BioNTech Announces Third Quarter 2021 Financial Results and
Corporate Update
- Delivered more than 2 billion doses
of COMIRNATY/BNT162b2 in 2021 as of November 2nd
- Demonstrated progress in expanding
access to COVID-19 vaccine globally, including Biologics License
Application (BLA) approval by U.S. FDA, regulatory authorizations
of booster doses in multiple populations and first U.S. Emergency
Use Authorization (EUA) in children for a COVID-19 vaccine
- Expansion of clinical oncology
portfolio with first patient dosed in Phase 2 trial of mRNA-based
individualized immunotherapy autogene cevumeran (BNT122, RO7198457)
in circulating tumor DNA positive high-risk colorectal cancer
patients after adjuvant treatment
- Positive clinical data from
BioNTech’s oncology pipeline to be highlighted in seven
presentations at SITC 36th Annual Meeting; currently 15 product
candidates in 19 ongoing trials
Conference call and webcast scheduled for
November 9, 2021, at 8:00 a.m. ET (2:00 p.m. CET)
MAINZ, Germany, November 9, 2021 (GLOBE
NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the
Company”), a next-generation immunotherapy company pioneering novel
therapies for cancer and infectious diseases, today provided an
update on its corporate progress and reported financial results for
the third quarter and first nine months of 2021 ended
September 30, 2021.
“We continue to work diligently to respond to
global vaccine needs with a commitment to ensure equitable vaccine
access. Our robust clinical and regulatory strategy has led to
recent approvals that expand access to additional age groups,
highlighted by the first EUA for a COVID-19 vaccine in children 5
to under 12 years of age in the United States, and authorizations
for booster doses for multiple populations,” said Ugur
Sahin, M.D., CEO and Co-Founder of BioNTech. “We
also had a strong quarter with regard to our oncology pipeline. Our
approach to oncology addresses each patient’s unique needs by
leveraging multiple therapeutic platforms with combination
potential. With the recent dosing of the first patient with
autogene cevumeran in high-risk colorectal cancer patients after
adjuvant treatment, we now have four programs in Phase 2
development, as our pipeline advances into later-stage trials. We
are reporting positive clinical data across 6 of our oncology
programs at the upcoming SITC conference, including favorable
safety profiles and robust immune responses.”
Third Quarter 2021 and Subsequent
Updates
Infectious disease
Infectious disease is a growth pillar for
BioNTech, and the company is developing vaccine candidates to
address multiple pathogens that pose significant global public
health challenges.
COVID-19 Vaccine Program – BNT162b2
BNT162b2 clinical development updates
Multiple clinical trials are ongoing to expand
COVID-19 vaccine reach and explore booster doses to address waning
immunity. Clinical data to date support a third dose booster of the
vaccine in adults to augment vaccine protection over time. A third
booster dose of BNT162b2 confers high neutralizing antibody titers
against SARS-CoV-2 ancestral virus and the Beta and Delta variants.
The titers following a booster dose are higher than the levels
observed after the two-dose primary series. Additionally, studies
are underway evaluating variant-specific versions of the vaccine to
generate data to inform BioNTech and Pfizer’s strategy to address
emerging SARS-CoV-2 variants. While to date, there is no clinical
data suggesting the need for a variant-specific version of the
vaccine, the companies are establishing a preemptive prototype
approach to evaluate the development, manufacturing and regulatory
processes for variant specific vaccines. This prototype approach is
aimed to be substantiated by broad clinical data that are being
prepared for submission to regulatory authorities.
- In August 2021, BioNTech and Pfizer started a clinical trial to
evaluate the safety and immunogenicity of variant-encoding vaccine
candidates, including a multivalent vaccine against two variants of
concern. The study will enroll approximately 1,200 adults 18 to 85
years of age. Participants will receive a third 30 µg dose of a
multivalent Delta and Alpha version of the vaccine, or monovalent
Delta or Alpha versions administered six months after the second
dose of the two-dose primary series of BNT162b2. Vaccine- and
SARS-CoV-2-naïve participants in the study will receive two doses
of the multivalent Delta and Alpha vaccine administered 21 days
apart. First data from this study are anticipated in the fourth
quarter of 2021.
