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Medicsight Interim Results For the Six Months Ended 30 June 2009

Medicsight PLC

("Medicsight" or "the Group")

Interim Results

for the six months ended 30 June 2009

 

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 2009.

Highlights

  •  

Responded to the US Food & Drug Administration's (FDA) Additional Information request letter in March 2009.

  •  

Launched ColonCAD™ 4.0 which is CE Marked and has received approval from the Therapeutic Products Directorate of Health Canada.

  •  

Launched MedicRead 3.0 Colon in June, available in Europe as an online CTC solution.

  •  

Global software licence and distribution agreement with Alma IT Systems.

  •  

Streamlined the business to reduce costs and conserve cash.

  •  

Group cash balance at 30 June 2009 of £13,746,000.

 

Allan Rowley, Chief Executive of Medicsight PLC commented: "Medicsight has expanded its product portfolio with the launch of ColonCAD 4.0 and MedicRead 3.0 Colon. Both products have significant improvements over previous versions and have been CE marked for use in Europe. ColonCAD 4.0 has also been approved in Canada. The Group completed a cost reduction program to streamline operating costs and conserve its cash position. Medicsight is well positioned for the second half of 2009 and beyond."

 

For further information, please contact:

Medicsight PLC

 

Allan Rowley

+44 (0)20 7605 7950

 

www.medicsight.com

Daniel Stewart & Company PLC

 

Simon Leathers / Charlotte Stranner

+44 (0)20 7776 6550

 

 

 

Media enquiries:

 

Abchurch

 

Heather Salmond

heather.salmond@abchurch-group.com

Tel: +44 (0) 20 7398 7700

Mob: +44 (0) 7855 018 606

 

 

Stephanie Cuthbert

stephanie.cuthbert@abchurch-group.com

Tel: +44 (0) 20 7398 7700

Mob: +44 (0) 7843 080947

 

www.abchurch-group.com

 

Chief Executive's Review

I am pleased to report Medicsight's interim results for the six months ended 30 June 2009.

 

Commercial Partnerships

In June 2009 Medicsight signed a non-exclusive software license and distribution agreement with Alma IT Systems (Alma), for the integration of Medicsight's ColonCAD API 4.0 software into Alma's 3D visualisation workstation. Alma is one of Spain's market leaders in medical imaging technology with a large and well-established installed base of radiology customers. We expect sales to commence before the end of the year.

 

Product Development & Regulatory Approvals

The Company submitted a 510(k) application to the US Food & Drug Administration (FDA) for ColonCAD 3.1 in November 2008. In December 2008, Medicsight received an Additional Information request letter and, after close collaboration with its FDA advisers, sent a comprehensive response in March 2009. We are currently awaiting feedback from the FDA on the status of our application.

 

In November 2007 the Company submitted an application for MedicRead 1.0 to the Ministry of Health, Labour and Welfare (MHLW) of Japan. We recently had a meeting with the MHLW authorities, and are in the process of responding to their queries, and await their feedback.

 

Medicsight's product development program continues on track. In the six months ended 30 June 2009 the Group released ColonCAD 4.0, the most accurate version of the Medicsight ColonCAD to date. The updated software demonstrates a 50% reduction in the number of false positive CAD markings per patient case, whilst maintaining high levels of sensitivity for the detection of colorectal polyps. ColonCAD 4.0 has been granted regulatory approval in Europe (CE marked) and also from the Therapeutic Products Directorate of Health Canada.

 

The Group also launched MedicRead 3.0 Colon, Medicsight's CAD-enabled CT colonography reviewing tool, which is available online via the Medicsight website (www.medicsight.com). MedicRead 3.0 Colon has been CE marked, and other regulatory approvals are in progress.

As part of a CTC scan examination, the patient's colon has to be distended with gas or air to enable accurate imaging diagnosis. Following market demand, Medicsight has started development of a CO2 insufflation device, MedicCO2lon, for this purpose. The Group is also exploring new image processing and analysis tools for optical colonoscopy. Both of these new applications will bolster the existing CTC portfolio.

 

Clinical Progress

Doctors Perry Pickhardt and David Kim (from the University of Wisconsin Medical School, in the United States) are undertaking a retrospective comparative analysis of Medicsight's ColonCAD 4.0 performance against the performance of expert radiologists interpreting CTC image data. Early results from this study of more than 3,000 patient datasets show excellent ColonCAD performance and more detailed study results are expected to be presented later in 2009.

