Company announcement – No. 1 / 2026 Zealand Pharma Announces Financial Results for the Full Year 2025 2025 marked a quantum leap for Zealand Pharma, with a transformative partnership for petrelintide, strong clinical progress, and organizational readiness, setting the stage for catalyst-rich and defining 2026 Entered a historic and transformative collaboration and license agreement with Roche to unlock the full potential of petrelintide as a future foundational therapy for weight management, aiming to estab ...

Core Viewpoint - Roche and Sanofi's latest earnings met expectations, with both companies emphasizing the importance of developing new drugs to counteract the impending "patent cliff" facing the pharmaceutical industry [1][2]. Roche - Roche's sales grew by 8% in the fourth quarter, driven by blockbuster drugs like Ocrevus and Tecentriq [5]. - The company forecasts profit growth to outpace sales growth by 2026, with adjusted earnings per share expected to grow by high single digits at constant currencies [5]. - Roche plans to launch up to 19 new medicines by the end of the decade, focusing on late-stage development [3]. - The company is entering the obesity market with its weight-loss candidate CT-388, which showed a 22.5% weight reduction in Phase 2 trials, comparable to competitors [10]. - Roche has partnered with Zealand Pharma to co-develop the drug petrelintide, aiming to invest in next-generation obesity treatments [11]. Sanofi - Sanofi reported a 13% sales growth in the fourth quarter at constant currencies, with earnings per share of 1.53 euros ($1.20), exceeding forecasts [6]. - The company anticipates sales growth in the high single digits for 2026, with profit growth expected to be slightly higher than revenue [8]. - Sanofi's growth was supported by new medicines and its drug Dupixent, which reached a new quarterly high [8]. - The company announced a 1 billion euro share buyback, but investor focus remains on its research and development efforts [8]. - The need to expand the pipeline will be a key topic in Sanofi's earnings call, highlighting long-term R&D spending and potential M&A activities [9].

Company Overview - Zealand Pharma A/S (ZLDPF) shares increased by 6.8% to close at $67.8, following a notable trading volume, contrasting with a 17.6% loss over the past four weeks [1][2] Pipeline Developments - The price increase is linked to growing investor optimism regarding the pipeline candidate petrelintide, aimed at treating overweight or obese individuals with type 2 diabetes. Additionally, the company is developing survodutide for similar patient groups, with several data readouts anticipated in 2026 [2] Financial Expectations - Zealand Pharma is projected to report a quarterly loss of $1.34 per share, reflecting a year-over-year decline of 127.1%. Expected revenues are $9.73 million, marking a significant increase of 654.3% compared to the same quarter last year [3] - The consensus EPS estimate for the upcoming quarter has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Zealand Pharma is categorized under the Zacks Medical - Biomedical and Genetics industry, where Day One Biopharmaceuticals, another company in the same sector, saw a 2.2% increase in its stock price, closing at $12.34, with a 25.7% return over the past month [5]

Core Viewpoint - Zealand Pharma is seeking partners for innovative weight loss treatments that target the brain directly, emphasizing the central nervous system's role in metabolic regulation and immune response [4][6]. Group 1: Strategic Collaborations - Zealand Pharma is exploring collaborations to develop therapies that can cross the blood-brain barrier, with a focus on "shuttle technology" to safely deliver drugs to the brain [4][6]. - The company has engaged in discussions with Roche and other institutions regarding brain-targeted research, acknowledging the high difficulty of these projects but recognizing their potential to fundamentally change metabolic disease treatment [6]. - Zealand recently announced a $20 million upfront payment to OTR Therapeutics, with a total potential of $30 million, to leverage its oral small molecule platform for discovering new metabolic disease therapies [8]. Group 2: Product Pipeline and Development - Zealand's pipeline includes the promising drug petrelintide, which is expected to show an average weight loss of 8.6% over 16 weeks in its Phase II trial, with results anticipated in mid-2026 [9]. - The company is also advancing the dual agonist survodutide in Phase III trials for obesity and MASH, alongside other projects targeting short bowel syndrome and congenital hyperinsulinemia [9]. - Zealand's strategy includes a roadmap titled "Metabolic Frontier 2030," aiming to launch five products by 2030, indicating a long-term vision for growth in the metabolic disease sector [9]. Group 3: Market Position and Future Outlook - Zealand's entry into oral small molecule collaborations is seen as a risk mitigation strategy amid rising competition in the oral weight loss drug market, particularly with Novo Nordisk's oral semaglutide awaiting regulatory approval [8]. - The company believes it has sufficient research capabilities and financial reserves to navigate uncertainties in the market, positioning itself for continuous iteration and improvement [9]. - Zealand's future innovations may include improving insulin sensitivity unrelated to weight and eventually directly modulating brain receptors, showcasing a commitment to long-term health impact [10].

