Crucell Announces Second Quarter 2009 Results
(Thomson Reuters ONE) - Total revenues and other operating income of ?78.7 million, anincrease 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 otheroperating income expected to grow 20% in constant currencies[2] ;operating profit for 2009 expected to improve significantly comparedto 2008; solid cash flow.Leiden, the Netherlands (August 11, 2009) - Dutch biopharmaceuticalcompany 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). Thesefinancial 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.Key Figures Second Quarter 2009:(? million, except net result per share) Second Quarter Six months ended June 302009 2008 Change 2009 2008 Changeunaudited unaudited Unaudited unaudited Total revenues and other operating 78.7 59.6 32% income 152.4 107.5 42% Operating 3.2 (9.0) - profit/(loss) 5.6 (12.1) - Net (1.8) (7.4) (75)% profit/(loss) (1.6) (15.9) (90)% Net result per share (0.03) (0.11) (76)% (basic) (0.02) (0.24) (90)% Cash & cash equiv.: - June 30, 2009 121.6 - Dec 31, 2008 171.0 - June 30, 2008 106.9Crucell's Chief Executive Officer Ronald Brus said:"We are very pleased to report positive operating profits for boththe second quarter and the first half of the year. Our marginsimproved significantly versus last year, despite increased costs dueto negative currency effects. We continue to be confident of ourbusiness prospects for the remainder of the year and thereforemaintain our guidance for 2009.Quinvaxem®-our most important paediatric vaccine-once again made animportant contribution to our revenues in the second quarter despitesome phasing of shipments into the second half of the year. Lookingforward, Quinvaxem® is well-positioned for the award of new tendersfor the period 2010-2012, the first tranche of which is expected tobe announced soon.During the second quarter we were also able to report significantprogress on our pipeline programs. Our recent endorsement by the MVI,the US Malaria Vaccine Initiative, reflects the growing recognitionthat Crucell is bringing innovative solutions to global health."Product and Business UpdateProduct Update:Product sales in the second quarter of 2009 amounted to ?66.4 millionand represent sales of paediatric vaccines (60%), travel and endemicvaccines (24%), and other products (16%).PaediatricSales of our paediatric vaccines, particularly driven by Quinvaxem®,continued to show solid growth in the second quarter 2009 despite avery strong first quarter and some phasing of shipments into thesecond 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 EndemicIn the second quarter of 2009, sales of our travel and endemicportfolio showed good growth. Our travel portfolio has seen limitedimpact from the economic crisis as we were able to compensate salesdeclines with good uptake of our hepatitis A vaccine Epaxal® in newterritories. In the second half of the year, in particular in thethird quarter, we expect weakening in the sales growth of our travelportfolio as reduced travel, particularly in the Nordic region, isanticipated. * 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).RespiratoryWe typically have no sales in respiratory products at the beginningof 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. * Malaria Vaccine based on AdVac®/PER.C6® Technologies: Crucell and its collaborator, the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), are conducting a Phase I trial in the USA for a recombinant malaria vaccine, Ad35-CS, based on the company's AdVac® technology and PER.C6® manufacturing platform. The vaccine candidate is made by inserting the gene for the circumsporozoite protein (CSP) from the Plasmodium falciparum malaria parasite into adenoviral vectors, which act as a 'vehicle' for vaccination delivery. The study is being carried out at two sites, Vanderbilt University in Nashville, Tennessee and Stanford University in Palo Alto, California. All four cohorts have been enrolled, and ongoing safety monitoring has revealed no significant safety concerns to date. Boost vaccinations for the fourth and final group of volunteers is underway. Preliminary examination of the blinded data from the first three cohorts indicates that the vaccine is immunogenic. Detailed analysis of the data awaits completion of the fourth cohort and unblinding of the data. * In July 2009 Crucell announced a new collaboration with US-based MVI and USAID MVDP to accelerate development of a promising new type of malaria vaccine. Through funding from the USAID MVDP, the partners will conduct studies to determine the effectiveness of Crucell's novel prime-boost vaccine approach against the malaria parasite P. falciparum. This approach uses Crucell's proprietary recombinant adenoviruses (a type of virus associated with the common cold and other mild respiratory infections), to deliver a malaria antigen to the immune system. Using Crucell's AdVac® technology with two different adenovirus vectors-Ad35 and Ad26-as delivery mechanisms, this approach seeks to elicit a protective immune response obtained from delivering the circumsporozoite protein (CSP). * Multivalent Filovirus (Ebola & Marburg) Vaccine based on AdVac®/PER.C6® Technologies: In October 2008 Crucell announced that it has secured a NIAID/NIH contract to advance the development of Ebola and Marburg vaccines, with the ultimate aim of developing a multivalent filovirus vaccine. The contract provides funding of up to $30 million, with additional options, which may be triggered at the discretion of the NIH, worth a further $40 million. The Phase I study of an adenovirus 5 (Ad5)-based Ebola vaccine that Crucell is developing in partnership with the Vaccine Research Center (VRC) of the NIAID/NIH, showed safety and immunogenicity at the doses evaluated. Based on these results, a second Phase I study of an Ebola and/or Marburg vaccine is anticipated. This will use alternative multivalent adenovirus vectors that are able to bypass pre-existing immunity against Ad5. * HIV Vaccine based on AdVac®/PER.C6® Technologies: The Investigational New Drug