On January 9, 2024 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported its full year 2024 revenue guidance as part of its outlined 2024 strategic priorities today at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, BioNTech, JAN 9, 2024, View Source [SID1234639147]).

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"At BioNTech, we are making important strides towards building a global immunotherapy company. In 2023, we continued our vaccine leadership in the fight against COVID-19 and significantly expanded our mid- and late-stage oncology pipeline. Currently, late-stage trials are ongoing in multiple oncology indications, and we plan to have ten or more potentially registrational trials in our pipeline by the end of 2024," said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. "This year will be a year of significant execution at BioNTech as we continue to expand and develop our innovative pipeline towards our first oncology launches expected from 2026 onwards."

Prof. Ugur Sahin, M.D., will present a corporate overview and update at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024, at 6:00 p.m. CET/ 12:00 p.m. ET. A live webcast of the presentation will be available on the "Events & Presentations" page in the Investor Relations section on the Company’s website. The replay of the webcast will be archived on the Company’s website for 30 days following the conference.

2024-2026 Financial Framework

BioNTech projects total company revenues of approximately €3 billion for the financial year 2024, mainly driven by the COVID-19 vaccine franchise which is expected to remain profitable given the Company’s cost sharing structure with its partner Pfizer Inc. ("Pfizer"). The Company plans to provide detailed full year 2024 financial guidance during its Full Year and Fourth Quarter 2023 Financial Results call on Wednesday, March 20, 2024.

BioNTech ended 2023 with approximately €17.5 billion (unaudited) in cash, cash equivalents and security investments. The Company plans to maintain a strong financial position and generate significant interest income in 2024. BioNTech expects to grow its topline again in 2025. In the outer years, the Company projects revenues derived from both oncology and respiratory combination vaccine launches, which are subject to successful development and regulatory approval.

As a science and innovation driven company, BioNTech will continue to focus investments on R&D and scaling the business for commercial readiness in oncology in multiple countries by the end of 2025 while continuing to be cost disciplined.

Summary of Selected Pipeline Updates and Expected Milestones

COVID-19 & Other Infectious Diseases

BioNTech’s infectious disease portfolio seeks to address four key areas of high medical need: respiratory viruses, latent viruses, global health pathogens, and antimicrobials. The Company has established a broad early-stage infectious disease vaccine candidate pipeline containing seven clinical programs leveraging its mRNA technology.

BNT162b2 + BNT161 is an mRNA-based combination vaccine program against COVID-19 and influenza being developed in collaboration with Pfizer. Topline data from the Phase 1/2 trial (NCT05596734) demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains and that the safety profile of the candidates was consistent with the companies’ COVID-19 vaccine.

Oncology

In 2023, BioNTech made significant progress in demonstrating the potential of its oncology programs as part of its in-house discovery and development efforts and added six new clinical assets, including next generation antibody-drug conjugate (ADC) candidates and antibody programs, to the Company’s oncology pipeline through internal and collaborative efforts. The Company’s pipeline continued to mature in 2023 with various programs advancing towards later stages of development. BioNTech’s pipeline currently contains 11 ongoing Phase 2 and 3 trials.

Selected later-stage programs:

BNT323/DB-1303 is an HER2-targeted antibody-drug conjugate candidate being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"). First-in-human data from an ongoing Phase 1/2 trial (NCT05150691) demonstrated anti-tumor activity in patients with heavily pretreated HER2-expressing solid tumors. In December 2023, the U.S. Food and Drug Administration ("FDA") granted Breakthrough Designation for BNT323/DB-1303 for the treatment of advanced endometrial cancer in patients who progressed on or after treatment with immune checkpoint inhibitors. A pivotal Phase 3 trial (NCT06018337) in patients with Hormone Receptor-positive ("HR+") and HER2-low metastatic breast cancer that have progressed on hormone and/or cyclin-dependent kinase 4/6 ("CDK4/6") therapy is planned. Additional potentially registrational trials are planned to be initiated in 2024.

BNT316/ONC-392 (gotistobart) is a next-generation anti-CTLA-4 monoclonal antibody candidate jointly developed by BioNTech and OncoC4, Inc. ("OncoC4"). A pivotal Phase 3 trial (NCT05671510) evaluating BNT316/ONC-392 (gotistobart) in patients with immunotherapy-experienced non-small cell lung cancer (NSCLC) is ongoing.

BNT327/PM8002 (PD-L1xVEGF) is an anti-VEGF-A antibody candidate fused to a humanized anti-PD-L1 VHH being developed in collaboration with Biotheus Inc. ("Biotheus"). BNT327/PM8002 is currently being evaluated in several Phase 2/3 studies in China to assess the efficacy and safety of the candidate as a monotherapy or in combination with chemotherapy in various indications. Trial data are planned to be presented this year at a medical conference, and an Investigational New Drug application has been accepted by the FDA for further studies in the U.S. A potentially registrational trial is planned in 2024.

BNT311/GEN1046 (acasunlimab) is a potential first-in-class bispecific antibody candidate combining PD-L1 checkpoint inhibition with 4-1BB costimulatory activation being developed in collaboration with Genmab S/A ("Genmab"). Based on emerging clinical data, the companies have planned engagement with health authorities on the design of a Phase 3 trial for BNT311/GEN1046 (acasunlimab) in second line NSCLC. The companies intend to share the data on which this decision was based at a medical conference in 2024.

BNT312/GEN1042 is a potential first-in-class bispecific antibody candidate designed to induce conditional immune activation by crosslinking CD40 and 4-1BB positive cells, also being developed in collaboration with Genmab. Data required to determine next steps for this program are planned to be shared at a medical conference in 2024.

BNT122 (autogene cevumeran) is an mRNA cancer vaccine candidate based on an individualized neoantigen-specific immunotherapy (iNeST) approach being developed in collaboration with Genentech Inc. ("Genentech"), a member of the Roche Group. In October 2023, BioNTech announced the initiation of IMCODE003, a Phase 2 trial (NCT05968326) evaluating the efficacy and safety of autogene cevumeran in combination with the anti-PD-L1 immune checkpoint inhibitor atezolizumab and standard of care chemotherapy in patients with resected pancreatic ductal adenocarcinoma. This is the third indication for which autogene cevumeran is being evaluated in a Phase 2 trial, alongside other ongoing studies in first-line melanoma and adjuvant colorectal cancer. An additional Phase 2 trial is planned to be initiated as early as late 2024.

BNT211 consists of two investigational medicinal products: a CAR-T cell product candidate targeting Claudin-6 (CLDN6)-positive solid tumors, in combination with a CAR-T cell-amplifying RNA vaccine (CARVac) encoding CLDN6. BioNTech plans to initiate a pivotal Phase 2 trial in relapsed/refractory germ cell tumors in 2024.

In 2024, BioNTech intends to accelerate the development of its portfolio of next-generation investigational medicines both as monotherapies and in combination with immunotherapy agents and other targeted therapies across a wide range of tumor types. BioNTech believes it is well positioned to have ten or more potentially registrational trials in areas of unmet medical need by the end of 2024 in advance of launching its first oncology products from 2026 onwards.

Upcoming Investor and Analyst Events

Full Year and Fourth Quarter 2023 Financial Results: March 20, 2024
Annual General Meeting: May 17, 2024