Crucell Announces Profits for Full Year 2008
Crucell Announces Profits for Full Year 2008
-- Net profit in 2008 was EUR 14.6 million compared to a net loss of
EUR 42.9 million in 2007.
-- Total revenue and other operating income increased by 33% to
EUR 283.3 million compared to EUR 213.1 million in 2007.
-- Positive cash flow of EUR 7.7 million increased the year-end cash
position to EUR 171 million.
-- Gross margin for the year improved to 45% (from 34% last year).
Dutch biopharmaceutical company Crucell N.V. (Euronext: CRXL) (NASDAQ: CRXL) (SWISS: CRX) today announced its financial results for the fourth quarter and full year 2008, based on International Financial Reporting Standards (IFRS). These financial results are unaudited.
Highlights:
* Crucell achieved profitability for the fourth quarter as well as
for the full year; net profit in 2008 was EUR 14.6 million, compared
to a net loss of EUR 42.9 million in 2007. This amounted to EUR 0.22
net profit per share, compared to a net loss per share of EUR 0.66
in 2007.
* On January 7th, 2009 Crucell announced that it was in friendly
discussions with Wyeth regarding a potential combination of the
two companies. On January 26th, 2009 Crucell announced that Wyeth
withdrew from these discussions.
* In 2008 Crucell more than doubled the production of its
pentavalent children's vaccine Quinvaxem®. In 2008 supranational
organizations awarded Crucell additional contracts for supplies
of Quinvaxem® and Hepavax-Gene® for the period 2008 - 2009,
bringing the total for the period 2007 - 2009 to $0.5 billion.
* Crucell announced that Chinese authorities have approved
Hepavax-Gene® for use in the private vaccine market in China.
* Crucell announced that its monoclonal antibody (mAb) directed
against a broad range of influenza virus strains has strongly
outperformed oseltamivir, an anti-influenza drug, in preclinical
tests.
* In 2008 Crucell's human monoclonal antibody combination against
rabies and novel vaccine against tuberculosis both entered into
Phase II clinical testing.
* In 2008 DSM and Crucell announced a series of important advances
in antibody production using PER.C6® technology platform. For
example, a PER.C6® human cell line and proprietary XD(TM)
technology were employed to achieve a record yield of over 27
grams per liter of IgG antibodies.
* Crucell announced that its PER.C6® technology licensee Ark
Therapeutics has entered a Phase III study with its product
Trinam. Ark Therapeutics is the first licensee to enter into a
Phase III study with a product produced on Crucell's PER.C6®
human cell line.
* Crucell signed new license agreements with several parties,
including CSL Ltd. and GlaxoSmithKline, as well as a second
exclusive license agreement with Talecris Biotherapeutics.
Financial Highlights Fourth Quarter 2008:
* Combined total revenue and other operating income for the fourth
quarter were EUR 93.7 million, compared to EUR 75.9 in the same quarter
of 2007. The increase of 23% (22% in constant currencies[1]) was
driven by strong sales of paediatric vaccines, travel and endemic
vaccines as well as higher license revenues.
* Milestone payments for Crucell's rabies monoclonal antibody
combination accounted for the increase of license revenues
* Gross margins of 50%, compared to 34% in the fourth quarter of
2007. Gross margins were positively influenced by a large
increase in product sales, license revenues and a positive
currency impact as well as significant improvements in production
performance.
* Net profit in the fourth quarter of 2008 was EUR 19.2 million versus
a net loss of EUR 4.0 million in the same quarter of 2007.
* Net cash from operating activities in the fourth quarter of 2008
was EUR 61.5 million, compared to EUR 51.5 million in the same quarter
of 2007.
* Overall, the net increase in cash and cash equivalents in the
fourth quarter amounted to EUR 67.0 million, versus EUR 56.3 million in
the fourth quarter of 2007.
* In anticipation of the expected further growth of Quinvaxem® in
2009, Crucell continued to build stock of Quinvaxem® in the
fourth quarter of 2008.
Financial Highlights Full Year 2008:
* Combined total revenue and other operating income for the full
year 2008 of EUR 283.3 million, compared to EUR 213.1 in 2007. The
increase of 33% (38% in constant currencies[1]) was largely
driven by strong sales of paediatric vaccines, travel and endemic
vaccines as well as higher license revenues.
* Crucell achieved profitability for the full year 2008, reporting
a net profit of EUR 14.6 million, compared to a net loss of EUR 42.9
million reported in 2007. This amounted to EUR 0.22 net profit per
share in 2008, compared to a net loss per share of EUR 0.66 in 2007.
* Operating cash flow of minus EUR 0.3 million for the year, compared
to EUR 22.2 million in 2007, due to inventory build-up of Quinvaxem®
for sales in 2009.
* Cash and cash equivalents increased by EUR 7.7 million during the
year to EUR 171.0 million at year-end 2008.
