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DRTVR 13 januari 2021 16:07

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quote:
Bob de Bouwer 59 schreef op 13 januari 2021 15:45:
Dank voor jullie info en inzichten.
Ik heb ze al sinds half 2019 voor €10 en €7,2
Voor de lange termijn ontwikkeling. Valt me echter wel tegen dat er geen reactie is ondanks hun activiteiten op covid gebied. Had een opwaartse trend verwacht sinds half 2020.
Zo'n mooi handzaam analyse apparaat zou nou toch geliefd moeten zijn. De recente tijdelijke stijging heeft lijkt me ook een verkoopreactie opgeleverd.
Iemand inzichten waarom wel een Kiadis door de grote Sanofi wordt opgekocht en BioCartis niet interressant genoeg is? Of zou het nog komen dit jaar?

Ik hou ze voorlopig nog aan en we gaan het zien. Succes allemaal.

Ik denk dat we qua verwachting 2021 moeten nemen ipv 2020 door het hele Coronagebeuren, en het is nog niet voorbij, ze hebben toch gehaald wat ze vooropgesteld hebben ondanks Corona, begin 2020 zat ik er vol vertrouwen in, ga ze dat vertrouwen nog verder geven.

Stockbrood 13 januari 2021 18:55

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Ik blijf ze toch ook volledig vasthouden. De koers verdient beter, of er nu geld getankt moet worden of niet. Het blijft mi ook een overnamekandidaat.

Toeval of niet, daarnet een tweet de wereld in rond hun genefusion assay:

@Biocartis_ is developing a fully automated, rapid and easy-to-use GeneFusion Assay on #Idylla, generating results in approx. 180 minutes with less than 2 minutes hands-on time! ??

Groeten Stock

RUF RTR 13 januari 2021 19:43

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Vond de bevestiging van hun jaarprognoses positief. Een nieuw product ontwikkelen en daar na 6 maand het gros van de omzet uithalen was een fenomenale prestatie. Vind de visie van KBC Securities terecht; de markt waardeert het aandeel Biocartis niet ten volle. Aan de huidige koers is het een zeer interessante investering.

Flatlander 13 januari 2021 22:20

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Bob
Verrelst is on record as saying his intent is to unlock the long term value of Idylla not sell it off. His statements have probably rebuffed some. More importantly, BCART has not demonstrated that an acquisition would be accretive any time soon. Therefore, I don't think potential acquirers are beating a path to their door. Two factors are necessary to change things. 1) registrations outside of the EU are necessary so that Idylla can move into the POC environment for which it was designed. 2) the menu of assay offerings has to expand quickly to encourage adoption.

Cepheid has found considerable traction in the emerging markets. Based on the NGS under-penetration in China, I have considerable hope for this market. However, hey have to find a way to accelerate registration filings.

FL

Flatlander 13 januari 2021 22:37

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I give BCART a lot of credit for cobbling together a strategy to meet their guidance. It is difficult in medical sales when your sales representatives are prohibited from in person marketing. Most Oncology focused MDx firms have similarly shifted or missed guidance. The big question going forward is where have the new consoles been placed? As the pandemic begins to wain, will these consoles contribute anything to oncology cartridge utilization rates?

FL

Flatlander 13 januari 2021 23:52

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Illumina CEO Discusses Pan-Cancer IVD Assay, CDx Collaborations at JP Morgan

www.genomeweb.com/molecular-diagnosti...

This statement is why I keep banging the drum about getting the registration approvals.

"Febbo noted that pursuing CDx partnerships would be important for getting reimbursement for the test, once it's available. "All you need is one companion diagnostic that's pan-cancer and that derisks reimbursement from Medicare for the IVD," he said."

FL

Phoene 14 januari 2021 02:19

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Ik wil eerste iedereen nogmaals bedanken voor het prima forum hier en de waardevolle posts. Hier enkele standpunten van mij op posts van de voorbije dagen.

