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BioNTech SE (BNTX)

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  • Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study
    GlobeNewswire

    Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study

    Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates BNT162b2 is highly effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to six months after the second doseVaccine was 100% effective in preventing severe disease as defined by the U.S. Centers for Disease Control and Prevention and 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration Vaccine was 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage is prevalentVaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second doseThe companies plan to share these results with worldwide regulatory agencies soon New York and Mainz, Germany, April 1, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced updated topline results from analysis of 927 confirmed symptomatic cases of COVID-19 observed in their pivotal Phase 3 study through March 13, 2021, showing that the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, was 91.3% effective against COVID-19, measured seven days through up to six months after the second dose. The vaccine was 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC), and 95.3% effective against severe COVID-19 as defined by the U.S. Food and Drug Administration (FDA). Safety data from the Phase 3 study has also been collected from more than 12,000 vaccinated participants who had a follow-up time of at least six months after the second dose, demonstrating a favorable safety and tolerability profile. “These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “The high vaccine efficacy observed through up to six months following a second dose and against the variant prevalent in South Africa provides further confidence in our vaccine’s overall effectiveness.” “It is an important step to further confirm the strong efficacy and good safety data we have seen so far, especially in a longer-term follow-up,” said Ugur Sahin, CEO and Co-founder of BioNTech. “These data also provide the first clinical results that a vaccine can effectively protect against currently circulating variants, a critical factor to reach herd immunity and end this pandemic for the global population.” About the Analysis The updated analysis of the Phase 3 clinical trial was conducted in accordance with guidance from the FDA for all companies investigating COVID-19 vaccines to review safety and efficacy at key milestones. Results from this analysis of 46,307 trial participants build upon and confirm previously released data and demonstrate strong protection against COVID-19 through six months post-second dose. From the 927 confirmed symptomatic cases of COVID-19 in the trial, 850 cases of COVID-19 were in the placebo group and 77 cases were in the BNT162b2 group, corresponding to vaccine efficacy of 91.3% (95% confidence interval [CI, 89.0, 93.2]). 32 cases of severe disease, as defined by the CDC, were observed in the placebo group versus none in the BNT162b2 vaccinated group, indicating that the vaccine was 100% efficacious in this analysis against severe disease by the CDC definition (95% CI, [88.0,100.0]). 21 severe cases, as defined by the FDA, were observed in the placebo group versus one case in the BNT162b2 vaccinated group, indicating 95.3% efficacy by the FDA definition (95% CI, [71.0, 99.9]). Efficacy was generally consistent across age, gender, race and ethnicity demographics, and across participants with a variety of underlying conditions. A total of 697 cases of COVID-19 were observed in the United States; 647 cases of COVID-19 were observed in the placebo group versus 50 in the vaccine group, indicating vaccine efficacy of 92.6% (95% CI, [90.1, 94.5]). In South Africa, where the B.1.351 lineage is prevalent and 800 participants were enrolled, nine cases of COVID-19 were observed, all in the placebo group, indicating vaccine efficacy of 100% (95% CI, [53.5, 100.0]). In an exploratory analysis, the nine strains were sequenced and six of the nine were confirmed to be of the B.1.351 lineage. These data support previous results from immunogenicity studies demonstrating that BNT162b2 induced a robust neutralizing antibody response to the B1.351 variant, and although lower than to the wild-type strain, it does not appear to affect the high observed efficacy against this variant.i No serious safety concerns were observed in trial participants up to six months after the second dose. Side effects were generally consistent with previously reported results. Vaccine safety has now been evaluated in more than 44,000 participants aged 16 years and older with more than 12,000 vaccinated participants having at least six months of follow-up after their second dose. Pfizer and BioNTech plan to submit detailed data for scientific peer review and potential publication in the near future. The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com. The vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorizations Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States, United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries. AUTHORIZED USE IN THE U.S.:The Pfizer-BioNTech COVID-19 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 16 years of age and older. IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 VaccineAppropriate 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 VaccineMonitor Pfizer-BioNTech COVID-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-BioNTech COVID-19 VaccineThe Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipientsIn 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-BioNTech COVID-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-BioNTech COVID-19 VaccineAvailable data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancyData are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretionThere are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination seriesVaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the reportVaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use AuthorizationPlease 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 About Pfizer: Breakthroughs That Change Patients’ LivesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Pfizer Disclosure NoticeThe information contained in this release is as of April 1, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (including qualitative assessments of available data, potential benefits, expectations for clinical trials, anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the topline data outlined in this release), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data (including the topline data outlined in this release); the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data (including the topline data outlined in this release) are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program (including the topline data outlined in this release) will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when a Biologics License Application for BNT162b2 may be filed in the U.S. and whether and when other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including a potential Biologics License Application in the U.S. or any requested amendments to the emergency use authorization) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine’s benefits outweigh its known risks and determination of the vaccine’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners or third-party suppliers; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine’s ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. About BioNTechBiopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de. BioNTech Forward-looking StatementsThis press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine (including a potential second booster dose of BNT162b2 and/or a potential booster dose of a variation of BNT162b2 having a modified mRNA sequence); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; 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; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report as Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law. Pfizer Contacts: Media RelationsJerica Pitts+1 (347) 224-9084Jerica.Pitts@pfizer.com Investor RelationsChuck Triano+1 (212) 733-3901Charles.E.Triano@Pfizer.com BioNTech Contacts: Media RelationsJasmina Alatovic+49 (0)6131 9084 1513Media@biontech.de Investor RelationsSylke Maas, Ph.D.+49 (0)6131 9084 1074Investors@biontech.de i New England Journal of Medicine. Neutralizing Activity of BNT162b2-Elicited Serum; March 8, 2021. Available at https://www.nejm.org/doi/full/10.1056/NEJMc2102017

  • Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents
    GlobeNewswire

    Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents

    In participants aged 12-15 years old, BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in trial of vaccinated 16-25 year old participants in an earlier analysis, and was well tolerated The companies plan to submit these data to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as soon as possible to request expansion of the Emergency Use Authorization (EUA) and EU Conditional Marketing Authorization for BNT162b2The companies also provided an update on the Phase 1/2/3 study of BNT162b2 in children aged 6 months to 11 years New York and Mainz, Germany, March 31, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated. These are topline results from a pivotal Phase 3 trial in 2,260 adolescents. “We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.” “Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant. It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones,” said Ugur Sahin, CEO and Co-founder of BioNTech. About the Phase 3 Data from Adolescents 12-15 Years of Age The trial enrolled 2,260 adolescents 12 to 15 years of age in the United States. In the trial, 18 cases of COVID-19 were observed in the placebo group (n=1,129) versus none in the vaccinated group (n=1,131). Vaccination with BNT162b2 elicited SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. This compares well (was non-inferior) to GMTs elicited by participants aged 16 to 25 years old (705.1 GMTs) in an earlier analysis. Further, BNT162b2 administration was well tolerated, with side effects generally consistent with those observed in participants 16 to 25 years of age. The companies plan to submit these data to the FDA and EMA for a requested amendment to the Emergency Use Authorization of BNT162b2 and the EU Conditional Marketing Authorization for COMIRNATY® to expand use in adolescents 12-15 years of age as quickly as possible. All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose. Pfizer and BioNTech plan to submit the data for scientific peer review for potential publication. Update on the Phase 1/2/3 Study in Children 6 months to 11 years old Last week, Pfizer and BioNTech dosed the first healthy children in a global Phase 1/2/3 seamless study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children 6 months to 11 years of age. The study is evaluating the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: children aged 5 to 11 years, 2 to 5 years, and 6 months to 2 years. The 5 to 11 year-old cohort started dosing last week and the companies plan to initiate the 2 to 5 year-old cohort next week. The Pfizer-BioNTech COVID-19 vaccine, BNT162b2, has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com. The vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorizations Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States, United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries. AUTHORIZED USE IN THE U.S.:The Pfizer-BioNTech COVID-19 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 16 years of age and older. IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: Do not administer Pfizer-BioNTech COVID-19 vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 vaccineAppropriate 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 vaccineMonitor Pfizer-BioNTech COVID-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-BioNTech COVID-19 vaccineThe Pfizer-BioNTech COVID-19 vaccine may not protect all vaccine recipientsIn 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-BioNTech COVID-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-BioNTech COVID-19 vaccineAvailable data on Pfizer-BioNTech COVID-19 vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancyData are not available to assess the effects of Pfizer-BioNTech COVID-19 vaccine