- BioNTech and Pfizer continue to
build on global COVID-19 vaccine leadership with first-to-market
Original/Omicron BA.4/BA.5-adapted bivalent vaccine launches across
multiple countries and regions worldwide
- Approximately 300 million doses of
the Original/Omicron BA.1- and BA.4/BA.5-adapted bivalent vaccines
invoiced as of mid-October 2022
- In infectious diseases, Phase 1
trial initiated with a combination vaccine candidate, incorporating
the Pfizer-BioNTech Omicron BA.4/BA.5-adapted bivalent COVID-19
vaccine and Pfizer’s quadrivalent modified RNA (modRNA) influenza
vaccine candidate, both based on BioNTech’s proprietary mRNA
platform
- Continued oncology pipeline
expansion with three new first-in-human trial starts for BNT116,
BNT142, and BNT313
- Presented positive follow-up data
from the Phase 1/2 trial evaluating the Company’s novel CAR-T cell
therapy candidate, BNT211, in patients with relapsed or refractory
solid tumors at ESMO 2022
- For the nine months ended September
30, 2022, revenues of €13.0 billion1 (9M 2021: €13.4 billion1), net
profit of €7.2 billion (9M 2021: €7.1 billion) and fully diluted
earnings per share of €27.70 or $29.472 (9M 2021: €27.46 or
$32.852)
- Strong liquidity of €13.4 billion
cash and cash equivalents plus total trade receivables of €7.3
billion outstanding as of September 30, 2022; €3.2 billion of the
€7.3 billion trade receivables were received in cash as of October
15, 2022
- BioNTech raises the lower end of
its 2022 full year financial guidance to include estimated COVID-19
vaccine revenue of €16 - 17 billion
Conference call and webcast scheduled for
November 7, 2022, at 8:00 am ET (2:00 pm CET)
MAINZ, Germany, November 7, 2022 (GLOBE
NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or the
"Company”) today reported financial results for the three and nine
months ended September 30, 2022 and provided an update on its
corporate progress.
“I would like to thank our growing BioNTech team
for their outstanding performance in the first nine months of 2022
which allowed us to be the first Company to provide access to a
BA.4/BA.5 variant adapted bivalent vaccine at an unprecedented
speed. We are working to leverage this experience and apply the
lessons learned from the development of Omicron-adapted vaccines to
other disease areas and product candidates,” said Prof.
Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “The
next chapter of BioNTech’s evolution is becoming tangible; we
continue to expand our COVID-19 vaccine and infectious disease
portfolio and advance our oncology pipeline. We reaffirm our
commitment to improving the health of people worldwide by
developing immunotherapies that utilize the full potential of the
immune system to fight cancer, infectious and other serious
diseases.”
Financial Review for the Third Quarter
and First Nine Months of 2022
in millions, except per share data |
Third Quarter 2022 |
Third Quarter 2021 |
First Nine Months 2022 |
First Nine Months 2021 |
Total Revenues1 |
€3,461.2 |
€6,087.3 |
€13,032.3 |
€13,444.2 |
Net Profit |
€1,784.9 |
€3,211.0 |
€7,155.7 |
€7,126.3 |
Diluted Earnings per Share |
€6.98 |
€12.35 |
€27.70 |
€27.46 |
Total revenues reported were
€3,461.2 million1 for the three months ended September 30, 2022 (Q3
2021: €6,087.3 million1). As expected, the course of the pandemic
remains dynamic and led to fluctuations in quarterly revenues. For
the nine months ended September 30, 2022, total revenues were
€13,032.3 million1 (9M 2021: €13,444.2 million1).
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 September 30, 2022, BioNTech’s
commercial revenues included €2,554.2 million1 gross profit share
(Q3 2021: €4,358.5 million1). For the nine months ended September
30, 2022, BioNTech's commercial revenues included €9,128.4 million1
gross profit share (9M 2021: €10,202.7 million1). 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 nine months ended September
30, 2022, BioNTech recognized €564.5 million and €2,284.6 million
of direct COVID-19 vaccine sales to customers in BioNTech’s
territory, Germany and Turkey, as well as €259.4 million and
€1,470.9 million from sales of products manufactured by BioNTech
for its collaboration partners. During the comparative prior year
periods, €1,350.8 million and €2,586.2 million were recognized from
sales to customers in BioNTech’s territory as well as €312.3
million and €514.3 million from sales of products manufactured by
BioNTech for its collaboration partners respectively.
Cost of sales were €752.8
million for the three months ended September 30, 2022 (Q3 2021:
€1,211.4 million). For the nine months ended September 30, 2022,
cost of sales were €2,811.5 million (9M 2021: €2,328.3 million).
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 the Company’s
collaboration partner Pfizer. In addition, cost of sales were
impacted by expenses arising from inventory write-offs and expenses
for production capacities derived from contracts with contract
manufacturing organizations.
