UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 6-K
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REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
The Securities Exchange Act of 1934
November 14, 2007
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CRUCELL NV
(Exact name of registrant as specified in its charter)
P.O. BOX 2048 ARCHIMEDESWEG 4 2333 CN LEIDEN THE NETHERLANDS
(Address of principal executive offices)
000-30962
(Commission File Number)
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Indicate by check mark whether the registrant files or will file annual reports
under cover of Form 20-F or Form 40-F:
Form 20-F [X] Form 40-F [ ]
Indicate by check mark whether the registrant by furnishing the information
contained in this form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes [ ] No [X]
CRUCELL ANNOUNCES THIRD QUARTER 2007 RESULTS
Total revenue and other operating income increased by
115% to (euro)62.6 million in the third quarter
compared to the same quarter last year, largely
driven by increased sales of Quinvaxem(TM) and
Inflexal(R) V. Gross margin in the third quarter
improved from 19.5% last year to 35.9%.
FULL YEAR GUIDANCE REITERATED; total revenues and
other operating income of (euro)220-225 million;
cash break-even on 'net cash from operating
activities'.
LEIDEN, THE NETHERLANDS (NOVEMBER 13, 2007) - Dutch biotechnology company
Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) today announced its
financial results for the third quarter and nine months ended September 30,
2007, based on International Financial Reporting Standards (IFRS). These
financial results are unaudited.
BUSINESS HIGHLIGHTS:
o Sanofi pasteur announces the start of Phase II with seasonal flu vaccine.
This vaccine is being developed using Crucell's PER.C6(R) cell line
technology.
o Crucell presents First-in-Man Phase I results of the rabies monoclonal
antibody cocktail (containing two antibodies), showing safety and ability
to protect. The cocktail, using Crucell's MAbstract(R) and PER.C6(R)
technologies, is well tolerated, provides the expected neutralizing
activity and can be administered in combination with a rabies vaccine.
o Crucell announces that its rabies monoclonal antibody cocktail has been
granted a Fast Track designation by the Food and Drug Administration's
(FDA) Department of Health and Human Services.
o Merck announces the discontinuation of its HIV vaccine candidate, which was
in phase I and II studies. The discontinuation of the studies was not
related to the use of Crucell's PER.C6(R) technology.
o Crucell announces that Merck & Co., Inc. has exercised an option for the
access to Crucell's AdVac(R) vaccine technology and for the exclusive use
of Crucell's PER.C6(R) technology in two infectious disease areas.
o Crucell announces that it has entered into a co-exclusive PER.C6(R) and
AdVac(R) technology license agreement with Wyeth Pharmaceuticals, a
division of Wyeth.
o Crucell discovers human monoclonal antibodies for the prevention and
treatment of the avian flu virus. The antibody provides immediate
protection and neutralizes the broadest range of H5N1 strains in pre-
clinical models.
o Crucell announces a non-exclusive STAR(R) research license agreement with
Invitrogen Corporation's PD-Direct(TM) Bioprocess Services.
FINANCIAL HIGHLIGHTS THIRD QUARTER 2007:
o Combined total revenue and other operating income of (euro)62.6 million
showed an increase of 115% over the same quarter last year ((euro)29.1
million).
o The increase of total revenue is primarily attributable to the successful
roll-out of Quinvaxem(TM), overall increase of vaccine sales and increased
revenues related to acquisitions made in the second half of 2006.
o Third quarter results were boosted by the phasing of vaccine sales compared
to the same quarter last year, when a substantial proportion of influenza
vaccine shipments were postponed to the fourth quarter.
o Sales of Quinvaxem(TM) are expected to accelerate further in the fourth
quarter of this year as momentum for the product continues to increase.
o Full year expectations for total revenue and other operating income remain
in the (euro)220 to (euro)225 million range.
o Gross margin increased to 35.9%, which represents a significant increase
over the third quarter of last year (19.5%) due to increased sales and
lower acquisition related costs in cost of sales.
o Net loss for the third quarter was (euro)4.5 million versus a net loss of
(euro)21.7 million the same quarter last year.
o Net cash used in operating activities in the third quarter was (euro)5.5
million compared to (euro)27.0 million in the same quarter last year.
o Operating activities before changes in net working capital resulted in a
positive (euro)7.2 million cash flow, which was offset by a (euro)12.7
million increase in working capital. This was largely driven by a sharp
increase in accounts receivable due to Inflexal(R) V shipments.
o Due to the seasonal pattern of cash inflow, the company reiterates its
outlook for the full year, to achieve cash break-even on 'net cash from
operating activities'.
