abrooklyn
10月前
Galapagos showcases innovative approach in hematological cancer care with clinical and translational data presentations at EBMT congress 2024
Source: GlobeNewswire Inc.
Two oral presentations and one poster on encore preliminary data from Phase 1/2 CD19 CAR-T studies in non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) / Richter transformation (RT)
Mechelen, Belgium; 4 April 2024, 22:01 CET – Galapagos NV (Euronext & NASDAQ: GLPG) today announced that four abstracts, including two oral presentations on encore preliminary clinical and translational data for its seven-day vein-to-vein CAR-T product candidates GLPG5101 and GLPG5201, will be presented at the 50th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) to be held in Glasgow, UK, on 14-17 April 2024.
ATALANTA-1 and EUPLAGIA-1 are ongoing Phase 1/2 open-label, multi-center studies designed to assess the safety, efficacy and feasibility of point-of-care manufactured GLPG5101 and GLPG5201 in patients with relapsed/refractory NHL, and relapsed/refractory CLL and RT, respectively. The primary objective of the Phase 1 part of the studies is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study. The primary objective of the Phase 2 part of the studies is to assess the Objective Response Rate (ORR) and the secondary objectives include the analysis of the Complete Response (CR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and feasibility of point-of-care manufacturing. GLPG5101 and GLPG5201 are second generation anti-CD19/4-1BB CAR-T product candidates, administered as a single fixed intravenous dose.
“We are committed to accelerating breakthrough innovations to extend the reach of CAR-T therapies to patients with rapidly progressing cancers,” said Dr. Jeevan Shetty, M.D., Head of Clinical Development Oncology at Galapagos. “We believe that the preliminary safety and efficacy data from our ongoing Phase 1/2 studies with our CD19 CAR-T therapy candidates in patients with relapsed/refractory NHL, CLL and RT, combined with our unique, innovative decentralized manufacturing approach that enables a seven-day vein-to-vein time, support the promise of GLPG5101 and GLPG5201 in addressing the critical needs of patients facing poor prognosis.”
The following table provides a summary of Galapagos’ presentations at EBMT 2024:
Abstract Title Authors/Presenter Presentation date/time
Galapagos encore abstracts
Seven-Day Vein-to-Vein Point-of-Care Manufactured CD19 CAR T-Cell Therapy (GLPG5101) in Relapsed/Refractory Non-Hodgkin Lymphoma (NHL): Results from the Phase 1 ATALANTA-1 Trial Marie José Kersten, Kirsten Saevels, Sophie Servais, Yves Beguin, Joost S.P. Vermaat, Eva Santermans, Stavros Milatos, Maike Spoon, Marte C. Liefaard, Claire Vennin, Margot J. Pont, Anna D.D. van Muyden, Maria T. Kuipers, Sébastien Anguille Oral presentation number: OS16-04
Date: 17 April, 12:57-13:06 (session runs 12:30-13:45)
Session: Oral Session 16: CAR-T outcomes in ALL
Seven-Day Vein-to-Vein Point-of-Care–Manufactured CD19 CAR T-Cell Therapy (GLPG5201) in Relapsed/Refractory Chronic Lymphocytic Leukemia Including Richter Transformation: Results from the Phase 1 EUPLAGIA-1 Study
Valentin Ortiz-Maldonado, Nuria Martinez-Cibrian, Julio Delgado, Sergi Betriu, Leticia Alserawan, Ana Triguero, Nadia Verbruggen, Maike Spoon, Marte C. Liefaard, Anna D.D. van Muyden, Natalia Tovar Oral presentation number: OS16-05
Date: 17 April, 13:06-13:15 (session runs 12:30-13:45)
Session: Oral Session 16: CAR-T outcomes in ALL
EUPLAGIA-1: Seven-Day Vein-to-Vein Point-of-Care Manufactured GLPG5201 Anti-CD19 CAR-T Cells Display Early Phenotypes in Relapsed/Refractory CLL, including RT Esmée P. Hoefsmit, Sandra Blum, Claire Vennin, Kirsten Van Hoorde, Sergi Betriu,
Leticia Alserawan, Julio Delgado, Nadia Verbruggen, Anna D.D. van Muyden, Henriëtte Rozema, Ruiz Astigarraga, Margot J. Pont Poster number: A073
Date: 15 April, 18:00-19:00
Session: Printed poster: CAR-based Cellular Therapy - Clinical
PAPILIO-1: Phase 1/2, Multicenter, Open-Label Study to Evaluate Feasibility, Safety and Efficacy of Point-of-Care–Manufactured Anti-BCMA CAR T-Cell Therapy (GLPG5301) in Relapsed/Refractory Multiple Myeloma Niels W.C.J. van de Donk, Sébastien Anguille, Jo Caers, Marte C. Liefaard, Christian Jacques, Anna D.D. van Muyden Poster number: P049
Date: 14 April, 08:30-18:00
Session: ePoster: CAR-based Cellular Therapy - Clinical
About Galapagos’ decentralized CAR-T manufacturing platform
Galapagos’ decentralized, innovative CAR T-cell manufacturing platform near the point-of-care offers the potential for the administration of fresh, fit cells with a vein-to-vein time of seven days, greater physician control and a significantly improved patient experience. The platform consists of an end-to-end xCellit® workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon®) and a proprietary quality control testing and release strategy.
About the ATALANTA-1 study (EudraCT 2021-003272-13)
ATALANTA-1 is an ongoing Phase 1/2, open-label, multicenter study to evaluate the safety, efficacy and feasibility of point-of-care manufactured GLPG5101, a CD19 CAR-T product candidate, in patients with relapsed/refractory non-Hodgkin lymphoma (rrNHL). GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The primary objective of the Phase 1 part of the study is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment of efficacy and feasibility of near the point-of-care manufacturing of GLPG5101. The dose levels that were evaluated in Phase 1 are 50x106 (DL1) and 110x106 (DL2) and 250x106 (DL3) CAR+ viable T cells. The primary objective of the Phase 2 part of the study is to evaluate the Objective Response Rate (ORR), while the secondary objectives include Complete Response (CR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of point-of-care manufacturing. Each enrolled patient will be followed for 24 months.
About the EUPLAGIA-1 study (EudraCT 2021-003815-25)
EUPLAGIA-1 is an ongoing Phase 1/2 open-label, multi-center study evaluating the safety, efficacy and feasibility of point-of-care manufactured GLPG5201, a CD19 CAR-T product candidate, in patients with relapsed/refractory chronic lymphocytic leukemia (rrCLL) and small cell lymphocytic lymphoma (rrSLL), with or without Richter transformation (RT). GLPG5201 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. Patients with CD19+ rrCLL or rrSLL with ≥2 lines of prior therapy are eligible to participate, and patients with RT are eligible regardless of prior therapy. The primary objective of the Phase 1 part of the study is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study. The dose levels that were evaluated in the Phase 1 part of the study are 35x106 (DL1) and 100x106 (DL2) CAR+ viable T cells. The primary objective of the Phase 2 part of the study is to assess the Objective Response Rate (ORR) and the secondary objectives include the analysis of the Complete Response (CR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and feasibility of point-of-care manufacturing.
About Galapagos
We are a biotechnology company with operations in Europe and the US dedicated to developing transformational medicines for more years of life and quality of life. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders. For additional information, please visit www.glpg.com or follow us on?LinkedIn?or?X (formerly Twitter).
Contact
Media inquiries:
Marieke Vermeersch
+32 479 490 603
media@glpg.com
Jennifer Wilson
+ 44 7539 359 676
media@glgp.com Investor inquiries:
Sofie Van Gijsel
+1 781 296 1143
ir@glpg.com
Sandra Cauwenberghs
+32 495 58 46 63
ir@glpg.com
Forward-looking statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements are often, but are not always, made through the use of words or phrases such as “anticipate,” “expect,” “plan,” “estimate,” “will,” “continue,” “aim,” “intend,” “future,” “potential,” “could,” “indicate,” “forward,” as well as similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements regarding preliminary, interim and topline data from the EUPLAGIA-1 and ATALANTA-1 studies and other analyses related to Galapagos’ CD19 CAR-T program, statements related to Galapagos’ plans, expectations and strategy with respect to the EUPLAGIA-1 and ATALANTA-1 studies, and statements regarding the expected timing, design and readouts of the EUPLAGIA-1 and ATALANTA-1 studies, including the expected recruitment for such trials. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause Galapagos’ actual results to be materially different from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include, without limitation, the risk that preliminary or interim clinical results may not be replicated in ongoing or subsequent clinical trials; the risk that ongoing and future clinical studies with GLPG5201 and GLPG5101 may not be completed in the currently envisaged timelines or at all, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of GLPG5201 and GLPG5101 due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties (including its collaboration partner Lonza) and that Galapagos’ estimations regarding its GLPG5201 and GLPG5101 development programs and regarding the commercial potential of GLPG5201 and GLPG5101 may be incorrect, as well as those risks and uncertainties identified in Galapagos’ Annual Report on Form 20-F for the year ended 31 December 2022 filed with the U.S. Securities and Exchange Commission (SEC) and its subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.
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abrooklyn
11月前
Galapagos announces full year 2023 results and outlook for 2024
Source: GlobeNewswire Inc.
Full year 2023 key financials:
Group net revenues of €783.5 million, including Jyseleca® net sales of €112.3 million
Cash and current financial investments of €3.7 billion on 31 December 2023
Operational cash burni of €414.8 million, within guidance
2023 and year-to-date key updates:
Transferred Jyseleca® business, including approximately 400 positions, to Alfasigma S.p.A.
Achieved encouraging data from ongoing Phase 1/2 studies with CD19 CAR-T product candidates, GLPG5101 in rrNHL and GLPG5201, in rrCLL, with or without RT
Expanded CAR-T pipeline with start of Phase 1/2 study with BCMA CAR-T product candidate GLPG5301 in rrMM
Enrolled first patients in Phase 2 study with TYK2 inhibitor, GLPG3667, in DM and SLE
For strategic reasons, it was decided not to continue development of CD19 CAR-T candidate in rSLE
Expanded point-of-care CAR-T network in the U.S. with manufacturing agreements with Landmark Bio and Thermo Fisher Scientific
Signed strategic research and license collaboration with BridGene Biosciences in precision oncology
Participated in Series C financing round of US-based precision oncology company, Frontier Medicines
Appointed Thad Huston as CFO and COO, and Dr. Susanne Schaffert and Mr. Simon Sturge as Non-Executive Independent Directors
Webcast presentation tomorrow, 23 February 2024, at 14:00 CET / 8:00 am ET, www.glpg.com
Mechelen, Belgium; 22 February 2024, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) reports full year 2023 results and provides outlook for 2024.
