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Analyst reports 2019

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avantiavanti
3
Barclays 29 maart

Galapagos

FINCH results – looking like birds of prey in the JAK class

Stock Rating/Industry View: Overweight/Positive
Price Target: EUR 130.00
Price (28-Mar-2019): EUR 85.06
Potential Upside/Downside: 53%
Tickers: GLPG NA / GLPG.AS

The data is finally here…and it’s looking good to us

This evening, Galapagos and partner Gilead (covered by Geoff Meacham) released the results of the eagerly anticipated FINCH 1 & 3 trials of filgotinib in rheumatoid arthritis (RA). This is the 2nd and 3rd phase 3 readouts in RA, following the FINCH 2 data, which was top-lined on 11th September 2018 (FINCH takes flight in rheumatoid arthritis (11/09/18)). FINCH 1 (which was testing filgotinib 100mg & 200mg on top of a methotrexate (MTX) backbone vs. Humira + MTX and vs. placebo + MTX in patients who had prior inadequate responses to MTX) and FINCH 3 (which was testing filgotinib 100mg & 200mg + MTX vs. filgotinib 200mg monotherapy vs. MTX monotherapy in MTX naïve patients) both met their primary endpoints of achieving an American College of Rheumatology 20% response (ACR20) (in FINCH 1 vs. placebo at week 12 and in FINCH 3 at week 24).

We’d note that the metric investors had been most keenly watching for was rates of thromboembolic events (see: Galapagos: One day more...? (28/03/19)). FINCH 1 saw one venous thrombotic event (VTE) across the filgotinib groups and two in the placebo group, whereas FINCH 3 saw no venous thrombotic events in the filgotinib groups and one event in the MTX group. To us this is seemingly as good of a safety scenario as we’d expected for filgotinib; just one event of VTE across a total of 1,788 patients treated with filgotinib in the two trials.

The companies also filed a safety update based on the pooled interim data from the three phase 3 FINCH trials and the updated week 156 safety data from the phase 2b DARWIN 3 long term extension safety study. Of 2,088 patients treated with filgotinib, there’s been only 1 case of deep vein thrombosis/pulmonary embolism, which equates to a rate of <0.1%. GLPG’s CEO commented in an email to analysts: “Importantly, the favorable safety data observed across broad RA populations in FINCH 1,2 &3 and the long term DARWIN 3 trial strongly support the hypothesis that our JAK1 selectivity is advantageous. The data also support the submission of 2 doses of filgotinib for approval. With filgotinib treatment, there are improvements of hemoglobin, reduction of platelets, and improvement of lipid profile observed. In the FINCH safety data there is no dose-dependent difference on safety parameters, or, better said, there are no safety flags.” (emphasis ours).

We’d characterize efficacy as generally looking good as well. In FINCH 1, across the endpoints of ACR20, ACR50, ACR70, % of patients with low disease activity (DAS28(CRP=3.2)) and % patients achieving clinical remission (DAS28(CRP<2.6)), both filgotinib arms had p values <0.001 vs. the placebo arm. The filgotinib 200mg arm was superior to Humira on the clinical remission endpoint and the 100mg arm was non-inferior to Humira.

In FINCH 3, both filgotinib arms on top of MTX met stat. significance for the ACR20, ACR50, ACR70 and clinical remission endpoints vs. MTX monotherapy. We would note that the filgotinib 200mg monotherapy arm did not appear to meet statistical significance vs. MTX on the ACR20 endpoint, but it did on the ACR50, ACR70 and clinical remission endpoints. The only other efficacy endpoint we will look for further clarification on is why the change in the modified total Sharp score (mTSS, which measures the progression of structural damage), met statistical significant for both the filgotinib arms in FINCH 1, as well as for the filgotinib 200mg monotherapy arm in FINCH 3, but not the filgotinib + MTX arms in FINCH 3. All treatment arms across both studies met statistical significance on the Health Assessment Questionnaire Disability Index (HAQ-DI) endpoint.

