Crucell Announces Record Revenues and Profits for Full Year 2009
Total revenues and other operating income increased 26% to EUR358.0 million.
Operating profit increased more than four-fold to EUR39.0 million.
Net profit increased 68% to EUR23.9 million.
Undiluted EPS increased 55% to EUR0.34.
Year-end cash and short-term liquidities EUR428.0 million.
2010 guidance: Use continued strong operating cash flow to accelerate
product development. R&D spending to increase by over one-third, while
maintaining a healthy operating profit.
Revenues and other operating income[1] broadly in line with 2009.
Leiden, the Netherlands (February 9, 2010) - Dutch biopharmaceutical company
Crucell N.V. (NYSE Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announced
its financial results for the fourth quarter and full year of 2009, based on
International Financial Reporting Standards (IFRS). These financial results are
unaudited.
Business Highlights 2009:
· Strategic agreement, worth over EUR1 billion, for revolutionary
influenza antibody research signed with Johnson & Johnson (JNJ) in September
2009. Crucell's scientists discovered human monoclonal antibodies that
cross-neutralize influenza viruses of different subtypes (including H5 and H1)
and that provide immediate protection against the broadest range of flu strains
in pre-clinical models.
· National Institutes of Health (NIH) awarded up to $69.1 million for
novel influenza antibody research in August 2009. Initial 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.
· Detailed positive results of the Phase II Philippines study of rabies
monoclonal antibody combination were presented at the 20(th) Rabies in the
Americas (RITA) Conference in Canada in October 2009.
· Promising preliminary results of the HIV vaccine Phase I study were
presented in October 2009 at the AIDS Vaccine Conference 2009 in France, showing
that this HIV candidate vaccine is safe and immunogenic.
· In July 2009 Crucell announced the collaboration with the PATH Malaria
Vaccine Initiative (MVI) and the United States Agency for International
Development (USAID) Malaria Vaccine Development Program (MVDP) to accelerate
development of its malaria vaccine.
· In May 2009, Crucell announced that, following the success of
Crucell's rabies and flu antibody programs, Crucell obtained an exclusive
license from Stanford University for the development of an antibody combination
against the hepatitis C virus.
· In August 2009 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 (2010-2012). The new awards are in
addition to the $500 million obtained over the tender period 2007-2009.
· Construction of the new vaccine manufacturing facility in Incheon,
Korea, has progressed in rapid pace and technical completion has been achieved
in 13 months. First test runs are planned for the second quarter of 2010.
· Our partner Adimmune successfully started production of influenza
vaccines in Taiwan and is a promising future supplier of flu antigens for us.
· In 2009 Crucell signed 12 new license/vendor agreements, including
agreements with Centocor Inc., Momotaro-Gene Inc., Patrys Ltd., TapImmune Inc.,
Calmune Corporation, Cangene and Vivante GMP Solutions. Vendor Network
Agreements were signed with Bioceros B.V. and KBI Biopharma Inc.
Financial Highlights 2009:
* Combined total revenues and other operating income were EUR358.0 million,
compared to EUR283.3 million in 2008. The increase of 26% was mainly driven by
strong sales of our paediatric vaccines. At guidance currency EUR/USD rate
of 1.35, the total revenue growth was 29%. This is primarily due to the US
dollar depreciating versus the Euro.
* Product sales were EUR304.4 million, a 35% increase compared to 2008,
representing sales of paediatric vaccines (59%), travel and endemic vaccines
(18%), respiratory vaccines (12%) and other products (11%).
* Gross margins of 42%, compared to 45% in 2008. Currency movements and the
timing of milestones impacted margins.
* The Company achieved operating profit of EUR39.0 million for the full year,
compared to EUR7.4 million operating profit in 2008.
* The consolidated effective income tax rate was 37% for 2009. Income taxes
for the full year were EUR14.0 million. The effective tax rate is relatively
high due to an operating loss in the Netherlands as a result of R&D
expenses, for which no tax benefit is recognized.
