BioNTech Announces Fourth Quarter and Full Year 2023 Financial
Results and Corporate Update
- Advanced oncology pipeline in mid- and late-stage with plans to
have ten or more potentially registrational oncology trials running
by the end of 2024
- Aiming for first oncology launch in 2026 and ten indication
approvals by 2030 as part of BioNTech's strategy to develop
combinatorial and synergistic therapeutic approaches
- Entered strategic collaborations with Biotheus, DualityBio,
Medilink and OncoC4 to complement clinical oncology pipeline with
innovative antibody-drug conjugate (ADC) and immuno-modulatory
programs
- Annemarie Hanekamp appointed as Chief Commercial Officer
effective July 1, 2024
- Delivered over 400 million COVID-19 vaccine doses worldwide in
2023, including successfully launched XBB.1.5 variant-adapted
monovalent COVID-19 vaccine
- Progressed three infectious disease vaccine candidates into
clinical evaluation, leveraging BioNTech's mRNA technology and
expertise
- Fourth quarter and full year 2023 revenues of €1.5 billion and
€3.8 billion, respectively
- Full year net profit of €0.9 billion and fully diluted
earnings per share of €3.83 ($4.141)
- Strong financial position with €17.7 billion in cash, cash
equivalents and security investments
- 2024 revenue guidance of €2.5 billion to
€3.1 billion
Conference call and webcast scheduled for
March 20, 2024, at 8:00 a.m. ET (1:00 p.m. CET)
MAINZ, Germany, March 20, 2024 (GLOBE
NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or
“the Company”) today reported financial results for the three
months and full year ended December 31, 2023, and provided an
update on its corporate progress.
“2023 was another year of good performance for
BioNTech. We have maintained our leading position in the COVID-19
vaccine market which lays the foundation for establishing a
sustainable respiratory vaccines business. In oncology, we have
strengthened our core competencies by entering into several
partnerships and have made numerous clinical advances. Today, our
oncology pipeline encompasses multiple candidates in mid- and
late-stage clinical development, including investigational ADCs,
mRNA vaccines and innovative immunotherapies,”
said Prof. Ugur Sahin, M.D., CEO and
Co-Founder of BioNTech. “Our goal is to achieve product
approvals in ten oncological indications by 2030 and with this
improve the treatment options for patients around the globe.”
Financial Review for the Fourth Quarter and Full Year
2023 Financial Results
in millions €, except per share data |
Fourth Quarter 2023 |
Fourth Quarter 2022 |
Full Year 2023 |
Full Year 2022 |
Total Revenues |
1,479.0 |
4,278.3 |
3,819.0 |
17,310.6 |
Net Profit |
457.9 |
2,278.7 |
930.3 |
9,434.4 |
Diluted Earnings per Share |
1.90 |
9.26 |
3.83 |
37.77 |
Total revenues reported were
€1,479.0 million for the three months ended December 31,
2023, compared to €4,278.3 million for the comparative prior
year period. For the year ended December 31, 2023, total
revenues were €3,819.0 million, compared to €17,310.6 million for
the comparative prior year period. Inventory write-downs by
BioNTech's collaboration partner Pfizer, Inc. (“Pfizer”) reduced
BioNTech's revenues by €291.3 million and €906.7 million
for the three and twelve months ended December 31, 2023,
respectively.
Cost of sales were €179.1
million for the three months ended December 31, 2023, compared
to €183.5 million for the comparative prior year period. For
the year ended December 31, 2023, cost of sales were €599.8
million, compared to €2,995.0 million for the comparative prior
year period. The change was mainly caused by the decrease in
COVID-19 vaccine sales.
Research and development
(R&D) expenses were €577.8 million for the three months ended
December 31, 2023, compared to €509.8 million for the
comparative prior year period. For the year ended December 31,
2023, research and development expenses were €1,783.1 million,
compared to €1,537.0 million for the comparative prior year
period. R&D expenses are mainly influenced by progressing
clinical studies for pipeline candidates as well as by our newly
acquired product candidates and the development of variant-adapted
COVID-19 vaccines. The increase was further driven by an increase
in wages, benefits and social security expenses resulting from an
increase in headcount.
General and administrative
(G&A) expenses reached €124.3 million for the three months
ended December 31, 2023, compared to €119.9 million for the
comparative prior year period. For the year ended December 31,
2023, G&A expenses were €495.0 million, compared to €481.7
million for the comparative prior year period. G&A
expenses were mainly influenced by increased expenses for IT
services as well as by wages, benefits and social security expenses
resulting from an increase in headcount.
Income taxes were accrued in an
amount of €205.3 million for the three months ended
December 31, 2023, compared to €893.9 million accrued for the
comparative prior year period. For the year ended December 31,
2023, income taxes were accrued with an amount of €255.8 million,
compared to €3,519.7 million accrued for the comparative prior year
period. The derived annual effective income tax rate for the year
ended December 31, 2023, was 21.6%.
