Key 2021 and post period
events:
- Appointment of Dr. Paul Stoffels1
as new CEO, effective 1 April 2022, following planned retirement of
CEO and co-founder Onno van de Stolpe
- Jyseleca sales booked by Galapagos
in Europe were €14.8 million out of a total in-market performance
of €25.7 million
- Jyseleca (filgotinib) approved for
ulcerative colitis (UC) in Europe and Great Britain, reimbursement
for rheumatoid arthritis (RA) secured in 14 countries
- Patient enrollment completed in the
DIVERSITY Phase 3 program with filgotinib in Crohn’s Disease
(CD)
- Discontinuation of development of
ziritaxestat, GLPG1690, in Phase 3 program in idiopathic pulmonary
fibrosis (IPF)
- First patient results with salt
inducible kinase (SIK) 2/3 inhibitor GLPG3970 support further work
on this novel pharmacology
- Activity observed with selective
tyrosine kinase (TYK) 2 inhibitor GLPG3667 in psoriasis (Pso) Phase
1b study
Financial results in
2021:
- Group net revenues of €484.8 million as compared to €478.1
million in 2020
- Operating loss of €165.6 million as compared to €178.6 million
in 2020
- Net loss of €103.2 million as compared to €305.4 million in
2020
- Cash and current financial investments of €4.7 billion on 31
December 2021
- Operational cash burni of €564.8 million, within the guided
range
Webcast presentation
tomorrow, 25
February 2022,
at 14.00
CET / 8 AM ET,
www.glpg.com, +32 2 793
38 47, code 5438549
Mechelen, Belgium; 24
February 2022, 22.01
CET; regulated information –
Galapagos NV
(Euronext & NASDAQ: GLPG) presents
financial results
2021,
reviews key events for
the company, and provides
outlook for 2022.
“2021 was a year of reflection, resulting in
refocused R&D activities and resized spend, as well as
commercial roll-out, with a major effort to launch Jyseleca
throughout Europe,” said Onno van de Stolpe, CEO of Galapagos. “We
made excellent progress with Jyseleca and successfully completed
the process of becoming Marketing Authorization Holder (MAH) in
Europe for our first medicine. Improving patients’ lives is at the
core of what we do, and completing our transition to a fully
integrated, independent European biopharma is a major achievement
to make that mission a reality for patients suffering from chronic
debilitating conditions.
We received approval by the European Commission
(EC), and most recently by the Medicines and Healthcare products
Regulatory Agency (MHRA) in Great Britain, for a second indication
for Jyseleca for patients suffering from UC, and we continue to
roll out Jyseleca in RA and UC throughout Europe. Furthermore,
following the completion of patient enrollment in the DIVERSITY
Phase 3 program with filgotinib in CD, we anticipate topline
results in the first half of 2023.
Also for filgotinib, we were pleased to report
on the primary endpoint with the MANTA and MANTA-RAy studies
investigating the effect on semen parameters, indicating that 8.3%
patients on placebo and 6.7% patients on filgotinib had a 50% or
more decline in sperm concentration at week 13.
In 2021, we also made important progress across
our broader inflammation pipeline, most notably with our TYK2 and
SIKi programs. We observed clinical activity with our TYK2
inhibitor GLPG3667 in a Phase 1b study in Pso, and we are currently
finalizing a Phase 1 dose escalation study in healthy volunteers.
We reported results from the first patient studies of our SIKi
program with SIK2/3 inhibitor GLPG3970. The biological activity
observed in the studies in Pso and UC highlights the pioneering
role we are playing to unravel the role of SIKi in inflammation,
and support further development of our SIKi portfolio. We are
currently working on a set of follow-up SIKi compounds with
improved pharmacology and selectivity profiles, and plan to select
a preclinical candidate to move into a healthy volunteer study this
year.
