NewAmsterdam Pharma pany N.V.(NAMS) - 2025 Q2 - Quarterly Results

Corporate Overview & Highlights Q2 2025 Financial & Corporate Highlights NewAmsterdam Pharma announced Q2 2025 financial results and provided a corporate update, highlighting progress in clinical trials, regulatory submissions, and a strong cash position - European marketing authorization application for obicetrapib is on track for 2H25[1] - PREVAIL Phase 3 Cardiovascular Outcomes Trial (CVOT) remains on track[1] - BROADWAY Alzheimer's disease analysis showed obicetrapib significantly reduced plasma p-tau217 levels versus placebo in both the full analysis set and in ApoE4 carriers over 12 months[1] Cash, Cash Equivalents and Marketable Securities | Date | Amount (USD millions) | | :--- | :--- | | June 30, 2025 | 783.3 | | December 31, 2024 | 834.2 | CEO Statement CEO Michael Davidson emphasized obicetrapib's rapid advancement, compelling Phase 3 data showing robust LDL-C reduction and potential in neurodegenerative risk, and the expansion of the clinical program with the planned RUBENS trial - Obicetrapib is rapidly advancing towards patients worldwide, potentially addressing the urgent need for additional cardiovascular disease treatment options[2] - Phase 3 studies reinforce obicetrapib's lipoprotein modifying properties, including robust LDL-C reduction, and suggest a potential role in reducing neurodegenerative risk[2] - Launch of the Phase 3 RUBENS trial is planned for later this year to evaluate obicetrapib in combination with ezetimibe in patients with type 2 diabetes and metabolic syndrome[2] - The company is focused on building out commercial capabilities to support the potential launch of obicetrapib, if approved[2] Clinical Development & Pipeline Obicetrapib Overview Obicetrapib is an oral, low-dose, once-daily CETP inhibitor being developed as a preferred LDL-C lowering therapy for patients at risk of CVD where existing therapies are insufficient or not well-tolerated - Obicetrapib is an oral, low-dose and once-daily cholesteryl ester transfer protein ("CETP") inhibitor[3] - It is being developed as the preferred LDL-C lowering therapy for patients at risk of CVD for whom existing therapies are not sufficiently effective or well-tolerated[3] Key Clinical Trial Updates NewAmsterdam presented late-breaking data from BROADWAY and TANDEM trials, and announced positive topline data from a prespecified Alzheimer's disease biomarker analysis in BROADWAY, showing significant reductions in p-tau217 BROADWAY & TANDEM Data Presentation Late-breaking data from BROADWAY and TANDEM pivotal trials were presented at the European Atherosclerosis Society Congress and published in NEJM and The Lancet - In May 2025, late-breaking data from the BROADWAY and TANDEM pivotal trials were presented at the European Atherosclerosis Society Congress[3] - Data were simultaneously published in The New England Journal of Medicine (BROADWAY) and The Lancet (TANDEM)[3] Alzheimer's Disease Biomarker Analysis Positive topline data from the prespecified AD biomarker analysis in BROADWAY showed statistically significant reductions in p-tau217 - In June 2025, positive topline data from the prespecified AD biomarker analysis in the BROADWAY clinical trial were announced[3] - Statistically significant reductions in p-tau217, a key biomarker of AD pathology, were observed in both the full analysis set (p<0.002, n=1,515) and in ApoE4 carriers (p=0.0215, n=367)[3] - In July 2025, additional results presented at AAIC 2025 showed obicetrapib reduced p-tau217 levels by 20.5% over 12 months in ApoE4/E4 carriers (p=0.010, n=29)[6] Upcoming Milestones & Ongoing Trials Following successful completion of Phase 3 BROADWAY, TANDEM, and BROOKLYN trials, additional data will be announced in 2025, while PREVAIL and REMBRANDT Phase 3 trials are ongoing - NewAmsterdam plans to announce additional data from the BROADWAY, TANDEM, and BROOKLYN trials over the course of 2025[5] PREVAIL Phase 3 Trial The PREVAIL cardiovascular outcomes trial, evaluating obicetrapib in ASCVD patients, completed enrollment of over 9,500 patients - PREVAIL is a cardiovascular outcomes trial (CVOT) evaluating obicetrapib in patients with a history of ASCVD whose LDL-C is not adequately controlled[7] - Enrollment of over 9,500 patients was completed in April 2024[7] REMBRANDT Phase 3 Trial The REMBRANDT trial will evaluate obicetrapib