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Final Results

11th Apr 2017 07:00

RNS Number : 1288C
Akers Biosciences, Inc.
11 April 2017
 

April 11, 2017

This announcement contains inside information

Akers Biosciences, Inc.

Financial Results for the Year Ended December 31, 2016

Sales of Flagship Rapid HIT Test +85% over prior year

Akers Biosciences, Inc. (NASDAQ: AKER) (AIM: AKR.L), ("Akers", "Akers Bio" or the "Company"), a developer of rapid health information technologies, reports its financial results for the fiscal year ended December 31, 2016. A Form 10-K containing the full financial statements will be available for viewing later today on the Company's website at www.akersbio.com or www.sec.gov.

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 $2,577,148 (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:

o General and Administrative expenses reduced by 25% to $3,008,811 (2015: $4,029,516)

o Sales and Marketing expenses reduced by 16% to $2,137,282 (2015: $2,543,286)

o 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 (this is now accounted for separately from the General and Administrative expense)

· 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 approximately $1.7 million from a public offering and $1.8 million from a private placement on January 13 and March 31, 2017 respectively

· As of April 5, 2017, the Company had cash and marketable securities of approximately $2.3 million

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™)

o Overall agreement between the BreathScan® DKA test and gold standard hospital blood test was 92%

o Overall agreement between the PIFA/Chlamydia Rapid Assay and the reference laboratory method was 96% in patient populations of acute infection and historical exposure

o 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 

o 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 

Chief Executive Officer's Review

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.

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.

Outlook

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.

John J. Gormally

Chief Executive Officer

 

Conference Call

Akers Bio will hold a conference call today at 2:00 p.m. BST (9:00 a.m. Eastern Time) to discuss its 2016 financial results. Management will be available during a question-and-answer session.

 

To participate in the call from outside the U.S., please dial 1-719-325-4933 approximately 10 minutes prior to the scheduled start time. Callers from within the U.S. should dial 1-877-857-6150. The Conference ID is 2794993. Interested parties can also listen via a live Internet webcast, which can be found at http://public.viavid.com/index.php?id=123815.

 

A recording of the call will be available in the Investor Center of the Company's website at http://www.akersbio.com/investor-center.

 

For more information:

 

Akers Biosciences, Inc.

John J. Gormally, Chief Executive Officer

Raymond F. Akers, Jr. PhD, Vice Chairman

Tel. +1 856 848 8698

 

finnCap (UK Nominated Adviser and Broker)

Adrian Hargrave / Scott Mathieson (Corporate Finance)

Steve Norcross (Broking)

Tel. +44 (0)20 7220 0500

 

Vigo Communications (Global Public Relations)

Ben Simons / Fiona Henson

Tel. +44 (0)20 7830 9700

Email: [email protected]

 

 

Summary of Statements of Operations for the Year Ended December 31, 2016

 

Results of Operations

Management's Plans and Basis of Presentation

To date, the Company has in large part relied on equity financing to fund its operations, raising $13,101,336, net of expenses, in an initial public offering on the NASDAQ Stock Exchange in 2014. The Company continues to experience recurring losses and negative cash flows from operations. Management's strategic plans include the following:

· continuing to advance the development and commercialization of the Company's products, especially those that utilize MPC Biosensor, PIFA and seraSTAT technologies;

 

· continuing to strengthen and forge domestic and international relationships with well-established sales organizations with strong distribution channels in specific target markets for both our currently marketed and emerging products;

 

· establishing clinical protocols that support regulatory submissions and publication of data within peer-reviewed journals; and

 

· continuing to monitor and implement cost control initiatives to conserve cash.

Despite our plans, the Company expects to continue to incur losses from operations for the near-term and these losses could be significant for the following reasons:

· some of Akers' distribution partnerships have been recently established or are in the process of being initiated and, therefore, consistent and historical ordering patterns have not been instituted;

 

· the Company continues to incur expenses related to the initial commercialization and marketing activities for its Wellness products, and product development (research, clinical trials, regulatory tasks) costs for its emerging products, Breath PulmoHealth "Check" rapid assays and PIFA PLUSS® Infectious Disease point-of-care tests); and

 

· to expand the use of its clinical laboratory products, the Company may need to invest in additional marketing support programs to increase brand awareness.

At December 31, 2016, Akers had cash of $72,700, working capital of $1,489,514, stockholders' equity of $3,387,677 and an accumulated deficit of $97,479,537. The Company believes that its current working capital position will be sufficient to meet its estimated cash needs for at least the next twelve months.

The fair value of the Company's investments in marketable securities as of December 31, 2016 was $50,001 (2015: $4,025,104). The Company restricts its investments to Level I and Level II securities and maturities generally range up to three years. Securities are evaluated with an emphasis on minimizing risk while achieving reasonable rates of return on the investment. These marketable securities are a key component of the Company's cash management strategy and as such are monitored regularly.

If the Company does not obtain additional capital as needed, the Company would potentially be required to reduce the scope of its research and development activities. The Company is closely monitoring its cash balances, cash needs and expense levels.

