Morphosys: Setzen auf marktreife Partnerprojekte und dicke Meilensteine (Seite 463)

[RadarOReilly]

Die 1,6 Milliarden Wette. Glückslos oder der teuerste Strohhalm aller Zeiten!

Pela muss liefern bei dem Preis ansonsten wird es eng.

[tantemartha]

Zur ersten Frage: Verfügen wir über interne Daten? Die Antwort lautet ganz klar: Nein

Gestern auf dem CC.... somit hat auch der Vorstand nichts

[questionmark]

wenn der Vorstand Ergebnisse schon kennt, die noch nicht public sind, dann ist es Insiderwissen und sie dürfen nicht kaufen.
Von daher vielleicht eher ein gutes Zeichen ?

[Billabong00]

Antwort auf Beitrag Nr.: 74.822.393 von trufo324 am 17.11.23 12:28:55

Wenn alles entspannt wäre, würde der Kurs jetzt bei 30 EUR stehen oder höher. Wenn der Markt nach Veröffentlichung der Daten meint, das wird ein Ritt auf der Rasierklinge, ob das Teil mit den Daten zugelassen wird und JPK frohlockt mit der Aussage, wir werden alles versuchen eine Zulassung zu bekommen, dann ist bei 15 EUR nicht Schluss.

[tantemartha]

Zweite Frage: Vertrauen in die TSS50-Ergebnisse. Ich würde auf das zurückkommen, was ich zuvor erwähnt habe. Erstens ist Phase 2 bei Myelofibrose, wie wir kürzlich erfahren haben, sehr aussagekräftig für die Ergebnisse von Phase 3 in Bezug auf die SVR, wobei eine aktuelle Phase 3 die SVR-Reaktion für den Behandlungsarm und den Kontrollarm auf den Dezimalpunkt trifft. Und wie wir gerade in der Wells-Fargo-Frage besprochen haben, scheint sich auch TSS auf dem Rux-Kontrollarm im Vergleich zur historischen Kontrolle sehr gut zu verhalten, was uns Vertrauen in unsere Phase-3-Anzeige gibt.
Um noch einmal zu wiederholen, was wir zuvor gesagt haben, und Sie wissen sehr wohl, dass MorphoSys die Stichprobengröße von 310 auf 400 Patienten erhöht hat, als MorphoSys die MANIFEST-2-Studie von Constellation übernommen hat. Wir haben die Zahl der Eingeschriebenen auf 431 erhöht. Damit sind wir bestens für einen, wie wir erwarten, positiven Ausgang der Studie gerüstet. Zur letzten Frage bezüglich der Stromversorgung haben wir bereits gesagt, dass wir die Annahmen zur Stromversorgung nicht offengelegt haben. Angesichts der TSS-Antwortraten von 56 % in MANIFEST-2 Arm 3 und einer historischen Rux-Leistung, die den Erwartungen entspricht, sind wir von unseren Ergebnissen überzeugt.


Aus dem Call übersetzt

[RadarOReilly]

Was mich auch stutzig macht keine Meldung das jemand aus Vorstand mal paar Aktien kauft.

Das kam sonst immer mal vor um die Gemüter zu beruhigen wenn irgendwelche Daten in Erwartung waren…

Erwarte die Meldung eigentlich an einen Wochenende gibt nur noch zwei…

[tantemartha]

Aus dem Call ... Übersetzung Google: Hallo, Xian. Das ist wieder Tim. Zur ersten Frage: Verfügen wir über interne Daten? Die Antwort lautet ganz klar: Nein, wir haben keine internen Daten. Und wie wir in den vorbereiteten Bemerkungen erwähnt haben, werden wir die Daten, sobald wir sie haben, über diese Ad-hoc-Pressemitteilung zur Verfügung stellen. Und wir sagten, dass die Daten bis Ende November vorliegen würden.

