AKR.L Regulatory News (AKR)

Embargoed: 0700hrs, 22 August 2013

NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, TO U.S. NEWSWIRE SERVICES OR FOR RELEASE, PUBLICATION OR DISSEMINATION IN OR INTO OR FROM THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION

Akers Biosciences, Inc.

("ABI" or the "Company")

Interim Results for the Six Months Ended 30 June 2013

ABI, a leading designer and manufacturer of rapid diagnostic screening and testing products, is pleased to announce its interim results for the half year ended 30 June 2013.

Financial Highlights

· Revenues up 235% to $2,639,085 (H1 2012: $787,194) as Company benefits from the initial deliveries of the CHUBE breathalysers

· Product revenue totalled $2,272,418 compared to $787,194 during the same period in 2012, with $1.47m (nearly two thirds of total product revenue for the period) coming from the delivery of 4.9 million disposable breath alcohol detectors delivered to Chubeworkx Guernsey Ltd ("Chubeworkx")

· PIFA Heparin/PF4 Rapid Assay revenues totalled $611,031, a 2.4% increase in comparison to H1 2012

· Licensing revenue during the period was $366,667, compared to $0 in the prior half-year ended June 2012

· Moves into profit for the period for the first time since 2008 with Profit Before Tax of $90,235 (H1 2012: Loss $1,023,283)

· Positive cash flow from operations with EBITDA of $369,324 (H1 2012: Loss $782,580)

· Company continues to be debt free with current assets in cash and cash equivalents of $1,553,884 (H1 2012: $482,950)

Operational Highlights

· ABI's proprietary disposable breath alcohol received the final award of the NF Marque ("NF Mark") number 18/01 providing market clearance for the breathalysers to be sold to consumers in and around France

· ABI extended its licence and supply agreement with Chubeworkx giving them exclusive rights to market private‐labelled versions of the Company's breath alcohol detectors worldwide;

· Chubeworkx subscribed for 80,000,000 new common shares for a total price of $1,600,000

· The Company and its Chinese distributor, Novotek Therapeutics Inc. ("Novotek") introduced the PIFA Heparin Platelet Factor 4 Rapid Assay to the Chinese market through a keynote address at the Annual Cardiac Disease Medical Conference in Beijing. Clinical trials were begun after this conference, which should result in regulatory approval to sell product in H1 2014.

Post H1 2013 Developments

· On 1 July the Company announced that Gavin E.D. Moran and Thomas J. Knox were appointed to the board as Non-Executive Directors.

· On 8 August ABI announced that it was seeking a listing of the Company's common stock on The NASDAQ Capital Market ("NASDAQ") in the USA. Simultaneous with the potential NASDAQ listing, the Company is also seeking to raise additional capital via a registered public offering of approximately $15,000,000 of its common stock. A registration statement relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective.

Thomas A. Nicolette, President and Chief Executive Officer, commented,

"The Company's goals for the first half of 2013 centered around revenue growth for disposable breath alcohol detectors that utilise ABI's MPC Biosensor technology. The momentum started in late December of 2012 with Chubeworkx' initial order for 3.5 million units of their custom, CHUBE breath alcohol detectors, and continued with the Company accepting a subsequent purchase order for an additional 1.4 million CHUBE devices in April of this year.

Our primary focus moving forward is to expand the domestic and international distribution of our PIFA Heparin/PF4 rapid assays and support Chubeworkx in their international sales and marketing efforts for the CHUBE private-labeled breath alcohol detectors. We are working with international distributors in the EU and China to initiate product sales of our PIFA Heparin/PF4 rapid assays to facilities in those regions beginning in the latter part of 2013. Meanwhile, we believe the extension of our agreement with Chubeworkx may bring further orders as they continue to their global marketing plan.

The Company continues development activities for its PIFA infectious disease single-use assays, METRON, Breath Ketone "Check", VIVO and Breath PulmoHealth "Check" products, including advancement of the steps required for FDA clearance or CE marking in the EU where necessary.

We look forward to keeping our valued and ever-supportive investors abreast of our commercial progress and financial performance."

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

Chairman's & Chief Executive's Joint Statement

We are pleased to provide an overview of the Company's performance for the six months ended 30 June of the current financial year.

Financial Review

Revenue in the first half of 2013 was $2,639,085 (H1 2012: $787,194).EBITDA was $369,324 (H1 2012: Loss of $782,580). Profit before Tax was $90,235 (H1 2012: Loss of $1,023,283). The Company continues to be debt-free with current assets in cash and cash equivalents of $1,553,884 (H1 2012: $482,950). Gross Profit Margin was slightly down to 47% (H1 2012: 50%), due to increased manufacturing costs incurred in the ramp up to produce CHUBE devices. 

Product Review

The Company's total revenue as of 30 June 2013 was $2,639,085, a 235% increase over the same period in 2012, with product revenue contributing $2,272,418 as compared to $787,194 last year. Licensing revenue during the period was $366,667, compared to $0 during the same period in 2012.

