Galapagos announces full year 2022 results and outlook for 2023
Key 2022 and
post-period events
- Dr. Paul Stoffelsi appointed as
Chief Executive Officer and Chairman of the Board of Directors
- Implemented new strategic direction
to accelerate innovation and time-to-patients:
- Set-up of new innovation model and
fit-for-purpose R&D organization
- Focus on key therapeutic areas of
immunology and oncology
- Discontinuation of activities in
fibrosis and kidney disease
- Expansion of drug modalities beyond
small molecules, including biologicals and CAR-T
- Entered into the field of oncology
through the acquisitions of CellPoint and AboundBio
- Presented encouraging initial
safety and efficacy data from two ongoing Phase 1/2 studies in
patients with refractory/relapsed non-Hodgkins lymphoma (NHL) and
chronic lymphocytic leukemia (CLL) with CD19 CAR-T candidates,
GLPG5101 and GLPG5201, manufactured at point-of-care
- Jyseleca® sales of €87.6 million,
at the upper end of the guidance of €80-90 million
- Jyseleca® reimbursed for rheumatoid
arthritis (RA) in 15 countries and for ulcerative colitis (UC) in
11 countries
- The Committee for Medicinal
Products for Human Use (CHMP) adopted the Pharmacovigilance Risk
Assessment Committee (PRAC)’s recommendation to harmonize the
European label of all approved JAK inhibitors for chronic
inflammatory disorders following an extensive safety review
(Article 20 procedure)
- Received positive opinion from the
CHMP for Jyseleca® European label update based on testicular
function safety data from MANTA/RAy semen parameter studies
- Announced topline results from
Phase 3 DIVERSITY trial of filgotinib in Crohn’s disease and, based
on these topline data, decided not to submit a Marketing
Authorization Application in Europe
2022 financial
results
- Group net revenues of €505.3
million compared to €484.8 million in 2021
- Operating loss of €267.5 million
compared to €165.6 million in 2021
- Net loss of €218.0 million compared
to €103.2 million in 2021
- Cash and current financial
investments of €4.1 billion on 31 December 2022
- Operational cash burnii of €513.8
million, which is within the guided range
Webcast
presentation
tomorrow,
24 February
2023, at
14.00 CET
/ 8 AM ET,
www.glpg.com
Mechelen, Belgium;
23 February
2023,
22.01 CET; regulated
information –
Galapagos NV (Euronext &
NASDAQ: GLPG) reports 2022
results, supported by
strong adoption of Jyseleca®
across Europe,
and provides outlook for
2023.
Commenting on the full year results 2022, Dr. Paul
Stoffels, CEO and Chairman of the Board of Directors of Galapagos
said: “As I reflect on my first year as the new CEO and Chairman,
we can be proud of what we have achieved in a very short time to
reset our organization and embrace a new R&D strategy for a
sustainable future. 2022 was a year of transformation and
change.
Adding oncology as a new strategic therapeutic
area, and CAR-T and biologicals as novel drug modalities, were key
steps in our transformation. Through the acquisitions of CellPoint
and AboundBio, we gained access to a breakthrough, point-of-care
CAR-T manufacturing platform, a clinical-stage CAR-T oncology
pipeline and a research engine for novel, differentiated CAR-T
constructs, that together have the potential to deliver life-saving
medicines to more patients, faster and more efficiently.
In addition, we remain fully committed to
immunology, an area where there is still significant unmet patient
need and for which we have built deep scientific know-how and
expertise since our founding. With our programs targeting multiple
modes-of-action and drug modalities, most recently including CAR-T,
we have a differentiated portfolio of preclinical through to
commercial assets.”
