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  1. Flatlander 1 maart 2020 15:56
    Gijpie

    A lot of take aways.
    1) The cancer genetics part of MDx market is growing at the fastest rate in the segment;
    2) Care is shifting to the point of care environment;
    3) FDA and Insurers are likely to push for consistency at some point and not the current patchwork of lab developed tests (LDTs). But this is unlikely to happen under the Trump administration;
    4) The insurer reimbursement rates in the US are about 100% greater than the old Fisher list prices for various Idylla assays. There is room to either raise prices in the future or allow significant profit margins for POC providers;
    5)Cepheid looks like a good analog. It has grown market share over a decade and is now #2 in the infectious disease MDx space;
    6)Looks like NGS providers are at a breaking point. Their push back has resulted in constant reimbursement pricing the past couple years.

    There are probably other key points that i'm missing
    Regards
    FL

  2. Squeeze 1 maart 2020 19:16

    3,001 Coronavirus deaths this year

    80,906 Seasonal flu deaths this year

    Every year an estimated 290,000 to 650,000 people die in the world due to complications from seasonal influenza (flu) viruses.
    This figure corresponds to 795 to 1,781 deaths per day due to the seasonal flu.

    www.worldometers.info/



  3. Squeeze 2 maart 2020 11:24
    quote:

    brightlight schreef op 12 januari 2020 13:40:



    Het is hier allemaal al gezegd op dit forum, maar ik heb hier de aankomende 2020 newsflow nog even op een rijtje gezet. Indrukwekkend wat er allemaal staat aan te komen!
    • 16/01 JP Morgan Health Conference; wat gaat Biocartis daar vertellen en trekt dat verhaal nieuwe investeerders aan? Valt er nieuws te rapen?
    • 5/03 Jaarresultaten: aankondiging van de verwachtingen voor 2020; ik verwacht een conservatieve outlook maar zelfs dan is een positieve verrassing niet uitgesloten
    • 23/04 Q1 2020 Business Update
    • 8/05 Jaarlijkse Algemene Aandeelhoudersvergadering Biocartis Group NV
    • Zomer 2020 Capital Markets Day voor financiële analisten, media & institutionele investeerders
    • 3/09 H1 2020 resultaten
    • 12/11 Q3 2020 Business Update


    Onbepaald qua timing:
    1. 510k FDA beslissing (approval?) m.b.t. ctEGFR Mutation Assay
    2. 510k FDA beslissing (approval?) m.b.t. NRAS BRAF EGFR S492R Mutation Assay
    3. 510k FDA beslissing (approval?) m.b.t. ctBRAF Mutation Assay
    4. 510k FDA beslissing (approval?) m.b.t. ctKRAS Mutation Assay
    5. 510k FDA beslissing (approval?) m.b.t. ctNRAS BRAF EGFR S492R Mutation Assay
    6. 510k FDA beslissing (approval?) m.b.t. SeptiCyte RAPID
    7. CE-Mark beslissing (approval?) m.b.t. SeptiCyte RAPID
    8. 510k FDA beslissing (approval?) m.b.t. Oncotype DXx IVD Breast Recurrence Score Test
    9. CE-Mark beslissing (approval?) m.b.t. Oncotype DXx IVD Breast Recurrence Score Test
    10. Oncotype DX Prostate Proof of Concept completion (is me niet duidelijk hoe dit past in het 510k goedkeuringsproces – wie weet meer?)
    11. beslissing (approval?) m.b.t. CDx Test (is me niet duidelijk of deze in de US of EU wordt aangevraagd, of beide – wie weet meer?)

    12. nieuws over de beslissingen (approvals?) m.b.t. de Bcart testen in Japan (is me niet duidelijk voor welke testen Bcart (Nichirei Bioscience) goedkeuring gaat vragen in Japan – wie weet meer?)

    13. nieuws over de voortgang m.b.t. de betreding van de Chinese markt (Wonfu)

    14. ook worden mogelijk in 2020 nieuwe partnerships voor Assay of Test ontwikkeling aangekondigd.

    Ben ik nog iets vergeten?

    De Kite Test en de MSI Test zijn waarschijnlijk voor 2021.

