Galapagos presents roadmap for pipeline and commercial growth at
its R&D Day 2022
- Guiding principles for a sustainable
future:
- Invest in strategic
therapeutic areas of oncology
and immunology
- Rebuild and accelerate portfolio
of transformational
medicines in high unmet medical
needs
- Combine internal
with external innovation
- Capital allocation:
- Discontinue
fibrosis and kidney
disease to further
invest in oncology
- Leverage strong balance sheet through
disciplined cash management
and smart business
development
- Oncology roadmap:
- Validate point-of-care
CAR-T delivery model with
proven CD191 and
BCMA2
- Develop next-generation,
best-in-class oncology candidates
- Immunology roadmap:
- Evaluate
potential of
filgotinib in axial
spondyloarthritis
- Execute on
TYK2i clinical
program with ‘3667
- Continue to invest in deep portfolio across modes of
action, with
JAKi, TYK2i and
SIKi programs
- Commercial roadmap:
- Jyseleca®
2022 net sales
guidance further upped
to
€80-€90
million
- Leverage commercial infrastructure for future
launches
Webcast replay available
at www.glpg.com
Mechelen, Belgium;
4 November
2022,
21.01 CET;
Galapagos NV (Euronext & NASDAQ: GLPG)
today held its R&D
Day 2022, featuring
presentations of key opinion leaders and company management on the
strategic, scientific, and
commercial progress at the company. The company
also presented its financial results for the third quarter
of 2022.
Paul Stoffels3, CEO and Chairman of the Board of
Directors of Galapagos, commented: “Today we presented our
strategic vision for our future as a financially sustainable
biopharma company. Building on our strong fundamentals, we are
convinced that we are taking the right steps to deliver on our core
mission: adding years of life and improving the quality of life of
patients globally.
Focusing on our strategic therapeutic areas, we
strive to push forward our deep, differentiated portfolio in
immunology, build out our oncology franchise, and execute on
business development opportunities with the aim to accelerate
innovation and speed up time-to-patients, while creating long-term
value for our stakeholders.”
Strategic update
Building on our strong fundamentals, we aim to
build a financially sustainable biopharma company, accelerating
cutting-edge therapies to market to address unmet medical needs in
our core key therapeutic areas of oncology and immunology.
Our renewed focus on two strategic therapeutic
areas goes hand in hand with redirecting our resources. To further
streamline our portfolio, we have decided to discontinue activities
in fibrosis and kidney disease to allow for increased investments
in our oncology franchise. To shape our portfolio of innovative
drugs with accelerated time-to-market, we intend to combine
internal innovation with smart business development and apply deep
clinical expertise to push programs through an optimal development
process.
Based on these guiding principles, we presented
our Vision 2028 portfolio outlook. Over the course of the next five
years, we aim to build a portfolio comprising:
- over 10 assets in lead optimization
and five in preclinical development across different modalities
(small molecules, cell therapy, biologics),
- five pivotal-stage candidates
forming a solid late-stage pipeline in immunology and cell therapy,
and
- a growing commercial presence with
additional marketed indications for Jyseleca® and
one CAR-T therapy approved in multiple indications.
Financial vision
Aligned with our Vision 2028, we presented our
financial outlook and capital allocation strategy at our R&D
Day 2022. Discontinuation of our fibrosis and kidney efforts allows
for reinvesting in oncology.
With Jyseleca® potentially
breaking even in 2024, and projected peak sales of €500 million in
Europe and first oncology revenues potentially contributing to our
topline later this decade, we are committed to building a
sustainable financial future, with a significantly reduced cash
burn by 2028.
Oncology
We also presented our Vision 2028 roadmap for
oncology at our R&D Day 2022. Our core mission in the field is
to broaden patient access and improve clinical outcomes by bringing
best-in-class medicines to patients.
With the combined acquisitions of CellPoint and
AboundBio announced earlier this year, we positioned ourselves in
the cell therapy space, combining the potentially disruptive
manufacturing and delivery model of CellPoint (Lonza’s Cocoon®, a
closed, automated manufacturing platform for cell therapy) with the
ability to develop next-generation CAR-Ts, small molecules and
biologics.
Short term, our aim is to validate the
decentralized CAR-T delivery model with proven CAR-T therapies, and
we announced the addition of a BCMA Phase 1/2 trial on the Cocoon®
platform. This complements the currently ongoing CD19 Phase1/2
programs in recurring/refractory Non-Hodgkin Lymphoma (rrNHL;
ATALANTA study) and recurring/refractory Chronic Lymphocytic
Leukemia (rrCLL; EUPLAGIA study).
In the coming years, we intend to build a
pipeline of best-in-class cell therapies for hematologic
malignancies and leverage our capabilities to rapidly address unmet
needs in oncology.
Today, we showcased the robust process
performance of the Cocoon® system as well as first encouraging
biomarker patient data of the CAR-T expansion profile with a 7
day-point-of-care vein-to-vein treatment. Topline Phase 1 results
of both the rrNHL and rrCLL study are expected in the first half of
2023, followed by initial data of the BCMA study later in the
year.
Next year, we also aim to broaden the studies to
include U.S. patients, and we plan to submit Investigational New
Drug (IND) applications for both the CD19 and BCMA CAR-T programs
with the FDA.
Immunology
We have built up over 20 years of expertise in
immunology, resulting in a deep and growing pipeline with multiple
modes-of-action candidate medicines across all phases of
development, from preclinical to Phase 4.
