Core Viewpoint - Galapagos NV has entered into a strategic collaboration with Blood Centers of America (BCA) to decentralize the manufacturing of its CAR-T cell therapies, enhancing access and efficiency in the U.S. market [1][4]. Group 1: Collaboration Details - The collaboration allows Galapagos to utilize BCA's network of over 50 community blood centers across 43 states for Good Manufacturing Practice compliant manufacturing [1][7]. - BCA will facilitate technology transfer to multiple sites, enabling decentralized manufacturing close to cancer treatment centers and providing apheresis capacity when needed [2][7]. - This partnership is expected to accelerate site initiation and onboarding, ensuring consistent quality in the manufacturing process [2][4]. Group 2: Manufacturing Platform Advantages - Galapagos' decentralized CAR-T manufacturing platform aims to overcome current limitations in CAR-T production, offering faster and scalable solutions [3][5]. - The platform promises a median vein-to-vein time of seven days for the delivery of fresh, fit cells, enhancing physician control and improving patient experience [3][5]. - The manufacturing process includes an end-to-end xCellit™ workflow management system and a proprietary quality control strategy [5]. Group 3: Strategic Importance - This collaboration marks a significant milestone in Galapagos' U.S. expansion strategy, supporting pivotal studies and potential future commercial manufacturing of CAR-T therapies [4][7]. - The partnership complements existing collaborations with Landmark Bio and Thermo Fisher Scientific, enhancing Galapagos' operational capabilities [4][7]. - BCA's extensive experience in regulatory compliant biologic processing is expected to facilitate seamless technology transfer across multiple sites [4][9].

Financial Data and Key Metrics Changes - The company reported an operational cash burn of EUR 125 million for Q1 2024, which is on the higher end due to the phased transition of services for the Jyseleca business to Alfasigma [20] - The cash balance as of March 31, 2024, amounted to EUR 3.6 billion, indicating a strong financial position to support R&D and collaboration opportunities [16][37] - A net profit was recorded driven by fair value adjustments, foreign exchange, and EUR 25 million in interest income, along with a net profit from discontinued operations of EUR 67 million mainly from the Jyseleca transaction [98] Business Line Data and Key Metrics Changes - The company is progressing its Phase I/II CAR-T programs, specifically 5101 in NHL and 5201 in CLL and Richter's transformation, with ongoing clinical trials showing encouraging efficacy and safety results [10][11] - Revenue remained flat year-over-year, primarily consisting of the linear recognition of the platform for the Gilead collaboration, while R&D costs increased due to investments in oncology [36] Market Data and Key Metrics Changes - The company is expanding its decentralized CAR-T manufacturing network in both the U.S. and Europe, collaborating with Landmark Bio and Thermo Fisher to enhance capacity [35] - The company aims to submit IND applications for its NHL trial and CLL and Richter's transformation trials in the U.S. in mid and second half of 2024, respectively [99] Company Strategy and Development Direction - The company focuses on driving value creation in immunology and oncology, addressing significant unmet medical needs through a revitalized pipeline and strong leadership [8][15] - The strategy includes a decentralized manufacturing model for CAR-T therapies, allowing for greater physician oversight and scalability [18][94] - The company is actively pursuing business development opportunities, including licensing and acquisitions, to broaden its portfolio and enhance its R&D capabilities [53][54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory path forward for the CLL program and the potential to significantly contribute to patient care [2][3] - The company anticipates important regulatory progress with its CAR-T trials in the U.S. and aims to confirm safety, efficacy, and durability data in upcoming hematology conferences [21][76] - Management highlighted the high unmet medical need in the market and the opportunity to improve patient outcomes with their innovative therapies [85][92] Other Important Information - The company has over 15 discovery programs across oncology and immunology, with plans to deliver the first preclinical candidates this year and start first-in-human studies in 2025 [96] - The management team has extensive experience, having brought over 30 drugs to market, which supports the company's capabilities in driving value creation [9] Q&A Session Summary Question: Is the tech transfer a gating factor for rapid enrollment in trials? - Management confirmed that the tech transfer is crucial for patient recruitment and is aligned with ongoing clinical programs in Europe, with plans to accelerate in the U.S. [26][57] Question: When can we expect the next data from programs 5101, 5201, and 5301? - Management indicated that data will be presented in upcoming hematology conferences, with continuous enrollment and updates expected throughout 2024 [29][76] Question: How does the decentralized manufacturing process add value to multiple myeloma treatment? - Management noted that fresh cells provide significant efficacy and safety, and the decentralized model allows for closer proximity to patients, potentially improving outcomes [45][47] Question: What is the company's approach to business development opportunities? - Management stated that both licensing and M&A are on the table, focusing on high unmet medical needs and opportunities to add substantial value [53][67] Question: How does the company view competition in the CAR-T space? - Management believes their Cocoon system offers scalability and addresses high unmet medical needs, differentiating them from competitors [60][62]

