Innovative pipeline continues to progress
Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced its financial
results for the second quarter of 2009. For the three months ended June
30, 2009, Enzon reported a net loss of $5.1 million or $0.11 per diluted
share, as compared to a net loss of $1.7 million or $0.04 per diluted
share for the second quarter of 2008. The 2009 financial results were
impacted by the anticipated investment in R&D including PEG-SN38 and the
next-generation Oncaspar program, as well as lower royalty and contract
manufacturing revenues.
“We are pleased with the advancement of our innovative pipeline,
particularly our novel PEG-SN38 compound, which is now enrolling
patients in Phase II,” said Jeffrey H. Buchalter, President and Chief
Executive Officer of the Company. “We have also made good progress in
our next-generation Oncaspar program. The lifecycle sourcing programs
are designed to improve the current versions of the marketed products
and are required to continue to supply patients with these life-saving
drugs.”
Recent Operating Highlights
-
A comprehensive, randomized Phase II trial evaluating PEG-SN38 in
metastatic colorectal cancer patients was initiated in June and is
currently enrolling patients.
-
The Company presented data on its HIF-1 alpha antagonist Phase I
program at the American Society of Clinical Oncologists (ASCO)
demonstrating that the compound was well tolerated in multiple solid
tumor cancer types.
-
The Company was successful in transferring and qualifying the improved
Oncaspar raw material process to a Contract Manufacturing Organization
(CMO). The pivotal trial required for regulatory approval for the
next-generation Oncaspar in acute lymphoblastic leukemia (ALL)
patients is ongoing.
Revenues
The following table reflects the revenues generated by product and
segment for the three-months ended June 30, 2009 and 2008.
|
|
|
Three Months Ended
(in millions)
|
|
|
|
June 30, 2009
|
|
June 30, 2008
|
|
% Change
|
|
Products
|
|
|
|
|
|
|
|
Oncaspar
|
|
$
|
14.0
|
|
$
|
13.2
|
|
6
|
|
|
DepoCyt
|
|
|
2.6
|
|
|
2.4
|
|
8
|
|
|
Abelcet
|
|
|
5.5
|
|
|
6.6
|
|
(17
|
)
|
|
Adagen
|
|
|
7.8
|
|
|
7.0
|
|
11
|
|
|
Total Products
|
|
|
29.9
|
|
|
29.2
|
|
2
|
|
|
|
|
|
|
|
|
|
|
Royalties
|
|
|
13.9
|
|
|
15.0
|
|
(7
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract Manufacturing
|
|
|
3.4
|
|
|
6.8
|
|
(50
|
)
|
|
|
|
|
|
|
|
|
|
Total Revenues
|
|
$
|
47.2
|
|
$
|
51.0
|
|
(7
|
)
|
Products Segment
Sales from the Products segment, comprised of Oncaspar®,
DepoCyt®, Abelcet®, and Adagen®,
increased to $29.9 million for the three months ended June 30, 2009,
from $29.2 million for the three months ended June 30, 2008.
Sales of Oncaspar, a PEG-enhanced version of L-asparaginase, increased
6% to $14.0 million for the three months ended June 30, 2009, as
compared to $13.2 million for the three months ended June 30, 2008.
Oncaspar remains the gold standard of care for pediatric ALL. The
Company continues to see adoption in the adult and young adult
populations. The Company had a single digit price increase in January
2009 which contributed to the increase.
Sales of DepoCyt, a sustained-release formulation of the
chemotherapeutic agent cytarabine arabinoside or ara-C, increased to
$2.6 million for the three months ended June 30, 2009, as compared to
$2.4 million for the three months ended June 30, 2008. This is a small
patient population, so quarterly variability is not uncommon. The
Company had a single digit price increase in January 2009 which
contributed to the increase.
Sales in the U.S. and Canada of Abelcet, a lipid complex formulation of
amphotericin B used primarily in the hospital to treat
immuno-compromised patients with invasive fungal infections, for the
three months ended June 30, 2009 were $5.5 million as compared to $6.6
million in the same period of 2008. This brand continues to experience
competitive pressure in the anti-fungal market, in both volume and
price. The Abelcet average selling price has declined by 3% from the
second quarter of 2008.
