Zealand Pharma A/S (ZEAL) 2017 Q3 法說會逐字稿

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  • Britt Meelby Jensen - President and CEO

  • Thank you, operator, and good morning, good afternoon, everyone, and welcome to this conference call where we will share the financial results for Zealand Pharma for the first nine months of 2017 as well as the business highlights.

  • So if we turn to page 2, we have the forward-looking statement. And then moving to page 3, we have the agenda for today, where I will kick off the business highlights from this quarter. And then also hand over to my colleague Adam Steensberg, EVP and Chief Medical Officer, to give an update on our pipeline programs. Then we will hand over to Mats Blom, our CFO, to go through the financials and then I will finish with an overview of the remaining part of 2017 and the outlook ahead.

  • So if we move to page 4 to highlight one of the events that happened in the third quarter, which was a listing on NASDAQ Global Select Market in the US, where we in August did a dual listing. So we are both listed on NASDAQ in the US in addition to our listing on NASDAQ in Copenhagen.

  • We issued a little over 5 million shares trading as ADSs on the NASDAQ Global Select Market in New York. So that means that now we have around 16% of our total shares trading on NASDAQ in the US and the remaining 84% trading on NASDAQ in Copenhagen. The total gross proceeds was DKK567 million or USD90 million.

  • So briefly on this, there were two reasons why we did that. One was to raise money to have sufficient to move full speed ahead on our clinical pipeline. The other one was to get more attractive and more visible to US investors, both in form of increased analyst coverage in the US, which we didn't have before, and also to accommodate the need of many US biotech investors who have restrictions on how much they can trade outside the US-listed companies.

  • So if we move to page 5, some highlights from the third quarter on our programs and the period hereafter. Starting with glepaglutide, and I'll hand over later to Adam Steensberg to go more in detail. But basically we had the two very exciting and important events on glepaglutide in this period. One being that we got the orphan designation in the US for glepaglutide granted by the FDA. Adam will talk more about that.

  • And then the other one was that we initiated and we have enrolled most of the patients in a study where we are looking for the optimal dosing prior to initiating the Phase 3 study for glepaglutide. Because we saw strong results in the Phase 2 trial indicating that it could be less than -- less frequent than once daily, which is the -- you consider standard of care what the current treatments are offering and what we saw on Phase 2. So Adam can talk more to what we are doing here, but that we are very excited about.

  • Then on dasiglucagon, and we will also come back to that, we started the first Phase 3 trial with our rescue product for severe hypoglycemia insulin shock. We also finished the patient enrollment in this program and we are on track to start the next pivotal Phase 3 later this year.

  • And then we got for dasiglucagon also an orphan designation in the US. As some of you may remember, we had the European orphan designation in the second quarter, but now we also got it in the US for congenital hyperinsulinism.

  • Then we have a collaboration with Boehringer Ingelheim that we'll come back to as well. Actually, it's two different collaborations with two different product candidates for diabetes or obesity. In particular, they have shown very strong weight loss data pre-clinical, and Boehringer Ingelheim has advanced both of these programs into Phase 1 development in the quarter. So overall, these are the highlights on our clinical pipeline.

  • If we move to the next page, page 6, an update on our collaboration with Sanofi, where they continue to promote Soliqua in the US remaining a strategic priority for Sanofi. And what you see on the graph on page 6 is that the weekly prescriptions are continuing to increase week over week without any declining trend.

  • And if we compare to the other product in this class, Xultophy, looking at weeks after launch, where I will remind you that Soliqua was launched in January and Xultophy launched mid-April. So the last points that you see on both of the lines is the same time. There's a significant gap between the two.

  • We see Sanofi putting a lot of resources behind these products and they continue to do that and have not decreased that since the launch. Soliqua was the first product in the fixed combination of a GLP-1 and insulin to be launched.

  • We see increasing formulary coverage quarter after quarter and expect that to continue this quarter with an increase of 4 percentage points over the last quarter to 65%. When we move into 2018, we will also have coverage of 21% in Medicare. And overall, you can see it's going in the right direction.

