Earnings call transcript: Zealand Pharma Q4 2024 focuses on obesity pipeline

Zealand Pharma A/S ADR (NASDAQ:ZEAL), with a market capitalization of $7.5 billion, recently held its Q4 2024 earnings call, emphasizing its strong focus on obesity treatments and product innovation. The company reported a full-year revenue of DKK 63 million, with significant investments in research and development. Despite the absence of specific earnings forecasts, Zealand Pharma’s strategic initiatives in obesity treatment have been a focal point for investors, driving its stock up 58% over the past year. According to InvestingPro analysis, the company appears to be trading above its Fair Value, though it maintains strong momentum with a Price Momentum Score of 4.25 out of 5.

Key Takeaways

• Zealand Pharma’s full-year revenue reached DKK 63 million.
• The company is heavily investing in obesity treatment research, with three key assets in development.
• Zealand Pharma ended the year with a cash position of DKK 9 billion.

Company Performance

Zealand Pharma has shown a strong commitment to developing obesity treatments, with a notable increase in R&D expenses, which accounted for 69% of its operating expenses. The company also reported a significant improvement in net financial items, achieving a net gain of DKK 189 million compared to the previous year’s net loss. These financial metrics underscore Zealand Pharma’s strategic focus on long-term growth in the obesity treatment market.

Financial Highlights

• Full Year 2024 Revenue: DKK 63 million
• Net Operating Expenses: DKK 1,330 million
• R&D Expenses: DKK 920 million
• Cash Position: DKK 9 billion as of 12/31/2024

Outlook & Guidance

Zealand Pharma has provided guidance for 2025, with operating expenses expected to range between DKK 2.0 billion and DKK 2.5 billion. The company plans to continue its investment in obesity and inflammation research, with three large Phase 2b trials expected to be underway. Additionally, Zealand Pharma is preparing for potential Phase III initiation and exploring partnership opportunities for its obesity treatments.

Executive Commentary

CEO Adam Steinspa emphasized the company’s strategic positioning in the obesity market, stating, "We have created a very strong platform for accelerated growth and our pursuit of our ambition to become a key player in the growing obesity space." He also highlighted the significant unmet medical need for improved weight loss therapies, noting, "We believe there is significant unmet medical need for therapies that can deliver the same degree of weight loss as the GLP-1 receptor agonist, but with improved tolerability."

Risks and Challenges

• High R&D Expenses: Continued high investment in R&D could impact short-term profitability.
• Market Competition: The obesity treatment market is competitive, with many players vying for market share.
• Regulatory Hurdles: Navigating clinical trials and regulatory approvals can pose challenges.
• Economic Conditions: Broader economic conditions may impact funding and market demand.

Zealand Pharma’s strategic focus on obesity treatments and strong financial position suggest a promising outlook, despite the challenges inherent in the competitive and regulatory landscape of the pharmaceutical industry.

Full transcript - Zealand Pharma A/S ADR (ZEAL) Q4 2024:

Conference Operator: Good day, and thank you for standing by. Welcome to the Zealand Pharma Results for Full Year twenty twenty four Conference Call. At this time, all participants are in a listen only mode. After the speakers’ presentation, there will be a question and answer session. Please be advised that today’s conference is being recorded.

I would now like to hand the conference over to your speaker today, Anna Kraszowska, Head of Investor Relations. Please go ahead.

Anna Kraszowska, Head of Investor Relations, Zealand Pharma: Thank you, operator. Welcome and thank you for joining us today to discuss Zealand Pharma’s results for the full year 2024. You can also find the related company announcements and annual report on our website at Zealandpharma.com. As described on Slide two, I caution listeners that we, during this call, will be making forward looking statements that are subject to risks and uncertainties. Turning to Slide three and today’s agenda, with me are the following members of Zealand Pharma’s management team: Adam Steinspa, President and Chief Executive Officer Henriette Abinneker, Chief Financial Officer David Kemble, Chief Medical (TASE:BLWV) Officer.

All speakers will be available for the Q and A session along with Eric Cox, Chief Commercial Officer. Moving to Slide four, I will turn the call over to Adam Stainsborough, President and CEO. Adam?

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thank you, Anna, and thanks to everyone for joining today. 2024 was a transformational year for SINA Pharma with significant clinical advancement across our differentiated obesity pipeline. We were excited to share positive data and progress with the TRINITY1 TLB2 receptor dual agonist and with servitotide, a potential best in class Kluagun tier B1 receptor dual agonist that is being developed by Boehringer Ingelheim. Turning to Slide five. Zealand has an ambition to become a key player in the growing obesity market.

And in 2025, we will expand our investments in and continue to focus on delivering on our differentiated mid to late stage obesity pipeline. Furthermore, we remain committed to advance our late stage rare disease programs in congenital hyperinsulinism and short bowel syndrome, where patients are in urgent need for better treatment options. And finally, we are progressing our early stage pipeline of next generation peptide therapeutics in the inflammation space. Moving to Slide six. I would like to take a step back and remind everyone why we are so strongly focused on developing new treatment options for people living with overweight and obesity.

The obesity pandemic has evolved in just fifty years. We have witnessed a substantial increase in the global prevalence of overweight and obesity rising from about ten percent in the 70s to forty percent to fifty percent today. More than five million deaths globally are today ascribed to overweight and obesity every single year. We are still in the very early stage of the evolution of the obesity market. And in The United States today, only two percent approximately of eligible patients get pharmacotherapy.

The important point on obesity is not only whether you are obese or not, but for how long you have been living with obesity. For many, there is a limit to how long organs can compensate for the effects of obesity before they begin to fail. We know that more than two twenty complications and comorbidities are associated with obesity. With the substantial increase in prevalence of overweight and obesity also among children, I fear that in the coming decades, we will see a significant increase in the prevalence of obesity related comorbidities. The good news is that we now have the first tools available to help address this global healthcare challenge, but we do need many more and better treatment options for the very large and diverse population living with overweight and obesity.

This leads me to Slide seven. We have seen the approval and successful rollout of the first two once weekly GLD1 based therapies to address the global healthcare challenges. In Phase III clinical trials of longer duration, they have demonstrated potential for fifteen percent to twenty one percent mean weight loss in patients with overweight and obesity and positive outcomes on several obesity related comorbidities. On the flip side, TRD1 based therapies are often associated with a number of gastrointestinal adverse events including nausea, vomiting, diarrhea and constipation. And data suggests that up to thirty percent of patients with obesity on a GLP-one treatment stop within one month before reaching their target dose and that within one year, sixty percent to seventy percent of patients withdraw from treatment.

