Disclaimer and other information
This report contains all information required by Belgian law.
Galapagos NV is a limited liability company organized under the laws of Belgium and has its registered office at Generaal De Wittelaan L11 A3, 2800 Mechelen, Belgium. Throughout this report, the term “Galapagos NV” refers solely to the non-consolidated Belgian company and references to “we,” “our,” “the group” or “Galapagos” include Galapagos NV together with its subsidiaries.
This report is published in Dutch and in English. Galapagos is responsible for the translation and conformity between the Dutch and English versions. In case of inconsistency between the Dutch and the English versions, the Dutch version shall prevail.
This document is the PDF version of the report, and is a translation of the official Dutch language version in the European single electronic format (ESEF) of the Annual Report 2021. The official Dutch language ESEF version of the report is available on our website (www.glpg.com). Please note that the official ESEF version takes precedence over the PDF version.
This report, including the statutory financial statements of Galapagos NV, is available free of charge and upon request to be addressed to:
Generaal De Wittelaan L11 A3 2800 Mechelen
Tel: +32 15 34 29 00
A digital version of this report, including the statutory financial statements of Galapagos NV, is available on our website, www.glpg.com.
We will use reasonable efforts to ensure the accuracy of the digital version, but do not assume responsibility if inaccuracies or inconsistencies with the printed document arise as a result of any electronic transmission. Therefore, we consider only the printed version of this report to be legally valid. Other information on our website or on other websites does not form a part of this report.
As a U.S. listed company, we are also subject to the reporting requirements of the U.S. Securities and Exchange Commission, or SEC. An annual report will be filed with the SEC on Form 20‑F. The Form 20‑F is available in the SEC’s EDGAR database (https://www.sec.gov/edgar.shtml) and a link thereto is posted on our website.
With the exception of filgotinib’s approval for the treatment of (i) rheumatoid arthritis by the European Commission, Great Britain’s Medicines and Healthcare products Regulatory Agency and the Japanese Ministry of Health, Labour and Welfare, and (ii) ulcerative colitis by the European Commission and Great Britain’s Medicines and Healthcare products Regulatory Agency, our drug candidates mentioned in this report are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.
Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.
This report contains "forward-looking statements", all of which involve certain risks and uncertainties. When used in this report, the words “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “estimate,” “may,” “will,” “could,” “stand to,” “continue,” "further," "encouraging," "aim," and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this report include, but are not limited to, statements made in the “Letter from the management”, statements made in the section captioned “Outlook for 2022”, statements regarding guidance from management, including about the strategic re-evaluation and of the expected operational cash burn during financial year 2022, statements regarding expected financial results, statements regarding the amount and timing of potential future milestones, opt-in and/or royalty payments by Gilead, Galapagos’ strategic R&D ambitions and potential changes of such ambitions, statements regarding our expectations of commercial sales of filgotinib, statements regarding the global R&D collaboration with Gilead for the commercialization and development of filgotinib and the transition of European commercialization rights for filgotinib to us, statements regarding the expected timing, design and readouts of ongoing and planned clinical trials (i) with filgotinib in RA, UC and CD, including the MANTA/MANTA-RAy trials, (ii) with GLPG3667 in Pso and UC, (iii) GLPG3312, GLPG3970 and GLPG4399 in inflammation, (iv) GLPG2737 in ADPKD, (v) GLPG0555 in OA, (vi) GLPG3121 in IBD, (vii) GLPG4586 and GLPG4605 in fibrosis and (viii) GLPG4716 in lung fibrosis, statements related to the EMA's planned safety review of JAK inhibitors used to treat certain inflammatory disorders, including filgotinib, initiated at the request of the European Commission (EC) under article 20 of Regulation (EC) No 726/2004, statements regarding interactions with regulatory authorities, the timing or likelihood of additional regulatory authorities’ approval of marketing authorization for filgotinib for RA, UC or any other indication, including the IBD indication for filgotinib in Europe, Japan, and the U.S. and UC indication for filgotinib in Japan, and the U.S., statements regarding the timing or likelihood of pricing and reimbursement interactions for filgotinib, statements regarding the build-up of our commercial organisation for filgotinib, statements regarding the expected impact of COVID-19, and statements regarding our strategy, business plans and focus. We caution the reader that forward-looking statements are based on management's current expectations and beliefs, and are not guarantees of future performance. Forward-looking statements are subject to a number of known and unknown risks, uncertainties and other factors which might cause our actual results, financial condition and liquidity, performance or achievements, or the development of 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, including, without limitation, the risk that one or more assumptions, beliefs or expectations underlying management's guidance regarding our 2022 revenues, operating expenses, and financial results may be incorrect (including one or more of its assumptions underlying its expense expectations), risks related to the inherent uncertainties associated with competitive developments, clinical trial, product development activities and regulatory approval requirements (including that data from our clinical research programs in rheumatoid arthritis, Crohn’s disease, ulcerative colitis, inflammatory bowel disease, lung fibrosis, idiopathic pulmonary fibrosis, osteoarthritis, other inflammatory indications and kidney disease may not support registration or further development of our product candidates due to safety, efficacy, or other reasons, including ziritaxestat for IPF, systemic sclerosis or any other indication), risks related to our reliance on collaborations with third parties (including, but not limited to, our collaboration partner Gilead), risks related to completing the transition of European rights to filgotinib from Gilead to us, the risk that our projections and expectations regarding the commercial potential of filgotinib and any other product candidates may be inaccurate, risks related to continued regulatory review of filgotinib following approval by relevant regulatory authorities and the EMA's planned 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 marketing authorization for filgotinib in the EU be amended, the risk that the EMA may impose JAK class-based warnings, and the risk that the EMA’s planned safety review may negatively impact acceptance of filgotinib by patients, the medical community, and healthcare payors, the risk that Galapagos’ expectations regarding the costs and revenues associated with the transfer of European commercialization rights to filgotinib may be incorrect, and risks relating 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 Securities and Exchange Commission filing and reports, including in our most recent annual report on Form 20‑F filed with the Security and Exchange Commission, or SEC, and our subsequent filings and reports filed with the SEC. We also refer to the “Risk Factors” section of this report. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We expressly disclaim any obligation to update any such forward-looking statements in this document 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.