Application (IND) for Phase I of the trial with Harvard Medical School (supported by the NIH) was approved by the FDA in January 2008. In April 2008, Crucell announced the start of a Phase I clinical study of the novel recombinant HIV vaccine, using adenovirus serotype 26 (rAd26) as vector, that Crucell is jointly developing with the Beth Israel Deaconess Medical Center. The rAd26 vector is specifically designed to avoid the pre-existing immunity to the more commonly used adenovirus serotype 5 (Ad5). The Phase I clinical study is being conducted at the Brigham and Women's Hospital in Boston, USA and is focused on assessing the safety and immunogenicity of the vaccine. Enrollment is ongoing and involves 48 healthy volunteers. Dose escalation has proceeded without difficulty and the third cohort (10^11 vp/dose) has been fully enrolled. Boost vaccinations are ongoing. * Alternative Adenovirus Serotype Technologies: In November 2008, the leading scientific journal Nature published a study that demonstrated the value of Crucell's alternative adenovirus serotype technologies. Using Crucell's AdVac® vaccine technology and PER.C6® manufacturing technology, scientists engineered the rare adenovirus serotypes Ad26 and Ad35 to express a protein of SIV, the non-human primate equivalent of HIV. Rare serotype adenoviral vectors-such as rAd26 and rAd35 vectors- have been developed by Crucell to provide more potent prime-boost vaccine regimens. The study, which investigated the immunogenicity and protective efficacy of different vaccination regimes using rAd26, rAd35 or rAd5 as a prime, followed by a boost with rAd5, showed that in particular the rAd26/rAd5 combination elicits a strong T-cell immune response and provides protection against the HIV-like virus in non-human primate models. Crucell has several vaccines in development using alternative rAd26 and rAd35 vectors, including vaccines against malaria and tuberculosis. * Human Monoclonal Antibodies against a broad range of Influenza strains: Crucell's scientists discovered a set of human monoclonal antibodies that provides immediate protection and neutralizes the broadest range of H5N1 strains in preclinical models. When the most powerful of these antibodies was tested in preclinical models for prevention or treatment of a potentially lethal H5N1 infection, it was shown to prevent death and cure the disease. * In a preclinical study, Crucell's mAb CR6261 was compared with the anti-influenza drug oseltamivir (Tamiflu) in terms of its value for flu prevention and treatment. In December 2008, Crucell announced that its monoclonal antibody strongly outperformed the anti-influenza drug in these tests. The results were presented at IBC's 19th Annual International Conference on Antibody Engineering in San Diego, USA. * The flu strains tested included the 'bird flu' strain H5N1, which experts fear has the potential to cause a pandemic, and H1N1, which is similar to the flu virus strain H1N1, a descendant of the flu virus that caused the devastating pandemic in 1918. Importantly, the study showed that CR6261 provides immediate protection against the influenza virus, suggesting that it will be able to prevent disease spread. In contrast, oseltamivir was less efficacious and in some cases not effective at all. The characterization of the antibody was described in the online journal PLoS ONE on December 16, 2008. * Hepatitis C Antibody Combination: Crucell has obtained an exclusive license from Stanford University (Palo Alto, California) for the development of an antibody combination against the Hepatitis C virus. A large panel of fully human monoclonal antibodies against the Hepatitis C virus (HCV) is being evaluated by Crucell in a proof of concept phase. The monoclonal antibodies have been found to neutralize HCV across all genotypes tested and each recognizes a different part of the HCV surface protein. * Blood Coagulation Factor VL/C: Preclinical work on this program continues but conclusive proof of concept is not expected in the near future.Korean Production Facility:In October 2008 Crucell announced that an agreement was reached torelocate Crucell's Korean production facility from the Shingal sitein Yongin City, Korea to the Incheon Free Economic Zone, Korea.Construction activities at the new site started in December 2008 andare progressing well. Structural work on the site has been completedand electrical and mechanical engineering is progressing according toplan. First test runs are planned for the first half of 2010. The newfacility will enable the further growth and efficient production ofQuinvaxem® and Hepavax-Gene®. The investments in the new facility areexpected to total approximately ?50 million, with the majority ofspending in 2009.The Crucell Ambition:In 2008, The Crucell Ambition program was rolled out throughout theCompany and the management board met with more than 60% of Crucell'semployees from different parts of the organization. The CrucellAmbition is a strategic program focused on four priority areas. Theseareas are: Organization & People, Focus, Operational Excellence, andDeliver on Promises.The Operational Excellence 'Healthy Ambition' part of the program istargeting savings of ?30 million by the end of 2009 compared to the2007 cost base (excluding R&D). In the first half of 2009, a total of?10 million of net cost savings were achieved (Q1 2009 ?6 million; Q22009 ?4 million). Savings were predominantly achieved throughimproved yields, marketing and sales efficiency gain, and savings inoverhead.Manufacturing & Licensing Agreements: * Crucell today announces a non-exclusive PER.C6® research license agreement with Japan-based Momotaro-Gene Inc. for the production of an adenovirus-vectored gene therapy product for the treatment of prostate cancer, including the right to perform a first-in-man Phase I clinical trial program. Financial details of the agreement were not disclosed. [June 2009]Patents:The Company strengthened its patent position in the field of AdVac®technology by the acquisition of a portfolio of patents