Galapagos N.V. Q1 FY2025 earnings call

Executive Leadership Changes - Henry Gosebruch appointed Founding CEO of SpinCo, with deep experience in M&A, business development, etc. - Paul Stoffels to retire as CEO within 12 months, to serve as Non-Executive Chair post-successor appointment. ### Clinical Pipeline - Dosed first U.S. patient in ATALANTA-1 study of GLPG5101; completed indolent NHL cohort enrollment, added DLBCL Richter transformation cohort; selected MCL as lead indication for pivotal trial, aiming for pivotal start in 2026 and approval in 2028. - Progressed earlier stage discovery programs, expect to initiate clinical development of novel CAR-T candidate and select at least one program for IND-enabling studies in 2025. ### Decentralized Manufacturing - Expanding DMU network in U.S. and Europe; collaborations with Lonza, Thermo Fisher, Catalent, etc., to ensure clinical and commercial supply. ### SpinCo Details - Henry Gosebruch as Founding CEO; SpinCo to focus on transformational transactions in oncology, immunology, virology; Galapagos to focus on cell therapy pipeline via decentralized manufacturing.

Total net revenues for the first quarter of 2025 were EUR 75 million, including EUR 14 million of supply revenues related to Jyseleca and EUR 61 million in collaboration revenues. Operating expenses increased due to clinical expansion in oncology CAR-T, DMU network build-out, and restructuring costs. Cash balance at the end of Q1 2025 was EUR 3.3 billion. Upon separation, SpinCo will have approximately EUR 2.45 billion, and Galapagos will have ~EUR 500 million in cash with a cash runway to 2028. Galapagos' normalized annual cash burn is expected to be between EUR 175 million and EUR 225 million excluding restructuring costs.

2025 Catalysts - Top-line data from indolent NHL cohort in second half of 2025; MCL cohort data in second half of 2025. - End-of Phase 2 meeting for MCL to align pivotal trial design. - Dose first patients with armed CAR-T candidate in 2025; select next-gen candidate for IND-enabling studies by year-end. - Announce SpinCo management/board appointments and obtain shareholder approval for separation by mid-year. ### Cash Runway - Galapagos expects cash runway to fund operations to 2028 post-separation.

• Regulatory uncertainties: Potential delays or changes in regulatory requirements for manufacturing and clinical trials. - Execution risks: Challenges in executing SpinCo separation, including hiring and setting up SpinCo's leadership team. - Clinical trial risks: Variability in patient response, site performance, and potential issues with pivotal trial design and enrollment.

Q: Brian Abrahams from RBC Capital Markets asked about MCL registrational requirements and cash runway.

A: Paul Stoffels and Omotayo Fasan discussed MCL's high unmet need and pivotal trial design; Thad Huston addressed cash runway aligning with 2028.

Q: Phil Nadeau from TD Cowan inquired about manufacturing requirements and DMU numbers.

A: Paul Stoffels said regulatory requirements are well-defined; Thad Huston mentioned evolving DMU network towards regional hubs.

Q: Sebastiaan van der Schoot from Van Lanschot Kempen asked about partnerships and next-gen assets.

A: Paul Stoffels and John Mellors talked about potential partnerships on the DMU platform and next-gen assets targeting high unmet needs in liquid and solid tumors.

Q: Manos Mastorakis from Deutsche Bank asked about M&A strategy and SpinCo independence.

A: Thad Huston said SpinCo will be independent; Paul Stoffels mentioned activity ongoing to prepare for potential deals.

Q: Faisal Khurshid from Leerink Partners asked about MCL data update and follow-up.

A: Omotayo Fasan provided details on MCL patient enrollment and follow-up; Paul Stoffels spoke about indication selection and program progress.

Q: Judah Frommer from Morgan Stanley asked about collaboration expansion and SpinCo focus.

A: Paul Stoffels and Omotayo Fasan discussed interest in the platform and SpinCo's focus on oncology, immunology, virology; ongoing partnerships for DMUs.

Q: Chi Fong from Bank of America asked about BCMA therapy mitigation strategies.

A: Omotayo Fasan and Paul Stoffels discussed mitigation strategies in the AMENDA Phase I protocol and progress on the BCMA study.

Q: Unidentified Analyst from Raymond James asked about U.S. clinical trial variability and ATLANTA-1 cohort.

A: Omotayo Fasan addressed patient variability and cohort progress; Paul Stoffels spoke about cohort enrollment and progression.

Q: David Seynnaeve from DegroofPetercam asked about PAPILIO-1 patient enrollment and top-line results.

A: Paul Stoffels responded on ongoing enrollment and expected 2026 reporting of top-line data.