TIDMLSI TIDMLSIC

RNS Number : 7862S

Lifeline Scientific, Inc

29 September 2014

29 September 2014

Lifeline Scientific, Inc. ("Lifeline" or the "Company")

Results for the Six Months Ended 30 June 2014

Solid trading across products and regions

Lifeline Scientific, the transplantation technology company, announces results for the six months ended 30 June 2014. The results build upon growth that was achieved in 2013 and show planned improvement at the operating income line. The Company anticipates continued solid demand for Lifeline's products and services in the remainder of 2014.

Financial Highlights

   --      Transplantation products and services revenues up by 12.3% to US$14.8m (H1 2013: US$13.2m) 

-- North America revenues up 13.6% to US$12.0m (H1 2013: US$10.5m)

-- Revenue outside of North America up 7.3% to US$2.8m (H1 2013: US$2.7m) - representing 19.2% of total revenue (H1 2013: 20.1%)

-- LifePort proprietary consumables up 31.5% to US$8.5m (H1 2013: US$6.5m), contributing to an increase in gross margin to 62.0% (H1 2013: 55.4%)

   --      Gross profit up 24.4% to US$9.4m (H1 2013: US$7.5m) 
   --      Break-even operating results US$0.0m (H1 2013: US$1.4m loss) 
   --      Net cash provided by operating activities US$0.3m (H1 2013: US$1.8 net cash used) 
   --      Basic earnings per share during period of US$0.00 (H1 2013: US$0.07 loss) 
   --      Cash of US$2.5m as of 30 June 2014 (as of 31 December 2013: US$3.0m) 

Operational Highlights

   --      9 additional new transplant programme accounts were added: 2 in the US and 7 in Europe. 

-- The installed base of LifePorts reached 185 leading transplant programmes in 27 countries worldwide. (H1 2013: 155 programmes in 25 countries)

-- Sales of LifePort Kidney Transporters and related disposables in France increased by 212.8% to US$1.2m (H1 2013: US$0.4m)

-- Uptake of LifePort Kidney Transporter 1.1 strong with 54 sold during the period (H1 2013: 37)

David Kravitz, Chief Executive Officer of Lifeline, said:

"We continue to see the installed base of LifePorts expand and I am pleased to be able to report an overall 11.2% increase in revenues at an improved margin contributing to a solid set of results for the first half of the year. Our pipeline remains strong as is our full year outlook. Achievements during the first half of 2014 strengthened the Company's position in all of its key markets and gives us a solid platform for increasing LifePort's adoption throughout the world. We have continued to invest in capital and management resources aimed at accelerating revenues, profitability and shareholder value.

"We have been successful in advancing regulatory filings and approvals which will allow us to expand our geographic reach and support expansion in the key growth territories of the EU, Brazil, and soon China. The new generation of LifePort with available features such as GPS/GPRS capability has been very well received and will continue to help drive both product adoption and sales of single use consumables.

"Market growth will also be propelled by the expanding body of clinical evidence supporting the new generation of LifePort. We stay closely in touch with our customer communities of clinicians, patients and payors, and will continue to develop product innovations driven by their needs."

For further information please contact:

 
 Lifeline Scientific, Inc.                                  www.lifeline-scientific.com 
 David Kravitz, CEO                                                     +1 847 294 0300 
 
 Panmure Gordon (Nominated Adviser 
  and Broker)                                                       +44 (0)20 7886 2500 
 Freddy Crossley (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 is the market-leading and clinically validated LifePort Kidney Transporter. 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 provide improved kidney preservation, evaluation and transport prior to transplantation. Today, it is widely recognised as the world's leading machine preservation device for kidneys. Employed by surgeons in 187 major transplant centres in 27 countries worldwide, LifePorts have successfully preserved over 47,000 kidneys indicated for clinical transplant. For more information please visit www.organ-recovery.com

Lifeline Scientific, Inc. Shares

As a US Company listed on the London Stock Exchange's AIM exchange, Lifeline Scientific, Inc. trades under two lines of stock, AIM: LSIC (unrestricted shares), LSI (restricted shares). While affiliates of the Company are required to hold restricted (RegS) shares, all others may hold restricted or unrestricted shares. Unrestricted shares may be electronically traded through the CREST system. Both lines of stock have identical rights, preferences and privileges. Non-affiliates may transfer restricted shares to the unrestricted line after purchase through the Company's registrar. Total shares outstanding for the Company at this time are 19,446,720, with 13,085,806 shares in issue under the LSIC line and 6,360,914 shares in issue under the LSI line.

