For Wednesday, March 11th
GNBT, SYMD, ODP, VSTN, C, RFMD
Our Stocks to Watch tomorrow include Generex Biotechnology Corp. (Nasdaq: GNBT), SyntheMed Inc. (OTCBB: SYMD), Office Depot Inc. (NYSE: ODP), Visteon Corp. (OTC: VSTN), Citigroup Inc. (NYSE: C) and RF Micro Devices Inc. (Nasdaq: RFMD).
GENEREX BIOTECHNOLOGY CORPORATION (NASDAQ: GNBT)
"Up 250.00% on Tuesday"
Generex is engaged in the research, development and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(tm) device. The Company's flagship product, oral insulin (Generex Oral-lyn™), which is available for sale in India and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world.
March 10 - Generex Biotechnology Announces Successful Phase III Study Data for Generex Oral-lyn™
Generex Biotechnology Corporation (Nasdaq: GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced positive results following the review of the Phase III data for the Company's flagship product, Generex Oral-lyn, a proprietary oral insulin spray product designed to replace prandial injections of insulin.
Generex, together with the Company's independent third party statistical and data monitoring consultants, will continue to monitor the ongoing pivotal Phase III Generex Oral-lyn study according to protocol and national/international ICH-GCPs. To date, more than 300 subjects have been enrolled in the study (with 60 subjects having achieved the requisite six-month treatment milestone) and the product's non-inferiority to injectable meal-time (prandial) insulin appears to be maintained. If the current positive trend is maintained, then a large reduction of required enrollment will suffice for formal verification of the non-inferiority hypothesis.
The current data also demonstrates that no significant Generex Oral-lyn drug-related “Adverse Events” or “Serious Adverse Events” have been reported, which also supports the current initiatives of the study.
“The current data and trends represent a critical milestone for the Company,” said Anna Gluskin, Generex's President and Chief Executive Officer. “These results are consistent with the results of our previous studies. This will allow us greater flexibility in our strategies for filing submissions with regulatory authorities in major global markets and other jurisdictions where applications are already in progress.”
The Company believes that Generex Oral-lyn will offer a safe, simple, fast, effective and pain-free alternative to prandial insulin injections which will improve patient compliance with therapeutic regimes thereby delaying the progress of diabetes and the onset of its myriad complications.
SYNTHEMED INCORPORATED (OTCBB: SYMD)
"Up 60.00% on Tuesday"
SyntheMed, Inc., a biomaterials company, engages in the development and commercialization of medical devices for therapeutic applications. It offers surgical implants designed to prevent or reduce the formation of adhesions/scar tissue following a range of surgical procedures. The company's lead product includes REPEL-CV, a bioresorbable film designed to be placed over the surface of the heart at the conclusion of surgery to reduce the formation of post-operative adhesions. SyntheMed offers products based on the proprietary, bioresorbable polymer technology. Its products also include REPEL-AFIB, which reduces the patient risk associated with atrial fibrillation; RESOLVE that prevents or reduces post-operative surgical adhesions in gynecological and general abdominal surgery; and RELIEVE for preventing or reducing post-operative surgical adhesions in orthopedic and spinal surgery. The company, formerly known as Life Medical Sciences, Inc., was founded in 1990 and is headquartered in Iselin, New Jersey.
March 9 -
FDA Approves SyntheMed's REPEL-CV® Adhesion Barrier for Use in Pediatric Cardiac Surgery
SyntheMed, Inc. (OTCBB: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion products, announced that the U.S. Food and Drug Administration (FDA) has approved the Pre-market Approval (PMA) application for REPEL-CV® Adhesion Barrier for use in pediatric cardiac surgery patients. REPEL-CV is a bioresorbable film designed to be placed over the surface of the heart at the conclusion of an open-heart surgical procedure to reduce the formation of post-operative adhesions (scar tissue).
"The FDA approval of REPEL-CV as the first anti-adhesion product for use in cardiac surgery marks a major milestone for our company," stated Robert P. Hickey, President and Chief Executive Officer, SyntheMed, Inc. "We now look forward to providing US-based cardiac surgeons with a means of reducing the risks to which their pediatric patients are routinely exposed during secondary open-heart surgical procedures. We are engaged in discussions with FDA personnel to define the clinical data required to expand the use of REPEL-CV to include adult cardiac surgery patients."
REPEL-CV will be marketed in the United States through a direct sales force comprised of both company and independent sales representatives. REPEL-CV has CE Mark approval for use in all cardiac surgical patients and is currently marketed through a network of independent distributors in the European Union and in several Southeast Asian countries.