“In 2023, we took significant steps to reposition our organization, renew our focus on value creation, and advance our efforts to bring transformational medicines to patients around the world,” said Dr. Paul Stoffels1, CEO and Chairman of the Board of Directors of Galapagos. “Following the successful transfer of the Jyseleca® business last month, we are moving forward with a streamlined portfolio and enhanced focus on our differentiated and innovative pipeline. We are determined to generate sustainable, long-term value for our shareholders, our patients, and our employees.”
Dr. Stoffels continued, “We recently presented promising new data from our ongoing CD19 CAR-T programs and started the Phase 1/2 multiple myeloma BCMA CAR-T study, marking another milestone in the build-up of our oncology CAR-T portfolio. In addition, we entered into a strategic collaboration with BridGene Biosciences to advance our growing early-stage pipeline in precision oncology. As we look to the year ahead, we strive to make important progress in advancing our clinical programs, while further expanding our early-stage pipeline of small molecule programs.”
Thad Huston, CFO and COO of Galapagos, concluded, “We ended 2023 with a strong financial position of €3.7 billion in cash and current financial investments. We will continue to execute on business development opportunities and invest in our pipeline to drive value for all our stakeholders.”
Corporate and Operational Performance 2023
Oncology portfolio
GLPG5201 (CD19 CAR-T) in relapsed/refractory chronic lymphocytic leukemia (rrCLL) and Richter transformation (RT) (cut-off date: 6 September 2023)
Patient recruitment of the Phase 1 dose-finding part of EUPLAGIA-1 has been completed: 15 patients were enrolled (6 at dose level 1 (DL1); and 9 at dose level 2 (DL2)), all of whom were diagnosed with rrCLL and 9 with additional RT.
Presented encouraging preliminary Phase 1 data at the ASH Annual Meeting, which demonstrated clinically meaningful results in severely compromised patient populations and highlighted the potential of Galapagos’ point-of-care CAR-T manufacturing platform to deliver a fresh product with a median vein-to-vein time of only seven days.
GLPG5101 (CD19 CAR-T) in relapsed/refractory non-Hodgkin lymphoma (rrNHL) (cut-off date: 1 September 2023)
To further build a robust data package, patient recruitment of the Phase 1 dose-finding part of ATALANTA-1 is ongoing: 14 rrNHL patients with diffuse large B cell lymphoma, mantle cell lymphoma and indolent lymphoma were enrolled (7 at DL1 and 7 at DL2). In parallel, enrollment of the Phase 2 expansion study is ongoing, and the first 9 patients have been dosed.
Presented encouraging preliminary Phase 1 and Phase 2 data at the ASH Annual Meeting, which demonstrated clinically meaningful results in severely compromised patient populations and highlighted the potential of Galapagos’ point-of-care CAR-T manufacturing platform to deliver a fresh product with a median vein-to-vein time of only seven days.
GLPG5301 (BCMA CAR-T) in relapsed/refractory multiple myeloma (rrMM)
First patients dosed in the PAPILIO-1 Phase 1/2 study to evaluate the safety, efficacy and feasibility of point-of-care manufactured GLPG5301 in patients with rrMM after ≥2 prior lines therapy.
Continued to evolve our oncology research activities in biologics, cell therapies and small molecules to deliver best-in-class medicines for patients with high unmet medical need.
Immunology portfolio
Jyseleca® (filgotinib) (JAK1): successfully transferred to Alfasigma S.p.A.
Achieved reimbursement for both RA and UC across Western Europe. Sobi, the distribution and commercialization partner for filgotinib in Eastern and Central Europe, Portugal, Greece, and the Baltic countries, launched Jyseleca® in Poland and Slovenia in both RA and UC, and in Croatia and Greece for RA.
The European Commission endorsed the recommendation of the Pharmaceutical Risk Assessment Committee (PRAC) to add safety measures for the JAK inhibitors class of medicines.
Based on topline results from the Phase 3 DIVERSITY study in Crohn’s disease, a Marketing Authorization Application (MAA) was not submitted in Europe in this indication and the MAA for filgotinib in UC in Switzerland did not proceed.
First patients dosed in the pivotal Phase 3 OLINGUITO study in axial spondyloarthritis (AxSpA).
Pipeline programs
First patients dosed in the Phase 2 GALARISSO study of novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor, GLPG3667, in dermatomyositis (DM) and the Phase 2 GALACELA study in systemic lupus erythematosus (SLE).
We initiated multiple small molecules programs to further build our immunology research pipeline.
Corporate update
Thad Huston was appointed as Chief Financial Officer (CFO) and Chief Operating Officer (COO), succeeding Bart Filius, as of 1 July 2023.
The Board of Directors appointed Dr. Susanne Schaffert and Mr. Simon Sturge as Non-Executive Independent Directors by way of cooptation, replacing respectively Dr. Rajesh Parekh and Dr. Mary Kerr, who stepped down.
The Board of Directors granted 1,538,400 subscriptions rights under new subscription right plans, after acceptance by the beneficiaries.
Successfully completed the integrated drug discovery collaboration transaction with NovAliX.
Signed letter of intent with Alfasigma to transfer the entire Jyseleca® business to Alfasigma, including the European and UK Marketing Authorizations, as well as the commercial, medical and development activities for Jyseleca® and approximately 400 Galapagos positions in 14 European countries.
Galapagos and Gilead amended the Filgotinib Agreement to terminate the existing 50/50 global development cost sharing arrangement with Galapagos bearing the costs going forward, and to terminate Galapagos’ obligation to pay tiered royalties to Gilead on net sales of Jyseleca® in Europe, in addition to other amendments.
Signed an agreement with Boston-based Landmark Bio and started the technology transfer for the decentralized production of Galapagos’ CAR-T cell therapy candidates.
Hosted a Key Opinion Leader event highlighting Galapagos’ decentralized manufacturing platform and the data observed in the ongoing CD19 CAR-T Phase 1/2 studies.
Post-period events
For strategic reasons, it was decided not to continue development of our CD19 CAR-T candidate in refractory systemic lupus erythematosus (rSLE).
Participated in Series C financing round of Frontier Medicines, a pioneer in precision oncology with a unique technology platform and a pipeline of potential best-in-class assets that fit with Galapagos’ precision oncology R&D approach. The investment aligns with our innovation acceleration strategy to bring transformational medicines to patients around the world.
Poster presentation at the annual EBMT-EHA congress highlighting new preliminary translational data from EUPLAGIA-1, which demonstrate that Galapagos’ point-of-care manufacturing platform has the potential to enable a single infusion of fresh early-phenotype CD19 CAR-T cells with robust expansion and persistence in patients with rrCLL and in patients with RT.
Signed a share and asset purchase agreement with Alfasigma to transfer the entire Jyseleca® business to Alfasigma. As part of the transaction, the distribution agreement with Sobi and the amended Filgotinib Agreement between Galapagos and Gilead have been assigned to Alfasigma. The transaction was successfully completed on 31 January 2024. Freed-up resources will be reinvested in R&D growth areas.
Michele Manto’s mandate as Chief Commercial Officer and member of the Executive Committee of Galapagos ended in December 2023; he will join Alfasigma to lead the Jyseleca® business.
Further streamlined our operations with a reduction of approximately 100 positions across the Galapagos organization to align with the Galapagos’ renewed focus on innovation.
Signed a strategic collaboration and license agreement with BridGene Biosciences to further strengthen Galapagos' growing early-stage oncology precision medicine pipeline.
Entered into a strategic collaboration agreement with Thermo Fisher Scientific for CAR-T manufacturing and kitting services for Galapagos’ point-of-care CAR-T product candidate in the San Francisco area.
Financial performance
Full year 2023 key figures (consolidated)
(€ millions, except basic & diluted income/loss (-) per share)
31 December 2023 31 December 2022 % Change
Collaboration revenues 239.7 241.2 -1%
Total net revenues 239.7 241.2
R&D expenditure (241.3) (269.8) -11%
G&Aii and S&Miii expenses (134.0) (138.6) -3%
Other operating income 47.3 36.1 +31%
Operating loss (88.3) (131.1) -33%
Fair value adjustments and net exchange differences 16.3 51.5 -68%
Net other financial result 77.6 8.7
Income taxes (9.6) (0.6)
Net loss from continuing operations (4.0) (71.4)
Net profit/loss (-) from discontinued operations 215.7 (146.6)
Net profit/loss (-) of the year 211.7 (218.0)
Basic and diluted income/loss (-) per share (€) 3.21 (3.32)
Current financial investments, cash & cash equivalents 3,684.5 (*) 4,094.1 (**)
(*) Starting from Q3 2023, our current financial investments and cash and cash equivalents include accrued interests (for a total of €20.0 million on 31 December 2023)
(**) Excluding €9.9 million of net accrued interest income
DETAILS OF THE FULL YEAR 2023 FINANCIAL RESULTS
As a consequence of the recent transfer of our entire Jyseleca® business to Alfasigma, the revenues and costs related to Jyseleca® for the full year 2023 are presented separately from the results of our continuing operations on the line ‘Net profit/loss (-) from discontinued operations’ in our consolidated income statement. The comparative year 2022 has been restated accordingly for the presentation of the results related to the Jyseleca® business.
Results from our continuing operations
Collaboration revenues amounted to €239.7 million in 2023, compared to €241.2 million last year. The revenue recognition related to the exclusive access rights granted to Gilead for our drug discovery platform amounted to €230.2 million in 2023 (compared to €230.4 million in 2022). We also recognized royalty income from Gilead for Jyseleca® for €9.5 million in 2023 (compared to €10.7 million in 2022). Our deferred income balance at 31 December 2023 includes €1.3 billion allocated to our drug discovery platform that is recognized linearly over the remaining period of our 10-year collaboration.
Total operating loss from our continuing operations amounted to €88.3 million in 2023, compared to an operating loss of €131.1 million in 2022.
R&D expenditure in 2023 amounted to €241.3 million, compared to €269.8 million in 2022. Depreciation and impairment costs in 2023 amounted to €22.3 million (compared to €51.5 million in 2022). This decrease was primarily due to an impairment of €26.7 million of previously capitalized upfront fees related to our collaboration with Molecure and impairments of intangible assets related to other discontinued projects recorded in 2022. Personnel costs decreased from €115.5 million in 2022 to €95.8 million in 2023 primarily related to lower accelerated non-cash cost recognition for subscription right plans related to good leavers. This was partly offset by an increase in costs related to the evolution of our CAR-T programs.
