BioNTech Announces Third Quarter 2023 Financial Results and
Corporate Update
- Positive clinical data updates across multiple drug classes
including antibody-drug conjugate (ADC) candidates BNT323/DB-1303,
BNT325/DB-1305, CAR-T candidate BNT211, T cell therapy candidate
BNT221 and mRNA cancer vaccine candidate BNT116
- Progress across the oncology pipeline with multiple late-stage
trials initiated since third quarter start
- New and expanded strategic collaborations reflect BioNTech's
commitment to delivering transformational therapies for oncology
and infectious diseases
- Successful launches of Omicron XBB.1.5-adapted monovalent
COVID-19 vaccine in markets worldwide
- Updated 2023 COVID-19 vaccine revenue guidance of around €4
billion
- Guidance reduction of planned 2023 R&D expenses to €1.8-2.0
billion and SG&A expenses to €600-650 million
- First nine months of 20231 revenues of €2.3 billion2, net
profit of €472 million and diluted earnings per share of €1.94
($2.113)
Conference call and webcast scheduled for
November 6, 2023, at 8:00 am ET (2:00 pm CET)
MAINZ, Germany, November 6, 2023 (GLOBE
NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the
Company”) today reported financial results for the three and nine
months ended September 30, 2023, and provided an update on its
corporate progress.
“Over the last quarter, we complemented our
investigational pipeline with ADC candidates, initiated later-stage
clinical trials and presented significant data across modalities
including cancer vaccines, cell therapies, ADCs and immune
checkpoint modulators. Our strategy focuses on assembling a diverse
toolbox of complementary technologies to deliver novel therapies,
aiming to improve the standard-of-care for cancer patients,” said
Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “We
combine our internal innovation engine with a high-performance
partnership model to transform healthcare and improve patients'
quality of life.”
Financial Review for the Third Quarter and
First Nine Months of 2023
in millions €, except per share data |
Third Quarter 2023 |
Third Quarter 2022 |
Nine Months 2023 |
Nine Months 2022 |
Total Revenues2 |
895.3 |
3,461.2 |
2,340.0 |
13,032.3 |
Net Profit |
160.6 |
1,784.9 |
472.4 |
7,155.7 |
Diluted Earnings per Share |
0.67 |
6.98 |
1.94 |
27.70 |
Total revenues reported were €895.3
million2 for the three months ended September 30, 2023,
compared to €3,461.2 million for the comparative prior year
period. For the nine months ended September 30, 2023, total
revenues were €2,340.0 million2, compared to €13,032.3 million for
the comparative prior year period. Inventory write-downs by
BioNTech's collaboration partner Pfizer, Inc. ("Pfizer") reduced
BioNTech's revenues by €507.9 million and €615.4 million
for the three and nine months ended September 30, 2023,
respectively.
Cost of sales were €161.8 million for the
three months ended September 30, 2023, compared to
€752.8 million for the comparative prior year period. For the
nine months ended September 30, 2023, cost of sales were
€420.7 million, compared to €2,811.5 million for the comparative
prior year period. The change was in line with decreasing COVID-19
vaccine revenues.
Research and development (R&D)
expenses were €497.9 million for the three months ended
September 30, 2023, compared to €341.8 million for the
comparative prior year period. For the nine months ended
September 30, 2023, research and development expenses were
€1,205.3 million, compared to €1,027.2 million for the
comparative prior year period. Research and Development expenses
are mainly influenced by progressing clinical studies for pipeline
candidates, the development of variant adapted as well as next
generation COVID-19 vaccines and expanding R&D headcount.
General and administrative (G&A)
expenses were €144.5 million for the three months ended
September 30, 2023, compared to €141.0 million for the
comparative prior year period. For the nine months ended
September 30, 2023, G&A expenses were €386.6 million,
compared to €361.8 million for the comparative prior year
period. G&A expenses were mainly influenced by increased
expenses for IT services as well as expanding the G&A
headcount.
Income taxes were accrued in an amount of
€66.8 million for the three months ended September 30, 2023,
compared to €659.2 million accrued for the comparative prior year
period. For the nine months ended September 30, 2023, income
taxes were accrued with an amount of €50.5 million, compared
to €2,625.8 million accrued for the comparative prior year period.
The derived annual effective income tax rate for the nine months
ended September 30, 2023, was 9.7% which is expected to change
over the 2023 financial year to be in line with the updated
estimated annual cash effective income tax rate of somewhere around
21% for the BioNTech Group.
Net profit was €160.6 million for the
three months ended September 30, 2023, compared to
€1,784.9 million for the comparative prior year period. For
the nine months ended September 30, 2023, net profit was
€472.4 million, compared to €7,155.7 million net profit for the
comparative prior year period.
Cash and cash equivalents as well as security
investments were €16,967.6 million, comprising €13,495.8
million cash and cash equivalents and €3,471.8 million
security investments, respectively, as of September 30, 2023.
Subsequent to the end of the reporting period, as of
October 16, 2023, a payment of €565.0 million was received
from BioNTech's collaboration partner, settling BioNTech’s gross
profit share for the second quarter of 2023 (as defined by the
contract with Pfizer).
