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Galapagos BE0003818359

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Analyst reports 2018

220 Posts
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  2. avantiavanti 20 april 2018 08:57

    • avantiavanti

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    GILD/GLPG: Despite FDA's Bari Criticisms, No Change To Our View On Filgotinib


    April 19, 2018

    RBC Capital Markets, LLC
    Brian Abrahams (Analyst) (212) 858-7066; brian.abrahams@rbc.com



    FDA briefing documents were posted this morning for the upcoming baricitinib AdComm and show significant debate within the agency on the benefit/risk of that drug (see our note here) - recall GILD/GLPG's filgotinib is in the same general Jak inhibitor class and is also being tested in RA (as well as other diseases). Despite this scrutiny, we do not see major read-throughs either way for filgotinib-- on one hand, reviewers made a point that thrombosis is likely not a class effect, suggesting they will consider each drug's profile individually, though on the other hand, the documents do highlight the high safety bar in RA. Approval of bari at only its lower 2mg dose would reduce its RA competitiveness and could improve filgotinib's commercial positioning (though filg could get the same treatment by Agency); also, we note benefit/risk of filg would likely be less scrutinized in IBD (which accounts for ~2/3 of our out-year prob-adjusted $3.2B sales estimate) anyway. We remain relatively positive on filgotinib's potential though we believe more optimism for the agent is already reflected in GLPG shares vs. GILD shares.

    On one hand, reviewers made the specific point that VTEs (thrombolic events) do not appear to be an overall class effect of JAK1/2 inhibitors. The documents specifically discussed differences in rates of adverse events between bari and tofacitinib, an approved JAK inhibitor for RA, speculating that differences in JAK selectivity could account for the imbalances seen. Filgotinib has not shown as significant imbalances in VTEs and has a more JAK1 selective profile vs. bari or tofa, and we believe the VTE question will not influence the FDA's views on filgotinib, and filgotinib will be evaluated solely based on the safety signals observed in its own clinical studies.

    On the other hand, given availability of treatment for RA including other JAK inhibitors, the FDA clearly does not consider RA an area of high unmet need, and any imbalances in this indication may be highly scrutinized. Even though the number of thromboembolic events in baricitinib clinical trials were low and did not reach the threshold of statistical significance, one of the reviewers remained highly concerned over the numerically higher number of thrombotic events in the baricitinib arm, which they comment is not seen in other approved RA therapies. We believe this reveals a high safety bar for approval in RA, and believe that any potential safety imbalances that could potentially emerge in filgotinib clinical trials would be given the same high level of scrutiny. We also note that, as we pointed out in our initiation reports on GLPG and GILD, this division tends to steer labels towards lower doses in RA.
  3. avantiavanti 24 april 2018 07:30

    • avantiavanti

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    BTIG 23 april 2018

    Galapagos N.V.
    Baricitinib’s AdCom Positive Readthrough for Selective
    Jak Inhibitors

    On Monday, the FDA convened an AdCom to discuss the approvability of
    baricitinib for the treatment of patients with moderate to severe
    Rheumatoid Arthritis (RA). Regarding the risk benefit profile, the advisory
    committee voted in favor of the 2mg dose (10 to 5) and not in favor of 4mg
    dose (5 to 10). The split of the votes somewhat mirrored the vote on safety,
    as the votes on efficacy were overwhelmingly positive for the 2mg (14 to 1)
    and 4mg (15 to 0) doses. We think the outcome bodes well for filgotinib,
    which has shown lower rate of venous thrombosis (the key safety concern),
    and we look forward to the next readout from Galapagos’ Phase 3 RA
    program in 2H2018. We reiterate our Buy rating and $118 PT.
    Bijlage:
  5. avantiavanti 24 april 2018 14:20

    • avantiavanti

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    Degroof Petercam 24 april 2018

    Galapagos (Buy) - Initiation of first triple combination trial in cystic fibrosis and evolutions in JAK inhibitor field (EUR 78 / TP EUR 98)

    Facts – Topline results of first triple expected in 3Q18

    Galapagos initiates the first triple combination trial (GLPG2451+GLPG2222+GLPG2737) of its cystic fibrosis portfolio. The aim of the FALCON study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of this triple combo in up to 24 patients.

    The open label trial will be composed of two parts:
    -The first part will evaluate a first dose of the dual combination GLPG2451+GLPG2222 with eight homozygous F508del patients during two weeks, followed by treatment with the triple combination for two weeks.
    -Part two will evaluate a higher dose of the dual combination for two weeks with eight homozygous F508del patients and eight heterozygous F508del patients with a minimal function mutation on the other allele. This will be followed by two weeks treatment of these two dose cohorts with the triple combination.

