BASEL, Switzerland and BRIDGEWATER N.J., May 10 /PRNewswire-FirstCall/ -- Speedel today announced financial results for the three months ending 31 March 2006.
Financial Highlights * During the period the company raised gross proceeds of CHF 83.95 million through a public offering of 500,000 registered treasury shares * At 31 March 2006 liquid assets on hand were CHF 165.8 million * Cash-burn for the first quarter 2006 was CHF 16.8 million compared with CHF 15.7 million for the first quarter 2005, mainly reflecting the Phase III clinical programme for SPP301
Konrad P. Wirz, Chief Financial Officer, commented: "We are delighted with the success of our first public offering as a listed company, which has broadened the shareholder base and substantially increased liquidity. Our cash-burn rate of CHF 16.8 million for the first quarter is in line with our expectations of about CHF 80 million for the full year as we continue to invest in our mature and diverse pipeline."
Financial Key Data(i) (CHF million) Q1 2006 Q1 2005 Change Revenues 0.0 0.0 -- Research & Development (14.1) (14.8) -0.7 General & Administration (3.0) (1.8) +1.2 Total operating expenses (17.1) (16.6) +0.5 Operating loss (17.1) (16.6) +0.5 Finance costs, net (0.9) (0.7) +0.2 Taxes 0.1 0.6 +0.5 Loss for the period (17.9) (16.8) +1.1 Basic & diluted loss per share/CHF(ii) (2.78) (3.62) -0.84 Cash-burn(iii) 16.8 15.7 +1.1 31 Mar 06 31 Dec 05 Change Liquid assets(iv) 165.8 101.1 +64.7 Footnotes i-iv can be found on last page of this press release.
Consolidation is based on IFRS, but these results for the period are unaudited. Complete financial statements and notes for the 3 months ending 31 March 2006 can be accessed at http://www.speedel.com/section/6/subsections/3
Research & Development Expenses
R&D expenses decreased by CHF 0.7 million for the quarter compared to the corresponding period in 2005. This difference is due to two main factors which partially offset each other: during Q1 2005 there was a CHF4.0 million licence fee payment to a licensor upon reaching a development milestone, whereas during Q1 2006 there was an increase in ongoing R&D costs, mainly for the development programme of SPP301 which only entered Phase III in the second half of 2005.
General & Administration Expenses
G&A expenses increased by CHF 1.2 million for the quarter compared to the corresponding period in 2005, mainly due to the expensing of new share options granted to staff and to increased investor relations activities.
Finance Costs, net
Net finance costs increased by CHF 0.2 million for the quarter compared to the corresponding period in 2005. This difference reflects two main factors which largely offset each other: the increased debt servicing costs during Q1 2006 of the CHF 70.0 million convertible loan compared to the servicing costs for the CHF 53.0 million convertible loan during January and February 2005 before it was converted in March 2005; and the better returns on the company's liquid assets during Q1 2006 due to more favourable market conditions.
Balance Sheet
On 23 March 2006 the company concluded a successful public offering of 500,000 existing treasury shares. The final price was CHF167.90 per share, representing a discount of 0.65% to the closing price of CHF 169.00 on 07 March before the announcement of the offering. Gross proceeds were CHF 83.95 million. The total number of registered Speedel shares remained unchanged at approximately 6.96 million as no new shares were issued in connection with this offering. As of 31 March 2006, liquid assets on hand were CHF 165.8 million compared to CHF 101.1 million at 31 December 2005.
Share Capital
On 31 March 2006, Speedel Holding Ltd had 6,956,435 registered shares with a nominal value of CHF 2 per share which are listed on the SWX Swiss Exchange under the symbol SPPN. In addition the company had outstanding conditional share capital of 1,364,160 shares with a nominal value of CHF 2 per share, mainly to cover a convertible loan and the company's share option plan.
