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Tuesday 09 November, 2010

Crucell N.V.

Crucell Reports Third Quarter 2010 Results






                   Crucell Reports Third Quarter 2010 Results
      One-time inventory provision for Quinvaxem® stock of €22.8 million.

     Total revenues and other operating income of €89.5 million compared to
                   €94.3 million in the same period in 2009.
        Operating loss of €31.1 million compared to operating profit of
 €15.5 million in Q3 2009. Net loss of €27.0 million compared to net profit of
      €10.0 million in Q3 2009 due to write-downs of Quinvaxem® inventory.
  Undiluted EPS of minus €0.33 compared to €0.15 in the same quarter of 2009.

Change of 2010 guidance: total revenues and other operating income[1] for the
full year expected to be in-line with 2009 levels. Due to the one-time
provision, operating loss for the year expected to be €20-25 million.

Leiden,  the  Netherlands  (November  9, 2010) - Dutch biopharmaceutical company
Crucell  N.V. (NYSE Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announced
its  financial results  for the  third quarter  of 2010, based  on International
Financial Reporting Standards (IFRS). These financial results are unaudited.

Business Highlights:

  * On October 28, 2010 Crucell announced that it has put a temporary hold on
    all shipments of Quinvaxem® and Hepavax-Gene®. Crucell also suspended
    production at the Shingal facility in Korea as the sterile operation had
    been compromised during recent operations. Current analysis indicates that a
    microbiological contamination has occurred and investigation into the root
    cause is ongoing. The Shingal facility was already scheduled to be vacated
    next year. The operations in our new Incheon facility are not affected.
    There are no concerns in terms of product safety in relation to the use of
    any of the vaccines that have already been distributed. All products
    currently in the market were manufactured in compliance with GMP regulations
    and have passed all release tests, including, without exception, all
    sterility analyses.
    The investigation into the root cause of the contamination is progressing
    well and actions are being taken to resume manufacturing at the Shingal
    facility in the coming weeks. The company has taken a €22.8 million
    inventory provision on all Quinvaxem® stock. Crucell's responsibility to the
    children in developing countries is paramount and we have committed all
    required resources to resolve this issue expeditiously. We are working with
    all stakeholders to understand the circumstances surrounding these events
    and to assess the situation.


  * On October 6, 2010 Johnson & Johnson and Crucell announced an agreement
    whereby Johnson & Johnson, through an affiliate, would acquire all
    outstanding equity of Crucell that it does not already own for approximately
    €1.75 billion in a recommended cash tender offer; this reflects an intended
    all cash offer of €24.75 per share for all outstanding shares not already
    owned by Johnson & Johnson. As reported by Johnson & Johnson in the press
    release, Crucell would become the center for vaccines within the Johnson &
    Johnson pharmaceutical group whilst retaining its innovative and
    entrepreneurial culture and dedicated employees. Crucell expects that it
    would further accelerate and expand its product and pipeline development, as
    well as its ability to provide vaccines to people around the world, as a
    Johnson & Johnson company.


  * On October 29, 2010 Johnson & Johnson and Crucell reported that the
    companies are making progress on the preparations for the intended public
    offer. Johnson & Johnson reported that it currently expects to request and
    obtain the final approval of the offer document from the AFM and to be in a
    position to launch the Offer before the end of November, as previously
    announced.


  * Crucell today announces the start of a discovery program leading to the
    development and commercialization of an Human Papilloma Virus (HPV) vaccine.
    This discovery program is part of the existing strategic collaboration with
    Johnson & Johnson, through its subsidiary Ortho-McNeil-Janssen
    Pharmaceuticals, Inc., signed in September 2009, to develop innovative
    products, including antibodies for influenza prevention and treatment.


  * DSM and Crucell announced an expansion of the activities in their existing
    joint venture, the PERCIVIA PER.C6® Development Center (Cambridge,
    Massachusetts, United States), to transform the company from a development
    center into a full biopharmaceutical company for the development of PER.C6®-
    based biobetter proteins and monoclonal antibodies as well as global
    licensing of the PER.C6® human cell line for production of third party
    monoclonal antibodies and other proteins.


