Earnings call transcript: Zealand Pharma’s Q1 2025 financial performance and strategic collaborations

Published 08/05/2025, 14:22
 Earnings call transcript: Zealand Pharma’s Q1 2025 financial performance and strategic collaborations

Zealand Pharma (ZEAL) reported its financial results for Q1 2025, highlighting a revenue of 8 million DKK, primarily driven by its Segalog license agreement with Novo Nordisk. The company anticipates a significant upfront payment of $1.4 billion from Roche in Q2 2025. The stock currently trades at $64.51, down from its previous close of $69.53. With a market capitalization of $4.5 billion, InvestingPro analysis suggests Zealand Pharma is slightly undervalued. The company is poised for growth with strategic collaborations and a robust pipeline, despite challenges in the competitive obesity treatment market.

Key Takeaways

  • Zealand Pharma reported Q1 2025 revenue of 8 million DKK.
  • A transformative collaboration with Roche is expected to bring a $1.4 billion upfront payment.
  • The company is strengthening its obesity treatment pipeline with multiple trials underway.
  • The stock price remained unchanged at 17.59 USD, reflecting stable investor sentiment.

Company Performance

Zealand Pharma’s performance in Q1 2025 was driven by its Segalog license agreement with Novo Nordisk. The company is strategically positioned in the obesity treatment market with ongoing trials for several promising candidates. Despite the competitive landscape, Zealand Pharma’s unique collaboration with Roche and its focus on innovative therapies provide a strong foundation for future growth.

Financial Highlights

  • Revenue: 8 million DKK, driven by a key licensing agreement.
  • Cash position: 8.5 billion DKK, projected to increase to approximately 18 billion DKK post-Roche deal.
  • Projected net operating expenses for 2025: 2-2.5 billion DKK.

Outlook & Guidance

Zealand Pharma is optimistic about its future, expecting the closure of the Roche deal in Q2 2025. Analysts share this optimism, with a strong buy consensus and price targets ranging from $110 to $169 per share. The company plans to hold a Capital Markets Day on December 11, 2025, to further discuss its strategic initiatives and growth prospects. It remains confident in achieving profitability without the need for additional capital raising.

Executive Commentary

CEO Adam Steensper remarked, "Zealand has never been in a stronger position than we are today financially, organizationally, and in terms of our clinical development pipeline." He expressed confidence in the potential of betralentide, stating, "We think it will create a significant new opportunity with betralentide if we can continue to provide the results we have seen thus far."

Risks and Challenges

  • Competitive Landscape: Intense competition from established players like Novo Nordisk and Lilly.
  • Regulatory Hurdles: Potential delays in clinical trial approvals and market entries.
  • Market Adoption: Challenges in increasing the adoption of obesity treatments among eligible patients.
  • Economic Factors: Macroeconomic pressures could impact funding and operational costs.

Zealand Pharma is navigating a complex market environment with strategic partnerships and a focus on innovation. The company’s financial health and collaborative efforts position it well for future success, although it must remain vigilant in addressing industry challenges. InvestingPro’s comprehensive analysis, including detailed financial health scores and exclusive research reports, provides deeper insights into Zealand Pharma’s potential and risks. Access the full analysis to make more informed investment decisions.

Full transcript - Zealand Pharma A/S ADR (ZEAL) Q1 2025:

Conference Operator: Good day, and thank you for standing by. Welcome to the Zealand Pharma Results for Q1 twenty twenty five Conference Call. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, Adam Langer, Vice President Investor Relations. Please go ahead.

Adam Langer, Vice President Investor Relations, Zealand Pharma: Thank you, operator, and thank you to everyone for joining us today to discuss Zealand Pharma’s results for the first three months of twenty twenty five. You can find the related company announcement on our website at sealantpharma.com. As described on slide two, I caution listeners that during this call, we will be making forward looking statements that are subject to risks and uncertainties. Turning to slide three and the agenda. With me today are the following members of Zealand Pharma’s management team.

Adam Steensper, President and Chief Executive Officer Henriette Abeneneke, Chief Financial Officer and David Kendall, Chief Medical 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 Stingsberg, President and CEO.

Adam Steensper, President and Chief Executive Officer, Zealand Pharma: Thank you, Adam, and thanks to everyone for joining today. Zealand has never been in a stronger position than we are today financially, organizationally, and in terms of our clinical development pipeline. Our vision is to become a key player in the future management of obesity and we now have the strongest possible foundation to realize this vision. We have a differentiated mid to late stage obesity pipeline and recently entered a historic and transformative collaboration with Roche on for betralien tide. The agreement with Roche includes co development and co commercialization rights, a fiftyfifty profit sharing in The US and Europe, and adds a new product candidate to our pipeline in the form of betrillion type CT388.

