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Galapagos NV — Interim / Quarterly Report 2021
May 6, 2021
3954_10-q_2021-05-06_4df6a266-0a5d-4535-8f51-434a9c79f73c.pdf
Interim / Quarterly Report
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2021 Q1 Report Forward with confidence
Contents
The Galapagos group
| Letter from the management 4 | |
|---|---|
| COVID-19 impact 9 | |
| At a glance 11 | |
| Risk factors 13 | |
| The Galapagos share 13 | |
| Disclaimer and other information 14 |
Financial statements
| Unaudited condensed consolidated interim | |
|---|---|
| financial statements 17 | |
| Notes 24 |
Auditor's report
Report on the review of the condensed consolidated interim financial statements ... 34
Other information
| Glossary of terms 35 | |
|---|---|
| Financial calendar 50 | |
| Colophon 50 | |
| Contact 51 |
The Galapagos group
An overview of Galapagos, its strategy and portfolio in the first three months of 2021
Forward with confidence
Letter from the management
Dear shareholders,
We present you with our report on the first quarter of 2021, one in which we both delivered progress with and faced adversity in our pipeline, while driving our commercial business in Europe through the launch of Jyseleca (filgotinib) in rheumatoid arthritis (RA). We move forward with confidence at Galapagos, applying lessons learned to our pipeline decisions, and re-fitting our organization to the new situation.
In February, we announced the end of the development program for ziritaxestat, a molecule in Phase 3 trials in idiopathic pulmonary fibrosis (IPF), due to the unfavorable risk/benefit profile observed by an Independent Data Monitoring Committee (IDMC). As disappointed as we were, and for patients in need of a new treatment option in this very complex, debilitating condition, we continue to work hard on our differentiated pipeline.
These last months, we embarked on a review of our plans. We listened to our shareholders and had constructive discussions with our R&D teams and management board members, as well as with our supervisory board. We all agree that our scientific foundations are solid, we have outstanding teams, and we have the financial resources to execute our own programs as well as to enrich our pipeline.
Onno van de Stolpe, CEO Bart Filius, President & COO
We do not intend to deviate from our mission to build on novel targets to address unmet medical needs in inflammation, fibrosis, and kidney disease. Also, we remain fully committed to the launch of filgotinib in Europe. Our teams are working very hard to ensure our drug reaches the greatest number of patients and we've already hit some important milestones in RA. Furthermore, Gilead submitted the new drug application in Japan for filgotinib for the treatment of ulcerative colitis (UC) patients with an inadequate response to conventional therapies, and, in Europe, we anticipate a Committee for Medicinal Products for Human Use (CHMP) opinion on the submission for potential approval in UC later this year.
The key objective of our exercise was to refocus development plans for 2021, taking lessons learned on board and right-sizing our organization with the goal to select a more risk-balanced pipeline.
In the end we made three key decisions:
-
- Refocus our clinical pipeline by critically examining its risk profile and breadth;
-
- Cut significant cost in the organization to support this re-sized pipeline development; and
-
- Task our business development team to identify and execute on a transformative opportunity.
Starting with our pipeline, we carefully evaluated the risk-balance and prioritized assets with what we believe have enhanced chances of clinical success in our core therapeutic areas:
- We are testing our lead Toledo program '3970, a SIK2/3 inhibitor, in five Proof of Concept studies in different indications, and pending on the outcome of the studies, we plan to roll out our further development plans in the second half of the year;
- We selected an additional molecule from our Toledo program, SIK2/3 inhibitor '4876, as a candidate to accelerate from preclinical phase into clinical development;
- We aim to progress our TYK2 inhibitor '3667 into Phase 2b;
- We selected chitinase inhibitor '4617 to progress to Phase 2 in IPF and decided to stop development of our other IPF molecule '1205;
- We stopped further work on '4059 for metabolic disease, given that this is not a core therapeutic area;
- We discontinued our early research efforts in metabolic diseases and osteoarthritis (OA); and
- We challenged and fine-tuned our stage-gating process to advance compounds.
Our reviewed pipeline offers significant newsflow and we look forward to sharing results this year and next.
In line with our review, we decided to discontinue or cancel certain studies, and we identified opportunities to reduce operational costs, for a total potential savings of €150 million on a full-year basis. Roughly half of these savings will be realized in 2021, resulting in a 2021 cash burn guidance of between €580 million and €620 million.
Meanwhile, we remain well on track in launching filgotinib in Europe. In the first quarter, we successfully completed the transitions of commercial and medical teams from Gilead in Germany, the UK, Spain, and Italy. Everything is in place to complete the final transitions from Gilead to us by year-end. Q1 also saw progress on access and reimbursement for filgotinib in RA. We are delighted with the recommendation by the National Institute for Health and Care Excellence (NICE) for filgotinib in the UK for the treatment of eligible adult patients with moderate to severe active RA. Furthermore, we received an additional benefit in RA by the Gemeinsamer Bundesausschuss (G-BA) in Germany. We are encouraged by the primary endpoint outcome with the MANTA/RAy semen parameter studies as we await the CHMP opinion in UC.
We are pleased that our partner Gilead recently announced an extension of the lockup period for their current holding in Galapagos (16,707,477 shares) until 2024, which is testament to their continued support.
Altogether, these adjustments make for a right-sized, refocused version of Galapagos, on a path towards success with our first commercial product as well as with new R&D opportunities, substantial clinical news flow, and a lengthened cash runway for clinical validation of our early assets.
Operational overview Q1 2021
In inflammation
- We and Gilead announced interim data on the MANTA/RAy studies. 8.3% of patients on placebo and 6.7% of patients on filgotinib had a 50% or more decline in sperm concentration at week 13; these results are being shared with regulatory authorities
- We initiated two additional Proof of Concept trials with Toledo compound '3970, a SIK2/3 inhibitor. The first patients were dosed in both the TAPINOMA study in systemic lupus erythematosus and in the GLIDER study in Sjögren's syndrome
- Gilead announced that NICE recommended filgotinib for reimbursement for moderate to severe RA patients in the UK
- We published the FINCH 1 Phase 3 data (Combe et al. 2021) and FINCH 3 Phase 3 data (Westhovens et al. 2021) in the Annals of the Rheumatic Diseases
In fibrosis
▪ We discontinued development of ziritaxestat in the ISABELA Phase 3 program in IPF
Corporate & other
- Bart Filius was promoted to President and Chief Operating Officer
- We raised €2.3 million from subscription right exercises
Recent events
- All annual general meeting (AGM) proposals were approved by shareholders at the AGM on 28 April 2021
- We received a transparency notification from the Capital Group indicating they hold 4.65% of the current outstanding Galapagos shares
- Gilead submitted the new drug application in Japan for filgotinib for the treatment of UC with an inadequate response to conventional therapies
- We and Gilead ended the DIVERGENCE 2 trial with filgotinib in fistulizing CD
- We completed enrollment of the SEA TURTLE Phase 2 study with '3970 in UC
- We announced an extension of the lockup period for Gilead's current shares in Galapagos to 2024
- We received the second installment of €75 million from Gilead, following payment of an earlier installment of €35 million in January 2021, included under the revised filgotinib agreement as announced in December 2020
Q1 2021 financial result
Details of financial results
Due to the sale of our fee-for-service business (Fidelta) to Selvita on 4 January 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 profit from discontinued operations" in our consolidated income statements.
