Galapagos BE0003818359

Analyst reports 2020

1. avantiavanti 10 augustus 2020 12:02

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   Degroof Petercam 7 augustus 2020
   
   Galapagos (Buy from Hold) - 2Q20 results (EUR 158.5 / TP EUR 205 from EUR 223)
   
   Facts
   Revenues amounted to EUR 118m (Css. EUR 113m; DPe EUR 120m).
   OPEX increased 82% YoY, landing at EUR 204m (Css. EUR 172m; DPe EUR 182m), comprising EUR 149m in R&D, EUR 17m in S&M and EUR 38m in G&A.
   The company realized a net loss of EUR 86m (Css. EUR 93m net loss; DPe EUR 71m net loss).
   Cash & cash equivalents end of June stood at EUR 5,566m (Css. EUR 5,575m; DPe EUR 5,669m).
   The FY20 operational cash burn guidance of EUR 400m – EUR 430m was reiterated.
   After a pause in recruitment due to COVID-19 in DIVERSITY and PENGUIN - the ongoing filgotinib trials in Crohn’s disease and psoriatic arthritis - Gilead recently restarted recruiting patients at select sites, and enrollment into the MANTA and MANTA-RAy studies has been concluded.
   
   Outlook for second semester of 2020:
   Filgotinib: 1/ rheumatoid arthritis: following positive CHMP opinion, potential approval is anticipated 2/ ankylosing spondylitis: Phase III launch
   GLPG1972 (collaboration with Servier): Phase IIb topline in osteoarthritis (OA)
   GLPG1205: PINTA Phase II topline in idiopathic pulmonary fibrosis (IPF)
   GLPG1690 (ziritaxestat): NOVESA Phase IIa topline in systemic sclerosis (SSc)
   Toledo: launch of `3970 exploratory Phase II trials with anticipated readout 1H21
   The company is hosting a conference call today at 14:00 CET.
   
   Our view – Steep increase in OPEX YoY
   We observe a steep increase in OPEX YoY. Based on the latter, we took the liberty to factor in a higher of level of future OPEX projections to better reflect the company’s anticipated transition into a biopharmaceutical entity as well as the higher level overhead costs due to a continuously expanding (pre)clinical R&D efforts.
   
   Expected newsflow for 2020 remains on track:
   The most significant milestone will be the regulatory feedback on filgotinib for treatment of moderate-to-severe rheumatoid arthritis (RA) expected in the upcoming months. Based on the solid Phase III data package, our model assumes approval and potential peak sales of EUR 3,361m.
   GLPG1972: our 50% success rate in OA is relatively bullish and to a large extent implies a positive outcome of the ongoing Phase IIb trial.
   Both GLPG1205 and ziritaxestat being evaluated in exploratory Phase IIa trials in IPF and SSc, respectively, we consider the most substantial value-inflection for these indications to occur after positive readout in larger, qualitative follow-up trials.
   
   Investment conclusion
   We value Galapagos using an rNPV (WACC: 11%). After adjusting OPEX projections, cash position and outstanding shares, our PT arrives at EUR 205. We acknowledge that our SOTP valuation might pose some downside risk, given our relatively high success rate attribution to mid-to-late-stage programs. However, GLPG shares dropped substantially the past couple of months, what we consider to be an overreaction by the market, driven by Covid-19-related share price volatility and the Phase III readout of filgotinib in ulcerative colitis (UC). The latter was not perfect but still competitive with other JAKi’s being evaluated/approved in UC in our view. At current, lowered share price levels, we believe the long-term upside potential outweighs the downside risk. This is further supported by the company’s strong cash position, providing financial firepower to feed the development of (pre)clinical assets we currently do not yet include in our SOTP. We therefore upgrade to Buy.
2. wijzerplaat 10 augustus 2020 13:12

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   Thans avantiavanti!
3. avantiavanti 10 augustus 2020 13:22

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   H.C.Wainwright&CO 10 augustus 2020
   
   Rating: Buy; Price Target: $270.00
   
   2Q20 Update; Looking Beyond Filgotinib to Other Pipeline Readouts During 2H20

   Bijlage:
4. Broer Konijn 10 augustus 2020 18:14

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   En terwijl de afslachting van het aandeel Galapagos gewoon door gaat knalt ook Barclays er een koopadviesje tegen aan. Maakt niks uit, dalen doet 't toch wel........
   
   Zucht, vriendelijke groet Broer Konijn
   =====
   
   Analistenadviezen
   DATUM ANALIST ADVIES KOERSDOEL
   10:31 Barclays Capital kopen 210,00
   10:31 H.C. Wainwright & Co. kopen 0,00
   09:32 KBC Securities houden 192,00
5. Broke-r 10 augustus 2020 20:59

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   In elk geval fijn dat er weer koopadviezen doorsijpelen.
6. Piddy 11 augustus 2020 10:04

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   Mooi terras zeg ! De moeite.
   
