Galapagos NV

Good day and thank you for standing by. Welcome to the Galapagos Q3 2023 financial results conference call. At this time all participants are in a listen-only mode. After the speaker's presentation there will be a question and answer session. To ask a question during the session you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question please press star 1 1 again. Please, the advice at today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sophie Van Heysel. Please go ahead.

Thank you, Operator, and welcome all to the audio webcast of Galapagos' Q3 2023 results. I'm Sophie Van Heysel, 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. I 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, Calabco's actual results may differ materially from the results expressed or implied in these statements. Today's speakers will be Dr. Paul Stoffels, CEO and Chairman, SADS Houston, CFO and COO, and Dr. Jeevan Shetty, head clinical development oncology. Paul will give an introduction and provide a strategic overview. Thad will then go over the operational and financial results, and Jeevan will discuss our CAR-T programs. You will see a presentation on screen. We estimate that the prepared remarks will take about 25 minutes. Then we'll open it up to Q&A with Paul, Thad, and Jeevan, joined by Michele Manto, chief commercial officer, and Dr. Daniele D'Ambrosio, head of immunology. And with that, I'll now turn it over to Paul.

Thank you, Sophie, and thank you all for joining today. I would like to start by taking a moment to remind you of our vision and mission to bring transformational medicines to patients around the world. This drives everything we do at Galapagos. Over the past year, we have taken key strategic steps First, with the implementation of a new operating model and a new approach to research and development to accelerate innovation and strengthen our pipeline. And now, with the intended changes related to our Jaisalica business. We reached a critical moment, and we have chosen what we believe is the best option for patients, our people, and Jaisalica. Now, let me walk through the key terms of the deal announced on Monday. Galapagos intends to transfer the entire Icelica business to Alpha Sigma, including the European and UK marketing authorization, sales, marketing, and all forgotten development activities, as well as approximately 400 employees across our European operations. Alpha Sigma is a profitable, privately owned pharmaceutical company in Italy, ranking among the top five with revenues over 1.2 billion euros in 2022. In the contemplated transaction, Galapagos will receive €50 million upfront and is entitled to sales-based milestones of up to €120 million. In addition, Alpha Sigma will pay royalties in the mid-single to mid-double digits to Galapagos. Galapagos will pay up to €40 million in development costs to Alpha Sigma before June 2025. We also announced that we plan to adjust our remaining workforce and streamline our operations to align with renewed focus on innovation. This is expected to impact approximately 100 positions. This will allow us to focus on innovation and accelerate our pipeline of best-in-class transformational medicines in our core areas of immunology and oncology. The completion of the intended transaction is subject to the execution of a definitive agreement and customary conditions, including regulatory approvals and consultations with work councils. With the signing of the letter of intent to transfer Jaiselica business to Alpha Sigma, we completed our process of exploring strategic options for Jaiselica as announced at the half-year earnings call in August. So, let's have a look at the pipeline focused on immunology and oncology. For our immunology franchise, the isellica is grayed out, given by the plant transfer. We are progressing our TIK2 in dermatomyositis and EZ-LE. And we aim to start a patient study with a CD19 CAR-T candidate, 5101, in severe refractory lupus early next year. Meanwhile, we are working on multiple exciting preclinical targets that we are eager to push forward if we see a best-in-class potential. In oncology, we made good progress with the CD19 CAR-T programs and plan to start the BCMA CAR-T program in multiple myeloma in the coming weeks. Together with our research team, we are working on next-gen CAR-Ts as we are evaluating BD opportunities in this space too. Today's earning calls we will focus on important progress that we are making with our oncology programs. We are very pleased that we'll have the opportunity to present three posters at ASH in December. The data in the abstract, released yesterday, underline that our CAR T programs, manufactured at point of care, are delivering on their promise. In today's presentation, we will discuss the encouraging data in CLL and NHL observed with our product candidates, 5201 and 5101, as well as the clinical study design of 5301, our third CAR-T program manufactured at Point of Care. Importantly, we initiated the tech transfer following the agreement with the Boston-based Landmark Bio. This is a key milestone in the geographical expansion of our unique Point of Care production technology and the start of clinical development of our CAR-T programs in the US. In parallel, we continue discussions with multiple centers in Europe and the U.S. to further build our point-of-care manufacturing network. In addition, we continue to strengthen our capabilities in oncology with key hires amongst others in regulatory, clinical, PD, and strategic marketing. I would like to take a moment to highlight the strong fundamentals that we put in place over the last 18 months. We renewed our discovery portfolio and are working hard on accelerating our early-stage pipeline. We continue to broaden our late-stage pipeline, pushing forward our internal programs and scouting for business development opportunities. We are making important progress with our CAR-T programs and are actively expanding our point-of-care footprint with our Cocoon platform. With the transfer of Kaiselica, we can further streamline our organization. And to support our innovation, we aim to approximately at 100 expert roles over the course of next year. And we commit to stay disciplined in our use of cash to focus our investments and to maximize value. Summarizing, we have been executing on our company transformation and now have a fleet path outlined for value creation. Now I hand it over to Tad, who will provide an operational and financial update.