Core Viewpoint - Zealand Pharma is seeking partners for innovative weight loss treatments that target the brain directly, emphasizing the central nervous system's role in metabolic regulation and immune response [4][6]. Group 1: Strategic Collaborations - Zealand is exploring collaborations to develop therapies that can cross the blood-brain barrier, with a focus on "shuttle technology" to safely deliver drugs to the brain [4][6]. - The company has engaged in discussions with Roche and other institutions regarding brain-targeted research, acknowledging the high difficulty of these projects but recognizing their potential to fundamentally change metabolic disease treatment [6]. - Zealand has entered a partnership with OTR Therapeutics, paying a $20 million upfront fee, potentially reaching $30 million, to leverage OTR's oral small molecule platform for new metabolic disease therapies [8]. Group 2: Product Pipeline and Development - Zealand's pipeline includes the promising drug petrelintide, which is expected to show an average weight loss of 8.6% over 16 weeks in its Phase II trial, with results anticipated in mid-2026 [9]. - The company is also advancing the dual agonist survodutide in Phase III trials for obesity and MASH, alongside other candidates targeting short bowel syndrome and congenital hyperinsulinism [9]. - Zealand's strategy includes a roadmap titled "Metabolic Frontier 2030," aiming to launch five products by 2030, indicating a long-term vision for growth in the metabolic disease sector [9]. Group 3: Market Position and Future Outlook - Zealand is aware of the competitive landscape in oral weight loss medications, particularly with Novo Nordisk's oral semaglutide awaiting regulatory approval, and is cautious about committing to outcomes without believing in their potential [8]. - The company has a robust research capability and financial reserves, allowing it to navigate uncertainties in the market while continuing to innovate [9]. - Zealand's future innovations may include improving insulin sensitivity unrelated to weight and directly modulating brain receptors, showcasing a commitment to long-term health impacts [10].

Zealand Pharma Capital Markets Day Summary Company Overview - **Company**: Zealand Pharma - **Event**: 2025 Capital Markets Day - **Date**: December 11, 2025 - **Focus**: Management of obesity and metabolic health pipeline Key Industry Insights - **Obesity Market Evolution**: The obesity market has significantly evolved, with key trends reinforcing Zealand Pharma's perspectives shared two years ago [2][12] - **Healthcare Crisis**: Over 1 billion people globally are living with obesity, creating a civilization-scale problem that requires innovative solutions beyond current GLP-1-based therapies [14][15] - **Consumer Engagement**: The consumer segment is rapidly growing, with nearly two-thirds of discussions initiated by consumers, indicating a shift towards consumer-driven treatment choices [40][41] Core Company Strategies - **Pipeline Development**: Zealand Pharma aims to maximize the value of petrelintide, an amylin analog, and invest significantly in its metabolic health pipeline, increasing research investments fivefold over the next five years [22][24] - **Partnership with Roche**: A 50/50 partnership with Roche is established to co-commercialize petrelintide, combining Zealand's biotech agility with Roche's pharmaceutical strength [18][19] - **Research Expansion**: A new research hub in Boston will complement the existing Copenhagen site, focusing on AI, machine learning, and novel chemistry approaches [22][23] Product Highlights - **Petrelintide**: Described as the "crown jewel," petrelintide is designed to help individuals feel full faster and is positioned as a foundational therapy for weight management [7][17] - **Survodutide**: A dual agonist targeting GLP-1 and glucagon receptors, showing promising phase two data for weight loss and metabolic health improvements [50][56] Clinical Insights - **Weight Maintenance Focus**: Emphasis on transitioning from weight loss to weight maintenance, addressing the need for durable therapies that help maintain weight loss [16][34] - **Real-World Data**: High discontinuation rates of current therapies highlight the need for better patient experiences and alternatives to GLP-1 therapies, which often lead to gastrointestinal side effects [44][46] Future Outlook - **2030 Ambition**: Zealand Pharma's "Metabolic Frontier" ambition includes five product launches and over ten clinical candidates by 2030, aiming to establish itself as a generational biotech company [22][24] - **Transformational Potential**: The partnership with Roche and the development of innovative therapies position Zealand Pharma to redefine obesity management and address significant unmet medical needs [18][19][22] Additional Considerations - **Cultural Commitment**: Zealand Pharma emphasizes its unique culture and commitment to agility and innovation, which are seen as critical to its success in the competitive biotech landscape [11][25] - **Healthcare System Impact**: The company recognizes the broader societal implications of obesity and the need for comprehensive solutions that address the healthcare crisis associated with it [15][12]

