Nov. 3, 2009 (Hugin AS) -- 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 (NASDAQ:CRXL) 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.
