Lakefront Biotherapeutics NV 6-K, filed Nov 7, 2022
Lakefront Biotherapeutics NV (LKFT)
About this 6-K
Lakefront Biotherapeutics NV filed this 6-K on November 7, 2022.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of November 2022
Commission File Number: 001-37384
GALAPAGOS NV
(Translation of registrant’s name into English)
Generaal De Wittelaan L11 A3
2800 Mechelen, Belgium
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Third Quarter 2022 Results
On November 3, 2022, Galapagos NV, or the Registrant, announced its unaudited third quarter results for 2022, which are further described in the Registrant’s Q3 2022 report, a copy of which is attached hereto as Exhibit 99.2.
| Exhibit |
Description | |
| 99.1 | Press Release dated November 3, 2022 | |
| 99.2 | Q3 Report 2022 | |
The information contained in this Report on Form 6-K, including the exhibits, except for the quotes of Paul Stoffels and the quote of Bart Filius contained in Exhibit 99.1, is hereby incorporated by reference into the Company’s Registration Statements on Form S-8 (File Nos. 333-204567, 333-208697, 333-211834, 333-215783, 333-218160, 333-225263, 333-231765, 333-249416 and 333-260500).
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| GALAPAGOS NV | ||||||
| (Registrant) | ||||||
| Date: November 7, 2022 | /s/ Annelies Denecker | |||||
| Annelies Denecker | ||||||
| Company Secretary | ||||||
Exhibit 99.1
Galapagos announces strategy to accelerate innovation and reports strong third quarter 2022 results
| • | Clear path forward for accelerated growth and value creation |
| • | Reshape innovation model and build fit-for-purpose organization in key strategic therapeutic areas: immunology and oncology |
| • | Jyseleca® 2022 net sales guidance further increased to €80-€90 million from €75-€85 million at H1 2022 |
| • | First nine months 2022 financial results: |
| • | Strong performance of Jyseleca franchise with €60.5 million in net sales |
| • | Group revenues of €410.2 million |
| • | Operating loss of €135.1 million |
| • | Cash and current financial investments of €4.4 billion on 30 September |
R&D and Strategy Webcast presentation at R&D Update tomorrow in New York, 4 November 2022, 13.00 – 15.30 CET / 8 am – 10.30 am EDT, www.glpg.com
Mechelen, Belgium; 3 November 2022, 21.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) today announced its strategy for accelerated growth and value creation, its financial results for the first nine months of 2022, and the outlook for the remainder of 2022. The results are further detailed in the Q3 2022 financial report available on the financial reports section of the website.
Forward, Faster strategy to accelerate innovation
“Guided by our purpose to bring transformational medicines to patients around the world to help them live longer and healthier lives, we today announce our Forward, Faster strategy to accelerate growth and value creation by reshaping the way we innovate and operate. This strategy provides a clear path forward based on three key pillars. First, we will shift from novel target-based discovery to patient-centric medical need research and development with a focus on our key therapeutic areas of immunology and oncology. Second, we will build on our current capabilities and derisk R&D through multiple drug modalities, including CAR-T, and by focusing on best-in-disease validated targets in our strategic therapeutic areas with shorter time-to-patient potential. Third, we will increase our business development efforts to complement our pipeline and continue to work with our collaboration partner Gilead to bring more medicines to patients worldwide,” said Dr. Paul Stoffels1, CEO and Chairman of the Board of Directors of Galapagos.
“Our new fit-for-purpose organizational structure and operating model will focus on accelerating our pipeline in immunology and oncology, supported by externally sourced opportunities, and we will discontinue our activities in fibrosis and kidney disease2.
As a result of our new strategic direction, we intend to reduce our workforce by approximately 200 positions across our sites in Europe to create room to reinvest in new capabilities and programs in our oncology franchise. This is a difficult but necessary decision, and we will follow all applicable processes with respect for our people.
| 1 | Acting via Stoffels IMC BV |
| 2 | The study with ‘2737 in polycystic kidney disease is ongoing with topline results expected in the first half of 2023. If successful, we aim to outlicense the program. |
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Third quarter financial performance
“Jyseleca continues to perform very well with a growing European base and a solid €60.5 million in net sales as of 30 September. As a result, we further increase our 2022 net sales guidance to €80-€90 million from our initial guidance of €65-€75 million. We ended the third quarter of the year with a strong balance sheet of €4.4 billion in cash and current financial investments, which provides us with the necessary means to invest in immunology and oncology and execute on smart business development. We reiterate our cash burni guidance of €480-€520 million for the full year 2022,” added Bart Filius, President, COO and CFO of Galapagos.”
Q3 2022 operational review and recent events
Jyseleca commercial & regulatory progress
| • | Strong adoption across Europe with reimbursement for rheumatoid arthritis (RA) in 15 countries and for ulcerative colitis (UC) in 10 countries |
| • | Marketing Authorization Application (MAA) submitted for the treatment of UC to Swissmedic, the regulatory authority in Switzerland |
| • | Article 20 pharmacovigilance procedure ongoing by the European Medicines Agency (EMA) |
Pipeline update
| • | Preparations advanced to start Phase 2 of GLPG3667 (TYK2 inhibitor) in dermatomyositis, with the aim to recruit the first patients around year-end |
Corporate update
| • | Received various transparency notifications from FMR LLC, indicating that its shareholding in Galapagos changed, without crossing below the 5% threshold, to 5.65% of the current outstanding Galapagos shares |
| • | Raised €6.7 million year-to-date through the exercise of subscription rights |
Post-period events
| • | On 27 October 2022, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded the safety review (Article 20 procedure) of all JAK inhibitors approved in the EU for the treatment of inflammatory diseases. On 28 October 2022, the PRAC recommended the harmonization of all labels and concluded that JAK inhibitors should remain indicated for the treatment of patients with RA who have responded inadequately to or who cannot tolerate disease modifying anti-rheumatic drugs (DMARDs) therapy, and for patients with UC who have responded inadequately to or who cannot tolerate conventional therapy or biologics. The PRAC also recommended to update all product labels to include a precautionary approach for use of JAK inhibitors in patients with identified risk factors only if no suitable treatment alternative is available (Section 4.4—Warning and Precautions). The PRAC recommendations will now be considered by the Committee for Medicinal Products for Human Use (CHMP) for an opinion |
| • | Abstract accepted for poster presentation at the Annual Society of Hematology (ASH) conference taking place 10-13 December 2022 on the initial data from the ATALANTA-1 Phase 1/2 study in recurring/refractory Non-Hodgkin Lymphoma (rrNHL) evaluating the feasibility, safety and efficacy of the CD19 CAR-T candidate manufactured at point-of-care |
| • | New post hoc analyses from SELECTION Phase 3 data set with filgotinib in UC patients presented at the United European Gastroenterology (UEG) Week |
| • | Received positive CHMP opinion for Jyseleca European label update based on testicular function safety data from MANTA/RAy studies |
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Financial highlights for the first nine months of 2022 (unaudited)
(€ millions, except basic & diluted loss per share)
| 30 September 2022 group total |
30 September 2021 group total |
Variance | ||||||||||
| Product net sales |
60.5 | 6.1 | 54.3 | |||||||||
| Collaboration revenues |
349.7 | 311.7 | 38.0 | |||||||||
| Total net revenues |
410.2 | 317.9 | 92.3 | |||||||||
| Cost of sales |
(7.9 | ) | (0.7 | ) | (7.3 | ) | ||||||
| R&D expenditure |
(364.1 | ) | (378.0 | ) | 14.0 | |||||||
| G&Aii and S&Miii expenses |
(202.7 | ) | (151.3 | ) | (51.4 | ) | ||||||
| Other operating income |
29.5 | 36.3 | (6.9 | ) | ||||||||
| Operating loss |
(135.1 | ) | (175.7 | ) | 40.7 | |||||||
| Net financial result |
127.5 | 33.6 | 93.8 | |||||||||
| Income taxes |
(3.2 | ) | 0.3 | (3.5 | ) | |||||||
| Net loss from continuing operations |
(10.8 | ) | (141.8 | ) | 131.0 | |||||||
| Net profit from discontinued operations |
— | 22.2 | (22.2 | ) | ||||||||
| Net loss of the period |
(10.8 | ) | (119.6 | ) | 108.8 | |||||||
| Basic and diluted loss per share (€) |
(0.16 | ) | (1.83 | ) | ||||||||
| Basic and diluted loss per share from continuing operations (€) |
(0.16 | ) | (2.16 | ) | ||||||||
| Current financial investments and cash and cash equivalents |
4,362.1 | 4,874.2 | ||||||||||
Q3 2022 financial results
We reported product net sales of Jyseleca in Europe for the first nine months of 2022 amounting to €60.5 million (€6.1 million in the first nine months of 2021). Our counterparties for the sales of Jyseleca were mainly hospitals and wholesalers located across Europe.
Cost of sales related to Jyseleca net sales in the first nine months of 2022 amounted to €7.9 million.
Collaboration revenues amounted to €349.7 million for the first nine months of 2022, compared to €311.7 million for the first nine months of 2021.
Revenues recognized related to the collaboration agreement with Gilead for the filgotinib development were €166.8 million in the first nine months of 2022 compared to €136.4 million for the same period last year. This increase was due to a higher increase in the percentage of completion, as well as a higher revenue recognition of milestone payments, strongly influenced by the milestone achieved related to the regulatory approval in Japan for UC in the first nine months of 2022. The revenue recognition related to the exclusive access rights for Gilead to our drug discovery platform amounted to €172.6 million for the first nine months of 2022 (€173.3 million for the same period last year).
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We have recognized royalty income from Gilead for Jyseleca for €8.2 million in the first nine months of 2022 (compared to €1.9 million in the same period last year) of which €3.6 million royalties on milestone income for UC approval in Japan.
Additionally, we recorded milestones of €2.0 million triggered by the first sales of Jyseleca in the Czech Republic and Portugal by our distribution and commercialization partner Sobi, in the first nine months of 2022.
Our deferred income balance on 30 September 2022 includes €1.6 billion allocated to our drug discovery platform that is recognized linearly over the remaining period of our 10-year collaboration, and €0.5 billion allocated to the filgotinib development that is recognized over time until the end of the development period.
Our R&D expenditure in the first nine months of 2022 amounted to €364.1 million, compared to €378.0 million for the first nine months of 2021. This decrease was primarily explained by a decrease in subcontracting costs from €189.1 million in the first nine months of 2021 to €158.5 million in the first nine months of 2022, primarily due to the winding down of the ziritaxestat (IPF) program and reduced spend on our SIKi and TYK2 programs. This was partly offset by cost increases for our filgotinib program, on a nine month basis compared to the same period in 2021. Personnel costs decreased from €134.3 million in the first nine months of 2021 to €130.0 million for the same period this year. Depreciation and impairment amounted to €35.6 million for the first nine months of 2022 (€14.1 million for the same period last year). This increase was primarily due to an impairment of €26.7 million of previously capitalized upfront fees related to our collaboration with Molecure on the dual chitinase inhibitor OATD-01 (GLPG4716) recorded in Q2 2022.
Our G&A and S&M expenses amounted to €202.7 million in the first nine months of 2022, compared to €151.3 million in the first nine months of 2021. This increase was primarily due to the termination of our 50/50 filgotinib co-commercialization cost sharing agreement with Gilead for filgotinib in 2022. The cost increase was also explained by an increase in personnel costs for the first nine months of 2022 compared to the same period last year explained by an increase in the commercial work force driven by the commercial launch of filgotinib in Europe.
Other operating income (€29.5 million vs €36.3 million for the same period last year) decreased, mainly driven by lower grant and R&D incentives income.
Net financial income in the first nine months of 2022 amounted to €127.5 million, compared to net financial income of €33.6 million for the first nine months of 2021. Net financial income in the first nine months of 2022 was primarily attributable to €102.1 million of unrealized currency exchange gains on our cash and cash equivalents and current financial investments at amortized cost in U.S. dollars, and to €26.0 million of positive changes in (fair) value of current financial investments. The financial expenses also contained the effect of discounting our long term deferred income of €5.7 million.
We realized a net loss from continuing operations of €10.8 million for the first nine months of 2022, compared to a net loss of €141.8 million for the first nine months of 2021.
The net profit from discontinued operations for the nine months ended 30 September 2021 consisted of the gain on the sale of Fidelta, our fee-for-services business, for €22.2 million.
We reported a group net loss for the first nine months of 2022 of €10.8 million, compared to a group net loss of €119.6 million for the first nine months of 2021.
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Cash position
Current financial investments and cash and cash equivalents totaled €4,362.1 million on 30 September 2022, as compared to €4,703.2 million on 31 December 2021.
Total net decrease in cash and cash equivalents and current financial investments amounted to €341.1 million during the first nine months of 2022, compared to a net decrease of €295.2 million during the first nine months of 2021. This net decrease was composed of (i) €343.1 million of operational cash burn, (ii) offset by €6.7 million of cash proceeds from capital and share premium increase from exercise of subscription rights in the first nine months of 2022, (iii) €26.0 million positive changes in (fair) value of current financial investments and €105.6 million of mainly positive exchange rate differences, and (iv) the cash out from the acquisitions of CellPoint and AboundBio, net of cash acquired, of €136.4 million.
