Total revenues and other operating income of €365.4 million for the
full year 2010 compared to €358.0 million in 2009.
Due to write-downs of Quinvaxem® inventory and higher operating expenses, operating loss for the year was €34.3 million compared to €39.0 million operating profit in 2009. The year ended with a net loss of €27.6 million compared to €23.9 million net profit in the previous year and
undiluted EPS of minus €0.34 compared to €0.34 in 2009.

Leiden, the Netherlands (February 7, 2011) - Dutch biopharmaceutical company Crucell N.V. (NYSE Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announced its financial results for the fourth quarter and the full year of 2010, based on International Financial Reporting Standards (IFRS). These financial results are unaudited.

Business Highlights:

On October 28, 2010 and November 9, 2010 Crucell announced that it put a temporary hold on all shipments of Quinvaxem® and Hepavax-Gene® and suspended production at its Shingal facility in Korea as the facility's sterile operation had been compromised due to a microbiological contamination. In December 2010, Crucell resumed shipments of the non-contaminated stock of Quinvaxem®.

In December 2010, the Korea Food & Drug Administration (KFDA) audited the Shingal facility and informed Crucell in January 2011 that it supported the restart of manufacturing. Crucell has started commercial manufacturing of Quinvaxem® at full capacity and will release Quinvaxem® to the market through the normal release procedures. In the third quarter financial results, Crucell took a €22.8 million inventory provision on Quinvaxem® stock related to the Korea manufacturing issues.

In December 2010, Crucell was able to release a batch of Quinvaxem® that had previously been provisioned, resulting in a decrease in operating loss of €1.9 million in the fourth quarter. The release of two further Quinvaxem® batches currently also fully provisioned for, is dependent on the results of further assessments by the company and consultation with regulatory authorities. Release of these two batches would decrease the operating loss for the year 2010 by another €4.2 million.
On December 8, 2010 Johnson & Johnson and Crucell announced that Johnson & Johnson is making a recommended cash offer for all of the issued and outstanding ordinary shares in the capital of Crucell N.V. at an offer price of €24.75 per share. The Offer represents a premium of 58% over the €15.70 closing price of the Ordinary Shares as of 16 September 2010, the day before Johnson & Johnson and Crucell announced they were in negotiations for the Offer, and a premium of 63% over the 30-day trading average of the Ordinary Shares of €15.20 as of 16 September 2010.

On December 10, 2010 Crucell held an informational Extraordinary General Meeting of Shareholders to discuss Johnson & Johnson's offer.

In November 2010 Crucell announced the start of a discovery program leading to the development and commercialization of a Human Papilloma Virus (HPV) vaccine. This discovery program is part of the existing strategic collaboration with Johnson & Johnson, through its subsidiary Ortho-McNeil-Janssen Pharmaceuticals, Inc., signed in September 2009, to develop innovative products, including antibodies for influenza prevention and treatment.
Financial Highlights 2010:

The Company announced combined total revenues and other operating income of €365.4 million, compared to €358.0 million in 2009, in-line with prior guidance given to the market.


Product sales were €290.6 million, representing sales of paediatric vaccines (61%), travel and endemic vaccines (25%), respiratory vaccines (7%), and other products (7%). Higher sales of travel and endemic vaccines were more than off-set by lower sales of respiratory vaccines due to the limited availability of flu antigen, weaker overall demand and the temporary suspension of Quinvaxem® shipments.


Gross margins were 30%, compared to 42% in 2009. Gross margins were significantly impacted by the provision for Quinvaxem® inventory, pricing of Quinvaxem® sales, variation in product mix and negative operating variances.

Research and development (R&D) expenses increased to €100.0 million, compared to €70.2 million in 2009. R&D spending accelerated significantly in line with guidance, mainly as a result of an increase in clinical development expenses.

Operating loss was €34.3 million for 2010, compared to €39.0 million operating profit in 2009, due to write-downs of Quinvaxem® inventory and higher operating expenses.

Net loss was €27.6 million for 2010, compared to a net profit of €23.9 million in 2009. This translates to a net loss per share of €0.34, compared to a net profit per share of €0.34 in 2009.

Cash used in operating activities was €36.4 million compared to cash from operating activities of €76.9 million in 2009. This is due to lower net results, movements in working capital and receipt of significant upfront payments in 2009 related to the collaboration agreement with Johnson & Johnson.

Cash used in investing activities was €15.7 million in 2010, which is mainly due to the purchase of property, plant & equipment and investments in intangible assets, partially offset by proceeds from financial assets. The latter are cash proceeds from deposits with maturities over 3 months at the beginning of the period.

Net cash used in financing activities in 2010 amounted to €50.7 million due to the repayment of financial liabilities to reduce interest expenses

Cash and cash equivalents decreased by €95.8 million in 2010 to €232.0 million.

