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    BNTX   US09075V1026

BIONTECH SE

(BNTX)
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Press Release: Pfizer and BioNTech Initiate -2-

05/07/2021 | 06:45am EDT
https://www.globenewswire.com/Tracker?data=WJ1gsG8RgN48zYloX6sIs5ipPqL8cNbDEtLiVm7MC80YWAsi6KRgRaIivVVmWruzZNATMqTrM1WKEXOpFyO1dw== 
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@Pfizer and 
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@Pfizer News, 
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Facebook.com/Pfizer. 
 
   Pfizer Disclosure Notice 
 
   The information contained in this release is as of May 7, 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, a rolling submission of a Biologics License Application 
(BLA) with the FDA for BNT162b2, 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 Phase 3 data), 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 upon 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 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 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 the submission of the BLA for 
BNT162b2 in the U.S. will be completed and accepted for review 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 the BLA for BNT162b2 in the U.S. and any 
other applications that may be pending or filed for BNT162b2 (including 
any requested amendments to the emergency use or conditional marketing 
authorizations) 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, clinical trial sites or third-party suppliers; the risk that 
demand for any products may be reduced or no longer exist; 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, booster doses or new 
variant-specific vaccines; 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 advisory or technical committees and 
other public health authorities and uncertainties regarding the 
commercial impact of any such recommendations; challenges related to 
public vaccine confidence or awareness; 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 
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www.sec.gov and 
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www.pfizer.com. 
 
   About BioNTech 
 
   Biopharmaceutical 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 Statements 
 
   This 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); the potential of BNT162b2 for adolescents 12 to 
15 years of age, evaluation of BNT162b2 in children 6 months to 11 years 
old, anticipated timing of regulatory submissions, regulatory approvals 
or authorizations, including the Biologics License Application, and 
anticipated manufacturing, distribution and supply; 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, 

(MORE TO FOLLOW) Dow Jones Newswires

May 07, 2021 06:45 ET (10:45 GMT)

Stocks mentioned in the article
ChangeLast1st jan.
BAYER AG -0.49% 53.21 Delayed Quote.10.50%
BIONTECH SE -7.53% 220.58 Delayed Quote.170.58%
DJ INDUSTRIAL -0.25% 34393.75 Delayed Quote.12.65%
FACEBOOK INC 1.66% 336.77 Delayed Quote.23.29%
GENMAB A/S 2.04% 2703 Delayed Quote.7.55%
PFIZER, INC. -1.30% 39.63 Delayed Quote.7.66%
SANOFI -0.01% 88.89 Real-time Quote.12.95%
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Financials
Sales 2021 12 357 M 14 977 M 14 977 M
Net income 2021 6 910 M 8 375 M 8 375 M
Net cash 2021 7 694 M 9 324 M 9 324 M
P/E ratio 2021 7,64x
Yield 2021 -
Capitalization 57 615 M 57 615 M 69 827 M
EV / Sales 2021 4,04x
EV / Sales 2022 4,34x
Nbr of Employees 2 200
Free-Float 87,3%
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Mean consensus OUTPERFORM
Number of Analysts 13
Average target price 145,96 €
Last Close Price 220,58 €
Spread / Highest target -9,91%
Spread / Average Target -33,8%
Spread / Lowest Target -58,6%
EPS Revisions
Managers and Directors
NameTitle
Ugur Sahin Chief Executive Officer
Sierk P÷tting Chief Operating & Financial Officer
Helmut Jeggle Chairman-Supervisory Board
Ízlem TŘreci Chief Medical Officer
Christoph Huber Member-Supervisory Board
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