plus ezetimibe FDC on coronary plaque in 300 high-risk ASCVD patients - The REMBRANDT trial will utilize coronary computed tomography angiography imaging to evaluate the effect of obicetrapib plus ezetimibe FDC on coronary plaque[7] - The study is expected to enroll 300 adult participants with high-risk ASCVD[7] RUBENS Phase 3 Trial (Planned) The Phase 3 RUBENS trial is planned to evaluate obicetrapib with ezetimibe in patients with type 2 diabetes and metabolic syndrome - The Phase 3 RUBENS trial is planned for later this year to evaluate obicetrapib in combination with ezetimibe in patients with type 2 diabetes and metabolic syndrome[2] Corporate Activities R&D Day & Conference Calls NewAmsterdam hosted an R&D Day in June 2025 to discuss obicetrapib's clinical development and commercial readiness, and a conference call at AAIC 2025 in July 2025 to discuss BROADWAY AD biomarker analysis results - In June 2025, NewAmsterdam hosted an R&D Day event to discuss obicetrapib's clinical development path and commercial readiness and strategy[7] - In July 2025, a conference call was hosted at AAIC 2025 to discuss the results from the prespecified AD biomarker analysis in the BROADWAY trial[7] Commercial Readiness The company is actively building out its commercial capabilities to support the potential launch of obicetrapib, if approved, and its EMA application through partner Menarini remains on track - The company is focused on building out commercial capabilities to support the potential launch of obicetrapib, if approved[2] - The EMA application through partner Menarini remains on track[2] Financial Performance (Q2 2025) Key Financial Highlights NewAmsterdam Pharma reported a significant increase in revenue for Q2 2025, primarily due to a development cost contribution from Menarini, while reducing R&D expenses and increasing SG&A expenses for commercial readiness, leading to a decreased net loss Revenue Revenue for Q2 2025 increased substantially year-over-year, driven by a development cost contribution from the Menarini license agreement Revenue (USD thousands) | Period | 2025 Q2 | 2024 Q2 | Change (YoY) | | :--- | :--- | :--- | :--- | | Revenue | 19,145 | 2,279 | +16,866 (+740.0%) | - The increase was primarily attributable to the recognition of $16.1 million of revenue related to the second installment of development cost contributions under the license agreement with Menarini[7] Operating Expenses R&D expenses decreased due to lower clinical expenses, partially offset by increased personnel and regulatory costs, while SG&A expenses increased significantly due to higher personnel costs, investments in marketing, and intellectual property filings Research and Development (R&D) Expenses R&D expenses decreased due to lower clinical expenses, partially offset by increased personnel and regulatory costs R&D Expenses (USD thousands) | Period | 2025 Q2 | 2024 Q2 | Change (YoY) | | :--- | :--- | :--- | :--- | | R&D Expenses | 27,516 | 38,379 | -10,863 (-28.3%) | - Decrease primarily due to a decrease in clinical expenses, partially offset by an increase in personnel expenses (including share-based compensation), non-clinical expenses, and regulatory expenses[7] - Share-based payment expenses included with R&D expenses totaled $5.1 million in Q2 2025, compared to $3.0 million for the same period in 2024[7] Selling, General and Administrative (SG&A) Expenses SG&A expenses increased significantly due to higher personnel costs, marketing investments, and intellectual property filings SG&A Expenses (USD thousands) | Period | 2025 Q2 | 2024 Q2 | Change (YoY) | | :--- | :--- | :--- | :--- | | SG&A Expenses | 27,264 | 16,475 | +10,789 (+65.5%) | - Increase primarily due to an increase in personnel costs (including share-based compensation), investments in marketing and communications capabilities, and increased intellectual property costs[7][8] - Share-based payment expenses included with SG&A expenses totaled $10.1 million in Q2 2025, compared to $5.3 million for the same period in 2024[8] Net Loss The net loss for Q2 2025 significantly decreased compared to the same period in 2024, influenced by the revenue increase, R&D expense decrease, and non-cash losses related to derivative liabilities Net Loss (USD thousands) | Period | 2025 Q2 | 2024 Q2 | Change (YoY) | | :--- | :--- | :--- | :--- | | Net Loss | (17,364) | (39,007) | +21,643 (+55.5%) | - The