Lakefront Biotherapeutics NV 6-K, filed Aug 5, 2021
Lakefront Biotherapeutics NV (LKFT)
About this 6-K
Lakefront Biotherapeutics NV filed this 6-K on August 5, 2021.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2021
Commission File Number: 001-37384
GALAPAGOS NV
(Translation of registrant's name into English)
Generaal De Wittelaan L11 A3
2800 Mechelen, Belgium
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [ X ] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
First Half-Year 2021 Results
On August 5, 2021, the Registrant announced its unaudited first half-year results for 2021, which are further described in an H1 2021 report.
Exhibit |
| Description |
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99.1 |
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99.2 |
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101.INS |
| XBRL Instance Document | |
101.SCH |
| XBRL Taxonomy Extension Schema Document | |
101.CAL |
| XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF |
| XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB |
| XBRL Taxonomy Extension Label Linkbase Document | |
101.PRE |
| XBRL Taxonomy Extension Presentation Linkbase Document | |
The information contained in this Report on Form 6-K, including the exhibits, except for the quotes of Onno van de Stolpe and Bart Filius contained in Exhibit 99.1, is hereby incorporated by reference into the Company’s Registration Statements on Forms F-3 (File No. 333-230639) and S-8 (File Nos. 333-204567, 333-208697, 333-211834, 333-215783, 333-218160, 333-225263 and 333-231765).
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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| GALAPAGOS NV |
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| (Registrant) |
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Date: August 5, 2021 | /s/ Annelies Denecker |
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| Annelies Denecker |
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| Company Secretary ad interim |
Exhibit 99.1
Galapagos reports H1 financial results with refocused pipeline and operational progress
| ● | First half-year 2021 financial results: |
| o | Group revenues and other income of €277.2 million |
| o | Operating loss of €97.6 million |
| o | Net loss of €55.0 million |
| o | Cash and current financial investments of €5.0 billion on June 30, 2021 |
| ● | Advancing refocused pipeline; encouraging clinical read-outs reported in earlier-stage inflammatory programs |
| ● | Commercial launch of filgotinib in Europe on track |
| ● | Executing on operational restructuring and savings program |
Webcast presentation tomorrow, August 6, 2021, at 14.00 CET / 8 AM ET, www.glpg.com, +32 2 793 38 47, code 8245817
Mechelen, Belgium; August 5, 2021, 22.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) is pleased to report progress on earlier-stage programs as well as its commercial launch of filgotinib in Europe. Following the recent setbacks, the company is moving forward with its revised strategy and operational restructuring announced in May. The unaudited H1 financial and operational results are further detailed in the H1 2021 report available on the website, www.glpg.com.
“Multiple assets are moving through clinical development, and we recently reported positive topline data on our TYK2 compound GLPG3667. In a Phase 1b trial in psoriasis (Pso), clinical activity was observed at 4 weeks, combined with an encouraging safety and tolerability profile. We are currently running an extended dose escalation study in healthy volunteers, and plan to progress GLPG3667 to a Phase 2b dose finding study in Pso as well as a Phase 2 study in ulcerative colitis (UC) in 2022.
We continue to develop our SIK portfolio of molecules, and recently reported encouraging early data from the first patient studies with SIK2/3 inhibitor GLPG3970. In a Phase 1b trial in Pso (CALOSOMA), clinical activity was observed at 6 weeks, and in a Phase 2a trial in UC (SEA TURTLE), biologically important effects were observed on a number of objective endpoints, both of which point to the potential of SIK inhibition as a novel mode of action in inflammation. No activity was observed in the LADYBUG study in rheumatoid arthritis (RA). GLPG3970 was generally safe and well tolerated. Based on these encouraging data, we work on optimizing the pharmacology of follow-up compounds from our SIK portfolio, and plan to bring an improved SIK2/3 molecule into the clinic in 2022.
On the commercial side, we report rapid progress in establishing our commercial operations for Jyseleca across Europe, with 11 countries launched to date. Reimbursement procedures are on track, and we are on target to achieve our commercial objectives.
We remain excited about the potential of our target discovery platform, our drug development capabilities, and the strength of our teams. We want to thank our shareholders for their continued support and patience as we are working hard to build our pipeline and establish Galapagos as a fully integrated European biopharma,” said Onno van de Stolpe, CEO of Galapagos.
Bart Filius, President and COO, added, “Following the strategic exercise announced at Q1, we are focused on advancing our pipeline, implementing our savings program, and diligently evaluating business development opportunities. At the same time, we have been delivering on the launch of Jyseleca, building out our organization in new European markets. In line with our review, we reiterate our 2021 operational cash burni guidance of between €580 million and €620 million. We believe that the decisions and actions taken put us on the strongest footing for the future. We look forward to a busy second half of the year, not the least of which is the expected outcome of the regulatory review in Europe of Jyseleca in UC.”
Key figures first half-year report 2021 (unaudited)
(€ millions, except basic & diluted loss per share)
| June 30, 2021 group total | June 30, 2020 group total (*) |
Revenues and other income | 277.2 | 217.2 |
R&D expenditure | (268.8) | (262.9) |
(106.0) | (88.7) | |
Operating loss | (97.6) | (134.4) |
Fair value re-measurement of financial instruments | 2.8 | (21.1) |
Net other financial result | 17.1 | (13.0) |
Income taxes | 0.5 | (0.7) |
Net loss from continuing operations | (77.2) | (169.2) |
Net income from discontinued operations | 22.2 | 3.6 |
Net loss of the period | (55.0) | (165.6) |
Basic and diluted loss per share (€) | (0.84) | (2.55) |
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Current financial investments and cash and cash equivalents | 5,006.6 | 5,566.5 |
(*) The 2020 comparatives have been restated to consider the impact of classifying the Fidelta business as discontinued operations in 2020.
Details of the financial results
Due to the sale of our fee-for-service business (Fidelta) to Selvita on January 4, 2021 for a total consideration of €37.1 million (including customary adjustments for net cash and working capital), the results of Fidelta are presented as “Net income from discontinued operations” in our unaudited condensed consolidated income statements for the six months ended June 30, 2021 and June 30, 2020.
Revenues and other income from continuing operations
Our revenues and other income from continuing operations for the first six months of 2021 increased to €277.2 million compared to €217.2 million in the first six months of 2020. Our revenues from the Gilead collaboration in the first six months of 2021 (€253.2 million) related to (i) the exclusive access to our drug discovery platform (€115.7 million), (ii) the filgotinib revenue recognition (€136.1 million) and (iii) royalties (€1.4 million).
Our deferred income balance on June 30, 2021 includes €1.9 billion allocated to our drug discovery platform that is recognized linearly over 10 years, and €0.7 billion allocated for the filgotinib development (including considerations for the previous and the renegotiated collaboration combined) that is recognized over time until the end of the development period.
Results from continuing operations
We realized a net loss from continuing operations of €77.2 million for the first six months of 2021, compared to a net loss of €169.2 million for the first six months of 2020.
We reported an operating loss amounting to €97.6 million for the first six months of 2021, compared to an operating loss of €134.4 million for the same period last year.
Our R&D expenditure in the first six months of 2021 amounted to €268.8 million, compared to €262.9 million for the first six months of 2020. This increase, primarily related to our filgotinib program and our Toledo program, was compensated by a decrease for ziritaxestat, the osteoarthritis (OA) program with GLPG1972, and the program in atopic dermatitis (AtD) with MOR106. Personnel costs increased due to an increase in headcount compared to the same period last year, and
increased costs of our subscription right plans. 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 €29.1 million and €76.9 million in the first six months of 2021, compared to respectively €26.9 million and €61.8 million in the first six months of 2020.
We reported a non-cash fair value gain from the re-measurement of initial warrant B issued to Gilead, amounting to €2.8 million, mainly due to the decreased implied volatility of the Galapagos share price and its evolution between December 31, 2020 and June 30, 2021.
Net other financial income in the first six months of 2021 amounted to €17.1 million, compared to net other financial loss of €13.0 million for the first six months of 2020, which was primarily attributable to €33.4 million of currency exchange gain on our cash and cash equivalents and current financial investments in U.S. dollars, to €8.7 million of negative changes in (fair) value of current financial investments and financial assets and to €4.4 million of interest expenses. The other financial expenses also contained the effect of discounting our long term deferred income of €4.8 million.
Results from discontinued operations
The net income from discontinued operations for the six months ended June 30, 2021 consisted of the gain on the sale of Fidelta, our fee-for-services business, for €22.2 million.
Group net results
We reported a group net loss for the first six months of 2021 of €55.0 million, compared to a group net loss of €165.6 million for the first six months of 2020.
Cash position
Current financial investments and cash and cash equivalents totaled €5,006.6 million on June 30, 2021, as compared to €5,169.3 million on December 31, 2020.
Total net decrease in cash and cash equivalents and current financial investments amounted to €162.7 million during the first six months of 2021, compared to a net decrease of €214.3 million during the first six months of 2020. This net decrease was composed of (i) €223.2 million of operational cash burn, (ii) offset by €2.6 million of cash proceeds from capital and share premium increase from exercise of subscription rights in the first six months of 2021, (iii) €5.8 million negative changes in (fair) value of current financial investments and €35.0 million of mainly positive exchange rate differences, (iv) €28.7 million cash in from disposal of subsidiaries, net of cash disposed.
Finally, our balance sheet on June 30, 2021 held a receivable from the French government (Crédit d’Impôt Rechercheiv) and a receivable from the Belgian Government for R&D incentives, for a total of both receivables of €142.7 million.
Outlook 2021
In 2021, we expect the European regulatory assessment of filgotinib for the treatment of UC and anticipate both an opinion from the Committee for Medicinal Products for Human Use (CHMP) and a decision from the European Commission later this year. We also expect additional reimbursement decisions for filgotinib in RA across a number of European countries. We are on track to complete the transition from our collaboration partner Gilead to us of the full European commercial operations for filgotinib by year-end, and we anticipate reporting on our own European sales of filgotinib starting in the second half of the year.
Completion of the recruitment in the global DIVERSITY Phase 3 trial with filgotinib in Crohn’s disease by our collaboration partner Gilead is also expected later this year.
With regard to our SIK portfolio, we are advancing our SIK3 inhibitor GLPG4399 in healthy volunteers this year, and we aim to advance a follow-up SIK2/3 preclinical candidate into the clinic in 2022.
Following the positive topline data from our TYK2 inhibitor, GLPG3667, we are currently running an extended dose escalation study in healthy volunteers, and we are preparing for a Phase 2b trial in Pso and a Phase 2 trial in UC next year.
In our other programs, by year-end we intend to finalize recruitment into the GLPG2737 Phase 2a trial in polycystic kidney disease.
Following the previously announced review of our plans for 2021, we reiterate our guidance for full year 2021 operational cash burn of €580 to €620 million.
First half-year report 2021
Galapagos’ financial report for the first half-year ended June 30, 2021, including details of the unaudited consolidated results, is accessible via www.glpg.com/financial-reports.
