-
Second quarter revenues of €3.2 billion1, net profit of
€1.7 billion and fully diluted earnings per share of €6.45
($6.872) as well as first half 2022 revenues of €9.6 billion,
net profit of €5.4 billion and fully diluted earnings per
share of €20.69 ($18.922)
- Reiterates BioNTech COVID-19 2022 vaccine revenue guidance of
€13 billion to €17 billion
- Preparing for potential launch of two variant-adapted bivalent
COVID-19 vaccines containing the original strain and Omicron BA.1
or BA.4/5 spike protein as recommended by U.S. Food and Drug
Administration (FDA), European Medicines Agency (EMA) and other
regulators; expect to be able to begin delivering Omicron-adapted
vaccines as early as October 2022, subject to regulatory
approval
- Signed agreement with U.S. government to provide additional 105
million doses of COVID-19 vaccine with option for another 195
million doses
- Received U.S. Emergency Use Authorization (EUA) for COVID-19
vaccine in children six months through four years of age and for a
booster dose in children five through 11 years of age
- Continued pipeline expansion with initiation of two new Phase 1
clinical trials (BNT116 and BNT142) to 18 clinical-stage oncology
programs in 23 ongoing clinical trials; BNT211, first-in-class
CAR-T program targeting CLDN6, receives EMA Priority Medicines
(PRIME) designation
- Commenced construction of first BioNTainer mRNA vaccine
manufacturing facility in Africa
Conference call and webcast scheduled for August
8, 2022, at 8:00 am ET (2:00 pm CET)
MAINZ, Germany, August 8, 2022
(GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX,
“BioNTech” or the "Company”) today reported financial results for
the three and six months ended June 30, 2022 and provided an update
on its corporate progress.
“In the first half of 2022, we achieved
important milestones as we have further strengthened our COVID-19
vaccine leadership and have expanded our broad pipeline and
accelerated its maturation. Our COVID-19 product pipeline includes
variant-adapted and next-generation vaccine candidates, aimed at
prolonged and broad protection,” said Prof. Ugur Sahin,
M.D., CEO and Co-Founder of BioNTech. “In oncology, we
have presented encouraging data updates for our individualized mRNA
cancer vaccine candidate BNT122 in pancreatic cancer and our novel
CAR-T cell therapy candidate BNT211 in solid tumors, leading to our
first PRIME designation by EMA. We drive toward the preparation of
registrational trials as well as the delivery of our first
BioNTainers to Africa, aiming to provide access to novel
medicines.”
Key Second Quarter Financial Results
in millions, except per share data |
Second Quarter 2022 |
Second Quarter 2021 |
First Half 2022 |
First Half 2021 |
Total Revenues1 |
€3,196.5 |
€5,308.5 |
€9,571.1 |
€7,356.9 |
Net Profit |
€1,672.0 |
€2,787.2 |
€5,370.8 |
€3,915.3 |
Diluted Earnings per Share |
€6.45 |
€10.77 |
€20.69 |
€15.14 |
“With our strong performance year to date, we
believe to be well on track to achieve our previous financial
guidance for the ongoing financial year,” said Jens
Holstein, CFO of BioNTech. “With our initiatives around
variant-adapted COVID-19 vaccine candidates, we expect an uptake in
demand in our key markets in the fourth quarter of 2022, subject to
regulatory approval. We will continue to invest heavily in research
and development in 2022 and beyond and remain focused on furthering
our oncology pipeline as well as driving our leadership in COVID-19
vaccine development. We are driving toward potential launches of
multiple innovative products to address diseases with high unmet
medical need in the coming three to five years.”
Outlook for the 2022 Financial Year
Reiterated
The Company reiterates its prior 2022 financial
year outlook, which includes the following components:
BioNTech COVID-19 Vaccine Revenues for the 2022
Financial Year:
Estimated BioNTech COVID-19 vaccine revenues for the full 2022
financial year |
€13 billion - €17 billion |
This revenue 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.
Planned 2022 Financial Year Expenses and
Capex:
R&D expenses |
€1,400 million - €1,500 million |
SG&A expenses |
€450 million - €550 million |
Capital expenditures |
€450 million - €550 million |
The ranges reflect current base case projections
and do not include potential effects caused by or driven from
additional collaborations or potential merger and acquisition
transactions.
Estimated 2022 Financial Year Tax
Assumptions:
BioNTech Group estimated annual effective income tax rate |
~28% |
Detailed Second Quarter Financial
Results
- Revenues: Total revenues reported were €3,196.5 million1
for the three months ended June 30, 2022, compared to
€5,308.5 million1 for the comparative prior year period. For
the six months ended June 30, 2022, total revenues were
€9,571.1 million1, compared to €7,356.9 million1 for the
comparative prior year period. BioNTech believes the development of
the pandemic remains dynamic, causing a re-phasing of orders and
with this leading to fluctuations in quarterly revenues. This
revenue fluctuation caused by the re-phasing of orders is expected
to remain over the rest of the financial year with an uptake in
demand in key markets in the fourth quarter of 2022 related to the
Omicron-adapted bivalent vaccine, subject to regulatory
approval. Under the collaboration agreements, territories have
been allocated between BioNTech, Pfizer Inc. (“Pfizer”) and
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”)
based on marketing and distribution rights. During the three months
ended June 30, 2022, BioNTech’s commercial revenues included
€1,987.4 million1 gross profit share (€3,923.7 million1
gross profit share and €168.6 million1 sales milestones during
the comparative prior year period). For the six months ended
June 30, 2022, BioNTech's commercial revenues included
€6,574.2 million1 gross profit share (€5,428.4 million1
gross profit share and €415.8 million1 sales milestones during
the comparative prior year period). BioNTech’s share of the
collaboration partners’ gross profit is based on COVID-19 vaccine
sales in Pfizer’s and Fosun Pharma’s territories and represents a
net figure. In addition, during the three and six months ended
June 30, 2022, BioNTech recognized €557.0 million and
€1,720.1 million of direct COVID-19 vaccine sales to customers
in BioNTech’s territory, Germany and Turkey, as well as
€608.3 million and €1,211.5 million from sales of
products manufactured by BioNTech for its collaboration partners.