Therefore, we believe there is significant unmet medical need for therapies that can deliver the same degree of weight loss as the GLD1 receptor agonist, but with improved tolerability and acceptability, including lower frequency and milder severity of gastrointestinal adverse events, so that patients have a more positive experience and can better achieve and importantly maintain a healthy weight loss. Based on clinical data to date, we are confident in the best in class potential of our long acting amylin analog, Petrinideside, that we are developing as an alternative to GLP-one based therapies with the potential to represent a foundational therapy for weight management in the future. And with that, let’s move to Slide eight as I turn over the call to our Chief Medical Officer, David Kendall, to discuss our R and D pipeline.

David Kemble, Chief Medical Officer, Zealand Pharma: David? Thank you, Adam. And once again, welcome, everyone. Today, I would like to focus my remarks on the continued advancement of our obesity programs and provide a brief update on other development and regulatory activities. Beginning with Petrolentide, let’s move to Slide nine.

As shown on this slide and as previously reported, Petrolentide has consistently demonstrated best in class potential based on results from early clinical trials completed to date. These data have shown consistent and compelling data with respect to both efficacy and safety as well as tolerability and have provided the evidence necessary to rapidly advance the development of petrelentide as a potential standalone therapy for overweight and obesity. Turning to Slide 10. In late twenty twenty four, we initiated a large and comprehensive Phase 2b trial with petrolantide in people with overweight or obesity, marking an important milestone for both the petrolantide program and for Zealand Pharma. Zucreen one is a randomized double blind placebo controlled dose finding trial comparing multiple doses of petrolantide or placebo over forty two weeks of treatment with five active dosing arms, the highest being nine milligrams.

As a reminder, the primary endpoint of percentage change in body weight from baseline will be assessed after twenty eight weeks of treatment, while the trial will continue for a total treatment duration of forty two weeks. To maintain trial integrity, we will continue to execute the trial in a blinded fashion throughout the entire treatment period. The separate team will be unblinded to the primary endpoint at 28 peaks solely for the purposes of advancing regulatory interactions with the goal of reducing the time between Phase two completion and the initiation of Phase three. Full unblinding and disclosure of data will only be after completion of the full trial. We are very encouraged by both the rate of study initiation and participant enrollment into ZIBREME-one.

In December 2024, we announced the enrollment of the first participant. Enrollment has been significantly faster than initially anticipated and we project the completion of enrollment by the end of this quarter. Let’s move now to Slide 11. In the first half of this year, we are continuing in our execution of the development program for petrelentide with the planned initiation of a second comprehensive Phase 2b trial. ZUPREME II is a randomized double blind placebo controlled Phase 2b trial of petrolotide in people with overweight or obesity and coexisting Type two diabetes.

In this population, data suggests that amylin agonism may potentially deliver weight loss comparable with that observed in the non diabetes population, another potentially important differentiation opportunity with amylin agonists as compared to GLP-one based therapies. ZUPREME II will enroll more than 200 adults and will compare three doses of petrolantide with placebo over an estimated twenty eight weeks of treatment, consistent with other clinical trials in people with overweight and obesity. The primary endpoint will be percent change in body weight from baseline, while key secondary endpoints will include change from baseline in hemoglobin A1c and change in fasting dapaglutide, our dual GLP-one GLP-two receptor agonist. Dapaglutide is designed as a potent GLP-one receptor agonist targeting significant weight reduction and offers the potential to also leverage GLP-two pharmacology and improve gut barrier function as well as targeting the low grade inflammation associated with metabolic disease. In 2024, we reported top line results from Part one of the Phase 1b dose titration trial with dapaglutide investigating the pharmacokinetic and pharmacodynamic effects of dapaglutide treatment with doses up to thirteen milligrams given once weekly over a treatment duration of thirteen weeks.

We are both excited and encouraged by these data and we look forward to presenting detailed results at a future Scientific Congress. In the first half of twenty twenty five, we look forward to reporting top line results from Part two of the Phase 1b trial designed to investigate doses of up to twenty six milligrams over a treatment duration of twenty eight weeks. We also plan to initiate a large Phase 2b trial with dapaglutide in people with overweight or obesity in the first half of this year. And with that, let’s turn to Slide 13. An illustrative overview of the proposed Phase 2b trial design is shown here.

This trial is planned to enroll more than 400 adults with overweight or obesity and will compare multiple doses of dapaglutide or placebo with up to five active treatment arms over a treatment duration of forty eight weeks. Consistent with other trials of incretin based therapies in people with overweight and obesity, trial participants will follow a dose schedule with monthly dose escalation steps. The primary endpoint will be percent change in body weight from baseline to week thirty six and the trial will include a number of key secondary and exploratory endpoints, including an assessment of biomarkers for inflammation, markers of cardiovascular risk and body composition. In this trial, we look very much forward to further evaluating the weight loss potential and tolerability of dapaglutide, while also gaining more insights into the potential of dapaglutide to reduce inflammation with the opportunity to target specific high risk populations. Turning to Slide 14 and servo dutide.

As reported in late twenty twenty four, Boehringer Ingelheim advanced servodutide, a dual glucagon GLP-one receptor agonist into two large registrational Phase III trials in people with metabolic dysfunction associated steatohepatitis or MASH. These two trials, LIBRIDGE in people with moderate or advanced fibrosis and LIBRIDGE cirrhosis in people with compensated cirrhosis are investigating the impact of this novel dual agonist on one of the most prevalent and serious obesity related comorbidities. And we are very pleased with the development progress of servodutide, a product candidate we believe holds potential as a best in class therapy for both obesity and MASH. We are also excited that in 2024, Boehringer Ingelheim has completed participant enrollment for SYNCHRONYZE I and II, registrational Phase III clinical trials of servadutide in people with overweight and obesity with and without Type two diabetes. If successful, servadutide could be the third to market incretin based therapy and the first dual glucagon GLP-one receptor agonist introduced in this exciting era of novel weight loss therapies.

Moving now to Slide 15 and a brief update on our rare disease programs. For DASIglucagon and congenital hyperinsulinism, we are prepared to resubmit Part one of our original NDA for up to three weeks of DASIGLUCOGAN treatment as soon as the issues at the third party manufacturing facility have been resolved in the form of a classification upgrade. Subsequent submission of Part II of the NDA for chronic treatment of CHI is planned thereafter. As previously communicated in late twenty twenty four, we received a complete response letter from the U. S.