Bart Filius, President, COO and CFO of Galapagos,
added: “We are very proud that our first marketed medicine,
Jyseleca®, an orally administered JAK1 preferential inhibitor,
continued to deliver solid in-market performance with a growing
European base and €87.6 million in net sales for the year 2022,
reaching 18,000 patients with RA and UC across Europe. Based on the
topline results from the Phase 3 DIVERSITY study of filgotinib in
Crohn’s disease, Galapagos decided not to submit a Marketing
Authorization Application in Europe in this indication. On the
other hand, following the positive opinion from the Committee for
Medicinal Products for Human Use on the Type II variation
application based on the safety data on semen parameters from the
MANTA and MANTA-RAy studies, the European label for RA and UC has
been updated, potentially broadening access for European patients
who may benefit from this treatment. For 2023, we anticipate net
Jyseleca® sales in a range between €140 and €160 million. For the
longer term, we believe Jyseleca® can reach €400 million peak sales
in RA, UC and axial spondyloarthritis.
Financially, we ended 2022 with a strong balance
sheet of €4.1 billion in cash and current financial investments,
which provides us with the necessary means to look for additional
external innovation to accelerate our R&D portfolio while
progressing our internal programs. As part of our company
transformation, we have meaningfully reduced our cost base. We
anticipate our full year 2023 operating cash burn to decline to a
range of €380 to €420 million.”
2022 operational review and
post-period events
Jyseleca® commercial &
regulatory progress
- Adoption across Europe with
reimbursement for RA in 15 countries and for UC in 11
countries
- Sobi, our distribution and
commercialization partner in Eastern and Central Europe, Portugal,
Greece, and the Baltic countries, launched Jyseleca® in RA in the
Czech Republic and Portugal, resulting in €2.0 million milestone
payments to Galapagos
- The Medicines and Healthcare
products Regulatory Agency (MHRA) in Great Britain and the Ministry
of Health, Labour and Welfare (MHLW) in Japan approved filgotinib
200mg for the treatment of moderate to severe UC
- The European Medicines Agency’s
(EMA) Committee for Medicinal Products for Human Use, CHMP, adopted
the recommendation of the PRAC to add measures to minimize risk of
serious side effects with JAK inhibitors used for chronic
inflammatory disorders
- Positive opinion issued by the CHMP
for Jyseleca’s® European label update based on testicular function
safety data from MANTA/RAy semen parameter studies
Pipeline update
- Started preparations to initiate a
Phase 2 program with TYK2 inhibitor GLPG3667 in dermatomyositis
(DM) and systemic lupus erythematosus (SLE)
- Discontinued our
activities in fibrosis and kidney disease as a result of our new
strategic therapy area focus
- Phase 2 study with
GLPG2737 in polycystic kidney disease is ongoing with topline
results expected in the first half of 2023. If successful, we aim
to outlicense the program
- Halted development
of SIK3 inhibitor GLPG4399; medicinal chemistry activities to
identify SIK inhibitors with improved pharmacology continues
- Reported initial encouraging safety
and efficacy data at ASH1 2022 from the ongoing ATALANTA-1 Phase
1/2 study in refractory/relapsed NHL with CD19 CAR-T candidate,
GLPG5101, manufactured at point-of-care
Corporate update
- Appointed Dr. Paul Stoffels as
Chief Executive Officer, succeeding Onno Van de Stolpe, as of 1
April 2022. Following approval by Galapagos’ shareholders on 26
April 2022, adopted a 1-tier governance model and Dr. Paul Stoffels
was appointed Chairman of the Board of Directors
- Implemented new strategic direction
to accelerate innovation and time-to-patients, focused on key
therapeutic areas of immunology and oncology, diversifying beyond
small molecules to include CAR-T and biologicals, and set up of a
fit-for-purpose R&D organization
- Entered the field of oncology
through the acquisitions of CellPoint and AboundBio in all-cash
transactions against payment of an upfront amount of €125 million
for CellPoint, with an additional €100 million to be paid upon
achievement of certain milestones, and against payment of $14
million for AboundBio
- Received various transparency
notifications from EcoR1 Capital LLC and FMR LLC, indicating that
their shareholding in Galapagos increased, crossing the 5%
threshold, to 5.2% and 5.9% respectively, of our current
outstanding shares
- Raised €6.7 million through the
exercise of subscription rights
- Announced changes to the Executive
Committee: Dr. Walid Abi-Saab (Chief Medical Officer) and Dr. André
Hoekema (Chief Business Officer) retired from the company, and
Valeria Cnossen (General Counsel) and Annelies Missotten (Chief
Human Resources Officer) were appointed as new members of the
Executive Committee as of 1 January 2023
Post-period events
- Poster presentation at the annual
EBMT-EHA2 congress demonstrating initial encouraging safety and
efficacy results from the ongoing EUPLAGIA-1 Phase 1/2 study with
point-of-care manufactured CD19 CAR-T candidate, GLPG5201, in
patients with refractory/replapsed CLL and small lymphocytic
lymphoma (rrSLL), with or without Richter’s transformation (RT).
