surf1944
15 years ago
Johnson & Johnson buys 18 percent stake in Crucell
Johnson & Johnson takes 18 percent stake in Crucell for euro301.8 million
By Toby Sterling, AP Business Writer
On Monday September 28, 2009, 9:25 am EDT
Companies:Johnson JohnsonPfizer Inc.Wyeth
AMSTERDAM (AP) -- U.S. health care products maker Johnson & Johnson Inc. has bought an 18 percent stake in Dutch biotechnology company Crucell NV for euro301.8 million ($440 million) in hopes of developing a universal flu vaccine, the companies said Monday.
In a joint statement, the companies said their immediate focus would be on developing a flu treatment in the form of "monoclonal antibodies" -- which bind to a target protein, alerting the body's own immune system to attack it.
The Leiden, Netherlands-based Crucell was awarded grants worth up to $69 million by the U.S. government in August to develop its range of monoclonal antibodies for influenza, which Crucell says have shown early promise in fighting "a wide range" of seasonal and pandemic flu viruses.
The company claims the antibodies can fight any influenza, including swine flu and bird flu, and including those flu strains resistant to Tamiflu -- the medicine currently most often used to slow their progression.
"Each year, vaccines must be formulated to address the current influenza strain," said Paul Stoffels, head of Johnson & Johnson research.
"A universal antibody or vaccine that protects against a broad range of strains would be an important advance in helping doctors and nurses manage the annual influenza season and control acute epidemic and pandemic outbreaks."
New Brunswick, New Jersey-based Johnson & Johnson is one of the world's largest medical companies but is not one of the top 5 vaccine makers.
Crucell CEO Ronald Brus said his company was overwhelmed with interest after they published results in Science magazine showing the treatment's potential, but Johnson & Johnson offered a deal that preserved a fair share of future profits for Crucell.
In addition, he said Crucell didn't want to partner with any of the top 5 players in the vaccine market because they make large amounts of money from selling annual flu vaccines and so would have conflicting interests.
"You want to partner with the one that wants to enter the market, not the ones that want to defend their market," he said.
Under the deal, Crucell will retain the right to market products the companies develop jointly in Europe, while Johnson & Johnson will market them in the rest of the world.
Crucell will receive additional royalties and payments from Johnson & Johnson "worth hundreds of millions," Brus said, if the flu cure is marketed.
Crucell said the shares it is selling to Johnson & Johnson are newly created.
Shares in Crucell were up 3 percent at euro16.43 in midday trading in Amsterdam.
Johnson & Johnson said the purchase would reduce its per-share earnings by $0.02 - $0.04 in 2009.
Besides a universal flu vaccine, Crucell and Johnson & Johnson said they hope to use similar antibodies to fight three other diseases, although they did not yet specify which.
Earlier this year Wyeth entered talks to buy Crucell for $1.35 billion, but it canceled the negotiations after Wyeth itself was bought for $68 billion by Pfizer Inc.
The agreement with Johnson & Johnson specifies that the U.S. company won't buy any more of Crucell's shares for 3 years without Crucell's consent.
surf1944
16 years ago
Crucell's 2Q loss narrows on higher vaccine sales
Tuesday August 12, 12:49 pm ET
Crucell's 2nd-quarter loss narrows on boost in vaccine sales; co. backs full-year expectations
NEW YORK (AP) -- Dutch biotechnology company Crucell NV said Tuesday its second-quarter loss narrowed on higher sales of pediatric vaccines and increased licensing fees.
However, Crucell's American Depository Shares fell as the company reported a smaller margin, citing variation in its product mix during the quarter. The stock lost $1.24, or 6.8 percent, to $16.90 in midday trading. The stock has traded between $12.76 and $22.72 over the last 52 weeks.
Early Tuesday, the company said it lost 7.9 million euros ($12.5 million), or 12 euro cents per share (20 cents), compared with a loss of 18.2 million euros, or 28 euro cents per share, in the year-ago quarter. Revenue jumped 51 percent to 59.6 million euros ($94.2 million) from 39.4 million euros.
"In the second quarter of 2008 we saw strong growth of our pediatric vaccines, driven by Quinvaxem," said Chief Executive Ronald Brus, in a statement. "This innovative, fully-liquid pentavalent vaccine was described by the World Health Organization (WHO) as one of the most advanced immunization products available, enabling countries to make a large stride toward their health targets."
Crucell's margin fell to 36 percent from 39 percent a year earlier.
