EXHIBIT 99.1
[CYTOGEN LOGO]
COMPANY CONTACT:
Cytogen Corporation
Stacy Shearer
Investor Relations
(609) 750-8289
sshearer@cytogen.com
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CYTOGEN REPORTS SECOND QUARTER 2003 FINANCIAL RESULTS
MARKETING ALLIANCES, REACQUISITION OF MARKETING RIGHTS TO QUADRAMET(R),
AND ANTICIPATED INTRODUCTION OF COMBIDEX(R) EXPECTED TO DRIVE FUTURE SALES
PRINCETON, N.J., (AUGUST 14, 2003) -- Cytogen Corporation (Nasdaq: CYTO), a
product-driven, oncology-focused biopharmaceutical company, today reported its
consolidated financial results for the three and six month periods ended June
30, 2003.
Total revenues were $2.33 million for the second quarter of 2003 compared to
$3.17 million for the second quarter of 2002. For the six month period ended
June 30, 2003, total revenues were $4.80 million compared to $6.46 million for
the six month period ended June 30, 2002. The decline in revenue was driven, in
part, by the previously announced discontinuation of brachytherapy products
since January 24, 2003, and OncoScint(R) (Satumomab pendetide) since December
31, 2002. There were no revenues from such discontinued products for the second
quarter of 2003 compared to $621,000 for the second quarter of 2002. For the six
month period ended June 30, 2003, total revenues from such discontinued products
were $240,000 compared to $1.13 million for the six month period ended June 30,
2002. These declines were partially offset by increased sales of NMP22(R)
BladderChek(TM), which Cytogen began introducing to urologists in the United
States in November 2002, along with increased license and contract revenues.
Net loss for the second quarter of 2003 was $3.37 million or $0.37 per share
compared to a net loss of $3.21 million or $0.39 per share for the second
quarter of 2002. Net loss for the six month period ended June 30, 2003 was $5.32
million or $0.60 per share compared to a net loss of $8.21 million or $1.00 per
share for the six month period ended June 30, 2002. The net loss for the six
month period ended June 30, 2002 included a non-cash milestone expense of $2.0
million related to the progress of ex vivo dendritic cell prostate cancer
clinical trials at Northwest Biotherapeutics, Inc.
"During the first half of 2003 we laid a solid foundation for future growth by
reducing operating expenses, enhancing and strengthening ProstaScint(R) through
marketing alliances, and reacquiring marketing rights to Quadramet(R) - our lead
therapeutic product," said Michael D. Becker, President and Chief Executive
Officer of Cytogen Corporation. "In view of recently reported and ongoing
clinical studies suggesting that certain unique properties of Quadramet may
allow it to be used in combination with other drugs, such as chemotherapeutics
and bisphosphonates, to treat a variety of cancers, we believe that the addition
of Quadramet to our marketed product portfolio has great significance for
Cytogen's future growth. We intend to continue to aggressively pursue these
investigational applications."
Product Sales and Performance
Sales of ProstaScint (Capromab pendetide), Cytogen's first monoclonal
antibody-based product targeting prostate specific membrane antigen, or PSMA,
were $1.60 million in the second quarter of 2003 compared to $1.97 million in
the second quarter of 2002. For the six month period ended June 30, 2003, sales
of ProstaScint were $3.22 million compared to $4.05 million for the six month
period ended June 30, 2002.
Future potential growth for ProstaScint is largely dependent upon, among other
things, the implementation and continued research of the following:
- Advances in imaging technology
- Fusion imaging - an image processing technique that combines
functional information from a ProstaScint scan with anatomic
images provided by CT (computed tomography) or MR (magnetic
resonance) scans in a digital overlay to provide information that
cannot be achieved with separate imaging modalities alone, which
may improve diagnostic interpretation; and
- Image enhancements - improving the quality of ProstaScint images
through reconstruction and attenuation-correction methods to
address inherent limitations of single photon emission computed
tomography (SPECT) imaging by correcting for the effects of
radiation scatter and/or inherent collimator and detector blur.
