Key 2022 and post-period events

Dr. Paul Stoffelsi appointed as Chief Executive Officer and Chairman of the Board of Directors
Implemented new strategic direction to accelerate innovation and time-to-patients:
Set-up of new innovation model and fit-for-purpose R&D organization
Focus on key therapeutic areas of immunology and oncology
Discontinuation of activities in fibrosis and kidney disease
Expansion of drug modalities beyond small molecules, including biologicals and CAR-T
Entered into the field of oncology through the acquisitions of CellPoint and AboundBio
Presented encouraging initial safety and efficacy data from two ongoing Phase 1/2 studies in patients with refractory/relapsed non-Hodgkins lymphoma (NHL) and chronic lymphocytic leukemia (CLL) with CD19 CAR-T candidates, GLPG5101 and GLPG5201, manufactured at point-of-care
Jyseleca® sales of €87.6 million, at the upper end of the guidance of €80-90 million
Jyseleca® reimbursed for rheumatoid arthritis (RA) in 15 countries and for ulcerative colitis (UC) in 11 countries
The Committee for Medicinal Products for Human Use (CHMP) adopted the Pharmacovigilance Risk Assessment Committee (PRAC)’s recommendation to harmonize the European label of all approved JAK inhibitors for chronic inflammatory disorders following an extensive safety review (Article 20 procedure)
Received positive opinion from the CHMP for Jyseleca® European label update based on testicular function safety data from MANTA/RAy semen parameter studies
Announced topline results from Phase 3 DIVERSITY trial of filgotinib in Crohn’s disease and, based on these topline data, decided not to submit a Marketing Authorization Application in Europe

2022 financial results

Group net revenues of €505.3 million compared to €484.8 million in 2021
Operating loss of €267.5 million compared to €165.6 million in 2021
Net loss of €218.0 million compared to €103.2 million in 2021
Cash and current financial investments of €4.1 billion on 31 December 2022
Operational cash burnii of €513.8 million, which is within the guided range

Webcast presentation tomorrow, 24 February 2023, at 14.00 CET / 8 AM ET, www.glpg.com

Mechelen, Belgium; 23 February 2023, 22.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) reports 2022 results, supported by strong adoption of Jyseleca® across Europe, and provides outlook for 2023.

Commenting on the full year results 2022, Dr. Paul Stoffels, CEO and Chairman of the Board of Directors of Galapagos said: “As I reflect on my first year as the new CEO and Chairman, we can be proud of what we have achieved in a very short time to reset our organization and embrace a new R&D strategy for a sustainable future. 2022 was a year of transformation and change.

Adding oncology as a new strategic therapeutic area, and CAR-T and biologicals as novel drug modalities, were key steps in our transformation. Through the acquisitions of CellPoint and AboundBio, we gained access to a breakthrough, point-of-care CAR-T manufacturing platform, a clinical-stage CAR-T oncology pipeline and a research engine for novel, differentiated CAR-T constructs, that together have the potential to deliver life-saving medicines to more patients, faster and more efficiently.

In addition, we remain fully committed to immunology, an area where there is still significant unmet patient need and for which we have built deep scientific know-how and expertise since our founding. With our programs targeting multiple modes-of-action and drug modalities, most recently including CAR-T, we have a differentiated portfolio of preclinical through to commercial assets.”

Bart Filius, President, COO and CFO of Galapagos, added: “We are very proud that our first marketed medicine, Jyseleca®, an orally administered JAK1 preferential inhibitor, continued to deliver solid in-market performance with a growing European base and €87.6 million in net sales for the year 2022, reaching 18,000 patients with RA and UC across Europe. Based on the topline results from the Phase 3 DIVERSITY study of filgotinib in Crohn’s disease, Galapagos decided not to submit a Marketing Authorization Application in Europe in this indication. On the other hand, following the positive opinion from the Committee for Medicinal Products for Human Use on the Type II variation application based on the safety data on semen parameters from the MANTA and MANTA-RAy studies, the European label for RA and UC has been updated, potentially broadening access for European patients who may benefit from this treatment. For 2023, we anticipate net Jyseleca® sales in a range between €140 and €160 million. For the longer term, we believe Jyseleca® can reach €400 million peak sales in RA, UC and axial spondyloarthritis.

Financially, we ended 2022 with a strong balance sheet of €4.1 billion in cash and current financial investments, which provides us with the necessary means to look for additional external innovation to accelerate our R&D portfolio while progressing our internal programs. As part of our company transformation, we have meaningfully reduced our cost base. We anticipate our full year 2023 operating cash burn to decline to a range of €380 to €420 million.”

