TIDMLSIC

RNS Number : 5928Z

Lifeline Scientific, Inc

21 September 2015

Lifeline Scientific, Inc.

("Lifeline" or the "Company")

Half Yearly Report

Lifeline Scientific (AIM: LSIC), the transplantation technology company, announces its half yearly results for the six months ended 30 June 2015. The results build upon growth achieved in 2014 and show expected improvement at the operating level. The Company continues to drive planned new product and territory expansion initiatives and remains confident of delivering further growth for the full year in line with market expectations.

Financial highlights

   --      Transplantation products and services revenues up by 1.3% to US$15.0m (H1 2014: US$14.8m) 

-- North America revenues up 3.8% to US$12.4m (H1 2014: US$12.0m)

-- Revenue outside of North America of US$2.6m (H1 2014: US$2.8m) representing 17.2% of total revenue (H1 2014: 19.2%)

-- LifePort(R) proprietary consumables steady at US$8.5m (H1 2014: US$8.5m)

   --      Gross profit decreased 4.5% to US$8.9m (H1 2014: US$9.4m) 
   --      Income from operations of US$0.1m (2014:US$0.0m) 
   --      Net income of US$0.1m (H1 2014: US$0.1m loss) 
   --      Net cash generated from operations of US$1.0m (H1 2014: US$0.3m) 
   --      Cash of US$3.1m as of 30 June 2015 (as of 31 December 2014: US$3.3m) 

Operational highlights

-- Installed base of LifePort Kidney Transporters grew to 204 leading transplant programmes in 28 countries worldwide (H1 2014: 185 in 27 countries)

   --      Key account wins in North America and further adoption in Europe and Middle East 
   --      China FDA (CFDA) approvals awarded for KPS-1 and SPS-1 

-- Preliminary results from pivotal multi-centre clinical study in Brazil show statistically significant benefits with LifePort vs. static cold storage for donor kidneys

   --      US FDA review underway for LifePort Liver Transporter 

-- Early sales recorded of LifePort Liver Transporter and complementary products under observational research protocols

   --      Several new patents issued supporting LifePort and related products 

-- Additional medical journal articles published further establishing clinical benefits of hypothermic machine preservation for donor kidneys

Post-period end highlights

-- CFDA approvals awarded for LifePort Kidney Transporter and its full suite of proprietary single-use consumables allows for national commercial launch

David Kravitz, Chief Executive Officer of Lifeline, said:

"The long awaited regulatory approvals from China's FDA for our full suite of LifePort Kidney Transporter products and our market leading organ preservation and flush solutions, KPS-1 and SPS-1, was particularly significant and paves the way for the national launch of our products in China later this year. These account wins and the CFDA approvals, combined with other regulatory and major new account wins in important growth territories, is further evidence that our plans for geographical expansion are on track. With LifePort Liver Transporter progressing through regulatory review and a solid slate of pipeline opportunities, prospects for the Company remain strong and I believe that Lifeline is at a key inflection point for growth. We are encouraged by the positive outlook for the second half of 2015 and into 2016 and it is in this context that we are exploring a full range of strategic and financial alternatives to best deliver maximum shareholder value."

For further information please contact:

 
 Lifeline Scientific, Inc.                                           www.lifeline-scientific.com 
 David Kravitz, CEO                                                         Tel: +1 847 294 0300 
 Lisa Kieres, CFO                                                           Tel: +1 847 294 0300 
 
 Panmure Gordon (UK) Limited                                                 +44 (0)20 7886 2500 
 Freddy Crossley / Duncan Monteith (Corporate 
  Finance) 
 Maisie Atkinson (Corporate Broking) 
 
 Walbrook PR                                      +44 (0)20 7933 8780 or lifeline@walbrookpr.com 
 Paul McManus                                                                +44 (0)7980 541 893 
 Mike Wort                                                                   +44 (0)7900 608 002 
 
 

About Lifeline Scientific Inc.

Lifeline Scientific, Inc. is a Chicago-based global medical technology company with regional offices in Brussels and Sao Paulo. The Company's focus is the development of innovative products that improve transplant outcomes and lower the overall costs of transplantation. Its lead product, LifePort Kidney Transporter, is the global market-leading medical device for hypothermic machine preservation of donor kidneys. LifePorts and novel solutions designed for preservation of other organs are in development, with LifePort Liver Transporter next in line for commercial launch. For more information please visit www.lifeline-scientific.com

About LifePort Kidney Transporter

Created with the challenges of organ recovery and transport in mind, LifePort Kidney Transporter is a proprietary medical device designed to help improve kidney preservation, evaluation and transport prior to transplantation. It has been widely studied in clinical trials throughout the world and is the standard of care for machine preservation of kidneys. Employed by surgeons in over 200 leading transplant programmes in 29 countries, LifePorts have successfully preserved more than 70,000 kidneys indicated for clinical transplant. For more information please visit www.organ-recovery.com

About LifePort Liver Transporter

LifePort Liver Transporter is modelled upon the clinically proven technology platform of LifePort Kidney Transporter and the Company's early HMP prototype successfully used in clinical transplant studies by surgeons at New York-Presbyterian Hospital/Columbia University Medical Center. LifePort Liver Transporter and the Company's proprietary machine preservation solution, Vasosol(R), are in the process of US and international regulatory registrations. The system is designed to help improve outcomes in liver transplantation by enabling the clinical use of hypothermic machine perfusion, and has been developed in consultation with clinical and research teams specialising in liver transplantation at Columbia University Medical Center and the University of Chicago. The system employs a rugged, streamlined ergonomic design for ease of use and transportability from donor bedside to recipient operating room. For more information please visit: http://www.organ-recovery.com/pipeline.php

Chairman's Statement

Revenues from transplantation products and services were US$15.0m (H1 2014: US$14.8m), representing overall growth of 1.3% compared to the same period last year.

We saw steady growth in our core North American market with revenues up 3.8% to US$12.4m (H1 2014: US$12.0m). Revenues outside North America were slightly down to US$2.6m (H1 2014: US$2.8m), a fall of 9.1%. Revenues outside of North America represent 17.2% of the total revenue for the period (H1 2014: 19.2%).

Whilst overall sales outside of North America dipped slightly, we expect to make important H2 headway in Brazil and Asia, particularly following the receipt of formal CFDA regulatory approvals for the full suite of LifePort(R) Kidney Transporter products and preservation solutions. Ahead of these approvals China product sales of US$3.3m were realised during LifePort Kidney Transporter's three year pre-launch period, including US$0.2m for the six months ending 30 June 2015 (H1 2014: nil) where our products were being used under clinical research exemptions.

