Q2 2025 Zealand Pharma AS Earnings Call

As seen in pharma Dot com.

As described on slide two I caution listeners that during this call we will be making forward looking statements that are subject to risks and uncertainties.

Turning to slide three and today's agenda.

With me today are the following members of senior management team.

Thinks about president and Chief Executive Officer.

Henriette Atlantica, Chief Financial Officer.

Operator: Good day, and thank you for standing by. Welcome to the Zealand Pharma A/S interim report half-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.

And David Kendall Chief Medical Officer.

Speaker #2: Good day, and thank you for standing by. Welcome to the Zeeland Pharma interim report, half year 2025 conference call. At this time, all participants are in a listen-only mode.

All speakers would it be available for the subsequent Q&A session.

Moving to slide four I will now turn the call over to Adam thinks about president and CEO.

Thank you Adam.

Speaker #2: After the speakers' presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press *1, 1 on your telephone. You will then hear an automated message advising that your hand is raised.

And welcome everyone.

Today, we stand in a unique position to realize our vision to become a key player in the management of obesity.

We have a clearly differentiated mid to late states obesity pipeline with two leading programs intact and so we will decide.

Speaker #2: 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.

Backed by strong partners in the us and Boehringer Ingelheim.

Both programs are rapidly approaching key clinical readouts with phase II data for <unk> and phase III data for server to type in our sites.

Speaker #2: Vice President, Investor Relations. Please go ahead.

Adam Lange: Thank you, Rhoda Raiden, and thank you to everyone for joining us today to discuss Zealand Pharma A/S's results for the first six months of 2025. You can find the related company announcement on our website at zealandpharma.com. As described on slide two, I caution listeners that during this call, we will be making forward-looking statements that are subject to risks and uncertainties. Turning to slide three and today's agenda. With me today are the following members of Zealand Pharma A/S'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 subsequent Q&A session. Moving to slide four, I will now turn the call over to Adam Steensberg, President and CEO.

Speaker #3: Thank you, Henriette, and thank you to everyone for joining us today to discuss Zeeland Pharma's results for the first six months of 2025. You can find the related company announcement on our website at zeelandpharma.com.

Over the past two years, we have strengthened our organization and our internal capabilities, including recent appointments to our leadership team.

Speaker #3: As described on slide two, I caution listeners that during this call, we will be making forward-looking statements that are subject to risks and uncertainties.

With Pershing as Chief Scientific Officer will drive the next wave of innovation and Steven Johnson as Chief Development Officer will lead our development and regulatory strategies.

Speaker #3: Turning to slide three and today's agenda. With me today are the following members of Zeeland Pharma's management team: Adam Steensberg, President and Chief Executive Officer; Henriette Wennicke, Chief Financial Officer; and David Kendall, Chief Medical Officer.

Finally, our robust financial position ensures that the strongest possible foundation as we approach major upcoming catalysts for a leading obesity programs.

With this momentum <unk> pharma is entering a pivotal new chapter and I'm truly excited what lies ahead.

Speaker #3: All speakers will be available for the subsequent Q&A session. Moving to slide four, I will now turn the call over to Adam Steensberg, President and CEO.

Turning to slide five.

The Rush Alliance corporate franchise has begun exceptionally well with Russ we are rapidly advancing the petraeus at monotherapy program.

Adam Steensberg: Thank you, Adam, and welcome everyone. Today, we stand in a unique position to realize our vision to become a key player in the management of obesity. We have a clearly differentiated mid-to-late stage obesity pipeline with two leading programs, petrelintide and survodutide, backed by strong partners in Roche and Boehringer Ingelheim. Both programs are rapidly approaching key clinical readouts with Phase II data for petrelintide and Phase III data for survodutide in our sight. Over the past two years, we have strengthened our organization and our internal capabilities, including recent appointments to our leadership team. Utpal Singh, as Chief Scientific Officer, will drive the next wave of innovation, and Eric Cox, as Chief Development Officer, will lead our development and regulatory strategies. Finally, our robust financial position ensures the strongest possible foundation as we approach major upcoming catalysts for our leading obesity programs.

Speaker #4: Thank you, Adam. And welcome, everyone. Today, we stand in a unique position to realize our vision to become a key player in the management of obesity.

Since the 28 week data from the Supreme One phase II trial in hand, which is expected by the end of this year. The <unk> teams can move forward with the end of phase II meeting with the U S. FDA.

Speaker #4: We have a clearly differentiated mid-to-late stage obesity pipeline with two leading programs: Fitrinotype and Servutotype. Backed by strong partners in Ross and Berner Ingelheim.

We expect to report that 42 week data in the first half year of 2026 and initiate the phase III program with the <unk> monotherapy in the second half of 2026.

Speaker #4: Both programs are rapidly approaching key clinical readouts with phase two data for Fitrinotype and phase three data for Servutotype in our sites. Over the past two years, we have strengthened our organization and our internal capabilities including recent appointments to our leadership team, Ruth Palching, as Chief Scientific Officer, will drive the next wave of innovation, and Stephen Johnson, as Chief Development Officer, will lead our development and regulatory strategies.

Meanwhile.

We expect to initiate phase II for the first between type based combination product under the collaboration petroleum type combined with Russ leading interesting asset Cte 388, our potential best in class <unk> receptor dual agonist in the first half of 2026.

So it's full steam ahead with the us collaborations on the petroleum side clinical development program.

Speaker #4: Finally, our robust financial position ensures the strongest possible foundation as we approach major upcoming catalysts for our leading obesity programs. With this momentum, Zeeland Pharma is entering a pivotal new chapter, and I'm truly excited what lies ahead.

Under the collaboration Haas is responsible for all investments into commercial manufacturing and supply for <unk> and <unk> type based fixed dose combination.

Adam Steensberg: With this momentum, Zealand Pharma A/S is entering a pivotal new chapter, and I'm truly excited for what lies ahead. Turning to slide five, the Roche Alliance for petrelintide has begun exceptionally well. With Roche, we are rapidly advancing the petrelintide monotherapy program. Once the 28-week data from the ZP10068 Phase II trial are in hand, which is expected by the end of this year, the underlying teams can move forward with the end of Phase II meeting with the U.S. FDA. We expect to report the 42-week data in the first half of 2026 and initiate the Phase III program with petrelintide monotherapy in the second half of 2026. Meanwhile, we expect to initiate Phase II for the first petrelintide-based combination product under the collaboration, petrelintide combined with Roche leading inquiry in acid CT388, a potential best-in-class GLP-1 GLP-2 receptor dual agonist in the first half of 2026.

With regards to manufacturing readiness, we are truly impressed with the decisiveness and firmness with which us moves forward.

Speaker #4: Turning to slide five, the Ross Alliance for Fitrinotype has begun exceptionally well. With Ross, we are rapidly advancing the Fitrinotype monotherapy program. Once the 28-week data from the supreme one phase two trial are in hand, which is expected by the end of this year, the undying teams can move forward with the end of phase two meeting with the US FDA.

The early commitments and planning around manufacturing, where big reason why we chose them as our partner.

Theyre all right, they're already building out capacity at scale, including a state of the art high volume high throughput fill finish manufacturing facility in the U S.

These early and meaningful investments will significantly contribute to unlocking the full value potential of <unk> and our shared ambition to establish a leading Emily based franchise.

Speaker #4: We expect to report the 42-week data in the first half year of 2026. And initiate the phase three program with Fitrinotype monotherapy in the second half of 2026.

At the large pharma day on September 22nd we expect that they will provide further insights into their obesity strategy.

Speaker #4: Meanwhile, we expect to initiate Phase 2 for the first Fitrinotype-based combination product under the collaboration: Fitrinotype combined with Ross's leading ingestion asset, CT388, a potential best-in-class tier one DIP receptor dual agonist, in the first half of 2026.

And at our capital markets day in December where our PVC strategy will take center stage, we look forward to sharing updates on the programs and.

And in our efforts to become a key player in the management of obesity.

Let's move to slide six.

Adam Steensberg: It's full steam ahead with the Roche collaboration on the petrelintide clinical development program. Under the collaboration, Roche is responsible for all investments into commercial manufacturing and supply for petrelintide and the petrelintide-based fixed dose combination. With regards to manufacturing readiness, we are truly impressed with the decisiveness and firmness with which Roche moves forward. The early commitments and planning around manufacturing were a big reason why we chose them as our partner. They are already building out capacity at scale, including a state-of-the-art, high-volume, high-throughput fill-finish manufacturing facility in the U.S. These early and meaningful investments will significantly contribute to unlocking the full value potential of petrelintide and our shared ambition to establish the leading amyloid-based franchise. At the Roche Pharma Day on September 22nd, we expect that they will provide further insights into their obesity strategy.

It is without a doubt that new and better treatment options are needed to tackle one of the greatest health care challenges of our time.

Speaker #4: So, it's full steam ahead with the Ross collaboration on the Fitrinotype clinical development program. Under the collaboration, Ross is responsible for all investments into commercial manufacturing and supply for Fitrinotype and the Fitrinotype-based fixed-dose combination.

And with only a small fraction of eligible patients receiving pharmacotherapy today, we are clearly at the very early stage in the evolution of this market.

Speaker #4: With regards to manufacturing readiness, we are truly impressed with the decisiveness and firmness with which Ross moves forward. The early commitments and planning around manufacturing were a big reason why we chose them as our partner.

Which will require many therapeutic options with a range of different mechanisms to adequately address this chronic disease.

Real world treatment persistence with the tier one based therapies remains a challenge.

Highlighting a clear need for more tolerable symbol and patient friendly options.

Speaker #4: They are all right; they are already building out capacity at scale, including a state-of-the-art, high-volume, high-throughput fill-finish manufacturing facility in the U.S.

As an industry, we have to move away from focusing on speed and magnitude of weight loss. This is not consistent with what the vast majority of people with overweight and obesity desire.

Speaker #4: These early and meaningful investments will significantly contribute to unlocking the full value potential of Fitrinotype and our shared ambition to establish the leading amylin-based franchise.

We believe that our product with the best potential to become the preferred therapy for a broad population with overweight and obesity should deliver weight loss in the range of 10% to 20%.

Speaker #4: At the Ross Pharma Day on September 22nd, we expect that they will provide further insights into their obesity strategy. And at our Capital Markets Day in December, where our obesity strategy will take center stage, we look forward to sharing updates on the programs and on our efforts to become a key player in the management of obesity.

With the vast majority desire through a mechanism that offers a more positive patient experience.

Adam Steensberg: At our Capital Markets Day in December, where our obesity strategy will take center stage, we look forward to sharing updates on the programs and on our efforts to become a key player in the management of obesity. Let's move to slide six. It is without a doubt that new and better treatment options are needed to tackle one of the greatest healthcare challenges of our time. With only a small fraction of eligible patients receiving pharmacotherapy today, we are clearly at the very early stage in the evolution of this market, which will require many therapeutic options with a range of different mechanisms to adequately address this chronic disease. Real-world treatment persistence with GLP-1-based therapies remains a challenge, highlighting a clear need for more tolerable, simple, and patient-friendly options. As an industry, we have to move away from focusing on speed and magnitude of weight loss.

With improved tolerability, including fewer and Mazda gastrointestinal events, so that patients can better achieve and importantly maintain a healthy reduction in their body weight.

This is why we are so excited about the potential for <unk> to become a foundational therapy for weight management.

Speaker #4: Let's move to slide six. It is without a doubt that new and better treatment options are needed to tackle one of the greatest healthcare challenges of our time.

And with that let's move to slide seven as I turn over the call to our Chief Medical Officer, David Kendall to discuss our R&D pipeline David.

Speaker #4: And with only a small fraction of eligible patients receiving pharmacotherapy today, we are clearly at the very early stage in the evolution of this market.

Thank you Adam.

Today I would like to focus my remarks on the continued advancement of our leading programs in obesity and obesity.

Speaker #4: Which will require many therapeutic options with a range of different mechanisms to adequately address this chronic disease. Real-world treatment persistence with the tier one base therapies remains a challenge.

Got it.

Let's move to slide eight.

Together with our partner Roche, we are exceedingly well positioned to establish a leading amylin based franchise for weight management and rapidly expand to obesity related comorbidities.

Speaker #4: Highlighting a clear need for more tolerable, simple, and patient-friendly options. As an industry, we have to move away from focusing on speed and magnitude of weight loss, this is not consistent with what the vast majority of people with overweight and obesity desire.

Is that I'm, just mentioned and petroleum how it holds the potential of effective and well tolerated standalone therapy to address their needs.

Adam Steensberg: This is not consistent with what the vast majority of people with overweight and obesity desire. We believe that a product with the best potential to become the preferred therapy for a broad population with overweight and obesity should deliver weight loss in the range of 10% to 20%, which the vast majority desire through a mechanism that offers a more positive patient experience with improved tolerability, including fewer and milder gastrointestinal events, so that patients can better achieve and, importantly, maintain a healthy reduction in their body weight. This is why we are so excited about the potential for petrelintide to become a foundational therapy for weight management. With that, let's move to slide seven as I turn over the call to our Chief Medical Officer, David Kendall, to discuss our R&D pipeline. David.

Majority of people.

Okay.

Broad scope of the collaborations set forth in <unk> Zealand pharma Roche Alliance enables us to fully explore and unlock the potential of patrolling Todd.

Speaker #4: We believe that a product with the best potential to become the preferred therapy for a broad population with overweight and obesity should deliver weight loss in the range of 10 to 20%.

The first combination products under the alliance will target the segment of people, who need and desire greater weight loss and or improve glycemic control, while still leveraging the better tolerability of higher dose trolling tide.

Speaker #4: Which the vast majority desire through a mechanism that offers a more positive patient experience. With improved tolerability, including fewer and milder gastrointestinal events, so that patients can better achieve and importantly maintain a healthy reduction in their body weight.

Adding optimized dose doses of the <unk> based therapy.

Right.

Turning to slide nine.

Speaker #4: This is why we are so excited about the potential for Fitrinotype to become a foundational therapy for weight management. And with that, let's move to slide seven as I turn over the call to our Chief Medical Officer, David Kendall, to discuss our R&D pipeline.

In recent months research and development activity and amylin based treatments for Wade manager has increased significantly.

Two years ago, we faced some skepticism about our approach to Amazon as an effective and appealing standalone therapy and is an important alternative to GOP one based therapies today.

Speaker #4: David,

David Kendall: Thank you, Adam. Today, I would like to focus my remarks on the continued advancement of our leading programs in obesity and obesity-related comorbidities. Let's move to slide eight. Together with our partner, Roche, we are exceedingly well positioned to establish the leading amyloid-based franchise for weight management and rapidly expand into obesity-related comorbidities. As Adam just mentioned, petrelintide holds the potential as an effective and well-tolerated standalone therapy to address the needs of the majority of people with overweight and obesity. The broad scope of the collaboration set forth in the Zealand Pharma Roche Alliance enables us to fully explore and unlock the potential of petrelintide. The first combination product under the Alliance will target the segment of people who need and desire greater weight loss and/or improved glycemic control while still leveraging the better tolerability of higher dose petrelintide and adding optimized doses of the incretin-based therapy ZP9830.

Speaker #5: Thank you, Adam. Today, I would like to focus my remarks on the continued advancement of our leading programs in obesity and obesity-related comorbidities. Let's move to slide eight.

Today, However, Amazon is emerging as the next major class of potential therapies for weight management and.

In June we saw the first detailed phase III data for a long acting amylin analogue gorilla side.

Speaker #5: Together with our partner, Roche, we are exceedingly well positioned to establish the leading amylin-based franchise for weight management and rapidly expand into obesity-related comorbidities.

The long term data showed no unexpected safety signals in a gastrointestinal tolerability.

Demonstrating sooner.

Sure.

Speaker #5: As Adam just mentioned, Petrelotype holds the potential as an effective and well-tolerated standalone therapy to address the needs of the majority of people with overweight and obesity.

Gi adverse events observed with <unk> based therapies.

These data represent a major derisking event for the petroleum Dod program <unk> shares both a very similar receptor profile and the structure based on the human Amazon backbone like goodwill.

Speaker #5: The broad scope of the collaboration set forth in the Zeeland Pharma Roche Alliance enables us to fully explore and unlock the potential of Petrelotype.

Speaker #5: The first combination product under the alliance will target the segment of people who need and desire greater weight loss and/or improved glycemic control while still leveraging the better tolerability of higher dose Petrelotype, and adding optimized doses of the incretin-based therapy CT388.

That said there are several key molecule specific differences potentially mixed patrolling type superior which are worth reiterating.

Differences include petroleum chemical or physical stability.

Clos year round.

The ability to administer higher milligram doses a longer half life.

Greater bioavailability.

David Kendall: Turning to slide nine. In recent months, research and development activity in amyloid-based treatments for weight management has increased significantly. Two years ago, we faced some skepticism about our approach to amyloid as an effective and appealing standalone therapy and as an important alternative to GLP-1-based therapies. Today, however, amyloid is emerging as the next major class of potential therapies for weight management. In June, we saw the first detailed Phase III data for a long-acting amyloid analog, ZP10068. The long-term data showed no unexpected safety signals and a gastrointestinal tolerability profile that demonstrated considerably fewer and less severe GI adverse events than observed with GLP-1-based therapies. These data represent a major de-risking event for the petrelintide program, as petrelintide shares both a very similar receptor profile and a structure based on the human amyloid backbone, like ZP10068.

Speaker #5: Turning to slide nine, in recent months, research and development activity in amylin-based treatments for weight management has increased significantly. Two years ago, we faced some skepticism about our approach to amylin as an effective and appealing standalone therapy and as an important alternative to GLP-1-based therapies.

