26 Jun 2013 07:00
26 June 2013
Akers Biosciences, Inc.
("ABI" or the "Company")
Preliminary Results for the Year Ended 31 December 2012
Operational Summary
·; As announced on 17 September 2012, the Company negotiated a multi‐year breathalyser distribution and supply agreement with Chubeworkx Guernsey Limited ("Chubeworkx"), the former Sono International Limited granting them an exclusive licence to market private‐labelled CHUBE breath alcohol detectorsoutside of North Americain exchange for an upfront licence fee of $1,000,000; payment was initially conditional upon, inter alia, the breathalysers being deemed compliant with the French Standard, NF X 20‐702. The Company also began preparing the technical file in support of this certification.
·; Chubeworkx submitted a purchase order to ABI for 3.5 million CHUBE-branded, disposable Breath Alcohol Detectors with an order value of $1,050,000 in aggregate, and remitted $550,000 of the $1,000,000 licensing fee.
·; In late H1 2012, the Company's breath alcohol detector technology was certified under AS 3547:1997, the Australian Standardsmark licence. The "5 ticks mark" for Breath alcohol testing devices for personal use clears the commercial pathway for product sales in Australia, New Zealand, South Africa, and many other countries through ABI's distribution partner, UK-based (en)10 Guernsey Limited" ("(en)10").
·; Forged a distribution relationship with Beijing‐based pharmaceutical andin vitro diagnostics marketer and supplier, Novotek Therapeutics Inc. ("Novotek"), for ABI's Particle ImmunoFiltration Assay ("PIFA") products. The multi‐year agreement assigns exclusive sales and marketing rights for the products to Novotek in China.
·; The Company began shipping PIFA PLUSS PF4 rapid HIT Antibody point-of-care tests into the US market.
·; ABI completed $675,000 private equity raise through the sale of 30 million common shares and 10 million preferred.
Financial Summary
·; Total Revenue for 2012: $1.5 million (2011: $1.8 million)
·; Revenue for the Company's Heparin/PF4 Rapid Assays totalled $1.12 million: (2011: $1.10 million)
·; Gross Profit Margin: 34.4% (2011: 49.9%)
·; Net Loss After Tax Benefit: $2.54 million (2011 loss: $3.58 million)
·; Earnings Before Interest, Depreciation, Taxes & Amortization (EBIDTA): loss $2.2 million (2011 loss: $3.3 million)
·; Basic & diluted loss per share: $0.01 (2011: $0.02)
·; Inventory at year end: $988k (2011: $685k)
·; Company is debt free with current assets in cash and cash equivalents at year-end of $633k (2011: $1.2 million)
Post Year-End Developments
·; The national reference laboratory of France, Laboratoire National de Métrologie et d'Essais ("LNE"), deemed the CHUBE private-labelled breathalyser to be in compliance with the quality criteria defined in French Standard NF X 20-702 for disposable breathalysers. This certification cleared that way for the CHUBE breathalyzers to be marketed by ABI's UK based partner, (en)10, in and around France. The issuance of the "NF Mark" triggered payment from Chubeworkx of the remaining $450,000 of the $1,000,000 licence fee established in Q3 2012.
·; The Company received the second order from Chubeworkx for 1.4 million disposable breath alcohol detectors, bringing the total order to-date under the distribution agreement to 4.9 million units. Within 9 months, these purchases surpassed the minimum quantities that Chubeworkx guaranteed to reach within a 3-year period.
·; On 13 June 2013, ABI announced the extension of the June 2012 License and Supply Agreement with Chubeworkx to include worldwide marketing and distribution of the CHUBE-branded detectors. Chubeworkx has agreed to subscribe for 80 million new common shares in the Company for a total price of $1,600,000. In addition, the parties have entered into a share purchase agreement in which ABI will sell its 20% interest in (en)10 to Chubeworkx for $100,000.
·; The Company and 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.
