NewAmsterdam Pharma Company (NAMS) FY 2025 Conference September 05, 2025 10:15 AM ET Company ParticipantsIan Somaiya - CFOConference Call ParticipantsYanan Zhu - Senior Analyst - Biotechnology Equity ResearchYanan ZhuGreat. Thanks, everyone, for being here. My name is Yan Enzhu, and I'm one of the biotech analysts here at Wells Fargo. It is our great privilege to have management teams of NewAmsterdam Pharma with us for this fireside chat. With me on the stage is Ian Somaiya, CFO for the company. Thank you, ...

Financial Data and Key Metrics Changes - The company expects approval in Europe within the next 12 months, with a projected 33% to 36% reduction in LDL-C for monotherapy and approximately 49% for the fixed-dose combination [8][10] - The global market opportunity for the drug is estimated to exceed $8 billion, with potential revenue splits favoring the U.S. [17][18] Business Line Data and Key Metrics Changes - The company has initiated three LDL studies, with positive data released last year supporting the European filing accepted by the EMA [3][4] - The drug shows a unique ability to reduce Lp(a) by 40% to 50%, which is significantly higher than existing therapies [4][47] Market Data and Key Metrics Changes - The pricing strategy in Europe will be determined by the partner Menarini, with a focus on broad access to lipid-lowering therapies [12][16] - The company anticipates a slower launch pace in Europe compared to the U.S. due to country-by-country approval processes [19][20] Company Strategy and Development Direction - The company aims to redefine hyperlipidemia treatment with its drug, focusing on both LDL and Lp(a) reduction [3][4] - The strategy includes leveraging outcomes data to enhance market access and pricing negotiations in the U.S. [22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the drug's unique characteristics and its potential to resonate with both clinicians and patients [5][48] - The company is optimistic about the PREVAIL study's outcomes, expecting to report a MACE benefit of over 20% [35][36] Other Important Information - The company has a strong intellectual property position, with patents extending to 2043 in the U.S. [60] - The collaboration with Menarini is seen as beneficial due to their established presence in the cardiovascular space [17] Q&A Session Summary Question: What is the expected timeline for EU approval? - The company expects approval in the next 12 months, with the outcome study not being a gating factor for the approval process [10][11] Question: How does the pricing strategy work in Europe? - The pricing will be determined by Menarini, with a focus on broad access within established price bands for lipid-lowering therapies [12][16] Question: What is the rationale behind the U.S. filing strategy? - The company aims to launch with the broadest possible label, leveraging outcomes data to enhance market access [22][24] Question: How does the company differentiate its drug from existing therapies? - The drug offers significant reductions in both LDL and Lp(a), addressing residual risks that current therapies do not [47][48] Question: What is the confidence level in the intellectual property position? - The company is confident in its IP estate, with patents in place until 2043 [60]

Core Insights - The Citi Back-to-school Biopharma Conference is being held for the 20th annual time, indicating its significance in the biopharma industry [1] - The conference features key executives from NewAmsterdam, including the CEO and CFO, highlighting the company's involvement and progress in the sector [1][2] Company Highlights - NewAmsterdam has made significant advancements in Phase III clinical trials, showcasing its commitment to research and development in biopharma [2]

NewAmsterdam Pharma Company (NAMS) Conference September 03, 2025 02:30 PM ET Company ParticipantsGeoff Meacham - Managing DirectorMichael Davidson - CEO & Executive Board MemberIan Somaiya - CFOGeoff MeachamAlright. Welcome to the second day of the Citi Back to School Biopharma Conference. This is the twentieth annual. We took a little hiatus last year, but I'm happy that's back. I'm Jeff Mitchell.My team's here as well. New Amsterdam. Thanks, guys, for joining. It's gonna be a good dialogue here. So we hav ...

NAARDEN, The Netherlands and MIAMI, Aug. 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 it will present additional pooled safety and efficacy da ...

Core Insights - The investment represents a multi-million-dollar upgrade in equipment to enhance production capabilities for fixed dose combination (FDC) products [1][4] - The new manufacturing suite at the Sellersville facility will support the production of NewAmsterdam Pharma's investigational non-statin cholesterol medication aimed at reducing LDL-C [2][4] - The partnership between Piramal Pharma Solutions and NewAmsterdam Pharma is crucial for the development and production of the FDC, with significant contributions from Piramal's facilities in India [2][4] Company Developments - The new suite is expected to create over 20 new jobs at the Sellersville site over the next five years, contributing positively to the local economy [3] - The investment reflects a commitment to continuous improvement and operational efficiency, enabling both companies to meet future commercial demands for the FDC product [4] - NewAmsterdam Pharma is focused on developing obicetrapib, a low-dose CETP inhibitor, to address unmet needs in LDL-lowering therapies [5][6] Industry Context - NewAmsterdam Pharma operates in the late-stage clinical biopharmaceutical sector, targeting metabolic diseases with inadequate existing therapies [6] - Piramal Pharma Solutions is a Contract Development and Manufacturing Organization (CDMO) providing comprehensive services across the drug life cycle, enhancing its capabilities through this investment [7][8]

-- Filings both for the obicetrapib monotherapy and obicetrapib plus ezetimibe fixed-dose combination submitted to EMA by our partner, Menarini, for treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia -- -- NewAmsterdam entitled to tiered double-digit percentage royalties ranging from the low double-digits to mid-twenties on net sales in the Menarini Territory and up to an additional €833 million upon the achievement of various clinical, regul ...

NewAmsterdam Pharma Company N.V. (NAMS) came out with a quarterly loss of $0.15 per share versus the Zacks Consensus Estimate of a loss of $0.52. This compares to a loss of $0.51 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +71.15%. A quarter ago, it was expected that this company would post a loss of $0.45 per share when it actually produced a loss of $0.49, delivering a surprise of -8.89%.Over the last four quarters, the ...

– Late Breaking BROADWAY and TANDEM data presented at EAS 2025 and simultaneously published in The New England Journal of Medicine (BROADWAY) and The Lancet (TANDEM) – – BROADWAY Alzheimer's disease analysis presented at AAIC 2025 showed obicetrapib significantly reduced plasma p- tau217 levels versus placebo in both the full analysis set and in ApoE4 carriers, over 12 months, with favorable trends observed in additional Alzheimer's biomarkers – NewAmsterdam Pharma Provides Corporate Update and Reports Seco ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regula ...