Zealand Pharma A/S

CSE:ZEAL

Earnings Call Transcript 2020-Q1

[Operator]

Ladies, and gentlemen, thank you for standing by, and welcome to the Zealand Pharma results for Q1 2020. [Operator Instructions] Also, I must advise that the call is being recorded today, Thursday, the 14th of May 2020.And without any further delay, I would now like to hand over the call to your first speaker today, Ms. Lani Morvan. Thank you. Please go ahead.

[Lani Pollworth Morvan, Investor Relations & Communications Officer]

Thank you, and welcome to Zealand Pharma's conference call for results from the first quarter of 2020. Participating in today's call 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 first quarter and subsequent events. After the prepared remarks, we will open the call to take your questions. You can find the Q1 interim report, the related company announcements and additional supporting information on our website at zealandpharma.com.As the company headquartered in Denmark, our financials are reported in Danish krone, also referred to as kroner. Key figures may have been converted to U.S. dollars for convenience.On Page 2, I will 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.And with Page 3, I will now turn the call over to CEO, Emmanuel Dulac.

[Emmanuel Dulac, CEO & President]

Thank you, Lani, and thanks to everyone for joining today. We are pleased to share with you today the results of Zealand Pharma's strong start in 2020. We are delivering on our commitments despite the unprecedented and challenging situation created by the coronavirus pandemic. So despite the global health crisis, we successfully filed the new drug applications with the FDA for the dasiglucagon HypoPal rescue pen. This was an exciting accomplishment, and the first NDA filed by Zealand for its fully owned compound.We also announced positive results from a Phase II clinical trial with mini dose of dasiglucagon as a treatment for post bariatric surgery hypoglycemia. This could yet be another potential valuable treatment modality for this molecule, and we are evaluating how it can supplement our development pipeline.We secured DKK 137 million or approximately $20 million in additional funding from a major U.S.-based investor during a time when many investors had paused activity. Last but not least, we completed the acquisition of Valeritas business. This significantly accelerated our efforts to build a U.S. organization, ready to launch 4 products in the coming 4 years. With the acquisition, we transferred 110 employees, systems, processes and the majority of supporting contracts to complete the foundation of our U.S. operations. This business continues to support a revenue-generating product, the V-Go insulin delivery device, and is ramping up from the anticipated launch of the dasiglucagon HypoPal rescue pen early next year. These achievements were made despite the rise of the global coronavirus pandemic.Page 4 highlights the areas where we have taken actions to mitigate potential negative impact from COVID-19. Zealand continues to monitor the crisis, and take precautions to keep our employees, patients, business and clinical partners safe. We have adapted the way we work to support our committee's efforts to reduce transmission of COVID-19 and protect our employees, while continuing to provide patient care and keep our business running. The impact of COVID-19 on our research activities has, thus far, been minimal. Employees can work from home, and they have been doing so. Those needing to work in laboratory facilities are divided into shifts to reduce the number of people gathered together at one time.Consistent with our announcement of April 2, we have continued our clinical trials, while working with authorities, investigators, trial sites and CROs to minimize site visits and ensure optimal trial follow-up. As a result of our team efforts, we have managed to maintain already enrolled patients in the ongoing CHI and SBS studies. Several clinical sites paused enrollment of new patients into trials to accommodate the pressure on hospital systems caused by the initial phase of the COVID-19 outbreak. But we are starting to see some sites reopening for new patient enrollment, and Adam will provide more insights within the context of our development programs. Engagement with health care providers and patients have been transformed by leveraging virtual meetings, training and support. Commercial activities in the U.S. are focused on stabilizing business for V-Go, while ensuring a continued high level of service and support for patients who have already been prescribed the device. Despite the pandemic, we maintain a clear vision of our long-term goals. We continue executing on our aggressive strategy, and our team stays focused to deliver on our promises.Turning to Page 5. I will hand over to our CFO, Matt Dallas, to review financial results for the first quarter of 2020.