ABOUT CARDIAC ADHESIONS
Adhesions, or scar tissue, occur after virtually all open-heart surgical procedures, often resulting in the heart becoming attached to the sternum and other surrounding tissue surfaces. The presence of adhesions represents a prevalent and serious complication in secondary surgical procedures, increasing the length, cost and risk of the surgical procedure.
REPEL-CV is a bioresorbable adhesion barrier film designed to be placed over the surface of the heart at the conclusion of an open-heart surgical procedure to reduce the severity of adhesions that form between the surface of the heart and adjacent tissue surfaces following the surgical procedure. REPEL-CV is designed to provide the therapeutic benefit and then degrade so that it is cleared from the surgical site. REPEL-CV represents the first in a series of anti-adhesion products under development that are based on the company's proprietary polymer technology.
In a randomized, controlled clinical trial conducted at 15 pediatric cardiac surgery centers throughout the United States, over 70% of the REPEL-CV treated patients were completely free of clinically-significant adhesions, the most severe grade of adhesions measured, as compared to less than 30% in the control patients. In the primary clinical endpoint assessment, the mean extent of clinically-significant adhesions in the control patients was 2.5 times greater than in the REPEL-CV treated patients.
OFFICE DEPOT INCORPORATED (NYSE: ODP)
"Up 55.93% on Tuesday"
Every day, Office Depot is Taking Care of Business for millions of customers around the globe. For the local corner store as well as Fortune 500 companies, Office Depot provides products and services to its customers through 1,713 worldwide retail stores, a dedicated sales force, top-rated catalogs and a $4.8 billion e-commerce operation. Office Depot has annual sales of approximately $14.5 billion, and employs about 43,000 associates around the world. The Company provides more office products and services to more customers in more countries than any other company, and currently sells to customers directly or through affiliates in 48 countries.
March 10 -
Office Depot to Participate in the Bank of America and Merrill Lynch Consumer Conference
Office Depot, Inc. (NYSE: ODP), a leading global provider of office products and services, announced that it will participate in the Bank of America and Merrill Lynch Consumer Conference in New York City on Wednesday, March 11, 2009.
Office Depot management plans to meet with investors to provide an update on the Company’s strategic business review and projected first quarter 2009 performance. The update will include the following information:
* Cash flow before financing activities is projected to be about $50 - $150 million positive in the first quarter, depending on the timing of certain liquidity initiatives.
* EBIT will be significantly better than fourth quarter 2008; tracking towards a loss of $30 - $40 million.
* Cash received as part of the liquidity initiatives total over $100 million to date in the first quarter and tracking towards $150 million for the first quarter.
* North American Retail sales comps in the first quarter to date are tracking slightly better than its fourth quarter performance.
* The six distribution facilities identified as part of the North American supply chain network consolidation will be closed by the end of the first quarter.
* The 112 North American Retail stores identified as part of the strategic review will be closed by the end of the first quarter.
* Accounts receivable and inventory valuation (availability) may be reduced by approximately $100 million in the first quarter (previous disclosures estimated $75 million) which would impact the asset-based loan facility borrowing base by the same amount.
VISTEON CORPORATION (OTC: VSTN)
"Up 61.54% on Tuesday"
Visteon Corporation is a leading global automotive supplier that designs, engineers and manufactures innovative climate, interior, electronic and lighting products for vehicle manufacturers, and also provides a range of products and services to aftermarket customers. With corporate offices in Van Buren Township, Mich. (U.S.); Shanghai, China; and Kerpen, Germany; the company has facilities in 27 countries and employs approximately 33,500 people.
March 5 -
Visteon Corporation Stock to Trade Over-the-Counter Under New Symbol
Visteon Corporation (OTC: VSTN) announced that its common stock will begin trading over-the-counter on the Pink Sheets on Friday, March 6, under the symbol “VSTN.” Trading information pertaining to VSTN can be found on most electronic financial portals and at www.pinksheets.com.
The move follows an announcement Wednesday by the New York Stock Exchange that Visteon common stock will be suspended from the NYSE at the end of trading today, based on an NYSE determination on low trading levels of the stock.
The company noted that while its stock is changing markets, shares are unaffected. Instead of trading on the NYSE, shares will be available for trading over-the-counter (OTC) on the Pink Sheets, a centralized quotation service that publishes quotes for OTC securities.
CITIGROUP INCORPORATED (NYSE: C)
"Up 38.10% on Tuesday"
Citigroup, the leading global financial services company, has approximately 200 million customer accounts and does business in more than 140 countries. Through its two operating units, Citicorp and Citi Holdings, Citi provides consumers, corporations, governments and institutions with a broad range of financial products and services, including consumer banking and credit, corporate and investment banking, securities brokerage, and wealth management.