  • The only comment I will make is that if we look at expectations, you can see the comment that Sanofi has made based on their experience with the launch is that they have found that more education is needed of the physicians to break the habit of prescribing Lantus as the preferred insulin, to prescribe this new and better product. But they continue to address this in the marketplace. So we are quite confident in that.

  • If we look at the next page, page 7, we have an overview of the royalty revenue that we get from our Sanofi partnership. And we can see that from 2017 Q1 onwards since Soliqua was launched, it is continuing to grow at 37% in the recent quarter.

  • And we expect that growth to continue, driven by the weekly increase in prescriptions that we continue to see, the increase in formulary coverage that I talked about. And then very important as well, the European rollout. We expect next year to see a high number of also the bigger European countries launch Soliqua.

  • And if we -- what some of you may remember is that the label that Soliqua was approved for in Europe compared to the US is much broader in that it does not only cover patients already on basal insulin or GLP-1, but also patients that are currently treated with oral is in the label in Europe. So we look forward to see this rollout next year.

  • I would then like us to go a little more into detail with some of our progress on our own pipeline. And for that, I will ask that we move to slide 8 and I'll hand over to Adam Steensberg.

  • Adam Steensberg - EVP, Chief Medical and Development Officer

  • Thank you. And I'm really happy to share the recent updates. And I believe that we have made very significant progress in our clinical pipeline throughout the year here in 2017.

  • If we start out with glepaglutide, this is our long-acting GLP-2 analog where we have an ambition to develop that as a best-in-class treatment for patients with short bowel syndrome. And these patients, they suffer from an inability to absorb sufficient nutritions, fluids, and electrolytes. And we believe GLP-2, our GPL-2 analog, will have the ability to be a very good treatment option for these patients.

  • I am particularly happy to announce that we received an orphan drug designation from FDA here in October. This is an important milestone for Zealand, and we expect to have the European decision on orphan drug designation in Europe in the first quarter of 2018.

  • I would like to highlight three things associated with this milestone. First of all, this provides us seven years' market exclusivity in US. We will have financial benefits from the designation once the product is approved. And very importantly, it also allows us to have more support and interactions with FDA throughout the development program.

  • If you go to the next slide, slide 9, we believe that the main reason that FDA decided to grant us the orphan drug designation is actually based on the very strong Phase 2 data that we reported in June in patients with short bowel syndrome. Here, we observed an up to 30% decrease in fecal wet weight outcome after only three weeks of treatment with glepaglutide. Also, we saw very significant outcomes on several other endpoints, including energy absorption, urine production, etc.

  • Perhaps, and very interesting, we also observed the potential for less frequent dosing as the half-life was actually longer than we have observed before. We will present the data at a coming conference, ASPEN in Las Vegas, in January 23, 2018.

  • So if you go to the next slide, slide 10. Based on the encouraging data on half-life, we decided to initiate a PK trial earlier this year. So this is a 75-subject study where we test the full PK profile following daily dosing two different doses, but also following weekly dosing also at two different doses. And then we have an intravenous arm to be able to describe fully the PK profile of the drug.

  • And I can confirm that we are seeing very good progress in recruitment into this study and that we will have the top-line results in the first quarter of next year. And this is of course extremely important for Zealand because with that, I can also confirm that we are on track with getting the Phase 3 trial initiated mid-2018. And really what we will decide here in the first quarter is the potential for less frequent dosing, with the upside being weekly dosing in the Phase 3 program.

  • Then I would like to return to dasiglucagon on page 11. And dasiglucagon, that is a stable analog of human glucagon. So we have developed a molecule that can be kept in solution for years and thus we have an opportunity to replace existing use of glucagon and also expand the use into new opportunities.

  • And the three opportunities that we are currently pursuing is the rescue pen for treatment of severe hypoglycemia -- I will come back to that. We have initiated Phase 3 and we are well into initiating the next Phase 3 trial.

