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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.