Zealand Pharma A/S
Q3 2020 Earnings Call Transcript

Published: 12 Nov 2020

[Operator:]

Ladies and gentlemen, thank you for standing by and welcome to the Zealand Pharma Results for Q3 2020. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. I must advise you that the call is being recorded today, Thursday 12, November, 2020. And without any further delay, I would now like to hand over the call to your first speaker today, Mr. Mads Kronborg. Thank you. Please go ahead.

[Mads Kronborg:]

Thank you, operator. Welcome and thank you for joining us today to discuss Zealand’s third quarter 2020 financial results. With me today are Zealand’s Chief Executive Officer, Emmanuel Dulac; Chief Financial Officer, Matt Dallas; and Chief Medical Officer, Adam Steensberg. The team will respectively provide business, financial, and development highlights from the third quarter of 2020. After the prepared remarks, we will open the call to take your questions. You can find our Q3 2020 interim report and additional supporting information on our website at zealandpharma.com. As a company headquartered in Denmark, our financials are reported in Danish crowns, also referred to as krone. Key figures may have been converted to US dollars for convenience. I would like to point out that we will be making forward-looking statements that are subject to risks and uncertainties. These statements are valid only as of today and the company assumes no obligation to update them, except as required by law. Please refer to recent filings for a more complete picture of risks and other factors. With that, I will turn the call over to CEO, Emmanuel Dulac.

[Emmanuel Dulac:]

Thank you, Mads. And thanks to everyone for joining today. As the world is weathering it’s eight months of the COVID-19 pandemic, Zealand Pharma continues to advance on our plans and commitments during strong third quarter. We are preparing for first commercial launch of the dasiglucagon HypoPal rescue pen, for which we expect to receive notification on the U.S. FDA approval in March. We also continue to leverage our innovative peptide platform for early access, while advancing the clinical development of our late stage pipeline. Our organization has made significant progress this quarter, and we are looking forward to several upcoming key clinical and regulatory milestones, which will support our mission of transforming patient lives through peptides innovations and novel treatment solutions. On the clinical front, we are excited to share the news of completion of the Phase 1a single-ascending dose trial with dapiglutide, previously referred to as ZP7570. Dapiglutide is a long acting GLP-1/GLP-2 dual agonist, currently in development for short bowel syndrome. In the trial, dapiglutide was found to have a good safety and tolerability profile, and we observed a half-life, allowing for once weekly dosing. Encouraged by these results, key operation immediately started dosing the first participants in a Phase 1b multiple ascending dose trial. This dual agonist program is a first attempt to advance the combination therapy for SBS patients, which we believe could represent the next-generation of treatments.

[Matt Dallas:]

Thanks, Emmanuel. On slide six, you will see Zealand's income statement for the first nine months of the year, and how it compares to the same period in 2019. Total revenue for the first nine months was DKK 290 million or US$45.6 million. This was driven by net sales of V-Go, a Phase 2 milestone payment triggered in June, for our partnership agreement with Boehringer Ingelheim and revenue recognition related to our collaboration with Alexion. The net operating result for the first nine months was a loss of DKK 449.1 million or US$70.6 million. Sales and marketing costs mainly relate to the V-Go program, the quietest part of the Valeritas asset purchase agreement in April, while R&D cost mainly relate to the regulatory efforts to support the NDA filing for the HypoPal rescue pen, as well as clinical development of dasiglucagon and glepaglutide programs and preclinical research activities. Slide seven illustrates our strong financial position and ability to support our growing business through continued investments. Net operating expenses for the first nine months of 2020 were DKK 714.5 million or US$112.3 million. At the end of the third quarter of 2020, we had a cash position of DKK 1.53 billion or US$240.4 million, funding the company through several key upcoming milestones.

