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[verwijderd] 16 januari 2020 16:45

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quote:
Flatlander schreef op 16 januari 2020 16:17:
On 16 January 2020, Biocartis’ CEO Herman Verrelst will present at the
38th Annual J.P. Morgan Healthcare conference in San Francisco (US) at 10:30AM PST

This presentation and the Q and A are over by now, anyone know what was said? Hopefully, IR puts up a summary or a webcast link shortly. I imagine that JPM requires some delay to protect the attendees that paid to attend the conference.

FL

I think the presentation will only start in about 3 hours and cannot be followed via a webcast.

Perhaps we can hear something through the media there. Otherwise preferably via a press release from Biocartis! ;-)

Flatlander 16 januari 2020 16:54

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Reply you are right. Stupid on my part.

FL

[verwijderd] 16 januari 2020 17:01

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quote:
Flatlander schreef op 16 januari 2020 16:54:
Reply you are right. Stupid on my part.

FL

No worries. We are on the same team! ;-)

brightlight 16 januari 2020 17:31

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FL
I would like to elaborate on RUO a bit. I believe the big growth driver for 2020, which probably already has started, will be the roll out of Idylla in Japan, initially on an RUO basis. I am wondering if RUO will make a big difference in cartridges sold per console on these newly rolled out Japanese Idyllas, as opposed to cartridges sold in "fully approved markets". As you (FL) have already elaborated upon in earlier posts, RUO makes a big difference as to what is allowed on the advertizing front, but I wonder if it makes a difference in the cartridges sold per console. In the Japan context, advertising initially doesn't play a part because Nichirei will start rolling out at their 2000 customer labs. What is your take on this?
BL

[verwijderd] 16 januari 2020 17:34

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I wonder if we can follow the presentation here tonight. Scroll down and look at "Updates".

www.linkedin.com/company/biocartis

Gijpie 16 januari 2020 17:40

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@ brightlight if you look at the Nichirei website i don’t see any indication of the Idylla lab this strikes my as strange this can be due to the RUO restrictions but even a press release of clearance for the japanese market is not mentioned

Flatlander 16 januari 2020 18:00

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BL

I don't know the Japanese market well enough to really opine on what the sales figures would look like under the RUO market scenario vs. full diagnostic approval. So what you age getting is more or less a guess. It seems to me that the RUO markets are largely limited to 1) qualifying patients for a CDx or other studies - similar to Covance 2) use in expanding registration approval of the assay content 3) use for validating or checking replication ability of other methods (i.e., especially in the case of marginal samples) 4) miscellaneous research/publication studies. I still think in every market that diagnostic use is likely to outweigh these combined RUO uses, especially as products become more established. But given how early BCART is on the growth curve 2000 or even 500 Nichirei Labs conducting RUO validation studies would still be a huge boost. It is hugely important for BCART to quickly expand the RUO community. Supporting publications and studies coming out of this user community is extremely important for expanded adoption. BCARTs slide show emphasizes this publication groundswell. I can tell you that early on at GHDX there were many of these types of studies before the groundbreaking NEJM TailorX study that changed everything. These landmark studies tend to be large thousands or tens of thousands of data points. That can represent a lot of RUO use but in my opinion still a drop in the bucket compared to the diagnostic market.

FL

brightlight 16 januari 2020 18:04

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quote:
Gijpie schreef op 16 januari 2020 17:40:
@ brightlight if you look at the Nichirei website i don’t see any indication of the Idylla lab this strikes my as strange this can be due to the RUO restrictions but even a press release of clearance for the japanese market is not mentioned

Ik heb me dat ook al afgevraagd. Kan inderdaad met RUO restricties te maken hebben. Meest logische verklaring.
Er was misschien geen persbericht van de Japanse kant (heb er niet naar gezocht), maar het persbericht van Bcart was duidelijk: de marktintroductie is een feit.

Persbericht Biocartis Group NV: NICHIREI BIOSCIENCES START MARKTINTRODUCTIE VAN IDYLLA™ PLATFORM IN JAPAN

November 14, 2019 01:00 ET | Source: Biocartis NV

PERSBERICHT: 14 november 2019, 07:00 CET / 14:00 JST

NICHIREI BIOSCIENCES START MARKTINTRODUCTIE VAN IDYLLA™ PLATFORM IN JAPAN

Mechelen, België, 14 november 2019 – Biocartis Group NV (de ‘Vennootschap’ of ‘Biocartis’), een innovatief bedrijf in de moleculaire diagnostiek (Euronext Brussels: BCART), maakt vandaag bekend dat zijn distributiepartner voor de Japanse markt, Nichirei Biosciences Inc. (een toonaangevende leverancier van biologische en diagnostische producten in Japan, hierna 'Nichirei Bio.'), de registratie van het Idylla™ Instrument en de Idylla™ Console bij het ‘Pharmaceuticals and Medical Devices Agency’ (PMDA) in Japan voltooid heeft in oktober 2019. Dit is een belangrijke mijlpaal voor de commerciële strategie in Japan, aangezien Nichirei Bio. voortaan het Idylla™ platform in combinatie met Idylla™ RUO1 tests zal kunnen aanbieden aan lokale pathologielaboratoria in Japan.

