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avantiavanti 18 januari 2018 15:28

15

No. 25 info mbt Galapagos. 207 pagina's rapport biotech breed. Extract pdf volgt straks.

Morgan Stanley 18 januari 2017.
PT up met 16% naar $127

Biotechnology

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Investment Thesis
We are Overweight Galapagos as we believe that filgotinib and the CF pipeline are differentiated and can take share.

Filgotinib has a differentiated profile versus its oral competitors - both Xeljanz and baracitinib. We believe it has best in class efficacy with a cleaner safety profile, especially on anemia. With additional positive data generated in Crohn's, we model peak filgotinib sales in RA and Crohn's of ~$4.5B by 2030E.

The CF franchise has a competitive emerging profile with preclincial data suggesting CFTR restoration rates above Kalydeco. We believe there is significant unmet need for new CFTR modulators/potentiators, but acknowledge competition exists from more advanced triple combinations from Vertex. We account for competition in our model.

Early data from pipeline assets MOR106 for AD and GLPG1690 for IPF have been encouraging enough for us to incorporate probability adjusted estimates for these molecules into our valuation. We await more mature data.
Key Value Drivers
The main drivers are advancement of filgotinib in RA and Crohn's and the CF pipeline.

Risks To Achieving Price Target
Development Risk: Phase III RA studies take significant time and the Phase II profile does not assure unknown side-effects in the larger Phase III program. Further, the CF assets are still relatively early stage, so safety/efficacy are not well understood.

Approval Risk: Regulatory approval is not assured and there is potential for failure to gain approval in one or more geographies.
Commercial Risk: The RA and CF markets are competitive with a number of marketed agents along with agents in development.

avantiavanti 18 januari 2018 16:11

7

Morgan Stanley 18 januari: Galapagos en Gilead extraxt vanaf pag 125.

Bijlage:

Ooievaar 18 januari 2018 17:11

1

Leuk om te lezen AvantiAvanti!

Jopie81 18 januari 2018 20:41

0

Bedankt voor het posten.

´Early data from pipeline assets MOR106 for AD and GLPG1690 for IPF have been encouraging enough for us to incorporate probability adjusted estimates for these
molecules into our valuation. We await more mature data´

Er zit nog voldoende rek in om koersdoel te verhogen.

avantiavanti 19 januari 2018 07:01

4

Te zwaar document, dus hij moet in delen.

Goldman Sachs december 2017

Americas Healthcare: Pharmaceuticals The Next Frontier in Autoimmune: Rising tide of new agents
We conducted a deep dive into the autoimmune market given the numerous agents on/coming to the market over the next few years and introduce a market model for the “big three” indications - RA, psoriasis and Crohn’s. We see a ~$39bn opportunity for the next gen autoimmune assets in the next decade, as big as projections for the immuno-oncology market but with a lot less investor attention. We expect all the next gen assets to be blockbusters (>$2.0 bn) given the room for market expansion and, as such, there are no real losers, although some agents stand out from the pack given the superior phase 3 data and commercial presence.

Bijlage:

avantiavanti 19 januari 2018 07:01

0

Deel 2 GS

Bijlage:

avantiavanti 19 januari 2018 07:02

0

Deel 3 GS

Bijlage:

avantiavanti 19 januari 2018 07:02

0

Deel 4 GS

Bijlage:

avantiavanti 19 januari 2018 07:03

0

Laatste stukje GS

Bijlage:

maxen 19 januari 2018 08:21

1

quote:
avantiavanti schreef op 19 januari 2018 07:01:
Te zwaar document, dus hij moet in delen.

Goldman Sachs december 2017

Americas Healthcare: Pharmaceuticals The Next Frontier in Autoimmune: Rising tide of new agents
We conducted a deep dive into the autoimmune market given the numerous agents on/coming to the market over the next few years and introduce a market model for the “big three” indications - RA, psoriasis and Crohn’s. ....

