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[verwijderd] 5 maart 2021 19:19

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I agree with that! your knowledge goes beyond mine. I stay
positive about biocartis, not about the price, but this is a temporary problem. I think pushing the price and then bringing in shares in a capital increase is what we are seeing. painful in the short term (unless you can buy extra) in the long term positive. biocartis needs a few larger shareholders. in any case, I am happy that you are staying on the forum!

Flatlander 5 maart 2021 21:45

5

BCART is still growing the top line faster than the MDx sector as a whole. Meanwhile the oncology portion of the MDx sector remains fragmented. If you further subdivide into NGS and PCR (I think winners will arise from both), it is apparent that the oncology MDx market remains up for grabs. If you look at the advantages (fast TAT, lower costs, less technician hands on time, fewer failures, less complicate/actionable interpretation etc.) I still see a reasonable path for BCART to be very successful and a X5 or X10 bagger. Unfortunately, currently BCARTs cost increases largely keep pace with the sales growth increases, such that profitability gets kicked down the road. I understand the need to build product portfolio, sales and distribution channels and a worldwide footprint is is setting the stage for future growth. But I really have trouble with the last step (product IVD registrations) blocking the pathway to profitability. It seems that diagnostic product approval pathway should not be more onerous than that of a pharma product that could have significant unforeseen side effects.

I'm encouraged that BCART is moving MSI registration forward in the USA and the same for Septicyte rapid. A few months ago I wanted them to push EGFR forward but now I'd just assume they improve the T790M mutation sensitivity before doing so.

Unlike a lot of investments that have a well defined exit trigger point. The Idylla product and market could set the stage for a decade or more of strong growth. New biomarkers emerge every year, so the market can grow almost indefinitely. I'm in wait and see mode. Wait to see if BCART delivers on the new product launches, wait to see if the IVD registrations are successful, wait to see product uptake by intended markets (smaller hospitals labs, physician practices etc and not just researchers), wait and see what competition arises for the same niche.

This weeks downturn appears to be associated with factors affecting story stocks as a whole and not anything unique to BCART. Simply, the market is discounting distant future earnings against increasing bond yields and fears of inflation. I suspect the gene fusion RUO release in the next week or two will provide some an exit point that allows a firm bottom to form. The potential for major upside surprises exists, so I'm content to hold and continue to do research. I've said this several times, my holdings in Genomic Health pretty much tripled in a month or two after the release of the Tailorx study at ASCO. Long term holders of GHDX (knew for years) the predictive value of the OncotypeDx breast assay but the market needed the major study to confirm it. BCART is in this phase, it needs the traction from positive research studies but more importantly, it needs the IVD approval so that the product is widely available and covered by insurance when the research papers stir up interest.

Have a good weekend.

FL

OzDx 6 maart 2021 13:51

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Hi, I'm a new investor in Biocartis. I have come across $bcart by accident and this has quickly become my highest conviction stock. Having witnessed Cepheid's GeneXpert taking over the diagnostic labs around the world, I am very hopeful that Biocartis will follow similar path.
Can someone enlighten me why $bcart had a sell off in 2018-19? Not sure what happened there.. :)
Thanks in advance.

DeZwarteRidder 6 maart 2021 17:07

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quote:
OzDx schreef op 6 maart 2021 13:51:
Hi, I'm a new investor in Biocartis. I have come across $bcart by accident and this has quickly become my highest conviction stock. Having witnessed Cepheid's GeneXpert taking over the diagnostic labs around the world, I am very hopeful that Biocartis will follow similar path.
Can someone enlighten me why $bcart had a sell off in 2018-19? Not sure what happened there.. :)
Thanks in advance.

I'm afraid you are lost.............