Diluted earnings per share was €0.67 for
the three months ended September 30, 2023, compared to a
diluted earnings per share €6.98 for the comparative prior year
period. For the nine months ended September 30, 2023, diluted
earnings per share was €1.94, compared to €27.70 diluted earnings
per share for the comparative prior year period.
Shares outstanding as of September 30,
2023, were 237,715,500, excluding 10,836,700 shares in
treasury.
In March 2023, BioNTech initiated a new share
repurchase program pursuant to which the Company was able to
purchase American Depositary Shares, or ADSs, each representing one
ordinary share of the Company, in the amount of up to $0.5 billion
during the remainder of 2023. During the three months ended
September 30, 2023, 3,114,280 ADSs were repurchased under the share
repurchase program at an average price of €97.15 ($106.923), for
total consideration of €302.5 million ($333.1 million3).
The trading plan for BioNTech's 2023 program concluded on September
18, 2023.
“In the third quarter, we continued to invest in
our capabilities and our portfolio of innovative product candidates
while strengthening the financial position of BioNTech. About €17
billion in cash and security investments provide strategic
flexibility and is a major strength, especially in these days,
where financial stability is key,” said Jens Holstein, CFO of
BioNTech. “We updated our financial guidance for the full year
2023. In line with anticipated revenues of around €4 billion, we
reduced relevant cost drivers for 2023 as we effectively manage our
expenditures.”
Outlook updated for the 2023 Financial
YearThe Company updated its COVID-19 vaccine revenue guidance
and updates its previous expense and capex guidance for the 2023
financial year:
BioNTech COVID-19 Vaccine Revenues for the 2023
Financial Year:
|
Initial Guidance Mar 2023 |
Updated GuidanceNov 2023 |
Estimated BioNTech COVID-19 vaccine revenues for the full 2023
financial year |
~ €5 billion |
~ €4 billion |
The revenues 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. Revenue guidance is based on
various assumptions. These include, but are not limited to,
expectations regarding: transitions in the purchasing environment;
the timing and receipt of regulatory approvals and recommendations;
the progress of vaccination campaigns; and seasonal variations in
SARS-CoV-2 circulation and vaccination uptake.
Several factors drive the Company’s adjusted
revenue guidance. Such factors include BioNTech’s and Pfizer’s
lower than previously forecast revenue expectations for the full
2023 financial year, which take into account delays in the expected
timing of regulatory approvals, as well as the effects of Pfizer’s
recently-announced write-downs and other charges.
While fewer primary vaccinations and lower
population-wide levels of boosting are anticipated overall compared
to the same period in prior years, vaccine adaptation and seasonal
trends are expected to lead to demand peaks in the autumn and
winter compared to other seasons. As a result of
later-than-anticipated regulatory approvals and their effect on
national vaccination campaign timelines, expected sales have
shifted to future periods. In general, the Company continues to
remain largely dependent on revenues generated in its collaboration
partner’s territories.
In addition, BioNTech's revenues have been
affected by the inventory write-downs and other charges related to
COMIRNATY that were previously announced by the Company’s
collaboration partner Pfizer. As a result of the Company’s
continued assessment of these write-downs and other charges, the
Company has determined that the charges originating on BioNTech’s
end had largely already been reflected in the Company’s financial
results for the 2022 financial year, and to a smaller extent,
continued to be reflected during 2023. Ultimately, the initial
estimate of “up to €0.9 billion” impact has been refined by the
Company. The impact from the collaboration partner's charges onto
the Company's revenues has been identified to be €0.6 billion for
the nine months ended September 30, 2023 and €0.5 billion
for the three months ended September 30, 2023, which is
reflected in the revised revenues guidance.
Planned 2023 Financial Year Expenses and
Capex4:
|
Initial Guidance Mar 2023 |
Updated GuidanceNov 2023 |
R&D expenses5 |
€2,400m - €2,600m |
€1,800m - €2,000m |
SG&A expenses |
€650m - €750m |
€600m - €650m |
Capital expenditures for operating activities6 |
€500m - €600m |
€200m - €300m |
Estimated 2023 Financial Year Tax
Assumptions:
|
Initial Guidance Mar 2023 |
Updated GuidanceNov 2023 |
BioNTech Group estimated annual cash effective income tax
rate7 |
~ 27% |
~ 21% |
The full interim unaudited condensed
consolidated financial statements can be found in BioNTech's Report
on Form 6-K for the period ended September 30, 2023, filed today
with the United States Securities and Exchange Commission ("SEC")
and available at https://www.sec.gov/.
Endnotes
1Financial information is prepared and presented
in Euros and numbers are rounded to millions and billions of Euros
in accordance with standard commercial practice.
2BioNTech’s profit share is estimated based on
preliminary data shared between Pfizer and BioNTech as further
described in the Annual Report. Any changes in the estimated share
of the collaboration partner’s gross profit will be recognized
prospectively.
3Calculated applying the average foreign
exchange rate for the nine months ended September 30, 2023, as
published by the German Central Bank (Deutsche Bundesbank).
4Numbers reflect current base case projections
and are calculated based on constant currency rates. Excluding
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.
5Numbers include effects identified from
additional collaborations or potential M&A transactions to the
extent disclosed and will be updated as needed.
6Numbers exclude potential effects caused by or driven from
collaborations or M&A transactions.
