COMPANY CONTACT:
Cytogen Corporation
Stacy Shearer
Investor Relations
(609) 750-8289
sshearer@cytogen.com
CYTOGEN REPORTS FOURTH QUARTER AND FULL YEAR 2004 RESULTS
PRINCETON, N.J., (FEBRUARY 23, 2005) -- Cytogen Corporation (Nasdaq: CYTO), a
product-driven biopharmaceutical company, today reported its financial results
for the fourth quarter and full year ended December 31, 2004.
FOURTH QUARTER & FULL YEAR 2004 FINANCIAL HIGHLIGHTS
- ----------------------------------------------------
o Consistent with the Company's previously issued revised financial guidance
for 2004, total product revenues were a record $14.5 million in 2004
compared to $9.8 million in 2003, driven by 10% year-over-year growth in
PROSTASCINT(R) (capromab pendetide) sales and the positive contribution of
QUADRAMET(R) (samarium Sm-153 lexidronam injection) following the
reacquisition of marketing rights to that product in 2003.
o For the year ended December 31, 2004, Cytogen reported a net loss of $20.5
million, or $1.40 per basic and diluted share, compared to $9.4 million, or
$0.92 per basic and diluted share, for the same period in 2003.
o In 2004, Cytogen achieved an average gross margin of approximately 36%,
which reflects QUADRAMET and PROSTASCINT manufacturing costs and royalties
to Dow Chemical and Berlex Laboratories.
o Aggregate selling, general and administrative, internal research and
development, and joint venture research and development expenses were $26.4
million in 2004, which compares favorably to the Company's guidance of
$26.5 million to $27.2 million.
o Fourth quarter product revenues totaled $3.7 million in 2004 compared to
$3.4 million in 2003, driven primarily by 18% year-over-year growth in
QUADRAMET sales.
o For the fourth quarter of 2004, Cytogen reported a net loss of $6.3
million, or $0.41 per basic and diluted share, compared to a net loss of
$3.1 million, or $0.26 per basic and diluted share, for the same period in
2003.
"2004 was a successful and productive year for Cytogen as we executed on our
strategies for enhancing our commercial infrastructure to support both existing
and future oncology products," said Michael D. Becker, Cytogen's President and
Chief Executive Officer. "For 2005, we will remain focused on achieving strong
sales growth while simultaneously expanding the development of our marketed
products beyond their current indications through new and ongoing clinical
studies, advancing our development pipeline, and executing on our business
development initiatives."
PRODUCT REVENUE
- ---------------
QUADRAMET
Sales of QUADRAMET, a fast-acting, long-lasting non-opioid treatment for the
relief of pain due to metastatic bone disease arising from prostate, breast,
multiple myeloma and other types of cancer, were $1.9 million for the quarter
ended December 31, 2004 compared to $1.6 million for the same period in 2003.
For the year ended
December 31, 2004, QUADRAMET sales were $7.3 million compared to $2.8 million
for the same period in 2003.
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 year ended December 31, 2003 was $1.1 million. On August 1,
2003, Cytogen reacquired these marketing rights from Berlex in exchange for an
upfront cash payment of $8.0 million and royalties based on future sales of
QUADRAMET. At that time, Cytogen began recording product revenue from the sales
of QUADRAMET.
QUADRAMET REVENUE SUMMARY
($'s in millions)
2003 2003 2003 2003 2004 2004 2004 2004
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
---- ---- ---- ---- ---- ---- ---- ----
Product Sales n/a n/a $1.2 $1.6 $1.9 $1.6 $1.9 $1.9
Royalties $0.4 $0.5 $0.2 n/a n/a n/a n/a n/a
---- ---- ---- ---- ---- ---- ---- ----
TOTAL: $0.4 $0.5 $1.4 $1.6 $1.9 $1.6 $1.9 $1.9
PROSTASCINT
Sales of PROSTASCINT kits for the preparation of Indium In-111 capromab
pendetide, the first and only commercial monoclonal antibody-based agent
targeting prostate-specific membrane antigen (PSMA) to image the extent and
spread of prostate cancer, were $1.8 million for each of the quarters ended
December 31, 2004 and 2003. For the year ended December 31, 2004, PROSTASCINT
sales were $7.2 million compared to $6.5 million for the same period in 2003.