Research and development
expenses were €341.8 million for the three months ended
September 30, 2022 (Q3 2021: €260.4 million). For the nine months
ended September 30, 2022, research and development expenses were
€1,027.2 million (9M 2021: €677.7 million). The increase was mainly
due to increased headcount and higher expenses in the context of
the share-based payments.
General and administrative
expenses were €141.0 million for the three months ended
September 30, 2022 (Q3 2021: €68.2 million). For the nine months
ended September 30, 2022, general and administrative expenses were
€361.8 million (9M 2021: €154.9 million), mainly due to recognizing
increased expenses for purchased external services as well as an
increase in headcount.
Income taxes were accrued with
an amount of €659.2 million for the three months ended September
30, 2022 (Q3 2021: €1,456.4 million). For the nine months ended
September 30, 2022, income taxes were accrued in an amount of
€2,625.8 million (9M 2021: €3,206.2 million). The derived effective
income tax rate for the nine months ended September 30, 2022 was
26.8%.
Net profit was €1,784.9 million
for the three months ended September 30, 2022 (Q3 2021: €3,211.0
million). For the nine months ended September 30, 2022, net profit
was €7,155.7 million (9M 2021: €7,126.3 million).
As of September 30, 2022, cash and cash
equivalents were €13,423.7 million. Trade receivables
remained outstanding as of September 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 second quarter
of 2022 (as defined by the contract) for which the settlement
payment was received subsequent to the end of the reporting period
in October 2022. Of the total trade receivables of
€7,309.4 million which were outstanding as of September 30,
2022, €3,185.9 million were received in cash as of October 15,
2022.
“Thanks to our strong execution in the third
quarter of 2022, we updated our COVID-19 vaccine revenue guidance
for the year 2022 to the upper end of the original range. We
started shipments of our Omicron-adapted bivalent vaccines early in
September and we expect to carry on with our deliveries throughout
the fourth quarter of 2022,” said Jens Holstein,
CFO of BioNTech. “We believe in the potential of
our COVID-19 franchise and plan to build on our leading position
with ongoing innovations in this field. The power of our scientific
innovation combined with our strong financial position allows us to
accelerate and expand our diversified clinical pipeline and to
create future growth in the interest of all stakeholders.”
Updated Outlook for the
2022 Financial Year:
Raised COVID-19 vaccine
revenue target to upper end of original guidance. Reiterate planned
expenses and capex. Updated the estimated annual effective income
tax rate.
The Company’s outlook 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 |
€16 billion - €17 billion (previously €13 billion - €17
billion) |
BioNTech updates its 2022 financial guidance,
raising its COVID-19 vaccine revenue estimate to the upper end of
the original range: €16 - 17 billion (previously: €13 - 17
billion). The updated guidance reflects the shipment of the
Omicron-adapted bivalent vaccine boosters, which started early in
September and is expected to continue throughout the fourth quarter
of 2022 as well as higher prices and a positive foreign currency
effect.
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. BioNTech’s COVID-19 vaccine
gross profit share from Pfizer is impacted by inventory write-offs.
Pfizer inventory write-offs for COVID-19 products reduce BioNTech’s
gross profit share and therefore, reduce BioNTech’s vaccine
revenues.
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 |
~27% (previously ~28%) |
Operational Review of the Third Quarter
2022 and Key Post Period-End Events
COVID-19 Vaccine Programs –
BNT162 (COMIRNATY)
BioNTech and Pfizer continue to build on their
global COVID-19 vaccine leadership with first-to-market
Original/Omicron BA.4/BA.5-adapted vaccine launches. The Companies
have now three commercial stage COVID-19 vaccine products on the
market that include the original COVID-19 vaccine and two Omicron
adapted vaccines: Original/BA.1- and BA.4/5.-adapted bivalent
vaccines. BioNTech’s flexible mRNA platform and production
infrastructure supported rapid development and manufacturing of
variant-adapted vaccines at an unprecedented speed. BioNTech will
continue to innovate to advance a diverse pipeline of follow-on and
next generation product candidates. BioNTech believes its COVID-19
vaccine franchise will remain a long-term sustainable business
opportunity.
Commercial updates
Following regulatory approvals, BioNTech and
Pfizer immediately began shipping Original/Omicron BA.1 and
BA.4/BA.5-adapted bivalent COVID-19 vaccines in September 2022 in
time for fall and winter booster campaigns. Shipments in the United
States began approximately two months after the U.S. Food and Drug
Administration (FDA) provided its guidance for the
BA.4/BA.5-adapted bivalent COVID-19 vaccine.
As of mid-October 2022, BioNTech and Pfizer have
invoiced approximately 300 million doses of
Original/Omicron-adapted bivalent vaccine.
As part of BioNTech and Pfizer's
2-billion-doses-pledge to support equitable access to medicines,
the companies have delivered approximately 1.6 billion doses of the
companies’ COVID-19 vaccine in total to low- and middle-income
countries in line with the demand.
BioNTech expects to invoice up to 2.1 billion
doses of the COVID-19 vaccine in 2022. Some dose deliveries have
been shifted into 2023 due to the evolving dynamics of demand.