on the breastfed infant or on milk production/excretionThere are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 vaccine should receive a second dose of Pfizer-BioNTech COVID-19 vaccine to complete the vaccination seriesVaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the reportVaccination providers should review the Fact Sheet for Information to Provide to vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 vaccine Administration Under Emergency Use AuthorizationPlease 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 About Pfizer: Breakthroughs That Change Patients’ LivesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Pfizer Disclosure NoticeThe information contained in this release is as of March 31, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program, the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), (including qualitative assessments of available data, potential benefits, expectations for clinical trials, the potential of BNT162b2 for adolescents 12 to 15 years of age, evaluation of BNT162b2 in children 6 months to 11 years old, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the data outlined in this release), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data (including the data outlined in this release) are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program (including the data outlined in this release) will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when a Biologics License Application for BNT162b2 may be filed in the U.S. and whether and when other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including a potential Biologics License Application in the U.S. or any requested amendments to the emergency use authorization) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine’s benefits outweigh its known risks and determination of the vaccine’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners or third-party suppliers; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine’s ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. About BioNTechBiopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de. BioNTech Forward-looking StatementsThis press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine (including a potential second booster dose of BNT162b2 and/or a potential booster dose of a variation of BNT162b2 having a modified mRNA sequence); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; 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; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law. Pfizer Contacts: Media RelationsJerica Pitts+1 (347) 224-9084Jerica.Pitts@pfizer.com Investor RelationsChuck Triano+1 (212) 733-3901Charles.E.Triano@Pfizer.com BioNTech Contacts: Media RelationsJasmina Alatovic+49 (0)6131 9084 1513Media@biontech.de Investor RelationsSylke Maas, Ph.D.+49 (0)6131 9084 1074Investors@biontech.de

  • BioNTech Announces Full Year 2020 Financial Results and Corporate Update
    GlobeNewswire

    BioNTech Announces Full Year 2020 Financial Results and Corporate Update

    BNT162b2 vaccine approved or authorized for emergency or temporary use in over 65 countries and regions after successful global Phase 3 trial demonstrated safety and efficacy in preventing COVID-19. More than 200 million doses of BNT162b2 supplied as of March 23, 2021, with signed orders for 1.4 billion doses to date for delivery in 2021. BioNTech and Pfizer expect to expand manufacturing capacity to up to 2.5 billion doses by end of 2021.Evaluation of safety and immunogenicity of a third BNT162b2 dose initiated to understand the effect of a booster to prolong immunity and protection against COVID-19 caused by the circulating and potential newly emerging SARS-CoV-2 variants, with additional studies planned. In oncology, first patient dosed in first-in-human trials for CARVac (BNT211) and RiboCytokines (BNT151). Development of oncology pipeline is accelerating with 13 product candidates in 14 ongoing trials; at least four data updates, up to three programs expected to move into randomized Phase 2 trials, and six preclinical programs moving into Phase 1 trials.Recognized first commercial COVID-19 vaccine revenues. Total COVID-19 vaccine revenues of €270.5 million1 for the Full Year 2020. Ended Full Year 2020 with strengthened financial position; cash and cash equivalents of €1.2 billion mainly as a result of financing transactions completed during the year. Conference call and webcast scheduled for March 30, 2021, at 08:00 a.m. ET (2:00 p.m. CET) MAINZ, Germany, March 30, 2021 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), a next generation immunotherapy company pioneering novel therapies for cancer and infectious diseases, today provided an update on its corporate progress and reported financial results for the quarter and full year ended December 31, 2020. “2020 was a transformational year for BioNTech with the development and approval of the first mRNA drug in history. As of March 2021, we had delivered more than 200 million doses of our vaccine to more than 65 countries and regions together with our partners, and we are already seeing the first signs of vaccine associated reduction of COVID-19 cases and mortality in multiple countries” said Ugur Sahin, Co-founder and CEO of BioNTech. “We will continue to focus on innovating in the COVID-19 field by advancing new formulations and addressing vaccine variants, as well as initiating new trials in additional sub-populations. At the same time, we are accelerating the development of our cancer immunotherapies. We see a tremendous opportunity to reinvest the proceeds from our COVID-19 vaccine into extending and accelerating the research and development of new vaccines and therapeutics to improve the health of people worldwide by harnessing the full potential of the immune system.” Fourth Quarter 2020 and Subsequent Updates Infectious disease COVID-19 vaccine program – BNT162b2 In December 2020, BNT162b2 became the first mRNA vaccine to be approved or authorized for emergency or conditional use. BNT162b2 now has authorization or approval for emergency use or temporary use in more than 65 countries worldwide, including the United States, United Kingdom and European Union. On November 18, 2020, BioNTech and Pfizer announced that BNT162b2 met the Phase 3 study’s