In the second half of the year, the company expects flu vaccine sales to drive the margin higher. Overall, it expects higher margins for the full year compared with 2007 on revenue growth of about 20 percent.
surf's up......crikey
surf1944
16 years ago
Crucell Announces Second Quarter 2008 Results
Tuesday August 12, 1:55 am ET
LEIDEN, NETHERLANDS--(MARKET WIRE)--Aug 12, 2008 -- Total revenue and other operating income increased by 51% to EUR 59.6 million, compared to EUR 39.4 million in the second quarter of 2007. Solid gross margins of 36% and significantly reduced net loss for the second quarter to EUR 7.9 million compared to EUR 18.2 million in Q207. 2008 full year guidance reiterated: total revenue and other operating income growth of 20% in constant currencies[1]; higher margins; positive cash flow.
Leiden, The Netherlands (August 12, 2008) - Dutch biopharma company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) today announced its financial results for the second quarter of 2008, based on International Financial Reporting Standards (IFRS). These financial results are unaudited.
Highlights:
* DSM Biologics and Crucell announced another breakthrough in the
production of IgG antibodies using Crucell's PER.C6® technology.
By employing the PER.C6® human cell line and proprietary XD(TM)
technology, a record yield of over 27 grams per liter has been
achieved.
* Product sales increased driven by continued growth of paediatric
and travel vaccines; in particular Quinvaxem®, Epaxal® and
Dukoral®.
* Crucell's rabies monoclonal antibody cocktail entered a second
Phase II clinical trial in the Philippines in May 2008.
Preliminary results of Crucell's U.S. Phase II study are expected
to be presented on October 1 at the 19th annual RITA meeting in
Atlanta.
* Crucell announced three non-exclusive STAR® research license
agreements; with Bioceros, covering the production of monoclonal
antibodies; with Celltrion, Inc. for the manufacturing of
biopharmaceuticals and with Toyobo Gene Analysis Co. LTD. for
the production of recombinant proteins for third-party customers.
* DSM Biologics and Crucell announced to have entered into an
agreement with Avid Bioservices to join their Vendor Network.
* Crucell's operational excellence program "Healthy Ambition" is
being rolled out at full steam. Target savings of EUR 30 million by
the end of 2009.
* Initial net cost savings of EUR 3 million expected in the second
half of 2008.
* Crucell's shareholders appointed Mr. Steve Davis as member of the
Supervisory Board at the Annual Meeting for Shareholders, held in
May. Dr. Cees de Jong was appointed as a member of the Board of
Management for a term of four years.
Financial Highlights:
* Combined total revenue and other operating income for the quarter
of EUR 59.6 million compared to EUR 39.4 in the same quarter of 2007.
The increase of 51% (63% in constant currencies) was driven by
strong sales of paediatric vaccines, in particular by Quinvaxem®,
higher sales of travel vaccines as well as higher license fees.
* Increase of license revenues driven by milestone payments as a
result of the start of two phase II clinical studies of Crucell's
rabies monoclonal antibody cocktail.
* Gross margins of 36% compared to 39% in the second quarter of
2007 due to a variation in the product mix in this quarter. Gross
margins in the second half of 2008 are expected to be positively
influenced by the seasonality of our flu product (Inflexal® V) in
particular.
* Net loss in the second quarter of 2008 narrowed by 57% to EUR 7.9
million versus a net loss of EUR 18.2 million in the same quarter of
2007.
* Cash and cash equivalents at the end of the second quarter
amounted to EUR 106.9 million versus EUR 163.2 million at year-end
2007. Deterioration of cash flow and working capital in the
second quarter of 2008 was due to the seasonality of our
business, in which we build inventory in the first half of the
year to sell our products in the second half of the year. Full
year expectations of positive cash flow are reiterated.
* Net cash used in operating activities in the second quarter of
2008 was EUR 18.0 million compared to net cash used in operating
activities of EUR 10.2 million in the same quarter of 2007.
Key Figures Q2 2008:
(EUR million, except net loss per share)
Second Quarter Six months ended June 30
2008 2007 Change 2008 2007 Change
Total revenues and
other operating
59.6 39.4 51% income 107.5 74.6 44%
(7.9) (18.2) (57%) Net loss (16.9) (36.7) (54%)
Net loss per share
(0.12) (0.28) (basic and diluted) (0.26) (0.57)
Cash & cash equiv.:
- June 30, 2008 106.9
- Dec 31, 2007 163.2
ADVERTISEMENT
Crucell's Chief Executive Officer Ronald Brus said:
"In the second quarter of 2008 we saw strong growth of our paediatric vaccines, driven by Quinvaxem®. This innovative, fully-liquid pentavalent vaccine was described by the World Health Organization (WHO) as 'one of the most advanced immunization products available, enabling countries to make a large stride towards their health targets'. We are very proud to have this product in Crucell's paediatric portfolio and expect to see continued growth going forward."
