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 has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog aimed at treating short bowel syndrome (SBS) in adults [1][2]. Company Overview - Zealand Pharma A/S is a biotechnology company focused on developing innovative peptide-based medicines, with more than 10 drug candidates in clinical development, including two that have reached the market [12][13]. Product Development - Glepaglutide is designed as a liquid product for subcutaneous administration, intended to reduce or eliminate the need for parenteral support in SBS patients [4]. - The MAA submission is based on results from the pivotal Phase 3 trial (EASE-1) and interim results from ongoing long-term extension trials (EASE-2 and EASE-3) [2][3]. Clinical Trial Results - EASE-1 trial involved 106 SBS patients, showing that glepaglutide administered twice weekly significantly reduced weekly parenteral support volume by 5.13 liters compared to 2.85 liters in the placebo group [6]. - In EASE-1, 9 patients treated with glepaglutide achieved enteral autonomy, while no patients in the placebo group were able to discontinue parenteral support [6]. - EASE-2 continues to evaluate the efficacy of glepaglutide, with interim analyses indicating maintained or improved clinical responses [8]. Future Plans - Zealand Pharma plans to initiate the EASE-5 Phase 3 trial in the second half of 2025 to gather further confirmatory safety and efficacy data for regulatory submission in the U.S. [3][11].

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].