Zealand Pharma A/S

OTC:ZLDPF

Earnings Call Analysis

Stable Revenue, Tight Expenses Forecast

In Q1 2023, revenue reached DKK14 million, largely due to Novo Nordisk's Zegalogue deal. Operating expenses were DKK182 million, with R&D below last year's figures following a 2022 restructuring. A net loss of DKK27 million was reported, attributed to loans and partnerships agreements. As of March 31, cash reserves stood at approximately DKK1 billion. Through capital raising and restructuring, including repaying Oberland Capital's loan, the company secured its financial position, extending its cash runway to mid-2026. Maintaining previous guidance, projected operating expenses for 2023 are DKK800 to DKK900 million, with no specific revenue forecast due to uncertainties but expecting near-term milestones from partners.

Zealand Pharma Q1 2023: Advancing in R&D and Strengthening Financial Position

Zealand Pharma's Interim Results for the First Quarter of 2023 showcased progress across their product portfolio, especially in rare diseases and obesity treatments. CEO Adam Steensberg emphasized a year of milestones marked by solid R&D advancements, a sturdier balance sheet, and streamlined operations, despite a challenging financial landscape.

Strategic Focus and Clinical Updates

The company is focused on regulatory submissions for rare disease treatments and shared that the New Drug Application (NDA) for Dasiglucagon, intended to manage Congenital Hyperinsulinism (CHI), is set for submission in Q2 2023. Similarly, Glepaglutide for short bowel syndrome is on track for regulatory submission in the latter half of the year, with positive data from ongoing trials bolstering this direction.

Innovative Pipeline and Promising Obesity Portfolio

Zealand's obesity portfolio contains novel assets targeting various pathways for weight management with dual pharmacology and single receptor approaches. Key results from trials include BI 456906, a glucagon GLP-1 receptor dual agonist, with up to 14.9% weight loss achieved over 46 weeks and amylin analog ZP8396 showing notable weight reductions in lesser timeframes. These therapies present major opportunities for addressing obesity with potential multiple treatment combinations.

Financial Performance and Outlook

Zealand Pharma posted revenue for Q1 2023 of DKK14 million, driven mainly by the agreement with Novo Nordisk, against operating expenses of DKK182 million. The company has proactively bolstered its financial standing with a DKK1.5 billion capital raise and a strategic refinance, resulting in an extended cash runway until mid-2026. The guidance remained steady, forecasting operating expenses between DKK800 million to DKK900 million for the full year, without providing specific revenue guidance due to the unpredictable timing and size of partnership revenues though expecting near-term milestone payments.

Looking Forward

Zealand Pharma anticipates completing a BI study this year and is expecting to report results early the next year. The revenue from Novo Nordisk was clarified as a mix of royalties and collaborative activities. Although they have not drawn on the DKK350 million Revolving Credit Facility from Danske Bank as of May, it is available to support their operations if necessary.

Earnings Call Transcript 2023-Q1

[Operator]

Hello, and welcome to the Zealand Pharma Conference Call. I would like to advise all participants that this call is being recorded. Thank you. I'd now like to welcome Anna Krassowska to begin the conference. Anna, over to you.

[Anna Krassowska, executive]

Welcome, and thank you for joining us today to discuss Zealand's interim results for the first quarter of 2023. With me today are the following members of Zealand's management team, Adam Steensberg, President and Chief Executive Officer; Henriette Wennicke, Chief Financial Officer; and David Kendall, Chief Medical Officer. You can find the related company announcement and interim report on our website at zealandpharma.com. As described on Slide 2, we will be making forward-looking statements that are subject to risks and uncertainties. With that, I will turn the call over to Adam Sabre, President and CEO. Adam?

[Adam Steensberg, executive]

Thank you, Anna, and thanks to everyone for joining today. I'll begin on Slide 3. We are now 1 year into my tenure as CEO at Zealand, and I'm very proud of what we have achieved. With a strong focus on R&D, we have successfully progressed our product candidates within both rare diseases and obesity. And despite the turbulent financial environment, we have significantly strengthened our balance sheet and streamlined operations. The strong momentum has continued into the first quarter of 2023. In our [ obesity ] portfolio, we achieved impressive clinical results in 2 key programs. We are very encouraged about the clinical outcome announced yesterday with Boehringer Ingelheim for the dual glucagon GLP-1 receptor agonist BI-456906 and excited about BI's regulatory interactions on Phase III initiation.

