RNS Number:2085Q
Medicsight Plc
17 March 2008
Press release 17 March 2008
Medicsight PLC
("Medicsight" or "the Company")
Preliminary Results for the 12 months ended 31 December 2007
Medicsight PLC (AIM: MDST), 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 Preliminary Results for the
twelve months ended 31 December 2007.
2007 Highlights
* Successful Initial Public Offering on the London AIM market, raising
�32 million before fees.
* The signing of updated distribution agreements with: Vital Images Inc.,
TeraRecon Inc., Viatronix Inc., and a new distribution agreement with
Barco NV.
* Regulatory approvals granted in Canada and Australia for ColonCAD(TM),
LungCAD(TM) and MedicRead Colon; and in Europe for MedicRead Colon.
* First commercial bookings for ColonCAD(TM).
Highlights post year end
* Preliminary Agreement with the Systems Integration (PACS) Division of
Toshiba for the resale of MedicRead Colon in Japan.
* Robust new product pipeline, with both horizontal and vertical
diversification into new and existing clinical areas.
* Regulatory interactions for product approvals with the US Food & Drug
Administration (FDA) and the Japanese Ministry of Health Labour and
Welfare (MHLW) progressing well.
* Strong balance sheet fundamentals should ensure the Company's ability
to deliver against key strategic objectives.
* Increasing adoption by national healthcare systems of computerised
tomography colonography (CTC) for the screening of colorectal cancer -
Medicsight well positioned to benefit from this trend.
David Sumner, Chief Executive of Medicsight PLC, commented: "We are delighted
with the progress made in 2007. It has been satisfying to see the Company
transform itself, on both corporate and operational fronts, into an entity that
is poised to capitalise on the fast growing and fast consolidating Health Care
Information Technology (HCIT) sector. Our commercial contract pipeline is very
strong and has been reinforced with the recent addition of a preliminary
agreement with Toshiba's PACS division in Japan. The forthcoming year will be
extremely important for Medicsight with the expected clearance from the FDA and
approval from the MHLW, which will unlock significant revenue. Medicsight has
proven itself to be capable of not only delivering pioneering and innovative
medical imaging software solutions, but also commercialising these products to
the benefit of the Company and its shareholders."
For further information, please contact:
Medicsight PLC
David Sumner +44 (0)20 7605 7950
www.medicsight.com
Collins Stewart Europe Limited
Tim Mickley +44 (0)20 7523 8350
Jonny Sloan +44 (0)20 7523 8302
Media enquiries:
Abchurch Tel: +44 (0) 20 7398 7700
Heather Salmond Tel: +44 (0) 20 7398 7704
heather.salmond@abchurch-group.com
Ashley Tapp Tel: +44 (0) 20 7398 7714
ashley.tapp@abchurch-group.com
Stephanie Cuthbert Tel: +44 (0) 20 7398 7718
stephanie.cuthbert@abchurch-group.com www.abchurch-group.com
Chairman's Statement
I am pleased to report that during 2007 the Company achieved a number of
important milestones which are detailed below. These include the admission of
the Company on the AIM market of the London Stock Exchange (MDST); the signing
of updated distribution agreements with our partners Vital Images Inc.,
TeraRecon Inc., and Viatronix Inc., and a new distribution agreement with Barco
NV; and the booking of Medicsight's first ColonCAD(TM) revenues.
The Company's main focus continues to be on developing Computer Aided Detection
("CAD") software applications that help clinicians analyse medical images
generated from Computerised Tomography ("CT") scanners for the early detection
of potential colonic polyps and lung nodules. In 2007 we made significant
progress with our ColonCAD(TM) product which we believe to be one of the leading
software solutions in the global medical imaging market.
Product Development in 2007
ColonCAD(TM)
During the year Medicsight's Research and Development Team made a number of
enhancements to ColonCAD(TM). These have resulted in a further improvement in
its detection rate of colonic polyps. According to a recent study, presented by
Dr Stuart Taylor (a consultant radiologist at London's University College
Hospital), at the annual Radiological Society of North America Conference,
ColonCAD(TM) has demonstrated a sensitivity of 85% for colonic polyps of size
5mm and larger, and 95% for polyps of 10mm and larger. Polyp size is the main
criterion for follow-up action after a positive CT Colonography ("CTC") finding;
polyps in the 6mm to 9mm range are monitored whist polyps with a diameter 10mm
or greater are recommended for optical colonoscopy follow-up and possible
removal. This is our most sensitive ColonCAD(TM) release to date and has been
integrated into the visualisation workstations of our partners. We believe that
this version of ColonCAD(TM) is one of the world's leading colon CAD software
solutions. The product has been developed and validated using a large database
of CT scans from hospitals around the world and has been assessed in many
clinical studies, the results of which have been published in peer-reviewed
publications and at leading radiology conferences.
