Forum: Galapagos » Galapagos in oktober 2016

NielsjeB 30 oktober 2016 20:48

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winx08 schreef op 30 oktober 2016 20:35:
[...]

Dat had ik precies hetzelfde. Slecht gevoel na de webcast, goed gevoel na lezen van de transcript, en volgens mij werd in beide hetzelfde gezegd........

Vond ook de opmerking van Piet mbt de 25% Crohn scores wel mooi. Hoezo vergelijkende cijfers publiceren die toch niets betekenen. Ergo, als je wilt vergelijken, vraag dan Celgene maar om de 50% scores :-)

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

NielsjeB 30 oktober 2016 20:50

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quote:
Pl4 schreef op 30 oktober 2016 16:50:
[...]

Ik heb die verwachting niet. In het verleden behaalde resultaten bieden geen garantie voor de toekomst, maar meer dan onderstaande citaten verwacht ik niet.

- De zeepbel loopt langzaam leeg
- Ik verwacht maandag een koersdreun
- Het aandeel zal in elkaar storten
- DL blijft zelfstandig en de koers gaat terug naar 4
- Galapagos is lucht

Etc

Zonder onderbouwing, de treurigheid druipt er af bij oma (oud takkenwijf)

Exactly, en dan wel in willen stappen aan 50 euro. Hoezo opportunistisch? Overigens zijn zijn/haar "bijdragen" op alle forums van hetzelfde laken een pak.

egeltjemetstekel 30 oktober 2016 21:00

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quote:
JacobusJW schreef op 30 oktober 2016 20:04:
[...]
Daar zit wat in.
Ik was er al van overtuigd dat de standstill periode niet later zou eindigen dan de lock-up periode, maar je kunt weleens gelijk hebben dat het juist vroeger is.

En ik ga er juist van uit dat de standstil langer duurt dan de lock up.
Waarom? op de laatste borrel bij gala heeft onno toen hij aangaf dat de duur van de Standstill niet bekend mocht worden, zich duidelijk versproken toen hij zei dat het de bedoeling was van het management om "na die jaren" een marktwaarde te hebben die ervoor zou zorgen dat een overname scenario te duur zou worden voor gilead.
Hieruit kun je dus opmaken dat de Standstill tenminste meerdere jaren duurt, mijn gok was toen dat het een jaar of drie zou zijn om enige overlapping te geven aan de periode die resteert totdat filgotinib de markt bereikt maar dat zou dus ook 4 of 5 jaar kunnen zijn al lijkt me dat wel wat lang.
Mijn gedachtenkronkel, doe er mee wat je wilt.

[verwijderd] 30 oktober 2016 21:05

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egeltjemetstekel schreef op 30 oktober 2016 21:00:
[...]
En ik ga er juist van uit dat de standstil langer duurt dan de lock up.
Waarom? op de laatste borrel bij gala heeft onno toen hij aangaf dat de duur van de Standstill niet bekend mocht worden, zich duidelijk versproken toen hij zei dat het de bedoeling was van het management om "na die jaren" een marktwaarde te hebben die ervoor zou zorgen dat een overname scenario te duur zou worden voor gilead.
Hieruit kun je dus opmaken dat de Standstill tenminste meerdere jaren duurt, mijn gok was toen dat het een jaar of drie zou zijn om enige overlapping te geven aan de periode die resteert totdat filgotinib de markt bereikt maar dat zou dus ook 4 of 5 jaar kunnen zijn al lijkt me dat wel wat lang.
Mijn gedachtenkronkel, doe er mee wat je wilt.

Okay, dat wist ik niet. Gilead zal waarschijnlijk niet happy zijn met een dergelijke opmerking. ;-)

egeltjemetstekel 30 oktober 2016 21:11

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quote:
JacobusJW schreef op 30 oktober 2016 21:05:
[...]
Okay, dat wist ik niet. Gilead zal waarschijnlijk niet happy zijn met een dergelijke opmerking. ;-)

Gilead moet niet zeuren, die hebben met filgotinib waarschijnlijk een gouden blockbuster ;-D
Oh what a tough business world....

[verwijderd] 30 oktober 2016 21:18

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Morgen hertel van ht pessimisme?

[verwijderd] 30 oktober 2016 21:20

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Morgen herstel?

egeltjemetstekel 30 oktober 2016 21:27

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quote:
Tagomago schreef op 30 oktober 2016 21:20:
Morgen herstel?

dit soort vragen kun je het beste stellen aan glazen bol staarders.
Ik heb niet eens zo'n ding...

