NAARDEN, The Netherlands and MIAMI, Nov. 25, 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 company management will participate in the following up ...

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 - Esperion Therapeutics (ESPR) is conducting a secondary offering of 30 million shares at $2.50 per share, aiming to raise approximately $75 million in gross proceeds [1][7] - The stock price fell nearly 17% following the announcement due to the discounted pricing, which was 19% below the previous closing price of $3.09 [2][7] - The proceeds from the offering will be used to expand the commercial reach of marketed drugs Nexletol and Nexlizet, support clinical development, and for general corporate purposes [4][7] Financial Details - The secondary offering is expected to close today, with net proceeds estimated at $70.2 million after expenses [1] - The underwriters have an option to purchase an additional 4.5 million shares at the same price [1] Product Information - Nexletol and Nexlizet are marketed for treating elevated LDL-C and cardiovascular risk reduction, with Nexlizet being a combination of bempedoic acid and ezetimibe [5] - The company has settled patent litigation with Dr. Reddy's Laboratories, preventing the launch of generic versions of its drugs until April 19, 2040 [6] Legal Context - Esperion has signed similar agreements with other generic drugmakers, ensuring that they cannot market generics of Nexletol or Nexlizet until 2040 [8] - Ongoing patent litigation remains with other generic challengers, including Sandoz, Aurobindo Pharma, and MSN Pharmaceuticals [8] Market Performance - Year-to-date, ESPR's stock has gained 17%, outperforming the industry average growth of 10% [2]

Core Insights - Esperion has entered into a settlement agreement with Dr. Reddy's Laboratories, resolving patent litigation regarding generic versions of NEXLETOL and NEXLIZET, preventing Dr. Reddy's from marketing these generics in the U.S. before April 19, 2040, unless specific circumstances arise [1] - The settlement with Dr. Reddy's follows previous agreements with Micro Labs USA, Hetero USA, and Accord Healthcare concerning their generic versions of NEXLETOL, ensuring no remaining challenges to the validity of U.S. Patent No. 7,335,799, which expires in December 2030 [2] - Ongoing patent litigation against other defendants remains, with uncertainty regarding the potential for generic versions of NEXLETOL and NEXLIZET to be marketed before the April 2040 date [3] Company Overview - Esperion Therapeutics is a biopharmaceutical company focused on developing and commercializing FDA-approved oral medications for patients at risk for cardiovascular disease, specifically targeting elevated low-density lipoprotein cholesterol (LDL-C) [4] - The company is advancing its pre-clinical pipeline and aims to establish itself as a leading global biopharmaceutical entity through commercial execution and international partnerships [5]

Core Insights - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol [1][3] Company Overview - NewAmsterdam Pharma aims to address unmet needs in metabolic diseases where current therapies are inadequate or poorly tolerated [3] - The company is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, in multiple phase 3 trials [3] - Obicetrapib is being studied as an LDL-C lowering therapy, either alone or in combination with ezetimibe, to be used alongside statin therapy for patients with elevated LDL-C [3] Upcoming Events - John Kastelein and Matthew Philippe will participate in a virtual fireside chat at the Stifel 2025 Virtual Cardiometabolic Forum on September 30, 2025 [1] - A live webcast of the event will be available on the investor relations section of the NewAmsterdam Pharma website, with an archived replay to follow [2]

Core Insights - Bempedoic acid has received strong endorsement from the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) guidelines as the only non-statin recommended for lowering LDL-C and reducing cardiovascular risk [1][4] - The guidelines emphasize an early and aggressive approach to combination lipid-lowering therapy, which aligns with the company's strategy to develop oral triple combination therapies in the U.S. [1][5] Company Developments - Esperion's President and CEO highlighted the significance of the guideline recognition for both European and U.S. markets, indicating that it will inform upcoming U.S. cholesterol treatment guidelines [2] - The company is strategically positioned to lead in the development of the first oral lipid-lowering triple combination pill in the U.S., which aims to provide unprecedented LDL-C lowering and improved patient adherence [5][16] Product Information - NEXLIZET and NEXLETOL are indicated for patients unable to take statin therapy, with bempedoic acid recommended for achieving LDL-C goals [6][7] - The guidelines recommend the addition of bempedoic acid to maximally tolerated doses of statins for high-risk patients to achieve LDL-C goals [6] Clinical Evidence - The clinical benefits of bempedoic acid are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial, which validates its role in cardiovascular risk reduction [16]

