Vernalis plc: Preliminary Results for the Eight Months Ended 31 December 2003 LONDON, March 30 /PRNewswire-FirstCall/ -- Vernalis plc today announces its preliminary results for the eight months ended 31 December 2003 and the reacquisition of rights for frovatriptan in North America from Elan (see separate release). Highlights Frovatriptan -- Vernalis agrees to reacquire rights to frovatriptan in North America for $50 million, payable in installments up to 31 December 2005 (see today's separate release) -- Q4 2003 sales for frovatriptan of $13.7 million in North America -- Initiation of a second Phase IIIb study with frovatriptan for short-term prophylaxis of menstrually-associated migraine Pipeline products and research -- Announced today: -- Positive data from Phase II clinical study of V10153 in acute myocardial infarction patients and plans for a follow-up study in stroke. The product showed similar efficacy to marketed thrombolytic therapies and with no spontaneous bleeds. -- Positive results from Phase I study of V2006 (Parkinson's disease). The product was safe and well tolerated, achieving potentially therapeutic concentrations at the lowest dose tested. It also displayed a prolonged half-life consistent with once-daily dosing. -- Successful initial Phase I studies with the novel analgesic V140. -- Roche selects development candidate to treat obesity from 5HT(2C) receptor agonist research programme, currently undergoing pre-clinical studies by Roche. -- New oncology research collaboration with Novartis Institutes for BioMedical Research Inc. agreed in December 2003. -- Integration of British Biotech, RiboTargets and Vernalis Group completed in Q1 2004. Financial -- Revenue: 8.6 million pounds sterling (year ended April 2003 9.1 million pounds) -- Total operating loss: 29.4 million pounds (year ended April 2003 36.2 million pounds). Operatingloss before acquisitions: 17.3 million pounds -- Cash and short term investments of 24.2 million pounds at 31 December 2003 -- Restructuring to achieve full-year cost savings of 12.9 million pounds completed; additional savings realised from further post-merger restructuring which will reduce headcount to 110 during H1 2004. Commenting on the results, Vernalis' Chief Executive Officer Simon Sturge said: "In 2003 we embarked on a strategy of using M&A to create a sustainable, R&D-driven biotechnology company. Restructuring and rationalisation of the company's resources is now complete, and we have substantially reduced our cost base. The outlook for the company is also greatly enhanced by the reacquisition of the North American rights for frovatriptan and the positive results obtained in our clinical studies with V10153 and V2006. Our strategy in the year ahead is to continue to build Vernalis through the progression of our products and research and through participationin further M&A in the biotech sector." Enquiries: Vernalis plc Simon Sturge, Chief Executive Officer Tony Weir, Chief Financial Officer +44 (0) 118 977 3133 Brunswick Group (for analyst, financial media enquiries) Jon Coles; Wendel Carson +44 (0) 20 7404 5959 This document is not an offer of securities for sale in the United States of America. Securities may not be offered or sold in the United States of America absent registration or an exemption from registration. Safe Harbour statement: this news release may contain forward-looking statements that reflect the Company's current expectations regarding future events, including the clinical development and regulatory clearance of the Company's products, including thatof frovatriptan for menstrually-associated migraine, the Company's ability to find partners for the development and commercialisation of its products, including a new commercialisation partner (or partners) for frovatriptan, as well as the terms of such partnership(s), the projected benefits of reacquiring the rights to frovatriptan in North America and/or any new partnership arrangement(s) on the Company's liquidity and results of operations, as well as the Company's working capital requirements andfuture capital raising activities. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the success of the Company's research strategies, the applicability of the discoveries made therein, and the successful and timely completion of clinical studies, including with respect to frovatriptan and the Company's other products, the uncertainties related to the regulatory process, the ability of the Company to identify and agree beneficial terms with suitable partners for the commercialisation and/or development of frovatriptan and other products, as well as the achievement of expected synergies from such transactions, the acceptance of frovatriptan and other products by consumers and medical professionals, the ability of the Company to obtain additional financing for its operations and the market conditions affecting the availability and terms of such financing, the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions and the risks described in our mostrecent annual report on Form 20-F filed with the U.S. Securities and Exchange Commission (File No 0-20104). 1. Review of R&D operations (i) Product Portfolio Frovatriptan -- Prescription data Frovatriptan was launched in the US in the second quarter of 2002, where it is marketed as Frova(TM) by Elan Corporation and UCB as an acute treatment for migraine. Measured by prescriptions, Frova's annualised average share of the US oral triptan migraine market in 2003 was 2.7 per cent, with a market share in December 2003 of 3.1 per cent. Sales in the fourth quarter 2003 were $13.7 million, which resulted in sales for the eight months ended 31 December 2003 of $25.0 million. In Europe, frovatriptan is marketed by Menarini and has been launched in Germany, Austria, Eire and the UK. In Germany, where frovatriptan is marketed as Allegro(R), the drug's share of the overall triptan market at the end of 2003 was seven per cent. In January 2004 frovatriptan received marketing approval in Switzerland and pricing approval in Italy. Further European launches are expected during 2004. -- Achieving a distinct label for prophylaxis of menstrually-associated migraine In April 2003 data were presented from an initial clinical study into the efficacy of frovatriptan as a preventive treatment for menstrually associated migraine, which affects around 50 per cent of all women who suffer migraine. The data demonstrated a statistically highly significant improvement in the numbers of patients who were headache-free during the peri-menstrual period for both the studied dose regimens of frovatriptan compared to placebo (p