Revenues and other income from continuing operations
Our revenues and other income from continuing operations for the first three months of 2021 amounted to €124.2 million, compared to €103.6 million for the first three months of 2020.
Revenues amounted to €113.9 million for the first three months of 2021 compared to €94.8 million for the first three 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 €55.3 million for the first three months of 2021 (€35.4 million for the same period last year).
Other income (€10.3 million vs €8.7 million for the same period last year) increased, mainly driven by higher incentives income from the government for our R&D activities.
Results from continuing operations
We realized a net loss from continuing operations of €12.8 million for the first three months of 2021, compared to a net loss of €52.3 million for the first three months of 2020.
We reported an operating loss amounting to €50.8 million for the first three months of 2021, compared to an operating loss of €46.2 million for the same period last year.
Our R&D expenditure in the first three months of 2021 amounted to €130.0 million, compared to €115.5 million for the first three months of 2020. This increase was due to an increase in subcontracting costs primarily related to our filgotinib program, our Toledo program and other clinical programs, compensated by a decrease for ziritaxestat, the OA program with GLPG1972 and the program in atopic dermatitis (AtD) with MOR106. Furthermore, personnel costs increased explained by a planned headcount increase following the growth of our activities and increased cost 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 €45.0 million in the first three months of 2021, compared to €34.3 million in the first three months of 2020.
We reported a non-cash fair value gain from the re-measurement of initial warrant B issued to Gilead, amounting to €2.0 million, mainly due to the decreased implied volatility of the Galapagos share price as well as its evolution between 31 December 2020 and 31 March 2021.
Net other financial income in the first three months of 2021 amounted to €36.2 million, compared to net other financial income of €14.8 million for the first three months of 2020, which was primarily attributable to €45.5 million of currency exchange gain on our cash and cash equivalents and current financial investments in U.S. dollars and to €6.5 million of negative changes in (fair) value of current financial investments and financial assets.
Results from discontinued operations
The net profit from discontinued operations for the three months ended 31 March 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 profit for the first three months of 2021 amounting to €9.4 million, compared to a net loss of €50.6 million for the same period in 2020.
Cash position
Current financial investments and cash and cash equivalents totaled €5,114.7 million on 31 March 2021 (€5,169.3 million on 31 December 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 €54.6 million in the first three months of 2021, compared to a net decrease of €58.4 million during the first three months of 2020. This net decrease was composed of (i) €127.7 million of operational cash burn,1 (ii) offset by €2.3 million of cash proceeds from capital and share premium increase from exercise of subscription rights in the first three months of 2021, (iii) €3.6 million of negative changes in (fair) value of current financial investments and €45.7 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 on 31 March 2021 held a receivable from the French government (Crédit d'Impôt Recherche 2 ) and a receivable from the Belgian Government for R&D incentives, for a total of €142.3 million.
Outlook 2021
We anticipate regulatory announcements with filgotinib as well as news on progress in our differentiated pipeline of novel target-based candidates this year.
We expect reimbursement decisions in most key European markets for filgotinib in RA this year, as we complete the transition to a full European commercial operation by year end. We anticipate a CHMP opinion and a European Commission decision for filgotinib in UC. We expect that our collaboration partner Gilead will complete recruitment for the global DIVERSITY Phase 3 trial in Crohn's disease this year.
Within our broader inflammation portfolio, we expect to report topline results from several trials this year, including a Phase 1b trial with TYK2 inhibitor '3667 in psoriasis and three Proof of Concept studies with lead Toledo candidate SIK2/3 inhibitor '3970 in psoriasis, UC, and RA.
Within our fibrosis portfolio, we expect to progress early clinical compounds with novel mechanisms of action, with the aim to develop novel treatments to help patients suffering from this debilitating condition.
Following the review of our plans for 2021, we give guidance for full year 2021 operational cash burn of €580 to €620 million, and potential savings of €150 million on a full-year basis.
We thank you for your continued support, as we move forward on our strategy to develop novel mechanism of action drugs aimed at addressing unmet need in inflammation, fibrosis, and kidney disease. We are confident that we have a strong cash position, expert teams, and excellent science to achieve this.
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
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 implemented strict measures 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, including suspending almost all business travel. We continue to believe that during the pandemic most of the international travel can be replaced by virtual meetings, resulting in improved cost efficiency, a better work-life balance, and a reduced carbon footprint. The positive impact of this forced wayof-working will therefore be retained in our future habits and updated work place strategy, called "To the Next Normal."
During lock-down periods, we arranged for essential tasks to be carried out within our facilities. Employees working on site need an authorization letter signed by the line leader and site head. 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. Except for employees with laboratory operations and safety roles which require an on-site presence, over 95% of our staff systematically work from home.
As the global pandemic continues into 2021, we anticipate that we will maintain our measures and protocols to ensure the health of our employees.
▪ Research portfolio
By prioritizing the most advanced projects very early on, increasing the flexibility of our staff in the labs within projects, and maintaining our hiring efforts and outscourcing as planned, we sustain our research delivery, keep the compound management facility running at all times, and continue our early drug research and the implementation of new modalities for target or drug discovery.
So far, the scorecard of the research department objectives shows a similar productivity compared to previous years, indicating that we continue to minimize the impact of the pandemic.
▪ Development 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 to 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.
▪ Filgotinib filing process UC
As of publication of this Q1 report, our collaboration partner Gilead has not been informed by the regulatory agencies in Europe of approval timeline delays related to the pandemic.
▪ Manufacturing and supply chain
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 intend to work with the same manufacturing sites to ensure continuity.
▪ Commercial organization
The form of outreach of our commercial teams to physicians and hospitals was impacted by the COVID-19 pandemic and consequent travel restrictions, becoming virtual instead. The teams invested in virtual channels as part of the overall commercial build strategy, and these channels are being utilized during our commercial launch today. We note as of now 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 thus far. 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 initiations.
