Radient Pharmaceuticals Corporation (NYSE Amex: RPC), a US-based vertically integrated pharmaceutical company, whose wholly-owned subsidiary AMDL Diagnostics, Inc. (ADI) announced today it 2010 Business Plan. This forecast is based upon the Company raising at least $2 million during the first half of 2010.
2010 OVERALL ADI SALES FORECAST 2010 QTR 1 QTR 2 QTR 3 QTR 4 TOTALS ---------- ---------- ---------- ---------- ---------- ONKO-SURE Test Kits $ 297K $ 621K $ 1.56M $ 2.01M $ 4.48M ---------- ---------- ---------- ---------- ---------- Onko-Care (U.S.) - $74K $ 745K $ 1.34M $ 2.13M ---------- ---------- ---------- ---------- ---------- Onko-Care (Asia) - - $ 298K $ 745K $ 1.04M ---------- ---------- ---------- ---------- ---------- Gross Sales $ 297K $ 695K $ 2.254M $ 3.795M $ 7.65M ---------- ---------- ---------- ---------- ---------- Op. Expenses ($740K) ($963K) ($1.099M) ($1.507M) ($4.306M) ---------- ---------- ---------- ---------- ---------- Net Profits ($543K) ($418K) $905K $2.288M $ 3.344M
2009 INAUGURAL SALES OF ONKO-SURE
2009 was the inaugural year for commercial sales of ADI's Onko-Sure cancer test. In 2009, ADI sold 1,005 Onko-Sure Test kits at an average price of US$270.00 per kit (FOB Tustin, California) providing US$266,00 in gross revenues. The Onko-Sure test kit manufacturing cost is approximately US$58.00 per kit, providing approximately an 81% gross profit margin per test kit sold, or US$207,000 in 2009. ADI's 2009 operating expenses were approximately US$969,219, providing ADI an operating loss of approximately (US$762,219). In 2009, we sold Onko-Sure kits in 10 countries through 9 separate distribution partners.
2010 NEXT-GEN ONKO-SURE TRIALS
During the first two quarters of 2010, we anticipate completing clinical testing on approximately 1,400 cancer patient blood serum samples in order to expand the relevancy of our next-gen version of Onko-Sure, by definitively proving that our current laboratory based next-gen version of Onko-Sure has the ability to detect multiple cancers in stage one growth phase. We also expect to commence a separate set of clinical testing that will provide data for a late 2010 510K FDA submission, seeking the marketing approval for our next-gen version of Onko-Sure. The stage one detection claim of the next-gen version of Onko-Sure is anticipated to dramatically enhance the marketability and sales of our test kits and the CLIA lab testing services beginning as early as the 3rd quarter of 2010.
2010 NEW CLINICAL STUDIES, MARKET RESEARCH REPORTS, AND NEW ADI-AUTHORED STUDIES
ADI has signed a collaboration agreement with the University of Chile cancer research team to share data and publish a new clinical study including Onko-Sure as a lung cancer screening tool. Additionally, negotiations are under way to enter into a collaborative agreement (Q1, 2010) with a key opinion leader at the Hadasah Medical Center in Israel to sponsor an indication or general cancer testing clinical study with Onko-Sure using extensive samples. The US publication of a new study by ADI scientific staff comparing the efficacy of Onko-Sure as a CRC monitoring tool with advantages over current tests is expected in Q1 2010. This new published study will support and accelerate the commercialization effort in the US, the world's number one IVD market. ADI also anticipates staff publication of another new study, during Q3 of 2010, covering the utility of Onko-Sure for lung cancer screening and treatment monitoring. ADI expects results (Q1 2010) of an INVIDA (invida.com) sponsored Frost & Sullivan market research report highlighting size and scope of healthcare market for Onko-Sure (both public and private) cancer testing in key Asia-Pacific territories. ADI is also in advanced negotiations to commission a study by Frost & Sullivan in the US that will provide valuable market data from key opinion leaders and clinical reference labs for the U.S. market. These critical clinical studies, white papers and market research are significant catalysts that are anticipated to lifting sales of our Onko-Sure test kits sales in 2010.
