Crucell Announces Third Quarter 2008 Results

Crucell achieves profitability in Q3 2008. Crucell announces third quarter 2008 results with net income of EUR 12.3 million. Total revenue and other operating income increased by 31% to EUR 82.1 million compared to the same quarter last year. Gross margin in the third quarter mproved to 50% (from 36% last year). 2008 full year guidance for total revenue and other operating income growth increased to 25-30% in constant currencies (from 20%).

Leiden, The Netherlands (November 11, 2008) – Dutch biopharma company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) today announced its financial results for the third quarter of 2008, based on International Financial Reporting Standards (IFRS). These financial results are unaudited.

Highlights:

   * Crucell achieves its first ever quarterly profit; a net income of     EUR 12.3 million, compared to a net loss of EUR 4.5 million in the same     period of 2007. This amounted to EUR 0.19 net profit per share in     the third quarter, compared to a net loss per share of EUR 0.07 in     the third quarter of 2007.   * Crucell received additional contracts of $140 million for     supplies of Quinvaxem(R) and Hepavax-Gene(R) for the period 2008 -     2009, bringing the total for the period 2007 - 2009 to $0.5     billion.   * Crucell presented positive preliminary results of the Phase II     clinical study of its rabies monoclonal antibody combination in     the United States. This advance triggered another milestone     payment from collaboration partner sanofi pasteur in the third     quarter of 2008.   * Crucell also received a milestone payment from sanofi pasteur for     the advancement of the seasonal influenza vaccine (FluCell)     developed by sanofi pasteur, using Crucell's PER.C6(R) technology.   * Crucell and Aeras, the Global TB Vaccine Foundation, announced     two important advances in its collaborative tuberculosis (TB)     vaccine program. The jointly developed TB vaccine candidate     AERAS-402/Crucell Ad35 has entered a new Phase I clinical trial     in Kenya as well as a first Phase II safety study, conducted in     Cape Town, South Africa.   * Crucell received additional funding from the National Institute     of Allergy and Infectious Diseases (NIAID), part of the U.S.     National Institutes of Health (NIH), aimed at the development of     vaccines targeting both Ebola and Marburg viruses. The contract     provides funding of up to $30 million, with additional options     worth a further $40 million.   * Crucell signed several new license agreements including an     exclusive, commercial license agreement with Talecris     Biotherapeutics for an undisclosed and specific protein to be     produced using the PER.C6(R) cell line.   * DSM and Crucell announced another key achievement for PER.C6(R)     technology with a scale up of high-titer fed-batch process to 250     Liters.   * Crucell and Lonza entered into a co-exclusive manufacturing,     sales and distribution agreement related to the PERMEXCIS(TM)     cell culture medium developed by Crucell for PER.C6(R) cells. 

Financial Highlights:

   * Combined total revenue and other operating income for the quarter     of EUR 82.1 million compared to EUR 62.6 in the same quarter of 2007.     The increase of 31% (38% in constant currencies) was largely     driven by strong sales of paediatric vaccines as well as license     income.   * Increase of license revenues mainly driven by milestone payments     for the results of the Phase II clinical study of Crucell's     rabies monoclonal antibody combination and for sanofi pasteur's     seasonal influenza vaccine FluCell.   * Gross margins of 50% compared to 36% in the third quarter of     2007. Gross margins in the third quarter of this year are     positively influenced by a significant increase in license     revenue, sales of our flu product     (Inflexal(R) V) and better production yields, as well as improved     plant utilization due to higher volumes.   * Net income in the third quarter of 2008 of EUR 12.3 million versus a     net loss of EUR 4.5 million in the same quarter of 2007.   * Cash and cash equivalents at the end of the third quarter     amounted to EUR 103.9 million versus EUR 163.2 million at year-end     2007. Deterioration of cash flow and working capital in the first     three quarters of 2008 was expected and is due to the seasonality     of our business.   * Net cash used in operating activities in the third quarter of     2008 was EUR 9.9 million, caused by a EUR 26 million net increase in     working capital, compared to net cash used in operating     activities of EUR 5.5 million in the same quarter of 2007.   * In anticipation of the expected further growth of Quinvaxem(R) in     2009, we will continue to build stock of Quinvaxem(R) in the fourth     quarter of 2008. 