"Our travel and endemic vaccines, in particular Epaxal® and Dukoral®, also showed solid growth compared to the second quarter of 2007. We will continue to go after untapped markets, amongst others in the U.S., to expand our geographical presence of our travel and endemic vaccines."
"Together with DSM Biologics we achieved another breakthrough in the production of IgG antibodies using Crucell's PER.C6® technology. A record yield of over 27 grams per liter was achieved, which surpasses all other production systems currently available in the market."
"We are rolling out our operational excellence program Healthy Ambition at full steam. As an integral part of our growth strategy, Healthy Ambition's goal is to improve overall business performance and reduce costs with 15% by the end of 2009 resulting in an overall run-rate of EUR 30 million savings."
"In the first half of the year we also started two Phase II clinical studies (in the U.S and in the Philippines) for our Rabies Monoclonal Antibody Cocktail, a collaboration with sanofi pasteur using Crucell's PER.C6® technology. The Rabies Monoclonal Antibody Cocktail is to be used in combination with rabies vaccines for post-exposure prophylaxis against this fatal disease. Preliminary results of our U.S. study are expected to be presented in the U.S. on October 1 at the 19th annual RITA meeting in Atlanta."
"Based on our second quarter results we reiterate our guidance of combined total revenue and total other operating income for the full year 2008 to grow by 20%[1]. We further expect higher margins and positive cash flow."
Product and Business Update:
Product Update
Product sales for the second quarter of 2008 amounted to EUR 48.4 million and represent sales of paediatric vaccines (56%), travel & endemic vaccines (29%) and other products (15%).
Paediatric
In the second quarter of 2008 we saw good growth of our paediatric vaccines, 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 for children against hepatitis A. The
product is currently under registration in selected countries
worldwide. Sales in South America have started and European
launch is being planned.
* MoRu-Viraten®: Vaccine for protection against measles and rubella
(for all age groups).
Travel and Endemic
The second quarter of 2008 showed continued growth of our travel and endemic portfolio, where Epaxal® and Dukoral® in particular showed growth compared to the second quarter of 2007. We continue to see significant untapped demand and geographical expansion potential of our travel portfolio.
* Epaxal®: The only aluminium-free vaccine against hepatitis A.
* Vivotif®: The only oral vaccine against typhoid fever.
* Dukoral®: The only oral vaccine against diarrhea caused by
cholera and ETEC (enterotoxigenic E.coli).
Respiratory
* 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 the
respiratory products in the second half of the year.
Pipeline Update
* Flavimun® - Live Attenuated Yellow Fever Vaccine: Crucell's
management expects the registration submission of the Yellow
Fever vaccine in Switzerland before the end of 2008.
* Influenza - Seasonal Flu Vaccine (FluCell collaboration with
sanofi pasteur): The seasonal influenza vaccine 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. Phase II trials involving healthy
adult volunteers in the U.S. focus on the safety profile and
immunogenicity of the cell-based vaccine.
* Influenza - H9N2 Pandemic Flu Vaccine: Completed in July 2008.
Phase I and II studies were carried out and no serious adverse
side effects were reported. In the H9N2 trial Crucell's licensed
vaccine method, i.e. a virosomal vaccine was compared to methods
less suitable for seasonal vaccine production. As expected the
immune response to the unlicensed whole virus vaccine, in
particular when adjuvanted with aluminium, appeared to be the
most suitable way to induce immunity against a pandemic H9N2
influenza strain and possibly H5N1 strains. Results from this
trial showed that subjects who were vaccinated with the virosomal
vaccine less frequently reported pain as compared to subjects who
were vaccinated with whole virus (with or without adjuvation). We
have recently shown (Radosevic et al., Vaccine 2008; 26: 3640-46)
that our licensed strategy for seasonal influenza vaccination
could also be used for pandemic influenza strains when the immune
response was enhanced by additional adjuvants. Within the
PanFluVac EU consortium this approach will be tested for a
virosomal H5N1 vaccine in humans in 2009.
* Rabies Human Monoclonal Antibody Cocktail: Crucell's rabies
monoclonal antibody cocktail, a collaboration with sanofi pasteur
using Crucell's PER.C6® manufacturing technology, has entered two
Phase II clinical trials (in the US and in the Philippines). The
start of these Phase II studies triggered the first milestone
payments of a total of up to EUR 66.5 million. This antibody
cocktail is to be used in combination with a rabies vaccine for
post-exposure prophylaxis against this fatal disease. Based on
promising Phase I data in 2007, showing no serious adverse
effects and well tolerated treatment, Crucell was granted a Fast
Track designation by the FDA Department of Health and Human
Services. Crucell will be responsible for the 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.
Preliminary results of our U.S. study are expected to be
presented in the U.S. on October 1 at the 19th annual RITA
meeting in Atlanta, at the Centers of Disease Control and
Prevention.
