Q1 2025 Zealand Pharma A/S Earnings Call
Speaker Change: Good day, and thank you for standing by. Welcome to the Zealand Pharma Results for Q1 2025 Conference Corps.
At this time all participants are in a listen only mode. [inaudible]
Speaker Change: After this speaker's presentation, there will be a question and answer session.
Speaker Change: To ask a question draw in 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.
Speaker Change: Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Adam Langer, Vice President Investor Relations. Please go ahead.
Adam Langer: Thank you, operator, and thank you to everyone joining us today to discuss Zealand Pharma's results for the first three months of 2025.
Speaker Change: You can find the related company announcement on our website at www.sealanshama.com
Speaker Change: As described on slide two, I cautioned listeners that during this call, we will be making forward-looking statements that are subject to risks and uncertainties.
Turning to slide three and the agenda.
Speaker Change: With me today are the following members of Seaton Pharma's management team. [inaudible]
Speaker Change: Adam Steensberg, President and Chief Executive Officer Henriette Wennicke, Chief Financial Officer and David Kendall, Chief Medical Officer
Speaker Change: All speakers will be available for the Q&A session along with Eric Cox, Chief Commercial Officer.
Speaker Change: Moving to slide four, I will turn the call over to Adam Steensberg, President and CEO .
Thank you, Alan, and thanks to everyone for joining today.
Speaker Change: Zealand has never been in a stronger position than we are today financially, organizationally, and in terms of our clinical development pipeline.
Speaker Change: Our vision is to become a key player in the future management of obesity.
Speaker Change: and we now have the strongest possible foundation to realize this vision.
Speaker Change: We have a differentiated, mid-to-late, base obesity pipeline and recently ended a historic and transformative collaboration with Rose Unforbid training site.
Speaker Change: The agreement with Rose includes co-development and co-commercialization rights, a 50-50 profit sharing in the US and Europe , and adds a new product candidate to our pipeline in the form of the tree inside CT-388.
Speaker Change: We look very much forward to embarking on this partnership with Rose.
Speaker Change: Aiming to establish the leading Emmeline franchise with Patrine type as a future foundational therapy for weight management.
Speaker Change: Both of our late-stage radiacies programs have a clear path forward. We remain committed to bringing these programs to patients as quickly as possible, while actively exploring partnership opportunities.
Speaker Change: During the last two years, we have significantly strengthened the organization to prepare also for this unique next phase of accelerated growth.
Speaker Change: And importantly, we have secured enough capital to fund our journey towards profitability.
In the last period, [inaudible]
Speaker Change: We have seen geopolitical and market uncertainty. In general, I believe Zealand is in a strong position to meet these challenges as we expand our operations and invest for accelerated growth.
Speaker Change: Our strong capital situation allows us to progress towards profitability with confidence.
Speaker Change: and our execution power has been significantly improved both due to the strengthening of our organization and due to the rose partnership for Patreonsite where they are responsible for setting up commercial manufacturing and supply.
Speaker Change: We believe that Emily Nanalot holds the potential to become the future leading connect category for weight management.
Speaker Change: The increasing body of clinical evidence supporting the safety, tolerability and efficacy of amelene analogs have de-raced the amelene, the protein-side program as well. In fact, there has been a short-acting amelene analog on the market approved for diabetes for more than
Speaker Change: And in December last year we saw face-feed data with another non-acting amyline analog that appears to have a safe and well tolerated profile further directing the class.
Speaker Change: Thus, in Petrienside, we are based on the clinical data reported to date and due to the molecular-specific attributes confident in a best-in-class potential, and thus a unique opportunity to build the leading eminent-based friendships for weight management.
Turning to slide five [inaudible]
Speaker Change: We have a strong focus on building the foundation for the next phase of Accelerated Growth for Zealand.
Speaker Change: Fueled by the partnership with Rose, we can now increase our Air Force on several fronts, including significant new investments in the research pipeline targeting obesity and information.
Speaker Change: Due to the type of partnership agreement that we have entered with Rose for the training side, retraining equals strategic rights and 50-50 profit sharing in the US and Europe , Zealand has the potential to become a very different company in just a few years.
Speaker Change: and we need to have a pipeline that reflects such a company.
Speaker Change: In recent months, we have strengthened the organization across all layers. Steven Smith, a recognized leader in obesity and metabolism clinical research, has joined us as medical advisor in obesity.
