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 kroner. 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 our CEO, Emmanuel Dulac.
Thank you, Mads, and thanks to everyone for joining today. As the world is weathering its eighth month of the COVID-19 pandemic, at Zealand Pharma, we continue to advance on our plans and commitments during a strong, strong third quarter. We are preparing for our first commercial launch of the Dasiglucagon HypoPal, for which we expect to receive notification on U.S. FDA approval in March. We also continue to leverage our innovative peptide platform for early assets 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 clinical and regulatory milestones, which will support our mission of transforming patients' lives through peptide innovations and novel treatment solutions.
On the clinical front, we are excited to share the news of completion of a phase IA 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, clinical operations immediately started dosing the first participants in a phase IB multiple ascending dose trial. This dual agonist program is the first attempt to advance the combination therapy for SBS patients, which we believe could represent the next generation of treatments. We also see progress in our late-stage pipeline, including Dasiglucagon in congenital hyperinsulinism. Patient enrollment in the Phase III trial is complete, and we expect to report top-line data in December.
CHI is an area with huge unmet medical needs, which is also reflected in the fact that both the FDA and the European Commission granted orphan drug designation to dasiglucagon in this indication. We are hopeful that dasiglucagon can transform the treatment of this debilitating disease. I am also especially proud of the amazing work by our Zealand Pharma team and their ongoing efforts to recruit the best talents from around the world. Together, we recently augmented our global medical affairs function with the addition of Dr. Danilo Verge as Head of Global Medical Affairs and Dr. David Kendall as Senior Global Medical Advisor. Both doctors, Verge and Kendall, bring decades of experience in the global diabetes space, and we are delighted to have them on board and look forward to continuing to benefit from their expertise.
Our financials remain strong, and we continue to invest significantly in research and development and advance our commercial organization in the United States. We maintain our financial guidance, expecting net operating expenses for the full year of 2020 of 950 million-1 billion DKK. As for our commercial progress, we continue to build out our commercial organization in the U.S. to both support the marketing and sales of the V-Go wearable insulin delivery device and to prepare for the HypoPal launch. We have now a robust commercial infrastructure in place and are taking steps for the launch of HypoPal as we await a decision on regulatory approval from the FDA, which is set for March 27, 2021.
If approved, HypoPal will be our first commercial launch as a company and the first for dasiglucagon, which we hope will set the stage for future dasiglucagon launches in additional metabolic indications, including CHI, diabetes management, and post-bariatric hypoglycemia, all, of course, pending positive clinical trial results and subsequent regulatory approvals. As you can see on slide four, Symphony Health data shows that the US market for hypoglycemia rescue kits is a projected gross value of around $300 million. Already, the new products introduced last year, following many years without meaningful innovation, account for around 40% of the market. Turning to slide five, and before I turn the call over to Matt to review financials in more detail, I would like to provide an update on the impact we are seeing from COVID-19.
Despite the progression of the pandemic and associated shutdowns and restrictive healthcare measures, we have been able to preserve the majority of the timeline for our R&D programs through the incredibly hard work and determination of our team. One exception, however, is the impact the pandemic has had on the phase III trial of glepaglutide in Short Bowel Syndrome, where new patient inclusion and study progress is slow. Our CMO, Adam Steensberg, will talk more about the pandemic impact on our clinical trials and the steps we're taking to mitigate this. While we may still see the top-line results in 2021, we will need to see enrollment numbers over the next couple of months before we can provide a specific time frame to complete the study.
We are confident in the current timelines that we have advanced for our other ongoing clinical programs, including the initiation of a phase III trial for dasiglucagon in a bi-hormonal artificial pancreas pump in 2021. Overall, I am proud of the way we have kept our company, labs, and operations running despite the unprecedented global challenges. With that, I will hand it over to our CFO, Matt Dallas, to review financial results for the third quarter.
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 290 million DKK, or $45.6 million. This was driven by net sales of V-Go, a phase II 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 449.1 million DKK, or $70.6 million.