Revenue

 

The Company's total revenue for the year ended December 31, 2016 was $2,960,912, a 40% increase compared to the same period in 2015. The table below presents a summary of our sales by product line:

 

 

 

Year Ended

 

 

Year Ended

 

 

Percent

 

Product Line

 

December 31, 2016

 

 

December 31, 2015

 

 

Change

 

MicroParticle Catalyzed Biosensor ("MPC")

 

$

282,516

 

 

$

296,328

 

 

 

(5

)%

Particle ImmunoFiltration Assay ("PIFA")

 

 

2,577,148

 

 

 

1,391,017

 

 

 

85

%

Other

 

 

97,499

 

 

 

107,149

 

 

 

(9

)%

Product Revenue Total

 

$

2,957,162

 

 

$

1,794,494

 

 

 

65

%

License Fees

 

 

3,750

 

 

 

320,556

 

 

 

(99

)%

Total Revenue

 

$

2,960,912

 

 

$

2,115,050

 

 

 

40

%

 

Product revenue increased by 65% to $2,957,162 (2015: $1,794,494) during the year ended December 31, 2016 driven primarily by a price increase for our PIFA Heparin/PF4 Rapid Assay products. Licensing revenue declined by 99% to $3,750 ($320,556), the result of the loss of licensing revenue from ChubeWorkx as a result of the termination of the distribution agreement for the Company's BreathScan Alcohol Breathalyzers that occurred in the second quarter of 2015.

 

The Company's MPC product sales declined by 5% to $282,516 (2015: $296,328) during the year ended December 31, 2016. A distributor's initial stocking order of approximately $144,000 for the Company's BreathScan Alcohol Breathalyzer products in Great Britain was included for the year ended December 31, 2015 but not repeated in 2016. Net of this significant order, MPC product sales increased 85% year-over-year. The Company's new BreathScan Lync and BreathScan OxiChek™ products and renewed interest in the Company's BreathScan Alcohol Breathalyzers, both domestically and internationally, contributed to the increase for the year ended December 31, 2016.

 

The Company's total PIFA sales increased during the year ended December 31, 2016 by 85% to $2,577,148 (2015: $1,391,017). The increase is due primarily to two events; first, the implementation of a significant price increase for the product line and second, the fulfillment during the year of approximately 20% of the $2.5 million order from Novotek, our exclusive distributor for PIFA Heparin/PF4 Rapid Assay products in the People's Republic of China.

 

The Company's dedicated technical sales account executives are supporting over 300 sales representatives of Akers' U.S. distribution partners, Cardinal Health ("Cardinal Health"), Fisher HealthCare ("Fisher Healthcare") and Typenex Medical, LLC ("Typenex"). The Company's relationship-building initiative with our partners has delivered a measurable increase in product trials and adoptions. Domestic sales for the year ended December 31, 2016 of our distributors, Cardinal Health and Fisher HealthCare, accounted for $1,820,186 of the total PIFA Heparin/PF4 Rapid Assay sales as compared to $1,213,006 for the same period of 2015 and individually represented 37% and 22% of such sales, respectively.

 

The Company's international sales of its PIFA Heparin/PF4 Rapid Assay products totaled $493,850 (2015: $-) during the year ended December 31, 2016 primarily as a result of the partial fulfillment of a $2.5 million order from NovoTek. Although the product has been approved for use in China by the China Food and Drug Administration, each province in which it is sold must establish reimbursement rates for the medical facilities that utilize the test. NovoTek is diligently working through this provincial approval process and is projecting reimbursement rate approvals in several provinces during 2017 which is expected to allow for the release of and payment for further products in line with user demand.

 

Other operating revenue decreased by 9% to $97,499 (2015: $107,149) for the year ended December 31, 2016 due in a major part to a decline in the sale of miscellaneous components to $42,570 (2015: $50,612).

 

The Company's exclusive License and Supply Agreement with ChubeWorkx Guernsey Limited ("ChubeWorkx") for the Company's proprietary breathalyzer product was cancelled by both parties on May 7, 2015. As a result of this event, and per the terms of the original agreement, the Company recognized the remaining $166,667 of deferred revenue in the statement of operations and comprehensive income for the year ended December 31, 2015. The Company is now able to solicit business outside the United States for its alcohol breathalyzer products and has begun to receive and ship orders.

 

Licensing fee revenue declined to $3,750 (2015: $320,556). The decline is associated with the cancellation of the Company's exclusive License and Supply Agreement with ChubeWorkx as described above.

 

Cost of sales for the year ended December 31, 2016 totaled $1,083,087 (2015: $950,792) on the increased revenue during the year ended December 31, 2016. Direct cost of sales decreased to 26% (2015: 43%) and indirect cost of sales decreased to 21% (2015: 24%) of product revenue for year ended December 31, 2016. Overall, cost of sales, as a percentage of product revenue, was 37% and 53% for the years ended December 31, 2016 and 2015.

 

Direct costs associated with the MPC products remained constant at 30% (2015: 30%) and PIFA products decreased to 9% (2015: 11%) related to the increased use of sub-contractors for the assembly of components.

 

Indirect cost of sales for the year ended December 31, 2016 totaled $634,848 (2015: $425,609) which represented 21% (2015: 24%) of product revenue. Costs associated with personnel, consumable supplies other general production declined while a project to identify and discard expired, stale and obsolete inventory resulted in a significant increase in expenses related to slippage and obsolescence. In addition, the percentage change is affected by the fixed cost nature of many of the components in this category.

 

Akers' gross profit margin, as a percentage of revenue, increased to 63% for the year ended December 31, 2016 as compared to 55% in 2015 for the reasons described above.