Beyond inflammation, we discontinued further
development of ziritaxestat (GLPG1690) in IPF due to the
unfavorable risk/benefit profile observed by an Independent Data
Monitoring Committee (IDMC) in the Phase 3 trials. This not only
was a major setback for Galapagos but most importantly for patients
suffering from this debilitating disease for which current
treatment options remain limited.
Finally, we completed the patient recruitment in
our MANGROVE Phase 2 trial with our novel CFTR2 inhibitor GLPG2737
in patients with ADPKD3, with results expected in the first half of
2023.
I am very proud of our committed teams for
working tirelessly to bring novel mode of action medicines to
patients, and now that my tenure at the helm of this company
is drawing to an end, I could not be more honored to hand over the
baton to Paul. As a co-founder and board member in the early years,
Paul has a keen understanding of our roots as well as who we are
today. I strongly believe that Paul’s strategic
and inspirational leadership, along with his deep knowledge of
both the industry and Galapagos, make him the right next CEO to
deliver tremendous value to all stakeholders.”
Bart Filius, President, COO and CFO of
Galapagos, added: “We ended 2021 with a very strong balance sheet,
providing us with the foundations for future growth. One year after
receiving approval for Jyseleca in RA in Europe and Great Britain,
we secured reimbursement in 14 countries, covering the major
markets of Germany, France, Spain, Italy, and Great Britain. We
reported €14.8 million of Jyseleca sales in Europe out of a total
in-market performance of €25.7 million.
Following a strategic operational review in
March 2021, we implemented a cost savings program of €150 million
on a full year basis, which will take full effect in the course of
2022. Our operational cash burni in 2021 was €564.8 million,
within our reduced guidance. For 2022 we anticipate a further
significant reduction of our cash burn and expect to land between
€450 and €490 million. This includes sales for Jyseleca that we
anticipate between €65 and €75 million.”
Key figures
2021
(consolidated)(€
millions, except basic & diluted
loss per share)
|
31
December
2021
group
total |
31
December
2020
group
total |
Product net salesCollaboration revenuesTotal
net revenues |
14.8470.1484.8 |
-478.1478.1 |
Cost of salesR&D expenditure |
(1.6)(491.7) |
-(523.7) |
G&Aii and S&Miii expensesOther operating income |
(210.9)53.7 |
(185.2)52.2 |
Operating
loss |
(165.6) |
(178.6) |
Fair value re-measurement of financial instruments |
3.0 |
3.0 |
Net other financial result |
39.6 |
(134.2) |
Income taxes |
(2.4) |
(1.2) |
Net loss from continuing operations |
(125.4) |
(311.0) |
Net profit from discontinued operations |
22.2 |
5.6 |
Net loss of
the period |
(103.2) |
(305.4) |
Basic and diluted loss per share (€) |
(1.58) |
(4.69) |
|
|
|
Current financial investments and cash and
cash equivalents |
4,703.2 |
5,169.3 |
Details of the financial
resultsAfter the sale of our fee-for-service business
(Fidelta) to Selvita on 4 January 2021, we only have one remaining
reporting segment. The results of Fidelta, including the impact of
the 2021 sale, are presented as “Net profit from discontinued
operations” in our consolidated income statements for the years
2021 and 2020.
Revenues from
continuing operationsOur net revenues from continuing
operations in 2021 amounted to €484.8 million compared to €478.1
million in 2020.
We reported net sales of Jyseleca in 2021
amounting to €14.8 million, which reflects the sales booked by
Galapagos after the country-by-country transition from Gilead.
Collaboration revenues amounted to €470.1
million in 2021, compared to €478.1 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 €235.7 million in 2021
(€228.1 million in 2020). The revenue recognition related to
the exclusive access rights for Gilead to our drug discovery
platform amounted to €230.6 million in 2021 (€229.6 million last
year). Additionally we have recognized royalty income from Gilead
for Jyseleca for €3.8 million in 2021 (compared to €16.2 million in
2020, which was mainly from income related to upfront payments from
a distribution agreement for the commercial launch of filgotinib in
Japan).