Sales and marketing costs mainly relate to the V-Go program acquired as part of the Valeritas asset purchase agreement in April, while R&D costs mainly relate to the regulatory efforts to support the NDA filing for the HypoPal rescue pen, as well as clinical development of dasiglucagon and HypoPal supplement 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 $112.3 million. At the end of the third quarter of 2020, we had a cash position of DKK 1.53 billion, or $240.4 million, funding the company through several key upcoming milestones. Turning to our financial guidance on slide eight, in 2020, we expect revenue from existing license agreements.
However, since such revenue is uncertain in terms of size and timing, we do not intend to provide guidance on such revenue. Net product revenue from the sales of V-Go is expected to be within the range of DKK 150 million-DKK 170 million for the period, and the period beginning on April 2, 2020, and ending on December 31. Net operating expenses in 2020 are expected to be within the range of DKK 950 million-DKK 1 billion. Financial guidance for net product revenue and operating expenses is unchanged to the operating guidance announced on August 13, 2020. I will now turn the call over to our Chief Medical Officer and Head of R&D, Adam Steensberg, to discuss highlights from our pipeline.
Thank you, Matt. On slide nine, you will see our robust pipeline of peptide drugs for metabolic and gastrointestinal diseases. With the phase III readout for Dasiglucagon and CHI expected next month, I would like firstly to talk about the disease and our comprehensive phase III program. Please turn to slide 10. 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 neuronal development. As you can imagine, CHI also greatly affects the parents and the relatives of the patients. The current treatment options are limited and carry 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, where you can see the comprehensive phase III program spanning children from age only seven days to 12 years, which allows us to collect data across the patient population. All participants are offered 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, 17103, is ongoing, with three children having completed the trial and also entered the long-term extension study. The expected phase II readout for the latter is 2021. On slide 12, you will see the design and the key endpoints in trial 17109.
To be included in the trial, the children had to be between three months and 12 years of age and experience three or more events of hypoglycemia per week despite being on standard of care. When enrolled, the children were randomized to receive eight weeks of dasiglucagon treatment as a subcutaneous infusion on top of standard of care or to continue four weeks of standard of care followed by four weeks' treatment with dasiglucagon. The primary endpoint is the number of hypoglycemic events measured in the last two weeks of the first four-week treatment period, and key secondary endpoints look into fasting tolerance, time and range for glucose, and clinically significant hypoglycemic events. We are eagerly anticipating the top-line data from the study in December. In case of a positive outcome, we plan to pursue a dialogue with regulatory authorities about a potential filing for registration.
So turning to our clinical programs in short bowel syndrome on page 13, SBS is a severe disease with a massive impact on patients' health and quality of life. Often depending on parenteral support, many patients are tied to infusion lines, limiting their ability to live a normal life, travel, or simply leave their home. There's a serious unmet medical need for better and more reliable treatments that will reduce the parenteral support needs. And at Zealand, we have for many years been committed to improving treatments for patients with SBS. Our lead candidate in this program, glepaglutide, a long-acting GLP-2 analog, is being developed in an autoinjector with potential for convenient weekly administration. We are encouraged by the phase II results, which showed increased intestinal absorption following only three weeks of treatment with a good safety profile.
The pivotal phase III trial seeks to establish the efficacy and safety of once- and twice-weekly administration of glepaglutide, with a primary endpoint to evaluate the reduction in weekly parenteral support volumes from baseline to week 24. As mentioned, enrollment of new patients was impaired in the second quarter this year. And while we observed increased activity over the summer, the renewed spikes in COVID-19 have caused enrollment to decrease again in the last months. This means that while you may still see results in 2021, timing of the data readout from the trial is currently uncertain. In addition to glepaglutide, we are developing dapiglutide, formerly referred to as a program name ZP7570. Dapiglutide is a potential first-in-class and long-acting GLP-1 and GLP-2 receptor agonist currently advancing for the development of improved management of SBS beyond what can be achieved with a mono GLP-2 treatment.