* Malaria Vaccine based on AdVac®/PER.C6® Technology: Crucell and
its partner, the 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 on two sites, VanderBilt and Stanford
University. The first three cohorts, comprising of 18, 17 and 18
volunteers respectively, have been enrolled. Enrollment for the
fourth and final group of volunteers is expected to start soon.
Initial findings of this Phase I trial are expected to be
available in 2008.
* Tuberculosis Vaccine based on AdVac®/PER.C6® Technology: The
development of this vaccine is being carried out in collaboration
with the Aeras Global TB Vaccine Foundation. A US Phase I trial
(in BCG naïve individuals) has been completed, indicating that
the vaccine candidate is safe in healthy adults in the US. The
results of a second study which took place in South Africa,
launched in May 2007, were presented in April at the
'Tuberculosis Vaccines for the World' conference in Atlanta.
Preliminary data show encouraging results, whereby CD8 immune
responses are considerably higher than previously ever seen in a
tuberculosis vaccine study. A third phase I study in healthy
adults in St. Louis, US was launched in December 2007 and 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.
* Ebola Vaccine based on AdVac®/PER.C6® Technology: For the Phase I
study for the Ebola vaccine, which Crucell is developing in
partnership with the Vaccine Research Center (VRC) of the
National Institute of Allergy and Infectious Diseases (NIAID),
two groups of 16 volunteers have been enrolled and vaccinated.
The clinical data is still blinded, however initial indications
suggest that the vaccine is safe at the tested doses and appears
to be immunogenic in a subset of subjects.
* Blood Coagulation Factor VL/C: Preclinical work on this program
continues but conclusive proof of concept is not expected in the
near future.
* HIV Vaccine based on AdVac®/PER.C6® Technology: 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
that the novel recombinant vaccine (using the adenovirus serotype
26 (rAd26) as vector), which is jointly developed with the Beth
Israel Deaconess Medical Center (BIDMC), has gone into a Phase I
clinical study to test a new HIV vaccine. 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 (BWH) in Boston and is focused on assessing the safety
and immunogenicity of the vaccine. The study involves 48 healthy
volunteers.
* H5N1 - Human Monoclonal Antibodies against Flu: Crucell's
scientists discovered a set of 21 human monoclonal antibodies
that provides immediate protection and neutralizes the broadest
range of H5N1 strains in preclinical models. 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
prevents flu, in pre-clinical models, when given twenty four
hours before a challenge with a lethal dose of the pathogenic
H5N1 virus. When given three days after infection, it also was
shown to prevent death and cure the disease. Therefore this
antibody may provide a powerful tool in pandemic preparedness.
Healthy Ambition:
* After a phase of thorough analysis and business process redesign,
the operational excellence program Healthy Ambition is now being
rolled out into Crucell. Important elements of the program are:
product portfolio optimization, process and infrastructure
optimization, network rationalization and further integration and
streamlining of various functions. Target savings of EUR 30 million
are expected to be achieved by the end of 2009. In the second
half of 2008 net savings of EUR 3 million are expected.
PER.C6® technology platform:
* DSM Biologics and Crucell announced another breakthrough in the
production of IgG antibodies using Crucell's PER.C6® technology.
By employing the PER.C6® human cell line and proprietary XD(TM)
technology, a record yield of over 27 grams per liter has been
achieved. In March 2008 a yield of 15 grams per liter was
reported. This milestone is the new manufacturing paradigm for
mammalian cell culture to produce protein products effectively,
where the industry has struggled to date with low yields and
unstable platforms. This record surpasses all other production
systems including those previously set by PER.C6® technology
itself.
Licensing Agreements:
* Crucell announced a non-exclusive STAR® research license
agreement with Bioceros. The license agreement covers the
production of monoclonal antibodies. Financial details of the
agreement were not disclosed.
* Crucell announced a non-exclusive STAR® research license
agreement with Celltrion, Inc. for the production of recombinant
proteins. Under the agreement, Celltrion will evaluate Crucell's
STAR® technology for generating cell lines for the manufacturing
of biopharmaceuticals. Financial details of the agreement were
not disclosed.
* Crucell announced a non-exclusive STAR® research license
agreement with Toyobo Gene Analysis Co. LTD. Under the agreement,
Toyobo Gene Analysis will evaluate Crucell's STAR® technology for
generating cell lines for the production of recombinant proteins
for third-party customers. Financial details of the agreement
were not disclosed.
Vendor Network:
* DSM Biologics and Crucell announced to have entered into an
agreement with Avid Bioservices, Inc. of Tustin, California to
join their Vendor Network. Under the terms of the agreement, Avid
will be a pre-approved contract manufacturer for licensees of the
PER.C6® cell line located in the western U.S. Avid is the first
U.S.-based contract manufacturer to be awarded this status.