 Key Figures Q3 2008: (EUR  million, except net result per share)      Third Quarter                                 Nine months ended                                             Sept 30 2008      2007   Change                                 2007   Change                                             2008                            Total revenues                                 and                           other operating 82.1    62.6     31%          income        189.6       137.2  38% 12.3   (4.5)     -          Net result      (4.6)       (41.2) -                           Net result per                                share 0.19  (0.07)     -           (basic)        (0.07)      (0.63) -                         Cash & cash equiv.:                           - Sept 30, 2008         103.9                           - Dec 31, 2007          163.2 

Crucell’s Chief Executive Officer Ronald Brus said:

“These results showing profitability represent a great achievement in the history of Crucell.

Our financial strength as well as the sustainable business we operate in, enables us to pursue our ambition to increase the number of people we can protect from infectious diseases. I am very pleased to be able to raise our revenue forecast for 2008 on the back of these strong results.”

Product and Business Update

Product Update:

Product sales for the third quarter of 2008 amounted to EUR 65.6 million and represent sales of paediatric vaccines (44%), travel and endemic vaccines (16%), respiratory vaccines (30%) and other products (10%).

Paediatric

In the third quarter of 2008 we saw strong growth of our paediatric vaccines, mainly driven by Quinvaxem(R).

   * Quinvaxem(R): Fully liquid pentavalent vaccine against five     important childhood diseases.   * Hepavax-Gene(R): Recombinant vaccine against hepatitis B.   * Epaxal(R) Junior: Paediatric dose (0.25mL) of Epaxal(R) - the only     aluminum-free vaccine for children against hepatitis A. The     product is currently under registration in selected countries     worldwide. Sales in South America are progressing well and a     European launch is being planned.   * MoRu-Viraten(R): Vaccine for protection against measles and rubella     (for all age groups). 

Travel and Endemic

The third quarter of 2008 showed solid growth of our travel and endemic portfolio. We continue to see significant untapped demand and potential for geographical expansion of our travel portfolio.

   * Epaxal(R): The only aluminium-free vaccine against hepatitis A.   * Vivotif(R): The only oral vaccine against typhoid fever.   * Dukoral(R): The only oral vaccine against diarrhea caused by     cholera and ETEC (enterotoxigenic E.coli). 

Respiratory

The third quarter of 2008 showed solid growth, compared to the same quarter of 2007 of our flu vaccine Inflexal(R) V.

   * Inflexal(R) 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 the flu     products in the second half of the year. 

Pipeline Update:

   * Flavimun(R) - Live Attenuated Yellow Fever Vaccine: Crucell's     management expects the registration submission of the Yellow     Fever vaccine in Switzerland and Germany in the first quarter of     2009. 

   * Influenza - Seasonal Flu Vaccine (FluCell collaboration with     sanofi pasteur): The seasonal influenza vaccine developed by     Crucell's partner sanofi pasteur, using PER.C6(R) technology. Phase     II testing of the cell based influenza vaccine was initiated in     the U.S. in November 2007. In the third quarter 2008, Crucell     received a milestone payment from sanofi pasteur for the progress     of the Phase II trials involving healthy adult volunteers in the     U.S. The trials focus on the safety profile and immunogenicity of     the cell-based vaccine. 

   * Rabies Human Monoclonal Antibody Combination: Crucell's rabies     monoclonal antibody combination, developed in close collaboration     with sanofi pasteur using Crucell's PER.C6(R) manufacturing     technology. In 2008 Crucell initiated two Phase II studies in the     U.S. and in 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.     In the collaboration with sanofi pasteur Crucell will be     responsible for the manufacturing of the final 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.     Positive preliminary  results of  our Phase  II U.S.  study  were     presented at the 19th annual  RITA meeting in Atlanta on  October     1, 2008.  There  was no  serious  adverse event  reported.  These     results triggered another milestone payment from sanofi  pasteur,     at the end of September, as part of the total eligible amount  of     EUR 66.5 million.  This  antibody  combination  is  to  be  used  in     combination with a rabies  vaccine for post-exposure  prophylaxis     (PEP) against this fatal disease. 