pertaining tothe manufacturing and downstream processing of adenoviruses fromIntrogen Therapeutics Inc.In Q2 2009 Crucell was granted a total of 21 new patents, includingpatents for: * Production of influenza virus for the production of vaccines using PER.C6® technology, in the USA (2 patents) * Production of viruses for the production of vaccines using PER.C6® technology, in the USA * Aspects of improved adenoviral AdVac® vectors and AdVac® technology, in Hong Kong * AdVac®-based malaria vaccines, in the USA * Production of antibody fragments using PER.C6® expression technology, in the USA * Improvements in PER.C6® expression technology, in Hong Kong * Elements of STAR® technology, in Israel * Targeting of adenovirus to specific cell types, in EuropePost Balance Sheet Events: * In July 2009 the PANFLUVAC consortium consisting of eight European research partners, including Crucell, completed the first stage of their phase I clinical trial in healthy volunteers, using a virosomal vaccine against A/H5N1 influenza. * Crucell today announces a non-exclusive PER.C6® research license agreement with Australian-based Patrys Ltd. for the production of several undisclosed antibodies. Financial details of the agreement were not disclosed. [July 2009]Financial Review Second Quarter 2009Total Revenues and Other Operating IncomeTotal revenues and other operating income amounted to ?78.7 millionfor the second quarter of 2009, an increase of 32% compared to thesame quarter of 2008. The increase was mainly driven by growth insales of our paediatric vaccines, in particular Quinvaxem®.Product sales in the second quarter of 2009 amounted to ?66.4 millionand represent sales of paediatric vaccines (60%), travel and endemicvaccines (24%), and other products (16%).License revenues were ?3.5 million in the second quarter, a decreaseof ?2.0 million compared to the same quarter of 2008, which includeda milestone payment for clinical development.Service fees for the quarter were ?2.5 million, compared to ?2.3million last year. Service fees represent revenues for productdevelopment activities performed under contracts with partners andlicensees.Other operating income was ?6.3 million for the quarter, compared to?3.4 million in the second quarter of 2008. The increase is relatedto the level of activity in our malaria and rabies programs.Cost of Goods SoldCost of goods sold for the second quarter of 2009 amounted to ?44.5million, ?42.2 million of which represents product costs and ?2.3million the cost of service and license activities.Gross margins were 39% in the quarter, compared to 36% in the secondquarter of 2008. Although our margins improved significantly versuslast year, this effect was negatively influenced by a stronger SwissFranc against the Euro and Korean Won against the US Dollar, whichincreased our reported costs of goods sold on a consolidated basis.We expect continued pressure on margins in the second half of theyear as a result of exchange rates.ExpensesTotal 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 second quarter were ?31.0 million,representing a ?1.8 million decrease compared to the same period in2008.R&D expenses for the second quarter amounted to ?15.9 million, whichrepresents a ?1.7 million decrease versus the second quarter of 2008.The decrease is due to the timing of program-related expenses.SG&A (M&S+G&A) expenses for the quarter were ?15.1 million, whichrepresents a ?0.1 million decrease versus the second quarter of 2008.Financial Expenses and TaxesNet financial expenses in the second quarter were ?2.7 million. Thiswas a result of lower interest income offset by negative currencyeffects on our balance sheet (net working capital) positions.The company recorded a ?2.2 million income tax charge in the secondquarter, mainly as a result of taxable profits in Korea and Sweden.The effective income tax rate in Korea for the year is approximately15%. However, the consolidated profit before tax is reduced by asignificant operating loss in the Netherlands as a result of R&Dexpenses. Therefore, the consolidated income tax is relatively highcompared to the profit before tax on a consolidated basis. TheCompany's tax charge for full year 2009 is expected to beapproximately ?12.0 million.Net ResultNet loss of ?1.8 million was reported in the second quarter of 2009versus a net loss of ?7.4 million in the same period of 2008. Netloss per share in the second quarter of 2009 is ?0.03, compared to anet loss per share of ?0.11 in the second quarter of 2008.Balance SheetTangible fixed assets amounted to ?156.9 million on June 30, 2009.Intangible assets amounted to ?72.9 million. This includes acquiredin-process research and development, developed technology, patentsand trademarks, and the value of customer and supplier relationships.Investments in associates and joint ventures amounted to ?9.4 millionand mainly represent investments in AdImmune and the PERCIVIA PER.C6®Development Center. Crucell's investment in Galapagos NV isclassified under available-for-sale investments.Total equity on June 30, 2009 amounted to ?463.2 million. A total of66.6 million ordinary shares were issued and outstanding on June 30,2009.Cash Flow and Cash PositionCash and cash equivalents decreased by ?15.3 million in the secondquarter to ?121.6 million. Cash used for operating activities in thesecond quarter, including working capital, amounted to ?6.9 million.Cash used in investing activities amounted to ?10.1 million,reflecting the capital investment in our new plant in Korea.Cash used for financing activities amounted to ?0.3 million,reflecting partial repayment of our loan in Korea, offset by proceedsfrom the issue of shares related to stock option exercises.Outlook 2009 reiterated[4] * Crucell expects its combined full-year 2009 total revenues and other operating income to grow 20% in constant currencies. * Operating profit for 2009 is expected to improve significantly compared to 2008. * Furthermore, the Company expects solid cash flow despite significant investments in the new facility being built in