change in net loss is attributed to the individual components of revenue and operating expenses, in addition to non-cash losses related to changes in the fair value of derivative liabilities[8] Cash Position The company's cash, cash equivalents, and marketable securities decreased from December 31, 2024, to June 30, 2025, primarily due to ongoing operating expenditures Cash, Cash Equivalents and Marketable Securities | Date | Amount (USD millions) | | :--- | :--- | | June 30, 2025 | 783.3 | | December 31, 2024 | 834.2 | - The decrease was primarily driven by ongoing operating expenditures[7] Disease Background & Product Information About Obicetrapib Obicetrapib is a novel, oral, low-dose CETP inhibitor designed to overcome limitations of current LDL-lowering treatments, showing statistically significant LDL-lowering with a placebo-like side effect profile in multiple trials, with commercialization rights in Europe exclusively granted to Menarini Group - Obicetrapib is a novel, oral, low-dose CETP inhibitor developed to overcome the limitations of current LDL-lowering treatments[9] - Statistically significant LDL-lowering combined with a side effect profile similar to placebo was observed in Phase 2 (ROSE2, TULIP, ROSE, OCEAN) and Phase 3 (BROOKLYN, BROADWAY, TANDEM) trials[9] - Commercialization rights of obicetrapib in Europe have been exclusively granted to the Menarini Group[9] About Cardiovascular Disease Cardiovascular disease remains the leading cause of death globally, with increasing mortality rates in the U.S. despite available lipid-lowering therapies, highlighting a significant unmet clinical need for improved therapeutic regimens - Cardiovascular disease remains the leading cause of death globally, with U.S. age-adjusted mortality rates increasing by 9% from 2019 through 2022[10] - Despite 269 million lipid-lowering therapy (LLT) prescriptions, 30 million under-treated U.S. adults are not at their risk-based LDL-C goal, including 13 million with ASCVD[10] - Less than 1 in 4 patients with ASCVD achieve an LDL-C goal of less than 70 mg/dL, and only 10% of very high-risk ASCVD patients achieve the goal below 55 mg/dL[10] Detailed Alzheimer's Analysis A pre-specified analysis in the BROADWAY trial assessed plasma biomarkers of Alzheimer's disease over 12 months, particularly in ApoE3/4 or 4/4 carriers, showing statistically significant lower absolute changes in p-tau217 compared to placebo, with favorable trends in other AD biomarkers, and obicetrapib was well-tolerated - A pre-specified analysis in the BROADWAY trial assessed plasma biomarkers of Alzheimer's disease (AD) over 12 months in 1,727 patients, including 367 ApoE4 carriers[11] - Statistically significant lower absolute changes in p-tau217 were observed compared to placebo over 12 months in both the full analysis set (p=0.0019; n=1,515) and in ApoE4 carriers (p=0.0215; n=367)[11] - Favorable trends were observed in additional AD biomarkers including NFL, GFAP, p-tau181, and Aβ42/40 ratio[11] - Obicetrapib was observed to be well-tolerated in BROADWAY, with safety results comparable to placebo[11] About NewAmsterdam Pharma Company Mission & Product Focus NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on improving patient care in metabolic diseases where current therapies are inadequate or poorly tolerated, investigating obicetrapib, alone or in combination with ezetimibe, as an LDL-C lowering therapy for CVD patients - NewAmsterdam Pharma is a late-stage clinical 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[12][13] - The company is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies[13] - These therapies are intended as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated[13] Forward-Looking Statements Risks and Uncertainties This section contains forward-looking statements regarding the company's business plans, commercial opportunities, therapeutic potential of product candidates, clinical trial timings, regulatory filings, and commercialization plans, which are subject to various risks and uncertainties - Forward-looking statements cover the Company's business and strategic plans, commercial opportunity, therapeutic potential of product candidates, clinical trial timings, regulatory filings and approvals, and commercialization plans[14] - These statements are subject to a number of risks and uncertainties, including changes in business