2009-11-03 07:53:03 -
London, November , 03, 2009
Total revenues and other operating income increased by 15% to €94.3
million.
Operating profit of €15.5 million versus €9.6 million in Q3 2008.
Quarter-end cash and short-term liquidities of €411.9 million.
Undiluted EPS of €0.15 for the quarter.
2009 full year guidance reiterated: total revenues and other
operating income expected to grow 20% in constant currencies ;
operating profit for 2009 expected to improve significantly compared
to 2008; strong cash position.
Leiden, the Netherlands (November 3, 2009) - Dutch biopharmaceutical
company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX)
today announced its financial results for the third quarter of 2009,
based on International Financial Reporting Standards (IFRS). These
financial results are unaudited.
Highlights:
* In the third quarter of 2009 total revenues and other operating
income increased by 15% to €94.3 million, compared to €82.1
million in the same quarter of 2008. The increase was driven by a
robust 28% growth in product sales and in particular growth of
our paediatric and respiratory vaccines.
* In December 2008, Crucell announced the discovery of a new class
of human monoclonal antibodies (mAbs) with the unprecedented
ability to combat a broad range of influenza virus strains[1].
This breadth of protection opens up the new possibility of
developing a universal means of influenza control, solving the
key challenge in influenza prevention and treatment: the ease
with which influenza viruses mutate, leading to new seasonal
strains every year, periodic outbreaks of pandemic strains, and
the emergence of drug-resistant viruses.
* The exciting therapeutic potential of this discovery attracted
the attention of global leaders in healthcare innovation, which,
in September 2009, resulted in a strategic collaboration between
Crucell and Johnson & Johnson (JNJ). This collaboration focuses
on the discovery, development and commercialization of monoclonal
antibodies and vaccines for the treatment and prevention of
influenza and other infectious and non-infectious diseases.
* The agreement with JNJ, with a potential deal value of over €1
billion, also includes an 18% equity investment in Crucell at a
premium of 30% as well as significant milestones over the
development period of the innovation programs. JNJ will hold
commercialization rights for products resulting from the
collaborations in all countries throughout the world with the
exception of the European Union, certain additional European
countries and supranational organizations, where Crucell will
retain commercialization rights. Additionally Crucell holds all
bulk manufacturing rights.
* The strategic collaboration with JNJ follows the announcement in
August 2009 of an award to Crucell from the National Institute of
Allergy and Infectious Diseases (NIAID), part of the US National
Institutes of Health (NIH). The award was designed to support
early development of Crucell's mAbs for the treatment of seasonal
and pandemic influenza. The award provides funding of up to $40.7
million, with additional options that may be triggered at the
discretion of the NIH worth a further $28.4 million, bringing the
potential total amount to $69.1 million.
* Crucell announced $300 million worth of new awards from a large
supranational organization for supplies of Quinvaxem®, the first
portion of the new 3-year tender period. The new awards are the
largest ever received by Crucell and cover the period 2010-2012.
With only half of the original tender volume awarded to date the
initial amount of $300 million is expected to grow further over
the three year period. The new awards are in addition to the $500
million obtained over the tender period 2007-2009. During the
first tender round in 2006, Crucell initially received an award
of $230 million (Dec 2006) and received additional incremental
awards of $130 million and $140 million in May and September,
2008, respectively.
* In line with Crucell's strategy to increase its market share and
cost efficiency, the company announced the start of its own
dedicated marketing and sales organization in the United Kingdom.
The acquisition of an experienced team further strengthens
Crucell's vaccine sales position in one of the largest vaccine
markets in Europe.
* Detailed positive results of the Phase II Philippines study of
Crucell's rabies monoclonal antibody combination (CL 184) were
presented at the XX Rabies in the Americas (RITA) Conference in
Quebec, Canada. The start of the third phase II clinical study in
India is imminent.
* Promising preliminary results of the Phase I study of Crucell's
HIV vaccine were presented at La Conférence AIDS Vaccine 2009 in
Paris, France, showing that this HIV candidate vaccine is safe
and immunogenic.
* Crucell announced that the PANFLUVAC consortium consisting of
eight European research partners, which includes Crucell,
completed the first stage of their phase I clinical trial in
healthy volunteers, using a virosomal vaccine against A/H5N1
influenza.
* Crucell signed three new license agreements, which includes
agreements with Australia-based Patrys Ltd., US-based TapImmune
Inc. and US-based Calmune Corporation.
* Construction of the new vaccine manufacturing facility in Korea,
which started in December 2008, is progressing well. First test
runs are planned for the first half of 2010.