Our amylin analog ZP8396 showed profound reductions in body weight after 1 week in the single ascending dose trial and is now progressing well in the Phase Ib multiple ascending dose trial. Importantly, we have also strengthened our balance sheet with the DKK 1.5 billion from a direct issue in April, bringing on board a broad group of specialist investors, we now have a cash run rate to mid-2026.

Moving to Slide 4. We remain focused on our strategic objectives and are [indiscernible] catalyst reached 2023. We are on track for 2 regulatory submissions in our rare disease programs. The first submission is expected here in the second quarter for dasiglucagon in babies and children with congenital hyperinsulinism or CHI. The second is for glepaglutide in people living with short bowel syndrome and intestinal failure expected in the second half of the year. We expect to see the strong momentum continuing with our [indiscernible] assets, including upcoming clinical data presentations and initiation and reporting of new clinical studies across the portfolio. Our strategy to pursue partnerships remains on track, and we will seek to continue to participate in the programs across the value chain where we can leverage our strengths and capabilities to maximize the value of each asset.

Advancing to Slide 5, I will now turn over the call to our Chief Medical Officer, David Kendall, to discuss the recent top line results and our R&D pipeline. David?

[David Kendall, executive]

Thank you, Adam. Today, I will focus my remarks on the recent top line results from our obesity portfolio. But first, I would like to provide a brief update on our 2 rare disease programs, where we continue to focus on plans for regulatory submission.

Turning to Slide 6. We are on track to submit the NDA for dasiglucagon in the management of CHI during this quarter. We believe that dasiglucagon can be an important potential treatment approach to this rare and devastating disease. And this program represents a significant opportunity for Zealand to address a major unmet medical need for these children and their families.

Please turn to Slide 7. Shown here is a schematic of our EASE Phase III clinical program for glepaglutide, our long-acting GLP-2 analog that is being developed for the treatment of short bowel syndrome and intestinal failure. We recently presented the results from the EASE 1 pivotal trial at the ASPEN and DDW Scientific Congresses and these data were very well received. We recently completed the interim data cuts of EASE 2 and EASE 3 long-term extension trials as well as from the EASE 4 study assessing long-term effects of glepaglutide on intestinal fluid and energy uptake and results from all of these studies will be included in our planned regulatory submission. We are currently planning for pre-NDA interactions with the FDA later in the summer, and we remain on track for a potential regulatory submission for glepaglutide in the second half of this year.

Turning now to our obesity portfolio on Slide 8. We are pleased to have a rich and differentiated pipeline of novel assets for the potential treatment of overweight and obesity. As many of you are aware, obesity is a complex disease that is amenable to pharmacologic treatments that target a number of unique metabolic pathways. We are applying 2 specific approaches in Zealand. Dual pharmacology to target 2 receptors with 1 peptide and potent and differentiated single receptor agonist that can be used alone or in combination with other peptides as flexible use, loose combinations or co-formulations.

The detail on Slide 8 outlines our differentiated peptide obesity portfolio. Each peptide in our pipeline has been designed to target an important and established neurohormonal pathways that are known to play important roles in the regulation of body weight, including hunger and food intake, energy expenditure and composition and satiety, any one of which plays an important role in achieving weight loss. Our therapeutic approach aims to: one, achieve increased weight loss; and two, provide additional effects that address specific needs or comorbidities of obese and overweight individuals.

Turning to clinical data. On Slide 9, we summarized the very exciting top line Phase II clinical results with BI 456906 announced yesterday. BI 456906 is a glucagon GLP-1 receptor dual agonist, co-invented with Boehringer Ingelheim being evaluated as a potential treatment for people with overweight and obesity. We are exceedingly pleased with the clinical outcomes reported, which demonstrate up to 14.9% weight loss from baseline at week 46 based on the analysis of the planned maintenance dose or a signed dose with a safety and tolerability profile consistent with other incretin-based therapies. Importantly, this primary endpoint was based on the dose assigned at randomization, which was modifiable during dose escalation and assessed efficacy based on that assigned dose regardless of whether the planned dose was achieved during the final week 26 weeks of study.