7. Broer Konijn 11 augustus 2020 10:26

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   Uit het augustus draadje van Anton080.
   
   Mvg Broer Konijn
   ===
   
   Anton8080 schreef op 11 augustus 2020 09:55:
   
   (ABM FN-Dow Jones) Barclays heeft het koersdoel voor Galapagos verlaagd van 235,00 naar 210,00 euro, bij een ongewijzigd Overwogen advies. Dit bleek dinsdag uit een analistenrapport van de zakenbank.
   
   Het koersdoel werd verlaagd vanwege de hogere operationele kosten die de Britse bank voorziet.
   
   ?Het advies bleef gehandhaafd op Overwogen vanwege de aanhoudende vooruitgang met filgotinib in de VS.
   
   Volgens de analisten bevatten de recente kwartaalcijfers en de daaropvolgende toelichting door Galapagos weinig nieuwe informatie, wat de bank als positief beschouwt.
   
   “Het is een nare zomer voor het aandeel Galapagos,” concludeerden de analisten van Barclays.
   
   Het aandeel doet het sinds de publicatie eind mei van SELECTION-data duidelijk minder goed dan sectorgenoten.
   
   Het aandeel Galapagos steeg dinsdag 2,5 procent tot 158,70 euro.
   
   Door: ABM Financial News.
   info@abmfn.nl
   Redactie: +31(0)20 26 28 999
8. Broer Konijn 17 augustus 2020 12:29

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   Van IEX. Mvg Broer Konijn
   ===
   
   Morgan Stanley herhaalt het houdadvies voor Galapagos
   maandag 17 augustus 2020 - 08:58u -
   
   Morgan Stanley herhaalt het houdadvies van 11 aug 2020 voor Galapagos. Het houdadvies van dinsdag 11 augustus 2020 wordt herhaald. Dit vorige advies heeft geresulteerd in een rendement van 1,03%.
   Fonds: Galapagos Guru: Morgan Stanley
   Advies: Houden Status: Actief
   Koersdoel: - Score: 0,00%
   Startkoers: € 157,95 Huidige koers: € 157,10
   Verw. rendement: - 17 augustus 2020 - 12:04u
9. avantiavanti 19 augustus 2020 07:46

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   Extract Morgan Stanley 19 augustus 2020
   
   Filgotinib CRL A Surprise; Male Reproductive Toxicity Study and 200mg risk/benefit Key Issues
   
   North America
   Industry View In-Line
   
   Matthew Harrison, Connor Meehan, Thomas F Lavery, J.D.
   August 19, 2020
   
   FDA does not approve filgotinib citing need for MANTA data (due in 1H21) and risk/benefit with 200mg dose: FDA has requested data from the MANTA and MANTA-RAy trials, both of which are fully recruited and ongoing, and are intended to evaluate filgotinib's effect on reproductive health in male participants. Mgt. expects to report topline results from the MANTA and MANTA-RAy studies in 1H21 (we believe the 26 week data is likely required for re-filing and could be available in early 2021). The FDA also cited a second issue, unrelated to MANTA, concerning the risk/benefit of the 200mg dose. Review is ongoing in Japan, and mgt. expects a response from Japanese regulators by YE20. As a reminder, filgotinib received a positive opinion from CHMP (Committee for Medicinal Products for Human Use) at both dose levels in July (note here). Galapagos is due $75M on approval in the EU and $30M on Japan approval. Galapagos has increased its cash burn by $100M to account for the lack of the US approval milestone from Gilead. As summarized in our prior scenario analysis, available here, we see GLPG down 10%+ (~20% of EV) and GILD down 3%+ as a result of these events.
   
   We spoke with both Gilead and Galapagos. Key takeaways include: (1) Mgt. has provided FDA with blinded interim data from the MANTA studies, but FDA indicated it needs the complete unblinded data to evaluate filgotinib; (2) On the 200mg dose, mgt. characterized the issue as relating to the overall safety profile versus 100mg. Mgt. indicated that FDA was not focused on any specific safety imbalance. Further mgt. indicated that there was not a 'surprise' event in the safety database which caused FDA concern, rather the FDA concern is similar to the scrutiny higher doses of other JAK inhibitors faced. Mgt. does not see a read-through to potential approval of 200mg in UC given different divisions evaluate the drug; (3) Mgt. will have add'l safety follow-up from DARWIN3 and FINCH4 which could be used to better characterize the safety profile of 200mg for refiling; (4) Gilead mgt. acknowledged that the 200mg dose is important to the commercial profile of filgotinib in a very crowded class and that it may have to re-evaluate its filgotinib strategy if it cannot receive approval for the 200mg dose in RA. Mgt. highlighted that it will be disciplined with its commercial investment; (5) Mgt. will request a meeting with the FDA in the near-term to more clearly understand FDA's concerns and what data is needed to refile. Currently mgt. would anticipate refiling after MANTA data is available, but can't confirm a specific timeline until meeting with FDA (i.e., FDA could ask for longer than 26 weeks of follow-up from MANTA/RAy).
10. avantiavanti 19 augustus 2020 07:58

