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Home  /   Forum   /   Galapagos   /   Analyst reports 2020

Aandeel Galapagos AEX:GLPG.NL, BE0003818359

Laatste koers (eur) Verschil Volume
24,960   +0,260   (+1,05%) Dagrange 24,700 - 0,000 33.984   Gem. (3M) 107,1K

Analyst reports 2020

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308 Posts
Pagina: «« 1 ... 4 5 6 7 8 ... 16 »» | Laatste | Omlaag ↓
  1. avantiavanti 24 april 2020 10:37
    Kempen extract uit update 24 april 2020
    Buy
    PT 230 euro

    Galapagos - Expectations ahead of SELECTION
    We expect Gilead/Galapagos to report topline results from the phase III SELECTION trial with filgotinib in ulcerative colitis later in Q2'20. For a competitive profile, we will look for clinical remission rates of c. 15% at week 10 (induction) and c. 25% at week 58 (maintenance), in addition to a clean safety profile. Although the shares have recovered from the low in March, cash still contributes close to 50% of the market cap and we believe there is still a 5-10% upside in the SELECTION read-out, particularly if it confirms filgotinib's best-in-class profile. Going into the readout we reiterate our BUY rating and €230 PT.
  3. forum rang 4 Wall Street Trader 28 april 2020 16:27
    Antwoord op schriftelijke vragen

    Galapagos ontving op 24 april 2020 schriftelijke vragen van de Vereniging van Effectenbezitters met verwijzing naar de algemene vergaderingen van 28 april 2020.

    VEB vragen AV Galapagos 2020

    www.glpg.com/docs/view/5ea7ffabe79e1-nl

    Schriftelijke antwoorden

    www.glpg.com/docs/view/5ea7ffef6423f-nl

  4. avantiavanti 8 mei 2020 08:26
    Jefferies

    1Q Immaterial; Focus on Upcoming Filgotinib UC Phase III and RA Approvals
    Peter Welford, CFA *, Philippa Gardner, Eng.D. *, Lucy Codrington *, Colin White, PhD *

    Date May 7, 2020

    Key Takeaway
    1Q financials are largely immaterial for the shares, with lower Revenues and OpEx vs cons for a broadly similar underlying loss. Cash burn outlook trimmed €20m to €400-430m on COVID-19 trial delays vs JEFe €441m. We are optimistic upcoming filgotinib Phase III SELECTION data in ulcerative colitis will be positive and on arthritis approvals 2H20E. Initial Toledo '3312 is deprioritised over more selective '3970 with Phase IIa starts 2H for first efficacy 1H21E.

    RATING
    BUY
    PT €210.00

    Insights
    Optimistic on upcoming SELECTION data:     Phase III SELECTION data evaluating JAK-1 inhibitor filgotinib in ulcerative colitis (UC) are on-track for 2Q20E. We previously outlined that placebo-adjusted remission of 10%-15% at Week-10 induction and 20%-25% at Week-58 would be competitive. Notably, on our recent KOL call, expert was very enthusiastic on JAK inhibitors as an oral option for inflammatory bowel disease, particularly Crohn's, but felt it would perhaps be challenging for filgotinib to differentiate on safety vs JAK1-3 Xeljanz.

    We forecast $6bn WW peak sales for filgotinib, with $3bn in RA, $600m in Crohn's disease, $400m in UC, and a $2bn cumulative contribution for other indications, combined worth c.€94/share (c.45% of NPVs) at 95% probability.

    [b]RA approval still expected 3Q20E, but uncertain delays to ongoing filgotinib trials:[/b] GLPG and partner Gilead still anticipate FDA, EU and Japanese approvals for rheumatoid arthritis (RA) during 2H20E. All Gilead filgotinib manufacturing sites are in good standing with FDA and are GMP certified, so inspections should not lead to delays. In light of the COVID-19 pandemic, recruitment into other filgotinib trials has been paused, likely leading to delays to Phase III Crohn's disease data (was mid-2021E) and Phase III psoriatic arthritis data (was 1H22E), among others; the Phase III ankylosing spondylitis trial is now expected to initiate 2H20E.

