BioNTech Announces Second Quarter 2023 Financial Results and
Corporate Update
- Significant pipeline advancement highlighted by the initiation
of BNT316/ONC-392 Phase 3 pivotal trial and multiple trials planned
to start across the oncology portfolio
- Positive data updates across multiple technology platforms
including ADC candidate BNT323/DB-1303, anti-CTLA4 monoclonal
antibody candidate BNT316/ONC-392 and CAR-T candidate BNT211
- Preparation for launch of Omicron XBB.1.5-adapted monovalent
COVID-19 vaccine as recommended by the U.S. Food and Drug
Administration (FDA), European Medicines Agency (EMA) and other
health authorities; deliveries expected to start as early as
September, subject to regulatory approval
- Reiterates COVID-19 vaccine revenue guidance of approximately
€5 billion in 2023
- First half1 of 2023 revenues of €1.4 billion2, net profit
of €311.8 million and fully diluted earnings per share of €1.28
($1.383)
Conference call and webcast scheduled for
August 7, 2023, at 8:00 am EDT (2:00 pm CEST)
MAINZ, Germany, August 7, 2023 (GLOBE
NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the
Company”) today reported financial results for the three and six
months ended June 30, 2023, and provided an update on its corporate
progress.
“We are progressing our oncology pipeline into
late-stage development, having launched a pivotal Phase 3 trial and
preparing for additional trials with registrational potential in
the coming months,” said Prof. Ugur Sahin, M.D., CEO and
Co-Founder of BioNTech. “Simultaneously, we are enhancing our
infectious disease pipeline to address global health needs and are
developing an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine
to become available for the upcoming fall-winter season, subject to
regulatory approvals.”
Financial Review for the Second Quarter and
First Half of 2023
in millions €, except per share data |
Second Quarter 2023 |
Second Quarter 2022 |
First Half 2023 |
First Half 2022 |
Total Revenues2 |
167.7 |
3,196.5 |
1,444.7 |
9,571.1 |
Net Profit / (Loss) |
(190.4) |
1,672.0 |
311.8 |
5,370.8 |
Diluted Earnings / (Loss) per Share |
(0.79) |
6.45 |
1.28 |
20.69 |
Total revenues reported were €167.7
million2 for the three months ended June 30, 2023, compared to
€3,196.5 million for the comparative prior year period. For
the six months ended June 30, 2023, total revenues were
€1,444.7 million2, compared to €9,571.1 million for the comparative
prior year period. Write-offs by BioNTech’s collaboration partner
Pfizer, Inc. (“Pfizer”) significantly reduced the Company’s gross
profit share in the second quarter and hence negatively influenced
its revenues for the three months ended June 30, 2023.
Cost of sales were €162.9 million for the
three months ended June 30, 2023, compared to
€764.6 million for the comparative prior year period. For the
six months ended June 30, 2023, cost of sales were €258.9
million, compared to €2,058.7 million for the comparative prior
year period. The change was in line with decreasing COVID-19
vaccine sales.
Research and development expenses were
€373.4 million for the three months ended June 30, 2023,
compared to €399.6 million for the comparative prior year period.
For the six months ended June 30, 2023, research and
development expenses were €707.4 million, compared to
€685.4 million for the comparative prior year period. Research
and Development (R&D) expenses are mainly influenced by
progressing clinical studies for pipeline candidates, the
development of variant adapted as well as next generation COVID-19
vaccines and expanding R&D headcount.
General and administrative expenses were
€122.7 million for the three months ended June 30, 2023,
compared to €130.0 million for the comparative prior year period.
For the six months ended June 30, 2023, general and
administrative expenses were €242.1 million, compared to
€220.8 million for the comparative prior year period. G&A
expenses were mainly influenced by increased expenses for IT
services as well as expanding the G&A headcount.
Income taxes were realized with an amount
of €221.8 million tax income for the three months ended
June 30, 2023, compared to €647.3 million of tax expenses
accrued for the comparative prior year period. For the six months
ended June 30, 2023, income taxes were realized with an amount
of €16.3 million tax income, compared to €1,966.6 million tax
expenses accrued for the comparative prior year period. The derived
annual effective income tax rate for the six months ended
June 30, 2023, was minus 5.5% which is expected to change over
the 2023 financial year to be in line with the updated estimated
annual cash effective income tax rate of somewhere around 21% for
the BioNTech Group.
