived, primarily, from sales of PegIntron. In 2018 and 2017, we earned total royalties
and milestones revenues of approximately $6.9 million and $8.4 million, respectively. The revenues in 2018 resulted from $7.0 million
earned pursuant to a milestone reached by Servier. The revenues in 2017 were substantially attributable to the $7.0 million we
received in connection with the Nektar Second Amendment. Royalty revenues from sales of PegIntron accounted for approximately (2)%
and 7% of our total royalty revenues in 2018 and 2017, respectively. Our right to receive royalties on U.S. and European sales
of PegIntron expired in 2016 and 2018, respectively.
In the second
quarter of 2017, Merck notified us that they discovered additional overpayments to us resulting from their inaccuracy as to the
date on which our right to receive royalties from various countries’ sales of PegIntron expired. Such net overpayment to
us aggregated approximately $564,000 in royalties during 2015 and 2016. Merck notified us that it intended to recover such overpayment
from us by reducing future royalties to which we would otherwise be entitled from Merck until the full amount of the overpayment
had been recouped. In the third quarter of 2017, Merck again notified us that, based on rebates and returns of PegIntron products,
they had deducted a net amount of approximately $150,000 from aggregate royalties that were otherwise due to us. We took exception
to certain of the deductions taken by Merck as being inappropriate. In the fourth quarter of 2017, Merck corrected such deductions
and added a net $111,000, to the royalties that were otherwise due to the Company. The aggregate amount of royalties earned from
Merck during 2017 was approximately $1.3 million. In March 2018, Merck notified us that an additional adjustment of approximately
$313,000 was necessary, primarily, due to returns from sales in China in the fourth quarter of 2017. Merck will recoup this through
deductions from future royalties otherwise payable to us. Accordingly, we recorded an aggregate reduction for overpayments, rebates
and returns of approximately $1.6 million from the gross royalties earned during 2016 and 2017, leaving a balance due to Merck
of approximately $225,000. This was recorded as a payable at December 31, 2017.
In January 2018, Merck
paid the $88,000 to the Company, which increased the liability to $313,000. During the second quarter, Enzon earned approximately
$60,000 of royalties, which reduced the royalty payable to Merck to $253,000. During the third quarter of 2018, Merck notified
the Company of an additional recoupment of approximately $280,000, resulting primarily from product rebates and returns. In the
fourth quarter, Enzon earned approximately $94,000 of royalties. Accordingly, the liability to Merck was $439,000 at December 31,
2018, as discussed in Note 4 to the Condensed Consolidated Financial Statements.
Royalty revenues decreased
approximately 100% in 2018 compared to 2017. This was primarily due to a 99% decrease in royalties on PegIntron, including recoupments
of previously overpaid royalties, aggregating approximately $280,000 in 2018. As reported by Merck, in recent years, sales declines
were driven by lower volumes in nearly all regions, as the availability of new therapeutic options resulted in continued loss of
market share.
Any future revenues
are heavily weighted towards royalties and revenues to be received from the use of our technology and are dependent upon numerous
factors outside of our control. Until 2017, we derived most of our royalty revenues from sales of PegIntron, which have
been in decline since 2008. Merck’s obligation to pay us royalties on sales of PegIntron terminates, on a country-by-country
basis, upon the later of the date on which the last patent to contain a claim covering PegIntron expires in the country or 15 years
after the date on which PegIntron was first approved for commercial marketing in such country. Our rights to receive royalties
from sales of PegIntron expired in the U.S. in 2016, expired in Europe in 2018 and will expire in Malaysia in 2020, Japan in 2021
and Chile in 2024.
Other factors potentially
affecting our royalty revenues include new or increased competition from products that may compete with the products for which
we receive royalties and the effectiveness of marketing by our licensees. Our rights to receive royalties and immunity fees on
OMONTYS, CIMZIA and Macugen terminated as a result of us entering into the Nektar Second Amendment in 2017.
In addition, 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, we expect that sales of PegIntron-related products will continue their declining trend.
General and Administrative Expenses
(in millions of dollars):
|
|
For the Year Ended December 31,
|
|
|
|
|
|
|
%
|
|
|
|
|
|
|
|
2018
|
|
|
|
Change
|
|
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses
|
|
$
|
1.1
|
|
|
|
(21
|
)
|
|
$
|
1.4
|
|
For the year ended
December 31, 2018, general and administrative expenses were $1.1 million, down 21% from $1.4 million in the prior year. The change
in 2018 from 2017 was primarily from filing fees and general insurance expense in connection with our lease termination, as well
as a decrease in professional fees, primarily legal, incurred in 2017 in connection with the Nektar Second Amendment.
In 2018 and 2017,
general and administrative expenses consist primarily of consulting fees for executive services, outside professional services
for accounting, audit, tax, legal, financing activities and patent filing fees.
Income Taxes
On December 22, 2017,
the President of the United States signed and enacted comprehensive tax legislation into law, H.R. 1, commonly referred to as the
Tax Cuts and Jobs Act (the “Tax Act”). Except for certain provisions, the Tax Act is effective for tax years beginning
on or after January 1, 2018. The items having the most significant impact resulting from the Tax Act on our financial statements,
include: the lowering of the U.S. federal corporate income tax rate, the repeal of the corporate alternative minimum tax, the treatment
of alternative minimum tax credits as refundable tax credits and the remeasurement of certain deferred tax assets and related valuation
allowances. We completed the accounting for the tax impact of the Act as of December 31, 2017 and recorded no provisional amounts.