Net profit was €457.9 million
for the three months ended December 31, 2023, compared to
€2,278.7 million for the comparative prior year period. For
the year ended December 31, 2023, net profit was €930.3
million, compared to €9,434.4 million net profit for the
comparative prior year period.
Cash and cash equivalents as well as
security investments2 as of December 31, 2023, reached
€17,653.4 million, comprising €11,663.7 million cash and cash
equivalents and €5,989.0 million security investments,
respectively.
Diluted earnings per share was
€1.90 for the three months ended December 31, 2023, compared
to diluted earnings per share of €9.26 for the comparative prior
year period. For the year ended December 31, 2023, diluted
earnings per share were €3.83, compared to €37.77 diluted earnings
per share for the comparative prior year period.
Shares outstanding as of
December 31, 2023, were 237,725,735, excluding 10,826,465 shares
held in treasury.
In March 2023, the Management Board and
Supervisory Board authorized the 2023 share repurchase program,
under which BioNTech was permitted to purchase ADSs, each
representing one ordinary share, with a value of up to
$0.5 billion, which started June 2, 2023, and concluded
on September 18, 2023. During the three months ended
December 31, 2023, 114,513 ADSs were repurchased under the
share repurchase program at an average price of $112.22 (€105.07),
for total consideration of $12.9 million (€12.0 million).
For the year ended December 31, 2023, a total of 4,646,965
ADSs were repurchased related to the 2023 program at an average
price of $107.58 (€98.24), for total consideration of
$0.5 billion (€456.5 million).
“In 2023, we strengthened our financial position
while concurrently progressing our clinical pipeline of
immunotherapies and executing acquisitions and collaborations.
Looking ahead to 2024, we will maintain a prudent capital
allocation strategy as we invest and execute in our maturing
pipeline and prepare for our first potential oncology launches,”
said Jens Holstein, CFO of BioNTech. “Our COVID-19
vaccine franchise is expected to remain an important cash
contributor in 2024. We believe our solid financial position will
enable us to push forward with our long-term strategy to develop
novel therapies against cancer, infectious and other severe
diseases thereby generating added value for patients, society,
investors and the Company.”
Outlook for the 2024 Financial
Year
The Company's outlook contains the following
components:
Total revenues for the 2024 financial year |
€2.5 billion - €3.1 billion |
BioNTech expects group revenue for the full 2024
financial year to be in the range of €2.5 - €3.1 billion. The
range reflects certain assumptions, including, but not limited to,
expectations regarding: the timing and grant of regulatory
approvals and recommendations, COVID-19 vaccine uptake and price
levels, inventory write-downs by BioNTech's collaboration partner
Pfizer that would negatively influence the Company's revenues,
seasonal variations in SARS-CoV-2 circulation and vaccination
uptake which are expected to lead to demand peaks in the autumn and
winter compared to other seasons, revenues from a pandemic
preparedness contract with the German government as well as
revenues from BioNTech Group service businesses, namely InstaDeep,
JPT Peptide Technologies GmbH and in Idar-Oberstein at BioNTech
Innovative Manufacturing Services GmbH. Generally, the Company
continues to remain largely dependent on revenues generated in its
collaboration partner’s territories in 2024.
Planned 2024 Financial Year Expenses and
Capex3:
R&D expenses4 |
€2.4 billion - €2.6 billion |
SG&A expenses5 |
€700 million - €800 million |
Capital expenditures for operating activities |
€400 million - €500 million |
BioNTech expects to continue to focus
investments on R&D and scaling the business for commercial
readiness in oncology, while continuing to be cost disciplined.
Strategic capital allocation will continue to be an important
driver of the Company's trajectory. As part of BioNTech's strategy,
the Company may continue to evaluate appropriate corporate
development opportunities with the aim of driving sustainable
long-term growth and create future value.
The full audited consolidated financial
statements as of and for the year ended December 31, 2023, can be
found in BioNTech’s Annual Report on Form 20-F for the period ended
December 31, 2023, filed today with the United States Securities
and Exchange Commission (“SEC”) and available at
https://www.sec.gov/ (the “Annual Report”).
Endnotes
1 Calculated applying the average foreign
exchange rate for the year ended December 31, 2023, as
published by the German Central Bank (Deutsche Bundesbank).2 The
contractual settlement of the gross profit share has a temporal
offset of more than one calendar quarter. As Pfizer’s financial
quarter for subsidiaries outside the United States differs from
BioNTech's, it creates an additional time lag between the
recognition of revenues and the payment receipt.3 Numbers reflect
current base case projections and are calculated based on constant
currency rates, and exclude external risks that are not yet known
and/or quantifiable, including, but not limited to, the effects of
ongoing and/or future legal disputes or related activity.4 Numbers
include effects identified from additional collaborations or
potential M&A transactions to the extent disclosed and are
subject to update due to future developments.5 Anticipated expenses
related to external legal advice in connection with certain legal
litigations are not reflected in SG&A but in other operating
expenses. Guidance does not include and may be impacted by
potential payments resulting from the outcomes of ongoing or future
legal disputes or related activity, such as judgments or
settlements.