Net loss was €190.4 million for the three
months ended June 30, 2023, compared to €1,672.0 million
net profit for the comparative prior year period. For the six
months ended June 30, 2023, net profit was €311.8
million, compared to €5,370.8 million net profit for the
comparative prior year period.
Cash and cash equivalents as well as security
investments were €14,166.6 million as well as
€2,667.0 million, respectively, as of June 30, 2023.
Subsequent to the end of the reporting period, the payment settling
BioNTech’s gross profit share for the first quarter of 2023 (as
defined by the contract with Pfizer) in the amount of
€1,059.2 million was received from BioNTech's collaboration
partner as of July 17, 2023. In addition, until early August
2023, €437.7 million was received in connection with the
amended COVID-19 Vaccine Purchase Agreement with the European
Commission (EC).
Loss per share was €0.79 for the three
months ended June 30, 2023, compared to a diluted earnings per
share €6.45 for the comparative prior year period. For the six
months ended June 30, 2023, diluted earnings per share
was €1.28, compared to €20.69 diluted earnings per share for the
comparative prior year period.
Shares outstanding as of June 30, 2023,
were 239,771,156, excluding 8,781,044 shares in treasury.In March
2023, BioNTech initiated a new share repurchase program pursuant to
which the Company may purchase American Depositary Shares, or ADSs,
each representing one ordinary share of the Company, in the amount
of up to $0.5 billion during the remainder of 2023. During the
three months ended June 30, 2023, 1,532,685 American Depositary
Shares were repurchased under the share repurchase program of ADSs
at an average price of €100.45 ($108.923), for total consideration
of €154.0 million ($166.9 million3).
Cash outflows and share consideration in
connection with the acquisition of InstaDeep Ltd. (“InstaDeep”) on
July 31, BioNTech invested approximately €450 million not including
potential future milestones.
“We enter the second half of 2023 with a strong
financial position, on track to launch our new variant-adapted
COVID-19 vaccine and to conduct multiple clinical trials with
registrational potential across our oncology and infectious disease
pipeline. The COVID-19 vaccine market remains highly dynamic and
difficult to fully predict. Along with our partner Pfizer, the
Company continues to focus on supporting successful vaccinations
during the autumn respiratory infection season,” said Jens
Holstein, CFO of BioNTech. ”It is our goal to become a
multi-product company by investing in our own clinical programs and
by complementing them with additional compounds from our partners.
With some uncertainty on the revenue line, we are also carefully
watching our spending by revisiting our cost base while remaining
focused on executing against our strategic goals and providing
value to the public and our shareholders.”
Outlook for the 2023 Financial YearThe
Company reiterates its COVID-19 vaccine revenue guidance and
updates its previous expense and capex guidance for the 2023
financial year:
BioNTech COVID-19 Vaccine Revenues for the 2023
Financial Year:
Estimated BioNTech COVID-19 vaccine revenues for the full 2023
financial year |
~ €5 billion |
This estimate reflects expected revenues related
to BioNTech’s share of gross profit from COVID-19 vaccine sales in
the collaboration partners’ territories, from direct COVID-19
vaccine sales to customers in BioNTech’s territory and expected
revenues generated from products manufactured by BioNTech and sold
to collaboration partners, which may be influenced by costs such as
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 some geographies and an expected
regulatory recommendation to adapt the COVID-19 vaccines to address
newly circulating variants or sublineages of SARS-CoV-2. While
vaccine adaptation is expected to lead to increased demand, fewer
primary vaccinations and lowered population-wide levels of boosting
are anticipated. In addition, seasonal demand is assumed, moving
expected revenue generation to the second half of the year 2023 as
previously reported. The revenues guidance reflects the revenues as
specified by the amendment of the contractual agreement with the EC
on behalf of the member states while it largely remains dependent
on revenues generated in BioNTech’s collaboration partner’s
territories. The market dynamics for COVID-19 vaccines are
influenced by various factors which underlie substantial
uncertainties and might affect the demand for COVID-19 vaccines in
general as well as the Company’s estimated revenues.