As a result
of royalty and milestone income for the year ended December 31, 2018, we generated $5.8 million in taxable income before utilization
of net operating loss carryforwards. We utilized net operating loss carryforwards of $5.8 million to fully offset current
year taxable income. Due to the valuation allowance placed on our 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 we recorded no deferred tax expense during the year ended December 31, 2018. We are
projecting future tax losses and have recorded a full valuation allowance against our remaining deferred tax assets as of
December 31, 2018, as we believe it is more likely than not that these assets will not be realized.
These projections and
beliefs are based upon a variety of estimates and numerous assumptions made by our management with respect to, among other things,
forecasted sales of the drug products for which we have the right to receive royalties and other matters, many of which are difficult
to predict, are subject to significant uncertainties and are beyond our control. As a result, there can be no assurance that the
estimates and assumptions upon which these projections and beliefs are based will prove accurate, that the projected results will
be realized or that the actual results will not be substantially higher or lower than projected.
Liquidity and Capital Resources
Our current sources
of liquidity are (i) our existing cash on hand and (ii) anticipated milestone payments from third-party licensee. 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 and anticipated milestone payments will
be sufficient to fund our operations, at least, through February 29, 2020. However, our future royalty revenues are expected to
be minimal over the next several years.
Cash provided by operating
activities represents net income, as adjusted for certain non-cash items including the effect of changes in operating assets and
liabilities. Cash used in operating activities during 2018 was $1.0 million, as compared to cash provided by operating activities
of $6.5 million in 2017. The decrease was due, primarily to the $.4 million increase in net income, as adjusted by the $7 million
increase in milestone receivables (due from Servier), and partially offset by an increase in accounts payable of approximately
$0.2 million (recoupment by Merck).
Cash used in financing
activities was none in 2018 and $6.6 million in 2017. In 2017, this was entirely attributable to the payments of approximately
$6.6 million in dividends on our common stock in September 2017.
The net effect of the
foregoing was a decrease of cash of approximately $1.0 million, from $7.5 million at December 31, 2017 to $6.5 million at December
31, 2018.
Off-Balance Sheet Arrangements
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, which would have been established for the purpose of facilitating off-balance
sheet arrangements or other contractually narrow limited purposes. As of December 31, 2018, we were not involved in any off-balance
sheet special purpose entity transactions.
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. (“U.S. GAAP”).
All applicable U.S. GAAP accounting standards effective as of December 31, 2018 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.
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 income when
the milestone has been achieved and collection is assured. Such payments are non-refundable and no further effort is required on
our part 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 of December 31, 2018, 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. 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.
Stock-Based Compensation
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 stock-based compensation 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 the date of grant or
modification. Fair value of stock-based compensation is determined using the Black-Scholes valuation model, which employs weighted-average
assumptions for the expected volatility of our stock, the 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.
Item 7A. Quantitative and Qualitative
Disclosures About Market Risk
As a smaller reporting
company, we are not required to provide the information required by this item.
Item 8. Financial Statements and Supplementary
Data
Financial statements
and notes thereto appear on pages F-1 to F-25 of this Annual Report on Form 10-K.
Item 9. Changes in and Disagreements
with Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures
|
(a)
|
Evaluation of Disclosure
Controls and Procedures
|
Our management, under
the direction of our Principal Executive Officer and Principal Financial Officer, has evaluated the effectiveness of our disclosure
controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), as of December 31, 2018. Disclosure controls and procedures are designed to ensure that information
required to be disclosed in reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within
the time periods specified in SEC rules and forms and that such information is accumulated and communicated to management, including
the Principal Executive Officer and Principal Financial Officer, to allow timely decisions regarding required disclosures. Based
on that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and
procedures were effective as of December 31, 2018.
|
(b)
|
Changes in Internal
Control Over Financial Reporting
|
There were no changes
in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act,
during the quarter ended December 31, 2018 that have materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.
|
(c)
|
Management’s Report
on Internal Control over Financial Reporting
|
It is the responsibility
of the management of Enzon Pharmaceuticals, Inc. and Subsidiaries to establish and maintain effective internal control over financial
reporting (as defined in Rule 13a-15(f) under the Exchange Act). Internal control over financial reporting is a process designed
by, or under the supervision of our Principal Executive Officer and Principal Financial Officer to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles, and includes those policies and procedures that (i) pertain to the maintenance of
records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of Enzon; (ii)
provide reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements
in accordance with generally accepted accounting principles, and that receipts and expenditures of Enzon are being made only in
accordance with authorizations of management and directors of Enzon; and (iii) provide reasonable assurance regarding the prevention
or timely detection of unauthorized acquisition, use or disposition of Enzon’s assets that could have a material effect on
the consolidated financial statements of Enzon.
