NewAmsterdam Pharma pany N.V.(NAMS)2023-03-31 20:31Revenue and Financial Performance - Revenue increased by €97.5 million, from nil for the year ended December 31, 2021 to €97.5 million for the year ended December 31, 2022, driven by the Menarini License upfront payment[605]. - The company reported a loss before tax of €78.1 million for the year ended December 31, 2022, compared to a loss of €28.6 million in 2021[604]. - Loss for the year increased by €49.5 million, from a loss of €28.6 million in 2021 to a loss of €78.1 million in 2022, mainly due to increased research and development expenses and share listing expenses[618]. - As of December 31, 2022, the company had an accumulated loss of €119.4 million and expects to continue incurring significant losses in the foreseeable future[620]. - Cash as of December 31, 2022, was €438.5 million, which is expected to fund operations through 2026 based on the current operating plan[622]. Expenses - Research and development expenses rose significantly to €82.2 million in 2022, up from €25.0 million in 2021, reflecting increased clinical trial activities[604]. - Selling, general and administrative expenses increased to €22.2 million in 2022 from €4.8 million in 2021, due to higher costs associated with being a public company[604]. - The total operating expenses for 2022 were €165.1 million, compared to €29.8 million in 2021, marking an increase of €135.2 million[604]. - Research and development expenses increased by €57.2 million, or 228%, from €25.0 million in 2021 to €82.2 million in 2022, primarily due to higher clinical trial costs[606]. - Selling, general and administrative expenses rose by €17.4 million, or 363%, from €4.8 million in 2021 to €22.2 million in 2022, driven by increased personnel and transaction costs[610]. - Share listing expenses amounted to €60.6 million in 2022, resulting from the Business Combination, reflecting the excess of the fair value of equity instruments issued over the fair value of net assets contributed[612]. Research and Development - Obicetrapib demonstrated a 51% median lowering of LDL-C from baseline at a 10 mg dose level in the Phase 2b ROSE trial[583]. - The company expects research and development expenses to increase substantially as it advances obicetrapib through clinical trials[595]. - The company has partnered with Menarini for the commercialization of obicetrapib in most European countries, pending marketing approval[585]. Foreign Currency and Risk Exposure - As of December 31, 2022, the company's net exposure to foreign currency risk was €268.2 million, up from €15.9 million as of December 31, 2021[602]. - The company recognized significant foreign exchange losses in 2022 due to holding a substantial U.S. Dollar balance while its functional currency is Euro[857]. - Net foreign exchange losses decreased by €10.7 million, from a gain of €1.4 million in 2021 to a loss of €9.3 million in 2022, primarily due to the appreciation of the U.S. Dollar[615]. - For the year ended December 31, 2022, the U.S. Dollar depreciation by 10% resulted in a loss of €24,361 thousand before tax, while a 10% appreciation led to a gain of €29,775 thousand[859]. Financing Activities - The company completed a Business Combination with FLAC, resulting in gross proceeds of 2.6 million in transaction costs[632]. - The PIPE Financing involved the issuance of 23,460,000 Ordinary Shares at 234.6 million[631]. - The company reported net cash flows from financing activities of €375.2 million for the year ended December 31, 2022, compared to €69.0 million in 2021, reflecting the impact of the Business Combination[639]. Contractual Obligations and Liabilities - The company has estimated maximum contractual obligations of €16.6 million due within one year and €5.1 million due in more than a year related to third-party service agreements[640]. - As of December 31, 2022, derivative warrant liabilities amounted to €3.9 million and derivative earnout liability was €7.1 million[860]. - The company is responsible for 50% of certain development costs incurred by Menarini in the development of Licensed Products in the Menarini Territory[646]. - The company has not included potential cash proceeds from the exercise of Warrants in its liquidity projections, indicating uncertainty regarding their exercise[634]. Other Financial Information - For the year ended December 31, 2022, net cash provided by operating activities was €8.0 million, a significant improvement of €33.1 million compared to a net cash outflow of €25.2 million in 2021[635][636]. - A 15% increase in share price under derivative warrant liabilities (NAMSW) would decrease profit or loss before tax by €583 thousand, while a 15% decrease would increase it by the same amount[862]. - A 15% increase in share price under derivative earnout liability (NAMS) would decrease profit or loss before tax by €1,058 thousand, while a 15% decrease would increase it by the same amount[862]. - The company is exposed to credit risk primarily from treasury activities, with available cash held in banks with investment grade credit ratings[863]. - The CEO repaid a loan of €709 thousand on July 19, 2022, which was secured and bore interest[864]. - The company is currently engaged in research and development activities and does not have any sales, allowing it to reclaim recoverable Value Added Tax (VAT)[865].