CRUCELL 
By Strong Quinvaxem® demand drives first quarter 2009 results.
Total first quarter revenues and other operating income increased
over 50% to ?73.7 million, compared to ?47.9 million in the same
period of 2008.
Gross margin in the first quarter improved to 45% up from 40% in Q1
2008.
Break-even compared to a net loss of ?9.0 million in Q1 2008.
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; solid cash flow.
Leiden, The Netherlands (May 6, 2009) - Dutch biopharmaceutical
company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX)
today announced its financial results for the first quarter of 2009,
based on International Financial Reporting Standards (IFRS). These
financial results are unaudited.
Highlights:
* In the first quarter of 2009 total revenues and other operating
income increased 54% to ?73.7 million, compared to ?47.9 million
in the same period of 2008. The strong quarter was driven by
significant growth in sales of the pentavalent children's vaccine
Quinvaxem®.
* Aeras and Crucell announced the start of a Phase I clinical trial
in infants of the jointly developed tuberculosis vaccine
candidate, AERAS-402/Crucell Ad35. This is the first clinical
trial designed to test this vaccine candidate in infants.
* In February 2009, the journal Science published a study that
explains why Crucell's novel anti-influenza antibody is so
effective against such a broad range of influenza virus subtypes,
including H1N1. These characteristics make the Crucell antibody
CR6261 a potentially revolutionary therapy against seasonal and
pandemic flu.
* Following the success of our rabies and flu antibody programs,
Crucell has obtained an exclusive license from Stanford
University for the development of an antibody combination against
the Hepatitis C virus.
* Our Yellow Fever vaccine Flavimun® was submitted for registration
in Switzerland in March 2009. Submission in Germany is expected
before the end of 2009.
* DSM and Crucell entered into an agreement with Bioceros B.V. to
join their Vendor Network. Under the terms of the agreement,
Bioceros will be a pre-approved cell line generation partner for
licensees of the PER.C6® cell line located in the European Union.
* DSM and Crucell announce that they have entered into an agreement
with KBI Biopharma Inc. to provide cell line generation services
of the PER.C6® cell line for licensees of the technology.
* Crucell signed a non-exclusive STAR® research and commercial
license agreement with Pennsylvania-based Centocor, Inc. for the
production of monoclonal antibodies.
* Construction of our new vaccine manufacturing facility in Korea,
which started in December 2008, is showing excellent progress.
Financial Highlights First Quarter 2009:
* Combined total revenues and other operating income for the first
quarter were ?73.7 million, compared to ?47.9 million in the same
quarter of 2008. The increase of 54% (49% in constant
currencies[1]) was primarily driven by strong sales of our
paediatric vaccines, in particular Quinvaxem®.
* License income of ?4.5 million in the first quarter, compared to
?5.2 million in the same quarter of 2008. Comparable license
revenues in Q108 were positively impacted by a milestone payment
from strategic partner sanofi pasteur for Crucell's rabies
monoclonal antibody combination.
* Gross margins were 45% in the quarter, compared to 40% in the
first quarter of 2008. Gross margins were significantly
influenced by positive currency effects, as well as production
efficiencies (i.e. improved yields and lower scrap). The positive
currency effects, which reduced the cost of goods sold in the
first quarter of the year, are expected to diminish during the
remainder of the year.
* Net profit in the first quarter of 2009 was ?0.2 million,
compared to net loss of ?9.0 million in the same quarter of 2008.
* Net cash used in operating activities in the first quarter of
2009 was ?20.1 million, compared to ?34.0 million in the same
quarter of 2008.
* Net decrease in cash and cash equivalents in the first quarter of
?34.1 million, versus ?41.4 million in the first quarter of 2008.
* Deterioration of cash flow and working capital in the first
quarter was due to build-up of paediatric vaccine inventory, in
anticipation of strong 2009 sales and due to phasing in our
accounts receivables and accounts payables.
* On April 22nd, 2009 Crucell filed its 2008 Annual Report and Form
20 F including detailed coverage of our Corporate Social
Responsibility as a company.
