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Biocartis « Terug naar discussie overzicht

Biocartis forum geopend

6.444 Posts, Pagina: « 1 2 3 4 5 6 ... 233 234 235 236 237 238 239 240 241 242 243 ... 319 320 321 322 323 » | Laatste

Omlaag ↓

ElTorro 3 september 2021 14:09

CEO spoke of a possible 2 month impact on the supply chain, with normalization afterwards.
If we get confirmation this month that ML2 is up and running again, I see no reason why we should not hold on. In the other scenario it will become problematic.

piloe 3 september 2021 14:33

In the kanaal Z video they mention: "in 2021 H1 we increased our R&D efforts a lot , in the future we will invest at a slower pace.

ElTorro 3 september 2021 15:06

It is simple economics, you can only become profitable if money coming in > the money going out.
Temporarily lowering cost in R&D, together with a cost reduction in the production process, and selling more product at a good price is the way to go. The sooner you reach that point of break even, the better. BCART is reaching that critical point where they have to show they are able to do that.

Flatlander 3 september 2021 20:15

El Torro
A few weeks ago I posted a point Cathy Wood of Ark made about Wrights Law. It dictates that the cost of production of a product should drop by a set amount for each doubling of product output. Wood indicates that the reduction should be 25 to 30% for genomics and automation businesses, I was really looking for evidence of this scaling becomming apparent in BCARTs gross margins as production ramped on ML2. Being from the US it is frustraiting because financial results in the EU are presented semiannually. rather than quarterly. So there are less data points to track this progress. The 9-2 presentation claimed one off reasons resulted in failure to acheive margin improvements (mostly reagent availability restricting ML2 ramp). We are now asked to believe that this problem will be resolved despite the loss of reagents in the fire. We are already seeing investor patience wearing thin. Verrelst need to provide a creditable explanation as to how this will be corrected.

FL

CGCDLR 4 september 2021 12:22

Mogelijke doorbraak in cartridge productie, nieuw vereenvoudigd/kosten efficiënt cartridge ontwerp.
Aanzienlijk lagere productiekosten voor selectie Idylla tests & nieuwe technologie op Idylla voor personalisatie Idylla tests, lagere ontwikkelingstijd/kost .
Cruciale ontwikkeling voor duurzame groei de komende jaren
2021; Cartridges +40%?Waar er eerder een range van 40-60% was.
1/Basic covid testing in USA zal(zoals voorzien)dalen in HJ 2 2021.
2/Groeiseizoen wordt in HJ 1 2022 verwacht.
3/Reagentia op tijd zodanig dat ML2 op tijd kan starten,2 de helft september.
Idylla;300-350 geplaatst,Min 50 milj in kas op voorwaarde dat de verzekering op tijd uitkeert.
Kleine uitstel op vooruitgang menu omdat men die wil lanceren met nieuwe Cartridges.
Waiting feedback FDA MSI test; Verwacht voor komende maanden.
ML3?;Eerst gat ze ML1 &ML2 volledig benutten (capaciteit samen 1,4 miljoen Cartridges)2021 ;320000?
Maw.ML3 is nog niet aan de orde, Verder zou een nieuwe lijn binnen het jaar kunnen functioneren.
Hoe het je bekijkt, het glas is halfvol of halfleeg.,

CGCDLR 4 september 2021 12:24

2/Groeiseizoen=Griepseizoen.

Dr Zoot 6 september 2021 09:42

-- [i]China en Japan -- In China en Japan werd verdere vooruitgang geboekt.
Registratie van het Idylla(TM) instrument in China wordt verwacht tegen eind dit jaar, terwijl registratie van Idylla(TM)
tests ten vroegste eind 2022 zullen volgen voor beide landen.
Voorts verliep in H1 2021 de vooruitgang bij de lokale productie in China voorspoedig; de lokale productie van de eerste
cartridgevolumes nodig voor de lokale registratie van de tests wordt verwacht in H1 2022.

De lokale productie in China wordt volgens dit bericht verwacht in H1 2022: is dat dan niet op die ML3 ? De eerste cartridges dienen voor lokale registratie, wat de logische gang van zaken is.
Dit bericht lijkt mij te bevestigen dat de productielijn in China nu al in opbouw is. Of lees ik dit verkeerd?

Flatlander 6 september 2021 17:27

Dr Zoot

I don't think that you are reading anything wrong. I have the same take away that ML3 is already under construction. Assuming that Wondfo and BCART each kick in 50%, then BCART has already started contributing part of the estimated 10 million required to set up ML3.