During the comparative prior year periods, €1,035.6 million
and €1,235.4 million were recognized from sales to customers
in BioNTech’s territory as well as €138.1 million and
€202.0 million from sales of products manufactured by BioNTech
for its collaboration partners, respectively.
- Cost of Sales: Cost of sales were €764.6 million for
the three months ended June 30, 2022, compared to
€883.8 million for the comparative prior year period. For the
six months ended June 30, 2022, cost of sales were
€2,058.7 million, compared to €1,116.9 million for the
comparative prior year period. The change in cost of sales resulted
mainly from the recognition of costs related to BioNTech's COVID-19
vaccine revenues which included the share of gross profit owed to
its collaboration partner Pfizer. In addition, cost of sales was
impacted by expenses arising from inventory write-offs and expenses
for production capacities derived from contracts with contract
manufacturing organizations.
- Research and Development Expenses: Research and development
expenses were €399.6 million for the three months ended
June 30, 2022, compared to €201.1 million for the
comparative prior year period. For the six months ended
June 30, 2022, research and development expenses were
€685.4 million, compared to €417.3 million for the
comparative prior year period. The increase was mainly due to
recognizing costs related to the manufacturing of pre-launch
Omicron vaccine candidates as research and development expenses in
the period incurred and an increase in headcount.
- General and Administrative Expenses: General and administrative
expenses were €130.0 million for the three months ended
June 30, 2022, compared to €47.8 million for the
comparative prior year period. For the six months ended
June 30, 2022, general and administrative expenses were
€220.8 million, compared to €86.7 million for the
comparative prior year period. The increase was mainly due to
recognizing increased expenses for purchased external services as
well as an increase in headcount.
- Income Taxes: Income taxes were accrued with an amount of
€647.3 million for the three months ended June 30, 2022,
compared to €1,235.6 million for the comparative prior year
period. For the six months ended June 30, 2022, income taxes
were accrued in an amount of €1,966.6 million, compared to
€1,749.8 million for the comparative prior year period. The
derived effective income tax rate for the six months ended
June 30, 2022 was 26.8%.
- Net Profit: Net profit was €1,672.0 million for the three
months ended June 30, 2022, compared to €2,787.2 million
for the comparative prior year period. For the six months ended
June 30, 2022, net profit was €5,370.8 million, compared
to €3,915.3 million for the comparative prior year
period.
- Cash, Cash Deposits and Trade Receivables: As of June 30, 2022,
cash and cash equivalents were €9,334.8 million. In addition,
trade receivables remained outstanding as of June 30, 2022, mainly
due to the contractual settlement of the gross profit share under
the COVID-19 collaboration with Pfizer, which 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. Trade
receivables for example include the gross profit share for the
first quarter of 2022 (as defined by the contract) for which the
settlement payment was received subsequent to the end of the
reporting period in July 2022. Of the total trade receivables of
€10,382.9 million which were outstanding as of June 30, 2022,
€5,581.1 million were received in cash as of July 15,
2022. The total cash and cash equivalents amounted to
€14,884.5 million as of July 15, 2022.
- Shares Outstanding: Shares outstanding as of June 30, 2022,
were 242,685,401.
The full interim unaudited condensed
consolidated financial statements can be found in BioNTech’s Report
on Form 6-K, filed today with the SEC and available at
https://www.sec.gov/.
1BioNTech's profit share is estimated based on
preliminary data shared between Pfizer and BioNTech as further
described in BioNTech's Annual Report on Form 20-F for the year
ended December 31, 2021 as well as its Quarterly Report as of and
for the three and six months ended June 30, 2022, filed as an
exhibit to BioNTech’s Current Report on Form 6-K filed on August 8,
2022. Any changes in the estimated share of the collaboration
partner's gross profit will be recognized prospectively.2Calculated
applying the average foreign exchange rates for the three and six
months ended June 30, 2022, respectively as published by the
German Central Bank (Deutsche Bundesbank).
Second Quarter 2022 and
Subsequent Program Updates
COVID-19 Vaccine Program –
BNT162
BioNTech and Pfizer continue to build on their
global COVID-19 vaccine leadership with further label expansions as
well as development of a diverse pipeline of follow-on and next
generation vaccine candidates. Subject to regulatory approval,
Omicron-adapted vaccine launches and clinical trial starts,
including trials for next generation vaccines, are expected to
begin in the second half of 2022.
Commercial updates
As of the beginning of July 2022, BioNTech and
Pfizer have delivered in total more than 3.6 billion doses to 180
countries or territories. The companies have signed orders for
approximately 2.5 billion doses for 2022, and, in the first half of
the year, invoiced approximately 1.2 billion doses. The cumulative
share of doses3 increased in the period between January 1, 2022 to
July 20, 2022 from approximately 52% to 63% in all markets4,5. In
developed markets6, the share of doses for the same time period
increased from approximately 59% to 68%. As part of BioNTech and
Pfizer's 2-billion-doses-pledge to support equitable access to
medicines, the companies have delivered more than 1.5 billion doses
of the companies’ COVID-19 vaccine in total to low- and
middle-income countries.
- In May 2022, BioNTech and Pfizer announced an agreement with
the European Commission, or EC, to amend their originally agreed
contractual delivery schedules for the COVID-19 vaccine. The
amendment rephases planned deliveries to help support the EC and
Member States' ongoing immunization programs and is aligned to the
companies’ commitment to working collaboratively to identify
pragmatic solutions to address the evolving pandemic needs. Doses
scheduled for delivery in June through August 2022 will now be
delivered in September through to the fourth quarter of 2022. This
change of delivery schedule did not impact the companies’ full-year
2022 revenue guidance or the full-year commitment of doses to be
delivered to EC Member States in 2022.