Financial Highlights:
* Combined total revenues and other operating income for the third
quarter were €94.3 million, compared to €82.1 million in the same
quarter of 2008. The increase of 15% was mainly driven by strong
sales of paediatric and respiratory vaccines. Travel and endemic
vaccines also showed solid growth due strong sales of Epaxal®,
despite the impact of reduced travel from the economic crisis.
* In line with expectations, gross margins were 39% in the quarter,
compared to 50% in the same period in the prior year. The timing
of development milestone payments from partners significantly
influence margins and profitability in the period in which they
are recognized. The third quarter of 2008 included €6.0 million
milestone payments. The remaining drop in margins is due to
unfavorable movement of the US Dollar versus the Euro.
* The Company achieved operating profit of €15.5 million in the
third quarter of 2009 compared to €9.6 million operating profit
in the same quarter of 2008. Operating profits were positively
affected by a €8.1 million impairment reversal of two
state-of-the-art buildings in Bern (Switzerland). The buildings
were impaired in the fourth quarter of 2006 as there was no
direct use for them. The buildings are now being used as
development production sites for Epaxal® (hepatitis A) and
tuberculosis vaccines. The buildings have been adapted to the
specific needs of the development programs, which will avoid
major spending in the construction of new development
facilities.
* As part of the strategic collaboration with JNJ, the company sold
14.6 million newly issued ordinary shares to JNJ for an aggregate
purchase price of €301.8 million. This included a premium of
€69.5 million classified as deferred income, which will be
amortized in the coming years.
* Income taxes were €4.6 million in the third quarter, mainly due
in Switzerland, Spain and Korea. The consolidated effective
income tax rate was 32% in the third quarter of 2009. The
consolidated profit before tax was reduced by a significant
operating loss in the Netherlands as a result of R&D expenses for
which no tax benefit is recognized.
* Net cash from operating activities in the third quarter improved
significantly to €72.1 million, up from minus €9.9 million in the
same quarter of 2008. This was driven by the upfront payment of
JNJ for participation in Crucell's development programs.
* Cash used in investing activities amounted to €118.0 million,
which includes a long term deposit of €100.0 million with a
maturity of over 3 months, to take advantage of higher yields on
longer term deposits.
* Net cash from financing activities in the third quarter was
€235.0 million, compared to €11.3 million in the same quarter of
2008. This increase reflects the cash proceeds from the issuance
of shares to JNJ.
* Cash and cash equivalents at the end of the third quarter of
€311.6 million, versus €171.0 million at year-end 2008.
Key Figures:
(€ million, except net result per share)
Third Quarter Nine months ended September
30
2009 2008 Change 2009 2008 Change
unaudited unaudited Unaudited unaudited
Total revenues
and other
operating
94.3 82.1 15% income 246.7 189.6 30%
Operating
15.5 9.6 62% profit/(loss) 21.0 (2.5) -
Net
10.0 12.8 (22)% profit/(loss) 8.4 (3.1) -
Net result per
share
0.15 0.19 (21)% (basic) 0.13 (0.05) -
Crucell's Chief Executive Officer Ronald Brus said:
"The recently announced collaboration with Johnson & Johnson - the
world's largest healthcare company - has a potential deal value of
over €1 billion and reflects the innovative strength of our company.
It represents an important validation of the promise of our new class
of broadly protective anti-influenza antibodies. The immediate focus
of this exciting collaboration will be the development and
commercialization of a universal monoclonal antibody product
(flu-mAb) for the prevention and treatment of any type of influenza
strain. In addition, we will receive a significant amount of
potential milestones throughout the development period as well as
royalty payments upon commercialization of the products, whilst
retaining commercialization rights for the European Union, certain
additional European countries and supranational organizations.
"Over the past few years we have made great strides in building on
our innovation and excellence in the global fight against infectious
diseases. We have been able to accelerate our product sales
significantly and expand our promising R&D programs. Our researchers
focus on the discovery and development of much-needed solutions for
major threats to human health, resulting in a strong pipeline of
candidate products with the potential to revolutionize the fight
against diseases such as influenza, rabies, malaria and tuberculosis.
"Crucell is becoming stronger and more effective as a global force
in healthcare. Our goal has been, and remains, to strengthen our
ability to bring meaningful innovation to global health by actively
investing in our pipeline and by building on our existing knowledge
of the vaccine and antibody markets in infectious disease."
Product Sales Update:
Product sales in the third quarter of 2009 increased 28% over the
same quarter in 2008 to €83.7 million and represent sales of
paediatric vaccines (46%), travel and endemic vaccines (14%),
respiratory vaccines (31%) and other products (9%).