   * Tuberculosis Vaccine based on AdVac(R)/PER.C6(R) Technologies:  The     development of the candidate vaccine AERAS-402/Ad35 is being     carried out in collaboration with the Aeras Global TB Vaccine     Foundation.     Phase I:   * U.S. Phase I trial in healthy adults not previously immunized     with Bacille Calmette-Guerin (BCG), the traditional TB vaccine,     has been completed and has demonstrated that AERAS-402/Ad35 is     safe in this population.   * Preliminary 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.   * A third phase I study in healthy adults in St. Louis, U.S.     focuses on the immunogenicity and safety of two AERAS-402/Ad35     boost doses administered at three to six month intervals after     BCG priming in healthy adults.   * In October, a Phase I clinical trial of the jointly developed TB     vaccine was started in Kenya. The study will be conducted by the     Walter Reed Project-Kenya at Kombewa, near Kisumu, Western     Kenya. Its main objective will be to test the safety of the     candidate vaccine in healthy adults, all of whom have been     previously vaccinated with the BCG vaccine and a subset of whom     show evidence of exposure to TB.     Phase II:   * In October enrollment for the first Phase II study of     AERAS-402/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     Institute. The candidate will be tested in 82 adults who have had     active TB. 

   * Malaria Vaccine based on AdVac(R)/PER.C6(R) Technologies: Crucell and     its partner, the National Institute of Allergy and Infectious     Diseases (NIAID), part of the National Institutes of Health     (NIH), are conducting a Phase I trial in the U.S. The study is     being carried out on two sites, VanderBilt and Stanford     University. The first three cohorts have been enrolled and     ongoing safety monitoring has revealed no significant safety     concerns to date, but formal analysis awaits unblinding of the     data. Enrollment for the fourth and final group of volunteers is     still ongoing and initial findings of this Phase I trial are     expected in the first quarter of 2009. 

   * Multivalent Filovirus Vaccine (Ebola & Marburg) based on     AdVac(R)/PER.C6(R) Technologies: In October Crucell announced that it     has secured a NIAID/NIH contract aimed at advancing the     development of Ebola and Marburg vaccines, ultimately leading to     a multivalent filovirus vaccine. The contract provides funding of     up to $30 million, with additional options that may be triggered     at the discretion of the NIH worth a further $40 million. The     Phase I study of an Ad5 based Ebola vaccine, being developed 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 adenovirus vectors which are able to by-pass     pre-existing immunity against Ad5. 

   * HIV Vaccine based on AdVac(R)/PER.C6(R) 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, 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, U.S. and     is focused on assessing the safety and immunogenicity of the     vaccine. Enrollment is ongoing and involves 48 healthy     volunteers. 

   * This Week Nature Published a Study which Demonstrates the Value     of Crucell's Alternative Adenovirus Serotype Technologies: Using     Crucell's AdVac(R) vaccine- and PER.C6(R) 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 regimes. 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.   * H5N1 - Human Monoclonal Antibodies against Flu: 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 tested in     pre-clinical models for prophylactic or therapy of a potentially     lethal H5N1 infection, this antibody was shown to prevent death     and cure the disease. Currently a study to demonstrate the     effectiveness of this antibody compared to Oseltamivir is being     carried out.   * Blood Coagulation Factor VL/C: Preclinical work on this program     continues but conclusive proof of concept is not expected in the     near future. 

The Crucell Ambition:

In the last few months The Crucell Ambition program has been rolled out throughout the whole organization and the executive board has met with more than 50% of Crucell’s employees from different parts of the organization. The Crucell Ambition program encompasses coordinated efforts in four priority areas, which have been carefully defined after a thorough review of Crucell’s operations, objectives and potential. These are:

1. ORGANIZATION & PEOPLE. Development of our organization and our people is the foundation for achieving our ambition as a company. Multiple measures are being implemented to achieve this.

2. FOCUS. Crucell is clearly focused on its mission to protect lives from infectious diseases by bringing innovation to global health. We are building on our strengths by prioritizing those programs that are in line with this ambition and that contribute to our strategic and financial objectives.