At a glance
Consolidated Key Figures
| (thousands of €, if not stated otherwise) | Three months ended 31 March 2021 |
Three months ended 31 March 2020 |
Year ended 31 December 2020 |
|---|---|---|---|
| Income Statement(*) | |||
| Revenues | 113,892 | 94,817 | 478,053 |
| Other income | 10,266 | 8,743 | 52,207 |
| R&D expenditure | (129,960) | (115,453) | (523,667) |
| S, G&A expenses | (44,996) | (34,325) | (185,225) |
| Operating expenses | (174,956) | (149,778) | (708,892) |
| Operating loss | (50,798) | (46,218) | (178,632) |
| Net financial results | 38,125 | (5,705) | (131,143) |
| Taxes | (157) | (336) | (1,226) |
| Net loss from continuing operations | (12,830) | (52,258) | (311,001) |
| Net profit from discontinued operations, net of tax | 22,191 | 1,657 | 5,565 |
| Net profit/loss (–) | 9,361 | (50,601) | (305,436) |
| Balance Sheet | |||
| Cash and cash equivalents | 2,553,950 | 2,743,573 | 2,135,187 |
| Current financial investments | 2,560,743 | 2,978,805 | 3,026,278 |
| R&D incentives receivables | 142,304 | 115,240 | 135,728 |
| Assets | 5,615,059 | 5,992,406 | 5,717,731 |
| Shareholders' equity | 2,701,462 | 2,840,041 | 2,670,355 |
| Deferred income | 2,698,417 | 2,913,398 | 2,809,133 |
| Other liabilities | 215,180 | 238,968 | 238,242 |
| Cash Flow | |||
| Operational cash burn(**) | (127,669) | (83,398) | (517,404) |
| Cash flow used in operating activities | (121,209) | (68,874) | (427,336) |
| Cash flow generated from investing activities | 499,859 | 929,640 | 757,288 |
| Cash flow generated from financing activities | 478 | 3,930 | 22,040 |
| Increase in cash and cash equivalents | 379,129 | 864,695 | 351,994 |
| Effect of currency exchange rate fluctuation on cash and cash equivalents |
31,750 | 17,261 | (70,539) |
| Cash and cash equivalents at end of the period | 2,553,950 | 2,743,573 | 2,143,071 |
(*) The comparatives of 31 March 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 31 December 2020 and on 31 March 2020 included respectively 185 and 164 employees of Fidelta, which has been sold to Selvita on 4 January 2021.
THE GALAPAGOS GROUP
| (thousands of €, if not stated otherwise) | Three months ended 31 March 2021 |
Three months ended 31 March 2020 |
Year ended 31 December 2020 |
|---|---|---|---|
| Cash and cash equivalents from continuing operations | 2,553,950 | 2,743,573 | 2,135,187 |
| Cash and cash equivalents classified as assets held for sale | - | - | 7,884 |
| Current financial investments at the end of the period | 2,560,743 | 2,978,805 | 3,026,278 |
| Total current financial investments and cash and cash equivalents at the end of the period |
5,114,693 | 5,722,378 | 5,169,349 |
| Financial Ratios | |||
| Number of shares issued at end of the period | 65,511,581 | 64,819,022 | 65,411,767 |
| Basic income/loss (–) per share (in €) | 0.14 | (0.78) | (4.69) |
| Diluted income/loss (–) per share (in €) | 0.14 | (0.78) | (4.69) |
| Share price at end of the period (in €) | 66.12 | 181.00 | 80.48 |
| Total group employees at end of the period (number)(***) | 1,328 | 1,130 | 1,489 |
(*) The comparatives of 31 March 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 31 December 2020 and on 31 March 2020 included respectively 185 and 164 employees of Fidelta, which has been sold to Selvita on 4 January 2021.
Employees per site as of 31 March 2021
(total: 1,328 employees)
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
Performance of the Galapagos share on Euronext and Nasdaq
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 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: [email protected]
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 we 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
Euronext Amsterdam and Brussels: GLPG Nasdaq: GLPG
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 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,
THE GALAPAGOS GROUP
statements regarding the expected timing, design and readouts of ongoing and planned clinical trials (i) with filgotinib in ulcerative colitis and Crohn's disease, (ii) with GLPG4716 in IPF, (iii) with GLPG3970 in inflammation, ulcerative colitis, rheumatoid arthritis and psoriatic arthritis, (iv) with GLPG0555, GLPG4399 and GLPG3121 in inflammation, (v) with GLPG3667 in psoriasis, (vi) with GLPG2737 in PCKD, (vii) with GLPG4876 in inflammation, and (viii) with GLPG4586 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, the UK, 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, including in Europe, 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 the risk that data from our ongoing and planned clinical research programs in rheumatoid arthritis, Crohn's disease, ulcerative colitis, idiopathic pulmonary fibrosis, osteoarthritis, and other inflammatory indications 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), the timing of and the risks related to implementing the amendment of our arrangement with Gilead for the commercialization and development of filgotinib, 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 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.
Financial statements
Unaudited condensed consolidated interim financial statements for the first three months of 2021
Forward with confidence
Unaudited condensed consolidated interim financial statements for the first three months of 2021
Consolidated statements of income and comprehensive income/loss (-)
Consolidated income statement
| Three months ended 31 March | ||
|---|---|---|
| (thousands of €, except per share data) | 2021 | 2020(*) |
| Revenues | 113,892 | 94,817 |
| Other income | 10,266 | 8,743 |
| Total revenues and other income | 124,158 | 103,560 |
| Research and development expenditure | (129,960) | (115,453) |
| Sales and marketing expenses | (14,574) | (9,836) |
| General and administrative expenses | (30,422) | (24,489) |
| Total operating expenses | (174,956) | (149,778) |
| Operating loss | (50,798) | (46,218) |
| Fair value re-measurement of warrants | 1,970 | (20,529) |
| Other financial income | 47,500 | 39,682 |
| Other financial expenses | (11,345) | (24,858) |
| Loss before tax | (12,673) | (51,922) |
| Income taxes | (157) | (336) |
| Net loss from continuing operations | (12,830) | (52,258) |
| Net profit from discontinued operations, net of tax | 22,191 | 1,657 |
| Net profit/loss (–) | 9,361 | (50,601) |
| Net profit/loss (–) attributable to: | ||
| Owners of the parent | 9,361 | (50,601) |
| Basic income/loss (–) per share | 0.14 | (0.78) |
| Diluted income/loss (–) per share | 0.14 | (0.78) |
| Basic and diluted loss per share from continuing operations | (0.20) | (0.81) |
(*) The comparatives of 31 March 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.
