BioNTech SE · NASDAQ:BNTX
BioNTech — Q3 2023 Earnings Presentation
29 slides from BioNTech's earnings presentation, Nov 6, 2023
Slide 1: 3rd Quarter 2023 Financial Results & Corporate Update
3rd Quarter 2023 Financial Results & Corporate Update November 6, 2023
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: 3rd Quarter 2023 Highlights
1 3rd Quarter 2023 Highlights Ugur Sahin, Chief Executive Officer 2 Pipeline Update Özlem Türeci, Chief Medical Officer 3 Financial Results Jens Holstein, Chief Financial Officer 4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 4: 3rd Quarter 2023 Highlights
1 3rd Quarter 2023 Highlights Ugur Sahin, Chief Executive Officer
Slide 5: Strategic Priorities and Achievements in Q3 2023 and Post Period
Strategic Priorities and Achievements in Q3 2023 and Post Period COVID-19 franchise1 Immuno-oncology Infectious diseases 2023 Strategic Priorities Sustain leadership in COVID-19 vaccines Advance oncology pipeline across multiple solid tumors Initiate and accelerate clinical programs for diseases of
Slide 6: COMIRNATY Q3 Highlights
COMIRNATY1 Q3 Highlights Strong Global Rapid Regulatory Distribution Advancement First-to-market Omicron XBB.1.5-adapted EU: EMA Full Marketing Authorization for ages monovalent vaccine 6 months and older2 Distributed to over 40 countries and US: FDA sBLA for individuals 12+ years and EUA regions wo
Slide 7: Hospitalizations Likely to Increase this Winter and Stay Within Last Year's Range
Hospitalizations Likely to Increase this Winter and Stay Within Last Year’s Range1 80k No booster High threshold2 60k 40k Medium threshold3 20k 0 80k Incident Hospitalization 65+ booster 60k High threshold2 40k Medium threshold3 20k 0 80k 60k High threshold2 40k All booster Medium threshold3 20k 0 J
Slide 8: Statistically Significant Reduction in Developing Long COVID after mRNA Vaccination
Statistically Significant Reduction in Developing Long COVID after mRNA Vaccination Prevalence of ongoing symptoms lasting at least Probability of developing long COVID in 3 months after COVID-19 infection vaccinated vs non-vaccinated individuals by age, regardless of COVID status, U.S. Inverse prob
Slide 9: Long-Term Need for Annually Adapted Vaccines Anticipated
Long-Term Need for Annually Adapted Vaccines Anticipated Continuous evolution Risk remains high Ongoing antigenic evolution For severe COVID-19 in of SARS-CoV-21,2 vulnerable populations3 Annual and/or SEASONAL Long-term health VACCINATION with variant-adapted consequences vaccines expected for the
Slide 10: Pipeline Update
Pipeline Update Özlem Türeci, Chief Medical Officer
Slide 11: Infectious Disease Pipeline: Achievements in Q3 2023 and Post Period
Infectious Disease Pipeline: Achievements in Q3 2023 and Post Period Indication Product Candidate Phase 1 Phase 1/2 Phase 2 Phase 3 Commercial COMIRNATY® BNT162b2 Original/Omicron BA.4/5-adapted bivalent BNT162b2 Original/Omicron BA.1-adapted bivalent COVID-191 BNT162b2 Omicron XBB.1.5. Launched ✓ I
Slide 12: XBB Sublineages Continue to Dominate the Epidemiologic Landscape
XBB Sublineages Continue to Dominate the Epidemiologic Landscape Despite the Emergence of New Lineages Growing dominance of the XBB-descendent EG.5.1 Percentage of sequences submitted to GISAID 100% 90% In the US, EG.5 is one of the three 80% EG.5 most prevalent 70% XBB.1.16 variants and is a XBB.1.