KEY FIGURES THIRD QUARTER 2007 ((euro) million, except net loss per share)
Third quarter Nine months ended Sept. 30
2007 2006 Change 2007 2006 Change
Total revenues and other
62.6 29.1 115% operating income 137.2 64.5 113%
(4.5) (21.7) (79)% Net loss (41.2) (62.7) (34)%
Net loss per share
(0.07) (0.36) (basic and diluted) (0.63) (1.12)
Cash & cash equiv.:
- Sept. 30,2007 107.0
- Dec 31, 2006 157.8
Crucell's Chief Executive Officer Ronald Brus said:
"In the third quarter we achieved solid progress in two of our antibody
programs. We discovered a set of human monoclonal antibodies providing immediate
protection against pandemic flu and we successfully completed a Phase I study
for our rabies human monoclonal antibody study, showing safety and tolerability.
For this program we have now been granted a Fast Track designation by the FDA.
These programs reflect Crucell's underlying strength in R&D.
"Our third quarter results reflect the momentum we see in the underlying
business, where we saw strong sales of Quinvaxem(TM), our Flu product
Inflexal(R) V and travel vaccines.
"Based on these results, due to the seasonality of our business and our
expectations for the fourth quarter, we are reiterating our guidance for
combined total revenue and other operating income of (euro)220 to (euro)225
million for 2007. As indicated in the past, we also expect to achieve
operational cash break-even for the full year based on higher expected sales and
improvements in net working capital at year-end."
BUSINESS UPDATE
CLINICAL PROGRAM UPDATE - VACCINES
o INFLUENZA - SEASONAL FLU VACCINE (FluCell collaboration with sanofi
pasteur): Based on Phase I clinical study results of the PER.C6(R)-based
seasonal influenza vaccine, Crucell's partner sanofi pasteur - the vaccines
division of the sanofi-aventis Group - has announced that it has initiated
Phase II testing of its cell culture-based seasonal influenza vaccine in
the U.S. This project is part of a contract awarded in 2005 by the U.S.
Department of Health and Human Services (HHS) aimed at accelerating the
development of a new cell culture-based influenza vaccine. Phase II trials
involving healthy adult volunteers in the U.S. will focus further on the
safety profile and immunogenicity of the cell-based vaccine. This vaccine
was developed using Crucell's PER.C6(R) technology, which offers sanofi
pasteur a promising and reliable production method for seasonal and
pandemic influenza vaccines in addition to traditional, proven egg-based
production. The production scale potential of the PER.C6(R) cell line has
been demonstrated in a bioreactor of 20,000 liters, suggesting robustness
of PER.C6(R) technology.
o INFLUENZA - PANDEMIC VIROSOMAL FLU VACCINE H9N2 (based on proprietary
Inflexal(R) V technology): Phase I and II studies have been completed and
the results are currently being analyzed. No serious adverse side effects
were reported to date. Findings are expected to be released first half of
2008.
o HEPATITIS A: Pediatric Epaxal(R) was licensed earlier this year in
Switzerland. The product is currently under registration in selected
endemic countries.
o WHOLE-KILLED VIRUS WEST NILE VACCINE: The Phase I trial was completed,
early this year, demonstrating safety and tolerability. Phase II studies
for the vaccine are currently being planned. In addition Crucell has
developed human monoclonal antibodies against West Nile for therapeutic use
and, as communicated previously, options are currently being explored. A
decision will be communicated in our fourth quarter results press release
in February 2008.
o ADVAC(R)/PER.C6(R) TECHNOLOGY-BASED EBOLA VACCINE : Phase I study for the
Ebola vaccine, which Crucell is currently developing in partnership with
the Vaccine Research Center (VRC) of the National Institute of Allergy and
Infectious Diseases (NIAID). Efficacy studies in non-human primates were
successful. The clinical findings are expected to be reported in the first
quarter of 2008.