LungCAD(TM)
In 2007 we enhanced our LungCAD(TM) software application, complementing our
LungCAD(TM)nodule detection and measurement tools with additional features to
create a disease management suite which we believe will meet the clinical needs
of lung imaging specialists.
The Company's ColonCAD(TM) and LungCAD(TM) products have been developed as
Application Programming Interfaces ("APIs") which can be seamlessly integrated
into our partners' advanced 3D visualisation workstations to provide a complete
visualisation solution.
MedicRead
In May 2007 we launched MedicRead Colon - which is Medicsight's own advanced
visualisation software application. MedicRead Colon can be deployed either on a
standalone basis or integrated into an existing clinical IT infrastructure. We
believe MedicRead Colon is a flexible option for hospitals and clinics unable to
invest large capital sums in new image analysis infrastructure. The next
version of this product will be released in 2008.
Financial review in 2007
The major financial event of 2007 was the completion of our Initial Public
Offering (IPO) and the admission of Medicsight shares on the AIM market of the
London Stock Exchange on 21 June 2007. The IPO raised �30.5 million of new
money after fees.
Following the IPO, the Company repaid in full the �5.7 million loan from our
parent company, MGT Capital Investments Inc., and terminated our �10 million
credit facility which had been unused since 2005.
The Company continues to keep a tight rein on expenditure and during 2007, has
improved its financial and non-financial procedures and structures in line with
our parent company's Sarbanes-Oxley compliance programme. Close monitoring of
costs and procedures will continue in 2008 whilst always ensuring that financial
resources are managed appropriately to enable the continuing growth and success
of the Company. At 31 December 2007 we had �25.2 million in cash and short term
deposits.
Regulatory approvals and submissions in 2007
At the beginning of 2007 the Company's ColonCAD(TM) and LungCAD(TM) products had
regulatory approval in the European Union (CE Marking).
During 2007 the Company was granted Medical Device Licenses from the Therapeutic
Products Directorate of Health Canada and from the Department of Health and
Ageing Therapeutic Goods Administration of Australia for ColonCAD(TM), LungCAD(TM)
and MedicRead Colon. Furthermore MedicRead Colon was granted CE Mark approval
in the European Union.
Applications are ongoing for FDA clearance in the USA and for regulatory
approval in China, Japan and Brazil. These are expected to be granted in 2008.
Commercialisation progress in 2007
In June 2007 Medicsight signed a distribution agreement with Barco NV who
successfully integrated ColonCAD(TM) into its Voxar 3D ColonMetrix application.
During the course of the year the Company renewed the agreements with three of
its existing distribution partners, Vital Images Inc., TeraRecon Inc., and
Viatronix Inc., who have all successfully integrated ColonCAD(TM) into their
visualisation software applications. LungCAD(TM) has also been integrated into
TeraRecon's Aquarius application and Viatronix's V3D visualisation software.
In addition to the above distribution agreements we have commercial discussions
in progress with other global partners that we expect to complete in 2008.
In 2007 Medicsight invested in the building of a Commercial team to support our
distribution partners in anticipation of successful outcomes to our regulatory
applications.
Clinical Activity in 2007
The Company's Clinical Development team continued their work with Medicsight's
global network of medical luminaries. Our ColonCAD(TM) application is involved
in a number of government-funded studies looking at the sensitivity of CTC and
the comparison of CTC with existing imaging methods for the early detection of
colorectal cancer.
The British Special Interest Group in Gastrointestinal and Abdominal Radiology
("SIGGAR") finished recruiting patients in November 2007 for the largest UK
randomised control trial to date. Medicsight's CAD is the only CAD product to
be involved in this trial, which compares CTC with two other widely-used imaging
approaches, Optical Colonoscopy and X-ray after a barium enema. The results of
this study are expected to be available in mid-2008.
The Medicsight ColonCAD(TM) software is also integrated into the visualisation
software used to read CTC examinations for the French STIC trial ("Sciences et
Technologies de l'Information et de la Communication" "Information and
Communication Science and Technology"). Recrui(TM)ent for this trial will
continue throughout 2008.
The Japanese National Cancer Centre in Tokyo has adopted Medicsight's
ColonCAD(TM) for the first CTC colon cancer screening programme in Japan.
