Full Year 2025 Zealand Pharma A/S Earnings Call
Speaker #3: Which includes phase 2 between data and multiple key readouts from the phase 3 program in obesity with cervical type. Moving to slide 5, obesity represents one of the greatest healthcare challenges of our time, not only because of its high and growing prevalence, but because of the long-term consequences of living with the disease.
Speaker #3: The longer people live with obesity, the greater the burden and the higher the risk of serious complications. Real-world data clearly shows that treatment persistence with GLP-1-based therapies remains a major challenge.
Operator: Good day, and thank you for standing by. Welcome to the Zealand Pharma Results Full Year 2025 Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Adam Lange, Vice President, Investor Relations. Please go ahead.
Speaker #3: To date, up to 12% of Americans have been exposed to a GLP-1-based therapy, yet only a small fraction remains in treatment. Approximately half of patients who discontinue GLP-1 therapies cite gastrointestinal adverse events as the primary reason.
Speaker #3: As a result, the key to unlocking the full value of this market is to develop therapies that deliver weight loss that patients desire, but with a better treatment experience that supports long-term use in a real world.
Adam Lange: Thank you, operator, and thank you to everyone for joining us today to discuss Zealand Pharma's results for the full year 2025. The related company announcement is available on our website at zealandpharma.com. As outlined on slide 2, I would like to remind listeners that during today's call, we will be making forward-looking statements that are subject to risks and uncertainties. Turning to slide 3 and today's agenda, I have with me on the call the following members of Zealand Pharma's management team: Adam Steensberg, President and Chief Executive Officer, Henriette Wennicke, Chief Financial Officer, and David Kendall, Chief Medical Officer. All speakers will be available for the Q&A session. Turning to slide 4, I will now hand the call over to Adam Steensberg, President and Chief Executive Officer. Adam?
Adam Lange: Thank you, operator, and thank you to everyone for joining us today to discuss Zealand Pharma's results for the full year 2025. The related company announcement is available on our website at zealandpharma.com. As outlined on slide two, I would like to remind listeners that during today's call, we will be making forward-looking statements that are subject to risks and uncertainties. Turning to slide three and today's agenda, I have with me on the call the following members of Zealand Pharma's management team: Adam Steensberg, President and Chief Executive Officer, Henriette Wennicke, Chief Financial Officer, and David Kendall, Chief Medical Officer. All speakers will be available for the Q&A session. Turning to slide 4, I will now hand the call over to Adam Steensberg, President and Chief Executive Officer. Adam?
Speaker #3: This leads me to slide 6. In many other chronic diseases, physicians typically have access to a broad range of therapeutic options that can be tailored to the needs of individual patients.
Speaker #3: In obesity, the treatment landscape remains comparatively narrow. Where we today rely on a single therapeutic category, while the GLP-1-based therapies clearly have advanced the field, they have not yet delivered what ultimately matters the most: long-term treatment persistence.
Speaker #3: Durable weight maintenance and sustained improvements in health outcomes. With Petrinitide, we see the potential to expand and strengthen the treatment paradigm for weight management.
Adam Steensberg: Thank you, Adam, and welcome everyone. 2025 was a breakthrough year for Zealand Pharma, especially considering the landmark partnership for petrelintide with Roche. As we end of 2026, we are moving into the most defining and catalyst-risked year for Zealand Pharma's history, which includes phase 2 petrelintide data and multiple key readouts from the phase 3 program in obesity with survodutide. Moving to slide 5. Obesity represents one of the greatest healthcare challenges of our time, not only because of its high and growing prevalence, but because of the long-term consequences of living with the disease. The longer people live with obesity, the greater the burden and the higher the risk of serious complications. Real-world data clearly shows that treatment persistence with GLP-1-based therapies remains a major challenge.
Adam Steensberg: Thank you, Adam, and welcome everyone. 2025 was a breakthrough year for Zealand Pharma, especially considering the landmark partnership for petrelintide with Roche. As we end of 2026, we are moving into the most defining and catalyst-risked year for Zealand Pharma's history, which includes phase 2 petrelintide data and multiple key readouts from the phase 3 program in obesity with survodutide. Moving to slide 5. Obesity represents one of the greatest healthcare challenges of our time, not only because of its high and growing prevalence, but because of the long-term consequences of living with the disease. The longer people live with obesity, the greater the burden and the higher the risk of serious complications. Real-world data clearly shows that treatment persistence with GLP-1-based therapies remains a major challenge.
Speaker #3: Moving to slide 7, the partnership we announced last year everything we had hoped for. And our teams are currently moving full steam ahead and focused on finalizing the design of the phase 3 program that we expect to initiate later this year.
Speaker #3: To position Petrinitide as a future foundational and first choice therapy for people living with overweight and obesity. I want to emphasize that this is a true, balanced partnership.
Speaker #3: This is reflected not only in the financial structure, where we share profits in the US and Europe, but also at the strategic level with shared development and commercialization rights for Petrinitide and Petrinitide-based combinations.
Speaker #3: This structure allows us to retain significant long-term value of the franchise, while preserving the strategic rights needed to support our ambition over the long term.
Adam Steensberg: To date, up to 12% of Americans have been exposed to a GLP-1-based therapy, yet only a small fraction remains in treatment. Approximately half of patients who discontinue GLP-1 therapies cite gastrointestinal adverse events as the primary reason. As a result, the key to unlocking the full value of this market is to develop therapies that deliver weight loss that patients desire, but with a better treatment experience that support long-term use in a real world. This leads me to slide 6. In many other chronic diseases, physicians typically have access to a broad range of therapeutic options that can be tailored to the needs of the individual patients. In obesity, the treatment landscape remains comparatively narrow, where we today rely on a single therapeutic category.
Adam Steensberg: To date, up to 12% of Americans have been exposed to a GLP-1-based therapy, yet only a small fraction remains in treatment. Approximately half of patients who discontinue GLP-1 therapies cite gastrointestinal adverse events as the primary reason. As a result, the key to unlocking the full value of this market is to develop therapies that deliver weight loss that patients desire, but with a better treatment experience that support long-term use in a real world. This leads me to slide 6. In many other chronic diseases, physicians typically have access to a broad range of therapeutic options that can be tailored to the needs of the individual patients. In obesity, the treatment landscape remains comparatively narrow, where we today rely on a single therapeutic category.
Speaker #3: Moving to slide 8, from one strong partner to another. Werner Ingelheim is positioned to lead the next wave of GLP-1-based innovation with cervical type.
Speaker #3: And we are very excited about the potential of cervical type to emerge as the preferred therapy for a large population of people with obesity and MASH.
Speaker #3: Liver disease is one of the most prevalent comorbidities associated with obesity. As Boehringer highlighted at Obesity Week last year, when you see obesity, think liver.
Speaker #3: And as one of our external speakers and the principal investigator in synchronized one noted at our Capital Markets Day: see obesity; think liver; treat the heart.
Speaker #3: This framing highlights the excitement for the upcoming phase 3 obesity data with cervical type including data from the cardiovascular outcome trial. Switching gears to our research efforts on slide 9.
Adam Steensberg: While the GLP-1-based therapies clearly have advanced the field, they have not yet delivered what ultimately matters the most: long-term treatment persistence, doable weight maintenance, and sustained improvements in health outcomes. With petrelintide, we see the potential to expand and strengthen the treatment paradigm for weight management. Moving to slide 7. The partnership we announced last year with Roche has delivered on everything we had hoped for, and our teams are currently moving full steam ahead, and focused on finalizing the design of the phase 3 program that we expect to initiate later this year, to position petrelintide as a future foundational and first-choice therapy for people living with overweight and obesity. I want to emphasize that this is a true balanced partnership.
Adam Steensberg: While the GLP-1-based therapies clearly have advanced the field, they have not yet delivered what ultimately matters the most: long-term treatment persistence, doable weight maintenance, and sustained improvements in health outcomes. With petrelintide, we see the potential to expand and strengthen the treatment paradigm for weight management. Moving to slide 7. The partnership we announced last year with Roche has delivered on everything we had hoped for, and our teams are currently moving full steam ahead, and focused on finalizing the design of the phase 3 program that we expect to initiate later this year, to position petrelintide as a future foundational and first-choice therapy for people living with overweight and obesity. I want to emphasize that this is a true balanced partnership.
Speaker #3: Our ambition extends beyond refining the near-term future of weight management. Over the coming period, we aim to build the most valuable metabolic health pipeline, supported by our competitive advantages with more than 25 years of expertise in peptide and metabolic health.
Speaker #3: Proprietary know-how and high-quality in-house data. Combined with rapid advancements in AI and machine learning, this strong foundation position us to remain at the forefront of innovation.
Speaker #3: While AI will improve efficiency across the industry, true differentiation comes from the quality and scale of proprietary data used to train these models. This is where we intend to focus our efforts.
Adam Steensberg: This is reflected not only in the financial structure, where we share profits in the US and Europe, but also at the strategic level, with shared development and commercialization rights for petrelintide and petrelintide-based combinations. This structure allows us to retain significant long-term value of the franchise while preserving the strategic rights needed to support our ambition over the long term. Moving to slide eight, from one strong partner to another. Boehringer Ingelheim is positioned to lead the next wave of GLP-1-based innovation with survodutide, and we are very excited about the potential of survodutide to emerge as the preferred therapy for a large population of people with obesity and MASH. Liver disease is one of the most prevalent comorbidities associated with obesity.
Adam Steensberg: This is reflected not only in the financial structure, where we share profits in the US and Europe, but also at the strategic level, with shared development and commercialization rights for petrelintide and petrelintide-based combinations. This structure allows us to retain significant long-term value of the franchise while preserving the strategic rights needed to support our ambition over the long term. Moving to slide eight, from one strong partner to another. Boehringer Ingelheim is positioned to lead the next wave of GLP-1-based innovation with survodutide, and we are very excited about the potential of survodutide to emerge as the preferred therapy for a large population of people with obesity and MASH. Liver disease is one of the most prevalent comorbidities associated with obesity.
Speaker #3: Our goal over the next five years is to advance more than 10 candidates into the clinic and set industry-leading cycle times from idea to the clinic.
Speaker #3: In a field historically characterized by long and complex development cycles, the pace of innovation is accelerating, and we intend to lead that. With that, I will turn over to David.
Speaker #4: Thank you, Adam. I will begin with an overview of our pipeline, shown on slide 10. Zealand Pharma is in a unique position today, with the potential to achieve five product launches over the next five years.
Speaker #4: We are also embarking upon a data-rich period ahead with important results from many of our clinical programs. All told, this represents an incredibly exciting and highly compelling path forward for our company.
Speaker #4: Let's turn to slide 11 in the ZooPreem One trial with petrolentide. We look forward to reporting top-line data from the phase 2 ZooPreem One trial this quarter.
Adam Steensberg: As Berner highlighted at Obesity Week last year, "When you see obesity, think liver." And as one of our external speakers and the principal investigator in SYNCHRONIZE-1 noted at our Capital Markets Day, "See obesity, think liver, treat the heart." This framing highlights the excitement for the upcoming phase III obesity data with survodutide, including data from the cardiovascular outcome trial. Switching gears to our research efforts on Slide 9. Our ambition extends beyond refining the near-term future of weight management. Over the coming period, we aim to build the most valuable metabolic health pipeline, supported by our competitive advantages with more than 25 years of expertise in peptide and metabolic health, proprietary know-how, and high-quality in-house data. Combined with rapid advancements in AI and machine learning, this strong foundation positions us to remain at the forefront of innovation.
Adam Steensberg: As Berner highlighted at Obesity Week last year, "When you see obesity, think liver." And as one of our external speakers and the principal investigator in SYNCHRONIZE-1 noted at our Capital Markets Day, "See obesity, think liver, treat the heart." This framing highlights the excitement for the upcoming phase III obesity data with survodutide, including data from the cardiovascular outcome trial. Switching gears to our research efforts on Slide 9. Our ambition extends beyond refining the near-term future of weight management. Over the coming period, we aim to build the most valuable metabolic health pipeline, supported by our competitive advantages with more than 25 years of expertise in peptide and metabolic health, proprietary know-how, and high-quality in-house data. Combined with rapid advancements in AI and machine learning, this strong foundation positions us to remain at the forefront of innovation.
Speaker #4: This trial is evaluating the efficacy and safety of petrolentide in participants with overweight or obesity without coexisting type 2 diabetes. ZooPreem One is a dose-finding trial assessing five dose levels of petrolentide administered weekly versus placebo over 42 weeks of active treatment.
Speaker #4: The trial includes monthly dose escalation over a period of up to 16 weeks followed by maintenance doses of up to 9 milligrams. The study's primary endpoint assesses change in body weight at week 28.
Speaker #4: However, top-line readout will also include important efficacy and safety measures at week 42. As previously shared, ZooPreem One enrolled a population of 494 participants with a mean baseline BMI of approximately 37 kilograms per meter squared and includes a balanced distribution of females and males.
Speaker #4: This population differs meaningfully from those studied in our phase 1 trials, and also from populations enrolled in recent phase 2 and phase 3 clinical trials of other analogs.
Adam Steensberg: While AI will improve efficiency across the industry, true differentiation comes from the quality and scale of proprietary data used to train these models. This is where we intend to focus our efforts. Our goal over the next 5 years is to advance more than 10 candidates into the clinic and set industry-leading cycle times from idea to the clinic. In a field historically characterized by long and complex development cycles, the pace of innovation is accelerating, and we intend to lead that. With that, I will turn over to David.
Adam Steensberg: While AI will improve efficiency across the industry, true differentiation comes from the quality and scale of proprietary data used to train these models. This is where we intend to focus our efforts. Our goal over the next 5 years is to advance more than 10 candidates into the clinic and set industry-leading cycle times from idea to the clinic. In a field historically characterized by long and complex development cycles, the pace of innovation is accelerating, and we intend to lead that. With that, I will turn over to David.
Speaker #4: Moving to slide 12 for a reminder of our ongoing plans for petrolentide. Together with our partner Roche, we are looking forward to leveraging insights from the ZooPreem One trial to inform the final design of a comprehensive and ambitious phase 3 development program for petrolentide in weight management.
Speaker #4: We expect to initiate the Phase 3A registrational trials for petrolentide monotherapy later this year, which will be followed by a comprehensive Phase 3B program designed to further expand and unlock the full value of petrolentide.
Speaker #4: With Phase 2 data approaching, I would like to briefly revisit our target product profile for petrolentide. Our goal with petrolentide is to deliver the level of weight loss that the vast majority of people living with overweight and/or obesity are seeking.
David Kendall: Thank you, Adam. I will begin with an overview of our pipeline, shown on Slide 10. Zealand Pharma is in a unique position today, with the potential to achieve five product launches over the next five years. We are also embarking upon a data-rich period ahead, with important results from many of our clinical programs. All told, this represents an incredibly exciting and highly compelling path forward for our company. Let's turn to Slide 11 and the ZUPREME-1 trial with petrelintide. We look forward to reporting top-line data from the Phase 2 ZUPREME-1 trial this quarter. This trial is evaluating the efficacy and safety of petrelintide in participants with overweight or obesity without coexisting type 2 diabetes. ZUPREME-1 is a dose-finding trial assessing five dose levels of petrelintide administered weekly versus placebo over 42 weeks of active treatment.
