- Expanded and advanced oncology pipeline to 20 programs in 24
ongoing clinical trials including five ongoing randomized Phase 2
clinical trials; multiple trials with registrational potential
expected to be initiated in 2023 and 2024
- Announced licensing agreement with OncoC4 to complement the
Company’s oncology portfolio with clinical stage next-generation
immune checkpoint modulator; a randomized Phase 3 trial planned to
start in 2023
- Initiated Phase 1 trials for four mRNA vaccine candidates in
the infectious disease field
- Approximately 2 billion doses of COMIRNATY® invoiced in 2022,
including approximately 550 million doses of Omicron-adapted
bivalent COVID-19 vaccines
- Fourth quarter and full year revenues of €4.3 billion1 and
€17.3 billion1, respectively
- Full year net profit of €9.4 billion and fully diluted earnings
per share of €37.77 ($39.77²)
- Strong liquidity of €13.9 billion cash and cash equivalents;
€1.8 billion gross profit share settlement was received in cash as
of January 12, 2023
- Expect to authorize a share repurchase program of up to $0.5
billion during the remainder of 2023
Conference call and webcast scheduled for
March 27 at 8:00 am ET (2:00 pm CET)
MAINZ, Germany, March 27, 2023 (GLOBE
NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or the
”Company”) today reported financial results for the three months
and full year ended December 31, 2022, and provided an update on
its corporate progress.
“We made significant progress in 2022 by
advancing our pipeline and launching the world’s first Omicron
BA.4/BA.5 adapted bivalent COVID-19 vaccine. In addition, multiple
new modalities achieved encouraging clinical data and we progressed
nine new programs into clinical trials,” said Prof. Ugur
Sahin, M.D., CEO and Co-Founder of BioNTech. “As we look to
2023 and beyond, we plan to continue investing in our
transformation with a focus on building commercial capabilities in
oncology and working towards registrational trials. Our mid-term
goal is to seek approval for multiple oncology products in cancer
indications with high unmet medical need.”
Financial Review for the Fourth Quarter and
Full Year 2022 Financial Results
in millions, except per share data |
Fourth Quarter 2022 |
Fourth Quarter 2021 |
Full Year 2022 |
Full Year 2021 |
Total Revenues1 |
€4,278.3 |
€5,532.5 |
€17,310.6 |
€18,976.7 |
Net Profit |
€2,278.7 |
€3,166.2 |
€9,434.4 |
€10,292.5 |
Diluted Earnings per Share |
€9.26 |
€12.18 |
€37.77 |
€39.63 |
Total revenues reported were €4,278.3
million1 for the three months ended December 31, 2022, compared to
€5,532.5 million1 for the comparative prior year period. For the
year ended December 31, 2022, total revenues were €17,310.6
million1, compared to €18,976.7 million1 for the comparative prior
year period. The change corresponds with the demand for COVID-19
vaccines.
Cost of sales were €183.5 million for the
three months ended December 31, 2022, compared to €583.2 million
for the comparative prior year period. For the year ended December
31, 2022, cost of sales were €2,995.0 million, compared to €2,911.5
million for the comparative prior year period. Cost of sales were
impacted by expenses arising from inventory write-offs and expenses
for production capacities derived from agreements with contract
manufacturing organizations that became redundant. In addition,
during the three months ended December 31, 2022, cost of sales were
impacted by the release of provisions.
Research and development expenses were
€509.8 million for the three months ended December 31, 2022,
compared to €271.5 million for the comparative prior year period.
For the year ended December 31, 2022, research and development
expenses were €1,537.0 million, compared to €949.2 million for the
comparative prior year period. The increase was mainly due to
expenses in connection with the development and production of
BioNTech’s and Pfizer’s Omicron-adapted bivalent COVID-19 vaccines
and from progressing the clinical studies for BioNTech’s pipeline
candidates. The increase was further driven by a higher headcount
in the R&D area and expenses incurred under BioNTech’s
share-based-payment arrangements.
General and administrative expenses were
€122.9 million for the three months ended December 31, 2022,
compared to €130.9 million for the comparative prior year period.
For the year ended December 31, 2022, general and administrative
expenses were €484.7 million, compared to €285.8 million for the
comparative prior year period. The increase was mainly due to
increased expenses for IT and purchased external services as well
as an increase in headcount.
Income taxes were accrued in an amount of
€893.9 million of tax expenses for the three months ended December
31, 2022, compared to €1,547.7 million of tax expenses for the
comparative prior year period. For the year ended December 31,
2022, income taxes accrued were €3,519.7 million of tax expenses,
compared to €4,753.9 million of tax expenses for the comparative
prior year period. The derived annual effective income tax rate for
the year ended December 31, 2022, was 27.2%.