In Europe, adoption of the full suite of LifePort Kidney Transporter products continues to increase following our French National Tender award last year. Revenue in local currency for that region of EUR2.1m increased 13.3% for the period over last year (H1 2014: EUR1.8m), with proprietary LifePort Kidney consumables increasing by 24%. Consolidated, in US$, the resulting European sales decreased slightly on the previous year at US$2.3m (H1 2014: US$2.5m), due to a strengthening of the dollar year-on-year. Sales from South America accounted for US$0.1m (H1 2014: US$0.3m), reflecting previously announced systemic complexities around importation of medical products in Brazil. We are optimistic about growth in these markets over the medium and long term as concentrated efforts are in place to accelerate LifePort adoption and preservation solution sales.

LifePort proprietary consumables are in line with last year at US$8.5m (H1 2014: US$8.5m) and sales of our solutions products increased by 11.4% to US$5.6m (H1 2014: US$5.0m). LifePort Kidney Transporter unit sales were down to US$0.5m year-on-year (H1 2014: US$0.8m), as the comparable period benefited from a relatively high number of LifePort orders that arose following our win of the French National tender. We also saw the first pre-regulatory approval sales of our new LifePort Liver Transporter, with US$0.1m in revenue for product use under observational research protocols.

While gross profit decreased 4.5% to US$8.9m (H1 2014: US$9.4m), due primarily to a relatively high volume of lower margin solution sales, EBITDA increased to US$0.7m (H1 2014: US$0.5m) reflecting sound operating cost controls and reduced research and development expenditure as LifePort Liver Transporter moves into commercialisation.

Net cash generated from operations for the period increased significantly, reaching US$1.0m (H1 2014: US$0.3m). The cash position of the Company remains strong, with cash balances as of 30 June 2015 of US$3.1m (31 December 2014: US$3.3m) and a revolver balance of US$2.2m (31 December 2014: US$2.2m). Research and development costs were significantly reduced to US$0.5m (H1 2014: US$1.4m).

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September 21, 2015 02:01 ET (06:01 GMT)

The regulatory approvals from the CFDA were significant as they considerably increase the size and potential for growth of our global market opportunity. Over time, China alone could become a larger transplant market than both the US and Europe combined. This and other key account wins in Europe and the Middle East demonstrate significant progress in our geographic expansion efforts, and underpin the opportunity for further growth in the second half of 2015 and beyond. Furthermore, as regulatory reviews advance for our LifePort Liver Transporter, we are preparing for its commercial introduction, and Lifeline's future appears very promising indeed.

John Garcia

Chairman

21 September 2015

Chief Executive Officer's review

The Company continued to drive its planned new product and territory expansion initiatives in this period and expects to see further growth in 2015. This drive has been supported by additional revenue contribution from key high value contract wins exceeding US$1.2m, which further illustrates our capabilities for ensuring LifePort(R) benefits are well understood within the worldwide transplant community. This progress coupled with the long awaited CFDA regulatory approvals for our LifePort Kidney Transporter and full product line, gives us confidence that the Company is on track to meet market expectations for the full year.

Territories Progress

North America

North America continues to be the largest contributor to the Company's revenue base, with first half 2015 revenues accounting for 83% of worldwide sales, an increase of 3.8% to US$12.4m (H1 2014: US$12.0m). In July 2015, we announced a major new account win as the Alabama regional transplant programme adopted our full suite of LifePort Kidney Transporter and solutions products. This key account is anticipated to bring annualised revenues of over US$0.8m, with an initial contribution reflected in final year results. We are grateful to see these new accounts coming on board as we broaden our geographical reach in the US. LifePort Kidney Transporter is now the standard of machine preservation of donor kidneys in nearly all major US Organ Procurement Organisations and in all provinces in Canada.

Europe

France is one of Europe's three largest national markets for kidney transplant procedures and remains a key territory for the Company. Nationwide, there is now an installed base of over 100 LifePort Kidney Transporters. We received new orders to supply LifePorts and related consumables to new transplant programme accounts in Paris, Nancy, Metz, and Montpellier, taking the number of LifePort exclusive sites to 33 of France's 34 renal transplant programmes.

In addition to our success in France, the Swiss national transplant system adopted LifePort as their standard of care for machine preservation of renal allografts and placed initial orders for Switzerland's six transplant centres, while new LifePort accounts were also opened respectively in Barcelona, Spain; Innsbruck, Austria; and Riyadh, Saudi Arabia.

China

On 3 September 2015 we announced the long awaited CFDA regulatory approval for LifePort Kidney Transporter and its full complement of single-use consumables for commercial sale in China. This important milestone for the Company allows our LifePort products to be formally launched nationwide in China; a key target growth market for the Company. This positive development followed our February announcement of regulatory approvals in China for our market leading clinical organ preservation and flush solutions, SPS-1(R) and KPS-1(R). During LifePort's three year regulatory review process, 21 of China's major renal transplant centres adopted LifePort under observational research protocols during which time revenues of over US$3.3m were realised by the Company and a reported 1,340 LifePort preserved kidneys were successfully transplanted.

As China undergoes a transformational positive change in the structure and management of its national transplant and donor recovery programmes, Chinese health authorities have recognised the need for state-of-the-art technologies to help bridge the gap of the nation's very large unmet demand for transplants. Recently China's health ministry reported an official national transplant waiting list of 30,000 registered patients, with an overall estimate of patients in need at more than 300,000. Lifeline has made strategically significant investments of time and capital in developing the China market including key commercial distribution and clinical relationships that serve China's reported 169 renal transplant hospitals. With the Company's full suite of core products having now received regulatory approval for commercial sales to hospitals, and our nationwide distribution partners on board, we are looking forward to supporting the commercial roll-out of our products, and achieving important growth in this region during the next year and beyond.

Brazil

New clinical evidence from a pivotal 10-centre, independent investigator driven LifePort trial has produced very encouraging results. This is particularly significant as Brazil is the world's second largest national renal transplant market with over 4,500 deceased donor kidneys recovered annually for transplants across 127 renal transplant centers. We are experiencing continued enthusiasm for LifePort adoption among leading clinicians and organ procurement centers across the country, and during the period, our Brazilian distributors welcomed Real Hospital Português de Beneficência em Pernambuco as a new LifePort and solutions customer.