Planned 2023 Financial Year Expenses and
Capex4:
|
Previous Guidance |
Updated Guidance |
R&D expenses5 |
€2,400m - €2,600m |
€2,000m - €2,200m |
SG&A expenses |
€650m - €700m |
€600m - €700m |
Capital expenditures for operating activities6 |
€500m - €600m |
€350m - €450m |
Estimated 2023 Financial Year Tax
Assumptions:
|
Previous Guidance |
Updated Guidance |
BioNTech Group estimated annual cash effective income tax
rate7 |
~ 27% |
~ 21% |
The full interim unaudited condensed
consolidated financial statements can be found in BioNTech’s Report
on Form 6-K, filed today with the United States Securities and
Exchange Commission (“SEC”) and available at
https://www.sec.gov/.
Endnotes1 Financial information is
prepared and presented in Euros and numbers are rounded to millions
and billions of Euros in accordance with standard commercial
practice.2 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.3 Calculated applying the average foreign exchange
rate for the three and six months ended June 30, 2023, as
published by the German Central Bank (Deutsche Bundesbank).4
Numbers reflect current base case projections and are calculated
based on constant currency rates.5 Numbers include effects
identified from additional collaborations or potential M&A
transactions to the extent disclosed and will be updated as
needed.6 Numbers exclude potential effects caused by or driven from
collaborations or M&A transactions.7 Numbers exclude potential
effects caused by or driven from share-based payment settlements in
the course of 2023.
Operational Review and Pipeline Update for
the Second Quarter 2023 and Key Post Period-End Events
COVID-19 Marketed Products
- In May, BioNTech and Pfizer announced an agreement with the EC
to amend the previous COVID-19 Vaccine Purchase Agreement to
deliver COVID-19 vaccines doses to the European Union. The amended
agreement reflects BioNTech and Pfizer’s commitment to working
collaboratively to help address ongoing public health needs, while
respecting the principles of the original agreement. It includes
re-phasing of delivery of doses annually through 2026. In addition,
the agreement includes an aggregate volume reduction, providing
additional flexibility for EU Member States. The EC will maintain
access to future adapted COVID-19 vaccines and the ability to
donate doses, in alignment with the original agreement.
- In June, BioNTech and Pfizer submitted regulatory applications
to the EMA and to the U.S. FDA for their Omicron XBB.1.5-adapted
monovalent COVID-19 vaccine for individuals 6 months of age and
older in line with recommendations from both regulatory agencies.
Regulatory submissions in other territories have also been
initiated.
- BioNTech and Pfizer have manufactured Omicron XBB.1.5-adapted
monovalent COVID-19 vaccine doses at risk to ensure readiness ahead
of the fall and winter seasons in various regions worldwide. The
companies plan to prepare shipments of Omicron XBB.1.5-adapted
monovalent COVID-19 vaccine doses for fast delivery following
potential regulatory approval.
Oncology Pipeline Highlights - Recent and
upcoming trial starts and data readouts
BNT316/ONC-392 (gotistobart) is a
next-generation anti-CTLA-4 monoclonal antibody candidate jointly
developed by BioNTech and OncoC4, Inc. (“OncoC4”). BNT316/ONC-392
offers a potentially differentiated safety profile that may allow
for higher dosing and longer duration of treatment both as a
monotherapy and in combination with other therapies.
- In June, BioNTech and OncoC4 initiated a Phase 3 clinical trial
(NCT05671510) to evaluate BNT316/ONC-392 as monotherapy in
non-small cell lung cancer (NSCLC) patients whose disease
progressed on anti-PD-1/PD-L1 antibody-based therapy. The program
received Fast Track Designation from the FDA in 2022.
- Data from a dose escalation and an expansion cohort evaluating
BNT316/ONC-392 as monotherapy in NSCLC patients that had progressed
on prior immune-checkpoint inhibitor (ICI) therapy as part of the
ongoing Phase 1/2 clinical trial (NCT04140526) were presented at
the American Society of Clinical Oncology (ASCO) Annual Meeting in
June 2023. BNT316/ONC-392 was generally well-tolerated with a
manageable safety profile. Early readout of the expansion cohort
showed encouraging clinical activity in patients with ICI-resistant
NSCLC.
