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Bron: DeTijd

Analisten reageren opgelucht op het nieuws dat Biocartis BCART zijn (weliswaar verlaagde) jaardoelstellingen heeft behaald. Het aantal geïnstalleerde Idylla-minilabo's steeg met 337 stuks naar 1.310 terwijl de doelstelling lag op een aangroei van 325 tot 350 stuks.

De cijfers wijzen op een prille pick-up van Idylla in de Verenigde Staten, signaleert KBC Securities. 'Dit cijfer wijst op marktinteresse voor het product. We geloven dat Biocartis in de VS een slechte timing koos voor de lancering van Idylla, veeleer dan dat het product niet concurrentieel zou zijn', klinkt een hoopvolle Guy Sips, die zijn koopadvies herhaalt bij een koersdoel van 13,50 euro.

Ook de kaspositie van 179 miljoen euro lag boven de doelstelling tussen 170 en 175 miljoen euro. 'Dat is een bemoedigend resultaat, maar Biocartis is er nog niet', zegt het beurshuis Kepler Cheuvreux. 'Er zal nog meer nodig zijn om het vertrouwen te herstellen.' Kepler herhaalt zijn koopadvies met een koersdoel van 11 euro.

'We nemen aan dat de ramp-up in de VS nu echt vertrokken is', klinkt het bij Degroof Petercam. 'Dit volume geeft ons vertrouwen in de langetermijnvooruitzichten van het bedrijf', zegt analist Thomas Guillot die het aandeel onder review plaatst.
DRTVR
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Via bank al belegd in een korf,1ste maal dat ik me heb laten verleiden om zelf te beleggen, heb er vertrouwen in.
Flatlander
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BL

I agree that the differences in our numbers may very well be the source of the information on consoles and cartridges. I look at it as a quick and dirty confirmation that the system sales are resulting in increased usage of the platform. I may have pulled the numbers from an unaudited source.

FL
brightlight
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quote:

Flatlander schreef op 9 januari 2020 18:32:


BL

I agree that the differences in our numbers may very well be the source of the information on consoles and cartridges. I look at it as a quick and dirty confirmation that the system sales are resulting in increased usage of the platform. I may have pulled the numbers from an unaudited source.

FL

The differences are negligible and therefor unimportant.
BL
Flatlander
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I like tracking on a half year basis since we do not have that many data points. Either way the relative direction is the important point. This number could increase by a factor of 10 or more if the RUO designation can be replaced by clinical diagnostic approval in several world markets.

I have put up several posts that suggest that the problems in the U.S. may be more of a problem with the regulatory framework than a problem with Idylla. Unfortunately the FDA is trying to apply the medical device approval process rather than a more appropriate genomic testing standard that the Obama administration proposed over a decade ago. The FDA 510K process generally emphasizes precedents and requires the manufacturer to compare results to existing equipment already on the market. In the case of Idylla this is tough since there are no similar IVD devices to compare its results to. Former commissioner Gotleib had changing the IVD approval process as a priority but for whatever reason, he decided to resign instead. FDA has internal guidance documents (see link below) but not comprehensive legislation from Congress. This is the reason I keep mentioning that BCART may have to be assertive to counter the lack of appropriate guidance from Congress.

Here is an overview of the FDA process that BCART has to seek approval under.

www.fda.gov/medical-devices/ivd-regul...

Note that Idylla is likely bumping up against the De Novo classification (meaning no adequate precedent system exists for comparison). For this reason FDA might likely be requiring validation studies. It would seem that these are temporary hurdles, but none the less they hinder more rapid expansion of sales.

FL


Iceman
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De visie van KBC Securities

Ondanks het feit dat de groei van het aantal Idylla-installaties met 337 stuks onder de schatting van KBC Securities (350) ligt, gelooft analist Lenny Van Steenhuyse dat de belangstelling van de markt voor het product aanhoudt. Verder benadrukt hij dat Biocartis in de VS eerder kampt met 'timing issues' (langere overgangstijd van R&D-validatievolumes naar commerciële volumes) dan dat er een structureel concurrentieel probleem is.

De cartridgevolumes vertoonden in het vierde kwartaal een sterk herstel, wat KBCS ziet als een indicatie van herstel in de Amerikaanse markt vanaf de eerste helft van 2019. Met een volumegroei van 24% in de eerste helft van 2019 en 27% in het derde kwartaal van 2019, vertaalt dit zich naar een groei van 37% in de tweede jaarhelft.

Aangezien de herziene doelstellingen van Biocartis voor de eerste helft van 2019 destijds ingegeven waren door de teleurstellende prestaties in de VS, gelooft KBCS dat de groei van 25-30% wordt gedragen door de Europese regio en de rest van de wereld (RoW) en dat een eventuele opwaartse trend vanaf dat moment kan worden toegeschreven aan de prestaties van de VS. Onze analist schat dan ook dat het herstel in het laatste kwartaal te danken is aan een stijgende omzet in de VS.