Key Figures First Quarter 2009:
(? million, except net result per share)
Q1 2009 Q1 2008 Change
unaudited unaudited
Total revenues and other
73.7 47.9 54% operating income
0.2 (9.0) Net profit/(loss)
0.00 (0.14) Net result per share (basic)
Cash & cash equiv.:
136.8 - March 31, 2009
171.0 - December 31, 2008
121.9 - March 31, 2008
Crucell's Chief Executive Officer Ronald Brus said:
"Last year, we significantly grew our business and made the
transition to profitability. Our strong growth in the first quarter
of 2009 demonstrates the effectiveness of our strategy for building
our global business and expanding the number of people we protect
from infectious diseases. I am very proud that Crucell's success can
be measured in human as well as financial terms.
Our 2008 Annual Report, now out, includes a new emphasis on Corporate
Social Responsibility. The detailed CSR report is our first big step
towards greater transparency about our commitment to sustainability
and making a difference to society. It's important that we reflect on
our social responsibility and talk about it in an open way.
Recently the world has been alarmed by the new influenza virus
A(H1N1) with several hundreds of human cases globally. As the
situation is evolving rapidly, Crucell stays in active dialogue with
the relevant governmental authorities and non governmental
organizations, and we are working hard to support the public health
needs where ever we can."
Product and Business Update
Product Update:
Product sales in the first quarter of 2009 amounted to ?63.1 million
and represent sales of paediatric vaccines (72%), travel and endemic
vaccines (19%), and other products (9%).
Paediatric
Sales of our paediatric vaccines showed strong growth in the first
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 first quarter of 2009 sales of our travel and endemic
portfolio were largely flat. We continue to see untapped demand and
potential for geographical expansion of our travel portfolio.
* 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
We typically have no sales in the segment of products at the
beginning of a calendar year due to normal seasonality of the flu
business.
* 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.
Recently the world has been alarmed by the new influenza virus
A(H1N1). Therefore, as an influenza vaccine manufacturer, Crucell is
in active dialogue with the relevant governmental authorities and non
governmental organizations.
While suitable actions to the situation are being decided and
implemented, Crucell is working hard to support the immediate public
health needs where possible. In response to a request from the Pan
American Health Organization, Crucell has mobilized the remaining
(limited) stocks of its 2008/2009 seasonal vaccine Inflexal® V for
supply to Mexico.
Pipeline Update:
* Flavimun® - Live Attenuated Yellow Fever Vaccine: Flavimun® was
submitted for registration in Switzerland in March 2009. Submission
in Germany is expected before the end of 2009.
* Influenza - Seasonal Flu Vaccine (FluCell collaboration with sanofi
pasteur): This seasonal influenza vaccine is being developed by
Crucell's partner sanofi pasteur, using 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 strains in high
quantities. The cell line has also been found to be commercially
scaleable to any desired scale and no problems related to the
PER.C6® cell line have been encountered to date.
* Rabies Human Monoclonal Antibody Combination (CL 184): 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 U.S. and in the Philippines. Promising Phase I data
in 2007 showed no serious adverse effects and demonstrated the
expected rabies neutralizing activity upon administration. The
rabies human monoclonal antibody combination was granted a Fast
Track designation by the FDA Department of Health and Human
Services. Under the terms of the collaboration agreement with
sanofi pasteur, Crucell will be responsible for manufacturing of
the final product and has retained exclusive distribution rights in
Europe, co-exclusive distribution rights in China and the rights to
sell to supranational organizations such as UNICEF, while sanofi
pasteur will have exclusive distribution rights for all other
territories and co-exclusive distribution rights in China. 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 our 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 ?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. Final data from
this study are expected to become available in the first half of
2009.
* An additional phase II study in healthy adults evaluating Crucell's
monoclonal antibody in combination with a rabies vaccine is
scheduled to start in India in the second quarter of 2009.
* Tuberculosis Vaccine based on AdVac®/PER.C6® Technologies:
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 vaccine
candidate at all dose levels evaluated.
Phase I:
* 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.