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    Extract Jefferies mbt Gilead
    
    Filgotinib CRL A Surprise; Male Reproductive Toxicity Study and 200mg risk/benefit Key Issues
    
    Michael Lee
    August 19, 2020
    
    Gilead Sciences, Inc. (GILD)
    BUY, $69.06 PT: $78.00
    
    CRL for filgotinib is a setback given it was a key growth driver and $2B+ peak consensus. On the other side, we don't think expectations were super high for GILD against leader ABBV anyway and we've been saying there was some risk around 200mg high dose all along in reports/videos. We predict GILD will await more safety data in H1-21 but ultimately GILD could make tough decisions on FILG and will continue to increase focus on oncology (5 deals this year).
    
    FDA does not approve filgotinib citing need for MANTA data (due in 1H21) and risk/benefit with 200mg dose: FDA has requested data from the MANTA and MANTA-RAy trials, both of which are fully recruited and ongoing, and are intended to evaluate filgotinib's effect on reproductive health in male participants. Mgt. expects to report topline results from the MANTA and MANTA-RAy studies in 1H21 (we believe the 26 week data is likely required for re-filing and could be available in early 2021). The FDA also cited a second issue, unrelated to MANTA, concerning the risk/benefit of the 200mg dose. Review is ongoing in Japan, and mgt. expects a response from Japanese regulators by YE20. As a reminder, filgotinib received a positive opinion from CHMP (Committee for Medicinal Products for Human Use) at both dose levels in July (note here). Galapagos is due $75M on approval in the EU and $30M on Japan approval. Galapagos has increased its cash burn by $100M to account for the lack of the US approval milestone from Gilead. As summarized in our prior scenario analysis, available here, we see GLPG down 10%+ (~20% of EV) and GILD down 3%+ as a result of these events.
    
    We spoke with both Gilead and Galapagos. Key takeaways include: (1) Mgt. has provided FDA with blinded interim data from the MANTA studies, but FDA indicated it needs the complete unblinded data to evaluate filgotinib; (2) On the 200mg dose, mgt. characterized the issue as relating to the overall safety profile versus 100mg. Mgt. indicated that FDA was not focused on any specific safety imbalance. Further mgt. indicated that there was not a 'surprise' event in the safety database which caused FDA concern, rather the FDA concern is similar to the scrutiny higher doses of other JAK inhibitors faced. Mgt. does not see a read-through to potential approval of 200mg in UC given different divisions evaluate the drug; (3) Mgt. will have add'l safety follow-up from DARWIN3 and FINCH4 which could be used to better characterize the safety profile of 200mg for refiling; (4) Gilead mgt. acknowledged that the 200mg dose is important to the commercial profile of filgotinib in a very crowded class and that it may have to re-evaluate its filgotinib strategy if it cannot receive approval for the 200mg dose in RA. Mgt. highlighted that it will be disciplined with its commercial investment; (5) Mgt. will request a meeting with the FDA in the near-term to more clearly understand FDA's concerns and what data is needed to refile. Currently mgt. would anticipate refiling after MANTA data is available, but can't confirm a specific timeline until meeting with FDA (i.e., FDA could ask for longer than 26 weeks of follow-up from MANTA/RAy).
12. Lama Daila 19 augustus 2020 08:02

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    Avantiavanti, is bovenstaand extract van Morgan Stanley of Jefferies?
    Blijkbaar Morgan Stanley, want Matthew Harrison zit daar.
    
13. avantiavanti 19 augustus 2020 08:02

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    Stifel 18 augustus 2020
    
    Lowering Target Price To $155 On Filgotinib CRL; Calls Into
    Question Its Potential Differentiation Within The JAK Class

    Bijlage:
14. avantiavanti 19 augustus 2020 08:09

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    quote:

    Lama Daila schreef op 19 augustus 2020 08:02:

    Avantiavanti, is bovenstaand extract van Morgan Stanley of Jefferies?
    Blijkbaar Morgan Stanley, want Matthew Harrison zit daar.
    
