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Edited Transcript of ZEAL.CO earnings conference call or presentation 14-Nov-19 3:00pm GMT

Q3 2019 Zealand Pharma A/S Earnings Call

Nov 30, 2019 (Thomson StreetEvents) -- Edited Transcript of Zealand Pharma A/S earnings conference call or presentation Thursday, November 14, 2019 at 3:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Adam Steensberg

Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer

* Emmanuel Dulac

Zealand Pharma A/S - CEO & President

* Lani Pollworth Morvan

Zealand Pharma A/S - IR & Communications Officer

* Matthew D. Dallas

Zealand Pharma A/S - Senior VP & CFO

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Conference Call Participants

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* David Neil Lebowitz

Morgan Stanley, Research Division - VP

* Etzer Darout

Guggenheim Securities, LLC, Research Division - Senior Analyst

* Joseph Robert Stringer

Needham & Company, LLC, Research Division - Associate

* Lucy-Emma Mary Sarah Codrington-Bartlett

Jefferies LLC, Research Division - Equity Analyst

* Peter Sehested

Handelsbanken Capital Markets AB, Research Division - Research Analyst

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Presentation

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Operator [1]

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Ladies and gentlemen, thank you for standing by, and welcome to today's Zealand Pharma results for the Third Quarter of 2019 Conference Call. (Operator Instructions) I must advise that this conference is being recorded today, Thursday, 14th of November 2019.

And I would now like to hand the conference over to your first speaker today, Ms. Lani Morvan. Please go ahead, ma'am.

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Lani Pollworth Morvan, Zealand Pharma A/S - IR & Communications Officer [2]

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Thank you, and welcome to Zealand Pharma's conference call for the third quarter of fiscal year 2019. Leading today's call are Zealand's CEO, Emmanuel Dulac; CFO, Matt Dallas; and Chief Medical and Development Officer, Adam Steensberg. Emmanuel will provide business highlights from the third quarter and the period thereafter, Matt will add financial highlights and Adam will follow with updates from our research and development programs. After the prepared remarks, we will open the call to take your questions.

Joining for the Q&A will be Ivan Møller, Senior Vice President of Technical Development and Operations; Marino Garcia, Senior Vice President of Corporate and Business Development; and Rie Schultz Hansen, Vice President of Research and Interim Chief Scientific Officer.

You can find the company announcement containing the Q3 interim reports and additional supporting information in the Investors section of our website at zealandpharma.com. As the company headquartered in Denmark, our financials are reported in Danish crowns, also referred to as kroner. Key figures may have been converted to U.S. dollars for convenience.

On Page 1, 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 2, I will turn the call over to Emmanuel.

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Emmanuel Dulac, Zealand Pharma A/S - CEO & President [3]

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Thank you, Lani, and thanks to everyone for joining the call today. Zealand Pharma has made impressive progress so far this year. We clarified our strategy and advanced our pipeline. Our existing partnerships were strengthened. New partnerships were secured, and our financial strength was reinforced, notably for -- from a significant private placement with an existing shareholder. The accelerated pace of our company is driven by our highly committed employees, and we have added further talent to the team supporting both our recent achievements and long-term value creation.

If you turn to Page 3, you can see how all of these achievements are part of the exciting journey that Zealand is taking with that opportunity to improve patients' lives by providing leading peptide therapeutics. We have one of the most productive and promising platforms in biotech that has been built over the last 20 years. Our peptide therapeutics platform and know-how has been repeatedly validated by partnerships with industry leaders and the positive results demonstrated in our late clinical programs.

In 2019, we have taken big steps towards our ambition to become a fully-integrated biotech with medical and commercial operations. We are rapidly preparing to take our own products through registration and commercialization with 4 exciting launches planned in the next 4 years. The first anticipated to start in 2021.

Moving ahead to Page 4. You will see business highlights through Q3 and in the period afterwards. We were thrilled with the results from the pediatric study in the Stage 3 clinical programs for dasiglucagon to treat hypoglycemia. It was a positive note on which we completed the clinical program and turned full focus on preparing the NDA to submit early next year. The potential of dasiglucagon continues to grow. The Phase II proof-of-concept trial was initiated to explore dasiglucagon's potential to treat patients experiencing hypoglycemic events following bariatric surgery. The study will further examine the potential of mini dose of dasiglucagon. Adam will go into further details on this program later in the call.

