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 2 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 profi
Slide 3: Agenda
Financial Results Jens Holstein, Chief Financial Officer3 Strategic Outlook Ryan Richardson, Chief Strategy Officer4 Pipeline Update Özlem Türeci, Chief Medical Officer2 3rd Quarter 2023 Highlights Ugur Sahin, Chief Executive Officer1
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
Clinical data updates Strategic Priorities and Achievements in Q3 2023 and Post Period 5 1. Partnered with Pfizer; 2. Partnered with DualityBio; 3. Partnered with Genmab; 4. Partnered with OncoC4; 5. Partnered with Regeneron; 6. Partnered with CEPI. Initiated Trial COVID-19 franchise1 Infectious dis
Slide 6: Strong Global Distribution COMIRNATY Q3 Highlights
Strong Global Distribution COMIRNATY1 Q3 Highlights 1. Partnered with Pfizer. 2.COMIRNATY approved for prevention of COVID-19 as a single dose for individuals 5 years of age and older and as a 3-dose series in individuals 6 months through 4 years of age. 3. COMIRNATY may be administered as a booster
Slide 7: Hospitalizations Likely to Increase this Winter and Stay Within Last Year's Range
0 20k 40k 60k 80k 0 20k 40k 60k 80k 0 20k 40k 60k 80k Jan 2023 Apr 2023 Jul 2023 Oct 2023 Jan 2024 Apr 2024 Jul 2024 Oct 2024 Jan 2025 Apr 2025 Jan 2023 Apr 2023 Jul 2023 Oct 2023 Jan 2024 Apr 2024 Jul 2024 Oct 2024 Jan 2025 Apr 2025 Hospitalizations Likely to Increase this Winter and Stay Within La
Slide 8: Statistically Significant Reduction in Developing Long COVID after mRNA Vaccination
Probability of developing long COVID in vaccinated vs non-vaccinated individuals Statistically Significant Reduction in Developing Long COVID after mRNA Vaccination 8 Prevalence of ongoing symptoms lasting at least 3 months after COVID-19 infection by age, regardless of COVID status, U.S. 1 0.8 1.9
Slide 9: Long-Term Need for Annually Adapted Vaccines Anticipated
XBB.1.5-adapted vaccine Effective against multiple variants of concern5 Long-term health consequences Accumulating evidence demonstrates that COVID-19 vaccination may reduce long COVID conditions4 Continuous evolution Ongoing antigenic evolution of SARS-CoV-21,2 Risk remains high For severe COVID-19
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 11 1. Partnered with Pfizer; 2. Collaboration with University of Pennsylvania; 3. Collaboration with Bill & Melinda Gates Foundation; 4. Partnered with CEPI; HSV = herpes simplex virus; qFlu = quadrivalent influenza. Please find cu
Slide 12: XBB Sublineages Continue to Dominate the Epidemiologic Landscape
XBB Sublineages Continue to Dominate the Epidemiologic Landscape Despite the Emergence of New Lineages 12 Source: GISAID - gisaid.org, data accessed on September 08, 2023. Growing dominance of the XBB-descendent EG.5.1 In the US, EG.5 is one of the three most prevalent variants and is a descendent l
Slide 13: Monovalent XBB.1.5 Adapted Vaccine Elicits Higher nAbs Responses in Preclinical Models
Monovalent XBB.1.5 Adapted Vaccine Elicits Higher nAbs Responses against VoCs Compared to the Bivalent BA.4/5 Adapted Vaccine in Preclinical Models 13 Source: Data were generated by the same pseudovirus neutralization assay and from sera of same mouse study that generated data that were presented at
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 14 mRNA = messenger ribonucleic acid; IM = intramuscular. Sponsor: BioNTech Collaborator: Pfizer BNT162b2 (OmiXBB.1.5) (NCT05997290) Phase 2/3, open label, controlled safety and efficacy study Inclusion criteria Healthy particip
Slide 15: Clinical Study Demonstrated Monovalent XBB.1.5 BNT162b2 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 15 Source: Stankov M. V. et al., medRxiv preprint, October 5, 2023, doi: https://doi.org/10.1101/2023.10.04.23296545; NT50 = 50% neutralizing titer. N T5 0 [R ec ip r. di lu tio n fa
Slide 16: Oncology Pipeline: Achievements in Q3 2023 and Post Period Events
