Galapagos N.V. Q4 FY2024 earnings call

• 2024 was productive with progress in GLPG5101 CD19 CAR-T clinical development, including FDA IND clearance and ATALANTA study results. - Key partnerships in cell therapy: with Lonza, Thermo Fisher, Excellos, and Adaptimmune. - Transferred Jyseleca business to Alfasigma, saving ~EUR 200 million. - Plan to separate into two entities: Galapagos focusing on cell therapy and SpinCo building a pipeline with Gilead. - Decentralized manufacturing platform for cell therapy, aiming for seven-day vein-to-vein time. - Prioritizing GLPG5101 in CD19 CAR-T portfolio, deprioritizing GLPG5201, advancing GLPG5301 in multiple myeloma, and early-stage next-gen cell therapies. - Completing SLE and DM Phase II studies for TYK2 inhibitor GLPG3667, expecting top-line results in H1 2026.

Total revenues for full year 2024 were €276 million, including €35 million of supply revenues related to Jyseleca and €241 million in collaboration revenues. Research and development expenses were €335 million (a 39% increase year-over-year, driven by oncology CAR-T expansion). G&A and sales and marketing expenses were flat at €134 million. Net profit for the year was €74 million, driven by fair value adjustments, currency exchange, interest income, and the gain from discontinuing the Jyseleca business.

• Plan to separate into Galapagos and SpinCo, with Galapagos focusing on cell therapy and SpinCo building a pipeline with Gilead. - Galapagos has ~€500 million cash post-separation, providing runway until 2028 with normalized cash burn ~€175 million to €225 million. - Aim to start pivotal studies for GLPG5101 in 2026, first approval in 2028. - Initiate clinical development of novel CAR-T candidate in 2025. - Progress early-stage next-gen cell therapy pipeline including uza-cel. - Complete Phase III enabling studies for TYK2 inhibitor in SLE and DM while seeking partnerships.

Q: Regarding GLPG5101 and GLPG5201, what's the difference and why deprioritize GLPG5201?

A: Paul Stoffels explained that running two CD19 CAR-Ts in parallel is cumbersome for decentralized manufacturing. Focusing on GLPG5101 allows simplifying DMU network, accelerating into CLL and Richter transformation with FDA clearance for Richter. Vectors differ but fresh cells drive efficacy.

Q: Differences in manufacturing process/characteristics between GLPG5101 and GLPG5201? And what's rate limiting in separation?

A: Jeevan Shetty said manufacturing fundamentals same (fresh cells, seven-day vein-to-vein), vectors different. Thad Huston said separation involves hiring management, legal steps, and shareholder approval at midyear.

Q: Update on 5201 IND filing and confidence 5101 will look similar in CLL? And SpinCo asset types?

A: Paulus Stoffels said 5101 and 5201 have similar efficacy/safety, main reason is DMU network simplification. Thad Huston said SpinCo will focus on innovative medicines in virology, immunology, oncology with transformational transactions.

Q: Pivotal development for 5101, indication/trial strategy, and US manufacturing footprint?

A: Jeevan Shetty said will expand into Burkitt's, primary CNS lymphoma, high-risk DLBCL. Thad Huston said decentralized manufacturing with Landmark Bio in Boston, looking to expand regional sites.

Q: Interest from external partners for decentralized manufacturing units?

A: Paul Stoffels said have inbound questions, partnering on platform and co-development, examples with Adaptimmune.

Q: 2028 cash runway guidance, milestones?

A: Thad Huston said ~€175 million to €225 million burn rate, milestones include pivotal in 2026, 5301 readout, next-gen platforms into clinic.

Q: ATALANTA study first patient dosing in US?

A: Jeevan Shetty said patient recruitment ongoing, working towards first patient soon.

Q: Decentralized vs centralized manufacturing regulator differences, and uza-cel deal terms?

A: Paul Stoffels said follow high regulatory standards, similar to central manufacturing. Paul Stoffels said uza-cel deal is ~$100 million option, initial indication head and neck cancer, option to expand to other indications.