Flatlander 6 maart 2021 18:05

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OxDx

The largest portion of the decline occurred in Sept 2019 when BCART announce 1st half 2019 results below expectations. They attributed it almost entirely to problems with the Fisher Distribution performance. They announced the termination of the distribution agreement and the establishment of their own sales force in the US. In hindsight I posted some examples of Fisher at the same time trying to launch their own scaled down cheaper NGS system to address the point of care MDx market (in direct competition with Idylla). So it is questionable as to how much effort the Fisher sales people were making to place Idylla units over their own equipment. Since that point sales of both consoles and cartridge's in the US have been on a better trajectory. However as I harp on ad nauseum, the RUO market is only a small fraction of the US oncology MDx marketplace. IVD approvals from the FDA and insurance reimbursement codes open Idylla for much wider use in the US. Insurance will have every incentive to extend coverage because Idylla is cheaper than NGS. I believe the lions share of the market will be in surveillance applications where a patient is on a treatment say Tagrisso for NSCLC and they need to be periodically tested for the development of EGFR mutations that will limit the effectiveness of the drug. It is expensive to utilize NGS every few months to conduct such surveillance, so I think Idylla will be popular with oncologists.

BCART is a high risk -reward situation. They are a microcap company in the midst of launching a unique product worldwide in one of the highest growth areas (personalized medicine) where like Cepheid the growth trajectory will likely ramp for decades. Other than the NGS system manufacturers (Illumina and Fisher) Oncology MDx is a pretty wide open marketplace. A lot of Cepheid's success comes from the Emerging Markets, the density of NGS systems is not as great in EM due to cost limitations, so they are very receptive to cheaper faster options.

This will be an interesting year, coming out of the pandemic there will be increased demand for oncology MDx at the same time that lingering infectious disease MDx continues. BCART needs to show that they can reduce cash burn at the same time they start filing worldwide approval registrations. If they can succeed with this at the same time they introduce the new products they promised then they will be setting the launchpad for future growth.

Welcome to the Board.

FL

CGCDLR 6 maart 2021 20:53

1

Yep,he's back DZR !Lijkenpikkers bestaan al sedert de middeleeuwen.Toen hadden ze een adequaat middel om er vanaf te komen.??

DeZwarteRidder 6 maart 2021 21:03

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quote:
CGCDLR schreef op 6 maart 2021 20:53:
Yep,he's back DZR !Lijkenpikkers bestaan al sedert de middeleeuwen.Toen hadden ze een adequaat middel om er vanaf te komen.??

Je bedoeld de pest.....???

CGCDLR 6 maart 2021 21:06

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Ik had het over een adequaat middel

OzDx 7 maart 2021 01:43

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Thanks for that. Appreciate it. I have been working in a diagnostic lab for over a decade and I've seen the rise of many different new tech over the years. Everything and I mean every little things take years to gain traction in the diagnostic market due to very very strict regulation and reluctance to change by incumbent management and pathologists. Cellavision, ROTEM, GeneXpert and MALDI-TOF come to mind (not in any particular order ??) . I think septicyte and the new pan-respiratory panel will be a game changer for Idylla platform. Infectious disease market will be a lot easy to penetrade than the oncology market. Precision medicine have just started making traction and you'll just have to be patient as an investor in my opinion.

Flatlander 7 maart 2021 01:48

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OzDx

What is your professional/investing background that you have " witnessed Cepheid's GeneXpert taking over the diagnostic labs around the world". The Danaher earnings reports certainly corroborate that statement. Cepheid is the growth engine fore the company. The parallels between the two platforms and business models are unmistakable. However, the oncology POC market is slower to develop than infectious disease. Both Illumina and Fisher have scaled down NGS platforms that seek to capitalize on the POC market. Their offerings are about 10X the cost of an Idylla platform. The interest and investments that these two behemoths are making to access the POC marketplace makes me more confident that oncology MDx will move from centralized labs to the POC.

Another factor that has worked against Idylla in the past is that the US has made it easy for Laboratory Developed Tests (LDT) to be launched without any FDA approvals. However, it is harder for them to gain insurance reimbursement. If BCART can start getting IVD approvals (they are filing for MSI in a couple months) then insurance reimbursement codes should follow shortly thereafter. This will provide an advantage over many LDT. Obviously they have to repeat this process for multiple assays. However, I anticipate that the process should get easier after they can get the first oncology MDx approval under their belt.