Chairman's Statement

Revenue from transplantation products was US$14.8m (H1 2013: US$13.2m), representing overall growth of 12.3%. Apart from China, which placed a large order toward year end 2013, we saw comparable period growth in all of our key territories. While we are still seeing importation related processing and permitting delays in Brazil, our pipeline there remains strong as is our full year outlook.

This period has been one of solid performance, as evidenced by a doubling of LifePort sales over the previous period (H1 2014: US$0.8m vs H1 2013: US$0.4m) and a 31.5% increase in sales of our LifePort proprietary disposables to US$8.5m (H1 2013: US$6.5m). We continue to establish the basis for solid growth in the second half of the year and beyond and have achieved operational breakeven for the period.

Single use consumables, which represent the bulk of worldwide sales, reached US$13.5m (H1 2013: US$12.2m). Demand has been strong worldwide for our upgraded LifePort Kidney Transporter featuring GPS/GPRS, leading to strong LifePort sales for the period.

Our installed base grew to 185 sites in 27 countries. As the installed base increases, we expect continued strong sales of the higher margin single use consumable items during the second half.

We are now making significant headway in supplying the French national tender which we were awarded in November 2013. The increased sales to France helped drive a 60.8% increase in LifePort proprietary disposable sales in Europe to US$1.7m (H1 2013: US$1.1m). We also saw sales to Brazil more than double to US$0.3m (H1 2013: US$0.1m) with a strong portfolio of demand in the pipeline for the second half of the year. In China, positive results continue to be reported from the 100 patient Ministry of Health sponsored clinical research study. Regulatory filings have been completed and we are optimistic that Chinese FDA registration approvals for our full product line of LifePort Kidney Transporter, single-use disposables and solutions could potentially issue by year end.

Gross margin increased to 62.0% (H1 2013: 55.4%), primarily as a consequence of product mix as we sold a larger proportion of higher margin single use disposables worldwide. Increased sales and stronger margins for the period resulted in breakeven performance at the operating results level of US$0.0m (H1 2013: loss of US$1.4m).

Net cash of US$0.3m was generated from operating activities (H1 2013: US$1.8m net cash used), directly related to improved operating income. Cash decreased in H1 2014 by US$0.5m compared to US$2.7m decrease in H1 2013 primarily due to investments in commercial tooling, regulatory and patent spending over the period, offset by reduced research and development spending as the LifePort Liver Transporter development program nears commercialization. Breakeven earnings per share was achieved (H1 2013: US$0.07 loss).

The cash position of the Company remains strong at period end US$2.5m (as at 31 December 2013: US$3.0m), US$1.5m net of a working capital revolver. The Company is pleased to report a recently negotiated bank facility with improved terms and a US$6.0m limit (previously US$3.0m) to support future growth as necessary. The first half of 2014 represents a very good start to the year and gives us a firm basis for continuing good performance in the second half.

John Garcia

Chairman

30 September 2013

Chief Executive Officer's review

We were encouraged to see growth in the key geographic markets that we have devoted considerable resources and finance to as part of our planned expansion strategy launched over 18 months ago.

Within these targeted markets, 9 new transplant programmes purchased LifePort as their machine preservation technology for clinical kidney transplantation. Regulatory and reimbursement efforts in several of these key markets also progressed, reflecting our strategic focus and investments over the last 18 months. In parallel, we achieved important milestones in the planned development of new products and market driven enhancements to several of our existing products. Uptake of the Company's all new LifePort Kidney Transporter 1.1 continued to be strong with 54 sold during the period. LifePort 1.1 features available GPS/GPRS technology, an upgraded digital user interface and faster data download capabilities.

Expanding to New Markets

Strategic Europe

LifePort adoptions continued to grow in Europe fuelled by strong early sales from the French national tender awarded to the Company in November 2013. Sales in France increased 212.8% as 24 LifePorts and 493 disposable sets were sold during the period in support of national protocols recommending machine preservation for all kidneys recovered from expanded criteria donors (ECD) and donors after cardiac death (DCD). There has been strong demand as well for LifePort's Rolling Transport Cover, a new innovation designed by the Company to comply with specific requirements of the French national tender. This new product has also found favour in other geographic markets, including the US.

Brazil

Brazil continues to show promise as another potentially significant geographic market for the Company. Health officials there report over 4,500 kidneys recovered annually from deceased donors, with significant demand for transplantation driven by rapidly growing population of end stage renal disease patients. Positive outcomes continue to be reported by Brazilian clinicians who have studied LifePort preservation vs. ice-boxed kidneys; clinical outcomes observed include significant reductions in delayed graft function (DGF), and hospital patient length of stay by transplant programmes now routinely using LifePort.

LifePort Kidney Transporters have been installed in eight leading Brazilian transplant centres, including Sao Paulo's prestigious Albert Einstein Hospital and Hospital Rim, the world's largest volume renal transplant centre.