Operational Review of the Fourth Quarter
2023, Key Post Period-End Events and 2024 Outlook
Omicron XBB.1.5-adapted Monovalent
COVID-19 Vaccine (COMIRNATY®)
- BioNTech and Pfizer developed, manufactured and delivered their
Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, which has
received multiple regulatory approvals, including full approvals,
authorizations for emergency or temporary use, or marketing
authorizations in more than 40 countries and regions. In 2023,
BioNTech and Pfizer delivered more than 400 million COVID-19
vaccine doses worldwide.
COVID-19 – Influenza Combination Vaccine
Program
BNT162b2 + BNT161 is an
mRNA-based combination vaccine program against COVID-19 and
influenza being developed in collaboration with Pfizer.
- Topline data from the Phase 1/2 trial (NCT05596734)
demonstrated robust immune responses to influenza A, influenza B,
and SARS-CoV-2 strains and that the safety profile of the
candidates was consistent with that of the companies’ COVID-19
vaccine. A Phase 3 clinical trial (NCT06178991) was initiated in
December 2023.
Select Oncology Pipeline
Highlights
BioNTech's vision for oncology is to bring novel
therapies to patients and address the continuum of cancer
treatment, from early to late lines. Addressing root causes of
cancer treatment failure such as cancer heterogeneity and
interindividual variability is the core of its strategy. To augment
anti-tumor activity and to counteract resistance mechanisms,
BioNTech seeks to combine compounds with non-overlapping,
synergistic mechanisms of action.
In 2023, the Company’s pipeline continued to
mature, with various programs advancing towards later stages of
development. BioNTech’s oncology pipeline currently contains 10
ongoing Phase 2 and 3 trials. In 2024, the Company expects to
continue building its pipeline towards its planned first oncology
launch in 2026. BioNTech aims to have ten indication approvals by
2030.
Antibody-Drug Conjugate (ADC) Programs
BNT323/DB-1303 is an ADC
candidate targeting Human Epidermal Growth Factor 2 (HER2) that is
being developed in collaboration with Duality Biologics (Suzhou)
Co. Ltd. (“DualityBio”).
- An ongoing randomized, multi-center, open-label Phase 3
clinical trial (NCT06018337) is recruiting to evaluate
BNT323/DB1303 versus the investigator's choice of chemotherapy in
advanced or metastatic Hormone Receptor (HR)+, HER2-low breast
cancer subjects whose disease has progressed on at least two lines
of prior endocrine therapy or within six months of first-line
endocrine therapy + cyclin-dependent kinase 4/6 (CDK4/6) inhibitor
therapy without prior chemotherapy. The first patient was dosed in
January 2024 and the trial aims to enroll 532 patients.
- A potentially registrational single-arm trial enrolling
HER2-expressing (immunohistochemistry score (“IHC”) 3+, 2+, 1+ or
in situ hybridization (“ISH”)-positivet) patients with endometrial
carcinoma is ongoing and plans to enroIl 140 patients.
- In December 2023, the U.S. Food and Drug Administration (“FDA”)
granted Breakthrough Therapy designation for BNT323/DB-1303 for the
potential treatment of advanced endometrial cancer in patients
whose disease progressed on or after treatment with
immune-checkpoint inhibitors.
- First-in-human data from the ongoing Phase 1/2 trial
(NCT05150691) were presented at medical conferences in 2023,
indicating a manageable safety profile and anti-tumor activity in
patients with heavily pretreated HER2-expressing solid tumors,
including breast and endometrial cancer. Data from this trial
informed the decision to further evaluate this candidate in these
indications in the aforementioned studies.
- Additional trials with registrational potential are planned to
be initiated in 2024.
BNT325/DB-1305 is an ADC
candidate targeting Trophoblast Cell-surface Antigen 2 (“TROP2”)
that is being developed in collaboration with DualityBio.
- Data from the ongoing Phase 1/2 clinical trial (NCT05438329)
were presented at the 2023 European Society for Medical Oncology
(“ESMO”) Annual Meeting. The dose range with manageable safety
profile was determined. Encouraging preliminary activity was
observed in heavily pretreated patients with advanced/metastatic
solid tumors.
- In November 2023, two new cohorts were added to the study: one
to evaluate BNT325/DB-1305 monotherapy in cervical cancer, and one
to assess the combination of BNT325/DB-1305 with pembrolizumab in
non-small cell lung cancer (“NSCLC”).
- In January 2024, BioNTech and DualityBio received Fast Track
designation for BNT325/DB-1305 from the FDA for the treatment of
patients with platinum-resistant ovarian epithelial, fallopian
tube, or primary peritoneal cancer who have received one to three
prior systemic treatment regimens.
Next-Generation Immune Checkpoint
Immunomodulator Programs
BNT316/ONC-392 (gotistobart) is
an anti-CTLA-4 monoclonal antibody candidate being developed in
collaboration with OncoC4, Inc. (“OncoC4”).