BioNTech believes that it and Pfizer are well
positioned to supply the quantities required by global market
demand.
Clinical development and regulatory updates
During the third quarter of 2022, BioNTech and
Pfizer’s COVID-19 vaccine received multiple regulatory approvals
and authorizations, including for Omicron-adapted bivalent
vaccines, label expansions for pediatric vaccinations and ongoing
conversions from conditional or emergency approvals to full
regulatory approvals across various regions worldwide. The
companies’ Original/Omicron BA.4/BA.5-adapted bivalent vaccine has
received approvals in more than 45 countries and regions, as of
October 25, 2022.
Adapted bivalent vaccine
boosters
- In August 2022, BioNTech and Pfizer started a randomized Phase
2/3 trial evaluating the safety, tolerability and immunogenicity of
the Original/Omicron BA.4/BA.5-adapted bivalent vaccine in
individuals aged 12 years and older. First data from this trial
were reported in October 2022. A 30-µg booster dose of the vaccine
demonstrated a substantial increase in the Original/Omicron
BA.4/BA.5 neutralizing antibody response above pre-booster levels
based on sera taken seven days after administration, with similar
responses seen across individuals aged 18 to 55 years and those
older than 55 years of age (40 participants in each age group). The
Omicron BA.4/BA.5-adapted bivalent vaccine was well tolerated with
early data indicating a favorable safety profile, similar to that
of the original vaccine.
- On August 31, 2022, BioNTech and Pfizer received U.S. FDA
Emergency Use Authorization (EUA) for a 30-µg booster dose of the
Original/Omicron BA.4/BA.5-adapted bivalent vaccine for individuals
aged 12 years and older.
- On September 1, 2022, BioNTech and Pfizer received a positive
European Medicines Agency (EMA) Committee for Medicinal Products
for Human Use (CHMP) opinion and subsequent EC approval for the
Original/Omicron BA.1-adapted bivalent vaccine and on September 12,
2022 for a 30-µg booster dose of the Original/Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals aged 12
years and older.
- In September 2022, BioNTech and Pfizer initiated a Phase 1/2/3
study to evaluate the safety, tolerability and immunogenicity of
different doses and dosing regimens of the Original/Omicron
BA.4/BA.5-adapted bivalent vaccine in children 6 months through 11
years of age. This pediatric study follows a previous Phase 1/2/3
trial in these age groups that demonstrated the original vaccine is
well-tolerated and offers a high level of protection against
COVID-19.
- In September 2022, BioNTech and Pfizer submitted a request to
the U.S. FDA for EUA for Original/Omicron BA.4/BA.5-adapted
bivalent vaccine booster and also completed a submission for
conditional Marketing Authorization (cMA) in the European Union for
children 5 through 11 years of age.
- In October 2022, the companies received U.S. FDA EUA for a
10-µg booster dose of the Original/Omicron BA.4/BA.5-adapted
bivalent vaccine in children 5 through 11 years of age.
- The Centers for Disease Control and Prevention has added
COVID-19 vaccines to the agency's lists of recommended regular
immunizations and recommends that people ages 5 years and older
receive one updated bivalent booster if it has been at least 2
months since their last COVID-19 vaccine dose.
- In November 2022, BioNTech and Pfizer reported updated 30-day
clinical data from the randomized Phase 2/3 trial evaluating the
safety, tolerability and immunogenicity of the companies’
Original/Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, given
as a 30-µg booster dose, which started in August 2022. The data
demonstrate a robust and broadly neutralizing immune response one
month after a 30-µg booster dose. Immune responses were markedly
higher for those who received the bivalent vaccine compared to the
original COVID-19 vaccine, with similar favorable safety and
tolerability profile demonstrated between both vaccines. Clinical
data demonstrated that Omicron BA.4/BA.5-neutralizing antibody
titers rose 13.2-fold from pre-booster levels in adults over 55
years and 9.5-fold for adults 18 to 55 years, one month post
bivalent booster compared to 2.9-fold rise in titers elicited in
the same time frame by the original vaccine booster. These results
reinforce the early clinical data measured seven days after a
booster dose of the bivalent vaccine, as well as the pre-clinical
data, and suggest that a 30-µg booster dose of the Original/Omicron
BA.4/BA.5 bivalent vaccine may induce higher level of protection
against the Omicron BA.4 and BA.5 subvariants than the original
vaccine. BioNTech and Pfizer have shared these data with the U.S.
FDA and plan to share with the EMA and other global health
authorities as soon as possible.
Original COVID-19 vaccine
- In August 2022, BioNTech and Pfizer announced updated efficacy
data from a Phase 2/3 trial evaluating a 3-μg dose series of the
original COVID-19 vaccine in children 6 months through 4 years of
age. Vaccine efficacy, a secondary endpoint in the trial, was 73.2%
in children without evidence of prior COVID-19 infection, during a
period of circulating Omicron BA.2. The vaccine previously received
EUA from the U.S. FDA and the companies submitted for extension of
the cMA in the European Union for this age group.
