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BDSI, HAUP, DNDN, NEGS, CGFIA, APCX
Our Stocks to Watch today include BioDelivery Sciences International Inc. (NASDAQ: BDSI), Hauppauge Digital Inc. (NASDAQ: HAUP), Dendreon Corp. (NASDAQ: DNDN), NX Global Inc. (OTCBB: NEGS), Colorado Goldfields Inc. (OTC: CGFIA) and AppTech Corp. (OTC: APCX).
STOCKS TO WATCH
BIODELIVERY SCIENCES INTERNATIONAL (NASDAQ: BDSI)
"Up 42.70% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/BDSI.php
BioDelivery Sciences International is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology.
BDSI News:
January 6 - BioDelivery Sciences Announces Worldwide License and Development Agreement with Endo Pharmaceuticals for BEMA Buprenorphine
BDSI to receive up to $180 million plus royalties
BDSI management to hold conference call on Friday, Jan. 6, 2012, at 8:30 A.M. EST
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced the signing of a worldwide license and development agreement with Endo Pharmaceuticals (NASDAQ: ENDP) for the exclusive rights to develop and commercialize BEMA Buprenorphine for the treatment of chronic pain. BEMA Buprenorphine utilizes BDSI's patented and proven BioErodible MucoAdhesive (BEMA) technology to deliver the opioid analgesic buprenorphine.
In aggregate, the agreement is worth up to $180 million to BDSI if all milestones are met, which includes an upfront payment of $30 million , as well as intellectual property, development, regulatory and commercial milestone payments. Additionally, BDSI will receive a tiered mid to upper teen royalty on U.S. net sales of BEMA Buprenorphine.
Financial terms of the agreement include:
* $30 million upfront payment to BDSI upon execution of the definitive agreement;
* $95 million in potential milestone payments based on achievement of pre-defined intellectual property, clinical development and regulatory events;
* $55 million in potential sales milestones upon achievement of designated sales levels; and
* Tiered, mid to upper teen royalty on U.S. net sales.
Under terms of the agreement, Endo will be responsible for the manufacturing, distribution, marketing and sales of BEMA Buprenorphine on a worldwide basis. Endo will commercialize BEMA Buprenorphine outside the U.S. through its own efforts or through regional partnerships. Both companies will collaborate on the planning and finalization of the Phase 3 clinical development program and regulatory strategy for BEMA Buprenorphine for chronic pain. BDSI will maintain responsibility for the conduct of planned clinical studies leading up to the submission of the New Drug Application (NDA). Endo will have the responsibility of submitting the NDA and managing the interactions with FDA.
"We could not be more pleased to enter into this significant partnership with a company that has the financial strength, market presence and focus in pain management as Endo," said Dr. Mark A. Sirgo , President and Chief Executive Officer of BDSI. "As we considered the ideal commercial partner for BDSI's most significant asset, we sought to balance the financial benefits of the transaction with a company that had a real need for a product with the potential of BEMA Buprenorphine along with solid experience and commitment to the pain category. Endo is one of the most highly regarded and recognized companies in the area of pain management, and they continue to demonstrate their ability to excel in this category."
"Endo is committed to serving as an integrated solutions provider for the development and commercialization of products focused on the management of pain," said Dave Holveck , President and Chief Executive Officer of Endo. "The addition of BEMA Buprenorphine will broaden Endo's portfolio of pain therapeutics, allowing us to offer an integrated suite of products that currently includes Opana ER, Voltaren Gel and Lidoderm, as well as a broad range of generic pain products. We look forward to working closely with BDSI on the development of this important asset."
HAUPPAUGE DIGITAL INCORPORATED (NASDAQ: HAUP)
"Up 35.96% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/HAUP.php
Hauppauge Digital Inc. (HAUP) is a developer of analog and digital television tuners and other products for the personal computer (PC) market. Through the Company's Hauppauge Computer Works Inc., Hauppauge Digital Europe Sarl and PCTV Systems Sarl subsidiaries, the Company designs, develops, manufactures and markets analog, digital and other types of television tuners and other devices that allow PC users to watch television on a PC screen in a resizable window. The Company's products also enable the recording of television shows to a PC's hard disk, receiving of digital television data transmissions and the display of digital media stored on a computer to a television set via a home network. The Company's products fall under three product categories: Analog television tuners, digital television tuners and combination analog plus digital television tuner products, and other non-television tuner products.
