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Zealand Pharma’s recent earnings call for the second quarter of 2025 revealed significant strides in its obesity drug pipeline, financial performance, and strategic partnerships. The company reported a revenue of 9.1 billion DKK for the first half of the year, largely driven by an upfront payment from a collaboration with Roche. Currently trading at 54.38 USD, the stock sits between its 52-week range of 47.97 USD to 151.62 USD, with a market capitalization of approximately 3.9 billion USD. According to InvestingPro analysis, Zealand Pharma appears undervalued based on its Fair Value calculation.
Key Takeaways
- Zealand Pharma’s revenue was bolstered by a collaboration with Roche.
- The company is focusing on its obesity pipeline with promising drug candidates.
- Cash reserves increased significantly, supporting future R&D efforts.
- New leadership appointments aim to strengthen scientific and development capabilities.
Company Performance
Zealand Pharma’s performance in the first half of 2025 was marked by strong revenue growth, attributed to strategic partnerships and a focus on innovative drug development. The company’s cash position improved from 9 billion DKK at the start of the year to 16.6 billion DKK, providing a robust foundation for ongoing research and development. InvestingPro data reveals an impressive current ratio of 25.1x and a strong Altman Z-Score of 16.8, indicating excellent financial stability. The company maintains a conservative debt profile with a debt-to-equity ratio of just 0.05.
Financial Highlights
- Revenue: 9.1 billion DKK, driven by Roche collaboration
- Cash position: Increased to 16.6 billion DKK
- Operating expenses: 968 million DKK, with 78% allocated to R&D
Outlook & Guidance
Zealand Pharma anticipates significant milestones in the coming years, with phase two data for patreotide expected by the end of 2025 and phase three trials planned for 2026. The company provided financial guidance of 2-2.5 billion DKK in net operating expenses, reflecting continued investment in its drug pipeline. InvestingPro analysts maintain a strong buy consensus, with price targets ranging from 62.69 USD to 175.52 USD. Revenue is forecast to grow by 148% in fiscal year 2025, suggesting significant upside potential. For deeper insights into Zealand Pharma’s growth prospects and detailed financial analysis, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
Executive Commentary
CEO Adam Stingsberg emphasized the company’s strategic shift, stating, "We are entering a pivotal new chapter." Chief Medical Officer David Kendall highlighted the potential of amylin-based therapies, saying, "Amylin is emerging as the next major class of potential therapies for weight management."
Risks and Challenges
- Supply chain issues could impact drug development timelines.
- Market saturation in obesity treatments poses competitive challenges.
- Macroeconomic pressures may affect funding and investment capabilities.
Q&A
During the earnings call, analysts inquired about the company’s manufacturing infrastructure with Roche and explored the market potential for patients intolerant to GLP-1 therapies. Executives also detailed the scientific rationale behind their amylin-based approach, which could offer improved patient outcomes.
Zealand Pharma’s focus on innovative treatments and strategic partnerships positions it well in the competitive obesity market, with promising developments on the horizon.
Full transcript - Zealand Pharma A/S ADR (ZEAL) Q2 2025:
Conference Operator: Good day, and thank you for standing by. Welcome to the Zealand Pharma Interim Report Half Year twenty twenty five 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. To ask a question during the session, you will need to press 11 on your telephone.
You will then hear an automated message advising your hand is raised. 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 six months of twenty twenty five. You can find the related company announcement on our website at zenopharma.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 today’s agenda. With me today are the following members of Zealand Pharma’s management team: Adam Stingsberg, President and Chief Executive Officer Henriette Wetteneke, Chief Financial Officer and David Kendall, Chief Medical Officer.
All speakers will be available for the subsequent Q and A session. Moving to slide four, I will now turn the call over to Adam Stingsberg, President and CEO.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you, Adam, and welcome, everyone. Today, we stand in a unique position to realize our vision to become a key player in the management of obesity. We have a clearly differentiated mid- late stage obesity pipeline with two leading programs, patriline type and cerdulutide, backed by strong partners in Ross and Boehner Ingelheim. Both programs are rapidly approaching key clinical readouts with phase two data for patreotide and phase three data for servulotype in our sites. Over the past two years, we have strengthened our organization and our internal capabilities, including recent appointments to our leadership team.
Utpal Singh, as Chief Scientific Officer, will drive the next wave of innovation, and Steven Johnson, as Chief Development Officer, will lead our development and regulatory strategies. Finally, our robust financial position ensures the strongest possible foundation as we approach major upcoming catalysts for our leading obesity programs. With this momentum, Zealand Pharma is entering a pivotal new chapter, and I’m truly excited what lies ahead. Turning to slide five. The RUS alliance for petriniatide has begun exceptionally well.
With RUS, we are rapidly advancing the petriniatide monotherapy program once the twenty eight week data from the SUPREME-one Phase II trial are in hand, which is expected by the end of this year, the undiagnosed teams can move forward with the end of Phase II meeting with the US FDA. We expect to report the forty two week data in the 2026, and initiate the phase three program with patrinetide monotherapy in the 2026. Meanwhile, we expect to initiate phase two for the first betrinetide based combination product under the collaboration betrinetide combined with Roche’s leading inguatine acid CT388, a potential best in class GLP-one TIP receptor dual agonist in the 2026. So it’s full steam ahead with the Roche collaboration on the patreno site clinical development program. Under the collaboration, Russ is responsible for all investments into commercial manufacturing and supply for patreonotype and the patreonotype based fixed dose combination.
With regards to manufacturing readiness, we are truly impressed with the decisiveness and firmness with which us moves forward. The early commitments and planning around manufacturing were a big reason why we chose them as our partner. They already building out capacity at scale, including a state of the art, high volume, high throughput fillfinish manufacturing facility in The US. These early and meaningful investments will significantly contribute to unlocking the full value potential of patreotide and our shared ambition to establish the leading amylin based franchise. At the Ross Pharma Day on September 22, we expect that they will provide further insight into their obesity strategy.
And at our Capital Markets Day in December, where our obesity strategy will take center stage, we look forward to sharing updates on the programs and on our efforts to become a key player in the management of obesity. Let’s move to slide six. It is without a doubt that new and better treatment options are needed to tackle one of the greatest healthcare challenges of our time. And with only a small fraction of eligible patients receiving pharmacotherapy today, we are clearly at the very early stage in the evolution of this market, which will require many therapeutic options with a range of different mechanisms to adequately address this chronic disease. Real world treatment persistence with the GLP-one based therapies remains a challenge, highlighting a clear need for more tolerable, simple, and patient friendly options.