Under the supervision
and with the participation of our management, we conducted an evaluation of the effectiveness of our internal control over financial
reporting based on criteria established in “Internal Control—Integrated Framework - 2013” issued by the Committee
of Sponsoring Organizations of the Treadway Commission (COSO). Our management concluded that as of December 31, 2018 our internal
control over financial reporting was effective based on those criteria.
|
(d)
|
Limitations on the Effectiveness
of Controls
|
Because of its inherent
limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined
to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
/s/ Andrew Rackear
|
|
/s/ Richard L. Feinstein
|
Andrew Rackear
|
|
Richard L. Feinstein
|
Chief Executive Officer and Secretary
|
|
Vice President-Finance and Chief Financial Officer
|
(Principal Executive Officer)
|
|
(Principal Financial Officer)
|
|
|
|
February 21, 2019
|
|
February 21, 2019
|
Item 9B. Other Information
None.
The accompanying notes are an integral part
of these consolidated financial statements.
The accompanying notes are an integral part
of these consolidated financial statements.
The accompanying notes are an integral part
of these consolidated financial statements.
The accompanying notes are an integral part
of these consolidated financial statements.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
|
(1)
|
Description of Business
|
Enzon
Pharmaceuticals, Inc. (together with its subsidiaries, the “Company,” “Enzon,” “we” or
“us”), manages its sources of royalty revenues from existing licensing arrangements with other companies
primarily related to sales of certain drug products that utilize our proprietary technology. In 2018, the primary source of
the Company’s royalties and milestones revenues was
a milestone
payment of $7.0 million due from
Servier IP UK Limited
(“Servier”).
On December 20, 2018, the Company was notified that the U.S. Food and Drug Administration (the “FDA”) approved
Servier’s
Biologics License Application (“BLA”) for
calaspargase
pegol – mknl (brand name ASPARLAS™), also known as SC Oncaspar. Pursuant to
an agreement originally
entered into with Sigma-Tau Finanziaria S.p.A. (“Sigma-Tau”) in November 2009, and ultimately assigned to
Servier, the Company earned a milestone payment of $7.0 million.
Accordingly, the
Company recorded revenue and a milestone receivable of $7.0 million at December 31, 2018.
In 2017, the primary
source of the Company’s
milestone
revenues was the
revenues received from
Nektar Therapeutics, Inc. (“Nektar”) pursuant to the
Second
Amendment (“Nektar Second Amendment”) to the Company’s Cross-License and Option Agreement (the
“Nektar License Agreement”),
which generated non-recurring
milestone
revenues
of $7 million (see below). The receipt of this $7.0 million satisfied
all future obligations of royalty payments to
us pursuant to the Nektar License Agreement.
Prior
to 2017, the
primary source of our royalty revenues was derived from sales of PegIntron, which is marketed by Merck &
Co., Inc. (“Merck”). The Company currently has no clinical operations and limited corporate operations.
The
Company
has no intention of resuming any clinical development activities or acquiring new sources of royalty revenues. Royalty
revenues from sales of PegIntron accounted for (2)% and 7% of the Company’s total revenues for the years ended December 31,
2018 and 2017, respectively, net of the effects of Merck’s recoupment of previously overpaid royalties. The effects of such
recoupments were recorded as a decrease of revenues aggregating approximately $280,000 and $877,000 for the years ended December
31, 2018 and 2017, respectively, as discussed in Note 4 to the Consolidated Financial Statements.
In March 2018, Merck
notified the Company that a downward adjustment of approximately $313,000 in royalties was necessary, resulting primarily from
product returns relating to periods prior to December 31, 2017. Accordingly, at December 31, 2017, the Company accrued a liability
to Merck of approximately $313,000 and partially offset that amount by the $88,000 that was due to the Company from Merck. Thus,
the Company recorded a net payable to Merck of approximately $225,000 at December 31, 2017. In January 2018, Merck paid the $88,000
to the Company, which increased the liability to $313,000. During the second quarter of 2018, Enzon earned approximately $60,000
of royalties, which reduced the royalty payable to Merck to $253,000. During the third quarter of 2018, Merck notified the Company
of an additional recoupment of approximately $280,000, resulting primarily from product rebates and returns. In the fourth quarter,
Enzon earned approximately $94,000 of royalties. Accordingly, the liability to Merck was $439,000 at December 31, 2018, as discussed
in Note 4 to the Consolidated Financial Statements.
In April 2013,
we announced that we intended to distribute excess cash, expected to arise from royalty and milestone revenues, in the form
of periodic dividends to stockholders. On February 4, 2016, our Board adopted a Plan of Liquidation and Dissolution (the
“Plan of Liquidation and Dissolution”), the implementation of which has been postponed. (See Note 14.)
