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Flatlander
1
Mister Blue

Thanks for spelling out your thoughts in detail. You have espoused several of the same thoughts that I have mentioned in the past. Right now many laboratories are still trying to figure out their MDx sample analysis work flow. The Idylla IVD is positioned to provide actionable answers for front line physicians. The more focused the question the more appropriate the Idylla assay. OncoDx is such an Assay. Determining if a woman will benefit from chemotherapy in a hour or two will spare many women the unnecessary side effects of chemo. The CDX tests are similarly focused. Answering whether a patient has the specific mutation that will respond to a drug, is critical. I can see insurers and pharma companies as being quick to reimburse or pay for the test. For a Pharma company the costs of acquiring a user of their drug may be well worth the initial cost. Right now, I think the market is going nuts for NGS ability to map out all the gene variants in a patient even though the genetic counselors or Drs may not know what to do with all of the data. The insurers are more likely to want the less expensive test that just answers the question whether a the patients tumor will respond to a given drug. Their is a time and place for NGS capabilities (looking at mutations that develope resistance etc,) but right now I think simple actionable results are going to find a healthy market. GHDX has evolved their tests around this concept. The key is moving from RUO to clinically approved.

Welcome and thanks for your contribution.
Regards FL
Noob nr1
0
@ Mister Blue
Bedankt om uw visie zo goed te omschrijven. Hopelijk rap US FDA goedgekeurde testen
Reply
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quote:

Flatlander schreef op 27 november 2019 19:22:


JnJ sold a relatively small stake. They have opioid related lawsuits to prepare for and have a large number of programs to fund and have dividend payments to make. The old adage that stock sells tell you little since there are many reasons to sell a stock but there is only one reason to buy.

www.cbsnews.com/news/federal-criminal...

FL


Tot op heden is er inderdaad slechts een relatief kleine verkoop door Johnson & Johnson bekend waarbij het feit blijft dat men hiermee onder de kennisgevingsdrempel van 10% is gezakt.
Voor "de markt" lijkt dit feit voorlopig geen aanleiding te geven om dan nu massaal aandelen te gaan inkopen.
Daarbij zal er ook de onzekerheid meespelen of Johnson & Johnson op korte termijn niet nogmaals enkele kleine pakketten aandelen zal gaan verkopen, om welke reden dan ook?!
Indien zo, is het zeker niet uitgesloten dat de koers nogmaals onder de € 6,- zal gaan noteren. Waarom dan nu (bij)kopen?
Beter eerst even enkele weken afwachten tot duidelijk is of Johnson & Johnson nog verder zal gaan afbouwen.
DeZwarteRidder
0
quote:

Reply schreef op 29 november 2019 12:28:


[...]
Tot op heden is er inderdaad slechts een relatief kleine verkoop door Johnson & Johnson bekend waarbij het feit blijft dat men hiermee onder de kennisgevingsdrempel van 10% is gezakt.
Voor "de markt" lijkt dit feit voorlopig geen aanleiding te geven om dan nu massaal aandelen te gaan inkopen.
Daarbij zal er ook de onzekerheid meespelen of Johnson & Johnson op korte termijn niet nogmaals enkele kleine pakketten aandelen zal gaan verkopen, om welke reden dan ook?!
Indien zo, is het zeker niet uitgesloten dat de koers nogmaals onder de € 6,- zal gaan noteren. Waarom dan nu (bij)kopen?
Beter eerst even enkele weken afwachten tot duidelijk is of Johnson & Johnson nog verder zal gaan afbouwen.

Je zult niks horen van J+J, totdat de 5% grens wordt doorbroken.
MisterBlack
1
Als je in dit aandeel gelooft - en een lange adem hebt - koop dan gestaffeld of getrapt - in ieder geval over periodes in. Als je het aandeel tegen deze prijs niet wilt aanschaffen zou ik hard wegrennen en je op een alternatief richten. Het is inderdaad heel goed mogelijk dat het aandeel nog verder wegzakt. Dat hoeft helemaal niets te zeggen.

Verder gespeculeer over me dit en me dat is zinloos. De enige meetpunten die ertoe doen zijn de verkoopvolumecijfers, te beginnen met Q4 2019 en vervolgens Q1, 2, 3 en 4, 2020. Als de groei einde 2020 niet versnelt dan gaat Biocartis naar de marge van de MDx-markt. Ik zie echter veel kansen en weinig bedreigingen. (Zie mijn eerdere stuk en de posts van FL die ik hartelijk bedank). Ik meld me weer ten tijde van eindejaarcijfersbesprekingen van Biocartis. Iedereen vast fijne feestdagen gewenst.
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MisterBlue schreef op 29 november 2019 13:56:


Als je in dit aandeel gelooft - en een lange adem hebt - koop dan gestaffeld of getrapt - in ieder geval over periodes in. Als je het aandeel tegen deze prijs niet wilt aanschaffen zou ik hard wegrennen en je op een alternatief richten. Het is inderdaad heel goed mogelijk dat het aandeel nog verder wegzakt. Dat hoeft helemaal niets te zeggen.