- On September 6, 2021, BioNTech and Pfizer announced data from a
Phase 3 safety and immunogenicity clinical trial of 306
participants 18 to 55 years of age who received a booster dose
approximately six months after completing the two-dose primary
regimen, with a median follow-up time of 2.6 months post-third
dose. The booster dose elicited significantly higher SARS-CoV-2
neutralizing antibody titers against the ancestral strain compared
to the levels observed after the two-dose primary series with
titers against ancestral virus more than 5 times as high at 1 month
after the third dose compared to 1 month after the two-dose primary
series. The safety profile was favorable and similar to the safety
profile after dose two of the primary series and generally
consistent with other clinical data for BNT162b2. Previously
reported Phase 1 data showed a similar pattern of third dose
responses against the ancestral strain, Beta and Delta variants.
Based on these data a third dose booster of BNT162b2 for emergency
use in certain population groups was authorized by the U.S. Food
and Drug Administration (FDA) and the Conditional Marketing
Authorization (CMA) in the European Union was updated upon approval
from the European Commission (EC) following a positive opinion from
the European Medicines Agency (EMA) for a booster dose of the
COVID-19 vaccine from BioNTech and Pfizer. The data are also being
submitted to other regulatory authorities worldwide.
- On September 20, 2021, BioNTech and Pfizer announced positive
topline results from a Phase 2/3 trial in children demonstrating
strong immune response one month after the second dose in 2,268
children aged 5 to under 12 years. The vaccine showed a favorable
safety profile and robust neutralizing antibody responses in this
cohort using a two-dose regimen of 10 µg administered 21 days
apart. Antibody responses were comparable to those in a previous
study in people 16 to 25 years of age immunized with 30 µg doses.
One month after the second dose, the geometric mean ratio of
SARS-CoV-2 neutralizing titers in the children aged 5 to under 12
years to those in people 16 to 25 years of age was 1.04, meeting
the predefined immunobridging success criteria. These data compare
immune responses between a vaccine candidate and an approved
vaccine. These data were recently submitted for publication in a
peer-reviewed journal.
- Subsequently, on October 26, 2021, the companies reported
further results from the Phase 2/3 trial in children that included
an additional 2,379 children, from the supplemental safety group,
bringing the total to approximately 4,500. In this analysis,
BNT162b2 showed a favorable safety profile, robust immune responses
as well as a vaccine efficacy rate of 90.7% in participants without
prior SARS-CoV-2 infection, measured 7 days after the second dose,
during a period when Delta was the prevalent strain. Topline
readouts for the other two age cohorts from the trial – children 2
to <5 years of age and children 6 months to <2 years of age –
are expected as soon as the fourth quarter of 2021 or early first
quarter 2022.
- On October 21, 2021, BioNTech and Pfizer announced topline
results from a Phase 3 clinical trial to evaluate the safety,
tolerability and efficacy of a 30 µg booster dose versus placebo in
more than 10,000 participants aged 16 years and older who
previously received two doses of BNT162b2 at least six months prior
to randomization. These first results from a randomized, controlled
COVID-19 vaccine booster dose trial demonstrated that a booster
dose restored vaccine protection to the high levels achieved after
the second dose, showing a relative vaccine efficacy of 95.6%
compared to those who did not receive a booster dose. Multiple
subgroup analyses showed efficacy was consistent irrespective of
age, sex, race, ethnicity and co-morbidities. The adverse event
profile was consistent with previous clinical safety data. The
companies plan to share these data with the FDA, EMA, and other
regulatory agencies and submit detailed results for publication in
a peer-reviewed journal.
- A global Phase 2/3 trial to evaluate the safety, tolerability
and immunogenicity of BNT162b2 in preventing COVID-19 in healthy
pregnant women 18 years of age and older is ongoing. The study will
also assess safety in infants of vaccinated pregnant women and the
transfer of potentially protective antibodies to their
infants.
Regulatory updates
BioNTech and Pfizer have made progress on the
regulatory front, including Biologics License Application (BLA)
approval in the United States, as well as U.S. Emergency Use
Authorization (EUA) for booster doses for many populations at high
risk of severe COVID-19-disease. The EMA issued a positive opinion
on the administration of BNT162b2 as a booster dose in adults and
as a third dose in immunocompromised people.
- In August 2021, the U.S. FDA and the EMA authorized the
extension of the shelf-life of the COVID-19 vaccine from six to
nine months when stored at -90 to -60 degrees C.
- On August 23, 2021, the U.S. FDA approved the BLA for BNT162b2
to prevent COVID-19 in individuals 16 years of age and older based
on a comprehensive data package that included longer-term follow-up
data from the Phase 3 trial. BNT162b2 is the first COVID-19 vaccine
to be granted full approval by the FDA.
