19 Jul 2013 07:00
Akers Biosciences, Inc.
("ABI" or the "Company")
Trading Statement
Akers Biosciences, Inc (AIM:AKR), a leading designer and manufacturer of rapid diagnostic screening and testing products, is pleased to announce a positive trading update for the period to 30 June 2013.
As a result of the delivery of 4.9 million CHUBE‐branded, disposable breath alcohol detectors to the Company's new global partner, Chubeworkx Guernsey Limited ("Chubeworkx"), in respect of orders announced in December 2012 and April 2013, plus the collection of product licence fees and a slight increase in the sales of ABI's commercialised PIFA Heparin/PF4 rapid assays; revenues for the half year ended 30 June 2013 are ahead of management expectations with the Company over halfway to its full year target.
To facilitate growth in a much broader, consumer-based alcohol safety market, the Company has developed its global partnership with Chubeworkx, which has the resources and market presence to aggressively pursue a larger target audience for breathalysers through branding and innovative social media campaigns. As of March 2013, a 2012 law took effect mandating that French motorists equip their vehicles with two, "NF‐Marked" breath alcohol detectors. .The "BE CHUBE" initiative (www.bechube.com) was launched by Chubeworkx in Q1 2013 in France to support the launch of "NF-Marked" CHUBE breath alcohol detectors CHUBE is one of four disposable products that have been certified by France's national reference laboratory, Laboratoire National de Métrologie et d'Essais ("LNE") to meet this stringent performance criteria. The product is also certified to be in compliance with AS 3547:1997, the Australian Standardsmark licence for Breath alcohol testing devices for personal use which facilitates market acceptance in New Zealand and South Africa, in addition to Australia. As of 13 June 2013, ABI revised its Licence and Supply agreement with Chubeworkx to extend their reach into North America. As a result, the Company is confident that further orders to support Chubeworkx global strategic plan will be forthcoming.
Sales of PIFA Heparin/PF4 rapid assays continued to show improvement during the first half of 2013, with revenues approximately 2.3% ahead over the same period last year. The Company has achieved this modest growth with 40% less headcount in the Company's Account Executive sales force who are now closely partnering with sales representatives from ABI's US distributors, Cardinal Health and Fisher Healthcare. PIFA Heparin/PF4 tests are the only FDA-cleared, single-use devices that quickly determine if a patient may be developing a drug allergy to the blood thinner, Heparin which can result in life- and limb-threatening blood clots. As was previously announced, the Company is expanding the reach of these products into China through its Beijing-based distribution partner, Novotek Therapeutics Inc. ("Novotek"). Novotek is currently completing required clinical studies and technical documentation for submission to the China Food and Drug Administration ("CFDA") for device marketing approval. In June 2013, ABI's Executive Chairman , Raymond Akers, Jr. PhD introduced the PIFA Heparin/ PF4 Rapid Assay to the Chinese medical and laboratory professional through a keynote address atthe Annual Cardiac Disease Medical Conference in Beijing.
Product pipeline
Aside from breathalysers, the Company's MPC Biosensor technology is being applied to the development of products that detect biomarkers in breath condensate related to various metabolic processes. These emerging, easy-to-use devices are targeted at serving the needs of the weight loss, nutraceutical, diabetic testing, and pulmonary health screening marketplaces as follows:
·; METRON™ measures ketone production associated with fat-burning and can help monitor the success of diet and exercise programs;
·; VIVO™ assesses an individual's oxidative stress levels related to cellular damage and may assist in tracking the effectiveness of supplementation;
·; Breath Ketone "Check" is a convenient rapid test for diabetics to gauge if they may be developing a more severe level of ketone (acid) build up in their body that can cause a life-threatening medical emergency called ketoacidosis; and the
·; Breath PulmoHealth "Check" suite of disposable detectors can signal the detection of various biomarkers related to Asthma, COPD and Lung Cancer.
These products are heading towards full commercialization and the Company is currently assessing distribution opportunities initially in the United States. Devices within the weight loss and nutraceutical categories are generally exempt from FDA 510(k) premarket clearances, while Breath Ketone and PulmoHealth "Check" assays will require regulatory approval.
In addition, ABI's PIFA® technology continues to form the basis of a number of infectious disease rapid assays that are being developed for the expansive third world market. Annually, infectious diseases account for more than 15 million, or one in every two deaths in developing countries. To date, the Company's custom reagent work has focused on a variety of diseases, including, inter alia: Chagas Disease, Chlamydia, Dengue Fever, Malaria and Syphilis. The directors believe that the Company's partnership with Chubeworkx will be of assistance in entering the diagnostic market in major developing countries given their established distribution channels in Africa and Asia.
Thomas A. Nicolette, Chief Executive of ABI, commented,
"We are pleased to inform our shareholders of ABI's substantial commercial progress thus far in 2013. The distribution relationships we have forged internationally and in the United States, have proven to be extremely productive from the perspectives of financial performance and market penetration. We are keenly focused on accelerating the sales growth of our current product offerings and excited to complete the commercialisation of our emerging rapid diagnostic devices for launch into attractive, sizeable markets. We look forward to advising our investors of the Company's achievement of additional business milestones in the coming months."
Enquiries:
Thomas A. Nicolette
President and CEO
Tel. +1 856 848 8698
Antony Legge or James Thomas
Daniel Stewart & Company plc (Nomad and Broker)
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 health status 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, since time is always of essence. ABI is aligned with high volume medical product distributors to help facilitate the Company's growth into a major, worldwide competitor in the field of rapid diagnostics. Additional information on the Company and its products can be found at www.akersbiosciences.com