Net profit was €2,278.7 million for the
three months ended December 31, 2022, compared to €3,166.2 million
for the comparative prior year period. For the year ended December
31, 2022, net profit was €9,434.4 million, compared to €10,292.5
million for the comparative prior year period.
Cash and cash equivalents were €13,875.1
million as of December 31, 2022. Subsequent to the end of the
reporting period, the payment settling BioNTech’s gross profit
share for the third quarter of 2022 (as defined by the contract) in
the amount of €1,816.5 million was received from our collaboration
partner as of January 12, 2023. The contractual settlement of the
gross profit share under the COVID-19 collaboration with Pfizer has
a temporal offset of more than one calendar quarter. As Pfizer’s
fiscal quarter for subsidiaries outside the United States differs
from BioNTech’s financial reporting cycle, it creates an additional
time lag between the recognition of revenues and the payment
receipt.
Shares Outstanding: Shares outstanding as
of December 31, 2022, were 243,215,169.
“Our COVID-19 vaccine revenues, driven by the
delivery of our Omicron-adapted bivalent vaccines, have ensured
another strong financial performance in 2022,” said Jens
Holstein, CFO of BioNTech. “We believe that the Company’s
financial success in 2022 will provide a springboard to accelerate
and build upon our diversified clinical pipeline and fuel our
research and development in the coming years. The announced
acquisition of InstaDeep and the recent license and collaboration
agreement with OncoC4, which adds a clinical program to our
existing portfolio aim to create future value for BioNTech mid- to
long-term. We anticipate our COVID-19 franchise will further
support our already existing financial strength in the years to
come. As a science and innovation driven company, we plan to
continue to invest heavily in R&D and are willing to invest in
mergers and acquisitions as well as collaborations to create future
growth for the Company.”
Outlook for the 2023 Financial Year:
The Company’s outlook contains the following
components: BioNTech COVID-19 Vaccine Revenues for the 2023
Financial Year:
Estimated BioNTech COVID-19 vaccine revenues for the 2023 financial
year |
~ €5 billion |
This revenue estimate reflects expected revenues
related to BioNTech’s share of gross profit from COVID-19 vaccine
sales in the collaboration partner’s territories, from direct
COVID-19 vaccine sales to customers in BioNTech’s territory and
expected revenues from sales to collaboration partners which may be
influenced by costs like inventory write-offs once materialized and
shared with the collaboration partner Pfizer. Revenue guidance is
based on various assumptions including but not limited to the
expected transition from an advanced purchase agreement environment
to commercial market ordering starting in 2023 and a regulatory
recommendation to adapt the COVID-19 vaccines to address newly
circulating variants or sublineages of SARS-CoV-2. The estimated
BioNTech COVID-19 vaccine revenues reflect expected deliveries
under existing or committed supply contracts and anticipated sales
through traditional commercial orders. A re-negotiation of the
existing supply contract with the European Commission is ongoing,
with the potential for a rephasing of deliveries of doses across
multiple years and/or a volume reduction. While a vaccine
adaptation is expected to lead to an increased demand, fewer
primary vaccinations and lowered population-wide levels of boosting
are anticipated. Seasonal demand is assumed, moving expected
revenue generation significantly to the second half of the year
2023.
Planned 2023 Financial Year Expenses and
Capex:
R&D expenses |
€2,400 million - €2,600 million |
SG&A expenses |
€650 million - €750 million |
Capital expenditures |
€500 million - €600 million |
Estimated 2023 Financial Year Tax Assumptions:
BioNTech Group estimated annual cash effective income tax rate |
~27% |
Numbers reflect current base case projections,
include potential effects caused or driven by additional
collaborations or potential M&A transactions to the extent they
have been disclosed and are calculated based on constant currency
rates.
Operational Review of the Fourth Quarter and Key Post
Period-End Events
COVID-19 Vaccine Programs – BNT162 (COMIRNATY)
Commercial updates
- In December 2022, BioNTech and Pfizer announced that
approximately 2 billion doses of COMIRNATY were invoiced globally
in 2022 between the two companies, including approximately 550
million doses of the Original/Omicron BA.4-5-adapted bivalent
COVID-19 vaccine, as of mid-December 2022.
- In January 2023, BioNTech and Pfizer announced that
negotiations were ongoing for the re-phasing of delivery timelines
for the COMIRNATY supply agreement with the European Commission
(EC). The agreement with the EC was signed in May 2021 and a
rephasing agreement was previously reached in May 2022.
- As part of BioNTech’s and Pfizer's 2-billion-doses-pledge to
support equitable access to medicines, the companies have delivered
approximately 1.7 billion doses of COMIRNATY to low- and
middle-income countries in line with demand. The deliveries include
both the Original/Omicron BA.4-5-adapted bivalent COVID-19 vaccine
and the original COVID-19 vaccine.
