Transcripts
Zealand Pharma A/S (ZEAL) Q1 2023 Earnings Call Transcript
Operator
[Operator Instructions] Your first question comes from the line of Charlie of Morgan Stanley. Your line is open.
Charlie Muir
Hi, Charlie Muir. Thanks for taking my questions. So firstly can you just provide any context around how the weight loss – were trending in the Phase 2 study of 46 weeks. Can you [Indiscernible] any more weight loss ago? And secondly could you provide an update on your discussions that Dasiglucagon partners in CHI as you approach filing? Thanks very much.
Adam Steensberg
Thank you Charlie. So first of all on the BI Collaboration for Blue GLP-1 we cannot share more data before ADA as we have communicated, we look very much forward to the conference and to discuss the data at that time. I would say if you look at other incretin-based therapies, then, of course, you can expect additional weight loss with time. That has been seen with any all other incretin-based therapies. But we cannot discuss the specific data in more details, except as David said before that we are highly encouraged with what we have seen so far.
On the Dasiglucagon CHI partner discussions, we are where we want to be, as we have communicated, we, our clients has all the time been to get the NDA packets completed and ready for submission and then start engaging in confidential discussions with potential commercial partners. So those are progressing as planned right now, and we also expect to open data room in the near-term and after then engage in more specific discussions. So things are progressing well, and according to plan there. Thank you.
Charlie Muir
Thanks.
Operator
Your next question comes from the line of Michael Novod of Nordea. Your line is open.
Michael Novod
Thanks a lot. It’s Michael Novod from Nordea. Also a couple of questions. Maybe just to give us just a bit of feeling around how your investments are being done. How much are you actually putting into to PCG this year and what is sort of the plan going forward, because it’s obvious that probably to invest in order to also gain all data and also try to use at some point in time for some of the early assets.
And then secondly, on Dapiglutide, the GLP-1 GLP-2, can you talk about sort of the ratio between GLP-1 and GLP-2? You gave us the ratio on the BI45 for GLP-1 versus glucagon maybe just be nice for us also to get the ratio around GLP-1 GLP-2. Thank you very much.
Adam Steensberg
Thank you, Michael. I will just shortly answer your second question first, and then I’ll hand over to Henriette. We have not released the specific ratio that we will provide at a coming scientific conference, and so we cannot come in details on it, but I can highlight that our approach for these dual acting peptides has been to make sure that they are biased towards activity on the GLP-1 receptor to make sure that we harvest the known benefits of GLP-1, and then just adding a little bit of additional pharmacology, just as we did with the BI compound.
So you have to wait with further data and specific data for this compound answer at conference, but it’s the same concept we are dying as we did with the glucagon GLP-1, and then Henriette will you take the other?
Henriette Wennicke
Hey, Michael, thanks for your question. So clearly we are investing heavily on BTT, and then we are putting all the investments into it to progress our BTT assets. Clearly at this stage, as we are progressing to us in the age for our rare diseases, as we are – these are also driving a lot of the cost you see. We are burning currently, but clearly as we follow these, we will also in the future invest in significantly more into our BTT assets as they progress. But clearly, everything we can put behind and we do at the moment.
Michael Novod
Okay, great. Thank you very much.
Operator
Your next question comes from the line of Jesper of Carnegie Investment Bank. Your line is open.
Jesper Ilsoe
Yes, thank you. Thanks so much. Firstly, on your GIP, can just provide some thoughts on this program given what we saw with Novos plus two data on [Indiscernible] with it and show any benefits on the HPNC and weight versus Cemarlo. So just updated thoughts, and whether or not to see this as impacting potential interest in this asset.
Then secondly, on the BI data, I understand you cannot come into the detail, but perhaps it’s just conceptually why didn’t all patients in the treatment arm reach maintenance — in the 46 weeks study. So just to understand why the potential reason for that, because I would assume that there’s plenty of time for it, and then I have to follow up. Thank you.
