THOROFARE, NJ--(Marketwired - Mar 30, 2017) - Akers Biosciences, Inc. (NASDAQ: AKER) (AIM: AKR.L), ("Akers Bio" or the "Company"), a developer of rapid health information technologies, announces preliminary unaudited earnings highlights for the fiscal year ended December 31, 2016.
The Company will apply for a 15-day extension to file the Form 10-K containing its 2016 earnings so as to allow additional time for the Company and its auditors to incorporate data from certain subsequent events and complete the Company's management discussion and analysis. Accordingly, there will be no conference call on Friday, March 31, 2017, as previously announced. The details of a rescheduled conference call and earnings publication date will be notified in the near future.
2016 Financial Highlights:
- Total revenue up 40% to $2,960,912 (2015: $2,115,050)
- Growth driven by 85% increase in sales of flagship heparin allergy test to $2,557,148 (2015: $1,391,017)
- Total product sales of $2,957,162 exceeded 2015 sum by approximately $1.2 million or 65%.
- Gross profit margin increased to 63% (2015: 55%) resulting in gross income of $1,877,825 (2015: $1,164,258)
- Significant reductions in major expense areas:
- General and Administrative expenses reduced by 51% to $3,008,811 (2015: $6,193,125)
- Sales and Marketing expenses reduced by 16% to $2,137,282 (2015: $2,543,286)
- Research and Development expenses reduced by 15% to $1,188,868 (2015: $1,406,895)
- Reversal of an allowance for bad debts of $1,299,609 in exchange for inventory and a prepaid royalty
- These factors contributed to a markedly reduced net loss attributable to shareholders of $3,303,538, down 65% compared to 2015 (2015: $9,311,913)
- Cash and marketable securities at December 31, 2016 of $122,701 (2015: $4,427,163) bolstered by net proceeds of $1,736,213 from January 13, 2017 public offering
- As at December 31, 2016, current assets totaled $3,186,944, current liabilities totaled $1,697,430 and working capital was $1,489,514
2016 Operational Highlights:
- Successfully implemented significant price increase for flagship PIFA Heparin PF/4 Rapid Assay products
- Sales of PIFA Heparin PF/4 Rapid Assay products to U.S. hospitals enjoyed their strongest ever half year period during H2 2016, providing momentum moving into the current year
- PIFA Heparin PF/4 Rapid Assay products recorded sales of $493,850 to China in 2016 -- further orders are anticipated when pricing approvals are received in key provinces
- Three-year agreement signed with GNHYA Services, a group purchasing organization affiliated with Greater New York Hospital Association (GNYHA), to introduce PIFA Heparin PF/4 Rapid Assay products across GNYHA's network of over 300 member hospitals and health systems
- Exclusive U.S. distribution agreement signed for rapid cholesterol self-test with First Check Diagnostics, LLC for sale under their "First Check" brand, which is sold in major retailers including CVS, Rite Aid, Target, Kmart, Meijer, Giant Eagle, Stop & Shop, Giant and ShopKo (initial order received after year-end)
- Completed highly successful clinical trials for rapid breath test for diabetic ketoacidosis (BreathScan® DKA) and rapid blood test for chlamydia (PIFA/Chlamydia Rapid Assay); as well as a highly successful clinical study for rapid breath test for oxidative stress (BreathScan OxiCheck™)
- Overall agreement between the BreathScan® DKA test and gold standard hospital blood test was 92%
- Overall agreement between the PIFA/Chlamydia Rapid Assay and the reference laboratory method was 96% in patient populations of acute infection and historical exposure
- Overall agreement between OxiChek™ and the standard reference laboratory blood testing method (TBARS) was 99.5%
- Strengthened commercial team with the appointments of Doug Carrara and Tony Saporito in senior sales and marketing roles following the appointment of new CEO, John J. Gormally in November 2015
- Reshaped U.S. sales strategy for PIFA Heparin PF/4 Rapid Assay products to target large integrated delivery networks which require fewer, but more experienced, sales personnel
John J. Gormally, Chief Executive Officer of Akers Bio, commented:
"We continued to see strong evidence during 2016 of growing demand for our PIFA Heparin PF/4 Rapid Assay products. This is reflected in an uplift in sales for these products of 85% in the period. We believe it is a notable achievement to have successfully implemented our evidence-based outcome proposition that supported our pricing for our PIFA Heparin PF/4 Rapid Assay within the market. This fact speaks volumes about our branded flagship offering that has the ability to provide significant savings for hospitals through the implementation of our test for platelet factor four antibodies.
Our strategy to focus on integrated delivery networks and group purchasing organizations in the U.S. is gaining traction, as demonstrated in the three-year agreement announced with the GNYHA Services in December 2016 to introduce our tests across their network of over 300 member hospitals and health systems.
Furthermore, we believe that once additional regulatory hurdles in China are complete, Akers Bio will be able to release further product there as demand grows, creating a very attractive non-U.S. revenue stream for PIFA Heparin PF/4 Rapid Assay products.
As revenues increase, our cost base is decreasing allowing for cash flow breakeven to move into our sights. We have recorded material reductions in all key areas of expense. This is reflected in a significant reduction in the loss from operations, down from approximately $9.3 million in 2015 to approximately $3.3 million in 2016. The impact of this is a markedly reduced loss attributable to shareholders of approximately $3.3 million, down 65%.
I am excited about the future not only for our currently commercialized tests -- in particular PIFA Heparin PF/4 Rapid Assay and Tri-Cholesterol "Check" -- but also for our near-term pipeline which is underpinned by hugely successful clinical trials and studies completed during 2016 for rapid tests for cholesterol, diabetic ketoacidosis and oxidative stress. The success of these trials reinforces the value we believe lies within our proprietary platform technologies. Each of the markets targeted by our pipeline of new tests is significant and we believe Akers Bio's new generation of testing technology will greatly enhance the patient experience while reducing costs for the healthcare system.
I expect 2017 to be characterized by further growth in our flagship PIFA Heparin PF/4 Rapid Assay product line, sales of our rapid cholesterol test direct to consumers through major U.S. retailers under the "First Check" brand, growing sales from our new generation of app-connected wellness products and, subject to regulatory approvals, the launch into the market of the first rapid blood test for chlamydia and a breath test for nutritional ketosis or fat burning.
We look forward to publishing our Form 10-K earnings statement in due course."
About Akers Biosciences, Inc.
Akers Bio develops, manufactures, and supplies rapid screening and testing products designed to deliver quicker and more cost-effective healthcare information to healthcare providers and consumers. 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 product 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.akersbio.com. Follow us on Twitter @AkersBio.
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.