@Gijpie, @flatlander, @tomtesteron
- De eerste productregistraties en commerciele verkopen voor China en Japan staan pas gepland voor eind 2021. ---> Herman Verhelst (Bolero tech Event www.youtube.com/watch?v=CzbrLFO5xx0 )

@Gijpie
- Voor Scepsis willen ze ook eerst studies afwerken om dan pas met de resultaten van de studies gemakkelijker commercieel te kunnen verkopen. ---> Herman Verhelst (Bolero tech Event www.youtube.com/watch?v=CzbrLFO5xx0 )
- Dat het aantal cartridges niet spectaculair stijgt ligt toch aan een groot deel dat er veel minder onderzoeken gebeuren omdat patienten hun onderzoeken naar kanker uitstellen. Als je hoort dat er veel minder kankers worden vastgesteld kun je hieruit opmaken dat er toch minder wordt getest en dus minder cartridges worden verkocht. Het hoofddoel van Biocartis blijft voorlopig nog altijd oncologie. Ze hebben de covidtest erbij genomen omdat ze merkten dat er vraag vanuit de USA kwam om deze ook op het platform te kunnen gebruiken vooral in de spoedgevallen. Ze bieden deze cartridges nu ook aan, enkel aan bestaande klanten en gaan er niet mee naar nieuwe klanten om deze te promoten. Ik denk niet dat je hier een grote boost moet van verwachten omdat ik 3 nadelen zie aan de covidtest. 1) is duurder dan een gewone test, 2) de beperkte capaciteit van het aantal testen Slechts een 160 testen indien je 24u op 1 Idylla werkt. 3) aankoop van een Idylla om de test te kunnen doen. Voordeel is wel dat je vlug resultaat hebt.
- Wat betreft de goedkeuring van de FDA voor de Covidtest vind ik het ook vreemd nog geen nieuws te hebben gehoord. Normaal was dat voor eind november 2020 voorzien. Ze mogen wel hun test commercieel verkopen in de USA zolang het onderzoek loopt.

@JotieP
- Hoe kom jij aan het aantal cartridges voor Q4 2020? Volgens mijn berekening (zie bijlage) zou dit ongeveer een (230.000-80.000-61290) 88710 moeten zijn. Ik denk niet dat er overal bussines as usual was in de ziekenhuizen ( België, USA, ...)
- Wat betreft de verkoopprijzen van de cartridges betreft zouden deze voorlopig rond de 105€ zitten. ---> Herman Verhelst (Bolero tech Event www.youtube.com/watch?v=CzbrLFO5xx0 ) De verkoopprijs stijgt hoofdzakelijk door de betere verkoop van cartridges in de USA waar ze duurder worden verkocht. Normaal zou nu het grootste deel van de cartridges nu ook op de tweede lijn (meer automatische) moeten verlopen wat de kostprijs een stuk naar beneden zou moeten drukken.

@Flatlander
- The new consoles for the H1 2020 where placed for 50% in Europe. It's the only number i can find.

@MB
- Spijtig te lezen dat je verlies moet nemen maar begrijp het wel aangezien je er al heel wat langer inzit. Hoop wel af en toe nog je waardevolle posts hier (& Mithra, vooral de liedjes ;)) te lezen

Zelf blijf ik nog minstens 1 jaar zitten. Ik heb nog steeds vertrouwen in het bedrijf en het product. Wel vind ik dat de communicatie soms wat beter kan zeker ivm de goedkeuringen van de FDA.

Phoene

Bijlage:

Flatlander 14 januari 2021 15:12

1

Phoene,

@Flatlander
- The new consoles for the H1 2020 where placed for 50% in Europe. It's the only number i can find.

My question was not so much one of geography as a question whether the consoles deployed for covid testing will find their way to oncology testing when the pandemic begins to wind down, Future growth projections of many are based on a utilization rate per console. This could be skewed, going forward.

