Zealand Pharma A/S

CSE:ZEAL

Earnings Call Transcript 2020-Q3

[Mads Kronborg, Head of Investor Relations & Communication]

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 U.S. 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.

[Emmanuel Dulac, CEO & President]

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 third quarter. We are preparing for our first commercial launch of the dasiglucagon and 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 assess while advancing the clinical development of our late-stage pipeline. Our organization has made significant progress in 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 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 glepaglutide, previously referred to as ZP7570. Glepaglutide is a long-acting GLP-1/GLP-2 dual agonist currently in development for short bowel syndrome. In the trial, glepaglutide, which sound 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 a 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 formula 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 the Head of Global Medical Affairs and Dr. Dave Campbell, as Senior Global Medical Adviser. Both doctors, Verge and Campbell, bring decades of experience in the global diabetes space. And we're 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 DKK 950 million to DKK 1 billion. 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 rescue pen 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, spanning positive clinical trial results and subsequent regulatory approvals. As you can see on Slide 4, Symphony data shows that the U.S. market for hypoglycemia rescue kit is a projected gross value of around $300 million. Already the new products introduced last year, following many years without meaningful innovation, accounts for around 40% of the market. Turning to Slide 5. And before I turn the call over to Matt to review financials in more detail, I would like to provide an update on the impacts we are seeing from COVID-19. Despite the progression of the pandemic and associated shutdowns and restricted health care measures, we have been able to preserve the majority of the time line 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 shown. 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 still -- 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 time lines that we have advanced for 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. And with that, I will hand it over to our CFO, Matt Dallas, to review financial results for the third quarter.

[Matthew Donald Dallas, Senior VP & CFO]

Thanks, Emmanuel. On Slide 6, you will see Zealand's income statement for the first 9 months of the year and how it compares to the same period in 2019. Total revenue for the first 9 months was DKK 290 million or USD 45.6 million. This was driven by net sales of V-Go, a Phase II milestone payment triggered in June from our partnership agreement with Boehringer Ingelheim and revenue recognition related to our collaboration with Alexion. The net operating result for the first 9 months was a loss of DKK 449.1 million or USD 70.6 million. Sales and marketing costs mainly related to the V-Go program required, as part of the Valeritas asset purchase agreement in April, while R&D costs mainly related 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 7 illustrates our strong financial position and ability to support our growing business through continued investments. Net operating expenses for the first 9 months of 2020 were DKK 714.5 million or USD 112.3 million. At the end of the third quarter of 2020, we had a cash position of DKK 1.53 billion or USD 240.4 million, funding the company through several key upcoming milestones. Turning to our financial guidance on Slide 8. 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 to DKK 170 million for the period in the period beginning on April 2, 2020, and ending on December 31. The net operating expenses in 2020 are expected to be within the range of DKK 950 million to DKK 1 billion. Financial guidance for net product revenue and operating expenses is unchanged to the financial -- 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.

[Adam Sinding Steensberg]

Thank you, Matt. So on Slide 9, you will see our robust pipeline of peptide drugs for metabolic and gastrointestinal diseases. And with the Phase III readout, the dasiglucagon CHI expected next month, I would like firstly to talk about the disease and our comprehensive Phase III program. So please turn to page -- Slide 10. So CHI is an ultra-rare disease, affecting around 1 in 25,000 to 50,000 newborns in the U.S. and EU 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 neuroma development. As you can imagine, CHI also greatly effects the patients, the parents and the relatives of the patients. And the current treatment options are limited and carries a high-risk 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 III program spanning children from age only 7 days to 12 years, which allows us to collect data across the patient from population. All participants offered continuation in our open-label extension study from which we will be collecting long-term data. To date, we had 29 out of 32 particulates in trial 17109 who have continued in the extension study. The second trial 17103 is ongoing, with 3 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 endpoints in trail 17109. To be included in the trial, the children had to be between 3 months and 12 years of age and experienced 3 or more events of hypoglycemia per week despite being a standard of care. When enrolled, the children were randomized to receive 8 weeks of dasiglucagon treatment as a subcutaneous infusion on top of standard of care or to continue 4 weeks of standard of care, followed by 4 weeks treatment with dasiglucagon. The primary endpoint is the number of hypoglycemic events measured in the last 2 weeks of the first 4-week treatment period. And key secondary endpoints will be to fasting tolerance, time in range for glucose and clinically significant hypoglycemic events. We are easily 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. Also depending on parenteral support, many patients are tied to infusion lines, limiting their ability to live a normal life, travel or single means at home. There is 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, and long-acting GLP-2 analog is being developed in an auto-injector with potential for convenient weekly administration. We are encouraged by the Phase II results, which showed increased intestinal absorption following only 3 weeks of treatment with a good safety profile. The pivotal Phase III trial seeks to establish efficacy and safety of once- and twice-weekly administration of glepaglutide with the primary endpoint to evaluate the reduction in weekly parenteral support volumes on 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 enrollments to decrease again in the last months. This means that while you may still see results in '21, timing of the data readout from the trial is currently uncertain. In addition to glepaglutide, we are developing glepaglutide, formerly referred to as a program named 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 SBS 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 trial with dapiglutide. The Phase Ia single-ascending dose trial safety -- which address 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 '21, 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.

