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

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS Cautions readers about forward-looking statements, noting inherent risks and uncertainties that may cause actual results to differ materially - This Quarterly Report contains forward-looking statements regarding the Company's future operations, cash flows, financial position, dividend policy, prospects, strategies, objectives, and other future events. These statements are subject to known and unknown risks and uncertainties, and actual results could differ materially from expectations[8][9] - Readers are cautioned not to place undue reliance on these statements, which speak only as of the report date, and to review risk factors described in this report and the annual report on Form 10-K[9][10] PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) Presents unaudited condensed consolidated financial statements, including Balance Sheets, Statements of Operations, Equity, and Cash Flows Condensed Consolidated Balance Sheets Condensed Consolidated Balance Sheet Highlights (USD thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | % Change | | :-------------------------------- | :------------ | :---------------- | :----- | :------- | | Cash and cash equivalents | 563,864 | 771,743 | (207,879) | -26.9% | | Marketable securities, current | 175,298 | 62,447 | 112,851 | 180.7% | | Total current assets | 769,850 | 863,413 | (93,563) | -10.8% | | Total assets | 815,112 | 864,620 | (49,508) | -5.7% | | Total current liabilities | 36,512 | 106,918 | (70,406) | -65.8% | | Total liabilities | 36,615 | 107,120 | (70,505) | -65.8% | | Total shareholders' equity | 778,497 | 757,500 | 20,997 | 2.8% | Condensed Consolidated Statements of Operations and Comprehensive Loss Condensed Consolidated Statements of Operations and Comprehensive Loss (USD thousands, except per share) | Metric (3 months ended June 30) | 2025 | 2024 | Change | % Change | | :------------------------------ | :-------- | :-------- | :-------- | :------- | | Revenue | 19,145 | 2,279 | 16,866 | 740.1% | | Research and development expenses | 27,516 | 38,379 | (10,863) | -28.3% | | Selling, general and administrative expenses | 27,264 | 16,475 | 10,789 | 65.5% | | Operating loss | (35,635) | (52,575) | 16,940 | -32.2% | | Loss for the period | (17,364) | (39,007) | 21,643 | -55.5% | | Basic and diluted net loss per ordinary share | (0.15) | (0.41) | 0.26 | -63.4% | | Metric (6 months ended June 30) | 2025 | 2024 | Change | % Change | | :------------------------------ | :-------- | :-------- | :-------- | :------- | | Revenue | 22,123 | 3,680 | 18,443 | 501.2% | | Research and development expenses | 72,267 | 80,809 | (8,542) | -10.6% | | Selling, general and administrative expenses | 54,416 | 30,928 | 23,488 | 75.9% | | Operating loss | (104,560) | (108,057) | 3,497 | -3.2% | | Loss for the period | (56,891) | (132,774) | 75,883 | -57.1% | | Basic and diluted net loss per ordinary share | (0.48) | (1.45) | 0.97 | -66.9% | Condensed Consolidated Statements of Shareholders' Equity - Total shareholders' equity increased from $757.5 million at December 31, 2024, to $778.5 million at June 30, 2025. Key changes include the issuance of 1,743,136 Ordinary Shares for earnout settlement, exercise of pre-funded warrants, warrants, and stock options, and share-based compensation, partially offset by the total comprehensive loss for the period[21] Condensed Consolidated Statements of Cash Flows Condensed Consolidated Statements of Cash Flows (USD thousands) | Cash Flow Activity (6 months ended June 30) | 2025 | 2024 | Change | | :---------------------------------------- | :-------- | :-------- | :-------- | | 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 | Notes to Unaudited Condensed Consolidated Financial Statements - The Company is a late-stage biopharmaceutical company focused on metabolic diseases, developing obicetrapib. It faces risks common to early-stage biopharmaceutical companies, including dependence on intellectual property, regulatory approvals, and securing additional capital[27] - Revenue for the six months ended June 30, 2025, was $22.1 million, primarily from the Menarini License R&D performance obligation, including $16.1 million from the second development cost reimbursement installment[30][31] Cash, Cash Equivalents, and Marketable Securities (USD thousands) | Category | June 30, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :----------------------------------- | :------------------------- | :----------------------------- | | Cash and cash equivalents | 563,864 | 771,743 | | Marketable securities | 219,470 | 62,447 | | Total | 783,334 | 834,190 | - The derivative earnout liability was settled in full in March 2025, resulting in the issuance of 1,743,136 Ordinary Shares, with a change in fair value recognized through profit and loss of $(3.992) million[35] Share-Based Compensation Expense (USD thousands) | Expense Type (3 months ended June 30) | 2025 | 2024 | | :------------------------------------ | :----- | :---- | | Share options | 12,518 | 8,290 | | Restricted stock units | 2,661 | — | | Total | 15,179 | 8,290 | | Expense Type (6 months ended June 30) | 2025 | 2024 | | :------------------------------------ | :----- | :---- | | Share options | 25,090 | 16,208 | | Restricted stock units | 5,302 | — | | Total | 30,392 | 16,208 | - The Company operates as a single segment focused on cardio-metabolic diseases, with revenue primarily from the Menarini License