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
Date of Report (Date of earliest event reported) August 6, 2008
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 |
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(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 |
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(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number, including area code
(908) 541-8600
(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)) |
TABLE OF CONTENTS
Item 2.02 Results of Operations and Financial Condition.
On August 6, 2008, Enzon Pharmaceuticals, Inc. issued a press release reporting certain financial
and other information for the quarter ended June 30, 2008. A copy of the press release 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.
Item 9.01 Financial Statements and Exhibits.
(c) 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 August 6, 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: August 6, 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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For Immediate Release |
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Contact:
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Craig Tooman |
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EVP, Finance and Chief |
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Financial Officer |
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908-541-8777 |
ENZON REPORTS SOLID SECOND QUARTER 2008 RESULTS
Product revenues increase 17%
BRIDGEWATER, NJ August 6, 2008 Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced solid
second quarter 2008 financial results. For the three months ended June 30, 2008, Enzon reported a
net loss of $1.7 million or $0.04 on a diluted per-share basis, as compared to a net loss of $2.0
million or $0.04 per diluted share for the second quarter of 2007. The Companys results continue
to be positively impacted by strong revenues across all business segments.
Our strong performance this quarter is a direct result of our well-executed business plan, said
Jeffrey H. Buchalter, chairman and chief executive officer of Enzon. The Company continues to
drive initiatives to expand the business and advance the pipeline to enhance shareholder value.
Recent Highlights
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The Company repaid all of its remaining 2008 debt in July. |
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The Company presented new clinical data from the PEG-SN38 Phase 1 study and the
recombinant human Mannose-Binding Lectin (rhMBL) clinical study at the 2008 ASCO annual
meeting in Chicago, Illinois. |
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The Company continues to advance the proposed spin-off of its R&D pipeline into a
separate company. |
Revenues
The following table reflects the revenues generated by product and segment for the three month
periods ended June 30, 2008 and 2007.
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Three Months Ended |
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(in thousands) |
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June 30, 2008 |
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June 30, 2007 |
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% Change |
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Products |
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Oncaspar |
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$ |
13,183 |
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$ |
9,673 |
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36 |
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DepoCyt |
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2,368 |
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2,080 |
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14 |
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Abelcet |
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6,644 |
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6,716 |
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(1 |
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Adagen |
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7,011 |
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6,550 |
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7 |
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Total Products |
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29,206 |
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25,019 |
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17 |
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Royalties |
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15,035 |
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18,290 |
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(18 |
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Contract Manufacturing |
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6,723 |
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5,903 |
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14 |
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Total Revenues |
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$ |
50,964 |
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$ |
49,212 |
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4 |
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Products Segment
For the three months ended June 30, 2008, net product sales increased to $29.2 million or 17% over
the same period of 2007. This quarter, the Company experienced growth in the sales of Oncaspar®,
DepoCyt® and Adagen®. Sales of Abelcet® were relatively stable during the second quarter of 2008
as compared to the second quarter of 2007.
The 36% increase in revenue for the Companys oncology product, Oncaspar, during the three months
ended June 30, 2008, as compared to the three months ended June 30, 2007, was driven in part by a
13% growth in volume. Oncaspar continues to be adopted in cooperative protocols for the first-line
treatment of patients with acute lymphoblastic leukemia for both pediatric and adult patients.
Sales of DepoCyt, for treatment of lymphomatous meningitis, and Adagen, for treatment of severe
combined immuno-deficiency disease, tend to fluctuate from quarter to quarter due to their small
patient bases.
Royalties Segment
Total royalties were $15.0 million for the three months ended June 30, 2008 compared to $18.3
million during the comparable three-month period ended June 30, 2007. Despite the sale of 25% of
the royalty interest in PEG-INTRON in August 2007, royalties decreased only 18%, demonstrating a
continued growth in the products from which the Company receives royalties.
-2-
Contract Manufacturing Segment
The Companys revenues from its contract manufacturing segment increased to $6.7 million for the
three months ended June 30, 2008, as compared to $5.9 million for the comparable period of 2007.
The increase in contract manufacturing revenue was the result of the timing of shipments to
customers, which often causes quarter-to-quarter variability. It is not anticipated that the level
of sales achieved this quarter will continue throughout the year. However, the Company has been
successful in securing two new customers since 2006, which has contributed to the annual increase
in revenues.