We believe ABBV will continue to enjoy a leadership position and maintain share in a ~1.5x larger autoimmune market (by the end of the next decade) bolstered by multiple best in class assets (Upadacitinib, Risankizumab). Further, ABBV should benefit from significant commercial advantage driven by its presence among physicians and payors (along with leading TNF, Humira). Among new players, GLPG/GILD emerge as the other winners with an impressive asset in Filgotinib, though we await more mature data to determine market presence.
...
We expect LLY’s Olumiant (Baricitinib) to be launched next year, ABBV’s
Upadacitinib and Risankizumab to be launched in 2019 and GILD/Galapagos’s Filgotinib to reach the market by 2020.
...
. In CD, data is still not mature enough but based on what we know Upadacitinib and Risankizumab seem the most compelling while Filgotinib has good safety data and could be first to market.
...
We believe GILD/GLPG’s JAK inhibitor Filgotinib is a solid asset with a
competitive profile and the potential to be first to market in GI where there is significant unmet need; we expect ~$5bn in sales by 2027 based on our market model.
...
De GS schrijvers van dit raport zijn veel positiever dan de 'vaste' GS analist voor GILD over Filgotinib sales, en vergelijkbaar met die van de vaste GS GLPG analist:
...
We note that our market model estimates differ from the published estimates for each of these assets which are risk adjusted. The overall un-risk adjusted estimates may differ as well given there are still several unknowns and as such, we aim to highlight areas of upside/risk relative to what is in our models based on the information we have today. We note that our GILD analyst includes only RA/CD indication for Filgotinib which are more conservative than our market model estimates pending further data (unrisk adjusted sales of $2.6bn for
Filgotinib in RA/CD vs. market model of $3.5bn by 2027). Our estimates are broadly inline with our estimates for GLPG and NOVN analyst, Keyur Parekh - for the indications that we model, we have unrisk adjusted sales of ~$5bn for
filgotinib vs. $5.3bn in our market model by 2027E

...
ABBV seems best positioned competitively based on Upadacitinib profile and its presence in autoimmune : Based on the topline data from the two phase 3 data sets seen (SELECT-NEXT and SELECT-BEYOND), we believe ABBV’s efficacy is more compelling than LLY’s bari on a placebo adjusted basis as demonstrated in exhibit 7 and 8. GLPG’s Filgotinib phase 2 data was impressive and if reproduced in phase 3 (expected 2H18) it would be largely comparable to Upadacitinib’s profile but would be 1-2 years behind the others. We note that amongst the three players, ABBV has a distinct commercial advantage to LLY and GLPG/GILD given their experience and leadership presence in autoimmune , particularly in RA through the Humira franchise. In addition to leveraging a strong and experienced sales force and existing physician relationships, we could see them taking an innovative approach to bundling the autoimmune franchise when approaching payers. In contrast, LLY has a more limited presence and GILD/GLPG have no presence in the RA market.

maxen 19 januari 2018 08:30

1

quote:
avantiavanti schreef op 19 januari 2018 07:02:
Deel 3 GS

Daar duikt de testicular safety weer op:

Filgotinib has shown impressive efficacy in Bio-naive patients; likely to be first to market. From the phase 2 Fitzroy study, Filgotinib has demonstrated compelling efficacy in bio-naive patients with less compelling efficacy in the tougher to
treat bio-IR patients relative to ABBV’s new assets. From a safety profile, while Filgotinib is least likely to have drug interactions making it suitable to be used in combination, testicular toxicity is a risk factor to watch especially if it leads to dose limitations and a resulting less potent efficacy profile (in male patients). It is important to note that GLPG is required by the FDA to complete a dedicated testicular toxicity study for their male patients based on a potential risk with Filgotinib 200mg as discovered during pre-clinical trials. At this point, we expect GLPG to be first to market in this indication with a 1-1.5 year of lead time and expect ~$1bn in CD sales by 2027.

Beurskingpin 19 januari 2018 09:17

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De GS schrijvers van dit raport zijn veel positiever dan de 'vaste' GS analist voor GILD over Filgotinib sales, en vergelijkbaar met die van de vaste GS GLPG analist

Vind je dat? Toxiciteit komt weer naar boven en upada is een betere molecule(profile) in hun ogen( wat niet zo is, integendeel)

avantiavanti 25 januari 2018 08:56

3

Kempen 24 januari 2018

BUY
Raise PT from 96 euro to 112 euro

Galapagos - Some JAKs are more equal than others

While 2017 was driven by an early-stage pipeline, 2018 is the year for filgotinib to shine. With 6 read-outs planned for 2018, filgotinib should not only confirm the best-in-class risk-benefit profile but also establish broad commercial opportunity driven by POC trials in satellite indications. We review the relative risks of the upcoming trials and set our benchmarks for desired efficacy and safety. With a wealth of newsflow and underappreciated phase II filgotinib pipeline, that could add up to €3b to its peak sales potential, we raise our PT to €112 ($137 for ADR) and reiterate BUY rating. Galapagos continues to feature on our Favorites list.