3. OPERATIONAL EXCELLENCE. Crucell launched its ‘Healthy Ambition’ operational excellence program at the start of 2008 and is now implementing the validated plans drawn up in the first half of the year. By streamlining and optimizing our business processes, the program is expected to generate cost reductions of EUR 30 million by the end of 2009.

4. DELIVER ON PROMISES. Crucell has set its sights high and is firmly committed to delivering on its ambitious promises. Evidence-based target setting and a company-wide emphasis on organization and people, focus and operational excellence will enable us to do so.

PER.C6(R) technology platform:

   * DSM Biologics and Crucell announced that the high-titer fed-batch     process developed at the PERCIVIA PER.C6(R) Development Center,     their joint venture in Cambridge, U.S. was recently scaled up to     250 Liters by DSM Biologics scientists at their GMP facility in     Groningen, The Netherlands. They successfully achieved 8 grams     per liter for an IgG expressed by PER.C6(R) cells using chemically     defined cell culture medium in a SUB (single-use bioreactor).     This result  is  further  confirmation that  PER.C6(R)  cell  lines     provide  a   reliable,   versatile  and   commercially   feasible     production  platform  for   manufacturing  large  quantities   of     therapeutic proteins easily  and affordably.  This latest  result     also demonstrates the  reliable performance of  the PER.C6(R)  cell     line under  conventional fed-batch  production conditions,  which     are widely  used  in  the industry.  Earlier  this  year  Crucell     reported record-breaking protein yields of  27 grams per liter  -     biomass corrected - using DSM's innovative XD(TM) technology. 

Manufacturing & Licensing Agreements:

   * Lonza and Crucell entered into a co-exclusive manufacturing,     sales and distribution agreement related to the PERMEXCIS(TM)     cell culture medium developed by Crucell for PER.C6(R) cells. Under     this agreement, Lonza will manufacture the medium, and in     addition will market and sell it on a global basis. Financial     details of the agreement were not disclosed. [September 2008]     The PERMEXCIS(TM)  medium is  a chemically  defined cell  culture     medium that does not contain human- or animal-derived components.     PERMEXCIS(TM) medium was developed for the cultivation of PER.C6(R)     cells  and  has  been  designed   for  use  in  the   large-scale     manufacture of  biopharmaceutical products,  including  vaccines.     This novel medium has proven, in a comparison study performed  by     Crucell, to  provide  higher  viral  vaccine  product  yields  in     PER.C6(R) based manufacturing  processes than some  of the  current     available media for PER.C6(R) cells on the market.   * Crucell announced that it has signed an exclusive, commercial     license agreement with North Carolina-based Talecris     Biotherapeutics for an undisclosed and specific protein to be     produced using a PER.C6(R) cell line. Crucell received an upfront     payment of $2.5 million following the execution of the agreement     and will be eligible for milestone payments of approximately $30     million across multiple indications. Further financial details of     the agreement were not disclosed. [September 2008]   * Crucell announced a non-exclusive PER.C6(R) research license     agreement with Birmingham-based Vaxin Inc. for their research and     development of a vaccine for the prevention/treatment of     Alzheimer's disease for humans as well as for an additional     undisclosed field. Financial details of the agreement were not     disclosed. [September 2008] 

Patents:

In Q3 2008 Crucell received a total of 50 granted patents, including patents for:

   * Methods for obtaining STAR(R) elements, in Israel   * Stable adenoviral AdVac(R) vectors, in Europe   * Improved methods for the production of viruses using PER.C6(R)     cells, in India   * Adenoviral vector based malaria vaccines, in New Zealand   * Technology for the production of antibody mixtures using PER.C6(R)     cells, in the U.S. and New Zealand   * Improvements in PER.C6(R) expression technology, in China   * Improved methods for quantifying influenza antigens, in Europe   * Technology for producing measles virus vectors, in the U.S. 