Our deferred income balance at 31 December 2021
includes €1.8 billion allocated to our drug discovery platform that
is recognized linearly over 10 years, and €0.6 billion allocated to
the filgotinib development that is recognized over time until the
end of the development period.
Results from continuing
operations
We realized a net loss from continuing
operations of €125.4 million in 2021, compared to a net loss
of €311.0 million in 2020.
We reported an operating loss amounting to
€165.6 million in 2021, compared to an operating loss of
€178.6 million in 2020.
Cost of sales related to Jyseleca net sales in 2021 amounted to
€1.6 million.
Our R&D expenditure in 2021 amounted to
€491.7 million, compared to €523.7 million in 2020. This
decrease was primarily due to the winding down of the programs with
ziritaxestat (IPF), MOR106 (atopic dermatitis), and GLPG1972 (OA),
and reduced spend on our other programs. This was partly offset by
cost increases for our filgotinib and Toledo (SIKi) programs, on a
yearly comparison basis.
Our S&M and G&A expenses
were respectively €70.0 million
and €140.9 million in 2021, compared
to respectively €66.5 million and
€118.8 million in 2020. This increase was primarily
due to an increase in personnel costs resulting from an increase in
headcount and other operating expenses mainly driven by the
commercial launch of filgotinib in Europe. This increase was partly
offset by higher cost recharges from us to Gilead in the scope of
our commercial cost sharing for filgotinib in Europe.
Other operating income (€53.7 million in
2021 vs €52.2 million last year) slightly increased, mainly
driven by higher grant income.
We reported a non-cash fair value gain from the
re-measurement of initial warrant B issued to Gilead, amounting to
€3.0 million in 2021 (€3.0 million in 2020), mainly due to the
decreased implied volatility of the Galapagos share price and its
evolution between 31 December 2020 and 31 December 2021.
Net other financial income in 2021 amounted to
€39.6 million, compared to net other financial loss of
€134.2 million in 2020. Net other financial income in 2021 was
primarily attributable to €57.2 million of currency exchange gains
on our cash and cash equivalents in U.S. dollars, and to €8.8
million of net interest expenses. The other financial expenses also
contained the effect of discounting our long term deferred income
of €9.3 million.
Results from discontinued
operationsThe net profit from discontinued
operations in 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 loss in 2021 of
€103.2 million, compared to a group net loss of €305.4 million in
2020.
Cash
positionCurrent financial investments and cash and
cash equivalents totaled €4,703.2 million on 31 December 2021, as
compared to €5,169.3 million on 31 December 2020 (including the
cash and cash equivalents included in the assets as classified as
held for sale).
Total net decrease in cash and cash equivalents
and current financial investments amounted to €466.1 million in
2021, compared to a net decrease of €611.5 million in 2020. This
net decrease was composed of (i) €564.8 million of operational cash
burn, offset by (ii) €6.8 million positive changes in (fair) value
of current financial investments and €59.9 million of mainly
positive exchange rate differences, (iii) €3.3 million of cash
proceeds from capital and share premium increase from exercise of
subscription rights in 2021, and (iv) €28.7 million cash in from
disposal of subsidiaries.
Our balance sheet on 31 December 2021 included
R&D incentives receivables from the French government (Crédit
d’Impôt Rechercheiv) and from the Belgian government, for a total
of €144.0 million.
Outlook 2022
Early in 2022, we announced the appointment of
Dr. Paul Stoffels as successor to our co-founder and current CEO
Onno van de Stolpe, effective 1 April 2022. Paul is widely
recognized as an inspirational industry leader with exceptional
R&D and global executive experience, with an outstanding track
record of accelerated product development in biotech and
pharma through insightful acquisitions and strategic
partnerships.
In 2022, we expect reimbursement decisions in
most key European markets for Jyseleca in UC. In Japan,
collaboration partner Gilead expects a decision on the potential
approval for Jyseleca in UC in the first half of 2022, which
potentially could add a second indication for Jyseleca in this
market.