Thomas A. Nicolette, President and CEO, commented,
"Our 2012 financial performance was disappointing. After the efforts in the first half to rebalance the cost base and move to an indirect sales strategy, it was not until later than anticipated in the second half that the Company began to benefit. The developments announced in H2 2012, and most recently in 2013, demonstrate ABI's dedication to expanding our international and domestic distribution networks through strategic partnerships with experienced, well-positioned organizations in growth-oriented markets. Considerable time and resources were applied to the aforementioned strategic tasks in 2012, including the clinical studies to support the submission of the technical files to obtain Australian and French market certifications for the Company's breath alcohol detection technology. As has been demonstrated in 2013, we believe that these relationships will continue to increase sales for our in-line products and establish a sales structure that can effectively seed new offerings that emerge from the application of our flexible technology platforms."
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 and Chief Executive's Report
The annual financial results for the Company, in US Dollars, for the year ended 31 December 2012 are presented within.
Sales of the Heparin/PF4 Rapid Assays (PIFA and PIFA PLUSS) slightly increased in 2012. However, the growth in sales only picked up in the fourth quarter as the Company began to benefit from the strategy of its dedicated technical sales account executives moving away from a direct selling model to one that works in tandem with over 300 sales representatives of ABI's US distribution partners, Cardinal Health ("Cardinal") and Fisher HealthCare ("Fisher"). The good news is that this growth has continued into the current fiscal year. This strategy allows ABI to have immediate access to key laboratory and pathology decision makers in the majority of American cardiac hospitals and trauma centres. Surgical patients within these facilities are most at risk for developing Heparin-Induced Thrombocytopenia ("HIT"), a life- and limb-threatening complication of treatment with the blood thinner Heparin. Clinical HIT can be described as an allergy to this drug which reverses its intended therapeutic effect and causes blood clots. ABI's assays continue to be the only FDA-cleared rapid, single-use tests available in the United States to screen for HIT; the PIFA straightforward test procedures can be completed 24/7 since specialized equipment and highly trained personnel are not required. Alternative testing methods rely on complex and time-consuming test procedures that are often run infrequently in hospitals or are sent out to reference laboratories. In both of these scenarios, reporting of test results is often delayed for 24-to-72 hours leaving a physician void of important patient information that cannot be factored into time-sensitive anticoagulation decisions.
The Company's ex-US presence for Heparin/PF4 Rapid Assays will begin to expand into Asia in 2013. As announced in Q4 2012, ABI signed an exclusive distribution agreement with Beijing-based, Novotek Therapeutics Inc. ("Novotek"). Novotek, a pharmaceutical and in vitro diagnostics marketer and supplier, is in the process of performing clinical studies to support its 2013 registration of the PIFA Heparin/PF4 Rapid Assay with regulatory authorities in China. Pre-selling activities have already commenced to build awareness of both the prevalence of Heparin-Induced Thrombocytopenia and the unique benefits of PIFA in providing a rapid HIT testing solution, with a formal product introduction at the Annual Chinese Cardiac Disease Medical Convention.
Overall, sales of the PIFA Heparin/PF4 Rapid Assay, combined with the sales generated with the late Q4 launch of PIFA PLUSS PF4, contributed $1,120,000 to ABI's total revenue for 2012.
Sales of rapid tests that incorporate ABI's MPC Biosensor breath condensate technology contributed to the remaining product revenue generated for 2012. The Company's breath alcohol detectors marketed under the brand, BreathScan, together with private labeled versions of the disposable breathalysers, contributed $368,000 to ABI's revenues. Much of ABI's market share currently resides within the human resources ("HR") testing sector. Given the longevity of the BreathScan trade name, some corporate SOPs identify the Company's product by name and therefore have kept sales relatively consistent. However, lower-priced, lower-quality disposable Breath Alcohol detectors began infiltrating the HR market in 2012 which led to an approximate 17% decrease in breathalyser revenue as compared to 2011. As is evident from the Company's numerous 2012 and 2013 announcements, growth in ABI's breath alcohol detection business is moving away from a major concentration in HR toward a strategic focus on alcohol safety on a much broader, consumer-based level. To facilitate this shift, the Company has developed a global partnership with Chubeworkx Guernsey Ltd., a progressive sales and marketing organization that has the resources and market presence to aggressively pursue the much larger target audience for breathalysers through branding and innovative social media campaigns. The "BE CHUBE" initiative (www.bechube.com) was launched Q1 2013 in France to support the launch of "NF-Marked" CHUBE breath alcohol detectors. The French Standard, NF X 20‐702 defines the specifications that chemical breath alcohol detectors must meet in order to be sold to consumers in France; 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. As of March 2013, a 2012 law took effect mandating that French motorists equip their vehicles with two, "NF‐Marked" breath alcohol detectors.