David Kendall: Thank you, Adam. I will begin with an overview of our pipeline, shown on Slide 10. Zealand Pharma is in a unique position today, with the potential to achieve five product launches over the next five years. We are also embarking upon a data-rich period ahead, with important results from many of our clinical programs. All told, this represents an incredibly exciting and highly compelling path forward for our company. Let's turn to Slide 11 and the ZUPREME-1 trial with petrelintide. We look forward to reporting top-line data from the Phase 2 ZUPREME-1 trial this quarter. This trial is evaluating the efficacy and safety of petrelintide in participants with overweight or obesity without coexisting type 2 diabetes. ZUPREME-1 is a dose-finding trial assessing five dose levels of petrelintide administered weekly versus placebo over 42 weeks of active treatment.
Speaker #4: While also providing an improved patient experience to further enhance the use of petrolentide for long-term treatment. Accordingly, a successful outcome for us would be data that reinforces our confidence in petrolentide's potential to achieve approximately 15 to 20 percent body weight reduction in longer-term phase 3 trials.
Speaker #4: Together with a safety and tolerability profile that represents a significantly better experience relative to Incretin-based therapies, firmly establishing petrolentide as a foundational therapy for the management of overweight and obesity.
Speaker #4: In parallel, we are excited about the opportunity to explore petrolentide as a backbone for future combination therapies. Petrolentide, in combination with the dual GLP-1/GIP receptor agonist CT388, is the first combination being developed in our alliance with Roche.
David Kendall: The trial includes monthly dose escalation over a period of up to 16 weeks, followed by maintenance doses of up to 9 milligrams. The study's primary endpoint assesses change in body weight at week 28. However, top-line readout will also include important efficacy and safety measures at week 42. As previously shared, ZUPREME-1 enrolled a population of 494 participants with a mean baseline BMI of approximately 37 kg/m² and includes a balanced distribution of females and males. This population differs meaningfully from those studied in our phase I trials and also from populations enrolled in recent phase II and phase III clinical trials of other amylin analogs. Moving to slide 12, for a reminder of our ongoing plans for petrelintide.
David Kendall: The trial includes monthly dose escalation over a period of up to 16 weeks, followed by maintenance doses of up to 9 milligrams. The study's primary endpoint assesses change in body weight at week 28. However, top-line readout will also include important efficacy and safety measures at week 42. As previously shared, ZUPREME-1 enrolled a population of 494 participants with a mean baseline BMI of approximately 37 kg/m² and includes a balanced distribution of females and males. This population differs meaningfully from those studied in our phase I trials and also from populations enrolled in recent phase II and phase III clinical trials of other amylin analogs. Moving to slide 12, for a reminder of our ongoing plans for petrelintide.
Speaker #4: Zealand Pharma and Roche remain on track to initiate the Phase 2 trial of the petrolentide CT388 combination in the first half of this year.
Speaker #4: Now turning to slide 13 in servotetide. A glucagon GLP-1 receptor dual agonist that we believe has the potential to play an important role in the next phase of innovation in obesity and metabolic disease.
Speaker #4: In the first half of 2026, we look forward to the results from the 76-week synchronized one trial which is evaluating the safety and efficacy of servotetide in people with overweight or obesity without type 2 diabetes.
Speaker #4: In the prior 46-week phase 2 obesity trial, servotetide demonstrated very compelling and competitive weight loss of up to 19 percent. Beyond synchronized one, we expect additional readouts from the broader phase 3 obesity program over the course of 2026.
David Kendall: Together with our partner, Roche, we are looking forward to leveraging insights from the ZUPREME-1 trial to inform the final design of a comprehensive and ambitious Phase III development program for petrelintide in weight management. We expect to initiate the Phase IIIa registrational trials for petrelintide monotherapy later this year, which will be followed by a comprehensive Phase IIIb program designed to further expand and unlock the full value of petrelintide. With Phase II data approaching, I would like to briefly revisit our target product profile for petrelintide. Our goal with petrelintide is to deliver the level of weight loss that the vast majority of people living with overweight and obesity are seeking, while also providing an improved patient experience to further enhance the use of petrelintide for long-term treatment.
David Kendall: Together with our partner, Roche, we are looking forward to leveraging insights from the ZUPREME-1 trial to inform the final design of a comprehensive and ambitious Phase III development program for petrelintide in weight management. We expect to initiate the Phase IIIa registrational trials for petrelintide monotherapy later this year, which will be followed by a comprehensive Phase IIIb program designed to further expand and unlock the full value of petrelintide. With Phase II data approaching, I would like to briefly revisit our target product profile for petrelintide. Our goal with petrelintide is to deliver the level of weight loss that the vast majority of people living with overweight and obesity are seeking, while also providing an improved patient experience to further enhance the use of petrelintide for long-term treatment.
Speaker #4: Together, these data are expected to support the first regulatory submissions for servotetide. We are also excited and extremely encouraged by the ongoing Phase 3 program evaluating servotetide in people with metabolic dysfunction-associated steatohepatitis, or MASH.
Speaker #4: This program includes two trials assessing safety and efficacy in patients with moderate to advanced fibrosis, as well as in those with cirrhosis. Given the high unmet medical need and limited treatment options for this population, we believe servotetide has the potential to become a key therapeutic option for people living with overweight or obesity and coexisting MASH.
David Kendall: Accordingly, a successful outcome for us would be data that reinforces our confidence in petrelintide's potential to achieve approximately 15% to 20% body weight reduction in the longer-term phase 3 trials, together with a safety and tolerability profile that represents a significantly better experience relative to incretin-based therapies, firmly establishing petrelintide as a foundational therapy for the management of overweight and obesity. In parallel, we are excited about the opportunity to explore petrelintide as a backbone for future combination therapies. Petrelintide, in combination with the dual GLP-1/GIP receptor agonist CT-388, is the first combination being developed in our alliance with Roche. Zealand Pharma and Roche remain on track to initiate the phase 2 trial of the petrelintide/CT-388 combination in the first half of this year.
David Kendall: Accordingly, a successful outcome for us would be data that reinforces our confidence in petrelintide's potential to achieve approximately 15% to 20% body weight reduction in the longer-term phase 3 trials, together with a safety and tolerability profile that represents a significantly better experience relative to incretin-based therapies, firmly establishing petrelintide as a foundational therapy for the management of overweight and obesity. In parallel, we are excited about the opportunity to explore petrelintide as a backbone for future combination therapies. Petrelintide, in combination with the dual GLP-1/GIP receptor agonist CT-388, is the first combination being developed in our alliance with Roche. Zealand Pharma and Roche remain on track to initiate the phase 2 trial of the petrelintide/CT-388 combination in the first half of this year.
Speaker #4: Let's now turn to slide 14 in our novel KD1.3 exhibitor. Yesterday, we announced positive top-line results from the first inhuman randomized double-blind placebo-controlled phase 1 trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZP9830.
Speaker #4: Following a single administration to healthy male subjects, ZP9830 was very well tolerated with no serious or severe AEs or dose-limiting safety findings at any of the dose levels tested.
Speaker #4: PK parameters increased in a dose-proportional manner across the investigated dose range, in line with predictions based on preclinical data. We are very pleased with the results of this trial, which are very well aligned with our expectations, reinforcing our confidence in our KD1.3 channel blocker as a very promising drug candidate with the potential to target multiple autoimmune and inflammatory diseases.
David Kendall: Now, turning to Slide 13 and survodutide, a glucagon GLP-1 receptor dual agonist that we believe has the potential to play an important role in the next phase of innovation in obesity and metabolic disease. In the first half of 2026, we look forward to the results from the 76-week SYNCHRONIZE-1 trial, which is evaluating the safety and efficacy of survodutide in people with overweight or obesity without type 2 diabetes. In the prior 46-week phase 2 obesity trial, survodutide demonstrated very compelling and competitive weight loss of up to 19%. Beyond SYNCHRONIZE-1, we expect additional readouts from the broader phase 3 obesity program over the course of 2026. Together, these data are expected to support the first regulatory submissions for survodutide. We are also excited and extremely encouraged by the ongoing phase 3 program, evaluating survodutide in people with metabolic dysfunction associated steatohepatitis, or MASH.
David Kendall: Now, turning to Slide 13 and survodutide, a glucagon GLP-1 receptor dual agonist that we believe has the potential to play an important role in the next phase of innovation in obesity and metabolic disease. In the first half of 2026, we look forward to the results from the 76-week SYNCHRONIZE-1 trial, which is evaluating the safety and efficacy of survodutide in people with overweight or obesity without type 2 diabetes. In the prior 46-week phase 2 obesity trial, survodutide demonstrated very compelling and competitive weight loss of up to 19%. Beyond SYNCHRONIZE-1, we expect additional readouts from the broader phase 3 obesity program over the course of 2026. Together, these data are expected to support the first regulatory submissions for survodutide. We are also excited and extremely encouraged by the ongoing phase 3 program, evaluating survodutide in people with metabolic dysfunction associated steatohepatitis, or MASH.
Speaker #4: We look forward to reporting top-line results from the multiple ascending dose portion of this trial and progress ZP9830 into phase 1B2A development in the second half of 2026.
Speaker #4: With that, thank you very much for your attention. I would now like to turn the call over to our chief financial officer, Henriette Wennicke, who will review our financial results for 2025.
Speaker #4: Henriette?
Speaker #5: Thanks, David. And hello, everyone. Let's turn to slide 15 and the income statement. Revenue for the full year of 2025 was $9.2 billion BKK.
Speaker #5: Driven by the initial upfront payment received under the collaboration and license agreement with Roche. The net operating expenses excluding other operating items totaled $2.1 billion BKK in 2025.
Speaker #5: And what within the guidance range of 2 to 2.3 billion DKK. Seventy-six percent of the net operating expenses in 2025 were dedicated to research and development, mainly driven by the clinical advancement of the petrolentide program, including the two Phase 2 trials, and the preparation for Phase 3.
David Kendall: This program includes two trials assessing safety and efficacy in patients with moderate to advanced fibrosis, as well as in those with cirrhosis. Given the high unmet medical need and limited treatment options for this population, we believe survodutide has the potential to become a key therapeutic option for people living with overweight or obesity and coexisting MASH. Let's now turn to slide 14 and our novel Kv1.3 inhibitor. Yesterday, we announced positive top-line results from the first in-human randomized, double-blind, placebo-controlled phase 1 trial, evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZP9830, following a single administration to healthy male subjects. ZP9830 was very well tolerated, with no serious or severe AEs or dose-limiting safety findings at any of the dose levels tested.
David Kendall: This program includes two trials assessing safety and efficacy in patients with moderate to advanced fibrosis, as well as in those with cirrhosis. Given the high unmet medical need and limited treatment options for this population, we believe survodutide has the potential to become a key therapeutic option for people living with overweight or obesity and coexisting MASH. Let's now turn to slide 14 and our novel Kv1.3 inhibitor. Yesterday, we announced positive top-line results from the first in-human randomized, double-blind, placebo-controlled phase 1 trial, evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZP9830, following a single administration to healthy male subjects. ZP9830 was very well tolerated, with no serious or severe AEs or dose-limiting safety findings at any of the dose levels tested.
Speaker #5: The SOM expenses are driven by the pre-commercial activities associated with mainly petrolentide, while G&A expenses reflect a strengthening of organizational capabilities. Investments in IT infrastructure and legal expenses related to the patent portfolio.
Speaker #5: This resulted in a net positive result of $6.5 billion BKK for the year. Let's move to slide 16 and the financial position. We ended the year of 2025 with a strong cash position of 15.1 billion BKK.
Speaker #5: Our cash position was strengthened during the year by the initial upfront payment of ฿9.2 billion from Roche, partly offset by the operating expenses during the period.
David Kendall: PK parameters increased in a dose proportional manner across the investigated dose range, in line with predictions based on preclinical data. We are very pleased with the results of this trial that are very well aligned with our expectations, reinforcing our confidence in our Kv1.3 channel blocker as a very promising drug candidate, with the potential to target multiple autoimmune and inflammatory diseases. We look forward to reporting top-line results from the multiple ascending dose portion of this trial and progressing ZP9830 into phase 1b/2a development in the second half of 2026. With that, thank you very much for your attention. I would now like to turn the call over to our Chief Financial Officer, Henriette Wennicke, who will review our financial results for 2025. Henriette?
David Kendall: PK parameters increased in a dose proportional manner across the investigated dose range, in line with predictions based on preclinical data. We are very pleased with the results of this trial that are very well aligned with our expectations, reinforcing our confidence in our Kv1.3 channel blocker as a very promising drug candidate, with the potential to target multiple autoimmune and inflammatory diseases. We look forward to reporting top-line results from the multiple ascending dose portion of this trial and progressing ZP9830 into phase 1b/2a development in the second half of 2026. With that, thank you very much for your attention. I would now like to turn the call over to our Chief Financial Officer, Henriette Wennicke, who will review our financial results for 2025. Henriette?
Speaker #5: Our strong capital preparedness enabled us to meet all obligations under the collaboration with Roche for petrolentide, including the comprehensive phase 3 program. It will also allow us to intensify our efforts in building a leading metabolic health pipeline and deliver on our metabolic frontier 2030 strategy.
Speaker #5: Let's turn to slide 17 and the outlook for the year. For 2026, we guide for net operating expenses to be in the range of $2.72 to $3.3 billion BKK.
Speaker #5: Mainly driven by research and development activities. On the development side, key cost drivers include the expected initiation of a phase 3A program with petrolentide monotherapy, and the initiation of a phase 2 trial with petrolentide CT388 combination.
Henriette Wennicke: Thanks, David, and hello, everyone. Let's turn to slide 15 and the income statement. Revenue for the full year of 2025 was DKK 9.2 billion, driven by the initial upfront payment received under the collaboration and license agreement with Roche. The net operating expenses, excluding other operating items, totaled DKK 2.1 billion in 2025, and was within the guidance range of DKK 2 to 2.3 billion. 76% of the net operating expenses in 2025 were dedicated to research and development, mainly driven by the clinical advancement of the proturnetide program, including the two phase 2 trials and the preparation for phase 3. The FIM expenses are driven by the pre-commercial activities associated with mainly proturnetide, while G&A expenses reflect a strengthening of organizational capabilities, investments in IT infrastructure, and legal expenses related to the patent portfolio.
Henriette Wennicke: Thanks, David, and hello, everyone. Let's turn to slide 15 and the income statement. Revenue for the full year of 2025 was DKK 9.2 billion, driven by the initial upfront payment received under the collaboration and license agreement with Roche. The net operating expenses, excluding other operating items, totaled DKK 2.1 billion in 2025, and was within the guidance range of DKK 2 to 2.3 billion. 76% of the net operating expenses in 2025 were dedicated to research and development, mainly driven by the clinical advancement of the proturnetide program, including the two phase 2 trials and the preparation for phase 3. The FIM expenses are driven by the pre-commercial activities associated with mainly proturnetide, while G&A expenses reflect a strengthening of organizational capabilities, investments in IT infrastructure, and legal expenses related to the patent portfolio.