[Turbocharlotte1]

Antwort auf Beitrag Nr.: 74.822.300 von Turbocharlotte1 am 17.11.23 12:16:33

Zitat von Turbocharlotte1:

Zitat von Ponyreiter: Solche Kursverluste ohne ersichtlichen Grund sind doch ein Warnsignal.
Und das bei einem positiven Gesamtmarkt.
Da ist bestimmt schon etwas durchgesickert.

... der Chart dürfte eines der wenigen und verlässlichen Signale für Privatanleger sein ... wären positive News im Anflug, könnte man das sicher am Chartbild ablesen; erst recht bei den im Raum stehenden Umsatzpotentialen ... glaubt hier irgendwer, dass eine sehr aussichtsreiche US- Firma durch Deutsche übernommen werden kann? ... ich nicht ... es läuft doch immer andersrum (siehe: Bayer, Daimler)

VG

... die harte Realität sieht doch wohl so aus:

MOR hat Constellation für ca. 1,7 Mrd. USD (!) übernommen, getragen von der Erwartung/Hoffnung auf Pelabresib ... Kohle dafür haben sie von Royalty Pharma bekommen und im Gegenzug insbesondere (nicht nur) ihre Rechte/Tantiemen an Tremfya abgetreten ... allein in Q1 - Q3/2023 haben sie damit 78,3 Mio EUR abgeliefert ... bei selbst ingesamt in diesem Zeitraum realisierten Tantiemen von 82,4 Mio EUR (die als Umsätze von MOR ausgewiesen werden, von denen sie exakt 0,00 selbst haben) macht das 95% (!); also nur 4,1 Mio EUR sind bei MOR verblieben ... und nun sage mir einer, das Management von MOR sei clever ... ich würde eher vermuten: the winner bei den deals ist: Royalty Pharma ... wenn man davon ausgeht, stellt sich unweigerlich die Frage, wieso Royalty Pharma den "Umweg" über MOR gegangen ist ... klingelts? ... die Vermutung liegt m.E. nahe: stupid german

m.E. wäre es clever gewesen, den deal Constellation nicht so zu machen, auf gar keinen Fall die Tremfya- Tantiemen abzugeben ... das war m.E. ein unverzeihlicher Fehler; allein in Q1- Q3 hat Tremfya ca. 2,2 Mrd USD Umsatz gebracht; ein Blockbuster

VG

[RadarOReilly]

Immer wieder interessant was die Leute hier schreiben ich glaube nicht an ein scheitern und im zweiten Satz selbst wenn die Punkte nicht erreicht werden.., es gibt ja nix besseres also nehmen sie was kommt.

Das sind die selben Leute die das Haar in der Suppe finden wenn die Daten raus sind weil sie sich mit Hebelprodukten eingedeckt haben!

Bin auf 17 Uhr gespannt wo der Kurs Heute landet ✈️

[NumanG]

