Beursonline.nl

egeltjemetstekel 31 oktober 2016 07:49

2

2016 Earnings Summary
Slides News Press Release
So we will report those higher doses by year-end, and all that we can indeed confirm that those headaches were something that we see all the time.

So on the Read-Through agent additions, so the whole CF field has been sharing one ambition is to find treatments for all of the patients in the CF field. So the main focus of the program and short-term focus of the program is clearly homozygous and it means delta F508. But one another day, we as well want to tackle the class 1 mutations, where indeed by adding a Read-Through agent, we can go and treat those forms as well.

So it's on the agenda, but not for the near term. Complexity there is that we probably will have to go with experimental drugs. And then you have to do also combo tox [ph] upfront, so that doesn't make our life easy, if that's with an external compound. But it's on the agenda. But I can't give you any timing there. Thank you.

Michael Vlemmix

All right. Thank you.

Operator

We will now take our next question from Vamil Divan from Credit Suisse. Your line is open. Please go ahead.

Vamil Divan

Great. Thanks so much for taking my questions. I just had a couple, more on just the data flow you discussed and when we should expect public disclosure. So for SAPHIRA 1, you mentioned you'll have that by yearend. So should we expect some sort of top-line press release when you have that? And will it be sort of reasonable expectation in terms of a medical meeting to see that data?

And then similar for next year, I see all the data that you're laying out between the potentiators and correctors and going into the triple. Is there anything we'll see publicly in terms of the double or anything else, before you move to the triplet in healthy volunteers, or certainly by the time it goes into patients?

Piet Wigernick

Onno, do you want to take that question?

Onno van de Stolpe

Well, regarding the first question, we anticipate to come out with the top-line data in a press release by the end of this year. Piet, have we decided yet on a scientific conference that we're going to present the data?

Piet Wigernick

Well, normally there is one in June in Europe, a CF conference. So I think the logical thing is that we'll be present there in June. But I don't have the date yet and the place. But there's always a European CF conference first half, and then an American North American in second half. So we should be present there at the European conference.

Onno van de Stolpe

Regarding your second question, I think we haven't decided yet how we're going to communicate the dual data, at what time, and if we're already in the triple before the dual is going to be published. Piet, that's correct, right?

Piet Wigernick

Yes. What we do there is we're going to try to accumulate as much of the information as we get in terms of safety exposure, and if so, we don't really in there to quickly close those studies. If you want to move quickly forward with our triple combo later, the more safety we can get, the better, and that's where we will open a number of Phase 2 studies, but not with the aim of publishing data quickly, rather with the aim of getting as much safety as we can, and convert those studies from a mono to a dual later, and by expanding those studies. So we don't have a plan there to quickly converge dual data to any conference.

Vamil Divan

Okay. All right. Thanks so much. I'll jump back in the queue.

Operator

We will now take our next question from Phil Nadeau from Cowen & Company. Please go ahead.

Phil Nadeau

Good morning. Thanks for taking my questions. First a follow-up on SAPHIRA 1, given the exposures that you saw here in SAPHIRA 2, where do you think the exposures will be in SAPHIRA 1 at the doses used in comparison to the EC50s and 90s in the G551D population? Do you still feel comfortable that the doses will get you sufficient exposures well into the efficacious range, or are you now worried that the doses might be a little too low?

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egeltjemetstekel 31 oktober 2016 07:51

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2016 Earnings Summary
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Piet Wigernick

Okay. Thank you. No. For SAPHIRA 1 it's clear we are confident that we'll get to the exposures where we can be at least as good as Kalydeco and hopefully the in vitro translates that we can show some superiority over Kalydeco. We don't think we'll get up to the EC90s anymore. That's clear. But there is still quite dose range between EC50 and EC90. And so we are confident that we'll get to at least as good, and hopefully better, in terms of efficacy than Kalydeco, if our in vitro data translates into in vivo.

