BioNTech SE

Good morning and afternoon. Thank you for joining us today for BioNTech's third quarter 2023 earnings call. As a reminder, the slides that accompany this call and the press release issued this morning can be found in the investor section of our website. On the next slide, you can see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filing made with the U.S. Securities and Exchange Commission. Forward-looking statements on the call are subject to substantial risks and uncertainties. Seek only of the call's original date, and we undertake no obligation to update or revise any of the statements. On slide three, you can find the agenda for today's call. Today, I'm joined by the following members of BioNTech's management team. Our CEO and co-founder, Ugur Zahin, Özlem Türeci, our chief medical officer and co-founder, Jens Holstein, our chief financial officer, and Ryan Richardson, our chief strategy officer. I would like to turn the call over to Uwe Sahin.

Thank you, Victoria. A warm welcome to all those joining us today. I will summarize our third quarter highlights before turning to my colleagues who will provide further details. Slide five. Let me start by providing an overview of our strategic priorities and latest achievements. This quarter, we continue to build on our global COVID-19 vaccine leadership with first-to-market Omicron XBV1.5 adapted vaccine launches across multiple regions worldwide. I thank our team and collaborators for their tireless efforts to make this accomplishment possible again in such a short period of time. Our COVID-19 Influenza Combination Program, funded in partnership with Pfizer, leveraging our proprietary mRNA technology, has also reported positive top-line results. The Phase 1-2 study evaluating the safety, tolerability, and immunogenicity of co-administered mRNA-based vaccine candidates for COVID-19 and influenza among healthy adults 18 to 64 years of age, when compared to a licensed influenza vaccine, demonstrated robust immune responses to Influenza A, Influenza B, and SARS-CoV-2 strains, as well as a safety profile consistent with the safety profile of the company's COVID-19 vaccine. A pivotal phase three study will be initiated in the coming months. Our second strategic priority is to advance our oncology platforms by initiating multiple trials with registrational potential. Jointly with our partner, Duality Bio, we are initiating a pivotal phase three trial to evaluate our next generation antibody-conjugated BNT323 in patients with hormone receptor-positive to low breast cancer who progress on previous standard of care but are chemotherapy-naive. Furthermore, during this quarter, we and our respective collaboration partners published original scientific papers and presented new clinical data across several programs at international scientific congresses, including ESMO and CITSE, that will inform our development strategies and next steps for these programs. Based on the successful results, we have expanded existing collaborations and made new deals with specialized developers which adds to our proprietary toolkit of technologies and strengthen our therapeutic product candidate portfolio. This covers the in-licensing of our free targeted antibody drug conjugate from MediLink Therapeutics, and as announced today, our plan to bring forward an anti-VGF, anti-PD-L1 bispecific antibody in collaboration with our partner BioFeel. Our first strategy priority is to initiate and accelerate clinical programs that target infectious diseases of unmet medical need. In the third quarter, we initiated our first in human trial in infectious disease this year, a program aimed at advancing mRNA-based vaccine candidates for the prevention of mpox, run in partnership with the Coalition for Epidemic Preparedness Innovation. In summary, we continued our focused execution against our strategic priorities in the third quarter and look forward to additional progress in all three of these areas for the remainder of the year and into 2024. We will share more detail on our oncology as well infectious disease programs at our Innovation Series Day in Boston tomorrow, an event that I invite you all to attend in person or online. Slide six, focusing on our marketed COVID-19 vaccine community. We continue to build on our global COVID-19 vaccine leadership, the first to market Omicron XBV1.5 adapted vaccine launches. This was preceded by a robust and successful regulatory process. In late August, the European Medicines Agency recommended full marketing authorization for our monovalent XBV1.5 adapted vaccine. This was followed in September by the US Food and Drug Administration authorizing the adapted vaccine for individuals aged six months to 11 years under emergency use authorization and for those aged 12 and above. The vaccines have been approved under supplemental biologics license applications. Other national health regulators across the globe, including the UK, Japan, Canada, and South Korea, have also approved our monovalent adaptive vaccine. Within two months, we went from the first regulatory recommendations for an XB1.5 adaptive vaccine to our first shipment of the respective vaccine. The ability to execute at such speed was enabled by our continued surveillance and analysis of variants of concern, the strength of our mRNA technology which allows for scalable production, rapid manufacturing and adaptation, and our expertise at navigating the evolving regulatory landscape on a global scale. Historically, we have seen an increase in COVID-19 hospitalizations in the winter in line with other common respiratory diseases. On slide seven, you can see independent on former projections across scenarios assuming different vaccination recommendations and immune escape levels. Based on this, it is expected that weekly hospitalizations are likely to increase this winter and have a healthcare impact similar to last year. COVID-19 burden is currently lower than in previous years. However, the absolute number of hospitalizations and deaths is still high in certain regions with thousands of hospitalizations