We have also seen additional early stage data from other amylin based programs, including enlarged derived from different backbones, such as Simon Cowell fulfillment or analogs with different receptor binding and activation profiles.

While these analogs.

Analogues contribute to the growing body of data available framework based therapies, we remain highly confident.

Speaker #5: Today, however, amylin is emerging as the next major class of potential therapies for weight management. In June, we saw the first detailed phase three data for a long-acting amylin analog, Quigrelotype.

Thanks.

Okay.

The very favorable Tolerability safety profile and the peptide construct itself underscoring petroleum <unk> value proposition and the potential to become the leading amylin based treatment.

Speaker #5: The long-term data showed no unexpected safety signals in a gastrointestinal tolerability profile that demonstrated considerably fewer and less severe GI adverse events than observed with GLP-1 based therapies.

Additional therapy.

Management.

Our confidence is grounded in the totality of data we've generated to date patrolling tide has demonstrated the potential to deliver the weight loss, but the vast majority of people with overweight and obesity desire even in studies that were conducted and are predominantly male population.

Speaker #5: These data represent a major de-risking event for the Petrelotype program, as Petrelotype shares both a very similar receptor profile and a structure based on the human amylin backbone, like Quigrelotype.

Relatively lower baseline BMI.

Factors that likely muted overall wheat production observed.

David Kendall: That said, there are several key molecule-specific differences that essentially make petrelintide superior, which are worth reiterating. These differences include petrelintide's chemical and physical stability, particularly around a neutral pH, the ability to administer higher milligram doses, a longer half-life, and greater bioavailability. We have also seen additional early-stage data from other amyloid-based programs, including analogs derived from different backbones, such as semin calcitonin, or analogs with different receptor binding and activation profiles. While these analogs contribute to the growing body of data available for amyloid-based therapies, we remain highly confident in petrelintide's consistent clinical response, the very favorable tolerability and safety profile, and the peptide construct itself, underscoring petrelintide's unique value proposition and potential to become the leading amyloid-based treatment and a foundational therapy for weight management. Our confidence is grounded in the totality of data we have generated to date.

Speaker #5: That said, there are several key molecule-specific differences that potentially make Petrelotype superior, which are worth reiterating. These differences include Petrelotype's chemical and physical stability, particularly around a neutral pH.

To support this we were pleased towards them on.

On slide 10, the additional data on individual responses.

And our 16 phase one b trial with patrol and time of this year's EBITDA.

Speaker #5: The ability to administer higher milligram doses, a longer half-life, and greater bioavailability. We have also seen additional early stage data from other amylin-based programs including analogs derived from different backbones such as salmon calcitonin.

Scientific sessions held in June.

Of note every individual spend treated with <unk> in this trial last week during the study.

Importantly, while only 21% of the trial participants were female greater treatment response was observed in females across all three patrolling five dose groups.

Speaker #5: Or analogs with different receptor binding and activation profiles. While these analogs contribute to the growing body of data available for amylin-based therapies, we remain highly confident in Petrelotype's consistent clinical response, stemming from the very favorable tolerability and safety profile of the peptide construct itself. This underscores Petrelotype's unique value proposition and potential to become the leading amylin-based treatment and a foundational therapy for weight management.

This leads me to slide 11.

Status update on the petroleum Todd Phase Twos premium program.

We have previously shared the trial designs for Supreme one and premium two Sorel mapco into priority.

Back in March we announced the completion of enrollment of more than 480 participants Supreme one and today, we are sharing the preliminary baseline characteristics.

Speaker #5: Our confidence is grounded in the totality of data we have generated to date. Petrelotype has demonstrated the potential to deliver the weight loss that the vast majority of people with overweight and obesity desire.

In this trial.

David Kendall: Petrelintide has demonstrated the potential to deliver the weight loss that the vast majority of people with overweight and obesity desire, even in studies that were conducted in a predominantly male population with a relatively lower baseline BMI, all factors that likely muted the overall weight reduction observed. To support this, we were pleased to present on slide 10 the additional data on individual responses of participants in our 16-week Phase 1B trial with petrelintide at this year's CDA 85th scientific session held in June. Of note, every individual participant treated with petrelintide in this trial lost weight during the study. Importantly, while only 21% of the trial participants were female, a greater treatment response was observed in females across all three petrelintide dose groups. This leads me to slide 11 for a brief status update on the petrelintide Phase II Supreme program.

<unk> has a population with the mean BMI of approximately 37 kilograms per meter squared at baseline and includes a balanced gender distribution with 53% of the participants being female notably different than the population studied in our phase one trials.

Speaker #5: Even in studies that were conducted in a predominantly male population, the relatively lower baseline BMI and both factors likely muted the overall weight reduction observed.

And we look forward to reporting top line results from <unk> in the first half of 2026.

Speaker #5: To support this, we were pleased to present on slide 10 the additional data on individual responses of participants in our 16-week phase one B trial with Petrelotype at this year's ADA 85th Scientific Sessions, held in June.

Turning now to slide 12 for a brief update on <unk>, our first in class GOP, one GOP two receptor dual agonist.

We were very encouraged by the top line results from part two of the phase one b trial with a higher dose.

Speaker #5: Of note, every individual participant treated with Petrelotype in this trial lost weight during the study. Importantly, while only 21% of the trial participants were female, a greater treatment response was observed in females across all three Petrelotype dose groups.

Alright announced in June.

These data showed a weight loss that is highly competitive compared to the currently available <unk> based therapies for weight management at similar time points. Despite.

Being studied in a predominantly male population again with a relatively lower baseline BMI.

Speaker #5: This leads me to slide 11, for a brief status update on the Petrelotype phase two supreme program. We have previously shared the trial designs for supreme one and supreme two, so I will not go into further detail here.

That said, we recognize the differentiation is absolutely essential and our strategy is to leverage <unk>.

David Kendall: We have previously shared the trial designs for Supreme One and Supreme Two, so I will not go into further detail here. Back in March, we announced the completion of enrollment of more than 480 participants in Supreme One, and today we are sharing the preliminary baseline characteristics of the participants in this trial. Supreme One has a population with a mean BMI of approximately 37 kilograms per meter squared at baseline and includes a balanced gender distribution with 53% of the participants being female, notably different than the population studied in our Phase I trials. We look forward to reporting top-line results from Supreme One in the first half of 2026. Turning now to slide 12 for a brief update on dapiglutide, our first-in-class GLP-1, GLP-2 receptor dual agonist.

<unk> looked at all right.

GOP to activity and move into a dedicated space to obesity related comorbidity trial in the second half of 2025.

Speaker #5: Back in March, we announced the completion of enrollment of more than 480 participants in Supreme One, and today we are sharing the preliminary baseline characteristics of the participants in this trial.

Now turning to slide 13, and servo times, a potential best in class Glucagon GOP one receptor dual agonist in late stage development for the treatment of obesity and Nash.

Speaker #5: Supreme One has a population with a mean BMI of approximately 37 kilograms per meter squared at baseline and includes a balanced gender distribution, with 53% of the participants being female.

We are rapidly approaching topline data synchronized.

Synchronized two phase III trials, which are evaluating the efficacy and safety.

Speaker #5: Notably different from the population studied in our Phase One trials. We look forward to reporting top-line results from SUPREME One in the first half of 2026.

Safety of Sirona tied in people with overweight or obesity, both with and without type two diabetes, respectively.

The design of the synchronized phase III program builds on key learnings from the phase II obesity trial, where trial participants achieved mean weight loss of up to 18, 7% or 46 weeks.

Speaker #5: Turning now to slide 12 for a brief update on dapaglutide, our first in class GLP-1, GLP-2 receptor dual agonist. We were very encouraged by the top line results from part two of the phase one B trial with higher doses of dapaglutide announced in June.

David Kendall: We were very encouraged by the top-line results from part two of the Phase 1B trial with higher doses of dapiglutide announced in June. These data showed a weight loss that is highly competitive compared to the currently available GLP-1-based therapies for weight management at similar time points, despite dapiglutide being studied in a predominantly male population, again with a relatively lower baseline BMI. That said, we recognize that differentiation is absolutely essential, and our strategy is to leverage the dual mechanism of dapiglutide, which includes GLP-2 activity, and move into a dedicated Phase II obesity-related comorbidity trial in the second half of 2025. Turning to slide 13 in survodutide, a potential best-in-class glucagon GLP-1 receptor dual agonist in late-stage development for the treatment of obesity and NASH.

Notably these phase III trials will assess even higher maximum doses of up to six milligrams.

Speaker #5: These data showed a weight loss that is highly competitive compared to the currently available GLP-1-based therapies for weight management at similar time points.

We remain extremely excited about the potential officer bonus novel dual agonist therapy per week.

And look forward to top line results from synchronize wanted to likely to be reported at the beginning of 2026.

Speaker #5: Despite dapaglutide being studied in a predominantly male population, again, with a relatively lower baseline BMI. That said, we recognize that differentiation is absolutely essential in our strategy to leverage the dual mechanism of dapaglutide, which includes GLP-2 activity, and move into a dedicated Phase 2 obesity-related comorbidity trial in the second half of 2025.

We're also very excited on slide 14 about the ongoing <unk> phase III program and people with metabolic dysfunction associated Seattle hepatitis or Nash.

Serious obesity related comorbidity with significant unmet medical need.

Shown on this slide is an indirect cross trial assessments of clinical trials with <unk> based therapies and match compared with the only approved therapy today.

Speaker #5: Now turning to slide 13 and Servutotype, a potential best in class glucagon GLP-1 receptor dual agonist in late stage development for the treatment of obesity and MASH.

Road hormone receptor beta agonist.

In the phase II trial with <unk> in people with Nash and liver fibrosis 38, 6% of adults with moderate to advanced scarring achieved the placebo adjusted biopsy confirmed improvement in fibrosis without worsening of Nash after 48 treatment.

David Kendall: We are rapidly approaching top-line data from SYNCHRONIZE-1 and SYNCHRONIZE-2 Phase III trials, which are evaluating the efficacy and safety of survodutide in people with overweight or obesity, both with and without type two diabetes, respectively. The design of the SYNCHRONIZE Phase III program builds on key learnings from the Phase II obesity trial, where trial participants achieved mean weight loss of up to 18.7% after 46 weeks. Notably, these Phase III trials will assess even higher maximum doses of up to 6 milligrams. We remain extremely excited about the potential of survodutide and novel dual agonist therapy for weight management and look forward to top-line results from SYNCHRONIZE-1 and -2, likely to be reported in the beginning of 2026.

Speaker #5: We are rapidly approaching top line data from the synchronized one and synchronized two phase three trials, which are evaluating the efficacy of safety and safety of Servutotype in people with overweight or obesity both with and without type two diabetes, respectively.

We believe this represents the most compelling and the strongest clinical data to date on the important endpoint of liver fibrosis improvements.

Speaker #5: The design of the synchronized Phase Three program builds on key learnings from the Phase Two obesity trial, where trial participants achieved a mean weight loss of up to 18.7% after 46 weeks.

The leverage program initiated in 2024 is the largest ever phase III Nash program with an anchor tenant base therapy and the only program to also include patients with compensated cirrhosis.

Speaker #5: Notably, these phase three trials will assess even higher maximum doses of up to six milligrams. We remain extremely excited about the potential of Servutotype and novel dual agonist therapy for weight management and look forward to top line results from synchronized one and two likely to be reported in the beginning of 2026.

With the best in class mass phase data and the robust phase.

Phase III program underway, we believe <unk> has the potential to become the therapy of choice in a large and growing market offering a much needed treatment option for people living.

David Kendall: We are also very excited on slide 14 about the ongoing survodutide Phase III program in people with metabolic dysfunction associated with steatohepatitis or NASH, a serious obesity-related comorbidity with significant unmet medical needs. Shown on this slide is an indirect cross-trial assessment of clinical trials with incretin-based therapies and NASH compared with the only approved therapy today, thyroid hormone receptor beta agonist. In the Phase II trial with survodutide in people with NASH and liver fibrosis, 38.6% of adults with moderate to advanced scarring achieved a placebo-adjusted biopsy-confirmed improvement in fibrosis without worsening of NASH after 48 weeks of treatment. We believe this represents the most compelling and strongest clinical data set to date on the important endpoint of liver fibrosis improvement.

Speaker #5: We are also very excited about the ongoing Servutotype phase three program in people with metabolic dysfunction associated with steatohepatitis, or MASH.

Turning now to slide 15, and apologies for the difficulties with the sound.

<unk> is licensed to Beringer Ingelheim as mentioned by Adam.

Speaker #5: A serious obesity-related comorbidity with significant unmet medical need. Shown on this slide is an indirect cross-trial assessment of clinical trials with incretin-based therapies and MASH.

As a family owned leading biopharmaceutical company with a strong legacy in cardiovascular renal and metabolic diseases and a global presence across 130 markets.

Speaker #5: Compared with the only approved therapy today, a thyroid hormone receptor beta agonist, the phase two trial with Servutotype in people with MASH and liver fibrosis showed that 38.6% of adults with moderate to advanced scarring achieved a placebo-adjusted biopsy-confirmed improvement in fibrosis, without worsening of MASH, after 48 weeks of treatment.

Beringer Ingelheim hold sole responsibility for the global development and commercialization of <unk> Zealand pharma has no financial obligations to either development or commercialization under this agreement, but it is entitled to percentage royalties on global sales ranging from high single digits to low double digits.

In addition, we are eligible for up to 350 million Euro and remaining outstanding milestone payments.

Speaker #5: We believe this represents the most compelling and strongest clinical data set to date on the important endpoint of liver fibrosis improvement. The LEVERAGE program, initiated in 2024, is the largest ever Phase 3 MASH program with an incretin-based therapy and the only program to also include patients with compensated cirrhosis.

Notably Beringer Ingelheim is an established leader in the CVR M in diabetes space, having developed and launched US leading <unk> inhibitor <unk> flows and the company has been instrumental in demonstrating <unk> benefits in reducing cardiovascular risk slowing the progression of chronic kidney disease and alleviate.

David Kendall: The LIVERAge program initiated in 2024 is the largest ever Phase III NASH program with an incretin-based therapy and the only program to also include patients with compensated cirrhosis. With the best-in-class NASH Phase II data and the robust, ambitious Phase III program underway, we believe survodutide has the potential to become the therapy of choice in a large and growing market, offering a much-needed treatment option for people living with.

Speaker #5: With the best in class MASH H phase two data and the robust ambitious phase three program underway, we believe Servutotype has the potential to become the therapy of choice in a large and growing market, offering a much-needed treatment option for people living with.

Adding the burden of heart failure.

Moving to slide 16 for a brief update on our rare disease programs.

For dessert glucagon in congenital hyperinsulinism or third party manufacturing facility has not yet received a classification upgrade.

Unknown Operator: Excuse me, Mr. Kendall, apologies for interrupting you. Unfortunately, your sound is breaking up and dipping in and out, so we are finding it difficult to hear you.

Speaker #2: Excuse me, Mr. Kendall, apologies for interrupting you. Unfortunately, your signal is breaking up and dipping in and out, so we're finding it difficult to hear you.

In the meantime, we have implemented a supply contingency plan that includes the qualification of an alternative supplier to ensure we can bring this product to patients in need as quickly as possible.

<unk> for the treatment of short bowel syndrome with intestinal failure. The phase III <unk> trial remains on track for initiation in the second half of 2025 to further support regulatory submission in the U S.

Adam Lange: Can you try to say something, David, again?

Speaker #6: Can you try to say something, David again?

David Kendall: Yes, can you hear me now, operator?

Speaker #5: Yes, can you hear me now, operator?

Unknown Operator: I can hear you now, yes.

Speaker #2: I can hear you now, yes.

David Kendall: Okay. Don't know the problem, but thank you, and I'll continue.

Speaker #5: Okay, don't know the problem, but thank you, and I'll continue.

In June we were pleased to announce the submission of a marketing authorization application to the European Medicines Association seeking approval of <unk> in the EU.

Unknown Operator: Thank you.

Speaker #2: Thank you.

David Kendall: Turning now to slide 15, and apologies for the difficulties with the sound. survodutide is licensed to Boehringer Ingelheim, as mentioned by Adam, and Boehringer Ingelheim is a family-owned leading biopharmaceutical company with a strong legacy in cardiovascular, renal, and metabolic diseases and a global presence across 130 markets. Boehringer Ingelheim holds sole responsibility for the global development and commercialization of survodutide. Zealand Pharma A/S has no financial obligations to either development or commercialization under this agreement but is entitled to percentage royalties on global sales ranging from high single digit to low double digit. In addition, we are eligible for up to 350 million euros in remaining outstanding milestone payments. Notably, Boehringer Ingelheim is an established leader in the CVRM and diabetes space, having developed and launched the leading SGLT2 inhibitor, Empagliflozin.

Speaker #6: Turning now to slide 15, and apologies for the difficulties with the sound. Servutotype is licensed to Beringer Ingelheim, as mentioned by Adam. BI is a family-owned leading biopharmaceutical company with a strong legacy in cardiovascular, renal, and metabolic diseases, and a global presence across 130 markets.

We remain incredibly excited and encouraged by the clinical profile of <unk> as a potential best in class long acting treatment for the management of short bowel syndrome with intestinal failure.

With that thank you very much for your attention and I would like to MAU turn the call over to our Chief Financial Officer Henriette <unk> to review our financial results for the first half of 2025 Henrietta.

Speaker #6: Beringer Ingelheim holds sole responsibility for the global development and commercialization of Servutotype, Zeeland Pharma has no financial obligations to either development or commercialization under this agreement, but is entitled to percentage royalties on global sales ranging from high single-digit to low double-digit.

Thanks, David and Hello, everyone, Let's turn to slide 17 on the income statement.

