BioNTech SE(US:BNTX)2022-11-07 15:45Financial Data and Key Metrics Changes - Total revenues for Q3 2022 reached €3.5 billion, contributing to total revenues of €13 billion for the first nine months of the year, reflecting strong performance in the COVID-19 vaccine franchise [11][67] - The company raised its 2022 financial guidance for COVID-19 vaccine revenues to €16 billion to €17 billion, up from a previous estimate of €13 billion to €17 billion [12][79] - Net profit for Q3 2022 was €1.8 billion, compared to €3.2 billion for the same period in 2021, while net profit for the first nine months of 2022 was €7.2 billion, slightly up from €7.1 billion in 2021 [77][78] Business Line Data and Key Metrics Changes - COVID-19 vaccine revenues for Q3 2022 were €3.4 billion, with €12.9 billion for the first nine months, driven by the Omicron-adapted vaccine launches [69][70] - Research and development expenses for Q3 2022 were €34.8 million, significantly lower than €260.4 million in the same period in 2021, while total R&D expenses for the first nine months reached €1 billion, up from €0.7 billion in 2021 [74][75] Market Data and Key Metrics Changes - The company invoiced approximately 300 million doses of the BA.4/BA.5-adapted bivalent vaccine as of mid-October 2022, with approvals for use in over 45 countries [16][18] - The company expects to invoice up to 2.1 billion doses of COVID-19 vaccines in 2022, reflecting some rephasing of deliveries to early 2023 [85] Company Strategy and Development Direction - BioNTech aims to establish a fully integrated global immunotherapy powerhouse, focusing on a technology-agnostic, solution-focused multi-platform strategy [9][10] - The company is expanding its mRNA manufacturing network and has signed a letter of intent for a strategic partnership to establish an mRNA research and innovation center in Victoria, Australia [12][13] Management's Comments on Operating Environment and Future Outlook - Management highlighted the dynamic nature of the COVID-19 pandemic and the need for ongoing adaptation of vaccines to emerging variants [26][27] - The company anticipates a shift in the COVID-19 vaccine market towards a hybrid public-private model in 2023, with expected pricing for adult vaccines in the range of $110 to $130 per dose [86][87] Other Important Information - The company completed the first tranche of its share repurchase program, repurchasing 6,945,530 ADSs at an average price of $143.98 [81][82] - The company plans to submit data to regulatory agencies for its Omicron-adapted bivalent vaccine for children aged six months to four years in early 2023 [36] Q&A Session Summary Question: Duration of BA 4/5 bivalent shot effectiveness and shipment delays - Management indicated that the effectiveness of the BA 4/5 Omicron-adapted vaccines depends on the virus's evolution and ongoing cross-neutralization assays [96][97] - A significant portion of shifted doses were donation doses, and contracts are flexible, allowing for either current or future vaccines to fulfill orders [98][99] Question: PFS difference expectations for melanoma data - Management stated it is too early to define a specific threshold for PFS improvement and emphasized the need for alignment with progress in the field [102][103] Question: Potential distribution of COVID vaccine in China - Management confirmed positive discussions regarding potential distribution in China but stated it is too early to predict specifics about approval and pricing [107] Question: COVID vaccine market volume expectations - Management acknowledged the difficulty in predicting future COVID vaccine volumes but noted the potential for a flu-like business model in the future, with a significant market opportunity [111][113]