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| Statement |
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| We have very high confidence in a positive MANIFEST-2 trial outcome for the following reasons |
| So we just have to be patient because it’s a PFS driven study and I mean we think we will have a strong data and it’ll be a very good propeller for Monjuvi |
| We delivered and surpassed expectations on our key priorities, and we will continue to build on this great momentum as we enter an exciting second half of the year |
| We shared the very exciting and very strong proof-of-concept data in essential thrombocythemia for these patients |
| So I think that's a very strong and comfortable basis for us to develop further steps |
| These preliminary results are very promising and showcase the therapies best-in-class potential in an array of cancer types |
| As Jean-Paul mentioned, and I will just emphasize that again, and I said it in my prepared remarks already our Phase 2 study showed very strong results on spleen volume response and TSS50 AbbVie shows very clearly that Phase 2 results are very well replicated in Phase 3 |
| Well, we continue to be very excited and impressed by the performance of our partners |
| So Phase 3 plus size of the opportunity is very promising |
| So basically we strongly believe in our assets and we think we have the best out there |
| So based on that and are strong Phase 2 results, we think we'll have a very strong outcome with our Phase 3 trial and we're very confident in that |
| So as we saw recently, Phase 2 first line myelofibrosis trials results are strong proxy for Phase 3 trials |
| As such, based on our strong Phase 2 results, we are very optimistic about the performance of the pelabresib and ruxolitinib combination in our pivotal trials |
| I'll come back to my first comments for the first question in the call, I mean the fact that we have both the power, which is way above or bigger than the power from AbbVie and the fact that our Phase 2 trial showed great results on both endpoints is very – it's very strong and make us very confident in the outcome |
| If we are 35% or 68% and TSS50 of 56%, and our safety results were actually very good |
| And what we had with the Roche data or an approval a couple of months ago is very encouraging for us because we have made the right choices in terms of clinical trial design for this frontMIND study |
| Beyond the currently approved indication, we see the largest potential upside for Monjuvi in the first-line DLBCL setting, which we are investigating in our Phase 3 frontMIND study |
| We have a strong U.S |
| In our Phase 2 trial, remember, we've shown a strong efficacy, our data was very strong on both end points |
| We’ve made exceptional progress with our pipeline |
| So we are very well powered and much more power than they are |
| These patients also experience commonly symptoms, which are measured in the total symptom score improvement here in our ARM-4 data from MANIFEST shows very encouraging data |
| Look, we think it is out – this outcome is actually extremely positive from MorphoSys |
| It is supporting the business to deliver what we believe is an incredibly exciting future product for myelofibrosis |
| We are very optimistic about the potential for pelabresib to improve the standard of care as a foundational first line treatment |
| We saw strong efficacy and safety results in the Phase 2 MANIFEST trial data that were presented most recently at the 2023 EHA Annual Meeting in June |
| We have over delivered on our key priorities and are excited to build on this great momentum in the second half of the year |
| For DLBCL, we are – we continue to educate on our strong long-term data and most recently the five years data in R DLBCL, very good traction with it |
| The first half of 2023 has been marked by exceptional progress at MorphoSys |
| Our solid cash position enables us to not only reach the pivotal data milestone for the Phase 3 study of pelabresib, but to also provide a cash runway of at least 12 months beyond the pivotal data readout |
| Statement |
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| But as you mentioned, there is increasing competition |
| So the pilot is very difficult to draw |
| The year-over-year decline was driven by streamlining and focusing of selling efforts |
| For the second quarter of 2023, we reported a consolidated net loss of €74 million compared to a net loss of €235 million in the second quarter of 2022 |
| This has not been observed with ruxolitinib monotherapy as treatment of this therapy has been shown to cause a drop in hemoglobin levels |
| And for many, that relief fades with time |
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