U.S. Markets open in 3 hrs 49 mins

Edited Transcript of ZEAL.CO earnings conference call or presentation 15-Aug-19 2:00pm GMT

Half Year 2019 Zealand Pharma A/S Earnings Call

Aug 19, 2019 (Thomson StreetEvents) -- Edited Transcript of Zealand Pharma A/S earnings conference call or presentation Thursday, August 15, 2019 at 2:00:00pm GMT

TEXT version of Transcript

================================================================================

Corporate Participants

================================================================================

* 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

* Marino Garcia

Zealand Pharma A/S - SVP of Corporate & Business Development

================================================================================

Conference Call Participants

================================================================================

* Alan Carr

Needham & Company, LLC, Research Division - Senior Analyst

* David Neil Lebowitz

Morgan Stanley, Research Division - VP

* Graig Suvannavejh

Goldman Sachs Group Inc., Research Division - Executive Director & Senior Equity Research Analyst

* Lucy-Emma Mary Sarah Codrington-Bartlett

Jefferies LLC, Research Division - Equity Analyst

* Peter Sehested

Handelsbanken Capital Markets AB, Research Division - Research Analyst

* Thomas Schultz Bowers

Danske Bank Markets Equity Research - Analyst

================================================================================

Presentation

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

Ladies and gentlemen, thank you for standing by, and welcome to the Zealand Pharma Results for the First Half of 2019 Conference Call. (Operator Instructions)

I must advise you that this conference is being recorded today, Thursday, the 15th of August 2019. I would now like to hand the conference over to your first speaker today, Lani Morvan, Head of Investor Relations and Communications. Thank you. Please, go ahead.

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Thank you, and welcome to Zealand Pharma's Conference Call for the First Half of Fiscal Year 2019. Leading today's call are Zealand's CEO, Emmanuel Dulac; and Chief Medical and Development Officer, Adam Steensberg. Emmanuel will provide financial highlights for the first half of the year as well as business highlights from the second quarter and the period thereafter. Adam will follow with highlights from our research and development programs. After their prepared remarks, we will open to take your questions. And joining for the Q&A will be the rest of the full corporate management team.

You can find the company announcement containing the first half interim report and additional supporting information on our corporate website at zealandpharma.com. As a company headquartered in Denmark, our financials are reported in Danish crowns, also referred to as kroner. Key figures may have been converted to 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 unless as required by law. Please refer to recent filings for a more complete picture of risks and other factors.

And as we advance to Page 2, I will now turn the call over to Emmanuel.

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Thank you, Lani, and thanks to everyone for joining the call today.

In the second quarter of 2019, we continued strong execution across all our company objectives. For me, it's been now 4 exciting and busy months since starting at Zealand. I remain honored by the opportunity to grow this leading biotech and impressive team with a strong track record, and I look forward to building upon the relationship that we have established with our key stakeholders and investors.

Turning to Page 3. Over the last 20 years, Zealand Pharma has proven that our peptide therapeutics platform and know-how is providing us the competitive advantage on the discovery side. We have one of the most productive and promising platform in biotech.

Over the last 10 years, we have proven that we can take multiple programs through the clinics and execute on them according to industry benchmarks. To harvest the benefits of these years of investments and efforts, we are now preparing to take our own products through registration and commercialization. We have retained the full commercial rights for our late-stage programs. And assuming we get approvals for glepaglutide and dasiglucagon in all indications, we are contemplating 4 launches in 3 years, starting in 2021.

After thorough assessment of market potential and partnerships, we concluded that building our own commercial presence in the U.S. to market all of the products coming from our fully owned programs is the best way for Zealand Pharma to maximize the value of our company and grow our assets.

Of course right now, all eyes are under dasiglucagon HypoPal rescue pen. We have strong reasons to be encouraged by -- about dasiglucagon based on the consistent promising results that we have seen from the rescue pen throughout the clinical studies as well as from our older programs with dasiglucagon. The unmet medical need and expansion potential of our hypoglycemia rescue market is further validated by the recent approval of the nasal glucagon from Lilly.

The dasiglucagon rescue pen is now expected to be the first product commercialized by our own organization. If all indications are approved as planned, we will enter the market with the rescue pen, gain further momentum with dasiglucagon to treat CHI and culminate our efforts with the significant potential of transforming lives with diabetes, with use of the dual-hormone artificial pancreas.