HAUP News:
December 28 - Hauppauge Digital Reports Fiscal 2011 Fourth Quarter and Year End Results
Hauppauge Digital Inc. (NASDAQ: HAUP), a leading developer of digital video TV and data broadcast receiver products for personal computers, today reported financial results for the fourth fiscal quarter and year ended September 30, 2011.
FOURTH QUARTER RESULTS
Net sales were $10.3 million for the fourth quarter of fiscal 2011 compared to $11.6 million reported for the previous year's fourth fiscal quarter.
The Company incurred a net loss of $2,075,730 for the fourth quarter of fiscal 2011 compared to a net loss of $1,524,352 for the fourth quarter of fiscal 2010. Net loss per share for the fourth quarter of fiscal 2011 was $0.21 on a basic and diluted basis, compared to a net loss per share of $0.15 on a basic and diluted basis for the fourth quarter of fiscal 2010.
FISCAL YEAR RESULTS
Net sales were $42.3 million for the fiscal year ended September 30, 2011 compared to $56.9 million reported for fiscal year ended September 30, 2010 .
The Company incurred a net loss of $5,849,072 for fiscal year ended September 30, 2011 compared to a net loss of $1,846,560 for the fiscal year ended September 30 , 2010. The results for the fiscal year ended September 30, 2010 reflected a reduction in accrued expenses fees of about $2.25 million for settlements and changes in estimates. Net loss per share for the fiscal year ended September 30, 2011 was $0.58 on a basic and diluted basis, compared to a net loss per share of $0.18 on a basic and diluted basis for the fiscal year ended September 30 , 2010.
DISCUSSION OF RESULTS
Ken Plotkin , Hauppauge 's Chief Executive Officer stated, "Fiscal 2011 was a challenging year for the Company. Sales into Europe , which historically has been our strongest region for our TV tuner products, slowed dramatically. The slowdown affected southern Europe , including Spain and Italy , but also included previously strong markets, such as Germany .
"In 2011, we began transitioning our product portfolio from lower-end TV tuner products to higher-end video recorder, video streaming and digital TV tuner products with the introduction of 'Colossus', a high definition video recorder, 'Broadway', our live TV streaming products for the iPad and iPhone, our HD-PVR Gaming Edition, and our WinTV-DCR-2650 dual tuner CableCARD receiver. The WinTV-DCR-2650 allows a PC user in the United States to connect to their digital cable TV signal and watch or record up to two programs at a time.
"We believe the repositioning of our product offerings will result in future benefits for the Company.
"In recognition of the impact of the sales transition, during the second half of fiscal 2011, the Company implemented an expense reduction plan in order to bring the overhead expense level more in line with our current sales. We have closed some offices and reduced personnel levels in other offices.
"The Company believes that the effect of this expense reduction plan coupled with the sales transition of our product portfolio will have a positive effect on our operations starting with the first quarter of fiscal 2012."
DENDREON CORPORATION (NASDAQ: DNDN)
"Up 12.34% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/DNDN.php
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon’s first product, PROVENGE® (sipuleucel-T), was approved by the U.S. Food and Drug Administration (FDA) in April 2010. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. The Company is headquartered in Seattle, Washington.
DNDN News:
January 5 - Dendreon Announces Fourth Quarter Revenues and Update on Commercialization
Company Reports Gross PROVENGE Revenues of Approximately $82M in Q4, Gross PROVENGE Revenues of Approximately $228M in 2011
Dendreon Corporation (NASDAQ: DNDN) announced revenue for the fourth quarter ended December 31, 2011, reporting gross product revenue of approximately $82 million. This represents approximately 25% growth over the third quarter ended September 30, 2011, and approximately 230% growth compared to the fourth quarter ended December 31, 2010. In addition, Dendreon reported full-year gross revenues from PROVENGE® (sipuleucel-T) sales of approximately $228 million.
“We are pleased with the progress we have made in the launch of PROVENGE, which – based on its first full year of revenues – places it as one of the top 10 product launches in oncology,” said Mitchell H. Gold, MD, president and chief executive officer.
In addition, Dendreon provided the following updates:
* At the end of the fourth quarter, completed in-servicing for more than 840 total sites, of which:
a) More than 590 sites have infused PROVENGE, which represents the greatest growth in infusing sites quarter over quarter; and
b) Approximately 615 sites have either infused the product or have their patients scheduled for their first PROVENGE regimen.
