Galapagos NV Stock

Galapagos NV (Galapagos) operates as an integrated biopharmaceutical company. The company focuses on discovering, developing, and commercializing innovative medicines.

The company’s R&D capabilities cover multiple drug modalities, including small molecules and cell therapies. Its portfolio comprises discovery through to commercialized programs in immunology, oncology, and other indications. Its first medicine for rheumatoid arthritis and ulcerative colitis is on the market in Europe and Japan.

The company, through the acquisitions of CellPoint (CellPoint B.V.) and AboundBio, Inc. (AboundBio), gained access to a breakthrough, point-of-care CAR-T manufacturing platform, a clinical-stage CAR-T oncology pipeline and research capabilities for novel, differentiated CAR-T constructs, that together have the potential to deliver life-saving medicines to more patients, faster and more efficiently.

The company’s differentiated clinical pipeline includes preferential JAK1 inhibitor filgotinib, which is on the market in Europe and Japan, and for which the company intends to start a Phase 3 clinical trial in axial spondyloarthritis (AxSpA) in the first half of 2023; GLPG3667, a tyrosine kinase (TYK) 2 inhibitor for which the company intends to start a Phase 2 clinical trial in DM and in SLE in 2023; GLPG5101, a CD19 CAR-T (chimeric antigen receptor T cells) product candidate manufactured at point-of-care for which the company intends to start clinical development in rSLE in 2023; GLPG5101 and GLPG5201, CD19 CAR-T product candidates manufactured at point-of-care, in Phase 1/2 in rrNHL and rrCLL, respectively; and GLPG5301, a b cell maturation antigen (BCMA) CAR-T product candidate manufactured at point-of-care, for wich the company intends to start clinical development in rrMM. In both its immunology and oncology portfolios, the company has multiple product candidates in early research.

Lead Programs

Immunology

Small Molecules Pipeline

Jyseleca Franchise

Jyseleca in Rheumatoid Arthritis (RA)

In 2003, the company discovered JAK1 as a novel, differentiated target in an inflammation target discovery assay and subsequently developed filgotinib as a novel small molecule inhibitor with preferential selectivity for JAK1.

As of December 31, 2022, there were 4 Janus kinases (JAK) inhibitors approved for the treatment of RA in the five major European markets (EU5), including Jyseleca (filgotinib) an orally administered preferential JAK1 inhibitor.

In 2020, Jyseleca (filgotinib 200mg and 100mg) obtained regulatory approval in Europe, Great Britain, and Japan for the treatment of adult patients with moderate to severe active RA.

In 2021, the company took full ownership of the manufacturing and commercialization of Jyseleca in Europe and became the Marketing Authorization Holder (MAH) in 27 countries in Europe. Jyseleca is reimbursed in 15 countries for RA, including the major markets Germany, France, Spain, Italy, and Great Britain. In Central and Eastern Europe, Portugal, Greece and the Baltic countries, the company’s partner Swedish Orphan Biovitrum AB (Sobi) is responsible for the distribution and commercialization of Jyseleca.

Under the company’s amended collaboration agreement with Gilead, Gilead remains responsible for the commercialization and distribution of Jyseleca outside of Europe, including in Japan where Jyseleca is approved in RA and is co-marketed with Eisai.

Filgotinib has shown favorable results in terms of onset of action, efficacy, safety, and tolerability from the FINCH Phase 3 and DARWIN Phase 2 clinical programs.

As part of the filgotinib development program, the company initiated FINCH 4 in RA. The FINCH 4 study is a multi-center, open-label, long-term extension study to assess the safety and efficacy of filgotinib in patients with RA, which enrolled subjects who completed either the FINCH 1, FINCH 2, or FINCH 3 studies.

The company and Gilead Sciences, Inc (Gilead) published integrated safety data from 7 RA studies in Annals of the Rheumatic Diseases (Winthrop et al. 2021). Data were integrated from 3 Phase 3 studies (FINCH 1 – 3), 2 Phase 2 studies (DARWIN 1, 2), and 2 long-term extension studies (DARWIN 3, FINCH 4), including up to 5.6 years of filgotinib exposure, and over a median of 1.6 years. In this pooled analysis, filgotinib was well-tolerated, and no new safety concerns were identified. Adverse events of major adverse cardiovascular events (MACE) and deep venous thrombosis (DVT)/PE were rare and occurred in similar numbers among all treatment groups, and with a similar incidence rate across all dose groups. The data underscore the acceptable safety and tolerability profile of filgotinib as monotherapy and in conjunction with MTX/csDMARDs (conventional synthetic disease-modifying antirheumatic drugs) in RA.