Adam Steensberg
Thank you. Thank you. Yes. I will just start and then I’ll hand over to David for further comments. On the GIP, I want to mention that we have to be, we have to bear in mind that all molecules are different. So and therefore, we are still excited about our GIP molecule when we evaluate our pre-clinical evidence. And we don’t have more insights into the Novo program than what was released a few days back, and that could be specific reasons why they decide to prioritize differently in their pipeline. But we have a confidence in our molecule based in the pre-clinical data, but as we have also said, the clinical evidence for the GIP as remains to be established.
And then again, on the BI program, we cannot comment too much more, but I will leave it to David to both provide further comments on GIP and also if we can provide more new items into the BI study. But it is really up for BI to provide these data at ADA, so we have to be a little bit mindful of that. David?
David Kendall
Yes. Thank you, Adam. And yes, for thanks. GIP, obviously, we like you saw these decisions from Novo on one of their programs. Interestingly, as I think they’re continuing another program on the oral side with the combination of GLP-1 and GIP. As Adam said, we are quite pleased with our GIP agonist based on the non-clinical data, which we presented in some detail at last years, so basically, week meetings and given the complexities now of GIP, glepaglutide, presumably, carrying an agonist component in that molecule, the Amgen asset, antagonist to GIP, I think there is likely much to be learned about the pharmacology of GIP and clearly based on those data from Lily and Amgen and our own non-clinical data we believe that GIP still has a very important potential role as an adjunct to other incretin and non-incretin based therapies. But obviously, we’re looking very closely at what data will be made available from the Novo program to make decisions on our own.
On the BI asset, as Adam said, we are both mindful of and respectful of the embargo that’s the American diabetes association is placed. So granular detail on that program and the protocol can’t be provided. But suffice it to say that Phase 2b is most importantly, dose ranking, dose finding activity to ensure that we have an understanding of both the dosing and the titration scheme and in this program like many others, there was an opportunity for the investigators to modify the titration during the active titration scheme. The details of this will be outlined in the full numbers of subjects in what is essentially an intention to treat versus the protocol populations who are excited to share how the upcoming scientific sessions.
So without pre-empting that presentation, that’s the detail. Maybe an example is if someone had potentially tolerability issues that would give the investigators discretion in this and other days to dose ranking studies to alter that titration scheme so that we have a better understanding to inform the full Phase 3 program once those decisions are made.
Jesper Ilsoe
Okay, perfect. Just one additional question on glepaglutide from me. So, just perhaps you include some additional comments on the note in your report about additional patients screening of parental support, as well as whether on these long-term extensive studies, what you’ve seen so far, that’s more confident on the potential with glepaglutide.
David Kendall
Yes, I’m happy to start Jesper and Adam, if you have additional comments, I’ll turn it back to you. But certainly we’re excited by having at least our initial look at the data readouts from the long-term extension. Both trials are on-going. We’ve made the interim data cuts in both extension trials and I’ll just summarize by saying we’re both very pleased and the results are consistent and a continued clinical effect is certainly being observed.
Again, without pre-empting all of the full data sets, the issues of internal autonomy and continued reductions in PS, those results are certainly very encouraging and we think continue to strength to the results of these one. And additional safety exposure, obviously, which is important for the ultimate regulatory submission. Adam, any additional comments from you?
Adam Steensberg
No, thanks, David.
Operator
Your next question comes from the line of Peter Wolford [Ph] of Jeffries. Your line is open.
Unidentified Analyst
Hi, thanks. I’ve got four very quick ones. Firstly, and sorry if I’m being stupid about this, but just coming back to the 906 maintenance first, that’s actual. And I’m asking for the data, which is so I can understand. We say then that the planned maintenance dose is basically a protocol of analysis, so those people that didn’t make it to their dose, they were assigned a not included, whereas the actual maintenance dose is 90T. So patients are included regardless of what dose they got to in that arm to actually, some patients in the ITT analysis would be on a lower dose than was originally planned, but actually you’re getting more weight loss when you do the ITT analysis, including those patients. Is that right? Secondly, then, sorry, sorry, I’ll just be all gone.
