| --- | --- | --- | --- | --- | |--------------------------------------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | nd | | | | | | 2 Quarter 2024 | | | | | | | | | | | | Financial Results & Corporate Update | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | August 5, 2024 | | | | | | | | | | | | ...

Financial Performance - Revenues for Q2 2024 were €128.7 million, a decrease of 23.2% compared to €167.7 million in Q2 2023[5] - The operating loss for Q2 2024 was €966.2 million, compared to a loss of €563.3 million in Q2 2023[5] - The net loss for the period in Q2 2024 was €807.8 million, compared to a loss of €190.4 million in Q2 2023[7] - Total revenues for the three months ended June 30, 2024, were €128.7 million, down from €167.7 million in the same period of 2023, with COVID-19 vaccine revenues at €71.9 million compared to €158.2 million[25] - For the six months ended June 30, 2024, total revenues were €316.3 million, significantly lower than €1,444.7 million in the same period of 2023[25] - The company reported a basic loss per share of €3.36 for Q2 2024, compared to a loss of €0.79 per share in Q2 2023[5] - The company experienced a comprehensive loss of €915.4 million for Q2 2024, compared to a loss of €182.2 million in Q2 2023[7] Research and Development - Research and development expenses increased significantly to €584.6 million in Q2 2024, up 56.5% from €373.4 million in Q2 2023[5] - The company is focusing on expanding its research and development efforts, as indicated by the significant increase in R&D expenses[5] - BioNTech's research and development efforts continue to focus on mRNA vaccines and therapeutics, cell and gene therapies, and other innovative approaches to address unmet medical needs[15] - Research and development expenses increased by €211.2 million (57%) to €584.6 million for the three months and by €384.7 million (54%) to €1,092.1 million for the six months, driven by clinical studies and increased headcount[29] Cash and Assets - Total assets decreased to €22,237.9 million as of June 30, 2024, down from €23,006.3 million at the end of 2023[9] - Cash and cash equivalents were €10,376.7 million as of June 30, 2024, a decrease from €11,663.7 million at the end of 2023[9] - Cash and cash equivalents as of June 30, 2024, were €10,376.7 million, down from €14,166.6 million at the end of June 2023[13] - The company reported a net cash inflow from operating activities of €1,627.2 million for the three months ended June 30, 2024, compared to €4,386.7 million in the same period of 2023[13] Equity and Liabilities - Total equity decreased to €19,072.3 million as of June 30, 2024, down from €20,245.9 million at the end of 2023[9] - The total carrying amount of financial assets measured at fair value was €5,411.0 million, with money market funds contributing €5,409.7 million[46] - As of June 30, 2024, the total financial liabilities not measured at fair value amounted to €1,088.4 million, including lease liabilities of €254.6 million and trade payables of €881.5 million[46] - Total provisions amounted to €372.9 million, up from €278.1 million as of December 31, 2023, representing a 34% increase[58] Legal Matters - The company is involved in multiple ongoing intellectual property disputes, with significant uncertainties regarding potential liabilities[62] - The Düsseldorf Regional Court has suspended infringement rulings related to several patents pending validity decisions, indicating ongoing legal complexities[68] - The Federal Patent Court of Germany nullified the EP'122 Patent, with an appeal currently pending from CureVac[70] - BioNTech is currently involved in multiple patent litigations, including cases filed by Moderna in the US, UK, Netherlands, Ireland, and Belgium, with outcomes remaining uncertain[85] COVID-19 Vaccine Developments - BioNTech's COVID-19 vaccine, Comirnaty, has been authorized or approved in over 180 countries, with more than 4.8 billion doses shipped globally as of December 2023[104] - The company is preparing for the commercial launch of a SARS-CoV-2 variant-adapted vaccine for the 2024/2025 fall and winter season, pending regulatory approval[106] - The Omicron JN.1 sublineages account for the majority of COVID-19 cases globally, necessitating updated vaccines for better protection against symptomatic and severe disease[107] - The European Medicines Agency recommended marketing authorization for the Omicron JN.1-adapted monovalent COVID-19 vaccine for individuals 6 months and older[109] Corporate Strategy and Partnerships - BioNTech's corporate strategy includes strengthening its clinical pipeline and technology platforms through strategic partnerships and acquisitions[100] - The company is actively pursuing market expansion and new product development to enhance its portfolio and address global health challenges[15] - BioNTech's management emphasizes the importance of collaboration with partners, such as Pfizer, to optimize revenue sharing and enhance product offerings[19] Clinical Trials and Product Pipeline - The company has a robust and diversified product pipeline across oncology and infectious diseases, leveraging multiple technology platforms[98] - BioNTech is developing BNT211 for germ cell tumors, with a pivotal Phase 2 trial expected to start in 2025 based on encouraging Phase 1 data[138] - The ongoing Phase 2 trial of autogene cevumeran (BNT122) in adjuvant colorectal cancer is expected to enroll about 200 patients, with primary endpoint being disease-free survival (DFS)[126] - A randomized Phase 2 trial for autogene cevumeran in pancreatic ductal adenocarcinoma (PDAC) is recruiting 260 patients, with DFS as the primary endpoint[129]