FINANCIAL STATEMENTS
Consolidated statement of comprehensive income / loss (–)
| Three months ended 31 March | ||
|---|---|---|
| (thousands of €) | 2021 | 2020(*) |
| Net profit/loss (–) | 9,361 | (50,601) |
| Items that may be reclassified subsequently to profit or loss: | ||
| Translation differences, arisen from translating foreign activities | 298 | 401 |
| Realization of translation differences upon sale of foreign operations | 731 | - |
| Other comprehensive income/loss (–), net of income tax | 1,029 | 401 |
| Total comprehensive income/loss (–) attributable to: | ||
| Owners of the parent | 10,390 | (50,200) |
| Total comprehensive income/loss (–) attributable to owners of the parent arises from: |
||
| Continuing operations | (12,532) | (51,508) |
| Discontinued operations | 22,922 | 1,308 |
| Total comprehensive income/loss (–) | 10,390 | (50,200) |
(*) The comparatives of 31 March 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.
Consolidated statements of financial position
| 31 March | 31 December | |
|---|---|---|
| (thousands of €) | 2021 | 2020 |
| Assets | ||
| Intangible assets | 65,738 | 67,565 |
| Property, plant and equipment | 111,294 | 103,378 |
| Deferred tax assets | 4,440 | 4,475 |
| Non-current trade receivables | - | 50,000 |
| Non-current R&D incentives receivables | 118,199 | 111,624 |
| Other non-current assets | 4,466 | 11,343 |
| Non-current assets | 304,136 | 348,384 |
| Trade and other receivables | 156,242 | 148,418 |
| Current R&D incentives receivables | 24,105 | 24,104 |
| Current financial investments | 2,560,743 | 3,026,278 |
| Cash and cash equivalents | 2,553,950 | 2,135,187 |
| Other current assets | 15,882 | 11,953 |
| Current assets from continuing operations | 5,310,922 | 5,345,941 |
| Assets classified as held for sale | - | 23,406 |
| Total current assets | 5,310,922 | 5,369,347 |
| Total assets | 5,615,059 | 5,717,731 |
| Equity and liabilities | ||
| Share capital | 291,852 | 291,312 |
| Share premium account | 2,729,558 | 2,727,840 |
| Other reserves | (10,700) | (10,907) |
| Translation differences | (2,367) | (3,189) |
| Accumulated losses | (306,881) | (334,701) |
| Total equity | 2,701,462 | 2,670,355 |
| Retirement benefit liabilities | 14,859 | 14,996 |
| Non-current lease liabilities | 22,176 | 23,035 |
| Other non-current liabilities | 7,526 | 8,096 |
| Non-current deferred income | 2,263,674 | 2,365,974 |
| Non-current liabilities | 2,308,235 | 2,412,101 |
FINANCIAL STATEMENTS
| 31 March | 31 December | |
|---|---|---|
| (thousands of €) | 2021 | 2020 |
| Current lease liabilities | 6,475 | 6,401 |
| Trade and other liabilities | 161,867 | 172,386 |
| Current tax payable | 1,083 | 1,248 |
| Current financial instruments | 1,194 | 3,164 |
| Current deferred income | 434,743 | 443,159 |
| Current liabilities from continuing operations | 605,362 | 626,357 |
| Liabilities directly associated with assets classified as held for sale | - | 8,917 |
| Total current liabilities | 605,362 | 635,274 |
| Total liabilities | 2,913,597 | 3,047,375 |
| Total equity and liabilities | 5,615,059 | 5,717,731 |
The accompanying notes form an integral part of these condensed consolidated financial statements.
Consolidated cash flow statements
| Three months ended 31 March | ||
|---|---|---|
| (thousands of €) | 2021 | 2020 |
| Net profit/loss (–) of the period | 9,361 | (50,601) |
| Adjustment for non-cash transactions | (7,980) | 22,935 |
| Adjustment for items to disclose separately under operating cash flow | 792 | (747) |
| Adjustment for items to disclose under investing and financing cash flows | (28,842) | (2,596) |
| Change in working capital other than deferred income | 19,673 | 52,481 |
| Decrease in deferred income | (113,164) | (91,677) |
| Cash used in operations | (120,161) | (70,205) |
| Interest paid | (1,482) | (171) |
| Interest received | 648 | 2,745 |
| Corporate taxes paid | (214) | (1,243) |
| Net cash flows used in operating activities | (121,209) | (68,874) |
| Purchase of property, plant and equipment | (8,488) | (2,866) |
| Purchase of and expenditure in intangible fixed assets | (243) | (10,159) |
| Purchase of current financial investments | (201,188) | (2,187,948) |
| Interest received related to current financial investments | 6 | 2,596 |
| Sale of current financial investments | 677,032 | 3,130,686 |
| Cash in from disposal of subsidiaries, net of cash disposed of | 28,696 | - |
| Acquisition of financial assets | - | (2,670) |
| Proceeds from sale of financial assets held at fair value through profit or loss | 4,045 | - |
| Net cash flows generated from investing activities | 499,859 | 929,640 |
| Payment of lease liabilities | (1,780) | (1,425) |
| Proceeds from capital and share premium increases from exercise of subscription rights |
2,258 | 5,355 |
| Net cash flows generated from financing activities | 478 | 3,930 |
| Increase in cash and cash equivalents | 379,129 | 864,695 |
FINANCIAL STATEMENTS
| Three months ended 31 March | |||
|---|---|---|---|
| (thousands of €) | 2021 | 2020 | |
| Cash and cash equivalents at beginning of the period | 2,143,071 | 1,861,616 | |
| Increase in cash and cash equivalents | 379,129 | 864,695 | |
| Effect of exchange rate differences on cash and cash equivalents | 31,750 | 17,261 | |
| Cash and cash equivalents at the end of the period | 2,553,950 | 2,743,573 |
The accompanying notes form an integral part of these condensed consolidated financial statements.
| 31 March | |||
|---|---|---|---|
| (thousands of €) | 2021 | 2020 | |
| Current financial investments | 2,560,743 | 2,978,805 | |
| Cash and cash equivalents | 2,553,950 | 2,743,573 | |
| Current financial investments and cash and cash equivalents | 5,114,693 | 5,722,378 |
The accompanying notes form an integral part of these condensed consolidated financial statements.