Speaker #5: In addition, strengthen our research engine is critical to realizing our vision of building a leading metabolic health pipeline and the guidance therefore also reflects a step up in research cost.
Speaker #5: Overall, the anticipated OPEX spends reflect the momentum we have built into 2026 and position Ceylon Pharma to leverage the future growth opportunities. And even though we only provide guidance on operating expenses, I would like to take the opportunity to remind you that Ceylon Pharma is eligible for potential milestone payments from Roche of $700 million US dollars in 2026.
Speaker #5: This includes an anniversary payment of $125 million US dollars, and the potential development milestone payment of $575 million US dollars, which is subject to initiation of a phase 3A program with petrolentide monotherapy.
Speaker #5: Finally, let's move to slide 18 and our sustainability efforts. As a biotech company, we place the health and well-being of patients at the center of everything we do.
Henriette Wennicke: This resulted in a net positive result of DKK 6.5 billion for the year. Let's move to slide 16 and the financial position. We ended the year of 2025 with a strong cash position of DKK 15.1 billion. Our cash position was strengthened during the year by the initial upfront payment of DKK 9.2 billion from Roche, partly offset by the operating expenses during the period. Our strong capital preparedness enabled us to meet all obligations under the collaboration with Roche petrelintide, including the comprehensive phase 3 program. It will also allow us to intensify our efforts in building a leading metabolic health pipeline and deliver on our Metabolic Frontier 2030 strategy. Let's turn to slide 17 and the outlook for the year.
Henriette Wennicke: This resulted in a net positive result of DKK 6.5 billion for the year. Let's move to slide 16 and the financial position. We ended the year of 2025 with a strong cash position of DKK 15.1 billion. Our cash position was strengthened during the year by the initial upfront payment of DKK 9.2 billion from Roche, partly offset by the operating expenses during the period. Our strong capital preparedness enabled us to meet all obligations under the collaboration with Roche petrelintide, including the comprehensive phase 3 program. It will also allow us to intensify our efforts in building a leading metabolic health pipeline and deliver on our Metabolic Frontier 2030 strategy. Let's turn to slide 17 and the outlook for the year.
Speaker #5: And our ability to assure advance our pipeline and ultimately serve patients best on our people. We are extremely proud that while we increased our headcounts by 41 percent in 2025, we maintained a very high engagement employee engagement score of 8.9 on a 10-point scale.
Speaker #5: And at the same time, we maintained our employee turnover rate at just 7.8%. We believe this is a testament to our unique company culture and our continued dedication to fostering an engaging and enriching workplace.
Speaker #5: This makes us confident that we have built a sustainable organization setup capable of supporting our long-term aspirations. We are also committed to taking responsibility for the environmental impact of our operations.
Henriette Wennicke: For 2026, we guide for net operating expenses to be in the range of DKK 2.7 to 3.3 billion, mainly driven by research and development activities. On the development side, key cost drivers include the expected initiation of a Phase 3 program with petrelintide monotherapy and the initiation of a Phase 2 trial, the petrelintide + CT-388 combination. In addition, strengthen our research engine is critical to realizing our vision of building a leading metabolic health pipeline, and the guidance therefore also reflects a step up in research costs. Overall, the anticipated OpEx expense reflects the momentum we have built into 2026 and positions Zealand Pharma to leverage the future growth opportunities.
Henriette Wennicke: For 2026, we guide for net operating expenses to be in the range of DKK 2.7 to 3.3 billion, mainly driven by research and development activities. On the development side, key cost drivers include the expected initiation of a Phase 3 program with petrelintide monotherapy and the initiation of a Phase 2 trial, the petrelintide + CT-388 combination. In addition, strengthen our research engine is critical to realizing our vision of building a leading metabolic health pipeline, and the guidance therefore also reflects a step up in research costs. Overall, the anticipated OpEx expense reflects the momentum we have built into 2026 and positions Zealand Pharma to leverage the future growth opportunities.
Speaker #5: In 2025, we committed to the design-based targets initiative and joined the UN Global Compact. In 2026, we will continue our work to transition our company and collaborate closely with our business partners to mitigate climate change.
Speaker #5: And with that, I will move to slide 19 and turn the call back to Adam for closing remarks.
Speaker #6: Thank you, Henriette. Building on the momentum we created in 2025, we have entered the most catalyst-rich year in Ceylon Pharma's history, with defining data readouts expected for both of our leading obesity programs petrolentide and serverotide.
Speaker #6: As we execute on our metabolic frontier 2030 strategy, we are also highly energized to open our new research site in Boston this year, and to pursue additional partnerships that further strengthen and expand our pipeline.
Henriette Wennicke: Even though we only provide guidance on operating expenses, I would like to take the opportunity to remind you that Zealand Pharma is eligible for potential milestone payments for Roche of $700 million in 2026. This includes an anniversary payment of $125 million and a potential development milestone payment of $575 million, which is subject to initiation of a Phase 3 program with petrelintide monotherapy. Finally, let's move to slide 18 and our sustainability efforts. As a biotech company, we place the health and well-being of patients at the center of everything we do, and our ability to ensure advance our pipelines and ultimately serve patients rests on our people.
Henriette Wennicke: Even though we only provide guidance on operating expenses, I would like to take the opportunity to remind you that Zealand Pharma is eligible for potential milestone payments for Roche of $700 million in 2026. This includes an anniversary payment of $125 million and a potential development milestone payment of $575 million, which is subject to initiation of a Phase 3 program with petrelintide monotherapy. Finally, let's move to slide 18 and our sustainability efforts. As a biotech company, we place the health and well-being of patients at the center of everything we do, and our ability to ensure advance our pipelines and ultimately serve patients rests on our people.
Speaker #6: I will now turn over the call to the operator, and we will be happy to address your questions.
Speaker #7: Thank you. As a reminder, to ask a question you will need to press star one one on your telephone and wait for your name to be announced.
Speaker #7: We ask participants to ask one question only. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster.
Speaker #7: We will take our first question, and the question comes from the line of Hakon Hem from Danske Bank. Please go ahead. Your line is open.
Henriette Wennicke: We are extremely proud that while we increased our headcounts by 41% in 2025, we maintained a very high engagement, employee engagement score of 8.9 on a 10-point scale, and at the same time, we maintained our employee churn rate at just 7.8%. We believe this is a testament to our unique company culture and our continuous dedication to foster an engaging and enriching workplace. This makes us confident that we have built a sustainable organization setup, capable of supporting our long-term aspirations. We are also committed to taking responsibility for the environmental impact of our operations. In 2025, we committed to the science-based targets initiative and joined the UN Global Compact. In 2026, we will continue our work to transition our company and collaborate, and collaborate closely with our business partners to mitigate climate change.
Henriette Wennicke: We are extremely proud that while we increased our headcounts by 41% in 2025, we maintained a very high engagement, employee engagement score of 8.9 on a 10-point scale, and at the same time, we maintained our employee churn rate at just 7.8%. We believe this is a testament to our unique company culture and our continuous dedication to foster an engaging and enriching workplace. This makes us confident that we have built a sustainable organization setup, capable of supporting our long-term aspirations. We are also committed to taking responsibility for the environmental impact of our operations. In 2025, we committed to the science-based targets initiative and joined the UN Global Compact. In 2026, we will continue our work to transition our company and collaborate, and collaborate closely with our business partners to mitigate climate change.
Speaker #8: Great. Thank you for taking my question. In regards to the oncoming upcoming phase 2 readout of on petrolentide phase 2, the Supreme One, what level of details are you able to share with us on the day of the announcement, apart from the weight loss?
Speaker #8: Will you include data on petrolentide's tolerability profile in the announcement?
Speaker #6: Thank you, Håkon, for that question. So we can confirm that the data are anticipated this quarter, at which, of course, means also in the coming weeks, and we are highly anticipating being able to share the data broadly.
Speaker #6: We will, as we always do when we share top-line results, provide a balanced presentation of the data, while also reserving data that can be presented at scientific conferences later in the year.
Speaker #6: So you should expect a balanced view, which we'll discuss both top-line efficacy and safety tolerability. Thank you.
Henriette Wennicke: With that, I will move to slide 19 and turn the call back to Adam for closing remarks.
Henriette Wennicke: With that, I will move to slide 19 and turn the call back to Adam for closing remarks.
Speaker #8: Great. Thank you.
Speaker #7: Thank you. We will take our next question. Your next question comes from the line of Rajan Sharma from Goldman Sachs. Please go ahead. Your line is open.
Adam Steensberg: Thank you, Henriette. Building on the momentum we created in 2025, we have entered the most catalyst-rich year in Zealand Pharma's history, with defining data readouts expected for both of our leading obesity programs, petrelintide and survodutide. As we execute on our Metabolic Frontier 2030 strategy, we are also highly energized to open our new research site in Boston this year, and to pursue additional partnerships that further strengthen and expand our pipeline. I will now turn over the call to the operator, and we will be happy to address your questions.
Adam Steensberg: Thank you, Henriette. Building on the momentum we created in 2025, we have entered the most catalyst-rich year in Zealand Pharma's history, with defining data readouts expected for both of our leading obesity programs, petrelintide and survodutide. As we execute on our Metabolic Frontier 2030 strategy, we are also highly energized to open our new research site in Boston this year, and to pursue additional partnerships that further strengthen and expand our pipeline. I will now turn over the call to the operator, and we will be happy to address your questions.
Speaker #9: Hi. Thanks for taking my question. I just wanted to get your latest perspectives on competitive dynamics in the obesity market following the first oral launch.
Speaker #9: I know you’ve always been clear in the view that injectables will be the largest segment of the market. Has anything changed, given the launch trajectory of oral Wegovy?
Speaker #9: And then maybe just to add on that, where do you expect net price to be in obesity by the time petrolentide launches? Thank you.
Speaker #6: Thank you for your question. Rajan, and I think it's we have not our minds around the oral versus injectables have not changed due to the recent launches.
Operator: Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. We ask participants to ask one question only. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. We will take our first question, and the question comes from the line of Hakon Hem from Danske Bank. Please go ahead. Your line is open.
Operator: Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. We ask participants to ask one question only. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. We will take our first question, and the question comes from the line of Hakon Hemme from Danske Bank. Please go ahead. Your line is open.
Speaker #6: It's very important, and we remain you can say focused on the fact that the oral GLP-1s that are launching right now do not address the biggest what we consider the biggest issues with the GLP-1s, which is tolerability as we discussed in the prepared remarks.
Speaker #6: We have 50 percent of the patients who stop taking these medicines is due to adverse events related to the gastrointestinal tract. So while we do expect the oral options to expand the GLP-1 market, we do not think it will it's actually addressing the main issue around the current therapies that are around.
Håkon Hemme: Great, thank you for taking my question. In regards to the upcoming phase 2 readout on petrelintide phase 2, the ZUPREME-1, what level of details are you able to share with us on the day of the announcement? Apart from the weight loss, will you include the data on petrelintide's tolerability profile in the announcement?
Håkon Hemme: Great, thank you for taking my question. In regards to the upcoming phase 2 readout on petrelintide phase 2, the ZUPREME-1, what level of details are you able to share with us on the day of the announcement? Apart from the weight loss, will you include the data on petrelintide's tolerability profile in the announcement?
Speaker #6: And that's why we are so excited about being able to lead in a novel category, which we think has the potential to provide patients, as David discussed, the weight loss they are looking for, but with a more pleasant weight loss experience.
Speaker #6: And it's really back to the thing which we have also advocated for for a long time. Instead of having such a keen focus on prices, as an industry, we need to move the focus into how we help patients stay in therapy the key to unlock the value of the obesity market is to make sure that obesity medications are used as chronic therapies rather than event-based weight loss agents.
Adam Steensberg: Thank you, Hakon, for that question. So we can confirm that the data are anticipated this quarter, which of course means also in the coming weeks, and we are highly anticipating being able to share the data broadly. We will, as we always do, when we share top-line results, provide a balanced presentation of the data, while also reserving data that can be presented at scientific conferences later in the year. So you should expect a balanced view, which will discuss both top-line efficacy and safety tolerability.
Adam Steensberg: Thank you, Hakon, for that question. So we can confirm that the data are anticipated this quarter, which of course means also in the coming weeks, and we are highly anticipating being able to share the data broadly. We will, as we always do, when we share top-line results, provide a balanced presentation of the data, while also reserving data that can be presented at scientific conferences later in the year. So you should expect a balanced view, which will discuss both top-line efficacy and safety tolerability.
Speaker #6: And that's where we think petrolentide and the amyline category has the potential to unlock the market value for obesity. When it comes to prices, and which, of course, has a lot of focus right now in the current competitive environment, also with having had compounders around, it's again some dynamics that we have talked about for a long time.
Håkon Hemme: Thank you. Great. Thank you.
Håkon Hemme: Thank you. Great. Thank you.
Operator: Thank you. We will take our next question. Your next question comes from the line of Rajan Sharma from Goldman Sachs. Please go ahead. Your line is open.
Operator: Thank you. We will take our next question. Your next question comes from the line of Rajan Sharma from Goldman Sachs. Please go ahead. Your line is open.
Speaker #6: And the uniqueness about the obesity market is we have the more classical market where we have payers and insurance companies. And then we have the self-pay market.
Rajan Sharma: Hi, thanks for taking my question. I just wanted to get your latest perspectives on competitive dynamics in the obesity market following the first oral launch. I know you've always been clear in the view that injectables will be the largest segment of the market. Has anything changed given the launch trajectory of all Wegovy? And then maybe just to add on that, where do you expect net price to be in obesity by the time petrelintide launches? Thank you.
Rajan Sharma: Hi, thanks for taking my question. I just wanted to get your latest perspectives on competitive dynamics in the obesity market following the first oral launch. I know you've always been clear in the view that injectables will be the largest segment of the market. Has anything changed given the launch trajectory of all Wegovy? And then maybe just to add on that, where do you expect net price to be in obesity by the time petrelintide launches? Thank you.
Speaker #6: And you need to address both. Of course, when you launch with a new category, which may provide a much more pleasant weight loss experience, there will be novel dynamics also with regard to pricing.
Speaker #6: So while the GLP-1 dynamics will affect entrance into that market, we do anticipate that novel themes will play out when you launch novel categories just as we have seen in other therapeutic areas.
Adam Steensberg: Thank you for your question, Rajan. I think we have not our minds around the orals, which injectables have not changed due to the recent launches. It's very important, and we remain, you can say, focused on the fact that the old GLP-1 that are launching right now do not address the biggest, what we consider the biggest issues with the GLP-1s, which is solubility. As we discussed in the prepared remarks, we have 50% of the patients who stop taking these medicines due to adverse events related to the gastrointestinal tract.
Adam Steensberg: Thank you for your question, Rajan. I think we have not our minds around the orals, which injectables have not changed due to the recent launches. It's very important, and we remain, you can say, focused on the fact that the old GLP-1 that are launching right now do not address the biggest, what we consider the biggest issues with the GLP-1s, which is solubility. As we discussed in the prepared remarks, we have 50% of the patients who stop taking these medicines due to adverse events related to the gastrointestinal tract.
Speaker #6: So what is too early to provide any specifics on the net pricing when we launch petrolentide. Thank you, Rajan.
Speaker #9: Thank you.