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(CONTINUED)
On
January 30, 2019, the Company entered into a letter agreement with Servier, a wholly owned indirect subsidiary of Les Laboratoires
Servier, in connection with the asset purchase agreement, dated as of November 9, 2009 (the “Asset Purchase Agreement”),
by and between Klee Pharmaceuticals, Inc., Defiante Farmacêutica, S.A. (“Defiante”) and Sigma-Tau, on the one
hand, and the Company, on the other hand. Under the letter agreement, Servier, as successor-in-interest to Defiante, has confirmed
its obligation to pay the Company a $7.0 million milestone payment related to SC Oncaspar as a result of the FDA’s December
20, 2018 approval of calaspargase pegol – mknl (brand name ASPARLAS™) as a component of a multi-agent chemotherapeutic
regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. In addition,
under the letter agreement, the Company has agreed to waive Servier’s obligations to pursue the development of SC Oncaspar
in Europe and the approval of SC Oncaspar by the European Medicines Agency (“EMEA”) under the Asset Purchase Agreement,
provided that the Company is not waiving Servier’s obligation to make any applicable milestone payment to the Company upon
EMEA approval, if any, of SC Oncaspar. Servier is required to pay the $7.0 million milestone payment to the Company within three
business days following the parties’ completion of procedures for claiming benefits under the double tax treaty between the
United States and the United Kingdom. The Company expects to receive the $7.0 million milestone payment from Servier by the third
quarter of 2019. However, no assurance can be given as to the timing of the Company’s receipt of the payment.
On June 26, 2017, the
Company entered into the Nektar Second Amendment, wherein Nektar agreed to buy-out all remaining payment obligations to the Company
under the Nektar License Agreement. In consideration for fully paid-up licenses under the Nektar License Agreement and for the
dismissal with prejudice of all claims and counterclaims asserted in the litigation with Nektar, Nektar agreed to pay the Company
the sum of $7 million, which satisfies all future obligations of royalty payments pursuant to the Nektar License Agreement. The
amount was paid in full during 2017. Accordingly, the Company recorded revenue of $7 million in 2017.
The
Company has a marketing agreement with Micromet AG (“Micromet”), now part of Amgen, Inc. (the “Micromet
Marketing Agreement”), that was entered into in 2004 under which Micromet is the exclusive marketer of the
parties’ combined intellectual property portfolio in the field of single-chain antibody technology. Under the
Micromet Marketing Agreement, the parties agreed to share, on an equal basis, in any licensing fees, milestone payments and
royalties revenue received by Micromet in connection with any licenses of the patents within the portfolio by Micromet to any
third party during the term of the collaboration. To the Company’s knowledge, Micromet has a license agreement with
Viventia Biotech (Barbados) Inc. (“Viventia”), now part of Sesen Bio, Inc. (“Sesen”), that was
entered into in 2005, under which Micromet granted Viventia nonexclusive rights, with certain sublicense rights, for know-how
and patents allowing exploitation of certain single chain antibody products, which patents cover some key aspects of
Vicinium, one of Sesen’s drug candidates that is in Phase 3 clinical trials being evaluated for the treatment of
patients with non-muscle invasive bladder cancer. To the Company’s knowledge, under the terms of this license agreement
between Micromet and Viventia, Micromet is entitled to receive (i) certain milestone payments with respect to the filing of a
new drug application for Vicinium with the FDA or the filing of a marketing approval application for Vicinium with the EMEA;
(ii) certain milestone payments with respect to the first commercial sale of Vicinium in the U.S. or Europe and (iii) certain
royalties on net sales for ten years from the first commercial sale of Vicinium. Pursuant to the Micromet
Marketing Agreement, the Company would be entitled to a 50% share of these milestone payments and royalties received by
Micromet. Due to the challenges associated with developing and obtaining approval for drug products, there is substantial
uncertainty whether any of these milestones will be achieved. The Company also has no control over the time, resources and
effort that Sesen may devote to its programs and limited access to information regarding or resulting from such programs.
Accordingly, there can be no assurance that the Company will receive any of the milestone or royalty payments under the
Micromet Marketing 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 through a lease agreement for space
and services with Regus Management Group, LLC (“Regus”) and also has an office facility at 3556 Main Street, Manchester,
VT, 05225 pursuant to an office rental agreement with Equinox Junior, LLC (“Equinox”). See Note 13.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(CONTINUED)
|
(2)
|
Summary of Significant
Accounting Policies
|
Principles of Consolidation
The consolidated financial
statements include the accounts of Enzon
Pharmaceuticals, Inc. 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.
Financial Instruments and Fair Value
The carrying values
of cash, milestone receivable, other current assets, accounts payable, accrued expenses and other current liabilities in the Company’s
consolidated balance sheets approximated their fair values at December 31, 2018 and 2017 due to their short-term nature. As of
December 31, 2018, the Company held no cash equivalents or marketable securities.
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 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.
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.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(CONTINUED)
Stock-Based Compensation Plans
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.
|
(3)
|
Recent Accounting Pronouncements
|
In May 2014, the
Financial Accounting Standards Board (“FASB”)
issued
Accounting Standards Update (“ASU”) No. 2014-09 (Topic 606), “Revenue from Contracts with Customers,”
relating to revenue recognition. This new standard provides for a single five-step model to be applied to all revenue
contracts with customers as well as requires additional financial statement disclosures that will enable users to understand
the nature, amount, timing and uncertainty of revenue and cash flows relating to customer contracts. Companies have an
option to use either a retrospective approach or cumulative effect adjustment approach to implement the standard. This
ASU, as amended, was effective January 1, 2018.
The
adoption of this update did not have a material impact on the Company’s consolidated financial statements.