 

Clinical research incorporating Medicsight's ColonCAD was published in the peer-reviewed American Journal of Roentgenology in June 2009. The Group, in collaboration with Dr. Stuart Taylor (of University College Hospital, London) also received notice in July of acceptance of a second peer-reviewed paper for publication in Radiology journal.

 

Both these studies demonstrate the positive benefit of Medicsight's ColonCAD to radiologists when interpreting CT colonography datasets.

 

Financial Review

Revenue for the six months ended 30 June 2009 was £67,000 (2008: £44,000).

In line with management's expectations the Group incurred total operating costs of £4,913,000 in the six months to June 30 2009 (2008: £4,892,000). Research and development costs were higher in the period due to a renegotiation of terms with a development partner.

 

Following the streamlining of business operations and reduction of headcount earlier in the year, Medicsight remains in a strong financial position with cash and cash equivalents of £13,746,000 and expects future operating costs to be significantly lower as we realise the full benefit of the cost reduction program.

 

Conclusion

With significant financial resources at the Group's disposal Medicsight continues to make progress on all fronts and is well positioned for the second half of 2009 and beyond.

 

Allan Rowley

Chief Executive Officer

 

14 August 2009

INTERIM FINANCIAL STATEMENTS

CONSOLIDATED INCOME STATEMENTS

 

 

 

 

6 months ended

30 June 2009

6 months ended

30 June 2008

Year ended

31 December 2008

 

 

(unaudited)

(unaudited)

(audited)

 

 

£000

£000

£000

 

 

 

 

 

Revenue

 

 

 

 

License and support fees

 

67

44

103

Cost of sales

 

-

-

-

 

 

________

________

________

Gross profit

 

67

44

103

 

 

________

________

________

 

 

 

 

 

Sales and marketing expense

 

(724)

(696)

(2,095)

Administrative expenses

 

(2,970)

(3,005)

(5,839)

Research and development

 

(860)

(574)

(1,822)

Share-based expense

 

(359)

(617)

(1,253)

 

 

________

________

________

Operating loss

 

(4,846)

(4,848)

(10,906)

 

 

________

________

________

 

 

 

 

 

Finance income

 

37

371

2,664

 

 

________

________

________

Loss before taxation

 

(4,809)

(4,477)

(8,242)

 

 

 

 

 

Taxation

 

-

-

-

 

 

________

________

________

Loss on ordinary activities after taxation attributable to equity holders of the parent

 

(4,809)

(4,477)

(8,242)

 

 

________

________

________

 

 

 

 

 

Loss per share - basic and diluted

 

(3p)

(3p)

(5p)

 

 

________

________

________

INTERIM FINANCIAL STATEMENTS

CONSOLIDATED BALANCE SHEETS

 

 

 

 

30 June 2009

30 June 2008

31 December 2008

 

 

(unaudited)

(unaudited)

(audited)

 

 

£000

£000

£000

 

 

 

 

 

ASSETS

 

 

 

 

Non-current assets

 

 

 

 

Property, plant and equipment

 

180

221

273

 

 

________

________

________

 

 

180

221

273

 

 

________

________

________

 

 

 

 

 

Current assets

 

 

 

 

Trade and other receivables

 

890

1,033

1,298

Marketable securities and treasury deposits

 

-

1,076

-

Cash and cash equivalents

 

13,746

20,314

18,387

 

 

________

________

________

 

 

14,636

22,423

19,685

 

 

________

________

________

 

 

 

 

 

Total assets

 

14,816

22,644

19,958

 

 

________

________

________

 

 

 

 

 

LIABILITIES

 

 

 

 

Current liabilities

 

 

 

 

Trade and other payables

 

(1,791)

(2,007)

(2,483)

 

 

________

________

________

Total liabilities

 

(1,791)

(2,007)

(2,483)

 

 

________

________

________

 

 

 

 

 

Net assets

 

13,025

20,637

17,475

 

 

________

________

________

 

 

 

 

 

SHAREHOLDERS' EQUITY

 

 

 

 

Ordinary shares

 

7,776

7,776

7,776

Share premium

 

57,306

57,306

57,306

Share-based payment reserve

 

2,848

1,853

2,489

Currency translation reserve

 

-

33

-

Retained earnings

 

(54,905)

(46,331)