We are excited about our selective TYK2
inhibitor, ‘3667, for which we presented new data elucidating its
potentially differentiating selectivity and potency profile. Ex
vivo and in vivo data show that ‘3667 fully blocks the INFa pathway
with once-daily dosing, while in our assays JAK2 and JAK1/3
dependent pathways are not affected. Further, no effects on
hematological parameters, lipids and creatine phosphokinase (CPK)
were observed, suggesting that ‘3667 does not show JAKi
‘fingerprints’ at therapeutic doses. Also based on the positive
results in psoriasis patients, we presented our development plan
for ‘3667, confirming the start of a Phase 2 study in
dermatomyositis (GALARISSO) around year-end and the intention to
start a Phase 2 study in systemic lupus erythematosus (SLE) in
2023.
We also presented an update on our SIKi
portfolio, a potential novel mode-of-action in immunology. With
targeted investments, we continue to make important progress in
developing next-generation best-in-class candidates that reach
optimal target coverage, teasing apart selectivity profiles that
indicate the potential of SIK3i for rheumatological indications and
SIK2/3i for inflammatory bowel disease. Our most advanced
candidate, SIK3 inhibitor ‘4399, has shown strong preclinical
evidence for potential in rheumatoid arthritis (RA) (EULAR 20224),
with a promising pharmacological and safety profile. We are
planning to start a proof-of-mechanism study in RA patients with
‘4399 mid 2023.
For filgotinib, our selective JAK1 inhibitor, we
are completing a Phase 3 program in Crohn’s disease (CD), with
results expected in the first half of 2023. Given the sales
momentum and supportive long-term safety and efficacy data
generated for filgotinib, we are currently exploring additional
indications for filgotinib, and plan to start a Phase 3 study in
axial spondyloarthritis (AxSpA) in 2023.
Commercial progress
Since becoming European marketing authorization
holder (MAH) of Jyseleca®, we successfully set up
our own commercial capabilities and are currently operational
throughout Europe in the current approved indications RA and
ulcerative colitis (UC). The financial results for the third
quarter of 2022 show continued strong sales momentum for
Jyseleca®, and we further raise our net sales
guidance 2022 from €75-€85 million at H1 2022 to €80-€90
million.
In the future, we aim to leverage our European commercial
infrastructure beyond Jyseleca®, in line with our
Vision 2028, to have at least one CAR-T cell therapy on the market
within five years.
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 moderately to severely 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.
About GalapagosGalapagos 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 Phase 4
programs in immunology, oncology, and other indications. Our first
medicine for rheumatoid arthritis and ulcerative colitis is
available in the European Union, Norway, Great Britain, and Japan.
For additional information, please visit www.glpg.com or follow us
on LinkedIn or Twitter.
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 603media@glpg.com
Forward-looking statements
This 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,” “expect,” “intend,”
“plan,” “future,” “estimate,” “may,” “potential,” “forward,”
“next,” “continue,” “promise” “encouraging,” “aim,” “explore,”
“further” as well as similar expressions. These statements include,
but are not limited to, statements made in the sections captioned
“strategic update,” “financial vision,” “commercial progress,”, the
guidance from management (including the guidance regarding the
expected operational use of cash during the 2022 fiscal year, the
expected financial results and our strategic and capital allocation
priorities), 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 and R&D outlook, statements regarding our expected
financial results, statements regarding the amount and timing of
potential future milestones, opt-in and/or royalty payments, our
R&D strategy, including progress on our immunology or oncology
portfolio or our JAKi, TYK2i and SIKi programs, and potential
changes in such strategy, statements regarding our pipeline and
complementary technology platforms driving future growth,
statements regarding our expectations on commercial sales of
filgotinib, 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 ongoing and
planned clinical trials, including topline results for trials and
studies in our portfolio, statements about the expected topline
results from the DIVERSITY Phase 3 study in CD, 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 other
indications for filgotinib in Europe, Great Britain, 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, commercial sales for filgotinib and
rollout in Europe, statements related to the expected reimbursement
for Jyseleca®, and statements regarding our
strategy (including our strategic transformation exercise),
portfolio goals, business plans, focus, and plans for a sustainable
future. We caution 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 our actual results, 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. Such risks
include, but are not limited to, the risk that our expectations
regarding our 2022 revenues and financial results or our 2022
operating expenses may be incorrect (including because one or more
of our 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 development, clinical trial, recruitment of patients
for trials and product development activities and regulatory
approval requirements (including, but not limited to, the risk that
data from our ongoing and planned clinical research programs in RA,
rrNHL, rrCLL, CD, UC, axial spondyloarthritis, dermatomyositis,
systemic lupus erythematosus, other immunologic indications or
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, 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 our collaboration
partner for filgotinib, Gilead), risks related to the
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 transition of the supply chain,
and the risk that the transition will not have the currently
expected results for our business and results of operations,
estimating the commercial potential of our product candidates and
our expectations regarding the costs and revenues associated with
the transfer of the European commercialization rights to filgotinib
may be incorrect, 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
encounter challenges retaining or attracting talent, risks related
to disruption in our operations, supply chain or ongoing studies
(including our DIVERSITY 1 study) due to the conflict between
Russia and Ukraine, the risks related to continued regulatory
review of filgotinib following approval by relevant regulatory
authorities and the European Medicines Agency’s (EMA) 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 market authorization for filgotinib in the EU be
amended, the risk that the EMA may impose JAK class-based warnings,
the risk that the EMA’s safety review may negatively impact
acceptance of filgotinib by patients, the medical community, and
healthcare payors 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 Cluster of differentiation 192 B-cell
maturation antigen3 Acting via Stoffels IMC BV4 Poster presented at
EULAR (European Alliance of Associations for Rheumatology) 2022,
POS0442
- Galapagos presents roadmap for pipeline and commercial growth
at its R&D Day 2022
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