SOURCE: Speedel Holding AG

May 15, 2008 01:08 ET

SPEEDEL ANNOUNCES FINANCIAL RESULTS FOR FIRST QUARTER 2008

BASEL, SWITZERLAND--(Marketwire - May 15, 2008) -


Reduced net loss for the period


Basel/Switzerland and Bridgewater NJ/USA, 15 May 2008 Speedel Holding Ltd. (SWX: SPPN) today announced financial results for the three months ending 31 March 2008.

Financial Highlights

  * CHF 2.2 million recognised as estimated revenues for Q1 2008 from
    sales of SPP100/Aliskiren (Tekturna/Rasilez®)[1][1] 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®)[1] 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."

Financial Key Data [i] (CHF million)


+-------------------------------------------------------------------+
|                                  |   Q1 2008 |   Q1 2007 | Change |
|----------------------------------+-----------+-----------+--------|
| Revenues [ii]                    |       2.2 |       0.0 |   +2.2 |
|----------------------------------+-----------+-----------+--------|
| Research & Development           |    (11.4) |    (11.6) |   +0.2 |
|----------------------------------+-----------+-----------+--------|
| General & Administration         |     (2.7) |     (3.4) |   +0.7 |
|----------------------------------+-----------+-----------+--------|
| Total                  operating |    (14.1) |    (14.9) |   +0.8 |
| expenses                         |           |           |        |
|----------------------------------+-----------+-----------+--------|
| Operating loss                   |    (11.9) |    (14.9) |   +3.0 |
|----------------------------------+-----------+-----------+--------|
| Finance costs, net               |     (1.0) |     (0.1) |   -0.9 |
|----------------------------------+-----------+-----------+--------|
| Taxes                            |       0.0 |       0.0 |        |
|----------------------------------+-----------+-----------+--------|
| Loss for the period              |    (12.9) |    (15.0) |   +2.1 |
|----------------------------------+-----------+-----------+--------|
| Basic   &   diluted   loss   per |    (1.66) |    (1.96) |  +0.30 |
| share/CHF [iii]                  |           |           |        |
|----------------------------------+-----------+-----------+--------|
|                                  |           |           |        |
|----------------------------------+-----------+-----------+--------|
| Cash-burn [iv]                   |      15.2 |      14.9 |   +0.3 |
|----------------------------------+-----------+-----------+--------|
|                                  |           |           |        |
|----------------------------------+-----------+-----------+--------|
|                                  | 31 Mar 08 | 31 Dec 07 | Change |
|----------------------------------+-----------+-----------+--------|
| Liquid assets [v]                |      94.5 |     107.9 |  -13.4 |
+-------------------------------------------------------------------+

Footnotes i-v 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 2008 can be accessed at http://www.speedel.com/section/6/subsections/4.

Revenues

Accrued revenues reflect management's best estimate regarding royalty income on global net sales of SPP100/Aliskiren (Tekturna/Rasilez®)[1] 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.

Net loss

The reduced net loss for the period under review arises mainly from the increase in recognised revenues from SPP100/Aliskiren.

Balance Sheet

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.

Share Capital

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.

Cash-burn

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[1][1], the single-tablet
    combination of two antihypertensive drugs - SPP100/Aliskiren
    (Tekturna/Rasilez®)[1][1] 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)

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, Aliskiren (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 four different modes of action, and in addition to SPP100, includes SPP301 (an endothelin A receptor 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 SPP2000 (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.



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

[i] Numbers may not add up due to rounding
[ii] Management`s best estimate
[iii] Earnings per share are calculated on the weighted average of
registered shares outstanding for the periods:
     Q1 2008 = 7,801,782; Q1 2007 =
7,666,347

[iv] 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
[v] Includes cash and cash equivalents and financial assets at fair
value through profit and loss


For further information please contact

Harald F. Schaefer, Ph.D.
Director Communications & Investor Relations
Speedel
Hirschgässlein 11
CH - 4051 Basel
Switzerland

T +41 (0) 61 206 40 00
D +41 (0) 61 206 40 14
F +41 (0) 61 206 40 01
M  +41 (0) 79 629 76 71
E harald.schaefer@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




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