To fulfill our ambition of becoming a fully integrated biotech company that we have an added strategic decision to realize the full value of the combined dasiglucagon opportunity, we are accelerating the buildup of our U.S. operations and preparing for transition into a commercial stage company in 2020. This is an exciting and pivotal time for our company history. We will update you in the coming quarters on our commercial readiness assets in much more detail.

Moving ahead to Page 4. You will see key financial metrics and business insights from the first half of 2019, beginning with financial results through the period ending June 30. Zealand recognized just under DKK 20 million in revenue attributable to our agreement with Alexion. We have net operating expenses of DKK 292 million. We ended the half with a net operating loss of DKK 272 million.

We are taking the opportunity to adjust our guidance. Our net operating expenses for the year now expected to be within DKK 580 million to DKK 600 million, changed from previous DKK 550 million, DKK 570 million. Changing guidance is mainly related to strong clinical progress resulting in additional spend on ZP7570 and dasiglucagon CHI programs as well as accelerated buildup in the U.S. to prepare for commercialization of the dasiglucagon HypoPal rescue pen.

For business highlights, we saw overall strong progress and solid results made across our pipeline, and Adam will go through the details shortly. I will simply point to the encouraging results delivered by 2 dasiglucagon program and the expanded development of potential novel treatment for short bowel syndrome by advancing both glepaglutide and the ZP7570 in clinical studies.

This leads me to discuss further our organization on Page 5. We are now recruiting for 2 of our top management position. The candidate choices for CFO has been narrowed to finalists. Recruitment for a CSO has been initiated as Andy Parker will be departing as Zealand's Chief Scientific Officer. During his time at Zealand -- and he has contributed greatly to advancing our peptide platform and research organization. And on behalf of all Zealand Pharma, I want to thank Andy for his hard work and wish him the best in his next endeavor.

In line with the progress of our pipeline, our organization has grown by 16% this year at 172 employees. We have more resource to support growth in both research and development while continuing to be a lean and agile organization.

This quarter, I have accelerated the first steps for building commercial operations in the U.S. We are recruiting for the top leadership roles and started executing on our medical and commercial launch strategy. I look forward to welcoming new team members into these critical roles and to establishing our footprint in the most important market for potential products.

On Page 6, we have a visual for our financial position, which remains strong. The chart on the left has been adjusted to reflect the update guidance on net operating expenses, which remains in line with our ambitions to bring several fully owned programs to the market. And on the right, you can see that our cash position also remains strong, with about DKK 1.14 billion after the first half of the year.

With Page 7, I ask that you please hold any questions until the Q&A later during the call. And I will now ask Adam to update on our development programs. Adam?

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Thank you, Emmanuel.

So Page 8 is an overview of Zealand's extremely robust pipeline. Each of the 4 late-stage programs will be covered on the next slides, but notably, there is an advancement of ZP7570 into clinical testing as well as a completion of Phase II for the dual-hormone pump with dasiglucagon in this last quarter.

The early-stage clinical programs with Boehringer Ingelheim continue without changes. We expect BI to conclude, this year, Phase I for their once-weekly GLP-1 glucagon agonist for treatment of obesity and diabetes and we further await their decision regarding Phase I initiation for another once-weekly amylin analog, also for the treatment of obesity and diabetes. The work has begun with Alexion on the complement inhibitor program and is progressing according to plans.

So on Page 9, glepaglutide is our long-acting GLP-2 analog being developed for treatment of short bowel syndrome in an auto-injector with potential for convenient weekly administration. In 2018, we initiated a pivotal Phase III study, which remains on track to announce results in 2020. We look forward to the continued steady enrollment of patients throughout the remainder of the year.

Moving to Page 10. Dasiglucagon is a potential first-in-class stable glucagon analog invented and developed by Zealand in a ready-to-use HypoPal rescue pen for easy, fast and effective treatment of severe hypoglycemia. Last quarter, we reported top line results from a confirmatory Phase III study with median time to glucose recovery of only 10 minutes from injection. This study was important because it was conducted with the auto-injector that is intended for the market, and it demonstrated similar results to the prefilled syringe started -- as used in previous studies.

Results are expected in September from the ongoing Phase III pediatric trial using the same dose as administrated to adults and thus, we remain on track for submitting the NDA to the U.S. FDA in early 2020.