o LIVE ATTENUATED YELLOW FEVER VACCINE FLAVIMUN(R): Registration submission
in Switzerland is expected in 2008.
o ADVAC(R)/PER.C6(R) TECHNOLOGY-BASED TUBERCULOSIS VACCINE: The development
of this vaccine is being carried out in collaboration with the Aeras Global
TB Vaccine Foundation. US Phase I trial (in BCG naive individuals) has been
completed. All data has been collected, including the 6 months follow-up
data. This is being analyzed and we expect initial findings to be made
public in the first quarter of 2008. No serious adverse side-effects were
reported to date. In May a second clinical trial was initiated in South
Africa. This Phase I trial is a placebo controlled study in adults who were
vaccinated at birth with the BCG vaccine, and it continues to progress
well.
o ADVAC(R)/PER.C6(R) TECHNOLOGY-BASED MALARIA VACCINE: Crucell and its
partner, the National Institute of Allergy and Infectious Diseases (NIAID),
part of the National Institutes of Health (NIH), have added an additional
clinical site in the US to speed up recruitment for their Phase I trial.
Since opening the additional site, the pace of recruitment has increased
allowing so far enrolment of 18 and 15 volunteers in the first and second
cohort, respectively. Initial findings of Phase I results are expected to
be available in 2008. No serious adverse side-effects have been reported to
date.
o MERCK AD5 HIV VACCINE: DISCONTINUED
Merck's HIV vaccine candidate was in phase I and II studies when
discontinuation of the trials was announced on 21 September 2007. The
discontinuation of the studies was not related to the use of Crucell's
PER.C6(R) technology. Merck and the HVTN reported initial analysis of
Merck's HIV vaccine STEP studies and the results suggest that pre-existing
immunity to adenovirus serotype 5 (Ad5) may be an issue. Ad5, a common cold
virus, is the most commonly used recombinant vaccine vector. To
specifically address pre-existing immunity to Ad5 in humans, Crucell
designed AdVac(R) technology, which is based on adenovirus vectors that do
not regularly occur in the human population. AdVac(R) technology is widely
used by Crucell and its partners, and all vaccine candidates based on
AdVac(R) technology are produced using Crucell's PER.C6(R) production
technology.
o ADVAC(R)/PER.C6(R) TECHNOLOGY-BASED HIV VACCINE: Investigational New Drug
Application (IND) for Phase I of the trial with Harvard Medical School
(supported by the NIH) has been submitted to the FDA.
CLINICAL PROGRAM UPDATE - PROTEINS
o RABIES HUMAN MONOCLONAL ANTIBODY MIX: Phase I of the US study has been
completed. No serious adverse effects were reported and the treatment was
well tolerated. Data indicates that the cocktail is well tolerated,
provides the expected neutralizing activity and that it can be administered
in combination with rabies vaccine. Phase I trial in India, which started
in April 2007, has also been completed. Data analysis is completed and will
be presented on November 30, 2007 at the Joint International Tropical
Medicine Meeting 2007 in Bangkok, Thailand.
Crucell has been notified by the FDA Department of Health and Human
Services that its rabies monoclonal antibody cocktail has been granted a
Fast Track designation. Crucell is developing this human monoclonal
antibody cocktail for the post-exposure prophylaxis of rabies, using its
MAbstract(R) and PER.C6(R) technologies.
o HUMAN MONOCLONAL ANTIBODIES AGAINST H5N1: The discovery of a set of human
monoclonal antibodies that provides immediate protection and neutralizes
the broadest range of H5N1 strains. These results, demonstrating the
potential of human monoclonal antibodies for pandemic preparedness, were
presented on September 27th, 2007 at the 5th International Bird Flu Summit
held in Las Vegas, Nevada. A total of twenty one human monoclonal
antibodies were discovered. These were found to be able to neutralize the
H5N1 virus of avian influenza, which currently presents a global threat.
The most potent of the antibodies was shown to neutralize the broadest
range of H5N1 strains that have emerged between 1997 and 2004. This
antibody may therefore provide a powerful tool in pandemic preparedness. In
addition, this antibody prevents flu, in pre-clinical models, when given
twenty four hours before a challenge with a lethal dose of highly
pathogenic H5N1 virus. When given three days after infection, it also was
shown to prevent death and cure the disease.
o BLOOD COAGULATION FACTOR VL/C (REDUCING BLOOD CLOTTING TIME FOR
HAEMOPHILIACS): An update on this program will be communicated in the first
quarter of 2008.