Phil Nadeau

Okay. And then second, on that -- I believe that SAPHIRA 1 also had a dose increase strategy two weeks at a lower dose, two weeks at a higher dose. Can you give us some sense of what sort of chloride changes and FEV1s you'd expect after two weeks at the higher dose? Can you remind us maybe what Kalydeco produced on those two measures after two weeks?

Piet Wigernick

Thank you. So if I understand well, what was FEV increase seen with Kalydeco after two weeks, so the FEV increase was in the range of 3% to 4% after two weeks of dosing in the S1251N population. So we can send that paper out, there's a paper published by the CF work group. And if you only dose for two weeks, a 3% to 5% is a reasonable expectation.

Phil Nadeau

Sorry. Was that for G551D or 1251? I'm actually asking about G551D for the future dataset?

Piet Wigernick

In both 51 patients I mean. So that's what you can compare to today. So in SAPHIRA 2 we dose patients with S1251 mutations. So comparing apples-with-apples, so comparing with the 1251 data of Kalydeco, there you are in the range of 3% to 5% of FEV improvements after two weeks of dosing.

Phil Nadeau

Right. So I guess I was asking about the G551D population. So we can set a benchmark for the data that's coming up at the end of the year. Do you have the equivalent figures for G551D?

Piet Wigernick

We expect somewhat higher. It should be more 6% to 8% and 10% after two weeks. So data that the increases were higher, even after only two weeks of dosing.

Phil Nadeau

That's very helpful. And just one last question on the healthy volunteer study or the healthy volunteer Phase 1 dosing of your triple, it looks like you've allocated about six months to complete that. I think a lot of us also cover Vertex, and just saw them take just about 12 months to complete a healthy volunteer portion for their triple, despite the fact two elements of that combo were basically either approved or already in Phase 3 trial. So what gives you confidence that you can complete the healthy volunteer Phase 1 portion of your triple in just six months?

Piet Wigernick

Based on what we currently see in terms of safety and exposures with the compounds that have either been in Phase 1, 2222, 1837, and what we hope to see with 2737. I think the Vertex program clearly has its complexities, and that never speeds things up. So, clearly I think the way we plan it is how we've planned this before. And our timelines in Phase 1 have been quite constant over the years. So I don't see a reason why this would take longer than what we've planned.

So I'm not saying that some groups can't prefer to do much more or longer studies. But the way we built up from one or two dual and then to triple should allow us to perform it within the timeframe foreseen.

Phil Nadeau

Thanks. Thanks for taking my questions and congratulations on the progress.

Operator

We will now take our next question from Anastasia Karpova from Kempen. Your line is open. Please go ahead.

Anastasia Karpova

Good afternoon. I have two questions, if I may. Can you please comment on the 2222 trial in combination with Kalydeco potentially, how big that would be, and what you would be looking for?

And maybe on competitive landscape, does data that Vertex recently published yesterday on the VX-59 [ph] change your view on the required effects you would like to see from your triple combination? Thank you.

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egeltjemetstekel 31 oktober 2016 07:52

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2016 Earnings Summary
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Piet Wigernick

Okay. So the first one, the 2222 study and indeed the study in CF patients, thank you for the question-- is a study on top of Kalydeco. So, we expect a couple of things from that study. Safety first, exposure of women [ph] patients, first with 2222. So we have quite of flexibility with 2222. And our hope for that is that the PK will be as expected. But that's the first thing that we expect there. Safety exposure is the second.

And then Vertex have shown before that in some of the G551D patients when they did add 661 that they saw a further change, a limited change in sweat, and some further improvements of FEV. There is a debate on those data, whether we still will get that type of improvements when patients have been longer on treatment. That's a possibility.

If we see it that's nice, if you don't see that is not a problem, because it's mainly a safety study. But if you see some activity there, we will report, that's for sure. No problem. Then on the pre-clinical data of Vertex, I can add little. I think broadly we go for triple combinations. We both see that we get, if we add the Kalydeco [Indiscernible] we improve efficacy two, three, four fold pending on the donor [ph]. So I really was pleased with what we've learned this week, and we are convinced that we have a competitive or more than a competitive triple in the reach, and that we're going to develop. I didn't see any reason why we would have to change anything on what I have published this week.

