On February 24, 2023 Galapagos NV (Euronext & NASDAQ: GLPG) reported 2022 results, supported by strong adoption of Jyseleca across Europe, and provides outlook for 2023 (Press release, Galapagos, FEB 24, 2023, View Source [SID1234627678]).
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Commenting on the full year results 2022, Dr. Paul Stoffels, CEO and Chairman of the Board of Directors of Galapagos said: "As I reflect on my first year as the new CEO and Chairman, we can be proud of what we have achieved in a very short time to reset our organization and embrace a new R&D strategy for a sustainable future. 2022 was a year of transformation and change.
Adding oncology as a new strategic therapeutic area, and CAR-T and biologicals as novel drug modalities, were key steps in our transformation. Through the acquisitions of CellPoint and AboundBio, we gained access to a breakthrough, point-of-care CAR-T manufacturing platform, a clinical-stage CAR-T oncology pipeline and a research engine for novel, differentiated CAR-T constructs, that together have the potential to deliver life-saving medicines to more patients, faster and more efficiently.
In addition, we remain fully committed to immunology, an area where there is still significant unmet patient need and for which we have built deep scientific know-how and expertise since our founding. With our programs targeting multiple modes-of-action and drug modalities, most recently including CAR-T, we have a differentiated portfolio of preclinical through to commercial assets."
Bart Filius, President, COO and CFO of Galapagos, added: "We are very proud that our first marketed medicine, Jyseleca, an orally administered JAK1 preferential inhibitor, continued to deliver solid in-market performance with a growing European base and €87.6 million in net sales for the year 2022, reaching 18,000 patients with RA and UC across Europe. Based on the topline results from the Phase 3 DIVERSITY study of filgotinib in Crohn’s disease, Galapagos decided not to submit a Marketing Authorization Application in Europe in this indication. On the other hand, following the positive opinion from the Committee for Medicinal Products for Human Use on the Type II variation application based on the safety data on semen parameters from the MANTA and MANTA-RAy studies, the European label for RA and UC has been updated, potentially broadening access for European patients who may benefit from this treatment. For 2023, we anticipate net Jyseleca sales in a range between €140 and €160 million. For the longer term, we believe Jyseleca can reach €400 million peak sales in RA, UC and axial spondyloarthritis.
Financially, we ended 2022 with a strong balance sheet of €4.1 billion in cash and current financial investments, which provides us with the necessary means to look for additional external innovation to accelerate our R&D portfolio while progressing our internal programs. As part of our company transformation, we have meaningfully reduced our cost base. We anticipate our full year 2023 operating cash burn to decline to a range of €380 to €420 million."
2022 operational review and post-period events
Jyseleca commercial & regulatory progress
Adoption across Europe with reimbursement for RA in 15 countries and for UC in 11 countries
Sobi, our distribution and commercialization partner in Eastern and Central Europe, Portugal, Greece, and the Baltic countries, launched Jyseleca in RA in the Czech Republic and Portugal, resulting in €2.0 million milestone payments to Galapagos
The Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain and the Ministry of Health, Labour and Welfare (MHLW) in Japan approved filgotinib 200mg for the treatment of moderate to severe UC
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use, CHMP, adopted the recommendation of the PRAC to add measures to minimize risk of serious side effects with JAK inhibitors used for chronic inflammatory disorders
Positive opinion issued by the CHMP for Jyseleca’s European label update based on testicular function safety data from MANTA/RAy semen parameter studies
Pipeline update
Started preparations to initiate a Phase 2 program with TYK2 inhibitor GLPG3667 in dermatomyositis (DM) and systemic lupus erythematosus (SLE)
Discontinued our activities in fibrosis and kidney disease as a result of our new strategic therapy area focus
Phase 2 study with GLPG2737 in polycystic kidney disease is ongoing with topline results expected in the first half of 2023. If successful, we aim to outlicense the program
Halted development of SIK3 inhibitor GLPG4399; medicinal chemistry activities to identify SIK inhibitors with improved pharmacology continues
Reported initial encouraging safety and efficacy data at ASH (Free ASH Whitepaper)1 2022 from the ongoing ATALANTA-1 Phase 1/2 study in refractory/relapsed NHL with CD19 CAR-T candidate, GLPG5101, manufactured at point-of-care
Corporate update
Appointed Dr. Paul Stoffels as Chief Executive Officer, succeeding Onno Van de Stolpe, as of 1 April 2022. Following approval by Galapagos’ shareholders on 26 April 2022, adopted a 1-tier governance model and Dr. Paul Stoffels was appointed Chairman of the Board of Directors
Implemented new strategic direction to accelerate innovation and time-to-patients, focused on key therapeutic areas of immunology and oncology, diversifying beyond small molecules to include CAR-T and biologicals, and set up of a fit-for-purpose R&D organization
Entered the field of oncology through the acquisitions of CellPoint and AboundBio in all-cash transactions against payment of an upfront amount of €125 million for CellPoint, with an additional €100 million to be paid upon achievement of certain milestones, and against payment of $14 million for AboundBio
