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On track for clinical read-outs and commercial readiness in 2020 First three-month 2020 financial results: Group revenues and other income of 106.9 million Operating loss of 44.6 million Net loss of 50.6 million Cash and

Key Takeaway: On track for clinical read-outs and commercial readiness in 2020 Webcast presentation tomorrow, 8 May 2020, at 14.00 CET / 8 AM ET, www.glpg.com, +32 2 404 0659, code 6118715 Mechelen, Belgium; 7 May 2020, 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG)

Full Press Release Details

On track for clinical read-outs and commercial readiness in 2020
Webcast presentation tomorrow, 8 May 2020, at 14.00 CET / 8 AM ET, www.glpg.com, +32 2 404 0659, code 6118715
Mechelen, Belgium; 7 May 2020, 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) announces its
unaudited Q1 results and key events, which are further detailed in its Q1 2020 report available on the Galapagos website, www.glpg.com.
Although the world faces an unprecedented pandemic, impacting families, businesses and financial markets globally, we have adapted to the new normal
with agility and resilience, said Onno van de Stolpe, CEO of Galapagos. We are in a very strong position, both financially and operationally, and remain on track to report on a number of later stage clinical trials throughout the
remainder of 2020. As a consequence of COVID-19 measures, patient recruitment in some Phase 2 and 3 studies with filgotinib is temporarily halted, and we see an impact on recruitment rates of the ISABELA Phase 3 program with ziritaxestat (GLPG1690)
in IPF. Importantly, pending approval, we are confident that we can hit the ground running for the successful launch of our first novel mode of action drug, filgotinib in RA, thereby delivering on our promise of becoming a fully integrated
Bart Filius, COO and CFO added, From a financial perspective, we ended the first quarter of 2020 with a strong cash balance,
positioning us well to grow our pipeline further and deliver on operational excellence for the anticipated commercial launch of filgotinib. Due to the temporary pause in recruitment of the filgotinib trials and some delays in the start of earlier
stage programs in light of COVID-19, our cash burni guidance for FY2020 is expected to be in the range of 400 and 430 million, down versus the previously stated cash burn
projection of 420 and 450 million.
The remainder of the year promises to be eventful for Galapagos.
We and our collaboration partner Gilead expect to report Phase 3 SELECTION trial data of filgotinib in ulcerative colitis in the second quarter. We also
anticipate approval of our first product candidate, filgotinib, in RA in the U.S., Europe, and Japan in the second half of 2020. Gilead and we plan to start the Phase 3 program with filgotinib in ankylosing spondylitis later in 2020.
Within our fibrosis portfolio, in the second half of the year, we anticipate reporting topline results from
the PINTA Phase 2 trial with GLPG1205 in IPF and, together with collaboration partner Gilead, from the NOVESA Phase 2a trial with ziritaxestat (GLPG1690) in SSc. In the meantime, we enrolled more than 1,000 patients and continue recruitment in our
landmark Phase 3 ISABELA program with ziritaxestat in IPF, together with Gilead, for which the outcome of the futility analysis is anticipated in the first half of 2021.
Also in the second half of 2020, we and Servier expect to report topline results from the ROCCELLA Phase 2b trial of GLPG1972 in knee osteoarthritis. Upon
successful completion of this trial, Gilead has the option to license development and commercialization rights in the U.S. for GLPG1972.
Toledo, our novel mode of action program in inflammation, we completed Phase 1 studies with our Toledo candidate medicines, GLPG3312 and GLPG3970 in healthy volunteers. Given the superior profile of GLPG3970 observed in Phase 1, we decided to
prioritize the further development of this compound. Subject to positive developments related to the COVID-19 pandemic, we still anticipate the start of several proof-of-concept patient trials with GLPG3970 in the second half of the year, with
topline results now expected in the first half of 2021.
Due to the impact of COVID-19 on the recruitment rate and trial starts, our cash burni guidance has been revised down and is now expected to be in the range of 400 and 430 million, compared to 420 and 450 million previously guided. The cash burn
includes milestone income from Gilead for potential regulatory approvals of filgotinib in RA.
Key figures first quarter report 2020 (unaudited)
( millions, except basic & diluted loss per share)
31 March 2020 group total 31 March 2019 group total
Revenues and other income 106.9 40.9
R&D expenditure (116.8 ) (83.2 )
S&M ii expenses (9.8 ) (1.7 )
G&A iii expenses (24.9 ) (9.2 )
Operating loss (44.6 ) (53.2 )
Fair value re-measurement of warrants (20.5 ) -
Net other financial result 14.8 4.7
Taxes (0.3 ) (0.1 )
Net result for the period (50.6 ) (48.7 )
Basic and diluted loss per share ( ) (0.78 ) (0.89 )
Current financial investments and cash and cash equivalents 5,722.4 1,222.9
Revenues and other income
Revenues and other income for the first three months of 2020 increased to 106.9 million compared to 40.9 million in the first three
months of 2019. The impact of the Gilead collaboration on our
revenues is 91.6 million, and consists of (i) the access and option rights to our drug discovery platform ( 56.2 million), and (ii) the filgotinib revenue recognition
As a result of the upfront payment received from Gilead in the third quarter of 2019, our deferred income on 31 March 2020
includes 2.2 billion allocated to our drug discovery platform that will be recognized linearly over 10 years, and 0.7 billion allocated to filgotinib (2015 filgotinib contract and recent revised collaboration combined) that will be
recognized over a period of 4 to 5 years.
We realized a net loss of 50.6 million for the first three months of 2020, compared to a net loss of 48.7 million for the first three
We reported an operating loss amounting to 44.6 million for the first three months of 2020, compared to an operating loss of
53.2 million for the first three months of 2019.
Our R&D expenditure in the first three months of 2020 amounted to
116.8 million, compared to 83.2 million for the first three months of 2019. This planned increase was mainly due to an increase of 19.4 million in subcontracting costs primarily related to our filgotinib program, our