BNT323/DB-1303 is a HER2-targeted
antibody-drug conjugate (ADC) candidate, being developed in
collaboration with Duality Biologics (Suzhou) Co. Ltd.
(“DualityBio”).
- BNT323/DB-1303 is being evaluated in a Phase 1/2 clinical trial
(NCT05150691) in patients with advanced/unresectable, recurrent, or
metastatic HER2-expressing solid tumors. Data from the ongoing
trial were presented at the 2023 ASCO Annual Meeting suggesting
that BNT323/DB-1303 was well tolerated and adverse events (AEs)
were manageable. Preliminary antitumor activity was observed in
heavily pretreated HER2-expressing patients with a median of seven
prior systemic treatment regimens, including other HER2 ADCs.
BNT324/DB-1311 is a topoisomerase-1
inhibitor-based ADC candidate being developed in collaboration with
DualityBio.
- A first-in-human, open-label Phase 1/2 clinical trial
evaluating BNT324/DB-1311 in multiple advanced solid tumors is
planned to start this year.
BNT116 is based on BioNTech’s FixVac
platform, a wholly owned, systemically administered, off-the-shelf
mRNA-based cancer vaccine candidate. This candidate is being
evaluated for the treatment of advanced NSCLC.
- In July 2023, BioNTech and Regeneron Pharmaceuticals Inc.
(“Regeneron”) initiated a randomized, controlled, Phase 2 clinical
trial (NCT05557591) to evaluate BNT116 in combination with
cemiplimab (Regeneron’s Libtayo) and cemiplimab alone as first-line
treatment of patients with advanced NSCLC whose tumors express
PD-L1 in ≥ 50% of tumor cells.
BNT122 (Autogene cevumeran) is an mRNA
cancer vaccine candidate based on an individualized
neoantigen-specific immunotherapy (iNeST) approach being developed
in collaboration with Genentech, a member of the Roche Group
(”Roche”).
- A randomized Phase 2 clinical trial (NCT05968326) is planned to
start in 2H 2023 to further evaluate the safety and efficacy of
BNT122 in the adjuvant setting in combination with atezolizumab
(Genentech’s Tecentriq) followed by chemotherapy in patients with
resected pancreatic ductal adenocarcinoma (PDAC) supported by data
from an investigator-initiated Phase 1 trial (NCT04161755). In May
2023, results from the Phase 1 trial were published in the
peer-reviewed journal Nature. Trials in other indications are
ongoing.
BNT211 is an autologous Claudin-6
(CLDN6)-targeting chimeric antigen receptor (CAR) T cell therapy
candidate that is being tested alone and in combination with an
investigational CAR-T cell Amplifying RNA Vaccine compound, or
CARVac, encoding CLDN6.
- A data update from the ongoing Phase 1/2 clinical trial
(NCT04503278) was provided at the 2023 ASCO Annual Meeting
detailing the new dose escalation of CLDN6 CAR-T cells with and
without a CLDN6-encoding mRNA vaccine for the treatment of
CLDN6-positive relapsed/refractory solid tumors using an automated
manufacturing process. CLDN6 CAR-T cells ± CLDN6 CARVac showed a
moderate safety profile in line with that of manually produced
CLDN6 CAR-T cells. Encouraging signs of clinical activity for dose
level 1 and 2 were confirmed, including dose-dependent expansion of
CAR-T cells demonstrated by an objective response rate (ORR) of 41%
in all 17 evaluable patients and an ORR of 75% in patients at dose
level 2. Follow-up of treated patients and further enrollment of
patients into dose level 2 and 3 are ongoing. After determination
of a recommended Phase 2 dose for CLDN6 CAR-T cells, a pivotal
trial in germ cell tumors is planned to start in 2024.
Corporate Update for the Second Quarter 2023
and Key Post Period-End Events
- In April, BioNTech entered into exclusive license and
collaboration agreements with DualityBio to develop, manufacture
and commercialize two investigational topoisomerase-1
inhibitor-based ADC assets, BNT323/DB-1303 and BNT324/DB-1311. In
August 2023, BioNTech signed another agreement with DualityBio to
develop, manufacture and commercialize an additional antibody-drug
conjugate, DB-1305.