Crucell started its own dedicated marketing and sales organization in
the United Kingdom by acquiring an experienced team, which will
further strengthen its vaccine sales position in one of the largest
vaccine markets in Europe. The UK team will market and sell Epaxal®,
Vivotif®, Dukoral® and Inflexal® V. Distribution of the travel
vaccines has started, distribution of the influenza vaccine will
start in 2010.
Paediatric
Sales of our paediatric vaccines, continued to show good growth in
the third quarter 2009, particularly driven by Quinvaxem®.
* Quinvaxem®: Fully liquid pentavalent vaccine against five
important childhood diseases.
* Hepavax-Gene®: Recombinant vaccine against hepatitis B.
* Epaxal® Junior: Paediatric dose (0.25mL) of Epaxal®, the only
aluminum-free vaccine against hepatitis A for use in children.
* MoRu-Viraten®: Vaccine for protection against measles and rubella
(for all age groups).
Travel and Endemic
In the third quarter of 2009, sales of our travel and endemic
portfolio showed solid growth. Our travel portfolio has seen limited
impact from the economic crisis as we were able to compensate sales
declines with good uptake of our hepatitis A vaccine Epaxal® in new
territories.
* Epaxal®: Aluminum-free vaccine against hepatitis A.
* Vivotif®: Oral vaccine against typhoid fever.
* Dukoral®: Oral vaccine against cholera and diarrhea caused by
ETEC (enterotoxigenic E. coli).
Respiratory
The third quarter of 2009 showed solid growth, compared to the same
quarter of 2008 of our flu vaccine Inflexal® V. Sales of Inflexal® V
were particularly strong, due to the global strong demand for flu
products. Shipments of Inflexal® V were mainly phased into the third
quarter and thus earlier than sales in 2008.
* Inflexal® V: A virosomal adjuvanted vaccine against influenza
(for all age groups). Due to the seasonality of the product, we
build inventory in the first half of the year to sell flu
vaccines in the second half of the year.
Research & Development:
* Flavimun® - Live Attenuated Yellow Fever Vaccine (Phase III):
Flavimun® was submitted for registration in Switzerland in March
2009. Submission in Germany is expected within the next few
months.
* Influenza - Seasonal Flu Vaccine (Phase II; FluCell collaboration
with Sanofi Pasteur): This seasonal influenza vaccine is being
developed by Sanofi Pasteur, using Crucell's PER.C6® technology.
Phase II testing of the cell-based influenza vaccine was
initiated in the USA in November 2007. In the third quarter of
2008, Crucell received a milestone payment from Sanofi Pasteur
for progress of the Phase II trials involving healthy adult
volunteers in the USA. The trials focus on the safety profile and
immunogenicity of the cell-based vaccine. All data collected so
far confirm that the PER.C6® cell line supports the growth of all
flu virus strains in high quantities. The cell line has also been
found to be commercially scalable to any desired scale and no
problems related to the PER.C6® cell line have been encountered
to date.
* Human Monoclonal Antibodies against a broad range of Influenza
strains (Preclinical): Crucell's scientists discovered a set of
human monoclonal antibodies that provide immediate protection and
neutralize the broadest range of H5N1 strains in preclinical
models. When the most powerful of these antibodies was tested in
preclinical models for prevention or treatment of a potentially
lethal H5N1 infection, it was shown to prevent death and cure the
disease.
* In a preclinical study, Crucell's mAb CR6261 was compared with
the anti-influenza drug oseltamivir (Tamiflu) in terms of its
value for flu prevention and treatment. In December 2008, Crucell
announced that its monoclonal antibody strongly outperformed the
anti-influenza drug in these tests. The results were presented at
IBC's 19th Annual International Conference on Antibody
Engineering in San Diego, USA.
* The flu strains tested included the 'bird flu' strain H5N1, which
experts fear has the potential to cause a pandemic, and H1N1,
which is similar to a descendant of the flu virus that caused the
devastating pandemic in 1918. Importantly, the study showed that
CR6261 provides immediate protection against the influenza virus,
suggesting that it will be able to prevent disease spread. In
contrast, oseltamivir was less efficacious and in some cases not
effective at all. The characterization of the antibody was
described in the online journal PLoS ONE on December 16, 2008.
* In August 2009 Crucell received an award from the National
Institute of Allergy and Infectious Diseases (NIAID)/National
Institutes of Health (NIH) for the development of its monoclonal
antibodies for the treatment of seasonal and pandemic influenza.