    Met de massa potentiële approvals die op stapel staan zou het best wel eens een zeer interessant jaar kunnen worden. Het is moeilijk het belang van deze approvals te overschatten. De 510k approvals openen de deur naar de grootste MDx markt ter wereld (de US vertegenwoordigt 43% van de wereldmarkt!). Nu staat die deur nog maar op een kier. Bovendien zou 2020 wel eens de goedkeuring kunnen brengen van de door Flatlander zo verwachte en gehoopte Killer-App (OncoDX Breast of Septicyte Rapid).
    Voor een kapitaalverhoging hoeven we de volgende 1.5 a 2 jaar niet te vrezen, ook een belangrijk gegeven! Negatieve verrassingen zijn uiteraard altijd mogelijk, maar gezien de lage startpositie van de Bcart beurskoers zie ik heel wat opwaarts potentieel dit jaar. Management heeft bovendien lessen getrokken uit de fouten van het verleden. Het zou best wel eens kunnen dat we deze lage koersen nooit meer terug zien. Fingers crossed! Dit is uiteraard een persoonlijke mening. Ieder denkt er het zijne van.
    BL



    Reminder from Brightlight


  4. Flatlander 2 maart 2020 13:53
    quote:

    Gijpie schreef op 2 maart 2020 12:35:


    Immunexpress Achieves ISO 13485:2016 & EN ISO 13485:2016 Quality Certification for Worldwide Commercialization of SeptiCyte® RAPID
    (PRNewsfoto/Immunexpress, Inc.) Flat , can’t figure this one out , is it about the sepsis test that runs on Idylla


    Gijpie

    I don't have a manufacturing background so I welcome someone who does to educate us on the significance. From what I see it is essentially completion of quality control certification process. The certification seems widely accepted throughout the world but from what I can see it appears that EU marking is not dependent on the ISO certification. In some cases it looks like products from other manufacturers appear to have been EU marked before ISO certification. In other cases it occurs after the certification.

    It is unique to Septicyte and I believe the cert required some/extensive involvement on BCARTS part. I believe it indicates ImmunExpresses intent to rollout worldwide ASAP.

    FL
  5. Rarezot 2 maart 2020 14:22
    quote:

    Flatlander schreef op 2 maart 2020 13:53:


    [...]

    Gijpie

    I don't have a manufacturing background so I welcome someone who does to educate us on the significance. From what I see it is essentially completion of quality control certification process. The certification seems widely accepted throughout the world but from what I can see it appears that EU marking is not dependent on the ISO certification. In some cases it looks like products from other manufacturers appear to have been EU marked before ISO certification. In other cases it occurs after the certification.

    It is unique to Septicyte and I believe the cert required some/extensive involvement on BCARTS part. I believe it indicates ImmunExpresses intent to rollout worldwide ASAP.

    FL


    Gijpie, FL,

    ISO 13485 is basically about a quality management system. It's a system that proves traceability. I don't think Biocartis was heavily involved in it, since it is their responsibility to track everything they supply. Once supplied to ImmuneExpress it is the resposibility of ImmuneExpress to track their products. So maybe Biocartis changed some product-codes to make it easier for ImmuneExpress to implement it in their management system, but that will be about it...

    This also explains why the CE-certification isn't connected with this. CE is about the product, ISO13485 is about traceability. The ISO13485 is needed to supply medical equipment (it is an international standard). CE is needed to prove that the product itself is up to european standard.

    More info for this ISO-norm can be found here: www.iso.org/standard/59752.html

    Rarezot
  6. lextamindose 2 maart 2020 14:24
    Had niet verwacht dat de koers terug zou terugvallen onder de 5 maar had voor de zekerheid toch een order geplaatst op 4,9 en dus toch aardig bijgekocht. Nog 3 dagen en we dan zullen we wel weten of dit verstandig was.

    Ik had een maand geleden novavax aangekocht en dat aandeel heeft me geen windeieren gelegd.
  7. Flatlander 2 maart 2020 14:42
    I'd like to comment on points 9-11, in the interest of getting the facts straight.

    #9) I don't believe that GHDX has ever mentioned the intent to roll out OncoTypeDx Breast in the US. At present we should assume that this will remain a lab based test. However, Keven Conroy and the rest of the EXAS exects are under pressure to cut costs and realize synergies of the merger, so I would not be surprised if they announce the intent to close the lab and roll out on Idylla if the EU rollout is successful.

    #10)OncoType Dx proof of concept is the earliest stage of development. Essentially proving that the lab assay is amenable to being run on Idylla. Given the December 2018 announcement of that the partnership has been extended to this assay, I think there is a good chance that this proof has been completed but no announcement was made. Again there are competitors, so GHDX and BCART may be deciding to remain silent on this timing.

    #11)GHDX has a dedicated urology sales force of about 60 (at my last count a year ago) and they have indicated that OncoType Dx Prostate will, when approved by FDA roll out and be marketed in the US (at urology clinics) by GHDX's sales force. I would not be surprised to here that this assay goes into validation late this year or early next.