2010 ONKO-SURE KIT SALES SNAPSHOT
In 2010, ADI anticipates selling approximately 16,666 Onko-Sure Test kits at an average price of US$270.00 per kit (FOB Tustin, California) providing US$4.48 million in gross revenues. Continued quarterly sales growth significantly trending upward with quarterly kit sales as follows: Q-1: 1,100 Kits; Q-2: 2,300 Kits; Q-3: 5,800 Kits and Q-4: 7,460 Kits. The Onko-Sure test kit manufacturing cost is approximately US$58.00 per kit, providing approximately an 81% gross profit margin per test kit sold, or an anticipated US$3.62 million in 2010. ADI's 2010 operating expenses are anticipated to be approximately US$2.86 million, providing ADI an operating net profit of approximately US$1.62 million. In 2010, we plan to sell Onko-Sure kits in 14 separate markets and countries through at least 10 separate distribution partners.
NEW 2010 ONKO-SURE LAB TESTING SERVICES BUSINESSES
IN 2010, ADI will be expanding upon its current sales of Onko-Sure Test Kits with two new related business segments: Onko-Care CLIA Lab Testing Services (Tustin, California) and Onko-Care Lab International Testing Services (Asia-Pacific) in Hong Kong & Singapore. These two testing services businesses are anticipated to generate approximately US$2.75 million in sales and approximately US$570K in net earnings in 2010. These testing services will utilize approximately 439 Onko-Sure test kits in 2010.
ONKO-CARE CLIA TESTING SERVICES (U.S.)
The Onko-Care CLIA Lab Testing Services (Tustin, California) is anticipated to be launched by April 2010, this new Onko-Care cancer testing service will utilize the next-gen version of Onko-Sure that has been shown in our laboratory to have over 95% sensitivity & specificity. The anticipated 2010 sales are forecasted to be $2.31 million. The current pricing of this CLIA lab cancer testing service is expected to be priced at US$149.00 per test. This is equivalent to selling an Onko-Sure test kit for approximately US$6,258 per kit. Operating expenses are anticipated to be approximately US$44.00 per test providing a net profit of approximately $105.00 per test. It is also anticipated that there will be approximately US$250K spent on pre-development costs during the first two quarters. This business segment will be directly operated by ADI out of our Tustin California facilities. This testing service will utilize approximately 273 Onko-Sure test kits in 2010.
CLIA LAB TESTING SERVICE MARKETING
Our 2010 marketing will initially be focused upon physician endorsements that will be targeted at other physicians & patients primarily driven around web-based social networking outreach and the initial targeting of the California market that has a population of approximately 36 million people and over 1,300 oncologists, who currently have an average of approximately 2,000 patients per physician or a total of approximately 2.6 million patients who have been diagnosed with cancer.
CREATION OF A 501-C NON-PROFIT
In order to expand on the relevance and value of regular cancer testing, we plan on creating and support an independent 501-C Non-profit company that will focus on an outreach program of "Stay Healthy Get Tested."
ONKO-CARE LAB TESTING SERVICES (ASIA-PACIFIC)
The Onko-Care Lab International Testing Services (Asia-Pacific) in anticipated to commence operations in Hong Kong & Singapore by July 2010. This new international Onko-Care cancer testing service will utilize the next-gen version of Onko-Sure that has been shown to have significantly enhanced sensitivity & specificity. The anticipated 2010 sales are forecasted to be $1.04 million. The current pricing of this CLIA lab cancer testing service is anticipated to be priced at US$149.00 per test. Operating expenses are anticipated to be approximately US$44.00 per test providing a net profit of approximately $105.00 per test. It is also anticipated that there will be approximately US$250K spent on pre-development costs during the first three quarters. This business segment may be operated in cooperation with one or more local laboratory operators. This testing service will utilize approximately 166 Onko-Sure test kits in 2010.
LAB TESTING SERVICES (ASIA-PACIFIC) MARKETING
Our 2010 marketing will initially be focused around web-based Chinese language based social networking outreach and the initial targeting of the physicians and patients residing in: Hong Kong, China, Taiwan, Singapore, Indonesia and Malaysia.
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