Acquisitions of CellPoint and AboundBio
The preliminary accounting of the acquisitions of CellPoint and AboundBio are included in our Q3 2022 condensed consolidated financial statements. To date, we have performed a preliminary fair value analysis of the business combinations. We expect the provisional amount of goodwill to change significantly upon the completion of the purchase price allocation, resulting from the valuation of the different assets and liabilities acquired.
Near term outlook
Immunology – an area in which we have built deep scientific know-how and expertise since our founding
We expect reimbursement decisions in most key European markets for Jyseleca in UC this year and anticipate that Sobi will further progress with reimbursement discussions in RA and UC in Eastern and Central Europe, Greece, and the Baltic countries. We also expect to report initial results from the FILOSOPHY Real-World Evidence Phase 4 trial in RA later this year, and topline results from the DIVERSITY Phase 3 study in Crohn’s disease (CD) in the first quarter of 2023. Before the end of this year, we anticipate a CHMP opinion following the PRAC Article 20 recommendation issued on 28 October 2022.
We aim to recruit the first patients in a Phase 2 study of our TYK2 inhibitor product candidate, GLPG3667, in dermatomyositis around year-end, and we intend to start a Phase 2 study in patients with Systemic Lupus Erythematosus (SLE) in 2023. Finally, we continue to advance select compounds with optimized pharmacology and selectivity from our SIKi portfolio.
Oncology portfolio – an area where we will continue to grow and invest
We will present the initial data from the ATALANTA-1 Phase 1/2 study of the CD19 CAR-T product candidate in patients with rrNHL at the annual ASH conference in December. The objectives of the ATALANTA-1 study are to evaluate the feasibility, safety and efficacy of the CD19 CAR-T candidate manufactured at point-of-care and will provide initial clinical validation of the CAR-T decentralized supply model.
The recruitment of the ongoing Phase 1/2 studies of the CD19 CAR-T candidate in patients with rrNHL (ATALANTA study) and relapsed/refractory Chronic Lymphocytic Leukemia (rrCLL) (EUPLAGIA study) is progressing well, and we are on track to report topline results of the dose escalation cohorts in the first half of 2023, which will be followed by one or more dose expansion cohorts.
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Financial guidance and Forward, Faster strategy presentation
For the full year 2022, we reiterate our net cash burn of €480-€520 million, including the acceleration in oncology, and we further increase our net sales guidance for Jyseleca to €80-€90 million.
A detailed update of the strategy, portfolio and pipeline goals and commercial progress will be presented by Galapagos management and key opinion leaders at the company’s R&D Day 2022 which will be held tomorrow, Friday, 4 November 2022, from 8:00 am to 10:30 am EDT (13:00 to 15:30 CET) in New York.
The event will include a live webcast on the Investors section of the company’s website and a replay will be available on the Galapagos website within 48 hours after the event. Presentations showcased during the event will be featured on the Presentations section of the company’s website.
To participate in the conference call, please register in advance using this link. Upon registration, the dial-in numbers will be provided. The conference call can be accessed 10 minutes prior to the start time by using the conference access information provided in the e-mail received at the point of registering, or by selecting the call me feature.
Third quarter 2022 financial report
Galapagos’ financial report for the first nine months ended 30 September 2022, including details of the unaudited consolidated results, is accessible on the financial reports section of our website.
Financial calendar 2023
| 23 February 2023 |
Full year 2022 results |
(webcast 24 February 2023) | ||
| 23 March 2023 |
Annual report 2022 |
|||
| 25 April 2023 |
Annual Shareholders’ meeting |
|||
| 4 May 2023 |
First quarter 2023 results |
(webcast 5 May 2023) | ||
| 3 August 2023 |
Half year 2023 results |
(webcast 4 August 2023) | ||
| 2 November 2023 |
Third quarter 2023 results |
(webcast 3 November 2023) |
About Galapagos
Galapagos is a fully integrated biotechnology company focused on discovering, developing, and commercializing innovative medicines. We are committed to improving patients’ lives worldwide by targeting diseases with high unmet needs. Our R&D capabilities cover multiple drug modalities, including small molecules and cell therapies. Our portfolio comprises discovery through to Phase 4 programs in immunology, oncology, and other indications. Our first medicine for rheumatoid arthritis and ulcerative colitis is available in the European Union, Norway, Great Britain, and Japan. For additional information, please visit www.glpg.com or follow us on LinkedIn or Twitter.
Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies. Except for filgotinib’s approval as Jyseleca for the treatment of moderately to severely RA and UC by the relevant regulatory authorities in the European Union, Great Britain, and Japan, our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.
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Contact
Investors:
Sofie Van Gijsel
Head of Investor Relations
+1 781 296 1143
Sandra Cauwenberghs
Director Investor Relations
+32 495 58 46 63
ir@glpg.com
Media:
Marieke Vermeersch
Head of Corporate Communication
+32 479 490 603
media@glpg.com
Forward-looking statements
This press release contains forward-looking statements, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “upcoming,” “future,” “estimate,” “may,” “will,” “could,” “would,” “potential,” “forward,” “goal,” “next,” “stand to,” “continue,” “should,” “encouraging,” “aim,” “explore,” “further” as well as similar expressions. These statements include, but are not limited to, statements made in the sections captioned “Q3 2022 operational review and recent events” and “Near term outlook”, the guidance from management (including the guidance regarding the expected operational use of cash during the 2022 fiscal year, the expected financial results and our strategic and capital allocation priorities), statements regarding the acquisitions of CellPoint and AboundBio, including statements regarding anticipated benefits of the acquisitions and the integration of CellPoint and AboundBio into our portfolio and strategic plans, statements regarding our regulatory and R&D outlook, statements regarding expected financial results, statements regarding the amount and timing of potential future milestones, opt-in and/or royalty payments, our R&D strategy, including progress on our immunology or oncology portfolio or our SIKi platform, and potential changes in such strategy, statements regarding our pipeline and complementary technology platforms driving future growth, statements regarding the strategic re-evaluation, statements regarding our expectations on commercial sales of filgotinib, statements regarding the global R&D collaboration with Gilead and the amendment of our arrangement with Gilead for the commercialization and development of filgotinib, statements regarding the expected timing, design and readouts of ongoing and planned clinical trials, including recruitment for trials and topline results for trials and studies in our portfolio, statements regarding the expected topline results from the DIVERSITY Phase 3 study in CD, statements related to the EMA’s safety review of JAK inhibitors used to treat certain inflammatory disorders, including filgotinib, initiated at the request of the European Commission (EC) under article 20 of Regulation (EC) No 726/2004, 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 other indications for filgotinib in Europe, Great Britain, Japan, and the U.S., such additional regulatory authorities requiring additional studies, the timing or likelihood of pricing and reimbursement interactions for filgotinib, statements relating to the build-up of our commercial organization, commercial sales for filgotinib and rollout in Europe, statements related to the expected reimbursement for Jyseleca, and statements regarding our strategy (including our strategic transformation exercise), portfolio goals, business plans, focus, and plans for a sustainable future. We caution the reader that forward-looking statements are based on our management’s current expectations and beliefs and are not guarantees of future performance. Forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause our actual results, financial condition and liquidity, performance or achievements, or the industry in which we operate, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Such risks include, but are not limited to, the risk that our expectations regarding our 2022 revenues and financial results or our 2022 operating expenses may be incorrect (including because one or more of our assumptions underlying our revenue or expense expectations may not be realized), the risk that ongoing and future clinical trials may not be completed in the currently envisaged timelines or at all, the inherent risks and uncertainties associated with competitive development, clinical trial, recruitment of patients for trials and product development activities and regulatory approval requirements (including, but not limited to, the risk that data from our ongoing and planned clinical research programs in RA, rrNHL, rrCLL, CD, UC, other immunologic indications or other indications or diseases, may not support registration or further development of our product candidates due to safety, or efficacy concerns, or other reasons), risks related to the acquisitions of CellPoint and AboundBio, including the risk that we may not achieve the anticipated benefits of the acquisitions of CellPoint and AboundBio, the inherent risks and uncertainties associated with target discovery and validation and drug discovery and development activities, risks related to our reliance on collaborations with third parties (including our collaboration partner for filgotinib, Gilead), risks related to the
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implementation of the transition of the European commercialization responsibility of filgotinib from Gilead to us, the risk that the transition will not be completed on the currently contemplated timeline or at all, including the transition of the supply chain, and the risk that the transition will not have the currently expected results for our business and results of operations, estimating the commercial potential of our product candidates and our expectations regarding the costs and revenues associated with the transfer of the European commercialization rights to filgotinib may be incorrect, the risk that we will not be able to continue to execute on our currently contemplated business plan and/or will revise our business plan, including the risk that our plans with respect to CAR-T may not be achieved on the currently anticipated timeline or at all, the risk that our projections and expectations regarding the commercial potential of our product candidates or expectations regarding the costs and revenues associated with the commercialization rights may be inaccurate, the risks related to our strategic transformation exercise, including the risk that we may not achieve the anticipated benefits of such exercise on the currently envisaged timeline or at all, the risk that we will encounter challenges retaining or attracting talent, risks related to disruption in our operations, supply chain or ongoing studies (including our DIVERSITY 1 study) due to the conflict between Russia and Ukraine, the risks related to continued regulatory review of filgotinib following approval by relevant regulatory authorities and the EMA’s safety review of JAK inhibitors used to treat certain inflammatory disorders, including the risk that the EMA and/or other regulatory authorities determine that additional non-clinical or clinical studies are required with respect to filgotinib, the risk that the EMA may require that the market authorization for filgotinib in the EU be amended, the risk that the EMA may impose JAK class-based warnings, the risk that the EMA’s safety review may negatively impact acceptance of filgotinib by patients, the medical community, and healthcare payors and the risks and uncertainties related 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 filings and reports with the Securities and Exchange Commission (SEC), including in our most recent annual report on Form 20-F filed with the SEC and our subsequent filings and reports filed with the SEC. Given these risks and uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. In addition, even if the result of our operations, financial condition and liquidity, or the industry in which we operate, are consistent with such forward-looking statements, they may not be predictive of results, performance or achievements in future periods. These forward-looking statements speak only as of the date of publication of this release. We expressly disclaim any obligation to update any such forward-looking statements in this release to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
| i | The operational cash burn (or operational cash flow if this liquidity measure is positive) is equal to the increase or decrease in our cash and cash equivalents (excluding the effect of exchange rate differences on cash and cash equivalents), minus: |
| • | the net proceeds, if any, from share capital and share premium increases included in the net cash flows generated from/used in (-) financing activities |
| • | the net proceeds or cash used, if any, related to the acquisitions or disposals of businesses; the movement in restricted cash and movement in current financial investments, if any, the cash advances and loans given to third parties, if any, included in the net cash flows generated from/used in (-) investing activities |
| • | the cash used for other liabilities related to the acquisition of businesses, if any, included in the net cash flows generated from/used in (-) operating activities. |
This alternative liquidity measure is in our view an important metric for a biotech company in the development stage. The operational cash burn for the nine months ended 30 September 2022 amounted to €343.1 million and can be reconciled to our cash flow statement by considering the decrease in cash and cash equivalents of €1,583.9 million, adjusted by (i) the cash proceeds from capital and share premium increase from the exercise of subscription rights by employees for €6.7 million, (ii) the net purchase of current financial investments amounting to €1,111.1 million, and (iii) the cash out from acquisition of subsidiaries, net of cash acquired, of €136.4 million
| ii | General and administrative |
| iii | Sales and marketing |
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Exhibit 99.2
Q3 Report 2022 Foundation & Future Galapagos Pioneering for patients