- In June 2022, BioNTech and Pfizer entered into a new vaccine
supply agreement with the U.S. government. Under the terms of the
agreement, the U.S. government will receive 105 million doses,
including 30 µg, 10 µg and 3 µg doses, potentially including the
Omicron-adapted adult vaccine, subject to granting of U.S. FDA
Emergency Use Authorization, or EUA. The U.S. government also has
the option to purchase up to an additional 195 million doses,
bringing the potential total to 300 million vaccine doses. Delivery
of the vaccine doses is scheduled to begin in late summer 2022 and
will continue into the fourth quarter of this year. The U.S.
government will pay the two companies $3.2 billion after receiving
the first 105 million doses of vaccine.
3 Market share data includes only those markets
in which Pfizer operates and that report market share data4 Incl.
all markets in Developed Markets (5) plus Emerging Markets
(Argentina, Chile, Ecuador, Hong Kong, Nepal, Peru, South Africa,
Uruguay)5 Includes the U.S., EU/EEA, other Int'l Developed markets
(Japan, South Korea, Switzerland, Ukraine)6 Starting date of
January 1, 2022 for this data set is from Q1 2022 earnings
presentation
Manufacturing updates
BioNTech and Pfizer’s global COVID-19 vaccine
supply chain and manufacturing network includes 20 manufacturing
facilities spanning four continents.
- BioNTech and Pfizer have started to manufacture bivalent
Omicron BA.1- and BA.4/5-adapted vaccines. Pending regulatory
approval, the companies expect to deliver the updated vaccines as
soon as October 2022 and plan to supply both vaccines in time for
fall booster campaigns.
Clinical development and regulatory updates
BioNTech and Pfizer’s COVID-19 vaccine has
received multiple regulatory approvals including expansions of
authorizations for booster and pediatric vaccinations.
- In May 2022, the U.S. FDA expanded the EUA to include a booster
dose in children five through 11 years of age. The EUA was granted
based on data from the Phase 2/3 clinical trial demonstrating a
high immune response following a booster dose after completion of
the primary series of BNT162b2 in this age group. Data demonstrated
that a booster dose given approximately six months after the second
dose of the 10 µg primary series increased neutralizing antibodies
by six-fold against the SARS-CoV-2 wild-type strain compared to
levels observed after two doses. The vaccine was well tolerated
with no new safety signals observed. The data were also
submitted to the EMA for a variation of the Conditional Marketing
Authorization (CMA), in the European Union to include a booster
dose in this age group and are being filed with other regulatory
authorities worldwide.
- In June 2022, the U.S. FDA amended the EUA to include children
six months of age through four years of age. The EUA was granted
based on safety, immunogenicity and vaccine efficacy topline data
from a Phase 2/3 study evaluating a third 3 µg dose in 1,678
children in this age group. Following a third dose in this age
group, the vaccine elicited a strong immune response with a
favorable safety profile similar to placebo. The vaccine met all
immunobridging criteria required for an EUA, based on an
immunogenicity analysis conducted on a subset of study participants
one month following the third dose in this age group, compared to
the second dose in the 16- to 25-year-old population. Further data
on this age group will be shared in the coming weeks. The data
were also submitted to the EMA for a line extension of the CMA in
the European Union in this age group and are expected to be filed
with other regulatory authorities in the coming weeks.
- In July 2022, the U.S. FDA also approved the supplemental
Biologics License Application, or sBLA, to include individuals 12
through 15 years of age in the approved indication, expanding
licensure of the vaccine to this age group, which was previously
included under U.S. EUA.
BNT162b2 has demonstrated a high level of
protection against several variants of concern, including Alpha,
Beta, and Delta and continues to offer protection against severe
disease, hospitalization and death for circulating
Omicron-variants. BioNTech and Pfizer continue to monitor
protection offered by BNT162b2 against emerging SARS-CoV-2
variants.
The companies are currently evaluating
variant-adapted COVID-19 vaccines, including monovalent and
bivalent vaccines directed against Omicron subvariants and other
strains of SARS-CoV-2. Data from these studies were presented to
regulatory agencies in June and July 2022, which supported the
regulators’ discussions for the development of Omicron-adapted
vaccines and definition of the most appropriate regulatory
pathways. BioNTech and Pfizer will continue to submit available
data to regulatory authorities worldwide. In June 2022, the U.S.
FDA advised vaccine manufacturers to develop modified vaccines that
add an Omicron BA.4/5 spike protein encoding component to the
current vaccine composition to create a bivalent booster
vaccine.
- In June 2022, BioNTech and Pfizer announced positive safety,
tolerability and immunogenicity data for two Omicron BA.1-adapted
vaccine candidates, including data on a monovalent and a bivalent
vaccine candidate combining the existing vaccine and a vaccine
candidate targeting the Omicron variant BA.1 spike
protein. Results from this Phase 2/3 trial in 1,234 subjects
aged 56 years or older show that booster doses of 30 µg and 60 µg
of both Omicron BA.1-adapted monovalent and bivalent vaccine
candidates elicit significantly higher neutralizing antibody
responses against Omicron BA.1 compared to BNT162b2, consistent
with the regulatory requirements for superiority. The monovalent
Omicron-adapted vaccine 30 µg and 60 µg achieved the regulatory
requirement of super superiority. One month after administration, a
booster dose of the Omicron BA.1-adapted monovalent candidates
increased neutralizing geometric mean titers, or GMTs, against
Omicron BA.1 13.5- and 19.6-fold above pre-booster dose levels.
Booster vaccination with the bivalent Omicron BA.1-adapted vaccine
candidates resulted in a 9.1- and 10.9-fold increase in
neutralizing GMTs against Omicron BA.1, respectively. Both vaccine
candidates demonstrated a favorable safety and tolerability profile
similar to BNT162b2. In preclinical studies in mice, both
monovalent and bivalent Omicron BA.4/5-adapted vaccine candidates
were observed to substantially increase Omicron neutralization
responses against all Omicron sublineages, including BA.1, BA.4/5
and the wild-type strain. Given the FDA guidance, BioNTech and
Pfizer plan to distribute a bivalent vaccine encoding for the spike
protein of the original strain as well as of the BA.4/BA.5 Omicron
sublineage to be used as a booster, subject to regulatory
authorizations. In addition, BioNTech and Pfizer plan to initiate a
clinical trial in August 2022 to generate immunogenicity and safety
data for an Omicron BA.4/5-adapted bivalent vaccine.
