Preliminary Results

Fulcrum Pharma PLC 09 November 2005 For immediate release 9 November 2005 FULCRUM PHARMA PLC ('the Group' or 'the Company') Preliminary Results for the Year Ended 31 August 2005 Fulcrum Pharma plc (AIM: FUL), the drug development and strategic outsourcing services company, today announces its preliminary results for the year ended 31 August 2005. Highlights > Profitable before exceptional items in second half > Loss before tax of £76,000 (loss of £1.2 million in 2004) > Strategy to improve performance taking effect > Business development reorganisation and new clients won > Group order book strengthening > FY 2005 operating costs (excluding exceptionals) reduced by more than £500,000 Commenting on the results, Chairman Prof. Sir Charles George said: 'I am pleased to see that the Group has continued to strengthen its order book and win new clients. Implementation of our sales and marketing reorganisation has had a positive impact on the business and, together with improved performance, a reduced cost base and strong balance sheet, Fulcrum will focus on taking the business to the next stage of its development. The Group plans to deepen its expertise in drug substance and formulation management and in preclinical and regulatory services and is seeking suitable opportunities to increase scale.' FOR FURTHER INFORMATION, PLEASE CONTACT: Fulcrum Pharma PLC Tel: 0870 710 7152 Jon Court, Chief Executive Buchanan Communications Tel: 020 7466 5000 Mark Court, Mary-Jane Johnson Fulcrum Pharma PLC Preliminary Results for the Year Ended 31 August 2005 Chairman's Report Business Review Since my report last year, the Group has taken considerable steps to improve its performance and to grow the core service business. These steps included the reorganisation of the sales and marketing function, the tailoring of business development and the continued effort to increase global sales to new clients. The tailored approach to business development has reduced the Group's reliance on networked sales and has strengthened the order book, which, together with effective cost management and the more efficient use of staff, has resulted in the return to profitability in the second half of the financial year. Fulcrum's turnover for the year was £12.6m (2004: £11.1m) and the loss before tax was £76,000 (2004: loss of £1.2 m). The pharmaceutical services sector is emerging from a number of challenging years and there are signs that the need for outsourcing is gaining momentum. Emerging pharma and biotechs continue to operate in a difficult funding environment and strategic outsourcing is proving to be an important way for them to improve capital efficiency. In particular there is growth in drug substance and formulation management and preclinical services, where Fulcrum has considerable expertise, and in regulatory services where new opportunities are arising. In addition, our global service model enables companies to operate outside of their domestic market. For example the orphan drug regulations in Europe allow US clients to create value and extend exclusivity in the market place. Additionally, large pharma clients in Japan continue to seek faster to market solutions by outsourcing development to the US and to Europe. Results The results for the year ended 31 August 2005 show a loss before exceptional items of £315,000 (2004: £862,000). Operating costs, excluding exceptional credits and charges, are £3.0m compared to £3.6m in 2004. Included in these costs is an exchange gain of £5,000 (2004: loss of £114,000). The exceptional credit of £239,000 represents the income from the surrender of the lease on the UK office less the costs associated with relocation to new premises. The agreement to surrender the lease was signed in March 2005. The exceptional charge in 2004 represents the costs of the subsidiary, Fulcrum Ventures Limited, which was set up to in-licence rights to mid-to-late oncology products and develop them. The retained loss for the year was £89,000 (2004: £1.4m) and the loss per share was 0.07p (2004: 0.93p). The Group's balance sheet remains strong overall with net cash at 31 August 2005 of £1.5m (2004: £2.2m). No interim dividend was paid (2004: 0.2p per share) and no second half dividend is recommended. Operating Review Business Development and Sales The reorganisation of sales and marketing on a regional basis has had a positive impact on sales. Fee sales increased in the second half of the year to £3.3m from £2.9m in the first half year. The Group has won a significant number of new clients