Table of Contents The Galapagos group Letter from our CEO 4 Q3 2022 operational review 5 Post-period events 5 Near term outlook 6 Financial highlights 8 The Galapagos share 14 Potential external impacts 15 Risk factors 16 Disclaimer and other information 17 Financial statements Unaudited condensed consolidated interim financial statements 21 Notes 30 Other information Glossary 45 Financial calendar 62 Colophon 63 Contact 64 TABLE OF CONTENTS Galapagos Q3 Report 2022 2
Galapagos group An overview of Galapagos, its strategy and portfolio in the first nine months of 2022 Foundation & Future
When Galapagos was founded more than two decades ago, we set out to discover new medicines with novel modes of action. By applying our deep scientific expertise and disease pathway knowledge, we identified new targets and successfully brought a novel medicine to market. We are very proud of how far we have come and what we have achieved, demonstrated by the successful launch of our first medicine Jyseleca in Europe. Guided by our purpose to bring transformational medicines to patients around the world to help them live longer and healthier lives, we are today announcing our Forward, Faster strategy to accelerate growth and value creation by reshaping the way we innovate and operate. This new strategic direction is based on three key pillars. First, we will shift from novel target-based discovery to patient-centric medical need research and development with a focus on our key therapeutic areas of immunology and oncology. Second, we will build on our current capabilities and de-risk R&D through multiple drug modalities, including CAR-T and by focusing on best-indisease validated targets in our strategic therapeutic areas with shorter time-to-patient potential. Third, we will increase our business development efforts to complement our pipeline and continue to work with our collaboration partner Gilead to bring more medicines to patients worldwide. Our new fit-for-purpose organizational structure and operating model will focus on accelerating our pipelines in immunology and oncology, supported by externally sourced opportunities. And we will discontinue our activities in fibrosis and kidney disease 1. As a result of our new strategic direction, we intend to reduce our workforce by approximately 200 positions across our sites in Europe to create room to reinvest in new capabilities and programs in our oncology franchise. This is a difficult but necessary decision and we will follow all applicable processes with respect for our people. We have a clear path forward for accelerated growth and value creation for all our stakeholders. Respectfully, Dr. Paul Stoffels 2 CEO and Chairman of the Board of Directors Letter from our CEO The study with ‘2737 in polycystic kidney disease is ongoing with topline results expected in the first half of 2023. If successful, we aim to outlicense the program. 1 2 Acting via Stoffels IMC BV THE GALAPAGOS GROUP Galapagos Q3 Report 2022 4
Q3 2022 operational review Jyseleca commercial & regulatory progress Strong adoption across Europe with reimbursement for rheumatoid arthritis (RA) in 15 countries and for ulcerative colitis (UC) in 10 countries Marketing Authorization Application (MAA) submitted for the treatment of UC to Swissmedic, the regulatory authority in Switzerland Article 20 pharmacovigilance procedure ongoing by the European Medicines Agency (EMA) Pipeline update Preparations advanced to start Phase 2 of GLPG3667 (TYK2 inhibitor) in dermatomyositis, with the aim to recruit the first patients around year-end Corporate update Received various transparency notifications from FMR LLC, indicating that its shareholding in Galapagos changed, without crossing below the 5% threshold, to 5.65% of the current outstanding Galapagos shares Raised €6.7 million year-to-date through the exercise of subscription rights Post-period events On 27 October 2022, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded the safety review (Article 20 procedure) of all JAK inhibitors approved in the EU for the treatment of inflammatory diseases. On 28 October 2022, the PRAC recommended the harmonization of all labels and concluded that JAK inhibitors should remain indicated for the treatment of patients with RA who have responded inadequately to or who cannot tolerate disease modifying anti-rheumatic drugs (DMARDs) therapy, and for patients with UC who have responded inadequately to or who cannot tolerate conventional therapy or biologics. The PRAC also recommended to update all product labels to include a precautionary approach for use of JAK inhibitors in patients with identified risk factors only if no suitable treatment alternative is available (Section 4.4—Warning and Precautions). The PRAC recommendations will now be considered by the Committee for Medicinal Products for Human Use (CHMP) for an opinion Abstract accepted for poster presentation at the Annual Society of Hematology (ASH) conference taking place 10-13 December 2022 on the initial data from the ATALANTA-1 Phase 1/2 study in recurring/refractory Non-Hodgkin Lymphoma (rrNHL) evaluating the feasibility, safety and efficacy of the CD19 CAR-T candidate manufactured at point-of-care THE GALAPAGOS GROUP Galapagos Q3 Report 2022 5
We expect reimbursement decisions in most key European markets for Jyseleca in UC this year and anticipate that Sobi will further progress with reimbursement discussions in RA and UC in Eastern and Central Europe, Greece, and the Baltic countries. We also expect to report initial results from the FILOSOPHY Real-World Evidence Phase 4 trial in RA later this year, and topline results from the DIVERSITY Phase 3 study in Crohn’s disease (CD) in the first quarter of 2023. Before the end of this year, we anticipate a CHMP opinion following the PRAC Article 20 recommendation issued on 28 October 2022. We aim to recruit the first patients in a Phase 2 study of our TYK2 inhibitor product candidate, GLPG3667, in dermatomyositis around year-end, and we intend to start a Phase 2 study in patients with Systemic Lupus Erythematosus (SLE) in 2023. Finally, we continue to advance select compounds with optimized pharmacology and selectivity from our SIKi portfolio. We will present the initial data from the ATALANTA-1 Phase 1/2 study of the CD19 CAR-T product candidate in patients with rrNHL at the annual ASH conference in December. The objectives of the ATALANTA-1 study are to evaluate the feasibility, safety and efficacy of the CD19 CAR-T candidate manufactured at point-of-care and will provide initial clinical validation of the CAR-T decentralized supply model. The recruitment of the ongoing Phase 1/2 studies of the CD19 CAR-T candidate in patients with rrNHL (ATALANTA study) and recurring/refractory Chronic Lymphocytic Leukemia (rrCLL) (EUPLAGIA study) is progressing well, and we are on track to report topline results of the dose escalation cohorts in the first half of 2023, which will be followed by one or more dose expansion cohorts. New post hoc analyses from SELECTION Phase 3 data set with filgotinib in UC patients presented at the United European Gastroenterology (UEG) Week Received positive CHMP opinion for Jyseleca European label update based on testicular function safety data from MANTA/RAy studies Near term outlook Immunology—an area in which we have built deep scientific know-how and expertise since our founding Oncology—an area where we will continue to grow and invest THE GALAPAGOS GROUP Galapagos Q3 Report 2022 6
For the full year 2022, we reiterate our net cash burn of €480-€520 million, including the acceleration in oncology, and we further increase our net sales guidance for Jyseleca to €80-€90 million. A detailed update of the strategy, portfolio and pipeline goals will be presented by Galapagos management and key opinion leaders at the company’s R&D Day which will be held tomorrow, Friday, 4 November 2022, from 8:00 am to 10:30 am EDT (13:00 to 15:30 CET) in New York. The event will include a live video stream on the Investors section of the company’s website and a replay will be available on the Galapagos website within 48 hours after the event. Presentations showcased during the event will be featured on the Presentations section of the company’s website. Financial guidance and Forward, Faster strategy presentation THE GALAPAGOS GROUP Galapagos Q3 Report 2022 7
Consolidated Key Figures (thousands of €, if not stated otherwise) Third quarter of 2022 Third quarter of 2021 Nine months ended 30 September 2022 Nine months ended 30 September 2021 Year ended 31 December 2021 Income statement Product net sales 25,135 5,691 60,491 6,147 14,753 Collaboration revenues 111,068 58,503 349,669 311,711 470,093 Cost of sales (2,393) (529) (7,938) (660) (1,629) R&D expenditure (114,549) (109,196) (364,067) (378,022) (491,707) S&M, G&A expenses (68,677) (45,448) (202,686) (151,267) (210,855) Other operating income 11,837 12,781 29,474 36,345 53,749 Operating loss (37,578) (78,199) (135,056) (175,747) (165,596) Net financial results 59,825 13,743 127,501 33,659 42,598 Taxes (694) (157) (3,229) 316 (2,423) Net profit/loss (-) from continuing operations 21,554 (64,613) (10,784) (141,772) (125,422) Net profit from discontinued operations, net of tax 22,191 22,191 Net profit/loss (-) 21,554 (64,613) (10,784) (119,581) (103,231) Financial highlights THE GALAPAGOS GROUP Galapagos Q3 Report 2022 8
(thousands of €, if not stated otherwise) Third quarter of 2022 Third quarter of 2021 Nine months ended 30 September 2022 Nine months ended 30 September 2021 Year ended 31 December 2021 Balance sheet Cash and cash equivalents 675,519 2,834,378 675,519 2,834,378 2,233,368 Current financial investments 3,686,557 2,039,787 3,686,557 2,039,787 2,469,809 R&D incentives receivables 153,460 149,271 153,460 149,271 144,013 Assets 4,972,070 5,331,987 4,972,070 5,331,987 5,193,160 Shareholders’ equity 2,690,351 2,617,383 2,690,351 2,617,383 2,643,362 Deferred income 2,052,686 2,520,652 2,052,686 2,520,652 2,364,701 Other liabilities 229,033 193,952 229,033 193,952 185,097 Cash flow Operational cash burn (125,979) (153,546) (343,081) (376,743) (564,840) Cash flow used in operating activities (116,942) (136,925) (320,682) (340,056) (503,827) Cash flow generated from/used in (-) investing activities (182,568) 311,138 (1,263,625) 993,191 541,238 Cash flow generated from/used in (-) financing activities 793 (964) 432 (2,438) (3,876) Increase/decrease (-) in cash and cash equivalents (298,716) 173,249 (1,583,875) 650,697 33,535 Effect of currency exchange rate fluctuation on cash and cash equivalents 1,440 18,489 26,026 40,610 56,763 Cash and cash equivalents at the end of the period 675,519 2,834,378 675,519 2,834,378 2,233,368 Current financial investments at the end of the period 3,686,557 2,039,787 3,686,557 2,039,787 2,469,809 Total current financial investments and cash and cash equivalents at the end of the period 4,362,076 4,874,165 4,362,076 4,874,165 4,703,177 THE GALAPAGOS GROUP Galapagos Q3 Report 2022 9
(thousands of €, if not stated otherwise) Third quarter of 2022 Third quarter of 2021 Nine months ended 30 September 2022 Nine months ended 30 September 2021 Year ended 31 December 2021 Financial ratios Number of shares issued at the end of the period 65,835,511 65,530,121 65,835,511 65,530,121 65,552,721 Basic and diluted income/loss (-) per share 0.33 (0.99) (0.16) (1.83) (1.58) Share price at the end of the period (in €) 43.92 45.16 43.92 45.16 49.22 Total group employees at the end of the period (number) 1,357 1,319 1,357 1,319 1,309 (total: 1,357 employees) Employees per site as of 30 September 2022 THE GALAPAGOS GROUP Galapagos Q3 Report 2022 10
We reported product net sales of Jyseleca in Europe for the first nine months of 2022 amounting to €60.5 million (€6.1 million in the first nine months of 2021). Our counterparties for the sales of Jyseleca were mainly hospitals and wholesalers located across Europe. Cost of sales related to Jyseleca net sales in the first nine months of 2022 amounted to €7.9 million. Collaboration revenues amounted to €349.7 million for the first nine months of 2022, compared to €311.7 million for the first nine months of 2021. Revenues recognized related to the collaboration agreement with Gilead for the filgotinib development were €166.8 million in the first nine months of 2022 compared to €136.4 million for the same period last year. This increase was due to a higher increase in the percentage of completion, as well as a higher revenue recognition of milestone payments strongly influenced by the milestone achieved related to the regulatory approval in Japan for UC in the first nine months of 2022. The revenue recognition related to the exclusive access rights for Gilead to our drug discovery platform amounted to €172.6 million for the first nine months of 2022 (€173.3 million for the same period last year). We have recognized royalty income from Gilead for Jyseleca for €8.2 million in the first nine months of 2022 (compared to €1.9 million in the same period last year) of which €3.6 million royalties on milestone income for UC approval in Japan. Additionally, we recorded milestones of €2.0 million triggered by the first sales of Jyseleca in Czech Republic and Portugal by our distribution and commercialization partner Sobi, in the first nine months of 2022. Our deferred income balance on 30 September 2022 includes €1.6 billion allocated to our drug discovery platform that is recognized linearly over the remaining period of our 10 year collaboration, and €0.5 billion allocated to filgotinib development that is recognized over time until the end of the development period. Our R&D expenditure in the first nine months of 2022 amounted to €364.1 million, compared to €378.0 million for the first nine months of 2021. This decrease was primarily explained by a decrease in subcontracting costs from €189.1 million in the first nine months of 2021 to €158.5 million in the first nine months of 2022, primarily due to the winding down of the ziritaxestat (IPF) program and reduced spend on our SIKi and TYK2 programs. This was partly offset by cost increases for our filgotinib program, on a nine month basis compared to the same period in 2021. Personnel costs decreased from €134.3 million in the first nine months of 2021 to €130.0 million for the same period this year. Depreciation and impairment amounted to €35.6 million for the first nine months of 2022 (€14.1 million for the same period last year). This increase was primarily due to an impairment of €26.7 million of previously capitalized upfront fees related to our collaboration with Molecure on the dual chitinase inhibitor OATD-01 (GLPG4716), recorded in Q2 2022. Q3 2022 financial results THE GALAPAGOS GROUP Galapagos Q3 Report 2022 11