FDA for the new drug application of lepaglutide for the treatment of short bowel syndrome with intestinal failure. We are working with the agency to align on the design and execution of an additional Phase III clinical trial, which will enable U. S. Regulatory approval. We expect to initiate the additional placebo controlled Phase III trial with glopaglutide, the EAS5 trial in the second half of twenty twenty five.

The EAS5 trial was already in planning for support of additional global regulatory submissions outside The U. S. And Europe, but will now be based on alignment with the U. S. FDA and designed to support our subsequent U.

S. Regulatory submission. Simultaneously, we anticipate submitting a marketing authorization application in the second half of twenty twenty five to support approval of glopaglutide in The EU. We remain deeply committed to doing everything we can to bring both of these treatments to patients living with these devastating rare diseases as soon as possible. And turning now to Slide 16 on our early stage pipeline.

I’m very pleased that we in late twenty twenty four progressed our first inflammation asset into the clinic. ZP9830 is a potent and selective KV1.3 inhibitor with potential to treat a broad range of cell mediated autoimmune diseases. The first in human clinical trial of CP9830 is now underway and we expect to complete the study by the end of twenty twenty five. This study is a Phase one single ascending dose trial investigating the safety and tolerability of ZP9830 in healthy male study participants. The study will also investigate the pharmacokinetics and pharmacodynamics of ZP nine thousand eight hundred and thirty as compared to placebo.

While 2024 was a year of significant progress in our development pipeline, particularly for our obesity assets, we also made significant advancements in our research pipeline as well, partly evident by the progress of ZP9830. In 2024, we also increased the number of research projects advancing to discovery and lead identification peptide therapeutics. In 2025, we will continue to enhance our early stage research effort with a particular focus on our Obesity Plus research pipeline of novel peptide targeting obesity and its distinct comorbidities. And with that, I would now like to turn the call over to our Chief Financial Officer, Henrietta Venneke, to review our financial results for 2024. Henrietta?

Henriette Abinneker, Chief Financial Officer, Zealand Pharma: Thanks, David, and hello, everyone. Turning to Slide 17 and the income statement. Revenue for the full year of 2024 was DKK 63,000,000, mainly

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: driven by

Henriette Abinneker, Chief Financial Officer, Zealand Pharma: the license and development agreement with Novo Nordisk (NYSE:NVO) for Sigilov. Net operating expenses in 2024 of DKK 1,330,000,000.00 were within the guidance of DKK 1,250,000,000.00 and DKK 1,350,000,000.00. Net operating expenses are driven by R and D expenses of DKK $920,000,000, representing 69% of the company’s operating expenses. The increase in R and D expenses compared to 2023 is mainly due to clinical advancement of the wholly owned BCT asset, pertilentine and dablutide, including preparation for large comprehensive Phase IIb trials and activities supporting the regulatory review by the U. S.

FDA for the rare disease assets. Selling and marketing expenses of DKK88 million in 2024 were mainly driven by pre commercial activities associated with launch preparations for the rare disease assets. And the increase in general and admin expenses is a result of additional legal expenses related to our cabin portfolio and strengthen our organizational capabilities and our IT infrastructure. Net financial items shows a net gain of DKK189 million in 2024 compared to a net loss of DKK137 million in 2023. This significant improvement mainly is driven by the interest income from the excess liquidity invested in Magogold securities.

Let’s move on to Slide 18 and the cash position. As of 12/31/2024, cash, cash equivalents and marketable securities were DKK 9,000,000,000. I’m very pleased with the fact that we ended 2024 with a cash position that was DKK 7,400,000,000.0 higher than when we started the year. We truly believe we have an R and D pipeline of promising and differentiated obesity. And our strong cash position enable us to significant scale up investment in development of these programs.

And this leads me to Slide 19 and the financial guidance. For 2025, we anticipate operating expenses to be in the range of DKK2.0 billion and DKK2.5 billion, which is a significant increase compared to 2024. This is mainly to support our mid stage obesity pipeline and enhance our early stage research efforts. As mentioned by David just now, by the end of twenty twenty five, we expect to have three large Phase IIb trials actively underway with our wholly owned obesity assets. One large Phase IIb trial with Pertuzentine was initiated in late twenty twenty four.

And in the coming months, we expect to initiate another Phase IIb trial with pertugentide. We also expect to initiate a large Phase IIb trial with aviclutide in the coming months. In addition to the clinical costs associated with conducting these mid stage in BCG trials, the 2025 OPEX guidance also includes CMT activities mainly related to API and drug product, but also activities to prepare for Phase III. Simultaneously, we are building the next wave of innovation peptide therapeutics. As mentioned by David, we significantly increased our research effort in 2024.

And in 2025, we will continue increasing investment in our peptide peptide research, including our early stage portfolio on novel peptide tied into obesity and inflammation. Lastly, moving to Slide 20, I would like to discuss our work with sustainability. While 2024 was a transformational year for Cymbal Pharma, it was also a defining year when it comes to our work with sustainability. We launched our first dedicated sustainability strategy, significantly increased our efforts to operate responsibly and build a sustainable organization while pushing for positive development of society. As a biotech company whose mission is to transform life through peptide innovation, we place the health and well-being of patients at the center of everything we do.

We remain firmly dedicated to advancing our R and D pipeline with focus on developing new and better medicines to serve patients. And our ability to advance our pipeline and ultimately serve patients rests on our people. Growing the number of headcount by 30% as Zealand has in 2024 can be a challenge for any company. We are extremely proud and humble that we maintained a very high engagement score of 8.8 on a 10 scale. And at the same time, we decreased our employee turnover rate to just 7.3% in 2024.

We believe this is a testament to our unique company culture and our continued dedication to foster an engaging and enriching workplace. We are confident that we have built a sustainable organization set up, and we look forward to continue to grow in 2025. We are also committed to taking responsibility for the environmental impact of our operation and lowering our green gas emissions. This year, we calculated our GSG emissions for both 2023 and 2024. As expected, our emissions lie in our value chain activity with over 99% of our emission coming from scope three.

In 2024, we developed a climate change transition plan and are establishing reduction targets to ensure that our activities are in line with the goals of the Paris Agreement. We remain dedicated to transitioning our company and working together with our business partner to mitigate climate change. And in 2025, we will formally commit to the Science Day target initiative. And with that, I will move to Slide 21 and turn the call back to Adam for concluding remarks.