When comparing tonight’s data vs. the relevant trials of Abbvie’s (covered by Geoff Meacham) upadacitinib, we’d generally say the efficacy/safety of filgotinib looks to be at least on-par with/if not a bit better. In FINCH 1, the 200mg filgotinib arm looks a touch better vs. the 15mg upadacitinib arm across efficacy endpoints. In FINCH 3, both arms of filgotinib on top of MTX look marginally better across efficacy endpoints, with the 200mg monotherapy arm looking more comparable on the endpoints where it did meet statistical significance (we would note the MTX monotherapy arm had 71.4% of patients achieving ACR20 in FINCH 3, vs. 54.1% in SELECT-EARLY). From a safety perspective, we’d highlight lower rates of both serious infections and herpes zoster in the filgotinib treatment arms vs. the upadacitinib treatment arms.

Gilead, who will be leading the regulatory process for filgotinib, has previously indicated that once it had presented the FINCH 1 & 3 data, it intended to meet with the FDA in order to determine next steps towards an NDA filing (particularly in light of what information the company may need from the ongoing MANTA safety study in order to support filing). We look to get an update from Gilead on timing in the coming weeks.

Filgotinib in RA is €43.58/share (30%) of our total €132.94/share NPV for Galapagos. This is based on our current peak sales estimates of €2.8bn, €1.7bn of which is in RA. We also model for filgotinib contribution from ulcerative colitis (€13.45/share; 9%) and from Crohn’s disease (€12.27/share; 9%). In light of tonight’s readout, our estimates are currently under review, but in light of this positive development, we do expect a positive reaction from GLPG shares tomorrow.
avantiavanti
3
Degroof Petercam 29 maart 2019

Galapagos (Buy) - FINCH-1 and 3 reach primary endpoint, best-in-class safety profile confirmed (EUR 85 / TP EUR 136 from 125)

Facts

FINCH-1:
Evaluated filgotinib versus adalimumab or placebo in RA patients with prior inadequate response to methotrexate, on a stable background of methotrexate.
Achieved primary endpoint (ACR20) at week 12 for both doses of filgotinib.
Proportion of patients achieving ACR50 and ACR70 response was also significantly greater for both doses of filgotinib compared with placebo at week 12.
At week 12, filgotinib 200mg + MTX demonstrated non-inferiority to adalimumab when comparing low disease activity rates (DAS 28(CRP) = 3.2).

FINCH-3:
Evaluated filgotinib in combination with methotrexate and as a monotherapy in MTX-naïve patients.
Achieved primary endpoint (ACR20) at week 24 for both doses of filgotinib. Monotherapy with 200 mg filgotinib did not demonstrate a significant difference in ACR20 response vs MTX (but nominal superiority on ACR50/70 was shown).
Both doses of filgotinib also scored significantly better on ACR50/70 than MTX alone at week 24.

Overall safety profile:
No dose-dependent impact on safety noted.
Data from the 3,425 patients (of which 2,088 treated with filgotinib) shows a best-in-class safety profile. The overall rate of serious adverse events remained low in comparison to adalimumab and placebo. Importantly, only one DVT/PE was reported in the total FINCH population (up to week 24).
Lab parameters also remained favorable, with improvements in hemoglobin, reduction of platelets and improvement of the lipid profile (data to be disclosed at upcoming conferences).
The companies further report updated safety results from the DARWIN3 long term extension study (up to week 156, 2,203 PYE), demonstrating a continued strong safety profile with a DVT/PE rate below 0.1.

Our view

Filgotinib showed strong efficacy results that continue to be competitive in the JAKi space, specifically when evaluating the highest dose (200 mg). All primary endpoints were achieved, while the more clinically relevant ACR50/70 scores showed strong improvements versus placebo and adalimumab.
We do note higher than expected adalimumab and methotrexate ACR responses, which somewhat clouds the strong response to filgotinib. Looking at disease activity parameters and remission scores, the performance of filgotinib is more outspoken, demonstrating non-inferiority to adalimumab on low disease activity as well superiority on clinical remission.
The focus for this set of results is for a large part on the safety profile, as this is turning out to be the main differentiator of filgotinib within the JAK class. We note the lack of a dose-dependent impact on safety parameters and the low rate of DVT/PE. While other JAKi have generally needed to focus on one dose, filgotinib may keep the flexibility of providing two doses.