Speaker Change: Steven will be central in advancing our obesity research and clinical development programs in our pursuit of addressing one of the biggest healthcare challenges of our time.
Speaker Change: In April , we were excited to welcome good person as our chief scientific officer and new member of the executive team at Zealand Pharma.
Speaker Change: Woodpell brings nearly 25 years of industry experience spanning the full drug discovery and development life cycle, most recently a senior vice president of small molecule discovery at Leely.
Where he spent more than 18 years. [inaudible]
Speaker Change: Woodpecker will lead the discovery and clinical translation of peptide medicines leveraging technologies include data science and AI to enhance our discovery process.
Speaker Change: Hence, we can drive the next wave of differentiated innovative therapies as seen in Pharma and will be instrumental in building the company into an enduring and generational biopsy.
This leads me to slide six.
Speaker Change: We are focused on developing new and better treatment options for people with overweight and obesity to tackle one of the greatest healthcare challenges of our time.
Speaker Change: We are still in the very early days of the evolution of this market. In the US only about 2% of eligible patients with or with an obesity are on pharmacotherapy today.
Speaker Change: Despite their availability of one-weekly to the one-based therapies, real-world treatment to systems remains a challenge, and the number of patients benefiting don't-term from these treatments has not yet seen a substantial improvement.
Speaker Change: There's thus a significant unmanned medical need for therapies that can deliver effective weight loss.
Speaker Change: But with an improved tolerability and acceptability compared to current therapies on the market.
Speaker Change: including a lower frequency and milder severity of gastrointestinal adverse events so that patients may have a more positive experience and can better achieve and importantly maintain a healthy
Speaker Change: In a way, those maintenance settings, we believe that gastrointestinal adverse events like diarrhea, constipation, and this feeling of having lost your appetite experienced by many patients on a dearly one face therapy are just as important as the more commonly discussed nausea and vomiting.
Speaker Change: While all TRT1s and once monthly injectable TRT1s may help expand the overall TRT1 class, we view them more as counter-mentary approaches rather than distinct alternatives.
Speaker Change: with the potential for an improved gastrointestinal probability profile and differentiated mechanism of action that makes people feel full faster.
Speaker Change: Rather than suppressing their appetite, we believe that Emily Lennonlox can be the preferred choice for the vast majority of people with all weight and obesity
Speaker Change: Both doing weight loss and importantly in the weight loss maintenance setting.
Speaker Change: 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?
Thank you, Adam [inaudible]
Speaker Change: Today, I would like to focus my remarks on the continued advancement of our obesity programs in particular Petrol and Dide, following the announcement of our exciting partnership with Roche, and I will also provide a brief update on our other ongoing development and regulatory activities.
Let's move to slide 8.
Speaker Change: We now have the opportunity, together with our partner Roach, to establish the leading Ameland-based franchise for weight management and rapidly expand into obesity-related comorbidities.
Speaker Change: We believe such a product profile has the potential to address the unmet medical needs for the majority of people living with overweight and obesity, thus positioning Petrelentide as a foundational therapy.
Speaker Change: We also maintain that Petrelentide has the potential as a best-in-class therapy. This asset is both physically and chemically stable with no fibrillation at physiologic pH, and Petrelentide was developed so that can be co-administered and co-formulated with other peptide-based therapies.
Speaker Change: The broad collaboration scope with Roch allows us to explore and unlock the full potential of petroleum dide and reaches many patients with overweight and obesity as possible.
Speaker Change: Together we will leverage the advantageous attributes of Patrellantide and explore the candidate in combination with other agents.
Speaker Change: One novel concept that we find interesting with the Petrolentide CT-388 Fixed-Dose combination product is to maximize the dose of the generally better tolerated non-incredent agent Petrolentide
Speaker Change: having the optimized dose of the Inkerton-based GLP1-GIP therapy for people who both need and desire more weight loss and or improve glycemic control without materially compromising tolerability.
Speaker Change: Together with Roche, we look forward to initiating phase two trials with the Patralentide CT-388 Stokes combination product in early 2026 and to explore other potential Patralentide based combination products as we move forward.
Speaker Change: In December , 2024, we initiated a large and comprehensive phase 2 trial with Petrolatide and people with overweight or obesity.