March 9 -
CitiFX ProSM US Launches Web and Mobile Trading
Citigroup Inc. (NYSE: C) announced that it has introduced Web and Mobile versions of the CitiFX Pro margin FX trading platform. CitiFX Pro clients are now able to access their accounts and trade real-time via three state-of-the-art platforms: CitiFX Pro Trader, the current desktop version, CitiFX Pro Web and CitiFX Pro Mobile. Clients with Internet browser access can view streaming prices and charts for over 130 currency pairs and execute trades via CitiFX Pro Web, which can be launched without software installation.
Prospective clients can now try the Web platform via an innovative “Instant Demo”, which is available on www.citifxpro.com. The demo allows the user to experience a realistic FX trading environment using live prices within seconds without filling out online forms.
Through CitiFX Pro, small institutions and individuals can trade FX on a sophisticated online platform. Citi recently announced that CitiFX Pro clients would receive FDIC insurance on their entire US dollar account balances. Citi also offers its clients its award-winning research and FX market commentary free of charge. These features make the CitiFX Pro offering one of the most compelling trading products currently available for online FX traders.
“With the launch of Web and Mobile versions, CitiFX Pro clients will be able to access their accounts and trade anywhere, anytime. Along with our highly-rated proprietary research and market commentary, we hope to give our clients highly relevant tools to help them in their trading activity,” said Sanjay Madgavkar, Head of FX Margin Trading at Citi.
ABOUT CITIFX PRO
CitiFX Pro is an online foreign exchange trading platform formed in November 2007 in partnership with Saxo Bank, the Copenhagen-based online Bank. CitiFX Pro offers Citi’s individual and small institutional clients an opportunity to take full advantage of the world’s largest financial market with access to the same real time data and trading technology as institutional traders. CitiFX Pro is currently live in US and Asian markets and will be launched in additional regions in early 2009.
RF MICRO DEVICES INCORPORATED (NASDAQ: RFMD)
"Up 20.00% on Tuesday"
RF Micro Devices, Inc. is a global leader in the design and manufacture of high-performance semiconductor components. RFMD's products enable worldwide mobility, provide enhanced connectivity and support advanced functionality in the cellular handset, wireless infrastructure, wireless local area network (WLAN), CATV/broadband and aerospace and defense markets. RFMD is recognized for its diverse portfolio of semiconductor technologies and RF systems expertise and is a preferred supplier to the world's leading mobile device, customer premises and communications equipment providers. Headquartered in Greensboro, N.C., RFMD is an ISO 9001- and ISO 14001-certified manufacturer with worldwide engineering, design, sales and service facilities.
March 10 -
RFMD Highlights Improving Order Activity, Projects Increasing Cash Balance
RF Micro Devices, Inc. (Nasdaq: RFMD), a global leader in the design and manufacture of high-performance semiconductor components, provided updated financial information, including forecasts for the generation of cash in the March 2009 quarter and in RFMD's 2010 fiscal year, which begins March 29, 2009. The Company made the comments during a web-cast investor presentation yesterday at the Raymond James 30th Annual Institutional Investors Conference in Orlando, Florida.
During the conference, Dean Priddy, CFO and vice president of administration of RFMD, said RFMD is executing on its cash flow projections and currently expects to continue reducing its net debt in the March 2009 quarter. Priddy said RFMD currently forecasts it will have reduced its net debt by approximately $100 million in three quarters by the close of the March 2009 quarter. Additionally, Priddy reiterated the Company's free cash flow forecast of approximately $80 million - $120 million in RFMD's fiscal 2010.
Priddy also commented the Company has proactively responded to the reduced demand environment by significantly lowering breakeven points for cash generation and operating income.
RFMD's capital expenditures were approximately $5 million in the December 2008 quarter, and the Company expects capital expenditures to be less than $20 million in calendar 2009. By comparison, RFMD's capital expenditures were approximately $81 million in calendar 2008.
Also during the conference, Bob Van Buskirk, president of RFMD's Multi-Market Products Group (MPG), said RFMD is experiencing improved order activity from customers across multiple industries. Van Buskirk said RFMD had successfully decreased capital and operating expenses, reduced costs and rationalized its supply chain to match the current demand environment. RFMD expects significant leverage as demand continues to improve and as new product cycles continue to ramp.
RFMD will provide more detailed information about its March 2009 quarterly financial results in its quarterly earnings press release and its corresponding quarterly earnings conference call.