In preclinical animal toxicology studies, when administered at doses beyond its approved dose in humans, filgotinib induced adverse effects on semen parameters. Consequently, the company and Gilead conducted dedicated male patient semen analysis studies in UC and CD patients called MANTA, and RA, ankylosing spondylitis (AS), and psoriatic arthritis (PsA) patients, called MANTA-RAy, concurrent to all Phase 3 programs.

In 2022, the company presented preliminary results from its first international, real-world arthritis study, FILOSOPHY, FILgotinib Observational Study Of Patient Health-related outcomes, at the American College of Rheumatology (ACR) Convergence 2022 meeting.

Jyseleca in Ulcerative Colitis (UC)

Filgotinib obtained regulatory approval for the treatment of adults with moderate to severe UC in the European Union in 2021, and in Great Britain and Japan in January and March 2022, respectively.

Filgotinib is marketed as Jyseleca in Europe and Japan for the treatment of adult patients with moderate to severe active UC who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Jyseleca (filgotinib) 100mg and 200mg are registered in the above-mentioned territories.

Jyseleca Reimbursement in UC in Europe

Jyseleca is marketed by Galapagos in Europe and is reimbursed in 13 countries in Europe, including the major markets Great Britain, France and Germany. In Central and Eastern Europe, Portugal, Greece and the Baltic countries, the company’s partner Sobi is responsible for the distribution and commercialization of Jyseleca.

Gilead is responsible for the distribution and commercialization of Jyseleca outside of Europe, including in Japan where Jyseleca is approved in UC and is co-marketed with Eisai.

Filgotinib 200mg has shown favorable results in terms of rapid onset of action, efficacy, safety, and tolerability from the SELECTION Phase 3 program in patients with moderate to severe UC.

In 2022, the company presented a set of new data from the SELECTION study and SELECTION long-term extension study in UC at the (ECCO 2022 annual conference. In 2023, the company presented additional new analyses from the SELECTION program with filgotinib at the annual ECCO congress.

Filgotinib in Crohn’s Disease (CD)

The FITZROY Phase 2 trial evaluated the efficacy and safety of 200mg once-daily filgotinib in 174 patients with moderate to severe active CD and mucosal ulceration, who were either anti-TNF naive or anti-TNF (tumor necrosis factor) failures. The FITZROY Phase 2 trial achieved the primary endpoint of clinical remission at Week 10, and filgotinib demonstrated a favorable tolerability profile consistent with the DARWIN trials in RA.

Gilead initiated the Phase 3 DIVERSITY trial with filgotinib in CD in November 2016, and following the company’s amended collaboration agreement with Gilead, Galapagos became the sole sponsor of DIVERSITY and the long-term extension study, and the parties completed the transfer of all data to Galapagos in March 2023.

On 8 February 2023, Galapagos announced topline results from the DIVERSITY study.

TYK2 Program: GLPG3667

GLPG3667 is an investigational reversible and selective TYK2 kinase domain inhibitor that was discovered by the company and evaluated in a Phase 1 healthy volunteer study in 2020. The Phase 1 study was a randomized, double-blind, placebo-controlled dose escalation study evaluating safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending oral doses of GLPG3667 for 13 days.

In 2022, the company initiated the preparations for the Phase 2 studies with GLPG3667 in dermatomyositis (DM) and systemic lupus erythematosus (SLE). The Phase 2 studies in DM and SLE are expected to start later in 2023.

SIK Program

The Salt-Inducible Kinases (SIK) belong to a novel class of targets with immune-modulatory function discovered in an inflammation phenotypic cell assay with the company’s proprietary target discovery platform. The search, identification, and validation for this novel class of targets started with the ambition to find novel druggable targets with a differentiating mechanism-of-action to develop new therapeutic candidates demonstrating an improved efficacy and safety profile relative to existing therapies. Although significant progress has been made with novel therapies in recent years, for instance in psoriasis, the unmet need to manage chronic inflammatory diseases related to joints, the bowel, and other organs remains an important objective in public health.

The SIK family, which includes 3 members SIK1, SIK2, and SIK3, has been shown to contribute to biologic pathways across multiple immune cells. SIK inhibition has the potential to reduce the production of pro-inflammatory cytokines coupled with enhanced production of immunoregulatory mediators. This unique mechanism-of-action offers the potential to restore the immune balance that is typically out of balance in autoimmune diseases, and differentiate product candidates from existing therapies that predominantly act by suppressing the immune system.