As an industry, we have to move away from focusing on speed and magnitude of weight loss. This is not consistent with what the vast majority of people with overweight and obesity desire. We believe that a product with the best potential to become the preferred therapy for a broad population with overweight and obesity should deliver weight loss in the range of 10% to 20%, with the vast majority desire through a mechanism that offers a more positive patient experience with improved tolerability, including fewer and milder gastrointestinal events, so that patients can better achieve and importantly maintain a healthy reduction in their body weight. This is why we are so excited about the potential for betrinetide to become a foundational therapy for weight management. 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 leading programs in obesity and obesity related comorbidities. Let’s move to slide eight. Together with our partner Roche, we are exceedingly well positioned to establish the leading amylin based franchise for weight management and rapidly expand into obesity related comorbidities. As Adam just mentioned, petrelentide holds the potential as an effective and well tolerated stand alone therapy to address the needs of the majority of people overweight and obesity.
The broad scope of the collaboration set forth in New Zealand Pharma Roche Alliance enables us to fully explore and unlock the potential of petrolantide. The first combination product under the alliance will target the segment of people who need and desire greater weight loss and or improved glycemic control while still leveraging the better tolerability of higher dose of trelentide and adding optimized dose doses of the incretin based therapy CT three eighty eight. Turning to slide nine. In recent months, research and development activity in amylin based treatments for weight management has increased significantly. Two years ago, we faced some skepticism about our approach to amylin as an effective and appealing stand alone therapy and as an important alternative to g o p one based therapies.
Today, however, amylin is emerging as the next major class of potential therapies for weight management. In June, we saw the first detailed phase three data for a long acting amylin analog, cabrillantide. The long term data showed no unexpected safety signals and a gastrointestinal tolerability profile that demonstrated considerably fewer and less severe GI adverse events than observed with GLP one based therapies. These data represent a major derisking event for the petrelentide program as patrilentide shares both a very similar receptor profile and a structure based on the human amylin backbone like cadreflinide. That said, there are several key molecule specific differences that potentially make petrelentide superior, which are worth reiterating.
These differences include petrelentide’s chemical and physical stability, particularly around a neutral pH, the ability to administer higher milligram doses, a longer half life, and greater bioavailability.
Adam Langer, Vice President, Investor Relations, Zealand Pharma: We have also
David Kendall, Chief Medical Officer, Zealand Pharma: seen additional early stage data from other amylin based programs, including analogs derived from different backbones such as semincalcitonin or analogs with different receptor binding and activation profiles. While these analogs contribute analogs contribute to the growing body of data available for amylin based therapies, we remain highly confident in petrelentide’s consistent clinical response, the very favorable tolerability and safety profile, and the peptide construct itself underscoring petrelentide’s unique value proposition and potential to become the leading amylin based treatment and the foundational therapy for weight management. Our confidence is grounded in the totality of data we’ve generated to date. Patralentide has demonstrated the potential to deliver the weight loss that the vast majority of people with overweight and obesity desire even in studies that were conducted in a predominantly male population with a relatively lower baseline BMI, both factors that likely muted the overall weight reduction observed. To support this, we were pleased to present, on slide 10, the additional data on individual responses of participants in our sixteen week phase one b trial with petrolantide at this year’s ADA eighty fifth scientific sessions held in June.
Of note, every individual participant treated with patralentide in this trial lost weight during the study. Importantly, while only 21 of the trial participants were female, a greater treatment response was observed in females across all three petrontide dose groups.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: This leads
David Kendall, Chief Medical Officer, Zealand Pharma: me to slide 11 for a brief status update on the patralentide phase two ZUPRENE program. We have previously shared the trial designs for ZUPRENE one and ZUPRENE two, so I’ll not go into further detail here. Back in March, we we announced the completion of enrollment of more than 480 participants in ZUPIREME one. And today, we are sharing the preliminary baseline characteristics of the participants in this trial. Supreme one has a population with a mean BMI of approximately thirty seven kilograms per meter squared at baseline and includes a balanced gender distribution with fifty three percent of the participants being female, notably different than the population studied in our phase one trials.
And we look forward to reporting top line results from SUPREME one in the 2026. Turning now to slide 12 for a brief update on dapaglutide, our first in class GLP-one, GLP-two receptor ducal agonist. We were very encouraged by the top line results from part two of the phase 1b trial with higher dose dapaglutide announced in June. These data showed a weight loss that is highly competitive compared to the currently available GLP-one based therapies for weight management at similar time points despite dapaglutide being studied in a predominantly male population again with a relatively lower baseline BMI. That said, we recognize that differentiation is absolutely essential, and our strategy is to leverage the dual mechanism of dapaglutide, which includes GLP two activity, and move into a dedicated phase two obesity related comorbidity trial in the 2025.
Now turning to slide 13 in cervotatide, a potential best in class glucagon GLP one receptor dual agonist in late stage development for the treatment of obesity in NASH. We are rapidly approaching top line data from synchronized one and synchronized two phase three trials, which are evaluating the efficacy of safety and safety of cervotetide in people with overweight or obesity both with and without type two diabetes, respectively. The design of the synchronized phase three program builds on key learnings from the phase two obesity trial where trial participants achieved mean weight loss of up to 18.7% after forty six weeks. Notably, these phase three trials will assess even higher maximum doses of up to six milligrams. We remain extremely excited about the potential of cervonitide in novel dual agonist therapy for weight management and look forward to top line results from SYNCHRONZE one and two likely to be reported in the 2026.
We’re also very excited on slide 14 about the ongoing cerdotetide phase three program in people with metabolic dysfunction associated steatohepatitis or NASH, a serious obesity related comorbidity with significant unmet medical need. Shown on this slide is an indirect cross trial assessment of clinical trials with incretin based therapies in NASH compared with the only approved therapy today, thyroid hormone receptor beta agonist. In the phase two trial with cerdulatinib in people with NASH and liver fibrosis, thirty eight point six percent of adults with moderate to advanced scarring achieved placebo adjusted, biopsy confirmed improvement in fibrosis without worsening of NASH after forty eight weeks of treatment. We believe this represents the most compelling and strongest clinical data set to date on the important endpoint of liver fibrosis improvement. The leverage program initiated in 2024 is the largest ever phase three NASH program with an incretin based therapy and the only program to also include patients with compensated cirrhosis.
