Galapagos BE0003818359

Analyst reports 2019

1. Wall Street Trader 29 oktober 2019 13:36

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   KBC Securities Galapagos (Buy) PT EUR 189
   
   The Front Row, Tom Simonts
   
   “Galapagos: MOR106 is less”
   

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2. Wall Street Trader 30 oktober 2019 10:21

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   Bryan Garnier & Co Galapagos (Buy) PT EUR 175
   
   Fair Value EUR175 vs. EUR180
   
   MOR106 stopped on lack of efficacy, marginal impact to our FV
   
   Next catalysts for GLPG includes 1/ R&D day on Nov. 14th, updates on the 2/ TOLEDO program and 3/ recruitment status for the ISABELA phase III programme for GLPG1690 in IPF by year-end, as well as 4/ filgotinib phase III results in UC in H1 2020.
   
   Found this article by simply searching for a specific key phrase in Google.
   
   

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3. Wall Street Trader 30 oktober 2019 17:53

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   Cantor Fitzgerald
   
   Rating: Overweight
   
   Price Target: $187
   
   Galapagos outlook unchanged after MOR106 discontinuation, says Cantor Fitzgerald Cantor Fitzgerald analyst Eliana Merle says she still expects a "strong" 2020 from Galapagos following the announcement that clinical development of MOR106 in atopic dermatitis has been stopped for futility. The analyst lowered her price target for the shares to $187 from $188 and reiterates an Overweight rating on the name. She thinks there was "limited investor credit baked in" for the MOR106 program and that Galapagos had relatively limited economics.
   
   Many clinical catalysts in 2020 are underappreciated for Galapagos, Merle tells investors in a research note.
   
   
4. avantiavanti 6 november 2019 07:35

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   Nomura Instinet 5 november 2019
   
   PT onveranderd op 209$ post q3
   
   Our Est vs. Consensus: Focus on Oppy in UC
   
   Ahead of R&D Day and ACR/ARP – Consensus
   
   View Underestimates Filgo in UC; Ph3 Data 1H20
   
   GLPG will present data in RA and PsA for filgo at ACR/ARP on Nov 8-
   13, followed by an R&D day on Nov 14 in NYC. At ACR/ARP, GILD/
   GLPG will present further FINCH2 analysis at the American College of
   Rheumatology, including pooled safety data (p. 7 for complete list of
   abstracts). However, we believe these near-term events have drawn
   attention away from the opportunity in ulcerative colitis US), which we view
   as an underappreciated source of potential upside (and less competitive
   filgo launch for GILD/GLPG). Ph3 data in UC from SELECTION1 is
   expected in 1H20; tofacitinib was approved in UC in 2018, which we view as
   derisking proof of efficacy for JAK inhibitors in this indication. The superior
   safety and tolerability of filgo should enhance market uptake, particularly in
   IBD where higher JAK doses appear to be required, and in the wake of
   renewed safety warnings on tofa’s label, which makes our estimates highly
   differentiated vs. consensus. See pp. 3-6 for a review on our market
   assumptions and estimates, as well as a comparison to consensus in UC,
   CD, and RA. We make minor updates to our model ahead of the R&D day;
   p.8. Reiterate Buy.
   
   Ulcerative Colitis Ph3 Data in 1H20: Consensus Underestimates
   Opportunity and Derisking, in Our View. SELECTION1 data in 1H20 is
   the next source of value for filgo, in our view. We believe the consensus
   view around this indication underestimates filgo’s potential to provide a safer
   JAKi option in light of ongoing Xeljanz safety scrutiny; Xeljanz was approved
   in UC (with broad label) in 2018, providing proof of efficacy for JAKi
   approaches in UC (and likely CD, in our view); pp. 3-6 for comparison.
   
   Next Up ACR/ARP Nov 8-13: Data in RA and PsA: Summary P. 7. The
   majority of GILD/GLPG’s presentations are related to subgroup analyses in
   FINCH2, pooled safety results from the three FINCH trials (NCT02889796,
   NCT02873936, NCT02886728), and LT safety from DARWIN-3
   (NCT02065700). GILD to submit NDA by YE19 in U.S.; p. 7 for abstract list.
   
   R&D Day Nov 14, Probably Still No Toledo Target. Mgmt. has previously
   indicated the Toledo target would be disclosed on the launch of Ph2
   programs (next year). Until then, we do not anticipate significant value of
   Toledo to be incorporated into GLPG’s share price.