The award provides funding of up to $40.7 million, with
additional options that may be triggered at the discretion of the
NIH worth a further $28.4 million, bringing the potential total
amount to $69.1 million.
* In September JNJ, through its subsidiary Ortho-McNeil-Janssen
Pharmaceuticals, Inc., and Crucell entered into a strategic
collaboration focusing on the discovery, development and
commercialization of monoclonal antibodies and vaccines for the
treatment and prevention of influenza and other infectious and
non-infectious diseases.
* The immediate focus of the collaboration will be the development
and commercialization of a universal monoclonal antibody product
(flu-mAb) for the treatment and prevention of influenza. The
focus of the long-term innovation collaboration will be on new
discovery programs leading to the development and
commercialization of a universal influenza vaccine as well as the
development of monoclonal antibodies and/or vaccines directed
against up to three other infectious and non-infectious disease
targets.
* Rabies Human Monoclonal Antibody Combination/CL184 (Phase II):
Crucell's monoclonal antibody combination against rabies is being
developed in close collaboration with Sanofi Pasteur using
Crucell's PER.C6® manufacturing technology. In 2008, Crucell
initiated two Phase II studies in the USA and the Philippines.
Promising Phase I data in 2007 showed no serious adverse effects
and demonstrated the expected rabies neutralizing activity upon
administration. The rabies human monoclonal antibody combination
was granted a Fast Track designation by the FDA Department of
Health and Human Services, ensuring priority handling of the
regulatory dossier. Under the terms of the collaboration
agreement with Sanofi Pasteur, Crucell will be responsible for
manufacturing the commercial product and has retained exclusive
distribution rights in Europe, co-exclusive distribution rights
in China and the rights to sell to supranational organizations
such as UNICEF, while Sanofi Pasteur will have exclusive
distribution rights for all other territories and co-exclusive
distribution rights in China. This antibody combination is
designed to be used in combination with a rabies vaccine for
post-exposure prophylaxis (PEP) against this fatal disease.
* Positive preliminary results of the Phase II US study were
presented to rabies experts at the 19th annual RITA meeting in
Atlanta on October 1, 2008. These results triggered another
milestone payment from Sanofi Pasteur at the end of September, as
part of the total eligible amount of €66.5 million.
* A second Phase II clinical study evaluating the monoclonal
antibody combination together with a rabies vaccine in healthy
children and adolescents was conducted in the Philippines from
May to October 2008. The completion of this study triggered
another milestone payment from Sanofi Pasteur, at the end of
October. In June 2009, Crucell announced the results of the
Philippines study, which showed that the antibody combination was
safe and well tolerated. Neutralizing activity levels in subjects
given the antibody product were similar to those in subjects
given human immunoglobulin (HRIG), the current standard for
inducing immediate, passive immunity. All study participants
reached adequate immunity levels. This study in children further
broadens the potential patient population for Crucell's rabies
monoclonal antibody combination. Detailed results of this study
have been presented at the XX Rabies in the Americas RITA
conference in Quebec, Canada on 20 October 2009.
* Plans to start an additional Phase II clinical study are
progressing well after recent approval received from the Drug
Controller General of India. This third Phase II study will be
carried out at Lotus Laboratories in Bangalore, India and is
planned to start within the next six months. The rationale for
this study is to collect safety and neutralizing activity data of
the CL184 antibody in combination with the vaccine in a simulated
rabies post-exposure prophylaxis setting to be used in Phase III.
* Tuberculosis Vaccine (AdVac®/PER.C6® Technology based; Phase
II): Development of the candidate vaccine AERAS-402/Crucell Ad35
is being carried out in collaboration with the Aeras Global TB
Vaccine Foundation. Data from all AERAS-402/Crucell Ad35 trials
support the immunogenicity and acceptable safety profile of the
TB candidate vaccine at all dose levels evaluated.
* Phase II: In October 2008 enrollment for the first Phase II study
of AERAS-402/Crucell Ad35 in Cape Town, South Africa was started.
The study is being conducted by the University of Cape Town Lung
Institute in conjunction with the South African Tuberculosis
Vaccine Initiative. The candidate vaccine is being tested in 116
adults who have had active TB. This study is currently enrolling.
No evidence of an unacceptable safety issue has been found in its
dose escalation design after enrollment and vaccination of 60
subjects to date.
* Phase I: The US Phase I trial in healthy adults not previously
immunized with Bacille Calmette-Guérin (BCG), the traditional TB
vaccine, has been completed and has demonstrated that
AERAS-402/Crucell Ad35 is safe in this population.