With the best in class NASH phase two data and the robust ambitious phase three program underway, we believe cervotetide has the potential to become the therapy of choice in a large and growing market, offering a much needed treatment option for people living with
Conference Operator: Excuse me, mister Kendall. Apologies for interrupting you. Unfortunately, your sound is breaking up and dipping in and out, so we’re finding it difficult to hear you.
Adam Langer, Vice President, Investor Relations, Zealand Pharma: Can can you try to say something, David, again?
David Kendall, Chief Medical Officer, Zealand Pharma: Yes. Can you hear me now, operator?
Conference Operator: I I can hear you now. Yes.
David Kendall, Chief Medical Officer, Zealand Pharma: Okay. Don’t know the problem, but thank you, and I’ll continue.
Conference Operator: Thank you.
David Kendall, Chief Medical Officer, Zealand Pharma: Turning now to slide 15, and apologies for the difficulties with the sound. Cervotetide is licensed to Boehringer Ingelheim as mentioned by Adam, and BI is a family owned leading biopharmaceutical company with a strong legacy in cardiovascular, renal, and metabolic diseases and a global presence across a 130 markets. Boehringer Ingelheim holds sole responsibility for the global development and commercialization of cervotatide. Zealand Pharma has no financial obligations to either development or commercialization under this agreement, but is entitled to percentage royalties on global sales ranging from high single digit to low double digit. In addition, we are eligible for up to €350,000,000 in remaining outstanding milestone payments.
Notably, Boehringer Ingelheim is an established leader in the CVRM and diabetes space having developed and launched the leading SGLT two inhibitor empagliflozin. The company has been instrumental in demonstrating empagliflozin’s benefits in reducing cardiovascular risk, slowing the progression of chronic kidney disease and alleviating the burden of heart failure. Moving to slide 16 for a brief update on our rare disease programs. For doxiglucagon and congenital hyperinsulinism, our third party manufacturing facility has not yet received a classification upgrade. In the meantime, we have implemented a supply contingency plan that includes the qualification of an alternative to supplier to ensure 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, the phase three EASE five trial remains on track for initiation in the 2025 to further support regulatory submission in The US. In June, we were pleased to announce the submission of a marketing authorization application to the European Medicines Association seeking approval of glipaglutide in The EU. We remain incredibly excited and encouraged by the clinical profile of glipaglutide as a potential best in class long acting treatment for the management of short bowel syndrome with intestinal failure. With that, thank you very much for your attention. I would like to now turn the call over to our chief financial officer, Henrietta Venenke, to review our financial results for the 2025.
Henrietta?
Henriette Wetteneke, Chief Financial Officer, Zealand Pharma: Thanks, David, and hello, everyone. Let’s turn to slide 17 on the income statement. Revenue in the first six months of twenty twenty five was 9,100,000,000.0 DKK, driven by the initial upfront payment under the collaboration and license agreement with Roche. Of the 9,200,000,000.0 DKKk in upfront payment received in June, DKK 9,000,000,000 was recognized as revenue in connection with the closing of the agreement in May 2025. The remaining $262,000,000 DKK of the initial upfront payment is associated with progression and completion of the phase two trials with patisiran, of which 167,000,000 DKKk was deferred as of 06/30/2025.
Net operating expenses totaled $968,000,000 DKKk for the 2025, of which 78% was spent on research and development. The R and D expenses are mainly driven by the development of patisiran, including the last phase two trials and preparation for phase three. R and D expenses also reflect preparation for phase two with dabaglutide, increased investments in the k v one point three ion channel blocker, as well as development and regulatory activities related to the rare disease programs. Net financial items amounted to negative 157,000,000 DKK. This is driven by exchange rate adjustments, which primarily relate to USD deposits and currency revaluations on account receivables and cash equivalents.
This was partly offset by interest income from the investment in Michaelhold Securities. Let’s move to Slide 18 and the cash position. As of 06/30/2025, our cash position totaled DKK16.6 billion, a significant increase compared to the DKK9 billion at the beginning of the year. This is, of course, driven by the initial upfront payment of DKK 9,200,000,000.0 from Roche, partly offset by operating expenses for the period and the purchase of treasury shares to support Siemens Pharma’s long term incentive programs. I would like to use the opportunity to remind everyone that on top of this very solid financial position, we are entitled to receive a total of $250,000,000 anniversary payments over the next two years under the Roche collaboration as well as potential development milestone of up to $1,200,000,000 The vast majority of these development milestones are tied to the initiation of Phase III trials with patisiran and monotherapy.
As I stated on our last quarterly earnings call, I’m pleased with our strong financial position. We can fully honor our obligation under the comprehensive HOSH collaboration for patisiran time and, at the same time, accelerate investments in the early stage pipeline to build the next wave of innovation. Let’s turn to Slide 19 and the financial guidance. I will keep this short as there are no changes to the outlook for the year. We confirm the financial guidance on net operating expenses, which are expected to be between DKK2 billion and DKK2.5 billion, excluding transaction related costs associated with the Roche agreement.
And with that, I will move to Slide 20 and turn the call back to Adam for concluding remarks.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you, Henriette. Two years ago, at our obesity R and D event in London, we laid out a bold vision to become a key player in the management of obesity through innovations that address one of the greatest healthcare challenges of our time. Today, I can say with confidence that we are exactly where we want to be towards realizing that vision. We have the sabertatide phase three obesity data and patreonitide phase two data in our sites. And we have significantly strengthened our capabilities to execute and our financial position to both advance our clinical portfolio and invest in the next wave of innovation.
So please save the date for our Capital Markets Day on December 11, where we will share further insights and updates and discuss why we are so excited about the prospects for Zealand Pharma. I will now turn over the call to the operator, and we will be happy to address questions.
Conference Operator: Thank you. Session. We will take our first question. And the question comes from the line of Rajan Sharma from Goldman Sachs. Please go ahead.
Your line is open.
Rajan Sharma, Analyst, Goldman Sachs: Hi. Thanks for taking my questions. I’ve got a couple on petrolintide. So firstly, Adam, David, it would be good to get your perspectives on the LoRa lintaide data that we saw at ADA in June. Just be interested in your thoughts on petrolintide compares and any learnings on what this means for the ongoing debate between ambulant selectivity versus DACRA?
And then secondly, just on body composition, which I know is a secondary endpoint in ZUPREME-one, but at ADA, again, we saw that data from Novo’s REDEFINE trial suggests that there was no benefit on body composition from the amylin component of of kagrisemma relative to the GLP-one. So just wondering if there’s any reason why petrolintide may be different, or should we expect any benefit here to be sort of an upside, to your base case assumption? Thank you.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you, Rajan. Maybe, David, you would take a first go on answering these questions. Can you hear us, David?