Please turn to Page 11. In June, we were extremely pleased to see the results from the Phase II trial in patients with Type 1 diabetes with dasiglucagon in the iLet bionic pancreas. This was the first ever outpatient home-use clinical study of a true dual-hormone artificial pancreas using both insulin and dasiglucagon, and we believe that this study demonstrated unprecedented glycemic control. We are excited by the disruptive innovation and believe it holds the potential to transform the lives of people burdened with Type 1 diabetes. As a next step in the development, we look forward to the pivotal Phase III trial that is set to begin in 2020.

Page 12 provides an update on our dasiglucagon program focused on treating congenital hyperinsulinism. A child with CHI is formed with a genetic effect in the pancreas, causing continuous high levels of insulin and thus, persistent episodes of dangerous low blood glucose. The burden of this disease on the children and their families is immense, and they must constantly battle against the low blood glucose with, e.g., nasogastric feeding and frequent feedings during sleep, et cetera. Therefore, we were very pleased to see, during the summer, increased traction in the recruitment into our first Phase III study, evaluating dasiglucagon's potential to prevent the episodes of hypoglycemia in CHI children aged 3 months to 12 years. And we now expect to have the results of this study in 2020.

The second Phase III trial will enroll 12 children with CHI, some newborn, up to 1 year, and that study remains on track for initiation later this year.

Now on Page 13, I will return the call to Emmanuel for his concluding remarks.

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Thank you, Adam, for this overview and congratulations for the progress. Very good to see the programs are advancing as planned.

Page 14 shows the objectives for 2019. Halfway through the year and with the updates just provided, you can see that Zealand Pharma is well on track to deliver.

On Page 15 shows the accomplishments already made in 2019 and the upcoming news items we anticipate for the rest of the year. We believe there are significant opportunities on the horizon to create further value for our shareholders, and Zealand continues on a clear path for 2019. And we are remaining -- we all remain enthusiastic about the progress being made.

--------------------------------------------------------------------------------

Lani Pollworth Morvan, Zealand Pharma A/S - IR & Communications Officer [6]

--------------------------------------------------------------------------------

Thank you, Emmanuel and Adam. This concludes our prepared remarks. So thank you all for your attention thus far. Tom, we're now ready to take questions, so please open the line.

================================================================================

Questions and Answers

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

(Operator Instructions) The first one comes from the line of David Lebowitz.

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

A competitive product, Baqsimi, for -- with a nasal treatment for hypoglycemia was just approved. I guess how do you see the competitive dynamic shifting up in the space given the convenience that a nasal approach might offer?

--------------------------------------------------------------------------------

Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [3]

--------------------------------------------------------------------------------

Yes. Well, I think -- I mean, first of all, I think it's a very good news for patients that a new drug is approved in this field. It shows as well the large unmet medical need that several companies are coming up with, with solutions for these patients.

I think the -- as you know, the price, it's kind of set in this market already from preexisting treatments. So I think the pricing of Baqsimi doesn't necessary change anything for the rest of us.

We still believe that there were actually no real promotion for these products in the past, so now having an active compound and injecting in newness in this market will actually really help transform this market. There's a vast potential as patients are not necessarily equipping themselves with these solutions. And because there would be several solutions, there will be actually potential to differentiation between the products. We believe that speed of response will be a very major differentiation point in the future.

--------------------------------------------------------------------------------

Operator [4]

--------------------------------------------------------------------------------

And the next question comes from the line of Graig Suvannavejh.

--------------------------------------------------------------------------------

Graig Suvannavejh, Goldman Sachs Group Inc., Research Division - Executive Director & Senior Equity Research Analyst [5]

--------------------------------------------------------------------------------

Congrats on the progress. I've got a few questions, if you don't mind. My first question just has to do with your decision to now go ahead and formally launch dasiglucagon HypoPal as well as the rest of the franchise. Could you just maybe give us a little bit more color around that decision? And what was the partnership interest that was generated around the product and in those discussions? And was that the reason why you decided to launch on your own? And then I've got a few follow-ups.

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Yes. No that's good, and I will try to answer all these in one answer actually. But first of all, we saw, earlier this year, fantastic results from the dual-hormone pump. The long-term prospects of -- in the dasiglucagon franchise significantly increased based on these results.

