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 BioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer regarding a COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 in our continuing trials and/or in commercial use based on data observations to date, including real-world data gathered; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on trial data of BNT162b2 in our ongoing trials; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates and targets for 2021 and 2022;; BioNTech's target vaccine production for 2021; the planned next steps in BioNTech's pipeline programs and specifically including, but not limited to, statements regarding plans to initiate clinical trials of BioNTech's product candidates; BioNTech's plans for expansion in southeast Asia and China, including its planned regional headquarters and manufacturing facility in Singapore as well as the JV with Fosun Pharma; and expectations for data announcements with respect to BioNTech's clinical trials. 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 quarterly report 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. You should review the risks and uncertainties described under the heading "Risk Factors" in our quarterly report 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 quarterly report 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.
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AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION:
Do not administer Pfizer-BioNTechCOVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTechCOVID-19 Vaccine.
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer- BioNTech COVID-19 Vaccine.
Monitor Pfizer-BioNTechCOVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/).
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTechCOVID-19 Vaccine.
The Pfizer-BioNTechCOVID-19 Vaccine may not protect all vaccine recipients.
In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%).
Severe allergic reactions, including anaphylaxis, have been reported following the Pfizer-BioNTechCOVID-19 Vaccine during mass vaccination outside of clinical trials.
Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTechCOVID-19 Vaccine.
Available data on Pfizer-BioNTechCOVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
Data are not available to assess the effects of Pfizer-BioNTechCOVID-19 Vaccine on the breastfed infant or on milk production/excretion.
There are no data available on the interchangeability of the Pfizer-BioNTechCOVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTechCOVID-19 Vaccine should receive a second dose of Pfizer-BioNTechCOVID-19 Vaccine to complete the vaccination series.
Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS athttps://vaers.hhs.gov/reportevent.htmlor by calling 1-800-822-7967. The reports should include the words "Pfizer-BioNTechCOVID-19 Vaccine EUA" in the description section of the report.
Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTechCOVID-19 Vaccine Administration Under Emergency Use Authorization.
Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com.
Next generation Immunotherapy
Harnessing the full
potential of the immune system
Building a fully integrated biopharmaceutical company
Immunotherapies for cancer & infectious diseases and beyond
Broad suite of novel technologies
Industry-leading global collaborations
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Transformed into a fully integrated, global immunotherapy company
Fully Integrated Structure
Deep Immunology Expertise
Broad Suite of Novel Technologies
Global Team of 2,000+
A Robust Pipeline of 20+ Candidates
Immunotherapies & Vaccines
Oncology, Infectious Disease
Accelerated by Proven Execution and COVID-19 Vaccine Cash Flow
Next 5 Years
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