Revenue in the first six months of $2025 nine 1 billion DKK driven by the initial upfront payment under the collaboration and license agreement Middle ish.

Speaker #6: In addition, we are eligible for up to €350 million in remaining outstanding milestone payments. Notably, Boehringer Ingelheim is an established leader in the CVRM and diabetes space, having developed and launched the leading SGLT2 inhibitor, empagliflozin.

After nine 2 billion DKK in upfront payment received in June nine.

<unk> is recognized as revenue in connection with the closing of the agreement in May 2025.

David Kendall: The company has been instrumental in demonstrating Empagliflozin's benefits in reducing cardiovascular risk, slowing the progression of chronic kidney disease, and alleviating the burden of heart failure. Moving to slide 16 for a brief update on our rare disease programs. For dasiglucagon and congenital hyperinsulinism, our third-party manufacturing facility has not yet received a classification upgrade. In the meantime, we have implemented a supply contingency plan that includes the qualification of an alternative to supplier to ensure we can bring this product to patients in need as quickly as possible. For glepaglutide, for the treatment of short bowel syndrome with intestinal failure, the Phase III Ease Five trial remains on track for initiation in the second half of 2025 to further support regulatory submission in the U.S.

Speaker #6: The company has been instrumental in demonstrating empagliflozin's benefits in reducing cardiovascular risk, slowing the progression of chronic kidney disease, and alleviating the burden of heart failure.

The remaining 262 million PKK of the initial upfront payment is associated with Christian and completion of the phase two trials with the genzyme.

With 167 million DKK less deferred as of June 32025.

Speaker #6: Moving to slide 16, for a brief update on our rare disease programs. For daziglucagon in congenital hyperinsulinism, our third-party manufacturing facility has not yet received a classification upgrade.

Net operating expenses totaled 968 million TCE for the first half of 2025 of which 78% that's been on research and development.

Speaker #6: In the meantime, we have implemented a supply contingency plan that includes the qualification of an alternative to supplier to ensure we can bring this product to patients in need as quickly as possible.

<unk> expenses are mainly driven by the development of <unk>, including the last phase III trials and preparation for phase III.

And the expenses also reflect preparations for phase III, the tactical side increased investment, indicating one time, three channel plaza as well as development and regulatory activities.

Speaker #6: For glapaglutide, for the treatment of short bowel syndrome with intestinal failure, the phase three ES5 trial remains on track for initiation in the second half of 2025, to further support regulatory submission in the US.

Related to the rare disease programs.

David Kendall: In June, we were pleased to announce the submission of a marketing authorization application to the European Medicines Agency seeking approval of glepaglutide in the EU. We remain incredibly excited and encouraged by the clinical profile of glepaglutide as a potential best-in-class long-acting treatment for the management of short bowel syndrome with intestinal failure. With that, thank you very much for your attention. I would like to now turn the call over to our Chief Financial Officer, Henriette Wennicke, to review our financial results for the first half of 2025. Henriette?

Speaker #6: In June, we were pleased to announce the submission of a marketing authorization application to the European Medicines Agency seeking approval of glapaglutide in the EU.

Net financial items amounted to negative $157 million you can keep.

This is driven by exchange rate adjustments must primarily relate to USD deposits and currency revaluations on accounts receivables and cash equivalents. This was partly offset by interest income from the investment in marketable securities.

Speaker #6: We remain incredibly excited and encouraged by the clinical profile of glapaglutide as a potential best in class long-acting treatment for the management of short bowel syndrome with intestinal failure.

Let's move to slide 18, and the cash position.

Speaker #6: 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, to review our financial results for the first half of 2025.

As of June 32025, our cash position totaled $16 6 billion PK key a significant increase compared to the 9 billion DKK at the beginning of the year.

Speaker #6: Henriette?

Henriette Wennicke: Thanks, David, and hello, everyone. Let us turn to slide 17 on the income statement. Revenue in the first six months of 2025 was DKK 9.1 billion, driven by the initial upfront payment under the collaboration and license agreement with Roche. Of the DKK 9.2 billion in upfront payment received in June, DKK 9.0 billion was recognized as revenue in connection with the closing of the agreement in May 2025. The remaining DKK 262 million of the initial upfront payment is associated with the progression and completion of the Phase II trials with petrelintide, of which DKK 167 million was deferred as of June 30, 2025. Net operating expenses totaled DKK 968 million for the first half of 2025, of which 78% was spent on research and development. The R&D expenses are mainly driven by the development of petrelintide, including the last Phase II trial and preparation for Phase III.

Speaker #7: Thanks, David, and hello, everyone. Let's turn to slide 17 and the income statement. Revenue in the first six months of 2025 was DKK 9.1 billion, driven by the initial upfront payment under the collaboration and license agreement with Roche.

This is of course, driven by the initial upfront payment of $9 2 billion PKK from us partly offset by operating expenses for the period and the patience of Treasury shares to support Chinas long term incentive programs.

I would like to use the opportunity to remind everyone that on top of this very solid financial position, we are entitled to receive a total of $250 million U S dollars and embracing payments over the next two years under the <unk> collaboration as well as potential development milestones of up to $1 2 billion in U S dollars.

Speaker #7: Of the 9.2 billion DKK in upfront payment received in June, 9.0 billion DKK was recognized as revenue in connection with the closing of the agreement in May 2025.

Speaker #7: The remaining 262 million DKK of the initial upfront payment is associated with regression and completion of the phase two trials with Petrelotype. Of which 167 million DKK was deferred as of June 30, 2025.

The vast majority of these development milestones are tied to the initiation of phase III trials with <unk> monotherapy.

As I stated on our last quarterly earnings call I'm pleased with <unk> strong financial position.

Speaker #7: Net operating expenses total 968 million DKK for the first half of 2025, of which 78% was spent on research and development. The R&D expenses are mainly driven by the development of Petrelotype, including the last phase two trials and preparation for phase three.

We can fully on our own.

Application under the comprehensive cost collaborations opportune time and at the same time accelerate investments in the early stage pipeline to build the next wave of innovation.

Let's turn to slide 19 under financial guidance I'll keep this short as Don no changes to the outlook for the year, we reconfirm the finance with guidance on net operating expenses, which are expected to be between two and a $2 5 billion DKK, excluding transaction related costs associated with it.

Henriette Wennicke: R&D expenses also reflect preparation for Phase II with dapiglutide, increased investments in the KV 1.3 ion channel blocker, as well as development and regulatory activities related to the rare disease programs. Net financial items amounted to negative DKK 157 million. This is driven by exchange rate adjustments, which primarily relate to USD deposits and currency revaluations on account receivables and cash equivalents. This was partly offset by interest income from the investment in microhold securities. Let us move to slide 18 and the cash position. As of June 30, 2025, our cash position totals DKK 16.6 billion, a significant increase compared to the DKK 9 billion at the beginning of the year.

Speaker #7: R&D expenses also reflect preparation for Phase 2 with dapaglutide, increased investments in the KV1.3 ion channel blocker, as well as development and regulatory activities related to the rare disease programs.

Question agreement.

And with that I'll move to slide 20, and turn the call back to Adam for concluding remarks.

Speaker #7: Net financial items amounted to negative 157 million DKK. This is driven by exchange rate adjustments, which primarily relate to USD deposits and currency revaluations on account receivables and cash equivalents, which was partly offset by interest income from the investment in microhold securities.

Thank you Vivian.

Two years ago at our obesity R&D event in London.

Laid out at both vision to become a key player in the management of obesity through innovations that address one of the greatest health care challenges of our time.

Speaker #7: Let's move to slide 18 and the cash position. As of June 30, 2025, our cash position totaled 16.6 billion DKK, a significant increase compared to the 9 billion DKK at the beginning of the year.

Today, I can say with confidence that we are.

Exactly where we want to be towards realizing that vision.

We have this <unk> phase III, a BCC data and battery inside phase III data into our sites.

Henriette Wennicke: This is, of course, driven by the initial upfront payment of DKK 9.2 billion from Roche, partly offset by operating expenses for the period and the purchase of treasury shares to support Zealand Pharma A/S's long-term intensive programs. I would like to use the opportunity to remind everyone that on top of this very solid financial position, we are entitled to receive a total of $250 million in anniversary payments over the next two years under the Roche collaboration, as well as potential development milestones of up to $1.2 billion. The vast majority of these development milestones are tied to the initiation of Phase III trials with petrelintide monotherapy. As I stated on our last quarterly earnings call, I am pleased with our strong financial position.

Speaker #7: This is, of course, driven by the initial upfront payment of 9.2 billion DKK from Roche, partly offset by operating expenses for the period, and the purchase of treasury shares to support Zeeland Pharma's long-term intensive programs.

We have significantly strengthened our capabilities to execute and our financial position to both advance our clinical portfolio and invest in the next wave of innovation.

So please save the date for our capital markets day on December 11, when we will share further insights and updates and discuss why we are so excited about the prospects for Zealand pharma.

Speaker #7: I would like to use the opportunity to remind everyone that on top of this very solid financial position, we are entitled to receive a total of 250 million US dollars in anniversary payments over the next two years under the Roche collaboration, as well as potential development milestone of up to 1.2 billion US dollars.

I will now turn over the call to the operator, and we will be happy to address questions.

Thank you as a reminder to ask a question you will need to press star one one on your telephone.

Speaker #7: The vast majority of these development milestones are tied to the initiation of Phase 3 trials with Petrelotype in monotherapy. As I stated on our last quarterly earnings call, I'm pleased with our strong financial position.

Thank for your name to be announced to withdraw your question. Please press star one one at gain.

We will take our first question and the question comes from the line of <unk> Sharma from Goldman Sachs. Please go ahead. Your line is open.

Henriette Wennicke: We can fully honor our obligation under the comprehensive Roche collaboration for petrelintide and at the same time accelerate investment in the early stage pipeline to build the next wave of innovation. Let us turn to slide 19 on the financial guidance. I will keep this short as there are no changes to the outlook for the year. We confirmed the financial guidance on net operating expenses, which are expected to be between DKK 2 billion and DKK 2.5 billion, excluding transaction-related costs associated with the Roche agreement. With that, I will move to slide 20 and turn the call back to Adam for concluding remarks.

Speaker #7: We can't fully honor our obligation under the comprehensive Roche collaboration for Petrelotype, and at the same time, accelerate investments in the early-stage pipeline to build the next wave of innovation.

Hi, Thanks for taking my questions I've got a cut from petrol and Todd.

Firstly <unk>.

David Good to get your perspectives on the Laurel into.

Speaker #7: Let's turn to slide 19 and the financial guidance. I will keep this short as there are no changes to the outlook for the year.

<unk> data that we saw at Ada in June.

I'd be interested in your thoughts on how petrolane tied compassion and any learnings on what this means for the ongoing debate between ambulance productivity versus docker.

Speaker #7: We confirm the financial guidance on net operating expenses, which are expected to be between two and two and a half billion DKK, excluding transaction-related costs associated with the Roche agreement.

And then secondly, just on body composition with China as a secondary endpoint in <unk>, but at.

Speaker #7: And with that, I will move to slide 20 and turn the call back to Adam for concluding remarks.

Again, we saw that data from Nova <unk> redefined trials suggests that there was no benefit on body composition from the online component of <unk> relative to the <unk>.

Adam Steensberg: Thank you, Henriette. Two years ago, at our Obesity R&D event in London, we laid out a bold vision to become a key player in the management of obesity through innovations that address one of the greatest healthcare challenges of our time. Today, I can say with confidence that we are exactly where we want to be, realizing that vision. We have the survodutide Phase III obesity data and petrelintide Phase II data in our sites, and we have significantly strengthened our capabilities to execute and our financial position to both advance our clinical portfolio and invest in the next wave of innovation. Please save the date for our Capital Markets Day on December 11th, where we will share further insights and updates and discuss why we are so excited about the prospects for Zealand Pharma A/S.

Speaker #4: Thank you, Henriette. Two years ago, at our BCT R&D event in London, we laid out a bold vision to become a key player in the management of obesity through innovations that address one of the greatest healthcare challenges of our time.

I was just wondering if there's any reason why portfolio tied maybe different or should we expect any benefit here to be sort of an upside to your base case assumption. Thank you.

Thank you Rajiv maybe David you would take a first gulen hunting these.

Speaker #4: Today, I can say with confidence that we are exactly where we want to be, two words realizing that vision. We have the Servutotype phase three obesity data and Petrelotype phase two data in our sites.

These questions.

Yes, David.

Happy to.

On mute and hopefully clear on.

The microphone Rosanna. Thanks for your question I'm happy to provide perspective, I think the lower data, which are obviously youre early phase data in a relatively small population.

Speaker #4: And we have significantly strengthened our capabilities to execute and our financial position to both advance our clinical portfolio and invest in the next wave of innovation.

Speaker #4: So please save the date for our Capital Markets Day on December 11th, where we will share further insights and updates and discuss why we are so excited about the prospects for Zeeland Pharma.

As we alluded to in the prepared remarks.

Show Us that.

One of the other key players space, Eli Lilly has a great interest in amylin based therapies.

Adam Steensberg: I will now turn over the call to the operator, and will be happy to address questions.

Speaker #4: I will now turn over the call to the operator, and we'll be happy to address questions.

I think there was some excitement over the both the dosing regimen in the clinical response.

Unknown 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. To withdraw your question, please press star one, one again. We will take our first question, and the question comes from the line of Rajan Sharma from Goldman Sachs. Please go ahead, your line is open.

Speaker #2: Thank you. As a reminder, to ask a question, you will need to press *1, 1 on your telephone, and wait for your name to be announced.

I would say from our perspective.

Two very important key points, one you alluded to.

<unk> data that colleagues from Novo Nordisk reported in a separate session separate from the Lora poster presentation suggested that Laura like other.

Speaker #2: To withdraw your question, please press star one, one again. We will take our first question and the question comes from the line of Rajan Sharma from Goldman Sachs.

Our balanced Emlen agonist does result in an acute lowering of serum calcium in animal models, which suggests that Laura. Despite what is reported in what has been in some hands enamel and specific receptor profile.

Speaker #2: Please go ahead, your line is open.

External Analyst: Hi, thanks for taking my questions. I have a couple on petrelintide. Firstly, Adam, David, it would be good to get your perspectives on the amyloid-based therapies data that we saw at ADA in June. I am just interested in your thoughts on how petrelintide compares and any learnings on what this means for the ongoing debate between amyloid selectivity versus DACRA. Secondly, just on body composition, which I know is a secondary endpoint in Supreme One, but at ADA again, we saw that data from Novo's redefined trial suggests that there was no benefit on body composition from the amyloid component of Cagri-semma relative to the GLP-1. I am just wondering if there is any reason why petrelintide may be different or should we expect any benefit here to be an upside to your base case assumption. Thank you.

Speaker #8: Hi, thanks for taking my question. I've got a couple on Petrelotype. So, firstly, Adam, David, it would be good to get your perspectives. On the laurelintide data that we saw at ADA in June, I'd just be interested in your thoughts on how Petrelotype compares and any learnings on what this means for the ongoing debate between amylin selectivity versus DACRA.

It is very likely a more balanced store pan receptor activator across the calcitonin amylin, one enamel and three receptors.

That said the.

Clinical response in our mind, particularly at the two how cold the middle to high doses.

Speaker #8: And then secondly, just on body composition, which I know is a secondary endpoint in supreme one, but at ADA again, we saw that data from Novo's redefined trial suggests that there was no benefit on body composition from that amylin component of Cagrisemma relative to the GLP-1.

It is quite consistent with other drugs in this class. Despite the exuberant response in their highest dose group and the dosing interval.

Given the small data set there are also a lot of unknowns about this asset in particular the.

Speaker #8: So just wondering if there's any reason why Petrelotype may be different or should we expect any benefit here to be sort of an upside to your base case assumption.

The reports.

Several neuropsychiatric adverse events, which is distinctly different.

Speaker #8: Thank you.

Adam Steensberg: Thank you, Rajan. Maybe, David, you would take a first go on answering these questions. Can you hear us, David?

Speaker #4: Thank you, Rajan. Maybe David, you would take a first go on answering? These questions? Can you hear us, David?

What has been reported that both with good grill and tied in with petroleum side.

As well as headache, which.

<unk> has been reported with other <unk> agonists and indeed with <unk>.

David Kendall: Happy to. I am on mute and hopefully clear on the microphone. Rajan, thanks for your question. I am happy to provide perspective. I think the Alora data, which are obviously early phase data in a relatively small population, as we alluded to in the prepared remarks, show us that one of the other key players in the space, Eli Lilly, has a great interest in amyloid-based therapies. I think there was some excitement over both the dosing regimen and the clinical response. I would say from our perspective, two very important key points.

Speaker #5: Happy to. On mute and hopefully clear on the microphone. Rajan, thanks for your question. I'm happy to provide perspective; I think the laurel data which are obviously early phase data and a relatively small population.

Framework tied back in the day.

Provocative tests.

Initiate or trigger headache were enhanced with another.

<unk> agonist amylin receptor agonist.

So I'd say certainly.

Speaker #5: As we alluded to in the prepared remarks, we would like to highlight that one of the other key players in this space, Eli Lilly, has a great interest in amylin-based therapies.

Certainly encouraged that there is attention to this space, we do not see these data is clearly differentiating from.

Other immune based therapies, including patrolling side and as I alluded to we are quite pleased with the consistent and now our comprehensive dataset. We have pulled together from all the phase one trials and obviously phase two will tell us much more about that treatment response.

Speaker #5: I think there was some excitement over the both the dosing regimen and the clinical response. I would say from our perspective, two very important key points.

