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Zealand Pharma A/S (ZEAL)
Q3 2019 Earnings Call
Nov 14, 2019, 10:00 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Ladies and gentlemen, thank you for standing by and welcome to the Zealand Pharma Results for the Third Quarter of 2019 Conference Call. [Operator Instructions] After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] I must advise you 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.
Lani Morvan -- Investor Relations and Communication
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 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 Moller, 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 Investor section of our website at zealandpharma.com. As a company headquartered in Denmark, our financials are reported in Danish krone, often referred to as kroner. Key figures may have been converted to US 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.
Emmanuel Dulac -- President and Chief Executive Officer
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 strengths was reinforced with a V4 [Phonetic] 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 vast opportunities 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 toward our ambition to become a fully integrated biotech with medical and commercial operations. We are rapidly preparing to take our home products through registration and commercialization with four exciting launches planned in the next four years. The first anticipated to start in 2021.
Moving ahead to Page 4, you will see business highlights through Q3 and in the period after. We were thrilled with the results from the pediatric study in the Phase 3 clinical programs for dasiglucagon to treat hypoglycemia. It was a positive note on which we concluded the clinical program and turned fully focused on preparing the NDA to submit early next year. The potential of dasiglucagon continues to grow. A Phase 2 proof of concept trial was initiated to explore dasiglucagon's potential to treat patients experiencing at hypoglycemic events following bariatric surgery. The study will further examine the potential of mini-doses of dasiglucagon and then we'll 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 assets, strategically expanding our pipeline with an alpha-4-beta-7 integrin Inhibitor with potential for overall delivery. We strengthened our financial position with a significant private placements from Van Herk Investments. They had been a long time investor in Zealand and the additional DKK560 million investment showed their continued support and validation of our Company.
Finally, has been wonderful to have our new CFO, Matt Dallas on-board since October. Matt is a very experienced seasoned biotech CFO. It is in the Boston area where we are establishing our US 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 our current transformation and future potential. We can see actual transformation as the construction work to install our laboratories continues. While inside the walls, there is definite positive support for Zealand's path ahead.
Slide -- Page 5 summarize the acquisition of Encycle and the lead is set 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 [Indecipherable] into our peptide platform. We appreciate that entities like Encycle recognize Zealand's expertise and capabilities in peptide research and developments.
Finally, the financials on this acquisition in a derisk 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 US. Looking at the year ahead, we can pinpoint several delivery goals that are important for our launch readiness. Early next year, we will open a facility in Boston. Boston is a hub for biotech innovation. We have been recruiting in this area already to fill the top leadership positions for our US 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 US presence, to launch dasiglucagon rescue pen. But it is important to realize that we are finding the teams who will launch three other potential treatments soon after the rescue pen.
Zealand has an ambitious plan during the next four years, and we are well on our way to ensuring successful operations in our largest commercial markets.
Advancing to Page 7, I will turn the call over to our CFO, Matt Dallas to review financial results throughout the quarter, the third quarter. Welcome, Matt.
Matt Dallas -- Senior Vice President and Chief Financial Officer
Thanks Emmanuel. Through the first nine months of 2019, Zealand reported net operating expenses of DKK431.5 million. Our net operating result was a loss of DKK402.1 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 DKK580 million to DKK600 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 DKK1.5 billion or $225 million. This includes funding from 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.
Adam Steensberg -- Executive Vice President, Chief Medical and Development Officer
Thanks, Matt. So on Page 10, you will 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 administrations 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 site initiations in US and UK 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 of those results from the study will be pushed into the first half of 2021. We remain confident toward achieving our target for an NDA submission in 2021.
On ZP7570, we are seeing very good clinical progress. Based on the observed safety and tolerability of the single-ascending Phase 1 trial that was initiated in June this year, we are happy to announce that we now plan to initiate the Phase 1b multiple-ascending dose safety and tolerability trial early next year. ZP7570 is 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 3 trial and thereby completed the full Phase 3 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 concluding, 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 beyond 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 2 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 are working closely with FDA to plan the pivotal Phase 3 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 hyperinsulism. In our first Phase 3 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 expected in 2020. The second Phase 3 trial will enroll 12 CHI children from newborns up to one-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 2 clinical proof of concept dose finding trial in 2020.