Along with our colleagues at Boehringer Ingelheim, we are excited to share the full Phase II results from this dose finding study, including an analysis evaluating efficacy based on the actual maintenance dose used during the final 26 weeks, which indicates even greater weight loss. These data will be presented in their entirety at the upcoming American Diabetes Association Scientific Sessions to be held in late June in San Diego, California.

On Slide 10, we provide a summary of our novel long-acting amylin agonist. The islet hormone amylin is well known to play an important metabolic role and is a validated target for the potential treatment of obesity. Amylin treatment results in weight loss by reducing food intake and increasing satiety, and amylin is also known to restore leptin sensitivity, which may contribute to the maintenance of weight loss. In late March, we announced positive top line results from our Phase Ia single ascending dose trial of our long-acting amylin analog ZP 8396 or 8396. Healthy participants with a mean BMI of 25.8 were treated with a single dose of either subcutaneous 8396 or placebo across 7 dose cohorts. Those individuals treated with 8396 had dose-dependent reductions in mean body weight of up to 4.2% from baseline, while placebo-treated individuals had a mean body weight increase of 0.6%.

The plasma half-life of 8396 was 230 hours, which supports once weekly dose administration and treatment was assessed to be well tolerated in this study and detailed results of this trial will also be presented at the upcoming American Diabetes Association Scientific Sessions. In the second half of 2023, we expect to provide an update on the 6-week portion of the multiple ascending dose trial with 8396, a study that is currently ongoing. Our focus is also on the planned initiation of the 16-week portion of this Phase Ib trial in which we aim to evaluate higher doses than those used in the single ascending dose and the initial 6-week multiple ascending dose studies, and we will also include individuals with overweight and obesity in this trial.

We believe amylin agonism can play an important role, both as a stand-alone treatment for obesity, serving individuals who may not tolerate or adequately respond to current GLP-1-based therapies and amylin as a non-incretin hormone can be used in combination with other incretin-based treatments to provide additional weight loss. As we have previously shared, ZP 8396 is specifically designed to allow for either co-formulation or co-administration with other peptide-based therapies.

In closing and turning to Slide 11. I also want to provide a brief update on dapiglutide our first-in-class dual GLP-1, GLP-2 receptor agonist, a novel peptide that leverages the effects of a potent GLP-1 agonist with the effects of GLP-2. We are excited to explore the potential of this asset to not only achieve substantial weight loss but also target low-grade inflammation through improved intestinal barrier function. We recently initiated an investigator-led clinical study to assess these mechanisms. We also expect to initiate a 13-week dose titration Phase Ib study in individuals with overweight and obesity in the second half of 2023. We are both encouraged and extremely excited by the recent data readouts and the strong momentum across our development pipeline in rare diseases and obesity, and we look forward to providing additional updates as we advance our programs through 2023.

I would now like to turn the call over to our Chief Financial Officer, Henriette Wennicke, to review our first quarter financial results for 2023. Henriette?

[Henriette Wennicke, executive]

Thanks, David, and hello, everyone. Let's move to Slide 12 of the income statement. Revenue for the first quarter 2023 was DKK 14 million, mainly driven by the [indiscernible] and development agreement with Novo Nordisk for Zegalogue. The operating expenses for the period were DKK 182 million, driven by the progression of the [ late days ] rare disease assets and obesity programs. The R&D spend is slightly below Q1 last year due to timing of clinical activities.

Administrative expenses as well as sales and marketing expenses are, however, significantly below Q1 last year, [indiscernible] restructuring in March 2022. Net financial items for the period resulted in a loss of DKK 27 million, driven by the loan agreement with Oberland and the partnership agreement with Oberland.

Let's move to Slide 13 and the cash position. As of March 31, 2023, cash, cash equivalents and marketable securities were approximately DKK 1 billion. In April and May, we have taken significant actions to strengthen Zealand's balance sheet. Firstly, in April, the [indiscernible] rates gross proceeds of DKK 1.5 billion from a direct issue and private placements of new shares. Secondly, in May, we fully repaid the loan facilities with Oberland capital. The Q2 cash effect as the final repayment will be a net outflow of USD 77 million and with this, the loan agreement Oberland is fully terminated.

