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Press release |
8 August 2008 |
Medicsight PLC
("Medicsight" or "the Group")
Interim Results
For the Six Months Ended
30 June 2008
Medicsight PLC, industry leader in the development of Computer-Aided Detection (CAD) and image analysis software to assist in the early detection and diagnosis of disease, is pleased to announce its Interim Results for the six months ended 30 June 2008.
Highlights
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Preliminary Agreement with the Systems Integration (PACS) Division of Toshiba Medical Systems |
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Global Partnership Agreement with INFINITT Company Limited ("Infinitt") |
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Received Chinese State Food and Drug Administration (SFDA) regulatory approval for MedicRead Colon |
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Received Brazilian National Health Surveillance Agency (ANVISA) regulatory approval for MedicRead Colon and ColonCAD |
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Signed an exclusive CAD clinical research agreement with leading American CT colonography (CTC) radiologists Dr Perry Pickhardt and Dr David Kim |
David Sumner, Chief Executive of Medicsight PLC commented: "We are delighted with the progress the Company has made during the first half of 2008. We continue to bolster our contract pipeline adding the Toshiba PACS division and Infinitt to our list of distribution partners. Approvals continue to be received from regulatory bodies in China and Brazil who have recently cleared the MedicRead Colon and ColonCAD products for sale. In addition we are on track with the regulatory processes in Japan and the US. Finally and in line with expectations, Medicsight expects to launch its online MedicRead Colon solution and Lung and Liver applications at RSNA this year."
For further information, please contact:
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Medicsight plc |
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David Sumner |
+44 (0)20 7605 7950 |
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Nomura Code Securities Limited |
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Juliet Thompson, Managing Director |
+44 (0)20 7776 1200 |
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Jon Senior |
Media enquiries:
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Abchurch |
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Heather Salmond |
Tel: +44 (0) 20 7398 7700 Mob: +44 (0) 7855 018 606 |
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Stephanie Cuthbert |
Tel: +44 (0) 20 7398 7700 Mob: +44 (0) 7843 080947 |
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Chief Executive's Review
I am pleased to report our interim results for the six months ended 30 June 2008, Medicsight has achieved a number of key milestones and is making progress in line with the Company's expectations.
Commercial Partnerships
In February 2008, Medicsight signed a Preliminary Agreement with the Systems Integration (PACS) Division of Toshiba Medical Systems ("Toshiba") for the resale of MedicRead ColonCAD throughout Japan. The Company believes that this heralds the beginning of an on-going partnership with Toshiba, a leading global provider of diagnostic medical imaging systems and comprehensive medical solutions.
In April 2008, Medicsight signed a Partnership Agreement with INFINITT Company Limited ("Infinitt"). Infinitt has agreed to integrate Medicsight ColonCAD into its Colon solution for global distribution. As well as being South Korea's leading PACS supplier, Infinitt also has a growing presence in both the USA and Japan with a global network of offices, partners and sales channel representatives in 26 countries.
In addition to the agreements already signed, Medicsight is working to secure further contracts with other medical imaging companies to achieve wider distribution of its products.
Regulatory Approvals
In the six months ended 30 June 2008, Medicsight was granted regulatory approval for MedicRead Colon from the Chinese State Food and Drug Administration (SFDA) and the Brazilian National Health Surveillance Agency (ANVISA). More recently, the Company received Brazilian ANVISA regulatory approval for its ColonCAD product.
The Company is currently working to obtain Japanese Ministry of Health, Labour and Welfare (MHLW) regulatory approval for its MedicRead Colon product. Medicsight has engaged a team of experts to prepare the Company's application to secure US Food and Drug Administration (FDA) clearance. The Company is confident that it will shortly be in a position to file a 510(k) submission for review by the FDA.
Clinical Progress
In May 2008, the Company signed an exclusive CAD clinical research agreement with leading American CT colonography (CTC) radiologists Dr Perry Pickhardt and Dr David Kim from the University of Wisconsin Medical School, USA. In 2004, Dr Pickhardt's group was the first to establish a third-party reimbursed CT colonography colorectal cancer screening programme. Since then Drs Pickhardt and Kim have both played an instrumental role in building the clinical evidence base that has proven the comparable effectiveness of CTC for the detection of colorectal neoplasia within an asymptomatic population in relation to optical colonoscopy. Their specialist advice and experience of CTC practice will enhance the clinical validation of Medicsight's Colon CAD products set in the context of the world's largest healthcare market.
