Zealand Pharma A/S (ZEAL) 2017 Q4 法說會逐字稿

Thank you, and good morning, good afternoon, everyone, and welcome to this full year 2017 results conference for Zealand Pharma. I'm here today with our CFO, Mats Blom; and our Chief Medical and Development Officer, Adams Steensberg.

So if we move to Page 2, we have the forward-looking statement where I refer to the SEC filing for risk factors. On the next page, Page 3, we have the agenda for today's meeting. I will start going through the business highlights. Then, I'll hand over to Mats to go through the financials and then come back to finish off with the 2018 outlook before opening up for questions.

So on the next page, Page 4, the highlights of our company. We're a world-leading company in peptide discovery and development based on our validated platform and -- which holds prospects for new pipeline expansion. With the strong progress and outlook for our clinical pipeline, which we will go through today, we have a very different story to tell than we had in the past in that we have a late-stage pipeline today with very interesting elements that you will see more.

So I would like to turn to Page 5 to look at the specific progress we've had on the pipeline. So we've had major advancement on our late-stage clinical programs. And if we start with glepaglutide, we unlocked the potential for this long-acting GLP-2 analog for short bowel syndrome in 2017. We did that with very strong Phase II results in the middle of last year, which led us to initiate a PK trial that supported the potential of once-weekly dosing underpinning the best-in-class potential of this product.

For dasiglucagon, we started the 2 Phase III trials in 2017 with the HypoPal rescue pen for severe hypoglycemia. We reported results from 2 Phase IIa trials for treatment in a dual-hormone pump together with insulin for type 1 diabetes. And also, we reported, early this year, that FDA granted safe-to-proceed -- the safe-to-proceed letter to move into Phase III for this rare indication and where we also got orphan drug designation, both in the U.S. and Europe.

On partnerships, we advanced 2 -- or our partner, Boehringer Ingelheim, advanced 2 programs into Phase I for obesity and/or type 2 diabetes, GLP-1 glucagon dual agonist and an amylin analog. We also expanded our research partnerships with 3 new partnership agreements with Orbit, Torrey Pines and UniQuest.

And then, for the overall business, a key event was late summer where we listed in the U.S. So we're now a dual-listing -- listed company, still with over 80% of our shares trading in -- on the Danish stock exchange, but we did raise gross $90 million.

On the organization, we announced an expansion of the leadership team with Ivan Møller heading up Technical Development and Operation, a function that has naturally been established due to the progress in our late-stage pipeline. And then, we have also engaged with a strategic adviser to management, Dr. Francois Nader, who is U.S.-based and has a documented track record in building a biotech company and building the commercial set up for rare disease in the past.

So moving to the next page, Page 6, we have an overview of our pipeline where, aside from the marketed products under our partnership with Sanofi, we have dasiglucagon HypoPal rescue pen. In Phase III. We have 2 Phase III-ready assets in the dasiglucagon congenital hyperinsulinism and glepaglutide. And then, we also have an attractive preclinical pipeline with GLP-1/GLP-2 dual agonist that is getting close to the clinic that we expect can be advanced into the clinic next year.

We also have, as you see here, elsiglutide on the pipeline chart. This is the one we got back from Helsinn last year where we are currently looking into interesting indications that we could explore with that GLP-2 analog, which is a slightly different GLP-2 than glepaglutide. So we'll report more when we have made a final decision on what indication and how to move that forward.

So moving to Page 7. Our overall strategy, as you see here, is to build a fully integrated biotech company. And that we will do by maintaining full control over the assets or product candidates in rare diseases. And then, in broader indication, such as diabetes care, we will engage in and grow the value through partnerships, both commercial and development partnerships. And if we take a look at the future portfolio, our plan is to continue with that strategy to go alone with rare diseases and engage in partnerships when we are looking at the broader indications.

So moving to Page 8 for more specific updates on the programs. If we start with glepaglutide, our long-acting GLP-2 for short bowel syndrome, we had major news in the Phase II results that we reported in June last year where we showed very strong results on the primary endpoint, a relative fecal wet weight output reduction of up to 30% following 3 weeks of dosing with glepaglutide.