So since I started -- after conducting a thorough assessment of market potential and partnerships, we came to the conclusion that building our own commercial presence in the U.S. is the best way to maximize the value of our company and grow all of our assets. So while we remain open to dialogue with partners and especially, for example, rest of the world, we are preparing to build and launch our assets, which actually fulfills, on one side, the -- our long-term strategy to become like a fully integrated research, development and commercial company as well as maximizing the value of our assets. Does that answer your question?

--------------------------------------------------------------------------------

Graig Suvannavejh, Goldman Sachs Group Inc., Research Division - Executive Director & Senior Equity Research Analyst [7]

--------------------------------------------------------------------------------

Yes. It does. Also, just on the topic of business development, the company has been fairly vocal about business development opportunities. And obviously, it's hard to predict the outcome of any discussions you're having. But my question is are you still expecting or hoping for additional business development activities in the second half of the year. And are they more around out-licensing or in-licensing opportunities?

--------------------------------------------------------------------------------

Emmanuel Dulac, Zealand Pharma A/S - CEO & President [8]

--------------------------------------------------------------------------------

That's a great question. I am going to pass actually this question to our Chief Business Officer, Marino Garcia.

--------------------------------------------------------------------------------

Marino Garcia, Zealand Pharma A/S - SVP of Corporate & Business Development [9]

--------------------------------------------------------------------------------

As you mentioned -- I mean, it's always difficult to predict what transactions you're working on may actually come to fruition and get announced. But what I am confident or comfortable saying is that we have multiple initiatives going on, both from a licensing and acquisitions, in- and out-licensing, I should say, as well as potential acquisitions to enhance our pipeline. And we're looking at other options as well to help us with our ongoing strategy that Emmanuel has highlighted, for example, in building in the U.S. so that we have -- the mandate is very clear. The support from Emmanuel and the executives and the Board is very clear, and we hope to have some announcements, some more news in the coming weeks, months ahead.

--------------------------------------------------------------------------------

Graig Suvannavejh, Goldman Sachs Group Inc., Research Division - Executive Director & Senior Equity Research Analyst [10]

--------------------------------------------------------------------------------

Okay. And then maybe a last question before maybe I jump back into the queue. I'm intrigued about the once-weekly GLP-1 glucagon combination as well as the once-weekly amylin analog for obesity and type 2 diabetes. And I'm trying to just get a better sense around that opportunity, especially relative to potential positioning versus, say, like an oral semaglutide.

--------------------------------------------------------------------------------

Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [11]

--------------------------------------------------------------------------------

Thanks, Graig. This is Adam. Maybe I can put a little color on that. So far, of course, from a CDC point of view, we only have preclinical data to build our assumptions around and then maybe you can add to that, that other companies will also be pursuing similar targets.

What we have seen, both at the GLP-1 and the glucagon and actually also the amylin analog, is weight loss potential that exceeds what we have otherwise seen with other compounds. So very, very promising on that end, and then at the same time, providing very good glycemic control.

The modality is as such, and especially for the Tier 1 glucagon, I think it's -- from a scientific point of view, also very attractive in the sense that it targets directly the liver and the [concentrations] in the liver, which is a major problem for these patients.

Of course, we are in a dialogue with BI, and what we can say is that they are completely committed to these programs and see a large potential, regardless of the oral compounds that you mentioned. And I think what we are looking at here is molecules that will provide efficacy beyond what we are seeing in clinical development from competitors so far. So we look very much forward to the next steps and BI making decisions on the next steps, and of course, we'll inform the market when we have that information.

--------------------------------------------------------------------------------

Operator [12]

--------------------------------------------------------------------------------

The next question comes from the line of Alan Carr.

--------------------------------------------------------------------------------

Alan Carr, Needham & Company, LLC, Research Division - Senior Analyst [13]

--------------------------------------------------------------------------------

From around the -- your plans to close your commercial operations, is this something that's focused just in the U.S.? Or do you plan to also build in Europe? You're going to be expanding effort in Europe, too.

And then is it -- coming back to a question earlier, is this more of -- the decision more of a function in the change in management or in strategy? Or is it issues with finding a potential partner?

And then also, if you can talk about what's next for the dual-pump program for dasiglucagon? Do you need to meet with the FDA for a pre-Phase III meeting? Where does that stand? And where do you think this -- the nature of the scale and nature of this Phase III is going to be?