Consolidated statements of changes in equity
| (thousands of €) | Share capital | Share premium account |
Translation differences |
Other reserves |
Accumul. Losses |
Total |
|---|---|---|---|---|---|---|
| On 1 January 2020 | 287,282 | 2,703,583 | (1,142) | (4,842) | (109,223) | 2,875,658 |
| Net loss | (50,601) | (50,601) | ||||
| Other comprehensive income/loss (–) |
478 | (77) | 401 | |||
| Total comprehensive income/loss (–) |
478 | (77) | (50,601) | (50,200) | ||
| Share-based compensation | 9,227 | 9,227 | ||||
| Exercise of subscription rights | 824 | 4,531 | 5,355 | |||
| On 31 March 2020 | 288,106 | 2,708,114 | (663) | (4,919) | (150,597) | 2,840,041 |
| On 1 January 2021 | 291,312 | 2,727,840 | (3,189) | (10,907) | (334,701) | 2,670,355 |
| Net profit | 9,361 | 9,361 | ||||
| Other comprehensive income | 822 | 207 | 1,029 | |||
| Total comprehensive income | 822 | 207 | 9,361 | 10,390 | ||
| Share-based compensation | 18,459 | 18,459 | ||||
| Exercise of subscription rights | 540 | 1,718 | 2,258 | |||
| On 31 March 2021 | 291,852 | 2,729,558 | (2,367) | (10,700) | (306,881) | 2,701,462 |
The accompanying notes form an integral part of these condensed consolidated financial statements.
Notes to the unaudited condensed consolidated interim financial statements for the first three 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.
The condensed consolidated interim financial statements were subject to a review by the statutory auditor, but have not been audited.
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.
We refer to the section Covid-19 impact in this Q1 report for a comprehensive overview of the impact of Covid-19 on the business evolution of Galapagos.
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 31 December 2020.
New standards and interpretations applicable for the annual period beginning on 1 January 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.
Details of the unaudited condensed consolidated interim results
Revenues and other income
Revenues
The following table summarizes our revenues for the three months ended 31 March 2021 and 2020.
| Three months ended 31 March | ||||
|---|---|---|---|---|
| (thousands of €) | Over time | Point in time | 2021 | 2020 |
| Recognition of non-refundable upfront payments and license fees |
105,226 | 88,287 | ||
| Gilead collaboration agreement for filgotinib | 47,405 | 32,105 | ||
| Gilead collaboration agreement for drug discovery platform | 57,821 | 56,182 | ||
| Milestone payments | 7,865 | 3,272 | ||
| Gilead collaboration agreement for filgotinib | 7,865 | 3,272 | ||
| Reimbursement income | - | 3,193 | ||
| Novartis collaboration agreement for MOR106 | - | 3,193 | ||
| Other revenues | 43 | 66 | ||
| Other revenues | 43 | 66 | ||
| Commercial revenues | 758 | - | ||
| Sale of goods | 79 | - | ||
| Royalties | 678 | - | ||
| Total revenues | 113,892 | 94,817 |
Revenues (€113.9 million for the first three months of 2021, compared to €94.8 million for the first three months of 2020) 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 €55.3 million for the first three months of 2021 (€35.4 million for the same period last year). The increased cost share and the additional upfront consideration as a consequence of the renegotiated arrangement between Gilead and Galapagos in December 2020, as well as the milestones for the approval of filgotinib in Europe and Japan achieved in the third quarter of 2020, all contributed to this increase in revenues.
FINANCIAL STATEMENTS
The rollforward of the outstanding balance of the current and non-current deferred income between 1 January 2021 and 31 March 2021 can be summarized as follows:
| (thousands of €) | Total | Gilead colla boration agreement for filgotinib |
Gilead colla boration agreement for drug discovery platform(1) |
Other deferred income (grants) |
|---|---|---|---|---|
| On 31 December 2020 | 2,809,133 | 818,654 | 1,990,412 | 67 |
| Significant financing component(2) | 2,447 | 2,447 | ||
| Revenue recognition of upfront payments |
(105,226) | (47,405) | (57,821) | |
| Revenue recognition of milestone payments |
(7,865) | (7,865) | ||
| Other movements | (67) | (67) | ||
| On 31 March 2021 | 2,698,417 | 765,829 | 1,932,589 | - |
(1) The outstanding balance at 31 March 2021 and at 31 December 2020 comprises the issuance liability for the 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.
Other income
Other income (€10.3 million for the first three months of 2021, compared to €8.7 million for the first three months of 2020) increased by €1.6 million, mainly driven by higher incentives income from the government for R&D activities.
Results from continuing operations
We realized a net loss from continuing operations of €12.8 million for the first three months of 2021, compared to a net loss of €52.3 million in the first three months of 2020.
We reported an operating loss amounting to €50.8 million for the first three months of 2021, compared to an operating loss of €46.2 million for the same period last year.
Our R&D expenditure in the first three months of 2021 amounted to €130.0 million, compared to €115.5 million in the first three months of 2020. This increase was due to an increase of €3.4 million in subcontracting costs primarily related to our filgotinib program, our Toledo program and other clinical programs, compensated by a decrease for ziritaxestat, the OA program with GLPG1972 and the AtD program with MOR106. Furthermore, personnel costs increased by €10.1 million from €30.3 million in the first three months of 2020 to €40.4 million in the first three months of 2021. This increase is explained by a planned headcount increase and increased costs of the subscription right plans.
FINANCIAL STATEMENTS
The table below summarizes our R&D expenditure for the three months ended 31 March 2021 and 2020, broken down by program.
| Three months ended 31 March | |||
|---|---|---|---|
| (thousands of €) | 2021 | 2020 | |
| Filgotinib program | (36,932) | (29,296) | |
| Ziritaxestat program | (10,513) | (13,783) | |
| OA program with GLPG1972 | (636) | (6,427) | |
| Toledo program | (27,823) | (16,871) | |
| AtD program with MOR106 | (152) | (4,248) | |
| Other programs | (53,904) | (44,828) | |
| Total research and development expenditure | (129,960) | (115,453) |
Our G&A and S&M expenses were €45.0 million in the first three months of 2021, compared to €34.3 million in the first three months of 2020. This increase mainly resulted from higher personnel costs for €9.6 million (€26.5 million in the first three months of 2021 compared to €16.9 million in the same period last year). This increase was due to a planned headcount increase following the commercial launch of filgotinib in Europe as well as higher costs of the subscription right plans.
In the first three months of 2021, we reported a non-cash fair value gain from the re-measurement of initial warrant B issued to Gilead, amounting to €2.0 million, mainly due to the decreased implied volatility of the Galapagos share price as well as its evolution between 31 December 2020 and 31 March 2021.