Sales of Adagen, an enzyme replacement therapy used to treat adenosine
deaminase (ADA) deficiency in patients with severe combined
immuno-deficiency disease, increased to $7.8 million for the three
months ended June 30, 2009 from $7.0 million in the second quarter of
2008. This is a small, targeted patient population, so quarterly
variability is not uncommon. The Company also had a single digit price
increase in January 2009.
Royalties Segment
Revenues from the Company’s Royalties segment for the three months ended
June 30, 2009 were $13.9 million, as compared to $15.0 million for the
three months ended June 30, 2008. Royalties on PEG-INTRON, marketed by
Schering-Plough, continue to comprise the majority of the Company’s
royalty revenue. Schering-Plough reported in the first quarter of 2009 a
2% operational growth which was more than offset by a decline in foreign
exchange.
Contract Manufacturing Segment
The Company’s revenues from its Contract Manufacturing segment decreased
to $3.4 million for the three months ended June 30, 2009, as compared to
$6.8 million in the corresponding period of the prior year. This
includes contract manufacturing revenues related to services the Company
provides for customers who require fill and finish of injectable and
inhalation therapy products. The decrease is due largely to a delay in
shipment of certain CMO product that is requiring additional testing by
the customer. Timing of production and shipments to customers often
cause quarter-to-quarter variability.
Cost of Product Sales and Contract
Manufacturing
In the second quarter of 2009, the Company’s cost of goods sold
decreased to $12.9 million or 39% of sales. For the second quarter of
2008, cost of goods sold was $17.4 million or 48% of sales which
included a $1.9 million amortization expense for the anticipated
achievement of an Oncaspar sales milestone. The improvement is also due
to efficiencies from the completion of the manufacturing consolidation.
Timing of production of the Company’s marketed products and products
manufactured for its third-party customers will cause fluctuations in
the overall cost of goods.
Research and Development
The Company’s research and development expenses were $21.2 million for
the three months ended June 30, 2009, as compared to $14.1 million for
the three months ended June 30, 2008. During the quarter, Enzon was
successful in initiating enrollment in a comprehensive Phase II study
for its PEG-SN38 compound. The increase is also due to the investments
in the next generation Oncaspar program. During the second quarter of
2009, the investment in the next-generation programs increased to $9.4
million. As noted in the Company’s 2009 R&D guidance, the Company will
continue to make significant investments in these programs to ensure
long-term supply of these critical products to its patients. Enzon is
also committed to making strategic investments in research and
development to advance its innovative oncology pipeline.
Selling, General and Administrative
Selling, general and administrative expenses decreased to $16.4 million
for the three months ended June 30, 2009, as compared to $18.1 million
for the three months ended June 30, 2008. SG&A was impacted by costs
associated with the previously considered spin-off of the biotechnology
assets in 2008 and potential consent solicitation in 2009. The decrease
is primarily due to discipline on investment in selling, marketing, and
other initiatives to support its product sales performance. The Company
is also experiencing G&A efficiencies from its recent restructuring
initiatives.
Restructuring Charge
In 2008, the Company reported $0.9 million in restructuring charges
related to severance costs from the consolidation of the manufacturing
facilities to Indianapolis, IN. As previously reported, the Company may
incur future lease termination costs associated with the manufacturing
consolidation.
Other Income (Expense)
Net other income (expense) is comprised of investment income, interest
expense, and other non-operating expenses. The Company reported net
other expense of approximately $1.5 million for the three months ended
June 30, 2009 and net other expense of $2.0 million for the three months
ended June 30, 2008. Interest expense has decreased as a result of the
reduction in the Company’s debt balance. In 2008, due to a decline in
fair market value, Enzon reduced the carrying value of its auction rate
security. This resulted in a $645 thousand impairment loss. In 2009,
interest income declined due to the reduction in cash and investments.
