Galapagos Q1 2024 Financial Results

Galapagos NV, a biotechnology firm operating in Europe and the U.S., has reported its financial results for the first quarter of 2024 and provided an update on its business activities and outlook for the remainder of the year.

CEO and Chairman Dr. Paul Stoffels highlighted the company's renewed strategic focus and expanding R&D pipeline, emphasizing the goal of bringing innovative treatments to patients globally. He noted significant goals for the year, including progress in clinical programs, achieving regulatory milestones to initiate clinical development of CAR-T programs in the U.S., and expanding a decentralized CAR-T network in the U.S. and Europe. The company continues to develop its early-stage pipeline through internal efforts and external partnerships.

CFO and COO Thad Huston reiterated the commitment to investing in the internal R&D pipeline while actively seeking business development opportunities, particularly in oncology and immunology.

In the first quarter of 2024, key business highlights included:

1. Approval of all proposed resolutions at the Annual and Extraordinary Shareholders’ Meetings held on April 30, 2024.
2. Presentation of decentralized CAR-T manufacturing and a 7-day vein-to-vein approach for hematological cancer care, showcasing promising preliminary data for the CD19 CAR-T candidates GLPG5101 and GLPG5201.
3. Discontinuation of the development of the CD19 CAR-T candidate for refractory systemic lupus erythematosus.
4. Transfer of Jyseleca® business to Alfasigma S.p.A., freeing up resources for growth investments.
5. Signing of a strategic collaboration and license agreement with BridGene Biosciences to bolster the early-stage oncology precision medicine pipeline.
6. Entering a strategic collaboration with Thermo Fisher Scientific for decentralized CAR-T manufacturing in San Francisco.
7. Investment of $40 million in Frontier Medicines' Series C financing round.

Financial performance for the first quarter of 2024:

- Total net revenues increased to €62.4 million from €58.6 million in the same period in 2023.
- R&D expenses rose to €71.6 million, up from €52.5 million due to higher costs associated with CAR-T and small molecule programs.
- General and administrative (G&A) and sales and marketing (S&M) expenses increased to €30.8 million from €27.1 million.
- Net financial income amounted to €56.0 million, significantly higher than €2.8 million in the first quarter of 2023, driven by positive fair value adjustments and net currency exchange gains.
- Net profit from continuing operations was €23.5 million, compared to a net loss of €11.2 million in the first quarter of 2023.
- Cash and current financial investments stood at €3.6 billion as of March 31, 2024.

For the discontinued Jyseleca® business, net profit from operations amounted to €66.7 million, up from €34.4 million in the same period last year. This increase was largely due to the sale of the Jyseleca® business to Alfasigma.

Galapagos reconfirmed its 2024 cash burn guidance of €280 million to €320 million, excluding potential business development opportunities. The company aims to advance three CAR-T Phase 1/2 studies in hemato-oncology and two Phase 2 studies with the TYK2 inhibitor GLPG3667. Additionally, new Investigational New Drug applications for CAR-T programs in hemato-oncology are planned for submission in the U.S.

Galapagos remains focused on evaluating business development opportunities to accelerate and expand its pipeline in oncology and immunology.

A webcast presentation with management is scheduled for May 3, 2024, to discuss these results and outlook in greater detail. The company will also release its half-year results on August 1, 2024, and third-quarter results on October 30, 2024.