Your emphasis on the deferred oncology testing creating a backlog for 2020 is one of the primary reasons that I feel there will be a large tailwind in the 2nd half of 2021. I have seen the schedule for registration filings in late 2021. My point is that they have have passed the head to head lab analytical evaluation (based on PR from WondfoCartis).. Perhaps they should explore the potential of an EUA based on the the simple fact that Idylla is proven to speed return of results (see AZN paper from Sept). NSCLC is very sensitive to time to the initiation of treatment, The end of the pandemic will result in the identification of more cancers than at any other point in history. There will be an unprecedented number of biopsies and a backlog to analyze. .The labs will also be slowed by labor issues and testing volume associated with Covid.

My point is that 3 or more years for critical assays to go from RUO to IVD is too long. JnJ cut through the red tape to get the RSV assay IVD approval from FDA on an expedited manner (in 2017 in about a year, I believe). They should have capitalized on the momentum and FDA learning curve/acceptance of the platform to start filing for other approvals. I realize this was done under prior management and that the FDA 510K process has been in a shambles so they might have thought it was prudent to wait for Scott Gotlieb when he was at FDA to reform the IVD device registration process, as he had promised. Well he quit and it never happened. I had hoped the 2018 deal to place JnJ staff in NJ on the Biocartis payroll would expedite this registration process, Now I look at the BCART U.S, hiring announcements and wonder how many of the JnJ personnel remain on the payroll and are continuing to work for BCART.

FL

Flatlander 14 januari 2021 17:05

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Looks like part of the previous message got cut off. It should read

I had hoped the 2018 deal to place JnJ staff in NJ on the Biocartis payroll would expedite this registration process, Now I look at the BCART US job listings and wonder how many of the JnJ staff remain with BCART.

FL

[verwijderd] 15 januari 2021 14:17

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Dag allen,

Ik volg het forum hier nu al een tijdje en wou toch ook even een opmerking maken over Biocartis.

Ik geloof nog altijd in het opwaarts potentieel van het aandeel. Zit wel al even op mijn honger te wachten maar heb altijd mijn positie weten aan te passen door bij te kopen en zo mijn gemiddelde koers te levellen.

Wat ik graag wou meegeven is een stukje technische analyse waar ik van vind dat toch zeker meespeelt in het BCART verhaal. In bijlage vind je een eenvoudige grafiek en in mijn ogen moeten we enkele dagen bevestiging hebben boven de dalende trendlijn waar we nu keer op keer op botsen. We zitten in de punt van de driehoek die gevormd wordt door de dalende en stijgende trendlijnen. Echter wilt een break down onder de stijgende lijn zeggen dat er mogelijks terug naar veel lagere punten gezocht gaat worden. We hebben begin deze week een eerste poging gezien om uit te breken omhoog, maar die is helaas teruggevallen tot in de driehoek. Ook gisteren en vandaag botsen we op die lijn. Hopelijk kunnen we hier dus snel door om zo richting de 5 euro en hoger te gaan op een aanzienlijk 'korte' termijn.

Mvg,
Anthony

Bijlage:

Bob de Bouwer 59 15 januari 2021 14:23

1

:) dat levellen is een doekje voor het bloeden; ik kan niet oneindig levellen.

Al klinkt het wel professioneel op de zoom-verjaardagspartijtjes

[verwijderd] 15 januari 2021 15:19

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Ja het is een doekje voor het bloeden, maar beter dat dan helemaal niets :D

Flatlander 15 januari 2021 15:43

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Anthony,

I observed a similar set up in August 2019 and probably wrote about it. I thought the long term ascending trend would reign but sadly in Sept BCART announced the end of the Fisher distribution agreement and the SP was cut in half. We have been mired here ever since.

That said, I'm optimistic for 2021. Coming out of the pandemic looks like a very powerful environment for BCART. The recently signed EU trade agreement with China should accelerate access to the market with the largest population in the world. The testing performance portion of the registration approval has been completed so I think they might be able to move up the registration if Brussels has laid the ground work to improve access to this market. Time for Wondfo to earn their keep.

