[CYTOGEN LOGO]
COMPANY CONTACT:
Cytogen Corporation
Stacy Shearer
Investor Relations
(609) 750-8289
sshearer@cytogen.com
CYTOGEN REPORTS RECORD PRODUCT REVENUES IN THE FIRST QUARTER OF 2004 AND
REAFFIRMS 2004 FULL YEAR FINANCIAL GUIDANCE
Year-over-year growth from both QUADRAMET(TM) and PROSTASCINT(R) drives record
product revenues for the quarter
PRINCETON, N.J., (MAY 4, 2004) -- Cytogen Corporation (Nasdaq: CYTO), a
product-driven, oncology-focused biopharmaceutical company, today reported its
consolidated financial results for the first quarter ended March 31, 2004.
Total revenues for the first quarter of 2004 were $3.6 million compared to $2.5
million in the first quarter of 2003, with product revenues increasing to a
record $3.6 million from $1.9 million in the first quarter of 2003. Cytogen
reported a net loss of $4.3 million or $0.33 per basic and diluted share for the
first quarter of 2004 compared to a net loss of $2.0 million or $0.22 per basic
and diluted share for the same period in 2003.
"We continue to aggressively pursue expanded use and new clinical applications
for both QUADRAMET(TM) and PROSTASCINT(R), and are proud of the growth exhibited
from these products over the prior year's first quarter," said Michael D.
Becker, Cytogen's President and Chief Executive Officer. "We are also adding
resources to enhance our sales and marketing infrastructure as evidenced by a
greater than 50% increase in oncology field representatives since the August
2003 reacquisition of North and Latin America marketing rights to QUADRAMET and
the recent addition of Tom Lytle as Senior Vice President of Sales and Marketing
to oversee strategic sales and marketing initiatives for both existing and
future oncology products, such as COMBIDEX(R). Finally, to further support all
of these activities, we recently raised approximately $24 million in capital
from recognized institutional investors."
Product Revenue
QUADRAMET
Sales of QUADRAMET (samarium Sm-153 lexidronam injection), a unique skeletal
targeting therapeutic radiopharmaceutical for the relief of pain due to bone
metastases arising from prostate, breast, multiple myeloma and other types of
cancer, were $1.9 million for the first quarter of 2004.
Under a 1998 agreement, Berlex Laboratories had marketing rights for QUADRAMET
in North and Latin America. Through July 31, 2003, Cytogen received and reported
royalties on product sales made by Berlex. Such royalty revenue from sales of
QUADRAMET during the first quarter of 2003 was $449,000.
On August 1, 2003, Cytogen reacquired these marketing rights from Berlex in
exchange for an upfront cash payment of $8.0 million and royalties based on
future sales of QUADRAMET. At that time, Cytogen began recording product revenue
from the sales of QUADRAMET.
QUADRAMET REVENUE SUMMARY
($ in millions)
2003 2003 2003 2003 2004
Q1 Q2 Q3 Q4 Q1
Product Sales n/a n/a $1.2 $1.6 $1.9
Royalties $0.4 $0.5 $0.2 n/a n/a
---- ---- ---- ---- ----
TOTAL: $0.4 $0.5 $1.4 $1.6 $1.9
PROSTASCINT
Sales of PROSTASCINT (capromab pendetide), the first and only commercial
monoclonal antibody-based molecular imaging agent targeting prostate-specific
membrane antigen, or PSMA, were $1.7 million in the first quarter of 2004
compared to $1.6 million in the first quarter of 2003.
During 2003, Cytogen collected and presented data to the Centers for Medicare &
Medicaid Services (CMS) demonstrating the need for change in the relative value
of PROSTASCINT for the hospital outpatient prospective payment system (HOPPS). A
more appropriate higher PROSTASCINT reimbursement value was established for 2004
that the Company believes will help ensure that hospitals are not discouraged
from providing Medicare beneficiaries access to this important and clinically
useful molecular imaging procedure.
PROSTASCINT REVENUE SUMMARY
($ in millions)
2003 2003 2003 2003 2004
Q1 Q2 Q3 Q4 Q1
Product Sales $1.6 $1.6 $1.5 $1.8 $1.7
Other product revenues
Other product revenues, consisting of brachytherapy products and NMP22(R)
BLADDERCHEK(R) (nuclear matrix protein-22), a point-of-care, in vitro diagnostic
test for bladder cancer developed by Matritech, Inc., were not significant in
the first quarter of 2004 compared to $265,000 in the first quarter of 2003. As
previously announced, Cytogen discontinued marketing brachytherapy products
effective January 24, 2003. From November 2002 through December 31, 2003,
Cytogen promoted NMP22 BLADDERCHEK primarily to urologists in the United States.
After December 31, 2003, Cytogen has been selling NMP22 BLADDERCHEK exclusively
to oncologists.