S&M and G&A expenses amounted to €134.0 million in 2023, compared to €138.6 million in 2022. The decrease in S&M and G&A expenses is explained by a decrease in personnel expenses and other operating expenses, partly offset by an impairment of €7.6 million on a construction project in Mechelen, Belgium.
Other operating income (€47.3 million in 2023 compared to €36.1 million in 2022) increased, mainly driven by higher grant and R&D incentives income.
Net financial income in 2023 amounted to €93.9 million, compared to €60.2 million in 2022.
Fair value adjustments and net currency exchange results amounted to €16.3 million in 2023, compared to fair value adjustments and net currency exchange gains in 2022 of €51.5 million (this decrease was due to the evolution of the USD) and were primarily attributable to €20.4 million of unrealized currency exchange losses on our cash and cash equivalents and current financial investments at amortized cost in U.S. dollars, and to €38.3 million of net fair value gains of our current financial investments.
Net other financial income in 2023 amounted to €77.6 million, compared to net other financial income of €8.7 million in 2022. Net interest income amounted to €77.5 million in 2023 compared to €11.2 million of net interest income in 2022, due to an increase in the interest rates.
We had €9.6 million of tax expenses in 2023 (compared to €0.6 million in 2022). This increase was primarily due to the re-assessment of net deferred tax liabilities and corporate income tax payables due to a one-off intercompany transaction.
We reported a net loss from our continuing operations in 2023 of €4.0 million, compared to a net loss of €71.4 million in 2022.
Results from discontinued operations
(€ millions)
31 December 2023 31 December 2022 % Change
Product net sales 112.3 87.6 +28%
Collaboration revenues 431.5 176.4 +145%
Total net revenues 543.8 264.0 +106%
Cost of sales (18.0) (12.1) +49%
R&D expenditure (190.2) (245.3) -22%
G&Aii and S&Miii expenses (131.3) (153.9) -15%
Other operating income 13.0 10.7 +21%
Operating profit/loss (-) 217.3 (136.5)
Net financial result 0.5 (7.8) -106%
Income taxes (2.1) (2.3) -9%
Net profit/loss (-) from discontinued operations 215.7 (146.6)
Net profit from discontinued operations related to Jyseleca® amounted to €215.7 million, compared to net loss amounting to €146.6 million for the year 2022.
We recorded product net sales of Jyseleca® in Europe of €112.3 million for 2023 within guidance, compared to €87.6 million in 2022. Cost of sales related to Jyseleca® net sales in 2023 were €18.0 million (€12.1 million for the year 2022).
Collaboration revenues for the development of filgotinib with Gilead amounted to €429.4 million in 2023, compared to €174.4 million for the year 2022. This increase was explained by a substantial decrease in our assessment of the remaining costs to complete the filgotinib development following the recent transfer of our entire Jyseleca® business to Alfasigma, including the transfer of the remaining development performance obligation after closing of the transaction. As a result, there is a substantial increase of the percentage of completion of our performance rights and obligation and a positive catch-up released to revenues.
Our deferred income balance at 31 December 2023 still includes €26.3 million allocated to the filgotinib development that will be recognized as collaboration revenue in 2024.
Total operating profit from discontinued operations amounted to €217.3 million in 2023, compared to an operating loss of €136.5 million in 2022.
R&D expenditure for the filgotinib development in 2023 amounted to €190.2 million, compared to €245.3 million in 2022. This decrease was mainly due to the discontinuation of the DIVERSITY clinical trials in CD. Personnel expenses decreased by €15.0 million, from €74.6 million in 2022 to €59.6 million in 2023, subcontracting costs decreased as well by €39.0 million, from €153.7 million in 2022 to €114.7 million in 2023.
S&M and G&A expenses related to the Jyseleca® business amounted to €131.3 million in 2023, compared to €153.9 million in 2022. Personnel expenses decreased by €6.4 million, from €78.7 million in 2022 to €72.3 million in 2023, while external outsourcing costs decreased by €17.0 million, from €52.8 million in 2022 to €35.8 million in 2023.
Other operating income (€13.0 million in 2023 compared to €10.7 million in 2022) increased, mainly driven by higher R&D incentives income.
Net financial income attributable to the Jyseleca® business in 2023 amounted to €0.5 million, compared to a net financial cost of €7.8 million in 2022. The decrease is primarily explained by a lower discounting effect of long-term deferred revenue for the development of filgotinib because we expect to recognize the remaining revenues in 2024.
We reported a net profit in 2023 of €211.7 million, compared to a net loss of €218.0 million in 2022.
Cash position
Current financial investments and cash and cash equivalents totaled €3,684.5 million on 31 December 2023, as compared to €4,094.1 million on 31 December 2022 (excluding €9.9 million of net accrued interest income).
Total net decrease in cash and cash equivalents and current financial investments amounted to €409.6 million in 2023, compared to a net decrease of €609.1 million in 2022. This net decrease was composed of (i) €414.8 million of operational cash burn, (ii) €20.4 million of negative exchange rate differences, (iii) €7.0 million cash-out related to the acquisition of CellPoint B.V., (iv) €14.0 million acquisition of financial assets held at fair value through profit or loss, partly offset by (v) €24.3 million positive changes in fair value of current financial investments, (vi) €1.8 million of cash proceeds from capital and share premium increase from exercise of subscription rights in 2023, and (vii) €12.9 million of accrued interest income on term deposits and €7.6 million of accrued interest income on treasury bills.
Outlook 2024
Financial outlook
For the full year 2024, we anticipate a further reduction in our cash burn and expect the cash burn to be between €280 million and €320 million (compared to €414.8 million for the full year 2023), not including future potential business development opportunities.
R&D Outlook
We aim to progress three CAR-T Phase 1/2 studies in hemato-oncology: GLPG5101 in rrNHL; GLPG5201 in rrCLL, with or without RT; and GLPG5301 in rrMM.
We expect to file IND applications in the U.S. to begin clinical development of our CAR-T programs in hemato-oncology.
We plan to further upscale our CAR-T network and operations in the U.S. and Europe, and potentially other key regions.
Business development
We will continue to evaluate multiple product candidates and business development opportunities to further leverage our internal capabilities and accelerate and expand our pipeline of potential best-in-class investigational medicines in our therapeutic focus areas of immunology and oncology.
Annual report 2023
We are currently finalizing the financial statements for the year ended 31 December 2023. Our independent auditor has confirmed that its audit procedures in relation to the financial information for the year ended 31 December 2023 in accordance with the International Standards on Auditing 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 full year 2023 annual report on, or around, 28 March 2024.
Conference call and webcast presentation
We will host a conference call and webcast presentation on 23 February 2024, at 14:00 CET / 8:00 am ET. To participate in the conference call, please register using this link. Dial-in numbers will be provided upon registration. The conference call can be accessed 10 minutes prior to the start of the call using the access information provided in the e-mail received upon registration or by using 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 2024
Date Details
28 March Publication Annual Report 2023 and 20-F 2023
30 April Annual Shareholders’ meeting
2 May First quarter 2024 results (webcast 3 May 2024)
1 August Half Year 2024 results (webcast 2 August 2024)
30 October Third quarter 2024 results (webcast 31 October 2024)
About Galapagos
We are a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders. For additional information, please visit www.glpg.com or follow us on LinkedIn or X (formerly Twitter).
Contact
Media inquiries:
Marieke Vermeersch
+32 479 490 603
media@glpg.com Investor inquiries:
Sofie Van Gijsel
+1 781 296 1143
ir@glpg.com
Sandra Cauwenberghs
+32 495 58 46 63
ir@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,” “continue,” “should,” “encouraging,” “aim,” “progress,” “remain,’ “explore,” “further” as well as similar expressions. These statements include, but are not limited to, the guidance from management regarding our financial results (including guidance regarding the expected operational use of cash for the fiscal year 2024), statements regarding our regulatory outlook, statements regarding the amount and timing of potential future milestones, and other payments , statements regarding our R&D plans, strategy and outlook, including progress on our oncology or immunology portfolio, and potential changes in such strategy, statements regarding our pipeline and complementary technology platforms facilitating future growth, statements regarding our commercialization efforts for filgotinib, our product candidates, and any of our future product candidates or approved products, if any, 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 our ongoing and planned preclinical studies and clinical trials, including but not limited to (i) filgotinib in RA, UC and AxSpA, (ii) GLPG3667 in SLE and DM, (iii) GLPG5101 in rrNHL and rSLE, (iv) GLPG5201 in rrCLL, with or without RT, and (v) GLPG5301 in rrMM, including recruitment for trials and topline results for trials and studies in our portfolio, statements relating to interactions with regulatory authorities, and statements related to our portfolio goals, business plans, and sustainability plans. Galapagos cautions 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 actual events, 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. In addition, even if Galapagos’ results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Such risks include, but are not limited to, the risk that our expectations and management’s guidance regarding our 2024 cash burn may be incorrect (including because one or more of its 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 developments, clinical trials, recruitment of patients, product development activities and regulatory approval requirements (including the risk that data from Galapagos’ ongoing and planned clinical research programs in RA, UC, DM, SLE, AxSpA, rrNHL, rSLE, rrCLL, rrMM and other indications or any other indications or diseases, may not support registration or further development of its product candidates due to safety or efficacy concerns or other reasons), 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, the risk that the transfer of the Jyseleca® business will not have the currently expected results for our business and results of operations 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 (if approved) or expectations regarding the costs and revenues associated with the commercialization rights may be inaccurate, and 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. 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 or any change in events, conditions or circumstances, unless specifically required by law or regulation.
1 Throughout this press release, ‘Dr. Paul Stoffels’ should be read as ‘Dr. Paul Stoffels, acting via Stoffels IMC BV’
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 acquisition of financial assets held at fair value through profit or loss; 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 year 2023 amounted to €414.8 million and can be reconciled to our cash flow statement by considering the decrease in cash and cash equivalents of €339.8 million, adjusted by (i) the cash proceeds from capital and share premium increase from the exercise of subscription rights by employees for €1.8 million, (ii) the net purchase of current financial investments amounting to €94.2 million, (iii) the cash-out related to the acquisition of subsidiaries of €7.0 million, and (iv) the acquisition of financial assets held at fair value through profit or loss of €14.0 million.
ii General and administrative
iii Sales and marketing
Attachments
fy23_financial_tables_en
Galapagos announces full year 2023 results and outlook for 2024
Primary Logo
abrooklyn
1年前
Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]
Source: Edgar (US Regulatory)
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 February 2024
Commission File Number: 001-37384
GALAPAGOS NV
(Translation of registrant's name into English)
Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ] Form 40-F [ ]
The information contained in this Report on Form 6-K, including Exhibit 99.1, except for the quotes of Dr Jeevan Shetty, included 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, 333-260500, 333-268756, and 333-275886).