In June 2008, data presented at the European Society of Gastrointestinal and Abdominal Radiology (ESGAR) 2008 Conference found that Medicsight's ColonCAD technology assisted radiographers in identifying 100% of the cancers within the study group.
Product Development
The Medicsight product roadmap continues on track enabling 2008 launches of MedicRead Colon 3.0, MedicRead Lung 1.0 and MedicRead Liver 1.0 as well as an online CTC software solution based on MedicRead Colon. Medicsight is continuing to improve the performance of its ColonCAD product with a new version planned for 2009. In addition, the company has initiated the development of a CO2 insufflation device for CTC (MedicCO2lon) and is exploring new image processing and analysis tools for optical colonoscopy. These additions will bolster the existing CTC portfolio.
Financial Review
Revenue for the six months ended 30 June 2008 was £44,000 compared with £nil for the six months ended 30 June 2007.
In the six months ended 30 June 2008, the Company spent a total of £4,892,000 on operating costs compared with £3,566,000 for the six months ended 30 June 2007, which is in line with company expectations.
Medicsight remains in a strong financial position with the funds available to execute the business plan.
Conclusion
Medicsight continues to make progress in line with the Company's expectations. In the first half of 2008, we have achieved a number of significant milestones and laid the foundations for further successes. With significant financial resources at the Company's disposal, Medicsight is well positioned for the product rollout in 2009 and beyond.
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David Sumner |
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Chief Executive Officer |
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8 August 2008 |
INTERIM FINANCIAL STATEMENTS
CONSOLIDATED INCOME STATEMENTS
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6 months ended 30 June 2008 |
6 months ended 30 June 2007 |
Year ended 31 December 2007 |
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(unaudited) |
(unaudited) |
(audited) |
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£000 |
£000 |
£000 |
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Revenue |
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License and support fees |
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44 |
- |
20 |
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Cost of sales |
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- |
- |
- |
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________ |
________ |
________ |
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Gross profit |
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44 |
- |
20 |
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________ |
________ |
________ |
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Sales and marketing expense |
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(696) |
(492) |
(1,441) |
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Administrative expenses |
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(3,005) |
(2,043) |
(4,243) |
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Research and development |
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(574) |
(553) |
(1,240) |
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Share based expense |
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(617) |
(478) |
(831) |
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________ |
________ |
________ |
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Operating loss |
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(4,848) |
(3,566) |
(7,735) |
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________ |
________ |
________ |
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Finance income |
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371 |
39 |
732 |
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________ |
________ |
________ |
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Loss before taxation |
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(4,477) |
(3,527) |
(7,003) |
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________ |
________ |
________ |
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Taxation |
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- |
- |
- |
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________ |
________ |
________ |
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Loss on ordinary activities after taxation attributable to equity holders of the parent |
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(4,477) |
(3,527) |
(7,003) |
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________ |
________ |
________ |
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Loss per share - basic and diluted |
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(3p) |
(3p) |
(5p) |
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________ |
________ |
________ |
The notes on pages 10 to 14 form part of these interim financial statements.
