MorphoSys AG

Ladies and gentlemen, good afternoon and good morning. My name is Julia Neugebauer, Senior Director Investor Relations at Northosis, and it is my pleasure to welcome you to our fourth quarter and full year 2021 Financial Results Conference Call. Joining me on the call today are Jean-Paul Kress, Chief Executive Officer, Sung Lee, Chief Financial Officer, Malte Peters, Chief Research and Development Officer, and Joe Horvath, US General Manager, who will be available for the Q&A session. 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 20F, an annual report, all for the year ended December 31st, 2021, and from time to time in other SEC documents of morphosis. It is important to keep in mind that our statements on 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 and will give an outlook. I will provide an update on our development pipeline before turning the call to Sam for a summary on our fourth quarter and full year 2021 financial results. Following these prepared remarks, we will open the call for your questions. With that, I'll hand now the call over to Jean-Paul.

Thank you, Julia. Welcome, everyone, and thank you for joining us today. At Morphosis, our ambition is to be a leader in hematology oncology. with two commercial products by 2025. 2021 was a transformational year for us. It was marked by our first full year of the Montjuic launch in the U.S., and approvals and launches outside of the U.S. with our partner Insight. We also took a bold step with the acquisition of Constellation Pharmaceuticals, which expanded our clinical pipeline in hematology oncology. Our clinical pipeline has never been as robust as it is today. We currently have three pivotal studies enrolling, one for Pelabrasib in first-line myelofibrosis, which we believe has the potential to change the standard of care for patients with myelofibrosis, and two for Monjuvi with one in first-line DLDCL and a second in relapsed refractory follicular lymphoma and marginal zone lymphoma. We are also progressing to phase two programs with CPI-0209 and Felsartamab. In 2022, the major focus of us will be on rapidly enrolling our pivotal studies. Turning to our commercial results on slide six. Montjuvi fourth quarter net sales were 23.6 million and 79.1 million for the full year. The fourth quarter grew 39% year over year and 7% sequentially. The first quarter growth was driven primarily by demand. And roughly 70% of orders from sites of care come from the community setting and the balance from the academic setting. Since launch and through the end of 2021, approximately 2,000 patients have been treated with Monjuvi. We view this as significant considering the relatively short time Monjuvi has been available in the U.S. Close to 1,000 sites of care have ordered Monjuvi since launch through the end of 2021, which is an increase from Q3 where we stood at 850. In the fourth quarter, more than 70% of our orders from sites of care were repeat orders which is indicative of the regular use of Monjuvi at those sites of care. We continue to have the leading market share of second-line new patient starts, and we are very pleased that Monjuvi was recently designated as a preferred regimen by the NCCN guidelines for the second-line treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma. This will further facilitate the use of Monjuvi in earlier line patients as doctors receive clear guidance on the treatment sequence in this disease. We continue our efforts to educate healthcare providers on the optimal duration of therapy and the benefits of keeping patients on our immunotherapy treatment longer. The traditional behavior for physicians in the RRDL-BCL setting has been to treat for a few months. This is consistent with what we see with Monjuvi. While the actual time on treatment with Monjuvi is as long or even slightly longer than other available options, it's definitely not where the optimal regimen should be with an immunotherapy. Given the profile of the Monjuvi lenalidomide combination and the recent NCCN guideline, We are working to change this treatment behavior and to increase persistency over time. Moving to slide seven, beyond the currently approved indication, we see the biggest opportunity for Montjuvi in first-line DLBCL. Our pivotal front-mine trial is enrolling very well with significant interest from the medical community. Recently published data from competitor trials have validated our approach to focus on high-risk patients with an IPI of 3 to 5. Another significant opportunity is Pelabrasib, which we added to our portfolio through the acquisition of Constellation Pharma last year. We believe that Pelabrasib has the potential to change the standard of care for patients with myelofibrosis. There remains a large unmet need for these patients, and this indication alone represents a significant commercial opportunity. We are especially excited about the opportunity in first-line myelofibrosis, where Pelabrasib is currently being studied in a pivotal study called Manifest-2, and the enrollment of this trial is progressing very well. We recently announced exciting data at the ASH annual meeting where the ARM3 of the Manifest Phase 2 trial confirmed earlier data cut-offs and increased our confidence for the Pivotal trial and its probability of success. As we look to Catalyst for 2022, we are excited that Roche is planning to announce data from the two Pivotal graduate studies with Gantanerumab in Alzheimer's disease in the fourth quarter of this year. Roche also just initiated an additional phase three study with Gantanerumab for the prevention of Alzheimer's, which is indicative of their confidence in this monoclonal antibody. We also expect GSK to share pivotal data for Otilimab in rheumatoid arthritis. And for both programs, we retain a substantial share of the royalties. Now for our own mid-stage programs, the EZ-H2 inhibitor, CPI-0209, and Felsartamab in autoimmune diseases, we are expecting proof-of-concept data this year. In addition, from a financial standpoint, we have a strong balance sheet that takes us through collaborative pivotal data in 2024. We continue to stay focused on and invest in our largest potential value creating opportunities and remain disciplined with our capital deployment. With that, I will now turn the call over to Malte for an R&D update. Malte, please.

