BIONTECH 2024 Q2
Earnings Overview & AI Insights

Earnings Performance

Co-Founder and Chief Executive Officer? U?ur?ahin: "Our progress in the second quarter of 2024 was marked by significant execution across our oncology pipeline and our leading COVID-19 franchise. Jens and Ryan will then provide updates on our financial and corporate progress and the outlook for the remainder of the year. CEPI is committed up to $145 million to support us to establish mRNA vaccine clinical-clinical-scale manufacturing capabilities at our facility in Kigali, Rwanda. We continue circulation of SARS-CoV-2 leads to the ongoing evolution of novel variants of the virus, which we continue to monitor. We expect the FDA approval of our KP.2-adapted vaccine by mid-September, and we aim to deliver the first vaccine bolus to the people in the U.S. shortly thereafter. The other area of BioNTech's oncology pipeline is continuing to grow. We are accelerating the pace of pace of PIPelinewidepatient accruals compared to last quarter. We are recruiting six times as many patients per quarter to support enrollment into clinical trials you saw on the previous slide. The rich clinical pipeline and ambitious plans require execution capability which we are constantly building. The FixVac program is focused on treating patients with various forms of cancer. The company is evaluating three new vaccines, including BNT113, BNT116 and BNTT111. BNT111 is a uridine mRNA-LPX-based vaccine that encodes four melanoma-associated antigens. The BNT111-01 trial is based on the Lipo-glyglyMERIT Phase 1/2 trial in patients with advanced melanoma who had exhausted treatment options. The safety profile was generally mild and in line with expectations for those who were co-treated with checkpoint inhibitors. The BNT111 data is a proof of concept for our decade-long improved improved mRNA uticcancer vaccine technology. BNT122, our individualized mRNA cancer immunotherapy, is also a proof-of concept for BNT121. The company's BNT122-01 trial involves patients with stage 2-high-risk or stage 3 colorectal cancer. T-cell responses were sustained after two years of follow-up. BNT327 combines immunomodulatory IO compound with a novel combination. The company is building a pilot facility in Mainz, Germany, to support late-stage trials and potentially in-the-future commercialization. The anti-VEGF-A and the anti-PD-L1 are validated across many tumor types, and in some cases, as a combination. VEGF-A inhibits tumor angiogenesis, which leads to reduced tumor cell proliferation and survival. The PDL1 arm anchors this antibody to the tumor bed for efficient scavenging of VEGf-A. Cancer patients, particularly those with PD-L1 negative tumors, have few treatment options as they are not eligible for current anti-PD-1 therapies. We will soon start two global phase 2 dose-optimization studies to enable selection of a registrational dose for registrational trials in these particular indications. Second update from a safety run in cohort of our ongoing Phase 2 trials evaluating BNT113 dosed in a combination with pembrolizumab versus pemmerizumaab. We will also present updated results from our ongoing ongoing Phase 1 trial evaluating safety and efficacy of our new CAR-T cells in combination with Claudin 6-encoded mRNA. Research and development expenses were approximately 585 million euros for the second quarter of 2024, compared 373 million euros for the comparative prior-year period. Sales, general, and administrative expenses amounted to approximately 184 million euros in the second quarter of 2024, compared to 138 million euros in comparative prior-year period. The company expects to recognize the vast majority of its full-year revenues mostly in Q4. We expect to report a loss for the 2024 financial year, while continuing to invest in proprietary assets and technologies. The company's updated COVID-19 vaccine will be launched this fall's influenza season. The FDA has recommended the use of KP.2 as the preferred strain for the U.S. vaccine for the '24/25 season. The Comirnaty franchise is well-positioned to maintain its leading position globally in the continued fight against COVID-19. We'll continue to invest in our mRNA cancer vaccine platforms based on our belief that personalized mRNA cancer vaccines have potential to establish a new paradigm in cancer treatment. Have 10 potentially registrational trials active by the end of the year. We are still in the early stages, we are making progress in attracting talented professionals to join our commercial organization. We plan to hold our first Artificial Intelligence Innovation Innovation event via webcast on October 1, followed by our annual Innovation Series event on November 14.