    Funds to rapidly advance pipeline: Ziritaxestat (GLPG1690) is in the Phase III ISABELA trial in lung fibrosis (IPF) with >1,000 of target 1,500 patients now enrolled but recruitment slowing due to COVID-19. The interim analysis is anticipated 1H21E and final data 1H22E. The Phase II in systemic sclerosis is due to readout 3Q20E. Ziritaxestat contributes c.€16/share NPV based on 40% probability of $1.85bn WW peak sales in IPF. We expect a significant proportion of the c.$5bn from Gilead to be used to accelerate GLPG's secretive Toledo programme in order to maximise first-mover advantage with this undisclosed mechanism of action. Development of second-gen compound '3970 (TOL2/3) is now being prioritised given a "superior profile", due to start an extensive Phase IIa proof-of-concept programme across multiple inflammatory indications during 2H20E for data 1H21E. We assume $3bn peak sales for the broad programme at 15% probability for a c.€4/share NPV. GLPG1205 Phase IIa PINTA data also in IPF are expected during 2H20E. Data from the Phase IIb ROCELLA trial of GLPG1972 in osteoarthritis are expected 4Q20E triggering a 60-day opt-in period for Gilead for US rights; we forecast $3bn WW peak sales, for a c.€6/share NPV at 20% probability; Servier has ex-US rights.
  5. avantiavanti 8 mei 2020 08:31
    Barclays 7 mei 2020

    Galapagos 1Q20 first take: 2020 is on track

    Stock Rating/Industry View: Overweight/Positive
    Price Target: EUR 225.00

    All 2020 readouts are very importantly confirmed; wider timing window now on ISABELA next year in light of COVID-19 and prioritization of Toledo assets to be focus of tomorrow’s call

    Pushing forward towards commercialization

    Galapagos reported 1Q20 results this evening with most financial metrics in the same ballpark as our forecasts; the most important financial takeaway from the release is that operational cash burn for 2020 is now expected to be in the range of €400-430mm vs. the prior expectation of €420-450. The downward revision is primarily due to the temporary pause in recruitment for some ongoing phase 2 and 3 trials as a result of the COVID-19 pandemic (see: Galapagos: Pause to new filgotinib trial enrollment but SELECTION readout still on for 2Q (23/03/20)).

    We expect investors will mostly be focused on the regulatory and pipeline updates contained in the release:

    · Regulatory decisions for filgotinib in RA continue to be anticipated later in 2020 (this was affirmed by GILD last week; see: European Mid Cap Pharmaceuticals: Up late for West Coast biotech updates (readthroughs to GLPG, GMAB and UCB) (01/05/20))

    · SELECTION data for filgotinib in ulcerative colitis continues to be expected in 2Q20

    · The ROCELLA phase 2b trial of GLPG1972 in osteoarthritis continues to be expected in 2H20

    · The futility analysis of the phase 3 ISABELA trials of GLPG1690 in IPF is now expected in 1H21 vs. prior 1Q21: While we see an impact on recruitment rates due to COVID-19, mitigations such as virtual visits and direct shipment of medication to patients keep the trial running relatively smoothly for the more than 1,000 patients randomized to date

    · Top-line results of the NOVESA phase 2a trial of GLPG1690 in systemic sclerosis continues to be expected in 2H20

    · Recruitment in the PINTA phase 2 IPF trial of GLPG1205 was completed in early 2020 and top-line results are expected later this year

    · Toledo: phase 1 studies were completed in healthy volunteers with GLPG3312 and GLPG3970. Given the superior profile of GLPG3970, this asset will be prioritized. The start of several POC trials with GLPG3970 is expected in 2H20, with top-line results expected in 1H21

    We spoke to the company this evening, which indicated that whilst it very much hopes that the ISABELA readout will be in 1Q21, given the COVID-19 driven slowdown seen at some sites, Galapagos wanted to build in a bit more time into its guidance. Encouragingly, sites in Asia are picking back up again as the region recovers from its initial outbreak. Regarding the Toledo news, the profile seen from the phase 1 data in ‘3970 was just “all around better” than '3312 and this it makes sense to take the former forward and discontinue the latter.