Bioteg71 25 januari 2018 10:26

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*UBS herstart volgen Galapagos met Neutraal advies en koersdoel van 95,00 euro

[verwijderd] 25 januari 2018 10:43

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quote:
Bioteg71 schreef op 25 januari 2018 10:26:
*UBS herstart volgen Galapagos met Neutraal advies en koersdoel van 95,00 euro

waar gepubliceerd en dus te lezen???????? Bron mag dan wel vermeld zijn maar is nu en zo nietszeggend....

Watermannetje2012 25 januari 2018 11:06

0

quote:
Dongen schreef op 25 januari 2018 10:43:
[...]
waar gepubliceerd en dus te lezen???????? Bron mag dan wel vermeld zijn maar is nu en zo nietszeggend....

Beursblik: UBS start volgen Galapagos
Koersdoel 95,00 euro.

(ABM FN-Dow Jones) UBS is begonnen met het volgen van Galapagos met een Neutraal advies en een koersdoel van 95,00 euro.

De analisten zijn voorzichtig gestemd over de commerciële potentie van Galapagos, maar daar staat de kans van een overnamebod op de onderneming tegenover. Hoe meer onderzoeksdata er evenwel over filgotinib vrij komt zonder overnamebod van het Amerikaanse Gilead, des te meer is dit volgens UBS een signaal dat de Amerikanen de voorzichtige blik van de bank delen.

Het aandeel Galapagos daalde donderdag 0,8 procent naar 92,14 euro.

Door: ABM Financial News.

info@abmfn.nl

Redactie: +31(0)20 26 28 999

Copyright ABM Financial News. All rights reserved

(END) Dow Jones Newswires

January 25, 2018 04:54 ET (09:54 GMT)

Dokter Bob 25 januari 2018 11:21

0

quote:
Watermannetje2012 schreef op 25 januari 2018 11:06:
[...]

Beursblik: UBS start volgen Galapagos
Koersdoel 95,00 euro.

(ABM FN-Dow Jones) UBS is begonnen met het volgen van Galapagos met een Neutraal advies en een koersdoel van 95,00 euro.

De analisten zijn voorzichtig gestemd over de commerciële potentie van Galapagos, maar daar staat de kans van een overnamebod op de onderneming tegenover. Hoe meer onderzoeksdata er evenwel over filgotinib vrij komt zonder overnamebod van het Amerikaanse Gilead, des te meer is dit volgens UBS een signaal dat de Amerikanen de voorzichtige blik van de bank delen.

Het aandeel Galapagos daalde donderdag 0,8 procent naar 92,14 euro.

Door: ABM Financial News.

info@abmfn.nl

Redactie: +31(0)20 26 28 999

Copyright ABM Financial News. All rights reserved

(END) Dow Jones Newswires

January 25, 2018 04:54 ET (09:54 GMT)

Dit slaat werkelijk als een tang op een varken

[verwijderd] 25 januari 2018 12:48

0

UBS adviseert nog snel haar relaties om te kopen.
Later in 2018 verhogen ze het koersdoel sterk.

De commerciële potentie van Galapagos en indirect Filgotinib, wordt grotendeels geleid door Gilead.
UBS verwacht daarentegen dat een overnamebod van Gilead tot de kans behoort...!
Dit staat niet los van elkaar, en dus slaat deze onderbouwing van hun koersdoel helemaal nergens op.

De scores van Filgotinib (4-6 studies) zullen moeten bewijzen dat Galapagos een hoger koersdoel gaat afdwingen. Alle vertrouwen daarin.

Het rapport van Morgan Stanley is trouwens ook van bedenkelijk niveau.
GLPG2938 in IPF is allang gestaakt en opgevolgd door GLPG3499.

Binnen de catalyst calender Morgan Stanley geen vermelding van alle scores Filgotinib die in jaar 2018 uitkomen, alsmede start Fase 2b/3 van GLPG1690 niet vermeld....

De webcast vragen van analisten vind ik laatste sessies van goede kwaliteit, maar het rapport van Morgan Stanley en motivering UBS zijn incompleet/onjuist/met een verkeerde strekking.

avantiavanti 2 februari 2018 12:05

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Onze vrienden van Leerink are getting at least the message mbt Upadacitinib en Filgotinib.

Extract uit Leerink, 1 februari 2018

The imminent FDA review of baricitinib will shed some light on the agency’s view of the role of these agents; given the favorable profile shown so far by Gilead’s filgotinib, there is the distinct possibility that even though
AbbVie have partially hedged their share losses with upadacitinib, the effect of the introduction of the JAK’s is likely to be net negative for AbbVie.

