8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
___________
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
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Date of Report (Date of earliest event reported) May 7, 2008 |
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ENZON
PHARMACEUTICALS, INC. |
(Exact name of registrant as specified in its charter) |
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Delaware |
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0-12957 |
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22-2372868 |
(State or other jurisdiction of incorporation)
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(Commission File No.)
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(IRS Identification No.) |
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685 Route 202/206, Bridgewater, New Jersey |
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08807 |
(Address of principal executive offices)
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(Zip Code) |
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Registrants telephone number, including area code (908) 541-8600 |
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(Former name or former address, if changed since last report) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
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Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b) |
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Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Item 2.02 |
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Results of Operations and Financial Condition. |
On
May 7, 2008, Enzon Pharmaceuticals, Inc. (Enzon) issued a press release reporting certain
financial and other information for the quarter ended March 31. 2008. A copy of Enzons press
release dated May 7, 2008, is attached as Exhibit 99.1 to this Current Report and is incorporated
by reference into this Item 2.02.
The information in this Item 2.02, including Exhibit 99.1, is being furnished and shall not be
deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the
Exchange Act) or otherwise subject to the liability of that Section, nor shall such information
be deemed to be incorporated by reference into any registration statement or other document filed
under the Securities Act of 1933 or the Exchange Act, except as otherwise stated in that filing.
On
May 7, 2008, Enzon issued a press release announcing that its Board of Directors has authorized
a plan to spin-off its novel biotechnology business from Enzon in a transaction that will result in
two independent and highly focused public companies. A copy of
Enzons press release dated May 7,
2008, is attached as Exhibit 99.2 to this Current Report and is incorporated by reference into this
Item 8.01.
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Item 9.01 |
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Financial Statements and Exhibits. |
(d) Exhibits.
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Exhibit
No. |
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Description |
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99.1
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Press Release of Enzon
Pharmaceuticals, Inc. dated May 7, 2008 |
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99.2
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Press Release of Enzon
Pharmaceuticals, Inc. dated May 7, 2008 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated:
May 7, 2008
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By: |
/s/ Craig A. Tooman
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Craig A. Tooman |
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Executive Vice President, Finance
and
Chief Financial Officer |
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EX-99.1
Exhibit 99.1
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Contact:
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Craig Tooman |
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EVP, Finance and Chief Financial Officer |
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908-541-8777 |
ENZON REPORTS STRONG FIRST QUARTER 2008 RESULTS
BRIDGEWATER, NJ May 7, 2008 Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced strong
first quarter 2008 financial results. For the three months ended March 31, 2008, Enzon reported a
net income of $1.5 million or $0.03 per diluted share, as compared to a net loss of $2.8 million or
$0.06 per diluted share for the first quarter of 2007. The Companys first quarter 2008 results
were positively impacted by strong revenues across all business segments.
The Company continues to generate strong top-line results across all of our business segments,
said Jeffrey H. Buchalter, chairman and chief executive officer of Enzon. Earlier today, we
announced a plan to spin-off our biotechnology business. The spin-off, upon completion, will allow
the two independent companies to focus on their core competencies and appeal to their own unique
shareholders.
Recent Highlights
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The Company reduced a significant portion of its 2008 debt ahead of the required
timeline to only $12.5 million. |
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PEG-SN38 was featured in the March 15th issue of Clinical Cancer Research
published by the American Association for Cancer Research, Inc. (AACR). |
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The Company presented preclinical data on the HIF-1alpha antagonist at the 2008 AACR
annual meeting in San Diego, California. |
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The Company closed its Phase I trial evaluating Oncaspar® in combination with
Gemzar® for patients with solid tumors and lymphoma. |
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In April, Cimzia®, which utilizes Enzons PEGylation technology, was approved
in the U.S. for the treatment of moderate to severe Crohns disease. |
Revenues
The following table reflects the revenues generated by product and segment for the three month
periods ended March 31, 2008 and 2007.