- In July, following on a memorandum of understanding announced
in January, BioNTech signed a long-term strategic partnership
agreement with the UK Government, NHS England and Genomics England
Limited with the aim to provide access to personalized treatments
for up to 10,000 patients by 2030, either in clinical trials or as
authorized treatment. To execute this, BioNTech plans to set up new
laboratories in Cambridge with an expected capacity of more than 70
highly skilled scientists as well as a new regional hub for the
United Kingdom.
- In July, BioNTech also successfully completed its previously
announced acquisition of InstaDeep, following the satisfaction of
all customary closing conditions. The acquisition supports the
Company’s strategy to build world-leading capabilities in
Artificial Intelligence (“AI”)-driven drug discovery and
development. InstaDeep will operate as a UK-based global subsidiary
of BioNTech. The transaction adds approximately 290 highly skilled
professionals to BioNTech’s workforce, including teams in AI,
machine learning (“ML”), bioengineering, data science, and software
development.
Environmental, Social, and Governance
(ESG)
BioNTech was founded out of a responsibility to
patients and to society and this is still the vision that drives
the Company. It gives grounds for BioNTech’s enhanced
responsibility: for translating the Company’s science into the
health of people worldwide and democratizing access to innovative
medicines, for environmental and climate protection, for respecting
human rights and for fostering the full potential of all
employees.
In March 2023, BioNTech published its third ESG
report (Sustainability Report 2022). The report highlights the
Company’s progress in developing novel medicines and introducing
scalable technological innovations. It describes BioNTech’s
science-based climate goals (under SBTi review), actions and
climate risk management as well as the status of the Companies’
human rights strategy and due diligence. The report addresses
diversity, inclusion, equity and belonging, and highlights the
importance of BioNTech’s values and culture.
BioNTech recognizes its responsibility as a
corporate citizen and is committed to supporting its local
communities and beyond through donations, sponsorships and
volunteer activities.
Upcoming Investor and Analyst Events
- BioNTech's third quarter 2023 financial results and corporate
update are scheduled for Monday, November 6, 2023.
- BioNTech will host its 2nd Innovation Day on Tuesday, November
7, 2023, in Boston, USA.
Conference Call and Webcast
Information
BioNTech invites investors and the general
public to join a conference call and webcast with investment
analysts today, August 7, 2023, at 8.00 a.m. EDT (2.00 p.m. CEST)
to report its financial results and provide a corporate update for
the second quarter of 2023.
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
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 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; 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; our expectations with respect to our
intellectual property; the impact of the Company’s
acquisition of InstaDeep Ltd. and collaboration and licensing
agreements with OncoC4, Inc., Duality Biologics (Suzhou) Co. Ltd.
and others; the development of sustainable vaccine production and
supply solutions, 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, 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; 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 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