All 7 out of 7 eligible rrCLL patients, including 4 patients with
RT, responded to treatment (Objective Response Rate of 100%), and
GLPG5201 showed an acceptable safety profile with no cytokine
release syndrome (CRS) higher than grade 2, and no immune effector
cell-associated neurotoxicity syndrome (ICAN) observed
- Announced topline results from the
DIVERSITY study, a combined induction and maintenance Phase 3 study
of filgotinib in Crohn’s disease. While the co-primary endpoints
for filgotinib 200mg in the maintenance part of the study were met
and the observed safety profile is consistent with its known safety
profile, the two induction cohorts missed the co-primary endpoints
of clinical remission and endoscopic response at Week 10. Galapagos
decided not to submit a Marketing Authorization Application in
Europe based on these topline data
Financial performance
Key figures
2022
(consolidated)(€
millions, except basic & diluted
loss per share)
|
31 December 2022
group total |
31 December 2021
group total |
Product net sales |
87.6 |
14.8 |
Collaboration revenues |
417.7 |
470.1 |
Total net revenues |
505.3 |
484.8 |
Cost of sales |
(12.1) |
(1.6) |
R&D expenditure |
(515.1) |
(491.7) |
G&Aiii and S&Miv expenses |
(292.5) |
(210.9) |
Other operating income |
46.8 |
53.7 |
Operating loss |
(267.5) |
(165.6) |
Fair value adjustments and net exchange differences |
51.5 |
61.3 |
Net other financial result |
0.9 |
(18.7) |
Income taxes |
(2.8) |
(2.4) |
Net loss from continuing operations |
(218.0) |
(125.4) |
Net profit from discontinued operations |
|
22.2 |
Net loss of the period |
(218.0) |
(103.2) |
Basic and diluted loss per share (€) |
(3.32) |
(1.58) |
|
|
|
Current financial investments and cash and cash
equivalents |
4,094.1 |
4,703.2 |
Details of the financial resultsOur net
revenues in 2022 amounted to €505.3 million compared to €484.8
million in 2021.
We reported product net sales of Jyseleca® in
Europe in 2022 amounting to €87.6 million, compared to €14.8
million last year.
Cost of sales related to Jyseleca® net sales in
2022 amounted to €12.1 million, compared to €1.6 million in
2021.
Collaboration revenues amounted to €417.7 million
in 2022, compared to €470.1 million last year. The revenue
recognition linked to the upfront consideration and milestone
payments in the scope of the collaboration with Gilead for
filgotinib, amounted to €174.4 million in 2022 (compared to
€235.7 million in 2021). This decrease was due to a lower
increase in the percentage of completion, slightly offset by higher
revenue recognition of milestone payments, strongly influenced by
the milestone achieved in 2022 related to the regulatory approval
in Japan for UC.
On 8 February 2023 we announced topline results
from the Phase 3 DIVERSITY trial of filgotinib in Crohn’s disease
and, based on these topline data, decided not to submit a Marketing
Authorization Application in Europe. While this recent event will
not have an impact on our financial statements for the year ended
31 December 2022, we will provide further information in our 2022
annual report on the potential revenue recognition impact on our
financial statements for the year ended 31 December 2023.