Zealand completed its first-ever acquisition with Encycle Therapeutics. This opportunity was first raised by our research team, who were eager to bring in the lead asset, strategically expanding our pipeline with an alpha-4-beta-7 integrin inhibitor, with potential for oral delivery. We strengthened our financial position with a significant private placements from Van Herk Investments. They have been a long time investor in Zealand and the additional DKK 560 million investments showed their continued support and validation of our company.

Finally, it has been wonderful to have our new CFO, Matt Dallas, on board since October. Matt is a very experienced, seasoned biotech CFO. He lives in the Boston area, where we are establishing our U.S. operations. I welcome him to his first quarterly call with us. And we will hear from Matt in just a moment.

All of these accomplishments were made, while relocating to a new headquarters. Our new home maintains the strong Zealand culture, while embodying both our current transformation and future potential. We can see actual transformation as a construction work to install our laboratories continues. While inside the walls, there is definite positive support for Zealand staff ahead.

Page 5, summarize the acquisition of Encycle and the lead asset in focus for our research team. This was the first acquisition of -- in our company's history. The newly named ZP10000 or alpha-4-beta-7 integrin inhibitor, represents a strategic expansion of our pipeline in gastrointestinal disease and introduces new potential for oral bioavailability into our peptide platform. We appreciate that entities like Encycle recognize Zealand expertise and capabilities in peptide research and development. Finally, the financials around this acquisition and various investment approach allow us to sustain our peptide platform, while continuing to build our expertise and add new potential into our preclinical pipeline.

On Page 6, we consider our approach to commercialization in the U.S. Looking at the year ahead, we can pinpoint several deliverables that are important for our launch readiness. Early next year, we will open a facility in Boston. Boston is ahead for biotech innovation. We have been recruiting in this area already to fill the top leadership positions for our U.S. organization. Drawing on the deep talent already available there, our current partners, Alexion and Beta Bionics are headquartered in the Boston area, and we see opportunity to leverage being neighbors with them and the multitude of biotechs and pharma companies in Massachusetts.

Also, in early 2020, we remain on track to file the NDA for the dasiglucagon HypoPal rescue pen. We accelerated many activities this year to build up our U.S. presence to launch the dasiglucagon rescue pen. But it is important to realize that we are founding the team, who will launch 3 other potential treatments soon after the rescue pen. Zealand has an ambitious plan. During the next 4 years, and we are well on our way to ensuring successful operations in our largest commercial market.

Advancing to Page 7. I will turn the call over to CFO, Matt Dallas, to review financial results throughout the quarter -- the third quarter. Welcome, Matt.

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Matthew D. Dallas, Zealand Pharma A/S - Senior VP & CFO [4]

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Thanks, Emmanuel. Through the first 9 months of 2019, Zealand reported net operating expenses of DKK 431.5 million. Our net operating result was a loss of DKK 402.1 million. The chart on the left of the slide has been adjusted to reflect the guidance on net operating expenses, which remains in line with our ambition to bring several fully-owned programs to the market. We remain on track to meet the full year net operating expense guidance of DKK 580 million to DKK 600 million. On the right of the slide, you can see that our cash position remains strong, cash and securities at the end of the period was DKK 1.5 billion or USD 225 million. This includes funding for the Van Herk private placement completed in September.

With Page 9, I will turn the call over to Adam to discuss highlights from R&D.

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Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [5]

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Thanks, Matt. So on Page 10, you'll see the overview of Zealand's robust pipeline. Today, I will provide updates from the clinical programs and the programs partnered with Boehringer Ingelheim. Also, I think it's very good to note the early pipeline addition of the alpha-4-beta-7 integrin inhibitor, which Emmanuel discussed earlier.