The significant increase of product revenue in the first half of 2013 was mainly attributed to the $1.47m of revenue, nearly two thirds of total product revenue, generated through the manufacturing and shipping of CHUBE-branded disposable breath alcohol detectors under the Company's Supply and Licensing Agreement with Chubeworkx.

The private labeled CHUBE tubes are certified under two international quality standards:

· AS 3547:1997, the Australian Standardsmark license, referred to as the "5 ticks mark" for Breath alcohol testing devices for personal use; and

· NF X 20-702, the French Standard for disposable breathalyzers

These certifications cleared the way for the CHUBE breathalyzers to be marketed by ABI's UK based partner, (en)10 Guernsey Limited ("en10"), in Australia, New Zealand, South Africa, and in and around France. Chubeworkx has ordered 4.9 million tubes since the December 2012, all of which were delivered as of June 30, 2013.

Under the licensing portion of the agreement which originated in September 2012, the Company granted Chubeworkx an exclusive license to market their private-labeled CHUBE breath alcohol detectors outside of North America in exchange for an upfront license fee of $1,000,000 which has been received in full. In 2012, the Company recognized $27,778 of the license fee as revenue and in the six months ended June 2013, booked an additional $166,667; this was on top of the $200,000 license fees received for the Company's VIVO product. On 13 June 2013, ABI announced that it had extended the reach of Chubeworkx' exclusive territory to include North America, in return for selling its equity ownership of en10 to Chubeworkx for $100,000. In addition, Chubeworkx subscribed for 80,000,000 shares of common stock in the Company for a total price of $1,600,000.

The Company also experienced growth in US sales of its PIFA Heparin/PF4 rapid tests, up 2% over the same period last year which was achieved despite a 40% reduction in headcount in the Company's account executive sales force, however, the Company believes that sales growth can improve due to the formal launch of a product line extension intended for point of care testing, PIFA PLUSS PF4, in H2. PIFA Heparin/PF4 Rapid Assay and PIFA PLUSS PF4 remain the only FDA-cleared rapid manual assays that quickly determines if a patient, being treated with the blood thinner Heparin, may be developing a drug allergy. This clinical syndrome, referred to as Heparin-Induced Thrombocytopenia ("HIT"), reverses the Heparin's intended therapeutic effect and transforms it into a clotting agent. Since PIFA results are obtained in under 10 minutes of the initiation of the simple test procedure, obtaining a timely test result is paramount to a physician's ability to effectively formulate a diagnosis and subsequent treatment plan. ABI continues to expand its US customer base for these rapid tests with the Company's account executive sales force working in tandem with Cardinal Health and Fisher Healthcare. In the latter part of this year, ABI will initiate product sales in the EU and China through its evolving distribution network.

ABI's 2013 product development plans focused largely on the Company's MPC Biosensor technology. Many of the emerging products provide monitoring solutions for the nutraceutical and weight loss marketplaces as biomarkers related to various metabolic processes can be measured in breath condensate. As a result, ABI has used its proprietary, easy-to-use platform to design disposable breath tubes that measure ketone (acid) production associated with fat-burning (METRON) and oxidative stress levels that relate to cellular damage and the development of many preventable diseases (VIVO). These products are heading towards full commercialization and the Company is currently assessing distribution opportunities with companies specializing in medically-assisted weight loss and/or mass distribution through health-related multilevel marketing organizations.

ABI is also continuing its clinical development of the Breath Ketone "Check" disposable breath tube for two clinical indications:

· provide real-time information that allows diabetics to determine if they have a more severe level of ketone (acid) build up in their body that can cause a life-threatening medical emergency called ketoacidosis; and

· aid in the management of senile dementia and Alzheimer's disease since maintaining a "safe" state of ketosis has been found to slow the progress of the disease.

The Company is also allocating R&D resources to the development of the Breath PulmoHealth "Check" suite of assays. These disposable detectors will signal the detection of various biomarkers related to pulmonary health, namely asthma, chronic obstructive pulmonary disease ("COPD") and lung cancer, through convenient, rapid analysis of an individual's breath sample.

Outlook

For the remainder of 2013, ABI is focused on expanding domestic and international distribution of our PIFA Heparin/PF4 rapid assays and supporting Chubeworkx in their plans to integrate their innovative CHUBE alcohol safety programs and initiatives into worldwide markets. The Company will have visibility on sales from new product sources as METRON and VIVO are commercialized in H2 2013. Moreover, the Company is committed to continuing the development and commercialization of its Breath Ketone "Check", Breath PulmoHealth "Check" and PIFA Infectious Disease products. The Company believes the positive performance in H1 provides a solid foundation for sustained revenue growth in H2 2013 and beyond.

Raymond F. Akers, Jr. PhD - Executive Chairman

Thomas A. Nicolette - President and Chief Executive Officer--

22 August 2013