    In our view, this is the kind of update where, if one wants to focus on something negative, one could certainly do so by being concerned regarding the ISABELA potential delay and the discontinuation of ‘3312, following the company’s prior enthusiasm regarding the asset. But we think that would be missing the forest for the trees. All aspects of what make 2020 a transformative year for the company continue to be in place, and a very significant readout is just around the corner in the SELECTION readout for filgotinib in UC, in our view. We look forward to learning more about how the company is thinking about becoming commercial as well as more details on the pipeline announcements on tomorrow’s call.

    Galapagos will be hosting its 1Q20 conference call tomorrow (08/05/20) at 1:00pm BST / 8:00am EST; UK dial-in +44 330 336 9105 / US dial-in +1-323-794-2423; passcode 6118715.
  6. avantiavanti 8 mei 2020 09:56
    RBC

    Toledo Setback in Line with Our Cautious View of the Program; First Data Now Expected 1H21

    First Glance | Comment
    May 7, 2020

    RBC Capital Markets, LLC
    Brian Abrahams (Analyst) (212) 858-7066
    Gilbert Kinsey (Senior Associate)

    Sector: Biotechnology
    Rating: Sector Perform
    Impact: Negative

    This evening, GLPG noted that it will deprioritize lead Toledo agent GLPG3312 and instead work with ’3970 for proof of concept, pushing patient data to 1H21. While these compounds are early-stage and the opportunity for filgotinib and strong cash floor help to support shares, given GLPG’s valuation we believe the Street is also baking in meaningful credit for pipeline programs like Toledo, around which the company has expressed significant enthusiasm. Though it has a promising profile (inhibiting pro-inflammatory responses and boosting anti-inflammatory cytokines), our diligence had led to our caution around the program and view that the market was over-emphasizing its potential upside; we believe the Toledo program should be viewed as more akin to its prior CF program, with multiple potential candidates to be evaluated and optimized over time. We continue to believe that at current levels, the positive attributes of GLPG’s significant balance sheet and broad pipeline are fairly balanced by the risk inherent to early-stage drug development exemplified by today’s announcement of the setback to the Toledo program.

    Lead Toledo compound ’3312 deprioritized. After the close, GLPG released its 1Q20 earnings, and though we await more details on its call tomorrow, we note the deprioritization of GLPG3312, its first-generation Toledo compound, mentioned in the press release. Recall that the target for this program has not been disclosed, though our diligence suggests the compounds inhibit the salt-inducible kinase family. While it is disappointing that ’3312 will not continue in clinical studies, GLPG noted its plan to initiate several PoC clinical studies with second-generation, more selective Toledo compound ’3970 in 2H20, with first top-line results from Toledo now expected in 1H21.

    Early signals suggested to us that ’3312 may have some liabilities, and we are not surprised to see GLPG move on to different compounds in the program. Even before we uncovered the potential target of the Toledo program, we learned from our discussions with management that ’3312 was being developed as a locally acting agent in the gut, suggesting potential tolerability issues with systemic absorption. We also noted the continued pushout of ph.I data release from the program (initially expected in 2019), and management’s greater focus on its multiple backup compounds in the program when queried about the progress with ’3312. Finally, when comparing recent patents describing what we believe are the first- and second-generation Toledo compounds, we noted that the treatment was limited to lower doses in animal models.

  7. forum rang 4 Wall Street Trader 8 mei 2020 09:59
    Bryan Garnier & Co Galapagos (Buy) PT EUR 230

    An eventful year 2020 for Galapagos

    Cash burn guidance reduced in light of Covid-induced delays

    Yesterday evening, Galapagos reported its Q1 2020 figures marked by the impact of
    Covid-19 on the recruitment rate and trial starts. This led the company to revise down
    its cash burn guidance from EUR420m-450m to a range of EUR400-430m. Overall,
    Galapagos’ financial fundamentals are strong with a cash position amounting to
    EUR5.7bn at the end of March 2020 allowing the company to continue to grow the
    pipeline and deliver on the anticipated commercial launch of filgotinib in RA (PDUFA
    date : August 2020).