Het Idylla™ platform zal naar verwachting formeel geïntroduceerd worden door Nichirei Bio. tijdens de 58e jaarvergadering van de ‘Japanese Society of Clinical Cytology’ in Okayama op 16 november 2019. Parallel met de initiële uitrol van het Idylla™ platform werken beide partners verder aan de IVD-registratievoorbereidingen voor de Idylla™ tests in Japan.
BL

brightlight 16 januari 2020 18:44

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quote:
Flatlander schreef op 16 januari 2020 18:00:
BL

I don't know the Japanese market well enough to really opine on what the sales figures would look like under the RUO market scenario vs. full diagnostic approval. So what you age getting is more or less a guess. It seems to me that the RUO markets are largely limited to 1) qualifying patients for a CDx or other studies - similar to Covance 2) use in expanding registration approval of the assay content 3) use for validating or checking replication ability of other methods (i.e., especially in the case of marginal samples) 4) miscellaneous research/publication studies. I still think in every market that diagnostic use is likely to outweigh these combined RUO uses, especially as products become more established. But given how early BCART is on the growth curve 2000 or even 500 Nichirei Labs conducting RUO validation studies would still be a huge boost. It is hugely important for BCART to quickly expand the RUO community. Supporting publications and studies coming out of this user community is extremely important for expanded adoption. BCARTs slide show emphasizes this publication groundswell. I can tell you that early on at GHDX there were many of these types of studies before the groundbreaking NEJM TailorX study that changed everything. These landmark studies tend to be large thousands or tens of thousands of data points. That can represent a lot of RUO use but in my opinion still a drop in the bucket compared to the diagnostic market.

FL

FL,
Since the 37% pick-up (representing 31000 cartridges) in cartridge sales (H2 versus H1) was attributed by most analysts to a pick-up of sales in the U.S., I derive from that that there is not that much difference between RUO cartridge consumption and normal consumption. I have no other explanation:

"Het herstel is volgens Van Steenhuyse te danken aan de heropleving van de Amerikaanse markt in het tweede jaarhelft van 2019. De analist schat de groei van cartridgevolume op 37 procent in het tweede semester.
Aangezien de herziene doelstellingen van Biocartis voor de eerste helft van 2019 destijds ingegeven waren door de teleurstellende prestaties in de VS, is Van Steenhuyse van mening dat de groei in het eerste jaarhelft gedragen wordt door de Europese regio en de rest van de wereld."

Although I am not sure we can 100% rely on these analyst's explanations, it sure seems cartridge consumption in an RUO environment is quite considerable, which bodes well for the Japan ramp-up.
BL

brightlight 16 januari 2020 19:53

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Slides of today's presentation are available on jpmorgan.metameetings.net/events/hc20...
No new announcements in the slides as far as I can tell.
BL

[verwijderd] 16 januari 2020 20:11

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quote:
brightlight schreef op 16 januari 2020 19:53:
Slides of today's presentation are available on jpmorgan.metameetings.net/events/hc20...
No new announcements in the slides as far as I can tell.
BL

Lijkt inderdaad de meest recente "standaard" Corporate presentation te betreffen.
Het eventuele "nieuws" moet dus vanuit de verdere toelichting door CEO Herman Verrelst zelf komen of vanuit de Q&A sessie met de aanwezige toehoorders na afloop van de presentatie.
Ik hoop morgen sowieso ergens een verslag terug te lezen van de aanwezige media aldaar. "De Tijd" uit Vlaanderen doet met regelmaat verslag over de Belgische Biotech en Farma bedrijven. En wie weet doet een succesvolle conferentieweek de beurskoers vanaf morgen ook weer verder opleven.

Flatlander 16 januari 2020 21:47

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Most of us would agree that BCART's Idylla is a disruptive technology in that it reduces the time and cost for MDx analyses. One thought that I have quite frequently is whether an industry can be disrupted before it is ready? Most small health care settings have not even started using MDx data yet, so they are not in a position to appreciate the streamlined sample to results product. There is a human tendency to follow the herd. Right now the herd in the U.S. is promoting expensive NGS MDx. However, as we do every 4 years, Americans are looking at our health care system and wondering why we spend more than any other country but have outcomes that are in the middle of the pack. I think the answer is simple, we are sold expensive solutions by those with a vested interest. Eventually, it will become apparent that we cannot consistently spend 17% of GDP (twice other Industrialized countries) with results that are no better than some emerging market countries. I have to believe at some point that this will lead us to a more European model. We have seen this to some extent in in Biogenerics and Biosimilar Drug adoption. I think a more streamlines system for implementing MDx and CDx will follow. The big question is how quickly.