There has also been significant progress in the USA in relation to the
acceptance of CTC into mainstream medical practice. In September 2007 the
American College of Radiology Imaging Network ("ACRIN") concluded a national
trial in the USA to clinically validate the widespread application of CTC as a
screening tool for the detection of colon cancer in at-risk populations. The
preliminary results have shown the benefits of CTC in both clinical and economic
terms. A further study conducted by the University of Wisconsin Medical Center,
the results of which were published in the New England Journal of Medicine in
October 2007, supported the use of CTC as a primary screening tool. On 5 March
2008, the American Cancer Society ("ACS") issued new Colorectal Cancer Screening
guidelines recommending that CTC be added to the panel of tests that physicians
have at their disposal when screening for colorectal cancer. The ACS
endorsement is expected to lead to routine reimbursement for CTC by third party
insurers and thereby to a material increase in the use of CTC for screening
those populations who are most at risk of developing this devastating condition.
CTC as a diagnostic examination for the early detection of colorectal cancer is
increasingly becoming accepted as mainstream clinical practice. The Virtual
Screening for Cancer Act 2007 was introduced in the US Congress in December
2007. If passed into law, this would allow CTC to form part of the US
Government's Medicare programme and under certain circumstances would allow full
reimbursement. This measure should increase the number of CTC examinations
performed in the USA and substantially increase the revenue opportunity for
Medicsight's ColonCAD(TM) product. The Company is monitoring this development
closely.
Medicsight's products have been profiled at major international radiology
conferences throughout 2007. The Company exhibited its ColonCAD(TM) and
MedicRead Colon applications at the Radiological Society of North America
("RSNA") annual meeting in Chicago in November 2007; the European Congress of
Radiology ("ECR") annual meeting in Vienna in March 2007; and the European
Society of Gastrointestinal and Abdominal Radiology ("ESGAR") in June 2007; as
well as exhibiting at other international radiology conferences.
In Japan, Medicsight supported, in cooperation with Toshiba Medical Systems
("Toshiba"), two CTC training workshops for radiologists at the Japanese
Radiological Society ("JRS"), the largest Japanese radiology congress, and the
Japan Digestive Disease Week ("JDDW") conference, the largest Japanese
gastroenterological conference. Within the training programmes, the
effectiveness of ColonCAD(TM) was demonstrated reflecting the way that it is
used at the Japanese National Cancer Centre, Tokyo. As a result of the success
of these workshops, additional training programmes are planned for 2008.
In 2007 Medicsight continued its support of education within the international
medical community by sponsoring US and European CTC workshops. These workshops
train radiologists to interpret CTC images using the latest visualisation and
CAD technology.
Significant events since December 2007
In February 2008 Medicsight announced it had signed a Preliminary Agreement with
the Systems Integration (PACS) Division of Toshiba Medical Systems ("Toshiba")
for the resale of MedicRead Colon in Japan.
Under this Preliminary Agreement, Toshiba has committed to work with the Company
to obtain Japanese Ministry of Health, Labour and Welfare ("MHLW") regulatory
approval for MedicRead Colon. This application was submitted in November 2007
and we anticipate will be granted during 2008.
Both the Company and Toshiba consider this to be the start of a long term
relationship for the development of CTC in Japan and both companies anticipate
capitalising on further commercial opportunities.
Conclusion
Medicsight made significant progress in 2007 and, as it enters 2008, has
maintained its reputation as one of the world's leading developers of CAD
software.
The Company maintains its competitive advantage and is protected by several
barriers to entry, including its patents and trademarks and its comprehensive CT
scan database of clinically verified CT scans. This is one of the world's
largest and most population diverse verified patient databases against which the
Medicsight software has been validated. Medicsight is also supported by the
strong clinical relationships it has developed with medical luminaries around
the world.
Following the IPO, Medicsight is in a strong financial position which enables us
to continue inves(TM)ent in research and development to bolster our expanding
product portfolio.
As your Chairman, I believe that your Company is in a very strong position in
2008 to capitalise on the achievements of 2007 and on behalf of the Board I
would like to thank you for your continuing support.
TIM PATERSON-BROWN
Chairman
17 March 2008
CONSOLIDATED INCOME STATEMENT
For the year ended 31 December 2007
2007 2006
�000 �000
(unaudited)
Revenue 20 -
Cost of sales - -
_____________ _____________
Gross profit 20 -
Sales & marketing expense (1,441) (806) *
Research & development expense (1,240) (1,161)
Administration expense (4,243) (3,720) *
Share based expense (831) (291) *
_____________ _____________
Operating loss (7,735) (5,978)
Finance revenue 803 63
Finance cost (71) 979
_____________ _____________
Loss before taxation (7,003) (4,936)
Income tax expense - -
_____________ _____________
Loss for the year (7,003) (4,936)
_____________ _____________
Loss per share (basic and diluted) (5p) (6p)
_____________ _____________
*Certain 2006 costs have been reclassified between administration expense, share
based expense and sales and marketing expense.