* Results of a second study in South Africa showed encouraging
results, notably CD8-cell immune responses that are much higher
than those seen in humans in any previous TB vaccine study.
* Two Phase I studies in healthy adults in St. Louis, USA, focusing
on the immunogenicity and safety of two AERAS-402/Crucell Ad35
boost doses administered at three to six month intervals after
BCG priming in healthy adults have been completed. Data from
these studies specifically indicate that two injections of
AERAS-402/Crucell Ad35 are immunogenic, with an acceptable safety
profile, when used with a BCG-prime in combination with the
AERAS-402/Crucell Ad35 candidate vaccine in BCG vaccinated
healthy adults, regardless of the boosting interval. This immune
response is greater than that detected in the absence of BCG
prime, supporting the possible utility of AERAS-402/Crucell Ad35
as a booster vaccine. BCG prime alone shows limited efficacy.
* In October 2008, a Phase I clinical trial of the jointly
developed TB vaccine was started in Kenya. The study is being
conducted by the KEMRI/Walter Reed Project-Kisumu at their
Kombewa Clinical Trials Center near Kisumu, in Western Kenya. Its
main objective will be to test the safety of the candidate
vaccine in BCG-vaccinated adults with or without latent
tuberculosis. This study has been completed, with ongoing
analysis and no safety issues identified.
* In April 2009, a Phase I clinical trial in infants of the jointly
developed TB candidate vaccine AERAS-402/Crucell Ad35 was started
in South Africa. This is the first clinical trial designed to
test this candidate vaccine in infants. The Phase I study of
AERAS-402/Crucell Ad35 is being conducted by the South African
Tuberculosis Vaccine Initiative (SATVI) in the Western Cape
region of South Africa. The main objective of the study is to
test the safety of the TB candidate vaccine in infants previously
vaccinated with BCG vaccine, which is currently the only vaccine,
licensed to help prevent TB. This study is fully enrolled and
dosing is ongoing. No safety issues have been identified.
* Malaria Vaccine (AdVac®/PER.C6® Technology based; Phase I):
Crucell and its collaborator, the US National Institute of
Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH), are conducting a Phase I trial in the
USA for a recombinant malaria vaccine, Ad35-CS, based on the
company's AdVac® technology and PER.C6® manufacturing platform.
The candidate vaccine is made by inserting the gene for the
circumsporozoite protein (CSP) from the Plasmodium falciparum
malaria parasite into adenoviral vectors, which act as a
'vehicle' for vaccination delivery. The study is being carried
out at two sites, Vanderbilt University in Nashville, Tennessee
and Stanford University in Palo Alto, California. All four
cohorts have been enrolled, and ongoing safety monitoring has
revealed no significant safety concerns to date. Boost
vaccinations for the fourth and final group of volunteers is
underway. Preliminary examination of the blinded data from the
first four cohorts indicates that the vaccine is immunogenic.
Detailed analysis of the data awaits completion of the fourth
cohort and unblinding of the data.
* In July 2009 Crucell announced a new collaboration with US-based
MVI and USAID MVDP to accelerate development of a promising new
type of malaria vaccine. Through funding from the USAID MVDP, the
partners will conduct studies to determine the effectiveness of
Crucell's novel prime-boost vaccine approach against the malaria
parasite P. falciparum. This approach uses Crucell's proprietary
recombinant adenoviruses (a type of virus associated with the
common cold and other mild respiratory infections), to deliver a
malaria antigen to the immune system. Using Crucell's AdVac®
technology with two different adenovirus vectors-Ad35 and Ad26-as
delivery mechanisms, this approach seeks to elicit a protective
immune response obtained from delivering the circumsporozoite
protein (CSP).
* Multivalent Filovirus (Ebola & Marburg) Vaccine (AdVac®/PER.C6®
Technology based; Phase I): In October 2008 Crucell announced
that it has secured a NIAID/NIH award to advance the development
of Ebola and Marburg vaccines, with the ultimate aim of
developing a multivalent filovirus vaccine. The award provides
funding of up to $30 million, with additional options, which may
be triggered at the discretion of the NIH, worth a further $40
million. The Phase I study of an adenovirus 5 (Ad5)-based Ebola
vaccine that Crucell is developing in partnership with the
Vaccine Research Center (VRC) of the NIAID/NIH, showed safety and
immunogenicity at the doses evaluated. Based on these results, a
second Phase I study of an Ebola and/or Marburg vaccine is
anticipated. This will use alternative multivalent adenovirus
vectors that are able to bypass pre-existing immunity against
Ad5.
