Summary of NewAmsterdam Pharma Conference Call Company Overview - **Company**: NewAmsterdam Pharma (NasdaqGM: NAMS) - **Key Molecule**: Obicetrapib - **Conference Date**: November 19, 2025 Core Industry Insights - **Clinical Trials**: NewAmsterdam has successfully completed three phase 3 trials, which bolster confidence in the upcoming EMA application for obicetrapib approval in 2026 [4][6] - **Market Positioning**: The company aims to establish a global brand for obicetrapib, emphasizing its benefits beyond just LDL reduction, including increasing HDL and reducing small particle LDL [5][6] Key Points on Obicetrapib - **Clinical Efficacy**: A previous phase 3 trial (Broadway) demonstrated a 21% reduction in major adverse cardiovascular events (MACE), which is expected to translate positively in the PREVAIL trial [8][10] - **Trial Design**: The PREVAIL trial is designed to avoid past mistakes, being longer and targeting high-risk patients, which enhances confidence in its outcomes [8][10] - **Regulatory Strategy**: NewAmsterdam plans to have outcomes data available at the time of launch, a unique position in the lipid-lowering space [16][17] Competitive Landscape - **Comparison with PCSK9 Inhibitors**: NewAmsterdam's obicetrapib is positioned against oral PCSK9 inhibitors, with the expectation that oral administration will increase patient adherence compared to injections [40][41] - **Market Expansion**: The company believes that the market for lipid-lowering drugs is expanding, with a significant number of patients not currently at treatment goals [43] Additional Insights - **Alzheimer's Disease**: There is potential for obicetrapib to impact Alzheimer's disease biomarkers, indicating a broader therapeutic profile compared to traditional statins [25][41] - **Patient Population**: The target population for obicetrapib includes a large number of patients with diabetes or prediabetes, which is a significant market opportunity [41][43] - **Clinical Goals**: The focus is on achieving treatment goals rather than just numerical reductions in LDL, with a reported goal attainment of 70-80% in clinical trials [30][41] Conclusion - NewAmsterdam Pharma is strategically positioned with obicetrapib, focusing on comprehensive cardiovascular benefits and a robust regulatory strategy, while navigating a competitive landscape that includes oral PCSK9 inhibitors. The company is optimistic about its upcoming trials and market potential, particularly in addressing unmet needs in lipid management and related comorbidities.

Core Insights - The article discusses the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2]. Group 1: Service Offerings - Biotech Analysis Central offers a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and live chat features for investors [2]. - The service is priced at $49 per month, with a yearly plan available at a discounted rate of $399, representing a 33.50% discount [1]. Group 2: Analyst Background - The author, Terry Chrisomalis, is a private investor with a background in Applied Science, focusing on generating long-term value in the healthcare sector [2]. - The service aims to assist healthcare investors in making informed decisions through comprehensive analysis and news reports [2].

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.

Core Insights - NewAmsterdam Pharma Company N.V. reported a quarterly loss of $0.41 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.38, and a significant increase from a loss of $0.18 per share a year ago [1] - The company's revenues for the quarter ended September 2025 were $0.35 million, missing the Zacks Consensus Estimate by 91.03%, and a sharp decline from $29.11 million in the same quarter last year [2] - The stock has increased approximately 42.1% since the beginning of the year, outperforming the S&P 500's gain of 15.1% [3] Earnings Outlook - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the next quarter is -$0.40 on revenues of $9.96 million, and for the current fiscal year, it is -$1.30 on revenues of $27.64 million [7] Industry Context - The Medical - Drugs industry, to which NewAmsterdam Pharma belongs, is currently ranked in the top 40% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors or through tools like the Zacks Rank [5][6]