Korea. These investments are expected to total approximately ?50 million, with the majority of spending in 2009. * Crucell does not expect its results to be materially affected by the global recession.Phasing: We expect revenues throughout 2009 to be phased similarly tothose in 2008. The phasing of cash flow and working capital isexpected to significantly deteriorate in the first half of 2009,which is normal due to the seasonality of our business. We buildinventory in the first half of the year to sell our respiratory andtravel vaccine products in the second half of the year.Forward-looking statementsThis press release contains forward-looking statements that involveinherent risks and uncertainties. We have identified certainimportant factors that may cause actual results to differ materiallyfrom those contained in such forward-looking statements. Forinformation relating to these factors please refer to our Form 20-F,as filed with the US Securities and Exchange Commission on April 22,2009, in the section entitled 'Risk Factors'. The Company preparesits financial statements under International Financial ReportingStandards (IFRS).Conference Call and WebcastAt 14:00 Central European Time (CET), Crucell's management willconduct a conference call, which will also be webcast. To participatein the conference call, please call one of the following telephonenumbers 15 minutes prior to the event: +44 203 003 2666 for the UK; +1 646 843 4608 for the US; and +3120 794 8426 for the NetherlandsFollowing a presentation of the results, the lines will be opened fora question and answer session.The live audio webcast can be accessed via the homepage of Crucell'swebsite at www.crucell.com and will be archived and available forreplay following the event.About CrucellCrucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is aglobal biopharmaceutical company focused on research development,production and marketing of vaccines, proteins and antibodies thatprevent and/or treat infectious diseases. Its vaccines are sold inpublic and private markets worldwide. Crucell's core portfolioincludes a vaccine against hepatitis B, a fully-liquid vaccineagainst five important childhood diseases and a virosome-adjuvantedvaccine against influenza. Crucell also markets travel vaccines, suchas the only oral anti-typhoid vaccine, an oral cholera vaccine andthe only aluminum-free hepatitis A vaccine on the market. The Companyhas a broad development pipeline, with several product candidatesbased on its unique PER.C6® production technology. The Companylicenses its PER.C6® technology and other technologies to thebiopharmaceutical industry. Important partners and licensees includeDSM Biologics, sanofi-aventis, Novartis, Wyeth, GSK, CSL and Merck &Co. Crucell is headquartered in Leiden, the Netherlands, withsubsidiaries in Switzerland, Spain, Italy, Sweden, Korea and the USAThe Company employs over 1000 people. For more information, pleasevisit www.crucell.com.Financial Calendar3 November 2009 Q3 Results 20099 February 2010 Q4 Results 2009For further information please contact:Crucell N.V.Oya YavuzVice PresidentCorporate Communications & Investor RelationsTel. +31-(0)71-519 7064ir(at)crucell.comwww.crucell.comFinancial Half Year 2009 ReportThis report contains the half year financial report of Crucell N.V.('Crucell', or the 'Company', or the 'Group'), a company with limitedliability, headquartered in Leiden, the Netherlands. The principleactivities of the Company and its group companies are described inNote 1.1 to the condensed consolidated interim financial statements.The half year financial report for the six months ended June 30, 2009consists of the condensed consolidated interim financial statements,the half year management report and responsibility statement by theCompany's Board of Management. The information in this half yearfinancial report is unaudited.The condensed consolidated interim financial statements do notinclude all the information and disclosures required in the annualfinancial statements, and should be read in conjunction with theCompany's consolidated IFRS financial statements for the year endedDecember 31, 2008.Financial Review Half Year 2009Total Revenues and Other Operating IncomeTotal revenues and other operating income amounted to ?152.4 millionfor the first half of 2009, an increase of 42% compared to the sameperiod in 2008. The increase was mainly driven by growth in sales ofour paediatric vaccines, in particular Quinvaxem®.Product sales in the first half of 2009 amounted to ?129.6 millionand represent sales of paediatric vaccines (66%), travel and endemicvaccines (22%), and other products (12%).License revenues were ?8.0 million in the first half of 2009, adecrease of ?2.8 million compared to the same period of 2008, whichincluded milestone payments.Service fees for half year 2009 were ?5.4 million, compared to ?4.3million last year. Service fees represent revenues for productdevelopment activities performed under contract with partners andlicensees.Other operating income was ?9.5 million for the period, compared to?8.6 million in the first half of 2008.Cost of Goods SoldCost of goods sold for the first half of 2009 amounted to ?83.3million, ?78.4 million of which represents product costs and ?4.9million the cost of service and license activities.Gross margins were 42% in the first half year of 2009, compared to38% in the same period of 2008. Although our margins improvedsignificantly versus last year, this effect was negatively influencedby a stronger Swiss Franc against the Euro and Korean Won against theUS Dollar, which increased our reported costs of goods sold on aconsolidated basis. We expect continued pressure on margins in thesecond half of the year as a result of exchange rates.Operating ExpensesTotal expenses consist of research and development (R&D) expenses,marketing and sales (M&S) and general and administrative (G&A)expenses. Total expenses for half year 2009 were ?63.6 million,representing a ?5.3 million increase over the same period in 2008, asthe 2008 numbers