  • We are also pursuing the use of dasiglucagon in a dual hormone artificial pancreas pump which has the potential to transform management of Type 1 diabetes in that it can provide a game-changing modality whereby you fully automate management of this disease that is otherwise extremely cumbersome for patients to manage on a daily basis.

  • The last opportunity that we are going to discuss today and that we are actively pursuing is the orphan drug -- is the orphan indication congenital hyperinsulinism, where we, by using dasiglucagon as a continuous low-dose infusion into these patients who produces too much insulin, believe that we can provide a new treatment opportunity whereby we will either postpone or prevent the need for pancreatectomy in these neonates.

  • If we go to slide 12, this is an update on the clinical programs for our rescue pen. So in August -- sorry, in July, following very good interactions with FDA at an end of Phase 2 meeting in June, we decided to initiate the first Phase 3 trial for the rescue pen program.

  • This is an immunogenicity study which enrolls 90 patients. 45 patients received 3 doses of dasiglucagon and 45 patients received 3 doses of glucagon. And here, we will evaluate the immunogenicity risk of each program and of each products.

  • The results of this study is expected now in Q2 ahead of our own internal plans, as recruitment has actually gone faster than we anticipated. And I am also very happy today to be able to announce that we have actually completed enrollment into this study.

  • If we take the next slide, that is slide 13, this is a graph of the pivotal Phase 3 trial that we will initiate in early December. We have agreed on this design following interactions with FDA in the end of Phase 2 meeting. And most recently, we have also had the opportunity to discuss the full Phase 3 program with the UK authorities at a meeting with MHRA.

  • So the primary endpoint of this study will be time to a 20-milligram-per-deciliter increase in plasma glucose versus placebo. So you take patients and induce a hypoglycemic event in them and then we give an injection of dasiglucagon or placebo and measure the time to recover from this hypoglycemic event.

  • We have also included GlucaGen, so one of the old glucagon compounds as comparator to [honanna], the European needs for active comparator. So this study we also expect to read out in 2018 and thus we can also today confirm that we are on track with our planned NDA filing in 2019 for the rescue pen program.

  • If we go to slide 14, this slide presents our progress that we are making in the dual hormone artificial pancreas opportunity. And here, we are making significant progress towards initiating a Phase 2b in the iLet together with our partner Beta Bionics.

  • So as we have released following the first half of 2017, we concluded two Phase 2a studies in this -- for this opportunity, demonstrating, first of all, that microdoses of dasiglucagon are effective in increasing plasma glucose. This is important because that's how the pumps will use in the future.

  • And secondly, we were also able to demonstrate that the iLet algorithm works very well with the dasiglucagon drug. And thus we can bridge all the early data that has been generated in this system using the old glucagon products, which are not usable for commercial presentations.

  • What we have achieved during the last quarter is that we have produced the 1-milliliter prefilled 4-milligram-per-milliliter dasiglucagon cartridge with preservatives. So this is the cartridge that will go into the iLet in one chamber and then you will have insulin in the other chamber. So that product is now ready.

  • And also, I can confirm that we have concluded the chronic tox programs. Thus we are fully ready to move into long-term Phase 2b trials, which we plan to start in the iLet in 2018.

  • If we go to the next slide, slide 15, this is an update on our efforts to develop dasiglucagon as a low-dose infusion for treatment of congenital hyperinsulinism. So neonates born with a defect in their basal cells so they produce too much insulin, they have a high, high risk of having persistent hypoglycemia. And there are no satisfactory treatments today for these patients. Many of these end up with a total pancreatectomy, so they have their pancreas removed and thus they will have to live with full-blown diabetes for the rest of their life.

  • We believe that by infusing dasiglucagon at a low dose, we can counteract the effect of the excessive insulin and thus either postpone or prevent the pancreatic surgery since these kids will grow out of their disease at the age of 6 to 10.