- In June 2023, a Phase 3 clinical trial (NCT05671510) was
initiated to evaluate BNT316/ONC-392 (monotherapy in patients with
metastatic NSCLC whose disease progressed on anti-PD-1/PD-L1
antibody-based therapy.
- In November 2023, clinical data from the ongoing Phase 1/2
trial (NCT04140526) were presented at the Society for Immunotherapy
of Cancer (”SITC”) Annual Meeting in which BNT316/ONC-392 was
observed to have a manageable safety profile. The data also
included encouraging clinical activity observations in patients
with immunotherapy-resistant NSCLC, which informed the decision to
proceed the Phase 3 clinical trial.
- In December 2023, the first patient was dosed in a Phase 1/2
clinical trial (NCT05682443) to evaluate the efficacy and safety of
BNT316/ONC-392 in combination with the radioligand therapy,
lutetium (177Lu) vipivotide tetraxetan in patients with metastatic
castration-resistant prostate cancer (“mCRPC”) who have progressed
on an androgen receptor pathway inhibitor.
BNT311/GEN1046 (acasunlimab) is
a potential first-in-class bispecific antibody candidate combining
PD-L1 checkpoint inhibition with 4-1BB costimulatory activation
that is being developed in collaboration with Genmab S/A
(“Genmab”).
- Based on emerging clinical data, the companies are engaging
with health authorities on the design of a Phase 3 trial in
second-line NSCLC. The companies intend to share initial data at a
medical conference in the first half of 2024 from an ongoing Phase
2 randomized, open-label clinical trial (NCT05117242) evaluating
BNT311/GEN1046 as monotherapy and in combination with pembrolizumab
in patients with relapsed/refractory metastatic NSCLC and a tumor
PD-L1 expression of tumor proportion score of ≥1% after treatment
with standard-of-care therapy with an immune-checkpoint inhibitor.
The primary endpoint is objective response rate according to
Response Evaluation Criteria in Solid Tumors (“RECIST v1.1”).
Secondary endpoints include duration of response, time to response,
progression-free survival, overall survival and safety.
BNT312/GEN1042 is a potential
first-in-class bispecific antibody candidate designed to induce
conditional immune activation by crosslinking CD40 and 4-1BB
positive cells that is being developed in collaboration with
Genmab.
- The companies intend to share updated data at a medical
conference in the second half of 2024 from an ongoing Phase 1/2
dose-escalation clinical trial (NCT04083599) with expansion cohorts
evaluating safety and anti-tumor activity of BNT312/GEN1042 as
monotherapy and in combination therapies in patients with solid
tumors. The companies also expect to determine next steps for this
program in 2024.
BNT327/PM8002 is an anti-VEGF-A
antibody candidate fused to a humanized anti-PD-L1 VHH that is
being developed in collaboration with Biotheus Inc. (“Biotheus”).
BNT327/PM8002 is currently being evaluated in Phase 1 and Phase 2/3
clinical trials in China to assess the efficacy and safety of the
candidate as a monotherapy or in combination with chemotherapy in
various indications, including in first line small-cell lung cancer
(“SCLC”) and second-line Epidermal Growth Factor Receptor
(“EGFR”)-mutated NSCLC.
- Data from a Phase 1/2 clinical trial in advanced solid tumors
presented in 2023 indicate that BNT327/PM8002 monotherapy may have
antitumor activity and a manageable safety profile.
- Data from Phase 2 trials in patients with SCLC and
triple-negative breast cancer (“TNBC”) presented in 2023 indicate
that BNT327/PM8002 in combination with chemotherapy may have
encouraging antitumor activity and an acceptable toxicity profile
as second and first-line therapy, respectively.
- An Investigational New Drug (“IND”) application has been
accepted by the FDA for further studies in the United States.
Global trials are planned to start in 2024.
Cancer Vaccine Programs
BNT116 is based on BioNTech’s
FixVac platform, and is a wholly owned, systemically administered,
off-the-shelf uridine mRNA-lipoplex based cancer vaccine candidate
encoding six shared lung cancer associated antigens. BNT116 is
being evaluated for the treatment of advanced NSCLC.
- A randomized, controlled Phase 2 clinical trial (NCT05557591)
is ongoing to evaluate BNT116 in combination with cemiplimab versus
cemiplimab alone as first-line treatment in patients with advanced
NSCLC whose tumors express PD-L1 in ≥ 50% of tumor cells.
- In November 2023, data from the ongoing Phase 1 clinical trial
(NCT05142189) evaluating the safety, tolerability and preliminary
efficacy of BNT116 alone and in combination with cemiplimab or
chemotherapy were presented at the 2023 SITC Annual Meeting. BNT116
was observed to be generally well tolerated with an expected safety
profile as monotherapy and in combination with cemiplimab. In
heavily pretreated NSCLC patients, early clinical activity was
observed with treatment with BNT116 with the addition of cemiplimab
from cycle 3 onward.
- Additional data from a different cohort of this Phase 1
clinical trial evaluating BNT116 in combination with docetaxel in
patients with NSCLC that progressed on prior anti-PD(L)-1 therapy
will be presented at the 2024 American Association of Cancer
Research ("AACR") Annual Meeting in April 2024.
