Neoprobe Announces First Quarter Results; Provides Business Update.Business Editors/Health/Medical Writers DUBLIN Dublin, city, Republic of Ireland Dublin, Irish Baile Átha Cliath, county borough (1991 pop. 915,516), Leinster, capital of the Republic of Ireland, on Dublin Bay at the mouth of the Liffey River. , Ohio--(BUSINESS WIRE)--May 12, 2004 Neoprobe Corporation (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :NEOP NEOP Neoprobe Corporation (stock symbol) NEOP Near Earth Object Program NEOP New England Order of Protection NEOP Nuclear Explosive Operating Procedure ), a diversified diversified (di·verˑ·s developer of innovative oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. and cardiovascular cardiovascular /car·dio·vas·cu·lar/ (-vas´ku-ler) pertaining to the heart and blood vessels. car·di·o·vas·cu·lar adj. Abbr. surgical and diagnostic products, today announced consolidated con·sol·i·date v. con·sol·i·dat·ed, con·sol·i·dat·ing, con·sol·i·dates v.tr. 1. To unite into one system or whole; combine: operating results for the first quarter of 2004. First quarter results included revenues of $1.4 million compared to $1.5 million for the first quarter of 2003. In addition, Neoprobe reported a net loss of $589,000 or $0.01 per share compared to a loss of $479,000 or $0.01 per share for the comparable period in 2003. Total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. were $1.4 million for the first quarter of 2004 compared to $1.2 million for the first quarter of 2003. David Bupp, Neoprobe's President & CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. said, "Our first quarter revenue was impacted by delays in the transfer of manufacturing of our neo NEO Abbreviation for nonequity options, which are options contracts on foreign currencies, debt issues, commodities, and stock indexes. 2000(R) gamma detection device to our new contract manufacturer that resulted in our accumulating backorders to our primary distributor of over $125,000 at March 31. If we had not been in a backorder Backorder is a distribution term that refers to the status of items on a purchase order in the event that some or all of the inventory required to fulfill the order is out of stock. position, which has since been corrected, our gamma device revenue would have been consistent with last year as expected. In addition, recent design improvements to the neo2000 have already contributed to an increase in gross margins on device sales to 56% of net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight compared to 36% of net sales in the prior year." "Revenue from our blood flow line has been lower than planned so far this year," Bupp continued. "The feedback we are receiving from clinicians following marketing clearance of our lead blood flow product, the Quantix/OR(TM), has been gratifying grat·i·fy tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies 1. To please or satisfy: His achievement gratified his father. See Synonyms at please. 2. . These early clinical exposures have also brought suggestions for product enhancements that we believe will stimulate a demand from blood flow measurement practitioners and expand our market by attracting surgeons not presently using blood flow measurement technology. We have already initiated efforts to implement the improvements to respond to the suggestions, the first of which will be completed during the second quarter. The Quantix/OR has gained attention in the last four months through two major cardiovascular and vascular vascular /vas·cu·lar/ (vas´ku-ler) 1. pertaining to vessels, particularly blood vessels. 2. indicative of a copious blood supply. vas·cu·lar adj. tradeshows and we have now completed training seven vascular-specific professional distributor sales teams covering 20 states in the U.S. We are working with additional sales teams that cover an incremental Additional or increased growth, bulk, quantity, number, or value; enlarged. Incremental cost is additional or increased cost of an item or service apart from its actual cost. 13 states and are identifying additional representatives to cover the remaining states. We are particularly encouraged by the willingness of North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. and European European emanating from or pertaining to Europe. European bat lyssavirus see lyssavirus. European beech tree fagussylvaticus. European blastomycosis see cryptococcosis. thought leaders to continue their evaluation of the product as these exciting product improvements are implemented." Operating expenses during the quarter increased over the prior year due primarily to development efforts in three areas. First, we reinitiated our RIGS RIGS Regionally Important Geological Site RIGS Radio Immuno Guided Surgery RIGS Reconnaissance/Intelligence Ground Systems (R) research efforts and continued to move forward with development of Lymphoseek(TM) (approximately $90,000). Second, we completed final development activities related to an updated version of our neo2000 system (approximately $55,000), and finally, we commenced certain product refinement activities related to the Quantix/OR (approximately $65,000). Bupp continued, "We believe our investments in support of the development of Lymphoseek and RIGS will yield significant future rewards for Neoprobe and complement our successful gamma device products. In addition, we remain positive about the outlook for our Quantix(R) blood flow devices and believe the proposed refinements are primarily user interface in nature and do not detract from detract from verb 1. lessen, reduce, diminish, lower, take away from, derogate, devaluate << OPPOSITE enhance verb 2. the overall value we see in the underlying ADBF ADBF Asian Dragon Boat Federation ADBF Adaptive Digital Beamforming (TM) technology platform." Year-to-date Year-to-date (YTD) The period beginning at the start of the calendar year up to the current date. milestones:
