Core Viewpoint - Gilead Sciences is acquiring Ouro Medicines for $2.2 billion, marking its entry into the T-cell engager (TCE) market and strengthening its partnership with Galapagos [1] Group 1: Acquisition Details - Gilead will pay $1.68 billion upfront and up to $500 million in milestone payments for Ouro's BCMA/CD3-targeting TCE, gamgertamig (OM336), which is in clinical development for immune-mediated orphan diseases [2] - The acquisition aligns with Gilead's strategy to diversify beyond HIV and complements the autoimmune initiatives of its subsidiary, Kite [3] Group 2: Partnership with Galapagos - Galapagos may participate in the acquisition by covering half of the upfront and milestone payments and costs related to registrational trials for gamgertamig, while gaining 20-23% of net sales outside of greater China if the drug reaches the market [4] - The acquisition could enhance Galapagos' pipeline strategy as it restructures following the closure of its cell therapy unit [6] Group 3: Galapagos' Future Plans - Galapagos plans to utilize its €3 billion ($3.5 billion) cash reserves to acquire late-stage assets in immunology and oncology, moving away from cell therapies [7] - Currently, Galapagos is developing GLPG3667, an oral TYK2 blocker for systemic lupus erythematosus (SLE) and dermatomyositis, which has shown mixed efficacy in mid-stage trials [8] Group 4: T-cell Engagers in the Industry - Historically, TCEs have been developed primarily for oncology, with notable approvals for drugs like Johnson & Johnson's Tecvayli and AbbVie & Genmab's Epkinly in multiple myeloma and B-cell lymphomas [9]

Core Insights - Galapagos is undergoing a strategic reset, focusing on business development in inflammation & immunology and oncology, while winding down its cell therapy activities [4][7][17] Financial Performance - The company reported an operating profit of €295.1 million for 2025, primarily due to the recognition of €1.069 billion in deferred income from Gilead [5][8] - Galapagos ended 2025 with approximately €2.998 billion in cash, down from €3.317 billion at the end of 2024, with a significant portion held in U.S. dollars [11][12] Research and Development - The TYK2 inhibitor GLPG3667 achieved positive Phase 2 results in dermatomyositis and systemic lupus erythematosus, but the company lacks the infrastructure for Phase 3 trials and is seeking partners for further development [6][7] Strategic Direction - The company is prioritizing "clinically de-risked opportunities" and leveraging its collaboration with Gilead as a strategic advantage [2][4] - A new leadership team has been assembled, and the board has been refreshed with directors experienced in capital allocation and operations [3][4] Future Guidance - For 2026, the company expects to be cash flow neutral to positive by year-end, with a projected cash outflow of up to €50 million in Q1 related to the wind-down of cell therapy [13][15] - The wind-down of cell therapy activities is expected to be substantially completed by the end of Q3 2026 [13][16]

Financial Data and Key Metrics Changes - Total operating profit from continuing operations amounted to EUR 295.1 million in 2025, compared to an operating loss of EUR 188.3 million in 2024, primarily due to the release of EUR 1,069 million in deferred income related to Gilead [8][9] - Financial investments in cash and cash equivalents totaled EUR 2,998 million on December 31, 2025, down from EUR 3,317.8 million on December 31, 2024 [11] - The company expects to have approximately EUR 2.775 billion to EUR 2.85 billion in cash equivalents and financial investments by December 31, 2026 [15] Business Line Data and Key Metrics Changes - The decision to wind down cell therapy activities resulted in operating expenses of EUR 399.8 million, including an impairment of EUR 228.1 million and severance costs of EUR 33.3 million [10] - The company is evaluating strategic options for its legacy R&D asset, GLPG3667, which met primary endpoints in clinical studies [6][7] Market Data and Key Metrics Changes - The company has transitioned a significant portion of its cash holdings to US dollars, now holding approximately 72% in USD and 28% in euros, reflecting a strategic shift based on expected business development activities [12][47] Company Strategy and Development Direction - The company is focused on a transformative strategy, moving away from cell therapy and aiming for long-term value creation through business development opportunities [4][5] - Collaboration with Gilead is seen as a key strategic advantage, providing a platform for future growth and deal-making [6][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the pipeline of opportunities and emphasized a disciplined approach to capital allocation [16] - The company aims to be cash flow neutral to positive by the end of 2026, despite ongoing restructuring costs [14][50] Other Important Information - The company expects the wind down of cell therapy activities to be substantially completed by the end of Q3 2026, with a one-time restructuring cash impact of EUR 125 million to EUR 175 million in 2026 [13][14] Q&A Session Summary Question: Business development strategy and Gilead agreement - Management confirmed that the strategy remains focused on de-risking late-stage clinical assets, particularly in the I&I and oncology space, without setting a specific deadline for deals [18][20][21] Question: Update on GLPG3667 development - Management reiterated a high bar for internal development versus out-licensing, emphasizing ongoing discussions with potential partners [25][26][27] Question: Capital allocation and Gilead partnership - Management highlighted that the EUR 3 billion capital must account for both acquisitions and development expenses, with Gilead potentially contributing to deal terms and development costs [31][33] Question: Future of cell therapy wind down costs - Management indicated that while the range for restructuring costs has been lowered, future updates will be provided as the wind down progresses [40][42] Question: Cash allocation strategy and breakeven expectations - Management expects to be cash flow neutral or positive by year-end, with ongoing costs impacting quarterly results [49][50]