Conference call and webcast presentation
Galapagos will conduct a conference call open to the public tomorrow, August 6, 2021, 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:
CODE: 8245817
Standard International: | +44 (0) 2071 928338 |
USA: | +1 646 741 3167 |
UK: | +44 844 481 9752 |
Netherlands: | +31 207 95 66 14 |
France: | +33 1 70 70 0781 |
Belgium: | +32 2 793 38 47 |
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.
Financial calendar
November 4, 2021 | Third quarter 2021 results | (webcast November 5, 2021) |
February 24, 2022 | Full year 2021 results | (webcast February 25, 2022) |
About Galapagos
Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in clinical development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis 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.
Except for filgotinib’s approval for the treatment of rheumatoid arthritis by the European Commission, Great Britain’s Medicines and Healthcare products Regulatory Agency and Japanese Ministry of Health, Labour and Welfare, our drug candidates 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.
Contact
Investors:
Elizabeth Goodwin
VP Investor Relations
+1 781 460 1784
Sofie Van Gijsel
Senior Director Investor Relations
+1 781 296 1143
Sandra Cauwenberghs
Director Investor Relations
+32 495 58 46 63
ir@glpg.com
Media:
Carmen Vroonen
Global Head of Communications & Public Affairs
+32 473 824 874
communications@glpg.com
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 milestones, opt-in and/or royalty payments by Gilead, Galapagos’ strategic R&D ambitions, including progress on our fibrosis portfolio and Toledo platform, and potential changes of such ambitions, the guidance from management (including guidance regarding the expected operational use of cash during financial year 2021), financial results, statements regarding the expected timing, design and readouts of ongoing and planned clinical trials, including recruitment for trials and topline results for our trials and studies in our inflammation portfolio, statements regarding the strategic re-evaluation, 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, including UC and IBD indication for filgotinib in Europe, Great-Britain, Japan, and the U.S., such additional regulatory authorities requiring additional studies, the timing or likelihood of pricing and reimbursement interactions for filgotinib, statements relating to the build-up of our commercial organization, statements and expectations regarding commercial sales for filgotinib, the expected 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 our expectations regarding our 2021 revenues and financial results and our 2021 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 the risk that data from Galapagos’ ongoing and planned clinical research programs in rheumatoid arthritis, Crohn’s disease, ulcerative colitis, idiopathic pulmonary fibrosis, osteoarthritis, other inflammatory indications and kidney disease 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 Gilead), the timing of and the risks related to the implementation of the transition of the European commercialization responsibility of filgotinib from Gilead to us, estimating the commercial potential of our product candidates and Galapagos’ expectations regarding the costs and revenues associated with the transfer of European commercialization rights to filgotinib may be incorrect, 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.
i The operational cash burn (or operational cash flow if this performance 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:
| i. | the net proceeds, if any, from share capital and share premium increases included in the net cash flows generated from/used in (-) financing activities |
| ii. | 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, included in the net cash flows generated from/used in (-) investing activities. |
This alternative performance measure is in our view an important metric for a biotech company in the development stage.
The operational cash burn for the six months ended June 30, 2021 amounted to €223.2 million and can be reconciled to our cash flow statement by considering the increase in cash and cash equivalents of €477.4 million, adjusted by (i) the cash proceeds from capital and share premium increase from the exercise of subscription rights by employees for €2.6 million, (ii) the net sale of current financial investments amounting to €669.4 million, and (iii) the cash in from sale of subsidiaries, net of cash disposed, of €28.7 million.
ii General and administrative
iii Sales and marketing
iv Crédit d’Impôt Recherche refers to an innovation incentive system underwritten by the French government
Exhibit 99.2
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Unaudited condensed consolidated interim financial statements | 14 |
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Galapagos NV • H1 Report 2021
Letter from the management
Dear shareholders,
The business of biotech is not like any other. It takes grit, patience, persistence, and a lot of hard work, with the risk of disappointing outcomes of clinical trials, perhaps especially when going for novel targets. We remain excited about the potential of our target discovery platform, our drug development capabilities, and the strength of our teams, but we have to acknowledge that we experienced significant setbacks in recent quarters, and we drew important lessons from them. The discontinuation of the global Phase 3 program with ziritaxestat, announced earlier this year, in particular was a turning point. Halting this late-stage program in idiopathic pulmonary fibrosis (IPF) triggered a process of reassessment of our R&D efforts, and we consequently announced a number of portfolio decisions in our first quarter reporting, along with a significant cost-savings program. While not easy, we are convinced that it is crucial to right-size the organization for the Galapagos that we are today, in order to put us on the strongest footing for the future.
We continue to work hard on building our pipeline, and we recently announced positive topline data with GLPG3667, our proprietary selective TYK2 compound, in psoriasis (Pso). The clinical activity observed at 4 weeks for the high dose of GLPG3667 versus placebo in this Phase 1b trial, combined with the encouraging safety and tolerability profile, warrant further progression of GLPG3667. We currently are running a further dose escalation study in healthy volunteers, and we intend to launch a Phase 2b dose finding study in Pso as well as a Phase 2 study in ulcerative colitis (UC) with GLPG3667 in 2022.
Early Q3, we also announced the read-outs of the first patient studies with SIK2/3 inhibitor GLPG3970, pointing to the potential of SIK inhibition as a novel mode of action in inflammation. While the study in rheumatoid arthritis (RA; LADYBUG) did not give a signal, we observed clinical activity in Pso (CALOSOMA) as well as biologically important effects in ulcerative colitis (UC; SEA TURTLE) on a number of objective endpoints. GLPG3970 was generally safe and well tolerated across the three 6-week long trials. We are keen to draw learnings from our findings, including from additional biomarker data and analyses available later this year, as we work on optimizing the pharmacology of additional SIK compounds in our Toledo portfolio. We plan to bring an additional SIK2/3 molecule into a healthy volunteer Phase 1 study in 2022.
We are also proud of the progress achieved to date with our European commercial launch of filgotinib, under the brand name Jyseleca®. The transition from Gilead to us remains on track to be completed by year-end, and over the first half of 2021, we achieved a number of key milestones in gaining access and reimbursement. We are pleased to announce first sales of filgotinib in 11 countries. We are excited to bring our first commercial product to people suffering from RA, and we are looking forward to regulatory updates on the potential European approval of filgotinib in UC before year-end.
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Galapagos NV • H1 Report 2021
On the development side, we announced the start of our first large-scale real-world evidence program, the FILOSOPHY Phase 4 European outcomes study in RA. Earlier this year, we also presented encouraging exploratory data from the DIVERGENCE 2 study with filgotinib in fistulizing Crohn’s disease (CD), corroborating data from the DIVERGENCE 1 study in small bowel CD.
We also announced publication of the Phase 3 SELECTION full results with filgotinib in UC in The Lancet.
We continue to advance our refocused, differentiated portfolio of pipeline assets in our core areas of inflammation, fibrosis and kidney disease, as the below overview shows:
Operational overview Q1 2021
We refer to our Q1 2021 report.
Operational overview Q2 2021
In inflammation
| ● | Gilead submitted the new drug application in Japan for filgotinib for the treatment of UC in patients with an inadequate response to conventional therapies |
| ● | We reported encouraging exploratory data from the DIVERGENCE 2 trial with filgotinib in fistulizing CD |
| ● | We published the SELECTION Phase 3 data (Feagan et al. 2021) in The Lancet |
| ● | We presented 15 abstracts at EULAR (European League Against Rheumatism congress) in 2021, including new safety data analyses of 7 trials from the development program for filgotinib |
| ● | We initiated the FILOSOPHY Phase 4 study with filgotinib in RA |
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Galapagos NV • H1 Report 2021
Corporate & other
| ● | All annual general meeting (AGM) proposals were approved by shareholders at the AGM on April 28, 2021 |
| ● | We announced an extension of the lock-up period for Gilead’s current shares (currently 25.5%) in Galapagos to 2024 |
| ● | We received the second installment of €75 million from Gilead in Q2, following payment of an earlier installment of €35 million in January 2021, included under the revised filgotinib agreement as announced in December 2020 |
| ● | We created new subscription right plans, offering all Galapagos employees the opportunity to participate |
| ● | We raised €0.3 million from subscription right exercises |
| ● | We announced the planned departure of Piet Wigerinck, our Chief Scientific Officer, later this year |
Recent events
| ● | We observed activity with TYK2 inhibitor GLPG3667 in Pso, and recently launched a dose escalation study in healthy volunteers |
| ● | We reported on biological activity with SIK2/3 inhibitor GLPG3970 in inflammation |
H1 2021 financial result
Details of financial results
Due to the sale of our fee-for-service business (Fidelta) to Selvita on January 4, 2021 for a total consideration of €37.1 million (including customary adjustments for net cash and working capital), the results of Fidelta are presented as “Net income from discontinued operations” in our unaudited condensed consolidated income statement.
Revenues and other income from continuing operations
Our revenues and other income from continuing operations for the first six months of 2021 amounted to €277.2 million, compared to €217.2 million for the first six months of 2020.
Revenues amounted to €253.7 million for the first six months of 2021 compared to €194.4 million for the first six months of 2020, and were higher mainly driven by the increase in revenue recognition of upfront consideration and milestone payments received in the scope of the collaboration with Gilead for filgotinib amounting to €136.1 million for the first six months of 2021 (€75.0 million for the same period last year).
Other income (€23.6 million vs €22.8 million for the same period last year) increased, mainly driven by higher grant income.
Results from continuing operations
We realized a net loss from continuing operations of €77.2 million for the first six months of 2021, compared to a net loss of €169.2 million in the first six months of 2020.
We reported an operating loss amounting to €97.6 million for the first six months of 2021, compared to an operating loss of €134.4 million for the first six months of 2020.
Our R&D expenditure in the first six months of 2021 amounted to €268.8 million, compared to €262.9 million for the first six months of 2020. This increase, primarily related to our filgotinib program and our Toledo program, was compensated by a decrease for ziritaxestat, the OA program with GLPG1972, and the program in atopic dermatitis (AtD) with MOR106. Personnel costs increased due to an increase in headcount compared to the same period last year, and increased costs of our subscription right plans. This last factor, together with increased costs of the commercial launch of filgotinib in Europe, contributed to the increase in our G&A and S&M expenses, which were €106.0 million in the first six months of 2021, compared to €88.7 million in the first six months of 2020.
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Galapagos NV • H1 Report 2021
We reported a non-cash fair value gain from the re-measurement of initial warrant B issued to Gilead, amounting to €2.8 million, mainly due to the decreased implied volatility of the Galapagos share price as well as its evolution between December 31, 2020 and June 30, 2021.
Net other financial income in the first six months of 2021 amounted to €17.1 million, compared to net other financial loss of €13.0 million for the first six months of 2020, which was primarily attributable to €33.4 million of currency exchange gain on our cash and cash equivalents and current financial investments in U.S. dollars, to €8.7 million of negative changes in (fair) value of current financial investments and financial assets and to €4.4 million of interest charges. The other financial expenses also contained the effect of discounting our long term deferred income of €4.8 million.