Revenue and Financial Performance - The company has not generated significant revenue from pharmaceutical product sales, primarily relying on a non-refundable upfront amount of $120.9 million (€115.0 million) from the Menarini License[78]. - Revenue for the three months ended September 30, 2025 was $0.3 million, a decrease of $28.8 million or 99% compared to $29.1 million for the same period in 2024, primarily due to the absence of clinical milestones earned in 2025[94]. - For the nine months ended September 30, 2025, revenue was $22.5 million, a decrease of $10.3 million or 31% compared to $32.8 million for the same period in 2024[106]. - The company recognizes revenue from the sale of obicetrapib tablets and active pharmaceutical ingredients, with revenue recognized upon the transfer of control to Menarini[82]. - The December 2024 Offering generated net proceeds of $453.4 million after deducting underwriting discounts and commissions, enhancing the company's capital resources[118]. - The company completed a public offering of 5,871,909 Ordinary Shares at a price of $19.00 per share, generating net proceeds of $190.0 million after expenses[119]. - The company entered into a sales agreement allowing for the issuance of up to $250 million of Ordinary Shares, with no sales made under this agreement during the nine months ended September 30, 2025[120]. Expenses and Losses - Research and development expenses are expected to be significant as the company advances product candidates through clinical trials and pursues regulatory approval[86]. - Research and development expenses decreased by $4.7 million or 13% to $31.0 million for the three months ended September 30, 2025, driven by a $6.6 million decrease in clinical expenses due to the completion of several Phase 3 trials[95][97]. - Selling, general and administrative expenses increased by $6.1 million or 33% to $24.5 million for the three months ended September 30, 2025, primarily due to a $6.3 million increase in personnel expenses[98]. - Loss for the period was $72.0 million for the three months ended September 30, 2025, an increase of $55.4 million compared to a loss of $16.6 million for the same period in 2024[103]. - Total operating expenses for the nine months ended September 30, 2025 were $182.2 million, an increase of $16.3 million compared to $165.9 million for the same period in 2024[105]. - The company incurred an accumulated loss of $687.5 million as of September 30, 2025, and expects to continue incurring significant losses in the foreseeable future[116]. Cash and Liquidity - Cash, cash equivalents, and marketable securities as of September 30, 2025 totaled $756.0 million, providing liquidity for ongoing operations[117]. - The company had cash and cash equivalents of $538.4 million as of September 30, 2025, sufficient to meet estimated obligations of $27.9 million due within one year[130]. - Net cash used in operating activities decreased to $106.9 million for the nine months ended September 30, 2025, from $121.1 million in the same period of 2024[126]. - Net cash used in investing activities increased significantly to $153.8 million in the nine months ended September 30, 2025, primarily due to investments in marketable securities[128]. - Net cash provided by financing activities decreased to $15.8 million for the nine months ended September 30, 2025, compared to $202.9 million in the same period of 2024[129]. Clinical Trials and Product Development - The Phase 3 BROADWAY trial showed a 21% reduction in major adverse cardiovascular events (MACE) endpoint, with ongoing Phase 3 cardiovascular outcomes trial (PREVAIL) expected to conclude by the end of 2026[68]. - Obicetrapib demonstrated statistically significant LDL-C reductions in multiple Phase 3 trials, meeting primary and secondary endpoints[67]. - Approximately 30 million patients in the U.S. do not achieve risk-based LDL-C goals despite lipid-lowering therapy, highlighting a significant market opportunity[72]. - The company aims to develop an LDL-C lowering monotherapy and a fixed-dose combination therapy to address unmet needs in patients with elevated LDL-C[73]. - The company has observed obicetrapib to be well tolerated in over 3,500 patients, with side effects similar in frequency and severity to placebo[67]. Partnerships and Agreements - The company has partnered with Menarini for the commercialization of obicetrapib in Europe, with marketing authorization applications validated by the European Medicines Agency[75]. - The Menarini Supply Agreement includes provisions for the transfer of manufacturing and establishes the company as Menarini's exclusive supplier of obicetrapib products[76]. - Under the Menarini License, the company received a non-refundable upfront payment of €115 million and is eligible for up to €863 million in milestone payments[121][122]. - As of September 30, 2025, the company received €30.0 million in milestone payments and €13.8 million in R&D reimbursements from Menarini[123]. Financial Instruments and Risks - The fair value of derivative warrant liabilities was $44.4 million as of September 30, 2025, with a 1% change in market price affecting the liability by $0.4 million[141]. - The company's exposure to foreign currency risk was $112.8 million as of September 30, 2025, with a potential earnings impact of approximately $1.1 million from a hypothetical 1% change in exchange rates[139].