On Page 14, we 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 is no approved treatment option for these estimated 6,000 patients in the US, who suffer 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, which have one 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 2 study next year, and to continue exploring this as a fourth [Phonetic] treatment modality for dasiglucagon.
Moving to Page 15. The final R&D program updates for this quarter are with our partner, Boehringer Ingelheim. For the GLP-1/glucagon dual agonist, we announced in early Q3 that Boehringer decided to advance this target to Phase 2, based on positive outcome in Phase 1. The Phase 2 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 this study is to explore absolute 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 1 initiation into 2020.
Going to Page 16, I will now return the call to Emmanuel for his concluding comments.
Emmanuel Dulac -- President and Chief Executive Officer
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 studies.
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 two of them so far. We advanced our clinical program into Phase 1 and supplemented our early pipeline with the Company's first acquisition.
Our existing collaborations with Boehringer Ingelheim and Beta Bionics made strong progress. To validate our expertise in peptide and developing innovative therapeutics, we formed a new exciting partnership with industry-leader Alexion, and most recently secured significant funding from existing shareholder, 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.
Lani Morvan -- Investor Relations and Communication
Thank you, Emmanuel. This concludes our prepared remarks and thank you for your attention thus far. Carl, we are now ready to take questions, if you would please open the lines.
Questions and Answers:
Operator
Okay. Ladies and gentlemen, we will now begin the question-and-answer session. [Operator Instructions] And our first question comes from the line of David Lebowitz. Your line is now open.
David Lebowitz -- Morgan Stanley -- Analyst
Thank you very much for taking my question. Would you be able to compare the actual patient experience of administering the HypoPal pen versus the experience of administering other rescue pens and that are on the market?
Emmanuel Dulac -- President and Chief Executive Officer
Yes, thank you. Adam will take this question. Thank you, David.
Adam Steensberg -- Executive Vice President, Chief Medical and Development Officer
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 currently 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.
Emmanuel Dulac -- President and Chief Executive Officer
Yes. however, I mean now Phase 3 are available for all these products and so I think you can look at, indirectly compare these studies and results, but they -- just to caution, they use actually somewhat different endpoints. But there are some interesting findings that shows the 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.
David Lebowitz -- Morgan Stanley -- Analyst
Thank you for that. And is the pen, that's used with, as a glucagon similar to the pen that will ultimately be used for glepaglutide?
Adam Steensberg -- Executive Vice President, Chief Medical and Development Officer
They are similar, but they are not same.
David Lebowitz -- Morgan Stanley -- Analyst
I guess, how will that be different...
Adam Steensberg -- Executive Vice President, Chief Medical and Development Officer
The concept is similar, so both of those are of course, subcutaneous injections, but the rescue pen has been designed to serve a rescue emergency need and the pen used for that for glepaglutide is designed for chronic use. So I mean, that's why it's called a repeat for chronic use and not an acute setting. So similar concepts, auto-injectors, both of them subcutaneous, but they're not the same.
David Lebowitz -- Morgan Stanley -- Analyst
Thank you for taking my questions.
Emmanuel Dulac -- President and Chief Executive Officer
Thank you, David.
Operator
Okay. Our next question comes from the line of Etzer Darout. Your line is now open.
Etzer Darout -- Guggenheim -- Analyst
Great, thanks for taking the question. Just a couple from me. As far as the delays in the US and the UK 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, ZP7570, I guess given the timeline 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.
Adam Steensberg -- Executive Vice President, Chief Medical and Development Officer
Okay. Maybe on your first question, I think I can happily say that we have resolved the issues with the UK and US sites, and there were a little bit of a different issues. In US, I mean it's known that it takes time to open sites in US due to contract negotiations, and so on so forth. In addition to that we have made some changes in the people working on the trial, and then in that we have very, very positive feedback with from the CRO side.
In UK, it was actually extrinsic factor, due to some quality issues with the parenteral support that the patients were giving at the site that we, -- so a next-gen provider that, 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 few months in the study and the site activation.
The last question, could you just repeat that? The last part of your question?
Etzer Darout -- Guggenheim -- Analyst
Yes, I guess given sort of the expectations on the glepaglutide results now in 2021, could we also see ZP7570 Phase 1b results in that same sort of timeframe? The...
Adam Steensberg -- Executive Vice President, Chief Medical and Development Officer
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 that would be...