Thirdly, the repayment of the obligation with Oberland is refinanced through a new DKK 350 million revolving credit facility provided by Danske Bank and expected near-term upcoming milestones from existing partners. With these actions, Zealand now holds a much stronger balance sheet and a cost runway to mid-'26. This will allow us to continue to invest in progressing our rich R&D pipeline.

Let's move to Slide 14 and our financial guidance. Our guidance is unchanged, and we continue to guide for net operating expenses of between DKK 800 million to DKK 900 million in 2023.

We will, as Adam said, also engaged in partnership discussions this year, in line with our strategy. However, we do not provide guidance on revenue anticipating from system and new license and partnership agreements due to the uncertainty related to time and built at the size of such revenue. That said, we do expect to receive milestone payments from existing partners in the near-term. And with that, I will turn the call back to Adam.

[Adam Steensberg, executive]

Thank you, Henriette. These first months of 2023 were exceptional for Zealand Pharma and in closing, I would like to thank all our employees for their dedicated work towards achieving our strategic priorities. Likewise, we appreciate our partners for the strong collaboration and our current and new shareholders for the continued support and trust.

Finally, I would like to express my sincere gratitude to those who are participating in our clinical studies. Thank you all. I will now turn it over to the operator for questions.

[Operator]

[Operator Instructions] Your first question comes from the line of Charlie of Morgan Stanley.

[Unknown Analyst]

Charlie Ma from Morgan Stanley. So firstly, [ Pete ] could you provide any context around how the weight loss curves were trending in the Phase II study at 46 weeks? Do you think there is any more weight loss to go. And secondly, Pete, could you provide an update on your discussions for the dasiglucagon partners in CHI as you approach filing.

[Adam Steensberg, executive]

Thank you, Charlie. So first of all, on the BI collaboration for our glucagon GLP-1, we cannot share more data before ADA as we have communicated, we look very much forward to the conference and to discuss the data at that time. I would say, if you look at other incretin-based therapies, then of course, you can expect additional weight loss with time that has been seen with any -- all other incretin-based therapies but we cannot discuss the specific data in more details, except as David said before, that we are highly encouraged with what we have seen so far.

On the dasiglucagon CHI partnering discussions, we are where we want to be. As we have communicated, we -- our plan is [ all time ] then to get the NDA package completed and ready for submission. And then engaged -- start engaging in confidential discussions with potential commercial partners. So those are progressing as planned right now, and we also expect to open data room in the near-term. and after then engage in more specific discussions. So things are progressing well and according to plan there. Thank you.

[Operator]

Your next question comes from the line of Michael Novak of Nordea.

[Michael Novod, analyst]

It's Michael Novod from Nordea. Also a couple of questions. Maybe just to give us just a bit of feeling around how your investments are being done in R&D. How much are you actually putting into [ obesity ] this year? And what is sort of the plans going forward? Because it's obvious that probably need to invest in order to also gain more data and also try to do deals at some point in time for some of the earlier assets?

And then secondly, on dapiglutide, the GLP-1, GLP-2. Can you talk about sort of the ratio between GLP-1 and GLP-2. You gave us the ratio on the BI 45 for GLP-1 versus glucagon maybe it just be nice for us also to get the ratio around GLP-1. GLP-2.

[Adam Steensberg, executive]

Thank you, Michael. I will just shortly answer your second question first, and then I'll hand over to Henriette. We have not released the specific ratio that we will provide at coming scientific conference. And so we cannot comment any details on it, but I can highlight that our approach for these dual acting peptides has been to make sure that they are biased towards activity on the GLP-1 receptor to make sure that we harvest the known benefits of GLP-1 and then just adding a little bit of additional pharmacology just as we did with the BI compound.

So you will have to wait with further data and specific data for this compound until that conference, but it's the same concept we are trying as we did with the glucagon GLP-1. Henriette will you take the other?

[Henriette Wennicke, executive]

Michael, thanks for the question. So clearly, we are investing heavily in obesity, and we are putting all investments into progress our obesity assets. Clearly, at this stage, as we are progressing towards NDAs for rare disease assets -- these are also driving a lot of the cost you see we are burning currently. But clearly, as we file these, we will also, in the future, invest significantly more into our obesity assets as the progression. But clearly, everything we can put behind them we do at the moment.

[Operator]

Your next question comes from the line of Jesper of Carnegie Investment Bank.