We continue to work closely with opinion leading Brazilian transplant surgeons, organ procurement organisations, and health ministry officials to create practical solutions to logistical and process challenges associated with the importation of our products from the US. This effort includes ongoing negotiations with national level transplant administration leadership attempting to organise an approximate US$2.4m national order for LifePort. Advancing this process is the Company's top priority in Brazil for 2015.

Further supporting long-term optimism, our Brazil distributor reports that combined orders for LifePort and our branded preservation solutions valued at near US$2.0m, are in process from several leading transplant programmes. While past precedent suggests that no assurances can be given on timing or completion of these orders, this reported progress is very encouraging. Lifeline has recognised over US$4.0m in high margin revenues generated through our Brazil distributor since Brazil's regulatory agency, ANVISA, began awarding commercialisation approvals for our products late in 2010.

Most notably, our prospects for broad LifePort adoption in South America recently received important support from the reporting of preliminary results of Brazil's pivotal 10-centre LifePort clinical trial. This prospective, randomised study compared outcomes of transplant patients with kidneys preserved on LifePort vs. the present standard of kidney preservation in Brazil: static storage in a cool box filled with ice. Led by surgeons and scientists at the highly regarded Hospital do Rim, the world's largest volume renal transplant centre, the study investigators report their initial data showing a statistically significant reduction in delayed graft function (DGF), faster recovery of kidney function post-transplant, and reduced incidence of acute graft rejection. This data will be formally presented at the annual Brazilian Transplantation Association congress in late October and we expect to provide more detail following publication of this compelling data.

New Clinical Evidence

We continue to be encouraged by the publication of additional scientific research papers and clinical data supporting broad clinical adoption of LifePort Kidney Transporter. As well, the peer reviewed and published clinical trial results from studies using early prototypes of our LifePort Liver Transporter have provided solid support for our regulatory filings now in process. These data underpin the principal mission of Lifeline Scientific: to help patients in need of a life-saving transplant by enabling clinicians to improve transplant outcomes through improved technology for organ preservation, evaluation and transport. During the period under review there have been two notable publications one of which provides a promising case study for informing protocols used for kidney transplants in key institutions within the UK and abroad.

The first study, led by Drs. Andrew Ready, Alison Guy, and colleagues in the Department of Renal Surgery at the New Queen Elizabeth Hospital Birmingham, one of the UK's largest centres for renal transplantation, was published in the June edition of Experimental and Clinical Transplantation. The study titled: "Hypothermic Machine Perfusion Permits Extended Cold Ischemia Times With Improved Early Graft Function", has led the New Queen Elizabeth Hospital to implement a standard of practice whereby all deceased donor kidneys intended for transplant are placed on LifePort Kidney Transporter. These clinical outcomes show a direct correlation between the reporting of good quality data and the commercial adoption of new technologies such as LifePort Kidney Transporter. In addition, and as a direct response to the publication of these findings, Belfast City Hospital, Northern Ireland, where conditions often require longer preservations times for donor kidneys prior to transplant, has also adopted LifePort.

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September 21, 2015 02:01 ET (06:01 GMT)

A second study, supporting the new Lifeline Liver Transporter, by Dr. James Guarrera and colleagues at New York-Presbyterian Hospital/Columbia University Medical Center, was published in the American Journal of Transplantation titled: "Hypothermic Machine Preservation (HMP) Facilitates Successful Transplantation of "Orphan" Extended Criteria Donor Livers." The HMP liver transplant recipients experienced higher one-year survival rates, shorter hospital stays and fewer long-term complications. Even more impressive, the HMP livers used in the Study were considered "orphan livers," defined as organs rejected by every transplant centre in the United Network for Organ Sharing region where they were originally offered. The authors concluded that HMP (using an early prototype LifePort Liver Transporter system), has meaningful clinical utility with the potential to increase the number of donor livers suitable for transplantation, closing the wide gap between organ supply and demand.

New Technology Developments and Product Innovations

While awaiting regulatory approvals for LifePort Liver Transporter, we continue to gather data from observational human factors studies designed to help us prepare for end-user training and providing logistical advice to client liver transplant centres during our post-clearance product launch. These data are confirming LifePort Liver Transporter's intended design for ease of use and robustness under the rigours of real-life organ recovery practice. In preparation for the launch of LifePort Liver Transporter we are also building product inventory, customer training and service infrastructure to support initial commercialisation.

Developed under the Lifeline umbrella, Tissue Testing Technologies, LLC ("T3"), a 49% owned strategic affiliate, was awarded three new grants totaling US$1.56m by the US National Institutes of Health (NIH) to create improved preservation and evaluation systems for various cells, tissues, and organs. The awards focus on specific aspects of cryopreservation aimed at improving tissue viability and ensuring process standardisation and consistency of supply. The research protocol is specifically designed to advance Lifeline's proprietary ice-free vitrification technology (-70c preservation) of engineered human tissue equivalents used for in vitro toxicology testing. The research will focus on optimising the Company's technology developed in an earlier NIH Phase I grant, and further characterise preserved Epiderm constructs with an aim to demonstrate that the overall integrity and function of the construct has not changed. Optimisation will include making the preservation process more efficient, along with storage studies to determine optimal tissue storage times. In addition, the protocol will be applied to other relevant tissue equivalents, such as Epiderm-FT, EpiAirway and EpiOcular, currently being commercially used in toxicity studies. A growing demand for scientific research, diagnostic and clinical applications of naturally occurring and engineered cells, tissues and organs has created a large and growing market. Recent industry analysis projects the market for bio-preservation products and services to grow beyond US$800m within the next five years.

Through our research and product development collaborations, meaningful advancements were also made in the development of LifePort based technology for real time, ex vivo evaluation of key biomarkers of organ viability, and patient point-of-care therapeutic drug monitoring (TDM) assays for commonly used post-transplant immunosuppressant drugs. Initial studies evaluating aspects of the multi-thermic LifePort Workstation and LifePort embedded technologies for delivering supplemental oxygen to perfusate during ex vivo organ preservation are also underway.

Summary & Outlook

The first half of 2015 further demonstrated LifePort Kidney Transporter's growing recognition as the clinical standard worldwide for machine preservation of donor kidneys, as the installed LifePort base expanded globally into 11 major new transplant programmes. These new accounts are expected to deliver continued growth in the second half and beyond.

A key milestone achievement, and a major driver of potential future growth, is the long awaited approval from the CFDA for our full LifePort Kidney Transporter offering allowing the China national launch of our products to begin towards the end of this year. We are confident that this remains a key growth territory with the potential to become a larger market for transplantation than the US and EU combined over the next five to seven years.