We look very much forward to embarking on this partnership with Roche aiming to establish the leading amylin franchise with patreonotype as a future foundational therapy for weight management. Both of our late stage rare disease programs have a clear path forward. We remain committed to bringing these programs to patients as quickly as possible while actively exploring partnership opportunities. During the last two years, we have significantly strengthened the organization to prepare ourselves for this unique next phase of accelerated growth. And importantly, we have secured enough capital to fund our journey towards profitability.

In the last period, we have seen geopolitical and market uncertainty. In general, I believe Zealand is in a strong position to meet these challenges as we expand our operations and invest for accelerated growth. Our strong capital situation allows us to progress towards profitability with confidence and our execution power has been significantly improved both due to the strengthening of our organization and due to the Roche partnership for Petrainside where they are responsible for setting up commercial manufacturing and supply. We believe that amylin analogs host the potential to become the future leading category for weight management. The increasing body of clinical evidence supporting the safety, tolerability, and efficacy of amylin analogs have de risked the amylin proteinocyte program as well.

In fact, there has been a short acting amylin analog on the market approved for diabetes for more than twenty years. And in December, we saw phase three data with another long acting amylin analog that appeared to have a safe and well tolerated profile further derisking the class. Thus, in petrillion sites, we are based on the clinical data reported to date and due to the molecular specific attributes confident in a best in class potential and thus a unique opportunity to build the leading amylin based franchise for weight management. Turning to slide five. We have a strong focus on building the foundation for the next phase of accelerated growth for Zealand.

Fueled by the partnership with Roche, we can now increase our efforts on several fronts, including significant new investments in the research pipeline targeting obesity and inflammation. Due to the type of partnership agreement that we have entered with Roche for betrayal side, we’re training equal strategic rights and fiftyfifty profit sharing in The U. S. And Europe, Zealand has the potential to become a very different company in just a few years. And we need to have a pipeline that reflects such a company.

In recent months, we have strengthened the organization across all layers. Steven Smith, a recognized leader in obesity and metabolism clinical research has joined us as medical advisor in obesity. Steven will be central in advancing our obesity research and clinical development programs in our pursuit of addressing one of the biggest healthcare challenges of our time. In April, we were excited to welcome Ruud Palsheng as our Chief Scientific Officer and new member of the executive team at Zealand Pharma. Woodpelt brings nearly twenty five years of industry experience spanning the full drug discovery and development lifecycle, most recently as Senior Vice President of Small Molecule Discovery at Lilly, where he spent more than eighteen years.

Utpal will lead the discovery and clinical translation of peptide medicines leveraging technologies including data science and AI to enhance our discovery process. Hence, Wootper will drive the next wave of differentiated innovative therapies at CN Pharma and will be instrumental in building the company into an enduring and generational biotech. This leads me to slide six. We are focused on developing new and better treatment options for people with overweight and obesity to tackle one of the greatest healthcare challenges of our time. We are still in the very early days of the evolution of this market.

In The US, only about two percent of eligible patients with overweight and obesity are on pharmacotherapy today. Despite the availability of once weekly GLP-one based therapies, real world treatment persistence remains a challenge, and the number of patients benefiting long term from these treatments has not yet seen a substantial improvement. There is thus a significant unmet medical need for therapies that can deliver effective weight loss, but with an improved tolerability and acceptability compared to current therapies on the market, including a lower frequency and milder severity of gastrointestinal adverse events, so that patients may have a more positive experience and can better achieve and importantly maintain a healthy weight loss. In a weight dose maintenance setting, we believe that gastrointestinal adverse events like diarrhea, constipation, and this feeling of having lost your appetite experienced by many patients on a GLP-one based therapy are just as important as the more commonly discussed nausea and vomiting. While all GLP-1s and once monthly injectable GLP-1s may help expand the overall GLP-one class, we view them more as complementary approaches rather than distinct alternatives.

With the potential for an improved gastrointestinal tolerability profile and differentiated mechanism of action that makes people feel full faster rather than suppressing their appetite, we believe that amyloid analogues can be the preferred choice for the vast majority of people with overweight and obesity, both during weight loss and importantly in the weight loss maintenance setting. And with that, let’s move to slide seven, as I turn over the call to our Chief Medical Officer, David Kendall to discuss our R and D pipeline. David?

David Kendall, Chief Medical Officer, Zealand Pharma: Thank you, Adam. Today I would like to focus my remarks on the continued advancement of our obesity programs, in particular petrolandide, following the announcement of our exciting partnership with Roche. And I will also provide a brief update on our other ongoing development and regulatory activities. Let’s move to slide eight. We now have the opportunity together with our partner Roche to establish the leading amylin based franchise for weight management and rapidly expand into obesity related comorbidities.

