BioNTech SE(BNTX) - 2025 Q3 - Quarterly Report

Financial Performance - Revenues for the three months ended September 30, 2025, were €1,518.9 million, a 21.9% increase compared to €1,244.8 million for the same period in 2024[5] - Net loss for the three months ended September 30, 2025, was €28.7 million, compared to a net profit of €198.1 million in the same period of 2024[7] - Other operating income for the nine months ended September 30, 2025, was €154.6 million, compared to €103.0 million in the same period of 2024[5] - Comprehensive loss for the nine months ended September 30, 2025, was €954.7 million, compared to a comprehensive loss of €1,021.4 million in the same period of 2024[7] - Total revenues for the three months ended September 30, 2025, were €1,518.9 million, an increase of 21.9% from €1,244.8 million in the same period of 2024[39] - COVID-19 vaccine revenues decreased to €853.3 million in Q3 2025 from €1,113.9 million in Q3 2024, representing a decline of 23.4%[39] - Revenues from out-licensing reached €613.0 million in Q3 2025, with no corresponding revenues in Q3 2024[39] Expenses and Liabilities - Research and development expenses for the nine months ended September 30, 2025, were €1,599.5 million, a decrease of 2.6% from €1,642.4 million in the same period of 2024[5] - The company reported finance income of €96.8 million for the three months ended September 30, 2025, down from €156.2 million in the same period of 2024[5] - The company reported a negative other operating result of €704.2 million in Q3 2025, primarily due to expenses from contractual disputes[50] - General and administrative expenses decreased by €11.2 million, or 8%, to €121.2 million in Q3 2025, and by €74.5 million, or 18%, year-to-date[48] - The company’s total current liabilities as of September 30, 2025, were €2,222.5 million, a decrease from €2,523.2 million as of December 31, 2024[9] Cash and Assets - Cash and cash equivalents as of September 30, 2025, totaled €10,092.9 million, an increase from €9,761.9 million as of December 31, 2024[9] - Total assets as of September 30, 2025, were €21,341.1 million, down from €22,529.7 million as of December 31, 2024[9] - Total equity as of September 30, 2025, was €18,477.3 million, a decrease from €19,411.1 million as of December 31, 2024[9] - Cash and cash equivalents as of September 30, 2025, were €10,092.9 million, compared to €9,624.6 million as of September 30, 2024[13] - Cash and security investments decreased by €654.3 million compared to December 31, 2024[71] Strategic Partnerships and Acquisitions - BioNTech's collaboration with Bristol-Myers Squibb involves a 50:50 sharing of development and manufacturing costs, indicating a strategic partnership for future growth[32] - The company entered a strategic partnership with Bristol-Myers Squibb, receiving an upfront payment of $1.5 billion and potential total payments of up to $9.6 billion[41][42] - The acquisition of Biotheus was completed on January 31, 2025, enhancing the company's oncology strategy and expanding its R&D capabilities in China[53][55] - The total consideration for the acquisition of Biotheus was €280.1 million, with an upfront payment of €767.8 million and contingent consideration of €79.6 million[56] Research and Development - The company is focused on developing a robust pipeline of individualized, patient-centric therapeutic approaches in oncology and infectious diseases[16] - The company is actively engaged in clinical trials for its authorized products and candidates, with a focus on addressing cancer heterogeneity and interindividual variability[145] - BioNTech has a robust pipeline of product candidates in oncology, including multiple mRNA cancer immunotherapies and next-generation immunomodulators[163] - The company has identified two high-priority oncology programs: mRNA cancer immunotherapy programs (iNeST and FixVac) and the late-stage bispecific antibody pumitamig (BNT327), targeting PD-L1 and VEGF-A[168][182] Legal and Regulatory Matters - The company is currently involved in multiple ongoing patent litigations, including cases filed by Moderna and GlaxoSmithKline[121][124] - BioNTech believes it has strong defenses against the patent infringement allegations and considers these matters as contingent liabilities[121][129] - The Düsseldorf Regional Court is set to render its infringement ruling on European Patent EP'122 on December 28, 2023, while suspending rulings on four other IP rights pending validity decisions[97] - The Federal Patent Court of Germany nullified EP'122 on December 19, 2023, with an appeal by CureVac currently pending[101] Environmental, Social, and Governance (ESG) - BioNTech improved its overall ESG rating from B- to B in the 2024 Corporate Rating, placing it in the top 10% of companies in the Pharmaceuticals and Biotechnology sector[149] - The company achieved a score of 51 out of 100 in the 2025 S&P Corporate Sustainability Assessment, reflecting significant improvement from previous years[149] - BioNTech's commitment to environmental, social, and governance (ESG) factors is reflected in its "Prime" status from ISS ESG for 2024[149] COVID-19 Vaccine Developments - BioNTech's COVID-19 vaccine, Comirnaty, has shipped 5 billion doses globally and is authorized in over 180 countries as of March 2025[151] - The company anticipates continued demand for COVID-19 vaccinations, particularly for at-risk populations, due to the evolving nature of SARS-CoV-2 and the risk of severe disease[155] - BioNTech's LP.8.1-adapted COVID-19 vaccine received FDA approval for use in adults aged 65 and older, as well as in individuals aged 5 to 64 with underlying conditions[160] - BioNTech's LP.8.1-adapted COVID-19 vaccine was made available for shipment to EU member states following European Commission authorization in August 2025[159]