Zealand Pharma A/S (ZEAL) Q3 2020 Earnings Call Transcript

Logo of jester cap with thought bubble.

Image source: The Motley Fool.

Zealand Pharma A/S (NASDAQ:ZEAL)
Q3 2020 Earnings Call
Nov 12, 2020, 10:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by and welcome to the Zealand Pharma’s Results for Q3 2020. [Operator Instructions] Also I must advise that the call is being recorded today, Thursday 12th, 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 KronborgHead of Investor Relations and Communication

Thank you, operator. Welcome and thank you for joining us today to discuss Zealand’s third quarter 220 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 krones 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.

Emmanuel DulacPresident and Chief Executive Officer

Thank you, Mads. And thanks to everyone for joining today. As the world is weathering its eight months 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 rescue pen for which we expect to receive notification on the US 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 peptide innovations and novel treatment solutions.

On the clinical front, we are excited to share the news of completion of the phase Ia single ascending dose trial with dapiglutide, previously referred to as ZP7570. Dapiglutide is a long-acting GLP1/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 corporations 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 DKK950 million to DKK1 billion.

As for our commercial progress, we continue to build out our commercial organization in the US 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 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 4, Symphony data shows that the US market for hypoglycemia rescue kits is a projected growth 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 COVD-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 R&D programs through the incredibly hard work and determination of our team. One exception, however, is impact the pandemic has had on the Phase III trial of glepaglutide in short bowel syndrome where new patients inclusion and steady progress is slow. Our CMO, Adam Steensberg will talk more about the pandemic impact on our clinical trial and the steps we’re taking to mitigate these.

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 timelines 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.

Matt DallasSenior Vice President and Chief Financial Officer

Thanks, Emmanuel. On Slide 6, 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 DKK290 million 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 DKK449.1 million or $70.6 million. Sales and marketing costs mainly related to the V-Go program acquired 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 pre-clinical 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 nine months of 2020 were DKK714.5 million or $112.3 million. At the end of the third quarter of 2020, we had a cash position of DKK1.53 billion or $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 the 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 DKK150 million to DKK170 million for the period in the period beginning on April 2, 2020 and ending on December 31st.

Net operating expenses in 2020 are expected to be within the range of DKK950 million to DKK1 billion. Financial guidance for net product revenue and operating expenses is unchanged to the operating guidance announced on August 30th, 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 SteensbergExecutive Vice President, Research and Development, and Chief Medical Officer

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 readouts of dasiglucagon in CHI expected next month, I would like firstly to talk about the disease and our comprehensive Phase III program. So please turn to page or Slide 10. So CHI is an ultra-rare disease affecting around one 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 neuronal development. As you can imagine, CHI also greatly affects the patients’ 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 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 a continuation in our own label extension study from which we will be collecting long-term data. To date, we had 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 in the long-term extension study. The expected data 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 experienced three or more events of hypoglycemia per week despite being on standard of care. We’ve enrolled the children we 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 in range for glucose, and clinically significant hypoglycemic events. We are eagerly anticipating the top line data from this study in December. In case of the positive outcome, we plan to pursue a dialog 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 parental 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 parental 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 delivered 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 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 the primary endpoint to evaluate the reduction in weekly parental 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 we may still see results in ’21, 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 named ZP7570. Dapiglutide is a potential first-in-class and long-acting GLP-1 and GLP-2 receptor agonist currently advancing for the development for improved management of SBS beyond what could be achieved with a mono GLP-2 treatment. It may present 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 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 ’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 DulacPresident and Chief Executive Officer

Thank you, Adam and thank you, Matt. Please turn to Slide 15. 2020 has been a significant year for Zealand and 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 having five products on the market by 2025. Every day, we work toward 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?

Questions and Answers:

Operator

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

Michael NovodNordea — Analyst

Thank you very much. It’s Michael Novod from Nordea in Copenhagen. A few questions, first of all, just a clarification on dasiglucagon in CHI. So you’ve 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 two important questions. Thank you.

Adam SteensbergExecutive Vice President, Research and Development, and Chief Medical Officer

Thank you, Michael and I think I will address both questions. So if we start with CHI first, it is actually — it is correct that once we see the data, we will evaluate the opportunity to potentially file an only one study as you also saw on the slide, it’s actually a study where we cover the age band from three months to 12 years and we have a varied [Phonetic] growth representation of different age groups in the study and since we are talking about an ultra rare indication and actually a rather large study of 32 children and also highlighting a number the children we have in the extension study allowing us to collect actually safety data for more than 1.5 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 maybe advance from there. But 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 side and regulators to see what we can do to address all the burden that 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.

Michael NovodNordea — Analyst

Thank you.

Operator

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

Graig C. SuvannavejhGoldman, Sachs & Co. — Analyst

Yes. Thank you very much. Sorry about that. Good afternoon, good morning everyone and thanks for taking my questions and congrats on the progress in 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 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?

