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I guess I really should have read all of the posts before leaving my previous post. Great job BL with the potential news summary. It precisely makes the point that there are a lot of catalysts that can change the trajectory quickly. Crum's backward looking valuation does not address any of the likely news flow for 2020. Some of these events may be very market moving, What good is an analyst that that releases the upgrade after the news is already out and the price has run up. I'd much rather have the information we are sharing here. I'm really encouraged to see so many substantive contributors to this board. Often boards become diminished by group think reinforcing behavior. If you read the EXAS or GH boards, things tend to get out of hand with the vocal opposition to opinions that do not justify ever higher valuation. In that type of environment, there is no-place for dissenting opinions. As I have said before, I'd rather not see that happen here.. I feel comfortable enough in the Due Diligence I conducted into BCART before investing that I'd welcome any fact based information (pro or con). BL I wish I could fill in some of the blanks you have identified. However, the press releases are deliberately vague on many of these details. FL
I had one addition to item No. 12 in BL's list. I thought I remembered that in the conference call BCART indicated that Nichirei Bioscience would roll out Idylla in 2000 of its labs upon successful registration. I went back to check the statement and found it in the Feb 28, 2019 call (H2 2018 call) at about 19.5 mins. What might Idylla's 1st half of 2020 look like if just 25 or 50% of theses systems are rolled out. How quick would Mr. Crum have to reassess his hold rating under such a development. Clearly Nichirei will be an active user if they will be registering individual assay content. I'm certain that there will likely be some discounting but nevertheless The number of Idylla consoles in operation could ramp very quickly. FL
FL thanks for the wise an encouraging words, as always. Indeed you remembered well that Nichirei has 2000 labs as customers. Imagine what it would do to console and cartridge sales once their sales start gaining traction. Over the week-end I have been looking at the Biocartis numbers in more detail. there is a lot that can be extrapolated from the numbers. For instance the average cartridge sale price averaged over the past 3 years between 104 and 117 Euro. The average console sale price varied between 12837 and 17701 Euro. I suppose the big variation in avg console price is explained by the fact customers can add a Bcart workstation for analysis or not, and a more or less extensive software suite. In the past I have seen console prices on this forum fluctuate between 5000 and 50000. I don't know where that info came from, but I believe (but I can be mistaken) my numbers are more precise. The point I am getting to is that the initial investment in a console isn't that big a hurdle for the average hospital. BL
The US IVD market will open in 2020. Biocartis already sells a lot of RUO systems and assays to big cancer clinics in the US. FDA clearance for the CRC MSI (companion diagnostics with Bristol-Myers Squibb) will be the first IVD approval in the US. FDA clearence (IVD Market access) can go very fast for medical devices. What is a FDA 510(k) clearance? www.emergobyul.com/resources/fda-510k... Interactive review process 90 FDA (calendar) days.www.fda.gov/about-fda/510k-submission...
Heeft er iemand een idee wanneer die FDA-goedkeuring kan bekomen worden.Kunnen de conecties van aandeelhouder Johnson&Johnson daarbij soms helpen.In afwachting dat die goedkeuring dichterbij komt moet dit toch een ongelofelijke trigger zijn om de koers naar boven te krijgen?
joe123 schreef op 13 januari 2020 11:27 :
Heeft er iemand een idee wanneer die FDA-goedkeuring kan bekomen worden.Kunnen de conecties van aandeelhouder Johnson&Johnson daarbij soms helpen.In afwachting dat die goedkeuring dichterbij komt moet dit toch een ongelofelijke trigger zijn om de koers naar boven te krijgen?
Connecties zijn zeker belangrijk, maar de kwaliteit van het medische instrument blijft toch belangrijker. En de kwaliteit is erg hoog vergeleken met alle concurrenten. Biocartis heeft grote Amerikaanse Pharma partners (Amgen en Bristol-Myers Squibb) voor de eerste FDA goedkeuringen. Biocartis mag al leveren voor de RUO markt, maar met de IVD markt erbij verdubbeld de afzetmogelijkheid. Ik verwacht de indiening voor de IVD markt (voor MSI CRC) bij de FDA uiterlijk eind februari 2020. Zie de laatste ontwikkelingen van het complete Idylla test menu in de bijlage.
Ziet er allemaal razend interessant uit. Hopelijk wordt dit jaar de grote doorbraak.