* A phase I study 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. Data from this study specifically indicate that two
injections of AERAS-402/Crucell Ad35 are immunogenic with an
acceptable safety profile when used with a
BCG-prime/AERAS-402/Crucell Ad35 boost interval of 84 days in BCG
vaccinated healthy adults. 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.
* An ongoing study in St. Louis, USA is evaluating a longer
prime-boost interval. The study has been fully enrolled and has
discovered no safety issues. Immunological data is expected to be
available in the first half of 2009.
* 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 is fully enrolled and now in its follow-up segment, with no
safety issues identified.
* In April 2009, a Phase I clinical trial in infants of the jointly
developed TB vaccine candidate AERAS-402/Crucell Ad35 was started
in South Africa. This is the first clinical trial designed to test
this vaccine candidate in infants. The Phase I study of
AERAS-402/Crucell Ad35 will be conducted by the South African
Tuberculosis Vaccine Initiative (SATVI) in the Western Cape region
of South Africa. The main objective of the study will be to test
the safety of the TB vaccine candidate in infants previously
vaccinated with the BCG vaccine, which is currently the only
vaccine licensed to help prevent TB.
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 is being tested in 82 adults who
have had active TB. No evidence of an unacceptable safety issue has
been found in its dose escalation design.
* Malaria Vaccine based on AdVac®/PER.C6® Technologies: 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. The study
is being carried out at two sites, Vanderbilt University in
Nashville, Tennessee and Stanford University in Palo Alto,
California. The first three cohorts have been enrolled and ongoing
safety monitoring has revealed no significant safety concerns to
date. Enrollment for the fourth and final group of volunteers is
underway. Preliminary examination of the blinded data from the
first three cohorts indicates the vaccine is immunogenic. Detailed
analysis of the data awaits completion of the fourth cohort and
unblinding of the data.
* Multivalent Filovirus (Ebola & Marburg) Vaccine based on
AdVac®/PER.C6® Technologies: In October 2008 Crucell announced that
it has secured a NIAID/NIH contract aimed at advancing the
development of Ebola and Marburg vaccines, ultimately leading to a
multivalent filovirus vaccine. The contract provides funding of up
to $30 million, with additional options that may be triggered at
the discretion of the NIH worth a further $40 million. The Phase I
study of an 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 adenovirus vectors that are able to bypass pre-existing
immunity against Ad5.
* HIV Vaccine based on AdVac®/PER.C6® Technologies: The
Investigational New Drug Application (IND) for Phase I of the trial
with Harvard Medical School (supported by the NIH) was approved by
the FDA in January 2008. In April, Crucell announced the start of a
Phase I clinical study of the novel recombinant HIV vaccine, using
adenovirus serotype 26 (rAd26) as vector, that Crucell is jointly
developing with the Beth Israel Deaconess Medical Center. The rAd26
vector is specifically designed to avoid the pre-existing immunity
to the more commonly used adenovirus serotype 5 (Ad5). The phase I
clinical study is being conducted at the Brigham and Women's
Hospital in Boston, 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 (10^11 vp/dose) is expected to be
fully enrolled by Q2 2009.
* Alternative Adenovirus Serotype Technologies: In November 2008,
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.
* Human Monoclonal Antibodies against a broad range of Influenza:
Crucell's scientists discovered a set of human monoclonal
antibodies that provides immediate protection and neutralizes the
broadest range of H5N1 strains in preclinical models. When tested
in preclinical models for prevention or treatment of a potentially
lethal H5N1 infection, this antibody 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 in terms of their value for flu
prevention and treatment. In December 2008 Crucell announced that its
monoclonal antibody had strongly outperformed the most current
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 the strain responsible for 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.
* Hepatitis C Antibody Combination: Crucell has 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 were found to
neutralize HCV across all genotypes tested and the antibodies
recognize different parts of the HCV surface protein.
* Blood Coagulation Factor VL/C: Preclinical work on this program
continues but conclusive proof of concept is not expected in the
near future.