    

    Goed gezien, gecorrigeerd
15. Lama Daila 19 augustus 2020 08:17

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    quote:

    avantiavanti schreef op 19 augustus 2020 08:09:

    [...]
    
    Goed gezien, gecorrigeerd
    

    Bedankt, maar nu nog 2 identieke alinea’s en zelfde titel in beide posts. Een cut&paste-foutje ?
    
16. avantiavanti 19 augustus 2020 08:29

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    quote:

    Lama Daila schreef op 19 augustus 2020 08:17:

    [...]
    Bedankt, maar nu nog 2 identieke alinea’s en zelfde titel in beide posts. Een cut&paste-foutje ?
    
    

    Dank Lama Daila, idd copy paste foutje. Sorry all. Hierbij de file met de volledige update van Jefferies mbt Gilead.

    Bijlage:
17. Wall Street Trader 19 augustus 2020 09:58

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    Bryan Garnier & Co Galapagos (Buy) PT EUR 175
    
    FV reduced to EUR175 but we are reiterating BUY rating
    We are reducing our FV from EUR215 to EUR175
    
    Highly surprising move from the FDA as Filgotinib receives CRL
    
    Kind of worst case scenario for filgotinib in the US
    
    Yesterday evening, Galapagos and its partner Gilead have announced that they have received a complete response letter (CRL) from the US FDA for filgotinib’s NDA. FDA is indeed requesting data from the safety studies MANTA and MANTA-RAy studies before completing its review of the NDA while raising concerns regarding the overall benefit/risk profile of the filgotinib 200mg dose. We see this development as all the more surprising considering that that the CHMP has just adopted a positive opinion for both two doses of filgotinib. On top of that we clearly understood in the past that full findings from those studies were not necessary for approval. We were expecting that they would have been submitted once completed as a post-approval requirement. Regarding the 200mg, we previously acknowledge that there was a risk that FDA would take a conservative approach and approve only the lower dose. We do believe that FDA concerns on the highest dose are potentially driven by testicular toxicity seen in earlier trials, and that positive results from both MANTA and MANTA-RAy will allow both doses to be approved. This current situation is definitely our worst case scenario for filgotinib in the US.
    

    Bijlage:
18. Wall Street Trader 20 augustus 2020 15:57

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    @ avantiavanti
    
    Can you post the KEMPEN Report what was released today?
    
    Preferably the full pfd report.
    
    Thanks in advance ;-)
    
19. avantiavanti 20 augustus 2020 16:58

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    Citi 19 augustus 2020
    
    Galapagos (GLPG.AS)
    Likely 2-Year Delay for US Filgotinib Changes Prospects. Market
    Reaction Overdone. Buy.
    
    Upgrade to Buy (High Risk) with PT €145 – corresponding to our revised SOTP
    valuation (Figure 2). We adjust our filgotinib 2025e sales in RA to €2bn from €3bn
    and total sales to €4bn from €6bn. Although we accept that filgotinib prospects in the
    US have changed, with almost guaranteed European approval and €80+ per share
    in cash, we believe the negative market reaction is overdone and we like the
    risk/reward at the current level.

    Bijlage:
20. [verwijderd] 21 augustus 2020 08:58

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    @Avantiavanti, wederom enorm grote dank voor het posten van rapporten hier!! AB!
    
    Ik, grotendeels stille lezer, heb hier enorm veel aan gehad gedurende afgelopen jaren en zo vast velen met mij.
21. [verwijderd] 21 augustus 2020 09:23

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    quote:

    avantiavanti schreef op 20 augustus 2020 16:58:

    Citi 19 augustus 2020
    
    Galapagos (GLPG.AS)
    Likely 2-Year Delay for US Filgotinib Changes Prospects. Market
    Reaction Overdone. Buy.
    
    Upgrade to Buy (High Risk) with PT €145 – corresponding to our revised SOTP
    valuation (Figure 2). We adjust our filgotinib 2025e sales in RA to €2bn from €3bn
    and total sales to €4bn from €6bn. Although we accept that filgotinib prospects in the
    US have changed, with almost guaranteed European approval and €80+ per share
    in cash, we believe the negative market reaction is overdone and we like the
    risk/reward at the current level.
    

    Dank voor het plaatsen!
    
    Weet iemand of en zo ja welke van onderstaand gearceerde updates we eventueel nog in dit derde kwartaal kunnen verwachten?
    
    Approval and launch of filgotinib (Europe)
    GLPG1972 Phase 2b data in OA (ROCCELLA)
    Phase 2 PINTA trial data (GLPG1205 in IPF)
    Potential NOVESA data from GLPG1690 in Systemic Sclerosis
    R&D Day likely in 4Q20 - TOLEDO mechanism disclosed