contained a ?5.2 reversal of impairment.R&D expenses for the first half of 2009 amounted to ?31.2 million,which represents a ?2.2 million decrease versus the first half of2008.SG&A (M&S + G&A) expenses for the first half of 2009 were ?32.3million, which represents a ?2.4 million increase versus the firsthalf of 2008.Financial Expenses and TaxesNet financial expenses in the first half of 2009 were ?2.8 million.This was a result of lower interest income offset by negativecurrency effects on our balance sheet (net working capital)positions.The company recorded a ?4.6 million income tax charge in the firsthalf of 2009, mainly as a result of taxable profits in Korea andSweden. The effective income tax rate in Korea for the year is 15%.However, the consolidated profit before tax is reduced by asignificant operating loss in the Netherlands as a result of R&Dexpenses. Therefore, the consolidated income tax is relatively highcompared to the profit before tax on a consolidated basis. TheCompany's tax charge for full year 2009 is expected to beapproximately ?12.0 million.Net ResultNet loss of ?1.6 million was reported in the first half of 2009versus a net loss of ?15.9 million in the same period of 2008. Netloss per share in the first half of 2009 is ?0.02, compared to a netloss per share of ?0.24 in the first half of 2008.Balance SheetTangible fixed assets amounted to ?156.9 million on June 30, 2009.Intangible assets amounted to ?72.9 million. This includes acquiredin-process research and development, developed technology, patentsand trademarks, and the value of customer and supplier relationships.Investments in associates and joint ventures amounted to ?9.4 millionand mainly represent investments in AdImmune and the PERCIVIA PER.C6®Development Center. Crucell's investment in Galapagos NV isclassified under available-for-sale investments.Total equity on June 30, 2009 amounted to ?463.2 million. A total of66.6 million ordinary shares were issued and outstanding on June 30,2009.Cash Flow and Cash PositionCash and cash equivalents decreased by ?49.4 million in the firsthalf of 2009 to ?121.6 million. Cash used for operating activities inthe half year, including working capital, amounted to ?26.9 million.This reflects the seasonality of our business, in which we buildinventory in the first half of the year to sell our products in thesecond half of the year.Cash used for investing activities amounted to ?17.5 million,reflecting the capital investment in our new plant in Korea.Cash used for financing activities amounted to ?4.8 million,reflecting partial repayment of our loan in Korea, offset by proceedsfrom the issue of shares related to stock option exercises.Risk paragraphA summary of our principal risks is provided below. This informationis also presented under the section 'risk factors' in our AnnualReport and Form 20-F for the financial year 2008 as filed with the USSecurities and Exchange Commission (SEC) on April 22, 2009 and theNetherlands Authority for Financial Markets (Autoriteit FinanciëleMarkten or AFM) on April 23, 2009. We have classified these riskfactors in accordance with the categories identified in the COSO[5]model. * Strategic risks: Concentration of sales; Use of our technologies by our partners or licensees; and Competition & pricing pressures * Operational risks: Product development and clinical trials; Interrupted product supply; Regulatory approval; Intellectual property; Product liability exposure; Qualified personnel; Hazardous biological materials; and Competition laws. * Financial risks: Substantial use of capital; Weakness in the global economy; Foreign currency risk; and Taxation. * Compliance and other risks: Ethical legal and social issues related to the use of genetic technology; Protective measures included in articles of association; Not able to exercise pre-emption rights; Difficulties protecting interests in a Dutch limited liability company; and Share price volatilityPrincipal risks and uncertainties for the Group as at Q2 remainunchanged compared to those applicable as at the end of 2008 exceptfor those updated below.Weakness global economyThe weakness of the global economy is a challenge for many companies.The ongoing financial crises adversely affected businesses in manyindustries and geographical areas all over the world. Except for ourtravel portfolio, we are relatively unaffected by the financialcrisis. We note that international travel is reduced by the financialcrisis as well as the global pandemic, which will in turn negativelyaffect the number of travel vaccinations.We expect the effects on our travel portfolio to have a limitedeffect on our overall profitability and liquidity. We do not expectthat the weakness of the global economy will significantly impact ourliquidity or our ability to derive revenues from our operations. Wedo note that there can be no assurance that our liquidity will notbe affected by recent and possible future changes in global financialmarkets and global economic conditions.Interrupted product supply as a result of a worldwide flu pandemicThere is an increased perception in the market that companies may notbe able to acquire certain resources as these may become limited insupply as the worldwide flu pandemic evolves. The impact on ourantigen sourcing is assessed to be limited in the coming six months.Foreign currency riskDuring the first half of 2009, our margins were negatively affectedby currency fluctuations; the US Dollar decreased in value comparedto the Euro. As per June 30, 2009 the EUR/ USD rate is 1.40, which isbelow our guidance rate of EUR/ USD 1.35. Compared to 2008, the SwissFranc strengthened against the Euro, which had a negative currencyeffect on our results as we produce Inflexal®, Epaxal® and Vivotif®at our Swiss facilities. The Korean Won experienced significantvolatility over the past year compared to the US Dollar, which isrelevant as we produce Quinvaxem® and Hepavax-Gene® in our Koreanfacilities. In the remainder of 2009, our results will be furtherimpacted by currency movements.Related