and hundreds of deaths each week. The emergence of new variants coupled with the waning of both vaccine and infection-induced immunity indicates that susceptibility to infection remains a concern and may increase over time. Moreover, the data shown here suggests that providing simple, stable recommendations for updated doses could contribute to improved vaccine coverage over time, mitigating the risks associated with evolving COVID-19 variants. As shown on slide eight, long COVID has a significant societal and healthcare system impact, The studies indicating that 10 to 20% of SARS-CoV-2 infected individuals may develop symptoms recognized as long COVID. It is estimated that 36 million people across Europe may have experienced complications arising from COVID-19 weeks after infection commonly defined as long COVID from the start of the pandemic to date. Studies show that mRNA vaccination has a significant impact in reducing the development of long COVID by 10 to 45%, depending on the criteria used to define symptoms. The protective effect of mRNA vaccination is largely attributed to its ability to reduce susceptibility to infection. We continue to look closely at the role of mRNA vaccination in addressing the unmet need of long COVID. Slide nine. Studies have demonstrated that natural immunity acquired by SARS-CoV-2 infection is variable across individuals and the protection it offers over time. Vaccination can restore and enhance infection-acquired immune protection and further reduce the risk of reinfection. The risk of severe COVID-19 disease remains high in vulnerable populations, and that vaccination serves to not only reduce the risk, but can also mitigate the risk of long COVID. And preclinical data demonstrate that vaccination with XBB1 descendant lineage containing candidate elicits higher neutralizing antibodies to currently circulating variants of concern compared to the responses elicited by previously approved COVID-19 vaccines. Given all this and our current understanding of COVID-19 seasonality and its burden on healthcare systems during autumn and winter season, we anticipate the need for annual adaptive vaccines to be a long-term feature of COVID-19 vaccination practices. With that, I would like to thank you all for your confidence in our success and your continued support. I will now turn the call over to Esla.

Thank you, Ugo. Glad to be speaking with everyone. Today we will provide a high-level pipeline update. We will delve into the more advanced programs in greater detail at our Innovation Series Day event tomorrow. Starting with an overview of our infectious disease pipeline on slide 11. In addition to our marketed product, Comirnaty, we continue to pursue our multi-prompt innovation strategy to improve upon our vaccine with next generation approaches aimed at generating broader and more durable immunity. This includes our stabilized spike vaccine approach being studied in the phase two trial and our T-cell enhancing vaccine candidate in an ongoing phase one trial. We believe that our COVID-19 vaccine has the potential to be combined with a seasonal flu vaccine. Across many parts of the world, people are currently receiving the Omicron XBB adapted vaccine boosters at the same time as their flu shots. A combination product has the potential to provide seasonal protection from both viruses with a single shot. We are working together with our partner Pfizer to develop an influenza combination vaccine which leverages our mRNA technology. We recently reported Phase 1-2 results where our combination candidate showed robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains, as well as a safety profile consistent with a safety profile of companies COVID-19 vaccine which met the criteria for advancement to a phase three trial. In addition to the previously mentioned COVID-19 and influenza vaccine programs, we started multiple first in human trials of our mRNA vaccine candidates in the last year that addressed shingles, HSV, TB, and mpox. On slide 12, as expected, SARS-CoV-2 continues to evolve. The Omicron XBB sublineages currently account for the majority of COVID-19 cases globally, including the XBB descendant EG51, whose dominance is growing. Slide 13. We and our partner Pfizer tested for potential effectiveness of an Omicron XBB15-adapted monovalent vaccine as a primary series and booster in preclinical models. You can see here the neutralizing antibody response in mice immunized with our Omicron BA45 adapted bivalent vaccine as a booster after two doses of the original BNT162b2 vaccine. One group of mice, again, received the BA45 adapted bivalent COVID-19 vaccine as a fourth dose, and the other group received the new XBB1.5 adapted monovalent COVID-19 vaccine as a fourth dose. You can see a four to five-fold increase of neutralization of several XBB-related variants when dose four is the XBB1.5 adapted monovalent vaccine as compared to last season's BA.4.5 adapted vaccine. These preclinical data indicate that an XPB15 variant-adapted monovalent vaccine in the pre-vaccinated setting has the potential to induce broad cross-neutralizing antibody titers against multiple XPB sublineages. We can also see an increase in geometric mean titers of neutralizing antibodies across XPB lineages including EG5.1 and BA286 when compared to the previous bivalent BA45 vaccine comparator arm. Slide 14 shows the design of our ongoing phase two free clinical study, testing the safety, tolerability, and immunogenicity of our Omicron XBB1.5 adapted monovalent vaccine in 700 vaccine naive and vaccine experienced participants. While data from this study will be reported in 2024, there's already clinical real-world data shown on slide 15 demonstrating that our XBB1.5 adapted vaccine elicited significantly higher neutralizing antibody responses against XBB1.5, XBB2.3, EG5.1, and BA286 compared to pre-vaccination levels. Moving now to our oncology pipeline on slide 16, which is grounded in our multi-modality toolbox and is advancing through focused execution. We now have one phase three study ongoing and a second phase three