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thank you, Henley. I’m extremely pleased and proud of our achievements in 2024. From the very solid organizational and financial foundation that we have built, we expect to accelerate momentum in 2025 with important clinical advancement of our differentiated obesity programs and significant progress in our early stage research pipeline. We have created a very strong platform for accelerated growth and our pursue of our ambition to become a key player in the growing obesity space and thus play our part in addressing what we believe is the biggest health care challenge of our time. We look forward to initiating the second planned Phase 2b trial with betreanetide in the first half of the year.

In the same timeframe, we also look forward to initiating a Phase 2b study in obesity with our potential first in class GLP1, GLP2 dual agonist, dapitlutide and announced top line results from Part two of the Phase 1b trial evaluating even higher doses of dapaglutide with longer duration. These are just some of the many activities that we look forward to in what we see to be a very busy and exciting year for SINA Pharma. Thank you all. And with that, I will now turn over the call to our operator for questions.

Conference Operator: Thank you. We will take our first question. The first question comes from the line of James Gordon from JPMorgan. Please go ahead. Your line is open.

James Gordon, Analyst, JPMorgan: Hello, James Gordon, JPMorgan. Thanks for taking the questions. Firstly, Petri partnership and the rate limiting factors for getting that done. So can you just confirm, do you think any more data might be needed either for your product or for competitor Amylin molecules? Might a potential partner want to see CAGRISEMA data presented?

Or if you think all the necessary data is now available, why wouldn’t a partnership, say, potentially happen in the coming months versus later in the year or even into 2026? Second question on partnership, just how important is it that you retain co promotion rights in The U. S. And or Europe versus who the partner is and what they can do for the product? And a final question, just to GlebA, just you mentioned the EASE5 study, which you need probably to get into The U.

S. When do you think that will read out?

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thank you, James, for your questions. I will start by addressing the first one and then yes, I can actually also address the last one. But if we start with the Petrinxide partnering, as you know, we started the process in the second half of last year, and it has been incredibly important for us to make sure that we have run a very structured process reached out to as many large pharma companies as possible, making sure everyone who were interested heard our vision for the program and then starting a dialogue with as many as possible. So we have had a very structured process. And what we also have been saying and what I I feel very comfortable saying today also is that we are exactly where we want to be in that process.

It’s not my sense that we are waiting for additional data, readouts or what have you. But for us, of course, if you are to engage in a long term partnership, it’s really important that you get it right. So the three parameters that we have set out for ourselves in the start remains the same. The partner has to be a large pharma company who have a vision of winning in this space in the 30s and not just be part of it, then we have to share the vision for petrinetide about becoming a foundational ultimately with the potential of a foundational therapy for weight management. And then of course, it’s extremely important also with the cultural fit, given that it’s a long term partnership.

And that’s kind of taking me back to one of the other questions you had, what is important for us in that partnership when it comes to the more structural elements. And we do think it’s important that it becomes a co development and co commercialization partnership with profit share. That is what we have pursued. That does not mean that we would have similar operational involvement or we would try to retain as much strategic flexibility as possible. But it is important that it’s a true collaboration and not one which is just a licensing agreement.

And I feel very comfortable that we can achieve that based on the dialogues we have. And I can also say that where we are right now, it’s not about engaging more parties. It’s probably more about narrowing the field down. So we are where we want to be. We do not guide on when we expect it.

I think that is not in anybody’s interest,

: but we are where we want to be on these discussions,

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: and we feel that it’s a very competitive situation. Ease V, again, we plan to start the study here in the second half. We will have an interaction with FDA on the exact details on some of the designs, and we will only communicate on when we expect results at a later time point. Thank you. Thank you.

Conference Operator: We will take our next question. Your next question comes from the line of Charlie Hayward from Bank of America. Please go ahead. Your line is open.

Charlie Hayward, Analyst, Bank of America: Charlie Hayward, Bank of America. Thank you for taking my questions. I have two, please. So the first is on your target, Petri fifteen percent to 20% weight loss. Given Cadre saw 12% weight loss, what’s your confidence in still being able to achieve the top end of that range, so the 20% weight loss and what drives that confidence?

And secondly, can you remind us of your plan and timelines for your PETRI Phase three trial discussion with regulators or the FDA? How do we expect to start those? And I think as you’re likely to be discussing fairly broad Phase III plans, including a CV trial with them from partner discussions you’ve had to date, do you think that’s a conversation that potential partners likely to want to be involved in? Thank you.

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thanks. I’ll just start and then I’ll hand over to David. Of course, you can say

: where we are

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: in the program, as David also mentioned on the Phase II enrollment, which is going incredibly fast, we need to start to think about Phase III planning sooner rather than later. And of course, it is relevant for any party to be part of that. So we see that and share that observation. But again, we do feel we are set up to also to deliver on those designs. But it is, of course, something that would be relevant to consider in these discussions.

David, will you address the our considerations about the 15% to 20% giving also the data earlier this year and perhaps some of the other elements?

David Kemble, Chief Medical Officer, Zealand Pharma: More than happy to, Adam, and thanks, Charlie. Yes, I think while the CAGRISIMA data left some with questions unanswered around both the CAGRIS dose and the impact of amylin agonists, I think that trial and those results to us gave us additional confidence in the potential of petrelentide. As you know and as we’ve shared previously, both cagrelentide and petrelentide are these balanced calcitonin amylin receptor agonists, which we believe is a critically important feature to achieve the greatest effects on body weight. In addition, petrelentide, we believe can be dosed at significantly higher milligram doses, which may support additional efficacy. Similarly, both the bioavailability and the activation, at least at the receptor level, is as good or in this case of bioavailability significantly higher than CAGR.

So while Phase II and twenty eight weeks of exposure may not take us to this target fifteen percent to twenty percent, which we would expect after a year or more of treatment. All of those features, the physical, chemical and pharmacokinetic, pharmacodynamic features of petrelentide give me and I hope others great confidence in achieving that fifteen percent to twenty percent. And I think as a reminder, people should review labels of the existing GLP-one based therapy for obesity, the data with semaglutide, where after more extended treatment, they achieved 14.9% to 16% weight reduction in their Phase III clinical trials. So we are often distracted or if you will recall things based on recency, which is the dual agonists and the other assets, which have achieved 20% or more. In terms of Phase III startup, premature to speculate, but obviously with completion of the Phase 2b studies and end of Phase two interactions with the agency, which we would anticipate would happen both near the end of this year and into next year.