- New product applications
- Utilization of ProstaScint scans to guide therapy ("image-guided
therapy"), to enhance therapy targeting for treatments such as
brachytherapy, cryotherapy and external beam radiation, such as
intensity modulated radiation therapy (IMRT); and
- Utilization of ProstaScint scans to guide biopsy ("image-guided
biopsy"), which could be facilitated by future advances in image
acquisition technology.
Royalty revenue from the sale of Quadramet (Samarium Sm-153 lexidronam
injection) in the second quarter of 2003 was $465,000 compared to $510,000
reported in the second quarter of 2002. For the six month period ended June 30,
2003, royalty revenue from the sale of Quadramet was $914,000 compared to $1.01
million for the six month period ended June 30, 2002. Quadramet is a skeletal
targeting therapeutic radiopharmaceutical developed by Cytogen Corporation based
on technology licensed from Dow Chemical and was marketed by Berlex
Laboratories, the U.S. affiliate of Schering AG Germany, through July 31, 2003
in the United States for the relief of pain due to bone metastases arising from
prostate, breast, multiple myeloma and other types of cancer.
On August 1, 2003, Cytogen completed the previously announced reacquisition of
marketing rights held by Berlex Laboratories to Quadramet in North and Latin
America in exchange for an upfront payment of $8 million and royalties based on
future sales. Under a 1998 agreement, Berlex had marketing rights to Quadramet
in North and Latin America and Cytogen previously received and reported
royalties on product sales made by Berlex. In 2002, Berlex recorded Quadramet
sales of approximately $7.36 million, for which Cytogen recorded $1.84 million
in royalty revenue. Effective August 1, 2003, Cytogen began recording all
revenue from the sale of Quadramet. Schering AG, which acquired CIS Bio
International in 2000, will continue to market Quadramet in Europe as a direct
licensee of Dow.
Cytogen believes that future growth and market penetration of Quadramet is
largely dependent upon, among other things:
- New clinical data supporting the expanded and earlier use of Quadramet
in various cancers;
- Novel research supporting combination uses with other therapies, such
as chemotherapy and bisphophonates;
- Establishing the use of Quadramet at higher doses to target and treat
primary bone cancers; and
- Increased marketing and sales penetration to physicians.
Sales of NMP22 BladderChek (Nuclear matrix protein-22), a point-of-care, in
vitro diagnostic test for bladder cancer, were $98,000 in the second quarter of
2003 compared to $25,000 in the first quarter of 2003. For the six month period
ended June 30, 2003, NMP22 BladderChek revenue was $123,000. In October 2002,
Cytogen entered into a five-year agreement with Matritech, Inc. to be the sole
distributor of Matritech's NMP22 BladderChek device to urologists and
oncologists in the United States. During November 2002, Cytogen began promoting
NMP22 BladderChek to urologists in the United States using its in-house
specialty sales force.
Effective January 24, 2003, Cytogen discontinued selling and marketing
brachytherapy products. There were no brachytherapy product sales in the second
quarter of 2003 compared to $565,000 for the second quarter of 2002. For the six
month period ended June 30, 2003, brachytherapy product sales were $240,000
compared to $1.02 million for the six month period ended June 30, 2002.
"With regard to additional future potential growth drivers, we remain cautiously
optimistic for approval of Combidex(R), a novel lymph node imaging agent
developed by Advanced Magnetics, Inc., which we intend to market pending
clearance by the U.S. Food and Drug Administration. Our optimism about Combidex
was reinforced by the publication in June 2003 of a study in the New England
Journal Of Medicine showing that Combidex aids in the non-invasive diagnosis of
otherwise undetectable metastatic prostate cancer. We believe that Cytogen's
proprietary and licensed products - ProstaScint, Quadramet and NMP22
BladderChek; as well as late-stage opportunities, such as Combidex; and our
evolving development pipeline of in vivo immunotherapeutic products based on
prostate specific membrane antigen (PSMA), collectively represent a tremendous
opportunity for future growth," Mr. Becker concluded.