On Page 11, I will review our clinical program targeting short bowel syndrome. First, glepaglutide, that is our long-acting GLP-2 analog with potential for weekly administration in an auto-injector. We expect to have approximately 50 patients randomized in the study this year and complete enrollment next year, mid next year. Delays in (technical difficulty) indications in U.S. and U.K. has caused a lower-than-expected patient enrollment in 2019. However, over the last quarter, our team has worked diligently to overcome these challenges and to build momentum on the newly activated centers. And based on these activities, we now have 32 sites activated and the majority of sites enrolling their first patients. Thus, all those results from the study will be pushed into the first half of 2021. We remain confident towards keeping our target for an NDA submission in 2021.

On ZP7570, we are seeing very good clinical progress. Based on the safety and tolerability of the single-ascending Phase I trial that was initiated in June this year, we are happy to announce that we now plan to initiate the Phase Ib multiple ascending dose, safety and tolerability trial early next year.

ZP7570 is a unique dual-acting GLP-1, 2 agonist, which we believe represent the next level of innovation in treatment of short bowel syndrome.

Moving to Page 12. I would like to turn your attention to the HypoPal rescue pen for treatment of severe hypoglycemia in diabetes. Last quarter, we reported the results from the pediatric Phase III trial and thereby, completed the full Phase III program for the HypoPal rescue pen. This study utilized the same dose as administered to adults, and the pediatric study confirms the median time to plasma glucose recovery from hypoglycemia of only 10 minutes from injection, which was also seen across the adult trials. We believe the time to rescue is going to be an important factor for patients and caregivers when considering rescue solutions for treatment of severe hypoglycemia, and we are looking forward to sharing more results from our program at upcoming scientific conferences.

With the clinical program concluded, we remain on track for submitting a new drug application to the FDA in early 2020.

Turning to Page 13. You can see that we are pursuing multiple opportunities with dasiglucagon, the HypoPal rescue pen. Driven by our ambition to transform the management of Type 1 diabetes and to reduce the burden of living with this serious condition, we are working with Beta Bionics to develop dasiglucagon for use in the iLet bihormonal bionic pancreas. We believe that the results from the Phase II study announced in Q2 this year demonstrated unprecedented glycemic control by the bihormonal iLet compared to an insulin-only setting. And together with Beta Bionics, we're working closely with FDA to plan the pivotal Phase III trial that is set to begin late next year.

Our third dasiglucagon program aims to change the life for children and families living with congenital hyperinsulinism. In our first Phase III study with children aged 3 months to 12 years, recruitment continues to make strong progress with 16 patients now randomized through the end of October, and results from this study is expected in 2020. The second Phase III trial will enroll 12 CHI children from newborns up to 1 year, and is still planned to start in this quarter.

Finally, in October this year, a new clinical program was initiated for dasiglucagon to evaluate its potential as a novel treatment for patients with post-bariatric surgery hypoglycemia. And we expect results from this Phase II clinical proof-of-concept dose-finding trial in 2020.

On Page 14, we'll provide more details on the opportunity for dasiglucagon mini dosing to patients suffering from frequent hypoglycemic events that are difficult to manage by carbohydrate ingestion. A number of patients who have undergone bariatric surgery as a treatment for obesity experienced reactive hypoglycemia after eating a meal. Thus, ingesting additional food or drinking to increase plasma glucose is not an option. There's no approved treatment option for these estimated 6,000 patients in the U.S., who suffers from this serious condition and we believe that dasiglucagon in a multiple dose pen may provide an attractive treatment option.

We also believe that dasiglucagon mini doses may provide an attractive treatment solution for people with Type 1 diabetes, who experiences hypoglycemic events and for whom eating and drinking carbohydrates is not an option similar to the post-bariatric patients. So our team is [enthusiastic] about these potential usages of dasiglucagon and we look forward to the results from the Phase II study next year and to continue exploring this as a full treatment modality for dasiglucagon.

Moving to Page 15. The final R&D program update for this quarter are with our partner, Boehringer Ingelheim. For GLP-1/glucagon dual agonist, we announced in earlier Q3 that Boehringer decided to advance this target to Phase II based on positive outcome in Phase I. The Phase II trial is expected to enroll the first patients this quarter and will be a 16-week randomized parallel group dose-finding trial in 410 patients with Type 2 diabetes. The primary comparison will be to placebo and semaglutide will be included as an active comparison. The main objective of the study is to explore, execute changes in Hba1c and secondary assessments include changes in body weight.