- In July 2022, BioNTech and Pfizer completed the submission to
the EMA for an Omicron-adapted bivalent COVID-19 vaccine, based on
the BA.1 sublineage, for individuals 12 years of age and older.
This application follows guidance from the EMA to move forward with
introducing an Omicron-adapted bivalent vaccine candidate to
address the continued evolution of the SARS-CoV-2 virus. The
companies are preparing to initiate the submission of pre-clinical
and Chemistry, Manufacturing and Controls (CMC) data for a bivalent
vaccine candidate encoding Omicron BA.4/5 spike protein to EMA
beginning in August 2022.
- In a recent preprint publication (bioRxiv. Omicron BA.2
breakthrough infection enhances cross-neutralization of BA.2.12.1
and BA.4/BA.5; August 2022) BioNTech reported data demonstrating
that sera from triple mRNA-vaccinated individuals who experienced
Omicron sublineage BA.2 breakthrough infection demonstrated broad
neutralizing activity against variants of concern, including
Omicron BA.2 derived variants BA.2.12.1, BA.4/BA.5. In addition,
the data showed that neutralization of BA.2 and BA.4/BA.5
sublineages by BA.2 convalescent sera is driven to a large extent
by antibodies targeting the N-terminal domain, or NTD, of the spike
glycoprotein. In comparison, neutralization by Omicron BA.1
convalescent sera depends on antibodies targeting the receptor
binding domain. These findings suggest that Omicron BA.2 triggers
significant NTD specific recall responses in vaccinated
individuals, which enhances the neutralization of BA.4/BA.5
sublineages. Given the current epidemiology with a predominance of
BA.2 derived sublineages like BA.4/BA.5 and rapidly ongoing
evolution, these findings will increase current understanding on
Omicron immune escape mechanisms and the effects of immunization on
variant cross-neutralization, and thus will help guide further
vaccine development.
BioNTech and Pfizer are investigating and
identifying novel next-generation vaccine approaches to maintain a
broad and longer lasting immune response and high levels of
protection against SARS-CoV-2 as it evolves. The long-term strategy
takes a multipronged approach devised to develop and test multiple
engineered vaccine candidates to achieve the goal of delivering a
pan-SARS-CoV-2-type vaccine that will ultimately help to better
manage upcoming variants of concern. The companies expect that
scientific data derived from those different approaches will
support the vaccine candidate selected for evaluation in a pivotal
trial.
BioNTech and Pfizer plan to test several novel
vaccine constructs that have been engineered to engage multiple
arms of the immune system, including antibodies and T cells. These
next-generation vaccine approaches the companies plan to evaluate
include an enhanced SARS-CoV-2 spike antigen and a T cell enhancing
vaccine candidate.
- In July 2022, as a first step of BioNTech and Pfizer’s
long-term strategy of developing a next-generation COVID-19
vaccine, a randomized, active-controlled, observer-blind, Phase 2
study was initiated to evaluate the safety, tolerability, and
immunogenicity of a 30 µg dose of an enhanced spike antigen vaccine
candidate. This first of multiple candidates with an engineered
design, BNT162b5, consists of RNAs encoding for a sequence-modified
spike protein of the SARS-CoV-2 ancestral strain and the Omicron
BA.2 variant. The enhanced prefusion spike protein in BNT162b5 has
been modified with the aim to increase the magnitude and breadth of
antibody neutralization response to better protect against
COVID-19.
- Additionally, in the second half of 2022, BioNTech and Pfizer
anticipate progressing T cell enhancing and pan-SARS-CoV-2
vaccine candidates into the clinic.
Additional Infectious Disease
Programs
BioNTech is on track to initiate two
first-in-human clinical trials in the second half of 2022 that
include mRNA-based product candidates designed to address shingles
(in collaboration with Pfizer), and herpes simplex virus type 2
(HSV 2; BNT163).
First-in-human clinical trials for tuberculosis
(BNT164) and malaria (BNT165) are now expected to start in the
second half of 2022 or early 2023.
Influenza Vaccine Program
BNT161 - BioNTech is collaborating with Pfizer
to develop an influenza vaccine based on BioNTech's suite of mRNA
platforms.
- A Phase 1/2 trial to evaluate BNT161, a quadrivalent
nucleoside-modified RNA (modRNA) vaccine candidate, is ongoing and
a dose-finding study for a self-amplifying RNA (saRNA) vaccine
candidate has started.
- In July 2022, data were reported from the Phase 2 expansion
study of BNT161 in subjects 65 years of age and older showing first
evidence of substantial induction of strain specific CD4+ and CD8+
responses. At day seven after vaccination with BNT161, the
geometric mean fold rise, or GMFR, for CD4+ T cells was more than
two-fold for all four encoded strains. For strain specific CD8+ T
cells, the GMFR was more than two-fold for the Victoria B subtype
and influenza B subtype (H3N2). The GMFR was higher compared to the
control quadrivalent influenza vaccine for both CD4+ and CD8+
strain specific T cell responses. Based on these encouraging T cell
responses and observed seroconversion, a Phase 3 study of the
quadrivalent modified mRNA influenza vaccine is planned to initiate
in the second half of 2022.
Oncology
BioNTech’s immuno-oncology strategy is based on
pioneering approaches that harness the immune response to treat
cancer. The Company has multiple clinical stage assets across
different therapeutic classes which may have the potential to
tackle tumors using complementary strategies, either by targeting
tumor cells directly or by modulating the immune response against
the tumor. The Company’s oncology pillars include mRNA therapeutic
vaccines, cell therapies (CAR-, TCR-, and neoantigen-specific T
cell therapies), mRNA-encoded effector molecules (RiboMabs and
RiboCytokines), next-generation immune checkpoint inhibitors and
agonists, anti-tumor antibodies and immune-modulatory small
molecules. Many product candidates have the potential to be
combined with other pipeline assets or already approved
therapies.