Autogene cevumeran (BNT122) is
an uridine mRNA-lipoplex based cancer vaccine candidate for
individualized neoantigen-specific immunotherapy ("iNeST") being
developed in collaboration with Genentech, Inc. ("Genentech"), a
member of the Roche Group (“Roche”).
- In October 2023, BioNTech announced the initiation of a Phase 2
trial (NCT05968326) evaluating the efficacy and safety of BNT122 in
combination with the anti-PD-L1 immune checkpoint inhibitor
atezolizumab and standard of care chemotherapy in patients with
resected pancreatic ductal adenocarcinoma ("PDAC").
- Follow-up data from the investigator-initiated Phase 1 trial in
patients with resected PDAC which informed and motivated the
Phase 2 trial, are due to be presented at the AACR Annual Meeting
in April 2024. The results of the Phase 1 trial were published in
Nature (Rojas et al., Nature 2023).
- An additional Phase 2 clinical trial is planned to be initiated
as early as 2024.
Cell Therapy Programs
BNT211 is a CAR-T cell product
candidate targeting Claudin-6 ("CLDN6")-positive solid tumors that
is combined with a CAR-T cell-amplifying RNA vaccine ("CARVac")
encoding CLDN6.
- An open-label, multi-center Phase 1/2 dose escalation and dose
expansion basket trial (NCT04503278) evaluating CLDN6 CAR-T cells
with or without a CLDN6 CARVac in CLDN6-positive relapsed or
refractory advanced solid tumors, including ovarian and testicular
cancers, is ongoing. Data from this trial were reported at several
conferences, including ASCO and ESMO 2023. Encouraging signs of
activity were observed. In several patients treated with CARVac, an
increased persistence of CLDN6 CAR-T cells was observed. The rate
of treatment-dependent adverse event was dose-dependent and further
evaluation is ongoing to determine the CLDN6 CAR T dose with
manageable safety.
- A pivotal Phase 2 clinical trial in relapsed/refractory germ
cell tumors is planned to start in 2024.
Select Infectious Disease Pipeline
Highlights
Beyond BioNTech’s portfolio of variant-adapted,
next-generation and combination respiratory programs, the Company
is developing vaccine modalities against multiple pathogens that
pose a threat to public health and have a significant global health
burden.
In 2023, BioNTech initiated three first-in-human
Phase 1 clinical trials leveraging its proprietary mRNA
prophylactic vaccine technology. These trials are for vaccine
candidates addressing shingles (NCT05703607), tuberculosis
(NCT05537038, Germany and NCT05547464, Republic of South Africa),
and mpox (NCT05988203).
Corporate Update for 2023 and Key Post
Period-End EventsIn 2023, BioNTech strategically forged a
series of complementary agreements and collaborations,
including:
- The acquisition of its long-time strategic collaboration
partner, InstaDeep Ltd (“InstaDeep”), which provides BioNTech with
capabilities to leverage artificial intelligence (AI) and machine
learning (ML) technologies across its therapeutic platforms and
operations. With this acquisition, BioNTech has added
industry-leading AI and ML capabilities and approximately 290
highly skilled professionals to its organization. InstaDeep is
operating as a London-based subsidiary of BioNTech.
- New collaborations with DualityBio and MediLink Therapeutics
(Suzhou) Co., Ltd. ("MediLink") which expanded BioNTech's
technology base into ADCs, and collaborations with OncoC4 and
Biotheus that have complemented the Company's pipeline with
mid-to-late-stage novel immunomodulators.
- A strategic partnership with the Government of the United
Kingdom ("UK") aiming to lead to personalized mRNA cancer
immunotherapies reaching up to 10,000 patients by 2030. BioNTech
also plans to invest in a research and development hub in
Cambridge, UK, which is expected to employ more than 70 additional
highly skilled scientists.
- A multi-year strategic partnership with the State of Victoria,
Australia, to set up and operate a clinical-scale mRNA
manufacturing facility through its BioNTainers, BioNTech’s modular,
state-of-the-art mRNA manufacturing solution, and to
establish an mRNA Innovation Center in Melbourne.
Over the last 12 months, BioNTech expanded its
organization in Asia, Africa, North America, Australia and Europe.
The Company increased its research and development and production
capabilities and completed construction of its first proprietary
plasmid DNA manufacturing facility in Marburg, Germany. BioNTech
also delivered and set up the first BioNTainer for its site in
Kigali, Rwanda.
In February 2024, BioNTech entered into a
strategic collaboration with Autolus Therapeutics plc
("Autolus") aimed at advancing both companies’ autologous CAR-T
programs towards commercialization, pending regulatory
authorizations. The collaboration also grants BioNTech the option
to access a suite of Autolus’ target binders and cell programming
technologies to support BioNTech’s development of in vivo cell
therapy and ADC candidates.