primary efficacy endpoints in the final efficacy analysis. Analysis of the data indicated a vaccine efficacy rate of 95% for the prevention of a COVID-19 disease, measured seven days after the second dose. No serious safety concerns related to the vaccine were observed in the trial, with most solicited adverse events resolving shortly after vaccination. On December 10, 2020, results from the trial were published in the New England Journal of Medicine.On March 11, 2021, BioNTech and Pfizer announced additional real-world evidence data from the Israel Ministry of Health (MoH) that demonstrated dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with our COVID-19 vaccine. The latest data from the MoH show that two weeks after the second vaccine dose, protection is even stronger with a vaccine effectiveness of at about 97% in preventing symptomatic disease, severe/critical disease and death. The analysis also showed a vaccine effectiveness of 94% against asymptomatic SARS-CoV-2 infections. Since this observational analysis was conducted when the variant B.1.1.7 (UK variant) was the dominant strain in Israel, it also provides real-world evidence of the effectiveness of BNT162b2 for prevention of COVID-19 infections, hospitalizations and deaths due to variant B.1.1.7. The data from this observational analysis were published on March 24, 2021, on Lancet’s preprint server. Clinical development updates On October 21, 2020, BioNTech and Pfizer announced the start of a Phase 1/2 clinical trial in Japan to evaluate safety, tolerability and immunogenicity of BNT162b2 in healthy adults 20 to 85 years of age.On November 25, 2020, BioNTech and Fosun Pharma announced the start of a Phase 2 clinical trial of BNT162b2 in China to evaluate the safety and immunogenicity of BNT162b2 in healthy adults.On February 18, 2021, BioNTech and Pfizer announced that the first participants were dosed in a global Phase 2/3 trial to evaluate the safety, tolerability and immunogenicity of BNT162b2 in preventing COVID-19 in approximately 4,000 healthy pregnant women 18 years of age and older. The study will also assess safety in infants of vaccinated pregnant women and the transfer of potentially protective antibodies to their infants. On February 18, 2021, BioNTech and Pfizer announced that safety and efficacy data from the global Phase 3 study with subjects 12 to 15 years of age are expected to be submitted to the regulatory authorities in the second quarter of 2021.On February 25, 2021, BioNTech and Pfizer announced a trial to evaluate the safety and immunogenicity of a third dose of our COVID-19 vaccine on prolonging immunity against COVID-19 and to address potential newly emerging SARS-CoV-2 variants. In March, 2021, the U.S Food and Drug Administration (FDA) approved an additional amendment to the study protocol of the global Phase 1/2/3 trial for an additional dose of BNT162b2 or its modified version carrying the spike protein sequence of the South African variant (BNT162b2SA) in order to further describe duration of protection, and protection against the emerging variants of concern. An additional dose of either BNT162b2 or BNT162b2SA will be given to approximately 600 Phase 3 participants about five to seven months after their second dose of BNT162b2. A further dose of BNT162b2SA will be given to approximately 30 of those participants who receive BNT162b2SA. Approximately 300 BNT162b2-naïve participants will be enrolled and receive two doses of BNT162b2SA to describe protection against the emerging variants of concern and reference strains. The part of the trial with BNT162b2SA is expected to start in the second quarter of 2021.In March 2021, first participants were dosed in a Phase 1/2/3 study in healthy children 6 months to under 12 years of age. The Phase 1 dose-finding portion will evaluate the safety, tolerability and immunogenicity of two doses of BNT162b2 separated by 21 days in up to three age groups. Once the preferred dose level of BNT162b2 is identified for each age group, a Phase 2/3 trial to evaluate the safety, tolerability and immunogenicity in each age group will start. In addition, efficacy against confirmed COVID-19 and against asymptomatic infection will be assessed. Approximately 450 participants (300 in the BNT162b2 group and 150 in the placebo group) in each age group are expected to contribute to the immunobridging and persistence of immune response at 6 months after second dose analyses. Participants will be unblinded at the 6-month follow-up visit and participants that received placebo will be offered the opportunity to receive BNT162b2. All of the expected 4,500 participants will contribute to the vaccine effectiveness (VE) analysis for conditional VE and asymptomatic infection. BioNTech and Pfizer are also planning studies to further evaluate the vaccine in people with compromised immune systems.BioNTech and Pfizer will start a Phase 3 trial to evaluate the safety, tolerability and immunogenicity of lyophilized BNT162b2 presented in single-dose vials and of frozen liquid BNT162b2 in multidose vials. This trial will also assess the non-inferiority of the lyophilized formulation. The trial will be conducted in healthy adults 18 through 55 years of age and will start in the United States in April. We expect data from this trial in the third quarter of 2021. Data on SARS-CoV-2 variants On March 8, 2021, BioNTech and Pfizer published data in the New England Journal of Medicine from an in vitro study of the neutralizing activity of BNT162b2-elicited serum against the variants first detected in the United Kingdom (B.1.1.7 lineage), Brazil (P.1 lineage) and South Africa (B.1.351 lineage). The findings provide strong support that BNT162b2 will continue to protect against the B.1.1.7 lineage and the P.1 lineage. Sera neutralized all the viruses tested and showed no significant reduction in activity against both B.1.1.7-spike and P.1-spike viruses. While neutralization of the B.1.351-spike virus was lower, it was still robust. Regulatory updates On December 2, 2020, BioNTech and Pfizer announced that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom granted a temporary authorization for emergency use for BNT162b2 against COVID-19.On December 11, 2020, BioNTech and Pfizer announced that the U.S. FDA authorized