* HIV Vaccine (AdVac®/PER.C6® Technology based; Phase I): The
Investigational New Drug Application (IND) for Phase I of the
trial with Harvard Medical School (supported by the NIH) was
approved by the FDA in January 2008. In April 2008, Crucell
announced the start of a Phase I clinical study of the novel
recombinant HIV vaccine, using adenovirus serotype 26 (rAd26) as
vector, that Crucell is jointly developing with the Beth Israel
Deaconess Medical Center. The rAd26 vector is specifically
designed to avoid the pre-existing immunity to the more commonly
used adenovirus serotype 5 (Ad5). The Phase I clinical study is
being conducted at the Brigham and Women's Hospital in Boston,
USA and is focused on assessing the safety and immunogenicity of
the vaccine. Enrollment is ongoing and involves 48 healthy
volunteers. Dose escalation has proceeded without difficulty and
the third cohort has been fully enrolled. Boost vaccinations are
ongoing. On 21 October 2009 preliminary results of the Phase I
study were presented at La Conférence AIDS Vaccine 2009 in Paris,
France. The presentation was given by Dr Dan H. Barouch, MD, PhD,
Associate Professor of Medicine, Division of Vaccine Research,
Department of Medicine at the Beth Israel Deaconess Medical
Center (BIDMC) in Boston, USA. The preliminary results of this
study show that this HIV candidate vaccine is safe and
immunogenic.
* Alternative Adenovirus Serotype Technologies: In November 2008,
the leading scientific journal Nature published a study that
demonstrated the value of Crucell's alternative adenovirus
serotype technologies. Using Crucell's AdVac® vaccine technology
and PER.C6® manufacturing technology, scientists engineered the
rare adenovirus serotypes Ad26 and Ad35 to express a protein of
SIV, the non-human primate equivalent of HIV. Rare serotype
adenoviral vectors-such as rAd26 and rAd35 vectors- have been
developed by Crucell to provide more potent prime-boost vaccine
regimens. The study, which investigated the immunogenicity and
protective efficacy of different vaccination regimes using rAd26,
rAd35 or rAd5 as a prime, followed by a boost with rAd5, showed
that in particular the rAd26/rAd5 combination elicits a strong
T-cell immune response and provides protection against the
HIV-like virus in non-human primate models. Crucell has several
vaccines in development using alternative rAd26 and rAd35
vectors, including vaccines against malaria and tuberculosis.
* Hepatitis C Antibody Combination (Preclinical): In August 2009
Crucell obtained an exclusive license from Stanford University
(Palo Alto, California) for the development of an antibody
combination against the hepatitis C virus. A large panel of fully
human monoclonal antibodies against the hepatitis C virus (HCV)
is being evaluated by Crucell in a proof of concept phase. The
monoclonal antibodies have been found to neutralize HCV across
all genotypes tested and each recognizes a different part of the
HCV surface protein.
* Blood Coagulation Factor VL/C (Research): Preclinical work on
this program continues but conclusive proof of concept is not
expected in the near future.
Building Development Capability:
To strengthen Crucell's capabilities to deliver on its pipeline, the
company hired 110 new employees since January 2009. With these new
employees Crucell strengthens its team with new leadership and
process experts. Many of these new colleagues will be working in
Switzerland, in the two buildings that have been reutilized to
establish new process development laboratories. Crucell will use
these laboratories to get FDA approval for Epaxal® in the USA.
Korean Production Facility:
In October 2008 Crucell announced that an agreement was reached to
relocate Crucell's Korean production facility from the Shingal site
in Yongin City, Korea to the Incheon Free Economic Zone, Korea.
Construction activities at the new site started in December 2008 and
are progressing well. First test runs are planned for the first half
of 2010. The new facility will enable the further growth and
efficient production of Quinvaxem® and Hepavax-Gene®. The investments
in the new facility are expected to total approximately €50 million,
with the majority of spending in 2009.
The Crucell Ambition:
In 2008, The Crucell Ambition program was rolled out throughout the
Company, focusing on four priority areas. These areas are:
Organization & People, Focus, Operational Excellence, and Deliver on
Promises.
The Operational Excellence 'Healthy Ambition' part of the program is
targeting savings of €30 million by the end of 2009 compared to the
2007 cost base (excluding R&D). In the first nine months of 2009, a
total of €15 million of net cost savings were achieved (Q1 2009 €6
million; Q2 2009 €4 million; Q3 2009 €5 million). Savings were
predominantly achieved through improved yields, marketing and sales
efficiency gain, and savings in overhead.
