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Forward-looking statements
This press release contains forward-looking statements, all of which involve
certain risks and uncertainties. These statements are often, but are not always,
made through the use of words or phrases such as "believe," "anticipate,"
"expect," "intend," "plan," "seek," "upcoming," "future," "estimate," "may,"
"will," "could," "would," "potential," "forward," "goal," "next," "continue,"
"should," "encouraging," "aim," "progress," "remain,' "explore," "further" as
well as similar expressions. These statements include, but are not limited to,
the guidance from management regarding our financial results (including guidance
regarding the expected operational use of cash for the fiscal year 2024),
statements regarding our regulatory outlook, statements regarding the amount and
timing of potential future milestones, and other payments , statements regarding
our R&D plans, strategy and outlook, including progress on our oncology or
immunology portfolio, and potential changes in such strategy, statements
regarding our pipeline and complementary technology platforms facilitating
future growth, statements regarding our commercialization efforts for
filgotinib, our product candidates, and any of our future product candidates or
approved products, if any, statements regarding the global R&D collaboration
with Gilead and the amendment of our arrangement with Gilead for the
commercialization and development of filgotinib, statements regarding the
expected timing, design and readouts of our ongoing and planned preclinical
studies and clinical trials, including but not limited to (i) filgotinib in RA,
UC and AxSpA, (ii) GLPG3667 in SLE and DM, (iii) GLPG5101 in rrNHL and rSLE,
(iv) GLPG5201 in rrCLL, with or without RT, and (v) GLPG5301 in rrMM, including
recruitment for trials and topline results for trials and studies in our
portfolio, statements relating to interactions with regulatory authorities, and
statements related to our portfolio goals, business plans, and sustainability
plans. Galapagos cautions the reader that forward-looking statements are based
on our management's current expectations and beliefs and are not guarantees of
future performance. Forward-looking statements may involve known and unknown
risks, uncertainties and other factors which might cause actual events,
financial condition and liquidity, performance or achievements, or 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. In addition, even if Galapagos' results,
performance, financial condition and liquidity, and the development of the
industry in which it operates are consistent with such forward-looking
statements, they may not be predictive of results or developments in future
periods. Such risks include, but are not limited to, the risk that our
expectations and management's guidance regarding our 2024 cash burn may be
incorrect (including because one or more of its assumptions underlying our
revenue or 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 Galapagos' ongoing and planned clinical research programs in RA, UC, DM,
SLE, AxSpA, rrNHL, rSLE, rrCLL, rrMM and other indications or any other
indications or diseases, may not support registration or further development of
its product candidates due to safety or efficacy concerns or other reasons), the
inherent risks and uncertainties associated with target discovery and validation
and drug discovery and development activities, risks related to our reliance on
collaborations with third parties, the risk that the transfer of the Jyseleca®
business will not have the currently expected results for our business and
results of operations 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, including the risk that our plans with respect to CAR-T may not be
achieved on the currently anticipated timeline or at all, the risk that our
projections and expectations regarding the commercial potential of our product
candidates (if approved) or expectations regarding the costs and revenues
associated with the commercialization rights may be inaccurate, and risks
related to our strategic transformation exercise, including the risk that we may
not achieve the anticipated benefits of such exercise on the currently envisaged
timeline or at all. A further list and description 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 our subsequent filings and reports filed 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 the
result of our operations, financial condition and liquidity, or the industry in
which we operate, are consistent with such forward-looking statements, they may
not be predictive of results, performance or achievements 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 to reflect any change in our expectations or
any change in events, conditions or circumstances, unless specifically required
by law or regulation.
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(1) Throughout this press release, 'Dr. Paul Stoffels' should be read as 'Dr.
Paul Stoffels, acting via Stoffels IMC BV'
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(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, related to the acquisitions or
disposals of businesses; the acquisition of financial assets held at fair value
through profit or loss; 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.
This alternative liquidity measure is in our view an important metric for a
biotech company in the development stage. The operational cash burn for the year
2023 amounted to EUR414.8 million and can be reconciled to our cash flow statement
by considering the decrease in cash and cash equivalents of EUR339.8 million,
adjusted by (i) the cash proceeds from capital and share premium increase from
the exercise of subscription rights by employees for EUR1.8 million, (ii) the net
purchase of current financial investments amounting to EUR94.2 million, (iii) the
cash-out related to the acquisition of subsidiaries of EUR7.0 million, and (iv)
the acquisition of financial assets held at fair value through profit or loss of
EUR14.0 million.
(ii) General and administrative
(iii) Sales and marketing
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