[Adam Steensberg:]

Thank you, Matt. So on slide nine, you will see our robust pipeline on peptide drugs for metabolic and gastrointestinal diseases. And with the Phase 3 readout for dasiglucagon in CHI expected next month, I would like firstly to talk about the disease and our comprehensive Phase 3 program. So please turn to page or slide 10. So CHI is an ultra-rare disease affecting around 1 in 25,000 to 50,000 newborns in the U.S. and E.U., every year. It's a devastating condition, carrying a very high risk of organ damage due to the repeated episodes of low blood sugar levels and a high proportion of patients with abnormal neurodevelopment. As you can imagine CHI also greatly affects the patient's parents and the relatives of the patients, and the current treatment options are limited and carries a high risk of side effects. The unmet medical need is huge, and we believe that dasiglucagon has potential to improve management of this disease. Please turn to slide 11. While you can see the comprehensive Phase 3 program, spanning children from age only 7 days to 12 years, which allows us to collect data across the patient population. All participants are offered a continuation in our open label extension study, from which we will be collecting long term data. To-date, we have 29 out of 32 participants in trial 17109, who have continued in the extension study. The second trial, 17 103 is ongoing, with three children having completed the trial and also ended the long-term extension study. The expected safety readout for the latter is 2021. On slide, 12, you will see the design and the key endpoint in Trial 17 109. To be included in the trial, the children had to be between three months and 12 years of age and experienced three or more events of hypoglycemia per week, despite being a standard-of-care.

[Emmanuel Dulac:]

Thank you again. And thank you, Matt. Please turn to slide 15, 2020 has been a significant year for Zealand. I am pleased with the organization's progress to achieving our objectives in the first nine months of the year. And even more so considering the challenges presented to us by COVID-19, which our employees have overcome with strong resilience and great agility. This makes me proud to be part of this unique company. Encouraged by these results, we continue to advance all our R&D program as well as our U.S. commercial organization and preparations for the anticipated launch of HypoPal next year. We are committed to deliver on our commitments to patients and remain on track to realize our ambition of adding five products in the market by 2025. Every day, we work towards fulfilling the significant potential of Zealand and realizing our vision of transforming patient lives. With that, we're now ready to take your questions. Operator?

[Operator:]

So our first question is from the line of Michael Novod from Nordea. Thank you. Please ask your question.

[Michael Novod:]

Thank you very much. This is Michael Novod from the Nordea in Copenhagen. A few questions, first of all just a clarification on dasiglucagon and CHI. So you've previously noted that the you would file when you sold the readout of the second trail. I don't know, Adam, whether I heard you correctly, that you will now, if you see good data, then you will engage with authorities since you will even file on this first trial. Just a clarification on that? And then secondly on the package side, if you do see substantial delays to further enrollment, do you have, or do you see ways where you can do a analysis on the patients that have already been enrolled and treat, or do you have to complete with full enrollment of the trial and hence just, you know get past the potential delays? Those were the two prime questions. Thank you.

[Emmanuel Dulac:]

Thank you, Michael. And then I think I will address those questions. So if we start with the CHI first, it is actually -- it is correct that once we see the data, we will evaluate the opportunity to potentially final only one study, as you also saw on the slides, it's actually a study where we cover the age span from three months to 12, years. And we have a very broad representation of different age groups in this audience. And since we're talking about an ultra rare indication and actually a rather large study of 32 children, and also highlighting the number of children we have in the extension study, and it was to collect actually safety data for more than one and a half year in some children. We would anticipate to engage in discussions with regulators and how we could find on that study alone, and maybe supplement this study from the smaller children. But again, we need to see the data and then they advance from there. But correctly that is, yeah…

[Matt Dallas:]

As you also recognize here, we are working, as we have said all the time, very close with investigators, clinical trial and regulators to see what we can do to address all the burden that COVID situation has put on the center's. The key point for us is, of course, first of all to secure patient safety studies, which we have very good control, and then the quality of the data and trial integrity. I mean it is a Phase 3 study and we cannot compromise on getting the right quality. With regard to other measures, we could take to potentially accelerate a timeline, and so on these we are exploring all options and what we can say is we -- as we know more about when we will have results we will inform the market.