Emmanuel DulacPresident and Chief Executive Officer

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

Adam SteensbergExecutive Vice President, Research and Development, and Chief Medical Officer

Yeah. 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. Some sites still have — are still able, some sites are closing down as we see a renewed spike 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 sites. US 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 we — it’s a very individual approach we have to each site. But for some sites we have a — I mean you would also see that from other studies, even enrolling patients from the pivotal part of the study to the extension part was 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 a, you can say, technicality, we actually had to amend 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 and the site investigators and we have overcome them.

As we’ve also said we go for all patients who are already randomized, we’ve also secured new randomized patients, new screenings throughout the period. But it’s just much more struggle by the sites [Indecipherable] to handle all of 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 have been willing to come into the dasiglucagon [Phonetic] 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 why we are handling the situation on so many levels, I would say. But we are, we can say, almost in weekly dialogs 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 a 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. It’s a level where we have good quality data to serve regulatory filing.

Graig C. SuvannavejhGoldman, Sachs & Co. — Analyst

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, 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-a-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 DulacPresident and Chief Executive Officer

Right. 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 a first launch for Zealand Pharma. It’s the first launch for dasiglucagon — the first indictiaon 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-covirus [Phonetic] world. They are testing new platforms, digital platforms engaging virtually with doctors, they are learning, again a new map of the US. 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 positive approval from — for HypoPal rescue pen, V-Go is actually a weak product that the sales force is pushing.

Graig C. SuvannavejhGoldman, Sachs & Co. — Analyst

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 DulacPresident and Chief Executive Officer

Yeah. I think the one thing that we did highlight at this call and at what’s 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 Ia 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 where 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 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.

Adam SteensbergExecutive Vice President, Research and Development, and Chief Medical Officer

Yeah.

Graig C. SuvannavejhGoldman, Sachs & Co. — Analyst

Okay. Thank you.

Operator

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

Alan CarrNeedham — Analyst

Hi. Thanks for taking my questions. I want to talk about preparations for HypoPal from a CMC perspective. 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 the finish the MAD [Phonetic] to do the Phase II in short bowel? Thanks.

Emmanuel DulacPresident and Chief Executive Officer

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 expand?

Adam SteensbergExecutive Vice President, Research and Development, and Chief Medical Officer

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 the 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 at the R&D day next year, it’s 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 CarrNeedham — Analyst

Yeah, 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 SteensbergExecutive Vice President, Research and Development, and Chief Medical Officer

That’s a good point, Alan, and you can say that, of course, you 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 increasing on the 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 it is based on the Phase II data set, the depreciation is not [Technical Issues] and it would perhaps not 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 CarrNeedham — 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 DulacPresident and Chief Executive Officer

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, it’s taking few more weeks to — because you get the label basically on PDUFA date. So, we need to get this product produced, printed, and then there’s drug in the channels on formularies. so it takes a few more weeks, but the plan what we can control, which is launch readiness, the plan is to be launch ready at PDUFA date for the team.

Alan CarrNeedham — Analyst

Great, thanks for taking my questions.

Operator

Thank you. The next question is from the line of Etzer Darout from Guggenheim. Thank you, please ask your question.

Etzer DaroutGuggenheim — Analyst

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.

Emmanuel DulacPresident and Chief Executive Officer

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

Etzer DaroutGuggenheim — Analyst

Got it. And then on the dual hormone pump program, if the first patient is dosed as planned in the insulin only trial in the 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 data and whether or not a 2023 launch for this program feasible?

Adam SteensbergExecutive Vice President, Research and Development, and Chief Medical Officer

Yeah, so it is of course a program that we have discussed before. We had hoped to see the Phase III starting this year, but then we’re and as state department has communicated all the time, they wanted the insulin-only and get the patients going in dasiglucagon at 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 the blinds [Phonetic] on the Phase III study next year.

At that time, we should also have completed our interactions with the 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, but 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 six months study. So that kind of defines the time once you have a patient in. So it will be hugely interesting to see the speed with which [Indecipherable] recruits the insulin-only study, which is a 440-patient study where they managed to ramp, to screen all patients in a couple of weeks or actually I think six weeks or so and then it’s 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 once we start the Phase III with the dual hormone. I think the other aspects that we keep highlighting is that it’s actually a very good scenario to be in that the eyelids [Phonetic] 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 if there are logistical learnings and so on. So we hope that we’ll take 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.

Emmanuel DulacPresident and Chief Executive Officer

I think you said it before the sites and the patients are able to —

Adam SteensbergExecutive Vice President, Research and Development, and Chief Medical Officer

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

Etzer DaroutGuggenheim — Analyst

Got it. Thank you.

Operator

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

Lucy CodringtonJefferies — Analyst

Thank you for taking my questions. I only got a few left. 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 that with the lock down increasing, is there a risk that, that could be delayed further. I do appreciate that 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 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, just looking into 2021, how should we be thinking about it relative to this year? Thank you.

Adam SteensbergExecutive Vice President, Research and Development, and Chief Medical Officer

If I just address the two first and I guess, Emmanuel, you can address the sales and marketing question, but on the insulin-only [Indecipherable] and specifically to recruit patients with the new sites, what they have done is they have made you can say updates to the protocol, so exactly truly a remote setting means 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 patients already registered to randomized to those. So what we see right now we don’t have any concerns with that, but that’s specific study.

