Total revenues and other operating income increased by 15% to €94.3 million.
Operating profit of €15.5 million versus €9.6 million in Q3 2008.
Quarter-end cash and short-term liquidities of €411.9 million.
Undiluted EPS of €0.15 for the quarter.

2009 full year guidance reiterated: total revenues and other operating income expected to grow 20% in constant currencies ; operating profit for 2009 expected to improve significantly compared to 2008; strong cash position.



Leiden, the Netherlands (November 3, 2009) - Dutch biopharmaceutical company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) today announced its financial results for the third quarter of 2009, based on International Financial Reporting Standards (IFRS). These financial results are unaudited.

Highlights:
In the third quarter of 2009 total revenues and other operating income increased by 15% to €94.3 million, compared to €82.1 million in the same quarter of 2008. The increase was driven by a robust 28% growth in product sales and in particular growth of our paediatric and respiratory vaccines.
In December 2008, Crucell announced the discovery of a new class of human monoclonal antibodies (mAbs) with the unprecedented ability to combat a broad range of influenza virus strains[1]. This breadth of protection opens up the new possibility of developing a universal means of influenza control, solving the key challenge in influenza prevention and treatment: the ease with which influenza viruses mutate, leading to new seasonal strains every year, periodic outbreaks of pandemic strains, and the emergence of drug-resistant viruses.
The exciting therapeutic potential of this discovery attracted the attention of global leaders in healthcare innovation, which, in September 2009, resulted in a strategic collaboration between Crucell and Johnson & Johnson (JNJ). This collaboration focuses on the discovery, development and commercialization of monoclonal antibodies and vaccines for the treatment and prevention of influenza and other infectious and non-infectious diseases.
The agreement with JNJ, with a potential deal value of over €1 billion, also includes an 18% equity investment in Crucell at a premium of 30% as well as significant milestones over the development period of the innovation programs. JNJ will hold commercialization rights for products resulting from the collaborations in all countries throughout the world with the exception of the European Union, certain additional European countries and supranational organizations, where Crucell will retain commercialization rights. Additionally Crucell holds all bulk manufacturing rights.
The strategic collaboration with JNJ follows the announcement in August 2009 of an award to Crucell from the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). The award was designed to support early development of Crucell's mAbs for the treatment of seasonal and pandemic influenza. The award provides funding of up to $40.7 million, with additional options that may be triggered at the discretion of the NIH worth a further $28.4 million, bringing the potential total amount to $69.1 million.
Crucell announced $300 million worth of new awards from a large supranational organization for supplies of Quinvaxem®, the first portion of the new 3-year tender period. The new awards are the largest ever received by Crucell and cover the period 2010-2012. With only half of the original tender volume awarded to date the initial amount of $300 million is expected to grow further over the three year period. The new awards are in addition to the $500 million obtained over the tender period 2007-2009. During the first tender round in 2006, Crucell initially received an award of $230 million (Dec 2006) and received additional incremental awards of $130 million and $140 million in May and September, 2008, respectively.
In line with Crucell's strategy to increase its market share and cost efficiency, the company announced the start of its own dedicated marketing and sales organization in the United Kingdom. The acquisition of an experienced team further strengthens Crucell's vaccine sales position in one of the largest vaccine markets in Europe.
Detailed positive results of the Phase II Philippines study of Crucell's rabies monoclonal antibody combination (CL 184) were presented at the XX Rabies in the Americas (RITA) Conference in Quebec, Canada. The start of the third phase II clinical study in India is imminent.
Promising preliminary results of the Phase I study of Crucell's HIV vaccine were presented at La Conférence AIDS Vaccine 2009 in Paris, France, showing that this HIV candidate vaccine is safe and immunogenic.
Crucell announced that the PANFLUVAC consortium consisting of eight European research partners, which includes Crucell, completed the first stage of their phase I clinical trial in healthy volunteers, using a virosomal vaccine against A/H5N1 influenza.
Crucell signed three new license agreements, which includes agreements with Australia-based Patrys Ltd., US-based TapImmune Inc. and US-based Calmune Corporation.
Construction of the new vaccine manufacturing facility in Korea, which started in December 2008, is progressing well. First test runs are planned for the first half of 2010.


Financial Highlights:
Combined total revenues and other operating income for the third quarter were €94.3 million, compared to €82.1 million in the same quarter of 2008. The increase of 15% was mainly driven by strong sales of paediatric and respiratory vaccines. Travel and endemic vaccines also showed solid growth due strong sales of Epaxal®, despite the impact of reduced travel from the economic crisis.
In line with expectations, gross margins were 39% in the quarter, compared to 50% in the same period in the prior year. The timing of development milestone payments from partners significantly influence margins and profitability in the period in which they are recognized. The third quarter of 2008 included €6.0 million milestone payments. The remaining drop in margins is due to unfavorable movement of the US Dollar versus the Euro.
The Company achieved operating profit of €15.5 million in the third quarter of 2009 compared to €9.6 million operating profit in the same quarter of 2008. Operating profits were positively affected by a €8.1 million impairment reversal of two state-of-the-art buildings in Bern (Switzerland). The buildings were impaired in the fourth quarter of 2006 as there was no direct use for them. The buildings are now being used as development production sites for Epaxal® (hepatitis A) and tuberculosis vaccines. The buildings have been adapted to the specific needs of the development programs, which will avoid major spending in the construction of new development facilities.
As part of the strategic collaboration with JNJ, the company sold 14.6 million newly issued ordinary shares to JNJ for an aggregate purchase price of €301.8 million. This included a premium of €69.5 million classified as deferred income, which will be amortized in the coming years.
Income taxes were €4.6 million in the third quarter, mainly due in Switzerland, Spain and Korea. The consolidated effective income tax rate was 32% in the third quarter of 2009. The consolidated profit before tax was reduced by a significant operating loss in the Netherlands as a result of R&D expenses for which no tax benefit is recognized.
Net cash from operating activities in the third quarter improved significantly to €72.1 million, up from minus €9.9 million in the same quarter of 2008. This was driven by the upfront payment of JNJ for participation in Crucell's development programs.
Cash used in investing activities amounted to €118.0 million, which includes a long term deposit of €100.0 million with a maturity of over 3 months, to take advantage of higher yields on longer term deposits.
Net cash from financing activities in the third quarter was €235.0 million, compared to €11.3 million in the same quarter of 2008. This increase reflects the cash proceeds from the issuance of shares to JNJ.
Cash and cash equivalents at the end of the third quarter of €311.6 million, versus €171.0 million at year-end 2008.

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