28 Mar 2014 11:00
28 March 2014
Akers Biosciences, Inc.
("ABI" or the "Company")
Results for the Year Ended 31 December 2013
Highlights
Financial Highlights
· 2013 revenues increased by 129% to $3.6 million (2012: $1.6 million)
· Gross Profit Margin: 47% (2012: 36%)
· Net Loss After Tax Benefit reduced to $1.5 million (2012 loss: $2.6 million)
· EBITDA: loss $1.2 million (2012 loss: $2.4 million)
· Basic & diluted loss per share reduced to $0.96 (2012: $2.24)
· Inventory at year end: $1.03 million (2012: $988,000)
· Company is debt free
Operational Highlights
· February 2013: ABI's proprietary disposable breath alcohol detectors were granted NF Marque ("NF Mark") status enabling the breathalysers to be marketed and sold to consumers in and around France under the brand name CHUBE by ABI's UK based partner (en)10.
· June 2013: signed amended License and Supply Agreement with Chubeworkx and (en)10 to expand marketing and distribution of Chubeworkx "BE CHUBE" breath alcohol program worldwide using ABI-manufactured breathalysers.
· June 2013: Chubeworkx purchased 512,820 shares of common stock in ABI for an aggregate $1.6 million.
· August 2013: ABI announced that it was seeking a listing of the Company's shares on The NASDAQ Capital Market to raise additional capital via a registered public offering of approximately $15 million of its common stock (see Post Year-End Developments).
· December 2013: ABI raised gross proceeds of £490,510 (approximately $800,000) via a private placement to institutional and other investors in the UK.
Post Year-End Developments
· January 2014: successfully completed an initial public offering of the Company's stock on The NASDAQ Capital Market, raising approximately $15 million in gross proceeds in a fully subscribed offering. Net proceeds are being used for general corporate purposes including working capital, product development and fulfillment, marketing activities, expansion of internal sales organization, further development of sales channels, and other capital expenditures. By achieving this financial stability, the Company can now focus entirely on the execution of its business plan.
· March 2014: ABI announced that Raymond F. Akers, Jr. PhD, the Company's co-founder and Executive Chairman of the Board, would assume the duties of President and CEO effective 28 March 2014, positions previously been held by Thomas A. Nicolette; Mr. Nicolette will also be stepping down from the Company's Board of Directors on 28 March 2014.
· March 2014: ABI announced the appointment of diagnostic industry sales and marketing expert, Edwin C. Hendrick, as the Executive Vice President, Sales and Marketing.
The Company will conduct a conference call on Monday, 31 March 2014 at 10:15 a.m. Eastern time / 3:15 p.m GMT:
Domestic: | 877-941-8416 |
International: | +1.480-629-9808 |
Conference ID: | 4675979 |
Webcast: | http://ir.akersbiosciences.com/events.cfm |
Replays - Available through 10 April 2014 | |
Domestic: | 877-870-5176 |
International: | +1. 858-384-5517 |
Conference ID: | 4675979 |
As previously announced on 15 November 2013, since the Company's listing on The NASDAQ Capital Market, it is stating its final results in US GAAP. Accordingly, these results include a comparison table to show the effects of the change from IFRS to US GAAP.
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. The Company 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.
Cautionary Statement Regarding Forward Looking Statements
Statements contained herein that are not based upon current or historical fact are forward-looking in nature and constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements reflect the Company's expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties. These statements include but are not limited to statements regarding the intended terms of the offering, closing of the offering and use of any proceeds from the offering. When used herein, the words "anticipate," "believe," "estimate," "upcoming," "plan," "target", "intend" and "expect" and similar expressions, as they relate to Akers Biosciences, Inc., its subsidiaries, or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties, and other factors that could cause the Company's actual results, performance, prospects, and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements.
For more information:
Raymond F. Akers, Jr. PhD
Executive Chairman of the Board
Akers Biosciences, Inc.
Tel. +1 856 848 8698
Brendan Hopkins
RedChip Companies, Inc. (US Investor Relations)
Tel. +1 407 644 4256 x134
Antony Legge / James Thomas
Daniel Stewart (UK Nominated Adviser and Broker)
Tel. +44 (0)20 7776 6550
Ben Simons
Vigo Communications (UK Investor Relations)
Tel. +44 (0)20 7016 9574
Chairman's and Chief Executive's Report
The annual financial results for the Company, in US Dollars, for the year ended 31 December 2013 are presented within. As noted in the 2012 Annual Report and Accounts, the Board anticipated significant improvements in 2013. ABI is pleased to report that revenues for the year ended 31 December 2013 totaled $3,577,851 - a 129% increase over the same period in 2012. Licensing revenues increased by 1,820% and product revenues improved by 98%. Gross profit margin improved to 47% from 36% in 2012.