Appointments:
* Crucell's Annual General Meeting of Shareholders (AGM), held in
Leiden on May 30th, approved the resignation of Mr. Dominik
Koechlin as a member of the Supervisory Board. In addition Mr.
Steve Davis was appointed as member of the Supervisory Board for
a term of four years, until 2012.
* As member of the Board of Management the shareholders appointed
Dr. Cees de Jong for a term of four years. The other members of
the Board of Management, Dr. Ronald Brus, Mr. Leonard Kruimer and
Dr. Jaap Goudsmit were re-appointed for a term of four years by
Crucell's shareholders.
Patents: In Q2 2008 Crucell received a total of 25 granted patents, including patents for:
* Methods for producing multiple proteins or multimeric proteins
using STAR® technology, in Australia and the U.S.
* Methods of producing particular antibody fragments in PER.C6®
cells, in Europe.
* Improved methods for the production of viruses using PER.C6®
cells, in Australia.
* Adenoviral vector based malaria vaccines, in the
U.S.
Financial Review
Total Revenue and Other Operating Income
Total revenue and other operating income was EUR 59.6 million for the second quarter of 2008, an increase of 51% compared to the same quarter of 2007 (63% in constant currencies). The increase was driven by continued strong sales of paediatric and travel vaccines as well as higher license fees. Increase of license revenues was driven by milestone payments as a result of the start of two Phase II clinical studies of our Rabies program.
Product sales for the second quarter amounted to EUR 48.4 million and represent sales of paediatric vaccines (56%), travel vaccines (29%) and other products (15%). License revenues were EUR 5.5 million in the second quarter, an increase of EUR 4.0 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 2.3 million, compared to EUR 3.2 million last year. Service fees represent revenue for product development activities performed under contracts with partners and licensees.
Total other operating income was EUR 3.4 million for the quarter, compared to EUR 2.4 million in the second quarter of 2007.
Cost of Goods Sold
Cost of goods sold for the second quarter of 2008 amounted to EUR 35.8 million, EUR 34.0 million of which represents product costs and the remainder of EUR 1.7 million the cost of service and license activities.
Gross operating margins of 36% compared to 39% in the second quarter of 2007 due to a variation in the product mix in this quarter. Gross margins in the second half of 2008 are expected to be positively influenced by the seasonality of our flu product (Inflexal® V) in particular.
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 period were EUR 33.5 million for the second quarter, representing a EUR 1.7 million decrease over the same period in 2007.
R&D expenses for the second quarter amounted to EUR 17.6 million, which represents a EUR 0.8 million increase versus the second quarter of 2007. The increase can be attributed to the timing of specific R&D expenses during the year. Overall R&D spending for the full year is expected to be around EUR 70 million.
M&S expenses for the quarter were EUR 8.1 million, which represents a EUR 1.3 million decrease versus the second quarter of 2007. This decrease was due to higher one-off expenses in the same quarter last year.
G&A expenses for the second quarter of 2008 were EUR 7.8 million and represent a decrease of EUR 1.2 million over the same quarter in 2007, which include costs related to the 'Healthy Ambition' program. Net financial income in the second quarter of EUR 2.3 million was the result of foreign exchange gains mainly caused by the strengthening of the Swiss Franc against the Euro.
Net Loss
The Company reported a net loss of EUR 7.9 million for the second quarter of 2008 compared to EUR 18.2 million in the same period of 2007. This amounted to EUR 0.12 net loss per share, compared to a net loss per share of EUR 0.28 in the second quarter of 2007.
Balance Sheet
Tangible fixed assets amounted to EUR 148.5 million on June 30, 2008. Intangible assets represent assets acquired in acquisitions and amounted to EUR 84.0 million. This figure represents acquired in-process research and development; developed technology; patents and trademarks; and value of customer and supplier relationships.
Investments in associates and joint ventures amount to EUR 8.7 million and mainly represent investments in AdImmune and PERCIVIA. The Company's investment in Galapagos NV is classified under available-for-sale investments. Total equity on June 30, 2008 amounted to EUR 413.3 million. A total of 65.7 million ordinary shares were issued and outstanding on June 30, 2008.
Cash Flow and Cash Position
Cash and cash equivalents decreased by EUR 15.0 million in the second quarter to EUR 106.9 million.
Reduction of cash flow in the second quarter was due to the seasonality of our business, in which we build inventory in the first half of the year to sell our products in the second half of the year.
Net cash used in operating activities in the second quarter of 2008 was EUR 18.0 million. Overall investments in net working capital increased mainly due inventory build-up in preparation for the flu season as well as accounts receivable.
In the second quarter net cash from investing activities amounted to EUR 1.3 million. In the quarter net cash from financing activities amounted to EUR 2.5 million.
