NewAmsterdam Pharma pany N.V.(NAMS) - 2024 Q4 - Annual Report

Financial Position - As of December 31, 2024, the company had cash and cash equivalents of $771.7 million, up from $340.5 million as of December 31, 2023, primarily due to proceeds from offerings and milestone achievements[570]. - Cash and cash equivalents as of December 31, 2024, were $771.7 million, with plans to utilize these funds primarily for research and development initiatives[600]. - As of December 31, 2024, the company had cash and cash equivalents of $771.7 million, sufficient to fund estimated obligations of $11.8 million due within one year[617]. - Net cash used in operating activities increased by $17.4 million from $141.2 million in 2023 to $158.6 million in 2024[613]. - Net cash flows provided by financing activities was $659.5 million in 2024, an increase of $650.6 million from 2023[615]. Clinical Trials and Research - The Phase 3 BROADWAY clinical trial demonstrated a statistically significant LDL-C reduction of 33% (p<0.0001) for obicetrapib compared to placebo[572]. - The Phase 3 TANDEM clinical trial achieved an LS mean reduction of LDL-C of 48.6% (p < 0.0001) for the fixed-dose combination of obicetrapib and ezetimibe compared to placebo[573]. - The Phase 3 BROOKLYN clinical trial met its primary endpoint with statistically significant reductions in LDL-C compared to placebo, with p-values <0.0001 for key secondary endpoints[574]. - Approximately 30 million patients in the U.S. do not reach their LDL-C goals despite lipid-lowering therapy, highlighting a significant unmet need in the market[566]. - Research and development expenses are expected to be significant as the company advances obicetrapib through clinical trials and regulatory approval processes[581]. Revenue and Expenses - Revenue increased by $31.5 million, or 223.4%, to $45.6 million for the year ended December 31, 2024, compared to $14.1 million for the year ended December 31, 2023[589]. - Research and development expenses decreased by $8.0 million, or 5.0%, to $151.4 million for the year ended December 31, 2024, compared to $159.4 million for the year ended December 31, 2023[590]. - Selling, general and administrative expenses increased by $32.8 million, or 87.2%, to $70.4 million for the year ended December 31, 2024, compared to $37.6 million for the year ended December 31, 2023[591]. - Loss for the year increased by $64.7 million, to $241.6 million for the year ended December 31, 2024, compared to $176.9 million for the year ended December 31, 2023[595]. - As of December 31, 2024, the accumulated loss was $558.6 million, with expectations of continued significant losses in the foreseeable future[598]. Partnerships and Licensing - The company has partnered with Menarini for the commercialization of obicetrapib in Europe, with plans to pursue U.S. development independently[568]. - The company has not generated revenue from product sales, relying solely on a $120.9 million upfront payment from Menarini for licensing[575]. - Menarini made a non-refundable upfront payment of €115 million and committed to provide €27.5 million for R&D activities over two years[605]. - As of December 31, 2024, the company received a total of €30 million in milestone payments from Menarini, with €25 million received in 2024[606]. Market and Future Outlook - The company anticipates increased expenses as it no longer qualifies as an "emerging growth company" and will face higher reporting requirements[570]. - The company's net exposure to foreign currency risk was $108.6 million, mainly related to the Euro, with a potential change in future earnings of approximately $1.1 million from a 1% change in exchange rates[628]. - The fair value of derivative warrant liabilities and derivative earnout liability as of December 31, 2024, were $37.5 million and $44.8 million, respectively[630]. - The company has not included potential cash proceeds from the exercise of Warrants in its liquidity projections[608].