In March 2024, BioNTech announced that Sean
Marett, Chief Business and Commercial Officer, will retire as
planned from the Management Board of BioNTech. As of July 1, 2024,
Sean Marett will continue as a specialist advisor to the Company at
least until the end of the year. As announced earlier today,
Annemarie Hanekamp will be joining the Company's Management Board
as Chief Commercial Officer on July 1, 2024. Sean Marett’s
responsibilities as Chief Business Officer are being gradually
transferred to James Ryan, Ph.D., Chief Legal Officer, who joined
the Management Board in September 2023 and who will also take on
the role as Chief Business Officer of BioNTech at the end of the
transition phase and upon Sean Marett’s retirement.
Environmental, Social, and Governance
(ESG)
In February 2024, the Company’s near-term
science-based emissions reduction targets were approved by the
Science Based Targets initiative (“SBTi”). This validation
underscores the ambitious nature of BioNTech’s scope 1 and scope 2
climate targets and is intended to align with the United Nations'
Paris Climate Agreement to limit global warming to 1.5 degrees
Celsius above pre-industrial levels. More information on BioNTech’s
Scope 1, 2 and 3 targets can be found in the Company's press
release dated February 12, 2024.
BioNTech's performance on environmental, social,
and governance matters is regularly assessed by external rating
agencies. The Institutional Shareholder Services Group ("ISS")
currently assigns BioNTech a "Prime" ESG rating: the Company has
received an overall corporate rating of B-, which is among the top
10% of all rated companies in the pharmaceutical and biotechnology
sector. In the ISS Governance Quality Score, BioNTech stands at 5
on a risk scale of 1 (low risk) to 10 (high risk). S&P Global
Ratings has rated BioNTech in the S&P Corporate Sustainability
Assessment 2023 ("CSA") with an S&P Global CSA score of 45
(2022: 32) out of 100. Morningstar Sustainalytics has given
BioNTech a Sustainalytics ESG rating of 24.1 (2022: 22.3), which
corresponds to a "medium risk", the third of five risk levels
(negligible, low, medium, high and severe).
BioNTech publishes its ESG report
(Sustainability Report 2023) today, March 20, 2024. The report is
being made available on the Investors' section of BioNTech’s
website.
Upcoming Investor and Analyst
Events
- Annual General Meeting: May 17, 2024
- Innovation Series (Digital & AI Day): October 1, 2024
- Innovation Series: November 14, 2024
Conference Call and Webcast
Information
BioNTech invites investors and the general
public to join a conference call and webcast with investment
analysts today, March 20, 2024, at 8:00 a.m. ET (1:00 p.m. CET) to
report its financial results and provide a corporate update for the
fourth quarter and financial year 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 Investors' 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 global next generation
immunotherapy company pioneering novel therapies for cancer and
other serious diseases. BioNTech exploits a wide array of
computational discovery and therapeutic drug platforms for the
rapid development of novel biopharmaceuticals. Its broad portfolio
of oncology product candidates includes individualized and
off-the-shelf mRNA-based therapies, innovative chimeric antigen
receptor (CAR) T cells, several protein-based therapeutics,
including bispecific immune checkpoint modulators, targeted cancer
antibodies and antibody-drug conjugate (ADC) therapeutics, as well
as small molecules. Based on its deep expertise in mRNA vaccine
development and in-house manufacturing capabilities, BioNTech and
its collaborators are developing multiple mRNA vaccine candidates
for a range of infectious diseases alongside its diverse oncology
pipeline. BioNTech has established a broad set of relationships
with multiple global and specialized pharmaceutical collaborators,
including Biotheus, DualityBio, Fosun Pharma, Genentech, a member
of the Roche Group, Genevant, Genmab, OncoC4, Pfizer and
Regeneron.
