Crucell Announces First Quarter 2007 Results

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Overig advies 09/05/2007 08:04
Dutch biotechnology company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) today announced its financial results for the first quarter ended March 31, 2007, based on International Financial Reporting Standards (IFRS). These financial results are unaudited.

Combined total revenue and total other operating income for the first quarter was €35.2 million, an increase of 156 percent over the same quarter last year. Total revenue includes product sales of €26.6 million, license revenues of €2.7 million and service fees of €2.1 million. Gross margin for the first quarter was €7.4 million or 23.4 percent of total revenue. Total operating expenses were €30.9 million, an increase of €13.2 million over the same quarter last year. The increase of total revenue, total other operating income and total operating expenses over last year is primarily attributable to the acquisitions of Berna, Crucell Vaccines Inc. and SBL in 2006. Net loss for the first quarter was €18.5 million.

Cash and cash equivalents decreased €16.7 million during the first quarter to €141.1 million on March 31, 2007. Net cash used in operations was €13.6 million. Total assets on March 31, 2007 were €607.5 million.

Key Figures First Quarter 2007
(€ million, except net loss per share) Q1 2007 Q1 2006

Revenues and other operating income 35.2 13.7

Net loss (18.5) (15.0)

Net loss per share (basic and diluted) (0.29) (0.29)

Cash and cash equivalents:
at March 31, 2007
at December 31, 2006 141.1 157.8

Crucell's Chief Financial Officer Leonard Kruimer said: "This quarter is the first to include a full quarter's consolidated results of the acquisitions we made last year which were primarily responsible for driving the steep increase in revenues this quarter compared to the same quarter last year. On a pro-forma basis compared to the same quarter last year, sales of both paediatric and travel vaccines showed double digit growth. Our Quinvaxem(TM) vaccine drives the growth of our pediatric vaccines in the developing world. Europe and Asia lead the growth in travel vaccines. Epaxal®, our hepatitis A vaccine experienced strong growth in China, where we have built up our own sales organization in the last year. Historically, vaccine sales are seasonal and are concentrated in the second half of the year. Based on the progress we have made, we now feel comfortable to adjust our guidance for combined total revenue and other operating income to the €220 million to €225 million range for 2007. As stated previously, we expect to achieve operational cash break-even for the full year 2007."


Operational Review First Quarter 2007

Quinvaxem(TM): In March, Crucell announced that children in the Ethiopian capital Addis Ababa, had received their first dose of Quinvaxem(TM) vaccine. Quinvaxem(TM) is a new fully-liquid pentavalent vaccine which protects against five important childhood diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B and Haemophilus influenzae type b (Hib)
DSM Collaboration: In February, Crucell and DSM Biologics agreed to expand their commercial relationship to include new classes of proteins, including biosimilar protein products. The two partners also announced fermentation yields of more than 10 grams per liter for monoclonal antibodies, a breakthrough in the production of protein products.
PER.C6® Technology: New PER.C6® licenses were signed with AbGenomics Corporation, Pfizer Animal Health, Biotecnol SA and the Taiwanese Development Center for Biotechnology (DCB). Licenses with Innogenetics and Mitsubishi Pharma were terminated.
STAR(TM) Technology: In January, Crucell announced STAR(TM) research license agreements with Novo Nordisk A/S and Abbott. Millennium Pharmaceuticals Inc. cancelled its license as a result of a change in strategy.
West Nile: In January, Crucell announced the completion of its Phase I safety study of its West Nile vaccine manufactured using PER.C6® technology. The study demonstrated excellent safety and tolerability.
Tuberculosis: Crucell was awarded a grant of US$5 million from the AERAS Global TB Vaccine Foundation to support the advanced development of the AdVac-based tuberculosis vaccine candidate. A Phase I clinical trial of a recombinant tuberculosis vaccine commenced in October 2006.
Influenza: Crucell announced the signing of an influenza alliance with Taiwanese-based ADImmune Corporation, which will use Crucell's virosome technology to produce influenza vaccines. Crucell will acquire a 20 percent equity stake in ADImmune. Crucell was also awarded a grant of €1.7 million by the European Commission to advance development of a pandemic influenza vaccine.
Malaria: Crucell received a €2.4 million European Union-funded grant in January aimed at advancing the development of a malaria vaccine.