On the Amylin program, we expect updates from Boehringer early next year and, thus, moving Phase I initiation into 2020.

Going to Page 16. I will now turn the call to Emmanuel for his concluding comments.

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Emmanuel Dulac, Zealand Pharma A/S - CEO & President [6]

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Thank you, Adam, and big thanks to the research and development teams for the outstanding progress to date, and congratulations on all of the positive results demonstrated throughout the study. Page 17 shows the major milestones that Zealand Pharma has accomplished in 2019. We have advanced all of our late-stage clinical programs and seen positive results from 2 of them so far. We advanced our preclinical program into Phase I and supplemented our early pipeline with the company's first acquisition. Our existing collaborative effort with Boehringer Ingelheim and Beta Bionics made strong progress. To validate our expertise in peptide when developing innovative therapeutics, we formed a new exciting partnership with industry leader, Alexion, and most recently secured significant funding from existing shareholders Van Herk Investments.

So 2019 has been a remarkable year for Zealand. We are moving faster than ever, while maintaining integrity in our operations and clinical activities. In 2020, we look forward to submitting the rescue pen NDA in addition to delivering on our clinical programs as we continue to create value for shareholders by developing innovative peptide treatments.

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Lani Pollworth Morvan, Zealand Pharma A/S - IR & Communications Officer [7]

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Thank you, Emmanuel. This concludes our prepared remarks, and thank you for your attention thus far. Karl, we are now ready to take questions. If you would please open the lines.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from the line of David Lebowitz.

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David Neil Lebowitz, Morgan Stanley, Research Division - VP [2]

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Would you be able to compare the actual patient experience of administering the HypoPal pen versus the experience of administering other rescue pens that are on the market?

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Emmanuel Dulac, Zealand Pharma A/S - CEO & President [3]

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Yes, Adam will take this question.

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Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [4]

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Thank you, David. Thanks for the question. I think it's, of course, a highly relevant question, but as you will also notice, our clinical program have used the old glucagon kits as comparisons, which are the products for reconstitution. We have not done direct comparisons to the current, the approved or recently approved, ready-to-use solutions. The only thing we can share is, of course, outcome of market research that we have conducted, which suggests that both prescribers and patients prefer an injectable over a nasal. But I mean, these are market research data, so we have no direct comparisons on these things from patients, yet.

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Emmanuel Dulac, Zealand Pharma A/S - CEO & President [5]

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Yes. However, I mean, now Phase III are available for all these products. And so I think you can look at -- indirectly compare the studies and results but they -- just a caution, they use actually somewhat different endpoints. But there are some interesting findings that shows product difference. Again, there hasn't been choices for patients in the past. So I think the advantage now that patients would have the choice between several products. So there will be actually a more scrutiny on differences among products. We believe we have actually a very good product actually for patients.

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David Neil Lebowitz, Morgan Stanley, Research Division - VP [6]

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And is the pen that's used with dasiglucagon, similar to the pen that will ultimately be used for glepaglutide?

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Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [7]

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They are similar, but they are not same.

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David Neil Lebowitz, Morgan Stanley, Research Division - VP [8]

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I guess, how will that be different ultimately?

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Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [9]

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So those are, of course, subcutaneous injections, but the rescue pen has been designed to serve and rescue emergency need and the pen used for test for glepaglutide is designed for chronic use. So I mean, sorry, I repeat for, yes, for chronic use and not in acute setting. So similar concepts, auto injectors, both of them, subcutaneous, but they're not the same.

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Operator [10]

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Our next question comes from the line of Etzer Darout.

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Etzer Darout, Guggenheim Securities, LLC, Research Division - Senior Analyst [11]

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Great. Just a couple for me. As far as the delays in the U.S. and the U.K. for the site activation. I wondered if you could speak to maybe some of the specifics and whether or not they've been fully resolved? And I guess secondary to that, on the glepaglutide and ZP7570, I guess, given the time line expectation, could we see results for both of these studies in the first half of 2021? And then I'll have a follow-up question.