    Efficacy will be measured by changes in sweat chloride and percent predicted forced expiratory volume during the first second (ppFEV1%).

    Topline results from treatment in part one of the FALCON trial are expected in 3Q18.

    In the JAK inhibitor field, the Arthritis Advisory Committee yesterday discussed the efficacy and safety data of 2mg and 4mg doses of Eli Lilly’s baricitinib. The committee recommended approval of the 2mg dose for the treatment of moderately-to-severely active rheumatoid arthritis (RA) for adult patients who have had an inadequate response or intolerance to methotrexate. The committee did not recommend approval of the 4mg dose of baricitinib based on the safety and benefit-risk profiles.

    Our view
    The initiation of the FALCON trial has been long awaited. Galapagos faced significant delays as a result of an active metabolite with a half-life of about one month of one of the triple components (GLPG2451), which led to longer follow-up in healthy volunteers and delay of the regulatory process.

    In the meantime, Vertex has shown strong Phase II results with its triple combination and has initiated its first Phase III triple combination studies. As such, Galapagos has fallen behind in the cystic fibrosis race and is facing a high efficacy bar to reach.

    The news on baricitinib is a positive evolution for Galapagos in our view. Filgotinib has shown a cleaner safety profile to date (DARWIN 3) and will be able to present a more complete data set to the authorities going forward. While the 2mg baricitinib dose is likely to be approved and adopted, filgotinib has the potential to take significant market share given that the Phase III FINCH trials demonstrate comparable efficacy and confirm filgotinib’s safety profile. Importantly, limited concerns were raised on the severe adverse events observed with JAK inhibitors in general (infection rates, malignancies), a positive for the future of this class of therapeutics.

    Investment conclusion
    Galapagos has built a diversified portfolio of partnered and proprietary assets, of which filgotinib is nearing the readout of Phase III trials. The company is also putting strong focus on IPF, having taken significant strides towards a pivotal trial and potential approval. Considering the dense news flow, the broad pipeline and strong cash position, Galapagos remains one of our healthcare favourites for 2018.
  6. [verwijderd] 24 april 2018 14:31

    • [verwijderd]

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    quote:

    avantiavanti schreef op 24 april 2018 14:13:

    Leerink 24 april 2018

    Cool AdComm Reception Likely to Leave Market for ABBV/GILD JAKs; Key Data H2
    ... and we reiterate our view that each of the forthcoming JAK inhibitors will be
    judged on the merits of their respective phase III data sets. This may be
    advantageous for Gilead’s (GILD, MP) filgotinib if the drug avoids a phase
    III VTE imbalance due to its beneficial reduction of platelets, but could be
    detrimental to AbbVie’s (ABBV, MP) upadacitinib given the program’s VTE
    imbalance to date.
  9. NielsjeB 2 mei 2018 17:23

    • NielsjeB

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    Zie helaas niets over een new price target.

    Jefferies Group Equities Analysts Boost Earnings Estimates for Galápagos NV (GLPG)

    Galápagos NV (NASDAQ:GLPG) – Equities research analysts at Jefferies Group boosted their FY2022 earnings per share estimates for Galápagos in a research report issued to clients and investors on Tuesday, May 1st. Jefferies Group analyst P. Welford now expects that the biotechnology company will post earnings of $2.90 per share for the year, up from their prior forecast of $2.60.

    weekherald.com/2018/05/02/jefferies-g...
  12. avantiavanti 23 mei 2018 10:22

    • avantiavanti

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    Nomura/Instinet

    EULAR Abs: Clean Filgo P2b 108-Wk LTE Data Quick Note

    Galapagos and partner Gilead are slated to present a poster with data from their long-term extension P2b study (DARWIN 3) with filgotinib (oral JAK1 inhibitor) in moderate-to-severely active rheumatoid arthritis on June 16, 2018 during a poster session at EULAR. The abstract (#SAT0200; Long Term Safety of Filgotinib in the Treatment of Rheumatoid Arthritis: Week 108 Data from a Phase 2B Open-Label Extension Study) highlighted an impressive long-term safety profile further solidifying filgotinib as the cleanest JAK1 inhibitor (see Fig. 1). Efficacy was also robust and durable with 68% achieving ACR50 and 72% achieving Low Disease Activity (per DAS28-CRP<3.2) at week 108 in 491 patients. This follows the disappointing baricitinib RA ADCOM, where concerns around a dose-dependent increase in VTE (DVT and PE) events shut down any likelihood of a 4mg approval (we don’t expect a 2mg approval either, see note). A second baricitinib CRL is a positive for GLPG, in our view, and will focus attention on upadacitinib’s nearly comparable VTE rate. We find the EULAR abstract top-line findings from DARWIN 3 LTE safety study to be encouraging and reaffirm our thesis that filgotinib is the best-in-class JAK1 inhibitor.
    Bijlage:
  13. NielsjeB 23 mei 2018 12:06

