Financial Performance - Total revenues for Q4 2023 were €1,479.0 million, a decrease of 65.4% compared to €4,278.3 million in Q4 2022. For the full year 2023, total revenues were €3,819.0 million, down 78.0% from €17,310.6 million in 2022[20]. - Net profit for Q4 2023 was €457.9 million, a decline of 80.0% from €2,278.7 million in Q4 2022. For the full year 2023, net profit was €930.3 million, down 90.2% from €9,434.4 million in 2022[7]. - Diluted earnings per share for Q4 2023 were €1.90, compared to €9.26 in Q4 2022, representing a decrease of 79.5%. For the full year 2023, diluted earnings per share were €3.83, down 89.9% from €37.77 in 2022[8]. - Operating profit for the three months ended December 31, 2023, was €457.9 million, compared to €205.3 million for the same period in 2022, representing a 122% increase[96]. - Profit before tax for the three months ended December 31, 2023, was €663.2 million, down from €3,172.6 million in the same period of 2022, indicating a significant decline[96]. Research and Development - Research and development (R&D) expenses for Q4 2023 were €577.8 million, an increase of 13.3% from €509.8 million in Q4 2022. For the full year 2023, R&D expenses were €1,783.1 million, up 15.9% from €1,537.0 million in 2022[22]. - BioNTech aims to achieve product approvals in ten oncological indications by 2030, with plans for ten or more potentially registrational oncology trials running by the end of 2024[19]. - The company has 10 ongoing Phase 2 and 3 trials in its oncology pipeline, with plans for its first oncology launch in 2026 and aims for ten indication approvals by 2030[56]. - A pivotal Phase 2 clinical trial in relapsed/refractory germ cell tumors is planned to start in 2024[41]. - BioNTech initiated three first-in-human Phase 1 clinical trials for vaccine candidates addressing shingles, tuberculosis, and mpox in 2023[68]. Cash and Investments - Cash and cash equivalents, along with security investments, reached €17.7 billion as of December 31, 2023, comprising €11.7 billion in cash and €6.0 billion in security investments[24]. - Cash and cash equivalents as of December 31, 2023, were €11,663.7 million, down from €13,875.1 million at the end of the previous year[97]. - The company reported finance income of €162.2 million in Q4 2023, a significant increase from €38.8 million in Q4 2022[78]. - Net cash flows from operating activities for the three months ended December 31, 2023, were €850.9 million, slightly up from €829.2 million in the previous year[96]. - Net cash flows used in investing activities for the three months ended December 31, 2023, were €(2,695.1) million, compared to €(161.0) million in the same period of 2022[97]. Strategic Partnerships and Collaborations - The company delivered over 400 million COVID-19 vaccine doses worldwide in 2023, including the XBB.1.5 variant-adapted monovalent COVID-19 vaccine[15]. - BioNTech's collaboration with Pfizer is crucial for revenue generation, with potential impacts from inventory write-downs by Pfizer affecting BioNTech's revenues[52]. - BioNTech aims to reach up to 10,000 patients with personalized mRNA cancer immunotherapies by 2030 through a partnership with the UK government[69]. - The company has established a multi-year partnership with the State of Victoria, Australia, to set up a clinical-scale mRNA manufacturing facility and an mRNA Innovation Center in Melbourne[69]. Corporate Governance and ESG - BioNTech's ESG rating from ISS is "Prime" with an overall corporate rating of B-, placing it among the top 10% of rated companies in the pharmaceutical sector[46]. - BioNTech's near-term science-based emissions reduction targets have been approved by the Science Based Targets initiative, aligning with the UN's Paris Climate Agreement[72]. Future Outlook - The 2024 revenue guidance is set between €2.5 billion and €3.1 billion, with R&D expenses projected at €2.4 billion to €2.6 billion[11]. - BioNTech expects group revenue for the full 2024 financial year to be in the range of €2.5 - €3.1 billion, reflecting various assumptions including COVID-19 vaccine uptake and regulatory approvals[52]. - The company plans to invest in a research and development hub in Cambridge, UK, which is expected to employ over 70 additional scientists[69]. Acquisitions and Enhancements - The acquisition of InstaDeep Ltd added approximately 290 skilled professionals to BioNTech, enhancing its capabilities in AI and ML technologies[69]. - The company completed construction of its first proprietary plasmid DNA manufacturing facility in Marburg, Germany, enhancing its production capabilities[44].
BioNTech SE(BNTX) - 2023 Q4 - Annual Report