Aligning with Policy: The announcement's timing, following a deal with the current administration to improve drug affordability, is a shrewd political maneuver. By proactively lowering consumer costs, Novo Nordisk builds political goodwill and may mitigate the risk of more stringent government-mandated price controls. This also favorably positions the company for future negotiations to expand Wegovy coverage into the massive Medicare market, creating another powerful, long-term growth driver.Countering the ...

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 Viewpoint - Lars Rebien Sorensen has returned as chairman of Novo Nordisk A/S amid heightened competition with Pfizer Inc, particularly following Pfizer's recent acquisition of Metsera Inc for $10 billion, which positions both companies as direct rivals in the obesity treatment market [1][2]. Company Developments - Sorensen's return comes after a tumultuous period for Novo, including a significant board restructuring where over half of the supervisory board resigned due to disagreements on the pace of change within the company [3]. - Sorensen was approved to lead the supervisory board with over 93% of proxy and postal votes, but the board will need to nominate two additional candidates at the next shareholder meeting in March due to Dolsten's withdrawal [4]. - The company has announced layoffs affecting 11% of its workforce and has discontinued long-term projects, indicating a shift in strategy under the new leadership of Sorensen and CEO Mike Doustdar [12]. Market Position and Strategy - Novo is currently facing challenges in the obesity market, having lost its lead to Eli Lilly & Co, and is struggling with the performance of its next-generation drug CagriSema [9]. - The company is criticized for not capitalizing on its first-mover advantage and is now tasked with developing a sustainable strategy to regain market share [10][11]. - Investors are concerned about the aggressive approach taken by the new leadership, particularly in light of the failed attempt to disrupt Pfizer's acquisition of Metsera, which has raised questions about the company's risk management [6][8]. Investor Sentiment - Some minority investors, including Norway's sovereign wealth fund and CalSTRS, have expressed intentions to reject the board's revamp, citing concerns over transparency and accountability [5]. - The influential proxy adviser Institutional Shareholder Services Inc. has recommended that shareholders abstain from supporting the board overhaul, indicating a lack of confidence in the current leadership's direction [5].

Core Viewpoint - The acquisition battle for the weight loss startup Metsera has concluded with Pfizer agreeing to acquire the company for $10 billion, while Novo Nordisk's participation raises questions about its confidence in its own weight loss drug pipeline [3][4]. Group 1: Acquisition Details - Pfizer's offer for Metsera was $100 per share, which is approximately 19% higher than Novo Nordisk's bid of $56.50 per share [6]. - The enterprise value of Pfizer's offer is $4.90 billion, while Novo Nordisk's is $6.00 billion, indicating a 22% difference in valuation [6]. - The acquisition is subject to antitrust review, which may pose significant challenges due to overlapping product pipelines [7]. Group 2: Product Pipeline Overlap - Both companies have overlapping products in their pipelines, particularly in GLP-1 receptor agonists, which raises concerns about Novo Nordisk's rationale for pursuing the acquisition [7][8]. - Novo Nordisk plans to submit its own GLP-1 drug, CagriSema, for approval in 2026, alongside several other drugs currently in development [7]. Group 3: Metsera's Drug Performance - Metsera's MET-097i demonstrated a 14.1% weight loss in the VESPER-1 trial, with a low treatment discontinuation rate of 2.9% [9][11]. - The drug's favorable tolerability profile and the absence of dose titration requirements may provide a competitive edge in the market [9]. - MET-233i, another drug from Metsera, showed an 8.4% weight loss in its Phase I trial, outperforming competitors like Roche's petrelintide [12].

3 November 2025 | 6:38AM EST Equity Research HEALTHCARE: PHARMACEUTICALS The Obesity Evolution: The Emerging Amylin Field in Focus Heading In Obesity Week 2025 In this note we provide a brief update on obesity datasets we are monitoring headed into year-end. Near-term, at this week's Obesity Week conference (November 4th-7th) in Atlanta, GA we expect heightened focus on the emerging amylin field in the context recent deal activity (see: Novo Nordisk's unsolicited bid for Metsera). Datasets in focus include ...

Core Insights - Novo Nordisk's experimental obesity drug CagriSema has shown significant blood pressure reduction in a late-stage trial, indicating potential health benefits beyond weight loss [1] Group 1 - The late-stage trial results suggest that CagriSema may provide cardiovascular benefits, which could enhance its marketability [1] - Novo Nordisk aims to demonstrate that CagriSema can address multiple health issues associated with obesity, potentially expanding its therapeutic applications [1] - The company is focusing on the broader implications of its obesity treatment, which may attract more attention from healthcare providers and patients [1]