[Michael Novod:]

Thank you.

[Operator:]

Thank you. The next question is from the line of Graig Suvannavejh from Goldman Sachs. Thank you. Please ask your question. Graig, your line is now open. Please go ahead.

[Graig Suvannavejh:]

Yes. Thank you very much. Sorry about that. Good afternoon and good morning everyone, and thanks for taking my questions, and congrats on the progress in the quarter. Just if I could ask a first question on glepaglutide, and on the slowing enrollment, I'm just curious if – is this more of an issue about being able to open up clinical trial sites, or is it really more of an issue of getting patients to those sites and you may have kind of addressed this in the last question, but what are the -- what can you do to get that to a place in terms of enrollment speed, where you're more comfortable or simply we just have to wait until COVID goes away and you can get enrollment back up to where it needs to be?

[Emmanuel Dulac:]

Graig, I think, Adam will take this one again.

[Adam Steensberg:]

It's a good question and I think it's actually a combination and it's a little bit the same features we have discussed before. We have yet some type, but still have to able to close them down if we see a renewed site and so on. Yes, UK has been extremely tough. I mean, hurt by the COVID situation and we have had a continuous struggle in those times, U.S. Senator and we are seeing some signs at a number of sites, which are very active and others who are more careful. And it's the same situation in Europe where we actually have sites, which can maintain activities and others who can. So – and that's why we -- it's a very individual approach we have for each sites, but for some time we have a, I mean, you would also see that from other studies even enrolled – enrolling patients from the pivotal part of the study to the extension task, we were not able to do that, because the local ethical committees and so on saw that as a new study, meaning that what seems to just be an – you can say a technicality, we actually had I mean, the studies and keep the pace in the main study until this had allowed patients to roll into new studies. So these are the logistical challenges we have been dealing with the site investigators, and we have overcome them. As we've also said, we go for all patients who already randomized. They are also secured new randomizations, new screenings throughout the period but it's just much more prioritized for our so on so to handle all this. So that's slow content a little bit. And then there is also – there has been among patient some – we have heard patients who have been willing to come into the dasiglucagon who have to wait a few months until we get in because we now are concerned about the number of infections in our area and so on, so it's a combination of both. And that's where we are handling the situation on so many levels, I would say, but we are – we can say at almost in weekly dialogues with all the trial sites and so on to make sure that we always accommodate what they need and how to change things. So we are working very, very diligently with it. But one thing we cannot compromise on is the quality, so we cannot just open up the study and let go of the quality aspects of the data collection because ultimately, when we get the data, it is down to having conducted the study to a level where we have good quality data, which is to serve a regulatory filing.

[Graig Suvannavejh:]

Okay. It’s helpful. Thank you very much. Just the next question is on V-Go and I'm just curious as to – as we start approaching 2021. And maybe this is a question, I guess any of you can answer the question. How should we be thinking about Zealand’s efforts in trying to drive future growth of that product and how much of a priority is it vis-à-vis all the other clinical trial activities that you've got going on, is the goal really just to maintain it where it is? Is it really to drive it going forward just wondering kind of how you're thinking about that.

[Adam Steensberg:]

That’s a good question. That's a question that our U.S. team right now is actually really assessing in terms of resource allocation and priority. The priority is definitely on the launch. I mean we want to make sure that we successfully launching our first product. It’s a first launch for Zealand Pharma. It’s the fist launch for dasiglucagon, the first indication for this together. So it is really important for us to actually do the best we can on this one. As you know, it's not very large indication as well, the rescue market, but it is actually simply for us in terms of making sure that we do everything that we plan to do on this one. V-Go product is actually a great revenue generation asset right now. Any dollar on V-Go is a good dollar to get. It's great as well because it gets our team, you know, facing reality so they are actually engaging with payers facing the new post covariance world. They are testing new platforms, digital platforms, engaging digitally with doctors, they are learning, you know, again, a new map of the U.S., some doctors used to see reps, and they don't see reps anymore, so we are actually getting a lot of insight and intelligence on this front, which allows us to redeploy according to this – our resource. But that's where we are still doing the assessment of, you know, how do we prioritize resources. Right now, V-Go is the only product that they have in their hands. So until we get positive approval from -- for HypoPal with Japan, V-Go is actually a V product that the sales force is pushing.