On February 15, 2024, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
(c) Exhibit 99.1. Press release dated February 15, 2024
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: February 16, 2024 /s/ Annelies Denecker
Annelies Denecker
Company Secretary
EXHIBIT 99.1
Galapagos presents at EBMT-EHA annual meeting 2024
Showcases meaningful advances in decentralized CAR T-cell manufacturing and presents translational and clinical data from ongoing Phase 1/2 CD19 CAR-T studies
Mechelen, Belgium; 15 February 2024, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) to present new preliminary translational data and previously disclosed data at the European Society for Blood and Marrow Transplantation (EBMT)-European Hematology Association (EHA) 6th European CAR T-cell meeting taking place from 15–17 February 2024 in Valencia, Spain.
The preliminary translational data from its EUPLAGIA-1 Phase 1/2 study demonstrate that Galapagos’ differentiated point-of-care manufacturing platform offers the potential for a single infusion of fresh early-phenotype CD19 CAR-T cells with robust expansion and persistence in patients with relapsed/refractory chronic lymphocytic leukemia (rrCLL) and patients with Richter transformation (RT). Further, previously disclosed safety, efficacy and feasibility data from EUPLAGIA-1 and ATALANTA-1 support the potential of Galapagos’ innovative approach to CAR-T manufacturing and of the transformational impact on patients with severe hematologic cancers.
“At Galapagos, we are committed to accelerating transformative innovation to address the unmet needs of patients with advanced cancers, and the data we are presenting today demonstrates our positive momentum toward this goal,” said Dr Jeevan Shetty, M.D., Head of Clinical Development Oncology at Galapagos. “We are pleased for the opportunity to present encouraging data that supports the potential of our innovative, decentralized approach to CAR-T manufacturing and the transformational impact CAR-T treatment could have on patients with serious hematologic cancers.”
Summary of preliminary translational data from EUPLAGIA-1 with GLPG5201 (cut-off date: 6 September 2023):
Patient recruitment of the Phase 1 dose-finding part of EUPLAGIA-1 has been completed and 15 patients were enrolled (6 at dose level 1 (DL1); and 9 at dose level 2 (DL2)), all of whom were diagnosed with rrCLL and 9 with additional RT. All 15 Phase 1 batches were manufactured at the point-of-care and infused as a single fresh, fit product within a median vein-to-vein time of seven days, with 80% of patients receiving the product in seven days.
GLPG5201 final product showed an increase in early phenotypes of CD4+ and CD8+ CAR-T cells (naïve, stem cell memory (TN/SCM) and central memory) compared to apheresis starting material. A robust in vivo expansion of GLPG5201 occurred with a median time-to-peak expansion of 14 days, regardless of dose level, and a higher exposure for patients infused with DL2 compared to DL1. GLPG5201 expansion and exposure were similar in patients with rrCLL and in patients with RT. Persisting CAR-T cells were detected up to 15 months post-infusion. Moreover, the abundance of both CD4+ and CD8+ TN/SCM CAR-T cells in the final product correlated with CAR-T-cell exposure in patients.
Key data highlights accepted by EBMT-EHA:
Abstract Title Authors/Presenter Presentation date/time
Galapagos abstracts
Seven-Day Vein-to-Vein Point-of-Care–Manufactured GLPG5201 Anti-CD19 CAR-T Cells Display Early Phenotype in Relapsed/Refractory Chronic Lymphocytic Leukemia (rrCLL) Including Richter's Transformation (RT) Sandra Blum, Claire Vennin, Esmée P. Hoefsmit, Kirsten Van Hoorde, Sergi Betriu,
Leticia Alserawan, Julio Delgado, Nadia Verbruggen, Anna D.D. van Muyden, Henriëtte Rozema, Ruiz Astigarraga, Margot J. Pont Poster Number: AS-CART-2024-00104
Date: 15 February 2024; 8:15 pm –8:45 pm
Session: PT2 (Poster Tour 2)
Galapagos encore abstracts
Seven-Day Vein-to-Vein Point-of-Care Manufactured CD19 CAR-T Cells (GLPG5101) in Relapsed/Refractory Non-Hodgkin Lymphoma (rrNHL): Results from the Phase 1 ATALANTA-1 Trial Marie José Kersten, Kirsten Saevels, Sophie Servais, Yves Beguin, Joost S.P. Vermaat, Eva Santermans, Stavros Milatos, Maike Spoon, Marte C. Liefaard, Claire Vennin, Margot J. Pont, Anna D.D. van Muyden, Maria T. Kuipers, Sébastien Anguille
Poster Number: AS-CART-2024-00090
Date: 15 February 2024; 7:45 pm –8:15 pm
Session: PT1 (Poster Tour 1)
Seven-Day Vein-to-Vein Point-of-Care–Manufactured CD19 CAR T-Cell Therapy (GLPG5201) in Relapsed/Refractory Chronic Lymphocytic Leukemia (rrCLL) Including Richter’s Transformation: Results from the Phase 1 EUPLAGIA-1 Trial
Natalia Tovar, Nuria Martinez-Cibrian, Julio Delgado, Sergi Betriu, Leticia Alserawan, Ana Triguero, Nadia Verbruggen, Maike Spoon, Marte C. Liefaard, Anna D.D. van Muyden, Valentin Ortiz-Maldonado Oral Presentation Number: AS-CART-2024-00099
Date: 16 February 2024; 6:38 pm –6:44 pm (session runs 6:20 pm –7:15 pm)
Session: BA2 (Best Abstracts 2); Auditorium 1
Phase 1/2, Multicenter, Open-Label Study to Evaluate Feasibility, Safety and Efficacy of Point-of-Care–Manufactured Anti-BCMA CAR T-Cell Therapy (GLPG5301) in Relapsed/Refractory Multiple Myeloma (rrMM) Niels W.C.J. van de Donk, Sébastien Anguille, Jo Caers, Marte C. Liefaard, Christian Jacques, Anna D.D. van Muyden Poster Number: AS-CART-2024-00103
Date: 17 February 2024; 08:30 am–1:45 pm
Session: PE17p (Poster Exhibition)
About Galapagos’ decentralized CAR-T manufacturing platform
Galapagos’ decentralized, innovative point-of-care CAR T-cell manufacturing platform offers the potential for the administration of fresh, fit cells with a vein-to-vein time of seven days, greater physician control and a significantly improved patient experience. The platform consists of an end-to-end xCellit™ workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon®) and a proprietary quality control testing and release strategy.
About the EUPLAGIA-1 study (EudraCT 2021-003815-25)
EUPLAGIA-1 is an ongoing Phase 1/2 open-label, multi-center study evaluating the safety, efficacy and feasibility of point-of-care manufactured GLPG5201, a CD19 CAR-T product candidate, in patients with relapsed/refractory lymphocytic leukemia (rrCLL) and small cell lymphocytic lymphoma (rrSLL), with or without Richter transformation (RT). GLPG5201 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. Patients with CD19+ rrCLL or rrSLL with ≥2 lines of prior therapy are eligible to participate, and patients with RT are eligible regardless of prior therapy. The primary objective of the Phase 1 part of the study was to evaluate safety and determine the recommended dose for the Phase 2 part of the study. The dose levels that were evaluated in the Phase 1 part of the study are 35x106 (DL1), and 100x106 (DL2) CAR+ viable T cells. The primary objective of the Phase 2 part of the study is to assess the Objective Response Rate (ORR) and the secondary objectives include the analysis of the Complete Response (CR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and feasibility of point-of-care manufacturing.
About chronic lymphocytic leukemia
Chronic lymphocytic leukemia (CLL) is one of the chronic lymphoproliferative disorders (lymphoid neoplasms). It is characterized by a progressive accumulation of functionally incompetent lymphocytes, which are usually monoclonal in origin. CLL affects B-cells in the blood and bone marrow.1 RT is an uncommon clinicopathological condition observed in patients with CLL. It is characterized by the sudden transformation of the CLL into a significantly more aggressive form of large cell lymphoma and occurs in approximately 2-10% of all CLL patients. CLL usually follows an indolent course and is an incurable disease. Patients who develop relapsed and refractory disease and become resistant to new agents have a dismal prognosis and a high unmet medical need for new therapeutic options such as CAR-T cells. With estimated incidence of 4.7 new cases per 100,000 individuals, CLL is the most prevalent lymphoid malignancy and is the most common adult leukemia in the US and in Europe.2 The annual incidence of patients with RT has been estimated at 1,900 new patients in the US and 2,000 in the EU5.3
About the ATALANTA-1 study (EudraCT 2021-003272-13)
ATALANTA-1 is an ongoing Phase 1/2, open-label, multicenter study to evaluate the safety, efficacy and feasibility of point-of-care manufactured GLPG5101, a CD19 CAR-T product candidate, in patients with relapsed/refractory non-Hodgkin’s lymphoma (rrNHL). GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The primary objective of the Phase 1 part of the study was to evaluate safety and to determine the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment of efficacy and feasibility of near the point-of-care manufacturing of GLPG5101. The dose levels that were evaluated in Phase 1 are 50x106 (DL1) and 110x106 (DL2) and 250x106 (DL3) CAR+ viable T cells. The primary objective of the Phase 2 part of the study is to evaluate the Objective Response Rate (ORR) while the secondary objectives include Complete Response (CR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of point-of-care manufacturing. Each enrolled patient will be followed for 24 months.
About non-Hodgkin’s lymphoma
Non-Hodgkin’s lymphoma is a cancer originating from lymphocytes, a type of white blood cell which is part of the body’s immune system. Non-Hodgkin’s lymphoma can occur at any age although it is more common in adults over 50 years old. Initial symptoms usually are enlarged lymph nodes, fever, and weight loss. There are many different types of non-Hodgkin’s lymphoma. These types can be divided into aggressive (fast-growing) and indolent (slow-growing) types, and they can be formed from either B lymphocytes (B cells) or in lesser extent from T lymphocytes (T cells) or Natural Killer cells (NK cells). B-cell lymphoma makes up about 85% of non-Hodgkin’s lymphomas diagnosed in the US. Prognosis and treatment of non-Hodgkin’s lymphoma depend on the stage and type of disease.