 

General and Administrative Expenses

 

General and administrative expenses in the year ended December 31, 2016 totaled $3,008,811, which was a 25% decrease as compared to $4,029,516 for the year ended December 31, 2015. The table below summarizes our general and administrative expenses for the years ended December 31, 2016 and 2015 as well as the percentage of change year-over-year:

 

 

 

Year Ended

 

 

Year Ended

 

 

Percent

 

Description

 

December 31, 2016

 

 

December 31, 2015

 

 

Change

 

Personnel Costs

 

$

886,294

 

 

$

902,431

 

 

 

(2

)%

Professional Service Costs

 

 

885,746

 

 

 

1,233,126

 

 

 

(28

)%

Stock Market & Investor Relations Costs

 

 

441,453

 

 

 

572,161

 

 

 

(23

)%

Other General and Administrative Costs

 

 

795,318

 

 

 

1,321,798

 

 

 

(40

)%

Total General and Administrative Costs

 

$

3,008,811

 

 

$

4,029,516

 

 

 

(25

)%

 

Several specific categories of expense decreased significantly during the year ended December 31, 2016. Below is a summary of these categories:

 

 

 

Year Ended

 

 

Year Ended

 

 

Percent

 

Description

 

December 31, 2016

 

 

December 31, 2015

 

 

Change

 

Professional Services

 

$

885,746

 

 

$

1,233,136

 

 

 

(28

)%

Stock Market & Investor Relations

 

 

441,453

 

 

 

572,161

 

 

 

(23

)%

Travel Costs

 

 

118,980

 

 

 

268,201

 

 

 

(56

)%

Total

 

$

1,446,179

 

 

$

2,073,488

 

 

 

(30

)%

 

Professional services included significant decreases in employment agency fees ($409 (2015: $237,553)), general consulting services ($73,405 (2015: $125,168)) and legal fees ($613,159 (2015 $736,745)) which were offset by an increase in accounting and audit expenses ($182,396 ((2015: $133,660)) during the year ended December 31, 2016.

 

The Company recognized cost savings in all of its stock market and investor relations categories. These include consulting, investor relations, stock exchange fees and transfer agent fees.

 

Travel to China in support of NovoTek and Hainan Savy-Akers Biosciences ("Savy-Akers"), our Chinese joint venture, were consolidated resulting in two (2) extended trips during the year ended December 31, 2016. During 2015, the Company made several trips to assist NovoTek in gaining government approvals and developing the market for the Company's PIFA Heparin/PF4 Rapid Assay product.

 

Sales and Marketing Expenses

 

Sales and marketing expenses in the year ended December 31, 2016 totaled $2,137,282, which was a 16% decrease as compared to $2,543,286 for the year ended 2015. The table below summarizes our sales and marketing expenses for the years ended December 31, 2016 and 2015 as well as the percentage of change year-over-year:

 

 

 

Year Ended

 

 

Year Ended

 

 

Percent

 

Description

 

December 31, 2016

 

 

December 31, 2015

 

 

Change

 

Personnel Costs

 

$

1,129,722

 

 

$

1,359,460

 

 

 

(17

)%

Professional Service Costs

 

 

441,632

 

 

 

751,220

 

 

 

(41

)%

Royalties and Commission Costs

 

 

225,159

 

 

 

158,347

 

 

 

42

%

Other Sales and Marketing Costs

 

 

340,769

 

 

 

274,259

 

 

 

24

%

Total Sales and Marketing Costs

 

$

2,137,282

 

 

$

2,543,286

 

 

 

(16

)%

 

Personnel costs decreased in the year ended December 31, 2016 due to a revision of the sales strategy to target large integrated delivery networks ("IDNs") which require fewer, but more experienced, area business directors. This was accomplished by replacing the executive sales staff with a Vice President for Global Marketing and a Vice President of United States Sales. The strategy established five (5) areas, each with an Area Business Director ("ABDs"), however, attrition during the year resulted in the loss of three (3) ABDs and the strategy was revised to use pay-for-performance based Independent Manufacturing Representatives ("IMRs") in-lieu of replacing staff.

 

The decrease in the use of contracted marketing services firms ($51,246 (2015: $225,064)) and general sales consultants ($351,459 (2015: $525,938)) resulted in a 41% decrease in professional service costs. The Company has refocused its sales and marketing strategy, concentrating on the development of relationships with Independent Manufacturing Representatives that are paid for performance versus the use of contracted sales groups paid fixed monthly fees.

 

Royalty and commission costs increased as a result of outside sales commissions ($71,305 (2015: $66,436)), due to increased sales of the PIFA products, both domestically and internationally, and royalty expenses ($153,854 (2015: $91,910)) during the year ended December 31, 2016.

 

Other sales and marketing costs increased primarily due to technology ($53,312 (2015: $20,261)), sponsorships ($10,500 (2015: $-)) and travel ($182,420 (2015: $145,688)) expenses and was partially offset by decreases in advertising and promotional materials expenses ($5,080 (2015: $42,323)).