The significant increase in MPC product revenues is attributed to our world-wide distribution agreement with Chubeworkx. During the year ended 31 December 2013, Chubeworkx's CHUBE-branded product accounted for $1,719,340 of our MPC product revenue and an additional $333,333 in licensing fees. Additional breath alcohol detector revenue was achieved through sales of ABI's BreathScan disposable detectors and US private-labeled versions, mostly within the human resources ("HR") testing sector related to on-the-job safety. Growth in ABI's breath alcohol detection business has and will continue to be achieved through a shift in strategic focus to the broader consumer-based wellness market, especially through the Company's global partnership with Chubeworkx. Their "BE CHUBE" program aggressively pursues a much larger target audience for breathalysers through branding and innovative social media campaigns that support responsible alcohol consumption.
The CHUBE .05% detector is the only US-manufactured single-use breathalyser to have US FDA-clearance, the NF Mark granted by France's national reference laboratory, Laboratoire National de Métrologie et d'Essais ("LNE"), and certification through the Australian AS-3547 standard; only three non-US manufactured-breathalysers hold these same designations. In March 2013, a 2012 law took effect in France mandating that motorists traveling throughout France equip their vehicles with two NF Marked breath alcohol detectors; while in Australia, since 2010, police have full authority to pull drivers over at any time to administer a breath alcohol test irrespective of driving behavior. CHUBE's European and Australian campaigns have continued to drive production demand for the Company's breathalysers in 2014, and the imminent launch of the "BE CHUBE" program in the US - an initiative that the Company will be instrumental in facilitating - is expected to maintain product volume requirements in the current fiscal year.
In addition to breath alcohol detectors, the Company's MPC Biosensor technology forms the basis of two products within the broad and emerging multi-billion dollar wellness product category; these offerings had a soft launch in 2013 and did not make significant contributions to revenue. Since biomarkers related to various metabolic processes can be measured in breath condensate, ABI has applied its proprietary, easy-to-use platform for the non-invasive measurement of ketone production that is related to fat-burning (METRON) and oxidative stress levels indicative of cellular damage, found by scientists to be directly correlated to the aging process and many serious and life-threatening illnesses, including cancer, diabetes and cardiovascular disease (VIVO). The Company is currently marketing the products direct to end-users and is assessing distribution opportunities with network marketing companies in the health and wellness arena.
The Company's PIFA Heparin/PF4 and PIFA PLUSS PF4 screening tests are the only FDA-cleared, single-use assays available to American hospitals to help quickly rule-out Heparin-Induced Thrombocytopenia ("HIT"), a life- and limb-threatening complication of treatment with the blood thinner Heparin, especially in cardiac surgery patients. In late 2012, the Company's dedicated technical sales account executives began 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"). 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. This reorganization and the need to build relationships with distributor representatives hampered 2013 domestic sales growth but set the stage for an enhanced selling effort in 2014. In addition, the PIFA PLUSS PF4 product line extension was just added to Fisher's product roster in January 2014. These expansion and relationship-building initiatives have already delivered a measureable increase in product trials and adoptions in the current fiscal year. International sales of the PIFA Heparin/PF4 Rapid Assay, especially in China, are expected to ramp up later this year. The Company's exclusive distributor in the region, Novotek Therapeutics Inc. ("Novotek"), a Beijing-based pharmaceutical and in vitro diagnostic business development corporation, is working to obtain regulatory clearances to facilitate product sales in this expansive market. For the current fiscal year, the Company is actively seeking distribution opportunities in Mexico, Colombia and India where the availability of rapid HIT-testing options is at a minimum. To facilitate easier entry into these and other markets, the Company is pursuing certification against the internationally-recognized quality management system standard, ISO 13485.
Cost of sales for the year ended 31 December 2013 increased by 90% to $1,913,844 compared to the same period in 2012 ($1,007,951). The rise in cost of sales is attributed to the increased consumption of raw materials and other manufacturing components, as well as the use of temporary labor and sub-contractors primarily due to the significant increase in breathalyser production to meet enhanced sales demand.
Although the total cost of sales increased, ABI's gross profit margin improved significantly to 47% for the year ended 2013 (36% in 2012). Although the total cost of sales increased, ABI's gross profit margin improved to 47% for the year ended 2013 as compared to 36% in 2012. The improvement in gross profit margin was derived from a significant increase in licensing fees ($533,333 in 2013 as compared to $27,778 in 2012) and an increase in production volume which allowed us to improve efficiency by producing materials in larger lots, reducing setup, quality assurance testing and other production costs associated with the manufacturing process.