Phase three startup, we hope will be enabled as quickly as possible in the coming year. And then finally, on your question on CBOT, obviously, this is a significant investment. We will want to see both Phase 2b data effects on markers of CV risk before that design is finalized. Although I can say we have initiated the early parts of that process already. And to your point pending the partner discussions, would obviously welcome a partner into these discussions when it occurs.

Charlie Hayward, Analyst, Bank of America: Many thanks.

David Kemble, Chief Medical Officer, Zealand Pharma: Yes. Thanks, Charlie.

Conference Operator: Thank you. We will take our next question. Your next question comes from the line of Michael Novot from Nordea. Please go ahead. Your line is open.

Michael Novot, Analyst, Nordea: Thank you very much. Michael Novot from Nordea. A couple of questions. So starting with the pigletide, can you sort of try to detail what you were just sort of hoping to see in terms of the twenty eight week data of twenty six milligrams in order to say that this is a qualifying candidate to move forward further with and where there could also potentially be partnering interest for this asset in terms of weight loss or other biomarkers? And then secondly, on glepaglutide, is there any reason to believe that EMA would not take the same stance as the FDA because the serial was clearly surprising?

So maybe you can go into a bit of more details on why we should not expect the same risk on an EMA approval or non approval? Thank you.

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thank you, Marco. I will just start with Debbie and then I will hand over to David. But on Debbie with qualifying of the waiters, I think it’s really important for us to kind of state that with Debbie, it’s not just about weight loss. We would look to weight loss that is similar to what we see from the currently available the ones out there like perhaps tesiputide like weight loss in long term studies. We already know for many patients that is actually enough.

And even in today’s market, many patients don’t take the top doses of the products that are available today. The key differentiator for Dabi is its potential on inflammation and low grade inflammation. So we are looking for weight loss that you can take it in the range of what we have today with, let’s say, a product like tesiputide and then, of course, ultimately, to have a differentiating opportunity when it comes to addressing low grade inflammation. David, do you want to add further to this and then also discuss CLIPA, please?

David Kemble, Chief Medical Officer, Zealand Pharma: Yes, absolutely. Thanks, Adam. And Michael, with DAPI, those biomarkers will be equally important, I will say. And one point to add to Adam’s is in many cases, the incretin based therapies in earlier studies have been tested only at lower doses. We see that with semaglutide looking at higher milligram dose exposures.

Tirzepatide, as Adam referred to, pushing to the fifteen milligram dose did occur in the clinical program. It’s in the label, but challenging for some to take. So for us, it is both to ensure we see the efficacy on weight loss and understand the tolerability at those top doses and across that dose range, understand the biomarkers. For glopaglutide, EMA certainly has a different set of requirements in terms of substantial evidence of efficacy. And we are obviously engaged with the European authorities and EMA

Thomas Franken, Analyst, KBC Securities: on

David Kemble, Chief Medical Officer, Zealand Pharma: outlining our submission package, Given the differences in requirements and in our eyes, what will be confirmatory evidence from these five, which will provide the FDA with the additional evidence they seek. We believe that the compelling evidence that was generated both for reductions in parenteral support and the enteral autonomy with the SYNLEASE one trial can in discussions with the EMA will serve as the information necessary for approval of this rare disease asset. So I think a number of things give me quite reasonable confidence that the EMA will give this a full thorough review with the existing data package.

Michael Novot, Analyst, Nordea: Okay. Thank you.

David Kemble, Chief Medical Officer, Zealand Pharma: Thanks, Michael.

Conference Operator: Thank you. We will take our next question. And the question comes from the line of Susan Van Vuzeutham from VLK. Please go ahead. Your line is open.

Anna Kraszowska, Head of Investor Relations, Zealand Pharma0: Hi, team. This is Suzanne from Kempen. Thanks for taking my questions. First on the paterinatide Phase 2b study that’s ongoing, fully understood that it remains blinded until forty two weeks. But I’m just wondering if we could expect some sort of communication from the company around the twenty week time point, not data, but for example, having reached this point or updates on the regulatory interactions.

And secondly, I was wondering if you can share your views with regards to Novo also starting a Phase three study with gigrelentide monotherapy. Obviously, petrelentide seems like a better molecule, but since there’s a change in Novo’s side to also develop this monotherapy, just wondering how you look at this. Thank you.

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thank you, Suzanne. And I will also start and then maybe David have a few extra remarks. But on the we do not anticipate to share any data from the twenty eight week data point. It will be a blinded review. It will probably be obvious from clinical trials as govern other places how where we are in the process.

But as that will be reported, but we will not share data or observations from that because it is a blinded study group that will look at it, so the rest of us will not have access. We have also, of course, noticed that following those full year results that they have put Cabrinetite Phase III planning on one of their pipeline sites. We think it’s a good support for the story and the positioning that we have been pursuing for petroInsight for a long time. As David has shared also with the data, we feel comfortable around the profile of petroInsight. We do believe we can achieve higher doses.

And you can say, of course, we see this as, again, validation of the approach that we have taken for some time that amylin monotherapies looks to have a potential for becoming very significant contributors to weight management, pharmacotherapeutic weight management in the future. And we are so far, it’s really an exciting observation and one which underscores the potential we have with Train Sight, which we truly believe is a best in class molecule. David, do you want to add some more flavor to this?

David Kemble, Chief Medical Officer, Zealand Pharma: Nothing further for me, Adam.

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Okay. Thank you, Suttam. Perfect. Thank you.

Conference Operator: Thank you. We will take our next question. And the question comes from the line of Prakash Agrawal from Cantor. Please go ahead. Your line is open.

Anna Kraszowska, Head of Investor Relations, Zealand Pharma1: Hi. Thank you so much for taking my questions. So maybe firstly a clarification, Adam. The press articles today morning are saying that you’re guiding partnerships by end of twenty twenty five, early ’20 ’20 ’6 versus you’re not commenting on timing here. So if you can clarify this please on the potential timing of partnership discussions?

And as a follow-up, discussion around amylin monotherapy versus combinations, how is that resonating with potential partners? And is there interest from companies that are not involved in the obesity space as you are working through the partnerships? Thank you.

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thanks for your questions. And I would say on your first question around partnership, I think we have been extremely clear and repeatedly including in all conversations we have had around this release that we do not guide on timing. We raised a lot of capital last year to make sure that we can pursue all the development efforts needed. We also started a partnering process last year. We are exactly where we want to be in this one.