[verwijderd] 30 oktober 2016 21:36

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omaneus schreef op 30 oktober 2016 20:05:
[...]precies. En ik verwacht te kunnen instappen onder de 50

Nee nikste precies. Fundamenteel verschil tussen jouw verwachtingen, die nergens op zijn gebaseerd, en de mijne.

Was het niet zo dat chicken bullish werd een DAG voor de alltime high en dat ik verwijzend naar zijn signaal en het artikel van Bret Jenson waarschuwde. Nee? Ben ik een leugenaar?

Was het niet zo dat contra indicator rond de 56/57 € weer pessimistisch was? Is vervolgens de koers niet weer naar de 62€ toe gegaan? Verzin ik dit?

Gaf contra indicator bij die top niet aan dat hij long zat? Gaan we sindsdien niet weer omlaag? Zuig ik dit uit mijn duim?

Nee dat doe ik niet.

Wordt hoog tijd dat je met deze onzin stopt en begint te focussen op chicken. Die zal het signaal geven wanneer de koers omhoog gaat en niets of niemand anders.

[verwijderd] 30 oktober 2016 22:21

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omaneus schreef op 30 oktober 2016 16:00:
verwacht maandag weer een koers dreun.

Omaneus je weet het niet,wel een leuke bezigheid heb jij!
Niets anders te doen neem ik aan grapjas!

egeltjemetstekel 30 oktober 2016 23:43

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omaneus schreef op 30 oktober 2016 20:05:
[...]precies. En ik verwacht te kunnen instappen onder de 50

Zag ik jou laatst niet op een bezemsteel langs de maan vliegen?
Kon aan je silhouet zien dat je een behoorlijke neus hebt zeg...

[verwijderd] 31 oktober 2016 00:24

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quote:
omaneus schreef op 30 oktober 2016 20:05:
[...]precies. En ik verwacht te kunnen instappen onder de 50

Als u dat verwacht dan kunt u ook gewoon een doorlopende aankooporder Galapagos inleggen op 49,99 of nog lager. Dat is eleganter dan forumleden op dit, en meerdere andere IEX forums, dagelijks te vervelen met allerlei glazen bol berichten over dalende koersen. Bij voorbaat dank, succes.

MtBaker 31 oktober 2016 07:11

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Er is geen pessimisme, Wat we zien is hoog volume aanbod op tijdstip opening Nasdaq in zowel US als Amsterdam rond dezelfde tijd. Conclusie, er is een partij die belang heeft bij lagere koersen en die beschikt of kan beschikken over aandelen. Dat kan dus een potentiele koper zijn die meer aanbod wil bij lagere prijs of iemand die probeert de geloofwaardigheid van de presentatie te verlagen gezien de timing. We zullen wel zien de onderste bollinger band fungeerde als stop.
In ieder geval voor de traders en deelhandelaren weer een van de vele bijkoopsituaties.

egeltjemetstekel 31 oktober 2016 07:17

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seekingalpha.com/article/4016799-gala...

Galapagos NV's (GLPG) CEO Onno van de Stolpe on Q3 2016 Results - Earnings Call Transcript
Oct.30.16 | About: Galapagos (GLPG)
2016 Earnings Summary
Slides News Press Release
Galapagos NV. (NASDAQ:GLPG)

Q3 2016 Earnings Conference Call

October 28, 2016 08:00 AM ET

Executives

Elizabeth Goodwin - IR

Onno van de Stolpe - CEO

Piet Wigernick - Chief Scientific Officer

Bart Filius - CFO

Analysts

Tim Woodward - Goldman Sachs

Michael Vlemmix - KBC Securities.

Phil Nadeau - Cowen & Company

Anastasia Karpova - Kempen

Debjit Chattopadhyay - Janney

Hugo Solvet - Bryan Garnier Securities

Operator

Hi, everybody and welcome to our audio webcast today. I am Elizabeth Goodwin, Investor Relations. And I'll be hosting the event. You can view the webcast on our website, www.glpg.com. And it will be available for replay on our website later on today.

So that your questions can be included, we request that you call into the telephone number given in the press release. I've got one right here for you. 32, for Belgium, 24-00-6926, and the code is 2352766.