(50,096)

 

 

________

________

________

Equity attributable to equity holders of the parent

 

13,025

20,637

17,475

 

 

________

________

________

 

 

 

 

 

 

INTERIM FINANCIAL STATEMENTS

CONSOLIDATED CASH FLOW STATEMENTS

 

 

 

 

6 months
ended

30 June 200
9

6 months
ended
30 June 2008

Year ended
31 December

2008

 

 

(unaudited)

(unaudited)

(audited)

 

 

£000

£000

£000

 

 

 

 

 

Cash flows from operating activities

 

 

 

 

Cash used in operations

 

(4,700)

(4,157)

(9,437)

Interest received

 

-

371

-

 

 

________

________

________

Net cash from operating activities

 

(4,700)

(3,786)

(9,437)

 

 

________

________

________

 

 

 

 

 

Cash flows from investing activities

 

 

 

 

Purchase of equipment

 

(7)

(106)

(207)

Interest received

 

37

-

2,672

Purchase of marketable securities

 

-

(574)

(890)

Sale of marketable securities

 

-

-

1,030

Investment in treasury deposits

 

-

(502)

-

 

 

________

________

________

Net cash used in investing activities

 

30

(1,182)

2,605

 

 

________

________

________

 

 

 

 

 

Effects of exchange rate changes

 

29

36

(27)

 

 

________

________

________

Net (decrease) in cash and

 

 

 

 

cash equivalents

 

(4,641)

(4,932)

(6,859)

 

 

 

 

 

Cash and cash equivalents at 1 January

 

18,387

25,246

25,246

 

 

 

 

 

Cash and cash equivalents

 

________

________

________

at period end

 

13,746

20,314

18,387

 

 

________

________

________

 

 

 

 

 

 

INTERIM FINANCIAL STATEMENTS

CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY

 

 

 

Share
Capital

Share
Premium

Share-based payment reserve

Currency translation reserve

Retained earnings

Total
Equity

 

 

£000

£000

£000

£000

£000

£000

 

 

 

 

 

 

 

 

At 1 January 2008

 

7,776

57,306

1,236

(6)

(41,854)

24,458

Loss for the period

 

-

-

-

-

(4,477)

(4,477)

Net exchange adjustments

 

-

-

-

39

-

39

 

 

________

________

________

________

________

________

Total recognised income and expense

 

-

-

-

39

(4,477)

(4,438)

 

 

 

 

 

 

 

 

Share-based payments

 

-

-

617

-

-

617

 

 

________

________

________

________

________

________

At 30 June 2008

 

7,776

57,306

1,853

33

(46,331)

20,637

Loss for the period

 

-

-

-

-

(3,765)

(3,765)

Net exchange adjustments

 

-

-

-

(33)

-

(33)

 

 

________

________

________

________

________

________

Total recognised income and expense

 

-

-

-

(33)

(3,765)

(3,798)

 

 

 

 

 

 

 

 

Share-based payments

 

-

-

636

-

-

636

 

 

________

________

________

________

________

________

At 31 December 2008

 

7,776

57,306

2,489

-

(50,096)

17,475

Loss for the period

 

-

-

-

-

(4,809)

(4,809)

Net exchange adjustments

 

-

-

-

-

-

-

 

 

________

________

________

________

________

________

Total recognised income and expense

 

-

-

-

-

(4,809)

(4,809)

 

 

 

 

 

 

 

 

Share-based payments

 

-

-

359

-

-

359

 

 

 

 

 

 

 

 

 

 

________

________

________

________

________

________

At 30 June 2009

 

7,776

57,306

2,848

-

(54,905)

13,025

 

 

________

________

________

________

________

________

NOTES TO INTERIM FINANCIAL STATEMENTS

 

1. Basis of preparation of interim financial information

 

These interim consolidated financial statements are for the six months ended 30 June 2009. The interim financial report, which is unaudited, has been prepared in accordance with the recognition and measurement criteria of International Financial Reporting Standards and IFRIC interpretations adopted for use in the European Union (IFRS). The accounting policies and methods of computation used are consistent with those used in the Group annual report for the year ended 31 December 2008 and are expected to be used in the Group Annual Report for the year ended 31 December 2009. The six month period figures have not been audited.

 

The financial information for the year ended 31 December 2008 does not constitute statutory information. A copy of the statutory accounts for that year has been delivered to the Registrar of Companies. The auditors' report on these accounts was not qualified and did not contain statements under section 237(2) and (3) of the Companies Act 1985.

