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Crucell Announces Second Quarter 2008 Results

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  1. [verwijderd] 12 augustus 2008 08:40
    Total revenue and other operating income increased by 51% to €59.6 million, compared to €39.4 million in the second quarter of 2007.
    Solid gross margins of 36% and significantly reduced net loss for the second quarter to €7.9 million compared to €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 €30 million by the end of 2009.
    Initial net cost savings of €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 €59.6 million compared to €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 €7.9 million versus a net loss of €18.2 million in the same quarter of 2007.
    Cash and cash equivalents at the end of the second quarter amounted to €106.9 million versus €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 €18.0 million compared to net cash used in operating activities of €10.2 million in the same quarter of 2007.

    Key Figures Q2 2008:
    (€ million, except net loss per share)
    Second Quarter
    Six months ended June 30
    2008
    2007
    Change
    2008
    2007
    Change

    59.6 39.4 51%
    Total revenues and
    other operating
    income 107.5 74.6 44%
    (7.9) (18.2) (57%)

    Net loss (16.9) (36.7) (54%)
    (0.12) (0.28) Net loss per share
    (basic and diluted) (0.26) (0.57)
    Cash & cash equiv.:
    - June 30, 2008
    - Dec 31, 2007
    106.9
    163.2



    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 €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."
  2. [verwijderd] 12 augustus 2008 08:41
    Product and Business Update:

    Product Update
    Product sales for the second quarter of 2008 amounted to €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 €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 s
  3. [verwijderd] 12 augustus 2008 08:43
    En in het NL, bij elkaar in 1 draadje .............

    AMSTERDAM (Dow Jones)--Crucell nv heeft over het tweede kwartaal van 2008 een lager dan verwacht nettoverlies geboekt, bij een fors hoger dan verwachte omzet. Dat maakt het Leidse biotechbedrijf dinsdag bekend.

    Crucell zegt goed op stoom te zijn met zijn kostenbesparingsprogramma en herhaalt zijn financiele doelstellingen voor 2008.

    Het nettoverlies kwam uit op EUR7,9 miljoen, tegen EUR18,2 miljoen in het tweede kwartaal van 2007, terwijl de omzet met 51% steeg naar EUR59,6 miljoen.

    Drie analisten geraadpleegd door Dow Jones Nieuwsdienst rekenden gemiddeld op een nettoverlies van EUR12 miljoen, bij een omzet van EUR51,7 miljoen.

    De omzetgroei was te danken aan sterke verkopen van kindervaccins, met name Quinvaxem, betere verkoop van vaccins tegen reisziekten en hogere inkomsten uit licenties.

    Crucell zegt "op stoom" te zijn met het kostenbesparingsprogramma, waarmee het bedrijf voor het einde van 2009 EUR30 miljoen aan kosten wil besparen. In de tweede helft van 2008 zullen de besparingen naar verwachting uitkomen op EUR3 miljoen.

    Het Leidse biotechbedrijf herhaalt de verwachting, dat in 2008 de omzet zal groeien met 20% bij constante valuta, met hogere marges dan het voorgaande jaar en een positieve kasstroom.

    Het aandeel Cruceel sloot maandag op EUR12,06.
  4. [verwijderd] 12 augustus 2008 08:53
    quote:

    oudje schreef:

    Goed gedaan Robertix, jij begrijpt er iets van.
    Anders krijg je weer 6 draadjes met verspreidingen(is dat een woord?)........

    1e Rabiesstudie afgerond : resultaten in Oktober.

    Dit laatste speciaal voor grootoorvleermuis.
  5. wilb52 12 augustus 2008 08:58
    Brus kan het weer niet laten

    Bij goed Q3 , mogelijk opwaartse bijstelling doelen.

    Dat wordt weer een hoog you know gehalte
  6. [verwijderd] 12 augustus 2008 09:37
    quote:

    Cybertom schreef:

    Ach Willy, jij kunt het toch ook weer niet laten...
    Ach ja, bij het vorige kwartaal zat iedereen te vragen om een bijstelling.

    Nu uit Brus zich heel voorzichtig en dan is het nog niet goed.
  7. wilb52 12 augustus 2008 09:42
    quote:

    oudje schreef:

    [quote=Cybertom]
    Ach Willy, jij kunt het toch ook weer niet laten...
    [/quote]

    Ach ja, bij het vorige kwartaal zat iedereen te vragen om een bijstelling.