Costs and Expenses
Operating expenses in the second quarter of 2003 were $5.67 million compared to
$6.40 million in the second quarter of 2002. For the six month period ended June
30, 2003, operating expenses were $10.67 million compared to $14.73 million for
the six month period ended June 30, 2002. Operating expenses in first quarter of
2002 included a $2.0 million non-cash milestone expense related to the progress
of an ex vivo dendritic cell prostate cancer therapy, which has since been
discontinued. Operating expenses include, among other items, costs associated
with the PSMA Development Company LLC, a joint venture between Cytogen
Corporation and Progenics Pharmaceuticals, Inc. for the development of in vivo
immunotherapies utilizing prostate specific membrane antigen, or PSMA. Cytogen's
share of development costs associated with the PSMA Development Company LLC were
$1.09 million for the second quarter of 2003 compared to $595,000 in the second
quarter of 2002. Operating expenses also include research in cellular signaling
through our AxCell Biosciences subsidiary, which were $357,000 in the second
quarter of 2003 compared to $1.04 million for the second quarter of 2002.
Cash Position
Cytogen's cash and cash equivalents as of June 30, 2003 were $13.53 million
compared to $14.73 million as of December 31, 2002. During the second quarter
2003, the Company received total gross proceeds of approximately $5.0 million in
connection with a private placement of 1,052,632 shares of Cytogen common stock.
In July 2003, the Company received total gross proceeds of approximately $10.0
million in connection with a private placement of 1,172,332 shares of Cytogen
common stock, $8 million of which was used to reacquire the North and Latin
American marketing rights for Quadramet, with the balance expected to be used
for expenses related to the reacquisition. Investors in both transactions also
received warrants to purchase additional shares of Cytogen common stock. The
financial impact of the Company's July 2003 financing, reacquisition of
Quadramet, and related payment are not reflected in the financial statements
released for the period ended June 30, 2003.
Marketed and Pipeline Product Events in the Second Quarter of 2003
- Clinical investigators from cancer research centers around the world
presented new clinical data regarding the use of Quadramet in
hematological and solid tumor cancers at the Annual Meeting of the
American Society of Clinical Oncology (ASCO) from May 31, 2003 through
June 3, 2003 in Chicago, IL. Investigators presented preliminary
clinical data at ASCO demonstrating the synergies of Quadramet in
combination with a chemotherapeutic (docetaxel) for the treatment of
advanced androgen independent prostate cancer, pain palliation in
multiple myeloma in combination with a bisphosphonate (zoledronic
acid), and pain palliation resulting in a reduction of opioid usage in
solid tumor cancers.
- In mid-June, Cytogen and Berlex Laboratories, a U.S. affiliate of
Schering AG, Germany announced an agreement whereby marketing rights
held by Berlex to market Quadramet in North and Latin America would be
returned to Cytogen in exchange for an upfront payment of $8 million
and royalties based on future sales. This transaction was completed on
August 1, 2003.
- Also in mid-June, Cytogen and Advanced Magnetics, Inc. announced the
publication of clinical data in the New England Journal Of Medicine
showing that magnetic resonance (MR) imaging with Combidex aids in the
non-invasive evaluation of lymph nodes in patients with prostate
cancer. Researchers, led by Mukesh Harisinghani, MD, assistant
radiologist at Massachusetts General Hospital (MGH) and Jelle
Barentsz, MD, Professor of Radiology at the University Medical Center
Nijmegen (UMCN) in the Netherlands, concluded that the use of
Combidex-enhanced MR imaging allows for the detection of small and
otherwise undetectable lymph node metastases in patients with prostate
cancer.
- During the 50th Annual Meeting of the Society of Nuclear Medicine
(SNM) held from June 21, 2003 through June 25, 2003 in New Orleans,
LA, Cytogen, Siemens Medical Solutions, and the University Hospitals
of Cleveland announced a partnership to promote breakthroughs in
prostate cancer imaging. Through this
partnership, physicians at the University Hospitals of Cleveland are
using the Siemens e.cam(TM) gamma camera with Flash 3D iterative
reconstruction and CT attenuation correction technology, in
combination with Cytogen's ProstaScint imaging agent. The resulting
images may provide major improvements for the diagnosis and staging of
metastatic prostate cancer.