Our S&M expenses were €105.3 million in the first nine months of 2022, compared to €46.6 million in the first nine months of 2021. This increase was primarily due to the termination of our 50/50 filgotinib co-commercialization cost sharing agreement with Gilead. The cost increase was also explained by an increase in personnel costs (€53.4 million for the first nine months of 2022 compared to €43.3 million for the same period last year) explained by an increase in the commercial work force from 234 average FTEs in the first nine months of 2021 to 304 average FTEs in the first nine months of 2022 driven by the commercial launch of filgotinib in Europe. Our G&A expenses were €97.4 million in the first nine months of 2022, compared to €104.7 million in the first nine months of 2021. The cost decrease was primarily due to the impairment of €9.3 million on other tangible assets recorded in the first nine months of 2021 following our decision to reassess the construction project of our new future headquarter location in Mechelen (Belgium). Personnel costs amounted to €54.5 million for the first nine months of 2022 compared to €52.4 million for the same period last year. Other operating income (€29.5 million for the first nine months of 2022, compared to €36.3 million for the first nine months of 2021) decreased by €6.9 million, mainly driven by lower grant and R&D incentive income. We reported an operating loss amounting to €135.1 million for the first nine months of 2022, compared to an operating loss of €175.7 million for the same period last year. Net financial income in the first nine months of 2022 amounted to €127.5 million (as compared to net financial income of €33.6 million in the same period last year). Net financial income in the first nine months of 2022 was primarily attributable to €102.1 million of unrealized currency exchange gain on our cash and cash equivalents and current financial investments at amortized cost in U.S. dollar (as compared to €54.9 million currency exchange gain on cash and cash equivalents and current financial investments in the first nine months of 2021) and €26.0 million positive changes in (fair) value of current financial investments (€7.2 million negative changes in the same period last year). The other financial expenses also contained the discounting effect of our long term deferred income of €5.7 million (€7.2 million in the same period last year). Net interest income amounted to €3.3 million in the first nine months of 2022 (compared to net interest cost of €6.3 million in the same period last year), due to increasing interest rates. The fair value loss of financial assets held at fair value through profit or loss amounted to nil in the first nine months in 2022 (as compared to €2.9 million in the same period last year). We realized a net loss from continuing operations of €10.8 million for the first nine months of 2022, compared to a net loss of €141.8 million for the first nine months of 2021. The net profit from discontinued operations for the first nine months of 2021 consisted of the gain on the sale of Fidelta, our fee-for-services business, for €22.2 million. We reported a group net loss for the first nine months of 2022 of €10.8 million, compared to a group net loss of €119.6 million for the same period last year. THE GALAPAGOS GROUP Galapagos Q3 Report 2022 12
Cash and cash equivalents and current financial investments totaled €4,362.1 million on 30 September 2022 (€4,703.2 million on 31 December 2021). A net decrease of €341.1 million in cash and cash equivalents and current financial investments was recorded during the first nine months of 2022, compared to a net decrease of €295.2 million during the first nine months of 2021. This net decrease was composed of (i) €343.1 million of operational cash burn, (ii) offset by €6.7 million of cash proceeds from capital and share premium increases from exercise of subscription rights in the first nine months of 2022, (iii) €26.0 million of positive changes in (fair) value of current financial investments and €105.6 million of mainly positive exchange rate differences, and (iv) €136.4 million cash out from the acquisitions of CellPoint and AboundBio, net of cash acquired. The operational cash burn (or operational cash flow if this liquidity 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, the loans and advances given to third parties, if any, included in the net cash flows generated from/used in (–) investing activities iii. the cash used for other liabilities related to the acquisition of businesses, if any, included in the net cash flows generated from/used in (–) operating activities. This alternative liquidity measure is in our view an important metric for a biotech company in the development stage. Cash, cash equivalents and current financial investments THE GALAPAGOS GROUP Galapagos Q3 Report 2022 13
The following table provides a reconciliation of the operational cash burn: Nine months ended 30 September (thousands of €) 2022 2021 Increase/decrease (-) in cash and cash equivalents (excluding effect of exchange differences) (1,583,875) 650,697 Less: Net proceeds from capital and share premium increases (6,695) (2,735) Net purchase/sale (-) of current financial investments 1,111,139 (996,008) Cash out from acquisition of subsidiaries, net of cash acquired 115,270 - Cash advances and loans to third parties 10,000 - Cash used for other liabilities related to the acquisition of subsidiaries 11,080 - Cash in from disposals of subsidiaries, net of cash disposed of - (28,696) Total operational cash burn (343,081) (376,743) The Galapagos share Performance of the Galapagos share on Euronext and Nasdaq THE GALAPAGOS GROUP Galapagos Q3 Report 2022 14
Whilst the beginning of 2022 was globally marked by steeply increasing infection rates mainly due to the spread of the highly infectious Omicron-variant, the situation improved significantly during the second and third quarter and the strict measures taken by local governments to help prevent the spread of the COVID-19 virus and protect the physical and mental health of our staff could gradually be loosened. We nevertheless continue to monitor COVID-19 infection rates at global and local levels, and have systems in place to react quicky where needed to guarantee business continuity. We report the following impacts: Potential external impacts COVID-19 Staff At Galapagos, we maintained the measures put in place by local governments to help prevent the spread of the COVID-19 virus and protect the physical and mental health of our staff, albeit that these measures were gradually loosened during 2022. The majority of our research staff continued to work from the office/labs. For teleworkable functions we continued the implementation of our hybrid working model launched in 2021, in locations where the ongoing COVID-19 situation and corresponding local governmental measures permitted us to do so. For those employees coming to the office, we maintained stringent cleaning and sanitation protocols. We further kept our global and site-specific business continuity plans up-to-date and continued to take appropriate recommended precautions. 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 COVID-19 pandemic and the associated specific regulatory, institutional, government guidance and policies related to COVID-19. Within the boundaries of these guidelines and policies, and in consultation with our contract research organizations (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 were 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, amongst 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 to mitigate its effect on the study where necessary and to facilitate the interpretation and reporting of results. THE GALAPAGOS GROUP Galapagos Q3 Report 2022 15
We refer to the description of risk factors in our 2021 annual report, pp. 57-69, 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. 6-50. In summary of the foregoing, the principal risks and uncertainties faced by us, relate to and include, but are not limited 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 pandemics 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 2021 annual report, pp. 250-254, which remains valid and unaltered. 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, and thus became partially virtual. The teams invested in digital channels as part of the overall commercial build strategy, and these channels are being utilized during our ongoing commercial launch. Thus far we note no material impact on the relative competitiveness of our commercial operations due to travel restrictions, nor have the effects of COVID-19 impacted our ability to engage in market access discussions. Nevertheless, healthcare systems are under pressure across Europe, increasing the volatility in reimbursement procedures and cost containment measures, and potentially reducing the number of new therapy options initiated by healthcare providers. Conflict in Ukraine The armed conflict between Russia and Ukraine could cause a material disruption in our operations. We currently have ongoing clinical studies for filgotinib with CROs located in Ukraine and Russia. If our CROs experience disruptions to their business due to the military conflict in Ukraine and the sanctions against Russia, it could result in delays in our clinical development activities, including delay of our clinical development plans and timelines, or could cause interruptions in operations of regulatory authorities. The impact on ongoing pivotal studies such as DIVERSITY 1 has remained limited. We continue to monitor the situation and are taking measures to mitigate the impact on our ability to conduct clinical development activities. Interruptions or delays in our and our CROs’ ability to meet expected clinical development deadlines or to comply with contractual commitments with respect to the same, could lead to delays in our overall developmental and commercialization timelines, which would adversely impact our ability to conduct clinical development activities and complete them on a timely basis. Since 24 February 2022, we have extended the focus of the business continuity plan to closely monitor each program in context of the currently ongoing Ukraine-Russia conflict and the associated specific regulatory, institutional, and government guidance and policies. Risk factors THE GALAPAGOS GROUP Galapagos Q3 Report 2022 16
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 as Jyseleca® for the treatment of rheumatoid arthritis (RA) and ulcerative colitis (UC) by the European Commission, Great Britain’s Medicines and Healthcare products Regulatory Agency and Japanese Ministry of Health, Labour and Welfare, our drug candidates mentioned in this report are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority. This report is published in Dutch and in English. In case of inconsistency between the Dutch and English versions, the Dutch version shall prevail. Galapagos will use reasonable efforts to ensure the translation and conformity between the Dutch and English versions. This report is available free of charge and upon request addressed to: Galapagos NV Investor Relations Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium Tel: +32 15 34 29 00 Email: ir@glpg.com A digital version of this report is available on our website, www.glpg.com. We will use reasonable efforts to ensure the accuracy of the digital version, but 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. Euronext Amsterdam and Brussels: GLPG Nasdaq: GLPG 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 Disclaimer and other information Listings Forward-looking statements THE GALAPAGOS GROUP Galapagos Q3 Report 2022 17
or phrases such as “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “upcoming,” “future,” “estimate,” “may,” “will,” “could,” “would,” “potential,” “forward,” “goal,” “next,” “stand to,” “continue,” “should,” “encouraging,” “aim,” “explore,” “further” as well as similar expressions. Forward-looking statements contained in this report include, but are not limited to, statements made in the section captioned “Letter from our CEO” of this report, the information provided in the section captioned “Near term outlook” of this report, the guidance from management regarding the expected operational use of cash during the 2022 fiscal year, statements regarding our strategic and capital allocation priorities, statements regarding the acquisitions of CellPoint and AboundBio, including statements regarding anticipated benefits of the acquisitions and the integration of CellPoint and AboundBio into our portfolio and strategic plans, statements regarding our regulatory and R&D outlook, statements regarding expected financial results, statements regarding the amount and timing of potential future milestones, opt-in and/or royalty payments, our R&D strategy, including progress on our immunology or oncology portfolio or our SIKi platform, and potential changes in such strategy, statements regarding our pipeline and complementary technology platforms driving future growth, statements regarding the strategic re-evaluation, statements regarding our expectations on commercial sales of filgotinib, statements regarding the global R&D collaboration with Gilead and the amendment of our arrangement with Gilead for the commercialization and development of filgotinib, statements regarding the expected timing, design and readouts of ongoing and planned clinical trials (i) with filgotinib in RA, UC and Crohn’s disease, (ii) with GLPG3667 in systemic lupus erythematosus and dermatomyositis, (iii) with compounds from our SIKi portfolio, (iv) with GLPG2737 in polycystic kidney disease, (v) with CD19 CAR-T in rrNHL and rrCLL, (vi) with the next-generation CARTs and bispecific antibodies, including recruitment for trials and topline results for trials and studies in CAR-T, and (vii) with expected topline results from the DIVERSITY Phase 3 study in CD, statements related to the EMA’s safety review of JAK inhibitors used to treat certain inflammatory disorders, including filgotinib, initiated at the request of the European Commission (EC) under article 20 of Regulation (EC) No 726/2004, 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 other indications for filgotinib in Europe, Great Britain, Japan, and the U.S., such additional regulatory authorities requiring additional studies, the timing or likelihood of pricing and reimbursement interactions for filgotinib, statements relating to the build-up of our commercial organization, commercial sales for filgotinib and rollout in Europe, statements related to the expected reimbursement for Jyseleca, statements regarding the effect of the conflict between Russia and Ukraine on our operations and ongoing studies (including the impact on our DIVERSITY 1 study), statements regarding the expected impact of COVID-19, and statements regarding our strategy (including our strategic transformation exercise), portfolio goals, business plans, focus, and plans for a sustainable future. We caution the reader that forward-looking statements are based on our management’s current expectations and beliefs, and are not guarantees of future performance. Forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause our actual results, financial condition and liquidity, performance or achievements, or the industry in which we operate, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Such risks include, but are not limited to, the risk that our beliefs, assumptions and expectations regarding our 2022 revenues and financial results or our 2022 operating expenses may be incorrect (including because one or more of our assumptions underlying our revenue or expense expectations may not be realized), the risk that ongoing and future clinical trials may not be completed in the currently envisaged timelines or at all, the inherent risks and uncertainties THE GALAPAGOS GROUP Galapagos Q3 Report 2022 18
