Update Regarding Pfizer’s Statement on COMIRNATY-Related Write-Offs
16 10월 2023 - 4:00PM
Update Regarding Pfizer’s Statement on COMIRNATY-Related Write-Offs
MAINZ, Germany, October 16, 2023 (GLOBE
NEWSWIRE) -- On October 13, 2023, Pfizer Inc. (NYSE: PFE,
“Pfizer”), a collaboration partner of BioNTech SE (Nasdaq: BNTX,
“BioNTech” or “the Company”), announced a non-cash charge for
inventory write-offs and other charges related to COMIRNATY of $0.9
billion. The Company has been informed by Pfizer that the majority
of the write-offs relate to raw materials, mainly
formulation-related lipids, purchased during the pandemic, as well
as COVID-19 vaccine doses adapted to other, non-XBB.1.5 variants
produced at risk. According to Pfizer, the write-offs do not
address Pfizer-BioNTech COVID-19 Vaccine doses adapted to the
XBB.1.5 variant, which has been approved and is being marketed in
key geographies.
BioNTech is evaluating the potential impact of
Pfizer’s write-offs and other charges related to COMIRNATY on the
Company’s financial results. BioNTech’s current expectation is that
the Company is likely to recognize the effect of Pfizer’s inventory
write-offs and other charges related to COMIRNATY in the third
quarter of 2023 up to €0.9 billion, which represents BioNTech’s
half of the gross profit-sharing agreement with Pfizer. Any such
write-offs will reduce the revenues the Company would report for
2023. BioNTech expects to release its financial report for the
third quarter of 2023 on November 6, 2023.
About BioNTechBiopharmaceutical New
Technologies (BioNTech) 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 (CAR) T cells,
several protein-based therapeutics, including bispecific immune
checkpoint modulators, targeted cancer antibodies and antibody-drug
conjugate (ADC) therapeutics, as well as 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 DualityBio, Fosun
Pharma, Genentech, a member of the Roche Group, Genevant, Genmab,
OncoC4, Regeneron, Sanofi, and Pfizer.
For more information, please visit
www.BioNTech.com
Forward-Looking StatementsThis press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, as amended,
including, but not limited to, statements concerning: BioNTech's
expected revenues and net profit related to sales of BioNTech's
COVID-19 vaccine, referred to as COMIRNATY where approved for
use under full or conditional marketing authorization, in
territories controlled by BioNTech's collaboration partners,
particularly for those figures that are derived from preliminary
estimates provided by BioNTech's partners; the impact and timing of
the impact of the Pfizer write-offs and other COMIRNATY-related
charges on BioNTech’s financial results; the rate and degree of
market acceptance of BioNTech's COVID-19 vaccine and, if approved,
BioNTech's investigational medicines; expectations regarding
anticipated changes in COVID-19 vaccine demand, including changes
to the ordering environment and expected regulatory recommendations
to adapt vaccines to address new variants or sublineages; and
BioNTech's estimates of commercial and other revenues, cost of
sales, research and development expenses, sales and marketing
expenses, general and administrative expenses, capital
expenditures, income taxes, net profit, cash, cash equivalents and
security investments, shares outstanding and cash outflows and
share consideration. In some cases, forward-looking statements can
be identified by terminology such as “will,” “may,” “should,”
“expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,”
“estimates,” “predicts,” “potential,” “continue,” or the negative
of these terms or other comparable terminology, although not all
forward-looking statements contain these words. The forward-looking
statements in this 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. These risks and uncertainties include, but are not
limited to: BioNTech's pricing and coverage negotiations with
governmental authorities, private health insurers and other
third-party payors after BioNTech's initial sales to national
governments; the future commercial demand and medical need for
initial or booster doses of a COVID-19 vaccine; competition from
other COVID-19 vaccines or related to BioNTech's other product
candidates, including those with different mechanisms of action and
different manufacturing and distribution constraints, on the basis
of, among other things, efficacy, cost, convenience of storage and
distribution, breadth of approved use, side-effect profile and
durability of immune response; the timing of and BioNTech's ability
to obtain and maintain regulatory approval for BioNTech's product
candidates; the ability of BioNTech’s COVID-19 vaccines to prevent
COVID-19 caused by emerging virus variants; BioNTech's and its
counterparties’ ability to manage and source necessary energy
resources; the impact of the COVID-19 pandemic on BioNTech's
development programs, supply chain, collaborators and financial
performance; unforeseen safety issues and potential claims that are
alleged to arise from the use of BioNTech's COVID-19 vaccine and
other products and product candidates developed or manufactured by
BioNTech; BioNTech's and its collaborators’ ability to
commercialize and market BioNTech's COVID-19 vaccine and, if
approved, its product candidates; BioNTech's ability to manage its
development and expansion; regulatory developments in the United
States and other countries; BioNTech's ability to effectively scale
BioNTech's production capabilities and manufacture BioNTech's
products, including BioNTech's target COVID-19 vaccine production
levels, and BioNTech's product candidates; risks relating to the
global financial system and markets; and other factors not known to
BioNTech at this time.
You should review the risks and uncertainties
described under the heading “Risk Factors” in BioNTech's Report on
Form 6-K for the period ended June 30, 2023 and in subsequent
filings made by BioNTech with the SEC, 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.
Contacts
Investor RelationsVictoria Meissner,
M.D.+1 617 528 8293Investors@biontech.de
Media RelationsJasmina Alatovic+49
(0)6131 9084 1513Media@biontech.de
BioNTech (TG:22UA)
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