Key Figures 2008:
(EUR million, except net result per share)
Fourth
Fourth quarter Full Year 2008
-------------- --------------
2008 2007 2008 2007
Change Change
Total revenues
93.7 75.9 23% and other 283.3 213.1 33%
operating income
19.2 (4.0) Net result 14.6 (42.9)
Net result per
0.29 (0.06) share (basic) 0.22 (0.66)
Cash & cash
equiv.:
- Dec 31, 2008 171.0
- Dec 31, 2007 163.2
Crucell's Chief Executive Officer Ronald Brus said:
"I am very proud that for the first time in the history of our company, we achieved profitability for the year. Together with our strong revenue growth and cash position, we were able to end the year on a historic high.
Our core business is stronger than ever and, with a clear strategy for sustainable growth and more focused research and development activities, we continue to increase the number of people we can protect from infectious diseases.
For 2009, we expect another good year for Crucell. Our sense of shared purpose is stronger than ever, and we look forward to ongoing growth of our product sales as well as further progress of our pipeline programs."
Product and Business Update
Product Update:
Product sales in the fourth quarter of 2008 amounted to EUR 76.5 million and represent sales of paediatric vaccines (51%), travel and endemic vaccines (23%), respiratory vaccines (17%) and other products (9%).
For the full year 2008, product sales were EUR 226.1 million, representing sales of paediatric vaccines (49%), travel and endemic vaccines (25%), respiratory vaccines (14%) and other products (12%).
Paediatric
Sales of our paediatric vaccines showed strong growth in the fourth quarter and the year 2008, mainly 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.
The product is currently registered in selected countries
worldwide. Sales in South America are progressing well and a
European launch is planned this year.
* MoRu-Viraten®: Vaccine for protection against measles and rubella
(for all age groups).
Travel and Endemic
Our travel and endemic portfolio showed solid growth in 2008. We continue to see significant untapped demand and potential for geographical expansion of our travel portfolio.
* Epaxal®: The only aluminum-free vaccine against hepatitis A.
* Vivotif®: The only oral vaccine against typhoid fever.
* Dukoral®: The only oral vaccine against cholera and diarrhea
caused by ETEC (enterotoxigenic E. coli).
Respiratory
In the fourth quarter of 2008, sales of our flu vaccine Inflexal® V were slightly down, compared to the same quarter of 2007 due to phasing into the third quarter of 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.
Pipeline Update:
* Flavimun® - Live Attenuated Yellow Fever Vaccine: Registration
submission of the Yellow Fever vaccine in Switzerland and Germany
is expected in the first quarter 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 U.S. 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 U.S. The trials focus on the safety profile and
immunogenicity of the cell-based vaccine.
* 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 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 EUR 66.5 million.
* A second phase II clinical study evaluating the monoclonal
antibody combination in combination with a 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 another
major 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 focuses 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.
* 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 U.S. 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, but formal analysis awaits unblinding of the
data. Enrollment for the fourth and final group of volunteers is
ongoing. Preliminary results of the first three cohorts are
expected before the end of the first quarter of 2009. Further
updates on this program will be communicated in our first quarter
2009 results.
* 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, being
developed 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 by-pass
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 currently enrolling subjects.
* 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.
* 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 have started and are well on track. The new facility will
enable the further growth and efficient production of Quinvaxem®
and Hepavax-Gene®. The investments in the new facility are
expected to total approximately EUR 50 million, with the majority of
spend in 2009.
Etna Biotech Srl:
* Crucell announced in November 2008 the sale of its fully-owned
subsidiary Etna Biotech Srl (Catania, Italy) to Zydus Cadila
(Ahmedabad, India). The sale results in net proceeds for Crucell
of several hundred thousand Euros. This transaction is in line
with Crucell's increased focus on the strengths of its core
business.
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 are:
1. ORGANIZATION & PEOPLE. Development of our organization and our
people is the foundation for achieving our ambition as a company.
Multiple measures are being implemented to achieve this.
2. FOCUS. Crucell is clearly focused on its mission to protect lives
from infectious diseases by bringing innovation to global health.
We are building on our strengths by prioritizing those programs
that are in line with this ambition and that contribute to our
strategic and financial objectives.
3. OPERATIONAL EXCELLENCE. Crucell launched its 'Healthy Ambition'
operational excellence program at the start of 2008 and is now
implementing the validated plans drawn up in the first half of
the year. By streamlining and optimizing our business processes,
the program is expected to generate cost savings of EUR 30 million
by the end of 2009.
4. DELIVER ON PROMISES. Crucell has set its sights high and is
firmly committed to delivering on its ambitious promises.
Evidence-based target setting and a company-wide emphasis on
organization and people focus and operational excellence will
enable us to do so.