NEW MANUFACTURING AGREEMENT
o Crucell and DSM Biologics, a business unit of DSM Pharmaceutical Products
signed a Biopharmaceutical Manufacturing Agreement for production on the
basis of the PER.C6(R) manufacturing platform of Crucell's proprietary
antibody cocktail, which Crucell is developing against rabies. Under the
terms of the agreement, Crucell has contracted DSM Biologics, its alliance
partner for the PER.C6(R) manufacturing platform, for the process
validation and manufacturing of antibody batches for Phase III clinical
efficacy studies. The services will be provided out of DSM Biologics'
FDA-approved manufacturing facility in Groningen, The Netherlands.
LICENSING AGREEMENTS
o Crucell and DSM Biologics announced a non-exclusive PER.C6(R) research
licensing agreement with Moscow, Russia-based MASTERCLONE. Masterclone will
use Crucell's technology to develop an undisclosed antibody. No financial
details were disclosed.
o Crucell and DSM Biologics announced a non-exclusive PER.C6(R) research
licensing agreement with LFB BIOTECHNOLOGIES. LFB Biotechnologies will use
Crucell's technology to develop undisclosed antibodies. No financial
details were disclosed. During the research license period, Crucell and LFB
Biotechnologies will also evaluate a joint collaboration in the field of
enhancing sugar structures, described as glycosylation patterns, on
recombinant antibodies using LFB's in-house development technology.
o Crucell announced that it has entered into a co-exclusive PER.C6(R) and
Advac(R) technology license agreement with WYETH PHARMACEUTICALS, a
division of Wyeth (NYSE: WYE). Under the terms of the agreement, Crucell
will receive an upfront payment, milestone payments, annual maintenance
fees, and royalties on net product sales. Other financial details were not
disclosed.
o Crucell announced a non-exclusive STAR(R) research license agreement with
INVITROGEN CORPORATION's PD-Direct(TM) Bioprocess Services. The license
with Carlsbad, California based Invitrogen covers the production of
monoclonal antibodies. No financial details were disclosed.
o Crucell announced that MERCK & CO., INC. has exercised an option for the
exclusive use of Crucell's PER.C6(R) technology and an option for access to
Crucell's AdVac(R) vaccine technology in two infectious disease areas. This
agreement further broadens the number of disease areas in which our
technologies are used. Under the terms of the agreement, Crucell acquires
rights to certain cell-line technologies developed by Merck for the
manufacture of recombinant proteins. The option and the related rights to
certain technologies developed by Merck originate from the cross-license
agreement executed in December 2006 between Crucell and Merck. Specifics
concerning the infectious disease indications and financial details remain
undisclosed.
APPOINTMENTS
o Dr. Cees de Jong was appointed Chief Operating Officer and serves as a
member of Crucell's Management Committee. Prior to joining Crucell, Dr. de
Jong was Group Vice President in charge of the Flavours Division at Quest
International in the Netherlands. He was a member of Quest International's
Management Board.
PATENTS
o One STAR(R) patent (STAR67, used in STAR constructs) granted in Europe.
o A PER.C6(R) protein production (fed batch) method patent granted in the
U.S.
o An important AdVac-related patent granted in the U.S.
o Position in the AdVac field strengthened further with patents in the U.S.
and in South Korea for the widely used Ad35 vector.
o U.S. patent protection secured for our anti WNV antibodies.
POST BALANCE SHEET EVENTS
o CRUCELL AND MEDIMMUNE announced an exclusive license and research
collaboration agreement for the treatment and prevention of
hospital-acquired bacterial infection. Under the terms of the agreement,
MedImmune is to provide Crucell certain upfront, annual and milestone
payments potentially exceeding US$ 40 million, plus research and
development (R&D) funding and an undisclosed royalty on product sales. In
return, Crucell has granted MedImmune an exclusive license to research,
develop and commercialize antibodies within one of its MAbstract(R)
technology programs. In addition MedImmune will have access to Crucell's
antibody capabilities for further R&D.