Moving on, I'd like to remind everyone that we will be making forward-looking statements during today's audio conference. These forward-looking statements include remarks concerning future developments of the Company and possible changes in the industry and competitive environment. Because these forward-looking statements involve risks and uncertainties, Galapagos' actual results may differ materially from the results expressed or implied in these statements.

Today's speakers will be Onno van de Stolpe, CEO; Piet Wigernick, CSO; and Bart Filius, CFO. Onno and Piet will go through the operational highlights of the third quarter, and Bart will explain the financial results. Onno will then close with the considerable news flow we expect over the next year or so.

You will see a PowerPoint presentation on screen during this presentation, and we estimate that the talk will take about 20 minutes or so, and will be followed by a Q&A session. So at this point, I'd like to hand over to Onno to begin the presentation.

Onno van de Stolpe

Thank you, Elizabeth. Pleasure to be in the talk, and talk about the highlights of the last quarter. It's been a great quarter for Galapagos; with filgotinib we have started the first Phase 3 in the history of the Company in rheumatoid arthritis, which is of course a hallmark for the Company.

But not only that, in filgotinib we're moving forward in IBD, in Crohn's disease and ulcerative colitis, where we are expecting to start Phase 3 dosing very shortly. So really, we're rolling out filgotinib in these diseases and many others to come.

At the conference, we discussed the data of filgotinib in Crohn's, especially the endoscopy and histopathology data, which were well looked for, especially in the context of the competition data from Celgene's Mongersen, and our data came out very nicely in comparison. So we were very pleased with that as well.

Also in the third quarter, we obtained an orphan status for 1690; it worked with developing idiopathic pulmonary fibrosis, which is currently in a Phase 2 trial. We're also very pleased that we had the first dosing in our antibody that we're developing together with MorphoSys in atopic dermatitis, so a lot of progress in the pipeline.

And if we go to the next slide, if you look at that pipeline, you see that it's becoming larger and larger over time, with two new additions compared to the last time we presented this pipeline. At the bottom, you see 2938 for idiopathic pulmonary fibrosis and other mechanisms of action that we're developing, and it's now moving towards Phase 1; and 2534 for atopic dermatitis.

This is what Galapagos is about. It's about new mode of actions around targets that we discover with our platform and that we're moving forward through discovery into development.

Of course, the focus of the investors is the latest-stage programs. Filgotinib that Piet will discuss in more detail in the various diseases, our CF program with our collaborate at AbbVie, with which we're making a lot of progress and currently in Orlando we are presenting a lot of process on the progress in this disease area.

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egeltjemetstekel 31 oktober 2016 07:25

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2016 Earnings Summary
Slides News Press Release
We talked about 1690 in autotaxin, an autotaxin inhibitor that we're developing for IPF. And we're also very excited about the collaboration that we have with Servier in osteoarthritis with 1972 for which we will start, Galapagos will start, a Phase 2 program in the United States next year.

With that short overview of the pipeline, I would like to hand it over to our Chief Scientific Officer, Piet Wigernick.

Piet Wigernick

Thank you, Onno. So first highlight of Q3 for us of course was the kickoff of the FINCH program for filgotinib. FINCH is the large Phase 3 program with filgotinib in RA. We developed 100 and 200 milligrams with three different studies, aiming at a broad label across multiple lines of therapy in RA.

The FINCH Program will include in total more than 3,000 patients, and has the classic attributes of currently run or recently run Phase 3 programs in RA, meaning active control is included, X-ray endpoints are included, studies with duration of either 24 or up to 52 weeks.

So with the FINCH Program first patients have been included in Q3, we will be able to be showing that filgotinib is really the best JAK1 inhibitor in the space, and it will come out as well with probably the best safety profile. So we're very pleased with the progress our partner Gilead has shown over the quarter for RA.

So second highlight on the next slide was of course, the data of filgotinib in Crohn's. So at the UEG Week conference in Vienna, we for the first time shared with the outside world the endoscopy data.

So the FITZROY study was a 10-week study that we powered to show a difference on the clinical endpoint, the CDAI improvement and the CDAI remission.

We've reported those data before. But in Vienna, for the first time we showed the endoscopy data. And for us the critical criteria there is the number of patients with at least 50% improvement. And we've shown clearly independent of the reading, a medical advantage for the treatment group over the placebo group. I can tell you that for the local reading, you're very close to the statistical significance of 0.05.

So it was only in a couple of patients that that was missed there. So although the study was not powered, a clear advantage there as well on endoscopy for the active treatment.