Adam Steensberg
Thank you, Peter. I’ll just follow up on David’s note, and then we really have to be mindful of how the data is embargoed, but I think what is important to understand is the key element is that when you design these Phase 2 studies, of course you can just, you can design them, just to try to achieve the most weight loss that you want, or you can design them into a best informed decision making for how to design Phase 3.
And then, of course, given way to evaluate these data sets. And the data that we have released here for the, for the, that came out yesterday are on the, from the patients for based on the groups that they were randomized into. And in order to, you can say, following the dosing type tracing theory at the first 20, 20 weeks, investigators were allowed not to fully get up to the highest dose. And you can say, the data that will come later at ADA is an analysis of those patients who actually was good up to the highest dose and then maintained on that for the remainder 26 weeks of the study.
So, and then, of course, when you do Phase 3 studies, you will design it a little bit different these kind of things. I mean, you will not keep the fixed dose after 20 weeks and so on. So, we are extremely encouraged by the data and we will very much forward to share them, but I really think we need the full data set to understand the details more.
Unidentified Analyst
Yes, sorry, sorry, sorry. Sorry, I got the amendment says it around for, so yes, so what we are saying is, is when you say the actual maintenance does, what we are saying is the, protocol, in other words, the people are actually indeed…
Adam Steensberg
Is that patient who reached the highest. These are patients who were dosed — that they were randomized to.
Unidentified Analyst
Yes, yes, got it. Okay, fine. And okay. And then, just, secondly then, just on the NASH study. Am I right in saying we’re still anticipating NASH data later to stay at 906?
David Kendall
I’m happy to…yes go ahead Adam.
Adam Steensberg
Please take that David on the NASH Phase 2 study.
David Kendall
Yes, so the NASH Phase 2 study Peter is fully enrolled, and the data continued to be accumulated. So, we await the future data readouts. I’m one, the last, the last patient last visit and obviously the database is locked. So the diabetes, or the, I’m sorry, the obesity study that we present at ADA is that that was specifically designed to assess weight management and overweight and obese individuals. So, the NASH study is forthcoming and on-going, fully randomized, and we look forward to those results upcoming.\
Unidentified Analyst
That’s great. And then…sorry.
Adam Steensberg
No BI regarding that [Indiscernible] complete the study this year, and then we don’t know when it will be reported, but dived in early next year.
Unidentified Analyst
Got it. Okay, and then just so I understand the, on the financials, there’s two very quick ones, firstly, the, the income booked from Novo in the revenue line, the DKK30 million. Is that all the straight royalty income or is some of that 13 money, Novo is paying for drug or something else for the residual, just trying to understand how we should think about that going forward?
And then just on the revolver, curious, have you actually pulled down the 350 million revolver in May, to pay the Oberland or is that just a facility that’s available to you? I guess, given your cash balance, it doesn’t seem immediately obvious, necessarily why you did pull on the revolver now, given, DKK2.5 billion available to the race. Thank you.
Henriette Wennicke
Yes, thank you, Peter. Henriette here. Let me come at that. So, the Novo is a split of royalties and our activities we’re conducting together with Novo. So, that will be a split because they’re hitting the top line there. And regards to the rolling credit facility there you’re right. We are not rolling it down at the moment but it’s available to us which I think is an important point and I think it is the system and that you can actually establish a revolving credit facility at this point in time and are caused at the terms a significantly different from what we had on the previous facility we had in place.
Unidentified Analyst
That’s great. And sorry can you give us any sort of idea of because obviously Novo is probably never going to report a regular task. So can you give us some sort of idea of what proportion is royalty. I guess I’m just curious when we think about 2Q, 3Q, 4Q. I mean how should we think about at all what you booked at 1Q has in anyway recurring if you like well what but is there any proportion or something you can give a royalty to help us. Thank you.