INTERIM FINANCIAL STATEMENTS
CONSOLIDATED BALANCE SHEETS
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30 June 2008 |
30 June 2007 |
31 December 2007 |
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(unaudited) |
(unaudited) |
(audited) |
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£000 |
£000 |
£000 |
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ASSETS |
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Non current assets |
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Property plant and equipment |
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221 |
103 |
176 |
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________ |
________ |
________ |
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221 |
103 |
176 |
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________ |
________ |
________ |
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Current assets |
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Trade and other receivables |
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1,033 |
904 |
707 |
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Marketable securities and treasury deposits |
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1,076 |
- |
- |
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Cash and cash equivalents |
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20,314 |
27,928 |
25,246 |
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________ |
________ |
________ |
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22,423 |
28,832 |
25,953 |
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________ |
________ |
________ |
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Total assets |
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22,644 |
28,935 |
26,129 |
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________ |
________ |
________ |
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LIABILITIES |
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Current liabilities |
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Trade and other payables |
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(2,007) |
(1,310) |
(1,671) |
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________ |
________ |
________ |
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Total liabilities |
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(2,007) |
(1,310) |
(1,671) |
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________ |
________ |
________ |
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Net assets |
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20,637 |
27,625 |
24,458 |
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________ |
________ |
________ |
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SHAREHOLDERS' EQUITY |
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Ordinary shares |
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7,776 |
7,776 |
7,776 |
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Share premium |
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57,306 |
57,306 |
57,306 |
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Share based payment reserve |
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1,853 |
883 |
1,236 |
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Currency translation reserve |
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33 |
23 |
(6) |
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Retained earnings |
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(46,331) |
(38,363) |
(41,854) |
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________ |
________ |
________ |
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Equity attributable to equity holders of the parent |
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20,637 |
27,625 |
24,458 |
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________ |
________ |
________ |
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INTERIM FINANCIAL STATEMENTS
CONSOLIDATED CASH FLOW STATEMENTS
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6 months |
6 months |
Year ended |
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(unaudited) |
(unaudited) |
(audited) |
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£000 |
£000 |
£000 |
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Cash flows from operating activities |
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Cash used in operations |
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(4,157) |
(3,145) |
(6,349) |
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Interest received |
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371 |
110 |
803 |
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Interest paid |
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- |
(1,645) |
(1,645) |
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________ |
________ |
________ |
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Net cash from operating activities |
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(3,786) |
(4,680) |
(7,191) |
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________ |
________ |
________ |
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Cash flows from investing activities |
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Purchase of equipment |
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(106) |
- |
(149) |
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Other movement |
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- |
- |
(15) |
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Proceeds on sale of equipment |
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- |
(22) |
- |
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Purchase of marketable securities |
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(574) |
- |
- |
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Investment in treasury deposits |
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(502) |
- |
- |
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________ |
________ |
________ |
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Net cash used in investing activities |
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(1,182) |
(22) |
(164) |
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________ |
________ |
________ |
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Cash flows from financing |
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Net proceeds from issues of |
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ordinary share capital |
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- |
30,449 |
30,449 |
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Finance lease principal repayments |
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- |
(4) |
(4) |
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Repayment of borrowings |
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- |
(4,025) |
(4,025) |
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________ |
________ |
________ |
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Net proceeds financing activities |
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- |
26,420 |
26,420 |
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________ |
________ |
________ |
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Net (decrease)/increase in cash and |
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cash equivalents |
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(4,968) |
21,718 |
19,065 |
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Effects of exchange rate changes |
|
36 |
46 |
17 |
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|
|
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Cash and cash equivalents at 1 January |
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25,246 |
6,164 |
6,164 |
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Cash and cash equivalents |
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________ |
________ |
________ |
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at period end |
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20,314 |
27,928 |
25,246 |
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________ |
________ |
________ |
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INTERIM FINANCIAL STATEMENTS
CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
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Share |
Share Premium |
Share based payment reserve |
Currency translation reserve |
Retained earnings |
Total Equity |
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£000 |
£000 |
£000 |
£000 |
£000 |
£000 |
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|
|
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At 1 January 2007 |
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6,322 |
28,311 |
405 |
(23) |
(34,836) |
179 |
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Loss for the period |
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- |
- |
- |
- |
(3,527) |
(3,527) |
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Net exchange adjustments |
|
- |
- |
- |
46 |
- |
46 |
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________ |
________ |
________ |
________ |
________ |
________ |
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Total recognised income and expense |
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- |
- |
- |
46 |
(3,527) |
(3,481) |
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________ |
________ |
________ |
________ |
________ |
________ |
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|
|
|
|
|
|
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Share based payments |
|
- |
- |
478 |
- |
- |
478 |
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Ordinary shares issued |
|
1,454 |
- |
- |
- |