BioNTech’s clinical stage oncology pipeline
includes a total of 18 product candidates in 23 ongoing clinical
trials including five in randomized Phase 2 clinical trials: two
FixVac programs (BNT111 and BNT113), two indications for the iNeST
product candidate autogene cevumeran (BNT122/RO7198457), and the
bispecific antibody immune checkpoint modulator BNT311 (GEN1046).
BNT116, a FixVac program for non-small cell lung cancer (NSCLC) and
BNT142, a RiboMab program targeting CD3 on T cells and Claudin-6
(CLDN6) in solid tumors, have recently entered first-in-human
clinical testing.
BioNTech expects continued pipeline advancement
and expansion, as well as further data readouts from the ongoing
trials, for the remainder of 2022.
mRNA programs
FixVac
BioNTech’s off-the-shelf cancer immunotherapy
approach, FixVac, leverages the Company's proprietary uridine mRNA
(uRNA) backbone for full actualization of the intrinsic
adjuvanticity of RNA that encodes cancer-specific shared antigens
for intravenous administration using the proprietary RNA-LPX
formulation and aiming for induction of strong antigen-specific
immune responses. FixVac product candidates may be of clinical
utility in combination with anti-PD1 in patients with lower
mutational burden tumors, including those who have already
experienced checkpoint inhibitor (CPI) therapy.
Two FixVac programs are in ongoing Phase 2
trials: BNT111 in PD1 inhibitor refractory/relapsed melanoma (in
collaboration with Regeneron Pharmaceuticals, Inc., “Regeneron”)
and BNT113 in HPV16+ PDL1+ head and neck cancer.
BNT116 is being evaluated in a Phase 1 clinical
trial. It is designed to elicit an immune response to six
tumor-associated antigens that cover up to 100% of patients in all
major histologic subtypes of non-small cell lung cancer.
- In July 2022, the first participant was dosed in a
first-in-human clinical trial evaluating the safety, tolerability
and preliminary efficacy of BNT116 alone and in combination in
patients with advanced or metastasized NSCLC. The trial will
comprise several cohorts and is intended to establish a safe dose
for BNT116 monotherapy as well as for BNT116 in combination with
cemiplimab (Regeneron's Libtayo®) in patients who have progressed
on prior PD-1 inhibitor treatment or are not eligible for
chemotherapy, and in combination with docetaxel in patients who
have received prior platinum-based chemotherapy.
Individualized neoantigen specific immunotherapy
(iNeST)
BioNTech's individualized cancer immunotherapy
approach (iNeST) is also based on a pharmacologically optimized
uridine mRNA (uRNA) backbone delivered in the Company’s proprietary
RNA-LPX formulation.
BioNTech’s lead iNeST product candidate,
autogene cevumeran (BNT122), is being developed together with
Genentech, Inc. (“Genentech”) as part of a co-development and
co-commercialization collaboration.
Each patient is treated with a vaccine informed
by the mutation profile of their personal cancer and manufactured
on-demand. The RNA encodes a unique composition of the patient’s
own tumor mutations and results in generation of neoantigen
specific CD4+ and CD8+ T cell responses. BioNTech believes this
modality is well-suited for use in early-stage cancers and the
adjuvant setting.
- A randomized Phase 2 trial of autogene cevumeran in the
adjuvant treatment of circulating tumor DNA (ctDNA) positive,
surgically resected Stage II (high-risk)/Stage III colorectal
cancer is ongoing.
- A data update from the ongoing randomized Phase 2 trial of
autogene cevumeran combined with pembrolizumab in patients with
first-line metastatic melanoma is now expected in the first half of
2023.
- In June 2022, initial data from an investigator-initiated Phase
1 clinical trial of autogene cevumeran evaluating safety and
tolerability in combination with the anti-PD-L1 immune checkpoint
inhibitor atezolizumab and chemotherapy in patients with surgically
removed pancreatic ductal adenocarcinoma, or PDAC, was presented at
the 2022 American Society of Clinical Oncology (ASCO) Annual
Meeting. 16 patients had their tumor surgically removed, were
subsequently treated with a single dose of atezolizumab and
received autogene cevumeran. Preliminary data from these 16 treated
patients showed that autogene cevumeran was well tolerated. De novo
neoantigen-specific T cell responses of high magnitude were induced
in 50% (eight out of 16) of patients. After an early median
follow-up of 18 months, patients with this type of immune response
had a significantly longer recurrence-free survival, or RFS, than
those without a high magnitude vaccine-induced immune response.
Based on these data, BioNTech and Genentech are planning a
randomized study to further evaluate the efficacy and safety of
autogene cevumeran in combination with atezolizumab and
chemotherapy in patients with resected PDAC.
RiboMabs
BioNTech’s RiboMab product candidates, BNT141
and BNT142, are based on mRNA and designed to encode cancer cell
targeting antibodies. These product candidates leverage the
Company’s proprietary optimized mRNA technology combining
nucleoside modifications to minimize immunogenicity with
modifications in the mRNA backbone with the aim of maximizing
protein expression. RiboMabs may address the limitations of
recombinant antibodies, including avoidance of protein
manufacturing challenges and short plasma half-life.
BNT141 encodes an antibody targeting
Claudin-18.2, expressed in high unmet medical need tumors,
including multiple epithelial solid tumors, such as gastric,
biliary and pancreatic cancers.
BNT142 encodes a bispecific T cell engaging
antibody that targets CD3, a T cell receptor component, and CLDN6,
an oncofetal cell surface antigen found in solid tumors such as
testicular and ovarian cancers.
- BNT142 – In July 2022, the first participant was dosed in an
open-label, multi-center, Phase 1/2 dose escalation, safety, and
pharmacokinetic trial of BNT142 followed by expansion cohorts in
patients with CLDN6-positive advanced solid tumors. The trial is
evaluating BNT142 as monotherapy in patients that have exhausted
therapy or are not eligible for standard of care therapy. After
dose escalation, BNT142 will be evaluated in expansion cohorts in
testicular cancer, ovarian cancer, and non-squamous NSCLC.