* Improved PROVENGE reimbursement landscape for customers and patients:
a) Reported average time to payment is less than 30 days for physicians, which is better than industry standard, reflecting an improved reimbursement landscape due to a national coverage decision and activation of a Q-code that accelerates electronic adjudication of claims.
b) The Centers for Medicare and Medicaid Services (CMS) updated their coverage policy to now cover the infusion costs associated with the administration of PROVENGE. With this decision, the coverage of PROVENGE is now consistent with all other infused biologics.
c) A recent analysis suggests that approximately 75% of patients had minimal or no out-of-pocket costs for PROVENGE.
“Given our results for the past two quarters, physician and patient interest in PROVENGE clearly continues to grow. We believe that the improved reimbursement landscape, along with our improved sales execution and physician education initiatives, are contributing to the increased use of PROVENGE in the community urology and oncology settings,” said Mitchell H. Gold, MD, president and chief executive officer. “We had a strong fourth quarter that exceeded our expectations. As we look to 2012, we expect modest quarter-over-quarter growth while we focus on bringing additional clinics on board and converting them into steady prescribers.”
“Importantly, we have sufficient cash-on-hand to meet our needs, and our focus operationally for 2012 is to reduce COGS across our manufacturing facilities to more efficiently produce PROVENGE for as many patients as possible,” said Gregory T. Schiffman, executive vice president and chief financial officer.
NX GLOBAL INCORPORATED (OTCBB: NEGS)
"Up 23.08% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/NEGS.php
NX Global, Inc. engages in renewable energy activities in the United States. It operates in three divisions: Renewable Energy Project Management, Renewable Energy Product Sales, and Green Internet Technologies. The Renewable Energy Project Management division provides project management and marketing services to solar/thermal, bio-fuels, and waste to energy project owners. Its projects include bio-fuel from algae and from pyrolisis of tires, pyrolisis of municipal solid waste to energy, and combination operations of solar/thermal and animal waste pyrolisis. The Renewable Energy Product Sales division markets products produced from the other divisions, such as algae oil for fuel and its biomass for nutraceutical and animal feed to recyclers and other businesses, as well as lighting and water systems for commercial structures. The Green Internet Technologies Service and Training division offers green social networking products and services, and training for new technology development and certification in the virtualization and cloud computing markets. The company was founded in 1995 and is based in Austin, Texas.
NEGS News:
October 27 - NX Global, Inc. Announces Corporate Action
NX Global, Inc. (OTCBB: NEGS) announced that a reverse split of its common stock 1:100 will be effective at the market open October 28, 2011 and trade under the symbol "NEGSD" for twenty business days before reverting to "NEGS."
The company also announced that a joint venture previously announced with the United Women's Football League was terminated by the company.
NX Global, Inc. is negotiating for joint ventures and acquisitions with "green" businesses and products. These agreements are expected to be completed in November.
COLORADO GOLDFIELDS INCORPORATED (OTCBB: CGFIA)
"Up 100.00% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/CGFIA.php
Colorado Goldfields Inc. is a Denver-based junior exploration and mining company primarily exploring for gold and silver. Our seasoned management team targets historic gold camps with strong potential for multiple deposit discoveries. Currently, our business model in Colorado provides an outstanding combination of former producing properties with excellent exploration and production potential and a currently inactive, modern, up to 700 ton per day capacity mill facility to allow for an attractive short-term production time frame. We expect that this strategic plan will allow Colorado Goldfields to reach its goal of profitability, potentially within the next 18 months.
CGFIA News:
December 21 - Colorado Goldfields Inc. Convenes Summit With Senior Consulting Engineering Team; Sets Final Design Completion Date of January 15, 2012
Colorado Goldfields Inc.'s (OTC: CGFIA) Special Consulting Engineer, Stephen C. Fearn recently talked with engineer Wayne Dale, who is completing the final piece of the Company's upcoming reclamation permit amendment submission to the Colorado Division of Reclamation, Ming and Safety ("Division").
Mr. Fearn: What work is required to complete the design of the Dry Stack Tailings Repository?