conditions, risks related to regulatory approval, clinical trial outcomes, competitive product candidates, and intellectual property[14] - The Company does not undertake any obligation to update these forward-looking statements, except as may be required by law[14] Contacts Company, Media & Investor Relations Provides contact information for Company, Media, and Investor relations - Contact information is provided for Matthew Philippe (Company Contact), Christian Edgington (Media Contact), and Austin Murtagh (Investor Contact)[15][16] Condensed Consolidated Financial Statements Condensed Consolidated Balance Sheet The balance sheet shows a decrease in total assets from $864.6 million at December 31, 2024, to $815.1 million at June 30, 2025, primarily driven by a decrease in cash and cash equivalents, while total liabilities also decreased significantly Balance Sheet Highlights (USD thousands) | Item | June 30, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Total Assets | 815,112 | 864,620 | (49,508) | | Cash and cash equivalents | 563,864 | 771,743 | (207,879) | | Marketable securities, current | 175,298 | 62,447 | 112,851 | | Total Liabilities | 36,615 | 107,120 | (70,505) | | Derivative warrant liabilities | 20,932 | 37,514 | (16,582) | | Total Shareholders' Equity | 778,497 | 757,500 | 20,997 | - The decrease in total assets was primarily due to a reduction in cash and cash equivalents, partially offset by an increase in current marketable securities[18] - Total liabilities decreased significantly, mainly due to a reduction in derivative earnout liability and derivative warrant liabilities[18] Condensed Consolidated Statements of Operations and Comprehensive Loss For the three months ended June 30, 2025, revenue increased significantly, operating loss decreased, and net loss improved compared to the prior year, with similar trends for the six-month period Statements of Operations (USD thousands) | Item | Q2 2025 | Q2 2024 | Change (YoY) | 6M 2025 | 6M 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Revenue | 19,145 | 2,279 | +16,866 | 22,123 | 3,680 | +18,443 | | Operating loss | (35,635) | (52,575) | +16,940 | (104,560) | (108,057) | +3,497 | | Loss for the period | (17,364) | (39,007) | +21,643 | (56,891) | (132,774) | +75,883 | - Interest income increased for both the three and six months ended June 30, 2025, compared to the prior year periods[20] - Fair value changes in earnout and warrants significantly impacted other income (expense) for both periods[20] Condensed Consolidated Statements of Mezzanine Equity and Shareholders' Equity Total shareholders' equity increased from $757.5 million at December 31, 2024, to $778.5 million at June 30, 2025, primarily due to issuance of earnout shares, exercise of stock options, and share-based compensation, partially offset by the accumulated loss for the period Total Shareholders' Equity (USD thousands) | Date | Amount | | :--- | :--- | | June 30, 2025 | 778,497 | | December 31, 2024 | 757,500 | - The increase in equity was driven by the issuance of earnout shares ($40.8 million), exercise of stock options ($2.99 million), and share-based compensation ($15.18 million), partially offset by the accumulated loss for the period ($17.36 million)[21] Condensed Consolidated Statements of Cash Flows For the six months ended June 30, 2025, net cash used in operating activities decreased compared to the prior year, while net cash used in investing activities significantly increased, and net cash provided by financing activities decreased substantially, resulting in an overall decrease in cash at period-end Cash Flow Highlights (Six Months Ended June 30, USD thousands) | Item | 2025 | 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | (74,139) | (108,581) | +34,442 | | Net cash used in investing activities | (156,281) | (594) | (155,687) | | Net cash provided by financing activities | 9,944 | 202,838 | (192,894) | | Net change in cash | (220,476) | 93,663 | (314,139) | | Cash at the end of the period | 563,864 | 430,708 | +133,156 | - Net cash used in investing activities significantly increased in 2025 due to purchases of available-for-sale debt securities ($193.3 million)[23] - Net cash provided by financing activities decreased substantially in 2025 compared to 2024, which included significant proceeds from the February 2024 offering of Ordinary Shares and Pre-Funded Warrants[23]