- Half-year 2023 key financials
- Group revenues of €328.8 million
- Jyseleca® net sales of €54.3 million
- Cash and current financial investments of €3.9 billion
on 30 June 2023
- Full year 2023 net sales guidance for Jyseleca® lowered
to €100-€120 million – 2023 cash burn guidance of €380-€420 million
reiterated
- Oncology pipeline update – continued progress with
point-of-care manufactured CAR-T candidates in hemato-oncology,
including approval of the clinical trial application in Europe for
BCMA CAR-T candidate in multiple myeloma
- Immunology pipeline update – start of Phase 3 study
with filgotinib in axial spondyloarthritis; start of Phase 2 study
with GLPG3667 in dermatomyositis; clinical trial application in
Europe for CAR-T candidate in refractory systemic lupus
erythematosus
- Implemented R&D strategy focused on best-in-class
medicines to accelerate innovation and time-to-patients – over 10
differentiated discovery programs across multiple modalities in
immunology and oncology initiated
- Appointed Thad Huston as Chief Financial Officer (CFO)
and Chief Operating Officer (COO)
- Appointed Dr. Susanne Schaffert as non-executive
independent Director to the Board of Directors
Webcast presentation
tomorrow, 4 August 2023, at 14:00
CET / 8:00 am ET,
www.glpg.com
Mechelen, Belgium; 3 August 2023, 22:01 CET;
regulated information – Galapagos NV (Euronext &
NASDAQ: GLPG) today announced its first half-year 2023 financial
results, a year-to-date business update and its outlook for the
remainder of 2023. The results are further detailed in the H1 2023
financial report available on the financial reports section of the
corporate website.
“The market and competitive landscape for the JAK class in
Europe has changed significantly over the past six months,
negatively impacting net sales of Jyseleca® and leading us to
revise our 2023 net sales guidance for Jyseleca® in rheumatoid
arthritis and ulcerative colitis from €140-€160 million to
€100-€120 million. In response to that, we are in the process of
evaluating various strategic options for Jyseleca®. We have a
strong cash position of €3.9 billion and we will continue to deploy
our resources in our strategic areas of immunology and oncology,
including externally sourced innovative product candidates, to
further build and expand our portfolio. Despite lower than
anticipated net sales for Jyseleca®, we reiterate our cash burn
guidance of €380-€420 million,” said Thad Huston, CFO and COO of
Galapagos.
Dr. Paul Stoffels1, CEO and Chairman of Galapagos added: “Our
commitment to providing transformational medicines to patients
worldwide remains our core focus. We have successfully implemented
our R&D strategy focused on best-in-class medicines to
accelerate innovation, aiming to generate short and long-term value
for all our stakeholders. We are actively building a differentiated
discovery pipeline of best-in-class small molecules, CAR-T cell
therapies and biologicals in our core areas of immunology and
oncology. In addition, our ongoing clinical programs across our
therapeutic areas are progressing well, and we are optimistic about
the global potential of our point-of-care CAR-T cell therapy
portfolio in hematological malignancies. Furthermore, in
immunology, we have continued to expand our clinical pipeline of
small molecules, while leveraging our CAR-T capabilities to start
clinical development in refractory systemic lupus erythematosus
with a CD19 CAR-T candidate.”
Half-Year 2023 operational
performanceImmunology portfolio
- Jyseleca®
(filgotinib) (JAK1)
- Jyseleca® is reimbursed for rheumatoid arthritis (RA) and
ulcerative colitis (UC) in 19 and 18 countries respectively. Sobi2,
our distribution and commercialization partner in Eastern
and Central Europe, Portugal, Greece, and the Baltic
countries, launched Jyseleca® in Czech Republic and Poland in UC
and in Croatia in RA. The commercial launch of Jyseleca® in Poland
resulted in a €1 million milestone receivable for us in the first
half of 2023.
- The European Commission endorsed the recommendation of the
Pharmaceutical Risk Assessment Committee (PRAC) to add measures to
minimize risks of serious side effects with the JAK inhibitor class
of medicines used for chronic inflammatory disorders. The product
information for all JAK inhibitors has been updated accordingly to
include these recommendations and warnings.
- We dosed the first patients in the pivotal Phase 3 OLINGUITO
study in axial spondyloarthritis (AxSpA).