Brazil's recent approval of our newest generation of LifePort Kidney Transporter with available features such as GPS/GPRS capability was an important achievement and the initial reports of key scientific evidence supporting LifePort adoption and strong clinician support and pipeline of demand from Brazil is a reminder of the additional significance this market hold for future growth. In addition, notable progress was made advancing the US regulatory review for our new LifePort Liver Transporter and preparations for commercial product introduction.

In keeping with our Company's mission, we are committed to staying closely in touch with our customer communities of clinicians, patients and payors, and will continue to develop product innovations driven by their needs.

The pipeline of growth opportunities for our Company remains strong as is the outlook for the second half of 2015 and into 2016. As a Board we believe that Lifeline is at a key inflection point for growth. Now more than ever we are encouraged by the Company's positive outlook and it is in this context that we are exploring a full range of strategic and financial alternatives to best deliver maximum shareholder value.

David Kravitz

Chief Executive Officer

21 September 2015

LIFELINE SCIENTIFIC, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

30 June 2015 and 2014

(In US Dollars unless otherwise noted)

UNAUDITED

 
                                                            2015           2014 
                                                             US$            US$ 
 Current Assets 
 Cash and cash equivalents                             3,052,021      2,535,142 
 Receivables 
      Customers (net of allowance for doubtful 
       accounts of $308,000 and $0 as of 30 June 
       2015 and 2014, respectively)                    6,508,385      6,899,704 
 Grant                                                    12,000         79,909 
 Deferred tax assets                                      97,472         97,472 
 Income taxes receivable                                  56,030              - 
 Inventories                                           6,830,276      5,977,631 
 Prepaid expenses, deposits, and other                 1,254,061      1,003,210 
                                                   -------------  ------------- 
 Total Current Assets                                 17,810,245     16,593,068 
 Non-current Assets 
 Property and equipment (net of accumulated 
  depreciation 
  and amortisation)                                    3,284,459      3,556,914 
 Intangibles (net of accumulated amortisation)         4,899,709      4,018,111 
 Deferred tax assets                                   3,242,213      1,942,213 
 Goodwill                                                 64,710         64,710 
 Other                                                    67,671         91,152 
                                                   -------------  ------------- 
 Total Non-current Assets                             11,558,762      9,673,100 
                                                   -------------  ------------- 
 Total Assets                                         29,369,007     26,266,168 
                                                   =============  ============= 
 Current Liabilities 
 Revolving line of credit                              2,171,147      1,000,000 
 Accounts payable                                      1,173,453      1,701,022 
 Income taxes payable                                          -         10,428 
 Long-term debt due within one year                            -        470,118 
 Capital lease obligations due within one 
  year                                                    18,630         25,010 
 Accrued expenses 
      Interest due within one year                         6,186        185,247 
      Salaries and other compensation                    706,056        720,789 
      Other                                            1,565,080      1,100,228 
 Deferred rent                                            83,162         11,778 
 Deferred revenue                                        106,728         98,700 
                                                   -------------  ------------- 
 Total Current Liabilities                             5,830,442      5,323,320 
 Non-current Liabilities 
 Long-term debt (net of portion included 
  in current liabilities)                                      -        582,179 
 Deferred rent (net of portion included 
  in current liabilities)                                245,361        372,398 
 Accrued interest (net of portion included 
  in current liabilities)                                      -        147,560 
 Capital leases (net of portion included 
  in current liabilities)                                 39,946         75,969 
                                                   -------------  ------------- 
 Total Non-current Liabilities                           285,307      1,178,106 
                                                   -------------  ------------- 
 Total Liabilities                                     6,115,749      6,501,426 
                                                   -------------  ------------- 
 Stockholders' Equity 
 Common stock, $0.01 par value; authorized 
  - 30,000,000 shares; issued and outstanding 
  - 19,516,434 and 19,453,613 shares as 

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September 21, 2015 02:01 ET (06:01 GMT)

  of 30 June 2015 and 2014, respectively                 195,164        194,536 
 Additional paid-in capital                           93,674,973     94,480,758 
 Other accumulated comprehensive loss                  (750,533)      (272,219) 
 Accumulated deficit                                (69,866,346)   (73,472,398) 
                                                   -------------  ------------- 
 Total Lifeline Scientific, Inc. Stockholders' 
  Equity                                              23,253,258     20,930,677 
                                                   =============  ============= 
 Non-controlling interest                                      -    (1,165,935) 
 Total Stockholders' Equity                           23,253,258     19,764,742 
                                                   -------------  ------------- 
 Total Liabilities and Stockholders' Equity           29,369,007     26,266,168 
                                                   =============  ============= 
 

LIFELINE SCIENTIFIC, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

Six months ended 30 June 2015 and 2014

(In US Dollars unless otherwise noted)

UNAUDITED

 
                                                         2015         2014 
                                                          US$          US$ 
 Net revenue 
      Product sales and service fee revenue        15,019,466   14,820,733 
      Grant revenue                                         -      297,242 
                                                  -----------  ----------- 
 Total net revenue                                 15,019,466   15,117,975 
 Cost of revenue                                    6,070,896    5,752,202 
                                                  -----------  ----------- 
 Gross profit                                       8,948,570    9,365,773 
                                                  -----------  ----------- 
 Gross profit percentage                                59.6%        62.0% 
 Operating expenses 
      Research and development                        512,662    1,350,193 
      Selling, general, and administrative          8,261,543    8,024,491 
      Loss (gain) from disposal of property 
       and equipment                                    3,979        (697) 
      Loss from abandonment of intangibles             35,539            - 
                                                  -----------  ----------- 
 Total operating expenses                           8,813,723    9,373,987 
                                                  -----------  ----------- 
 Income (loss) from operations                        134,847      (8,214) 
                                                  -----------  ----------- 
 Other expense (income) 
      Interest expense                                 37,087       52,482 
      Interest income                                   (348)      (1,294) 
                                                  -----------  ----------- 
 Total other expense                                   36,739       51,188 
                                                  -----------  ----------- 
 Income (loss) before income taxes                     98,108     (59,402) 
 Income tax expense (benefit)                           3,197      (3,137) 
                                                  -----------  ----------- 
 Net income (loss)                                     94,911     (56,265) 
 Less: net loss attributable to non-controlling 
  interest                                                  -       86,499 
                                                  -----------  ----------- 
 Net income (loss) attributable to Lifeline 
  Scientific, Inc.                                     94,911       30,234 
                                                  ===========  =========== 
 Basic income (loss) per share                           0.00         0.00 
 Diluted income (loss) per share                         0.00         0.00 
 Basic weighted average shares outstanding 
  (in shares)                                      19,498,865   19,445,881 
 Diluted weighted average shares outstanding 
  (in shares)                                      20,077,680   20,163,366 
 