- On September 22, 2021, the U.S. FDA authorized a third dose
booster for emergency use in individuals 65 years of age and older,
individuals 18 through 64 years of age at high risk of severe
COVID-19, and individuals 18 through 64 years of age whose frequent
institutional or occupational exposure to SARS-CoV-2 puts them at
high risk of serious complications from COVID-19 including severe
COVID-19. The booster dose, which is the same formulation and
dosage as used in the primary series, is to be administered at
least six months after completion of the primary series. A third
dose was authorized on August 12, 2021, under the EUA for
administration to individuals at least 12 years of age who have
undergone solid organ transplantation, or who are diagnosed with
conditions that are considered to have an equivalent level of
immunocompromise.
- On October 5, 2021, the EC granted a variation to the CMA for
the administration of a third dose booster of BNT162b2 at least six
months after the second dose in individuals 18 years of age and
older. This followed a positive opinion from the Committee for
Medicinal Products for Human Use (CHMP) of the EMA. The positive
opinion follows the companies’ submission of a variation to the EMA
requesting to update the CMA with data supporting a booster dose to
prevent COVID-19 in individuals 16 years of age and older. The CHMP
also recommended that people with severely weakened immune systems
should be given a third dose of the vaccine at least 28 days after
their second dose.
- In October 2021, BioNTech and Pfizer announced the submission
of data supporting the vaccination of children 5 to under 12 years
of age to the EMA for a variation of the CMA in the European Union.
The variation request includes data from the Phase 2/3 study, which
is enrolling children 6 months to under 12 years of age. The data
will also be filed with other regulatory authorities in the coming
weeks.
- On October 29, 2021, BioNTech and Pfizer received the first
U.S. FDA EUA of a COVID-19 vaccine in children ages 5 through 11
years of age based on data from a Phase 2/3 randomized, controlled
trial. This EUA follows the FDA’s Vaccines and Related Biological
Products Advisory Committee (VRBPAC) vote on October 26, 2021,
recommending that the FDA grant EUA in this population.
- In November 2021, the EC authorized a new formulation of
BNT162b2, that further simplifies vaccine handling. This decision
followed a positive opinion from the EMA CHMP. The new formulation
also allows for longer storage, as vials can be stored for 10 weeks
at refrigerator temperatures from 2°C to 8°C, and after first
puncture, can be stored and transported at 2°C to 30°C and used
within 12 hours.
Commercial updates
BioNTech and Pfizer have delivered an aggregate
of over 2 billion doses of BNT162b2 vaccine to more than 152
countries and territories around the world as of November 2,
2021.Further discussions for additional dose commitments are
ongoing for 2022 and beyond.
- On September 22, 2021, BioNTech and Pfizer announced plans to
expand the existing agreement with the U.S. government by providing
an additional 500 million doses at a not-for-profit price for
donation to low- and lower-middle-income countries and the
organizations that support them. This expanded agreement brings the
total number of doses to be supplied to the U.S. government for
donation to one billion. The companies are committed to working
toward equitable and affordable access to COVID-19 vaccines for all
people around the world, actively working with governments and
health partners worldwide, and have pledged to provide two billion
doses to low- and middle-income countries in 2021 and 2022.
- In October 2021, the Japanese government agreed to purchase
another 120 million doses starting in January 2022, bringing the
total number of doses purchased to 314 million.
- On October 28, 2021, BioNTech and Pfizer announced that the
U.S. government purchased an additional 50 million doses to
continue to support preparedness for pediatric vaccinations,
including securing vaccines for children under 5 years of age. With
this purchase, the U.S. government has exercised its final purchase
option under the existing supply agreement, bringing the total
number of doses secured under the agreement to 600 million,
excluding the one billion doses to be supplied at a not-for-profit
price for donation.
Manufacturing Updates
BioNTech and Pfizer expect to manufacture 2.7
billion to 3 billion doses by the end of 2021 and anticipate
capacity to manufacture up to four billion doses in 2022. The
companies have developed a global COVID-19 vaccine supply chain and
manufacturing network, which now spans four continents and includes
more than 20 manufacturing facilities.
- On August 26, 2021, BioNTech and Pfizer announced the signing
of a letter of intent with Eurofarma Laboratórios SA, a Brazilian
biopharmaceutical company, to manufacture vaccine for distribution
within Latin America. Eurofarma will obtain drug product from
facilities in the United States, and manufacturing of finished
doses is expected to commence in 2022. At full operational
capacity, annual production is expected to exceed 100 million
finished COVID-19 doses.