Cost of Product Sales and Contract Manufacturing
The Companys cost of goods sold was $17.4 million for the three months ended June 30, 2008,
compared to $15.3 million for the three months ended June 30, 2007. Included in the second quarter
of 2008, were amortization costs of $1.9 million related to a $5.0 million sales milestone in
connection with the 2006 amendment of the Oncaspar license. In 2007, validation costs of $1.9
million were incurred in the quarter ended June 30 related to certain production batches associated
with the consolidation of the Companys products from its South Plainfield, New Jersey location to
its Indianapolis, Indiana facility. Excluding these costs from both periods, the gross margin was
relatively unchanged from year to year.
Research and Development
For the three months ended June 30, 2008, research and development expenses were $14.1 million as
compared to $16.9 million for the three months ended June 30, 2007. The decrease of R&D expenses
this quarter is primarily a result of the timing of certain R&D expenses. In 2007, the Company
incurred costs associated with the start-up of clinical trials, including the purchase of clinical
drug supply. The Company continues to invest in its research and development pipeline in areas
such as rhMBL, PEG-SN38, the HIF-1 alpha antagonist and other LNA and PEGylation based programs.
The Company anticipates increased levels of R&D expenses in the second half of 2008 as it continues
to advance its clinical development programs. Included in the $14.1 million of expenses in 2008 is
$2.0 million in milestones achieved during the quarter related to the LNA platform. As previously
stated, the Company expects to achieve up to $10 million in milestones this year. As the data is
available, the Company will continue to provide updates on the programs at major medical meetings,
as seen recently at the 2008 ASCO meeting.
Selling, General and Administrative
Selling, general and administrative expense increased to $18.1 million for the three months ended
June 30, 2008 from $16.0 million in 2007. This was due primarily to costs associated with the
Companys proposed spin-off of the R&D activities into a separate company. These costs are
expected to continue until the transaction is complete, which is expected to be in the fourth
quarter of 2008, subject to final approval from the SEC and Board of Directors. The Company also
continues to selectively invest in selling expenses for the current marketed products.
-3-
Restructuring Charge
The Companys consolidation of the manufacturing operations is going well. The consolidation of all
operations at the Companys South Plainfield, New Jersey facility are proceeding according to plan
and are expected to be transferred to the Companys Indianapolis facility in 2008. In connection
with the restructuring program for the three months ended June 30, 2008 the Company incurred a
total cost of $0.9 million compared to $0.8 million for the three months ended June 30, 2007.
These costs included employee severance and related benefits for affected employees.
Other Income (Expense)
Other (income) expense for the three months ended June 30, 2008 was net expense of $2.0 million, as
compared to net expense of $1.8 million for the three months ended June 30, 2007. Other (income)
expense includes: net investment income, interest expense and other income or expense. The change
was principally due to lower investment income partially offset by reduced interest expense. Net
investment income declined to $1.1 million for the three months ended June 30, 2008 compared to
$2.4 million for the three months ended June 30, 2007. This change was a result of the decrease in
investments as a result of the repurchase of the outstanding 4.5% notes. Interest expense was $3.2
million for the three months ended June 30, 2008 and $4.5 million for the three months ended June
30, 2007 reflecting the declining balance of the Companys 4.5% notes payable.
Cash and Investments
Total cash reserves, which include cash, short-term investments, restricted investments and cash
and marketable securities, were $205.9 million as of June 30, 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 4.5% notes due in 2008. As previously mentioned, the Company repaid the remaining
2008 debt in July.
-4-
Adjusted Financial Results
For the three months ended June 30, 2008, Enzon reported an adjusted net loss of $0.6 million or
$0.01 per diluted share, as compared to an adjusted net loss of $2.0 million or $0.04 per diluted
share for the three months ended June 30, 2007.