    Nu uit Brus zich heel voorzichtig en dan is het nog niet goed.
    Nee, oudje.
    Brus moet gewoon zijn kaken op elkaar houden.
    Dit is nu precies wat hij al jaren gedaan heeft.
    En de markt heeft dat in retrospect niet bepaald gewaardeerd, omdat het niet werd waargemaakt.
    Geef mij Cees dan maar.
  8. [verwijderd] 12 augustus 2008 09:50
    Ik blijf zeggen dat Brus zich voorzichtig uitlaat.

    Jij blijft je erg met Brus bezighouden in negatieve zin. Maar deze keer is het een flink pak spijkers op laag water.
  9. [verwijderd] 12 augustus 2008 09:52
    als je door een roze bril kijkt en ze in kwartaal 3 en 4 40% omzetgroei realiseren en 5% koersverlies, maken ze bijna 300 mln omzet in 2008. Ik begrijp ook wel dat Brus zegt dat er een opwaardering van de verwachtingen aan zit te komen. Dat moeten dicht bij het vuur allang kunnen inschatten. Ze zullen het ook nogs een moeten produceren al die groei, dat doe je niet in 1 dag.

    Dus reken er maar op dat die opwaardering er komt. Dollar is nog maar 7% van de 1,38 die Crucell heeft genomen als middenkoers.

    Beetje slap verhaal van Petercam dat de marges tegenvallen.
  10. wilb52 12 augustus 2008 09:56
    Nee, oudje , ik hou me helemaal niet met Brus bezig , en zoek geen spijkers.
    deze proefbalonnetjes , kan hij maar beter niet oplaten , zelfs al zou hij het zeker weten.
    Dat is nl de historie en die heeft telkenmale weer geen positieve invloed gehad op het aandeel.
    En aangezien ik nogal wat aandelen heb ( > 1 ) , ben ik van mening:

    Zwijgen is goud
  11. [verwijderd] 12 augustus 2008 09:59
    Bij de omzetstijgingen van het eerste en tweede kwartaal is het onmogelijk om niets te zeggen.
    Dan begrijpt niemand er meer wat van.

    Daarom blijf ik van mening: hij uit zich zeer voorzichtig. Hij zegt nog steeds niet, dat het zo zal zijn.
  12. forum rang 9 josti5 12 augustus 2008 10:00
    quote:

    wilb52 schreef:

    Nee, oudje , ik hou me helemaal niet met Brus bezig , en zoek geen spijkers.
    deze proefbalonnetjes , kan hij maar beter niet oplaten , zelfs al zou hij het zeker weten.
    Dat is nl de historie en die heeft telkenmale weer geen positieve invloed gehad op het aandeel.
    En aangezien ik nogal wat aandelen heb ( > 1 ) , ben ik van mening:

    Zwijgen is goud
    Tsja, en daar denkt wijma weer heeeel anders over: 'outlook valt tegen'...

    Zoveel mensen, zoveel zinnen, wilb.

    Alleen zegt Wijma het 1x, en jij tig keer.
  13. forum rang 4 Sir Piet 12 augustus 2008 10:01
    Dat vind ik een mooie opmerking. "zwijgen is goud". Dat zou voor meer mensen kunnen gelden, incl. analisten. By the way, erg mooie cijfers.
  14. mcking 12 augustus 2008 10:02
    niet zozeer zwijgen is goud danwel conservatief zijn in de prognoses en de concensus gewoon elk kwartaal verslaan.
    kijk maar hoe ze dat in Amerika doen.

    Brus moet geen verwachtingen uitspreken die ze niet waar kunnen maken, dus eens met sammy
  15. forum rang 4 aossa 12 augustus 2008 10:06
    quote:

    mcking schreef:

    Brus moet geen verwachtingen uitspreken die ze niet waar kunnen maken ...
    Maar misschien kan hij ze wel waar maken, who knows !
  16. [verwijderd] 12 augustus 2008 10:09
    quote:

    mcking schreef:

    niet zozeer zwijgen is goud danwel conservatief zijn in de prognoses en de concensus gewoon elk kwartaal verslaan.
    kijk maar hoe ze dat in Amerika doen.

    Brus moet geen verwachtingen uitspreken die ze niet waar kunnen maken, dus eens met sammy
    Hoe ze dat in Amerika doen?????

    Elk procentje afwijking in de toekomstverwachting wordt direct gerapporteerd!!!
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