SOURCE: Speedel Holding AG

March 29, 2007 01:19 ET


BASEL, SWITZERLAND -- (MARKET WIRE) -- March 29, 2007 --

Cash-burn of CHF 75.1 million and year-end liquid assets of CHF 121.1 million in line with guidance

Basel/Switzerland and Bridgewater NJ/USA, 29 March 2007 Speedel (SWX: SPPN) announced today its financial results for the year ending 31 December 2006.

Financial Highlights 2006

  * In March the company raised gross proceeds of CHF 83.95 million
    with its successful first public offering
  * During Q2 and Q3 the company received CHF 15.9 million
    cash-inflow from the early conversion of over 90% of a CHF 70.0
    million convertible loan into equity
  * At 31 December 2006 liquid assets on hand were CHF 121.1 million
  * Cash-burn for 2006 was CHF 75.1 million compared with CHF 59.5
    million for 2005, in line with guidance
  * Loss for 2006 was CHF 91.1 million (CHF 13.28 per share) compared
    with CHF 65.4 million (CHF 11.48 per share) for 2005, mainly
    driven by increased investment in R&D
  * January 2007 bond offering ensures financing of current
    operations until at least the end of 2008

Konrad P. Wirz, Chief Financial Officer, commented: "During 2006 we strengthened our relationships with the capital markets. Significant institutional interests in our company and a bigger free float have improved substantially the liquidity in Speedel's shares on the SWX Swiss Exchange. The cash-burn for 2007 is expected to be between CHF 75-85 million depending on the scope and timing of our development plans for SPP200 and SPP301."

Alice Huxley, Chief Executive Officer, said: "2006 was a challenging year for Speedel. There was significant progress with new data and the registration of SPP100 as the first-to-market renin inhibitor, promising Phase II data from SPP200, the start of a Phase IIa trial with SPP635, and a set back with SPP301. The recent FDA approval of SPP100 (aliskiren,Tekturna[1]) validates renin inhibition as a new therapeutic approach, and substantiates the investment Speedel has made in its next generation renin inhibitor compounds. I am confident that we will manage our pipeline successfully during 2007 and continue to create value in the interests of all our stakeholders."

SPP200 update

SPP200 (pegmusirudin) successfully completed a Phase II trial in August 2006 for the reduction of vascular graft occlusions in patients undergoing chronic haemodialysis for end-stage renal disease. The company is continuing its discussions with the Food and Drug Administration in the US to evaluate the requirements for taking this compound through clinical development to registration. Speedel will announce its decision on the next steps for SPP200 during 2007.

Financial Key Data (1) (CHF million)

|                 | FY 2006  | FY 2005  |Change |Q4 2006 |Q4 2005 |Change|
|Revenues         |       0.0|       0.0|      -|     0.0|     0.0|     -|
|Research &       |    (73.5)|    (52.9)|  +20.6|  (28.3)|  (11.3)| +17.0|
|  Development    |          |          |       |        |        |      |
|General &        |    (12.0)|    (11.0)|   +1.0|   (4.1)|   (3.0)|  +1.1|
|  Administration |          |          |       |        |        |      |
|Total operating  |    (85.6)|    (63.8)|  +21.8|  (32.5)|  (14.2)| +18.3|
|  expenses       |          |          |       |        |        |      |
|Operating        |    (85.6)|    (63.8)|  +21.8|  (32.5)|  (14.2)| +18.3|
|loss             |          |          |       |        |        |      |
|Finance          |     (6.3)|     (2.4)|   +3.9|     0.7|   (1.4)|  -2.1|
|  costs, net     |          |          |       |        |        |      |
|Taxes            |       0.7|       0.8|   -0.1|     0.0|     0.1|  -0.1|
|Loss for the     |    (91.1)|    (65.4)|  +25.7|  (31.6)|  (15.5)| +16.1|
|  period         |          |          |       |        |        |      |
|Basic & diluted  |   (13.28)|   (11.48)|       |  (4.14)|  (2.42)|      |
| loss per        |          |          |       |        |        |      |
| share/CHF (2)   |          |          |       |        |        |      |
|                 |          |          |       |        |        |      |
|Cash-burn (3)    |      75.1|      59.5|  +15.6|    24.0|    13.9| +10.1|
|                 |          |          |       |        |        |      |
|                 |31 Dec 06 |31 Dec 05 |Change |        |        |      |
|Liquid assets (4)|     121.1|     101.1|  +20.0|        |        |      |
|(1)  Numbers may not add up due to rounding                             |
|(2)  Earnings per share are calculated on the weighted average of       |
|     registered shares outstanding for the periods:                     |
|        FY 2006 =6,860,926; FY 2005 =5,698,709;                         |
|        Q4 2006 =7,653,543; Q4 2005 =6,414,271                          |
|(3)  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                                                         |
|(4)  Includes cash and cash equivalents and financial assets at fair    |
|     value through profit or 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 2006 can be accessed at

Research and Development Expenses

R&D expenses increased by CHF 20.6 million for the full year and by CHF 17.0 million for the fourth quarter, compared to the corresponding periods in 2005. The full year increase includes the expanded activities of our in-house research unit Speedel Experimenta with next generation renin inhibitors and other modes of action in cardiovascular and metabolic diseases. The increase in Q4 reflects some additional accruals for the estimated costs of stopping the Phase III programme with SPP301, although the majority of these costs will be incurred during 2007. During Q4 2006 the company also made a CHF 1.5 million license fee payment to a licensor upon reaching a development milestone.