associated with competitive developments, clinical trial, recruitment of patients for trials and product development activities and regulatory approval requirements (including, but not limited to, the risk that data from our ongoing and planned clinical research programs in RA, rrNHL, rrCLL, CD, UC, other immunologic indications or other indications or diseases, may not support registration or further development of our product candidates due to safety, or efficacy concerns, or other reasons), risks related to the acquisitions of CellPoint and AboundBio, including the risk that we may not achieve the anticipated benefits of the acquisitions of CellPoint and AboundBio, the inherent risks and uncertainties associated with target discovery and validation and drug discovery and development activities, risks related to our reliance on collaborations with third parties (including our collaboration partner for filgotinib, Gilead), risks related to the implementation of the transition of the European commercialization responsibility of filgotinib from Gilead to us, the risk that the transition will not be completed on the currently contemplated timeline or at all, including the transition of the supply chain, and the risk that the transition will not have the currently expected results for our business and results of operations, the risk that estimates regarding our filgotinib development program and the commercial potential of our product candidates and our expectations regarding the costs and revenues associated with the transfer of European commercialization rights to filgotinib may be incorrect, the risk that we will not be able to continue to execute on our currently contemplated business plan and/or will revise our business plan, including the risk that our plans with respect to CAR-T may not be achieved on the currently anticipated timeline or at all, the risk that our projections and expectations regarding the commercial potential of our product candidates or expectations regarding the costs and revenues associated with the commercialization rights may be inaccurate, the risks related to our strategic transformation exercise, including the risk that we may not achieve the anticipated benefits of such exercise on the currently envisaged timeline or at all, the risk that we will encounter challenges retaining or attracting talent, risks related to disruption in our operations or supply chain due to the conflict between Russia and Ukraine, the risks related to continued regulatory review of filgotinib following approval by relevant regulatory authorities and the EMA’s safety review of JAK inhibitors used to treat certain inflammatory disorders, including the risk that the EMA and/or other regulatory authorities determine that additional non-clinical or clinical studies are required with respect to filgotinib, the risk that the EMA may require that the market authorization for filgotinib in the EU be amended, the risk that the EMA may impose JAK class-based warnings, the risk that the EMA’s safety review may negatively impact acceptance of filgotinib by patients, the medical community, and healthcare payors and the risks and uncertainties related 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 filings and reports with the Securities and Exchange Commission (SEC), including in our most recent annual report on Form 20-F filed with the SEC and our subsequent filings and reports filed with the SEC. We also refer to the “Risk Factors” section of this report. Given these risks and uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. In addition, even if the result of our operations, financial condition and liquidity, or the industry in which we operate, are consistent with such forward-looking statements, they may not be predictive of results, performance or achievements in future periods. These forward-looking statements speak only as of the date of publication of this 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. THE GALAPAGOS GROUP Galapagos Q3 Report 2022 19
Unaudited condensed consolidated interim financial statements for the first nine months of 2022 Financial statements Foundation & Future
Consolidated income statement Third quarter of Nine months ended 30 September (thousands of €, except per share data) 2022 2021 2022 2021 Product net sales 25,135 5,691 60,491 6,147 Collaboration revenues 111,068 58,503 349,669 311,711 Total net revenues 136,203 64,194 410,160 317,858 Cost of sales (2,393) (529) (7,938) (660) Research and development expenditure (114,549) (109,196) (364,067) (378,022) Sales and marketing expenses (34,305) (17,655) (105,313) (46,616) General and administrative expenses (34,372) (27,793) (97,373) (104,651) Other operating income 11,837 12,781 29,474 36,345 Operating loss (37,578) (78,199) (135,056) (175,747) Fair value adjustments and net currency exchange differences 58,971 19,974 130,900 47,669 Other financial income 5,660 747 9,675 2,315 Other financial expenses (4,806) (6,978) (13,074) (16,325) Profit/loss (-) before tax 22,247 (64,456) (7,555) (142,088) Unaudited condensed consolidated interim financial statements for the first nine months of 2022 Consolidated statements of income and comprehensive income/loss (-) (unaudited) FINANCIAL STATEMENTS Galapagos Q3 Report 2022 21
Third quarter of Nine months ended 30 September (thousands of €, except per share data) 2022 2021 2022 2021 Income taxes (694) (157) (3,229) 316 Net profit/loss (-) from continuing operations 21,554 (64,613) (10,784) (141,772) Net profit from discontinued operations, net of tax 22,191 Net profit/loss (-) 21,554 (64,613) (10,784) (119,581) Net profit/loss (-) attributable to: Owners of the parent 21,554 (64,613) (10,784) (119,581) Basic and diluted income/loss (-) per share 0.33 (0.99) (0.16) (1.83) Basic and diluted income/loss (-) per share from continuing operations 0.33 (0.99) (0.16) (2.16) The accompanying notes form an integral part of these condensed consolidated financial statements. FINANCIAL STATEMENTS Galapagos Q3 Report 2022 22
Consolidated statement of comprehensive income/loss (–) Third quarter of Nine months ended 30 September (thousands of €) 2022 2021 2022 2021 Net profit/loss (-) 21,554 (64,613) (10,784) (119,581) Items that may be reclassified subsequently to profit or loss: Translation differences, arisen from translating foreign activities (100) (32) (7) 171 Realization of translation differences upon sale of foreign operations 731 Other comprehensive income/loss (-), net of income tax (100) (32) (7) 902 Total comprehensive income/loss (-) attributable to: Owners of the parent 21,454 (64,645) (10,791) (118,679) Total comprehensive income/loss (-) attributable to owners of the parent arises from: Continuing operations 21,454 (64,645) (10,791) (141,601) Discontinued operations 22,922 Total comprehensive income/loss (-) 21,454 (64,645) (10,791) (118,679) The accompanying notes form an integral part of these condensed consolidated financial statements. FINANCIAL STATEMENTS Galapagos Q3 Report 2022 23
30 September 31 December (thousands of €) 2022 2021 Assets Goodwill 174,994 - Intangible assets other than goodwill 38,493 60,103 Property, plant and equipment 150,394 137,512 Deferred tax assets 4,091 4,032 Non-current R&D incentives receivables 133,869 127,186 Other non-current assets 7,833 2,473 Non-current assets 509,673 331,306 Inventories 25,510 20,569 Trade and other receivables 34,783 111,337 Current R&D incentives receivables 19,591 16,827 Current financial investments 3,686,557 2,469,809 Cash and cash equivalents 675,519 2,233,368 Other current assets 20,436 9,945 Current assets 4,462,397 4,861,854 Total assets 4,972,070 5,193,160 Consolidated statements of financial position (unaudited) FINANCIAL STATEMENTS Galapagos Q3 Report 2022 24
30 September 31 December (thousands of €) 2022 2021 Equity and liabilities Share capital 293,605 292,075 Share premium account 2,735,557 2,730,391 Other reserves (10,860) (10,177) Translation differences (1,046) (1,722) Accumulated losses (326,905) (367,205) Total equity 2,690,351 2,643,362 Retirement benefit liabilities 12,521 11,699 Non-current lease liabilities 15,759 19,655 Other non-current liabilities 38,209 7,135 Non-current deferred income 1,683,023 1,944,836 Non-current liabilities 1,749,512 1,983,325 Current lease liabilities 6,926 7,204 Trade and other liabilities 154,745 137,622 Current tax payable 873 1,782 Current deferred income 369,663 419,866 Current liabilities 532,207 566,474 Total liabilities 2,281,719 2,549,798 Total equity and liabilities 4,972,070 5,193,160 The accompanying notes form an integral part of these condensed consolidated financial statements. FINANCIAL STATEMENTS Galapagos Q3 Report 2022 25
Nine months ended 30 September (thousands of €) 2022 2021 Net loss of the period (10,784) (119,581) Adjustment for non-cash transactions (25,707) 59,050 Adjustment for items to disclose separately under operating cash flow 1,599 6,013 Adjustment for items to disclose under investing and financing cash flows (1,700) (28,845) Change in working capital other than deferred income 57,472 46,642 Cash used for other liabilities related to the acquisition of subsidiaries (11,080) - Decrease in deferred income (318,167) (295,651) Cash used in operations (308,367) (332,372) Interest paid (10,940) (9,436) Interest received 2,262 2,049 Corporate taxes paid (3,637) (297) Net cash flows used in operating activities (320,682) (340,056) Consolidated cash flow statements (unaudited) FINANCIAL STATEMENTS Galapagos Q3 Report 2022 26
Nine months ended 30 September (thousands of €) 2022 2021 Purchase of property, plant and equipment (19,808) (33,907) Purchase of and expenditure in intangible fixed assets (9,308) (1,661) Proceeds from disposal of property, plant and equipment 719 - Purchase of current financial investments (2,505,688) (905,124) Interest received related to current financial investments 1,181 10 Sale of current financial investments 1,394,549 1,901,132 Cash in from disposals of subsidiaries, net of cash disposed of - 28,696 Cash out from acquisition of subsidiaries, net of cash acquired (115,270) - Cash advances and loans to third parties (10,000) - Proceeds from sale of financial assets held at fair value through profit or loss - 4,045 Net cash flows generated from/used in (-) investing activities (1,263,625) 993,191 Payment of lease liabilities (6,263) (5,174) Proceeds from capital and share premium increases from exercise of subscription rights 6,695 2,735 Net cash flows generated from/used in (-) financing activities 432 (2,438) Increase/decrease (-) in cash and cash equivalents (1,583,875) 650,697 FINANCIAL STATEMENTS Galapagos Q3 Report 2022 27
Nine months ended 30 September (thousands of €) 2022 2021 Cash and cash equivalents at beginning of year 2,233,368 2,143,071 Increase/decrease (-) in cash and cash equivalents (1,583,875) 650,697 Effect of exchange rate differences on cash and cash equivalents 26,026 40,610 Cash and cash equivalents at end of the period 675,519 2,834,378 The accompanying notes form an integral part of these condensed consolidated financial statements. 30 September (thousands of €) 2022 2021 Current financial investments 3,686,557 2,039,787 Cash and cash equivalents 675,519 2,834,378 Current financial investments and cash and cash equivalents 4,362,076 4,874,165 The accompanying notes form an integral part of these condensed consolidated financial statements. FINANCIAL STATEMENTS Galapagos Q3 Report 2022 28
(thousands of €) Share capital Share premium account Translation differences Other reserves Accumul. losses Total On 1 January 2021 291,312 2,727,840 (3,189) (10,907) (334,701) 2,670,355 Net loss (119,581) (119,581) Other comprehensive income 880 22 902 Total comprehensive income/loss (-) 880 22 (119,581) (118,679) Share-based compensation 62,971 62,971 Exercise of subscription rights 640 2,095 2,735 On 30 September 2021 291,953 2,729,935 (2,309) (10,885) (391,311) 2,617,383 On 1 January 2022 292,075 2,730,391 (1,722) (10,177) (367,205) 2,643,362 Net loss (10,784) (10,784) Other comprehensive income/loss (-) 676 (683) (7) Total comprehensive income/loss (-) 676 (683) (10,784) (10,791) Share-based compensation 51,085 51,085 Exercise of subscription rights 1,530 5,165 6,695 On 30 September 2022 293,605 2,735,557 (1,046) (10,860) (326,905) 2,690,351 The accompanying notes form an integral part of these condensed consolidated financial statements. Consolidated statements of changes in equity (unaudited) FINANCIAL STATEMENTS Galapagos Q3 Report 2022 29
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 2021. 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. 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 2021. New standards and interpretations applicable for the annual period beginning on 1 January 2022 did not have any material 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. Business combinations are accounted for using the acquisition method. In the statement of financial position, the acquiree’s identifiable assets, liabilities and contingent liabilities are initially recognized at their fair value at the acquisition date. The results of acquired operations are included in our consolidated income statement from the date on which control is obtained. Any contingent consideration to be transferred by us will be recognized at fair value at the acquisition date. Subsequent changes to the fair value of the contingent consideration, which is deemed to be an asset or liability, will be recognized in profit or loss. The excess of the fair value of the total purchase consideration transferred over the fair value of the acquired assets and assumed liabilities is recognized as goodwill. The valuations in support of fair value determinations are based on information available at the acquisition date. Acquisition related costs are expensed as incurred. Notes to the unaudited condensed consolidated interim financial statements for the first nine months of 2022 Basis of preparation Impact of COVID-19 on the financial statements Significant accounting policies New accounting policies as a result of recent transactions Business combinations FINANCIAL STATEMENTS Galapagos Q3 Report 2022 30
We determine and allocate the purchase price relating to the acquisition of CellPoint to the assets acquired and liabilities assumed as of the acquisition date, being 21 June 2022. The purchase price determination process requires us to use significant estimates and assumptions that determine the present fair value of the contingent consideration included in the transaction. These estimates depend on development, regulatory and sales-based milestones that are adjusted by our best estimate of their probability of success and discounted. We also anticipate to use significant estimates and assumptions in the finalization of the purchase price accounting process. Key sources of estimation uncertainty Acquisition of CellPoint FINANCIAL STATEMENTS Galapagos Q3 Report 2022 31