- In September 2022, BioNTech and Pfizer were granted approval in
the European Union for COMIRNATY as a 10-µg booster (third) dose of
the original vaccine given at least six months after completion of
a primary series for children 5 through 11 years of age.
- In October 2022, BioNTech and Pfizer received EC approval for
the conversion of the cMA to full Marketing Authorization (MA). The
conversion applies to all existing and upcoming indications and
formulations of the COMIRNATY product group authorized in the
European Union, including Original/BA.1 and BA.4/BA.5-adapted
bivalent vaccines as booster doses for individuals aged 12 years
and older.
- In October 2022, BioNTech and Pfizer received EC approval for
full MA for a 3-µg dose of COMIRNATY as a three-dose series for
children aged 6 months through 4 years.
- In October 2022, BioNTech and Pfizer received EC approval for a
fourth dose booster of COMIRNATY in individuals 12 years of age and
older at an interval of at least three months between the
administration of COMIRNATY and the last prior dose of a COVID-19
vaccine.
The COVID-19 vaccine continues to offer
protection post booster vaccination against severe disease,
hospitalization and deaths for circulating Omicron sublineages.
BioNTech and Pfizer continue to monitor
protection offered by the original and Original/Omicron adapted
bivalent vaccines against emerging SARS-CoV-2 variants.
Recently published data (Muik et al. Exposure to
BA.4/BA.5 Spike glycoprotein drives pan-Omicron neutralization in
vaccine-experienced humans and mice; bioRxiv 2022.09.21.508818)
suggest that when administered as boosters, mono- and bivalent
Original/Omicron BA.4/BA.5-adapted vaccines may enhance
neutralization breadth against Omicron sublineages BA.1, BA.2,
BA.2.12.1, and BA.4/BA.5. The preclinical data support the
assumption that boosting with an Original/Omicron BA.4/5-adapted
bivalent vaccine is a suitable strategy to confer a broader
neutralization and address both currently circulating Omicron
variants as well as potential future emerging Omicron sublineages
or new variants of concern that are closer to the wild-type
strain.
Next generation COVID-19
vaccine
In addition to variant adapted vaccines,
BioNTech and Pfizer are identifying and investigating novel next
generation vaccine approaches to maintain a broad and longer
lasting immune response and high levels of protection against
COVID-19 as SARS-CoV-2 evolves. The long-term strategy takes a
multipronged approach devised to develop multiple engineered
vaccine candidates with the aim of delivering a pan-SARS-CoV-2-type
vaccine that will help to better manage future variants of concern.
The companies expect that scientific data derived from those
different approaches will support the selection of the vaccine
candidate 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.
- In July 2022, BioNTech and Pfizer started a Phase 2 study with
a first enhanced spike antigen vaccine candidate.
- The first T cell enhancing SARS-CoV-2 vaccine product
candidate (BNT164b4) in combination with the Original/Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine is expected to enter
the clinic in the fourth quarter of 2022.
COVID-19 – Influenza Combination mRNA Vaccine
Program (BNT162b2 + BNT161)In October 2022, BioNTech and Pfizer
initiated a Phase 1 open-label, dose-finding study to evaluate the
safety, tolerability and immunogenicity of a combination of the
COVID-19 and influenza mRNA vaccines to help protect individuals
against two severe respiratory viral diseases. The combination
vaccine consists of Original/Omicron BA.4/BA.5-adapted bivalent
COVID-19 vaccine and quadrivalent modRNA influenza vaccine
candidate and will be tested at different dose levels in
approximately 180 healthy adults 18 to 64 years of age. The
companies are building on the experiences made in the BNT161
program, which pursues development of an influenza vaccine based on
BioNTech's suite of mRNA platforms.
Influenza Vaccine Program
(BNT161)
BNT161 - BioNTech is
collaborating with Pfizer to develop an influenza vaccine based on
BioNTech's suite of mRNA platforms.
- In July 2022, positive immunogenicity data from the Phase 2
expansion study of BNT161 were reported.
- In September 2022, Pfizer announced that the first participants
have been dosed in a pivotal Phase 3 clinical trial to evaluate the
efficacy, safety, tolerability and immunogenicity of a quadrivalent
modRNA influenza vaccine candidate in approximately 25,000 healthy
U.S. adults. Upon potential approval and commercialization,
BioNTech is eligible to receive milestone payments and a royalty on
Pfizer’s worldwide sales.
Shingles Vaccine Program
BioNTech is collaborating with Pfizer to develop
the first mRNA-based shingles vaccine candidate. A clinical trial
is expected to start in the fourth quarter of 2022.
Further Infectious Disease
Programs
BioNTech is applying its validated mRNA vaccine
platform across multiple high-need infectious diseases.
