BASEL, Switzerland and BRIDGEWATER, N.J., March 8 /PRNewswire/ -- Speedel announced today financial results for the year ending 31 December 2005.
Financial Highlights * During the year the company raised gross proceeds of CHF 47.9 million in a private equity financing round, and CHF 70.0 million in a private convertible loan financing round * At 31 December 2005 liquid assets on hand were CHF 101.1 million * Cash-burn for 2005 was CHF 59.5 million compared with CHF 34.4 million for 2004, mainly reflecting the start of the Phase III clinical programme for SPP301 * On 08 September 2005 the company listed its registered shares on the SWX Swiss Exchange under the symbol SPPN, without issuing new shares or raising new funds
Konrad P. Wirz, Chief Financial Officer, commented: “We believe that 2005 was a decisive financial year for Speedel. We raised CHF 117.9 million in the two last private financing rounds before becoming a public company in September 2005. The cash-burn for 2006 is expected to increase to approximately CHF 80 million as we continue to invest in our mature and diverse pipeline.”
Excellent clinical newsflow in 2005 * In July the company started a Phase III pivotal morbidity and mortality trial for SPP301, a once daily oral endothelin A receptor antagonist, in the indication of diabetic kidney disease. Phase IIb data in this indication was presented at the American Society of Nephrology meeting on 11 November 2005 * In September Phase III data for SPP100 (Rasilez(1)), expected to be the first-in-class oral renin inhibitor, was presented by Novartis. This demonstrated strong efficacy and an excellent safety profile as monotherapy and co-administration therapy for the treatment of hypertension * In October the company started Phase I safety and tolerability testing of SPP635, one of a new series of renin inhibitors for the treatment of hypertension and protection of end-organs
Dr. Alice Huxley, Chief Executive Officer, said: “This was a tremendous year of achievement for Speedel as we delivered on all our milestones and stepped onto the public stage as one of Europe’s leading biopharmaceutical companies. 2006 is set to be just as exciting with Novartis expecting to file SPP100 in the US and Europe, and with important clinical newsflow on SPP200 and our next generation renin inhibitors.”
Financial Key Data (a) (CHF million) FY 2005 FY 2004 Change Q4 2005 Q4 2004 Change Revenues 0.0 0.0 - 0.0 0.0 - Research & Development (52.9) (28.1) +24.8 (11.3) (5.2) +6.1 General & Administration (11.0) (5.3) +5.7 (2.9) (1.8) +1.1 Total operating expenses (63.8) (33.4) +30.4 (14.2) (7.0) +7.2 Operating loss (63.8) (33.4) +30.4 (14.2) (7.0) +7.2 Finance costs, net (2.4) (4.4) -2.1 (1.4) (1.0) +0.4 Taxes 0.8 0.2 -0.5 0.1 0.0 -0.1 Loss for the period (65.4) (37.6) +27.8 (15.5) (8.0) +7.5 Basic & diluted loss per share/CHF (b) (11.48) (8.86) +2.62 (2.42) (1.87) +0.55 Cash-burn (c) 59.5 34.4 +25.1 13.9 7.5 +6.4 31 Dec 05 31 Dec 04 Change Liquid assets (d) 101.1 42.3 +58.8 (a) Numbers may not add up due to rounding (b) Earnings per share are calculated on the weighted average of registered shares outstanding for the periods: FY 2005 = 5,698,709; FY 2004 = 4,243,170; Q4 2005 = 6,414,271; Q4 2004 = 4,287,485 (c) 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 (d) Includes cash and cash equivalents and financial assets at fair value through profit and loss
Consolidation is based on IFRS, and the full year results are audited. Complete financial statements and notes for the 12 months ending 31 December 2005 can be accessed at http://www.speedel.com/section/6/subsections/3
Research & Development Expenses
R&D expenses increased by CHF 24.8 million for the full year and by CHF 6.1 million for the fourth quarter, compared to the corresponding periods in 2004. This increase primarily reflects entering Phase III with SPP301 and further expanded activities of our in-house research unit Speedel Experimenta.
General & Administration Expenses
G&A expenses increased by CHF 5.7 million for the full year and by CHF 1.1 million for the fourth quarter. The full year increase was partially due to non-recurring expenses associated with the listing of the Company on the SWX Swiss Exchange, as well as increased investor relations activities and the hiring of additional staff to support its new status as a public company.
Finance Costs, net
Net finance costs decreased by CHF 2.1 million over the previous year, principally due to reduced interest expense after a convertible loan of CHF 53.0 million was fully converted into shares in March 2005 before maturity, as well as more favourable money market interest rates. Subsequently, in August 2005 the company issued another convertible loan of CHF 70.0 million with a coupon of 2% per annum.
Balance Sheet
During the course of the year, the company raised gross proceeds of CHF 117.9 million in financing. In February 2005, the company raised CHF 47.9 million through the issuance of new shares in a private equity financing round. In March 2005, an existing convertible loan of CHF 53.0 million was fully converted into shares. In August 2005, the company received gross proceeds of CHF 70.0 million from the issuance of another convertible loan to its private shareholders. As of 31 December 2005, liquid assets on hand were CHF 101.1 million.
Share Capital
On 31 December 2005, Speedel Holding Ltd had 6,939,505 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 1,381,090 shares with a nominal value of CHF 2 per share, mainly to cover a convertible loan and the company’s share option plan.
Webcast and Conference Call
At 14.00 CET /13:00 London/ 08:00 EST today 08 March 2006, the company will host a webcast 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) 1 800 9464 UK: +44 (0) 208 974 7900 USA: +1 718 354 1175 International +44 (0) 208 974 7900 Passcode for all: C 332206
Slides for the webcast will be downloadable from 10:00 CET today and the webcast will be accessible on the company’s website until 07 April 2006
Briefing for media
A briefing for media will be held to provide a company update on its 2005 financial results:
Wednesday 08 September Zurich 10:45 - 12:00 CET Marriott Hotel Neumuhlequai 42 CH-8001 Zurich +41 (0) 44 360 70 70 RSVP: Astrid Lambert, Suter Global Communications, Zurich alambert@s-g-c.com +41 (0) 44 316 60 80 +41 (0) 76 332 1311 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(2)), the first-in- class renin inhibitor, is partnered with Novartis for Phase III development and commercialisation in hypertension with filing for registration expected in 2006. 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. Since being founded in 1998, we have 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 (2) Rasilez (SPP100, aliskiren) is a Novartis trade name pending regulatory approval
Speedel Pharmaceuticals, Inc.
CONTACT: Nick Miles, Director Communications & Investor Relations ofSpeedel, T +41-61-206-40-00, D +41-61-206-40-14, F +41-61-206-40-01, M+41-79-446-25-21, 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