Verder gespeculeer over me dit en me dat is zinloos. De enige meetpunten die ertoe doen zijn de verkoopvolumecijfers, te beginnen met Q4 2019 en vervolgens Q1, 2, 3 en 4, 2020. Als de groei einde 2020 niet versnelt dan gaat Biocartis naar de marge van de MDx-markt. Ik zie echter veel kansen en weinig bedreigingen. (Zie mijn eerdere stuk en de posts van FL die ik hartelijk bedank). Ik meld me weer ten tijde van eindejaarcijfersbesprekingen van Biocartis. Iedereen vast fijne feestdagen gewenst.



Er is momenteel geen reden hard weg te rennen bij dit fonds.

Gezien echter het feit dat een recent verkopende grootaandeelhouder toch ook enige onzekerheid met zich meebrengt en tevens, zoals je zelf terecht aangeeft, als enige meetpunten de verkoopvolumes ertoe doen, waarvan pas de eerste cijfers van Q4 2019 in Maart 2020 bekend worden, verwacht ik zelf nog enige verdere verkoopdruk. That's all.
Flatlander
0
I really don't expect the share price to fall below the floor of 5.40 that has been set. The sales growth is approximately the same as the overall growth rate for MDx sector as a whole. So while BCART is not currently taking much share and growing faster than the market as a whole, they deserve a market multiple share price for growing at approximately the rate of the industry as a whole. As I have said before, I think the upside potential is 10X because BCART represents a platform and an ecosystem that stands to be a disruptor (by automatizing a labor intensive process) in a disruptive space (genomic testing). But BCART has a ways to go before they can realize substantial share price appreciation. Launching the new products (OncoDx Breast, Septicyte, gene fusion), securing regulatory approval for clinical use, and securing China registration are the next major milestones. These events will create the 2020 inflection point in the growth trajectory that I often reference.

Yahoo shows the price/book of BCART as 2.74, the lowest of the genomic testing companies that I follow. This reflects the fact that BCART has physical assets like manufacturing lines and inventory. The market capitalization of 350 million Euro is pretty minuscule considering the intellectual property, product registrations, potential market opportunity, (potential for geographic expansion, increased product uptake, additional services, etc). For these reasons, BCART is my favorite highly speculative stock investment.

FL
DeZwarteRidder
0
quote:

Flatlander schreef op 29 november 2019 18:43:


I really don't expect the share price to fall below the floor of 5.40 that has been set. The sales growth is approximately the same as the overall growth rate for MDx sector as a whole. So while BCART is not currently taking much share and growing faster than the market as a whole, they deserve a market multiple share price for growing at approximately the rate of the industry as a whole. As I have said before, I think the upside potential is 10X because BCART represents a platform and an ecosystem that stands to be a disruptor (by automatizing a labor intensive process) in a disruptive space (genomic testing). But BCART has a ways to go before they can realize substantial share price appreciation. Launching the new products (OncoDx Breast, Septicyte, gene fusion), securing regulatory approval for clinical use, and securing China registration are the next major milestones. These events will create the 2020 inflection point in the growth trajectory that I often reference.

Yahoo shows the price/book of BCART as 2.74, the lowest of the genomic testing companies that I follow. This reflects the fact that BCART has physical assets like manufacturing lines and inventory. The market capitalization of 350 million Euro is pretty minuscule considering the intellectual property, product registrations, potential market opportunity, (potential for geographic expansion, increased product uptake, additional services, etc). For these reasons, BCART is my favorite highly speculative stock investment.
FL

Never fall in love with a stock.
Flatlander
0
DZR I thought the first part of my post was pretty sober. I'll ask another question that I'm fairly interested in that shows I'm not always wearing rose colored glasses when it comes to BCART. Is Rudi Pauwels still involved with Biocartis? He has an intriguing history an an entrepreneur having been a founder or co-founder of Tibotec, Virco, Galapagos and Biocartis. I know he stepped aside when Herman Verrelst was brought in as CEO. I assumed that he had less interest in the day to day CEO responsibilities but was remaining as part of the Biocartis brain-trust. I'm no longer certain this is the case but other than the following link describing his involvement as Chairman of the Board for Midiagnostics, I've not seen any PR indicating he has ended his involvement with Biocartis. He is a guy that would obviously be in demand as an outside board chair, so I don't necessarily take this as a statement about him terminating his involvement with Biocartis. Anyone local, have more information on Mr. Pauwels?