Since receiving regulatory approvals in Brazil for our full suite of products, we have seen solid growth in demand. While we are still seeing importation related processing and permitting delays in Brazil, the pipeline of orders in process, anticipated bookings by year end, and tenders for solutions where the Company expects to be competitive is in excess of US$2.6m with an additional US$2.5m-US$4.5m of new business opportunities in ongoing discussions. Brazilian sales have more than doubled period over period to US$0.3m (H1 2013: US$0.1m).

China

China is a key potential growth market for the Company. Its organ donation and recovery practices are undergoing a major step-change mandated by the Chinese Health Ministry, patterned after successful national transplant systems and logistics management developed in the West. This shift is driving significant growth in donation of kidneys indicated for LifePort and by present market observations appears to be a growing trend.

Based on Chinese government projections of renal transplant demand (+1.5m end-stage renal disease patients on chronic dialysis), and the fact that machine preservation is indicated for the new "standard donor," China has potential to be the single largest national market opportunity in the world for LifePort and Lifeline's family of transplantation products. Chinese officials have stated that based upon actual and anticipated demand, China's renal transplant centers could grow from 165 locations today to nearly 300 in the next 3-5 years.

Over the past few years we have invested considerable effort in setting up key distributor and transplant centre relationships and now count 13 of China's largest transplant hospitals among those centres which are fully-trained and starting to employ LifePort under clinical research protocols. Additional positive clinical outcomes data has been reported from China's inaugural independent investigator driven multi-centre LifePort feasibility study. The 9 centre, 100 patient study was funded by Chinese Health Ministry grants and further study results are anticipated later this year. To date, over 500 LifePort preserved kidneys are estimated to have been successfully transplanted at Chinese transplant centres.

We have completed Chinese FDA (CFDA), required product testing and regulatory filings for our full suite of products and are in the end stage of CFDA file reviews. As full commercial market launch of LifePort Kidney Transporter in China awaits regulatory approvals, based on progress to date, the Company is optimistic these could issue before year-end 2014.

New Clinical Evidence

In the 15 January edition of Transplantation, Gill J et al reported results of 94,709 renal transplants in the US between 2000 and 2011 which were analysed with respect to DGF, after pulsatile perfusion (PP), and also DGF after cold static storage at varying cold ischemic times (CIT) with different donor groups. The authors concluded that perfusion is associated with a reduced risk of DGF irrespective of donor type and CIT. They also observed that while PP modifies the impact of CIT on the risk of DGF, it does not eliminate its association with DGF, suggesting the optimal strategy to reduce DGF is to minimize CIT and utilize PP in all deceased donor transplants. This retrospective study of close to 95,000 patients adds to the already significant body of evidence in the medical literature that machine preservation leads to improved patient outcomes by reducing delayed graft function across all types of deceased donor kidneys.

An abstract was presented at the World Transplant Congress in July by New York Presbyterian Hospital Columbia University Medical Center from a cohort clinical study of 31 "orphan" livers that had been transplanted after machine preservation on the LifePort prototype with the Company's novel liver preservation solution. Clinical outcomes observed included significant reductions in length of patient hospital stay, early allograft dysfunction and improved patient survival. In addition to the clinical benefits reported it was notable that the 31 machine preserved liver grafts had been turned down by other regional transplant centers and would have likely been discarded. Near-term publication in a prominent transplantation industry medical journal is expected.

In addition, a Columbia University Medical Center cost analysis of clinically transplanted livers preserved on the LifePort Liver Transporter prototype with the Company's novel machine preservation solution, showed statistically significant (p=0.02) cost savings vs. a matched cohort of livers that were preserved using static cold storage (ice-boxed livers). While derived from a single center experience, and confirmatory multi-center studies are planned, this preliminary information was encouraging showing a US$47,000 saving per patient with hypothermic machine perfusion versus cold storage (current practice). This data was presented at the winter meeting in January 2014 of the American Society of Transplant Surgeons (ASTS) whose author was recognized with a Young Investigator's Innovation Award.

New Product Innovations

With LifePort Liver Transporter's commercial design set, the Company is in process of regulatory registration for the US and Europe, while planning market access in China and Brazil. In addition, the Company is in discussions regarding potential grant funded product orders for humanitarian/clinical research use of LifePort Liver Transporter in certain countries, with a commercial launch planned in the US in H1 2015 subject to regulatory clearances. We have commenced commercial production of the LifePort Liver Transporter in preparation for orders and US FDA clearance.