[Graig Suvannavejh:]

Okay. Thank you. And maybe just one last question if I could, just on the earlier stage pipeline. I think you've assembled some interesting assets, just wondering if there might be either. Any update you can provide now, or if there's a time in the future that you could point us to, where we might then be able to learn on how some of those projects are progressing? Thanks.

[Emmanuel Dulac:]

Yes. I think the one thing that we did highlight at this call and that what the progress we've made with glepaglutide, our GLP-1, GLP-2 analog for -- which is in development also for short bowel syndrome. I think that's a very-very interesting and promising molecule, where we actually managed to complete the Phase 1a in Q3 and then also started multiple ascending dose. It's actually a program that has multiple opportunities beyond SBS. And the profile of the drug, so far what we have seen is, very-very promising. So you should expect to hear more from that, as I mentioned. Then on some of the earlier pipeline products, our segue there with -- by the end of Q1 on that area, that is probably why you should expect us to provide a most firm update and also an R&D day where we can talk more about these opportunities. As we have said, we are actually making good progress in some of these programs and we believe we have some very-very interesting opportunities that could turn out to be -- also entering the clinic in the coming years. But that for an R&D day and actually that's Q1, at that time. Yes.

[Graig Suvannavejh:]

Okay. Thank you.

[Operator:]

Next question is from the line of Alan Carr from Needham & Co. Thank you. Please ask your question.

[Alan Carr:]

Hi. Thanks for taking my questions. I want to talk about preparations for HypoPal on the -- from a CMC perspective. Any, any risks around that? And have you completed everything you need to do around CMC. Do you think you'll be able to launch HypoPal right after approval? And then, with respect to 7570, what is your -- is your plan to go straight to short bowel syndrome? You hinted at other indications, but is the plan after you finish the med to do a Phase 2 in short vowel? Thanks.

[Emmanuel Dulac:]

Yes. So, regarding CMC and, as you know, in the FDA reviews, this is one of the area that has a lot of scrutiny. So we're getting, I would say, a lot of questions from the FDA. So far, no, I would say, signals of major challenge. I think this is working as expected, but it's an area where they spend a lot of time and attention. We are confident, where we are today. And I think it's progressing well. Related to 7570, maybe, Adam, you want to quickly explain.

[Adam Steensberg:]

I think we alluded to that they are different opportunities with 7570 and the indications. But for sure, when we talk about SBS, what we have seen also in preclinical models and from the loose combination studies that have been conducted by other investigators, it has a high potential in SBS. So that is our key focus, but we are of course discussing if we should go beyond that, because we believe the mode of action and the dual pharmacology really could have potentially in other indications beyond SBS. Both molecule -- GLP-1 and GLP-2 components are super potent molecules and then you can come up with a number of indications where this could actually be a benefit. So, again, potentially -- next year is where we will share more on our cost on these -- on what we do with 7570 and at that time, we will also progress further into the multiple ascending dose study, but it is clearly a priority program for Zealand.

[Alan Carr:]

Yeah, I was just asking because it seems like it -- with the Phase 3 for glepaglutide carrying on, I wondered if there was enough of a -- when you think about the next drug coming along for SBS, you're not too far behind the first one. I was wondering how you were thinking about this strategically?