[Matthew Donald Dallas, Senior VP & CFO]

Thanks, Emmanuel. On Page 5, you see Zealand's income statement for the first quarter of 2020, and how it compares with the first quarter of last year. The net operating result for Q1 was a loss of DKK 177 million. R&D costs mainly relate to the regulatory efforts to support the NDA filing of the dasiglucagon HypoPal rescue pen, clinical development of the dasiglucagon and glepaglutide programs as well as the preclinical research activities. An increase in administrative costs compared to the same period last year is due to higher consultancy and legal costs, of which DKK 7.1 million relates to the acquisition of the Valeritas business and also new company headquarters and increased compensation expenses.Page 6 illustrates our financial position and ability to support our growing business. Net operating expenses, shown on the left, were DKK 171 million for the first quarter. On the right side, you can see that our cash position remains strong. As of March 31, 2020, cash, cash equivalents and marketable securities amounted to DKK 1.3 billion. In Q1, we received DKK 137 million in a private placement with a U.S.-based investor. Not reflected in the Q1 cash is the anticipated milestone payment of EUR 20 million to be received after the first patient is dosed in the Phase II trial being conducted by Boehringer Ingelheim.Moving to Page 7, we are updating our financial guidance for the year. Net operating expenses in 2020 are now expected to be within the range of DKK 950 million to DKK 1 billion. The increase in guidance, compared to the prior guidance of 2020 of DKK 790 million to DKK 810 million, is due to the completion of the asset purchase agreement for Valeritas which closed on April 2. The acquisition increased Zealand Pharma by 110 employees in the United States, and added the V-Go program to the Zealand portfolio. In 2020, Zealand expects revenue from existing license agreements and the product sales of the V-Go wearable insulin delivery device. However, since such revenue is uncertain in terms of size and timing, Zealand is not guiding on such revenue.Now going to Page 8, I will turn the call over to Adam to discuss highlights from R&D.

[Adam Sinding Steensberg]

Thank you, Matt. So on Page 8, you'll see an overview of Zealand's robust pipeline. I will speak to our franchise programs on the upcoming slides, but here, I would like to highlight the changes in our partnership with Boehringer Ingelheim.So in Q1, we gained the global rights to amylin, and we are excited about the amount of data provided by Boehringer, and we are evaluating our opportunities with this molecule as we speak. This comes after a decision by Boehringer to focus on the development of our long-acting GLP-1 dual agonist. And we are very happy to report that Boehringer is now recruiting for the Phase II trial with this molecule and to confirm that Zealand is entitled to a EUR 20 million milestone when the first patient is dosed in this study. In addition, we are also very pleased to announce that Boehringer has informed us that they intend to expand development of this molecule to also target treatment of NASH.On Page 9, you will see the multiple treatment modalities that we are pursuing with dasiglucagon in addition to the HypoPal rescue pen which is reviewed by FDA for treatment of severe hypoglycemia in diabetes. We aim to change the life of children and families living with congenital hyperinsulinism by developing dasiglucagon as chronic infusion pump therapy for these children.Our first Phase III study, with children aged 3 months to 12 years, continues to making strong progress with patient enrollment, and we expect to have the last patient enrolled within the coming months and reconfirm our expectations to report the results of this study this year. For the second Phase III trial, with 12 children, from newborns up to 1 year, we also had that study ongoing, and we have 3 out of the anticipated 6 sites actively screening for patients and ready to enroll.Driven by our ambition to transform management of type 1 diabetes and reduce the burden of living with this serious condition, we are working with Beta Bionics to develop dasiglucagon produced in the iLet bihormonal bionic pancreas. We believe that the results from the Phase II study announced last year demonstrated unprecedented glycemic control of the bihormonal iLet compared to an insulin-only setting. And we are happy to see the progress made by Beta Bionics, who have now started recruitment into their Phase III study with the insulin-only device setting as we continue to make good progress with the FDA on the bihormonal pivotal Phase III trial, which is expected to start later this year.Finally, we are evaluating the potential of mini doses of dasiglucagon as a novel treatment for patients who have experienced recurrent events of meal-induced hypoglycemia following biotic surgery.On Page 10, you will see a summary of the top line results from the Phase II approval concept study of dasiglucagon in PDH, which was reported earlier this year, and a trial demonstrated that small doses of dasiglucagon. We're able to significantly reduce the time spent in serious hypoglycemia following a standardized meal in patients with this condition. And we are and remain highly encouraged by these results, and we'll continue to explore the potential of mini doses at dasiglucagon to treat and avoid hypoglycemia seen in conditions such as PDH and type 1 diabetes and look forward to provide further updates to the market.Moving to Page 11. Here, we review our programs targeting treatment of short bowel syndrome. Glepaglutide is our long-acting GLP-2 analog, with potential for weekly administration in an auto-injector. While we saw significant ramp-up in patient screenings across our nearly 40 sites early in the year, several of these sites had to pause enrollment of new patients into the trial to accommodate the pressure on hospital systems caused by the initial phase of the COVID-19 outbreak. We are now starting to see some of these sites opening up a new patient enrollment and expect this positive development to continue over the coming months. Thus, our current estimate is that the interruption of the clinical -- at the clinical site level has, however, paused results of the study into the second half of '21.ZP7570 is a unique dual acting GLP-1/GLP-2 agonist, which we believe represents the next innovation in treatment of short bowel syndrome. We expect to have results from this single-ascending dose Phase Ia trial here in 2020 and plan to initiate the Phase Ib multiple-ascending dose, safety and tolerability trial in '21.With Page 12, I will now return the call to Emmanuel for his closing comments.