The following table reconciles the Companys net loss and net loss per diluted share as determined
in accordance with U.S. generally accepted accounting principles (GAAP) to its adjusted net loss
and net loss per diluted share for the three months ended June 30, 2008 and 2007 respectively:
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Three Months Ended |
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(in thousands, except per-share amounts) |
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June 30, 2008 |
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June 30, 2007 |
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Net |
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Net loss |
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loss per |
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Net |
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per diluted |
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Net |
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diluted |
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loss |
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share |
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loss |
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share |
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GAAP net loss |
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$ |
(1,745 |
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$ |
(0.04 |
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$ |
(1,959 |
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$ |
(0.04 |
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Adjustment to GAAP net loss: |
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Add: Costs related with the proposed
spin-off of biotechnology activities
(1) |
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1,140 |
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0.03 |
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Less: Gain related to the repurchase of
debt(2) |
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73 |
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Adjusted net loss (3) |
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$ |
(605 |
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$ |
(0.01 |
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$ |
(2,032 |
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$ |
(0.04 |
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(1) |
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Adjusted financial results for the second quarter of 2008 exclude the costs related
with the Companys expected spin-off of its research and development activities. |
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(2) |
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The Companys adjusted financial results for the second quarter of 2007 exclude a gain
related to the repurchase of the 4.5% Notes. |
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(3) |
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Adjusted net income (loss) and adjusted net income (loss) per share, as Enzon defines
them, may differ from similarly named measures used by other entities, and consequently, could be
misleading unless all entities calculated and defined such items in the same manner. The Company
believes that investors understanding of its performance is enhanced by disclosing adjusted net income
(loss) and adjusted net income (loss) per share reflecting adjustments for certain items that the
Company deems to be non-recurring. |
-5-
Conference Call and Webcast
Enzon will be hosting a live conference call today, August 6, 2008 at 9:00 am EDT. 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, August 6, 2008, at approximately
12:00 p.m. EDT and end on August 13, 2008, at approximately 12:00 p.m. EDT. 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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838709 |
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.
-6-
Enzon Pharmaceuticals, Inc. and Subsidiaries
Consolidated Statements of Operations
Three Months ended June 30, 2008 and 2007
(In thousands, except per share amounts)
(Unaudited)
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June 30, |
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June 30, |
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2008 |
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2007 |
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Revenues: |
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Product sales, net |
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$ |
29,206 |
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$ |
25,019 |
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Royalties |
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15,035 |
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18,290 |
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Contract manufacturing |
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6,723 |
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5,903 |
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Total revenues |
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50,964 |
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49,212 |
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Costs and expenses: |
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Cost of product sales and contract manufacturing |
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17,406 |
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15,269 |
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Research and development |
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14,056 |
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16,921 |
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Selling, general and administrative |
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18,070 |
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15,982 |
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Amortization of acquired intangible assets |
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166 |
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185 |
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Restructuring charge |
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889 |
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755 |
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Total costs and expenses |
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50,587 |
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49,112 |
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Operating income |
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377 |
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100 |
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Other income (expense): |
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Investment income, net |
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1,120 |
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2,366 |
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Interest expense |
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(3,181 |
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(4,491 |
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Other, net |
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24 |
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327 |
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(2,037 |
) |
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(1,798 |
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Loss before income tax provision |
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(1,660 |
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(1,698 |
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Income tax provision |
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85 |
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261 |
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Net loss |
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$ |
(1,745 |
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$ |
(1,959 |
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Loss per common share basic |
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$ |
(0.04 |
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$ |
(0.04 |
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Loss per common share diluted |
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$ |
(0.04 |
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$ |
(0.04 |
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Weighted average shares basic |
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44,352 |
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43,884 |
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Weighted average shares diluted |
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44,352 |
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43,884 |
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-7-
Enzon Pharmaceuticals, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
June 30, 2008 and December 31, 2007
(In thousands)
(Unaudited)
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June 30, |
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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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$ |
119,292 |
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$ |
163,960 |
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Restricted investments and cash |
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14,561 |
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73,592 |
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Accounts receivable, net |
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17,039 |
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14,927 |
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Inventories |
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20,044 |
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22,297 |
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Other current assets |
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6,272 |
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6,401 |
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Total current assets |
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177,208 |
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|
281,177 |
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Property and equipment, net |
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45,012 |
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|
45,312 |
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Other assets: |
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Marketable securities |
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72,045 |
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|
20,653 |
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Amortizable intangible assets, net |
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66,077 |
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|
68,141 |
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Other assets |
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|
4,523 |
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|
5,074 |
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|
142,645 |
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93,868 |
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Total assets |
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$ |
364,865 |
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$ |
420,357 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
32,711 |
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$ |
33,091 |
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Notes payable |
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12,521 |
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|
72,391 |
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Total current liabilities |
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45,232 |
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|
105,482 |
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|
|
|
|
Notes payable |
|
|
275,000 |
|
|
|
275,000 |
|
Other liabilities |
|
|
3,807 |
|
|
|
3,302 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
324,039 |
|
|
|
383,784 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity |
|
|
40,826 |
|
|
|
36,573 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
364,865 |
|
|
$ |
420,357 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common shares outstanding |
|
|
44,840 |
|
|
|
44,200 |
|
|
|
|
|
|
|
|
-8-