GLPG3667 met primary endpoint in dermatomyositis study, demonstrating a statistically significant clinical benefit and meaningful improvements on secondary measures of disease activity compared to placebo In the systemic lupus erythematosus study, GLPG3667 delivered numerical improvements on several secondary endpoints compared to placebo but did not achieve statistical significance in primary endpoint analysis The safety profile was consistent with previous studies with GLPG3667 Galapagos will evaluate al ...

Financial Data and Key Metrics Changes - Total operating loss from continuing operations for the first nine months of 2025 amounted to EUR 462.2 million, compared to an operating loss of EUR 125.6 million for the same period in 2024 [24] - Net other financial income for the first nine months of 2025 was EUR 30.4 million, down from EUR 71.7 million in the same period of 2024 [25] - Cash and cash equivalents and current financial investments totaled EUR 3.05 billion on September 30, 2025, compared to EUR 3.32 billion on December 31, 2024 [26] Business Line Data and Key Metrics Changes - The company intends to wind down the self-therapy business due to significant ongoing investment requirements and lack of viable acquisition proposals [6][7] - The remaining organization will focus on transformational business development and maintaining a dedicated presence at headquarters in Mechelen, Belgium [10] Market Data and Key Metrics Changes - The cash balance of approximately EUR 3 billion represents about EUR 46 per share, generating significant interest income [12] - The company expects to receive tax receivables of approximately EUR 20 million to EUR 35 million per year over the next three years [13] Company Strategy and Development Direction - The company is undergoing a transformation, focusing on business development and rebuilding its pipeline after the decision to wind down the self-therapy business [4][5] - The strategy includes identifying and executing on opportunities that can enhance the standard of care in various diseases, particularly in partnership with Gilead [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, emphasizing the importance of a disciplined approach to business development and the potential for significant value creation [28] - The company anticipates being cash flow neutral to positive by the end of 2026, excluding any business development activities [27] Other Important Information - The company has welcomed four new board members to enhance its leadership team [9] - The wind-down process is expected to conclude in the first quarter of 2026, with consultations ongoing with works councils in Belgium and the Netherlands [11] Q&A Session Summary Question: What assumptions are behind the expectation of achieving cash flow neutral status by year-end 2026? - The assumptions include interest income based on forward rates, tax credits, and the completion of the wind-down process [30] Question: What types of opportunities are in the deal funnel? - The focus is on clinically de-risked mid to late-stage opportunities, particularly in oncology and immunology, with a preference for collaboration with Gilead [31][32] Question: How does the company balance being conservative with pursuing business development? - The company aims to leverage its cash balance and existing assets while ensuring any new opportunities create a positive return [33] Question: What expectations does the company have for Gilead's contribution to the deal process? - Gilead is expected to provide expertise in diligence and potentially contribute capital for development [35] Question: What is the timeline for the wind-down process of the cell therapy business? - The wind-down process is expected to be concluded in Q1 2026, with the company open to viable proposals during this time [44] Question: Will potential transactions bring in R&D capabilities? - The company is flexible regarding R&D capabilities, considering both acquiring teams and funding external parties [50]

Strategic Transformation - Galapagos is executing a strategic transformation, including the intention to wind down the cell therapy business, subject to works council consultations[13, 17] - The company expects to be cash flow neutral to positive by YE26, excluding BD and currency fluctuations[18] - A lean organization of 35-40 employees is expected by YE26, focused on transformative business development[18, 60] Financial Performance & Outlook - Nine-month total revenues increased by 6% to €211.4 million[64] - R&D expenses increased by 48% to €351.9 million[64] - An impairment loss of €204.8 million was recorded for the Cell Therapy business[64, 70] - The company anticipates approximately €2.975 - €3.025 billion in cash and investments at YE25[24] Business Development Strategy - Business development is a core strategy, leveraging a unique partnership with Gilead[37, 38] - The company is open to opportunities across diseases, modalities, geographies, and deal types[51] - A disciplined approach to capital deployment aims to maximize near- and long-term value creation[39, 40]

