EXHIBIT 99.1
[CYTOGEN LOGO]
COMPANY CONTACT:
Cytogen Corporation
Stacy Shearer
Investor Relations
(609) 750-8289
sshearer@cytogen.com
CYTOGEN REPORTS RECORD PRODUCT REVENUES IN THE SECOND QUARTER OF 2004
Company Reaffirms 2004 Full Year Financial Guidance
PRINCETON, N.J., (AUGUST 5, 2004) -- Cytogen Corporation (Nasdaq: CYTO), a
product-driven, oncology-focused biopharmaceutical company, today reported its
consolidated financial results for the second quarter and six months ended June
30, 2004 and reaffirmed its 2004 full year financial guidance.
Second quarter sales were strong with total product revenues of $3.9 million for
the quarter ended June 30, 2004 compared to $1.7 million for the same period in
2003. For the six months ended June 30, 2004, product revenues were $7.5 million
compared to $3.6 million for the same period in 2003.
Cytogen reported a net loss of $4.4 million, or $0.30 per basic and diluted
share, for the quarter ended June 30, 2004 compared to a net loss of $3.4
million, or $0.37 per basic and diluted share, for the same period in 2003. For
the six months ended June 30, 2004, Cytogen reported a net loss of $8.7 million,
or $0.63 per basic and diluted share, compared to $5.3 million, or $0.60 per
basic and diluted share, for the same period in 2003.
"We are very pleased to report another quarter of significant progress at
Cytogen," said Michael D. Becker, Cytogen's President and Chief Executive
Officer. "First, we are encouraged by the year-over-year increase in
PROSTASCINT(R) sales that we believe principally resulted from a combination of
increased demand and changes in distributor buying patterns. Second, the recent
publication and presentation of new clinical data re-affirming the benefits of
QUADRAMET(TM), along with favorable feedback from continued market research,
confirms our expectations for increases in QUADRAMET sales during the second
half of the year. We believe that key physicians share our excitement for
QUADRAMET in that they have expressed interest in incorporating its use into
their practice, participating in our new product evaluation programs, and
initiating clinical studies to enhance both the current and future utility of
this product. Finally, we are encouraged by the recent submission of a response
to the approvable letter received from the U.S. Food and Drug Administration
(FDA) for COMBIDEX(R) by Advanced Magnetics, Inc. and our efforts are now
focused on appropriate pre-launch preparation and related activities."
PRODUCT REVENUE
- ---------------
QUADRAMET
Sales of QUADRAMET (samarium Sm-153 lexidronam injection), a long-acting,
non-opioid treatment for the relief of pain due to bone metastases arising from
prostate, breast, multiple myeloma and other types of cancer, were $1.6 million
for the quarter ended June 30, 2004. For the six months ended June 30, 2004,
QUADRAMET sales were $3.5 million.
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 quarter and six months ended June 30, 2003 was $465,000 and
$914,000, respectively.
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 2004
Q1 Q2 Q3 Q4 | Q1 Q2
---- ---- ---- ---- | ---- ----
Product Sales n/a n/a $1.2 $1.6 | $1.9 $1.6
Royalties $0.4 $0.5 $0.2 n/a | n/a n/a
---- ---- ---- ---- | ---- ----
|
TOTAL: $0.4 $0.5 $1.4 $1.6 | $1.9 $1.6
PROSTASCINT
Sales of PROSTASCINT (capromab pendetide), the first commercial monoclonal
antibody-based molecular imaging agent targeting prostate-specific membrane
antigen, or PSMA, used to image the extent and spread of prostate cancer were
$2.3 million for the quarter ended June 30, 2004 compared to $1.6 million for
the same period in 2003. For the six months ended June 30, 2004, PROSTASCINT
sales were $4.0 million compared to $3.2 million for the same period in 2003.
As previously communicated, during 2003 Cytogen collected and presented data to
the Centers for Medicare & Medicaid Services (CMS) demonstrating the need for
change in the relative value of PROSTASCINT for the hospital outpatient
prospective payment system (HOPPS). For 2004, a more appropriate higher
PROSTASCINT reimbursement value was established that the Company believes will
help ensure that hospitals are not discouraged from providing Medicare
beneficiaries access to this important and clinically useful molecular imaging
procedure.
PROSTASCINT REVENUE SUMMARY
($ in millions)
2003 2003 2003 2003 | 2004 2004
Q1 Q2 Q3 Q4 | Q1 Q2
---- ---- ---- ---- | ---- ----
Product Sales $1.6 $1.6 $1.5 $1.8 | $1.7 $2.3
OTHER PRODUCT REVENUE
- ---------------------
Other product revenue, consisting of both 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 or second quarters of 2004 compared to $265,000 and $98,000 in the
first and second quarters of 2003, respectively. 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 for the quarter ended June 30, 2004 were $8.4 million
compared to $5.7 million for the same period in 2003. For the six month period
ended June 30, 2004, operating expenses were $16.3 million compared to $10.7
million for the six month period ended June 30, 2003. Operating expenses in 2004
primarily reflect, 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 $542,000 for the second quarter of 2004 compared to
$1.1 million in the second quarter of 2003. For the six months ended June 30,
2004, Cytogen's share of the equity in the loss of PDC was $1.4 million compared
to $2.0 million in the same period of 2003.
CASH POSITION
- -------------
Cytogen's cash, cash equivalents and short-term investments balance as of June
30, 2004 was $44.8 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
- ---------------------------
Though indicated for pain palliation, preliminary clinical data suggests that
QUADRAMET may have direct anticancer activity. Accordingly, 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 and osteosarcoma. Pending approval by relevant internal review
boards, several new clinical studies are expected to begin in mid-to-late 2004.