Cell therapies
CAR-T cell immunotherapy
BNT211, BioNTech’s first chimeric antigen
receptor, or CAR-T cell product candidate, targets CLDN6-positive
solid tumors in combination with a CAR-T cell-amplifying RNA
vaccine, or CARVac, encoding CLDN6. CARVac is also based on a
pharmacologically optimized uridine mRNA (uRNA) backbone delivered
in the Company’s proprietary RNA-LPX formulation. CLDN-6 CAR-T
cells are equipped with a second-generation CAR of high sensitivity
and specificity for the tumor-specific carcino-embryonic antigen
CLDN6. CARVac drives in vivo expansion of transferred CAR-T cells,
aiming to increase their persistence and efficacy. BNT211 is
designed to overcome CAR-T cell therapy limitations in patients
with solid tumors.
- BNT211 – A Phase 1/2 open-label dose escalation and dose
expansion trial evaluating BNT211 in patients with CLDN6-positive
solid tumors is ongoing. Data from the ongoing trial were
presented at the American Association for Cancer Research (AACR)
Conference in April 2022 and at the annual meeting of the
Association for Cancer Immunotherapy (CIMT) in May 2022. The
preliminary efficacy data showed encouraging signs of clinical
activity with a disease control rate of 86% and an overall response
rate of 43%. The results also demonstrated an encouraging safety
profile as adverse events and dose limiting toxicities were
manageable. Another data update from the ongoing Phase 1/2 trial is
expected in the second half of 2022.
- In June 2022, the EMA granted Priority Medicines (PRIME)
designation to BNT211 for the third- or later-line treatment of
testicular germ cell tumors. The PRIME status is granted to drug
candidates that may offer a major therapeutic advantage over
existing treatments and provides early and proactive EMA support to
developers of medicines that target an unmet medical need. BNT211
will benefit from this interaction with the EMA through the next
development phase.
Antibodies
Next generation immunomodulators
In August 2022, BioNTech announced the expansion
of its global strategic collaboration with Genmab A/S (“Genmab”)
for the joint development of BNT313 (GEN1053), a CD27 antibody,
applying Genmab's proprietary HexaBody® technology. Under this
50/50 collaboration, the development costs and potential future
profits for BNT313 will be shared equally.
- BNT313 (GEN1053) – A Phase 1 trial to evaluate the safety,
tolerability, and preliminary efficacy of BNT313 on malignant solid
tumors as monotherapy is expected to be initiated in the second
half of 2022. The trial will consist of two parts. The dose
escalation part will explore the safety of escalating doses of
BNT313 as monotherapy. The expansion part is planned to provide
additional safety and initial antitumor activity information on the
selected dose regimen for BNT313 monotherapy in selected tumor
indications, as well as more detailed data related to the mode of
action.
Corporate Updates
A key component of BioNTech’s corporate strategy
is strengthening the Company’s technology platforms, digital
capabilities and infrastructure through select strategic
partnerships and acquisitions. In April 2022, BioNTech was granted
a pandemic preparedness contract by the Federal Republic of Germany
and the Company entered into an exclusive research collaboration
with Matinas BioPharma Holdings, Inc. (“Matinas BioPharma”).
- In June 2022, BioNTech began construction of its first
Africa-based mRNA vaccine manufacturing facility in Kigali, Rwanda,
with a target for the first set of manufacturing BioNTainers to be
delivered to the site by the end of 2022. The facility will
initially include two BioNTainers equipped to manufacture a range
of mRNA-based vaccines targeted to the needs of the African Union
member states, including potentially the COVID-19 vaccine and
investigational malaria and tuberculosis vaccine candidates if
approved or authorized by regulatory authorities. The Company
believes the estimated initial annual capacity of, for example, the
COVID-19 vaccine may be as high as approximately 50 million doses
and manufacturing in the BioNTainers could commence as soon as
approximately 12 to 18 months after their installation.
BioNTech also provides an update on key
Supervisory Board developments and the status of the return of
capital to shareholders
- In June 2022, at the Annual General Meeting (AGM) the Company's
shareholders voted to reappoint Helmut Jeggle as a member of the
Supervisory Board and appointed two additional Supervisory Board
members, Prof. Dr. Anja Morawietz and Prof. Dr. Rudolf Staudigl. In
a meeting following the AGM, the Supervisory Board re-elected
Helmut Jeggle as its Chairman. All three members will serve in
their roles until the 2026 AGM.
- In June 2022, at the Annual General Meeting, the Company’s
shareholders approved the proposed special cash dividend of €2.00
per ordinary share (including those held in the form of ADSs),
which led to an aggregate payment of €484.3 million.
- During the three months ended June 30, 2022, 2,078,207 American
Depositary Shares (ADSs) were repurchased under the Company's share
repurchase program at an average price of $145.65, for total
consideration of $302.7 million (€286.9 million).
In light of the potential energy supply issues
in Europe, BioNTech is evaluating its ongoing mitigation efforts to
ensure business continuity.
- BioNTech monitors the natural gas supply situation as part of
its regular business continuity management and is evaluating
possible additional energy supply measures. BioNTech’s commercial
production of its COVID-19 vaccine is currently run on natural gas,
but the Company expects that it could be powered by alternative
fuel sources without interruption, if needed. According to the
Company’s most recent information and analyses, commercial mRNA
manufacturing in BioNTech’s facilities is not expected to be
impacted by a natural gas shortage, such as the current one.
Nonetheless, the Company cannot predict with certainty the impact
that a continuing or more severe natural gas shortage would have on
its operations. BioNTech’s R&D and clinical development
activities are currently dependent on gas, and the Company is
putting measures in place to mitigate related risks. BioNTech is
also currently evaluating the impact to its partners, including
Pfizer, suppliers and other service providers. BioNTech is
proactively engaging with collaboration partners and governmental
authorities to mitigate adverse impacts from any potential energy
shortage.
Environmental, Social, and Governance
(ESG)
The rating agency ISS ESG, part of the
Institutional Shareholder Services group (ISS) reiterated
BioNTech's “Prime” ESG rating. BioNTech improved its rating from
"C+" to "B-" compared to the previous year and remains in the top
10% of the biopharmaceutical industry, according to the ISS ESG
Rating.