Total Revenue and Other Operating Income
Total revenue and other operating income was €35.2 for the first quarter of 2007, an increase of 156 percent compared to the same quarter last year.

Total revenues for the first quarter of 2007 were €31.5 million, compared to €11.7 million in the same period last year. Revenue consists of product sales, license revenues and service fees.

Product sales amounted to €26.6 million and represent sales of paediatric vaccines (52 percent), travel vaccines (38 percent) and other products (10 percent). Product sales are seasonal and have historically been concentrated in the second half of the year driven mainly by influenza vaccines sales.

License revenues were €2.7 million in the first quarter, an increase of €0.5 million compared to the same quarter last year. License revenues consist of initial payments from new contracts as well as annual and other payments on existing contracts. The increase in license fees is attributable to an increase of PER.C6® and STAR(TM) licenses signed in the first quarter.

Service fees were €2.1 million, compared to €2.4 million last year. Service fees represent revenue for product development activities performed under contracts with partners and licensees and tend to decrease once development programs progress into clinical trials.

Other operating income was €3.7 million for the quarter, compared to €2.0 million in the first quarter last year. Other operating income consists primarily of government grants and miscellaneous income.

Cost of Goods Sold
Cost of goods sold for the first quarter of 2007 amounted to €24.1 million, €22.3 million of which represents product costs and the remainder of €1.8 million represents costs of service activities. Cost of goods sold for the quarter includes a purchase price allocation accounting charge of €3.1 million. The remaining step up on inventory on March 31, 2007 amounts to €6.3 million. We expect to charge this amount into cost of goods sold during the rest of the year when we sell the underlying acquired inventory. The charge is the result of the fair value established for inventory at acquisition date.

Expenses
Total expenses consist of research and development (R&D) expenses and selling, general and administrative (SG&A) expenses.

Total R&D and SG&A expenses were €30.9 million for the first quarter, representing a €13.2 million increase over the same period last year.

R&D expenses for the first quarter amounted to €16.6 million, which represents a €6.0 million increase over the first quarter of 2006. The addition of Berna clinical programs accounted for a €4.9 million increase in R&D costs in the first quarter of 2007. This includes a €2.1 million charge for amortization as a result of the purchase price allocation.

SG&A expenses for the first quarter of 2007 were €14.3 million and represent an increase of €7.3 million over the same quarter in 2006. The increase is attributable to the acquired selling expenses of Berna, SBL and Crucell Vaccines Inc. General and administrative expenses declined slightly compared to the same quarter last year.

Net Loss
The Company reported a net loss for the first quarter of 2007 of €18.5 million, or €0.29 net loss per share, which is equal to the net loss per share for the first quarter last year.

Cash Flow and Cash Position
Cash and cash equivalents decreased by €16.7 million in the first quarter to €141.1 million.

Net cash used in operating activities in the first quarter of 2007 was €13.6 million. In working capital, customer payments resulted in a net cash inflow of €25.1 million, offset by the inventory build-up of €5.9 million mainly related to Quinvaxem(TM) vaccine production and a reduction of €10.8 million in trade accounts payable primarily related to payments for Quinvaxem(TM) antigens.

Net cash used in investing activities amounted to €2.4 million. Capital expenditure amounted to €4.2 million and interest received to €1.4 million.

Balance Sheet
Property plant and equipment amounted to €137.3 on March 31, 2007.
Intangible assets represent assets acquired in acquisitions and amount to €108.0 million, which represent acquired in-process R&D; developed technology; patents and trademarks; and value of customer and supplier relationships.

Investments in associates and joint ventures amount to €5.5 million and represent the investments in Pevion, Kenta and Percivia. The Company's investment in Galapagos NV is classified under "Available-for-sale-investments".

Total equity amounts to €475.5 million. A total of 64,914,275 million ordinary shares were issued and outstanding on March 31, 2007.

Other current liabilities decreased by €8.4 million as accrued expenses and other accruals decreased during the quarter.


Outlook
Crucell expects combined full year 2007 total revenue and total other operating income in the €220 to €225 million range. The Company aims to achieve cash break-even on our 'net cash from operating activities' line in our cash flow statement for the full year 2007.

Forward-looking statements
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 July 6, 2006, and the section entitled "Risk Factors". The Company prepares its financial statements under International Financial Reporting Standards (IFRS) with a reconciliation to the generally accepted accounting principles in the United States (US GAAP).




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