Final Results

Fulcrum Pharma PLC 15 November 2001 For Immediate Release: 15 November 2001 Fulcrum Pharma PLC Preliminary Results for the Period Ended 31 August 2001 Fulcrum Pharma PLC (LSE: FUL), the independent drug development company, today announces its preliminary results for the period ended 31 August 2001. Highlights: * Turnover increased 234% to £6.0 million (2000: £1.8 million) * PBT and exceptional items improved to £546,000 (2000: £24,000) * Fulcrum Japan enters profit for first time - contributing 25% of internal contribution * EPS of 0.70p a ten fold increase on the figure of 0.07p for last year (adjusted diluted EPS of 0.42p) * Net cash balance of £2.0 million * European, US and Japanese client base expanded - now includes: Shire, Xenova and Pharmagene as well as blue chip global Pharma and premier Japanese Pharma companies * Drug Development Services continue to be applied to a wide range of therapeutic areas Commenting on the results, Professor Sir Charles George, Chairman of Fulcrum Pharma, said: 'With the advent of contracts of higher value and increasing duration Fulcrum is building revenue streams that enable the Board to view the future with confidence. Strategies are in place to penetrate the US market, further expand our client base in Europe and Japan as well as grow the number and length of contracts. 'The Board anticipates another successful year of contract wins and international expansion and looks forward to reporting on further developments during the course of 2002.' For further information, please contact : Fulcrum Pharma PLC Jon Court, Chief Executive 0870 710 7152 Neil Oughton, Business Development Director 0870 710 7155 Buchanan Communications 0207 466 5000 Nicola How / Louise Bolton Fulcrum Pharma PLC Preliminary Results for the Period Ended 31 August 2001 OVERVIEW Fulcrum has established itself during the year as a leading provider of Virtual Drug Development Services to clients in all sectors of the industry across the globe. Fulcrum's clients include blue chip global Pharma, premier Japanese companies plus companies emerging as rising stars. The Company's specialism in Japan has enabled significant growth of the business and Fulcrum has worked, or is working, for five of the top twenty Japanese Pharma companies. Further Fulcrum is now supporting a major UK company to achieve its business goals in Japan. Revenues from Fulcrum's Drug Development Services business have increased significantly during the last year from £1.8 to £6.0 million. RESULTS BEFORE EXCEPTIONAL ITEMS Fulcrum is pleased to report a Profit Before Tax and exceptional items of £ 546,000 for the year ended 31 August 2001, achieved on turnover of £6,026,000 (2000 Profit Before Tax £24,000, turnover £1,804,000). Earnings per share on this basis were 0.70p, a tenfold increase on the figure of 0.07p last year. The adjusted diluted earnings per share after the expected deferred consideration (see section below) are 0.42p. It is our intention to pay a dividend after the interim results in 2002. EXCEPTIONAL ITEM Deferred consideration: Fulcrum acquired the share capital of Fulcrum Pharma Developments Ltd (FPD Ltd) in March 2000 by means of a share for share exchange. Due to uncertainties regarding the valuation of FPD Ltd, it was agreed between the company and the vendors that additional shares would be issued by the company, by way of deferred consideration, the number of such shares depending on the profits of the company in the year ending 31 August 2001. Although the directors believe that the substance of this arrangement is deferred consideration they have received advice that the appropriate accounting treatment is to charge the profit and loss account with the fair value of the additional shares to be issued (£950,000). This accounting entry does not reduce the Group's net assets and is a non-cash transaction. In the view of the directors, this amount should be disregarded for the purposes of reviewing the underlying performance of the company. Fulcrum has taken the decision to propose amendments to the share exchange agreement in order to eliminate interpretation issues and clarify the basis of the treatment of the deferred consideration which has been applied in these accounts. Such amendments will include an alteration to the definition of ' Profit Before Tax' contained in the share exchange agreement under which the amount of deferred consideration is calculated. The non-Executive directors have consulted with the Company's Nominated Adviser, Seymour Pierce and consider that this course of action is fair and reasonable as far as the shareholders are concerned. The agreed changes to the share exchange agreement do not affect the outcome and original intent of the share exchange agreement, which was to provide deferred consideration to certain of the vendors of FPD Ltd, as summarised in the prospectus dated March 2000 which was prepared in connection with the Company's admission