Clinical development and regulatory updates
Original COVID-19 vaccine
- In October 2022, BioNTech and Pfizer received EC approval for
the conversion of the conditional Marketing Authorization (CMA) to
full Marketing Authorization (MA). The conversion applies to all
existing indications and formulations of the COMIRNATY product
group authorized in the European Union, including Original/Omicron
BA.1- and BA.4-5-adapted bivalent COVID-19 vaccines as booster
doses for individuals aged 12 years and older.
- In October 2022, BioNTech and Pfizer received EC approval for
full MA for a 3-µg dose of the original COVID-19 vaccine as a
three-dose series for children aged six months through four
years.
- In October 2022, BioNTech and Pfizer received EC approval for a
fourth dose booster of the original COVID-19 vaccine in individuals
12 years of age and older at an interval of at least three months
between the administration of the original COVID-19 vaccine and the
last prior dose of a COVID-19 vaccine.
Original/Omicron BA.4-5-adapted bivalent
COVID-19 vaccine booster
- In the second half of 2022, BioNTech and Pfizer received
approval or authorization of a 30-µg booster dose of the
Original/Omicron BA.4-5-adapted bivalent COVID-19 vaccine for
individuals aged 12 years and older, granted by the U.S. Food and
Drug Administration (FDA) (August), European Commission (EC)
(September), Health Canada (October), and Health Bureau of the Hong
Kong Special Administrative Region of the People's Republic of
China (November). The Original/Omicron BA.4-5-adapted bivalent
COVID-19 vaccine was approved or authorized for use in more than 65
countries and regions in 2022. Authorization of a 10-µg booster
dose of Original/Omicron BA.4-5-adapted bivalent COVID-19 vaccine
in children five through 11 years of age was granted by U.S. FDA
(EUA) (October) and EC (November).
- In November 2022, BioNTech and Pfizer reported updated 30-day
clinical data from the randomized Phase 2/3 clinical trial
evaluating the safety, tolerability and immunogenicity of the
companies’ Original/Omicron BA.4-5-adapted bivalent COVID-19
vaccine, given as a 30-µg booster dose. The data demonstrated a
robust and broadly neutralizing immune response one month after a
30-µg booster dose. There was a substantially higher increase in
Omicron BA.4/BA.5-neutralizing antibody titers compared to
pre-booster levels for those who received the bivalent vaccine
compared to the original COVID-19 vaccine, with similar favorable
safety and tolerability profile demonstrated between both
vaccines.
- In November 2022, BioNTech and Pfizer announced results from an
analysis examining the immune response induced by the
Original/Omicron BA.4-5-adapted bivalent COVID-19 vaccine against
newer Omicron sublineages with enhanced escape mechanisms,
including BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1. The published data
(Zou et al. Neutralization of BA.4–BA.5, BA.4.6, BA.2.75.2, BQ.1.1,
and XBB.1 with Bivalent Vaccine; N Engl J Med 2023; 388:854-857)
indicated that the bivalent vaccine elicits a greater increase in
neutralizing antibody titers than the original COVID-19 vaccine
against these emerging Omicron sublineages.
- In December 2022, BioNTech and Pfizer received U.S. FDA EUA for
their Original/Omicron BA.4-5-adapted bivalent COVID-19 vaccine as
the third 3-µg dose in the three-dose primary series for children
six months through four years of age.
Next-generation COVID-19 vaccine
- In November 2022, BioNTech and Pfizer initiated a Phase 1
clinical trial to evaluate the safety, tolerability and
immunogenicity of BNT162b4, a next-generation COVID-19 vaccine
candidate that aims to enhance SARS-CoV-2 T cell responses and
potentially broaden protection against upcoming variants and
increase durability of protection.
COVID-19 – Influenza Combination mRNA Vaccine
Program (BNT162b2 + BNT161)
- In October 2022, BioNTech and Pfizer initiated a Phase 1
open-label, dose-finding clinical trial to evaluate the safety,
tolerability and immunogenicity of a combination of the COVID-19
and influenza mRNA vaccines to help protect individuals against
influenza and COVID-19 with a single injection. A data update from
this trial is expected in 2023.
- In December, BioNTech and Pfizer received Fast Track
Designation from the U.S. FDA for their mRNA-based combination
vaccine candidate.
Fourth Quarter 2022 Infectious Disease
Pipeline Update and Outlook
HSV-2 Vaccine Program –
BNT163
- In December 2022, BioNTech initiated a Phase 1 clinical trial
of BNT163, a herpes simplex virus (HSV) vaccine candidate for the
prevention of genital lesions caused by HSV-2 and potentially
HSV-1. The trial will evaluate the safety, tolerability and
immunogenicity of BNT163. A data update is expected in 2H
2023.
Malaria Vaccine Program –
BNT165
- In December 2022, BioNTech initiated a Phase 1 clinical trial
of BNT165b1, the first candidate from the Company’s BNT165 program
to develop a multi-antigen malaria vaccine candidate. This first
clinical trial (NCT05581641) will evaluate the safety, tolerability
and exploratory immunogenicity of the vaccine candidate. A data
update is expected in 2H 2023.