We continue to gather clinical data from investigator driven controlled studies on early LifePort Liver Transporter prototypes conducted at New York Presbyterian Hospital Columbia University Medical Center. The data to-date suggests that LifePort Liver Transporter could represent a significant advancement in liver preservation. Potential benefits include improving patient outcomes and lowering the overall cost of transplantation. Published clinical data suggests our machine perfusion technology could also help enable the successful recovery of certain livers otherwise deemed not transplantable.

Sales of the Universal SealRing Cannula with novel ease-of-use features has commenced. Clinicians employing the Universal SealRing Cannula have commented on the new product's utility in facilitating the cannulation of kidney's with challenging vasculature that would otherwise render them unable to be connected to LifePort and thereby likely unusable for life saving transplantation. This invention also uniquely enables LifePort use with living donor kidneys, a potential new future market.

Grant funded development has progressed in line with expectations of novel point-of-care assays for monitoring of life-long immunosuppressant drug levels in transplant patients and ex-vivo biomarkers of an organ's health while undergoing LifePort machine preservation.

Supporting Growth

While the Company generated cash from operations of US$0.3m, cash for the period decreased US$0.5m, reflecting investments in the building of commercial production tooling, inventory, product development and financing national level regulatory, reimbursement and other market access efforts.

Outlook

Achievements during the first half of 2014 have given us a robust scientific and commercial base from which to expand the Company's efforts for continued regional and product line growth, and expansion to new geographic markets. Our installed base of LifePorts and related products is growing well in the key markets we identified for investment over 18 months ago, and I am particularly pleased that our focus in these markets is starting to deliver promising results.

Our strategy for continued growth is borne of closely listening to and working with the communities of transplant clinicians, patients and payors who we serve. As demand for life saving transplantation is large and rapidly growing worldwide, and supply of transplantable organs remains woefully inadequate, we are honored to play an active role in helping advance the quality and availability of these precious gifts of life.

Working to build shareholder value by improving outcomes in clinical transplantation is our dedicated mission.

David Kravitz

Chief Executive Officer

30 September 2014

LIFELINE SCIENTIFIC, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

30 June 2014 and 2013

(In US Dollars unless otherwise noted)

UNAUDITED

 
                                                               2014               2013 
 Current Assets 
 Cash and cash equivalents                         $      2,535,142   $      3,038,639 
 Receivables 
      Customers (net of allowance for doubtful 
       accounts of $0 and $2,673 as of 
       30 June 2014 and 2013, respectively)               6,899,704          3,990,003 
 Grant                                                       79,909             94,910 
 Deferred tax assets                                         97,472             16,285 
 Income taxes receivable                                          -             85,569 
 Inventories                                              5,977,631          5,464,444 
 Prepaid expenses, deposits, and other                    1,003,210          1,508,191 
                                                      -------------      ------------- 
 Total Current Assets                                    16,593,068         14,198,041 
 
 Non-current Assets 
 Property and equipment (net of accumulated 
  depreciation 
  and amortisation)                                       3,556,914          2,580,743 
 Intangibles (net of accumulated amortisation)            4,018,111          3,081,548 
 Deferred tax assets                                      1,942,213          1,023,400 
 Goodwill                                                    64,710             64,710 
 Other                                                       91,152            498,575 
                                                      -------------      ------------- 
 Total Non-current Assets                                 9,673,100          7,248,976 
 
 
 Total Assets                                      $     26,266,168   $     21,447,017 
                                                 ===  =============      ============= 
 Current Liabilities 
 Accounts payable                                  $      1,701,022   $      2,382,660 
 Income taxes payable                                        10,428                  - 
 Long-term debt due within one year                         470,118            260,958 
 Capital lease obligations due within one 
  year                                                       25,010              3,760 
 Accrued expenses 
      Interest due within one year                          185,247             48,553 
      Salaries and other compensation                       720,789            638,567 
      Other                                               1,100,228            812,698 
 Deferred rent                                               11,778            138,363 
 Deferred revenue                                            98,700            257,949 
                                                      -------------      ------------- 
 Total Current Liabilities                                4,323,320          4,543,508 
 
 Non-current Liabilities 
 Long-term debt (net of portion included 
  in current liabilities)                                 1,582,179          1,009,489 
 Deferred rent (net of portion included 
  in current liabilities)                                   372,398            248,917 
 Accrued interest (net of portion included 
  in current liabilities)                                   147,560            237,697 
 Capital leases (net of portion included 
  in current liabilities)                                    75,969              2,626 
                                                      -------------      ------------- 
 Total Non-current Liabilities                            2,178,106          1,498,729 
 
 Total Liabilities                                        6,501,426          6,042,237 
                                                      -------------      ------------- 
 
