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Aandeel Biocartis BRU:BCART.BL, BE0974281132

  • 0,290 22 sep 2023
  • 0,000 (0,00%) Dagrange 0,000 - 0,000
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Biocartis forum geopend

6.444 Posts
Pagina: «« 1 ... 152 153 154 155 156 ... 323 »» | Laatste | Omlaag ↓
  2. brightlight 10 juni 2020 16:46
    quote:

    Flatlander schreef op 10 juni 2020 14:47:

    If by mid 2021 we are talking about console placements well in excess of 2500, the system will have the kind of momentum that attracts partners and new content.
    FL

    FL,
    Well in of excess 2500 placements by mid 2021 would be a dream come true.
    Let us assume for the sake of argument 2600, that is approximately 1000 added by half year or let's say 2200 by year end.
    The maximum number added per year currently stands at 337. So you are talking about a high triple digit percentage increase. I wonder, is this number just whishfull thinking or is it based on some sort of calculation? Please explain.
    BL
  3. Flatlander 10 juni 2020 20:31
    BL

    Quite simply four factors account for my optimism:

    1) This will be a critical need infectious disease triage product in the midst of a pandemic. The market research that we posted several months ago indicated that the infectious disease market is roughly 3 times the size of the total oncology MDx market during normal times. Probably 5 to 10 times larger during a pandemic;

    2) Septicyte Rapid is not a RUO launch it will be approved for full diagnostic use. This means that rather than research academic hospitals etc, the market expands to pretty much all hospital emergency rooms and ICUs; The Rapid test blood draw is now less than 1.0 ml making it appropriate for infants and children. Potentially this market can expand beyond the ER and ICUs to nursing homes and other high risk facilities. I have previously estimated that RUO was less than 10% of the overall diagnostic market, so this would be a huge expansion of the target market;

    3) There are very few competitor Sepsis tests especially rapid host response based tests;

    4) Sepsis is a very expensive condition to treat. The costs can be reduced with early diagnosis. Thus, there is strong inducement to adopt a fast TAT MDx test to reduce overall treatment costs. The cost of a console placement is relatively low relative to the overall cost of treating a Covid patient. If it allows better triaging of ER patients it probably reduces the overall liability in cases where a patient is not admitted.

    So given these factors and the fact that BCART has expanded sales force to meet demand, I think the number of consoles in use, could easily double in a short period of time. An important caveat. I'm assuming the U.S. validation study will show strong utility for COVID 19 induced sepsis diagnosis that will be quickly published in a recognized medical journal.

    By my estimate, the target market is probably 30 to 100 times larger than the oncology RUO market BCART is currently serving throughout the majority of the world. Given the critical need for the product, I believe console placement will break out of the relatively linear growth mode. The bigger questions in my mind are as follows:

    1) What is the royalty rate on Septicyte Rapid and how much will it add to the bottom line;
    2) Will BCART continue to place consoles at close to cost if demand surges? or will they offer a lot of lease arrangements? and
    3) To what extent can BCART use the console placements to ramp sales of other assay cartridges.

    I realize that we are just beginning the launch, so it is a crap shoot to make such prognostications. However, the combination of the unmet need and the much larger target market make me optimistic.

    FL
  4. brightlight 10 juni 2020 21:46
    Don't you think the still small U.S team (20 persons, maybe a bit more with the new hirings, a number which includes not only the sales persons but also, I would assume, sales support, and maybe some lab technicians) will be a limiting factor? Suppose they can sell as many consoles as they want, then lets do the math.
    Assuming there are 15 sales persons and 5 support staff. To get to a number of 1725 consoles sold, they have to sell one console every two days. (=15 persons X 230 working days /2).
    One every 3 days amounts to 1150 consoles sold.
    I sure hope they can pull that of but I am afraid a larger sales force may be needed.
    BL
  5. Flatlander 10 juni 2020 23:56
    BL

    The U.S. commercialization is the responsibility of ImmunExpress and not BCART. Part of the private financing round they did in early October last year was to staff up for this launch. You are right that technicians could be a limiting factor. But Immunexpress has advertised training sessions which they conduct with their people. I think a certain amount of cross training has occurred between BCART and ImmunExpress. ImmunExpress took the lead on all of the ISO certification, so I think their working knowledge of Idylla is pretty strong.