[Jesper Ilsoe, analyst]

Yes. Firstly, on your GIP assets, can you just provide some thoughts on this program, given what we saw with Novos [indiscernible]. We didn't show any benefits on [indiscernible] and weight versus [ semi loans ] just updated thoughts and whether or not you see this as impacting potential interest in this asset. Then secondly, on the BI data, I understand you cannot comment to the detail, but perhaps it's just conceptually why didn't all patients in the treatment reached maintenance dose in the 46-week study just to understand why the potential reasons for that because I would assume that there's plenty of time for it? And then I have a follow-up.

[Adam Steensberg, executive]

Thank you, yes. I will just start, and then I'll hand over to David for further comments. On the GIP, I want to mention that we have to be -- it has to be -- you can we have to bear in mind that all molecules are different. So -- and therefore, we are still excited about our GIP molecule when we evaluate our preclinical evidence. And we don't have more insights into the Novo program than what was released a few days back. And there could be specific reasons why they decided to prioritize differently in their pipeline. But we have confidence in our molecule based on the preclinical data, but as we have also said that clinical evidence for GIP as such remains to be established.

And then again, on the BI program, we cannot comment too much more, but I will leave it to David to both provide further comments on GIP and also if we can provide more nuance into the BI study. But it is really [ per BI ] to provide these data at ADA. So we have to be a little bit mindful of that. David?

[David Kendall, executive]

Yes. Thank you, Adam. And Jesper, thanks. GIP, obviously, we, like you saw these decisions from Novo on one of their programs. Interestingly, as I think you know, they're continuing another program on the oral side with the combination of GLP-1 and GIP. As Adam said, we are quite pleased with our GIP agonist based on the nonclinical data, which we presented in some detail at last year's obesity week meetings.

And given the complexities now of GIP [ tirzepatide, ] presumably carrying an agonist component in that molecule, the Amgen asset an antagonist to GIP. I think there is likely much to be learned about the pharmacology of GIP. And clearly, based on those data from Lilly and Amgen and our own nonclinical data, we believe that GIP still has a very important potential role as an adjunct to other incretin and non-incretin based therapies. But obviously, we're looking very closely at what data will be made available from the Novo program to make decisions on our own.

On the BI asset, as Adam said, we are both mindful of and respectful of the embargo that's the American Diabetes Association is placed. So granular detail on that program and the protocol can't be provided. But suffice it to say that Phase IIb is, most importantly, dose-ranging dose finding activity to ensure that we have an understanding of both the dosing and the titration scheme. And in this program, like many others, there was an opportunity for the investigators to modify the titration during the active titration scheme.

The details of this will be outlined in the full numbers of subjects in what is essentially an intention to treat versus per protocol populations. We are excited to share at the upcoming scientific session. So without preempting that presentation, that's the detail. Maybe an example is if someone had potentially tolerability issues that would give the investigator's discretion in this and other Phase II dose-ranging studies to alter that titration scheme so that we have a better understanding to inform the full Phase III program once those decisions are made.

[Jesper Ilsoe, analyst]

Okay. Perfect. Just one additional question on glepaglutide, for me. So just perhaps you can put some additional comments on the [ note ] in your report about additional patients weaning of parental support. As well as whether or not these long-term extension study is what you've seen so far, that's more confident on the potential with glepaglutide.

[David Kendall, executive]

Yes. I'm happy to start Jesper and yes. And Adam, if you have additional comments, I'll turn it back to you. But certainly, we're excited by having at least our initial look at the data readouts from the long-term extension. Both trials are ongoing. We've made the interim data cuts in both extension trials.

And I'll just summarize by saying we're both very pleased and the results are consistent and continued clinical effect is certainly being observed, again, without preempting all of the full data sets the issues of enteral autonomy and continued reductions in PS. Those results are certainly very encouraging. And we think continue to add strength to the results of EASE 1 and additional safety exposure, obviously, which is important for the ultimate regulatory submission. Adam, any additional comments from you?

[Adam Steensberg, executive]

No. Thanks, David.

[Operator]

Your next question comes from the line of Peter Welford of Jefferies.