The company has been focusing its medicinal chemistry efforts on these targets, delivering over 5,000 synthesized molecules, and more than 11 different chemical series with different SIK-isoform selectivity profiles. The first lead molecule from this program, GLPG3970, a selective SIK2/SIK3 inhibitor, has demonstrated a response across several disease models that has led to the investigation of a series of early-stage clinical trials in psoriasis (CALOSOMA), UC (SEA TURTLE), and RA (LADYBUG). The topline results for GLPG3970 were announced in July 2021.

A second candidate, GLPG4399, selective for SIK3 was tested in a Phase 1 healthy volunteer study but will not be further pursued for clinical development.

The company learned that the SIK pathway has the potential to play an important role in inflammation and confirms the therapeutic potential of SIK inhibitors in inflammatory diseases. Although the company will not progress GLPG3970 and GLPG4399 further into clinical development, the study results are an essential part of the broad evidence package that it is assembling on its SIK program. This strengthens the company’s understanding of the best approach going forward. The company is performing medicinal chemistry activities with the goal to start preclinical development with a selective SIK inhibitor later in 2023.

CAR-T Pipeline

GLPG5101 in Refractory SLE

Recently published data from a pilot study indicate that CAR-T cell therapy may have the potential to achieve long-term drug-free systemic lupus erythematosus (SLE) remission. Given the company’s deep disease knowledge and expertise in the field of immunology and its novel approach in the manufacturing of CAR-T therapies at the point-of care, it plans to initiate a Phase 1b patient study with its CD19 CAR-T candidate, GLPG5101, later in 2023.

Oncology

Differentiating Approach

In 2022, the company entered the field of oncology, CAR-T, and antibody-therapy research and development through the acquisitions of CellPoint and AboundBio. The transactions provide the company with end-to-end capabilities in CAR-T therapy development and offer the potential for a paradigm shift in the space through the implementation of a breakthrough, decentralized point-of-care manufacturing model, and cutting-edge fully human antibody-based capabilities to design next-generation CAR-Ts and biologicals.

Point-of-care Manufacturing

Pipeline: CAR-T Candidates Manufactured at Point-of-care

GLPG5101 is the company’s second generation anti-CD19/4-1BB CAR-T product candidate, administered as an intravenous infusion of a fresh product candidate in a single fixed dose. Its feasibility, safety, and efficacy of point-of-care manufacturing are being evaluated in the ATALANTA Phase 1/2, open-label, multicenter study in patients with relapsed/refractory non-Hodgkin lymphoma (rrNHL).

In December 2022, the company presented initial data from the ATALANTA-1 Phase 1 study during a poster session at the 64th Annual American Society of Hematology (ASH) Congress in New Orleans, Louisiana. The study is enrolling rrNHL patients in Europe and the first expansion cohort for Mantle Cell Lymphoma, a form of NHL, is open for recruitment. The company intends to provide Phase 1 topline results around mid-2023.

GLPG5201: CD19 CAR-T in Relapsed and Refractory Chronic Lymphocytic Leukemia

EUPLAGIA-1 is an ongoing Phase 1/2 study in heavily pre-treated patients with refractory chronic lymphocytic leukemia (rrCLL) and small lymphocytic lymphoma (rrSLL), with or without RT, to evaluate the safety, efficacy, and feasibility of GLPG5201, a non-frozen CD19 CAR-T product candidate manufactured at point-of-care.

GLPG5201 is the company’s second generation anti-CD19/4-1BB CAR-T product candidate, administered as an intravenous infusion of a fresh product candidate in a single fixed dose.

The company presented initial encouraging safety and efficacy data from the EUPLAGIA -1 Phase 1 study during a poster session at the EBMT-EHA 5th European CAR-T cell Meeting in Rotterdam in February 2023 (EUPLAGIA-1 Phase 1 study data cut-off date: 9 Janurary 2023).

The EUPLAGIA-1 study is continuing to enrol rrCLL and rrSLL patients in Europe, including patients with Richter's transformation (RT), and the company intends to provide Phase 1 topline results around mid-2023.