7Numbers exclude potential effects caused by or driven from
share-based payment settlements in the course of 2023.
Operational Review and Pipeline Update for
the Third Quarter 2023 and Key Post Period-End Events
COVID-19 Vaccine Marketed Products
- In August, BioNTech and Pfizer received a positive opinion from
the European Medicines Agency (EMA) Committee for Medicinal
Products for Human Use (CHMP) recommending marketing authorization
for the companies' Omicron XBB.1.5-adapted monovalent COVID-19
vaccine for individuals 6 months of age and older.
- In September, BioNTech and Pfizer received approval of their
supplemental Biologics License Application by the U.S. Food and
Drug Administration (FDA) for their Omicron XBB.1.5-adapted
monovalent COVID-19 vaccine for individuals 12 years and older, and
emergency use authorization for individuals 6 months through 11
years of age.
- Several other national healthcare regulatory bodies, including
in the United Kingdom (UK), Japan, Canada and South Korea, have
approved BioNTech and Pfizer's monovalent XBB.1.5-adapted
vaccine.
- In October, BioNTech and Pfizer announced an agreement between
the Japanese government and Pfizer Japan Co., Ltd. to supply an
additional 9 million doses of the Omicron XBB.1.5-adapted COVID-19
vaccine for the special vaccination program in Japan which started
this autumn. This follows an agreement between the Japanese
government and Pfizer Inc. in July to supply 20 million doses and
additional supplies as needed, and an agreement announced in
September to provide additional 10 million doses of the companies’
Omicron XBB.1.5-adapted COVID-19 vaccine for the special
vaccination program in Japan.
Select Oncology Pipeline Highlights - Recent and
upcoming trial starts and data readouts
Antibody-Drug Conjugate (ADC)
Pipeline BioNTech's pipeline comprises several ADCs that are
based on a topoisomerase I inhibitor as payload.
BNT323/DB-1303 is an HER2-targeted ADC
candidate being developed in collaboration with Duality Biologics
(Suzhou) Co. Ltd. (“DualityBio”).
- An open-label, multi-center, randomized Phase 3 clinical trial
(NCT06018337) is planned to evaluate BNT323/DB-1303 versus
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 (ET) or within six months of first line ET plus CDK4/6
inhibitor in the metastatic setting, and no prior chemotherapy. The
study aims to enroll approximately 532 patients.
- In September, clinical data from the ongoing Phase 1/2 clinical
trial (NCT05150691) evaluating BNT323/DB-1303 in patients with
advanced/unresectable, recurrent, or metastatic HER2-expressing
solid tumors were presented at the 2023 European Congress on
Gynaecological Oncology Annual Meeting. BNT323/DB-1303 showed a
manageable safety profile and no new safety signals were observed.
BNT323/DB-1303 demonstrated encouraging antitumor activity in
patients (n=17) with advanced, recurrent or metastatic
HER2-expressing endometrial cancer with an objective response rate
(“ORR”; confirmed and unconfirmed) of 58.8% and disease control
rate (“DCR”) of 94.1%.
BNT324/DB-1311 is an ADC candidate being
developed in collaboration with DualityBio.
- In September, the first patient was dosed in a first-in-human,
open-label Phase 1/2 clinical trial (NCT05914116) evaluating
BNT324/DB-1311 in multiple advanced solid tumors.
BNT325/DB-1305 is a TROP-2-targeted ADC
candidate being developed in collaboration with DualityBio.
- In October, clinical data from the ongoing Phase 1/2 clinical
trial (NCT05438329) in patients with advanced solid tumors were
presented at the 2023 European Society of Medical Oncology (ESMO)
Annual Meeting suggesting a manageable safety profile at lower dose
levels. Encouraging preliminary activity of BNT325/DB-1305 was
observed with an ORR of 30.4% (7/23), and DCR of 87.0% (20/23)
(both unconfirmed) across overall study population. Encouraging
efficacy signals were observed in non-small cell lung cancer
(NSCLC) patients with an ORR of 46.2% (6/13) and an DCR of 92.3%
(12/13) (both unconfirmed).
BNT326/YL202 is a HER3-targeted ADC
candidate being developed in collaboration with MediLink
Therapeutics (Suzhou) Co., Ltd. (“MediLink”).
- A multicenter, open-label, first-in-human Phase 1 clinical
trial (NCT05653752) evaluating YL202 as a later-line treatment in
patients with locally advanced or metastatic epidermal growth
factor receptor (EGFR)-mutated NSCLC or HR-positive and
HER2-negative breast cancer is ongoing.
Next-Generation Immune Checkpoint
Immunomodulator Pipeline
BNT316/ONC-392 (gotistobart) is an
anti-CTLA-4 monoclonal antibody candidate being developed in
collaboration with OncoC4, Inc. (“OncoC4”). BNT316/ONC-392
(gotistobart) is designed to offer a differentiated safety profile
that may allow for higher dosing and longer duration of treatment
both as monotherapy and in combination with other therapies.