    • NielsjeB

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    quote:

    avantiavanti schreef op 23 mei 2018 10:22:

    Nomura/Instinet

    EULAR Abs: Clean Filgo P2b 108-Wk LTE Data Quick Note

    Galapagos and partner Gilead are slated to present a poster with data from their long-term extension P2b study (DARWIN 3) with filgotinib (oral JAK1 inhibitor) in moderate-to-severely active rheumatoid arthritis on June 16, 2018 during a poster session at EULAR. The abstract (#SAT0200; Long Term Safety of Filgotinib in the Treatment of Rheumatoid Arthritis: Week 108 Data from a Phase 2B Open-Label Extension Study) highlighted an impressive long-term safety profile further solidifying filgotinib as the cleanest JAK1 inhibitor (see Fig. 1). Efficacy was also robust and durable with 68% achieving ACR50 and 72% achieving Low Disease Activity (per DAS28-CRP<3.2) at week 108 in 491 patients. This follows the disappointing baricitinib RA ADCOM, where concerns around a dose-dependent increase in VTE (DVT and PE) events shut down any likelihood of a 4mg approval (we don’t expect a 2mg approval either, see note). A second baricitinib CRL is a positive for GLPG, in our view, and will focus attention on upadacitinib’s nearly comparable VTE rate. We find the EULAR abstract top-line findings from DARWIN 3 LTE safety study to be encouraging and reaffirm our thesis that filgotinib is the best-in-class JAK1 inhibitor.
    Belangrijkste takeaway wat mij betreft:

    A second baricitinib CRL is [would be] a positive for GLPG, in our view, and will focus attention on upadacitinib’s nearly comparable VTE rate.

    [..] while ABBV’s upadacitinib may face scrutiny (or label-risks) if compiled data indicates dose-dependent increase in VTE.

    Hiermee zet de analist de deur voorzichtig op een kier voor afwijzing upa. Mocht dat werkelijkheid worden dan gaan we echt skyhigh met de koers. Maar zover is het nog lang niet, persoonlijk verwacht ik die 2e CRL niet voor bari. Op het vlak van de VTE volg ik de analist. Hoe meer long-term data er van filgotinib uitkomt en hoe meer AbbVie benadrukt dat de VTE-rate toch echt overeenkomt met de verwachte VTE-rate in RA patients, hoe minder ik ze geloof. Het is een van de twee: of filgotinib reduceert risico op VTE's of upa verhoogt het risico op VTE's.
  14. HansGarrincha 23 mei 2018 12:15

    • HansGarrincha

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    quote:

    NielsjeB schreef op 23 mei 2018 12:06:

    [...]
    Belangrijkste takeaway wat mij betreft:

    A second baricitinib CRL is [would be] a positive for GLPG, in our view, and will focus attention on upadacitinib’s nearly comparable VTE rate.

    [..] while ABBV’s upadacitinib may face scrutiny (or label-risks) if compiled data indicates dose-dependent increase in VTE.

    Hiermee zet de analist de deur voorzichtig op een kier voor afwijzing upa. Mocht dat werkelijkheid worden dan gaan we echt skyhigh met de koers. Maar zover is het nog lang niet, persoonlijk verwacht ik die 2e CRL niet voor bari. Op het vlak van de VTE volg ik de analist. Hoe meer long-term data er van filgotinib uitkomt en hoe meer AbbVie benadrukt dat de VTE-rate toch echt overeenkomt met de verwachte VTE-rate in RA patients, hoe minder ik ze geloof. Het is een van de twee: of filgotinib reduceert risico op VTE's of upa verhoogt het risico op VTE's.
    Ben het grondig met je eens: maar wat mij het meest verbaasd in deze note is:
    we[i] don’t expect a 2mg approval either[/i]
    Ik neem aan dat ze hier preluderen op een volgende CRL voor Baricitinib, en niet een volledige afkeuring. Beide assumpties natuurlijk wel positief uit te leggen voor Galapagos.
  15. NielsjeB 23 mei 2018 12:28

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    quote:

    HansGarrincha schreef op 23 mei 2018 12:15:

    [...]
    Ben het grondig met je eens: maar wat mij het meest verbaasd in deze note is:
    we[i] don’t expect a 2mg approval either[/i]
    Ik neem aan dat ze hier preluderen op een volgende CRL voor Baricitinib, en niet een volledige afkeuring. Beide assumpties natuurlijk wel positief uit te leggen voor Galapagos.
    Een rejection komt vrijwel nooit voor. CRL is meest gangbaar. Immers, wanneer er nieuwe data ingediend zou worden kan er wel een approval volgen.