PROSTASCINT REVENUE SUMMARY
($'s in millions)
2003 2003 2003 2003 2004 2004 2004 2004
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
---- ---- ---- ---- ---- ---- ---- ----
Product Sales $1.6 $1.6 $1.5 $1.8 $1.7 $2.3 $1.3 $1.8
OTHER PRODUCT REVENUE
- ---------------------
Other product revenue, consisting of both brachytherapy products and a
point-of-care diagnostic test for bladder cancer, were not significant in the
fourth quarter or year ended December 31, 2004 compared to $56,000 and $535,000
in the fourth quarter and year ended December 31, 2003, respectively. Cytogen
discontinued marketing brachytherapy products effective January 24, 2003 and the
diagnostic test for bladder cancer effective December 31, 2004.
LICENSE AND CONTRACT REVENUE
- ----------------------------
License and contract revenue for the fourth quarter of 2004 was $67,000 compared
to $87,000 for the same period in 2003. For the year ended December 31, 2004,
license and contract revenue was $139,000 compared to $2.9 million for the same
period in 2003. License and contract revenue for the year ended December 31,
2003 included the accelerated recognition of $1.9 million of previously deferred
revenue as a result of the Company's termination of the 1998 license agreement
for QUADRAMET with Berlex Laboratories in August 2003.
COSTS AND EXPENSES
- ------------------
Total operating expenses for the quarter ended December 31, 2004 were $10.5
million compared to $7.0 million for the same period in 2003. For the year ended
December 31, 2004, total operating expenses were $35.7 million compared to $24.0
million for the same period in 2003. Cost of product related revenues in 2004
primarily reflect QUADRAMET and PROSTASCINT manufacturing costs, royalties paid
by Cytogen to Dow Chemical and Berlex Laboratories on the Company's sales of
QUADRAMET, and the amortization of the up-front payment to Berlex to reacquire
the marketing rights to QUADRAMET. The year-over-year increase in selling,
general and administrative expenses is primarily driven by an expansion of the
Company's sales force and the implementation of new marketing initiatives for
the Company's existing and anticipated 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
PSMA. Cytogen's share of the equity in the loss of PDC was $740,000 for the
fourth quarter of 2004 compared to $772,000 for the same period in 2003. For the
year ended December 31, 2004, Cytogen's share of the equity in the loss of PDC
was $2.9 million compared to $3.5 million for the same period of 2003.
CASH POSITION
- -------------
Cytogen's cash, cash equivalents and short-term investments balance as of
December 31, 2004 was $35.8 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.
2004 HIGHLIGHTS
- ---------------
QUADRAMET
o Publication of a prospective, randomized, double-blind multi-center phase
III study confirming that QUADRAMET provides significant pain relief from
metastatic bone disease arising from prostate cancer. The study appeared in
the May 2004 issue of the peer-reviewed medical journal Urology (Sartor, O.
et al, "Samarium-153-Lexidronam Complex for Treatment of Painful Bone
Metastases in Hormone- Refractory Prostate Cancer," Urology, Volume 63, No.
5, pp. 940-945).
o Initiation of the National Bone Pain Management Registry, a major new
initiative related to QUADRAMET, in November 2004. Throughout December
2004, more than 50 oncology sites were enrolled in the program. Data
regarding both the use of QUADRAMET and best practices in bone pain
management will be collected from more than 500 patients. Results of this
initiative are expected to be presented at key medical meetings following
the conclusion of the initial phase of this program in mid-2005.
o Researchers from several institutions presented new clinical data regarding
QUADRAMET's potential role as a targeted oncology product in various
settings, including both higher dose applications and combinations with
chemotherapeutics, bisphosphonates, and other potentially synergistic
agents at the American Society of Clinical Oncology, Society of Nuclear
Medicine, International Society of Pediatric Oncology, and Prostate Cancer
Foundation annual meetings.
o Initiation of a phase I/II clinical trial under Cytogen's investigational
new drug (IND) application by researchers at The University of Texas M. D.
Anderson Cancer Center in Houston, Texas to investigate the use of
QUADRAMET in combination with docetaxel (Taxotere(R), Aventis
Pharmaceuticals, a member of the sanofi-aventis Group) for the treatment of
hormone refractory prostate cancer.
o Cytogen entered into a research collaboration with the Institute for
Myeloma & Bone Cancer Research wherein the parties will be investigating
the use of QUADRAMET both alone and in combination with other active
therapies for the treatment of multiple myeloma.
