. Total revenues and other operating income of €78.7 million, an increase of 32% compared to Q2 2008.
. Gross margin 39%, up from 36% in Q2 2008.
. Operating profit of €3.2 million versus operating loss of €9.0[1] million in Q2 2008.

2009 full year guidance reiterated: total revenues and other operating income expected to grow 20% in constant currencies[2] ; operating profit for 2009 expected to improve significantly compared to 2008; solid cash flow.

Leiden, the Netherlands (August 11, 2009) - Dutch biopharmaceutical company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) today announced its financial results for the second quarter of 2009, based on International Financial Reporting Standards (IFRS). These financial results are unaudited.

Highlights:
In the second quarter of 2009 total revenues and other operating income increased by 32% to €78.7 million, compared to €59.6 million in the same period of 2008. The increase was mainly driven by growth in sales of the pentavalent children's vaccine Quinvaxem®, despite some phasing of shipments into the second half of the year. Travel vaccines and other products also showed double digit sales growth.
Crucell announced collaboration with the PATH Malaria Vaccine Initiative (MVI) and the United States Agency for International Development (USAID) Malaria Vaccine Development Program (MVDP) to accelerate development of its malaria vaccine.
Crucell announced positive results of a second Phase II clinical study of its rabies monoclonal antibodies, which started in May 2008 (the Philippines).
Crucell signed a non-exclusive PER.C6® research license agreement with Momotaro-Gene Inc. for the production of a gene therapy product for the treatment of prostate cancer, including the right to perform a first-in-man Phase I clinical trial program.
Crucell signed a non-exclusive PER.C6® research license agreement with Australian-based Patrys Ltd. for the production of several undisclosed antibodies.
Construction of our new vaccine manufacturing facility in Korea, which started in December 2008, is progressing well. Structural work on the site has been completed and electrical and mechanical engineering is progressing according to plan. First test runs are planned for the first half of 2010.

Financial Highlights Second Quarter 2009:
Combined total revenues and other operating income for the second quarter were €78.7 million, compared to €59.6 million in the same quarter of 2008. The increase of 32% was mainly driven by growth in sales of our paediatric vaccines, in particular Quinvaxem®. Travel vaccines and other products also showed double digit sales growth.
Gross margins were 39% in the quarter, compared to 36% in the second quarter of 2008. Although our margins improved significantly versus last year, a stronger Swiss Franc against the Euro and Korean Won against the US Dollar increased costs and offset the margin improvement. These currency effects will continue to put pressure on margins.
The Company achieved operating profit of €3.2 million in the second quarter of 2009. This represents a significant improvement over the €9.0[3] million operating loss in the same quarter of 2008. Income tax charges and currency effects resulted in a net loss of €1.8 million in the quarter, a significant improvement compared to a net loss of €7.4 million in the same quarter of 2008.
Income taxes were €2.2 million in the second quarter, mainly payable in Korea and Sweden. Income tax charge compared to profit before tax is relatively high. Operating profits in Korea and Sweden are partially offset by an operating loss in the Netherlands, effectively reducing profit before tax on a consolidated basis.
Net cash used in operating activities in the second quarter was €6.9 million, down from €18.0 million used in the same quarter of 2008.
Cash used in investing activities amounted to €10.1 million, reflecting the capital investment in our new plant in Korea.
Cash and cash equivalents at the end of the second quarter of €121.6 million, versus €171.0 million at year-end 2008.

Cash & cash equiv.:
- June 30, 2009
- Dec 31, 2008
- June 30, 2008
121.6
171.0
106.9

Crucell's Chief Executive Officer Ronald Brus said:

"We are very pleased to report positive operating profits for both the second quarter and the first half of the year. Our margins improved significantly versus last year, despite increased costs due to negative currency effects. We continue to be confident of our business prospects for the remainder of the year and therefore maintain our guidance for 2009.

Quinvaxem®-our most important paediatric vaccine-once again made an important contribution to our revenues in the second quarter despite some phasing of shipments into the second half of the year. Looking forward, Quinvaxem® is well-positioned for the award of new tenders for the period 2010-2012, the first tranche of which is expected to be announced soon.

