Galapagos Q3 2024 Financial Results and Business Update

Galapagos NV has made significant strides in its cell therapy and small molecule pipeline, aimed at addressing high unmet medical needs. The company has over 20 ongoing programs, with four assets in clinical development across 11 indications, and more than 15 preclinical programs focusing on oncology and immunology. One notable achievement is the FDA clearance of the Investigational New Drug (IND) application for the Phase 1/2 ATALANTA-1 study of their CD19 CAR-T candidate, GLPG5101, for relapsed/refractory non-Hodgkin lymphoma (R/R NHL). This marks a significant advancement in their cell therapy endeavors, utilizing an innovative decentralized manufacturing platform. In addition, recruitment has resumed for the Phase 1/2 PAPILIO-1 study involving their BCMA CAR-T candidate, GLPG5301, targeting relapsed/refractory multiple myeloma (R/R MM).

In collaboration with Blood Centers of America (BCA), Galapagos has chosen Excellos in the San Diego area as the first decentralized manufacturing unit to produce GLPG5101 for the ATALANTA-1 study sites in the region. The company is also progressing with early-stage proprietary pipeline projects, advancing next-generation armed, bispecific CAR-T candidates in hemato-oncology and promising small molecule candidates in immunology into IND-enabling studies, aiming for clinical development between 2025 and 2026.

Financially, Galapagos has maintained a robust position with €3.3 billion in cash and financial investments as of September 30, 2024. The company has reconfirmed its full-year 2024 cash burn guidance of €370 million to €410 million. For the first nine months of 2024, Galapagos reported total net revenues of €200.1 million, an increase from €179.8 million in the same period of 2023. Despite this revenue growth, the company experienced an operating loss of €125.6 million, compared to a loss of €41.9 million the previous year. The increased R&D expenses, rising from €167.2 million to €238.2 million, primarily drove this loss, reflecting the higher costs associated with advancing their cell therapy and small molecule programs in oncology.

General and administrative (G&A) and sales and marketing (S&M) expenses also saw a rise, totaling €93.2 million for the first nine months of 2024, up from €87.4 million in the same period of 2023. This increase was attributed to higher legal and professional fees associated with business development activities and investments in strategic marketing for oncology. These increases were partially offset by a decrease in G&A personnel expenses due to lower costs for subscription rights plans.

Galapagos continues to expand its decentralized manufacturing unit (DMU) network in Europe and the U.S. to support the clinical development and commercial readiness of its cell therapy candidates. The company is also actively exploring strategic partnerships, early-stage research collaborations, licensing, and acquisitions to accelerate its pipeline in oncology and immunology.

On the corporate front, the Board of Directors appointed Mr. Oleg Nodelman as Non-Executive Non-Independent Director, replacing Dr. Dan Baker, effective October 7, 2024. This change aims to strengthen the company's leadership and strategic direction.

For the first nine months of 2024, Galapagos reported a net profit of €48.8 million, a decrease from €54.1 million in the same period of 2023. The company has outlined its plans for future growth, emphasizing the acceleration of its early-stage pipeline with the goal of launching at least four IND/CTA-enabling studies in 2025 across different modalities and indications. From 2026 onwards, Galapagos aims to introduce at least two new clinical assets annually, spanning various indications across its cell therapy and small molecule portfolio.

Overall, Galapagos remains committed to transforming patient outcomes through innovative science and strategic investments, with a strong financial foundation to support its ambitious pipeline and growth objectives.