- Agreements signed for further development and commercialization of Ebola and Marburg vaccines.
- Strong US and European endorsement of PER.C6®-based vaccine technology.
- Five new PER.C6® licensing deals secured.
- Revenue up 50%; strong increase in service revenue from contracts with partners and licensees.
Leiden, The Netherlands, April 18, 2005 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL) today announced its financial results for the first quarter of 2005. Crucell's revenue for the first quarter was € 6.0 million (US$ 7.7 million), up 50% over the same quarter in 2004. The Company's net loss for the quarter decreased 24% to € 5.3 million (US$ 6.8 million). Positive cash-flow of € 0.2 million (US$ 0.2 million) for the quarter resulted in a cash balance of € 76.9 million (US$ 99.3 million) at March 31, 2005. Positive cash flow was mainly due to proceeds from the issuance of shares upon share option exercises.
"The new licensing deals and new agreements closed in the first quarter are yet another clear indication that Crucell's technology is receiving strong industry support as a manufacturing platform," said Crucell's Chief Financial Officer Leonard Kruimer. "Crucell's core vaccine product programs are all progressing as planned. We expect the recently signed HHS pandemic flu contract as well as the recently signed Ebola vaccine manufacturing contract with the NIH to further accelerate growth in our product development. While we expect these new contracts to contribute to top line growth, we maintain our guidance for the full year cash burn at € 15 - 20 million at this time."
Key Figures First Quarter 2005
(€ million, except net loss per share data)
|
|
Q1 2005
|
% change |
Q1 2004 |
|
Revenue |
6.0 |
50% |
4.0 |
|
Net loss |
(5.3) |
(24%) |
(7.0) |
|
Net loss per share (basic and diluted) |
(0.14) |
(26%) |
(0.19) |
|
|
|
|
|
|
Cash and cash equivalents:
March 31, 2005
December 31, 2004 |
76.9
76.7 |
|
|
Operational Review First Quarter 2005
STAR(TM) technology: Genentech entered the second phase of its evaluation of Crucell's STAR(TM) technology. The evaluation is focused on the ability of STAR(TM) technology to increase production yields of Genentech's proprietary systems.
Ebola: Crucell extended its Cooperative Research and Development Agreement (CRADA) with the NIH's Vaccine Research Center (VRC) for the development and manufacturing of vaccines against Ebola, Marburg and Lassa infections. Crucell also obtained an exclusive license to patents of the NIH to develop and commercialise vaccines against Ebola.
Influenza: Crucell's cell culture technology became part of a major U.S. government influenza pandemic vaccine program. Sanofi pasteur / Crucell is the only manufacturer in the European FLUPAN collaboration. Crucell became a new member of the Influenza Vaccine Supply (IVS) International Task Force.
Licensing: New PER.C6® licensing deals were secured by the Crucell-DSM alliance with Roche, JCR Pharmaceuticals and Mitsubishi. Crucell signed further PER.C6® deals with SingVax and Vascular Biogenics Ltd.
Intellectual property: Crucell received a European patent covering PER.C6® for vaccine production and other European and US patents covering PER.C6® for protein production. Crucell also received US patent covering its STAR(TM) technology.
Midkap: Crucell was included in the Amsterdam Midkap (AMX) index as of March 2005.
SEC Annual Report: Crucell filed its Form 20-F Annual Report with the United States Securities and Exchange Commission (SEC) on April 14, 2005. The report is available on the SEC website at www.sec.gov (file reference: 000-30962) and on the Investor/Financial Reports page of Crucell's website www.crucell.com.
Details of the Financial Results
Revenue
Crucell's revenue for the first quarter 2005 was € 6.0 million (US$ 7.7 million), compared to € 4.0 million (US$ 5.2 million) in the same quarter last year. License revenue in the first quarter 2005 amounted to € 1.8 million (US$ 2.4 million), compared to € 2.2 million (US$ 2.8 million) in the first quarter 2004. Average initial payments were higher in the first quarter of 2004. License revenue consisted of initial payments from new contracts as well as annual and other payments on existing contracts.