This is an interesting article that has some relation to OncoTypeDx Breast Assay. Furthermore, no threat to BCART or that there is an urgency to read it.Google and cancer : Google has another big step forward in applying machine learning to medicine: using AI and computer vision to improve breast cancer screening. A big part of the machine learning story is that you can automate dull, repetitive tasks that previously still needed people, and get a repeatable, consistent and scalable result. In the last 150 years we went through successive waves of this kind of automation, from mechanical production lines and machine tools to databases, and now ML lets us apply it to another category of task.blog.google/technology/health/improvi...
D.vdB schreef op 13 januari 2020 13:51 :
[...]
Connecties zijn zeker belangrijk, maar de kwaliteit van het medische instrument blijft toch belangrijker. En de kwaliteit is erg hoog vergeleken met alle concurrenten.
Biocartis heeft grote Amerikaanse Pharma partners (Amgen en Bristol-Myers Squibb) voor de eerste FDA goedkeuringen. Biocartis mag al leveren voor de RUO markt, maar met de IVD markt erbij verdubbeld de afzetmogelijkheid.
Ik verwacht de indiening voor de IVD markt (voor MSI CRC) bij de FDA uiterlijk eind februari 2020. Zie de laatste ontwikkelingen van het complete Idylla test menu in de bijlage.
Bedankt D vdb. Nog even wachten dus. Misschien komt men met meer nieuws hierover in de US deze week.
BL I posted those numbers based on the listed prices on the Fisher exchange before the agreement was terminated. $5000 U.S. was for the single model console and $45000 U.S was the 8 unit model. The assay cartridge costs ranged from $800 to $1500 for a pack of 6 assays. The average was about $!200 U.S. These numbers clouded my earlier estimates of when BCART could become profitable. I believe I floated 350,000 units would get them to profitability. However, like most things health care related it is now apparent that the unit rate costs in the U.S. are higher than the rest of world. Depending on the geographic mix of sales, whether higher priced units are moving, and the support revenues, profitability can probably be achieved at around 450,000 units. The May 9 2018 post on this board provides a summary of an interview with Verrelst in it he indicates the ave cost per cartridge was $117 EU in 2017. Multiply by 6 and convert for currency exchange rates and the cost approach the $800 lower bound of US pricing. The costs would reflect the initial production line costs. The costs should be reduced significantly with the new production line, thus improving profit margins. In the interview Verrelst discusses profitability occurring at annual turnover of 500,000 cartridges. This was before the 2nd production line, so the operating costs should be reduced so profitability can be achieved at a slightly lower turnover. Hence my revised estimate of 450,000. The other interesting thing from that interview was that the cost of the 2nd line was quoted to be $20 million EUR, Verrelst indicated the cost for a third line would be much less since the engineering design costs have already been incurred so the designs can just be copied to the new location. That makes me hopeful that the China startup costs will not be that great. FL
Voor de geïnteresseerde. Zie bijgevoegd de link naar de meest recente Corporate presentation van Biocartis gedateerd 9 Januari 2020:investors.biocartis.com/en/corporate-...
Thanks for posting more on the FDA 510K process. Moving more assays out of the RUO category and into diagnostic use is absolutely critical to increasing uptake. The problem with the procedures outlined comes down to the comparison to a "predicate device". More than likely Idylla is having to go down the the de Novo pathway. I'm hopeful that the JnJ approval for the RSV assay helped break some ground with FDA in gaining acceptance. Unfortunately, I think some of the timelines get stretched under the De Novo process. Past experience with biosimilars show that FDA tends to get bogged down when operating outside pathways spelled out by legislation. Ultimately, comparisons of IVd results to other approved NGS lab based tests should rule the day. All that I have read tells me the results are good and it is a matter of "when and not if" the approvals come. FL
I would say the market opportunities expand by much more than a factor of 2 when the IVD assay goes from RUO to approved for full diagnostic use. A factor of 10 or more is probably closer since insurance coverage can be secured after diagnostic approval. The insurers ought to love Idylla since it has the potential to significantly cut costs of lab diagnostic services, inappropriate treatment etc. I can't comment on the approval date since there are a lot of variables, exact date of submittal, status of negotiations, need for bridging or validation testing, etc. I'm pretty certain once the initial assay for oncology is approved the pathway will be paved for subsequent assays. FL
Archer &_Illumina targeting same market segment. The good news is that faster, decentralized testing closer to the point of care (POC) is becoming an emphasis of major players. This validates BCARTs business models and assumptions. The bad news is that Illumina brings considerable funding and market branding to this fight for market share. BCART has some advantages such as: speed. lower costs, ability to achieve results from samples that fail NGS testing, established partnerships, etc. However, this combination provides a strong incentive for BCART to expedite FDA registrations. FLwww.clinicalomics.com/topics/precisio... archerdx.com/archerdx-and-illumina-pa...
