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]

Zealand Pharma's Strategic Vision - Zealand Pharma aims to redefine obesity care and build a generational biotech company in metabolic health[7, 18] - The company plans to launch 5 products in 5 years and have 10+ clinical programs in metabolic health by 2030[19] - Key catalysts include Survodutide Phase 3 obesity data in 2029/2030 and Petrelintide Phase 2 data and Phase 3 initiation[20] Addressing Obesity and Metabolic Health - Over 1 billion people are living with obesity today, requiring a civilization-scale health shift[9] - The GLP-1 revolution has changed expectations, proving obesity is drug treatable and resetting expectations for patients, systems, and markets[10, 11] - By 2030, an estimated 50% of adults globally are expected to live with overweight or obesity[40] - Only ~3% of eligible people in the U S are treated with GLP-1s, and ~12% of Americans have been exposed to GLP-1s[45] Survodutide's Potential - Survodutide, a glucagon/GLP-1 dual agonist, offers coordinated regulation of energy expenditure and energy intake[100] - In a Phase 2 trial, Survodutide dose-dependently reduced body weight by up to 18 7% in 46 weeks[106] - Survodutide also demonstrated breakthrough liver fibrosis improvement in MASH in a Phase 2 trial[128] Petrelintide as a Foundational Therapy - Petrelintide, a long-acting amylin analog, is designed for high-quality, durable weight loss and can be used stand-alone or in combination with CT-388 (GLP-1/GIP)[13] - Petrelintide holds the potential to deliver ~15–20% weight loss with a benign tolerability profile[231] - A Phase 2 trial with Petrelintide/CT-388 is planned for initiation in H1 2026[240]

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 - Roche has received CE Mark approval for its mass spectrometry reagent pack for antibiotics drug monitoring, establishing the broadest in-vitro diagnostics (IVD) menu for automated mass spectrometry platforms with 39 frequently tested targets [1][7]. Group 1: Product and Technology - The cobas® Mass Spec solution Ionify® reagent portfolio includes tests for therapeutic drug monitoring for immunosuppressants and antibiotics, as well as steroid hormones and vitamin D metabolites, enabling a transition to fully automated and standardized solutions [2][4]. - The high specificity, sensitivity, and accuracy of mass spectrometry are recognized as the diagnostic 'gold standard' for various clinical situations, making it accessible to routine laboratories through the cobas Mass Spec solution [4][7]. - The automated mass spectrometry platform reduces turnaround times and supports faster, standardized, high-quality care by replacing labor-intensive manual workflows [7]. Group 2: Market Availability and Regulatory Status - The cobas Mass Spec solution is currently available in selected markets that accept the CE mark, including the UK, Canada, and Japan, and has achieved "moderate complexity" categorization under CLIA in the US [3]. - Roche is actively working with regulatory authorities worldwide to expand the availability of its systems and assays [3]. Group 3: Awards and Recognition - In July 2025, the cobas Mass Spec solution was awarded the Best New Clinical Diagnostics Instrumentation of 2024 in the Scientists' Choice Awards® 2025, highlighting its innovation in the clinical diagnostics field [6]. Group 4: Company Overview - Roche, founded in 1896 in Basel, Switzerland, has grown into the world's largest biotechnology company and a leader in in-vitro diagnostics, focusing on developing innovative medicines and diagnostics to improve global healthcare [8].

Core Viewpoint - Roche has received CE Mark approval for its mass spectrometry reagent pack for antibiotics drug monitoring, establishing the broadest in-vitro diagnostics (IVD) menu for automated mass spectrometry platforms with 39 frequently tested targets [1][7]. Group 1: Product and Technology - The cobas® Mass Spec solution Ionify® reagent portfolio includes tests for therapeutic drug monitoring for immunosuppressants and antibiotics, as well as steroid hormones and vitamin D metabolites, enabling a transition to fully automated and standardized solutions [2][4]. - The high specificity, sensitivity, and accuracy of mass spectrometry are recognized as the diagnostic 'gold standard' for various clinical situations, making it accessible to routine laboratories through the cobas Mass Spec solution [4][7]. - The automated mass spectrometry platform reduces turnaround times and supports faster, standardized, high-quality care by replacing labor-intensive manual workflows [7]. Group 2: Market Availability and Regulatory Status - The cobas Mass Spec solution is currently available in selected markets accepting the CE mark, including the UK, Canada, and Japan, and has achieved "moderate complexity" categorization under CLIA in the US [3]. - Roche is actively working with regulatory authorities worldwide to expand the availability of its systems and assays [3]. Group 3: Future Developments - Roche is committed to expanding its mass spectrometry menu with additional assays, including the first panel for drugs of abuse testing and further therapeutic drug monitoring parameters in the coming years [2][7].