Speaker Change: Zouprim I, a dose-finding trial assessing the safety and efficacy of five doses of patrellandide versus placebo, over 42 weeks of treatment.
Speaker Change: We were also excited to announce the completion of enrollment for this trial in March 2025 just three months after trial initiation, and we look very much forward to reporting top line results from Zupreme 1 in the first half of 2026.
Speaker Change: In April 2025, we also announced the initiation of Zupreme 2, phase 2 trial of Patreontide in persons with overweight, or obesity and co-existing type 2 diabetes.
Speaker Change: In this population, data suggests that amulet agonism may potentially deliver weight loss comparable with that observed in the non-divities population.
Speaker Change: Another potentially important differentiation opportunity with Amel and Agonist, as compared to GLP-1-based therapies, where attenuation of weight loss has been consistently observed when comparing those with diabetes to those without diabetes.
Speaker Change: The expect to complete the Supreme 2 trial in the first half of 2026.
Speaker Change: Turning to Slide 10, for some remarks on Servadoo Tide and Dappy Clute Tide.
Thank you very much.
Thank you. Bye.
Speaker Change: Servaduteida, dual Gleukhagan GLP1 receptor agonist, is in late-stage development for both obesity and metabolic dysfunction-associated stiato hepatitis or mesh.
Speaker Change: In the first quarter of 2025, Baron Geringelheim completed enrollment in the Phase 3 synchronized cardiovascular outcomes trial, marking full enrollment in all trials in the Phase 3 Obesity Programme.
Speaker Change: We look forward to top-line data from the first phase three trial and people with overweight or obesity anticipated in the first half of 2026.
Speaker Change: Beringer, Engelheim, expects to launch Servadutide in 2027 or 2028, and if successful, Servadutide could be the third Inquitant-based therapy to market, and it would be the first approved dual Blue Kagan GOP1 receptor agonist in this exciting era of novel weight loss therapies.
Speaker Change: We are very excited about the ongoing phase three program in people with MASH, which represents the largest ever phase three MASH program with an Inquatim based therapy and the only program to also include people with compensated cirrhosis.
Speaker Change: Bash is one of the most prevalent and serious obesity related comorbidities with significant
Speaker Change: It is estimated that one third of people with overweight and obesity have mass [inaudible]
Speaker Change: With best-in-class smash data presented last year from a 48-week phase to trial, we believe servodutide has the potential to become the preferred therapy in a very large and growing market, benefiting patients who urgently need more and better treatment options.
Speaker Change: Dappie Glutide is designed as a potent GLP1 receptor agonist targeting significant weight reduction and offers the potential to also leverage GLP2 pharmacology to improve gut barrier function and address the low-grade inflammation associated with metabolic disease.
Speaker Change: We look forward to presenting the results from part one of the phase one B dose titration trial with Dappie Glutay at the American Diabetes Association's 85th Scientific Sessions in June 2025.
Speaker Change: In the second quarter of 2025, we also look forward to reporting top-line results from part two of the phase one B trial investigating higher doses of rapid glutide over 28 weeks of treatment with subsequent initiation of a phase two trial.
Speaker Change: Moving to slide 11 and a brief update on our rare disease programs.
Speaker Change: For Dawsey Gluka-Guyne, Inc., Hyperincentism, Resubmission of Part 1 of our original new drug application and the subsequent submission of Part 2 are contingent on an inspection classification upgrade of our third party manufacturer's facility.
Speaker Change: While we await the potential classification upgrade, we are implementing a supply contingency plan in parallel, including qualification of an alternative supplier to ensure that we can bring this product to patients in need as quickly as possible.
Speaker Change: Furgle Pagletide for the treatment of short bowel syndrome with intestinal failure. We successfully completed the type A meeting with the US FDA in March 2025.
Speaker Change: We have now insured alignment on the trial design phase three eaves five trial so that it can support regulatory submission in the US.
Speaker Change: and we remain on track to initiate ES5 in the second half of 2025, and we expect to share more details on the trial design later this year.
Speaker Change: We also still anticipate submitting a marketing authorization application in the second half of 2025 to support the approval of Gopagazide in the EU.
Speaker Change: With that, I would now like to turn the call over to our Chief Financial Officer, Henrietta Wennicke, to review our financial results for the first quarter of 2025. Henrietta?
Henriette Wennicke: Thanks David and hello everyone. Let's turn to Slide 12 and the Income Statement.