o CRUCELL AND DSM BIOLOGICS announced a non-exclusive PER.C6(R) research
licensing agreement with Recepta Biopharma S.A. This agreement allows
Recepta Biopharma S.A. to use Crucell's PER.C6(R) technology to develop
four antibodies it has licensed-in from the Ludwig Institute for Cancer
Research. Financial details were not disclosed.
o CRUCELL announced the completion of a marketing and distribution agreement
with SANQUIN, the Dutch Blood Supply Foundation. Under the terms of the
agreement, Crucell will get exclusive distribution rights of Cofact(R) -
Sanquin's prothrombin complex of blood factors II, VII, IX and X which is
currently in MRP (mutual recognition procedure) registration - in a number
of Crucell's key markets including Norway, Sweden, Denmark, Spain and
Italy. Crucell will also have a right of first refusal for China, Korea and
a number of Eastern European countries.
o CRUCELL announced that Berna Biotech AG, its wholly owned subsidiary, has
sold all the 2.9 million shares it owned in PEVION BIOTECH Ltd, Bern
(Switzerland) to other shareholders of Pevion Biotech Ltd. This resulted in
net proceeds of approximately CHF 10 million ((euro)6 million).
FINANCIAL REVIEW
TOTAL REVENUE AND OTHER OPERATING INCOME
Total revenue and other operating income was (euro)62.6 million for the third
quarter of 2007, an increase of 115% compared to the same quarter last year. The
autonomous growth, excluding acquisitions, amounted to 87%, mainly driven by the
continued success of Quinvaxem(TM) and sales of our Flu product Inflexal(R) V,
which are traditionally weighted to the second half of the year.
For the nine month period ending September 30, 2007, total revenue and other
operating income was (euro)137.2 million. In constant currencies this is
(euro)140.6 million.
Product sales amounted to (euro)55.2 million and represent sales of pediatric
vaccines (42%), travel vaccines (19%), respiratory/flu (33%) and other products
(6%). Product sales are seasonal and have historically been concentrated in the
second half of the year, driven mainly by influenza vaccines sales. In addition,
increased revenues from Quinvaxem(TM) are expected in the fourth quarter of this
year.
License revenues were (euro)1.8 million in the third quarter, a decline of
(euro)0.2 million compared to the same quarter last year. License revenues
consist of initial payments from new contracts as well as annual and other
payments on existing contracts. No significant initial fees were received during
the third quarter.
Service fees for the quarter were (euro)3.7 million, compared to (euro)1.8
million last year. Service fees represent revenue for product development
activities performed under contracts with partners and licensees.
Other operating income was (euro)1.9 million for the quarter, compared to
(euro)3.2 million in the third quarter last year. Other operating income
consists primarily of government grants and miscellaneous income.
COST OF GOODS SOLD
Cost of goods sold for the third quarter of 2007 amounted to (euro)38.9 million,
(euro)35.5 million of which represents product costs and the remainder of
(euro)3.4 million the cost of service activities. Cost of goods sold for the
quarter includes a purchase price allocation accounting charge of (euro)2.2
million. We will charge this amount to cost of goods sold when we sell the
underlying acquired inventory. The charge is the result of the fair value
established for inventory at acquisition dates.
EXPENSES
Total expenses consist of research and development (R&D) expenses, and selling,
general and administrative (SG&A) expenses. Total R&D and SG&A expenses were
(euro)27.6 million for the third quarter, representing a (euro)2.1 million
decline over the same period last year.
R&D expenses for the third quarter amounted to (euro)12.3 million, which
represents a (euro)6.6 million decline versus the third quarter of 2006. This
decrease can be attributed to capitalization validation expenses of the new
Leiden facility, thereby reducing R&D expenditure by (euro)3.6 million. The
decrease can also be attributed to the optimization of R&D activities following
the reorganization at the end of last year and the timing of specific R&D
expenses during the year.
SG&A expenses for the third quarter of 2007 were (euro)15.2 million and
represent an increase of (euro)4.6 million over the same quarter in 2006, which
is mainly attributed to higher selling and marketing expenses.