Early this year, the EMA announced that its
Pharmacovigilance Risk Assessment Committee (PRAC) started an
Article 20 specific pharmacovigilance procedure to investigate the
safety data for all JAK inhibitors following recent results from
the ORAL Surveillance study with tofacitinib4 as well as the data
from an observational study with baricitinib5. Following initiation
of this procedure, all JAKi MAHs will be invited to submit evidence
and we will continue to work with the EMA. The European Commission
has asked the EMA to give its opinion by 30 September 2022.
Within our broader inflammation portfolio, we
expect the read out from a Phase 1b trial with JAK1 inhibitor
GLPG0555 in osteoarthritis and from multiple Phase 1 trials in
healthy volunteers. We aim to progress our TYK2 inhibitor GLPG3667
into a Phase 2 program, following the dose escalation Phase 1 study
currently being finalized, also taking into account the current
regulatory and competitive landscape for TYK2 as a class. We aim to
advance selected compounds with optimized pharmacology and
selectivity from our SIKi portfolio into the clinic. Within our
fibrosis portfolio, we anticipate starting a Phase 2 trial with
chitinase inhibitor GLPG4716 in IPF.
For 2022 we anticipate a further significant
reduction of our cash burn and expect to land between €450 and €490
million. This includes sales for Jyseleca that we anticipate
between €65 and €75 million.
We believe our strong cash balance affords us
the opportunity to develop our pipeline through internal as well as
externally sourced assets. We expect our scientific expertise,
strong leadership, and growing commercial Jyseleca franchise to
propel us forward as we rebuild a differentiated pipeline of novel
mode of action drug candidates to help patients in need of new
treatment options.
Annual report 2021
Galapagos is currently finalizing its financial
statements for the year ended 31 December 2021. Our independent
auditor has confirmed that its audit procedures, which are
substantially completed, 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
finalization, an additional press release will be issued. Galapagos
expects to be able to publish its fully audited annual report for
the full year 2021 on or around 24 March 2022.
Conference call and webcast
presentation
Galapagos will conduct a conference call open to
the public tomorrow, 25 February 2022, 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:
5438549
Standard International: |
+44 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
24 March 2022 |
Publication Annual Report 2021 and 20-F 2021 |
26 April 2022 |
Annual Shareholders’ meeting |
|
5 May 2022 |
First quarter 2022 results |
(webcast 6 May 2022) |
4 August 2022 |
Half Year 2022 results |
(webcast 5 August 2022) |
3 November 2022 |
Third quarter 2022 results |
(webcast 4 November 2022) |
23 February 2023 |
Full year 2022 results |
(webcast 24 February 2023) |
About Galapagos
Galapagos NV discovers, develops, and
commercializes small molecule medicines with novel modes of action.
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 (i) rheumatoid arthritis by the European Commission,
Great Britain’s Medicines and Healthcare products Regulatory Agency
and Japanese Ministry of Health, Labour and Welfare and (ii)
ulcerative colitis by the European Commission and Great Britain’s
Medicines and Healthcare products Regulatory Agency, 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.
ContactInvestors:Sofie
Van GijselHead of Investor Relations+1 781 296 1143
Sandra CauwenberghsDirector Investor Relations+32 495 58 46
63ir@glpg.com
Media:Marieke VermeerschHead of Corporate
Communication+32 479 490 603
communications@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’ R&D plans and strategy, including progress
on our fibrosis portfolio, oral therapeutics and SIK platform, and
potential changes in such ambitions, statements regarding
Galapagos’ commercialization efforts for filgotinib and any future
approved products, guidance from management regarding our financial
results (including guidance regarding the expected operational use
of cash during financial year 2022), statements regarding the
expected timing and design of our ongoing and planned preclinical
studies and clinical trials, including for (i) filgotinib in RA, UC
and CD, including the MANTA/MANTA-RAy trials, (ii) GLPG3667 in Pso
and UC, (iii) GLPG3970 in UC and Pso, (iv) GLPG2737 in ADPKD, (v)
GLPG0555 in OA and (vi) GLPG4716 in IPF, including expected timing
for subject recruitment and enrollment and timing of results,
statements relating to interactions with regulatory authorities,
statements related to the EMA’s planned 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, statements
relating to the timing or likelihood of additional regulatory
authorities’ approval of marketing authorization for filgotinib for
RA, UC or any other indication, including UC for filgotinib in
Japan, and the U.S. and IBD in Europe, Great Britain, Japan, and
the U.S., statements regarding planned changes in our leadership
and expected resulting benefits, the timing or likelihood of
pricing and reimbursement interactions for filgotinib, statements
relating to the build-up of our commercial organization, including
in Europe and Great Britain, and statements and expectations
regarding commercial sales for filgotinib and rollout in Europe.