Results from discontinued operations
The net income from discontinued operations for the six months ended June 30, 2021 consisted of the gain on the sale of Fidelta, our fee-for-services business, for €22.2 million.
Group net results
The group realized a net loss for the first six months of 2021 amounting to €55.0 million, compared to a net loss of €165.6 million for the same period in 2020.
Cash position
Current financial investments and cash and cash equivalents totaled €5,006.6 million on June 30, 2021 (€5,169.3 million on December 31, 2020, including the cash and cash equivalents included in the assets classified as held for sale).
Total net decrease in current financial investments and cash and cash equivalents amounted to €162.7 million in the first six months of 2021, compared to a net decrease of €214.3 million during the first six months of 2020. This net decrease was composed of (i) €223.2 million of operational cash burn1, offset by (ii) €2.6 million of cash proceeds from capital and share premium increase from exercise of subscription rights in the first six months of 2021, and (iii) €5.8 million of negative changes in (fair) value of current financial investments and €35.0 million of mainly positive exchange rate differences, (iv) €28.7 million cash in from the disposal of Fidelta, net of cash disposed.
Finally, our balance sheet as at June 30, 2021 held a receivable from the French government (Crédit d’Impôt Recherche2), and a receivable from the Belgian Government for R&D incentives for a total of €142.7 million.
Outlook 2021
Following the strategic exercise announced at Q1, we are focused on developing our resized pipeline and implementing our savings program, while executing on the successful commercial launch of Jyseleca and diligently evaluating business development opportunities.
In 2021, we expect the European regulatory assessment of filgotinib for the treatment of UC and anticipate both an opinion from CHMP and a decision from the European Commission later this year. We also expect additional reimbursement decisions for filgotinib in RA across a number of European countries. We are on track to complete the transition from our collaboration partner Gilead to us of the full European commercial operations for filgotinib by year-end, and we anticipate reporting on our own European sales of filgotinib starting in the second half of the year.
Completion of the recruitment in the global DIVERSITY Phase 3 trial with filgotinib in CD by our collaboration partner Gilead is also expected later this year.
With regard to our SIK portfolio, we are advancing our SIK3 inhibitor GLPG4399 in healthy volunteers this year, and we aim to advance a SIK2/3 preclinical candidate into the clinic in 2022.
Following the positive topline data from our TYK2 inhibitor, GLPG3667, we currently are running an extended dose escalation study in healthy volunteers, and we are preparing for a Phase 2b trial in Pso and a Phase 2 trial in UC next year.
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Galapagos NV • H1 Report 2021
In our other programs, by year-end we intend to finalize recruitment into the GLPG2737 Phase 2a trial in polycystic kidney disease.
Following the previously announced review of our plans for 2021, we reiterate our guidance for full year 2021 operational cash burn of €580 to €620 million.
We want to express our gratitude for your support and your patience, as we are working hard to rebuild the confidence in Galapagos.
Onno van de Stolpe
CEO
Bart Filius
President & COO
1 We refer to the note on the cash position of our condensed consolidated interim financial statements for an explanation and reconciliation of this alternative performance measure.
2 Crédit d’Impôt Recherche refers to an innovation incentive system underwritten by the French government.
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Galapagos NV • H1 Report 2021
COVID-19 impact
During the COVID-19 pandemic, we continue to innovate to accommodate for the current situation and minimize the impact to operations. We closely follow local governmental measures and apply these as appropriate within our organization, guided and supported by our dedicated COVID-19 task force teams. All local and global task force teams meet regularly and make recommendations directly to the COO.
We report the following impacts:
| ● | Staff We continue to follow the strict measures put in place to help prevent the spread of the virus and protect the health of our staff. We rolled out our global and site-specific business continuity plans and took appropriate recommended precautions. |
During lock-down periods, we arranged for essential tasks to be carried out within our facilities. Consequently, the majority of our Research staff continue working from the offices/labs, with periodic exceptions for local lockdowns during which no staff is allowed to come into the facilities. For those employees coming to the office, we have stringent cleaning and sanitation protocols in place, and we strictly respect social distancing policies at all times in order to minimize risk of exposure.
As the global pandemic continues into 2021, we aim to maintain our strict measures and protocols to ensure safety and good health of our employees. Strictly following the local governmental measures, we start to welcome back our employees on site.
| ● | Research portfolio By prioritizing the most advanced projects very early on, and increasing the flexibility of our staff in the labs within projects, we sustain our research progress, and continue our early drug research and the implementation of new modalities for target or drug discovery. So far, we note no material impact of the COVID-19 pandemic on our research portfolio. |
We have a business continuity plan for our clinical development programs. We closely monitor each program in the context of the current global and local situation of the pandemic and the associated specific regulatory, institutional, and government guidance and policies related to COVID-19. Within the boundaries of these guidances and policies, and in consultation with our CROs and clinical trial sites, we applied various measures to minimize the impact of the COVID-19 pandemic on our clinical development programs, with the primary aim to ensure the safety of our trial participants and to preserve the data integrity and scientific validity of the trials. These measures continue to be implemented on a case-by-case basis, tailored to the specific study and country needs at any given time, with specific attention paid to vulnerable populations and the use of investigational medicines with immunosuppressive properties. The measures include, among others, increased, transparent communication to all stakeholders and the direct supply of investigational medicines to patients. For each clinical trial, we actively monitor and document the impact of COVID-19 on the study where necessary and facilitate the interpretation and reporting of results.
Following the global increase of COVID-19 testing and vaccinations, we issued an internal guidance on the impact of testing and vaccinations on clinical trials.
As of publication of this H1 report, our collaboration partner Gilead has not been informed by regulatory agencies of approval timeline delays related to the pandemic.
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Galapagos NV • H1 Report 2021
To date, there has been no COVID-19 impact to the commercial supply of filgotinib. Gilead also confirmed that all sites involved in the manufacturing of filgotinib are established sites that currently manufacture other Gilead marketed products and are in good standing with the FDA and are GMP certified. Under the revised agreement with Gilead for filgotinib in Europe, Galapagos plans to become the marketing authorization holder of filgotinib in Europe by year-end 2021, and then become responsible for manufacturing. We will work with the same manufacturing sites as Gilead except for secondary packaging and labelling for which a new vendor has been selected.
The form of outreach of our commercial teams to physicians and hospitals was impacted by the COVID-19 pandemic and consequent travel restrictions, and thus became partially virtual. The teams invested in digital channels as part of the overall commercial build strategy, and these channels are being utilized during our ongoing commercial launch. Thus far we note no material impact on our commercial operations due to travel restrictions, nor has there been an impact of COVID-19 on our ability to engage in market access discussions. Nevertheless, healthcare systems are under pressure across Europe, increasing the risk of future volatility in reimbursement procedures and potentially reducing the number of new therapy options initiated by healthcare providers.
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Galapagos NV • H1 Report 2021
At a glance
Key figures (IFRS) Galapagos group (unaudited)
(Euro in thousands, if not stated otherwise) | | | | | | | | | |
INCOME STATEMENT (*) | Second quarter of 2021 | | Second quarter of 2020 |
| Six months ended June 30, 2021 | | Six months ended June 30, 2020 |
| Full year 2020 |
Revenues | 139,772 | | 99,587 | | 253,664 | | 194,404 | | 478,053 |
Other income | 13,298 | | 14,059 | | 23,564 | | 22,802 | | 52,207 |
R&D expenditure | (138,866) | | (147,448) | | (268,826) | | (262,901) | | (523,667) |
S, G&A expenses | (60,954) | | (54,371) | | (105,950) | | (88,696) | | (185,225) |
Operating expenses | (199,820) | | (201,819) | | (374,776) | | (351,597) | | (708,892) |
Operating loss | (46,750) | | (88,173) | | (97,548) | | (134,391) | | (178,632) |
Net financial results | (18,209) | | (28,439) | | 19,916 | | (34,144) | | (131,143) |
Taxes | 630 | | (373) | | 473 | | (709) | | (1,226) |
Net loss from continuing operations | (64,329) | | (116,986) | | (77,159) | | (169,244) | | (311,001) |
Net income from discontinued operations, net of tax | - | | 1,944 | | 22,191 | | 3,601 | | 5,565 |
Net loss | (64,329) | | (115,042) | | (54,968) | | (165,643) | | (305,436) |
| | | | | | | | | |
BALANCE SHEET | | | | | | | | | |
Cash and cash equivalents | 2,642,639 | | 2,384,220 | | 2,642,639 | | 2,384,220 | | 2,135,187 |
Current financial investments | 2,363,969 | | 3,182,276 | | 2,363,969 | | 3,182,276 | | 3,026,278 |
R&D incentives receivables | 142,745 | | 116,629 | | 142,745 | | 116,629 | | 135,728 |
Assets | 5,430,617 | | 5,851,564 | | 5,430,617 | | 5,851,564 | | 5,717,731 |
Shareholders' equity | 2,663,473 | | 2,773,263 | | 2,663,473 | | 2,773,263 | | 2,670,355 |
Deferred income | 2,565,292 | | 2,823,833 | | 2,565,292 | | 2,823,833 | | 2,809,133 |
Other liabilities | 201,852 | | 254,468 | | 201,852 | | 254,468 | | 238,242 |
| | | | | | | | | |
CASH FLOW | | | | | | | | | |
Operational cash burn (**) | (95,527) | | (147,088) | | (223,196) | | (230,486) | | (517,404) |
Cash flow used in operating activities | (81,922) | | (140,955) | | (203,131) | | (209,829) | | (427,336) |
Cash flow generated from/used in (-) investing activities | 182,194 | | (216,836) | | 682,053 | | 712,804 | | 757,288 |
Cash flow generated from/used in (-) financing activities | (1,952) | | 16,316 | | (1,474) | | 20,246 | | 22,040 |
Increase/decrease(-) in cash and cash equivalents | 98,319 | | (341,474) | | 477,448 | | 523,222 | | 351,994 |
Effect of currency exchange rate fluctuation on cash and cash equivalents | (9,629) | | (17,878) | | 22,121 | | (617) | | (70,539) |
Cash and cash equivalents at the end of the period | 2,642,639 | | 2,384,220 | | 2,642,639 | | 2,384,220 | | 2,143,071 |
| | | | | - | | | | |
Cash and cash equivalents from continuing operations | 2,642,639 | | 2,384,220 | | 2,642,639 | | 2,384,220 | | 2,135,187 |
Cash and cash equivalents classified as assets held for sale | - | | - | | - | | - | | 7,884 |
Current financial investments at the end of the period | 2,363,969 | | 3,182,276 | | 2,363,969 | | 3,182,276 | | 3,026,278 |
Total current financial investments and cash and cash equivalents at the end of the period | 5,006,608 | | 5,566,496 | | 5,006,608 | | 5,566,496 | | 5,169,349 |
| | | | | | | | | |
FINANCIAL RATIOS | | | | | | | | | |
Number of shares issued at the end of the period | 65,522,521 | | 65,254,562 | | 65,522,521 | | 65,254,562 | | 65,411,767 |
Basic & diluted loss per share (in Euro) | (0.98) | | (1.77) | | (0.84) | | (2.55) | | (4.69) |
Share price at the end of the period (in Euro) | 58.48 | | 175.05 | | 58.48 | | 175.05 | | 80.48 |
Total group employees at the end of the period (number)(***) | 1,397 | | 1,280 | | 1,397 | | 1,280 | | 1,489 |
(*) The comparatives of June 30, 2020 and the second quarter of 2020 have been restated to consider the impact of classifying the Fidelta business as discontinued operations in 2020.