In February 2016, the
FASB issued
ASU No. 2016-02
(Topic 842), “Leases,” which is intended to improve financial reporting around leasing transactions. This ASU
affects all companies and other organizations that engage in leasing transactions (both lessee and lessor) that lease assets such
as real estate and manufacturing equipment. This ASU will require organizations that lease assets – referred to as “leases”
– to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. ASU
2016-02 is effective for fiscal years and interim periods within those years beginning January 1, 2019. On January 5, 2018, the
FASB issued an exposure draft amending certain aspects of the new leasing standard. The proposed amendments include a provision
to allow entities to elect not to restate comparable periods in the period of adoption when transitioning to the new standard and
instead permit a modified retrospective approach. The Company believes that, inasmuch as its lease commitments are not material,
the new standard will not have a material effect on its
consolidated financial statements.
In August 2018, the
SEC issued the final rule on Disclosures About Changes in Stockholders’ Equity For filings on Form 10-Q, which extends to
interim periods the annual requirement in SEC Regulation S-X, Rule 3-04,2 to disclose (1) changes in stockholders’ equity
and (2) the amount of dividends per share for each class of shares (as opposed to common stock only, as previously required). Pursuant
to the final rule, registrants must now analyze changes in stockholders’ equity, in the form of a reconciliation, for “the
current and comparative year-to-date [interim] periods, with subtotals for each interim period,” i.e., a reconciliation covering
each period for which an income statement is presented. Rule 3-04 permits the disclosure of changes in stockholders’ equity
(including dividend-per-share amounts) to be made either in a separate financial statement or in the notes to the financial statements.
Th
e
final rule is effective for all filings made on or after November 5, 2018. The staff of the SEC has indicated it would not object
if the filer’s first presentation of the changes in shareholders’ equity is included in its Form 10-Q for the quarter
that begins after the effective date of the amendments. Therefore, the Company expects to conform to this rule in its Form
10-Q for the quarter ending Marc
h 31, 2019. Inasmuch as the Company has paid no dividends nor had
any stock-related transactions during the nine months ended September 30, 2018 and its only change in stockholders’ equity
during that period was its net income (loss), the Company believes that the final rule will not have a material effect on its consolidated
financial statements and disclosures.
Other recent ASU's
issued by the FASB and guidance issued by the Securities and Exchange Commission did not, or are not believed by management to,
have a material effect on the Company’s present or future consolidated financial statements.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(CONTINUED)
|
(4)
|
Accounts Payable and
Accrued Expenses
|
In March 2017,
Merck notified the Company that it had overpaid it approximately $770,000 in royalties (net of a 25% royalty interest that the
Company had previously sold) during the second and third quarters of 2016. This was due to a previous misunderstanding regarding
the date on which the Company’s right to receive royalties from U. S. sales of PegIntron expired, which Merck advised had
occurred in February 2016. Merck notified the Company that it intended to recover such overpayment from the Company by reducing
future royalties to which the Company would otherwise be entitled from Merck until the full amount of the overpayment has been
recouped. Accordingly, at December 31, 2016, the Company recorded a liability to Merck of approximately $770,000.
In the second quarter
of 2017, Merck notified the Company that they discovered additional overpayments to the Company resulting from their inaccuracy
as to the date on which the Company’s right to receive royalties from various countries’ sales of PegIntron expired.
Such net overpayment to the Company aggregated approximately $564,000 in royalties during 2015 and 2016. Merck notified the Company
that it intended to recover such overpayment from the Company by reducing future royalties to which the Company would otherwise
be entitled from Merck until the full amount of the overpayment had been recouped. In the third quarter of 2017, Merck again notified
the Company that, based on rebates and returns of PegIntron products, they had deducted a net amount of approximately $150,000
from aggregate royalties that were otherwise due to Enzon. The Company took exception to certain of the deductions taken by Merck
as being inappropriate. In the fourth quarter of 2017, Merck corrected such deductions and added a net $111,000, to the royalties
that were otherwise due to the Company. The aggregate amount of royalties earned from Merck during 2017 was approximately $1.3
million. In March 2018, Merck notified the Company that an additional adjustment of approximately $313,000 was necessary, primarily,
due to returns from sales in China in the fourth quarter of 2017. Merck will recoup this through deductions from future royalties
otherwise payable to the Company. Accordingly, the Company recorded an aggregate reduction for overpayments, rebates and returns
of approximately $1.6 million from the gross royalties earned during 2016 and 2017, leaving a balance due to Merck of approximately
$225,000. This was recorded as a payable at December 31, 2017.
In January 2018, Merck
paid the $88,000 to the Company, which increased the liability to $313,000. During the second quarter of 2018, Enzon earned approximately
$60,000 of royalties, which reduced the royalty payable to Merck to $253,000. During the third quarter of 2018, Merck notified
the Company of an additional recoupment of approximately $280,000, resulting primarily from product rebates and returns. In the
fourth quarter of 2018, Enzon earned approximately $94,000 of royalties. Accordingly, the liability to Merck was $439,000 at December
31, 2018.