Next to the endoscopy as well, we've shown for the first time data on the histology. Histology measure is on the next slide.

Histology measures whether the tissue really is improving, and you want to have a look at that to long-term cure of the Crohn's. So the total score consists of both the activity which is more on the surface and the second score which really looks deep into the tissue. And both of these endpoints, again, the active-- the 200 milligram group showed clearly better than the placebo, giving us a nice statistical difference as a total score on activity score, showing that filgotinib in Crohn's does just what we expect from future treatments for Crohn's. It's an oral treatment. It will have a high level of clinical remission. And it will fundamentally, as well, heal the disease in a number of patients. So excellent data for filgotinib out of the FITZROY study.

So these data allowed us to discuss with authorities both in Europe and the U.S. on the next slide, the Phase 3 program in Crohn's. And we've made a similar Phase 2 Phase 3 program in UC. So this is the Phase 2 Phase 3 program in Crohn's is called the DIVERSITY Program.

The DIVERSITY will include more than 1,300 patients will be on treatment for 58 weeks. They will go for remission, endoscopic endpoints, and we will have an endoscopy baseline with them on week 58, so allowing us to both report activity and an induction and a maintenance study. And for all patients we will include them in a long term extension study where we will collect more maintenance data.

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egeltjemetstekel 31 oktober 2016 07:26

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2016 Earnings Summary
Slides News Press Release
In Copy Paste program we started in UC, there we still have to do Phase 2, interim and all this -- that we will run smoothly into Phase 3. But more or less the same design, but then the Mayo score as the endpoint compared to the DIVERSITY Program.

But again there, in the first study where we do induction and maintenance, and the long-term study where we collect all the patients and data on long-term maintenance with these patients.

Also these programs will start into patients soon. We expect those patients to be included in Q4. And then we feel filgotinib will have two active Phase 3 programs, and a new indication Phase 2 before yearend, which were the goals we have set for ourselves and for which we have to thank as well our partner, Gilead, again.

On the next slide, moving to this week's news was the CF news. First a view on the CF portfolio, as said before, our plan is to aggressively move forward different compounds along the different components of our triple combo. So we have our lead potentiator 1837 in Phase 2. From a different chemical -- which we have potentiator 2451 as well in Phase 1 ongoing. And then we've recently added to that from the same chemical 2451 potentiator is 3067, which we will move forward to Phase 1 as well early next year.

On the C1 corrector I call them early, yes we have two compounds, 2222 moves into patients as we speak, and then in pre-clinical its backup is 2851. And then I can confirm here that we are on track to start a Phase 1 with 2737 in Q4 of this year. So we are really aggressively move forward different compounds for the different components of the triple combo we are aiming for.

Next slide, so this week for the first time we've shown the data from the SAPHIRA program. SAPHIRA program is a program we're in Phase 2 for the first time we do studies in CF patients with 1837. So SAPHIRA consists out of two studies.

SAPHIRA 1, where we include G551D patients; SAPHIRA 2, where we include patients with a mutation which is typical for the Benelux countries around where we are located. And this week we published SAPHIRA 2 data.

So recruitment for both studies has run in Europe and Australia. For the first time, I think, we have designed studies, or the company has designed studies where we could include both patients that have not been on a treatment or were on Kalydeco treatment. So for those we have seen a 7 day washout period.

The design as well was that we did not include placebo, so to give the patients maximum chance of getting access to active treatment. So we have a 4-week design that we escalate the dose within the patients. You will see that later as well. And then we follow them up for a short period, and bring them back to the treatment if they were on Kalydeco before.

So SAPHIRA 2, we have the data as we speak. SAPHIRA 1 has been completed. So 26 patients were include and will read out before year end.

Next slide please. So SAPHIRA 2 first feature of the design was washout. So we've chosen for a 7-day washout of ivacaftor. So we had three patients on ivacaftor. I can tell you they were on treatment for more than one and two years, so not patients that moved recently on ivacaftor, but only patients that had been on the treatment for a long time.

And so what you can see on the left is that if you take treatment away, within 7 days the sweat levels increase, so that is where the sweat chloride is a biomarker we measure at the skin. And within seven days, you see it moving here as well, so a slight FEV decline.

I think if you would put patients for in total [indiscernible], because that's how long the treatment takes, you would see, or you would expect an FEV decline of more in the range 8% to 10%. So the first 7 days what we see, it's a limited number of patients. And so we have to be careful here. But we saw a 3% FEV decline.