(*)We refer to the note on our cash position of our condensed consolidated interim financial statements for an explanation and reconciliation of this alternative performance measure.
(***) The number of employees on December 31, 2020 and on June 30, 2020 included respectively 185 and 168 employees of Fidelta, which has been sold to Selvita on January 4, 2021.
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Galapagos NV • H1 Report 2021
Risk factors
We refer to the description of risk factors in the 2020 annual report, pp. 51-61, as supplemented by the description of risk factors in our annual report on Form 20-F filed with the U.S. Securities and Exchange Commission, pp. 8-48. In summary, the principal risks and uncertainties faced by us relate to: commercialization, product development and regulatory approval; our financial position and need for additional capital; our reliance on third parties; our competitive position; our intellectual property; our organization, structure and operation (including the emergence of epidemics such as COVID-19); and market risks relating to our shares and ADSs.
We also refer to the description of the group’s financial risk management given in the 2020 annual report, pp. 193-196, which remains valid.
The Galapagos share
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Galapagos NV • H1 Report 2021
Related party transactions
We refer to the statements included under the heading “Related party transactions” in the “Notes to the unaudited condensed consolidated interim financial statements for the first six months of 2021” part of this report.
Disclaimer and other information
Galapagos NV is a limited liability company organized under the laws of Belgium, having 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.
With the exception of filgotinib’s approval for the treatment of rheumatoid arthritis by the European Commission, Great Britain’s Medicines and Healthcare Products Regulatory Agency and Japanese Ministry of Health, Labour and Welfare, our drug candidates mentioned in this report are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.
This report is published in Dutch and in English. In case of inconsistency between the Dutch and the English versions, the Dutch version shall prevail. Galapagos is responsible for the translation and conformity between the Dutch and English version.
This report is available free of charge and upon request addressed to:
Galapagos NV
Investor Relations
Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium
Tel: +32 15 34 29 00
Email: ir@glpg.com
A digital version of this report 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.
Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.
Listings
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Galapagos NV • H1 Report 2021
Forward-looking statements
This report 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,” “estimate,” “may,” “will,” “could,” “stand to,” “continue,” as well as similar expressions. Forward-looking statements contained in this report include, but are not limited to, statements made in the “Letter from the management”, the information provided in the section captioned “Outlook 2021”, guidance from management regarding the expected operational use of cash during financial year 2021, statements regarding the amount and timing of potential future milestones, opt-in and/or royalty payments by Gilead, Galapagos’ strategic R&D ambitions, including progress on our fibrosis portfolio and our Toledo platform, and potential changes of such ambitions, statements regarding the strategic re-evaluation, our statements and expectations regarding commercial sales of filgotinib, statements regarding the global R&D collaboration with Gilead and regarding the amendment of our arrangement with Gilead for the commercialization and development of filgotinib, statements regarding the expected timing, design and readouts of ongoing and planned clinical trials (i) with filgotinib in rheumatoid arthritis, ulcerative colitis and Crohn’s disease, (ii) with GLPG4716 in IPF, (iii) with GLPG3970 in ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus and primary Sjögren’s syndrome, (iv) with GLPG0555 in osteoarthritis, (v) with GLPG4399 and GLPG4876 in inflammation, (vi) with GLPG3667 in psoriasis, (vii) with GLPG2737 in PCKD, (viii) with GLPG3121 in IBD, and (ix) with GLPG4586 and GLPG4605 in fibrosis, 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, including the UC and IBD indications for filgotinib in Europe, Great Britain, Japan, and the U.S., such additional regulatory authorities requiring additional studies, the timing or likelihood of pricing and reimbursement interactions for filgotinib, statements relating to the build-up of our commercial organization and commercial sales for filgotinib, the expected impact of COVID-19, and our strategy, business plans and focus. We caution the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements may involve 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. In addition, even if our results of operations, 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. Among the factors that may result in differences are that our expectations regarding our 2021 revenues and financial results and our 2021 operating expenses may be incorrect (including because one or more of our assumptions underlying our revenue or expense expectations may not be realized), the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from our clinical research programs in rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, idiopathic pulmonary fibrosis, systemic sclerosis, osteoarthritis, other inflammatory indications and kidney diseases may not support registration or further development of our product candidates due to safety, efficacy or other reasons), our reliance on collaborations with third parties (including our collaboration partner, Gilead), estimations regarding our filgotinib development program and the commercial potential of our product candidates and Galapagos’ expectations regarding the costs and revenues associated with the transfer of European commercialization rights to filgotinib may be incorrect, 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 our Securities and Exchange Commission filing and reports, 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. 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.
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Galapagos NV • H1 Report 2021
UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
Consolidated statements of income and comprehensive income/loss (-)
(unaudited)
Consolidated income statement
| Second quarter of | | | Six months ended June 30, | ||||||||
| 2021 |
| 2020 (*) | |
| 2021 |
| 2020 (*) | ||||
| (Euro, in thousands, except per share data) | | | (Euro, in thousands, except per share data) | ||||||||
Revenues | € | | | € | | | | € | | | € | |
Other income | | | | | | | | | | | | |
Total revenues and other income | | | | | | | | | | | | |
| | | | | | | | | | | | |
Research and development expenditure | | ( | | | ( | | | | ( | | | ( |
Sales and marketing expenses | | ( | | | ( | | | | ( | | | ( |
General and administrative expenses | | ( | | | ( | | | | ( | | | ( |
Total operating expenses | | ( | | | ( | | | | ( | | | ( |
| | | | | | | | | | | | |
Operating loss | | ( | | | ( | | | | ( | | | ( |
| | | | | | | | | | | | |
Fair value re-measurement of warrants | | | | | ( | | | | | | | ( |
Other financial income | | ( | | | ( | | | | | | | |
Other financial expenses | | ( | | | ( | | | | ( | | | ( |
| | | | | | | | | | | | |
Loss before tax | | ( | | | ( | | | | ( | | | ( |
| | | | | | | | | | | | |
Income taxes | | | | | ( | | | | | | | ( |
| | | | | | | | | | | | |
Net loss from continuing operations | | ( | | | ( | | | | ( | | | ( |
| | | | | | | | | | | | |
Net income from discontinued operations, net of tax | | | | | | | | | | | | |
| | | | | | | | | | | | |
Net loss | € | ( | | € | ( | | | € | ( | | € | ( |
Net loss attributable to: | | | | | | | | | | | | |
Owners of the parent | € | ( | | € | ( | | | € | ( | | € | ( |
Basic and diluted loss per share | € | ( | | € | ( | | | € | ( | | € | ( |
Basic and diluted loss per share from continuing operations | € | ( | | € | ( | | | € | ( | | € | ( |
(*) The comparatives of June 30, 2020 and the second quarter of 2020 have been restated to consider the impact of classifying the Fidelta business as discontinued operations in 2020. |
The accompanying notes form an integral part of these condensed consolidated financial statements.
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Galapagos NV • H1 Report 2021
Consolidated statement of comprehensive income / loss (-)
| Second quarter of | | | Six months ended June 30, | ||||||||
| 2021 |
| 2020 (*) | |
| 2021 |
| 2020 (*) | ||||
| (Euro, in thousands) | | | (Euro, in thousands) | ||||||||
| | | | | | | | | | | | |
Net loss | € | ( | | € | ( | | | € | ( | | € | ( |
Items that may be reclassified subsequently to profit or loss: | | | | | | | | | | | | |
Translation differences, arisen from translating foreign activities | | ( | | | ( | | | | | | | |
| | | | | | | | | | | | |
Realization of translation differences upon sale of foreign operations | | | | | | | | | | | | |
Other comprehensive income/loss (-), net of income tax | | ( | | | ( | | | | | | | |
| | | | | | | | | | | | |
Total comprehensive loss attributable to: | | | | | | | | | | | | |
Owners of the parent | € | ( | | € | ( | | | € | ( | | € | ( |
| | | | | | | | | | | | |
Total comprehensive loss attributable to owners of the parent arises from: | | | | | | | | | | | | |
Continuing operations | | ( | | | ( | | | | ( | | | ( |
Discontinued operations | | | | | | | | | | | | |
Total comprehensive loss | € | ( | | € | ( | | | € | ( | | € | ( |
(*) The comparatives of June 30, 2020 and the second quarter of 2020 have been restated to consider the impact of classifying the Fidelta business as discontinued operations in 2020.
The accompanying notes form an integral part of these condensed consolidated financial statements.
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Galapagos NV • H1 Report 2021
Consolidated statement of financial position
(unaudited)
| | | June 30, | | December 31, | ||
|
| | 2021 |
| 2020 | ||
| | | (Euro, in thousands) | ||||
Assets | | | | | | | |
Intangible assets | | | € | | | € | |
Property, plant and equipment | | | | | | | |
Deferred tax assets | | | | | | | |
Non-current trade receivables | | | | | | | |
Non-current R&D incentives receivables | | | | | | | |
Other non-current assets | | | | | | | |
Non-current assets | | | | | | | |
| | | | | | | |
Trade and other receivables | | | | | | | |
Current R&D incentives receivables | | | | | | | |
Current financial investments | | | | | | | |
Cash and cash equivalents | | | | | | | |
Other current assets | | | | | | | |
Current assets from continuing operations | | | | | | | |
| | | | | | | |
Assets classified as held for sale | | | | | | | |
| | | | | | | |
Total current assets | | | | | | | |
| | | | | | | |
Total assets | | | € | | | € | |
| | | | | | | |
Equity and liabilities | | | | | | | |
| | | | | | | |
Share capital | | | € | | | € | |
Share premium account | | | | | | | |
Other reserves | | | | ( | | | ( |
Translation differences | | | | ( | | | ( |
Accumulated losses | | | | ( | | | ( |
Total equity | | | | | | | |
| | | | | | | |
Retirement benefit liabilities | | | | | | | |
Non-current lease liabilities | | | | | | | |
Other non-current liabilities | | | | | | | |
Non-current deferred income | | | | | | | |
Non-current liabilities | | | | | | | |
| | | | | | | |
Current lease liabilities | | | | | | | |
Trade and other liabilities | | | | | | | |
Current tax payable | | | | | | | |
Current financial instruments | | | | | | | |
Current deferred income | | | | | | | |
Current liabilities from continuing operations | | | | | | | |
| | | | | | | |
Liabilities directly associated with assets classified as held for sale | | | | | | | |
| | | | | | | |
Total current liabilities | | | | | | | |
| | | | | | | |
Total liabilities | | | | | | | |
Total equity and liabilities | | | € | | | € | |
The accompanying notes form an integral part of these condensed consolidated financial statements.
