MorphoSys AG (NASDAQ:MOR) Q3 2023 Earnings Call Transcript

I would, for example, quote the anemia data which, as you know, are very impressive in our Phase 2 and we anticipate that in our Phase 3, we will also have a very good score on that one, and this is very important to put in the package. So, we will be ready to file swiftly with the totality of the data and the rich set of data we are preparing, we already have and we’ll have with the Phase 3, both on the efficacy and the safety side. Now on the reimbursement aspect, well, it’s all based on the data. It’s a value-based approach. With what we know from the Phase 2 already, we know that we have — we’re building value here for the patients and that’s what is recognized by the payers. We will be leveraging that in our discussions later on with the payers in the U.S. and ex-U.S. And we believe that with incremental — significantly incremental value brought by the product for the patients on many aspects we’ve been discussing several times, we can sustain a strong reimbursement and pricing commensurate of the innovation we’re bringing here.

Jason Butler: Great. Thank you. We’re excited to see the data.

Jean-Paul Kress: We are too. Thanks.

Operator: The next question comes from the line of James Gordon with JP Morgan. Please go ahead.

James Gordon: Hello. James Gordon, JP Morgan. Thanks for taking the questions. Firstly, in the release last night, you suggested you saw the potential to meaningfully improve upon current first-line treatments. Can you just confirm that there is confidence in a statistic benefit on both the SVR35 primary and TSS50 secondary? Second question was, looking at the scheduling for the MANIFEST-2 data ASH. Can you — had the organizer seen any element of the study result, or were they totally blinded? And had you hoped for a more prominent session versus the Sunday session, like a presidential session or anything like that? And then third and final, just on funding. Assuming MANIFEST-2 does deliver, and hopefully it does, how are you thinking about the next funding steps for the company? So, would you partner in some geographies or you’d raise equity? What would you do to fund some of the things you were laying out in the presentation?

Tim Demuth: Hey, James. This is Tim again. So, the study has the primary endpoint of spleen volume reduction, and as secondary endpoints, we’re looking at the improvement in symptomatology and of course, they are connected to AP value. On the question of the ASH manuscript, as you see — or the ASH abstract rather, we submitted the abstract as it appeared just very recently, so without data, which is highly unusual for ASH, as you know, to accept a data-free abstract, and for that, we are very pleased to have gotten an oral presentation and what counts for us is the opportunity to be able to share this data in an oral format with the scientific community. And again, we are very pleased to have gotten that opportunity from ASH.

Jean-Paul Kress: On the partnering and financing question, James. So, the great thing with pelabresib and this is why we were so keen on acquiring Constellation at the time, 2021, is that it’s not tied to any previous partnership that the company actually was thinking doing. So, we have the whole slate. That being said, after the data, we will think about what kind of deployment we want. We are ready in the U.S. The intention is to commercialize ourselves in the U.S. We have an experienced Monjuvi organization with a very strong overlap with the myelofibrosis treatment. So, this is very important, very different situation than when we launched Monjuvi four years ago. So, we’ll see. But you can always imagine that non-dilutive possibilities for partnering ex-U.S., or these kind of thing. So, more to come on that. It will be a great problem to have when we have the data. Then the financing, I’ll pass on to Lucy.

Lucinda Crabtree: Yes. Hi, James. Yes, of course, the priority is to ensure we continue to retain a strong balance sheet in the future. That in turn, obviously is important to make sure we continue to deliver value. And as you might expect, we’ll continue to weigh up all appropriate funding options available to us and we’ll update as and when it’s — as and when we can.

Operator: [Operator Instructions] The next question comes from the line of Philippa Pritchard with Morgan Stanley. Please go ahead.

Philippa Pritchard: Hi, there. Thank you for taking my questions. Just a couple from me, please. So, firstly, on the MANIFEST-2 endpoints, you mentioned that there are other endpoints such as absolute TSS, PFS, et cetera., that would be important to look at alongside TSS50 and SVR35. And I know that it’s been mentioned before that the totality, breadth, and depth of data are important to look at and consider, amongst other things. But the impression so far has been that a statistic TSS50 benefit needs to be seen for approval. So, could you please expand on and remind us how flexible you believe regulatory authorities may be in the event that TSS50 may not be statistic? Secondly, just a question related to Slide number 7, where you mention that 13% of U.S. physicians were hesitant to utilize pela.