Net other financial income in the first three months of 2021 amounted to €36.2 million (as compared to €14.8 million in the same period last year), which was primarily attributable to €45.5 million of currency exchange gains on our cash and cash equivalents and current financial investments in U.S. dollars (as compared to €34.3 million in the first three months of 2020) and €3.6 million negative changes in (fair) value of current financial investments (€14.5 million in the same period last year). The other financial expenses also contained the effect of discounting our long term deferred income for €2.4 million (€4.4 million in the same period last year) and the fair value loss of financial assets held at fair value through profit or loss of €2.9 million (€2.7 million in the same period last year).
Cash position
Cash and cash equivalents and current financial investments totaled €5,114.7 million on 31 March 2021 (€5,169.3 million on 31 December 2020, including the cash and cash equivalents included in the assets classified as held for sale).
A net decrease of €54.6 million in cash and cash equivalents and current financial investments was recorded during the first three months of 2021, compared to a net decrease of €58.4 million during the first three months of 2020. This net decrease was composed of (i) €127.7 million of operational cash burn, (ii) offset by €2.3 million of cash proceeds from capital and share premium increase from exercise of subscription rights in the first three months of 2021, (iii) €3.6 million of negative changes in (fair) value of current financial investments and €45.7 million of mainly positive exchange rate differences, and (iv) €28.7 million cash in from disposal of subsidiaries, net of cash disposed 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 (–)/operational cash flow:
| Three months ended 31 March | |||
|---|---|---|---|
| (thousands of €) | 2021 | 2020 | |
| Increase in cash and cash equivalents (excluding effect of exchange differences) | 379,129 | 864,695 | |
| Less: | |||
| Net proceeds from capital and share premium increases | (2,258) | (5,355) | |
| Net sale of current financial investments | (475,844) | (942,738) | |
| Cash in from disposal of subsidiaries, net of cash disposed of | (28,696) | - | |
| Total operational cash burn | (127,669) | (83,398) |
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 three months while monitoring all liquidity aspects. Cash and cash equivalents comprised €1,358.0 million of term deposits which all had an original maturity longer than three months. All cash and cash equivalents are available upon maximum three months notice period and without significant penalty. Cash at banks were mainly composed of notice accounts and term deposits. Our credit risk is mitigated by selecting a panel of highly rated financial institutions for our deposits.
Cash invested in highly liquid money market funds represented €1,107.4 million (€1,571.9 million on 31 December 2020) and are presented as current financial investments on 31 March 2021. The current financial investments also include treasury bills, amounting to €1,453.3 million on 31 March 2021 (€1,454.4 million on 31 December 2020). Our portfolio of treasury bills contains only AAA rated paper, issued by Germany and The Netherlands. Our money market funds portfolio consists of AAA short-term money market funds with a diversified and highly rated underlying portfolio managed by established fund management companies with a proven track record leading to an insignificant risk of changes in value.
| 31 March | 31 December | |
|---|---|---|
| (thousands of €) | 2021 | 2020 |
| Cash at banks | 1,195,911 | 1,239,993 |
| Term deposits | 1,358,039 | 895,194 |
| Cash and cash equivalents from continuing operations | 2,553,950 | 2,135,187 |
| Cash and cash equivalents included in assets classified as held for sale | - | 7,884 |
| Total cash and cash equivalents | 2,553,950 | 2,143,071 |
On 31 March 2021, our cash and cash equivalents and current financial investments included \$1,007.9 million held in U.S. dollars (\$1,418.9 million on 31 December 2020) which could generate foreign exchange gains or losses in our financial results in accordance with the fluctuation of the EUR/U.S. dollar exchange rate as our functional currency is EUR. The foreign exchange loss (–)/gain in case of a 10% change in the EUR/U.S. dollar exchange rate amounts to €86.0 million.
Finally, our balance sheet held R&D incentives receivables from the French government (Crédit d'Impôt Recherche), to be received in four yearly tranches, and R&D incentives receivables from the Belgian Government, for a total of €142.3 million as at 31 March 2021.
Capital increase
On 31 March 2021, Galapagos NV's share capital was represented by 65,511,581 shares. All shares were issued, fully paid up and of the same class. The below table summarizes our capital increases for the period ended 31 March 2021.
| (thousands of €, except share data) |
Number of shares |
Share capital | Share premium |
Share capital and share premium |
Average exercise price subscription rights (in €/sub scription right) |
Closing share price on date of capital increase (in €/share) |
|---|---|---|---|---|---|---|
| On 1 January 2021 | 65,411,767 | 291,312 | 2,727,840 | 3,019,153 | ||
| 19 March 2021: exercise of subscription rights |
99,814 | 540 | 1,718 | 2,258 | 22.62 | 68.48 |
| On 31 March 2021 | 65,511,581 | 291,852 | 2,729,558 | 3,021,411 |
FINANCIAL STATEMENTS
Note to the cash flow statement
| Three months ended 31 March | |||
|---|---|---|---|
| (thousands of €) | 2021 | 2020 | |
| Adjustment for non-cash transactions | |||
| Depreciation and amortization | 5,019 | 4,189 | |
| Share-based compensation expenses | 18,459 | 9,227 | |
| Increase in retirement benefit obligations and provisions | 95 | 90 | |
| Unrealized exchange gains (–)/losses and non-cash other financial result | (38,515) | (32,856) | |
| Discounting effect of deferred income | 2,447 | 4,435 | |
| Fair value re-measurement of warrants | (1,970) | 20,529 | |
| Net change in (fair) value of current financial investments | 3,572 | 14,507 | |
| Fair value adjustment financial assets held at fair value through profit or loss | 2,913 | 2,745 | |
| Other non-cash expenses | - | 70 | |
| Total adjustment for non-cash transactions | (7,980) | 22,935 | |
| Adjustment for items to disclose separately under operating cash flow | |||
| Interest expense | 1,375 | 1,007 | |
| Interest income | (740) | (2,090) | |
| Tax expense | 157 | 336 | |
| Total adjustment for items to disclose separately under operating cash flow | 792 | (747) | |
| Adjustment for items to disclose under investing and financing cash flows | |||
| Gain on disposal of subsidiaries | (22,191) | - | |
| Realized exchange gain on sale of current financial investments | (6,645) | - | |
| Interest income on current financial assets | (6) | (2,596) | |
| Total adjustment for items to disclose separately under investing and financing cash flow |
(28,842) | (2,596) | |
| Change in working capital other than deferred income | |||
| Increase in inventories | (300) | (62) | |
| Decrease in receivables | 31,883 | 27,581 | |
| Increase/decrease (–) in liabilities | (11,911) | 24,962 | |
| Total change in working capital other than deferred income | 19,673 | 52,481 |
Fair value re-measurements
Gilead warrants B
The issuance of initial warrant B was approved on 22 October 2019 by the extraordinary general meeting of shareholders and is not yet exercised by Gilead at 31 March 2021. Initial warrant B has been valued on the basis of a Longstaff-Schwartz Monte Carlo model. The input data used in the model were derived from market observations (volatility, discount rate and share price) and from management estimates (number of shares to be issued and applied discount for lack of marketability). The recognized fair value gain of €2.0 million was mainly the result of a decrease in the implied volatility of our share price as well as its evolution between 31 December 2020 and 31 March 2021. The fair value of the financial liability related to the initial warrant B amounted to €1.2 million on 31 March 2021 and was presented as a current financial instrument.