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Galapagos NV • H1 Report 2021
Consolidated cash flow statement
(unaudited)
| | Six months ended June 30, | | |||||
|
| 2021 |
| 2020 |
| |||
| | (Euro, in thousands) | | |||||
| | | | | | | | |
Net loss of the period | | € | ( | | | € | ( | |
| | | | | | | | |
Adjustment for non-cash transactions | | | | | | | | |
Adjustment for items to disclose separately under operating cash flow | | | | | | | ( | |
Adjustment for items to disclose under investing and financing cash flows | | | ( | | | | ( | |
Change in working capital other than deferred income | | | | | | | | |
Decrease in deferred income | | | ( | | | | ( | |
| | | | | | | | |
Cash used in operations | | | ( | | | | ( | |
| | | | | | | | |
Interest paid | | | ( | | | | ( | |
Interest received | | | | | | | | |
Corporate taxes paid | | | ( | | | | ( | |
| | | | | | | | |
Net cash flows used in operating activities | | | ( | | | | ( | |
| | | | | | | | |
Purchase of property, plant and equipment | | | ( | | | | ( | |
Purchase of intangible fixed assets | | | ( | | | | ( | |
Proceeds from disposal of property, plant and equipment | | | | | | | | |
Purchase of current financial investments | | | ( | | | | ( | |
Interest received related to current financial investments | | | | | | | | |
Sale of current financial investments | | | | | | | | |
Cash in from disposal of subsidiaries, net of cash disposed of | | | | | | | | |
Acquisition of financial assets | | | | | | | ( | |
Proceeds from sale of financial assets held at fair value through profit or loss | | | | | | | | |
| | | | | | | | |
Net cash flows generated from investing activities | | | | | | | | |
| | | | | | | | |
Payment of lease liabilities | | | ( | | | | ( | |
Proceeds from capital and share premium increases from exercise of subscription rights | | | | | | | | |
| | | | | | | | |
Net cash flows generated from/used in (-) financing activities | | | ( | | | | | |
| | | | | | | | |
Increase in cash and cash equivalents | | | | | | | | |
| | | | | | | | |
| | | | | | | | |
Cash and cash equivalents at beginning of the period | | | | | | | | |
| | | | | | | | |
Increase in cash and cash equivalents | | | | | | | | |
| | | | | | | | |
Effect of exchange rate differences on cash and cash equivalents | | | | | | | ( | |
| | | | | | | | |
Cash and cash equivalents at end of the period | | € | | | | € | | |
The accompanying notes form an integral part of these condensed consolidated financial statements.
| | June 30, | |||||
| | 2021 |
| | 2020 | ||
| | (Euro, in thousands) | |||||
Current financial investments | | € | | | | € | |
Cash and cash equivalents | | | | | | | |
Current financial investments and cash and cash equivalents | | € | | | | € | |
The accompanying notes form an integral part of these condensed consolidated financial statements.
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Galapagos NV • H1 Report 2021
Consolidated statements of changes in equity
(unaudited)
|
| Share |
| Share |
| Translation |
| Other |
| Accumulated |
| Total | ||||||
| | (Euro, in thousands) | ||||||||||||||||
On January 1, 2020 | | € | | | € | | | € | ( | | € | ( | | € | ( | | € | |
Net loss | | | | | | | | | | | | | | | ( | | | ( |
Other comprehensive income/loss (-) | | | | | | | | | | | | ( | | | | | | |
Total comprehensive income / loss (-) | | | | | | | | | | | | ( | | | ( | | | ( |
Share-based compensation | | | | | | | | | | | | | | | | | | |
Exercise of subscription rights | | | | | | | | | | | | | | | | | | |
On June 30, 2020 | | € | | | € | | | € | ( | | € | ( | | € | ( | | € | |
| | | | | | | | | | | | | | | | | | |
On January 1, 2021 | | € | | | € | | | € | ( | | € | ( | | € | ( | | € | |
Net loss | | | | | | | | | | | | | | | ( | | | ( |
Other comprehensive income | | | | | | | | | | | | | | | | | | |
Total comprehensive income / loss (-) | | | | | | | | | | | | | | | ( | | | ( |
Share-based compensation | | | | | | | | | | | | | | | | | | |
Exercise of subscription rights | | | | | | | | | | | | | | | | | | |
On June 30, 2021 | | € | | | € | | | € | ( | | € | ( | | € | ( | | € | |
The accompanying notes form an integral part of these condensed consolidated financial statements.
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Galapagos NV • H1 Report 2021
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS FOR THE FIRST SIX MONTHS OF 2021
Basis of preparation
These condensed consolidated interim financial statements have been prepared in accordance with IAS 34 ‘Interim Financial Reporting’ as adopted by the European Union and as issued by the IASB. The condensed consolidated interim financial statements do not contain all information required for an annual report and should therefore be read in conjunction with our annual report 2020.
Impact of COVID-19 on the financial statements
To date we have experienced limited impact on our financial performance, financial position, cash flows and significant judgements and estimates, although we continue to face additional risks and challenges associated with the impact of the outbreak.
Significant accounting policies
There were no significant changes in accounting policies applied by us in these condensed consolidated interim financial statements compared to those used in the most recent annual consolidated financial statements of December 31, 2020.
New standards and interpretations applicable for the annual period beginning on January 1, 2021 did not have any impact on our condensed consolidated interim financial statements.
We have not early adopted any other standard, interpretation, or amendment that has been issued but is not yet effective.
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Galapagos NV • H1 Report 2021
DETAILS OF THE UNAUDITED CONDENSED CONSOLIDATED INTERIM RESULTS
Revenues and other income
Revenues
The following table summarizes our revenues for the six months ended June 30, 2021 and 2020.
| | | | Six months ended June 30, | ||||
| | Over time | Point in time | 2021 |
| 2020 | ||
| | | | (Euro, in thousands) | ||||
Recognition of non-refundable upfront payments and license fees | | | | € | | | € | |
Gilead collaboration agreement for filgotinib | Ö | | | | | | | |
Gilead collaboration agreement for drug discovery platform | Ö | | | | | | | |
Milestone payments | | | | | | | | |
Gilead collaboration agreement for filgotinib | Ö | | | | | | | |
Reimbursement income | | | | | — | | | |
Novartis collaboration agreement for MOR106 | Ö | | | — | | | | |
AbbVie collaboration agreement for CF | Ö | | | — | | | ( | |
Other revenues | | | | | | | | |
Other revenues | | Ö | | | | | | |
Commercial revenues | | | | | | | — | |
Sale of goods | | Ö | | | | | — | |
Royalties | | Ö | | | | | — | |
Other commercial revenues | | Ö | | | | | — | |
Total revenues | | | | € | | | € | |
Revenues (€
The rollforward of the outstanding balance of the current and non-current deferred income between January 1, 2021 and June 30, 2021 can be summarized as follows:
| | | Total | | | Gilead collaboration agreement for filgotinib | | | Gilead collaboration agreement for drug discovery platform (1) | | | Other deferred income (grants) |
| | | (Euro, in thousands) | |||||||||
| | | | | | | | | | | | |
On January 1, 2021 | | € | | | € | | | € | | | € | |
| | | | | | | | | | | | |
Significant financing component (2) | | | | | | | | | | | | |
| | | | | | | | | | | | |
Revenue recognition of upfront | | | ( | | | ( | | | ( | | | |
Revenue recognition of milestones | | | ( | | | ( | | | | | | |
| | | | | | | | | | | | |
Other movements | | | | | | | | | | | | |
| | | | | | | | | | | | |
On June 30, 2021 | | € | | | € | | | € | | | € | |
| (1) | The outstanding balance at January 1, 2021 and June 30, 2021 comprise the issuance liability for subsequent warrant B and the upfront payment allocated to the drug discovery platform. |
| (2) | With regard to the additional consideration received for the extended cost sharing for filgotinib, we assume the existence of a significant financing component reflecting the time value of money on the estimated recognition period. |
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Galapagos NV • H1 Report 2021
Other income
Other income (€
Results from continuing operations
We realized a net loss from continuing operations of €
We reported an operating loss amounting to €
Our R&D expenditure in the first six months of 2021 amounted to €
The table below summarizes our R&D expenditure for the six months ended June 30, 2021 and 2020, broken down by program.
| | Six months ended June 30, | ||||
| | 2021 | | 2020 | ||
| | (Euro, in thousands) | ||||
Filgotinib program | | € | ( | | € | ( |
Ziritaxestat program | | | ( | | | ( |
OA program with GLPG1972 | | | ( | | | ( |
Toledo program | | | ( | | | ( |
AtD program with MOR106 | | | ( | | | ( |
Other programs | | | ( | | | ( |
Total R&D expenditure | | € | ( | | € | ( |
Our G&A and S&M expenses were €
In the first six months of 2021 we reported a non-cash fair value gain from the re-measurement of initial warrant B issued to Gilead, amounting to €
Net other financial income in the first six months of 2021 amounted to €
Cash position
Cash and cash equivalents and current financial investments totaled €
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Galapagos NV • H1 Report 2021
A net decrease of €
The operational cash burn (or operational cash flow if this performance measure is positive) is a financial measure that is not calculated in accordance with IFRS. Operational cash burn/ cash flow is defined as the increase or decrease in our cash and cash equivalents (excluding the effect of exchange rate differences on cash and cash equivalents), minus:
i.the net proceeds, if any, from share capital and share premium increases included in the net cash flows generated from/used in (–) financing activities
ii.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, included in the net cash flows generated from/ used in (–) investing activities.
This alternative performance measure is in our view an important metric for a biotech company in the development stage.