Vandaag, BCART: 6,390 +0,190 (+3,06%) Een stijging van ruim 3% op een negatieve Belgische beurs (en Europese beurs). Dit is een teken van kracht. Stijging van het handelsvolume van Gem. 163,3K ,287% Binnen 30 dagen is het aandeel ruim 17% gestegen… Laten we maar niet meer speculeren over in- en uitstappers en hun motivaties…
An addendum to my last post. Illumina is also partnering with Roche to target the same POC/small lab space with their NextSeq 1000 and 2000 products. They seem very aggressive in that they are signing up buyers for a product that will not be released before the Q4 2020. Something (not necessarily just BCART) seems to be making them nervous. This could also be a reaction to Fisher targeting the same POC/Fast TAT space. If the Illumina equipment is priced 210,000 and up (not including reagents/IVD Kits), BCART appears to have a cost advantage. BCART needs to press registration FDA etc. and sales as fast as possible, before Illumina tries to steamroll into this space. finance.yahoo.com/news/illumina-annou...
MisterPink schreef op 13 januari 2020 19:02 :
Vandaag, BCART: 6,390 +0,190 (+3,06%) Een stijging van ruim 3% op een negatieve Belgische beurs (en Europese beurs). Dit is een teken van kracht. Stijging van het handelsvolume van Gem. 163,3K ,287%
Binnen 30 dagen is het aandeel ruim 17% gestegen…
Laten we maar niet meer speculeren over in- en uitstappers en hun motivaties…
Mede gezien deze hoge volumes, nu reeds 3 dagen achtereen, lijkt het erop dat het aandeel door "de markt" terug richting een hoger (handels)niveau wordt geduwd. Waar dit niveau dan uiteindelijk ligt is nog de vraag. Zelf denk ik dat we op korte termijn zeker terug kunnen naar boven € 7,-. Dat de koers vervolgens (kortstondig) blijft "hangen" tot een eerstvolgend nieuwsfeit is wat mij betreft een realistisch korte termijn scenario.
Reply schreef op 13 januari 2020 19:30 :
[...]
Mede gezien deze hoge volumes, nu reeds 3 dagen achtereen, lijkt het erop dat het aandeel door "de markt" terug richting een hoger (handels)niveau wordt geduwd.
Waar dit niveau dan uiteindelijk ligt is nog de vraag. Zelf denk ik dat we op korte termijn zeker terug kunnen naar boven € 7,-.
Dat de koers vervolgens (kortstondig) blijft "hangen" tot een eerstvolgend nieuwsfeit is wat mij betreft een realistisch korte termijn scenario.
Tjah @Reply, zou goed kunnen zijn. Aandeel/koers heeft zeker de neiging om bij nieuwsabsentie te blijven hangen op een bepaald niveau. @FL, 5 maart 2020 gaan we vaststellen wat ze doen om de Amerikaanse markt alsnog te veroveren en zaken te bespoedigen. Desnoods bellen we weer even. Ik heb het (nog) niet verpest bij ze...;) MP
MisterPink schreef op 13 januari 2020 21:42 :
[...]
Tjah @Reply, zou goed kunnen zijn. Aandeel/koers heeft zeker de neiging om bij nieuwsabsentie te blijven hangen op een bepaald niveau.
@FL, 5 maart 2020 gaan we vaststellen wat ze doen om de Amerikaanse markt alsnog te veroveren en zaken te bespoedigen. Desnoods bellen we weer even. Ik heb het (nog) niet verpest bij ze...;)
MP
Beantwoorden ze geen mails? Dan hebben we meteen een versie die achteraf niet gecorrigeerd moet worden.
brightlight schreef op 13 januari 2020 22:50 :
[...]
Beantwoorden ze geen mails? Dan hebben we meteen een versie die achteraf niet gecorrigeerd moet worden.
Haha! Dat lijkt wat minder omslachtig... Ik zou zeggen stuur ze zelf een mail met vragen. Voor mij is het sociale aspect ook belangrijk. En 'de kleur' van de stemmen die ik hoor. Zo heeft ieder zijn eigen methodes.;) MP
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