Anastasia Karpova

Thank you very much for taking my questions.

Piet Wigernick

Thank you.

Operator

We will now take our next question from Matthew Harrison from Morgan Stanley. Please go ahead.

Unidentified Analyst

Hi. This is Vikram on for Matthew. Just one question from our side. On filgotinib in Crohn's, are you planning to provide a 25% responder rate, just so that people can compare the dataset with the Celgene data that was released? And if so, when could we expect that?

Piet Wigernick

Okay. Thank you for that question. The [Indiscernible] data on the 25%, honestly we don't have any plans to leave those data. Our KOL [ph] said before the 25% doesn't mean anything. So we don't see why we should add data that doesn't mean anything to our KOL. We are very happy with our 60% improvement score, and are confident that that will translate as well into Phase 3.

And from a sideline, then my observation is that too many people try to interpret studies which were not designed, which are not powered for [Indiscernible]. So whether you report 25% or a 50% improvement, they are simply were not powerful. So you will always get a number that tells you something, but can't tell the full story. And that's why they advise us to take the most difficult hurdle, 50%. If you see something there, it will give you more confidence as you count powers in the Phase 2 for efficacy and for [Indiscernible]. So, no, we don't plan, in short, to remove those data.

Unidentified Analyst

Okay. Thank you.

Operator

We will now take our question from Debjit Chattopadhyay from Janney. Your line is open. Please go ahead.

Debjit Chattopadhyay

Hey, thank you for taking my questions. Let me start with filgotinib. Could you clarify the plans for the 200 milligram dose in TNF naive patients, male TNF naive patients in the US? Will those patients be rolled over into the maintenance portion of the study, or how do we think about them statistically once they finish the safety portion?

Piet Wigernick

Can you please repeat the question, whether I can explain -- so it's the TNF experience in the FINCH 2 study?

Debjit Chattopadhyay

Yes. In the IBD program that 200 milligram dose…

Piet Wigernick

Okay, yes. Sorry.

Debjit Chattopadhyay

So, the question is in the IBD program, the 200 milligram dose in male patients who are TNF naive; how are we going to account for them statistically? Are they going to move to the maintenance portion of the study, or the initial -- the 10-week induction phase, once they finish the safety portion?

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egeltjemetstekel 31 oktober 2016 07:53

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2016 Earnings Summary
Slides News Press Release
Piet Wigernick

So, we will not collect as part of the IBD program, data with the 200 milligram in TNF naive patients for IBD in the US. So those data will have to come out of the U.S., where most of these patients are located. So we will make sure that we have sufficient male patients, TNF naive, 200 milligram across the globe to compensate for the few patients in the U.S. that can't be included. So that is the question. But they will be remain in the US on the same dose. So that's how that's going to be taken care of.

Debjit Chattopadhyay

Okay. Now moving to the SAPHIRA 2 program, could you comment on the lower sweat chloride response in the SAPHIRA 2 versus the FEV1 response? It seemed to be very much in line with what we have seen for Kalydeco, given the small number of patients in the S125N patients.

Piet Wigernick

Okay. Thank for the SAPHIRA 2 question. Lower sweat chlorides were two possible causes. Either that's what we really think is that exposure was suboptimal, and that as part of SAPHIRA 1, we will do that. We will increase exposure. We should get to a full response there, so that we then get higher sweat chlorides.

Second possibility is that lungs and skin differ a bit. So when we predicted those, we really targeted for the lungs. And maybe we did favor a little bit there the skin, and that might be a reason why for a compound that tends to penetrate better in the lungs probably compared to the skin, we see better efficacy compared to sweat chloride changes.

But there is no clarity there. Let's be honest. That's the second possibility. That, of course, complicates the whole picture. If you want to later dose range based on sweat, so then you must be sure that your compound penetrates as well into sweat as into the lungs. And so we will have to watch that and analyze carefully as part of the SAPHIRA 1, where we have one more patient, and where we do three dosages rather than two. So we should get a better picture there. But if it's due to the penetration throughout the skin, okay, then we have to think carefully how we're going to design future studies if we want to change our dose type rate [Indiscernible].