But for several reasons, we have decided not to guide on timing for this. When people ask me and ask for my personal perspective, I also happy to say that it’s probably more likely to happen this year than next year. But that is also just based on an observation and some of these points we have discussed today that likely a partner would prefer to be part of Phase III design and Phase III discussions. And you basically need to partner up this year to do so. It’s not our observation that anyone are looking for more data.

But we are not going to guide on it and we have not changed any guidance on this also not in this call or today. On the mono and the combo therapy, I think there is a very big recognition of the monotherapy potential. It’s a really attractive, you can say, consideration to enter a market with a potential new modality where you don’t have to go in and fight for your share of an established market, but actually can tap into a novel market addressing patients who and with a novel modality and not just trying to take market share from something that is already quite established. So it is obviously the monotherapy that is creating the most excitement. Having said that, of course, that is a recognition of the potential of combination therapies.

I mean, Novo have already shown us both from a weight loss perspective what you can envision to achieve is that when you start to combine these. And we have a deep recognition also that there are, of course, segment of patients who need the higher weight loss. We are also just very firm that the majority of these individuals will not be looking for weight loss that is approaching 30%. The majority of patients will be looking for one which is around 15% to 20% weight loss. But of course, there are patients who need higher weight losses.

There’s also patients who may need that extra support during the weight loss phase and then less during the weight maintenance where a monotherapy could then come in. So we recognize the potential of those. That’s also why we plan to start a combination study later this year with the TRS1. But the most excitement is and remain on the monotherapy, the opportunity to create and develop the Trainside as a novel foundational therapy for patients. And then you can always add a little bit of GLP-one on top of that if the patients need more or need more in the weight loss phase.

Thank you.

Conference Operator: Thank you. We will take our next question. And the question comes from the line of Rajan Sharma from Goldman Sachs. Please go ahead. Your line is open.

Anna Kraszowska, Head of Investor Relations, Zealand Pharma2: Hi. Thanks for taking my question. And just on the partnering point, sorry to ask another one on this. But could you just kind of remind us how you think about the optimal timing for this partnership? I guess the question I’m trying to ask is beyond the additional capital that a larger partner may bring, at what point do they add value to Petrocentai’s development process beyond what Zealand can do alone, given that you probably have as much experience as any company with the mechanism itself?

And then secondly, sort of related to that, just on that combination trial with the GLP-one, is that likely to come after a partnership has been announced? Just trying to think about what the identity of that GLP-one partner could be Or is there potential to initiate a combination with DAPI? Thank you.

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: I think you’re going to get the goal for the most sneaky question because I just told you that we plan to start the GLP-one COMPUS study later this year. So that I cannot comment on if a partnership will be before or after we start the COMPUS study with GLP-one, but nice try. I would say on having coming back to the partnering process, we have had a very good process. We are exactly where we want to be. We have the conversations we want to have right now.

It’s not our feeling that we need more data. It is really and then you talk about what is the optimal timing. One thing is, of course, Phase III design. Another thing is, at one point, we also partner will have to consider manufacturing investments and so on. But again, we are not going to comment on timing.

But as you can imagine, we have a process and we have been following that process and we are exactly where we want to be on it.

Anna Kraszowska, Head of Investor Relations, Zealand Pharma2: Okay. Maybe just on the maybe less sneaky then, the bit that I also asked on the DAPI combination. Could that be a potential combination partner with Petrolintide?

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: I think actually DAPI is also an interesting combination partner, but it’s probably not what we would do first because you want to you can say the first combination experiences, you probably want to work with a product where you have, you can say, better understanding of the GLP-one component before you start to combine. We don’t want to use two molecules that are at that early stage. But obviously, later in the process, there could be an interesting considerations for sure.

Anna Kraszowska, Head of Investor Relations, Zealand Pharma2: Thank you.

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thank you, Bhosan.

Conference Operator: Thank you. We will take our next question. And the question comes from the line of Benjamin Jackson from Jefferies. Please go ahead. Your line is open.

Anna Kraszowska, Head of Investor Relations, Zealand Pharma2: Great. Thank you for

: the question, team. So firstly, just a very short one on the DAPI Part two data. Is the hope here to present it alongside the thirteen week data at the medical conference that is referenced this year. Is that the hope or is it too early to think about because we haven’t had the readout yet? And then the second question is more about the rationale of ZUPREME-two and the obese diabetics here.

Is the end goal to try and find a label for obese diabetics with this molecule, obviously noting the different impact on HbA1c that it has? Or is it more of an exploratory study? And alongside that, what is building confidence of the potential difference of amylin when you look at the weight loss in obese individuals versus obese diabetic individuals? I think some data has pointed to that potentially there’s a little bit more weight loss relative to GLP-1s in diabetic individuals. What builds confidence around that?

And is there anything you can point to for us for this trial? Thank you.

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thanks. I will start and then David can add. So the twenty six week data plan is probably one which we will release when we have the result meeting, so we cannot time it around the thirteen week data that is going to be presented at a scientific conference due to disclose obligation. So but it is set to read out this first half. So of course, it could be closed, but we cannot commit to that yet.

And then on SUPRIM2, it is really a study to assess, of course, the weight loss potential in obese individuals with Type II with diabetes where, as you noted, we have quite compelling data to show that where we have seen that amylin analogs looks to be as effective in from a weight loss perspective in patients with type two diabetes as non patients living without diabetes, which is not the case for Tier one. David, do you want to add a little bit more flavor to this maybe?

David Kemble, Chief Medical Officer, Zealand Pharma: Yes, happy to, Benjamin. A really good question. Petrelentide and amylin agonist, I think have two and perhaps more distinct characteristics in their putative mechanism of action. One is in contrast to GLP-1s and Inkerton’s, remember, are named Inkerton’s due to their capacity to stimulate additional insulin secretion, particularly in the post meal period, but chronic elevation of insulin remembering that insulin is an anabolic hormone. It’s a storage hormone.

So when you stimulate insulin secretion, particularly in those with diabetes who have a relatively poor glycemic control, you will take those circulating calories and store them. To your point, amylin agonists are not put forth to be as potent a glucose lowering agent given that its effects are mostly on gastric emptying and glucagon suppression as well as food intake. But in addition, there is evidence that amylin agonism with act of the pramlutide and other asset days is also insulin sensitizing. So both insulin sparing and insulin sensitizing characteristics of amylin agonists in those with diabetes would be expected to maintain the weight loss you see in the non diabetes population. Obviously, to your point, if glycemic control is substantially poorer than is desired, are these likely to be the most potent glucose lowering agent?