Cash and Investments
Total cash reserves, which include cash, cash equivalents, short-term
investments, and marketable securities, were $187.8 million as of June
30, 2009, as compared to $206.9 million as of December 31, 2008. During
the first quarter of 2009, the Company repurchased $20.4 million of its
outstanding 4% notes due in 2013 for $15.6 million. The Company also
paid a $5.0 million milestone payment related to the Company’s Oncaspar
marketing and distribution rights which was triggered in the
second-quarter of 2008. As previously guided, the Company expects to
maintain a neutral operating cash flow in 2009.
Adjusted Financial Results
For the three months ended June 30, 2009, Enzon reported an adjusted net
loss of $5.1 million or $0.11 per diluted share, as compared to an
adjusted net loss of $0.6 million or $0.01 per diluted share for the
three months ended June 30, 2008.
The following table reconciles the Company’s 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, 2009 and 2008
respectively:
|
|
|
Three Months Ended
(in thousands, except per-share amounts)
|
|
|
|
June 30, 2009
|
|
June 30, 2008
|
|
|
|
Net loss
|
|
Net loss per diluted share
|
|
Net loss
|
|
Net loss per diluted share
|
|
GAAP net loss
|
|
$
|
(5,066
|
)
|
|
$
|
(0.11
|
)
|
|
$
|
(1,745
|
)
|
|
$
|
(0.04
|
)
|
|
Adjustment to GAAP net loss:
|
|
|
|
|
|
|
|
|
|
Add: Costs related with the proposed spin-off of biotechnology
activities (1)
|
|
|
|
|
|
|
1,140
|
|
|
|
0.03
|
|
|
Adjusted net loss (2)
|
|
$
|
(5,066
|
)
|
|
$
|
(0.11
|
)
|
|
$
|
(605
|
)
|
|
$
|
(0.01
|
)
|
|
(1) Adjusted financial results for the second quarter of 2008
exclude the costs related with the Company’s previously considered
spin-off of its research and development activities.
(2) Adjusted net (loss) and adjusted net (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 (loss) and
adjusted net (loss) per share reflecting adjustments for certain
items that the Company deems to be non-recurring.
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Conference Call and Webcast
Enzon will be hosting a conference call August 4, 2009 at 9:00 am ET.
All interested parties may access the call by using the following
information:
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Domestic Dial-In Number:
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(888) 312-3051
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International Dial-In Number:
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(719) 457-2694
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Access Code:
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Enzon
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Enzon’s conference call will also be webcast in a “listen only” mode via
the Internet at http://investor.enzon.com/eventdetail.cfm?eventid=71133.
Additionally, for those parties unable to listen at the time of Enzon’s
conference call, a telephone rebroadcast will be available following the
call from August 4, 2009, at approximately 12:00 p.m. ET. This
rebroadcast will end on August 11, 2009, at approximately 12:00 p.m. ET.
The rebroadcast may be accessed using the following information:
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Domestic Dial-In Number:
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(888) 203-1112
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International Dial-In Number:
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(719) 457-0820
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Replay Passcode:
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3410491
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About Enzon
Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to
developing, manufacturing and commercializing important medicines for
patients with cancer and other life-threatening conditions. The Company
has a portfolio of four marketed products, Oncaspar®, DepoCyt®, Abelcet®
and Adagen®. Enzon’s drug development programs utilize several
cutting-edge approaches, including its industry-leading PEGylation
technology platform and the Locked Nucleic Acid (LNA) technology.
Enzon’s 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 its revenue base. Further
information about Enzon and this press release can be found on the
Company’s 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, Enzon’s 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 year ended
December 31, 2008. 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.