Q3 CC Q&A Session

Ladies and gentlemen, at this time, we will begin the question-and-answer session. [Operator Instructions] The first question comes from the line of Derek Archila with Wells Fargo. Please go ahead.
Derek Archila
Hey, good morning, everyone, and thanks for taking the questions, and congrats on the progress here. So, just two questions from us. I guess, first, in the MANIFEST-2 trial, it looks like you enrolled more patients with intermediate-1 myelofibrosis, than you had kind of seen in cohorts. Trying to kind of get your thoughts on how that might impact the trial, in terms of SVR35 and TSS50. And then, also the second question, just looking at, some of these myelofibrosis trials, it looks to us, the mean change in TSS is highly variable across studies. This was most recently demonstrated with the navitoclax trial, but also with ruxolitinib. So, what do you think is really the main driver of this, variability? Thanks.
Tim Demuth
Hi, Derek. This is Tim. On the population in the MANIFEST Phase 2 study, and potential differences on SVR and TSS50, when we look at the JCO manuscript, Arm 3, we see very clearly that there is no difference in SVR response between the Int-1 and the Int-2/High population, confidence intervals are completely overlapping. The data for TSS50 has not been published. However, there is a waterfall plot in the JCO manuscript where you can derive numericals for patients with the respective risk categories. If you put then the confidence intervals around those, you will see that they are also completely overlapping. While yes, there may be small numerical differences, however, those are clearly related to the very small sample size.
On the variability, as you call it, on mean change in TSS baseline parameters between different historical studies and one of the more recent ones, in our perspective, this is really within the natural fluctuation of baseline scores. And I would even say that in the most recent Phase 3 readout that you are referring to, the 11 point change, absolute TSS change from baseline in the ruxolitinib Arm appears to be very well within the range of what one would expect from historical rux control Arm. If I put this together with the SVR response rates that was reported for that rux Arm, which is exactly in the line of what one would have expected, we actually feel very confident in the fact that the Phase 3 is a very good replica of Phase 2 results.
Derek Archila
Got it. Thank you very much. Look forward to the data.
Tim Demuth
Thank you.
Operator
The next question comes from the line of Xian Deng with UBS. Please go ahead.
Xian Deng
Hey. Thank you for taking my questions. Two, please, if I may. The first one is, just wondering if you could confirm whether you have got data in-house or not at this moment? And secondly is on TSS50, please. Just wondering, what sort of efficacy do you think that you need to hit statistical significance? Just any color on your confidence on hitting TSS50, that would be great. Thank you very much.
Tim Demuth
Hey, Xian. This is Tim, again. On the first question, do we have data in-house. The answer is very clearly, no, we don't have data in-house. And as we mentioned in the prepared remarks, as soon as we have the data, it will be made available through that ad-hoc press release. And we said the data would come by the end of November.
Second question, confidence on TSS50 results. I would go back to what I mentioned previously. First of all, Phase 2 in myelofibrosis, as we learned very recently, is very predictive of Phase 3 readout with respect to SVR, with a recent Phase 3 hitting on the decimal point on SVR response for the treatment arm and the control arm. And as we just discussed on the Wells Fargo question, also TSS seems to be very well-behaved on the rux control arm vis-a-vis historical control, giving us confidence in our Phase 3 readout.
Additionally, just to reiterate what we said before and you are very well aware of that, when MorphoSys took over the MANIFEST-2 study from Constellation, we increased the sample size from 310 to 400 patients. We over-enrolled to 431. And with that, we are very well set up for a, what we anticipate, a positive readout of the study. On the last question regarding powering, we said previously that we have not disclosed the powering assumptions. With the 56% TSS response rates in MANIFEST-2 Arm 3 and a historical rux performance within expectations, we do feel confident in our readout.
Xian Deng
Thank you very much.
Tim Demuth
Sure.
Operator
The next question comes from the line of Jason Butler with JMP. Please go ahead.
Jason Butler
Hi. Thanks for taking the questions and let me add my congrats on the progress as well. Jean, assuming positive results from MANIFEST-2, can you just walk us through the steps from that point to regulatory submissions? Are there ancillary studies that need to be completed? And is there anything time gating to submission? And then second question for me is just on reimbursement. Can you just talk about the work that you've done to prepare to get patient access for pelabresib and what -- any learnings or leverage from the Monjuvi experience? Thank you.
Jean-Paul Kress
Hey Jason. This is Jean-Paul. Thanks for your question. On the regulatory pathway, we are totally ready to roll the ball here. We've been having many interactions with the FDA and EMA as customary, and as you can expect. We'll be ready to share the relevant data and the globality of the data. That's also what I wanted to insist on. Beyond the two endpoints we mentioned, we have many other data sets that we will share with the regulators because it's our experience and our observation that the agencies have evolved and have been evolving lately, with, the way to apprehend this disease, as we've seen, for example, with momelotinib.