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egeltjemetstekel 31 oktober 2016 07:28

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2016 Earnings Summary
Slides News Press Release
On the right of this slide, you'll see the naive patients. So they have not been on treatment, so their sweat is stable. And as well, their FEV levels stay stable between screen and day minus 7 and baseline, than medication starts.

The next slide, so we have increased dose in SAPHIRA 2 after 2 weeks. So patient took first 62 milligrams bid during two weeks. And then 125 milligram bid in the second of week three and four. And we see that the exposure came in at the lower end of our expectations. That has been a bit unfortunate in SAPHIRA 2.

That meaning, so patients were a little bit under-dosed the first two weeks, who showed a low level of activity. And then the second half, they showed clear activity, but still suboptimal.

So in terms of FEV, which you see on this slide, you can see that in the ivacaftor pre-treated patients, we did not see a further decline. So we believe that's a sign of biological activity. If we would treat them optimally, you would want to see the 3% loss being restored. But take care, patients have only been for two weeks on the really active dose, and then we'll see it on the optimal dose probably.

And then on the right you'll see the ivacaftor naive patients. So for two out of three, we see a nice increase of around 4% to 5%. There's one patient which starts with a very low FEV so a percent of FEV of less than 40%. It's well known for this type of patient that they have a hard time in showing an FEV increase. So it's much harder in this type of patients to show a 5% to 10% FEV increase.

So we are pleased with this data. They clearly show that our compounds as well have an impact on the FEV. But we have to take care so a small study, a small number. But the trend is there that on FEV we have seen impact.

Next slide, we also did measure sweat chloride. There the same picture, so the first two weeks low level of activity, with only two out of five patients showing an increase, and then a little increase of 50 millimol per liters, which is the threshold for calling this a change of sweat chloride.

The second part of the study with increasing the dose, four out of five patients get to the [Indiscernible] as well. One patient gets to a high level 50 millimol change of sweat chloride. These are drops of sweat.

So I show the same picture, the low level of exposure in the first two weeks really caused effectively a suboptimal activity, three signs of activity. To get the full power of 1837, we should have included a higher dose, which will be part of the SAPHIRA 1.

And next slide please. So the conclusion for SAPHIRA 2 safety and the storability, the compound performed as we expected. So the typical side effects which we see in early clinical studies, but nothing to be worried. So our big goal, of course, is not to go ahead [ph]. We've always said that the SAPHIRA 1 shows better results compared to Kalydeco that we will develop 1837. So we have to wait for year-end data. So I can promise you those data will be there before yearend, and then we'll see how well it performs on mono therapy.

Our big goal is really the triple combo. And to that respect, we have 2451, 2222; which really have a once-a-day PK profile. And so by yearend we should as well have the Phase 1 data of 2737, and then showing us whether we can really go for the once-a-day compound with this triple combo, or whether it's going to be bid, because 2737 is a bid compound.

And then 1837 comes in the mix as well with more data, as part of the full SAPHIRA program. But so the choice hasn't been made yet. And we will decide that around year end.

Next slide, so moving forward, a triple brings us into a very intensive CF program. So these are the clinical studies only. So SAPHIRA on top with potency, with only patient evaluation. 2451 in Phase 1 as we speak, we've dosed cohorts this week. So it is moving on nicely. And 2222, Phase 1 completed, and we'll move into patient studies soon, as well as we speak, first as a mono therapy, and later we will add combo study data as well. And then 2737 starting Phase 1, as planned, in Q4.

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egeltjemetstekel 31 oktober 2016 07:29

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2016 Earnings Summary
Slides News Press Release
We'll obviously see the combinations as soon as we have sufficient 2451 and 1837 view. And then we will start the combinations P+C1 early next year. And then a triple combination first in healthy volunteers, first off, and then moving into patients with triple, second half of next year. So that's really our goal. We believe, we are on track.

This week, in that sense was a good week for us. So we really believe that at this time as for the triple combinations are quite competitive in this field, where a number of companies try to move forward triple combos for delta F508 heterozygous and homozygous patients.

Also for CF, I believe, next slide; as well in Q3 for the first time we dosed a first antibody out of our portfolio, MOR106 to patients. So MOR106 is a new antibody against a novel target. The target is the IL-17C cytokine. So IL-17C belongs to the IL-17 family. Most of you will know that IL-17A has shown excellent results-- has been approved for psoriasis. So IL-17C has dual mode of action. So it drives the release of IL-17A. So if you block IL-17C, we should block the production of IL-17A. And it has a second mode of action. So it directly blocks, as well, on the epithelia, the receptors to which a number of IL-17.