Financial Performance - Revenue for the quarter ended September 30, 2025, was $0.3 million, a significant decrease from $29.1 million in the same period in 2024, mainly due to the absence of clinical milestone revenue[8] - Revenue for Q3 2025 was $348,000, a significant decrease from $29,111,000 in Q3 2024, representing a decline of approximately 98.8%[23] - The net loss for the quarter ended September 30, 2025, was $72.0 million, compared to a net loss of $16.6 million for the same period in 2024[9] - The operating loss for Q3 2025 was $55,143,000, compared to an operating loss of $25,003,000 in Q3 2024, reflecting a deterioration of 120.5%[23] - The company reported a loss for the nine months ended September 30, 2025, of $128,896,000, an improvement compared to a loss of $149,421,000 for the same period in 2024, showing a reduction of approximately 13.7%[26] Cash and Assets - As of September 30, 2025, NewAmsterdam reported cash, cash equivalents, and marketable securities of $756.0 million, down from $834.2 million as of December 31, 2024, primarily due to ongoing operating expenditures[8] - Cash and cash equivalents as of September 30, 2025, were $538,407,000, down from $771,743,000 at the end of 2024, a decrease of approximately 30.1%[21] - Total assets decreased to $786,427,000 as of September 30, 2025, from $864,620,000 at the end of 2024, a decline of about 9.0%[21] - The company had a total shareholders' equity of $728,070,000 as of September 30, 2025, compared to $757,500,000 at the end of 2024, a decrease of approximately 3.9%[21] Expenses - Research and Development (R&D) expenses were $31.0 million for the quarter ended September 30, 2025, compared to $35.7 million for the same period in 2024, reflecting a decrease in clinical and manufacturing expenses[8] - Selling, General and Administrative (SG&A) expenses increased to $24.5 million in the quarter ended September 30, 2025, from $18.4 million in the same period in 2024, driven by higher personnel costs[8] - Total operating expenses for Q3 2025 were $55,491,000, slightly up from $54,114,000 in Q3 2024, indicating an increase of about 2.5%[23] - Research and development expenses for Q3 2025 were $30,971,000, down from $35,702,000 in Q3 2024, a decrease of about 13.5%[23] Clinical Development - The European Medicines Agency accepted for review marketing authorization applications for obicetrapib monotherapy and the fixed-dose combination with ezetimibe in August 2025, marking a significant regulatory milestone[5] - NewAmsterdam plans to initiate the RUBENS Phase 3 clinical trial in Q4 2025 to evaluate obicetrapib in combination with ezetimibe for patients with type 2 diabetes or metabolic syndrome[4] - In the BROADWAY trial, obicetrapib was shown to reduce p-tau217 levels by 20.5% over 12 months in ApoE4/E4 carriers, indicating potential benefits for Alzheimer's disease[3] - The company completed enrollment of over 9,500 patients in the PREVAIL Phase 3 cardiovascular outcomes trial in April 2024[7] - NewAmsterdam continues to advance its clinical development strategy, including ongoing trials such as PREVAIL and REMBRANDT, to support the potential launch of obicetrapib[2] Interest Income - Interest income for the nine months ended September 30, 2025, was $21,119,000, an increase from $12,396,000 in the same period of 2024, representing a growth of about 70.5%[23] Cash Flow - The company experienced a net cash used in operating activities of $106,908,000 for the nine months ended September 30, 2025, compared to $121,083,000 for the same period in 2024, indicating a decrease of approximately 11.7%[26]