Sales and marketing expenses in the year ended 31 December 2013 totaled $684,720, which was a 7% increase as compared to $638,732 for the year ended 2012. The increase was the result of the payment of royalties related to the improved breathalyser sales. In addition, general and administrative expenses in the year ended 31 December 2013 totaled $1,524,626, which was a 2% increase as compared to $1,493,707 for the year ended 2012. Research and development expenses in the year ended 31 December 2013 totaled $1,006,800, which was an 11% increase as compared to $900,380 for the year ended 2012. This increase was due to expanded development of the PIFA Heparin/PF4 Rapid Assay products and the METRON single-use ketone test for the health & wellness industries.
ABI's net loss after tax benefit for 2013 is $1,526,773, which is a 40% improvement over the same period last year (2012 loss: $2,557,820). Basic and diluted loss per share, adjusted for the 1-for-156 reverse stock split effected in November 2013 is $0.96 (2012 loss: $2.24). The total value of inventory held by the Company at 31 December 2013 was $1,025,104 (2012: $987,853); the increase in comparison to the same period in the prior year is due to inventories that have been built-to-order for Chubeworkx pending final delivery instructions. Cash at 31 December 2013 was $103,634 and the Company remains debt-free.
The NASDAQ Capital Market IPO
On 8 August 2013, ABI announced that it was seeking a listing of the Company's shares on The NASDAQ Capital Market ("NASDAQ") to raise additional capital via a registered public offering of approximately $15 million of its common stock. Substantial resources were dedicated in the second half of 2013 to this event which culminated in the closing of a fully subscribed offering on 28 January 2014 and the admission of ABI's shares to trading on NASDAQ under the symbol "AKER." The Company received approximately $15 million in gross proceeds, before underwriting discounts, commissions and offering expenses. The Company is using the net proceeds for general corporate purposes, including working capital, product development and fulfillment, marketing activities, expansion of internal sales organization, further development of sales channels, and other capital expenditures. By achieving this financial stability, the Company can now focus entirely on the execution of its business plan.
In anticipation of the NASDAQ IPO, on 3 December 2013 Mr. Thomas J. Knox, shareholder and member of the ABI Board, converted all 10,000,000 shares of his Series A Preferred Stock into 261,997 shares of common stock pursuant to the terms of the Series A Preferred Stock.
On 22 November 2013 the Company effected a 1-for-156 reverse stock split.
Outlook
As a result of improved revenue performance in 2013 and the successful NASDAQ IPO that was announced on 23 January 2014, the Company has financial stability and, with that, the opportunity to exclusively focus on the execution of its well-defined business plan. This plan involves a comprehensive US launch of a number of products derived from our breath condensate MPC Biosensor technology, namely CHUBE breathalysers, and a growing wellness product roster that includes METRON and VIVO. In addition, resources are also being dedicated to expanding sales of ABI's PIFA Heparin/PF4 assays by introducing these FDA-cleared, rapid tests into various international markets and pursuing a more aggressive stance in the US by strengthening our selling network. The next phase of our corporate strategy is also dedicated to the rapid commercialization of our near-term products which include the Company's PIFA-based infectious disease single-use Malaria and Chlamydia assays which are in-demand in the Developing World. Finally, the Company will continue work on its clinical development program to support the regulatory approval process of two additional MPC Biosensor products, Breath Ketone "Check" for diabetic screenings for ketoacidosis and the Breath PulmoHealth "Check" suite of products for Asthma, Chronic Obstructive Pulmonary Disease (COPD) and Lung Cancer. The Company is optimistic about its prospects as it enters a new phase in its development, and appreciates the ongoing support of its strategic initiatives by its shareholders.