Crucell's operational excellence program 'Healthy Ambition' was rolled out in 2008. The program is targeting savings of EUR 30 million by the end of 2009; initial net cost savings of EUR 5 million were achieved in the second half of 2008. The Operational Excellence program has positively contributed to the results through improved yields in our Korean production facility, savings in overhead and several other 'quick wins' delivered in 2008.
Manufacturing & Licensing Agreements:
* Crucell announced a non-exclusive PER.C6® research license
agreement with Australian-based Arana Therapeutics, Ltd. for the
production of monoclonal antibodies. Financial details of the
agreement were not disclosed. [October 2008]
* Crucell announced a non-exclusive PER.C6® research license
agreement with Australian-based Abraxis Bioscience, Inc., for the
production of proteins. Financial details of the agreement were
not disclosed. [October 2008]
* Crucell today announces a non-exclusive PER.C6® research license
agreement with Canada-based Cangene Corporation for the
development of several undisclosed antibodies. Financial details
of the agreement were not disclosed. [October 2008]
* Crucell announced a non-exclusive manufacturing, sales and
distribution agreement with Berlin-based Biochrom AG related to
the PERMEXCIS(TM) cell culture medium developed by Crucell for
PER.C6® cells. Biochrom will manufacture the medium, and in
addition will market and sell it in the European Union,
Switzerland, Turkey, Russia and Israel. Financial details of the
agreement were not disclosed. [November 2008]
* DSM Biologics and Crucell announced that Hungary-based Gedeon
Richter Plc. signed a commercial license agreement allowing
Gedeon Richter to develop and produce certain biopharmaceuticals
on the PER.C6® platform. Other terms of the agreement were not
disclosed. [November 2008]
* Crucell today announces a non-exclusive PER.C6® research license
agreement with Netherlands-based Synthon B.V. for the production
of biosimilar proteins. Financial details of the agreement were
not disclosed. [November 2008]
* Crucell today announces a non-exclusive PER.C6® research license
agreement with Norway-based Affitech AS for the development of
several undisclosed antibodies. Financial details of the
agreement were not disclosed. [November 2008]
* Crucell announced a second exclusive commercial license agreement
with North Carolina-based Talecris Biotherapeutics for an
undisclosed and specific protein and the exclusive rights to
produce that protein using a PER.C6® cell line.
Crucell will receive an upfront payment of $1.5 million following
the execution of the agreement and will be eligible for milestone
payments of approximately $20 million. Further financial details
of the agreement were not disclosed. [December 2008]
* DSM Biologics and Crucell announced that Australia-based CSL Ltd.
signed a license agreement allowing CSL to develop protein
therapeutics for multiple undisclosed disease targets on the
PER.C6® platform. Under the terms of the agreement, CSL is
responsible for the development of protein and antibody products
resulting from this alliance. Financial terms of the agreement
were not disclosed. [December 2008]
* DSM Biologics and Crucell announced that GlaxoSmithKline (GSK)
signed a research license agreement allowing GSK to research a
recombinant protein on the PER.C6® platform. Financial terms of
the agreement were not disclosed. [December 2008]
* Crucell today announces a non-exclusive PER.C6® commercial
license agreement with Australian-based Elm Biotech Pty Ltd,
managed by pharmaBank Pty Ltd, for the production of an
adenovirus-vectored Gene Therapy product. Financial details of
the agreement were not disclosed. [December 2008]
* Crucell today announces two non-exclusive PER.C6® commercial
license agreements with Netherlands-based ProFibrix B.V. for the
development of recombinant fibrinogen and a second undisclosed
recombinant protein. Financial details of the agreement were not
disclosed. [December 2008]
Patents:
In Q4 2008 Crucell was granted a total of 51 patents, including patents for:
* Different aspects of improved adenoviral AdVac® vectors and
AdVac® technology, in New Zealand, Eurasia, and the U.S.
* Rabies virus-neutralizing antibodies, in Europe
* PER.C6® protein expression technology, in Japan and the U.S.
* Improved materials for use in MAbstract® technology, in Canada
* Improvements in PER.C6® expression technology, in Europe
* Virus purification technology, in Europe
* Antiviral compound screening using PER.C6® technology, in Europe
Post Balance Sheet Events:
* 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]
* On January 7th, 2009 Crucell announced that it was in friendly
discussions with Wyeth regarding a potential combination of the
two companies. On January 26th, 2009 Crucell announced that Wyeth
withdrew from these discussions.
Financial Review
Total Revenue and Other Operating Income
Total revenue and other operating income was EUR 93.7 million for the fourth quarter of 2008, an increase of 23% compared to the same quarter of 2007 (22% in constant currencies[2]). The increase was driven by continued strong sales of paediatric, travel and endemic vaccines, as well as higher license revenues.
For the full year ending December 31, 2008, total revenue and other operating income was EUR 283.3 million. In constant currencies this would have been EUR 293.0 million.