the emergency use of BNT162b2 in individuals 16 years of age or older. BNT162b2 is authorized in the United States under an Emergency Use Authorization (EUA) while BioNTech and Pfizer gather additional data and prepare to file a planned Biologics License Application (BLA) with the U.S. FDA for full regulatory approval in 2021.On December 21, 2020, BioNTech and Pfizer announced the European Commission (EC) granted a conditional marketing authorization (CMA) for BNT162b2 in individuals 16 years of age and older. The CMA is valid in all 27 member states of the European Union.On February 14, 2021, Japan’s Health Ministry approved BNT162b under the exceptional approval scheme in Japan.On February 25, 2021, the U.S. FDA and on March 26, 2021, the EMA, approved that undiluted frozen vials of BNT162b2 may be transported and stored at conventional temperatures commonly found in pharmaceutical freezers (-25°C to -15°C or -13°F to 5°F) for a period of up to two weeks. Further formulation optimization activities are ongoing. Commercial UpdatesWe and our collaboration partners have supplied more than 200 million doses of our COVID-19 vaccine worldwide, as of March 23, 2021.BioNTech and Pfizer have signed orders of 1.4 billion doses for delivery in 2021. Discussions for additional dose commitments are ongoing. On February 12, 2021, BioNTech and Pfizer announced that the U.S. government exercised its option for an additional 100 million doses of our COVID-19 vaccine. This agreement brings the total number of doses to be delivered to the United States to 300 million. Consistent with the agreements for the prior 200 million doses, the U.S. government will pay $1.95 billion for the additional 100 million doses.On February 17, 2021, BioNTech and Pfizer announced an agreement with the EC to supply an additional 200 million doses of our COVID-19 vaccine. The EC has an option for an additional 100 million doses. The total number of doses to be delivered to the European Union by the end of 2021 is now 500 million, with an option for an additional 100 million doses. ManufacturingBioNTech and Pfizer expect to increase BNT162b2 manufacturing capacity to up to 2.5 billion doses by the end of 2021. The increase is driven by the optimization of production processes, the recent initiation of production at BioNTech’s Marburg, Germany facility, regulatory approval for six dose vials, and the expansion of our manufacturing and supplier network. Additional measures and discussions with potential partners to further expand the manufacturing capacity and network are ongoing. In October 2020, BioNTech acquired a GMP manufacturing facility in Marburg, Germany, to accelerate BNT162b2 manufacturing scale-up for commercial supply in 2021. On March 26, 2021, BioNTech announced that the European Medicines Agency (EMA) approved the manufacturing of our COVID-19 vaccine drug product at the facility in Marburg. The approvals make BioNTech’s Marburg manufacturing site one of the largest mRNA vaccine manufacturing sites worldwide with an annual production capacity of up to one billion doses of our COVID-19 vaccine, once fully operational. Due to optimized operational efficiencies which were initiated last year, BioNTech was able to increase the expected annual manufacturing capacity by 250 million doses. The first batches of vaccines manufactured at the Marburg site are expected to be delivered in the second half of April. BioNTech plans to produce up to 250 million doses of BNT162b2 in the first half of 2021. Oncology BioNTech is accelerating the development of its broad oncology pipeline with 13 product candidates in 14 ongoing trials. In 2021, we expect at least four data updates from our oncology pipeline with up to three programs expected to move into randomized Phase 2 trials and six preclinical programs moving into Phase 1 trials. This includes the first-in-human trials started for the lead candidates for both the CARVac (BNT211) and RiboCytokines (BNT151) product candidates. mRNA programsFixVac BNT111 – We expect to start a randomized Phase 2 trial for the treatment of patients with advanced melanoma progressing during or after prior therapy with a PD-1 inhibitor, utilizing a combination of BNT111 and Regeneron and Sanofi’s Libtayo® (Cemiplimab) in the first half of 2021 in the United States and the European Union. Our IND for this trial in the United States is active as is a CTA approval in the European Union.BNT113 – We expect to start a Phase 2 trial evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment in patients with unresectable recurrent or metastatic HPV16+ head and neck squamous cell carcinoma (HNSCC) expressing PD-L1 in the first half of 2021 in the United States and the European Union. BNT113 has not been combined with anti-PD1 before and the Phase 2 trial will start with a run in portion designed to demonstrate the safety of the combination of BNT113 and pembrolizumab. These data are required to address the partial clinical hold on the subsequent randomized part of the Phase 2 trial. Individualized neoantigen specific immunotherapy (iNeST) Our iNeST product candidate BNT122 is partnered with Genentech. BNT122 has been given the international non-proprietary name (INN) “autogene cevumeran”. An open-label Phase 1a/1b trial evaluating the safety, tolerability, immune response and pharmacokinetics of autogene cevumeran as a single agent and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors (basket trial) is ongoing.A Phase 2 open-label trial evaluating the efficacy and safety of autogene cevumeran in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated advanced melanoma is ongoing.Given challenging accrual timelines in the context of the SARS-CoV-2 pandemic and the evolving landscape of treatment options in non-small cell lung cancer (NSCLC), BioNTech and Genentech decided to discontinue the previously planned Phase 2 trial in patients with high-risk resected early stage NSCLC. Genentech and BioNTech are evaluating further options for treating early disease cancer patients with autogene cevumeran. One of these early disease development options is adjuvant treatment of colorectal cancer. First patient dosing in a randomized Phase 2 trial in circulating tumor DNA positive, surgically resected Stage 2 (high risk)/Stage 