For the nine month period ending September 30, 2007, R&D expenses are (euro)45.7
million. SG&A expenses for the nine month period ending September 30, 2007
amount to (euro)48.0 million and consist of selling and marketing expenses
((euro)25.2 million) and general and administrative expenses ((euro)22.8
million). Selling and marketing expenses increased (euro)14.6 million over the
same nine month period last year due to inclusion of costs related to Berna
Biotech, SBL and Crucell Vaccines in the US. G&A expenses in the first nine
months rose (euro)3.9 million over the same period last year driven by
compliance, advisory costs and equity based compensation costs.
NET LOSS
The Company reported a net loss (euro)4.5 million for the third quarter of 2007
compared to (euro)21.7 million in the same period last year. This amounted to
(euro)0.07 net loss per share, compared to a net loss per share of (euro)0.36 in
the third quarter of 2006.
BALANCE SHEET
Property plant and equipment amounted to (euro)142.1 million on September 30,
2007. Intangible assets represent assets acquired in acquisitions and amount to
(euro) 99.0 million. This amount represents acquired in-process R&D; developed
technology; patents and trademarks; and value of customer and supplier
relationships.
Investments in associates and joint ventures amount to (euro)13.5 million and
represent investments in Pevion, Kenta and PERCIVIA. The Company's investment in
Galapagos NV is classified under available-for-sale investments.
Total equity on September 30, 2007 amounted to (euro)443.9 million. A total of
65,194,946 million ordinary shares were issued and outstanding on September 30,
2007.
CASH FLOW AND CASH POSITION
Cash and cash equivalents decreased by (euro)23.8 million in the third quarter
to (euro)107.0 million.
Net cash used in operating activities in the third quarter of 2007 was (euro)5.5
million.
Overall net working capital rose due to an increase of (euro)22.4 million in
accounts receivable related to a high level of vaccine sales in the third
quarter, and a (euro)9.7 million decrease in accounts payable. This is partly
offset by a decrease in inventory by (euro)10.0 million, reflecting the
shipments of the flu vaccine Inflexal(R) V.
In the third quarter net cash used in investing activities amounted to
(euro)17.7 million. This primarily consists of capital expenditure of (euro)10.1
million and investments in financial assets of (euro)9.0 million (mainly
AdImmune), partly offset by (euro)1.4 million in interest received.
In the quarter, net cash used in financing activities amounted to (euro)0.4
million, consisting of a repayment of financial liabilities and the proceeds
from shares issued for stock options exercised.
OUTLOOK
Crucell expects combined full year 2007 total revenue and total other operating
income in the (euro)220 to (euro)225 million range. The Company aims to achieve
cash break-even on its 'net cash from operating activities' line in the cash
flow statement for the full year 2007.
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 June 13, 2007, and the section entitled "Risk Factors". The
Company prepares its financial statements under International Financial
Reporting Standards (IFRS) with reconciliation to the generally accepted
accounting principles in the United States (US GAAP).
Conference Call and Webcast
Today at 14:00 Central European Time, Crucell will conduct a conference call
open to all, which will also be webcast. To participate in the conference call,
please call one of the following numbers 10 minutes prior to commencement:
1 888 457 4228 for the US;
0800-358 0886 for the UK; and
0800-265 8546 for the Netherlands
Following a presentation of the results you will be able to ask questions during
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 biotechnology
company focused on research, development and worldwide marketing of vaccines and
antibodies that prevent and 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 aluminium-free hepatitis A vaccine on the
market. The Company has a broad pipeline, with several products based on its
unique PER.C6(R) production technology in development. The Company licenses this
and other technologies to the biopharmaceutical industry. Important partners and
licensees include DSM Biologics, sanofi aventis, Novartis, Wyeth and Merck & Co.
Crucell is headquartered in Leiden (the Netherlands), with subsidiaries in
Switzerland, Spain, Italy, Sweden, Korea and the US. The Company employs more
than 1000 people. For more information, please visit www.crucell.com
FINANCIAL CALENDAR:
12 February 2008 Q4 Results 2007
13 May 2008 Q1 Results 2008
30 May 2008 Annual General Meeting of Shareholders
12 August 2008 Q2 Results 2008
11 November 2008 Q3 Results 2008
17 February 2009 Q4 Results 2008
FOR FURTHER INFORMATION PLEASE CONTACT:
MEDIA: INVESTORS/ANALYSTS:
Crucell N.V. Crucell N.V.