The following table represents a reconciliation of the operational cash burn:
| | Six months ended June 30, | ||||
| | 2021 | | 2020 | ||
| | (Euro, in thousands) | ||||
Increase in cash and cash equivalents (excluding effect of exchange differences) | | € | | | € | |
Minus: | | | | | | |
Net proceeds from capital and share premium increases | | | ( | | | ( |
Net sale of current financial investments | | | ( | | | ( |
Cash in from disposal of subsidiaries, net of cash disposed of | | | ( | | | — |
Total operational cash burn | | | ( | | € | ( |
Cash and cash equivalents and current financial investments comprised cash at banks, short-term bank deposits, treasury bills and money market funds that are readily convertible to cash and are subject to an insignificant risk of changes in value. Our cash management strategy monitors and optimizes our liquidity position. Our cash management strategy allows short term deposits with an original maturity exceeding
Cash invested in highly liquid money market funds represented €
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Galapagos NV • H1 Report 2021
| | June 30, | | December 31, | ||
|
| 2021 |
| 2020 | ||
| | (Euro, in thousands) | ||||
Cash at banks | | € | | | € | |
Term deposits | | | | | | |
Total cash and cash equivalents from continuing operations | | | | | | |
Cash and cash equivalents included in assets classified as held for sale | | | — | | | |
Total cash and cash equivalents | | € | | | € | |
On June 30, 2021, our cash and cash equivalents and current financial investments included $
Finally, our balance sheet held R&D incentives receivables from the French government (Crédit d’Impôt Recherche), to be received in
Capital increase
On June 30, 2021, Galapagos NV’s share capital was represented by
(Euro, in thousands, except share data) |
| Number of shares |
| Share |
| Share |
| | Share capital | | | Average exercise price subscription rights | | | Closing share price on date of capital increase | |||
| | | | | | | | | | | | | | | ( in Euro/ subscription right) | | | ( in Euro/ share) |
On January 1, 2021 | | | | | € | | | € | | | € | | | | | | | |
| | | | | | | | | | | | | | | | | | |
March 19, 2021 : exercise of subscription rights | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
June 7, 2021 : exercise of subscription rights | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
On June 30, 2021 | | | | | € | | | € | | | € | | | | | | | |
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Galapagos NV • H1 Report 2021
Note the cash flow statement
| | Six months ended June 30, | | |||||
| | 2021 |
| 2020 | | |||
| | (Euro, in thousands) | | |||||
Adjustment for non-cash transactions | | | | | | | | |
Depreciations, amortizations and impairment | | € | | | | € | | |
Share-based compensation expenses | | | | | | | | |
Increase in retirement benefit liabilities and provisions | | | | | | | | |
Unrealized exchange results and non-cash other financial expenses | | | ( | | | | ( | |
Discounting effect of deferred income | | | | | | | | |
Fair value re-measurement of warrants | | | ( | | | | | |
Net change in (fair) value of current financial investments | | | | | | | | |
Fair value adjustment financial assets held at fair value through profit or loss | | | | | | | | |
Other non-cash costs | | | | | | | | |
Total adjustment for non-cash transactions | | | | | | | | |
| | | | | | | | |
| | | | | | | | |
Adjustment for items to disclose separately under operating cash flow | | | | | | | | |
Interest expense | | | | | | | | |
Interest income | | | ( | | | | ( | |
Tax income (-)/tax expense | | | ( | | | | | |
Total adjustment for items to disclose separately under operating cash flow | | | | | | | ( | |
| | | | | | | | |
| | | | | | | | |
Adjustment for items to disclose under investing and financing cash flows | | | | | | | | |
Gain on sale of subsidiaries | | | ( | | | | — | |
Loss on sale of fixed assets | | | | | | | | |
Realized exchange gain on sale of current financial investments | | | ( | | | | — | |
Interest income related to current financial investments | | | ( | | | | ( | |
Total adjustment for items to disclose under investing and financing cash flows | | | ( | | | | ( | |
| | | | | | | | |
| | | | | | | | |
Change in working capital other than deferred income | | | | | | | | |
Increase in inventories | | | ( | | | | ( | |
Decrease in receivables | | | | | | | | |
Increase/decrease (-) in payables | | | ( | | | | | |
Total change in working capital other than deferred income | | € | | | | € | | |
gg
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Galapagos NV • H1 Report 2021
Discontinued operations
The following disclosure illustrates the result of our discontinued operations, related to the sale of our fee-for-service business (Fidelta) to Selvita on January 4, 2021.
| 1. | Disposal of subsidiaries (discontinued operations) |
| 1.1 | Consideration received |
| (Euro, in thousands) | ||
Consideration received in cash and cash equivalents | € | | |
Total consideration received | € | | |
| 1.2 | Analysis of assets and liabilities over which control was lost |
| January 4, 2021 | | |
| (Euro, in thousands) | ||
Intangible assets | € | | |
Property, plant and equipment | | | |
Other non-current assets | | | |
Trade and other receivables | | | |
Cash and cash equivalents | | | |
Other current assets | | | |
Total assets | | | |
| | | |
Non-current lease liabilities | | | |
Other non-current liabilities | | | |
Trade and other liabilities | | | |
Current lease liabilities | | | |
Income tax payable | | | |
Total liabilities | | | |
| | | |
Net assets disposed of | € | | |
| 1.3 | Gain on disposal of subsidiaries |
| (Euro, in thousands) | ||
Consideration received | € | | |
Net assets disposed of | | ( | |
Effect of cumulative translation adjustments reclassified from equity on loss of control | | ( | |
Costs associated to the sale | | ( | |
Gain on disposal | € | | |
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Galapagos NV • H1 Report 2021
| 1.4 | Net cash inflow on disposal of subsidiaries |
| (Euro, in thousands) | ||
Consideration received in cash and cash equivalents | € | | |
Less: cash and cash equivalents balances disposed of | | ( | |
Total consideration received, net of cash disposed of | | | |
Costs associated to the sale | | ( | |
Cash in from disposal of subsidiaries, net of cash disposed of | € | | |
| 2. | Result from discontinued operations |
| Six months ended June 30, | ||||
| 2021 |
| 2020 | ||
| (Euro, in thousands, except share and per share data) | ||||
Revenues | € | — | | € | |
Other income | | — | | | — |
Total revenues and other income | | — | | | |
| | | | | |
Gain on disposal of subsidiaries | | | | | — |
| | | | | |
Research and development expenditure | | — | | | ( |
Sales and marketing expenses | | — | | | — |
General and administrative expenses | | — | | | ( |
Total operating expenses | | — | | | ( |
| | | | | |
Operating income | | | | | |
| | | | | |
Other financial income | | — | | | |
Other financial expenses | | — | | | ( |
| | | | | |
Income before tax | | | | | |
| | | | | |
Income taxes | | — | | | — |
| | | | | |
Net income | € | | | € | |
| | | | | |
Basic income per share | € | | | € | |
Diluted income per share | € | | | € | |
Weighted average number of shares - Basic (in '000 shares) | | | | | |
Weighted average number of shares - Diluted (in '000 shares) | | | | | |
| 3. | Cash flows from discontinued operations |
| Six months ended June 30, | ||||
| 2021 |
| 2020 | ||
| (Euro, in thousands) | ||||
Net cash flows generated from operating activities | € | — | | € | |
Net cash flows generated from/used in (-) investing activities | | | | | ( |
Net cash flows used in financing activities | | — | | | ( |
Net cash flows from discontinued operations | € | | | € | |
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Galapagos NV • H1 Report 2021
Contingencies and commitments
Contractual obligations and commitments
We have certain purchase commitments principally with CRO subcontractors and certain collaboration partners.
On June 30, 2021 we had outstanding obligations for purchase commitments, which become due as follows:
|
| Total |
| Less than |
| 1 - 3 |
| 3 - 5 |
| More than 5 | |||||
| | | (Euro, in thousands) | ||||||||||||
Purchase commitments | | € | | | € | | | € | | | € | | | € | |
In addition to the table above, we have a contractual cost sharing obligation related to our collaboration agreement with Gilead for filgotinib. The contractual cost sharing commitment amounted to €
Contingent liabilities and assets
We refer to our annual report 2020 for a description of our contingent liabilities and assets.
Related party transactions
On April 30, 2021, the members of the management board were offered new subscription rights under Subscription Right Plan 2021 BE, subject to acceptance. A first portion of the number of accepted subscription rights under Subscription Right Plan 2021 BE and the final number of accepted subscription rights under Subscription Right Plan 2021 RMV and Subscription Right Plan 2021 ROW were enacted by notary deed on July 2, 2021. For
On May 5, 2021, the members of the management board were offered new restricted stock units (‘RSUs’), subject to acceptance. The RSUs are offered for
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Galapagos NV • H1 Report 2021
The table below sets forth the number of subscription rights offered under Subscription Right Plan 2021 BE and the total number of RSUs accepted by each member of the management board during the first six months of 2021:
Name | | Title | | Number of 2021 subscription rights offered | Number of 2021 RSUs accepted | |
Onno van de Stolpe | | Chief Executive Officer | | | | |
Bart Filius | | President & Chief Operating Officer | | | | |
Walid Abi-Saab | | Chief Medical Officer | | | | |
Piet Wigerinck | | Chief Scientific Officer | | | | - |
Andre Hoekema | | Chief Business Officer | | | | - |
Michele Manto | | Chief Commercial Officer | | | | |
We note that Dr. Rajesh Parekh and Ms. Katrine Bosley were re-appointed as members of the supervisory board by the shareholders’ meeting of April 28, 2021 for a period of
During the first six months of 2021, there were no changes to related party transactions disclosed in the 2020 annual report that potentially had a material impact on the financials of the first six months of 2021.
Events after the end of the reporting period
There were no adjusting events nor material non-adjusting events to be reported.
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Galapagos NV • H1 Report 2021
GLOSSARY OF TERMS
Glossary of terms, to be read only in conjunction with this H1 Report 2021.