David Kendall: One, you alluded to data that colleagues from Novo Nordisk reported in a separate session, separate from the Alora poster presentation, suggested that Alora, like other balanced amyloid agonists, does result in an acute lowering of serum calcium in animal models, which suggests that Alora, despite what is reported and what has been in some hands, an amyloid-specific receptor profile, is very likely a more balanced or pan-receptor activator across the calcitonin, amyloid-1, and amyloid-3 receptors. That said, the clinical response in our mind, particularly at the two, I will call them middle to high doses, is quite consistent with other drugs in this class, despite the exuberant response in their highest dose group and the dosing interval.

Speaker #5: One, you alluded to data that colleagues from Novo Nordisk reported in a separate session separate from the laurel poster presentation. Suggested that laurel-like other balanced amylin agonists does result in an acute lowering of serum calcium in animal models, which suggests that laurel, despite what is reported and what has been in some hands an amylin-specific receptor profile, is very likely a more balanced or pan-receptor activator across the calcitonin amylin one and amylin three receptors.

To your question about body composition, Adam I'm happy to turn it back to you or make comments myself. Please go ahead David.

I think the novo data in a relatively small subset using a less precise.

Broader and more applicable approach, which is dexter.

Did not provide clear evidence of changes or preservation of muscle mass. However.

As you well know rhythm.

But there is now broad evidence from mountain clinical models and I emphasize non clinical models of amylin agonists are.

Speaker #5: That said, the clinical response in our mind, particularly at the two I'll call them middle to high doses, is quite consistent with other drugs in this class, despite the exuberant response in their highest dose group and the dosing interval.

Associated with significant preservation of lean mass, particularly in these high fat fed animals, who are gaining weight now that is very different than the older. Adults are those in clinical trials, who are usually at a high wage but stable.

Who would then.

Enrolling clinical trials.

David Kendall: I think given the small data set, there are also a lot of unknowns about this asset, in particular the reports of several neuropsychiatric adverse events, which is distinctly different than what has been reported both with Cagrilatide and with petrelintide, as well as headache, which has been reported with other amyloid agonists and indeed with Pramelantide back in the day. Provocative tests to initiate or trigger headache were enhanced with another amyloid agonist, amyloid receptor agonist. I would say, you know, certainly encouraged that there is attention to this space. We do not see these data as clearly differentiating from other amyloid-based therapies, including petrelintide. As I alluded to, we are quite pleased with the consistent and now comprehensive data set we have pulled together from all the Phase I trials, and obviously Phase II will tell us much more about that treatment response.

Speaker #5: I think given the small data set, there are also a lot of unknowns about this asset, particularly the reports of several neuropsychiatric adverse events, which are distinctly different from what has been reported both with Quigrelotype and with Petrelotype.

But we still remain quite confident that amylin based therapies, including patrolling Todd, particularly using the EMR based measurements, we are using in the subset of patients and Supreme One alright, Kevin will be the both the approach and the studies that will demonstrate.

Speaker #5: As well as headache, which has been reported with other amylin agonists and indeed with pramlintide back in the day. Provocative tests that initiate or trigger headache were enhanced with another amylin agonist, amylin receptor agonist.

Clearly as possible what happens to lean mass.

Importantly, while lean mass preservation to us is important because there is really a value add on top of what Adam and I alluded to and Thats a significant weight loss.

Particularly on the range of 10% to 20%.

The vast majority of patients desire and the Tolerability profile.

Speaker #5: So, I'd say certainly encourage that there is attention to this space. We do not see these data as clearly differentiating from other amylin-based therapies, including Petrelotide.

Effects on other Biomarkers of Exxon lean mass we think are.

Significant.

Value adds but not key to the success of these molecules.

Speaker #5: And as I alluded to, we are quite pleased with the consistent and now comprehensive data set we have pulled together from all the phase one trials.

Thank you.

Yeah.

Thank you.

Thank you.

We will take our next question.

Speaker #5: And obviously, phase two will tell us much more about that treatment response. To your question about body composition, Adam, I'm happy to turn it back to you or make comments myself.

Your next question comes from the line of Christy well Stewart from BNP Paribas. Please go ahead. Your line is open.

David Kendall: To your question about body composition, Adam, I am happy to turn it back to you or make comments myself.

Adam Steensberg: Please comment, David.

Hi, This is Steve I'll forget BMT Python.

Speaker #4: Please comment, David.

David Kendall: I think the Novo data in a relatively small subset, using a less precise but a broader and more applicable approach, which is DEXA, did not provide clear evidence of changes or preservation of muscle mass. However, as you well know, Rajan, there is now broad evidence from non-clinical models, and I emphasize non-clinical models, that amyloid agonists are associated with significant preservation of lean mass, particularly in these high-fat fed animals who are gaining weight. That is very different than older adults or those in clinical trials who are usually at a high weight but stable, who then enroll in clinical trials.

Speaker #5: Yeah. I think that Novo data in a relatively small subset using a less precise but broader and more applicable approach, which is DEXA, did not provide clear evidence of changes or preservation of muscle mass.

So two questions from me firstly on the kind of safety and Tolerability profile.

Turning to <unk>.

<unk> spoken about the target.

Between 15, and 20% annually before but I was wondering if you can give some more color on what you believe would be clinically meaningful in tonnage side effect Python and I noticed your slide indicating that.

Speaker #5: However, as you well know, Rajan, that there is now broad evidence from non-clinical models and I emphasize non-clinical models that amylin agonists are associated with significant preservation of lean mass, particularly in these high-fat-fed animals who are gaining weight.

Patients are not willing to make that any Gi AE signed license that kind of what do you believe with that submission.

Submission improvement.

<unk> kind of meaningful uptake and intolerant patients.

And maybe one on <unk>.

Statically tight.

Speaker #5: Now that is very different than older adults or those in clinical trials who are usually at a high weight but stable. Who then enroll in clinical trials.

Any read across that you see from the upcoming <unk> data. Some nice I, maybe you could talk to the potential lead times to address diseases, such as outlined in last microbial inflammation plays a role.

David Kendall: But we still remain quite confident that amyloid-based therapies, including petrelintide, particularly using the MR-based measurements we are using in the subset of patients in Supreme One, can and will be both the approach and the studies that will demonstrate as clearly as possible what happens to lean mass. Importantly, while lean mass preservation to us is important, there is really a value add on top of what Adam Steensberg and I alluded to, and that is significant weight loss, particularly in the range of 10% to 20% that the vast majority of patients desire, and the tolerability profile effects on other biomarkers effects on lean mass we think are significant value adds but not key to the success of these molecules.

Speaker #5: But we still remain quite confident that amylin-based therapies, including Petrelotype, particularly using the MR-based measurements we are using in the subset of patients in supreme one, can and will be the both the approach and the studies that will demonstrate as clearly as possible what happens to lean mass.

What you'd like to see maybe in your data organized nice upcoming data to give you the confidence to go heavy on the program that Youll. Starting later this year.

That would be great. Thank you.

Thank you guys, maybe I'll start and then David.

Additional insight to that.

And the ratio between efficacy and safety and Tolerability I think it is as we also alluded to in the prepared in my prepared remarks, a super important question because if you look out today most patients actually have the tools available that can provide them with the weight loss do control. The problem is most pace.

Speaker #5: Importantly, while lean mass preservation to us is important, there's really a value add on top of what Adam and I alluded to, and that's significant weight loss particularly in the range of 10 to 20% that the vast majority of patients desire.

Don't ever get to the highest doses and we think a large part of those because of side effects.

Speaker #5: And the tolerability profile. Effects on other biomarkers, effects on lean mass, we think are significant value adds, but not key to the success of these molecules.

And the other thing that we do market research you will learn is that if you ask individual patients they would.

Most of these patients would come back and tell you that they are looking for 10% to 20% weight loss, but it is also clear here that the biggest tenants is to not actually achieve the weight of those today, but actually maintain that if you. If you don't stay on therapy than most patients will regain the weight.

Adam Steensberg: Thank you.

Speaker #4: Thank you.

External Analyst: Thank you.

Speaker #8: Thank you.

Unknown Operator: Thank you. We will take our next question. Your next question comes from the line of Kirsty Rostuet from BNP Paribas Inc. Please go ahead, your line is open.

Speaker #2: Thank you. We will take our next question. Your next question comes from the line of Kirsty Rostuart from BNP Paribas Xane. Please go ahead, your line is open.

So when we talk about a tolerable profile.

And how we are designing our program with the train side is it is actually with that with that in mind to make sure we target not only the maximum weight loss, but the ups and the optimal ratio between weight loss and side effects and then what we've seen from our program. Thus far as David also alluded to is a very robust.

External Analyst: Hi there. Yeah, this is Kirsty Rostuet from BNP Paribas. Two questions from me. Firstly, on the safety and tolerability profile of petrelintide, you have spoken about the target weight loss between 15% and 20% annually before, but I was wondering if you could give some more color on what you believe would be clinically meaningful in terms of side effect profile. I noticed your slide indicating that over half of patients are not willing to accept any GIAE. In light of that, what do you believe would represent a sufficient improvement to over GLP-1s to induce a meaningful uptake in intolerant patients? One also on dapiglutide and any read across that you see from the upcoming Evoke data from Novo.

Speaker #9: Hi there, yeah, this is Kirsty Rostuart from BNP Paribas. So two questions from me. Firstly, on the kind of safety and tolerability profile, you've also said Petrelotype, you've kind of spoken about the target weight loss between 15 and 20% annually before, but I was wondering if you can give some more color on what you believe will be clinically meaningful in terms of side effect profile.

Set of data, suggesting.

Suggesting that ultimately with the dosing that we are pursuing we would expect to get into a mean weight loss of between 15, and 20% and if you look into the <unk> in particular side effects, but also the other side effects, we have seen minimum two notes.

Speaker #9: And I noticed your slide indicating that kind of over half of patients are not willing to accept any GIAE. So in light of that, kind of what do you believe would represent a sufficient improvement to over GLP-1s to induce a kind of meaningful uptake in intolerant patients?

Gi side effects in these cohorts when dosed at the levels and with the titration receives we use.

Speaker #9: And maybe one also on dapaglutide and any read across that you see from the upcoming Evoke data from Novo. Maybe you could talk to the potential to dapaglutide to address diseases such as Alzheimer's where microglial inflammation plays a role and what you'd like to see maybe in your own exploratory data or Novo's upcoming data to give you the confidence to go here beyond the program that you're starting later this year.

And it is actually.

External Analyst: Maybe you could talk to the potential for dapiglutide to address diseases such as Alzheimer's, where microglial inflammation plays a role, and what you would like to see maybe in your own exploratory data or Novo's upcoming data to give you the confidence to go here beyond the program that you are starting later this year. That would be great. Thank you.

Important to note also as we saw from the <unk> phase III data that is of course, not just about nausea vomiting that.

<unk> is also the severity of these are the mild moderate or severe and we at least solid interest debt and even the <unk> at the doses, where they delivered just about 12% weight loss it was almost entirely.

Speaker #9: That would be great. Thank you.

Adam Steensberg: Thank you, Chris. Maybe I will start and then see if David Kendall has additional insights to add. On the ratio between efficacy and safety and tolerability, I think it is, as we also alluded to in the prepared remarks, a super important question. Because if you look out today, most patients actually have the tools available that can provide them with the weight loss you are looking for. The problem is most patients do not ever get to the highest doses, and we think a large part of those are because of side effects. The other thing that we, if you do market research, you will learn is that if you ask individual patients, they would, overall, most of these patients would come back and tell you that they are looking for a 10% to 20% weight loss.

Speaker #4: Thank you, Kirsty. Maybe I'll start and then see if David has additional insight to add. On the ratio between efficacy and safety, tolerability, I think it is, as we also alluded to in the prepared remark, prepared remarks are super important question.

Which was in contrast to what you see with tier one based therapies. So its not only the event rate, but also the severity of the of these side effects that we think we can reduce significantly with our approach to <unk>.

Speaker #4: Because if you look out today, most patients actually have the tools available that can provide them with the weight loss they're looking for. The problem is most patients, don't ever get to the highest doses.

Mmm.

And then on <unk> and of course, I think they evoke study will be super important remember, it's rather low doses of it. The other one that has subsided. So that study, but we have also recognized that the.

Speaker #4: And we think that last part of those are because of side effects. And the other thing that we if you do market research, you will learn is that if you ask individual patients, they would overall, most of these patients would come back and tell you that they're looking for a 10 to 20% weight loss.

The profile of it the other one entity who could be interesting in <unk>.

He's like Alzheimer's it could also be interesting in a more ti driven inflammatory conditions such as IBD.

Adam Steensberg: But it is also clear that the biggest challenge is to not actually achieve the weight loss today, but actually maintain that. If you do not stay on therapy, then most patients will regain the weight. So when we talk about a tolerable profile, and how we are designing our program with petrelintide, it is actually with that in mind to make sure we target not only the maximum weight loss, but the optimal ratio between weight loss and side effects. What we have seen from our program thus far, as David Kendall also alluded to, is a very robust set of data suggesting that ultimately with the dosing that we are pursuing, we would expect to get into a mean weight loss of between 15% and 20%.

David do you want to add.

Speaker #4: But it's also clearly clear that the biggest challenge is not actually achieving the weight loss today, but actually maintaining that. If you don't stay on therapy, then most patients will regain the weight.

Further insights.

Just one thing to add and Christy thanks.

Adam's comment about what we clearly believe with <unk> agonists less common less severe but I would also add that different character of those Gi side effects and while thats difficult to tease out in clinical trials in the clinic and in particular experience back with Prime one side.

Speaker #4: So when we talk about a tolerable profile, we and how we are designing our program with Petrelotype, it is actually with that in mind to make sure we target not only the maximum weight loss, but the optimal ratio between weight loss and side effects and what we have seen from our program thus far as David also alluded to is a very robust set of data suggesting that ultimately with the dosing that we are pursuing, we would expect to get into a mean weight loss of between 15 and 20%.

Thus.

Sense of fullness satiety.

A feeling full more quickly in full faster is very different than the food diversion signaling the nausea.

Similarly, we will have a different character to Adam's point in our phase one program to date, only a single patient who discontinued treatment with patrolman's out out of all those exposed.

Adam Steensberg: If you look into the GI, in particular side effects, but also other side effects, we have seen minimum to no GI side effects in these cohorts when dosed at the levels and with the titration regimes we use. It is actually important to note also, as we saw from the Cagrilatide Phase III data, that it is of course not just about nausea or vomiting or other GI defects. It is also the severity of these. Are they mild, moderate, or severe? We at least saw with interest that even with Cagrilatide at the doses where they deliver just around 12% weight loss, it was almost an entirely mild event, which was in contrast to what you see with GLP-1-based therapies. So it is not only the event rate, but also the severity of these side effects that we think we can reduce significantly with our approach to amyloid.

Speaker #4: And if you look into the DI in particular side effects, but also other side effects, we have seen minimum to no DI side effects in these cohorts when dosed at the levels and with the titration regimes we use.

And in particular, when we started at lower doses and multiple ascending dose and titrated up.

Speaker #4: And it is actually important to note also as we saw from the Quigrelotype phase three data that it's of course not just about nausea or vomiting or other DI defects, it's also the severity of these.

Scheme, even though it was every other week.

Tolerability profile demonstrated say substantially fewer events.

Speaker #4: Are they mild, moderate, or severe? And we at least saw with interest that in even the Quigrelotype at the doses where they delivered just around 12% weight loss, it was almost entirely mild event, which was in contrast to what you see with GLP-1 based therapies.

Less severe than what we believe will be different characters or characteristics of that adverse event profile. The other comment I would make is.

What I emphasize which is a distinct difference between tolerability, particularly in a clinical trial, which is designed to keep people on therapy, yes, if the only therapy available to me as an increment based therapies I may tolerate it but women options become available is it the most acceptable therapy. So.

Speaker #4: So it's not only the event rate, but also the severity of these side effects that we think we can reduce significantly with our approach to amylin.

Adam Steensberg: Then on dapiglutide, of course I think the Evoke study will be super important. Remember, it is rather low doses of a GLP-1 that is applied into that study, but we have also recognized that the profile of a GLP-1 and a GLP-2 could be interesting in a disease like Alzheimer's. It could also be interesting in a more GI-driven inflammatory condition such as IBD. David Kendall, do you want to add further insights?

Speaker #4: And then on dapaglutide, and of course, I think the Evoke study will be super important. Remember, it's rather low doses of a GLP-1 that are applied. So that study, but we have also recognized that the profile of a GLP-1 and a GLP-2 could be interesting in a disease like Alzheimer.

We will.

Obviously, we strive to look more carefully at not just tolerability the reported effects, but how acceptable as this to those who take an Amazon based therapy versus any experience with an increase in base therapy.

Speaker #4: It could also be interesting in a more GI-driven inflammatory condition such as IBD. David, do you want to add further insights?

Yeah.

Thank you.

Thank you we.

We will take our next question then.

David Kendall: Yeah, just one thing to add. Kirsty, thanks to Adam Steensberg's comment about, you know, we clearly believe with amyloid agonists, less common, less severe, but I would also add that different character of those GI side effects. While that is difficult to tease out in clinical trials in the clinic, and in particular experience back with petrelintide, this sense of fullness, satiety, that sense of feeling full more quickly, feeling full faster, is very different than the food aversion signal and the nausea. We think similarly we will have a different character.

Speaker #5: Yeah, just one thing to add, and Kirsty, thanks. To Adam's comment about, you know, we clearly believe with amylin agonists, less common, less severe, but I would also add that there is a different character of those GI side effects. While that's difficult to tease out in clinical trials, in the clinic, and in particular experience back with pramlintide, the sense of fullness and satiety—that sense of feeling full more quickly, feeling full faster—is very different than the food aversion signal and the nausea. We think similarly it will have a different character.