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Three Months Ended |
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(in thousands) |
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March 31, 2008 |
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March 31, 2007% |
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Change |
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Products |
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Oncaspar |
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$ |
12,288 |
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$ |
7,467 |
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65 |
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DepoCyt |
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1,968 |
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2,369 |
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(17 |
) |
Abelcet |
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7,020 |
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7,686 |
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(9 |
) |
Adagen |
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6,153 |
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5,127 |
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20 |
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Total Products |
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27,429 |
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22,649 |
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21 |
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Royalties |
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14,700 |
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16,344 |
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(10 |
) |
Contract Manufacturing |
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6,644 |
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2,495 |
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166 |
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Total Revenues |
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$ |
48,773 |
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$ |
41,488 |
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18 |
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Products Segment
Product segment sales comprised of sales of Oncaspar®, DepoCyt®, Abelcet®, and Adagen®, increased 21 percent to $27.4 million for the
three months ended March 31, 2008, compared to $22.7 million for the three months ended March 31,
2007. The growth was mainly attributable to higher revenues from the Companys oncology product,
Oncaspar. The product benefited from a $1.2 million international shipment in the first quarter of
2008, which did not occur in the first quarter of 2007. Sales of Oncaspar are reflective of a price
increase and the continued adoption in certain protocols by hospitals and cooperative groups. Sales
of DepoCyt, for treatment of lymphomatous meningitis and sales of Adagen, for treatment of Severe
Combined Immunodeficiency Disease (SCID), tend to fluctuate from quarter-to-quarter due to the
small number of patients treated. The decline in Abelcet, for the treatment of invasive fungal
infections, continues to be attributable to competitive pressures in the marketplace, although the
rate of decline this quarter is lower than the quarterly average in the last year.
Royalties Segment
Revenues from the Companys royalties segment for the three months ended March 31, 2008 decreased
to $14.7 million, as compared to $16.3 million for the three months ended March 31, 2007. The
reduction in royalties from the prior year was due to the partial PEG-INTRON monetization which
occurred in August 2007. This resulted in a 25% reduction in royalties we received on PEG-INTRON.
This decrease is partially offset by the underlying growth in PEG-INTRON. In April 2008, Cimzia was
approved by the FDA for the treatment of moderate to severe Crohns disease. The product was
developed and will be marketed by UCB. Since Cimzia utilizes Enzons PEGylation technology, Enzon
is entitled to royalties on its net sales.
-2-
Contract Manufacturing Segment
The Companys revenues from its contract manufacturing segment increased to $6.6 million for the
three months ended March 31, 2008, as compared to $2.5 million for the comparable period of 2007.
The increase in contract manufacturing revenue was the combined result of the timing of shipments
to customers and additional non-routine services provided to our existing customers. Due to the
timing of shipments, quarter-to-quarter variability is not uncommon and it is not anticipated that
the level of sales achieved this quarter will continue throughout the year.
Cost of Product Sales and Contract Manufacturing
The Companys cost of goods sold was $16.1 million for the three months ended March 31, 2008,
compared to $11.5 million for the three months ended March 31, 2007. The increase is a direct
result of the increase in products sales and contract manufacturing revenues for the first quarter
of 2008.
Research and Development
Research and development spending was relatively flat this quarter compared to the corresponding
quarter in 2007. As previously disclosed, the Company is increasing efforts to transfer the raw
material and improve the pharmaceutical properties of Oncaspar and Adagen. These enhancements will
require investment in both products for the next few years. As previously noted, the Company
decided to close its Phase I study of Oncaspar. The decision was made after dose limiting
toxicities were observed for the combination of Oncaspar and Gemzar for patients with various solid
tumors and lymphoma. Despite Enzons decision not to advance the clinical development of Oncaspar,
investigators remain interested in exploring Oncaspars use in solid tumors through their own
studies. The Company also continues to enroll patients in its HIF-1alpha antagonist, PEG-SN38 and
rhMBL programs. Data from these programs will be available at major medical meetings throughout the
year.
Selling, General and Administrative
Selling, general and administrative expense decreased to $15.4 million for the three months ended
March 31, 2008 from $17.1 million in the year earlier quarter. This was due primarily to the first
quarter 2007 vesting of certain stock option awards not recurring in first quarter 2008. The
Company continues to make select investments in selling, marketing, and other initiatives to
support its product sales performance. As previously mentioned, during the fourth quarter of 2007,
the Company proactively realigned its sales territories and refocused the sales force to promote
the Enzon marketed brands.
-3-
Restructuring Charge
The Company continues to consolidate manufacturing operations in its Indianapolis, Indiana
location. All operations at the Companys South Plainfield, New Jersey facility are expected to be
transferred to the Companys Indianapolis facility in 2008, resulting in the incurrence of certain
restructuring and exit costs. Among these costs will be employee severance and related benefits for
affected employees. In connection with our restructuring program for the three months ended March
31, 2008 the Company incurred a total cost of $1.3 million compared to $0.6 million for the three
months ended March 31, 2007.