Korean Production Facility:
Crucell announced in October 2008 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. All
parties involved have agreed on the time line and conditions of this
relocation, enabling a smooth transition to the new production
facility. Construction activities at the new site started in December
2008 and progress of the project is excellent. 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 ?50 million, with the majority of spending in
2009.
The Crucell Ambition:
In 2008, The Crucell Ambition program was rolled out throughout the
whole organization and the management board has met with more than
60% of Crucell's employees from different parts of the organization.
The Crucell Ambition is a strategic program encompassing coordinated
efforts in four priority areas, which were carefully defined after a
thorough review of Crucell's operations, objectives and potential.
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 ?30 million by the end of 2009 compared to the
2007 cost base (excluding R&D). Initial net cost savings of ?5
million were achieved in the second half of 2008 and an additional ?6
million of net cost savings was realized in Q1 2009. Savings were
predominantly achieved through improved yields, marketing and sales
efficiency gains and through savings in overhead.
The Crucell Values:
In line with The Crucell Ambition and to further strengthen the
importance of being one company, using input from the whole company,
we defined common values which embrace and underline all our work and
our behavior. The values support and strengthen our mission of
combating infectious diseases. The priority areas, which were
carefully defined after a thorough review of Crucell's operations,
objectives and potential, are: Integrity, Respect, Complementarity,
Reliability, Innovation and Passion & Drive.
Manufacturing & Licensing Agreements:
* Crucell announced a non-exclusive STAR® research and commercial
license agreement with Pennsylvania-based Centocor, Inc. for the
production of monoclonal antibodies. Financial details of the
agreement were not disclosed. [January 2009]
Vendor Network Agreements:
* DSM and Crucell announced that they have entered into an
agreement with Bioceros B.V. of Utrecht, The Netherlands to join
their Vendor Network. Under the terms of the agreement, Bioceros
will be a pre-approved cell line generation partner for licensees
of the PER.C6® cell line located in the European Union. Other
terms of the agreement were not disclosed. [January 2009]
* DSM and Crucell announce that they have entered into an agreement
with Durham, North Carolina-based, KBI Biopharma Inc. to provide
cell line generation services of the PER.C6® cell line for
licensees of the technology. With the flexible licensing
structure of the PER.C6® technology, KBI Biopharma, a leader in
contract biopharmaceutical development, can provide services
during the crucial early phase of development for licensees.
[March 2009]
Patents:
In Q1 2009 Crucell was granted a total of 10 patents, including
patents for:
* PER.C6® protein expression technology, in China and the U.S.
* Improvements in influenza virus isolation using PER.C6®
technology, in the U.S.
* Improvements in PER.C6® expression technology, in Australia
* Virus purification technology, in Australia
* AdVac®-based malaria vaccines, in India
Financial Review
Total Revenues and Other Operating Income
Total revenues and other operating income was ?73.7 million for the
first quarter of 2009, an increase of 54% compared to the same
quarter of 2008 (49% in constant currencies[1]). The increase was
primarily driven by strong sales of our paediatric vaccines, in
particular Quinvaxem®.
Product sales in the first quarter of 2009 amounted to ?63.1 million
and represent sales of paediatric vaccines (72%), travel and endemic
vaccines (19%), and other products (9%).
License revenues were ?4.5 million in the first quarter, a decrease
of ?0.7 million compared to the same quarter of 2008. License
revenues in Q108 were positively impacted by a milestone payment for
Crucell's rabies monoclonal antibody combination. License revenues
consist of initial payments from new contracts as well as milestones
and other payments on existing contracts.
Service fees for the quarter were ?2.9 million, compared to ?2.0
million last year. Service fees represent revenues for product
development activities performed under contracts with partners and
licensees.
Other operating income was ?3.2 million for the quarter, compared to
?5.1 million in the first quarter of 2008.
Cost of Goods Sold
Cost of goods sold for the first quarter of 2009 amounted to ?38.8
million, ?36.1 million of which represents product costs and ?2.6
million the cost of service and license activities.
Gross margins were 45% in the quarter, compared to 40% in the first
quarter of 2008. Gross margins were significantly influenced by
positive currency effects, as well as production efficiencies (i.e.
improved yields and lower scrap). The positive currency effects,
which reduced the cost of goods sold in the first quarter of the
year, are expected to diminish during the remainder of the year.