--------------------------------------------------------------------------------

Emmanuel Dulac, Zealand Pharma A/S - CEO & President [14]

--------------------------------------------------------------------------------

Thank you, Alan. I'm going to respond to the first one. I'll pass the next 2 to Adam. But on the first one, we are, right now, only focusing our attention on the U.S. market in deploying our commercial operations in the U.S. At the same time, especially on the rare disease side, we will actually try to make our product available on a per-patient basis or even in a per-country basis if we find an avenue there. But the commercial deployment of patient services, sales force, medical affair, market access, people will be mostly in the U.S. And the goal is to support rest of the world on an opportunity basis from people that we have here based in Copenhagen.

And for the next 2 questions, I'm going to give them to Adam.

--------------------------------------------------------------------------------

Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [15]

--------------------------------------------------------------------------------

Okay. Thanks, Emmanuel. Maybe on the first one, I think -- and you asked about the -- if the -- kind of the focus on balancing the HypoPal also, the reasons behind that. And perhaps, Emmanuel, you will follow up again after I just contribute a few things here. But I think, as Emmanuel also put it, we have some fantastic data with the dual-hormone artificial pancreas release in June, just before ADA, which in our mind, demonstrates the potential of using dasiglucagon in dual-hormone pumps to really achieve something that has never been achieved before in Type 1 diabetes, and that is close to full control without having user engagement all the time.

So with those data set, you can say the confidence that we have had in the dual hormone opportunity for some time just grew even larger. And of course, in this context, we -- the value of the full franchise of dasiglucagon goes far beyond the HypoPal rescue pen. So that, of course, changed a little bit the dynamics of how we look at this. And then as Emmanuel also said, when he came in with his background from U.S., I mean, we, of course, had the chance to look at the overall portfolio. Before maybe -- Emmanuel will provide further take on this. I would just -- in reply to your last question, I don't know, the next steps that we have. So already last year, we had a very positive interaction with the FDA, and we have been writing, as we have also communicated to the market, that they actually do consider both us and our partner, Beta Bionics, ready to engage in Phase III development.

Since then, we have conducted a study we just discussed. And furthermore, Beta Bionics has raised a significant amount of funds so they're fully funded to actually bring that product, the dual-hormone artificial pancreas to the late -- last stages of development and also engage in commercialization and have a clear part to that.

Our next steps with the FDA is that we will have a meeting with them to discuss the Phase III program. We actually believe it will be a program that is limited, you can say, in size compared to what you would normally expect for these kind of indications. But we would not comment on the complete detail before we have had this meeting with the FDA. But in the sense of size of the study, we are actually very, very positive. Some of the aspects of the study has already been discussed, but we would like to have it a little bit more firm agreed with the FDA before we put more flavor into this.

What I will say is that we -- both teams, both the Beta Bionics team and the Zealand team, is fully engaged and fully in preparation mode to get the Phase III study started next year. So we are working diligently towards that milestone, and we will have meetings with FDA later this year to finalize the plans.

Emmanuel, do you want to add more to that?

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Alan, do you need more information about the franchise? Because again, I think dasiglucagon is seen as a franchise. It's not -- even though we have the rescue pen and the CHI and the dual-hormone pump, it's -- I would say, if you look at it from [their] view, and it's a Type 1 diabetic market patient group, in which there are subgroups in it -- and so we believe that there is real synergies that's taking this approach as a whole -- as a franchise. And we will benefit a lot from the experience of marketing and commercializing the first 2 indications before bringing the dual-hormone pump on the basis of the latest results. We definitely wanted to retain.

--------------------------------------------------------------------------------

Alan Carr, Needham & Company, LLC, Research Division - Senior Analyst [17]

--------------------------------------------------------------------------------

Okay. So with respect to the dual pump, will you be making an announcement after you've confirmed Phase III trial design? Or will we need to wait until you start the trial next year?

--------------------------------------------------------------------------------

Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [18]

--------------------------------------------------------------------------------

I'm sure we will talk about -- we will be more specific once we have had the meeting, and it is a meeting that we have planned, as we've also said before. And we will make firm announcements. Maybe that is to be seen if it's going to be announcement or just part of the quarterly update. But we definitely plan on being launched as planned on this once we have had the meeting with the FDA.

--------------------------------------------------------------------------------

Operator [19]

--------------------------------------------------------------------------------

And the next question comes from the line of Thomas Bowers from Danske Bank.