PROSTASCINT
o Researchers from several institutions presented new advances in molecular
imaging with PROSTASCINT at the Society of Nuclear Medicine and
Radiological Society of North America annual meetings.
o Publication of a study demonstrating improved three-year biochemical
control of recurrent prostate cancer with external beam radiation therapy
aided by advanced molecular imaging with PROSTASCINT. Results from the
study appeared in The Journal of Nuclear Medicine (Jani, AB. et al,
"Radioimmunocintigraphy for Postprostatectomy Radiotherapy: Analysis of
Toxicity and Biochemical Control," The Journal of Nuclear Medicine, Volume
45, No. 8, pp. 1315-1322).
o Publication of clinical data demonstrating that overexpression of PSMA in
primary prostate cancer correlates with other adverse traditional
prognostic factors and independently predicts disease recurrence.
Overexpression of PSMA was determined by immunohistochemical staining using
the PROSTASCINT monoclonal antibody (7E11.C5) and appeared in the medical
journal Clinical Cancer Research (Ross, JS. et al, "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).
COMBIDEX
o Cytogen and Advanced Magnetics, Inc. announced the submission of a complete
response to the approvable letter received from the U.S. Food and Drug
Administration (FDA) for COMBIDEX(R) (ferumoxtran-10), which was accepted
by the FDA and assigned a user fee goal date of March 30, 2005. COMBIDEX is
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. The
FDA's Oncologic Drugs Advisory Committee (ODAC) is scheduled to review the
regulatory filing for COMBIDEX on March 3, 2005.
OTHER PRODUCT CANDIDATES
o Cytogen and Progenics Pharmaceuticals, Inc. announced the award of grants
totaling $7.4 million over four years from the National Institutes of
Health (NIH) that will be used to develop novel immunotherapies for
prostate cancer based on prostate-specific membrane antigen (PSMA), a
promising target highly expressed on the surface of prostate cancer cells
and the neovasculature of solid tumors.
OTHER HIGHLIGHTS
o Cytogen's management team was strengthened with the additions of Thomas S.
Lytle as Senior Vice President of Sales and Marketing, Michael J. Manyak,
M.D., as Vice President of Medical Affairs, and William J. Thomas, Esq., as
Senior Vice President and General Counsel.
2005 CORPORATE OBJECTIVES
- -------------------------
In 2005, Cytogen remains focused on maximizing the commercial potential of
QUADRAMET and PROSTASCINT, as well as advancing our clinical programs and
executing our overall corporate strategy. The Company has outlined the following
corporate objectives for 2005:
o Expand development of QUADRAMET beyond the current palliative indication by
advancing ongoing clinical studies and initiating new clinical programs for
both higher dose applications and combination approaches with
chemotherapeutics, bisphosphonates, and other potentially synergistic
agents for the treatment of solid and hematological malignancies;
o Expand development of PROSTASCINT beyond the current diagnostic indication
by advancing ongoing clinical studies and initiating new clinical programs
for PROSTASCINT-guided therapy, monitoring response to cytotoxic therapy,
and imaging other malignancies;
o Develop and implement a national PROSTASCINT registry designed to obtain
data regarding the potential independent prognostic value of PSMA
expression, best practices in fusion imaging to detect the extent and
location of prostate cancer, and to better define the clinical utility of
PROSTASCINT in guiding treatment planning and decision making;
o Complete the phase I trial of a recombinant soluble prostate-specific
membrane antigen (rsPSMA) prostate cancer vaccine;
o Advance our development pipeline consisting of therapeutics targeting
prostate-specific membrane antigen (PSMA), including the filing of an
Investigational New Drug application (IND); and
o Complete pre-launch preparations for COMBIDEX.
FINANCIAL OUTLOOK FOR 2005:
This section provides forward-looking information about Cytogen's financial
outlook for 2005 based upon our current operations. The disclosure notice
paragraph regarding forward-looking statements at the end of this news release
is especially applicable to this section.
Consistent with the Company's past practices for providing guidance when a
product candidate is undergoing FDA review, this financial guidance excludes any
revenue contribution from COMBIDEX, but includes all COMBIDEX-related expenses
through initial market launch.
For the year ending December 31, 2005, the Company currently expects:
o Total revenue of approximately $20 to $25 million;
o Average gross margin of approximately 40% to 50%;
o Selling, general and administrative expenses totaling approximately $30 to
$35 million; and
o Total internal and external joint venture research and development expenses
of approximately $10 to $15 million.