Barbara Mulder Oya Yavuz
Director Corporate Communications Director Investor Relations
Tel: 31-(0)71 519 7346 Tel. +31-(0)71-519 7064
press@crucell.com ir@crucell.com
www.crucell.com www.crucell.com
CONSOLIDATED STATEMENTS OF OPERATIONS
- --------------------------------------------------------------------------------------------------------------------
in EUR '000 (except per share data)
- --------------------------------------------------------------------------------------------------------------------
THIRD QUARTER 9 MONTHS ENDED
SEPTEMBER 30,
- --------------------------------------------------------------------------------------------------------------------
2007 2006 2007 2006
UNAUDITED UNAUDITED UNAUDITED UNAUDITED
----------- ----------- ----------- -----------
Product sales 55,163 22,004 114,040 43,497
License revenues 1,780 1,992 6,046 6,630
Service fees 3,697 1,844 9,026 6,357
----------- ----------- ----------- -----------
TOTAL REVENUE 60,640 25,840 129,112 56,484
Cost of product sales -35,513 -19,015 -78,700 -43,208
Cost of service fees -3,365 -1,799 -6,898 -4,991
----------- ----------- ----------- -----------
TOTAL COST OF GOODS SOLD -38,878 -20,814 -85,598 -48,199
GROSS MARGIN 21,762 5,026 43,514 8,285
Government grants 1,022 2,581 5,627 5,588
Other income 910 657 2,429 2,418
----------- ----------- ----------- -----------
TOTAL OTHER OPERATING INCOME 1,932 3,238 8,056 8,006
Research and development -12,316 -18,943 -45,704 -48,734
Selling, general and administrative -15,240 -10,677 -48,029 -29,490
----------- ----------- ----------- -----------
TOTAL OTHER OPERATING EXPENSES -27,556 -29,620 -93,733 -78,224
OPERATING LOSS -3,862 -21,356 -42,163 -61,933
Financial income 2,701 4,259 9,349 9,235
Financial expenses -3,307 -3,374 -7,943 -7,953
Results investments non-consolidated companies -655 -467 -1,182 -1,258
Results from discontinuing operations 0 0 0 0
----------- ----------- ----------- -----------
LOSS BEFORE TAX -5,123 -20,938 -41,939 -61,909
Income tax 635 -783 769 -784
----------- ----------- ----------- -----------
LOSS FOR THE PERIOD -4,488 -21,721 -41,170 -62,693
=========== =========== =========== ===========
Attributable to:
Equity holders of the parent -4,488 -21,557 -41,170 -61,985
Minority interest 0 -164 0 -708
----------- ----------- ----------- -----------
-4,488 -21,721 -41,170 -62,693
=========== =========== =========== ===========
Net loss per share - basic and diluted -0.07 -0.36 -0.63 -1.12
Weighted average shares outstanding - basic and diluted 65,195 59,104 65,026 55,562
CONSOLIDATED BALANCE SHEETS
- --------------------------------------------------------------------------------------------------------------------
in EUR '000
- --------------------------------------------------------------------------------------------------------------------
SEPTEMBER 30 JUNE 30
- --------------------------------------------------------------------------------------------------------------------
2007 2007
UNAUDITED UNAUDITED
----------- -----------
ASSETS
NON-CURRENT ASSETS
Plant and equipment, net 142,126 136,975
Intangible assets 98,961 103,888
Goodwill 44,914 48,112
Investments in associates and joint ventures 13,508 5,312
Net pension asset 2,476 2,483
Available-for-sale investments 8,468 10,505
Other financial assets 16,157 16,087
Deferred tax assets 305 310
----------- -----------
326,915 323,672
CURRENT ASSETS
Cash and cash equivalents 106,983 130,810
Trade accounts receivables 49,483 27,765
Inventories 74,970 86,027
Other current assets 25,150 25,925
----------- -----------
256,586 270,527
TOTAL ASSETS 583,501 594,199
=========== ===========
LIABILITIES AND EQUITY
EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE PARENT
Share capital 15,647 15,616
Other reserves 739,649 740,424
Translation reserve -22,996 -16,120
Accumulated deficit -288,418 -284,240
----------- -----------
Total equity 443,882 455,680
NON-CURRENT LIABILITIES
Long-term financial liabilities 27,302 27,948