 

The interim consolidated financial statements are presented in pounds sterling because that is the currency of the primary economic environment in which the group operates. All values are rounded to the nearest thousand pounds (£000) except when otherwise stated.

 

NOTES TO INTERIM FINANCIAL STATEMENTS

 

2. Segmental geographical reporting

 

The Group operates in one business area which is the development and commercialisation of medical imaging software.

Operating results are reported to the Group's chief operating decision maker on a geographical basis. The following reports financial information on a geographical basis and reconciles it to the Group's results.

 

 

 

 

UK & Europe

£000

Japan

£000

USA

£000

All other segments

£000

Total

£000

 

 

________

________

________

________

________

6 months ended

30 June 2009

 

 

 

 

 

 

Revenue

 

67

-

-

-

67

Interest receivable

 

37

-

-

-

37

Depreciation

 

34

37

-

-

71

Share-based expense

 

312

15

32

-

359

Loss before tax

 

(3,886)

(687)

(10)

(226)

(4,809)

 

 

 

 

 

 

 

Non-current assets

 

47

133

-

-

180

Total assets

 

14,388

369

-

59

14,816

Total liabilities

 

(1,627)

(25)

(59)

(80)

(1,791)

 

 

________

________

________

________

________

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

UK & Europe

£000

Japan

£000

USA

£000

All other segments

£000

Total

£000

 

 

________

________

________

________

________

6 months ended

30 June 2008

 

 

 

 

 

 

Revenue

 

44

-

-

-

44

Interest receivable

 

371

-

-

-

371

Depreciation

 

41

23

-

-

64

Share-based expense

 

552

20

45

-

617

Loss before tax

 

(3,226)

(496)

(334)

(421)

(4,477)

 

 

 

 

 

 

 

Non-current assets

 

70

151

-

-

221

Total assets

 

22,287

337

-

20

22,644

Total liabilities

 

(1,683)

(39)

(49)

(236)

(2,007)

 

 

________

________

________

________

________

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

UK & Europe

£000

Japan

£000

USA

£000

All other segments

£000

Total

£000

 

 

________

________

________

________

________

12 months ended

31 December 2008

 

 

 

 

 

 

Revenue

 

103

-

-

-

103

Interest receivable

 

2,664

-

-

-

2,664

Depreciation

 

82

61

-

-

143

Share-based expense

 

1,122

35

96

-

1,253

Loss before tax

 

(5,527)

(1,002)

(1,291)

(422)

(8,242)

 

 

 

 

 

 

 

Non-current assets

 

78

195

-

-

273

Total assets

 

19,394

510

-

54

19,958

Total liabilities

 

(1,974)

(56)

(148)

(305)

(2,483)

 

 

________

________

________

________

________

 

 

 

 

 

NOTES TO INTERIM FINANCIAL STATEMENTS

 

3. Earnings per share

 

 

 

 

6 months ended

30 June 2009

6 months ended

30 June 2008

Year ended

31 December 2008

 

 

(unaudited)

(unaudited)

(audited)

 

 

______________

______________

______________

 

 

 

 

 

 

 

 

 

 

Loss for the period (£000)

 

(4,809)

(4,477)

(8,242)

Weighted average number

 

 

 

 

of ordinary shares (000)

 

155,525

155,525

155,525

Loss per ordinary share

 

 

 

 

- basic and diluted

 

(3p)

(3p)

(5p)

 

 

______________

______________

______________

 

 

 

 

 

 

The loss per share is based on the weighted average number of ordinary shares in issue during the year. The Group has recorded a loss in all periods. No adjustment has been made to the basic loss per share, as the exercise of the share options would have the effect of reducing the loss per ordinary share and is anti-dilutive.

 

4. Share options

 

The Group has granted share options to eligible employees since 2003.