Wat de cash betreft presteerde Biocartis in het vierde kwartaal beter dan KBCS had verwacht: de cash burn bedroeg 18 miljoen euro tegenover de prognose van 20,7 miljoen. Daardoor klokt de totale cash burn over het boekjaar 2019 op ongeveer 65 miljoen euro af. Zonder rekening te houden met investeringen voor een potentiële derde productielijn (die waarschijnlijk in 2021 zal worden opgezet), gelooft onze analist dat de cash burn dit jaar niet boven het niveau van 2019 zal uitkomen. Biocartis blijft als zodanig in een financieel comfortabele positie.

Op 5 maart maakt het bedrijf zijn volledige jaarresultaten bekend. KBC Securities bevestigt het koersdoel van 13,5 euro voor de aandelen en het "Kopen"-advies.
Reply
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Is het verder nog iemand opgevallen dat er in de eindveiling nog even voor zo'n 1 miljoen EUR aan stukken werd verhandeld?

Dat was echt een aardig pakket hoor wat daar snel nog even over de toonbank heenging!
Reply
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quote:

Flatlander schreef op 9 januari 2020 19:05:


I like tracking on a half year basis since we do not have that many data points. Either way the relative direction is the important point. This number could increase by a factor of 10 or more if the RUO designation can be replaced by clinical diagnostic approval in several world markets.

I have put up several posts that suggest that the problems in the U.S. may be more of a problem with the regulatory framework than a problem with Idylla. Unfortunately the FDA is trying to apply the medical device approval process rather than a more appropriate genomic testing standard that the Obama administration proposed over a decade ago. The FDA 510K process generally emphasizes precedents and requires the manufacturer to compare results to existing equipment already on the market. In the case of Idylla this is tough since there are no similar IVD devices to compare its results to. Former commissioner Gotleib had changing the IVD approval process as a priority but for whatever reason, he decided to resign instead. FDA has internal guidance documents (see link below) but not comprehensive legislation from Congress. This is the reason I keep mentioning that BCART may have to be assertive to counter the lack of appropriate guidance from Congress.

Here is an overview of the FDA process that BCART has to seek approval under.

www.fda.gov/medical-devices/ivd-regul...

Note that Idylla is likely bumping up against the De Novo classification (meaning no adequate precedent system exists for comparison). For this reason FDA might likely be requiring validation studies. It would seem that these are temporary hurdles, but none the less they hinder more rapid expansion of sales.

FL





The absence of comparable IVD devices to compare results should never be a reason for the FDA to block or delay medical progress and innovation.

I hope that the American partners of Biocartis can play a significant role in this regard towards the FDA.

Sometimes the FDA looks like an old-fashioned, stuck institute in a modern world.
brightlight
0
quote:

Flatlander schreef op 9 januari 2020 19:05:


I like tracking on a half year basis since we do not have that many data points. Either way the relative direction is the important point. This number could increase by a factor of 10 or more if the RUO designation can be replaced by clinical diagnostic approval in several world markets.

I have put up several posts that suggest that the problems in the U.S. may be more of a problem with the regulatory framework than a problem with Idylla. Unfortunately the FDA is trying to apply the medical device approval process rather than a more appropriate genomic testing standard that the Obama administration proposed over a decade ago. The FDA 510K process generally emphasizes precedents and requires the manufacturer to compare results to existing equipment already on the market. In the case of Idylla this is tough since there are no similar IVD devices to compare its results to. Former commissioner Gotleib had changing the IVD approval process as a priority but for whatever reason, he decided to resign instead. FDA has internal guidance documents (see link below) but not comprehensive legislation from Congress. This is the reason I keep mentioning that BCART may have to be assertive to counter the lack of appropriate guidance from Congress.

Here is an overview of the FDA process that BCART has to seek approval under.

www.fda.gov/medical-devices/ivd-regul...

Note that Idylla is likely bumping up against the De Novo classification (meaning no adequate precedent system exists for comparison). For this reason FDA might likely be requiring validation studies. It would seem that these are temporary hurdles, but none the less they hinder more rapid expansion of sales.