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Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [12]

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Okay. Maybe on your first question, I think I can happily say that we have resolved the issues with the U.K. and U.S. sites. And there are a little bit of a different issue. In U.S., I mean, it's known that it takes time to open sites in U.S. due to contract negotiations and so on and so forth. In addition to that, we have made some changes in the people working on the trial, and that we have very, very positive feedback from the CRO side. In U.K., it was actually an extrinsic factor due to some quality issues with the parenteral support that the patients were giving at the site that we -- so an external provider, that's supporting the clinical sites with parenteral support. They had some quality issues. Sites had to change providers. And of course, that created some logistic issues for these sites. That has also been overcome by the sites now. So they are now back in, you can say, normal operations and can focus on our clinical study. So in that sense, we are actually very happy with the development we have seen, I would say, in the last 2 months in the study and design activation. The last question, could you just repeat that, the last part of your question?

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Etzer Darout, Guggenheim Securities, LLC, Research Division - Senior Analyst [13]

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Yes. I guess, given -- so the expectations on the glepaglutide results now in 2021. Could we also see ZP7570 Phase Ib results in that same sort of time frame? The...

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Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [14]

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Yes, for ZP7570, we expect to have the results in 2020, I would say, of both the single-ascending dose and the multiple-ascending dose trial. So they will be coming up next year.

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Etzer Darout, Guggenheim Securities, LLC, Research Division - Senior Analyst [15]

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That's great. And I guess the other question is going back to sort of the severe hypoglycemia market, is it too early in terms of seeing what impact sort of the competitive agent, the Baqsimi product has had sort of on that market? Or do you think that's something that would take a little bit more time to kind of start seeing?

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Emmanuel Dulac, Zealand Pharma A/S - CEO & President [16]

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No. There are some actually publicly available data that have shown a very good response to promotion in the market. So again, this market hasn't been actively promoted for the last 15 years. And the launch of Baqsimi has actually injected some -- much wanted actually energy and dynamic in the market. So over the last 10 weeks, globally, I mean, the market has expanded by 20%. And 17% of these 20% on new patients, new prescribed patients. So it's a very positive dynamic. And again, this market is expected to double or triple in the next 3 to 5 years. And I think it's taking the right direction right now. Again, there is no -- there hasn't been any product differentiation in the past. So I think, Baqsimi is actually the first new innovation in this market. We believe that one dimension, which is very important for patients, when they will have a choice, will be the speed at which they can manage these events, these hypoglycemic events. And so I think this is a very important dimension for us to focus on.

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Operator [17]

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Our next question comes from the line of Alan Carr.

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Joseph Robert Stringer, Needham & Company, LLC, Research Division - Associate [18]

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This is Joey on for Alan. A few more on the glepaglutide sort of enrollment. Could you provide us with -- you mentioned approximately 50 patients enrolled by the end of this year, but how many are enrolled as of now? And have you seen -- since you've sort of resolved these issues with the external providers, have you seen -- is it too early to see an uptick sort of in the enrollment from that? And just to be clear, was there any higher-than-expected screening failure rates? Or has that changed over time? I know that's a separate issue maybe than the parenteral support. But maybe if you could provide some more color on that, that would be great.

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Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [19]

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All right. Okay. Thanks for the question. I can provide a little bit more color on this. If I should just talk about the screen failure, then in the start of the year and the first half, we did see a little bit higher screen failures than anticipated. But again, this is a nice thing that we can learn and then educate the sites and the investigators. So we see a reduction in that. So that has clearly gone in a positive direction. On the external factors, that was an issue that was specifically related to U.K. sites and the provider of parenteral support, which has been solved. So that is not an issue. On the -- you can say the U.S. sites, that's where we had to make some changes also in the personnel at the CRO. And we have a very, very positive feedback from the U.S. investigators on the queue that they are now collaborating with from our CRO. So that is also something we consider. So if I should then -- on the number of patients we have in the trial right now, my belief is we are around or just below 40 patients as we speak, who have been randomized, and we guided for 50. And you can see the predictions now for when we will have the patients enrolled -- as I also mentioned in the call, we have 32 sites activated. Within the next month or 2, we expect that number to be around 37 sites. And then, as you know, it's a 129 patient study, meaning that we will have to recruit another 80 patients. So that if you just look at the number of sites, it's actually something we consider very doable. So with the new guidance, we would have to have, let's say, 10 to 15 patients entering the study per month, which is really in line with what we are starting to see right now. So that's why we have confidence in what we communicate here.