 Stockholders' Equity 
 Common stock, $0.01 par value; authorized 
  - 30,000,000 shares; issued and 
  outstanding - 19,453,613 and 19,424,959 
  shares as of 30 June 2014 and 2013, 
  respectively                                              194,536            194,249 
 Additional paid-in capital                              94,480,758         94,174,078 
 Other accumulated comprehensive loss                     (272,219)          (290,721) 
 Accumulated deficit                                   (73,472,398)       (77,671,782) 
                                                      -------------      ------------- 
 
 Total Lifeline Scientific, Inc. Stockholders' 
  Equity                                                 20,930,677         16,405,824 
                                                      =============      ============= 
 
 Non-controlling interest                               (1,165,935)        (1,001,044) 
 Total Stockholders' Equity                              19,764,742         15,404,780 
                                                      -------------      ------------- 
 
 Total Liabilities and Stockholders' Equity        $     26,266,168   $     21,447,017 
                                                 ===  =============      ============= 
 

LIFELINE SCIENTIFIC, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

Six months ended 30 June 2014 and 2013

(In US Dollars unless otherwise noted)

UNAUDITED

 
                                                              2014              2013 
 Net revenue 
 Product sales and service fee revenue              $   14,820,733   $    13,194,065 
 Grant revenue                                             297,242           396,594 
                                                       -----------      ------------ 
 Total net revenue                                      15,117,975        13,590,659 
 
 Cost of revenue                                         5,752,202         6,061,712 
                                                       -----------      ------------ 
 Gross profit                                            9,365,773         7,528,947 
                                                       -----------      ------------ 
 Gross profit percentage                                     62.0%             55.4% 
 Operating expenses 
     Research and development                            1,350,193         1,786,108 
     Selling, general, and administrative                8,024,491         7,178,011 
     Gain from disposal of property and 
      equipment                                              (697)                 - 
     Loss from abandonment of intangibles                        -             5,597 
                                                       -----------      ------------ 
 Total operating expenses                                9,373,987         8,969,716 
                                                       -----------      ------------ 
 
 Loss from operations                                      (8,214)       (1,440,769) 
                                                       -----------      ------------ 
 
 Other expense (income) 
     Interest expense                                       52,482            49,170 
     Interest income                                       (1,294)           (3,857) 
                                                       -----------      ------------ 
 Total other expense                                        51,188            45,313 
                                                       -----------      ------------ 
 
 Loss before income taxes                                 (59,402)       (1,486,082) 
 Income tax benefit                                        (3,137)          (72,236) 
                                                       -----------      ------------ 
 
 Net loss                                                 (56,265)       (1,413,846) 
 Less: net loss attributable to non-controlling 
  interest                                                  86,499           101,237 
                                                       -----------      ------------ 
 
 Net income (loss) attributable to Lifeline 
  Scientific, Inc.                                  $       30,234   $   (1,312,609) 
                                                  ===  ===========      ============ 
 
 Basic income (loss) per share                      $         0.00   $        (0.07) 
 Diluted income (loss) per share                              0.00           (0.07)* 
 
 Basic weighted average shares outstanding 
  (in shares)                                           19,445,881        19,424,959 
 Diluted weighted average shares outstanding 
  (in shares)                                           20,163,366        19,424,959 
 

* Diluted loss per share is the same as basic loss per share because the effects of potentially dilutive securities are anti-dilutive.

LIFELINE SCIENTIFIC, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

Six months ended 30 June 2014 and 2013

(In US Dollars unless otherwise noted)

UNAUDITED

 
                                                                2014              2013 
 
 Net loss                                               $   (56,265)   $   (1,413,846) 
 
 Foreign currency translation                               (18,509)          (40,438) 
                                                           ---------      ------------ 
 
 Comprehensive loss                                         (74,774)       (1,454,284) 
 
 Comprehensive loss attributable to non-controlling 
  interest                                                  (86,499)         (101,237) 
                                                           ---------      ------------ 
 
 Comprehensive income (loss) attributable 
  to Lifeline Scientific, Inc.                          $     11,725   $   (1,353,047) 
                                                      ===  =========      ============ 
 

LIFELINE SCIENTIFIC, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

Six months ended 30 June 2014 and 2013

(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 
  2013            $    16,730,465   19,424,959   $ 194,249   $ 94,045,479     $ (250,283)   $ (76,359,173)       $ (899,807) 
 Stock-based 
  compensation            128,599                        -        128,599               -                -                 - 
 Foreign currency 
  translation            (40,438)            -           -              -        (40,438)                -                 - 
 Net loss             (1,413,846)            -           -              -               -      (1,312,609)         (101,237) 
                     ------------  -----------  ----------  -------------  --------------  ---------------  ---------------- 
 