- In November, clinical data were presented at the 2023 Society
for Immunotherapy of Cancer (SITC) Annual Meeting from the ongoing
Phase 1/2 trial (NCT04140526) showing that BNT316/ONC-392
(gotistobart) monotherapy has a manageable safety profile. Early
readout of the expansion cohort showed encouraging clinical
activity in patients with immunotherapy-resistant NSCLC. A Phase 3
trial evaluating BNT316/ONC-392 (gotistobart) monotherapy in this
patient population is ongoing.
- A Phase 2 clinical trial (NCT05682443) is planned to evaluate
the safety and efficacy of BNT316/ONC-392 in combination with
lutetium Lu-177 vipivotide tetraxetan in metastatic castration
resistant prostate cancer patients who have disease progressed on
androgen receptor pathway inhibition.
BNT312/GEN1042 is a bispecific antibody
candidate based on Genmab A/S (“Genmab”)'s DuoBody technology and
designed to induce conditional immune activation by crosslinking
CD40 and 4-1BB positive cells.
- In November, preclinical data demonstrating in vivo antitumor
activity and peripheral immune modulation of a chimeric variant of
BNT312/GEN1042 were presented at the 2023 SITC Annual Meeting.
These data support ongoing Phase 1/2 clinical studies evaluating
the combination of BNT312/GEN1042 with pembrolizumab and
chemotherapy in patients with advanced solid tumors (NCT04083599,
NCT05491317).
BNT314/GEN1059 is a bispecific antibody
candidate designed to boost antitumor immune responses through
EpCAM-dependent 4-1BB agonistic activity. This is the fifth drug
candidate under BioNTech's collaboration with Genmab where the
development costs and potential future profits will be shared
equally.
- In October, preclinical data characterizing the mechanism of
action of BNT314/GEN1059 were presented at the 2023 ESMO Annual
Meeting.
- A first-in-human trial sponsored by BioNTech is planned to
investigate the clinical safety and preliminary antitumor activity
of BNT314/GEN1059 in patients with solid tumors.
Cancer Vaccines Pipeline
BNT116 is based on BioNTech’s FixVac
platform, and is a wholly owned, systemically administered,
off-the-shelf mRNA-based cancer vaccine candidate. This candidate
is being evaluated for the treatment of advanced NSCLC.
- In July, BioNTech and Regeneron Pharmaceuticals Inc.
(“Regeneron”) initiated a randomized, controlled Phase 2
clinical trial (NCT05557591) to evaluate BNT116 in combination with
cemiplimab (Regeneron’s Libtayo) and cemiplimab alone as first-line
treatment in patients with advanced NSCLC whose tumors express
PD-L1 in ≥ 50% of tumor cells.
- In November, clinical data from the ongoing Phase 1 clinical
trial (NCT05142189) evaluating the safety, tolerability and
preliminary efficacy of BNT116 alone and in combination with
cemiplimab (Regeneron’s Libtayo) or chemotherapy across various
cohorts of patients were presented at the 2023 SITC Annual Meeting.
BNT116 was generally well tolerated with an expected safety profile
as monotherapy and in combination with cemiplimab. In heavily
pretreated NSCLC patients, treatment with BNT116 with cemiplimab
from cycle 3 onwards showed early clinical activity.
BNT122 (Autogene cevumeran) is an
mRNA cancer vaccine candidate based on an individualized
neoantigen-specific immunotherapy (iNeST) approach being developed
in collaboration with Genentech, Inc. (“Genentech”), a member of
the Roche Group (“Roche”).
- In October, the first patient was dosed in a randomized Phase 2
clinical trial (NCT05968326) evaluating the safety and efficacy of
BNT122 in combination with atezolizumab (Roche’s Tecentriq)
followed by adjuvant standard-of-care chemotherapy (mFOLFIRINOX) in
patients with resected pancreatic ductal adenocarcinoma (PDAC)
compared to chemotherapy alone. The Phase 2 study is expected to
enroll 260 patients with resected PDAC, who have not received prior
systemic anti-cancer treatment and showed no evidence of disease
after surgery.
Cell Therapy Pipeline
BNT211 is an autologous Claudin-6
(CLDN6)-targeting chimeric antigen receptor (CAR) T cell therapy
candidate that is being tested alone and in combination with a
CAR-T cell Amplifying RNA Vaccine (“CARVac”), encoding CLDN6.
- In October, clinical data from the ongoing Phase 1/2 clinical
trial (NCT04503278) were presented at the 2023 ESMO Annual Meeting
detailing the new dose escalation of CLDN6 CAR-T cells with and
without a CLDN6-encoding mRNA vaccine for the treatment of
CLDN6-positive relapsed/refractory solid tumors using an automated
manufacturing process. CLDN6 CAR-T cells ± CLDN6 CARVac
demonstrated encouraging signs of clinical activity. In several
patients treated with CARVac, an increased persistence of
cancer-specific CAR-T cells was observed. The rate of
treatment-dependent adverse events was dose-dependent. After
determination of the recommended Phase 2 dose, BioNTech plans to
initiate a pivotal trial in germ cell tumors.
BNT221 is an autologous, fully
personalized, polyspecific T-cell therapy candidate directed
against selected sets of individual neoantigens. BNT221 is based on
expanded neoantigen-specific memory T cells and induced naive T
cells.
