Galapagos refocuses pipeline and rightsizes operations
- First three
months 2021
financial results:
- Group revenues and other
income of
€124.2
million
- Operating loss of
€50.8
million
- Net profit of
€9.4
million
- Cash and current financial
investments of €5.1
billion on
31 March
2021
- Refocused clinical
pipeline by critically examining risk profile and
breadth
- Filgotinib launch in Europe on track
- Initiated €150 million
savings program
Webcast presentation
tomorrow,
07 May
2021, at
14.00 CET / 8 AM ET,
www.glpg.com,
+32 2 793 38 47,
code 5042688
Mechelen, Belgium;
06 May
2021,
22.01 CET; regulated
information – Galapagos NV (Euronext & NASDAQ:
GLPG) announces its unaudited
Q1 results and
operational highlights, which are further
detailed in the
Q1
2021 report
available on the Galapagos
website,
www.glpg.com.
“These last months, we completed a review of our
portfolio and development plans with the goal to select a more
risk-balanced pipeline. We decided to retain our focus on novel
targets to address unmet medical needs in inflammation, fibrosis,
and kidney diseases. We also remain fully committed to the launch
of Jyseleca in Europe. Moving forward with confidence, we decided
to:
- Refocus our clinical pipeline by critically examining its risk
profile and breadth;
- Cut significant cost in the organization to support this
re-sized pipeline development;
- Task our business development team to identify and execute on a
transformative opportunity.
We believe that our strong cash position, expert teams, and
solid scientific foundation position us well for future growth,”
said Onno van de Stolpe, CEO of Galapagos.
Refocused pipelineIn the
revision exercise, Galapagos set goals to focus and adjust the
overall risk profile of its clinical pipeline. Consequently, we
prioritized those assets with what we believe have enhanced chances
of clinical success in our core therapeutic areas. As such, we
announce:
- We are testing our lead Toledo program ‘3970, a SIK2/3
inhibitor, in five Proof of Concept studies in different
indications, and pending the outcome of the studies, we plan to
roll out our further development plans in the second half of the
year;
- We selected an additional molecule from our Toledo program,
SIK2/3 inhibitor '4876, as a candidate to accelerate from
preclinical phase into clinical development;
- We aim to progress our TYK2 inhibitor ‘3667 into Phase 2b;
- We selected chitinase inhibitor ’4617 to progress to Phase 2 in
IPF and decided to stop development of our other IPF molecule
’1205;
- We stopped further work on ‘4059 for metabolic disease, given
that this is not a core therapeutic area;
- We discontinued our early research efforts in metabolic
diseases and osteoarthritis; and
- We challenged and fine-tuned our stage-gating process to
advance compounds.
Commercial progress
We remain well on track in launching filgotinib
in Europe. In the first quarter, we successfully completed the
transitions of commercial and medical teams from Gilead in Germany,
the UK, Spain, and Italy. We believe everything is in place to
complete the final transitions from Gilead to us by year-end. Q1
also saw progress on access and reimbursement for filgotinib in
rheumatoid arthritis (RA). Gilead submitted the new drug
application in Japan for the treatment of ulcerative colitis (UC).
We are encouraged by the primary endpoint outcome with the
MANTA/RAy semen parameter studies as we await the Committee for
Medicinal Products for Human Use (CHMP) opinion in UC.
Bart Filius, President and COO, added, “In line
with our review, we decided to discontinue or cancel certain
studies and consequently identified opportunities to reduce
operational costs, for a total potential savings of €150M on a
full-year basis. Roughly half of these savings will be realized in
2021, resulting in a 2021 cash burni guidance of between €580
million and €620 million. We are working towards a right-sized,
refocused version of Galapagos, setting us on a path towards
success with our first commercial product, new R&D
opportunities, substantial clinical news flow, and a lengthened
cash runway for validation of our early pipeline assets.”
