NewAmsterdam Pharma pany N.V.(NAMS)

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NewAmsterdam Pharma Company (NAMS) FY Conference Transcript
2025-06-09 19:42
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.
NewAmsterdam Pharma Announces Positive Topline Alzheimer's Disease Data from BROADWAY Clinical Trial
Globenewswire· 2025-06-09 11:00
-- Pre-specified analyses show that obicetrapib treatment leads to statistically significant and clinically meaningful reductions in the primary outcome measure of Alzheimer's disease biomarker in both the full ITT population (p<0.002) and in ApoE4 carriers (p=0.0215), supporting the emerging link between CETP-inhibition and prevention of AD pathology -- -- NewAmsterdam to present results during the AAIC conference in July -- NAARDEN, The Netherlands and MIAMI, June 09, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam ...
NewAmsterdam Pharma to Host R&D Day on June 11, 2025
GlobeNewswire News Room· 2025-06-05 12:00
Company Overview - NewAmsterdam Pharma Company N.V. is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C) [1][5] - The company aims to address the unmet need for safe, well-tolerated, and convenient LDL-lowering therapies, particularly for patients who do not respond adequately to existing treatments [5] R&D Day Announcement - NewAmsterdam will host an R&D Day event for analysts and investors on June 11, 2025, at 9:00 a.m. ET in New York City [1] - The event will feature key members of the management team, including the CEO and Chief Scientific Officer [2] Obicetrapib Development - Obicetrapib is a novel, oral, low-dose CETP inhibitor being developed by NewAmsterdam to improve LDL-lowering treatment outcomes [4] - The company has conducted multiple Phase 2 and Phase 3 trials, demonstrating statistically significant LDL-lowering effects with a side effect profile similar to placebo [4] - The Phase 3 PREVAIL CVOT trial, which commenced in March 2022, has enrolled over 9,500 patients to assess obicetrapib's potential in reducing major adverse cardiovascular events (MACE) [4] Commercialization Rights - The commercialization rights for obicetrapib in Europe have been exclusively granted to the Menarini Group, a leading international pharmaceutical and diagnostics company [4]
NewAmsterdam Pharma Company (NAMS) 2025 Conference Transcript
2025-06-04 15:30
Summary of NewAmsterdam Pharma Company (NAMS) Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NAMS) - **Event**: Jefferies Healthcare Conference - **Date**: June 04, 2025 Key Points Industry and Market Context - The focus is on redefining the treatment of Atherosclerotic Cardiovascular Disease (ASCVD) beyond just LDL reduction to include other risk factors such as LpLA and diabetes [3][6][24] - There are approximately **70 million patients in the U.S.** with elevated LDL under treatment, indicating a vast market opportunity for NAMS's drug, obisetropib [10] Drug Development and Clinical Trials - NAMS has had **three positive Phase III trial readouts** last year, boosting confidence in regulatory approval and market entry [3] - The company is targeting additional conferences to present data that differentiates obisetropib from existing and developing drugs [4] - Obisetropib has shown an **average of 45% reduction in LpLA** in Phase III studies, addressing a significant patient population that does not qualify for existing LpLA-targeted therapies [13] Competitive Advantages - Obisetropib aims to address multiple cardiometabolic risk factors, including LDL, LpLA, and diabetes, making it a comprehensive treatment option [6][29] - The drug is positioned to potentially outperform existing therapies by significantly reducing small LDL particles, which are not effectively targeted by current treatments [37][38] Regulatory and Commercial Strategy - NAMS plans to engage with regulatory agencies to include LpLA in clinical trial sections, which could enhance the drug's marketability [15][16] - The company has raised approximately **$700 million** in financing, providing a strong balance sheet of about **$810 million** to support clinical trials and a planned U.S. launch around **2027** [52][53][54] Future Outlook - The ASCVD market is expected to evolve towards combination therapies and fixed-dose approaches, with obisetropib positioned as a preferred option due to its comprehensive risk factor management [24][28] - The company anticipates a **21% MACE benefit** based on recent data, which could significantly enhance its competitive position in the market [34][49] Additional Insights - NAMS is conducting a Phase II trial (Vinson study) to evaluate the combination of obisetropib with Amgen's Repatha, focusing on both LDL and LpLA reduction [14][19] - The company emphasizes the importance of safety and convenience in treatment options, aiming to provide a low-dose, once-daily pill for patients [32] Conclusion NewAmsterdam Pharma is strategically positioned to redefine ASCVD treatment with obisetropib, leveraging positive clinical trial results and a robust financial foundation to capture a significant share of the market. The focus on comprehensive risk factor management and engagement with regulatory bodies will be crucial for its future success.