David Kendall, Chief Medical Officer, Zealand Pharma: Happy to. I’m on mute and hopefully clear on the microphone. Rajan, thanks for your question. I’m happy to provide perspective. I think the AULORA data, which are obviously early phase data in a relatively small population, as we alluded to in the prepared remarks, show us that one of the other key players in the space, Eli Lilly, has a great interest in amylin based therapies.
I think there was some excitement over the both the dosing regimen and the clinical response. I would say from our perspective, two very important key points. One, you alluded to data that colleagues from Novo Nordisk reported in a separate session, separate from the Allora poster presentation, suggested that Allora, like other balanced hemline agonist, does result in an acute lowering of serum serum calcium in animal models, which suggests that, Laura, despite what is reported and what has been in some hands, an amylin specific receptor profile, is very likely a more balanced or pan receptor activator across the calcitonin, amylin one and amylin three receptors. That said, the clinical response in our mind, particularly at the two, I’ll call them middle to high doses, is quite consistent with other drugs in this class, despite the exuberant response in their highest dose group, and the dosing interval. I I think, given the small dataset, there are also a lot of unknowns about this asset, in particular, the reports of, several neuropsychiatric adverse events, which is, distinctly different than, what has been reported both with cabrillantide and, with petrelantide, as well as headache, which has been reported with other amylin agonists and indeed with pramlentide back in the day.
Provocative tests to initiate or trigger headache were enhanced with another amylin agonist, amylin receptor agonist. So I’d say, you know, certainly encouraged that there is attention to this space. We do not see these data as clearly differentiating from other amylin based therapies including patralentide. And as I alluded to, we are quite pleased with the consistent and now comprehensive data sets we have pulled together from all the phase one trials. And, obviously, phase two will tell us much more about that treatment response.
To your question about body composition, Adam, I’m happy to turn it back to you or make comments myself.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Please comment, David.
David Kendall, Chief Medical Officer, Zealand Pharma: Yeah. I think the Novo data in a relatively small subset using a less precise, but a broader, and more applicable approach, which is DEXA, did not provide clear evidence of, changes or preservation of muscle mass. However, as you well know, Rajon, that there is, now broad evidence from nonclinical models, and I emphasize nonclinical models that amylin agonists are associated with significant preservation of lean mass, particularly in these high fat fed animals who are gaining weight. Now that is very different than older adults or those in clinical trials who are usually at a high weight but stable, who then enroll in clinical trials. But we still remain quite confident that amylin based therapies, including petrelentide, particularly using the MR based measurements we are using in the subset of patients in SUPRIME-one, can and will be the both the approach, and the studies that will demonstrate, as clearly as possible what happens to lean mass.
Importantly, while lean mass preservation to us is important, there’s really a value add on top of what Adam and I alluded to, and that’s a significant weight loss, particularly in the range of ten to twenty percent. The vast majority of patients desire and the tolerability profile Effects on other biomarkers, effects on lean mass, we think are significant value adds, but not key to the success of these molecules.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you.
Rajan Sharma, Analyst, Goldman Sachs: Thank you.
Conference Operator: Thank you. We will take our next question. Your next question comes from the line of Kirsty Rostewat from BNP Paribas. Please go ahead. Your line is open.
Kirsty Rostewat, Analyst, BNP Paribas: Hi there. Yes, this is Kirsty Rostewart from BNP Paribas. So two questions for me. Firstly, on the kind of safety and tolerability profile, you’ve of sapotralentide, you’ve kind of spoken about the target weight loss between 1520% annually before. But I was wondering if you could give some more color on what you believe would be clinically meaningful in terms of side effect profile.
And I noticed your slide indicating that kind of over half of patients are not willing to accept any GIAE. So in light of that, kind of what do you believe would represent a sufficient improvement to over GLP-1s to induce a kind of meaningful uptake in intolerant patients? And maybe one also on dapaglutide, and any read across that you see from the upcoming EVOQUE data from Novo. Maybe you could talk to the potential for dapaglutide to address diseases such as Alzheimer’s where microglial information plays a role and what you’d like to see maybe in your own exploratory data or Novo’s upcoming data to give you the confidence to go here beyond the program that you’re starting later this year?
Speaker 7: That would be great. Thank you.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you, Chris. Maybe I’ll start and then see if David has additional insights to add. On the ratio between efficacy and safety and tolerability, I think it is, as we also alluded to in the prepared remarks, a super important question. Because if you look out today, most patients actually have the tools available that can provide them with the weight loss they’re looking for. The problem is most patients don’t ever get to the highest doses, and we think a large part of those are because of side effects.
And the other thing that if you do market research, you will learn is that if you ask individual patients, they would overall, most of these patients would come back and tell you that they are looking for a 10% to 20% weight loss. But it’s also clear that the biggest challenge is to not actually achieve the weight loss today but actually maintain that. If you don’t stay on therapy, then most patients will regain the weight. So when we talk about a tolerable profile, and how we are designing our program with betrinitide, is actually with that in mind to make sure we target not only the maximum weight loss but the optimal ratio between weight loss and side effects. And what we have seen from our program thus far, as David also alluded to, is a very robust set of data suggesting that ultimately with the dosing that we are pursuing, we would expect to get into a mean weight loss of between 15% and 20%.
And if you look into the GI, in particular, side effects, but also other side effects, we have seen minimum to no GI side effects in these cohorts when dosed at the levels and with the titration regimes we use. And it is actually important to note also, as we saw from the coagulantide phase three data, that is, of course, not just about nausea or vomiting or other GI effects. It’s also the severity of these. Are they mild, moderate, or severe? And we at least saw with interest that even the caquilin type at the doses where they delivered just around 12% weight loss, it was almost entirely mild event, which was in contrast to what you see with GLP-one based therapies.
So it’s not only the event rate, but also the severity of these side effects that we think we can reduce significantly with our approach to amylin. And then on dapaglutide, and of course, I think the EVOQUE study will be super important. Remember, it’s rather low doses of ATLAS1 that is applied into that study. But we have also recognized that the profile of a DRD1 and a DRD2 could be interesting in a disease like Alzheimer. It could also be interesting in a more GI driven inflammatory condition such as IBD.
David, do you want to add further insights?