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5. avantiavanti 11 november 2019 08:54

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   Samenvatting van Morgan Stanley update
   
   Galapagos NV (GLPG.O)
   Stock Rating Overweight
   Price Target $193.00
   
   Matthew Harrison, Connor Meehan
   November 11, 2019
   
   Filgotinib Safety Remains Supportive
   
   Filgotinib maintains clean safety profile in incremental datasets: Mgt. announced additional safety analyses from pooled data across the FINCH program and long-term follow-up form PhIIb studies. Pooled safety from PhIII continues to demonstrate low rates of major adverse cardiac events (MACE), herpes zoster virus, deep vein thrombosis (DVT) and pulmonary embolism (PE). Further, 156 week follow-up from the PhIIb studies, point to continued low rates of DVT/PE (0.1/pt-year in the MTX+filgotinib arm and 0 in the monotherapy arm), serious infections (0.9/pt-year in the combo arm and 2/pt-year in the monotherapy arm) and MACE (0.1/pt-year in both arms). Overall, we see safety as supportive and await further updates for a US filing by YE19.
6. [verwijderd] 11 november 2019 10:21

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   Ogh wat moet ik hier voor onzin gaan verkopen ! Nog een keer. Afgelopen jaar heb ik voor de kerst 1000 stukjes gekocht, maar ga ze tegen deze kerst toch maar verkopen Toch een kleinigheidje verdient.
7. avantiavanti 12 november 2019 12:03

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   Degroof Petercam 12 november 2019
   
   TP 181 euro
   
   Galapagos (Buy) – Additional filgotinib data at 2019 ACR/ARP Annual
   Meeting
   
   Facts – Several presentations on arthritis
   At the 2019 ACR/ARP Annual Meeting, Galapagos and Gilead present a total of 20 abstracts, including key efficacy and safety data on filgotinib in rheumatoid arthritis (RA).
   
   A subgroup analysis from the Phase III FINCH 2 trial evaluating once-daily doses of filgotinib 200 mg and 100 mg with stable dose of csDMARDs in patients who previously had an inadequate response to biologic DMARD therapy (bDMARD-IR) showed that both doses of filgotinib improved clinical outcomes versus placebo at Week 12, regardless of the number and mechanism-of-action (MOA) of prior biologic used. At Week 24, filgotinib consistently improved clinical outcomes in bDMARD-IR patients. Efficacy was not impacted by demographic and clinical baseline characteristics.
   
   Safety and tolerability of filgotinib as a monotherapy and in combination with MTX or csDMARDs were found to be favorable in a pooled safety analysis across the randomized, multicenter Phase III FINCH 1, 2 and 3 studies encompassing a total of 3,452 patients. Major adverse cardiac events (MACE), herpes zoster virus, deep vein thrombosis (DVT) and pulmonary embolism (PE) were low and well balanced with placebo groups. A separate analysis from the FINCH 2 trial suggests that filgotinib may not increase the incidence of anemia, thrombocytopenia or leukopenia.
   
   Data comprising 2,203 patient-years of exposure (PYE) with filgotinib from the Phase IIb, open-label extension DARWIN 3 study further demonstrated durable safety and efficacy of filgotinib (200 mg or 100 mg) monotherapy and filgotinib plus MTX. No new safety signals were observed through 156 weeks of treatment.
   
   Both companies also present long-term (52 weeks of treatment) safety data on filgotinib of a Phase II open-label extension study in patients with psoriatic arthritis (PsA). In addition, the companies reveal more information on the design of the recently initiated Phase III program in PsA. This comprises two trials, PENGUIN 1 and 2. PENGUIN 1 which will compare the efficacy and safety of filgotinib, adalimumab and placebo in approximately 1000 patients with active PsA who are naive to bDMARD therapy. PENGUIN 2 will measure efficacy and safety of filgotinib vs placebo in 390 patients with active PsA who have an inadequate response or are intolerant to bDMARD therapy. The primary endpoint of each trial is ACR20 response at week 12, with multiple secondary endpoints on signs and symptoms of PsA up to week 24 in PENGUIN 1, and week 16 in PENGUIN 2. Topline readout is expected in 1H22.
   
   Our view – Filgotinib clinical program still holds several potential value inflections in the future
   These additional data and subgroup analyses further support our positive view on filgotinib’s potential as a best-in-class oral JAKi treatment paradigm for RA. The next milestone ahead is regulatory approval in US, EU and Japan. As a small reminder, submissions have been filed in Europe and Japan, NDA submission to the US FDA is anticipated by year-end. We anticipate regulatory feedback and potential market launch in 2H20. We allocate success rate of 95% for filgotinib in RA.
   
   In 2Q20, the first Phase III readout for filgotinib in inflammatory bowel disease (IBD) is expected, more specifically for the SELECTION trial in ulcerative colitis (UC). With AbbVie’s rival JAKi Rinvoq reading out in Phase III only in 2021, filgotinib holds an important time-to-market advantage in UC. We allocate a success rate of 63% to the UC program. The second Phase III readout in IBD is for the DIVERSITY readout in Crohn’s disease (CD), expected in 2021. Compared to UC, CD represents a slightly larger market opportunity as more patients are on active treatment. Based on the positive results obtained in the Phase II FITZROY trial, we allocate a success rate of 68% to the CD program.
   