Key figures
first quarter
report
2021
(unaudited)(€ millions, except
basic & diluted
gain/loss (-)
per share)
|
31 March
2021
group
total |
31 March
2020
group
total (*) |
Revenues and other income |
124.2 |
103.6 |
R&D expenditure |
(130.0) |
(115.5) |
G&Aii and S&Miii expenses |
(45.0) |
(34.3) |
Operating
loss |
(50.8) |
(46.2) |
Fair value re-measurement of financial instruments |
2.0 |
(20.5) |
Net other financial result |
36.2 |
14.8 |
Income taxes |
(0.2) |
(0.3) |
Net loss from continuing operations |
(12.8) |
(52.3) |
Net profit from discontinued operations |
22.2 |
1.7 |
Net profit/loss (-)
of the period |
9.4 |
(50.6) |
Basic gain/loss (-) per share (€) |
0.14 |
(0.78) |
Diluted gain/loss (-) per share (€) |
0.14 |
(0.78) |
Current financial investments and cash and
cash equivalents |
5,114.7 |
5,722.4 |
(*) The 2020 comparatives have been restated to
consider the impact of classifying the Fidelta business as
discontinued operations in 2020.
Details of the financial
resultsDue to the sale of our fee-for-service business
(Fidelta) to Selvita on 4 January 2021 for a total consideration of
€37.1 million (including customary adjustments for net cash and
working capital), the results of Fidelta are presented as “Net
profit from discontinued operations” in our consolidated income
statements for the three months ended 31 March 2021 and 31 March
2020.
Revenues and other income
from continuing operationsOur revenues and other
income from continuing operations for the first three months of
2021 increased to €124.2 million compared to €103.6 million in the
first three months of 2020. Our revenues from the Gilead
collaboration in the first three months of 2021 (€113.7 million)
related to (i) the exclusive access to our drug discovery platform
(€57.8 million), (ii) the filgotinib revenue recognition (€55.3
million) and (iii) royalties (€0.7 million).
Our deferred income balance on 31 March 2021
includes €1.9 billion allocated to our drug discovery platform that
is recognized linearly over 10 years, and €0.8 billion allocated
for the filgotinib development (including considerations for the
previous and the renegotiated collaboration combined) that is
recognized over time until the end of the development period.
Results from continuing
operationsWe realized a net loss from continuing
operations of €12.8 million for the first three months of
2021, compared to a net loss of €52.3 million for the first
three months of 2020.
We reported an operating loss amounting to
€50.8 million for the first three months of 2021, compared to
an operating loss of €46.2 million for the same period last
year.
Our R&D expenditure in the first three
months of 2021 amounted to €130.0 million, compared to
€115.5 million for the first three months of 2020. This
increase was due to an increase in subcontracting costs primarily
related to our filgotinib program, our Toledo program and other
clinical programs, compensated by a decrease for ziritaxestat, the
OA program with GLPG1972 and the program in atopic dermatitis (AtD)
with MOR106. Furthermore, the increase in personnel costs is
explained by a planned headcount increase following the growth in
our activities, and increased cost of the subscription right plans.
This factor, and the increased cost of the commercial launch of
filgotinib in Europe, contributed to the increase in our S&M
and G&A expenses, which were respectively €14.6 million and
€30.4 million in the first three months of 2021, compared to
respectively €9.8 million and €24.5 million in the first three
months of 2020.
We reported a non-cash fair value gain from the
re-measurement of initial warrant B issued to Gilead, amounting to
€2.0 million, mainly due to the decreased implied volatility of the
Galapagos share price and its evolution between 31 December 2020
and 31 March 2021.
Net other financial income in the first three
months of 2021 amounted to €36.2 million, compared to net
other financial income of €14.8 million for the first three
months of 2020, which was primarily attributable to €45.5 million
of currency exchange gain on our cash and cash equivalents and
current financial investments in U.S. dollars, and to €6.5 million
of negative changes in (fair) value of current financial
investments and financial assets.
Results from discontinued
operationsThe net profit from discontinued operations for
the three months ended 31March 2021 consisted of the gain on the
sale of Fidelta, our fee-for-services business, for €22.2
million.
Group net
resultsWe reported a group net profit for the
first three months of 2021 of €9.4 million, compared to a group net
loss of €50.6 million for the first three months of 2020.
Cash
positionCurrent financial investments and cash and
cash equivalents totaled €5,114.7 million on 31 March 2021, as
compared to €5,169.3 million on 31 December 2020.