- Based on the topline results from the Phase 3 DIVERSITY study
in Crohn’s disease (CD), we decided not to submit a Marketing
Authorization Application (MAA) in Europe in this indication and
not to proceed with the MAA for filgotinib in UC in
Switzerland.
- We presented various data abstracts at the annual ECCO and
EULAR congresses in Europe.
- Our pipeline assets
- First patients dosed in the Phase 2 GALARISSO study with oral,
selective tyrosine kinase 2 (TYK2) inhibitor, GLPG3667, in
dermatomyositis (DM).
- Clinical trial application (CTA) filed to start clinical
development of a CD19 CAR-T candidate in patients with refractory
systemic lupus erythematosus (rSLE).
- Multiple small molecules programs initiated to further build
our research pipeline.
Oncology portfolio
- We are encouraged by the initial safety, efficacy and
point-of-care feasibility results we have observed in the Phase 1/2
studies with our CD19 CAR-T candidates, GLPG5101 and GLPG5201,
which underscore the potential global transformational impact our
differentiated approach to CAR-T cell therapy could have on
patients.
- GLPG5101 in relapsed/refractory non-Hodgkin's lymphoma
(rrNHL)
- We are in the final stages of the Phase 1 part of the ongoing
Phase 1/2 ATALANTA-1 study, which enrolled patients with diffuse
large B cell lymphoma, mantle cell lymphoma and indolent lymphoma.
To generate a robust data package that is informative for further
development, we have decided to include more patients of certain
subpopulations in the Phase 1 dose-escalation cohort of
ATALANTA-1.
- The first patients with indolent lymphoma and mantle cell
lymphoma in the Phase 2 dose-expansion part of ATALANTA-1 have been
dosed.
- GLPG5201 in relapsed/refractory chronic lymphocytic
leukemia (rrCLL), with or without Richter’s transformation
(RT)
- We presented promising interim safety, efficacy and
point-of-care manufacturing data from 7 eligible patients3 of the
ongoing Phase 1/2 EUPLAGIA-1 study at two major scientific meetings
in Europe: objective response rate of 100%; no cytokine release
syndrome higher than grade 2, or immune effector cell-associated
neurotoxicity syndrome observed.4
- We are recruiting the last patients in the Phase 1
dose-escalation part of EUPLAGIA-1 and preparations to start the
Phase 2 dose-expansion cohort of the study are ongoing.
- We initiated multiple programs spanning various drug
modalities, including biologicals, CAR-T cell therapies and small
molecules, to further build our research pipeline.
Corporate update
- At the Annual General Meeting held on 25 April 2023, all
proposed resolutions were approved.
- The Board of Directors created 1,975,000 subscriptions rights
under new subscription right plans.
- Thad Huston was appointed as Chief Financial Officer (CFO) and
Chief Operating Officer (COO), succeeding Bart Filius, per 1 July
2023.
- The Board of Directors appointed Dr. Susanne Schaffert as
non-executive independent Director by way of co-optation on 12 June
2023, replacing Dr. Rajesh Parekh who stepped down on 10 June
2023.
- We completed the integrated drug discovery collaboration
transaction with NovAliX on 30 June 2023, effective as from 1 July
2023. Under the terms of the agreement, Galapagos’ drug discovery
and research activities conducted in Romainville, France, and
Galapagos’ employees in Romainville, which are exclusively
dedicated to the operation of these activities, are transferred to
NovAliX who will assume all ongoing research and discovery
activities in Romainville. In return, Galapagos is committed to
utilizing the research capabilities and expertise of NovAliX
through a five year-collaboration and within the context of the
company’s R&D portfolio.