 Balance, 30 
  June 
  2013            $    15,404,780   19,424,959   $ 194,249   $ 94,174,078     $ (290,721)   $ (77,671,782)     $ (1,001,044) 
                ===  ============  ===========  ==========  =============  ==============  ===============  ================ 
 
 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) 
                ===  ============  ===========  ==========  =============  ==============  ===============  ================ 
 

LIFELINE SCIENTIFIC, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

Six months ended 30 June 2014 and 2013

(In US Dollars unless otherwise noted)

UNAUDITED

 
                                                           2014              2013 
 Cash flows from operating activities 
 Net loss                                       $      (56,265)   $   (1,413,846) 
 Adjustments to reconcile net loss to net 
  cash provided by 
  (used in) operating activities: 
 Depreciation and amortisation of property 
  and equipment                                         407,777           364,622 
 Amortisation of intangibles                             89,716            64,973 
 Settlement related to dispute with third 
  party                                                       -         (836,957) 
 Stock-based compensation                               154,318           128,599 
 Gain on disposal of property and equipment               (697)                 - 
 Loss on abandonment of intangibles                           -             5,597 
 (Increase) decrease in: 
      Receivables                                       957,015         1,417,219 
      Inventories                                     (642,536)       (1,058,133) 
      Prepaid expenses and deposits                     292,539             9,953 
      Other assets                                      269,317         (315,004) 
 Increase (decrease) in: 
      Accounts payable                                (399,550)            64,066 
      Accrued expenses                                (735,457)          (94,309) 
      Accrued interest                                  (9,671)          (40,731) 
      Deferred revenue                                   20,806          (48,510) 
      Deferred rent                                    (31,021)          (19,079) 
      Other liabilities                                   (238)                 - 
                                              ---  ------------      ------------ 
 Total adjustments                                      372,318         (357,694) 
                                                   ------------      ------------ 
 Net cash provided by (used in) operating 
  activities                                            316,053       (1,771,540) 
 Cash flows from investing activities 
 Payments related to intangible assets 
  and legal fees 
  associated with patent filings                      (492,677)         (339,298) 
 Capital expenditures                               (1,158,804)         (446,543) 
                                                   ------------      ------------ 
 Net cash used in investing activities              (1,651,481)         (785,841) 
 
 Cash flows from financing activities 
 Borrowings (repayments) under capital 
  lease obligations, net                                 34,298          (22,532) 
 Borrowings of long-term debt                         1,000,000                 - 
 Principal payments on long-term debt                 (174,178)          (87,500) 
 Net cash provided by (used in) financing 
  activities                                            860,120         (110,032) 
                                                   ------------      ------------ 
 Effect of foreign currency exchange rate 
  changes on cash                                      (11,690)          (40,354) 
 
 Net decrease in cash and cash equivalents            (486,998)       (2,707,767) 
 
 Cash and cash equivalents, beginning of 
  period                                              3,022,140         5,746,406 
                                                   ------------      ------------ 
 
 Cash and cash equivalents, end of period       $     2,535,142   $     3,038,639 
                                              ===  ============      ============ 
 

LIFELINE SCIENTIFIC, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

30 June 2014 and 2013

(In US Dollars unless otherwise noted)

UNAUDITED

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 2013.

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% owned

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 has an accumulated deficit as of 30 June 2014 and 2013.

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 classifies 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 all periods presented.

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 2014 and 30 June 2013 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 2014 and 2013.

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.

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 2013, 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 2014 and 2013, 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   -   Observable inputs that reflect unadjusted quoted 
  1           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   -   Observable market-based inputs or unobservable inputs 
  2           that are corroborated by market data. 
 Level   -   Unobservable inputs that are not corroborated by 
  3           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, and accounts payable approximates their fair values because of the short-term nature of these instruments. The carrying value of long-term debt approximates their fair values as the stated interest rates approximate current market interest rates of long-term debt 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 2014 and 2013 was $179,310 and $140,577, 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.

Shipping and Handling Costs: Shipping and handling costs billed to customers of $65,706 and $75,467 are netted with expense and have been included in cost of sales on the consolidated statements of operations during the six months ended 30 June 2014 and 2013, respectively.

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. As of 31 December 2013, $1,000,000 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 2014 and 2013, 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 2009 remain open to examination for both federal and state jurisdictions; for foreign jurisdictions the Company's tax years extending back to December 31, 2010 remain open for examination. The Company's policy is to recognise interest and penalties related to uncertain tax positions as a component of tax expense. During the six months ended 30 June 2014 and 2013, the Company did not recognise expense for interest and penalties. As of 30 June 2014 and 2013, the Company had $118,000 and $94,000, 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 indented 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.

