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Aandeel Biocartis BRU:BCART.BL, BE0974281132

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  1. ElTorro 22 september 2021 16:48
    Hi FL, police investigation excluded malicious intent. How they came to this conclusion I don't know. The insurance company will also look into detail before starting to pay off the damage.
    We are awaiting feedback from management on the fire impact, ML2, US approvals, etc..
    Maybe I should go to Mechelen and go see for myself what's going on :-)
  2. Flatlander 23 september 2021 00:21
    quote:

    ElTorro schreef op 22 september 2021 16:48:

    Hi FL, police investigation excluded malicious intent. How they came to this conclusion I don't know. The insurance company will also look into detail before starting to pay off the damage.
    We are awaiting feedback from management on the fire impact, ML2, US approvals, etc..
    Maybe I should go to Mechelen and go see for myself what's going on :-)
    Hi El Torro,

    I recall hearing the same but thought something more might be released. I'm uncertain how you can exclude malicious intent without identifying the source of the fire.

    Regards FL
  3. forum rang 10 voda 23 september 2021 07:30
    PERSBERICHT: Persbericht Biocartis Group NV: Biocartis kondigt heropstart aan van haar hoge-volume cartridge productielijn
    PERSBERICHT: 23 september 2021, 07:00 CEST

    Biocartis kondigt heropstart aan van haar hoge-volume cartridge productielijn

    Mechelen, België, 23 september 2021 -- Biocartis Group NV (de 'Vennootschap' of 'Biocartis'), een innovatief bedrijf in de moleculaire diagnostiek (Euronext Brussels: BCART), kondigt vandaag de heropstart van haar hoge-volume cartridge productielijn 'ML2' aan.

    Na een bra www.globenewswire.com/Tracker?data=_H... n www.globenewswire.com/Tracker?data=p6... d www.globenewswire.com/Tracker?data=SX... die uitbrak in een van de opslagfaciliteiten van het bedrijf in Mechelen (België) in de nacht van 30 juli 2021, werd de productie van de ML2-lijn tijdelijk opgeschort omdat structurele herstellingen aan het gebouw en bepaalde ondersteunende systemen nodig waren. Deze herstellingen, alsook verschillende daaropvolgende controle- en kwaliteitsgerelateerde procedures, werden eerder deze week voltooid. Dit leidde tot de succesvolle herstart van de ML2-lijn in de nacht van 21 september 2021.

    Herman Verrelst, Chief Executive Officer van Biocartis, reageerde: "Ik ben zeer verheugd te kunnen aankondigen dat vanaf vandaag de commerciële productie van cartridges op de ML2-lijn is hervat. Onze teams hebben enorm hard gewerkt om de ML2-lijn weer operationeel te krijgen na het brandincident. We kunnen trots zijn op deze prestatie die de sterkte en veerkracht van onze teams laat zien."

    Eerder deze maand, op 2 september 2021 bij de aankondiging van haar H1 2021 resultaten, had Biocartis haar 40% cartridgevolume groeidoelstelling voor 2021 bevestigd, echter onder voorbehoud van de herstart van de ML2-lijn en de tijdige beschikbaarheid van reagentia grondstoffen voor Idylla(TM) cartridges in voldoende hoeveelheden. Nu de ML2-lijn opnieuw is opgestart, blijft de Vennootschap inspanningen leveren om de levering van bepaalde test-specifieke reagentia veilig te stellen, om de volledige capaciteit van de ML2-lijn te kunnen benutten en om de potentiële tijdelijke onbeschikbaarheid van bepaalde Idylla(TM) producten te minimaliseren.

    ----- EINDE ----

    Meer informatie:

    Renate Degrave

    Hoofd Corporate Communications & Investor Relations Biocartis

    e-mail rdegrave@biocartis.comhttps://www.globenewswire.com/Tracker?data=DZPciWeI2qAp-Bcdot2VyKIibeMN3tTuyE8IvasHxzM-cI2BLHEtgsuXa-O7GcHXb0GAOWamk5aGUKIHCa3o2rZ9ofliACghIlBIE7C9i7o=

    tel +32 15 631 729

    gsm +32 471 53 60 64
  4. forum rang 10 voda 23 september 2021 10:17
    'Prognose Biocartis is redelijk'

    Analist Thomas Vranken reageert op het nieuws van de diagnosticaspeler Biocartis dat het de ML2-productielijn weer heeft herstart (zie post 7u21). 'De herstart bevestigt dat de apparatuur geen kritische schade heeft opgelopen. Maar we hadden ook niet verwacht dat een disfunctionele productielijn de grootste flessenhals was voor het bedrijf op de korte termijn.'