Core Insights - Zealand Pharma has announced a five-year strategy called "Metabolic Frontier 2030" to enhance its anti-obesity portfolio amid increasing competition in the market [2][3] - The company aims for five drug launches, at least ten clinical pipeline programs, and industry-leading cycle times by 2030 [2] - Zealand's shares have dropped 29% year-to-date, reflecting investor concerns about market fragmentation and competition [2] Company Strategy - The strategy will leverage strategic partnerships, accelerated drug development, and expanded research capabilities to create a valuable metabolic health pipeline [3] - Zealand Pharma is focusing on candidates with greater potential for clinical differentiation, having paused development of a dual agonist due to market saturation [8] Drug Development - One of Zealand's promising drugs, petrelintide, targets the pancreatic amylin hormone and has shown moderate side effects in early-stage trials [4] - Mid-stage data for petrelintide is expected early next year, while data for its dual GLP-1 agonist, survodutide, will be available throughout 2026 [4] Market Dynamics - Novo Nordisk and Eli Lilly currently dominate the weight loss drug market, with analysts predicting the market could reach $150 billion annually by the start of the next decade [5] - Eli Lilly has gained investor favor due to its effective weight loss drugs and diverse portfolio, while Novo Nordisk is experiencing significant stock declines [6][7] Competitive Landscape - Big Pharma companies like AstraZeneca, Amgen, and Pfizer are also entering the obesity drug market, aiming to capture market share from Lilly and Novo [9] - Analysts believe that while Lilly may hold over 50% of the global market share, this will stabilize as competitors launch next-generation drugs [10] Partnerships and Research - Zealand Pharma has entered an agreement with OTR Therapeutics to develop oral small molecule treatments for metabolic diseases, involving an upfront payment of $20 million and potential milestones worth up to $2.5 billion [11] - The company plans to open a new research site in Boston, combining its peptide drug expertise with AI-driven drug discovery [12]

Core Insights - Zealand Pharma aims to redefine weight management and establish leadership in metabolic health through its Metabolic Frontier 2030 strategy, focusing on innovative solutions for obesity and metabolic diseases [2][4][5] Company Strategy - The company plans to target five product launches and maintain a clinical pipeline of over ten programs by 2030, utilizing its peptide expertise and advanced research capabilities to enhance drug discovery [3][7] - Zealand Pharma will leverage strategic partnerships and advanced computational methods to accelerate drug development and expand its molecule-making toolbox [3][6] Research and Development - A new research site in Boston will integrate over 25 years of peptide expertise with AI-driven drug discovery and advanced automation, aiming to enhance the efficiency of drug development [6][7] - The company anticipates multiple clinical readouts in 2026, including Phase 2 data for petrelintide and Phase 3 data for survodutide [7] Leadership and Vision - The CEO, Adam Steensberg, emphasizes the company's commitment to transforming treatment approaches for obesity and metabolic diseases, moving beyond traditional weight loss methods to support overall well-being [4][5] - Zealand Pharma's strategy is designed to address significant healthcare challenges and foster innovation in metabolic health [5]