-- RIGS development process reactivated through discussions with
FDA
During the first quarter, we prepared for the April 15th
meeting with FDA to determine the feasibility of reactivating
the RIGS development program. The April 15th meeting was very
helpful from a number of aspects: We confirmed that the RIGS
biologic license application (BLA) remains active and open. We
believe this will improve both the cost effectiveness and
timeliness of future regulatory submissions for RIGScan(R)
CR49. Additionally, FDA preliminarily confirmed that the BLA
may be applicable to the general colorectal population; and
not just the recurrent colorectal market as applied for in
1996. Applicability to a general colorectal population could
result in a greater market potential for the product than if
applicable to just the recurrent population. During the
meeting, FDA indicated that they would consider possible
diagnostic/prognostic indications for RIGScan CR49 and that
survival data from one of Neoprobe's earlier Phase III studies
could be supportive of a prognostic indication. Neoprobe
believes approval for a diagnostic indication prior to the
submission of additional prognostic data from a new trial
could positively impact the approval timeline for RIGScan
CR49. Neoprobe is working on the development of clinical
protocols covering both the diagnostic and prognostic
indications for RIGScan CR49. We plan to submit these
protocols for review by FDA during the second quarter. To
support the protocol development, we have engaged some of the
leading surgical oncologists in the United States and Europe
to work with us in the development of the RIGScan CR49
clinical plan. We will be making further announcements on
these activities in the near future. The April 15th meeting
with FDA was an important event in the re-activation of the
RIGS program. Further discussion with FDA is expected and it
is possible that the regulatory pathway may evolve as Neoprobe
seeks to reach a consensus with the agency on the reactivation
of the RIGS filing.
-- Lymphoseek development
We continued to prepare our IND for submission to FDA. Efforts
during the quarter primarily involved the identification of a
suitable contract manufacturing facility for production of
commercial grade product for use in the protocol.
-- Second U.S. patent issued covering the Quantix ADBF technology
During the first quarter, the second ADBF patent was issued in
the United States providing further coverage of the critical
aspects of the Quantix products. In addition, we have received
favorable input from European patent reviewers on patent
applications covering the ADBF technology in the European
Union.
-- Gross margins on net device sales increased significantly over
the prior year
The investment of Neoprobe in the gamma device product
provided immediate return during the first quarter with the
improvement of gross margins on net device sales for these
products. While delays in the transfer of manufacturing of the
neo2000 caused Neoprobe to miss its sales target for the
quarter, design modifications and lower manufacturing costs
increased our gross margin on net sales of devices increased
significantly from 36% last year to 56% this year. Deliveries
of the gamma product to our primary distributor are back on
schedule and we expect the improvement in margins to continue.
-- Extension of gamma marketing agreement through December 2006
The marketing agreement for Neoprobe's gamma products was
extended through December 2006. The agreement extension
affords Neoprobe access to one of the premier medical sales
organizations with a expanding global reach. In cooperation
with the marketing partner, we continue to work on product
innovations to maintain Neoprobe's leadership position in the
gamma product arena.
-- Expansion of Quantix product sales organization and
thought-leader network
During the first quarter, Neoprobe began the training of a
network of independent medical sales organizations concerning
the Quantix products. Our marketing efforts have been
concentrated on the Quantix/OR device that we believe will be
the flagship product of the Quantix family of products. In
addition to training the sales organizations, Neoprobe
continued to work with cardiovascular thought-leaders
regarding the evaluation of the Quantix/OR and Quantix/ND(TM)
systems. The feedback we received confirmed the desire for
certain product improvements, such as changes to the probe
configuration, that were underway but the clinician feedback
emphasized their urgency. We expect to have initial product
modifications completed by the end of the second quarter.
During the coming months we expect to further expand our sales
coverage through additional external organizations in
preparation for the introduction of these product
improvements.
-- Raised $1.9 million in equity financing
The addition of $1.9 million in capital provides Neoprobe with
a strong capital structure to accomplish our near-term goals.
Approximately $600,000 was obtained through the exercise of
warrants issued in November of 2003 with the private equity
placement. In addition, approximately $1.3 million was raised
through the issuance of common shares to Fusion Capital at an
average share price of $0.60.