Shingles Vaccine Program –
BNT167
- In February 2023, BioNTech and Pfizer initiated a randomized
controlled, dose-selection Phase 1/2 clinical trial of BNT167, the
companies’ mRNA vaccine candidates against shingles (also known as
herpes zoster). The clinical trial (NCT05703607) will evaluate the
safety, tolerability, and immunogenicity of mRNA vaccine candidates
against shingles. A data update is expected in 2023.
Fourth Quarter 2022 Oncology Pipeline Update
and Outlook
- In 2022, BioNTech started five first-in-human clinical
trials:
- BNT116, a FixVac program for non-small cell lung cancer
(NSCLC),
- BNT141 and BNT142, two RiboMabs for CLDN18.2-positive and
CLDN6-positive solid tumors and
- BNT313, a HexaBody targeting CD27, and BNT322 (undisclosed
target), two new antibody candidates from its collaboration with
Genmab being evaluated in solid tumors.
BNT113, a candidate based on BioNTech’s
FixVac off-the-shelf mRNA-based cancer immunotherapy
approach, is being developed as a first-line treatment for
patients with unresectable recurrent or metastatic HPV16+ head and
neck squamous cell carcinoma, or HNSCC, expressing PD-L1. BNT113
has not previously been combined with anti-PD1 therapy.
- In December 2022, BioNTech presented preliminary safety data
from the run-in portion (Part A) of the ongoing Phase 2 trial
designed to demonstrate the safety of the combination of BNT113 and
pembrolizumab at the annual European Society for Medical Oncology
(ESMO) Immuno-Oncology Congress. As of July 5, 2022, of 15 treated
patients, 12 had completed the safety run-in (pembrolizumab + four
BNT113 doses). Data showed safety was acceptable and in line with
the safety profile of BNT113 and pembrolizumab as single agents; no
new safety signals were observed for the combination. The
randomized Part B is ongoing.
Autogene cevumeran (BNT122) is a
candidate based on an individualized neoantigen-specific
immunotherapy (iNeST) approach developed for the treatment of
adjuvant and metastatic cancers in collaboration with Genentech, a
member of the Roche Group. Each autogene cevumeran dose
includes up to 20 different neoantigens selected on a
patient-by-patient basis.
- In 2023, BioNTech and Genentech are expecting a data update
from an ongoing open-label Phase 2 trial evaluating the efficacy
and safety of autogene cevumeran in combination with pembrolizumab
versus pembrolizumab alone in patients with previously untreated
advanced melanoma.
- A Phase 2 clinical trial of autogene cevumeran in the adjuvant
setting in patients with pancreatic ductal adenocarcinoma (PDAC) is
planned to open in 2023.
BNT211 is a chimeric antigen receptor
(CAR) directing T cells against the novel target CLDN6 that
is tested alone and in combination with a CAR-T cell Amplifying RNA
Vaccine, or CARVac, encoding CLDN6. CARVac is intended to drive in
vivo expansion of transferred CAR-T cells to increase their
persistence and efficacy.
- In 2023, BioNTech expects to provide a data update on the
ongoing Phase 1/2 dose escalation and expansion, evaluating CLDN6
CAR-T cells with or without CLDN6 CARVac in patients with
CLDN6-positive relapsed or refractory advanced solid tumors.
- In September 2022, BioNTech provided a data update from the
ongoing study at the ESMO Congress, which demonstrated signs of
anti-tumor activity and a manageable safety profile across both
dose levels. An efficacy assessment of 21 evaluable patients showed
an overall response rate, or ORR, of 33% and a disease control
rate, or DCR, of 67% with one complete response, six partial
responses and seven patients with stable disease. Particularly
encouraging clinical responses were seen in patients with
testicular cancer treated with dose level 2 after lymphodepletion
(n=7), where one complete response, three partial responses and two
stable diseases were observed, representing an ORR of 57% and a DCR
of 85%.
- The Company expects a Phase 2 study of BNT211 in patients with
2L+ platinum resistant testicular cancer to start in 2024.
BNT312 (GEN1042) is a first-in-class
bispecific antibody candidate designed to induce
conditional immune activation by crosslinking CD40 and 4-1BB
positive cells.
- In December 2022, BioNTech and Genmab presented updated data
from the safety run-in and expansion cohorts of the Phase 1/2 study
of BNT312 combination therapy at the ESMO Immuno-Oncology Annual
Congress. The data demonstrated that BNT312 + pembrolizumab (PEM) ±
chemotherapy (CTx) was well tolerated with no reported
dose-limiting toxicity. Most adverse events were grade 1/2 and
manageable. BNT312 (GEN1042) + PEM + CTx showed encouraging early
activity in patients with advanced/metastatic HNSCC, with responses
observed in 4/4 evaluable patients. The observed immune activity
mediated by BNT312 retained with combination
therapy. Enrollment in this trial is ongoing in all cohorts
(NSCLC, pancreatic ductal adenocarcinoma, and HNSCC).