YEAR-TO-DATE 2004 HIGHLIGHTS
- ----------------------------
- Thomas S. Lytle joined Cytogen as Senior Vice President of Sales and
Marketing to oversee strategic sales and marketing initiatives for
Cytogen's existing and future oncology products.
- Cytogen 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 correlates with
other adverse traditional prognostic factors and independently
predicts disease recurrence was reported in the medical journal
Clinical Cancer Research ("Correlation of Primary Tumor
Prostate-Specific Membrane Antigen Expression with Disease Recurrence
in Prostate Cancer," Clinical Cancer Research, Volume 9, No. 17, pp.
6357-6362).
- Positive results from the collaboration between Cytogen and
researchers at the Kimmel Cancer Institute at Thomas Jefferson
University designed to identify novel interactions associated with
Wwox, a tumor suppressor protein, were published in the Proceedings of
the National Academy of Sciences (PNAS) ("Functional association
between Wwox tumor suppressor protein and p73, a p53 homolog," PNAS,
Volume 101, No. 13, pp. 4401-4406).
- A prospective, randomized, double-blind multi-center study
demonstrating that QUADRAMET both provides significant pain relief
from bone metastases secondary to prostate cancer and enables patients
to significantly decrease their use of opioid analgesics was reported
in the May 2004 issue of the peer-reviewed medical journal Urology
("Samarium-153- Lexidronam Complex for Treatment of Painful Bone
Metastases in Hormone- Refractory Prostate Cancer," Urology, Volume
63, No. 5, pp. 940-945).
- The findings of three separate studies relating to QUADRAMET were
presented at the 40th Annual Meeting of the American Society of
Clinical Oncology (ASCO). The studies demonstrated the use of
QUADRAMET in conjunction with other therapies for the treatment of
bone metastases secondary to prostate cancer, breast cancer, and
multiple myeloma.
- Cytogen was added to the Russell 3000(R) Index when the broad-market
index was reconstituted on June 25, 2004.
- Advances in prostate cancer imaging using PROSTASCINT were presented
at the 51st Annual Meeting of the Society of Nuclear Medicine.
- Advanced Magnetics, Inc. and Cytogen Corporation announced that
Advanced Magnetics submitted a response to the approvable letter
received from the U.S. Food and Drug Administration (FDA) for
COMBIDEX, an investigational molecular imaging agent to aid in the
non-invasive diagnosis of metastatic lymph nodes.
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.
CONFERENCE CALL & WEBCAST INFORMATION
- -------------------------------------
Cytogen will broadcast its quarterly investor conference call live over the
Internet today, Thursday, August 5, 2004 at 9:00 a.m. Eastern Time. The dial-in
number for the U.S. is 800-901-5213 and the dial-in number for international
callers is 617-786-2962. The pass code number is 17064226. This event can also
be accessed by going to Cytogen's Web site, www.cytogen.com, and clicking on
Investor Relations. A link to the webcast is under the Calendar of Events
header. The event will be archived and available for replay starting
approximately one hour after the call and continuing for 7 days thereafter. A
replay of the conference call will be available for seven days following the
call. The replay dial-in number for the U.S. is 888-286-8010 and the dial-in
number for international callers is 617-801-6888. The replay pass code number is
39220111.
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 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 iron
oxide nanoparticles for use in conjunction with magnetic resonance imaging to
aid in the differentiation of cancerous and non-cancerous 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.
###
CYTOGEN CORPORATION & SUBSIDIARIES
(All amounts in thousands except per share data)
(Unaudited)
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30, JUNE 30,
-------------------- --------------------
2004 2003 2004 2003
-------- -------- -------- --------
Revenues:
Quadramet $ 1,616 $ - $ 3,470 $ -
ProstaScint 2,312 1,599 4,039 3,219
Others - 98 1 363
-------- -------- -------- --------
Total Product Revenue 3,928 1,697 7,510 3,582
Royalty Revenue - 465 - 914
License and Contract Revenue 24 164 43 307
-------- -------- -------- --------
Total Revenues 3,952 2,326 7,553 4,803
-------- -------- -------- --------
Operating Expenses:
Cost of Product Related Revenue 2,396 900 4,795 1,810
Selling, General and Administrative 4,914 2,967 8,805 5,366
Research and Development 541 718 1,345 1,530
Equity in Loss of Joint Venture 542 1,086 1,351 1,966
-------- -------- -------- --------
Total Operating Expenses 8,393 5,671 16,296 10,672
-------- -------- -------- --------
Interest Income (Expense), Net 57 (23) 77 (34)
Income Tax Benefit - - - (584)
-------- -------- -------- --------
Net Loss $ (4,384) $ (3,368) $ (8,666) $ (5,319)
======== ======== ======== ========
Basic and Diluted Net Loss Per Share $ (0.30) $ (0.37) $ (0.63) $ (0.60)
======== ======== ======== ========
Weighted Average Common Shares Outstanding 14,848 9,051 13,859 8,909
======== ======== ======== ========
CONDENSED CONSOLIDATED BALANCE SHEETS
JUNE 30, DECECEMBER 31,
2004 2003
----------- --------------
Assets:
Cash, Cash Equivalents and Short-Term Investments $ 44,840 $ 30,215
Accounts Receivable, Net 1,946 1,445
Inventories 1,432 1,887
Property and Equipment, Net 747 595
Quadramet License Fee, Net 7,372 7,720
Other Assets 1,586 1,833
--------- ---------
Total Assets $ 57,923 $ 43,695
========= =========
Liabilities and Stockholders' Equity:
Accounts Payable and Accrued Liabilities $ 4,002 $ 5,125
Other Current Liabilities 58 76
Long-Term Liabilities 2,457 2,454
Stockholders' Equity 51,406 36,040
--------- ---------
Total Liabilities and Stockholders' Equity $ 57,923 $ 43,695
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