It may represent the next level of innovation in helping SDS patients to further realize the full potential for intestinal rehabilitation. Please move to slide 14, where you will see an overview of our phase I trials with Dapiglutide. The phase IA single ascending dose trial, which addressed safety and tolerability in healthy volunteers, was completed in the third quarter, and the product was found to be safe and well tolerated in the trial, and we observed the plasma half-life allowing for weekly dosing. We are very encouraged to announce that based on the positive phase I data, we immediately initiated the phase IB multiple ascending dose safety and tolerability trial and even managed to dose the first patients in this study here in early November. Results from the trial are expected in 2021, at which point we also expect to provide updates on the next development steps.
With that, I will now turn the call to Emmanuel for his closing remarks.
Thank you, Adam, 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 ingenuity. 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 on the market by 2025. Every day, we work towards fulfilling the significant potential of Zealand and realizing our ambition of transforming patient lives.
With that, we're now ready to take your questions. Operator.
Thank you. Ladies and gentlemen, we will now begin the question and answer session. Again, as a reminder, if you wish to ask a question, please press star one on your telephone and wait for a name to be announced. And if you wish to cancel your request, please press the hash key. Once again, star one should you wish to ask a question. Okay, so our first question is from the line of Michael Novod from Nordea. Thank you. Please ask your question.
Thank you very much. Yes, it's Michael Novod from Nordea in Copenhagen. A few questions. First of all, just a clarification on Dasiglucagon and CHI. So you previously noted that you would file when you saw the readout of the second trial. 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 and see whether you can file on this first trial. Just a clarification on that. And then secondly, on Dapiglutide, if you do see substantial delays to further enrollment, do you have or do you see ways where you can do an analysis on the patients that have already been enrolled and treated, or do you have to complete with full enrollment of the trial and hence just get past the potential delays? Those were the two prime questions. Thank you.
Thank you, Michael. And I think I will address both questions. So if we start with CHI first, it is correct that once we see the data, we will evaluate the opportunity to potentially file on only one study. As you also saw on the slide, it's actually a study where we cover the age span from three months to 12 years. And we have a very, very broad representation of different age groups in this study.
Since we are 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 allowing us to collect actually safety data for more than one and a half years in some children, we would anticipate to engage in discussions with regulators and how we could file on that study alone and maybe supplement the study from the smaller children. Again, we need to see the data and then make our plans from there. Correctly noted, that is, yeah. On Glepaglutide, as you also recognize here, we are still working, as we have said all the time, very, very close with investigators, clinical sites, and regulators to see what we can do to address all the burden that the COVID situation has put on the centers.
The key point for us is, of course, first of all, to secure patient safety in these studies, which we have very good control of, and then the quality of the data and trial integrity. I mean, it is a phase III study, and we cannot compromise on getting the right quality. With regard to other measures we could take to potentially accelerate timelines and so on, we are exploring all options, and what we can say is, as we know more about when we will have results, we will inform the market.
Thank you.
Thank you. The next question is from the line of Graig Suvannavejh from Goldman Sachs. Thank you. Please answer your question. So Graig, your line is now open. Please go ahead.
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, 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 can you do to kind of get that to a place in terms of enrollment speed where you're more comfortable? Or is it simply we just have to wait until COVID goes away and you can get enrollment back up to where it needs to be?
Yeah, Graig, I think Adam will take this one again.
It's a good question, and I think it's actually a combination, and it's a little bit the same picture as we have discussed before. Some sites are still able, some sites are closing down if we see a renewed spike and so on. The reality is the U.K. has been extremely tough. I mean, hurt by the COVID situation, and we have had a continuous struggle in those sites. The U.S. tended to open up, and we are still seeing some sites, actually a number of sites, which are very active and others who are more careful. It's the same situation in Denmark and in Europe, where we actually have sites which can maintain activities and others who can't, and that's why it's a very individual approach we have to each site.
But for some time, I mean, you would also see that from other studies, even enrolling patients over from the pivotal part of the study to the extension part. We were not able to do that because the local ethical committees and so on saw that as a new study, meaning that what seemed to just be, you can say, a technicality, we actually had to amend the studies and keep the patients in the main study until the site allowed patients to roll into new studies. So these are the logistical challenges we have been dealing with and the site investigators. And we have overcome them, as we've also said before, for all patients who are already randomized. We've also secured new randomizations, new screenings throughout the period, but it's just much more struggle by the sites, for our CRO and so on to handle all this.