- Also during SNM, GE Medical Systems, a unit of General Electric
Company, announced that it formed an alliance with Cytogen to market a
total molecular imaging system to help evaluate the extent and spread
of prostate cancer by integrating GE Medical's Infinia(TM) Hawkeye(R)
imaging system with Cytogen's ProstaScint imaging agent. GE's
revolutionary Infinia Hawkeye imaging system combines the anatomic
detail of computed tomography (CT) with the molecular imaging data
provided by nuclear medicine cameras using products such as Cytogen's
ProstaScint. The Infinia Hawkeye provides CT-based attenuation
correction and localization for single-photon emission computed
tomography (SPECT) studies that can help address the inherent
limitations of SPECT imaging.
- Lastly during SNM, clinical investigators from cancer research centers
around the world presented new clinical data regarding the use of
ProstaScint and Quadramet in multiple cancers. The investigational
studies detailed new advances in molecular imaging technology for
prostate cancer using ProstaScint and the potential synergies of
Quadramet with chemotherapy for the treatment of metastatic
hormone-refractory prostate cancer, pain palliation in solid tumor
cancers, and higher dose usage to target and treat primary bone
cancers.
NOTE:
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 in
post-prostatectomy patients 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.
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.
A copy of the full prescribing information for ProstaScint and Quadramet 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.
Cytogen's management will discuss the Company's second quarter 2003 results with
the investment community during a conference call beginning at 4:30 pm Eastern
Time on Thursday, August 14, 2003. To participate in the conference call,
domestic callers dial (877) 780-2271 and international callers dial (973)
582-2737 or log onto the investor relations section of Cytogen's website at
http://www.cytogen.com/ir.html and click on the webcast link to access the live
call.
An audio replay of the call will also be available at the same website address,
starting approximately one hour after the call and continuing for 45 days
thereafter. A telephone replay of the call will also be available for 7 days.
Domestic callers dial (877) 519-4471 and international callers dial (973)
341-3080 (Replay passcode # 4089472).
About Cytogen Corporation
Cytogen Corporation of Princeton, NJ is a product-driven, oncology-focused
biopharmaceutical company. Cytogen markets proprietary and licensed oncology
products through its in-house specialty sales force: Quadramet(R) (a skeletal
targeting therapeutic radiopharmaceutical for the relief of pain due to bone
metastases); ProstaScint(R) (a monoclonal antibody-based imaging agent used to
image the extent and spread of prostate cancer); and NMP22(R) BladderChek(TM) (a
point-of-care, IN VITRO diagnostic test for bladder cancer). Cytogen has
exclusive U.S. marketing rights to Combidex(R), an ultrasmall superparamagnetic
iron oxide contrast agent for magnetic resonance imaging of lymph nodes that is
pending clearance by the U.S. Food and Drug Administration. Cytogen's pipeline
comprises product candidates at various stages of clinical development,
including fully human monoclonal antibodies and cancer vaccines based on PSMA
(prostate specific membrane antigen) technology, which was exclusively licensed
from Memorial Sloan-Kettering Cancer Center. Cytogen also conducts research in
cellular signaling through its AxCell Biosciences research division in Newtown,
PA. 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. THE WORDS "ANTICIPATES," "BELIEVES," "ESTIMATES," "EXPECTS,"
"INTENDS," "MAY," "PLANS," "PROJECTS," "WILL," "WOULD" AND SIMILAR EXPRESSIONS
ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS, ALTHOUGH NOT ALL
FORWARD-LOOKING STATEMENTS CONTAIN THESE IDENTIFYING WORDS. 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, AND THE RISK
ASSOCIATED WITH CYTOGEN'S DEPENDENCE ON ITS PARTNERS FOR DEVELOPMENT OF CERTAIN
PROJECTS. CYTOGEN CANNOT GUARANTEE THAT CYTOGEN WILL ACTUALLY ACHIEVE THE PLANS,
INTENTIONS OR EXPECTATIONS DISCLOSED IN ANY SUCH FORWARD-LOOKING STATEMENTS.