Henriette Wennicke: Revenue in the first three months of 2025 was 8 million DKK, mainly driven by the license and development agreements of Shake a Lock with no one orders.
Henriette Wennicke: Review from the initial upfront payment of 1.4 billion US dollars related to the collaboration and lighting agreement with Rosh will be accounted for upon closing of the agreement as we expect in the second quarter of 2025.
Henriette Wennicke: Research and development expenses of 290 million DKK are mainly driven by the development opportunities, including the last phase two Supreme One trial and preparation for the phase two.
Supreme Tutorial, Mitch Fassini, April 2025.
Henriette Wennicke: Sales and marketing expenses of 37 million DKK are made known by pre-commercial activities
Henriette Wennicke: General and admin expenses of 65 million DKK reflect the continuous strengthen of the organization capabilities as you prepare the organization for the Roch partnership as well as investment in IT infrastructure and our patent portfolio.
Henriette Wennicke: Net financial items of 70 million DKK are being driven by interest income from the excess liquidity invested in marginal securities.
Let's move to class 13 and the cast position.
Henriette Wennicke: S.F. Mark, 31, 2020, 25, Keshe, Keshe Agreement and Markable Securities, Total 8.5 billion DKK.
Henriette Wennicke: As mentioned, we expect to receive the $1.4 billion USD of front payment from Arche in the second quarter of 2025, equal to approximately $9.2 billion DKK.
Henriette Wennicke: Upon closing of the transaction, this will bring our cash position to roughly 18 billion DKK.
Henriette Wennicke: I can confidently say that we are in a really solid financial position.
Henriette Wennicke: On top of this, we will receive until $215 million in adverse payments over two years.
Henriette Wennicke: and potential development milestones are up to $1.2 billion. With the vast majority of these development milestones, being three years in a phase three trials, is the time monotherapy.
Henriette Wennicke: Another only confident that we can fully meet all our financial obligations on the Roch partnership
Henriette Wennicke: but also that our solid financial position provides ample flexibility to win with the on-perchum side.
Henriette Wennicke: including our early stage research pipeline, targeting obesity and information, and to further strengthen our organization capabilities in preparation for the growth journey ahead.
Henriette Wennicke: based on our pure technical and organizational plans. We project that we have the financial strength to take Zealand Pharma all the way to profitability with no need to raise additional capital.
This is truly a pivoted milestone for the company.
Turning to slide 14 and the financial guidance. [inaudible]
Henriette Wennicke: I will keep this short, and there are no changes to the outlook for the year compared to what the outline is February 2025.
Henriette Wennicke: We confirm the financial guidance on net operating expenses, which we are expected to be between two and two and a half billion DKK, excluding transaction-related costs associated with the
Henriette Wennicke: We expect these transaction-related costs to be approximated 200 million DKK in 2025.
Adam: And with that, I will move to site 15 and turn the call back to Adam for concluding remarks.
Thank you, Henriette.
Speaker Change: The first quarter of 25 was truly historic for Zealand Pharma, but I'm even more excited about what's to come.
Speaker Change: Saw the key catalyst over the next 12 months highlighted on this slide.
Speaker Change: First and foremost, we look forward to initiating our collaboration with Rose, one-step agreement is closed, which is expected here in the second quarter.
Speaker Change: and my wife , my husband, my mother, my son, my daughter, my husband,
Speaker Change: Regarding clinical data, we'll report additional results from the Phase 1B trial with epic guttides later this quarter. And in the first half of 26, I'm particularly excited about the Phase 2 top line results with Patreontide and top line results for the Phase 3 obesity trials with servodotide.
Moving to slide 16
Speaker Change: As a final note, I encourage all of you to save the date for Zealand Pharma's capital of Marges Day on December 11th, 25 in London.
Speaker Change: The event will feature speakers of our management team as well as thought leaders in obesity.
Speaker Change: We will speak in more details about this day later in the year and hope to see many of you there, either in person or online Thank you all, I will now turn over the call to the operator for questions
Thank you. Bye.
Speaker Change: Thank you. As a reminder to ask a question you would 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. [inaudible]
Speaker Change: We will take our first question and your first question comes from the line of Michael Novod, from Nadia. Please go ahead your line is open.
Thank you very much, Michael Novod from Nadia [inaudible]
Two questions, one to Petralintide and one to Clopaglutide.
