In light of the COVID-19 outbreak and its unprecedented consequences, we feel that it is important to inform all our stakeholders on where we stand at Galapagos. Fully cognizant of the fact that this is a rapidly evolving situation, with many unknown factors, I want to share the following:
Galapagos has strong measures in place to help prevent spread of the virus and protect the health of our staff. We rolled out our global and site business continuity plans, and took appropriate recommended precautions and restrictions, including suspending all travel. In practice, this means that our employees are working from home, with the exception of the lab personnel and a skeleton IT and facilities team to ensure safety and operational continuity essential to keep research going. For those, we have stringent cleaning and sanitation protocols in place, and we strictly respect social distancing policies at all times, in order to minimize risk of exposure.
- Clinical trials
We have a business continuity plan for our non-clinical and clinical trials, including a pandemic response plan. To date, patient visits in our clinical trials have continued with minimal impact. Of course this is a situation that changes daily, and for which we cannot predict the outcome. However, what we can guarantee you, is that we are continuously monitoring the situation, always putting patients’ safety and needs front & center, and that our teams are working tirelessly with our CROs and clinical trial sites to move trials forward.
- Filgotinib filing process in RA
To date, our collaboration partner, Gilead, has not been informed by the regulatory agencies in the US, Europe and Japan of approval time line delays. Gilead also confirmed that all sites involved in the manufacturing of filgotinib are established sites that currently manufacture other Gilead marketed products, are in good standing with the FDA and are GMP certified.
- Commercial organization
Build-up of our commercial operations in the EU5 countries and the Benelux to prepare for the potential launch of filgotinib continues as planned.
I want to express my thanks – and my pride – for the Galapagos teams. I have seen tremendous flexibility and willpower to move forward, to work hard under difficult circumstances, to be resilient, and to focus on our goal of bringing innovation to patients.
Of course, these are challenging times for us, and our share price has been under severe pressure. At the same time, we are confident. We have a very strong balance sheet, thanks to the Gilead deal closed last year, ending 2019 with cash and current financial investments of €5.8 billion. Moreover, our fundamentals have not changed. We are very proud of our deep, growing pipeline, ranging from early to late stage, and continue to do what we do best: developing molecules with novel modes of action, with the ambition to bring them to patients worldwide.
At Galapagos, we have weathered crises before and came out stronger, every time. We are wired to embrace change, and to see opportunities. I do not know when the dust will settle, but I am convinced that we will make the best of it, together.
To our shareholders, thanks for staying with us throughout these difficult times.
To everyone out there, I sincerely hope that you and your loved ones are staying safe and healthy.
Onno van de Stolpe