Outlook 2008:
Crucell expects combined full year 2008 total revenue and total other operating income to grow by 20% in constant currencies[1]. The Company expects higher margins compared to 2007 and positive cash flow.
Phasing in 2008:
We expect revenues and operating income to be phased throughout 2008 like in 2007. As expected, cash flow and working capital deteriorated significantly in the first half of 2008 due to the seasonality of our business in which we build inventory in the first half of the year to sell our products in the second half. We expect the negative cash flow in the first nine months to reverse in the final quarter of 2008, to end the year with a positive cash flow.
surf1944
16 years ago
DSM and Crucell Sign Agreement with Avid Bioservices to Serve as First Pre-Approved U.S. Contract Manufacturer of PER.C6(R) Cell Line Proteins
Wednesday June 25, 1:45 am ET
LEIDEN, Netherlands and PARSIPPANY, N.J., June 25 /PRNewswire/ -- DSM Biologics and Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) announced today that they have entered into an agreement with Avid Bioservices, Inc. of Tustin, California to join their Vendor Network. Under the terms of the agreement, Avid will be a pre-approved contract manufacturer (CMO) for licensees of the PER.C6® cell line located in the western U.S. Avid is the first U.S.-based contract manufacturer to be awarded this status.
Karen King, president of DSM Biologics notes, "We are confident that Avid's excellent reputation and service level will be instrumental in making the PER.C6® technology available to licensees on the West Coast, bringing our technology to a wider regional base as we continue to grow globally."
Steven W. King, president of Avid Bioservices added, "We are honored to achieve the distinction of being the first pre-approved U.S.-based CMO to manufacture proteins and antibodies using the PER.C6® cell line. The PER.C6® technology is recognized throughout our industry as providing important advantages compared to other platforms, including serum-free medium, scalability and high productivity levels making the system an ideal fit for Avid."
Crucell and DSM last week announced a breakthrough in the production of IgG antibodies using Crucell's PER.C6® technology. By employing the PER.C6® human cell line and DSM's proprietary XD(TM) technology, a record yield of over 27 grams per liter has been achieved.
The PER.C6® technology platform has been developed for the large-scale manufacture of biopharmaceutical products such as recombinant proteins, including monoclonal antibodies. Compared to conventional production technologies, the strengths of PER.C6® technology lie in its excellent safety profile, scalability and productivity under serum-free culture conditions.
Other terms of the agreement were not disclosed. Avid Bioservices is a wholly owned subsidiary of Peregrine Pharmaceuticals Inc. (Nasdaq: PPHM - News).
surf1944
16 years ago
Crucell Announces First Quarter 2008 Results
Tuesday May 13, 2:19 am ET
LEIDEN, NETHERLANDS--(MARKET WIRE)--May 13, 2008 --
Total revenue and other operating income of EUR 47.9 million, showing 36% growth in the first quarter of 2008 compared to EUR 35.2 million in the same period of 2007.
Net loss in the quarter halved to EUR 9.0 million compared to Q107.
New contracts awarded for Quinvaxem(TM) and strong sales in travel vaccines drive autonomous growth.
Gross margin in the first quarter improved to 40% up from 23% last year.
2008 full year guidance reiterated: total revenue and other operating income growth of 20% in constant currencies ; higher margins; positive cash flow.
Leiden, The Netherlands (May 13, 2008) - Dutch biopharma company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) today announced its financial results for the first quarter of 2008, based on International Financial Reporting Standards (IFRS). These financial results are unaudited.
Highlights:
* Supranational organizations award Crucell new contracts of $130 million for supplies of Quinvaxem(TM) in 2008 and 2009. These contracts are in addition to the December 1, 2006 announcement for the award of over $230 million for its Quinvaxem(TM) and Hepavax-Gene® vaccine, bringing the total value up to $360 million.
* Crucell's rabies monoclonal antibody cocktail entered a Phase II clinical trial in the US in March 2008. Today the start of a second Phase II study in the Philippines was announced. The start of these Phase II studies triggers the first milestone payments of a total of up to EUR 66.5 million.
* Solid growth of travel vaccines; in particular Epaxal® and Dukoral®.
* Crucell, the Aeras Global TB Vaccine Foundation and the South African Tuberculosis Vaccine Initiative (SATVI) present encouraging preliminary results from the Phase I Ad35 tuberculosis vaccine study, showing that CD8 immune responses are considerably higher than ever seen in a tuberculosis vaccine study.
* Senior management outlines a compelling case for investment during an analysts meeting in London, based on significant growth of the vaccines business, progress of its pipeline and its unique technologies. A clear focus on achieving operational excellence is showcased as an integral part of Crucell's strategy for accelerating growth, targeting a cost saving of 15% (excluding R&D) by the end of 2009.