About the PAPILIO-1 Phase 1/2 study (EU CT 2022-500782-27-00)
PAPILIO-1 is a Phase 1/2, open-label, multicenter study to evaluate the safety, efficacy and feasibility of point-of-care manufactured GLPG5301, a BCMA CAR-T product candidate, in patients with relapsed/refractory multiple myeloma (rrMM) after ≥2 prior lines of therapy. The primary objective of the Phase 1 part of the PAPILIO-1 study is to evaluate safety and determine the recommended dose for the Phase 2 part of the study. The primary objective of the Phase 2 part of the study is to evaluate the efficacy of GLPG5301, as measured by the Objective Response Rate (ORR). Secondary objectives for both Phase 1 and Phase 2 include further assessment of the safety of GLPG5301, additional efficacy endpoints, including assessment of Minimal Residual Disease (MRD), as well as the feasibility of point-of-care manufacture of GLPG5301 in rrMM patients. Each enrolled patient will be followed for 24 months. During Phase 1, up to 3 dose levels will be evaluated and at least 12 patients will be enrolled to establish the recommended Phase 2 dose. Approximately 30 additional patients will be enrolled in the Phase 2 part of the study to further evaluate the safety and efficacy of GLPG5301.
About relapsed/refractory multiple myeloma (rrMM)
Multiple myeloma (MM) is typically characterized by the neoplastic proliferation of plasma cells producing a monoclonal immunoglobulin. The plasma cells proliferate in the bone marrow and may result in extensive skeletal destruction with osteopenia, and osteolytic lesions with or without pathologic fractures. The diagnosis of MM is made when one (or more) of the following clinical presentations are present: bone pain with lytic lesions discovered on routine skeletal films or other imaging modalities, an increased total serum protein concentration with the presence of a monoclonal protein in the urine or serum, and anemia, hypercalcemia or renal failure. The patient may be either symptomatic or their disease may be discovered incidentally. Despite improvements in treatment, patients with MM ultimately relapse or become refractory to available regimens. Triple-refractory patients (refractory to CD38 monoclonal antibodies (mAbs), proteasome inhibitor (PI) and immunomodulatory drug (IMiD)), or penta-refractory patients (refractory to CD38 mAbs, 2 Pls and 2 IMiDs) have a poor prognosis and are in urgent need of novel treatment options.
About Galapagos
We are a global biotechnology company with operations in Europe and the US dedicated to developing transformational medicines for more years of life and quality of life. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders. For additional information, please visit?www.glpg.com?or follow us on?LinkedIn?or?X (formerly Twitter).
Contact
Media inquiries:
Marieke Vermeersch
+32 479 490 603
media@glpg.com Investor inquiries:
Sofie Van Gijsel
+1 781 296 1143
ir@glpg.com
Sandra Cauwenberghs
+32 495 58 46 63
ir@glpg.com
Forward-looking statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements are often, but are not always, made through the use of words or phrases such as “anticipate,” “expect,” “plan,” “estimate,” “will,” “continue,” “aim,” “intend,” “future,” “potential,” “could,” ”indicate,” “forward,” as well as similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements regarding preliminary, interim and topline data from the EUPLAGIA-1, ATALANTA-1 and PAPILIO-1 studies and other analyses related to CD19 CAR-T, statements related to Galapagos’ plans, expectations and strategy with respect to the EUPLAGIA-1, ATALANTA-1 and PAPILIO-1 studies, and statements regarding the expected timing, design and readouts of the EUPLAGIA-1, ATALANTA-1 and PAPILIO-1 studies, including the expected recruitment for trials. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause our actual results to be materially different from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include, without limitation, the risk that preliminary or interim clinical results may not be replicated in ongoing or subsequent clinical trials; the risk that ongoing and future clinical studies with GLPG5201 and GLPG5101 may not be completed in the currently envisaged timelines or at all, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of GLPG5201 and GLPG5101 due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties (including its collaboration partner Lonza) and that Galapagos’ estimations regarding its GLPG5201 and GLPG5101 development programs and regarding the commercial potential of GLPG5201 and GLPG5101, may be incorrect, as well as those risks and uncertainties identified in Galapagos’ Annual Report on Form 20-F for the year ended 31 December 2022 filed with the U.S. Securities and Exchange Commission (SEC) and its subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.
1 Wierda WG. Chronic lymphocytic leukemia/ Small lymphocytic lymphoma fact sheet. In: Foundation LR, editor: https://www.lymphoma.org/wp-content/uploads/2018/04/LRF_FACTSHEET_CLL_SLL.pdf.2018.
2 Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA: A Cancer Journal for Clinicians. 2021;71(1):7-33. https://www.ncbi.nlm.nih.gov/books/NBK493173
3 IMARC report, 2023; 2-15% of incidence per Lightning Health literature review; Sigmund AM et al. 2022; Thompson PhA et al. 2022
abrooklyn
1年前
Galapagos reports third quarter 2023 results and releases new encouraging data from CAR-T studies for presentation at ASH 2023
Source: GlobeNewswire Inc.
First nine months 2023 key financials:
Group revenues of €448.9 million
Jyseleca® net sales of €82.1 million
Cash and current financial investments of €3.8 billion at 30 September 2023
Full year 2023 net Jyseleca® sales guidance of €100-€120 million and cash burn guidance of €380-€420 million reiterated
Jyseleca® strategic evaluation completed: signed Letter of Intent to transfer the Jyseleca® (filgotinib) business to Alfasigma, including the European and UK Marketing Authorizations and development activities, and approximately 400 positions in 14 European countries
Oncology pipeline:
New encouraging data from ongoing CAR-T Phase 1/2 studies in relapsed/refractory chronic lymphocytic leukemia (rrCLL) and non-Hodgkin lymphoma (rrNHL) will be presented at ASH:
GLPG5201 in rrCLL: On the higher dose level, 6 of 6 patients responded to treatment (Objective Response Rate, ORR, of 100%) and 5 of 6 patients achieved a Complete Response (CRR of 83%). Overall, 11 of 12 patients responded to treatment (ORR of 92%) and 9 of 12 patients achieved a CRR (75%). 5 of 7 patients with Richter’s transformation (RT) achieved a CRR (71%). GLPG5201 shows an acceptable safety profile with no cytokine release syndrome (CRS) ≥ Grade 3 or any immune effector cell-associated neurotoxicity syndrome (ICANS) observed.
GLPG5101 in rrNHL: On the higher dose level, 5 of 6 patients achieved a CRR (83%). Overall, 11 of 13 patients responded to treatment (ORR of 85%) and 9 of 13 patients achieved a CRR (69%). GLPG5101 showed an acceptable safety profile with no CRS > Grade 3 or ICANS ≥ Grade 2 observed.
Manufacturing agreement with U.S.-based Landmark Bio marks important milestone in expanding CAR-T point-of-care network for the decentralized production in the Boston area
Immunology pipeline:
Advanced novel, oral, selective tyrosine kinase inhibitor, GLPG3667, in patients with systemic lupus erythematosus
Further progress made in initiating Phase 1b study with CD19 CAR-T candidate, GLPG5101, in patients with refractory systemic lupus erythematosus
Appointed Mr. Simon Sturge as Non-Executive Independent Director to the Board of Directors
Webcast presentation tomorrow, 3 November 2023, at 13:00 CET / 8:00 am ET, www.glpg.com
Mechelen, Belgium; 2 November 2023, 21:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) today announced its financial results for the first nine months of 2023, a year-to-date business update and its outlook for the remainder of 2023.
“We continue to be very encouraged by the safety and efficacy results observed in the ongoing Phase 1/2 studies with our CD19 CAR-T programs, GLPG5201 and GLPG5101, with additional data to be presented at the upcoming ASH conference in December. The new data released today indicate that both CAR-T candidates have the potential to improve survival for patients with a broad range of B-cell malignancies such as rrCLL and rrNHL. Moreover, the data show that our platform for the decentralized production of fresh CAR-T products, close to patients, has the potential to reduce the median vein-to-vein time to only seven days. We look forward to further building our data package following the agreement with Boston-based Landmark Bio, which is a key milestone in the geographical expansion of this unique point-of-care model and the start of clinical development of our CAR-T programs in the U.S.,” said Dr. Paul Stoffels1, CEO and Chairman of Galapagos.
“We made good progress with our small molecules clinical pipeline in immunology and dosed the first patient in the Phase 2 study with our novel, oral, selective tyrosine kinase inhibitor, GLPG3667, in systemic lupus erythematosus. We also continue to prepare for the initiation of our Phase 1b study with CD 19 CAR-T candidate, GLPG5101, in patients with refractory systemic lupus erythematosus,” concluded Dr. Paul Stoffels, CEO and Chairman of Galapagos.
“We ended the third quarter with a solid cash position of €3.8 billion and reiterate our cash burn guidance of €380-€420 million,” said Thad Huston, CFO and COO of Galapagos. “Earlier this week, we announced that we completed the strategic evaluation exercise for Jyseleca® and that we signed a letter of intent with Alfasigma for the transfer of the Jyseleca® business. This planned transaction is a major step in our transformation, allowing us to right-size our organization and focus our resources on building an R&D pipeline of transformational medicines, addressing high unmet patient needs.”
Third quarter 2023 performance and recent business update
Oncology portfolio
GLPG5201 (CD19 CAR-T) in relapsed/refractory chronic lymphocytic leukemia (CLL), with or without Richter’s transformation (RT)
The Phase 1 dose-finding part of the EUPLAGIA-1-study has been completed and preparations to start the Phase 2 dose expansion are ongoing.
New preliminary data (data cut-off: 26 April 2023), for 12 patients enrolled in EUPLAGIA-1, will be presented at ASH (see ASH abstract and poster presentation details below). All 12 patients were diagnosed with rrCLL, 7 of 12 with RT. The results included in the abstract are summarized below:
GLPG5201 showed an acceptable safety profile with most treatment emergent adverse events (TEAEs) of Grade 1 or 2. CRS Grade 1 or 2 was observed in 50% of the patients, and no CRS Grade ≥ 3 or any ICANS were observed. No deaths were reported.
11 of 12 patients responded to treatment (Objective Response Rate, ORR of 92%). 9 of 12 patients achieved a Complete Response (CRR of 75%). 5 of 7 patients with RT achieved a CRR (71%). On the higher dose level, 6 of 6 patients responded to treatment (ORR of 100%) and 5 of 6 patients achieved a CRR (83%).