--------------------------------------------------------------------------------

Thomas Schultz Bowers, Danske Bank Markets Equity Research - Analyst [20]

--------------------------------------------------------------------------------

A lot of follow-up questions from me. Just to get a clear idea on how you think of commercialization in Europe. Did I understand correctly that you will not build any sales force or anything in Europe? And how should we see or -- are you not even going to file for approvals for glepa in Europe? Or will you -- so basically are you planning on doing in an inpatient program and then partner the program for rest of world and Europe? And I guess that also goes for the rescue pen.

And then secondly, I mean what's your exact plans on when you enter the U.S. market? I mean for me, for rescue pen, it does reflect that you need quite a significant sales force. So how do you plan to attack and address the U.S. market? I mean you have just DKK 1 billion in cash, so I guess it is a quite large investment that you need to do for 2021. So are you still in negotiations for doing some out-licensing outside the U.S. that could bolster the balance sheet? Or how should we see that?

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Thank you, Thomas. So regarding your first questions about the Europe commercial presence, you're right. But it's not Europe. It's rest of the world. It's wider than Europe. So we will not deploy commercial presence in rest of the world per se. But we will actually try to provide access through the existing channels and there's a lot actually especially in rare disease field but not for the dasiglucagon approach. What we are, and we stated too as well, we remain open to dialogue in terms of partnerships for rest of the world. And so I think this could be -- I mean a matter for updates in the future. We are definitely going to file in Europe in the -- [our dossier], so we will do that as the next step. But again, we're taking the U.S. first approach.

And related to your financing questions, we are continuously evaluating financial options to support the ambition and our ambitions and our development plan. If the need arise for additional funding, we will actually formally announce such opportunity to the market. Of course, we're not guiding on it, but you can be sure that with the ambition plan we have, we will have to go back to the market one day. But we have 2 years actually of financing right now in the bank, so we're in a very comfortable situation. And that should support us easily for the next 2 years.

--------------------------------------------------------------------------------

Thomas Schultz Bowers, Danske Bank Markets Equity Research - Analyst [22]

--------------------------------------------------------------------------------

Okay. And just on what size sales force do you think you need for the U.S. market to cover that or maybe also going to take some higher cost maybe.

--------------------------------------------------------------------------------

Emmanuel Dulac, Zealand Pharma A/S - CEO & President [23]

--------------------------------------------------------------------------------

Yes. So again, we don't have -- we don't communicate firm numbers right now. But I can tell you that when we look at the dasiglucagon rescue pen and CHI and even the dual-hormone pump, we're talking about a market today that doesn't really exist in terms of active promotion. It's in very big potential markets. We see diabetes, but at the same time, we're not competing against the insulin. So we have to look at this market in a way that it's, I would say, a niche within a very large market. And we have -- we're going to take ways to actually size our efforts accordingly to maximizing the return on investments for this opportunity. So we don't have to compete against all the insulin makers. We have to actually appropriately position our products in the largest opportunity areas.

And just to guide you, one, if you look right now at this market, which again hasn't developed as a promoted market but has naturally developed, around 70% of the users of existing kits today are kids. So it's family with Type 1 diabetic kids who are buying around 70% of these kits. So you could actually definitely launch within like a very niche approach. And it actually aligns very well with our CHI indication that is coming behind because CHI is again is in this field of pediatric diabetes and endocrinology. And I think it prepares us really well for the dual-hormone pump, which is where we said over and over that's where we really want to go.

So I would only guide the market to actually say that basically, we will not provide revenue and targets, and we have to actually still define what type of KPIs we will provide the market with. But I think I would say that I would lower your short-term expectation and I would increase your long-term expectations on the company based on the dual-hormone pump potential.

--------------------------------------------------------------------------------

Operator [24]

--------------------------------------------------------------------------------

And the next question comes from the line of Lucy Codrington of Jefferies.

--------------------------------------------------------------------------------

Lucy-Emma Mary Sarah Codrington-Bartlett, Jefferies LLC, Research Division - Equity Analyst [25]

--------------------------------------------------------------------------------

Just a couple. I just wondered if you could comment a bit more on the rate of recruitment for the glepaglutide trial and the dasiglucagon CHI trial. Are you happy with the current rate? And should we, therefore, be thinking about data towards the second half of next year for those trials?

And then I appreciate it's a competitor product, but I just wonder for the nasal approach for the glucagon rescue, do you know if the Lilly device requires the patient to actively inhale or is it a case of just squirting the glucagon up the patient's nose by a, I guess, somebody who's with the patient?