GLPG5301: BCMA CAR-T in Relapsed and Refractory Multiple Myeloma

PAPILIO-1 is a Phase 1/2, open-label, multicenter study to evaluate the feasibility, safety, and efficacy of point-of-care manufactured GLPG5301, the company’s BCMA CAR-T product candidate, in patients with relapsed/refractory multiple myeloma (rrMM).

GLPG5301 is a second generation anti-BMCA/4-1BB CAR-T product candidate, administered as an intravenous infusion of a fresh product candidate in a single fixed dose. Each enrolled patient will be followed for 24 months.

The primary objective of the Phase 1 part of the PAPILIO-1 study is to evaluate safety and determine the recommended dose for the Phase 2 part of the study. Secondary objectives of the Phase 1 part of the study include assessment of efficacy and feasibility of point-of-care manufacturing of GLPG5301.

The primary objective of Phase 2 of the study is to evaluate the ORR while the secondary objectives include assessment of complete response rate (CRR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and feasibility of point-of-care manufacturing. The company expects to start enrolling patients with rrMM in Europe in the second quarter of 2023.

Other Pipeline

CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Program with GLPG2737 in autosomal dominant polycystic kidney disease (ADPKD).

Early 2023, the company completed the MANGROVE Phase 2 study with GLPG2737. MANGROVE was a randomized, double-blind, placebo-controlled trial evaluating a once-daily oral dose of GLPG2737. GLPG2737 or placebo is administered for 52 weeks, followed by an open-label extension period of 52 weeks, in ADPKD patients with rapidly progressing disease. The primary objectives of the trial were to assess the effect on growth of total kidney volume over 52 weeks compared to placebo, as well as overall safety and tolerability. The secondary objectives included renal function, pharmacokinetics, and pharmacodynamics.

The company decided not to-out-license the program due to lack of effect of GLPG2737 on kidney volume and renal progression compared to placebo. The open-label extension study was subsequently stopped.

Strategy

The company is a fully integrated biotechnology company united around a single purpose to transform patient outcomes worldwide through the relentless pursuit of life changing science and innovation for more years of life and quality of life.

In 2022, the company unveiled a new strategy to accelerate growth and value creation by reshaping the way it innovates and operates. This strategy provides a clear path forward based on three key pillars:

The company shifts from novel target-based discovery to patient-focused medical need research and development with a focus on its key therapeutic areas of immunology and oncology;

The company builds on its capabilities and de-risk R&D through multiple drug modalities, including CAR-T, small molecules and biologicals, and by focusing on best-in-disease validated targets in its strategic therapeutic areas with shorter time-to-patient potential;

The company increases its business development efforts to complement its internal pipeline and continue to work with its collaboration partner Gilead to bring more medicines to patients worldwide.

Together, these enable the company to significantly reduce time-to-results and accelerate delivery of transformational innovations and medicines to patients.

Intellectual Property

As of March 1, 2023, patent rights held by the company relating to its product candidates include the following:

Filgotinib Product Candidate: The company has seven U.S. patents claiming filgotinib compositions of matter, salts of filgotinib and methods of treatment using filgotinib, and one pending U.S. patent application. The company has two patents granted via the European Patent Office (EPO). Counterpart patent applications are also pending in Australia, Canada, and other foreign countries. The seven issued U.S. patents, two European Patents, and any additional patents that may be granted based on the company’s pending U.S. and foreign patent applications, are expected to expire in 2030, not including any potential extensions for the marketed product that may be available via supplementary protection certificates or patent term extensions. For example, supplementary protection certificates have been requested in Europe, and granted amongst others in France, Germany, the Netherlands, Italy, Norway, Sweden, Portugal, and Spain with an expiry date of 2035. In addition, the company has four granted U.S. patents and one pending U.S. application, with counterpart applications pending in other foreign countries, which are directed to certain physical forms, including polymorphic forms and compositions, of its filgotinib product candidate, and patents, if granted, based on these patent applications are estimated to expire in 2035, not including any potential extensions that may be available for the marketed product via supplementary protection certificates or patent term extensions. The company also has a U.S. patent, with counterpart applications pending in other foreign countries, related to the use of its filgotinib product candidate in cardiovascular disorders. Any patents, if granted, based on these patent applications are estimated to expire in 2036. The company additionally has a pending U.S. application, with counterpart pending application in other foreign jurisdictions, which relates to specific methods of treatment using filgotinib. Any patents, if granted, based on this patent application are estimated to expire in 2039. The company has a U.S. pending application, with counterpart pending application in other foreign jurisdictions, which relate to solid formulations of a filgotinib salt, including polymorphic forms and if granted, these patent application would be expected to expire in 2038. The company has additional patents and pending patent applications directed to the use of compounds related to its filgotinib product candidate and these patents, and patents that may be issued based on these pending patent applications, are expected to expire from 2029 to 2033, not including any potential extensions that may be available for the marketed product via supplementary protection certificates or patent term extensions.