- In October and November, first monotherapy clinical data from
the ongoing first-in-human Phase 1 dose escalation clinical trial
(NCT04625205) in patients with checkpoint inhibitor unresponsive or
refractory metastatic melanoma were presented at the 2023 ESMO and
SITC Annual Meetings. These initial results showed a manageable
safety profile and encouraging activity signs of tumor regression
in several patients with anti-PD-1/anti-CTLA-4 pretreated advanced
or metastatic melanoma.
Select Infectious Pipeline Highlights - Recent
trial starts and data readouts
COVID-19-Influenza Combination mRNA Vaccine
Program – BNT162b2 + BNT161
- In October, BioNTech and Pfizer announced top-line results from
a Phase 1/2 clinical trial (NCT05596734) evaluating the safety,
tolerability and immunogenicity of mRNA-based combination vaccine
candidates for influenza and COVID-19 in healthy adults 18 to 64
years of age. In the clinical trial, the vaccine candidates were
compared to licensed influenza vaccines and the Pfizer-BioNTech
COVID-19 Omicron BA.4/BA.5 adapted bivalent vaccine given
separately at the same visit. The data from the trial demonstrated
robust immune responses to influenza A, influenza B, and SARS-CoV-2
strains, as well as a safety profile consistent with the safety
profile of the companies’ COVID-19 vaccine. A pivotal Phase 3 trial
is expected to be initiated in the coming months.
Mpox Program - BNT166 The BNT166 vaccine
candidates encode surface antigens that are expressed in the two
infectious forms of the mpox virus (MPXV) with the aim to
efficiently fight virus replication and infectivity. In partnership
with the Coalition for Epidemic Preparedness Innovations (CEPI),
BNT166 is part of BioNTech’s infectious disease vaccine programs
aiming to help provide equitable access to effective and
well-tolerated vaccines for high medical need indications.
- In October, the first patient was dosed in a Phase 1/2 clinical
trial (NCT05988203) evaluating the safety, tolerability,
reactogenicity and immunogenicity of two mRNA-based multivalent
vaccine candidates against mpox. The trial aims to enroll 96
healthy participants with and without prior history of known or
suspected smallpox vaccination.
Corporate Update for the Third Quarter
2023 and Key Post Period-End Events
- In July, BioNTech successfully completed its previously
announced acquisition of InstaDeep Ltd. (“InstaDeep”), following
the satisfaction of all customary closing conditions. The
acquisition supports the Company’s strategy to build world-leading
capabilities in Artificial Intelligence (“AI”)-driven drug
discovery and development. InstaDeep will operate as a UK-based
global subsidiary of BioNTech. The transaction adds approximately
290 highly skilled professionals to BioNTech’s existing
bioinformatics and data science workforce, including teams in AI,
machine learning, bioengineering, data science, and software
development.
- In September, BioNTech and CEPI announced a strategic
partnership to advance mRNA-based vaccine candidates with the
development of BNT166 for the prevention of mpox, an infectious
disease that can lead to severe, life-threatening complications.
The strategic partnership aims to contribute to CEPI’s 100 Days
Mission, a goal to accelerate development of well-tolerated and
effective vaccines against a potential future pandemic virus so
that a vaccine can be ready for regulatory authorization and
manufacturing at scale within 100 days of recognition of a pandemic
pathogen. This mission is spearheaded by CEPI and embraced by the
G7, G20, and industry leaders. The partnership between BioNTech and
CEPI could help accelerate responses to future outbreaks caused by
viruses of the Orthopoxvirus viral family. CEPI will provide
funding of up to $90 million to support the development of
mRNA-based vaccine candidates.
- Post period-end, in October, BioNTech and MediLink entered into
a strategic research collaboration and worldwide license agreement
to develop a next-generation ADC candidate against Human Epidermal
Growth Factor Receptor 3 (HER3). Under the terms of the agreement,
MediLink will grant BioNTech exclusive global rights, excluding
Mainland China, Hong Kong Special Administrative Region, and Macau
Special Administrative Region, for the development, manufacturing,
and commercialization of one of MediLink's ADC assets. In exchange,
BioNTech will provide MediLink with an upfront payment totaling of
$70 million and additional development, regulatory and commercial
milestone payments potentially totaling over $1 billion. The
completion of the agreement is subject to customary closing
conditions.
- Also, post period-end in November, BioNTech and Biotheus Inc.
(“Biotheus”), announced an exclusive license and collaboration
agreement under which BioNTech will have the rights to develop,
manufacture and commercialize PM8002, a bispecific antibody
candidate targeting PD-L1 and VEGF, globally except in Greater
China, where Biotheus retains the rights to PM8002. PM8002 is
currently being tested in a Phase 2/3 study in China to evaluate
the efficacy and safety of the candidate as a monotherapy or in
combination with chemotherapy in patients with NSCLC.
Upcoming Investor and Analyst
Events
- BioNTech’s Innovation Series Day will take place tomorrow,
Tuesday, November 7, 2023, from 9.00 a.m. ET (3.00 p.m. CET) in
Boston, USA. The event will provide an update on BioNTech’s
clinical progress across its pipeline and provide a deep dive into
scientific and technological innovations from its research engine.
The slide presentation and audio of the webcast will be available
via this link.
- BioNTech's fourth quarter and full year 2023 financial results
and corporate update are scheduled for Wednesday, March 20,
2024.