We remain committed to advancing patralentide as standalone therapy targeting 15 to 20% weight loss and better patient experience with improved gastrointestinal and overall tolerability and acceptability. We believe such a product profile has the potential to address the unmet medical needs for the majority of people living with overweight and obesity, thus positioning Petrelantide as a foundational therapy. We also maintain that petrelentide has the potential as a best in class therapy as this asset is both physically and chemically stable with no fibrillation at physiologic pH and petrelentide was developed so that it can be co administered and co formulated with other peptide based therapies. The broad collaboration scope with Roche allows us to explore and unlock the full potential of petrelentide and reach as many patients with overweight and obesity as possible. Together we will leverage the advantageous attributes of patrelentide and explore the candidate in combination with other agents, starting with a fixed dose combination product of patrelentide and CT388, a potential best in class GLP-one GIP receptor dual agonist and Roche’s lead incretin asset.

One novel concept that we find interesting with the petrelentide CT388 fixed dose combination product is to maximize the dose of the generally better tolerated non incretin agent petrelentide, having the optimized dose of the incretin based GLP-one GIP therapy for people who both need and desire more weight loss and or improved glycemic control without materially compromising tolerability. Together with Roche, we look forward to initiating Phase two trials with the petrelentide CT388 fixed dose combination product in early twenty twenty six and to explore other potential petrelentide based combination products as we move forward. Turning to slide nine for an update on the status of petrelantide Phase II ZUPIREME program. In December 2024, we initiated a large and comprehensive phase two trial with patralentide in people with overweight or obesity. ZUPREEME one is a dose finding trial assessing the safety and efficacy of five doses of patralandide versus placebo over forty two weeks of treatment.

We were also excited to announce the completion of enrollment for this trial in March 2025, just three months after trial initiation and we look very much forward to reporting top line results from ZUPREEME-one in the first half of twenty twenty six. In April 2025, we also announced the initiation of ZUPREEME-two Phase two trial of patralentide in persons 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 where attenuation of weight loss has been consistently observed when comparing those with diabetes to those without diabetes. We expect to complete the ZUPREEEM two trial in the first half of twenty twenty six.

The clinical development of patreliantide is progressing very well and together with Roche, we are excited to leverage insights from the ZUPREEEM program to guide the design of a comprehensive and ambitious Phase three registrational program for patralentide in weight management. Turning to slide 10 for some remarks on cervadutide and dapaglutide. Cervadutide, a dual glucagon GLP-one receptor agonist, is in late stage development for both obesity and metabolic dysfunction associated steatohepatitis or NASH. In the first quarter of twenty twenty five, Boehringer Ingelheim completed enrollment in the Phase three Synchronized Cardiovascular Outcomes Trial, marking full enrollment in all trials in the Phase three Obesity Program. We look forward to top line data from the first Phase three trial in people with overweight or obesity anticipated in the first half of twenty twenty six.

Boehringer Ingelheim expects to launch Cervadutide in 2027 or 2028 and if successful, Cervadutide could be the third incretin based therapy to market and it would be the first approved dual glucagon GLP-one receptor agonist in this exciting era of novel weight loss therapies. Cervadutide holds best in class potential for the treatment of obesity and MAH. We are very excited about the ongoing Phase three program in people with MAH, which represents the largest ever Phase three MAH program with an incretin based therapy and the only program to also include people with compensated cirrhosis. MAH is one of the most prevalent and serious obesity related comorbidities with significant unmet medical needs. It is estimated that one third of people with overweight and obesity have MAH.

With best in class MAH data presented last year from a 48 phase two trial, we believe cervadutide has the potential to become the preferred therapy in a very large and growing market, benefiting patients who urgently need more and better treatment options. Apiglucide is designed as a potent GLP-one receptor agonist targeting significant weight reduction and offers the potential to also leverage GLP-two pharmacology to improve gut barrier function and address the low grade inflammation associated with metabolic disease. We look forward to presenting the results from part one of the Phase 1b dose titration trial with dapaglutide at the American Diabetes Association’s eighty fifth Scientific Sessions in June 2025. In the second quarter of twenty twenty five, we also look forward to reporting top line results from Part two of the Phase 1b trial investigating higher doses of dapaglutide over twenty eight weeks of treatment with subsequent initiation of a phase two trial. Moving to slide 11 and a brief update on our rare disease programs.

For doziglucagon in congenital hyperinsulinism, resubmission of Part one of our original new drug application and the subsequent submission of Part two are contingent on an inspection classification upgrade of our third party manufacturer’s facility. While we await the potential classification upgrade, we are implementing a supply contingency plan in parallel, including qualification of an alternative supplier to ensure that we can bring this product to patients in need as quickly as possible. For glopaglutide, for the treatment of short bowel syndrome with intestinal failure, we successfully completed the Type A meeting with the U. S. FDA in March 2025.