[Emmanuel Dulac, CEO & President]

Thank you, Adam, and thank you, Matt. I would like to conclude by emphasizing Zealand's outstanding job of ensuring progress across our business initiatives. Our company and team has been one of the most resilient and positive I have seen in my career, despite an unprecedented period of external challenges. Our development pipeline has never been more robust. We have transformed into a commercial organization and are preparing to launch 4 products in 4 years.2020 has been and will continue to be a momentous time for Zealand. And we look forward to the prospects of the rest of the year, both for our company, but also for the frontline health care professionals dealing with the pandemic today.With that, we are now ready to take your questions.

[Operator]

[Operator Instructions] So our first question is from the line of David Lebowitz from Morgan Stanley.

[David Neil Lebowitz, Vice President]

When you look at the expense guidance for this year, I am expecting that is most of the incremental difference between this guidance and last guidance, would we expect that to be falling under the G&A side of things, considering the addition of the 110, I guess, person in the commercial side of things?

[Emmanuel Dulac, CEO & President]

Thank you, David. I will ask Matt actually to address this question.

[Matthew Donald Dallas, Senior VP & CFO]

Yes. The majority of the increase was all tied to sales, general and administrative expense as part of the Valeritas acquisition and the 110 employees, all of which were commercial or G&A in nature.

[David Neil Lebowitz, Vice President]

And I guess, given that the acquisition is completed, I guess, what are the state of the preparations, obviously, that's part of it that you are doing for a potential dasiglucagon launch.

[Emmanuel Dulac, CEO & President]

So this one I can take. So we are done with the integration of the existing systems, the existing processes. We are actually now starting to deploy, with, say, a stronger organization. So filling some of the gaps and adapting as well to not only to get V-Go back to growth, but as well preparing the launch of the rescue pen. And so as a result, we are actually now engaged in multiple efforts on the marketing side to be able to ready our teams and on the medical affairs side as well on the access side, to ready the team for the launch of preparation for it. So I don't know how to actually put, I would say, a percentage in terms of time, but I think it's probably like right now, a big amount of time spent on V-Go. And there is actually a separate team on the marketing side working, I mean, 100% of the time on the HypoPal rescue pen.

[David Neil Lebowitz, Vice President]

And I guess on the glepaglutide enrollment, has that started to get back on track after delaying the new patients? Or are there still some sites that are delaying patients from starting?

[Adam Sinding Steensberg]

I can take that question. So there are still sites that are not enrolling new patients. As we also discussed at our last call, our first focus area was to adapt the protocol, so we could allow the patients who are already enrolled or just about to be enrolled to keep them in the study, and that we have secured. Then we have by protocol managements and working according to updated guidelines. Then we have, you can say, on a side-by-side basis, interacted with investigators and sites to understand when and how they will start to open up again. And throughout the period, actually, we have seen some sites that have been able to screen a new patient or randomized one. But clearly, it was not had been there -- I mean it has -- it was -- the activity level was reduced significantly compared to where we were in January and February.What we are starting to see now over the last few weeks, actually, is it's that some of the sites that have been asked to not randomize new patients in 2 studies, they have been based on guidance from local authorities, has been allowed to now start recruiting again. So that's a very positive development that we are seeing in Europe. It's, I would say, very much a country-by-country basis. What we are seeing in the U.S., it is depending on which states we are active in where we will some have actually managed to continue some randomization in the period. So we are not where we were yet, but we are hopeful that over the next few months, we will get to where we were.On the positive end, you can say some of the -- as we have also discussed on former calls, then it is -- this is a complex study, and it puts quite a burden on the sites. And what happens right now is that the patients who were already enrolled, they will, of course, complete trial participation which means that once the sites are ready to enroll new patients, they will also have the hands to take care of these patients. So we are hopeful that, that will get back to, you can say, significant numbers of enrollment again in the coming months.