Debjit Chattopadhyay

And just one clarification on the SAPHIRA 1 study; did I hear you say before the doses that you're evaluating, the higher doses that you're evaluating in SAPHIRA 1 will get you very close to the Kalydeco dose in terms of efficacy?

Piet Wigernick

Yes. So SAPHIRA 1, indeed. Thank you for the question. SAPHIRA 1 we designed to explore whether in vitro we see a higher Emax with 1837 compared to Kalydeco. And the dose range we apply will allow us to see whether indeed that translates in vivo into higher efficacy. So with the current data of SAPHIRA 2, we should not think that we get up to the EC90, where you got up to one on the 50% of the efficacy of Kalydeco. But we should be at least as good, and probably somewhat higher, than Kalydeco as part of SAPHIRA 1.

Debjit Chattopadhyay

And one last question. On the second potentiator, do you think you need mono-therapy study in any one of these mutation subgroups, or based on the early volunteer data that you'll present next year, you should have enough to directly start thinking about triple combo? In which case, which one do you really want to take forward, the twice daily or the once daily? Thanks so much for taking the questions.

Piet Wigernick

Thank you for two additional questions. I think for patients that need to be treated lifelong, mono-therapy would be a clear advantage, so there's clearly a preference for once a day. But of course efficacy will trump everything. So if you really need to [Indiscernible] efficacious at the combo. But a once-a-day would have an advantage.

And well, we believe that based with the SAPHIRA program, then the 2222, which should start into patients as well, will be able moving without those single-studies, those mono-therapy studies, 2451 if needed, into patients immediately without a need of mono-therapy studies.

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egeltjemetstekel 31 oktober 2016 07:55

2

2016 Earnings Summary
Slides News Press Release
Debjit Chattopadhyay

Great. Thank you so much.

Elizabeth Goodwin

I think we have time for one last question, if there is still one.

Operator

[Operator Instructions] There are no further questions – beg your pardon. Our next is from Hugo Solvet from Bryan Garnier Securities. Please go ahead.

Hugo Solvet

Hi. Hello. Thank you for taking my question. Just if we look ahead in six to nine months, you will moving in Phase 2 trial for the triple combo. What are the interactions you have with the U.S. centers at the moment and how do you anticipate competition with Vertex who might be looking in some centers at the moment? Anything you can share on this subject?

Piet Wigernick

Okay. Thank you for the question. First off, well until now we've run the CF program mainly outside the U.S., so it's clearly part of the program to move quickly into the U.S. And we will use there the different components of the program, the mono, the dual, and the triple as soon as we can. So we don't want to underestimate the competition with Vertex. They are very well-established in the field. They know everybody. So they probably will get access easier to patients than we.

On the other hand, the CF community is a very motivated field, and really hopes for a number of drugs, and to be able be to choosing between drugs. And there's only one way that a number of centers are going to include patients in trials of other companies, as well. Otherwise there is -- and they know that if they only test the Vertex, they'll be in the hands of Vertex, and there will be probably little choice later on in the market.

And so having the freedom to choose between therapies is what they desire as well. And that desire requires then that also other companies get access to patients, and on the sales part of the SAPHIRA program we've been very pleased with how those teams have been working with us.

So, I don't want to underestimate the Vertex advantage they have. Let's be clear. But we believe that -- and we are in the field now. The feedback as well is that we will get access to the patients. Don't forget for the triples you have homozygous population, [Indiscernible] is there, but is not really serving fully that population. So maybe patients are either not taking or either are underserved. So we should be bringing it there to participate, delta F508 [Indiscernible] patients, so there is no treatment. So they as well, we believe there will be sufficient patients who will be included in our studies. But we are not going to underestimate it. Thank you.

Hugo Solvet

Thank you.