FL

www.imec-int.com/en/articles/midiagno...
[verwijderd]
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quote:

Flatlander schreef op 29 november 2019 22:37:


DZR I thought the first part of my post was pretty sober. I'll ask another question that I'm fairly interested in that shows I'm not always wearing rose colored glasses when it comes to BCART. Is Rudi Pauwels still involved with Biocartis? He has an intriguing history an an entrepreneur having been a founder or co-founder of Tibotec, Virco, Galapagos and Biocartis. I know he stepped aside when Herman Verrelst was brought in as CEO. I assumed that he had less interest in the day to day CEO responsibilities but was remaining as part of the Biocartis brain-trust. I'm no longer certain this is the case but other than the following link describing his involvement as Chairman of the Board for Midiagnostics, I've not seen any PR indicating he has ended his involvement with Biocartis. He is a guy that would obviously be in demand as an outside board chair, so I don't necessarily take this as a statement about him terminating his involvement with Biocartis. Anyone local, have more information on Mr. Pauwels?

FL

www.imec-int.com/en/articles/midiagno...


www.tijd.be/ondernemen/farma-biotech/...
Flatlander
0
Thanks

I had hoped that Pauwels was still involved with long term strategy/product development in some way. Often there is a shift from a founder to a more business oriented leader but continuing involvement of the founder as a visionary (when it can be achieved) is a positive. With the exception of Fisher (US distribution) the partnerships to not appear to have suffered as a result of the management changes. That and progress toward the goals remain critical regardless of the brain trust.

FL
[verwijderd]
0

Flatlander,

Patrick Casselman is a stock specialist at BNP Paribas Fortis. He gives these stock tip in a personal title.
"Biocartis saw its course cut in half due to a temporary growth slowdown in 2019. We continue to believe in considerable growth potential. We rely on his technological lead. The ease of use and the speed of diagnosis (which is crucial for cancer treatment) ensure that the minilabo Idylla has good chances of a strong expansion and that it can acquire a meaningful market share in the fast-growing market for molecular cancer diagnosis (now 1.5 billion euros) ). The growth slowdown this year is a result of the longer than expected validation process by American hospitals."
Reply
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quote:

Laup 4 schreef op 2 december 2019 20:33:



Flatlander,

Patrick Casselman is a stock specialist at BNP Paribas Fortis. He gives these stock tip in a personal title.
"Biocartis saw its course cut in half due to a temporary growth slowdown in 2019. We continue to believe in considerable growth potential. We rely on his technological lead. The ease of use and the speed of diagnosis (which is crucial for cancer treatment) ensure that the minilabo Idylla has good chances of a strong expansion and that it can acquire a meaningful market share in the fast-growing market for molecular cancer diagnosis (now 1.5 billion euros) ). The growth slowdown this year is a result of the longer than expected validation process by American hospitals."



Dit persoonlijke bericht van deze analist dateert reeds van 7 Oktober. Destijds sloot de koers nog op € 6,41

We noteren nu bijna terug op € 6,- en er is nog geen vertrouwen terug in de markt, waarbij het eerst mogelijke bewijs van verder herstel pas op 5 Maart 2020 zal zijn met de jaarcijfers 2019.

Het heeft er dan ook alle schijn van dat het aandeel vooraleerst terug zal gaan onder de € 6,-
Indien zo, zal er hopelijk ergens op € 5,- plus een "definitieve" bodem worden gevormd.
Flatlander
0
I consider the difference between 6.41 and 6.00 essentially noise. You really cant hold this type of a speculative biotech/genomic testing company without the potential of a 10% haircut at any moment. As I've said before, my anticipated hold/re-evaluation period is through 2020 and into early 2021. If the re-evaluation metrics are met then my hold period gets extended. Potentially for a long time! BCART does have first mover advantage and a considerable lead. However, that does not mean that a better financed competitor with a deep technology background cannot unseat them and render Idylla obsolete. I think considerable effort went into the front end design of the console and the cartridges in order to make the system user friendly in a front line patient/physician environment without a ton of training. I'd like to see the system deployed into that environment rather than just the larger research hospitals and labs. Hence the need to move beyond RUO designation.