Post Balance Sheet Events:

   * Crucell announced that an agreement was reached to relocate     Crucell's Korean production facility from the Shingal site in     Yongin City, Korea to the Incheon Free Economic Zone. All parties     involved have agreed on the time line and conditions of this     relocation, enabling a smooth transition to the new production     facility. With engineering well underway, construction activities     at the new site are starting. The new facility will enable the     further growth and efficient production of Quinvaxem(R) and     Hepavax-Gene(R). No further details were provided. [October 2008]   * Crucell announced a non-exclusive PER.C6(R) research license     agreement with the Australian-based company Arana Therapeutics,     Ltd for the production of monoclonal antibodies. Financial     details of the agreement were not disclosed. [October 2008]   * Crucell announced a non-exclusive PER.C6(R) research license     agreement with the Australian-based company Abraxis Bioscience,     Inc., for the production of proteins. Financial details of the     agreement were not disclosed. [October 2008]   * Crucell announced the sale of its fully-owned subsidiary Etna     Biotech Srl (Catania, Italy) to Zydus Cadila (Ahmedabad, India).     The sale results in net proceeds for Crucell of several hundred     thousand Euros. This transaction is in line with Crucell's     increased focus on the strengths of its core business. [November     2008]   * Crucell announced a non-exclusive manufacturing, sales and     distribution agreement with Cambridge-based Biochrom AG related     to the PERMEXCIS(TM) cell culture medium developed by Crucell for     PER.C6(R) cells.     Biochrom is one of the leading European manufacturers of tissue     culture media, animal sera, and buffers for the pharmaceutical     industry. Established in 1981, the company manufactures and     distributes the full range of products related to mammalian cell     culturing technologies. Biochrom will manufacture the medium, and     in addition will market and sell it in the European Union,     Switzerland, Turkey, Russia and Israel. Financial details of the     agreement were not disclosed. [November 2008] 

Financial Review

Total Revenue and Other Operating Income

Total revenue and other operating income was EUR 82.1 million for the third quarter of 2008, an increase of 31% compared to the same quarter of 2007 (38% in constant currencies). The increase was driven by continued strong sales of paediatric and respiratory vaccines as well as higher license fees.

Increase of license revenues was driven by milestone payments triggered by the Phase II clinical study of our Rabies program, the progress on sanofi pasteur’s FluCell program as well as license income from Talecris Biotherapeutics.

Product sales for the third quarter amounted to EUR 65.6 million and represent sales of paediatric vaccines (44%), travel and endemic vaccines (16%), respiratory vaccines (30%) and other products (10%).

License revenues were EUR 10.4 million in the third quarter, an increase of EUR 8.6 million compared to the same quarter of 2007. License revenues consist of initial payments from new contracts as well as milestones and other payments on existing contracts.

Service fees for the quarter were EUR 2.6 million, compared to EUR 3.7 million last year. Service fees represent revenue for product development activities performed under contracts with partners and licensees.

Other operating income was EUR 3.5 million for the quarter, compared to EUR 1.9 million in the third quarter of 2007.

Cost of Goods Sold

Cost of goods sold for the third quarter of 2008 amounted to EUR 39.6 million, EUR 37.5 million of which represents product costs and EUR 2.2 million represents the cost of service and license activities. Gross margins of 50% compared to 36% in the third quarter of 2007. Gross margins in the third quarter of this year are positively influenced by a significant increase in license income, sales of our flu product (Inflexal(R) V) and better production yields, as well as improved plant utilization due to higher volumes. Positive currency effects also contributed approximately 2.5 percentage points to gross margins.

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 third quarter were EUR 33.5 million, representing a EUR 6.0 million increase over the same period in 2007 (EUR 27.6 million).

R&D expenses for the third quarter amounted to EUR 17.7 million, which represents a EUR 5.3 million increase versus the third quarter of 2007. The increase can be attributed to the timing of specific R&D expenses during the year. Overall R&D spending for the full year is expected to be around EUR 70 million.

SG&A expenses for the quarter were EUR 15.9 million, which represents a EUR 0.6 million increase versus the third quarter of 2007. This increase was due to higher one-off expenses in the same quarter last year and includes costs related to the ‘Healthy Ambition’ operational excellence program.

Net financial income and divestments in the third quarter of EUR 2.6 million was the result of foreign exchange gains mainly caused by the increase of the U.S. dollar against the Euro and the sale of Kenta for EUR 1.6 million.

Net Result

Net income of EUR 12.3 million was reported in the third quarter of 2008, compared to a net loss of EUR 4.5 million in the same period of 2007. This amounted to EUR 0.19 net result per share, compared to a net loss per share of EUR 0.07 in the third quarter of 2007.