Investment conclusion

Galapagos and Gilead reported strong results for filgotinib across patient populations and different doses. The company expects to file for market approval in Europe and Japan in 2019. Gilead indicated previously they would already approach the FDA with these FINCH data, starting discussions on the risk/benefit profile, while awaiting the outcome of the MANTA study. The good safety profile should give the company a strong competitive edge versus other JAKi. We estimate peak sales for filgotinib in RA up to EUR 3.8bn. We raise our TP to EUR 136 at this point and reiterate our Buy recommendation.
avantiavanti
3
Kempen 29 maart 2019

Rating BUY
Price Target €135.00

Two FINCHes with one filgo
Bijlage:
avantiavanti
5
1 van de betere rapporten so far

Wainwright & Co 29 maart 2019

May the Force Be With Filgotinib; Raising Target to $150
(from 136$ initiated gisteren)
Bijlage:
Kompas
0
quote:

avantiavanti schreef op 29 maart 2019 12:30:

H.C. Wainwright & Co 29 maart 2019

[b]May the Force Be With Filgotinib; Raising Target to $150 [/b]
(from 136$ initiated gisteren)

Wat een geweldige titel van dit rapport !! hahahaha
Wall Street Trader
2
Analyst Price Targets

Cantor Fitzgerald 28 maart 2019 Price Target $150

SVBLeerink 28 maart 2019 OUTPERFORM

RBC 28 maart 2019 Sector Perform

Berenberg 29 maart 2019 Price Target € 112

Barclays Capital 29 maart 2019 Price Target € 130

Degroof Petercam 29 maart 2019 Price Target € 136

Kempen 29 Maart 2019 Price Target € 135.00

H.C. Wainwright & Co. 29 Maart 2019 Price Target $150

KBC 29 Maart 2019 Price Target € 124

Credit Suisse 29 Maart 2019 Price Target € 113

Jefferies & Co. 29 Maart 2019 Price Target € 120
avantiavanti
4
Stifel 29 maart 2019

PT van $111,- naar $121,-

Positive Top-Line P3 Filgotinib Results in FINCH 1 & 3 RA
Studies; Excellent Safety Profile Differentiated vs. Competition
Bijlage:
avantiavanti
7
SVB Leerink 2 april 2019

GALAPAGOS NV
Bouncing and Gliding Higher, FINCH-like: Increasing PT to $150,
Reiterate OP

Bottom Line: We are maintaining our Outperform rating on GLPG and
increasing our 12-month price target to $150 per share from $140 per
share following the announcement of positive results from the Phase
3 FINCH1 and FINCH3 trials for filgotinib to treat rheumatoid arthritis
(RA). Our price target increase is a result of increasing the probability of
success (PoS) for filgotinib to treat RA from 68% to 90%. We anticipate
further catalysts in 2019 largely related to filgotinib in other inflammatory
diseases as providing additional value adding opportunities to achieve
our 12-month price target.

Catalyst rich in 2019. Outside of filgotinib in RA, the most significant
remaining catalysts in 2019 are top-line readouts from Phase 2 proofof-
concept trials for filgotinib in Sjögren’s disease and cutaneous lupus
erythematosus that are expected in 2H19. We expect a Phase III trial
initiation for filgotinib in psoriatic arthritis that was guided to begin in
2H19. We also expect GLPG to complete enrollment in the Phase 2
PINTA trial for GLPG1205 in idiopathic pulmonary fibrosis (IPF) and in
the Phase 2 ROCCELLA, to initiate a Phase 2 proof of concept trial for
its first generation Toledo molecule GLPG3312, and to initiate a Phase 1
trial for its second generation Toledo molecule GLPG3370. 1H20 will be
headlined by top-line results from the Phase 2b/3 SELECTIVITY trial for
filgotinib in UC.

INVESTMENT THESIS
Filgotinib’s superior safety profile versus other JAKi’s makes it a potentially best-in-class JAKi that has an opportunity to compete with anti-TNF agents in RA and IBD. We believe GLPG has a potential best-in-care drug in GLPG1690 that has the potential to become the standard of care
in IPF treatment. With limited effective treatments in IPF, GLPG1690 carries blockbuster potential with a projected 2022 market launch. While we view gaining approval to treat OA highly unlikely given the history of clinical efforts, we cannot ignore the massive opportunity should GLPG1972 gain regulatory approval.
We expect GLPG’s proprietary discovery platform to continue to produce uniquely profiled drugs that will keep the doors open to partnership opportunities.