As announced on 10 April 2013, Chubeworkx has already ordered 4.9 million CHUBE tubes to support their European campaign. The product is also already certified to be in compliance with the Australian AS-3547 standard, and 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. As reported, a cash advance of $550,000 was received in 2012 and the issuance of the "NF Mark" triggered payment from Chubeworkx of the remaining $450,000 of the $1,000,000 licence fee established in Q3 2012. The revenue was to be spread over the three years on the contract with $ 27,778 being booked in licencing revenue in 2012. With the minimum order amount having been exceeded already in 2013, the remaining $ 972,222 of the $1,000,000 licencing fee will be booked in H1 2013.
In addition to breath alcohol detectors, the Company's MPC Biosensor technology is being applied to the development of products that serve the nutraceutical and weight loss marketplaces. 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 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 now in 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.
Revenue for 2012 totalled $1,500,000 with a Gross Profit Margin of 34.4%. Both of these numbers are disappointing and the Board anticipates significant improvements in 2013 through revenues resulting from the new distribution agreements being put into place and an improvement in gross profit margin through absorption of underutilized manufacturing overhead.
Expenditures related to the Company's Research and Development activities increased by approximately 3% in comparison to those of 2011 (2012: $717,000 (2011: $698,000)). This is largely due to the development work related to:
·; the customization of ABI's .05% breath alcohol detector to meet the very specific performance criteria of the French Standard, NF X 20‐702;
·; locking in the design of the emerging MPC-based VIVO oxidative stress, single-use analysers; and
·; the refinement of the METRON test to detect ketone levels associated with weight loss.
ABI's sales and marketing expenses decreased from the prior year (2012: $638,000 (2011: $707,000)) as management streamlined the Company's sales model to include fewer technical sales professionals. As previously mentioned, the ABI account executive team began to work collaboratively with both Cardinal and Fisher outside sales representatives in 2012. As result, synergies in territory composition made some sales positions obsolete and allowed the Company to maintain national coverage with less head count by the end of Q3 2012.
ABI's net loss after tax benefit is $2.54 million (2011 loss: $3.58 million) and basic & diluted loss per share is $0.01 (2011 loss: $.02). The total value of inventory held by the Company at 31 December 2012 was $988k (2011: $685k)).
Outlook
For 2013, ABI has already demonstrated that its strategic move toward alcohol safety initiatives within the aggregate consumer marketplace is a model that should bode favourably for the Company and its shareholders. The Chubeworkx partnership provides ABI with a sole source manufacturing demand pipeline for breath alcohol detectors and may also open up international markets for the Company's PIFA rapid infectious disease products given Chubeworkx strong ties to Asia and Africa. ABI is dedicated to growing its Heparin/PF4 Rapid Assay global market share - in the United States through a collaborative sales approach that pairs ABI's technical sales team with the depth of the Company's national distribution sales forces, and internationally through agreements with specialized, well-established medical device companies. ABI is excited at the prospect of entering the nutraceutical market with a line of breath condensate detectors that can serve as companion tests to monitor progress with medically-assisted weight loss and health-and-wellness programs. Finally, the Company will be proceeding with clinical trials to support FDA 510(k) submissions for various rapid, breath condensate screening tests including the Breath Ketone "Check" test for diabetic screenings for ketoacidosis and the Breath PulmoHealth "Check" suite of products for Asthma, Chronic Obstructive Pulmonary Disease (COPD) and Lung Cancer.
