Full year 2023 key financials:
- Group net revenues of €783.5 million, including Jyseleca® net sales of €112.3 million
- Cash and current financial investments of €3.7 billion on 31 December 2023
- Operational cash burni of €414.8 million, within guidance
2023 and year-to-date key updates:
- Transferred Jyseleca® business, including approximately 400 positions, to Alfasigma S.p.A.
- Achieved encouraging data from ongoing Phase 1/2 studies with CD19 CAR-T product candidates, GLPG5101 in rrNHL and GLPG5201, in rrCLL, with or without RT
- Expanded CAR-T pipeline with start of Phase 1/2 study with BCMA CAR-T product candidate GLPG5301 in rrMM
- Enrolled first patients in Phase 2 study with TYK2 inhibitor, GLPG3667, in DM and SLE
- For strategic reasons, it was decided not to continue development of CD19 CAR-T candidate in rSLE
- Expanded point-of-care CAR-T network in the U.S. with manufacturing agreements with Landmark Bio and Thermo Fisher Scientific
- Signed strategic research and license collaboration with BridGene Biosciences in precision oncology
- Participated in Series C financing round of US-based precision oncology company, Frontier Medicines
- Appointed Thad Huston as CFO and COO, and Dr. Susanne Schaffert and Mr. Simon Sturge as Non-Executive Independent Directors
Webcast presentation tomorrow, 23 February 2024, at 14:00 CET / 8:00 am ET, www.glpg.com
Mechelen, Belgium; 22 February 2024, 22:01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) reports full year 2023 results and provides outlook for 2024.
"In 2023, we took significant steps to reposition our organization, renew our focus on value creation, and advance our efforts to bring transformational medicines to patients around the world," said Dr. Paul Stoffels1, CEO and Chairman of the Board of Directors of Galapagos. "Following the successful transfer of the Jyseleca® business last month, we are moving forward with a streamlined portfolio and enhanced focus on our differentiated and innovative pipeline. We are determined to generate sustainable, long-term value for our shareholders, our patients, and our employees."
Dr. Stoffels continued, "We recently presented promising new data from our ongoing CD19 CAR-T programs and started the Phase 1/2 multiple myeloma BCMA CAR-T study, marking another milestone in the build-up of our oncology CAR-T portfolio. In addition, we entered into a strategic collaboration with BridGene Biosciences to advance our growing early-stage pipeline in precision oncology. As we look to the year ahead, we strive to make important progress in advancing our clinical programs, while further expanding our early-stage pipeline of small molecule programs."
Thad Huston, CFO and COO of Galapagos, concluded, "We ended 2023 with a strong financial position of €3.7 billion in cash and current financial investments. We will continue to execute on business development opportunities and invest in our pipeline to drive value for all our stakeholders."
Corporate and Operational Performance 2023
Oncology portfolio
- GLPG5201 (CD19 CAR-T) in relapsed/refractory chronic lymphocytic leukemia (rrCLL) and Richter transformation (RT) (cut-off date: 6 September 2023)
- Patient recruitment of the Phase 1 dose-finding part of EUPLAGIA-1 has been completed: 15 patients were enrolled (6 at dose level 1 (DL1); and 9 at dose level 2 (DL2)), all of whom were diagnosed with rrCLL and 9 with additional RT.
- Presented encouraging preliminary Phase 1 data at the ASH Annual Meeting, which demonstrated clinically meaningful results in severely compromised patient populations and highlighted the potential of Galapagos' point-of-care CAR-T manufacturing platform to deliver a fresh product with a median vein-to-vein time of only seven days.
- GLPG5101 (CD19 CAR-T) in relapsed/refractory non-Hodgkin lymphoma (rrNHL) (cut-off date: 1 September 2023)
- To further build a robust data package, patient recruitment of the Phase 1 dose-finding part of ATALANTA-1 is ongoing: 14 rrNHL patients with diffuse large B cell lymphoma, mantle cell lymphoma and indolent lymphoma were enrolled (7 at DL1 and 7 at DL2). In parallel, enrollment of the Phase 2 expansion study is ongoing, and the first 9 patients have been dosed.
- Presented encouraging preliminary Phase 1 and Phase 2 data at the ASH Annual Meeting, which demonstrated clinically meaningful results in severely compromised patient populations and highlighted the potential of Galapagos' point-of-care CAR-T manufacturing platform to deliver a fresh product with a median vein-to-vein time of only seven days.
- GLPG5301 (BCMA CAR-T) in relapsed/refractory multiple myeloma (rrMM)
- First patients dosed in the PAPILIO-1 Phase 1/2 study to evaluate the safety, efficacy and feasibility of point-of-care manufactured GLPG5301 in patients with rrMM after ?2 prior lines therapy.
- Continued to evolve our oncology research activities in biologics, cell therapies and small molecules to deliver best-in-class medicines for patients with high unmet medical need.
Immunology portfolio
- Jyseleca® (filgotinib) (JAK1): successfully transferred to Alfasigma S.p.A.