Conference Call and Webcast
Information
BioNTech invites investors and the general
public to join a conference call and webcast with investment
analysts on the same day 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 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. It is recommended to
register at least a day in advance. 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.de/. 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.de
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including, 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; 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 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, the period during which the
results of the trials will become available and BioNTech's research
and development programs; the timing of and BioNTech's ability to
obtain and maintain regulatory approval for BioNTech's product
candidates; the ability of BNT162b2 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 personal injury or death arising from the use of
BioNTech's COVID-19 vaccine and other products and product
candidates developed or manufactured by us; BioNTech's ability to
progress BioNTech's Malaria, Tuberculosis and HIV programs,
including timing for selecting clinical candidates for these
programs and the commencement of a clinical trial, as well as any
data readouts; the development of sustainable vaccine production
and supply solutions on the African continent, including its
BioNTainers, and the nature and feasibility of these solutions;
BioNTech's estimates of vaccine revenues, and projections of
estimated research and development expenses, selling, general and
administrative expenses, capital expenditures, and income taxes;
BioNTech's ability and that of BioNTech's collaborators to
commercialize and market BioNTech's product candidates, if
approved, including BioNTech's COVID-19 vaccine; BioNTech's ability
to manage BioNTech's 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; and other factors not known to BioNTech at this time.
In some cases, forward-looking statements can be identified by
terminology such as “will,” “may,” “should,” “expects,” “intends,”
“plans,” “aims,” “anticipates,” “believes,” “estimates,”
“predicts,” “potential,” “continue,” or the negative of these terms
or other comparable terminology, although not all forward-looking
statements contain these words. The forward-looking statements in
this press release are neither promises nor guarantees, and you
should not place undue reliance on these forward-looking statements
because they involve known and unknown risks, uncertainties, and
other factors, many of which are beyond BioNTech’s control and
which could cause actual results to differ materially from those
expressed or implied by these forward-looking statements. You
should review the risks and uncertainties described under the
heading “Risk Factors” in BioNTech's quarterly report on Form 6-K
for the quarter ended June 30, 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.
CONTACTS
Investor RelationsSylke Maas,
Ph.D. VP Investor Relations & Strategy Tel: +49 (0)6131 9084
1074 E-mail: Investors@biontech.de
Media RelationsJasmina AlatovicVP Corporate
Communications Tel: +49 (0)6131 9084 1513
E-mail: Media@biontech.de
Interim Condensed Consolidated Statements
of Profit or Loss
|
Three months ended June 30, |
Six months ended June 30, |
|
2022 |
2021 |
2022 |
2021 |
(in
millions, except per share data) |
(unaudited) |
(unaudited) |
(unaudited) |
(unaudited) |
|
|
|
|
|
Revenues |
|
|
|
|
Commercial revenues |
€3,166.3 |
€5,280.5 |
€9,528.5 |
€7,3 08.0 |
Research & development revenues |
30.2 |
28.0 |
42.6 |
48.9 |
Total revenues |
€3,196.5 |
€5,308.5 |
€9,571.1 |
€7,356.9 |
|
|
|
|
|
Cost of sales |
(764.6) |
(883.8) |
(2,058.7) |
(1,116.9) |
Research and development expenses |
(399.6) |
(201.1) |
(685.4) |
(417.3) |
Sales and marketing expenses |
(17.8) |
(13.3) |
(32.1) |
(22.0) |
General and administrative expenses |
(130.0) |
(47.8) |
(220.8) |
(86.7) |
Other operating expenses |
(240.7) |
(0.3) |
(309.5) |
(0.9) |
Other operating income |
565.8 |
36.2 |
697.7 |
147.5 |
Operating income |
€2,209.6 |
€4,198.4 |
€6,962.3 |
€5,860.6 |
|
|
|
|
|
Finance income |
115.5 |
0.3 |
387.6 |
24.8 |
Finance expenses |
(5.8) |
(175.9) |
(12.5) |
(220.3) |
Profit before tax |
€2,319.3 |
€4,022.8 |
€7,337.4 |
€5,665.1 |
|
|
|
|
|
Income
taxes |
(647.3) |
(1,235.6) |
(1,966.6) |
(1,749.8) |
Profit for the
period |
€1,672.0 |
€2,787.2 |
€5,370.8 |
€3,915.3 |
|
|
|
|
|
Earnings per share |
|
|
|
|
Basic profit for the period per share |
€6.86 |
€11.42 |
€22.00 |
€16.07 |
Diluted
profit for the period per share |
€6.45 |
€10.77 |
€20.69 |
€15.14 |
Interim Condensed Consolidated Statements
of Financial Position
|
|
|
June 30, |
December 31, |
(in
millions) |
|
|
2022 |
2021 |
Assets |
|
|
(unaudited) |
|
Non-current assets |
|
|
|
|
Intangible assets |
|
|
€221.4 |
€202.4 |
Property, plant and equipment |
|
|
420.4 |
322.5 |
Right-of-use assets |
|
|
243.7 |
197.9 |
Other financial assets |
|
|
51.5 |
21.3 |