[Adam Steensberg:]

That's a good point and then you can say that, of course, you would have to do our Phase 2 study with 7570 before we would understand the full differentiation potential with 7570. From what we have seen so far, also increasing on the study and so on, it looks that it can provide very significant additional benefits also from the clinical testing of those combinations, but you are, of course, right, that is based on the Phase 2 data, the depreciation is not -- enough and it wouldn't be so logical to pursue in SBS. But that's also why we are excited about other opportunities, which we look forward to discuss more once we have been defined a little bit more.

[Alan Carr:]

Sure. And then it took to clarify the time for HypoPal launch, would you be ready to go right after the PDUFA date or would there be lag by weeks or months?

[Emmanuel Dulac:]

Our plan is to be launch-ready at PDUFA date. So, we -- our teams will be there, fully staffed trained. The launch -- effective launch as you know it takes a few more weeks to -- because you get the label basically on PDUFA date. So, we need to get the -- this product produced, printed and then there's drugging the channels on summary, so it takes you more weeks. The plan is what we can control, which is launch readiness. The plan is to be launch-ready at PDUFA date for the teams.

[Alan Carr:]

Great. Thanks for taking my questions.

[Operator:]

Thank you. The next question is from the line Etzer Darout from Guggenheim. Thank you. Please ask your question.

[Etzer Darout:]

Thanks for taking questions. First one I guess there's another follow-up to ZP7570, just wondered if there are any comparisons you can make thus far on biomarkers of disease between ZP757 and glepaglutide based on the pharmacodynamic endpoints you measured in the single ascending dose study. And then I have a second question.

[Emmanuel Dulac:]

Yeah, there will be -- but we actually do not have the full data set on those yet, so that will be again later and probably something we will share at scientific conference.

[Etzer Darout:]

Got it. And then on the dual-hormone pump program, if first patient is dosed as planned in the insulin trail and in those fourth quarter, wondered if you could talk a little bit about the development, sort of scenario timelines for the dual-hormone pump trial and when we could see that that data and whether or not a 2023 launch for this program feasible.

[Emmanuel Dulac:]

Yes, so it is a program as we have discussed before, we hope to see that they see starting this year, but then we're -- and as state department has communicated all the time. They wanted to initiate the insulin-only and get the patients going in dasiglucagon at our study. So it has moved into next year, but as Emmanuel also chat in that we are very confident in those timelines. And then -- so we feel fully focused and thanks to get going to get a piece of dasiglucagon phase 3 study next year. At that time, we should also have completed our interactions with FDA on the they are going to face 2 reason and so on. Those -- we will have them in the coming months -- we anticipate in the coming months, so we should be very, you can say firm also on those aspects. What I can say, a lot of the timing on when we can launch of course, depends on how fast we can recruit the patients. The fact is it's a six months study, so that kind of defines the time once we have -- patient in. So it will be hugely interesting to see the speed at which CHI connected with pivotal insulin-only study which is a 440 patients study where they managed to ramp to see all patients in a couple of weeks. I think six weeks or so, and then it took a little bit longer to get those going and because they had to change and accommodate COVID situation. So if we can repeat that, then you should expect to see some very fast progress on CHI that Phase 3 with the dual hormone. I think the other aspects that we keep highlighting is that, it's actually a very, very good scenario to be in that the items get tested in the insulin only setting before we sign our dual hormone. So we have the opportunity to just make small adjustments also to the protocol, as it’s a difficult learnings and so on. So we hope that with the learnings and the experience that the team is getting right now from the insulin only which we will be able to maintain speed once we get to the dual hormone.

[Adam Steensberg:]

I think you sit at defensive sides and the patients are able to get…

[Matt Dallas:]

Less effective and that the 440 patients should be able to enrol into our study as well. So that would, again add to speed of recruitment.

[Etzer Darout:]

All right. Got it. Thank you.

[Operator:]

Next question is from the line of Lucy Codrington from Jefferies. Thank you. Please ask your question.