Speaker #7: Thank you. We will take our next question. The next question comes from the line of Kirsty Ross Stewart from BNP Paribas. Please go ahead.
Speaker #7: Your line is open.
Speaker #10: Hi. Yes, Kirsty Ross Stewart from BNP Paribas. Thanks for taking my question. So, regarding the Phase 3b development for petrolentide, can you just expand a little bit on the types of opportunities you're hoping to unlock with the broader clinical trial program?
Adam Steensberg: So while we do expect that all the oral options to expand the GLP-1 market, we do not think it will; it's actually addressing the main issue around the current therapies that are around, and that's why we are so excited about being able to lead in a novel category, which we think have the potential to provide patients, as David discussed, the weight loss they are looking for, but a more pleasant weight loss experience. And it's really back to the thing which we have also advocated for, for a long time. Instead of having such a keen focus on prices, as an industry, we need to move the focus into how we help patients stay in therapy. The key to unlock the value of the obesity market-...
Adam Steensberg: So while we do expect that all the oral options to expand the GLP-1 market, we do not think it will; it's actually addressing the main issue around the current therapies that are around, and that's why we are so excited about being able to lead in a novel category, which we think have the potential to provide patients, as David discussed, the weight loss they are looking for, but a more pleasant weight loss experience. And it's really back to the thing which we have also advocated for, for a long time. Instead of having such a keen focus on prices, as an industry, we need to move the focus into how we help patients stay in therapy. The key to unlock the value of the obesity market-...
Speaker #10: And how much of the total opportunity do you believe is represented by the monotherapy? Is that kind of the majority part? Is that what we should be thinking as the main part?
Speaker #10: Or just are you seeing this as a small portion and just the tip of the iceberg? And just related to that, can you remind us on the financial obligations from you and Raj regarding the future phase 3B development?
Speaker #10: Thank you.
Speaker #6: Thank you for your question. I'll just start with a few remarks and then hand over to David. So as you know, our the focus for the team right now is to accelerate timelines to a potential launch of petrolentide.
Speaker #6: And in parallel, invest deeply in making sure that petrolentide will become a foundational and first choice therapy and thus also having the data foundation to support that positioning.
Adam Steensberg: is to make sure that obesity medications are used as chronic therapies rather than event-based weight loss agents. And that's where we think the triple and the amylin category has the potential to unlock the market value for obesity. When it comes to prices, and which, of course, has a lot of focus right now, in the current competitive environment, also with having had compounders around, it's again some dynamics that we have talked about for a long time. And the uniqueness about the obesity market is we have the more classical market, where we have payers and insurance companies, and then we have the self-pay market. And you need to address both.
Adam Steensberg: is to make sure that obesity medications are used as chronic therapies rather than event-based weight loss agents. And that's where we think the triple and the amylin category has the potential to unlock the market value for obesity. When it comes to prices, and which, of course, has a lot of focus right now, in the current competitive environment, also with having had compounders around, it's again some dynamics that we have talked about for a long time. And the uniqueness about the obesity market is we have the more classical market, where we have payers and insurance companies, and then we have the self-pay market. And you need to address both.
Speaker #6: And we will have shared we'll share all costs with our partner Ross in those efforts. It's clearly the monotherapy that have our key focus right now.
Speaker #6: But as David also discussed, the combinations now starting with CD388 is also carrying investments as we progress these programs. And we would hope to see more combinations really utilizing petrolentide's potential as the foundational therapy but perhaps, David, you can comment a little bit more on the phase 3 considerations and why we have strong belief that it can become a foundational therapy.
Speaker #11: Yeah. Thanks, Adam, and thanks, Kirsty. As noted, the phase 3B program, beyond rapid acceleration of the phase 3A program to ensure the earliest possible submission and potential approval, you can imagine that it is obviously, the outcomes that matter most to patients and their providers that will be the focus not only of the weight loss studies in phase 3A but focusing on those complications which we know are readily tied to weight reduction, such as obstructive sleep apnea, osteoarthritis, and osteoarthritis pain.
Adam Steensberg: Of course, when you launch with a new category, which may provide a much more pleasant weight loss experience, there will be novel dynamics also with regard to pricing. So while the GLP-1 dynamics will affect entrants into that market, we do anticipate that novel themes will play out, when you launch novel categories, just as we have seen in other therapeutic areas. So, but it's too early to provide any specifics on the net pricing, when we launch the triöse. Thank you, Osman.
Adam Steensberg: Of course, when you launch with a new category, which may provide a much more pleasant weight loss experience, there will be novel dynamics also with regard to pricing. So while the GLP-1 dynamics will affect entrants into that market, we do anticipate that novel themes will play out, when you launch novel categories, just as we have seen in other therapeutic areas. So, but it's too early to provide any specifics on the net pricing, when we launch the triöse. Thank you, Osman.
David Kendall: Thank you.
Adam Lange: Thank you.
Operator: Thank you. We will take our next question. The next question comes from the line of Kirsty Rothstewart from BNP Paribas. Please go ahead. Your line is open.
Operator: Thank you. We will take our next question. The next question comes from the line of Kirsty Ross-stewart from BNP Paribas. Please go ahead. Your line is open.
Speaker #11: Noting that amyloid agonists may have the unique potential to favorably alter bone metabolism and impact pain markers, as has already been shown for the GLP-1 agonist, reduced weight has its benefits, and we are going beyond that.
Kirsty Ross-Stewart: Hi. Yes, Kirsty Rothstewart from BNP Paribas. Thanks for taking my question. So regarding the phase 3b development for survodutide, can you just expand a little bit on the types of opportunities you're hoping to unlock with the broader clinical trial program? And how much of the total opportunity do you believe is represented by the monotherapy? Is that kind of the majority part? Is that what we should be thinking as the main part, or, or just, you know, you're seeing this as a small portion and just the tip of the iceberg? And just related to that, can you remind us on the financial obligations from you and Roche regarding the future phase 3b development? Thank you.
Kirsty Ross-Stewart: Hi. Yes, Kirsty Ross-stewart from BNP Paribas. Thanks for taking my question. So regarding the phase 3b development for survodutide, can you just expand a little bit on the types of opportunities you're hoping to unlock with the broader clinical trial program? And how much of the total opportunity do you believe is represented by the monotherapy? Is that kind of the majority part? Is that what we should be thinking as the main part, or, or just, you know, you're seeing this as a small portion and just the tip of the iceberg? And just related to that, can you remind us on the financial obligations from you and Roche regarding the future phase 3b development? Thank you.
Speaker #11: But beyond those, I think attention to preserving muscle mass, maintaining functional status, focusing on the population that seeks weight-reducing therapies the most, specifically women, and women's health implications, and finally, very important impact of those coexistent comorbid conditions: cardiovascular outcomes being primary, looking at the impact on liver disease and other metabolic dysfunction associated comorbidities.
Adam Steensberg: Thank you for your question. I'll just start with a few remarks and then hand over to David. As you know, the focus for the team right now is to accelerate timelines to a potential launch of the triöse, and in parallel, invest deeply in making sure that the triöse will become a foundational and first choice therapy, and thus, also having the data foundation to support that positioning. We will share all costs with our partner, us, in those efforts. It's clearly the monotherapy that has our key focus right now, but as David also discussed, the combinations now starting with CT-388, is also carrying investments as we progress these programs. We would hope to see more combinations really utilizing the triöse potentially as a foundational therapy.
Adam Steensberg: Thank you for your question. I'll just start with a few remarks and then hand over to David. As you know, the focus for the team right now is to accelerate timelines to a potential launch of the triöse, and in parallel, invest deeply in making sure that the triöse will become a foundational and first choice therapy, and thus, also having the data foundation to support that positioning. We will share all costs with our partner, us, in those efforts. It's clearly the monotherapy that has our key focus right now, but as David also discussed, the combinations now starting with CT-388, is also carrying investments as we progress these programs. We would hope to see more combinations really utilizing the triöse potentially as a foundational therapy.
Speaker #11: As Adam noted, the focus initially is on monotherapy, establishing amyloid-based therapies and petrolentide in particular as a foundational therapy. But understanding that in complex metabolic diseases such as lipid disorders, hypertension, type 2 diabetes, we have learned that the complexity of these diseases often requires multifaceted approaches to therapy.
Speaker #11: So, combinations with incretin-based therapies and other modalities, as being investigated by us and others, we believe will become the cornerstone of the optimal treatment for obesity and its related conditions.
Adam Steensberg: But perhaps, David, you can comment a little bit more on the phase 3 considerations and foundational, and why we have strong belief that it can become a foundational therapy.
Adam Steensberg: But perhaps, David, you can comment a little bit more on the phase 3 considerations and foundational, and why we have strong belief that it can become a foundational therapy.
Speaker #11: To re-emphasize what Adam stated, petrolentide as monotherapy, which we firmly believe can be foundational but also substantially improve the patient experience, will be the focus of phase 3A with the extension in phase 3B to unlock the full potential of this asset.
David Kendall: Yeah. Thanks, Adam, and thanks, Kirsty. As noted, the phase 3B program beyond a rapid acceleration of the phase 3A program to ensure the earliest possible submission and potential approval, you can imagine that it is... Obviously, the outcomes that matter most to patients and their providers that will be the focus not only of the weight loss studies in phase 3A, but focusing on those complications which we know are readily tied to weight reduction, such as obstructive sleep apnea, osteoarthritis, and osteoarthritis pain. Noting that amylin agonists may have the unique potential to favorably alter bone metabolism and impact pain markers, as has already been shown for the GLP-1 agonist, reduced weight has its benefits, and going beyond that.
David Kendall: Yeah. Thanks, Adam, and thanks, Kirsty. As noted, the phase 3B program beyond a rapid acceleration of the phase 3A program to ensure the earliest possible submission and potential approval, you can imagine that it is... Obviously, the outcomes that matter most to patients and their providers that will be the focus not only of the weight loss studies in phase 3A, but focusing on those complications which we know are readily tied to weight reduction, such as obstructive sleep apnea, osteoarthritis, and osteoarthritis pain. Noting that amylin agonists may have the unique potential to favorably alter bone metabolism and impact pain markers, as has already been shown for the GLP-1 agonist, reduced weight has its benefits, and going beyond that.
Speaker #6: And just maybe a comment from me, Kirsty, as well on the financial obligations. So yes, we will share costs both on phase 3A but also phase 3B 50/50 with Raj.
Speaker #6: As I mentioned in my remarks, we will receive 575 million in connection with the phase 3 initiation. And we will also receive 575 million US dollars in connection with phase 3B initiation from Raj.
Speaker #10: Thanks very much.
Speaker #7: Thank you. We will take our next question. Your next question comes from the line of Andy Shee from William Blair. Please go ahead. Your line is open.
Speaker #12: Thanks for taking our questions and congratulations on a stellar 2025. Adam, I appreciate that you're moving the field away from the weight loss Olympics as you coined the phrase.
David Kendall: But beyond those, I think, attention to preserving muscle mass, maintaining functional status, focusing on the population that seeks weight-reducing therapies the most, specifically women and women's health implications. And finally, a very important impact of those co-existing comorbid conditions, cardiovascular outcomes being primary, looking at the impact on liver disease and other metabolic dysfunction-associated comorbidities. As Adam noted, the focus initially is on monotherapy, establishing amylin-based therapies, and survodutide in particular, as a foundational therapy. But understanding that in complex metabolic diseases such as lipid disorders, hypertension, type 2 diabetes, we have learned that the complexity of these diseases often requires multifaceted approaches to therapy.
David Kendall: But beyond those, I think, attention to preserving muscle mass, maintaining functional status, focusing on the population that seeks weight-reducing therapies the most, specifically women and women's health implications. And finally, a very important impact of those co-existing comorbid conditions, cardiovascular outcomes being primary, looking at the impact on liver disease and other metabolic dysfunction-associated comorbidities. As Adam noted, the focus initially is on monotherapy, establishing amylin-based therapies, and survodutide in particular, as a foundational therapy. But understanding that in complex metabolic diseases such as lipid disorders, hypertension, type 2 diabetes, we have learned that the complexity of these diseases often requires multifaceted approaches to therapy.
Speaker #12: Just to gauge expectations for Supreme One, semaglutide and tirzepatide showed an additional 2 and 3 percent weight loss from 42 weeks to steady end.
Speaker #12: So objectively, should we subtract that 2 to 3 percent from your TPP goal just to account for the timing difference and gender mix for the imminent readout?
Speaker #12: And also, if you don't mind, maybe a macro question on what Lilly has done recently. They wanted to re-categorize decapitide as a biologic. So if they're successful, do you think that that might set a precedent for all the peptides out there, including petrolentide?
Speaker #12: Thank you so much.
Speaker #6: Thank you for your question. And I would say when you and of course, everybody compares across studies when we have designed our Supreme One study, we have had one key focus, and that is to generate the most robust data set to allow us for the most robust decision-making to move into phase 3.
David Kendall: Combinations with incretin-based therapies and other modalities, as being investigated by us and others, we believe will become the cornerstone of the optimal treatment for obesity and its related conditions. To reemphasize what Adam stated, survodutide as monotherapy, which we firmly believe can be foundational but also substantially improve the patient experience, will be the focus of phase 3A, with the extension in phase 3B to unlock the full potential of this asset.
David Kendall: Combinations with incretin-based therapies and other modalities, as being investigated by us and others, we believe will become the cornerstone of the optimal treatment for obesity and its related conditions. To reemphasize what Adam stated, survodutide as monotherapy, which we firmly believe can be foundational but also substantially improve the patient experience, will be the focus of phase 3A, with the extension in phase 3B to unlock the full potential of this asset.
Speaker #6: So we have not enhanced the study with a disproportionately high amount of women or high BMI. And we have also decided to look at the data point of week 42 instead of week 48, as others would do, to also have the most robust data set for Phase 3 decisions.
Speaker #6: So when we then as David also shared in his prepared remarks, think about what are the weight loss that we anticipate to see and that we would expect in that study under these study conditions that translate into a 15 to 20 percent weight loss.
[Company Representative] (Zealand Pharma): Just maybe a comment from me, Kirsty, as well, on the financial obligation. Yes, we will share costs both on Phase 3A but also Phase 3B, 50/50 with Roche.
[Company Representative] (Zealand Pharma): Just maybe a comment from me, Kirsty, as well, on the financial obligation. Yes, we will share costs both on Phase 3A but also Phase 3B, 50/50 with Roche.
Speaker #6: In a phase 3 study setup, that's how we will look at the data. And I would say historically, when you look into male-to-female ratio, if you take a study that is enriched with only females versus males, you could probably expect what 5 percent more weight loss in the female-only cohort.
Adam Steensberg: ... As I mentioned in my remarks, we will receive $575 million in connection with the phase 3 initiation, and we will also receive $575 million in connection with phase 3B initiation from Roche.
Adam Steensberg: ... As I mentioned in my remarks, we will receive $575 million in connection with the phase 3 initiation, and we will also receive $575 million in connection with phase 3B initiation from Roche.
Speaker #6: If you then also enhance the BMI and the study duration, then you would see even higher differences. So we are looking for a data set that, when we do our internal modeling, will allow us to get this 15 to 20 percent weight loss.