CONFERENCE CALL & WEBCAST INFORMATION
- -------------------------------------
Cytogen will broadcast its quarterly investor conference call live over the
Internet today, February 23, 2005 at 9:00 a.m. Eastern Standard Time. The
dial-in number for the U.S. is 888-396-2386 and the pass code number is
29512202. The dial-in number for international callers is 617-847-8712 and the
pass code number is 29512202. This event can also be accessed by going to
Cytogen's Web site, www.cytogen.com, and clicking on the "Investor Relations"
link. 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. 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 14815746.
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 and PROSTASCINT 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
biopharmaceutical company that develops and commercializes innovative molecules
that can be used to build leading franchises across multiple markets. Cytogen's
marketed products include QUADRAMET(R) (samarium Sm-153 lexidronam injection)
and PROSTASCINT(R) (capromab pendetide) kit for the preparation of Indium In-111
capromab pendetide in the United States. Cytogen also has exclusive United
States marketing rights to COMBIDEX(R) (ferumoxtran-10) for all applications,
and the exclusive right to market and sell ferumoxytol (previously Code 7228)
for oncology applications in the United States. COMBIDEX, an investigational
molecular imaging agent consisting of iron oxide nanoparticles, is currently
being developed for use in conjunction with magnetic resonance imaging to aid in
the differentiation of cancerous and non-cancerous lymph nodes, and is under
review by the U.S. Food and Drug Administration. Cytogen's development pipeline
consists of 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 TWELVE MONTHS ENDED
DECEMBER 31, DECEMBER 31,
------------------ -------------------
2004 2003 2004 2003
---- ---- ---- ----
Product Revenue:
QUADRAMET $ 1,899 $ 1,606 $ 7,293 $ 2,765
PROSTASCINT 1,839 1,785 7,186 6,523
Others - 56 1 535
----------- ----------- ---------- -----------
Total Product Revenue 3,738 3,447 14,480 9,823
Royalty Revenue - - - 1,105
License and Contract Revenue * 67 87 139 2,914
----------- ----------- ---------- -----------
Total Revenues 3,805 3,534 14,619 13,842
----------- ----------- ---------- -----------
Operating Expenses:
Cost of Product Related Revenue 2,326 2,419 9,309 6,268
Selling, General and Administrative 6,170 3,721 20,318 11,867
Research and Development 1,253 59 3,206 2,342
Equity in Loss of Joint Venture 740 772 2,896 3,452
Impairment of Intangible Asset - - - 115
----------- ----------- ---------- -----------
Total Operating Expenses 10,489 6,971 35,729 24,044
----------- ----------- ---------- -----------
Interest Income (Expense), Net 99 4 263 (44)
Income Tax Benefit (307) (304) (307) (888)
----------- ----------- ---------- -----------
Net Loss $ (6,278) $ (3,129) $ (20,540) $ (9,358)
=========== =========== ========== ===========
Basic and Diluted Net Loss Per Share $ (0.41) $ (0.26) $ (1.40) $ (0.92)
=========== =========== ========== ===========
Weighted Average Common Shares
Outstanding 15,454 12,087 14,654 10,205
=========== =========== ========== ===========
* During the third quarter of 2003, the Company recorded $1.9 million in revenue
related to the acceleration of previously deferred revenue as a result of the
termination of the 1998 license agreement for QUADRAMET with Berlex
Laboratories.
CONDENSED CONSOLIDATED BALANCE SHEETS
DECEMBER 31, DECEMBER 31,
2004 2003
--------------- --------------
Assets:
Cash, Cash Equivalents and Short-Term Investments $ 35,825 $ 30,215
Accounts Receivable, Net 1,406 1,445
Inventories 3,623 1,887
Property and Equipment, Net 787 595
QUADRAMET License Fee, Net 7,024 7,720
Other Assets 1,748 1,833
------------ ------------
Total Assets $ 50,413 $ 43,695
============ ============
Liabilities and Stockholders' Equity:
Accounts Payable and Accrued Liabilities $ 8,040 $ 5,125
Other Current Liabilities 2,296 76
Long-Term Liabilities 47 2,454
Stockholders' Equity 40,030 36,040
------------ ------------
Total Liabilities and Stockholders' Equity $ 50,413 $ 43,695
============ ============