3rd Quarter 2023
Financial Results & Corporate Update
November 6, 2023
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 related to sales of BioNTech's COVID-19 vaccine, referred to as COMIRNATY® where approved for use under full or conditional marketing authorization, in territories controlled by BioNTech's collaboration partners, particularly for those figures that are derived from preliminary estimates provided by BioNTech's partners; the rate and degree of market acceptance of BioNTech's COVID-19 vaccine and, if approved, BioNTech's investigational medicines; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment, seasonality and expected regulatory recommendations to adapt vaccines to address new variants or sublineages; the initiation, timing, progress, results, and cost of BioNTech's research and development programs, including those relating to additional formulations of BioNTech's COVID-19 vaccine, and BioNTech's current and future preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work and the availability of results; our expectations with respect to our intellectual property; the impact of the Company's collaboration and licensing agreements; the development of sustainable vaccine production and supply solutions and the nature and feasibility of these solutions; and BioNTech's estimates of commercial and other revenues, cost of sales, research and development expenses, sales and marketing expenses, general and administrative expenses, capital expenditures, income taxes, net profit, cash, cash equivalents and security investments, shares outstanding and cash outflows and share consideration. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this presentation are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech's control, and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: BioNTech's pricing and coverage negotiations with governmental authorities, private health insurers and other third-party payors after BioNTech's initial sales to national governments; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; competition from other COVID-19 vaccines or related to BioNTech's other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the timing of and BioNTech's ability to obtain and maintain regulatory approval for BioNTech's product candidates; the ability of BioNTech's COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech's and its counterparties' ability to manage and source necessary energy resources; BioNTech's ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech's third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; the impact of the COVID-19 pandemic on BioNTech's development programs, supply chain, collaborators and financial performance; unforeseen safety issues and claims for potential personal injury or death arising from the use of BioNTech's COVID-19 vaccine and other products and product candidates developed or manufactured by BioNTech; BioNTech's and its collaborators' ability to commercialize and market BioNTech's COVID-19 vaccine and, if approved, its product candidates; BioNTech's ability to manage its development and expansion; regulatory developments in the United States and other countries; BioNTech's ability to effectively scale BioNTech's production capabilities and manufacture BioNTech's products, including BioNTech's target COVID-19 vaccine production levels, and BioNTech's product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading "Risk Factors" in BioNTech's Report on Form 6-K for the period ended September 30, 2023 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC's website at https://www.sec.gov/. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this presentation in the event of new information, future developments or otherwise. These forward-looking statements are based on BioNTech's current expectations and speak only as of the date hereof.
2
1
2
3
4
3rd Quarter 2023 Highlights
Ugur Sahin, Chief Executive Officer
Pipeline Update
Özlem Türeci, Chief Medical Officer
Financial Results
Jens Holstein, Chief Financial Officer
Strategic Outlook
Ryan Richardson, Chief Strategy Officer
1 3rd Quarter 2023 Highlights
Ugur Sahin, Chief Executive Officer
Strategic Priorities and Achievements in Q3 2023 and Post Period
COVID-19 franchise1
2023 Strategic Priorities
Sustain leadership in COVID-19 vaccines Advance next-gen vaccines
Q3 Achievements
Successful launch of XBB.1.5-adapted monovalent COVID-19 vaccine for 2023/2024 season
Clinical data updates
COVID-19-Influenza combo
Peer reviewed papers
Murdoch et al, Infect Dis Ther 2023 Muik et al, Cell Rep 2023
Arieta et al, Cell 2023
Beguir et al, Comput Biol Med 2023
Immuno-oncology
Advance oncology pipeline across multiple solid tumors Initiate multiple trials with registrational potential
Clinical data updates | |
ESMO | SITC |
BNT325/DB-13052 | BNT316/ONC-3924 (gotistobart) |
BNT314/GEN10593 | BNT221 |
BNT211 | BNT116 |
BNT221 | ESGO |
BNT323/DB-13032 | |
Initiated trials | Partnerships |
BNT323/DB-13032: Ph3 | DualityBio |
BNT324/DB-13112: Ph1/2 | MediLink |
BNT311/GEN10463: Ph2 | Biotheus |
BNT314//GEN10593: First-in-human
BNT1165: Ph2
Peer reviewed papers
Mackensen et al, Nature Med 2023
Bähr-Mahmud et al, Oncoimmunol 2023
Simon et al, J. Transl Med 2023
Infectious diseases
Initiate and accelerate clinical programs for diseases of unmet medical need
Initiated Trial
BNT1666 (Mpox): First-in-human
Partnership
Coalition for Epidemic Preparedness Innovations
1. Partnered with Pfizer; 2. Partnered with DualityBio; 3. Partnered with Genmab; 4. Partnered with OncoC4; 5. Partnered with Regeneron; 6. Partnered with CEPI.
5
COMIRNATY1 Q3 Highlights
Strong Global
Distribution
First-to-market Omicron XBB.1.5-adapted monovalent vaccine
Distributed to over 40 countries and regions worldwide
Rapid Regulatory
Advancement
EU: EMA Full Marketing Authorization for ages 6 months and older2
US: FDA sBLA for individuals 12+ years and EUA for ages 6 months to 11 years old3
Other select regions with approval: UK, Japan, Canada, Australia, Singapore and South Korea
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 in people aged 12 years and older who have received at least a primary vaccination course against COVID-19. EMA = European Medicines Agency; FDA = Food and Drug Administration;
sBLA = supplemental Biologics License Application; EUA = Emergency Use Authorization.