AbbVie’s JAKi Upadacitinib Still Has Risk

AbbVie’s most important pipeline asset is upadacitinib, a JAK1-specific inhibitor for inflammatory diseases. We forecast 2025E global revenues of $2.4bn ($3.7bn risk-unadjusted), consensus forecasts 2025E global revenues of $2.6bn, and AbbVie guided to sales >$6.5bn in 2025. AbbVie has press released and presented successful phase III results from 3 rheumatoid arthritis trials,
and the efficacy of the drug has been consistent and impressive. However, the reported 3 venous thromboembolic events (VTEs), including pulmonary emboli (PEs) and deep vein thromboses(DVTs), in the placebo-controlled portion of these phase III trials remains a concern, particularly in the context of Lilly’s delayed approval for baricitinib and certain disclosures about upadacitinib’ s relative JAK1 vs JAK2 specificity. There were 2 further VTEs reported in the published
upadacitinib phase II results, and 4 more VTEs in the crossover (i.e. non placebo-controlled) portion of the SELECT-BEYOND phase III trial from week 12 to week 24. This has been a concern for investors since Lilly received a complete response letter for baricitinib from the FDA on the basis of 5 VTEs, which translated into an event rate of 4.6 per 1,000 patient years of exposure.

The clinical literature suggests that an event rate of 6.1 per 1,000 patient years is typical for rheumatoid arthritis patients, which would appear to be consistent with the observed rate in the baricitinib studies. Nevertheless, the FDA appears to have had concerns that led to the complete response letter and delayed potential approval.

Our recent research into the safety of the entire JAK class, including the post approval reporting for Pfizer’s (PFE, MP) Xeljanz, did not suggest that JAK inhibition led to more VTEs than would be expected in the RA population (see our note here: “Ain’t Worried About JAK...Safety! AbbVie’s '494 Profile So Far Ok”).

However, AbbVie still has to present and publish the full results for 3 phase III rheumatoid arthritis trials in 3,000 patients, and any heightened safety signal will put at risk the multi-billion peak consensus forecasts and management’s guidance. As we have pointed out previously, even 1 or 2 VTE events could result in a change in the event rate, and could cross the threshold of
regulatory concern. We still believe upadacitinib is a very promising drug, but we also believe it has more risk for labelling restrictions than its direct rival, Gilead/Galapagos’ filgotinib.
At last public disclosure, filgotinib had only had 3 cases of VTE events in the entire development experience with the drug in 1,900 patients (event rate of 1.6 per 1,000 patient years), although this has largely been an inflammatory bowel disease population with lower baselinVTE risk, and no phase III rheumatoid arthritis data has been released to date. Filgotinib has also consistently
lowered platelet levels, rather than increased them, whereas the effect of upadacitinib on platelets has been mixed, with lower levels at lower doses and then flat to slightly increased levels at higher doses. There are no publications that thoroughly explore the effects of upadacitinib on platelets
in human studies, but AbbVie’s management has publicly stated that the drug led to “modest decreases” in platelet levels. However, negative hematopoietic effects, namely decreased hemoglobin levels, have been seen with the higher doses being advanced for upadacitinib, and there appears to be a dose-dependent loss of JAK1 selectivity within the therapeutic window.
If VTEs are associated with JAK2 inhibition, which baricitinib inhibits to a greater extent than Xeljanz (primarily JAK3), then upadacitinib’s suggested in vivo, dose-dependent inhibition of JAK2 may be a liability for the drug either in larger clinical trials or when it is subject to increased regulatory
scrutiny.

This lack of JAK1 specificity for upadacitinib has been corroborated by a pre-clinical study funded by the developers of baricitinib, Lilly and Incyte (INCY, OP). AbbVie’s internal data suggest that upadacitinib has specificity to JAK1 that is 74-fold higher to JAK2 in cellular assays and 10-fold higher than JAK2 in whole blood assays (IL-6 signaling then GMCSF signaling). In this analysis,
peripheral blood mononuclear cells (PBMC’s) were collected from healthy donors and used in an assay with the estimated plasma concentrations of each product’s phase III dose, or doses, for all the JAK inhibitors in development.
This analysis provided drug by drug dose-response curves for stat inhibition as measured by the inhibition of downstream phosphorylation of STAT proteins by
JAK1- and JAK2-dependent cytokines. From these dose response curves, the investigators established the half maximum inhibitory concentration (IC50) required for each drug.