Raymond F. Akers, Jr. PhD, Executive Chairman of the Board
Thomas A. Nicolette, President and Chief Executive Officer
28 March 2014
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES | |||||||
Consolidated Balance Sheets | |||||||
December 31, 2013 and 2012 | |||||||
2013 | 2012 | ||||||
ASSETS | |||||||
Current Assets | |||||||
Cash and Cash Equivalents | $ 103,634 | $ 633,022 | |||||
Trade Receivables (net) | 118,404 | 101,213 | |||||
Trade Receivables - Related Party | 1,209,388 | 10,013 | |||||
Other Receivables | 748,962 | 4,497 | |||||
Note Receivable - Related Parties | - | 225,000 | |||||
License Fee Receivable - Related Party | - | 450,000 | |||||
Inventories (net) | 1,025,104 | 987,853 | |||||
Other Current Assets | 163,890 | 67,898 | |||||
Total Current Assets | 3,369,382 | 2,479,496 | |||||
Non-Current Assets | |||||||
Property, plant and equipment, net | 267,321 | 240,014 | |||||
Intangible assets, net | 2,434,637 | 2,693,209 | |||||
Other Assets | 4,282 | 4,572 | |||||
Total Non-Current Assets | 2,706,240 | 2,937,795 | |||||
Total Assets | $ 6,075,622 | $ 5,417,291 | |||||
LIABILITIES | |||||||
Current Liabilities | |||||||
Trade and Other Payables | $ 1,000,413 | $ 1,082,504 | |||||
Other Payables - Related Party | 6,586 | 58,542 | |||||
Short-Term Notes Payable - Related Party | 307,500 | - | |||||
Deferred Revenue - Related Party | 638,889 | 972,222 | |||||
Total Current Liabilities | 1,953,388 | 2,113,268 | |||||
Total Liabilities | 1,953,388 | 2,113,268 | |||||
EQUITY | |||||||
Convertible Preferred Stock, No par value, | |||||||
50,000,000 shares authorized, 0 and 10,000,000 | |||||||
shares issued and outstanding as of December | |||||||
31, 2013 and 2012 | - | 225,000 | |||||
Common Stock, No par value, 500,000,000 | |||||||
shares authorized, 2,167,837 and 1,278,948 | |||||||
issued and outstanding as of December 31, 2013 | |||||||
and 2012 | 85,843,360 | 83,273,376 | |||||
Accumulated Deficit | (81,721,126) | (80,194,353) | |||||
Total Equity | 4,122,234 | 3,304,023 | |||||
Total Liabilities and Equity | $ 6,075,622 | $ 5,417,291 | |||||
Consolidated Statements of Operations |
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Years ended December 31, 2013 and 2012 |
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| |||||||
| |||||||
2013 | 2012 |
| |||||
Revenues: |
| ||||||
Product Revenue | $ 1,325,178 | $ 1,523,650 |
| ||||
Product Revenue - Related party | 1,719,340 | 12,673 |
| ||||
License Revenue | 200,000 | - |
| ||||
License Revenue - Related party | 333,333 | 27,778 |
| ||||
Total Revenue | 3,577,851 | 1,564,101 |
| ||||
Cost of Sales: |
| ||||||
Product Cost of Sales | (1,913,844) | (1,007,951) |
| ||||
| |||||||
Gross Profit | 1,664,007 | 556,150 |
| ||||
| |||||||
Administrative Expenses | 1,095,950 | 1,009,803 |
| ||||
Administrative Expenses - Related parties | 428,676 | 483,904 |
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Sales and Marketing Expenses | 684,720 | 638,732 |
| ||||
Research and Development Expenses | 1,006,800 | 900,380 |
| ||||
Amortization of Non-Current Assets | 258,572 | 258,572 |
| ||||
| |||||||
Loss from Operations | (1,810,711) | (2,735,241) |
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| |||||||
Other Income/Expenses |
| ||||||
Foreign Currency Transaction (Income)/Expense | 57 | (6,859) |
| ||||
Gain on sale of equity investment - Related party | (99,710) | - |
| ||||
Gain from demutualization of insurance carrier | (91,286) | - |
| ||||
Other Income | (92,999) | (3,154) |
| ||||
Total Other income | (283,938) | (10,013) |
| ||||
| |||||||
Loss Before Income Taxes | (1,526,773) | (2,725,228) |
| ||||
| |||||||
Income Tax Benefit | - | 167,408 |
| ||||
| |||||||
Net Loss | $ (1,526,773) | $ (2,557,820) |
| ||||
| |||||||
Basic & diluted loss per common share | $ (0.96) | $ (2.24) |
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| |||||||
Weighted average basic & diluted common |
| ||||||
shares outstanding | 1,596,722 | 1,143,058 |
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AKERS BIOSCIENCES, INC. AND SUBSIDIARIES | |||
Consolidated Cash Flow Statements | |||
Years ended December 31, 2013 and 2012 | |||
2013 | 2012 | ||
Cash flows from operating activities | |||
Net loss for the year | $ (1,526,773) | $ (2,557,820) | |
Adjustments to reconcile net loss to net cash used by | |||
operating activities: | |||
Gain from demutualization of insurer | (91,286) | - | |