Manufacturing & Licensing Agreements:

Crucell announced that UK-based Eden Biodesign Limited, signed a non-exclusive Vendor Network Agreement, whereby Eden has become a pre-approved authorized provider of services for contract manufacturing on Crucell's proprietary PER.C6® cell-line technology. Under the terms of the agreement Eden will be able to offer Contract Manufacturing Services to Crucell's PER.C6® licensees in the field of vaccines and gene therapy. Financial details of the agreement were not disclosed. [Oct 2010]

Patents:

In Q4 2010 Crucell was granted a total of 64 patents, including patents for:
Aspects of PER.C6® cell lines and recombinant adenovirus technology, in Canada
Aspects of PER.C6® protein expression technology, in the U.S.
Aspects of AdVac® technology, in Europe Canada and Mexico
Aspects of influenza virus production using PER.C6® technology, in the U.S.
Aspects of improved adenoviral AdVac® vectors, in the U.S.
Elements of STAR® technology, in the U.S., Eurasia, Japan and Europe
Aspects of recombinant measles virus vector technology, in the U.S.
Cell lines for improved adenovirus production, in the U.S.

Financial Review Fourth Quarter 2010
Total Revenues and Other Operating Income
The Company announced combined total revenues and other operating income of €81.6 million, compared to €111.3 million in the fourth quarter of 2009. The decrease was mainly driven by the suspension of Quinvaxem® shipments.

Product sales in the fourth quarter of 2010 decreased 32% over the same quarter in 2009 to €62.4 million and represent sales of paediatric vaccines (36%), travel and endemic vaccines (34%), respiratory vaccines (18%), and other products (12%).

License revenues were €9.7 million in the fourth quarter, compared to €11.3 million in the fourth quarter of 2009. The decrease was mainly due to lower milestone payments in the fourth quarter of 2010.

Service fees for the quarter were €0.4 million, compared to €2.9 million in the same quarter of 2009. Service fees represent revenues for product development activities performed under contracts with partners and licensees.

Other operating income was €9.2 million for the quarter, compared to €6.0 million in the fourth quarter of 2009, reflecting a higher lever of R&D reimbursements.

Cost of Goods Sold
Cost of goods sold for the fourth quarter of 2010 amounted to €43.5 million compared to €56.2 million in the same quarter of the prior year. €42.3 million represents product costs; and €1.3 million the cost of service and license activities.

Gross margins were 40% compared to 47% in the fourth quarter of 2009. This decrease is due to negative operating variances, product mix and the one-off impact from the voluntary withdrawal of Vivotif®, partially off-set by the reverse of some of the Quinvaxem® stock provision in the fourth quarter of 2010.

Expenses
Total expenses consist of research and development (R&D) expenses, marketing and sales (M&S) and general and administrative (G&A) expenses. Total expenses for the fourth quarter were €50.1 million, representing a €13.0 million increase over the same period in 2009.

R&D expenses for the fourth quarter amounted to €29.8 million, representing an increase of €7.4 million versus the fourth quarter of 2009 as R&D program spending accelerated in line with guidance.

SG&A expenses for the quarter were €17.6 million compared to €13.8 million in the fourth quarter of 2009. This increase was mainly due to higher M&S and IT expenses.

During the fourth quarter we also incurred €2.7 million transaction costs related to the offer of Johnson & Johnson.

Operating loss of €12.0 million for the fourth quarter, compared to an operating profit of €18.0 million in the same period of 2009.

Taxation
In December 2010, Crucell was granted a tax holiday in Switzerland for the period 2011 to 2020. This tax holiday will reduce the effective tax rate and resulted in a Q4 one-time benefit of EUR 3.3 million.


Net Result
Net loss of €7.5 million was reported for the fourth quarter of 2010, compared to a net profit of €15.6 million in the fourth quarter of 2009. Net loss per share is €0.09, compared to a net profit per share of €0.19 in the same period of 2009.

Balance Sheet
Tangible fixed assets amounted to €256.7 million on December 31, 2010. Intangible assets amounted to €85.0 million, including acquired in-process research and development, developed technology, patents and trademarks, the value of customer and supplier relationships, and capitalized IT investments.

Investments in associates and joint ventures amounted to €14.3 million and mainly represent investments in AdImmune and the PERCIVIA PER.C6® . Crucell's investment in is classified under available-for-sale investments.

Total equity on December 31, 2010 amounted to €786.4 million. A total of 81.7 million ordinary shares were issued and outstanding on December 31, 2010.

Cash Flow and Cash Position
Cash and cash equivalents decreased by €60.1 million during the fourth quarter to €232.0 million.

Cash used in operating activities of €30.9 million compared to cash from operating activities of €31.7 million in the same period of 2009, mainly due to net results and the movement of inventory balances due to antigen purchases in the fourth quarter of 2010.

Cash used in investing activities amounted to €13.8 million in the fourth quarter, which is mainly due to the purchase of property, plant & equipment and investments in intangible assets, offset by proceeds from financial assets.

Net cash used in financing activities in the quarter amounted to €15.8 million due to the repayment of financial liabilities.