A summary of the movement on the Group's share option plans is:

 

 

30 June 2009

 

31 December 2008

 

 

 

 

 

 

 

Number of Shares

Weighted Average Exercise Price

 

Number of Shares

Weighted Average Exercise Price

 

__________

__________

 

__________

__________

 

 

 

 

 

 

Start of period

13,312,500

£0.69

 

11,782,500

£0.76

Granted

8,148,750

£0.09

 

2,555,000

£0.37

Forfeited

(10,950,000)

£0.69

 

(1,025,000)

£0.81

Exercised

-

-

 

-

-

 

__________

__________

 

__________

__________

At period end

10,511,250

£0.22

 

13,312,500

£0.69

 

__________

__________

 

__________

__________

 

 

 

 

 

 

Exercisable at period end

1,942,500

£0.70

 

4,504,166

£0.81

 

__________

__________

 

__________

__________

 

 

 

 

 

 

 

NOTES TO INTERIM FINANCIAL STATEMENTS

 

The following data are a summary of the status of the share options outstanding at 30 June 2009:

 

 

 

 

Remaining contractual life

Share Option Plan

Number

(years)

________________

_______________

_______________

 

 

 

A

119,000

4.0

B

196,000

5.3

C

218,333

6.0

D

150,000

7.0

E

1,252,500

7.7

F

50,000

7.9

G

241,667

8.4

H

-

8.9

I

135,000

9.5

J

7,848,750

9.9

K

300,000

9.9

________________

_______________

_______________

 

 

 

 

10,511,250

 

 

____________

 

 

 

 

 

On 14 May 2009 the Group offered employees the opportunity to forfeit their existing share option plans and, in their place, received 50% of the number of forfeited options in a new share option plan J. The options in the new plan have an exercise price of 8.5p and one sixth of the options vest every six months for three years. Under IFRS 2, the cancellation of existing options and the issue of replacement options are accounted for as modifications of the original options. 4,816,250 options were issued in plan J as replacements for cancelled options and a further 3,032,500 new options were issued.

 

The grant date fair value of plan J was £875,000, of which £35,000 related to the modification charge. The expense relating to the modification will be expensed over three years; the expense relating to the cancelled options will be expensed over the period of the original plans.

 

On 20 May 2009 the Group created a new share option plan K. 300,000 options were issued at an exercise price of 10p. Options under this plan, vest in equal one thirds on 30 June, 30 September, and 31 December 2009.

 

The grant date fair value of plan K was £20,000, which will be recognised in the period from 20 May 2009 to 31 December 2009.

 

Options are fair valued using the Black-Scholes option pricing model. No performance conditions were included in the fair value calculations. The following weighted average assumptions were used to estimate the fair value of stock options granted in the period:

 

Dividend yield

 

Nil

Expected volatility

 

105%

Risk free rates

 

3.89 %

Expected term

 

6.75 years

Expected volatility is based on historical volatility over the last three years of MGT Capital Investments, Inc (the parent company). The expected life is the average expected period to exercise. The risk free rate of return is the yield on zero-coupon UK government bonds of a term consistent with the assumed option life.

 

NOTES TO INTERIM FINANCIAL STATEMENTS

 

In the period ending 30 June 2009 the Group recorded a share option charge of £359,000 (30 June 2008: £617,000).

 

5. Related Parties

 

The Group has related party relationships with its subsidiaries, its parent company (MGT Capital Investments, Inc.), directors, employees and subsidiary companies of its parent Group.

Other subsidiary companies of the parent also operate from 66 Hammersmith Road, London and some establishment, finance, IT and administration costs are charged to, and from, these companies. In the six months to 30 June 2009 Beijing Medicexchange China Co. Limited and MGT Capital Investments (UK) Limited charged the Group £152,000 and £384,000 respectively. In this period the Group charged MGT Capital Investments (UK) Limited £13,000.

 

 

6. Reconciliation of net cash flows from operating activities

 

 

 

6 months ended

30 June 2009

6 months ended

30 June 2008

Year ended

31 December 2008

 

 

(unaudited)

(unaudited)

(audited)

 

 

£000

£000

£000

 

 

__________

__________

__________

 

 

 

 

 

Loss for the period

 

(4,809)

(4,477)

(8,242)

Adjustments for:

 

 

 

 

Depreciation

 

71

64

143

Loss on sale of investments

 

-

-

8

Interest income

 

(37)

(371)

(2,672)

Interest expense

 

-

-

-

Foreign currency finance cost

 

-

-

(148)

Share options

 

359

617

1,253

Changes in working capital

 

 

 

 

Trade and other receivables

 

408

(326)

(591)

Trade and other payables

 

(692)

336

812

 

 

__________

__________

__________

Cash used in operations

 

(4,700)

(4,157)

(9,437)

 

 

__________

__________

__________