  * Crucell and the Aeras Global TB Vaccine Foundation announced the start of a
    Phase II clinical trial in infants of the jointly developed tuberculosis
    vaccine candidate, AERAS-402/Crucell Ad35.


  * Crucell announced that the International AIDS Vaccine Initiative (IAVI) has
    started with a Phase I clinical trial to evaluate the safety and
    immunogenicity of two preventive AIDS vaccine candidates.



Financial Highlights:
  * The Company announced combined total revenues and other operating income of
    €89.5 million, compared to €94.3 million in the third quarter of 2009. The
    decrease was driven by a decline in respiratory vaccine sales.


  * Product sales were €72.8 million, representing sales of paediatric vaccines
    (67%), travel and endemic vaccines (14%), respiratory vaccines (14%), and
    other products (5%). Higher sales of paediatric vaccines were more than off-
    set by lower sales of respiratory vaccines due to a later start of the flu
    season.


  * Gross margins were 7%, compared to 39% in the third quarter of 2009. Gross
    margins were significantly impacted by the provision for Quinvaxem®
    inventory, pricing of Quinvaxem® sales, variation in product mix and
    negative operating variances.


  * Research and development (R&D) expenses increased to €26.8 million, compared
    to €16.5 million in the third quarter of 2009 as R&D program spending
    accelerated in line with guidance.


  * Operating loss of €31.1 million for the third quarter, compared to €15.5
    million operating profit in the same period of 2009.


  * Net loss of €27.0 million for the third quarter of 2010, compared to a net
    profit of €10.0 million in the third quarter of 2009. Net loss per share of
    €0.33, compared to a net profit per share of €0.15 in the same period of
    2009.


  * Cash from operating activities decreased to €17.3 million compared to €72.1
    million in the same period of 2009. In the third quarter of 2009 the cash
    received from the Johnson & Johnson collaboration, relating to the
    development programs, was included in the cash from operating activities.


  * Cash from investing activities amounted to €29.1 million in the third
    quarter, which is mainly due to reclassification of financial deposits.


  * Net cash from financing activities in the quarter amounted to €0.2 million
    compared to €235.0 million in the same period of 2009, as the third quarter
    of 2009 included the 18% equity stake of Johnson & Johnson.


  * Cash and cash equivalents increased by €46.6 million during the third
    quarter to €292.1 million.



Key Figures: (€ million, except net result per share)
--------------------------------------------------------------------------------
      Third Quarter                                       Nine months ended
                                                             September 30
--------------------------------------------------------------------------------
     2010      2009 Change                                 2010      2009 Change
unaudited unaudited                                   unaudited unaudited
--------------------------------------------------------------------------------

                            Total revenues and other
     89.5      94.3   (5)%      operating income          283.8     246.7    15%

   (31.1)      15.5         Operating profit/(loss)      (22.3)      21.0


   (27.1)      10.0            Net profit/(loss)         (20.1)       8.4


                              Net result per share
   (0.33)      0.15                 (basic)              (0.25)      0.13


Crucell's Chief Executive Officer Ronald Brus said:

"Resolving  the contamination  issue in  our Shingal  facility is our number one
priority.  We are totally committed to  provide children in developing countries
with  the highest quality vaccines. We  have mobilized all required resources to
investigate  and correct the  problem so we  can resume shipments  in the coming
weeks.

We are working together with all stakeholders to understand and correct the root
cause of the contamination. We have no concerns about the safety of our products
in  the market, which have passed all  release tests. We remain confident in the
safety  and quality of our most  important paediatric vaccine Quinvaxem® and its
role  to  protect  children  in  the  developing  world  against  five important
infectious diseases.

In  October we reached an  agreement with Johnson &  Johnson for an intended all
cash  offer of €24.75 per  share. We will hold  an informational EGM on December
10, 2010 to  discuss the offer in more detail with our shareholders. The Crucell
Boards fully support this offer as this potential transaction creates a powerful
platform for vaccine development. This potential transaction would allow Johnson
&  Johnson to invest in  the development of Crucell's  products and pipeline and
support  Crucell's mission  to increase  the number  of people  around the globe
protected from infectious diseases."