Costs and Expenses
Total operating expenses in the first quarter of 2004 were $7.9 million compared
to $5.0 million in the first quarter of 2003. Operating expenses in 2004
reflect, among other items, QUADRAMET and PROSTASCINT manufacturing costs,
royalties paid by Cytogen to Dow Chemical and Berlex Laboratories on our sales
of QUADRAMET, and the amortization of the up-front payment to Berlex to
reacquire QUADRAMET. The 2004 operating expenses also include increased selling
and marketing expenses related to the expansion of the Company's sales force and
marketing initiatives for the Company's existing oncology products. The 2004 and
2003 operating expenses also reflect costs associated with the PSMA Development
Company LLC ("PDC"), a joint venture between Cytogen and Progenics
Pharmaceuticals, Inc., for the development of in vivo immunotherapies targeting
prostate specific membrane antigen (PSMA). Cytogen's share of the equity in the
loss associated with PDC was $809,000 for the first quarter of 2004 compared to
$880,000 in the first quarter of 2003.
Cash Position
Cytogen's cash, cash equivalents and short-term investments balance as of March
31, 2004 was $25.0 million compared to $30.2 million as of December 31, 2003. In
April 2004, the Company received net proceeds of approximately $24.0 million in
connection with a registered direct offering of 2,570,000 shares of its common
stock.
Clinical Development Update
QUADRAMET is currently being evaluated alone, at higher doses, and in a series
of combination therapy regimens in order to assess potential synergies with
anti-tumor drugs, such as docetaxel, and other bone seeking agents, such as
zoledronic acid, based on demonstrated clinical activity in hormone-refractory
prostate cancer, multiple myeloma, osteosarcoma and other cancers. In addition
to pain palliation, analyses of data from these investigational monotherapy and
combination therapy studies demonstrate that QUADRAMET may have a broader role
as an oncolytic agent in a variety of solid tumor and hematological
malignancies, including acute lymphoblastic leukemia, acute myeloid leukemia,
and myelodysplastic syndrome. New clinical studies are expected to begin
throughout 2004 with a goal to identify the most promising QUADRAMET programs to
advance. Data from several investigational studies has been accepted for
dissemination at the upcoming American Society of Clinical Oncology (ASCO)
Annual Meeting and additional publications and presentations are expected during
2004.
Year-to-date 2004 Highlights
- - Thomas S. Lytle joined Cytogen as Senior Vice President of Sales and
Marketing. Mr. Lytle will oversee strategic sales and marketing initiatives
for Cytogen's existing and future oncology products.
- - The Company received net proceeds of approximately $24.0 million in
connection with a registered direct offering of 2,570,000 shares of its
common stock.
- - Clinical data demonstrating that overexpression of Prostate-Specific
Membrane Antigen (PSMA) in primary prostate cancer not only correlates with
other adverse traditional prognostic factors, but independently predicts
disease recurrence was published in the journal Clinical Cancer Research
(Volume 9, No. 17, pp. 6357-6362). Overexpression of PSMA in this study was
determined by immunohistochemical staining using the same monoclonal
antibody utilized in PROSTASCINT.
- - Data derived from Cytogen's proprietary protein interaction technology was
published in the journal Proteomics (Volume 4, No. 3, pp. 643-655) and
positive results from a research collaboration between Cytogen and the
Kimmel Cancer Institute at Thomas Jefferson University designed to identify
novel interactions associated with Wwox, a tumor suppressor protein, was
published in the Proceedings of the National Academy of Sciences of the
United States (Volume 101, No. 13, pp. 4401-4406).
Financial Outlook for 2004
The Company reaffirms its previous issued financial guidance as follows:
- -- Reflecting only QUADRAMET and PROSTASCINT, Cytogen expects an increase in
2004 full year product revenue of approximately 65% to 75% over its 2003 product
revenue of $9.8 million;
- -- In 2004, Cytogen expects an average gross margin of approximately 40%, which
reflects QUADRAMET and PROSTASCINT manufacturing costs and royalties to Dow
Chemical and Berlex Laboratories;
- -- In 2004, Cytogen expects an increase in its full year total selling, general
and administrative expenses of approximately 55 to 60% compared to the $11.6
million incurred in these areas in 2003 due primarily to sales force expansion
and other marketing initiatives associated with the commercialization of the
Company's existing and anticipated oncology products;
- -- Cytogen expects an increase in 2004 full year research and development
expenses of approximately 55% to 60% over its 2003 research and development
expenses of $2.7 million due primarily to investigational studies relating to
QUADRAMET; and
- -- In 2004, Cytogen expects an increase in its share of the equity loss
associated with the PDC joint venture of approximately 30% over its 2003 share
of the equity loss of $3.5 million due primarily to third party manufacturing
and development costs related to PDC's monoclonal antibody programs in
preparation for initiation of human clinical trials.
The statements made in the foregoing paragraphs under the heading "Financial
Outlook for 2004" are forward-looking statements, subject to the disclosure
notice paragraph regarding forward-looking statements set forth below.
NOTE:
QUADRAMET is indicated for the relief of pain in patients with confirmed
osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.
This press release describes clinical applications that differ from that
reported in the QUADRAMET package insert.