Financial Performance - Group net revenues for Q1 2024 amounted to €100 million, reflecting a 7% increase from €58.6 million in Q1 2023[5] - Net profit from continuing operations for Q1 2024 was €23.5 million, compared to a net loss of €11.2 million in Q1 2023[12] - Total net revenues for Q1 2024 reached €62,432 thousand, an increase of 6.3% compared to €58,574 thousand in Q1 2023[26] - Net profit for Q1 2024 was €90,220 thousand, significantly higher than €23,207 thousand in Q1 2023, marking a year-over-year increase of 287.5%[26] - Total comprehensive income attributable to owners of the parent for Q1 2024 was €94,468 thousand, compared to €23,148 thousand in Q1 2023[27] Research and Development - R&D expenses increased by 36% to €71.6 million in Q1 2024, up from €52.5 million in Q1 2023, primarily due to higher costs for CAR-T and small molecule programs[7] - Research and development expenses rose to €71,614 thousand in Q1 2024, up 36.3% from €52,559 thousand in Q1 2023[26] - The company plans to file Investigational New Drug applications in the U.S. for its CAR-T programs in hemato-oncology[22] - The company is expanding its decentralized CAR-T network in the U.S. and Europe, aiming to enhance its clinical programs[3] - The company has a decentralized CAR-T manufacturing network aimed at enhancing its capabilities in oncology and immunology[23] Cash and Financial Position - Cash and current financial investments totaled €3.6 billion as of March 31, 2024, down from €4.0 billion at the end of 2023[15] - The company reaffirmed its cash burn guidance for 2024 at €280 million to €320 million, a decrease from €414.8 million in 2023[16] - Cash and cash equivalents decreased to €73,372 thousand from €166,803 thousand at the end of 2023, reflecting a decrease of 56.0%[28] - The operational cash burn for the first three months of 2024 amounted to €125.2 million[34] - The decrease in cash and cash equivalents for the same period was €93.9 million[34] Discontinued Operations - The transfer of the Jyseleca® business to Alfasigma was completed on January 31, 2024, impacting revenue recognition and operational costs[8] - Total operating profit from discontinued operations was €66.7 million in Q1 2024, compared to €36.1 million in the same period last year[13] Equity and Assets - Total assets as of March 31, 2024, were €4,361,379 thousand, slightly up from €4,357,396 thousand at the end of 2023[28] - As of March 31, 2024, total equity stood at €2,895.01 million[32] - On March 31, 2023, total equity was €2,564.60 million, indicating growth in equity over the year[32] Strategic Collaborations - Strategic collaborations were established with BridGene Biosciences and Thermo Fisher Scientific to strengthen the oncology pipeline and CAR-T manufacturing capabilities[6] Other Financial Metrics - Basic and diluted earnings per share for Q1 2024 were €1.37, compared to €0.35 in Q1 2023[26] - The company reported an operating loss of €33,131 thousand for Q1 2024, compared to a loss of €14,198 thousand in Q1 2023[26] - The company reported a share-based compensation of €4.97 million for the first quarter of 2024[34] - The company had a net sale of current financial investments amounting to €69.5 million during the first quarter of 2024[34] - Cash-out related to the sale of subsidiaries was €1.3 million[34] - The acquisition of financial assets held at fair value through profit or loss amounted to €36.9 million[34]

Mechelen, Belgium; 30 April 2024, 22:01 CET; Galapagos NV ((Euronext &amp, NASDAQ:GLPG) today announces that all resolutions proposed at the company's Annual and Extraordinary Shareholders' Meetings (AGM and EGM) held on 30 April 2024 were approved. The AGM approved, amongst other items: The Remuneration Report and revised Remuneration PolicyThe remuneration of the members of the Board of DirectorsThe reappointment of Dr. Elisabeth Svanberg as Independent Non-Executive Director The appointments of Dr. Susan ...

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 &amp, 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 th ...

Galapagos NV (GLPG) has been beaten down lately with too much selling pressure. While the stock has lost 7.9% over the past four weeks, there is light at the end of the tunnel as it is now in oversold territory and Wall Street analysts expect the company to report better earnings than they predicted earlier.How to Determine if a Stock is OversoldWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is oversold. This is a momentum oscillator th ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR If "Other" has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow. ☐ Item 17 ...

EXHIBIT 99.1 Galapagos reports third quarter 2023 results and releases new encouraging data from CAR-T studies for presentation at ASH 2023 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 enc ...

Thad Huston On today's call, Thad will present the operational and financial section. Thad? Galapagos NV (NASDAQ:GLPG) Q2 2023 Results Conference Call August 4, 2023 8:00 AM ET Company Participants Sofie Van Gijsel - Head, IR Paul Stoffels - CEO, Chairman, Interim Head, R&D Thad Huston - CFO and COO Michele Manto - Chief Commercial Officer Daniele D'Ambrosio - Head of Immunology Conference Call Participants I would like to remind everyone that we will be making forward-looking statements during today's webc ...

Galapagos NV (NASDAQ:GLPG) Q1 2023 Earnings Conference Call May 5, 2023 8:00 AM ET Company Participants Sofie Van Gijsel - Head, IR Paulus Stoffels - CEO, Chairman, Interim Head, R&D Bart Filius - President, COO & CFO Michele Manto - Chief Commercial Officer Conference Call Participants Michael Ulz - Morgan Stanley Peter Verdult - Citigroup Dane Leone - Raymond James & Associates Jason Gerberry - Bank of America Merrill Lynch Brian Balchin - Jefferies Operator Good day, and thank you for standing by. Welcom ...