BNT313 (GEN1053) is a
monospecific antibody candidate targeting CD27 to address
malignant solid tumors. It is based on Genmab's HexaBody technology
and is engineered to induce clustering of CD27 on the plasma
membrane of T cells with the aim of enhancing T cell activation,
proliferation and differentiation without depleting T cells.
- In November 2022, the Company initiated a Phase 1 clinical
trial to evaluate the safety, tolerability and preliminary efficacy
of BNT313 for the treatment of malignant solid tumors.
- Preclinical data characterizing the mechanism of action of
BNT313 were presented at the 37th Annual Meeting of the Society for
Immunotherapy of Cancer (SITC) in November 2022. In the in vitro
experiments, BNT313 exhibited CD27 agonist activity independently
of Fc gamma receptor-mediated crosslinking. BNT313 enhanced
activation, proliferation and proinflammatory cytokine secretion of
human CD4+ and CD8+ T cells as well as CD8+ T cell mediated
cytotoxic activity towards tumor cells in vitro. In mice expressing
human CD27 protein, it enhanced expansion and IFN-γ secretion of
antigen-specific CD8+ T cells in vivo. Overall, the data supported
a mechanism of action that distinguishes BNT313 from benchmark
monoclonal antibodies targeting CD27.
Fourth Quarter 2022 and Subsequent Corporate
Updates
- In November 2022, BioNTech’s affiliate BioNTech Pharmaceuticals
Asia Pacific Pte. Ltd. announced the signing of an agreement to
acquire a GMP-certified manufacturing facility in Singapore which
is planned to also serve as BioNTech’s Regional Headquarters.
- In November 2022, BioNTech entered a multi-target research
collaboration with Ryvu Therapeutics S.A. to develop and
commercialize immunomodulatory small molecule candidates as well as
standalone small molecules from Ryvu’s STING agonist
portfolio.
- In November 2022, the second tranche of BioNTech’s share
repurchase program of American Depositary Shares (ADSs) was
authorized, with a value of up to $0.5 billion, commencing on
December 7, 2022 and ending on March 17, 2023. In total, under both
tranches of the share repurchase program, 9,166,684 ADSs were
repurchased at an average price of $142.04, for a total
consideration of approximately $1.3 billion
(€1,268.4 million).
- As of December 31, 2022, BioNTech had share capital registered
in the commercial register (“Handelsregister”) in the amount of
€248,552,200, which was divided into 248,552,200 registered shares
(“Namensaktien”), including an amount of €5,337,031 relating to
1,548,439 ordinary shares held in the form of ADSs and 3,788,592
ordinary shares, each held in treasury.
- In December 2022, BioNTech announced that the first six
ISO-sized shipping containers for the BioNTainer have been
completed in Europe, underwent quality checks by BioNTech experts
and were being prepared for shipment to Kigali. The containers
subsequently arrived in March 2023.
- In January 2023, BioNTech announced that it had entered into an
agreement to acquire its long-standing strategic collaboration
partner InstaDeep Ltd., enabling the creation of a fully
integrated, enterprise-wide capability that leverages artificial
intelligence (AI) and machine learning (ML) technologies across
BioNTech’s therapeutic platforms and operations. The transaction is
expected to add approximately 240 highly skilled professionals to
BioNTech’s workforce, including teams in AI, ML, bioengineering,
data science, and software development.
- In February 2023, BioNTech completed the construction of its
first proprietary plasmid DNA manufacturing facility in
Marburg.
- In March 2023, BioNTech entered into an exclusive worldwide
licensing agreement with OncoC4, Inc. to co-develop and
commercialize ONC-392, an anti-CTLA-4 monoclonal antibody as
monotherapy or combination therapy in various cancer indications.
The companies plan to start a Phase 3 trial (NCT05671510) of
ONC-392 as monotherapy treatment in NSCLC patients who progress
after PD-1/PD-L1 treatment in 2023. The transaction is expected to
close in the first half of 2023, subject to customary closing
conditions and regulatory clearance.
Environmental, Social, and Governance (ESG)
overview
- BioNTech published its ESG report (Sustainability Report 2022)
on March 27, 2023. The report can be found in the Investor
Relations section of BioNTech’s website.
Upcoming investor and analyst events
- The Annual General Meeting is scheduled for May 25, 2023.
- BioNTech expects to host an Innovation Series Day on November
7, 2023.