Etzer Darout -- Guggenheim -- Analyst
Great. Thank you.
Adam Steensberg -- Executive Vice President, Chief Medical and Development Officer
It will be coming around in the next year.
Etzer Darout -- Guggenheim -- Analyst
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 for competitive agent, the Baqsimi product has had sort of on that market or do you think that something that would take a little bit more time to kind of start seeing?
Emmanuel Dulac -- President and Chief Executive Officer
No, there are some actually publicly available data that have shown a very, 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 smaller, actually energy and dynamic in the market. So over the last 10 weeks globally, the market has expanded by 20%, and 17% of this 20% are 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 three to five years. And I think it's taking the right direction right now.
Etzer Darout -- Guggenheim -- Analyst
Great. Thank you for...
Emmanuel Dulac -- President and Chief Executive Officer
Again there is no -- there hasn't been any product differentiation in the past, so I think Baqsimi, is actually a, 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 their -- these events, these hypoglycemic events. And so I think this is a very important dimension for us to focus on.
Etzer Darout -- Guggenheim -- Analyst
Great. Thank you and congrats on all the progress.
Emmanuel Dulac -- President and Chief Executive Officer
Thank you. Thank you very much for your questions.
Operator
Okay. Our next question comes from the line of Alan Carr. Your line is now open.
Joseph Robert Stringer -- Needham -- Analyst
Hi, this is Joey on for Alan. Thanks a lot for taking our questions. 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 sort of resolve 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.
Adam Steensberg -- Executive Vice President, Chief Medical and Development Officer
All right. Okay, thanks for the question. I can provide a little bit more color on this. If I just talk about the screened patients, then in the start of the year, in the first half, we did see a little bit higher screened patients than anticipated, but again this is a nice thing that we can learn and then educate the sites and investigate it. So we see a reduction in that. So that is -- has clearly got in the positive direction.
On the external factors, there was an issue that was specifically related to UK sites and they provide a parenteral support, which has been solved. So that is not an issue. On the -- you can say the US sites, that's where we had to make some changes also in the personnel at CRO, and we have very positive feedback from the US investigators on the team that they are now collaborating with from our CRO. So that is also something we consider.
If I should then, on the number of patients we have in the trial right now, my belief is, we are around just below 40 patients as we speak, who have been randomized and we guide for 50. And you can say the predictions now for when we will have the patients enrolled, as I also mentioned in the call, we have 32 sites activated, and within the next month or two, 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 we, with the new guidance, we would have to have, let's say 10 to 15 patients entering the study per month, which is very in line with what we are starting to see right now. So that's why we have the confidence in what we communicate.
Joseph Robert Stringer -- Needham -- Analyst
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 prep and, 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? Thank you.
Emmanuel Dulac -- President and Chief Executive Officer
Yeah. Joey, that's a an interesting question, but that's a very competitive tentative [Phonetic] 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 finally, -- 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 and operational, it's probably 80% correct. And then as we go we actually still refine it and we actually modified 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 line of all the leaders of all the different functions and they are either on board or we are about to actually on board them.
Joseph Robert Stringer -- Needham -- Analyst
All right, thanks a lot for taking our questions.
Operator
Okay. Your next question comes from the line of Lucy Codrington. Your line is now open.
Lucy Codrington -- Jefferies LLC -- Analyst
Hi, there. Thank you for taking my questions. Just a couple for me. The first question relates to the artificial pancreas, given that we've already -- you've already had some meetings with the FDA, just wonder why the Phase 3 is not going to start till the -- till the end of next year? And then if you could give us any idea on timings, though 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 the treatment's success there and the competitors of you, the mean time, I just wonder if there's a reason for that? Thank you.
Adam Steensberg -- Executive Vice President, Chief Medical and Development Officer
Okay. Maybe I can take it, I can and answer these three questions. If I start with the last one, so the way we defined our primary endpoint of protocol that was the median time and we also used to observed mean, which mean, it's -- a median is actually the time where we do the sampling. So it's a first time where we have a 20-milligram, potentially the increase in plasma glucose. We could have used the mean time and observed, and the two means, then we would 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 designed the studies and the way we think is scientifically most thorough and clinically 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 of Phase 1, but there will be milestones once that program is getting into Phase 2 and we have outstanding milestones of DKK283 million. And as we also guide mid-to-single to low double-digit royalties on global sales. So, but there will not be a milestone with indication of Phase 1 with that amylin.
