SOURCE: Crucell N.V.

November 03, 2009 01:57 ET

Crucell Announces Third Quarter 2009 Results

LEIDEN, NETHERLANDS--(Marketwire - November 3, 2009) -


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

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


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

Highlights:

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


Financial Highlights:

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


Key Figures:
(EUR  million, except net result per share)

      Third Quarter                       Nine months ended September
                                                      30
2009      2008      Change                2009       2008      Change
unaudited unaudited                        Unaudited unaudited

                           Total revenues
                             and other
                             operating
     94.3      82.1    15%     income          246.7     189.6    30%

                             Operating
     15.5       9.6    62% profit/(loss)        21.0     (2.5)      -


                                Net
     10.0      12.8  (22)% profit/(loss)         8.4     (3.1)     -

                           Net result per
                               share
     0.15      0.19  (21)%    (basic)           0.13    (0.05)    -


Crucell's Chief Executive Officer Ronald Brus said:

"The recently announced collaboration with Johnson & Johnson - the world's largest healthcare company - has a potential deal value of over EUR 1 billion and reflects the innovative strength of our company. It represents an important validation of the promise of our new class of broadly protective anti-influenza antibodies. The immediate focus of this exciting collaboration will be the development and commercialization of a universal monoclonal antibody product (flu-mAb) for the prevention and treatment of any type of influenza strain. In addition, we will receive a significant amount of potential milestones throughout the development period as well as royalty payments upon commercialization of the products, whilst retaining commercialization rights for the European Union, certain additional European countries and supranational organizations.

"Over the past few years we have made great strides in building on our innovation and excellence in the global fight against infectious diseases. We have been able to accelerate our product sales significantly and expand our promising R&D programs. Our researchers focus on the discovery and development of much-needed solutions for major threats to human health, resulting in a strong pipeline of candidate products with the potential to revolutionize the fight against diseases such as influenza, rabies, malaria and tuberculosis.

"Crucell is becoming stronger and more effective as a global force in healthcare. Our goal has been, and remains, to strengthen our ability to bring meaningful innovation to global health by actively investing in our pipeline and by building on our existing knowledge of the vaccine and antibody markets in infectious disease."


Product Sales Update:

Product sales in the third quarter of 2009 increased 28% over the same quarter in 2008 to EUR 83.7 million and represent sales of paediatric vaccines (46%), travel and endemic vaccines (14%), respiratory vaccines (31%) and other products (9%).

Crucell started its own dedicated marketing and sales organization in the United Kingdom by acquiring an experienced team, which will further strengthen its vaccine sales position in one of the largest vaccine markets in Europe. The UK team will market and sell Epaxal®, Vivotif®, Dukoral® and Inflexal® V. Distribution of the travel vaccines has started, distribution of the influenza vaccine will start in 2010.

Paediatric

Sales of our paediatric vaccines, continued to show good growth in the third quarter 2009, particularly 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 against hepatitis A for use in children.
  * MoRu-Viraten®: Vaccine for protection against measles and rubella
    (for all age groups).

Travel and Endemic

In the third quarter of 2009, sales of our travel and endemic portfolio showed solid growth. Our travel portfolio has seen limited impact from the economic crisis as we were able to compensate sales declines with good uptake of our hepatitis A vaccine Epaxal® in new territories.


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

Respiratory

The third quarter of 2009 showed solid growth, compared to the same quarter of 2008 of our flu vaccine Inflexal® V. Sales of Inflexal® V were particularly strong, due to the global strong demand for flu products. Shipments of Inflexal® V were mainly phased into the third quarter and thus earlier than sales in 2008.


  * 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.

Research & Development:


  * Flavimun® - Live Attenuated Yellow Fever Vaccine (Phase III):
    Flavimun® was submitted for registration in Switzerland in March
    2009. Submission in Germany is expected within the next few
    months.



  * Influenza - Seasonal Flu Vaccine (Phase II; FluCell collaboration
    with Sanofi Pasteur): This seasonal influenza vaccine is being
    developed by Sanofi Pasteur, using Crucell's 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.