Manufacturing & Licensing Agreements:
* Crucell announced a non-exclusive PER.C6® research license
agreement with Australia-based Patrys Ltd. for the production of
several undisclosed antibodies. Financial details of the
agreement were not disclosed. [July 2009]
* Crucell today announces a non-exclusive PER.C6® research license
agreement with US-based TapImmune Inc. for use in its vaccine
development programs. Financial details of the agreement were not
disclosed. [September 2009]
* Crucell today announces an agreement with US-based Calmune
Corporation, including an exclusive license on an undisclosed
antibody based on Calmune's technology and a co-development for
the discovery of new antibodies against the same target.
Financial details of the agreement were not disclosed. [September
2009].
Patents:
In Q3 2009 Crucell was granted a total of 22 patents, including
patents for:
* Monoclonal antibodies against rabies, in the U.S. and Singapore
* AdVac® based malaria vaccines, in Australia
* Production of antibody fragments using PER.C6® expression
technology, in Australia
* Elements of STAR® technology, in India
* Improvements in PER.C6® expression technology, in New Zealand
* Purification of AdVac® vectors, in Europe and New Zealand
Financial Review Third Quarter 2009
Total Revenues and Other Operating Income
Total revenues and other operating income amounted to €94.3 million
for the third quarter of 2009, an increase of 15% compared to the
same quarter of 2008. The increase of 15% was mainly driven by strong
sales of paediatric and respiratory vaccines. Travel and endemic
vaccines also showed solid growth due to the growth of Epaxal®,
despite the impact of reduced travel from the economic crisis.
Product sales in the third quarter of 2009 increased 28% over the
same quarter in 2008 to €83.7 million and represent sales of
paediatric vaccines (46%), travel and endemic vaccines (14%),
respiratory vaccines (31%) and other products (9%).
License revenues were €3.8 million in the third quarter, a decrease
of €6.6 million compared to the third quarter of 2008 (which included
milestone payments of €6.0 million for the Phase II results of the
rabies monoclonal antibody combination and for Sanofi Pasteur's
seasonal influenza vaccine (FluCell).
Service fees for the quarter were €2.4 million, compared to €2.6
million last year. Service fees represent revenues for product
development activities performed under contracts with partners and
licensees.
Other operating income was €4.4 million for the quarter, compared to
€3.5 million in the third quarter of 2008.
Cost of Goods Sold
Cost of goods sold for the third quarter of 2009 amounted to €55.1
million, €53.1 million of which represents product costs and €2.0
million the cost of service and license activities.
In line with expectations, gross margins were 39% in the quarter,
compared to 50% in the same period in the prior year. The timing of
development milestone payments from partners significantly influence
margins and profitability in the period in which they are recognized.
The third quarter of 2008 included €6.0 million milestone payments.
The remaining drop in margins is due to unfavorable movement of the
US Dollar versus the Euro.
We expect continued pressure on margins in the last quarter of the
year as a result of exchange rates, which affects our reported
product sales and cost of goods sold.
Expenses
Total expenses consist of research and development (R&D) expenses,
marketing and sales (M&S) and general and administrative (G&A)
expenses. Total expenses for the third quarter were €23.7 million,
representing a €9.2 million decrease compared to the same period in
2008. The decrease was mainly due to the reversal of impairment of
two buildings in Switzerland, which were selected as development
production sites for Epaxal® (hepatitis A) and tuberculosis vaccines.
SG&A (M&S+G&A) expenses for the quarter were €15.2 million compared
to €15.2 million in the third quarter of 2008.
Operating profit was €15.5 million in the third quarter of 2009
compared to €9.6 million operating profit in the same quarter of
2008. Operating profit was positively affected by a €8.1 million
impairment reversal of two state-of-the-art buildings in Bern
(Switzerland). The buildings were impaired in the fourth quarter of
2006 as there was no direct use for the buildings. In 2009
alternative use of the buildings arose as additional development
facilities were required for two strategic development programs and
the buildings proved to be suitable. The buildings are currently
being adapted to the specific needs of the development programs,
which will avoid major spending in the construction of new
development facilities. The initial impairment that was already
partially reversed in the first quarter of 2008 for an amount of €5.2
million has now fully been reversed.
Financial Expenses and Taxes
Net financial expenses in the third quarter were €0.9 million. This
was mainly the result of interest expenses and currency losses on the
US Dollar.