Other assets |
|
|
0.9 |
0.8 |
Deferred expenses |
|
|
9.4 |
13.6 |
Total non-current assets |
|
|
€947.3 |
€758.5 |
Current assets |
|
|
|
|
Inventories |
|
|
367.7 |
502.5 |
Trade and other receivables |
|
|
10,382.9 |
12,381.7 |
Other financial assets |
|
|
0.1 |
381.6 |
Other assets |
|
|
46.6 |
64.9 |
Income tax assets |
|
|
0.4 |
0.4 |
Deferred expenses |
|
|
75.6 |
48.5 |
Cash and cash equivalents |
|
|
9,334.8 |
1,692.7 |
Total current assets |
|
|
€20,208.1 |
€15,072.3 |
Total assets |
|
|
€21,155.4 |
€15,830.8 |
Equity and liabilities |
|
|
|
|
Equity |
|
|
|
|
Share capital |
|
|
248.6 |
246.3 |
Capital reserve |
|
|
1,689.8 |
1,674.4 |
Treasury shares |
|
|
(5.9) |
(3.8) |
Retained earnings |
|
|
14,769.4 |
9,882.9 |
Other reserves |
|
|
128.8 |
93.9 |
Total equity |
|
|
€16,830.7 |
€11,893.7 |
Non-current
liabilities |
|
|
|
|
Loans and borrowings |
|
|
206.6 |
171.6 |
Other financial liabilities |
|
|
6.1 |
6.1 |
Income tax liabilities |
|
|
6.8 |
4.4 |
Provisions |
|
|
7.3 |
184.9 |
Contract liabilities |
|
|
55.9 |
9.0 |
Other liabilities |
|
|
17.9 |
12.8 |
Deferred
tax liabilities |
|
|
100.4 |
66.7 |
Total non-current liabilities |
|
|
€401.0 |
€455.5 |
Current liabilities |
|
|
|
|
Loans and borrowings |
|
|
32.3 |
129.9 |
Trade payables |
|
|
291.1 |
160.0 |
Other financial liabilities |
|
|
807.3 |
1,190.4 |
Government grants |
|
|
3.0 |
3.0 |
Refund liabilities |
|
|
— |
90.0 |
Income tax liabilities |
|
|
1,417.9 |
1,568.9 |
Provisions |
|
|
596.2 |
110.2 |
Contract liabilities |
|
|
656.3 |
186.1 |
Other
liabilities |
|
|
119.6 |
43.1 |
Total current liabilities |
|
|
€3,923.7 |
€3,481.6 |
Total liabilities |
|
|
€4,324.7 |
€3,937.1 |
Total equity and liabilities |
|
|
€21,155.4 |
€15,830.8 |
Interim Condensed Consolidated Statements
of Cash Flows
|
|
Three months ended June 30, |
Six months ended June, 30 |
|
|
2022 |
2021 |
2022 |
2021 |
(in millions) |
|
(unaudited) |
(unaudited) |
(unaudited) |
(unaudited) |
Operating activities |
|
|
|
|
|
Profit for the period |
|
€1,672.0 |
€2,787.2 |
€5,370.8 |
€3,915.3 |
Income
taxes |
|
647.3 |
1,235.6 |
1,966.6 |
1,749.8 |
Profit before tax |
|
€2,319.3 |
€4,022.8 |
€7,337.4 |
€5,665.1 |
Adjustments to reconcile profit before
tax to net cash flows: |
|
|
|
|
|
Depreciation and amortization of property, plant, equipment,
intangible assets and right-of-use assets |
|
33.2 |
16.4 |
60.8 |
29.4 |
Share-based payment expense |
|
12.6 |
22.0 |
22.0 |
39.3 |
Net foreign exchange differences |
|
(344.6) |
(70.1) |
(338.5) |
(101.3) |
Gain on disposal of property, plant and equipment |
|
0.2 |
0.2 |
0.2 |
0.4 |
Finance income |
|
(1.5) |
(0.3) |
(218.8) |
(0.6) |
Finance expense |
|
5.8 |
175.6 |
12.5 |
220.3 |
Movements in government grants |
|
— |
(20.9) |
— |
(88.8) |
Net loss on derivative instruments at fair value through profit or
loss |
|
86.5 |
— |
84.6 |
— |
Working capital adjustments: |
|
|
|
|
|
Decrease / (increase) in trade and other receivables, contract
assets and other assets |
|
3,174.8 |
(4,651.0) |
2,771.3 |
(6,751.5) |
Decrease / (increase) in inventories |
|
91.6 |
(158.5) |
134.8 |
(241.3) |
(Decrease) / increase in trade payables, other financial
liabilities, other liabilities, contract liabilities, refund
liabilities and provisions |
|
(663.1) |
565.5 |
194.4 |
821.0 |
Interest received |
|
1.5 |
0.3 |
2.2 |
0.6 |
Interest paid |
|
(5.8) |
(2.1) |
(12.2) |
(3.9) |
Income
tax paid |
|
(791.4) |
(0.2) |
(2,081.4) |
(0.3) |
Net cash flows from / (used in) operating
activities |
|
€3,919.1 |
€(100.3) |
€7,969.3 |
€(411.6) |
|
|
|
|
|
|
Investing
activities |
|
|
|
|
|
Purchase of property, plant and
equipment |
|
(70.6) |
(25.9) |
(114.7) |
(47.6) |
Proceeds from sale of property, plant
and equipment |
|
— |
0.3 |
— |
1.2 |
Purchase of intangible assets and
right-of-use assets |
|
(4.8) |
(4.2) |
(21.5) |
(11.7) |
Purchase of financial instruments |
|
(3.0) |
— |
(30.0) |
— |
Proceeds from maturity of other
financial assets |
|
— |
— |
375.2 |
— |
Net cash flows from / (used in) investing
activities |
|
€(78.4) |
€(29.8) |
€209.0 |
€(58.1) |
|
|
|
|
|
|
Financing
activities |
|
|
|
|
|
Proceeds from issuance of share capital
and treasury shares, net of costs |
|
— |
160.9 |
110.5 |
160.9 |
Proceeds from loans and borrowings |
|
0.2 |
— |
0.2 |
— |
Repayment of loans and borrowings |
|
— |
(0.7) |
(18.8) |
(1.4) |
Payments related to lease
liabilities |
|
(10.5) |
(7.3) |
(21.9) |
(11.1) |
Share repurchase program |
|
(286.9) |
— |
(286.9) |
— |
Dividends |
|
(484.3) |
— |
(484.3) |
— |
Net cash flows from / (used in) financing
activities |
|
€(781.5) |
€152.9 |
€(701.2) |
€148.4 |
|
|
|
|
|
|
Net increase / (decrease) in cash and
cash equivalents |
|
3,059.2 |
22.8 |
7,477.1 |
(321.3) |
Change in cash and cash equivalents
resulting from exchange rate differences |
|
111.5 |
(0.2) |
165.0 |
25.2 |
Cash
and cash equivalents at the beginning of the period |
|
6,164.1 |
891.5 |
1,692.7 |
1,210.2 |
Cash and cash equivalents at June 30 |
|
€9,334.8 |
€914.1 |
€9,334.8 |
€914.1 |
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