We also had a number of other interesting data points where -- which were presented at a scientific conference, ASPEN, end of January in the U.S. So one of the other interesting data points that came out of this was actually that the drug may have a longer half-life than what we originally thought. And that led us to initiate a PK trial to explore. If we could give this less than once daily, which is what the current product on the market, Gas-X, which is a self-mixing product and not a liquid formulation ready-to-use product like ours, but that is given once daily.

If we move to Page 9, we can see the results -- the top line results of this PK trial that we initiated in the fall and concluded in January of this year. The graph on this slide is illustrative, showing that what we found in this study is that the exposure levels with both twice-weekly and once-weekly dosing of glepaglutide is around the same level obtained with the 1-milligram per day dosing that we had in the Phase II trial.

So if we look at the next page, Page 10, we believe that the glepaglutide has potential as a best-in-class product. If we take a look at the left-hand side here, some of the key unmet needs that you -- that we still see with short bowel syndrome patients, we actually believe that we can address these better than what has been seen to-date. First -- the first 2 ones, reduction and removal of the need for parenteral support, we had very strong indications from the Phase II data that we can show promising results on this.

The same goes for the increased absorption of both nutrition and fluids, which also we saw in the Phase II results and then the reduction in fecal wet weight output, which was the primary endpoint in the Phase II. And last but not least, also the reduction in treatment complexity by having a ready-to-use liquid formulation product being dosed once or twice weekly. We believe it's a significant advancement in treating these patients over what is today available.

So if we move to Page 11, looking at the next steps. We are very prepared to start Phase III later this year. We have engaged the overall PI and -- PIs both in U.S. and Europe. We have more than 10 centers in U.S., Canada and Europe committed -- I mean, 10 in U.S., Canada; and 10 in Europe, respectively, ready to be part of the Phase III program. We have had a number of face-to-face meetings with these [investigators] and experts to get input to the design of the Phase III program. And we're basically expecting regulatory approval in the second quarter of this year, and then we can start the Phase III trial mid-2018.

So if we switch to one of our other lead assets, dasiglucagon, and move to Page 12, that product we are actively pursuing in 3 different indications: 1 being a rare disease congenital hyperinsulinism, and 2 in diabetes care.

If we start with the rare indication on Page 13, we got the significant news from FDA in January with the safe-to-proceed letter that we could move into Phase III directly. So what we're basically preparing for now is 2 Phase III trials that we expect to initiate later than this year, 1 for neonates and 1 for smaller children. So in total, around 50 patients in the Phase III program is what we expect.

And basically, what we have developed here is a glucagon in a ready-to-use cartridge. And we are working with one of the leading insulin pump companies to use an insulin pump for infusion of our dasiglucagon into these children where we can, basically, through a pump infusion, reduce the need for surgery. These kits are producing too much insulin, so they are in a constant low blood sugar and by giving them glucagon, you avoid that they need to remove their pancreas and become type 1 diabetic, and you also, in the milder cases, prevent hypoglycemia.

So moving to our Phase III program on Page 14, the most advanced indication. We have developed a ready-to-use glucagon analog with a very fast onset of action compared to what we know from today that we are actively pursuing in Phase III development to treat severe hypoglycemia or insulin shock, which is a significantly better offering than the current available glucagon kits on the market with lyophilized powder that you need to reconstitute, which we have seen that most even caregivers are not able to do. This product is -- and what Zealand has really developed is the unique skills of making this peptide stable in a liquid formulation, something that is -- has previously turned out to be quite challenging.

If we move to the -- to Page 15, there's an overview of the 2 Phase III trials that we are currently doing. The first one is actually complete. We reported a couple of weeks ago the last patient visit. So we should have results in second quarter of this one. And then I'm happy to announce also that the patient enrollment is very much on track for the second and pivotal Phase III program, where we have 3 arms -- a dasiglucagon arm, a placebo arm and a GlucaGen arm -- with a total of 156 type 1 diabetes patients, which we can report results from later this year.

So on Page 16, the third indication that we're actively pursuing with our dasiglucagon is also with the glucagon in a cartridge used in a pump together with insulin. So we're working with Boston-based Beta Bionics, who are the leading company in developing a pump with 2 chambers, 1 for insulin and 1 for glucagon. And with a sensor from Dexcom and insulin and now this with glucagon, you can basically revolutionize how type 1 diabetes is treated by having -- not having to worry about mentioning blood sugar, what you eat when you exercise because the algorithm will calculate when you need insulin and when you need glucagon.

