MorphoSys AG

Ladies and gentlemen, good afternoon and good morning. My name is Julia Nagybauer, Head of Industrial Relations at Morphosis, and it is my pleasure to welcome you to our first quarter 2023 Financial Results Conference call. Joining me on the call today are Jean-Paul Kretz, Chief Executive Officer, Tim DeMuth, Chief Research and Development Officer, and Joe Hovert, U.S. General Manager, who will join for the Q&A. 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 risks and uncertainties that may cause our actual results to differ materially, including those described in Morphosis 20-F, an annual report, all for the year ended December 31, 2022, and from time to time in other SEC documents of Morphosis. It is important to keep in mind that our statements in this webcast speak as of today. On slide three, you will find the agenda for today's call. Jean-Paul will begin with an overview of the outlook. After that, Tim will share an update on our clinical development work, and then we will provide a summary of our first quarter 2023 financial results. Following our prepared remarks, we will open the call for your questions. With that, I now hand the call over to Jean-Paul.

Good morning and good afternoon, everyone. Thanks for joining us today. We had a strong first quarter marked by numerous achievements. We are more focused than ever on the opportunities ahead of us this year, and I'm confident that we will deliver. Collaborative, our investigational best inhibitor, is a potential best and first in class foundational first-line treatment for patients with myelofibrosis. It represents our largest and most immediate opportunity. This quarter, we announced that we completed enrollment of our Phase III Manifest-II study of Pelabrasib in myelofibrosis ahead of schedule. As a result, The top line data from the trial are now expected by the end of 2023, months earlier than previously anticipated. This advancement of the trial timeline also provides us with the opportunity to bring collaborative to patients much earlier. The Manifest-2 study enrolling ahead of schedule underscores that there is a significant need for better treatment options for patients with myelofibrosis. Further, it shows the enthusiasm of investigators in treating physicians for telabrasive. In speaking with physicians who treat myelofibrosis patients, we constantly hear that depth and durability of responses to treatment are limited with current first-line therapy. Results from our phase two manifest study of Pelabrasib in myelofibrosis suggest that Pelabrasib in combination with a JAK inhibitor may offer prolonged improvement in both spleen size and symptom severity at and beyond 24 weeks. Further to this, in the manifest study, Changes in biomarkers correlated with improvements in clinical measures of treatment success, suggesting a potential disease-modifying effect of Pelabrasib. The body of data presented on Pelabrasib to date reiterates its potential to address the critical needs of myelofibrosis patients. We are later focused on delivering the top-line data from the Phase III Manifest-II study by the end of this year. We also see great potential for collaboration beyond myelofibrosis, and we will continue to explore it in treating patients with other myeloid diseases. Monjuvi continues to address critical needs of patients living with relapsed olfactory diffuse large B-cell lymphoma, also known as DLBCL. In the first quarter, Monjuvinate cells were 20.8 million US dollars, representing an 11% year-over-year growth, and on track with our 2023 guidance. At the 2023 AACR Annual Meeting, we presented final five-year follow-up data from the Phase II L-MIND study. These data show that Monjuvi plus lenalidomide offers prolonged and durable responses in adults with relapse of a factory DLDCL with 40% of patients who received the regimen still alive after five years. The durable responses and consistent safety profile observed in the five-year analysis further support the Monjuvi regimen as a potential curative option for appropriate patients. We believe the largest opportunity for Monjuvi is in the first-line DLBCL setting. Last month, we announced that enrollment of the phase three FranceMind study is also complete, with more than 880 patients enrolled in the trial. The study is exploring tacathetamide plus lenalidomide in addition to ARCHOP, the current standard of care for this patient population, versus ARCHOP alone, are the first-line treatment for patients with high intermediate and high-risk BLBCL. We look forward to sharing data from the trial in the second half of 2025. We have a rich set of pivotal catalysts over the next two years, starting with the collaborative phase three data in first-line myelofibrosis later this year. To ensure we are set up for success, we continue to take steps to optimize our cost structure and further strengthen our financial position. For example, we recently purchased parts of our convertible bonds that are due in 2025 to reduce our debt. We did this to take advantage of the market dynamics as the bond is trading with a significant discount. As a result, we were able to buy back approximately 19% of our outstanding principal amount at a lower cost. We continue to concentrate our investments on our most advanced clinical programs that we create near-term value. I would now like to turn the call over to Tim to provide the development update. Tim, over to you.