The company recorded a €4.6 million income tax charge in the third
quarter of 2009, mainly due in Switzerland, Spain and Korea. The
consolidated effective income tax rate was 32% in the third quarter
of 2009. The consolidated profit before tax was reduced by a
significant operating loss in the Netherlands as a result of R&D
expenses for which no tax benefit is recognized. This led to a
relatively high effective tax rate. A further tax charge was due to
the reversal of impairment.
Net Result
Net income of €10.0 million was reported in the third quarter of 2009
versus a net income of €12.8 million in the same quarter of 2008. Net
result per share in the third quarter of 2009 is €0.15, compared to a
net result per share of €0.19 in the third quarter of 2008.
Balance Sheet
Tangible fixed assets amounted to €178.3 million on September 30,
2009. Intangible assets amounted to €73.8 million. This includes
acquired in-process research and development, developed technology,
patents and trademarks, and the value of customer and supplier
relationships.
Investments in associates and joint ventures amounted to €9.3 million
and mainly represent investments in AdImmune and the PERCIVIA PER.C6®
Development Center. Crucell's investment in Galapagos NV is
classified under available-for-sale investments.
As part of the strategic collaboration with JNJ, the company sold
14.6 million newly issued ordinary shares to JNJ for an aggregate
purchase price of € 301.8 million, which included a premium of €69.5
million classified as deferred income, which will be amortized over
the development period of flu-mAbs.
Total equity on September 30, 2009 amounted to €717.5 million. A
total of 81.3 million ordinary shares were issued and outstanding on
September 30, 2009.
Cash Flow and Cash Position
Cash and cash equivalents increased by €190.0 million in the third
quarter to €311.6 million.
Net cash from operating activities in the third quarter improved
significantly to €72.1 million, up from minus €9.9 million in the
same quarter of 2008. This was driven by the upfront payments of JNJ
for participation in Crucell's development programs.
Cash used in investing activities amounted to €118.0 million, which
includes a long term deposit of €100.0 million with a maturity of
over 3 months, to take advantage of higher yields on longer term
deposits.
Net cash from financing activities in the third quarter was €235.0
million, compared to €11.3 million in the same quarter of 2008. This
increase reflects the cash proceeds from the issuance of shares to
JNJ.
Outlook 2009 reiterated [2]
* Crucell expects its combined full-year 2009 total revenues and
other operating income to grow 20% in constant currencies.
* Operating profit for 2009 is expected to improve significantly
compared to 2008.
* Maintain current strong cash position.
* Crucell does not expect its results to be materially affected by
the global recession.
Forward-looking statements
This press release contains forward-looking statements that involve
inherent risks and uncertainties. We have identified certain
important factors that may cause actual results to differ materially
from those contained in such forward-looking statements. For
information relating to these factors please refer to our Form 20-F,
as filed with the US Securities and Exchange Commission on April 22,
2009, in the section entitled 'Risk Factors'. The Company prepares
its financial statements under International Financial Reporting
Standards (IFRS).
Conference Call and Webcast
At 14:00 Central European Time (CET), Crucell's management will
conduct a conference call, which will also be webcast. To participate
in the conference call, please call one of the following telephone
numbers 15 minutes prior to the event:
+44 203 003 2666 for the UK;
+1 646 843 4608 for the US; and
+3120 794 8426 for the Netherlands
Following a presentation of the results, the lines will be opened for
a question and answer session.
The live audio webcast can be accessed via the homepage of Crucell's
website at www.crucell.com and will be archived and available for
replay following the event.
About Crucell
Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss 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 Argentina, China, Italy, Korea, Spain, Sweden,
Switzerland, UK and the USA. The Company employs over 1200 people.
For more information, please visit www.crucell.com.
Financial Calendar
9 February 2010 Q4 Results 2009
11 May 2010 Q1 Results 2010
4 June 2010 Annual General Meeting of Shareholders
17 August 2010 Q2 Results 2010
9 November 2010 Q3 Results 2010
15 February 2011 Q4 Results 2010
For further information please contact:
Crucell N.V.
Oya Yavuz
Vice President
Corporate Communications & Investor Relations
Tel. +31 (0)71 519 7064
ir@crucell.com
www.crucell.com
____________________
[1] The discovery and characterization of this unique class of human
influenza antibodies was reported in the online journal PloS ONE on
16 December 2008. An imaging study published in the prestigious
journal Science on 26 February 2009 described the mechanism
explaining their broad-spectrum protection by showing that the
antibody binds to a part of the influenza virus that is conserved
(invariable) from one viral strain to the next. Antibodies produced
by the body in response to influenza infection or vaccination bind to
a part of the virus that tends to mutate.
[2] Constant currencies = EUR/USD rate of 1.35
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