We reported net sales of Jyseleca for the first nine months of 2022 amounting to €60.5 million (€6.1 million in the first nine months of 2021). Related costs of sales in the first nine months of 2022 amounted to €7.9 million. The following table summarizes our collaboration revenues for the nine months ended 30 September 2022 and 2021: Third quarter of Nine months ended 30 September (thousands of €) Over time Point in time 2022 2021 2022 2021 Recognition of nonrefundable upfront payments and license fees 101,325 58,928 305,626 291,370 Gilead collaboration agreement for filgotinib 43,633 1,277 133,018 118,021 Gilead collaboration agreement for drug discovery platform 57,692 57,651 172,608 173,348 Milestone payments 7,821 (978) 35,759 18,391 Gilead collaboration agreement for filgotinib 7,821 (978) 33,759 18,391 Sobi distribution agreement for Jyseleca — 2,000 - Royalties 1,923 553 8,285 1,950 Gilead royalties on Jyseleca 1,923 557 8,240 1,907 Other royalties—(4) 44 43 Total collaboration revenues 111,068 58,503 349,669 311,711 Details of the unaudited condensed consolidated interim results Product net sales Collaboration revenues FINANCIAL STATEMENTS Galapagos Q3 Report 2022 32
The rollforward of the outstanding balance of the current and non-current deferred income between 1 January 2022 and 30 September 2022 can be summarized as follows: (thousands of €) Total Gilead collaboration agreement for filgotinib Gilead collaboration agreement for drug discovery platform (1) Other deferred income On 1 January 2022 2,364,701 604,875 1,759,828—Milestones achieved 18,238 18,238 Significant financing component (2) 5,673 5,673 Revenue recognition of upfront (305,626) (133,018) (172,608) Revenue recognition of milestones (33,759) (33,759) Other movements 3,457 3,457 On 30 September 2022 2,052,686 462,009 1,587,220 3,457 (1) The upfront received and the outstanding balance at 1 January 2022 and at 30 September 2022 comprise the issuance liabilities for the warrants 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. FINANCIAL STATEMENTS Galapagos Q3 Report 2022 33
The following table summarizes our research and development expenditure for the nine months ended 30 September 2022 and 2021: Third quarter of Nine months ended 30 September (thousands of €) 2022 2021 2022 2021 Personnel costs (44,044) (40,102) (130,001) (134,256) Subcontracting (54,412) (49,907) (158,472) (189,100) Disposables and lab fees and premises costs (5,286) (5,401) (15,596) (17,688) Depreciation and impairment (3,091) (5,998) (35,646) (14,097) Professional fees (3,317) (3,747) (10,719) (10,788) Other operating expenses (4,399) (4,040) (13,633) (12,092) Total research and development expenditure (114,549) (109,196) (364,067) (378,022) The increase in depreciation and impairment for the first nine months of 2022 is primarily due to an impairment of €26.7 million of previously capitalized upfront fees related to our collaboration with Molecure on the dual chitinase inhibitor OATD-01. The table below summarizes our R&D expenditure for the nine months ended 30 September 2022 and 2021, broken down by program. Third quarter of Nine months ended 30 September (thousands of €) 2022 2021 2022 2021 Filgotinib program (62,255) (40,656) (178,402) (128,496) SIKi program (9,692) (19,625) (35,789) (71,860) TYK2 program on GLPG3667 (5,931) (5,482) (15,009) (19,456) Ziritaxestat program (114) (4,001) (752) (23,420) Other programs (36,557) (39,432) (134,115) (134,790) Total research and development expenditure (114,549) (109,196) (364,067) (378,022) Operating costs and other operating income Operating costs Research and development expenditure FINANCIAL STATEMENTS Galapagos Q3 Report 2022 34
The following table summarizes our sales and marketing expenses for the nine months ended 30 September 2022 and 2021: Third quarter of Nine months ended 30 September (thousands of €) 2022 2021 2022 2021 Personnel costs (17,726) (16,403) (53,449) (43,274) Depreciation (660) (153) (1,782) (321) External outsourcing costs (12,226) (15,190) (37,897) (40,149) Sales and marketing expenses recharged to Gilead - 15,680 31 41,207 Professional fees (744) (143) (2,278) (323) Other operating expenses (2,949) (1,445) (9,938) (3,755) Total sales and marketing expenses (34,305) (17,655) (105,313) (46,616) The termination of our 50/50 filgotinib co-commercialization cost sharing agreement with Gilead explains a significant part of the increase in sales & marketing expenses. The following table summarizes our general and administrative expenses for the nine months ended 30 September 2022 and 2021: Third quarter of Nine months ended 30 September (thousands of €) 2022 2021 2022 2021 Personnel costs (18,875) (14,851) (54,504) (52,419) Depreciation and impairment (2,129) (1,901) (6,426) (14,631) Legal and professional fees (5,935) (4,161) (16,752) (17,629) Other operating expenses (7,434) (6,881) (19,692) (19,972) Total general and administrative expenses (34,372) (27,793) (97,373) (104,651) Sales and marketing expenses General and administrative expenses FINANCIAL STATEMENTS Galapagos Q3 Report 2022 35
The following table summarizes our other operating income for the nine months ended 30 September 2022 and 2021: Third quarter of Nine months ended 30 September (thousands of €) 2022 2021 2022 2021 Grant income 486 1,878 1,495 5,665 R&D incentives 7,216 10,152 23,119 29,653 Other 4,135 752 4,860 1,027 Total other operating income 11,837 12,781 29,474 36,345 Other operating income FINANCIAL STATEMENTS Galapagos Q3 Report 2022 36
The following table summarizes our financial income/expenses (–) for the nine months ended 30 September 2022 and 2021: Third quarter of Nine months ended 30 September (thousands of €) 2022 2021 2022 2021 Fair value adjustments and net currency exchange differences Net currency exchange gain 44,647 21,149 104,815 54,762 Fair value re-measurement of warrants 129 198 80 3,025 Fair value loss on financial assets held at fair value through profit or loss (2,913) Fair value gain/loss (-) on current financial investments 14,195 (1,373) 26,005 (7,206) Total fair value adjustments and net currency exchange differences 58,971 19,974 130,900 47,669 Other financial income: Interest income 5,622 714 9,240 2,156 Discounting effect of non-current R&D incentives receivables 23 23 69 69 Other finance income 15 10 366 90 Total other financial income 5,660 747 9,675 2,315 Other financial expenses: Interest expenses (1,721) (4,049) (5,927) (8,474) Discounting effect of non-current deferred income (1,874) (2,400) (5,673) (7,170) Discounting effect of other non-current liabilities (812) - (812) - Other finance charges (398) (529) (662) (681) Total other financial expenses (4,806) (6,978) (13,074) (16,325) Total net financial result 59,825 13,743 127,501 33,659 Financial income/expenses FINANCIAL STATEMENTS Galapagos Q3 Report 2022 37
Galapagos FINANCIAL STATEMENTS Cash position Cash and cash equivalents and current financial investments totaled €4,362.1 million on 30 September 2022 (€4,703.2 million on 31 December 2021). Cash and cash equivalents and current financial investments comprised cash at banks, term deposits, treasury bills and money market funds. 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 €235.3 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 current accounts. Our credit risk is mitigated by selecting a panel of highly rated financial institutions for our deposits. Current financial investments comprised €1,625.7 million of term deposits which all had an original maturity longer than three months and which are not available on demand within three months. Our current financial investments also comprised money market funds and treasury bills. Our portfolio of treasury bills contains only AAA rated paper, issued by Germany. 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. (thousands of €) 30 September 31 December 2022 2021 Money market funds 1,310,203 1,317,460 Treasury bills 750,696 877,349 Term deposits 1,625,657 275,000 Total current financial investments 3,686,557 2,469,809 Cash at banks 440,261 1,225,860 Term deposits 235,259 1,007,508 Total cash and cash equivalents 675,519 2,233,368 Total current financial investments and cash and cash equivalents 4,362,076 4,703,177 On 30 September 2022, our cash and cash equivalents and current financial investments included $951.6 million held in U.S. dollars ($942.5 million on 31 December 2021) 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 38 Galapagos Q3 Report 2022
FINANCIAL STATEMENTS € exchange 97.1 million. loss (–)/gain in case of a 10% change in the EUR/U.S. dollar exchange rate amounts to Capital increase shares On 30 September were issued, 2022, fully Galapagos paid up and NV’s of the share same capital class. was The represented below table by summarizes 65,835,511our shares. capital All increases for the period ended 30 September 2022. (thousands of €, except share data) Number of shares Share capitalShare premiumShare capital and share premiumAverage exercise price sub- scription rights (in €/sub- scription right)Closing share price on date of capital increase (in €/share) On 1 January 202265,552,721292,0752,730,3913,022,467 18 March 2022: exercise of subscription rights95,5005171,6432,16022.6157.38 20 June 2022: exercise of subscription rights80,2904341,0251,46018.1853.52 27 September 2022: exercise of subscription rights107,0005792,4973,07628.7544.49 On 30 September 202265,835,511293,6052,735,5573,029,162 39 Galapagos Q3 Report 2022
FINANCIAL STATEMENTS Note to the cash flow statement Nine months ended 30 September (thousands of €) 20222021 Adjustment for non-cash transactions Depreciation and impairment43,85429,050 Share-based compensation expenses51,08562,971 Increase in retirement benefit obligations and provisions405285 Unrealized exchange gains and non-cash other financial result(102,163)(47,975) Discounting effect of non-current deferred income5,6737,170 Discounting effect of other non-current liabilities812- Fair value re-measurement of warrants(80)(3,025) Net change in (fair) value of current financial investments(26,004)7,206 Fair value adjustment financial assets held at fair value through profit or loss-2,913 Other non-cash expenses712455 Total adjustment for non-cash transactions(25,707)59,050 Adjustment for items to disclose separately under operating cash flow Interest expense5,9278,474 Interest income(7,557)(2,146) Tax expense3,229(316) Total adjustment for items to disclose separately under operating cash flow1,5996,013 40 Galapagos Q3 Report 2022
FINANCIAL STATEMENTS Nine months ended 30 September (thousands of €) 20222021 Adjustment for items to disclose under investing and financing cash flows Gain on sale of subsidiaries-(22,191) Gain (-)/loss on sale of fixed assets(17)1 Realized exchange gain on sale of current financial investments-(6,645) Interest income on current financial assets(1,683)(10) Total adjustment for items to disclose separately under investing and financing cash flow(1,700)(28,845) Change in working capital other than deferred income Increase in inventories(5,667)(2,060) Decrease in receivables63,50282,008 Decrease in liabilities(363)(33,306) Total change in working capital other than deferred income57,47246,642 Business combinations of On Cell Point 21 June 2022 for a total we acquired, agreed payment in an all-cash at completion transaction, of € 100% 125 million, of the shares including and consideration voting interests for consideration other liabilities up associated to €100.0 with million the transaction is due when amounting certain development to €10.3 million. (€20.0 Additional million),contingent regulatory acquisition (€30.0 million) date and of these sales-based milestones (€50.0 amounted million) milestones to €22.9 million. Would This be achieved. fair value Total is measured fair value with at timing most significant and the inputs discount being rate. the During probability the third of success quarter of of reaching 2022 no these changes milestones, were expected made to recognized the assumptions in financial used results. in the valuation. The discounting impact, amounting to €0.8 million, is price On the of same $14 million, date we including acquired consideration all of the outstanding for other liabilities capital associated of Abound Bio, with for the a transaction. total agreed The market main and reason to for significantly these acquisitions broaden is our to position portfolio ourselves and capabilities. in next-generation As a result cancer of therapy these of-care acquisitions, cell therapy we gain supply access model to an as innovative, well as a scalable, next-generation decentralized fully human and automated antibody-based point-therapeutics have the potential platform. to disrupt Combined the CAR-T and supported treatment by paradigm. us as a The fully goal integrated is to expand biopharma, the current they 41 Galapagos Q3 Report 2022
FINANCIAL STATEMENTS market improved for treatment CAR-T therapies options. and have an important impact on patients in need of additional and Details transactions, of the the preliminary preliminary fair purchase value consideration of identifiable and assets provisional and liabilities good will acquired at the acquisition in both date are as follows: 21 June 2022 (thousands of €)CellPointAboundBioTotal Property, plant and equipment1,289965 Other non-current assets814 Trade and other receivables162- Cash and cash equivalents3,1794,279 Other current assets1,254536 Trade and other liabilities(32,789)(587) Current deferred income-(474) Net assets acquired(26,824)4,723 Consideration paid in cash107,75014,976 Fair value re-measurement of previously held equity investment-342 Deferred consideration6,088- Fair value of contingent consideration22,865- Fair value of total consideration136,70315,318 Goodwill163,52610,595 Exchange differences on goodwill-872 Goodwill in the balance sheet163,52611,467174,994 42 Galapagos Q3 Report 2022
FINANCIAL STATEMENTS Net cash outflow arising on acquisition (thousands of €)CellPointAboundBioTotal Consideration paid in cash107,75014,976 Less: cash and cash equivalents balances acquired(3,179)(4,279) Cash out from acquisition of subsidiaries, net of cash acquired104,57110,698115,270 Cash used in operating activities for other liabilities related to the acquisition of subsidiaries11,08011,080 The consolidated preliminary interim fair value financial of the identifiable statements assets as per and30 liabilities September are included 2022. To in our date condensed we have adjustments performed a to preliminary the trade fair and value other analysis liabilities. Of We the expect business the combinations, provisional amount with corresponding of goodwill to change valuation significantly of the different upon assets the completion and liabilities ofa cquired, the purchase including price the allocation, valuation resulting of in-process from R&D. the Contingencies and commitments Contractual obligations and commitments collaboration We have certain partners. purchase commitments principally with CRO subcontractors and certain become On 30 September due as follows: 2022, we had outstanding obligations for purchase commitments, which Less thanMore than (thousands of €)Total1 year1—3 years3—5 years5 years Purchase commitments439,317269,994137,12732,041155 collaboration In addition to agreement the table above, with Gilead we have for filgotinib. a contractual The cost contractual sharing cost obligation sharing related commitment to our commitments amounted to of €276.1 €230.7 million million at at 30 30 September September 2022 2022 reflected for which in the we table have above. direct purchase Contingent liabilities and assets We refer to our Annual Report 2021 for a description of our contingent liabilities and assets. 43 Galapagos Q3 Report 2022