Research and Development

 

Research and development expenses in the year ended December 31, 2016 totaled $1,188,868, which was a 15% decrease as compared to $1,406,895 for the year ended 2015. The table below summarizes our research and development expenses for the years ended December 31, 2016 and 2015 as well as the percentage of change year-over-year:

 

 

 

Year Ended

 

 

Year Ended

 

 

Percent

 

Description

 

December 31, 2016

 

 

December 31, 2015

 

 

Change

 

Personnel Costs

 

$

745,326

 

 

$

699,595

 

 

 

7

%

Professional Service Costs

 

 

113,807

 

 

 

504,800

 

 

 

(77

)%

Clinical Trial Costs

 

 

160,405

 

 

 

41,586

 

 

 

286

%

Other Research and Development Costs

 

 

169,330

 

 

 

160,914

 

 

 

5

%

Total Research and Development Costs

 

$

1,188,868

 

 

$

1,406,895

 

 

 

(15

)%

 

Personnel costs increased 7% during the year ended December 31, 2016 as compared to the same period of 2015 as a result of the transfer to this department of Dr. Akers from the General and Administrative department effective April 25, 2016 and the employment of a new Director of Quality Assurance.

 

The Company had two clinical trials in-process during the year ended December 31, 2016 in respect of the Company's rapid chlamydia assay and Diabetic Ketoacidosis breath test resulting in a significant increase in costs associated with these programs. The trials are collecting data to support submissions to the U.S. Food and Drug Administration for 510(k) approvals and to support the clinical effectiveness of the products.

 

Professional service costs declined 77% during the year ended December 31, 2016. During the year ended December 31, 2015, the Company was expending funds for the engineering and design of the BreathScan Lync™ reader and cartridge being used with the new Health and Wellness MPC products. These design projects are now complete.

 

Increase in supplies ($52,317 (2015: $45,235)), seminars and professional development ($26,849 (2015: $1,980)) waste disposal ($19,322 (2015: $15,082)) and travel expenses ($29,561 ($2015: 9,739) was offset by a reduction in the utilization of inventory resources for development and testing ($8,595 (2015: $46,590)) that resulted in an increase of 5% for other research and development costs during the year ended December 31, 2016.

 

The following table illustrates research and development costs by project for the years ended December 31, 2016 and 2015, respectively.

 

 

 

2016

 

 

2015

 

Asthma/pH

 

$

-

 

 

$

4,917

 

BreathScan

 

 

1,483

 

 

 

110,609

 

Chlamydia Trachomatis

 

 

35,808

 

 

 

134,362

 

CHUBE

 

 

-

 

 

 

397

 

H/PF4

 

 

104,436

 

 

 

98,876

 

HIV

 

 

-

 

 

 

150,543

 

Diabetic Ketoacidosis

 

 

3,098

 

 

 

72,757

 

KetoChek / OxiChek

 

 

584,585

 

 

 

252,462

 

Lithium

 

 

-

 

 

 

41,086

 

Metron

 

 

5,832

 

 

 

77,796

 

Other Projects

 

 

144,457

 

 

 

156,379

 

Pulmo Health

 

 

22,069

 

 

 

18,283

 

Sonicator OQ

 

 

-

 

 

 

886

 

Troponin

 

 

-

 

 

 

127,095

 

Tri Cholesterol

 

 

281,884

 

 

 

96,271

 

VIVO

 

 

5,216

 

 

 

64,176

 

Total R&D Expenses:

 

$

1,188,868

 

 

$

1,406,895

 

 

(Reversal of Allowance for) Bad Debt Expense - Related Party

 

The Company established an allowance for doubtful accounts for $1,299,609 for a note receivable - related party as a result of an internal assessment indicating a high level of risk of collectability as of December 31, 2015. In August 2016, the two companies reached a settlement agreement which included recovery for the value of the note receivable. As a result, the allowance for doubtful accounts was reversed during the year ended December 31, 2016.

 

Other Income and Expense

 

Other income and expense decreased for the year ended December 31, 2016 to $25,097 from $100,973 for the same period in 2015. The table below summarizes our other income and expenses for the years ended December 31, 2016 and 2015 as well as the percentage of change year-over-year:

 

 

 

Year Ended

 

 

Year Ended

 

 

Percent

 

Description

 

December 31, 2016

 

 

December 31, 2015

 

 

Change

 

Currency Translation (Gain)/Loss

 

$

(3,398

)

 

$

7,535

 

 

 

145

%

Dividend on Series A Preferred Stock

 

 

-

 

 

 

-

 

 

 

-

%

Investment (Gain)/Loss

 

 

85

 

 

 

6,512

 

 

 

99

%

Interest and Dividends

 

 

(21,784

)

 

 

(108,968

)

 

 

(80

)%

Other Extraordinary Income

 

 

-

 

 

 

(6,052

)

 

 

(100

)%

Total Other (Income) and Expense

 

$

(25,097

)

 

$

(100,973

)

 

 

(75

)%

 

Income Taxes 

 

During 2015, the Company was approved by the State of New Jersey to sell a portion of its state tax benefits that existed as of December 31, 2014, pursuant to the Technology Tax Certificate Transfer Program. The Company received net proceeds of $269,344 for the year ended December 31, 2015 as a result of the sale of the tax benefits. The Company, anticipating profitability for 2016 at the June 30, 2016 filing deadline, did not participate in the program during the year ended December 31, 2016.