Thank you, Jean-Paul. As Jean-Paul mentioned, 2021 was a transformational year for Morphosis. We significantly expanded our pipeline, supporting our ambition to become a leader in hematology and oncology. Let's start with Pelabrasib, our BET inhibitor. Pelabrasib is currently being developed as a potential treatment for myelofibrosis. Myelofibrosis is a bone marrow cancer for which only limited treatment options are available, affecting approximately 35,000 people in the United States and in Europe. The current standard of care for myelofibrosis is ruxolitinib, a JAK inhibitor, but only 50% of patients are being adequately treated. Based on recently published data, we believe that pilabrasib has the potential to change the standard of care in the treatment of myelofibrosis, and we are receiving very positive feedback from key opinion leaders. We have two ongoing clinical trials. The manifest phase two study is evaluating pilabrasib in different settings. The key setting is arm three, in which we are exploring pilabrasib in combination with ruxolitinib as first-line treatment for patients with myelofibrosis. In December 2021 at ASH, we presented the latest data from the manifest study, both for the primary endpoint SVR35, which refers to a 35% spleen volume reduction at week 24, as well as the secondary endpoint, TSS50, referring to a 50% reduction of total symptom score at week 24. The results demonstrated an SVR35 score in 68% of patients and a TSS50 score in 56%. which is numerically significantly higher to what was observed in ruxolitinib single-agent clinical trials. Additionally, analysis from an exploratory endpoint presented at ASH21 showed a reduction of megakaryocyte clustering in bone marrow and a correlation with spleen volume reduction. Megakaryocytes are the cells in the bone marrow responsible for making platelets. and the clustering of these cells are one of the signs of myelofibrosis. This data suggests that pilabrasib may have a potential in changing the course of myelofibrosis. In summary, these latest data reaffirm our confidence in our second study, which is called MANIFEST-2, and is our ongoing phase 3 study that is comparing the combination of ruxolitinib plus pilabrasib versus ruxolitinib alone as first-line treatment for myelofibrosis. Let me provide some more details about this study. We have achieved a turnaround in the operational excellence for the execution of this study. Our measures, such as the addition of additional CROs, improvement of the interaction with investigators, and the expansion of the number of countries and study sites start to pay off. With all activities in place, enrollment is progressing well, and we expect to report top-line data from Manifest 2 in the first half of 2024. Now moving to TAFA CETAMAS. We are also making progress with the clinical development of tafacetamol. We have two pivotal phase three studies ongoing, expanding the potential of this medicine into patients with first-line DLBCL and patients with relapsed refractory indolent lymphoma. The first-line DLBCL setting represents an area of significant unmet medical need. Our pivotal phase three study, FrontMind, is on track and enrolling at a good pace with significant interest from the medical community. Investigators are excited about this study, and we have added 40 additional sites in the United States to satisfy investigator and patient interest. Recently released data from competitor trials have reinforced the potential to enhance the current standard of care and increased the confidence in our trial design that focuses on high-risk patients with an IPI score of 3 to 5. We also see great interest in the InMind study, our ongoing pivotal study in relapsed refractory follicular lymphoma and marginal zone lymphoma, which is conducted by our partner Insight. Shortly, we will also treat the first patients in our Mindway trial, a study that is investigating an optimized treatment schedule with a reduced number of administrations for patients with non-Hodgkin lymphoma. Optimizing the treatment schedule is particularly important for patients with follicular lymphoma and relapsed refractory DLBCL. In 2022, we expect several data readouts from our mid-stage assets, CPI-2029 and Felzatamab. We are encouraged by the progress of our CPI-0209 clinical trial and by the preliminary data we are observing. And we plan to report data at a medical conference in the second half of this year. This EZH2 inhibitor, which we believe has best-in-class potential, is currently being assessed in a basket trial for several solid tumors as well as lymphoma. Felsatamab, our anti-CD38 antibody, is being evaluated in two kidney autoimmune indications, namely autoimmune membranous nephropathy and IgA nephropathy, for which there are limited treatment options available. In 2021, we presented early proof-of-concept data demonstrating that fisatamab can rapidly and significantly reduce anti-PLA2R antibody titers in difficult-to-treat patients with anti-PLA2R antibody-positive membranous nephropathy. Our two ongoing trials, Mplace and NuPlace, are fully enrolled. and we expect to share more mature data, including data on proteinuria, from this trial in the second half of this year. Also, our phase two trial in IgA nephropathy called IGNATS is progressing well, and we will share data later this year. As you can see on slide 13, we expect to deliver a steady flow of clinical data over the next several years, which we believe have the potential to change the treatment paradigms of several types of cancers and autoimmune diseases. We are very excited about our progress and the potential of our pipeline. With that, I now turn the call over to Thang for a review of the financials.