Strong and consistent in vivo CAR-T expansion levels and a product consisting of early phenotype T cells were observed in all doses tested.
The data show that our point-of-care platform has the potential to deliver fresh product in a median vein-to-vein time of 7 days.
GLPG5101 (CD19 CAR-T) in relapsed/refractory non-Hodgkin lymphoma (rrNHL)
We are in the final stages of the Phase 1 dose-finding part of the ongoing Phase 1/2 ATALANTA-1 study, which enrolled patients with diffuse large B cell lymphoma (DLBCL), mantle cell lymphoma and indolent lymphoma. The Phase 2 expansion cohorts for indolent lymphoma and mantle cell lymphoma are open and the first 10 patients have been dosed. Recruitment is ongoing.
New preliminary data (data cut-off: 2 May 2023) for 14 patients enrolled in ATALANTA-1 will be presented at ASH (see ASH abstract and poster presentation details below). 7 patients had diffuse large B-cell lymphoma, 3 had follicular lymphoma, 3 had mantle cell lymphoma and 1 had marginal zone lymphoma. The results included in the abstract are summarized below:
GLPG5101 showed an acceptable safety profile with most TEAEs of Grade 1 or 2. No CRS Grade > 3 and no ICANS Grade ≥ 2 were observed. In two patients, Grade 3-4 infections were observed, and three patients experienced Grade 4 neutropenia.
One Grade 5 intra-abdominal hemorrhage occurred 12 days post infusion caused by Grade 4 disseminated intravascular coagulation. This event occurred in an elderly patient with very rapidly progressive, primary refractory, double hit DLBCL, severe comorbidities, including a medical history of pulmonary embolism pre-CAR-T treatment, complicated by a Grade 3 CRS and respiratory insufficiency. One patient developed Grade 5 sepsis at six months post infusion while the patient was in ongoing CR.
11 out of 13 evaluable patients responded to treatment (ORR of 85%) and 9 of 13 evaluable patients achieved a Complete Response (CRR of 69%). 5 of 6 patients treated with the higher dose achieved a CRR (83%). 7 of 13 patients reported an ongoing response at time of analysis, with a duration of up to 12 months (median follow-up of 4.5 months).
Strong and consistent in vivo CAR-T expansion levels and a product consisting of early phenotype T cells were observed in all doses tested.
The data show that our point-of-care platform has the potential to deliver fresh product in a median vein-to-vein time of 7 days.
Building a global CAR-T point-of-care network
We signed an agreement with Boston-based Landmark Bio and started the technology transfer for the decentralized production of our CAR-T cell therapy candidates, a key milestone to expand our CAR-T programs beyond Europe and start clinical development in the U.S.
Immunology portfolio
Jyseleca® (filgotinib) (JAK1)
Jyseleca® is reimbursed for rheumatoid arthritis (RA) and ulcerative colitis (UC) in 22 and 20 countries respectively. Sobi2, our distribution and commercialization partner in Eastern and Central Europe, Portugal, Greece, and the Baltic countries, launched Jyseleca® in Slovenia in both RA and UC, and in Poland in RA.
Pipeline programs
We dosed the first patients in the Phase 2 GALACELA study of our novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor, GLPG3667, in patients with systemic lupus erythematosus (SLE). Recruitment in the Phase 2 study in dermatomyositis is also ongoing.
We are preparing to open the first clinical centers to begin screening of patients with refractory SLE (rSLE) in the Phase 1b GALALUCA study with our CD19 CAR-T candidate, GLPG5101.
Corporate update
The Board of Directors appointed Mr. Simon Sturge as Non-Executive Independent Director by way of co-optation on 19 September 2023, replacing Dr. Mary Kerr who stepped down on 18 September 2023.
On 30 October 2023, Galapagos announced that it signed a letter of intent to transfer the Jyseleca® business to Alfasigma, including the European and UK Marketing Authorizations and development activities, and approximately 400 positions in 14 European countries. Galapagos also announced that it intends to streamline its remaining operations and further build efficiencies, with an envisaged reduction of approximately 100 positions across the organization. Completion of the intended transaction is subject to customary conditions, including consultations with works councils.
Financial highlights for the first nine months of 2023 (unaudited)
(€ millions, except basic & diluted income/loss (-) per share)
Nine months ended 30 September Change
2023 2022
Product net sales 82.1 60.5 +36%
Collaboration revenues 366.8 349.7 +5%
Total net revenues 448.9 410.2 +9%
Cost of sales (13.6) (7.9) +71%
R&D expenditure (312.2) (364.1) -14%
G&Aii and S&Miii expenses (182.2) (202.7) -10%
Other operating income 40.1 29.5 +36%
Operating loss (19.0) (135.1)
Fair value adjustments and net currency exchange differences 36.2 130.9
Net other financial result 50.4 (3.4)
Income taxes (13.5) (3.2)
Net profit/loss (-) of the period 54.1 (10.8)
Basic and diluted income/loss (-) per share (€) 0.82 (0.16)
Current financial investments and cash and cash equivalents 3,811.7 (*) 4,362.1(**)
(*) Starting from Q3 2023, our current financial investments and cash and cash equivalents include accrued interests (for a total of 21.7 million on 30 September 2023).
(**) Excluding €4.7 million of net accrued interest income.
Details of the financial results of the first nine months of 2023
Total net revenues for the nine months ended 30 September 2023 was €448.9 million, compared to €410.2 million for the nine months ended 30 September 2022, and consisted of:
Product net salesof Jyseleca®in Europe for the first nine months of 2023 amounting to €82.1 million (€60.5 million in the first nine months of 2022).
Collaboration revenuesof €366.8 million for the first nine months of 2023, compared to €349.7 million for the first nine months of 2022.
Collaboration revenues increased mainly due to revenue recognition related to the collaboration agreement with Gilead for the filgotinib development amounting to €186.0 million in the first nine months of 2023 compared to €166.8 million for the same period last year. This increase is primarily driven by a positive catch-up of revenue explained by a decrease in the total estimated remaining costs to complete the filgotinib development. This was a consequence of the topline results from the Phase 3 DIVERSITY trial with filgotinib in CD and our decision not to submit a Marketing Authorization Application in Europe.
Our deferred income balance on 30 September 2023 includes €1.4 billion allocated to our drug discovery platform that is recognized linearly over the remaining period of our 10-year collaboration, and €0.3 billion allocated to the filgotinib development that is recognized over time until the end of the development period.
Total operating loss for the nine months ended 30 September 2023 was €19.0 million, compared to total operating loss of €135.1 million for the first nine months ended 30 September 2022.
Cost of sales related to Jyseleca® net sales in the first nine months of 2023 amounted to €13.6 million (€7.9 million in the first nine months of 2022).
R&D expenditure in the first nine months of 2023 amounted to €312.2 million, compared to €364.1 million for the first nine months of 2022. This decrease was primarily explained by lower personnel costs due to lower bonuses and cost of subscription right plans, lower external outsourcing costs and lower depreciation costs. This decrease in depreciation costs was primarily due to an impairment recorded in the first nine months of 2022 of €26.7 million of previously capitalized upfront fees related to our collaboration with Molecure on the dual chitinase inhibitor OATD-01 (GLPG4716).
S&M and G&A expenses amounted to €182.2 million in the first nine months of 2023, compared to €202.7 million in the first nine months of 2022. This decrease was primarily due to a decrease in personnel costs and agency deliverables.
Other operating income amounted to €40.1 million in the first nine months of 2023, compared to €29.5 million for the same period last year, mainly due to higher grant income.
Net financial income in the first nine months of 2023 amounted to €86.6 million, compared to net financial income of €127.5 million for the first nine months of 2022.
Fair value adjustments and net currency exchange gains in the first nine months of 2023 amounted to €36.2 million, compared to fair value adjustments and net currency exchange gains of €130.9 million for the first nine months of 2022, and were primarily attributable to €33.7 million of positive changes in fair value of current financial investments (compared to 26.0 million for the first nine months of 2022), and €3.5 million of unrealized currency exchange gains on our cash and cash equivalents and current financial investments at amortized cost in U.S. dollars (compared to €102.1 million for the first nine months of 2022).
Net other financial income in the first nine months of 2023 amounted to €50.4 million, compared to net other financial expenses of €3.4 million for the first nine months of 2022, and was primarily attributable to €54.6 million of interest income, which increased significantly due to the increase in interest rates.
We reported a group net profit for the first nine months of 2023 of €54.1 million, compared to a group net loss of €10.8 million for the first nine months of 2022.
Cash position
Current financial investments and cash and cash equivalents totaled €3,811.7 million on 30 September 2023, as compared to €4,094.1 million on 31 December 2022 (excluding €9.9 million of net accrued interest income).
Total net decrease in cash and cash equivalents and current financial investments amounted to €282.4 million during the first nine months of 2023, compared to a net decrease of €341.1 million during the first nine months of 2022. This net decrease was composed of (i) €343.8 million of operational cash burn, offset by (ii) €3.5 million of positive exchange rate differences, (iii) €1.8 million of cash proceeds from capital and share premium increase from exercise of subscription rights in the first nine months of 2023, (iv) €24.5 million positive changes in fair value of current financial investments and (v) €20.2 million of accrued interest income on term deposits and €11.4 million accrued interest income on treasury bills.
Outlook 2023
Financial outlook
We reiterate our full year 2023 net sales guidance for Jyseleca® of €100-€120 million and full year 2023 cash burn guidance in the range of €380-€420 million.
R&D outlook
Oncology pipeline
We expect to include the first patient in the PAPILIO-1 Phase 1/2 study evaluating the feasibility, safety, and efficacy of our point-of-care manufactured BCMA CAR-T candidate, GLPG5301, in relapsed/refractory multiple myeloma (rrMM) in the coming weeks. The study will be conducted in centers across Europe.
Three abstracts on our CAR-T portfolio in hemato-oncology have been selected for poster presentations at the 65th Society of Hematology (ASH) Annual Meeting and exposition conference taking place on 9-12 December in San Diego, California (see details below). The two presentations on EUPLAGIA-1 and ATALANTA-1 will include more recent data updates and additional data not found in the ASH abstracts. One presentation will outline the clinical study design of the PAPILIO-1 Phase 1/2 study.
Following the point-of-care manufacturing agreement with Boston-based Landmark Bio, we expect to submit an Investigational New Drug Application in the U.S. to start clinical development with our CD19 CAR-T programs in the first half of 2024.