in Italy[54] Net Loss Per Ordinary Share (USD, except share amounts) | Metric (3 months ended June 30) | 2025 | 2024 | | :------------------------------ | :------------ | :----------- | | Net loss | (17,364) | (39,007) | | Weighted average Ordinary Shares outstanding | 118,556,492 | 94,711,604 | | Net loss per Ordinary Share | (0.15) | (0.41) | | Metric (6 months ended June 30) | 2025 | 2024 | | :------------------------------ | :------------ | :----------- | | Net loss | (56,891) | (132,774) | | Weighted average Ordinary Shares outstanding | 117,347,434 | 91,611,785 | | Net loss per Ordinary Share | (0.48) | (1.45) | - As of June 30, 2025, the Company had estimated maximum cancellation payments for third-party service agreements of $20.5 million[59] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Analyzes the company's financial condition, operational results, liquidity, and critical accounting policies for the period Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on improving patient care in cardiometabolic diseases, particularly by developing obicetrapib, a highly selective CETP inhibitor, for LDL-C lowering[64][65] - Obicetrapib has shown significant reductions in LDL-C, lipoprotein (a), and small LDL particles in multiple Phase 3 and Phase 2 clinical trials (BROADWAY, BROOKLYN, TANDEM, TULIP, ROSE, OCEAN, ROSE2, Japan Phase 2b), with a safety profile comparable to placebo[65][67] - The company aims to commercialize obicetrapib as a monotherapy and fixed-dose combination therapy in the U.S. and has partnered with Menarini for exclusive commercialization rights in most European countries[71][72] Recent Developments - On July 30, 2025, the company announced positive Alzheimer's Disease (AD) biomarker data from the prespecified analysis of its BROADWAY clinical trial[73] - Treatment with obicetrapib 10 mg daily for 12 months resulted in statistically significant lower absolute changes in plasma p-tau217, a key AD biomarker, in both the full analysis set (p=0.0019) and ApoE4 carriers (p=0.0215)[74] Percent Change in AD Biomarkers Among E4/E4 Carriers vs. Placebo (n=29) | Biomarker | Mean % Change | p-value | | :-------- | :------------ | :------ | | p-tau217 | -20.48% | 0.010 | | NFL | -17.31% | 0.020 | | GFAP | -15.24% | 0.006 | | p-tau181 | -13.67% | 0.06 | | Aβ42/40 | -7.96% | 0.013 | | p-tau217/(Aβ42/40) | -22.65% | 0.032 | Components of our Results of Operations - Revenue is solely derived from the Menarini License, with $98.6 million recognized upfront for the license performance obligation and $22.3 million initially deferred for the R&D performance obligation, which has now been fully recognized[78] - Research and development expenses are recognized as incurred, covering clinical and preclinical activities, drug development, manufacturing, and CRO costs. These are expected to remain significant as product candidates advance[82][83] - Selling, general and administrative expenses, including consultant fees, employee costs, legal, marketing, and intellectual property costs, are expected to increase due to organizational growth and commercial preparedness as a public company[84][85] - Interest income is earned on cash, cash equivalents, and marketable securities. Foreign exchange gains/losses are primarily driven by Euro-denominated cash balances and transactions[87][88] Results of Operations Revenue Comparison (USD thousands) | Period | 2025 | 2024 | Change | % Change | | :----- | :----- | :---- | :----- | :------- | | Q2 | 19,145 | 2,279 | 16,866 | 740.1% | | H1 | 22,123 | 3,680 | 18,443 | 501.2% | - The significant increase in revenue was largely due to the recognition of $16.1 million from the second installment of development cost contributions under the Menarini License in Q2 2025[91][103] Research and Development Expenses Comparison (USD thousands) | Period | 2025 | 2024 | Change | % Change | | :----- | :----- | :----- | :------- | :------- | | Q2 | 27,516 | 38,379 | (10,863) | -28.3% | | H1 | 72,267 | 80,809 | (8,542) | -10.6% | - The decrease in R&D expenses was primarily driven by a $15.0 million (Q2) / $23.1 million (H1) decrease in clinical expenses due to the completion of several Phase 3 trials and cost phasing, partially offset by increases in personnel, non-clinical, manufacturing, and regulatory expenses[92][99][104] Selling, General and Administrative Expenses Comparison (USD thousands) | Period | 2025 | 2024 | Change | % Change | | :----- | :----- | :----- | :----- | :------- | | Q2 | 27,264 | 16,475 | 10,789 | 65.5% | | H1 | 54,416 | 30,928 | 23,488 | 75.9% | - The increase in SG&A expenses was mainly due to higher personnel expenses (including share-based compensation), increased marketing and communication expenses for commercial launch preparation, and intellectual property costs[94][100][106][111] Loss for the Period Comparison (USD thousands) | Period | 2025 | 2024 | Change | % Change | | :----- | :------ | :------- | :----- | :------- | | Q2 | (17,364) | (39,007) | 21,643 | -55.5% | | H1 | (56,891) | (132,774)| 75,883 | -57.1% | Liquidity and Capital Resources - As of June 30, 2025, the Company had cash, cash equivalents, and marketable securities totaling $783.3 million, with an accumulated loss of $615.5 million[112][113] - Historical funding sources include private and public share placements, convertible notes, and proceeds from the Menarini License and Business Combination Agreement[113] - The Company completed a December 2024 Offering, raising $453.4 million net, and a February 2024 