[Emmanuel Dulac, CEO & President]

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 organizations progress to achieving our objectives in the first 9 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 programs 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 5 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?

[Operator]

[Operator Instructions] So our first question is from the line of Michael Novod from Nordea.

[Michael Novod]

It's Michael Novod from Nordea. A few questions. First of all, just a clarification on dasiglucagon in 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 glepaglutide, 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 2 prime questions.

[Adam Sinding Steensberg]

Thank you, Michael. And I think I will address both 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 file on only one study. As you also saw on the slide, it's actually a study where we covered the age span from 3 months to 12 years. And we have a very broad representation of different age groups in this study. And 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 1.5 years and some children. We would anticipate to engage in discussions with regulators and how we could file on that study alone and maybe supplement the studies from the smaller children. But again, we need to see the data and then make our plans on there. But correctly noted that is -- yes. And glepaglutide as we also recognize here, we are still working, as we have said all the time, very, very close with investigators, clinical side and regulators to see what we can do to address all the burden that the COVID situation has put on us. 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 time lines and so on. 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.

[Operator]

The next question is from the line of Graig Suvannavejh from Goldman Sachs.

[Graig Suvannavejh]

Congrats on the progress on the quarter. Just if I could ask 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 kind of get back 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?

[Emmanuel Dulac, CEO & President]

Graig, I think Adam will take this one again.

[Adam Sinding Steensberg]

Yes, 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. We have some sites that still have -- are still able sometimes closing down if we see a renewed spike and so on. Yes, U.K. has been extremely tough, I mean, hurt by the COVID situation, and we have had a continuous struggle on those sites. U.S. headed 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, and it's the same situation in Europe where we actually have sites, which can maintain activities and others who can't. So -- and that's why it's a very individual approach we have to each site. But for some time, we have -- I mean, you would also see that from other studies, even enrolling patients 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 seems to just be, you can say, technicality. We actually had to amend the studies and keep the pace in the main study until the site allowed patients to roll into new studies. So these are the logistical changes we have been dealing with and design investigators, and we have overcome them as we've also said before for all patients who are already randomized, we have also secured new randomizations, new screens throughout the period, but it's just much more struggle by the size for our CRO and so wanted to handle all this. So that slows down things a little bit. And then that is also -- has been among patients. Some -- we have had patients who have 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 neatly dialogues with all the drive side 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 weighted. The one thing we cannot compromise on is the quality. So we cannot just open up the study and the go of the quality aspects of the data connection 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 findings.

[Graig Suvannavejh]

Okay. That's helpful. And 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?

[Emmanuel Dulac, CEO & President]

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 launched the first product. It's the first launch for the Zealand Pharma. It's the first launch for dasiglucagon -- the first indication for the 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-COVID virus world. They are testing new platforms, digital platforms, engaging virtually with doctors. They are learning again, a new mass of the U.S. So some doctors use to see reps, and they don't see reps anymore. So we are actually getting a lot of insights 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 how will 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 rescue pen, V-Go is actually the product that the sales force is pushing.

[Graig Suvannavejh]

Okay. 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 to us to where we might then be able to learn on how some of those projects are progressing?

[Matthew Donald Dallas, Senior VP & CFO]

Yes. I think the one thing that we did highlight at this call and that was the progress we have made with glepaglutide, our GLP-1/GLP-2 Analog, which is in development also for short bowel syndrome. I think it -- 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 have multiple opportunities beyond SBS. So -- 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 with -- 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 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 is for an R&D day and late Q1 on that time.

[Operator]

Next question is from the line of Alan Carr from Needham & Co.