CONSOLIDATED BALANCE SHEET
As at 31 December 2007
2007 2006
�000 �000
(unaudited)
ASSETS
Current assets
Cash and short term deposits 25,246 6,164
Trade and other receivables 707 784
_____________ ______________
25,953 6,948
Non current assets
Property plant and equipment 176 130
_____________ _____________
Total assets 26,129 7,078
_____________ _____________
LIABILITIES
Current liabilities
Trade and other payables 1,671 1,300
Non current liabilities
Debt - 5,599
_____________ _____________
Total liabilities 1,671 6,899
_____________ _____________
Net assets 24,458 179
_____________ _____________
SHAREHOLDERS' EQUITY
Ordinary shares 7,776 6,322
Share premium 57,306 28,311
Share based payment reserve 1,236 405
Currency translation reserve (6) (23)
Retained earnings (41,854) (34,836)
______________ ______________
Total shareholders' equity 24,458 179
______________ ______________
CONSOLIDATED CASH FLOW STATEMENT
For the year ended 31 December 2007
2007 2006
�000 �000
(unaudited)
Cash flows from operating activities
Cash used in operations (6,349) (4,519)
Interest received 803 63
Interest paid (1,645) -
______________ ______________
Net cash from operating activities (7,191) (4,456)
______________ ______________
Cash flows from investing activities
Intercompany funding (15) -
Purchase of equipment (149) (127)
______________ ______________
Net cash used in investing activities (164) (127)
______________ ______________
Cash flows from financing activities
Net proceeds from issues of
ordinary share capital 30,449 6,292
Finance lease principal repayments (4) (10)
New borrowings - 353
Repayment of intercompany debt (4,025) -
______________ ______________
Net cash used in financing activities 26,420 6,635
______________ ______________
Effects of exchange rate changes 17 (15)
Net increase in cash and
cash equivalents 19,082 2,037
Cash and cash equivalents at 1 January 6,164 4,127
______________ ______________
Cash and cash equivalents at
31 December 25,246 6,164
______________ ______________
CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
For the year ended 31 December 2007
(unaudited) Share Share Share based Currency Retained Total
Capital Premium payment translation earnings Equity
reserve reserve
�000 �000 �000 �000 �000 �000
At 1 January 2006 4,322 11,019 114 (8) (29,900) (14,453)
Loss for the financial year - - - - (4,936) (4,936)
Net exchange adjus(TM)ents - - - (15) - (15)
_______ ________ _______ _________ __________ _________
Total recognised income and - - - (15) (4,936) (4,951)
expense
Equity settled share based - - 291 - - 291
payments
Nominal value of ordinary
shares issued 2,000 - - - - 2,000
Premium on ordinary shares issued - 18,000 - - - 18,000
Share issue costs - (708) - - - (708)
_______ ________ _______ _________ __________ _________
At 31 December 2006 6,322 28,311 405 (23) (34,836) 179
_______ ________ _______ _________ __________ _________
Loss for the financial year - - - - (7,003) (7,003)
Pre-acquisition retained loss - - - - (15) (15)
Net exchange adjus(TM)ents - - - 17 - 17
_______ ________ _______ _________ __________ _________
Total recognised income and - - - 17 (7,018) (7,001)
expense
Equity settled share based - - 831 - - 831
payments
Nominal value of ordinary
shares issued 1,454 - - - - 1,454
Premium on ordinary shares issued - 30,545 - - - 30,545
Share issue costs - (1,550) - - - (1,550)
_______ ________ _______ _________ __________ _________
At 31 December 2007 7,776 57,306 1,236 (6) (41,854) 24,458
_______ ________ _______ _________ __________ _________
NOTES TO PRELIMINARY RESULTS
The financial information set out above has been prepared in accordance with
International Financial Reporting Standards (IFRS) and those parts of the
Companies Act 1985 that remain applicable to companies reporting under IFRS and
does not constitute statutory accounts within the meaning of Section 240 of the
Companies Act 1985.
The Company's auditors have indicated that they intend to issue an unqualified
auditor's report, which will not contain any statement under Section 237(2) or
(3) of the Companies Act 1985, on the statutory financial statements for the
year ended 31 December 2007.
There have been no changes to the group accounting policies and the group has
followed the policies as previously published.
Loss per share and diluted loss per share
Loss per share is calculated by dividing the loss attributable to ordinary
shareholders for each year amounting to �7,003,000 (2006: �4,936,000) for the
year ended 31 December 2007 by 141,896,000 (2006: 86,872,000), being the
weighted average number of ordinary shares in issue during each year.
For the purposes of dilution, share options are non-dilutive.
This information is provided by RNS
The company news service from the London Stock Exchange
END
FR DGGMFGVLGRZZ
Medicsight (LSE:MDST)
Historical Stock Chart
From Jun 2024 to Jul 2024
Medicsight (LSE:MDST)
Historical Stock Chart
From Jul 2023 to Jul 2024