Galapagos cautions the reader that forward-looking statements are
not guarantees of future performance. Forward-looking statements
are based on management’s current expectations and beliefs and are
subject to a number of risks, uncertainties and other important
factors that may cause actual events, financial condition and
liquidity, performance, or results to differ materially from any
historic or future results, financial conditions and liquidity,
performance or achievements expressed or implied by such
forward-looking statements. When used in this press release, the
words “anticipate”, “believe”, “could”, “expect”, “intend”, “will”,
“plan”, “potential”, “should”, and similar expressions are intented
to identify 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 one or more
assumptions, beliefs or expectations underlying management’s
guidance regarding our 2022 revenues, operating expenses and
financial results may be incorrect (including one or more of its
assumptions underlying its expense expectations), 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, other inflammatory indications and kidney disease
may not support registration or further development of its product
candidates due to safety or efficacy concerns or other reasons),
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, the risk that the transition will not
be completed on the currently contemplated timeline or at all,
including the transfer of the supply chain, the risk that the
transition will be more expensive to us than expected, the risk
that the transition will not have the currently expected results
for our business and results of operations, the risk that our
projections and expectations regarding the commercial potential of
filgotinib and any other product candidates may be inaccurate, the
risk that our planned leadership transition may be disruptive to
our business operations, the risk that we will be unable to
successfully achieve the anticipated benefits from our planned
leadership transition, the risk that we will encounter challenges
retaining or attracting talent; risks related to continued
regulatory review of filgotinib following approval by relevant
regulatory authorities and the EMA’s planned safety review of JAK
inhibitors used to treat certain inflammatory disorders, including
the risk that the EMA and/or other regulatory authorities determine
that additional non-clinical or clinical studies are required with
respect to filgotinib, the risk that the EMA may require that the
marketing authorization for filgotinib in the EU be amended, 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 risks related to
the ongoing COVID-19 pandemic. For a discussion of other risks and
uncertainties and other important factors any of which could cause
our actual results to differ from those contained in the
forward-looking statements, see the section entitled “Risk Factors”
in our most recent Annual Report on Form 20-F filed with the U.S.
Securities and Exchange Commission (SEC), as supplemented and/or
modified by any other filings and reports that we have made or will
make with the SEC in the future.
All information in this press release is as of
the date of the release, and Galapagos undertakes no duty to update
this information unless required by law or regulation.
1 Acting via Stoffels IMC BV2 Cystic
Fibrosis Transmembrane Conductance Regulator3 Autosomal Dominant
Polycystic Kidney Disease4 Xeljanz®, Pfizer5 Olumiant®, Eli
Lilly
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 in 2021 amounted to €564.8 million and can be
reconciled to our cash flow statement by considering the increase
in cash and cash equivalents of €33.5 million, adjusted by (i) the
cash proceeds from capital and share premium increase from the
exercise of subscription rights by employees for €3.3 million, (ii)
the net sale of current financial investments amounting to €566.4
million, and (iii) the cash in from sale of subsidiaries, net of
cash disposed, 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
- fy 21_financial_tables_EN final
- Galapagos 2021 results set stage for future growth
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