NewAmsterdam Pharma Company (NAMS) FY Conference Transcript
2025-06-03 21:20
Summary of NewAmsterdam Pharma Company (NAMS) FY Conference Company Overview - **Company**: NewAmsterdam Pharma Company (NAMS) - **Focus**: Development of novel LDL lowering therapies, specifically obacetropib, targeting high-risk patients with elevated LDL levels [1][2] Key Industry Insights - **Market Dynamics**: The LDL lowering therapy market is experiencing robust growth, with drugs growing over 40% annually, and even generic ezetimibe growing over 20% per year [7][8] - **Patient Need**: Over 30 million patients are above the LDL target of 55, indicating a significant need for new therapies [5][9] Core Product Insights - **Obacetropib**: - Achieves LDL lowering of 35% to over 50% [5] - Demonstrated a 21% reduction in cardiovascular events in Phase III trials [5][15] - Well tolerated with no significant side effects compared to placebo [21] - Can be combined with ezetimibe to enhance efficacy, achieving over 90% of patients reaching LDL targets [14][15] Clinical Data Highlights - **Phase III Trials**: - Broadway and Brooklyn trials showed significant cardiovascular benefits and LDL lowering efficacy [22][15] - MACE (major adverse cardiac events) benefit observed at 21% reduction within 12 months [15] - Small particle reduction by 90%, which is associated with cardiovascular events [17][18] Safety and Efficacy - **Safety Profile**: - No increase in liver or muscle enzymes, and a decrease in diabetes risk [21] - Extremely safe based on Phase III data, addressing patient concerns about side effects [21] Future Developments - **Ongoing Trials**: - PREVAIL cardiovascular outcome trial fully enrolled, results expected by the end of 2026 [25] - Research into Alzheimer's disease due to HDL raising properties of obacetropib [23][24] - Imaging trial (Rembrandt) for plaque reduction also underway [24] Commercial Strategy - **Market Positioning**: - Plans to leverage patient demand and unique drug profile to navigate insurance coverage challenges [46][47] - Focus on cardiometabolic patients, who represent a significant portion of the target market [50][51] Additional Considerations - **Guideline Changes**: The shift in guidelines in 2013 led to an increase in cardiovascular deaths, highlighting the need for effective LDL lowering therapies [9] - **Patient Education**: Emphasis on educating patients about the benefits of obacetropib, particularly regarding its diabetes risk profile [33][34] Conclusion - NewAmsterdam Pharma is positioned to address a significant unmet need in the LDL lowering therapy market with obacetropib, supported by strong clinical data and a robust safety profile. The company is focused on upcoming trials and commercial strategies to maximize patient access and market penetration [26][52]
NewAmsterdam Pharma to Participate at Upcoming Investor Conferences in June
Globenewswire· 2025-05-27 12:00
Company Overview - NewAmsterdam Pharma Company N.V. is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C) [1][3] - The company aims to address the unmet need for safe, well-tolerated, and convenient LDL-lowering therapies, particularly for patients who do not respond adequately to existing treatments [3] Product Development - NewAmsterdam is conducting multiple phase 3 trials for obicetrapib, an oral, low-dose, once-daily CETP inhibitor, which is being investigated as a standalone treatment and in combination with ezetimibe [3] - The target population includes patients at risk of CVD with elevated LDL-C levels, for whom current therapies are insufficiently effective or poorly tolerated [3] Upcoming Events - The company will participate in several investor conferences: - William Blair 45th Annual Growth Stock Conference in Chicago, IL on June 3, 2025, with a presentation by CEO Michael Davidson at 3:20 p.m. CT [4] - Jefferies Global Healthcare Conference 2025 in New York, NY on June 4, 2025, featuring a fireside chat with CFO Ian Somaiya at 10:30 a.m. ET [4] - Goldman Sachs 46th Annual Healthcare Conference in Miami, FL on June 9, 2025, with participation from CEO Michael Davidson and EVP Matthew Philippe at 2:40 p.m. ET [4] Investor Relations - Live webcasts of the presentations will be available on the investor relations section of the NewAmsterdam Pharma website, with archived replays accessible afterward [2]
NewAmsterdam Pharma to Present at the 2025 RBCCM Global Healthcare Conference
Globenewswire· 2025-05-14 12:00
Matthew Philippe P: 1-917-882-7512 matthew.philippe@newamsterdampharma.com Media Contact Spectrum Science on behalf of NewAmsterdam Jaryd Leady P: 1-856-803-7855 jleady@spectrumscience.com NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lo ...