Total net decrease in cash and cash equivalents
and current financial investments amounted to €54.6 million during
the first three months of 2021, compared to a net decrease of €58.4
million during the first three months of 2020. This net decrease
was composed of (i) €127.7 million of operational cash burn, (ii)
offset by €2.3 million of cash proceeds from capital and share
premium increase from exercise of subscription rights in the first
three months of 2021, (iii) €3.6 million negative changes in (fair)
value of current financial investments and €45.7 million of mainly
positive exchange rate differences, (iv) €28.7 million cash in from
disposal of subsidiaries, net of cash disposed.
Finally, our balance sheet on 31 March 2021 held
a receivable from the French government (Crédit d’Impôt
Rechercheiv) and a receivable from the Belgian Government for
R&D incentives, for a total of both receivables of €142.3
million.
Outlook 2021We
anticipate several regulatory announcements on filgotinib as well
as progress in our differentiated pipeline of novel target-based
candidates.
We expect reimbursement decisions in most key
European markets for filgotinib in RA this year, as we complete the
transition to a full European commercial operation by year end. We
anticipate a CHMP opinion and a European Commission decision for
filgotinib in UC. We expect that our collaboration partner Gilead
will complete recruitment for the global DIVERSITY Phase 3 trial in
Crohn’s disease this year.
Within our broader inflammation portfolio, we
expect to report topline results from several trials this year,
including a Phase 1b trial with TYK2 inhibitor ‘3667 in psoriasis,
and three Proof of Concept studies with lead Toledo candidate
SIK2/3 inhibitor ‘3970 in psoriasis, UC, and RA.
Within our fibrosis portfolio, we expect to
progress early clinical compounds with novel mechanisms of action,
with the aim to develop novel treatments to help patients suffering
from this debilitating condition.
Following the review of our plans for 2021, we
give guidance for full year 2021 operational cash burn of €580 to
€620 million.
First quarter
report
2021
Galapagos’ financial report for the first three
months ended 31 March 2021, including details of the unaudited
consolidated results, is accessible via
www.glpg.com/financial-reports.
Results of annual ordinary shareholders'
meeting
On 28 April 2021, Galapagos held its annual
ordinary shareholders’ meeting. All agenda items were approved,
including the re-appointments of Ms. Katrine Bosley and Dr. Raj
Parekh as members of the supervisory board, and approval of the
remuneration report. All documents relating to the shareholders’
meeting are posted on our website at
https://www.glpg.com/shareholders-meetings.
Conference call and webcast
presentation
Galapagos will conduct a conference call open to
the public tomorrow, 07 May 2021, at
14:00 CET / 8 AM ET, which will also be
webcasted. To participate in the conference call, please call one
of the following numbers ten minutes prior to commencement:
CODE:
5042688
Standard International: |
+44 (0) 2071 928338 |
USA: |
+1 646 741 3167 |
UK: |
+44 844 481 9752 |
Netherlands: |
+31 207 95 66 14 |
France: |
+33 1 70 70 0781 |
Belgium: |
+32 2 793 38 47 |
A question and answer session will follow the
presentation of the results. Go to www.glpg.com to access the live
audio webcast. The archived webcast will also be available for
replay shortly after the close of the call.
Financial
calendar
05 August
2021 |
Half year 2021
results |
(webcast 06 August
2021) |
04 November
2021 |
Third quarter
2021 results |
(webcast 05 November
2021) |
24 February
2022 |
Full year 2021
results |
(webcast 25 February
2022) |
About Galapagos
Galapagos NV discovers and develops small
molecule medicines with novel modes of action, several of which
show promising patient results and are currently in late-stage
development in multiple diseases. Our pipeline comprises discovery
through Phase 3 programs in inflammation, fibrosis and other
indications. Our ambition is to become a leading global
biopharmaceutical company focused on the discovery, development,
and commercialization of innovative medicines. More information at
www.glpg.com.
Except for filgotinib’s approval for the treatment of rheumatoid
arthritis by the European Commission and Japanese Ministry of
Health, Labour and Welfare, our drug candidates are
investigational; their efficacy and safety have not been fully
evaluated by any regulatory authority.
Jyseleca® is a trademark of Galapagos NV and Gilead Sciences,
Inc. or its related companies.