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 intraoperative /in·tra·op·er·a·tive/ (-op´er-ah-tiv?) occurring during a surgical operation. intraoperative occurring during a surgical operation. lymphatic lymphatic /lym·phat·ic/ (lim-fat´ik) 1. pertaining to lymph or to a lymphatic vessel. 2. a lymphatic vessel. lym·phat·ic adj. 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 bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. systems and agents including Lymphoseek(TM) and RIGScan(R) CR49. Lymphoseek is an investigational drug being developed as a lymphatic tracing agent in conjunction with the University of California, San Diego UCSD is consistently ranked among the top ten public universities for undergraduate education in the United States by U.S. News & World Report.[3] It is a Public Ivy. [1] For graduate studies, most of UCSD's Ph.D. . 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 1. real-time - Describes an application which requires a program to respond to stimuli within some small upper limit of response time (typically milli- or microseconds). Process control at a chemical plant is the classic example. information to locate tumor tumor: see neoplasm. deposits that may not be detectable by conventional methods. Before surgery, a cancer patient is injected in·ject·ed adj. 1. Of or relating to a substance introduced into the body. 2. Of or relating to a blood vessel that is visibly distended with blood. injected 1. introduced by injection. 2. congested. with one of the targeting agents, which circulates throughout the patient's body and binds specifically to cancer cell antigens Antigens Markers on the outside of such organisms as bacteria and viruses, which allow antibodies to recognize foreign invaders. Mentioned in: Measles, Q Fever, Severe Combined Immunodeficiency or receptors. Concentrations of the targeting agent are then located during surgery by the Company's gamma-detection instrument, which emits an audible A protected MP3 file format from the Audible.com audio download service. See Audible.com. 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 synergistic /syn·er·gis·tic/ (sin?er-jis´tik) 1. acting together. 2. enhancing the effect of another force or agent. syn·er·gis·tic adj. 1. 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 forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. . The words "believe," "expect," "anticipate," "estimate," "project," and similar expressions identify forward-looking statements that speak only as of the date hereof here·of adv. Of this. hereof Adverb Formal or law of or concerning this Adv. 1. hereof - of or concerning this; "the twigs hereof are physic" . 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 operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. , uncertainty of market acceptance of its product, reliance on third party manufacturers, accumulated ac·cu·mu·late v. ac·cu·mu·lat·ed, ac·cu·mu·lat·ing, ac·cu·mu·lates v.tr. To gather or pile up; amass. See Synonyms at gather. v.intr. To mount up; increase. 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 reg·u·late tr.v. reg·u·lat·ed, reg·u·lat·ing, reg·u·lates 1. To control or direct according to rule, principle, or law. 2. 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
March 31, December 31,
2004 2003
(unaudited)
------------ ------------
Assets:
Cash and cash equivalents $ 3,390,284 $ 1,588,760
Other current assets 2,127,005 2,462,575
Intangible assets, net 2,833,674 2,935,515
Other non-current assets 404,649 398,192
------------ ------------
Total assets $ 8,755,612 $ 7,385,042
============ ============
Liabilities and stockholders' equity:
Current liabilities, excluding deferred
revenue $ 728,779 $ 654,341
Deferred revenue 727,091 955,587
Other liabilities 160,834 516,169
Stockholders' equity 7,138,908 5,258,945
------------ ------------
Total liabilities and stockholders' equity $ 8,755,612 $ 7,385,042
============ ============
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended
March 31, March 31,
2004 2003
(unaudited) (unaudited)
------------ ------------
Revenues:
Net sales $ 1,225,617 $ 1,303,646
License revenue and other 200,000 235,390
------------ ------------
Total revenues 1,425,617 1,539,036
------------ ------------
Cost of goods sold 540,142 839,062
------------ ------------
Gross profit 885,475 699,974
------------ ------------
Operating expenses:
Research and development 583,100 418,769
Selling, general and administrative 813,393 754,083
------------ ------------
Total operating expenses 1,396,493 1,172,852
------------ ------------
Loss from operations (511,018) (472,878)
Other expenses, net (77,559) (5,690)
------------ ------------
Net loss $ (588,577) $ (478,568)
============ ============
Loss per common share:
Basic $ (0.01) $ (0.01)
Diluted $ (0.01) $ (0.01)
Weighted average shares outstanding:
Basic 53,049,534 38,258,231
Diluted 53,049,534 38,258,231
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