Announced positive data from multiple mRNA cancer vaccine clinical trials, including topline results from the ongoing Phase 2 evaluating FixVac candidate BNT111 Launched updated variant-adapted COVID-19 vaccine in the European Union ("EU"), received approval in the United Kingdom and initiated rolling supplemental Biologics Licensing Application ("sBLA") with the United States Food and Drug Administration ("U.S. FDA") Reiterates guidance for total revenues in the range of €2.5-3.1 billion Reports second qua ...

Announced positive data from multiple mRNA cancer vaccine clinical trials, including topline results from the ongoing Phase 2 evaluating FixVac candidate BNT111 Launched updated variant-adapted COVID-19 vaccine in the European Union ("EU"), received approval in the United Kingdom and initiated rolling supplemental Biologics Licensing Application ("sBLA") with the United States Food and Drug Administration ("U.S. FDA") Reiterates guidance for total revenues in the range of €2.5-3.1 billion Reports second qua ...

MAINZ, Germany, July 30, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") today announced positive topline data from the ongoing Phase 2 clinical trial (EudraCT No.: 2020-002195-12; NCT04526899) in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-(L)1-containing treatment. The randomized trial evaluates the clinical activity and safety of the investigational mRNA cancer immunotherapy BNT111 in combination with Libtayo® (cemipl ...

MAINZ, Germany, July 30, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") today announced positive topline data from the ongoing Phase 2 clinical trial (EudraCT No.: 2020-002195-12; NCT04526899) in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-(L)1-containing treatment. The randomized trial evaluates the clinical activity and safety of the investigational mRNA cancer immunotherapy BNT111 in combination with Libtayo® (cemipl ...

MAINZ, Germany, July 22, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") will announce its financial results for the second quarter 2024 on Monday, August 5, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. EDT (2:00 p.m. CEST) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. About BioNTech To access the live conference call via telephone, please register via ...

MAINZ, Germany, July 22, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") will announce its financial results for the second quarter 2024 on Monday, August 5, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. EDT (2:00 p.m. CEST) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. To access the live conference call via telephone, please register via this link. Onc ...

Core Viewpoint - The European Medicines Agency (EMA) has recommended updating COVID-19 vaccines to target the new JN.1 variant, which is expected to enhance vaccine effectiveness as the virus continues to evolve [1][4][17]. Group 1: Vaccine Development and Approval - Pfizer and BioNTech's Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY® JN.1) has received a recommendation for marketing authorization from the EMA's Committee for Medicinal Products for Human Use (CHMP) for individuals aged 6 months and older [4][17]. - The recommendation is based on comprehensive clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the vaccine, which shows improved immune response against multiple JN.1 sublineages compared to previous versions [4][17]. - The updated vaccine is ready for immediate shipment to EU member states upon authorization by the European Commission, which is expected to make a decision soon [17]. Group 2: Vaccine Composition and Administration - The COMIRNATY vaccine is administered as a single dose for individuals aged 5 years and older, while infants and children aged 6 months to 4 years receive a three-dose series [5][6]. - The vaccine's formulation includes mRNA encoding for the spike protein of the JN.1 variant, which is designed to enhance the immune response against this specific lineage [4][17]. Group 3: Safety and Efficacy Data - The safety profile of the COMIRNATY vaccine has been evaluated, with common side effects including injection site pain, fatigue, and headache, which are generally mild to moderate and resolve within a few days [7][8]. - Observational data from vaccinated pregnant women during the second and third trimesters have not shown an increase in adverse pregnancy outcomes, indicating a favorable safety profile for the vaccine in this population [8]. Group 4: Market Readiness and Future Plans - Pfizer and BioNTech are proactively manufacturing the JN.1-adapted vaccine to ensure supply readiness ahead of the anticipated increase in demand during the fall and winter seasons [17][18]. - The companies are also initiating rolling applications with the U.S. FDA for approval of their Omicron KP.2-adapted monovalent COVID-19 vaccines, indicating ongoing efforts to adapt to evolving COVID-19 variants [18].

Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB1311, with antitumor activity and a manageable safety profile demonstrated by preliminary Phase 1/2 clinical data from patients with advanced or metastatic solid tumors1,2 With the Fast Track designation, the development of BNT324/DB-1311 can benefit from more frequent engagement with the U.S. Food and Drug Administration ("FDA") to support development and expedite regulatory review Prostate cancer is the second ...