Yihan Li: Thanks very much.
Kirsty Ross-Stewart: Thanks very much.
Operator: Thank you. We will take our next question. Your next question comes from the line of Andy Shee from William Blair. Please go ahead. Your line is open.
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.
Speaker #6: And the reason that we have called to end the weight loss Olympics is just the plain fact that patients are not interested most patients are not interested in a weight loss above 20 percent.
Andy Hsieh: Thanks for taking our questions, and congratulations on the stellar 2025. Adam, I appreciate that you're moving the field away from the weight loss Olympics, as you coined the phrase. Just to gauge expectations for ZUPREME-1, semaglutide and tirzepatide showed an additional 2 and 3% weight loss from 42 weeks to study end. So objectively, should we subtract that 2 to 3% from your TPP goal, just to account for the timing difference and gender mix for the imminent readout? And also, if you don't mind, maybe a macro question on what Lilly has done recently. They wanted to recategorize retatrutide as a biologic. So if they're successful, do you think that that might set a precedent for all the peptides out there, including setmelanotide? Thank you so much.
Andy Hsieh: Thanks for taking our questions, and congratulations on the stellar 2025. Adam, I appreciate that you're moving the field away from the weight loss Olympics, as you coined the phrase. Just to gauge expectations for ZUPREME-1, semaglutide and tirzepatide showed an additional 2 and 3% weight loss from 42 weeks to study end. So objectively, should we subtract that 2 to 3% from your TPP goal, just to account for the timing difference and gender mix for the imminent readout? And also, if you don't mind, maybe a macro question on what Lilly has done recently. They wanted to recategorize retatrutide as a biologic. So if they're successful, do you think that that might set a precedent for all the peptides out there, including setmelanotide? Thank you so much.
Speaker #6: So why is it that we as an industry and a community keep talking about those numbers as if they were so important? You can do these surveys among patients, and you will get the same answer across any survey that we have seen thus far.
Speaker #6: And that's why I called for the end. As I also said, and as we discussed also in one of the prior questions, the key to unlock the value in this market is to develop therapies that provide patients with the weight loss they are looking for, and, as importantly, therapies that they can stay on—instead of therapies where they only take them for three to six months and then stop taking them.
Speaker #6: The big dilemma we have with people who don't stay on therapy is that most will likely regain the weight and thus never get to the health benefits.
Adam Steensberg: Thank you for your question, Andy, and I would say, when you and of course, everybody compares across the studies. When we have designed our ZUPREME-1 study, we have had one key focus, and that is to generate the most robust data set, to allow us for the most robust decision making to move into phase 3. So we have not enhanced the study with a disproportional high amount of women or high BMI, and we've also decided to look at the data point of week 42 instead of week 48, as others would do, and also have the most robust data set for phase 3 decisions.
Adam Steensberg: Thank you for your question, Andy, and I would say, when you and of course, everybody compares across the studies. When we have designed our ZUPREME-1 study, we have had one key focus, and that is to generate the most robust data set, to allow us for the most robust decision making to move into phase 3. So we have not enhanced the study with a disproportional high amount of women or high BMI, and we've also decided to look at the data point of week 42 instead of week 48, as others would do, and also have the most robust data set for phase 3 decisions.
Speaker #6: So both from a patient and a society perspective, but also from a company value perspective, the focus has to be on treatments that deliver the weight loss that most patients are looking for—15% to 20%—and then, importantly, medicines they can stay on.
Speaker #6: And that's why I'm calling to end the weight loss Olympics. Focus on medicines that deliver what the patients want, and you will unlock the value in this market.
Speaker #6: On your other question, with regard to Lilly's efforts to move from a small molecule designation to a biologic, I'm sure that industry is looking into different ways to enhance, you can say, the positioning of their drugs.
Adam Steensberg: So when we then, as David also shared in his prepared remarks, think about what the weight loss that we anticipate to see and that we would expect in that study under these study conditions, that translates into a 15 to 20% weight loss in a phase 3 study setup. That's how we will look at the data. And I would say historically, when you look into male to female ratio, if you take a study that is enriched with only females versus males, you could probably expect, what, 5% more weight loss in the female-only cohort. If you then also enhance the BMI and the study duration, then you will see even higher differences.
Adam Steensberg: So when we then, as David also shared in his prepared remarks, think about what the weight loss that we anticipate to see and that we would expect in that study under these study conditions, that translates into a 15 to 20% weight loss in a phase 3 study setup. That's how we will look at the data. And I would say historically, when you look into male to female ratio, if you take a study that is enriched with only females versus males, you could probably expect, what, 5% more weight loss in the female-only cohort. If you then also enhance the BMI and the study duration, then you will see even higher differences.
Speaker #6: And I will not share our specific efforts to protect the value of our programs, but rest assured that we also have those efforts as a key focus.
Speaker #6: Thank you, Adam.
Speaker #12: Thank you.
Speaker #7: Thank you. We will take our next question. Your next question comes from the line of Yee Han Lee from Barclays. Please go ahead. Your line is open.
Speaker #13: Hey, Yee Han from Barclays. Thanks for taking our question. So I guess I wanted to switch gears a little bit to SGLT over the tide and also MESh.
Adam Steensberg: So, we are looking for a data set that when we do our internal modeling work, allow us to get this 15 to 20% weight loss. And the reason that we have called to end the weight loss Olympics is just the plain fact that patients are not interested. Most patients are not interested in a weight loss above 20%. So why is it that we, as an industry and a community, keeps talking about those numbers as if they were so important? You can do these surveys among patients, and you will get the same answer across any survey that we have seen thus far, and that's why I call for the end.
Adam Steensberg: So, we are looking for a data set that when we do our internal modeling work, allow us to get this 15 to 20% weight loss. And the reason that we have called to end the weight loss Olympics is just the plain fact that patients are not interested. Most patients are not interested in a weight loss above 20%. So why is it that we, as an industry and a community, keeps talking about those numbers as if they were so important? You can do these surveys among patients, and you will get the same answer across any survey that we have seen thus far, and that's why I call for the end.
Speaker #13: So for mesh, based on our recent KOL checks, I think the off-label use of increasing the mesh, but there's increasingly common for, for example, our physicians would still use tirzepatide and mesh if possible even though we know it is not formally approved by regulators.
Speaker #13: So I'm just curious, from your market research, are you observing something similar in terms of this physician behavior? And also, more broadly, assuming serve over the tide will be launched in 2027, and we understood we might be more optimist on this partnership, but also wondering anything you could share regarding its commercial strategy across obesity and mesh.
Adam Steensberg: As I also said, and as we discussed also in one of the prior questions, the key to unlock the value in this market is to develop therapies that provides patients with the weight loss they're looking for, and as importantly, therapies that they can stay on, instead of therapies where they only take them for three to six months and then stop taking them. The big dilemma we have with people don't stay on therapy is that most will likely regain the weight and thus never get to the health benefits. So both from a patient, a society perspective, but also from a company value perspective, the focus has to be on treatments that deliver the weight loss that the most patients are looking for, 15% to 20%, and then importantly, medicines they can stay on. And that's why I'm calling to end the weight loss Olympics.
Adam Steensberg: As I also said, and as we discussed also in one of the prior questions, the key to unlock the value in this market is to develop therapies that provides patients with the weight loss they're looking for, and as importantly, therapies that they can stay on, instead of therapies where they only take them for three to six months and then stop taking them. The big dilemma we have with people don't stay on therapy is that most will likely regain the weight and thus never get to the health benefits. So both from a patient, a society perspective, but also from a company value perspective, the focus has to be on treatments that deliver the weight loss that the most patients are looking for, 15% to 20%, and then importantly, medicines they can stay on. And that's why I'm calling to end the weight loss Olympics.
Speaker #13: Thank you so much.
Speaker #6: Thank you for your question. And it's important to note that it is during Engelheim, who is solely responsible for the development and the commercialization of serve over the tide, we will just get milestones and then high single to low double-digit royalties.
Speaker #6: The profile that we have seen thus far from the clinical data released by Boehringer for serve over the tide gives us a lot of confidence in the molecule, both with regard to weight loss, but also in mesh.
Speaker #6: On the weight loss parameters, as we have discussed before, we think the weight loss levels and the weight loss experience is going to be quite comparable to what we have seen with some of the market-leading GLP-1s on the market today, we look forward to seeing the phase 3 data.
Adam Steensberg: Focus on medicines that deliver what the patients want, and you will unlock the value in this market. On your other question, with regard to Lilly's efforts to move from a small molecule designation to a biologic, I'm sure that industry is looking into different ways to enhance, you can say, the positioning of their drugs. And I will not share our specific efforts to protect the value of our programs. But rest assured that we also have those efforts as key focus. Thank you, Andy.
Adam Steensberg: Focus on medicines that deliver what the patients want, and you will unlock the value in this market. On your other question, with regard to Lilly's efforts to move from a small molecule designation to a biologic, I'm sure that industry is looking into different ways to enhance, you can say, the positioning of their drugs. And I will not share our specific efforts to protect the value of our programs. But rest assured that we also have those efforts as key focus. Thank you, Andy.
Speaker #6: When it comes to the MESH data, the Phase 2 MESH data that we have seen—and it's also expressed by Boehringer at the time when the data was released—we see them as breakthrough data.
Speaker #6: These are unprecedented levels of improvements. And I think that's also reflected in the fact that Boehringer have decided to invest in the largest ever phase 3 program for mesh, not only addressing F2 and F3, but also F4 patients.
Speaker #6: Which gives unique opportunities to broaden the potential label if approved beyond into the most severe cases of mesh, but also with the scope of the program could provide very early indications of clinical and not just biomarker improvements.
Andy Hsieh: Thank you.
Andy Hsieh: Thank you.
Operator: Thank you. We will take our next question. Your next question comes from the line of Yihan Li from Barclays. Please go ahead, your line is open.
Operator: Thank you. We will take our next question. Your next question comes from the line of Yihan Li from Barclays. Please go ahead, your line is open.
Yihan Li: Hey, Yihan from Barclays. Thanks for taking our question. So I guess I wanted to switch gear a little bit to survodutide and also MASH. So for MASH, based on our recent KL checks, actually, the off-label use of increasing MASH appears increasingly common. So, for example, our physicians would still use tirzepatide and MASH if possible, even though we know it is not formally approved by regulators. So I'm just curious, from your market research, are you observing something similar in terms of this physician behavior? And also more broadly, like assuming survodutide will be launched in 2027, and we understood you might be more open on this partnership, but also wondering, you know, anything you would share regarding its commercial strategy across obesity and MASH. Thank you so much.
Yihan Li: Hey, Yihan from Barclays. Thanks for taking our question. So I guess I wanted to switch gear a little bit to survodutide and also MASH. So for MASH, based on our recent KL checks, actually, the off-label use of increasing MASH appears increasingly common. So, for example, our physicians would still use tirzepatide and MASH if possible, even though we know it is not formally approved by regulators. So I'm just curious, from your market research, are you observing something similar in terms of this physician behavior? And also more broadly, like assuming survodutide will be launched in 2027, and we understood you might be more open on this partnership, but also wondering, you know, anything you would share regarding its commercial strategy across obesity and MASH. Thank you so much.
Speaker #6: With regard to what you mentioned as off-label use, if I heard you right, of the GLP-1s, I would say please remember that the majority of mesh patients are obese in the first place, and thus of course, it's a logical choice to use the existing medicines to help patients achieve some weight loss as many mesh patients suffer from both obesity and other complications than mesh so that is only a natural consequence.
Speaker #6: What we believe is that once you have a product that can make a significant larger effect on the disease status we should expect to see a very attractive take-up.
Speaker #6: Also, exemplified by the enrollment into the phase 3 program and phase 2 program for serve over the tide. So we have a high confidence in the program.
Speaker #6: We have a high confidence in Boehringer's ability to execute. They are one of the strongest large pharma players in the cardiovascular metabolic space, and we look forward to see the data coming out this year, including the cardiovascular outcome data and obesity.
Adam Steensberg: Thank you for your question. And, you know, it's important to note that it is Boehringer Ingelheim who is solely responsible for the development and the commercialization of survodutide. We will just get milestones and then high single- to low double-digit royalties. The profile that we have seen thus far from the clinical data released by Boehringer for survodutide gives us a lot of confidence in the molecule, both with regard to weight loss, but also in MASH. On the weight loss parameters, as we have discussed before, we think the weight loss levels and the weight loss experience is gonna be quite comparable to what we have seen with some of the market-leading tier ones on the market today. We look forward to seeing the Phase 3 data.
Adam Steensberg: Thank you for your question. And, you know, it's important to note that it is Boehringer Ingelheim who is solely responsible for the development and the commercialization of survodutide. We will just get milestones and then high single- to low double-digit royalties. The profile that we have seen thus far from the clinical data released by Boehringer for survodutide gives us a lot of confidence in the molecule, both with regard to weight loss, but also in MASH. On the weight loss parameters, as we have discussed before, we think the weight loss levels and the weight loss experience is gonna be quite comparable to what we have seen with some of the market-leading tier ones on the market today. We look forward to seeing the Phase 3 data.
Speaker #13: Very helpful. Thank you.
Speaker #6: Thank you.
Speaker #7: Thank you. We will take our next question. The question comes from Zion Deng from UBS. Please go ahead. Your line is open.
Speaker #13: Hi. It's him from UBS. Thank you for taking my question. So two, please. The first one is on Supreme One. So really appreciate you emphasized reiterated the importance of tolerability.
Speaker #13: So just wondering, looking into Supreme One, just wondering what sort of profiles do you act would you actually consider as really your target profiles in terms of tolerability?
Adam Steensberg: When it comes to the MASH data, the phase 2 MASH data that we have seen, and it's also expressed by Boehringer at the time when the data was released, we see them as breakthrough data. These are unprecedented levels of improvements, and I think that's also reflected in the fact that Boehringer have decided to invest in the largest ever phase 3 program for MASH. Not only addressing F2 and F3, but also F4 patients, which gives unique opportunities to broaden the potential label, if approved, beyond into the most severe cases of MASH. But also, with the scope of the program, could provide very early indications of clinical, and not just biomarker improvements.
Adam Steensberg: When it comes to the MASH data, the phase 2 MASH data that we have seen, and it's also expressed by Boehringer at the time when the data was released, we see them as breakthrough data. These are unprecedented levels of improvements, and I think that's also reflected in the fact that Boehringer have decided to invest in the largest ever phase 3 program for MASH. Not only addressing F2 and F3, but also F4 patients, which gives unique opportunities to broaden the potential label, if approved, beyond into the most severe cases of MASH. But also, with the scope of the program, could provide very early indications of clinical, and not just biomarker improvements.
Speaker #13: Would you say, let's say, do you think it's actually possible to achieve, let's say, placebo-level similar to placebo-level or vomiting and constipation? So any color on that, that would be great.
Speaker #13: So the second one is sort of a general question. So a few days ago, so Eli Lilly showed some quite interesting data combining tirzepatide and TALT in psoriasis, which actually showed better skin clearance than TALT alone.
Speaker #13: Of course, that's in psoriasis patients that are also obese. But just wondering if you have any thoughts on that, and would you consider for example, in the future collaborating with some other autoimmune players on something similar as well?