So on Page 17 is an example of the data that we're looking to replicate in a Phase IIb trial. This is from The Lancet published in 2016 on Page 17. In using the lyophilized powder from Eli Lilly, basically showing that if you treat with insulin and glucagon in a pump instead of insulin alone, you are able to create a much flatter blood glucose profile and treat much closer to target. And these are the data that we're looking to replicate in a longer study than this one, an outpatient study as a next step using the Beta Bionics pump.

If you look at Page 18, this is an overview of the data. I will not go through this from the 2 Phase IIa trials that we reported on -- in Q2 last year, which was really one showing that our glucagon is effective in very small doses. The second one showing that our glucagon works with the algorithm in the Beta Bionics dual-hormone pump. And these were the conclusions from these studies that basically also supported that we advance into Phase IIb, which we expect to initiate later this year in collaboration with Beta Bionics.

So to conclude on Page 19 on the progress on our portfolio before moving to the financials. Our clear focus is on rare diseases and moving both glepaglutide and dasiglucagon into Phase III this year. We believe we are well positioned to advance into the market in a couple of years with these 2 indications. And in diabetes care, where we see us being successful through partnerships, we also have had the good progress and are actually in active discussions with partners. And then we have strong progress on the future pipeline as well where the same principles apply in that we will advance programs in rare diseases ourselves and engage in partnerships when it comes to larger indications.

So with that, moving to Page 20, I'll hand over to Mats Blom to go through the financials.

Yes. Good morning and good afternoon, everybody. I will have a short overview of the financials for 2017, starting on Slide 21, which is basically a summary of our income statement.

I will comment on the individual elements in the slides to come but just to give an overview of the year, we had revenue of DKK 139.7 million, which is down 40% versus the year before. This is driven by milestone payments. For those of you who follow us, in 2016, we had a very high milestone payment tied to the approval of Soliqua in the U.S., among others.

If you look at our royalty revenue, it's up 60%, but the total is still down for the year. And our cost base has increased. And that is, of course, a result of the success in our clinical pipeline. As we develop into later stages, our clinical costs do increase.

If we move to the next slide, I will shortly comment on the royalty revenue, which is, of course, the important revenue for us going forward since it's coming quarter-on-quarter mix not event-driven. As I mentioned, it increased 59% in '17. As you can see in this graph, the increase is purely driven by the launch of Soliqua, which was launched in January, while the Lyxumia/Adlyxin revenue is slightly down and seems to flatten out.

So what can we expect in the future? As you know, we don't guide on this, but what we can see is how weekly prescriptions in the U.S. are increasing steadily. The graph to the right shows quarter-on-quarter in '17. We'll continue to track this. And saw that last week, we're on around 3,500 prescriptions. It seems to continue more or less in this pace. It should, hopefully, increase as market access with insurance companies in the U.S. increases.

If we move on to the next slide, we have summarized a few trends in the company. I had talked about the royalty income. You see our operating expenses -- our net operating expenses are increasing. As you can see for this -- from this graph, it's, of course, that our admin costs are kept stable. And the increase is driven by the -- our clinical -- late-stage clinical programs.

Looking at cash. Comparing this year versus 2016, we end this year with close to DKK 670 million in cash, slightly up versus last year. What is most important is, if we compare it to last year, almost half our cash position was restricted for us to use. And I will comment a little bit more on that if we move to the next slide.

I've tried, on Slide 24, to illustrate what's happened with our cash position during 2017. We started a year with DKK 642 million of cash, of which approximately half was restricted to be used. Then our operating activities have taken down our cash position. And in March of '17, we repaid half our royalty bond. By doing this, first of all, of course, our loan went down, but we also released all restricted cash. As Britt mentioned, we did a IPO in August, increasing our cash position, and then there are some other items. So I'm just trying to illustrate what's happened over the year here.

So looking forward, our guidance for next year on Page 25. We continue not to guide on royalty revenues if Sanofi doesn't guide. And we're so early in the launch, so it's very difficult for us to make any reliable forecast here.

What we do control is our cost level, and we guide for operating expenses this year in the range of DKK 475 million to DKK 495 million or $76 million to $80 million. And once again, it's driven by the, basically, Phase II and Phase III programs we have running this year.