   Furthermore, we are encouraged by the recent launch of the Phase III PENGUIN trials in psoriatic arthritis (PsA), as the latter represents subtnantial additional market opportunity for filgotinib. We allocate a success rate of 68% to the PsA program. A more or less similar market opportunity could arise for filgotinib ankylosing spondylitis (AS), for which the company anticipates the Phase III launch next year. We allocate a success rate of 57% to the AS program.
   
   Investment conclusion
   We maintain our Buy rating.
8. *voetnoot 12 november 2019 13:36

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   Dank weer!
9. avantiavanti 15 november 2019 10:03

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   Morgan Stanley samenvatting
   
   2019 R&D Day Highlights Pipeline Beyond Filgotinib
   Stock Rating Overweight
   Price Target $193.00
   
   Matthew Harrison, Connor Meehan
   November 15, 2019
   
   R&D day highlights next wave of compounds and strategic focus: The R&D day focused on the continued development of clinical and pre-clinical assets in the metabolic, fibrotic, and inflammatory therapeutic spaces, along with additional color on timelines for newsflow in 2020, and details on Galapagos' intended strategic focus. Importantly, mgt's updates highlighted (1) developments in the Toledo program, such as preclinical data and an addition to the family of compounds; (2) progress thus far on GLPG1690 in IPF; (3) the intent to broaden the approach to drug discovery and target identification, leveraging the company's strong cash position, and; (4) a series of preclinical candidates (PCCs) that may represent the next wave of compounds to be evaluated in the clinic. Following filgotinib filing in the U.S., we see the next key focus as the Toledo program and GLPG1690 in IPF (ISABELA). The first Toledo readout will be topline data from GLPG3312 in UC during 2020. On ISABELA, mgt. extended the date of the futility analysis from 2H20 to 1Q21. The event webcast can be found here, and the slides here.
   
   Key Takeaways: (1) Mgt. provided an update on next steps and the planned strategic approach for the compounds in the Toledo program. In 2020, mgt. will focus exclusively on short proof-of-concept trials in inflammatory indications. In 2021, mgt. will pursue additional proof-of-concept trials and initiate dose-finding trials, followed eventually by expansion into indications beyond inflammation; (2) Mgt. did not disclose the Toledo mechanism, but noted that GLPG3312 has affinity for three targets (which it is calling TOL1, 2, 3), GLPG3970 for two targets (TOL2, 3), and newly-disclosed GLPG4399 is TOL3 selective; (3) Mgt. emphasized the large unmet need associated with IPF, and noted that there is room for improvement in both toxicity and efficacy beyond currently-approved treatments; (4) Mgt. extended the timeline associated with the upcoming interim futility analysis for GLPG1690 in IPF from 2H20 to 1Q21, driven by slower than expected recruitment. As a reminder, IPF studies require long time periods and a large numbers of patients to be enrolled; (5) In the ongoing PhIII ISABELA study, mgt. expects to finish collecting data on ~28% of patients by 4Q20, allowing for 1Q21 futility analysis, followed by topline data in early 2022; (6) As part of the ISABELA trial, GLPG1690 will be evaluated in combination with the standard of care. The study is powered to detect a difference of 80mL between placebo and drug, regardless of background treatment, and mgt. noted that in IPF, success may be considered stable disease; (7) Following the Gilead transaction, given the company's sizeable cash position, mgt expects to expand the drug discovery engine. This will include a series of strategic improvements: (a) enhancing the understanding of signalling pathways to better identify relevant targets, (b) addressing new therapeutic modalities by expanding the breadth of the drug discovery engine, and (c) incorporating patient data, specifically from patients who have not responded to otherwise-successful drugs; (8) On new modalities, mgt. intends to expand the R&D pipeline to include compounds that interfere with RNA translation (RNAi), such as oligonucleotides, and enhance protein degradation, such as PROTACS. Both of these approaches will also include small molecules, and roll-out of this expansion will be over the course of the next few years; (9) As part of the R&D expansion, mgt. intends to increase the number of genes that are screened for therapeutic targets from 6,000 to 25,000 by 2025; (10) Mgt. reviewed the progress on the filgotinib program. Of note, indications beyond RA are expected to represent ~60% of the future global inflammation market by 2027. See our pulse from ACR here; (11) Mgt. also summarized its five newly-disclosed preclinical candidates: GLPG4059 (may have potential in metabolic disorders, see data below), '4124 (a novel MoA for fibrosis, in the clinic 2021), '4259 (a back up inflammatory asset), '4399 (3rd Toledo compound, has demonstrated potential in joint models), and '4471 (back up).
   
   Strategic focus aligns with both near and long term growth objectives: We see the R&D expansion strategy as supportive of Galapagos' long-term mission to deliver an integrated biopharma organization, and an expected use of cash from the Gilead transaction. We continue to see regulatory decisions on filgotinib in RA are key near-term value driver, with initial Toledo data, filgotinib data in UC and PhII OA data as the key 2020 drivers.
   