Contact
Investors:Elizabeth GoodwinVP Investor
Relations +1 781 460 1784
Sofie Van GijselSenior Director Investor Relations+32 485 19 14
15ir@glpg.com
Media:Carmen VroonenGlobal Head of
Communications & Public Affairs+32 473 824 874
Kyra ObolenskySenior Director Corporate
Communications+32 491 92 64 35communications@glpg.com
Forward-looking statements
This release may contain forward-looking
statements, including, among other things, statements regarding the
global R&D collaboration with Gilead, the amount and timing of
potential future milestones, opt-in and/or royalty payments by
Gilead, Galapagos’ strategic R&D ambitions, including progress
on our fibrosis portfolio, and potential changes of such ambitions,
the guidance from management (including guidance regarding the
expected operational use of cash during financial year 2021),
financial results, statements regarding the expected timing, design
and readouts of ongoing and planned clinical trials, including
recruitment for trials and topline results for our trials and
studies in our inflammation portfolio, statements regarding the
strategic re-evaluation, 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, including UC and IBD
indication for filgotinib in Europe, the UK, Japan, and the U.S.,
such additional regulatory authorities requiring additional
studies, the timing or likelihood of pricing and reimbursement
interactions for filgotinib, statements relating to the build-up of
our commercial organization and commercial sales for filgotinib,
including in Europe, the expected impact of COVID-19, and our
strategy, business plans and focus. Galapagos cautions the reader
that forward-looking statements are not guarantees of future
performance. Forward-looking statements involve known and unknown
risks, uncertainties and other factors which might cause the actual
results, financial condition and liquidity, performance or
achievements of Galapagos, or industry results, 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. 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. Among the factors that
may result in differences are that our expectations regarding our
2021 revenues and financial results and our 2021 operating expenses
may be incorrect (including because one or more of its assumptions
underlying its expense expectations may not be realized),
Galapagos’ expectations regarding its development programs may be
incorrect, the inherent uncertainties associated with competitive
developments, clinical trial and product development activities and
regulatory approval requirements (including the risk that data from
Galapagos’ ongoing and planned clinical research programs in
rheumatoid arthritis, Crohn’s disease, ulcerative colitis,
idiopathic pulmonary fibrosis, osteoarthritis, and other
inflammatory indications may not support registration or further
development of its product candidates due to safety, efficacy or
other reasons), Galapagos’ reliance on collaborations with third
parties (including our collaboration partner Gilead), the timing of
and the risks related to implementing the amendment of our
arrangement with Gilead for the commercialization and development
of filgotinib, estimating the commercial potential of our product
candidates and Galapagos’ expectations regarding the costs and
revenues associated with the transfer of European commercialization
rights to filgotinib may be incorrect, and the uncertainties
relating to the impact of the COVID-19 pandemic. A further list and
description of these risks, uncertainties and other risks can be
found in Galapagos’ Securities and Exchange Commission (SEC)
filings and reports, including in Galapagos’ 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 uncertainties,
the reader is advised not to place any undue reliance on such
forward-looking statements. These forward-looking statements speak
only as of the date of publication of this document. Galapagos
expressly disclaims any obligation to update any such
forward-looking statements in this document to reflect any change
in its 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.
i The operational cash burn (or operational cash flow if this
performance 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, included in the
net cash flows generated from/used in (-) investing
activities.
This alternative performance measure is in our
view an important metric for a biotech company in the development
stage. The operational cash burn for the three months ended 31
March 2021 amounted to €127.7 million and can be reconciled to our
cash flow statement by considering the increase in cash and cash
equivalents of €379.1 million, adjusted by (i) the cash proceeds
from capital and share premium increase from the exercise of
subscription rights by employees for €2.3 million, (ii) the net
sale of current financial investments amounting to €475.8 million,
and (iii) the cash in from sale of subsidiaries, net of cash
disposed of, of €28.7 million. ii General and
administrativeiii Sales and marketingiv Crédit d’Impôt Recherche
refers to an innovation incentive system underwritten by the French
government
- Galapagos refocuses pipeline and rightsizes operations
Grafico Azioni Galapagos (EU:GLPG)
Storico
Da Mar 2024 a Apr 2024
Grafico Azioni Galapagos (EU:GLPG)
Storico
Da Apr 2023 a Apr 2024