On the dual-hormone artificial pancreas, you're right, we reported the Phase 2 data in Q2 and we are in a very positive dialog with FDA together with Beta Bionics discussing the Phase 3 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 facts, one is it takes time to finalize the protocol, get it submitted and finally approved and then also get contracts and to start out running that. 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 3. We believe we have a product that can go into Phase 3, then the device also has to be ready to go into Phase 3. So it's getting all of 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.
Emmanuel Dulac -- President and Chief Executive Officer
But, rest assured that we are actually challenging these timelines, all the time and what we are providing here is actually a fairly aggressive timeline 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 we can.
Lucy Codrington -- Jefferies LLC -- Analyst
Okay. Thank you so much.
Operator
Okay. [Operator Instructions] Okay. Our next question comes from the line of Peter Sehested. Your line is now open.
Peter Sehested -- Handelsbanken -- Analyst
Yeah, it's Peter from Handelsbanken and thank you for taking my question. Related to the often asked question of the 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, now for traditional rescue, HypoPal rescue indication in Type 1 diabetes. So, just a recap or an add-on to what you've said before to pricing, please?
Adam Steensberg -- Executive Vice President, Chief Medical and Development Officer
So maybe Peter, I can just say one thing, before Emmanuel talks, but I am -- and one thing is the -- I think it's extremely important to notice that, its four different product presentations we're discussing here. One is the rescue pen intended for a 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 hyperinsulism, it's 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 that you would use considering the open 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?
Emmanuel Dulac -- President and Chief Executive Officer
Yeah, on top of that I would add that, these are different markets as well. So in the rescue markets, for example, the price is set, I mean there is already like existing products and so I think you have to align with the markets already accepting. In the other, I mean, indication, these are totally blue oceans. So the next three indications, we would be first-in-class. And so we are then looking at the formulations, the dosing the difference in presentation of the products and at the same time, on top of that, I would say, we add, what we believe is actually that the Company's philosophy that we would 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 these pricing. I mean today, I mean there is a lot of sensitivity around that and we are -- we will make sure that we will provide a very good value for the products we price.
Peter Sehested -- Handelsbanken -- Analyst
Just a follow-up question to the dual agonist product. Should we expect to see any type of Phase 1 data or should we just hold on until we see the Phase 2, and furthermore, will this Phase 2 study be a potential stepping stone for Phase 3 or should we see a Phase 2b study being being started with A1c and weight out of this primary end [Phonetic] points before you move into Phase 3? Thank you.
Emmanuel Dulac -- President and Chief Executive Officer
I mean, it will be up to Boehringer to of course decide when to publish data. So we cannot comment on, if you will see -- or be able to share Phase 1 data before we have the Phase 2 data. I think if you look at the Phase 2 study that they are, starting here it's 410 patients, it's actually six different doses of the product that are being tested and it's a 16-week study, which should provide enough data to move into Phase 3, but again it will ultimately be up to Boehringer to make these decisions.
We -- when we look at this potential 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 3, after the outcome if it turns out positively.
Peter Sehested -- Handelsbanken -- Analyst
Thank you.
Emmanuel Dulac -- President and Chief Executive Officer
Thank you, Peter.
Operator
[Operator Instructions] Okay, sir. There are no further question at this time. Please continue.
Lani Morvan -- Investor Relations and Communication
Very good. So, 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. Thank you.
Emmanuel Dulac -- President and Chief Executive Officer
Thank you. Thank you everyone.
Operator
[Operator Closing Remarks]
Duration: 40 minutes
Call participants:
Lani Morvan -- Investor Relations and Communication
Emmanuel Dulac -- President and Chief Executive Officer
Matt Dallas -- Senior Vice President and Chief Financial Officer
Adam Steensberg -- Executive Vice President, Chief Medical and Development Officer
David Lebowitz -- Morgan Stanley -- Analyst
Etzer Darout -- Guggenheim -- Analyst
Joseph Robert Stringer -- Needham -- Analyst
Lucy Codrington -- Jefferies LLC -- Analyst
Peter Sehested -- Handelsbanken -- Analyst