STAT5 is phosphorylated by GM-CSF cytokine signaling through JAK2 only, and is a good marker to JAK2 specificity. While the results suggested that upadacitinib is a more potent inhibitor of JAK1 signaling compared to baricitinib and filgotinib, upadacitinib was also a more potent inhibitor of JAK2 compared to filgotinib and of equal potency to baricitinib. Specifically, upadacitinib had a
JAK2 IC50 of approximately 30nM compared to 65nM for baricitinib, but filgotinib had an IC50 >2000nM, or over 60-fold higher than upadacitinib (Exhibit 16). Given the once daily doses being studied by all these developers, the investigators estimated that at the highest dose JAK2 would be inhibited (above the IC50) by upadacitinib for 11 hours out of 24, or 45% of the day, whereas
for baricitinib it would be inhibited 50% of the day, and for filgotinib for only 5% of the day.

Even more importantly, the relative JAK2/JAK1 (GM-CSF to pSTAT5 / IL-21 to pSTAT3) IC50 for upadacitinib is 0.5, whereas for baricitinib it is 0.6 and for filgotinib it is 2.2. This study was conducted and sponsored by Lilly, and therefore is subject to all the liabilities and biases of company-sponsored research. However, this study suggests that on this dimension at least,
filgotinib might have the best profile, and baricitinib’s is somewhere in between.

Bijlage:

maxen 2 februari 2018 13:11

6

quote:
avantiavanti schreef op 2 februari 2018 12:05:
Onze vrienden van Leerink are getting at least the message mbt Upadacitinib en Filgotinib.

Extract uit Leerink, 1 februari 2018

...

Dit is wat GLPG al jaren zegt, maar het legt altijd meer gewicht in de schaal als een kundige analist het zegt.

Given the once daily doses being studied by all these developers, the investigators estimated that at the highest dose JAK2 would be inhibited (above the IC50) by upadacitinib for 11 hours out of 24, or 45% of the day, whereas
for baricitinib it would be inhibited 50% of the day, and for filgotinib for only 5% of the day.

Het hierboven geciteerde stukje vindt ik ook mooi. JAK1 blokkade is goed tegen RA, Crohns, UC, enz. Daarentegen wordt JAK2 blokkade ook geassocieerd met problemen, zoals met VTEs en PEs. Door de verschillende werkingen blokkeert Filgotinib de JAK2's slechts gedurende 5% van een dag, terwijl upadacitinib dat 45% van de dag doet, en baricitinib 50% van de dag. Dit alles geschat, bij dagelijkse inname, en bij de hoogst geteste doses. En hoe langer de blokkade van de JAK2's op een dag, hoe meer bijwerkingen er van komen.

Hoewel we dus echt nog phase III filgotinib moeten afwachten, lijken de berichten van het afgelopen jaar, met name betreft de VTEs en PEs, steeds meer te wijzen op de bevestiging van buiten dat filgotinib de veiligste JAK inhibitor gaat zijn. En dus liggen aangepaste voorspellingen over omzet en koersen voor de hand.

Overigens legde Goldman Sachs er op 19 januari de nadruk op de huidige aanwezigheid van Abbvie in de RA markt met Humira, en de voorsprong van upadacitinib t.o.v. filgotinib, om upadacitinib het marktleiderschap te beloven
(zie dit draadje op 19 januari en quote hieronder).
Maar gaat dat echt gebeuren ALS straks duidelijk is aangetoond dat filgotinib het veiligst is, terwijl de effectiviteit vergelijkbaar is?

ABBV seems best positioned competitively based on Upadacitinib profile and its presence in autoimmune : Based on the topline data from the two phase 3 data sets seen (SELECT-NEXT and SELECT-BEYOND), we believe ABBV’s efficacy is more compelling than LLY’s bari on a placebo adjusted basis as demonstrated in exhibit 7 and 8. GLPG’s Filgotinib phase 2 data was impressive and if reproduced in phase 3 (expected 2H18) it would be largely comparable to Upadacitinib’s profile but would be 1-2 years behind the others. We note that amongst the three players, ABBV has a distinct commercial advantage to LLY and GLPG/GILD given their experience and leadership presence in autoimmune , particularly in RA through the Humira franchise. In addition to leveraging a strong and experienced sales force and existing physician relationships, we could see them taking an innovative approach to bundling the autoimmune franchise when approaching payers. In contrast, LLY has a more limited presence and GILD/GLPG have no presence in the RA market.

Vertraagd	18 apr 2024 13:50
Koers	27,180
Verschil	-0,200 (-0,73%)
Hoog	27,300
Laag	26,940
Volume	64.147
Volume gemiddeld	80.458
Volume gisteren	104.556

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