[Operator]

The next question is from the line of Lucy Codrington from Jefferies.

[Lucy-Emma Mary Sarah Codrington-Bartlett]

I've got a couple. Firstly, would it be possible for you to disclose what kind of how -- what percentage of patients have already been recruited into the glepaglutide trial? And with the data being slightly delayed, is there still potential that the product could still be filed within 2022? Or is that now likely to be pushed into 2023?Secondly, the Boehringer product, I guess, is -- are you still -- do you still think first patient in could still be within this quarter given COVID-19 disruption? Or could that be delayed? And secondly, on that product, any read-across from the recent semaglutide data reported yesterday? And then finally, just on the V-Go device, just what your plans are for this product? How important it is compared to the rest of the pipeline?

[Emmanuel Dulac, CEO & President]

Okay. I will let Adam answer the first two questions. I'll take the V-Go last.

[Adam Sinding Steensberg]

Okay. If we just start with the BI question. So first of all, with the GL-1 glucagon, dual-acting GL-1 glucagon, where we announced that Phase II has been initiated, then we can say we have active screening of patients right now. So we would definitely expect a randomization and dosing of the patients very, very soon and within this quarter. So that study is actually actively recruiting, and the data released by Novo yet today on high-dose sema, that I think is a very impressive data set. The study that BI is running actually includes sema comparator arm. So it will, at least, give some opportunity to compare efficacy once we get the results from the Phase II study.What I would say, again, what we are highly encouraged around is that BI is also now pursuing NASH. Because if you look into the modality of the GLP-1 and the glucagon analog, it really is very interesting biology when it comes to the liver.On glepa, I would say we have around half of the patients enrolled screens that randomized into the study when -- here in this period. And then -- so that's where we have to work from. And so you can say, time lines, as we communicated today, we pushed the expected results into the second half of '21 based on what we have seen so far. But ultimately, of course, things depends on how the different clinics they get back in shape. But what we're seeing right now is actually a quite good momentum in that. I'm actually not clear. I cannot remember if you have a question on 7570. But I think you should just take the V-Go now, and then we can come back if I didn't address all the questions you have.

[Emmanuel Dulac, CEO & President]

Yes. So on V-Go for us represent the first commercialized product. So I think we are learning a lot from it. At the same time, this is a product which is commercializing the exact same target audience that we will be marketing our rescue pen, HypoPal rescue pen. So there is -- I mean, anything we do right now with V-Go has a synergistic effect with HypoPal rescue pen. So this is very important for us to learn actually from that.In terms of size, it's a small product right now. What I must say is -- puzzling is that I think each time you look at V-Go, I mean, you can realize it's a very good product. V-Go demonstrated clinically relevant reductions in A1C with less insulin, for example. It is actually a small product. It's simple to use. It's delivering both the baseline as well that the meal-time insulin in one product. It reduced the number of injection. It's -- I think it's been proven to be cost-neutral, with less injections, with better insulin control. So when you look at the data attached to the product, it's pretty compelling. And I think there's a lot of work going on right now. So we don't have a full assessment, but I think it seems to be like there is a lack of awareness of the product. There is a lack of adoption potentially versus the potential of the market.So we are learning, and so we will provide more insights as we develop our knowledge around this product. But the good thing that, again, we're playing in our field. This is exactly where we are going to operate with the HypoPal rescue pen. So it's all -- right now, it's all positive for us. And plus, it provide us like a baseline revenue that is not huge, but that is not neglectable as well.

[Operator]

The next question is from the line of Michael Novod from Nordea.