Core Insights - NewAmsterdam Pharma is focused on advancing obicetrapib, a novel oral therapy for lowering LDL-C in patients at risk of cardiovascular disease, with recent regulatory milestones achieved in Europe [2][7][11] Clinical Development Updates - The European Medicines Agency has accepted marketing authorization applications for obicetrapib and its fixed-dose combination with ezetimibe, marking a significant regulatory milestone [2][7] - Ongoing clinical trials include PREVAIL, a cardiovascular outcomes trial with over 9,500 patients enrolled, and REMBRANDT, a Phase 3 imaging trial [9][11] - Recent data from the BROADWAY trial indicates obicetrapib's potential to modify Alzheimer's disease biomarkers, particularly in high-risk patients [5][13] Financial Performance - As of September 30, 2025, NewAmsterdam reported cash, cash equivalents, and marketable securities totaling $756.0 million, a decrease from $834.2 million at the end of 2024 [10][21] - Revenue for the third quarter of 2025 was $0.3 million, down from $29.1 million in the same period in 2024, primarily due to the absence of clinical milestone revenue [10][23] - Research and development expenses decreased to $31.0 million from $35.7 million year-over-year, while selling, general, and administrative expenses increased to $24.5 million from $18.4 million [10][23] Market Context - Cardiovascular disease remains a leading cause of death globally, with a significant unmet need for effective LDL-C lowering therapies, as many patients do not achieve their LDL-C goals despite existing treatments [12][14] - The company aims to address this gap with obicetrapib, which has shown promising results in clinical trials, indicating its potential as a differentiated therapy in a growing market [2][11]

Core Insights - NewAmsterdam Pharma is set to present additional safety and efficacy data from pivotal Phase 3 trials at the 2025 AHA Scientific Sessions, highlighting its focus on oral, non-statin medicines for cardiovascular disease patients [1][4] Group 1: Upcoming Presentations - The company will present a pooled analysis of the BROOKLYN and BROADWAY Phase 3 clinical trials, focusing on the effects of CETP inhibition with obicetrapib on LDL particles [2] - A digital poster presentation will discuss the combination of obicetrapib with ezetimibe on atorvastatin and its effects on atherosclerotic plaque lesions in specific mouse models [2] Group 2: Investor Conferences - NewAmsterdam management will participate in several investor conferences, including a fireside chat at the Guggenheim Annual Healthcare Innovation Conference on November 11, 2025 [3] - Additional fireside chats are scheduled at the Stifel Healthcare Conference on November 12, 2025, and the Jefferies London Healthcare Conference on November 19, 2025 [3] Group 3: Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing therapies for metabolic diseases, particularly targeting LDL-C levels in patients at risk of cardiovascular disease [4] - The company is investigating obicetrapib, a low-dose CETP inhibitor, as a potential adjunct therapy to statins for patients who do not respond well to existing treatments [4]

Core Insights - Wall Street anticipates a year-over-year decline in earnings for NewAmsterdam Pharma Company N.V. (NAMS) due to lower revenues, with a consensus expectation of a quarterly loss of $0.38 per share, reflecting a -111.1% change from the previous year [1][3] - Revenues are projected to be $3.88 million, which is an 86.7% decrease compared to the same quarter last year [3] - The stock's price movement will largely depend on how actual results compare to these estimates, with a potential for upward movement if results exceed expectations [2] Earnings Estimates and Revisions - The consensus EPS estimate has been revised down by 6.95% over the last 30 days, indicating a reassessment by analysts [4] - The Most Accurate Estimate for NewAmsterdam Pharma is higher than the Zacks Consensus Estimate, resulting in a positive Earnings ESP of +19.13%, suggesting a likelihood of beating the consensus EPS estimate [12] Earnings Surprise History - In the last reported quarter, NewAmsterdam Pharma was expected to post a loss of $0.52 per share but actually reported a loss of -$0.15, resulting in a positive surprise of +71.15% [13] - Over the past four quarters, the company has beaten consensus EPS estimates two times [14] Industry Context - In the Zacks Medical - Drugs industry, Corcept Therapeutics is expected to report earnings of $0.18 per share, indicating a year-over-year decline of -56.1%, with revenues expected to be $219.18 million, up 20.1% from the previous year [19] - Corcept's consensus EPS estimate has been revised down by 9.7% over the last 30 days, and it has a negative Earnings ESP of -72.60%, combined with a Zacks Rank of 5 (Strong Sell), making it challenging to predict an earnings beat [20]