partiesThe Group has related party transactions and balances with jointventure partners, associates and directors and executive officers.For a detailed description of these transactions we refer to note 10in the notes to the condensed consolidated interim financialstatements.Director's StatementCrucell's Management Board, as required by section 5.25d paragraph 2cof the Dutch Act on Financial Supervision (Wet op het FinancieelToezicht), confirms that to the best of their knowledge: * The condensed consolidated interim financial statements for the period ended June 30, 2009 give a true and fair view of the assets, liabilities, financial position and the profit or loss of the Group; * The Directors' report gives a true and fair view of the Group's position as per June 30, 2009, the developments during the first six months of 2009 and of the expected developments, whereby, unless there are important reasons for not doing so, particular attention has been devoted to the investments and the circumstances on which the development of turnover and profitability depends.August 11, 2009,Ronald BrusLeon KruimerCees de JongJaap GoudsmitCondensed consolidated interim financial statementsThe following statements are included in the PDF file of this pressrelease: * Condensed Consolidated Statements of Income * Condensed Consolidated Statements of Comprehensive Income * Condensed Consolidated Statements of Financial Position * Condensed Consolidated Statements of Changes in Equity * Condensed Consolidated Statements of Cash FlowsNotes to the condensed consolidated interim financial statements[All amounts are in thousands of Euro, unless otherwise stated]1 General1.1 Corporate informationCrucell N.V. ('Crucell', or the 'Company', or the 'Group') isincorporated and domiciled in Leiden, the Netherlands. Its shares arepublicly traded on NYSE Euronext Amsterdam (CRXL), and SWX SwissExchange Zurich (CRX). Its American Depositary Shares (ADSs) arepublicly traded on NASDAQ New York (CRXL). Crucell and itssubsidiaries together constitute the Crucell Group, or the 'Group'.The Company has subsidiaries in the Netherlands, Switzerland, Spain,Italy, Sweden, Korea and the US. Crucell employed 1,168 people atJune 30, 2009 (June 30, 2008: 1,148).Its vaccines are sold in public and private markets worldwide.Crucell's core portfolio includes a vaccine against hepatitis B, afully-liquid vaccine against five important childhood diseases and avirosome-adjuvanted vaccine against influenza. Crucell also marketstravel vaccines, such as the only oral anti-typhoid vaccine, an oralcholera vaccine and the only aluminum-free hepatitis A vaccine on themarket. The Company has a broad development pipeline, with severalproduct candidates based on its unique PER.C6® production technology.The Company licenses its PER.C6® technology and other technologies tothe biopharmaceutical industry.There have been no changes to the organizational structure in thefirst half of 2009.1.2 Basis of preparationThis condensed consolidated interim financial statements for the sixmonths ended June 30, 2009 has been prepared in accordance with IAS34, 'Interim financial reporting'. The condensed consolidated interimfinancial statements should be read in conjunction with the financialstatements for the year ended December 31, 2008, which have beenprepared in accordance with International Financial ReportingStandards (IFRS) as adopted by the European Union. These consolidatedinterim financial statements have not been audited or reviewed.Accounting policiesExcept as described below, the accounting policies applied areconsistent with those applied in the financial statements for theyear ended December 31, 2008, as described in those financialstatements.As of 1 January 2009, IAS 1 (revised) 'Presentation of financialstatements' became effective. The revised standard requires all'non-owner changes in equity' to be shown in a performance statement.Entities can choose whether to present one performance statement (thestatement of comprehensive income) or two statements (the incomestatement and statement of comprehensive income). The group electedto present two statements: a statement of income and a statement ofcomprehensive income. The revised standard also introduces a numberof terminology changes, including revised titles for the statementsincluded in the financial statements.Not all standards, amendments to standards and interpretations,which are mandatory for the first time for the financial yearbeginning 1 January 2009 have been listed above as they are notexpected to be relevant for the Group or do not vary from our currentaccounting policies.1.3 Estimates and judgmentsThe preparation of the interim financial statements requiresManagement to make judgments, estimates and assumptions that affectthe application of accounting policies and the reported amounts ofassets, liabilities, income and expenses. Actual results may differfrom these estimates.Estimates and underlying assumptions are reviewed on an ongoingbasis. Revisions to accounting estimates are recognized in the periodin which the estimate is revised and in any future periods affected.In particular, information about significant areas of estimationuncertainty and use of critical judgments in applying accountingpolicies that have the most significant effect on the amountrecognized in the financial statements relates to: * Revenue recognition * Valuation of deferred tax assets and liabilities * Impairment reviews of property, plant and equipment, intangible assets and goodwill * Valuation of defined benefit plans * Recognition of provisions for litigations and claimsThe above uncertainties are described in detail in the notes to thefinancial statements of our Annual Report and Form 20-F for thefinancial year 2008 as filed with the AFM on April 23, 2009.There are no changes in the nature of uncertainties, changes inestimates of amounts reported in prior interim periods or otherchanges that should be disclosed in these notes.1.4 Change in accounting policyEffective as of January 1, 2008 the Group