Core Insights - Amylin, a previously overlooked target, is emerging as a significant player in the multi-billion dollar weight loss market, particularly with the recent data from Novo Nordisk's cagrilintide and its combination with semaglutide showing promising weight loss results [1][2][3] Group 1: Clinical Developments - Novo Nordisk's cagrilintide achieved an average weight loss of 11.8% after 68 weeks of treatment in the REDEFINE 1 study [1] - The combination formulation CagriSema, which includes cagrilintide and semaglutide, demonstrated an average weight loss of 20.4%, significantly outperforming monotherapy [1][9] - Novo Nordisk has registered a Phase 2 clinical trial for NNC0662-0419, a GLP-1/GIP/Amylin triple agonist [1] Group 2: Industry Movements - Pfizer announced a $4.9 billion cash acquisition of Metsera to strengthen its weight loss pipeline, leading to a significant surge in Metsera's stock price [1] - Major pharmaceutical companies like Roche, AstraZeneca, Eli Lilly, and AbbVie are increasingly investing in Amylin through collaborations and acquisitions [2][11] Group 3: Mechanism and Competitive Advantage - Amylin is not a new target; it was discovered in 1987 but faced challenges in earlier formulations due to short half-lives and side effects [3][4] - New generation Amylin analogs have significantly improved half-lives, allowing for less frequent dosing, which enhances patient compliance [5][10] - Amylin's mechanism offers complementary effects to GLP-1, potentially leading to better patient outcomes through combined therapies [8][9] Group 4: Future Directions - The industry consensus is shifting towards collaborative strategies rather than isolated competition, with companies exploring combinations of Amylin and GLP-1 for enhanced efficacy [12][16] - Innovations in drug delivery systems, such as long-acting formulations and oral delivery methods, are being prioritized to improve patient adherence and treatment outcomes [15][16]

PresentationI think we'll get going if that works for everyone. I'm Charlie Haywood from the BofA EU Pharma team. My pleasure to be hosting David Kendall today, CMO of Zealand. Obviously, I'd say you haven't got any official introduction, but I guess as a quick 2-minute overview of where we're at, where Zealand is at, how has the year been, et cetera, been an exciting year for you. So that would be a great way to start.David KendallExecutive VP, Chief Medical Officer & Head of R&D Very good. Thanks, Charlie ...

Summary of Zealand Pharma Conference Call Company Overview - **Company**: Zealand Pharma (OTCPK:ZLDP.Y) - **Date**: September 25, 2025 - **Key Speaker**: David M. Kendall, Chief Medical Officer Core Industry Insights Partnership and Product Development - Zealand Pharma has established a partnership with Roche, focusing on the petrelintide asset, which is progressing towards phase 3 trials [3][5] - Ongoing phase 2 studies are expected to yield results in the first half of next year [3] - The company aims to position itself as a key player in the obesity and metabolism space, beyond its existing Zegalogue franchise [4] Market Dynamics - The obesity market is evolving rapidly, with projections indicating that 40% to 50% of the global population will be overweight or obese in the coming decade [8] - There is a shift towards patient-driven demand for weight management therapies, contrasting with traditional provider-driven approaches [9][10] - Zealand Pharma believes that amylin-based therapies, particularly petrelintide, could become foundational in managing obesity [4][5] Product-Specific Insights Petrelintide Development - Petrelintide is expected to achieve weight loss comparable to GLP-1 therapies, with estimates of mid-teens to 20% weight loss [12][13] - The phase 2b trial aims to leverage tolerability and lower starting doses with monthly dose escalations [19] - The trial design will focus on a representative population, including a balanced gender ratio and higher BMI [20] Competitive Landscape - Petrelintide is positioned as a better-in-class option compared to other amylin agonists, with a 100% response rate in early studies [26] - The adverse event profile of petrelintide is expected to be favorable compared to competitors like kagrelintide and LRL-NTIDE [28][30] - Zealand Pharma is confident in the safety and efficacy of petrelintide, with no significant neuropsychiatric side effects reported [36][37] Regulatory and Market Considerations - The regulatory landscape is evolving, with expectations for higher efficacy and tolerability standards for new therapies [44][45] - Zealand Pharma is monitoring the potential for oral formulations but believes that injectables will remain the dominant delivery method in the obesity market [48][50] Future Outlook - Zealand Pharma is optimistic about the potential of petrelintide and its partnership with Roche to capture a significant share of the obesity market [11][35] - The company is preparing for phase 3 trials and is focused on optimizing trial designs to meet regulatory requirements and market needs [12][14] Conclusion - Zealand Pharma is strategically positioned in the growing obesity market with innovative therapies like petrelintide, backed by a strong partnership with Roche and a focus on patient-driven demand for weight management solutions [5][11]

Core Insights - Pfizer (PFE) has announced a definitive agreement to acquire Metsera (MTSR), a developer of obesity drugs, to re-enter the obesity market after discontinuing its own weight-loss pill, danuglipron [1][5]. Company Summary - Pfizer will acquire Metsera's shares for $47.50 per share, totaling an enterprise value of $4.9 billion, with an additional contingent value right (CVR) of up to $22.50 per share based on clinical and regulatory milestones [2][10]. - The acquisition includes Metsera's four clinical-stage programs, notably the GLP-1 receptor agonist MET-097i, which is currently in phase II studies [3][10]. - The boards of both companies have unanimously approved the transaction, expected to close in Q4 2025, pending shareholder approvals [4]. Industry Summary - The obesity market is projected to grow to $100 billion by 2030, with Eli Lilly (LLY) and Novo Nordisk (NVO) currently leading the market with their GLP-1 injections [6]. - Other companies, including Amgen and Viking Therapeutics, are also developing advanced GLP-1-based candidates in late-stage studies [7]. - Metsera's products are in early development stages, with potential market entry around 2028-2029, indicating that Pfizer may lag behind competitors in this highly competitive space [8]. - Other large pharmaceutical companies, such as AbbVie, Roche, and Merck, are also entering the obesity market through licensing deals with smaller biotech firms [9][11][12].