* DSM and Crucell reached a record production level of 15 g/L for an antibody product, another important milestone for the PER.C6® production technology.
* Crucell enters into an exclusive vaccine development agreement with Wyeth Pharmaceuticals. Crucell is responsible for the development and manufacturing of certain components of a vaccine and Wyeth for the clinical development. The development is taking place in Crucell's facility in Bern (Switzerland), which had been fully impaired in 2006, now enabling a partial reversal of EUR 5.2 million of that impairment.
* Crucell and DSM Biologics announce that MorphoSys AG has decided to extend the PER.C6® technology licensing agreement, exercising an option for clinical and commercial production of antibodies.
Financial Highlights:
http://biz.yahoo.com/iw/080513/0396394.html
surf1944
16 years ago
Aeras, Crucell and South African Tuberculosis Vaccine Initiative Announce Encouraging Preliminary Results of Tuberculosis Vaccine Clinical Trial in South Africa
ATLANTA, April 9, 2008 /PRNewswire-USNewswire/ -- Dutch biotechnology company Crucell N.V., the Aeras Global TB Vaccine Foundation and the South African Tuberculosis Vaccine Initiative (SATVI) present a progress update and immunology data from a Phase I Ad35 tuberculosis vaccine study at the biennial 'Tuberculosis Vaccines for the World' conference (Atlanta, Georgia, April 9 to 11) today. The study, conducted in Worcester, South Africa and launched in May 2007, is the second phase I study in a current series of three and has revealed promising results.
Highest CD8 immune responses ever in a TB vaccine study
Preliminary data show both critical arms of the cellular immune system, CD4 and CD8 immune T-cells were induced and that in those participants who responded, CD8 immune responses are considerably higher than has ever previously been seen in a TB vaccine study.
The trial of AERAS-402/Crucell Ad35, which began in May 2007, is being conducted as a double-blind, randomized, placebo-controlled dose escalation study in four groups of healthy adults vaccinated at birth with BCG (Bacille Calmette-Guerin) vaccine. A total of 40 healthy adult volunteers are enrolled.
'While preliminary, these results are promising. We are pleased that Crucell's technologies are playing a key role in the search and development of a much-needed TB vaccine,' said Dr. Jaap Goudsmit, Chief Scientific Officer at Crucell. 'We highly value the collaboration with Aeras and SATVI on this important mission.'
Third key clinical phase I study in progress
Aeras and Crucell began jointly developing this vaccine candidate in 2004 using Crucell's AdVac(R) vaccine technology and PER.C6(R) manufacturing technology. A first Phase I clinical trial launched in October 2006 in Kansas, USA indicated that the vaccine candidate is safe in healthy adults in the US. The results of a second study, launched in May 2007, are presented in Atlanta at the 'TB Vaccines for the World' conference. A third phase I study in healthy adults in St. Louis, Missouri, USA was launched in December 2007 and 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.
'The world urgently needs a new TB vaccine, and although we are still in the early stages of clinical trials, the preliminary data of this second phase I study are promising,' said Dr. Jerald C. Sadoff, President and CEO of Aeras. 'Aeras is delighted to be working with the excellent researchers at Crucell and SATVI. We are grateful to the Bill & Melinda Gates Foundation, the Netherlands Ministry of Foreign Affairs, and our other donors for their financial support of this trial and our vaccine development efforts.'
This trial was conducted in the Boland-Overberg region of Western Cape Province in South Africa, which has one of the world's highest TB burdens.
'SATVI is proud to be playing such an important role in the global effort to develop new vaccines to combat TB, which are needed in South Africa and worldwide,' said Dr. Gregory Hussey, Director of SATVI and Principal Investigator for the trial. 'By conducting this trial, we have advanced the development of a new TB vaccine, expanded scientific capacity, and built awareness of the need for new TB vaccines.'
surf1944
16 years ago
Crucell Announces First in Man Study with New Adenovirus Vector
Thursday April 3, 8:06 am ET
Recombinant adenovirus 26 vector avoids pre-existing immunity and is used in new HIV vaccine
LEIDEN, NETHERLANDS--(MARKET WIRE)--Apr 3, 2008 -- Recombinant adenovirus 26 vector avoids pre-existing immunity and is used in new HIV vaccine
Leiden, The Netherlands, 3 April 2008 - Dutch biotechnology company Crucell N.V. today announced that the novel recombinant adenovirus serotype 26 (rAd26) vector, which is jointly developed by Crucell and the Beth Israel Deaconess Medical Center (BIDMC), will be used in a phase I clinical study to test a new HIV vaccine. The rAd26 vector is specifically designed to avoid the pre-existing immunity to the more commonly used adenovirus serotype 5 (Ad5), which has recently shown limitations as an HIV vaccine vector.