So that slows down things a little bit. And then there is also, there has been among patients, some we have heard patients who had been willing to come into the site but just said, "Well, we would like 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, you can say, 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. The 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 if it is to serve a regulatory finding.
Okay, that'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, well, 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?
That's a good question. That's a question that our US 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 launch the first product. It's the first launch for Zealand Pharma. It's the first launch for Dasiglucagon, the first indication for Dasiglucagon. So it is really important for us to actually do the best we can on this one. As you know, it's not a very large indication as well, the rescue market, but it is actually symbolic 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 facing reality.
So they are actually engaging with payers, facing the new post-coronavirus world. They are testing new platforms, digital platforms, engaging virtually with doctors. They are learning, again, a new map of the U.S. So 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 our resource. But that's where we are still doing the assessment of how will we prioritize resources. Right now, V-Go is the only product that they have in their hands. So until we get the positive approval for HypoPal, V-Go is actually the product that the salesforce is pushing.
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 nFow 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.
Yeah, I think the one thing that we did highlight at this call, and that was the progress we have made with Dapiglutide, our GLP-2, GLP-2 analog, 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 IA in Q3 and then also start the multiple ascending dose. It's actually a program that has multiple opportunities beyond SDS. 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, I would say by the end of Q1 or in that area, that is probably where you should expect us to provide a more 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 on 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 is for an R&D day and perhaps late Q1 at that time.
Yeah. Okay, thank you.
Next question is from the line of Alan Carr from Needham & Company. Thank you. Please ask your question.
Hi, thanks for taking my questions. I want to talk about preparations for HypoPal from a CMC perspective. Any risks around that? 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 ZP7570, is your plan to go straight to short bowel syndrome? You hinted at other indications, but is the plan after you finish the MAD to do the phase II and short bowel? Thanks.
Yeah. So we're going CMC, and as you know, in the FDA reviews, this is one of the areas 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 ZP 7570, maybe Adam, you want to put your stance?
I did tell you today too that there are different opportunities with 75/70 on the indication. But for sure, when we talk about SDS, what we have seen also on preclinical models and from the GLP-1 and GLP-2 combination studies that have been conducted by other investigators, it has a high potential in SDS. 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 another indication beyond SDS. Both the GLP- 1 and the GLP- 2 components are super potent molecules. And yeah, you can come up with a number of indications where this could actually be a benefit. So again, potentially at the R&D day next year, it's where we will share more on our thoughts on what we do with 75/70.
At that time, we will also progress further into the multiple ascending dose study. It is clearly a priority program for Zealand.
Yeah, I was just asking because it seems like with the phase III for Glepaglutide carrying on, I wondered if there was enough of a, when you think about the next drug coming along for SBS, not too far behind the first one. I just wondered how you were thinking about this strategically.
No, but that's a good point. And you can say that, of course, we would have to do our phase II study with 75/70 before we would understand the full differentiation potential with 75/70. From what we have seen so far, also in preclinical study and so on, it looks that it can provide very significant additional benefits also from the clinical testing of loose combinations. But you are, of course, right that if based on the phase II dataset, the differentiation is not large enough, then it would perhaps not be so logical to pursue an SDS. But that's also why we are excited about other opportunities, which we look forward to discuss more once we have them defined a little bit more.
Sure. And then to clarify the time for HypoPal launch, would you be ready to go right after the Beta date, or would there be a lag by weeks or months?
Our plan is to be launch ready at PDUFA date. So our teams will be there, fully staffed, trained. The effective launch, as you know, is taking a few more weeks to, because you get the label basically on PDUFA date. So we need to get this product produced, printed, and then the drug in the channels, on primary. So it takes a few more weeks. But the plan and what we can control, which is launch readiness, the plan is to be launch ready at PDUFA date for the teams.
Great. Thanks for taking my questions.
Thank you. The next question is from the line of Etzer Darout from Guggenheim. Thank you. Please answer your question.