  • So what we have been awarded by both the European and the US authorities is an orphan designation for the treatment of these kids with dasiglucagon. And we have had a good dialogue with both European and US authorities in their requirements for Phase 2 and 3 trials. And we are now in the final design phase together with key experts, key centers in the US and the UK, Germany, France to get these studies started. And we do expect to start them in the first half of 2018.

  • So that concludes my presentations on the dasiglucagon. And I would like to change to the next slide, slide 16, which provides a little bit of an update on the collaboration we have with Boehringer Ingelheim. First, as Britt said, we have two collaborations with them: one with a long-acting amylin analog and one with a GLP-1 glucagon dual agonist.

  • And both of these products were taken into Phase 1 development in August and both programs we expect we will have readout from these Phase 1 studies in 2018. If we start with the long-acting amylin analog, we presented data demonstrating the potential of using long-acting amylin analogs to treatment of obesity earlier this year.

  • And if you look at the graph, this is an impressive 15% decrease in weight when you treat with the once-weekly or every-five-day dosing with a long-acting amylin analog as compared to either a lower dose of this product or a GLP-1 analog alone. So we believe these are unprecedented preclinical data when it comes to efficacy on weight loss.

  • If you go to the next slide, slide 17, just to confirm that we have similar data when it comes to a GLP-1 glucagon analog. And also, the GLP-1 glucagon analog is a once-weekly product. And we believe thus both programs have a very competitive profile when you look into the obesity pipeline across the industry. I can also remind the audience that our next milestones for these programs are associated with the initiation of Phase 2 development and we are in a close dialogue with Boehringer on when that will happen.

  • Then to my last slide, slide 18, I would also highlight significant progress we have made in the research pipeline in the sense that we have initiated two new research collaborations here in this third quarter. One with Orbit Discovery and one with Torrey Pines Institute for Molecular Studies.

  • And both of these collaborations allow us now to tap into peptide libraries and thus expand our ability to come up with new and better peptide treatment opportunities for patients within the orphan TI and metabolic space. So we are very happy about these collaborations. And we also believe that they are a strong signal for how the external view -- how the external world views Zealand's capabilities in drug discovery and development.

  • And with that, I would like to hand over to Mats Blom, our CFO.

  • Mats Blom - EVP and CFO

  • Yes, good morning and afternoon to everyone. If we move to slide 20, I will shortly touch on the financials as of now. And of course, in Q3, the absolutely most important event financially was the US listing and the raise of capital we did there, where we raised gross DKK567 million, net approximately DKK500 million. And the effect of that on our financials is clearly seen in our balance sheet right now, with a cash position end of September of DKK780 million corresponding to USD124 million.

  • If we look at our operations, of course we've had revenue the first nine months, both from milestones. Approximately -- it turned out to be DKK101 million. We had guided for DKK100 million and the difference is just exchange rates. And we received all those money. And we have received royalty of DKK27 million so far.

  • Our costs are actually slightly lower than anticipated. But I think if we just move on to the next slide, we can see a little bit how that compares to previous period or the similar period last year on slide 21. Our revenue is higher and that is actually due to two things: both that we have more milestones this year than previous year and also higher royalty levels.

  • Our costs have increased, driven by the progress in our clinical development. But we have also been very much focused on cost control here. And as Britt will come back to later, we are actually reducing our cost forecast for this year as a consequence of this.

  • I will not touch more on the financials right now and I will take questions later by the end of the call. So I would just hand over to Britt to make the final remarks, I guess.

  • Britt Meelby Jensen - President and CEO

  • Thank you, Mats. And if we turn to page 23 with the overview of our clinical product portfolio. Outside this, we have a number of preclinical candidates that we don't talk a lot about in public.

  • But what you can see here is actually that we have delivered on all the products that we -- and the milestones on our programs that we set out to do beginning of this year. We are in preparation for Phase 3 with our glepaglutide. As Adam mentioned, we are in Phase 3 with our dasiglucagon rescue pen. We are moving towards the Phase 2b with our dual hormone pump.