GLPG3667 Product Candidate: The company has a pending U.S. patent application, as well as counterpart foreign patent applications that are pending in Australia, Canada, Europe, Japan and other foreign countries claiming GLPG3667 compositions of matter and methods of treatment using GLPG3667. Patents, if any, that issue based on this pending patent application are estimated to expire in 2038, not including any potential extensions for the marketed product that may be available via supplementary protection certificates or patent term extensions. The company also has three pending applications before the European Patent Office (EPO) relating to improved methods for treating inflammatory disorders using GLPG3667. Any patents, if granted, based on these patent applications are estimated to expire in 2042 and 2043 respectively.

GLPG5101 Product Candidate: The company has a pending patent application under the PCT, claiming methods of treatment using GLPG5101. Patents, if any, that issue based on this pending patent application are estimated to expire in 2043, not including any potential extensions for the marketed product that may be available via supplementary protection certificates or patent term extensions. In addition, the company has obtained an exclusive license outside China and Israel, to the use of the Cocoon in the manufacture of cell therapy for the treatment of hematological malignancies at the point-of-care.

GLPG5201 Product Candidate: The company has a collaboration agreement to develop GLPG5201 and has a pending patent application under the PCT, claiming methods of treatment using GLPG5201. Patents, if any, that issue based on this pending patent application are estimated to expire in 2043, not including any potential extensions for the marketed product that may be available via supplementary protection certificates or patent term extensions. In addition, the company has obtained, an exclusive license, to use GLPG5201 in combination with the Cocoon in the manufacture of cell therapy for the treatment of Chronic Lymphocytic Leukemia (CLL), ALL and Non-Hodgkin’s Lymphoma (NHL).

Collaborations

The company has entered into multiple collaboration agreements with pharmaceutical partners to fund discovery and development. The company expects to continue to collaborate selectively with pharmaceutical and biotechnology companies to leverage its discovery platform and accelerate product candidate development. The company’s alliances include the alliances with Gilead and the restructured alliance with AbbVie.

Option, License and Collaboration Agreement with Gilead Sciences, Inc. (Gilead)

In July 2019, the company entered into a 10-year global research and development collaboration with Gilead. It closed the transaction on August 23, 2019.

Under the terms of the option, license and collaboration agreement, Gilead received an exclusive research and development license for Gilead to conduct certain contributions contemplated by the license and collaboration agreement; and an option to acquire exclusive commercial licenses in all countries outside of Europe to all clinical programs of Galapagos (other than filgotinib, which is already subject to an existing collaboration between the parties, and certain other programs already committed to other companies) being developed during the 10-year initial option term of the collaboration (subject to extension in certain circumstances). Under the option, license and collaboration agreement, the company will continue to lead and fund all discovery and development of its programs until the end of the relevant Phase 2 clinical trials. After the completion of the relevant Phase 2 clinical study for each program, Gilead will have the option to acquire an exclusive commercial license to that program in all countries outside of Europe. If the option is exercised, Gilead and the company will co-develop the compound and share costs equally.

In addition, under the option, license and collaboration agreement, Gilead was deemed to have exercised its option, and an exclusive commercial license was granted in all countries outside of Europe, to ziritaxestat, the company’s Phase 3 candidate for idiopathic pulmonary fibrosis.

For GLPG1972, a drug candidate resulting from the company’s osteoarthritis collaboration with Servier that was subject to separate option and milestone payments under the option, license and collaboration agreement, Gilead declined to exercise its option under the agreement in November 2020.

Exclusive Collaboration Agreement with Gilead for Filgotinib

In December 2015, the company entered into a global collaboration agreement with Gilead to develop and commercialize filgotinib for the treatment of inflammatory indications. In connection with entering into the option, license and collaboration agreement with Gilead, in August 2019 the company amended and restated this agreement to increase its involvement in filgotinib’s global strategy and participate more broadly in the commercialization of filgotinib in Europe.

In December 2020, the company agreed to amend this agreement again, as a result of which it has assumed all development, manufacturing, commercialization and certain other rights for filgotinib in Europe through a transition largely completed at the end of 2021 and fully completed by the end of 2022. Gilead retains commercial rights and remains marketing authorization holder for filgotinib outside of Europe, including in Japan.