   Mgt. also provided an update on expected newsflow for 2020, summarized below:
   
   Bijlage: Key Newsflow for 2020
   
   

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10. avantiavanti 15 november 2019 10:09

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    Degroof Petercam 15 november 2019
    
    TP 181 euro
    
    Galapagos (Buy) – Main takeaways from annual R&D day
    
    Yesterday, Galapagos hosted its annual R&D update. Speakers were the company’s CSO, CMO, CFO and the principal investigator (PI) Prof. Toby Maher, who coordinated the Phase IIa FLORA trial of GLPG1690.
    
    Facts - Focus on R&D platform, Toledo, filgotinib and IPF
    R&D platform. The event was kicked off by more insight on the discovery platform and preclinical pipeline. Inflammation, fibrosis and metabolic disease will be the company’s main focus areas of future R&D efforts. The company will further boost its drug discovery potential by expanding the gene screening pool from 6,000 to 20,000 genes by 2025. In terms of drug types, the company will remain focussed on developing small molecules and will also look into oligonucleotides. The company currently holds five preclinical assets. Animal data indicating potential in type-2 diabetes were shown for one of these candidates, the lipid modulator GLPG4059.
    
    Toledo. An update was provided on the company’s largest early-stage program Toledo. Three Toledo candidates have been reported so far. Each have different selectivity profiles towards the yet undisclosed target, currently named ‘TOL’. First generation GLPG3312 seems to engage all TOL targets, while 2nd and 3rd generation GLPG3970 and GLPG4399 are TOL2/3- and TOL3-selective, respectively. GLPG3312 demonstrated promise in inflammatory bowel disease animal models, while GLPG3970 generated robust efficacy in arthritis and osteoporosis animal models. Both GLPG3312 and GLPG3970 are currently undergoing Phase I evaluation. In 2020, the company intends to initiate several exploratory Phase II proof-of-concept studies.
    
    Filgotinib. An overview was provided on the filgotinib clinical pipeline, with rheumatoid arthritis (RA), ulcerative colitis (UC), Crohn’s disease (CD), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) regarderd as key indications. In each of the latter, Galapagos is in a position to be the first or second JAK-inhibitor on the market. In light of the recent initiation of Phase III PENGUIN trial in PsA, the company emphasized on filgotinib’s durable efficacy and safety observed in the Phase II EQUATOR trial, which suggests consistent performance of filgotinib across several indications. The company repeated its hypothesis on the advantages of filgotinib’s selectivity towards JAK1-inhibition and functional preservation of JAK2 and JAK3.
    
    IPF. PI Prof. Toby Maher provided a clinician’s perspective on idiopathic pulmonary fibrosis (IPF), more specifically on the severe, progressive nature of the disease, the steeply increasing incidence and the clinical performance of the two approved drugs pirfenidone and nintedanib. The company’s CMO further highlighted the limitations of current IPF treatments in scope of only being capable of slowing down the decline of forced vital capacity (FVC) and exerting poor tolerability leading to treatment discontinuation. More insights were provided on GLPF1690’s Phase III program ISABELA, comprising 1500 patients across two identical trials, each evaluating two doses of GLPG1690 on top of standard of care (SOC) versus SOC alone. This program has a futility analysis, which requires 500 patients to reach the 52-week treatment duration mark. The latter is anticipated for 1Q21 based on current recruitment rate. Topline readout is expected in early 2022.
    
    Our view – Full steam ahead on all levels
    
    The R&D day clearly indicated that the company will further intensify its R&D development efforts with the objective to launch one Phase III trial every year while in parallel being in full launch mode for filgotinib. This will guarantee an abundance of newsflow in the upcoming years containing various potential valuation catalysts, including the approval and commercial launch of filgotinib in RA, the Phase III readout of filgotinib in UC and topline Phase IIb data of GLPG1972 in osteoarthritis in 2020. We maintain our Buy rating.
    
    
12. avantiavanti 15 november 2019 10:15

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    Kempen 15 november 2019
    
    Galapagos - R&D day highlights: IPF phase III futility analysis in Q1'21
    GLPG NA - Close: €166.80 - BUY, PT: €180.00, alex.cogut@kempen.com
    
    Galapagos held its R&D update yesterday, where it provided an update on key pipeline programs. Overall there was limited new information apart from the timing of the GLPG1690 phase III futility analysis now expected in Q1'21, which in our view rather de-risks the stock next year as it will largely be driven by filgotinib UC phase III data in Q2'20 and FDA approval and launch in RA in H2'20. There were scant details about R&D expansion with simple mentions of new disease areas (metabolic, polycystic kidney disease and hepatitis B) and new drug modalities (oligonucleotides and PROTACs). Given no concrete roadmap was presented, we don't see any near-term impact on valuation apart from cash burn on internal R&D and potential acquisitions. Bottom line, we believe the share price now fairly accurately incorporates the recent Gilead deal and with limited newsflow till YE'19, we remove Galapagos from our favorites list.
13. Wall Street Trader 15 november 2019 10:58

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    Berenberg (Buy) PT EUR 195
    
    Op 15 november 2019 hebben de analisten van Berenberg hun beleggingsadvies voor Galapagos herhaald.
    Het advies van Berenberg voor Galapagos blijft "kopen".
    