[Michael Novod]

Actually, it's Michael from Nordea Copenhagen. So actually, regarding ZP7570, maybe you can just give an update on that. I think, Adam, you were just about to mention it. Also in the light of -- it seems like Takeda has decided to close down its TAK-681, maybe also if you have any kind of knowledge about that would be highly appreciated. How you see that sort of pipeline market going forward?And then, secondly, on -- again, on V-Go, it seems like when you look at the underlying numbers from either Symphony or IQVIA that it's actually progressing quite stable. Is that something that you expect to continue throughout the year? Maybe give some update on that. And then lastly, on the dual-hormone pump, I can see you are still expecting it to start the trial in late '20. I fully acknowledge that you are sort of -- or Beta Bionics is screening patients, but isn't there a significant likelihood that this is going to at least move another 6 months, and that means also the dual-hormone going into -- starting in 2021?

[Adam Sinding Steensberg]

Okay. Thank you, Michael. Maybe I can start by addressing 7570 and then DHAP. And on 7570, we -- as I said, we still expect to be able to report the results from the Phase Ia study later this year. And as we've also discussed, and as everybody are aware, it is a challenging time to do clinical studies, especially first-in-man studies and Phase I, early Phase I study. So that is also -- in that light, you have to consider that we now continue to start the Phase Ib in '21.You mentioned the decision by Takeda to close their long-acting GLP-2 program, which was in Phase I. And of course, that we consider that very positive news for Zealand Pharma. And I think it's also -- I mean, of course, we can only speculate why, but you can also put it this way that we have a lot of confidence in glepaglutide especially given the current competitive market. So we also need to prioritize our resources in the right places. So that is a combination of all these things that are reflected here, I think, for 7570.For the DHAP program, I am personally extremely excited about the fact that Beta Bionics has been able to start screening. And if you go to clinical trial backup, you can see all the sites involved in the insulin-only study, which, by the way, also decides that are going to be involved in the DHAP, dual-hormone studies are actually recruiting right now. I think that's a strong sign of the commitment and the effectiveness with which they operate. And we have all the time, as I said that, that study has to be started, initiated before we start the dual-hormone artificial pancreas study. It is still set to start late this year.And as we have also said, at Zealand Pharma, we are actually ready to support the start of that study. And we are not in a situation where we would change the guidance because we -- what we see with Beta Bionics right now is that they are actually able to screen these patients so -- and have the sites open as planned. So in the best case and a good case scenario, then they are also able to operate despite a consequence, despite of COVID-19. And of course, with the device that they're developing, it is helpful that it's a lot of that can be handled remotely. So we are not changing our guidance here.

[Emmanuel Dulac, CEO & President]

Yes. Thank you, Adam. As well, I would say that you have to keep in mind as well that the patients who are actually joining this insulin pump only would be eligible for the next study as well once they are completed. So that's actually very positive for us as well. Same sites, a bunch of volumes of patients that's actually pretty positive.

[Adam Sinding Steensberg]

And one question on...

[Michael Novod]

Yes. Just on V-Go, how you sort of predict the sort of the weekly numbers to be -- it looks pretty stable actually. So just to get a feeling of whether that's sort of a stability we should expect to continue throughout the year.

[Emmanuel Dulac, CEO & President]

Maybe that's a question for Matt, actually, who is looking at the numbers.

[Matthew Donald Dallas, Senior VP & CFO]

The stability of the V-Go program? It's hard to say right now. I mean we like the program. We have faith in the commercial effort. Right now, everything is a little hard to read based on outreach that the commercial teams can do. So it's -- we need to take a little bit of time and watch the progression.

[Operator]

Next question is from the line of Etzer Darout from Guggenheim Security (sic) [ Guggenheim Securities ].

[Etzer Darout, Senior Analyst]

Just a couple of one questions. So first, I just wondered, given that this is -- the BI 456 906 is a partner program. Do you have a sense of where we could maybe see the data set that's kind of in front the -- sort of progressing to Phase II and sort of their intent to expand into NASH? For the dual hormone, I think Beta Bionics starting to trial recruitment is certainly positive. But maybe if you could give us a sense of what types of conversations are currently ongoing with the FDA. And what kind of need to get agreement on par to starting the Phase III program.