FL

OzDx 7 maart 2021 09:20

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Thanks for your insight. Definitely helps me get a full picture of Biocartis' journey so far.
I work in a pathology laboratory in Australia and this is my own anecdotal experience that once some new technology starts picking up, it's likely to grow exponentially over time. I've seen it with Cepheid recently and other products mentioned above. I first heard of GeneXpert back in 2014 and labs in Australia were slowly adopting the platform. It started with MTB/RIF panel if I recall correctly. Then now most hospital labs with emergency department probably has at least one GeneXpert equipped. Same goes with ROTEM/TEG. Technology was there years ago but it just takes years or even over a decade to pick up traction in sales. I'm not making parallel comparison for Idylla and GeneXpert and other new entrants, but with already over 1000 installed base and growing at double digit yoy, I reckon it'll grow quite fast over the next decade in Oncology and infectious diseases. It provides unique solution to oncology clinics and core laboratories around the world. More I study the business, I'm getting more conviction in the Biocartis. Good luck to all share holders! :)

OzDx 7 maart 2021 13:11

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Should also add there is a company called t2 biosystems that offer similar solution to Septicyte and is fda approved already. Wonder how Septicyte will fare vs t2

Flatlander 7 maart 2021 19:41

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OzDx

Thanks for confirming my re-evaluation of my BCART investment. I now realize that I was way to early (i.e., 1st inning) and that oncology MDx will likely play out over a decade or more. Based on my reading of pathology journal reviews, I thought it was a no brainer that the market would adopt Idylla to automate the many steps in PCR analysis, but I totally misjudged the relative pace of adoption. My example of GHDX tripling in SP in a couple months emphasizes how fast the turn can come.
I've now taken the attitude that I should reassess progress toward meeting milestones and watch the competition closely but need to allow more time for the thesis to play out. Diaceutics has a number of market research analysis papers out there that suggest that suggest that the Oncology MDx industry will become more decentralized as a result of the Covid pandemic. This suggests that analyses might begin to migrate closer to the patient care setting. Do you see this as a likely outcome of the pandemic?

I have enjoyed investing in the diagnostic space. Some earliest investments in the space go back 20 years to Vysis shat was acquired by Abbot. Also had long term holdings in FMI, Bruker, GHDX and LH. The diagnostic space valuations ran up tremendously in the US, which got me looking abroad. Last year I invested in Novacyt (ALNOV.PA) and I'm still holding a sizeable house money position. They are very quick to introduce new pandemic related products to the market. Novacyt is also a partner of Immunexpress and I wonder if an announcement of a joint venture product release is on the horizon later this year. They will desperately need to pivot from a COVID based stable of products. The Sepsis Host Response space is about to get pretty competitive. Inflammatix has indicated that they will introduce a rapid Host Response system this year. T2 seems to have focused on fast identification of the underlying pathogen rather than the broad immune system host response. They look like they got hit hard after their earnings announcement last week.

Since you are in the industry, do you have an estimate of how the RUO market differs in size from the market available for full IVD diagnostic approval. My qualitative estimate is that RUO represents only about 10% of the full IVD market. I kind of view the number of Independent user papers authored each year as the best indication of RUO interest in the Idylla platform.

I'm looking forward to your contribution to the board.

FL

OzDx 8 maart 2021 02:10

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Flatlander,

I'm not sure if we'll see decentralized oncology MDx testing any time soon. There are many factors that might deter oncology clinics from running their own MDx testing. Most of the regulators only allow these tests to be performed by trained staff (techs, scientists) in an accredited labs. I'm assuming these analysers including Idylla will need regular maintenance, quality control, calibration etc. It also has to be cost effective. Depending on the size of the oncology clinic, it has to be big enough to justify equipping the Idylla platform. In saying that, if the clinic is big enough, they already probably have a small core lab at the clinic. However, it'll only take a handful of leading oncologists to adopt and change the landscape of oncology testing. So I'm happy to be proven wrong here...