|
|
|
Enzon Pharmaceuticals, Inc. and Subsidiaries
Consolidated Statements of Operations
Three Months ended June 30, 2009 and 2008
(In thousands, except per-share amounts)
(Unaudited)
|
|
|
|
June 30, 2009
|
|
June 30, 2008
|
|
Revenues:
|
|
|
|
|
|
Product sales, net
|
|
$
|
29,873
|
|
|
$
|
29,206
|
|
|
Royalties
|
|
|
13,919
|
|
|
|
15,035
|
|
|
Contract manufacturing
|
|
|
3,402
|
|
|
|
6,723
|
|
|
Total revenues
|
|
|
47,194
|
|
|
|
50,964
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
Cost of product sales and contract manufacturing
|
|
|
12,860
|
|
|
|
17,406
|
|
|
Research and development
|
|
|
21,195
|
|
|
|
14,056
|
|
|
Selling, general and administrative
|
|
|
16,420
|
|
|
|
18,070
|
|
|
Amortization of acquired intangible assets
|
|
|
166
|
|
|
|
166
|
|
|
Restructuring charge
|
|
|
-
|
|
|
|
889
|
|
|
Total costs and expenses
|
|
|
50,641
|
|
|
|
50,587
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income
|
|
|
(3,447
|
)
|
|
|
377
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
Investment income, net
|
|
|
1,152
|
|
|
|
1,120
|
|
|
Interest expense
|
|
|
(2,751
|
)
|
|
|
(3,181
|
)
|
|
Other, net
|
|
|
54
|
|
|
|
24
|
|
|
|
|
|
(1,545
|
)
|
|
|
(2,037
|
)
|
|
Loss before income tax provision
|
|
|
(4,992
|
)
|
|
|
(1,660
|
)
|
|
Income tax provision
|
|
|
74
|
|
|
|
85
|
|
|
Net loss
|
|
|
($5,066
|
)
|
|
|
($1,745
|
)
|
|
|
|
|
|
|
|
Loss per common share – basic
|
|
|
($0.11
|
)
|
|
|
($0.04
|
)
|
|
Loss per common share – diluted
|
|
|
($0.11
|
)
|
|
|
($0.04
|
)
|
|
Weighted average shares – basic
|
|
|
45,187
|
|
|
|
44,352
|
|
|
Weighted average shares – diluted
|
|
|
45,187
|
|
|
|
44,352
|
|
|
|
|
Enzon Pharmaceuticals, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
June 30, 2009 and December 31, 2008
(In thousands)
(Unaudited)
|
|
|
|
June 30, 2009
|
|
December 31, 2008
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash and short-term investments
|
|
$
|
116,927
|
|
$
|
144,184
|
|
Accounts receivable, net
|
|
|
17,646
|
|
|
11,692
|
|
Inventories
|
|
|
17,591
|
|
|
16,268
|
|
Other current assets
|
|
|
7,234
|
|
|
5,281
|
|
Total current assets
|
|
|
159,398
|
|
|
177,425
|
|
Property and equipment, net
|
|
|
42,053
|
|
|
44,585
|
|
|
|
|
|
|
|
Other assets:
|
|
|
|
|
|
Marketable securities
|
|
|
70,875
|
|
|
62,678
|
|
Amortizable intangible assets, net
|
|
|
55,227
|
|
|
60,654
|
|
Other assets
|
|
|
3,541
|
|
|
3,911
|
|
|
|
|
129,643
|
|
|
127,243
|
|
Total assets
|
|
$
|
331,094
|
|
$
|
349,253
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
26,906
|
|
$
|
33,144
|
|
Notes payable
|
|
|
-
|
|
|
2,950
|
|
Total current liabilities
|
|
|
26,906
|
|
|
36,094
|
|
|
|
|
|
|
|
Notes payable
|
|
|
250,050
|
|
|
267,550
|
|
Other liabilities
|
|
|
4,261
|
|
|
3,948
|
|
Total liabilities
|
|
|
281,217
|
|
|
307,592
|
|
|
|
|
|
|
|
Stockholders’ equity
|
|
|
49,877
|
|
|
41,661
|
|
Total liabilities and stockholders’ equity
|
|
$
|
331,094
|
|
$
|
349,253
|
|
|
|
|
|
|
|
Common shares outstanding
|
|
|
45,351
|
|
|
45,032
|
Enzon Pharmaceuticals, Inc.
Craig Tooman, 908-541-8777
EVP,
Finance and Chief Financial Officer