Toledo program, and other clinical programs. Furthermore, personnel costs increased explained by a planned headcount increase following the growth in our R&D investments. This factor, and the increased cost of the commercial launch of filgotinib
in Europe, contributed to the increase in our S&M and G&A expenses, which were respectively 9.8 million and 24.9 million in the first three months of 2020, compared to respectively 1.7 million and
9.2 million in the first three months of 2019.
We reported a non-cash fair value loss from the re-measurement of initial warrant B issued to
Gilead, amounting to 20.5 million, as result of the increased implied volatility of the Galapagos share price.
Net other financial income in
the first three months of 2020 amounted to 14.8 million, compared to net other financial income of 4.7 million for the first three months of 2019, which was primarily attributable to a 34.3 million of unrealized
exchange gain on our cash position in U.S. dollars, partly compensated by a fair value loss on current financial investments of 14.5 million.
Current financial investments and cash and
cash equivalents totaled 5,722.4 million on 31 March 2020.
A total net decrease of 58.4 million in cash and cash equivalents
and current financial investments was recorded during the first three months of 2020, compared to a net decrease of 67.9 million during the first three months of 2019. This net decrease was composed of 83.4 million of
operational cash burni, offset by (i) 5.4 million of cash proceeds from capital and share premium increase from exercise of warrants in the first three months of 2020,
(ii) 19.6 million unrealized positive exchange rate differences and fair value losses on current financial investments.
balance sheet as at 31 March 2020 held a receivable from the French government (Cr dit d Imp t Rechercheiv) and a receivable from the Belgian Government for R&D
incentives, for a total of both receivables of 115.2 million.
First quarter report 2020
Galapagos financial report for the first three months ended March 2020, including new accounting policies as a result of recent transactions and details
of the unaudited consolidated results, is accessible via www.glpg.com/financial-reports.
Results of annual (ordinary) and extraordinary
shareholders meetings
On 28 April 2020, Galapagos held its annual (ordinary) and extraordinary shareholders meetings. Due to the
COVID-19 pandemic, the meetings were held behind closed doors, with advance shareholders participation only. All agenda items were approved, including the appointment of Dr. Elisabeth Svanberg as independent director, the remuneration
policy and -report, the amendment of the company s object and the amendment of the articles of association in light of the new Belgian Code of Companies and Associations. All documents relating to the shareholders meetings will be posted
Conference call and webcast presentation
Galapagos will conduct a conference call open to the public tomorrow, 08 May 2020, at 14:00 CET / 8 AM ET, which will also be
webcasted. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement:
USA: +1 323 794 2093
UK: +44 330 336 9105
Netherlands: +31 20 721 9251
France: +33 1 76 77 2274
Belgium: +32 2 404 0659
Or, select the click-to-join link and you ll get connected automatically.
A question and answer session will follow the presentation of the results. Go to www.glpg.com to access the live audio webcast. The archived webcast
will also be available for replay shortly after the close of the call.
06 August 2020 Half year 2020 results (webcast 07 August 2020)
05 November 2020 Third quarter 2020 results (webcast 06 November 2020)
18 February 2021 Full year 2020 results (webcast 19 February 2021)
Galapagos (Euronext & NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, three of which show promising patient
results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, osteoarthritis and other indications. Our ambition is to become
a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.
Filgotinib and all other drug candidates mentioned in this report are investigational; their efficacy and safety have not been fully evaluated by any
regulatory authority.
VP Investor Relations
Director Investor Relations
Senior Director Communications & Public
Director Communications
Forward-looking statements
This release may contain forward-looking statements, including, among other things, statements regarding the global R&D collaboration with Gilead, the
amount and timing of potential future milestone, opt-in and/or royalty payments by Gilead, Galapagos strategic R&D ambitions, the guidance from management (including guidance regarding the expected operational cash burn during financial
year 2020), financial results, timing and/or results of clinical trials, mechanisms of action and potential commercialization of our product candidates, interaction with regulators, the potential approval process for filgotinib and statements
relating to the build-up and development of commercial operations, the impact of COVID-19, and our strategy, business plans and focus. Galapagos cautions the reader that forward-looking statements are not guarantees of future performance.
Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, 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. 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. Among the factors that may result in differences
are that Galapagos expectations regarding its 2020 operating expenses may be incorrect (including because one or more of its assumptions underlying its expense expectations may not be realized), Galapagos expectations regarding its
development programs may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from Galapagos ongoing
clinical research programs may not support registration or further development of its product candidates due to safety, efficacy or other reasons), Galapagos reliance on collaborations with third parties (including our collaboration partner
for filgotinib and ziritaxestat, Gilead, and our collaboration partner for GLPG1972, Servier), and estimating the commercial potential of our product candidates and the uncertainties 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 Galapagos Securities and Exchange Commission (SEC) filings and reports, including in Galapagos 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 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. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its 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.
Last updated: May 11, 2020