Elizabeth Goodwin

All right. Well, thank you, everybody, for all the excellent questions. Our next financial results will be for the full year 2016. We'll be presenting on the 3rd of March next year. So thanks to everyone who watched and dialed in, and asked some questions. We look forward to speaking with you again very soon. Take care, and good-bye.

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[verwijderd] 31 oktober 2016 08:11

0

quote:
NielsjeB schreef op 30 oktober 2016 20:48:
[...]
Ik mag hopen dat in beide hetzelfde staat, maar ik heb zo'n idee dat de webcast leidend is ;)
Waarom een slecht gevoel bij de webcast? Uitstekende vragen, met uitstekende antwoorden. Alleen de dose response in Saphira 2 liet misschien wat te wensen over, maar daar is m.i. een afdoende antwoord op gekomen.

De SA transcripts worden bijna volledige automatisch in elkaar gedraaid, vandaar ook het [indiscernable] bij de CSO. Maar dat had ik tijdens het luisteren eigenlijk ook regelmatig, misschien een nieuwe microfoon aanschaffen voor dhr. Wigerinck :P

Het is een bekend gegeven dat als je naar een discussie kijkt (bv trump-clinton) je wellicht een ander beeld vormt dan dat je het via de radio hoort. Mijn persoonlijke ervaring ging dus een stap veder, namelijk tussen horen en lezen. Wellicht dat de beroerde audio kwaliteit (@HelloUsa, doe daar eens wat aan )van Piet, in combi met zijn manier van spreken. Overigens, ik probeer absoluut NIET te suggereren dat Piet minder moet zeggen in dit soort Webcasts. Integendeel zelfs, hij komt op mij over als eerlijk en betrouwbaar.

December zal de volgende Saphira resultaten geven en ons pas inzicht geven in de kansen op CF gebied van Galabb. De data is beschikbaar maar nog geblindeerd. Werking zal al te zien zijn alleen ´weten´ ze niet welke arm het is. De volgende quote was voor mij veelzeggend:
"So I really was pleased with what we've learned this week, and we are convinced that we have a competitive or more than a competitive triple in the reach, and that we're going to develop. I didn't see any reason why we would have to change anything on what I have published this week."

ooh ja, Celgene werd nog even op z´n nummer gezet en er komen meer 634 toepassingen. Schijnwerper stond vrijdag op CF, terwijl 634 er stiekem tussenuit demarreerde. Mijn benieuwen wanneer de commentatoren dat in de gaten krijgen.

cheers.

[verwijderd] 31 oktober 2016 08:16

1

quote:
egeltjemetstekel schreef op 31 oktober 2016 07:17:
seekingalpha.com/article/4016799-gala...

...

Neem aan dat je het hele verhaal erop pleurt voor mensen die niet op een vreemd linkje durven te klikken. Kan je ook even het volledige jaarverslag en kwartaalverslag op de draad zetten ? scrollt zo lekker weg.
thanxs.

[verwijderd] 31 oktober 2016 08:27

0

De 5 koersdoel adviezen van de laatste maand liggen tussen 67€ en 84€.

[verwijderd] 31 oktober 2016 08:28

0

quote:
winx08 schreef op 31 oktober 2016 08:11:
[...]

ooh ja, Celgene werd nog even op z´n nummer gezet en er komen meer 634 toepassingen. Schijnwerper stond vrijdag op CF, terwijl 634 er stiekem tussenuit demarreerde. Mijn benieuwen wanneer de commentatoren dat in de gaten krijgen.

Helemaal eens, veel positieve bonus hints in de presentatie, het beste moet nog komen: nog wat CF vuurwerk in december en dan in 2017 de gestage opmars gesteund door de snelrijpende ontwikkelingen op meerdere fronten, januari 2018 hopelijk even wat teleurgestelden dat ze niet direct worden overgenomen en dan wordt het pas echt leuk! Je zou denken dat ik er haast niet op kan wachten, maar het tegendeel is waar.

[verwijderd] 31 oktober 2016 08:34

0

quote:
egeltjemetstekel schreef op 31 oktober 2016 07:55:
2016 Earnings Summary

Ab'tjes voor de moeite.

