MorphoSys AG

Ladies and gentlemen, good afternoon or good morning. My name is Jula Neugebauer, Senior Director in Best Relations with Nostrosis, and it's my pleasure to welcome you to our third quarter 2021 Financial Results Conference call. Joining me on the call today are Jean-Paul Kress, Chief Executive Officer, Sang Lee, Chief Financial Officer, and Malte Peters, Chief Research and Development Officer. Joe Horvath, U.S. General Manager, 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, impact of COVID-19 on our business, 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 20S, an annual report, all for the year ended December 31st, 2020, and from time to time in other SEC documents, 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 of the third quarter and will give an outlook. Malte will provide an update on our development pipeline before turning the call to Zhang for a summary of our third quarter 2021 financial results. Following these prepared remarks, we will open the call for your questions. With that, I now hand the call over to Jean-Paul.

Thank you, Jan. Welcome everyone and thank you for joining us today. Before I start, I would like to welcome Joe Horvat to this call. Joe is our U.S. General Manager and has been instrumental in leading our commercialization efforts and building momentum since joining the company mid-year. I would also like to thank Roland Vandeler, whom we announced earlier this week will be departing, for his efforts in strengthening the foundation of our commercial operations. Moving to slide five. With the ongoing launch of Monjuvi, important concerning data for Pellabrasib, and the execution of multiple pivotal studies, we are making significant progress on our vision to become a leader in hematology oncology. On slide 6 now. Monjuvi net sales of $22 million for the third quarter increased by 22% compared to the previous quarter. The growth was driven primarily by the map. A greater proportion of second-line patients are now treated with Monjuvi, which over time will increasingly result in a longer duration of therapy. We also saw a broadening of the prescriber base and a high penetration in the community setting. Roughly 70% of orders are coming from the community setting while still maintaining a consistent foothold in the academic setting. Looking more closely at demand, more than 850 accounts have ordered Monjuvi since launch. During the quarter, we received orders from 500 accounts. Over 70% of these accounts were repeat orders, which is an increase from the previous quarter. Enthusiasm for Monjuvi by physicians continues to build. This is supported by our 3-year data from our L-mine trial, which demonstrated a median overall survival of 33.5 months, which means at 4 years, 42% of patients were still alive. Prescriber enthusiasm is also supported by real-world evidence data for the tafacitamab-lenalidomide combination. showing comparable or even longer overall survival compared to other systemic therapies, which we look forward to sharing at ASH. As we approach the end of the first full year on the U.S. market, we are encouraged with the future growth potential of Monjovi as we gain more traction from second-line patients. Importantly, we remain confident that Monjuvi can become a backbone therapy and partner of choice in B-cell malignancies. We are also excited for Monjuvi to expand its geographic footprint and provide broader access for patients. Last quarter, we received conditional approvals in the EU and Canada with our partner Insight, and we are happy to have started to receive the first royalty payments from ex-US markets. Moving to slide 7, we are also making great progress advancing our technical programs. We are very excited about the collaboration which is currently being studied in myelofibrosis in a pivotal study, Manifest 2. If approved, we believe this product has the potential to generate more than $1 billion in sales. We are excited for the upcoming ASH annual meeting, where we will share new data with additional patients from the Manifest Phase 2 trial. The data confirms earlier data cutoffs, and increase our confidence in Pell Abrasive and the probability of success. For Felsartamab, our anti-CD38, we recently announced encouraging early proof-of-concept data in autoimmune membranous nephropathy, and we dosed the first patient in a new Phase II trial for Felsartamab in IgA nephropathy. We believe our next-generation EZ-H2 inhibitor, CPI-0209, has exciting potential and optionality in certain solid and hematologic oncology indications. In summary, we are focused on executing our strategic priorities, and we continue to make significant progress. With that, I will turn the call over to Malte for an R&D update. Malte, please. Thank you, Jean-Paul.

