Exhibit 99.1
IMMEDIATE RELEASE November 11, 2004
CONTACTS:
Brent Larson, Tim Ryan,
Vice President / CFO The Trout Group
614 793 7500 212 477 9007
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NEOPROBE PROVIDES THIRD QUARTER RESULTS & BUSINESS UPDATE
Quarterly Revenue Increases 46% and Operating Loss Declines by 64%
Conference Call Scheduled
DUBLIN, OHIO - November 11, 2004 -- Neoprobe Corporation (OTCBB: NEOP), a
diversified developer of innovative oncology and cardiovascular surgical and
diagnostic products, today announced consolidated operating results for the
third quarter of 2004. Third quarter results included revenues of $1.7 million,
representing increases of 46% compared to $1.2 million for the third quarter of
2003 and 11% compared to $1.5 million for the second quarter of 2004. In
addition, Neoprobe reported a net loss of $239,000 or $0.00 per share for the
third quarter of 2004 compared to a loss of $659,000 or $0.02 per share for the
same period in 2003. The smaller operating loss in the third quarter represented
an improvement of 64% compared to third quarter 2003. Total operating expenses
were $1.3 million for the third quarter of 2004 compared to $1.3 million for the
third quarter of 2003.
David Bupp, Neoprobe's President and CEO said, "Our third quarter revenue
reflects continued strong performance for our gamma devices. In addition, our
gross margin on net device sales improved to 58% for third quarter 2004 from 46%
during the same period in 2003 due primarily to the design modifications
implemented on the neo2000(R) system coupled with the change in contract
manufacturers."
Neoprobe made its first shipment of Quantix(R) products during the third quarter
to our distributor in Japan, Century Medical, Inc. The development activities
associated with the Quantix/OR(TM) system that were initiated in the second
quarter have now been substantially completed. The software portion of the
modifications was released at the end of the third quarter and the new flexible
probe is expected to be available for commercial shipment to our distributors in
Europe and Asia later in the fourth quarter. In addition, Neoprobe is in the
process of filing for regulatory clearance with the U.S. FDA to market the new
Quantix/OR probe and expects a United States launch in the first quarter of
2005. Mr. Bupp stated, "Although revenue from our blood flow line has been lower
than planned this year, the feedback we have received related to the new probe
design and enhanced software features is extremely positive and we remain
confident that the product modifications that have been completed will lead to
market acceptance of our Cardiosonix products."
Operating expenses during the quarter remained consistent with those in the
prior year period despite activities to support the re-initiation of our RIGS(R)
research effort, development activities related to Lymphoseek(TM), and product
refinement activities related to the Quantix/OR. Of these operating expenses,
$261,000 were non-cash in nature for 2004 compared to $169,000 in similar
non-cash expenses for the third quarter of 2003. Bupp continued, "During the
third quarter we initiated clinical and manufacturing efforts in support of the
development of Lymphoseek. In addition, we completed the preparation of a
regulatory submission to commence the review of the Phase III protocol and
continued to engage the biologic and radiolabeling facilities to support the
commencement of clinical studies of the RIGS technology in 2005. Finally, we
remain positive about the outlook for our Quantix blood flow devices and believe
the product refinements we have completed will facilitate user interface and
support the underlying technology platform."
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NEOPROBE CORPORATION
ADD - 2
Recent milestones:
o Lymphoseek clinical protocol submitted to FDA
We submitted a Phase III protocol to FDA for their review and
comment in October. The proposed clinical protocol is designed to
demonstrate that Lymphoseek is a reliable lymphatic tissue tracing
agent. The clinical protocol design is consistent with the comments
the company received during a meeting with the Interagency Council
for Biomedical Oncology Products last November.
o Initial FDA response received to RIGScan(R) CR protocol submission
We received FDA comments to our clinical development program and are
in the process of incorporating the comments into our final trial
design and development plan. Based on guidance from FDA, we intend
to seek a special protocol assessment (SPA) from FDA of the Phase
III protocol and associated materials.
o Lymphoseek and RIGS manufacturing activities
During the third quarter, Neoprobe executed agreements to secure
manufacturing capability to support the proposed Phase III clinical
development program and the commercial launch of Lymphoseek. In
addition, an agreement with a radiolabeling contractor is being
finalized to support the validation of radiolabeling RIGScan CR for
a Phase III study next year.
o 64% reduction in operating loss over the prior year
Increases in gamma device product revenue coupled with improvement
of gross margin for the product contributed to a reduction in the
company's operating loss. The reduction in the operating loss
occurred even as Neoprobe focused additional resources to support
the development of Lymphoseek and RIGScan CR.
Neoprobe's CEO, David Bupp, and CFO, Brent Larson, will discuss the operating
results and current status of ongoing activities via a conference call scheduled
for 11:00 AM EDT today, November 11, 2004. Participants may dial-in by calling
877-407-8289 from the United States and Canada or by calling 201-689-8341
internationally. A replay of the call will be available for one week by calling
877-660-6853 (Replay Access Code: 1628, Conference ID: 124348) from the United
States and Canada or by calling 201-612-7415 internationally.