Adam Steensberg: With regard to what you mentioned as, as off-label use, if I heard you right, of the tier ones, I would say, please remember that the majority of MASH patients are obese, in the first place. And thus, of course, it's a logical choice to use the existing medicines to help patients achieve some weight loss, as many MASH patients suffer from both obesity and other complications than MASH. So that is only a natural consequence. What we believe is that once you have a product that can make a significant larger effect on the disease stages, we should expect to see a very attractive take-up. Also exemplified by the enrollment into the phase 3 program and phase 2 program for survodutide. So we have a high confidence in the program. We have a high confidence in Boehringer's ability to execute.
Adam Steensberg: With regard to what you mentioned as, as off-label use, if I heard you right, of the tier ones, I would say, please remember that the majority of MASH patients are obese, in the first place. And thus, of course, it's a logical choice to use the existing medicines to help patients achieve some weight loss, as many MASH patients suffer from both obesity and other complications than MASH. So that is only a natural consequence. What we believe is that once you have a product that can make a significant larger effect on the disease stages, we should expect to see a very attractive take-up. Also exemplified by the enrollment into the phase 3 program and phase 2 program for survodutide. So we have a high confidence in the program. We have a high confidence in Boehringer's ability to execute.
Speaker #13: Thank you.
Speaker #6: Thank you for your question. I'll just start by putting some thoughts on your second question and then hand over to David to follow up and also address your first question.
Speaker #6: I think maybe also saw that yesterday we also announced a phase 1 data readout with our KB1.3 ion channel blocker, which is a broad autoimmune anti-inflammatory target, which has potential across a number of inflammatory conditions and thus we see that as a potential pipeline in a product.
Speaker #6: And there's another notion out there that, in relation to the obesity pandemic, you actually see quite significant increases in the prevalence of some chronic autoimmune and inflammatory conditions, which had otherwise been seen as being rather stable.
Speaker #6: So we see a strong link between the obesity pandemic and the rising prevalence of some of these conditions. And it's clear that if you name things like psoriasis or even IBD, there are some strong links with the obesity pandemic.
Adam Steensberg: They are one of the strongest largest pharma players in the cardiovascular, metabolic space, and we look forward to see the data coming out this year, including the cardiovascular outcome data and obesity.
Adam Steensberg: They are one of the strongest largest pharma players in the cardiovascular, metabolic space, and we look forward to see the data coming out this year, including the cardiovascular outcome data and obesity.
Operator: Very helpful. Thank you.
Yihan Li: Very helpful. Thank you.
Speaker #6: So we are highly energized by our own KB1.3 data and the opportunity to perhaps link metabolism and inflammation in the future. But David, maybe you want to elaborate.
Adam Steensberg: Thank you.
Adam Steensberg: Thank you.
Operator: Thank you. We will take our next question. The question comes from Xian Deng from UBS. Please go ahead. Your line is open.
Operator: Thank you. We will take our next question. The question comes from Xian Deng from UBS. Please go ahead. Your line is open.
Xian Deng: Hi, it's Xian from UBS. Thank you for taking my question. So, two, please. The first one is on ZUPREME-1. So, really appreciate you emphasized, you know, reiterated the importance of tolerability. So, just wondering, looking into ZUPREME-1, just wondering, what sort of profile would you actually consider as really, you know, your target profile in terms of tolerability? Would you say... Let's say, do you think it's actually possible to achieve, let's say, placebo level, you know, similar to placebo level of vomiting and constipation? So, any color on that, that would be great. So, the second one is, sort of a general question. So, a few days ago, so, Eli Lilly showed some quite interesting data combining tirzepatide and Taltz in psoriasis, which actually showed better skin clearance than Taltz alone.
Xian Deng: Hi, it's Xian from UBS. Thank you for taking my question. So, two, please. The first one is on ZUPREME-1. So, really appreciate you emphasized, you know, reiterated the importance of tolerability. So, just wondering, looking into ZUPREME-1, just wondering, what sort of profile would you actually consider as really, you know, your target profile in terms of tolerability? Would you say... Let's say, do you think it's actually possible to achieve, let's say, placebo level, you know, similar to placebo level of vomiting and constipation? So, any color on that, that would be great. So, the second one is, sort of a general question. So, a few days ago, so, Eli Lilly showed some quite interesting data combining tirzepatide and Taltz in psoriasis, which actually showed better skin clearance than Taltz alone.
Speaker #5: Yeah. And again, thanks for your questions on the issue of tolerability noting that tolerability is really a collection of factors we focus obviously a great deal on the GI adverse events that have been made so central, particularly to incretin-based therapies.
Speaker #5: And while our phase 1 data to date have suggested the potential for significantly lower rates of nausea, vomiting, and certainly lower rates of the more chronic GI adverse events associated with GLP-1-based therapies, namely diarrhea and constipation, in Supreme One and subsequent trials, tolerability and acceptability of the entire experience will be the focus of our evaluation.
Xian Deng: Of course, that's in psoriasis patients, you know, that are also obese, but just wondering if you have any thoughts on that, and would you consider, for example, in the future, collaborating with some other autoimmune players on something similar as well? Thank you.
Xian Deng: Of course, that's in psoriasis patients, you know, that are also obese, but just wondering if you have any thoughts on that, and would you consider, for example, in the future, collaborating with some other autoimmune players on something similar as well? Thank you.
Speaker #5: So looking obviously at GI adverse events, but in combination with the injection experience, the experience around dosing and dose escalation, and back to the question that was posed to Adam on orals versus injectables, if one thinks about the currently available therapies and the target product profile for patralentide, we anticipate that the weekly injection will consume about 10 to 20 seconds of an individual patient's time, which clearly can be associated with the acceptability of a treatment, assuming that injection experience is without reactions, pain, discomfort, which we have seen in our phase 1 trials to date.
Adam Steensberg: Thank you for your question. I'll just start by putting some thoughts on your second question and then hand over to David to follow up and also address your first question. I think maybe you also saw that yesterday, we also announced a phase 1 data readout with our Kv1.3 ion channel blocker, which is a broad autoimmune anti-inflammatory target, which has potential across a number of inflammatory conditions. And thus, we see that as a potential pipeline in a product. And there's another notion out there that in relation to the obesity pandemic, you actually see quite significant increases in the prevalence of some chronic autoimmune and inflammatory conditions, which had otherwise been seen as being rather stable.
Adam Steensberg: Thank you for your question. I'll just start by putting some thoughts on your second question and then hand over to David to follow up and also address your first question. I think maybe you also saw that yesterday, we also announced a phase 1 data readout with our Kv1.3 ion channel blocker, which is a broad autoimmune anti-inflammatory target, which has potential across a number of inflammatory conditions. And thus, we see that as a potential pipeline in a product. And there's another notion out there that in relation to the obesity pandemic, you actually see quite significant increases in the prevalence of some chronic autoimmune and inflammatory conditions, which had otherwise been seen as being rather stable.
Speaker #5: So I encourage you and others, as we will be doing, to look at tolerability and acceptability as a collection of these factors—GI adverse events and more—and to Adam's ultimate point, if that experience is highly acceptable to patients, that will further encourage long-term persistence on therapies, and particularly therapies that give patients the weight loss they desire.
Adam Steensberg: So we see a strong link between the obesity pandemic and the rising prevalence of some of these conditions. And it's clear that if you may name things like psoriasis or even IBD, there are some strong links with the obesity pandemic. So we are highly energized by our own Kv1.3 data and the opportunity to perhaps link metabolism and inflammation in the future. But David, maybe you wanna elaborate.
Adam Steensberg: So we see a strong link between the obesity pandemic and the rising prevalence of some of these conditions. And it's clear that if you may name things like psoriasis or even IBD, there are some strong links with the obesity pandemic. So we are highly energized by our own Kv1.3 data and the opportunity to perhaps link metabolism and inflammation in the future. But David, maybe you wanna elaborate.
Speaker #6: Thank you.
Speaker #7: Thank you. We will take our next question. The question comes from the line of Jen here from Cantor Fitzgerald. Please go ahead, your line is open.
Speaker #8: Hi. This is Jennifer Gia on behalf of Prakhar Agarwal from Cantor Fitzgerald. Thank you for taking my questions. So I was wondering for the upcoming phase 2B obesity readout for patralentide, in what way can it differentiate on safety, tolerability versus Lilly's Amlin and Loralentide?
David Kendall: Mm-hmm. Yeah, and again, thanks for your questions. On the issue of tolerability, noting that tolerability is really a collection of factors, we focus obviously a great deal on the GI adverse events that have been made so central, particularly to incretin-based therapies. And while our Phase 1 data to date have suggested the potential for significantly lower rates of nausea, vomiting, and certainly lower rates of the more chronic GI adverse events associated with GLP-1-based therapies, namely diarrhea and constipation. In ZUPREME-1 and subsequent trials, tolerability and acceptability of the entire experience will be the focus of our evaluation. So looking obviously at GI adverse events, but in combination with the injection experience, the experience around dosing and dose escalation.
David Kendall: Mm-hmm. Yeah, and again, thanks for your questions. On the issue of tolerability, noting that tolerability is really a collection of factors, we focus obviously a great deal on the GI adverse events that have been made so central, particularly to incretin-based therapies. And while our Phase 1 data to date have suggested the potential for significantly lower rates of nausea, vomiting, and certainly lower rates of the more chronic GI adverse events associated with GLP-1-based therapies, namely diarrhea and constipation. In ZUPREME-1 and subsequent trials, tolerability and acceptability of the entire experience will be the focus of our evaluation. So looking obviously at GI adverse events, but in combination with the injection experience, the experience around dosing and dose escalation.
Speaker #8: And also for the combo with patralentide with CT388. Could you give more context on dosing across the two products, titration schedule, as well as how you want to mitigate the GI talks?
Speaker #8: Previously seen with CT388. Thank you.
Speaker #6: Yeah. Thank you for that question. It's as we have tried to convey on this call that most important aspect for us when we review these data is to confirm that we have a product that lives up to the target product profile, which we have discussed a number of times, which is delivering a 15 to 20 percent weight loss and a more pleasant weight loss experience.
Speaker #6: If we have that, we will have a leading category leading molecule within the new category. And I think it's really, really important to also look back at the data that have been generated thus far with patralentide, which gives us the confidence when we look across the different amidin assets, we have what looks to be the best-in-class amidin analog in development.
David Kendall: And back to the question that was posed to Adam on orals versus injectables. If one thinks about the currently available therapies and the target product profile for petrelintide, we anticipate that the weekly injection will consume about 10 to 20 seconds of an individual patient's time, which clearly can be associated with the acceptability of a treatment, assuming that injection experience is without reactions, pain, discomfort, which we have seen in our phase 1 trials to date. So I encourage you and others, as we will be doing, to look at tolerability and acceptability as a collection of these factors, GI adverse events and more. And to Adam's ultimate point, if that experience is highly acceptable to patients, that will further encourage long-term persistence on therapies, and particularly therapies that give patients the weight loss they desire.
David Kendall: And back to the question that was posed to Adam on orals versus injectables. If one thinks about the currently available therapies and the target product profile for petrelintide, we anticipate that the weekly injection will consume about 10 to 20 seconds of an individual patient's time, which clearly can be associated with the acceptability of a treatment, assuming that injection experience is without reactions, pain, discomfort, which we have seen in our phase 1 trials to date. So I encourage you and others, as we will be doing, to look at tolerability and acceptability as a collection of these factors, GI adverse events and more. And to Adam's ultimate point, if that experience is highly acceptable to patients, that will further encourage long-term persistence on therapies, and particularly therapies that give patients the weight loss they desire.
Speaker #6: And that's why we move towards the phase 2 data with a high level of confidence, both with regard to weight loss and tolerability data.
Speaker #6: But the most important part for us is to get confirmation in the phase 2 data with what we have seen in the phase 1 and thus that we are fully on the path to deliver on our target product profile.
Speaker #6: And thereby as we have also communicated several times, we think patralentide and amidin in general has the potential to be a larger category for weight management than the GLP-1s because if we allow patients to stay on therapy and you don't have to go out and capture new patients all the time, you would rapidly see the volumes of such a category outgrow the volumes of a category where people stop taking medicines early on.
Speaker #6: So this is the key focus for us when we look at the data. And we move forward based on the prior data experience, which I think we have released to the market.
Adam Steensberg: Thank you.
Adam Steensberg: Thank you.
Operator: Thank you. We will take our next question. The question comes from the line of Jennifer Jia from Cantor Fitzgerald. Please go ahead. Your line is open.
Operator: Thank you. We will take our next question. The question comes from the line of Jennifer Jia from Cantor Fitzgerald. Please go ahead. Your line is open.
Speaker #6: So we all have the opportunity to look at those data that patralentide has the potential to be the best-in-class amidin analog of those that are in the clinic today.
Prakhar Agrawal: Hi, this is Jennifer Jia, on behalf of Prakhar Agarwal from Cantor Fitzgerald. Thank you for taking my questions. So I was wondering, for the upcoming Phase 2b obesity readout for petrelintide, in what way can it differentiate on safety, tolerability versus Lilly's elorlintide, and also for the combo with petrelintide with CT-388? Could you give more context on dosing across the two products, titration schedule, as well as how you want to mitigate the GI tox previously seen with CT-388? Thank you.
Jennifer Jia: Hi, this is Jennifer Jia, on behalf of Prakhar Agarwal from Cantor Fitzgerald. Thank you for taking my questions. So I was wondering, for the upcoming Phase 2b obesity readout for petrelintide, in what way can it differentiate on safety, tolerability versus Lilly's elorlintide, and also for the combo with petrelintide with CT-388? Could you give more context on dosing across the two products, titration schedule, as well as how you want to mitigate the GI tox previously seen with CT-388? Thank you.
Speaker #6: The combination product, of course, is also a unique opportunity. And with CT388, when we did the diligence and the partnership with us, our conclusion was that CT388 looked to be potentially also a best-in-class GLP-1 DIP molecule and we look very much forward to seeing further data from that program.
Speaker #6: But the combination, when we think about the combination with that molecule, our gut feeling, if you will, would be to max out on the potential of patrelentide and then add a teaspoon of the GLP-1 component to enhance the weight loss experience for those patients who need the highest weight loss. And so, we look forward to sharing more on the study designs and, of course, ultimately the data that comes out of the Phase 2B study for the combination that we will start later this year.
Adam Steensberg: Yeah, thank you for that question. It's you know, as we have tried to convey on this call, the most important aspect for us when we review these data is to confirm that we have a product that lives up to the target product profile, which we have discussed a number of times, which is delivering a 15% to 20% weight loss and a more pleasant weight loss experience. If we have that, we will have a leading category, leading molecule within a new category. And I think it's really, really important to also look back at the data that has been generated thus far with petrelintide, which gives us the confidence when we look across the different amylin assets. We have what looks to be the best-in-class amylin analog in development.
Adam Steensberg: Yeah, thank you for that question. It's you know, as we have tried to convey on this call, the most important aspect for us when we review these data is to confirm that we have a product that lives up to the target product profile, which we have discussed a number of times, which is delivering a 15% to 20% weight loss and a more pleasant weight loss experience. If we have that, we will have a leading category, leading molecule within a new category. And I think it's really, really important to also look back at the data that has been generated thus far with petrelintide, which gives us the confidence when we look across the different amylin assets. We have what looks to be the best-in-class amylin analog in development.