  • And then we put for the rare disease congenital hyperinsulinism earlier this year on the map and we will start Phase 2, dosing the first patients in the first half of next year. We are in full preparation for that initiation and the dialogue with the authorities, as Adam mentioned. And then Phase 1 is ongoing for the two obesity programs with Boehringer Ingelheim.

  • If we move to page 22 -- no, 24, sorry -- to comment on the financial guidance for this year. As you may remember, we can only guide on financial -- on revenue coming from milestones, not from royalties, because our partner does not guide. So as Mats mentioned, I mean, we have achieved and maintained the guidance on the revenue.

  • And then we have lowered the guidance on the cost of around 5%. This is driven by a combination of timing of clinical activity and also tight cost control understood as we have optimized on the processes to bring our products forward and thereby having lower costs than we had anticipated.

  • If we move to page 25, an overview of our expected news flow for the remainder of this year and for next year. For this year, as Adam mentioned, we are in the final preparations to dose the first patient in the pivotal Phase 3 trial with our rescue pen, which should happen in some weeks.

  • Then we will have a rich year next year. Other than what you see below the line of the revenue reporting and the reporting of financial results, we have glepaglutide, the detailed results being presented in January. We have the top-line results on this PK study on the dosing.

  • We have results on the Phase 3 immunogenicity trial, and we will start also first half the Phase 2 in congenital hyperinsulinism. And then we will also later in the year when everything is ready start the Phase 2b for the dual hormone pump.

  • We will start Phase 3 with glepaglutide mid this year. We are very much on track on that, and then have results also from -- in the second half of 2018 from the pivotal Phase 3 trial on the rescue pen. Then we also will have next year from the two Phase 1 trials under the Boehringer Ingelheim collaborations have those top-line results.

  • So with that, moving to an overview of the -- on page 26, the upcoming events conferences where we will present for the remainder of this year as well as our 2018 financial calendar. I will close with that, only with one highlight being that we will host a capital market event in New York on January 25 where we will send out more details. But please mark that day.

  • And with that, I will hand back to the operator for the Q&A session.

  • Operator

  • (Operator Instructions) Thomas Bowers, Danske Bank.

  • Thomas Bowers - Analyst

  • Yes, thank you very much. Just on glepaglutide and the orphan drug status in US, I am just wondering is this somehow related to the possible once-daily profile? So I mean, if you need to cover Gattex with a twice-daily profile after all, I'm just wondering if that status is still viable?

  • And then also secondly, Shire has confirmed to me that they are working on also a better profile of Gattex as well. I am just wondering if you think this could pose a risk in the US if Shire is able to get a three-year exclusivity extension for this. If they manage to get a better profile, for example, with a once daily?

  • And then my second question, just to clarify on dasiglucagon and the CHI indication, is there any particular reason for you to start a Phase 2 rather than go straight into a pivotal Phase 2/3 trial, given that this is a rare pediatric orphan disease? And I guess also based on FDA feedback, I guess they also sometimes try to effect that you could jump directly into that once you have the safety data.

  • But is there something that you still need to work on in regards to the dosing in the pediatric setting? Or what is the reason for you not to maybe jump directly into a pivotal study? Thank you.

  • Britt Meelby Jensen - President and CEO

  • Thank you, Thomas. I think these were very good questions. And I will hand over to you, Adam, to comment on this.

  • Adam Steensberg - EVP, Chief Medical and Development Officer

  • Okay. Thank you, Thomas. So first on the orphan drug designation, that designation is very much based on the efficacy outcome of our Phase 2 study, showing where we are able to communicate the very strong effect in a patient group where we also still believe there is an unmet medical need.

  • When it comes into dosing frequency, this is less important when it comes to the orphan drug designation in US. In Europe, it could be a little bit more important due to different legislations and we can discuss that perhaps at a later time point.

  • With regard to Shire's efforts to develop a product that is easier to use or whatever and to get additional exclusivity, I think we cannot comment on their internal development efforts. And I think you probably have more insight than us.