BioNTech is on track to initiate a
first-in-human clinical trial in the fourth quarter of 2022 for
mRNA-based product candidate BNT163, designed to address herpes
simplex virus type 2 (HSV 2). A first-in-human clinical trial of an
mRNA vaccine to protect against malaria (BNT165) is expected to
start in the fourth quarter of 2022 or early 2023. A first-in-human
clinical trial of an mRNA vaccine to protect against tuberculosis
(BNT164) is expected to start early 2023.
In 2023, BioNTech expects to start up to five
vaccine clinical trials in infectious diseases.
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. These drug classes 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 19 product candidates in 24 ongoing clinical
trials including five 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).
In the third quarter of 2022, BioNTech started
three first-in-human clinical trials: BNT116, a FixVac program for
non-small cell lung cancer (NSCLC), BNT142, a bispecific RiboMab
targeting CD3 on T cells and Claudin-6 (CLDN6) in solid tumors and,
most recently, BNT313, a HexaBody targeting CD27, a new product
candidate from BioNTech’s collaboration with Genmab A/S being
evaluated in solid tumors.
BioNTech expects continued pipeline advancement
and expansion as well as one more data readout from an ongoing
trial for the remainder of 2022. In 2023, BioNTech expects to
provide up to ten clinical trial updates in
oncology.
Third Quarter 2022 Clinical Oncology
Pipeline Update
BNT116, BioNTech’s FixVac
product candidate for the treatment of advanced or metastatic
non-small cell lung cancer (NSCLC), encodes for six
tumor-associated antigens that cover up to 100% of patients in all
major histologic subtypes of NSCLC and aims to elicit a
tumor-antigen-specific immune response. FixVac is an off-the-shelf
cancer immunotherapy approach based on BioNTech’s uridine mRNA
lipoplex technology targeting shared non-mutated
antigens.
- 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 with
cemiplimab (anti-PD-1, Regeneron's Libtayo) in patients with
advanced or metastasized NSCLC. The trial is intended to establish
a safe dose for BNT116 monotherapy as well as for BNT116 in
combination with cemiplimab 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.
- A second trial evaluates BNT116 alone and in combination with
cemiplimab as first-line treatment of patients with advanced NSCLC
whose tumors express programmed cell death ligand-1 (PD-L1) in ≥
50% of tumor cells. The primary objective of the Phase 1/2 trial is
to assess the safety and tolerability as well as the overall
response rate (ORR) and tumor burden reduction. The trial is
expected to dose the first patient in the fourth quarter of 2022
and is sponsored by Regeneron Pharmaceuticals, Inc.
BNT142, BioNTech’s second
RiboMab product candidate, is an mRNA that 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.
- In July 2022, the first patient 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.
BNT211 is a CAR directing T
cells against the novel target CLDN6 that is tested alone and in
combination with a CAR-T cell-amplifying RNA vaccine, or CARVac,
encoding CLDN6. CARVac drives in vivo expansion of transferred
CAR-T cells, aiming to increase their persistence and efficacy.
BNT211 aims to overcome CAR-T cell therapy limitations in patients
with solid tumors.
- In September 2022, BioNTech presented follow-up data from its
ongoing Phase 1/2 trial evaluating the safety and preliminary
efficacy of BNT211 in patients with relapsed or refractory solid
tumors at the European Society for Medical Oncology (ESMO) Congress
2022. Signs of anti-tumor activity were observed and the safety
profile remained manageable for the two tested dose levels.
Efficacy assessment of the 21 evaluable patients showed a best ORR
of 33% and a DCR of 67% with one complete response, six partial
responses and seven patients with stable disease. In line with the
earlier data presented, encouraging clinical responses were seen in
patients with testicular cancer treated with dose level 2 after
lymphodepletion (n=7), where one complete response, three partial
responses and two stable diseases were observed, representing an
ORR of 57% and a disease control rate (DCR) of 85%.
BNT312/GEN1042, is a
first-in-class bispecific antibody designed to induce conditional
immune activation by crosslinking CD40 and 4-1BB positive cells.
BNT312 is partnered with Genmab as part of a 50/50 collaboration in
which development costs and future profit are shared.
- A Phase 1/2 trial in patients with solid tumors is ongoing.
Expansion cohorts in melanoma, NSCLC, pancreatic and head and neck
carcinoma are recruiting for combination regimens of BNT312 in
these indications. Safety and preliminary efficacy data of BNT312
combination therapy in patients with advanced solid tumors are
planned to be presented at the ESMO-Immuno-Oncology annual congress
in December 2022.
BNT313/GEN1053
is a monospecific antibody candidate targeting CD27 to address
malignant solid tumors. It is based on Genmab's HexaBody technology
and is engineered to induce clustering of CD27 on the plasma
membrane of T cells with the aim to enhance T cell activation,
proliferation and differentiation without depleting T cells. BNT313
is partnered with Genmab as part of a 50/50 collaboration in which
development costs and potential future profits for BNT313 will be
shared equally.