On glepaglutide as we have said before and this is also the case still that for all the patients who were screened or randomized in the world in this study, we were able to continue to provide them the drug and we were also 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 fears and so on.

So this is where we have — that was our number one focus after patient safety, we want to secure the quality of the data and that we believe we have done extremely well. So we have — and we have not lost patients and [Indecipherable]

What I was referring to before 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 patients and maintain the integrity of the data set and so on.

So we don’t see anything that — we do not 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 DallasSenior Vice President and Chief Financial Officer

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.

Lucy CodringtonJefferies — Analyst

Okay. Thank you.

Adam SteensbergExecutive Vice President, Research and Development, and Chief Medical Officer

Thank you.

Operator

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

Peter SehestedHandelsbanken — Analyst

It’s Peter from Handelsbanken. Thank you for taking my question. I have a couple. Phase Ib study and ZP7570 scheduled to end in June, how far can you move into Phase II? And secondly, we’ve previously talked about your expectations for ramp up of HypoPal sales. I think you indicated that we should expect a slow launch and an acceleration after that. In that respect, are you sort of comfortable with the, I mean, just a few numbers but nevertheless, with the numbers that you can see for instance on Bloomberg, a consensus of around DKK100 million sales of next year, and then DKK270 million in the year thereafter?

And then just finally, if you could just remind us about the patent expiry for dasiglucagon?

Emmanuel DulacPresident and Chief Executive Officer

Okay.

Peter SehestedHandelsbanken — Analyst

Oh, sorry. Excuse me. Sorry, glepaglutide, sorry. Yeah.

Emmanuel DulacPresident and Chief Executive Officer

Okay.

Peter SehestedHandelsbanken — Analyst

The patent expiry for glepaglutide.

Adam SteensbergExecutive Vice President, Research and Development, and Chief Medical Officer

Right. 7570, it’s a multiple clinical study. And as you can see in clinical trial set up currently we can with three doses — 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 II study quite quickly after that as you know, with Phase I study if 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 give final update early next year and our plan for that molecule. Glepa, 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 data and what you can gain [Indecipherable] development. So that would likely take us into the third level studies. And then we — as you know, we also have orphan drug designation in the US with this molecule.

Do you want to take —

Emmanuel DulacPresident and Chief Executive Officer

[Indecipherable] Yeah. And then for the HypoPal, yeah Matt, you should take it.

Matt DallasSenior Vice President and Chief Financial Officer

Yeah, on the HypoPal, we have not issued guidance, nor are willing to be issuing guidance in the near term. We haven’t guided the PDUFA date. It 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, short-term revenue expectations on the launch there.

Peter SehestedHandelsbanken — Analyst

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 DulacPresident and Chief Executive Officer

Yeah, we — I would 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, it’s 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 SehestedHandelsbanken — Analyst

Thank you very much. Thank you.

Operator

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

Jesper IlsoeCarnegie — Analyst

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 way too much into 2022. But assuming that glepaglutide is pushed into 2022, can just highlight what news flow to expect in 2021.

Emmanuel DulacPresident and Chief Executive Officer

Yeah. So, I mean, I think, let’s try to take it in the older. So the HypoPal PDUFA date is on March 27, 2021. We hope to start Phase II for dapiglutide, the 7570 in 2021. We would as well initiate Phase III for the bi-hormonal 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 SteensbergExecutive Vice President, Research and Development, and Chief Medical Officer

And maybe I can just add, Phase III — second Phase III in CHI, the small children, certainly where we expect a 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 trade-in. And, yeah, those are at least some of the key —

Emmanuel DulacPresident and Chief Executive Officer

Some of the major ones.

Adam SteensbergExecutive Vice President, Research and Development, and Chief Medical Officer

Major ones.

Jesper IlsoeCarnegie — Analyst

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

Adam SteensbergExecutive Vice President, Research and Development, and Chief Medical Officer

Yeah. But that’s — that’s with ’21 to know.

Jesper IlsoeCarnegie — Analyst

Okay. Thank you, guys.

Emmanuel DulacPresident and Chief Executive Officer

Thank you.

It seems like there are no further questions. Sir, please continue.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

[Operator Closing Remarks]

Duration: 50 minutes

Call participants:

Mads KronborgHead of Investor Relations and Communication

Emmanuel DulacPresident and Chief Executive Officer

Matt DallasSenior Vice President and Chief Financial Officer

Adam SteensbergExecutive Vice President, Research and Development, and Chief Medical Officer

Michael NovodNordea — Analyst

Graig C. SuvannavejhGoldman, Sachs & Co. — Analyst

Alan CarrNeedham — Analyst

Etzer DaroutGuggenheim — Analyst

Lucy CodringtonJefferies — Analyst

Peter SehestedHandelsbanken — Analyst

Jesper IlsoeCarnegie — Analyst

More ZEAL analysis

All earnings call transcripts


AlphaStreet Logo

Leave a Reply

Your email address will not be published. Required fields are marked *