Thanks for taking questions. First one, I guess, is another follow-up to ZP7570. Just wondered if there are any comparisons you can make thus far on biomarkers of disease between ZP7570 and glepaglutide based on the pharmacodynamic endpoints you measured in the single ascending dose study. And then I have a second question.
Yeah, there will be, but we actually do not have the full dataset on those yet. So that will be, again, at a later and probably something we will share at the scientific conference.
Got it. And then on the dual hormone pump program, if first patient is dosed as planned in the insulin-only trial in the fourth quarter, I 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 data and whether or not a 2023 launch for this program is feasible?
Yeah, so it is a closed program, as we have discussed before. We had hoped to see the phase III starting this year, but then there were, and as Beta Bionics has communicated all the time, they wanted to initiate the insulin-only and get the patients going in that before they start our study. So it has moved into next year, but as Emmanuel also shared in the start, we are very confident in those timelines. And so we still are fully focused and plan to get going together with Beta Bionics on the phase III study next year. At that time, we should also have completed our interactions with FDA on the end of phase II meetings and so on. Those we will have in the coming months. We're anticipating 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-month study, so that kind of defines the time once we have the last patient in, so it will be hugely interesting to see the speed with which PDUFA can actually recruit to the insulin-only study, which is a 440-patient study where they managed to screen all patients in a couple of weeks or actually, I think, six weeks or so, and then it took a little bit longer to get dosing going 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 once we start the phase III with the dual hormone.
I think the other aspect that we keep highlighting is that it's actually a very good scenario to be in that they either get tested in the insulin-only setting before we start our dual hormone so they have the opportunity to just make small adjustments also to the protocol with their logistical 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, we will be able to maintain speed once we get to the dual hormone.
I think you said it before, the sites and the patients are able to roll around.
That's the plan that the 440 patients should be able to roll into our study as well. That would, again, add to speed of recruitment.
Right. Got it. Thank you.
Next question is from the line of Lucy Codrington from Jefferies. Thank you. Please ask your question.
Thank you for taking my questions. I've only got a few left. Just back on the artificial pancreas, I believe we had been expecting the insulin-only study to start with 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, just to confirm, 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 in one Q, it was around 50%. I wonder if we've made much progress since then.
Then thirdly, regarding sales and marketing, obviously, there's been the ramp with V-Go, and we're prepping for the dasiglucagon launch. Just looking into 2021, how should we be thinking about it relative to this year? Thank you.
If I just address the two first, and I guess Emmanuel, you can address the sales and marketing first. But on the insulin-only and the ability of Beta Bionics and the iLet system specifically to recruit patients with the new types, what they have done is they have made, you can say, updates to the protocol. So it's actually truly a remote study, meaning 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 renewed spikes, and they have the patients already ready to be randomized and dosed. So what we see right now, we don't have any concerns with that for that specific study.
On glepaglutide, as you have said before, and this is also the case still, that for all the patients who were screened or randomized or were in the study, we were able to continue to provide them with drugs. We were also able to continue to provide, you can say, secure data quality, making sure that we get the right measures in to base our adjustments and PS and so on with. So this is where we have. That was why our number one focus after patient safety was to secure the quality of the data. We believe that we have done extremely well. We have not lost patients on these screenings.
That's right.
What I was referring to before is there's an example where they had to amend the main study to keep some patients in the study because specific sites would not allow them to roll into the extension study. And so they had to stay beyond the six months in the main study. But those things, again, things we did in order to make sure we did not lose patients and maintain the integrity of the dataset and so on. So we don't see anything there. We do not comment on specific numbers on recruitment, but we are beyond halfway in the study, which we appreciate. And we have still around 39 centers active in the study. So we feel we are on a good trajectory, but we also know that it's going to be hard work.
Yeah. 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.
Okay. Thank you.
Thank you.
The next question is from the line of Peter Sehested from Handelsbanken. Thank you. Please answer your question.