So our IL-17C antibody has a dual mode of action. We'll have to see and work out whether this is competitive, better than IL-17A. We have a dual method of action. So we should not exclude it. But on the other hand as well, we pretty well know that for psoriasis, the bar to show high efficacy is extremely high. So we've kicked off that. We're studying atopic derm patients first. And then we'll decide later when we have those data.

I think that concludes my part of the presentation.

Bart Filius

Thank you very much, Piet. And good morning for those in the U.S. Good afternoon for those in Europe. My name is Bart Filius, CFO of the Company. Let me walk you through the financial results of the third quarter, or I should say the 9 months up until the end of September.

So I'll start off with the cash slides that you have seen before. So at the end of September, cash position was about €940 million, resulting from the cash in that we had earlier this year from the Gilead transaction, both through the up-front as well as through the subscription to shares; and the cash burn that was €78 million for the first nine months of this year. That €78 million, if you extrapolate that to the full year, makes us believe that we will be in the range that we provided for before, between €100 million and €120 million of total cash burn excluding income from Gilead.

The €940 million that we have at the end of September excludes still tax receivables that will pay up over the next 4 to 5 years from the French and Belgian governments, and a total of €67 million is now on our balance sheets at the end of September.

If I then move to the next slide, on revenues, strong increase in revenues, 38% to €65 million over the first nine months. And not only is it a strong increase, but it's also an increase which is to a large extent cash based. And I've tried to picture that through the different color coding. The orange elements are more or less, cash income; whereas the green code, its parts are what I would call accounting income.

The accounting income is associated with the up-front that was paid to us by Gilead. We recognized over the first 9 months €17.6 million out of the €300 million up-fronts. And the additional €39 million that was the premium to the share subscription. So a significant portion of that amount is still to be recognized over the next 3 to 4 years.

And the remainder is cash-based income, fee for service income from our subsidiary [Indiscernible] increasing to €6 million; milestones €18 million; cost reimbursements from our partners AbbVie and Gilead, €9 million; and finally €50 million, which is largely grants as well as tax incentives from the French and Belgian governments that we receive and now also receive in the form of cash in the course of 2016.

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So a good position on revenues, then on operating expenses, keeping this more or less flat; a slight increase to €113.5 million over the first nine months. As you can see on the chart, the research expenses are a bit higher. Development is a bit lower. That might be counterintuitive for some of you, because we obviously are now starting Phase 3.

But I remind you that in 2015, those development expenses included 100% of the charges that we were bearing for the DARWIN programs around filgotinib. Whereas year to date September 2016, those expenses are driven by 20% of the Gilead filgotinib program, as well as the development costs for cystic fibrosis.

So hence, a small decline, but you should expect this to go up meaningfully over the next couple of quarters, as the Phase 3 programs will start to accelerate around filgotinib.

SG&A expense finally is up slightly. To a large extent, this is driven by accounting costs related to our warrant program, as a result of the increase of the share price; and to a smaller component, because of some increase in operating expenses in SG&A as well.

Then lastly, this concludes to our net results and earnings per share. €8 million positive net results, year to date September. I remind you that this is largely driven by a one-off accounting entry that we had recorded in January when we closed the share subscription agreements.

As you might remember in 2015, we had a negative entry in 2016, a positive entry of €57.5 million, which is representing the premium that Gilead has paid on our share price at the time of closing.

So this is accounting. The actual operational evolution between the first 9 months of 2015 and the first 9 months of 2016 is €12 million, which is a reflection of the higher revenues against more or less stable expenses.

So with that, I give it back to Onno for the outlook.

Onno van de Stolpe

Thank you, Bart. If we look at the clinical news flow over the remainder of the year and what's already planned for next year, you'll see that it's quite extensive. For the first time we have split the clinical news flow in two slides, because of the number of programs that we'll provide data going forward.

You see that there's a lot of news flow around filgotinib. I would like to focus on top of what Piet has said on the start of multiple proof-of-concept studies with filgotinib in other diseases in 2017. That will start early in that year, and we will announce that when those studies start.

With CF, Piet has already highlighted the number of programs that are going into various stages of the clinical trials, with the aim to get the triple started midyear next year, so exciting times there as well.