Finally based on Verrest's previous statements, the gene fusion and ABC breast test should be introduced in earlier 2021. Also, the CDx partnerships have to be close to the point where they begin to bear fruit.

I'm also waiting to see if Citidel's covering of their short position is a reversal that results in them going long. The structure of the deal announced in December was not clear on the long term intent. It seems like if they simply wanted to exit the short it would have been simpler to buy the shares on the market and cover, I'm guessing they got something else to have redeemed the convertible at terms that were attractive to BCART. Perhaps they will place a representative on the BOD. Alternatively, BCART will likely raise cash later in 2021. I suspect they might want to do an IPO on the Nasdaq in late 2021. This would best be approached from a position of strength after new product releases and new geography registrations. Citadel might be angling for a sweet position in such an IPO. This is a lot conjecture but the IPO timing is similar to that of many European companies that have gone on to list in the US.

FL

Gijpie 16 januari 2021 10:21

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Flat , if a few of those ‘should’ would occur. I’ll be the first to buy. Given their track record on delivering previcous time tables it’s wait and see for the moment . By the way die you folow the tip on Tonix bought 0.59 sold 1.06 me very happy .

Flatlander 16 januari 2021 19:14

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Gijpie

"Flat, if a few of those 'should' would occur. I'll be the first to buy. Given their track record on delivering previcous time tables it's wait and see for the moment. By the way die you follow the tip on Tonix bought 0.59 sold 1.06 me very happy"

I did not, but thanks and congrats on the great entry and exit points. Nasdaq stocks under $ 1.00 can get hit with delisting notices that cut the value in half in a heartbeat. I also wondered how they had the financial strength to complete phase 3 trials. Guess, I should have dug deeper.

FL

JotieP 18 januari 2021 16:02

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Phoene

sorry for the late reply.

I used figures of Brightlight (23/09/2020) and added the growth rate communicated by biocartis.
I now compared with yours and i notice indeed differences. there is a difference in Q3 2017, 18000 vs 21000 cartridges. I've checked the press releases and i assume your 21000 is correct.

now i also notice an error in your Q3 2020.
the cartridges have increased in Q3 2020 with 61% Year on Year. the year to date growth was 27% ... so you should increase the 48.260 cartridges Q3 2020 with 61% to get the cartridges Q4 2020 ... and that would end up with 77.699 cartridges.
That would mean the cartridges of Q4 2020 are 72.261 ...

That changes the perspective of this news to me. This means Q3 was actually better than i thought, and Q4 was not able to grow vs Q3.

regarding the sales price per cartridge:
revenue cartridges H1 2020: 9.584.000 EUR.
cartridges H1 2020: 80.000
price per cartridge: 120

kind regards
JotieP

JotieP 18 januari 2021 19:59

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sigh... al these quarters ... so i will correct myself now:

"now i also notice an error in your Q3 2020.
the cartridges have increased in Q3 2020 with 61% Year on Year. the year to date growth was 27% ... so you should increase the 48.260 cartridges Q3 2020 with 61% to get the cartridges Q4 2020 ... and that would end up with 77.699 cartridges.
That would mean the cartridges of Q4 2020 are 72.261 ..."

should be:

"now i also notice an error in your Q3 2020.
the cartridges have increased in Q3 2020 with 61% Year on Year. the year to date growth was 27% ... so you should increase the 48.260 cartridges of Q3 2019 with 61% to get the cartridges Q3 2020 ... and that would end up with 77.699 cartridges.
That would mean the cartridges of Q4 2020 are 72.261 ..."