Contingencies: During the six months ended 30 June 2013, the Company settled a dispute with a third party. Under the settlement, the Company is 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 and 2013, the third party was current with its payments to the Company, and the Company has received payments of $619,559 and $163,043, respectively, related to this settlement.

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. The Company believes that the ultimate resolution of any such matters will not have a material adverse effect on its consolidated financial position.

NOTE 2 - INVENTORIES

 
                                                 30 June         30 June 
                                                    2014            2013 
                                         --- 
 
 Medical devices, parts, and solutions     $   4,677,868   $   4,791,469 
 Raw materials                                 1,299,763         672,975 
                                              ----------      ---------- 
 
                                           $   5,977,631   $   5,464,444 
 ===========================================  ==========      ========== 
 

NOTE 3 - PROPERTY AND EQUIPMENT

 
                                                       30 June           30 June 
                                                          2014              2013 
                                             ---  ------------      ------------ 
 
 Property and equipment in progress            $       781,153   $       420,785 
 Computer equipment                                    549,959           363,604 
 Furniture and fixtures                                874,847           774,691 
 Equipment under capital lease                          76,846           135,524 
 Laboratory equipment                                2,846,378         1,934,675 
 Leasehold improvements                              1,157,531         1,053,841 
 Tooling and moulds                                    893,678           843,176 
 Vehicles                                              223,566           153,142 
                                                  ------------      ------------ 
                                                     7,403,958         5,679,438 
 
 Accumulated depreciation and amortisation         (3,847,044)       (3,098,695) 
                                                  ------------      ------------ 
 
                                               $     3,556,914   $     2,580,743 
 ===============================================  ============      ============ 
 

During the six months ended 30 June 2014 and 30 June 2013, the Company recognised property and equipment depreciation and amortisation expense of $407,777 and $364,622, respectively.

NOTE 4 - INTANGIBLES

Intangible assets consist of the following:

 
                                          30 June         30 June 
                                             2014            2013 
                                  ---  ----------      ---------- 
 
 Licensing agreement                $     141,931   $     141,931 
 Certification mark fees                  629,606               - 
 Patents issued                         2,195,981       1,600,243 
 Patents pending                        1,999,596       2,071,237 
                                       ----------      ---------- 
                                        4,967,114       3,813,411 
 Less: Accumulated amortisation         (949,003)       (731,863) 
                                       ----------      ---------- 
 
                                    $   4,018,111   $   3,081,548 
 ====================================  ==========      ========== 
 

During the six months ended 30 June 2014 and 30 June 2013, the Company recognised intangible amortisation expense of $89,716 and $64,973, respectively. During the six months ended 30 June 2014 and 30 June 2013, the Company abandoned patents issued and patents pending with an original cost of $0 and $5,597, 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, currently provide for a revolving line of credit not to exceed an aggregate principal amount of $3,000,000, limited to qualifying receivables as defined, and grants 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 is 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 and 2013, the Company was in compliance with all covenants.

On 19 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 will accrue 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 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, that balance of $1,000,000 as of 30 June 2014 has been classified as long-term debt in the condensed consolidated balance sheet.

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:

 
                                    30 June         30 June 
                                       2014            2014 
                             ---  ---------      ---------- 
 
 Current (benefit) expense 
 Federal                       $   (40,254)   $   (107,595) 
 Foreign                             17,117          15,359 
 State                               20,000          20,000 
                                  ---------      ---------- 
 
 Total income tax benefit      $    (3,137)   $    (72,236) 
                             ===  =========      ========== 
 

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

 
                                       30 June            30 June 
                                          2014               2013 
                            ---  -------------      ------------- 
 
 Deferred tax liabilities     $    (1,387,003)   $    (1,033,140) 
 Deferred tax assets                22,688,789         22,438,573 
                                 -------------      ------------- 
 Net deferred tax assets            21,301,786         21,405,433 
 Valuation allowance              (19,262,101)       (20,365,748) 
                                 -------------      ------------- 
 
 Net deferred tax assets      $      2,039,685   $      1,039,685 
                            ===  =============      ============= 
 

The income tax benefit differs from the federal statutory tax rate generally as a result of changes in each jurisdiction's valuation allowance and permanent differences, such as meals and entertainment expenses. A valuation allowance has been provided to reduce the deferred tax assets to the amount that is more likely than not to be realised.

