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Zealand Pharma A/S
5/8/2025
Good day and thank you for standing by. Welcome to the Zealand Pharma Results for Q1 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 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1, 1 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.
Thank you, Operator, and thank you to everyone for joining us today to discuss Seal & Pharma's results for the first three months of 2025. You can find the related company announcement on our website at sealandpharma.com. As described on slide two, I caution listeners that during this call, we will be making forward-looking statements that are subject to risks and uncertainties. Turning to slide three and the agenda. With me today are the following members of Seed and Pharma's management team. Adam Steensmaer, President and Chief Executive Officer, Henrietta Wendiger, Chief Financial Officer, and David Kendall, Chief Medical Officer. All speakers will be available for the Q&A session along with Eric Cox, Chief Commercial Officer. Moving to slide four, I will turn the call over to Adam Stingsberg, President and CEO.
Thank you, Adam. And thanks to everyone for joining today. CELAN has never been in a stronger position than we are today, financially, organizationally, and in terms of our clinical development pipeline. Our vision is to become a key player in the future management of obesity. and we now have the strongest possible foundation to realize this vision. We have a differentiated mid- to late-stage obesity pipeline and recently entered a historic and transformative collaboration with ROSE on 4-petrillion-tide. The agreement with ROSE includes co-development and co-commercialization rights, a 50-50 profit sharing in the US and Europe and as a new product candidate to our pipeline in the form of Petrinatide CT388, we look very much forward to embarking on this partnership with Roche, aiming to establish the leading amylin franchise with Petrinatide as a future foundational therapy for weight management. Both of our late-stage rare disease programs have a clear path forward. We remain committed to bringing these programs to patients as quickly as possible while actively exploring partnership opportunities. During the last two years, we have significantly strengthened the organization to prepare ourselves for this unique next phase of accelerated growth. And importantly, we have secured enough capital to fund our journey towards profitability. In the last period, we have seen geopolitical and market uncertainty. In general, I believe Sealand is in a strong position to meet these challenges as we expand our operations and invest for accelerated growth. Our strong capital situation allows us to progress towards profitability with confidence and our execution power has been significantly improved both due to the strengthening of our organization and due to the Rose Partnership for Protenatide, where they are responsible for setting up commercial manufacturing and supply. We believe that amylin analogs holds the potential to become the future leading category for weight management. The increasing body of clinical evidence supporting the safety, tolerability, and efficacy of amylin analogs have derisked the amylin, the Protenatide program as well. In fact, there has been a short-acting amylin analog on the market approved for diabetes for more than 20 years. And in December last year, we saw phase three data with another long-acting amylin analog that appeared to have a safe and well-tolerated profile, further de-risking the class. Thus, in Petrinatide, we are based on the clinical data reported to date, and due to the molecular-specific attributes, confident in our best-in-class potential, and thus a unique opportunity to build the leading amine-based franchise for weight management. Turning to slide five, we have a strong focus on building the foundation for the next phase of accelerated growth for Sealand. Fueled by the partnership with ROSE, we can now increase our efforts on several fronts, including significant new investments in the research pipeline targeting obesity and inflammation. Due to the type of partnership agreement that we have entered with Rose for the training side, retaining equal strategic rights and 50-50 profit sharing in the US and Europe, Ceylon has the potential to become a very different company in just a few years. And we need to have a pipeline that reflects such a company. In recent months, we have strengthened the organization across all layers. Stephen Smith, a recognized leader in obesity and metabolism clinical research, has joined us as medical advisor in obesity. Stephen will be central in advancing our obesity research and clinical development programs in our pursuit of addressing one of the biggest healthcare challenges of our time. In April, we were excited to welcome Udpal Singh as our chief scientific officer and new member of the executive team at Sealand Pharma. Utpal brings nearly 25 years of industry experience spanning the full drug discovery and development lifecycle, most recently as Senior Vice President of Small Molecule Discovery at Lilly, where he spent more than 18 years. Utpal will lead the discovery and clinical translation of peptide medicines, leveraging technologies including data science and AI to enhance our discovery process. Hence, Woodpile will drive the next wave of differentiated innovative therapies at Seed&Pharma and will be instrumental in building the company into an enduring and generational biotech. This leads me to slide six. We are focused on developing new and better treatment options for people with overweight and obesity to tackle one of the greatest healthcare challenges of our time. We are still in the very early days of the evolution of this market. In the U.S., only about 2% of eligible patients with overweight and obesity are on pharmacotherapy today. Despite the availability of once-weekly tier-1-based therapies, real-world treatment persistence remains a challenge, and the number of patients benefiting long-term from these treatments has not yet seen a substantial improvement. There is thus a significant unmet medical need for therapies that can deliver effective weight loss but with an improved tolerability and acceptability compared to current therapies on the market including a lower frequency and milder severity of gastrointestinal adverse events so that patients may have a more positive experience and can better achieve and importantly maintain a healthy weight loss. In a weight loss Maintenance setting. We believe that gastrointestinal adverse events like diarrhea, constipation, and this feeling of having lost your appetite experienced by many patients on a GLP-1 based therapy are just as important as the more commonly discussed nausea and vomiting. While all GLP-1s and once monthly injectable GLP-1s may help expand the overall GLP-1 class, we view them more as complementary approaches rather than distinct alternatives. With the potential for an improved gastrointestinal tolerability profile and differentiated mechanism of action that makes people feel full faster rather than suppressing their appetite, we believe that amyloid analogs can be the preferred choice for the vast majority of people with overweight and obesity, both during weight loss and importantly in the weight maintenance setting. And with that, let's move to slide seven as I turn over the call to our Chief Medical Officer, David Kendall, to discuss our R&D pipeline. David?
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