FINANCIAL STATEMENTS Related party transactions rights On 6 May under 2022, Subscription certain members Right Plan of2022 the Executive BE. The final Committee number were of accepted offered subscription new subscription rights under 2 September Subscription 2022. The Right subscription Plan 2022 rights BE was have enacted an exercise by notary term deed of eight on years 7 Julyas 2022 of the and date on of Galapagos the offer. share The exercise on Euronext price Amsterdam of the subscription and Brussels rights on is € the 57.46 day(i. preceding e. the closing the price date of of the the offer) the beneficiaries . Each subscription under Subscription right gives the Right right Plan to subscribe 2022 BE, the for one subscription new Galapagos rights vest share. only For and all made. fully on The the subscription first day of the rights fourth are calendar not transferable year following and can thein calendar principle year not in be which exercised the grant prior was to 1 January 2026. Executive The table below Committee sets forth under the Subscription number of Right subscription Plan 2022 rights (B) and accepted Subscription by each Right member Plan of 2022 the BE, respectively, during the first nine months of 2022: Number of 2022 subscription NameTitlerights accepted Stoffels IMC BV (1)CEO1,000,000 Bart FiliusPresident, COO & CFO68,000 Walid Abi-SaabCMO32,000 Michele MantoCCO24,000 (1) Scoffels IMC BU (permanently presented by Dr. Pul Stoffels). During half-year the 2022 first financial nine months report, of there 2022,were other no than changes as disclosed to related in the party paragraph transactions above disclosed or in our in the the first 2021 nine annual months report of 2022. that potentially had a material impact on the financials of Galapagos of Events after the end of the reporting period In impact this Q3 cannot report be 2022, reliably we estimated announced at this our time new and strategic will be direction included for in which future the reporting actual periods. financial Approval of interim financial statements The interim financial statements were approved by the Board of Directors on 31 October 2022. 44 Galapagos Q3 Report 2022
OTHER INFORMATION Glossary 100 points clinical response Percentage patients of patients achieving a 100-point decrease in CDAI score during a clinical trial in CD ACR American College of Rheumatology ACR20 (ACR 20/50/70) in American the number College of of swollen Rheumatology and tender 20% joints response as well rate as a signifies 20% or a greater 20% or improvement greater improvement in three out response of five rates, other respectively disease-activity measures. ACR50 and ACR70 reflect the same, for 50% and 70% ADPKD enlarged Autosomal with dominant fluid-filled polycystic cysts, leading kidney to disease, kidney failure. a disease Other where organs typically may be both affected kidneys as become well ADS American GLPG and Depositary CUSIP number Share; 36315X101. Galapagos One has ADS a Level is equivalent 3 ADS listed to one on ordinary Nasdaq share with ticker in Galapagos symbol NV AFM Dutch Authority for the Financial Markets Anemia the Condition body’s in tissues which the patient has an inadequate number of red blood cells to carry oxygen to Anti-TNF Tumor necrosis factor. An anti-TNF drug acts by modulation of TNF Antibody A combine blood chemically protein produced with substances in response which to the and body counteracting recognizes as a alien, specific such antigen. as bacteria, Antibodies viruses, and foreign substances 45 Galapagos Q3 Report 2022
Assays Laboratory tests to determine characteristics Attrition rate development The historical paths. success Statistically rate for drug seen, discovery investment and in development, at least 12 target-based based on publicly programs known is programs required to are ensure discontinued that at least before one reaching of these Phase will reach 3 because a Phase they3 are study. not successful Most new enough drug R&D to be approved BID dosing Twice-daily dosing (bis in die) Bioavailability Assessment (oral) administration of the amount of product candidate that reaches a body’s systemic circulation after Biomarker Substance product candidate used as has an a indicator biological of effect a biological process, particularly to determine whether a Bispecific antibody An antibody that binds to two different antigens Black & Scholes model widely A mathematical used in the description pricing of European of financial options markets and and subscription derivative rights investment instruments that is Bridging trial extrapolate Clinical trial performed data from one to “bridge” population or extrapolate to another one for the dataset same to drug that candidate, for another or situation, to move I .from e. to IV to subcutaneous dosing CAR-T Chimeric engineered antigen to produce receptor an T artificial cells (also T cell known receptor as CAR for T use cells) in immunotherapy are T cells that have been genetically CD19 CD19 hallmark is a of protein B-cells, found the protein on the has surface been of used B-cells, to diagnose a type of cancers white blood that arise cell.from Since this CD19 type is of a cell—notably B-cell lymphomas 46 Galapagos Q3 Report 2022
CDAI Crohn’s pre-defined Disease weight Activity as a way Index, to evaluating quantify the patients impact on of CD eight different factors, each of which has a CDAI remission In <150 the FITZROY trial, the percentage of patients with CD who showed a reduction of CDAI score to CFTR Cystic channel fibrosis in vertebrates transmembrane that is encoded conductance by the regulator CFTR gene. (CFTR) It is is hypothesized a membrane that protein inhibition and chloride of the CFTR a CFTR channel inhibitor might reduce cyst growth and enlargement for patients with ADPKD. GLPG2737 is CHIT1/AMCase Chitotriosidase chitinase. CHIT1(CHIT1) is predominantly is a protein involved coding gene, in macrophage and AM Case activation. is an inactive Inhibition acidic of mamalian chitinase preclinical activity translates models.into GLPG4716 a potential is a therapeutic CHIT1/AMCase benefit inhibitor in lung targeting diseases a key like pathway IPF, as shown in tissue in remodeling CHMP Committee committee responsible for Medicinal for Products human for medicines Human Use and is plays the European a vital role Medicines in the authorization Agency’s (EMA) of medicines in the European Union (EU) CIR up Crédit to 30% d’Impôrt of the Recherche, annual investment or research incredit. French Under R&D operations, the CIR, theover French a period government of three refunds years. Galapagos benefits from the CIR through its operations in Romainville, just outside Paris CRP C-reactive inflammation protein is a protein found in the blood, the levels of which rise in response to Cash position Current financial investments and cash and cash equivalents Chitinase chitinase Chitinaseactivity is an enzyme translates thatinto degrades a potential chitin, therapeutic involved in benefit the human in lung innate diseases immunity. IPF, Inhibition as shown of in preclinical models 47 Galapagos Q3 Report 2022
OTHER INFORMATION Chronic Lymphocytic Leukemia (CLL) starts Chronic in lymphocytic cells that become leukemia certain is the white most blood common cells (called leukemia lymphocytes) in adults. It inis the a type bone of marrow. cancer that The cancer (leukemia) cells originate in the bone marrow and migrate to the bloodstream Clinical Proof of Concept (PoC) Point therapeutic in the setting drug development process where the product candidate first shows efficacy in a Complete Response Letter (CRL) application A letter send is by notthe ready FDA for to approval indicate that in itsthe present review form cycle for an application is complete and the Compound A chemical substance, often a small molecule with drug-like properties Contract research organization (CRO) biotechnology Organization which and medical provides devices drug discovery industry on and a contract development basis services to the pharmaceutical, Corticosteroids Any have of various a group metabolic of steroid functions hormones and produced some arein used the to adrenal treat inflammation cortex or made synthetically. They Crohn’s disease (CD) ultimately An IBD involving in some inflammation cases surgical of removal the small of and parts large of the intestines, bowel leading to pain, bleeding, and Cytokine A category of small proteins which play important roles in signaling in processes in the body DARWIN Phase daily administration, 2 program for for filgotinib up to 24 in weeks RA. DARWIN in RA patients 1 explored with insufficient three doses, response in twice-daily to methotrexate and once-(MTX) three and once-daily who remained doses for on their up to stable 24 weeks background in RA treatment patients with with MTX. insufficient DARWIN response 2 explored to methotrexate double-blind, placebo-controlled (MTX) and who washed trials out which of recruited their treatment approximately with MTX. 900 DARWIN patients 1 globally and 2 were and for patients which are results on 200 were mg filgotinib, reported except in 2015. for DARWIN U.S. males 3 is who a long are on term 100 extension mg. The week trial in 156 which results all from DARWIN 3 were reported in 2019 48
OTHER INFORMATION DAS28 (CRP) counts DAS28 is of an 28RA defined Disease joints, Activity the Score physician’s based global on a calculation health assessment that uses and tender a serum and swollen marker joint for calculation: inflammation, scores such range as C- from reactive 2.0 to protein. 10.0, with DAS28 scores (CRP) below includes 2.6 being the considered C-reactive remission protein score DDI study effects Drug-drug of interaction a drug caused study. by concomitant This type of administration study will assess with if there another is a change drug in the action or side DIVERGENCE Phase small bowel 2 programs CD and with DIVERGENCE filgotinib in 2 Crohn’s in fistulizing disease. CD DIVERGENCE 1 was an exploratory study in DIVERSITY Phase 3 program evaluating filgotinib in CD DMARDs Disease the symptoms modifying anti rheumatic drugs; these drugs address the disease itself rather than just Deep venous thrombosis (DVT) The lower formation limbs. The of blood one or clots more can blood travel clots to the in one lung of and the cause body’s a large pulmonary veins, most embolism commonly in the Degradation The molecules process by which proteins are lost through the use of drugs such as PROTACs or small Dermatomyositis rash, Dermatomyositis and inflammatory is a rare myopathy, inflammatory or inflamed disease. muscles, Common causing symptoms muscle weakness include distinctive skin Development All development activities required research, to chemical bring a new and drug pharmaceutical to the market. development This includes and preclinical regulatory and filings clinical of product candidates Discovery Process department by which that oversees new medicines target are and discovered drug discovery and/or research designed. through At Galapagos, to nomination this is the of preclinical candidates 49 Galapagos Q3 Report 2022
OTHER INFORMATION Disease-modifying Addresses disease the disease itself, modifying the disease progression, not just the symptoms of the Dose-range finding study Phase treatment 2 clinical in patients. study exploring Results are the used balance to determine between doses efficacy for and later safety studies among various doses of Double-blind patient Term to is characterize taking placebo a clinical or the trial treatment in which being neither evaluated the physician nor the patient knows if the EC European Commission EMA European Medicines Agency, in charge of European market authorization of new medications Efficacy Effectiveness for intended use End-to-end functional A process solution, that takes usually a system without or strong service reliance from on beginning third parties to end and delivers a complete Endoscopy A non-surgical procedure involving use of an endoscope to examine a person’s digestive tract FDA The promoting U.S. Food public and health Drug and Administration in charge of is American the American market agency approval responsible of new medications for protecting and FIH First-in-human safety, tolerability clinical and pharmacokinetics trial, usually conducted of the product in healthy candidate volunteers with the aim to assess the FILOSOPHY Phase 4 program evaluating filgotinib in RA FINCH Phase 3 program evaluating filgotinib in RA 50 Galapagos Q3 Report 2022
OTHER INFORMATION FITZROY A weeks. double-blind, Full results placebo were published controlled in Phase The Lancet 2 trial in with 2016 filgotinib in 177 CD patients for up to 20 FORM 20-F Form 20-F is an SEC filing submitted to the US Securities and Exchange Commission FSMA The Financiële Belgian Diensten market en authority: Markten Financial Services and Markets Authority, or Autoriteit voor FTE FTE Full-time of 1.0equivalent; means that a the way equivalent to measure work an of employee’s one full-time involvement worker was in a used project. on the For project example, an Fast Track of A designation drugs which by treat the a FDA serious of an or investigational life-threatening drug condition for expedited and fill review an unmet to facilitate medical development need Fee-for-service service Payment performed system where the service provider is paid a specific amount for each procedure or Filgotinib Formerly inhibitor, known approved as GLPG0634, in RA and UC commercial in European nameUnion, is Jyseleca. GreatSmall Britain, molecule and Japan. preferential Filgotinib JAK1 is partnered with Gilead. Filgotinib currently is in Phase 3 trials in CD, and in a Phase 4 trial in RA Fistulizing CD Fistulae region. Fistulae are inflammatory are one of tracts the that most most severe often sequelae occur between of luminal the distal CD and colon the and lifetime the perianal risk of occurrence is close to 50% of those with active CD Futility analysis Analysis information of the to be likelihood gathered. of The a trial term to ‘futility’ meet its isprimary used to refer endpoint, to the based low likelihood on a subset of aof clinical the total trial to that achieve it is unlikely its objectives. to achieve In statistical particular, significance stopping a can clinical save trial resources when that the interim could be results used on suggest more promising research G&A expenses General & administrative expenses 51 Galapagos Q3 Report 2022
OTHER INFORMATION GLIDER Phase 2 Proof of Concept trial with SIK2/3 inhibitor GLPG3970 in Sjögren’s syndrome GLPG0555 A JAK1 inhibitor in Phase 1b. Development was stopped in July 2022 GLPG0634 Molecule number currently known as filgotinib and Jyseleca GLPG2737 AbbVie A compound but Galapagos currently retained in Phase rights 2 in ADPKD. Outside This of CF compound is part of the CF collaboration with GLPG3121 was A compound stopped in in July Phase 2022 1 targeting JAK1/TYK2 directed toward inflammation (IBD). Development GLPG3667 A in TYK2 July 2021 kinase inhibitor discovered by us, topline results from the Phase 1b in psoriasis reported GLPG3970 in A SIK2/3 UC, psoriasis inhibitor and in multiple RA were Phase reported 2 Proof in July of 2021. Concept The studies. compound Topline was results discontinued from the in studies March 2022 GLPG4399 A SIK3 inhibitor currently in Phase 1 directed toward inflammation GLPG4586 inlicensed A compound from with Fibrocor. undisclosed The development mode of action was in stopped preclinical in July phase 2022 directed toward fibrosis and GLPG4605 A SIK2/3 inhibitor in the preclinical phase, currently directed toward fibrosis GLPG4716 molecule A chitinase have inhibitor been returned in licensed to Molecure from Molecure in July 2022 (previously OncoArendi). The rights to the 52 Galapagos Q3 Report 2022