Endnotes
The full audited consolidated financial
statements can be found in BioNTech’s Annual Report on Form 20-F
for the year ended December 31, 2022, filed with the SEC and
available at https://www.sec.gov/ (the “Annual Report”).1
BioNTech’s profit share is estimated based on preliminary data
shared between Pfizer and BioNTech as further described in the
Annual Report. Any changes in the estimated share of the
collaboration partner’s gross profit will be recognized
prospectively.² Calculated applying the average foreign exchange
rate for the year ended December 31, 2022 as published by the
German Central Bank (Deutsche Bundesbank).
Conference Call and Webcast
InformationBioNTech invites investors and the general public to
join a conference call and webcast with investment analysts on
March 27, 2023 at 8.00 a.m. EDT (2.00 p.m. CEST) to report its
financial results and provide a corporate update for the fourth
quarter and financial year 2022.To access the live conference call
via telephone, please register via this link. Once registered,
dial-in numbers and a pin number will be provided.
The slide presentation and audio of the webcast
will be available via this link.
Participants may also access the slides and the
webcast of the conference call via the “Events & Presentations”
page of the Investor Relations section of the Company’s website
at https://biontech.com/. A replay of the webcast will be
available shortly after the conclusion of the call and archived on
the Company’s website for 30 days following the call.
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 T cells, bispecific
immune checkpoint 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, Genentech, a member of the Roche Group, Regeneron,
Genevant, Fosun Pharma 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 rate and degree of
market acceptance of BioNTech's COVID-19 vaccine and, if approved,
BioNTech's investigational medicines; the initiation, timing,
progress, results, and cost of BioNTech's research and development
programs, including those relating to additional formulations of
BioNTech's COVID-19 vaccine, and BioNTech's current and future
preclinical studies and clinical trials, including statements
regarding the timing of initiation and completion of studies or
trials and related preparatory work and the availability of
results; the timing and expected impact of the Company’s planned
acquisition of InstaDeep Ltd. and collaboration and licensing
agreements with OncoC4, Inc. and others; the development of
sustainable vaccine production and supply solutions, including
BioNTainers, and the nature and feasibility of these solutions; and
BioNTech's estimates of commercial and other revenues, cost of
sales, research and development expenses, sales and marketing
expenses, general and administrative expenses, capital
expenditures, income taxes, and shares outstanding. 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
vaccine to prevent COVID-19 caused by emerging virus variants;
BioNTech's and its counterparties’ ability to manage and
source necessary energy resources; BioNTech's ability to identify
research opportunities and discover and develop investigational
medicines; the ability and willingness of BioNTech's third-party
collaborators to continue research and development activities
relating to BioNTech's development candidates and investigational
medicines; the impact of the COVID-19 pandemic on BioNTech's
development programs, supply chain, collaborators and financial
performance; unforeseen safety issues and claims for
potential personal injury or death arising from the use of
BioNTech's COVID-19 vaccine and other products and product
candidates developed or manufactured by BioNTech; BioNTech's and
its collaborators’ ability to commercialize and market BioNTech's
COVID-19 vaccine and, if approved, its product candidates;
BioNTech's ability to manage its development and expansion;
regulatory developments in the United States and foreign 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 Annual Report on Form 20-F for the year ended December