VALUATION
Our $150 PT was determined using a Sum of the parts valuation that applied a WACC calculated 11.9% discount rate and 2% terminal growth rate to revenues and cash flows projected into 2028. Revenues for each asset were adjusted independently twice: by probability of regulatory approval, and by asset specific commercial profile.
A commercial probability distribution was determined based on a revenue weighted distribution of independent commercial scenarios projected for each drug candidate. GLPG1690 and filgotinib comprise a majority of the valuation. Galapagos held €1.3B in cash and cash equivalents as of
the end of 4Q18. Pro forma cash was not applied to this valuation.
[verwijderd]
0
Thanks voor het delen, avantiavanti.

Het OA programma is op het forum nog niet uitgebreid besproken. De plaats van het target ADAMTS-5 in het veld, en in het verlengde daarvan: wat er valt te zeggen over GLPG1972. Een tijd terug heb ik er het een en ander over gelezen. De kans van slagen lijkt me klein, maar wel groter dan ''hoogst onwaarschijnlijk''.
holenbeer
0
quote:

avantiavanti schreef op 29 januari 2019 15:21:

Wat laat bedenk ik me dat een nieuwe draad voor 2019 waarschijnlijk handig is.

Een goed moment om iedereen te bedanken voor de waardevolle feedback op de rapporten en updates.

Op naar de Finches en alles wat 2019 verder gaat brengen!
Jij ook erg bedankt! Waardevol werk!
avantiavanti
11
Berenberg 12 april 2019

Filgotinib clears big hurdle; target to EUR140

Raising price target to €140 from €112; reiterating Buy rating. We recently hosted Galapagos’ Chief Medical Officer (CMO) Walid Abi-Saab and IR Director Sofie Van Gijsel in Edinburgh, UK; since then, Galapagos reported Q418 earnings results and positive Phase III data (FINCH 1 and 3) on lead product candidate filgotinib for rheumatoid arthritis (RA). We have come away from the meetings, our follow-up with Galapagos, and discussions with KOLs with a much more confident view of Galapagos’ pipeline, which drives our price target increase to €140 (from €112).

To us, filgotinib has an important role in the RA treatment paradigm. The efficacy of the JAK inhibitors in RA is well documented; unfortunately, so are the safety issues, particularly at higher doses, specifically with DVT/PE (clotting events) that can cause deaths. Importantly, in the FINCH program, filgotinib generated efficacy rates of ACR20/50/70 that compare well with other JAKs, but with just one DVT/PE event. Together with lower rates of serious infections, herpes zoster (which can cause shingles), malignancies, and deaths compared to other JAKs, we think filgotinib has a strong case to make with clinicians, payers, and patients that it has competitive efficacy with best-in-class safety among the JAKs. We think a peak share of more than 25% among the JAKs in RA is probable. We expect regulatory filings in the EU and Japan prior to the U.S., which requires additional data from a testicular toxicity safety study (MANTA) prior to a filing. The MANTA data will eventually be submitted to all regulators.

Recent enrollment expansion should accelerate the MANTA readout. Gilead is conducting the safety study in the U.S. (MANTA 1) in males aged 25-55 years with moderately to severely active ulcerative colitis (UC); Gilead recently announced efforts to accelerate enrollment. In addition, Galapagos recently initiated a safety study in the EU (MANTA 2) in males aged 21-65 with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), or non-radiographic axial spondyloarthritis (nrAxSpA). Global regulators will apparently allow Gilead/Galapagos to aggregate data generated from MANTA 1 and 2, which we think should accelerate the readout on this next key hurdle for filgotinib.

We think filgotinib for RA will be approved in 2020. We think approval in the EU prior to the U.S. is possible, depending on how discussions go with regulators; we assume probability of success at 90% (vs. prior 75%). We also fine-tuned our share assumptions for filgotinib in RA and other indications, extended our model to 2035, and assume loss of exclusivity in 2034. We forecast peak un-risk adjusted revenues of at least $5bn (vs. prior $4bn); risk-adjusted, we estimate filgotinib is worth €76/share (vs. prior €51/share).

We value Galapagos based on our DCF and SOTP models. The key risks to our thesis are clinical data readouts on various programs, including filgotinib, GLPG1690, GLPG1972, and MOR106.



Patrick R. Trucchio, CFA
Analyst

Shanshan Xu, M.D., Ph.D.
Analyst
avantiavanti
6
Cantor Fitzgerald 1 april 2019

Rating: Overweight
Price Target: $130.00

Physician Call Takes: Strong Filgotinib Data are Supportive of Opp'y in RA and Beyond
Bijlage:
avantiavanti
9
Jefferies 29 april 2019

PRICE TARGET (PT) €130.00 (from €120.00)

Uneventful 1Q Financials; Eagerly Await FDA Need
for MANTA Around Mid-Year


deel 1
Bijlage:
Wall Street Trader
4
Key Takeaway

We (* Jefferies International Limited) hosted the Galapagos CMO in London.