Under the terms of the collaboration, Gilead is primarily responsible for seeking regulatory approval of filgotinib in countries outside of Europe. Pursuant to the amended arrangements agreed in December 2020, the company is responsible for commercializing filgotinib in Europe.

The original filgotinib agreement included a co-promotion / co-commercialization option for filgotinib, which the company exercised with respect to eight European countries in December 2017. The company agreed in December 2020 with Gilead to transfer the sole right to commercialize filgotinib in Europe to it after a transition period, pursuant to which most activities were transferred to the company by December 31, 2021 and that the company intends to complete by December 31, 2022. Until December 31, 2021, the company continued to share equally with Gilead in the net profit and net losses in each of the Netherlands, Belgium, Luxembourg, France, Germany, Italy, Spain and the U.K. All commercial economics on filgotinib in Europe transferred to the company as of January 1, 2022, subject to payment of tiered royalties in Europe to Gilead, starting in 2024.

In September 2021, Gilead and Galapagos agreed to further amend the collaboration. Following such amendment, Galapagos assumed sponsorship of and operational and financial responsibility for the ongoing DIVERSITY clinical study, evaluating filgotinib in CD, and its long-term extension study. The transfer was intended to be completed by June 30, 2022 and completed by March 2023. From April 1, 2022, Galapagos was also solely responsible for all development costs for the DIVERSITY clinical study. In addition, if the European Medicines Agency (EMA) grants regulatory approval of filgotinib for the treatment of CD based on data from the DIVERSITY trial. On February 8, 2023, Galapagos announced that it decided not to submit a Marketing Authorization Application in Europe based on topline data from the DIVERSITY study and as a result, these adjustments to the royalties will not made. Gilead remains responsible for commercial activities outside of Europe.

In March 2022, Gilead and Galapagos agreed to further amend the collaboration. Following such amendment, Galapagos assumed sponsorship of and operational responsibility for the MANTA study and its long-term extension. The transfer was largely completed by December 31, 2022.

On March 28, 2022, filgotinib was approved by the Japanese Ministry of Health, Labour and Welfare for UC. Also in March 2022, Gilead and Galapagos agreed to further amend the collaboration by adding the following countries to the Galapagos territory: Andorra, San Marino, Monaco, and Vatican City.

Second Amended and Restated Collaboration Agreement with AbbVie

On October 24, 2018, the company and AbbVie amended and restated the CF collaboration agreement for a second time to restructure the entire collaboration.

Pursuant to the second amended and restated agreement, AbbVie took over all programs in CF. AbbVie obtained exclusive worldwide rights to the CF investigational drug candidate portfolio developed by the two companies in the course of the collaboration. The portfolio includes all potentiator and corrector candidates, with the exception of GLPG1837 and a specific arrangement for GLPG2737. The company retains rights to these two compounds for use outside the field of CF. AbbVie will be responsible for all future activities and will bear all costs associated with this portfolio in CF going forward.

The company retains exclusive global commercial rights to develop GLPG2737, a candidate C2 corrector, in all indications outside of CF. The company further retains exclusive global commercial rights to develop GLPG1837, a candidate potentiator, in all indications outside of CF. AbbVie is eligible for a low single digit royalty on future global commercial sales, if approved, in indications outside CF.

Exclusive License Agreement with MorphoSys AG

On November 5, 2021, the company and MorphoSys ended its collaboration by executing a transition agreement. Pursuant to this agreement, MorphoSys has the right to continue research and development activities for MOR106 in all indications. Galapagos also assigned and transferred all of its patent rights and know-how to MorphoSys, and in exchange Galapagos remains eligible to receive single-digit royalties upon the worldwide successful commercialization of MOR106.

Trademarks

The company owns various trademark registrations and applications, and unregistered trademarks, including GALAPAGOS, JYSELECA (in the European countries where the company commercializes filgotinib), and its corporate logo.

Government Regulation

Any products which the company receives FDA approval for are subject to continuing regulation by the FDA, including among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the U.S. Food and Drug Administration (FDA) with updated safety and efficacy information, product sampling and distribution requirements, tracking and tracing requirements, complying with certain electronic records and signature requirements, and complying with FDA promotion and advertising requirements.

History

Galapagos NV was founded in 1999. The company was incorporated in Belgium in 1999.