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Joseph Robert Stringer, Needham & Company, LLC, Research Division - Associate [20]

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Okay, great. So more of a hockey stick type of enrollment as you pick up the additional sites. And just a quick one on dasi, maybe just some high-level commentary around the commercial prepping you're planning to build out your commercial team in 2020 and maybe what percent of the total commercial team have you hired thus far? And if you could just maybe a breakdown of how many you plan on hiring in 2020 before the launch?

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Emmanuel Dulac, Zealand Pharma A/S - CEO & President [21]

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Yes, Joey, that's an interesting question. But that's very competitively sensitive as well, so we will not communicate on the detail of the formation of the team and the number. But I can tell you that the plan we're following is very, very classic. I mean, we are actually starting to hire by all the leaders of each functions. And very quickly, then after the leaders are actually bringing on board their direct reports, and they are actually final -- detailing the plan to a level of detail that we haven't been able to implement yet. So I would say what we have today is typical in operational is probably 80% correct. And then as we go, we actually still refine it and we actually modify 80% or 90% of it as we go. So this is typical, and we adapt to the situation. Where we are right now in terms of to kind of respond to you without responding, but we have lined up all the leaders of all the different functions. And they are either on board or we are about to actually onboard them.

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Operator [22]

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Your next question comes from the line of Lucy Codrington.

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Lucy-Emma Mary Sarah Codrington-Bartlett, Jefferies LLC, Research Division - Equity Analyst [23]

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Just a couple for me. The first question relates to the artificial pancreas. Given that we already -- you've already had some meetings with the FDA, just wonder why the Phase III is not going to start until the -- toward the end of next year? And then if you could give us any idea on timing, so I understand the final plan has yet to be decided? And secondly, if you could let us know whether the start of the long-acting amylin with the BI collaboration will trigger a milestone? And then lastly, just on the data that's been disclosed for the HypoPal rescue pen, it's not been particularly detailed so far. And I just wonder, you've reported median time to treatment and success and the competitors have used the mean time. I just wonder if there's a reason for that?

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Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [24]

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Okay. Maybe I can take -- I can answer these 3 questions. If I start with the last one. So the way we define our primary endpoint for protocol, that was the median time, and we also used the observed mean, which means its -- which is a median. It's actually the time where we do the sampling. So it's the first time we have a 20 milligram per/dl to increase in plasma glucose. We could have used the mean time and the observed and the true means, then we would have had probably 9 minutes instead of 10 minutes on average on these results. So it's -- I would think it would only work to our benefit to actually change the way we would report the outcomes. But the way we design the studies and the way we think it's scientifically most thorough and clinical relevant is how we are presenting the data. But I would say, but even it would work to our benefit if we use the other ways to report the data. If you -- with regard to the amylin collaboration, there will not be a milestone associated with start-up Phase I, but there will be milestones once that program is getting into Phase II. And we have outstanding milestones of EUR 283 million. And as we also guide mid-single to low double-digit royalties on global sales. So -- but that will not be a milestone with the indication of Phase I with that Amylin. On the dual-hormone artificial pancreas, you're right, we reported the Phase II data in Q2, and we are in a very positive dialogue with FDA together with Beta Bionics discussing the Phase III program. And hope soon to be able to provide clear guidance to the market for this. We are excited as we have shared and see very good progress. The reason that we do not believe we can start the study before late next year, I think there are several factors. One is it takes time to finalize the protocol, get it submitted and finally approved and then also get contracts and the site up running, that typically takes some time. And the other thing, of course, is that you can say the drug, dasiglucagon has to be ready for Phase III. We believe we have a product that can go into Phase III, then the device also has to be ready to go into Phase III. So it's getting all these pieces together, which will take us into late next year. If Beta Bionics, they have communicated that they anticipate to start a study with the insulin-only function first, which we actually -- so -- and then we will start the dual-hormone together with Beta Bionics after that.