    Vraag is echter hoever men nog wil gaan om bari goedgekeurd te krijgen als er opnieuw een CRL zou komen. Er zal dan opnieuw een studie gestart moeten worden om de FDA te overtuigen. Kans is aanwezig dat de nieuwe JAK's dan al op de markt zijn.
  17. avantiavanti 29 mei 2018 17:26

    • avantiavanti

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    Kempen 29 mei 2016

    Galapagos
    PSA preview: do you wanna know if this feeling flows
    both ways?

    Rating BUY
    Price Target €112.00
    Closing price (28 May 2018) €86.56
    Date 29 May 2018, 07:54

    While the big reveal with 3 phase III FINCH trials is scheduled for the
    second half of the year, the readout of the phase II EQUATOR trial in
    psoriatic arthritis (PSA) in the coming weeks could expand the range
    of filgotinib indications and have a positive read-through for RA trials.
    We believe the recently approved tofacitinib derisks the program and
    sets an attainable benchmark that could be exceeded both on safety
    and efficacy. PSA contributes €1/share to our valuation and we see
    €3/share upside if the program progresses to phase III.
    RA and PSA: a readthrough loop
    While PSA on its own can be a meaningful addition to filgotinib's peak
    sales (we estimate €500m in PSA), in our view, the near-term impact on
    the share price would be largely driven by the readthrough to the phase
    III RA trials. PSA and RA have a distinct pathogenesis, but the overlap
    in signaling cascades (e.g. TNF-a, IL-2, IL-18, IL-22, IFNy, Coates et al.,
    2016), which are all mediated or modulated by JAK, provides the rationale
    for the back and forth translation of activity between indications. While our
    optimism for the EQUATOR results is based on tofa's results in PSA and
    higher efficacy of filgotinib over tofa in phase II RA trials, higher ACR20 in
    PSA compared to tofa should further strengthen filgotinib positioning within
    the JAK class and add comfort to the phase III RA readouts, especially
    FINCH 1 and FINCH 3 trials (MTX IR and MTX-naive patients).
    EQUATOR trial should report any week
    The double-blind, placebo-controlled, phase II EQUATOR trial recruited
    131 patients with moderate to severe psoriatic arthritis who have
    inadequate control with cDMARDS, randomized 1:1 to filgotinib 200mg
    QD or placebo on top of concurrent cDMARDs. The primary endpoint is
    ACR20 on 16w (regulatory endpoint for approval), the secondary include
    both rheumatoid endpoints (ACR50/70, HAQ-DI) as well psoriasis (PASI).
    The trial was completed in Mar'18, and the data is expected any week now.
    Tofacitinib approval sets a low bar, looking for ACR20>17%
    Tofacitinib 5mg BID was recently approved in PSA despite not
    demonstrating superiority to Humira, and in our view sets a low bar of
    placebo adj. ACR20 of 17% to move ahead. Looking at the biologics in
    PSA, (see Figure 1 below), the placebo adj. ACR20 of >25% combined with
    clean safety and the convenience of oral administration should demand a
    meaningful market share and position filgotinib ahead of biologics.
    Safety: comforting statements
    Considering a relatively small number of patients and a short duration
    of the trial, we don’t expect comprehensive evidence on thromboembolic
    events (tofa 5mg had 0/342, (Mease et al., 2017), background rate in PSA
    is 0.32-0.38), but we expect lower rates of severe infections and herpes
    zoster with filgotinib (tofa was 1%/1% at 3 months or 1.57/1.96 100PY) as
    well as a beneficial impact on lipids levels as suggested by RA trials.
  20. avantiavanti 31 mei 2018 09:53

    • avantiavanti

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    Kempen 31 mei 2018

    Unprecedented PSA data supports competitive profile in RA

    Galapagos reported unprecedented efficacy with filgotinib in psoriatic arthritis (PSA) and confirmed its clean safety profile which should demand the leading role in the treatment paradigm ahead of biologics. The results also surpassed efficacy of tofacitinib in PSA by a wide margin, thus in our view, supporting filgotinib's competitive profile in RA and giving comfort for FINCH 1/2/3 readouts. Filgotinib also moved to the phase III trial in UC, and while futility criteria were said not to be challenging, a difference in endoscopic response would suggest an objective benefit in this indication. We move PSA to phase III and add €3 to our PT bringing it to €115 ($135 for ADR).
    Bijlage:
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