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MorphoSys AG
3/14/2024
Ladies and gentlemen, good afternoon and good morning. Expectations for compounds in our pipeline, as well as the development plans of our collaboration partners, and statements about the proposed acquisition of morphoses by Novartis. 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 Form 20F and Annual Report, all for the year ended December 31st, 2023, 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. This is the agenda for today's call. Jean-Paul will begin with an overview of 2023 and an outlook for 2024. Tim will then share an update on our clinical development work with a focus on PayLab Recip and Lucy will follow this with a summary of our financial results. After our prepared remarks, we will open the call for your questions. I now hand the call over to Jean-Paul.
Good morning and good afternoon, everyone. Thanks for joining us today. 2023 was a critical and exciting year for Morphosis. We over-delivered on our key priorities, advanced our potential best and first-in-class oncology pipeline, and further strengthened our financial position, resulting in the company entering into a business combination agreement on February 5, 2024, to be acquired by Novartis. Pelabrasib, our investigational beta inhibitor, is at the forefront of our promising pipeline. In 2023, we demonstrated the potential for Pelabrasib to shift the myelofibrosis treatment paradigm as results from our Phase III, Manifest II study showed that all four disease hallmarks were improved with Pelabrasib and ruxolitinib combination therapy over standard of care at 24 weeks. Patients with myelofibrosis urgently need new options to treat this disease, and pursuing approval of Pelabrasib in first-line myelofibrosis remains our top priority. We also see great opportunity to expand Pelabrasib into other myeloid disease indications beyond myelofibrosis. We are very pleased with the progress of Tulmimetostat, our investigational next-generation dual inhibitor of EZH2 and EZH1, which has shown deep responses in heavily pretreated patients across a broad array of advanced solid tumors and lymphomas in a phase two study. We are continuing investigations of this promising agent and look forward to further elucidating its therapeutic potential. Because of this exceptional progress, we recently announced Novartis offer to acquire Morphosis. After a thorough review of all strategic options, we firmly believe that this decision is in the best interest of Morphosis, our shareholders, and cancer patients. Novartis offer provides attractive, immediate, and certain cash value to Morphosis shareholders. Novartis intends to offer Morphosis shareholders 68 euros per share in cash for a total equity value of 2.7 billion euros. The offer price corresponds to a premium of 94% and 142% on the volume weighted average price during the last two and three months as of the unaffected January 25, 2024 close, respectively. Additionally, Novartis' ample resources, additional scientific expertise, and global footprint can help accelerate Pellab Recipes' potential worldwide. Until the proposed transaction closes, Morphosis and Novartis are acting as two separate companies. As such, Morphosis has very clear priorities for the first half of this year. First, we are focused on closing the Novartis acquisition, which we expect will occur in the first half of 2024. The closing process is progressing steadily and we do not expect any issues. We received antitrust clearances in Germany and Austria and have also made antitrust filings in the U.S. under the HSR Act. The next step in the takeover process is for Novartis to publish their offer document, which is expected next month. Both companies are fully committed to making the acquisition a reality. Next, we are continuing to prepare regulatory filings for the Pelabrasib and Ruxolitinib combination in first-line myelofibrosis with the intention of submitting applications to the US FDA and the European Medicines Agency in the middle of 2024. We are also working to complete transfer of Tafacitamab to Insight, our longstanding collaborator, following the announcement of its sale on February 5th, 2024. Lastly, we are diligently managing our cash runway and maintaining business continuity during this exciting infection point for our company. I would now like to turn the call over to Tim, who will provide a development update. Tim, please.
Thank you, Jean-Paul. Good morning and good afternoon, everyone. Since our phase three, manifest two results were presented at the ASH annual meeting in December 2023. The myelofibrosis physician community has consistently stated that the Pelabrasib and Ruxolitinib combination has the potential to shift the treatment paradigm of this debilitating and deadly disease. Notably, in the MANIFEST-2 study, Pelabrasib and Ruxolitinib nearly doubled the proportion of patients achieving at least a 35% reduction in spleen volume over placebo plus Ruxolitinib at 24 weeks, meeting the primary endpoint of the study. This was a meaningful result given the known association between spleen volume reduction and patient survival. Additionally, compared with placebo plus Raxolitinib, the combination of Pelabrasib and Raxolitinib showed a strong positive trend in reducing symptom burden and improvements across measures of anemia and bone marrow fibrosis at 24 weeks. Very importantly, the Pelabrasib and Raxolitinib combination demonstrated safety results in line with assessments from prior clinical trials. Further, Pelabrasib and Raxolitinib was associated with fewer grade three or higher adverse events compared with placebo plus Raxolitinib. These findings point to the potential for Pelabrasib and Raxolitinib to become the new standard of care for patients with myelofibrosis. With these strong results in hand, our key objective is to bring Pelabrasib to patients as quickly as possible. This is why our number one priority is preparing and filing our regulatory submissions in the US and Europe by the middle of 2024. We are on track for this process and are confident that our comprehensive, collaborative data package will provide impactful evidence to the respective regulatory agencies. We are also continuing to prioritize scientific communications and medical education work for collaborative across the US and Europe to our experienced medical affairs team. We continue to collect safety and efficacy data, including duration of treatment data from the Manifest 2 Phase 3 study. Durability of response is key for physicians treating myelofibrosis, especially as the benefits of currently approved therapies tend to fade over time. We have seen deep and durable responses in patients with myelofibrosis, the dipalabrasib and raxolitinib combination, at and beyond 60 weeks in the Phase II Manifest Study. We plan to share new data for Manifest II at a scientific congress in the first half of this year. I would now like to turn the call over to Lucy for an update on our financials.
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