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 ...

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].

NewAmsterdam Pharma Provides Corporate Update and Reports First Quarter Financial Results – EMA submission expected in 2H25 by partner Menarini – – PREVAIL Phase 3 CVOT remains on track – -- BROADWAY and TANDEM results presented at EAS with simultaneous publications in the New England Journal of Medicine and The Lancet, respectively -- -- Company to host R&D day on June 11 th , 2025 in New York City -- –$808.5 million in cash, cash equivalents and marketable securities at March 31, 2025 – Naarden, the Nethe ...

Core Insights - NewAmsterdam Pharma is advancing its clinical development of obicetrapib, an oral, low-dose CETP inhibitor aimed at lowering LDL-C in patients at risk of cardiovascular disease (CVD) [4][14] - The company reported a cash position of $808.5 million as of March 31, 2025, indicating strong financial backing for ongoing and future projects [11][3] - NewAmsterdam plans to submit for EMA approval in the second half of 2025 through its partner Menarini, highlighting its regulatory progress [3][4] Financial Performance - For the first quarter of 2025, NewAmsterdam recognized $3.0 million in revenue, up from $1.4 million in the same period in 2024, primarily due to increased transaction prices related to R&D contributions from Menarini [11] - Research and Development (R&D) expenses increased to $44.8 million in Q1 2025 from $42.4 million in Q1 2024, driven by higher personnel costs and investments in pipeline expansion [11] - Selling, General and Administrative (SG&A) expenses rose significantly to $27.2 million in Q1 2025 from $14.5 million in Q1 2024, reflecting increased costs associated with the planned commercial launch of obicetrapib [11] Clinical Development Updates - NewAmsterdam is conducting several pivotal Phase 3 trials, including PREVAIL, which has enrolled over 9,500 patients to evaluate obicetrapib's impact on major adverse cardiac events (MACE) [5][10] - The company is also progressing with the VINCENT Phase 2 trial, assessing the effects of obicetrapib alone and in combination with evolocumab on lipoprotein (a) [5] - The REMBRANDT Phase 3 trial will evaluate the effect of obicetrapib plus ezetimibe on coronary plaque in high-risk ASCVD patients [6] Corporate Updates - NewAmsterdam appointed Adele Gulfo to its Board of Directors in April 2025, bringing over three decades of pharmaceutical experience [7] - The company will host an R&D Day on June 11, 2025, to discuss its research and development initiatives [8] 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 with current treatments [13][14] - The company aims to address the needs of the approximately 30 million under-treated U.S. adults who are not at their risk-based LDL-C goal [13]

Core Insights - NewAmsterdam Pharma has presented compelling clinical data from the BROADWAY and TANDEM Phase 3 trials, demonstrating significant reductions in LDL-C and Lp(a) levels, which are critical for patients at risk of cardiovascular disease [1][2][6] Company Overview - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medications for patients with elevated LDL-C who are at risk of cardiovascular disease [1][13] - The company is investigating obicetrapib, a low-dose CETP inhibitor, as a potential adjunct therapy to statins for improving LDL-C levels [8][13] Clinical Trial Findings - The BROADWAY trial showed that obicetrapib reduced LDL-C by 50% when used with statins and by 35% as monotherapy, with a notable 21% reduction in major adverse cardiovascular events [4][5] - The TANDEM trial demonstrated that the fixed-dose combination of obicetrapib and ezetimibe achieved a statistically significant LDL-C reduction of 48.6% compared to placebo [3][4] - Pooled data from the BROADWAY, TANDEM, and BROOKLYN trials indicated a median placebo-adjusted reduction of 45% in Lp(a) levels after 12 weeks of treatment [6][7] Market Context - Cardiovascular disease remains the leading cause of death globally, with a significant number of patients unable to reach their LDL-C goals despite the availability of lipid-lowering therapies [9][12] - Approximately 30 million under-treated adults in the U.S. are not at their risk-based LDL-C goal, highlighting a substantial clinical need for effective therapies [12] Future Prospects - The data presented at EAS 2025 is expected to support global regulatory filings for obicetrapib, reinforcing its potential as a foundational therapy in cardiovascular disease management [2][7] - The company has completed enrollment for the Phase 3 PREVAIL trial, which aims to assess the impact of obicetrapib on major adverse cardiovascular events [8]