[Q – Lucy Codrington:]

Thank you for taking my questions. I've only got a few left. And just firstly, just back on the artificial pancreas, I believe we have been expecting the insulin only study to start the dosing during 3Q and it now seems to have been pushed into 4Q. I'm assuming that again is related to COVID, but with lockdowns increasing, is there a risk that that could be delayed further? I do appreciate it. It's not your study, but if you have any thoughts on that? And then just on glepaglutide side, just to confirm, a patients who are already in the study and treated, are they still able to continue? There hasn't been any compromise to their data. And if possible, if you could give a rough percentage of patients that have been recruited, I believe around in 1Q it was around 50%. I wonder if we've made much progress since then? And then secondly -- thirdly, regarding sales and marketing, just how -- obviously there's been the ramp with V-Go and we're prepping for the dasiglucagon launch into 2021. How should we be thinking about it relative to this year? Thank you.

[Adam Steensberg:]

I address the two questions. Emmanuel you can address the sales and marketing question. But specifically two amazing long year and just the case and then to recruit patients with the new sites, once we they had new -- you can say updates to the protocol, so that it’s truly a remote team that they can do most, if not all on a remote basis, which means that they should not be impacted. That's our understanding by the review sites. And they have the patient already raised us to be randomized to do so. So what we see right now, we don't have any concerns with that specific study. As we have said before, and this is also the case, though, that all the patients who were screened or randomized in the world in the study, we were able to continue to provide them the graph. And we were also able to continue to provide contextual data quality, making sure that we get the right measures into base our adjustments and here and so on. So this is where we have -- that was our number one focus on patient safety, we want to secure the quality of the data and so and that we believe we have done extremely well. So we have – and we have not lost patience. And this is what I was referring to before it is just an example that we had to admit the need to keep some patients in the study, because specific sites will not allow them to roll into the extension study. And so they will have to -- they have to stay beyond six months in the main study. But those things we did in order to make sure we did not lose patience and maintain the integrity of the data set and so on. So we don't see anything that -- we cannot comment on specific numbers on recruitment, but we are beyond halfway into study, which we appreciate and we have still around 39 tenders active in the study. So we feel we are in a good trajectory. But we also know that it's going to be hard work.

[Matt Dallas:]

On the sales and marketing team. I'm very proud of the team that we've got. And the leadership positions have already been filled or will be filled ahead of the PDUFA date with or without COVID.

[Lucy Codrington:]

Okay. Thank you.

[Adam Steensberg:]

Thank you.

[Operator:]

The next question is from the line of Peter Sehested from Handelsbanken. Thank you. You may ask your question.

[Peter Sehested:]

It’s Peter Sehested from Handelsbanken. Thank you for taking my question. Phase 1b study and ZP7570 scheduled to end in June, how far can you move into Phase 2? And secondly, we've previously talked about your expectations for ramp up of high propel sales. I think you indicated that we should expect a slow launch and an acceleration after that, in that respect, are you comfortable with the, I mean, just a few numbers but nevertheless, with the numbers that you can see for instance on Bloomberg, a consensus around 100 million sales of next year, and then 270 in the year thereafter? And then just finally, if you could just remind us about the step patent expiry for glepaglutide on?

[Emmanuel Dulac:]

Okay. Patent expiry for glepaglutide. 7570, It's a multiple clinical study. And as you can see glepaglutide set up, currently we can with three dose levels, so -- but you need to see the data before you end up being completely firm on when you can finalize the study. Of course, we would be able to start a Phase 2 study quite quickly after that, as you know, with Phase 1 study you have access to data on an ongoing basis. So it's not that we have to wait a long time before we take decisions. But again, this is where we plan to update early next year, now faster that molecule. Later we have different patents, protecting glepaglutide including formulations and so on, but the competition of metastatin has a date in 26 but then you will have to add up to five years extension based on what you can gain on two to three time the pending development. So that would likely take us into the third studies, so and then we, as you know, we also have orphan drug designation in the U.S. with this molecule. Do you want to take the next…

[Peter Sehested:]

And then very strong combination.