Other Income (Expense)
Other (income) expense for the three months ended March 31, 2008 was net expense of $0.9 million,
as compared to net expense of $1.9 million for the three months ended March 31, 2007. Other
(income) expense includes: net investment income, interest expense and other income or expense. The
decrease was principally due to interest expense, which includes amortization of deferred offering
costs. Interest expense was $3.4 million for the three months ended March 31, 2008 and $4.6 million
for the three months ended March 31, 2007 reflecting the declining balance of the Companys 4.5%
notes payable. Net investment income was relatively constant at $2.2 million for the three months
ended March 31, 2008 compared to $2.6 million for the three months ended March 31, 2007.
Cash and Investments
Total cash reserves, which include cash, cash equivalents, short-term investments,
marketable securities, and restricted investments and cash, were $198.8 million as of March 31,
2008, as compared to $258.2 million as of December 31, 2007. During the first quarter of 2008, the
Company purchased $59.9 million of its existing 2008 convertible notes leaving a balance of $12.5
million of 2008 notes due. As of March 31, 2008, $14.5 million was held in a restricted cash
account for the sole purpose of extinguishing the remaining outstanding 2008 debt.
-4-
Conference Call and Webcast
Enzon will be hosting a live conference call today, May 7 at 10:00 am EST. All interested parties
may access the call by using the following information:
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Domestic Dial-In Number:
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(866) 334-3876 |
International Dial-In Number:
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(416) 849-4292 |
Access Code:
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Enzon |
Enzons conference call will also be available via live audio webcast at
www.investorcalendar.com. For those unable to attend the live audio webcast, a replay will be
available beginning approximately one hour after the event. Additionally, a telephonic rebroadcast
will be available following the call. The rebroadcast will begin on Wednesday, May 7, 2008, at
approximately 12:00 p.m. EST and end on May 14, 2008, at approximately 12:00 p.m. EST. The
rebroadcast may be accessed using the following information:
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Domestic Dial-In Number: |
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(866) 245-6755 |
International Dial-In Number: |
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(416) 915-1035 |
Access Code: |
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809911 |
About Enzon
Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development,
manufacturing, commercialization of important medicines for patients with cancer and other
life-threatening conditions. Enzon has a portfolio of four marketed products, Oncaspar®,
DepoCyt®, Abelcet® and Adagen®. The Companys drug development
programs utilize several cutting-edge approaches, including its industry-leading PEGylation
technology platform used to create product candidates with benefits such as reduced dosing
frequency and less toxicity. Enzons PEGylation technology was used to develop two of its products,
Oncaspar and Adagen, and has created a royalty revenue stream from licensing partnerships for other
products developed using the technology. Enzon also engages in contract manufacturing for several
pharmaceutical companies to broaden the Companys revenue base. Further information about Enzon and
this press release can be found on the Companys web site at www.enzon.com.
Forward Looking Statements
There are forward-looking statements contained herein, which can be identified by the use of
forward-looking terminology such as the words believes, expects, may, will, should,
potential, anticipates, plans, or intends and similar expressions. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors that may cause actual
results, events or developments to be materially different from the future results, events or
developments indicated in such forward-looking statements. Such factors include, but are not
limited to the timing, success and cost of clinical studies; the ability to obtain regulatory
approval of products, market acceptance of, and continuing demand for, Enzons products and the
impact of competitive products and pricing. A more detailed discussion of these and other factors
that could affect results is contained in our filings with the U.S. Securities and Exchange
Commission, including our annual report on Form 10-K for the period ended December 31, 2007. These
factors should be considered carefully and readers are cautioned not to place undue reliance on
such forward-looking statements. No assurance can be given that the future results covered by the
forward-looking statements will be achieved. All information in this press release is as of the
date of this press release and Enzon does not intend to update this information.
