3SOF

Profile: 

Neoprobe Corp.
425 Metro Place North
Suite 300
Dublin, OH 43017
United States - Map
Phone: 614-793-7500
Fax: 614-793-7520
Website: http://www.neoprobe.com

Details   
Index Membership: N/A
Sector: Healthcare
Industry: Medical Appliances & Equipment
Full Time Employees: 28


Business Summary   

Neoprobe Corporation, a biomedical company, engages in the development and commercialization of surgical and diagnostic products that enhance patient care by meeting the decision making needs of physicians in the United States and internationally. The company primarily offers a line of gamma radiation detection equipment used in the application of sentinel lymph node biopsy. Its product line includes neoprobe GDS gamma detection system, a control unit that is software-upgradeable; and gamma detection probes capable of detecting higher energy isotopes, such as fludeoxyglucoses that are frequently used in connection with positron emission tomography scans. The company also holds developmental and/or intellectual property rights related to Lymphoseek, which is intended to be used in determining the spread of certain solid tumor cancers into the lymphatic system; and the RIGScan CR intended to help surgeons locate cancerous or disease involved tissue during colorectal cancer surgeries. Neoprobe Corporation has a biopharmaceutical development and supply agreement with Laureate Pharma, Inc. to support the initial evaluation of the viability of the CC49 master working cell bank, as well as the initial steps in re-validating the commercial production process for the biologic agent used in RIGScan CR.; and collaboration agreement with Phylogeny, Inc. to develop head and neck cancer detection technology. The company was founded in 1983 and is based in Dublin, Ohio.

Business Overview

BRIEF: For the nine months ended 30 September 2010, Neoprobe Corporation's revenues increased 6% to $7.5M. Net loss from continuing operations applicable to Common increased 49% to $56M. Revenues reflect an increase in sales from Oncology Devices segment. Net loss was offset by a rise in selling, general & administrative costs, higher research & development expenses, lower interest income and increased loss on extinguishment of debt. http://www.neoprobe.com/

If You are in it...Take some profits.
Earnings in a couple of weeks...look to get back in on a pullback.
Great long term potential here !

•Neoprobe Corporation (NEOP.OB) – A total of 411,185 shares were purchased during 2010 by insiders, increasing their stake to 13% owned. The company is up 18.45% year-to-date, and it all comes in anticipation as its blockbuster product, Lymphoseek, a "first-in-class" radiopharmaceutical designed to identify lymphatic tissue and support intra-operative biopsies during solid tumor cancer surgeries, is expected to present additional requested data from Phase 3 clinical trials during first quarter 2011. A projected $370 million dollar market is estimated by experts for Lymphoseek. For more information on Neoprobe, view our Seeking Alpha article on Neoprobe here.


Day's Range: 2.81 - 3.05
52wk Range: 1.42 - 3.05
Volume: 1,441,752
Avg Vol (3m): 347,238
Market Cap: 232.32M
P/E (ttm): N/A
EPS (ttm): -0.70
Div & Yield: N/A (N/A)

Technicals
Record Price High

Last Price Quote is:
22.13%above 13-day EMA
37.83%above 50-day EMA
RS Rating: N/A  

An Interview With The President Of The Neoprobe Corporation: David C. Bupp (NEOP)

On Tuesday January 25, 2011, 7:42 am EST
67 WALL STREET, New York - January 25, 2011 - The Wall Street Transcript has just published its Medical Devices Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.

Topics covered: Regulatory Hurdles and Health Care Reform - Pricing Pressures in the Medtech Industry - Life Science Tools' Outperformance in Industrial End Markets - Investment in Genomics Research - New Product Cycles in the Cardiovascular Space

Companies include: Boston Scientific (BSX); Abbott (ABT); Accuray (ARAY); Alimera Sciences (ALIM); Alphatec (ATEC); Axis-Shield (ASD.L); Baxter (BAX); CareFusion (CFN); Covidien (COV); Dionex (DNEX); Dynatronics (DYNT); Edwards Lifesciences (EW); Hologic (HOLX); Illumina (ILMN); Insulet (PODD); J&J (JNJ); Medtronic (MDT); Neoprobe (NEOP); NewCardio (NWCI); NuVasive (NUVA); NxStage Medical (NXTM); Orthofix (OFIX); Palomar (PMTI); Patient Safety Technologies (PSTX); St. Jude (STJ); Stryker (SYK); Thermo Fisher (TMO); Varian Medical (VAR); Waters (WAT); Wright Medical (WMGI); ZOLL Medical (ZOLL); Zimmer (ZMH).