During the second quarter we were also able to report significant progress on our pipeline programs. Our recent endorsement by the MVI, the US Malaria Vaccine Initiative, reflects the growing recognition that Crucell is bringing innovative solutions to global health."


Product and Business Update

Product Update:
Product sales in the second quarter of 2009 amounted to €66.4 million and represent sales of paediatric vaccines (60%), travel and endemic vaccines (24%), and other products (16%).

Paediatric
Sales of our paediatric vaccines, particularly driven by Quinvaxem®, continued to show solid growth in the second quarter 2009 despite a very strong first quarter and some phasing of shipments into the second half of the year.

Quinvaxem®: Fully liquid pentavalent vaccine against five important childhood diseases.
Hepavax-Gene®: Recombinant vaccine against hepatitis B.
Epaxal® Junior: Paediatric dose (0.25mL) of Epaxal®, the only aluminum-free vaccine against hepatitis A for use in children.
MoRu-Viraten®: Vaccine for protection against measles and rubella (for all age groups).

Travel and Endemic
In the second quarter of 2009, sales of our travel and endemic portfolio showed good growth. Our travel portfolio has seen limited impact from the economic crisis as we were able to compensate sales declines with good uptake of our hepatitis A vaccine Epaxal® in new territories. In the second half of the year, in particular in the third quarter, we expect weakening in the sales growth of our travel portfolio as reduced travel, particularly in the Nordic region, is anticipated.

Epaxal®: Aluminum-free vaccine against hepatitis A.
Vivotif®: Oral vaccine against typhoid fever.
Dukoral®: Oral vaccine against cholera and diarrhea caused by ETEC (enterotoxigenic E. coli).

Respiratory
We typically have no sales in respiratory products at the beginning of a calendar year, due to normal seasonality of the flu business.

Inflexal® V: A virosomal adjuvanted vaccine against influenza (for all age groups). Due to the seasonality of the product, we build inventory in the first half of the year to sell flu vaccines in the second half of the year.


Pipeline Update:
Flavimun® - Live Attenuated Yellow Fever Vaccine: Flavimun® was submitted for registration in Switzerland in March 2009. Submission in Germany is expected before the end of 2009.

Influenza - Seasonal Flu Vaccine (FluCell collaboration with sanofi pasteur): This seasonal influenza vaccine is being developed by Crucell's partner sanofi pasteur, using PER.C6® technology. Phase II testing of the cell-based influenza vaccine was initiated in the USA in November 2007. In the third quarter of 2008, Crucell received a milestone payment from sanofi pasteur for progress of the Phase II trials involving healthy adult volunteers in the USA. The trials focus on the safety profile and immunogenicity of the cell-based vaccine. All data collected so far confirm that the PER.C6® cell line supports the growth of all flu virus strains in high quantities. The cell line has also been found to be commercially scalable to any desired scale and no problems related to the PER.C6® cell line have been encountered to date.