100 points clinical response
Percentage of patients achieving a 100-point decrease in CDAI score during a clinical trial in CD patients
ACR
American College of Rheumatology
ACR20 (ACR 20/50/70)
American College of Rheumatology 20% response rate signifies a 20% or greater improvement in the number of swollen and tender joints as well as a 20% or greater improvement in three out of five other disease-activity measures. ACR50 and ACR70 reflect the same, for 50% and 70% response rates, respectively
Adenovirus
A common virus that causes cold-like symptoms and is used as a research tool for the lab in the discovery of new drugs
ADPKD
Autosomal dominant polycystic kidney disease, a disease where typically both kidneys become enlarged with fluid-filled cysts, leading to kidney failure. Other organs may be affected as well
ADS
American Depositary Share; Galapagos has a Level 3 ADS listed on Nasdaq with ticker symbol GLPG and CUSIP number 36315X101. One ADS is equivalent to one ordinary share in Galapagos NV
AFM
Dutch Authority for the Financial Markets
Anemia
Condition in which the patient has an inadequate number of red blood cells to carry oxygen to the body’s tissues
Anti-TNF
Tumor necrosis factor. An anti-TNF drug acts by modulation of TNF
Assays
Laboratory tests to determine characteristics
Attrition rate
The historical success rate for drug discovery and development, based on publicly known development paths. Statistically seen, investment in at least 12 target-based programs is required to ensure that at least one of these will reach a Phase 3 study. Most new drug R&D programs are discontinued before reaching Phase 3 because they are not successful enough to be approved
BID dosing
Twice-daily dosing (bis in die)
Bioavailability
Assessment of the amount of product candidate that reaches a body’s systemic circulation after (oral) administration
Biomarker
Substance used as an indicator of a biological process, particularly to determine whether a product candidate has a
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Galapagos NV • H1 Report 2021
biological effect
Black & Scholes model
A mathematical description of financial markets and derivative investment instruments that is widely used in the pricing of European options and warrants
Bridging trial
Clinical trial performed to "bridge" or extrapolate one dataset to that for another situation, i.e. to extrapolate data from one population to another for the same drug candidate, or to move from IV to subcutaneous dosing
CALOSOMA
Phase 1 program with GLPG3970 in psoriasis
Cash position
Current financial investments and cash and cash equivalents
CDAI
Crohn’s Disease Activity Index, evaluating patients on eight different factors, each of which has a pre-defined weight as a way to quantify the impact of CD
CDAI remission
In the FITZROY trial, the percentage of patients with CD who showed a reduction of CDAI score to <150
CFTR
Cystic fibrosis transmembrane conductance regulator (CFTR) is a membrane protein and chloride channel in vertebrates that is encoded by the CFTR gene. It is hypothesized that inhibition of the CFTR channel might reduce cyst growth and enlargement for patients with ADPKD. GLPG2737 is a CFTR inhibitor
CHIT1/AMCase
Chitotriosidase (CHIT1) is a protein coding gene, and AMCase is an inactive acidic mamalian chitinase. CHIT1 is predominantly involved in macrophage activation. Inhibition of chitinase activity translates into a potential therapeutic benefit in lung diseases like IPF, as shown in preclinical models. GLPG4716 is a CHIT1/AMCase inhibitor targeting a key pathway in tissue remodeling
Chitinase
Chitinase is an enzyme that degrades chitin, involved in the human innate immunity. Inhibition of chitinase activity translates into a potential therapeutic benefit in lung diseases like IPF, as shown in preclinical models
CHMP
Committee for Medicinal Products for Human Use is the European Medicines Agency's (EMA) committee responsible for human medicines and plays a vital role in the authorization of medicines in the European Union (EU)
CIR
Crédit d’Impôt Recherche, or research credit. Under the CIR, the French government refunds up to 30% of the annual investment in French R&D operations, over a period of three years. Galapagos benefits from the CIR through its operations in Romainville, just outside Paris
Clinical Proof of Concept (PoC)
Point in the drug development process where the product candidate shows efficacy in a therapeutic setting
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Galapagos NV • H1 Report 2021
Complete Response Letter (CRL)
A letter send by the FDA to indicate that the review cycle for an application is complete and the application is not ready for approval in its present form
Compound
A chemical substance, often a small molecule with drug-like properties
Contract research organization (CRO)
Organization which provides drug discovery and development services to the pharmaceutical, biotechnology and medical devices industry
Corticosteroids
Any of a group of steroid hormones produced in the adrenal cortex or made synthetically. They have various metabolic functions and some are used to treat inflammation
Crohn's disease (CD)
An IBD involving inflammation of the small and large intestines, leading to pain, bleeding, and ultimately in some cases surgical removal of parts of the bowel
CRP
C-reactive protein is a protein found in the blood, the levels of which rise in response to inflammation
Cytokine
A category of small proteins which play important roles in signaling in processes in the body
DARWIN
Phase 2 program for filgotinib in RA. DARWIN 1 explored three doses, in twice-daily and once-daily administration, for up to 24 weeks in RA patients with insufficient response to methotrexate (MTX) and who remained on their stable background treatment with MTX. DARWIN 2 explored three once-daily doses for up to 24 weeks in RA patients with insufficient response to methotrexate (MTX) and who washed out of their treatment with MTX. DARWIN 1 and 2 were double-blind, placebo-controlled trials which recruited approximately 900 patients globally and for which results were reported in 2015. DARWIN 3 is a long term extension trial in which all patients are on 200 mg filgotinib, except for U.S. males who are on 100 mg. The week 156 results from DARWIN 3 were reported in 2019
DAS28 (CRP)
DAS28 is an RA Disease Activity Score based on a calculation that uses tender and swollen joint counts of 28 defined joints, the physician’s global health assessment and a serum marker for inflammation, such as C- reactive protein. DAS28 (CRP) includes the C-reactive protein score calculation: scores range from 2.0 to 10.0, with scores below 2.6 being considered remission
DDI study
Drug-drug interaction study. This type of study will assess if there is a change in the action or side effects of a drug caused by concomitant administration with another drug
Deep venous thrombosis (DVT)
The formation of one or more blood clots in one of the body's large veins, most commonly in the lower limbs. The blood clots can travel to the lung and cause a pulmonary embolism
Degradation
The process by which proteins are lost through the use of drugs such as PROTACs or small molecules
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Galapagos NV • H1 Report 2021
Development
All activities required to bring a new drug to the market. This includes preclinical and clinical development research, chemical and pharmaceutical development and regulatory filings of product candidates
Discovery
Process by which new medicines are discovered and/or designed. At Galapagos, this is the department that oversees target and drug discovery research through to nomination of preclinical candidates
Disease-modifying
Addresses the disease itself, modifying the disease progression, not just the symptoms of the disease
DIVERGENCE
Phase 2 programs with filgotinib in Crohn's disease. DIVERGENCE 1 was an exploratory study in small bowel CD and DIVERGENCE 2 in fistulizing CD
DIVERSITY
Phase 3 program evaluating filgotinib in CD
DMARDs
Disease modifying anti rheumatic drugs; these drugs address the disease itself rather than just the symptoms
Dose-range finding study
Phase 2 clinical study exploring the balance between efficacy and safety among various doses of treatment in patients. Results are used to determine doses for later studies
Double-blind
Term to characterize a clinical trial in which neither the physician nor the patient knows if the patient is taking placebo or the treatment being evaluated
Efficacy
Effectiveness for intended use
EMA
European Medicines Agency, in charge of European market authorization of new medications
Endoscopy
A non-surgical procedure involving use of an endoscope to examine a person’s digestive tract
Fast Track
A designation by the FDA of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need
FDA
The U.S. Food and Drug Administration is an agency responsible for protecting and promoting public health and in charge of American market approval of new medications
Fee-for-service
Payment system where the service provider is paid a specific amount for each procedure or service performed
FIH
First-in-human clinical trial, usually conducted in healthy volunteers with the aim to assess the safety, tolerability and pharmacokinetics of the product candidate
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Galapagos NV • H1 Report 2021
Filgotinib
Formerly known as GLPG0634, commercial name is Jyseleca. Small molecule preferential JAK1 inhibitor, approved in RA in Europa and Japan. Application for approval for ulcerative colitis was filed in Europe and Japan. Filgotinib is partnered with Gilead. Filgotinib currently is in Phase 3 trials in CD, and in a Phase 4 trial in RA
FILOSOPHY
Phase 4 program evaluating filgotinib in RA
FINCH
Phase 3 program evaluating filgotinib in RA
Fistulizing CD
Fistulae are inflammatory tracts that most often occur between the distal colon and the perianal region. Fistulae are one of the most severe sequelae of luminal CD and the lifetime risk of occurrence is close to 50% of those with active CD
FITZROY
A double-blind, placebo controlled Phase 2 trial with filgotinib in 177 CD patients for up to 20 weeks. Full results were published in The Lancet in 2016
FORM 20-F
Form 20-F is an SEC filing submitted to the US Securities and Exchange
FSMA
The Belgian market authority: Financial Services and Markets Authority, or Autoriteit voor Financiële Diensten en Markten
FTE
Full-time equivalent; a way to measure an employee’s involvement in a project. For example, an FTE of 1.0 means that the equivalent work of one full-time worker was used on the project
Futility analysis
Analysis of the likelihood of a trial to meet its primary endpoint, based on a subset of the total information to be gathered. The term 'futility' is used to refer to the low likelihood of a clinical trial to achieve its objectives. In particular, stopping a clinical trial when the interim results suggest that it is unlikely to achieve statistical significance can save resources that could be used on more promising research
G&A expenses
General & administrative expenses
Genome
An organism's complete set of genetic information needed to build that organism and allow it to grow and develop
GLIDER
Phase 2 Proof of Concept trial with SIK2/3 inhibitor GLPG3970 in Sjögren's syndrome
GLPG0555
A JAK1 inhibitor currently in Phase 1b in osteoarthritis
GLPG0634
Molecule number currently known as filgotinib and Jyseleca
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Galapagos NV • H1 Report 2021
GLPG1690
Molecule currently known as ziritaxestat. All development with ziritaxestat was discontinued in February 2021
GLPG2737
A compound currently in Phase 2 in PKCD. This compound is part of the CF collaboration with AbbVie but Galapagos regained rights outside of CF
GLPG3121
A compound currently in Phase 1 targeting JAK1/TYK2 directed toward inflammation (IBD)
GLPG3667
A TYK2 kinase inhibitor discovered by us, topline results from the Phase 1b in psoriasis reported in July 2021
GLPG3970
A SIK2/3 inhibitor currently in multiple Phase 2 Proof of Concept studies. Topline results from the studies in UC, psoriasis and RA reported in July 2021
GLPG4399
A SIK3 inhibitor currently in Phase 1 directed toward inflammation
GLPG4586
A compound with undisclosed mode of action currently in the preclinical phase directed toward fibrosis. This is the first preclinical candidate to emerge from the collaboration with Fibrocor
GLPG4605
A SIK2/3 inhibitor in the preclinical phase, currently directed toward fibrosis
GLPG4716
A chitinase inhibitor inlicensed from OncoArendi in preparation for Phase 2 in IPF
GLPG4876
A SIK2/3 inhibitor in the preclinical phase, currently directed toward inflammation. This molecule was selected for acceleration in 2021
HDL
High-density lipoprotein. HDL scavenges and reduces low-density lipoprotein (LDL) which contributes to heart disease at high levels. High levels of HDL reduce the risk for heart disease, while low levels of HDL increase the risk of heart disease
Hemoglobin
A protein inside red blood cells that carries oxygen from the lungs to tissues and organs in the body and carries carbon dioxide back to the lungs
Histology
Study of the microscopic structures of tissues
Histopathology
Microscopic examination of tissues for manifestations of a disease
IBD
Inflammatory Bowel Disease. This is a general term for an autoimmune disease affecting the bowel, including CD and UC. CD affects the small and large intestine, while UC affects the large intestine. Both diseases involve inflammation of the intestinal wall, leading to pain, bleeding, and ultimately, in some cases, surgical removal of part of the bowel
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In-/out-licensing
Receiving/granting permission from/to another company or institution to use a brand name, patent, or other proprietary right, in exchange for a fee and/or royalty