I don't have any insight into RUO space so I don't know if I can be of any help there. But from my investing and personal experience (I mostly invest in diagnostic companies), if a company is breaking into diagnostic field fast and growing its installed base in a double digit, it's still not late to invest. Most of the companies that were already dominating pathology diagnostic space say 5-10 years ago have easily more than doubled in that time span. Biorad, Abbott, Illumina, Siemens healthineers, Sysmex, Danaher, Qiagen, Thermo Fisher, they were already big 10 years ago. People thought they were expensive back then because they had high PE ratio. What people forget to think is, diagnostic companies are protected from inflation(price of the products will increase with inflation by medicare/insurance) ,benefits from aging population (number of testing at pathology labs have been growing high single digits yoy) and more and more.. If you find a pure diagnostic company and is shown to grow its installed base in a double digit, I'd hold onto it and watch it compound for the next decade... I think Biocartis at the moment is in the sweet spot, it's NOT pre-revenue or early in the adoption curve like a lot of other diagnostic with BIG promises. With total revenue of about USD$60M in 2020, I'd like to see it grow at least 50% yoy coming out of pandemic. If for whatever reason, product revenue falls down to single digit growth from its low-ish, I'll probably make my exit but I'm hopeful that it'll continue growing fast. See www.sonicgenetics.com.au/our-tests/al... Sonic labs in Australia is offering EGFR screen on Idylla platform but has turn-around-time of 5-10 days. If they're happy with the performance, they'll more than likely install more modules and reduce specimen backlog and increase TAT and also offer Idylla testing for other cancer markers. I believe many labs around the world is still at that stage where they're still trying out the new tech and once they find benefits of this easy-to-use, fast TAT Idylla platform, they'll ramp up the adoption.

Sorry I tend to ramble a bit, hope this answers your question. A lot of this is from my anecdotal experience so take it with a grain of salt, i must say. :)

Flatlander 8 maart 2021 05:40

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OzDx

Rambling is fine, I often do a fair amount of it in my posts. I should correct my comment about decentralization. The Diaceutics market research I mentioned was specific to the impacts that COVID was having on the MDx industry, They used EGFR as an example. They noted that the secondary tier cities in China had only about 20% of the NGS capacity found in western countries. Coming out of the pandemics first wave they saw that the primary testing facilities were inundated and that TAT was significantly lengthened. They stressed decentralization as a means to alleviate overtaxing testing capacity. Obviously decentralization cannot be achieved quickly without steps and considerations you have outlined. BCART highlighted on the Feb 25 call that they had successfully completed Idylla compliance testing with the China NMPA in January 2021. It seems like they are positioning to be able to offer a low cost Idylla MDx solution in China (non RUO market) sometime in 2022. However from what I understand the Chinese reimbursement system requires a couple year period of demonstrating effective low cost performance before an instrument is eligible for cost reimbursement from the provinces. This is encouraging, but it will likely take a couple years, at least to develop into a significant contribution to the top line.

I did check out the Sonic Lab site, the first thing that struck me was the Covid delay notification. Is Idylla approved to perform EGFR for diagnostic purposes in Australia? if so, I can see where Idylla could save a lot of technician time and effort. Again, I worry about the reduced T790M mutation sensitivity that has been the focus of recent journal articles. The amplification curve issue is being corrected but it will likely take until the next release in 2022 before the issue is addressed.

Your take on assessing the growth trajectory is very similar to what I have said numerous times, The overall oncology MDx market is estimated to be growing at 20% per annum. So as long as Idylla's uptake remains appreciable above that figure I feel like they are growing market share. Doing that while reducing costs and improving margins will be critical to the long term survival of the company

I'm not sure if I'm in total agreement on your statement on inflation. Companies like NVTA have made it their stated goal to reduce the cost and TAT for providing NGS MDx services. It seems like this can lead to lower reimbursement rates and potential commoditization. About a year ago BrightLight (another board poster) and I had a thread going on this board where I was able to find insurance reimbursement rates for several common assays ( KRAS, NRAS, BRAF, EGFR, MSI etc). I recall that the insurance reimbursement rates in the US were stable over a three period and were on average about 100% higher than the Idylla cartridge sales price. This research encouraged me that if Idylla could gain the FDA approvals, they could compete very effectively on cost savings. I've thought they they could even use the difference between the reimbursement rates and the cartridge costs to provide users an incentive to drive system adoption. I probably need to revisit the reimbursement rates to see in the potential margins have eroded by reimbursement rate changes.