So, the totality of the data is also something very important. We've been mentioning that and we have a rich set of data. 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. Did they give any reason as to why they were hesitant? Was it cost? Was it efficacy? If you could give some color on that? And then a final one to squeeze in, just related to the question before on partnering. If you could let us know what you would look for in an ideal partner, should you choose the partner, that would be very useful. Thank you.
Jean-Paul Kress
Hey, Philippa. Thanks for the questions. So, on the first one, on the evolving landscape of myelofibrosis, including for the regulators, it all starts with this very high unmet medical need with the current -- same current standard of care for the -- for decades now and the appetite for new options. And again, as we've said several times, and we hear consistently, the combination in first-line is the number one opportunity to improve the standard of care here. That's very important for all stakeholders, including the regulators and the agencies. And based on our ongoing interactions, our experience, the recent approvals we've observed, even with mixed clinical trial results, this tells us that regulators will look at the totality of the data, inclusive of efficacy and safety results. Very important to keep in mind.
Now, on the market research question and the physician feedback. We've been -- we had a couple of those market research along the way since we acquired Constellation, and the great thing is that it has really, really evolved from two or three years ago when there was the novelty factor about combination. People were still a bit, wondering how they would do that first-line. And now we have an overwhelming number of physicians, more than 80%, both in community hematology and academic setting, who are ready for the combination first-line, which is great, and show how we have been imprinting the space with our engagements based on our Phase 2 data.
Your last question on partnering, again here, when you partner, you let value go. You have to be very cautious, Philippa. I mean we have the whole slate right now, so it's a great position to be in. Then, we will know more later. And again, if partnering would come in the discussion, I mean this is probably more for ex-U.S., and because we believe that we have what we need in the U.S., but we'll keep you posted on this one.
Philippa Pritchard
Great. Thank you.
Jean-Paul Kress
Thanks.
Operator
The next question comes from the line of Manos Mastorakis with Deutsche Bank. Please go ahead.
Manos Mastorakis
Thank you very much. Just quickly wanted to clarify, if you could give a bit more color actually, how important you think it is to show both SVR35 an TSS50? So, would an extremely positive outcome on one endpoint mitigate lower efficacy outcome on the other endpoint?
And also a commercial one. So, given the synergies in the salesforce with Monjuvi and pelabresib, in a scenario of ideal positive results, would you expect to see further investment into the salesforce? And thus, could we make an argument that Monjuvi sales could potentially benefit as a result? Thank you.
Tim Demuth
Hey, Manos. This is Tim. As Jean-Paul stated, based on the discussions with regulators, the assumption is, SVR35 and symptom improvement are important points that we'll look at. Ongoing interactions and experience from recent approvals in the myelofibrosis space with mixed results certainly tell us that regulators really appreciate the unmet needs in this patient population and that's what they are responding to.
In addition to spleen volume and symptomatology, we are also looking in the study at the changes, absolute as well as percent change in symptom score. We're looking at PFS, overall survival, and as I mentioned in the prepared remarks, duration of spleen and symptom response. And, we are confident that the comprehensive data set that we will be able to share at the time will really demonstrate and underscore the potential of the combination therapy to regulators.
Jean-Paul Kress
On your question two, regarding salesforce synergies, as mentioned, there is a very high overlap between the treaters, more than 80%, especially in the community hematology side. So, we would most likely need to do some incremental investments to have the right share of voice and, be just at the level of the opportunity here. But we are not going to start from scratch. It's qualitative and quantitative. Qualitatively, because we already know the targets and we have the relationships and the engagements well oiled, and also quantitative because it's not going to be a full buildup which would require more OpEx.
You ask about the Monjuvi benefit, well, for sure it's positive because you will have our reps out there and our medical affairs people having two products, which means the franchise, which means more commitment towards hematology. And with these two products on the market, we would definitely be as a leader which is virtuous.
Operator
Ladies and gentlemen, that was the last question. I hand back to you, Julia Neugebauer, for closing comments.

MorphoSys AG (MOR) Q3 2023 Earnings Call Transcript