    'Want de brand heeft vooral een ravage aangericht bij de voorraad reagentia', vervolgt de analist. 'Die zijn vermoedelijk een stuk moeilijker om te vervangen. Want de wereldwijde tekorten van testmaterialen zal door de pandemie waarschijnlijk voortduren in de komende maanden.'

    Maar Vranken denkt dat de prognose van het bedrijf - 40 procent groei in cartridgevolumes voor 2021 - redelijk is. 'Dat cijfer ligt binnen de marges van de mogelijkheden, gegeven de indrukwekkende expansie van 96 procent in de eerste jaarhelft, wanneer de reagentia tijdelijk geleverd worden.'

    De analist blijft bij zijn koopadvies en koersdoel van 7 euro. Het aandeel wint 2,8 procent.

    www.tijd.be/markten-live/live-blog/po...
  5. forum rang 10 voda 23 september 2021 10:40
    Advies van KBC Securities over Biocartis
    Beurshuis KBC Securities
    Aandeel Biocartis Group
    Datum 23 september 2021
    Advies Kopen
    Koersdoel 7,00 EUR

    Detail advies
    BRUSSEL (Trivano.com) - Op 23 september 2021 hebben de analisten van KBC Securities hun beleggingsadvies voor Biocartis Group (BCART; ISIN: BE0974281132) herhaald. Het advies van KBC Securities voor Biocartis Group blijft "kopen".

    De analisten behouden hun koersdoel van 7,00 EUR.

    Op 25 februari 2021 publiceerde Biocartis Group zijn jaarresultaten.
  6. Stockbrood 23 september 2021 19:40
    quote:

    ElTorro schreef op 23 september 2021 16:53:

    It was a close call by they succeeded in getting the ML2 operational again.
    I hope management realizes there is no longer margin for errors.
    Don't over react. Let's be honest... They didn't want the fire as well. Let's give them some credit. I don't think anyone of us would have done differently. They communicated the fire and theirplanned action as well as a timing. They fulfilled Al the promises they made.

    They should get kudo's for the way they communicated and acted on the fire incident .
  7. Flatlander 23 september 2021 21:17
    quote:

    Stockbrood schreef op 23 september 2021 19:40:

    [...]

    Don't over react. Let's be honest... They didn't want the fire as well. Let's give them some credit. I don't think anyone of us would have done differently. They communicated the fire and theirplanned action as well as a timing. They fulfilled Al the promises they made.

    They should get kudo's for the way they communicated and acted on the fire incident .
    Stockbrood

    While I'm glad they have re-established ML-2 operations, it remains to be seen whether it is constrained in any way by the stock of reagents they were able to assemble. Potential exists that some assays may still be affected by different suppliers etc. We'll have to wait for additional updates.

    I've resigned my self that my 2022 decision time frame is likely to be impeded by the fire. The 2nd half 2021 will not be representative of gross margins since ML2 was off line. That means we will not get a real data point for almost a year.

    Regards
    FL
  8. ElTorro 24 september 2021 09:15
    Hi Stockbrood.
    Of course I'm not talking about the fire, they handled this one very well, and you can see the market appreciating this. Trust, it’s all about trust. In the course off recent years it seems they have lost this little by little, due to certain decisions they made and the way of communicating.
    What I’m saying is that they have to see this point as a fresh start to build out a positive story and making sure that the point of profit is within the near future (as promised 2 years ago). And in this story the margin for error is very small now. Because as you know, trust comes on foot, but leaves on horseback.
  9. Stockbrood 24 september 2021 19:40
    quote:

    ElTorro schreef op 24 september 2021 09:15:

    Hi Stockbrood.
    Of course I'm not talking about the fire, they handled this one very well, and you can see the market appreciating this. Trust, it’s all about trust. In the course off recent years it seems they have lost this little by little, due to certain decisions they made and the way of communicating.
    What I’m saying is that they have to see this point as a fresh start to build out a positive story and making sure that the point of profit is within the near future (as promised 2 years ago). And in this story the margin for error is very small now. Because as you know, trust comes on foot, but leaves on horseback.
    I agree.
    Let the acceleration begin :)
  10. OzDx 3 oktober 2021 12:24
    Check out this new article discussing use of Idylla titled, Frequency of microsatellite instability (MSI) in upper tract urothelial carcinoma: comparison of the Bethesda panel and the Idylla MSI assay in a consecutively collected, multi-institutional cohort.

