Biocartis forum geopend

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brightlight
0
FL

Thanks for the clarification. Very interesting, as always. I am wondering, can you quantify the impact on sales of the market introduction of Septicyte RAPID in Europe? How important is it, is this one of the killer apps you have long been talking about?

BL
Flatlander
0
BL

As far as I can tell there are probably at least 10 rapid point of care SARs-COV-2 test systems on the market with EUA's in the US. I'm less certain about the status of the EU approvals. The tests fall into two categories viral antigen (quick but less accurate) and nucleic acid/PCR (take longer but more accurate). Idylla will never be a high volume system but I think it could fill the following two niche markets:

1) As a pre-surgical precaution to protect medical staff. Currently most colonoscopy, breast lumpectomy, lung phlebotomy, etc procedures are asking patients to get a COVID test 48 to 72 hours prior to the procedure. This takes the chance that the patient does not become infected after the testing but before the procedure. I can see a case for using Idylla in a hospital setting before letting the patient into the room where the procedures are conducted. I don't know that a lot of new consoles would be sold for this purpose but it seemingly be a welcome offering for physicians that are already using Idylla in a POC environment. The number of cartridges used for each of these existing units could easily triple or quadruple under this scenario.

2) the second application is the one we have discussed already. Use of the COVID test in combination with Septicyte Rapid in an Emergency Room setting for triaging patients. I think this is a large market but is dependent on the validation demonstration. In the EU, it is already available. Hopefully, some of the users will author studies on the use of Septicyte Rapid that increase the traction of the test. Some of the very limited data presented during the ImmunExpress SCCM presentation suggested that the test could provide a early indication of patients likely to have an immune response likely to develop into sepsis. Assuming the validation shows considerable utility then the product will have a strong market. My guess is that during a normal year adoption traction would probably be slow, maybe a hundred additional consoles sold per year with maybe a 20% growth rate as practitioners share their experiences. During a pandemic these rates could be greatly accelerated as ER's look for ways to more efficiently utilize resources. Immunexpress showed a slide during one of their presentations that suggested that the more accurate diagnosis of ER patients likely to develop sepsis could potentially save several thousand dollars of cost per patient over a typical (if there is a typical) COVID hospitalization. As such, the payback to the hospital could be very rapid. If the validation study works out or a landmark user paper/positive large hospital study release then the combination Septicyte/COVID test could unlock a large market with accelerating sales. Under this scenario, I could see a couple hundred additional console sales in the next year (this assumes that some of the larger partners JnJ etc. co-promote Idylla use). Because these would be POC rather than RUO applications I would think the cartridge utilization rates would be much higher than anything we have seen previously (say 700 to 1500 tests per year per console). So under this scenario, maybe we see roughly a doubling of the cartridge sales.

God willing, the COVID market should dissipate in the 2nd half of 2021 as the percentage of the population vaccinated increases toward the herd immunity levels. After that the growth trajectory would probably look like a more typical year. Probably not the Killer App unless the market persists at accelerated rates for several years. I'm hopeful this does not become the case!

I still think the use of EGFR assays in Asian countries with high incidence of the mutation and limited placement of NGS has the makings of a great market assuming a strong partner like AZN co-promotes Idylla. The question marks are when will Idylla be approved for full IVD use and what will the reimbursement rates be? ESMO and other conferences are emphasizing faster TAT of MDx data for NSCLC treatment. Some of the papers are emphasizing that this MDx data is key to decision making during the COVID pandemic. Fast TAT MDx data is integral determining whether the patient should be treated via chemo, oral drug regimes, etc. Idylla is well situated for this niche market. EGFR and the Fusion panel is more likely a killer Ap in my mind.

Once again, a lot of conjecture.

FL
Pommeke
0
quote:

Ivel schreef op 3 september 2020 14:05:


[...]
Kan je mij 1 biotechbedrijf noemen die niet veel cashburn heeft?
Ontplooiing van dergelijke medische apparatuur en bijbehoren duurt jaren eer het winstgevend wordt.


