SPEEDEL announces financial results for first quarter 2008
Reduced net loss for the period
- CHF 2.2 million recognised as estimated revenues for Q1 2008 from sales of SPP100/Aliskiren (Tekturna/Rasilez®) by Novartis
- Reduced operating expenses: CHF 14.1 million in Q1 2008
- Liquid assets of CHF 94.5 million as of 31 March 2008
Konrad P. Wirz, Chief Financial Officer, commented: "We are pleased to note that SPP100/Aliskiren (Tekturna/Rasilez®) sales grew substantially over the last two quarters. Due to the U.S. Dollar exchange rates our corresponding revenues in CHF do not entirely reflect the increase of this positive sales development."
Accrued revenues reflect management's best estimate regarding royalty income on global net sales of SPP100/Aliskiren (Tekturna/Rasilez®) by Novartis and compensation from Novartis for reduced manufacturing costs of SPP100, using the chemical synthesis route developed by Speedel and licensed to Novartis in 2002. This Q1 estimate is subject to revision once Speedel has received the Q1 2008 royalty report from Novartis.
Research & Development Expenses
R&D expenses decreased by CHF 0.2 million for the first quarter 2008 compared to the corresponding period in 2007. Two factors partially offset each other: expenses for SPP301 decreased significantly, whereas investments in our next generation renin inhibitor programmes increased - both in clinical development (SPP635 in Phase IIa, SPP1148 Phase I, SPP676 Phase I) and in research.
General & Administration Expenses
G&A expenses decreased by CHF 0.7 million for the first quarter 2008 compared to the first quarter in 2007, mainly due to less non-cash expenses for new share options granted to staff.
Finance Costs, net
Net finance costs increased by CHF 0.9 million for the first quarter 2008 compared to the same period of 2007. This difference mainly mirrors exchange losses on U.S. Dollar positions and higher expenses for the convertible bond issued end of January 2007.
The reduced net loss for the period under review arises mainly from the increase in recognised revenues from SPP100/Aliskiren.
As of 31 March 2008, liquid assets were CHF 94.5 million compared to CHF 107.9 million at 31 December 2007. Together with the expected revenues from SPP100/Aliskiren sales, these funds provide a comfortable basis to finance the company's current pipeline until approximately the end of 2009.
On 31 March 2008, Speedel Holding Ltd. had 7,807,177 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 513,418 shares with a nominal value of CHF 2 per share to cover the convertible bond and the company's employee share option plan.
The cash-burn for the first quarter 2008 was 15.2 million. The company maintains the previous guidance for full year 2008 cash-burn of CHF 57-60 million.
Additional events in Q1 2008
- As announced on 21 January 2008, the U.S. Food and Drug Administration approved Tekturna® HCT, the single-tablet combination of two antihypertensive drugs - SPP100/Aliskiren (Tekturna/Rasilez®) and the diuretic hydrochlorothiazide (HCT). About one third of antihypertensive prescriptions in the U.S. are written for HCT, either as combination or as monotherapy. Therefore, the approval was an important step forward for the acceptance of Aliskiren in the market.
- On 31 March 2008 Speedel held an R&D Day. The data provided support the company's mature and diverse pipeline, targeting therapeutic areas with significant unmet medical need and high commercial potential. Remaining the world leader in renin inhibition is a strategic objective for Speedel. Besides two further modes of action in cardiovascular medicine covered by the pipeline, the company presented for the first time data on a new mode of action that has the potential to reduce the production of aldosterone, another important player in cardiovascular and metabolic diseases.
Webcast and Conference Call
At 15:00 CET / 14:00 UK time / 09:00 EST today, 15 May 2008, the company will host an online presentation with a following conference call; this event can be accessed at http://www.speedel.com/section/6/subsections/8. In addition, the conference call may be joined using the following telephone numbers:
Switzerland: 0445 803 409
UK: 0845 245 0248
USA: 1866 789 2220
International +44 (0)1452 565 124
Passcode for all: 43325348
Slides for the webcast will be downloadable 30 minutes before the webcast starts today; a replay of the webcast will be accessible on the company's website for the following 4 weeks.
Financial Calendar 2008
Q2 2008 4 September 2008 (changed from 19 August 2008)
Q3 2008 4 December 2008 (changed from 14 November 2008)
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.
Speedel Pharma AG
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, Aliskiren (Rasilez/Tekturna) 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 four different modes of action, and in addition to SPP100, includes SPP301 (an endothelin receptor A antagonist) in Phase II, SPP200 (a direct thrombin inhibitor) in Phase II, the next generation renin inhibitors SPP635 (in Phase Il), SPP1148 and SPP676 (both in Phase I) and several pre-clinical projects, including SPP2745 (aldosterone synthase inhibitor).
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 80 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.
Speedel was founded in 1998 as a private company. In September 2005 the company's shares were listed on the SWX Swiss Exchange under the symbol SPPN. Further information is available at www.speedel.com.
 Rasilez/Tekturna® are Novartis trademarks.