Next question comes from the line of Michael <unk> from Nordea. Please go ahead. Your line is open.

Thank you very much.

Microphone one.

Couple of questions. So.

First maybe can you can you discuss sort of around the commitment <unk> et cetera.

With Roche.

Obviously, we've seen a lot of movement in the UBC model sort of a movement to PC market sizing forecast over time, so it's been sort of any.

Discussions in the in the collaboration.

Does that also change sort of what the bar is in terms of what and amylin can do in terms of monotherapy weight loss. When we look into the phase II readout in the first half of <unk>.

David Kendall: To Adam Steensberg's point, in our Phase I program to date, only a single patient who discontinued treatment with petrelintide out of all those exposed, and in particular when we started at lower doses in the multiple ascending dose and titrated up in a scheme, even though it was every other week, that tolerability profile demonstrated, I will say, substantially fewer events and less severe. What we believe will be different characters or characteristics of that adverse event profile. The other comment I would make is what I emphasize, which is a distinct difference between tolerability, particularly in a clinical trial which is designed to keep people on therapy. Yes, if the only therapy available to me is an incretin-based therapy, I may tolerate it, but when options become available, is it the most acceptable therapy?

Speaker #5: To Adam's point, in our phase one program to date only a single patient who discontinued treatment with Petrelotype out of all those exposed and in particular when we started at lower doses in the multiple ascending dose and titrated up in a scheme, even though it was every other week, that tolerability profile demonstrated I'll say substantially fewer events and less severe and what we believe will be different characters or characteristics of that adverse event profile.

2020 states for peloton.

And then secondly.

Maybe you can just try to discuss the sort of potential licensing or partnering strategy around the <unk>.

<unk> tied.

Well the phase II that youre doing with regards to Comorbidities.

Would that lead to sort of a conclusive.

So in order to start potential partnering discussions so how should we sort of evaluate the road.

Hurtful to pick a side following the phase III.

Speaker #5: The other comment I would make is what I emphasize, which is a distinct difference between tolerability particularly in a clinical trial, which is designed to keep people on therapy, yes, if the only therapy available to me is an incretin-based therapies, I may tolerate it, but when options become available, is it the most acceptable therapy?

Thank you, Michael and I will take.

Sharon This answer these questions. So if you think about the developments in the BC market right now we have been saying for quite some time that we think people ought to focus on who gets the highest weight those and who get it who can deliver the fastest because market research with patients would actually suggest you obviously at most patients had.

David Kendall: So we will obviously strive to look more carefully at not just tolerability, the reported effects, but how acceptable is this to those who take an amyloid-based therapy versus any experience with an incretin-based therapy?

Speaker #5: So we will obviously strive to look more carefully at not just tolerability, the reported effects, but how acceptable is this to those who take an amylin-based therapy versus any experience with an incretin-based therapy.

Looking for 10% to 20% weight loss and actually some patients struggle, if it's too fast they want a reasonable way to what they want to see see that something happens, but it can also be too fast.

I think that as the market condition with Loopnet that is what I would describe as good one launched fatigue and actually not a BC fatigue and for.

Unknown Operator: Thank you. We will take our next question. The next question comes from the line of Michael Novid from Nordia. Please go ahead, your line is open.

Speaker #9: Thank you.

Speaker #2: Thank you. We will take our next question. The next question comes from the line of Michael Novot from Nordea. Please go ahead, your line is open.

You can say companies, who have set out on a mission to address what we consider the biggest health care challenges of our time.

For us and I would include us in that kind of statement that as an opportunity. What we are looking into at the moment that is.

External Analyst: Thank you very much. Michael from Nordia, a couple of questions. First, maybe can you discuss around the commitment priorities, et cetera, with Roche? Obviously, we have seen a lot of movement in the obesity market and also a lot of movement to obesity market sizing forecasts over time. Has there been any big discussions in the collaboration, and has that also changed what the bar is in terms of what an amyloid can do in terms of monotherapy weight loss when we look into the Phase II readout in the first half of 2026 for petrelintide? Secondly, maybe you can just try to discuss the potential licensing or partnering strategy around dapiglutide. Will the Phase II that you are doing with regards to comorbidities lead to conclusive results in order to start potential partnering discussions, or how should we evaluate the road ahead for dapiglutide following the Phase II?

Speaker #6: Thank you very much. Michael from Nordea. A couple of questions. So first, maybe can you discuss sort of around the commitment priorities, et cetera, with Roche?

Basically identifying the shortcomings of the current medicines out there and suggesting where we can actually play we can be out there with a medicine that delivers weight loss that are quite similar to what we what the products are doing today, but hopefully with a more tolerable profile and allow more patients to stay on therapy are.

Speaker #6: Obviously, we've seen a lot of movement in the obesity market and also a lot of movement to obesity market sizing forecasts over time. So it's been sort of any big discussions in the collaboration.

Speaker #6: And has that also changed sort of what the bar is in terms of what an amylin can do in terms of monotherapy weight loss when we look into the phase two readout in the first half of 2026 for Petrelotype?

A key part of why we chose to partner with US was that they already a few years ago to good big step into this space and they have had a very strong commitment to wanting to get into this space and need. So this we wanted somebody who has the same ambition is us somebody who don't just want to get in because it.

Speaker #6: And then secondly, maybe you can just try to discuss the sort of potential licensing or partnering strategy around dapaglutide will the phase two that you're doing with regards to comorbidities, will that lead to sort of a conclusive results in order to start potential partnering discussions or how should we sort of evaluate the road ahead for dapaglutide following the phase two be?

Was the talk of the town, but a company who really means it and this is what we tried to allude to in the prepared remarks that we are extremely impressed to see the suddenness with which the move forward. We will of course extremely pleased to see also the investments into manufacturing capacity I think sometimes.

<unk> overlook that is not just about <unk>.

A clinical data set and then a decision to move forward because once you decide to move forward. If you wanted to be launched ready you need to make very substantial investments into manufacturing otherwise you will face the issues that the two frontline is faced with supply constraints and what follows them. So.

Adam Steensberg: Thank you, Michael. I will take a shot on these questions. If you think about the developments in the obesity market right now, we have been saying for quite some time that we think people are too focused on who gets the highest weight loss and who can deliver it the fastest because market research with patients would actually suggest the opposite. Most patients are looking for a 10% to 20% weight loss, and actually some patients struggle if it is too fast. They want a visible weight loss. They want to see that something happens, but it can also be too fast. I think that is the market condition we are looking at. That is what I would describe as GLP-1 launch fatigue and actually not obesity fatigue.

Speaker #4: Thank you, Michael, and I'll take a shot at these answers. So, these questions. If you think about the developments in the obesity market right now, we have been saying for quite some time that we think people are too focused on who gets the highest weight loss and who can deliver at the fastest, because market research with patients would actually suggest the opposite.

Our sense in our dialogue with US is that they are as committed if not even more as they have been for a long time to come into this market and become a leading company to address what we both companies see.

Speaker #4: Most patients are looking for 10 to 20% weight loss. And actually, some patients struggle if it's too fast, they want a visible weight loss, they want to see that something happens, but it can also be too fast.

The biggest health care challenges of our time and if anything I would say the bar for success is being lower in my mind. These days because more and more people realize that is a few patients that are calling for that 25% plus weight loss.

Speaker #4: So I think that is the market condition we are looking at. That is what I would describe as GLP-1 launch fatigue and actually not obesity fatigue.

Adam Steensberg: For companies who have set out on a mission to address what we consider the biggest healthcare challenge of our time, for us, and I would include us in that kind of statement, that is an opportunity what we are looking into at the moment. That is basically identifying the shortcomings of the current medicines out there and suggesting where we can actually play. We can be out there with a medicine that delivers the weight loss that are quite similar to what the products are doing today, but hopefully with a more tolerable profile and thus allow more patients to stay on therapy. A key part for why we chose to partner with us was that they already, a few years ago, took a big step into this space, and they have had a very strong commitment to wanting to get into this space and lead.

Speaker #4: And for you can say companies who have set out on a mission to address what we consider the biggest healthcare challenge of our time, for us, and I would include us in that kind of statement, that is an opportunity.

And realistically those patients who need the highest weight loss.

More likely to benefit for combination therapy, rather than single modality that is how you treat chronic diseases that is by combining different modalities. If you need more fit than what one modality can do you very solvency people maxing out on one with LSE, because often you will see.

Speaker #4: What we are looking into at the moment, that is basically identifying the shortcomings of the current medicines out there and suggesting where we can actually play we can be out there with a medicine that delivers the weight loss that are quite similar to what the products are doing today, but hopefully with a more tolerable profile and thus allow more patients to stay on therapy.

Side effects and safety concerns following pushing things too much it's much better to combine.

So I think we are just being confirmed in these months and years.

Speaker #4: A key part for why we chose to partner with Roche was that they already, a few years ago, took a big step into this space and they have had a very strong commitment to wanting to get into this space and lead so this we wanted somebody who has the same ambition as us, somebody who don't just want to get in because it was the talk of the town, but a company who really means it.

And the strategy and I think also.

It feels the same.

On the good side Phase III program I think it's a very fair observation that.

Adam Steensberg: We wanted somebody who has the same ambition as us, somebody who does not just want to get in because it was the talk of the town, but a company who really means it. This is what we try to allude to during the prepared remarks that we are extremely impressed to see the firmness with which they move forward. We were, of course, extremely pleased to see also the investments into manufacturing capacity. I think sometimes it is overlooked that it is not just about a clinical data set and then a decision to move forward because once you decide to move forward, if you want to be launch ready, you need to make very substantial investments into manufacturing. Otherwise, you will face the issues that the two front runners faced with supply constraints and what follows there.

Our focus right now is to get the phase III study started to clearly identify the different differentiation potential for <unk> in addressing inflammation to a large extent than the other ones and then our hope of course will be following those data we will go out and discuss with potential partners on that program.

Speaker #4: And this is what we try to allude to in the prepared remarks: we are extremely impressed to see the firmness with which we move forward.

Speaker #4: We were of course extremely pleased to see also the investments into manufacturing capacity. I think sometimes it's overlooked that it's not just about a clinical data set and then a decision to move forward because once you decide to move forward, if you want to be launch ready, you need to make very substantial investments into manufacturing.

<unk>.

But but we also recognize that we need those data in hand, before we will have sufficient clinical excitement to progressive partnership.

Ownership discussions on that.

Okay, great. Thank you. Thank you.

Thank you.

Speaker #4: Otherwise, you will face the issues that the two frontrunners faced with supply constraints and what follows there. So our sense in our dialogue with Roche is that they are as committed if not even more as they have been for a long time to come into this market and become a leading company to address what we both companies see as the biggest healthcare challenge of our time.

We will go to our next question.

Your next question comes from the line of Andy Hsieh from William Blair. Please go ahead. Your line is open.

Adam Steensberg: Our sense in our dialogue with Roche is that they are as committed, if not even more, as they have been for a long time to come into this market and become a leading company to address what both companies see as the biggest healthcare challenge of our time. If anything, I would say the bar for success is being lowered in my mind these days because more and more people realize that it is very few patients that are going for that 25% plus weight loss. Realistically, those patients who need the highest weight loss are more likely to benefit from combination therapies rather than single modalities. That is how you treat chronic diseases. That is by combining different modalities if you need more effect than what one modality can do.

Great. Thanks, Thanks for taking our question I appreciate the additional color about easy clean one baseline characteristics potentially hit.

Hinting at a better outcome than <unk> seen before.

Key question for two questions for us.

Speaker #4: And if anything, I would say the bar for success is being lowered in my mind these days because more and more people realize that it's very few patients that are going for that 25% plus weight loss.

One has to do with Roche this manufacturing infrastructure that you announced in the press release and the synergy that can be derived from that.

That project.

I'm curious, though.

Speaker #4: And realistically, those patients who need the highest weight loss are more likely to benefit for combination therapies rather than single modalities; that is how you treat chronic diseases, that is by combining different modalities if you need more effect than what one modality can do.

<unk> and <unk>.

Jason.

Lead.

He said that April our recombinant so I'm just curious if you could comment on that.

The second one has to do with the titration strategy when it comes to the Phase II combo study that is expected to start later this year with <unk> and Cte.

Adam Steensberg: You very seldom see people maxing out on one modality because often you will see side effects and safety concerns following pushing things too much. It is much better to combine. I think we are just being confirmed in these months and years on the strategy, and I think us feels the same. On the dapiglutide Phase II program, I think it is a very fair observation that our focus right now is to get the Phase II study started to clearly identify the differentiation potential for dapiglutide in addressing inflammation to a larger extent than the other GLP-1s. Our hope, of course, will be that following those data, we will go out and discuss with potential partners on that program. We also recognize that we need those data in hand before we will have sufficient clinical excitement to progress partnership discussions on dapiglutide.

Speaker #4: You very seldom see people maxing out on one modality because often you will see side effects and safety concerns following pushing things too much, it's much better to combine.

Yeah.

Are you thinking about.

Something that could be a little bit different from what we've seen and redefine one and two.

Speaker #4: So I think we are just being confirmed in these months and years on the strategy, and I think us feels the same. On the dapaglutide Phase II program, I think it's a very fair observation that our focus right now is to get the Phase II study started to clearly identify the differentiation potential for dapaglutide in addressing inflammation where large extent than the other GLP-1s. And then our hope, of course, will be that following those data, we will go out and discuss with potential partners on that program.

In sync titration or may be stagnated titration, basically titration, what type trading one followed by the other than the following week just curious about how.

How do you think about titration strategy that optimize tolerability profile. Thank you.

Thank you Andy I will answer your first question and then hand over to David.

When we announced that they had manufacturing capacity expansions that have been announced in North Carolina.

Speaker #4: But we also recognize that we need those data in hand before we will have sufficient clinical excitement to progress a partnership this discussions on that.

Is there is a high capacity high volume still finished capacity. So that is the drug product filling lines and it's actually the critical path of <unk>.

Getting products to patients that have these the filling.

External Analyst: Okay, great. Thank you.

Speaker #6: Okay, great. Thank you.

Adam Steensberg: Thank you.

Filling capacity up running for <unk>.

Speaker #4: Thank you.

Unknown Operator: Thank you. We will go. Our

Speaker #2: Thank you. We will go to our next question. Your next question comes from the line of Andy Sheeh from William Blair. Please go ahead, your line is open.

Rhoda Raiden: Next question comes from the line of Andy Shee from William Blair. Please go ahead, your line is open.

It is where we have seen supply constraints, historically, and it's totally where we need the biggest investments when it comes to API a synthesis of the program.

It's actually easier to handle and it can be handled with with sky.

Operator: Great, thanks for taking our questions. Appreciate the additional color about the survodutide baseline characteristics, potentially hinting at a better outcome than what we've seen before. Two questions for us. One has to do with Roche's manufacturing infrastructure that you announced in the press release and the synergy that can be derived from that project. I am curious if both the petrelintide and ZP9830 are produced with the same means, synthetic or recombinant. I am just curious if you can comment on that. The second one has to do with the titration strategy when it comes to the Phase II combo study that is expected to start later this year with petrelintide and ZP9830.

Speaker #10: Great. Thanks for taking our questions. Appreciate the additional color about the supreme one baseline characteristics, potentially hinting at a better outcome than what we've seen before.

Suppliers and infrastructure that are more or less.

We will need investments, there as well, but it's actually that.

To finish and drug product filling lines.

Speaker #10: Two questions for two questions for us. One has to do with Roche's manufacturing infrastructure that you announced in the press release, and the synergy that can be derived from that project.

Causing shortage is also where you can probably gain the biggest benefits by making sure you have high volume.

Lines.

Because it is the most customer part of your.

Speaker #10: I'm curious if both Petrelotype and 388 are produced with the same means. I.e., synthetic or recombinant, so I'm just curious if you can comment on that.

Of your food product.

Understood. This is Pat we have you can say all things in place to support the amount of drug substance needed for launch in those plans.

We actually already being built by US before we entered the partnerships.

David.

Yes.

Thank you Adam and Andy Thanks for the question I think you already alluded to what for US is an opportunity to do things.

Operator: Are you thinking about something that could be a little bit different from what we have seen in Redefine 1 and 2, with the in-sync titration or maybe staggered titration, basically titrating one followed by the other the following week? I am just curious about how you think about this titration strategy that could optimize tolerability profile. Thank you.

Significantly differently than it was executed in the redefined program where.

As you know both both assets.

Some dosing.

Doses were essentially tied together.

Meaning you.

Escalated one you escalator together.

Similarly.

The goal in that program for August studies were complex was to push to higher doses and also to push for greater weight loss.

Adam Lange: Thank you, Andy. I will answer your first question, then hand over to David. When we announced the manufacturing capacity expansions that have been announced in North Carolina by us, it is a high capacity, high volume fill-finish capacity. So that is drug product and filling lines. It is actually the critical part of getting products to patients to have the filling capacity up and running for pre-filled pens. It is where we have seen supply constraints historically, and it is probably where we need the biggest investments. When it comes to API or synthesis of the program, it is actually easier to handle, and it can be handled with suppliers and infrastructure that are more or less.

A tough to answer in a single study.

With the fixed dose combination with petroleum died.

Eight eight obviously.

Obviously phase II data will provide us the necessary information to understand.

Which doses can optimize the clinical response, but balancing without them and I have both referred to which is the tolerability and acceptability profile of each asset.

We are discussing multiple options, but instead of maximizing each I would say our goal in phase two will be to optimize each I mean, we would anticipate that.

That is higher dose.

Malone.

Based therapy patrolling Todd.

Apps, the maximally affected effective doses.