Core Insights - Giredestrant has demonstrated a 30% reduction in the risk of disease recurrence or death when compared to standard-of-care endocrine therapy according to the company [1] Company Summary - Giredestrant is positioned as a significant advancement in treatment options, showing improved efficacy over traditional therapies [1]

Roche’s experimental pill reduced the risk of an invasive return of a form of breast cancer in a study that underscores the drug’s blockbuster potential https://t.co/3uFkpw9GAS ...

Core Insights - Genentech, a member of the Roche Group, announced positive data from the Phase III lidERA Breast Cancer study evaluating giredestrant as an adjuvant endocrine treatment for early-stage breast cancer [1] Group 1: Study Results - The interim analysis indicated that adjuvant giredestrant significantly reduced the risk of invasive disease [1]

Core Insights - Roche announced positive results from the phase III lidERA Breast Cancer study, showing that giredestrant significantly reduced the risk of invasive disease recurrence or death by 30% compared to standard-of-care endocrine therapy [1][2][6] - Giredestrant demonstrated a 31% risk reduction in distant recurrence-free interval, indicating its potential as a new standard-of-care treatment for ER-positive early-stage breast cancer [2][4][6] - The study involved over 4,100 patients and highlighted the urgent need for more effective and tolerable endocrine therapies in early ER-positive breast cancer [3][7] Company Overview - Roche has been advancing breast cancer research for over 30 years and is committed to delivering innovative medicines to patients with ER-positive breast cancer [5][13] - Giredestrant is the first oral selective estrogen receptor degrader (SERD) to show superior invasive disease-free survival in the adjuvant setting, marking a significant advancement in endocrine therapy [4][6] - The company is pursuing a comprehensive clinical development program for giredestrant across multiple treatment settings and lines of therapy [10][5] Industry Context - ER-positive breast cancer accounts for approximately 70% of breast cancer cases, with a significant portion diagnosed at an early stage [3][11] - Up to one-third of patients experience recurrence after adjuvant endocrine therapy, highlighting the need for improved treatment options [3][12] - The burden of breast cancer continues to grow globally, with 2.3 million women diagnosed and 670,000 deaths annually, making it a critical area for research and development [10][12]

Core Insights - Roche announced positive results from the phase III lidERA Breast Cancer study, demonstrating that giredestrant significantly reduces the risk of invasive disease recurrence or death by 30% compared to standard-of-care endocrine therapy [1][2][5] Group 1: Study Results - At the three-year mark, 92.4% of patients treated with giredestrant were alive and free of invasive disease, compared to 89.6% in the standard-of-care endocrine therapy group [2][5] - Giredestrant also showed a 31% risk reduction in distant recurrence-free interval, with a hazard ratio of 0.69 [2][3] - The efficacy of giredestrant was consistent across all clinically relevant subgroups, and adverse events were manageable and aligned with its known safety profile [2][3] Group 2: Clinical Significance - Giredestrant is the first oral selective estrogen receptor degrader (SERD) to demonstrate superior invasive disease-free survival in the adjuvant setting, marking a significant advancement in endocrine therapy for breast cancer in over 20 years [3][5] - The lidERA study results highlight giredestrant's potential to become a new standard-of-care endocrine therapy for early-stage ER-positive breast cancer, where the chance for cure is highest [2][3] Group 3: Market Context - Approximately 70% of breast cancer cases are ER-positive, with many patients experiencing recurrence after adjuvant endocrine therapy, underscoring the need for more effective and tolerable treatment options [2][8] - Roche's commitment to advancing breast cancer research spans over 30 years, focusing on innovative therapies to address the complexities of various breast cancer subtypes [9][10]