[Unknown Analyst]

I've got 4 very quick ones. Firstly, I'm sorry if I'm being stupid about this, but just coming back to the 906 maintenance [indiscernible] and I'm not asking for the data, but just so I could understand. Are we saying then that the planned maintenance dose is basically a protocol [indiscernible] for those people that didn't make it to the dose they were assigned are not included. Whereas the actual maintenance doses in ITT, so patients are included regardless of what dose they got to in that arm to actually some patients in the ITT analysis would be on a lower dose than was originally planned, but actually you're getting more weight loss when you do the ITT analysis, including those patients. Is that right? Secondly then -- sorry, sorry. I on, sorry, the -- go ahead.

[Adam Steensberg, executive]

Peter. I'll just follow up on David's note, and then we really have to be mindful of how the data is [ embargoed. ] But I think it's -- what is important to understand is the key element is that when you design these Phase II studies, of course, you can just -- you can design them just to try to achieve the most weight loss that you want or you can design them to best inform the decision-making for how to design Phase III.

And then, of course, given way to evaluate these data sets. And data that we have released here for the -- that came out yesterday are on the -- from the patients based on the groups that they were randomized into and in order to -- you can say, following the dosing titration period, the first 20 weeks, investigators were allowed not to truly get up to the highest dose. And you can say the date that will come later at ADA is an analysis of those patients who actually was put up to the highest dose and then maintained on that for the remainder 26 weeks of the study.

And of course, when you do Phase III studies, you will design it a little bit different, these kind of things. I mean you will not keep a fixed dose after 20 weeks and so on. So we are extremely encouraged by the data, and we look very much forward to share them. But I really think we need the full data set to understand the details more.

[Unknown Analyst]

Yes. Sorry, sorry, I got it. So yes, so what we're saying is your -- when you say the actual maintenance dose, so what we're saying is the per protocol, in other words, the people are actually did...

[Adam Steensberg, executive]

These are patients who were dosed up to the dose that they were randomized to.

[Unknown Analyst]

Yes, yes. Got it. Okay. Fine. Okay. And then just secondly then, just on the NASH study. Am I right in saying we're still anticipating NASH data later this year for 906?

[Adam Steensberg, executive]

We take that, David, on the NASH Phase II study.

[David Kendall, executive]

Yes. So the NASH Phase II study, Peter, is fully enrolled and the data continue to be accumulated. So we await future data readouts when the last patient last visit and obviously, the database is locked. So the diabetes -- or the -- I'm sorry, the obesity study that will be presented at ADA is that, that was specifically designed to assess weight management and overweight in obese individuals.

So the NASH study is forthcoming and ongoing, fully randomized, and we look forward to those results upcoming.

[Adam Steensberg, executive]

No. [indiscernible] is guiding that they expect to complete the study this year and then we don't know when it will be reported, but like early next year.

[Unknown Analyst]

Got it. Okay. And then just so I understand the -- on the financials, just 2 very quick ones. Firstly, the income booked from Novo in the revenue line, the DKK 13 million is that all a straight royalty income? Or is some of that 13 money Novo is paying for drug or something else from the residual? Just trying to understand how we should think about that going forward?

And then just on the revolver, Curious, have you actually pulled down the DKK 350 million revolver in May to pay the Oberland or is that just a facility that's available to you? I guess given your cash balance, it doesn't seem immediately obvious necessarily why you pull on the revolver now given DKK 2.5 billion available to the raise?

[Henriette Wennicke, executive]

Thank you, Peter. Henriette here. Let me comment on that. So Novo is a split of royalties and other activities we are conducting together with Novo. So that will be a split you can say hitting the top line there. In regards to the revolving credit facility, you're right. We are not growing it down at the moment, but is available to us, which I think is an important point. And I think it is a system that we can actually establish a revolving credit facility at this point in time. And of course, the terms are significantly different from what we had on the previous facility we have in place.

[Unknown Analyst]

That's great. Sorry, can you give us any sort of idea of -- because obviously, Novo is probably -- we probably never going to report [ Zegalogue ]. Could you give us some sort of idea, I mean what proportion is royalty. I guess I'm just curious, when we think about 2Q, 3Q, 4Q, I mean, how should we think about at all what you booked in 1Q? As in any way, recurring, if you like? Or is there any proportion or something you can give of a royalty to help us.

