changes of such plans, statements regarding our pipeline and complementary technology platforms facilitating future growth, statements regarding the expected timing, design and readouts of
ongoing and planned preclinical studies and clinical trials, including but not limited to (i) filgotinib in RA, UC and AxSpA, (ii) with SIKi compounds, including GLPG3667 in SLE and DM, (iii) GLPG5101 in rrNHL and rSLE,
(iv) GLPG5201 in rrCLL and rrSLL, and (v) GLPG5301 in rrMM, including recruitment for trials and topline results for our trials and studies in our portfolio, 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 any other indication for filgotinib, statements regarding our commercialization efforts for filgotinib, our product candidates,
and any of our future approved products, statements regarding our expectations on commercial sales of filgotinib and any of our product candidates (if approved), statements related to the EMAs 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 and regarding the related CHMP opinion and ECs decision, statements regarding the
timing or likelihood of pricing and reimbursement interactions for filgotinib, statements relating to the development of our commercial organization, statements and expectations regarding commercial sales for filgotinib, statements regarding our
plans and strategy related to the development of our CD19 CAR-T candidates, GLPG5101 and GLPG5201, including patient enrollment for the Phase 1/2 ATALANTA-1 study and the EUPLAGIA-1 study, and the timing for topline results from such studies,
statements regarding the timing for initiation of, the Phase 1/2 PAPILIO-1 study with BCMA CAR-T candidate, GLPG5301, statements regarding the timing and likelihood of business development projects and external innovation, and statements regarding
the changes in our leadership and expected resulting benefits. Any forward-looking statements in this release are based on managements current expectations and beliefs and are not guarantees of future performance. Forward-looking statements
involve known and unknown risks, uncertainties and other factors which might cause our actual results, financial condition and liquidity, performance or achievements to be materially different from any historic or future results, financial
conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. Such risks include, but are not limited to, the risk that our expectations regarding our 2023 revenues, operating expenses, cash burn and
other financial results may be incorrect (including because one or more of our assumptions underlying our revenue and expense expectations may not be realized), the risk that ongoing and future clinical trials may not be completed in the currently
envisaged timelines or at all, the inherent risks and uncertainties associated with competitive developments, clinical trials, recruitment of patients, product development activities and regulatory approval requirements (including the risk that data
from our ongoing and planned clinical research programs in RA, UC, DM, SLE, AxSpA, refractory/relapsed NHL, rrCLL, refractory/replapsed small lymphocytic lymphoma, rrMM and other immunologic indications or any other indications or diseases, may not
support registration or further development of our product candidates due to safety or efficacy concerns or other reasons), risks related to the acquisitions of CellPoint and AboundBio, including the risk that we may not achieve the anticipated
benefits of the acquisitions of CellPoint and AboundBio, risks related to the transfer of the drug discoveries and research activities conducted in Romainville (France) and employees exclusively dedicated to these activities to NovAliX, the inherent
risks and uncertainties associated with target discovery and validation and drug discovery and development activities, the risk that the preliminary and topline data from the OLINGUITO, ATALANTA-1, EUPLAGIA-1, GALARISSO, PAPILIO-1, FILOSOPHY, and
GALACELA-studies may not be reflective of the final data, risks related to our reliance on collaborations with third parties (including, but not limited to, our collaboration partner Gilead, Sobi and Lonza), risks related to the implementation of
the transition of the European commercialization responsibility of filgotinib from Gilead to us, including the transfer of the supply chain, and the risk that the transition will not have the currently expected results for our business and results
of operations, the risk that our plans with respect to our CAR-T programs may not be achieved on the currently anticipated timeline or at all, the risk that our estimates of the commercial potential of our product candidates or expectations
regarding the costs and revenues associated with the commercialization rights may be inaccurate, the risk that we will not be able to continue to execute on our currently contemplated business plan and/or will revise our business plan, the risks
related to our strategic transformation, including the risk that we may not achieve the anticipated benefits of such exercise on the currently envisaged timeline or at all, the risk that we will be unable to successfully achieve the anticipated
benefits from our leadership transition, the risk that we will encounter challenges retaining or attracting talent, risks related to potential disruptions in our operations, supply chain or ongoing studies due to the conflict between Russia and
Ukraine, the risk that the EMA may impose JAK class-based warnings, and the risk that the EMAs safety review may negatively impact acceptance of filgotinib by patients, the medical community, and healthcare payors, the risk that regulatory
authorities may require additional post-approval trials of filgotinib or any other product candidates that are approved in the future, and the risks and uncertainties relating to the impact of the COVID-19 pandemic. A further discussion of these
risks, uncertainties and other risks can be found in our filings and reports with the Securities and Exchange Commission (SEC), including in our most recent annual report on Form 20-F filed with the SEC and other filings and reports filed by
Galapagos with the SEC. Given these risks and uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. In addition, even if our results, performance, financial condition and liquidity, and the
development of the industry in which we operate are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication
of this release. We expressly disclaim any obligation to update any such forward-looking statements in this release unless required by law or regulation.
i The operational cash burn (or operational cash flow if this liquidity measure is positive) is equal to
the increase or decrease in our cash and cash equivalents (excluding the effect of exchange rate differences on cash and cash equivalents), minus:
|
|
|
the net proceeds, if any, from share capital and share premium increases included in the net cash flows generated
from/used in (-) financing activities |
|
|
|
the net proceeds or cash used, if any, in acquisitions or disposals of businesses; the movement in restricted
cash and movement in current financial investments, if any, the cash advances and loans given to third parties, if any, included in the net cash flows generated from/used in (-) investing activities |
|
|
|
the cash used for other liabilities related to the acquisition of businesses, if any, included in the net cash
flows generated from/used in (-) operating activities. |