The Directors believe that the continuing improvement in the Company's commercial prospects is not reflected in its current share price and that this has a detrimental impact on the Company's options for growth. The Directors are reviewing a number of alternatives designed to rapidly improve the situation.
Thomas A. Nicolette, President and Chief Executive Officer
Raymond F. Akers, Jr. PhD, Executive Chairman of the Board
26 June 2013
AKERS BIOSCIENCES, INC AND SUBSIDIARIES | |||
Consolidated Balance Sheets | |||
As of 31 December 2012 and 2011 | |||
2012 | 2011 | ||
Note | $ | $ | |
ASSETS | |||
Non-Current Assets | |||
Property, plant and equipment, net | 7 | 240,014 | 341,433 |
Intangible assets, net | 8 | 3,692,855 | 3,934,408 |
Other Assets | 4,572 | 4,572 | |
Total Non-Current Assets | 3,937,441 | 4,280,413 | |
Current Assets | |||
Inventories (net) | 9 | 987,853 | 685,675 |
Trade Receivables (net) | 10 | 115,723 | 639,725 |
Notes Receivable | 11 | 225,000 | - |
License Fee Receivable | 12 | 450,000 | - |
Other Current Assets | 67,898 | 84,567 | |
Cash and Cash Equivalents | 633,022 | 1,192,805 | |
Total Current Assets | 2,479,496 | 2,602,772 | |
Total Assets | 6,416,937 | 6,883,185 | |
EQUITY | |||
Convertible Preferred Stock | 13 | 225,000 | - |
Common Stock | 13 | 83,273,376 | 82,822,308 |
Accumulated Deficit | (79,194,707) | (76,653,906) | |
Total Equity | 4,303,669 | 6,168,402 | |
LIABILITIES | |||
Current Liabilities | |||
Trade and Other Payables | 16 | 1,141,046 | 714,783 |
Deferred Revenue | 17 | 972,222 | - |
Total Current Liabilities | 2,113,268 | 714,783 | |
Total Liabilities | 2,113,268 | 714,783 | |
Total Equity and Liabilities | 6,416,937 | 6,883,185 | |
AKERS BIOSCIENCES, INC AND SUBSIDIARIES | |||
Consolidated Statements of Operations | |||
For the years ended 31 December 2012 and 2011 | |||
2012 | 2011 | ||
Note | $ | $ | |
Revenues: | |||
Product Revenue | 1,494,585 | 1,785,068 | |
License Revenue | 27,778 | - | |
Total Revenue | 1,522,363 | 1,785,068 | |
Cost of Sales: | |||
Product Cost of Sales | 21 | (1,007,951) | (956,620) |
Total Cost of Sales | (1,007,951) | (956,620) | |
Gross Profit | 514,412 | 828,448 | |
Other Income | 22 | 44,892 | 316,819 |
Administrative Expenses | 10,21 | 1,493,707 | 3,188,137 |
Sales and Marketing Expenses | 638,732 | 707,790 | |
Research and Development Expenses | 717,155 | 698,426 | |
Non-Cash Share Based Compensation | - | 27,766 | |
Amortization of Non-Current Assets | 424,778 | 375,978 | |
Loss from Operations | (2,715,068) | (3,852,830) | |
Other Income/Expenses | |||
Foreign Currency Transaction (Income)/Expense | (6,859) | 29,628 | |
Investment (Income)/Expense | - | (290) | |
Total Other Expense/(Income) | (6,859) | 29,338 | |
Loss Before Income Taxes | (2,708,209) | (3,882,168) | |
Income Taxes | |||
Income Tax Benefit | 6 | 167,408 | 297,890 |
Total Income Taxes Income/(Expense) | 167,408 | 297,890 | |
Net Loss | (2,540,801) | (3,584,278) | |
Basic & diluted loss per common share | 14 | $ (0.01) | $ (0.02) |
Weighted average basic & diluted common | |||
shares outstanding | 178,316,486 | 163,519,502 | |
AKERS BIOSCIENCES, INC AND SUBSIDIARIES | |||
Consolidated Cash Flow Statements | |||
For the years ended 31 December 2012 and 2011 | |||
