MorphoSys AG

Ladies and gentlemen, good afternoon or good morning. My name is Julia Neubauer, Head of Investor Relations at Mophosis, and it is my pleasure to welcome you to our third quarter 2023 financial and results conference call. With me on the call today are Jean-Paul Kress, our Chief Executive Officer, Tim DeMuth, our Chief Research and Development Officer, and Lucy Crabtree, our Chief Financial Officer. Before we begin, I'd like to remind you on slide two that some of the statements made during the call today are forward-looking statements, including statements regarding our expectations for the commercialization of our products and our development plans, and expectations for the compounds in our pipeline, as well as the development plans of our collaboration partners. These forward-looking statements are subject to a number of risk certainties that may cause our actual results to differ materially, including those described in Morphosis 20F and annual report, all for the year ended December 31st, 2022, and from time to time in other SEC documents of morphosis. It is important to keep in mind that our statement in this webcast speak as of today. On slide three, you find the agenda for today's call. Jean-Paul will begin with an overview and give an outlook. After that, Tim will share an update on our clinical development work, and then Lucy will provide a summary of our third quarter 2023 financial results. Following our prepared remarks, we will open the call for your questions. With that, I hand the call over to Jean-Paul.

Thank you, Julia. Good morning and good afternoon, everyone. Thanks for joining us today. We are very excited that the top-line results from our Phase III Manifest-II study of Pelabrasib in combination with Rixolitinib in first-line myelofibrosis will be available by the end of November. Shortly after, We will present detailed findings from the study at the 2023 ASH annual meeting during an oral presentation on Sunday, December 10th. Pelabrasib, our investigational best inhibitor, has the potential to meaningfully improve upon the current standard of care for myelofibrosis. Right now, we believe we have the best new molecule to treat this disease. Our phase two manifest study showed the strong efficacy and safety profile of Pelabrasib in myelofibrosis, with deep and durable improvements in spleen volume and symptom reduction at 24, 48, and 60 weeks. Further to this, in the manifest study, changes in biomarkers correlated with improvements in certain clinical measures of treatment success, suggesting a potential disease-modifying effect of Pelabrasid. These Phase II data underscore the strength of this combination therapy, and we remain very confident in the outcome of the Manifest-II study. Combination treatment is the highly anticipated next step to address the inadequate splint size reduction, symptom control, and lack of response durability observed with JAK inhibitors in myelofibrosis, the current standard of care. Our market research shows that the majority of US community and academic-based physicians view combination therapy as the way of the future in myelofibrosis. The Pelabrasib and Ruxolitinib combination therapy was ranked among the highest in top product attributes driving treatment decisions against Ruxolitinib, Momelotinib, and the Navitoclax and Ruxolitinib combination. These physicians commented on Pelabrasib's impressive efficacy and were pleased that the combination was well-tolerated and appeared to have a benefit for anemia. This reaffirms the excitement we continue to hear from physicians around Pelabrasib, reflecting the dire need for more effective and well-tolerated therapies to treat myelofibrosis. Moving to Monjuvi. Monjuvi, our CD19-targeting immunotherapy, continues to be prescribed to certain adult patients with relaxed or refractory DLBCL. In the third quarter, Monjuvi net sales were 23.4 million US dollars. This represents a 5% year-over-year growth and is on track with our 2023 guidance, allowing us to narrow our full-year 2023 guidance target. Beyond its currently approved indication, the largest potential upside for Montjuvi is in the first-line DLBCL setting, which we are investigating in our Phase III false-mine study. Data from that trial which randomized nearly 900 patients, are projected for the second half of 2025. Monjuvi is also being explored in the phase three in-mind study in relapsed refractory follicular lymphoma and marginal zone lymphoma, which is being run by our partner Insight. These data will be available in 2024. The strong U.S. commercial infrastructure we have in place for Monjuvie would also enable the smooth launch of Pelabracine, as we have encountered a large overlap in treating physicians for DLD-CL and myelofibrosis, especially in the community setting.

Beyond our pivotal programs, we are pleased with the progress of Tulmimetostat,