 

As of December 31, 2016 and 2015, the Company had Federal net operating loss carry forwards of approximately $60,100,000 and $58,000,000, respectively, expiring through the year ending December 31, 2036. As of December 31, 2016 and 2015, the Company had New Jersey state net operating loss carry forwards of approximately $9,400,000 and $7,200,000, respectively, expiring the year ending December 31, 2023.

 

The principal components of deferred tax assets and valuation allowance as of December 31, 2016 and December 31, 2015 are as follows:

 

Deferred Tax Assets

 

 

 

Year Ended December 31,

 

 

 

2016

 

 

2015

 

Reserves and other

 

$

865,000

 

 

$

2,506,000

 

Net operating loss carry-forwards

 

$

21,618,000

 

 

$

20,728,000

 

Valuation Allowance

 

$

(22,483,000

)

 

$

(23,234,000

)

Net

 

$

-

 

 

$

-

 

 

The valuation allowance for deferred tax assets as of December 31, 2016 and 2015 was $22,483,000 and $23,234,000. The change in the total valuation for the years ended December 31, 2016 and 2015 were a decrease of $751,000 and an increases of $3,795,104. In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which the net operating losses and temporary differences become deductible. Management considered projected future taxable income and tax planning strategies in making this assessment. The value of the deferred tax assets was fully offset by a valuation allowance, due to the current uncertainty of the future realization of the deferred tax assets.

 

The reconciliation of income taxes using the statutory U.S. income tax rate and the benefit from income taxes for the years ended December 31, 2016 and December 31, 2015 are as follows.

 

Tax Rates & Benefits

 

 

 

Year Ended December 31,

 

 

 

2016

 

 

2015

 

Statutory U.S. Federal Income Tax Rate

 

 

(35.0

)%

 

 

(35.0

)%

New Jersey State income taxes, net of U.S.

 

 

 

 

 

 

 

 

Federal tax effect

 

 

(6.0

)%

 

 

(6.0

)%

Benefit from sale of New Jersey NOL

 

 

0.0

%

 

 

(2.9

)%

Change in Valuation Allowance

 

 

41.0

%

 

 

41.0

%

Net

 

 

0.0

%

 

 

(2.9

)%

 

Liquidity and Capital Resources

 

For the years ended December 31, 2016 and 2015, the Company generated a net loss attributable to shareholders of $3,303,538 and $9,311,913, respectively. As of December 31, 2016 and 2015, the Company has an accumulated deficit of $97,479,537 and $94,175,999 and had cash and cash equivalents totaling $72,700 and $402,059, respectively. The Company had marketable securities of $50,001 and $4,025,104 available as of December 31, 2016 and 2015.

 

Currently, our primary focus is to expand the domestic and international distribution of our PIFA Heparin/PF4 rapid assays. The Company continues initial commercialization tasks for METRON and BreathScan Lync, as well as development activities for its PIFA PLUSS® Infectious Disease single-use assays, Breath KetoChek, and Breath PulmoHealth "Check" products, including advancement of the steps required for FDA clearance or CE marking in the EU where necessary.

 

We expect to continue to incur losses from operations for the near-term and these losses could be significant as we incur product development, clinical and regulatory activities, contract consulting and other product development and commercialization related expenses. The Company began implementing the 2017-19 Strategic Plan ("Strat Plan") in January 2017 and management remains confident that the objectives are achievable, however, during the first half of 2017, the Company may encounter limited periods of cash shortages and is proactively working to minimize their impacts on operations. We anticipate maintaining a cash-flow positive position during the next twelve months based upon revenue targets as outlined in the Strat Plan, the results of the private placement offering in March 2017 and the backing of a shareholder, if required. In addition, the Company has initiated discussions with our primary financial institution to establish a line of credit to manage short-term cash fluctuations. The financial statements in the Form 10-K published today do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that might result in the possible inability of the Company to continue as a going concern.

 

We expect that our primary expenditures will be to continue development of PIFA PLUSS® Infectious Disease single-use assays, Breath KetoChek and Breath PulmoHealth "Check" products and enroll patients in clinical trials to support performance claims, generate studies in peer-reviewed journals to support product marketing, and provide data for the FDA 510(k) clearance/CE certifications processes when required. We will also continue to support commercialization and marketing activities of in-line products (PIFA Heparin/PF4 rapid assays, PIFA PLUSS® PF4, breath alcohol detectors, METRON and BreathScan Lync) in the U.S. and internationally. Based upon our experience, clinical trial and related regulatory expenses can be significant costs. Steps to achieve commercialization of emerging products will be an ongoing and evolving process with expected improvements and possible subsequent generations being evaluated for commercialized and emerging tests. Should we be unable to achieve FDA clearance for products that require such regulatory "approval", develop performance characteristics for rapid tests that satisfy market needs, or generate sufficient revenue from commercialized products, we would need to rely on other business or product opportunities to generate revenue and costs that we have incurred for the patents may be deemed impaired. 

 

Capital expenditures, primarily for production, laboratory and facility improvement costs for the year ending December 31, 2016 totaled $123,301 (2015: $112,951). As per the Company's lease agreement, the owner of the facility will be handling the majority of facility upgrades, and we anticipate financing any production and laboratory capital expenditures through working capital.

 

The Company may enter into generally short-term consulting and development agreements primarily for testing services and in connection with clinical trials conducted as part of the Company's development process which may include activities related to the development of technical files for FDA 510(k) clearance submissions. Such commitments at any point in time may be significant but the agreements typically contain cancellation provisions.

