Core Insights - Zealand Pharma reported strong financial results for the first half of 2025, with revenue reaching DKK 9,096 million compared to DKK 49 million in the same period last year, indicating significant growth [4] - The collaboration with Roche on petrelintide is progressing well, with expectations for further updates at upcoming corporate events [6][7] - The company is well-positioned for future growth with key leadership appointments and a solid cash position of DKK 16,578 million as of June 30, 2025 [5][13] Financial Performance - Revenue for H1 2025 was DKK 9,096 million, a substantial increase from DKK 49 million in H1 2024 [4] - Operating expenses for H1 2025 were DKK 968 million, up from DKK 559 million in H1 2024, primarily due to increased R&D and transaction-related costs [4][5] - The operating result for H1 2025 was DKK 8,128 million, compared to a loss of DKK 524 million in H1 2024 [4] Collaboration and Development - Zealand Pharma's collaboration with Roche involves co-developing petrelintide, with a total deal consideration of USD 5.3 billion, including upfront cash payments of USD 1.65 billion [8] - The petrelintide program is advancing with Phase 2 trials progressing towards key milestones, and Roche is establishing a new manufacturing facility for obesity medicines [7] - Zealand Pharma submitted a Marketing Authorization Application for glepaglutide in June 2025, with potential regulatory approval expected in the first half of 2026 [9][22] Leadership and Strategic Direction - The company appointed Utpal Singh as Chief Scientific Officer and Steven Johnson as Chief Development Officer to enhance its innovation and development strategies [13] - Zealand Pharma is preparing for a Capital Markets Day in December 2025 to discuss future growth and strategies [17] Upcoming Milestones - Zealand Pharma expects to report topline results from the Phase 2 ZUPREME-1 trial and complete the Phase 2 ZUPREME-2 trial with petrelintide in the first half of 2026 [13] - The company anticipates initiating a Phase 2 trial for dapiglutide in the second half of 2025 [12]

Core Viewpoint - Zealand Pharma A/S announced positive preliminary results for its GLP-1/GLP-2 dual receptor agonist dapiglutide in a Phase I b multi-dose escalation trial, showing significant weight loss without lifestyle interventions [1][4]. Group 1: Trial Results - In the dapiglutide treatment group, participants experienced an average weight loss of 11.6% over 28 weeks, compared to only 0.2% in the placebo group [1][4]. - The trial included 30 participants, predominantly male (approximately 93%), with a median age of 44.5 years and a median starting body mass index (BMI) of 28.8 kg/m² [4][5]. - The trial demonstrated good tolerability at the highest dose of 26 mg, with no severe or serious treatment-related adverse events reported [4][5]. Group 2: Adverse Events - Most adverse reactions were mild gastrointestinal symptoms, such as nausea and vomiting, with two participants withdrawing due to adverse reactions, one related to gastrointestinal discomfort [4][5]. - Injection site reactions were minimal and all were mild, consistent with the profile of similar incretin drugs in other trials [4][5]. Group 3: Drug Mechanism and Future Directions - Dapiglutide is designed to address obesity-related comorbidities driven by chronic low-grade inflammation, combining GLP-1 mediated weight control and GLP-2's improvement of gut barrier function [7]. - Zealand Pharma is advancing a range of differentiated GLP-1 related therapies, including the insulin analog petrelintide, as potential foundational treatments in the weight loss field [4][7]. Group 4: Study Design - The Phase I b trial was a single-center, randomized, double-blind, placebo-controlled study, enrolling participants with a BMI between 27.0 and 39.9 kg/m² [5][6]. - The first part of the trial included 54 participants across three dosage groups, with results indicating an additional weight loss of 8.3% in the dapiglutide group compared to placebo over 13 weeks [5].

Core Insights - Zealand Pharma A/S announced positive topline results from a 28-week Phase 1b trial of dapiglutide, a dual GLP-1/GLP-2 receptor agonist, indicating significant weight loss and safety [2][3][4] Group 1: Trial Results - In the Phase 1b trial, 30 participants (approximately 93% male) experienced an estimated mean body weight decrease of 11.6% from baseline after 28 weeks of dapiglutide treatment, compared to a 0.2% decrease in the placebo group [3][8] - The trial showed that dapiglutide was safe and well-tolerated, with no severe treatment-emergent adverse events reported, and the majority of adverse events were mild gastrointestinal issues [4][8] Group 2: Trial Design - The Phase 1b trial was a single-center, randomized, double-blind, placebo-controlled study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of dapiglutide in participants with overweight or obesity [5][6] - Part 1 of the trial included 54 participants and demonstrated placebo-adjusted weight reductions of up to 8.3% after 13 weeks, while Part 2 involved 30 participants receiving 28 weekly doses of dapiglutide [6][7] Group 3: Drug Mechanism and Target Population - Dapiglutide is designed to leverage a dual mechanism involving GLP-1 and GLP-2, targeting obesity-related comorbid conditions driven by low-grade inflammation [9][10] - The drug aims to improve intestinal barrier function and address comorbidities associated with obesity, such as cardiovascular disease and liver disease [10]

Core Insights - Zealand Pharma has reported significant progress in its clinical pipeline and has established a transformative partnership with Roche for petrelintide, positioning the company for accelerated growth [1][3]. Financial Performance - For Q1 2025, Zealand Pharma reported revenue of DKK 8.1 million, a decrease from DKK 15.1 million in Q1 2024 [4]. - Operating expenses increased to DKK 393.1 million from DKK 266.3 million year-over-year [4]. - The operating result was a loss of DKK 385.5 million compared to a loss of DKK 255.8 million in the same quarter last year [4]. - The net financial items improved to DKK 70.3 million from DKK 25.8 million [4]. - The cash position as of March 31, 2025, was DKK 8,544.5 million, down from DKK 9,022.0 million at the end of 2024 [4]. Strategic Developments - Zealand Pharma entered a collaboration and license agreement with Roche to co-develop and co-commercialize petrelintide, sharing profits and losses on a 50/50 basis [4][5]. - The partnership aims to establish a leading amylin-based franchise for weight management and related indications [5]. - Zealand Pharma completed enrollment in the Phase 2 ZUPREME-1 trial for petrelintide three months after initiation [5][9]. Corporate Updates - Utpal Singh was appointed as Chief Scientific Officer to lead the next wave of innovative medicines [5][10]. - Steven R. Smith was appointed as Senior Global Medical Advisor in Obesity to support obesity research and clinical development programs [8]. Upcoming Milestones - Zealand Pharma expects to submit a Marketing Authorization Application for glepaglutide in the second half of 2025 and initiate a Phase 3 clinical trial [12]. - The company anticipates reporting topline results from the Phase 2 ZUPREME-1 trial in the first half of 2026 [14]. - Zealand Pharma plans to host a Capital Markets Day in London on December 11, 2025 [17]. Financial Guidance - The financial guidance for 2025 remains unchanged, with net operating expenses expected to be between DKK 2,000 million and DKK 2,500 million [18][19].