I'd love to see BCART shorten the time frame from initial proof of concept to EU Marking or FDA Registration. Currently the process seems to take an average of about two years and probably varies considerably with the complexity of the assay. As the staff gathers more experience, I'm hopeful this time frame can be reduced. However, given the technical and regulatory hurdles, I'm not sure what a reasonable expectation is as to what is the minimum amount of time required to complete the process. For now, I watch their partner relationships for clues as to what will happen in the future. From what I can see, the partners continue to make milestone payments for advancing the assay development (based on the 6.8 million in collaborative revenue in the last income statement) . I believe this is a positive indication that the partnership goals are continuing to be advanced to the satisfaction of both parties.

FL
MisterBlack
0
Ik kan het toch niet laten te reageren op de laatste post van FL. Ik ben blij dat deze nieuwe CEO is aangesteld. Hij heeft namelijk een automatiseringsachtergrond en bij een databedrijf gewerkt. Ik verwacht van hem dat hij de ingeslagen weg van ICT-integratie met de labo-software gaat voortzetten en uitbouwen waardoor samenspel met andere test-technologieën en automatische bestellen van cartridges gerealiseerd wordt. Hierdoor worden weer data gegenereerd waar biocartis wat aan heeft.

Een blik op dia 12 van de bedrijfspresentatie toont dat er per lab relatief weinig en meer van dezelfde tests/cartridges worden besteld. Hierin liggen kansen tot verbetering verkoopvolume aangezien Biocartis momenteel moet wachten op andere manieren om de verkoop te vergroten. Immers, het bedrijf wacht op de FDA goedkeuringen om haar minilabo’s bij de kleinere klanten te kunnen plaatsen om zo cartridges aan de man te kunnen brengen. Een blik op dia/pagina 11 van haar bedrijfspresentatie toont hoeveel testen/assay’s nog wachten op FDA-goedkeuring en wat een potentie ontstaat als dat gebeurt.

Welke MDx-bedrijven concurreren met Biocartis? Voor welke testen zijn er alternatieven? Wat zijn de voor- en nadelen van die testen in vergelijking tot die van Biocartis?

Er is momenteel veel beweging in deze sector. Illumina gaat samenwerking aan met ArcherDx op NGS IVD tests. Ambry Genetics en Caris Life Sciences zijn actief in genetische kanker testen. FDA keurt CDx Foundation Medicine goed voor het specifieke medicijn van Novartis Piqray voor borstkanker. Enzovoort.

MB
Flatlander
0
Thanks MB.

I always value insights on what competitors are doing. Your post also emphasizes what I feel is BCARTs natural market (the smaller hospitals, clinics, Dr offices etc.). The larger facilities have an abundance of trained personnel, access to NGS, sufficient space etc.). Based on the medical journal reviews (primarily Journal of Clinical Pathology), I have confidence that the FDA approvals are a question of when not if. These approvals are major hurdle and will unlock the smaller user market since these facilities are focused on clinical diagnosis and not "research".

In the US, there is an increasing trend toward direct to consumer marketing of molecular diagnostic tests. I'm constantly seeing ads for Cologard from EXAS or the Foundation One test from Roche running on TV. Idylla may never be appropriate for TV ads but the FDA approvals would open the door as to how BCART can market the platform to Drs, clinics, etc. BCART has partnered many of its assays with big pharma companies that work with FDA on a regular basis. These partnership relationships should help move Idylla tests through FDA approval process faster than BCART could do if acting alone. I also feel that having US based partners is also key in an FDA that maybe becoming increasingly politicized.

Regards FL
Flatlander
0
Foundation Med recalls MSI assay tests due to MSI high false positives. Good time to have a cheaper faster product on the market. Good time to get expanded FDA marketing approval.

FL

In Brief This Week: Foundation Medicine, PerkinElmer, Enzo Biochem, and More
Dec 06, 2019 | staff reporter
Save for later

NEW YORK – Foundation Medicine has recalled a number of its FoundationOne CDx tests because they contained a potentially false-positive microsatellite instability (MSI)-high result, according to a recent entry in the US Food and Drug Administration's Medical Device Recalls database. The company voluntarily initiated the recall in August, informing physicians by phone that they may have received an incorrect MSI-high result in their report and asking them not to use this result to prescribe treatment. All physicians said that no treatment plan utilizing the MSI result had been applied, according to the entry, and eight reports were affected in total. According to Foundation Medicine, the issue came to light during a routine review of sequencing data and the reports were recalled within 24 hours. The eight cases were part of more than 90,000 total cases, of which more than 1,800 had true MSI-high results.
Flatlander
0
Fisher Sales conflicted??

