BioNTech SE · NASDAQ:BNTX
BioNTech — Q4 2023 Earnings Presentation
35 slides from BioNTech's earnings presentation, Mar 20, 2024
Slide 1: 4th Quarter 2023 Financial Results & Corporate Update
4th Quarter 2023 Financial Results & Corporate Update March 20, 2024
Slide 2: This Slide Presentation Includes Forward-Looking Statements
This Slide Presentation Includes Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech's expected revenues and net profit
Slide 3: Agenda: Highlights, Pipeline, Financials, Strategic Outlook
1 4th Quarter and FY 2023 Highlights Ugur Sahin, Co-founder & Chief Executive Officer 2 Pipeline Update Özlem Türeci, Co-founder & Chief Medical Officer 3 Financial Results Jens Holstein, Chief Financial Officer 4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 4: 4th Quarter and FY 2023 Highlights
1 4th Quarter and FY 2023 Highlights Ugur Sahin, Founder & Chief Executive Officer
Slide 5: BioNTech's key objectives for the next phase
Our Vision: Harnessing the Power of the Immune System to Fight Human Disease Elevating success beyond our historical achievement BioNTech’s key objectives for the next phase Innovative precision Multi-product medicine pipeline immunotherapy pioneer targeting multiple Sustainable respiratory addressi
Slide 6: Developing an Innovative Pipeline Focused on Oncology and Infectious Disease
Developing an Innovative Pipeline Focused on Oncology and Infectious Disease Our pipeline Clinical and scientific execution in 2023 7 clinical trials started across platforms Ongoing mid- to late- stage trials: BNT316/ONC-3922 l BNT311/GEN10465 NSCLC Ph3: BNT323/DB-13031 l BNT316/ONC-3922 l BNT1163
Slide 7: Accelerating Development of our ADC and IO Programs Across Indications
Accelerating Development of our ADC and IO Programs Across Indications Patient recruitment metrics in 2022 & 2023 Goal for 2024 Aim to recruit patients with multiple >2,000 patients recruited for ADC & IO programs indications in 2024 Lung Cancer (NSCLC, SCLC) Breast Cancer (HR+ BC, TNBC) >650 >600 >
Slide 8: Corporate Execution in 2023 and Post-Period
Corporate Execution in 2023 and Post-Period Continued progress towards building a multi-product, AI-powered, patient-centric company embedded in the biotech ecosystem Acquired InstaDeep In-licensed 6 new Strategic alliance with Autolus clinical stage candidates Integrating capabilities in super- Add
Slide 9: Aiming for Meaningful Impact with BNT211 in Patients with CLDN6+ Tumors
Aiming for Meaningful Impact with BNT211 in Patients with CLDN6+ Tumors Antitumor activity seen in multiple CLDN6+ tumor types Addressable patient population Haanen J. et al. Presented at ESMO 2023. Abstract #LBA35. 60 Best response and change in target sum (all DLs ± CLDN6 CARVac ) 30 Total address
Slide 10: Towards a Potentially Curative Approach to Cancer: Differentiated Combinations
Towards a Potentially Curative Approach to Cancer: Differentiated Combinations Immunomodulators • Our modality agnostic armamentarium aims to Immunomodulators focus on the most relevant and crucial IO pathways Novel checkpoint inhibitors, • Targeting different but complementary players in cytokines,
Slide 11: Pipeline Update
Pipeline Update Özlem Türeci, Co-Founder & Chief Medical Officer
Slide 12: Our Multi-Platform Immuno-Oncology Pipeline Today
Our Multi-Platform Immuno-Oncology Pipeline Today Phase 1 Phase 1/2 Phase 2 Phase 3 BNT116 BNT142 (CD3xCLDN6) BNT1112 BNT316/ONC-392 (gotistobart)4 (CTLA-4) NEW Adv. NSCLC Multiple CLDN6-pos. adv. solid tumors aPD(L)1-R/R melanoma, + cemiplimab anti-PD-1/PD-L1 experienced NSCLC Autogene cevumeran/BN
