- 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
Webcastreplay available atwww.glpg.com
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
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
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) (
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
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
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 Phase 4 programs in immunology, oncology, and other indications. Our first medicine for rheumatoid arthritis and ulcerative colitis is available in the
Contact
Investors:
Head of Investor Relations
+1 781 296 1143
Director Investor Relations
+32 495 58 46 63
ir@glpg.com
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Head of Corporate Communication
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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
1 Cluster of differentiation 19
2 B-cell maturation antigen
3 Acting via
4 Poster presented at
Attachment
- Galapagos presents roadmap for pipeline and commercial growth at its R&D Day 2022
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