Core Insights - Galapagos NV has concluded its strategic review process, deciding to wind down its cell therapy business to optimize capital allocation for a sustainable future [1][4] - The company has a robust balance sheet with €3.05 billion in cash and financial investments as of September 30, 2025, and expects to end the year with approximately €2.975 billion to €3.025 billion [1][15] - Leadership changes have been made to align with the new strategic direction, enhancing corporate and business development capabilities [3][6] Financial Performance - Total net revenues for the first nine months of 2025 reached €211.4 million, a 6% increase from €200.1 million in the same period of 2024 [5][9] - The company reported an operating loss of €462.2 million for the first nine months of 2025, significantly higher than the €125.6 million loss in the same period of 2024, primarily due to a €204.8 million impairment related to the cell therapy business [7][10] - Net loss from continuing operations was €463.0 million for the first nine months of 2025, compared to a net loss of €20.4 million for the same period in 2024 [10][12] Strategic Focus - The management aims to strategically deploy capital in a disciplined manner, focusing on value-accretive transactions, particularly in small molecule and biologics programs in immunology and oncology [1][4] - The company is actively evaluating opportunities and believes its partnership with Gilead provides a strategic advantage in pursuing these opportunities [1][4] Operational Changes - The wind down of the cell therapy business is expected to impact approximately 365 employees across various locations, with the remaining organization projected to consist of 35-40 employees by the end of 2026 [4][15] - The company anticipates being cash flow neutral to positive by the end of 2026, excluding any business development activities and currency fluctuations, if the wind down is successfully implemented [1][15] Clinical Pipeline - Galapagos is advancing its clinical pipeline, including GLPG5101, a CD19 CAR-T candidate in Phase 1/2 trials, and GLPG3667, a small molecule TYK2 inhibitor in Phase 3-enabling studies [5][6]

Core Viewpoint - Galapagos NV is set to present new in vitro pharmacological data for its selective TYK2 inhibitor, GLPG3667, at the ACR Convergence 2025, highlighting its differentiation from other TYK2 inhibitors in clinical dose regimens [1][2]. Group 1: Study Overview - GLPG3667 is currently being evaluated in two Phase 3-enabling studies for systemic lupus erythematosus (SLE) and dermatomyositis (DM) [5]. - The GALACELA study is a randomized, double-blind, placebo-controlled trial assessing GLPG3667's efficacy and safety in adults with active SLE over 48 weeks [6]. - The GALARISSO study is also a randomized, double-blind, placebo-controlled trial focusing on GLPG3667's efficacy and safety in adults with DM over 24 weeks [9]. Group 2: Key Findings - At the clinical dose of 150 mg once daily, GLPG3667 demonstrated comparable inhibition of the IFN-α and IL-23 pathways to currently approved TYK2 inhibitors, with a more pronounced inhibition of the IL-12 pathway [7]. - GLPG3667 showed no measurable inhibition of IL-10-mediated signaling at concentrations significantly above clinical levels, unlike other TYK2 inhibitors [7]. - The primary endpoint for the GALACELA study is the proportion of patients achieving the SLE responder index (SRI)-4 response at Week 32, with secondary endpoints including various lupus assessment scores [6][8].

Core Insights - The company has appointed a new CEO, CFO, and experienced business development leaders to enhance shareholder value and expand its pipeline [1][2] - Strategic alternatives for the cell therapy business, including a potential divestiture, are under evaluation, while CAR-T programs show positive clinical momentum [1][3] - The company reported a strong cash position of €3.1 billion as of June 30, 2025, providing a solid foundation for growth [1][2] Strategic and Corporate Update - The Board of Directors decided to re-evaluate the previously proposed separation of the company into two entities, focusing on maximizing shareholder value [3][10] - Galapagos Cell Therapeutics has been established as a standalone entity to consolidate all cell therapy activities [3] - Morgan Stanley is acting as a financial advisor for the strategic review process [3] Leadership Changes - Henry Gosebruch has been appointed as CEO, succeeding Dr. Paul Stoffels, and Aaron Cox as CFO, succeeding Thad Huston [3] - Additional leadership appointments include Sooin Kwon as Chief Business Officer and Dan Grossman as Chief Strategy Officer, effective August 4, 2025 [3] Financial Performance - Total net revenues for the first half of 2025 were €140.3 million, unchanged from the same period in 2024 [6][13] - R&D expenses increased by 91% to €278.0 million, primarily due to higher personnel costs and costs related to cell therapy programs [6][13] - The company reported a net loss of €259.1 million for the first half of 2025, compared to a net profit of €99.2 million in the same period of 2024 [9][16] Cell Therapy Pipeline - Galapagos is advancing its cell therapy pipeline, with promising data for GLPG5101 (CD19 CAR-T) showing a 97% complete response rate in a cohort of patients with relapsed/refractory indolent non-Hodgkin lymphoma [8] - The company is also exploring partnership opportunities for GLPG3667, a small molecule TYK2 inhibitor currently in Phase 3-enabling studies [8] Financial Guidance - The company plans to provide an updated cash outlook for 2025 during its third-quarter results, following recent leadership changes and strategic evaluations [19]