David Kendall, Chief Medical Officer, Zealand Pharma: Yeah, just one thing to add, and Christy thanks to Adam’s comment about, you know, we clearly believe with amylin agonist, less common, less severe, but I would also add that different character of those GI side effects. And while that’s difficult to tease out in clinical trials in the clinic and in particular experience back with pramlintide, This sense of fullness, satiety, that sense of feeling full more quickly, feeling full faster, is very different than the food aversion signal and the nausea. We think similarly, we’ll have a a different character to Adam’s point in our phase one program to date, only a single patient who discontinued treatment with petrolantide out of all those exposed. And in particular, when we started at lower doses in the multiple ascending dose and titrated up in a scheme even though it was every other week, that tolerability profile demonstrated, I’ll say, substantially fewer events and less severe and what we believe will be different characters or characteristics of that adverse event profile. The other comment I would make is what I emphasize, which is a distinct difference between tolerability, particularly in a clinical trial, which is designed to keep people on therapy.
Yes. If the only therapy available to me is an incretin based therapies, I may tolerate it. But when options become available, is it the most acceptable therapy? So, we will, obviously, strive to look more carefully at not just tolerability, the reported effects, but how acceptable is this to those who take an amylin based therapy versus any experience with an incretin based therapy.
Kirsty Rostewat, Analyst, BNP Paribas: Thank you.
Conference Operator: Thank you. We will take our next question. The next question comes from the line of Michael Novod from Nordea. Please go ahead. Your line is open.
Michael Novod, Analyst, Nordea: Thank you very much. Michael from Nordea. A couple of questions. So first, maybe can you discuss sort of around the commitment priorities, etcetera, with Roche? Obviously, we’ve seen a lot of movement in the obesity market, also a lot of movement to obesity market sizing forecasts over time.
So has there been sort of any big discussions in the collaboration? And has that also changed sort of what the bar is in terms of what an amylin can do in terms of monotherapy weight loss when we look into the Phase II readout in the 2026 for betralintide? And then secondly, maybe you can just try to discuss the sort of potential licensing or partnering strategy around dapaglutide. Will the Phase II that you’re doing with regards to comorbidities, would that lead to sort of conclusive results in order to start potential partnering discussions? So how should we sort of evaluate the road ahead for dapaglutide following the Phase IIb?
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you, Michael. And I will take a shot on these answers these questions. So, if you think about the developments in the obesity market right now, we have been saying for quite some time that we think people are too focused on who gets the highest weight loss and who can deliver it the fastest because market research with patients would actually suggest the opposite. Most patients are looking for 10% to 20% weight loss. And actually, some patients struggle.
If it’s too fast, they want a visible weight loss. They want to see that something happens, but it can also be too fast. So I think that is the market condition we are looking at. That is what I would describe as GLP-one launch fatigue and actually not obesity fatigue. And for, you can say, companies who have set out on a mission to address what we consider the biggest healthcare challenge of our time, For us, and I would include us in that kind of statement, that is an opportunity what we are looking into at the moment.
That is basically identifying the shortcomings of the current medicines out there and suggesting where we can actually play. We can be out there with a medicine that delivers the weight loss that are quite similar to what the products are doing today, but hopefully with a more tolerable profile and thus allow more patients to stay on therapy. A key part for why we chose to partner with us was that they already, a few years ago, took a big step into this space, and they have had a very strong commitment to wanting to get into this space and lead. So this we wanted somebody who has the same ambition as us, somebody who don’t just want to get in because it was the talk of the town but a company who really means it. And this is what we tried to allude to during the prepared remarks that we are extremely impressed to see the firmness with which they move forward.
We were, of course, extremely pleased to see also the investments into manufacturing capacity. I think sometimes it’s overlooked that it’s not just about a clinical dataset and then a decision to move forward because once you decide to move forward, if you want to be launch ready, you need to make very substantial investments into manufacturing. Otherwise, you will face the issues that the two front runners faced with supply constraints and what follows there. So our sense in our dialogue with Roche is that they are as committed, if not even more, as they have been for a long time to come into this market and become a leading company to address what we both companies see as the biggest health care challenge of our time. And if anything, I would say the bar for success is being lower in my mind these days because more and more people realize that it’s very few patients that are going for that 25% plus weight loss.
And realistically, those patients who need the highest weight loss are more likely to benefit for combination therapies rather than single modalities. That is how you treat chronic diseases. That is by combining different modalities if you need more effect than what one modality can do. You very seldom see people maxing out on one modality because often you will see side effects and safety concerns following pushing things too much. It’s much better to combine.
So, I think we are just being confirmed in these months and years on the strategy, and I think us feels the same. On the dapaglutide phase two program, I think it’s a very fair observation that our focus right now is to get the phase two study started to clearly identify the differentiation potential for dabaglutide in addressing inflammation to a larger extent than the other GLP-1s. And then our hope, of course, will be that following those data, we will go out and discuss with potential partners on that program. But we also recognize that we need those data in hand before we will have sufficient clinical excitement to progress partnership discussions on that.
Michael Novod, Analyst, Nordea: Okay. Great. Thank you.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you.
Conference Operator: Thank you. We will go to 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. Thanks for taking our questions. Appreciate the additional color about the supreme one baseline characteristics potentially hinting at a better outcome than what we’ve seen before. Two questions for two questions for us.
One has to do with Roche’s manufacturing infrastructure that you announced in the press release and the synergy that can be derived from that that project. I’m curious if both pipretatide and three eight eight are produced in with with the same means, I e, synthetic or or recombinant. So I’m just curious if you could comment on that. The second one has to do with the titration strategy when it comes to the phase two combo study that is expected to start later this year with paternitide and CT three eight eight. Are are you thinking about something that could be a little bit different from what we’ve seen in REDEFINE one and two, you know, with the in sync titration or maybe staggered titration, basically titration one titrating one followed by the other the following week.
Just curious about how you think about this titration strategy that could optimize tolerability profile. Thank you.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you, Andy. I will answer your first question and hand over to David. When we announced the manufacturing capacity expansions that have been announced in North Carolina by us is a high capacity, high volume fillfinish capacity. So that is drug product and filling lines. And it’s actually the critical path of getting products to patients that to have the filling capacity up running for prefilled pens.
It is where we have seen supply constraints historically, and it’s probably where we need the biggest investments. When it comes to API or synthesis of the program, it’s actually easier to handle and it can be handled with suppliers and and infrastructure that are more or less I mean, that that will we will need investments there as well. But it’s actually that fill finish and drug product filling lines that are causing shortage. It’s also where you can probably gain the biggest benefits by making sure you have high volume lines because it is the most costly part of your food product. On the synthesis part, we have, you can say, all things in place to support the amount of drug substance needed for launch.
