Galapagos has suffered a significant setback as it decided not to submit a Marketing Authorization Application (MAA) for its drug Jyseleca (filgotinib) in Crohn’s disease, based on disappointing results from a Phase III study. Additionally, Galapagos will not proceed with the MAA for filgotinib in ulcerative colitis (UC) in Switzerland. These decisions are a major blow to the company, which had high hopes for Jyseleca’s potential in these lucrative indications.
The impact on Galapagos is reflected in its revised sales guidance for Jyseleca in 2023, reducing it from 140-160 million euros to 100-120 million euros. Despite this setback, Galapagos does have a favorable balance sheet with 3.9 billion euros on hand for business development.
Since CEO Paul Stoffels, previously from Johnson & Johnson, took over in March last year, quickly acquired two CAR-T companies CellPoint and AboundBio for a combined $251 million. The timeline for these potential moves is set for the next 18 months.
“The market and competitive landscape for the JAK class in Europe has changed significantly over the past six months. We are in the process of evaluating strategic options for Jyseleca. There’s a tremendous opportunity for us to really drive an innovative approach to bringing life-saving therapies to patients. We’re doing some things that the other players are not doing that is really exciting.”
– Thad Huston, Galapagos CFO and CCO
Once a biotech powerhouse with a $5 billion partnership with Gilead in 2019, Galapagos has experienced a decline in its value. After reaching a peak share price of $268 in early 2020, the value has plummeted to $41.75. The decline began when the FDA rejected filgotinib in rheumatoid arthritis due to toxicity issues.
Last year, Galapagos executed a pipeline trim and downsized by 200 roles as part of the strategy to focus on immunology and oncology, emphasizing “best-in-disease validated targets in our strategic therapeutic areas with shorter time-to-patient potential.” Despite these challenges, Galapagos aims to regain momentum through strategic acquisitions and partnerships in the coming months.
