NewAmsterdam Pharma Company (NasdaqGM:NAMS) FY 2025 Conference December 03, 2025 03:15 PM ET Company ParticipantsMichael Davidson - CEOGeoff Meacham - Global Head of Biotech and Pharma ResearchIan Somaiya - CFOGeoff MeachamYeah, the Global Healthcare Conference at Citi. My name's Geoff Meacham. I am the head of healthcare, global head of biotech, pharma research. Fun, fun. We're thrilled today to have NewAmsterdam Pharma. So we have Michael Davidson, CEO. We have Ian Somaiya, CFO. Guys, thanks a lot for the ...

Financial Data and Key Metrics Changes - The company reported a significant milestone in 2025, completing three phase 3 trials for its drug, which is expected to lead to regulatory submissions globally [3] - The BROADWAY trial demonstrated a 21% relative risk reduction in major adverse cardiac events (MACE) among 2,500 patients, indicating strong efficacy [3][4] - The drug showed a 50% reduction in Lp(a) levels, a key target for cardiovascular health, which is not addressed by statins [4][6] Business Line Data and Key Metrics Changes - The drug, obicetrapib, is positioned as a differentiated therapy due to its ability to lower Lp(a) and reduce diabetes risk, alongside LDL cholesterol lowering [4][6] - The company is focusing on the Alzheimer's prevention benefit of obicetrapib, which has shown promising results in patients with the APOE4 gene variant [5][17] Market Data and Key Metrics Changes - The company anticipates a significant increase in the patient population needing effective LDL lowering therapies due to new guidelines emerging from studies like VESALIUS, which demonstrated mortality benefits from lowering LDL below 55 [56][57] - The partnership with Menarini is expected to enhance market penetration in Europe, leveraging their extensive sales force of 6,000 representatives [53] Company Strategy and Development Direction - The company aims to position obicetrapib as the go-to therapy for patients needing LDL lowering, particularly those with high Lp(a) levels, while also addressing diabetes and Alzheimer's prevention [58][62] - The strategy includes conducting additional studies to further validate the drug's benefits and potentially accelerate its approval process [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing PREVAIL study, which is expected to provide critical data for regulatory submissions and market positioning [8][12] - The management highlighted the importance of addressing skepticism in the medical community regarding CETP inhibitors and emphasized the need for robust data from PREVAIL to support the drug's launch [81] Other Important Information - The company is planning to conduct economic outcome studies to support payer arguments and demonstrate the cost-effectiveness of obicetrapib [76] - The management noted that the Alzheimer's benefit is gaining traction among lipidologists and cardiologists, which could enhance the drug's acceptance in the market [87] Q&A Session Summary Question: What is the expected peak sales potential for obicetrapib? - Management indicated that consensus estimates hover around $2-3 billion, while they believe the peak sales potential could exceed $8 billion, largely due to the drug's cardiovascular benefits [42] Question: How does the company plan to address global pricing strategies? - The company aims to harmonize pricing globally, learning from past pricing strategies of other companies, and ensuring broad access at launch [71][72] Question: What are the key differentiators of obicetrapib compared to other therapies? - The drug's ability to lower Lp(a) significantly, alongside its safety and tolerability profile, positions it as a preferred option for patients needing LDL lowering [62][68]

Financial Data and Key Metrics Changes - The company reported a significant reduction in major adverse cardiac events (MACE) by 21% in the BROADWAY trial, which included 2,500 patients, indicating strong efficacy of their drug [4][7] - The drug demonstrated a 50% reduction in Lp(a) levels, a key target for cardiovascular health, which is not addressed by statins [5][58] Business Line Data and Key Metrics Changes - The BROADWAY trial results have positioned the drug as a differentiated therapy in the lipid-lowering market, with additional benefits in diabetes risk reduction and potential Alzheimer's prevention [6][21] - The company is preparing for the PREVAIL study, which is expected to provide further validation of the drug's efficacy and safety [9][14] Market Data and Key Metrics Changes - The company anticipates a significant increase in the patient population needing aggressive LDL treatment due to new guidelines emerging from studies like VESALIUS, which showed mortality benefits from lowering LDL below 55 [54][55] - The partnership with Menarini is expected to enhance market access in Europe, leveraging their extensive sales force of 6,000 representatives [52][50] Company Strategy and Development Direction - The company aims to position its drug as the go-to option for patients requiring LDL lowering, emphasizing its unique benefits beyond traditional lipid-lowering therapies [56][57] - Future studies are planned to explore the drug's effects on Alzheimer's and diabetes, with a focus on expanding its therapeutic indications [76][78] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the drug's potential to address unmet medical needs in cardiovascular health and Alzheimer's prevention, highlighting the growing recognition of its benefits in the medical community [8][20] - The company is committed to maintaining a strong adherence to study protocols in ongoing trials, which is crucial for regulatory approval and market success [9][13] Other Important Information - The company has published significant findings in reputable journals, enhancing its credibility and visibility in the medical community [50][19] - The management is exploring partnerships for funding large-scale studies to mitigate financial risks associated with drug development [31][34] Q&A Session Summary Question: What is the expected impact of the PREVAIL study on the drug's market potential? - Management indicated that the PREVAIL study is crucial for validating the drug's efficacy and will inform the timing of regulatory filings for U.S. approval [14][15] Question: How does the company plan to address skepticism regarding CETP inhibitors? - The management acknowledged the need to address skepticism and emphasized the importance of robust data from the BROADWAY trial to build confidence among healthcare providers [78][50] Question: What are the anticipated guidelines for LDL treatment following recent studies? - Management expects that new guidelines will significantly increase the number of patients requiring treatment, particularly those with atherosclerotic disease [54][55]

Core Insights - Novo Nordisk's Alzheimer's trials were highly anticipated but ultimately deemed unsuccessful, highlighting the challenges in developing effective treatments for Alzheimer's disease [1] - Despite the setback, there remains ongoing interest in GLP-1 drugs, which are primarily known for their use in diabetes and obesity management, and their potential implications for other conditions [1] Company Summary - Novo Nordisk is recognized for its blockbuster drugs Ozempic and Wegovy, which have significantly impacted the diabetes and obesity markets [1] - The company's recent trials for Alzheimer's disease were a long shot, indicating the high-risk nature of expanding into new therapeutic areas [1] Industry Summary - The failure of the Alzheimer's trials raises questions about the viability of GLP-1 drugs in treating neurodegenerative diseases, suggesting a need for further research and exploration in this area [1] - The ongoing interest in GLP-1 drugs reflects a broader trend in the pharmaceutical industry towards repurposing existing medications for new therapeutic uses [1]