 

We lease our manufacturing facility which also contains our administrative offices. Our current lease was executed January 1, 2013 and is effective through December 31, 2019. The Company has leased this property from the current owner since 1997. Due to recent market events that have adversely affected all industries and the economy as a whole, management has placed increased emphasis on monitoring the risks associated with the current environment, particularly the recoverability of current assets, the fair value of assets, and the Company's liquidity. At this point in time, there has not been a material impact on the Company's assets and liquidity. Management will continue to monitor the risks associated with the current environment and their impact on the Company's results.

 

Operating Activities

 

The Company's net cash consumed by operating activities in the year ended December 31, 2016 totaled $4,173,148, which was a 19% decrease as compared to $5,132,343 for the year ended December 31, 2015. The table below summarizes our net cash consumed for the years ended December 31, 2016 and 2015 as well as the percentage of change year-over-year:

 

 

 

Year Ended

 

 

Year Ended

 

 

Percent

 

Description

 

December 31, 2016

 

 

December 31, 2015

 

 

Change

 

Loss from Operations

 

$

(3,303,538

)

 

$

(9,311,913

)

 

 

65

%

Adjustments

 

 

 

 

 

 

 

 

 

 

 

 

Non-Operating Gains

 

 

(1,153,413

)

 

 

(6,052

)

 

 

(18,958

)%

Non-Cash Activities

 

 

414,545

 

 

 

3,331,291

 

 

 

88

%

Cash Used in Operating Activities

 

 

 

 

 

 

 

 

 

 

 

 

Cash Consumed by Operating Activities

 

 

(531,220

)

 

 

(663,010

)

 

 

20

%

Cash Contributed by Operating Activities

 

 

400,478

 

 

 

1,517,341

 

 

 

(74

)%

Net Cash Used in Operating Activities

 

$

(4,173,148

)

 

$

(5,132,343

)

 

 

19

%

 

For the year ended December 31, 2016, cash was consumed by the loss of $3,303,538 and non-operating gains of $1,153,413 offset by a non-cash adjustment of $14,244 for accrued interest and dividends, $286,162 for depreciation, amortization of non-current assets, $32,333 for a reserve for obsolete inventory, $30,153 for amortization of deferred compensation and $51,653 for non-cash share based compensation and services. Decreases in deposits and other receivables ($71,795), prepaid expenses ($17,689), prepaid expenses - related party of ($76,927) and an increase in trade and other payables - related party ($234,067) provided cash. Increases in trade receivables ($138,272), trade receivables - related party ($380), inventories ($187,200) and a decrease in trade and other payables ($205,368) consumed cash. The decrease in net cash used in operating activities was related to improvements to the Company's budgeting process, termination of several consulting agreements and a significant reduction in legal expenses.

 

For the year ended December 31, 2015, cash was consumed by the loss of $9,311,913 and non-operating gains of $6,052 offset by a non-cash adjustment of $4,199 for accrued interest and dividends, $766,471 for depreciation, amortization and impairment of non-current assets, $2,163,609 for allowances for doubtful accounts and $397,012 for non-cash share based compensation and services. Decreases in trade receivables ($513,583), trade receivables - related party ($176,157) and an increase in trade and other payables ($827,601) provided cash. Increases in other receivables ($54,142), inventories ($226,538), other assets ($76,774) and a decrease in deferred revenue - related party ($305,556) consumed cash. The increase in net cash used in operating activities was related to routine changes in operating activities.

 

Financial Statements

Consolidated Balance Sheets

December 31, 2016 and 2015

 

 

 

 

2016

 

 

2015

 

ASSETS

 

 

 

 

 

 

 

 

Current Assets

 

 

 

 

 

 

 

 

Cash

 

$

72,700

 

 

$

402,059

 

Marketable Securities

 

 

50,001

 

 

 

4,025,104

 

Trade Receivables, net

 

 

601,271

 

 

 

609,195

 

Trade Receivables - Related Party, net

 

 

31,892

 

 

 

31,512

 

Deposits and other receivables

 

 

23,782

 

 

 

95,577

 

Inventories, net

 

 

2,036,521

 

 

 

1,131,654

 

Prepaid expenses

 

 

168,277

 

 

 

185,967

 

Prepaid expenses - Related Party

 

 

202,500

 

 

 

-

 

 

 

 

 

 

 

 

 

 

Total Current Assets

 

 

3,186,944

 

 

 

6,481,068

 

 

 

 

 

 

 

 

 

 

Non-Current Assets

 

 

 

 

 

 

 

 

Prepaid expenses - Related Party

 

 

270,183

 

 

 

-

 

Property, Plant and Equipment, net

 

 

259,392

 

 

 

251,145

 

Intangible Assets, net

 

 

1,301,775

 

 

 

1,472,883

 

Other Assets

 

 

66,813

 

 

 

66,813

 

 

 

 

 

 

 

 

 

 

Total Non-Current Assets

 

 

1,898,163

 

 

 

1,790,841

 

 

 

 

 

 

 

 

 

 

Total Assets

 

$

5,085,107

 

 

$

8,271,909

 

 

 

 

 

 

 

 

 

 

LIABILITIES

 

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

 

 

Trade and Other Payables

 

$

1,463,363

 

 

$

1,668,731

 