Speaker Change: Did sort of the deal. I know you can't really talk together right now until the deal is closed, but the early discussions around different ratios for the Amelene versus the deal we want in order to try to improve tolerability, also with focus on how the initial data looked on for CT388.
Speaker Change: and then second before Prakhar's height, and I know it's already just out of the gates from one big collaboration, but maybe you can try to talk about how you...
Speaker Change: Tried to plan for out licensing of compactor tide. Will we see you already in the second half of this year trying to sort of close a deal on compactor tide? Or do we have to wait until potential launch in Europe or that you are progressing further towards the market in the US? Thanks.
Thank you, Michael, and the...
Speaker Change: I will hand over the first question to David and then the second question to Eric to talk about our efforts on Clevver Partnering, but David, will you take the first question please?
Speaker Change: was quite well. And of course, the very rapid titration scheme that was used in their early phase program has not given full clarity around how one can optimize tolerability of that increase in based therapy. But as we said in the prepared remarks, I think our goal once we see.
Speaker Change: Phase 2 data from both the Supreme One, as well as the first of the CT 388 programs. We will have a much better sense of where...
Speaker Change: Tolerability can be optimized, and formulation can be optimized to do as I described in my remarks.
Maximizing Patreontide and optimizing the 388 program.
Speaker Change: But to predict on a milligram basis at this point, part and phase two data being available would be premature, but
Speaker Change: Given both what we know about each asset, what we've learned from the Kegri Sema program, we think we can certainly maximize the weight-reducing capacity and further optimize that tolerability and acceptability profile, so more to follow Michael.
Speaker Change: And Eric, over to you. Thank you, David. And Michael, thanks for the question. I think with regard to the the Gleffe partner, you know, I think there's been a lot of interest prior to even prior to the APRA announcement. So I think we're very encouraged by the dialogue we're having. We'll still see that begin to progress. Thank you.
Speaker Change: I don't think we have a clear timeline on exactly when things will be moving forward, but there is quite a bit of interest here which I think is very encouraging as we move forward. So I think just hold tight and we'll better see where we move with this but we are very encouraged with the conversations we've had and they've been very productive at this point.
Okay, great, thank you very much [inaudible]
Thank you.
Speaker Change: Thank you. We will take our next question. Your next question comes from the line of Andy Shea from William Blair. Please go ahead. Your line is open.
Speaker Change: How do you envision designing studies to answer relevant clinical questions? Do you plan to do this in the space two setting or based on available PK data? It could be seamlessly incorporated in the space three program.
Speaker Change: Thanks for your question, and I will start by providing some more thoughts, and maybe David will add some flavors, but in general, I think if you look into...
Speaker Change: This space so far, most companies have actually focused on weight loss in order to achieve health which is why we are here, you need to make sure that patients' days and therapy are free.
Speaker Change: We think what we're seeing right now want to let the current medicines in the hands of patients and they're in a real world setting many patients struggle to stay on therapy and as we mentioned before our understanding is that it's actually not. [inaudible]
Speaker Change: It's mostly not due to the common, you can say, known side effects to the year the once-of-nose and vomiting. Many patients want to have a...
Adam Steensberg, Adam Steensberg, Anna Krassowska
with how much you push into weight loss.
Speaker Change: Let's say a very ambitious patient achieving 30% weight loss. That person may struggle to maintain such a dramatic weight loss because most people actually, once they get further into life, also would like to engage in social gatherings around food and you simply, many patients, simply feel they have to chance a life too much if they have these dramatic weight losses.
Speaker Change: So this is why we are super excited about the training style because we think it has more benign profile towards DI, so the ability and most importantly maybe because it works on average, it makes you feel faster, so it will basically not reduce the appetite but just make you feel faster.
Speaker Change: So the other thing that the industry have failed a little bit is to explore and I think that is what you have questioned alluded to how to dose these drugs in the maintenance phase.
Speaker Change: And this is something that we have of course anticipated, we will discuss further with Rose, how to address that because, as I said before, we think it's actually the most important phase to focus on.
Speaker Change: So it's clearly something that we expect to discuss further with Rose once we get the collaboration going. David, we want to add some more to that.
David Kendall: Yeah, just a couple of points and thank you, Andy, I agree in the line with Adam that I think, you know...