Key news flow on SPP100 (Rasilez(1)) * In January Novartis released positive top-line Phase III clinical results on SPP100 (Rasilez) in hypertension as long-term monotherapy and in co-administration with amlodipine (calcium channel blocker) and ramipril (ACE inhibitor). * In April Novartis confirmed that the U.S. Food and Drug Administration (FDA) have accepted for review the new drug application (NDA) for SPP100 as a treatment for hypertension both as monotherapy and in co- administration with other anti-hypertensives. The NDA includes data from more than 6,000 patients with high blood pressure treated with SPP100 in 34 clinical trials. * During the Annual Scientific Meeting and Exposition of the American Society of Hypertension (ASH), to be held in New York 16-20 May, further data on SPP100 (Rasilez) will be presented. This will be detailed Phase III data from trials conducted by Novartis on its use as a monotherapy and in co-administration with HCTZ (diuretic). Web cast and Conference Call
At 17.00 CET /16:00 London/ 11:00 EDT today 10 May 2006, the company will host a web cast which can be accessed at http://www.speedel.com/section/6/subsections/7. In addition participants may join a teleconference facility using the following telephone numbers:
Switzerland: +41 (0) 44 800 9464 UK: +44 (0) 208 974 7900 USA: +1 718 354 1175 International: +44 (0) 208 974 7900 Passcode for all: C 013158
Slides for the web cast will be downloadable from 10:00 CET today and the web cast will be accessible on the company's website until 09 June 2006.
Calendar 2006 Q2 2006 16 August Q3 2006 15 November R&D Day 29 November About Speedel
Speedel is a public biopharmaceutical company that seeks to create value for patients, partners and investors by developing innovative therapies for cardiovascular and metabolic diseases. Speedel is a world leader in renin inhibition, a promising new approach with significant potential for treating cardiovascular diseases. Our lead compound SPP100 (Rasilez), the first-in- class renin inhibitor, is partnered with Novartis for development and commercialisation in hypertension, and the NDA was filed with the FDA in the US in Q12006. Our pipeline covers three different modes of action, and in addition to SPP100, includes SPP301 in Phase III, SPP200 in Phase II, SPP635 in Phase I, and several pre-clinical projects. Speedel develops novel product candidates through focused innovation and smart drug development from lead identification to the end of Phase II. We either partner with big pharma for Phase III and commercialisation in primary-care indications, or we may ourselves complete Phase III development in specialist indications. Candidate compounds for development and the company's intellectual property come from our late-stage research unit Speedel Experimenta and from in-licensing. Our team of approximately 70 employees, including over 30 experienced pharmaceutical scientists, is located at our headquarters and laboratories in Basel, Switzerland and at offices in New Jersey, USA and Tokyo, Japan. In March 2006 the company raised gross proceeds of CHF 83.95 million (approximately EUR 53m or USD 64m) through the public offering of 500,000 treasury shares. As a private company, we have previously raised gross proceeds of CHF 239 million (approximately EUR 154 million or USD 183 million) from private placements of equity securities and two convertible loans and we have had total revenues, principally from milestone payments, of CHF 57.7 million (approximately EUR 37 million or USD 44 million). The company's shares were listed on the SWX Swiss Exchange under the symbol SPPN on 08 September 2005.
Forward looking statements
This press release includes forward-looking statements that involve substantial risks and uncertainties. These forward-looking statements are based on our current expectations and projections about future events. All statements, other than statements of historical facts, regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "may," "expects" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We or our partners may not actually achieve the plans, intentions or expectations described in these forward-looking statements and you should not place undue reliance on them. There can be no assurance that actual results of our research and development activities and our results of operations will not differ materially from these expectations. Factors that could cause actual results to differ from expectations include, among others: our or our partners' ability to develop safe and efficacious products; our or our partners' ability to achieve positive results in clinical trials; our or our partners' ability to obtain marketing approval and market acceptance for our product candidates; our ability to enter into future collaboration and licensing agreements; the impact of competition and technological change; existing and future regulations affecting our business; changes in governmental oversight of pharmaceutical product development; the future scope of our patent coverage or that of third parties; the effects of any future litigation; general economic and business conditions, both internationally and within our industry, including exchange rate variations; and our future financing plans.
(1) Rasilez (SPP100, aliskiren) is a Novartis trade name pending regulatory approval (i) Numbers may not add up due to rounding (ii) Earnings per share are calculated on the weighted average of registered shares outstanding for the periods: Q1 2006 = 6,444,315; Q1 2005 = 4,625,501 (iii) Cash-burn is defined as the difference in liquid assets between the beginning and end of the period, minus any cash inflow during the period (iv) Includes cash and cash equivalents and financial assets at fair value through profit and loss
Speedel Pharmaceuticals IncCONTACT: Nick Miles, Director Communications & Investor Relations ofSpeedel, T +41-(0)61-206-4000, D +41-(0)610206-4014, F +41-(0)-61-206-4001,M +41-(0)79-446-2521, nick.miles@speedel.com; or Frank LaSaracina, ManagingDirector of Speedel Pharmaceuticals Inc, T +1-732-537-2290, F+1-732-537-2292, M +1-908-338-0501, frank.lasaracina@speedel.com
Web site: http://www.speedelpharma.com/