    There are about 5000 hospitals in the U.S. Assuming they can achieve 10% penetration (500 units) would go along ways toward my projection. Much of this depends on the timing of FDA approvals relative to a pandemic 2nd wave and the results of the COVID/Sepsis validation (yes, I'm certain there will be significant pandemic in the fall).

    Jane Papadaki Markley, is the ImmunExpress VP in charge of the commercialization in the U.S. Here is her PR statement.

    www.prnewswire.com/news-releases/immu...

    ImmunExpress presented Idylla data at the 40th International Critical care Conference in March (P482). The results looked good across all demographic groups. I anticipate that the results of the COVID 19 -Sepsis validation will be much more important in driving sales as a triage assay.

    Regards FL
  7. brightlight 11 juni 2020 18:28
    quote:

    Flatlander schreef op 10 juni 2020 23:56:

    BL

    The U.S. commercialization is the responsibility of ImmunExpress and not BCART. Part of the private financing round they did in early October last year was to staff up for this launch. You are right that technicians could be a limiting factor. But Immunexpress has advertised training sessions which they conduct with their people. I think a certain amount of cross training has occurred between BCART and ImmunExpress. ImmunExpress took the lead on all of the ISO certification, so I think their working knowledge of Idylla is pretty strong.

    There are about 5000 hospitals in the U.S. Assuming they can achieve 10% penetration (500 units) would go along ways toward my projection. Much of this depends on the timing of FDA approvals relative to a pandemic 2nd wave and the results of the COVID/Sepsis validation (yes, I'm certain there will be significant pandemic in the fall).

    Jane Papadaki Markley, is the ImmunExpress VP in charge of the commercialization in the U.S. Here is her PR statement.

    www.prnewswire.com/news-releases/immu...

    ImmunExpress presented Idylla data at the 40th International Critical care Conference in March (P482). The results looked good across all demographic groups. I anticipate that the results of the COVID 19 -Sepsis validation will be much more important in driving sales as a triage assay.

    Regards FL
    FL

    I thought you were referring to the Covid-19 - SepticyteRAPID combination. My mistake if you weren't. As it now stands, only the SepticyteRAPID test will be marketed by ImmunEx)press. The sales of the Covid-19 test will still be up to Bcart, if I am not mistaken. However, come to think of it, it would make a lot of sense if ImmunExpress would market the combination in the U.S..
    I was really surprised to read ImmunExpress appointed a Vice President no less!, to set up and lead the SepticyteRAPID sales force.That means they seem to attach a lot of importance to that.product. It would imply the focus will be on RAPID rather than SepticyteLAB.
    About your console placement numbers, I believe you are still a bit optimistic when you say ImmunExpress can add 500 consoles by mid 2021 or even by end 2021..It will all depend on how large the dedicated sales force will be. You must also not forget ImmunExpress will most likely first target the hospitals/labs that already have an Idylla. Their aim is to first sell their product.
    This being said, I believe 2021 will be the year that sales will ramp up significantly. The Septicyte test will be a major contributing factor, but so will the additional sales from China and Japan, the new MSI pan tumor test and the Genfusion breast cancer test. A lot of things are converging.

    BL
  8. Flatlander 11 juni 2020 21:44
    BL

    Part of my optimism stems from ImmunExpresses private financing partners.
    JnJ or at least the Janssen Family and Debiopharm Diagnostics (see link below). Both of these organizations would have considerable reach into hospitals. It is interesting that JnJ drew down their BCART stock holdings at the same time ImmunExpress did their private financing. Unfortunately, since they are privately held I cannot verify that JnJ increased their funding of ImmunExpress in October.