6
Hospitalizations Likely to Increase this Winter and Stay Within Last Year's Range1
65+ booster No booster
All booster
Incident Hospitalization
80k
60k | High threshold2 | |||||||||||||||||||
40k | Medium threshold3 | |||||||||||||||||||
20k | ||||||||||||||||||||
0 | ||||||||||||||||||||
80k | ||||||||||||||||||||
60k | High threshold2 | |||||||||||||||||||
40k | ||||||||||||||||||||
20k | Medium threshold3 | |||||||||||||||||||
0 | ||||||||||||||||||||
80k | ||||||||||||||||||||
60k | High threshold2 | |||||||||||||||||||
40k | ||||||||||||||||||||
20k | Medium threshold3 | |||||||||||||||||||
0 | ||||||||||||||||||||
Jan | Apr | Jul | Oct | Jan | Apr | Jul | Oct | Jan | Apr | Jan | Apr | Jul | Oct | Jan | Apr | Jul | Oct | Jan | Apr | |
2023 | 2023 | 2023 | 2023 | 2024 | 2024 | 2024 | 2024 | 2025 | 2025 | 2023 | 2023 | 2023 | 2023 | 2024 | 2024 | 2024 | 2024 | 2025 | 2025 | |
Low immune escape | High immune escape |
- ACIP Meeting September 12, 2023: Evidence to Recommendations Framework: 2023 - 2024 (Monovalent, XBB Containing) COVID-19 Vaccine; Modeling by Covid19 Scenario Modeling Hub.
- High threshold assumption defined as approximately 65746 hospitalizations; 3. Medium threshold assumption defined as approximately 32872 hospitalizations.
7
Statistically Significant Reduction in Developing Long COVID after mRNA Vaccination
Prevalence of ongoing symptoms lasting at least 3 months after COVID-19 infection
by age, regardless of COVID status, U.S.
Probability of developing long COVID in vaccinated vs non-vaccinated individuals
Inverse probability of treatment weighting adjusted Kaplan-Meier Curves
10 | 9 | 7.4 | |||||||||||
(%) | 8 | 6.8 | |||||||||||
Prevalence | 6 | 4.7 | 4.2 | ||||||||||
3.8 | |||||||||||||
4 | |||||||||||||
2.7 | 2.3 | ||||||||||||
1.9 | |||||||||||||
2 | 1 | ||||||||||||
0.8 | 0.3 | 0.8 | |||||||||||
0.2 | |||||||||||||
0 | |||||||||||||
0 - 5 | 6 - 11 | 12 - 17 | 18 - 34 | 35 - 49 | 50 - 64 | ≥ 65 | |||||||
years | years | years | years | years | years | years | |||||||
Ever | Current | ||||||||||||
of LC Diagnosis | 1.00 | |||||
0.99 | ||||||
0.98 | ||||||
1 - Probability | ||||||
0.97 | ||||||
0.96 | ||||||
45 | 100 | 150 | 200 | 250 | 300 |
Time from COVID index, day
Non-vaccinated
Vaccinated
CDC ACIP September 12, 2023
Brannock et al, Nature Comm. 2023
10-20% of SARS-CoV-2 infected | Long COVID also affects | Post COVID-19 conditions are | COVID-19 vaccination reduces | |||||
people may develop long COVID1,2 | children and may lead to long | associated with increased | post COVID-19 conditions | |||||
term effects on development3 | healthcare utilization4 | among children and adults5,6 |
1. Davis, H.E., et al. Nat Rev Microbiol 2023; 2. Editorial, The Lancet Vol 401 2023; 3. Villapol, S. et al Sci Rep Nat Res 2022; 4. Katz GM et al. JAMA Health Forum 2023; 5. Saydah, Centers for Disease Control Advisory Committee on Immunization Practices, September 12, 2023; 6. Brannock et al, Nature Comm. 2023. LC: Long Covid.
8
Long-Term Need for Annually Adapted Vaccines Anticipated
Continuous evolution
Ongoing antigenic evolution of SARS-CoV-21,2
Long-term health consequences
Accumulating evidence demonstrates that COVID-19 vaccination may reduce long COVID conditions4
Risk remains high | ||||||
For severe COVID-19 in | ||||||
Annual and/or | vulnerable populations3 | |||||
SEASONAL | ||||||
VACCINATION | ||||||
with variant-adapted | XBB.1.5-adapted vaccine | |||||
vaccines expected for the | ||||||
foreseeable future | ||||||
Effective against multiple variants of | ||||||
concern5 |
1. World Health Organization tracking SARS-CoV-2 variant www.who.int/en/activities/tracking-SARS-CoV-2-variantsaccessed October 30, 2023; 2. GISAID https://gisaid.org/accessed October 30, 2023; 3. FDA Briefing Document Vaccines and Related Biological Products Advisory Committee Meeting June 15, 2023; 4 Brannock et al, Nature Comm. 2023; 5. Stankov M. V. et al., medRxiv pre-print, accessed October 5, 2023.
9
Pipeline Update
Özlem Türeci, Chief Medical Officer
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
BioNTech SE published this content on 06 November 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 06 November 2023 13:19:55 UTC.