--------------------------------------------------------------------------------

Emmanuel Dulac, Zealand Pharma A/S - CEO & President [26]

--------------------------------------------------------------------------------

Yes. Lucy, I think Adam is the best equipped to respond to you.

--------------------------------------------------------------------------------

Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [27]

--------------------------------------------------------------------------------

So the last question first maybe. Our understanding is that it will not require the patients to inhale, that you just have to spray it up into the nose, the Lilly device. So that's that answer. And with regard to recruitment, if I start with CHI, which is actually where we have seen a significant ramp-up in recruitment and also screening this summer, we actually -- it's also the first time, as you noticed, that we actually start to guide more firmly on results in 2020. So here we have managed to have all the centers running now that are participating in this study, and we see a lot of excitement. And of course, one thing is the randomized number of patients, but we also have, more importantly, the number of screened patients who are anticipated to enter the study soon. So that's where we have, I would say, a much higher confidence in the speed of recruitment that we have just a quarter ago.

And glepaglutide is a little bit similar story in the sense that we have now managed to get most, if not all, of the sites activated over the summer. We also have a number of patients in the screening. And it's a study which takes -- it takes actually up to a few months from screening until we randomize because they run in phases and so on. So here we are also very confident that we will reach the target that we are guiding on with regard to recruitment and expect the numbers to grow, as we stated here, over the next month. Definitely, and I think that's also what we guided last quarter. The results would be expected in the second half of 2020 and not the first because it's a 6-month study.

--------------------------------------------------------------------------------

Operator [28]

--------------------------------------------------------------------------------

And the next question comes from the line of Peter Sehested from Handelsbanken.

--------------------------------------------------------------------------------

Peter Sehested, Handelsbanken Capital Markets AB, Research Division - Research Analyst [29]

--------------------------------------------------------------------------------

It's Peter from Handelsbanken. I have 4 and I apologize if they have been asked before. I've been in and out of the conference call. The first one...

--------------------------------------------------------------------------------

Emmanuel Dulac, Zealand Pharma A/S - CEO & President [30]

--------------------------------------------------------------------------------

Peter, can you speak closer to the phone? We can't hear you.

--------------------------------------------------------------------------------

Peter Sehested, Handelsbanken Capital Markets AB, Research Division - Research Analyst [31]

--------------------------------------------------------------------------------

Yes. Is it better now?

--------------------------------------------------------------------------------

Emmanuel Dulac, Zealand Pharma A/S - CEO & President [32]

--------------------------------------------------------------------------------

Yes. It's slightly better, yes.

--------------------------------------------------------------------------------

Peter Sehested, Handelsbanken Capital Markets AB, Research Division - Research Analyst [33]

--------------------------------------------------------------------------------

Okay. So my first question relates to your backup compound for short bowel syndrome, ZP7570. Could you give us an overview of what kind of data you would have on that compound when you announce the Phase III data for glepaglutide? That is my first question.

My second question relates to pricing for the year for glucagon in the dual-hormone pump. How -- what is your strategy for demonstrating the added value of glucagon in that pump relative to payer discussions? That is my third question -- sorry, second question.

And my third question relates to peak sales prognosis for dasiglucagon in the rescue pen setting.

And finally, my fourth question relates to your commercial infrastructure in the U.S. I guess you need 2 different infrastructure setups to market dasiglucagon and glepaglutide. Could you be so kind as just to briefly highlight what kind of -- might not give some guidance on numbers but just to give us a sense where is the overlap here? And where do you need some different, say, resources to market those 2 products?

--------------------------------------------------------------------------------

Adam Steensberg, Zealand Pharma A/S - Executive VP and Chief Medical & Development Officer [34]

--------------------------------------------------------------------------------

Thank you, Peter. Maybe -- this is Adam. I can start by answering the first 2 questions and then -- I think your first question was regarding our GLP-1/GLP-2 compound, ZP7570, also in development for short bowel syndrome. What data would we have available once we have the Phase III data from glepaglutide. So we initiated a Phase I study, which is a classical study in helping [volunteers'] safety and tolerability dose escalation study. And here in June and across we expect to conclude that and then also hopefully get into the multiple ascending dose so have the full safety Phase I studies concluded at a time when we have the Phase III data. And we also -- I mean then based on these data and how the dose escalation goes, I mean we, as a company, will have to discuss when and how to do the Phase II and how it relates to the glepa Phase III outcome.