First
half-year 2023 financial highlights (unaudited)
(€ millions, except basic &
diluted income/loss (-)
per share)
|
Six months ended 30 June |
Change |
|
2023 |
2022 |
Product net sales |
54.3 |
35.4 |
+54% |
Collaboration revenues |
274.5 |
238.6 |
+15% |
Total net revenues |
328.8 |
274.0 |
+20% |
Cost of sales |
(7.8) |
(5.5) |
+41% |
R&D expenditure |
(211.9) |
(249.5) |
-15% |
G&Aii and S&Miii expenses |
(121.6) |
(134.0) |
-9% |
Other operating income |
23.8 |
17.6 |
+35% |
Operating profit/loss (-) |
11.3 |
(97.5) |
|
Fair value adjustments and net currency exchange differences |
0.2 |
71.9 |
|
Net other financial result |
30.4 |
(4.3) |
|
Income taxes |
(13.6) |
(2.5) |
|
Net profit/loss (-) of the period |
28.3 |
(32.3) |
|
Basic and diluted income/loss (-) per share (€) |
0.43 |
(0.49) |
|
Current financial investments and cash and cash
equivalents |
3,874.9 |
4,429.0 |
|
Details of the first half-year 2023 financial
resultsTotal net revenues for the six
months ended 30 June 2023 was €328.8 million, compared to €274.0
million for the six months ended 30 June 2022, and consisted
of:
- Product net sales of
Jyseleca® in Europe for the first six months of
2023 amounting to €54.3 million (€35.4 million in the first
half-year of 2022).
- Collaboration revenues of €274.5 million for
the first six months of 2023, compared to €238.6 million for the
first six months of 2022.
Collaboration revenues increased mainly due to revenue
recognition related to the collaboration agreement with Gilead for
the filgotinib development amounting to €154.9 million in the first
six months of 2023 compared to €115.3 million for the same period
last year. This increase is primarily driven by a positive catch up
of revenue explained by a decrease in the total estimated remaining
costs to complete the filgotinib development. This was a
consequence of the topline results from Phase 3 DIVERSITY trial of
filgotinib in CD and our decision not to submit a Marketing
Authorization Application in Europe.
Our deferred income balance on 30 June 2023 includes €1.4
billion allocated to our drug discovery platform that is recognized
linearly over the remaining period of our 10-year collaboration,
and €0.3 billion allocated to the filgotinib development that is
recognized over time until the end of the development period.
Total operating profit for the six months ended
30 June 2023 was €11.3 million, compared to total operating loss of
€97.5 million for the first six months ended 30 June 2022.
- Cost of sales related to
Jyseleca® net sales in the first six months of
2023 amounted to €7.8 million (€5.5 million in the first half-year
of 2022).
- R&D expenditure in the first six months of
2023 amounted to €211.9 million, compared to €249.5 million for the
first six months of 2022. This decrease was primarily explained by
an impairment recorded in the first six months of 2022 of €26.7
million of previously capitalized upfront fees related to our
collaboration with Molecure on the dual chitinase inhibitor OATD-01
(GLPG4716), as well as by decreased personnel and subcontracting
costs.
- S&M and G&A expenses
amounted to €121.6 million in the first six months of 2023,
compared to €134.0 million in the first six months
of 2022. This decrease was primarily due to a decrease in
personnel costs and agency deliverables.
- Other operating income amounted to €23.8
million in the first six months of 2023, compared to
€17.6 million for the same period last year.
Net financial income in the first six months of
2023 amounted to €30.6 million, compared to net financial
income of €67.7 million for the first six months of 2022.
- Fair value adjustments and net currency exchange
differences in the first six months of 2023 amounted to
€0.2 million, compared to fair value adjustments and net
currency exchange gains of €71.9 million for the first six
months of 2022, and were primarily attributable to €11.4 million of
unrealized currency exchange losses on our cash and cash
equivalents and current financial investments at amortized cost in
U.S. dollars, offset by €12.7 million of positive changes in (fair)
value of current financial investments.
- Net other financial income in the first six
months of 2023 amounted to €30.4 million, compared to net
other financial expenses of €4.3 million for the first six
months of 2022, and was primarily attributable to €33.4 million of
interest income, which increased significantly due to the increase
in interest rates.
We reported a group net profit for the first
six months of 2023 of €28.3 million, compared to a group net loss
of €32.3 million for the first six months of 2022.
Cash position Current financial
investments and cash and cash equivalents totaled €3,874.9 million
on 30 June 2023, as compared to €4,094.1 million on 31 December
2022.
Total net decrease in cash and cash equivalents and
current financial investments amounted to €219.1 million
during the first six months of 2023, compared to a net decrease of
€274.2 million during the first six months of 2022. This net
decrease was composed of (i) €224.3 million of operational cash
burn, (ii) €9.3 million of mainly negative exchange rate
differences, offset by (iii) €1.8 million of cash proceeds from
capital and share premium increase from exercise of subscription
rights in the first six months of 2023, and (iv) €12.7 million
positive changes in (fair) value of current financial
investments.
