SOURCE: Crucell N.V.

November 11, 2008 01:59 ET

Crucell Announces Third Quarter 2008 Results

LEIDEN, NETHERLANDS--(Marketwire - November 11, 2008) - 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® and Hepavax-Gene® 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® 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® cell line.
  * DSM and Crucell announced another key achievement for PER.C6®
    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™
    cell culture medium developed by Crucell for PER.C6® 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® 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® in
    2009, we will continue to build stock of Quinvaxem® 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®.


  * 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 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®: 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®: The only aluminium-free vaccine against hepatitis A.
  * Vivotif®: The only oral vaccine against typhoid fever.
  * Dukoral®: 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® V.


  * 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 the flu
    products in the second half of the year.

Pipeline Update:


  * Flavimun® - 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® 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® 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®/PER.C6® 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-Guérin (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®/PER.C6® 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®/PER.C6® 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®/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, 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® vaccine- 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 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® technology platform:


  * DSM Biologics and Crucell announced that the high-titer fed-batch
    process developed at the PERCIVIA PER.C6® 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® cells using chemically
    defined cell culture medium in a SUB (single-use bioreactor).
    This result  is  further  confirmation that  PER.C6®  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®  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™ technology.

Manufacturing & Licensing Agreements:


  * Lonza and Crucell entered into a co-exclusive manufacturing,
    sales and distribution agreement related to the PERMEXCIS™
    cell culture medium developed by Crucell for PER.C6® 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™  medium is  a chemically  defined cell  culture
    medium that does not contain human- or animal-derived components.
    PERMEXCIS™ medium was developed for the cultivation of PER.C6®
    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® based manufacturing  processes than some  of the  current
    available media for PER.C6® 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® 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® 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® elements, in Israel
  * Stable adenoviral AdVac® vectors, in Europe
  * Improved methods for the production of viruses using PER.C6®
    cells, in India
  * Adenoviral vector based malaria vaccines, in New Zealand
  * Technology for the production of antibody mixtures using PER.C6®
    cells, in the U.S. and New Zealand
  * Improvements in PER.C6® 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® and
    Hepavax-Gene®. No further details were provided. [October 2008]



  * Crucell announced a non-exclusive PER.C6® 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® 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™ cell culture medium developed by Crucell for
    PER.C6® 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® 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®. In anticipation of the expected further growth of Quinvaxem® in 2009, we will continue to build stock of Quinvaxem® 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® production technology. The Company licenses its PER.C6® 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
ir@crucell.com
www.crucell.com

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

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