Subsequent warrant B is still subject to approval by an extraordinary general meeting of shareholders and is therefore still presented as issuance liability in our deferred income.
Discontinued operations
The following disclosure illustrates the result of our discontinued operations, related to the sale of our fee-forservice business (Fidelta) to Selvita on 4 January 2021.
1. Disposal of subsidiaries (discontinued operations)
| 1.1. Consideration received | |
|---|---|
| (thousands of €) | 4 January 2021 |
| Consideration received in cash and cash equivalents | 37,080 |
| Total consideration received | 37,080 |
1.2. Analysis of assets and liabilities over which control was lost
| (thousands of €) | 4 January 2021 |
|---|---|
| Intangible assets | 21 |
| Property, plant and equipment | 10,050 |
| Other non-current assets | 160 |
| Trade and other receivables | 4,428 |
| Cash and cash equivalents | 7,884 |
| Other current assets | 863 |
| Total assets | 23,406 |
| Non-current lease liabilities | 4,115 |
| Other non-current liabilities | 70 |
| Trade and other liabilities | 4,479 |
| Current lease liabilities | 727 |
| Income tax payable | 356 |
| Total liabilities | 9,747 |
| Net assets disposed of | 13,658 |
1.3. Gain on disposal of subsidiaries
| (thousands of €) | |
|---|---|
| Consideration received | 37,080 |
| Net assets disposed of | (13,658) |
| Effect of cumulative translation adjustments reclassified from equity on loss of control | (731) |
| Costs associated to the sale | (500) |
| Gain on disposal | 22,191 |
FINANCIAL STATEMENTS
1.4. Net cash inflow on disposal of subsidiaries
| (thousands of €) | |
|---|---|
| Consideration received in cash and cash equivalents | 37,080 |
| Less: cash and cash equivalents balances disposed of | (7,884) |
| Total consideration received, net of cash disposed of | 29,196 |
| Costs associated to the sale | (500) |
| Cash in from disposal of subsidiaries, net of cash disposed of | 28,696 |
2. Result from discontinued operations
| Three months ended 31 March | ||||
|---|---|---|---|---|
| (thousands of €, except share and per share data) | 2021 | 2020 | ||
| Revenues | - | 3,356 | ||
| Other income | - | - | ||
| Total revenues and other income | - | 3,356 | ||
| Gain on disposal of subsidiaries | 22,191 | |||
| Research and development expenditure | - | (1,310) | ||
| Sales and marketing expenses | - | |||
| General and administrative expenses | - | (413) | ||
| Total operating expenses | - | (1,723) | ||
| Operating profit | 22,191 | 1,633 | ||
| Other financial income | - | 40 | ||
| Other financial expenses | - | (16) | ||
| Profit before tax | 22,191 | 1,657 | ||
| Income taxes | - | - | ||
| Net profit | 22,191 | 1,657 | ||
| Basic income per share from discontinued operations | 0.34 | 0.03 | ||
| Diluted income per share from discontinued operations | 0.34 | 0.02 | ||
| Weighted average number of shares - Basic (in thousands of shares) | 65,425 | 64,690 | ||
| Weighted average number of shares - Diluted (in thousands of shares) | 65,944 | 68,123 |
3. Cash flows from discontinued operations
| Three months ended 31 March | |||
|---|---|---|---|
| (thousands of €) | 2021 | 2020 | |
| Net cash flows generated from operating activities | - | 1,998 | |
| Net cash flows generated from/used in (-) investing activities | 28,696 | (447) | |
| Net cash flows used in financing activities | - | (183) | |
| Net cash flows from discontinued operations | 28,696 | 1,368 |
Contingencies and commitments
Contractual obligations and commitments
We have certain purchase commitments principally with CRO subcontractors and certain collaboration partners.
On 31 March 2021, we had outstanding obligations for purchase commitments, which become due as follows:
| (thousands of €) | Total | Less than 1 year |
1 – 3 years | 3 – 5 years | More than 5 years |
|---|---|---|---|---|---|
| Purchase commitments | 319,267 | 252,913 | 52,599 | 13,093 | 662 |
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 €482.8 million at 31 March 2021 for which we have direct purchase commitments of €23.5 million at 31 March 2021 reflected in the table above.
Contingent liabilities and assets
We refer to our Annual Report 2020 for a description of our contingent liabilities and assets.
Events after the end of the reporting period
On 30 April 2021, the supervisory board of Galapagos approved "Subscription Right Plan 2021 RMV", a subscription right plan intended for the employees of its French subsidiary, Galapagos SASU, "Subscription Right Plan 2021 ROW", a subscription right plan intended for the employees of its other non-Belgian subsidiairies and "Subscription Right Plan 2021 BE", a subscription right plan intended for the employees of the company and its Belgian subsidiaries, within the framework of the authorized capital. Under these subscription right plans, 2,736,250 subscription rights were created, subject to acceptances, and offered to the beneficiaries of the plans. The subscription rights have an exercise term of eight years as of the date of the offer and have an exercise price of €64.76 (the closing price of the share on Euronext Amsterdam and Brussels on the day preceding the date of the offer). The subscription rights are not transferable. Subscription rights granted under Subscription Right Plan 2021 BE can in principle not be exercised prior to 1 January 2025 and subscription rights granted under Subscription Right Plan 2021 RMV and Subscription Right Plan 2021 ROW vest in instalments: with 25% of each grant being exercisable as of 1 January 2023, 25% as of 1 January 2024 and 50% (the remainder) as of 1 January 2025. Each subscription right gives the right to subscribe to one new Galapagos share.
We note that Dr. Rajesh Parekh and Ms. Katrine Bosley were re-appointed as members of the supervisory board by the shareholders' meeting of 28 April 2021 for a period of four years and for a period of one year respectively. Ms. Katrine Bosley is an independent supervisory board member within the meaning of article 7:87 of the Belgian Companies Code and article 3.5 of the Belgian Corporate Governance Code 2020.