Pharming group (AMX)
:)
joe123
0
Resem nieuwe vacatures nl.
Operatoren voor 2 ploegen systeem(plus vrijwillig op zaterdag).
Lab operations Manager.
Head of Risk and Complience.
Er wordt daar niet stilgezeten in Mechelen. Vooral de gezochte operatoren voor 2ploegenstelsel en zaterdagwerk geeft mij een hoopgevend gevoel.
brightlight
0
quote:

Flatlander schreef op 22 september 2020 17:30:


BL

... the combination Septicyte/COVID test could unlock a large market with accelerating sales. Under this scenario, I could see a couple hundred additional console sales in the next year (this assumes that some of the larger partners JnJ etc. co-promote Idylla use). Because these would be POC rather than RUO applications I would think the cartridge utilization rates would be much higher than anything we have seen previously (say 700 to 1500 tests per year per console). So under this scenario, maybe we see roughly a doubling of the cartridge sales ...

FL

FL

Bcart is clearly expecting a lot from the Septicyte/COVID test. Attached is a table with the quarterly cartridge sales data which I compiled recently. The quarterly numbers are not provided by Bcart, but if you go back long enough through the quarterly updates and half and full year financial reports, you can extrapolate the exact numbers. There are a number of key take-aways:
1. up until the end of 2018 there was a nice sequential quarterly (high) growth rate in the numbers,
2. we can clearly point the finger at the Fisher and COVID19 problems (in red) for the slowing of sales, but once Covid is resolved, there is no reason why high sequential growth cannot resume in the (near?) future, and even with Covid...
3. Bcart is clearly expecting a lot from the Septicyte/COVID test as can be seen in the numbers (Q4'20). Verrelst said in the conference call that he expects this year only a 12% YonY quarterly growth from the base (oncology) business. So in order to get to a projected yearly total of 228.000, no less than 32.000 Covid cartridges will have to be sold in Q4 alone. Of course, Verrelst may have his reasons for underestimating base business and overestimating the Covid test sales,
4. assuming sequential growth will resume, or assuming the Q4 sales number will just carry on into next year (as projected in the table), with the Covid test picking up the slack until the base business resumes its normal growth path, Bcart may well be back on track for decent growth.

At first glance the Covid test sales number seems unusually high, so maybe there is a mistake in my numbers, but I don't see it. Anyway, I find the information sufficiently interesting for it to be shared.

BL
Bijlage:
Flatlander
0
BL

I believe 393,000 cartridges in 2021 is achievable given the new product mix that will be introduced. Oncology MDx demand is anticipated to be at an all time high next year as the pandemic delayed procedures result in more serious disease. I see EGFR gaining a lot of traction in 2021. It will be a bit of a sales challenge with the combined infectious disease and oncology focus, That is why I think the initial sales of the COVID test will be in the settlings where Idylla is already deployed.

The geographic access to the higher reimbursement rate markets (US, Japan, UAE, etc) will be critical in moving the needle toward cash flow positive.

Regards FL
Flatlander
1
Ilumina Acquisition of Grail is perplexing.

Illumina sells NGS sequencing equipment to a variety of labs and content developers (Guardant, Archer & many others). Why would they buy a content provider (primarily liquid biopsy)? Will this move drive more content developers to migrate where possible to an alternate platform such as Fisher Scientific NGS equipment? While Illumina has had a long history with Grail, my guess is that Illumina got serious about the acquisition road when Fisher was going to acquire Qiagen. I can't help asking whether this acquisition will trigger additional consolidation of NGS providers? The industry is growing fast an is extremely fragmented.