With that, I will hand back to Britt to conclude the call and then move into questions, right.

Thank you, (inaudible). On Page 26, we have the agenda and then moving immediately onto Page 27 with the news flow for next year. What we can see is that we expect news from -- we already started the year with a detailed Phase II trial results on glepaglutide, and there's positive results on the PK trial. So the big event will be mid- this year where we start the Phase III trial.

On dasiglucagon, we'll have results early this year. So in Q2 from the first Phase III trial that we have already concluded and then in the last part of phase -- of 2018 on the second pivotal Phase III trial, and then we have our dual-hormone Phase IIb initiated as well as congenital hyperinsulinism.

Last but not least, we also expect results from the clinical progress with Boehringer Ingelheim for obesity -- the Phase I for obesity and/or diabetes as well as to make -- update you with progress on the next candidate there for Phase I -- of our own programs for Phase I initiation next year.

So on Page 28, to wrap up. We do see a number of value-driving catalysts in 2018 with where we will have 3 programs in Phase III development all ready to be on the market in the next 3 to 4 years. We also see potential for additional high-value partnerships that we cannot comment more on that what we have already done. And then, we continue to explore new products and new concepts with our validated peptide platform and technology.

So this is how we're moving forward, continuing with a lean and agile organization and an effective business model that allows us to make fast progress on our pipeline, as we have done in the past years towards the market.

So with that, moving to Page 29, I will hand back to the operator to lead the Q&A session.

(Operator Instructions) We will take an opening question from Tony Butler of Guggenheim.

Britt, 2 questions. One is, I seem to recall that there was some discussion about seeking partners outside of the U.S. and, potentially, Europe for glepa. And I wondered if that was progressing or your views there if you could. And then the second question, if I may go ahead and ask, is around Lilly's nasal glucagon, which as you know was a license from Locemia in '15. It is in Phase III trials though, ClinTrials only has it in Japanese patients, but I'm curious how you think about that as a potential, let's just say, competitor in the rescue -- well, in the rescue market because I'm guessing they want to transition from their rescue pen to a rescue inhaler?

Thank you, Tony. Two very good questions. If I start with your first question on the glepaglutide partnerships. Our main focus is, actually, on outside U.S. and Europe and rest of world, mainly focused on Japan, where, as you might know, there's -- they are -- that population is highly affected by TI diseases, so gastro diseases. So we are actually making very good progress in our discussions with the Japanese companies and Japanese-based companies. We've already had a number of meetings and are well into the process. I think this is a trial, if I can comment on that, and we think it makes a lot of sense to engage with a local partner partly because they have the local expertise and partly also to offload some of the costs from our side and through this partnership. So I think there's a lot of progress, and I will not comment on when we can close anything. The thing I would say is that we will -- I mean, we will do that when we have something that we think is an attractive agreement for Zealand. Then, on the nasal glucagon, I think very good question. And you can say we're obviously following that closely because Lilly is, with the lyophilized powder, market leaders in the U.S. today for the rescue treatment. We have done some market research on this where we have actually seen that patients do prefer an injective -- an injection -- an injective pen like the one we have over nasal. And when we try to understand closer -- and this is both market research that has been done in patients and caregivers -- it is very much related to the fact that -- I mean, that patients and relatives will be concerned whether the patient really gets the full dose when it's sprayed into the nose in a situation where it's a life-threatening situation and the patient is very often unconscious. So this is really where we see that caregivers and patients seem to be more comfortable with something that is injected. And then on top of that, we also have an assumption that our -- and some indications from our trials that we have an attractive onset of action that can be -- that can prove very stable. You can, of course, say this is an underappreciated condition, the severe hypoglycemia. And there has not been much marketing of the current product. So in a way, we are not -- I mean, it's both a negative with more competition but net-net also a positive because then there will be more awareness and a big company like Lilly also promoting a product for this indication, putting more emphasis on treating this and that patients should actually have a product to treat this indication, where we know today that less than 25% of those who should have one actually has one. So it's not bad for us to have another product. And I think, as I mentioned, we do think that it could potentially be a benefit to also have a product that is injectable where patients and caregivers are more comfortable to know that they actually get the full dose of the product when it's used. So I hope that addresses your questions.

We will take our next question from Thomas Bowers of Danske Bank.