BCART has had a number of publications by research oriented institutions Sloan Kettering, Dartmouth, etc. Perhaps a different focus on large Hospitals that are known for being cost cutting leaders might be more productive. I see that Kaiser Permanente has reviewed BCART product. I'd love to see a publication out of Kaiser documenting the relative cost advantages of Idylla. A lot of hospitals and clinics in the US look to Kaiser to point out ways to reduce costs.
FL

[verwijderd] 17 januari 2020 09:28

1

JP Morgan Healthcare Day 4: Biocartis, Oxford Immunotec

Jan 16, 2020 | Leo O'Connor

SAN FRANCISCO – The 38th annual JP Morgan Healthcare Conference wrapped up on Thursday here with a handful of diagnostics and biotech companies presenting. Below are brief reports on the presentations and breakout sessions of Biocartis and Oxford Immunotec covered by our reporter at the conference. For our previous coverage this week, please see this page on our site.

Biocartis

Biocartis CEO Herman Verrelst said his firm is well positioned through continued menu expansion and new partnerships to achieve "substantial volume growth" over the next few years.

The Belgium-based molecular diagnostic test developer placed 337 new instruments in 2019, well within its guidance, he noted.

As of Dec, 31, the installed base of its Idylla molecular diagnostic instruments reached 1,310, and the number of cartridge sales hit 175,000, representing a year-over-year increase of 32 percent.

In 2019, Verrelst noted, the firm received CE-IVD marking for and launched the Idylla MSI Test and launched the Idylla ctEGFR Mutation Assay on a research-use-only basis. The company also announced a collaboration agreement with Bristol-Myers Squibb focused on MSI testing and inked a commercialization agreement with Kite, a Gilead Sciences subsidiary, aimed at development of molecular-based assays on the Idylla platform to support Kite's therapies.

The agreement with Kite is part of Biocartis' ongoing plans to expand its presence in oncology with a series of immunotherapy and liquid biopsy assays on the Idylla platform, Verrelst said.

He said that with a high double-digit growth rate each year, oncology is the fastest growing segment of a global MDx market worth $6.5 billion.

Biocartis' partnership with Genomic Health will add high value genomic signatures to its menu, and partnerships with pharma giants, such as Amgen, Merck KGaA, AstraZeneca, Bristol-Myers Squibb, and Kite, are providing further validation of its technology.

The firm rolled out a go-to market strategy for the US in the third quarter of 2019 that involved establishing a direct sales team to drive commercialization, Verrelst said.

In partnership with Nichirei Biosciences during Q4, Biocartis completed registration of the Idylla instrument and console with Japan's Pharmaceuticals and Medical Devices Agency. Nichirei is marketing the platform in combination with Idylla research-use-only assays to local pathology laboratories in Japan.

The molecular diagnostic test developer also completed a joint venture with Wondfo in Q1 2019, with the aim of achieving Chinese market penetration. Under the terms of the deal, the two companies will share a 50/50-owned joint venture that will license Biocartis' Idylla platform in China.

For 2020, the firm is expecting US market clearance for its Idylla MSI Test for colorectal cancer via a 510(k) submission to the US Food and Drug Administration.

www.360dx.com/business-news/jp-morgan...

[verwijderd] 17 januari 2020 09:56

0

quote:
Reply schreef op 17 januari 2020 09:28:
JP Morgan Healthcare Day 4: Biocartis, Oxford Immunotec

Jan 16, 2020 | Leo O'Connor

SAN FRANCISCO – The 38th annual JP Morgan Healthcare Conference wrapped up on Thursday here with a handful of diagnostics and biotech companies presenting. Below are brief reports on the presentations and breakout sessions of Biocartis and Oxford Immunotec covered by our reporter at the conference. For our previous coverage this week, please see this page on our site.

Biocartis

Biocartis CEO Herman Verrelst said his firm is well positioned through continued menu expansion and new partnerships to achieve "substantial volume growth" over the next few years.

The Belgium-based molecular diagnostic test developer placed 337 new instruments in 2019, well within its guidance, he noted.

As of Dec, 31, the installed base of its Idylla molecular diagnostic instruments reached 1,310, and the number of cartridge sales hit 175,000, representing a year-over-year increase of 32 percent.

In 2019, Verrelst noted, the firm received CE-IVD marking for and launched the Idylla MSI Test and launched the Idylla ctEGFR Mutation Assay on a research-use-only basis. The company also announced a collaboration agreement with Bristol-Myers Squibb focused on MSI testing and inked a commercialization agreement with Kite, a Gilead Sciences subsidiary, aimed at development of molecular-based assays on the Idylla platform to support Kite's therapies.