    Het koersdoel wordt door Berenberg verlaagd van 200,00 EUR naar 195,00 EUR.
    
    KBC Securities Galapagos (Buy) PT EUR 189
    
    Galapagos hield gisteren zijn R&D dag in New York, waar de klinische ontwikkelingsplannen van
    Filgotinib in Psoriatische Artritis (PsA) en 1690 in IPF en zijn vroege ontwikkelingspijplijn werden uitgewerkt. Twee elementen van belang waren de nieuwe verbinding '4059, gepositioneerd in Type 2 Diabetes (T2DM) en de derde, de meest specifieke Toledo verbinding '4399. KBCS concludeert dat Galapagos zich duidelijk op Toledo richt. Dat onderzoek is in een vroeg stadium op het gebied van leverziekten en -metabolica (NASH) en is zeer complementair aan de activiteiten van Gilead. Geen impact op 189 euro koersdoel en “Kopen”-advies.
    
    
14. Wall Street Trader 15 november 2019 14:26

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    Galapagos (GLPG) Receives a Buy from Cowen & Co.
    
    November 14, 2019
    
    In a report released today, Phil Nadeau from Cowen & Co. maintained a Buy rating on Galapagos (GLPG). The company’s shares closed last Monday at $183.80, close to its 52-week high of $192.89.
    
    www.markets.co/galapagos-glpg-receive...
    
    
15. Wall Street Trader 18 november 2019 14:55

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    RBC Capital Sector Perform Price Target $158
    
    Sector Perform (SP): Returns expected to be in line with sector average over 12 months.
    
    Galapagos price target raised to $158 from $152 at RBC Capital.
    
    Galapagos, Gilead analyst commentary at RBC Capital Galapagos price target raised to $158 from $152 at RBC Capital. RBC Capital analyst Brian Abrahams raised his price target on Galapagos (GLPG) to $158 after the company's R&D day, where the management revealed its "expansive plans for bringing new discovery techniques, treatment modalities, preclinical assets, and targeted indications online" by using the cash from its recent Gilead (GILD) deal. While these "aspirations" will take time to mature, the analyst says the plans are "impressive". Abrahams still keeps his Sector Perform rating on Galapagos shares, noting that its nearer term positives of filgotinib commercialization in RA and potential expansion into IB look priced in.
    
    
16. avantiavanti 18 november 2019 17:34

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    Goldman Sachs samenvatting
    
    €108.00 (edit: nee geen typefout...)
    12M PRICE TARGET
    
    Galapagos NV (GLPG.AS): R&D Update: Toledo continues to intrigue as future R&D vision begins to emerge, but IPF P3 interim pushed to 1Q21
    
    18 November 2019 | 4:55AM EST
    What's new: We attended GLPG's annual R&D Update event last week, with topics discussed largely as we expected (see our previous note). The key headline coming out of the event, in our view, was a delay in the timing of the Phase 3 interim/futility analysis for GLPG1690 (for IPF) from early 2H20 to 1Q21. Beyond that, we were most interested in (1) GLPG's stealthy Toledo program (mechanism of action still unknown, but to be disclosed in 2020, along with first clinical data), (2) GLPG's interest in expanding beyond small molecules and into RNA-based approaches (which makes sense to us, given the companies interest in fibrosis and NASH), and (3) a key opinion leader-led discussion on IPF.
    
    Bottom line: We came away from the event generally positive, and admittedly, we continue to be impressed by the overall progress GLPG is making. That said, given stock's 26% bounce since the Gilead deal was announced (and its +100% performance YTD), we believe current investor enthusiasm may begin to temper, especially after formal inclusion of GLPG in the MSCI index on Nov. 26 (we believe market buying ahead of that has been partially responsible for recent stock strength). As such, maintain Neutral.
    
    
17. BLOO7 18 november 2019 18:03

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    quote:

    avantiavanti schreef op 18 november 2019 17:34:

    Goldman Sachs samenvatting
    
    €108.00 (edit: nee geen typefout...)
    12M PRICE TARGET
    
    Galapagos NV (GLPG.AS): R&D Update: Toledo continues to intrigue as future R&D vision begins to emerge, but IPF P3 interim pushed to 1Q21
    
    18 November 2019 | 4:55AM EST
    What's new: We attended GLPG's annual R&D Update event last week, with topics discussed largely as we expected (see our previous note). The key headline coming out of the event, in our view, was a delay in the timing of the Phase 3 interim/futility analysis for GLPG1690 (for IPF) from early 2H20 to 1Q21. Beyond that, we were most interested in (1) GLPG's stealthy Toledo program (mechanism of action still unknown, but to be disclosed in 2020, along with first clinical data), (2) GLPG's interest in expanding beyond small molecules and into RNA-based approaches (which makes sense to us, given the companies interest in fibrosis and NASH), and (3) a key opinion leader-led discussion on IPF.
    