adopted IFRIC 14, 'IAS 19 -The limit on a defined benefit asset, minimum funding requirementsand their interactions'. The interpretation provides guidance onassessing the limit of the surplus in a defined benefit pension fundthat can be recognized as an asset. It also explains how the pensionasset or liability may be affected by a statutory or contractualminimum funding requirement. The pension fund in Switzerland has aminimum funding requirement with economic benefits from overfundingbeing available as a reduction of future contributions. Theapplication of the interpretation resulted in an increase in theassets recorded on the Group's balance sheet and a correspondingincrease in the Group's equity.The Group restated the comparative information for the first halfyear of 2008 to reflect the effects resulting from the adoption ofIFRIC 14. The impact on the comparative information for the firsthalf year of 2008 on the consolidated statement of income is asfollows:In thousands of Euro First half 2008 Impact IFRIC 14 First half 2008 - before - adoptedIncome Statement IFRIC 14 IFRIC 14Gross margin 37,604 - 37,604Operating expenses (59,542) 1,284 (58,258)Operating profit / (13,377) 1,284 (12,093)(loss)Profit / (loss) (15,653) 1,284 (14,369)before taxIncome Tax (1,239) (276) (1,515)Profit / (loss) for (16,892) 1,008 (15,884)the periodThe change in accounting policy does not affect the Group's balancesheet as at December 31, 2008 since the change in accounting policyhas already been reflected in the 2008 financial statements for theyear end December 31, 2008.2 SeasonalityThe sales of the Group are exposed to seasonal variations, and mostof our sales are made in the second half of the year. This isspecifically the case for influenza vaccines, as vaccination programsmainly take place in the second half of the year. Furthermore, thetravel vaccine portfolio sales are subject to seasonal travelpatterns.3 SegmentationThe Group adopted IFRS 8 'Operating Segments', which replaces IAS 14,'Segment reporting', as of January 1, 2007. The Group identified theManagement Board as the 'chief operating decision maker'. TheManagement Board reviews the consolidated operating results regularlyto make decisions about resources and to assess overall performance.This led to the identification of one reportable segment, whichcomprises the development, production and marketing of products thatcombat infectious diseases.3.1 Information about major productsThe breakdown of the Group's revenues from its product sales is asfollows:In thousands of Euro First half 2009 First half 2008Paediatric vaccines 85,253 43,224Respiratory vaccines - -Travel vaccines 28,131 27,588Other vaccines 6,353 3,937Proteins and other business 9,829 9,161 129,566 83,9104 Income taxesIn the first half of 2009, the tax charge increased by ? 3,058 or202% to ? 4,573 compared to ? 1,515 in the same period prior year.The increase in tax is mainly caused by current tax charges of ?5,988 as a result of taxable income in Sweden, Korea, Spain and theUSA.During the first 6 months of 2009 the Group had an effective tax rateof 155.9%. This relatively high tax rate is due to the particularstructure of our organization. In most of our subsidiaries we realizetaxable profits, however, in the Netherlands, we realized a taxableloss for which no deferred tax asset has been recognized. As aresult, our tax charges are divided by a relatively low profit basewhich leads to an effective tax rate of 155.9%.We expect our effective tax rate to remain high until we benefit fromthe tax exemptions in Korea starting in 2011 or until we are able tocapitalize deferred taxes in the Netherlands.In the first half of 2009, we realized profits in subsidiaries thatare subject to taxation. The profits in these countries were partlyoffset by losses incurred in jurisdictions (mainly the Netherlands)for which no deferred tax assets have been recognized.5 Property, plant and equipmentIn thousands of EuroNet book value PPE, January 1, 2009 151,206Additions 17,679Disposals (68)Depreciation charge for the year (10,445)Effect of movements in exchange rates (1,513)Net book value PPE, June 30, 2009 156,859In the first half of 2009 the company invested a total of ? 17,679 inproperty, plant and equipment. These investments mainly related toour new Korean production facility; investments in our facilities inBern (Switzerland), which will improve current production processesand allow in-house production of materials currently acquired fromthird parties; and investments in our new filling line in Madrid(Spain).The remaining contractual commitments for property, plant andequipment amount to ? 28,740 (December 31, 2008: ? 20,380). Thesecommitments mainly relate to the new Korean production facility inthe Incheon, Free Economic Zone, Korea.No impairments or reversals of impairments were recognized in thefirst half of 2009.6 InventoriesIn thousands of Euro June 30, 2009 December 31, 2008Raw materials and consumables 35,400 13,286Work in progress 73,082 61,980Finished products 16,323 16,581 124,805 91,847We build up inventory in the first half of the year for ourpaediatric and respiratory travel vaccine products, in anticipationof future sales.In order to be able to meet the demand from the market (e.g. in caseof outbreak of a disease) the Group stocks certain inventories to alevel such that they might not be utilized in one year. Provisionsare recognized for obsolete inventory.7 Issued share capital and reservesIn thousands of EuroOrdinary shares Number of Issued Shareissued and fully paid Shares capital PremiumAt January 1, 2008 65,349 15,685 735,578Issue of shares 327 77 1,861Costs share-based paymenttransactions - - 2,388At June 30, 2008 65,676 15,762 739,827At January 1, 2009 65,833 15,800 743,746Issue of shares 728 175 6,304Costs share-based payment transactions - - 4,191At June 30, 2009 66,561 15,975 754,241No dividends were distributed during the first half of 2009.In the first half of 2009 a total number of 700,290 options wereexercised, which resulted in an increase of issued capital by ? 