-5-
Enzon Pharmaceuticals, Inc. and Subsidiaries
Consolidated Statements of Operations
Three Months ended March 31, 2008 and March 31, 2007
(In thousands, except per share amounts)
(Unaudited)
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March 31, |
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March 31, |
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2008 |
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2007 |
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Revenues: |
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Product sales, net |
|
$ |
27,429 |
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|
$ |
22,649 |
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Royalties |
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|
14,700 |
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|
16,344 |
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Contract manufacturing |
|
|
6,644 |
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|
2,495 |
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|
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Total revenues |
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48,773 |
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|
41,488 |
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Costs and expenses: |
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Cost of product sales and contract manufacturing |
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16,139 |
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|
11,464 |
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Research and development |
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13,184 |
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|
13,240 |
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Selling, general and administrative |
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15,393 |
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|
17,123 |
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Amortization of acquired intangible assets |
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|
167 |
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185 |
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Restructuring charge |
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1,254 |
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569 |
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Total costs and expenses |
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46,137 |
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|
42,581 |
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Operating income (loss) |
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2,636 |
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(1,093 |
) |
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Other income (expense): |
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Investment income, net |
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2,179 |
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|
2,577 |
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Interest expense |
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(3,385 |
) |
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(4,553 |
) |
Other, net |
|
|
296 |
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90 |
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(910 |
) |
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(1,886 |
) |
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Income (loss) before income tax provision (benefit) |
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1,726 |
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(2,979 |
) |
Income tax provision (benefit) |
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210 |
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(193 |
) |
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Net income (loss) |
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$ |
1,516 |
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$ |
(2,786 |
) |
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Earnings (loss) per common share basic |
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$ |
0.03 |
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$ |
(0.06 |
) |
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Earnings (loss) per common share diluted |
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$ |
0.03 |
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$ |
(0.06 |
) |
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Weighted average shares basic |
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44,166 |
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|
43,862 |
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Weighted average shares diluted |
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|
44,737 |
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43,862 |
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-6-
Enzon Pharmaceuticals, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
March 31, 2008 and December 31, 2007
(In thousands)
(Unaudited)
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March 31, |
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December 31, |
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2008 |
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2007 |
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Assets |
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Current assets: |
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Cash and short-term investments |
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$ |
129,054 |
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$ |
163,960 |
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Restricted investments and cash |
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|
14,452 |
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|
73,592 |
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Accounts receivable, net |
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|
16,199 |
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|
14,927 |
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Inventories |
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|
19,284 |
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|
22,297 |
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Other current assets |
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|
7,966 |
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|
6,401 |
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Total current assets |
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|
186,955 |
|
|
|
281,177 |
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Property and equipment, net |
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|
45,269 |
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|
45,312 |
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Other assets: |
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Marketable securities |
|
|
55,308 |
|
|
|
20,653 |
|
Amortizable intangible assets, net |
|
|
65,559 |
|
|
|
68,141 |
|
Other assets |
|
|
4,798 |
|
|
|
5,074 |
|
|
|
|
|
|
|
|
|
|
|
125,665 |
|
|
|
93,868 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
357,889 |
|
|
$ |
420,357 |
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|
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|
Liabilities and Stockholders Equity |
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Current liabilities: |
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|
|
|
|
|
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Accounts payable and accrued expenses |
|
$ |
26,618 |
|
|
$ |
33,091 |
|
Notes payable |
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|
12,521 |
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|
72,391 |
|
|
|
|
|
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Total current liabilities |
|
|
39,139 |
|
|
|
105,482 |
|
|
|
|
|
|
|
|
Notes payable |
|
|
275,000 |
|
|
|
275,000 |
|
Other liabilities |
|
|
3,637 |
|
|
|
3,302 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
317,776 |
|
|
|
383,784 |
|
|
|
|
|
|
|
|
Stockholders equity |
|
|
40,113 |
|
|
|
36,573 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
357,889 |
|
|
$ |
420,357 |
|
|
|
|
|
|
|
|
Common shares outstanding |
|
|
44,659 |
|
|
|
44,200 |
|
|
|
|
|
|
|
|
-7-
EX-99.2
Exhibit 99.2
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|
Contact:
|
|
Craig Tooman |
|
|
EVP, Finance and Chief Financial Officer |
|
|
908-541-8777 |
ENZON PHARMACEUTICALS, INC. ANNOUNCES PLAN TO SPIN-OFF
BIOTECHNOLOGY BUSINESS
BRIDGEWATER, N.J., May 7, 2008 (BUSINESS WIRE) Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today
announced that its Board of Directors has authorized a plan to spin-off its novel biotechnology
business from Enzon in a transaction that will result in two independent and highly focused public
companies.
By separating these unique businesses into two focused companies, the opportunities for both
the specialty pharmaceutical business and the biotechnology business could be substantially
enhanced and greater value could be created than under the current structure, said Jeffrey H.