Flatlander 19 januari 2021 16:16

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While this is not the Immunexpress PR I was looking for (i.e., COVID Triage) it does show very good results for Sepsis resulting from immunosuppressant Oncology treatments. So Idylla Septicyte Rapid may have a greater synergy with the core oncology offerings than I had originally thought.
FL

Immunexpress to Present SeptiCyte® RAPID Performance Data
at the 50th Critical Care Congress
- Dr. Roy Davis to Present SeptiCyte® RAPID Data from Adult and Pediatric Patients -
- Immunexpress to host a Virtual Booth in the Exhibit Hall at the Congress -
SEATTLE, Jan. 19, 2021 – Immunexpress, Inc., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced the publication of an abstract for a research snapshot presentation to be presented as part of the Society of Critical Care Medicine’s (SCCM) 50th Annual Critical Care Congress being held virtually Jan. 31 through Feb. 12, 2021. The presentation highlights data evaluating the molecular diagnosis of sepsis using SeptiCyte® RAPID.
Details of the presentations are as follows:
Research Snapshot Presentation #: 1275
Title: Performance of SeptiCyte® RAPID in patients with malignancy or treated with antineoplastics or immunosuppressants
Presenter: Roy F. Davis M.D., Ph.D. MHA, Chief Medical Officer at Immunexpress
Session Details: Research Snapshot: Sepsis - Presentation available from January 31 - February 12, 2021
The abstract can be found in the January 2021 issue of Critical Care Medicine here. The virtual presentation can be accessed during the congress of the Critical Care Congress Meeting for registered attendees, who can also talk via live video chat with the authors of the study at the Immunexpress virtual exhibit. A poster of the study will also be posted on www.septicyte.com during the event.
Immunexpress will also be hosting a Virtual Exhibit Hall at the Congress.
About Immunexpress
Immunexpress is a molecular diagnostic company, based out of Seattle, committed to improving outcomes for patients suspected of sepsis. Immunexpress' SeptiCyte® technology can assess a patient's dysregulated immune response by quantifying and analyzing gene expression from whole blood, providing actionable results in about an hour to guide the physician in optimizing patient management decisions. SeptiCyte® RAPID is a lab test for sepsis that combines SeptiCyte® technology with the Biocartis' Idylla™ platform*, empowering clinicians to swiftly differentiate infection positive (sepsis) from infection negative systemic inflammation in patients suspected of sepsis; diagnosing bacterial sepsis, viral sepsis, or fungal infections. This powerful combination of technologies enhances certainty for early sepsis diagnosis, to improve clinical outcomes and lower healthcare costs.
In March 2020, Immunexpress received CE Marking of SeptiCyte® RAPID and announced a commercialization partnership with Biocartis in Europe.
For more information, visit www.immunexpress.com/. Follow Immunexpress on Twitter and LinkedIn.
*Immunexpress is licensed to use the Idylla™ trademark from Biocartis NV.

Maggie.beller@russopartnersllc.com

journals.lww.com/ccmjournal/Citation/...

Flatlander 19 januari 2021 22:12

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Those that have read my comparisons between Cepheid's Gene Expert System and Idylla will be harkened that Cephied has placed more than 30,000 of the units and is solidly profitable (see link). Their initial (2006-2011) trajectory was very similar to that of Idylla (see seeking Alpha cut n paste below). It seems that the inflection point came in 2011 when they launched their HBDC program to enter emerging markets. My point is that there seems to be a ready made market for a low skill, fast MDx platform that will provide actionable results cheaper than NGS systems. Because EGFR mutation incidence is much higher in Asians, China, Korea, Japan, Thailand etc. are likely to offer significant potential for traction.
FL

www.genomeweb.com/business-news/jp-mo...

Cepheid Punished For Unwelcome Variability
Apr. 20, 2012 1:24 PM ETCEPHEID (CPHD)ABT, BDX, HOLX...2 Comments
Stephen Simpson profile picture.
Stephen Simpson
13.44K Followers
Growth investors have an unspoken pact with companies - they'll ignore valuations and keep pushing stocks higher so long as there are no interruptions in the growth trajectory. Unfortunately, Cepheid (NASDAQ:CPHD) is not only a growth stock favorite but a fairly small company as well, and variability and occasional stumbles is just part of the learning curve. While the earnings-related sell-off won't bring these shares anywhere near cheap, business continues to develop along very encouraging lines.