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Emmanuel Dulac, Zealand Pharma A/S - CEO & President [25]

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But rest assured that we are actually challenging these time lines all the time. And what we are providing here is actually a fairly aggressive time line based on our capacity, our knowledge of the market and the partnerships that we have to actually align with that. But we are going as fast as we can.

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Operator [26]

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(Operator Instructions) Our next question comes from the line of Peter Sehested.

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Peter Sehested, Handelsbanken Capital Markets AB, Research Division - Research Analyst [27]

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Yes, it's Peter from Handelsbanken. It relates to often asked question of the -- your pricing strategy for dasiglucagon because now you've introduced it to a potential fourth indication, where you could argue that pricing could be higher than for traditional rescue indication in Type 1 diabetes. So just a recap and add-on to what you've said before to pricing, please.

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Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [28]

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So maybe, Peter, I can just say one thing before Emmanuel talks. But I'm -- and one thing is, I think, it's extremely important to notice that it's 4 different product presentations we're discussing here. One is the rescue pen intended for single dose use when you have an emergency situation in auto-injector. For the dual-hormone, it's a cartridge that we developed for dual-hormone system for chronic treatment. For congenital hyperinsulinism is actually a chronic infusion. It's also a cartridge being used for chronic infusion. And then for the mini dose concept in a pen, it is a repeat use doable pen. So again, a fourth product presentation. So that, of course, creates optionalities here and it's also very different doses of the drug you would use considering the 0.6 milligram dose that you would use in a rescue setting. For the chronic use programs, it's -- it will be much more glucagon you would use over the course of a year, of course. Right, Emmanuel?

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Emmanuel Dulac, Zealand Pharma A/S - CEO & President [29]

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Yes. On top of that, I would add that these are different markets as well. So in the rescue market, for example, the price is set. I mean, there's already like existing products and so I think you have to align with what the market is already accepting. In the other, I mean, indications, these are totally blue oceans. So the next 3 indications, we would be first-in-class. And so we are then looking at the formulations, the dosing, the different presentation of the products. And at the same time, on top of that, I would say we add what we believe is actually the company philosophy that we will price responsibly for all these indications. So we are not there yet, and we're still actually working on these scenarios. But I can assure you that we are actually taking a very responsible approach to this pricing. I mean, today, I mean, there's a lot of sensitivity around that, and we are making -- we will make sure that we will provide a very good value for the products we price.

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Peter Sehested, Handelsbanken Capital Markets AB, Research Division - Research Analyst [30]

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Just a follow-up question to the dual agonist product. Should we expect to see any type of Phase I data? Or should we just hold on until we see the Phase II? And furthermore, will this Phase II study be a potential stepping stone for Phase III? Or should we see a Phase IIb study being started with A1c and weight outcomes as primarily before -- points before you move into Phase III?

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Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [31]

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I mean, it will be up to Boehringer to, of course, decide when to publish data. So we cannot comment on if we will see -- I'll be able to share Phase I data before we have the Phase II data. I think if you look at the Phase II study that they are starting here, its 410 patients. It's actually 6 different doses of the products that are being tested, and it's a 16-week study, which should provide enough data to move into Phase III. But again, it will ultimately be up to Boehringer to make these decisions. When we look at the -- such a study, or if I should look at a study like this, I would consider that a study that would allow to move directly into Phase III after the outcome if it turns out positively.

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Operator [32]

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(Operator Instructions) Okay. Sir, there are no further question at this time. Please continue.

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Lani Pollworth Morvan, Zealand Pharma A/S - IR & Communications Officer [33]

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Very good. Well, I think if there are no more questions, then we will go ahead and conclude today's call. Thank you all very much for joining and for your participation.

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Emmanuel Dulac, Zealand Pharma A/S - CEO & President [34]

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Thank you. Thank you, everyone.

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Operator [35]

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Okay. That does conclude your conference for today. Thank you for participating. You may all disconnect.