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GLPG

Galapagos NV

Galapagos NV Q1 FY2024 earnings call

May 3, 2024 · fiscal period ended 2024-03

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Summary

Generated 2024-05-03

Management highlights

• Paul discussed the company's vision to transform patient outcomes through science and innovation, the company transformation including transfer of Jyseleca business to Alfasigma, new management team with experienced leaders, and platform technologies in small molecules, cell therapy, and biologics. • Thad provided financial results noting continued operations revenue was flat year-over-year, R&D costs increased due to oncology investments, net profit from discontinued operations from Jyseleca transaction, and reaffirmed full-year cash burn guidance of EUR 280 million to EUR 320 million. • Discussed pipeline progress in oncology (CAR-T programs) and immunology (Phase II studies), decentralized CAR-T manufacturing platform, and early-stage pipeline progress with over 15 discovery programs.

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Segment performance

No detailed product segment financial performance with absolute terms and revenue contribution % provided in the transcript.

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Guidance

• Operational cash burn for Q1 2024 was EUR 125 million, with expectation of improvement in future quarters and reaffirmed full-year cash burn guidance of EUR 280 million to EUR 320 million. • Anticipate regulatory progress with CAR-T trials in US, plan to submit IND for NHL trial mid-year, submit additional IND for CLL and Richter's transformation in second half, and expand trials in various areas. • Aim to add additional sites for decentralized CAR-T manufacturing network globally and explore additional partnerships and licensing agreements.

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Q&A highlights

Q: As you mentioned, the tech transfer is due in H1 this year. Do you think this is the gating factor for rapid progression of enrollment for the trial? And once centers are set up, can we expect rapid enrollment increase and quick progression to pivotal dose expansion phase?

A: Jeevan Shetty and Thad Huston responded discussing tech transfer going hand-in-hand with IND filings for NHL and CLL, and focus on expanding sites in US and Europe to support clinical studies.

Q: In terms of 5101, 5201 and 5301, when could we see the next data?

A: Jeevan Shetty stated data from 5101 and 5201 will be presented at upcoming hematology conferences this year, and 5301 program just started recruitment so data will come later.

Q: How are you thinking about advancing 5301 in multiple myeloma, especially with competitor products? And how much additional value does decentralized manufacturing offer to multiple myeloma vs NHL or CLL?

A: Paulus Stoffels discussed 5301 in Phase I, learning from 5101 and 5201 data on fresh cells, and decentralized manufacturing's benefits in scalability and access for patients.

Q: Thoughts on other CAR-T players' moves and if it confirms need for point of care CAR-T and if it invites competition?

A: Paulus Stoffels and Jeevan Shetty responded on Cocoon system's scalability, differentiation from others by delivering fresh product, and benefits in addressing unmet medical need.

Q: Talk about R&D efforts for CAR-T in broader I&I outside of lupus and on 3667 exploring additional indications?

A: Paulus Stoffels discussed ongoing R&D in CAR-T for I&I, focusing on proof of concept in lupus and dermatomyositis first, and thoughts on exploring 3667 in additional indications after validating current ones.

Q: On business development approach, preference for licensing vs M&A?

A: Thad Huston stated both licensing and M&A are on the table, with assessment of various BD opportunities to complement internal research programs.

Q: View on targeted oncology and degraders in portfolio?

A: Paulus Stoffels discussed collaboration with BridGene and strategic investment in Frontier, focusing on addressing unmet medical needs with precision medicine.

Q: Vision on CLL program progress and likelihood of pivotal study after update, and comparison to BMS' approval?

A: Jeevan Shetty talked about CLL program expansion, regulatory discussions, and comparison to BMS data highlighting differences in their study and Galapagos' unique platform benefits.

Q: Expect yield as string of pearls or outright acquisition of one company with late assets?

A: Thad Huston stated both string of pearls and assessment of larger BD opportunities are being considered, with evaluation of various potential deals.

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Transcript

May 3, 2024

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