Received various transparency notifications from EcoR1 Capital LLC and FMR LLC, indicating that their shareholding in Galapagos increased, crossing the 5% threshold, to 5.2% and 5.9% respectively, of our current outstanding shares
Raised €6.7 million through the exercise of subscription rights
Announced changes to the Executive Committee: Dr. Walid Abi-Saab (Chief Medical Officer) and Dr. André Hoekema (Chief Business Officer) retired from the company, and Valeria Cnossen (General Counsel) and Annelies Missotten (Chief Human Resources Officer) were appointed as new members of the Executive Committee as of 1 January 2023
Post-period events
Poster presentation at the annual EBMT-EHA2 congress demonstrating initial encouraging safety and efficacy results from the ongoing EUPLAGIA-1 Phase 1/2 study with point-of-care manufactured CD19 CAR-T candidate, GLPG5201, in patients with refractory/replapsed CLL and small lymphocytic lymphoma (rrSLL), with or without Richter’s transformation (RT). All 7 out of 7 eligible rrCLL patients, including 4 patients with RT, responded to treatment (Objective Response Rate of 100%), and GLPG5201 showed an acceptable safety profile with no cytokine release syndrome (CRS) higher than grade 2, and no immune effector cell-associated neurotoxicity syndrome (ICAN) observed
Announced topline results from the DIVERSITY study, a combined induction and maintenance Phase 3 study of filgotinib in Crohn’s disease. While the co-primary endpoints for filgotinib 200mg in the maintenance part of the study were met and the observed safety profile is consistent with its known safety profile, the two induction cohorts missed the co-primary endpoints of clinical remission and endoscopic response at Week 10. Galapagos decided not to submit a Marketing Authorization Application in Europe based on these topline data
Financial performance
Key figures 2022 (consolidated)
(€ millions, except basic & diluted loss per share)
31 December 2022 group total 31 December 2021 group total
Product net sales 87.6 14.8
Collaboration revenues 417.7 470.1
Total net revenues 505.3 484.8
Cost of sales (12.1) (1.6)
R&D expenditure (515.1) (491.7)
G&Aiii and S&Miv expenses (292.5) (210.9)
Other operating income 46.8 53.7
Operating loss (267.5) (165.6)
Fair value adjustments and net exchange differences 51.5 61.3
Net other financial result 0.9 (18.7)
Income taxes (2.8) (2.4)
Net loss from continuing operations (218.0) (125.4)
Net profit from discontinued operations 22.2
Net loss of the period (218.0) (103.2)
Basic and diluted loss per share (€) (3.32) (1.58)
Current financial investments and cash and cash equivalents 4,094.1 4,703.2
Details of the financial results
Our net revenues in 2022 amounted to €505.3 million compared to €484.8 million in 2021.
We reported product net sales of Jyseleca in Europe in 2022 amounting to €87.6 million, compared to €14.8 million last year.
Cost of sales related to Jyseleca net sales in 2022 amounted to €12.1 million, compared to €1.6 million in 2021.
Collaboration revenues amounted to €417.7 million in 2022, compared to €470.1 million last year. The revenue recognition linked to the upfront consideration and milestone payments in the scope of the collaboration with Gilead for filgotinib, amounted to €174.4 million in 2022 (compared to €235.7 million in 2021). This decrease was due to a lower increase in the percentage of completion, slightly offset by higher revenue recognition of milestone payments, strongly influenced by the milestone achieved in 2022 related to the regulatory approval in Japan for UC.
On 8 February 2023 we announced topline results from the Phase 3 DIVERSITY trial of filgotinib in Crohn’s disease and, based on these topline data, decided not to submit a Marketing Authorization Application in Europe. While this recent event will not have an impact on our financial statements for the year ended 31 December 2022, we will provide further information in our 2022 annual report on the potential revenue recognition impact on our financial statements for the year ended 31 December 2023.
The revenue recognition related to the exclusive access rights granted to Gilead for our drug discovery platform amounted to €230.4 million in 2022 (compared to €230.6 million in 2021). We also recognized royalty income from Gilead for Jyseleca for €10.7 million in 2022 (compared to €3.8 million in 2021). Additionally, we recorded in 2022 milestone payments of €2.0 million triggered by the inital sales of Jyseleca in Czech Republic and Portugal by our distribution and commercialization partner Sobi.
Our deferred income balance at 31 December 2022 includes €1.5 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 development of filgotinib which is recognized over time until the end of filgotinib’s development period.
Our R&D expenditure in 2022 amounted to €515.1 million, compared to €491.7 million in 2021. Depreciation and impairment costs in 2022 amounted to €54.5 million (compared to €17.5 million in 2021). 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) and impairments of intangible assets related to other discontinued projects recorded in 2022. Personnel costs increased from €165.2 million in 2021 to €190.1 million in 2022 primarily related to increases in restructuring costs and accelerated non-cash cost recognition for subscription right plans related to good leavers. This was partly offset by a decrease in subcontracting costs from €251.1 million in 2021 to €214.9 million in 2022 following the evolution of our programs.