We have now ensured alignment on the trial design Phase three EASE V trial, so that it can support regulatory submission in The U. S. And we remain on track to initiate EASE V in the second half of twenty twenty five and we expect to share more details on the trial design later this year. We also still anticipate submitting a marketing authorization application in the second half of twenty twenty five to support the approval of glipagazide in the EU. With that, I would now like to turn the call over to our Chief Financial Officer, Henrietta Veniquette, to review our financial results for the first quarter of twenty twenty five.

Henrietta?

Henriette Abeneneke, Chief Financial Officer, Zealand Pharma: Thanks, David, and hello, everyone. Let’s turn to slide 12 and the income statement. Revenue in the first three months of twenty twenty five was 8,000,000 DKK, mainly driven by the license and development agreement for Segalog with Novo Nordisk. Revenue from the initial upfront payment of $1,400,000,000 US dollars related to the collaboration and license agreement with Roche will be accounted for upon closing of the agreement, which we expect in the second quarter of twenty twenty five. Research and development expenses of $290,000,000 DKK are mainly driven by the development of patisiran, including the last phase two SUPRIME-one trial and preparation for the phase two SUPREME two trial, which was initiated in April 2025.

Sales and marketing expenses of 37,000,000 DKKK are mainly driven by pre commercial activities associated with our rare disease assets. General and admin expenses of 65,000,000 DKK reflect the continuous strength of organisational capabilities as we prepare the organization for the Roche partnership as well as investment in IT infrastructure and our patent portfolio. Net financial items of 70,000,000 DKK are mainly driven by interest income from the excess liquidity invested in marketable securities. Let’s move to slide 13 and the cash position. As of 03/31/2025, cash, cash equivalents and marketable securities totaled 8,500,000,000.0 DKK.

As mentioned, we expect to receive the $1,400,000,000 payment from OSH in the second quarter of twenty twenty five, equal to approximately 9,200,000,000.0 DKK. Upon closing of the transaction, this will bring our cash position to roughly 18,000,000,000 DKK. I can confidently say that we are in an extremely solid financial position. On top of this, we will receive in total $250,000,000 in anniversary payments over two years and potential development milestones of up to $1,200,000,000 with the vast majority of these development milestones linked to initiation of phase three trials with patisiran monotherapy. I’m not only confident that we can fully meet all our financial obligations under the Roche partnership for paternity, but also that our solid financial position provides ample flexibility to invest on Purtuniside, including in our early stage research pipeline targeting obesity and inflammation and to further strengthen our organisational capabilities in preparation for the growth journey ahead.

Based on our current clinical and organizational plans, we project that we have the financial strength to take Zealand Pharma all the way to profitability with no need to raise additional capital. This is truly a pivotal milestone for the company. Turning to slide 14 and the financial guidance. I will keep this short as there are no changes to the outlook for the year compared to what we outlined in February 2025. We confirm the financial guidance on net operating expenses, which we are expected to be between 2 and 2 and a half billion DKK, excluding transaction related costs associated with the Roche partnership agreement.

We expect these transaction related costs to be approximately DKK200 million in 2025. And with that, I will move to slide 15 and turn the call back to Adam for concluding remarks.

Adam Steensper, President and Chief Executive Officer, Zealand Pharma: Thank you, Henriette. The first quarter of twenty five was truly historic for C. And Pharma, but I’m even more excited about what’s to come. Some of the key catalysts over the next twelve months are highlighted on this slide. First and foremost, we look forward to initiating our collaboration with Roche once the agreement is closed, which is expected here in the second quarter.

Regarding clinical data, we’ll report additional results from the phase 1b trial with dabaglutide later this quarter. And in the first half of twenty six, I’m particularly excited about the phase two top line results with betrayal type and top line results for the phase three obesity trials with cerdulotide. Moving to slide 16. As a final note, I encourage all of you to save the date for Zealand Pharma’s Capital Markets Day on December 1125 in London. The event will feature speakers of our management team as well as thought leaders in obesity.

We will speak in more details about this day later in the year and hope to see many of you there either in person or online. Thank you all. I will now turn over the call to the operator for questions.

Conference Operator: Thank you. As a reminder to ask a question you would need to press 11 on your telephone And your first question comes from the line of Michael from Nordea. Please go ahead. Your line is open.

Michael Novod, Analyst, Nordea: Thank you very much. Michael Novod from Nordea. Two questions. One to betralentide and one to glipaglutide. So on betralentide, maybe can you try to elaborate more on at least the early discussions you’ve had with Roche when you did sort of the deal.

I know you can’t really talk together right now until the deal is closed, but the early discussions around different ratios for the amylin versus GLP-one in order to try to improve tolerability, also with focus on how the initial data looked on for CT388. And then secondly, for glipaglutide, and I know it’s already just out of the gates from one big collaboration, but maybe you can try to talk about how you try to plan for out licensing of glipaglutide. Will we see you already in the second half of this year trying to sort of close a deal on glipaglutide? Or do we have to wait until potential launch in Europe or that you are progressing further towards the market in The U. S?

Thanks.