3 colorectal cancer is expected in the first half of 2021. RiboCytokines BNT151 is a nucleoside-modified mRNA encoding for an IL-2 variant, a key cytokine in T cell immunity supporting the differentiation, proliferation, survival and effector functions of T cells. BNT151 is designed to stimulate anti-tumoral T cells without extensively triggering immunosuppressive regulatory T cells. In February 2021, the first patient was dosed in a first-in-human, open-label, multicenter Phase 1/2a trial. The trial evaluates dose escalation, safety, pharmacokinetics and pharmacodynamics of BNT151 with expansion cohorts in multiple solid tumor indications, including HNSCC, hepatocellular carcinoma (HCC), renal cell cancer (RCC), NSCLC, and triple-negative breast cancer (TNBC). The monotherapy dose escalation will enroll patients with tumors that are metastatic or unresectable with no available standard therapy likely to confer clinical benefit. In the combined treatment dose escalation, patients with different solid tumors will be enrolled and treated with BNT151 and the respective standard of care. BNT152+153 – In February, the U.S. FDA approved the IND for a Phase 1 trial for BNT152+153. We plan to start a Phase 1 trial for BNT152 (encoding IL-7) plus BNT153 (encoding IL-2) in multiple solid tumors in the first half of 2021. RiboMabs BNT141 – In February, the U.S. FDA approved the IND for a Phase 1 first-in-human clinical trial for BNT141. We expect to start the trial in the second half of 2021. BNT142 – We expect to start a Phase 1 clinical trial for BNT142 in the second half of 2021. AntibodiesNext-generation checkpoint immunomodulators BNT311 and BNT312 are partnered with Genmab. BNT311/GEN1046 – Data from a first-in-human Phase 1/2a trial of BNT311 (PD-L1x4-1BB) in 61 heavily pretreated patients with advanced solid tumors was presented at the SITC conference in November 2020. We expect a data update from this trial in the second half of 2021. BNT312/GEN1042 – We expect first data disclosure from the Phase 1/2a trial of BNT312 in solid tumors in the second half of 2021. Cell therapiesCAR-T cell immunotherapy BNT211, BioNTech’s most advanced CAR-T product candidate, targets the tumor-specific antigen CLDN6 and was developed in combination with a CAR-T cell Amplifying RNA Vaccine (CARVac) that encodes the CAR target for in vivo expansion upon CAR-T administration. CARVac is based on RNA-LPX technology known from FixVac and selectively delivers the RNA-encoded CAR target to antigen presenting cells, leading to CAR target expression on the cell surface. BNT211 – In February 2021, the first patient was dosed in a first-in-human Phase 1/2a open-label, multi-center dose escalation and dose expansion basket trial of BNT211 with or without a CLDN6 CARVac in patients with CLDN6-positive relapsed or refractory advanced solid tumors including but not limited to ovarian and testicular cancers. The combination with CLDN6 CARVac is expected to improve expansion and persistence of CLDN6 CAR-T. The primary outcome measure of the trial will be safety, with secondary efficacy outcome measures to include objective response rate, disease control rate and duration of response. We expect a data update for this trial in the second half of 2021. Neoantigen-targeting T cell therapy BNT221 (NEO-PTC-01) – Dosing of the first patient in a Phase 1 dose escalation trial for the treatment of metastatic melanoma in patients who are refractory or unresponsive to checkpoint inhibitors is expected in the first half of 2021. The primary objectives of the trial will be to evaluate the safety and feasibility of administering BNT221, in addition to an evaluation of immunogenicity and clinical efficacy. Small molecule immunomodulatorsToll-like receptor binding agonist BNT411 – A Phase 1/2a dose-escalation trial of BNT411 as a monotherapy in patients with solid tumors, and in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC) remains ongoing. We expect a data update from this trial in the second half of 2021. Full Year 2020 Financial ResultsRevenues: Total revenues were estimated to be €345.4 million for the three months ended December 31, 2020, compared to €28.0 million for the three months ended December 31, 2019. For the year ended December 31, 2020, total revenues were estimated to be €482.3 million, compared to €108.6 million for the comparative prior year period. Total revenues increased due to recognizing revenues for the first time under our two new collaboration agreements to develop a COVID-19 vaccine and ultimately led to the recognition of COVID-19 vaccine commercial revenues. Under the Pfizer collaboration, territories have been allocated to BioNTech and Pfizer based on marketing and distribution rights. Our commercial revenues comprise an estimated amount of €188.5 million1 share of gross profit from COVID-19 vaccine sales in the collaboration partner’s territory, which represents a net figure. In addition, €61.4 million sales to our collaboration partner of products manufactured by us and €20.6 million direct COVID-19 vaccine sales to customers in our territory Germany have been recognized. Cost of Sales: Cost of sales were estimated to be €41.0 million for the three months ended December 31, 2020, compared to €4.4 million for the three months ended December 31, 2019. For the year ended December 31, 2020, cost of sales were estimated to be €59.3 million, compared to €17.4 million for the comparative prior year period. €35.6 million estimated cost of sales were recognized for the first time with respect to our COVID-19 vaccine sales and include Pfizer’s share of gross profits earned by BioNTech. Cost of sales do not include costs relating to production of pre-launch products since those are expensed as research and development expenses in the period incurred. Research and Development Expenses: Research and development expenses were €257.0 million for the three months ended December 31, 2020, compared to €65.4 million for the three months ended December 31, 2019. For the year ended December 31, 2020, research and development expenses were €645.0 million, compared to €226.5 million for the comparative prior year period. The increase was mainly due to an increase in research and development expenses for our BNT162 program. Research and development expenses include our share of expenses under the terms of the Pfizer collaboration agreement. Development costs are shared equally between Pfizer and us. The increase was further driven by an increase in expenses for purchased laboratory supplies as well as an increase in headcount leading to higher wages, benefits and social security expenses. In addition, from May 6, 2020, the date of acquisition of our new U.S.