In the following brief excerpt from just one of the many in-depth interviews in this extensive report, the President of Neoprobe Corporation discusses the outlook for his company for investors.

David C. Bupp has served as President and a Director of Neoprobe Corporation since August 1992 and as Chief Executive Officer since February 1998. From August 1992 to May 1993, Mr. Bupp served as the company's Treasurer. In addition to the foregoing positions, from December 1991 to August 1992, he was Acting President, Executive Vice President, Chief Operating Officer and Treasurer. From December 1989 to December 1991, Mr. Bupp was Vice President, Finance and Chief Financial Officer.

From 1982 to December 1989, Mr. Bupp was Senior Vice President, Regional Manager for AmeriTrust Company National Association, a nationally chartered bank holding company, where he was in charge of commercial banking operations throughout Central Ohio. Mr. Bupp has a B.A. degree in economics from Ohio Wesleyan University. He also completed a course of study at Stonier Graduate School of Banking at Rutgers University.

TWST: Please start out with an overview of Neoprobe, your history and your activities.

Mr. Bupp: Neoprobe (NEOP) is a biomedical company. We have an existing market-leading gamma detection device product, which is commercialized on a global basis and used in a cancer staging procedure called lymphatic mapping. That product generates for us a little bit north of $10 million a year in revenue at 70% gross margin.

We also have a radiopharmaceutical product that is also being used in lymphatic mapping that has completed one successful Phase III trial. A second Phase III trial is ramping up, and we would expect late first quarter of this year or early in the second quarter to be filing an NDA for that product to be used in lymphatic mapping.

TWST: Would you define for us the markets you're targeting, as well as a snapshot of your RIGS technology?

Mr. Bupp: The gamma detection device and the radiopharmaceutical product that we call Lymphoseek is targeted for the lymphatic mapping market, which is a cancer staging procedure for solid tumor cancers. The gamma device business is probably a market of $20 million to $25 million on an annual basis. The radiopharmaceutical market for lymphatic mapping is approaching about $450 million on a global basis, and this is the product Lymphoseek that we expect to have in registration during the first half of this year.

The RIGS technology is a third product, which is again used in surgical oncology. It is designed to help the cancer surgeon do a more complete surgical resection of patients with either colorectal cancer or with ovarian endometrial cancer, and the product uses a radiolabeled tumor-specific antibody. We are in the process of reactivating the clinical program for this product in both the U.S. and in Europe, and expect during this quarter to hold a meeting with FDA to have discussions regarding the scope of a Phase III clinical program for the RIGScan product. The product market, because of the incidence rate of both colorectal cancer and ovarian cancer on a global basis, has the potential to be a $3 billion-a-year product.

TWST: Last month the FDA granted you an IND for your RIGS Program. What does this RIG technology mean overall for cancer research, or is it strictly limited to colorectal cancer efforts?

Mr. Bupp: It depends upon the targeting agent. The current antibody that we are using, which targets the tumor-associated glycoprotein, or TAG-72 antigen, is produced by colorectal cancers and by ovarian cancers. But any solid tumors would benefit from the ability to do a more complete surgical resection, and unfortunately surgeons really only have the ability to remove what they can see or feel. And so if we can find other targeting agents for breast cancer, or potentially prostate cancer, there may be RIGS applications in those fields as well.

TWST: What trends are we seeing in gamma detection technology? What are the most significant trends, developments and changes you anticipate over the next several years?

The Wall Street Transcript is a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs and research analysts. This special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online .

The Wall Street Transcript does not endorse the views of any interviewees nor does it make stock recommendations.

For Information on subscribing to The Wall Street Transcript, please call 800/246-7673

Pending Neoprobe Catalysts Will Shape 2011...

Transformational pending catalysts at Neoprobe Corporation (NEOP.OB) will dictate where this stock goes in 2011. We are expecting positive news on several fronts over the next few months. Most importantly, Neoprobe is expected to announce top-line results from their Phase 3 trial using Lymphoseek in breast cancer and melanoma; this is data needed in order to file their NDA with the FDA (expected soon after the data release). They are also still awaiting news about a potential uplisting to the AMEX. These are critical catalysts for the future of NEOP, which should help determine how 2011 is going to unfold.