Oncology Pipeline: Achievements in Q3 2023 and Post Period Events 16 1. Partnered with Genentech, member of Roche Group; 2. Partnered with Regeneron; 3. Partnered with Genmab; 4. Partnered with OncoC4; 5. Partnered with DualityBio; 6. Partnered with MediLink Therapeutics. *Two phase 1/2 clinical tri
Slide 17: Multiple Clinical Data Readouts at Major Medical Conferences in 2H 2023
Multiple Clinical Data Readouts at Major Medical Conferences in 2H 2023 17 1. Partnered with DualityBio. ADC = antibody drug conjugate; HER2 = human epidermal growth factor 2; EC = endometrial cancer; TEAE = treatment emergent adverse event; ILD = interstitial lung disease; NSCLC = non-small cell lu
Slide 18: Financial Results
3 Financial Results Jens Holstein, Chief Financial Officer
Slide 19: YTD 2023 Key Financial Highlights
YTD 2023 Key Financial Highlights1 19 1. Financial information is prepared and presented in Euros and numbers are rounded to millions and billions of Euros in accordance with standard commercial practice. Inventory write-downs and other charges from Pfizer reduced BioNTech’s revenues by €615.4 milli
Slide 20: Q3 and YTD 2023 Financial Results: Profit or Loss
Q3 and YTD 2023 Financial Results: Profit or Loss 20 1. Numbers have been rounded; numbers presented may not add up precisely to the totals and may have been adjusted in the table context. Presentation of the unaudited interim consolidated statements of profit or loss has been condensed. 2. BioNTech
Slide 21: Implications of Inventory Write-Downs and Other Charges related to COMIRNATY
Implications of Inventory Write-Downs and Other Charges related to COMIRNATY 21 1. Inventory write-downs and other charges, jointly referred to as charges, were mainly triggered by market demand shifting from pandemic into endemic setting as well as the companies following the guidance from regulato
Slide 22: 2023 Financial Year Guidance Updated
2023 Financial Year Guidance Updated1 22 ~ €1 bn*~ €4 bn~ €5 bnEstimated BioNTech COVID-19 vaccine revenuesCOVID-19 vaccine revenues for FY 2023 ~ €600 m€1,800 – 2,000 m€2,400 – 2,600 mR&D expenses2 Planned FY 2023 expenses and capex ~ €75 m€600 – 650 m€650 – 750 mSG&A expenses ~ €300 m€200 – 300 m€
Slide 23: Strategic Outlook
4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
Slide 24: Strategic Priorities and Outlook
Strategic Priorities and Outlook 1. Partnered with Pfizer. COVID-191 Immuno-oncology Infectious diseases Sustain market leadership in COVID-19 vaccines Advance next-gen vaccines Advance oncology pipeline across multiple solid tumors Grow pipeline of trials with registrational potential Initiate and
Slide 25: Rollout Of Our XBB.1.5 Variant Adapted Vaccine
Rollout Of Our XBB.1.5 Variant Adapted Vaccine1 25 1. As of October 2, 2023. 2. Company assessment 3. CDC Survey published on October 28, 2023: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-10-25-26/02-COVID-Stokley-508.pdf. # of countries distributed to market share US/EU/JP (%)2
Slide 26: COVID-19 Vaccine Market Potential 2024 and 2025 Growth Drivers
COVID-19 Vaccine Market Potential 2024 and 2025 Growth Drivers 26 • Manufacturing base reset to serve endemic market • Shift to commercialization model in some key markets • Expect continued shift to single dose vials and pre-filled syringes • Potential for increased vaccine uptake from combination
Slide 27: Strategic Outlook for Oncology
Strategic Outlook for Oncology 27 1. New trial either through initiation or via in-licensing; 2. Partnered with OncoC4; 3. Partnered with DualityBio; 4. Partnered with Medilink Therapeutics; 5. Partnered with Biotheus; 6. Partnered with Regeneron; 7. Partnered with Genentech, member of Roche Group;
Slide 28: Innovation Series: Register to attend online
Register to attend online using the QR code Tomorrow, November 7, 2023 9:00 a.m. – 1:00 p.m. ET 3:00 p.m. – 7:00 p.m. CET Innovation Series
Slide 29: Thank you
Thank you BIONT=CrH