Buchalter, Chairman, President and CEO. Operating separately will allow each company to benefit
from greater strategic and managerial focus and appeal to their own unique shareholders. The
separation will enable the two businesses to compete more effectively in their respective markets
and optimize their business goals, research initiatives and capital requirements. We look forward
to creating this opportunity for the shareholders, said Mr. Buchalter.
Upon completion of the spin-off, Mr. Buchalter will serve as Chairman, President and CEO of the new
biotechnology company and Craig Tooman, the current CFO of Enzon, will assume the role of President
and CEO of Enzon. Each company will operate with independent management teams and additional
details regarding management structure will be determined and disclosed at a later time.
Following the spin-off of the biotechnology company, Enzon will retain the current marketed
products of Abelcet®, Adagen®, DepoCyt® and Oncaspar®,
the rights to current PEG royalty revenues, including PEG-Intron®, Cimzia®
and Hematide®, and the manufacturing facility in Indianapolis. The Company expects that
the functional support associated with these operations will continue at Enzon. In addition,
Enzons outstanding convertible notes would remain as obligations of the company.
The specialty pharmaceutical business will continue its long-standing track record in providing
life saving therapies for patients. The business has strong fundamentals, including stable
revenue, cash flow, and strong assets, said Mr. Buchalter. Upon completion of the spin-off,
Enzon will have the resources to better focus its strategy and compete more effectively in the
specialty pharmaceutical market.
The biotechnology company resulting from the spin-off will continue to leverage its customized
PEGylation technology for licensing, collaboration and future royalty generation, and novel Locked
Nucleic Acid (LNA) technology to develop promising therapeutics for oncology. Enzon expects to
sufficiently capitalize the new company with approximately $150 million of cash, representing
approximately two to three years of anticipated cash need to fund research and development efforts
based on company projections.
The spin-off of the biotechnology business will permit this entity to become a highly focused
biotechnology company, strategically concentrating on its new PEGylation and novel LNA technology
platforms to better develop progressive therapeutics, such as PEG-SN38, HIF1-alpha and rhMBL, for
patients with life-threatening oncology conditions. With a better focus on our development
efforts, the biotechnology business will be uniquely positioned to forge new paradigms of oncology
therapy, said Mr. Buchalter.
Completion of the proposed spin-off is subject to numerous conditions, including final approval by
Enzons Board of Directors, the filing and effectiveness of a registration statement with the
Securities and Exchange Commission (SEC) and any necessary third-party consents. Enzon is
currently evaluating whether or not the proposed spin-off would qualify as a tax-free stock
distribution. Enzon has retained Goldman, Sachs & Co. as financial advisor, Skadden, Arps, Slate,
Meagher & Flom LLP as legal advisor and Mercer as human capital consultant with respect to the
spin-off transaction, which is expected to be completed in the fourth quarter of 2008.
About Enzon
Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development,
manufacturing, commercialization of important medicines for patients with cancer and other
life-threatening conditions. Enzon has a portfolio of four marketed products, Oncaspar®,
DepoCyt®, Abelcet® and Adagen®. The Companys drug development
programs utilize several cutting-edge approaches, including its industry-leading PEGylation
technology platform used to create product candidates with benefits such as reduced dosing
frequency and less toxicity. Enzons PEGylation technology was used to develop two of its products,
Oncaspar and Adagen, and has created a royalty revenue stream from licensing partnerships for other
products developed using the technology. Enzon also engages in contract manufacturing for several
pharmaceutical companies to broaden the Companys revenue base. Further information about Enzon and
this press release can be found on the Companys web site at www.enzon.com.
Forward Looking Statements
There are forward-looking statements contained herein, which can be identified by the use of
forward-looking terminology such as the words believes, expects, may, will, should,
potential, anticipates, plans, or intends and similar expressions. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors that may cause actual
results, events or developments to be materially different from the future results, events or
developments indicated in such forward-looking statements. Such factors include, but are not
limited to the timing, success and cost of clinical studies; the ability to obtain regulatory
approval of products, market acceptance of, and continuing demand for, Enzons products and the
impact of competitive products and pricing. A more detailed discussion of these and other factors
that could affect results is contained in our filings with the U.S. Securities and Exchange
Commission, including our annual report on Form 10-K for the period ended December 31, 2007. These
factors should be considered carefully and readers are cautioned not to place undue reliance on
such forward-looking statements. No assurance can be given that the future results covered by the
forward-looking statements will be achieved. All information in this press release is as of the
date of this press release and Enzon does not intend to update this information.
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