  * Human Monoclonal Antibodies against a broad range of Influenza
    strains (Preclinical):  Crucell's scientists discovered a set of
    human monoclonal antibodies that provide immediate protection and
    neutralize 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 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.
  * In August 2009 Crucell received an award from the National
    Institute of Allergy and Infectious Diseases (NIAID)/National
    Institutes of Health (NIH) for the development of its monoclonal
    antibodies for the treatment of seasonal and pandemic influenza.
    The award provides funding of up to $40.7 million, with
    additional options that may be triggered at the discretion of the
    NIH worth a further $28.4 million, bringing the potential total
    amount to $69.1 million.
  * In September JNJ, through its subsidiary Ortho-McNeil-Janssen
    Pharmaceuticals, Inc., and Crucell entered into a strategic
    collaboration focusing on the discovery, development and
    commercialization of monoclonal antibodies and vaccines for the
    treatment and prevention of influenza and other infectious and
    non-infectious diseases.
  * The immediate focus of the collaboration will be the development
    and commercialization of a universal monoclonal antibody product
    (flu-mAb) for the treatment and prevention of influenza. The
    focus of the long-term innovation collaboration will be on new
    discovery programs leading to the development and
    commercialization of a universal influenza vaccine as well as the
    development of monoclonal antibodies and/or vaccines directed
    against up to three other infectious and non-infectious disease
    targets.



  * Rabies Human Monoclonal Antibody Combination/CL184 (Phase II):
    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 the 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 EUR 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
    have been presented at the XX Rabies in the Americas RITA
    conference in Quebec, Canada on 20 October 2009.
  * Plans to start an additional Phase II clinical study are
    progressing well after recent approval received from the Drug
    Controller General of India. This third Phase II study will be
    carried out at Lotus Laboratories in Bangalore, India and is
    planned to start within the next six months. The rationale for
    this study is to collect safety and neutralizing activity data of
    the CL184 antibody in combination with the vaccine in a simulated
    rabies post-exposure prophylaxis setting to be used in Phase III.



  * Tuberculosis Vaccine (AdVac®/PER.C6® Technology based; Phase
    II):  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 candidate vaccine at all dose levels evaluated.
  * 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 vaccine is being tested in 116
    adults who have had active TB. This study is currently enrolling.
    No evidence of an unacceptable safety issue has been found in its
    dose escalation design after enrollment and vaccination of 60
    subjects to date.
  * Phase I: The 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 in combination with the
    AERAS-402/Crucell Ad35 candidate vaccine 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 has been completed, with ongoing
    analysis and no safety issues identified.
  * In April 2009, a Phase I clinical trial in infants of the jointly
    developed TB candidate vaccine AERAS-402/Crucell Ad35 was started
    in South Africa. This is the first clinical trial designed to
    test this candidate vaccine in infants. The Phase I study of
    AERAS-402/Crucell Ad35 is being conducted by the South African
    Tuberculosis Vaccine Initiative (SATVI) in the Western Cape
    region of South Africa. The main objective of the study is to
    test the safety of the TB candidate vaccine in infants previously
    vaccinated with BCG vaccine, which is currently the only vaccine,
    licensed to help prevent TB. This study is fully enrolled and
    dosing is ongoing. No safety issues have been identified.



  * Malaria Vaccine (AdVac®/PER.C6® Technology based; Phase I):
    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 candidate vaccine 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 four 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 (AdVac®/PER.C6®
    Technology based; Phase I): In October 2008 Crucell announced
    that it has secured a NIAID/NIH award to advance the development
    of Ebola and Marburg vaccines, with the ultimate aim of
    developing a multivalent filovirus vaccine. The award 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 (AdVac®/PER.C6® Technology based; Phase I): 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 has been fully enrolled. Boost vaccinations are
    ongoing. On 21 October 2009 preliminary results of the Phase I
    study were presented at La Conférence AIDS Vaccine 2009 in Paris,
    France. The presentation was given by Dr Dan H. Barouch, MD, PhD,
    Associate Professor of Medicine, Division of Vaccine Research,
    Department of Medicine at the Beth Israel Deaconess Medical
    Center (BIDMC) in Boston, USA. The preliminary results of this
    study show that this HIV candidate vaccine is safe and
    immunogenic.



  * 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.



  * Hepatitis C Antibody Combination (Preclinical): In August 2009
    Crucell 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  (Research):  Preclinical work on
    this program continues but conclusive proof of concept is not
    expected in the near future.


Building Development Capability:

To strengthen Crucell's capabilities to deliver on its pipeline, the company hired 110 new employees since January 2009. With these new employees Crucell strengthens its team with new leadership and process experts. Many of these new colleagues will be working in Switzerland, in the two buildings that have been reutilized to establish new process development laboratories. Crucell will use these laboratories to get FDA approval for Epaxal® in the USA.


Korean Production Facility:

In October 2008 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, Korea. Construction activities at the new site started in December 2008 and are progressing well. First test runs are planned for the first half of 2010. The new facility will enable the further growth and efficient production of Quinvaxem® and Hepavax-Gene®. The investments in the new facility are expected to total approximately EUR 50 million, with the majority of spending in 2009.