  • But it will not affect our orphan drug designation since we are a new chemical entity. So we are a different molecule. Had we been a similar molecule, it could have caused -- the exclusivity could have prevented us, but this is not the case for glepaglutide. So that's how that is.

  • To your second question, that is also a very good question, and I can confirm here that this is also how we see the things. We are pushing very much towards starting this as a Phase 2/3 program. And since this is an ultra rare indication, we expect only a very, very few patients to go into the full program.

  • And we have just not had the final confirmations with the FDA yet whether we -- how we are going to do the exact trial designs. But our, you can say, we believe that it will become a Phase 2/3 study, the first that we start. But we need to have that final conversation with or confirmation with FDA before we firmly communicate it.

  • Britt Meelby Jensen - President and CEO

  • Yes, so this is for the congenital hyperinsulinism. And we did get some very encouraging feedback in the dialogue we had a couple of weeks back from FDA. So I think this is definitely where we are heading. But we would rather overdeliver than overpromise, so that's where we are. But I mean, I completely concur with Adam's statements.

  • Thomas Bowers - Analyst

  • Okay. And do you have any timelines for when you know from the FDA whether to pursue the 2/3?

  • Adam Steensberg - EVP, Chief Medical and Development Officer

  • So as we also communicated, we will start the next clinical studies in the first half of next year. And we would believe to have a very firm idea about the study, including phases, very early into 2018.

  • Thomas Bowers - Analyst

  • Okay. And EMA, how do they see things here?

  • Adam Steensberg - EVP, Chief Medical and Development Officer

  • I will let you know two weeks from now.

  • Thomas Bowers - Analyst

  • Okay. Great. Thank you very much.

  • Operator

  • (Operator Instructions) Alan Carr.

  • Alan Carr - Analyst

  • Thanks for taking my question. Wonder if you can comment a bit more about your plans for the Phase 3 trial based on the outcome of the different regimens that you are testing here in Phase 2 with glepaglutide, the weekly versus the daily.

  • How many -- what are you prepared to do in Phase 3? Are you open to running both daily and weekly arms in that? What sort of comfort level do you think you are going to have from this ongoing trial?

  • Adam Steensberg - EVP, Chief Medical and Development Officer

  • Thanks for that question. It's a very good question also. What I can say is we have not seen -- we have almost concluded recruitment into this study. We have not see the data yet, and of course, we need to see the data from the PK study in order to form our final view on how to take this forward into Phase 3.

  • And there are different scenarios. First of all, I will say, we have observed in the Phase 2 study that we have concluded a very, very stable profile. Meaning that you have a very stable exposure to the receptor. So we do not see a huge risk in changing the dosing regime if we can obtain a similar stable profile by going, let's say, twice weekly or once weekly compared to how it was dosed in the Phase 2 trial.

  • It would have been a very different story if we had had spikes as a highs and lows throughout the day, etc. So the risk of changing the dosing regime we believe is very limited. Once we see the data, then we will make a decision. I can say that the scenario that we work through right now is less frequent dosing. But again -- and that could be twice weekly or once weekly. But of course, we keep the once-daily option open as well.

  • Alan Carr - Analyst

  • And then with respect to dasiglucagon and the pen, the Phase 3 program for the emergency pen, what else is needed besides the two Phase 3 trials? Is there any supportive work that you are going to need in addition to that? Are you going to be testing the pen in that second Phase 3 trial or is that going to be a syringe that you are going to use in that? What are the other supportive work that you need here for registration for that pen?

  • Adam Steensberg - EVP, Chief Medical and Development Officer

  • Thank you for that question. So the immunogenicity study that we started in July and also the pivotal study that we will initiate here in December, those will use the syringe. And these are the last studies. These are the studies that includes 90 patients for the first study and 150 patients for the second study.

  • Then we do plan to do a much, much smaller, I would say, third Phase 3 trial, start that early next year. That could include the device or we will simply decide to do a small bridging study to include the device. That allows us to have that into the registration.