[verwijderd] 31 oktober 2016 08:48

0

quote:
winx08 schreef op 31 oktober 2016 08:16:
[...]

Neem aan dat je het hele verhaal erop pleurt voor mensen die niet op een vreemd linkje durven te klikken. Kan je ook even het volledige jaarverslag en kwartaalverslag op de draad zetten ? scrollt zo lekker weg.
thanxs.

Om die transcripts te lezen moet je volgens mij een account hebben.

MtBaker 31 oktober 2016 08:48

0

quote:
JacobusJW schreef op 31 oktober 2016 08:27:
De 5 koersdoel adviezen van de laatste maand liggen tussen 67€ en 84€.

ja duidelijk hoger dan hetoude gemiddelde onder 67.

[verwijderd] 31 oktober 2016 08:55

0

quote:
egeltjemetstekel schreef op 30 september 2016 21:38:
Mooi artikel! Dankje staycalm.
Ben het niet helemaal eens met alle conclusies van seren...

-overname is wel mogelijk indien er een ander bod komt

Een "ander bod" dan je zelf in gedachten had bedoel je hier denk ik.. maar ik weet toch niet wat jij in gedachten had?

-waarom Gilead niet die 1.x miljard wil betalen in 2019, dat gaat ten koste van de winst, liever een overname.

Mee eens.

-Standstil van 2 a 3 jaar

De 2 a 3 jaar wordt gesuggereerd door de interviewer en niet bevestigd door onno dus hier kun je niet van uit gaan.

-en de mogelijkheid van een spin-out van research

Mee eens.

etc..

Egeltje ,
Plaats je de uiteenzetting ook nog even op het novemberdraadje ;-)

kwekkel 31 oktober 2016 09:24

0

egel top AB

NielsjeB 31 oktober 2016 10:10

0

quote:
winx08 schreef op 31 oktober 2016 08:16:
[...]

Neem aan dat je het hele verhaal erop pleurt voor mensen die niet op een vreemd linkje durven te klikken. Kan je ook even het volledige jaarverslag en kwartaalverslag op de draad zetten ? scrollt zo lekker weg.
thanxs.

Ik zal de volgende keer een pdf-je ervan maken. Dit allemaal plaatsen is wel erg veel van het goede als je het mij vraagt. In Chrome kun je gewoon opslaan als PDF.

Moet je echt lid zijn van SA om die link te openen?

egeltjemetstekel 31 oktober 2016 11:11

0

quote:
Medion50 schreef op 31 oktober 2016 08:55:
[...]

Egeltje ,
Plaats je de uiteenzetting ook nog even op het novemberdraadje ;-)

Oh dat kan, maar is dat niet een beetje dubbel?

[verwijderd] 31 oktober 2016 11:34

0

quote:
egeltjemetstekel schreef op 31 oktober 2016 11:11:
[...]
Oh dat kan, maar is dat niet een beetje dubbel?

Veel mensen houden immers van pumpen, maar dergelijke pumpreacties op een forum hebben geen enkele invloed op de koersvorming van een aandeel.
Alleen is de kleine aandeelhouder daarvan geenszins op de hoogte.

[verwijderd] 31 oktober 2016 11:37

0

quote:
NielsjeB schreef op 31 oktober 2016 10:10:
[...]
Ik zal de volgende keer een pdf-je ervan maken. Dit allemaal plaatsen is wel erg veel van het goede als je het mij vraagt. In Chrome kun je gewoon opslaan als PDF.

Moet je echt lid zijn van SA om die link te openen?

Je kynt de link wel openen maar als je niet ingelogd bent dan krijg je volgens mij maar een klein deel te zien van de artikelen. Tenzij ze superkort zijn.

[verwijderd] 31 oktober 2016 11:49

0

Kans is groot dat u s à ht naar beneden helpt maar nu wat vakantiedagen en niet veel omzet

[verwijderd] 31 oktober 2016 11:49

0

Kans is groot dat u s à het naar beneden helpt maar nu wat vakantiedagen en niet veel omzet

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