to the Alternative Investment Market. As a result of the proposed amendments to the share exchange agreement, the deferred shares will be issued based on the profit before tax and exceptional items set out in this report. Accordingly following completion of the changes to the share exchange agreement the directors expect to issue 31,666,667 new ordinary shares to certain of the vendors of FPD Ltd. OPERATING REVIEW Client Update: Fulcrum's active and continued business development activities have resulted in initial and successful penetration of the key sectors of the pharmaceutical outsourcing market. Clients were dispersed through the major Pharma markets where R&D spend and outsourcing of drug development services are concentrated. Statistics show that the industry spent $45 billion on R&D in 2000 when expenditure was split as follows: US (36%), EU (37%) and Japan (19%). For reasons of client confidentiality it is not possible to name the majority of Fulcrum's clients. However, in the past year revenues were distributed evenly between 3 client sectors: emerging / biotech companies, blue chip large and mid size pharmaceutical and biotechnology companies and Japanese Pharma. Over the past year there has been a significant expansion of Fulcrum's client base in Europe, US and Japan, with the Group having provided drug development services to over 20 companies in these areas. Significantly, Fulcrum has worked for 5 of the top twenty Japanese Pharma companies over the past year, as well as with 2 of the top ten global Pharma companies. In addition the Group received significant repeat business. In Fulcrum's local market repeat business was won with Xenova and new contracts established with Shire and Pharmagene. Drug Development Services: Fulcrum's Drug Development Services have been widely applied over the past 12 months. The reasons that a company in the healthcare arena would use Fulcrum's services are most commonly to take advantage of the speed with which a tailor made, dedicated Fulcrum team can progress a drug through the complex development and regulatory approval process. Fulcrum enables faster and more cost effective drug development than industry standards. This is at a time when the Pharma industry as a whole has not improved productivity (number of new drugs produced per year) or development timelines over the past decade (source: 12th Annual FT World Pharmaceutical Conference, November 2001). The breadth of therapeutic areas to which Fulcrum's drug development services have been applied on behalf of clients has demonstrated the flexibility of Fulcrum's virtual drug development business model. These have included the development of anti-cancer, anti-infective, anti-inflammatory, central nervous system and metabolic disease therapeutics. Projects that have been implemented for clients, based on Fulcrum's key services, include: - Design and planning of drug development programmes and plans; - Implementation and management of programmes and plans through tailor-made teams; - Assembly and assessment of product information and knowledge for registration and marketing. Projects have included entire drug development programmes encompassing preclinical, clinical, manufacturing, regulatory science and Quality Assurance; partial programmes (e.g. clinical trials only); integration of Japanese designs into Western drug development programmes; working with and appointing Scientific Advisory Boards as well as advising on regulatory strategies. Japan Office: Last year Fulcrum established a foothold in the Japanese Pharma market resulting in significant business and client opportunities for the Group. The Fulcrum Pharma Japan office is located in the centre of the 'Pharma district' in Tokyo. This enables the necessary level of client contact in a market where it is essential to understand the culture in addition to the business drivers. The Japanese office is also convenient for Osaka where there is another concentration of potential clients. During the past year Fulcrum Japan and the Group have provided services to 5 of the top twenty Japanese Pharma companies plus non-Japanese Pharmas who have declared an intent to become top ten players in this market by the year 2010. The staff in the Tokyo office are Japanese nationals who combine extensive global drug development expertise with local knowledge to provide high quality local drug development services to Japanese and European clients plus business development for the UK office. FINANCIAL REVIEW Profit before tax and exceptional items has improved to £546,000 compared to £ 24,000 in the previous financial year. Our Japanese operation has been included in our financial consolidation for the first time and significantly Fulcrum Japan provided 25% of the Group's internal contribution. In January 2001 Fulcrum raised £1,250,000 through a placing of 12.5 million shares for the purposes of strategic expansion. These funds have enabled the