[Adam Sinding Steensberg]

Yes. So for -- on the dual-acting here, the one glucagon, it is up to BI to decide when to release data, and so we cannot comment more on that. The only thing, as we have shared before, is that we see a huge excitement in the team. And also, it is a very strong signal from BI when they are communicating that they are also going to push this forward in NASH. And we have, all the time, had a high belief in the data, and I think there are other preclinical data available for other compounds with the same modality, which suggests that the mode of action of having both GLP-1 and glucagon actually is something that can provide very significant weight loss also more than what you have seen with single-acting agents. And when it comes to the nutritional status of fatty liver then glucagon, by nature, is actually will enter that liver from nutrition. So that is, I would say -- that's the evidence we can talk about right now. And when BI is ready to share the data from the lead molecule here, we cannot comment on that.On the dual-hormone artificial pancreas and the interactions with FDA, we do not have updates to the market right now that we can share. What we can share is that we are still progressing towards a single Phase III study and comfortable with the numbers that we're going to have in that study. And we expect to be able to provide, you can say, a firm trial design around summer this year.

[Operator]

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

[Jesper Ilsoe, Research Analyst]

Two questions, one on NASH and one on glepa. So on NASH, I appreciate all the comments you've made on the call. Just putting Zealand into perspective, I know BI is running it, but given all the things we've seen in the area with Novo, reporting data, Janssen failing. It's just how you perhaps can see that asset if -- in the current evolving competitive field in NASH? I know you haven't started the study, and so early stages, but just to give sort of like your thoughts on this asset in NASH. And I also appreciate again that BI is running it, and you don't have the data and everything. But just do you have any preclinical data on the compound as such to give you confidence besides the fact that the GLP-1 has seemed to work in NASH? That's the first question on glepaglutide.I'm just trying to assess whether we should expect the final Phase III data to the base case being in Q3 '21 or Q4 '21 because, of course, this is a very key part of your story. And there has been some delays in the past. You previously expected data late 2020, then you expected H1 2021. I appreciate the impact from COVID, and it's not in your hands. But it's just how big a delay you've seen on glepa? Any thoughts and color there would be appreciated.

[Adam Sinding Steensberg]

Yes. On the last question, I cannot specify it more because it actually all depends on how things are developing. Personally, I'm more positive now than I was 2 weeks ago, because we are starting to see this opening at specific sites, and I think we are all learning more around this, how to deal with this situation. But we cannot specify it more than what we have done with H2 '21.On the dual-acting agonist for NASH, we have preclinical analysts also been published data on a former lead once-daily analog. And I cannot speak for BI, I can only speak from a Zealand point of view. And perhaps my personal point of view is that if we -- normally, I would be very skeptical around moving into NASH as a company because, as you know, especially if you have had an antifibrotic agent in development for whatever disease, then people have repositioned those for treatment of NASH because it's been such a hot area. Where we are starting to see some very significant and great results are with the GLP-1s, and the metabolic -- addressing the metabolic component a little bit earlier than maybe when you start to address the fibrotic. And I think, as you mentioned, that there are companies who have shown some promising data there.If you take the dual agonist and the mechanistic action of a dual-acting agonist, probably, NASH is the indication you should pursue with a dual agonist because of the effects of glucagon on the liver. And if you look into the preclinical data, we have published on obesity with a dual-acting agonist. Then, in my mind, in needs anything else that has been published with other single-acting agents. So that's why we feel that this is a potential future winner, as we have discussed. We also understand that it's huge programs, and it requires a very committed player like BI is in that field. But so -- but it's fair to say that from a Zealand perspective, we are really, really happy to see that they are also pushing this forward in NASH, because that is where we see very strong biology.

[Emmanuel Dulac, CEO & President]

If I can add as well, Jesper, I would say that the abandonment of the Takeda long-acting program clarify the story for these sites in terms of who they're going to be working with in the future. And so I think it helps us in terms of being able to engage with clinical sites as we come forward with glepaglutide. And they know that now it's going to be Zealand Pharma. And we have, as we said, 7570 behind. So it will help us in terms of engaging with clinical sites and accessing clinical patients.

[Operator]

The next question is from the line of Alan Carr from Needham & Company.

[Alan Carr, Senior Analyst]

A couple of quick around V-Go. Have all the supply chain issues that were experienced late last year by Valeritas, have those all been sorted out? And then with respect to CH1 (sic) [ CHI ] it sounds like you're close to full enrollment on the older kids' trial that -- can you give us an update on the smaller one and the younger kids? And then the last one is around bariatric surgery. What's the next step there? What do you -- what sort of trial are you all contemplating running there next?