Slide 13: Making Progress Towards Submissions for Regulatory Approvals in Oncology
Making Progress Towards Submissions for Regulatory Approvals in Oncology Select ongoing mid- to late-stage trials Mid- to late-stage trials planned in 2024 & beyond BNT316/ONC-392 (gotistobart)1 Phase Phase 3 BNT323/DB-13032 3 anti-PD-1/PD-L1-experienced NSCLC BNT323/DB-13032 Phase Phase HR+, HER2-l
Slide 14: ADC Portfolio Constructed with Thoughtful Considerations
ADC Portfolio Constructed with Thoughtful Considerations Expression level by indication1 Advanced asset on path to registration HER2+ • BNT323/DB-13032 in multiple pivotal Target NSCLC SCLC HR+ BC TNBC CRC Gastric Ovarian PDAC HNSCC Prostate BC studies HER2 TROP2 B7-H3 Unique indication selection st
Slide 15: BNT323/DB-1303: A HER2 ADC with a Potentially Differentiated Profile
BNT323/DB-13031: A HER2 ADC with a Potentially Differentiated Profile BNT323/DB-1303 is a Mode of action Preclinical Data 3rd generation ADC Lin S. et al. Abstract #252. Presented at EORTC- NCI-AACR in 2022 & data on file. • Superior in vitro plasma stability in • A humanized anti-HER2 Targeted Cyto
Slide 16: First-in-Human Trial with BNT323/DB-1303 in Advanced HER2-Expressing Solid Tumors
First-in-Human Trial with BNT323/DB-13031 in Patients with Advanced HER2-Expressing Solid Tumors Phase 1/2a trial design (NCT05150691), multicenter, non-randomized, open-label Moore K. et al. Presented at ASCO 2023. Abstract #3023. Inclusion criteria Part 1: Dose escalation (n=88 patients) Part 2a:
Slide 17: First Clinical Data for BNT323/DB-1303 in HER2-Expressing Breast Cancer
First Clinical Data for BNT323/DB-13031 Demonstrated Antitumor Activity in Heavily Pretreated HER2-Expressing Breast Cancer Patients Phase 1/2a FIH study (NCT05150691): Clinical activity and safety Adapted from Moore K. et al. Presented at ASCO 2023. Abstract #3023. Anti-tumor activity in heavily pr
Slide 18: BNT323/DB-1303 May Establish a New SoC for HR+/HER2-Low Breast Cancer
BNT323/DB-13031 May Have Potential to Establish a New SoC for Chemotherapy-Naïve, HR+/HER2-Low Patients with Breast Cancer Total diagnosed breast cancer patients in U.S., UK, EU4 and Japan: ~708K2-5 HR+/HER2-negative (70%6 of total breast cancer patients) HR+/HER2-low (60%67of HR+/HER2-neg breast ca
Slide 19: Data Supporting Path to Potential Registration in HER2-Expressing Endometrial Cancer
Data Supporting Efficacy of BNT323/DB-13031 Facilitates Path to a Potential Registration in HER2-Expressing Endometrial Cancer Patients Phase 1/2a FIH study (NCT05150691): Clinical Efficacy Moore K. et al. Presented at ESGO 2023. Abstract # 430 • HER2 tumor expression of IHC 1, 2 and 3+: 31%, 41% an
Slide 20: BNT323/DB-1303 Potential New SoC for HER2-Expressing Endometrial Cancer
BNT323/DB-13031 Offers the Potential to Establish a New SoC for Patients with HER2-Expressing Endometrial Cancer Total diagnosed endometrial cancer patients in US, UK, EU4 and Japan: ~130K2 Relevant patient population: Advanced/unresectable, recurrent Stage IV (~50K) Potential future treatment algor
Slide 21: First Wave of Potential Oncology Launches From 2026 Onwards
First Wave of Potential Oncology Launches From 2026 Onwards Could Include: Product BNT323/ BNT316/ BNT327/ BNT211 BNT311/ Diverse candidate DB-13031 ONC-392 PM80023 GEN1046 MoAs (gotistobart)2 (acasunlimab)4 Validated & new targets Mix of partnered and proprietary Target HER2 CTLA-4 VEGF-A x CLDN6 P
Slide 22: Financial Results