Cepheid Tackled By Its Own Side

Analysts love to talk about the "blocking and tackling" that goes into efficient operations. Unfortunately, the company found itself underneath the pile this quarter.

Revenue was just a touch light, as the total grew 28% from last year and dropped 4% from the fourth quarter. While product revenue was stymied by sluggish system growth (up 4% yoy, down 37% sequentially), reagent revenue rose 38% and 11%, respectively.

Margins is where management really messed up. Product gross margin dropped three and a half points, and significantly higher R&D spending contributed to a sizable miss on the operating line (as a year-ago profit reversed to a loss).

The explanations of what went wrong are credible enough. Higher freight (especially for international sales), higher scrap and lower yields hurt the gross margin line, while costs tied to the CT/NG trial swelled R&D. That's all well and good, but the Street is likely most upset by the lack of warning they got about these developments.

Penetration Good … And About To Get Better?

I suspect some investors will be troubled by the big sequential drop in system sales, but I don't share that concern. Hospitals spent a lot on capital equipment in the fourth quarter of 2011 ("use it or lose it" budgets) and cut back significantly this quarter. That sell-side analysts didn't catch that is on them, not the company. To wit, other companies selling into the hospital capital goods market - including Stryker (NYSE:SYK), Abbott (NYSE:ABT), and Roche (OTCQX:RHHBY) have reported similar trends.

Where it really counts, though, Cepheid seems to be doing well. The company has over 3,000 GeneXpert systems in the field and has grabbed a good slice of the MRSA/c. dif surveillance market. While Quidel (NASDAQ:QDEL) recently got approval for its own c.dif test (to run on AmpliVue), I believe that will be more of a threat to Meridian (NASDAQ:VIVO) than Cepheid.

Looking ahead, I see ample reason to be enthusiastic about Cepheid's future. It looks as though the company is going to price its CT/NG (chlamydia and gonorrhea) test at a price where it will be cost-neutral or cheaper than outsourcing to a reference lab. Many hospitals that already have a GeneXpert for MRSA may then be incentivized to switch to in-house testing.

That's a big advantage for Cepheid when it comes to going up against Gen-Probe (NASDAQ:GPRO), Becton Dickinson (NYSE:BDX), Abbott, and Roche in the CT/NG market, as Cepheid can compete effectively on machine costs (and footprint).

Approaching Emerging Markets From An Interesting Angle

I don't think Cepheid gets quite enough attention for its HBDC program ("High Burden Developing Country"). Under this program, Cepheid sells systems to emerging market countries for a lower price, with the idea of eventually covering the discount with higher usage volume.

So far, demand has been pretty impressive in terms of systems and modules. Moreover, this program could create an opportunity for substantial test revenue in product categories that might not otherwise be so lucrative in developed markets (including tuberculosis and HIV, for instance). At a minimum, this is not a bad way to establish a beachhead in emerging markets.

RUF RTR 25 januari 2021 15:47

3

Biocartis

Biocartis slaagde er vorig jaar in de lagere volumes in de oncologietesten volledig te compenseren door de uitbouw van een infectieziektefranchise in een intensieve zorgomgeving. Dat hielp niet alleen voor de resultaten van vorig jaar, maar maakte het bedrijf ook sterker voor de langere termijn. Dat element, en vooral een geleidelijke normalisatie van het door de coronapandemie onderdrukte volume oncologietesten, moeten in 2021 een extra versnelling kunnen geven aan de verkoopcijfers. Het in 2019 zwaar geschade beleggersvertrouwen is nog niet hersteld, maar dat biedt mogelijkheden voor de geduldige langetermijnbelegger. Bron: Trends Inside Beleggen 22/01/2021

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