Conference Call and Webcast
Information
BioNTech invites investors and the general
public to join a conference call and webcast with investment
analysts today, November 6, 2023, at 8.00 a.m. ET (2.00 p.m. CET)
to report its financial results and provide a corporate update for
the third quarter of 2023.
To access the live conference call via
telephone, please register via this link. Once registered, dial-in
numbers and a pin number will be provided.
The slide presentation and audio of the webcast
will be available via this link.
Participants may also access the slides and the
webcast of the conference call via the “Events & Presentations”
page of the Investor Relations section of the Company’s website at
https://biontech.com. A replay of the webcast will be available
shortly after the conclusion of the call and archived on the
Company’s website for 30 days following the call.
About BioNTechBiopharmaceutical New
Technologies (BioNTech) is a next generation immunotherapy company
pioneering novel therapies for cancer and other serious diseases.
The Company exploits a wide array of computational discovery and
therapeutic drug platforms for the rapid development of novel
biopharmaceuticals. Its broad portfolio of oncology product
candidates includes individualized and off-the-shelf mRNA-based
therapies, innovative chimeric antigen receptor (CAR) T cells,
several protein-based therapeutics, including bispecific immune
checkpoint modulators, targeted cancer antibodies and antibody-drug
conjugate (ADC) therapeutics, as well as small molecules. Based on
its deep expertise in mRNA vaccine development and in-house
manufacturing capabilities, BioNTech and its collaborators are
developing multiple mRNA vaccine candidates for a range of
infectious diseases alongside its diverse oncology pipeline.
BioNTech has established a broad set of relationships with multiple
global pharmaceutical collaborators, including Duality Biologics,
Fosun Pharma, Genentech, a member of the Roche Group, Genevant,
Genmab, OncoC4, Regeneron, Sanofi and Pfizer.
For more information, please visit www.BioNTech.com.
Forward-Looking StatementsThis press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, as amended,
including, but not limited to, statements concerning: BioNTech's
expected revenues and net profit related to sales of BioNTech's
COVID-19 vaccine, referred to as COMIRNATY where approved for
use under full or conditional marketing authorization, in
territories controlled by BioNTech's collaboration partners,
particularly for those figures that are derived from preliminary
estimates provided by BioNTech's partners; the rate and degree of
market acceptance of BioNTech's COVID-19 vaccine and, if approved,
BioNTech's investigational medicines; expectations regarding
anticipated changes in COVID-19 vaccine demand, including changes
to the ordering environment and expected regulatory recommendations
to adapt vaccines to address new variants or sublineages; the
initiation, timing, progress, results, and cost of BioNTech's
research and development programs, including those relating to
additional formulations of BioNTech's COVID-19 vaccine, and
BioNTech's current and future preclinical studies and clinical
trials, including statements regarding the timing of initiation and
completion of studies or trials and related preparatory work and
the availability of results; our expectations with respect to our
intellectual property; the impact of the Company’s acquisition of
InstaDeep Ltd. and the Company's collaboration and licensing
agreements; the development of sustainable vaccine production and
supply solutions, and the nature and feasibility of these
solutions; and BioNTech's estimates of commercial and other
revenues, cost of sales, research and development expenses, sales
and marketing expenses, general and administrative expenses,
capital expenditures, income taxes, net profit, cash, cash
equivalents and security investments, shares outstanding and cash
outflows and share consideration. In some cases, forward-looking
statements can be identified by terminology such as “will,” “may,”
“should,” “expects,” “intends,” “plans,” “aims,” “anticipates,”
“believes,” “estimates,” “predicts,” “potential,” “continue,” or
the negative of these terms or other comparable terminology,
although not all forward-looking statements contain these words.