Interim Consolidated Statements of Profit or
Loss
|
Three months ended June 30, |
Six months ended June 30, |
|
2023 |
2022 |
2023 |
2022 |
(in millions €, except per share
data) |
(unaudited) |
(unaudited) |
(unaudited) |
(unaudited) |
Revenues |
|
|
|
|
Commercial revenues |
166.4 |
3,166.3 |
1,442.9 |
9,528.5 |
Research & development revenues |
1.3 |
30.2 |
1.8 |
42.6 |
Total
revenues |
167.7 |
3,196.5 |
1,444.7 |
9,571.1 |
|
|
|
|
|
Cost of sales |
(162.9) |
(764.6) |
(258.9) |
(2,058.7) |
Research and development expenses |
(373.4) |
(399.6) |
(707.4) |
(685.4) |
Sales and marketing expenses |
(18.1) |
(17.8) |
(30.3) |
(32.1) |
General and administrative expenses |
(122.7) |
(130.0) |
(242.1) |
(220.8) |
Other operating expenses |
(74.2) |
(240.7) |
(192.3) |
(309.5) |
Other operating income |
20.3 |
565.8 |
77.4 |
697.7 |
Operating income / (loss) |
(563.3) |
2,209.6 |
91.1 |
6,962.3 |
|
|
|
|
|
Finance income |
152.4 |
115.5 |
208.9 |
387.6 |
Finance expenses |
(1.3) |
(5.8) |
(4.5) |
(12.5) |
Profit / (loss) before tax |
(412.2) |
2,319.3 |
295.5 |
7,337.4 |
|
|
|
|
|
Income
taxes |
221.8 |
(647.3) |
16.3 |
(1,966.6) |
Profit / (Loss) for the period |
(190.4) |
1,672.0 |
311.8 |
5,370.8 |
|
|
|
|
|
Earnings per share |
|
|
|
|
Basic profit / (loss) for the period per
share |
(0.79) |
6.86 |
1.29 |
22.00 |
Diluted
profit / (loss) for the period per share |
(0.79) |
6.45 |
1.28 |
20.69 |
Interim Consolidated Statements of Financial
Position
|
|
June 30, |
December 31, |
(in millions
€) |
|
2023 |
2022 |
Assets |
|
(unaudited) |
|
Non-current assets |
|
|
|
Intangible assets |
|
501.4 |
219.7 |
Property, plant and equipment |
|
691.1 |
609.2 |
Right-of-use assets |
|
202.9 |
211.9 |
Other financial assets |
|
1,374.3 |
80.2 |
Other non-financial assets |
|
2.5 |
6.5 |
Deferred
tax assets |
|
239.5 |
229.6 |
Total
non-current assets |
|
3,011.7 |
1,357.1 |
Current assets |
|
|
|
Inventories |
|
448.9 |
439.6 |
Trade and other receivables |
|
2,657.9 |
7,145.6 |
Contract assets |
|
5.9 |
— |
Other financial assets |
|
1,390.7 |
189.4 |
Other non-financial assets |
|
212.3 |
271.9 |
Income tax assets |
|
331.6 |
0.4 |
Cash and cash equivalents |
|
14,166.6 |
13,875.1 |
Total current assets |
|
19,213.9 |
21,922.0 |
Total
assets |
|
22,225.6 |
23,279.1 |
|
|
|
|
Equity
and liabilities |
|
|
|
Equity |
|
|
|
Share capital |
|
248.6 |
248.6 |
Capital reserve |
|
1,424.4 |
1,828.2 |
Treasury shares |
|
(8.8) |
(5.3) |
Retained earnings |
|
19,144.8 |
18,833.0 |
Other reserves |
|
(902.5) |
(848.9) |
Total equity |
|
19,906.5 |
20,055.6 |
Non-current liabilities |
|
|
|
Lease liabilities, loans and
borrowings |
|
167.1 |
176.2 |
Other financial liabilities |
|
6.1 |
6.1 |
Income tax liabilities |
|
— |
10.4 |
Provisions |
|
8.6 |
8.6 |
Contract liabilities |
|
302.1 |
48.4 |
Other non-financial liabilities |
|
11.7 |
17.0 |
Deferred
tax liabilities |
|
4.5 |
6.2 |
Total
non-current liabilities |
|
500.1 |
272.9 |
Current liabilities |
|
|
|
Lease liabilities, loans and
borrowings |
|
38.6 |
36.0 |
Trade payables and other payables |
|
228.6 |
204.1 |
Other financial liabilities |
|
172.5 |
785.1 |
Refund liabilities |
|
— |
24.4 |
Income tax liabilities |
|
554.9 |
595.9 |
Provisions |
|
374.8 |
367.2 |
Contract liabilities |
|
201.2 |
77.1 |
Other
non-financial liabilities |
|
248.4 |
860.8 |
Total
current liabilities |
|
1,819.0 |
2,950.6 |
Total