The more I browse competing product offerings, the more it appears that the Fisher sales team may have had conflicting interests. For instance here is a promotion for a NSCLC Gene fusion assay on Fishers Ion Torrent.

www.htgmolecular.com/assays/lung-fusions

FL
Reply
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quote:

Flatlander schreef op 6 december 2019 23:33:


Fisher Sales conflicted??

The more I browse competing product offerings, the more it appears that the Fisher sales team may have had conflicting interests. For instance here is a promotion for a NSCLC Gene fusion assay on Fishers Ion Torrent.

www.htgmolecular.com/assays/lung-fusions

FL



Then it is extra good that Fisher has been dumped.

Nevertheless, the share price continues to flinch.
MisterBlack
0
quote:

Flatlander schreef op 5 december 2019 16:02:


Thanks MB.

I always value insights on what competitors are doing. Your post also emphasizes what I feel is BCARTs natural market (the smaller hospitals, clinics, Dr offices etc.). The larger facilities have an abundance of trained personnel, access to NGS, sufficient space etc.). Based on the medical journal reviews (primarily Journal of Clinical Pathology), I have confidence that the FDA approvals are a question of when not if. These approvals are major hurdle and will unlock the smaller user market since these facilities are focused on clinical diagnosis and not "research".

In the US, there is an increasing trend toward direct to consumer marketing of molecular diagnostic tests. I'm constantly seeing ads for Cologard from EXAS or the Foundation One test from Roche running on TV. Idylla may never be appropriate for TV ads but the FDA approvals would open the door as to how BCART can market the platform to Drs, clinics, etc. BCART has partnered many of its assays with big pharma companies that work with FDA on a regular basis. These partnership relationships should help move Idylla tests through FDA approval process faster than BCART could do if acting alone. I also feel that having US based partners is also key in an FDA that maybe becoming increasingly politicized.

Regards FL


Waar letten we op bij de eindejaar presentatie in 2020?

Beste FL, ik krijg van je laatste post toch een beetje de indruk dat de minilabo’s en cartridges van Biocartis vooral goed zijn voor streekziekenhuis en (plattelands)dokters ??. Je kunt zeker gelijk hebben dat de ‘consumer – market’trend gunstig is voor de producten van Biocartis. Ook werken ze het snelst, kennen ze het meeste gebruiksgemak en zijn ze in vergelijking tot de concurrentie zeer betrouwbaar. Toch worden de producten van Biocartis ook gebruikt in grote laboratoria. De testen sluiten vervolgstappen uit of wijzen ze aan, al dan niet in samenspel met andere technologieën, op zeer overtuigende wijze. Helaas blijft dat vaak beperkt tot 1 of 2 testtypes per lab.

Biocartis heeft echter 19 testen in ontwikkeling (gehad) waarvan er 12 zijn afgerond. Van die 12 hebben inmiddels 11 Research Use Only-status, 9 zijn er klinisch gevalideerd en CE-IVF toepasbaar. 3 testen zijn object van studie in een pre market approval onderzoek FDA, en 1 test wordt nu gekeurd om geregistreerd te worden als een officiële medische test door FDA. Vele zullen nog volgen. Al deze testen zijn en worden ontwikkeld in samenwerking met gerenommeerde partners als: Merck KGaA, Bristol-Myers Squibb, AstraZeneca, Genomic Health, Life Arc, Kite Pharma (Gilead).

Waar ik op let komend jaar:

Bij de verkoopvolumecijfers moet er ook een toename zijn van cartridge gebruik per lab/bestaande klant. Als de toename enkel wordt gerealiseerd door nieuwe markten is dat een veeg teken.

Voor mij is belangrijk dat er geen partners afvallen maar juist bijkomen. Positieve signalen zijn ook wanneer er feitelijke aanwijzingen zijn van testen naar de zinvolheid van het gebruik van medicijnen/behandelingen van deze partners. Vooral de laatste drie partners vind ik in dit verband erg interessant. De koppeling (blockbuster)-medicijn en/of gangbare dan wel nieuwe behandeling én een bepaalde test wordt van vitaal belang. Denk ook aan immunotherapie/CAR-T. Biocartis moet haar partners blijvend aanspreken.

Er moeten in 2020/2021 veel PB’s komen over gerealiseerde RUO’s, PMA’s en FDA approval’s.

Verkoop groei moet vanaf Q3 2020 minimaal 50% zijn.

2021 Q1 moeten er duidelijke aanwijzingen dat niemand meer om Biocartis heen kan in de MDx markt.

Waar let jij op? Wat mis ik? Ben ik redelijk?
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