    Next catalyst: data from phase III SELECTION in UC

    We are optimistic about the forthcoming phase III SELECTION data, which should be
    presented in coming weeks. As a reminder, the phase IIb/III SELECTION study was
    initiated back in December 2016, evaluating filgotinib’s potential in 1,300 patients
    with moderate-to-severe ulcerative colitis. Co-primary endpoints are clinical
    remission at respectively week-10 and week-58 for the induction and maintenance
    periods. Overall, we are expecting filgo to be on par with Xeljanz’s efficacy (a JAK1-
    3 inhibitor) but with a superior safety profile. In comparison, Xeljanz reported a
    placebo-adjusted induction of clinical remission at week-8 in 10-13% of patients, and
    a pbo-adj maintenance of clinical remission at week-52 in 23% of the patients. We
    forecast USD6.5bn WW peak sales for filgo, including USD755m in UC.

    GLPG1972 ph II results could trigger Gilead opt-in decision

    The company expects to report top-line results from the ROCELLA phase IIb trial of
    ‘1972 in osteoarthritis in H2. Initiated back in June 2018, this trial has been fully
    recruited since June 2019, thus spared from the ongoing pandemic situation.
    Following completion of this study, Gilead could exercise a USD250m option to get US
    rights, plus up to an additional USD200m on achievement of certain endpoints and up
    to USD550m in potential milestones. We forecast USD4bn WW peak sales.

    ISABELA’ recruitment impacted, rest of IPF portfolio well on track

    Within the fibrosis portfolio, the company expects to report top-line results from
    PINTA ph II trial with ‘1205 in IPF and NOVESA ph IIa data of ‘1690 in SSc. Regarding
    ‘1690, Galapagos has already seen an impact on recruitment rates of the ISABELA
    phase III programme, for which the outcome of the futility analysis is anticipated for
    the first half of 2021 and top-line data for 2022.

    Toledo: ‘3970 prioritized over ‘3312

    Initially, the company was expecting to start a phase II with the 1st generation Toledo
    compound ‘3312 in ulcerative colitis during 2020. They have now decided to prioritize
    ‘3970 due to a superior profile, probably driven by a better safety profile given that
    ‘3312 suffered from undisclosed toxicity that prevented an oral delivery.
    Proof-ofconcept trials with ‘3970 should start in H2 with top-line results expected in H1 2021.

  13. forum rang 4 Wall Street Trader 15 mei 2020 11:01
    Analysts Stock Target Prices As of 15 May 2020

    Bank of America Merrill Lynch Underperform € 195

    Barclays Capital Buy € 235

    Bernstein Hold € 180

    Berenberg Buy € 225

    Bryan, Garnier & Co Buy € 230

    Cantor Fitzgerald Hold € 177

    CITI Hold € 190

    Cowen & Co. Buy NA

    Credit Suisse Hold € 220

    Degroof Petercam Hold € 220

    Goldman Sachs Hold € 108

    H.C. Wainwright & Co. Buy € 279

    Jefferies Buy € 210

    J.P. Morgan Neutral € 185

    KBC Securities Hold € 189

    Kempen & Co. Buy € 230

    Leerink Buy € 217

    Morgan Stanley Hold € 208

    Nomura Instinet Buy € 267

    Raymond James Market perform NA

    RBC Capital Markets Sector Perform € 144

    Stifel Buy € 275

    UBS Neutral € 194

  17. avantiavanti 21 mei 2020 08:58
    Instinet quick note 20 mei 2020

    First Look: SELCTION UC Results Positive, more discussion on our investors call with CMO on May 21 10am

    GLPG/GILD announced top-line data from the Ph3 SELECTION filgotinib trial (NCT02914522) in patients with moderately to severely active ulcerative colitis (UC); PR here. The study met the primary endpoint for 200mg filgotinib arm, and results were robust regardless of prior biologic use. Recall, we previewed these results in our note here. We view the results, as presented, positively and in line with expectations and other agents (Fig 1) as we await further details at a scientific meeting. We anticipate additional data will provide details on the patient populations enrolled and safety that may augment a more detailed comparison to potential competitors. Reiterate Buy.

    We will host an investor call Thursday May 21, at 10am ET with GLPG CMO, Dr. Walid Abi-Saab, to discuss the results – contact sales or analyst for dial-in and submit any questions you may have to analyst prior to call.