in Europe. Market research conducted in the US was used to hone our service offerings to the biotech community. The knowledge gained was used to execute a targeted campaign to increase client awareness. This campaign included sponsorship of, and presentations at, major biotechnology and partnering conferences in the US, Europe and Japan such as ASCO, BECIF, Bio Asia and BioBusiness, and has resulted in a strengthening of the pipeline of contracts and prospects. Establishing long term business relationships A core of long term relationships has been established in Europe, which has contributed more than 60% of European sales in the current financial year. In May 2005 we announced a long term agreement with Syngenta Biopharma under which Fulcrum continues to provide drug development expertise and is embedding critical tools and processes from Fulcrum's 'Document Driven Drug Development' platform into the client organisation. In addition, Fulcrum's partnership with Addex Pharmaceuticals S.A. continues to support the delivery of Addex's portfolio of products to treat disease of the Central Nervous System. We were delighted that Addex were able to announce that ADX10059 had started clinical studies in France. This achievement of getting a drug from discovery into the clinic in less than 3 years is a strong validation of the executional capabilities of the partnership. Sales from Japan Our investment in business development in Japan continues to generate sales from Japan into Europe and the US. Japan has contributed 12% of fee sales in Europe and the US. Our Japanese clients include large pharma and emerging biotechs such as NanoCarriers Co., Ltd. These companies utilise our skillsets and resources in the European and US subsidiaries. Fulcrum has also won contracts from emerging European companies seeking the opportunity to create value in the Japanese market. Regional Performance Europe The sales pipeline and order book strengthened throughout the year. Encouragingly our business development team has won a significant number of new clients in the second half year and has delivered cross sales to the US office and Japan. Whilst sales in Europe have decreased by 10% over the previous year as a result of the weak order book at the start of the year, the performance in the second half has been good. Significant cost savings have been achieved in this financial year. This includes £230,000 of permanent annual savings, the majority of which relate to the reorganisation of sales and marketing and the remainder to the rent differential on relocation of the UK office. US The US subsidiary has continued to grow through its domestic customer base, from cross sales from Japan and from the provision of resources to the European subsidiary. The latter has allowed efficient use of global resources. Overall US fee sales have grown by circa 20% compared with the same period last year. Japan The Japanese Group has matured into a specialist oncology CRO and regulatory group to meet the needs of the local market. Japan had a slow start to the year but made a substantial recovery in the second half. Our specialist oncology CRO has gained significant orders for the next 2 years including a phase II study with a major US biotech (unnamed) which was won as a result of delivering a successful pilot project. Board changes The resignation of Dr Bruce McCreedy was announced in September 2005. To drive the Company's global service model further forward, it is intended to strengthen the Board during the coming year with more expertise from the service sector. Future Strategy Having returned to profitability in the second half, Fulcrum is continuing to deepen its expertise in key drug development areas and grow the business to the next stage. The cornerstones of the Group's strategy remain: 1. Grow the service business in 3 regions and develop the global service model 2. Increase scale - Regulatory, preclinical, drug substance and formulation 3. Add further value through - Long term relationships - Risk sharing Prospects & Outlook The pharma and biotech outsourcing market remains competitive. However, companies increasingly need to demonstrate efficient use of capital and improved productivity. These factors are driving drug developers towards outsourcing as a core strategy. With stronger order books over last year the Group looks to improve profitability further. Conclusion Fulcrum continues to concentrate on strengthening its order book and now intends to improve performance and focus on taking the business to the next stage of