Adam Lange: We will need investments there as well, but it is actually the fill-finish and drug product filling lines that are causing shortages. It is also where you can probably gain the biggest benefits by making sure you have high volume lines because it is the most costly part of your full product. On the synthesis part, we have, you can say, all things in place to support the amount of drug substance needed for launch. Those plans were actually already being built by us before we entered the partnership. David?

If it in fact remains as well tolerated as we've seen in the early phase trials, while then adding what I'll call, an optimized but not necessarily maximal dose of the <unk> based therapy.

Two <unk>.

Provide additional weight loss glycemic control for those with diabetes potentially cardiovascular risk reduction.

So in discussions with our <unk> partners.

This will be I'll call. It a high petroleum tied to low 388 high mid or high high.

I think we collectively in the alliance with Roche agree that if you go to high doses of both you will achieve the greatest weight loss, but balancing that with Unacceptability Union Tolerability profile, where we think we can fully leverage.

Adam Steensberg: Yep. Thank you, Adam and Andy. Thanks for the question. I think you already alluded to what for us is an opportunity to do things significantly differently than was executed in the Redefine program where, as you know, both assets, the Kagri and Sema, doses were essentially tied together, meaning you escalated one, you escalated the other. Similarly, the goal in that program, while the studies were complex, was to push to higher doses and also to push to greater weight loss. Tough to answer in a single study. With the fixed dose combination with petrelintide and 388, obviously Phase II data will provide us the necessary information to understand which doses can optimize the clinical response, but balancing what Adam and I have both referred to, which is the tolerability and acceptability profile of each asset.

Better tolerability of the amylin based therapy, while still having adequate or optimized doses of 388. So that is our current strategy pending all of US having line of sight for the phase two dosing data and then finally, creating a simplified a dose escalation scheme as possible. So you don't have multiple.

Doses or changes obviously this is intended as a fixed dose co formulated asset so phase II will teach us a great deal great question and more to follow ambition.

Great. Thank you so much.

Thank you.

We will take our next question.

Your next question comes from the line of Prakash Aqua from capital. Please go ahead. Your line is open.

Hi, Thank you so much we're taking my questions and congrats on the quarter. So maybe first.

Adam Steensberg: We are discussing multiple options, but instead of maximizing each, I would say our goal in Phase II will be to optimize each. We would anticipate that that is higher dose amyloid-based therapy, petrelintide, at the maximally effective doses. If it in fact remains as well tolerated as we've seen in the early phase trials, then adding what I'll call an optimized but not necessarily maximal dose of the Incoterm-based therapy to provide additional weight loss, glycemic control for those with diabetes, potentially cardiovascular risk reduction. So in discussions with our Roche partners, whether this will be, I'll call it a high petrelintide, low 388, high mid, or high high, I think we collectively in the alliance with Roche agree that if you go to high doses of both, you will achieve the greatest weight loss.

This is a massive disconnect between the stock price undervalue of petrol anti described by Roche during the deal I'm sure any level given that you have so much cash on hand.

Milestone from Roche next year with higher profit here, but you've been so why not consider something like a share buyback given the disconnect and if not share buyback could you consider BD in the metabolic disease space as there are many opportunities out there for example in China and then one clinical question coming out of the other question on the <unk>.

And what was the impact on CV and inflammation markers, which have been more modest compared with GOP ones, even for companies and government type. So I'm wondering your thoughts on the ECB inflammation data.

Both referred to, which is the tolerability and acceptability profile of each asset. Um, we are discussing multiple options but uh, instead of maximizing each, um, I would say our goal in Phase 2 will be to optimize each. I mean, we would anticipate that that is higher dose uh, amalyn, uh, based therapy Patrol and tied. Um, at the maximally affected effective doses. Um, if it in fact remains as well tolerated, as we've seen in the early phase trials while then adding what I'll call an optimized, but not necessarily maximal, dose of the incorrect and based therapy. Um,

Implications for petrol the entitlements.

Thank you.

Thank you.

I will take the first question and hand over to David for the second.

Remember that the announcement we announced.

The partnership with US in March and we closed in May is a historic and transformative partnership in that it's a true co development and co commercialization partnership it's not licensing agreement.

Adam Steensberg: But balancing that with an acceptability and tolerability profile where we think we can fully leverage the better tolerability of the amyloid-based therapy while still adding adequate or optimized doses of 388. So that is our current strategy pending all of us having line of sight to the Phase II dosing data. And then finally, creating as simplified a dose escalation scheme as possible so you don't have multiple doses or changes. Obviously, this is intended as a fixed dose co-formulated asset. So Phase II will teach us a great deal. Great question and more to follow, Andy.

We will have in order to realize the full potential of the 50% value and future profits of not only between side, but also the combination product of between <unk> and <unk> hundred 88.

Those have to carry our share.

Our shaft as development costs. So it is incredibly important for us to be well funded as a company to deliver on that.

Opportunity to have 50% of future profit from this partnership of.

Operator: Great, thank you so much.

Of course, we don't have to invest into manufacturing, which.

With rosh agree that if you go to high doses of both, you will achieve the greatest weight loss but balancing that with an acceptability and tolerability profile, where we think we can fully leverage, the better tolerability of the amalin based therapy while still adding adequate or optimized doses of 388. So that is our current strategy pending, um, all of us having a line of sight to the phase 2 dosing data. And then finally, you know, creating a simplified a dose escalation scheme as possible. So you don't have multiple doses or changes. Obviously, this is intended as a fixed dose co-formulated asset. Um, so, uh, Phase 2 will teach us a great deal. Great question. And more to follow Andy.

Rhoda Raiden: Thank you. We will take our next question. Your next question comes from the line of Prakkar Agrawal from Kanto. Please go ahead, your line is open.

Great, thank you so much.

We will carry all the manufacturing investments, but we will have to carry our shaft development cost in the prelaunch costs.

Thank you.

We will take on next question.

So.

For me it is actually more important to make sure that we stay as well capitalized as possible. So we can deliver on our commitments into this partnership the last thing I wanted to do is to put <unk> in a position, where we cannot honor our financial obligations into the partnership.

David Kendall: Hi, thank you so much for the invitations and congrats on the quarter. First, there is a massive disconnect between the stock price and the value of petrelintide ascribed by Roche during the deal. I am sure you will agree with that. You have so much cash in hand and will have milestones from Roche next year with high probability of achievement. Why not consider something like a share buyback given the disconnect? If not share buyback, could you consider BD in the metabolic disease space as there are many opportunities out there, for example, in China? One clinical question coming out of ADA, the other question on the Kagri-Sema data was the impact on CV and inflammation markers, which were more modest compared to GLP-1s, even for Kagri-Sema and Kagri-Mentide. What are your thoughts on the CV inflammation data and implications for petrelintide when Supreme One reaches out?

Your next question comes from the line of praa AUA from Canto, please go ahead. Your line is open

So while we are extremely well capitalized. We also believe it is super important for us to be in a position, where we will continue to honor our obligations from a financial perspective and also recognizing that we are confident that we are an innovation company. We are a biotech company who have delivered.

Hi, uh, thank you so much for taking my questions and, uh, congrats on the quarter. So, maybe first, um, there's a massive disconnect between the stock price, and the value of petrol and tied ascribed by row during the deal. I'm sure you'll be with that and you have so much cash in hand. And we'll have Milestones from rosh next year with high probability of achievement. So why not consider something like a shared buyback? Given the disconnect and if not shared by back, could you consider BD in the metabolic TV space? As there are many opportunities.

Again, and again, great innovations, we do expect to continue to invest in the rest of the pipeline to deliver on our ambition to become a leading player in the PC space and the associated diseases. We think we have a significant opportunity to leverage our 25 years of expertise and experience.

David Kendall: Thank you.

Adam Lange: Thank you, Prakkar. I will take the first question and hand over to David for the second. Remember that the partnership with Roche, which we announced in March and closed in May, is a historic and transformative partnership in that it is a true co-development and co-commercialization partnership. It is not a licensing agreement. We will have, in order to realize the full potential of the 50% value and future profits of not only petrelintide, but also the combination product of petrelintide and CT388, we both have to carry our share or cover our share of the development costs. So it is incredibly important for us to be well-funded as a company to deliver on that opportunity to have 50% of future profit from this partnership.

And peptide drug discovery and development.

Out there for example in China and then 1 clinical question coming out of ADA, the other question on the data, was the impact on CV and inflammation markers, which were more modest compared to GOP ones, you know, even for cab and type. So what are your thoughts on these CV? Inflammation data and implications for petroleum type and supreme 1 reads out. Thank you.

And tap into these unique opportunities that are now.

Two in obesity and all of these related diseases. So.

Thank you. I will take the first, uh, question and and hand over to to David for the second. Um,

So you should not expect a share buyback program from C&I.

And the next question, David I'll hand over to you.

Thank you Adam and per car.

Very important question and we saw work to you and others did.

remember that the announcement we announced, uh, the partnership with Ross in in March, and we closed in in May is a historic and transformative partnership. In that it's a true co-development and co-commercialization partnership, it's not Rising agreement.

Tegra data.

I will simply state that while amylin based therapies clearly are not <unk> based therapies GOP ones who've demonstrated.

Cardiovascular risk reduction in both diabetes and obesity likely have clear trophic effects due to receptors on multiple tissues.

We will have in order to realize the full potential of the 50% value and and future profits of not only between side but also the combination product of between side and CC. 388 we always have to carry our share

The both the magnitude and direction of CVA risk markers.

Or cover our share of the development costs. So it is incredible important for us to to be well funded as a company to deliver on that.

For us in our early Phase program with limited data them, a broader category program, including their phase III Readouts.

Adam Lange: Of course, we do not have to invest into manufacturing, as Roche will carry all the manufacturing investments, but we will have to carry our share of the development cost and the pre-launch cost. So for me, it is actually more important to make sure that we stay as well-capitalized as possible so we can deliver on our commitments into this partnership. The last thing I want to do is to put Zealand Pharma A/S in a position where we cannot honor our financial obligations into the partnership. So while we are extremely well-capitalized, we also believe it is super important for us to be in a position where we can continue to honor our obligations from a financial perspective. Also recognizing that we are a company, we are an innovation company, we are a biotech company who have delivered again and again great innovations.

Opportunity to have 50% of future profit from this partnership.

Still demonstrated directionally, what we consider very positive ever.

Of course, we don't have to invest into manufacturing, which US will carry all the manufacturing Investments, but we will have to carry our share of the development cost and the pre-launch cost.

Evidence that blood pressure.

so,

Potentially markers of inflammation.

<unk>.

And body weight, all three very important determinants of CV risk. There is also a non clinical evidence of the direct effects of.

Mmm agonism.

On cardiac tissues, not through receptors, but likely through other mechanisms either through <unk> or through body weight reduction.

For me, it is actually more important to make sure that we stay as well capitalised as possible so we can deliver on our commitments into this partnership. The last thing I want to do is to put sealant in a position where we cannot honor our financial applications into the partnership.

So in our mind.

Adam alluded to.

We are not looking to go toe to toe with GOP ones.

We are looking to develop a unique class with unique benefits.

Adam Lange: We do expect to continue to invest in the rest of the pipeline to deliver on our ambition to become a leading player in the obesity space and the associated diseases. We think we have a significant opportunity to leverage our 25 years of expertise and experience in peptide drug discovery and development and tap into these unique opportunities that are now coming through in obesity and all these related diseases. So you should not expect a share buyback program from Zealand Pharma A/S. On the next question, David, I will hand over to you.

I discussed at our recent fireside chats.

One sure way not to get cardio protection from GOP, one based therapy will be that you cannot take it or will not take up due to tolerability issues.

So we strive to leverage.

So while we are extremely well capitalized, we are also believe it is super important for us to be in a position where we can continue to uh honor our obligations from our financial perspective and also recognizing that we are a company, we are an innovation company, we are about the company who have delivered again and again, great Innovations. We do expect to continue to invest in the rest of the pipeline to deliver on our ambition, to become a leading player in the Obesity space and the associated diseases. We think we have a significant opportunity to leverage our 25 years.

Our data with patrolling died.

The program.

<unk> cardiovascular outcomes to determine if Amazon based agonist with these improvements in risk markers cannon, well as we would have hypothesized to reduce cardiovascular risk.

Of expertise and experience in peptide, drug Discovery and development. And and tap into these unique opportunities that are now coming true in obesity and all these related diseases. So, so you should not expect a share buyback program from Cain.

Yes, lesser magnitude, but to us both directionally more broadly across clinical programs evidenced.

Adam Steensberg: Thank you, Adam and Prakkar. A very important question, and we saw what you and others did in the Kagri data. I will simply state that while amyloid-based therapies clearly are not GLP-1-based therapies, GLP-1s have demonstrated cardiovascular risk reduction in both diabetes and obesity, likely have pleiotropic effects due to receptors on multiple tissues. Both the magnitude and direction of CV risk markers for us in our early phase program with limited data in the broader Kagri program, including their Phase II readouts, still demonstrate directionally what we consider very positive evidence that blood pressure, potentially markers of inflammation, and body weight, all three very important determinants of CV risk. There is also non-clinical evidence of direct effects of amylin agonism on cardiac tissues, not through receptors, but likely through other mechanisms, either through vagal afferents or through body weight reduction.

And on the next question, David, I will hand over to you.

Cardiovascular risk markers all trend in the direction that will support cardio protection from Amazon based therapies, including patrolling Todd.

Thank you.

Thank you.

We will take our next question.

Your next question comes from the line of Savannah, Chen from Wells Fargo. Please go ahead. Your line is open.

Hi, Thanks for taking my question. So I wanted to ask what you think is the real addressable market opportunity for patients who cannot tolerate coupon since we've heard anecdotally from doctors that discontinuation due to tolerability is fairly low and much less than that 60% discontinuation.

Within one year, that's commonly cited.

Program with limited data and the broader keg reprogram, including their Phase 2 readouts um uh still demonstrate directionally what we consider very positive, uh, evidence that blood pressure. Um, potentially markers of inflammation. Um,

With curious perhaps quite your market research indicates is the real discontinuation rate from the more current coupons like kind of a glitch had interest appetite. Thank you.

Thank you for the question.

I think it's <unk>.

Number one I think we have clearly witness that once these molecules.

Utilize in a clinical setting.

Adam Steensberg: In our mind, and as Adam alluded to, we are not looking to go toe-to-toe with GLP-1s. We are looking to develop a unique class with unique benefits. You and I discussed at a recent fireside chat that one sure way not to get cardio protection from GLP-1-based therapy will be that you cannot take it or will not take it due to tolerability issues. So we strive to leverage our data with petrelintide and the program looking at cardiovascular outcomes to determine if amylin-based agonists with these improvements in risk markers can and will, as we would hypothesize, reduce cardiovascular risk. Yes, lesser magnitude, but to us, both directionally and more broadly across clinical programs, evidence that cardiovascular risk markers all trend in the direction that will support cardio protection from amylin-based therapies, including petrelintide.

Sometimes less experienced prescribers these continue right.

Continuation rate remains very high I think David alluded to another extremely important question and that is around acceptability remember right. Now we are in a world where there's so much furnaces. So.

And at least.

Yeah.

One opportunity of one one situation, we could be and is that people are actually ready to accept more side effects than if there wasn't a tentative imagine a world whether it would be an alternative which would provide the same degree of weight loss, but where you have less gi side effects.

Uh, and body weight. All 3, very important determinants of CV risk. Um, there's also non-clinical evidence of Direct effects of, uh, Amal and agonism. Um, on, uh, cardiac tissues, um, not through receptors, but likely through, uh, other mechanisms either through veal afference, um, or through body weight reduction. Um, so we in our mind, uh, and as Adam alluded to, um, we are not looking to go Toe to Toe with GOP 1's. Uh, um, we are looking to develop a unique class with unique benefits, uh, you and I discussed at a recent fireside chat that, um, 1 sure way not to get cardio protection from a GOP. 1-based therapy will be that you cannot take it or will not take it due to tolerability issues. Uh, so, uh, we strive to leverage, um, uh, our data with petrol and died. Um, and the program, uh, looking at cardiovascular outcomes, uh, to determine if, uh,

Q2, not Lucia appetite and your interest in food, but more fearful faster.

And thus can enjoy.

<unk> events around food I think history has shown us that people.

Once they have choices will actually go for those choices and if the <unk> is people who are ready to accept less than if there is only one solution.

So we are quite firm not only considering the discontinuation rates we have seen today.

Adam Lange: Thank you.

An amylon-based agonist with these improvements in risk markers can and will, as we would hypothesize, reduce cardiovascular risk. So, yes, lesser magnitude, but to us, both directionally and more broadly across clinical programs, evidence shows that cardiovascular risk markers all trend in the direction that will support cardioprotection from amylon-based therapies, including Patrol and Tied.

Rhoda Raiden: Thank you. We will take our next question. Your next question comes from the line of Serena Shen from Wells Fargo. Please go ahead, your line is open.

Thank you.

But also anticipating that if there isn't more total approach.

Thank you. We will take on next question.

Except ability would actually drop even further for the current therapies in our.

Unknown Operator: Hi, thanks for taking my question. I wanted to ask what you think is the real addressable market opportunity for patients who cannot tolerate GLP-1, since we've heard anecdotally from doctors that discontinuation due to tolerability is fairly low and much less than that 60% discontinuation within one year that is commonly cited. I am curious perhaps what your market research indicates is the real discontinuation rate from the more current GLP-1s, like semaglutide and tirzepatide. Thank you.

The ambition to precision Petrie inside is a huge a foundational therapy for those patients who wants to potentially to have a more pleasant weight loss experience.

Your next question comes from the line of Serena Shen from Wells, Fargo, please go ahead. Your line is open

If we can continue to deliver on the data that we've seen thus far with this molecule.