Accrued expenses and
other current liabilities consist of the following as of December 31, 2018 and 2017 (in thousands):
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2018
|
|
|
2017
|
|
Professional and consulting fees
|
|
$
|
78
|
|
|
$
|
142
|
|
Other
|
|
|
-
|
|
|
|
1
|
|
|
|
$
|
78
|
|
|
$
|
143
|
|
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(CONTINUED)
Preferred Stock
The Company has authorized
3,000,000 shares of preferred stock in one or more series of which 100,000 are designated as Series A in connection with the Section
382 Rights Plan discussed below.
Common Stock
As of December 31,
2018, the Company reserved 9,818,392 shares of its common stock for the non-qualified and incentive stock plans.
Section 382 Rights Agreement
On April 30, 2014,
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 May 14, 2014.
Such rights lapsed, unexercised, at the stated expiration date of April 30, 2017 and have not been replaced.
On
August 10, 2017, the Company’s Board of Directors declared a special cash dividend of $0.15 per share of the Company’s
common stock.
This special cash dividend, aggregating approximately $6.6 million, was paid on September 26, 2017 to stockholders
of record as of August 30, 2017. See Notes 8 and 15.
|
(7)
|
Earnings Per Common
Share
|
Basic earnings per
common share is computed by dividing the net income 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 includes both the weighted-average number of shares of common stock outstanding
and the number of common stock equivalents if the inclusion of such common stock equivalents is dilutive. Dilutive common stock
equivalents potentially include stock options and nonvested shares using the treasury stock method and shares issuable under the
employee stock purchase plan (ESPP). During 2018 and 2017, there were no common stock equivalents. Earnings per common share information
is as follows (in thousands, except per share amounts) for the years ended December 31, 2018 and 2017:
|
|
2018
|
|
|
2017
|
|
Earnings per Common Share – Basic and Diluted
|
|
|
|
|
|
|
|
|
Net income for year
|
|
$
|
5,849
|
|
|
$
|
5,445
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares outstanding
|
|
|
44,215
|
|
|
|
44,215
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted earnings per share
|
|
$
|
0.13
|
|
|
$
|
0.12
|
|
At December 31, 2018
and 2017, options for 41,787 shares 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.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(CONTINUED)
Through the Compensation
Committee of the Company’s Board of Directors, the Company administers the 2011 Stock Option and Incentive Plan, which provides
incentive and non-qualified stock option benefits for employees, officers, directors and independent contractors providing services
to Enzon. Options granted to employees generally vest over four years from date of grant and options granted
to directors vest after one year. The exercise price of the options granted must be at least 100 percent of the fair value of the
Company’s common stock at the time the options are granted. Options may be exercised for a period of up to ten years from
the grant date. As of December 31, 2018, the 2011 plan authorized equity-based awards for 5 million common shares of which about
4.6 million shares remain available for grant, however, there will be no further grants made pursuant to those plans.
In connection with
the special cash dividend that was paid on September 26, 2017 to stockholders of record as of August 30, 2017 (see Note 6), the
Compensation Committee of the Board approved equitable adjustments to the Company’s outstanding stock options and restricted
stock units.
The following
is a summary of the activity in the Company’s outstanding Stock Option Plans, which include the 2011 Stock Option and Incentive
Plan, the 2001 Incentive Stock Plan, and the 1987 Non-Qualified Stock Option Plan (options in thousands):
|
|
|
|
|
Weighted
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
Exercise
|
|
|
Remaining
|
|
|
Aggregate
|
|
|
|
|
|
|
Price Per
|
|
|
Contractual
|
|
|
Intrinsic
|
|
|
|
Options
|
|
|
Option
|
|
|
Term (years)
|
|
|
Value ($000)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2018 and 2017
|
|
|
42
|
|
|
$
|
3.11
|
|
|
|
2.23
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest at December 31, 2018 and 2017
|
|
|
42
|
|
|
$
|
3.11
|
|
|
|
2.23
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2018 and 2017
|
|
|
42
|
|
|
$
|
3.11
|
|
|
|
2.23
|
|
|
$
|
-
|
|
As of December 31,
2018, there was no unrecognized compensation cost related to unvested options that the Company expects to recognize.
No options were granted
during the years ended December 31, 2018 and 2017.
In the years ended
December 31, 2018 and 2017, the Company recorded no stock-based compensation related to stock options. The Company’s policy
is to use newly issued shares to satisfy the exercise of stock options.
The Company received
no cash from exercises of stock options in either of the years ended December 31, 2018 and 2017.