One of the things that initially attracted me to BCART is that they control their Idylla platform and can build out their own content as well as partner sponsored content. Grail is taking direct aim at EXAS precision oncology unit (formerly GHDX plus a few other additions). I believe EXAS would be well served by differentiating from Grail's offerings (when they hit the market) by moving into the point of care environment by launching OncoType on Idylla. If they do not proceed that way they will likely find themselves one of many lab based MDx tests. The TailorX study advantage will likely dissipate with time as other assays become more accurate.

FL
voda
0
PERSBERICHT: Persbericht Biocartis Group NV: Resultaten van de buitengewone algemene aandeelhoudersvergadering gehouden op 25 september 2020

FONDS KOERS VERSCHIL VERSCHIL % BEURS
Biocartis NV
4,50 -0,05 -1,10 % Euronext Brussel

PERSBERICHT: GEREGLEMENTEERDE INFORMATIE

25 september 2020, 17:40 CEST

Resultaten van de buitengewone algemene aandeelhoudersvergadering
gehouden op 25 september 2020

Mechelen, België, 25 september 2020 -- Biocartis Group NV (de
'Vennootschap' of 'Biocartis'), een innovatief bedrijf in de moleculaire
diagnostiek (Euronext Brussels: BCART), hield vandaag zijn buitengewone
algemene aandeelhoudersvergadering. De aandeelhouders keurden alle
punten op de agenda van de buitengewone algemene
aandeelhoudersvergadering goed.

Alle documenten betreffende de aandeelhoudersvergadering kunnen
geraadpleegd worden op de website
www.globenewswire.com/Tracker?data=U1...
van de Vennootschap.

--- EINDE ---

Meer informatie:

Renate Degrave

Hoofd Corporate Communications & Investor Relations Biocartis

e-mail
www.globenewswire.com/Tracker?data=cP...
rdegrave@biocartis.com

tel +32 15 631 729

gsm +32 471 53 60 64
Flatlander
1
You'll have to excuse me. In 25 years of investing in Nasdaq and NYSE listed companies I've never seen a similar Share Premium Capital redistribution. They did not post the material in English, here is the translation of some of the pertinent parts I found in the meeting materials release. So if my read is right, is this share premium adjustment done to 1) reduce 2019 tax liability? Did Belgium extend 2019 tax due dates appreciably due to Coronavirus? and 2) Set the 2020 financials on better footing? Anyone want to explain or hypothesize on the reasoning.

"please refer to the summons to the extraordinary general shareholders' meeting. EXTRAORDINARY GENERAL MEETING Agenda and proposals to conclude: The agenda and proposals to conclude the Extraordinary General Shareholders' Meeting of the Company, which may, where appropriate, be amended at the meeting on behalf of the Board of Directors are as follows: 1. Capital increase by incorporation of issuance premiums followed by capital reduction to discharge losses Notes: This item on the agenda concerns the proposal that the extraordinary general shareholders' meeting decides to increase the Company's capital without issuing new and equity by incorporating part of the issue premium, and to reduce the company's capital immediately after the aforementioned capital increase in accordance with Article 7:210 of the Code of Companies and Associations through the incorporation of losses incurred as shown by the single financial statements for the financial year ended December 31, 2019. Proposal to conclude The General Meeting decides to increase (i) the Company's capital by a sum of one hundred and four million seventy thousand five hundred and ninety-five cents (€ 104,070.59 4.45) without issuance of new shares and by incorporation of part of the issue premium (as shown by the single financial statements for the financial year ended December 31, 2019) in the Company's capital , and (ii) to reduce the company's capital immediately after the aforementioned capital increase in accordance with Article 7:210 of the Code of Companies and Associations with an amount of one hundred and four million seventy thousand five hundred and ninety-four cents (€ 104.07 0.594.45) to bring it back to five hundred and sixty-three thousand eight hundred and eighty-eight cents Extraordinary General Shareholders' Meeting of 25 September 2020 Page 2 Notes (€ 563,820.88) , by means of the inclusion of losses for the previous amount of one hundred and four million seventy thousand five hundred and ninety-five cents forty-five cents (€ 104,070,594.45), as shown by the single annual accounts for the financial year ended 31 December 2019. The aforementioned capital reduction (i) will first be allocated to all amounts that do not qualify as tax-filled (or equivalent) capital, (ii) will take place without the destruction of the Company's existing shares, and (iii) will be borne by each of the Company's existing shares in the same manner. 2. Submitting the Executive Board's special report pursuant to Article 7:199 of the Code of Companies and Associations on the proposal to renew the authorised capital Explanatory Note: This item on the agenda concerns the presentation, knowledge and discussion of the Governing Council's special report in accordance with Article 7:199 of the Code of Companies and Associations on the proposal to renew the powers granted to the Governing Council under the authorized capital. A copy of this document is available on the Company's website and at the Company's headquarters."
joe123
1
quote:

Hennie76 schreef op 27 september 2020 09:13:


vimeo.com/460354197/cec0521ebd


Een groot compliment voor cfo Jean Marc Roelandt voor deze duidelijke kwaliteitsvolle uiteenzetting.
Dit geeft een mens vertouwen.
GoedeDag
0
quote:

Flatlander schreef op 26 september 2020 18:39:


You'll have to excuse me. In 25 years of investing in Nasdaq and NYSE listed companies I've never seen a similar Share Premium Capital redistribution. They did not post the material in English, here is the translation of some of the pertinent parts I found in the meeting materials release. So if my read is right, is this share premium adjustment done to 1) reduce 2019 tax liability? Did Belgium extend 2019 tax due dates appreciably due to Coronavirus? and 2) Set the 2020 financials on better footing? Anyone want to explain or hypothesize on the reasoning.

"please refer to the summons to the extraordinary general shareholders' meeting. EXTRAORDINARY GENERAL MEETING Agenda and proposals to conclude: The agenda and proposals to conclude the Extraordinary General Shareholders' Meeting of the Company, which may, where appropriate, be amended at the meeting on behalf of the Board of Directors are as follows: 1. Capital increase by incorporation of issuance premiums followed by capital reduction to discharge losses Notes: This item on the agenda concerns the proposal that the extraordinary general shareholders' meeting decides to increase the Company's capital without issuing new and equity by incorporating part of the issue premium, and to reduce the company's capital immediately after the aforementioned capital increase in accordance with Article 7:210 of the Code of Companies and Associations through the incorporation of losses incurred as shown by the single financial statements for the financial year ended December 31, 2019. Proposal to conclude The General Meeting decides to increase (i) the Company's capital by a sum of one hundred and four million seventy thousand five hundred and ninety-five cents (€ 104,070.59 4.45) without issuance of new shares and by incorporation of part of the issue premium (as shown by the single financial statements for the financial year ended December 31, 2019) in the Company's capital , and (ii) to reduce the company's capital immediately after the aforementioned capital increase in accordance with Article 7:210 of the Code of Companies and Associations with an amount of one hundred and four million seventy thousand five hundred and ninety-four cents (€ 104.07 0.594.45) to bring it back to five hundred and sixty-three thousand eight hundred and eighty-eight cents Extraordinary General Shareholders' Meeting of 25 September 2020 Page 2 Notes (€ 563,820.88) , by means of the inclusion of losses for the previous amount of one hundred and four million seventy thousand five hundred and ninety-five cents forty-five cents (€ 104,070,594.45), as shown by the single annual accounts for the financial year ended 31 December 2019. The aforementioned capital reduction (i) will first be allocated to all amounts that do not qualify as tax-filled (or equivalent) capital, (ii) will take place without the destruction of the Company's existing shares, and (iii) will be borne by each of the Company's existing shares in the same manner. 2. Submitting the Executive Board's special report pursuant to Article 7:199 of the Code of Companies and Associations on the proposal to renew the authorised capital Explanatory Note: This item on the agenda concerns the presentation, knowledge and discussion of the Governing Council's special report in accordance with Article 7:199 of the Code of Companies and Associations on the proposal to renew the powers granted to the Governing Council under the authorized capital. A copy of this document is available on the Company's website and at the Company's headquarters."