Speaker #6: Thank you, Jennifer.
Speaker #7: Thank you. We will take our next question. The next question comes from the line of Kerry Holford from Berenberg. Please go ahead. Your line is open.
Speaker #9: Oh, thank you. A question from me, please, just on the planned phase 3A study design. I wonder if you can share any more detail on that.
Speaker #9: It's clear the message here is to expect you to accelerate launch and deal with the CBOT data later. But can you discuss the endpoint, the study time period that you're looking at for the phase 3A study?
Adam Steensberg: And that's why we move towards the Phase 2 data with a high level of confidence, both with regard to weight loss and tolerability, data. But the most important part for us is to get confirmation in this Phase 2 data with what we have seen in the Phase 1, and thus that we are fully on the path to deliver on our entire product profile. And thereby, as we have also communicated several times, we think petrelintide and amylin in general has the potential to be a larger category for weight management than the GLP-1. Because if you allow patients to stay on therapy and you don't have to go out and capture new patients all the time, you would rapidly see the volumes of such a category outgrow the volumes of a category where people stop taking medicines early on.
Adam Steensberg: And that's why we move towards the Phase 2 data with a high level of confidence, both with regard to weight loss and tolerability, data. But the most important part for us is to get confirmation in this Phase 2 data with what we have seen in the Phase 1, and thus that we are fully on the path to deliver on our entire product profile. And thereby, as we have also communicated several times, we think petrelintide and amylin in general has the potential to be a larger category for weight management than the GLP-1. Because if you allow patients to stay on therapy and you don't have to go out and capture new patients all the time, you would rapidly see the volumes of such a category outgrow the volumes of a category where people stop taking medicines early on.
Speaker #9: I mean, for example, could we see a scenario where six-month weight loss is sufficient to get a first approval for patralentide? Thank you.
Speaker #6: Thank you for your question. I think what we can reassure you is that we are together with us, we are doing everything possible to accelerate and we have some identified some very good levers and have a lot of confidence that we can accelerate and push this program as fast as possible forward.
Speaker #6: We cannot share the details also the exact details on submission timelines. Due to the fact that this is a partnership, so we need to agree on when to discuss these things.
Adam Steensberg: So this is the key focus for us when we look at the data and we move forward based on the prior data experience, which I think we have released to the market. So you all have the opportunity to look at those data, that petrelintide has the potential to be the best-in-class amylin, and of those that are in the clinic today. The combination product, of course, is also a unique opportunity. And with CT-388, when we did the diligence and the partnership with us, our conclusion was that CT-388 looked to be potentially also a best-in-class GLP-1/GIP molecule, and we look very much forward to seeing further data from that program.
Adam Steensberg: So this is the key focus for us when we look at the data and we move forward based on the prior data experience, which I think we have released to the market. So you all have the opportunity to look at those data, that petrelintide has the potential to be the best-in-class amylin, and of those that are in the clinic today. The combination product, of course, is also a unique opportunity. And with CT-388, when we did the diligence and the partnership with us, our conclusion was that CT-388 looked to be potentially also a best-in-class GLP-1/GIP molecule, and we look very much forward to seeing further data from that program.
Speaker #6: But we are all on in both organizations to make sure that things are being accelerated towards submission and ultimately a launch. What is also important here to note, and one of the main reasons that we decided to partner this program at the time we did, was, of course, investments into manufacturing capacity. We have been extremely pleased to see the announcements that Russell has come out with with regard to investments into high-volume, high-throughput manufacturing capacity, which, of course, is needed if you want to secure a successful launch when these products hit the market.
Adam Steensberg: But the combination, when we think about the combination with that molecule, our gut feeling, if you will, would be to max out on the potential of petrelintide and then add a teaspoon of the GLP-1 component to enhance the weight loss experience for those patients who need the highest weight loss. And so we look forward to share more on the study designs and of course, ultimately the data that comes out of the phase 2b study for the combination that we will start later this year. Thank you, Jennifer.
Adam Steensberg: But the combination, when we think about the combination with that molecule, our gut feeling, if you will, would be to max out on the potential of petrelintide and then add a teaspoon of the GLP-1 component to enhance the weight loss experience for those patients who need the highest weight loss. And so we look forward to share more on the study designs and of course, ultimately the data that comes out of the phase 2b study for the combination that we will start later this year. Thank you, Jennifer.
Speaker #6: And I think that's again coming back to the uniqueness of the partnership we have here and the uniqueness of Zealand today is that we are as I conveyed at our Capital Markets Day and we continue to operate as a biotech company.
Speaker #6: But we and that's the we will bring in the best from that world. But in the collaboration with us, we will also leverage the strength of the pharma company as we approach the market with patralentide.
Speaker #6: And I don't think you have seen many of these partnerships, but that is why we keep coming back to the strategic value and the and, of course, the profit share we have in this partnership is unique and it's one which we are extremely pleased with to see also how it progresses.
Operator: Thank you. We will take our next question. The next question comes from the line of Kerry Halford from Berenberg. Please go ahead. Your line is open.
Operator: Thank you. We will take our next question. The next question comes from the line of Kerry Halford from Berenberg. Please go ahead. Your line is open.
Speaker #6: We will hopefully soon be able to share more on the exact timelines as we move the program into Phase 3. But it's just, perhaps, one quarterly call too early.
Kerry Holford: Thank you. A question from me, please, just on the planned phase 3A study design. I wonder if you can share any more detail on that. It's clear the message here is to expect you to accelerate, launch, and deal with the CVOT data later. But can you discuss the endpoint, the study time period that you're looking at for the phase 3A study? I mean, for example, could we see a scenario where six months weight loss is sufficient to get a first approval for petrelintide? Thank you.
Kerry Holford: Thank you. A question from me, please, just on the planned phase 3A study design. I wonder if you can share any more detail on that. It's clear the message here is to expect you to accelerate, launch, and deal with the CVOT data later. But can you discuss the endpoint, the study time period that you're looking at for the phase 3A study? I mean, for example, could we see a scenario where six months weight loss is sufficient to get a first approval for petrelintide? Thank you.
Speaker #9: Thank you.
Speaker #7: Thank you. We will take our next question. The question comes from the line of Suzanne anne Van Woutersen from VLK. Please ask your question.
Speaker #10: Hi, team. This is Suzanne from Kempen. Thanks for taking my question. Looking beyond the Phase 2b readouts that we're all eagerly awaiting, and I believe how better could provide an alternative to incretins, and the product profile you're targeting is very clear.
Adam Steensberg: ... Thank you for your, for your question. I think what we can reassure you is that we are, together with us, we are doing everything possible to accelerate, and we have identified some very good levers and have a lot of confidence that we can accelerate and push this program as fast as possible forward. We cannot share the, the details, also the exact details on, on submission timeline, due to the fact that this is a partnership, so we need to agree on, on when to, to discuss these things. But we, we are all on in both organizations to make sure that things are being accelerated towards submission and ultimately, announced. What is also important here to note, and one of the main reasons that we decided to partner this program at the time we did, was, of course, investments into manufacturing capacity.
Adam Steensberg: ... Thank you for your, for your question. I think what we can reassure you is that we are, together with us, we are doing everything possible to accelerate, and we have identified some very good levers and have a lot of confidence that we can accelerate and push this program as fast as possible forward. We cannot share the, the details, also the exact details on, on submission timeline, due to the fact that this is a partnership, so we need to agree on, on when to, to discuss these things. But we, we are all on in both organizations to make sure that things are being accelerated towards submission and ultimately, announced. What is also important here to note, and one of the main reasons that we decided to partner this program at the time we did, was, of course, investments into manufacturing capacity.
Speaker #10: But I wonder if you could elaborate for the longer run, based on the knowledge today and the data sets that have been reported for the various amylin assets out there.
Speaker #10: How do you expect patralentide to be positioned within the amylin class? What would you expect in terms of differentiation versus the other amylines later down the line?
Speaker #10: And maybe one clarification about the research site in Boston. What will this help focus on and how would that complement the capabilities in Copenhagen?
Speaker #10: Thank you.
Speaker #6: Thank you, Suzanne. It is too early for us to share our thoughts about the ultimate differentiation between the different amylin analogs. We have been extremely pleased with the data that we have seen thus far when it comes to the balance between weight loss tolerability and safety findings also when we compare across the different modalities the different amylin analogs in the clinic today.
Adam Steensberg: And we have been extremely pleased to see the announcements that Roche has come out with, with regard to investments into high volume, high throughput manufacturing capacity, which, of course, is needed if you want to secure a successful launch, when these products hit the market. And I think that's, again, coming back to the uniqueness of the partnership we have here, and the uniqueness of Zealand today, is that we are, as I conveyed at our Capital Markets Day, and we continue to operate as a biotech company. But we will bring in the best from that world, but in the collaboration with us, we will also leverage the strength of a pharma company as we approach the market with the petrelintide.
Adam Steensberg: And we have been extremely pleased to see the announcements that Roche has come out with, with regard to investments into high volume, high throughput manufacturing capacity, which, of course, is needed if you want to secure a successful launch, when these products hit the market. And I think that's, again, coming back to the uniqueness of the partnership we have here, and the uniqueness of Zealand today, is that we are, as I conveyed at our Capital Markets Day, and we continue to operate as a biotech company. But we will bring in the best from that world, but in the collaboration with us, we will also leverage the strength of a pharma company as we approach the market with the petrelintide.
Speaker #6: So and we see a clear opportunity to continue to develop that differentiation that we have already observed until today. Another key aspect which I think is important to note as well is as we enter this market, this will be the number one two and three focus for Zealand to build patralentide into a leading molecule within the amylin class.
Speaker #6: Others will have to spend more time thinking about existing franchises and how to protect current molecules that are already on the market. And that's a strength and a force which I don't think people should underestimate.
Adam Steensberg: And I don't think you have seen many of these partnerships, but that is why we keep coming back to the strategic value and the, and of course, the profit share we have in this partnership is unique, and it's one which we are extremely pleased with, to see also how the, it progresses. We will hopefully soon be able to share more on the exact timelines as we move the program into phase 3, but it's just, perhaps one quarterly call too early.
Adam Steensberg: And I don't think you have seen many of these partnerships, but that is why we keep coming back to the strategic value and the, and of course, the profit share we have in this partnership is unique, and it's one which we are extremely pleased with, to see also how the, it progresses. We will hopefully soon be able to share more on the exact timelines as we move the program into phase 3, but it's just, perhaps one quarterly call too early.
Speaker #6: On the research side, in Boston, as Utpal shared a little bit on our Capital Markets Day, but it's really going to be a site that will complement what we do in Denmark.
Speaker #6: In Denmark, we are one of the strongest, if not the strongest research group within peptide chemistry and also having worked in metabolic diseases and health for more than 25 years, have very unique expertise in those areas.
Operator: Thank you. Thank you. We will take our next question. The question comes from the line of Suzanne van Voosteren from Kempen. Please ask your question.
Operator: Thank you. Thank you. We will take our next question. The question comes from the line of Suzanne van Voosteren from Kempen. Please ask your question.
Speaker #6: In Boston, we'll build complementary skills including focus on high-throughput research labs machines that are built labs that are built specifically to tap into the automatization that we are seeing in research these days.
Suzanne van Voorthuizen: Hi, team, this is Suzanne from Kempen. Thanks for taking my question. Looking beyond the phase 2b readout that we're all eagerly awaiting, I believe how petrelintide could provide an alternative to incretins and the product profile you're targeting is very clear. I wonder if you could elaborate for the longer run, based on the knowledge today and the data sets that have been reported for the various amylin assets out there. How do you expect petrelintide to be positioned within the amylin class? What would you expect in terms of differentiation versus the other amylins later down the line? Maybe one clarification about the research site in Boston. What will this help focus on, and how would that complement the capabilities in Copenhagen? Thank you.
Suzanne van Voorthuizen: Hi, team, this is Suzanne from Kempen. Thanks for taking my question. Looking beyond the phase 2b readout that we're all eagerly awaiting, I believe how petrelintide could provide an alternative to incretins and the product profile you're targeting is very clear. I wonder if you could elaborate for the longer run, based on the knowledge today and the data sets that have been reported for the various amylin assets out there. How do you expect petrelintide to be positioned within the amylin class? What would you expect in terms of differentiation versus the other amylins later down the line? Maybe one clarification about the research site in Boston. What will this help focus on, and how would that complement the capabilities in Copenhagen? Thank you.
Speaker #6: And on top of that, we are also going to broaden out to modalities beyond peptides. And part of that broadening out will be through partnerships.
Speaker #6: We just announced one in December with OGR which has to do with small molecules. What we expect to announce more partnerships, but we will also build some in-house capabilities so we can become best partners to these opportunities.
Speaker #6: So it's broadening beyond peptide modalities and it's also with a high focus on automatization and high-throughput really leading to our firm conviction that we can deliver industry-leading times from idea to the clinic as we build our infrastructure in the coming period.
Adam Steensberg: Thank you, Suzanne. It is too early for us to share our thoughts about the ultimate differentiation between the different amylin analogs. We have been extremely pleased with the data that we have seen thus far when it comes to the balance between weight loss, tolerability, and safety findings. Also when we compare across the different modalities, the different amylin analogs in the clinic today. So and we see a clear opportunity to continue to develop that differentiation that we have already observed until today. Another key aspect, which I think is important to note as well, is as we enter this market, this will be the number 1, 2, and 3 focus for Zealand, to build the petrelintide into a leading molecule within the amylin class.
Adam Steensberg: Thank you, Suzanne. It is too early for us to share our thoughts about the ultimate differentiation between the different amylin analogs. We have been extremely pleased with the data that we have seen thus far when it comes to the balance between weight loss, tolerability, and safety findings. Also when we compare across the different modalities, the different amylin analogs in the clinic today. So and we see a clear opportunity to continue to develop that differentiation that we have already observed until today. Another key aspect, which I think is important to note as well, is as we enter this market, this will be the number 1, 2, and 3 focus for Zealand, to build the petrelintide into a leading molecule within the amylin class.
Speaker #6: Thank you, Suzanne.
Speaker #7: Thank you. Once again, if you wish to ask a question, please press star one, one on your telephone. We will take our next question.
Speaker #7: And the question comes from Rajan Sharma from Goldman Sachs. Please go ahead. Your line is open.
Speaker #11: Hi. Thanks for taking the follow-up question. Could you just discuss the rationale for restarting development of a GIP analog? Firstly, just to clarify, is this the same asset which you previously deprioritized?
Speaker #11: And then just in terms of strategy here, do you expect to see monotherapy activity or is this really a combination asset for the future?
Speaker #11: And how should we think about that in the context of CT388, which is a GLP-1, GIP co-agonist? Thank you.
Adam Steensberg: Others will have to spend more time thinking about existing franchises and, how to protect, current, molecules that are already on the market. And that's a strength and a, and a force, which I don't think people should underestimate. On the research side, in Boston, as Utpal shared a little bit on, on our Capital Markets Day, but, it's really gonna be a site that will complement what we do in Denmark. In Denmark, we are one of the strongest, if not the strongest research group within peptide chemistry, and also having worked in metabolic diseases and health for more than 25 years, have very unique expertise in those areas.