Adam Steensper, President and Chief Executive Officer, Zealand Pharma: Thanks. Thank you, Michael. And I will hand over the first question to David, and then the second question to Eric to talk about our efforts on clever partnering. But David, will you

Adam Langer, Vice President Investor Relations, Zealand Pharma: take the first question, please?

David Kendall, Chief Medical Officer, Zealand Pharma: Happy to and Michael thanks for the question. I think while these are early days and to your point, we will only fully engage with our Roche partner on detailed discussions once the clearance period is completed. But in those discussions and in sharing some detail around the data you and others have seen from their public disclosure of the CT388 program. There is significant effect at relatively lower milligram doses with CT388. I believe the eight milligram dose performed quite well.

And of course, the very rapid titration scheme that was used in their early phase program has not given full clarity around how one can optimize tolerability of that incretin based therapy. But as we said in the prepared remarks, I think our goal, once we see phase two data from both ZUPRENE-one as well as the first of the CT388 programs, we will have a much better sense of where tolerability can be optimized and formulation can be optimized to do as I described in my remarks, maximizing petrelentide and optimizing the three eighty eight program. But to predict on a milligram basis at this point prior to phase two data being available would be premature. But given both what we know about each asset, what we’ve learned from the CAGRI SEMA program, we think we can certainly maximize the weight reducing capacity and further optimize that tolerability and acceptability profile. So more to follow, Michael.

And Eric, over to you.

Eric Cox, Chief Commercial Officer, Zealand Pharma: Thank you, David. And Michael, thanks for the question. I think with regard to GLEVA partnering, I think there’s been a lot of interest prior to even prior to the APRA announcement. So I think we’re very encouraged by the dialogue we’re having. We’ll still see that begin to progress.

I don’t think we have a clear timeline on exactly when things will be moving forward, but there is quite a bit of interest here, which I think is very encouraging as we move forward. So I think just hold tight, and we’ll we’ll better see where we where we move with this, but we are very encouraged with the conversations we’ve had, and they’ve been very productive at this point.

Michael Novod, Analyst, Nordea: Okay. Great. Thank you very much.

Conference Operator: Thank you. We will take our next question. Your next question comes from the line of Andy Hsieh from William Blair. Please go ahead. Your line is open.

Andy Hsieh, Analyst, William Blair: Great. Thanks for taking our questions. So Adam, I think you mentioned briefly in your prepared remarks about this topic, but I’m curious about the team’s take on the maintenance opportunity specifically. How do you envision designing studies to answer relevant questions? Do you plan to do this in a Phase II setting or based on available PK data it could be seamlessly incorporated in the Phase III program?

Adam Steensper, President and Chief Executive Officer, Zealand Pharma: Okay. Thanks for your question and I will start by providing some more thoughts here and maybe David will add some flavors. But in general, I think if you look into this space so far, most companies have actually focused on weight loss In order to achieve health, which is why we are here, you need to make sure that patient stays on therapy. We think what we’re seeing right now once you let the current medicines in the hands of patients and they’re in a real world setting, many patients struggle to stay on therapy. And as we mentioned before, our understanding is that it’s actually not, it’s mostly not due to the common, you can say known side effects to the GLP-1s of nausea and vomiting.

Many patients once they have achieved their weight loss and get into the weight maintenance phase, it’s actually side effects such as diarrhea, constipation, and this thing that you lose your appetite that is a problem. I think the other thing that is a problem is that if you are too aggressive with how much you push your weight loss, let’s say a very ambitious patient achieving 30% weight loss, that person may struggle to maintain such a dramatic weight loss because most people actually once they get further into life also would like to engage in social gatherings around food and you simply many patients simply feel they have to change their life too much if they have these dramatic weight losses. So, is why we are super excited about betraynitide because we think it has a more benign profile towards GI tolerability and most importantly maybe because it works on appetite, makes you feel full faster. So it will basically not reduce your appetite but just make you feel full faster. So, the other thing that the industry have failed a little bit is to explore and I think that is what your question alluded to how to dose these drugs in the maintenance phase.

And this is something that we of course anticipate that we’ll discuss further with Rose how to address that because as I said before, we think it’s actually the most important phase to focus on how we make sure that we optimize both for the weight loss, but also for weight maintenance with a drug like patreonitide. So, it’s clearly something that we expect to discuss further with Roche once we get the collaboration going. David, do you want to add some more to that?

David Kendall, Chief Medical Officer, Zealand Pharma: Yeah, just a couple of points. And thank you, Andy. Agree and aligned with Adam that I think looking at the opportunity to both design and execute what I’ll call clinically practical clinical utility studies, how will people utilize patralentide and or its combination in real life, not solely this arms race to a bigger number over a relatively short period of time. And I think we have learned quite clearly that these will not be drug withdrawal studies other than perhaps a switch from one class of agent to another, for example, coming off an incretin based therapy to an amylin based therapy, if that’s a patient’s desire or is of clinical interest. And I think in addition to what Adam has provided, there are characteristics of amylin agonists, some of which we’ve learned from pramlintide in its history.

