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]

Summary of NewAmsterdam Pharma Company Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NasdaqGM:NAMS) - **Event**: 2025 Conference on November 12, 2025 - **Key Speakers**: CEO Michael Davidson, CFO Ian Somaiya Industry Insights - **Industry**: Lipid management and cardiovascular health - **Recent Event**: Discussion of the Freselius trial presented at the American Heart Association (AHA) conference, highlighting significant advancements in lipid treatment guidelines Core Points and Arguments 1. **Freselius Trial Results**: - Reported a 25% reduction in three-point MACE and a mortality benefit, which is a significant improvement over the previous FOURIER trial that showed only a 15% relative risk reduction without mortality benefit [2][3] - The trial's findings are expected to broaden the population guidelines for LDL cholesterol management, suggesting targets below 55 mg/dL, potentially even 40 mg/dL [3][4] 2. **PREVAIL Trial Design**: - The PREVAIL trial is designed to run longer (4.6 years) to capture adequate event data, similar to the successful approach of the Freselius trial [4][5] - The trial aims to validate the LDL-lowering benefits and their correlation with reduced myocardial infarction rates [5] 3. **Market Expansion**: - The new guidelines will effectively double the market for LDL-lowering treatments, as they will include patients with atherosclerotic disease regardless of prior heart attacks or strokes [9] 4. **Oral PCSK9 Developments**: - Merck's oral PCSK9 treatment shows promise but has limitations similar to Rybelsus, which may affect patient adherence [11][12] - NewAmsterdam believes its fixed-dose combination (FDC) will achieve better LDL lowering with easier administration [12] 5. **BROADWAY Trial Outcomes**: - NewAmsterdam's BROADWAY trial demonstrated a 21% MACE benefit, suggesting that their drug offers additional benefits beyond LDL lowering [14][24] - The company is optimistic about matching or exceeding this benefit in the PREVAIL trial [24] 6. **Regulatory Strategy**: - NewAmsterdam plans to engage with the FDA regarding the timing of filing for PREVAIL outcomes data, which could be included in the product label [19] - The European filing by partner Menarini has been accepted, with expected approval in the second half of next year [19] 7. **LPL-A and Alzheimer's Research**: - The company is exploring the potential of obicetrapib in treating Alzheimer's, particularly in high-risk populations [47][48] - There is significant interest from the Alzheimer's community regarding the drug's potential benefits [48] 8. **Market Opportunity**: - The lipid market is substantial, with 30 million individuals in the U.S. diagnosed with hypercholesterolemia, many not at treatment goals [42] - NewAmsterdam estimates an $8 billion market opportunity for its drug, supported by the ability to treat a wide range of patients with elevated LDL and LPL-A [42][43] 9. **Competitive Landscape**: - The company acknowledges the presence of other PCSK9 therapies but believes its product offers superior benefits and ease of use [16][45] - The evolving landscape of lipid treatments, including oral options, is expected to expand the overall market rather than cannibalize existing products [45] Additional Important Insights - **Patient Compliance**: NewAmsterdam is actively monitoring trial execution metrics and ensuring high patient compliance through site visits and support [37][39] - **Future Directions**: The company is committed to launching obicetrapib independently to maximize value and is optimistic about its strategic position in the lipid space [51]

Summary of NewAmsterdam Pharma Conference Call Company Overview - **Company**: NewAmsterdam Pharma (NasdaqGM:NAMS) - **Event**: FY Conference on November 11, 2025 Key Industry Insights - **Lipid Management**: The conference highlighted significant advancements in lipid management, particularly in the context of cardiovascular disease prevention. The recent American Heart Association (AHA) meeting emphasized the importance of LDL lowering and its correlation with mortality benefits, which is expected to shift treatment guidelines towards more aggressive LDL targets [6][54]. Core Points Discussed 1. **Mortality Benefit Evidence**: New studies have shown that aggressive LDL lowering can lead to mortality benefits, particularly in broader high-risk populations, which opens up new market opportunities for NewAmsterdam's products [6][54]. 2. **Prevail Study Design**: The Prevail study is designed to track event rates similar to previous successful studies, with a focus on achieving a significant reduction in cardiovascular events. The company is confident in the study's design and its potential outcomes [20][21][12]. 3. **Market Competition**: The competitive landscape includes Merck's oral PCSK9 inhibitor, which has shown promising LDL lowering results. However, NewAmsterdam believes its product, Obsettra, offers unique benefits, including Lp(a) lowering and potential Alzheimer's disease benefits, which could differentiate it in the market [13][15][47]. 4. **Regulatory Strategy**: NewAmsterdam plans to align its NDA submission with the completion of the Prevail study to ensure that the most relevant data is available at launch. The timing of the NDA submission is contingent on event tracking and FDA feedback [41][42][43]. 5. **Future Studies**: Additional studies, including Rubin and Rembrandt, are planned to further explore the drug's benefits in specific populations, particularly those with high Lp(a) levels and diabetes [44][45]. Additional Important Insights - **Market Growth Potential**: Analysts predict a significant market growth for lipid-lowering therapies, estimating a market size of $4 billion to $5 billion for both Merck and AstraZeneca, which NewAmsterdam aims to capture with its innovative approach [15][16]. - **Patient Compliance Concerns**: The discussion highlighted the challenges of patient compliance in real-world settings compared to clinical trials, which may affect the uptake of new therapies [13][14]. - **Emerging Technologies**: The future of lipid management is expected to be transformed by new technologies and therapies, including gene editing approaches, which could significantly impact cardiovascular disease prevention [54]. Conclusion NewAmsterdam Pharma is positioned to capitalize on the evolving landscape of lipid management with its upcoming product, Obsettra. The company is focused on leveraging new evidence supporting aggressive LDL lowering, maintaining a strategic approach to regulatory submissions, and preparing for a competitive market environment. The insights from the AHA meeting and ongoing studies will play a crucial role in shaping the company's future trajectory in the healthcare sector.