Core Insights - NewAmsterdam Pharma is presenting new clinical and preclinical data on obicetrapib, an oral, low-dose therapy for hypercholesterolemia, at the European Atherosclerosis Society Congress in May 2025 [1] - The company aims to address the unmet need for effective LDL-C lowering therapies for patients at risk of cardiovascular disease [4] Clinical Trial Presentations - A Phase 3 randomized trial on the fixed-dose combination of obicetrapib and ezetimibe for LDL-C reduction will be presented on May 5, 2025 [2] - Safety and efficacy data of obicetrapib in high cardiovascular risk patients will also be discussed on the same day [2] Additional Session Details - Obicetrapib's effects on atherosclerosis and vascular inflammation will be presented, highlighting its role in reducing non-HDL cholesterol and improving lesion stability [3] - The therapy's impact on reverse cholesterol transport and its safety in combination with moderate-dose statins will be showcased in various sessions [3] Company Overview - NewAmsterdam Pharma focuses on developing oral, non-statin medicines for patients with elevated LDL-C, aiming to improve patient care in populations with metabolic diseases [4] - The company is conducting multiple Phase 3 trials to investigate obicetrapib as a CETP inhibitor, both alone and in combination with ezetimibe [4]

Core Insights - NewAmsterdam Pharma has appointed Adele Gulfo as an independent director to its Board of Directors, bringing over 30 years of experience in the healthcare industry [1][2][4] - The company is preparing for the potential launch of obicetrapib, an oral, non-statin medicine aimed at lowering LDL-C for patients at risk of cardiovascular disease [2][5] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing therapies for cardiometabolic diseases, specifically targeting patients with elevated LDL-C who do not respond well to existing treatments [5] - The company is investigating obicetrapib as a cholesterol ester transfer protein (CETP) inhibitor, which is being tested in multiple Phase 3 trials [5] Leadership and Experience - Adele Gulfo has a strong background in commercial leadership, having previously held executive roles at Sumitomo Pharma America, Sumitovant Biopharma, and Pfizer, where she contributed to the launch of major brands like LIPITOR® and CRESTOR® [2][3] - Her expertise in global strategy and operations is expected to be crucial for NewAmsterdam as it finalizes its commercial strategy and prepares for its first product launch [2][4] Clinical Development - NewAmsterdam has reported positive outcomes from its three pivotal Phase 3 clinical trials, indicating progress in its development efforts [4]

NAARDEN, the Netherlands and MIAMI, March 31, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or "NewAmsterdam" or the "Company"), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease ("CVD") with elevated low-density lipoprotein cholesterol ("LDL-C"), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that Ian Somaiya, Chief Financial Officer of NewAmsterdam Ph ...

Company Overview - NewAmsterdam Pharma (NASDAQ: NAMS) is a biotech company focused on developing obicetrapib, a second-generation CETP inhibitor aimed at addressing cardiovascular risk indications [1] Investment Focus - The company targets growth markets, particularly in biotech, and seeks undervalued stocks with significant potential [1] - The investment strategy includes a diverse portfolio ranging from megacap to microcap stocks, primarily in the U.S. market, with occasional interest in European or Canadian stocks [1] Market Position - Obicetrapib is positioned as a potentially best-in-class treatment, indicating a strong competitive edge in the biotech sector [1]

Group 1 - NewAmsterdam Pharma Company N.V. (NASDAQ: NAMS) has a strong late-stage cardiovascular pipeline in the biotech sector, which remains relatively unnoticed in the market [1] - The current market focus is primarily on GLP-1s and their potential impacts, indicating a competitive landscape in the biotech industry [1] - The company is positioned in a high-growth sector that is expected to experience exponential expansion, highlighting its potential for substantial returns through innovation [1]