Adam Steensberg: Others will have to spend more time thinking about existing franchises and, how to protect, current, molecules that are already on the market. And that's a strength and a, and a force, which I don't think people should underestimate. On the research side, in Boston, as Utpal shared a little bit on, on our Capital Markets Day, but, it's really gonna be a site that will complement what we do in Denmark. In Denmark, we are one of the strongest, if not the strongest research group within peptide chemistry, and also having worked in metabolic diseases and health for more than 25 years, have very unique expertise in those areas.
Speaker #6: Thank you, Rajan. I'll hand it over to David.
Speaker #12: Yeah. Thanks, Rajan. Yes. This is the asset that has been part of our pipeline all along. And as you have likely noted, I mean, the interest in leveraging GIP pharmacology while it is still in its infancy both with the development of Tirzeptide and other GLP-1 GIP molecules the recent announcement of Novo looking at combinations with an amylin analog.
Speaker #12: But our understanding as we've stated all along that combination therapies can ultimately be leveraged to target this complex metabolic set of disorders, obesity, and beyond.
Adam Steensberg: In Boston, we'll build complementary skills, including focus on high throughput research labs that are built specifically to tap into the automation that we are seeing in research these days. And on top of that, we are also going to broaden out to modalities beyond peptides. And you know, part of that broadening out will be through partnerships. We just announced one in December with OGI, which has to do with small molecules. But we expect to announce more partnerships, but we will also build some in-house capabilities, so we can become best partners to these opportunities.
Adam Steensberg: In Boston, we'll build complementary skills, including focus on high throughput research labs that are built specifically to tap into the automation that we are seeing in research these days. And on top of that, we are also going to broaden out to modalities beyond peptides. And you know, part of that broadening out will be through partnerships. We just announced one in December with OGI, which has to do with small molecules. But we expect to announce more partnerships, but we will also build some in-house capabilities, so we can become best partners to these opportunities.
Speaker #12: And while GIP monotherapy has been reported by others may not in and of itself have potent weight-reducing effects, the potential to further improve insulin action or insulin sensitivity, the ability to unlock even greater effect of other molecules including amylin analogs other Incretin hormones and other peptide signals is becoming clearer.
Speaker #12: And for us, this is yet another venture into the potential for combination approaches to targeting these complex metabolic diseases. And again, our commitment to improving metabolic health overall goes beyond, as Adam said, simply reducing body weight—simply targeting MASH—to improving things like insulin action, targeting specific aspects of fat cell or adipocyte behavior, and using this pharmacology to really target multiple tissues, multiple organs, and further enhance the effect of other peptide and non-peptide signals.
Adam Steensberg: It's broadening beyond peptide modalities, and it's also with a high focus on automation and high throughput, really leading to our firm conviction that we can deliver industry-leading times from idea to the clinic, as we build our infrastructure in the coming period. Thank you, Suzanne.
Adam Steensberg: It's broadening beyond peptide modalities, and it's also with a high focus on automation and high throughput, really leading to our firm conviction that we can deliver industry-leading times from idea to the clinic, as we build our infrastructure in the coming period. Thank you, Suzanne.
Operator: Thank you. Once again, if you wish to ask a question, please press star one, one on your telephone. We will take our next question, and the question comes from Rajan Sharma from Goldman Sachs. Please go ahead. Your line is open.
Operator: Thank you. Once again, if you wish to ask a question, please press star one, one on your telephone. We will take our next question, and the question comes from Rajan Sharma from Goldman Sachs. Please go ahead. Your line is open.
Rajan Sharma: Hi, thanks for taking the follow-up question. Could you just discuss the rationale for restarting development of a GIP analog? Firstly, just to clarify, is this the same asset which you previously deprioritized? And then just in terms of strategy here, do you expect to see monotherapy activity, or is this really a combination asset for the future? And how should we think about that in the context of CT-388, which is a GLP-1 GIP co-agonist? Thank you.
Rajan Sharma: Hi, thanks for taking the follow-up question. Could you just discuss the rationale for restarting development of a GIP analog? Firstly, just to clarify, is this the same asset which you previously deprioritized? And then just in terms of strategy here, do you expect to see monotherapy activity, or is this really a combination asset for the future? And how should we think about that in the context of CT-388, which is a GLP-1 GIP co-agonist? Thank you.
Speaker #12: So, starting with the first-in-human, to ensure understanding of the PK and safety and tolerability, and then we hope to rapidly advance into assessment of unique combinations with amylin assets and other signals.
Speaker #6: Thank you.
Speaker #7: Thank you. We will take our next question. The question comes from the line of Susan Cho from Wells Fargo. Please go ahead, your line is open.
Adam Steensberg: ... Thank you, Rajan. I will hand it over to David.
Adam Steensberg: ... Thank you, Rajan. I will hand it over to David.
David Kendall: Yeah, thanks, Rajan. Yes, this is the asset that has been part of our pipeline all along. And as you have likely noted, I mean, the interest in leveraging GIP pharmacology while it is still in its infancy, both with the development of tirzepatide and other GLP-1 GIP molecules. The recent announcement of Novo looking at combinations with an amylin analog. But our understanding, as we've stated all along, that combination therapies can ultimately be leveraged to target this complex metabolic set of disorders, obesity and beyond. And while GIP monotherapy, as has been reported by others, may not in and of itself have potent weight reducing effects.
David Kendall: Yeah, thanks, Rajan. Yes, this is the asset that has been part of our pipeline all along. And as you have likely noted, I mean, the interest in leveraging GIP pharmacology while it is still in its infancy, both with the development of tirzepatide and other GLP-1 GIP molecules. The recent announcement of Novo looking at combinations with an amylin analog. But our understanding, as we've stated all along, that combination therapies can ultimately be leveraged to target this complex metabolic set of disorders, obesity and beyond. And while GIP monotherapy, as has been reported by others, may not in and of itself have potent weight reducing effects.
Speaker #13: Hi. This is Susan on for Mohit. Just a quick question on Supreme One dose titration cohorts. Can you speak a little bit more on the rationale behind the timing and the step-up doses that were chosen for the trial?
Speaker #13: And as a follow-up, where do you expect to see the most improvement on the side effects?
Speaker #6: Thank you for your question. I would like the rationale for the—was it for the dose titration, or you could even say, is it even a titration? Because you could expect, of course, to see weight loss even at the lower doses, but it's the ability to get to the higher doses.
Speaker #6: Is a dosing escalation every four weeks a practical way to do it? Our Phase 1b data suggests that we could do more frequent dose escalation and not compromise the tolerability from a GI side effect profile—it was clean, as you remember.
David Kendall: The potential to further improve insulin action or insulin sensitivity, the ability to unlock even greater effect of other molecules, including amylin analogs, other incretin hormones, and other peptide signals, is becoming clearer. And for us, this is yet another venture into the potential for combination approaches to targeting these complex metabolic diseases. And again, our commitment to improving metabolic health overall goes beyond, as Adam said, simply reducing body weight, simply targeting MASH, to improving things like insulin action. Targeting specific aspects of fat cell or adipocyte behavior, and using this pharmacology to really target multiple tissues, multiple organs, and further enhance the effect of other peptide and non-peptide signals.
David Kendall: The potential to further improve insulin action or insulin sensitivity, the ability to unlock even greater effect of other molecules, including amylin analogs, other incretin hormones, and other peptide signals, is becoming clearer. And for us, this is yet another venture into the potential for combination approaches to targeting these complex metabolic diseases. And again, our commitment to improving metabolic health overall goes beyond, as Adam said, simply reducing body weight, simply targeting MASH, to improving things like insulin action. Targeting specific aspects of fat cell or adipocyte behavior, and using this pharmacology to really target multiple tissues, multiple organs, and further enhance the effect of other peptide and non-peptide signals.
Speaker #6: Except for one dosing arm where they started at a higher dose than what we do here. So it's also about the practical timing for dose escalation.
Speaker #6: I don't think we have the same issues as you have with the GLP-1s where you need to titrate carefully and remember also a lot of patients you will have to down-titrate when you have decided to titrate up and you have to back off for some weeks and then back up.
Speaker #6: That is what become that's why it becomes so complicated to get patients to the higher doses of the GLP-1, but we have not seen that with the amylins.
Speaker #6: In all our titration steps, we have seen patients being able to tolerate the next dose with any significant new adverse events. So for us, it's more a practical decision rather than something that has to decide with how you have to do it actually from a side effect profile.
David Kendall: So, starting with the first in human to ensure understanding of the PK on safety and tolerability, and then we hope to rapidly advance into assessment of unique combinations with amylin assets, and other signals.
David Kendall: So, starting with the first in human to ensure understanding of the PK on safety and tolerability, and then we hope to rapidly advance into assessment of unique combinations with amylin assets, and other signals.
Speaker #6: Thank you.
Speaker #7: Thank you. We will take our final question. The final question comes from the line of Jen Geer from Cantor Fitzgerald. Please go ahead. Your line is open.
Speaker #13: Thanks so much for taking this follow-up question. On 9830, the channel blocker, what indications would you consider pursuing and what would be the rationales for that?
Adam Steensberg: Thank you. Jen?
Adam Steensberg: Thank you. Jen?
Operator: Thank you. We will take our next question. The question comes from the line of Susan Shaw from Wells Fargo. Please go ahead. Your line is open.
Operator: Thank you. We will take our next question. The question comes from the line of Susan Shaw from Wells Fargo. Please go ahead. Your line is open.
Speaker #6: Yeah. So we have some very good ideas about where we want to take the molecule in next and also but you and what you should expect is that we will be pursuing several indications also in parallel.
Cerena Chen: Hi, this is Susan on for Mohit. Just a quick question on ZUPREME-1 dose titration cohorts. Can you speak a little bit more on the rationale behind the timing, and the step-up doses, that were chosen for the trial? And as a follow-up, you know, where do you expect to see the most improvement, on the side effects?
[Analyst] (Wells Fargo): Hi, this is Susan on for Mohit. Just a quick question on ZUPREME-1 dose titration cohorts. Can you speak a little bit more on the rationale behind the timing, and the step-up doses, that were chosen for the trial? And as a follow-up, you know, where do you expect to see the most improvement, on the side effects?
Speaker #6: Because if you look into the biology rationale, we are looking at what could become a pipeline in a product. It's too early for us to share which indications we are going for, but you should expect us to pursue several indications in parallel.
Speaker #6: It is a target that industry has been pursuing for a very long time without success because of the difficult nature of addressing this target.
Adam Steensberg: Thank you for your question. The rationale for the dose titration, or you could even say, is it even a titration because you could expect, of course, to see weight loss even at the lower doses. But it's the ability to get to the higher doses. A dosing escalation every 4 weeks is a practical way to do it. Our Phase 1b data suggests that we could do more frequent dose escalation and not compromise the tolerability from a GI side effect profile. It was clean, as you remember, except for 1 dosing arm where they started at a higher dose than what we do here. So it's also about the practical timing for dose escalation.
Adam Steensberg: Thank you for your question. The rationale for the dose titration, or you could even say, is it even a titration because you could expect, of course, to see weight loss even at the lower doses. But it's the ability to get to the higher doses. A dosing escalation every 4 weeks is a practical way to do it. Our Phase 1b data suggests that we could do more frequent dose escalation and not compromise the tolerability from a GI side effect profile. It was clean, as you remember, except for 1 dosing arm where they started at a higher dose than what we do here. So it's also about the practical timing for dose escalation.
Speaker #6: And that's also why as David shared before, we are extremely excited about the fact that we have not only seen PK but also clear effects of target engagement from a PD perspective.
Speaker #6: In the phase one study, we think we have something that could be a future jewel in our pipeline. But the specific indications we'll have to come back with later.
Speaker #13: Thank you.
Speaker #6: All right. Okay. And with that, I 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.
Adam Steensberg: I don't think we have the same issues as you have with the GLP-1, where you need to titrate carefully. And remember also a lot of patients, you will have to down titrate when you have decided to titrate up, then you have to back off for some weeks and then back off. That's why it becomes so complicated to get patients to the higher doses of the GLP-1. But we have not seen that with the amylin. In all our titration studies, we have seen patients being able to titrate to tolerate the next dose with any significant new adverse events. So for us, it's more a practical decision, rather than something that has to decide with how you have to do it actually from a side effect profile. Thank you.
Adam Steensberg: I don't think we have the same issues as you have with the GLP-1, where you need to titrate carefully. And remember also a lot of patients, you will have to down titrate when you have decided to titrate up, then you have to back off for some weeks and then back off. That's why it becomes so complicated to get patients to the higher doses of the GLP-1. But we have not seen that with the amylin. In all our titration studies, we have seen patients being able to titrate to tolerate the next dose with any significant new adverse events. So for us, it's more a practical decision, rather than something that has to decide with how you have to do it actually from a side effect profile. Thank you.
Speaker #6: Thank you.
Speaker #7: This concludes today's conference call. Thank you for participating. You may now
Operator: Thank you. We will take our final question. The final question comes from the line of Jen Jia from Cantor Fitzgerald. Please go ahead. Your line is open.
Operator: Thank you. We will take our final question. The final question comes from the line of Jen Jia from Cantor Fitzgerald. Please go ahead. Your line is open.
David Kendall: Thanks so much for taking this follow-up question. On ZP9830, the channel blocker, what indications would you consider pursuing, and what would be the rationales for that?
Jennifer Jia: Thanks so much for taking this follow-up question. On ZP9830, the channel blocker, what indications would you consider pursuing, and what would be the rationales for that?
Adam Steensberg: Yeah. So we have some very good ideas about where we want to take the molecule in next. And also what you should expect is that we will be pursuing several indications also in parallel. Because if you look into the biology rationale, we are looking at what could become a pipeline in a product. It's too early for us to share which indications we are going for, but you should expect us to pursue several indications in parallel. It is a target that industry has been pursuing for a very long time without success, because of the difficult nature of addressing this target.
Adam Steensberg: Yeah. So we have some very good ideas about where we want to take the molecule in next. And also what you should expect is that we will be pursuing several indications also in parallel. Because if you look into the biology rationale, we are looking at what could become a pipeline in a product. It's too early for us to share which indications we are going for, but you should expect us to pursue several indications in parallel. It is a target that industry has been pursuing for a very long time without success, because of the difficult nature of addressing this target.
Adam Steensberg: That's also why, as David shared before, we are extremely excited about the fact that we have not only seen PK, but also clear effects of target engagement from a PD perspective in the phase 1 study. So we think we have something that could be a future jewel in our pipeline. So, but the specific indications we'll have to come back with later.
Adam Steensberg: That's also why, as David shared before, we are extremely excited about the fact that we have not only seen PK, but also clear effects of target engagement from a PD perspective in the phase 1 study. So we think we have something that could be a future jewel in our pipeline. So, but the specific indications we'll have to come back with later.
David Kendall: Thank you.
David Kendall: Thank you.
Adam Steensberg: All right.
Adam Steensberg: All right.
Adam Lange: ... Okay, and with that, I 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.
Adam Lange: ... Okay, and with that, I 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.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.