BioNTech SE(BNTX) - 2025 Q1 - Quarterly Report

Financial Performance - Revenues for the three months ended March 31, 2025, were €182.8 million, a decrease of 2.6% compared to €187.6 million in the same period of 2024[6]. - The net loss for the first quarter of 2025 was €415.8 million, compared to a net loss of €315.1 million in the first quarter of 2024, representing a 32% increase in losses[6][8]. - Basic and diluted loss per share for Q1 2025 was €1.73, compared to €1.31 in Q1 2024[6]. - The company reported a comprehensive loss of €478.8 million for the first quarter of 2025, compared to a comprehensive loss of €292.8 million in the same period of 2024[8][12]. - Other revenues declined to €49.8 million in Q1 2025 from €63.4 million in Q1 2024, primarily due to lower contracted capacities in pandemic preparedness[33]. Research and Development - Research and development expenses increased to €525.6 million, up 3.9% from €507.5 million year-over-year[6]. - Research and development expenses rose by €18.1 million, or 4%, from €507.5 million in Q1 2024 to €525.6 million in Q1 2025, primarily due to late-stage clinical studies[38]. - The acquisition of Biotheus was completed on January 31, 2025, enhancing BioNTech's oncology strategy and expanding its R&D capabilities in China[46]. - BioNTech's diversified product pipeline includes investigational mRNA immunotherapies and other therapeutic approaches, positioning it as a pioneer in individualized treatment strategies[127][130]. Assets and Liabilities - Total assets as of March 31, 2025, were €21.18 billion, down from €22.53 billion at the end of 2024, reflecting a decrease of 6%[10]. - Cash and cash equivalents increased to €10.18 billion as of March 31, 2025, compared to €9.76 billion at the end of 2024, marking a 4.3% increase[10][14]. - Total equity as of March 31, 2025, was €18.93 billion, down from €19.41 billion at the end of 2024, a decrease of 2.5%[10]. - Other financial assets increased significantly to €2.29 billion from €1.25 billion, indicating a growth of 83%[10]. - Other financial liabilities decreased by €969.7 million during the three months ended March 31, 2025, primarily due to the settlement of contractual disputes[62]. Patent and Legal Matters - CureVac filed a lawsuit against BioNTech alleging infringement of five European patents related to Comirnaty, with a hearing held on August 15, 2023, and a ruling on EP'122 expected on December 28, 2023[87]. - Moderna filed lawsuits against BioNTech alleging infringement of EP'949 and EP'565, with the UK High Court finding EP'565 invalid and EP'949 valid and infringed[101]. - BioNTech intends to vigorously defend against all patent infringement claims and considers the matters as contingent liabilities[97]. - BioNTech believes it has strong defenses against the allegations and considers the matters as contingent liabilities, with no provision recognized at the balance sheet date due to uncertainty in potential outcomes[110][112][114]. COVID-19 Vaccine Developments - As of March 2025, BioNTech's COVID-19 vaccine, Comirnaty, has been authorized or approved in over 180 countries, with more than 4.9 billion doses shipped globally[135]. - BioNTech is preparing for vaccine adaptation for the upcoming 2025/2026 season, pending necessary approvals[135]. - Continued demand for COVID-19 vaccinations is expected, particularly for high-risk populations, as the virus evolves[139]. - BioNTech and Pfizer's Omicron JN.1 and KP.2-adapted COVID-19 vaccines received regulatory approvals in over 40 countries[138]. Clinical Trials and Product Candidates - The company has multiple active clinical trials across various oncology product candidates, including BNT111 and BNT116[145]. - BNT111 trial met its primary efficacy outcome, showing significant improvement in objective response rate for melanoma patients[152]. - BNT113 is being evaluated in a global Phase 2/3 trial for HPV16+ head and neck cancer[153]. - Ongoing Phase 2 clinical trial for autogene cevumeran in Stage II/III colorectal cancer aims to enroll approximately 327 patients, with primary endpoint being disease-free survival (DFS) and first data expected in late 2025 or early 2026[157]. Corporate Governance - Ramón Zapata-Gomez has been appointed as the new Chief Financial Officer effective July 1, 2025, succeeding Jens Holstein[123].