Thank you.

Thank you.

We will take our next question.

Your next question comes from the line of he had Lee from Barclays. Please go ahead. Your line is open.

Adam Lange: Thank you for the question. I think it is number one, we have clearly witnessed that once these molecules are utilized in a clinical setting with perhaps sometimes less experienced prescribers, discontinuation rate remains very high. I think David alluded to another extremely important question, and that is around acceptability. Remember that right now we are in a world where there are no alternatives. At least one opportunity or one situation we could be in is that people are actually ready to accept more side effects than if there was an alternative. Imagine a world where there would be an alternative which would provide the same degree of weight loss, but where you have less GI side effects, where you do not lose your appetite and your interest in food, but more feel full faster. Those can enjoy social events around food.

Hi, Yeah from Barclays. Thank you for taking my question.

Hi, thanks for taking my question. So I wanted to ask what you think is the real addressable Market opportunity for patients, who cannot tolerate clip, 1 since we've heard anecdotally from doctors that discontinuation due to tolerability, is fairly low and much less than that. 60% is continuation within 1 year, that's commonly cited, um, with curious, perhaps, what your Market Research indicates is the realest continuation rate from the more current clip ones like some glue ties in to set time. Thank you.

So I have two the first one is on ethylene pie.

Thank you for the question. And I think it's

Okay. Thanks, Paul sharing the baseline data so I heard based on our very quick calculation. According to what is the pattern impact shelf space.

Today's Wednesday, it seems like based on your.

Okay Sharon baseline.

Herculean task with Ashford, Inc.

And Christian with malls I think 16.

Graham trial after the testing.

Number 1. I think we have clearly witnessed that once these molecules are utilized in a clinical setting with perhaps, um, sometimes less experienced prescribers, discontinuation rates remain very high. I think David alluded to another extremely important question, and that is around acceptability. Remember, right now, we are in a world where there's no alternative. So,

You May also know they show a baseline yanai.

at least a a

So now with the titration schedule. So I think it's easy to think that we promise to which they call the like.

Hey, Ron just mentioned 2015 with loss at 42 weeks.

Curious is there something you are looking for and also could you. Please remind us what kind of penetration and share in the top line in the first half of next year and we should expect and that's your call.

1 opportunity or 1 1 Scituate, more side effects than if there was an alternative, imagine a world where it would be an alternative, which would provide the same degree of weight loss, but where you have less EI side effects where you do not lose your appetite and your interest in food, but more fruitful faster.

Adam Lange: I think history has shown us that people, once they have choices, will actually go for those choices. If there are choices, people are ready to accept less than if there is only one solution. We are quite firm, not only considering the discontinuation rates we have seen today, but also anticipating that if there is a more tolerable approach, acceptability would actually drop even further for the current therapies in our ambition to position petrelintide as a future foundational therapy for those patients who want to potentially have a more pleasant weight loss experience if we can continue to deliver on the data that we have seen thus far with this molecule. Thank you.

Right.

And the second one I think it's kind of like a follow up is kind of like that.

And thus can enjoy social events around food. I think history have shown us that people

Yes, I think I said Europe any tasteful the admin costs.

We saw at <unk> and I think we'll be.

Once they have choices will actually go for those choices and if there are choices, people are ready to accept less than if there is only 1 solution.

Finally, one trial from novel Catherine didn't hide how does relatively no recalls.

So, we are quite firm. Not only considering the discontinuation rates we have seen today.

Rob.

Multiple weeks.

So niccolo tied all cap pharma actually showed a very clear continue with multiple third party.

but also anticipating that if there isn't more tolerable approach, acceptability would actually drop even further for the current Therapies in in our

So there are some concerns are more of a question Mark for me like how Amylene class mate.

Uh, ambition to position opportunity, as a Future Foundation of therapy, for those patients.

I don't know its like strong Ernie.

With loss.

How does the efficacy may potentially when stock turn.

Who wants to potentially have a more pleasant weight loss experience. Um, if we can continue to deliver on the data that we have seen thus far with this molecule.

One is all the time so just curious how should we think about this with Lockheed up indicate.

Thank you.

Rhoda Raiden: Thank you. We will take our next question. Your next question comes from the line of Yihan Li from Bacchus. Please go ahead, your line is open.

Thank you very much.

Thank you. We will take our next question.

Thank you for your question and maybe I'll just answer quickly. So we've actually quite impressed to see concrete entitled the dose of two four milligram delivering close to 12% weight loss and a 68 week study because we consider two four milligram of Katrina, we didn't have to be a very low dose of.

Henriette Wennicke: Hi, Yihan from Bacchus. Thank you for taking our questions. I have two. The first one is on petrelintide. Again, thanks for sharing the baseline data. Based on our very quick calculation, according to what the petrelintide showed in Phase 1B, it seems like based on today's shared baseline data, petrelintide could potentially reach around 10% weight loss at week 16 in the Zoom trial after adjusting male-female ratio, baseline BMI, and the slow titration schedule. I think it is indicating very promising to reach the goal of around 13% to 15% weight loss at 42 weeks. I am just curious, is this something you are looking for? Also, could you please remind us what kind of parameters you will share in the top line in the first half of next year? We should expect an investor call for the PR, right? The second one is a follow-up.

Your next question comes from the line of Yee. Hanley from barkas, please go ahead. Your line is open.

Compared to the nine milligrams, we are testing now with much higher of our amylin analogue with much higher bioavailability.

At least at one comparison I think if you consider utilizing a very low dose of <unk>. One you would also at one point and see that that would not continue to be weight loss.

So we are excited about the potential for us to test even higher doses of.

Of course as you also alluded to we would expect higher doses to provide more weight loss and thus also the ability to achieve longer term continuous way tools.

We of course as David also alluded to in his prepared remarks.

This 1 B, it seems like based on your, uh, like the today's shared baseline data is impacting type could potentially reach a strong like 10% with loss at Big 16 in the Zoom premium trial. After adjusting, you know, male-female ratio, baseline VMI, and you know, slow, slow.

Uh huh.

Very aware of the fact that in general women are females lose more weight. In these studies, then mills and we had only around 20% in our phase one studies now would be just around 60% females in the upcoming phase III and.

Henriette Wennicke: It is about the efficacy durability for the amyloid-based therapies. We saw at ADA, the Redefine 1 trial from Novo, the Cagri-Linktide had a relatively slow weight loss from around 44 weeks versus semaglutide. Cagri-Sema actually showed a very clear continued weight loss post 44 weeks. There are some concerns or more of a question mark for me, like how amyloid-based therapies may produce strong early weight loss, but the efficacy may potentially wane faster than the GLP-1s over time. I am just curious, how should we think about this weight loss durability of the amyloid-based therapies? Thank you very much.

And most often people report from their phase III trials around 60 to 65 up to 70% females. So.

Curious, is this something you are looking for? And also, could you, please remind us. What kind of parameters, you will share in the Top Line in the first half of next year and we should expect an investor call Post the pr, right? Um, and the second 1 actually is kind of like a follow up. It's kind of like, you know, that your the efficacy durability for the M class.

As of course, an opportunity here just the trial design and the inclusion of patients into these studies can help on the numbers what we are.

<unk> has done is to achieve and weight noticed that hits that.

Of around 50% to 20% weight loss and the most pleasant way for a patient.

So we see.

Somehow refused to be into maybe tightened numbers game as long as we are confident that based on our 28 and 42 weeks data that we can achieve that 15% to 20% wage hours in a phase III study.

So because we saw at ABA like the redefine 1 trial from Novo, the tracking type had a relatively slow weight loss from around 444 weeks, uh, versus a low tide or category. Some are actually showed very clear continued. Weight loss, post 44 weeks, so there are some concerns or more of a question. Mark for me, like, how amling class May produce? I don't know. It's like strong early weight loss. Um, but the

And we had a very pleasant experience and less side effects, we will be extremely bullish for the opportunity for <unk>.

Thank you.

Adam Lange: Thank you for your question. Maybe I will just answer quickly. We were actually quite impressed to see Kagri-Linktide at the dose of 2.4 milligrams, delivering close to 12% weight loss in a 68-week study. We consider 2.4 milligrams of Kagri-Linktide to be a very low dose of amylin compared to the 9 milligrams we are testing now with much higher of our amylin analog with much higher bioavailability. At least as one comparison, I think if you considered utilizing a very low dose of a GLP-1, you would also at one point see that there would not continue to be weight loss. We are excited about the potential for us to test even higher doses. As you also alluded to, we would expect higher doses to provide more weight loss, and thus also the ability to achieve longer-term continuous weight loss.

Thank you so much.

But the efficacy May potentially win faster than the JP once over time. So just curious, how should we think about this with lost durability of the AMI club? Thank you very much.

Thank you.

We will take our next question.

If I could also ask participants to limit yourself to one question only for the interest of time and your next question comes from the line of Sophie Grace Nissan from Jpmorgan. Please go ahead. Your line is open.

Good afternoon. Thanks for taking my question could you provide any updated thoughts on how you see the opportunity and much more R&D in light of the upcoming software data that well see what the potential label expansion for <unk> in the U S. In the second half.

Thank you for that question and I think it's highly relevant.

We have also tried to indicate in our call today, I think perhaps people do not ascribe significant and enough.

Adam Lange: We, of course, as David Kendall also alluded to in his prepared remarks, are very aware of the fact that in general, women or females lose more weight in these studies than males. We had only around 20% in our Phase 1 studies. Now it would be just around 50% females in the upcoming Phase 2. Most often people report from their Phase 3 trials around 60% to 65%, up to 70% females. There is, of course, an opportunity here that just the trial design and the inclusion of the patients into these studies can help on the numbers. What we are firmly focused on is to achieve a weight loss that hits that bar of around 15% to 20% weight loss in the most pleasant way for a patient.

Thank you for your question and maybe I'll just answer quickly. So we were actually quite impressed to see that the dose of 2.4 Mig delivering close to 12%. Weight loss in a 60 8 week study because we considered 2.4 migram of to be a very low dose of of allene compared to the 9 milligrams. We are testing. Now with with much higher of our amine analog with Much Higher by availability and at least, as 1 comparison, I think, if you considered utilizing a very low dose of a T1, you would also at 1 Point, see that there would not continue to be weight loss. Um, so we are excited about the potential for us to test even higher doses. As as, of course, as you also alluded to we, we would expect higher doses to provide more weight loss and uh and thus also the ability to achieve longer term continuous weight loss.

You and I will see you can say opportunity around distributor side franchise I think.

We still need to realize most people still need to realize that up to 35% of obese individuals have some degree of Nash. It is one of the most underserved consequences of living with Nash and we only have one FDA approved treatment for these which provided around 11%.

EES in fibrosis without worsening of <unk>. If you look into the data that I have presented last year in mass, which sort of tied as they themselves describe this groundbreaking we will accrete to that it was approaching 40% reduction in fibrosis without worsening of <unk>.

We are we, of course, as David also alluded to in his prepared remarks, uh, uh uh, very aware of the fact that in general, women or females, lose, more weight in these studies than than males. And we had only around 20% in our Phase. 1 Study is now would be just around 50% females in in the upcoming Phase 2 and most often people report from their face, 3, trials, around,

60 to 65 up to 70% females. So that's, of course, an opportunity here, that just the trial design. And the inclusion of the patients into these studies can help on the numbers. What we are?

And then I would say that we're looking at something that can truly change the needed for those patients who live with that condition or at risk for that I think if you look into the phase III program that are.

Adam Lange: We somehow refuse to be into a very tight numbers game as long as we are confident that based on our 28 and 42 weeks data that we can achieve that 15% to 20% weight loss in a Phase 3 study. With a very pleasant experience and less side effects, we will be extremely bullish for the opportunity for petrelintide. Thank you.

Investing in mesh wishes in at least to our knowledge is by far the largest program not only targeting as two and three but also cirrhotic patients, including very strong commitments to follow these patients until clinical outcomes.

That's a testament to also bring his belief in their ability to.

Firmly focused on is to achieve a weight loss that hits that uh bar of around 15 to 20% weight loss in the most Pleasant way, for a patient. So we we somehow refuse to be into a very tight number game. As long as we are confident that based on our 28 and 42 weeks days so that we can achieve that 15 to 20% weight loss in a phase 3 study. We we with a very pleasant experience and left side effects. We will be extremely bullish for the opportunity for patient side.

Henriette Wennicke: Thank you so much.

Thank you.

To differentiate too tight.

Thank you so much.

Rhoda Raiden: Thank you. We will take our next question. If I could also ask participants to limit yourselves to one question only for the interest of time. Your next question comes from the line of Sophia Graef Bull-Nielsen from JP Morgan. Please go ahead, your line is open.

Into this and provide a treatment option for these patients that can make a meaningful clinical impact.

Thank you.

We will take our next question.

Okay.

Thank you.

Yeah.

Thank you.

We will take our next question.

Your next question comes from the line of Benjamin Jackson from Jefferies. Please go ahead. Your line is open.

External Analyst: Good afternoon, thanks for taking my question. Could you provide any updated thoughts on how you see the opportunity in mass, not only in light of the upcoming survodutide data, but also with the potential label expansion for Wegovy in the U.S. in the second half?

If I could also asked participants to limit yourselves to 1 question, only for the interest of time. And your next question comes from the line of Sophia Grace bull Nissan from JP Morgan. Please go ahead, your line is open.

Great. Thanks for the question I'll keep it sure Adam I mean, specifically for you here I guess, we've seen recently.

Market <unk> develop to expand in our cash processing in a DTC setting I think previously we've.

Adam Lange: Thank you for that question. I think it is highly relevant. It is, as we have also tried to indicate in our call today, I think perhaps people do not ascribe significant and enough value. Also, you can say opportunity around the survodutide franchise. I think we still need to realize, most people still need to realize that up to 35% of obese individuals have some degree of NASH. It is one of the most underserved consequences of living with NASH. We only have one new FDA-approved treatment for these, which provided around 11% ease in fibrosis without worsening of NASH. If you look into the data that Boehringer Ingelheim have presented last year in NASH with survodutide, as they themselves described as groundbreaking, we will agree to that it was approaching 40% reduction in fibrosis without worsening of NASH.

<unk> had questions about whether you think that the obesity market as it could get to a state where it could be OTC and this is probably one of the closest stops you can get towards that so im wondering what youre thinking here in terms of Amazon and how you could whether you believe that is something you can position and our cash processing in the future or is very much.

Good afternoon. Thanks for taking my question. Um, could you provide Eddie updated thoughts on how you see the opportunity in Mash, not only in light of the upcoming survey data, but also with the potential label expansion for GOI in the US in the second half,

Thank you for that question. And I think it's, it's highly relevant. It's, you know, as we have also tried to indicate in our call today, I think perhaps people do not describe significant or and enough value, and also, you can say opportunity around the server side franchise, I think.

Focusing on our long term.

Long adherence population of market.

Any thoughts or any changes in the way youre and visited the market developing that would be great. Thank you.

Thank you for that question and I think as you alluded to it is of course something that we have been following closely and we have also been PAA P&L statements around this in order to ultimately address the obesity pandemic and all the diseases that follows we'd need novel ways to get these patients to enter these products to patients.

Quences of living with with mesh and we only have 1 U, FDA approved treatment for these which provided around 11%. Um,

And direct to consumer once you have enough safety.

Adam Lange: Then I would say, then we are looking at something that can truly change the needle for those patients who live with that condition or are at risk for that. I think if you look into the Phase III program that Boehringer Ingelheim are investing in NASH, which is to our knowledge, by far the largest program, not only targeting F2 and 3, but also cirrhotic patients, including very strong commitments to follow these patients onto clinical outcomes. That is a testament to also Boehringer Ingelheim's belief in their ability to differentiate survodutide into this and provide a treatment option for these patients that can make a meaningful clinical impact. Thank you.

<unk> experienced around them is one way to go for sure the cash market.

I think we're already now seeing how important it is maybe people have been surprised how fast that has moved.

But I don't think anyone could.

Honestly question, if it would come because we know how interested patients and getting on these treatments and the willingness to pay for these treatments has also been clear for a long time. So it's just a matter of how fast it comes and it really opens unique opportunities.

Ease in fibrosis without worsening of, of mesh, if you look into the data that ber have presented last year in Mass with several tied, as they themselves described as groundbreaking, we will agree to that. It was approaching 40%, uh, reduction in fibrosis without worsening of of of mesh. And then I would say, then we are looking at something that can truly change the needle for those patients, who live with that cons condition, or at risk for that. I think if you look into the phase 3 program, that ber are investing in in mesh, which is in at least 2 our knowledge, by far the largest program not only targeting F2 and 3 but also cirrhotic patients including very strong commitments to follow these patients on to clinical outcomes

For for companies like Us and the loss as we entered the market but of course, it's something we'll have to discuss and plan for.

that's a testament to also bring us belief in their ability to

If you look at our profile like the one we have booked between I would say that of course lends itself extremely well into that segment. If it turns out that it is an ECS prescription is an easier product to be on and it will deliver the patients they wait till the pace and looking forward. So I don't see a disconnect between <unk>.

to differentiate server side uh um into this uh and provide a treatment option. For these patients that can make a meaningful clinical impact

Thank you.

Rhoda Raiden: Thank you. We will take our next question. Your next question comes from the line of Benjamin Jackson from Jefferies. Please go ahead, your line is open.

Thank you.

We will take our next question.

External Analyst: Thanks for the question. I will keep it short. Adam, specifically for you here, I guess we have seen recently the market in the GLP-1 sense develop to expand in a cash-pay setting and a DTC setting. I think previously you have had questions about whether you think that the obesity market ever could get to a state where it could be OTC. This is probably one of the closest steps you can get towards it. So I am wondering what you are thinking here in terms of petrelintide and whether you believe that is something you can position in a cash-pay setting in the future or is very much your focus being on a long-term, long adherence population and market. Any thoughts or any changes in the way you envision the market developing, that would be great. Thank you.