I think the data with cagrilentide versus semaglutide show that for glucose lowering GLP-one agonists are likely to be the most effective. But for weight loss alone, we believe amylin agonism can maintain the same degree of weight loss in the diabetes as non diabetes population, probably due to those factors I mentioned and others that will be explored.

: Thank you so much.

David Kemble, Chief Medical Officer, Zealand Pharma: Thanks, Benjamin.

Conference Operator: Thank you. We will take our next question. Your next question comes from the line of Henborg from Deutsche Bank (ETR:DBKGn). Please go ahead. Your line is open.

Anna Kraszowska, Head of Investor Relations, Zealand Pharma3: Hi. Just one question for me please. What are you hoping to show with your Phase 2b, Supreme one data in the non diabetic obese population? And what more do you think this will tell you around the clinical profile of PETRI than we already know from your data last summer? And just finally, do you think you need this data to realize full value of any sort of partnership discussions?

Thank you.

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thanks for the question. With regard to partnership discussions, it is not our, you can say, belief that further data are needed to continue these discussions. I think we have a very strong data package and good alignment on what the data shows, of course. So I would say it’s not data readout from between two and three are not related to the discussions we have. On what we expect to see from that data set, what we have set high level is that it should just continue to confirm our target profile of being able to achieve 15% to 20% weight loss in longer term Phase III studies.

So of course, ultimately, one thing is the number we will achieve after forty eight weeks, but the other one is, of course, the slow of the curve and what have you. Because in general, with weight loss medications, you expect to see continuous weight loss over time, in particular, with molecules which patients can then stay on for sure. So we are not giving a specific guidance for what we expect from that number. That will be more complicated. But as long as we are confident we can achieve fifty percent to twenty percent, then we will be very happy in longer term studies.

Anna Kraszowska, Head of Investor Relations, Zealand Pharma3: Great. Thank you.

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thank you, Anne.

Conference Operator: Thank you. We will take our next question. The question comes from the line of Thomas Franken from KBC Securities. Please go ahead. Your line is open.

Thomas Franken, Analyst, KBC Securities: I want to ask one question. Given that you view Amylin as a potential backbone therapy in obesity, what is your strategy for this target beyond battery? Do you plan to explore alternative or less frequent dosing regimens, for example, or monthly versus weekly dosing?

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thank you for your question. I think number one, we are we truly believe that once weekly dosing is a very attractive administration form for patients. But having said that, of course, we also recognize that others could some patients could potentially prefer less frequent dosing or other modalities. And we are investing at a, you can say, bench work into exploring different opportunities for also changing, making longer, you can say, formulations that allow for less frequent dosing and oral administration. But these are all life cycle management activities that will only get into the clinic in a partner framework where we would, of course, you can say, hope to continue to build the franchise out around the train sites.

But the key focus is, of course, the ones weekly dosing, getting into Phase III and obesity and then rapidly also progressing into associated comorbidities to truly build, including CV outcome studies, to truly build what we believe can be a foundational therapy. But there’s plenty of opportunity to then expand around that franchise for sure. So thanks for that question.

Conference Operator: Thank you. We will take our next question. And the question comes from the line of Kerry Halford from Berenberg. Please go ahead. Your line is open.

Anna Kraszowska, Head of Investor Relations, Zealand Pharma4: Thank you very much. A couple of questions left to me, please. With regard to the Phase III preparation investment that you have, does that relate to both petroleum and type and DAP you tied? And I wonder if you can just talk about exactly what you are looking to entail here. And in the context of thinking about Phase three, is there any scenario under which you would consider pursuing that next stage of development on your own for both or one of those two products?

Then with regard to the Phase 2b program for PetrolInsight, I wanted to check, are you measuring body composition, quality of weight loss in both, between one and two? I can see on your slide that you’ve been one, but also second study. And then essentially, you talked at great length about the differentiation potential for petrolymphoid intolerance tolerability. So I just love to hear your expectations of whether the body composition angle could be a key point of differentiation for this drug also. Thank you.

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thank you. I’ll start and then hand over to David again. So the investments that you are looking at this year is, of course, number one, we have three large Phase IIb studies that are going on, but we are also going all in and investing in all the activities needed to progress as shift as possible into Phase III for both programs. And it is, of course, additional smaller clean farm studies. It’s manufacturing of drug products.

It’s actually scaling up, you can say, to make sure we have the right batch sizes that can also be continued into commercial scale. It’s device development to make sure we have the right device options when we move into Phase III. It’s all those things that we typically don’t talk too much about, but incredibly important to move in with confidence into Phase III, especially when you’re addressing a large disease like obesity. You need to have thought all these elements through and invested in them in good time. And that is what our investments are going into this year.

For Phase III initiation, it’s not our ambition to get into Phase III alone. But again, we are not guiding on when we will have the partnership, but we would definitely expect to move into Phase III with a partner. But that doesn’t change the fact that once you start Phase IIb, you need to start the Phase III planning big time and make these investments into devices, API, product and so on, which is what we’re doing already now. David, maybe you want to talk a little bit about the Phase II design, body composition, solubility and differentiation? Thank you.

David Kemble, Chief Medical Officer, Zealand Pharma: Happy to, Adam. And as Adam said, on the Phase three, enabling work is fully underway. The body comp, as noted in ZUPREME-one will be a component of the outcomes as we are doing this by MR measurements MRI. This is dedicated sub study because you need the technology and the centers that can execute the MR measurements. A bit more specific to lean mass, meaning muscle mass versus fat mass than is DXA.

At present, the opportunity to measure body comp in ZAPREME-two is also present. The mechanism by which we’ll do that remains under discussion. But we believe should body composition measurements in Zabream one demonstrate that preservation of lean mass as has been demonstrated in animal models that doing so in a more generalized fashion, for example, using DXA is possible. But MR, as I said, is perhaps the more specific. You also asked the question as to whether this can or would be differentiating if I refer to the more recent FDA guidance or draft guidance on obesity programs.

The same questions exist at the agency as exist for all of us. And that is, can you preserve functional lean mass, certainly losing muscle mass and then one who is sarcopenic or losing muscle mass inherently, older adults, those who are less active, those who may have complicating conditions would be critically important. So getting functional measures at some point in Phase three, whether that be grip strength, six minute walk, other things will also in our mind be important alongside those specific measures of fat versus muscle and or lean mass. So, yes, we will continue to pursue this and at least clinically, I believe in selected circumstances, this could be a very important differentiator.