* Crucell achieved a net profit of EUR23.9 million, compared to EUR14.3 million in
2008. Net profit per share of EUR0.34, compared to EUR0.22 in 2008.
* As part of the strategic collaboration with JNJ, the company issued 14.6
million new ordinary shares to JNJ for an aggregate purchase price of EUR301.8
million. This included a premium of EUR69 million classified as deferred
income.
* Operating cash flow of EUR76.9 million for the year, compared to minus EUR0.3
million in 2008.
* Cash used in investing activities amounted to EUR154.4 million, which includes
a long term deposit of EUR100.0 million with a maturity of over 3 months, to
take advantage of higher yields on longer term deposits.
* Net cash from financing activities for the full year was EUR231.5 million,
compared to EUR16.6 million in 2008, driven by issuance of shares to JNJ.
* Cash and cash equivalents increased by EUR156.9 million during the year to
EUR327.8 million at year-end 2009.
Key Figures:
(EUR million, except net result per share)
--------------------------------------------------------------------------------
Fourth Quarter Full Year
--------------------------------------------------------------------------------
2009 2008 Change 2009 2008 Change
unaudited unaudited unaudited unaudited
--------------------------------------------------------------------------------
Total revenues and other
111.3 93.7 19% operating income 358.0 283.3 26%
18.0 11.9 52% Operating profit 39.0 7.4 425%
15.6 18.9 (18)% Net profit 23.9 14.3 68%
Net result per share
0.19 0.29 (34)% (basic) 0.34 0.22 55%
Crucell's Chief Executive Officer Ronald Brus said:
"The key event of the year was the partnership agreement we signed with Johnson
& Johnson (JNJ). This partnership, with a total deal value of over
EUR1 billion, included a payment of over EUR300 million, mainly related to an equity
investment of 18%. The partnership with JNJ provides us with additional R&D
funding and enables us to further accelerate and expand our product development.
In 2010 and onwards we have a responsibility to make the most of these
opportunities.
"Our business is stronger than ever and in 2009 we achieved a solid overall
revenue growth of 26%, driven by a 35% increase in vaccine sales. With a clear
strategy for long-term growth and even more focus on research and development, I
am very proud that we significantly improved profitability in 2009 and together
with a healthy balance sheet and a strong year-end cash position, we were able
to end the year on a high.
"Our world-class vaccine production plant in Seoul, Korea, is being constructed
at record pace. This allows us to efficiently produce high volumes of vaccines
in Asia. Our partner Adimmune has also successfully started production of
influenza vaccines in Taiwan and is a promising future supplier of flu antigens
for us.
"Furthermore, in 2009 we made great progress in terms of global integration,
improving performance and increasing accountability-all with the ultimate aim of
increasing the impact Crucell has on human health. These achievements form a
solid foundation on which to build our future."
Product Sales Update:
Product sales in the full year of 2009 increased 35% over the same quarter in
2008 to EUR304.4 million and represent sales of paediatric vaccines (59%), travel
and endemic vaccines (18%), respiratory vaccines (12%) and other products (11%).
In September 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. Distribution of the travel vaccines (Epaxal(®), Vivotif(®) and
Dukoral(®)) has started and is progressing well. Distribution of the influenza
vaccine Inflexal(®) V will start in the flu season of 2010.
In November 2009 Crucell announced the launch of the global Crucell brand, a
consistent identity for its worldwide activities and products. The rebranding is
designed to promote recognition of the Crucell name and what it stands for:
bringing meaningful innovation to global health, with a focus on combating
infectious diseases. The establishment of a strong global brand will
significantly support this mission.
Research & Development:
· Flavimun(® )- Live Attenuated Yellow Fever Vaccine (Phase III):
Flavimun(®) was submitted for registration in Switzerland in March 2009.
Submission in Germany is imminent.
· Influenza - Seasonal Influenza Vaccine: This seasonal influenza
vaccine is being developed by Sanofi Pasteur, using Crucell's PER.C6(®)
technology. 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.