[Emmanuel Dulac:]

Yes. So and then for the HypoPal, yeah Matt, you should take it.

[Matt Dallas:]

Yes, on the HypoPal, we have not issued guidance, nor willing to be issuing guidance in the near-term. We haven't guided, the PDUFA date is still number of months away. So not until we get through that point. And then more commercial plans are outlined where we start kind of focusing on near or short-term revenue expectations on the launch there.

[Peter Sehested:]

Okay. Thank you. Just a perhaps this final one before I hop back into to the queue. What should we see as a clinically significant outcome in the CHI study? Thank you.

[Emmanuel Dulac:]

Yeah, we – I will actually wait to comment on that. Because, of course, it depends on the level of the number of hypoglycemic events, the patients enter with, as I said, the minimum is three events per week. If you have nine and you reduce that to five, that could be very significant. If you have three, and you only reduce that by one, I mean, you still significant – clinical significant I mean, we need to see the severity, and have the full overview of that – of the patient's house when they enter the study. I think for me, as I said before, one of the key other factors is actually one of the key secondary endpoints which is affiliated to France. We know for many patients and their caregivers, they have to wake up several times a night to feed the children to get through tubes and so on, because they cannot tolerate fasting. So if you can expand that one as well. That is one where it will have a major impact on the quality of life. It’s not of not only the patients but their parents and caregivers. So with small studies like this is actually not just down to the primary endpoint, it will be the totality of the data as they read out and how they kind of communicate. You will also see that in our extension study, we have called safe stability to reduce other standard-of-care treatments and as I mentioned in my introductory notes, that a lot of side effects with these things and they have – many patients are being dosed far beyond, what you should use of doses with this, so if we can reduce that that's another thing. So ultimately, it will be the clarity of the data that will guide how attractive this treatment is. What encouraged us about is that so many patients have actually decided to stay in treatment in the extension study. And again, I just have to highlight. It's not just taking a pill every day, it's actually being on a pump –connect to pump 24/7. So, so at least we're encouraged by the fact that that people are staying in the extension study.

[Peter Sehested:]

Thank you very much. Thank you.

[Operator:]

Thank you. Our next question is from the line of Jesper Ilsøe from Carnegie. Thank you. Please ask your question.

[Jesper Ilsøe:]

Just one question on news flow into 2021. So assuming the uneventful or there's, I hope, it happens but that glepaglutide is not pushed away too much into 2022. But assuming that glepaglutide is pushed into 2022, can just highlight what news flow to expect in 2021.

[Emmanuel Dulac:]

Yes. So, I mean, I think, probably take in the older. So the HypoPal PDUFA date is on March 27, 2021. We hope to you stay tuned for dapiglutide, the 7570 in 2021, we would as well initiate Phase 3 for the bi-hormone or dual hormone pumps in 2021. Hopefully we’ll get the results of dapiglutide in 2021. And potentially some others from -- that we haven't discussed yet, which is on the earlier pipeline. So, that's actually the full play.

[Adam Steensberg:]

And maybe I can just add, Phase 3 -- second Phase 3 in CHI, the small children, certainly where we expect a Phase 3 readout. And then, of course, you should expect updates on the Amylin program as well, I think that could be a very significant trade-in. And, yes, those that read some of the key…

[Emmanuel Dulac:]

Some of the major ones.

[Adam Steensberg:]

Major ones.

[Jesper Ilsøe:]

What can it do with the Amylin program, since you have it in house now?

[Adam Steensberg:]

Yes. But that’s -- that's with 2021 to know.

[Jesper Ilsøe:]

Okay. Thank you, guys.

[Emmanuel Dulac:]

Thank you.

[Operator:]

Seems like there are no further questions. Sir, please continued.

[Emmanuel Dulac:]

Well, then if there's no more questions then I just want to thank everyone for attending. And thank you for all your questions and listening.

[Operator:]

So that does include our conference for today. Thank you all for participating. You may all disconnect.