Outlook 2023Financial
outlook
- In response to the changing market dynamics and the competitive
landscape for the JAK class in Europe, we are in the process of
evaluating various strategic options for Jyseleca® and have lowered
our net 2023 sales guidance for Jyseleca® in RA and UC to €100-€120
million, compared to €140-160 million initially guided in our full
year 2022 results in February.
- Despite the lower than anticipated net sales for Jyseleca®, we
reiterate our full year 2023 cash burn guidance in the range of
€380-€420 million. We will continue to focus on expanding our
portfolio and will deploy our resources in our strategic core areas
of immunology and oncology.
R&D outlook
- Immunology portfolio
- We expect to announce Phase 4 results from the FILOSOPHY
real-world evidence study of filgotinib in patients with RA at a
future scientific conference (subject to abstract acceptance) and
to initiate the Phase 2 pediatric study in patients with juvenile
arthritis later this year.
- We aim to start dosing patients with SLE in the Phase 2
GALACELA study of oral, selective TYK2 inhibitor, GLPG3667.
- Following the potential approval of the CTA submitted in Europe
for CD19 CAR-T candidate, GLPG5101, in patients with rSLE, we
expect to open the clinical centers in the coming months.
- Oncology portfolio
- As we continue to build a solid data package, we aim to release
an update on the ATALANTA-1 and EUPLAGIA-1 Phase 1 studies with
GLPG5101 and GLPG5201 in rrNHL and rrCLL respectively later this
year. We intend to present detailed data at a forthcoming
hematology scientific conference (subject to abstract acceptance)
before year-end.
- The Phase 1 part of EUPLAGIA-1 study with GLPG5201 is close to
completion and we aim to initiate the Phase 2 dose-expansion cohort
in the first half of 2024.
- In the first half of 2024, we anticipate submitting an
investigational new drug application (IND) in the US to start
clinical development with our CD19 CAR-T program.
- We expect to start the Phase 1/2 PAPILIO-1 study with BCMA
CAR-T candidate, GLPG5301, in relapsed/refractory multiple myeloma
(rrMM) after summer5.
Business development
- We continue to explore additional business development
opportunities to further leverage our internal capabilities and
expand our portfolio in our core areas of growth and value
creation.
First half-year 2023 financial reportGalapagos’
financial report for the first six months ended 30 June 2023,
including details of the unaudited consolidated results, is
accessible on the financial reports section of our website.
Conference call and webcast presentationWe
will host a conference call and webcast presentation tomorrow 4
August 2023, at 14:00 CET / 8:00 am ET. To participate in the
conference call, please register in advance using this link, after
which the dial-in numbers will be provided. The conference call can
be accessed 10 minutes prior to the start by using the conference
access information provided in the email after registration, or by
selecting the “call me” feature.
The live webcast is available on glpg.com or via the following
link. The archived webcast will be available for replay shortly
after the close of the call on the investor section of the
website.
Financial calendar 2023
2 November
2023 22 February 2024 |
Third quarter
2023 results Full year 2023 results |
(webcast 3
November 2023) (webcast 23 February 2024) |
About GalapagosGalapagos is a fully integrated
biotechnology company united around a single purpose: to transform
patient outcomes through life-changing science
and innovation for more years of life and quality of
life. We focus on the key therapeutic areas of immunology and
oncology, where we have developed deep scientific expertise in
multiple drug modalities, including small molecules and cell
therapies. Our portfolio comprises discovery through to
commercialized programs and our first medicine for rheumatoid
arthritis and ulcerative colitis is currently available in Europe
and Japan. For additional information, please
visit www.glpg.com or follow us
on LinkedIn or Twitter.
