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30th March 2004. Vernalis
plc (LSE: VER, Nasdaq: VNLS) 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 instalments 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: o
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. o
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. o
Successful
initial Phase I studies with the novel analgesic V140. ·
Roche
selects development candidate to treat obesity from 5HT2C 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 (year ended April 2003 £9.1 million) ·
Total
operating loss: £29.4 million (year ended April 2003 £36.2 million). Operating
loss before acquisitions: £17.3 million ·
Cash
and short term investments of £24.2 million at 31 December 2003 ·
Restructuring
to achieve full-year cost savings of £12.9 million 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 participation in further M&A in the biotech sector.”
Enquiries: Vernalis
plc
Simon
Sturge, Chief Executive Officer Tony
Weir, Chief Financial Officer Tel:
+44 (0)118 977 3133 Brunswick
Group (for analyst, financial media enquiries)
Jon
Coles; Wendel Carson Tel: +44 (0)20 7404 5959
Northbank Communications (for trade media enquiries)Peter Colley Tel: +44 (0)1260 296500 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 that of 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 and future 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 most recent annual report on Form 20-F filed with the U.S. Securities and Exchange Commission (File No 0-20104).
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