Increase of license revenues was mainly driven by milestone payments for Crucell's rabies monoclonal antibody combination.
Product sales for the fourth quarter amounted to EUR 76.6 million and represent sales of paediatric vaccines (51%), travel and endemic vaccines (23%), respiratory vaccines (17%) and other products (9%).
License revenues were EUR 9.1 million in the fourth quarter, an increase of EUR 2.9 million compared to the same quarter of 2007. 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 EUR 4.0 million, compared to EUR 5.0 million last year. Service fees represent revenue for product development activities performed under contracts with partners and licensees. Other operating income was EUR 4.1 million for the quarter, compared to EUR 1.3 million in the fourth quarter of 2007.
Cost of Goods Sold
Cost of goods sold for the fourth quarter of 2008 amounted to EUR 44.8 million, EUR 42.6 million of which represents product costs and EUR 2.2 million the cost of service and license activities. Gross margins of 50%, compared to 34% in the fourth quarter of 2007. Gross margins in the fourth quarter of 2008 were positively influenced by an increase in product sales, license revenues and a positive currency impact as well as significant improvements in production performance.
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 fourth quarter were EUR 36.6 million, representing an EUR 1.7 million increase over the same period in 2007 (EUR 34.9 million).
R&D expenses for the fourth quarter amounted to EUR 19.1 million, which represents a EUR 0.8 million increase versus the fourth quarter of 2007.
SG&A expenses for the quarter were EUR 17.2 million, which represents a EUR 0.8 million increase versus the fourth quarter of 2007.
Net financial income and expenses in the fourth quarter of minus EUR 2.0 million were the result of foreign exchange losses mainly caused by fluctuations in the EUR/USD exchange rate.
The company recorded a EUR 8.8 million income tax gain in the fourth quarter as a result of tax benefits in Korea and previously unrecognized carry forward losses in Switzerland.
Net Result
Net profit of EUR 19.2 million was reported in the fourth quarter of 2008, compared to a net loss of EUR 4.0 million in the same period of 2007. This amounted to EUR 0.29 net result per share, compared to a net loss per share of EUR 0.06 in the fourth quarter of 2007. The company reported a net profit of EUR 14.6 million for the full year 2008 compared to a net loss of EUR 42.9 million in the same period of 2007. This amounted to EUR 0.22 net result per share, compared to a net loss per share of EUR 0.66 for the full year of 2007.
Balance Sheet
Tangible fixed assets amounted to EUR 151.2 million on December 31, 2008. Intangible assets, representing assets through acquisitions, amounted to EUR 79.0 million. This figure includes acquired in-process research and development, developed technology, patents and trademarks, and the value of customer and supplier relationships.
Investments in associates and joint ventures amounted to EUR 9.2 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, 2008 amounted to EUR 453.5 million. A total of 65.8 million ordinary shares were issued and outstanding on December 31, 2008.
Investment in working capital increased significantly, mainly due to build-up of paediatric vaccine inventory, in anticipation of strong 2009 sales.
Cash Flow and Cash Position
Cash and cash equivalents increased by EUR 67.0 million in the fourth quarter to EUR 171.0 million. Increase of cash flow and working capital in the fourth quarter was due to strong product sales and license revenues.
Net cash from operating activities in the fourth quarter of 2008 was EUR 61.5 million. Overall investments in net working capital increased mainly due to inventory build-up of Quinvaxem® in anticipation of the significant growth of Quinvaxem® expected in 2009. Net cash used in investing activities in the fourth quarter amounted to EUR 4.5 million. Net cash from financing activities in the fourth quarter amounted to EUR 9.4 million.
Outlook 2009[3]
* Crucell expects its combined full-year 2009 total revenue and
other operating income to grow by 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 EUR 50
million, with the majority of spend in 2009.
* Crucell does not expect its businesses 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. is currently finalizing the financial statements for the year ended December 31, 2008. We expect to be able to file our 2008 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 2008 before the end of April 2009. The consolidated balance sheet of Crucell N.V. as of December 31, 2008, the related consolidated statements of operations and consolidated statements of cash flows for the year ended December 31, 2008, 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 U.S. Securities and Exchange Commission on May 7, 2008, 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: CRXL) (NASDAQ: CRXL) (SWISS: CRX) is a global biopharmaceutical company focused on research development, production and marketing of vaccines, proteins and antibodies that prevent and/or treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oralanti-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
6 May 2009 Q1 Results 2009
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
Director Corporate Communications & Investor Relations
Tel. +31-(0)71-519 7064
ir@crucell.com
www.crucell.com
[1] Constant currencies = EUR/USD rate of 1.38
[2] Constant currencies = EUR/USD rate of 1.38
[3] Guidance currency = EUR/USD rate of 1.35
This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