3 Financial Results Jens Holstein, Chief Financial Officer
Slide 23: FY 2023 Key Financial Highlights
FY 2023 Key Financial Highlights1 Total revenues Profit before tax € 3.8 bn € 1.2 bn Diluted EPS Total cash plus security investments2 € 3.83 € 17.7 bn 1. Financial information is prepared and presented in Euros and numbers are rounded to millions and billions of Euros in accordance with standard co
Slide 24: FY 2023 Revenues and Cash plus Security Dynamics
FY 2023 Revenues and Cash plus Security Dynamics FY 2023 revenues reduced by significant write-downs Cash plus security investments grew in 20233 (in billions €)1 (in billions €)1 4.7 +27% 17.72 0.9 3.8 13.9 FY 2023 revenues FY 2023 write-downs FY 2023 revenues YE 2022 YE 2023 without reflection of
Slide 25: Q4 and FY 2023 Financial Results
Q4 and FY 2023 Financial Results Three months ended December 31 Years ended December 31 (in millions €, except per share data)1 2023 2022 2023 2022 Commercial revenues2 1,478.9 4,271.3 3,815.5 17,194.6 Research & development revenues 0.1 7.0 3.5 116.0 Total revenues 1,479.0 4,278.3 3,819.0 17,310.6
Slide 26: FY 2023 Guidance vs. Actuals
FY 2023 Guidance vs. Actuals1 Updated Guidance FY 2023 Nov 2023 Actuals FY 2023 BioNTech COVID-19 vaccine revenues ~ €4 bn €3.8 bn COVID-19 vaccine revenues R&D expenses2 €1,800 – 2,000 m €1,783 m FY 2023 SG&A expenses3 €600 – 650 m €558 m expenses and capex Capital expenditure for operating activit
Slide 27: 2024 Financial Year Guidance
2024 Financial Year Guidance1 FY 2024 Guidance FY 2024 Total revenues €2,500 – €3,100 m revenues R&D expenses2 €2,400 – €2,600 m FY 2024 expenses, operating income and SG&A expenses3 €700 – €800 m capex4 Capital expenditure for operating activities €400 – €500 m • Vaccination rates and price levels
Slide 28: Profitable COVID-19 Vaccine Business supports Investment in Growth Drivers
Profitable COVID-19 Vaccine Business supports Investment in Growth Drivers COVID-19 Vaccine Business – major value contributor Innovative Oncology Pipeline – potential future value driver FY 2023 • Aiming for 10+ potentially registrational trials ongoing • Revenue of €3.8 bn by the end of 2024 • Gro
Slide 29: Strategic Outlook
4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 30: Strategic Vision for 2030
Strategic Vision for 2030 Key value Cash Respiratory Oncology Infectious drivers position vaccine franchise pipeline diseases pipeline YE 2023 €17.7 bn cash1 Market-leading Expanding Early-stage pipeline COVID-19 vaccine late-stage pipeline 10+ potentially registrational trials 5 active non-COVID ID
Slide 31: Investing in Our Oncology Growth Through 2030
Investing in Our Oncology Growth Through 2030 Mid- and late-stage programs 2024 Impact BNT323/DB-13031 Aiming for 10+ Yearly oncology BNT316/ONC-392 (gotistobart)2 potentially registrational launches planned BNT311/GEN1046 (acasunlimab)3 trials by end of 2024 from 2026 onwards BNT327/PM80024 Multipl
Slide 32: Save the date
Save the date Annual General Meeting May 17, 2024 Innovation Series: Digital & AI October 1, 2024 Innovation Series November 14, 2024
Slide 33: Thank you
—_ Thank you BIONT=Cr
Slide 34: Appendix
Appendix BIONT=CrH
Slide 35: Advancing our Pipeline: Select Data Milestones in 2024
Advancing our Pipeline: Select Data Milestones in 2024 Program Indication Targeted Milestone BNT311/GEN1046 (acasunlimab)1 R/R met. NSCLC, +/- pembrolizumab Phase 2 data BNT312/GEN10421 Multiple solid tumors Ph1/2 expansion cohort data BNT316/ONC-392 (gotistobart)2 Multiple solid tumors Ph1/2 expans