We have made great progress across our pipeline in recent months. Last week, we highlighted our presence at ASH conference in December. We are proud to be able to share data from our two late-stage assets, Monjovi and Pellabrasip, in two oral presentations as well as multiple posters. For Pelabrasib, we will share the latest data from the Manifest Phase 2 trial, including updated data for the primary endpoint spleen volume reduction 35 at week 24 for the combination arm 3 with ruxolitinib in frontline myelofibrosis. Importantly, this data confirms the previous data presented at ASH 2020. giving us further confidence in pilabrasib and specifically in the probability of success for our phase 3 manifest 2 study. We are also excited about some new and previously unpublished data on the disease modification potential of pilabrasib and specifically how pilabrasib differentiates from ruxolitinib. We will present data for the retrospective real world data study Remind 2. Data presented at the SOHO conference earlier this year showed that the tafacetamab and lenalidomide cohort was associated with longer oral survival versus a pooled data set of other systemic therapies, BR and R-GMOX. Our oral presentation at ASH will now show all comparator groups and include Polar-BR, R-square, and CAR-T cell treatments, and we look forward to sharing the data with you. We are excited about Pelabrasip for the treatment of patients with myelofibrosis, and we believe it has first-in-class and best-in-class potential. Pelabrasip impacts the four major hallmarks of myelofibrosis, and we believe it has the potential to become the standard of care. Pelabrasip has shown a strong response rate in combination with ruxinitinib, achieving a spleen volume reduction in 67% of first-line myelofibrosis patients. We intensified our personal interactions with key opinion leaders in the field and received very positive feedback on the data and the compound. We are making great progress to ensure operational excellence for the execution of the ongoing Phase III study, and we are seeing the results of the measures we have implemented. We added additional CROs, improved the interaction with investigators, and expanded the number of countries and sites. With all activities in place, we expect to report top-line data from this study in the first half of 2024. Now moving to Monjuvi. We have two pivotal Phase III studies ongoing, expanding the clinical development to patients with front-line DLBCL and patients with relapsed refractory indolent lymphoma. For FrontMind, we are doing very well in terms of enrollment. Investigators are excited about the study, and we are well underway adding additional sites in the United States to satisfy investigator and patient interest. In late August, Minjuvi, the brand name of Tafacitamab outside of the US, was granted conditional marketing authorization by the European Commission for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for stem cell transplant. Two days earlier, Minjuvi received conditional approval in Canada. In both jurisdictions, our partner Insight is responsible for the commercialization. We are very excited that the European Commission followed the FDA in approving Trafacetamab in combination with Lanalidomide based on compelling data from the Elmine study, supported by our real-world data package. We also made considerable progress with Felzatamab in autoimmune membranous nephropathy, or AMN, a disease with significant unmet medical needs. The M-PLACE study evaluating selzatamab in patients with AMN is fully enrolled and the antibody has shown proof of concept for this indication. The data that we shared at Kidney Week recently demonstrated that selzatamab can rapidly and significantly reduce anti-PLA2R antibody titers in difficult to treat patients with anti-PLA2R positive membranous nephropathy. While it is still early to appreciate the full effect on proteinuria, we are encouraged to see the first patients with a drop in proteinuria already as early as six months after the initiation of treatment. Last month, we also dosed the first patients in the Phase II IGNAL trial in patients with IgA nephropathy, another autoimmune disease affecting the kidney. Dosing of the first patients with IgA nephritis is an exciting milestone for Morphosis physicians and also patients as we are broadening our development program for Fezatomab. We believe Fezatomab could have great potential as a targeted therapy for patients with autoimmune renal diseases with limited treatment options. As you can see, we expect to deliver a steady flow of late-stage clinical data over the next several years, which have the potential to change treatment paradigms in several oncology and autoimmune indications. We are very excited about this progress and the potential of our pipeline. With that, I now turn the call over to Sung for a review of the financials.