The revenue recognition related to the exclusive
access rights granted to Gilead for our drug discovery platform
amounted to €230.4 million in 2022 (compared to €230.6 million in
2021). We also recognized royalty income from Gilead for Jyseleca®
for €10.7 million in 2022 (compared to €3.8 million in 2021).
Additionally, we recorded in 2022 milestone payments of €2.0
million triggered by the inital sales of Jyseleca® in Czech
Republic and Portugal by our distribution and commercialization
partner Sobi.
Our deferred income balance at 31 December 2022
includes €1.5 billion allocated to our drug discovery platform that
is recognized linearly over the remaining period of our 10-year
collaboration, and €0.5 billion allocated to the development of
filgotinib which is recognized over time until the end of
filgotinib’s development period.
Our R&D expenditure in 2022 amounted to
€515.1 million, compared to €491.7 million in 2021.
Depreciation and impairment costs in 2022 amounted to €54.5 million
(compared to €17.5 million in 2021). This increase was primarily
due to an impairment of €26.7 million of previously capitalized
upfront fees related to our collaboration with Molecure on the dual
chitinase inhibitor OATD-01 (GLPG4716) and impairments of
intangible assets related to other discontinued projects recorded
in 2022. Personnel costs increased from €165.2 million in 2021 to
€190.1 million in 2022 primarily related to increases in
restructuring costs and accelerated non-cash cost recognition for
subscription right plans related to good leavers. This was partly
offset by a decrease in subcontracting costs from €251.1 million in
2021 to €214.9 million in 2022 following the evolution of our
programs.
Our G&A and S&M expenses amounted to
€292.5 million in 2022, compared
to €210.9 million in 2021. This increase was
primarily due to the termination of our 50/50 filgotinib
co-commercialization cost sharing agreement with Gilead for
filgotinib in 2022 which explains €59.7 million of the variance.
The cost increase was also explained by an increase in personnel
costs of €26.6 million in 2022 compared to 2021, which are related
to an increase in our commercial work force driven by the
commercial launch of filgotinib in Europe, accelerated non-cash
cost recognition for subscription right plans related to good
leavers and restructuring costs.
Other operating income (€46.8 million in 2022
compared to €53.7 million in 2021) decreased, mainly driven by
lower grant and R&D incentives income.
We reported an operating loss amounting to €267.5
million in 2022, compared to an operating loss of €165.6 million in
2021.
Net financial income in 2022 amounted to
€52.4 million, compared to €42.6 million in 2021. Net
financial income in 2022 was primarily attributable to €41.3
million of unrealized currency exchange gains on our cash and cash
equivalents and current financial investments at amortized cost in
U.S. dollars, and to €6.9 million of positive changes in the (fair)
value of our current financial investments. The other financial
expenses also had the effect of discounting our non-current
deferred income of €7.7 million. Net interest income amounted to
€11.1 million in 2022 compared to €8.8 million of net interest
expense in 2021.
We reported a group net loss in 2022 of €218.0
million, compared to a group net loss of €103.2 million in
2021.
Cash
positionCurrent financial investments and cash and
cash equivalents totaled €4,094.1 million on 31 December 2022, as
compared to €4,703.2 million on 31 December 2021.
Total net decrease in cash and cash equivalents and
current financial investments amounted to €609.1 million in 2022,
compared to a net decrease of €466.1 million in 2021. This net
decrease was composed of (i) €513.8 million of operational cash
burn, offset by (ii) €6.9 million positive changes in (fair) value
of current financial investments and €44.5 million of mainly
positive exchange rate differences, (iii) €6.7 million of cash
proceeds from capital and share premium increase from exercise of
subscription rights in 2022, and (iv) €153.4 million cash out
from the acquisitions of CellPoint and AboundBio, net of cash
acquired.
Acquisition of
CellPoint
and AboundBioWe
have completed the initial accounting of the acquisitions of
Cellpoint and AboundBio, including the purchase price allocations.
Disclosures on the business combinations will be included in our
full year 2022 annual report.