David Kendall: Soli, this arms race to a bigger number over a relatively short period of time.
Speaker Change: if that's a patient's desire or is of clinical interest. And I think in addition to what Adam has provided.
Speaker Change: Some of which we've learned from Prameland Tide in its history, first is that satiety signal, rather than this, and hedonic . . .
Speaker Change: Food Aversion, Signal, as Adam alluded to, that is not appealing to a lot of people, meaning avoiding food, whereas having the opportunity to maintain some degree of appetite but feeling full fast.
Speaker Change: is important. Remember, too, there are mechanisms that we only partially understand, and that's the leptin-sensitization if you can...
Ben Tain Sensitivity,
to the signal that comes from Adapose tissue, namely leptin. [inaudible]
Speaker Change: Will that allow you to continue to maintain a higher quality weight loss, not just a greater degree of weight loss? All of these will be parts of what I hope we can assess in these later clinical usefulness clinical applications studies. Thank you very much.
Thanks. Thanks, Andy. Thanks, Eddie.
Speaker Change: Thank you. We will take our next question. Your next question comes from the line of Prakhar Agrawal from Kanta Fitzgerald. Please go ahead. Your line is open.
Supreme One, and Obesity Vedant type of diabetes.
Speaker Change: and second question. Early data suggested weight loss benefit for Anne Lennon and type of diabetic <expletive> track, closer to obesity, but we didn't really see that materializing with Kagure Semoree, different to trial.
Speaker Change: So, wondering if the team had any thoughts here as it relates to the AMOIL plus GLB1 combination and would still expect AMOIL to have several weight loss in type 2 diabetes and obesity? Thank you.
Speaker Change: Thanks for your question and I'll just provide a few notes and then hand it over to David. We are kind of limited by the top dose that we're also exploring in the Supreme one, so it will be the top dose, the similar top dose we're exploring in Supreme two.
Speaker Change: Patients with Outtype 2 diabetes, and I think if you carefully look into the carcass-stimma data...
Speaker Change: and compared that to what was achieved with Simmer as a monotherapy, it was actually a very significant additional weight loss that no work served in the tattoo of these populations, probably closer doubling.
Speaker Change: The weight loss. So we think that is a very strong achievement especially because we don't think that you can say in that molecule you can say the amelene component has been utilized for its fullest extent where we think it's a low dose of amelene compared to what we progress with. [inaudible]
Speaker Change: So we have a lot of confidence still in this patient group. David, any further comments? Yeah, I'll just re-emphasize Adam what you said and that's Prakhar is that in the Kegri Soma program at least our perspective is that once again if you can...
Inkerton based therapy.
Speaker Change: Adam's point. I don't think we saw the full potential of the Amal and Aganist in that program. Obviously, the Supreme too is a standalone Amal and Aganist only.
Bear Wee
Speaker Change: and certainly, you know, both data historically from the Pramiland Tide studies and...
Speaker Change: More recently, the Phase 2 data with Cagrilla and Tide in the Type 2 diabetes Phase 2 study support this hypothesis.
Thank you [inaudible]
Thank you.
Van, Landshot, Kempon, please go ahead, your line is open. [inaudible]
Bye.
Speaker Change: Elotin, thanks a lot for taking my question. This is Karamun Tyroni, on the Alps of Suzanne Bavur 1000. So I was wondering, for the petroleum tide phase to be read out next year, what should we expect a top line release to include? And what would you consider a good result?
Speaker Change: And, yeah, I was also wondering whether these faiths to studies will include measurements of body compositions or any...
Speaker Change: Biomarkers that may feed into the potential of amylings for better quality of fat versus lean mass loss. Thank you.
Speaker Change: Thanks, I'll just start and then hand over the data so we do include measurements of body
Speaker Change: Good result. It's actually, I would say, probably too early to comment on that one. What we are aiming for is ultimately in phase three to have a product that demonstrates 15 to 20% weight loss.
David Kendall: And of course, the read out here only goes up to 48 weeks and we will continue for phase 3 studies for the wonker.
David Kendall: So, it's not only the numbers, also, of course, the slope of the curves at that time that defines what a good outcome is but as long as we are confident that we can achieve that profile we would be more than happy and then as we have also alluded to several times in this call So, let's move on to the next one.