    I don't think that marketing the locations where there are existing consoles will be a particular emphasis. The SOFA scoring guidelines require initiating treatment in 3 hrs (preferably in an hour). The risk of mortality increases about 8% per hour that treatment is delayed. For this reason, I don't think the ER or ICU physicians will want to be running across hospital complexes to access a machine in oncology unit or in the lab. The hospitals employing RUO devices tend to be large places. They will want to place the console in immediate proximity to the point of use (i.e., ER and ICU). Septicyte lab has a 4-6 hr TAT with several steps, so it is complex and misses the treatment guideline time window. For this reason it never gained traction.

    I'm pretty sure we will see considerable ramp in console placement. I'm totally unsure what it will mean to profitability. Once again, we really do not have the information required to assess profitability (royalty rates etc.). I'm convinced that if BCART can figure out a way to expand the infectious disease consoles to use for there oncology assay offerings it will accelerate the path to profitability. However, as we have discussed this will require successful IVD registration (starting with MSI and EGFR). This might be more of a possibility in smaller hospitals.

    FL
    www.bizjournals.com/seattle/blog/heal...
  9. Flatlander 11 juni 2020 22:42
    BL

    Septicyte and COVID19 will be separate cartridges. I don't think that Septicyte release will be delayed in any way until COVID is ready and received EU approval. I think BCART will be responsible for COVID sales and distribution in all geographies. However, I'm sure ImmunExpress will make Septicyte purchasers aware of its availability.

    FL

  10. Flatlander 11 juni 2020 22:55
    Cepheid Modified their RSV cartridge system and won Emerg Use Authorization in less than 2 months. This is exactly what BCART is proposing to do. The Cepheid GenExpert COVID 19 cartridge test is said to be 98% accurate.

    So I think it is reasonable to expect an announcement of the BCART COVID test any day now.

    FL

    www.massdevice.com/cepheid-wins-emerg...

    www.npr.org/sections/health-shots/202...
  11. brightlight 12 juni 2020 08:33
    quote:

    Flatlander schreef op 11 juni 2020 21:44:

    BL

    Part of my optimism stems from ImmunExpresses private financing partners. ...

    ... I'm pretty sure we will see considerable ramp in console placement. I'm totally unsure what it will mean to profitability. Once again, we really do not have the information required to assess profitability (royalty rates etc.). I'm convinced that if BCART can figure out a way to expand the infectious disease consoles to use for there oncology assay offerings it will accelerate the path to profitability. However, as we have discussed this will require successful IVD registration (starting with MSI and EGFR). This might be more of a possibility in smaller hospitals.

    FL
    www.bizjournals.com/seattle/blog/heal...
    FL
    I am also starting to get more optimistic as far as the 2021 outlook is concerned.
    Concerning MSI (colorectal) and EGFR, we already have CE IVD registration. So I suppose you are referring to ctEGFR and MSI (pan-tumor) or MSI CDx for Opdivo? Which of these is the one you expect most of?
    BL
  13. Flatlander 12 juni 2020 14:46
    quote:

    brightlight schreef op 12 juni 2020 08:33:

    [...]
    FL
    I am also starting to get more optimistic as far as the 2021 outlook is concerned.
    Concerning MSI (colorectal) and EGFR, we already have CE IVD registration. So I suppose you are referring to ctEGFR and MSI (pan-tumor) or MSI CDx for Opdivo? Which of these is the one you expect most of?
    BL
    BL

    I was speaking of the challenge of how BCART can take advantage of increased console placements (albeit for sepsis) to encourage usage for oncology assay use. This is no small task given how hospitals are configured. They will have to do some ground work to determine the best approach for cross selling oncology assays.