They really seem to intentionally underplay the progress reports from China.. I was under the impression that the consoles were already registered or that registration had been waived in China since WondfoCartis sells the units without listing them as RUO, the way the cartridges are designated.

FL

Dr Zoot 6 september 2021 17:54

If Biocartis has already started setting up the ML3 production line (agreed), why is such an important positive story not mentioned more explicitly in their mid-year update? It could certainly help to support the disappointing share price evolution. We are now back at 4.01€.

Flatlander 7 september 2021 01:45

Verrelst indicated a couple years ago. when ML2 was under construction that the next line (ML3) would be faster and cheaper since the designs and fabricators had been identified, However, now they claim that they are contemplating a breakthrough that would significantly lower production costs. If this breakthrough will reduce costs so significantly you would think they would incorporate it into ML3. I think they have done preliminary work on the structure but have not commenced on setting up the portions of the line that could be affected by the changes. All just guesses since they provide few details,

FL

Flatlander 7 september 2021 03:56

The Verrelst interview from a couple years indicated that the 3rd line could be constructed quicker and cheaper than the 2nd line since the designs had been completed and the vendors could recreate the equipment quickly. However, on 9-2 they indicated they were nearing a breakthrough that could significantly lower production costs. It would seem that they would want to incorporate these changes into line ML3. So while we know the timeline that it needs to be operational in H1- 22 so the registration can proceed in China. I think you're right that some discussion was probably warranted, especially since it helps to explain the increased cash burn (I'm assuming BCART pays 50% and Wondfo the other 50%). BCART has steered clear of discussing China in much detail, either because they don't want to box in government regulators or because they don't want to tip off competition.

FL

Phoene 7 september 2021 18:12

quote:
Dr Zoot schreef op 6 september 2021 09:42:
-- [i]China en Japan -- In China en Japan werd verdere vooruitgang geboekt.
Registratie van het Idylla(TM) instrument in China wordt verwacht tegen eind dit jaar, terwijl registratie van Idylla(TM)
tests ten vroegste eind 2022 zullen volgen voor beide landen.
Voorts verliep in H1 2021 de vooruitgang bij de lokale productie in China voorspoedig; de lokale productie van de eerste
cartridgevolumes nodig voor de lokale registratie van de tests wordt verwacht in H1 2022.

De lokale productie in China wordt volgens dit bericht verwacht in H1 2022: is dat dan niet op die ML3 ? De eerste cartridges dienen voor lokale registratie, wat de logische gang van zaken is.
Dit bericht lijkt mij te bevestigen dat de productielijn in China nu al in opbouw is. Of lees ik dit verkeerd?

Kunnen ze geen cartridges maken/samenstellen in een labo ofzo zonder een productielijn? Zou mij sterk verbazen dat je een productielijn bouwt zonder over te communiceren... De eerste cartridges die ze hier maakten zullen toch ook niet direct op een productielijn gemaakt zijn.

Dr Zoot 7 september 2021 21:07

De cartidges geproduceerd in China zijn m.i. exact dezelfde als deze die nu geproduceerd worden in België, dus hiervoor moet je geen extra productielijn bouwen in China. Een lokale productielijn in China is m.i. een noodzakelijke voorwaarde om daar testen gecertifieerd te krijgen voor vermarkting op de Chinese markt. Enkel cartridges geproduceerd op een lokaal gecertificeerde productielijn worden toegelaten. Maar vermoedelijk wordt het nadien wel mogelijk in China geproduceerde cartidges elders in de wereld te gebruiken. De kans is groot dat die een stuk goedkoper zullen zijn dan in Belgie geproduceerde exemplaren (met stevige premies voor nacht- en weekend werk, wat vermoedelijk in China niet geldt)

Echter, ik heb grote verwachtingen van de aangekondigde "simplified cost effective manufacturing method under evaluation): hierbij worden in de geproduceerde cartridges enkel de generieke reagentia vloeistoffen toegevoegd (van toepassing voor alle Idylla gebaseerde tests) en de test specifieke reagentia nog niet. Die worden door de klant zelf toegevoegd al naargelang de test die zij uitvoeren. Dat betekent een enorme besparing in warehousing voor Biocartis: immers, in het oude systeem moet je per type test op basis van een sales forecast voorraad cartridges produceren per test, vermoedelijk met een beperkte houdbaarheid per test type. Nu worden alle cartridges identiek (enkel met de basis reagentia) en allles compatiebel met bestaande installed base equipment.