The most important catalyst to their future is the expected announcement of top‐line safety and efficacy data from their Lymphoseek Breast & Melanoma (NEO3-09) superiority trial. Once we hear about the completion of the study, we should expect the results soon thereafter. Based on the comments made by David Bupp (CEO of Neoprobe) at their analyst day, NEO3-09 results are expected sometime in early Q1. NEO3-09, was initially designed to support post-marketing labeling for Lymphoseek after the approval of initial product labeling in the NDA and show superiority over currently used dyes. Originally, they were going to submit the NDA in 4Q 2010, but the FDA wanted them to include the data from this trial as a part of their submission. They hope to get a priority 6-month review for Lymphoseek and file sometime at the end of Q1 or beginning of Q2.

The inclusion of NEO3-09 clinical data provides them with more robust data and the opportunity for commercial launch of Lymphoseek with enhanced product labeling. In the 3Q 2010 conference call, CEO David Bupp commented that the performance in NEO3-09 (Superiority trial) remained consistent with the results of the successfully completed NEO3-05 trial (Breast & Melanoma trial). It is an open-label study, so Neoprobe should have a very good idea how things are going. Full data will be out in early March at the Society of Surgical Oncology meeting.

Lymphoseek (Technetium Tc99m DTPA-mannosyl-dextran) is a proprietary radioactive lymphatic mapping targeting agent. Essentially, Lymphoseek is designed to identify sentinel lymph nodes that may be predictive of determining whether a patient's cancer has spread into the lymphatic system. They have already run a very successful Phase 3 trial in melanoma and breast cancer, in which Lymphoseek also has demonstrated superior site clearance and nodal binding characteristics, increased reliability, and a pain-free injection. Their Phase III breast and melanoma cancer trial results were 97% accurate with a 0% false-negative. They have begun a trial in head and neck cancer for post-marketing claims. They estimate the market for Lymphoseek to be more than $450 million on a world-wide; this can obviously increase with additional claims and labeling.

Once Lymphoseek is approved, NEOP has a revenue sharing agreement with Cardinal Health (CAH) to market and distribute it. Cardinal Health is the dominant player in the radiopharmaceutical market, so they will be able to tap a vast portion of the U.S. market. The terms of the agreement are for a period of five years from the date of FDA approval, wherein Neoprobe will receive a 50% share of each patient dose sold. Lymphoseek appears to be exactly what this company needs in order to really boost revenues and support development of their RIGScan CR.

Their RIGScan CR is the future of the company and any updates on it's clinical development will be positives.The device originally came before the FDA in 1997. It's original Biologic License Application (BLA) was not approved in 1997, citing a lack of documentation quantifying the patient survival benefits. However, a retrospective survival study by Schneebaum et al. 2004, showed a very apparent survival advantage. The potential market for the RIGScan is roughly $2-3B, based on company's estimates.

NEOP's RIGScan CR is designed to identify and evaluate potentially tumor-associated tissue in patients with colon or rectal cancer. It is a monoclonal antibody-based radiopharmaceutical tracer that binds to metastatic tissue. It provides surgeons with real-time information used to locate tumor components not detectable by conventional methods, and assist in the more thorough removal of the potentially cancerous tissue. In November, they announced that the FDA had granted them a Type B pre-IND meeting to review its RIGS technology BLA. Dr. Mark Pykett, Neoprobe executive VP and chief development officer, said, "We see the RIGS technology as a potential game-changer in the diagnosis of colorectal and other solid-tumor cancers that have long been some of the most difficult to treat and deadly forms of cancer."

RIGS BLA response includes plans for new biologic manufacturing to support the pivotal studies, the design of a new prospective Phase III RIGS trial based on results of NEO2-14 Phase III study, which showed very positive diagnostic and patient outcome data. This prospective Phase III trial will evaluate the RIGS technology in subjects with primary or recurrent hepatic patients, as the RIGS technology had excellent previous clinical success in this patient population. They also intend to request the Phase III study review under the SPA provisions. Additionally, they hope to file the revised protocol with the EMEA after things have been squared away with the FDA, in order to unify the approach in both the U.S and Europe. The potential market for the RIGScan is roughly $2-3B, based on company's estimates.

NEOP recently began the process of uplisting to AMEX. This will be an ongoing process, but one would hope the sooner the better. The AMEX listing committee recently met on January 6th, so it is possible we could be hearing news this quarter. If they were to uplist, it would be an incredibly positive event, since it would increase liquidity and the availability for institutions to invest in them. It's been important that the stock has maintained the $2 price level, which is required to uplist to AMEX. They recently strengthened their books by adding $6M with four institutional investors for 1.5M shares each back in November. We encourage investors to look through the presentations at Neoprobe's Analyst Day, since they provide a great review of the company and timelines for the next 12 months. We expect 2011 to be a very interesting year over at Neoprobe.

updated chart look...