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CYTOGEN REPORTS FIRST QUARTER 2005 FINANCIAL RESULTS
Company Reaffirms Guidance of Record Revenues in Fiscal 2005, Full-Year
Operating Expense Guidance Revised Downward
PRINCETON, N.J., (MAY 5, 2005) -- Cytogen Corporation (Nasdaq: CYTO), a
product-driven biopharmaceutical company, today reported its consolidated
financial results for the quarter ended March 31, 2005.
FIRST QUARTER FINANCIAL HIGHLIGHTS
- ----------------------------------
o Total product revenues for the first quarter of 2005 were $4.0 million
compared to $3.6 million in the first quarter of 2004 and $3.7 million
in the fourth quarter of 2004, representing 10% revenue growth
year-over-year and 6% sequential revenue growth from the fourth quarter
of 2004.
o Sales of QUADRAMET(R) (samarium Sm-153 lexidronam injection) were $2.1
million for the quarter ended March 31, 2005 compared to $1.9 million
for the same period in 2004 and fourth quarter of 2004, representing
11% revenue growth year-over-year and 8% sequential growth from the
fourth quarter of 2004. Unit sales for the quarter ended March 31, 2005
increased 8% from the same period in 2004 and 9% from the fourth
quarter of 2004.
o Sales of PROSTASCINT(R) (capromab pendetide) kits were $1.9 million for
the quarter ended March 31, 2005 compared to $1.7 million for the same
period in 2004 and $1.8 million in the fourth quarter of 2004,
representing 10% revenue growth year-over-year and consistent demand
from the fourth quarter of 2004. Unit sales for the quarter ended March
31, 2005 demonstrated consistent demand from the same period in 2004
and from the fourth quarter of 2004.
o Average gross margin improved to 39% for the quarter ended March 31,
2005 compared to 33% for the same period in 2004.
o Cytogen reported a net loss of $6.6 million, or $0.43 per basic and
diluted share in the first quarter of 2005, compared to $4.3 million,
or $0.33 per basic and diluted share, for the same period in 2004. The
increase in net loss results primarily from the continued expansion in
Cytogen's sales force, which was completed in January 2005.
"We remain steadfast in our belief that QUADRAMET, PROSTASCINT, and our
prostate-specific membrane antigen, or PSMA, development pipeline are the key
drivers of our business model, for which Cytogen has made solid progress during
the first quarter of 2005," said Michael D. Becker, President and Chief
Executive Officer. "Whether measured by units or revenue, we are encouraged by
the fact that QUADRAMET's performance in the first quarter of 2005 was the
highest in nearly three years, with the majority of demand occurring late in the
quarter as our expanded field presence began to have an impact. Additionally, we
are pleased with the progress made with respect to our pipeline of novel
therapies that target prostate-specific membrane antigen, or PSMA. We recently
announced a new clinical development initiative for a proprietary PSMA antibody
designed to treat prostate and potentially other cancers, with plans to submit
an investigational new drug (IND) application for this product candidate within
a year."
PRODUCT REVENUE
- ---------------
QUADRAMET
QUADRAMET, Cytogen's flagship product, is a fast-acting, long-lasting non-opioid
therapeutic alternative for the relief of pain due to metastatic bone disease
arising from prostate, breast, multiple myeloma and other types of cancer. Sales
of QUADRAMET were $2.1 million for the quarter ended March 31, 2005 compared to
$1.9 million for the same period in 2004.
QUADRAMET QUARTERLY REVENUE SUMMARY
($'s in millions)
2004 2004 2004 2004 | 2005
Q1 Q2 Q3 Q4 | Q1
---- ---- ---- ---- ----
Product Sales $1.9 $1.6 $1.9 $1.9 | $2.1
"QUADRAMET's demonstrated ability to reduce pain and the need for opioid-based
treatments in cancer patients, along with its safety, simplicity, convenience of
administration, and cost-effectiveness underscores our long-held belief that
this unique product addresses a significant and unmet medical need," said Thomas
Lytle, Cytogen's Senior Vice President of Sales and Marketing. "We are just
beginning to recognize the benefits of our 60-person-plus core commercial
organization including sales, marketing, and medical affairs functions and
targeted programs designed to increase awareness of QUADRAMET in both key
physician and patient audiences. These activities are expected to broaden the
use of QUADRAMET within its current palliative indication."
PROSTASCINT
Sales of PROSTASCINT kits (for the preparation of Indium In-111 capromab
pendetide), the first and only commercial monoclonal antibody-based agent that
targets PSMA to image the extent and spread of prostate cancer, were $1.9
million for the quarter ended March 31, 2005 compared to $1.7 million in the
same period of 2004.
PROSTASCINT QUARTERLY REVENUE SUMMARY
($'s in millions)
2004 2004 2004 2004 | 2005
Q1 Q2 Q3 Q4 | Q1
---- ---- ---- ---- ----
Product Sales $1.7 $2.3 $1.3 $1.8 | $1.9
COSTS AND EXPENSES
- ------------------
Total operating expenses for the quarter ended March 31, 2005 were $10.7 million
compared to $7.9 million for the same period in 2004.