    With regard to MSI or ctEGFR, they will need to cross sell any and all products that fill a need. Currently based on conference calls BCART has said Europe's uptake/interest in the CRC panel (MSI, KRAS, NRAS etc) is far greater than in the U.S. The interest in the U.S. is reportedly far greater for the lung panel. I watched the MSK webinar on ctEFGR and was impressed by their workflow organization and the potential to use Idylla to reduce NGS costs by 25%. This would allow the Idylla cost savings to pay for itself over time. However, they have not even started FDA negotiations for approval of EFGR let alone ctEFGR in the States yet, so the cross selling in the US, initially will be limited to MSI and KRAS, NRAS, BRAF (when they receive approval). In Europe the registration approvals allow much greater cross selling options. Based on what I saw on the MSK webinar I think there will be strong opportunities in the future for ctEFGR. The MSI, KRAS, NRAS, BRAF approvals mean that CRC will probably be the initial cross marketing target.

    We are obviously a little ahead of ourselves. Lets 1st look for evidence that the septicyte launch is going well. Hopefully, they provide some color in the Sept conf call. If they strictly stick to the 1st half cut-off they might only be obligated to discuss the initial week or two of the launch (assuming it has occurred in June).

    FL
  15. Flatlander 12 juni 2020 15:13

    BL

    The other reason for my optimism on Septicyte and the number of console placements in the next year is based on the footnotes from p19 of the April presentation. It reads as follows:

    "2 Moreover, SeptiCyte® RAPID not only discriminates sepsis from SIRS but also correlates with viral sepsis infection, versus procalcitonin (PCT) which increases with severity
    of bacterial but not viral infection and is also a non-specific marker of inflammation"

    PCT is one of the primary indicators of sepsis currently utilized. I think Septicyte will correlate much closer to COVID viral load induced sepsis. This should make it very useful for triaging patients in an EU setting.

    FL
  18. Flatlander 12 juni 2020 17:29
    I have not asked Renate. The January PR indicated that the results of the validation studies being conducted in the EU would be used to support registrations throughout the world. I assumed that included the USA. So I assume they will probably begin that process in early 2021.

    Given the present environment, there is considerable emphasis at most biotechs on preserving cash. This may be a consideration on how many registrations BCART pursues at any point in time. The next year will be a difficult period for conducting any financing. BCART has gone on a hiring spree in Belgium and the US. I assume they are also hiring in China. I assume much of this optimism is based on the positive catalysts expected in the next year. These hiring plans appear to be going forward despite the pandemic. My read is that much of the hiring is in anticipation of the market expansion that occurs when shifting from RUO to full diagnostic approval (whether infectious disease or oncology assays). Also, I don't think I've seen a microcap with as great an geographic exposure to both developed and emerging markets. It will be interesting to watch this play out. I still maintain that BCART is far below the radar of most investors. Although, this is probably a U.S. bias.

    FL
  19. brightlight 13 juni 2020 15:28
    quote:

    Flatlander schreef op 12 juni 2020 17:29:

    ... I still maintain that BCART is far below the radar of most investors. Although, this is probably a U.S. bias.

    FL
    FL,

    If you can explain to me why Tesla has a market valuation of over 2.5 times the entire Volkswagen Group (which includes Audi, VW, Bentley, Bugatti, Lamborghini, Skoda, Seat, Porsche, ...), while Tesla has a revenue of only one tenth of VW's and is making a loss a opposed to VW making a cool 10 billion net profits a year,. If you can explain that to me, then maybe I could explain why Bcart is undervalued as opposed to its US counterparts. To me the stock market is a complete nut-house at the moment.

    BL
  20. Flatlander 14 juni 2020 01:12
    I concur that the US market is a nuthouse.The argument use to be that Tesla wasn't an automobile company but rather a technology company. But others have made considerable strides on the battery technology and also self driving vehicles.

    Even more curious is how Hertz stock doubled in price while in bankrupcy and they got court approval to do an equity offering. I think there is a new generation of day trader that will trade momentum irregardless of any fundamental or balance sheet. These people do not understand that common equity almost always gets wiped out in BK. The court must figure a fool and his money will be parted they might as well use it to pay off the bondholders, banks etc.

    Have a good weekend.

    FL
6.444 Posts
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