The Crucell Ambition:

In 2008, The Crucell Ambition program was rolled out throughout the Company, focusing on four priority areas. These areas are: Organization & People, Focus, Operational Excellence, and Deliver on Promises.

The Operational Excellence 'Healthy Ambition' part of the program is targeting savings of EUR 30 million by the end of 2009 compared to the 2007 cost base (excluding R&D). In the first nine months of 2009, a total of EUR 15 million of net cost savings were achieved (Q1 2009 EUR 6 million; Q2 2009 EUR 4 million; Q3 2009 EUR 5 million). Savings were predominantly achieved through improved yields, marketing and sales efficiency gain, and savings in overhead.


Manufacturing & Licensing Agreements:


  * Crucell announced a non-exclusive PER.C6® research license
    agreement with Australia-based Patrys Ltd. for the production of
    several undisclosed antibodies. Financial details of the
    agreement were not disclosed. [July 2009]
  * Crucell today announces a non-exclusive PER.C6® research license
    agreement with US-based TapImmune Inc. for use in its vaccine
    development programs. Financial details of the agreement were not
    disclosed. [September 2009]
  * Crucell today announces an agreement with US-based Calmune
    Corporation, including an exclusive license on an undisclosed
    antibody based on Calmune's technology and a co-development for
    the discovery of new antibodies against the same target.
    Financial details of the agreement were not disclosed. [September
    2009].


Patents:

In Q3 2009 Crucell was granted a total of 22 patents, including patents for:


  * Monoclonal antibodies against rabies, in the U.S. and Singapore
  * AdVac® based malaria vaccines, in Australia
  * Production of antibody fragments using PER.C6® expression
    technology, in Australia
  * Elements of STAR® technology, in India
  * Improvements in PER.C6® expression technology, in New Zealand
  * Purification of AdVac® vectors, in Europe and New Zealand


Financial Review Third Quarter 2009

Total Revenues and Other Operating Income

Total revenues and other operating income amounted to EUR 94.3 million for the third quarter of 2009, an increase of 15% compared to the same quarter of 2008. The increase of 15% was mainly driven by strong sales of paediatric and respiratory vaccines. Travel and endemic vaccines also showed solid growth due to the growth of Epaxal®, despite the impact of reduced travel from the economic crisis.

Product sales in the third quarter of 2009 increased 28% over the same quarter in 2008 to EUR 83.7 million and represent sales of paediatric vaccines (46%), travel and endemic vaccines (14%), respiratory vaccines (31%) and other products (9%).

License revenues were EUR 3.8 million in the third quarter, a decrease of EUR 6.6 million compared to the third quarter of 2008 (which included milestone payments of EUR 6.0 million for the Phase II results of the rabies monoclonal antibody combination and for Sanofi Pasteur's seasonal influenza vaccine (FluCell).

Service fees for the quarter were EUR 2.4 million, compared to EUR 2.6 million last year. Service fees represent revenues for product development activities performed under contracts with partners and licensees.

Other operating income was EUR 4.4 million for the quarter, compared to EUR 3.5 million in the third quarter of 2008.

Cost of Goods Sold

Cost of goods sold for the third quarter of 2009 amounted to EUR 55.1 million, EUR 53.1 million of which represents product costs and EUR 2.0 million the cost of service and license activities.

In line with expectations, gross margins were 39% in the quarter, compared to 50% in the same period in the prior year. The timing of development milestone payments from partners significantly influence margins and profitability in the period in which they are recognized. The third quarter of 2008 included EUR 6.0 million milestone payments. The remaining drop in margins is due to unfavorable movement of the US Dollar versus the Euro. We expect continued pressure on margins in the last quarter of the year as a result of exchange rates, which affects our reported product sales and cost of goods sold.

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 23.7 million, representing a EUR 9.2 million decrease compared to the same period in 2008. The decrease was mainly due to the reversal of impairment of two buildings in Switzerland, which were selected as development production sites for Epaxal® (hepatitis A) and tuberculosis vaccines.

SG&A (M&S+G&A) expenses for the quarter were EUR 15.2 million compared to EUR 15.2 million in the third quarter of 2008.