    FL
  8. Flatlander 2 maart 2020 14:54
    Rarezot.
    Thanks for the ISO primer.

    It is my suspicion that the Idylla Console manufacturing has been contracted to Invetech of Boxborough Mass. I'm concerned that there could be virus related supply line issues/delays that stretch back to China. I think we can expect a discussion of this on the 5th.

    FL
  9. Flatlander 2 maart 2020 15:06
    I really don't want to see this link buried without a decent discussion of the market research it provides.

    www.eacorp.com/wp-content/uploads/201...

    It highlights the size of the opportunity, the growth rate of genomic MDx, pricing and identifies competitors and some inherent advantages of Idylla. No one player has yet become dominant so the market is wide open. Idylla is at the cusp of having a POC product and is turning from RUO to diagnostic approval. I believe this bodes well if BCART executes on the approval process.

    FL
  10. brightlight 2 maart 2020 19:19
    quote:

    Flatlander schreef op 2 maart 2020 15:06:


    I really don't want to see this link buried without a decent discussion of the market research it provides.

    www.eacorp.com/wp-content/uploads/201...

    It highlights the size of the opportunity, the growth rate of genomic MDx, pricing and identifies competitors and some inherent advantages of Idylla. No one player has yet become dominant so the market is wide open. Idylla is at the cusp of having a POC product and is turning from RUO to diagnostic approval. I believe this bodes well if BCART executes on the approval process.

    FL

    Talking about the size of the opportunity, Biocartis themselves indicate on page 11 of their corporate presentation that the total addressable market for Idylla (as far as annual cartridge volume is concerned) should range between 18M and 29M. It is not clear what percentage of that market they aim to capture. Let's take 10% of the low end, namely 1.8M cartridges sold per year. Multiply that by 100 Euro (approximate average selling price last year) and you get a peak sales value of 180M Euros. Currently, sales (for cartridges) are at roughly 18M Euro (the exact number we will know on friday). So in that scenario there is the potential to multiply cartridge sales by 10. The question is of course WHAT exact market share they are aiming for and WHEN they will reach those numbers. It would be nice if Bcart would shed some clarity on these numbers next friday. We cannot compare (exactly) the Bcart number to the numbers in your market study, because only the numbers for the Genomics MDx market as a whole are provided in the study. These numbers speak of 1660M$ for the year 2020. It is not clear what time frame the Bcart numbers refer to, still their numbers seem to be roughly in the neighbourhood of the market study numbers. Anyway, FL, what is your take on the possible Bcart market share and what is your take on the 'when' question?
    BL
  11. brightlight 2 maart 2020 19:54
    FL,
    could you provide me with the sales (and if possible expense) numbers of Cepheid in the 5 to 10 year period running up to the take-over? Cannot find those numbers on the internet anymore. Also, would be interesting to see the share-price evolution in the years before the take-over.
    BL
  12. Flatlander 2 maart 2020 23:18
    BL

    Looks like the link worked. Based on the 10 yr old Cepheid power points you can see that they project that the MDx market is likely to be larger than that estimated by the EACORP link. It is interesting that CEPH introduced an infinity system that could multiplex a much greater number of PCR analyses (48) concurrently. I'd have to believe BCART could do the same if they felt there was enough demand.

    FL
  13. brightlight 3 maart 2020 10:16
    quote:

    Flatlander schreef op 2 maart 2020 23:11:


    BL

    Not sure if this will work, but some of my historical Cepheid files can be found at the attached link.

    www.dropbox.com/sh/a8b4xxu1hn24l3d/AA...

    Thanks, the link works. Will come back to this with some comments after I analyzed the data.
    BL
  14. brightlight 3 maart 2020 12:06
    quote:

    CGCDLR schreef op 28 februari 2020 19:19:


    Voila!bijgekocht(4,89).Biocartis is nu mijn grootste positie.Cijfers van donderdag moeten er bonk erop zijn,dat weet ik,dan nog hopen op een iets beter "beursklimaat"(?).Cash,zo'n 3€/a.Het resterende is maw. De waarde die de markt toekent aan bedrijf.Mijn inziens is dit een lachertje.

    Iedereen wacht op donderdag, zoveel is duidelijk. Echter, CGCDLR heeft een punt. Eigenlijk betalen we momenteel maar 2 € per aandeel. Dit is uiteraard meer dan belachelijk, kafka eigenlijk.
    BL
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