Core Insights - Roche Holdings AG aims to become a leading player in the growing weight-loss drug market, advancing its obesity pipeline into late-stage development to compete with Eli Lilly and Novo Nordisk [1] - The company has initiated a Phase 3 trial for its experimental obesity treatment CT-388, which was acquired through the 2023 purchase of Carmot Therapeutics [1][2] - Roche plans to have six obesity and related-condition therapies on the market by 2030, with three expected to generate over $1 billion in annual sales [3] Obesity Drug Pipeline - CT-388 has shown significant weight loss results in a Phase 1b trial, demonstrating its potential effectiveness as a once-weekly subcutaneous injection over 24 weeks [2] - Teresa Graham, head of Roche's pharmaceutical division, emphasized the company's commitment to becoming a top three player in the obesity drug market [3] Strategic Acquisitions - Roche has made significant acquisitions to bolster its obesity portfolio, including Zealand Pharma's experimental therapy petrelintide for up to $5.3 billion and U.S. biotech 89bio for up to $3.5 billion, targeting liver disease treatments [4] Other Developments - Roche released positive results from the Phase 3 evERA study for giredestrant in combination with everolimus for specific breast cancer types, meeting both co-primary endpoints and showing improvement in progression-free survival [5][6] - The giredestrant combination was well tolerated, with no new safety signals observed, marking a significant achievement in head-to-head trials [7]

Core Viewpoint - Roche is set to acquire 89bio for $3.5 billion to enhance its portfolio in cardiovascular, renal, and metabolic diseases [1][8] Acquisition Details - Roche will pay $14.50 per share in cash, totaling an equity value of approximately $2.4 billion [3] - 89bio shareholders will also receive a contingent value right (CVR) worth up to $6.00 per share, dependent on achieving specific commercial milestones [4] - If all CVR conditions are met, 89bio's shareholders could receive an additional cash consideration of up to approximately $1.0 billion [5] Pipeline Enhancement - The acquisition will add 89bio's pegozafermin, a phase III candidate for metabolic dysfunction-associated steatohepatitis (MASH), to Roche's pipeline [2][6] - Pegozafermin has a unique mechanism of action, potentially offering enhanced efficacy and tolerability, and may create synergies with Roche's existing CVRM portfolio [6] Market Context - MASH is a prevalent comorbidity of obesity, presenting a significant revenue opportunity for Roche as the obesity treatment market is lucrative [7] - Roche's shares have increased by 20.4% year-to-date, outperforming the industry growth of 2.5% [7] Strategic Moves - Roche has been actively seeking to enter the obesity treatment space, having previously collaborated with Zealand Pharma to co-develop petrelintide [9][10] - The recent acquisition trend in the pharma/biotech sector indicates a focus on portfolio expansion and pipeline innovation, with other companies like Novartis also engaging in significant acquisitions [10][11]

Group 1 - The company is pursuing its ambition to become a key player in the growing obesity market [1] - A significant collaboration agreement has been established with Roche regarding the main asset, petrelintide [1] - The focus with Roche is to accelerate the development program for petrelintide [1] Group 2 - Upcoming key data readouts are expected for petrelintide in Phase II and for survodutide, which is licensed to Boehringer in Phase III [1] - The company expresses excitement about the upcoming period and the rapid news flow [1]

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]

Investment Rating - The industry investment rating is "Positive" (maintained) [2] Core Insights - The report highlights the significant potential of the amylin market, with major pharmaceutical companies making substantial investments in amylin molecules, indicating a strong growth trajectory [6][9] - Amylin products are showing promising early clinical data in terms of safety and weight loss efficacy, with specific examples demonstrating competitive advantages over existing treatments [7][22] - A dense pipeline of catalysts is expected in the next 6-12 months, with multiple companies set to release critical clinical trial data that could validate the product profiles of amylin candidates [8][29] Summary by Sections Recent Major BD Transactions - AbbVie and Roche have made significant investments in amylin molecules, with AbbVie paying an upfront fee of $350 million and potential milestone payments of up to $1.875 billion for Gubra's amylin molecule [6][17] - Roche has partnered with Zealand to develop petrelintide, with an upfront payment of $1.65 billion and milestone payments reaching $3.6 billion [6][17] Amylin Product Profile - Early data for amylin monotherapy shows excellent safety and weight loss results, with examples like Eli Lilly's Eloralintide demonstrating a maximum weight loss of 11.3% at 12 weeks [7][22] - The report notes that the majority of weight loss from Eloralintide is fat, with preclinical data showing up to 91% of weight loss being fat [23][28] Future Catalysts - A significant number of amylin pipeline data readouts are expected in the next 6-12 months, with major companies like Roche, Eli Lilly, and AstraZeneca anticipated to release phase 2 trial data [8][29] - Companies such as Viking, Structure, and others are also highlighted for their clinical trial progress in the amylin space [8][29] Investment Recommendations - The report recommends focusing on companies like Borui Pharmaceutical and Zhongsheng Pharmaceutical, which are expected to accelerate their presence in the amylin market [9][31] - Beneficiary companies include Viking, Structure, Metsera, and Jiuyuan Gene, which are positioned to gain from advancements in the amylin sector [9][31]

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].