Core Insights - Novo Nordisk presented new post hoc analyses from the phase 3 REDEFINE 1 trial for CagriSema, an investigational treatment for obesity, highlighting its potential cardiovascular risk reduction effects [1][15]. Group 1: Clinical Efficacy - CagriSema treatment resulted in a reduction of systolic blood pressure by -10.9 mmHg over 68 weeks, outperforming semaglutide (–8.8 mmHg) and placebo (–2.1 mmHg) [2][6]. - Approximately 40% of participants on blood pressure medications were able to reduce or stop their medication during the trial [2][6]. - CagriSema demonstrated a significant reduction in high-sensitivity C-reactive protein (hsCRP) by –68.9%, compared to –55.4% with semaglutide and –16.0% with placebo, indicating anti-inflammatory effects [3][6]. Group 2: Cardiovascular Risk - The treatment reduced the proportion of individuals at intermediate-to-high risk of developing atherosclerotic cardiovascular disease (ASCVD) within the next 10 years [6]. - A dedicated trial (REDEFINE 3) is ongoing to further investigate CagriSema's effects on cardiovascular outcomes in patients with established cardiovascular disease [4][6]. Group 3: Safety Profile - Safety data from the REDEFINE 1 trial indicated low discontinuation rates due to adverse events, with 6% for CagriSema compared to 3.7% for placebo [4]. - Adverse events were primarily gastrointestinal, with nausea (55% vs. 12.6% for placebo), constipation (30.7% vs. 11.6%), and vomiting (26.1% vs. 4.1%), mostly mild-to-moderate in severity [4]. Group 4: Product Information - CagriSema is a fixed-dose combination of cagrilintide (2.4 mg) and semaglutide (2.4 mg), being investigated for adults with overweight or obesity and type 2 diabetes [7][8]. - The REDEFINE 1 trial involved 3,417 adults with obesity or overweight and one or more obesity-related comorbidities, without type 2 diabetes [8].

Financial Data and Key Metrics Changes - The company reported a 15% top-line growth year-to-date and an 11% growth for the quarter, indicating strong momentum in its financial performance [5][21] - The guidance for top-line growth for 2025 has been narrowed to a range of 8%-11%, with corresponding adjustments to operating profit growth [21] Business Line Data and Key Metrics Changes - The diabetes segment experienced a 10% growth, while obesity care saw a remarkable 41% growth, with 83% of this growth coming from international operations (IO) and 24% from the U.S. [11] - Rare disease products returned to normal production levels, growing 13% in a balanced manner between IO and the U.S. [11] Market Data and Key Metrics Changes - The U.S. market for anti-obesity medications continues to expand, with a significant increase in out-of-pocket expenses for patients, rising from 4% to over 10% in just nine months [12] - The company is currently addressing only 3-4 million patients in the obesity market, compared to an estimated 100 million potential patients [12] Company Strategy and Development Direction - The company is sharpening its strategy to focus on treating patients with obesity and diabetes, emphasizing the overlap of these conditions with other comorbidities [8][10] - The acquisition of Akero is part of the strategy to deepen its focus on metabolic diseases, particularly MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in the obesity market, highlighting the significant unmet needs and the company's commitment to expanding its product portfolio [9][14] - The company is preparing for the launch of oral semaglutide, which is expected to capture a significant portion of the market due to its unique profile [96][97] Other Important Information - The company is facing regulatory challenges regarding the Metsera acquisition, but remains confident in the quality of the portfolio and its potential [59][68] - There are ongoing discussions about the competitive landscape in the U.S. for GLP-1 products, with management noting a slight decline in Ozempic scripts but a belief in continued growth potential outside the U.S. [82][84] Q&A Session Summary Question: What do you expect to learn from the amycretin trials? - Management indicated that they will not progress to phase III trials without clear differentiation in efficacy, safety, or scalability [25] Question: Can you explain the recent pricing trends for GLP-1 products? - Management confirmed that pricing for Ozempic is expected to decline by 10%-15% year-on-year, while Wegovy's pricing has also seen a decrease [27][28] Question: How are you addressing the consumerization of the sales force? - The company is focusing on understanding patient needs and behaviors, emphasizing the importance of direct purchasing channels and expanding product offerings [31][36] Question: What is the outlook for revenue growth in 2026? - Management refrained from providing specific guidance for 2026 but highlighted the potential of the Wegovy pill launch and ongoing pipeline developments as future growth drivers [49][51] Question: What if the FTC blocks the Metsera acquisition? - Management expressed confidence in the acquisition's merits and readiness to discuss its benefits with the FTC [56][59] Question: Are there any supply limitations for the oral semaglutide? - Management reassured that there are no anticipated supply limitations for the oral semaglutide launch [101]