Those plans were actually already being built by us before we entered the partnership. David?
David Kendall, Chief Medical Officer, Zealand Pharma: Yep. Thank you, Adam and Andy. Thanks for the question. I think you already alluded to what for us is an opportunity to do things significantly differently than was executed in the redefined program where, as you know, both both assets, the KEGRI and SEMA, doses were, essentially tied together, meaning, you escalated one, you escalated the other. Similarly, you know, the goal in that program, while the studies were complex, was to push to higher doses and also to push to greater weight loss.
Tough to answer in a single study With the fixed dose combination with betralandide and three eight eight, obviously, phase two data will provide us, the necessary information to understand, which doses can optimize the clinical response, but balancing what Adam and I have both referred to, which is the tolerability and acceptability profile of each asset. We are discussing multiple options, but instead of maximizing each, I would say our goal in phase two will be to optimize each. I mean, we would anticipate that that is higher dose amylin based therapy, patralentide, at the maximally affected effective doses, if it in fact remains as well tolerated as we’ve seen in the early phase trials, while then adding what I’ll call an optimized, but not necessarily maximal dose of the incretin based therapy to provide additional weight loss, glycemic control for those with diabetes, potentially cardiovascular risk reduction. So, in discussions with our Roche partners you know, whether this will be, I’ll call it, a high petrelentide low three eight eight, high mid, or high high. I I think we collectively, the alliance with Roche, agree that if you go to high doses of both, you will achieve the greatest weight loss.
But, balancing that with an acceptability and tolerability profile where we think we can fully leverage the better tolerability of the amylin based therapy while still adding adequate or optimized doses of three eight eight. So that is our current strategy pending, all of us having line of sight to the phase two dosing data. And then finally, you know, creating a simplified dose escalation scheme as possible so you don’t have multiple doses or changes. Obviously, this is intended as a fixed dose co formulated asset. So phase two will teach us a great deal.
Great question and more to follow, Andy.
Andy Hsieh, Analyst, William Blair: Great. Thank you so much.
Conference Operator: Thank you. We will take our next question. Your next question comes from the line of Prakhar Agwara from Cantor. Please go ahead. Your line is open.
Adam Langer, Vice President, Investor Relations, Zealand Pharma0: Hi. Thank you so much for taking my questions, and, congrats on the quarter. So maybe first, there’s a massive disconnect between the stock price and the value of Petraventa described by Roche during the deal. I’m sure you’ll agree with that. And you have so much cash in hand and will have milestones from Roche next year with high probability of achievement.
So why not consider something like a share buyback given the disconnect? And if not share buyback, could you consider BD in the metabolic disease space as there are many opportunities out there, for example, in China? And then one clinical question. Coming out of ADA, the other question on the, cabozantinib data was the impact on CV and inflammation markers, which were more modest compared to GLP-1s, you know, even for cabrizema and cabozantinib. So what are your thoughts on these CV inflammation data and implications for petrizeprine when zupreme one reads out?
Thank you.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you. I will take the first question and hand over to David for the second. Remember that the announcement we announced the partnership with Roche in March and we closed in May is a historic and transformative partnership in that it’s a true co development and co commercialization partnership. It’s not a licensing agreement. We
David Kendall, Chief Medical Officer, Zealand Pharma: will
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: have in order to realize the full potential of the 50% value and future profits of not only petraintide but also the combination product of petraintide and CC-three eighty eight, we both have to carry our share or cover our share of the development costs. So it is incredibly important for us to be well funded as a company to deliver on that opportunity to have 50% of future profit from this partnership. Of course, we don’t have to invest into manufacturing, which us will carry all the manufacturing investments, but we will have to carry our share of the development cost and the prelaunch cost. So, for me, it is actually more important to make sure that we stay as well capitalized as possible so we can deliver on our commitments into this partnership. The last thing I want to do is to put Zealand in a position where we cannot honor our financial obligations into the partnership.
So while we are extremely well capitalized, we also believe it is super important for us to be in a position where we can continue to honor our obligations from a financial perspective. And also recognizing that we are a company we are an innovation company, we are biotech company, who have delivered again and again great innovations. We do expect to continue to invest in the rest of the pipeline to deliver on our ambition to become a leading player in the obesity space and the associated diseases. We think we have a significant opportunity to leverage our twenty five years of expertise and experience in peptide drug discovery and development and tap into these unique opportunities that are now coming true in obesity and all these related diseases. So you should not expect a share buyback program from C9.
And on the next question, David, I will hand over to you.
David Kendall, Chief Medical Officer, Zealand Pharma: Yep. Thank you, Adam. And Prakhar, a very important question, and we saw what you and others did in the KEGRI data. I will simply state that while amylin based therapies clearly are not GLP one based therapies, GLP ones have demonstrated cardiovascular risk reduction in both diabetes and obesity, likely have pleiotropic effects due to receptors on multiple tissues. The both the the magnitude and direction of CV risk markers for us in our early phase program with limited data in the broader category program, including their phase two readouts, still demonstrate directionally what we consider very positive evidence that blood pressure, potentially markers of inflammation, and body weight, three very important determinants of CV risk.
There’s also nonclinical evidence of direct effects of amylin agonism on cardiac tissues, not through receptors, but likely through other mechanisms, either through vagal afferents or through body weight reduction. So in our mind, and as Adam alluded to, we are not looking to go toe to toe with GLP ones. We are looking to develop a unique class with unique benefits. You and I discussed at a recent fireside chat that one sure way not to get cardio protection from g o p one based therapy will be that you cannot take it or will not take it due to tolerability issues. So we strive to leverage our data with betralandide and the program looking at cardiovascular outcomes to determine if amylin based agonist with these improvements in risk markers can and will, as we would hypothesize, reduce cardiovascular risk.
So, yes, lesser magnitude, but to us both directionally and more broadly across clinical programs, evidence that cardiovascular risk markers all trend in the direction that will support cardioprotection from amylin based therapies, including petrolantide.
Adam Stingsberg, 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 Serena Shen from Wells Fargo. Please go ahead. Your line is open.
