[Full Year 2022 Financial Results and Corporate Update](index=1&type=section&id=Full%20Year%202022%20Financial%20Results%20and%20Corporate%20Update) NewAmsterdam Pharma reported its 2022 financial results, detailing significant corporate and clinical advancements for obicetrapib and a strong cash position [Corporate and Clinical Highlights](index=1&type=section&id=Corporate%20and%20Clinical%20Highlights) 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](index=1&type=chunk) - Announced positive topline results from the ROSE2 Phase 2 clinical trial, which evaluated obicetrapib in combination with ezetimibe[1](index=1&type=chunk) - Advanced three pivotal Phase 3 trials (BROOKLYN, BROADWAY, and PREVAIL) and initiated a Phase 2 dose-finding study in Japanese patients[1](index=1&type=chunk)[3](index=3&type=chunk) [Clinical Pipeline Updates](index=1&type=section&id=Clinical%20Pipeline%20Updates) 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](index=4&type=chunk) - The combination of obicetrapib and ezetimibe was observed to be well-tolerated, with a safety profile comparable to placebo[4](index=4&type=chunk) - Three pivotal Phase 3 trials are ongoing: BROOKLYN (for HeFH), BROADWAY (for ASCVD), and PREVAIL (a cardiovascular outcomes trial)[4](index=4&type=chunk) - A Phase 2 dose-finding study of obicetrapib was initiated in 108 Japanese patients with dyslipidemia in October 2022[5](index=5&type=chunk) [Corporate Highlights](index=2&type=section&id=Corporate%20Highlights) 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](index=8&type=chunk) - 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](index=8&type=chunk) - Appointed John W Smither to the Board of Directors and as chair of the Audit Committee in February 2023[8](index=8&type=chunk) [Upcoming Potential Milestones](index=2&type=section&id=Upcoming%20Potential%20Milestones) 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](index=7&type=chunk) - **H2 2023**: Select a formulation for a fixed-dose combination of obicetrapib and ezetimibe[7](index=7&type=chunk) - **Mid-2023**: Complete enrollment for Phase 3 BROOKLYN and BROADWAY trials[7](index=7&type=chunk) - **H2 2024**: Announce topline data from BROOKLYN and BROADWAY trials[7](index=7&type=chunk) - **H2 2023**: Announce topline results from the Phase 2 study in Japanese patients and the Phase 2a Alzheimer's biomarker study[7](index=7&type=chunk) - **H2 2023**: Complete enrollment for the Phase 3 PREVAIL trial, with topline data expected in **H2 2026**[7](index=7&type=chunk) [Full Year 2022 Financial Results](index=2&type=section&id=Full%20Year%202022%20Financial%20Results) 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](index=3&type=section&id=Financial%20Guidance) 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](index=9&type=chunk)[8](index=8&type=chunk) - 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](index=9&type=chunk) [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) 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](index=5&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) 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](index=6&type=section&id=Consolidated%20Statements%20of%20Profit%20or%20Loss%20and%20Comprehensive%20Loss) 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)** |