Contact
Media inquiries: Marieke Vermeersch +32 479
490 603 media@glpg.com |
Investor inquiries: Sofie Van Gijsel +1 781
296 1143ir@glpg.com Sandra Cauwenberghs +32 495 58 46
63 ir@glpg.com |
Forward-looking statementsThis release may
contain forward-looking statements, all of which involve
certain risks and uncertainties. These statements are often, but
are not always, made through the use of words or phrases
such as “anticipate,” “believe,” “progress,” “further,” “expect,”
“encouraging,” “long-term,” “plan,” “could,” “estimate,” “will,”
“continue,” “aim,” “intend,” “future,” “guidance,” “outlook,”
“progress,” “forward” as well as similar
expressions. Forward-looking statements contained in this
release include, but are not limited to, statements made in
the sections captioned “Half-Year 2023 operational performance” and
“Outlook 2023”, the guidance from management regarding our
financial results (including guidance regarding the expected
operational use of cash and adjusted net sales guidance for
Jyseleca® during the financial year 2023), statements regarding our
strategy and plans, including our strategic and capital allocation
priorities, statements regarding the transfer of our drug and
research activities and employees exclusively dedicated to the
activities in Romainville (France), statements regarding the five
year-collaboration between Galapagos and NovAliX, statements
regarding the global R&D collaboration with Gilead, statements
regarding the amount and timing of potential future milestones, and
other payments, statements regarding our strategic R&D plans,
including progress on our immunology or oncology portfolio, our
CAR-T-portfolio and our SIKi-portfolio, and potential changes of
such plans, statements regarding our pipeline and complementary
technology platforms facilitating future growth, statements
regarding the expected timing, design and readouts of ongoing and
planned preclinical studies and clinical trials, including but not
limited to (i) filgotinib in RA, UC and AxSpA, (ii) with SIKi
compounds, including GLPG3667 in SLE and DM, (iii) GLPG5101 in
rrNHL and rSLE, (iv) GLPG5201 in rrCLL and rrSLL, and (v) GLPG5301
in rrMM, including recruitment for trials and topline results for
our trials and studies in our portfolio, statements relating to
interactions with regulatory authorities, the timing or likelihood
of additional regulatory authorities’ approval of marketing
authorization for filgotinib for RA, UC or any other indication for
filgotinib, statements regarding our commercialization efforts for
filgotinib, our product candidates, and any of our future approved
products, statements regarding our expectations on commercial sales
of filgotinib and any of our product candidates (if approved),
statements related to the EMA’s safety review of JAK inhibitors
used to treat certain inflammatory disorders, including filgotinib,
initiated at the request of the European Commission (EC) under
Article 20 of Regulation (EC) No 726/2004 and regarding the related
CHMP opinion and EC’s decision, statements regarding the timing or
likelihood of pricing and reimbursement interactions for
filgotinib, statements relating to the development of our
commercial organization, statements and expectations regarding
commercial sales for filgotinib, statements regarding our plans and
strategy related to the development of our CD19 CAR-T candidates,
GLPG5101 and GLPG5201, including patient enrollment for the Phase
1/2 ATALANTA-1 study and the EUPLAGIA-1 study, and the timing for
topline results from such studies, statements regarding the timing
for initiation of, the Phase 1/2 PAPILIO-1 study with BCMA CAR-T
candidate, GLPG5301, statements regarding the timing and likelihood
of business development projects and external innovation, and
statements regarding the changes in our leadership and expected
resulting benefits. Any forward-looking statements in this release
are based on management’s current expectations and beliefs and are
not guarantees of future performance. Forward-looking statements
involve known and unknown risks, uncertainties and other factors
which might cause our actual results, financial condition and
liquidity, performance or achievements to be materially different
from any historic or future results, financial conditions and
liquidity, performance or achievements expressed or implied by such
forward-looking statements. Such risks include, but are not limited
to, the risk that our expectations regarding our 2023 revenues,
operating expenses, cash burn and other financial results may be
incorrect (including because one or more of our assumptions
underlying our revenue and expense expectations may not be
realized), the risk that ongoing and future clinical trials may not
be completed in the currently envisaged timelines or at all, the
inherent risks and uncertainties associated with competitive
developments, clinical trials, recruitment of patients, product
development activities and regulatory approval requirements
(including the risk that data from our ongoing and planned clinical
research programs in RA, UC, DM, SLE, AxSpA, refractory/relapsed
NHL, rrCLL, refractory/replapsed small lymphocytic lymphoma, rrMM
and other immunologic indications or any other indications or
diseases, may not support registration or further development of
our product candidates due to safety or efficacy concerns or other
reasons), risks related to the acquisitions of CellPoint and