One last thing, I've attributed pure inertia as a delay factor for the adoption of Idylla. Labs and hospitals have a set process work flow and are hesitant to disrupt it. That is why I often highlighted the Clinical Pathology Journal articles and the MSK study that highlighted with flow charts how Idylla can be integrated into standard work flow to save time and money. There is a lot of discussion that NGS sequencing is all that is necessary and that focused PCR panels will have little place in the market going forward. However, the process flow diagrams underscore how the two techniques can be used in a complementary fashion. I think this will be especially true as more of the market shifts to surveillance monitoring. Obviously, if you are investing, you agree that there will remain a place for PCR oncology MDx. The NGS space is pretty crowded, one of things that attracted me to BCART was that it provided a potentially disruptive technology in a niche growing market space that is not as crowded.

Regards
FL

chob 9 maart 2021 07:41

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beste , mijn engels is niet super maar mag ik eruit afleiden dat we nog goed zitten bij biocartis ?

Iceman 10 maart 2021 11:58

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mijn engels is ook niet wat het moet zijn, echter op jaarbasis merk ik steeds een licht dalende trend. ik begin me ook stilaan zorgen te maken. had steeds de gewoonte als de koers 15% lager lag dan mijn gemiddelde om bij te kopen... nu echter begin ik te twijfelen... is er ergens een lichtpunt waar we ons kunnen aan optrekken?

Flatlander 10 maart 2021 15:49

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I can offer several rays of hope.

I follow a basket of diagnostic stocks (TTOO, TECH, FLGT, ALNOV.PA, NVYTF,NSTG, QTRX, NTRA, OCX NEO VCYT MXDHF EXAS GH A NVTA QTNT ARYC QGEN ILMN HTGM TMO AXDX LMNX) Yesterday was a big mover day for many with several up double digits. BCART has the lowest valuation metrics in the field. (P/S, P/B, EV/R, etc.). That can be argued two ways 1) the company's prospects are not as good as the others or 2) BCARTs visibility is lower than the others by virtue of being listed outside the US (not on Nasdaq). Looking at the fact that BCART is launching an existing validated product worldwide that seeks to automate MDx reducing labor, expense and TAT associated with MDx, I think the problem is the visibility issue. Most of the basket firms, are focused on the US and are not launching into the worldwide market in the manner that BCART is launching Idylla. As Cepheid has shown, launching this type of a cartridge based systems can set the stage for long term growth.

Over-valuation has a way of catching up with a firm in the long run. So all things being equal the lower valuation, while painful looking backwards looks to be setting the stage for the future. The platform, partnerships and distribution systems are in place, what remains is launching additional content, securing IVD registrations and marketing/improving product traction. The increase in research papers show that traction among users is increasing organically. At some point after registrations, BCART will benefit from the pharma partnerships. It the difference in TAT helps a large pharma company secure a script over a competitor, you can bet they will market and advocate for the use of Idylla systems.

Long story short, by virtue of launching a unique product that automates MDx worldwide the addressable market reward potential is greater than just about any other MDx stock I follow, Because the valuation is low (I believe due to the Brussels exchange visibility issue) the risk is lower than most MDx companies. Unfortunately, as OxDx has explained, industry adoption/progress are slow in general. Coming out of the pandemic with lingering infectious disease testing and a huge ramp in oncology MDx as patients get the testing done that were deferred during the pandemic should set the stage for a good year. Throw in the IVD registrations in the US, China and Japan and I'm remaining optimistic enough to give BCART another year and reassess progress in 12 months.

FL

Iceman 10 maart 2021 16:15

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Tnx flatlander

GC 10 maart 2021 18:12

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Ha ha, per ongeluk het verkeerde bedrijf ingegeven. Wilde bpost kopen en nu onbewust aandeelhouder van Biocartis. Nooit gehoord van dit bedrijf De order gelukkig wel uit gevoerd aan de actuele koers. Ipv 8,10 ingegeven. Nu even inlezen met welke activiteiten het bedrijf zich bezig houdt.

Vertraagd	22 sep 2023
Koers	0,290
Verschil	0,000 (0,00%)
Hoog	0,000
Laag	0,000
Volume	0
Volume gemiddeld	0
Volume gisteren	112.228

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