Flatlander 8 september 2021 00:50

Dr Zoot
The system you describe sounds interesting but I'll be curious how the finishing reagents are added without compromising the sealed, free from DNA cross contamination that is presently claimed. Finding a cheaper way to manufacture cartridges seems critical to BCARTs long term survival.

FL

Flatlander 9 september 2021 15:34

One more reason for the decreased gross margins during the 1st half.

Although BCART did not discuss it, the sales revenue from the US was very low (about the same as the UK). The relative market mix with the US (a high priced market) comprising a lower percentage of the sales undoubtedly played a large role in the margin erosion. They attributed it to hospital budgets constrained by COVID, I think this is incorrect. The government has flooded the public sector in the US with liquidity. As I've said before, the RUO probably comprises less than 10% of the hospitals in the US, Most RUO environments are associated with university health complexes or are reliant on grad student staffing of labs. So, when almost all of your products are designated RUO, it is a huge constraint, Most universities in the US were under COVID lockdown and teaching remotely during the 1st half. Therefore, many research assistants were not in the labs, so much of the RUO market was non-existent.or severely limited.

Most universities have reopened and research labs should be functional in the 2nd half. So I think the numbers will look better, assuming the fire constrained supply can be re-established. More importantly, I believe this situation drives home the importance of the registrations. MSI and Septicyte are pending FDA approval. These approvals any many other assay approvals are necessary to open the use of Idylla to the wider universe of facilities outside of the RUO setting. The increase in Idylla use in the EU where the number of IVD registrations is greatest demonstrate that labs can use the Idylla flexibility to meet testing demands since they promote distancing etc. Due to the RUO restriction, Idylla cannot be used in this manner in the US.

FL

ElTorro 9 september 2021 18:34

Indeed FL, we are still awaiting the approvals in US... I do not understand why this is taking so long.

CGCDLR 9 september 2021 21:16

Sepsis September;het is eens tijd dat die test wordt goedgekeurd. "Sepsis takes a live every 2 minutes".
Waar wachten ze eigenlijk op?

Dr Zoot 9 september 2021 21:37

FL

To be honest, I don't have the answer to your question regarding the additional contamination risk caused by off-line filling of the bio-marker specific reagents.
I guess a peristaltic pump to fill the pre-sealed empty slot in the cartridge should go a long way.
Interestingly, Biocartis doesn't only mentions cost savings, but also shorter development time as one of the advantages.
(Simplified certification process without re-certification of generic components for the sample preparation and biomarker detection? not sure)

The text reads:

The VLAIO grant is intended to support the ongoing development of a new Idylla™ technology, which will enable the off-line customization of the Idylla™ cartridge. The first generation Idylla™ cartridges contain not only the generic components for sample preparation and biomarker detection, but also the biomarker-specific reagents. The next generation Idylla™ cartridges on the other hand would only contain the generic components for sample preparation and biomarker detection, and would be made biomarker-specific through the addition by the user of a ready-to-use mixture containing biomarker-specific reagents. This new Idylla™ technology would be fully compatible with the current Idylla™ cartridge manufacturing lines and installed base, and is expected to further reduce the Idylla™ assay development time and cost.

Flatlander 9 september 2021 23:48

Dr Zoot,

I think it is a concern but is definitely not insurmountable. Labs are used to procedures that minimize or eliminate potential for cross contamination. My guess is that the assay specific reagents will be introduced through a kit containing pre-filled syringes or similar device. The reagents currently used are in a freeze dried state, largely because they have longer shelf life, so there may be a constraint that the assay must be run in a relatively short time following the addition of the assay specific reagents.

Hopefully, there won't be any IVD registration approval issues, for assays that already have full IVD approval.

Regards FL

Gijpie 10 september 2021 12:48

Flat I think your right about the RUO , it’s a big problem for penetration in the US . But to my understanding for the COVID test there were no restrictions. So again with uncountable PCR test performed worldwide they suceed in not getting a slice of that pie. They need urgently a commercial service that starts selling the systems , if you have that kind of technological advantage and after the pandemic is gone they can be used in oncologie. Finally for those who think the new construction of the cassettes would be the holy grale, the current cassettes are not yet FDA approved after how many years so excuse me to have a little doubt .

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