Henriette Wennicke
Yes, of course we cannot comment on the specific details here, but I think of course it is a mix on and you’re right. At the moment the level is right is, but what it is a mix, so we cannot comment on the details of the contracts of how much it’s a — you could say then royalties on how much it’s at all the activities you’re conducting. But we have a question to what’s defiling in Europe and that’s of course also included in the numbers the activity that’s conducted on the debt agreement.
Adam Steensberg
And Peter maybe just for me to follow up, I think compared to all of our other activities in the pipeline both in rare disease and obesity these near term we do not see this has been very material numbers for Zealand Pharma but it’s an important agreement and it’s an important and important product for the patients we believe but it’s not a very important material that and we will not expect that to change significant in the near term.
Unidentified Analyst
That’s great, thank you.
Operator
Your next question comes from the line of Rajat Sharma of Goldman Sachs. Your line is open.
Rajat Sharma
Okay perfect. Thanks for taking my question. So first one on amylin. Just could you help us think about what your expectations are for the MAD data in the second half of the year are you looking for weight reductions in line with what we saw in the single ascending dose.
And then just on that asset and you can you talk about amylin and potential combinations when might you think about combination trials for your amylin agonist. And then just one on the GLP-1 receptor agonist, how, what are you thinking about kind of acceptable levels of GI related AEs. I think there was some comments in the media by your partner the AI yesterday that talks about the AE profile being in line with what we’re seeing with other kind of commercial and late stage or BC [Ph] therapies, so could you just help us think about that? Thanks.
Adam Steensberg
So I will, thank you for the questions. On the amylin I think we should not speculate too much because data is always data and the study is on-going. But it’s fair and David you can comment more on this in the minute but it’s fair to say as David also mentioned it’s a two past started the month ago sending those first six weeks study and then moving on 16 weeks. So I will say the focus for us that the six weeks study is to serve as a bridge towards getting the 16 weeks study started where we also have higher doses. So but of course you can say we wouldn’t see the weight loss also in the six weeks study since we observed after only one dose and after one week 4.2% weight loss in the single ascending doses study. So but David you can comment more on that on the PI collaboration on side effects. I think we will stick with the note that the PI could out and I think we have been very much to it, — to once alone for its sort of ability issues which can also be managed by titration to a large extent and I think with how BI positioned this this is also our view and then specific data started to that. But it’s again ADA. David any comments of further integrations?
David Kendall
Yes I think just add some flavor to the amylin question Rajat. I think qualitatively given what we saw in ascending dose we would certainly anticipate even in the MAD part one as we describe it the six weeks study to hypothesize that they would be results that are qualitatively similar. To Adam’s point, the second component of that which is longer duration including individuals who are overweight and obese and titrating to higher doses again to inform Phase 2 planning, we hope will give us a much broader brush of both the clinical response and the dosing regimen that we may be applying in future studies. So I don’t want to get ahead of ourselves and speculate on the actual numbers. As regards combination trials as you know the regulatory path is somewhat sophisticated, so our near-term plans are to take this forward as a standalone asset to better understand its individual contribution but obviously there’s an opportunity particularly with other approved assets for the management of obesity on the market to assess these in combination in later phase trial so those are considerations but the focus on the near-term is for the monotherapy assessment.
And into Adam’s point I think we’ve seen both with higher dose transacted, higher dose semaglutide sort of the broad brush of what happens at the GI side effects as you have more potent or higher exposure to GLP1 agonism and stick with the BI comments as well but the results we have seen and we’ll report in just a few weeks should be consistent with those.
Rajat Sharma
Perfect thank you.
David Kendall
Thanks Rajat.
Operator
[Operator Instructions] There are no further questions at this time and I’d like to turn the call back over to Adam.
Adam Steensberg
Yes I don’t know if you can hear us. I think we lost connection again a little bit but if you can then we would like to thank you all for attending and for your questions today and we will be very much forward to connecting on future announcements and updates. Thank you all. Operator?
Operator
This concludes today’s conference call. You may now disconnect.