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 first quarter were ?32.5 million,
representing a ?6.5 million increase over the same period in 2008
(?26.0 million, which included a ?5.2 million reversal of
impairment).
R&D expenses for the first quarter amounted to ?15.3 million, which
represents a ?0.5 million decrease versus the first quarter of 2008.
SG&A expenses for the quarter were ?17.2 million, which represents a
?1.9 million increase versus the first quarter of 2008. This was
largely due to higher commission expenses and option costs.
Net financial income and expenses in the first quarter were minus
?0.1 million.
The company recorded a ?2.4 million income tax charge in the first
quarter mainly as a result of taxable profits in Korea and Sweden.
Net Result
Net profit of ?0.2 million was reported in the first quarter of 2009
versus a net loss of ?9.0 million in the same period of 2008. Net
results in Q1 2008 were positively affected by a partial reversal of
?5.2 million on the impairment of a production facility in Bern
(Switzerland). Net result per share in the first quarter of 2009 is
?0.00, compared to a net loss per share of ?0.14 in the first quarter
of 2008.
Balance Sheet
Tangible fixed assets amounted to ?151.9 million on March 31, 2009.
Intangible assets amounted to ?74.4 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 ?9.9 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 March 31, 2009 amounted to ?459.5 million. A total of
66.5 million ordinary shares were issued and outstanding on March 31,
2009.
Cash Flow and Cash Position
Cash and cash equivalents decreased by ?34.1 million in the first
quarter to ?136.8 million. Deterioration of cash flow and working
capital in the first quarter was due to build-up of paediatric
vaccine inventory, in anticipation of strong 2009 sales and due to
phasing in our accounts receivables and accounts payables.
Net cash used in operating activities in the first quarter of 2009
was ?20.1 million. Net cash used in investing activities in the
first quarter amounted to ?7.3 million. Net cash used in financing
activities in the first quarter amounted to ?4.5 million.
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.
* Furthermore, the Company expects solid cash flow despite
significant investments in the new facility being built in Korea.
These investments are expected to total approximately ?50
million, with the majority of spending in 2009.
* Crucell does not expect its business to be affected by the
difficult markets envisaged in 2009.
Phasing: We expect revenues throughout 2009 to be phased similarly to
those in 2008. The phasing of cash flow and working capital are
expected to significantly deteriorate in the first half of 2009,
which is normal due to the seasonality of our business. We build
inventory in the first half of the year to sell our respiratory and
travel vaccine products in the second half of the year.
Annual Report
Crucell N.V. has finalized the Annual Report and Form 20-F for the
year ended December 31, 2008. We filed our 2008 Annual Report and
Form 20-F with the U.S. Securities and Exchange Commission and
published our Statutory Annual Report for the year 2008 on April 22,
2009.
The consolidated balance sheet of Crucell N.V. as of March 31, 2009,
the related consolidated statements of operations and consolidated
statements of cash flows for the period ended March 31, 2009 and all
quarterly information as presented in this press release is
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 U.S. 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 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 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 Switzerland, Spain, Italy, Sweden, Korea and the U.S.
The Company employs over 1000 people. For more information, please
visit www.crucell.com.
Financial Calendar
5 June 2009 Annual General Meeting of Shareholders
11 August 2009 Q2 Results 2009
3 November 2009 Q3 Results 2009
9 February 2010 Q4 Results 2009
For further information please contact:
Crucell N.V.
Oya Yavuz
Vice President
Corporate Communications & Investor Relations
Tel. +31-(0)71-519 7064
ir@crucell.com
www.crucell.com
________________________________________
[1] Constant currencies = EUR/USD rate of 1.35
[2] Guidance currency = EUR/USD rate of 1.35
This announcement was originally distributed by Hugin. The issuer is
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http://hugin.info/132631/R/1311542/303765.pdf
Copyright © Hugin AS 2009. All rights reserved.CRUCELL : Announces First Quarter 2009 Results
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