|
(9)
|
Restricted Stock Awards
and Restricted Stock Units (Nonvested Shares)
|
The 2011 Stock Option
and Incentive Plan and, prior to that, the 2001 Incentive Stock Plan provide for the issuance of restricted stock awards and restricted
stock units (collectively, nonvested shares) to employees, officers and directors. However, there will be no further grants made
pursuant to those plans and, as of December 31, 2018, there were no nonvested shares outstanding.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(CONTINUED)
The components of the
income tax provision are summarized as follows (in thousands):
|
|
Year Ended December 31,
|
|
|
|
2018
|
|
|
2017
|
|
Current:
|
|
|
|
|
|
|
|
|
Federal
|
|
$
|
-
|
|
|
$
|
(1,801
|
)
|
State and foreign
|
|
|
6
|
|
|
|
2
|
|
Total current
|
|
|
6
|
|
|
|
(1,799
|
)
|
Deferred:
|
|
|
|
|
|
|
|
|
Federal and state
|
|
|
-
|
|
|
|
3,362
|
|
|
|
|
|
|
|
|
|
|
Income tax provision
|
|
$
|
6
|
|
|
$
|
1,563
|
|
The following table
represents the reconciliation between the reported income taxes and the income taxes that would be computed by applying the federal
statutory rate (21% for year ended December 31, 2018 and 35% for year ended December 31, 2017) to income before taxes (in thousands):
|
|
Year Ended December 31,
|
|
|
|
2018
|
|
|
2017
|
|
Income tax provision at federal statutory rate
|
|
$
|
1,229
|
|
|
$
|
2,453
|
|
Add (deduct) effect of:
|
|
|
|
|
|
|
|
|
State income taxes, net of federal tax
|
|
|
505
|
|
|
|
970
|
|
Refundable AMT credit
|
|
|
-
|
|
|
|
(1,801
|
)
|
Effect of tax rate change as a result of 2017 Tax Cuts and Jobs Act
|
|
|
-
|
|
|
|
16,869
|
|
Expiration of federal research and development credits
|
|
|
356
|
|
|
|
-
|
|
Expiration of capital loss carryforwards
|
|
|
248
|
|
|
|
-
|
|
Change in valuation allowance
|
|
|
(2,332
|
)
|
|
|
(14,549
|
)
|
Recognition of windfall NOLs
|
|
|
-
|
|
|
|
(2,379
|
)
|
|
|
|
|
|
|
|
|
|
Income tax provision
|
|
$
|
6
|
|
|
$
|
1,563
|
|
No federal income tax
expense was incurred in relation to normal operating results due to the utilization of deferred tax assets and related changes
in valuation allowance.
As of December 31,
2018 and 2017, the cumulative tax effects of temporary differences that give rise to the deferred tax assets are as follows (in
thousands):
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2018
|
|
|
2017
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Federal and state net operating loss carryforward
|
|
$
|
22,755
|
|
|
$
|
24,399
|
|
Research and development credits carryforward
|
|
|
16,252
|
|
|
|
16,608
|
|
Capital loss carryforwards
|
|
|
-
|
|
|
|
332
|
|
Total gross deferred tax assets
|
|
|
39,007
|
|
|
|
41,339
|
|
Less valuation allowance
|
|
|
(39,007
|
)
|
|
|
(41,339
|
)
|
Net deferred tax assets
|
|
$
|
-
|
|
|
$
|
-
|
|
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(CONTINUED)
On December 22, 2017,
the Tax Cuts and Jobs Act (the “Act”) was signed into law. Among its numerous changes to the Internal Revenue Code,
the Act reduced the U.S. federal corporate tax rate from 35% to 21%. For the year ended December 31, 2017, this resulted in a $15.9
million reduction for the deferred tax assets related to net operating losses and other assets. Such reduction was offset by a
corresponding reduction to the Company’s valuation allowance.
In addition, the Act
repealed the corporate alternative minimum tax (“AMT”) for years beginning after December 31, 2017 and allowed companies
with existing alternative minimum tax credit (“MTC”) carryforwards as of December 31, 2017 to receive refunds of the
credits in tax years after 2017 and before 2022 in an amount equal to 50% (100% in 2021) of the excess MTC over the amount of the
credit allowable each year against regular tax liability.
As of December 31,
2017, the Company had $1.94 million in minimum tax credits and recorded a long term receivable for the future expected refunds
of the credits. As of December 31, 2018, the Company has reclassified $970,000 as a short term receivable, leaving a balance of
$970,000 as a long term receivable based on the expected timing of the refunds of the minimum tax credits.
The Company completed
the accounting for the tax impact of the Act as of December 31, 2017 and recorded no provisional amounts.
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, 2017, the Company believed
that it was more likely than not that future taxable income would not exist to utilize some or all of their deferred tax assets.
Accordingly, it recorded a valuation allowance in the amount of its total deferred tax assets for the period ended December 31,
2017. In 2018, the Company generated $5.8 million of taxable income, offset by the utilization of net operating loss carryforwards.
The deferred tax expense associated with the net operating loss utilization was offset in full by the tax benefit resulting from
the reduction in the associated valuation allowance. The Company has recorded a full valuation allowance against its remaining
deferred tax assets as of December 31, 2018, as it believes it is more likely than not that these assets will not be realized.
At December 31, 2018,
the Company had federal net operating loss carryforwards of approximately $100.6 million that expire in the years 2025 through
2036, and New Jersey state net operating loss carryforwards of approximately $22.9 million that expire in the years 2030 through
2038. Under the 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 Company
does not have federal net operating loss carryforwards generated in years beginning after December 31, 2016.
The Company had federal
and state capital loss carryforwards of approximately $1.2 million that expired in 2018. The Company also had federal research
and development (“R&D”) credit carryforwards of approximately $400,000 that expired in 2018. The Company has remaining
R&D credit carryforwards of approximately $16.2 million that expire in the years 2019 through 2029. These deferred tax assets
had been subject to a valuation allowance such that the deferred tax expense incurred as a result of the expiration of the capital
loss and R&D credit carryforwards was offset in full by a corresponding deferred tax benefit for the related reduction in valuation
allowance.