So a couple of questions from me. I just want to follow up a bit on the whole partnering situation. I see in the report that it's sort of the first time that you mentioned this in connection with a potential 2018 value driver. So I understand, of course, the whole glepaglutide x U.S. stuff, but you also put in the rescue pen as part of the 2018 value driver. So I'm just curious, could we also potentially see a partner agreement for the rescue pen prior to the Phase III pivotal data readout because, I guess, that's very late '18? So should we just see this as primarily a '19 milestone as you will most likely want to see the data and then give a -- get an out-license agreement maybe prior to approval or very soon after approval? And then my second question on Soliqua, you mentioned the option to monetize the value of the royalties in connection with the Capital Markets Day, but I don't see anything in the full year report. So I just want to be clear, are you still considering to sell the royalty stream and is also -- is that a possible near-term event? Or you sort of still awaiting to maybe, say, maximize the value of it if you want to hold on to see the '18 numbers in U.S. and maybe also some impact from rest of world? And then, my final question just a quick one regards to the guidance. You do not include any milestone payments for the year, but I'm just wondering if we could see a milestone from current partnerships? And of course, I'm thinking of the 2 Phase I trials from Boehringer. So is there potential upside to the top line from potential milestones, so to say?

Yes. Thank you, Thomas, for 3 good questions. And I'll try to address. If we take the first one first on dasiglucagon partnerships, so what -- I mean, you can say why we are out talking about that now is, I mean, it's because we are in active discussions. And you can say -- I think we have known for a while that we could benefit from having a partner to commercialize this product by basically -- I mean, a company that already has an established commercial setup where this product could fit. We're not, necessarily, in a hurry to do a partnership, but because we have started to engage in discussions, we have decided to be public about it. And to your question about whether we would do it prior to Phase III, I think it does take time, I mean, from starting the discussions to having all the final details negotiated. And we basically don't have a strong preference for, I mean, the timing of that. And we also not in a need to do a partnership agreement in 2018. But it -- I mean, but it -- there are, of course, benefits of knowing those next steps, while on the contrary, there are also partners that, clearly, are keen to see the results. In general, I think the feedback that we have and how we see this is that the Phase III trials that we have ongoing are fairly low risk in the sense that we're essentially replicating the Phase II trial that we already reported on basically showing that we are able to get the patients back to the normal blood glucose levels at fast speed. So it's not something we see as a major concern around the results. But -- so I think this is what I can say on that and to say we will make an agreement when we find comfortable that we have a partner that will also prioritize the commercialization and that is a good fit. Then on your question on the royalty, I think you can say how we have -- how we see this is that this is -- and how we've also talked about this so far is that this is a nice option to have, but we don't have any plans to pursue that right now. You can say it's -- we're being approached all the time from companies that are keen to buy the royalty stream, but we also have strong confidence, I mean, based on the effort and the resources we see that Sanofi puts behind the launch and rollout of Soliqua. I mean, we're quite comfortable ourselves that they can deliver. So Soliqua will create value in a stable and growing revenue stream for Zealand for the next many years. So this is really how we see it. So we have more listed it as an option and not something that we are actively pursuing right now. So I hope that clarifies that one. And then on your question on milestone, so from Boehringer Ingelheim to start with, what we have previously also said is that, from start of Phase II, it's when the milestone revenue starts to get sizable for Zealand given that we expect to have results of Phase II later this year...

Phase I.

Phase I, sorry, later this year, we don't expect the Phase II initiation this year. And I will not comment on whether that's likely or not, but I would think beginning of '19 could be a more -- is the base case scenario that we are working with. So that's also why we did not want to put anything in -- on that one in our guidance. So I hope that makes sense and answers your questions.

Yes. That's great. Thank you very much. Maybe if I could just add in one additional question (inaudible) because I've got track of Gas-X quarter-on-quarter, and it seems like it's taking off quite nicely the last couple of quarters here, 50% to 60% year-over-year growth. I know, of course, Shire has been struggling somewhat with some production limitations, some issues there, but so that, of course, could be an explanation that they've sold this. But I'm just wondering if you see any changes in how physicians are starting to treat the patients. Are they starting to use GLP-2 more? Are they feeling more confident in using these types of medicines?