liabilities |
|
2,319.1 |
3,223.5 |
Total
equity and liabilities |
|
22,225.6 |
23,279.1 |
Interim Consolidated Statements of Cash
Flows
|
|
Three months ended June 30, |
Six months ended June 30, |
|
|
2023 |
2022 |
2023 |
2022 |
(in
millions €) |
|
(unaudited) |
(unaudited) |
(unaudited) |
(unaudited) |
Operating activities |
|
|
|
|
|
Profit / (Loss) for the period |
|
(190.4) |
1,672.0 |
311.8 |
5,370.8 |
Income
taxes |
|
(221.8) |
647.3 |
(16.3) |
1,966.6 |
Profit
/ (Loss) before tax |
|
(412.2) |
2,319.3 |
295.5 |
7,337.4 |
Adjustments to reconcile profit before tax
to net cash flows: |
|
|
|
|
|
Depreciation and amortization of property, plant, equipment,
intangible assets and right-of-use assets |
|
31.9 |
33.2 |
63.3 |
60.8 |
Share-based payment expenses |
|
13.1 |
14.8 |
21.7 |
25.0 |
Net foreign exchange differences |
|
(397.0) |
(344.6) |
(343.9) |
(338.5) |
Loss on disposal of property, plant and equipment |
|
0.1 |
0.2 |
0.3 |
0.2 |
Finance income excluding foreign exchange differences |
|
(126.6) |
(1.5) |
(208.9) |
(218.8) |
Finance expense excluding foreign exchange differences |
|
1.3 |
5.8 |
2.5 |
12.5 |
Movements in government grants |
|
— |
— |
(3.0) |
— |
Net loss on derivative instruments at fair value through profit or
loss |
|
12.0 |
86.5 |
88.2 |
84.6 |
Working capital adjustments: |
|
|
|
|
|
Decrease in trade and other receivables, contract assets and other
assets |
|
5,123.6 |
3,174.8 |
6,017.4 |
2,771.3 |
Decrease / (increase) in inventories |
|
(24.8) |
91.6 |
(9.3) |
134.8 |
(Decrease) / increase in trade payables, other financial
liabilities, other liabilities, contract liabilities, refund
liabilities and provisions |
|
592.7 |
(663.1) |
(268.9) |
194.4 |
Interest received |
|
42.5 |
1.5 |
96.1 |
2.2 |
Interest paid |
|
(1.3) |
(5.8) |
(2.5) |
(12.2) |
Income tax paid |
|
(437.3) |
(791.4) |
(1,282.2) |
(2,081.4) |
Share-based payments |
|
(31.3) |
(2.2) |
(757.0) |
(3.0) |
Net
cash flows from operating activities |
|
4,386.7 |
3,919.1 |
3,709.3 |
7,969.3 |
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
Purchase of property, plant and
equipment |
|
(67.2) |
(70.6) |
(112.4) |
(114.7) |
Purchase of intangible assets and
right-of-use assets |
|
(242.1) |
(4.8) |
(251.7) |
(21.5) |
Investment in other financial assets |
|
(1,982.5) |
(3.0) |
(2,663.1) |
(30.0) |
Proceeds
from maturity of other financial assets |
|
— |
— |
— |
375.2 |
Net
cash flows from / (used in) investing activities |
|
(2,291.8) |
(78.4) |
(3,027.2) |
209.0 |
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
Proceeds from issuance of share capital
and treasury shares, net of costs |
|
— |
— |
— |
110.5 |
Proceeds from loans and borrowings |
|
— |
0.2 |
— |
0.2 |
Repayment of loans and borrowings |
|
— |
— |
— |
(18.8) |
Payments related to lease liabilities |
|
(9.4) |
(10.5) |
(18.7) |
(21.9) |
Share repurchase program |
|
(154.0) |
(286.9) |
(436.0) |
(286.9) |
Dividends |
|
— |
(484.3) |
— |
(484.3) |
Net
cash flows used in financing activities |
|
(163.4) |
(781.5) |
(454.7) |
(701.2) |
|
|
|
|
|
|
Net increase in cash and cash
equivalents |
|
1,931.5 |
3,059.2 |
227.4 |
7,477.1 |
Change in cash and cash equivalents
resulting from exchange rate differences |
|
91.2 |
111.5 |
64.1 |
165.0 |
Cash and
cash equivalents at the beginning of the period |
|
12,143.9 |
6,164.1 |
13,875.1 |
1,692.7 |
Cash
and cash equivalents as of June 30 |
|
14,166.6 |
9,334.8 |
14,166.6 |
9,334.8 |
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