General & Administration Expenses

G&A expenses increased marginally by CHF 1.0 million for the full year and by CHF 1.1 million for the fourth quarter. Two factors have partially offset each other: the one-off costs for the listing of the company's shares on the SWX Swiss Exchange in September 2005, and the increased non-cash expensing of new share options in 2006.

Finance Costs, net

Net finance costs increased by CHF 3.9 million over the previous year. This increase was largely due to the early conversion of CHF 63.6 million of the CHF 70 million convertible loan, which has resulted in bringing forward the non-cash amortisation charge to Q2 and Q3 as the loan has a maturity date of 31 July 2007. The net positive result of CHF 0.7 million in Q4 reflects the reduced amortisation charge in the quarter plus the increased funds available for investment.

Balance Sheet

In March the company raised gross proceeds of CHF 83.95 million in its successful first public offering by placing 500,000 registered treasury shares at CHF 167.90 per share. In addition during Q2 and Q3 the company received CHF 15.9 million in premium proceeds from the early conversion of over 90% of the CHF 70 million convertible loan issued in 2005.

As of 31 December 2006, liquid assets on hand were CHF 121.1 million, compared to CHF 101.1 million at year-end 2005. The company also had only CHF 6.1 million of interest bearing debt at year-end 2006.

Share Capital

On 31 December 2006, Speedel Holding Ltd had 7,663,335 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 657,260 shares with a nominal value of CHF 2 per share, mainly to cover the company's share option plan.

Subsequent Event and 2007 Outlook

In January 2007 the company listed a 4 year convertible bond on the SWX Swiss Exchange (SPP07) yielding CHF 55.5 million in gross proceeds, Demand was substantial enabling the company to raise the conversion premium to 35.9% and a conversion price of CHF 226 per share.

These proceeds together with the cash-reserves at year-end 2006 provide a comfortable base to finance our current operations until at least the end of 2008. This is a conservative statement as it excludes any possible sources of revenues such as royalty income from SPP100.

Operational cash-burn in 2007 is expected to be between CHF 75-85 million and will be determined substantially by the scope and timing of potential further development programmes for SPP200 and SPP301. This guidance excludes any revenue from Novartis sales of SPP100.

Clinical Highlights 2006

  * SPP100 (aliskiren,Tekturna[1])
    Regulatory submission by Novartis in the US in April and in
    Europe in September for the treatment of hypertension. It was
    subsequently approved by the FDA in the US on 06 March 2007
  * SPP301 (avosentan)
    Phase III clinical trial in diabetic kidney disease stopped in
    the interests of patient safety in December
  * SPP200 (pegmusirudin)
    Successful completion in August of a Phase II clinical trial for
    the reduction of vascular graft occlusion with Speedel retaining
    all development, commercialisation and marketing rights
  * SPP635
    Start of Phase IIa study in 35 patients for hypertension in
    October with this proprietary next generation renin inhibitor
  * SPP600, SPP800, and SPP1100 series
    Progression of a variety of proprietary next generation renin
    inhibitors in pre-clinical development

Web cast and Conference Call

At 14.00 CET /13:00 London/ 08:00 EST today 29 March 2007, the company will host a web cast which can be accessed at In addition participants may join a teleconference facility using the following telephone numbers:

Switzerland:           0445 803 409
UK:                    0845 245 0248
USA                    +1 866 789 2220
International          +44 (0) 1452 560 068

Passcode for all:      Conf ID: 2707509
Slides for the webcast will be downloadable from 10:00 CET today and the webcast will be accessible on the company's website until 28 April 2007

Briefing for media

A briefing for media will be held to provide an update on the 2006 financial results and the pipeline:

Thursday 29 March Zurich
10:30 - 11:30 CET
Zurich Development Center
Keltenstrasse 48
8044 Zurich
+41 (0) 44 625 75 75

RSVP: Sandro Poffa, Suter Global Communications, Zurich
+41 (0) 44 316 60 80
+41 (0) 79 424 20 29

Calendar 2007

Full Year 2006 Results        29 March
Annual Report Published       12 April
Q1 Results                    04 May
AGM                           10 May
Q2 Results                    15 August
Q3 Results                    14 November

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[1]), the first-in-class 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 filed by Novartis with the EMEA in the EU in Q3 2006. Our pipeline covers three different modes of action, and in addition to SPP100, includes SPP301 in Phase III (on hold), SPP200 in Phase II, SPP635 in Phase Il, SPP1148 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® is a Novartis trademark

For further information please contact

Nick Miles
Director Communications & Investor Relations
Hirschgässlein 11
CH - 4051 Basel

T +41 (0) 61 206 40 00
D +41 (0) 61 206 40 14
F +41 (0) 61 206 40 01
M +41 (0) 79 446 25 21

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

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