Yes. I can start and then Adam may want to elaborate. But you can say, as you said, last year what -- Shire reported revenue of $335 million last year. So that was over 50% increase versus '16, which was again a 55% increase versus '15. So it's growing nicely. And you can say in particular in the last quarter of '17, they had revenues over $100 million. So we do expect that trend of growth continuing. So you can say -- so that we, of course, are pleased about in terms of trading the market. What we do see, and I think what Shire also said was that, I mean, the growth is a nice mix of volume growth and also a value growth. I think what we hear is very much anecdotal, and we, unfortunately, because this is a rare disease, there's not a lot of data available. But overall, it seems like doctors are very pleased with the GLP-2 treatment and with Gas-X, and they actually do see an effect from the treatment. Also, we -- it seems like there's a fairly high dropout rate on some of this. It is one of the most cumbersome self-mixing medicines on the market. And we're not really sure whether that is one of the reasons for that. I don't know, Adam, if you have anything to add there on this?

I think, again, it would be based on discussions at conferences, et cetera. But one potential -- one key factor is that, that physicians start to better understand who are the patients who really benefit from GLP-2. Because it's a new treatment opportunity and there's such a heterogeneity among the patients, it has taken some time to understand who really benefit. And hopefully, also, as Britt alluded to, we would start to see less dropouts, whereas in the earlier days, there were patients they were getting on and then getting off again, perhaps because it was not the right patients who got into these treatments. So I think it's reflecting that physicians start to understand better who can benefit. I think something that will really benefit also the overall opportunity in the years to come is that we see more and more of these high-volume centers or big clinics in U.S. putting that bet on treating these patients. And again, centralizing treatment of these very difficult-to-treat patients is something that, hopefully, will also drive volume in the years to come for GLP-2 treatment.

We will take our next question from Alan Carr of Needham & Company.

A few of them around the trials that you have planned, what can you tell us about the Phase IIb design for the dual pump?

Okay. So this is Adam. It's -- of course, it's still being discussed with our partner Beta Bionics. And I think what we can share right now, we planned -- it's going to be an outpatient study. It's going to be a study where you actually use the real device, which contains chamber both for insulin and one for glucagon. And then, it's most likely going to be a 4 to 8 weeks study, which we're just nailing down, I would say, this month. And really the purpose of the study with a clinical endpoint, looking into time and range and all the important glycemic parameters. And really with -- the purpose of the study will be to provide the first ever, I would say, clinical evidence of true outpatient treatment with a dual-hormone system of fully automated treatment of type 1 diabetes patients. How effective is that when you use 2 hormones versus having the system to only run in an insulin-only mode? But given this is the key thing. It's the first proof-of-concept that -- what you can achieve by having 2 hormones versus only having insulin-only systems. And the second purpose, of course, is to then provide the data that will allow us then to move into Phase III studies later on. So the regulatory studies, which will, of course, be somewhat larger studies.

(Operator Instructions) We will take our next question from Levi Marion of Bryan Garnier.

Hugo Solvet on [behalf of] Eric Le Berrigaud, actually. I dialed in late. I'm sorry, if you already answered the question. You're talking about increased royalties from Sanofi in 2018, but what do you start to expect in terms of milestones in 2018 from any source? And second question, also, can we reasonably expect a partner for dasiglucagon rescue therapy to be announced somewhere in the second half, maybe Q3?

Yes. So thanks for those questions. So if I take the dasiglucagon question first, I will -- I cannot and should not comment on the timing of this. And I think simply because I don't want to be in a threat where, I mean, in negotiations where we put a fixed time line. And secondly, I think we're ready to make a partnership agreement on commercializing the rescue pen when we have the right partner where we see attractive financials and also where we're comfortable with the commitment from the partner. So this is really how we see, but it could very well happen as we are quite progressed in some discussions. On Soliqua and on milestones in general, as I commented before on Boehringer Ingelheim, we have sizable milestones from start of Phase II. And we don't expect these this year. Our base case assumption is early next year. And then, on Soliqua, we have up to $100 million in commercial milestones based on a cumulative. So year-on-year, sales and coming in 2 big portions plus a tail. So we actually believe these are achievable, but we don't see them being achievable this year. Hence, we have not guided on any milestone revenue for this year. Hope that addresses your questions.

We will take a follow-on question from Alan Carr of Needham & Company.