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,
enrollment, and completion of studies or trials and related
preparatory work and the availability of results, and the timing
and outcome of applications for regulatory approvals and marketing
authorizations; BioNTech's expectations with respect to its
intellectual property; the impact of BioNTech's collaboration and
licensing agreements and its acquisition of InstaDeep Ltd.; the
development, nature and feasibility of sustainable vaccine
production and supply solutions; and BioNTech's estimates of
revenues, research and development expenses, cost of sales, general
and administrative expenses, and capital expenditures for operating
activities. 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
regarding its COVID-19 vaccine 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 its production capabilities
and manufacture its products, including target COVID-19 vaccine
production levels, and 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, 2023 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 RelationsVictoria Meissner, M.D.+1 617
528 8293Investors@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, |
|
2023 |
2022 |
2023 |
2022 |
2021 |
(in millions €, except per share
data) |
(unaudited) |
(unaudited) |
|
|
|
Revenues |
|
|
|
|
|
Commercial revenues |
1,478.9 |
4,271.3 |
3,815.5 |
17,194.6 |
18,874.0 |
Research & development revenues |
0.1 |
7.0 |
3.5 |
116.0 |
102.7 |
Total revenues |
1,479.0 |
4,278.3 |
3,819.0 |
17,310.6 |
18,976.7 |
|
|
|
|
|
|
Cost of sales |
(179.1) |
(183.5) |
(599.8) |
(2,995.0) |
(2,911.5) |
Research and development expenses |
(577.8) |
(509.8) |
(1,783.1) |
(1,537.0) |
(949.2) |
Sales and marketing expenses |
(18.0) |
(14.6) |
(62.7) |
(59.5) |
(50.4) |
General and administrative expenses |
(124.3) |
(119.9) |
(495.0) |
(481.7) |
(276.8) |
Other operating expenses (1) |
(57.6) |
(379.2) |
(293.0) |
(410.0) |
(103.4) |
Other operating income (1) |
4.0 |
221.6 |
105.0 |
815.3 |
598.4 |
Operating income |
526.2 |
3,292.9 |
690.4 |
12,642.7 |
15,283.8 |
|
|
|
|
|
|
Finance income |
162.2 |
38.8 |
519.6 |
330.3 |
67.7 |
Finance expenses |
(25.2) |
(159.1) |
(23.9) |
(18.9) |
(305.1) |
Profit before tax |
663.2 |
3,172.6 |
1,186.1 |
12,954.1 |
15,046.4 |
|
|
|
|
|
|
Income
taxes |
(205.3) |
(893.9) |
(255.8) |
(3,519.7) |
(4,753.9) |
Profit for the
period |
457.9 |
2,278.7 |
930.3 |
9,434.4 |
10,292.5 |
|
|
|
|
|
|
Earnings per share |
|
|
|
|
|
Basic earnings for the period per
share |
1.91 |
9.38 |
3.87 |
38.78 |
42.18 |
Diluted
earnings for the period per share |
1.90 |
9.26 |
3.83 |
37.77 |
39.63 |
(1) Adjustments to prior-year figures due to
change in functional allocation of general and administrative
expenses and other operating expenses
Statements of Financial
Position
|
|
December 31, |
December 31, |
(in millions
€) |
|
2023 |
2022 |
Assets |
|
|
|
Non-current assets |
|
|
|
Goodwill |
|
362.5 |
61.2 |
Other intangible assets |
|
804.1 |
158.5 |
Property, plant and equipment |
|
757.2 |
609.2 |
Right-of-use assets |
|
214.4 |
211.9 |
Other financial assets |
|
1,176.1 |
80.2 |
Other non-financial assets |
|
83.4 |
6.5 |
Deferred
tax assets |
|
81.3 |
229.6 |
Total non-current assets |
|
3,479.0 |
1,357.1 |
Current assets |
|
|
|
Inventories |
|
357.7 |
439.6 |
Trade and other receivables |
|
2,155.7 |
7,145.6 |
Contract assets |
|
4.9 |
— |
Other financial assets |
|
4,885.3 |
189.4 |
Other non-financial assets |
|
280.9 |
271.9 |
Income tax assets |
|
179.1 |
0.4 |
Cash and cash equivalents |
|
11,663.7 |
13,875.1 |
Total current assets |
|
19,527.3 |
21,922.0 |
Total assets |
|
23,006.3 |
23,279.1 |
|
|
|
|
Equity and liabilities |
|
|
|
Equity |
|
|
|
Share capital |
|
248.6 |
248.6 |
Capital reserve |
|
1,229.4 |
1,828.2 |
Treasury shares |
|
(10.8) |
(5.3) |
Retained earnings |
|
19,763.3 |
18,833.0 |
Other reserves |
|
(984.6) |
(848.9) |
Total equity |
|
20,245.9 |
20,055.6 |
Non-current
liabilities |
|
|
|
Lease liabilities, loans and
borrowings |
|
191.0 |
176.2 |
Other financial liabilities |
|
38.8 |
6.1 |
Income tax liabilities |
|
— |
10.4 |
Provisions |
|
8.8 |
8.6 |
Contract liabilities |
|
398.5 |
48.4 |
Other non-financial liabilities |
|
13.1 |
17.0 |
Deferred
tax liabilities |
|
39.7 |
6.2 |
Total non-current liabilities |
|
689.9 |
272.9 |
Current liabilities |
|
|
|
Lease liabilities, loans and
borrowings |
|
28.1 |
36.0 |
Trade payables and other payables |