CYTOGEN'S ACTUAL RESULTS MAY DIFFER MATERIALLY FROM CYTOGEN'S HISTORICAL RESULTS
OF OPERATIONS AND THOSE DISCUSSED IN SUCH FORWARD-LOOKING STATEMENTS AND THE
RISKS STATED ABOVE FOR VARIOUS REASONS, INCLUDING, BUT NOT LIMITED TO, CYTOGEN'S
ABILITY TO CARRY OUT ITS BUSINESS AND FINANCIAL PLANS, TO SUCCESSFULLY
COMMERCIALIZE QUADRAMET(R), TO DETERMINE AND IMPLEMENT THE APPROPRIATE STRATEGIC
INITIATIVE FOR ITS AXCELL BIOSCIENCES SUBSIDIARY, TO FUND DEVELOPMENT NECESSARY
FOR EXISTING PRODUCTS AND TO PURSUE NEW PRODUCT OPPORTUNITIES, TO INTEGRATE
IN-LICENSED PRODUCTS SUCH AS NMP22(R) BLADDERCHEK(TM), TO ESTABLISH AND
SUCCESSFULLY COMPLETE CLINICAL TRIALS WHERE REQUIRED FOR PRODUCT APPROVAL, TO
OBTAIN FOREIGN REGULATORY APPROVALS FOR PRODUCTS AND TO ESTABLISH MARKETING
ARRANGEMENTS IN COUNTRIES WHERE APPROVAL IS OBTAINED, AND OTHER FACTORS
DISCUSSED IN CYTOGEN'S FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2002, AS
AMENDED, AND FROM TIME-TO-TIME IN CYTOGEN'S OTHER FILINGS WITH THE SECURITIES
AND EXCHANGE COMMISSION. ANY FORWARD-LOOKING STATEMENTS MADE BY CYTOGEN DO NOT
REFLECT THE POTENTIAL IMPACT OF ANY FUTURE ACQUISITIONS, MERGERS, DISPOSITIONS,
JOINT VENTURES OR INVESTMENTS CYTOGEN MAY MAKE. CYTOGEN DOES NOT ASSUME, AND
SPECIFICALLY DISCLAIMS, ANY OBLIGATION TO UPDATE ANY FORWARD-LOOKING STATEMENTS,
AND THESE STATEMENTS REPRESENT CYTOGEN'S CURRENT OUTLOOK ONLY AS OF THE DATE
GIVEN.
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CYTOGEN CORPORATION & SUBSIDIARIES
(ALL AMOUNTS IN THOUSANDS EXCEPT PER SHARE DATA)
(UNAUDITED)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30, JUNE 30,
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2003 2002 2003 2002
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Revenues:
Marketed Product Sales $ 1,697 $ 2,592 $ 3,582 $ 5,174
Royalty Revenue 465 510 914 1,009
License and Contract 164 65 307 280
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Total Revenues 2,326 3,167 4,803 6,463
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Operating Expenses:
Cost of Product Related Revenues 900 1,241 1,810 2,295
Ongoing Research and Development 771 1,746 1,604 3,545
Equity Loss in PSMA LLC 1,086 595 1,966 1,108
Selling and Marketing 1,174 1,622 2,476 3,075
General and Administrative 1,740 1,200 2,816 2,710
Milestone Payment Related to
Research and Development* - - - 2,000
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Total Operating Expenses 5,671 6,404 10,672 14,733
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Non-Operating Income (Expense), net (23) 30 (34) 65
Income Tax Benefit - - (584) -
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Net Loss $(3,368) $(3,207) $(5,319) $(8,205)
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Basic and Diluted Net Loss Per Share $ (0.37) $ (0.39) $ (0.60) $ (1.00)
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Weighted Average Common Shares Outstanding 9,051 8,308 8,909 8,217
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* In 2002, the Company recorded a non-cash milestone payment related to the
progress of the cancer clinical trials.
CONDENSED CONSOLIDATED BALANCE SHEETS
JUNE 30, DECEMBER 31,
2003 2002
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Assets
Cash and Cash Equivalents $ 13,529 $ 14,725
Accounts Receivable, net 1,290 1,778
Inventories 2,029 1,262
Property and Equipment, net 783 1,072
Other Assets 1,335 1,057
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Total Assets $ 18,966 $ 19,894
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Liabilities & Stockholders' Equity
Accounts Payable & Accrued Liabilities $ 3,839 $ 4,427
Other Current Liabilities 75 80
Long-Term Liabilities & Deferred Revenues 4,528 4,799
Stockholders' Equity 10,524 10,588
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Total Liabilities & Stockholders' Equity $ 18,966 $ 19,894
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