· Influenza - Human Monoclonal Antibodies against a broad range of
Influenza strains (pre-clinical): Crucell's scientists discovered human
monoclonal antibodies that cross-neutralize influenza viruses of different
subtypes including H5 and H1 and that provide immediate protection against the
broadest range of H5N1 and H1N1 strains in pre-clinical models. The most
powerful of these antibodies, mAb CR6261 was shown to prevent death and cure
disease in pre-clinical models for prevention or treatment of a potentially
lethal H5N1 and H1N1 infections and to strongly outperform the anti-influenza
drug oseltamivir (Tamiflu) in terms of its value for flu prevention and
treatment. The characterization of the antibody was described in the online
journal PLoS ONE on December 16, 2008 and the journal Science on February
4, 2010.
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 Influenza monoclonal antibodies providing funding of up to
$40.7 million, with additional options worth a further $28.4 million, bringing
the potential total amount to $69.1 million.
In September 2009 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. In addition the
strategic collaboration involves three 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.
· 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. CL184 is designed for the post-exposure prophylaxis against rabies
in combination with rabies vaccine. Under the terms of the collaboration
agreement 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.
The completion of two Phase II studies in US and Philippines respectively has
triggered milestone payments from Sanofi Pasteur as part of the total eligible
amount of EUR66.5 million.
In June 2009, Crucell announced the results of the Philippines study, which
showed that CL184 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. Results of this study have
been presented at the XX Rabies in the Americas RITA conference in Quebec,
Canada on 20 October 2009.
Crucell is planning to start an additional Phase II study in India in the second
quarter of 2010 to collect safety and neutralizing activity data of the CL184
antibody in combination with the vaccine in a simulated rabies post-exposure
prophylaxis setting.
* Tuberculosis Vaccine(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:
· The first Phase II study of AERAS-402/Crucell Ad35, started in October
2008, is being conducted by the University of Cape Town Lung Institute, South
Africa in conjunction with the South African Tuberculosis Vaccine Initiative. In
this dose escalation study in adults who have had active TB, no evidence of an
unacceptable safety issue has been found in the 72 subjects enrolled to date.
Preliminary data indicate that the candidate vaccine induces CD8-cell immune
responses in patients who have completed TB treatment.
Phase I:
· The US Phase I trial in healthy adults not previously immunized with
the traditional TB vaccine, Bacille Calmette-Guérin (BCG), has been completed
and demonstrated that the candidate vaccine is safe in this population.
· Results of a second study with the candidate vaccine in South Africa
showed CD8 T 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 boost doses administered at three to six
month intervals after BCG priming in healthy adults have been completed. Data
from these studies showed that two injections of the candidate vaccine are
immunogenic, with an acceptable safety profile, when used in combination with a
BCG-prime in 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. A follow-up study conducted in the USA in healthy
adults showed that injections with up to 10(11) vpu/ml of the candidate vaccine
had an acceptable safety profile.
· In October 2008, a Phase I clinical trial to test the safety of the
candidate vaccine in BCG-vaccinated adults with or without latent tuberculosis
has been completed, with ongoing analysis and no safety issues identified. The
study is being conducted by the KEMRI/Walter Reed Project-Kisumu at their
Kombewa Clinical Trials Center near Kisumu, in western Kenya.
· In April 2009, a Phase I clinical trial was started in South Africa
with the main objective to test the safety of the candidate vaccine in infants
previously vaccinated with BCG vaccine, currently the only vaccine licensed to
help prevent TB. This first clinical trial designed to test the candidate
vaccine in infants is being conducted by the South African Tuberculosis Vaccine
Initiative (SATVI) in the Western Cape region of South Africa. The study is
fully enrolled and dosing is ongoing. No safety issues have been identified to
date.
· In January 2010, a Phase I clinical trial was initiated in Portland,
Oregon. This trial is using a known immunogenic regimen of BCG and the candidate
vaccine in healthy adults, followed by collection of large numbers of immune
cells, for more detailed analysis of the immune response to AERAS-402/Crucell
Ad35.
* Malaria Vaccine(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. In December 2009 boost
vaccinations for the final group of volunteers have been completed. Ongoing
safety monitoring has revealed no significant safety concerns to date.