[Emmanuel Dulac, CEO & President]

Adam, would you take the clinical questions? I'll take V-Go again.

[Adam Sinding Steensberg]

Yes. So on CHI, you're correct. We're very, very close to have all the children randomized into the study, and we actually have them identified. So it's -- this is a matter of how to get them to clinic. So that looks very, very good. On the smaller tune, as I said, we have managed to get 3 out of 6 sites that are going to enroll patients into this study activated and hopefully have the last sites activated quite soon. That means, on average, they need to randomize 2 patients each. But since they're units, they have to appear to the clinic before we enroll them. And we have had active screening for a few months now. And we have had patients who are close to get in, I would say, but we do not have the first in yet. So -- but it's -- I would say it could happen any day.And once we -- what we see is since these are -- it's actually on top of standard of care, this study, so it doesn't impose a lot of additional burden on the sites on the units, on the families, and it actually just provides an opportunity for these children to get out of IV, glucose, et cetera. So it is a study which we hope will not be impacted so much by the COVID situation, now that we are through this very, you can say, dramatic and chaotic phase where everybody has to adjust with how to work with COVID-19 around. So we are comfortable there, and we are managing to actually see progress.On the post bariatric surgery, next step is that, as I said, we will discuss with FDA. And as Emmanuel has also highlighted several times, it is a program where we have doing in mini-dose pen. So we actually have a pen that can give these mini doses. So you should see the development activities we are going to do for post bariatric surgery. The totality of what we're doing with the franchise, meaning that we are also considering the next steps in the type 1 diabetes market with a mini-dose pen, where we see a huge growth from patients and prescribers. So you could expect to see a broader development of effort within that pen -- in those pen developments.

[Emmanuel Dulac, CEO & President]

Yes. And Alan, you will note that we're not calling the pen right now. The multidose pen, our fifth product, our fifth launch. We're waiting to actually define a regulatory route for this product in the various potential indications. We can expect this product to be marketed. So that's why still, I would say, in development, I would say, right now.Regarding the V-Go, I'm happy to share that actually the technical issues that led Valeritas to have their stock out and supply issue have been actually identified and solved. So the matter now that we are dealing with is we are ramping back the production to the full capacity, and we are actually supplying -- we're starting to supply all the orders, delayed orders that we had, so that we can get the stock back to full -- again, full orders. So this is a matter of weeks.But in terms of technical issues, I remind you as well that this issue did not trigger a safety report to the FDA. It was just a capacity issue. So this is, I would say, work in progress. And we are -- the supply chain and the supply team is actually working night and days to get the orders to supply all the orders back. We have seen very, very happy customers, seeing their stock back and as well most of the patients had supply. So very few of them had a discontinuation. I think the team did a fantastic job to make sure that there was no holding during that period of time, so that everyone could have their supply as needed. But this is constant work. So we are monitoring it, and we are working on it on a daily basis.

[Operator]

Next question is from the line of Graig Suvannavejh.

[Graig Suvannavejh]

I just want to focus on the dual-hormone artificial pancreas program. Certainly, a really interesting program. And I'm wondering if the company plans to provide us perhaps a more extensive view on how we should think about the commercial opportunity at some point later this year. And can you also remind us of the relationship that you have with Beta Bionics? And kind of what the economics are in terms of whether it's the spend or on the back end on any potential commercial sales? How that might be split out?

[Emmanuel Dulac, CEO & President]

Yes, Graig, thank you for the question. So we have that in works, I mean, this better assessment and understanding of this opportunity. This is in motion. We have actually hired now full lease staff team for -- and a leader for this new indication, which we didn't have before. And I think this is a top priority for the leader of this brand. The situation right now is that we as well put a lot of resources on the integration -- and attention on the integration. And so I think we -- for the last, I would say, 3, 4 months, we put a bit less commercial attention to this dual-hormone pump, a bit more on the regulatory route, discussing with the FDA on the clinical design. And so as a result, I think as soon as we have, I would say, and we're able to communicate the Phase III design of the -- you will have a very clear understanding of the market potential for this product. So I know we have to wait a bit more to be able to communicate that openly, but I think it will be clear very soon.