If we go to the next slide with the other news flow on the other programs, you see that with 1690 we hope to report the top-line data in the first half next year. We will start Phase 1 with the other IPF program 2938.

With Servier, as I said at the beginning, we are moving forward with our OA program, the disease modifying drug here, a very interesting market opportunity, where Galapagos has the unencumbered U.S. rights. And we'll start independently of Servier, a Phase 2 study in the U.S.

With MorphoSys, we're looking forward to the data from the first trial in 2017, and hope to follow it up with a start of a Phase 1B study.

And then another program in atopic dermatitis, 2534, we'll start Phase 1 in 2017 as well. So a lot data coming up last quarter, but also in 2017. So the investors will be served to what they're looking for.

With that, we would like to end the formal presentation. I'm handing it back to Elizabeth.

Elizabeth Goodwin

All right. Thank you, Onno, Piet, and Bart for the presentation. I'd like to invite the operator now to instruct callers as to how they can pose a question.

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Question-and-Answer Session

Operator

[Operator Instructions]. We will now take our first question from Tim Woodward from Goldman Sachs. Your line is open. Please go ahead.

Tim Woodward

Hi there. It's Tim Woodward from Goldman Sachs. Thanks for taking my questions, two, if I may please. The first is on SAPHIRA 2, did you see the efficacy that you would have expected to from your in vitro? The reason I ask is I guess if you decide to go forward with 2451 in the triple combination, then you will be relying on that in vitro data of efficacy, rather than in patients.

And so the second is, can you just describe what you can do differently and what you can take across from your findings in SAPHIRA 2 into how you're conducting SAPHIRA 1? Thanks very much.

Piet Wigernick

Okay. But I think your question is for me?

Tim Woodward

Yes, please.

Piet Wigernick

Yes, please. On SAPHIRA, well, SAPHIRA 1 is concluded, so all patients have been on treatment. So what we're doing is analyzing the study, so there's nothing out of the lessons from SAPHIRA 2 that can change SAPHIRA 1, as it is coming too late. What I said before is that SAPHIRA 1 is exploring a higher dosing, so the dose there is clearly higher in SAPHIRA 1 than compared to SHAPHIRA 2. So patients will be higher exposed. And we remain for the moment blinded for data, and we'll bring them to the world as soon as we know them. And that's foreseen in December this year.

On what we've learned from SAPHIRA 2 in the in vitro data, so as I said in this call before, exposure came out at the lower end of our expectations. So, this study SAPHIRA 2 allows us to fine-tune to see where we can improve for the future programs. But quite honestly, we think the SAPHIRA 2 data confirms that our in vitro data translates into clinical activity. Of course, we didn't max out. But we saw with higher exposure we are convinced that we will get to, as well, a maximum of activity.

Limitation of SAPHIRA 2, it was a very small patient population. We knew that. But it was one with [Indiscernible] mutation, so it allowed us to explore the lower end of the dose range. So that's why we wanted to do that. So we have those data now, which we need if we want to move forward with 1837. So we will have safety data across a broad exposure range.

For 2451, you're correct, if we move forward then in patients that will again start from the pre-clinical in vitro data. And that needs to translate into a dose which will refine our dose prediction models with all of the data coming out of the SAPHIRA 1 and 2. Thank you.

Tim Woodward

Thank you.

Operator

We will now take our own next question from Michael Vlemmix from KBC Securities. Your line is open. Please go ahead.

Michael Vlemmix

Good afternoon, everyone. I'll start with two questions. My first one is regarding the safety results of the SAPHIRA 2 study. Can you maybe elaborate a bit on the adverse events, the headaches that were seen with both the low and the high doses in this population? Were these during the entire four weeks of treatment and more of a chronic type, or standalone acute events? I'm just looking at this purely in theoretical, if you were to increase dosage for these patients, how that would potentially evolve.

And then, the second question regarding the poster presentation of the Read-Through agents, the addition of those, showing nice results. And I was wondering if adding those types of agents would be a potential add-on in the future trials to increase efficacy? Thank you.

Piet Wigernick

Okay. Thank you again for these quite good questions. Safety, SAPHIRA 2, what we've observed there is what we typically observe in Phase 1 and Phase 2 early studies, when very little is known about [Indiscernible] exposure of the patients. So headaches were transient, and it was not an acute form. But that's what we always see, and observe in almost every study we do, so nothing to worry about there. And as well, we are confident that we can dose higher, which has been done as part of SAPHIRA 1.

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