[Alan Carr, Senior Analyst]

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 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 math to do a Phase II in short bowel?

[Emmanuel Dulac, CEO & President]

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, do you want to put a sense.

[Adam Sinding Steensberg]

Yes. I think we alluded to that there are different opportunities with 7570 on 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 in GLP-1 and GLP 2 component, a super potent molecules. And yes, 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 is where we would share more on our thoughts 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, Senior Analyst]

Yes. I was just asking because it seems like it -- 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, you're not too far behind the first one. I was wondering how you were thinking about this strategically?

[Adam Sinding Steensberg]

That's a good point, and you can say that, of course, we would have to do our Phase II study with 7570 before we would understand the full differentiation potential with 7570 from what we have seen so far also in preclinical study and so on. It looks that it can provide those significant additional benefits also from the clinical setting of those combinations. But you are, of course, right, that is based on the Phase II data set, the depreciation is not such enough then it would perhaps not be so logical to procure 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, Senior Analyst]

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

[Emmanuel Dulac, CEO & President]

Our plan is to be launched ready at PDUFA date. So our teams will be there, fully staffed, trained. The launch -- 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 the -- this product produced printed and then the drug in the channels on February. So it takes a few more weeks. But the plan and what we can control, which is launch readiness. The plan is to be launched-ready at PDUFA date for the team.

[Operator]

The next question is from the line of Etzer Darout from Guggenheim.

[Etzer Darout, Senior Analyst]

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 glepaglutide based on the pharmacodynamic endpoints measured in the single-ascending dose study? And then I have a second question.

[Adam Sinding Steensberg]

Yes. There will be, but we actually do not have the full data on those yet. So that will be, again, at a later and probably something we will share at scientific conference.

[Etzer Darout, Senior Analyst]

Got it. And then on the dual-hormone pump program, the 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 time lines for the dual-hormone pump trial? And when we could see that data? And whether or not a 2023 launch for this program feasible?

[Adam Sinding Steensberg]

Yes. So it is, of course, a program that we have discussed before. We hope to see the Phase III starting this year, but then we're -- and [indiscernible] has communicated all the time, they wanted to initiate insulin-only and get the patients going and 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 time lines. And so we still are fully focused and plan to get going together these variance 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 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 that it's a 6-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 of [indiscernible] recruits the insulin-only study, which is a 440 patient study where they managed to ran -- to screen all patients in the couple of weeks or actually, I think, 6 weeks or so. And then it's a little bit longer to get dosing going and because there's a 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 and that the high-risk get tested in the insulin-only setting before we start with dual-hormone. So we have the opportunities just make small adjustments also to the protocol is the logistical learnings and so on. So we hope that we did earnings 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.

[Etzer Darout, Senior Analyst]

I think you said it before the sites and the patients are able to roll over.

[Adam Sinding Steensberg]

That's the span that the 440 patients should be able to roll into our study as well. So that would again add to speed of recruitment.

[Operator]

Next question is from the line of Lucy Codrington from Jefferies.

[Lucy-Emma Mary Sarah Codrington-Bartlett]

I only got a few left. Just -- firstly, just back on the artificial pancreas. I believe we have been expecting the insulin-only study to started doing during 3Q, and it now seems to have been pushed into 4Q. I'm assuming that, again, is related to COVID that with lockdowns increasing, is there a risk that, that could be delayed further? I do appreciate 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 its possibility to 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 a ramp with V-Go, and we're pressing for the dasi launch. Just looking into 2021, how should we be thinking about it relative to this year?

[Adam Sinding Steensberg]

Okay. If I just address the 2 first, and Emmanuel, you can address the sales and marketing question. But, second is on the insulin-only and the ability of data [indiscernible] dates and specifically to recruit patients with the huge base. What they have done is they've made, as you can say, updates to the protocol. So it's actively truly a remote study mean that they can do most of, if not all, on a remote basis, which means that they should not be impacted that's our understanding by the renewed products, and they have the patient already raised due to be randomizing dose. So what we see right now, we don't have any concerns with that, for that specific study. On data, as we 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 drive and withdraw, and we're 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 on here and so on with. So this is where -- that was our #1 focus after patient safety was to secure the quality of the data. So -- and that we believe we have done extremely well. So we -- and we have not lost patients on this. What I was referring to before it is just an example where we 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 have to stay only under 6 months in the main study. But those things, again, things we did in order to make sure we did not lose patients and maintain efficacy of the data set 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 tenders 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.