  • Then, of course, you have the human factor studies, which you always have to do with -- we have initiated those. Then you have your pediatric program, which we will also initiate early next year to study the effect in small children. We believe that those studies are important to have as part of the initial NDA since rescue pens are very often used in small kids.

  • And so that is something we will also start early on -- early next year. And that also takes me back to what we put in the presentation, that the NDA is planned for 2019 despite the fact that we conclude these two large Phase 3 trials around midyear 2018.

  • Alan Carr - Analyst

  • All right. Thanks very much. Appreciate you taking the questions.

  • Operator

  • Peter Welford, Jefferies.

  • Peter Welford - Analyst

  • Thanks for taking my questions. I have got two, I think. The first one actually is more of a follow-up to a question you've just answered, which is -- so sorry, am I to understand here that after you have done then the second Phase 3, you then need to initiate device, I guess human testing studies, etc.? And those -- or are those going to be running parallel? And I guess also -- sorry. You just outlined [dally]. Sorry, maybe I missed this, but exactly what the gating factor is there for the 2019 filing?

  • And then just secondly on the artificial pancreas form there, just curious. Are you comfortable now with the algorithms and the dosing that the iLet device is using? I know some work went on with those. So is it now a case therefore that the Phase 2b will be testing just, if you like, a dose response of the glucagon together with insulin? Or will there also be some investigations into the device and the algorithm in the device itself at the same time? Thank you.

  • Adam Steensberg - EVP, Chief Medical and Development Officer

  • Thanks for those two questions. With regard to your first question on the rescue pen Phase 3 program, I mean, the studies that I mentioned will run in parallel with the two studies that were presented today. And you can say with regard to the device study, it is just, you can say, the bridging study, that will be a bridging study that shows that the device and the syringe performs to the same level, which should not be difficult to demonstrate since it's the same syringe that is just sitting inside an autoinjector versus being injected by a trained healthcare professional.

  • So these are things that will run in parallel. And we expect to conclude these studies throughout 2018, perhaps into the first months or so of 2019. So these are things that run in parallel. And you know, I think I should also remind you that when we talk about NDAs, it's not just about clinical data. It's actually getting the full quality package in place. There are batches you need to produce at your CMOs, etc.

  • And this is where we also believe that we are fully on track to deliver on the NDA at a quality level which is very, very high. So this is why you see these timelines from us at this time.

  • If we take the second question with regard to the iLet, I must say that we are very, very comfortable with the algorithm that we tested. First of all, this is an algorithm that Beta Bionics has been working on for almost 20 years now, improving year over year.

  • And with the Phase 2a study that we concluded earlier this year, we were able to demonstrate under extremely challenging conditions where we challenged the patients in any way we could think of in order to push them into hypoglycemia that it works very well together with dasiglucagon. So we are very comfortable when we move into the Phase 2b study.

  • What Beta Bionics is doing right now is to do, I would say, the final adjustments to the device itself, another algorithm. And then we will go into a Phase 2b study, where we will test the performance of the iLet device when it runs in a dual hormone mode -- so that is where you have both insulin and dasiglucagon -- compared to how it performs when it runs in an insulin-only mode. More similar to the systems that other companies have also been working with.

  • And here, Beta Bionics has throughout the last year been conducting a lot of studies to demonstrate, you can say, the differences with regard to time and range, how automated you can make it, and how much time you spend in hypoglycemia.

  • So also based on those data, which are based on shorter studies, we are very confident that the Phase 2b study will show that the iLet in a dual hormone setting will outperform significantly the iLet running in an insulin-only mode and be -- I mean, our ambition would be here to demonstrate the best data ever seen for treatment in a semiautomated to automated fashion of Type 1 diabetes in a four- to six-week study.

  • Peter Welford - Analyst

  • That's great. Thank you.

  • Operator

  • (Operator Instructions) There are no further questions in the queue. I would now like to turn the call back over to the speakers for any additional or closing remarks.

  • Britt Meelby Jensen - President and CEO

  • Thank you. And I would like to thank everyone for joining this call and not least for also very good questions. And I wish you a good rest of day.