AboundBio, including the risk that we may not achieve the
anticipated benefits of the acquisitions of CellPoint and
AboundBio, risks related to the transfer of the drug discoveries
and research activities conducted in Romainville (France) and
employees exclusively dedicated to these activities to NovAliX, the
inherent risks and uncertainties associated with target discovery
and validation and drug discovery and development activities, the
risk that the preliminary and topline data from the OLINGUITO,
ATALANTA-1, EUPLAGIA-1, GALARISSO, PAPILIO-1, FILOSOPHY, and
GALACELA-studies may not be reflective of the final data, risks
related to our reliance on collaborations with third parties
(including, but not limited to, our collaboration partner Gilead,
Sobi and Lonza), risks related to the implementation of the
transition of the European commercialization responsibility of
filgotinib from Gilead to us, including the transfer of the supply
chain, and the risk that the transition will not have the currently
expected results for our business and results of operations, the
risk that our plans with respect to our CAR-T programs may not be
achieved on the currently anticipated timeline or at all, the risk
that our estimates of the commercial potential of our product
candidates or expectations regarding the costs and revenues
associated with the commercialization rights may be inaccurate, the
risk that we will not be able to continue to execute on our
currently contemplated business plan and/or will revise our
business plan, the risks related to our strategic transformation,
including the risk that we may not achieve the anticipated benefits
of such exercise on the currently envisaged timeline or at all, the
risk that we will be unable to successfully achieve the anticipated
benefits from our leadership transition, the risk that we will
encounter challenges retaining or attracting talent, risks related
to potential disruptions in our operations, supply chain or ongoing
studies due to the conflict between Russia and Ukraine, the risk
that the EMA may impose JAK class-based warnings, and the risk that
the EMA’s safety review may negatively impact acceptance of
filgotinib by patients, the medical community, and healthcare
payors, the risk that regulatory authorities may require additional
post-approval trials of filgotinib or any other product candidates
that are approved in the future, and the risks and uncertainties
relating to the impact of the COVID-19 pandemic. A further
discussion of these risks, uncertainties and other risks can be
found in our filings and reports with the Securities and Exchange
Commission (SEC), including in our most recent annual report on
Form 20-F filed with the SEC and other filings and reports filed by
Galapagos with the SEC. Given these risks and uncertainties, the
reader is advised not to place any undue reliance on such
forward-looking statements. In addition, even if our results,
performance, financial condition and liquidity, and the development
of the industry in which we operate are consistent with such
forward-looking statements, they may not be predictive of results
or developments in future periods. These forward-looking statements
speak only as of the date of publication of this release. We
expressly disclaim any obligation to update any such
forward-looking statements in this release unless required by law
or regulation.
1 Throughout this press release, ‘Dr. Paul Stoffels’ should be
read as ‘Dr. Paul Stoffels, acting via Stoffels IMC BV’2 Swedish
Orphan Biovitrum AB3 Cut-off date for efficacy and safety analysis:
9 January 20234 As published in the press release of February 9,
2023: Galapagos presented encouraging initial safety and
efficacy data at 2023 EBMTEHA for point-of-care manufactured CAR-T
candidate, GLPG5201, in rrCLL5 CTA for GLPG5301 in BCMA was
approved in May 2023
i The operational cash burn (or operational cash flow if this
liquidity measure is positive) is equal to the increase or decrease
in our cash and cash equivalents (excluding the effect of exchange
rate differences on cash and cash equivalents), minus:
- the net proceeds, if any, from share capital and share premium
increases included in the net cash flows generated from/used in (-)
financing activities
- the net proceeds or cash used, if any, in acquisitions or
disposals of businesses; the movement in restricted cash and
movement in current financial investments, if any, the cash
advances and loans given to third parties, if any, included in the
net cash flows generated from/used in (-) investing activities
- the cash used for other liabilities related to the acquisition
of businesses, if any, included in the net cash flows generated
from/used in (-) operating activities.
This alternative liquidity measure is in our view an important
metric for a biotech company in the development stage. The
operational cash burn for the six months ended 30 June 2023
amounted to €224.3 million and can be reconciled to our cash flow
statement by considering the decrease in cash and cash equivalents
of €409.8 million, adjusted by (i) the cash proceeds from capital
and share premium increase from the exercise of subscription rights
by employees for €1.8 million, and (ii) the net purchase of current
financial investments amounting to €187.2 million.ii General and
administrative iii Sales and marketing
- Galapagos announces first half-year 2023 financial results
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