I'll come back to the -- there are a couple around the upcoming trials. One of them, what can you tell us about the design of the Phase IIb trial with the dual pump that you had planned? And then around the -- actually with the CHI trial, you mentioned that you wanted to do 2 Phase IIIs in different age patients. Are those both going to start around the same time? And what you're thinking around when we'll have results for that? And then the last one is around the short bowel trial. You have 3 arms in that one, and you mentioned that you had about 10 sites lined up both in U.S. and Europe. What's your level of confidence in terms of enrollment rate around those? I know KOL at your Analyst Day a few weeks ago, I was optimistic, but what's your latest thinking about enrolling patients for those?

Okay. Thanks for the questions. So if I start with your last question on our short bowel syndrome trial, where you're correct that we will actually include 3 arms; so 2 active arms and the placebo. So once weekly and twice weekly and then placebo. I think -- and then your questions were around recruitment. I think we've shared it -- this at several, you can say, conferences our several touch points, that we've actually invested significant efforts in building up and investigating our network over the last 2 years. So we feel really, really confident that we have the right centers now engaged with the Phase III trial. When we announced also here at ASPEN, in January, to the investigators that we're going for this once-weekly and twice-weekly dosing regime, that created a lot of excitement. And of course, key to success here is that the investigators are excited. So from their perspective, having this opportunity to dose less frequently with a very easy-to-use product is something that means a lot to them, and that goes beyond just efficacy. So that should help us in our recruitment in the studies. Again, it's something to monitor very closely. We're putting all our efforts in to make sure that we recruit and as fast as possible, while at the same time, maintain the quality of the study, so we get the anticipated outcomes of that study. So it's still -- our time lines are still -- it's like a 1.5-year study, 6 months endpoint. So results can be expected 2 years after we start the study. For CHI, you're correct that we're targeting 2 different age groups. So neonates from day 7, when just after they're born up to the age of 3 months and then children up to the age of 12. And it's basically 2 different key endpoints that we're looking into. For the neonates, it's really the opportunity to prevent a surgery having the pancreas removed by putting them -- putting these children on dasiglucagon infusions because they have -- at least many of these children are expected to grow out of the condition at the age of 6, 8 years old. Then for the older kids, it is patients who are kept who have either undergone partial surgery and then kind of maintained on standard of care or other medical more exploratory treatment. And that's why we want to go in and show for these children we can reduce the number of hypoglycemic events and severity of living with this disease until they grow out of the disease. And we -- I mean, the key thing here is where we will, of course, by far create the biggest, you can say, transformation for these children is in the neonates because we prevent surgery, but the older children will contribute also to the safety database and understanding how to use this treatment in the long run. So that's why we believe the 2 studies together will allow us to get a very attractive label, ultimately, for treatment of these patients. For dual-hormone, artificial pancreas -- I actually did get your -- the question and I've provided an answer, but you were off, but I could just say it's a 4- to 6-week or 8-week study where we will test the iLet using dual hormones versus running in a single-hormone mode. So it's the first time where you can say ever where you will show the true clinical proof of concept for what a dual-hormone system can deliver over a single-hormone system. So for us, it's really a milestone study, which will shed light on the true potential value of dasiglucagon in these systems. And furthermore, this study will also serve the basis to go into Phase III studies together with our partners.

Coming back to the CHI part, do you think that -- will you be starting them both at the same time this year? And then, are both needed -- do you think both are needed -- success is needed in both of them for regulatory approval in the U.S.?

Yes. I mean, definitely, we anticipate to start both studies at more or less the same time. So they are -- we're in full planning mode for initiating both studies. There might be a few months difference between when you get them started for logistical reasons, but we actually have a goal to start both studies. And then we're planning -- waiting on getting both of them started. What will be required, ultimately, to -- for approval will depend a little bit on the data that we generate because, I mean, this is an ultrarare indication with an extremely high on medical need. So -- and of course, if we can show that we prevent surgery in 16 neonate children, you might ask how much more evidence do you need to actually get this product on the market. I mean -- and these are dialogues we will have to have with the regulators once we get a little bit further into the clinical studies. So I think I cannot be more specific at this time point.

(Operator Instructions) As we appear to have no further questions, I would like to turn the call back to the speakers for any additional or closing remarks.

Thank you, and thanks for the good questions and to everyone for joining the call. I wish you all a good rest of day.