2022 operational review and post-period events

Jyseleca® commercial & regulatory progress

Adoption across Europe with reimbursement for RA in 15 countries and for UC in 11 countries
Sobi, our distribution and commercialization partner in Eastern and Central Europe, Portugal, Greece, and the Baltic countries, launched Jyseleca® in RA in the Czech Republic and Portugal, resulting in €2.0 million milestone payments to Galapagos
The Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain and the Ministry of Health, Labour and Welfare (MHLW) in Japan approved filgotinib 200mg for the treatment of moderate to severe UC
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use, CHMP, adopted the recommendation of the PRAC to add measures to minimize risk of serious side effects with JAK inhibitors used for chronic inflammatory disorders
Positive opinion issued by the CHMP for Jyseleca’s® European label update based on testicular function safety data from MANTA/RAy semen parameter studies

Pipeline update

Started preparations to initiate a Phase 2 program with TYK2 inhibitor GLPG3667 in dermatomyositis (DM) and systemic lupus erythematosus (SLE)
Discontinued our activities in fibrosis and kidney disease as a result of our new strategic therapy area focus
Phase 2 study with GLPG2737 in polycystic kidney disease is ongoing with topline results expected in the first half of 2023. If successful, we aim to outlicense the program
Halted development of SIK3 inhibitor GLPG4399; medicinal chemistry activities to identify SIK inhibitors with improved pharmacology continues
Reported initial encouraging safety and efficacy data at ASH1 2022 from the ongoing ATALANTA-1 Phase 1/2 study in refractory/relapsed NHL with CD19 CAR-T candidate, GLPG5101, manufactured at point-of-care

Corporate update

Appointed Dr. Paul Stoffels as Chief Executive Officer, succeeding Onno Van de Stolpe, as of 1 April 2022. Following approval by Galapagos’ shareholders on 26 April 2022, adopted a 1-tier governance model and Dr. Paul Stoffels was appointed Chairman of the Board of Directors
Implemented new strategic direction to accelerate innovation and time-to-patients, focused on key therapeutic areas of immunology and oncology, diversifying beyond small molecules to include CAR-T and biologicals, and set up of a fit-for-purpose R&D organization
Entered the field of oncology through the acquisitions of CellPoint and AboundBio in all-cash transactions against payment of an upfront amount of €125 million for CellPoint, with an additional €100 million to be paid upon achievement of certain milestones, and against payment of $14 million for AboundBio
Received various transparency notifications from EcoR1 Capital LLC and FMR LLC, indicating that their shareholding in Galapagos increased, crossing the 5% threshold, to 5.2% and 5.9% respectively, of our current outstanding shares
Raised €6.7 million through the exercise of subscription rights
Announced changes to the Executive Committee: Dr. Walid Abi-Saab (Chief Medical Officer) and Dr. André Hoekema (Chief Business Officer) retired from the company, and Valeria Cnossen (General Counsel) and Annelies Missotten (Chief Human Resources Officer) were appointed as new members of the Executive Committee as of 1 January 2023
Post-period events

Poster presentation at the annual EBMT-EHA2 congress demonstrating initial encouraging safety and efficacy results from the ongoing EUPLAGIA-1 Phase 1/2 study with point-of-care manufactured CD19 CAR-T candidate, GLPG5201, in patients with refractory/replapsed CLL and small lymphocytic lymphoma (rrSLL), with or without Richter’s transformation (RT). All 7 out of 7 eligible rrCLL patients, including 4 patients with RT, responded to treatment (Objective Response Rate of 100%), and GLPG5201 showed an acceptable safety profile with no cytokine release syndrome (CRS) higher than grade 2, and no immune effector cell-associated neurotoxicity syndrome (ICAN) observed
Announced topline results from the DIVERSITY study, a combined induction and maintenance Phase 3 study of filgotinib in Crohn’s disease. While the co-primary endpoints for filgotinib 200mg in the maintenance part of the study were met and the observed safety profile is consistent with its known safety profile, the two induction cohorts missed the co-primary endpoints of clinical remission and endoscopic response at Week 10. Galapagos decided not to submit a Marketing Authorization Application in Europe based on these topline data
Financial performance

Key figures 2022 (consolidated)
(€ millions, except basic & diluted loss per share)

see & read more on
https://www.glpg.com/press-release/3780/galapagos-announces-full-year-2022-results-and-outlook-for-2023