Product Sales Update:
Product  sales in the third quarter  of 2010 decreased 13% over the same quarter
in  2009 to  €72.8  million  and  represent  sales of paediatric vaccines (67%),
travel  and  endemic  vaccines  (14%),  respiratory  vaccines  (14%),  and other
products  (5%). Higher  sales of  paediatric vaccines  were more than off-set by
lower sales of respiratory vaccine sales due to a later start of the flu season.

Paediatric vaccines
Crucell  has  established  that  recently  the  sterile operation of our Shingal
facility  (Korea) had been compromised. As a precautionary measure we have put a
temporary  hold  on  all  shipments  of  Quinvaxem®  and Hepavax-Gene® that were
planned for delivery. The investigation into the root cause of the contamination
is  progressing well and actions are being  taken to resume manufacturing at the
Shingal  facility in  the coming  weeks. The  company has  taken a €22.8 million
inventory provision on all Quinvaxem® stock, related to the contamination.

All  products currently in the market  have passed all release tests, including,
without  exception, all sterility analyses. There are no concerns in relation to
the use of any of the material that was distributed in terms of product safety.

In the third quarter, Quinvaxem® sales were strong due to additional demand from
UNICEF and PAHO.

Travel and endemic vaccines
After  a strong first  half of this  year, travel sales  in the third quarter of
2010 were  flat compared to  the same quarter  of last year.  We continue to see
progress   in   upscaling  the  production  process,  required  to  prepare  for
introduction of Epaxal® in the US.

Respiratory vaccines
Sales  of Crucell's influenza vaccine Inflexal® V  in the quarter were lower due
to  strong comparables  in the  same quarter  last year  driven by  a strong flu
season  last  season.  Due  to  limited  availability  of flu antigen and weaker
overall  demand, fourth  quarter 2010 sales  of Inflexal®  V are  expected to be
lower than the fourth quarter in 2009.

Research & Development Highlights:
  * Human Monoclonal Antibodies against a broad range of Influenza strains (pre-
    clinical): In September 2009 Johnson & Johnson (JNJ), through its subsidiary
    Ortho-McNeil-Janssen Pharmaceuticals, Inc., and Crucell entered into a
    strategic collaboration for the development and commercialization of a
    universal monoclonal antibody product (flu-mAb) for the treatment and
    prevention of influenza. An important activity in the development of this
    flu-mAb has been the first production of this antibody product in a mobile
    and fully disposable FlexFactory®. In addition the strategic collaboration
    involves four innovative discovery programs focusing on the development and
    commercialization of a universal influenza vaccine as well as vaccines
    directed against three other infectious and non-infectious disease targets -
    including RSV and HPV (see below). Activities for the universal influenza
    vaccine, which started in January, are ongoing. The universal influenza
    vaccine will be designed based on specific epitopes of our broadly cross-
    neutralizing influenza antibodies. The selection of the other innovation
    targets is ongoing.


  * Therapeutic Human Papilloma Virus (HPV) Vaccine (pre-clinical): Today
    Crucell announces the start of a discovery program leading to the
    development and commercialization of an HPV vaccine. Genital infection with
    HPV is very common in both men and women and usually spontaneously cleared
    within one year after infection. In about 1% of individuals, however, HPV
    persists, ultimately resulting in genital neoplastic lesions. This discovery
    program is part of the strategic collaboration with JNJ (see above).


  * Influenza - Seasonal Influenza Vaccine: Crucell has commenced with the
    development of a cell-based influenza vaccine. The introduction of cell-
    based Inflexal® V will be the next important step for Crucell's respiratory
    franchise. Combining Crucell's high density PER.C6® production system with
    the company's proprietary virosomal technology creates a cutting-edge method
    to produce Inflexal® antigens both at large scale, at very competitive cost
    levels and earlier in the season. Crucell expects to apply for licensure in
    2014.


