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Basel, Switzerland, Mar 7, 2008 - (ABN Newswire) - First year of recurring revenues from SPP100 Lower than expected cash-burn
Basel/Switzerland and Bridgewater NJ/USA, 7 March 2008
Speedel Holding Ltd (SWX: SPPN) today announced consolidated financial results for the year ending 31 December 2007.
Financial Highlights 2007
* CHF 3.1 million recognised as revenues from sales of SPP100 (Tekturna/Rasilez[1]) by Novartis * CHF 55.5 million gross proceeds realised from a convertible bond transaction in January 2007 * Cash-burn of CHF 71.0 million * Solid cash reserves of CHF 107.9 million at year-end 2007
Konrad P. Wirz, Chief Financial Officer, commented: "We are pleased that the reported revenues of CHF 3.1 million reflect both stronger sales of SPP100 in Q4 2007 and an increasing contribution from a portion of the cost-of-goods savings achieved by Novartis using our production method for SPP100. The cash-burn of CHF 71.0 million, down from CHF 75.1 million in 2006, reflects the company's portfolio focus as well as our continuing strict cost control. Our solid financial reserves together with expected revenues from SPP100 sales will secure the funding of operations until approximately the end of 2009."
Alice Huxley, CEO, stated: "2007 was marked by successful further progress of our renin inhibitor programme with compounds from two series, SPP600 and SPP1100, in clinical phases I and II. The development of various compounds of this product family continuously expands our knowledge of renin inhibition. SPP301 is in the planning phase for a new Phase IIb dose finding study. In addition, we continued development on a new mode of action for the treatment of cardiovascular disease about which we will inform the investment community together with further updates on our clinical research programmes at Speedel's upcoming R&D day 31 March 2008."
Footnotes: [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: Q4 2007 = 7,794,160; Q4 2006 = 7,653,543 ; 12m 2007= 7,717,999; 12m 2006 = 6,860,926 [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 or loss
Consolidation is based on IFRS, but these results for the period are audited. Complete financial statements and notes for the 12 months ending 31 December 2007 can be accessed at http://www.speedel.com/section/6/subsections/4
Revenues SPP100 (Tekturna/Rasilez[1]) was approved by the FDA in March 2007 and by the EMEA in August 2007 and subsequently launched by Novartis in the US and Europe respectively. In January 2008, Novartis publicly reported total sales of USD 40 million for 2007 with USD 20 million in Q4.
The reported revenues of CHF 3.1 million for the year 2007 relate to royalties paid by Novartis on worldwide sales of SPP100 and payments equivalent to a portion of the savings resulting from a reduction in the cost-of-goods below a predetermined threshold, using the production method developed by Speedel for the commercial supply of SPP100.
Research & Development Expenses R&D expenses for the whole year decreased by CHF 13.4 million over 2006.This primarily reflects the reduced costs of our halted SPP301 programme in 2007 compared to the full year 2006, although we continued to incur closure costs for SPP301 in each quarter of 2007. The high variance of CHF 12.4 million for Q4, 2007 (CHF 15.7 million as opposed to CHF 28.3 million for Q4, 2006) is explained by high accrued expenses that had to be set up in conjunction with the halted ASCEND Phase III study of SPP301 in December 2006. Above all we continued to invest in our next generation renin inhibitor programmes both in clinical development (SPP635 in Phase IIa, SPP1148 Phase I, SPP676 Phase I) and in research (SPP1100 series, SPP800 series, SPP600 series).
General & Administration Expenses G&A expenses of CHF 12.0 million for the year under review were equivalent to those incurred in 2006. Increased communications activities and the associated higher costs were offset by cost savings in other areas.
Finance Costs, net Net finance costs 2007 of -1.3 million decreased substantially compared to finance costs of -6.3 million in 2006. The positive variance of CHF 5.0 million mainly reflects lower non-cash effective amortisation costs related to the CHF 55.5 million convertible bond issued in January 2007 compared to those of the CHF 70.0 million convertible loan issued in 2005. The company also benefited from the increased funds available for investment and improved money market interest rates, where most of our liquid assets were invested.
Balance Sheet In January 2007 the company issued a 3.5% p.a. convertible bond with a nominal value of CHF 55.5 million which is listed on the SWX Swiss Exchange under the symbol SPP07. The bond matures four years from the date of issue and can be converted at any time into voting shares at a fixed conversion rate of CHF 226 per share.
Share Capital On 31 December 2007, Speedel Holding Ltd had 7,800,560 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 520,035 shares with a nominal value of CHF 2 per share, mainly to cover the 2007 convertible bond and the company's employee share option plan.
Cash-burn Historically the company has provided guidance on cash-burn excluding any revenues from sources such as sales of SPP100 or other licensing agreements. It will continue to use this definition to ensure like-for-like comparisons with previous years when it had no recurring revenues.
The cash-burn for 2007 was 71.0 million and CHF 12.9 million for Q4 respectively. The company's previous guidance for full year 2007 cash-burn was approx. CHF 75 million. The lower cash-burn for 2007 compared to 2006 is partially driven by the fact that major costs for the new SPP301 Phase II programme in diabetic kidney disease will not be incurred until 2008.
Clinical Highlights 2007
* SPP100: FDA, EMEA and Swiss marketing approval, with launch by Novartis in the US and EU. * Next generation renin inhibitors: clinical trials of SPP1148, SPP635, SPP676 * SPP301: Phase III ASCEND analysis and decision to design new Phase IIb dose finding study
Financial Calendar 2008
Full year 2007 07 March 08 Annual Report 25 March 08 R&D Day 31 March 08 AGM 15 April 08 Q1 2008 15 May 08 Q2 2008 19 August 08 Q3 2008 14 November 08
Slides for the web cast will be downloadable from 13:00 CET today and the webcast will be accessible on the company's website until 7 April 2008. A podcast will also be available.
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 (Tekturna/Rasilez[1] ), the first-in-class direct renin inhibitor, was in-licensed from Novartis in 1999 and licensed-back to Novartis Pharma in 2002 for further development and commercialisation; SPP100 was approved by the FDA in the US in March 2007, and by the EMEA in the EU in August 2007. Our pipeline covers three different modes of action, and in addition to SPP100, includes SPP301 in Phase II, SPP200 in Phase II, SPP635 in Phase Il, SPP1148 and SPP676 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 January 2007 the company raised gross proceeds of CHF 55.5 million (approximately EUR 34.3 million or USD 44.5 million) through a convertible bond issue. 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. Previously, as a private company, we raised gross proceeds of CHF 255 million (approximately EUR 157 million or USD 204 million) from private placements of equity securities and two convertible loans including the conversion premiums. 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 in September 2005 on the SWX Swiss Exchange under the symbol SPPN.
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 word "may" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We 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.
-Ends-
[1] Tekturna/ Rasilez ® are Novartis trademarks
For further information please contact
Konrad P. Wirz CFO. Communications & Investor Relations ad interim Speedel Hirschgässlein 11 CH - 4051 Basel Switzerland
T +41 (0) 61 206 40 00 D +41 (0) 61 206 40 40 F +41 (0) 61 206 40 01 M +41 (0) 79 760 25 44 E konrad.wirz@speedel.com www.speedel.com
Frank LaSaracina Managing Director Speedel Pharmaceuticals Inc 1661 Route 22 West P.O. Box 6532 Bridgewater, NJ 08807 United States of America
T +1 732 537 2290 F +1 732 537 2292 M +1 908 338 0501 E frank.lasaracina@speedel.com www.speedel.com
