Galapagos NV

Good day and thank you for standing by. Welcome to the webcast for the H1 results of Galapagos. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-answer session. To ask a question during the session, you will need to press star and 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star and 0. I would now like to hand the conference over to Sophie. Please go ahead.

Thank you and welcome all to the audio webcast of Galapagos H1 2021 results. I'm Sophie Vangesso, Investor Relations, representing the reporting team at Galapagos. This recorded webcast is accessible via the Galapagos website homepage and will be available for download and replay later on today. We would like to remind everyone that we will be making forward-looking statements during today's webcast. These forward-looking statements include remarks concerning future developments of the pipeline and our company, and possible changes in the industry and competitive environments. Because these forward-looking statements involve risks and uncertainties, Galapagos' actual results may differ materially from the results expressed or implied in these statements. Today's speakers will be Onno van der Stolpen, CEO, Dr. Walid Abisab, CMO, and Bart Filius, COO and President. Ono will reflect on the operational highlights, and Walid will speak to the top line results of our TIC2 and SIK2-3 programs released in July. Then Bart will go over the financial results and end with expected news flow for the year. You will see a presentation on screen. We estimate that the prepared remarks will take about 20 minutes. Then we'll open it up to Q&A with Ono, Walid, and Bart, joined by the rest of our management board. And with that, I'll now turn over to Ono.

Thank you. Thank you, Sophie. Thank you all for joining this webcast in the midst of the summer. I would like to start with the year-to-date in review. If we look at Q1, then clearly we had a big disappointment when our Isabella trial was stopped because of toxic nose and lack of efficacy of our that didn't meet up to expectations in the IPF trial. A big blow for the company, the risk of new mode of actions clearly illustrated here. On the positive side, we had good data on the Menta-Menta-Race study, the testicular tox study that we're doing for Gartinib, where we had an interim analysis after 13 weeks. So that was a positive point. In Q2, Gilead decided to extend the lockup. We had requested that to answer some requests by shareholders, and Gilead actually extended the lockup on the shares that they have in the company up to 2024. So that is a nice certainty regarding the commitment of Gilead for the collaboration and for Galapagos. Forgotten, it was... filed for ulcerative colitis in Japan in the second quarter. For your information, in Europe, that was already filed by the end of 2020, and this was a big step forward for us in Japan. In the third quarter, we had clinical readouts, first from the TIK2 in psoriasis, which was the Phase 1b study, where we saw very nice data. which made us decide to move forward with our TIK2 in a Phase II study, and that will be discussed later on. And we also saw a very promising biological activity of our Toledo program, our SIK2-3 inhibitor, both in psoriasis as well as in ulcerative colitis. Also, that will be extensively discussed by Walid in today's presentation. As a consequence of the setbacks that we have seen with Philgo, the refusal to get it approved in the U.S., as well as the clinical setbacks in 1972 and Zyritaxistat, we decided to do a strategic review and we're implementing that review outcome as we speak. If you look at R&D, we have refocused the pipeline. My next slide will discuss that. In BD, we have said that we are looking for a substantial opportunity to strengthen our pipeline, late stage, and we are in full process at the moment to see if we can find a product or a company that would fit what we are looking for and hope to execute on it when that becomes clear. Commercial, we are rolling out Jaisalica throughout Europe as a consequence of the renegotiations around the Filgotinib deal. We obtained all rights for Jaisalica in Europe. We've taken over a number of employees from Gilead in the process and Jaisalica is now rolled out throughout most of Europe and that will be discussed as well by Bart later in this presentation. And then we also said that we would save on the financials, on the expenses as a consequence of the setback that is now implemented and that will show in the savings going forward in the second half and in the years to come, also to be discussed by Bart. If we look at the pipeline, then clearly it's less mature than we had until the late state failures. but clearly still a very excited and differentiated pipeline focused on inflammation and fibrosis. A third therapeutic area, kidney disease, we have added in the first program in that disease is now in a phase two study. If you look at the pipeline, it's heavily focused on the Toledo program, the SIK2-3, as well as the SIK3 inhibition programs. There are other programs moving forward in discovery towards the clinic. So we hope to see a number of additional molecules reaching the patient in the years to come. We also, as we said earlier, have a very exciting TIK2 program that will go into psoriasis phase 2 as well as in a UC trial phase 2 in 2022. Then I'm not going to discuss the other programs in detail, but clearly we have still a lot of shots at goal here in these disease areas. These are all exciting new mode of action programs that we're moving forward with the risks associated with it, but we believe that we now have a balanced risk profile in our portfolio in diseases where we think we can make the best difference, and we're very excited with what we have now in development. Add to that what we have in research. we have started to rebuild the company after the setbacks in the late stage programs, and we look forward with confidence. With that, I would like to hand it over to Bart Filius, our president. Oh, first we go. We go to Walid.