    High Doses Required for Remission Induction as Anticipated – Filgotinib at 200mg met the primary endpoint in the study, demonstrating statistically significant higher rates of clinical remission at week 10 and maintaining clinical remission at week 58 vs. placebo. The low dose (100mg of filgotinib) did not meet the primary endpoint in clinical remission but did show a statistically significant difference vs. placebo in maintaining clinical remission at week 58. This result is not surprising, higher doses of JAKi have been required for efficacy in IBD. Low dose activity in maintaining remission was encouraging and suggests a potential for dose reduction to increase the already strong benefit/risk profile in some patients.

    Safety Remains Strong, but Details Sparse – Similar to other trials of filgotinib, the drug was well tolerated, though safety events weren’t fully broken out (we expect that at a medical meeting), including rates of serious infections, herpes zoster, venous thrombosis, pulmonary embolism and gastrointestinal perforation that were low and comparable across groups in both phases of the study; two deaths occurred but appear to be unrelated to the study drug. We anticipate further interest in venous thrombosis (DVT) and pulmonary embolism (PE) event rates (not disclosed), even if very rare, given the relevance to the JAK MOA and lower rate of these AEs observed to date for filgo that confers a relative safety advantage vs. others.
  18. avantiavanti 21 mei 2020 09:02
    Morgan Stanley

    Filgotinib Solid on High Dose in UC; Low Dose Mixed

    Matthew Harrison, Connor Meehan
    May 21, 2020

    Filgotinib demonstrates durable efficacy at the 200mg dose in Ulcerative Colitis (UC): The PhIIb/III SELECTION trial of filgotinib in patients with moderate to severe UC included 1,348 patients randomized either to the 100mg or 200mg dose level, in both biologic naïve patients (n=659), and patients who have previously been treated with a biologic (n=689). At Week 10 (200mg), 26.1% of biologic naïve patients achieved remission vs. placebo (15.3%, p=0.0157), as measured by Mayo Score. At the 200mg dose level, in the biologic experienced cohort, 11.5% of patients achieved remission vs. placebo (4.2%, p=0.0103). Patients treated with the 100mg dose did not achieve a statistically significant result at Week 10. Patients that achieved clinical response or remission (at both dose levels) were treated to Week 58. Both dose levels achieved statistically significant results in this maintenance trial. At Week 58, at the 200mg dose level, 37.2% of biologic naïve and experienced patients achieved clinical remission, vs. placebo (11.2%, p<0.0001), and at the 100mg dose level, 23.8% of patients experienced clinical remission, vs. placebo (13.5%, p=0.042).

    In the biologic naïve population, data appears relatively consistent with competitive JAK inhibitors: In the induction trial, at the 200mg dose level, filgotinib's efficacy appears roughly consistent with data from competitive JAKs that have been evaluated under similar circumstances (in UC, as measured by Mayo Score, percent of patients achieving remission). A full comparison to tofacitinib (Xeljanz, Pfizer), upadacitinib (Rinvoq, Abbvie), and peficitinib (Astellas/J&J) can be found below. Xeljanz efficacy appears similar in both biologic naïve and experienced patients, but given the limited breakout, we believe it is hard to make a definitive statement on how filgotinib compares in these sub-populations. On safety, the rate of serious adverse events was similar across dose levels in both the biologic naïve (200mg: 1.2%, 100mg 4.7%, Placebo: 2.9%), and in the biologic experienced cohorts (200mg: 7.3%, 100mg 5.3%, Placebo: 6.3%). However, without detailed data, it is hard to compare on relevant factors like DVT/PE and infections. While there were two deaths reported in the filgotinib arms, we do not foresee major issues given the factors described in the press release.

    Failure of low dose in induction likely to spark some investor debate: Given the pending data from MANTA, we would expect some investors to be concerned about the sole success of the higher dose. That said, given that you would only need to give 200mg as induction and then could switch to 100mg for maintenance, we do not see the data as a significant long-term commercial issue. Overall, we would expect some pressure on GLPG/GILD given investors had high expectations for the data.

    PDF: Competitive JAKi Data: Ulcerative Colitis
    Bijlage:
  19. avantiavanti 21 mei 2020 09:28
    Bersnstein 21 mei 2020

    Galapagos/Gilead: Filgo UC data in-line; Commercial reality will remain the challenge

    Galapagos/Gilead just released headline data for filgotinib in Ulcerative Colitis. We provide a few thoughts here.