COST OF PRODUCT REVENUE
Cost of product revenue for both the quarters ended March 31, 2005 and March 31,
2004 were $2.4 million and primarily reflect QUADRAMET and PROSTASCINT
manufacturing costs, royalties paid by Cytogen on the
Company's product sales, and the amortization of the up-front payment to Berlex
to reacquire the marketing rights to QUADRAMET.
SG&A EXPENSES
Selling, general and administrative expenses for the quarter ended March 31,
2005 were $7.0 million compared to $3.9 million for the same period in 2004. The
increase in selling, general and administrative expenses is primarily driven by
expanded investment for the commercial support of both QUADRAMET and
PROSTASCINT, including the continued expansion of the Company's sales force and
the implementation of new marketing initiatives.
R&D SPENDING
Internal research and development expenses for the quarter ended March 31, 2005
were $739,000 compared to $804,000 for the same period in 2004.
External research and development expenses 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 $498,000
for the first quarter of 2005 compared to $809,000 for the same period in 2004.
INVENTORIES
Inventories as of March 31, 2005 were $4.3 million compared to $3.6 million as
of December 31, 2004. The increase in inventories was due primarily to
manufacturing runs of PROSTASCINT. In September 2004, Cytogen entered into a
manufacturing agreement with Laureate Pharma, L.P. pursuant to which Laureate is
manufacturing PROSTASCINT for Cytogen in its Princeton, New Jersey facility.
Cytogen believes that the agreement will provide a sufficient supply of
PROSTASCINT to satisfy commercial requirements for approximately the next four
years, based upon current sales levels.
CASH POSITION
- -------------
Cytogen's cash, cash equivalents and short-term investments balance as of March
31, 2005 was $26.4 million compared to $35.8 million as of December 31, 2004.
FIRST QUARTER PRODUCT AND PIPELINE HIGHLIGHTS
- ---------------------------------------------
QUADRAMET
Four separate studies are evaluating the safety and preliminary efficacy of
administering QUADRAMET in combination with a variety of doses and dosing
regimens of taxane-based chemotherapy for the treatment of hormone refractory
prostate cancer. Two additional studies are evaluating the combination of
QUADRAMET with bisphosphonates, one study in patients with multiple myeloma and
the other in prostate cancer. These Company-sponsored studies are being
undertaken not only to evaluate potential therapeutic synergies of these
combinations of agents, but also to provide clinical data on the safety of
QUADRAMET in combination with these other agents commonly administered to
patients with bone metastases in the approved indication for palliation of pain.
PSMA
Cytogen recently announced a new development initiative for a targeted oncology
therapeutic based on Cytogen's proprietary 7E11 monoclonal antibody directed
against PSMA. This new therapeutic product
candidate utilizes DOTA-based bifunctional chelant technology to attach the beta
emitting radionuclide lutetium-177 as a payload to the 7E11 antibody, enabling
targeted delivery of this cytotoxic agent. Cytogen intends to develop the
resulting innovative molecule for the treatment of various cancers that express
the PSMA marker. Pre-clinical studies are underway in anticipation of filing an
IND application in the first quarter of 2006 for a Phase I study in patients
with prostate cancer.
UPCOMING EVENTS
- ---------------
QUADRAMET
o The following two abstracts are scheduled to be presented or published
at the American Society of Clinical Oncology (ASCO) annual meeting (May
13-17, 2005):
o "Repeated dose samarium 153 lexidronam (QUADRAMET) in patients
with prostate cancer bone metastases" is scheduled to be
presented on Saturday, May 14 from 8:00 a.m. to 12:00 p.m. during
the General Poster Session; and
o "Gemcitabine radiosensitization after 153Sm-EDTMP (QUADRAMET)
bone-seeking radioisotope therapy for osteoblastic lesions of
osteosarcoma: activity and principles" is scheduled to be
presented on Monday, May 16 from 8:00 a.m. to 12:00 p.m. during
the Poster Discussion Session.
o The following four abstracts are scheduled to be presented or published
at the Society of Nuclear Medicine (SNM) annual meeting (June 18 - 22,
2005):
o "Tumoricidal effects of Sm-153 EDTMP (QUADRAMET) in prostate
cancer" is scheduled to be presented on Sunday, June 19 from 6:00
p.m. to 6:45 p.m. during the Scientific Poster Session;
o "Treatment of painful bony metastases with samarium-153
lexidronam (QUADRAMET): a review" is scheduled to be presented on
Sunday, June 19 from 6:45 p.m. to 7:30 p.m. during the Scientific
Poster Session;
o "153Sm-EDTMP (QUADRAMET) plus chemotherapy in the treatment of
bone metastases from lung cancer" is scheduled to be presented on
Tuesday, June 21 from 4:30 p.m. to 5:15 p.m. during the
Scientific Poster Session; and
o "A novel study of the measurement of samarium-153-EDTMP bone
uptake rate and its relationship with therapeutic effect in
patients with bone metastases" is scheduled to be presented on
Tuesday, June 21 from 4:30 p.m. to 5:15 p.m. during the
Scientific Poster Session.