Anna Kraszowska, Head of Investor Relations, Zealand Pharma4: Thank you very much.

Conference Operator: Thank you. We will take our next question. And the question comes from the line of Laura Hindley from Morgan Stanley (NYSE:MS). Please go ahead. Your line is open.

Hi. Thanks for taking the question. So yes, following on the theme of Phase three planning, can you remind us what your current cash position would support in terms of development progress for your wholly owned obesity pipeline assets? And then back on the theme of quality of weight loss, on your slide for dapaglutide Phase 2b design, you have a body composition endpoint. Is there any evidence that you would flag to suggest that GLP2 would have a differentiated effect on quality of weight loss?

And then finally, when you’re having your negotiations for partnership around petrolyntide, is there also any discussion around dapiglutide or is it entirely focused on Amylin for now? Thank you.

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thank you for your question. I’ll start by answering the last question and then Henley Eddy will provide some favors on the cash position and maybe David you can discuss the last question. But we are very focused on Catrin side in these partnership discussions and try not to complicate it with Debbie. So that’s the simple answer to that one. And I think that’s so that will be next once we have concluded Catrin side.

Henley, do you want to discuss the Yes.

Henriette Abinneker, Chief Financial Officer, Zealand Pharma: Hey, Laura, thanks for your question. As you know, on

: the runway, we don’t really guide

Henriette Abinneker, Chief Financial Officer, Zealand Pharma: on the runway anymore. And of course, we have a step up in OpEx now in 2025 compared to previous years. But I think as you also recognize, there are a lot of moving pieces when it comes to our runway. We have a very sufficient cash position, DKK9 billion in the bank as we start the year. And of course, as we progress, we can easily fund Phase II.

And then we will, of course, also when time comes, we will see revenue streams coming in from ceradutide. And then, of course, there will be potential partnership, both on Pertuzentine, but also on RaditySet that can happen

: at run rate. So I think we are in

Henriette Abinneker, Chief Financial Officer, Zealand Pharma: a very good spot where we have the cash available to fund the activities we have at hand and also progress some of these initiation of Phase III activities that would be required early on. We actually invest heavily in that as well. So we have the cash needed for now. I think that’s it. David?

David Kemble, Chief Medical Officer, Zealand Pharma: I’m happy, Laura, to discuss your second question, the quality blood loss in DAPI. I would say we’re investigating this for two reasons. One is to understand is this similar to or distinct from other GLP-one based therapies where obviously when you profoundly food restrict the muscle mass loss can occur. There is not to my knowledge any direct effect of GLP-two on preservation of lean mass or any specific signals. This is a growth factor in some ways.

So there is at least the theoretical potential. The other point of interest is if inflammation is substantially impacted, which we believe it may be, will that change, if you will, the metabolic environment of adipose tissue? So adipose tissue in those with overweight and obesity tends to be affected by an inflammatory microenvironment. If we can diminish that microenvironment, do we at least see the capacity to mobilize fat stores? So I would not go into this hypothesizing for you that we will see a difference.

But I think important for us to understand one is it like other agents and the GLP-one based therapeutic classes, is there any other unique effect that may come from GLP-two either directly or indirectly through its effects on inflammation.

Conference Operator: Great. Thank you.

Henriette Abinneker, Chief Financial Officer, Zealand Pharma: Thank you.

Conference Operator: We will take our next question. And the question comes from the line line of Jesper Ilsso from Carnegie. Please go ahead. Your line is open.

Anna Kraszowska, Head of Investor Relations, Zealand Pharma5: Thanks so much. A question for Eric Cox. It’s a bit more broader question, but you previously worked in Carmart, which were acquired by us. So perhaps you can share your sort of view on the general deal space in the obesity market today versus back when you worked in Carmart because I think a typical question we also get is, yes, we have very good UPC assets, small and more innovation, but we haven’t yet seen the bigger deals and we are starting to see some deals happening from China for smaller early stage assets. So just interested in your view and sort of what is sort of the barriers to these bigger deals happening or holding a deck?

Thank you.

Anna Kraszowska, Head of Investor Relations, Zealand Pharma6: Sure. So thanks for the question. I think it’s difficult to predict to kind of what that future looks like, but I think we all know that in the last twelve months that we’ve seen quite a significant change in the marketplace. I think that we start to learn more about the GLP-1s and we start to see is where there’s new opportunities. And I think as Adam has already articulated, I think the we’re starting to see is that the vast majority of the patients are still seeking between 15% to 20% weight loss and they’re looking for new therapies.

So it’s hard for me to predict is where we’re going and what’s going to do a deal, but I think we know this market is constantly evolving and will continue to evolve to look for more improved medicines to get them better overall patient experience.

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thanks.

Conference Operator: Thank you. We will take our next question. Your final question comes from the line of Julian Harrison from BTIG. Please go ahead. Your line is open.

Anna Kraszowska, Head of Investor Relations, Zealand Pharma7: Hi. This is Ray on for Julian. Congrats on all the progress and thank you for taking our question. Just a couple from us on glepaglutide. First, is it abundantly clear that an additional study is necessary in The U.

S? Or is there an opportunity to potentially refile based on the existing data? And then as a follow-up to that, what could the approximate timeline for refiling the NDA for glepaglutide in The U. S. Look like?

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: Thanks. Thank you for that question. We are quite certain that we need to do EAS5. So that is definitely the plan right now. And based on the feedback we have, as David has said, we feel comfortable around, you can say, the first Phase III study and also agreeing the way on the effect and safety profile, but FDA has asked for more evidence.

So we are quite confident we have to do another Phase III study. We do not yet guide on when we expect to have data ready and thus be able to resubmit the NDA. But we plan to start the Phase III study in the second half of this year, and then we’ll provide more clarity on timelines. Thank you.

Anna Kraszowska, Head of Investor Relations, Zealand Pharma7: Got it. Thank you. Very helpful.

Conference Operator: Thank you. This concludes today’s question and answer session. I’ll now hand back to Adam Steinsberg for closing remarks.

Adam Steinspa/Steinsberg, President and Chief Executive Officer, Zealand Pharma: With that, we would like to thank you all for attending and for your questions. We look very much forward to future announcements and updates and to connecting in the coming weeks and months. Thank you.

Conference Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.