The agreement with Kite is part of Biocartis' ongoing plans to expand its presence in oncology with a series of immunotherapy and liquid biopsy assays on the Idylla platform, Verrelst said.

He said that with a high double-digit growth rate each year, oncology is the fastest growing segment of a global MDx market worth $6.5 billion.

Biocartis' partnership with Genomic Health will add high value genomic signatures to its menu, and partnerships with pharma giants, such as Amgen, Merck KGaA, AstraZeneca, Bristol-Myers Squibb, and Kite, are providing further validation of its technology.

The firm rolled out a go-to market strategy for the US in the third quarter of 2019 that involved establishing a direct sales team to drive commercialization, Verrelst said.

In partnership with Nichirei Biosciences during Q4, Biocartis completed registration of the Idylla instrument and console with Japan's Pharmaceuticals and Medical Devices Agency. Nichirei is marketing the platform in combination with Idylla research-use-only assays to local pathology laboratories in Japan.

The molecular diagnostic test developer also completed a joint venture with Wondfo in Q1 2019, with the aim of achieving Chinese market penetration. Under the terms of the deal, the two companies will share a 50/50-owned joint venture that will license Biocartis' Idylla platform in China.

For 2020, the firm is expecting US market clearance for its Idylla MSI Test for colorectal cancer via a 510(k) submission to the US Food and Drug Administration.

www.360dx.com/business-news/jp-morgan...

Very nice, the share price will rise sharply in the coming months and years.

[verwijderd] 17 januari 2020 11:05

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quote:
Laup 4 schreef op 17 januari 2020 09:56:
[...]
Very nice, the share price will rise sharply in the coming months and years.

Het zal daarbij vanzelfsprekend allemaal stapsgewijs gaan waarbij, zoals door meerderen hier op het forum aangegeven, de nadruk vooral zal liggen op de ontwikkelingen in de tweede jaarhelft van 2020.

De hatelijke € 5 regionen lijken nu in elk geval tot het verleden te behoren.

Forza Biocartis! ;-)

Flatlander 17 januari 2020 14:49

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I saw several news articles regarding sepsis yesterday. Most had the same awareness message that sepsis is responsible for 20% of the deaths in the world. I thought it would be a great lead in for Immunexpress to announce EU marking of Septicyte Rapid!

Okay - maybe a little wishful thinking going into the weekend.

FL

[verwijderd] 17 januari 2020 17:06

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MDx market movements:

Roche Diagnostics & Illumina partnership
www.roche.com/media/releases/med-cor-...

Thermo Fisher Scientific & Labcorp partnership
www.businesswire.com/news/home/202001...

Flatlander 17 januari 2020 18:40

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D.vdB

This is precisely the trend I was pointing out the Genexus System is evidence that Fisher is trying to target faster and cheaper sequencing to open new markets by going down the food chain. In this case LabCorp is a behemoth and the parent company of our partner Covance. However, the fact of the matter is that Labcorp has numerous genetic experts on staff to interpret the NGS sequencing results. The average physician office, urology clinic, dermatologist, etc may be looking for simpler answers. Is one of the most common gene mutations present that would make a patient a candidate for a targeted drug therapy.

To me this may also show that Fisher had some conflicts that pushed BCART into deciding to change to their current go to market strategy. The important part of these press releases is that the platform costs are much higher than Idylla. They also anticipate the relationships being in existence for 15 years. This suggests the time frame that these major players see MDX, CDx continuing to grow and expand over.

I'd love to see a side by side comparison of the costs for a Roche -Illumina assay (the IVD kit and the platform) for a common assay say MSI vs the cost for the Idylla platform and the MSI cartridge. Assuming that the IVD kit is cheaper than the Idylla cartridge, how many assays would need to be run before recouping the cost of the Illumina NGS platform.

Often we look for evidence of another IDV PCR platform emerging as a competitor. Quite possibly the competition will come from cheaper, faster NGS platform. Right now there is a wide cost difference and simplicity/accessibility gulf. But I think this is something we need to watch.

Have a good weekend

[verwijderd] 17 januari 2020 19:03

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I do not understand what they are doing FL. I'm quite sure that Idylla is much more cost efficient because labs need less medical staff and less infrastructure. Good idea to compare prices.

Have a good weekend too :-)

brightlight 17 januari 2020 19:49

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There are quite a few posts about NGS lately. I think we should frame this, for those investors who don't want to dig this deep into the technical side, that we are talking about something that might (or might not) become a problem for Bcart in five years time or later. By that time Bcart will have evolved too, and rest assured that Bcart is monitoring NGS and other cutting edge technologies closely.
BL

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