Long-term provisions 5,470 5,260
Deferred tax liabilities 31,359 32,709
----------- -----------
64,131 65,917
CURRENT LIABILITIES
Accounts payable 18,808 29,035
Short-term financial liabilities 18,499 19,371
Other current liabilities 37,279 23,248
Income tax payable 537 360
Short-term provisions 365 588
----------- -----------
75,488 72,602
TOTAL LIABILITIES 139,619 138,519
TOTAL LIABILITIES AND SHAREHOLDER'S EQUITY 583,501 594,199
=========== ===========
CONSOLIDATED STATEMENTS OF CASH FLOW
- --------------------------------------------------------------------------------------------------------------------
in EUR '000
- --------------------------------------------------------------------------------------------------------------------
THIRD QUARTER 9 MONTHS ENDED
SEPTEMBER 30,
- --------------------------------------------------------------------------------------------------------------------
2007 2006* 2007 2006*
UNAUDITED UNAUDITED UNAUDITED UNAUDITED
----------- ----------- ----------- -----------
CASH FLOWS FROM/(USED IN) OPERATING ACTIVITIES
Loss for the period -4,488 -21,721 -41,170 -62,693
Reversal of non-cash items
Tax -636 783 -770 784
Results investments non-consolidated companies 655 466 1,182 1,258
Financial income -2,700 -4,259 -9,349 -9,235
Financial expenses 3,307 3,374 7,943 7,953
Depreciation 3,860 4,014 10,687 10,000
Amortization 3,012 1,968 9,131 4,500
Fair value write-down on Inventory 2,559 0 6,157 0
Change in long-term provisions 215 -85 32 141
Gain on disposal of assets 2 48 -66 -172
Stock based compensation 1,395 1,980 4,784 3,868
Change in net working capital
Trade accounts receivable -22,427 -7,756 7,437 -5,783
Inventories 10,027 -3,048 -6,146 -9,684
Other current assets -950 121 1,874 6,503
Trade accounts payable -9,746 -3,782 -18,307 6,734
Other current liabilities 11,542 2,262 2,853 -5,411
Short-term provisions -68 -157 -1,230 -213
Interest paid -742 -272 -2,072 -970
Income taxes paid -205 -837 -1,049 -314
Payments out of provisions -146 -51 -1,256 -106
----------- ----------- ----------- -----------
NET CASH FROM/(USED IN) OPERATING ACTIVITIES -5,534 -26,952 -29,335 -52,840
Cash flows from/(used in) investing activities
Purchase of property, plant and equipment -10,118 -7,071 -18,598 -16,045
Proceeds from sale of equipment 59 255 149 413
Proceeds from disposal of intangible assets 0 0 11 225
Acquisition/Disposal of subsidiaries net of cash 0 63 0 68,088
Investments / Capital increase in Joint ventures 0 -12,227 0 -12,227
Assets classified as held for sale 0 -12 0 11,793
Investments in financial assets -9,034 -11,526 -8,376 -3,507
Interest received 1,442 690 4,477 2,505
----------- ----------- ----------- -----------
NET CASH FROM/(USED IN) INVESTING ACTIVITIES -17,651 -29,828 -22,337 51,245
Cash flows from/(used in) financing activities
Proceeds from issue of share capital 209 -11 1,601 3,406
Proceeds from financial liabilities 85 1,261 2,377 9,997
Repayment of finanical liabilities -682 118 -1,432 -936
----------- ----------- ----------- -----------
NET CASH FROM (USED IN) FINANCING ACTIVITIES -388 1,368 2,546 12,467
Effects of exchange rate on cash and cash equivalents -254 14 -1,728 -331
----------- ----------- ----------- -----------
NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS -23,827 -55,398 -50,854 10,541
Cash and cash equivalents at beginning of period 130,810 177,673 157,837 111,734
----------- ----------- ----------- -----------
CASH AND CASH EQUIVALENTS AT END OF PERIOD 106,983 122,275 106,983 122,275
=========== =========== =========== ===========
* Certain comparatives were reclassified to conform with current period's
presentation.
SIGNATURES
Pursuant to the requirements of the Securities Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
CRUCELL NV
-----------------------------------------
(Registrant)
November 14, 2007 /s/ LEON KRUIMER
- ------------------------ -----------------------------------------
(Date) Leon Kruimer
Chief Financial Officer