expected to dose its first patient soon. Gotistobat, our anti-CTLA-4 monoclonal antibody, which we believe offers a differentiated safety profile. A phase three clinical trial evaluating its efficacy and safety as monotherapy in metastatic non-small cell lung cancer patients who have progressed on previous IO therapy has started in June this year and will enroll 600 patients. BNT323, our anti-HER2 antibody drug conjugate, also being studied in a phase three clinical trial to assessing its efficacy versus investigator's choice of chemotherapy in patients with hormone receptor positive her to low chemotherapy naive breast cancer patients whose disease has progressed on at least two lines of prior endocrine therapy or within six months of first line endocrine therapy plus CDK fog inhibitor. We've also recently initiated two new phase two trials, one in partnership with Genentech is evaluating our individualized cancer vaccine candidate, BNT122, in the adjuvant setting for patients with pancreatic cancer. The other, in partnership with GenMaps, is evaluating our BNT311 bispecific conditionally PD-L141BB agonistic antibody as a second-line treatment for patients with endometrial cancer. Also, as part of our collaboration with GENMAP BNT314, a bispecific antibody designed to boost anti-tumor immune responses through APCOM-dependent 4.1BB agonistic activity is ready to move from preclinical to phase 1 clinical testing with the first patient dose expected in the next few months. Within our biospecific portfolio, I'm excited about our expanded collaboration with Biofears announced today. We've partnered to develop and commercialize PM8002, a biospecific antibody candidate targeting PD-L1 and VEGF-A in various cancer indications. PM8002 is currently being tested in a phase two free study to evaluate the efficacy and safety of a candidate at monotherapy or in combination with chemotherapy in patients with non-small cell lung cancer. PM8002 may lead to reduced systemic toxicity by enriching anti-VEGF activity in the tumor microenvironment. Now, moving on to our antibody drug conjugate portfolio. During the quarter, one of our Andravity's ADCs BNT324 entered a Phase 1-2 basket trial. Furthermore, on the ADC front, I would like to note our latest addition, YL202, a candidate being developed in partnership with MediLink. We continue to broaden our access to ADCs because we believe this technology has the potential to replace highly toxic chemotherapy regimens to become a new commoditized combination backbone of cancer treatment. In summary, we can see a diversified clinical oncology pipeline and solid tumor indications of high unmet medical need and more than 30 clinical studies. On slide 17, I would like to highlight five across our multiple platforms that have disclosed clinical data in recent medical conferences this autumn. In September, clinical data from the ongoing Phase 1-2 clinical trial evaluating BNT3-23 in patients with advanced and unresectable recurrent or metastatic HER2-expressing solid tumors were presented at the ESGO annual meeting. BNT3-23 was shown to have a manageable safety profile and no new safety signals were observed. It also demonstrated promising anti-tumor activity in patients with advanced recurrent or metastatic HER2 expressing endometrial cancer with an objective response rate confirmed and unconfirmed of 58.8% and disease control rate of 94.1%. Data at ESMO, we presented alongside our partner, Duality Bio, clinical data from the ongoing Phase 1-2 trial, evaluating our TROP2-targeted ADC candidates in patients with advanced solid tumors. The data suggested a manageable safety profile at lower dose levels and encouraging efficacy signals were observed in non-small cell lung cancer patients with unconfirmed objective response rate of 46.2%, in 6 out of 13 evaluable patients, and an unconfirmed DCR of 92.3% in 12 out of 13 patients. We also reported data from the ongoing Phase 1-2 clinical trial with BNT211, detailing the new dose escalation of Chloridin-6 CAR T cells with and without a Chloridin-6 encoding mRNA vaccine for the treatment of Chloridin-6 positive relapsed refractory solid tumors using an automated manufacturing process. BNT211 demonstrated an encouraging anti-tumor activity, and in patients treated at a higher dose level, the addition of CARVAC improved CAR T-cell persistence. The rate of treatment-dependent adverse events was dose-dependent. After determination of a recommended Phase II dose, BioNTech plans to initiate a pivotal trial in germ cell tumors. Also at ESMO, we presented initial data from our first in human phase one dose escalation trial, evaluating BNT221. Our autologous, fully personalized T-cell therapy directed against selected sets of individualized neoantigens. Using our proprietary neostim technology on the patient's peripheral blood cells, we expand memory T-cells and induce naive T-cells with the aim of generating the strong polyclonal immune response to overcome antigen escape. The initial results showed a manageable safety profile and tumor regression in several patients with anti-PD-1 and anti-CTLA-4 pre-treated advanced or metastatic melanoma. This past weekend, at WITC, clinical data was shown from the ongoing Phase I clinical trials evaluating BND1-16. our official mRNA-based cancer vaccine candidate for non-small cell lung cancer patients. The trial evaluates BNT116 alone and in combination with Simiplimab or docetaxel across multiple settings. BNT116 was generally well tolerated with an expected safety profile as monotherapy and in combination with Simiplimab. In heavily pretreated non-small cell lung cancer patients, Treatment with BNT116 with an optional addition of Semipremab from cycle 3 onwards showed early clinical activity. These updates show the momentum across our cancer pipeline. This year and next year, we plan to advance our key programs into late-stage development, including multiple programs toward the pivotal stage with the aim to deliver the next generation of oncology medicine. And with that, I now pass the presentation to our CFO, Jens Holstein.