    Bottom line: We came away from the event generally positive, and admittedly, we continue to be impressed by the overall progress GLPG is making. That said, given stock's 26% bounce since the Gilead deal was announced (and its +100% performance YTD), we believe current investor enthusiasm may begin to temper, especially after formal inclusion of GLPG in the MSCI index on Nov. 26 (we believe market buying ahead of that has been partially responsible for recent stock strength). As such, maintain Neutral.
    
    

    Altijd al een stelletje schurken geweest.
    
    blog.oup.com/2012/03/goldman-sachs-op...
18. avantiavanti 18 november 2019 18:10

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    • avantiavanti

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    Goldman Sachs: het geheel.
    
    De updates van GS laten zich wat lastig delen. Ik heb dus de tekst gekopieerd. Daardoor ziet het er wat rommelig uit
    
    R&D Update key takeaways
    
    Coming out of the R&D Update, the below captures what we found to be key
    takeaways:
    On current progress: Since the last R&D Update last year, new targets have been
    identified in inflammation, metabolic disease, fibrosis, and OA (with several new lead candidates specifically called out, see below), while several new POC’s have been initiated (PINTA for ‘1205 in IPF, and NOVESA for ‘1690 in systemic sclerosis), as well as a new Phase 3 program, PENGUIN 1 and 2 for filgotinib in psoriatic arthritis.
    In terms of where GLPG spends on R&D, not surprisingly, the majority goes to
    inflammation and fibrosis (together, 57%), while we were surprised to hear that 18% goes to R&D on metabolic diseases (such as diabetes), 5% goes to polycystic kidney disease (new to us). We’ll continue to monitor the situation closely. We note that GLPG discussed GLPG4059, noting that it featured a novel MOA that does not hit triglycerides, and preclinical data demonstrated lowering of blood glucose, with favorable effects also on hemoglobin HbA1c and body weight.
    
    On Toledo: This represents GLPG’s biggest program in terms of the discovery and early development efforts. The MOA is novel, and as stated earlier, GLPG did not reveal any specifics at the R&D Update, and instead plans to disclose further details in 2020.
    However, of particular interest, GLPG disclosed the following about its now three Toledo compounds:
    n ‘3312 (first generation) is a pan-TOL compound, hitting what was referred to as TOL1, TOL2, and TOL3 n ‘3970 (second generation) hits TOL2 and TOL3 (i.e., is TOL2 and TOL3 selective); a Phase 1 started in 2019, and a broad Phase 2 development program (will include multiple Phase 2 POC studies) will begin in 2020; potential trials to begin in 2021 exploring utility beyond inflammation
    n Newly disclosed ‘4399 (third Toledo candidate) is TOL3 selective
    Exhibit 1: New preclinical candidates: GLPG’s potential next wave of innovation
    Candidate Comment
    GLPG4059 Novel MOA for Type 2 diabetes, will enter Phase 1 in 2020
    GLPG4124 Novel MOA for fibrosis
    GLPG4259 Backup for inflammation
    GLPG4399 3rd Toledo compound
    GLPG4471 Also a backup compound
    
    Future directions: In what we found to be an intriguing discussion, GLPG announced plans to expand its list of potential targets from the current 6,000+ that are druggable by small molecules to 20,000+ that are encoded by genes by 2025. It intends to do so by
    (1) expanding its scientific interests to pathways and more broadly networks, (2) layering
    in a greater reliance on patient data and new technology (such as single cell
    sequencing); and (3) using newer modalities. Here, in addition to its traditional small molecule approaches, GLPG will also now look to develop oligomernucleotide (i.e.,RNA-based) candidates in order to knock down levels of aberrant protein expression and also a novel PROTACS (proteolysis-targeting chimeras) candidates which are small molecules that can induces rapid degradation.
    It remains unclear to us whether GLPG will be successful in its endeavor to develop RNA-based approaches, but we note that given the company’s previous interest in hepatitis B and current interest in NASH (where the target organ for both is the liver, where RNA-based approaches appear to have some modicum of success), we’re eager to see what emerges over the next several years, and we await next developments to be able to assess the feasibility and tractability of
    GLPG’s efforts going down this road.
    Filgotinib and operational update: GLPG reminded of its ambitions for filgotinib
    beyond the initial indication of rheumatoid arthritis (RA):
    n Ulcerative colitis (UC): Top-line Phase 3 data in 2Q20
    n Crohn’s disease (CD): Phase 3 still recruiting (we believe this program is running at least one year behind that of the UC program)
    n Psoriatic arthrits (PsA): the Phase 3 PENGUIN 1 (patients with inadequate response to methotrexate/MTX) and PENGUIN 2 (patients with inadequate response to biologic agents) studies are just beginning to enroll and will explore two doses (100/200mg)
    
    Ankylosing spondylitis (AS): preparations to initiate a Phase 3 pivotal program are underway . Other indications also being explored.
    GLPG reminded us that the global inflammation market is large (expected to be $65bn by 2027, according to their estimates), with indication beyond RA expected to comprise c.60% of the market. Beyond that, however, we learned little new about filgotinib, and further when asked about the status of the ongoing MANTA and MANTA RAy studies and what would be submitted to support the expected new drug application (NDA) for filgotinib, GLPG (perhaps given that partner GILD controls official communications) added little, if anything, new. That said, we believe it is nonetheless key to remind that safety data from neither MANTA and MANTA-RAy are needed to support the NDA filing.
    