Speaker 7: Hi. Thanks for taking my question. So I wanted to ask what you think is the real addressable market opportunity for patients who cannot tolerate GLP-one since we’ve heard anecdotally from doctors that discontinuation due to tolerability is fairly low and much less than that 60% discontinuation within one year that’s commonly cited. Was curious perhaps what your market research indicates is the real discontinuation rate from the more current GLP-1s like semaglutide and tirzepatide? Thank you.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you for the question. And I think it’s, number one, I think we have clearly witnessed that once these molecules are utilized in a clinical setting with perhaps sometimes less experienced prescribers, discontinuation rate remains very high. I think David alluded to another extremely important question, and that is around acceptability. Remember that right now we are in a world where there’s no alternatives. So at least one opportunity or one situation we could be in is that people are actually ready to accept more side effects than if there was an alternative.
Imagine a world where there would be an alternative which would provide the same degree of weight loss but where you have less GI side effects, where you do not lose your appetite and your interest in food but more feel full faster and thus can enjoy social events around food. I think history has shown us that people, once they have choices, will actually go for those choices. And if there are choices, people are ready to accept less than if there is only one solution. So, we are quite firm not only considering the discontinuation rates we have seen today but also anticipating that if there is a more tolerable approach, acceptability would actually drop even further for the current therapies our ambition to position patreonitide as a future foundational therapy for those patients who want to potentially have a more pleasant weight loss experience if we can continue to deliver on the data that we have seen thus far with this molecule. Thank you.
Conference Operator: Thank you. We will take our next question. Your next question comes from the line of Yihan Lee from Barclays. Please go ahead. Your line is open.
Adam Langer, Vice President, Investor Relations, Zealand Pharma1: Hi. Yeehan from Barclays. Thank you for taking our questions. So I have two. The first one is on patterning tide.
So, again, thanks for sharing the baseline data. So actually, based on our very quick calculation according to what the patterodine type showed in phase one b, it seems like based on your like, the today’s shared baseline data, it seems patterodine type could potentially reach a run, like, 10% loss at week sixteen in the Zoom trial after adjusting, you know, male female ratio, baseline BMI, and, you know, slow slow titration schedule. So I think it’s indicating very promising to reach the COVID, like, around thirteen to fifteen week loss at forty two weeks. Just curious. Is this something you are looking for?
And, also, could you please remind us what kind of parameters you will share in the top line in the first half of next year, and we should expect an investor call post the PR. Right? And the second line, actually, is kind of like a follow-up. It’s kind of like, you know, the the efficacy durability for the. So because we saw at ADA, like, the REDEFINE one trial from Novo, the tagline leading type had a relatively slow week loss from around forty four weeks versus semaglutide or actually showed a very clear continued weight loss post forty four weeks.
So there are some concerns or more of a question mark for me, like how amylin class may produce, I don’t know, like, early weight loss, but the the efficacy may potentially win faster than the GLP once over time. So just curious how should we think about this with loss durability of the amiclav? Thank you very much.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you for your question, and maybe I’ll just answer quickly. So we were actually quite impressed to see cagrelinotide at the dose of two point four milligram delivering close to 12% weight loss in a sixty eight week study because we consider two point four milligram of cadreotide to be a very low dose of amylin compared to the nine milligrams we are testing now with much higher of our amylin analog with much higher bioavailability. And at least as one comparison, I think if you consider utilizing a very low dose of a TLT1, you would also at one point see that there would not continue to be weight loss. So we are excited about the potential for us to test even higher doses as, of course, as you also alluded to, we would expect higher doses to provide more weight loss and thus also the ability to achieve longer term continuous weight loss. We, of course, as David also alluded to in his prepared remarks, very aware of the fact that in general women or females lose more weight in these studies than males.
We had only around twenty percent in our phase one studies. Now it would be just around fifty percent females in the upcoming phase two. And most often, people report from the phase three trials around 60 to 65 up to seventy percent females. So there’s, of course, an opportunity here that just the trial design and the inclusion of the patients into these studies can help on the numbers. What we are firmly focused on is to achieve a weight loss that hits that bar of around 15% to 20% weight loss in the most pleasant way for a patient.
So we somehow refuse to be into a very tight numbers game as long as we are confident that based on our twenty eight and forty two weeks data that we can achieve that 15 to 20% weight loss in a phase three study, we and with a very pleasant experience and less side effects, we will be extremely bullish for the opportunity for patisiran side. Thank you.
Adam Langer, Vice President, Investor Relations, Zealand Pharma1: Thank you so much.
Conference Operator: Thank you. We will take our next question. If I could also ask participants to limit yourself to one question only for the interest of time. And your next question comes from the line of Sophia Graf Boulnisson from JPMorgan. Please go ahead.
Your line is open.
Adam Langer, Vice President, Investor Relations, Zealand Pharma1: Good afternoon. Thanks for taking my question. Could you provide any updated thoughts on how you see the opportunity in NASH, not only in light of the upcoming survey data, but also with the potential label expansion for Wegovy in The U. S. In the second half?
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you for that question. And I think it’s highly relevant. It’s, you know, as we have also tried to indicate in our call today, I think perhaps people do not ascribe significant and enough value and also you can say opportunity around the servulotype franchise. I think we still need to realize, most people still need to realize that up to thirty five percent of obese individuals have some degree of NASH. It is one of the most underserved consequences of living with NASH, and we only have one new FDA approved treatment for these, which provided around eleven percent EEs in fibrosis without worsening of NASH.
If you look into the data that Boehringer have presented last year in MAS with cerulotide, as they themselves described as groundbreaking, we will agree to that. It was approaching forty percent reduction in fibrosis without worsening of MAS. And then I would say then we are looking at something that can truly change the needle for those patients who live with that condition or at risk for that. I think if you look into the Phase III program that Bohringer are investing in MASH, which is, at least to our knowledge, by far the largest program, not only targeting F2 and F3, but also cirrhotic patients, including very strong commitments to follow these patients on to clinical outcomes. That’s a testament to also Boehringer’s belief in their ability to differentiate cerdulotide into this and provide a treatment option for these patients that can make a meaningful clinical impact.
Thank you.
Conference Operator: Thank you. We will take our next question. Your next question comes from the line of Benjamin Jackson from Jefferies. Please go ahead. Your line is open.
Adam Langer, Vice President, Investor Relations, Zealand Pharma2: Great. Thanks for the question. I’ll keep it short. Adam, I mean, specifically for you here, I guess, we’ve seen recently the market in the GLP-one sense develop to expand in a cash pay setting and a DTC setting. I think previously, we’ve you’ve had questions about whether you think that the obesity market ever could get to a state where it could be OTC, and this is probably one of the closest steps you can get towards it.