its development. With a reduced cost base and strong balance sheet, Fulcrum plans to deepen its expertise in drug substance and formulation management and in preclinical and regulatory services and is seeking suitable opportunities to increase scale. Consolidated Profit & Loss Account for the year ended 31 August 2005 Year Ended Year Ended 31 August 31 August 2005 2004 Unaudited Audited Note £'000 £'000 Turnover 2 12,626 11,085 Cost of sales (10,014) (8,434) Gross profit 2,612 2,651 Selling expenses (654) (810) Administrative expenses (2,320) (2,752) Exceptional administrative credit/(expenses) 3 239 (348) Total administrative expenses (2,081) (3,100) Operating loss (123) (1,259) Interest receivable and similar income 56 58 Interest payable and similar charges (9) (9) Loss on ordinary activities before taxation (76) (1,210) Tax on loss on ordinary activities 4 (13) 88 Loss on ordinary activities after taxation (89) (1,122) Dividends 5 - (244) Loss for the year transferred to reserves (89) (1,366) Loss per share (pence) 6 Basic and diluted (0.07p) (0.93p) Adjusted basic and diluted (0.23p) (0.69p) Statement of Total Group Recognised Gains and Losses for the year ended 31 August 2005 2005 2004 £'000 £'000 Unaudited Audited Loss on ordinary activities after taxation (89) (1,122) Exchange adjustments offset in reserves (8) (82) Adjustment in respect of employee share schemes (8) 16 Total recognised gains and losses since last annual report (105) (1,188) Consolidated Balance Sheet as at 31 August 2005 2005 2004 Unaudited Audited £'000 £'000 Fixed assets Tangible assets 460 584 Investments 172 85 632 669 Current assets Debtors 3,335 3,351 Short term investments 1,193 1,423 Cash at bank and in hand 678 1,045 5,206 5,819 Creditors: amounts falling due within one year (2,481) (2,831) Net current assets 2,725 2,988 Total assets less current liabilities 3,357 3,657 Creditors: amounts falling due after more than one year (31) (226) Net assets 3,326 3,431 Capital and reserves Called up share capital 1,219 1,219 Share premium account 4,370 4,370 Merger reserve (454) (454) Profit and loss account (1,809) (1,704) Equity shareholders' funds 3,326 3,431 Consolidated Cash Flow Statement for the year ended 31 August 2005 Note 2005 2004 £'000 £'000 Unaudited Audited Net cash outflow from operating activities 7 (492) (843) Returns on investment and servicing of finance Interest received 56 58 Interest paid (9) (9) Net cash inflow from returns on investments and servicing of 47 49 finance Taxation Corporation tax (paid)/received (3) 176 Capital expenditure and financial investment Purchase of own shares for employee share options and awards (29) (43) Purchase of equity investments (87) (85) Purchase of tangible fixed assets (69) (293) Net cash ouflow from capital expenditure and financial investment (185) (421) Dividends Equity dividends paid to shareholders 5 - (244) Net cash outflow before management of liquid resources and (633) (1,283) financing Management of liquid resources Decrease in short term investments 230 1,402 Financing New finance leases - 58 Increase in borrowings 100 152 Capital element of finance lease payments (37) (32) Bank loan repayments (26) (23) 37 155 (Decrease)/increase in cash 7 (366) 274 Reconciliation of net cash flow to movement in net funds Note 2005 2004 £'000 £'000 Unaudited Audited (Decrease)/increase in cash (366) 274 Increase in bank loans (74) (129) Decrease in short term investments (230) (1,402) Increase/(decrease) in finance leases 30 (26) Change in net funds from cash flows (640) (1,283) Net funds at 1 September 2,179 3,462 Net funds at 31 August 7 1,539 2,179 1 Financial Information The results for the year ended 31 August 2005 are unaudited and do not constitute statutory accounts within the meaning of section 240 of the Companies Act 1985. They have been drawn up using accounting policies and principles consistent with those applied in the preparation of the audited accounts for the year ended 31 August 2004. The comparative information contained in the report for the year ended 31 August 2004 does not constitute the statutory accounts for the financial period. Those accounts have been reported on by the Company's Auditors, PricewaterhouseCoopers LLP, and delivered to the Registrar of Companies. The report of the Auditors was unqualified and did not contain a statement under section 237(2) or (3) of the Companies Act. 2 Turnover Turnover represents sales to third parties including fee income and pass through costs. Geographical analysis by origin 2005 2004 £'000 £'000 Unaudited