OTHER INFORMATION Genome grow An organism’s and develop complete set of genetic information needed to build that organism and allow it to HDL High-density contributes tolipoprotein. heart disease HDL at high scavenges levels. High and levels reduces of HDL low-density reduce the lipoprotein risk for heart (LDL) disease, which while low levels of HDL increase the risk of heart disease Hemoglobin A body protein and carries inside red carbon blood dioxide cells that back carries to the oxygen lungs from the lungs to tissues and organs in the Histology Study of the microscopic structures of tissues Histopathology Microscopic examination of tissues for manifestations of a disease IBD Inflammatory bowel, including Bowel CD and Disease. UC. CD This affects is a general the small term and for large an intestine, autoimmune while disease UC affects affecting the large the ultimately, intestine. Both in some diseases cases, involve surgical inflammation removal of part of the of intestinal the bowel wall, leading to pain, bleeding, and IPF progressive Idiopathic pulmonary decline in lung fibrosis. function. A chronic Pulmonary and fibrosis ultimately involves fatal scarring disease of characterized lung tissue and by is a the “idiopathic” cause of is shortness used because of breath. the cause Fibrosis of pulmonary is usually associated fibrosis is still with unknown a poor prognosis. The term 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 In-/out-licensing patent, Receiving/granting or other proprietary permission right, from/to in exchange another for company a fee and/or or institution royalty to use a brand name, 53 Galapagos Q3 Report 2022
OTHER INFORMATION Inflammatory diseases A large, unrelated group of disorders associated with abnormalities in inflammation Intellectual property Creations patents, trademarks of the mind or that copyrights have commercial value and are protected or protectable, including by Intersegment Occurring between the different operations of a company Investigational New Drug (IND) Application United an experimental States Federal druglaw across requires state a lines, pharmaceutical usually to company clinical investigators, to obtain an before exemption a marketing to ship this application exemption, for the allowing drug has them been to perform approved. clinical The IND studies is the means by which the sponsor obtains JAK Janus cytokines kinases and growth (JAK) are factors, criticalincluding components thoseof that signaling are elevated mechanisms in RA. Filgotinib utilized by is a a preferential number of JAK1 inhibitor Jyseleca® Jyseleca® is the brand name for filgotinib LDL Low-density lipoprotein. LDL contributes to heart disease at high levels Lipoprotein bloodstream. Lipoproteins are There substances are two main made types of of protein cholesterol: and fat High-density that carrylipoprotein cholesterol (HDL), through or “good” your cholesterol and Low-density lipoprotein (LDL), or “bad” cholesterol Liver enzymes Inflamed liver enzymes, or injured into the liver bloodstream cells secrete higher than normal amounts of certain chemicals, including Lymphocyte Type of white blood cell that is part of the immune system MACE Major research adverse cardiovascular events; a composite endpoint frequently used in cardiovascular 54 Galapagos Q3 Report 2022
OTHER INFORMATION MANGROVE Phase 2 program with GLPG2737 in autosomal dominant polycystic kidney disease 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 authorization Ministry of new of medications Health, Labor and Welfare (MHLW), in charge of Japanese market MHRA Medicines and Healthcare products Regulatory Agency in Great Britain MTX Methotrexate; a first-line therapy for inflammatory diseases Mayo Score Mayo from Score four categories, is a Disease including Activity Score stool for frequency, ulcerative rectal colitis. It bleeding, is a composite findings of of subscores flexible proctosigmoidoscopy ranging from 0–12 or colonoscopy, and physician’s global assessment, with a total score Milestone Major payment achievement in a project or program; in our alliances, this is usually associated with a Modulation molecules, The process peptides, by which antibodies the function or of cell proteins therapyis changed through the use of drugs such as small Molecule collections with Chemical specific libraries, target usually classes .consisting These collections of drug-like can be small screened molecules against that a are target designed to generate to interact initial “hits” in a drug discovery program NDA New Drug Application 55 Galapagos Q3 Report 2022
OTHER INFORMATION NICE The national National guidance Institute and for advice Health to improve and Care health Excellence; and social an independent care in the UK public body that provides NK cells Natural viruses killer cells, type of white blood cell with granules of enzymes which can attack tumors or Neutrophil in Type the of body. immune Neutrophils system cell are which another is one type of of the white first blood cell types cell to which travel fight to the infection site of by an ingesting infection and killing microorganisms Non-Hodgkin Lymphoma (NHL) of Non-Hodgkin the body’s germ-fighting lymphoma is immune a type of system. cancer In that non-Hodgkin begins in the lymphoma, lymphatic white system, blood which cells is called part lymphocytes grow abnormally and form tumors throughout the body Oligonucleotide protein Short DNA expression or RNA molecule that can be used as research tools or therapeutic drug to change Oral dosing Administration of medicine by the mouth, either as a solution or solid (capsule, pill) form Osteoarthritis (OA) The breakdown most common of cartilage form in the of joints arthritis, leading usually to pain, occurring stiffness, after and middle swelling age, marked by chronic Outsourcing Contracting work to a third party PASI Psoriasis the severity Area (erythema, and Severity induration Index; an and index desquamation) used to express and percentage the severity of of affected psoriasis. area It combines PRAC for Pharmacovigilance assessing all aspects Risk Assessment of risk management Committee of human of the European medicines Medicines Agency, responsible 56 Galapagos Q3 Report 2022
OTHER INFORMATION PROTAC Proteolysis that play a role targeting in disease chimera, processes a special small molecule capable of removing unwanted proteins Pharmacokinetics (PK) absorption, Study of what distribution a body does to the to at issues, drug; the metabolism fate of a substance and excretion. delivered These to processes a body. This determine includes the blood concentration of the drug and its metabolite(s) as a function of time from dosing Phase 1 tolerability, First stage pharmacokinetics of clinical testing of of a an drug, investigational usually performed drug designed in a small number to assess of the healthy safety human and volunteers Phase 2 Second order to stage determine of clinical efficacy, testing, tolerability usually and performed the dose in to no use more than several hundred patients, in Phase 3 Large definitive clinical understanding trials, usually of conducted the efficacy in and several tolerability hundred of the to several candidate thousand treatment; patients serves to as gain the a principal basis for regulatory approval and access to the market Phenotypic screening Phenotypic to alter a cell’s screening disease is characteristics. a strategy used Animal in drug models discovery and cell-based to identify assays molecules are both with the strategies ability used screening to identify does not these rely on molecules. knowing In the contrast identity of to the target-based specific drug drug target discovery, or its hypothetical phenotypic role capture in the complex disease. biological A key benefit mechanisms this approach that are has not over otherwise target-based achievable screening, is its capacity to Pivotal trials Registrational clinical trials Placebo biologically A substance active having preparation no pharmacological effect but administered as a control in testing a Point-of-care Drug treatment is provided close to or near the patient 57 Galapagos Q3 Report 2022
OTHER INFORMATION Preclinical humans. Stage of Consists drug research of in vitro development, and in vivo undertaken screening, prior pharmacokinetics, to the administration toxicology, of and the chemical drug to upscaling Preclinical candidate (PCC) A development new molecule process and potential drug that meets chemical and biological criteria to begin the Product candidate for Substance development, that has starting satisfied with the formal requirements preclinical of safety early preclinical evaluation testing followed and by has clinical been testing selected for the treatment of a certain disorder in humans Proof of Concept (POC) A Concept clinical trial trial is inusually which first with evidence a small number for efficacy of patients of a candidate and for drug short is duration gathered. to A get Proof a first of impression of drug activity Proof of Concept study mechanism Phase 2 patient of action study in which activity as well as safety in patients is evaluated, usually for a new 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 product candidates and development for internal operations; pipeline or unit as part responsible of risk/reward for discovery sharing alliances and developing with partners new Refractory “Refractory” to, treatment refers to a patient with cancer that is/has become resistant to, or does not respond Relapsed “Relapsed” improvement refers to a patient with cancer that develops cancer again after a period of 58 Galapagos Q3 Report 2022
OTHER INFORMATION Replication The of cell process division by which DNA is copied to produce two identical DNA molecules during the process Rheumatoid arthritis (RA) A cartilage chronic, destruction, systemic inflammatory bone erosion disease and disability that causes joint inflammation, and usually leads to S&M expenses Sales and marketing expenses SEC Securities and Exchange Commission in the US SELECTION Phase 2021 3 program evaluating filgotinib in UC patients. Full results were published in The Lancet in SES-CD scores Simple values from endoscopic 0 (unaffected) score for to 3 CD, (highly involving affected) review of five pre-defined bowel segments, assigning SIK Salt-inducible kinase Screening in Method a biochemical usually applied assay against at the a beginning series of of small a drug molecules discovery or antibodies campaign, to where obtain a target an initial is tested set of “hits” that show activity against the target. These hits are then further tested or optimized Short interfering RNA A research tool that is used to silence the activity of specific genes Sjögrens syndrome Sjögren’s often resulting Syndrome in chronic is a systemic dryness of inflammatory the eyes and disease mouth which can be felt throughout the body, Small bowel CD (SBCD) CD gastrointestinal causes chronic tract inflammation including the and stomach erosion and of small the intestines. and large intestines. It can affect While different isolated regions SBCD of is the an uncommon ileum, is common presentation of CD, involvement of some portion of the small bowel, particularly 59 Galapagos Q3 Report 2022
OTHER INFORMATION Statin are Statins at high are a risk class of of cardiovascular lipid-lowering disease. medications They that are reduce the most illness common and mortality cholesterol-lowering in those who drugs. atherosclerosis Low-density and lipoprotein coronary heart (LDL) disease carriers via of the cholesterol mechanisms play described a key role by in the the development lipid hypothesis of Systemic lupus erythematosus even An autoimmune kidney failure disease, with systemic manifestations including skin rash, erosion of joints or TEAE treatments Treatment Emergent or any event Adverse already Event, present is any that event worsens not inpresent either intensity prior to or the frequency initiation following of the exposure to the treatments TYK residues Tyrosine of kinase specific is an proteins enzyme inside that a can cell. transfer It functions a phosphate as an “on” group or “off” from switch ATP in to many the tyrosine cellular also functions. attach Tyrosine phosphates kinases to belong other amino to a larger acids class such of as enzymes serine known and threonine. as protein GLPG3667 kinases which is a reversible and selective TYK2 kinase domain inhibitor Target therapeutic Proteïn that intervention has been shown or discovery to play of a role a medicine in a disease process and that forms the basis of a Target discovery Identification and validation of proteins that have been shown to play a role in a disease process Technology access fee License collections) payment made in return for access to specific technology (e.g. compound or virus 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 60 Galapagos Q3 Report 2022
OTHER INFORMATION Ulcerative colitis (UC) UC inflammation is an IBD causing throughout chronic the inflammation gastrointestinal of tract) the lining of the colon and rectum (unlike CD with Venous thrombotic events a When venous a thromboembolism blood clot breaks (VTE). The loose abbreviation and travels DVT/PE in refers the to blood, a VTE this where is a called deep vein thrombosis (DVT) has moved to the lungs (PE or pulmonary embolism) 61 Galapagos Q3 Report 2022
OTHER INFORMATION Financial calendar 23 February 2023 Full year 2022 results 23 March 2023 Annual report 2022 25 April 2023 Annual Shareholders’ meeting 4 May 2023 First quarter 2023 results 3 August 2023 Half year 2023 results 2 November 2023 Third quarter 2023 results 62 Galapagos Q3 Report 2022
OTHER INFORMATION Colophon Concept, nexxar GmbH, design Vienna and online – Online programming annual reports and online sustainability reports www.nexxar.com Frank Photography van Delft Copy deadline: 3 November 2022 report This report or at is www. also available glpg.com in Dutch and available for download in the Downloads section of this 63 Galapagos Q3 Report 2022
OTHER INFORMATION Contact Sofie Van Gijsel Sandra Cauwenberghs Head of Investor Relations Director of Investor Relations Galapagos NV Galapagos NV Generaal De Wittelaan L11 A3 Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium 2800 Mechelen, Belgium Tel. +1 781 296 1143 Tel. +32 15 34 29 00 Email: ir@glpg.com Email: ir@glpg.com Marieke Vermeersch Head of Corporate Communication Galapagos NV Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium Tel. +32 479 49 06 03 Email: media@glpg.com 64 Galapagos Q3 Report 2022