The Company’s
ability to use the net operating loss and R&D tax credit carryforwards may be limited, as it is subject to certain limitations
due to ownership changes as defined by rules pursuant to Section 382 of the Internal Revenue Code of 1986, as amended.
The Company has not
recorded a liability for unrecognized income tax benefits.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(CONTINUED)
|
(11)
|
Significant Agreements
|
Merck Agreement
As a result of a November
1990 agreement, the Company’s PEGylation technology was used to develop an improved version of the product INTRON A, PegIntron.
Merck is responsible for marketing and manufacturing PegIntron on an exclusive worldwide basis and the Company receives royalties
on worldwide sales of PegIntron for all indications. The Company has no involvement in the selling or marketing of PegIntron. Merck’s
obligation to pay the Company royalties on sales of PegIntron terminates, on a country-by-country basis, upon the later of the
date on which the last patent to contain a claim covering PegIntron expires in the country or 15 years after the first commercial
sale of PegIntron in such country. The expiration occurred in 2016 in the U.S., and expirations occurred in 2018 in Europe and
will expire in Malaysia in 2020, Japan in 2021 and Chile in 2024. The royalty percentage to which the Company is entitled will
be lower in any country where a PEGylated alpha-interferon product is being marketed by a third party in competition with PegIntron
where such third party is not Hoffmann-La Roche. Either party may terminate the agreement upon a material breach of the agreement
by the other party that is not cured within 60 days of written notice from the non-breaching party or upon declaration of bankruptcy
by the other party. During the quarter ended September 30, 2007, the Company sold a 25 -percent interest in future royalties payable
to it by Merck on net sales of PegIntron occurring after June 30, 2007. See Note 1 regarding Merck royalty revenues.
Servier Agreement
See Note 1 regarding
the Servier milestone obligation to the Company.
Nektar Agreement
See Note 1 regarding
the Nektar Second Amendment, wherein Nektar agreed to buy-out all remaining payment obligations to the Company under the Nektar
License Agreement.
|
(12)
|
Commitments and Contingent
Liabilities
|
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.
Principal Executive Offices and Office
Service Agreements
Commencing on March
1, 2016, the Company changed the location of its principal executive offices to 20 Commerce Drive, Suite 135, Cranford, New Jersey,
07016. The Company entered into an office service agreement with Regus for use of office space at this location effective March
1, 2016. Under the agreement, in exchange for the Company’s right to use the office space at this location, the Company was
required to pay Regus an initial service retainer of $2,418 and thereafter pay Regus a monthly fee of $1,209 until February 28,
2017. This agreement was renewed for two one-year extensions, until February 28, 2019, for a monthly fee of $1,259. In June 2018,
the Company and Regus agreed to end the lease on August 31, 2018, and replace it with an updated office service agreement. The
Company entered into an office service agreement with Regus for mailbox plus, telephone answering, and virtual office services
effective September 1, 2018. Under the agreement, in exchange for the services provided by Regus, the Company was required to pay
Regus an initial service retainer of $259 and thereafter pay Regus a monthly fee of $259 until August 31, 2019.
Effective July 1, 2018,
the Company entered into an office rental agreement with Equinox for use of office space at 3556 Main Street, Manchester, VT, 05225.
Under this agreement, in exchange for the Company’s right to use the office space at this location, the Company is required
to pay Equinox a monthly fee of $708 until June 30, 2019.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(CONTINUED)
|
(14)
|
Other Corporate Events
|
On February 4, 2016,
the Company’s Board of Directors adopted the Plan of Liquidation and Dissolution,
pursuant to which the Company 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 the State of Delaware. In approving the Plan of Liquidation and
Dissolution, the Company’s Board of Directors had considered, among other factors, the ability of the Company to obtain no-action
relief from the SEC to suspend certain of the Company’s reporting obligations under the Securities Exchange Act of 1934,
as amended, and the anticipated cost savings if such relief is granted by the SEC. After further consideration, the Company’s
Board of Directors determined that it would be fair, advisable and in the best interests of the Company and its stockholders to
postpone seeking stockholder approval of the Plan of Liquidation and Dissolution until a later time to be determined by the Company’s
Board of Directors.
From
time to time, the Company’s Board of Directors reviews the Company’s status and prospects in deciding on the timing
of dissolution and liquidation of the Company pursuant to the Plan of Liquidation and Dissolution. If the Company’s Board
of Directors determines to seek stockholder approval of such plan and such plan is approved by the Company’s stockholders
and implemented by the Company, it is expected that the Company’s corporate existence will continue for the purpose of winding
up its business and affairs for at least three years. The Company has forecasted minimal or no royalty or milestone revenues
for the foreseeable future. In light of the uncertainty as to whether any of the milestones under the Micromet Marketing Agreement
would be achieved, this forecast assumes that the Company would not receive any milestone or royalty payments under the Micromet
Marketing Agreement.
On April 30, 2014,
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 May 14, 2014.
The Section 382 Rights Agreement expired by its terms on April 30, 2017 and has not been replaced.
On
January 30, 2019, the Company’s Board of Directors declared a special cash dividend of $0.06 per share of the Company’s
common stock.
This special cash dividend, aggregating approximately $2.7 million, will be paid on March 21, 2019 to stockholders
of record as of February 21, 2019.