First is that satiety signal rather than this anhedonic food aversion signal, as Adam alluded to, that is not appealing to a lot of people, meaning avoiding food, whereas having the opportunity to maintain some degree of appetite but feeling full fast is important. Remember too, there are mechanisms that we only partially understand and that’s the leptin sensitization. If you can maintain sensitivity to the signal that comes from adipose tissue, namely leptin, Will that allow you to continue to maintain a higher quality weight loss, not just a greater degree of weight loss? All of these will be parts of what I hope we can assess in these later clinical usefulness, clinical application studies.

Adam Steensper, President and Chief Executive Officer, Zealand Pharma: Thanks. Thanks, Andy. Thanks, Andy.

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

Prakhar Agwar, Analyst, Cantor Fitzgerald: Hi. Thank you for taking my questions and congrats on all the progress. I had two on SUPREME two in overweight obesity with type two diabetes. So number one, what will be the top doses tested in SUPREME two? Would be similar to SUPREME one in obesity without type two diabetes?

And second question, early data suggested weight loss benefit for Amlan in type two diabetes should track closer to obesity, but we didn’t really see that materializing with the cadresemary DEFINE two trial. So wondering if the team had any thoughts here as it relates to the amylin plus GLP-one combination and would you still expect amylin monotherapy to have similar weight loss in type two diabetes and obesity? Thank you.

Adam Steensper, President and Chief Executive Officer, Zealand Pharma: Thanks for your question and I will just provide a few notes and then hand it over to David. We are kind of limited by the top dose that we’re also exploring in the SUPREME one. So it will be the top dose, similar top dose we explore in SUPREME two. As David said at his call, we clearly believe that the amylin analogs has the potential to provide similar weight loss in patients with type two diabetes and as in patients without type two diabetes. And I think if you carefully look into the CACRESMA data and compare that to what was achieved with SEMA as a monotherapy, it was actually very significant additional weight loss that Novo observed in a type two obese population, probably close to doubling the weight loss.

So, we think that is a very strong achievement, especially because we don’t think that you can say in that molecule, you can say the amylin component has been utilized to its fullest extent. We think it’s a low dose of amylin compared to what we progressed with. So, we have a lot of confidence still in this patient group. David, any further comments?

David Kendall, Chief Medical Officer, Zealand Pharma: Yeah, I’ll just reemphasize Adam, what you said in that Prakhar is that in the kegri summer program, at least our perspective is that once again, if you can maximize the exposure to an amylin agonist and you don’t have a profound need for the potent glucose lowering component of a incretin based therapy, you can either remove or certainly minimize the exposure to the incretin based therapy. So to Adam’s point, I don’t think we saw the full potential of the amylin agonist in that program. Obviously, ZUGRIM-two is a standalone amylin agonist only where we anticipate, but the data will tell us that comparable level of weight reduction. And certainly, both data historically from the Pramlintide studies and more recently the phase two data with Cabrillantide in the type two diabetes phase two study support this hypothesis. But of course, that’s why we execute the trials and I think we will better understand both the dose response, which as Adam said, are similar doses at the top end and the capacity to maintain weight loss potential with an amylin agonist alone.

Adam Steensper, President and Chief Executive Officer, Zealand Pharma: Thank you. Thank you.

Conference Operator: Thank you. We will take our next question. Your next question comes from the line of Suzanne van Vulfuisen from Van Lanschot, Pembong. Please go ahead. Your line is open.

Hello, team. Thanks a lot for taking my question. This is Chiara Montironi on behalf of, Susanne Bavortauzen. So I was wondering for the Pedralyntide Phase IIb readout next year, what should we expect a top line release to include, and what would you consider a good result? And, yeah, I was also wondering whether these phase two studies will include measurements of body compositions or any biomarkers that may feed into the potential of amylin for better quality of fat versus lean mass loss?

Thank you.

Adam Steensper, President and Chief Executive Officer, Zealand Pharma: Thanks. ’ll just start and then hand over to David as well. So, we do include measurements of body composition using MRI. Good result. It’s actually, I would say, probably too early to comment on that one.

What we are aiming for is ultimately in phase three to have a product that demonstrates 15 to 20% weight loss. And of course, the readout here only goes up to forty eight weeks and we will continue for phase three studies for longer. So, it’s not only the number, it’s also of course the slope of the curves at that time that defines what a good outcome is. But as long as we are confident that we can achieve that profile, we would be more than happy. And then as we have also alluded to several times in this call, very important is to understand the tolerability profile, which we think will be the key driver of differentiation compared to the GLP-1s.

David, any further?