    
19. avantiavanti 18 november 2019 18:11

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    • avantiavanti

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    Vervolg GS
    
    From an operational perspective, GLPG leadership provided a brief overview of the amended filgotinib terms and the overall plans to make GLPG a fully, integrated global biotechnology company, with the company expected to launch the drug for RA in France, Italy, Spain and the Benelux countries sometime in 2H20 and then in 2H21,
    GLPG plans to launch filgotinib in UC in the UK, Germany and again, the Benelux
    countries.
    
    KOL discussion of IPF ... In a surprise to us, GLPG brought in an IPF KOL from the UK who oversees 5,000 pulmonary fibrosis patients, and also sees about 1500 new patients each year. With respect to severity and seriousness of IPF, he reminded us that:
    n c.40-50,000 are diagnosed in the US each year; there are an estimated 250,000
    patients with IPF now in the US (so technically not an orphan disease), with a
    doubling to 500,000 estimated by 2030.
    n Median survival of a patient diagnosed with IPF is c.2-3 years, and while there now are two currently approved drugs (Roche’s Esbriet and Boehringer Ingelheims’ Ofev, which were both approved in the fall of 2014 and that on a combined basis, has generated over $2bn in 2018), there is still a significant need given the limitations of Ofev and Esbriet on both efficacy and tolerability (GLPG cited 25% discontinuations).
    Patients display three forms of disease progression, so there is some variability in the IPF disease phenotype.
    And the potential of GLPG1690 in IPF: GLPG1690 is a small molecule inhibitor of
    autotaxin, which is the main source of LPA in the blood. Key takeaways on ‘1690 in our view, were: (1) the futility outcome is now expected in 1Q21 (vs. a prior summer 2020) due to a recalculation of the powering assumptions, representing a delay; (2) top-line Phase 3 data are expected in the early part of 2022; (3) the mechanism is believed to block LPA production and transport; (4) the autotaxin/LPA approach has been previously validated, via a Bristol-Myers Squibb (covered by Terence Flynn) candidate (BMS-986020), which ultimately lead to significant off-target toxicity, and therefore was discontinued.
    
    A word on our model
    We note that there are several sensitivities that result in risks to our estimates mainly toaccount for the newly expanded relationship with Gilead and the various pushes and pulls arising from the deal. Positives include $5bn in new cash on the balance sheet, new potential up-front and milestone payments associated with GILD opt-ins for GLPG pipeline candidates, and GLPG’s recording of filgotinib-related revenue in Spain, Italy and France (represents an expansion beyond GLPG’s original commercial rights in the
    Benelux countries); offsets include the capping of the potential upside from the IPF franchise (i.e., GLPG now stands to receive a sales royalty vs. prior recording of 100% of the revenue), and added cost-sharing for filgotinib.
    In addition, other pushes and pulls for our GLPG model are revenue-related and
    potentially include: (1) addition of other GLPG candidates (e.g., GLPG1972 for
    osteoarthritis/OA, and Toledo franchise, though both have yet to demonstrate clinical proof-of-concept); (2) potential removal of filgotinib revenue from Sjogren’s syndorme and lupus, given recent negative Phase 2 proof-of-concept readouts; and (3) potential adjustment of overall filgotinib revenue given what we believe could now be an increased likelihood of a class label (and hence, black-box warning) for filgotinib that may ultimately result in lack of competitive differentiation.
    
    Exhibit 2: With the interim Phase 3 analysis for ‘1690 pushed to 2021, we next look to ‘1205 Phase 2 data in IPF and ‘1972 Phase 2b data in OA.
    