Trade and Other Payables - Related Party

 

 

234,067

 

 

 

-

 

 

 

 

 

 

 

 

 

 

Total Current Liabilities

 

 

1,697,430

 

 

 

1,668,731

 

 

 

 

 

 

 

 

 

 

Total Liabilities

 

 

1,697,430

 

 

 

1,668,731

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

Convertible Preferred Stock, No par value, 50,000,000 shares authorized, no shares issued and outstanding as of December 31, 2016 and 2015

 

 

-

 

 

 

-

 

Common Stock, No par value, 500,000,000 shares authorized, 5,452,545 and 5,425,045 issued and outstanding as of December 31, 2016 and 2015

 

 

100,891,786

 

 

 

100,785,408

 

Deferred Compensation

 

 

(24,572

)

 

 

-

 

Accumulated Deficit

 

 

(97,479,537

)

 

 

(94,175,999

)

Accumulated Other Comprehensive Income/(Loss)

 

 

-

 

 

 

(6,231

)

 

 

 

 

 

 

 

 

 

Total Stockholders' Equity

 

 

3,387,677

 

 

 

6,603,178

 

 

 

 

 

 

 

 

 

 

Total Liabilities and Stockholders' Equity

 

$

5,085,107

 

 

$

8,271,909

 

 

Consolidated Statements of Operations and Comprehensive Loss

For the years ended December 31, 2016 and 2015

 

 

 

2016

 

 

2015

 

Revenues:

 

 

 

 

 

 

 

 

Product Revenue

 

$

2,956,782

 

 

$

1,757,982

 

Product Revenue - Related party

 

 

380

 

 

 

36,512

 

License Revenue

 

 

3,750

 

 

 

15,000

 

License Revenue - Related party

 

 

-

 

 

 

305,556

 

Total Revenues

 

 

2,960,912

 

 

 

2,115,050

 

Cost of Sales:

 

 

 

 

 

 

 

 

Product Cost of Sales

 

 

(1,083,087

)

 

 

(950,792

)

 

 

 

 

 

 

 

 

 

Gross Income

 

 

1,877,825

 

 

 

1,164,258

 

 

 

 

 

 

 

 

 

 

Administrative Expenses

 

 

3,008,811

 

 

 

4,029,516

 

Sales and Marketing Expenses

 

 

1,983,428

 

 

 

2,543,286

 

Sales and Marketing Expenses - Related Party

 

 

153,854

 

 

 

-

 

Research and Development Expenses

 

 

1,188,868

 

 

 

1,406,895

 

(Reversal of Allowance for) Bad Debt Expenses- Related party

 

 

(1,299,609

)

 

 

2,163,609

 

Impairment of Non-Current Assets

 

 

-

 

 

 

466,476

 

Amortization of Non-Current Assets

 

 

171,108

 

 

 

236,706

 

 

 

 

 

 

 

 

 

 

Loss from Operations

 

 

(3,328,635

)

 

 

(9,682,230

)

 

 

 

 

 

 

 

 

 

Other (Income)/Expenses

 

 

 

 

 

 

 

 

Foreign Currency Transaction (Gain)/Loss

 

 

(3,398

)

 

 

7,535

 

Interest and Dividend Income

 

 

(21,699

)

 

 

(102,456

)

Other Income

 

 

-

 

 

 

(6,052

)

Total Other Income

 

 

(25,097

)

 

 

(100,973

)

 

 

 

 

 

 

 

 

 

Loss Before Income Taxes

 

 

(3,303,538

)

 

 

(9,581,257

)

 

 

 

 

 

 

 

 

 

Income Tax Benefit

 

 

-

 

 

 

269,344

 

 

 

 

 

 

 

 

 

 

Net Loss Attributable to Common Stockholders

 

 

(3,303,538

)

 

 

(9,311,913

)

 

 

 

 

 

 

 

 

 

Other Comprehensive Income

 

 

 

 

 

 

 

 

Net Unrealized Gains on Marketable Securities

 

 

6,231

 

 

 

13,893

 

Total Other Comprehensive Income

 

 

6,231

 

 

 

13,893

 

 

 

 

 

 

 

 

 

 

Comprehensive Loss

 

$

(3,297,307

)

 

$

(9,298,020

)

 

 

 

 

 

 

 

 

 

Basic and diluted loss per common share

 

$

(0.61

)

 

$

(1.81

)

 

 

 

 

 

 

 

 

 

Weighted average basic and diluted common shares outstanding

 

 

5,430,205

 

 

 

5,140,920

 

 

Consolidated Statement of Changes in Stockholder's Equity

For the years ended December 31, 2016 and 2015

 

 

 

Common

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

Shares

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

 

 

 

 

Issued and

 

 

Common

 

 

Deferred

 

 

Accumulated

 

 

Comprehensive

 

 

Total

 

 

 

Outstanding

 

 

Stock

 

 

Compensation

 

 

Deficit

 

 

Income/(Loss)

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2014

 

 

4,954,837

 

 

$

99,691,096

 

 

$

-

 

 

$

(84,864,086

)

 

$

(20,124

)

 

$

14,806,886

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(9,311,913

)

 

 

-

 

 

 

(9,311,913

)

Issuance of restricted common stock to directors & officers

 

 

417,708

 

 

 

977,381

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

977,381

 

