5 Jan 2011 07:00
Embargoed: 0700hrs 5 January 2011
Akers Biosciences, Inc.
("ABI" or the "Company")
Trading Statement
Review of 2010
Akers Biosciences, Inc (AIM:AKR), a leading designer and manufacturer of rapid diagnostic screening and testing products, anticipates that, as a result of continuing improvement in the sales of its commercialised diagnostic products, revenues for the year ended 31 December 2010 should exceed current market expectations by approximately 85 per cent.
As announced on 29 December 2010, the Company received its first product order under a recently established distribution agreement in the Middle East, for Tri-Cholesterol "Check" tests, supplied to Al Tadawi Medical Equip TR LLC. Recognition of revenues occurs up front on shipment of the product. Approximately 90 per cent of the units were shipped before the end of 2010, boosting revenues by around $1.5m. These are the first volume sales of ABI's Tri-Cholesterol "Check" tests, which the directors believe to be the only rapid test in the world to measure HDL, LDL and Total cholesterol levels. The test requires only a finger-prick blood draw and is designed for use both by healthcare professionals and as a potential over-the-counter self-test.
Sales of PIFA Heparin/PF4 Rapid Assay continued to show improvement during the year with revenues approximately 37 per cent higher than in 2009. The PIFA HPF4 test is the only FDA-cleared device that quickly determines if a patient, being treated with the blood thinner Heparin, may be developing a drug allergy that can result in life- and limb-threatening blood clots. The sales growth over the prior year is, in part, due to the expansion of US distribution in June 2010 to include Fisher HealthCare alongside Cardinal Health. The combination of these two distributors has more than trebled the number of sales personnel marketing the PIFA HPF4 test and exposed the product to almost all the hospitals in the US. Additionally ABI has invested in the Company's own direct sales capability, for which management is confident of a continuing positive impact in the current year. In 2010, over 85 per cent of product trials generated through direct sales led to adoption of the PIFA HPF4 assay.
Sales of BreathScan, the Company's line of disposable breath alcohol detectors have shown improvement in 2010 over the prior year with sales in both the USA and overseas. The establishment in March 2010 of BreathScan International Limited (20 per cent. owned by ABI) as an international distributor for the product has led to initial orders being received for BreathScan units from South Africa, New Zealand, Australia and the UK for a variety of applications including alcohol safety programmes and for industrial and commercial use.
Product pipeline
ABI recently completed development of a point-of-care version of the PIFA HPF4 product, which will enable the test to be completed instantly at the patient's bedside using whole blood. This product line extension is now being marketed alongside the existing PIFA HPF4 assay and is expected to have a further positive impact on growth of the product in 2011.
2011 will also see development continuing on a number of new products which should impact growth in 2012.
The Company has begun marketing an extension of the BreathScan product line - the BreathScan PRO - targeted at specialist law-enforcement product distributors. This product merges the Company's disposable, proprietary breath alcohol detection technology with the quantitative precision of an electronic analyser providing users with a testing platform that can be used in probable cause situations by law enforcement, schools, and transportation industries.
A number of new products that incorporate ABI's breath condensate platform technology are in development and are designed to replace existing mass market tests with more convenient, less invasive and faster testing formats.
The Breath Ketone "Check" test is a rapid, diabetic screening device that will test for dangerous levels of Ketones. Ketones are acids that build up in the blood when the body doesn't have enough insulin and, if left untreated, can lead to severe complications, including diabetic coma or kidney failure. After completing highly successful clinical studies during 2010 that compared the accuracy of the test against standard laboratory methods, the Company has submitted its technical file for FDA regulatory clearance and received CE-mark approval required to move forward with marketing of the product. Initial sales of Breath Ketone "Check" are expected to be generated towards the end of the year.
In addition to lung cancer, the BreathPulmo Health "Check" product line is also being developed to test for a number of other pulmonary conditions including asthma and chronic obstructive pulmonary disease (COPD) and is expected to enter into clinical trials during 2011.
Current trading
The positive trading momentum for PIFA HPF4, Tri-Cholesterol "Check" and BreathScan products last year has continued into 2011 with a strong January order book.
Thomas A. Nicolette, Chief Executive of ABI, commented,
"Our currently commercialised products are showing continuing improvement as evidenced by progress in 2010. In development, we have breath condensate tests for conditions associated with diabetes and pulmonary diseases which address extremely large diagnostic markets. We are focused on accelerating the development of these tests in the coming months."
Enquiries:
Thomas A. Nicolette
President and CEO
Tel. +1 856 848 8698
Ben Simons
M: Communications
Tel. +44 (0)20 7920 2340
Antony Legge / Emma Earl
Daniel Stewart
Tel. +44 (0)20 7776 6550
About Akers Biosciences, Inc.
Akers Biosciences develops, manufactures, and supplies rapid, point of care screening and testing products designed to bring healthcare information both rapidly and directly to the consumer or healthcare provider. The Company has advanced the science of diagnostics while responding to major shifts in healthcare through the development of several proprietary platform technologies. The company's state-of-the-art rapid diagnostic assays can be performed virtually anywhere in minutes when time is of the essence. ABI has aligned with major healthcare companies and high volume medical products distributors to maximize product offerings, and to be a major worldwide competitor in diagnostics. Additional information on the Company and its products can be found at www.akersbiosciences.com