Year Ended 31-Dec-12 | Year Ended 31-Dec-11 | ||
Note | $ | $ | |
Cash flows from operating activities | |||
Net loss for the year | (2,540,801) | (3,584,278) | |
Adjustments for: | |||
Provisions for bad debts | 9,047 | 1,650,185 | |
Provision for inventory obsolesence | 32,000 | - | |
Non-cash equity position in BreathScan Int'l | - | (290) | |
Non-cash share based compensation | - | 27,766 | |
Depreciation and amortization of non-current assets | 537,882 | 525,332 | |
(1,961,872) | (1,381,285) | ||
Movements in working capital | |||
(Increase)/decrease in trade receivables | 256,016 | (213,373) | |
(Increase)/decrease in other receivables | 258,939 | (263,436) | |
(Increase) in inventories | (334,178) | (52) | |
(Increase)/decrease in other assets | 16,669 | (2,687) | |
Increase/(decrease) in trade and other payables | 319,339 | (400,929) | |
Increase in legal settlement liabilities | 106,924 | - | |
Increase in deferred revenue | 522,222 | - | |
1,145,931 | (880,477) | ||
Net cash used in operating activities | (815,941) | (2,261,762) | |
Cash flows from investing activities | |||
Purchases of property, plant and equipment | (11,685) | (57,179) | |
Capitalized development costs | (183,225) | (190,550) | |
Net cash used in investing activities | (194,910) | (247,729) | |
Cash flows from financing activities | |||
Proceeds from issuance of common stock | 451,068 | 3,017,746 | |
Proceeds from issuance of warrants | - | 261,300 | |
Net cash from financing activities | 451,068 | 3,279,046 | |
Net decrease in cash and cash equivalents | (559,783) | 769,555 | |
Cash and cash equivalents at beginning of year | 1,192,805 | 423,250 | |
Cash and cash equivalents at end of year | 633,022 | 1,192,805 | |
Supplemental Disclosure of Cash Flow Information | |||
Non-cash financing activities | |||
Exchange of a long-term receivable, less impingement and | |||
deferred revenue for patent rights | - | 2,062,410 | |
Issuance of convertible preference stock for note receivable | 225,000 | - | |
Other receivable for deferred revenue | 450,000 | - | |
AKERS BIOSCIENCES, INC AND SUBSIDIARIES | |||||
Consolidated Statement of Changes in Equity (Deficit) | |||||
For the years ended 31 December 2012 and 2011 | |||||
Convertible | |||||
Preferred | Common | ||||
Stock | Stock | Accumulated | Total | ||
(Note 13) | (Note 13) | Deficit | Equity | ||
Note | $ | $ | $ | $ | |
Balance at 31 December 2010 | - | 79,515,496 | (73,069,628) | 6,445,868 | |
Changes in Equity for 2011 | |||||
Net loss for the year | - | - | (3,584,278) | (3,584,278) | |
- | 79,515,496 | (76,653,906) | 2,861,590 | ||
Recognition of share based payments for options & warrants | 13 | - | 27,766 | - | 27,766 |
Issue of Shares | 13 | - | 3,017,746 | - | 3,017,746 |
Exercise of warrants & stock options | 13 | - | 261,300 | - | 261,300 |
Balance at 31 December 2011 | - | 82,822,308 | (76,653,906) | 6,168,402 | |
Changes in Equity for 2012 | |||||
Net loss for the year | - | - | (2,540,801) | (2,540,801) | |
Issue of Shares | 13 | 225,000 | 451,068 | - | 676,068 |
Annual Report and Accounts
The Annual Report and Accounts will be posted to shareholders on 28 June 2013 and will be available thereafter on the Company's website: www.akersbiosciences.com.