- Achieved reimbursement for both RA and UC across Western Europe. Sobi, the distribution and commercialization partner for filgotinib in Eastern and Central Europe, Portugal, Greece, and the Baltic countries, launched Jyseleca® in Poland and Slovenia in both RA and UC, and in Croatia and Greece for RA.
- The European Commission endorsed the recommendation of the Pharmaceutical Risk Assessment Committee (PRAC) to add safety measures for the JAK inhibitors class of medicines.
- Based on topline results from the Phase 3 DIVERSITY study in Crohn's disease, a Marketing Authorization Application (MAA) was not submitted in Europe in this indication and the MAA for filgotinib in UC in Switzerland did not proceed.
- First patients dosed in the pivotal Phase 3 OLINGUITO study in axial spondyloarthritis (AxSpA).
- Pipeline programs
- First patients dosed in the Phase 2 GALARISSO study of novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor, GLPG3667, in dermatomyositis (DM) and the Phase 2 GALACELA study in systemic lupus erythematosus (SLE).
- We initiated multiple small molecules programs to further build our immunology research pipeline.
Corporate update
- Thad Huston was appointed as Chief Financial Officer (CFO) and Chief Operating Officer (COO), succeeding Bart Filius, as of 1 July 2023.
- The Board of Directors appointed Dr. Susanne Schaffert and Mr. Simon Sturge as Non-Executive Independent Directors by way of cooptation, replacing respectively Dr. Rajesh Parekh and Dr. Mary Kerr, who stepped down.
- The Board of Directors granted 1,538,400 subscriptions rights under new subscription right plans, after acceptance by the beneficiaries.
- Successfully completed the integrated drug discovery collaboration transaction with NovAliX.
- Signed letter of intent with Alfasigma to transfer the entire Jyseleca® business to Alfasigma, including the European and UK Marketing Authorizations, as well as the commercial, medical and development activities for Jyseleca® and approximately 400 Galapagos positions in 14 European countries.
- Galapagos and Gilead amended the Filgotinib Agreement to terminate the existing 50/50 global development cost sharing arrangement with Galapagos bearing the costs going forward, and to terminate Galapagos' obligation to pay tiered royalties to Gilead on net sales of Jyseleca® in Europe, in addition to other amendments.
- Signed an agreement with Boston-based Landmark Bio and started the technology transfer for the decentralized production of Galapagos' CAR-T cell therapy candidates.
- Hosted a Key Opinion Leader event highlighting Galapagos' decentralized manufacturing platform and the data observed in the ongoing CD19 CAR-T Phase 1/2 studies.
Post-period events
- For strategic reasons, it was decided not to continue development of our CD19 CAR-T candidate in refractory systemic lupus erythematosus (rSLE).
- Participated in Series C financing round of Frontier Medicines, a pioneer in precision oncology with a unique technology platform and a pipeline of potential best-in-class assets that fit with Galapagos' precision oncology R&D approach. The investment aligns with our innovation acceleration strategy to bring transformational medicines to patients around the world.
- Poster presentation at the annual EBMT-EHA congress highlighting new preliminary translational data from EUPLAGIA-1, which demonstrate that Galapagos' point-of-care manufacturing platform has the potential to enable a single infusion of fresh early-phenotype CD19 CAR-T cells with robust expansion and persistence in patients with rrCLL and in patients with RT.
- Signed a share and asset purchase agreement with Alfasigma to transfer the entire Jyseleca® business to Alfasigma. As part of the transaction, the distribution agreement with Sobi and the amended Filgotinib Agreement between Galapagos and Gilead have been assigned to Alfasigma. The transaction was successfully completed on 31 January 2024. Freed-up resources will be reinvested in R&D growth areas.
- Michele Manto's mandate as Chief Commercial Officer and member of the Executive Committee of Galapagos ended in December 2023; he will join Alfasigma to lead the Jyseleca® business.
- Further streamlined our operations with a reduction of approximately 100 positions across the Galapagos organization to align with the Galapagos' renewed focus on innovation.
- Signed a strategic collaboration and license agreement with BridGene Biosciences to further strengthen Galapagos' growing early-stage oncology precision medicine pipeline.
- Entered into a strategic collaboration agreement with Thermo Fisher Scientific for CAR-T manufacturing and kitting services for Galapagos' point-of-care CAR-T product candidate in the San Francisco area.
Financial performance
Full year 2023 key figures (consolidated)
(€ millions, except basic & diluted income/loss (-) per share)
31 December 2023 | 31 December 2022 | % Change | |
Collaboration revenues | 239.7 | 241.2 | -1% |
Total net revenues | 239.7 | 241.2 | |
R&D expenditure | (241.3) | (269.8) | -11% |
G&Aii and S&Miii expenses | (134.0) | (138.6) | -3% |
Other operating income | 47.3 | 36.1 | +31% |
Operating loss | (88.3) | (131.1) | -33% |
Fair value adjustments and net exchange differences | 16.3 | 51.5 | -68% |