Outlook 2023
Immunology
franchiseThis year, we expect additional
reimbursement decisions for Jyseleca® in UC in Europe, and we
anticipate that Sobi will further progress with reimbursement
discussions in RA and UC in Eastern and Central Europe, Greece, and
the Baltic countries. We also expect the final decision from the
European Commission following CHMP’s adoption of the recommendation
of the PRAC to harmonize the EU labels of all approved JAK
inhibitors. We plan to start a Phase 3 study in axial
spondyloarthritis, and anticipate announcing the initial results
from the FILOSOPHY Real-World Evidence Phase 4 study in RA.
We aim to recruit the first patients in the Phase 2
programs with our TYK2 inhibitor product candidate, GLPG3667, in DM
in the first quarter of 2023, followed by the start of a study in
SLE later this year.
To accelerate time-to-patients, we are diversifying
our drug modality capabilities in immunology and recently announced
that we aim to start clinical development with the CD19 CAR-T
candidate, GLPG5101, in refractory systemic lupus erythematosus
(rSLE).
Oncology portfolio Patient
recruitment in the European sites of the ATALANTA-1 Phase 1/2 study
with CD19 CAR-T candidate, GLPG5101, in rrNHL as well as in the
EUPLAGIA-1 study with CD19 CAR-T candidate GLPG5201 in rrCLL/SLL is
progressing. We aim to provide Phase 1 topline results from both
studies around mid-2023 and aim to include US patients in
2023.
We aim to expand the CAR-T portfolio with a BCMA
CAR-T product candidate, GLPG5301, in refractory/relapsed multiple
myeloma (rrMM) and aim to start enrolling patients in the PAPILIO-1
Phase 1/2 study in Europe in the second quarter of 2023.
Financial guidance For the full
year 2023, we anticipate further reduction of our cash burn and
anticipate landing between €380 and €420 million (compared to €514
million for the full year 2022), including the acceleration in
oncology. We also anticipate between €140 and €160 million net
sales of Jyseleca® for the full year 2023.
Taking into account multiple factors, we have
revised our estimates of the peak sales potential for Jyseleca® in
RA, UC and axial spondyloarthritis and expect this to reach €400
million by the end of the decade.
Annual report
2022We are currently finalizing the
financial statements for the year ended 31 December 2022. Our
independent auditor has confirmed that its audit procedures are
substantially completed and have not revealed any material
corrections required to be made to the financial information
included in this press release. Should any material changes arise
during the audit’s finalization, an additional press release will
be issued. We aim to publish the fully audited annual report for
the full year 2022 on, or around, 23 March 2023.
Conference call and webcast
presentationWe will host a conference call and webcast
presentation tomorrow 24 February 2023, at 14:00 CET / 8 AM ET. To
participate in the conference call, please register in advance
using this link. Upon registration, the dial-in numbers will be
provided. The conference call can be accessed 10 minutes prior to
the start time by using the conference access information provided
in the e-mail received at the point of registering, 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
Date |
Details |
23 March 2023 |
Publication Annual Report 2022 and 20-F 2022 |
25 April 2023 |
Annual Shareholders’ meeting |
4 May 2023 |
First quarter 2023 results (webcast 5 May 2023) |
3 August 2023 |
Half Year 2023 results (webcast 4 August 2023) |
2 November 2023 |
Third quarter 2023 results (webcast 3 November 2023) |
22 February 2024 |
Full year 2023 results (webcast 23 February 2024) |
About Galapagos Galapagos is a
fully integrated biotechnology company focused on discovering,
developing, and commercializing innovative medicines. We are
committed to improving patients’ lives worldwide by targeting
diseases with high unmet needs. Our R&D capabilities cover
multiple drug modalities, including small molecules and cell
therapies. Our portfolio comprises discovery through to
commercialized programs in immunology, oncology, and other
indications. Our first medicine for rheumatoid arthritis and
ulcerative colitis is available in Europe and Japan. For additional
information, please visit www.glpg.com or follow us
on LinkedIn or Twitter.