Our G&A and S&M expenses amounted to €292.5 million in 2022, compared to €210.9 million in 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 which explains €59.7 million of the variance. The cost increase was also explained by an increase in personnel costs of €26.6 million in 2022 compared to 2021, which are related to an increase in our commercial work force driven by the commercial launch of filgotinib in Europe, accelerated non-cash cost recognition for subscription right plans related to good leavers and restructuring costs.
Other operating income (€46.8 million in 2022 compared to €53.7 million in 2021) decreased, mainly driven by lower grant and R&D incentives income.
We reported an operating loss amounting to €267.5 million in 2022, compared to an operating loss of €165.6 million in 2021.
Net financial income in 2022 amounted to €52.4 million, compared to €42.6 million in 2021. Net financial income in 2022 was primarily attributable to €41.3 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 €6.9 million of positive changes in the (fair) value of our current financial investments. The other financial expenses also had the effect of discounting our non-current deferred income of €7.7 million. Net interest income amounted to €11.1 million in 2022 compared to €8.8 million of net interest expense in 2021.
We reported a group net loss in 2022 of €218.0 million, compared to a group net loss of €103.2 million in 2021.
Cash position
Current financial investments and cash and cash equivalents totaled €4,094.1 million on 31 December 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 €609.1 million in 2022, compared to a net decrease of €466.1 million in 2021. This net decrease was composed of (i) €513.8 million of operational cash burn, offset by (ii) €6.9 million positive changes in (fair) value of current financial investments and €44.5 million of mainly positive exchange rate differences, (iii) €6.7 million of cash proceeds from capital and share premium increase from exercise of subscription rights in 2022, and (iv) €153.4 million cash out from the acquisitions of CellPoint and AboundBio, net of cash acquired.
Acquisition of CellPoint and AboundBio
We have completed the initial accounting of the acquisitions of Cellpoint and AboundBio, including the purchase price allocations. Disclosures on the business combinations will be included in our full year 2022 annual report.
Outlook 2023
Immunology franchise
This year, we expect additional reimbursement decisions for Jyseleca in UC in Europe, and we 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 the final decision from the European Commission following CHMP’s adoption of the recommendation of the PRAC to harmonize the EU labels of all approved JAK inhibitors. We plan to start a Phase 3 study in axial spondyloarthritis, and anticipate announcing the initial results from the FILOSOPHY Real-World Evidence Phase 4 study in RA.
We aim to recruit the first patients in the Phase 2 programs with our TYK2 inhibitor product candidate, GLPG3667, in DM in the first quarter of 2023, followed by the start of a study in SLE later this year.
To accelerate time-to-patients, we are diversifying our drug modality capabilities in immunology and recently announced that we aim to start clinical development with the CD19 CAR-T candidate, GLPG5101, in refractory systemic lupus erythematosus (rSLE).
Oncology portfolio
Patient recruitment in the European sites of the ATALANTA-1 Phase 1/2 study with CD19 CAR-T candidate, GLPG5101, in rrNHL as well as in the EUPLAGIA-1 study with CD19 CAR-T candidate GLPG5201 in rrCLL/SLL is progressing. We aim to provide Phase 1 topline results from both studies around mid-2023 and aim to include US patients in 2023.
We aim to expand the CAR-T portfolio with a BCMA CAR-T product candidate, GLPG5301, in refractory/relapsed multiple myeloma (rrMM) and aim to start enrolling patients in the PAPILIO-1 Phase 1/2 study in Europe in the second quarter of 2023.
Financial guidance
For the full year 2023, we anticipate further reduction of our cash burn and anticipate landing between €380 and €420 million (compared to €514 million for the full year 2022), including the acceleration in oncology. We also anticipate between €140 and €160 million net sales of Jyseleca for the full year 2023.
Taking into account multiple factors, we have revised our estimates of the peak sales potential for Jyseleca in RA, UC and axial spondyloarthritis and expect this to reach €400 million by the end of the decade.
Annual report 2022
We are currently finalizing the financial statements for the year ended 31 December 2022. Our independent auditor has confirmed that its audit procedures are substantially completed and have not revealed any material corrections required to be made to the financial information included in this press release. Should any material changes arise during the audit’s finalization, an additional press release will be issued. We aim to publish the fully audited annual report for the full year 2022 on, or around, 23 March 2023.
Conference call and webcast presentation
We will host a conference call and webcast presentation tomorrow 24 February 2023, at 14:00 CET / 8 AM ET. 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.
The live webcast is available on glpg.com or via the following link. The archived webcast will be available for replay shortly after the close of the call on the investor section of the website.
Financial calendar
Date Details
23 March 2023 Publication Annual Report 2022 and 20-F 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)
22 February 2024 Full year 2023 results (webcast 23 February 2024)