NEOP News Neoprobe Announces Third Quarter Results
DUBLIN, Ohio--(BUSINESS WIRE)--Neoprobe Corporation (OTCBB:NEOP),
a diversified developer of innovative oncology and cardiovascular
surgical and diagnostic products, today announced financial results for
the third quarter of 2006 and for the nine-month period ended September
30, 2006. For the third quarter of 2006, Neoprobe reported a net loss of
$1.7 million or $0.03 per share compared to a net loss of $1.3 million
or $0.02 per share for the third quarter in 2005. For the nine months
ended September 30, 2006, Neoprobe reported a net loss of $3.4 million
or $0.06 per share compared to a net loss of $3.6 million or $0.06 per
share for the same period in 2005. The net loss for the third quarter of
2006 included $362,000 in non-cash charges compared to non-cash charges
of $331,000 for the third quarter of 2005. The net loss for each of the
nine-month periods ended September 30, 2006 and September 30, 2005
included $1.1 million in non-cash charges.
For the third quarter of 2006, Neoprobe reported total revenues of $1.0
million compared to $1.3 million for the third quarter in 2005. For the
nine-month period ended September 30, 2006, Neoprobe reported total
revenues of $4.2 million compared to total revenues of $4.5 million for
the same period in 2005.
For the third quarter of 2006, Neoprobe reported total operating
expenses of $1.9 million compared to $1.8 million for the third quarter
of 2005. For the nine-month period ended September 30, 2006, Neoprobe
reported total operating expenses of $5.0 million compared to $5.4
million for the same period in 2005.
Revenue from Neoprobe’s gamma device business
decreased compared to the prior year primarily due to an approximately
3% net price decline on approximately 10% lower sales volumes. Overall,
the gamma device business through the third quarter of 2006 was in line
with our expectations for the year. We expect volumes of our base
neo2000 systems to be closer to historical levels during the fourth
quarter of 2006. In addition, our primary marketing partner has
committed to purchase minimum quantities of our new Bluetooth®
probes and we are in the process of completing manufacturing scale-up
activities to meet their expected needs for the balance of 2006 and into
2007.
Our year-to-date sales of blood flow measurement equipment for 2006 are
80% greater than the comparable period from last year. Although this
increase is significant, sales of our blood flow measurement equipment
thus far have still not met our expectations. We are, however,
encouraged by activities related to our distribution relationship with
ESTECH, Inc. which was expanded during the third quarter to cover the
European Union. We are experiencing significantly more competitive
product evaluations in recent months following the completion of
training of the ESTECH sales force in the U.S. Further, we see the
marketplace continuing to transition to a “per
use” pricing methodology which, although it
does not result in recognizable revenue as rapidly as a capital
purchase, should result in longer term economic benefit to Neoprobe.
Finally, our Asian marketing partner has received clearance to market
the Quantix/OR™ product in certain Asian
markets and we expect to receive additional customer orders related to
those markets during 2007. Overall, we remain cautiously optimistic
about our blood flow measurement device business as we look toward the
remainder of 2006 and into early 2007.
We had originally hoped to provide top-line results for the first 40
patients in our Phase 2 trial of Lymphoseek®
during early October. Unfortunately, the time required to obtain the
necessary approvals from the Institutional Review Boards (IRBs) and to
then execute the research contracts at some of the participating
clinical institutions has taken longer than expected. We now have IRB
approval at four of the five participating institutions and are actively
enrolling patients at three of these sites. We are awaiting the
execution of the research contract at the fourth site in order to
commence enrollment in November. We expect to have IRB approval at the
fifth and final site in November so that patient enrollment can commence
there as well. While it is possible for us to complete the Phase 2 trial
with patients recruited from institutions that already are enrolling
patients in the Phase 2 study, we would like participation in the study
to be as broad as possible. Therefore, we do not expect to announce the
results from the first 40 patients prior to the end of the year. We do
not currently expect enrollment in the Phase 2 trial to be complete
until the first quarter of 2007. This will also mean that the
commencement of the Phase 3 trial will likely now begin sometime during
the latter part of the second quarter of 2007; however, we currently
plan to increase the number of participating institutions in the Phase 3
trial beyond our original target of 10 to 12 institutions in order to
enable us to accrue patients at a more rapid rate. Our goal is to file
the NDA for Lymphoseek by the end of 2007.
David Bupp, Neoprobe’s President and CEO,
said, “The administrative process of getting
the institutional consents to commence patient enrollment in the Phase 2
study has been more time consuming than expected and has been
frustrating to management and I’m sure to our
investors. We are encouraged that the results of the Phase 2 study to
date have been consistent with the earlier Phase 1 evaluations of
Lymphoseek. It remains our intention to provide more detailed
information to the investment community as soon as possible, but our
first commitment is to meet our regulatory obligation regarding the
reporting of results and to make sure that the studies are conducted
using the most appropriate and best clinical practices.”
The clinical sites involved in the Phase 2 study include University of
California, San Francisco, The John Wayne Cancer Center, the University
of Louisville, M. D. Anderson and University Hospitals –
Case Western Reserve.
Year-to-date corporate development milestones achieved are:
Received renewal of gamma device distribution agreement with Ethicon
Endo-Surgery through December 2008
Completed Lymphoseek regulatory submission of CMC response
Received FDA clearance to commence patient enrollment in Phase 2
clinical study
Received first commercial production of Quantix devices from U.S.
based contract manufacturer
Completed Investigational New Drug amendment submission for RIGScan®
CR
Reviewed Phase 2 Lymphoseek protocol and clinical program with
clinical investigators at Society of Surgical Oncology meeting
Completed agreement with ESTECH, Inc. for distribution of the
Quantix/OR in the U.S. and Europe
Commenced Phase 2 Lymphoseek clinical study with cGMP produced drug
Introduced Bluetooth wireless gamma detection probe at the recent
American College of Surgeons meeting and received purchase commitment
from primary marketing partner
Neoprobe’s President and CEO, David Bupp, and
Vice President and CFO, Brent Larson, will provide a business update and
discuss the company’s third quarter 2006
results via a conference call scheduled for 10:00 AM EST, Friday,
November 3, 2006. The conference call can be accessed as follows:
Neoprobe is a biomedical company focused on enhancing patient care and
improving patient outcome by meeting the critical intraoperative
diagnostic information needs of physicians and therapeutic treatment
needs of patients. Neoprobe currently markets the neo2000®
line of gamma detection systems that are widely used by cancer surgeons
and is commercializing the Quantix®
line of blood flow measurement products developed by its subsidiary,
Cardiosonix Ltd. In addition, Neoprobe holds significant interests in
the development of related biomedical systems and radiopharmaceutical
agents including Lymphoseek®
and RIGScan® CR.
Neoprobe’s subsidiary, Cira Biosciences,
Inc., is also advancing a patient-specific cellular therapy technology
platform called ACT. Neoprobe’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. www.neoprobe.com
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, anticipated clinical and
regulatory pathways, and markets for the Company’s
products are forward-looking statementsThe 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
products, 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.
The Bluetooth® word mark and logos are owned
by the Bluetooth SIG, Inc. and any use of such marks by Neoprobe
Corporation is under license. Other trademarks and trade names are those
of their respective owners.