Slide 13: Monovalent XBB.1.5 Adapted Vaccine Elicits Higher nAbs Responses against VoCs
Monovalent XBB.1.5 Adapted Vaccine Elicits Higher nAbs Responses against VoCs Compared to the Bivalent BA.4/5 Adapted Vaccine in Preclinical Models Experimental design (mice) XBB.1.5-adapted monovalent vaccine elicits potent neutralization against various sublineages: XBB.1.5, EG.5.1, BA.2.86, XBB.1
Slide 14: Phase 2/3 Clinical Trial Evaluating XBB.1.5 Monovalent COVID-19 Vaccine
Phase 2/3 Clinical Trial Evaluating XBB.1.5 Monovalent COVID-19 Vaccine BNT162b2 (OmiXBB.1.5) (NCT05997290) Phase 2/3, open label, controlled safety and efficacy study Inclusion criteria Healthy participants, 12 years of age or older BNT162b2 (OmiXBB.1.5) Cohort A: 3 prior doses of a US- N = 700 s
Slide 15: Clinical Study Demonstrated Monovalent XBB.1.5 BNT162b2 Effectively Neutralizes EG.5.1, XBB.1.5 and BA.2.86
Clinical Study Demonstrated Monovalent XBB.1.5 BNT162b2 Effectively Neutralizes EG.5.1, XBB.1.5 and BA.2.86 in Adults EG.5.1 XBB.1.5 XBB.1.16 XBB.2.3 BA.2.86 Response rate [%]: 43 98 55 100 53 98 49 98 77 100 Geometric mean titer: 20 691 27 967 28 906 22 1031 70 993 Clinical Study Median fold change
Slide 16: Oncology Pipeline: Achievements in Q3 2023 and Post Period Events
Oncology Pipeline: Achievements in Q3 2023 and Post Period Events Phase 1 Phase 1/2 Phase 2 Phase 3 BNT116 BNT1122 BNT1112 BNT316/ONC-392 (gotistobart)4 (CTLA-4) Adv. NSCLC mCRPC & high risk LPC aPD(L)1-R/R melanoma, + cemiplimab anti-PD-1/PD-L1 experienced NSCLC Autogene cevumeran/BNT1221 BNT142 BN
Slide 17: Multiple Clinical Data Readouts at Major Medical Conferences in 2H 2023
Multiple Clinical Data Readouts at Major Medical Conferences in 2H 2023 Cancer vaccine Platform ADC ADC CAR T-cell therapy NEO-STIM Cell therapy (FixVac) BNT323/DB-13031 BNT325/DB-13051 BNT211 BNT221 BNT116 Program Multiple Solid Tumors Multiple Solid Tumors CLDN6+ Solid Tumors r/r met Melanoma Adva
Slide 18: Financial Results
3 Financial Results Jens Holstein, Chief Financial Officer
Slide 19: YTD 2023 Key Financial Highlights
YTD 2023 Key Financial Highlights1 Total revenues2 Profit before tax € 2.3 bn € 0.5 bn Diluted EPS Total cash plus security investments3 € 1.94 € 17.0 bn 1. Financial information is prepared and presented in Euros and numbers are rounded to millions and billions of Euros in accordance with standard
Slide 20: Q3 and YTD 2023 Financial Results: Profit or Loss
Q3 and YTD 2023 Financial Results: Profit or Loss (in millions €, except per share data)1 Three months ended September 30 Nine months ended September 30 2023 2022 2023 2022 Commercial revenues2 893.7 3,394.8 2,336.6 12,923.3 Research & development revenues 1.6 66.4 3.4 109.0 Total revenues 895.3 3,4
Slide 21: Implications of Inventory Write-Downs and Other Charges related to COMIRNATY
Implications of Inventory Write-Downs and Other Charges related to COMIRNATY Charges1 mainly reflect that market demand has shifted from pandemic to endemic, flu-like setting; Under the gross profit-sharing agreement charges are borne by both collaboration partners Actual YTD 2023 Initially announce
Slide 22: 2023 Financial Year Guidance Updated
2023 Financial Year Guidance Updated1 Delta Initial guidance Updated guidance midpoint Mar 2023 Nov 2023 illustration5 COVID-19 vaccine Estimated BioNTech COVID-19 vaccine revenues ~ €5 bn ~ €4 bn ~ €1 bn* revenues for FY 2023 * reflecting €0.6 bn6 Pfizer charges R&D expenses2 €2,400 – 2,600 m €1,80
Slide 23: Strategic Outlook
4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 24: Strategic Priorities and Outlook
Strategic Priorities and Outlook COVID-191 Immuno-oncology Infectious diseases Sustain market leadership in COVID-19 Advance oncology pipeline across Initiate and accelerate clinical programs vaccines multiple solid tumors for high medical need indications Advance next-gen vaccines Grow pipeline of
Slide 25: Rollout Of Our XBB.1.5 Variant Adapted Vaccine
Rollout Of Our XBB.1.5 Variant Adapted Vaccine1 Maintaining COVID-19 market leadership with variant- Potential for continued variant-adapted vaccine uptake2 adapted vaccine rollout ~30% of US population have received or plan to receive # of countries distributed to 40+ an XBB.1.5 variant-adapted vac
Slide 26: COVID-19 Vaccine Market Potential 2024 and 2025 Growth Drivers
COVID-19 Vaccine Market Potential 2024 and 2025 Growth Drivers 2024 2025 Variant adapted • Manufacturing base reset to serve endemic market vaccines Combination • Shift to commercialization model in some key markets vaccines • Expect continued shift to single dose vials and pre-filled syringes Next-
Slide 27: Strategic Outlook for Oncology
Strategic Outlook for Oncology Plans to start additional late-stage trials for select assets in Pipeline progress achieved in 2023 the next 18 months New oncology clinical trials started year-to-date1: BNT3162 anti-CTLA-4 Ab BNT3233 HER2 ADC BNT326/YL2024 HER3 ADC 5 Phase 1/2 4 Phase 2 PM80025 PD-L1
Slide 28: Innovation Series
Innovation Series Tomorrow, November 7, 2023 9:00 a.m. – 1:00 p.m. ET 3:00 p.m. – 7:00 p.m. CET Register to attend online using the QR code
Slide 29: Thank you
—_ Thank you BIONT=Cr