Wall Street Analysts Predict a 132.5% Upside in NewAmsterdam Pharma Company N.V. (NAMS): Here's What You Should Know
ZACKS· 2025-05-12 15:00
Core Viewpoint - NewAmsterdam Pharma Company N.V. (NAMS) has shown a significant price increase of 21.5% over the past four weeks, with a mean price target of $42.71 indicating a potential upside of 132.5% from the current price of $18.37 [1] Price Targets and Analyst Consensus - The average price target consists of seven estimates ranging from a low of $37 to a high of $52, with a standard deviation of $5.28, suggesting a high degree of agreement among analysts [2] - The lowest estimate indicates a potential increase of 101.4%, while the most optimistic estimate suggests an upside of 183.1% [2] - Analysts' price targets should be approached with caution, as empirical research indicates they often mislead investors rather than provide accurate guidance [7][10] Earnings Estimates and Market Sentiment - Analysts are optimistic about NAMS's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which historically correlates with stock price movements [4][11] - Over the past 30 days, one earnings estimate has increased, leading to a 3.8% rise in the Zacks Consensus Estimate for the current year [12] - NAMS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, further supporting its potential upside [13]
NewAmsterdam Pharma Company N.V. (NAMS) Reports Q1 Loss, Tops Revenue Estimates
ZACKS· 2025-05-08 14:30
NewAmsterdam Pharma Company N.V. (NAMS) came out with a quarterly loss of $0.49 per share versus the Zacks Consensus Estimate of a loss of $0.45. This compares to loss of $0.62 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -8.89%. A quarter ago, it was expected that this company would post a loss of $0.48 per share when it actually produced a loss of $0.95, delivering a surprise of -97.92%.Over the last four quarters, the co ...
NewAmsterdam Pharma pany N.V.(NAMS) - 2025 Q1 - Quarterly Report
2025-05-08 12:00
Financial Position - As of March 31, 2025, the company had cash and cash equivalents of $748.4 million, a decrease from $771.7 million as of December 31, 2024, primarily due to ongoing operating expenditures [79]. - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $808.5 million [105]. - The company had cash and cash equivalents of $748.4 million as of March 31, 2025, which is sufficient to fund its obligations [117]. - The company incurred net cash used in operating activities of $36.468 million for the three months ended March 31, 2025, a decrease of $18.134 million from $54.602 million in 2024 [114]. - The net cash provided by financing activities was $6.519 million for the three months ended March 31, 2025, a decrease of $191.661 million compared to $198.180 million in the prior year [116]. Revenue and Collaborations - The company has not generated any revenue from pharmaceutical product sales, with revenue solely derived from a license agreement with Menarini, which included a non-refundable upfront payment of $120.9 million [81]. - Revenue for the three months ended March 31, 2025, was $2.978 million, an increase of $1.577 million or 113% compared to $1.401 million in the same period of 2024 [96]. - The company does not expect to generate any revenue from product sales for the foreseeable future, with potential future collaborations subject to uncertainties [85]. - The company received a total of €30 million in milestone payments and €13.8 million in R&D cost reimbursements from Menarini as of March 31, 2025 [111]. - The first of two annual installments of €27.5 million from Menarini has been received, contributing to the R&D performance obligation [82]. Research and Development - In the Phase 3 BROADWAY trial, the company observed a 21% reduction in the exploratory major adverse cardiovascular events (MACE) endpoint [72]. - Obicetrapib has shown significant reductions in LDL-C and other biomarkers associated with MACE, with safety comparable to placebo in over 3,500 patients [71]. - The company plans to commercialize obicetrapib for patients with ASCVD and/or heterozygous familial hypercholesterolemia (HeFH) if marketing approval is obtained [77]. - Research and development expenses increased to $44.751 million for the three months ended March 31, 2025, up $2.321 million or 5% from $42.430 million in 2024 [97]. Expenses - Selling, general and administrative expenses are expected to increase due to the growth of the organization and preparation for commercial operations [91]. - Selling, general and administrative expenses rose to $27.152 million, an increase of $12.699 million or 88% compared to $14.453 million in the prior year [98]. Financial Performance - The loss for the period was $39.527 million, a significant improvement of $54.240 million compared to a loss of $93.767 million in the same period of 2024 [103]. - Interest income increased to $7.351 million for the three months ended March 31, 2025, up $4.268 million or 138% from $3.083 million in 2024 [100]. - The fair value change for warrants resulted in a gain of $13.762 million for the three months ended March 31, 2025, compared to a loss of $30.248 million in the same period of 2024 [101]. Risk and Obligations - As of March 31, 2025, the estimated maximum payments due upon cancellation of third-party service agreements are $18.8 million within one year and $1.3 million due in more than a year [117]. - Under the Naarden Lease, the company is obligated to pay €40 thousand per year in rent, while the Miami Lease requires annual rent ranging from $75 thousand to $82 thousand, expiring on October 31, 2027 [118][119]. - The company is responsible for 50% of certain development costs incurred by the other party in the Menarini Territory under the Menarini License agreement [120]. - The company has limited credit risk exposure from treasury activities, holding cash in banks with investment grade credit ratings [131]. Currency Exposure - As of March 31, 2025, the company's net exposure to foreign currency risk was $106.0 million, mainly related to the Euro [128]. - A hypothetical 1% change in exchange rates would result in a potential change in future earnings of approximately $1.1 million [128]. - The fair value of derivative warrant liabilities as of March 31, 2025, totaled $23.5 million, with a 1% change in market price affecting the liability by $0.2 million [130]. Taxation - The company does not yet have any sales but is able to reclaim value added tax from tax authorities, which is believed to be fully recoverable [132].