FL




FL
I track quite a few tech companies in the States. Many of them have a P/S ratio (ttm) upwards of 10, some even go as far as 30 or above. These companies are of course high growth names but many of them are also loss making. Remember that Biocartis, just as it is now, also has an annual sales growth upwards of 30%!! I estimate that FY19 it is trading at a P/S of 8.5, so that is quite reasonable for such a growth company. Of course I agree an acceleration in console growth would be welcome, but with the current console sales growth of around 330 units per year, and with a sustained cartridge sale of around 160 (80 per half year) per console, the overall cartridge sales increase would already be a very respectable 39.71% YonY according to my model. Imagine what an acceleration in either of the aforementioned variables would do! But my point is that even without an acceleration the stock is not overpriced and the growth still very impressive.
BL
Flatlander
0

While BCART was up on 6 times ave volume it closed on the low of the day. I hope Verrelst generates some enthusiasm at JP Morgan. It would be nice to move decisively from the lows of this week!

BL
I agree wholeheartedly that BCART is priced relatively cheaply for the current growth and especially for the potential future growth. My point was that the U.S. MDx market was becoming decidedly frothy. EXAS at a $15B market cap seems very expensive to me. Since so much of their potential worldwide growth in OncoTypeDx is dependent on Idylla, I'd much rather be in BCART since it would benefit from the launch of the same content throughout the world. Furthermore, I like platform companies. As long as partners keep stepping up to launch on Idylla they have a lot of shots on goal to accelerate from what is already very enviable growth.

Much of the US market is invested passively thru ETFs. I think they are damping the kind of volatility that would have shaken weaker hands out of the market. This is likely leading to overvaluation in some areas of the U.S markets. Earnings in the S&P were flat in 2019 yet the S&P Index was up 29%. I don't think you can pull that rabbit out of the hat too many years in a row. I'd much rather be investing in BCART despite the fact that it is far below the radar of most worldwide funds. The relative value difference convinced me to add to my position on Wed.

Regards FL

Wilfro
0
quote:

Reply schreef op 9 januari 2020 21:16:


Is het verder nog iemand opgevallen dat er in de eindveiling nog even voor zo'n 1 miljoen EUR aan stukken werd verhandeld?

Dat was echt een aardig pakket hoor wat daar snel nog even over de toonbank heenging!


Dat was mij ook opgevallen ja. Wat ik intussen ook heb opgemerkt, op de IR website van Biocartis wordt Sycomore niet langer vermeld als aandeelhouder. Daar zal spoedig ook wel een officiele transparantieverklaring voor komen. investors.biocartis.com/en/shareholders

Bovendien viel het mij ook op dat de aandelen die door mijn broker werden uitgeleend intussen niet langer zijn uitgeleend. Ik ben er dus vrij zeker van dat de shorters intussen de aandelen van Sycomore hebben opgekocht om hun short positie af te bouwen.

Dan nog een laatste ding, de totale short positie op woensdag bedroeg zo'n 3.5% terwijl de aandelen van Sycomore op dat moment al onder de 2.9% zaten. Naast de aandelen van Sycomore zullen de shorters dus ook nog andere aandelen moeten opkopen als ze hun positie volledig naar 0 willen krijgen.
loebas
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Sinds gisteren ingestapt in biocartis, opening price 6.15 met in de bid bedragen tot €7.00.
goeiemorgen iedereen :D
Jupken1337
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Reply
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Onderstaande RTL-Z Beurs Inside video is van einde 2018, net voor de spreekwoordelijke "hobbel in de weg" voor Biocartis in 2019.

Ondertussen weten we dat deze "hobbel in de weg" in Q4 2019 weer keurig is geplaveid door Biocartis en dat er momenteel weer vol gas gegeven kan worden.

Vervang in de video Fisher Scientific door het eigen Biocartis salesteam en weet dat de financiering van Biocartis ondertussen in 2019 op orde is gebracht. Dan resteert een enthousiaste "pitch" met een zeer positieve kijk op de toekomst voor Biocartis vanaf 2020.

www.youtube.com/watch?v=_ApN7bgSLBk
Flatlander
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Reply

Wish I spoke Dutch! The tone sounded positive.

I have a couple random thoughts.

I wish I knew the specific reasoning of Sycamore, JnJ, RM and DeBioPharm reducing or eliminating their stakes in BCART. DeBioPharm is a major investor in Immunexpress and much of their involvement with BCART seems to date back to the earliest stages of the Septicyte collaboration. RM appears to have sold in conjunction with his resignation from the Board. There appears to be a shift toward a more American based shareholder base. Invesco (formerly Oppenheimer), DFA have excellent reputations in small cap investments. I'm not overly concerned, but just like some sense of the motivation factors of fellow shareholders. Did the sellers take the H1 2019 numbers presented in September as more than a hiccup that it now appears to be?

Trading action in BCART looks good today. I was hoping to see such follow thru confirmation after the short term profit taking at the end of yesterdays session..

Have a Good Weekend.
FL
Flatlander
0
I'm not certain how the board translations are conducted but I notice that some words get changed to the point that they are nonsensical.
"earliest internships or" Was initially typed as "earliest initiation of"
I saw something in one of my previous posts about "be a hero" that I have no Idea how it was included in the post.
All in all, we are still fortunate to live in an age when we have tools to overcome language differences to converse across the Atlantic. Unfortunately, Americans as a whole are much less bilingual, trilingual ...than our European counterparts.