-based subsidiary, BioNTech US Inc., contributed to our research and development expenses. General and Administrative Expenses: General and administrative expenses were €36.1 million for the three months ended December 31, 2020, compared to €11.1 million for the three months ended December 31, 2019. For the year ended December 31, 2020, general and administrative expenses were €94.0 million, compared to €45.5 million for the comparative prior year period. The increase was mainly due to higher expenses for professional services, an increase in headcount leading to higher wages, benefits and social security expenses and higher insurance premiums. In addition, from May 6, 2020, the date of acquisition of our new U.S.-based subsidiary, BioNTech US Inc., contributed to our general and administrative expenses. Income Taxes: Following the authorization and approval of our COVID-19 vaccine for emergency or temporary use or having been granted conditional marketing authorization, the recognition of deferred tax assets was reevaluated. As of December 31, 2020, net deferred tax assets with respect to the accumulated tax losses and temporary differences of the German tax group were recognized with €161.0 million income tax effect. Net Profit / Loss: Net profit was €366.9 million for the three months ended December 31, 2020, compared to €58.2 million net loss for the three months ended December 31, 2019. For the year ended December 31, 2020, net profit was €15.2 million, compared to €179.2 million net loss for the comparative prior year period.Cash Position: Cash and cash equivalents as of December 31, 2020 were €1.2 billion. Shares Outstanding: Shares outstanding as of December 31, 2020 were 241,521,065. COVID-19 vaccine order book update: Estimated COVID-19 vaccine revenues to BioNTech upon delivery of currently signed supply contracts (~1.4 billion doses): ~€9.8 billion. Estimate reflects: Expected revenues from direct COVID-19 vaccine sales to customers in our territoriesExpected revenues from sales to our collaboration partnersExpected sales milestone payments from our collaboration partnersExpected revenues related to our share of gross profit from COVID-19 vaccine sales in the collaboration partners’ territories Additional revenues related to further supply contracts for deliveries in 2021 expected. Full year 2021 manufacturing capacity target raised from 2.0 to 2.5 billion doses to be able to address increased demand. 2021 financial outlook: BioNTech is providing the following outlook for the full year 2021 of selected financial metrics based on the current base case projections: Planned Full Year 2021 Expenses and Capex2 R&D expenses €750 million – €850 million Ramp-up of R&D investment in 2H 2021 and beyond planned to broaden and accelerate pipeline development. SG&A expenses Up to €200 million Capital expenditures €175 million – €225 million Estimated Full Year 2021 Tax Assumptions German tax group corporate tax rate ~31% German tax group accumulated tax loss carryforwards as of December 31, 2020 ~€450million3 Full financial statements can be found in the 20F filing as published on the SEC website under https://www.sec.gov/. 1 Estimated figures based on preliminary data shared between Pfizer and BioNTech as fully described in our Annual Report on Form 20-F. Changes in our share of the collaboration partner’s gross profit will be recognized prospectively. 2 Ranges reflect current base case projections. 3 €457.9 million corporate income tax losses and €450.9 million trade tax losses related to the German tax group. About BioNTechBiopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer. For more information, please visit www.BioNTech.de Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including BioNTech’s expected revenues and net profit related to sales of BioNTech and Pfizer’s COVID-19 vaccine, referred to as COMIRNATY® in the European Union as authorized for use under conditional marketing approval, in territories controlled by BioNTech’s collaboration partners, particularly those such figures that are derived from preliminary estimates provided by BioNTech’s partners; the extent to which a COVID-19 vaccine continues to be necessary in the future; 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 pricing and reimbursement of BioNTech and Pfizer’s COVID-19 vaccine and BioNTech’s investigational medicines, if approved; the rate and degree of market acceptance of BioNTech and Pfizer’s COVID-19 vaccine and BioNTech’s investigational medicines, if approved; the initiation, timing, progress, results, and cost of BioNTech’s research and development programs 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, the period during which the results of the trials will become available and BioNTech’s research and development programs; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for BioNTech’s product candidates; 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 personal injury or death arising from the use of BioNTech and Pfizer’s COVID-19 vaccine, and other products and product candidates developed or manufactured by BioNTech; BioNTech’s estimates of its expenses, ongoing losses, future revenue and capital requirements and BioNTech’s needs for or ability to obtain additional financing; the development of and projections relating to BioNTech’s competitors or its industry; BioNTech’s ability to effectively scale its production capabilities and manufacture its products, including BioNTech and Pfizer’s COVID-19 vaccine, and BioNTech’s product candidates; BioNTech’s projected net sales for the COVID-19 vaccine in 2021; BioNTech’s projected gross margins, expenses and expenditures and tax rate for 2021; BioNTech’s target vaccine production for 2021; and BioNTech’s COVID-19 vaccine revenues and net sales, which are subject to numerous estimates as more fully described in our Annual Report on Form 20-F. 