David Kendall: Very important is to understand the telepathy profile which we think will be the key driver of differentiation compared to the tier two ones. David, any further?
will help us better understand. [inaudible]
Adam Langer: Non-clinical models. The second as Adam alluded to is not just the slope of the line, but are we seeing?
David Kendall: Clear separation of doses so that we can approach the regulatory authorities at end of phase two and say, you know, we have clear designs on specific doses for phase three execution.
I think it is important to remember that...
David Kendall: Given that tolerability is one of the things that we believe will...
allow us to differentiate Petrel and Tide.
but rather an understanding of can we...
David Kendall: Support the tolerability and acceptability profile and still see a trajectory that, as Adam alluded to, takes us to the 15 to 20 percent GLP-1 monotherapy like weight loss. So in general terms, those are the things we will be looking at at the end of phase two and with those top line results.
Thank you very much
Thank you
Thank you.
We will take our next question.
Speaker Change: Your next question comes from the line of Charlie Haywood from Bank of America. Please go ahead, your line is open.
Charlie Hayward: Where do you think of what's your vision for where you could get to for Patreon Mono Therapy stay time in the future?
especially in the context of maintenance therapy.
Speaker Change: and acknowledging that your git-bagginess hasn't moved for a while. Can you talk about your ambitions for future R&D in this sort of cardiometabolic space beyond the current portfolio? Any targets you see particularly interesting? Any unmet needs you expect to evolve? Thank you.
Thanks for your questions.
Speaker Change: Yeah, and we agree to the observations around the every day time for the TLC once, around seven months and I think it's really important when you discuss that seven months that you also appreciate that it's in a. Thank you very much.
Speaker Change: which is super negative because ultimately you only achieve health outcomes if you achieve weight loss and maintain that weight loss. So that's a shoot task ahead for the industry to make sure we develop weight loss agents that can help people not only lose weight but also help them maintain those weight losses.
Speaker Change: Because we have been so excited about seeing now the first tools, medical tools that can help people lose weight, I think somehow...
Speaker Change: In that conversation, we forgot about the patients, we forgot about, we are just humans who want to live a normal life, a little bit healthier life.
Speaker Change: But many patients want to have achieved the weight, or are not ready to make the commitments.
Speaker Change: of carrying the burden of diarrhea, constipation and that thing that you've lost to appetite and we think it will create a significant new opportunity with Patreon Tide if we can continue to do.
Speaker Change: They provide the results they've seen thus far. And of course, if you think about the market opportunity, if you can maintain patience and treatment for longer, that really is something that drives up volumes, instead of having to go out and capture new patients constantly.
Speaker Change: As we see right now, it's the case for the current launches. So we are, you can say, very positive on the opportunity to help patients stay on longer with a category like Emily and in particular, with training time.
Speaker Change: On the future pipeline, it's too early for me to comment on it, except that we will increase our investments big time.
and then you can say...
Speaker Change: The same for 11, that's probably where you will get the full vision for how we think about driving these the pipeline forward.
Speaker Change: But of course, it's also already today obvious from our pipeline chart that we have opportunities within.
Speaker Change: The chronic inflammation in monology with the KV-1.3 as an example, which is right now in Phase 1, which holds potential really to, you can say, become a pipeline within the program, so...
Speaker Change: You should expect to hear more in December , maybe also a little earlier, but have the full picture at our Camptomark's day in December . But thanks for the question.
Thank you.
Thank you. We will take our next question.
Speaker Change: Your next question comes from the line of Shan Hema from Jeffries. Please go ahead, your line is open.
Sian Hamer: Hi, thanks for taking my questions. There's two for me please. How will you define success in the phase to duck a gluteil study that you expect in a shoot during the second half of the year? And although I appreciate it's still quite far away, could you give us some initial thought on the potential topics for the capital markets then December ? Thank you very much.
Thanks
Shelby? And this is
Speaker Change: Honestly speaking, we don't think the world need that many more to everyone unless they are compared to what we already have in late clinical development out there unless they are truly differentiated on parameters that goes beyond just weight loss I think.
Speaker Change: On the capital of Margaret's Day, there's no question that a lot of the team will be around the obesity, how we see the market develop, how we see our product opportunities fitting into that space.
Speaker Change: Having here feeling leaders also talking, you can stay around some of the dynamics in the biology and then we would share more light around where we expect the early pipeline to develop in the coming years. Let's go.