As Peter from Handelsbanken has taken my question, I have a couple. phase IB study, ZP7570, scheduled to end in June. How far up that can you move into phase II? And secondly, we've previously talked about your expectations for ramp-up of HypoPal sales. And I think you indicated that we should expect a slow launch and then with an acceleration after that. In that respect, are you sort of comfortable with the—I mean, it's just a few numbers, but nevertheless, with the numbers that you can see, for instance, on Bloomberg, right, consensus for around 100 million sales of next year and then 270 in the year thereafter. And just finally, if you could just remind us about the patent expiry for Glepaglutide.
Okay. I can...
No, sorry. Excuse me. Sorry. Glepaglutide. Sorry. I was yeah.
Okay.
Patent expiration for Glepaglutide.
Right. 7570 is a multiple ascending dose study. And as you can see in clinical trials, we are currently within the three dose levels. But you'll 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 II study quite quickly after that. As you know, with Phase I study, you have access to data on a rolling 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 provide more updates early next year on our plans for that molecule. Glepaglutide, we have different patents protecting Glepaglutide, including formulations and so on.
But the composition-of-matter patent has a date in 2026, but then you will have to add up to five years extension based on what you can gain when you do some time with pending development. So that would likely take us into the early to mid-2030s. And then, as you know, we also have orphan drug designation in the U.S. for this molecule. Do you want to take next?
And then there are strong formulation patents as well.
Exactly.
Yeah, and then for the HypoPal, yeah, the math, you should take it.
Yeah. On the HypoPal, we have not issued guidance, nor will we be issuing guidance in the near term. We haven't gotten the PDUFA dates. It's still a number of months away. So not until we get through that point and then more commercial plans are outlined will we start kind of focusing on near short-term revenue expectations around the launch of that.
Okay. Thank you. Just a final one before I pop back into the queue. What should we see as a clinically significant outcome in the CHI study? Thank you.
Yeah. I will actually wait to comment on that because, of course, it depends on 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, it's still clinically significant. But I mean, we need to see the severity and have the full overview of that of the patients 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 is the ability to fast.
We know for many patients and their caregivers, they have to wake up several times a night to feed the children, to get the intestinal tubes and so on because they cannot tolerate fasting, so if you can expand that one as well, that is one that will have a major impact on the quality of life, not only the patients but the parents and caregivers, so with small studies like this, it's 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, of course, assess the ability to reduce other standard of care treatments, and as I mentioned in my introductory notes, there's a lot of side effects with these things.
Many patients are being dosed far beyond what you should use of doses with these. If we can reduce that, that's another thing. Ultimately, it will be the totality of the data that will guide how attractive this treatment is. What encourages us a lot is that so many patients have actually decided to stay on treatment in the extension study. Again, I just have to highlight, it's not just taking a pill every day. It's actually being on a pump, connected to a pump 24/7. At least we are encouraged by the fact that people are staying in the extension study.
Okay. Thank you very much.
Thank you. Our next question is from the line of Jesper Ilsøe from Carnegie. Thank you. Please ask your question.
Just one question on new flow into 2021, so assuming the uneventful - or I hope it happens - but that Glepaglutide is not pushed way too much into 2022, but assuming that Glepaglutide is pushed into 2022, can you just highlight what new flow to expect in 2021?
Yeah. So I mean, I think let's try to take it in the order. So the HypoPal, the PDUFA date is on March 27, 2021. We hope to start phase II for Dapiglutide, the ZP7570, in 2021. We would as well initiate phase III for the bi-hormonal or dual hormone pump in 2021. Hopefully, get the results of Glepaglutide in 2021. And potentially some others that we haven't discussed yet, which is on the earlier pipeline. So that's actually a full plate.
Maybe I can just add phase III, second phase III on CHI, the small children. Starting where we expect to have phase III readout, and then, of course, you should expect updates on the Amylin program as well. I think that could be a very significant trigger, and yeah, those are at least some of the key major ones.
What can you do with the Amylin program since you have it in-house now?
Yeah. But that's for 2021 to know.
Okay. Thank you, guys.
Thank you.
It seems like there are no further questions, so please continue.
If there's no more questions, then I just want to thank everyone for attending. Thank you for all your questions and listening.