Speedel Pharmaceuticals, Inc. Announces Financial Results For First Nine Months 2005

BASEL, Switzerland and BRIDGEWATER, N.J., Nov. 16 /PRNewswire-FirstCall/ -- Speedel announced today financial results for the nine months ended 30 September 2005.

Financial Highlights * During the period the company raised CHF 47.9 million in a private equity round, and CHF 70.0 million in a private convertible loan round * On 30 September 2005 liquid assets on hand were CHF 115.1 million * Cash-burn for the first nine months 2005 was CHF 45.6 million compared with CHF 26.9 million for the same period in 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: “The successful listing of our shares and the two last private financing rounds provide us with a solid base for the funding of our robust pipeline. Our expected cash- burn for 2005 is about CHF 60 million and we have liquid assets on hand of CHF 115.1 million to finance the current operations through Q1 2007.”

Excellent clinical newsflow in recent months * 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, 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 for protecting end organs, such as the heart, kidneys and blood vessels

Dr. Alice Huxley, Chief Executive Officer, said: “We continue to create value by driving our key products through critical clinical milestones. Our pipeline is in good shape, and we are delighted to have the backing of a broader base of shareholders as we guide Speedel through its first steps as a public company.”

Financial Key Data (CHF million) 9 m 9 m Change Q3 Q3 Change 2005 2004 2005 2004 Revenues 0.0 0.0 - 0.0 0.0 - Research & Development 41.6 22.9 +18.7 12.2 9.8 +2.4 General & Administration 8.0 3.5 +4.5 2.6 1.2 +1.4 Total operating expenses 49.6 26.4 +23.2 14.8 11.0 +3.8 Operating loss (49.6) (26.4) +23.2 (14.8) (11.0) +3.8 Finance costs, net (1.0) (3.4) -2.4 (0.6) (1.4) -0.8 Taxes 0.7 0.2 -0.5 0.1 0.0 -0.1 Net loss (49.9) (29.6) +20.3 (15.3) (12.4) +2.9 Basic & diluted loss per share/CHF(1) (9.04) (7.05) +1.99 (2.45) (2.89) -0.44 Cash-burn(2) 45.6 26.9 +18.7 13.4 10.6 +2.8 30 Sep 31 Dec Change 05 04 Liquid assets(3) 115.1 42.3 +72.8 (1) Earnings per share are calculated on the weighted average of registered shares outstanding for the periods: 9 months 2005 = 5,523,603; 9 months 2004 = 4,202,754; Q3 2005 = 6,270,305; Q3 2004 = 4,287,005 (2) Cash-burn is determined by the variance of liquid assets (3) Includes cash and cash equivalents and financial assets at fair value through profit and loss

Consolidation is based on IFRS, and 9 months results are unaudited. Complete financial statements and notes for the nine months ending 30 September 2005 can be accessed at http://www.speedel.com/section/6/subsections/3

Research & Development Expenses

These increased by CHF 18.7 million for the first nine months and by CHF 2.4 million for the third quarter compared to the same periods in 2004. A significant portion of this increase relates to a CHF 4.0 million license fee payment to a licensor upon reaching a development milestone, as well as preparatory work for the start of the Phase III programme for SPP301, and expanded activities of the company’s late-stage research unit Speedel Experimenta.

General & Administration Expenses

These increased by CHF 4.5 million for the first nine months and by CHF 1.4 million for the third quarter. This was mainly due to non-recurring expenses for activities undertaken in becoming a listed public company, as well as the hiring of additional staff to support this status going forward.

Finance costs, net

This decreased by CHF 2.4 million for the first nine months and decreased by CHF 0.8 million for the third quarter. This was principally due to the reduction in interest expense after a convertible loan of CHF 53 million was fully converted into shares in March 2005. Subsequently, the company issued another convertible loan of CHF 70 million in August 2005 with a coupon of 2%.

Balance Sheet strengthened

During the first nine months, the company undertook a number of transactions which strengthened the balance sheet. In February 2005 the company raised CHF 47.9 million through the issuance of new shares in a private equity round. In March 2005 a convertible loan of CHF 53 million was fully converted into shares. In August 2005, the company received proceeds of CHF 70 million from the issuance of another convertible loan to its private shareholders.

Share Capital

As of 30 September 2005, Speedel Holding Ltd had 6,905,085 registered shares with a nominal value of CHF 2 per share. These shares have been listed since 08 September 2005 on the SWX Swiss Exchange under the symbol SPPN. In addition the company had outstanding 1,415,510 conditional shares with a nominal value of CHF 2 per share, mainly to cover the company’s share option plan and the convertible loan.

Webcast and Conference Call

At 15.00 CET /14:00 London/ 09:00 EST today 16 November 2005, 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: 018 009 464 UK: 0208 97 47 900 Europe: +41 18009 464 USA: 1 866 804 86 88 Passcode: C891382

Slides for the webcast will be downloadable from 12:00 CET today and the webcast will be accessible on the company’s website until 15 December 2005.

About Speedel

Speedel is a 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), 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 191 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 46 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 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 Pharmacetuicals Inc.

CONTACT: Nick Miles, Director Communications & Investor Relations, T:+41-61-206-40-00, D: +41-61-206-40-14, F: +41-61-206-40-01, M:+41-79-446-25-21, E: nick.miles@speedel.com, or Frank LaSaracina, ManagingDirector, T: +1-732-537-2290, F: +1-732-537-2292, M: +1-908-338-0501, E:frank.lasaracina@speedel.com, both of Speedel Pharmacetuicals Inc.

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