Summary of Zealand Pharma Conference Call Company Overview - **Company**: Zealand Pharma (OTCPK:ZLDP.Y) - **Focus**: Development of obesity treatments, particularly the amylin asset petrelintide Key Industry Insights - **Obesity Treatment Landscape**: Zealand Pharma aims to lead in a new category of obesity treatments with petrelintide, differentiating from established GLP-1 therapies [2][3] - **Partnership with Roche**: The collaboration is viewed as a shared commitment to advance obesity treatments, with Roche's interest stemming from the potential of petrelintide to provide effective weight loss in a more pleasant manner [2][3] Core Product Insights - **Petrelintide Mechanism**: The drug is designed to induce satiety, potentially leading to better patient adherence compared to GLP-1s, which often have gastrointestinal side effects that lead to discontinuation [4][5] - **Tolerability Profile**: Early clinical trials indicate a benign tolerability profile for petrelintide, with lower rates of nausea and gastrointestinal issues compared to GLP-1s [7][8] - **Weight Loss Expectations**: Zealand Pharma anticipates achieving a weight loss of 15%-20% in longer-term studies, with a focus on titration to manage dosing effectively [13][15] Competitive Landscape - **Comparison with Competitors**: The company acknowledges challenges faced by competitors like Eli Lilly, particularly regarding tolerability and dosing strategies. Zealand believes that proper titration can mitigate side effects and enhance weight loss outcomes [9][10][11] - **Market Dynamics**: The obesity treatment market is seen as a chronic therapy opportunity rather than an event-based approach, emphasizing the need for sustained patient adherence to achieve health outcomes [20][21] Financial and Strategic Outlook - **Funding and Investment**: The partnership with Roche provides significant upfront capital and milestone payments, allowing Zealand to invest in both the petrelintide program and early research pipelines [26][27] - **Long-term Vision**: Zealand aims to evolve into a generational biotech company, expanding its portfolio beyond petrelintide and focusing on innovations in metabolic diseases [27][28] Pipeline and Future Developments - **Survodutide**: Zealand expects significant developments in the Survodutide program, partnered with Boehringer Ingelheim, with a focus on liver health and obesity [31][34] - **Discontinuation of Dapaglutide**: The decision to pause development of Dapaglutide reflects a strategic focus on more promising assets within the pipeline [36] Conclusion - Zealand Pharma is positioned to capitalize on the growing obesity treatment market through innovative therapies like petrelintide, strategic partnerships, and a commitment to addressing chronic obesity as a significant healthcare challenge. The company is focused on maintaining a strong R&D foundation while exploring commercial opportunities in collaboration with larger pharmaceutical partners.

Core Insights - Zealand Pharma is advancing its clinical programs, particularly with petrelintide and survodutide, and is preparing for a catalyst-rich 2026 with significant data readouts expected [3][8][16] Financial Performance - For the first nine months of 2025, Zealand Pharma reported revenues of DKK 9,146 million, a substantial increase from DKK 54 million in the same period of 2024 [4] - The net operating expenses for the year-to-date were DKK 1,479 million, up from DKK 919 million in 2024, excluding transaction-related costs of DKK 196 million associated with the Roche partnership [4][5] - The operating result for the period was DKK 7,666 million, compared to a loss of DKK 873 million in the previous year [4] Clinical Developments - The company achieved a key milestone in the petrelintide Phase 2 ZUPREME-1 trial, with the last participant completing the 28-week primary endpoint visit, paving the way for topline data in H1 2026 [6][8] - Survodutide is approaching Phase 3 data in H1 2026, following the completion of the 76-week SYNCHRONIZETM-1 trial [8] - Zealand Pharma is also preparing to report topline data from the first-in-human trial of ZP9830 in the first half of 2026 [13] Strategic Focus - The company is focusing on its research strategy to lead innovation in obesity treatments, with plans to initiate several Phase 2 and Phase 3 trials in 2026 [3][16] - Development of dapiglutide has been paused to concentrate resources on programs with higher potential for clinical differentiation [15][17] Upcoming Events - Zealand Pharma will host a Capital Markets Day on December 11, 2025, to discuss upcoming data readouts and its research strategy [16][19]