Audited Europe 3,082 3,414 USA 1,524 1,305 Japan 1,571 1,192 Total Fee Income 6,177 5,911 Pass through costs 6,449 5,174 Turnover 12,626 11,085 Geographical analysis by destination 2005 2004 £'000 £'000 Unaudited Audited United Kingdom 3,245 4,218 Rest of Europe 3,290 1,448 North America 3,380 2,904 Japan 2,698 2,515 Rest of the World 13 - Turnover 12,626 11,085 3 Exceptional items The Group has reported a loss before tax and exceptional items of £315,000 (2004: £862,000). The Group has recorded an exceptional credit to administrative expenses of £239,000 (2004: a charge of £348,000). The exceptional credit represents the income from the surrender of the lease on the UK office less the costs associated with the relocation to new premises. The agreement to surrender was signed in March 2005. The charge in 2004 represents the cost of the Group's enterprise, Fulcrum Ventures Limited, which was set up to in-licence rights to mid-to-late clinical stage oncology products and develop them. 2005 2004 £'000 £'000 Unaudited Audited Loss on ordinary activities before tax (76) (1,210) Exceptional administrative (credit)/expenses (239) 348 Loss on ordinary activities before taxation and exceptional items (315) (862) 4 Tax on loss on ordinary activities 2005 2004 £'000 £'000 Unaudited Audited UK taxation UK corporation tax at 30% - (63) Adjustment in respect of prior year - 18 - (45) 13 - Overseas taxation Corporation taxes Total current taxation 13 (45) Deferred taxation Origination and reversal of timing differences - (43) Tax on loss on ordinary activities 13 (88) No UK tax charge has arisen due to losses carried forward. The tax on the exceptional gain is set off against tax losses arising in the year. 5 Dividends No interim dividend was declared or paid during the year (2004: £244,000, representing 0.2p per share). The dividend was paid from the distributable reserves of Fulcrum Pharma plc. No final dividend has been proposed (2004: £nil). 6 Loss per share 2005 2004 Unaudited Audited Basic loss per share (0.07)p (0.93)p Adjustment for exceptional costs 0.16p 0.24p Adjusted loss per share (0.23)p (0.69)p 2005 2004 Profit before Exceptional Total Profit Exceptional Total exceptional items before items items exceptional items £'000 £'000 £'000 £'000 £'000 £'000 Unaudited Unaudited Unaudited Audited Audited Audited Loss before taxation (315) 239 (76) (862) (348) (1,210) Tax on loss 35 (48) (13) 25 63 88 Loss after taxation (280) 191 (89) (837) (285) (1,122) 2005 2004 Number Number Unaudited Audited Weighted average number of shares for basic and fully diluted EPS 121,185,914 121,151,541 The basic loss per ordinary share is based on the Group's loss for the year of £89,000 (2004: £1,122,000) divided by the weighted average number of ordinary shares in issue, excluding those shares held by the Employee Share Ownership Trust ('ESOT'). In 2005 and in 2004, the number of shares used in the calculation of diluted loss per share was the same as that used in the calculation of basic loss per share as the Group incurred a loss. Exceptional items within operating profit and exceptional tax charges or credits do not relate to the results of the Group on an ongoing basis. Therefore an adjusted loss per ordinary share is presented based on the Group's loss before exceptional items of £280,000 (2004: £837,000), divided by the weighted average number of ordinary shares in issue, excluding those shares held by the ESOT. 7 Notes to the consolidated cash flow statement Reconciliation of the operating loss to net cash outflow from operating activities: 2005 2004 £'000 £'000 Unaudited Audited Operating loss (123) (1,259) Depreciation 197 238 Disposal of shares in ESOT 20 59 Loss on disposal of fixed assets 1 - Exchange loss (7) (82) Decrease/(increase) in debtors 17 (549) (Decrease)/increase in creditors (597) 750 Net cash outflow from operating activities (492) (843) Analysis of net funds As at As at 1 September 31 August 2004 Cash flow 2005 £'000 £'000 £'000 Audited Unaudited Unaudited Cash at bank and in hand 1,045 (366) 679 Bank loan (196) (74) (270) Short term investment 1,423 (230) 1,193 Finance lease (93) 30 (63) 2,179 (640) 1,539 8 Copies of Annual Report Copies of the Annual Report are being sent to the shareholders and will be available to the public at the registered office of Fulcrum Pharma plc, 5th Floor, Kodak House, Station Road, Hemel Hempstead, Hertfordshire, HP1 1JY. This information is provided by RNS The company news service from the London Stock Exchange
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