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 press release 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 BioNTech’s Annual Report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on March 31, 2020 and in subsequent filings made by BioNTech with the SEC, including the third quarter report, which are available on the SEC’s website at 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 press release 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. Investor RelationsSylke Maas, Ph.D. VP Investor Relations & Strategy Tel: +49 (0)6131 9084 1074 E-mail: Investors@biontech.de Media RelationsJasmina AlatovicDirector Global External Communications Tel: +49 (0)6131 9084 1513 or +49 (0)151 1978 1385 E-mail: Media@biontech.de Consolidated Statements of Financial Position December 31, December 31, (in thousands)20202019Assets Non-current assets Intangible assets € 163,490€ 89,434Property, plant and equipment 226,96893,044Right-of-use assets98,98855,018Other assets1,045- Deferred tax assets 161,233- Total non-current assets € 651,724€ 237,496Current assets Inventories 64,12011,722Trade receivables 165,46811,913Other financial assets 137,2341,680Other assets60,9669,069Income tax assets 898756Deferred expenses28,0015,862Cash and cash equivalents1,210,209519,149Total current assets € 1,666,896€ 560,151Total assets€ 2,318,620€ 797,647 Equity and liabilities Equity Share capital246,310232,304Capital reserve1,514,451686,714Treasury shares(4,789)(5,525)Accumulated losses(409,629)(424,827)Other reserves 25,5034,826Total equity € 1,371,846€ 493,492Non-current liabilities Interest-bearing loans and borrowings231,04768,904Other financial liabilities 31,476- Provisions5,498- Contract liabilities71,89297,109Other liabilities 566- Deferred tax liabilities281- Total non-current liabilities € 340,760€ 166,013Current liabilities Interest-bearing loans and borrowings9,1425,307Trade payables102,28820,498Other financial liabilities 74,07510,352Government grants91,951- Tax provisions11150Other provisions903762Contract liabilities299,58393,583Other liabilities28,0617,490Total current liabilities€ 606,014€ 138,142Total liabilities € 946,774€ 304,155Total equity and liabilities € 2,318,620€ 797,647 Consolidated Statements of Operations Years ended December 31, 2020 2019 2018 (in thousands, except per share data) Revenues Research & development revenues € 178,849 € 84,428 € 101,837 Commercial revenues 303,476 24,161 25,738 Total revenues 482,325 108,589 127,575 Cost of sales (59,333) (17,361) (13,690) Research and development expenses (645,029) (226,466) (143,040) Sales and marketing expenses (14,512) (2,718) (3,041) General and administrative expenses (94,049) (45,547) (26,334) Other operating expenses (2,358) (739) (720) Other operating income 250,539 2,724 5,396 Operating loss € (82,417) € (181,518) € (53,854) Finance income* 1,564 4,122 8,046 Finance expenses* (62,946) (326) (48) Interest expenses related to lease liabilities (2,003) (1,718) (1,721) Share of loss of equity method investees - - (84) Loss before tax € (145,802) € (179,440) € (47,662) Income taxes 161,000 268 (600) Profit / (Loss) for the period € 15,198 € (179,172) € (48,262) Attributable to: Equity holders of the parent 15,198 (179,056) (48,019) Non-controlling interests - (116) (243) Profit / (Loss) for the period € 15,198 € (179,172) € (48,262) Earnings per share Basic and diluted, profit / (loss) for the period attributable to ordinary equity holders of the parent** € 0.06 € (0.85) € (0.25) * Foreign exchange differences on a cumulative basis are either shown as finance income or expenses and might switch between those two positions during the year-to-date reporting periods. ** Numbers of shares for calculating the earnings per share for the years ended December 31, 2019 and December 31, 2018 have been adjusted to reflect capital increase due to 1:18 share split which occurred on September 18, 2019. Consolidated Statements of Cash Flows Years ended December 31, 2020 2019 2018 (in thousands) Operating activities Profit / (Loss) for the period € 15,198 € (179,172) € (48,262) Income taxes (161,000) (268) 600 Loss before tax € (145,802) € (179,440) € (47,662) Adjustments to reconcile loss before tax to net cash flows: Depreciation and amortization of property, plant, equipment and intangible assets 38,744 33,896 21,984 Share-based payment expense 32,142 30,236 7,641 Net foreign exchange differences 41,275 70 459 (Gain) / Loss on disposal of property, plant and equipment 595 542 (14) Finance income (1,564) (1,782) (1,996) Interest on lease liability 2,003 1,717 1,721 Finance expense 20,336 326 48 Movements in government grants 91,951 - - Share of loss of an associate and a joint venture - - 84 Other non-cash income 1,749 - - Working capital adjustments: Decrease / (Increase) in trade receivable and contract assets (247,886) 2,939 (18,732) Decrease / (Increase) in inventories (49,794) (5,798) (1,253) (Decrease) / Increase in trade payables, other liabilities, contract liabilities and provisions 204,583 (80,577) (21,080) Interest received 1,444 1,256 1,996 Interest paid (3,628) (2,044) (1,769) Income tax received (paid), net 378 122 (304) Net cash flows used in operating activities € (13,474) € (198,537) € (58,877) Investing activities Purchase of property, plant and equipment (66,033) (38,592) (29,901) Proceeds from sale of property, plant and equipment 1,241 21 705 Purchase of intangibles assets and right of use assets (19,413) (32,488) (37,256) Acquisition of subsidiaries and businesses, net of cash acquired (60,643) (6,056) - Net cash flows used in investing activities € (144,848) € (77,115) € (66,452) Financing activities Proceeds from issuance of share capital, net of costs 753,007 375,351 361,725 Proceeds from loans and borrowings 156,027 11,000 5,600 Repayment of loans and borrowings (1,566) - - Payments related to lease liabilities (12,743) (3,061) (2,148) Net cash flows from financing activities € 894,725 € 383,290 € 365,177 Net increase in cash and cash equivalents 736,403 107,638 239,848 Change in cash and cash equivalents resulting from exchange rate differences (45,343) 16 (459) Cash and cash equivalents at January 1 519,149 411,495 172,106 Cash and cash equivalents at December 31 € 1,210,209 € 519,149 € 411,495