Immunology portfolio
Pending approval of the Clinical Trial Application submitted in the European Union for our CD19 CAR-T candidate, GLPG5101, in patients with rSLE, we expect to open the first clinical centers and begin screening patients with rSLE in early 2024.
Business development
We will continue to extensively evaluate various product candidates and business development opportunities to further leverage our internal capabilities and accelerate and expand our product portfolio.
Conference call and webcast presentation
We will host a conference call and webcast presentation tomorrow 3 November 2023, at 13:00 CET / 8:00 am ET. To participate in the conference call, please register in advance using this link, after which the dial-in numbers will be provided. The conference call can be accessed 10 minutes prior to the start by using the conference access information provided in the email after registration, 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.
ASH presentation details
Abstract Title Authors Presentation details
Seven-day Vein-to-Vein Point-of-Care Manufactured CD19 CAR T Cells (GLPG5201) in Relapsed/Refractory CLL/SLL including Richter’s Transformation: Results from the Phase 1 Euplagia-1 Trial Natalia Tovar, Valentin Ortiz-Maldonado, Nuria Martinez-Cibrian, Sergi Betriu, Daniel Esteban, Ana Triguero, Nadia Verbruggen, Anna D.D. van Muyden, Maike Spoon, Margot J. Pont Abstract
Poster Number: 2112
Date: 9 Dec 2023, 5:30–7:30 pm
Session: Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I
Seven-day Vein-to-Vein Point-of-Care Manufactured CD19 CAR T Cells (GLPG5101) in Relapsed/Refractory NHL: Results from the Phase 1 Atalanta-1 Trial Marie José Kersten, Kirsten Saevels, Sophie Servais, Yves Beguin, Joost Vermaat, Nadia Verbruggen, Anna DD Van Muyden, Margot J Pont, Maria T Kuipers, Sébastien Anguille Abstract
Poster Number: 2113
Date: 9 Dec 2023, 5:30–7:30 pm
Session: Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I
Rationale for and Design of Papilio-1: a Phase 1/2, Multicenter, Open-Label Study to Evaluate the Feasibility, Safety, and Efficacy of Point-of-Care–Manufactured Anti–B-Cell Maturation Antigen Chimeric Antigen Receptor T Cells (GLPG5301) in Relapsed/Refractory Multiple Myeloma Niels van der Donk, Sebastien Anguille, Jo Caers, Marte C. Liefaard, Christian Jacques, Anna D.D. van Muyden Abstract
Poster Number: 4859
Date: 11 Dec 2023, 6:00–8:00 pm
Session: Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster III
Financial calendar 2024
22 February 2024
28 March 2024
30 April 2024
2 May 2024
1 August 2024
30 October 2024 Full year 2023 results
Annual report 2023
Annual Shareholders’ Meeting
First quarter 2024 results
Half-year 2024 results
Third quarter 2024 results (webcast 23 February 2024)
(webcast 3 May 2024)
(webcast 2 August 2024)
(webcast 31 October 2024)
About Galapagos
We are a global biotechnology company with operations in Europe and the US dedicated to developing transformational medicines for more years of life and quality of life. Focusing on high unmet medical needs, we synergize the most compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders. For additional information, please visit www.glpg.com or follow us on LinkedIn or X (formerly 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 moderate to severe active 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.
Contact
Media inquiries:
Marieke Vermeersch
+32 479 490 603
media@glpg.com Investor inquiries:
Sofie Van Gijsel
+1 781 296 1143
ir@glpg.com
Sandra Cauwenberghs
ir@glpg.com
Forward-looking statements
This release may contain 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 “anticipate,” “on track,” “expect, ” “encouraging,” “expand,” “advance,” “plan,” “estimate,” “will,” “continue,” “aim,” “intend,” “future,” “guidance,” “outlook,”, ”indicate”, “forward,” as well as similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements made in the sections captioned “Third quarter 2023 performance and recent business update” and “Outlook 2023”, the guidance from management regarding our expected operational use of cash and estimated peak sales for Jyseleca® during the financial year 2023, statements related to the contemplated transaction between Galapagos and Alfasigma and the planned reduction in force, statements regarding our strategic and capital allocation priorities, including progress on our immunology or oncology portfolio, our CAR-T-portfolio and our SIKi-portfolio, and potential changes of such plans, statements regarding our pipeline and complementary technology platforms facilitating future growth, statements regarding our regulatory and R&D outlook, statements regarding the expected timing, design and readouts of ongoing and planned clinical trials, including but not limited to (i) filgotinib in juvenile arthritis, (ii) GLPG5101 in rrNHL and rSLE, (iii) GLPG5201 in rrCLL, and (iv) GLPG5301 in rrMM, statements regarding our commercialization efforts for filgotinib, our product candidates, and any of our future approved products, if any, statements regarding our expectations on commercial sales of filgotinib and any of our product candidates (if approved), statements related to the timing for submission of an Investigational New Drug application and the clinical development of our CAR-T program in the United States, and statements related to our portfolio goals and business plans. Any forward-looking statements in this release are based on management’s current expectations and beliefs and are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause our actual results, financial condition and liquidity, performance or achievements to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. Such risks include, but are not limited to, the risk that our expectations regarding our 2023 revenues, operating expenses, cash burn and other financial estimates may be incorrect (including because one or more of our assumptions underlying our revenue and 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 developments, clinical trials, recruitment of patients, product development activities and regulatory approval requirements (including the risk that data from our ongoing and planned clinical research programs in RA, UC, DM, SLE, AxSpA, refractory/relapsed NHL, rrCLL, rrSLL, rrMM and other immunologic indications or any 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, the risk that the preliminary and topline data from the OLINGUITO, ATALANTA-1, EUPLAGIA-1, GALARISSO, TORTUGA, PAPILIO-1, GALALUCA and GALACELA-studies may not be reflective of the final data, risks related to our reliance on collaborations with third parties (including, but not limited to, our collaboration partners Gilead and Lonza), risks related to the implementation of the transition of the European commercialization responsibility of filgotinib from Gilead to us, including the transfer 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 our plans with respect to CAR-T may not be achieved on the currently anticipated timeline or at all, the risk that our estimates of the commercial potential of our product candidates or expectations regarding the costs and revenues associated with the commercialization rights may be inaccurate, 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, the risks related to our strategic transformation, 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 potential disruptions in our operations, the risk that the EMA may impose JAK class-based warnings, and the risk that the EMA’s safety review may negatively impact acceptance of filgotinib by patients, the medical community, and healthcare payors, the risk that regulatory authorities may require additional post-approval trials of filgotinib or any other product candidates that are approved in the future. A further discussion 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 other 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 our results, performance, financial condition and liquidity, and the development of the industry in which we operate are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. 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 unless 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, in 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 2023 amounted to €343.8 million and can be reconciled to our cash flow statement by considering the decrease in cash and cash equivalents of €348.1 million, adjusted by (i) the cash proceeds from capital and share premium increase from the exercise of subscription rights by employees for €1.8 million, and (ii) the net purchase of current financial investments amounting to €6.1 million.
ii General and administrative
iii Sales and marketing
Addendum
Consolidated statements of income and comprehensive income/loss (-) (unaudited)
Consolidated income statement
Nine months ended
30 September
(thousands of €, except per share data) 2023 2022
Product net sales 82,075 60,491
Collaboration revenues 366,773 349,669
Total net revenues 448,848 410,160
Cost of sales (13,540) (7,938)
Research and development expenditure (312,180) (364,067)
Sales and marketing expenses (88,147) (105,313)
General and administrative expenses (94,022) (97,373)
Other operating income 40,086 29,474
Operating loss (18,954) (135,056)
Fair value adjustments and net currency exchange differences 36,247 130,900
Other financial income 55,122 9,675
Other financial expenses (4,767) (13,074)
Profit/loss (-) before tax 67,648 (7,555)
Income taxes (13,510) (3,229)
Net profit/loss (-) 54,138 (10,784)
Net profit/loss (-) attributable to:
Owners of the parent 54,138 (10,784)
Basic and diluted income/loss (-) per share 0.82 (0.16)
Consolidated statement of comprehensive income/loss (–)
Nine months ended
30 September
(thousands of €) 2023 2022
Net profit/loss (-) 54,138 (10,784)
Items that may be reclassified subsequently to profit or loss:
Translation differences, arisen from translating foreign activities 318 (7)
Other comprehensive income/loss (-), net of income tax 318 (7)
Total comprehensive income/loss (-) attributable to:
Owners of the parent 54,456 (10,791)
Consolidated statements of financial position (unaudited)
30 September 31 December
(thousands of €) 2023 2022
Assets
Goodwill 69,863 69,813
Intangible assets other than goodwill 132,313 146,354
Property, plant and equipment 136,803 154,252
Deferred tax assets 1,232 1,363
Non-current R&D incentives receivables 138,121 119,941
Other non-current assets 16,911 5,778
Non-current assets 495,244 497,501
Inventories 55,605 52,925
Trade and other receivables 46,918 40,429
Current R&D incentives receivables 26,126 26,126
Current financial investments 3,652,333 3,585,945
Cash and cash equivalents 159,375 508,117
Other current assets 15,735 23,307
Current assets 3,956,092 4,236,850
Total assets 4,451,336 4,734,351
Equity and liabilities
Share capital 293,937 293,604
Share premium account 2,736,993 2,735,557
Other reserves (4,932) (4,853)
Translation differences (1,196) (1,593)
Accumulated losses (403,242) (496,689)
Total equity 2,621,560 2,526,026
Retirement benefit liabilities 2,408 5,540
Deferred tax liabilities 25,325 20,148
Non-current lease liabilities 8,469 14,692
Other non-current liabilities 31,449 21,808
Non-current deferred income 1,318,090 1,623,599
Non-current liabilities 1,385,741 1,685,787
Current lease liabilities 5,678 7,209
Trade and other liabilities 121,129 148,675
Current tax payable 1,764 1,022
Current deferred income 315,465 365,631
Current liabilities 444,036 522,538
Total liabilities 1,829,776 2,208,325
Total equity and liabilities 4,451,336 4,734,351
Consolidated cash flow statements (unaudited)
Nine months ended
30 September
(thousands of €) 2023 2022
Net profit/loss (-) of the period 54,138 (10,784)
Adjustment for non-cash transactions 44,344 (25,707)
Adjustment for items to disclose separately under operating cash flow (40,165) 1,599
Adjustment for items to disclose under investing and financing cash flows (11,809) (1,700)
Change in working capital other than deferred income (50,329) 57,472
Cash used for other liabilities related to the acquisition of subsidiaries - (11,080)
Decrease in deferred income (359,259) (318,167)
Cash used in operations (363,081) (308,367)
Interest paid (3,729) (10,940)
Interest received 35,063 2,262
Corporate taxes paid (7,357) (3,637)
Net cash flows used in operating activities (339,104) (320,682)
Purchase of property, plant and equipment (11,073) (19,808)
Purchase of and expenditure in intangible fixed assets (222) (9,308)
Proceeds from disposal of property, plant and equipment 2,304 719
Purchase of current financial investments (2,615,112) (2,505,688)
Investment income received related to current financial investments 9,857 1,181
Sale of current financial investments 2,609,023 1,394,549
Cash out from acquisition of subsidiaries, net of cash acquired - (115,270)
Cash advances and loans to third parties - (10,000)
Net cash flows used in investing activities (5,222) (1,263,625)
Payment of lease liabilities (5,580) (6,263)
Proceeds from capital and share premium increases from exercise of subscription rights 1,770 6,695
Net cash flows generated from/used in (-) financing activities (3,810) 432
Decrease in cash and cash equivalents (348,136) (1,583,875)
Cash and cash equivalents at beginning of year 508,117 2,233,368
Decrease in cash and cash equivalents (348,136) (1,583,875)
Effect of exchange rate differences on cash and cash equivalents (607) 26,026
Cash and cash equivalents at end of the period 159,375 675,519
30 September
(thousands of €) 2023 2022
Current financial investments 3,652,333 3,686,557
Cash and cash equivalents 159,375 675,519
Current financial investments and cash and cash equivalents 3,811,708 4,362,076
Consolidated statements of changes in equity (unaudited)
(thousands of €) Share capital Share premium account Translation differences Other reserves Accumulated losses Total
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 293,604 2,735,557 (1,046) (10,860) (326,905) 2,690,351
On 1 January 2023 293,604 2,735,557 (1,593) (4,853) (496,689) 2,526,026
Net profit 54,138 54,138
Other comprehensive income/loss (-) 397 (79) 318
Total comprehensive income/loss (-) 397 (79) 54,138 54,456
Share-based compensation 39,308 39,308
Exercise of subscription rights 333 1,437 1,770
On 30 September 2023 293,937 2,736,993 (1,196) (4,932) (403,242) 2,621,560
1 Throughout this press release, ‘Dr. Paul Stoffels’ should be read as ‘Dr. Paul Stoffels, acting via Stoffels IMC BV’
2 Swedish Orphan Biovitrum AB
Attachment
Galapagos reports third quarter 2023 results and releases new encouraging data from CAR-T studies for presentation at ASH 2023
Primary Logo
abrooklyn
2年前
Galapagos announces full year 2022 results and outlook for 2023
Source: GlobeNewswire Inc.