168.In the first half of 2009 a total number of 27,500 shares were issuedto members of the Supervisory Board, which resulted in an increase ofissued capital by ? 7. Total cash received by the Group on theseshare issuances amounts to ? 6,304. The costs of ? 4,191 representthe non-cash period costs for the share-based payment transactions.8 Share-based payment plansThe Group maintains stock option plans whereby the Remunerationcommittee of the Supervisory Board may grant options to employees,directors and members of the Supervisory Board. The compensationexpenses included in operating expenses for those plans during thefirst half of 2009 were ? 3,886 (first half year 2008: ? 2,301).In the first half of 2009 a total number of 700,290 options wereexercised, which resulted in an increase of issued capital by ? 168.9 Short-term and long-term financial liabilitiesIn thousands of Euro June 30, December 31, 2008 2009Mortgage loan 16,279 16,461Equipment lease 19,142 20,526Comprehensive credit limit Berna Biotech 13,877 20,855Korea Corp.Loan Berna Biotech Korea Corp. - 2,909Other financial liabilities 316 -Total financial liabilities 49,614 60,751Loan Berna Biotech Korea Corp.As at December 31, 2008, Berna Biotech Korea Corp. had an unsecuredEuro loan at an interest rate of 5.45%. The original maturity dateof the loan was August 1, 2010, but the loan was repaid in full onFebruary 2, 2009.Comprehensive credit limit Berna Biotech Korea Corp.In 2008, Berna Biotech Korea Corp. entered into two short-termcomprehensive credit limit transaction agreements for KRW 10 billionand KRW 30 billion. Originally these agreements ended on January 28,2009 and May 31, 2009 respectively. In 2009, the period for the 30billion agreement was extended to May 31, 2010. On June 30, 2009 anamount of KRW 25 billion (? 13,877) was drawn under this agreement.Mortgage loan facility Berna Biotech Korea Corp.On March 26, 2009, the Group entered into a mortgage loan facility inKorea for an amount of KRW 50 billion (? 27,704) with a third partybank to partly finance the investments in the new Korean facility in2009. The loan has a duration of 60 months and has a variableinterest rate that is based on a Korean interest index plus amark-up. As at June 30, 2009, no funds were drawn from the mortgagefacility. Crucell NV provided the third party bank with a guarantyamounting to KRW 50 billion plus interest and other costs.10 Related parties10.1 GeneralThe Group has related party transactions and balances with jointventure partners, associates and directors and executive officers.All transactions with related parties were carried out under normalmarket conditions (arm's length principle). There are no relatedparty transactions outside the normal course of business. There wereno material changes in the nature, scale or scope of related partytransactions in the first half of 2009 compared with those disclosedin the Financial Statements for the year ended December 31, 2008.10.2 Remuneration Management Board and Supervisory BoardFor detailed descriptions of the remuneration structure for theMembers of the Supervisory and Management Board, reference is made tothe 'Remuneration policy for Management Board and Supervisory Board'as included in the Corporate Governance section of the 2008 AnnualReport and Form 20-F.RemunerationIn 2009, the base salary levels of the Management Board wereincreased by 3% to 5%. Each year, the Supervisory Board considerswhether base salary levels should be adjusted according to externaland internal business factors. Except for minor indexations, nochanges to the remuneration package of the members of the Managementand Supervisory Board have been processed. The Company deems theremuneration over 2008 to be representative for the 6-month periodended June 30, 2009. Consequently, we refer to note 5.23 'relatedparties' of the 2008 Annual Report and Form 20-F.Exercising of options; purchase of sharesOn February 18, 2009 250,000 options with an exercise price of ? 9.40were exercised by the CEO and 85,000 shares were purchased. Inaddition, 85,000 options with an exercise price of ? 9.40 wereexercised by the CSO and 10,000 shares were purchased. Theseexercises were due to expiry of the options. There were no otherexercises of share options held by members of the Management Board orSupervisory Board.Long-term incentive planOn January 1, 2009, as part of the long-term incentive plan, a totalnumber of 99,703 conditional options were granted to members of theManagement Board.Share grants to Supervisory BoardOn February 5, 2009, a total of 27,500 shares were granted to membersof the Supervisory Board.11 LitigationsIn the first half of 2009, there were no material changes to theGroup's litigations from those disclosed in the Financial Statementsfor the year ended December 31, 2009 other than those disclosedbelow.In 2008, a competitor of Crucell filed a protest against the award ofa government grant to Crucell for the development and manufacture ofa vaccine against the Ebola and Marburg virus. The complaint wasfiled against the US Government but Crucell voluntarily joined theproceedings to defend the award. Following a dismissal of the protestby the US Government Accountability Office (GAO), the competitorfiled an appeal with the United States Court of Appeals for theFederal Circuit. In the second quarter of 2009, this appeal by thecompetitor was also dismissed.12 Contingent liabilities or contingent assetsIn the first half of 2009, there were no material changes to theGroup's commitments and contingent liabilities from those disclosedin the Financial Statements for the year ended December 31, 2009other than those disclosed below.As part of the overall working capital management efforts, the Groupagreed with Novartis to extend payment terms on the supply ofQuinvaxem® antigens. We provided Novartis with collateral on ourSwiss premises. This amount was increased to CHF 45,000 (? 29,507)compared to CHF 34,000 at year-end 2008
Datum: 11.08.2009 - 07:44 Uhr
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