Speaker Change: It will be hopefully a very content-rich day which also provides a very clear direction for our ambition in the coming years.
finding those. [inaudible]
Speaker Change: Comorbidities, or disease state targets where we believe Dappy can shine or outshine other Inkerton-based therapies. And you could say it's threading a needle, but more importantly, it is.
in our mind,
Speaker Change: finding those areas where either persistent or continued inflammation derived the disease process beyond weight management alone. And we believe, as I alluded to, that could be vascular inflammation, could be a paddock inflammation, could be neural inflammation. So success will start with the weight reducing effects and then finding. Thank you.
Those specific areas where we think Deppi Glutide can shine most.
Thanks a lot
Speaker Change: Thank you. Once again, if you wish to ask a question, please press star one, one on your telephone.
Speaker Change: We will take our next question. Your next question comes from the line of Oli Borough from Goldman Sachs. Please go ahead, your line is open.
Speaker Change: So we've seen some early data from ABV or Gubrist, Gubami, unless I'm upcoming data from Lillie's Alloral Entide ADA. So could you provide some perspectives on those two assets and why is petal entide differentiated versus those assets?
and then the second question on the Roch partnership.
Speaker Change: So, could you discuss potential cost share structures on R&D? Are there any caps to spend for Zealand?
Arthur, thank you very much.
for sure.
Speaker Change: Thanks a lot for your questions. If I start with the roast, it's a true, you can say 50-50 agreement where we will also share the cost from an R&D, not when it comes to investment in manufacturing or building up the supply chain, that is.
Speaker Change: Responsibility of Rose, but from an R&D perspective, we will share the cost and you can as Henrietta also alluded to doing her part of the presentation. We are confident that with the cast we have at hand and the expected near term milestones, we can cover our part and and.
Speaker Change: on top of that increase investment significantly. We are not yet providing clear guidance for what that part will be.
Speaker Change: If we decide to do that together with Rose, but we have ample opportunity to increase investments beyond the commitments we have into the program as it stands today in the plans, including pre-launch commercial activities.
and the competitive landscape, I think, of course.
Speaker Change: As we have also said for a long time, because Emmeline is such an attractive category, we should expect to see more competition in the future. We feel very confident around the best in class potential with Patreon type.
Speaker Change: which I think is also exemplified by the deal we announced recently and the consistency of the data that we have demonstrated across several clinical studies thus far.
Speaker Change: Also, you can say, when we do get timelines to market, we feel very comfortable in the position that we are sitting in now, in particular also with roles as a partner. Let's go on the show.
Speaker Change: We, as everyone knows, and as you also alluded to, Lily, they are expected to release data from their MN in only analog later this year, they have just closed the. [inaudible]
Speaker Change: Another Emily in program, which was based on Simon Kassitoni, and I think that's a category that has repeatedly been closed, at least an hour.
How we understand them, I get so...
Speaker Change: But now they are solely focused on an amelene-only molecule and we have not seen clinical data from that program whether they are going to pursue only combination therapies ultimately with placebo type or also monotherapy we don't know.
The collaboration between Gupra and AbbVie that was announced recently
Around that, Emily Anderson, awesome years behind us.
Speaker Change: And you can see so far these our understanding is it's a rather inconsistent data set that we have seen but of course we need to see more data and ultimately we would expect more competition in this.
But in that mix where you can see [inaudible]
No
Speaker Change: This is approaching phase three with Cagranitide and we look to be the next with what we believe a molecule that has best and best in class potentially feels very, very confident in our, you can say, journey ahead and
Speaker Change: And ultimately, we would welcome more competition in this space because we truly think this is the category that can solve the top of the group discussed so much in this call about how do we help patients not only achieve a weight loss but also weight maintenance. Thank you very much.
and we just filled.
Speaker Change: As a franchise and as a future foundational therapy for patients with obesity and associated diseases.
Awesome. Thank you.
Speaker Change: There are no further questions, I would like to hand back for closing remarks.
Speaker Change: With that, we would like to thank you all for attending and for your questions. We look forward to future announcements and updates and to connecting in the coming weeks and months. Thank you.
Speaker Change: Discountries today's conference call. Thank you for participating. You may now disconnect.
Anna Krassowska, Benjamin Jackson, Prakhar Agrawal, Thomas Bowers, David Kendall, Thomas Bowers, David Kendall