Issuance of restricted common stock to key employees

 

 

22,500

 

 

 

27,675

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

27,675

 

Issuance of restricted common stock for services

 

 

30,000

 

 

 

36,900

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

36,900

 

Issuance of non-qualified stock options to key employees

 

 

-

 

 

 

23,636

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

23,636

 

Issuance of non-qualified stock options for services from non-employees

 

 

-

 

 

 

28,720

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

28,720

 

Net unrealized gain on marketable securities

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

13,893

 

 

 

13,893

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2015

 

 

5,425,045

 

 

$

100,785,408

 

 

$

-

 

 

$

(94,175,999

)

 

$

(6,231

)

 

$

6,603,178

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(3,303,538

)

 

 

-

 

 

 

(3,303,538

)

Issuance of restricted common stock to officers

 

 

27,500

 

 

 

54,725

 

 

 

(54,725

)

 

 

-

 

 

 

-

 

 

 

-

 

Amortization of deferred compensation

 

 

-

 

 

 

-

 

 

 

30,153

 

 

 

-

 

 

 

-

 

 

 

30,153

 

Issuance of non-qualified stock options to key employees

 

 

-

 

 

 

27,977

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

27,977

 

Issuance of non-qualified stock options for services from non-employees

 

 

-

 

 

 

23,676

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

23,676

 

Net unrealized gain on marketable securities

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

6,231

 

 

 

6,231

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2016

 

 

5,452,545

 

 

$

100,891,786

 

 

$

(24,572

)

 

$

(97,479,537

)

 

$

-

 

 

$

3,387,677

 

 

Consolidated Statements of Cash Flows

For the years ended December 31, 2016 and 2015

 

 

 

2016

 

 

2015

 

Cash flows from operating activities

 

 

 

 

 

 

 

 

Net loss for the year

 

$

(3,303,538

)

 

$

(9,311,913

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Accrued income on marketable securities

 

 

14,244

 

 

 

4,199

 

Depreciation and amortization

 

 

286,162

 

 

 

299,995

 

Reserve for obsolete inventory

 

 

32,333

 

 

 

-

 

Impairment of non-current assets

 

 

-

 

 

 

466,476

 

Allowance for doubtful accounts

 

 

(1,153,413

)

 

 

2,163,609

 

Gain from other non-operating activities

 

 

-

 

 

 

(6,052

)

Fair value of restricted common stock issued for services

 

 

30,153

 

 

 

344,656

 

Share based compensation to employees - options

 

 

27,977

 

 

 

23,636

 

Share based compensation to non-employees - options

 

 

23,676

 

 

 

28,720

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

(Increase)/decrease in trade receivables

 

 

(138,272

)

 

 

513,583

 

Increase in trade receivables - related party

 

 

(380

)

 

 

-

 

Decrease in notes receivables - related party

 

 

-

 

 

 

176,157

 

(Increase)/decrease in deposits and other receivables

 

 

71,795

 

 

 

(54,142

)

Increase in inventories

 

 

(187,200

)

 

 

(226,538

)

(Increase)/decrease in prepaid expenses

 

 

17,689

 

 

 

(76,774

)

Decrease in prepaid expenses - related party

 

 

76,927

 

 

 

-

 

Increase/(decrease) in trade and other payables

 

 

(205,368

)

 

 

827,601

 

Increase in trade and other payables - related party

 

 

234,067

 

 

 

-

 

Decrease in deferred revenue - related party

 

 

-

 

 

 

(305,556

)

Net cash used in operating activities

 

 

(4,173,148

)

 

 

(5,132,343

)

 

 

 

 

 

 

 

 

 

Cash flows from investing activities

 

 

 

 

 

 

 

 

Purchases of property, plant and equipment

 

 

(123,301

)

 

 

(112,951

)

Purchases of marketable securities

 

 

(35,944

)

 

 

(60,940

)

Investment in Hainan Savy Akers Biosciences, Ltd. joint venture

 

 

-

 

 

 

(64,091

)

Proceeds from other non-operating activities

 

 

-

 

 

 

6,052

 

Proceeds from sale of marketable securities

 

 

4,003,034

 

 

 

5,310,491

 

Net cash provided by investing activities

 

 

3,843,789

 

 

 

5,078,561

 

 

 

 

 

 

 

 

 

 

Net decrease in cash

 

 

(329,359

)

 

 

(53,782

)

Cash at beginning of year

 

 

402,059

 

 

 

455,841

 

Cash at end of year

 

$

72,700

 

 

$

402,059

 

 

 

 

 

 

 

 

 

 

Supplemental Schedule of Non-Cash Financing and Investing Activities

 

 

 

 

 

 

 

 

Issuance of restricted common stock grant to an officer

 

$

54,725

 

 

$

-

 

Net unrealized gains on marketable securities

 

$

6,231

 

 

$

13,893

 

Settlement of note receivable in the form of inventory

 

$

750,000

 

 

$

-

 

Settlement of note receivable in the form of prepaid expense

 

$

549,609

 

 

$

-

 

Issuance of restricted common share grants to directors and officers accrued in 2014

 

$

-

 

 

$

697,300

 

 

 

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.

 

The information communicated in this announcement is inside information for the purposes of Article 7 of Regulation 596/2014.

 

 

This information is provided by RNS
The company news service from the London Stock Exchange
 
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