Core Viewpoint - NewAmsterdam Pharma has submitted Marketing Authorization Applications (MAAs) for obicetrapib monotherapy and its fixed-dose combination with ezetimibe to the European Medicines Agency (EMA) for treating primary hypercholesterolemia and mixed dyslipidemia, marking a significant step in providing new LDL-C lowering therapies for patients at risk of cardiovascular disease [1][2][3] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients with elevated low-density lipoprotein cholesterol (LDL-C) who are at risk of cardiovascular disease [1][6] - The company aims to address unmet needs in LDL-lowering therapies that are safe, well-tolerated, and convenient for patients [6] Product Development - Obicetrapib is a novel, oral, low-dose cholesteryl ester transfer protein (CETP) inhibitor, which has shown statistically significant LDL-C reductions in multiple Phase 3 trials, including BROADWAY, BROOKLYN, and TANDEM [2][5] - The BROADWAY trial reported a 33% reduction in LDL-C compared to placebo, while the TANDEM trial achieved a 49% reduction, demonstrating the efficacy of obicetrapib both as a monotherapy and in combination with ezetimibe [7] Partnership and Financials - NewAmsterdam has an exclusive licensing agreement with Menarini for the commercialization of obicetrapib in Europe, which includes an upfront payment of €115 million and potential milestone payments totaling up to €863 million [3][4] - The company is entitled to tiered double-digit percentage royalties on net sales in the Menarini territory, ranging from low double-digits to mid-twenties [1][3] Market Context - Cardiovascular disease remains the leading cause of death globally, with an estimated 17.9 million deaths annually, highlighting the need for effective LDL-lowering therapies [3] - Despite the availability of lipid-lowering therapies, many patients do not achieve their LDL-C targets, indicating a significant market opportunity for new treatments like obicetrapib [3][6]

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]

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]

Financial Data and Key Metrics Changes - The company reported growth in Q2, overcoming headwinds faced in Q1, particularly related to Medicare and overall market conditions [4] - Prescription growth began to exceed expectations around mid-March, with co-pay issues for Medicare patients significantly reduced [5] Business Line Data and Key Metrics Changes - The lead products, NEXLETOL and NEXLASET, have seen increased traction, particularly in the statin intolerant population, which has been positively received by physicians [6][12] - The sales force has effectively communicated the benefits of the products, leading to a doubling or tripling of new prescribers since the statin intolerance campaign [12] Market Data and Key Metrics Changes - In Europe, the company has experienced consistent growth, with Daiichi Sankyo reporting 20-30% growth each quarter since launch [15] - The company is catching up with Daiichi in Europe, indicating a strong competitive position [15] Company Strategy and Development Direction - The company plans to develop a triple combination therapy in the U.S., which includes bempedoic acid, ezetimibe, and two commonly prescribed statins [17][18] - The company is also pursuing international agreements, with Otsuka Pharmaceuticals commercializing the product in Japan and other agreements in Canada, Australia, and Israel [21][22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about reaching profitability soon, with a growth trajectory that supports self-funding for future projects [42][43] - The company is excited about the potential of a new compound targeting primary sclerosing cholangitis (PSC), which represents a significant market opportunity [37][38] Other Important Information - The company has a strong patent portfolio, with potential extensions beyond 2031, which could reshape the company's financial outlook [28][30] - The recent settlement with MicroLabs regarding generic Nexletol is confidential, but management believes it sets a precedent for future negotiations with other ANDA filers [26][29] Q&A Session Summary Question: How are revenues tracking for NEXLETOL and NEXLASET? - Management noted that Q2 is off to a great start, with prescription growth exceeding expectations since mid-March [4][5] Question: What is the current target population for NEXLETOL and NEXLASET? - The focus is on the statin intolerant population, which has been well received by physicians [6] Question: Can you comment on the expansion of the drug in Europe? - Daiichi Sankyo has shown consistent growth in Europe, and the company expects to surpass them eventually [15] Question: What are the plans for a triple combination therapy? - The company is developing a triple combination therapy that could significantly improve patient adherence and outcomes [17][18] Question: What is the timeline for the PSC drug development? - The PSC drug is currently in preclinical stages, with expectations to launch in the early 2030s [41] Question: How does the company view its path to profitability? - Management is optimistic about reaching profitability soon, with a solid growth trajectory and cash position [42][43]