Summary of NewAmsterdam Pharma Company (NAMS) 2025 Update Company Overview - **Company**: NewAmsterdam Pharma Company (NAMS) - **Event**: R&D Day held on June 11, 2025 - **Focus**: Updates on Alzheimer's research and drug development, particularly obacetropib Key Points Discussed 1. Corporate and Clinical Updates - 2024 was a successful year with the completion of three Phase III trials: Brooklyn, Tandem, and Broadway [5] - The company has expanded its commercial team to nearly 100 people across the U.S. and Amsterdam [5] - New Composition of Matter IP secured exclusivity until February 1943 [6] - Data from Broadway and Tandem trials published in reputable journals, enhancing credibility [6] 2. Alzheimer's Disease Research - The company is focusing on HDL raising as a potential treatment pathway for Alzheimer's disease [9] - Obacetropib is being studied for its LDL lowering effects, which may also benefit Alzheimer's patients [10] - The brain's cholesterol metabolism is distinct, with HDL being crucial for brain health [11][12] - The company is exploring the relationship between HDL levels and amyloid beta plaque formation, which is linked to Alzheimer's [13][14] 3. APOE4 Gene and Alzheimer's Risk - APOE4 carriers have a significantly increased risk of cardiovascular disease and Alzheimer's [15] - The company aims to determine if obacetropib can effectively prevent Alzheimer's in APOE4 patients [16] - The urgency for treatment is heightened in APOE4 patients due to their family history of Alzheimer's [28] 4. Clinical Trial Insights - The Broadway trial included 3,000 patients and showed promising results in reducing Alzheimer's biomarkers [22] - The pTal217 biomarker is highlighted as a significant predictor for Alzheimer's progression [20] - The company plans to present further data at the AIC conference on July 30 [7] 5. Drug Mechanism and Benefits - Obacetropib targets the CETP protein, inhibiting its activity by 97%, which may influence both heart and brain health [44] - The drug has shown a reduction in small LDL particles, which are more harmful to arterial health [73] - The reduction in small particles is believed to contribute to the observed MACE (major adverse cardiovascular events) reduction in trials [78] 6. Future Directions - The PREVAIL study is ongoing, designed to evaluate the long-term benefits of obacetropib [35] - The company is considering expanding the MACE endpoint to include ischemic stroke and other cardiovascular events [43] - There is a focus on the potential of obacetropib to replace existing therapies like PCSK9 inhibitors due to its broader benefits [31] 7. Market Positioning - Obacetropib is positioned as a complementary therapy to statins, addressing limitations such as increased Lp(a) levels and diabetes risk associated with statins [29][30] - The company is optimistic about the drug's market potential, especially among high-risk populations [32] Additional Important Insights - The company has received positive feedback from the medical community regarding the efficacy and safety profile of obacetropib [30] - The integration of new biomarkers into patient care is expected to enhance diagnosis and treatment monitoring for Alzheimer's [21] - The company emphasizes the importance of understanding lipid metabolism in developing effective therapies for both cardiovascular and neurodegenerative diseases [63][64] This summary encapsulates the critical updates and insights shared during the NewAmsterdam Pharma Company R&D Day, highlighting the company's strategic focus on Alzheimer's research and the development of obacetropib as a potential therapeutic option.