- In November 2022, a Phase 1 trial was initiated to evaluate the
safety, tolerability and preliminary efficacy of BNT313 as a
monotherapy for the treatment of malignant solid tumors. The dose
escalation part will explore the safety of escalating doses of
BNT313. The expansion part is planned to provide additional safety
and initial antitumor activity information on the selected dose
regimen in selected tumor indications, as well as more detailed
data related to the mode of action.
- At the 37th Annual Meeting of the Society for Immunotherapy of
Cancer (SITC) in November 2022, BioNTech intends to present
preclinical data that characterize the mechanism of action of
HexaBody-CD27. In the in vitro experiments, HexaBody-CD27 exhibited
CD27 agonist activity independently of Fc gamma receptor-mediated
crosslinking. HexaBody-CD27 enhanced activation, proliferation, and
proinflammatory cytokine secretion of human CD4+ and CD8+ T cells
as well as CD8+ T -cell mediated cytotoxic activity towards tumor
cells in vitro. In mice expressing human CD27 protein, it enhanced
expansion and IFN-γ secretion of antigen-specific CD8+ T cells in
vivo. Overall, the data demonstrated a unique potential mechanism
of action that distinguishes HexaBody-CD27 from benchmark
monoclonal antibodies targeting CD27.
Corporate Updates
- BioNTech continues to facilitate equitable access to its
medicines. As part of this commitment, construction of BioNTech’s
first Africa-based mRNA vaccine manufacturing facility in Kigali,
Rwanda is progressing with the first BioNTainer being ready for
shipment by the end of 2022. The facility is planned to be able to
manufacture a range of mRNA-based vaccines targeted to the needs of
the African Union member states, such as the COVID-19 vaccine and
investigational malaria and tuberculosis vaccine candidates pending
authorization by respective regulatory authorities. Implementation
of a Rwandan manufacturing team is also advancing with first senior
team members already onboarded.
- In October 2022, BioNTech signed a Letter of Intent with the
State of Victoria in Australia for a strategic partnership to
collaborate on the research and development of potential mRNA-based
vaccines and therapies. The parties will establish a research and
innovation center in Melbourne where BioNTech plans to set up a
clinical scale end-to-end mRNA manufacturing facility based on its
BioNTainer solution to support the design, manufacture and clinical
testing of product candidates.
- BioNTech values and respects valid and enforceable intellectual
property rights of others and remains confident in its intellectual
property. During the course of the third quarter of 2022, CureVac
AG and ModernaTX, Inc. filed patent infringement lawsuits against
BioNTech and its partner, Pfizer. BioNTech is evaluating these
lawsuits and intends to determine the appropriate action in
response to these lawsuits.
- BioNTech continues to monitor the
natural gas supply situation as part of its regular business
continuity management and continues to evaluate possible additional
energy supply measures. BioNTech has evaluated its ongoing
mitigation efforts to ensure business continuity in light of
potential energy supply issues in Europe and elsewhere.BioNTech’s
manufacturing supply chain remains stable, and the Company does not
anticipate energy-related disruptions. BioNTech’s commercial
production of its COVID-19 vaccine continues to 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 continue to be dependent on gas, and the Company is
putting measures in place to mitigate related risks. BioNTech
continues to evaluate the impact to its partners, including Pfizer,
suppliers and other service providers.
- The first tranche of BioNTech’s
share repurchase program of ADSs, with a value of up to $1.0
billion, was executed from May 2, 2022 to October 10, 2022. In the
first tranche of the share repurchase program, BioNTech repurchased
6,945,513 ADSs at an average price of $143.98. In November 2022,
BioNTech’s Management Board and Supervisory Board authorized the
second tranche of the Company’s share repurchase program of ADSs,
with a value of up to $0.5 billion, commencing on December 7,
2022.
The full unaudited interim 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/.
Endnotes 1 BioNTech'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 nine months ended
September 30, 2022, filed as an exhibit to BioNTech’s Current
Report on Form 6-K filed on November 7, 2022. Any changes in the
estimated share of the collaboration partner's gross profit will be
recognized prospectively.2 Calculated applying the average
foreign exchange rates for the three and nine months ended
September 30, 2021 and 2022, respectively, as published by the
German Central Bank (Deutsche Bundesbank).
Conference Call and Webcast
Information
BioNTech invites investors and the general
public to join a conference call and webcast with investment
analysts on November 7, 2022 at 8.00 a.m. EDT (2.00 p.m. CEST) to
report its financial results and provide a corporate update for the
third 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. 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.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; 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 BioNTech’s COVID-19 vaccine to prevent
COVID-19 caused by emerging virus variants; BioNTech's and its
counterparties’ ability to manage and source necessary energy
resources; BioNTech's ability to identify research opportunities
and discover and develop investigational medicines; the ability and
willingness of BioNTech's third-party collaborators to continue
research and development activities relating to BioNTech's
development candidates and investigational medicines; the impact of
the COVID-19 pandemic on BioNTech's development programs, supply
chain, collaborators and financial performance; unforeseen safety
issues and claims for potential personal injury or death arising
from the use of BioNTech's COVID-19 vaccine and other products and
product candidates developed or manufactured by BioNTech;
BioNTech's 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 research and development
revenues, commercial revenues, cost of sales, research and
development expenses, sales and marketing expenses, general and
administrative expenses, capital expenditures, income taxes, and
shares outstanding; 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 three and nine months ended September 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.