Company to pursue expansion opportunities, which remain on target for implementation before the end of the next financial year. The Company has established a healthy cash position with a net balance of £2.0 million to support its strategy for future growth. Further highly qualified employees have been added to the Operations Group to deepen drug development experience and complement existing capabilities. Active recruitment is continuing. To drive recruitment and incentivise existing employees, management has introduced a bonus scheme related to the Company's financial performance. This is in addition to the existing share option schemes. FUTURE STRATEGY Fulcrum has drawn up a strategy for future growth and expansion. The Group's key focus area will be on growing the number and duration of contracts by continuing its high quality service to existing customers as well as spending management time and resource on winning new clients through targeted business development. In 2002 it is also Fulcrum's aim to utilise its funds for strategic expansion to access portfolios of contracts from the Industry and to accelerate penetration of the world's largest healthcare market, the US, and it is likely that this will be achieved through the Group opening a US office during 2002 (although the Group is not able to discuss exact plans at this stage). The Board of Fulcrum also fully intends to increase its capabilities in the fast-growing Japanese outsourcing market - the last year has seen the Group expand in this area ahead of expectations and the Board sees no reason why this trend should not continue in the future. PROSPECTS With the advent of contracts of higher value and increasing duration Fulcrum is building revenue streams that enable the Board to view the future with confidence. Strategies are in place to penetrate the US market, further expand our client base in Europe and Japan and grow the number and duration of contracts. The Board anticipates another successful year of contract wins and international expansion and looks forward to reporting on further developments during the course of 2002. Professor Sir C F George Dr J P Court Chairman Chief Executive Officer 14 November 2001 Consolidated profit and loss account For the year ended 31 August 2001 28 weeks to 31 August 52 weeks to 31 August 2001 2000 Notes Before Exceptional Exceptional Items items (2) Total Total £'000 £'000 £'000 £'000 TURNOVER 1 6,026 - 6,026 1,804 Cost of Sales (4,642) (554) (5,196) (987) GROSS PROFIT 1,384 (554) 830 817 Selling expenses (201) (185) (386) (86) Administrative expenses (686) (211) (897) (720) OPERATING PROFIT/(LOSS) 2 497 (950) (453) 11 Interest receivable and similar 49 - 49 13 income PROFIT/(LOSS) ON ORDINARY ACTIVITIES BEFORE TAXATION 546 (950) (404) 24 Tax on profit/(loss) on ordinary activities (163) - (163) (7) RETAINED PROFIT/(LOSS) FOR 383 (950) (567) 17 THE PERIOD Earnings per share (pence) Adjusted basic 4 0.70p 0.07p Adjusted diluted 4 0.42p 0.07p Basic and diluted 4 (1.04p) 0.07p Adjusted earnings per share excludes the effect of the exceptional items. STATEMENT OF TOTAL RECOGNISED GAINS AND LOSSES There were no recognised gains and losses other than the loss for the year ended 31 August 2001 of £567,000 (2000: profit of £17,000). BALANCE SHEET At 31 August 2001 Group Company 2001 2000 2001 2000 Notes £'000 £'000 £'000 £'000 FIXED ASSETS Tangible assets 42 13 - - Investment in subsidiaries - - 133 133 CURRENT ASSETS Debtors 985 892 2,001 713 Cash at bank and in hand 1,980 716 58 18 2,965 1,608 2,059 731 CREDITORS: amounts falling due within one year (572) (849) (23) (10) NET CURRENT ASSETS 2,393 759 2,036 721 TOTAL ASSETS LESS CURRENT LIABILITIES 2,435 772 2,169 854 PROVISIONS FOR LIABILITIES AND CHARGES (10) - - - 2,425 772 2,169 854 CAPITAL AND RESERVES Called up share capital 5 615 467 615 467 Share premium 5 1,543 421 1,543 421 Merger reserve 5 (133) (133) - - Profit and loss account 5 400 17 11 (34) Equity shareholders' funds: 2,425 772 2,169 854 Jon Court Neil Oughton Director Director 15th November 2001 CONSOLIDATED STATEMENT OF CASH FLOW For the year ended 31 August 2001 52 weeks to 28 weeks to 31 August 31 August 2001 2000 Notes £'000 £'000 NET CASH INFLOW/(OUTFLOW) FROM OPERATING ACTIVITIES 6a 15 (29) RETURNS ON INVESTMENTS AND SERVICING OF FINANCE Interest received 49 13 TAXATION PAID (7) - CAPITAL EXPENDITURE AND FINANCIAL INVESTMENT Purchase of tangible fixed assets (63) (23) NET CASH OUTFLOW BEFORE MANAGEMENT OF LIQUID RESOURCES AND FINANCING (6) (39) FINANCING Issue of ordinary share capital 1,320 1,000 Share issue costs (50) (245) 1,270 755 INCREASE IN CASH 1,264 716 RECONCILIATION OF NET CASH FLOW TO MOVEMENT IN NET FUNDS 52 weeks to 28 weeks to 31 August 31 August 2001 2000 £'000 £'000 Increase in cash 1,264 716 NET FUNDS AT START OF YEAR 6b 716 - NET FUNDS AT END OF YEAR 6b 1,980 716 NOTES TO THE ACCOUNTS For the year ended 31 August 2001 1. SEGMENTAL INFORMATION The