So I’m wondering what you’re thinking here in terms of Amylin and how you could whether you believe that is something you can position in a cash flow setting in the future or is very much, your focus being on a long term, long adherence population and market? So any thoughts or any changes in the way you envision the market developing, that would be great.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you for that question. And I think as you alluded to, it is, of course, something that we have been following closely, and we have also been clear in our statements around this. In order to ultimately address the obesity pandemic and all the diseases that follows, we need novel ways to get these products to patients and direct to consumer once you have enough safety and experience around them is one way to go for sure. The cash market, I think we’re already now seeing how important it is. Maybe people have been surprised how fast it has moved.
But I don’t think anyone could honestly question if it would come because we know how interested patients are in getting on these treatments, and the willingness to pay for these treatments has also been clear for a long time. So it’s just a matter of how fast it comes. And it really opens unique opportunities for companies like us and us as we enter the market. But of course, it’s something we have to discuss and plan for. But if you look at a profile like the one we have for Petrinsa, I would say that, of course, lends itself extremely well into that segment if it turns out that it is an easier prescription, it is an easier product to be on, and it will deliver the patients the weight loss that patients are looking for.
So I don’t see a disconnect between consumer payments and then long term, staying on treatment for a long term. I actually think a lot of patients would be willing to also pay for staying on treatment as long as their weight loss and weight maintenance experience is is one which they will accept. Thank you for the question. Thank you.
Conference Operator: Thank you. We will take our next question, and the question comes from the line of Julian Harrison from PDIG. Please go ahead. Your line is open. Hi.
This is Ray on for Julian. Thank you for taking our questions. You mentioned the value add effects and the importance of weight loss quality. Is there a number you would like to see on body composition in Supreme, or is less lean mass loss relative to existing therapies enough to translate into preference and practice?
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you for your question. We cannot provide a specific number. I would say, as David also alluded to, any weight loss program will be associated with some degree of muscle loss because you carry less weight. What we would be looking for in our program is, of course, that we don’t have exaggerated muscle wasting, as we may have seen with some of the GLP ones when you lose weight too fast and too dramatic, getting into a very negative energy balance and and reducing, increasing your insulin levels, etcetera. So we are probably we it’s too early to provide a number, but, healthy weight loss for us is one which at least did not exaggerate, the muscle wasting during the weight loss.
Thank you.
Speaker 7: Great. Thank you.
Conference Operator: Thank you. We will take our next question. And the question comes from the line of Jacob Mikhail from KBC Securities. Please go ahead. Your line is open.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Hi there, and thanks for taking my question. I have a question on the phase two trial for dapaglutide in an obesity linked, you know, condition in the second half of this year. Can you share what that condition would be? And given that there are multiple obesity obesity linked diseases that you can pick from, could you walk us through the criteria that you used to select that indication? Thanks for your question.
And it’s probably one quarter too early to share the specific indication, but we’ll come back in not that distinct future. But clearly, for us, it’s about differentiation. We don’t want to be among those companies who develop undifferentiated weight loss agents that do not make a true difference for patients.
Andy Hsieh, Analyst, William Blair: Okay. Thank you.
Conference Operator: Thank you. In the interest of time, we have one final question. And the final question comes from the line of Carsten Lamborne Medicine from Bank. I
Adam Langer, Vice President, Investor Relations, Zealand Pharma3: just had a question to Slide 10, where we share this gender data was quite impressive weight loss for the females in the trial. But at the same time, isn’t it also a little bit concerning to you that you see maybe no additional response or maybe even less response in the male part of the trial when doubling the dose from four point eight to nine milligram. I was interested to hear your view on this.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: I mean, David, I don’t know if you have further comments to this one. But number one, remember a small dataset. It could be again, we don’t know what doses are the right ones. That is what we explore in phase two. Even if you look at the mid dose or the four point five milligram dose, if you look at those numbers, you can say that could, of course, deliver the weight loss we are looking for also in a long term study.
That’s why we are entering the phase such a rich dose finding in phase two. When we looked into the early responses in phase one study, there was a tendency for differences in how fast these people lost weight. So we still would say believe that the higher doses could provide more regardless of the end number, and this study suggested that the two high doses were equally effective. David, any further comments?
David Kendall, Chief Medical Officer, Zealand Pharma: Yeah. I think two points, Adam. One, actually, in this cohort, the four point eight, we saw this group lose weight at similar doses more quickly. So that may have actually overemphasized, as Adam said, this small cohort, it’s difficult to differentiate. And you actually see in the two higher dose cohorts, particularly the nine milligram, there’s significant individual variation in a small dataset that can provide you a number of questions, but doesn’t provide the clarity.
I think the 480 plus participants in the full phase two b will be a better way to address that. The other is to be aware that there are cross weight loss approaches, and that’s diet and exercise as well as medical therapies. Women, on average, lose three to 5% more body weight or a year or more of exposure. So I think those are the things we weigh our gender, balance on, and, I think phase two will be a much more robust data set for us to address your question and the dose finding for us.
Adam Langer, Vice President, Investor Relations, Zealand Pharma3: Excellent. And then a small quick follow-up to that one, which is, also part of my first question but completely unrelated. In terms of phase three trials, we have learned so much about the obesity space over the last fifty two weeks that it’s developing rapidly all the time. Should we expect that, you’re planning for sort of a classic phase three setup with overweight, overweight diabetics, etcetera? Are there room for some new Phase III trials?
I’m thinking maybe sort of GLP-one naive or GLP-one failures where you could sort of differentiate PET three even more versus what someone might say.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you for your question, Kartik. And these are super important considerations, which we are discussing with us right now, and we will have to wait a little bit to provide updates. But I would kind of also say that since we are developing an alternative, it’s probably super important just to get out there. You don’t need to, as long as you provide the first alternative with a more pleasant side effect profile. Most patients do not stay on therapy on the GLP-1s today, so you don’t need to go on and convince the patients to stop taking something and then get on your new treatment.
Most patients who have been exposed to a GLP-one will, at the time we launch it, not be on a GLP-one. So this focus on shifting and so on from being on a GLP-one to getting to another modality, I think it’s less of an issue here because we know from market data that patients, most patients do not stay on GLP-one for a long time.
David Kendall, Chief Medical Officer, Zealand Pharma: Great. Thanks.
Adam Stingsberg, President and Chief Executive Officer, Zealand Pharma: Thank you. Thank you all for attending and for your questions today. We look very much forward to future announcements and updates and to connecting in the coming weeks and months.
Conference Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.
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