Preliminary examination of the blinded data from the first four cohorts
indicated that the vaccine is immunogenic. Detailed analysis of the data is
ongoing and unblinding is expected in the second quarter of 2010.
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 Plasmodium falciparum. 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(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, worth a further $40 million. The
Phase I study of an adenovirus 5 (Ad5) and PER.C6(®) -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(Phase I): In October 2009 preliminary results of a Phase I study
with a novel recombinant HIV vaccine, using adenovirus serotype 26 (rAd26)
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. The rAd26 vector, that Crucell is jointly developing with the
Beth Israel Deaconess Medical Center, 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.
* Hepatitis C Human Monoclonal Antibodies(Pre-clinical): In August 2009
Crucell obtained an exclusive license from Stanford University (Palo Alto,
California) for the development of antibodies 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.
Building Development Capability:
To strengthen Crucell's capabilities to deliver on its pipeline, the company
hired over 120 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 US.
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 second quarter 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 EUR50 million,
with the majority of spending having been made 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 was targeting
savings of EUR30 million by the end of 2009 compared to the 2007 cost base
(excluding R&D). This has been well achieved with the program ultimately
delivering just over EUR30 million in run-rate savings at the end of 2009. Savings
were predominantly achieved through improved yields, marketing and sales
efficiency gain, and savings in overhead.
Manufacturing & Licensing Agreements:
* Crucell today announces an expansion of the PER.C6(®) research license
agreement with Canada-based Cangene to include the development of additional
antibodies by Cangene. Financial details of the agreement were not
disclosed. [September 2009].
* Crucelltoday announces a patent license and a vendor network manufacturing
service license agreement with US-based Vivante GMP Solutions. The patent
license agreement grants Vivante a worldwide, non-exclusive license of
intellectual property to conduct development and manufacture using Crucell's
adenoviral-based patent portfolio. The vendor network manufacturing service
license agreement grants Vivante a non-exclusive license to utilize
Crucell's PER.C6(®) cell line in the manufacture of gene therapy and vaccine
products for Vivante's clients through Phase 1 clinical trials. Financial
details of the agreement were not disclosed. [October 2009].
Patents:
In Q4 2009 Crucell was granted a total of 93 patents, including patents for:
* Aspects of PER.C6(®) cell lines and recombinant adenovirus technology, in
Europe
* Aspects of PER.C6(®) protein expression technology, in Europe and in the
U.S.
* Aspects of AdVac(®) technology, in Europe and in Japan
* Improvements in influenza virus isolation using PER.C6(®) technology, in
China
* Aspects of improved adenoviral AdVac(®) vectors, in Europe
* Elements of STARTM technology, in Australia
* Improved methods for quantifying influenza antigens, in New Zealand and in
the U.S.
* Aspects of adenovirus manufacturing technology, in Europe
Post Balance Sheet Events:
* Crucell today announces a non-exclusive HER96 license agreement with
France-based Transgene for use of this technology in the area of infectious
diseases. Financial details of the agreement were not disclosed. [January
2010]
* Crucell today announces a non-exclusive, worldwide PER.C6(®) license
agreement with the Cancer Research UK Centre, School of Cancer Sciences,
University of Birmingham to manufacture, use and develop an adenovirus-based
gene therapy product for the treatment and/or prophylaxis of prostate
cancer, limited to performing Phase I clinical studies. Financial details of
the agreement were not disclosed. [January 2010]
Financial Review Fourth Quarter 2009
Total Revenues and Other Operating Income
Total revenues and other operating income amounted to EUR111.3 million for the
fourth quarter of 2009, an increase of 19% compared to the same quarter of
2008. The increase of 19% was driven by the strong sales of Quinvaxem(®) and
contract manufacturing product sales.
Product sales in the fourth quarter of 2009 increased 19% over the same quarter
in 2008 to EUR91.2 million and represent sales of paediatric vaccines (62%),
travel and endemic vaccines (15%), respiratory vaccines (13%) and other products
(10%).
License revenues were EUR11.3 million in the fourth quarter, an increase of EUR2.2
million compared to the fourth quarter of 2008.