group has a single class of business of virtual drug development. Turnover by geographical market is given below: 52 weeks to 28 weeks to 31 August 31 August 2001 2000 £'000 £'000 United Kingdom 3,519 312 Rest of Europe 148 367 United States of America 1,527 824 Japan 832 301 6,026 1,804 2. EXCEPTIONAL ITEM As set out in the paragraph below, the Company has recorded an exceptional charge of £950,000 in the profit and loss account to reflect the difference between the fair value of the shares at the date of the agreement and the amount of consideration, if any, that shareholders may be required to pay for the additional shares. This charge has been allocated across the relevant cost centres to which the individuals provide their services as follows: £'000 Cost of sales 554 Selling Expenses 185 Administrative expenses 211 950 The Group has an operating profit before tax and exceptional items of £497,000 (2000: £11,000). As disclosed in the listing document dated 8 March 2000, produced by the Company in connection with its admission to the Alternative Investment Market ('AIM') and in the Company's annual accounts for the year ended 31 August 2000, certain shareholders, including directors, of the Company are entitled under a share exchange agreement dated 7 March 2000 to be allotted up to a maximum of 56,666,666 additional 1p ordinary shares in the Company by reference to the consolidated profits before tax of the Group for the twelve months ended 31 August 2001. Based on the profit before tax and exceptional items of £546,000, the Company expects to issue 31,666,667 additional ordinary shares as deferred consideration. 3. DIVIDENDS The Directors do not propose a dividend for the year ended 31 August 2001. 4. EARNINGS PER SHARE The basic earnings per ordinary share is based on the Group's loss for the year of £567,000 (2000: profit of £17,000) divided by the weighted average number of ordinary shares in issue, calculated using merger accounting principles, of 54,547,619 (2000: 24,423,559). Diluted earnings per share is the same as basic earnings per share as the effect of options and shares to be issued is anti-dilutive. Adjusted basic earnings per ordinary share is based on the Group's profit before exceptional items of £383,000, divided by the weighted average number of ordinary shares in issue, calculated using merger accounting principles, of 54,547,619. The adjusted diluted earnings per share is based on the Group's profit for the year before exceptional items of £383,000, and on 90,672,904 ordinary shares calculated as follows: 2001 Basic weighted average number of shares 54,547,619 Dilutive potential ordinary shares - employee share options 2,613,023 - shares to be issued under share exchange agreement 31,666,666 - warrants 1,845,596 90,672,904 5. RECONCILIATION OF MOVEMENTS ON RESERVES AND SHAREHOLDERS' FUNDS Called up Share Profit Share Premium Merger & loss Capital Account Reserve account Total £'000 £'000 £'000 £'000 £'000 At incorporation - - - - - Issue of share capital 467 666 - - 1,133 Admission costs - (245) - - (245) Profit for the period - - - 17 17 Equity elimination upon consolidation - - (133) - (133) At 1 September 2000 467 421 (133) 17 772 Issue of share capital 148 1,172 - - 1,320 Issue costs - (50) - - (50) Loss for the year - - - (567) (567) Discount on shares and share options - - - 950 950 At 31 August 2001 615 1,543 (133) 400 2,425 6. NOTES TO THE STATEMENT OF CASH FLOWS (a) Reconciliation of the operating (loss)profit to net cash inflow/ (outflow) from operating activities: 2001 2000 £'000 £'000 Operating loss (453) 11 Depreciation 34 10 Non cash exceptional item 950 - (Increase) in debtors (93) (892) (Decrease)/increase in creditors (423) 842 Net cash inflow/(outflow) from operating activities 15 (29) (b) Analysis of net funds At 1 September At 31 August 2000 Cash flow 2001 £'000 £'000 £'000 Cash at bank and in hand 716 1,264 1,980 7. ANNOUNCEMENT BASED ON DRAFT ACCOUNTS The financial information set out in the announcement does not constitute the Company's statutory accounts for the periods ended 31 August 2001 or 2000. The financial information for the year ended 31 August 2000 is derived from the statutory accounts for that period which have been delivered to the Registrar of Companies. The auditors reported on these accounts; their report was unqualified and did not contain a statement under s237(2) or (3) Companies Act 1985. The statutory accounts for the year ended 31 August 2001 will be finalised on the basis of the financial information presented by the directors in this preliminary announcement and will be delivered to the Registrar of Companies following the company's annual general meeting. Copies of the accounts are being sent to shareholders and are also available to the public at the registered office of the Company, Hamilton House, 111 Marlowes, Hemel Hempstead, Hertfordshire HP1 1BB.
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