    Headline efficacy in-line with expectations (when pbo adj.). GLPG management commented on UC efficacy expectations at 1Q and the results seem in-line. In short, filgo 200mg looks a little better vs. Xeljanz but differences are not particularly large (when pbo adjusted). Until we have Rinvoq p3 data (2021), it will be hard to suggest filgo is the best in class JAK in UC but compared to existing options, it clearly offers a strong alternative. Again, we caveat cross trial comparisons here given different baseline characteristics and differing endpoints (arguably more stringent here removing physician assessment and including only EBS - endoscopic, rectal bleeding, stool).

    A Xeljanz like dosing regimen? We expect filgo to be approved at both 100/200mg doses for RA but the lack of stat. sig. efficacy in the 100mg induction phase suggests it may be more challenging in UC. Could we have an approval for a 200mg induction followed by 100mg for maintenance (a bit like Xeljanz) - potentially but we see no reason given the safety…

    Safety looks to support best in class profile. We will need to see the details but headlines further support filgo's relatively clean safety profile with infections, herpes zoster, venous thrombosis, pulmonary embolism and GI perforation low and comparable across treatment groups in both phases of the study. These are the ones we care about.

    Investment implications
    The UC data for filgo is encouraging but does little to change our expectations in the indication ($0.6B which we currently include at 90%). More importantly, updates elsewhere (Xeljanz tough pricing, Rinvoq strength) re-emphasises our concerns on the commercial realities of the market – it is going to be competitive and clinical data alone may not be enough.
  20. forum rang 4 Wall Street Trader 21 mei 2020 10:15
    Bryan Garnier & Co Galapagos (Buy) PT EUR 230

    Positive results in UC, but additional data needed to get a clearer view

    Stronger results than the market reaction would suggest

    Just in time before the end of Q2 2020, Galapagos and Gilead have announced topline results from the phase IIb/III SELECTION trial evaluating two doses (100mg & 200mg) of the JAK1 inhibitor filgotinib in 1,348 biologic-naïve and -experienced
    adult patients with moderately to severely active ulcerative colitis. As a reminder,
    the study co-primary endpoints were clinical remission at week-10 and week-58, for
    the induction and maintenance periods. While both doses of filgo achieved the
    primary endpoint in the maintenance trial, only Filgo 200mg met statistically
    significant clinical remission at Week 10. Although we acknowledge that those
    results are less clear than expected, we believe that the market is overly pessimistic
    by sending the stock down over 10% in after-hours trading.

    Efficacy is in line with other JAK inhibitors

    Before going into results’ details and cross-trials comparison, it is worth bearing in
    mind that it is challenging to compare clinical trials for biologic therapies in
    ulcerative colitis, especially given that those studies use different degree of
    biologic-exposure, times of follow-up and endpoints. Past the caveats that patients
    from the study seem to be more refractory (50% previously treated with two
    different classes of biologics) than other UC studies, and that clinical remission is
    here based on EBS and not Mayo score, we believe those results compare well to
    others JAK inhibitors such as Xeljanz both for induction and maintenance phases.

    Differentiated safety profile

    While we were expecting that efficacy would be comparable to competitors, we
    anticipated that filgotinib could further differentiate itself with a strong safety
    profile, especially in the context of the concerns related to the JAK inhibitor class
    overall. As a reminder, in 2019 FDA issued new warnings about increased risk of
    blood clots and death with the 10mg twice-daily dose of Xeljanz, limiting the use of
    this dosage. Even though we are waiting for the full results to be disclosed in the
    coming months, safety profile of filgotinib seems to meet expectations with a very
    clean profile. Incidence of serious adverse events and serious infections was similar
    across treatments for the two doses in both the induction and the maintenance
    parts. We believe those data confirm once again filgotinib’s differentiated safety
    profile driven by its JAK1 selectivity.

    We reiterate our FV while waiting for additional data

    Overall, we believe that those results are promising, especially in terms of safety
    profile and efficacy in the maintenance setting. Now, more data is needed for each
    of the sub-populations and in particular across the different lines of treatment, but
    also to have other endpoints like the increasingly strategic one of endoscopic
    healing improvement to better assess the kind of market share filgo is able to take
    in UC. Upcoming etrolizumab phase III results will also be very helpful to compare
    strategies. We will update our model once we have more of this in our hands.

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