Service fees amounted to € 2.5 million (US$ 3.2 million), a more than 3-fold increase over the level of service fees of € 0.6 million (US$ 0.8 million) recorded in the first quarter 2004. Service fees represent revenues for activities performed under contracts with partners and licensees. Service fee revenues increased due to increased service activities in influenza and malaria programs.
Government grants and other revenues amounted to € 1.6 million (US$ 2.1 million), compared to € 1.2 million (US$ 1.5 million) in the same quarter last year.
Crucell seeks to increase revenues from year to year. The Company has in the past experienced significant fluctuations in quarterly revenues and expects to continue to experience such fluctuations in the future.
Results
The Company reported a net loss for the first quarter 2005 of € 5.3 million (US$ 6.8 million), or € 0.14 net loss per share (US$ 0.18). This compares to a net loss of € 7.0 million (US$ 9.1 million), or € 0.19 net loss per share (US$ 0.25) for the first quarter 2004.
Total costs and expenses increased 2.3% versus the same quarter last year. The decrease in net loss to € 5.3 million (US$ 6.8 million) is attributable to the increase in revenue. Total research and development (R&D) expenses in the first quarter 2005 were € 5.9 million (US$ 7.6 million), excluding cost of service fees. This compares to a figure of € 6.1 million (US$ 7.9 million) in the first quarter of 2004.
Cost of service fees are from this time forward reported separately from R&D expenses. Cost of service fees represents expenses incurred for activities performed under contracts with partners and licensees. Cost of service fees increased to € 1.9 million (US$ 2.4 million) during the first quarter, up from € 0.4 million (US$ 0.5 million) in the first quarter last year. The increase in cost of service fees is directly related to the significant increase in contract-related service activities.
Selling, general and administrative (SGA) expenses for the first quarter 2005 were € 2.7 million (US$ 3.5 million), compared to € 4.1 million (US$ 5.3 million) for the same quarter in 2004. This reduction in SGA expenses is due to a reduction in warrant and non-employee stock option expenses and other general and administrative expenses.
Cash Flow and Cash Position
Cash and cash equivalents increased by € 0.2 million (US$ 0.2 million) in the first quarter of 2005. Crucell's cash and cash equivalents amount to € 76.9 million (US$ 99.3 million) on March 31, 2005.
Cash used in operating activities in the first three months of 2005 was € 3.5 million (US$ 4.6 million). Net cash used in investing activities amounted to € 0.3 million (US$ 0.4 million) in the first quarter, representing equipment purchases.
The Company generated € 4.0 million (US$ 5.2 million) in financing activities. This is primarily attributable to proceeds from the issuance of ordinary shares after employee stock options were exercised during the quarter.
Note: Euros are converted to US Dollars at the March 31, 2005 exchange rate of 1.2916 US$ per 1.0 €.
About Crucell
Crucell N.V. is a biotechnology company focused on developing vaccines and antibodies that prevent and treat infectious diseases, including Ebola, influenza, malaria, West Nile virus and rabies. The Company's development programs include collaborations with sanofi pasteur for influenza vaccines, the U.S. National Institutes of Health for Ebola and malaria vaccines, and GlaxoSmithKline (GSK), Walter Reed Army Institute of Research and New York University for a malaria vaccine. Crucell's products are based on its innovative PER.C6® technology, which offers a safer, more efficient way to produce biopharmaceuticals. The Company licenses its PER.C6® technology to the biopharmaceutical industry on a mostly non-exclusive basis. Licensees and partners include DSM Biologics, GSK, Centocor/J&J and Merck & Co., Inc. Crucell is headquartered in Leiden, The Netherlands, and is listed on the Euronext and NASDAQ stock exchanges (ticker symbol CRXL). For more information, please visit www.crucell.com.
This press release contains forward-looking statements that involve inherent risks and uncertainties. We have identified certain important factors that may cause actual results to differ materially from those contained in such forward-looking statements. For information relating to these factors please refer to our Form 20-F, as filed with the U.S. Securities and Exchange Commission on April 14, 2005, and the section entitled "Risk Factors". The company prepares its financial statements under generally accepted accounting principles in the United States.
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