Renewed interest in filgotinib combinations under new Gilead CEO

Gilead's new CEO Daniel O'Day visited Galapagos within a month of taking the
helm. There is now renewed interest in filgotinib combinations, including with BTK inhibitors.
Separately, management noted that the development spend cap on the 20% of R&D costs that GLPG co-funds is "within sight".

IPF could be the first go-it-alone indication for Galapagos

The Phase III ISABELA programme evaluating GLPG1690 in lung fibrosis (IPF) is
ongoing with 230 sites globally to enrol 1,500 patients. Recruitment is estimated to take around 24 months, implying data potentially 1H22E, with management expecting to provide an update in 3Q19E. The trial includes a futility analysis when 25% of patients have completed 12 months of treatment.

Secret Toledo target could be disclosed within 9-12 months

The target of the Toledo compounds will remain undisclosed until Phase II trials are initiated, with the first of a series of Phase II trials that may run in parallel potentially commencing by YE19/1Q20 in IBD. Phase I data for GLPG3312 are expected in 2H19E.

PRICE TARGET (PT) €130.00
avantiavanti
4

H.C. Wainwright&C0 29 april 2019

Post-FINCH the Story Is Centered on Maturing Pipeline and
Timing of Regulatory Filings With a Slew of Events During 2H19
Bijlage:
avantiavanti
9

Barclays 30 april 2019
Samenvatting update.

Roadshow recap - blue skies ahead

Stock Rating: Overweight
Industry View: Positive
Price Target: EUR 140.00
Price (26-Apr-2019): EUR 100.55
Potential Upside/Downside: +39.2%
Tickers: GLPG NA / GLPG.AS

We update following Galapagos' 1Q19 earnings report (see: 1Q19 first take: in-line result; awaiting filgotinib filing update (25/04/19)) and having hosted CEO Onno van de Stolpe for a day of meetings in London. We'd characterise management's tone as optimistic as ever with regards to the commercial potential for filgotinib following last month's release of the FINCH 1 & 3 datasets (see: Birds that aren't meant to be caged (01/04/19)). Whilst many of our assumptions around timing will hinge on the outcome of the forthcoming pre-NDA meeting (to be held likely before the end of 2Q19), management did point out that in RA, ~80% of the patient population is female and the vast majority of the male population is over the age of 60, thus it's possible that the full MANTA study may not be needed to file in this indication. In any event, commercial preparation is underway in both the US and Europe and GLPG noted that GILD's new management team views filgotinib as a critical asset within its pipeline and we expect more positive commentary to come (GILD reports 1Q19 on 2nd May). Whilst GLPG is still analysing the data from the FINCH programmes (with more data to be presented at the EULAR conference on 12-15 June), the company's rationale for why placebo/control responses may have been higher in 1& 3 vs. other JAKi trials makes sense to us (i.e. lower SOC treatment in E. Europe & S. Asia trial locations keeping more patients in the trials); in any event, the asset's key differentiating factor will likely be its safety profile. In terms of other programmes, we'll get an update on '1690 & the ISABELA trials after the summer and 1st ph. 1 data for TOLEDO assets will come in 2H19. With the company on track to likely have both the 100mg and 200mg filgotinib doses approved (and will be the only JAKi with two doses approved) and without a boxed warning for thrombosis, we continue to believe filgotinib is likely the best asset in the class and we reiterate our OW rating and €140 PT.

Model changes: We reduce our revenue forecasts in 2019 and 2020 to reflect the CF programme having been transferred to Abbvie. Most all else is unchanged.

Valuation & catalysts: Our €140 PT is based on our NPV (10% WACC; -1% TGr). Catalysts: GILD 1Q19 results (2nd May), filgotinib NDA filing (est. 4Q19), PoC data in Sjögren's & CLE (2H19), ISABELA update (2H19).
avantiavanti
5
avantiavanti
10
H.C.Wainwright&CO 23 mei 2019

IPF in Vogue With Multiple Phase 3's: Overview and Perspectives
Bijlage:
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