[Henriette Wennicke, executive]

Yes, of course, we cannot comment on the specific details here. But I think, of course, it is a mix. And you're right. At the moment, the level is [indiscernible] but it is a mix. So we cannot comment on the details of the contract is how much is booked as its royalties and how much is other activities we are conducting. But we are progressing towards the filing in Europe. And that's, of course, also included in the numbers, activities that's conducted under that agreement.

[Adam Steensberg, executive]

And Peter, maybe just for me to follow up. I think compared to all of our other activities in the pipeline, both in rare disease and obesity, at least near-term, we do not see this as being very material numbers for Zealand Pharma but it's an important agreement and it's an important product for the patients, we believe, but it's not a very important material that and we would not expect that to change significantly near-term.

[Operator]

Your next question comes from the line of Rajan Sharma of Goldman Sachs.

[Rajan Sharma, analyst]

Hello. Can you hear me?

[Adam Steensberg, executive]

The connection is really bad right now. Just give us one second. And try again. Can you try again to.

[Rajan Sharma, analyst]

Sure. Is that better?

[Adam Steensberg, executive]

It is.

[Rajan Sharma, analyst]

Okay. Perfect. So first one amylin, just -- could you help us think about what your expectations are for the MAD data in the second half of the year? Are you looking for weight reductions in line with what we saw in the single ascending dose? And then just on that asset and kind of you talked about amylin and the potential for combinations. When might you think about combination trials for your amylin agonist? And then just one on the GLP-1 glucagon coagonist. What are you thinking about kind of acceptable levels of GI-related AEs.

I think there was some comments in the media by your partner, BI, yesterday that talked about the AE profile being in line with what we've seen with other kind of commercial and late-stage obesity therapies. So could you just help us think about that?

[Adam Steensberg, executive]

So I will -- thank you for the questions. On the amylin I mean, I think we should not speculate too much because data is always data and the study is ongoing, but it's fair, and David, you can comment more on this in a minute, but it's fair to say that, as David also mentioned, it's a 2-part study the multiple ascending dose first 6-week study and then moving on to a 16-week so I would say the focus for us at the 6-week study is to serve as a bridge towards getting the 16-week study starting where we also have higher doses.

So -- but of course, you can say we would anticipate weight loss also in the 6-week study since we observed after only one dose. And after 1 week, 4.2% weight loss in the single-ascending-dose study. So -- but David, you can comment more on that. On the BI collaboration on side effects, I think we will stick with the note that BI put out, and I think we agree very much to it. [ GLP-1 ] alone for its [ salability ] issues, which can also be managed by titration to a large extent. And I think with how BI position this. This is also our view, and then the specific data is sorry for that, but it's again, ADA. David, any comments or further elaborations.

[David Kendall, executive]

Yes, I think just to add some flavor to the amylin question, Rajan, I think qualitatively, given what we saw in single ascending dose would certainly anticipate even in the MAD part 1, as we describe it, the 6-week study to hypothesize that they would be results that are qualitatively similar to Adam's point, the second component of that, which is longer duration including individuals who are overweight and obese and titrating to higher doses, again, to inform Phase II planning we hope will give us a much broader brush of both the clinical response and the dosing regimen that we may be applying in future studies.

So I don't want to get ahead of ourselves and speculate on the actual numbers. As regards combination trials, as you know, the regulatory path is somewhat sophisticated so our near-term plans are to take this forward as a stand-alone asset to better understand its individual contribution. But obviously, there's an opportunity, particularly with other approved assets for the management of obesity on the market to assess these in combination in later phase trials. So those are considerations, but the focus in the near-term is for the monotherapy assessment.

And to Adam's point, I think we've seen both with higher dose [ tirzepatide, ] higher dose [ semaglutide ] sort of the broad brush of what happens at the GI side effects as you have more potent or higher exposure to GLP-1 agonism and I'll stick with the BI comments as well that the results we have seen and we'll report in just a few weeks, are certainly consistent with those.

[Operator]

[Operator Instructions] There are no further questions at this time. I would like to turn the call back over to Adam.

[Adam Steensberg, executive]

Yes. I don't know if you can hear us. I think we lose connection again a little bit. But if you can, then we would like to thank you all for attending and for your questions today, and we look very much forward to connecting on future announcements and updates. Thank you all. Over to you, Ray.

[Operator]

This concludes today's conference call. You may now disconnect.