|
354.0 |
204.1 |
Other financial liabilities |
|
415.2 |
785.1 |
Refund liabilities |
|
— |
24.4 |
Income tax liabilities |
|
525.5 |
595.9 |
Provisions |
|
269.3 |
367.2 |
Contract liabilities |
|
353.3 |
77.1 |
Other
non-financial liabilities |
|
125.1 |
860.8 |
Total current liabilities |
|
2,070.5 |
2,950.6 |
Total liabilities |
|
2,760.4 |
3,223.5 |
Total equity and liabilities |
|
23,006.3 |
23,279.1 |
Statements of Cash Flows
|
|
Three months ended December
31, |
Years ended December 31, |
|
|
2023 |
2022 |
2023 |
2022 |
2021 |
(in
millions €) |
|
(unaudited) |
(unaudited) |
|
|
|
Operating activities |
|
|
|
|
|
|
Profit for the period |
|
457.9 |
2,278.7 |
930.3 |
9,434.4 |
10,292.5 |
Income
taxes |
|
205.3 |
893.9 |
255.8 |
3,519.7 |
4,753.9 |
Profit before tax |
|
663.2 |
3,172.6 |
1,186.1 |
12,954.1 |
15,046.4 |
Adjustments to reconcile profit before tax
to net cash flows: |
|
|
|
|
|
|
Depreciation and amortization of property, plant, equipment,
intangible assets and right-of-use assets |
|
78.8 |
29.0 |
183.4 |
123.3 |
75.2 |
Share-based payment expenses |
|
14.2 |
22.2 |
51.4 |
108.6 |
93.9 |
Net foreign exchange differences |
|
66.3 |
847.8 |
(298.0) |
625.5 |
(387.5) |
Loss on disposal of property, plant and equipment |
|
0.2 |
0.2 |
3.8 |
0.6 |
4.6 |
Finance income excluding foreign exchange differences |
|
(162.2) |
(38.8) |
(519.6) |
(265.3) |
(1.5) |
Finance expense excluding foreign exchange differences |
|
3.4 |
2.1 |
7.9 |
18.9 |
305.2 |
Movements in government grants |
|
5.4 |
0.3 |
2.4 |
0.3 |
(89.0) |
Net (gain) / loss on derivative instruments at fair value through
profit or loss |
|
(21.2) |
(323.3) |
175.5 |
(241.0) |
57.3 |
Working capital adjustments: |
|
|
|
|
|
|
Decrease / (increase) in trade and other receivables, contract
assets and other assets |
|
(288.0) |
(646.8) |
5,374.0 |
4,369.9 |
(11,808.1) |
Decrease / (increase) in inventories |
|
58.0 |
(144.8) |
81.9 |
62.9 |
(438.4) |
Increase in trade payables, other financial liabilities, other
liabilities, contract liabilities, refund liabilities and
provisions |
|
412.8 |
(674.6) |
118.9 |
85.7 |
1,516.1 |
Interest received and realized gains from
cash and cash equivalents |
|
91.8 |
22.8 |
258.2 |
29.3 |
1.2 |
Interest paid and realized losses from
cash and cash equivalents |
|
(1.7) |
(5.0) |
(5.4) |
(21.5) |
(12.2) |
Income tax paid |
|
(65.1) |
(1,387.4) |
(482.9) |
(4,222.1) |
(3,457.9) |
Share-based payments |
|
(5.0) |
(47.1) |
(766.2) |
(51.8) |
(13.4) |
Net cash flows from operating activities |
|
850.9 |
829.2 |
5,371.4 |
13,577.4 |
889.7 |
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
Purchase of property, plant and
equipment |
|
(83.8) |
(136.6) |
(249.4) |
(329.2) |
(127.5) |
Proceeds from sale of property, plant and
equipment |
|
0.1 |
0.2 |
(0.7) |
0.6 |
3.4 |
Purchase of intangible assets and
right-of-use assets |
|
(106.5) |
(7.9) |
(455.4) |
(34.1) |
(26.5) |
Acquisition of subsidiaries and
businesses, net of cash acquired |
|
— |
— |
(336.9) |
— |
(20.8) |
Investment in other financial assets |
|
(3,418.2) |
(16.7) |
(7,128.4) |
(47.8) |
(19.5) |
Proceeds
from maturity of other financial assets |
|
913.3 |
— |
1,216.3 |
375.2 |
(375.2) |
Net cash flows used in investing activities |
|
(2,695.1) |
(161.0) |
(6,954.5) |
(35.3) |
(566.1) |
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
Proceeds from issuance of share capital
and treasury shares, net of costs |
|
— |
— |
— |
110.5 |
160.9 |
Proceeds from loans and borrowings |
|
0.2 |
0.2 |
0.3 |
0.8 |
— |
Repayment of loans and borrowings |
|
— |
— |
(0.1) |
(18.8) |
(52.6) |
Payments related to lease liabilities |
|
(12.3) |
(9.2) |
(40.3) |
(41.1) |
(14.1) |
Share repurchase program |
|
(0.8) |
(55.7) |
(738.5) |
(986.4) |
— |
Dividends |
|
— |
— |
— |
(484.3) |
— |
Net cash flows from / (used in) financing
activities |
|
(12.9) |
(64.7) |
(778.6) |
(1,419.3) |
94.2 |
|
|
|
|
|
|
|
Net increase / (decrease) in cash and cash
equivalents |
|
(1,857.1) |
603.5 |
(2,361.7) |
12,122.8 |
417.8 |
Change in cash and cash equivalents
resulting from exchange rate differences |
|
(15.4) |
(152.1) |
(14.5) |
60.1 |
64.7 |
Cash and
cash equivalents at the beginning of the period |
|
13,495.8 |
13,423.7 |
13,875.1 |
1,692.7 |
1,210.2 |
Cash and cash equivalents as of December 31 |
|
11,663.7 |
13,875.1 |
11,663.7 |
13,875.1 |
1,692.7 |
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