Rabies Human Monoclonal Antibody Combination (CL 184): Crucell's monoclonal antibody combination against rabies is being developed in close collaboration with sanofi pasteur using Crucell's PER.C6® manufacturing technology. In 2008, Crucell initiated two Phase II studies in the USA and the Philippines. Promising Phase I data in 2007 showed no serious adverse effects and demonstrated the expected rabies neutralizing activity upon administration. The rabies human monoclonal antibody combination was granted a Fast Track designation by the FDA Department of Health and Human Services, ensuring priority handling of the regulatory dossier. Under the terms of the collaboration agreement with sanofi pasteur, Crucell will be responsible for manufacturing the commercial product and has retained exclusive distribution rights in Europe, co-exclusive distribution rights in China and the rights to sell to supranational organizations such as UNICEF, while sanofi pasteur will have exclusive distribution rights for all other territories and co-exclusive distribution rights in China. This antibody combination is designed to be used in combination with a rabies vaccine for post-exposure prophylaxis (PEP) against this fatal disease.
Positive preliminary results of our Phase II US study were presented to rabies experts at the 19th annual RITA meeting in Atlanta on October 1, 2008. These results triggered another milestone payment from sanofi pasteur at the end of September, as part of the total eligible amount of €66.5 million.
A second Phase II clinical study evaluating the monoclonal antibody combination together with a rabies vaccine in healthy children and adolescents was conducted in the Philippines from May to October 2008. The completion of this study triggered another milestone payment from sanofi pasteur, at the end of October. In June 2009, Crucell announced the results of the Philippines study, which showed that the antibody combination was safe and well tolerated. Neutralizing activity levels in subjects given the antibody product were similar to those in subjects given human immunoglobulin (HRIG), the current standard for inducing immediate, passive immunity. All study participants reached adequate immunity levels. This study in children further broadens the potential patient population for Crucell's rabies monoclonal antibody combination. Detailed results of this study will be presented at the XX Rabies in the Americas RITA conference in Quebec, Canada on 18-23 October 2009.
An additional Phase II study in healthy adults evaluating Crucell's monoclonal antibody in combination with a rabies vaccine is scheduled to start in India in the second half of 2009.

Tuberculosis Vaccine based on AdVac®/PER.C6® Technologies: Development of the candidate vaccine AERAS-402/Crucell Ad35 is being carried out in collaboration with the Aeras Global TB Vaccine Foundation. Data from all AERAS-402/Crucell Ad35 trials support the immunogenicity and acceptable safety profile of the TB vaccine candidate at all dose levels evaluated.
Phase I: US Phase I trial in healthy adults not previously immunized with Bacille Calmette-Guérin (BCG), the traditional TB vaccine, has been completed and has demonstrated that AERAS-402/Crucell Ad35 is safe in this population.
Results of a second study in South Africa showed encouraging results, notably CD8-cell immune responses that are much higher than those seen in humans in any previous TB vaccine study.
Two Phase I studies in healthy adults in St. Louis, USA, focusing on the immunogenicity and safety of two AERAS-402/Crucell Ad35 boost doses administered at three to six month intervals after BCG priming in healthy adults have been completed. Data from these studies specifically indicate that two injections of AERAS-402/Crucell Ad35 are immunogenic, with an acceptable safety profile, when used with a BCG-prime/AERAS-402/Crucell Ad35 in BCG vaccinated healthy adults regardless of the boosting interval. This immune response is greater than that detected in the absence of BCG prime, supporting the possible utility of AERAS-402/Crucell Ad35 as a booster vaccine. BCG prime alone shows limited efficacy.
In October 2008, a Phase I clinical trial of the jointly developed TB vaccine was started in Kenya. The study is being conducted by the KEMRI/Walter Reed Project-Kisumu at their Kombewa Clinical Trials Center near Kisumu, in Western Kenya. Its main objective will be to test the safety of the candidate vaccine in BCG-vaccinated adults with or without latent tuberculosis. This study is fully enrolled and now in its follow-up period, with no safety issues identified.
In April 2009, a Phase I clinical trial in infants of the jointly developed TB vaccine candidate AERAS-402/Crucell Ad35 was started in South Africa. This is the first clinical trial designed to test this vaccine candidate in infants. The Phase I study of AERAS-402/Crucell Ad35 will be conducted by the South African Tuberculosis Vaccine Initiative (SATVI) in the Western Cape region of South Africa. The main objective of the study will be to test the safety of the TB vaccine candidate in infants previously vaccinated with BCG vaccine, which is currently the only vaccine licensed to help prevent TB.
Phase II: In October 2008 enrollment for the first Phase II study of AERAS-402/Crucell Ad35 in Cape Town, South Africa was started. The study is being conducted by the University of Cape Town Lung Institute in conjunction with the South African Tuberculosis Vaccine Initiative. The candidate is being tested in 82 adults who have had active TB. No evidence of an unacceptable safety issue has been found in its dose escalation design after enrollment and vaccination of 48 subjects to date.

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