CONTACTSInvestor
Relations Sylke Maas, Ph.D. VP Investor Relations &
Strategy Tel: +49 (0)6131 9084 1074
E-mail: Investors@biontech.de
Media Relations Jasmina Alatovic VP Corporate
Communications Tel: +49 (0)6131 9084 1513
E-mail: Media@biontech.de
Interim Condensed Consolidated Statements
of Profit or Loss
|
Three months ended September
30, |
Nine months ended September
30, |
|
2022 |
2021 |
2022 |
2021 |
(in
millions, except per share data) |
(unaudited) |
(unaudited) |
(unaudited) |
(unaudited) |
|
|
|
|
|
Revenues |
|
|
|
|
Commercial revenues |
€3,394.8 |
€6,040.1 |
€12,923.3 |
€13,348.1 |
Research
& development revenues |
66.4 |
47.2 |
109.0 |
96.1 |
Total revenues |
€3,461.2 |
€6,087.3 |
€13,032.3 |
€13,444.2 |
|
|
|
|
|
Cost of sales |
(752.8) |
(1,211.4) |
(2,811.5) |
(2,328.3) |
Research and development expenses |
(341.8) |
(260.4) |
(1,027.2) |
(677.7) |
Sales and marketing expenses |
(12.8) |
(10.5) |
(44.9) |
(32.5) |
General and administrative expenses |
(141.0) |
(68.2) |
(361.8) |
(154.9) |
Other operating expenses |
(285.1) |
(26.4) |
(594.6) |
(27.3) |
Other operating income |
459.8 |
213.1 |
1,157.5 |
360.6 |
Operating income |
€2,387.5 |
€4,723.5 |
€9,349.8 |
€10,584.1 |
|
|
|
|
|
Finance income |
60.9 |
26.6 |
448.5 |
51.4 |
Finance expenses |
(4.3) |
(82.7) |
(16.8) |
(303.0) |
Profit before tax |
€2,444.1 |
€4,667.4 |
€9,781.5 |
€10,332.5 |
|
|
|
|
|
Income
taxes |
(659.2) |
(1,456.4) |
(2,625.8) |
(3,206.2) |
Profit for the
period |
€1,784.9 |
€3,211.0 |
€7,155.7 |
€7,126.3 |
|
|
|
|
|
Earnings per share |
|
|
|
|
Basic profit for the period per share |
€7.43 |
€13.14 |
€29.47 |
€29.22 |
Diluted
profit for the period per share |
€6.98 |
€12.35 |
€27.70 |
€27.46 |
Interim Condensed Consolidated Statements
of Financial Position
|
September 30, |
December 31, |
(in
millions) |
2022 |
2021 |
Assets |
(unaudited) |
|
Non-current assets |
|
|
Intangible assets |
€226.2 |
€202.4 |
Property, plant and equipment |
488.5 |
322.5 |
Right-of-use assets |
272.0 |
197.9 |
Other financial assets |
52.8 |
21.3 |
Other assets |
1.1 |
0.8 |
Deferred expenses |
7.5 |
13.6 |
Deferred
tax assets |
343.7 |
— |
Total non-current assets |
€1,391.8 |
€758.5 |
Current assets |
|
|
Inventories |
294.8 |
502.5 |
Trade and other receivables |
7,309.4 |
12,381.7 |
Other financial assets |
4.8 |
381.6 |
Other assets |
162.7 |
64.9 |
Income tax assets |
0.4 |
0.4 |
Deferred expenses |
73.0 |
48.5 |
Cash and cash equivalents |
13,423.7 |
1,692.7 |
Total current assets |
€21,268.8 |
€15,072.3 |
Total assets |
€22,660.6 |
€15,830.8 |
Equity and liabilities |
|
|
Equity |
|
|
Share capital |
248.6 |
246.3 |
Capital reserve |
1,050.4 |
1,674.4 |
Treasury shares |
(10.3) |
(3.8) |
Retained earnings |
16,554.3 |
9,882.9 |
Other reserves |
523.3 |
93.9 |
Total equity |
€18,366.3 |
€11,893.7 |
Non-current
liabilities |
|
|
Loans and borrowings |
237.0 |
171.6 |
Other financial liabilities |
6.1 |
6.1 |
Income tax liabilities |
8.0 |
4.4 |
Provisions |
7.3 |
184.9 |
Contract liabilities |
53.8 |
9.0 |
Other liabilities |
17.4 |
12.8 |
Deferred
tax liabilities |
7.0 |
66.7 |
Total non-current liabilities |
€336.6 |
€455.5 |
Current liabilities |
|
|
Loans and borrowings |
37.0 |
129.9 |
Trade payables |
296.5 |
160.0 |
Other financial liabilities |
686.9 |
1,190.4 |
Government grants |
3.0 |
3.0 |
Refund liabilities |
— |
90.0 |
Income tax liabilities |
1,387.5 |
1,568.9 |
Provisions |
768.1 |
110.2 |
Contract liabilities |
673.9 |
186.1 |