Operating profit was EUR 15.5 million in the third quarter of 2009 compared to EUR 9.6 million operating profit in the same quarter of 2008. Operating profit was positively affected by a EUR 8.1 million impairment reversal of two state-of-the-art buildings in Bern (Switzerland). The buildings were impaired in the fourth quarter of 2006 as there was no direct use for the buildings. In 2009 alternative use of the buildings arose as additional development facilities were required for two strategic development programs and the buildings proved to be suitable. The buildings are currently being adapted to the specific needs of the development programs, which will avoid major spending in the construction of new development facilities. The initial impairment that was already partially reversed in the first quarter of 2008 for an amount of EUR 5.2 million has now fully been reversed.

Financial Expenses and Taxes

Net financial expenses in the third quarter were EUR 0.9 million. This was mainly the result of interest expenses and currency losses on the US Dollar.

The company recorded a EUR 4.6 million income tax charge in the third quarter of 2009, mainly due in Switzerland, Spain and Korea. The consolidated effective income tax rate was 32% in the third quarter of 2009. The consolidated profit before tax was reduced by a significant operating loss in the Netherlands as a result of R&D expenses for which no tax benefit is recognized. This led to a relatively high effective tax rate. A further tax charge was due to the reversal of impairment.

Net Result

Net income of EUR 10.0 million was reported in the third quarter of 2009 versus a net income of EUR 12.8 million in the same quarter of 2008. Net result per share in the third quarter of 2009 is EUR 0.15, compared to a net result per share of EUR 0.19 in the third quarter of 2008.

Balance Sheet

Tangible fixed assets amounted to EUR 178.3 million on September 30, 2009. Intangible assets amounted to EUR 73.8 million. This includes acquired in-process research and development, developed technology, patents and trademarks, and the value of customer and supplier relationships.

Investments in associates and joint ventures amounted to EUR 9.3 million and mainly represent investments in AdImmune and the PERCIVIA PER.C6® Development Center. Crucell's investment in Galapagos NV is classified under available-for-sale investments.

As part of the strategic collaboration with JNJ, the company sold 14.6 million newly issued ordinary shares to JNJ for an aggregate purchase price of EUR 301.8 million, which included a premium of EUR 69.5 million classified as deferred income, which will be amortized over the development period of flu-mAbs.

Total equity on September 30, 2009 amounted to EUR 717.5 million. A total of 81.3 million ordinary shares were issued and outstanding on September 30, 2009.

Cash Flow and Cash Position

Cash and cash equivalents increased by EUR 190.0 million in the third quarter to EUR 311.6 million.

Net cash from operating activities in the third quarter improved significantly to EUR 72.1 million, up from minus EUR 9.9 million in the same quarter of 2008. This was driven by the upfront payments of JNJ for participation in Crucell's development programs.

Cash used in investing activities amounted to EUR 118.0 million, which includes a long term deposit of EUR 100.0 million with a maturity of over 3 months, to take advantage of higher yields on longer term deposits.

Net cash from financing activities in the third quarter was EUR 235.0 million, compared to EUR 11.3 million in the same quarter of 2008. This increase reflects the cash proceeds from the issuance of shares to JNJ.


Outlook 2009 reiterated [2]

  * 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.
  * Maintain current strong cash position.
  * Crucell does not expect its results to be materially affected by
    the global recession.

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 US Securities and Exchange Commission on April 22, 2009, in 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 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 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: CRX) is a global biopharmaceutical company focused on research development, production and marketing of vaccines, proteins and antibodies that prevent and/or 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, GSK, CSL and Merck & Co. Crucell is headquartered in Leiden, the Netherlands, with subsidiaries in Argentina, China, Italy, Korea, Spain, Sweden, Switzerland, UK and the USA. The Company employs over 1200 people. For more information, please visit www.crucell.com.

Financial Calendar
9 February 2010       Q4 Results 2009
11 May 2010            Q1 Results 2010
4 June 2010             Annual General Meeting of Shareholders
17 August 2010        Q2 Results 2010
9 November 2010      Q3 Results 2010
15 February 2011      Q4 Results 2010

For further information please contact:
Crucell N.V.
Oya Yavuz
Vice President
Corporate Communications & Investor Relations
Tel. +31 (0)71 519 7064
ir@crucell.com
www.crucell.com
____________________

[1] The discovery and characterization of this unique class of human influenza antibodies was reported in the online journal PloS ONE on 16 December 2008. An imaging study published in the prestigious journal Science on 26 February 2009 described the mechanism explaining their broad-spectrum protection by showing that the antibody binds to a part of the influenza virus that is conserved (invariable) from one viral strain to the next. Antibodies produced by the body in response to influenza infection or vaccination bind to a part of the virus that tends to mutate.

[2] Constant currencies = EUR/USD rate of 1.35

PDF file including financials: http://hugin.info/132631/R/1352094/326992.pdf


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