Approval of interim financial statements
The interim financial statements were approved by the management board on 5 May 2021.
Report on the review of the condensed consolidated interim financial statements for the three-month period ended 31 March 2021
The original text of this report is in Dutch
In the context of our appointment as the company's statutory auditor, we report to you on the condensed consolidated interim financial statements. These condensed consolidated interim financial statements comprise the consolidated statements of financial position as at 31 March 2021, the consolidated statements of income and comprehensive income / loss (-), the consolidated statements of changes in equity and the consolidated cash flow statements for the period of three months then ended, as well as selective notes.
Report on the condensed consolidated interim financial statements
We have reviewed the condensed consolidated interim financial statements of Galapagos NV ("the company") and its subsidiaries (jointly "the group"), prepared in accordance with International Accounting Standard (IAS) 34, "Interim Financial Reporting" as adopted by the European Union.
The consolidated statement of financial position shows total assets of 5 615 059 (000) EUR and the consolidated income statement shows a consolidated profit (group share) for the period then ended of 9 361 (000) EUR.
The management board of the company is responsible for the preparation and fair presentation of the condensed consolidated interim financial statements in accordance with IAS 34, "Interim Financial Reporting" as adopted by the European Union. Our responsibility is to express a conclusion on these condensed consolidated interim financial statements based on our review.
Scope of review
We conducted our review of the condensed consolidated interim financial statements in accordance with International Standard on Review Engagements (ISRE) 2410, "Review of interim financial information performed by the independent auditor of the entity". A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit performed in accordance with the International Standards on Auditing (ISA) and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion on the condensed consolidated interim financial statements.
Conclusion
Based on our review, nothing has come to our attention that causes us to believe that the condensed consolidated interim financial statements of Galapagos NV have not been prepared, in all material respects, in accordance with IAS 34, "Interim Financial Reporting" as adopted by the European Union.
Signed at Zaventem, 6 May 2021. The statutory auditor
Deloitte Bedrijfsrevisoren/Réviseurs d'Entreprises BV/SRL
Represented by Nico Houthaeve
Glossary of terms
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
Ankylosing spondylitis (AS)
AS is a systemic, chronic, and progressive spondyoloarthropathy primarily affecting the spine and sacroiliac joints, and progressing into severe inflammation that fuses the spine, leading to permanent painful stiffness of the back
Anti-TNF
Tumor necrosis factor. An anti-TNF drug acts by modulation of TNF
Assays
Laboratory tests to determine characteristics
ATS
ATS, the American Thoracic Society improves global health by advancing research, patient care, and public health in pulmonary disease, critical illness, and sleep disorders
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
Autotaxin (ATX)
An enzyme important for generating the signaling molecule lypophosphatidic acid (LPA). Ziritaxestat targets autotaxin for IPF and SSc
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 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 subscription rights
Bleomycin model
A preclinical model involving use of bleomycin (a cancer medication) to induce IPF symptoms
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
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 first shows efficacy in a therapeutic setting
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
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
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
DLCO
DLCO (diffusion capacity of the lung for carbon monoxide) is the extent to which oxygen passes from the air sacs of the lungs into the blood. This is measured in IPF patients
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
Esbriet
An approved drug (pirfenidone) for IPF, marketed by Roche
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
Fibrotic score
The Ashcroft fibrotic score involves measuring pulmonary fibrosis through examination of histopathology tissue
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
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
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 Commission
FRI
Functional respiratory imaging is a technology which enhances 3D visualization and quantification of a patient's airway and lung geometry
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
FVC
Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC is used to help determine both the presence and severity of lung diseases such as IPF
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/SIK3 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
GLPG1205
A GPR84 inhibitor discovered by us. Development of GLPG1205 was deprioritized in 2021
GLPG1690
Autotaxin inhibitor discovered by us and 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 retained rights outside of CF
GLPG3121
A compound currently in Phase 1 targeting JAK1/TYK2 directed toward inflammation
GLPG3667
A TYK2 kinase inhibitor discovered by us, currently in Phase 1b in psoriasis
GLPG3970
A SIK2/SIK3 inhibitor currently in multiple Phase 2 Proof of Concept studies. Currently the lead molecule in the Toledo program
GLPG4059
A compound currently in Phase 1 with undisclosed mode of action directed toward metabolic diseases. Development of GLPG4059 was deprioritized in 2021
GLPG4399
A SIK3 inhibitor currently in the preclinical phase 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/SIK3 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/SIK3 inhibitor in the preclinical phase, currently directed toward inflammation. This molecule was selected for acceleration in 2021
GPR84 inhibitor
Drug candidate aimed at inhibiting or blocking G-protein coupled receptor 84. GLPG1205 is a GPR84 inhibitor aimed at IPF
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
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
Inspiratory capacity
Total lung capacity or the amount of gas contained in the lung at the end of a maximal inhalation
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
ISABELA
Phase 3 clinical program investigating ziritaxestat in IPF patients. All development with ziritaxestat was discontinued in February 2021
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 preferential 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
MACE
Major adverse cardiovascular events; a composite endpoint frequently used in cardiovascular research
MANTA
A Phase 2 semen parameter trial with filgotinib in male patients with CD or UC
MANTA-RAy
Phase 2 semen parameter trial with filgotinib in male patients with RA, PsA, or AS
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
Ofev
An approved drug (nintedanib) for IPF, marketed by Boehringer Ingelheim
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
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
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-controlled
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
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 embolism
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 and Exchange Commission in the US
SELECTION
Phase 3 program evaluating filgotinib in UC patients
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
Sjögrens 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 2 Proof of Concept trial with SIK2/SIK3 inhibitor GLPG3970 in SLE
Target
Proteïn 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
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
Financial calendar
05 August 2021
Half year 2021 results
04 November 2021
Third quarter 2021 results
24 February 2022
Full year 2021 results
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: 6 May 2021
This report is also available in Dutch and available for download in the Downloads section of this report or at www.glpg.com
OTHER INFORMATION
Contact
Elizabeth Goodwin Vice President Investor Relations Galapagos NV 230 Third Ave Waltham, MA 02451, United States Tel. +1 781 460 1784 Email: [email protected]
Sofie Van Gijsel Senior Director Investor Relations Galapagos NV Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium Tel. +32 485 19 14 15
Sandra Cauwenberghs Director of Investor Relations Galapagos NV Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium Tel. +32 15 34 29 00
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: [email protected]
Kyra Obolensky Senior Director Corporate Communications Galapagos NV Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium Tel. +32 491 92 64 35