  * AIDS/HIV Vaccine (Phase I): In April 2008, Crucell announced the start of a
    Phase I clinical study of the novel recombinant HIV vaccine. The preliminary
    results of this Phase I study were updated at the AIDS Vaccine 2010
    conference in Atlanta, GA in Sept 2010 confirming the safety and
    immunogenicity of this HIV candidate vaccine vector.

    In August 2010 Crucell announced its participation in an international Phase
    I clinical trial in the United States and Africa of a combination of two
    AdVac®-based AIDS vaccine candidates, Ad26.ENVA.01 and Ad35-ENV, in healthy
    adults who are not infected with HIV. The clinical trial has started in
    October 2010 and will be led by the International AIDS Vaccine Initiative
    (IAVI), representing a collaboration between IAVI, Crucell, the Ragon
    Institute, and Beth Israel Deaconess Medical Center (BIDMC), a major
    teaching hospital of Harvard Medical School.

    The Ad26.ENVA.01 vaccine candidate used in this study is manufactured by
    Crucell, while the Ad35-ENV vaccine is developed by IAVI. Both vaccines
    candidates are based on Crucell's proprietary AdVac® technology. The planned
    Phase 1 trial of the vaccine combination, which follows a Phase I trial of
    the Ad35-ENV vaccine by IAVI and a Phase I trial of Ad26.ENVA.01 by the
    Harvard-Crucell consortium, supported by the National Institute of Allergy
    and Infectious Diseases (NIAID), represents a key step towards proof of
    concept studies to evaluate the efficacy of the vaccine combination in
    humans.


  * Tuberculosis Vaccine (Phase II): To date, 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.

    A Phase II clinical trial in infants of AERAS-402/Crucell Ad35 started in
    October 2010. The main objective of the trial is to test the safety and
    efficacy of the TB vaccine candidate in infants previously vaccinated with
    the Bacille Calmette-Guérin (BCG) vaccine, which is currently the only
    vaccine licensed to help prevent TB. The first part of this clinical trial,
    which is conducted in Kenya, will establish the optimal dosing regimen. The
    selected regimen will then be tested in the second part of the trial,
    planned to begin in 2011 in Kenya, Mozambique, South Africa and Uganda.


  * Rabies Human Monoclonal Antibody Combination/CL184 (Phase II): Crucell's
    monoclonal antibody combination against rabies is being developed in
    collaboration with sanofi pasteur using Crucell's PER.C6® manufacturing
    technology. The Indian authorities released the material for the additional
    Phase II study in India. This start of this trial is now imminent. This
    study is designed to collect safety and neutralizing activity data of the
    CL184 antibody in combination with the vaccine in a simulated rabies post-
    exposure prophylaxis setting.


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 technical completion  was reached within 13
months.  First test  runs started  in May  2010 and are progressing according to
plan.  The  results  of  the  comparability  studies  done  to  date  are  fully
satisfactory and most of the comparability work will be completed before the end
of this year. The operations in the new Incheon facility are not affected by the
contamination  in  the  old  factory.  The  new facility will enable the further
growth  and highly efficient production of  Quinvaxem® and Hepavax-Gene®, with a
capacity of over 100 million doses annually.


Manufacturing & Licensing Agreements:

  * Crucell today announces that UK-based Eden Biodesign Limited, signed a non-
    exclusive Vendor Network Agreement, whereby Eden has become a pre-approved
    authorized provider of services for contract manufacturing on Crucell's
    proprietary PER.C6® cell-line technology. Under the terms of the agreement
    Eden will be able to offer Contract Manufacturing Services to Crucell's
    PER.C6® licensees in the field of vaccines and gene therapy. Financial
    details of the agreement were not disclosed. [Oct 2010]


PERCIVIA:

DSM  and Crucell have  expanded the activities  in their existing joint venture,
the  PERCIVIA  PER.C6®  Development  Center  (Cambridge,  Massachusetts,  United
States),  to  transform  the  company  from  a  development  center  into a full
biopharmaceutical   company  for  the  development  of  PER.C6®-based  biobetter
proteins  and monoclonal antibodies  as well as  global licensing of the PER.C6®
human  cell line for  production of third  party monoclonal antibodies and other
proteins.
The  joint venture,  in which  DSM and  Crucell will  each hold  an equal equity
share,  will be known as PERCIVIA LLC.  The joint venture will broaden its scope
and  will focus on  proprietary development of  PER.C6®-based biobetter proteins
and monoclonal antibodies, initially to early clinical stages.