[Adam Sinding Steensberg]

And the collaboration with Beta Bionics is a nonexclusive collaboration, but we collaborate closely and we have to do that. And then we -- because we engage with FDA together, and we're doing clinical studies together. And you can say the cartridge that we are developing fits exactly into the device. So it's a ready-to-use system that -- so it all adds to the simplicity. On the commercial space, we have not defined how to work together there, but it is clear that Zealand Pharma has -- expands right now are responsible for the cartridge, so selling the glucagon in a cartridge, and Beta Bionics are responsible for the pump. And each of our organizations are building commercial infrastructure. As you know, Zealand has now established a commercial infrastructure. So -- but it allows us to work with other home companies later, and it also allows data providers to work with other glucagon providers later if that -- if there would be some. So...

[Emmanuel Dulac, CEO & President]

Yes. The good -- very good news is that Beta Bionics hired their first leaders as well on the commercial side. So they're starting to build their commercial presence as well.

[Operator]

Next question is from the line of Thomas Bowers from Danske Bank.

[Thomas Schultz Bowers, Analyst]

A couple of questions from me. Just on glepa, just a sort of a follow-up here. Do you have any impression on how many patients actually was screened just prior to the lockdown? So how many patients are actually ready to go on treatment right away? And then also, glepa, is it fair to assume, with the delay into second half, that BLA timing would be realistic for first half of in '22?And then maybe I missed it, but just help me understand on the V-Go. So the revenue impact for 2020, you had DKK 23 million or DKK 22 million in revenue reported from Valeritas after 9 months in '19. So can you just help me with some numbers on the full year '19 sales? And how should we actually model this into the 2020? So is it fair to assume that maybe 6 months of sales and flat growth is what we would see here for '20?

[Adam Sinding Steensberg]

Okay. If I just start with glepa, I think it's actually -- it's difficult for me to comment more on the glepa. I think what we have and that is sites that are completely ready. We have patients identified. We had a list of when and how they should be enrolled into the study. And we had, you could say, a number of patients who are screened, and we have modified the protocol, so they can be randomized when they can enter the clinical site again. But it is clear that this has imposed an interruption to each of these sites. So -- but -- and it's coming back to this thing that we are seeing sites now that when all this was lined up to happen in, let's say, March and April, and now we are trying to -- and we're hopeful that they will now happen in May and June, for instance, with these sites that have now started, and there will be others as well will be June and July and others where it will be later after summer, for instance. So that is the rule.And then what will then happen after that is we need a second row of patients coming in a little bit later this year. So but that is -- yes. And so that's probably where we are there. And with regards to timing of the NDA, I think we will not -- we cannot be more clear than to say, of course, if we have results very early in second half of next year, then it could happen in '21. If we have them late in second half, then it will move into '22 before we submit.

[Emmanuel Dulac, CEO & President]

And maybe on the V-Go question, maybe I will ask Matt to take the numbers.

[Matthew Donald Dallas, Senior VP & CFO]

Sure. So with the Valeritas acquisition closing on April 2 of this year, we will record 3 quarters of product revenue for V-Go in Q2, Q3, Q4. Due to the time the transaction was completed as well as the nature of everything going on with COVID-19, and just the transition of the business from Valeritas to Zealand, it is tough for us to give any guidance right now on the product revenue that we're anticipating for the remainder of the year. We will look to clarify that as we move forward.

[Thomas Schultz Bowers, Analyst]

Okay. So at least when we're looking at DKK 23 million for the first 9 months of '19, it's not like we should expect any major deviations for that product in 2020. Is that fair to us to model on...

[Matthew Donald Dallas, Senior VP & CFO]

Again, Thomas, it's hard for us to say because within that, COVID-19 was not part of 2019 and we're in the process of evaluating everything at the moment.

[Operator]

No further questions, sir, please continue.

[Emmanuel Dulac, CEO & President]

Yes. Okay. So I just want to close by saying how happy we are to be able to engage with all of you actively, hopefully, live soon. It was a very good quarter for us. We are -- we actually are stronger as a result of being tested through the team through this crisis. No companies had this on their list of things to achieve, but I think we went through this and we met the, I would say, the guidance that we gave in terms of execution. Again, this is probably transforming the way we're going to engage in the future, which is something we still have to assess. But I really look forward to be able to engage more and be able to share more of the achievements that Zealand is pushing to date. And again, we're looking forward to a momentous year for 2020 for Zealand. Thank you, everyone. This concludes, I think, this call.

[Operator]

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