PROSTASCINT is indicated as a diagnostic imaging agent in newly diagnosed
patients with biopsy-proven prostate cancer, thought to be clinically localized
after standard diagnostic evaluation and who are thought to be at high risk for
pelvic lymph node metastases. PROSTASCINT is also indicated as a diagnostic
imaging agent in post-prostatectomy patients with a rising PSA and a negative or
equivocal standard metastatic evaluation in whom there is a high clinical
suspicion of occult metastatic disease. This press release describes clinical
applications and imaging performance that differs from that reported in the
PROSTASCINT package insert.
A copy of the full prescribing information for QUADRAMET, PROSTASCINT, and NMP22
BLADDERCHEK may be obtained in the U.S. from Cytogen Corporation by calling toll
free 800-833-3533 or by visiting the web site at http://www.cytogen.com, which
is not part of this press release.
About Cytogen Corporation
Founded in 1980, Cytogen Corporation of Princeton, NJ is a product-driven,
oncology-focused biopharmaceutical company that develops and commercializes a
balanced portfolio of oncology products that address the unmet medical needs of
patients and the physicians that serve them. Cytogen directly markets
QUADRAMET(TM) (samarium Sm-153 lexidronam injection), PROSTASCINT(R) (capromab
pendetide) kit for the preparation of Indium In-111 capromab pendetide, and
NMP22(R) BLADDERCHEK(R) (nuclear matrix protein-22) in the United States.
Cytogen has exclusive United States marketing rights to COMBIDEX(R)
(ferumoxtran-10), an investigational molecular imaging agent consisting of
lymphotropic superparamagnetic nanoparticles used in conjunction with magnetic
resonance imaging to aid in the diagnosis of metastatic lymph nodes, which is
under review by the U.S. Food and Drug Administration. Cytogen is also
developing therapeutics targeting prostate-specific membrane antigen (PSMA), a
protein highly expressed on the surface of prostate cancer cells and the
neovasculature of solid tumors. Full prescribing information for the Company's
products is available at www.cytogen.com or by calling 1-800-833-3533. For more
information, please visit the Company's website at www.cytogen.com, which is not
part of this press release.
This press release contains certain "forward-looking" statements within the
meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E
of the Securities Exchange Act of 1934, as amended. All statements, other than
statements of historical facts, included in this press release regarding our
strategy, future operations, financial position, future revenues, projected
costs, prospects, plans and objectives of management are forward-looking
statements. Such forward-looking statements involve a number of risks and
uncertainties and investors are cautioned not to put any undue reliance on any
forward-looking statement. There are a number of important factors that could
cause Cytogen's results to differ materially from those indicated by such
forward-looking statements. In particular, Cytogen's business is subject to a
number of significant risks, which include, but are not limited to: the risk of
obtaining the necessary regulatory approvals; the risk of whether products
result from development activities; the risk of shifts in the regulatory
environment affecting sales of Cytogen's products such as third-party payor
reimbursement issues; the risk associated with Cytogen's dependence on its
partners for development of certain projects, as well as other factors expressed
from time to time in Cytogen's periodic filings with the Securities and Exchange
Commission (the "SEC"). As a result, this press release should be read in
conjunction with Cytogen's periodic filings with the SEC. The forward-looking
statements contained herein are made only as of the date of this press release,
and Cytogen undertakes no obligation to publicly update such forward-looking
statements to reflect subsequent events or circumstances.
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CYTOGEN CORPORATION & SUBSIDIARIES
(All amounts in thousands except per share data)
(Unaudited)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED
MARCH 31,
--------------------------
2004 2003
--------- ---------
Revenues:
Quadramet $ 1,854 $ -
ProstaScint 1,727 1,620
Other 1 265
-------- --------
Total Product Revenue 3,582 1,885
-------- --------
Royalty Revenue - 449
License and Contract Revenue 19 143
-------- --------
Total Revenues 3,601 2,477
-------- --------
Operating Expenses:
Cost of Product Related Revenue 2,399 910
Selling, General and Administrative 3,755 2,378
Research and Development 940 833
Equity in Loss of Joint Venture 809 880
-------- --------
Total Operating Expenses 7,903 5,001
-------- --------
Interest Income (Expense), Net 20 (11)
Income Tax Benefit - (584)
-------- --------
Net Loss $ (4,282) $ (1,951)
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Basic and Diluted Net Loss Per Share $ (0.33) $ (0.22)
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Weighted Average Common Shares Outstanding 12,860 8,763
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CONDENSED CONSOLIDATED BALANCE SHEETS
MARCH 31, DECEMBER 31,
2004 2003
---------- ------------
Assets:
Cash, Cash Equivalents and Short-Term Investments $24,986 $30,215
Accounts Receivable, Net 1,257 1,445
Inventories 1,575 1,887
Property and Equipment, Net 648 595
Quadramet License Fee, Net 7,546 7,720
Other Assets 2,227 1,833
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Total Assets $38,239 $43,695
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Liabilities and Stockholders' Equity:
Accounts Payable and Accrued Liabilities $ 3,901 $ 5,125
Other Current Liabilities 75 76
Long-Term Liabilities 2,485 2,454
Stockholders' Equity 31,778 36,040
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Total Liabilities and Stockholders' Equity $38,239 $43,695
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