LIFELINE SCIENTIFIC, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME

Six months ended 30 June 2015 and 2014

(In US Dollars unless otherwise noted)

UNAUDITED

 
                                                            2015       2014 
                                                             US$        US$ 
 
 Net income (loss)                                        94,911   (56,265) 
 
 Foreign currency translation                          (228,238)   (18,509) 
                                                      ----------  --------- 
 
 Comprehensive loss                                    (133,327)   (74,774) 
 
 Comprehensive loss attributable to non-controlling 
  interest                                                     -   (86,499) 
                                                      ----------  --------- 
 
 Comprehensive (loss) income attributable to 
  Lifeline Scientific, Inc.                            (133,327)     11,725 
                                                      ==========  ========= 
 

LIFELINE SCIENTIFIC, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

Six months ended 30 June 2015 and 2014

(In US Dollars unless otherwise noted)

UNAUDITED

 
                                               Lifeline Scientific, Inc. Stockholders 
                                                                                Other 
                                                         Additional       Accumulated 
                                                            Paid-in     Comprehensive    Accumulated   Non-controlling 
                        Total       Shares   Par Value      Capital              Loss        Deficit          Interest 
                  -----------  -----------  ----------  -----------  ----------------  -------------  ---------------- 
 
 Balance, 1 
  January 
  2014             19,685,198   19,446,720     194,467   94,326,509         (253,710)   (73,502,632)       (1,079,436) 
 Issuance of 
  common 
  stock in 
  conjunction 
  with cashless 
  option 
  exercise                  -        6,893          69         (69)                 -              -                 - 
 Stock-based 
  compensation        154,318            -           -      154,318                 -              -                 - 
 Foreign 
  currency 
  translation        (18,509)            -           -            -          (18,509)              -                 - 
 Net loss            (56,265)            -           -            -                 -         30,234          (86,499) 
                  -----------  -----------  ----------  -----------  ----------------  -------------  ---------------- 
 
 Balance, 30 
  June 
  2014             19,764,742   19,453,613     194,536   94,480,758         (272,219)   (73,472,398)       (1,165,935) 
                  ===========  ===========  ==========  ===========  ================  =============  ================ 
 
 Balance, 
  1January 
  2015             23,261,074   19,496,434     194,964   93,549,662         (522,295)   (69,961,257)                 - 
 Issuance of 
  common 
  stock in 
  conjunction 
  with option 
  exercise             11,903       20,000         200       11,703                 -              -                 - 
 Stock-based 
  compensation        113,608            -           -      113,608                 -              -                 - 
 Foreign 
  currency 
  translation       (228,238)            -           -            -         (228,238)              -                 - 
 Net income            94,911            -           -            -                 -         94,911                 - 
                  -----------  -----------  ----------  -----------  ----------------  -------------  ---------------- 
 Balance, 30 
  June 
  2015             23,253,258   19,516,434     195,164   93,674,973         (750,533)   (69,866,346)                 - 
                  ===========  ===========  ==========  ===========  ================  =============  ================ 
 
 

LIFELINE SCIENTIFIC, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

Six months ended 30 June 2015 and 2014

(In US Dollars unless otherwise noted)

UNAUDITED

 
                                                        2015          2014 
                                                         US$           US$ 
 Cash flows from operating activities 
 Net income (loss )                                   94,911      (56,265) 
 Adjustments to reconcile net income (loss) 
  to net cash provided by (used in) operating 
  activities: 
 Depreciation and amortisation of property 
  and equipment                                      471,590       407,777 
 Amortisation of intangibles                         112,219        89,716 
 Stock-based compensation                            113,608       154,318 
 Loss (gain) on disposal of property and 
  equipment                                            3,979         (697) 
 Loss on abandonment of intangibles                   35,539             - 
 (Increase) decrease in: 
      Receivables                                  2,487,086       957,015 
      Inventories                                  (922,366)     (642,536) 
      Prepaid expenses and deposits                (440,334)       292,539 
      Other assets                                   267,793       269,317 
 Increase (decrease) in: 
      Accounts payable                           (1,186,997)     (399,550) 
      Accrued expenses                             (218,918)     (735,457) 
      Accrued interest                                     -       (9,671) 
      Deferred revenue                                61,350        20,806 
      Deferred rent                                   75,504      (31,021) 

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      Other liabilities                                    -         (238) 
                                                ------------  ------------ 
 Total adjustments                                   860,053       372,318 
                                                ------------  ------------ 
 Net cash provided by operating activities           954,964       316,053 
                                                ------------  ------------ 
 Cash flows from investing activities 
 Payments related to intangible assets 
  and legal fees 
  associated with patent filings                   (610,420)     (492,677) 
 Capital expenditures                              (505,524)   (1,158,804) 
                                                ------------  ------------ 
 Net cash used in investing activities           (1,115,944)   (1,651,481) 
                                                ------------  ------------ 
 Cash flows from financing activities 
 Cash received from option exercises                  11,903             - 
 (Repayments) borrowings under capital 
  lease obligations, net                            (14,520)        34,298 
 Borrowings of long-term debt                              -     1,000,000 
 Principal payments on long-term debt                (2,106)     (174,178) 
                                                ------------  ------------ 
 Net cash (used in) provided by financing 
  activities                                         (4,723)       860,120 
                                                ------------  ------------ 
 Effect of foreign currency exchange rate 
  changes on cash                                  (106,053)      (11,690) 
 Net decrease in cash and cash equivalents         (271,756)     (486,998) 
                                                ------------  ------------ 
 Cash and cash equivalents, beginning of 
  period                                           3,323,777     3,022,140 
                                                ------------  ------------ 
 Cash and cash equivalents, end of period          3,052,021     2,535,142 
                                                ============  ============ 
 

NOTE 1 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

General: The accompanying condensed consolidated financial statements of Lifeline Scientific, Inc. (the "Company") are unaudited and do not include all of the footnotes required by accounting principles generally accepted in the United States of America ("US GAAP"). In the opinion of management of the Company, these condensed consolidated financial statements contain all adjustments necessary for a fair presentation of the results for the interim periods presented. These statements should be read in conjunction with the Company's annual report as of and for the year ended 31 December 2014.