Balance Sheet

Tangible fixed assets amounted to EUR 150.2 million on September 30, 2008. Intangible assets, representing assets through acquisitions, amounted to EUR 80.5 million. This figure includes acquired in-process research and development, developed technology, patents and trademarks, and value of customer and supplier relationships.

Investments in associates and joint ventures amounted to EUR 8.5 million and mainly represent investments in AdImmune and PERCIVIA. Crucell’s investment in Galapagos NV is classified under available-for-sale investments.

Total equity on September 30, 2008 amounted to EUR 424.5 million. A total of 65.7 million ordinary shares were issued and outstanding on September 30, 2008.

Investment in working capital increased significantly, mainly due to build-up of paediatric vaccine inventory, in anticipation of strong 2009 sales.

Cash Flow and Cash Position

Cash and cash equivalents decreased by EUR 3.0 million in the third quarter to EUR 103.9 million. Deterioration of cash flow and working capital in the first three quarters of 2008 was expected and due to the seasonality of our business.

Net cash used in operating activities in the third quarter of 2008 was EUR 9.9 million, driven by a EUR 26 million net increase in working capital. Overall investments in net working capital increased mainly due to inventory build-up of Quinvaxem(R). In anticipation of the expected further growth of Quinvaxem(R) in 2009, we will continue to build stock of Quinvaxem(R) in the fourth quarter of 2008.

Net cash used in investing activities in the third quarter amounted to EUR 4.4 million. Net cash from financing activities in the third quarter amounted to EUR 11.3 million.

Outlook 2008:

Crucell expects combined full year 2008 total revenue and total other operating income to grow by 25-30% in constant currencies[1]. Prior guidance was 20% growth which has been increased due to a particularly strong third quarter.

Furthermore, Crucell reiterates its expectations that margins will be significantly higher compared to 2007 and that, despite significant investments in inventory build-up in anticipation of strong 2009 paediatric vaccine sales, it expects to end the year cash flow positive.

Forward-looking statements

This press release contains forward-looking statements that involve inherent risks and uncertainties. We have identified certain important factors that may cause actual results to differ materially from those contained in such forward-looking statements. For information relating to these factors please refer to our Form 20-F, as filed with the U.S. Securities and Exchange Commission on May 7, 2008, and the section entitled “Risk Factors”. The Company prepares its financial statements under International Financial Reporting Standards (IFRS).

Conference Call and Webcast

At 14:00 Central European Time (CET), Crucell’s management will conduct a conference call, which will also be webcast. To participate in the conference call, please call one of the following telephone numbers 10 minutes prior to the event:

                     +44 203 023 4471 for the UK;                    +1 646 843 4608 for the US; and                  +3120 794 8426 for the Netherlands 

Following a presentation of the results, the lines will be opened for a question and answer session.

The live audio webcast can be accessed via the homepage of Crucell’s website at www.crucell.com and will be archived and available for replay following the event.

About Crucell

Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a global biopharma company focused on research, development, production and marketing of vaccines, proteins and antibodies that prevent and treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell’s core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera vaccine and the only aluminum-free hepatitis A vaccine on the market. The Company has a broad development pipeline, with several product candidates based on its unique PER.C6(R) production technology. The Company licenses its PER.C6(R) technology and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM Biologics, sanofi-aventis, Novartis, Wyeth and Merck & Co. Crucell is headquartered in Leiden, the Netherlands, with subsidiaries in Switzerland, Spain, Italy, Sweden, Korea and the U.S. The Company employs over a 1000 people. For more information, please visit www.crucell.com.

 Financial Calendar: 17 February 2009       Q4 Results 2008 6 May 2009               Q1 Results 2009 5 June 2009               Annual General Meeting of Shareholders 11 August 2009         Q2 Results 2009 3 November 2009       Q3 Results 2009 9 February 2010        Q4 Results 2009 For further information please contact: Crucell N.V. Oya Yavuz Director Corporate Communications & Investor Relations Tel. +31-(0)71-519 7064 [email protected] www.crucell.com 

[1] Constant currencies = Weighted average EUR/USD rate of 1.38 in 2007.

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SOURCE: Crucell N.V.