Thank you, Jean-Paul. We continue to advance our ongoing mid- to late-stage clinical programs and make exceptional progress. We'll start with Pelabrasib. The phase three Manifest-2 study is our number one priority. Manifest-2 is a global multicenter, double-blind study of more than 400 patients who were naive to JAK inhibitors. Patients were randomized one-to-one to Pelabrasib in combination with Ruxolitinib or placebo plus Ruxolitinib. The primary endpoint of the study is the proportion of patients who achieve a 35% or greater reduction in spleen volume at week 24, known as SVR35. The key secondary endpoint is the proportion of patients achieving a 50% or greater improvement in total symptom score at week 24. This is known as TSS50 and is measured by the myelofibrosis symptom assessment form version 4.0. The MANIFEST-II study is supported by findings from the Phase II MANIFEST trial of Pelabrasib in combination with Raxolitinib in patients with myelofibrosis, including those who were JAK inhibitor-naive. Updated results from MANIFEST were presented at the ASH meeting in December 2022 and were recently published in the Journal of Clinical Oncology. These results suggest that Palabrasib in combination with Ruxolitinib provides prolonged improvement in both spleen size and symptom severity at and beyond 24 weeks. In the manifest study, changes in biomarkers correlated with improvements in clinical measures of treatment success. This included SVR35, TSS50, and hemoglobin increases indicative of improved anemia, suggesting a disease-modifying effect of Pelabrasib. Examined biomarkers included bone marrow scarring, known as fibrosis, and the frequency of the JAK2 allele that is known to drive disease activity. All patients who had clinical responses plus reduced allele frequency and improvement in bone marrow fibrosis were naive to JAK inhibitors. Based on the body of data we have presented thus far, our confidence in Pellabrasib and the Phase III Manifest-II study is high. And we look forward to releasing the top-line data from the trial data this year. Moving on to Tofacitimab. As Shofar mentioned, at the 2023 AACR annual meeting, final data from our Phase II L-MIND study were presented during a late-breaking oral presentation, spotlighting five-year efficacy and safety results in patients with relapsed or refractory DLBCL. At the data cutoff, the overall response rate of patients enrolled in the study was 58%. And complete response was observed in 41% of patients. The median overall survival was 34 months with 40% of patients alive at five years. The regimen was well tolerated and no new safety signals were identified. The prolonged and durable responses seen at five years among patients in this study are very meaningful. and show that the Monjuvi treatment regimen has curative potential. Beyond the currently approved indication, we're also exploring tefacitamab in two phase three studies, front-mind in first-line DLBCL and in-mind in relapsed or refractory follicular or marginal zone lymphoma, which is being driven by our partner Insight. For about 50% of patients with high intermediate and high risk DLBCL, the standard of care first-line therapy, RCHOP, is ineffective. And the prognosis for patients with relapsed or refractory disease is very poor. We are investigating the potential of adding tefacitamab and lenalidomide to RCHOP to increase the DLBCL cure rate in the first line. and help more patients avoid relapse. At the ASCO 2023 Annual Meeting in early June, we will present data that reinforces the strong potential of our pipeline. Our presentations feature proof-of-concept data on pellabrasib in essential thrombocytemia and tolimetastat, our investigational next-generation dual inhibitor of ECH2 and ECH1 in a broad array of advanced tumors. In our Phase II manifest study, Palabrasib is also being investigated in patients with essential thrombocytemia, in addition to myelofibrosis. These indications are both myeloproliferative neoplasms. which are types of blood cancers that begin with a genetic change in bone marrow stem cells. One arm of the manifest study is exploring pellabrasib as monotherapy in patients with high-risk essential thrombocytemia who are refractory or intolerant to hydroxyurea, the chemotherapeutic agents most used to treat this disease. Proof-of-concept data from this arm of the Phase II study will be presented during a poster discussion session. Totonib metastat is being evaluated in a Phase I-II trial in patients with advanced solid tumors or lymphomas, including ARID1A-mutated ovarian carcinoma and endometrial carcinoma, VAP1-mutated mesothelioma, and peripheral T-cell lymphoma. Tolumetastat was designed to improve on first-generation ECH2 inhibitors through increased potency, longer residence time on target, and a longer half-life, offering the potential for enhanced anti-tumor activity. Preliminary results from the phase two portion of the study evaluating Tolumetastat across multiple tumor types will be presented during a poster session. In summary, the data we are presenting at ASCO 2023 showcase the wealth of potential opportunities that our pipeline offers to address the critical needs of people living with blood cancers, including myeloid malignancies, and those patients with solid tumors. With that, I now turn the call over to Julia to review our financials.