On the (inaudible) versus insulin only, I think we have only released top line results from the study that we announced in June. But if you just look there into some of the key glycemic parameters, then it was a short-term study, but one of the main things I would focus on is that in that study, if you just kind of model how that would look in a longer-term study, then we could actually get 90% of the subjects on the dual-hormone system into the range of glycemic control that is recommended by American Diabetes Association versus only 50% in the insulin-only system, which is also a semi-automated system.

So I mean this is a system that actually allows patients to achieve the glycemic levels that ADA recommends. And we did that with actually having lower incidence of hypoglycemia and also half the number of dangerous low blood glucose. So you can see -- so you achieve this fantastic glycemic result with less hypoglycemia. And because it's a dual-hormone system, it will also require less efforts by the patients and the families because the system itself corrects the dose. In the insulin-only systems, patients will have to snack and intervene in order to correct the dose, which will happen once -- now and again, in the insulin-only system.

So that's why we are super excited. It's not just a question about getting into target. It's actually a question about getting into target with less efforts and much, much less hypoglycemia. So we see this as a truly disruptive technology, which would actually place the opportunity in a very different level than the existing systems, which all provide, I will say, great clinical results in clinical studies. But once you release the products into real life, it's such a struggle for patients to be on them, also as seen by real-life evidence data.

--------------------------------------------------------------------------------

Emmanuel Dulac, Zealand Pharma A/S - CEO & President [35]

--------------------------------------------------------------------------------

Yes. And I will take your last 2 questions, Peter. You were talking about the sales prognosis for the rescue pen. I just wanted to point you to the size of the market today. Today, there is about 1 million kits, existing kits sold annually in the U.S., and there's around 7.2 million insulin-dependent patients. The predictions from various analysts and as well from Lilly and from other companies is that this market will likely triple and reach around 1 billion in the coming years simply because there will be actually several products that will offer valuable solutions for patients, whereas versus the existing kits.

There will be active promotion from potentially 3 companies in this field, and there will be actually product differentiation between these products. So again, we believe we have a compound that has a very strong differentiation profile by being really fast and effective. And so I won't guide you on the sales prognosis for our own rescue pen, but we think we have potentially a drug that could establish standard of care.

On the fourth question, which is your sales force structure in the U.S. There are synergies between the different indications. One of the big synergy I want to point out is for rare disease, you had to deploy a very active and elaborated patient services team and patient service group. And I think it would be very innovative to use some of these experts to help with very specific cases of diabetic management, whether it's the rescue pen or the dual-hormone pump. But I think it's not used right now because there's a very -- there's somewhat a separation between rare disease management, the way it's being done, and rest of the market in U.S. market. But I think there's a big value in learning and trying to implement best practice from one side to the other.

Again, I told you there will be synergies as well in the cold plan. I mean some of these experts are crossing over. But ultimately, the bulk of the sales force will be deployed in terms of the number of people deployed on the diabetes side. They don't have the same profile as the rare disease folks there. You don't need experts like you need in rare disease. But in rare disease, you can achieve very good promotional efforts in the U.S. with a handful number of people. You don't need an army. And you can take a very targeted approach based on concentration of patients in key centers, excellent centers. We have a product on the market in SBS. So there's a lot of information -- market information available right now knowing where these patients are and where these key centers are. So I think we can build from that knowledge and get to market really fast. Again, assuming we have a differentiated product and with a superior profile. Does it answer your question?

--------------------------------------------------------------------------------

Peter Sehested, Handelsbanken Capital Markets AB, Research Division - Research Analyst [36]

--------------------------------------------------------------------------------

Yes.

--------------------------------------------------------------------------------

Operator [37]

--------------------------------------------------------------------------------

And we have no further questions at this time. You may continue.

--------------------------------------------------------------------------------

Lani Pollworth Morvan, Zealand Pharma A/S - IR & Communications Officer [38]

--------------------------------------------------------------------------------

Thank you, everybody, for participating and joining us today. If there are no more questions, I think we will go ahead and end the call.

--------------------------------------------------------------------------------

Emmanuel Dulac, Zealand Pharma A/S - CEO & President [39]

--------------------------------------------------------------------------------

Thank you, everyone. Thank you for participating.

--------------------------------------------------------------------------------

Operator [40]

--------------------------------------------------------------------------------

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