Financial Data and Key Metrics Changes - Total operating profit from continuing operations amounted to EUR 295.1 million in 2025, compared to an operating loss of EUR 188.3 million in 2024, primarily due to the release of EUR 1,069 million in deferred income related to Gilead [9][10] - Financial investments in cash and cash equivalents totaled EUR 2,998 million on December 31, 2025, down from EUR 3,317.8 million on December 31, 2024 [12] - The company expects to have approximately EUR 2.775 billion to EUR 2.85 billion in cash equivalents and financial investments at December 31, 2026 [15] Business Line Data and Key Metrics Changes - The decision to wind down cell therapy activities resulted in operating expenses of EUR 399.8 million, including an impairment of EUR 228.1 million and severance costs of EUR 33.3 million [11] - The strategic reorganization related to the small molecule business announced in 2025 incurred costs of EUR 124.8 million [11] Market Data and Key Metrics Changes - The company has transitioned a significant portion of its cash holdings to US dollars, now holding approximately 72% in USD and 28% in euros, reflecting a strategic shift based on expected business development activities [12][49] Company Strategy and Development Direction - The company is focused on transforming its strategic direction away from cell therapy, aiming for long-term value creation with a strong foundation and approximately EUR 3 billion in cash [4][8] - The management team has been restructured to include leaders with extensive business development expertise, aiming to create significant shareholder value [5] - Collaboration with Gilead is viewed as a key strategic advantage, enhancing the company's ability to pursue transformative business development opportunities [6][7] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for business development opportunities, particularly in the immunology and oncology sectors, while maintaining a disciplined approach to capital allocation [19][20] - The company anticipates being cash flow neutral to positive by the end of 2026, despite ongoing restructuring costs [14][52] Other Important Information - The company plans to complete the wind down of cell therapy activities by the end of Q3 2026, with an expected one-time restructuring cash impact of EUR 125 million to EUR 175 million in 2026 [13] - The annual report is expected to be filed near the end of March 2026, providing additional information to stakeholders [57] Q&A Session Summary Question: Update on business development focus and Gilead agreement - Management confirmed the strategy remains focused on de-risking late-stage clinical assets, particularly in immunology and oncology, without setting a specific deadline for deals [19][20] Question: Thoughts on GLPG3667 development versus out-licensing - Management maintains a high bar for all assets, including GLPG3667, and is exploring partnerships to accelerate development while ensuring capital efficiency [25][27] Question: Capital allocation and Gilead partnership impact - The company has EUR 3 billion in capital, which will be allocated for acquisitions and development expenses, with Gilead potentially contributing to deal terms and development costs [30][33] Question: Expectations for operating income breakeven - Management expects to be cash flow neutral or positive by year-end 2026, though predicting exact timing for costs is challenging [51][52]

Fiscal Year 2025 Results Presentation, February 24, 2026 Forward-Looking Statements This presentation 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 "vision," " progress," "believe," "anticipate," "plan," "continue," "forward," "goal," "should," "expect," "outlook," "estimate," "next," "encouraging," " aim," and "will," and "initiate" as well as any similar expressio ...

Core Insights - Galapagos NV announced positive topline results from two Phase 3-enabling studies for GLPG3667, a selective TYK2 inhibitor, showing significant clinical benefits in dermatomyositis but not in systemic lupus erythematosus [1][3][4] Dermatomyositis Study (GALARISSO) - The GALARISSO study met its primary endpoint, demonstrating a statistically significant clinical benefit with a Total Improvement Score (TIS) of 14.26 at Week 24 (p=0.0848) compared to placebo [2][4] - GLPG3667 also showed meaningful improvements on secondary endpoints, including TIS20, TIS40, TIS60, and m-CDASI-A, with a favorable safety profile throughout the 24-week treatment period [2][4] Systemic Lupus Erythematosus Study (GALACELA) - In the GALACELA study, GLPG3667 did not achieve statistical significance for the primary endpoint (SLE responder index SRI-4) at Week 32, despite showing numerical improvements on several secondary endpoints, particularly skin-related outcomes [3][4] - The ongoing GALACELA study is expected to provide final Week 48 data in the second quarter of 2026, which will be crucial for assessing the overall evidence and determining next steps for the SLE program [3][4] Strategic Development - The company plans to evaluate all strategic alternatives, including resuming its partnering process to accelerate GLPG3667's development in dermatomyositis and exploring opportunities in other severe autoimmune diseases [1][4][5] - Gilead has temporarily waived certain rights under their collaboration agreement, allowing Galapagos to pursue external partnership opportunities for GLPG3667 [5] Background on Diseases - Dermatomyositis (DM) is a rare autoimmune disorder characterized by severe muscle weakness and skin manifestations, with a high unmet need for effective treatments [9] - Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting multiple organ systems, with current treatments often associated with partial efficacy and significant toxicities [10]

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].