The forward-looking statements in this press release are neither
promises nor guarantees, and you should not place undue reliance on
these forward-looking statements because they involve known and
unknown risks, uncertainties, and other factors, many of which are
beyond BioNTech’s control and which could cause actual results to
differ materially from those expressed or implied by these
forward-looking statements. These risks and uncertainties include,
but are not limited to: BioNTech's pricing and coverage
negotiations with governmental authorities, private health insurers
and other third-party payors after BioNTech's initial sales to
national governments; the future commercial demand and medical
need for initial or booster doses of a COVID-19 vaccine;
competition from other COVID-19 vaccines or related to BioNTech's
other product candidates, including those with different mechanisms
of action and different manufacturing and distribution constraints,
on the basis of, among other things, efficacy, cost, convenience of
storage and distribution, breadth of approved use, side-effect
profile and durability of immune response; the timing of and
BioNTech's ability to obtain and maintain regulatory approval for
BioNTech's product candidates; the ability of BioNTech’s COVID-19
vaccines to prevent COVID-19 caused by emerging virus variants;
BioNTech's and its counterparties’ ability to manage and
source necessary energy resources; BioNTech's ability to identify
research opportunities and discover and develop investigational
medicines; the ability and willingness of BioNTech's third-party
collaborators to continue research and development activities
relating to BioNTech's development candidates and investigational
medicines; the impact of the COVID-19 pandemic on BioNTech's
development programs, supply chain, collaborators and financial
performance; unforeseen safety issues and potential claims that are
alleged to arise from the use of BioNTech's COVID-19 vaccine and
other products and product candidates developed or manufactured by
BioNTech; BioNTech's and its collaborators’ ability to
commercialize and market BioNTech's COVID-19 vaccine and, if
approved, its product candidates; BioNTech's ability to manage its
development and expansion; regulatory developments in the United
States and other countries; BioNTech's ability to effectively scale
BioNTech's production capabilities and manufacture BioNTech's
products, including BioNTech's target COVID-19 vaccine production
levels, and BioNTech's product candidates; risks relating to the
global financial system and markets; and other factors not known to
BioNTech at this time. You should review the risks and
uncertainties described under the heading “Risk Factors” in
BioNTech's Report on Form 6-K for the period ended September 30,
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
Interim Consolidated Statements of Profit or
Loss
|
Three months ended September 30, |
Nine months ended September 30, |
|
2023 |
2022 |
2023 |
2022 |
(in millions €, except per share
data) |
(unaudited) |
(unaudited) |
(unaudited) |
(unaudited) |
Revenues |
|
|
|
|
Commercial revenues |
893.7 |
3,394.8 |
2,336.6 |
12,923.3 |
Research & development revenues |
1.6 |
66.4 |
3.4 |
109.0 |
Total
revenues |
895.3 |
3,461.2 |
2,340.0 |
13,032.3 |
|
|
|
|
|
Cost of sales |
(161.8) |
(752.8) |
(420.7) |
(2,811.5) |
Research and development expenses |
(497.9) |
(341.8) |
(1,205.3) |
(1,027.2) |
Sales and marketing expenses |
(14.4) |
(12.8) |
(44.7) |
(44.9) |
General and administrative expenses |
(144.5) |
(141.0) |
(386.6) |
(361.8) |
Other operating expenses |
(31.4) |
(285.1) |
(223.7) |
(594.6) |
Other operating income |
27.8 |
459.8 |
105.2 |
1,157.5 |
Operating income |
73.1 |
2,387.5 |
164.2 |
9,349.8 |
|
|
|
|
|
Finance income |
156.3 |
60.9 |
363.2 |
448.5 |
Finance expenses |
(2.0) |
(4.3) |
(4.5) |
(16.8) |
Profit before tax |
227.4 |
2,444.1 |
522.9 |
9,781.5 |
|
|
|
|
|
Income
taxes |
(66.8) |
(659.2) |
(50.5) |
(2,625.8) |
Profit for the period |
160.6 |
1,784.9 |
472.4 |
7,155.7 |
|
|
|
|
|
Earnings per share |
|
|
|
|
Basic earnings for the period per
share |
0.67 |
7.43 |
1.96 |
29.47 |
Diluted
earnings for the period per share |
0.67 |
6.98 |
1.94 |
27.70 |
Interim Consolidated Statements of Financial
Position
|
|
September 30, |
December 31, |
(in millions
€) |
|
2023 |
2022 |
Assets |
|
(unaudited) |
|
Non-current assets |
|
|
|
Intangible assets |
|
665.5 |
158.5 |
Goodwill |
|
365.6 |
61.2 |
Property, plant and equipment |
|
728.9 |
609.2 |
Right-of-use assets |
|
197.0 |
211.9 |
Other financial assets |
|
1,292.7 |
80.2 |
Other non-financial assets |
|
0.3 |
6.5 |
Deferred
tax assets |
|
208.1 |
229.6 |
Total
non-current assets |
|
3,458.1 |
1,357.1 |
Current assets |
|
|
|
Inventories |
|
415.7 |
439.6 |
Trade and other receivables |
|
2,002.0 |
7,145.6 |
Contract assets |
|
6.8 |
— |
Other financial assets |
|
2,253.3 |
189.4 |
Other non-financial assets |
|
286.2 |
271.9 |