    Highlight this bit in discussion section.

    "In this investigation, with the Idylla MSI Assay, a new, innovative easy to use and time-saving approach for MSI diagnostics was tested for UTUCs. To date, the newly designed marker set, consisting of seven mononucleotides, is clinically validated and applied for diagnostic use for colorectal cancer and is ongoing for verification of endometrial carcinoma.32 In our study of 243 UTUCs, we observed a high concordance of 98.35% of MSI testing between the two methods. These concordance rates are comparable with those of colorectal cancer. Compared with standard diagnostics, we propose that the Idylla MSI Assay is a more robust methodology with a lower invalid rate. Nine vs five invalid results were detected using standard method compared with the Idylla MSI Assay, respectively. Additional reasons for implementing the Idylla MSI Assay into routine laboratory testing are: (1) the turnaround time was shortened significantly to approximately 3?hours compared with a workload of 2?days using the NCI method and (2) implementing a fully automated analysis system as well as a reduction of preanalytical steps also significantly reduces human resources. Therefore, our study could determine that the same marker panel, applied for colorectal cancer samples, is transferable to UTUC with a high concordance to current established testing methods."
  11. Flatlander 3 oktober 2021 20:55
    Oz

    Thanks for posting the info. UTUCs are fairly rare and I'm not sure if shaving a couple days off of the results TAT has significant impact on the treatment and/or the prognosis. But as you posted, the ability to recover actionable results in cases where the immunohistochemistry failed to yield results should be very relative as is the fact that Idylla requires significantly less tachnician time and effort.

    I consider Promega the primary MSI competitor since they are aligned with Merk as a CDx for Keytruda, Their 510K review looks like it took about 8 months, so hopefully BCART has a positive determination by years end.
    www.accessdata.fda.gov/cdrh_docs/pdf2...

    FL


    www.accessdata.fda.gov/cdrh_docs/pdf2...
  12. Flatlander 7 oktober 2021 06:23
    Besides the weakness in the overall markets we are still dealing with the glass half full scenario that Biocartis has presented us for the past few years. On one hand I can identify several macro conditions that should represent a substantial tailwind:

    1) Pent up MDx backlog from all the proceedures and oncology testing that were delayed due to pandemic concerns;

    2) The Idylla social distancing and testing on demand testing advantages as the market emerges from the pandemic;

    3) It looks like global growth is slowing at the same time commomdity and labor costs are increasing. This could lead to stagflation. Idylla is well situated for labs seeking to constrain costs to maintain margins since the system requires minimal operator/technician time; and

    4) Studies have indicated a trend toward decentralization of MDx testing (moving closer to patient and point of care).

    On the other hand the we have familiar concerns that have dogged the shareprice for years:

    1) lengthy timeframes for registration approvals outside of the EU;
    2) Cost structure and bloat that hinder margin improvement and a move towards profitability;
    3) Execution/communication breakdowns (fire, handling of GHDX collaboration dissolution etc);
    4) Dwindling cash and convertible debt.

    I could go on and on for both lists. The point is that the Oncology MDx market is fragmented and no one firm controls dominant market share, The MDx market is growing at an estimated 20%/year rate. I see no reason why automation will not carve out a niche in this sector. Factors have aligned to provide BCART a tailwind. The question remains whether BCART can step up its execution to take advantage of these factors and compete. I was hoping that BCART could put together a good financial report before going into the next cash raise. Unfortunately, we will get few good data points to assess performance in the next year. I still think they should list in the US but the overall market is becoming less favorable.

    meticulousblog.org/top-10-companies-i...

    FL
  13. ElTorro 7 oktober 2021 09:31
    Thx for your ever constructive input FL.
    I guess for the moment no news is good news, next point to assess the stock is 10 November.
    As you stated the macro conditions are becoming more and more unfavorable for startup investment shares so it seems. There are a lot of macro factors that could go right or wrong these days.
    BCART was unable to profit from the bull market the past years (pre- and post corona of course), due to some events you mentioned.
    Some events in the (near) future (US approvals for one) could turn it the other way and push the share towards safer grounds. So I’m still positive for the moment.
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