Gain on sale of equity investment - related party | (99,710) | - | |
Reversal of old trade payables | (91,905) | - | |
Depreciation and amortization of non-current assets | 354,397 | 371,676 | |
Provisions for bad debts | - | 9,047 | |
Provision for inventory obsolesence | - | 32,000 | |
Write-off of note receivable | - | 148,900 | |
Changes in assets and liabilities | |||
(Increase)/Decrease in trade receivables | (17,191) | 95,287 | |
(Increase)/decrease in trade receivables - related party | (1,199,375) | 11,829 | |
Decrease in other receivables | 559 | 258,939 | |
Decrease in license fees receivable - related party | 450,000 | - | |
Increase in inventories | (37,251) | (334,178) | |
(Increase)/decrease in other assets | (95,992) | 16,669 | |
Increase in trade and other payables | 116,739 | 281,422 | |
Increase/(decrease) in other payables - related party | (51,957) | 37,917 | |
Increase/(decrease) in legal settlement liabilities | (106,924) | 106,924 | |
Increase/(decrease) in deferred revenue - related party | (333,333) | 522,222 | |
Net cash used in operating activities | (2,730,002) | (999,166) | |
Cash flows from investing activities | |||
Purchases of property, plant and equipment | (123,132) | (11,685) | |
Proceeds from sale of equity investment - related party | 100,000 | - | |
Proceeds from demutualization of insurance carrier | 91,286 | - | |
Net cash provided from/(used in) investing activities | 68,154 | (11,685) | |
Cash flows from financing activities | |||
Proceeds from note receivable - related party for Series A Convertible | |||
Preferred Stock | 225,000 | - | |
Proceeds from short-term note payable - related party | 307,500 | - | |
Proceeds from issuance of common stock | 1,599,960 | 451,068 | |
Net cash provided by financing activities | 2,132,460 | 451,068 | |
Net decrease in cash and cash equivalents | (529,388) | (559,783) | |
Cash and cash equivalents at beginning of year | 633,022 | 1,192,805 | |
Cash and cash equivalents at end of year | $ 103,634 | $ 633,022 | |
Supplemental Disclosure of Cash Flow Information | |||
Non-cash financing activities | |||
Other receivable for proceeds of London Private Placement | $ 745,024 | $ - | |
Issuance of convertible preferred stock for note receivable - related party | $ - | $ 225,000 | |
License fee receivable - related party included in deferred revenue - related party | $ - | $ 450,000 | |
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES | |||||
Consolidated Statement of Changes in Stockholder's Equity | |||||
Years ended December 31, 2013 and 2012 | |||||
Convertible | |||||
Preferred | Common | Accumulated | Total | ||
Stock | Stock | Deficit | Equity | ||
Balance at December 31, 2011 | $ - | $ 82,822,308 | $ (77,636,533) | $ 5,185,775 | |
Net loss for the year | - | - | (2,557,820) | (2,557,820) | |
Issuance of shares | 225,000 | 451,068 | - | 676,068 | |
Balance at December 31, 2012 | 225,000 | 83,273,376 | (80,194,353) | 3,304,023 | |
Net loss for the year | - | - | (1,526,773) | (1,526,773) | |
Conversion of Series A Preferred Shares | (225,000) | 225,000 | - | - | |
Issuance of shares, net of offering costs | - | 2,344,984 | - | 2,344,984 | |
Balance at December 31, 2013 | $ - | $ 85,843,360 | $ (81,721,126) | $ 4,122,234 | |
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES | ||||
Reconcilement of IFRS to U.S. GAAP | ||||
December 31, 2013 and 2012 | ||||
2013 | 2012 | |||
Reconciliation of net loss | ||||
Loss attributable to equity shareholders in accordance with IFRS | 1 | $ (971,810) | $ (2,540,801) | |
U.S. GAAP adjustments | ||||
a) Capitalized development costs | 1 | (801,300) | (183,225) | |
b) Amortization of intangibles | 1 | 246,337 | 166,206 | |
Net Loss in accordance with U.S. GAAP | $ (1,526,773) | $ (2,557,820) | ||
Basic & diluted loss per common share | $ (0.96) | $ (2.24) | ||
Weighted average basic & diluted common shares outstanding | 1,596,722 | 1,143,058 | ||
Reconciliation of shareholders' equity | ||||
Equity attributable to shareholders in accordance with IFRS | 1 | $ 5,676,843 | $ 4,303,669 | |
U.S. GAAP adjustments |
| |||
a) U.S. GAAP adjustments attributable to prior years | 1 | (999,646) | (982,627) | |
b) Capitalized development costs | 1 | (801,300) | (183,225) | |
c) Amortization of intangibles | 1 | 246,337 | 166,206 | |
Shareholder equity in accordance with U.S. GAAP | $ 4,122,234 | $ 3,304,023 | ||
1 The values reported are unaudited | ||||