As of 30 June 2014, the Company has federal and state net operating loss carryforwards totalling $57,712,000, which may be used to offset future taxable income. If not used, the carryforwards will expire as follows:

 
 Year                                   US $ 
--------------------------  ---  ----------- 
 2022                         $    2,366,000 
 2023                              7,720,000 
 2024                              6,412,000 
 2025                             11,136,000 
 2026                             12,197,000 
 2027                             14,131,000 
 2028                              3,750,000 
                                 ----------- 
 
 Total loss carryforwards     $   57,712,000 
                            ===  =========== 
 

As a result of changes in ownership at the IPO date, the Company estimates there will be future limitations on the utilisation of operating loss carryforwards pursuant to Internal Revenue Code Section 382. Any unused annual loss limitation carries forward to a future year. The annual limitation on loss carryforwards that could be utilised is approximately $2,600,000 after the six months ending 30 June 2014 and 30 June 2013. The cumulative unused loss limitation, which carried into the year ended 31 December 2013, was approximately $16,402,000.

NOTE 7 - STOCK OPTIONS

A summary of option activity under the Second Amended and Restated Stock Option and Restricted Stock Plan (the "2007 Plan") as of 30 June 2014 and 2013, and the changes during the six months ended 30 June 2014 and 2013 is as follows:

 
                                                 Weighted-      Weighted- 
                                                   Average        Average     Aggregate 
                                                  Exercise      Remaining     Intrinsic 
                                        Number       Price    Contractual         Value 
                                     of Shares         GBP           Term           GBP 
                                  ------------  ----------  -------------  ------------ 
 
 Outstanding as of 1 January 
  2013                               1,958,340        1.18           6.95     1,071,045 
 Granted                               219,000        1.90 
 Exercised                                   -           - 
 Forfeitures                           (1,125)        2.13 
                                  ------------ 
 Outstanding as of 30 June 2013      2,176,215        1.25           6.79     1,429,358 
                                  ============  ==========  =============  ============ 
 
 Outstanding as of 1 January 
  2014                               2,141,640        1.27 
 Granted                                     -           - 
 Exercised                             (8,800)        0.39 
 Forfeitures                           (1,375)        1.94 
 Expirations                           (4,000)        0.82 
                                  ------------ 
 Outstanding as of 30 June 2014      2,127,465        1.27           5.81     1,478,679 
                                  ============  ==========  =============  ============ 
 
 Vested or expected to vest 
  as of 30 June 2014                 2,114,763        1.27           5.80 
                                  ============  ==========  ============= 
 
 Options exercisable as of 30 
  June 2014                          1,753,113        1.13           5.37     1,461,284 
                                  ============  ==========  =============  ============ 
 

The Company recognised compensation expense of $154,318 and $128,599 for the six months ended 30 June 2014 and 2013, respectively. As of 30 June 2014, there was approximately $394,829 of total unrecognised compensation cost related to nonvested share-based compensation arrangements granted under the 2007 Plan. That cost is expected to be recognised over a weighted-average period of 0.9 years.

NOTE 8 - EARNINGS PER SHARE

Basic earnings per share is computed by dividing net income by the weighted average number of shares of common stock outstanding during the period. Diluted earnings per share include the dilutive effect of stock options and warrants, using the treasury stock method. The following table sets forth the computation of basic and diluted earnings per share for the six months ended 30 June 2014 and 2013:

 
                                                   30 June           30 June 
                                                      2014              2013 
                                          ---  -----------      ------------ 
 
 Net income (loss) attributed to common 
  stock shareholders                        $       30,234   $   (1,312,609) 
 Weighted average shares outstanding 
  for basic earnings per share                  19,445,881        19,424,959 
 Dilutive effect of stock options                  717,486                 - 
                                          ---  -----------      ------------ 
 
 Weighted average shares outstanding 
  for diluted earnings per share            $   20,163,366   $    19,424,959 
                                          ===  ===========      ============ 
 
 Basic income (loss) per share              $         0.00   $        (0.07) 
 Diluted income (loss) per share            $         0.00   $        (0.07) 
 

For the six months ended 30 June 2013, diluted loss per share is the same as basic loss per share because the effects of potentially dilutive securities are anti-dilutive.

NOTE 9 - RELATED PARTY TRANSACTIONS

During the year ended 31 December 2010, the Company entered into a consulting agreement with a company in which Steven Mayer, a member of the Company's Board of Directors, is a director. Mr. Mayer performed the consulting services. Fees for services rendered under the consulting agreement were $48,000 and $36,000 for the six months ended 30 June 2014 and 2013, respectively.

Additionally, during the six months ended June 2014 and 2013, the Company did business with a company in which David Kravitz and Steven Mayer are directors and have an ownership interest. Fees for research and development related products and services rendered were $351,000 and $214,500 for the six months ended 30 June 2014 and 2013, respectively. These payments represented expensed products and services of $171,000 and $22,500 for the six months ended 30 June 2014 and 2013, respectively, and asset purchases of $180,000 and $192,000, respectively.

This information is provided by RNS

The company news service from the London Stock Exchange

END

IR KMGZLKVVGDZM

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