Other
liabilities |
104.8 |
43.1 |
Total current liabilities |
€3,957.7 |
€3,481.6 |
Total liabilities |
€4,294.3 |
€3,937.1 |
Total equity and liabilities |
€22,660.6 |
€15,830.8 |
Interim Condensed Consolidated Statements
of Cash Flows
|
Three months ended September
30, |
NineSix months ended September,
30 |
|
2022 |
2021 |
2022 |
2021 |
(in millions) |
(unaudited) |
(unaudited, restated) |
(unaudited) |
(unaudited, restated) |
Operating activities |
|
|
|
|
Profit for the period |
€1,784.9 |
€3,211.0 |
€7,155.7 |
€7,126.3 |
Income
taxes |
659.2 |
1,456.4 |
2,625.8 |
3,206.2 |
Profit before tax |
€2,444.1 |
€4,667.4 |
€9,781.5 |
€10,332.5 |
Adjustments to reconcile profit before tax
to net cash flows: |
|
|
|
|
Depreciation and amortization of property,
plant, equipment, intangible assets and right-of-use assets |
33.5 |
19.8 |
94.3 |
49.2 |
Share-based payment expense |
59.7 |
23.1 |
81.7 |
62.4 |
Net foreign exchange differences |
116.2 |
(194.2) |
(222.3) |
(295.5) |
Loss on disposal of property, plant and
equipment |
0.2 |
— |
0.4 |
0.4 |
Finance income |
(7.7) |
(0.6) |
(226.5) |
(1.2) |
Finance expense |
4.3 |
82.7 |
16.8 |
303.0 |
Movements in government grants |
— |
(20.8) |
— |
(109.6) |
Net (gain) / loss on derivative
instruments at fair value through profit or loss |
(2.3) |
24.9 |
82.3 |
24.9 |
Working capital adjustments: |
|
|
|
|
Decrease / (increase) in trade and other
receivables, contract assets and other assets |
2,245.4 |
(3,343.9) |
5,016.7 |
(10,095.4) |
Decrease / (increase) in inventories |
72.9 |
(88.0) |
207.7 |
(329.3) |
Increase in trade payables, other
financial liabilities, other liabilities, contract liabilities,
refund liabilities and provisions |
565.9 |
332.9 |
760.3 |
1,153.9 |
Interest received |
4.3 |
0.4 |
6.5 |
1.0 |
Interest paid |
(4.3) |
(2.2) |
(16.5) |
(6.1) |
Income
tax paid |
(753.3) |
(0.7) |
(2,834.7) |
(1.0) |
Net cash flows from operating activities |
€4,778.9 |
€1,500.8 |
€12,748.2 |
€1,089.2 |
|
|
|
|
|
Investing activities |
|
|
|
|
Purchase of property, plant and
equipment |
(77.9) |
(40.5) |
(192.6) |
(88.1) |
Proceeds from sale of property, plant and
equipment |
0.4 |
0.2 |
0.4 |
1.4 |
Purchase of intangible assets and
right-of-use assets |
(4.7) |
(0.8) |
(26.2) |
(12.5) |
Purchase of financial instruments |
(1.1) |
— |
(31.1) |
— |
(Investment) / proceeds from maturity of
other financial assets |
— |
(367.0) |
375.2 |
(367.0) |
Net cash flows from / (used in) investing
activities |
€(83.3) |
€(408.1) |
€125.7 |
€(466.2) |
|
|
|
|
|
Financing activities |
|
|
|
|
Proceeds from issuance of share capital
and treasury shares, net of costs |
— |
— |
110.5 |
160.9 |
Proceeds from loans and borrowings |
0.4 |
— |
0.6 |
— |
Repayment of loans and borrowings |
— |
(0.5) |
(18.8) |
(1.9) |
Payments related to lease liabilities |
(10.0) |
(4.8) |
(31.9) |
(15.9) |
Share repurchase program |
(643.8) |
— |
(930.7) |
— |
Dividends |
— |
— |
(484.3) |
— |
Net cash flows from / (used in) financing
activities |
€(653.4) |
€(5.3) |
€(1,354.6) |
€143.1 |
|
|
|
|
|
Net increase in cash and cash
equivalents |
4,042.2 |
1,087.4 |
11,519.3 |
766.1 |
Change in cash and cash equivalents
resulting from exchange rate differences |
46.7 |
24.2 |
211.7 |
49.4 |
Cash and
cash equivalents at the beginning of the period |
9,334.8 |
914.1 |
1,692.7 |
1,210.2 |
Cash and cash equivalents at September 30 |
€13,423.7 |
€2,025.7 |
€13,423.7 |
€2,025.7 |
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