Offering, raising $190.0 million net, through the issuance of Ordinary Shares and Pre-Funded Warrants[114][115] - An At-the-Market Offering agreement allows for the sale of up to $250 million of Ordinary Shares, though no sales occurred in the six months ended June 30, 2025[116] - The Menarini License provides for an upfront payment, R&D funding (€27.5 million over two years, with €13.8 million received in H1 2025), and potential milestone payments up to €863 million, plus tiered royalties[117][119] - As of June 30, 2025, 2,616,539 outstanding Warrants could generate up to $30.1 million if exercised, but the Company does not include these potential proceeds in liquidity projections due to price dependency[120] - Net cash used in operating activities decreased by $34.5 million in H1 2025 compared to H1 2024, primarily due to increased interest income and Menarini License contributions[122] - Net cash used in investing activities increased significantly by $155.7 million in H1 2025, mainly due to $193.3 million in purchases of available-for-sale debt securities[123][124] - Net cash provided by financing activities decreased by $192.9 million in H1 2025, primarily due to the proceeds from the February 2024 Offering in the prior year[125] Critical Accounting Policies and Estimates - The preparation of consolidated financial statements requires management to make estimates and assumptions affecting reported amounts, based on historical experience, known trends, and market-specific factors. These estimates are continuously evaluated, and changes are recorded in the period they become known[129] Item 3. Quantitative and Qualitative Disclosures About Market Risk Outlines the Company's exposure to interest rate, foreign currency, and other market risks, along with credit and liquidity risks - The Company is exposed to interest rate risk through its cash, cash equivalents, and marketable securities, investing primarily in high-quality financial instruments with maturities of less than one year. A hypothetical 100 basis point change in interest rates is not expected to have a material effect[134] - Foreign currency risk primarily relates to cash and payables denominated in currencies other than the U.S. Dollar, mainly the Euro. As of June 30, 2025, net exposure was $124.3 million, with a hypothetical 1% change in exchange rates potentially impacting future earnings by approximately $1.2 million[135] - Other market price risk stems from derivative warrant liabilities, valued at $20.9 million as of June 30, 2025. A 1% change in the market price of the publicly traded Warrants (NAMSW) would alter the liability's value by $0.2 million[137] - Credit risk is mainly from treasury activities, with cash held in investment-grade bank accounts. Management periodically reviews bank creditworthiness and believes value-added tax receivables are fully recoverable[138][140] Item 4. Controls and Procedures Details management's evaluation of disclosure controls and procedures and reports on internal control changes - Management, including the CEO and CFO, concluded that the Company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[142] - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2025[143] PART II. OTHER INFORMATION Item 1. Legal Proceedings Confirms the Company is not currently involved in any material pending legal proceedings - The Company is not a party to any material pending legal proceedings[146] Item 1A. Risk Factors Updates previously disclosed risk factors, highlighting new risks related to changes in U.S. government policies and tariffs - There have been no material changes to previously disclosed risk factors, except for new risks related to government regulation[147] - Changes in U.S. government policies, including increased tariffs (e.g., a baseline ten percent tariff imposed in April 2025), could adversely affect the Company's business by raising production costs, disrupting supply chains, and negatively impacting global economic conditions[148][149][150] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds Reports no unregistered sales of equity securities or use of proceeds during the period - No unregistered sales of equity securities or use of proceeds occurred during the period[151] Item 3. Defaults Upon Senior Securities Confirms no defaults upon senior securities occurred during the reporting period - There were no defaults upon senior securities during the period[152] Item 4. Mine Safety Disclosures States that this item is not applicable to the Company - This item is not applicable[153] Item 5. Other Information Provides details on changes to Rule 10b5-1 trading arrangements for company officers - On April 4, 2025, CFO Ian Somaiya terminated a Rule 10b5-1 trading arrangement for the potential sale of up to 200,000 Ordinary Shares[155] - On June 30, 2025, CEO Michael Davidson modified his Rule 10b5-1 trading arrangement, allowing for the potential sale of up to 750,000 Ordinary Shares, subject to conditions, expiring October 30, 2026[156] Item 6. Exhibits Lists all exhibits filed as part of this Quarterly Report on Form 10-Q - Exhibits include the English translation of the Deed of Conversion and Articles of Association, Form of Restricted Stock Unit Award Agreement, Employment Agreement for Dr. John Kastelein, and various certifications (302 and 906 certifications)[158] SIGNATURES - The report was signed on August 6, 2025, by Michael Davidson, M.D., Chief Executive Officer and Director, and Ian Somaiya, Chief Financial Officer[161]