Patents:

In Q3 2010 Crucell was granted a total of 34 patents, including patents for:

  * Aspects of PER.C6® recombinant protein glycoform expression technology, in
    the U.S.
  * Different aspects of improved adenoviral AdVac® vectors, in India, in Canada
    and in Singapore
  * Cell lines for improved adenovirus production, in Australia
  * Elements of STAR® technology, in Europe, in Singapore and in the U.S.
  * Chimeric adenoviruses that can target different specific cell types, in the
    U.S.
  * Improvements in influenza virus isolation using PER.C6® technology, in Korea
  * Genetically engineered Vibrio choleraestrains, in Europe



Financial Review Third Quarter 2010

Total Revenues and Other Operating Income
The  Company announced  combined total  revenues and  other operating  income of
€89.5  million,  compared  to  €94.3  million  in the third quarter of 2009. The
decrease was driven by a decline in respiratory vaccine sales.

Product  sales in the third quarter  of 2010 decreased 13% over the same quarter
in  2009 to  €72.8  million  and  represent  sales of paediatric vaccines (67%),
travel  and  endemic  vaccines  (14%),  respiratory  vaccines  (14%),  and other
products (5%).

License  revenues  were  €5.2  million  in  the  third quarter, compared to €3.8
million  in  the  third  quarter  of  2009. The  increase  is  mainly due to the
recognition of revenues from the JNJ collaboration which was signed in September
2009.

Service  fees for the quarter were €4.6 million, compared to €2.4 million in the
same  quarter of 2009. Service  fees represent revenues  for product development
activities performed under contracts with partners and licensees.

Other  operating  income  was  €6.9  million  for  the quarter, compared to €4.4
million  in  the  third  quarter  of  2009, reflecting  a  higher  level  of R&D
reimbursements and one-time transactions.

Cost of Goods Sold
Cost  of goods  sold for  the third  quarter of  2010 amounted to  €77.0 million
compared  to  €55.1  in  the  same  quarter  of  the  prior  year. €75.5 million
represents  product  costs;  and  €1.5  million  the cost of service and license
activities.

Gross  margins  were  7%, compared  to  39% in  the third quarter of 2009. Gross
margins  were significantly impacted by  the provision for Quinvaxem® inventory,
pricing  of Quinvaxem®  sales, variation  in product  mix and negative operating
variances.

Expenses
Total  expenses consisted 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 €43.6 million, representing a €19.9 million increase
over  the same  period in  2009, driven by  an increase  in R&D expenses and the
positive effect of the reversal of impairment in the third quarter of 2009.

R&D  expenses for the  third quarter amounted  to €26.8 million, representing an
increase  of  €10.3  million  versus  the  third  quarter of 2009 as R&D program
spending accelerated in line with guidance.

SG&A  expenses for the quarter  were €16.7 million compared  to €15.2 million in
the  third quarter of 2009. This increase was mainly due to higher M&S expenses,
partly as a result of the set-up of the new UK office.

Operating  loss of €31.1 million for the third quarter, compared to an operating
profit of €15.5 million in the same period of 2009.

Net Result
Net  loss of €27.0 million was reported  for the third quarter of 2009, compared
to  a net  profit of  €10.0 million  in the  third quarter of 2009. Net loss per
share  is €0.33, compared to a net profit  per share of €0.15 in the same period
of 2009.