PSMA
o The following two abstracts are scheduled to be presented or published
at the ASCO annual meeting:
o "Novel prime-boost combinations of PSMA-based vaccines for
prostate cancer" is scheduled to be presented on Sunday, May 15
from 8:00 a.m. to 12:00 p.m. during the General Poster Session;
and
o "Molecular targeting of prostate cancer with cytotoxins and
radioisotopes linked to fully human monoclonal antibodies against
prostate-specific membrane antigen" is scheduled to be presented
on Sunday, May 15 from 8:00 a.m. to 12:00 p.m. during the General
Poster Session.
o The following abstract is scheduled to be presented or published at the
American Urological Association (AUA) annual meeting (May 21 - 26,
2005):
o "A negative indium-111-capromab pendetide (PROSTASCINT) scan may
still be useful" is scheduled to be presented on Wednesday, May
25 from 3:30 p.m. to 5:30 p.m. during a Podium Session on
Uroradiology.
o The following posters are scheduled to be presented or published at the
American Brachytherapy Society (ABS) annual meeting (June 1 - 3, 2005):
o "Seven year biochemical disease free survival rates following
permanent prostate brachytherapy with dose escalation to
biological tumor volumes (BTVs) identified with
SPECT(PROSTASCINT)/CT image fusion" is scheduled to be presented
at the meeting; and
o "Rectal morbidity following permanent prostate brachytherapy with
dose escalation to biological tumor volumes (BTVs) identified
with SPECT(PROSTASCINT)/CT image fusion" is scheduled to be
presented at the meeting.
o The following two abstracts are scheduled to be presented or published
at the SNM annual meeting:
o "Scatter correction techniques for prostate SPECT imaging using
indium 111 (PROSTASCINT)" is scheduled to be presented on Sunday,
June 19 from 6:45 p.m. to 7:30 p.m. during the Scientific Poster
Session; and
o "Translation of SPECT/CT (PROSTASCINT) guided prostate
brachytherapy to a community setting from the university setting
with a case example of histopathologic correlation to the image
set" is scheduled to be presented on Tuesday, June 21 from 4:30
p.m. to 5:15 p.m. during the Scientific Poster Session.
"As evidenced by more than a dozen abstracts scheduled for presentation or
publication at major medical meetings during the current quarter, we anticipate
that 2005 will be another important year for new data related to our marketed
products and development pipeline," said William Goeckeler, Ph.D., Senior Vice
President of Operations at Cytogen. "We are encouraged by this support and
interest in our oncology portfolio. Through both ongoing and planned clinical
development programs, we continue to make progress in unlocking the full
commercial potential of our products and pipeline."
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.
The Company reaffirms its previously issued full-year 2005 financial guidance,
with the exception of a downward revision in selling, general and administrative
expenses to reflect approximately $5 million of certain new product launch
expenses that the Company no longer expects to be recognized in 2005.
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 Revised selling, general and administrative expenses totaling
approximately $25 to $30 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, May 5, 2005 at 9:00 a.m. Eastern Standard Time. The dial-in
number for the U.S. is 1-800-659-1942 and the pass code number is 69636477. The
dial-in number for international callers is 1-617-614-2710 and the pass code
number is 69636477. 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 29606633.
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. 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. 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
MARCH 31,
-----------------------
2005 2004
--------- ---------
Product Revenue:
QUADRAMET $ 2,054 $ 1,854
PROSTASCINT 1,899 1,727
Others - 1
-------- --------
Total Product Revenue 3,953 3,582
License and Contract Revenue 41 19
-------- --------
Total Revenues 3,994 3,601
-------- --------
Operating Expenses:
Cost of Product Revenue 2,427 2,399
Selling, General and Administrative 7,024 3,891
Research and Development 739 804
Equity in Loss of Joint Venture 498 809
-------- --------
Total Operating Expenses 10,688 7,903
-------- --------
Interest Income, Net 101 20
-------- --------
Net Loss $ (6,593) $ (4,282)
======== ========
Basic and Diluted Net Loss Per Share $ (0.43) $ (0.33)
======== ========
Weighted Average Common Shares Outstanding 15,513 12,860
======== ========
CONDENSED CONSOLIDATED BALANCE SHEETS
MARCH 31, DECEMBER 31,
2005 2004
---------- ------------
Assets:
Cash, Cash Equivalents and Short-Term Investments $ 26,354 $ 35,825
Accounts Receivable, Net 1,801 1,406
Inventories 4,255 3,623
Property and Equipment, Net 851 787
QUADRAMET License Fee, Net 6,850 7,024
Other Assets 1,474 1,748
-------- --------
Total Assets $ 41,585 $ 50,413
======== ========
Liabilities and Stockholders' Equity:
Accounts Payable and Accrued Liabilities $ 5,159 $ 7,644
Other Current Liabilities 2,690 2,692
Long-Term Liabilities 42 47
Stockholders' Equity 33,694 40,030
-------- --------
Total Liabilities and Stockholders' Equity $ 41,585 $ 50,413
======== ========