Jyseleca® is a trademark of Galapagos NV and
Gilead Sciences, Inc. or its related companies. Except
for filgotinib’s approval as Jyseleca® for the treatment of
moderate to severe RA and UC by the relevant regulatory authorities
in the European Union, Great Britain, and Japan, our drug
candidates are investigational; their efficacy and safety have not
been fully evaluated by any regulatory authority.
Contacts |
|
|
|
Media
relations |
Investor
relations |
Marieke
Vermeersch |
Sofie Van
Gijsel |
+32 479
490 603 |
+1 781 296
1143 |
|
|
Elisa
Chenailler |
Sandra
Cauwenberghs |
+41 79 853 33
54 |
+32 495 58 46
63 |
|
ir@glpg.com |
Hélène de
Kruijs |
|
+31 6
22463921 |
|
media@glpg.com |
|
Forward-looking statementsThis
press release contains 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 “believe,” “anticipate,” “expect,” “intend,” “plan,”
“seek,” “upcoming,” “future,” “estimate,” “may,” “will,” “could,”
“would,” “potential,” “forward,” “goal,” “next,” “continue,”
“should,” “encouraging,” “aim,” “progress,” “remain,’ “explore,”
“further” as well as similar expressions. These statements include,
but are not limited to, statements made in the sections captioned
“2022 operational review and post-period events” and “Outlook
2023”, the guidance from management regarding our financial results
(including guidance regarding the expected operational use of cash
and estimated peak sales for Jyseleca® during the financial year
2023), statements regarding the acquisitions of CellPoint and
AboundBio, including statements regarding anticipated benefits of
the acquisitions and the integration of CellPoint and AboundBio
into our portfolio and strategic plans, statements regarding our
regulatory outlook, statements regarding the amount and timing of
potential future milestones, and other payments , statements
regarding our R&D plans, strategy and outlook, including
progress on our immunology or oncology portfolio, CAR-T-portfolio
and our SIKi portfolio, and potential changes in such strategy,
statements regarding our pipeline and complementary technology
platforms facilitating future growth, 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 regarding the global
R&D collaboration with Gilead and the amendment of our
arrangement with Gilead for the commercialization and development
of filgotinib, statements regarding the expected timing, design and
readouts of our 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) GLPG2737 in autosomal dominant polycystic kidney
disease (ADPKD), (iv) GLPG5101 in rrNHL and rSLE, (v) GLPG5201 in
rrCLL and rrSLL, and (vi) GLPG5301 in rrMM, including recruitment
for trials and topline results for trials and studies in our
portfolio, statements relating to interactions with regulatory
authorities, 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
under Article 20 of Regulation (EC) No 726/2004 and regarding the
related CHMP opinion, statements regarding the CHMP opinion for
filgotinib, statements about the European label update based on
testicular function safety data from MANTA/RAy studies, statements
relating to the timing or likelihood of additional regulatory
authorities’ approval of marketing authorization for filgotinib for
RA, UC or any other indication, statements regarding the changes in
our leadership and expected resulting benefits, the timing or
likelihood of pricing and reimbursement interactions for
filgotinib, statements relating to the development of our
commercial organization, statements and expectations regarding the
rollout of our products or product candicates (if approved) in
Europe, statements related to the expected reimbursements for
Jyseleca®, statements regarding patient enrollment for the Phase 2
programs with our TYK2 inhibitor product candidate, GLPG3667, and
the timing for the start of a study in SLE, statements regarding
the timing of clinical development with our CD19 CAR-T candidate,
GLPG5101, in rSLE, statements regarding the progress of patient
recruitment efforts in the European sites of the Phase 1/2
ATALANTA-1 study with our CD19 CAR-T candidate, GLPG5101, in rrNHL
as well as in the EUPLAGIA-1 study with our CD19 CAR-T candidate,
GLPG5201, in rrCLL/SLL, and the timing for Phase 1 topline results
from such studies, statements regarding the timing for expansion
of, and patient enrollment in, the CAR-T portfolio with a BCMA
CAR-T product candidate, GLPG5301, in refractory/relapsed multiple
myeloma (rrMM), and portfolio goals, business plans, and
sustainability plans. Galapagos cautions the reader that
forward-looking statements are based on our management’s current
expectations and beliefs and are not guarantees of future
performance. Forward-looking statements may involve known and
unknown risks, uncertainties and other factors which might cause
actual events, financial condition and liquidity, performance or