Financial Data and Key Metrics Changes - The company reported a 15% top-line growth year-to-date and an 11% growth for the quarter, indicating strong momentum in its R&D pipeline and business development activities [4][20]. - The guidance for top-line growth for 2025 has been narrowed to a range of 8-11%, with corresponding adjustments to operating profit growth [20]. Business Line Data and Key Metrics Changes - The diabetes segment experienced a 10% growth, while obesity care saw a remarkable 41% growth, with 83% of this growth coming from International Operations (IO) and 24% from the US [10]. - Rare disease products returned to normal production levels, growing 13% in a balanced manner between IO and the US [10]. Market Data and Key Metrics Changes - The US market for anti-obesity medications continues to expand, with a significant increase in out-of-pocket expenses for patients, rising from 4% to over 10% in just nine months [11]. - The company is addressing a market of approximately 100 million patients in the US for obesity treatment, with only 3-4 million currently being treated [11]. Company Strategy and Development Direction - The company is sharpening its strategy to focus on treating patients with obesity and diabetes, emphasizing the overlap with comorbidities such as MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) [6][7]. - Recent acquisitions, including that of Akero, are aimed at deepening the company's focus on core therapy areas and addressing unmet needs in comorbidities associated with obesity and diabetes [7][15]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in the obesity market, highlighting the significant unmet needs and the company's strategic focus on expanding its product portfolio [11][13]. - The company acknowledged challenges in the US market, including pricing pressures and competition, but remains committed to leveraging its pipeline and product offerings to drive future growth [20][49]. Other Important Information - The company is preparing for the regulatory submission of new products, including the oral semaglutide and MyMADE for rare diseases, which are expected to contribute to future revenue growth [19][50]. - Management emphasized the importance of understanding patient behaviors and needs in the consumer market, particularly in relation to comorbidities and treatment formats [35][100]. Q&A Session Summary Question: What do you expect to learn from the amycretin trials? - Management stated that they will not progress to phase three without clear differentiation in efficacy, safety, or scalability, and they are awaiting confirmation from phase two data [23]. Question: What are the pricing trends for GLP-1 medications? - Management indicated that pricing for Ozempic is expected to remain stable, with a year-on-year decrease of about 10-15%, while Wegovy's pricing has seen a decline in Q3 [26][27]. Question: How are you addressing the consumerization of the sales force? - The company is focusing on understanding patient needs and behaviors, emphasizing the importance of product formats and direct purchasing channels [30][35]. Question: What is the outlook for the UK market? - Management noted that the UK market is competitive and price-sensitive, but they are seeing strong performance from their products despite pricing pressures [43]. Question: Can you discuss the Metsera acquisition and potential FTC challenges? - Management expressed confidence in the acquisition's merits and their readiness to discuss it with the FTC, emphasizing the quality of the portfolio [52][56]. Question: What is the expected impact of the oral semaglutide launch? - Management believes that the oral market represents a significant opportunity, with expectations of capturing a substantial share due to its unique profile [95][100].

Financial Data and Key Metrics Changes - In the first nine months of 2025, the company achieved 15% sales growth and 10% operating profit growth, with guidance narrowed to 8-11% for sales and 4-7% for operating profit due to expected lower growth in GLP-1 treatments for diabetes and obesity [7][35][38] - The gross margin decreased to 81.0% from 84.6% in 2024, primarily due to one-off restructuring costs and impairments [35] - Net profit increased by 4%, and diluted earnings per share rose to DKK 16.99 [37] Business Line Data and Key Metrics Changes - GLP-1 sales in diabetes increased by 10%, while insulin sales grew by 3% [14] - Obesity care sales surged by 41%, with US operations growing by 24% and international operations by 83% [14] - Rare disease sales increased by 13%, driven by a 14% increase in the US [14] Market Data and Key Metrics Changes - In international operations, GLP-1 diabetes sales increased by 10%, with a notable growth in China [16] - The combined diabetes and obesity GLP-1 market share remains at 68% in international operations [17] - Wegovy sales reached approximately DKK 20 billion, growing at 168% across all regions [16] Company Strategy and Development Direction - The company is sharpening its focus on diabetes and obesity, discontinuing non-core assets and reallocating resources to areas aligned with its strengths [10][11] - A company-wide transformation program aims to simplify operations and reallocate capital towards high-growth opportunities, expecting annual savings of approximately DKK 8 billion by the end of 2026 [12] - The company is pursuing acquisitions to enhance its R&D portfolio, including a proposal to acquire Medcera for $6.7 billion [24] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the loss of market share in the GLP-1 market and emphasized the need for strategic initiatives to regain momentum [46][50] - The company remains optimistic about the long-term potential in the diabetes and obesity markets, despite current competitive pressures [78] - Future growth is expected to be impacted by the loss of exclusivity in certain markets and increased R&D costs from acquisitions [92] Other Important Information - The company has submitted Mim8 for regulatory approval in both the US and EU [8] - The FDA approved Wegovy for the treatment of MASH in the US, expanding its market potential [20] - The company anticipates a regulatory decision regarding the Wegovy Pill by the end of 2025 [32] Q&A Session Summary Question: Market share loss in GLP-1 market - Management acknowledged the significant loss of market share and discussed strategic initiatives to expand the market and regain momentum [46][50] Question: Capital allocation and dividend payout - The CFO confirmed a consistent capital allocation framework prioritizing business investment, dividend payments, and potential share buybacks [52][53] Question: Differentiation of Medcera assets - Management expressed excitement about the Medcera acquisition, highlighting the complementary nature of its assets to the existing pipeline [60][61] Question: Medicare opportunities and IRA risks - Management emphasized the importance of Medicare coverage for obesity treatments and acknowledged the potential risks associated with the Inflation Reduction Act [67][70] Question: Device strategy setbacks - Management discussed setbacks with the Wegovy FlexTouch device and plans to explore other device options for market entry [81]