NewAmsterdam Pharma pany N.V.(NAMS) - 2022 Q4 - Annual Report

Full Year 2022 Financial Results and Corporate Update NewAmsterdam Pharma reported its 2022 financial results, detailing significant corporate and clinical advancements for obicetrapib and a strong cash position Corporate and Clinical Highlights NewAmsterdam Pharma achieved key 2022 milestones, including a successful business combination, a $235 million PIPE financing, and positive ROSE2 Phase 2 trial results - Completed a business combination with FLAC and a concurrent, oversubscribed PIPE financing of approximately $235 million, which is expected to fund operations through 2026[1] - Announced positive topline results from the ROSE2 Phase 2 clinical trial, which evaluated obicetrapib in combination with ezetimibe[1] - Advanced three pivotal Phase 3 trials (BROOKLYN, BROADWAY, and PREVAIL) and initiated a Phase 2 dose-finding study in Japanese patients[1][3] Clinical Pipeline Updates Obicetrapib is advancing through three pivotal Phase 3 trials, with the ROSE2 Phase 2 trial showing a 59% LDL-C reduction and good tolerability - The ROSE2 Phase 2 trial met its primary endpoint, with the combination of obicetrapib and ezetimibe achieving a median LDL-C reduction of 59% compared to 6% for placebo (p<0.0001)[4] - The combination of obicetrapib and ezetimibe was observed to be well-tolerated, with a safety profile comparable to placebo[4] - Three pivotal Phase 3 trials are ongoing: BROOKLYN (for HeFH), BROADWAY (for ASCVD), and PREVAIL (a cardiovascular outcomes trial)[4] - A Phase 2 dose-finding study of obicetrapib was initiated in 108 Japanese patients with dyslipidemia in October 2022[5] Corporate Highlights NewAmsterdam completed its business combination with Frazier Lifesciences Acquisition Corporation (FLAC) in November 2022, raising $328 million gross proceeds, including a $235 million PIPE financing - Completed a business combination with FLAC in November 2022, yielding gross proceeds of approximately $328 million before expenses[8] - The transaction included approximately $93 million from the FLAC trust account and a $235 million oversubscribed PIPE financing co-led by Frazier Healthcare Partners and Bain Capital Life Sciences[8] - Appointed John W Smither to the Board of Directors and as chair of the Audit Committee in February 2023[8] Upcoming Potential Milestones Key upcoming milestones include full ROSE2 data in June 2023, Phase 3 trial enrollment completion by mid-2023, and Japanese Phase 2 results in H2 2023 - June 2023: Present full data from the Phase 2 ROSE2 trial[7] - H2 2023: Select a formulation for a fixed-dose combination of obicetrapib and ezetimibe[7] - Mid-2023: Complete enrollment for Phase 3 BROOKLYN and BROADWAY trials[7] - H2 2024: Announce topline data from BROOKLYN and BROADWAY trials[7] - H2 2023: Announce topline results from the Phase 2 study in Japanese patients and the Phase 2a Alzheimer's biomarker study[7] - H2 2023: Complete enrollment for the Phase 3 PREVAIL trial, with topline data expected in H2 2026[7] Full Year 2022 Financial Results NewAmsterdam's 2022 financials show a cash increase to €439 million, €98 million revenue, and a €78 million net loss due to higher R&D and transaction costs Full Year 2022 Financial Highlights (in millions of Euro) | Metric | FY 2022 | FY 2021 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Cash Position | €439M | €53M | +€386M | Menarini upfront payment and business combination proceeds | | Revenue | €98M | €0M | +€98M | Portion of upfront payment from Menarini license agreement | | R&D Expenses | €82M | €25M | +€57M | Increased costs for ongoing obicetrapib clinical trials | | SG&A Expenses | €22M | €5M | +€17M | Increased personnel, legal, and transaction costs | | Net Loss | €78M | €29M | +€49M | Higher operating expenses and share listing costs | | Net Loss Per Share | €(0.96) | €(1.19) | Improved | N/A | Financial Guidance NewAmsterdam expects its €439 million cash position to fund operations through 2026, extending beyond its three ongoing Phase 3 trial data readouts - The company believes its existing cash of €439 million will fund operations through 2026[9][8] - This financial runway is expected to last beyond the completion and data readouts of the three ongoing Phase 3 trials (BROADWAY, BROOKLYN, and PREVAIL)[9] Consolidated Financial Statements The consolidated financial statements detail NewAmsterdam's significant asset and equity growth in 2022, alongside increased liabilities and a net loss Consolidated Statements of Financial Position As of December 31, 2022, total assets increased to €531.6 million and equity to €484.5 million, driven by cash from financing and licensing Statement of Financial Position (in thousands of Euro) | Account | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Total Assets | €531,583 | €59,782 | | Cash | €438,522 | €53,092 | | Intangible assets | €83,160 | €0 | | Total Liabilities | €47,062 | €9,991 | | Deferred revenue (Current & Non-current) | €17,500 | €0 | | Total Equity | €484,521 | €49,791 | Consolidated Statements of Profit or Loss and Comprehensive Loss For 2022, the company reported €97.5 million revenue but a €78.1 million net loss, primarily due to increased operating expenses and a €60.6 million share listing expense Statement of Profit or Loss (in thousands of Euro) | Account | 2022 | 2021 | | :--- | :--- | :--- | | Revenue | €97,500 | €0 | | Research and development expenses | (€82,230) | (€25,032) | | Selling, general and administrative expenses | (€22,230) | (€4,803) | | Share listing expense | (€60,600) | €0 | | Operating loss | (€67,560) | (€29,835) | | Loss for the year | (€78,052) | (€28,599) | | Basic and diluted loss per share | €(0.96) | €(1.19) |