Summary of NewAmsterdam Pharma Company (NAMS) FY Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NAMS) - **Focus**: Development of LDL lowering therapies, specifically elbocetropib Market Opportunity - The LDL lowering market has evolved significantly over the past 15 years, with guidelines shifting to recommend lower LDL targets for high-risk patients, specifically a target of 55 mg/dL [2][5] - The market for LDL lowering drugs is growing, with branded drugs like Repatha increasing by 40% and generic Ezetimibe by 20% [5] - Elbocetropib is positioned to lower LDL by 35% to 50%, making it a competitive option in the market [17] Product Differentiation - Elbocetropib is an LDL plus drug, offering additional benefits beyond LDL lowering, such as potential diabetes protection and Alzheimer's disease implications [6][14] - The drug is well tolerated, with adverse events comparable to placebo, making it appealing for primary care prescriptions [17] - Elbocetropib targets a patient population that does not qualify for injectable therapies, addressing a significant unmet need [18][19] Clinical Trials and FDA Interaction - NAMS has conducted three phase three trials (Brooklyn, Broadway, and Tandem) demonstrating significant LDL lowering efficacy [25][26] - The FDA has requested a dedicated blood pressure trial and an outcome study during the review period, which is expected to read out by the end of 2026 [27][28] - The Broadway trial showed a 21% MACE benefit, indicating potential cardiovascular advantages [29] Financial Position - NAMS has over $800 million in cash, providing a strong financial position for upcoming launches and trials [39][40] - The company is preparing for a structured commercial rollout, with a focus on timing regulatory filings and launch strategies [42] Partnerships and Market Strategy - NAMS has a partnership with Metarini in Europe, which provided significant upfront payments to support the company’s financial needs [43][44] - The company is exploring options for a potential partnership in the U.S. but is currently focused on a go-alone strategy to maximize shareholder value [46] Regulatory Environment - The company is monitoring drug pricing policy dynamics, particularly in relation to its European partner, which may provide some advantages regarding pricing control [49][50] Upcoming Catalysts - Key upcoming events include an R&D Day where further data on MACE benefits and atherosclerosis will be presented, as well as a presentation at the AIC meeting on July 30 [51][53] - The company plans to file for approval in Europe in the second half of the year and is working on a study combining elbocetropib with PCSK9 inhibitors [57] Conclusion - NewAmsterdam Pharma is positioned to capitalize on the growing LDL lowering market with its innovative product, elbocetropib, which offers unique benefits and a strong clinical profile. The company is well-financed and strategically planning for future growth and regulatory approvals.

Summary of Esperion Therapeutics (ESPR) Conference Call Company Overview - **Company**: Esperion Therapeutics (ESPR) - **Product**: Bempedoic acid (Nexlazet and Nexlitol) - **Market Position**: Focused on LDL lowering therapies, particularly in primary and secondary prevention of cardiovascular diseases Key Points Industry and Market Dynamics - **Market Expansion**: The new label for bempedoic acid expanded the total addressable market (TAM) from 10 million to 70 million patients, including both secondary and primary prevention indications [5][24] - **Growth Trajectory**: The company reported high single-digit growth in 2021, transitioning to high double-digit growth post-label approval in 2023 [5][19] - **Sales Potential**: Peak sales potential for bempedoic acid is projected to exceed $1 billion [5] Prescription Trends - **Adoption by Physicians**: There is an increasing adoption of bempedoic acid among primary care physicians, with a notable rise in new prescribers [7][8] - **Statin Intolerance**: The drug is being positioned as a solution for patients who cannot tolerate statins, which accounts for up to 30% of patients needing LDL lowering [8][10] Coverage and Access - **Insurance Coverage**: The company has achieved 92% coverage in commercial plans and 72% in Medicare, with significant improvements in approval rates due to the introduction of field reimbursement managers [10][12] - **Removal of Barriers**: The new label has eliminated previous step edits and prior authorization requirements for certain plans, facilitating easier access for patients [10][11] Financial Outlook - **Revenue Growth**: The company anticipates a return to double-digit growth in revenue, with expectations of profitability by Q1 2026, potentially earlier due to milestone payments from Otsuka [19][20] - **Sales Projections**: Consensus estimates for bempedoic acid sales are in the range of $165 million to $170 million for the current year [21] Competitive Landscape - **Future Competition**: The company does not expect significant competition in the LDL lowering space until 2028, allowing for continued market share growth [24][25] - **New Drug Developments**: The CEO expressed cautious optimism regarding new entrants in the market, emphasizing the need for robust clinical data to support efficacy claims [26][30] Intellectual Property and Litigation - **Patent Settlements**: Two out of nine ANDA filers have settled, extending exclusivity until April 2040, with ongoing confidence in the strength of manufacturing patents [34][36] - **Future IP Strategy**: The company is exploring additional extensions of exclusivity through potential partnerships and product combinations [42] Business Development Strategy - **Partnership Opportunities**: Esperion is actively seeking partnerships in the cardiometabolic space, leveraging its existing infrastructure to support the launch of new drugs without significant cash outlay [48][54] - **Focus Areas**: The company is looking at both public and private companies for potential collaborations, particularly in areas with high overlap in call points [56][61] Pipeline Developments - **Research and Development**: The company is advancing its internal pipeline, particularly in primary sclerosing cholangitis and kidney programs, with plans for updates in the near future [62][65] - **External Interest**: There is growing interest from other companies in Esperion's pipeline, indicating potential for future partnerships [68] Conclusion Esperion Therapeutics is positioned for significant growth in the LDL lowering market, driven by the successful launch of bempedoic acid and strategic initiatives to enhance access and adoption among healthcare providers. The company is also exploring partnerships to expand its product offerings while maintaining a strong focus on its internal pipeline developments.