31, 2022 and in subsequent filings made by BioNTech with the SEC,
which are available on the SEC’s website
at https://www.sec.gov/. Except as required by law, BioNTech
disclaims any intention or responsibility for updating or revising
any forward-looking statements contained in this 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. BioNTech
ContactsInvestor Relations Michael Horowicz +1
(617) 955 7420 Investors@biontech.de
Media Relations Jasmina Alatovic +49 (0)6131 9084 1513
Media@biontech.de
Statements of Profit or Loss
|
Three months ended December 31, |
Years ended December 31, |
|
2022 |
2021 |
2022 |
2021 |
2020 |
(in millions, except per share data) |
(unaudited) |
(unaudited) |
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
|
|
Commercial revenues |
€4,271.3 |
€5,525.9 |
€17,194.6 |
€18,874.0 |
€303.5 |
Research & development revenues |
7.0 |
6.6 |
116.0 |
102.7 |
178.8 |
Total revenues |
€4,278.3 |
€5,532.5 |
€17,310.6 |
€18,976.7 |
€482.3 |
|
|
|
|
|
|
Cost of sales |
(183.5) |
(583.2) |
(2,995.0) |
(2,911.5) |
(59.3) |
Research and
development expenses |
(509.8) |
(271.5) |
(1,537.0) |
(949.2) |
(645.0) |
Sales and marketing
expenses |
(14.6) |
(17.9) |
(59.5) |
(50.4) |
(14.5) |
General and
administrative expenses |
(122.9) |
(130.9) |
(484.7) |
(285.8) |
(94.0) |
Other operating
expenses |
(376.2) |
(67.1) |
(407.0) |
(94.4) |
(2.4) |
Other operating
income |
221.6 |
237.8 |
815.3 |
598.4 |
250.5 |
Operating income / (loss) |
€3,292.9 |
€4,699.7 |
€12,642.7 |
€15,283.8 |
€(82.4) |
|
|
|
|
|
|
Finance income |
38.8 |
16.3 |
330.3 |
67.7 |
1.6 |
Finance
expenses |
(159.1) |
(2.1) |
(18.9) |
(305.1) |
(65.0) |
Profit / (loss) before tax |
€3,172.6 |
€4,713.9 |
€12,954.1 |
€15,046.4 |
€(145.8) |
|
|
|
|
|
|
Income taxes |
(893.9) |
(1,547.7) |
(3,519.7) |
(4,753.9) |
161.0 |
Profit for the
period |
€2,278.7 |
€3,166.2 |
€9,434.4 |
€10,292.5 |
€15.2 |
|
|
|
|
|
|
Earnings per
share |
|
|
|
|
|
Basic profit for the
period per share |
€9.38 |
€12.96 |
€38.78 |
€42.18 |
€0.06 |
Diluted profit for the period per share |
€9.26 |
€12.18 |
€37.77 |
€39.63 |
€0.06 |
Statements of Financial Position
|
|
|
December 31, |
December 31, |
(in
millions) |
|
|
2022 |
2021 |
Assets |
|
|
|
|
Non-current assets |
|
|
|
|
Intangible assets |
|
|
€219.7 |
€202.4 |
Property, plant and equipment |
|
|
609.2 |
322.5 |
Right-of-use assets |
|
|
211.9 |
197.9 |
Other financial assets |
|
|
80.2 |
21.3 |
Other non-financial assets |
|
|
6.5 |
14.4 |
Deferred tax assets |
|
|
229.6 |
— |
Total non-current assets |
|
|
€1,357.1 |
€758.5 |
Current assets |
|
|
|
|
Inventories |
|
|
439.6 |
502.5 |
Trade and other receivables |
|
|
7,145.6 |
12,381.7 |
Other financial assets |
|
|
189.4 |
381.6 |
Other non-financial assets |
|
|
271.9 |
113.4 |
Income tax assets |
|
|
0.4 |
0.4 |
Cash and cash equivalents |
|
|
13,875.1 |
1,692.7 |
Total current assets |
|
|
€21,922.0 |
€15,072.3 |
Total assets |
|
|
€23,279.1 |
€15,830.8 |
|
|
|
|
|
Equity and liabilities |
|
|
|
|
Equity |
|
|
|
|
Share capital |
|
|
248.6 |
246.3 |
Capital reserve |
|
|
1,828.2 |
1,674.4 |
Treasury shares |
|
|
(5.3) |
(3.8) |
Retained earnings |
|
|
18,833.0 |
9,882.9 |
Other reserves |
|
|
(848.9) |
93.9 |
Total equity |
|
|
€20,055.6 |
€11,893.7 |
Non-current liabilities |
|
|
|
|
Lease liabilities, loans and
borrowings |
|
|
176.2 |
171.6 |
Other financial liabilities |
|
|
6.1 |
6.1 |
Income tax liabilities |
|
|
10.4 |
4.4 |
Provisions |
|
|
8.6 |
184.9 |
Contract liabilities |
|
|
48.4 |
9.0 |
Other non-financial liabilities |
|
|
17.0 |
12.8 |
Deferred tax liabilities |
|
|
6.2 |
66.7 |
Total non-current liabilities |
|
|
€272.9 |
€455.5 |
Current liabilities |
|
|
|
|
Lease liabilities, loans and
borrowings |
|
|
36.0 |
129.9 |
Trade payables |
|
|
204.1 |
160.0 |
Other financial liabilities |
|
|
785.1 |
1,190.4 |
Refund liabilities |
|
|
24.4 |
90.0 |
Income tax liabilities |
|
|
595.9 |
1,568.9 |
Provisions |
|
|
367.2 |
110.2 |
Contract liabilities |
|
|
77.1 |
186.1 |
Other
non-financial liabilities |
|
|
860.8 |
46.1 |
Total current liabilities |
|
|
€2,950.6 |