David Kendall, Chief Medical Officer, Zealand Pharma: Yeah, two comments in addition, Adam, and the first related to MR, which I think is an important measure of body comp remembering that this allows us to look specifically at fat mass, not just lean versus non lean mass. So a bit more discrimination, which I think will help us better understand what is translated from the data that have been observed in non clinical models. The second, as Adam alluded to, is not the slope of the line, but are we seeing clear separation of doses so that we can approach the regulatory authorities at end of phase two and say, we have clear designs on specific doses for Phase three execution. I think it is important to remember that given that tolerability is one of the things that we believe will allow us to differentiate patrelentide is that the titration scheme is monthly. So again, as in my response to Prakhar, this is not a race to the greatest number, but rather an understanding of can we support the tolerability and acceptability profile and still see a trajectory that as Adam alluded to takes us to the fifteen to twenty percent GLP-one monotherapy like weight loss.

So in general terms, those are the things we will be looking at at the end of phase two and with those top line results.

Conference Operator: Thank you very much.

Adam Steensper, President and Chief Executive Officer, Zealand Pharma: Thank you.

Conference Operator: Thank you. 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. So the first one is, your peer talked yesterday to still seeing an average stay time on the GLP-one of around seven months. So I appreciate some of that supply and payer driven. But where do you think or what’s your vision for where you could get to for Petri monotherapy stay time in the future, especially in the context of maintenance therapy?

And then secondly, on your comment about needing a pipeline to reflect the future company and you’re sort of saying Petri programs obviously fairly derisked And acknowledging that your GIP agonist hasn’t moved for a while, could you talk about your ambition for future R and D in this sort of cardiometabolic space beyond the current portfolio? Any targets you see particularly interesting? Any unmet needs you expect to evolve? Thank you.

Adam Steensper, President and Chief Executive Officer, Zealand Pharma: Thanks for the question. Yeah, and we agreed to the observations around the average daytime for the GLP-1s around seven months. And I think it’s really important when you discuss that seven months that you also appreciate that it’s in a therapy area where there are not many other choices. So, while you can say it may be quite similar to what we see in other chronic therapy areas, the fact is it’s not because people get on other brands or other modalities, it’s because they stop treatment, which is super negative because ultimately you only achieve health outcomes if you achieve weight loss and maintain that weight loss. So, that’s a huge task ahead for the industry to make sure we develop weight loss agents that can help people not only lose weight, but also help them maintain those weight losses.

And therefore, we of course have a much higher ambition for how long patients should stay on an amylin. And we really think it because we have been so excited about seeing now the first tools, medical tools that can help people lose weight. I think somehow in that conversation, we forgot about the patients. We forgot about we are just humans who want to live a normal life, a little bit healthier life. But many patients once they have achieved the weight loss are not ready to make the commitments of carrying the burden of diarrhea, constipation, and that thing that you have lost your appetite.

And we think it will create a significant new opportunity with betrayentide if we can continue to provide the results we have seen thus far. And of course, if you think about the market opportunity, if you can maintain patients on treatment for longer, that really is something that drives up volumes instead of having to go out and capture new patients constantly as we see right now is the case for the current launches. So, we are, you can say very positive on the opportunity to help patients stay on longer with a category like Amylin in particular with patreonotype. On the future pipeline, it’s too early for me to comment on it except that we will increase our investments big time. And then you can say December 11, that’s probably where you will get the full vision for how we think about driving these the pipeline forward.

But of course, it’s also already today obvious from our pipeline chart that we have opportunities within the chronic inflammation immunology with the KV 1.3 as an example, which is right now in phase one, which holds potential really to you can say become a pipeline within a program. So, you should expect to hear more in December, maybe also a little earlier but have the full picture at our Capital Markets Day in December. But thanks for the question.

Michael Novod, Analyst, Nordea: Thank you.

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

Hi. Thanks for taking my questions. Just two for me, please. How will you define success, in the phase two dapaglutide study that you expect to initiate during the second half of the year? And although I appreciate it’s still quite far away, could you give us some initial thoughts on the potential topics for the Capital Markets Day in December?

Thank you very much.

Adam Steensper, President and Chief Executive Officer, Zealand Pharma: Thanks. And I think we had success for us with DAPI that looks that is we are aiming for you can say a confirmation that we can achieve here the one like weight loss with this program once we have explored the full dosing potential over twenty eight weeks. And then as David also alluded to, and maybe David, you want to provide more comments, it’s really the opportunity to differentiate in how well we address inflammation, which gives us high confidence in this program because honestly speaking, we don’t think the world needs that many more GLP-1s unless they are compared to what we already have in late clinical development out there, unless they’re truly differentiated on parameters that goes beyond just weight loss. I think it’s time we move beyond that weight loss number and think about what is the true value you bring to patients with these novel opportunities. On the Capital Markets Day there’s no question that a lot of the theme will be around the obesity, how we see the market develop, how we see our product opportunities fitting into that space.