[Emmanuel Dulac, CEO & President]

Yes. 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.

[Operator]

The next question is from the line of Peter Sehested from Handelsbanken.

[Peter Sehested, Research Analyst]

As I have a couple. Phase Ib study, ZP7570 scheduled to end in June. How far that can you move into Phase II? And secondly, we previously talked about your expectations for ramp-up of HypoPal sales. And I think you indicate we should expect a, let's say, slow launch and with an acceleration after that. In that respect, are you sort of comfortable with the -- I mean, just a few numbers, but nonetheless, with the numbers that you can see, for instance, on Bloomberg, by consensus for around $100 million in sales of next year and then $270 million in the year thereafter. And then just finally, if you could just remind us about the patent expiry for that dasiglucagon?

[Adam Sinding Steensberg]

Okay. I can...

[Peter Sehested, Research Analyst]

No, sorry. Excuse me, sorry, Glepaglutide. Sorry, I was -- patent expiry for glepaglutide.

[Adam Sinding Steensberg]

Right. 7570, it's a multiple-ascending dose study. And as you can see in clinical trial set up currently retain with 3 doses -- 3 dose levels. So -- but you need to see the data before you end up being completely fair and when you can finalize the study, of course. We would be able to start Phase II study quite quickly after that. As you know, with Phase I study if 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 and our plans for that molecule. Paper, we have different patents protecting the glepaglutide, including formulations and so on. But the competition of meta patent has a date in '26 but then you will have to add up to 5 years extension based on what you can gain when you do to time we expand development. So that would likely take us into the '30 to mid-30s. So -- and then we -- as you know, we also have orphan drug designation in the U.S. for this molecule. Matt, do you want to take on this.

[Emmanuel Dulac, CEO & President]

Maybe very strong formulation patent as well.

[Adam Sinding Steensberg]

Exactly.

[Emmanuel Dulac, CEO & President]

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

[Matthew Donald Dallas, Senior VP & CFO]

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

[Peter Sehested, Research Analyst]

Again, just perhaps just a final one before I hop back into the queue. What should we see it as a clinically significant outcome in the CHI side?

[Adam Sinding Steensberg]

Yes. 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 3 events per week. If you have 9 and you reduce that to 5, that could be very significant. If you have 3, and you only reduce that by 1, I mean you still clinical significant. But I mean, we need to see the severity and have the full overview of that of the patients how and 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 ability to tolerance. We know for many patients and their caregivers, they have to wake up several times at night to feed the children to get to and take no 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 of, not only the patients, but the parents and caregivers. So with small study like this, 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, of course, assess the ability to reduce other standard of care treatment. And as I mentioned in my introductory notes, there's a lot of side effects with these things and they are -- many pay patients are being dosed far beyond what you should use of doses with these. So we can reduce that. That's another thing. So ultimately will be the quality of the data that will guide how attractive this treatment is. What encouraged us a lot is that so many patients have actually decided to stay on treatment in the extension study. And again, I just have to highlight, it's not just taking a poll every day, it's actually being on a pump -- connected to a pump 24/7. So at least, we're encouraged by the fact that people are staying in the extension study.

[Operator]

Our next question is from the line of Jesper Ilsoe from Carnegie.

[Jesper Ilsøe, Research Analyst]

Just one question on news flow into 2021. So assuming they are uneventful or the hope it happens, but that glepaglutide not pushed way too much into 2022. But assuming that glepaglutide is pushed into 2022, can you just highlight what news flow to expect in 2021?

[Emmanuel Dulac, CEO & President]

Yes. So I mean, I think let's try to take it in the order. So the HypoPal, PDUFA is on March 27, 2021. We hope to start Phase II for glepaglutide, 7570 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. The -- and potentially some others from -- that we haven't discussed yet, which is on the earlier pipeline. So that's actually a full plate.

[Adam Sinding Steensberg]

Maybe I can just add. Phase III -- second Phase III and CHI is more drilling, 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 very significant [indiscernible]. And yes, those are at least some of the key...

[Emmanuel Dulac, CEO & President]

Major ones.

[Adam Sinding Steensberg]

Major ones.

[Jesper Ilsøe, Research Analyst]

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

[Adam Sinding Steensberg]

Yes. But that's -- let's '21 to know.

[Operator]

It seems like there are no further questions. Please continue.

[Emmanuel Dulac, CEO & President]

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.