Mr. Dale: The Avalanche Study has been completed and with the completion of the Avalanche study new design considerations were identified which are now being addressed. We now need to finish the design of the containment system. With the completed design of the containment system we will address the issues necessary to assure the Division of the stability of the tailings repository during the different stages of tailings placement and for final site closure. This will be addressed by the results of the seismic study which is currently in progress. The last phase of the containment design will incorporate features in the embankment design to ensure protection from the 100 year flood event.
Mr. Fearn: What is the initial designed size and capacity of the dry stack repository?
Mr. Dale: The initial design capacity of the first cell is approximately 100,000 tons. The expected capacity of the first unit (cells 1 and 2) will be approximately 250,000 tons. The first cell will be approximately 200 feet wide and 500 feet long. The second cell will be approximately 200 feet wide and 400 feet long. After completion of cells 1 and 2, additional tailings will be placed into the volume between the two cells. This develops approximately 7 acres of the 35 acre repository site.
Mr. Fearn: Why is it important and what problems do we avoid by completing each of these items prior to submitting the permit amendment application?
Mr. Dale: The most important thing to do is submit the most complete and detailed Permit Amendment to the Division for their review. This will allow the Division to do a onetime comprehensive review of the amendment, rather than having to pass-through the entire submittal multiple times. This has been a common mistake in the past.
Mr. Fearn: What is the schedule for completion of these items and is their completion interdependent?
Mr. Dale: With the completion of the avalanche study, all inter-dependencies have been removed. We estimate that the final design for inclusion in the permit amendment application will be completed by January 15, 2012.
Mr. Fearn: How does providing a complete design to the Division of Reclamation, Mining and Safety with the Permit Amendment Application reduce the time required for Permit Approval?
Mr. Dale: One of the reasons that permitting can take so long (as we've seen with other operators in the area), is that designs are submitted on a conceptual level with references to "further detailed analysis later." All this does is slow the evaluation process. A one-time comprehensive review will eliminate multiple submittals, which are in the form of answers to "adequacy issues." Each one of those can add weeks to approval process. We are going to avoid that.
Mr. Fearn: How is the current dry stack design providing superior protection to the environment? And does it provide better utilization of the overall repository site than in the original proposed design?
Mr. Dale: The new design will demonstrate to the Division that Colorado Goldfields is concerned for the protection of the environment by: 1) Protecting the Animas River from the potential of an accidental spill and the resulting degradation of water quality by contaminants; 2) Protecting the construction site from precipitation on the tailings pile during placement of the tailings; and, 3) Placing a protective cap over the dry-stacked tailings at the completion of each major section of the repository, minimizing the additional work required for final reclamation when the milling process is completed and the site is closed. The new design will provide for better utilization of the site by increasing the individual cell capacity and reducing the number of individual cells. More site volume can be utilized for mill tailings disposal and less borrow material and construction time will be required in the construction of perimeter berms.
APPTECH CORPORATION (OTC: APCX)
"Up 100.00% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/APCX.php
AppTech Corp is developing mobile application market places serving emerging markets in Latin America, Brazil and the USA. AppTech is focused on multi-platform mobile apps designed to run on device operating systems such as Apple iPhone and Google's Android. In addition, through its wholly owned subsidiary, Oronoco Telecom, AppTech is working on securing agreements with top communication companies in Central America, South America and The Caribbean.
APCX News:
December 1 - AppTech Announces Appointment of New CFO
AppTech Corp. (OTC: APCX), a leading publicly-held, live mobile video apps distributor, announced that Mr. Carlos Eduardo Cerizze has been appointed as the company's new Chief Financial Officer (CFO). Prior to joining AppTech, Mr. Cerizze was Prudential's MIIP Industrial Fund Treasurer followed by a tenure as General Manager-Real Estate for PatioMix, a leading Brazilian shopping mall developer.
Mr. Cerizze brings to AppTech vast experience in financial management, having been responsible for investments in industrial assets in select Mexican and Brazilian markets as well as attracting significant financial resources in conjunction with institutional investors.
"Carlos is solidly committed to enhancing AppTech's relations with the professional investment community while the company prepares its financial structure for rapid growth," commented AppTech's CEO, Elias Rocha . Mr. Cerizze added: "AppTech has a unique capacity to provide premium mobile content distribution together with proprietary, state-of-the-art, live mobile video technology to the entire Latin American market. Our first and very focused goal is to seek capital appreciation by increasing revenues through our media partnerships."
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