    Timing Product Event Type Details
    2019
    4Q19 filgotinib Regulatory Submit NDA in RA (by partner Gilead)
    2H19 ’2534 Clinical Initiate Phase 1 study
    2020
    1Q20 filgotinib Clinical Initiate Phase 3 trial in ankylosing spondylitis (AS)
    2Q20 filgotinib Clinical Fully enroll Phase 3 DIVERSITY trial in Crohn’s disease (CD)
    1H20 filgotinib Clinical Announce Phase 3 SELECTION data in UC
    1H20 filgotinib Clinical Announce Phase 2 data in lupus membranous nephropathy
    1H20 ’2534 Clinical Announce Phase 1 data
    1H20 ’3312 (1st gen Toledo) Clinical Initiate Phase 2 trial in UC
    2H20 ’1205 Clinical Announce Phase 2 PINTA data in IPF
    2H20 ’1690 Clinical Announce Phase 2 NOVESA data in systemic sclerosis
    2H20 ’1972 Clinical Announce Phase 2b ROCCELLA data in OA
    2H20 filgotinib Clinical Announce Phase 2 MANTA data in UC
    2H20 filgotinib Regulatory Potentially submit sNDA in UC
    2H20 filgotinib Clinical Announce Phase 2 data in small bowel CD
    3Q20 filgotinib Regulatory Potential EU approval in RA
    2H20 filgotinib Commercial Launch in France, Italy, Spain and Benelux countries for RA
    4Q20 filgotinib Regulatory Potential US approval in RA
    4Q20 filgotinib Commercial Potential US launch in RA
    2020 ’3312 (1st gen Toledo) Clinical Announce topline Phase 1 data
    2020 ’3312 (1st gen Toledo) Clinical Announce topline Phase 2 data in UC
    2020 ’3970 (2nd gen Toledo) Clinical Initiate multiple short Phase 2 POC trials
    2020 ’4059 Clinical Initiate Phase 1 trial in healthy volunteers
    2020 ’4399 (3rd gen Toledo) Clinical Initiate Phase 1 trial in healthy volunteers
    2021+
    1Q21 ’1690 Clinical Announce futility analysis for Phase 3 ISABELA1 data in IPF
    1H21 filgotinib Clinical Announce Phase 2 data in fistulizing CD
    2H21 filgotinib Commercial Launch in UK, Germany, Benelux countries for UC
    2021 filgotinib Clinical Announce Phase 3 DIVERSITY data in CD
    2021 filgotinib Clinical Announce Phase 2 OLE data in psoriatic arthritis
    2021 filgotinib Clinical Announce Phase 2 data in uveitis
    2021 filgotinib Regulatory Potential FDA approval in UC
    2021 ’3970 (2nd gen Toledo) Clinical Initiate dose-finding studies, larger POC trials, trials beyond inflammation
    
    Valuation & risks
    We are Neutral rated on Galapagos with a DCF-derived 12-month price target of €108 (10% WACC and -10% terminal growth rate). Upside risks include: better than expected clinical data for pipeline products (such as filgotinib); better-than-expected market uptake of key products; contributions from earlier stage products not currently modeled.
    Downside risks include: negative clinical data for pipeline products; delays in
    development and/or regulatory timelines for key products (such as filgotinib;
    slower-than-expected market uptake for key products (such as filgotinib).
20. avantiavanti 18 november 2019 18:25

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    • avantiavanti

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    SVBLeerink 18 november 2019 samenvatting
    
    PT: $194,-
    
    R&D Day Displays Fruits of Innovative Spirit
    
    Bottom Line:
    GLPG showcased their capabilities and strategy during their R&D day, positioning themselves as a company with a pliable, productive platform, a deep pipeline, but more importantly a method and culture to their creative process promising much more to come. We reiterate our OP rating and $194 PT.
    
    Our Take.
    We spent considerable time with management after the R&D day presentations, as we hosted two days of meetings with GLPG management. We believe outside a few investors, the company is undervalued for its creativity, courage, and productivity. As Toledo’s identity remains speculative, we have not included its valuation in our models, but given the size of the effort from GLPG, we expect significant upside at the current valuations as we get to see the program in detail; perhaps even reinventing an entire class of therapeutics as the JAK inhibitors and the anti-cytokine biologics have. We remain sanguine about the prospects for success in their osteoarthritis program, given the enormity of challenge in the field, but we have also seen steady progress by the clinical academic community in using imaging to identify responder populations which can now be used for testing of a narrower responsive diseased population. While we have heard a lot of grumblings around the idiopathic pulmonary fibrosis (IPF) program and why GLPG did not perform a Phase 2b study, we also have noticed that many are quite ignorant of the pathway, the Bristol Myers parallel program, and the clear reasoning behind the jump from GLPG. In our view GLPG is in that sweet spot of growth and inflection that makes the company highly attractive. With ample cash, a careful management, a solid translational biology-based discovery platform, nothing they are doing has even the slightest whiff of "me too" science. Thinking 10-15 year horizons seems absurd in the biotech business, but in our view every move that GLPG has been making today has been, from a bird's-eye view, strategic to build a fully integrated company that in 15 years will likely be in the top 10 of biotech.
    
21. Geneve 18 november 2019 18:26

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    Re: GS koersdoel
    Ik snap er eerlijk gezegd niks van; hun rapport is redelijk optimistisch en verder stellen ze "neutraal rated" te zijn.
    En dan €108 als koersdoel? Dat klopt toch gewoon niet (zou een koersdaling van 40% impliceren) Is dit koersdoel wellicht exclusief cash en dus feitelijk een koersdoel van €194?