Key 2022 and post-period events
Dr. Paul Stoffelsi appointed as Chief Executive Officer and Chairman of the Board of Directors
Implemented new strategic direction to accelerate innovation and time-to-patients:
Set-up of new innovation model and fit-for-purpose R&D organization
Focus on key therapeutic areas of immunology and oncology
Discontinuation of activities in fibrosis and kidney disease
Expansion of drug modalities beyond small molecules, including biologicals and CAR-T
Entered into the field of oncology through the acquisitions of CellPoint and AboundBio
Presented encouraging initial safety and efficacy data from two ongoing Phase 1/2 studies in patients with refractory/relapsed non-Hodgkins lymphoma (NHL) and chronic lymphocytic leukemia (CLL) with CD19 CAR-T candidates, GLPG5101 and GLPG5201, manufactured at point-of-care
Jyseleca® sales of €87.6 million, at the upper end of the guidance of €80-90 million
Jyseleca® reimbursed for rheumatoid arthritis (RA) in 15 countries and for ulcerative colitis (UC) in 11 countries
The Committee for Medicinal Products for Human Use (CHMP) adopted the Pharmacovigilance Risk Assessment Committee (PRAC)’s recommendation to harmonize the European label of all approved JAK inhibitors for chronic inflammatory disorders following an extensive safety review (Article 20 procedure)
Received positive opinion from the CHMP for Jyseleca® European label update based on testicular function safety data from MANTA/RAy semen parameter studies
Announced topline results from 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
2022 financial results
Group net revenues of €505.3 million compared to €484.8 million in 2021
Operating loss of €267.5 million compared to €165.6 million in 2021
Net loss of €218.0 million compared to €103.2 million in 2021
Cash and current financial investments of €4.1 billion on 31 December 2022
Operational cash burnii of €513.8 million, which is within the guided range
Webcast presentation tomorrow, 24 February 2023, at 14.00 CET / 8 AM ET, www.glpg.com
Mechelen, Belgium; 23 February 2023, 22.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) reports 2022 results, supported by strong adoption of Jyseleca® across Europe, and provides outlook for 2023.
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 ASH1 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)
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 commercialized programs in immunology, oncology, and other indications. Our first medicine for rheumatoid arthritis and ulcerative colitis is available in Europe 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 moderate to severe 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.
Contacts
Media relations Investor relations
Marieke Vermeersch Sofie Van Gijsel
+32 479 490 603 +1 781 296 1143
Elisa Chenailler Sandra Cauwenberghs
+41 79 853 33 54 +32 495 58 46 63
ir@glpg.com
Hélène de Kruijs
+31 6 22463921
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,” “continue,” “should,” “encouraging,” “aim,” “progress,” “remain,’ “explore,” “further” as well as similar expressions. These statements include, but are not limited to, statements made in the sections captioned “2022 operational review and post-period events” and “Outlook 2023”, the guidance from management regarding our financial results (including guidance regarding the expected operational use of cash and estimated peak sales for Jyseleca® during the financial year 2023), 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 outlook, statements regarding the amount and timing of potential future milestones, and other payments , statements regarding our R&D plans, strategy and outlook, including progress on our immunology or oncology portfolio, CAR-T-portfolio and our SIKi portfolio, and potential changes in such strategy, statements regarding our pipeline and complementary technology platforms facilitating future growth, statements regarding our commercialization efforts for filgotinib, our product candidates, and any of our future approved products, statements regarding our expectations on commercial sales of filgotinib and any of our product candidates (if approved), 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 our ongoing and planned preclinical studies and clinical trials, including but not limited to (i) filgotinib in RA, UC and AxSpA, (ii) with SIKi compounds, including GLPG3667 in SLE and DM, (iii) GLPG2737 in autosomal dominant polycystic kidney disease (ADPKD), (iv) GLPG5101 in rrNHL and rSLE, (v) GLPG5201 in rrCLL and rrSLL, and (vi) GLPG5301 in rrMM, including recruitment for trials and topline results for trials and studies in our portfolio, statements relating to interactions with regulatory authorities, 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 under Article 20 of Regulation (EC) No 726/2004 and regarding the related CHMP opinion, statements regarding the CHMP opinion for filgotinib, statements about the European label update based on testicular function safety data from MANTA/RAy studies, statements relating to the timing or likelihood of additional regulatory authorities’ approval of marketing authorization for filgotinib for RA, UC or any other indication, statements regarding the changes in our leadership and expected resulting benefits, the timing or likelihood of pricing and reimbursement interactions for filgotinib, statements relating to the development of our commercial organization, statements and expectations regarding the rollout of our products or product candicates (if approved) in Europe, statements related to the expected reimbursements for Jyseleca®, statements regarding patient enrollment for the Phase 2 programs with our TYK2 inhibitor product candidate, GLPG3667, and the timing for the start of a study in SLE, statements regarding the timing of clinical development with our CD19 CAR-T candidate, GLPG5101, in rSLE, statements regarding the progress of patient recruitment efforts in the European sites of the Phase 1/2 ATALANTA-1 study with our CD19 CAR-T candidate, GLPG5101, in rrNHL as well as in the EUPLAGIA-1 study with our CD19 CAR-T candidate, GLPG5201, in rrCLL/SLL, and the timing for Phase 1 topline results from such studies, statements regarding the timing for expansion of, and patient enrollment in, the CAR-T portfolio with a BCMA CAR-T product candidate, GLPG5301, in refractory/relapsed multiple myeloma (rrMM), and portfolio goals, business plans, and sustainability plans. Galapagos cautions 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 actual events, 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. In addition, even if Galapagos’ results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Such risks include, but are not limited to, the risk that our expectations and management’s guidance regarding our 2023 revenues, operating expenses, cash burn and other financial results may be incorrect (including because one or more of its 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 developments, clinical trials, recruitment of patients, product development activities and regulatory approval requirements (including the risk that data from Galapagos’ ongoing and planned clinical research programs in rheumatoid arthritis, ulcerative colitis, dermatomyositis, systemic lupus erythematosus, axial spondyloarthritis, autosomal dominant polycystic kidney disease, refractory/relapsed Non-Hodgkin lymphoma, refractory/replapsed chronic lymphocytic leukemia, refractory/replapsed small lymphocytic lymphoma, refractory/relapsed Multiple Myeloma and other immunologic indications or any other indications or diseases, may not support registration or further development of its 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, but not limited to, our collaboration partner Gilead), the risks related to the timing and implementation of the transition of the European commercialization responsibility of filgotinib from Gilead to us, including the transfer of the supply chain, the risk that the transition will not have the currently expected results for our business and results of operations 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 be unable to successfully achieve the anticipated benefits from our leadership transition, the risk that we will encounter challenges retaining or attracting talent, risks related to disruption in our operations, supply chain or ongoing studies due to the conflict between Russia and Ukraine, 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, the risk that the EMA may impose JAK class-based warnings, and the risk that the EMA’s planned safety review may negatively impact acceptance of filgotinib by patients, the medical community, and healthcare payors, the risk that regulatory authorities may require additional post-approval trials of filgotinib or any other product candidates that are approved in the future, 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.
1 Annual Society of Hematology
2 European Society for Blood and Marrow Transplantation (EBMT)-European Hematology Association (EHA)
i Throughout this press release, ‘Dr. Paul Stoffels’ should be read as ‘Dr. Paul Stoffels, acting via Stoffels IMC BV’
ii 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 year 2022 amounted to €513.8 million and can be reconciled to our cash flow statement by considering the decrease in cash and cash equivalents of €1,747.5 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 €1,087.0 million, and (iii) the cash out from acquisition of subsidiaries, net of cash acquired, of €153.4 million
iii General and administrative
iv Sales and marketing
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Galapagos announces full year 2022 results and outlook for 2023
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