Having key opinion leaders also talking you can say around some of the dynamics in the biology and then we would share more light around where we expect the early pipeline to develop in the coming years. So it will be hopefully a very content rich day which also provides a very clear direction for our ambition in the coming years. David, do you want to provide further to the data?

David Kendall, Chief Medical Officer, Zealand Pharma: Yeah, I will add Adam to your comment. I think as is noted, there will be myriad GLP-one based therapies and that differentiation is key. So we have a number of non clinical efforts ongoing to look at the biologic plausibility of addressing neuroinflammation, hepatic inflammation, vascular inflammation, generalized inflammation. So defining success beyond the weight reducing capacity of DAPI will be finding those comorbidities disease state targets where we believe DAPI can shine or outshine other incretin based therapies. And you could say it’s threading a needle, but more importantly, is in our mind, finding those areas where either persistent or continued inflammation derives the disease process beyond weight management alone.

And we believe, as I alluded to, that could be vascular inflammation, be hepatic inflammation, could be neuro inflammation. So success will start with the weight reducing effects and then finding those specific areas where we think dapaglutide can shine most.

Adam Steensper, President and Chief Executive Officer, Zealand Pharma: Thanks a lot.

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

Adam Langer, Vice President Investor Relations, Zealand Pharma0: Hello. It’s Oliverrow on for Rajan Sharma. So two questions. Firstly, on the Amelin competitive landscape. So we’ve seen some early data from AbbVie or Gubami and there’s some upcoming data from Lilly’s elorilentide ADA.

So could you provide some perspectives on those two assets? And why is petrolintide differentiated versus those assets? And then the second question on the Roche partnership. So could you discuss potential cost share structures on R and D? Are there any caps to spend for Zealand?

Just could you give us a sense of how much you and Roche plan to spend both on the development of Petrolinside and the combination asset? Thank you very much.

Adam Steensper, President and Chief Executive Officer, Zealand Pharma: Thanks a lot for your questions. If I start with the Roche deal, we it’s a 2 fiftyfifty agreement where we would also share the cost in R and D not when it comes to investments in manufacturing or building up the supply chain. That is the responsibility of Roche. But from an R and D perspective, we will share the cost and you can as Henrietta also alluded to doing her part of the presentation, we are confident that with the cash we have at hand and the expected near term milestones, we can cover our part and on top of that increase investment significantly. We are not yet providing clear guidance for what that part will be.

But we of course have a defined clinical development program within the contract which provides opportunities to expand beyond that if we decide to do that together with Roche. But we have ample opportunity to increase investments beyond the commitments we have into the program as it stands today in the plans, including pre launch commercial activities. On the competitive landscape, you can say of course, as we have also said for a long time because amylin is such an attractive category, we should expect to see more competition in the future. We feel very confident around the best in class potential with patreonotype, which I think is also exemplified by the deal we announced recently and the consistency of the data that we have demonstrated across several clinical studies thus far. Also, you can say when we do get timelines to market, we feel very comfortable in the position that we are sitting in now in particular also with Roche as a partner.

So, we as everyone know then as you also alluded to, Lilly, they are expected to release data from their amylin only analog later this year. They have just closed another amylin program which was based on salmon, casitoni. I think that’s a category that has repeatedly been closed, at least in our how we understand the market. So, but now they are solely focused on an amylin only molecule. And we have not seen clinical data from that program whether they’re to pursue only combination therapies ultimately with tasipitide or also monotherapy, we don’t know.

The collaboration between GruPa and AbbVie that was announced recently around that amylin analog are some years behind us. And you can say so far at least our understanding inconsistent data set that we have seen. But of course, we need to see more data and ultimately you would expect more competition in this space probably together with us. I mean, I would say Novo Nordisk is of course leading the Air Force not only with Pacrozema but also with this stated ambition of taking their amylin analogue caquilinide into phase three development in the coming period. So, but in that mix where you can say NOAA is approaching phase three with Tagliontide and we look to be the next with what we believe a molecule that has best in class potential, we feel very, very confident in our, you can say, journey ahead and ultimately we would welcome more competition in this space because we truly think this is the category that can solve the topic we have discussed so much in this call about how do we help patients not only achieve a weight loss, but also weight maintenance.

And we just feel that we are extremely well positioned to lead that category with patreningiside. Also, as we discussed here, now that we have the combination with CT388, which would address specific patient segments further really building around patreotide as a franchise and as a future foundational therapy for patients with obesity and associated diseases.

Adam Langer, Vice President Investor Relations, Zealand Pharma: Awesome. Thank you.

Conference Operator: There are no further questions. I would like to hand back for closing remarks.

Adam Steensper, President and Chief Executive Officer, Zealand Pharma: With that, we would like to thank you all for attending and for your questions. We look 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.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers
© 2007-2025 - Fusion Media Limited. All Rights Reserved.