I asked myself and the rest of this site the same question when this shareholder meeting was made public and no one seems to know.

Looks like they found someone/something to pour in fresh 'starter' capital and then immediately erase it with the debt.

Which would serve nicely to clean up their balance sheet and no more interest/monthly costs dragging down their financial numbers. Someone in Biocartis has deep pockets.
DRTVR
0
Flatlander
0
Novacyt is a great contrast to BCART they are small nimble and innovative. They get product to the market very quickly. It has made up for my BCART losses. I have thought that they should buy BCART and use their technology to greatly accelerate Idylla offerings.

I now see that the BCART presentations are estimating China and Japan registrations at the end of 2021. The Amgen US registration filing is delayed due to COVID. The EUA's for COVID are even taken longer than I expected.

I still maintain that BCART could be a great long term holding if they can access the POC market. They are apparently doing this with some assays in the EU, South America and Canada. If the Webinar I posted a few weeks ago is right, COVID will be a catalyst to move MDx to the POC environment (or at least out of centralized labs). So I'm on the hook for another year looking for the long awaited inflection point!

FL
Flatlander
0
GoedeDag

I was disappointed that the meeting materials were only released in Dutch, The google document translate took a long time and totally lost all formatting. One 28 page paragraph. I lost patience and did not make it all the way thru the document. I must admit that there are provisions in the Belgium market that I do not totally understand.

I have done well with MDx investments. BCART is my sole loser, thus far. I constantly look for evidence that I might be missing something. Thus far, other than some delayed projects I've yet to find conclusive evidence that the POC cancer MDx thesis is wrong. While NGS turnaround time was coming down before COVID, Idylla still had a nice TAT advantage and a cost advantage. I think the most likely competition is smaller cheaper NGS units placed closer to the patient. This battle is ongoing and Idylla could use more content to drive adoption.

I guess we need to look toward the 3rd Qtr update/capital markets day in November fot updates on these fronts..

FL
DRTVR
0
quote:

Flatlander schreef op 29 september 2020 15:33:


GoedeDag

I was disappointed that the meeting materials were only released in Dutch, The google document translate took a long time and totally lost all formatting. One 28 page paragraph. I lost patience and did not make it all the way thru the document. I must admit that there are provisions in the Belgium market that I do not totally understand.

I have done well with MDx investments. BCART is my sole loser, thus far. I constantly look for evidence that I might be missing something. Thus far, other than some delayed projects I've yet to find conclusive evidence that the POC cancer MDx thesis is wrong. While NGS turnaround time was coming down before COVID, Idylla still had a nice TAT advantage and a cost advantage. I think the most likely competition is smaller cheaper NGS units placed closer to the patient. This battle is ongoing and Idylla could use more content to drive adoption.

I guess we need to look toward the 3rd Qtr update/capital markets day in November fot updates on these fronts..

FL


Gisteren gekocht en voormiddag verkocht, goede zaak gedaan, goede raad is goud waard, BC blijft zeker in mijn portefeuille zitten,
groeten.
Flatlander
0
I trimmed a little on the 25% runup this morning but I'm still holding the majority of my position. They are minting cash, eliminated all debt and are building a nice war chest. Their Primer Design group is very agile.

FL
ElTorro
0
Phoene
0
Voor de mensen die klant zijn bij Bolero.

Beste klant,

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Mis dit unieke event niet:

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Flatlander
1
Bought in on ALNOV on July 13 at 2.80. The price tanked that day on a great earnings report. I remember buying in thinking that people are selling the news way too early since the pandemic and COVID testing were only in the initial stages. That said, Novacyt had already run a fair amount before I bought in, so I'm sure the seller thought it was time to bank their gain.

Either way I'm playing with the houses money now!

FL
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Vertraagd 27 nov 2020 17:35
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