NewAmsterdam Pharma pany N.V.(US:NAMS)2025-11-05 13:00Revenue and Financial Performance - The company has not generated significant revenue from pharmaceutical product sales, primarily relying on a non-refundable upfront amount of $120.9 million (€115.0 million) from the Menarini License[78]. - Revenue for the three months ended September 30, 2025 was $0.3 million, a decrease of $28.8 million or 99% compared to $29.1 million for the same period in 2024, primarily due to the absence of clinical milestones earned in 2025[94]. - For the nine months ended September 30, 2025, revenue was $22.5 million, a decrease of $10.3 million or 31% compared to $32.8 million for the same period in 2024[106]. - The company recognizes revenue from the sale of obicetrapib tablets and active pharmaceutical ingredients, with revenue recognized upon the transfer of control to Menarini[82]. - The December 2024 Offering generated net proceeds of $453.4 million after deducting underwriting discounts and commissions, enhancing the company's capital resources[118]. - The company completed a public offering of 5,871,909 Ordinary Shares at a price of $19.00 per share, generating net proceeds of $190.0 million after expenses[119]. - The company entered into a sales agreement allowing for the issuance of up to $250 million of Ordinary Shares, with no sales made under this agreement during the nine months ended September 30, 2025[120]. Expenses and Losses - Research and development expenses are expected to be significant as the company advances product candidates through clinical trials and pursues regulatory approval[86]. - Research and development expenses decreased by $4.7 million or 13% to $31.0 million for the three months ended September 30, 2025, driven by a $6.6 million decrease in clinical expenses due to the completion of several Phase 3 trials[95][97]. - Selling, general and administrative expenses increased by $6.1 million or 33% to $24.5 million for the three months ended September 30, 2025, primarily due to a $6.3 million increase in personnel expenses[98]. - Loss for the period was $72.0 million for the three months ended September 30, 2025, an increase of $55.4 million compared to a loss of $16.6 million for the same period in 2024[103]. - Total operating expenses for the nine months ended September 30, 2025 were $182.2 million, an increase of $16.3 million compared to $165.9 million for the same period in 2024[105]. - The company incurred an accumulated loss of $687.5 million as of September 30, 2025, and expects to continue incurring significant losses in the foreseeable future[116]. Cash and Liquidity - Cash, cash equivalents, and marketable securities as of September 30, 2025 totaled $756.0 million, providing liquidity for ongoing operations[117]. - The company had cash and cash equivalents of $538.4 million as of September 30, 2025, sufficient to meet estimated obligations of $27.9 million due within one year[130]. - Net cash used in operating activities decreased to $106.9 million for the nine months ended September 30, 2025, from $121.1 million in the same period of 2024[126]. - Net cash used in investing activities increased significantly to $153.8 million in the nine months ended September 30, 2025, primarily due to investments in marketable securities[128]. - Net cash provided by financing activities decreased to $15.8 million for the nine months ended September 30, 2025, compared to $202.9 million in the same period of 2024[129]. Clinical Trials and Product Development - The Phase 3 BROADWAY trial showed a 21% reduction in major adverse cardiovascular events (MACE) endpoint, with ongoing Phase 3 cardiovascular outcomes trial (PREVAIL) expected to conclude by the end of 2026[68]. - Obicetrapib demonstrated statistically significant LDL-C reductions in multiple Phase 3 trials, meeting primary and secondary endpoints[67]. - Approximately 30 million patients in the U.S. do not achieve risk-based LDL-C goals despite lipid-lowering therapy, highlighting a significant market opportunity[72]. - The company aims to develop an LDL-C lowering monotherapy and a fixed-dose combination therapy to address unmet needs in patients with elevated LDL-C[73]. - The company has observed obicetrapib to be well tolerated in over 3,500 patients, with side effects similar in frequency and severity to placebo[67]. Partnerships and Agreements - The company has partnered with Menarini for the commercialization of obicetrapib in Europe, with marketing authorization applications validated by the European Medicines Agency[75]. - The Menarini Supply Agreement includes provisions for the transfer of manufacturing and establishes the company as Menarini's exclusive supplier of obicetrapib products[76]. - Under the Menarini License, the company received a non-refundable upfront payment of €115 million and is eligible for up to €863 million in milestone payments[121][122]. - As of September 30, 2025, the company received €30.0 million in milestone payments and €13.8 million in R&D reimbursements from Menarini[123]. Financial Instruments and Risks - The fair value of derivative warrant liabilities was $44.4 million as of September 30, 2025, with a 1% change in market price affecting the liability by $0.4 million[141]. - The company's exposure to foreign currency risk was $112.8 million as of September 30, 2025, with a potential earnings impact of approximately $1.1 million from a hypothetical 1% change in exchange rates[139].