Balance Sheet
Tangible  fixed  assets  amounted  to  €239.3  million  on  September 30, 2010.
Intangible  assets  amounted  to  €82.6  million,  including acquired in-process
research  and  development,  developed  technology,  patents and trademarks, the
value of customer and supplier relationships, and capitalized IT investments.

Investments  in  associates  and  joint  ventures  amounted to €13.5 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.
Total  equity on September 30, 2010 amounted to €773.9 million. A total of 81.7
million ordinary shares were issued and outstanding on September 30, 2010.

Cash Flow and Cash Position
Cash and cash equivalents increased by €46.6 million during the third quarter to
€292.1  million. Short  term financial  assets include  deposits with maturities
over 90 days for an amount of €52.5 million. This reduction of €47.6 million was
due  to the reclassification of longer term deposits, where the deposit maturity
was reduced to 3 month or less.

Cash  from operating  activities decreased  to €17.3  million compared  to €72.1
million  in  the  same  period  of  2009. In  the third quarter of 2009 the cash
received  from the Johnson & Johnson collaboration was included in the cash from
operating activities.

Cash  from investing activities amounted to  €29.1 million in the third quarter,
which is mainly due to reclassification of financial deposits.

Net  cash  from  financing  activities  in  the quarter amounted to €0.2 million
compared  to €235.0 million in the same  period of 2009, as the third quarter of
2009 included the 18% equity stake of Johnson & Johnson.

Notes to the Condensed Consolidated Interim Financial Statements
The  notes to  Crucell's Financial  Statements for  the nine months period ended
September 30, 2010 are available onwww.crucell.com.

About Crucell
Crucell  N.V. (NYSE  Euronext, NASDAQ:  CRXL; Swiss  Exchange: 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. In  2009 alone, Crucell  distributed more than 115 million
vaccine  doses  in  more  than  100 countries  around  the  world, with the vast
majority  of doses (97%)  going to developing  countries. Crucell is  one of the
major  suppliers of vaccines to UNICEF and the developing world. Crucell was the
first   manufacturer  to  launch  a  fully-liquid  pentavalent  vaccine.  Called
Quinvaxem®,  this innovative combination vaccine protects against five important
childhood  diseases. Over 130 million  doses have been  sold since its launch in
2006 in  more than 50 GAVI countries. With this innovation, Crucell has become a
major  partner in protecting children in developing countries. Other products in
Crucell's  core portfolio include a vaccine  against hepatitis B and a virosome-
adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such
as  an 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
Johnson  & Johnson, DSM Biologics, sanofi-aventis, Novartis, Wyeth, GSK, CSL and
Merck & Co. Crucell is headquartered in Leiden, the Netherlands, with offices in
China,  Indonesia, Italy, Korea,  Malaysia, Spain, Sweden,  Switzerland, UK, the
USA  and Vietnam.  The Company  employs over  1300 people. For more information,
please visitwww.crucell.com.


Forward-looking statements
This  press release  contains forward-looking  statements that  involve inherent
risks  and uncertainties.  We have identified a number of 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  7, 2010, in  the  section  entitled  'Risk Factors' and in our second
quarter  2010 financial  results,  as  filed  with  the  Securities and Exchange
Commission  on  August  17, 2010 in  the  section entitled 'Risk Paragraph'. The
Company   prepares   its  financial  statements  under  International  Financial
Reporting Standards (IFRS).

EGM information
Crucell will convene an Extraordinary General Meeting of Shareholders on
December 10, 2010 in Amsterdam, the Netherlands, to discuss the intended offer
of Johnson & Johnson for all outstanding shares of Crucell not already owned by
Johnson & Johnson. The statutory meeting for shareholders as required by Dutch
takeover regulations will be held in January, 2011 in Amsterdam, the Netherlands
(six business days prior to the expiration of the acceptance period of the
offer).

For further information please contact:
Oya Yavuz
Vice President Corporate Communications & Investor Relations
Tel. +31 (0)71 519 7064
[email protected]
www.crucell.com


[1] In guidance currencies = EUR/USD rate of 1.41


[HUG#1460291]





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