FL
Flatlander
0
Reply

The fact that the FDA approval process is the same as surgical instruments and the like rather that the specific MDx regulations that were proposed a decade ago is a testament to political dysfunction. You can probably sense my frustration with the issue. I'm sure FDA is also frustrated. That is why I keep stressing the fact that others have resorted to lawsuits when they felt they were at an impasse.

Funny thing is that our politicians from both parties grandstand about why the costs of health care in the U.S. are about twice that of other developed markets. Passing common sense legislation would go along ways toward bringing life improving products to the consumer.

Regards FL
Reply
0
quote:

Flatlander schreef op 10 januari 2020 17:27:


Reply

The fact that the FDA approval process is the same as surgical instruments and the like rather that the specific MDx regulations that were proposed a decade ago is a testament to political dysfunction. You can probably sense my frustration with the issue. I'm sure FDA is also frustrated. That is why I keep stressing the fact that others have resorted to lawsuits when they felt they were at an impasse.

Funny thing is that our politicians from both parties grandstand about why the costs of health care in the U.S. are about twice that of other developed markets. Passing common sense legislation would go along ways toward bringing life improving products to the consumer.

Regards FL


FL

As I said before. I hope that the American partners of Biocartis can play a significant role in this regard towards the FDA and frustration for all parties in the regulation process can be reduced to a minimum.

Have a Good Weekend
brightlight
0
quote:

Flatlander schreef op 10 januari 2020 15:44:


Reply

Wish I spoke Dutch! The tone sounded positive.

I have a couple random thoughts.

I wish I knew the specific reasoning of Sycamore, JnJ, RM and DeBioPharm reducing or eliminating their stakes in BCART. DeBioPharm is a major investor in Immunexpress and much of their involvement with BCART seems to date back to the earliest stages of the Septicyte collaboration. RM appears to have sold in conjunction with his resignation from the Board. There appears to be a shift toward a more American based shareholder base. Invesco (formerly Oppenheimer), DFA have excellent reputations in small cap investments. I'm not overly concerned, but just like some sense of the motivation factors of fellow shareholders. Did the sellers take the H1 2019 numbers presented in September as more than a hiccup that it now appears to be?

Trading action in BCART looks good today. I was hoping to see such follow thru confirmation after the short term profit taking at the end of yesterdays session..

Have a Good Weekend.
FL

FL,
I really would put these concerns to bed. Sycomore is an investment company and they probably saw better investment opportunities in the short run elsewhere, who knows. The DeBiopharm sale dates from May 23!!! (and was reported only in October), so well before the profit warning of September 5. RMM sale dates from 2018 even. The events are thus completely unrelated. The reason for the JNJ sale may well be that they bought the convertible with the aim of selling some shares later on. They probably stuck to that plan. Invesco even added to their position in 2019! There are a number of reasons why someone would buy or sell shares. The same applies to companies I suppose.
BL
brightlight
0
quote:

Flatlander schreef op 9 januari 2020 23:41:




BL
I agree wholeheartedly that BCART is priced relatively cheaply for the current growth and especially for the potential future growth. My point was that the U.S. MDx market was becoming decidedly frothy. EXAS at a $15B market cap seems very expensive to me. Since so much of their potential worldwide growth in OncoTypeDx is dependent on Idylla, I'd much rather be in BCART since it would benefit from the launch of the same content throughout the world. Furthermore, I like platform companies. As long as partners keep stepping up to launch on Idylla they have a lot of shots on goal to accelerate from what is already very enviable growth.

Much of the US market is invested passively thru ETFs. I think they are damping the kind of volatility that would have shaken weaker hands out of the market. This is likely leading to overvaluation in some areas of the U.S markets. Earnings in the S&P were flat in 2019 yet the S&P Index was up 29%. I don't think you can pull that rabbit out of the hat too many years in a row. I'd much rather be investing in BCART despite the fact that it is far below the radar of most worldwide funds. The relative value difference convinced me to add to my position on Wed.

Regards FL



FL,

As far as the overall market is concerned, as long as the FED and other central banks keep pumping money into the system, or should I say the stock market, every connection with the real economy will be lost. Concerning Bcart, indeed in my opinion too the stock is priced relatively cheaply for the current growth and especially for the potential future growth. I remember, after the September 5 profit warning, an analyst already said the price drop to 7.5 was overdone. So I think the stock price will return to that "more normal" level before long. Let's wait and see. I am also looking forward to the JP Morgan presentation of next week. Possible another positive surprise will be awaiting.

Have a nice weekend,
BL
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