Schumer payments and then long term staying on treatment for long term.

Your next question comes from the line of Benjamin. Jackson from Jeffrey's, please go ahead. Your line is open

Do you think a lot of patients would be willing to also pay for staying on treatment as long as they weight loss and weight maintenance experience is one which they will accept.

Thank you for the question.

Thank you.

We will take our next question.

Our question comes from the line of Julian Harrison.

Please go ahead your line is open.

Hi, This is ray on for Julien. Thank you for taking our questions you mentioned the value out of banks and the importance of quality.

You would like to see on body composition, and new prime or is less lean mass loss relative to existing therapies enough to translate into your preference in practice.

Adam Lange: Thank you for that question. As you alluded to, it is, of course, something that we have been following closely. We have also been clear in our statements around this. In order to ultimately address the obesity pandemic and all the diseases that follow us, we need novel ways to get these products to patients. Direct-to-consumer, once you have enough safety and experience around them, is one way to go for sure. The cash-pay market, I think we are already now seeing how important it is. Maybe people have been surprised how fast it has moved. I do not think anyone could honestly question if it would come because we know how interested patients are in getting on these treatments. The willingness to pay for these treatments has also been clear for a long time. So it is just a matter of how fast it comes.

Great. Thanks for the question. I'll keep it short. Um, Adam, I mean specifically for you here, I guess we've seen recently the the market in the jlp 1 cents developed to expand in a cash, pay setting and a DTC setting. I think previously we've you know you've had questions about whether you think that the Obesity Market ever could get to a state where it could be OTC. And this is probably 1 of the closest steps you can get towards it. So, I'm wondering what you're thinking here in terms of amalyn and how you could, whether you believe that is something you can position in a cash pay setting in the future or is very much, uh, your your focus being on a long term, uh, long adherence, uh, population and market. And so any, any thoughts or any changes in the way you envisioned the market developing? That would be great. Thank you.

Thank you for your question, we cannot provide a specific number I would say is as David also alluded to any weight loss program will be associated with some degree of muscle those because you carry less weight, but we would be looking for in our program is of course that we don't have accentuated muscle wasting as we may have seen.

With some of the TLC once when you lose weight too fast and to.

Dramatic.

Getting into a very negative energy balance.

Thank, thank you for that question. And I think as you alluded to it is, of course, something that we have been following closely. And we have also been clear here in our statements around this, in order, to ultimately, address the Obesity pandemic, and all the diseases that follows we need novel ways to get these patients to these products to patients, uh, and direct to Consumer. Once you have enough safety and and, and experience around them is 1 way to go for sure, the cash Market

We are reducing and increasing your insulin levels et cetera. So we are probably it's too early to provide a number but healthy weight loss for us is one way at least not accentuate the muscle wasting doing the wafers.

I think we already now seeing how important it is, maybe people have been surprised how fast it has moved.

Um, but I don't think anyone could.

Thank you.

Thank you.

Adam Lange: It really opens unique opportunities for companies like us and Roche as we enter the market. Of course, it is something we will have to discuss and plan for. If you look at a profile like the one we have for petrelintide, I would say that, of course, lends itself extremely well into that segment if it turns out that it is an easier prescription, it is an easier product to be on. It will deliver the patients, the weight loss that patients are looking for. So I do not see a disconnect between consumer payments and then long-term staying on treatment for a long term. I actually think a lot of patients would be willing to also pay for staying on treatment as long as their weight loss and weight maintenance experience is one which they will accept. Thank you for the question.

We will take our next question.

The question comes from the line of Jacob Macau from KBC Securities. Please go ahead. Your line is open.

Hi, there and thanks for taking my question.

A question on the phase II trial for tapping to inspired and obesity names.

And the second half of this year can you share what that condition would be and given that there are multiple obesity obesity lung diseases that you can pick from could you walk us through the criteria that you used to say that that indication.

Thanks for your question and it's probably one quarter too early to share the specific indications but.

We will come back.

And not that distinct future, but clearly for us it's about differentiation, we don't want to be among those companies who can develop undifferentiated.

Operator: Thank you.

Rhoda Raiden: Thank you. We will take our next question. The question comes from the line of Julian Harrison from PDIG. Please go ahead, your line is open.

Honestly question if it would come because we know how interested patients are in getting on these treatments and the willingness to pay for these treatments has also been clear for a long time. So it's just a matter of how fast it come and it really opens unique opportunities, uh, for for, for, for companies like us and Ross, as we enter the market. But, of course, it's something we have to discuss and, and plan for. But, uh, if you look at the profile, like the 1 we have for between, I would say that. Of course, lens is self extremely well into that segment. If it turns out that it is an easier prescription, it is, is an easier product to be on and it will deliver the patients, the weight loss. The pages are looking for. So I don't see a disconnect between consumer payments and then long term, staying on treatment for a long term. I actually think a lot of patients would be willing to also pay for staying on treatment as long as their weight loss and weight maintenance experiences is 1 which they will accept. Thank you for the question.

Thank you.

Thank you. We will take our next question.

Weight loss agents that do not make a true difference for patients.

Unknown Operator: Hi, this is Rayan for Julian. Thank you for taking our questions. You mentioned the value-add effects and the importance of weight loss quality. Is there a number you would like to see on body composition in petrelintide, or is less lean mass loss relative to existing therapies enough to translate into preference in practice?

And the question comes from the line of Julian. Harrison from PD IG, please go ahead. Your line is open.

Okay. Thank you.

Thank you.

Test of time, we have one final question.

And the final question comes from the line of Carsten Madsen.

<unk> from <unk>. Please go ahead your line is open.

Adam Lange: Thank you for your question. We cannot provide a specific number. I would say, as David also alluded to, any weight loss program will be associated with some degree of muscle loss because you carry less weight. What we would be looking for in our program is, of course, that we don't have exaggerated muscle wasting, as we may have seen with some of the GLP-1s when you lose weight too fast and too dramatic, getting into a very negative energy balance and increasing your insulin levels, et cetera. So it's too early to provide a number, but healthy weight loss for us is one which at least does not exaggerate the muscle wasting during the weight loss. Thank you.

Hi, this is Rayon for Julian. Thank you for taking our questions. Um, you mentioned the value-add effects and the importance of weight loss quality. Is there a number you would like to see on body composition in Supreme, or is less lean mass loss relative to existing therapies enough to translate into preference and practice?

Thank you very much for taking my question I just had a question to slide 10, where we show this.

The data was quite impressive weightless further females in the trial.

But at the same time isn't it also a little bit concerning to you that you see maybe no. Additional response, maybe even less response in the main part of the trial.

Doubling the dose from four eight to nine milligram.

Interesting to hear your view on this.

I mean, David I don't know if you have further comments to this one but number one remember a small data set it could be.

We don't know what doses are the right ones and that is what we saw in phase II. Even if you look at the mid dose or the four five milligram dose. If you look at those numbers you can see that could of course deliver the weibo's. We're looking for also in the long term study Thats why we are entering the phase.

Unknown Operator: Great, thank you.

Rhoda Raiden: Thank you. We will take our next question. The question comes from the line of Jacob McKell from KBC Securities. Please go ahead, your line is open.

Thank you.

Great. Thank you.

Thank you. We will take our next question.

The sensor rich dose finding in phase III, when we looked into the early responses in phase one study there was a tendency for differences.

And the question comes from the line of Jacob muyl from KBC Securities. Please go ahead. Your line is open

David Kendall: Hi there, and thanks for taking my question. I have a question on the Phase II trial for dapiglutide in an obesity-linked condition in the second half of this year. Can you share what that condition would be? Given that there are multiple obesity-linked diseases that you can pick from, could you walk us through the criteria that you use to select that indication?

In how fast these people lost weight.

So we still.

I would say believed that the higher doses could provide more regardless of the.

Number in this.

Study suggested that the two highest doses were equally effective David any further comments, yes, I think two points Adam one.

Um, hi there. I'm just taking my question. I have a question on the Facebook trial for dappy glue side in an obesity linked, you know, condition in the second half of this year. Can you share what that condition would be and given that there are multiple obesity, obesity Ling, diseases that you can pick from. Could you walk us through the criteria that you use to select that indication?

Adam Lange: Thanks for your question. It is probably one quarter too early to share the specific indication, but we will come back in not that distinct future. Clearly, for us, it is about differentiation. We do not want to be among those companies who develop undifferentiated weight loss agents that do not make a true difference for patients.

Actually in this cohort four eight we saw this group lose weight at similar doses more quickly so that.

Thanks for your question, and it's probably 1 quarter too early to share the specific indication. But um

You may have actually overemphasized as Adam said in the small cohort.

<unk> to differentiate.

And you actually see in the two higher dose cohorts, particularly with the mind milligram. There are significant individual variation and a small data set.

We'll come back, um, not that distinct future. But, clearly for us, it's about differentiation. We don't want to be among those companies who develop on differentiated, uh, weight loss agents that do not make a true difference for patients.

David Kendall: Okay, thank you.

Rhoda Raiden: Thank you. In the interest of time, we have one final question. The final question comes from the line of Carsten Lamborn-Metzen from Danske Bank. Please go ahead, your line is open.

Okay, thank you.

<unk> provide you a number of questions, but doesn't provide that clarity I think 400, maybe plus participants in the full phase <unk> will be a better way to address that.

Thank you in the interest of time. We have 1, final question.

There has to be aware of is there cross weight loss approaches and that started in exercise as well as medical therapies women on enbridge lose $3 to 5% more body weight or.

David Kendall: Thank you very much for taking my question here. I just had a question to slide 10 where we share this gender data was quite impressive weight loss for the females in the trial. At the same time, isn't it also a little bit concerning to you that you see maybe no additional response or maybe even less response in the male part of the trial when doubling the dose from 4.8 to 9 milligrams? I was interested to hear your view on this.

and the final question comes from the line of Caston lambourne medson from thanks your bank, please go ahead, your line is open,

A year or more of exposure. So I think those are the things, we know where our agenda.

Balance on.

I think phase two will be a much more robust data set for us to address your question and the dose finding for us.

Excellent and then.

A small quick follow up to that one was.

Adam Lange: David, I do not know if you have further comments on this one, but number one, remember a small data set. It could be, again, we do not know what doses are the right ones. That is what we explore in Phase II. Even if you look at the mid-dose or the 4.5 milligram dose, if you look at those numbers, you can say that could, of course, deliver the weight loss we are looking for also in a long-term study. That is why we are entering such a rich dose finding in Phase II. When we looked into the early responses in Phase I study, there was a tendency for differences in how fast these people lost weight. We still would say believe that the higher doses could provide more regardless of the end number in this study suggested that the two highest doses were equally effective.

Thank you very much for taking my question here, I just had a question to slide 10, where I share this gender data was quite impressive weight loss for the females in the trial, um, but at the same time, isn't also a little bit concerning to you that, you see, uh, maybe no additional response or maybe even less response in the male part of the trial. Uh, when doubling the dose from 4.8 to 29 milligram, I was interested to hear your view on this.

Also part of my first question, but completely unrelated.

In terms of phase III trials, we have learned so much about the obesity space over the last.

I mean, David, I don't know if you have further comments to this 1, but number 1, remember a small data set,

52 weeks.

Moving rapidly all the time should.

Should we expect that Youre planning for sort of a classic phase III set up with the.

Overweight overweight diabetics et cetera.

it could be again, we don't know what doses are the right ones. That is what we explore in Phase 2. Even if you look at this mid dose or the 4.5 migram dose, if you look at those numbers, you can say

The room for some new phase III trials.

Maybe sort of the <unk>, where you could sort of differentiate pitri, even more versus what's on the months.

that could, of course, deliver the weight loss. We are looking for, also, in the long term study. That's why we are entering the phase, um, the the such a rich, those finding in Phase 2. When we looked into the early responses in the phase 1, Study there was a tendency for for differences. Um,

Okay. Thank you for your question there and these are super important.

In how fast these people lost weight. Um, so

<unk>, which we are discussing with US right now and we will we will have to wait a little bit to provide updates, but I would.

<unk> also say that since we are developing an alternative it's probably.

Adam Lange: David, any further comments?

Adam Steensberg: I think two points, Adam. One, actually, in this cohort, the 4.8, we saw this group lose weight at similar doses more quickly. That may have actually overemphasized, as Adam Steensberg said, in this small cohort, it is difficult to differentiate. You actually see in the two higher dose cohorts, particularly the 9 milligram, there is significant individual variation in a small data set that can provide you a number of questions, but does not provide the clarity. I think the 480 plus participants in the full Phase IIB will be a better way to address that. The other is to be aware that across weight loss approaches, that is diet and exercise as well as medical therapies, women on average lose 3% to 5% more body weight over a year or more of exposure. I think those are the things we weigh our gender balance on.

Super important just to get out there.

You don't need to as long as you provide the first alternative with a more pleasant.

Side effect profiles.

Most patients do not stay on therapy on the other ones today, So I don't need to go and convince the patients who stopped taking something and then get on your new treatment in those patients.

Who have been exposed to a tier one at the time, we launched it not be ideally one. So this focus on shifting and so on from being on a tier one to getting to another modality.

If an issue here because we know from market data that patients most patients in us Dan do you have the one for long time.

Okay great.

Great. Thanks, Thank you.

Yeah.

Yeah.

Thank you all for attending and for your questions. Today, we look very much forward to future announcements and updates and to connecting in the coming weeks and months.

We still would say believe that the higher doses could provide more regardless of the end number. And this uh, study suggested that the 2 high doses were equally effective David any further comments? Yeah, I think 2 points Adam 1 actually, in this cohort in the 4.8, we saw this group lose weight at similar doses more quickly. So that, um, may have actually overemphasized, as Adam said, in this small cohort, it's difficult to differentiate. Um, and you actually see in the 2, higher dose chords, particularly the 9 milligram there are significant individual variation. In in a small data set that can, um, provide you a number of questions but doesn't provide the clarity. I think the 480 plus participants in the full phase. 2B will be a better way to address that, um, the other is to be aware that there are cross weight loss approaches and that's diet and exercise as well as medical therapies with

Adam Steensberg: I think Phase II will be a much more robust data set for us to address your question and the dose finding for us.

David Kendall: Excellent. A small quick follow-up to that one, which is also part of my first question, but completely unrelated. In terms of Phase III trials, we have learned so much about the obesity space over the last 52 weeks that it is developing rapidly all the time. Should we expect that you are planning for a sort of a classic Phase III setup with overweight, overweight diabetics, et cetera? Or are there room for some new Phase III trials? I am thinking maybe sort of a GLP-1 naive or GLP-1 failures where you could sort of differentiate petrelintide even more versus what is on the market today?

Women on average lose 3 to 5% more body weight, or a year, or more of exposure. So, I think those are the things we weigh. Our gender, uh, balance on. And, uh, I think Phase 2 will be much more robust data set for us to address your question and the dose finding for us.

Adam Lange: Thank you for your question, Carsten. These are super important considerations, which we are discussing with us right now. We will have to wait a little bit to provide updates. I would also say that since we are developing an alternative, it is probably super important just to get out there. You do not need to, as long as you provide the first alternative with a more pleasant side effect profile. Most patients do not stay on a therapy on the GLP-1s today. So you do not need to go out and convince the patients to stop taking something and then get a new treatment. Most patients who have been exposed to a GLP-1 will, at the time we launch it, not be on a GLP-1.

Excellent. And then a small quick follow-up to that 1 which is uh also part of my first question. But completely unrelated. Um, in terms of phase 3 trials, we've learned so much about the Obesity space over the last uh, 52 weeks that it's developing rapidly all the time. Should we expect that the your planning for sort of a classic phase 3 setup with the overweight overweight diabetics, Etc are the room for some new phase 3 tries. I'm I'm thinking maybe sort of a glp1 naive or glp 1 failures where you could sort of, differentiate Petri even more versus what's on the mind to say,

Thank you for your question and these are super important um considerations which we are discussing with us right now. And we will we will have to wait a little bit to provide updates but I would

Kind of also say that since we are developing an alternative, it's probably.

You don't need to as long as you provide the first alternative with a more pleasant, uh, side effect profile.

Most patients, do not stay in the therapy on the G, the ones today. So I don't need to go out and convince the patients to stop taking something and then get on your new treatment. Most patients.

Adam Lange: This focus on shifting and so on from being on a GLP-1 to getting to another modality, I think is less of an issue here because we know from market data that most patients do not stay on GLP-1 for a long time.

David Kendall: Great, thanks.

Who have been exposed to it. The other 1 will at the time. We launch it not be on a TV 1 so this focus on shifting and so on from being on the other 1 to getting to a novel modality, I think it's less of an issue here because we know from Market data that patients, most patients do not stay until the 1 for a long time.

Adam Lange: Thank you. Thank you all for attending and for your questions today. We look very much forward to future announcements and updates and to connecting in the coming weeks and months.

Great, thanks. Thank you.

Thank you all for attending and for your questions today. We look very much forward to Future announcements and updates and to connecting in the coming weeks and months.

Rhoda Raiden: This concludes today's conference call. Thank you for participating. You may now disconnect.

This concludes today's conference call, thank you for participating. You may now disconnect

Q2 2025 Zealand Pharma AS Earnings Call

Demo

Zealand Pharma

Earnings

Q2 2025 Zealand Pharma AS Earnings Call

ZEAL

Thursday, August 14th, 2025 at 12:00 PM

Transcript

No Transcript Available

No transcript data is available for this event yet. Transcripts typically become available shortly after an earnings call ends.

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