€3,481.6 |
Total liabilities |
|
|
€3,223.5 |
€3,937.1 |
Total equity and liabilities |
|
|
€23,279.1 |
€15,830.8 |
Statements of Cash Flows
|
|
Three months ended December 31, |
Years ended December 31, |
|
|
2022 |
2021 |
2022 |
2021 |
2020 |
(in millions) |
|
(unaudited) |
(unaudited) |
|
|
|
Operating activities |
|
|
|
|
|
|
Profit for the period |
|
€2,278.7 |
€3,166.2 |
€9,434.4 |
€10,292.5 |
€15.2 |
Income
taxes |
|
893.9 |
1,547.7 |
3,519.7 |
4,753.9 |
(161.0) |
Profit before tax |
|
€3,172.6 |
€4,713.9 |
€12,954.1 |
€15,046.4 |
€(145.8) |
Adjustments to reconcile profit before
tax to net cash flows: |
|
|
|
|
|
|
Depreciation and amortization of
property, plant, equipment, intangible assets and right-of-use
assets |
|
29.0 |
26.0 |
123.3 |
75.2 |
38.7 |
Share-based payment expenses |
|
19.4 |
20.5 |
108.6 |
93.9 |
32.1 |
Net foreign exchange differences |
|
847.8 |
(92.0) |
625.5 |
(387.5) |
41.3 |
Loss on disposal of property, plant and
equipment |
|
0.2 |
4.2 |
0.6 |
4.6 |
0.6 |
Finance income excluding foreign
exchange differences |
|
(38.8) |
(0.3) |
(265.3) |
(1.5) |
(1.6) |
Finance expense excluding foreign
exchange differences |
|
2.1 |
2.2 |
18.9 |
305.2 |
22.3 |
Movements in government grants |
|
0.3 |
20.6 |
0.3 |
(89.0) |
92.0 |
Other non-cash income / (loss) |
|
— |
(2.2) |
— |
(2.2) |
1.7 |
Unrealized net (gain) / loss on
derivative instruments at fair value through profit or loss |
|
(323.3) |
32.4 |
(241.0) |
57.3 |
— |
Working capital adjustments: |
|
|
|
|
|
|
Decrease / (increase) in trade and
other receivables, contract assets and other assets |
|
(646.8) |
(1,712.7) |
4,369.9 |
(11,808.1) |
(247.9) |
Decrease / (increase) in
inventories |
|
(144.8) |
(109.1) |
62.9 |
(438.4) |
(49.8) |
Increase in trade payables, other
financial liabilities, other liabilities, contract liabilities,
refund liabilities and provisions |
|
(674.6) |
362.2 |
85.7 |
1,516.1 |
204.6 |
Interest received |
|
22.8 |
0.2 |
29.3 |
1.2 |
1.4 |
Interest paid |
|
(5.0) |
(6.1) |
(21.5) |
(12.2) |
(3.6) |
Income tax received / (paid), net |
|
(1,387.4) |
(3,456.9) |
(4,222.1) |
(3,457.9) |
0.5 |
Share-based payments |
|
(44.3) |
(2.4) |
(51.8) |
(13.4) |
— |
Net
cash flows from / (used in) operating activities |
|
€829.2 |
€(199.5) |
€13,577.4 |
€889.7 |
€(13.5) |
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
Purchase of property, plant and
equipment |
|
(136.6) |
(39.4) |
(329.2) |
(127.5) |
(66.0) |
Proceeds from sale of property, plant
and equipment |
|
0.2 |
2.0 |
0.6 |
3.4 |
1.2 |
Purchase of intangible assets and
right-of-use assets |
|
(7.9) |
(14.0) |
(34.1) |
(26.5) |
(19.4) |
Acquisition of subsidiaries and
businesses, net of cash acquired |
|
— |
(20.8) |
— |
(20.8) |
(60.6) |
Purchase of financial instruments |
|
(16.7) |
(19.5) |
(47.8) |
(19.5) |
— |
(Investment) / proceeds from maturity
of other financial assets |
|
— |
(8.2) |
375.2 |
(375.2) |
— |
Net cash flows used in investing activities |
|
€(161.0) |
€(99.9) |
€(35.3) |
€(566.1) |
€(144.8) |
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
Proceeds from issuance of share capital
and treasury shares, net of costs |
|
— |
— |
110.5 |
160.9 |
753.0 |
Proceeds from loans and borrowings |
|
0.2 |
— |
0.8 |
— |
156.0 |
Repayment of loans and borrowings |
|
— |
(50.7) |
(18.8) |
(52.6) |
(1.6) |
Payments related to lease
liabilities |
|
(9.2) |
1.8 |
(41.1) |
(14.1) |
(12.7) |
Share repurchase program |
|
(55.7) |
— |
(986.4) |
— |
— |
Dividends |
|
— |
— |
(484.3) |
— |
— |
Net
cash flows from / (used in) financing activities |
|
€(64.7) |
€(48.9) |
€(1,419.3) |
€94.2 |
€894.7 |
|
|
|
|
|
|
|
Net increase in cash and cash
equivalents |
|
603.5 |
(348.3) |
12,122.8 |
417.8 |
736.4 |
Change in cash and cash equivalents
resulting from exchange rate differences |
|
(152.1) |
15.3 |
59.6 |
64.7 |
(45.3) |
Cash
and cash equivalents at the beginning of the period |
|
13,423.7 |
2,025.7 |
1,692.7 |
1,210.2 |
519.1 |
Cash and cash equivalents at December 31 |
|
€13,875.1 |
€1,692.7 |
€13,875.1 |
€1,692.7 |
€1,210.2 |
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