Service fees for the quarter were EUR2.9 million, compared to EUR4.0 million in the
same quarter of 2008. Service fees represent revenues for product development
activities performed under contracts with partners and licensees.
Other operating income was EUR6.0 million for the quarter, compared to EUR4.1
million in the fourth quarter of 2008.
Cost of Goods Sold
Cost of goods sold for the fourth quarter of 2009 amounted to EUR56.2 million.
EUR54.1 million represents product costs; and EUR2.1 million the cost of service and
license activities.
Gross margins were 47%, compared to 50% in the fourth quarter of 2008. We saw
some pressure on margins as a result of exchange rates, which affected our
product sales and cost of goods sold.
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 fourth quarter were EUR37.1 million, similar to the same period in 2008.
SG&A expenses for the quarter were EUR13.8 million compared to EUR17.7 million in
the fourth quarter of 2008. This reduction was mainly due to lower selling
expenses.
Operating profit was EUR18.0 million in the fourth quarter of 2009 compared to
EUR11.9 million operating profit in the same quarter of 2008. Operating profit was
positively affected by the increase of revenues and other operating income.
The company recorded a EUR4.8 million income tax charge in the fourth quarter of
2009, mainly due Korea. The consolidated effective income tax rate was 24% in
the fourth quarter of 2009.
Net Result
Net income of EUR15.6 million was reported in the fourth quarter of 2009 versus a
net income of EUR18.9 million in the same quarter of 2008. Net result per share in
the fourth quarter of 2009 is EUR0.19, compared to a net result per share of EUR0.29
in the fourth quarter of 2008.
Balance Sheet
Investments in associates and joint ventures amounted to EUR11.4 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 December 31, 2009 amounted to EUR738.3 million. A total of 81.4
million ordinary shares were issued and outstanding on December 31, 2009.
Cash Flow and Cash Position
Cash and cash equivalents increased by EUR16.2 million in the fourth quarter to
EUR327.8 million.
Net cash from operating activities in the fourth quarter was EUR31.7 million, down
from EUR61.5 million in the same quarter of 2008. This decrease was a result of a
higher accounts receivable balance resulting from higher revenues.
Cash used in investing activities amounted to EUR18.9 million, which includes the
investment in the new production facility in Korea.
Net cash from financing activities in the fourth quarter was EUR1.3 million,
compared to EUR9.4 million in the same quarter of 2008. In 2008 the amount
included the flexible facility for the construction of the new site in Korea.
Change in accounting policy
As of January 1, 2009, Crucell changed its accounting policy of recognizing
actuarial gains and losses for its defined benefit pensions plans. The new
policy requires that all actuarial gains and losses are recognized in 'other
comprehensive income' in the period which they occur. Prior to this change all
actuarial gains and losses arising from experience-based adjustments and changes
in actuarial assumptions were accounted for in line with the 'corridor' method,
which allowed deferral of these results. The new policy provides more relevant
and timely information as all transactions and events of a defined benefit
postretirement plan are recognized in the period in which they occur.
Comparative amounts were adjusted as if the new accounting policy had always
been applied.
Annual Report
Crucell N.V. is currently finalizing the financial statements for the year ended
December 31, 2009. We expect to be able to file our 2009 Annual Report on Form
20-F with the U.S. Securities and Exchange Commission as well as publish our
Statutory Annual Accounts for the year 2009 before the end of April 2010. The
consolidated balance sheet of Crucell N.V. as of December 31, 2009, the related
consolidated statements of operations and consolidated statements of cash flows
for the year ended December 31, 2009, and all quarterly information as presented
in this press release are unaudited.
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. (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. 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 uniquePER.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
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 .
[1] In guidance currencies = EUR/USD rate of 1.41
Financial Calendar
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/FY Results 2010
For further information please contact Crucell:
Oya Yavuz
Vice President Corporate Communications & Investor Relations
Tel. +31 (0)71 519 7064
ir@crucell.com
www.crucell.com
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[1] In guidance currencies = EUR/USD rate of 1.41
[HUG#1381983]
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