Income tax assets |
|
289.3 |
0.4 |
Cash and cash equivalents |
|
13,495.8 |
13,875.1 |
Total current assets |
|
18,749.1 |
21,922.0 |
Total
assets |
|
22,207.2 |
23,279.1 |
|
|
|
|
Equity
and liabilities |
|
|
|
Equity |
|
|
|
Share capital |
|
248.6 |
248.6 |
Capital reserve |
|
1,228.4 |
1,828.2 |
Treasury shares |
|
(10.8) |
(5.3) |
Retained earnings |
|
19,305.4 |
18,833.0 |
Other reserves |
|
(904.8) |
(848.9) |
Total equity |
|
19,866.8 |
20,055.6 |
Non-current liabilities |
|
|
|
Lease liabilities, loans and
borrowings |
|
161.9 |
176.2 |
Other financial liabilities |
|
38.5 |
6.1 |
Income tax liabilities |
|
— |
10.4 |
Provisions |
|
8.6 |
8.6 |
Contract liabilities |
|
268.0 |
48.4 |
Other non-financial liabilities |
|
13.1 |
17.0 |
Deferred
tax liabilities |
|
43.1 |
6.2 |
Total
non-current liabilities |
|
533.2 |
272.9 |
Current liabilities |
|
|
|
Lease liabilities, loans and
borrowings |
|
40.0 |
36.0 |
Trade payables and other payables |
|
222.7 |
204.1 |
Other financial liabilities |
|
321.6 |
785.1 |
Refund liabilities |
|
— |
24.4 |
Income tax liabilities |
|
545.2 |
595.9 |
Provisions |
|
318.0 |
367.2 |
Contract liabilities |
|
167.1 |
77.1 |
Other
non-financial liabilities |
|
192.6 |
860.8 |
Total
current liabilities |
|
1,807.2 |
2,950.6 |
Total
liabilities |
|
2,340.4 |
3,223.5 |
Total
equity and liabilities |
|
22,207.2 |
23,279.1 |
Interim Consolidated Statements of Cash
Flows
|
|
Three months ended September 30, |
Nine months ended September 30, |
|
|
2023 |
2022 |
2023 |
2022 |
(in
millions €) |
|
(unaudited) |
(unaudited) |
(unaudited) |
(unaudited) |
Operating activities |
|
|
|
|
|
Profit for the period |
|
160.6 |
1,784.9 |
472.4 |
7,155.7 |
Income
taxes |
|
66.8 |
659.2 |
50.5 |
2,625.8 |
Profit before tax |
|
227.4 |
2,444.1 |
522.9 |
9,781.5 |
Adjustments to reconcile profit before
tax to net cash flows: |
|
|
|
|
|
Depreciation and amortization of property, plant, equipment,
intangible assets and right-of-use assets |
|
41.3 |
33.5 |
104.6 |
94.3 |
Share-based payment expenses |
|
15.5 |
61.4 |
37.2 |
86.4 |
Net foreign exchange differences |
|
(20.4) |
116.2 |
(364.3) |
(222.3) |
Loss on disposal of property, plant and equipment |
|
3.3 |
0.2 |
3.6 |
0.4 |
Finance income excluding foreign exchange differences |
|
(148.5) |
(7.7) |
(357.4) |
(226.5) |
Finance expense excluding foreign exchange differences |
|
2.0 |
4.3 |
4.5 |
16.8 |
Movements in government grants |
|
— |
— |
(3.0) |
— |
Unrealized net (gain) / loss on derivative instruments at fair
value through profit or loss |
|
(3.5) |
(2.3) |
84.7 |
82.3 |
Working capital adjustments: |
|
|
|
|
|
Decrease in trade and other receivables, contract assets and other
assets |
|
631.2 |
2,245.4 |
6,648.6 |
5,016.7 |
Decrease in inventories |
|
33.2 |
72.9 |
23.9 |
207.7 |
(Decrease) / increase in trade payables, other financial
liabilities, other liabilities, contract liabilities, refund
liabilities and provisions |
|
(25.0) |
565.9 |
(293.9) |
760.3 |
Interest received |
|
70.3 |
4.3 |
166.4 |
6.5 |
Interest paid |
|
(1.2) |
(4.3) |
(3.7) |
(16.5) |
Income tax paid |
|
(10.2) |
(753.3) |
(1,292.4) |
(2,834.7) |
Share-based payments |
|
(4.2) |
(1.7) |
(761.2) |
(4.7) |
Net
cash flows from operating activities |
|
811.2 |
4,778.9 |
4,520.5 |
12,748.2 |
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
Purchase of property, plant and
equipment |
|
(53.2) |
(77.9) |
(165.6) |
(192.6) |
Proceeds from sale of property, plant
and equipment |
|
(0.8) |
0.4 |
(0.8) |
0.4 |
Purchase of intangible assets and
right-of-use assets |
|
(97.2) |
(4.7) |
(348.9) |
(26.2) |
Acquisition of subsidiaries and
businesses, net of cash acquired |
|
(336.9) |
— |
(336.9) |
— |
Investment in other financial
assets |
|
(744.1) |
(1.1) |
(3,407.2) |
(31.1) |
Proceeds from maturity of other financial assets |
|
— |
— |
— |
375.2 |
Net
cash flows from / (used in) investing activities |
|
(1,232.2) |
(83.3) |
(4,259.4) |
125.7 |
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
Proceeds from issuance of share capital
and treasury shares, net of costs |
|
— |
— |
— |
110.5 |
Proceeds from loans and borrowings |
|
0.1 |
0.4 |
0.1 |
0.6 |
Repayment of loans and borrowings |
|
(0.1) |
— |
(0.1) |
(18.8) |
Payments related to lease
liabilities |
|
(9.3) |
(10.0) |
(28.0) |
(31.9) |
Share repurchase program |
|
(301.7) |
(643.8) |
(737.7) |
(930.7) |
Dividends |
|
— |
— |
— |
(484.3) |
Net
cash flows used in financing activities |
|
(311.0) |
(653.4) |
(765.7) |
(1,354.6) |
|
|
|
|
|
|
Net increase / (decrease) in cash and
cash equivalents |
|
(732.0) |
4,042.2 |
(504.6) |
11,519.3 |
Change in cash and cash equivalents
resulting from exchange rate differences and other valuation
effects |
|
61.2 |
46.7 |
125.3 |
211.7 |
Cash
and cash equivalents at the beginning of the period |
|
14,166.6 |
9,334.8 |
13,875.1 |
1,692.7 |
Cash and cash equivalents as of September 30 |
|
13,495.8 |
13,423.7 |
13,495.8 |
13,423.7 |
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