Principles of Consolidation: The Company was incorporated in the state of Delaware as Organ Recovery Systems, Inc. on 1 October 1998. On 20 December 2007, the Company changed its name to Lifeline Scientific, Inc. The Company is consolidated with the following subsidiaries:

ORS Europe, NV (1)

Cell and Tissue Systems, Inc. (2)

Organ Recovery Systems, Inc. (1)

ORS Representacoes do Brasil LTDA (1)

(1) A wholly-owned subsidiary

(2) 49.00% owned prior to 19 December 2014; a wholly-owned subsidiary afterwards

Intercompany balances and transactions have been eliminated in consolidation.

The Consolidation Topic of US GAAP requires consolidation by the primary beneficiary where the variable interest entity does not have sufficient equity at risk to finance its activities without additional subordinated financial support from other parties. The application of this guidance resulted in the consolidation of Cell and Tissue Systems, Inc. ("CTS"), which was created during the year ended 31 December 2005 and was deemed to be a variable interest entity. CTS was primarily formed to meet regulatory requirements in order to enhance its ability and capacity to apply for funding from available government sources. The Company contributed $490 for the 49% ownership needed to form the variable interest entity. CTS had an accumulated deficit as of 30 June 2014.

In accordance with the requirements of the accounting standard under US GAAP that establishes accounting and reporting standards for non-controlling interests in a subsidiary in consolidated financial statements, the Company classified the non-controlling interest of CTS within the equity section of the consolidated balance sheets and separately reports the amounts attributable to controlling and non-controlling interests in the consolidated statements of operations for the six months ended 30 June 2014.

On 19 December 2014, the Company acquired the remaining outstanding 51.00% stock of CTS for $510. No gain or loss was recorded in conjunction with this transaction as the Company has already been consolidating CTS. The non-controlling interest was derecognised in connection with the acquisition of the equity interest not already owned. The difference between the non-controlling interest and the consideration paid is reflected in the equity of the Company.

Also on 19 December 2014, the Company jointly formed Tissue Testing Technologies LLC ("T3") with another party. T3 was formed to meet regulatory requirements in order to obtain research grants from various government sources. Under the terms of the operating agreement, the Company owns 49% of T3 and the other party owns 51%. .

Cash and Cash Equivalents: The Company considers all money market accounts and short-term investments with an original maturity of three months or less and US Treasury money markets to be cash equivalents. The majority of cash and cash equivalents as of 30 June 2015 and 30 June 2014 were held through a single financial institution, and the balances held at times may exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk on cash and cash equivalents.

Receivables: Receivables are carried at original invoice or closing statement amount less estimates made for doubtful receivables. Management determines the allowance for doubtful accounts by reviewing and identifying troubled accounts on a monthly basis and by using historical experience applied to an aging of accounts. A receivable is considered to be past due if any portion of the receivable balance is outstanding for more than 90 days. The Company does not charge interest on past due receivables. Receivables are written off when deemed uncollectible. Recoveries of receivables previously written off are recorded when received.

Inventories: Inventories are valued at the lower of cost (first-in, first-out) or market.

Depreciation and Amortisation: The Company's policy is to depreciate or amortise the cost of property and equipment over the estimated useful lives of the assets using the straight-line method. The cost of leasehold improvements is amortised over the estimated useful lives, or the applicable lease term, if shorter.

 
                            Years 
 Computer equipment           3-5 
 Furniture and fixtures       5-7 
 Equipment under capital 
  lease                       5-7 
 Laboratory equipment         3-7 
 Leasehold improvements       5-8 
 Tooling and moulds          1-15 
 Vehicles                       5 
 

Long-Lived Assets: Long-lived assets to be held are reviewed for events or changes in circumstances that indicate that their carrying value may not be recoverable. The Company periodically reviews the carrying value of long-lived assets to determine whether or not an impairment to such value has occurred. Management believes that no impairment of long-lived assets exists as of 30 June 2015 and 2014.

Intangibles: The cost of intangible assets is being amortised over the remaining lives of the assets acquired as follows:

 
                        Years 
 Certification marks     20 
 Patents                 17 
 Licensing agreement     10 
 

Professional and regulatory fees associated with obtaining the licenses that enable the Company to sell its products (i.e. certification marks) are capitalised and amortised over the shorter of the useful life of the related licenses or 20 years. Legal fees associated with filings for patents that are pending are capitalised if management believes that it is probable that such patent applications will be successful. Patent costs are not amortised until the patent is obtained. During the year ended 31 December 2010, the Company signed an agreement that allows for the licensing of technology to support the Company's product development efforts. The agreement is being amortised over the remaining estimated life of the licensed technology, or 10 years.

Goodwill: Goodwill results from business acquisitions and represents the excess of the purchase price over the fair value of acquired tangible assets and liabilities and identifiable intangible assets. In accordance with accounting for goodwill under US GAAP, goodwill is not amortised, but instead tested for impairment on an annual basis. The Company has applied Financial Accounting Standards Board ("FASB") Accounting Standards Update ("ASU") No. 2011-08, "Testing Goodwill for Impairment", in connection with the performance of the annual goodwill impairment test. Under FASB ASU 2011-08, entities are provided with the option of first performing a qualitative assessment on none, some, or all of its reporting units to determine whether further quantitative impairment testing is necessary. An entity may also bypass the qualitative assessment for any reporting unit in any period and proceed directly to the quantitative impairment test.

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Goodwill must be tested on an annual basis or if an event occurs or circumstances change that would more likely than not reduce the fair value of the reporting unit below its carrying amount. During the year ended 31 December 2014, the Company was not required to record any impairments to the carrying value of goodwill or indefinite-lived intangible assets. During the six months ended 30 June 2015 and 2014, the Company identified no events or circumstances that would trigger an interim assessement of goodwill.

Deferred Rent: Minimum rent expense is recognised over the term of the lease. The Company recognises minimum rent starting when possession of the property is taken from the landlord. When a lease contains a predetermined fixed escalation of the minimum rent, rent expense is recognised on a straight-line basis. Any difference between the recognised rent expense and the amounts payable under the lease is reported as deferred rent in the consolidated balance sheets. The Company records include a tenant allowance on its facility lease in Itasca, Illinois, which is recorded as a component of deferred rent and amortised as a reduction to rent expense over the term of the lease. Future payments for common area maintenance, insurance, real estate taxes, and other occupancy costs to which the Company is obligated are excluded from minimum lease payments.