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NEOPROBE CORPORATION
ADD - 3
About Neoprobe
Neoprobe develops and provides innovative surgical and diagnostic products that
enhance patient care by meeting the critical decision making needs of healthcare
professionals. Neoprobe currently markets the neo2000(R) line of gamma detection
systems that are widely used by cancer surgeons for intraoperative lymphatic
mapping. Neoprobe is also in the process of commercializing the Quantix(R) line
of blood flow measurement products developed by its subsidiary, Cardiosonix
Ltd., that are designed to be used by cardiovascular surgeons, neurosurgeons and
critical care physicians. In addition, Neoprobe holds significant interests in
the development of related biomedical systems and agents including
Lymphoseek(TM) and RIGScan(R) CR. Lymphoseek is an investigational drug being
developed as a lymphatic tracing agent in conjunction with the University of
California, San Diego. The RIGS(R) system is an investigational technology that
combines the Company's gamma detection device technology with a proprietary
disease-specific radiolabeled cancer targeting agent, and a patented surgical
method to get real-time information to locate tumor deposits that may not be
detectable by conventional methods. Before surgery, a cancer patient is injected
with one of the targeting agents, which circulates throughout the patient's body
and binds specifically to cancer cell antigens or receptors. Concentrations of
the targeting agent are then located during surgery by the company's
gamma-detection instrument, which emits an audible tone to direct the surgeon to
targeted tissue. The Company's strategy is to deliver superior growth and
shareholder return by maximizing its strong position in gamma detection
technologies and diversifying into new, synergistic biomedical markets through
continued investment and selective acquisitions.
Statements in this news release, which relate to other than strictly historical
facts, such as statements about the Company's plans and strategies, expectations
for future financial performance, new and existing products and technologies,
and markets for the Company's products, are forward-looking statements. The
words "believe," "expect," "anticipate," "estimate," "project," and similar
expressions identify forward-looking statements that speak only as of the date
hereof. Investors are cautioned that such statements involve risks and
uncertainties that could cause actual results to differ materially from
historical or anticipated results due to many factors including, but not limited
to, the Company's continuing operating losses, uncertainty of market acceptance
of its product, reliance on third party manufacturers, accumulated deficit,
future capital needs, uncertainty of capital funding, dependence on limited
product line and distribution channels, competition, limited marketing and
manufacturing experience, risks of development of new products, regulatory risks
and other risks detailed in the Company's most recent Annual Report on Form
10-KSB and other Securities and Exchange Commission filings. The Company
undertakes no obligation to publicly update or revise any forward-looking
statements.
NEOPROBE CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, December 31,
2004 2003
(unaudited)
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Assets:
Cash and cash equivalents $3,008,201 $1,588,760
Other current assets 1,839,986 2,462,575
Intangible assets, net 2,629,395 2,935,515
Other non-current assets 483,605 398,192
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Total assets $7,961,187 $7,385,042
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Liabilities and stockholders' equity:
Current liabilities, excluding deferred revenue $ 694,989 $ 654,341
Deferred revenue 249,290 955,587
Other liabilities 85,355 516,169
Stockholders' equity 6,931,553 5,258,945
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Total liabilities and stockholders' equity $7,961,187 $7,385,042
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended Nine Months Ended
September 30, September 30, September 30, September 30,
2004 2003 2004 2003
(unaudited) (unaudited) (unaudited) (unaudited)
------------ ------------ ------------ ------------
Revenues:
Net sales $ 1,525,134 $ 927,949 $ 4,098,679 $ 3,868,655
License revenue and other 200,000 257,588 600,000 745,633
------------ ------------ ------------ ------------
Total revenues 1,725,134 1,185,537 4,698,679 4,614,288
------------ ------------ ------------ ------------
Cost of goods sold 643,303 497,458 1,692,084 2,112,247
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Gross profit 1,081,831 688,079 3,006,595 2,502,041
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Operating expenses:
Research and development 588,435 508,693 1,766,265 1,365,277
Selling, general and administrative 695,399 755,104 2,361,941 2,230,693
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Total operating expenses 1,283,834 1,263,797 4,128,206 3,595,970
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Loss from operations (202,003) (575,718) (1,121,611) (1,093,929)
Other expenses, net (36,755) (83,396) (135,597) (123,125)
------------ ------------ ------------ ------------
Net loss $ (238,758) $ (659,114) $ (1,257,208) $ (1,217,054)
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Loss per common share:
Basic $ (0.00) $ (0.02) $ (0.02) $ (0.03)
Diluted $ (0.00) $ (0.02) $ (0.02) $ (0.03)
Weighted average shares outstanding:
Basic 58,076,622 38,555,261 56,290,885 38,454,446
Diluted 58,076,622 38,555,261 56,290,885 38,454,446