achievements, or the industry in which we operate, to be materially
different from any historic or future results, financial
conditions, performance or achievements expressed or implied by
such forward-looking statements. In addition, even if Galapagos’
results, performance, financial condition and liquidity, and the
development of the industry in which it operates are consistent
with such forward-looking statements, they may not be predictive of
results or developments in future periods. Such risks include, but
are not limited to, the risk that our expectations and management’s
guidance regarding our 2023 revenues, operating expenses, cash burn
and other financial results may be incorrect (including because one
or more of its assumptions underlying our revenue or 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
Galapagos’ ongoing and planned clinical research programs in
rheumatoid arthritis, ulcerative colitis, dermatomyositis, systemic
lupus erythematosus, axial spondyloarthritis, autosomal dominant
polycystic kidney disease, refractory/relapsed Non-Hodgkin
lymphoma, refractory/replapsed chronic lymphocytic leukemia,
refractory/replapsed small lymphocytic lymphoma,
refractory/relapsed Multiple Myeloma and other immunologic
indications or any other indications or diseases, may not support
registration or further development of its 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, the inherent risks and
uncertainties associated with target discovery and validation and
drug discovery and development activities, risks related to our
reliance on collaborations with third parties (including, but not
limited to, our collaboration partner Gilead), the risks related to
the timing and implementation of the transition of the European
commercialization responsibility of filgotinib from Gilead to us,
including the transfer of the supply chain, the risk that the
transition will not have the currently expected results for our
business and results of operations 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, including the risk that
our plans with respect to CAR-T may not be achieved on the
currently anticipated timeline or at all, the risk that our
projections and expectations regarding the commercial potential of
our product candidates or expectations regarding the costs and
revenues associated with the commercialization rights may be
inaccurate, the risks related to our strategic transformation
exercise, 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 disruption in our operations, supply chain
or ongoing studies due to the conflict between Russia and Ukraine,
risks related to continued regulatory review of filgotinib
following approval by relevant regulatory authorities and the EMA’s
safety review of JAK inhibitors used to treat certain inflammatory
disorders, the risk that the EMA may impose JAK class-based
warnings, and the risk that the EMA’s planned 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 related to the impact of
the COVID-19 pandemic. A further list and description 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 our subsequent filings and reports filed 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 the result of our operations, financial condition
and liquidity, or the industry in which we operate, are consistent
with such forward-looking statements, they may not be predictive of
results, performance or achievements 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 to reflect any
change in our expectations with regard thereto or any change in
events, conditions or circumstances on which any such statement is
based or that may affect the likelihood that actual results will
differ from those set forth in the forward-looking statements,
unless specifically required by law or regulation.
1 Annual Society of Hematology2 European
Society for Blood and Marrow Transplantation (EBMT)-European
Hematology Association (EHA)
i Throughout this press release, ‘Dr. Paul
Stoffels’ should be read as ‘Dr. Paul Stoffels, acting via Stoffels
IMC BV’ii 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,
related to the 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 year 2022 amounted to €513.8 million and can be
reconciled to our cash flow statement by considering the decrease
in cash and cash equivalents of €1,747.5 million, adjusted by (i)
the cash proceeds from capital and share premium increase from the
exercise of subscription rights by employees for €6.7 million, (ii)
the net purchase of current financial investments amounting to
€1,087.0 million, and (iii) the cash out from acquisition of
subsidiaries, net of cash acquired, of €153.4 millioniii General
and administrativeiv Sales and marketing
- fy22_financial_tables_en
- Galapagos announces full year 2022 results and outlook for
2023
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