Fair Value of Financial Instruments: US GAAP defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants as of the measurement date. US GAAP describes three approaches to measuring the fair value of assets and liabilities: the market approach, the income approach, and the cost approach. Each approach includes multiple valuation techniques. US GAAP does not prescribe which valuation technique should be used when measuring fair value, but does establish a fair value hierarchy that prioritises the inputs used in applying the various techniques. Inputs broadly refer to the assumptions that market participants use to make pricing decisions, including assumptions about risk. Level 1 inputs are given the highest priority in the hierarchy while Level 3 inputs are given the lowest priority. Assets and liabilities carried at fair value are classified in one of the following three categories based on the nature of the inputs to the valuation technique used:

Level 1 - Observable inputs that reflect unadjusted quoted prices for identical assets or liabilities in active markets as of the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis.

Level 2 - Observable market-based inputs or unobservable inputs that are corroborated by market data.

Level 3 - Unobservable inputs that are not corroborated by market data. These inputs reflect management's best estimate of fair value using its own assumptions about the assumptions a market participant would use in pricing the asset or liability.

The carrying values of cash and cash equivalents, accounts receivable, accounts payable, and revolving line of credit approximate their fair values because of the short-term nature of these instruments. The carrying values of long-term debt and capital leases approximate their fair values as the stated interest rates approximate current market interest rates of long-term debt and capital leases with similar terms.

Product Warranty: Estimated future costs applicable to products sold under warranty are charged to expense in the year of sale and the related liability is classified as current. The accrued warranty liability as of 30 June 2015 and 2014 was $168,047 and $179,310, respectively.

Revenue Recognition: Product sales revenue is recognised upon shipment of product to the client. Service fee revenue is recognised when services are performed. Deferred and unbilled revenue is recognised in the consolidated balance sheets.

Grant revenue is recognised when earned. Grant revenues are deemed earned to the extent of the total allowable expenditures incurred, which are specified in the grant contract. In some cases, a portion of the grant revenue is paid at the time the grant is initiated. These advances are deferred and recognised using the proportional performance model. Unbilled services are at times recorded for revenue recognised to date and relate to amounts that are currently unbillable to the client pursuant to contractual terms.

The Company sells extended warranties on its LifePort product for a specific period of months. This revenue is deferred and recognised over the term of the warranties on a straight-line basis.

Income Taxes: Income taxes are provided for the tax effects of transactions reported in the consolidated financial statements and consist of taxes currently due plus deferred taxes related primarily to differences between the basis of property and equipment, bad debts, intangibles, and accrued expenses for financial and income tax reporting. The deferred tax assets and liabilities represent the future tax return consequences of those differences, which will either be taxable or deductible when the assets and liabilities are recovered or settled. The carrying value of the Company's deferred tax assets is dependent upon its ability to generate sufficient taxable income in the future. The Company has established a valuation allowance against its net deferred tax assets to reflect the uncertainty of realising the deferred tax benefits, given historical losses and limited history of current earnings. A valuation allowance is required when it is more likely than not that all or a portion of a deferred tax asset will not be realised. During the year ended 31 December 2014, $1,300,000 of the valuation allowance was reversed to reflect the likelihood of future taxable income, which will most likely result in the utilisation of a portion of the Company's net operating losses. During the six months ended 30 June 2015, the Company determined no change to this estimate was required.

The Company is subject to US federal, state, and local taxes as well as foreign taxes in Belgium and Brazil. The Company's tax years extending back to the year ended 31 December 2010 remain open to examination for both federal and state jurisdictions; for foreign jurisdictions the Company's tax years extending back to December 31, 2011 remain open for examination. The Company's policy is to recognise interest and penalties related to uncertain tax positions as a component of income tax expense. During the six months ended 30 June 2015 and 2014, the Company did not recognise expense for interest and penalties. As of 30 June 2015 and 2014, the Company had $137,000 and $118,000, respectively, accrued for the payment of interest and penalties. The Company does not expect the total amount of unrecognised tax benefits to significantly change during the next 12 months.

The Company's consolidated financial statements provide for any related US tax liabilities on earnings of foreign subsidiaries that may be repatriated, aside from qualifying undistributed earnings of certain foreign subsidiaries that are intended to be indefinitely reinvested in operations outside of the US.

The Company accounts for unrecognised tax benefits in accordance with US GAAP, which prescribes a more likely than not threshold for consolidated financial statement presentation and measurement of a tax position taken or expected to be taken in a tax return. A tax position is recognised as a benefit only if it is "more likely than not" that the tax position would be sustained in a tax examination, with a tax examination being presumed to occur. The amount recognised is the largest amount of tax benefit that is greater than 50% likely of being realised on examination. For tax positions not meeting the "more likely than not" test, no tax benefit is recorded.

Stock Options: In accordance with US GAAP, the Company accounts for the cost of employee services received in exchange for an award of equity instruments utilising the grant date fair value of the award. Stock-based awards that do not require future service (i.e., vested awards) are expensed immediately. The expense associated with stock-based employee awards that require future service are amortised over the relevant service period.

Management Estimates: The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. The estimates included by the Company in these consolidated financial statements relate to warranty reserves, allowance for doubtful accounts, the useful lives of patents and the license agreement, the useful lives of depreciable property and equipment, and the valuation allowance for deferred tax assets.

Research and Development: Expenditures relating to the development of new products and procedures are expensed as incurred.

Foreign Currency Translation: The financial position and results of operations of the Company's foreign subsidiaries are measured using the subsidiary's local currency as the functional currency. Assets and liabilities of the foreign subsidiaries are translated to US dollars using exchange rates in effect as of the consolidated balance sheet dates. Income and expense items are translated at monthly average rates of exchange. The resultant translation gains or losses are included as part of the components of stockholders' equity designated as other comprehensive loss.

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Contingencies: During the six months ended 30 June 2013, the Company settled a dispute with a third party. Under the settlement, the Company was owed $1,000,000, payable through April 2015. The Company recognized the full amount of the settlement amount as a reduction to selling, general, and administrative expenses in the consolidated statements of operations for the six months ended 30 June 2013. As of 30 June 2014, the Company had received payments of $619,559 related to this settlement. As of 30 June 2015, the third party had paid the settlement in its entirety.

In addition to the aforementioned matter, the Company may experience litigation arising in the ordinary course of business. These claims are evaluated for possible exposure by management of the Company and their legal counsel.

Reclassifications: Certain prior year amounts have been reclassified to conform to the current year

presentation. These reclassifications had no effect on net income (loss) or stockholders' equity.