In vitro
Studies performed with cells outside their natural context, for example in a laboratory
In vivo
Studies performed with animals in a laboratory setting
Inflammatory diseases
A large, unrelated group of disorders associated with abnormalities in inflammation
Intellectual property
Creations of the mind that have commercial value and are protected or protectable, including by patents, trademarks or copyrights
Intersegment
Occurring between the different operations of a company
Investigational New Drug (IND) Application
United States Federal law requires a pharmaceutical company to obtain an exemption to ship an experimental drug across state lines, usually to clinical investigators, before a marketing application for the drug has been approved. The IND is the means by which the sponsor obtains this exemption, allowing them to perform clinical studies
IPF
Idiopathic pulmonary fibrosis. A chronic and ultimately fatal disease characterized by a progressive decline in lung function. Pulmonary fibrosis involves scarring of lung tissue and is the cause of shortness of breath. Fibrosis is usually associated with a poor prognosis. The term “idiopathic” is used because the cause of pulmonary fibrosis is still unknown
JAK
Janus kinases (JAK) are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in RA. Filgotinib is a selective JAK1 inhibitor
Jyseleca®
Jyseleca® is the brand name for filgotinib
LADYBUG
Phase 2 program with GLPG3970 in rheumatoid arthritis
LDL
Low-density lipoprotein. LDL contributes to heart disease at high levels
Lipoprotein
Lipoproteins are substances made of protein and fat that carry cholesterol through your bloodstream. There are two main types of cholesterol: High-density lipoprotein (HDL), or "good" cholesterol and Low-density lipoprotein (LDL), or "bad" cholesterol
Liver enzymes
Inflamed or injured liver cells secrete higher than normal amounts of certain chemicals, including liver enzymes, into the bloodstream
Lymphocyte
Type of white blood cell that is part of the immune system
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MACE
Major adverse cardiovascular events; a composite endpoint frequently used in cardiovascular research
MANGROVE
Phase 2 program with GLPG2737 in polycystic kidney disease
MANTA
A Phase 2 semen analysis trial with filgotinib in male patients with CD or UC
MANTA-RAy
Phase 2 semen analysis trial with filgotinib in male patients with RA, PsA, or AS
Mayo Score
Mayo Score is a Disease Activity Score for ulcerative colitis. It is a composite of subscores from four categories, including stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy, and physician's global assessment, with a total score ranging from 0–12
MHLW
Japanese Ministry of Health, Labor and Welfare (MHLW), in charge of Japanese market authorization of new medications
Milestone
Major achievement in a project or program; in our alliances, this is usually associated with a payment
Modulation
The process by which the function of proteins is changed through the use of drugs such as small molecules, peptides, antibodies or cell therapy
Molecule collections
Chemical libraries, usually consisting of drug-like small molecules that are designed to interact with specific target classes. These collections can be screened against a target to generate initial “hits” in a drug discovery program
MTX
Methotrexate; a first-line therapy for inflammatory diseases
NDA
New Drug Application
Neutrophil
Type of immune system cell which is one of the first cell types to travel to the site of an infection in the body. Neutrophils are another type of white blood cell which fight infection by ingesting and killing microorganisms
NICE
The National Institute for Health and Care Excellence; an independent public body that provides national guidance and advice to improve health and social care in the UK
NK cells
Natural killer cells, type of white blood cell with granules of enzymes which can attack tumors or viruses
Oligonucleotide
Short DNA or RNA molecule that can be used as research tools or therapeutic drug to change protein expression
Oral dosing
Administration of medicine by the mouth, either as a solution or solid (capsule, pill) form
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Osteoarthritis (OA)
The most common form of arthritis, usually occurring after middle age, marked by chronic breakdown of cartilage in the joints leading to pain, stiffness, and swelling
Outsourcing
Contracting work to a third party
PASI
Psoriasis Area and Severity Index; an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area
PCKD
Polycystic kidney disease is a genetic disorder in which the renal tubules become structurally abnormal, resulting in the development and growth of multiple cysts within the kidney
Pharmacokinetics (PK)
Study of what a body does to a drug; the fate of a substance delivered to a body. This includes absorption, distribution to the tissues, metabolism and excretion. These processes determine the blood concentration of the drug and its metabolite(s) as a function of time from dosing
Phase 1
First stage of clinical testing of an investigational drug designed to assess the safety and tolerability, pharmacokinetics of a drug, usually performed in a small number of healthy human volunteers
Phase 2
Second stage of clinical testing, usually performed in no more than several hundred patients, in order to determine efficacy, tolerability and the dose to use
Phase 3
Large clinical trials, usually conducted in several hundred to several thousand patients to gain a definitive understanding of the efficacy and tolerability of the candidate treatment; serves as the principal basis for regulatory approval
Phenotypic screening
Phenotypic screening is a strategy used in drug discovery to identify molecules with the ability to alter a cell’s disease characteristics. Animal models and cell-based assays are both strategies used to identify these molecules. In contrast to target-based drug discovery, phenotypic screening does not rely on knowing the identity of the specific drug target or its hypothetical role in the disease. A key benefit this approach has over target-based screening, is its capacity to capture complex biological mechanisms that are not otherwise achievable
Pivotal trials
Registrational clinical trials
Placebo
A substance having no pharmacological effect but administered as a control in testing a biologically active preparation
Preclinical
Stage of drug research development, undertaken prior to the administration of the drug to humans. Consists of in vitro and in vivo screening, pharmacokinetics, toxicology, and chemical upscaling
Preclinical candidate (PCC)
A new molecule and potential drug that meets chemical and biological criteria to begin the development process
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Product candidate
Substance that has satisfied the requirements of early preclinical testing and has been selected for development, starting with formal preclinical safety evaluation followed by clinical testing for the treatment of a certain disorder in humans
Proof of Concept (POC)
A clinical trial in which first evidence for efficacy of a candidate drug is gathered. A Proof of Concept trial is usually with a small number of patients and for short duration to get a first impression of drug activity
Proof of Concept study
Phase 2 patient study in which activity as well as safety in patients is evaluated, usually for a new mechanism of action
PROTAC
Proteolysis targeting chimera, a special small molecule capable of removing unwanted proteins that play a role in disease processes
Psoriasis
A chronic skin disease which results in scaly, often itchy areas in patches
Psoriatic arthritis (PsA)
Psoriatic arthritis or PsA is an inflammatory form of arthritis, affecting up to 30% of psoriasis patients. Psoriatic arthritis can cause swelling, stiffness and pain in and around the joints, and cause nail changes and overall fatigue
Pulmonary embolisms
A blockage in one of the pulmonary arteries in the lungs
QD dosing
Once-daily dosing (qd from the Latin quaque die)
R&D operations
Research and development operations; unit responsible for discovery and developing new product candidates for internal pipeline or as part of risk/reward sharing alliances with partners
Replication
The process by which DNA is copied to produce two identical DNA molecules during the process of cell division
Rheumatoid arthritis (RA)
A chronic, systemic inflammatory disease that causes joint inflammation, and usually leads to cartilage destruction, bone erosion and disability
Screening
Method usually applied at the beginning of a drug discovery campaign, where a target is tested in a biochemical assay against a series of small molecules or antibodies to obtain an initial set of “hits” that show activity against the target. These hits are then further tested or optimized
SEA TURTLE
Phase 2 program with GLPG3970 in ulcerative colitis
SEC
Securities Exchange Commission in the US
SELECTION
Phase 3 program evaluating filgotinib in UC patients. Full results were published in The Lancet in 2021
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SES-CD scores
Simple endoscopic score for CD, involving review of five pre-defined bowel segments, assigning values from 0 (unaffected) to 3 (highly affected)
Short interfering RNA
A research tool that is used to silence the activity of specific genes
SIK
Salt-inducible kinase. This is the target family for the portfolio of molecules in the Toledo program
Sjögren’s syndrome
Sjögren’s syndrome is a systemic inflammatory disease which can be felt throughout the body, often resulting in chronic dryness of the eyes and mouth
S&M expenses
Sales and marketing expenses
Small bowel CD (SBCD)
CD causes chronic inflammation and erosion of the intestines. It can affect different regions of gastrointestinal tract including the stomach and small and large intestines. While isolated SBCD is an uncommon presentation of CD, involvement of some portion of the small bowel, particularly the ileum, is common
Statin
Statins are a class of lipid-lowering medications that reduce illness and mortality in those who are at high risk of cardiovascular disease. They are the most common cholesterol-lowering drugs. Low-density lipoprotein (LDL) carriers of cholesterol play a key role in the development of atherosclerosis and coronary heart disease via the mechanisms described by the lipid hypothesis
Systemic lupus erythematosus
An autoimmune disease, with systemic manifestations including skin rash, erosion of joints or even kidney failure
TAPINOMA
Phase 1b Proof of Concept trial with SIK2/3 inhibitor GLPG3970 in SLE
Target
Protein that has been shown to play a role in a disease process and that forms the basis of a therapeutic intervention or discovery of a medicine.
Target discovery
Identification and validation of proteins that have been shown to play a role in a disease process
TEAE
Treatment Emergent Adverse Event, is any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments
Technology access fee
License payment made in return for access to specific technology (e.g. compound or virus collections)
Toledo
Toledo is the program name for the target family of SIK inhibitors
Topical corticosteroids
Corticosteroids which are administered through the skin using an ointment
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Transcription
The process of making an RNA copy of a DNA gene sequence
Translation
The process by which a protein is synthetized from mRNA
TYK
Tyrosine kinase is an enzyme that can transfer a phosphate group from ATP to the tyrosine residues of specific proteins inside a cell. It functions as an "on" or "off" switch in many cellular functions. Tyrosine kinases belong to a larger class of enzymes known as protein kinases which also attach phosphates to other amino acids such as serine and threonine. GLPG3667 is a reversible and selective TYK2 kinase domain inhibitor
Ulcerative colitis (UC)
UC is an IBD causing chronic inflammation of the lining of the colon and rectum (unlike CD with inflammation throughout the gastrointestinal tract)
Venous thrombotic events
When a blood clot breaks loose and travels in the blood, this is called a venous thromboembolism (VTE). The abbreviation DVT/PE refers to a VTE where a deep vein thrombosis (DVT) has moved to the lungs (PE or pulmonary embolism)
Ziritaxestat
Formerly known as GLPG1690. Ziritaxestat is a novel drug candidate targeting autotaxin; all development with ziritaxestat was discontinued in February 2021
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Financial calendar
November 04, 2021
Third quarter 2021 Results
February 24, 2022
Full Year 2021 Results
Financial year
The financial year starts on January 1 and ends on December 31.
Auditor
Deloitte Bedrijfsrevisoren CVBA, represented by Nico Houthaeve
Luchthaven Nationaal 1, bus J, 1930
Zaventem, Belgium
Colophon
Concept, design, and online programming
nexxar GmbH, Vienna - Online annual reports and online sustainability reports
www.nexxar.com
Photography
Frank van Delft
Copy deadline: August 05, 2021
This report is also available in Dutch and available for download at www.glpg.com
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Contact
|
| Elizabeth Goodwin Vice President Investor Relations Galapagos NV 230 Third Ave Waltham, MA 02451, United States Tel. +1 781 291 3750 Email: ir@glpg.com |
| | Sofie Van Gijsel Senior Director Investor Relations Galapagos NV Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium Tel. +1 781 296 1143 Email: ir@glpg.com |
| | Sandra Cauwenberghs Director of Investor Relations Galapagos NV Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium Tel. +32 495 58 46 63 Email: ir@glpg.com |
| | Carmen Vroonen Global Head of Communications & Public Affairs Galapagos NV Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium Tel. +32 473 82 48 74 Email: communications@glpg.com |
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