The rAd26 vaccine is the first HIV vaccine candidate that emerges from the Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program, which brings together researchers from academia and industry in an effort to accelerate the development of promising HIV/AIDS vaccines. Crucell, Harvard Medical School (HMS) and the BIDMC participate in this program, which is sponsored by the National Institutes of Health (NIH).
The phase I clinical study will be conducted at the Brigham and Women's Hospital (BWH) in Boston and will focus on assessing the safety and immunogenicity of the vaccine. The study will involve 48 healthy volunteers.
"The rAd26 vaccine vector has been selected for its particularly low seroprevalence in humans and for its potential immunogenicity and protective efficacy as was shown in preclinical studies", says Dan H. Barouch, MD, PhD, Associate Professor of Medicine at BIDMC and HMS and Principal Investigator in the IPCAVD program.
Jaap Goudsmit, Chief Scientific Officer at Crucell: "The rAd26 vector, as part of our AdVac® technology program, is designed to overcome the problem of pre-existing immunity in humans against the most commonly used recombinant vaccine vector, adenovirus serotype 5."
Antibodies to Ad5, a common cold virus, are widespread among people of all ages and are known to lower the immune response to Ad5-based vaccines, thereby impairing the efficacy of these vaccines.
"The rAd26 vector does not regularly occur in the human population and antibodies to this vector are rare. The rAd26 vector therefore is efficacious in eliciting good T and B cell responses", Goudsmit continues. "We are excited about the first in man study of this newly developed vector, that could provide a solution to the issues that raised from previous HIV vaccine trials."
About PER.C6® technology
Crucell's PER.C6® technology is a cell line developed for the large-scale manufacture of biopharmaceutical products including vaccines. The production scale potential of the PER.C6® cell line has been demonstrated in an unprecedented successful bioreactor run of 20,000 litres. Compared to conventional production technologies, the strengths of the PER.C6® technology lie in its excellent safety profile, scalability and productivity under serum-free culture conditions. These characteristics, combined with its ability to support the growth of both human and animal viruses, make the PER.C6® technology the biopharmaceutical production technology of choice for Crucell's current and potential pharmaceutical and biotechnology partners.
surf1944
16 years ago
Crucell Announces Start of Phase II Clinical Study Rabies Monoclonal Antibody Combination in US
Monday March 31, 8:27 am ET
First Milestone Achieved in Collaboration Agreement with Sanofi Pasteur
LEIDEN, NETHERLANDS--(MARKET WIRE)--Mar 31, 2008 -- First Milestone Achieved in Collaboration Agreement with Sanofi Pasteur
Leiden, The Netherlands, 31 March 2008 - Dutch biotechnology company Crucell N.V. today announced that its rabies monoclonal antibody combination has entered a Phase II clinical trial in the United States. At the beginning of the year, Crucell announced it had signed a collaboration and commercialization agreement with sanofi pasteur, the vaccines division of sanofi-aventis Group, for Crucell's rabies monoclonal antibodies to be used in combination with sanofi pasteur rabies vaccine for post-exposure prophylaxis against this fatal disease. The start of the Phase II study constitutes the first milestone in this agreement.
The clinical trial will be a randomized, single-blind, controlled study in 140 healthy volunteers that will test the antibody product in association with sanofi pasteur rabies vaccine and compare it to the currently marketed human rabies immune globulin or placebo, in association with rabies vaccine. The main parameters under investigation will be safety, tolerability and (rabies virus) neutralizing activity.
"We are very pleased with our continued and rapid progress with this next generation rabies treatment," said Ronald Brus, Crucell's Chief Executive Officer. "The swift development of this rabies monoclonal antibody product would be extremely valuable in reducing the global burden of this fatal disease."
Sanofi Pasteur is the worldwide market leader in providing biologicals for pre- and post-exposure prophylaxis against rabies. In the last 20 years, over 20 million people in 100 countries have been treated with sanofi pasteur's rabies products.
About rabies
Rabies is a viral disease of mammals most often transmitted through the bite of a rabid animal. The virus infects the central nervous system, causing encephalitis (inflammation of the brain) and ultimately death if medical intervention is not sought promptly after exposure. There is no proven treatment for rabies once symptoms of this fatal disease have appeared. Rabies is prevented by post-exposure prophylaxis (PEP) with the combined administration of a rabies vaccine and rabies immunoglobulin (RIG). Rabies is prevalent in Europe, Asia, Africa, North America and South America. Every year approximately 10 million people are vaccinated against the disease worldwide. An estimated 40,000 to 70,000 people die from rabies each year, mainly in Asia.
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mkinhaw
14 years ago
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