NOTE 2 - INVENTORIES

 
                                               2015        2014 
                                                US$         US$ 
                                         ----------  ---------- 
 Medical devices, parts, and solutions    5,814,709   4,677,868 
 Raw materials                            1,015,567   1,299,763 
                                         ----------  ---------- 
                                          6,830,276   5,977,631 
                                         ==========  ========== 
 

NOTE 3 - PROPERTY AND EQUIPMENT

 
                                                     2015          2014 
                                                      US$           US$ 
                                             ------------  ------------ 
 Property and equipment in progress               340,564       781,153 
 Computer equipment                               626,386       549,959 
 Furniture and fixtures                           832,946       874,847 
 Equipment under capital lease                    109,468        76,846 
 Laboratory equipment                           2,991,381     2,846,378 
 Leasehold improvements                         1,134,308     1,157,531 
 Tooling and moulds                             1,717,619       893,678 
 Vehicles                                         131,180       223,566 
                                             ------------  ------------ 
                                                7,883,852     7,403,958 
 Accumulated depreciation and amortisation    (4,599,393)   (3,847,044) 
                                             ------------  ------------ 
                                                3,284,459     3,556,914 
                                             ============  ============ 
 

During the six months ended 30 June 2015 and 30 June 2014, the Company recognised property and equipment depreciation and amortisation expense of $471,590 and $407,777 respectively.

NOTE 4 - INTANGIBLES

Intangible assets consist of the following:

 
                                          2015        2014 
                                           US$         US$ 
                                  ------------  ---------- 
 Licensing agreement                   141,931     141,931 
 Regulatory certification fees       1,133,242     629,606 
 Patents issued                      2,519,092   2,195,981 
 Patents pending                     2,229,582   1,999,596 
                                  ------------  ---------- 
                                     6,023,847   4,967,114 
 Less: Accumulated amortisation    (1,124,138)   (949,003) 
                                  ------------  ---------- 
                                     4,899,709   4,018,111 
                                  ============  ========== 
 

During the six months ended 30 June 2015 and 30 June 2014, the Company recognised intangible amortisation expense of $112,219 and $89,716, respectively. During the six months ended 30 June 2015 and 30 June 2014, the Company abandoned patents issued and patents pending with an original cost of $35,539 and $0, respectively.

NOTE 5 - LINE OF CREDIT AGREEMENT

During August 2009, the Company entered into a two-year working capital line of credit agreement with Silicon Valley Bank ("SVB") to support potential future cash needs of the Company. This line of credit agreement, and amendments in 2010, 2011, 2012, and 2013, provided for a revolving line of credit not to exceed an aggregate principal amount of $3,000,000, limited to qualifying receivables as defined, and granted a security interest in and lien upon all of the assets of Lifeline Scientific, Inc. and Organ Recovery Systems, Inc. in favour of SVB. The maturity of the line of credit agreement was 21 September 2014. The outstanding principal under the revolving line of credit accrued interest at an annual rate of 1.25% above the prime rate (3.25% as of 30 June 2014). During the six months ended 30 June 2014, the Company drew upon this line of credit in the amount of $1,000,000. In addition, a $750,000, 36 month term loan at a 5.50% unsecured or a 2.75% secured rate was made available to the Company. During the year ended 31 December 2012, the Company drew upon this term loan in the amount of $525,000 (at a secured rate of 2.75%) to support the Company's growth plans. The financing agreement was amended during the period ended 30 June 2013 to adjust the financial covenant requirement. The financing agreements contain financial covenants which require the Company to maintain a minimum tangible net worth (as defined). As of 30 June 2014, the Company was in compliance with all covenants.

On 18 September 2014, the Company entered into a new loan and security agreement with The PrivateBank and Trust Company ("PB"). The loan and security agreement provides for a revolving line of credit, not to exceed an aggregate principal amount of $6,000,000 but limited to qualifying receivables and inventories, as defined. The outstanding principal under the loan and security agreement accrues interest at PB's prime rate, as defined. The loan and security agreement contains financial covenants which require the Company to maintain a minimum tangible net worth, as defined, and a minimum fixed charge coverage ratio, as defined. The Company was in compliance with its financial covenants as of 30 June 2015. The loan and security agreement is secured by substantially all assets of the Company, and expires 17 September 2015. The Company used proceeds from the loan and security agreement to repay the outstanding principal of the prior line of credit agreement with SVB. Accordingly, the balances of $2,171,147 as of 30 June 2015 and $1,000,000 as of 30 June 2014 have been classified as short-term in the condensed consolidated balance sheets. PB has formal credit approval for the line of credit extension through 15 September 2016 with the remaining open items of legal documentation currently in process.

NOTE 6 - INCOME TAXES

At the end of its interim six month periods, the Company makes its best estimate of the annual expected effective income tax rate and applies that rate to its ordinary earnings or loss for each six month interim period. The income tax provision or benefit related to significant, unusual, or extraordinary items, if applicable, that will be separately reported or reported net of their related tax effects are individually computed and recognised in the six month interim period in which those items occur. In addition, the effect of changes in enacted tax laws or rates, tax status, judgment on the realisability of a beginning of the year tax asset in future years or income tax contingencies is recognised in the six month interim period in which the change occurs.

The computation of the annual expected effective income tax rate at each six month interim period requires certain estimates and assumptions including, but not limited to, the expected pre-tax loss for the year, projections of the proportion of loss taxed in foreign jurisdications, permanent and temporary differences, and the likelihood of the realisability of deferred tax assets generated in the current year. The accounting estimates used to compute the provision or benefit for income taxes may change as new events occur, more experience is acquired, additional information is obtained, or the Company's tax environment changes.

Income tax (benefit) consists of the following components:

 
                                           2015       2014 
                                            US$        US$ 
                                      ---------  --------- 
 Current (benefit) expense 
 Federal                               (27,739)   (40,254) 
 Foreign                                 10,936     17,117 
 State                                   20,000     20,000 
                                      ---------  --------- 
 Total income tax expense (benefit)       3,197    (3,137) 
                                      =========  ========= 
 

The net deferred tax assets (liabilities) in the accompanying consolidated balance sheets include the following components:

 
                                      2015           2014 
                                       US$            US$ 
                            --------------  ------------- 
 
 Deferred tax liabilities      (1,635,716)    (1,387,003) 
 Deferred tax assets            22,213,229     22,688,789 
                            --------------  ------------- 
 Net deferred tax assets        20,577,513     21,301,786 
 Valuation allowance          (17,237,828)   (19,262,101) 
                            --------------  ------------- 
 Net deferred tax assets         3,339,685      2,039,685 
                            ==============  ============= 
 

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