Influenza Vaccine Program
- BNT161 – On September 27, 2021, the first participants were
dosed in a Phase 1 clinical trial to evaluate the safety,
tolerability and immunogenicity of a single dose quadrivalent mRNA
vaccine (BNT161) against influenza in healthy adults 65 to 85 years
of age, with an FDA-approved standard quadrivalent influenza
vaccine as a control. BNT161 encodes World Health Organization
recommended strains. Data from the trial is expected in the first
half of 2022. BNT161 is partnered with Pfizer.
Other Infectious Disease
BioNTech is committed to developing vaccines and
sustainable end-to-end vaccine production on the African continent
and to provide affordable access to low- and lower-middle-income
countries. The company has continued its efforts to establish the
necessary infrastructure and to grow its infectious disease
pipeline.
- On July 26, 2021, BioNTech announced plans to develop
sustainable solutions to address infectious diseases on the African
continent. BioNTech aims to develop an mRNA-based malaria vaccine
and the initiation of a clinical trial is expected by end of
2022.
- On October 26, 2021, BioNTech announced that construction of
the first mRNA manufacturing facility in Africa is expected to
begin in mid-2022, following the signing of a Memorandum of
Understanding with the Rwandan government and the Institut Pasteur
de Dakar (Senegal). BioNTech believes this facility could become
the first node in a decentralized and robust African end-to-end
manufacturing network with an expected annual manufacturing
capacity of several hundreds of million mRNA vaccine doses to
provide sustainable vaccine supply on the African continent.
- The company also announced that clinical trials for its first
tuberculosis vaccine candidate are planned to begin by end of 2022,
just two years after the program was initiated. BioNTech has
collaborated with the Bill and Melinda Gates Foundation since 2019
to develop preclinical vaccine and immunotherapy candidates to
prevent HIV and tuberculosis infection.
Oncology
BioNTech is advancing the development of a broad
oncology pipeline, which spans multiple anti-tumor and
immune-modulating approaches. BioNTech’s clinical pipeline now
includes randomized Phase 2 clinical trials for FixVac programs,
BNT111 and BNT113, and for iNeST product candidate autogene
cevumeran (BNT122, RO7198457), bringing the company’s clinical
programs to a total of 15 product candidates in 19 ongoing clinical
trials including four phase 2 randomized clinical trials. BioNTech
expects to further advance its oncology pipeline in the fourth
quarter of 2021 with one preclinical program expected to move into
a first-in-human Phase 1 trial.Seven updates (from 6 oncology
programs) with positive clinical and preclinical data supporting
BioNTech’s oncology pipeline will be presented at the Society for
Immunotherapy of Cancer’s (SITC) 36th Annual Meeting which takes
place on November 10–14, 2021. The information below regarding the
SITC presentations reflects data in submitted abstracts and
supplemental data may be presented at the conference.
mRNA programsFixVac
These product candidates leverage the company's
proprietary pharmacologically optimized uridine mRNA and its
proprietary intravenous lipoplex formulation.
- BNT111 – A global, three-arm Phase 2 trial evaluating BNT111 in
combination with cemiplimab (Regeneron and Sanofi’s Libtayo®),
versus both agents as monotherapy, in patients with
anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma
is ongoing. The trial is being conducted in collaboration with
Regeneron.
On September 15, 2021, the U.S. FDA granted
Orphan Drug Designation to BNT111 for the treatment of Stage IIB
through IV melanoma. At SITC, BioNTech intends to present
additional data from the ongoing Phase 1 trial evaluating the
safety and tolerability of BNT111 in patients with advanced
melanoma. Data demonstrated that the immunogenicity and safety
profile of BNT111 as a monotherapy were comparable in patients
grouped as having evidence of disease (ED) and in patients with no
evidence of disease (NED). As of May 24, 2021, 14 of 22 (64%)
patients with ED and 19 of 28 (68%) patients with NED demonstrated
BNT111-induced T-cell responses against at least one
tumor-associated antigen (TAA). In NED patients, clinical efficacy
was promising with median disease-free survival of 34.8 months.
- BNT112 – At SITC, BioNTech intends to present data from the
ongoing Phase 1/2 trial of BNT112 as a monotherapy and in
combination with cemiplimab in patients with metastatic
castration-resistant prostate cancer (mCRPC) and newly diagnosed
high-risk localized prostate cancer (LPC). Overall, as of June 22,
2021, the data suggest that BNT112 as monotherapy and in
combination with a PD-1 inhibitor (cemiplimab) is well-tolerated in
mCRPC. Additionally, data suggest that BNT112 induces robust immune
responses, as de novo induction and expansion of pre-existing
antigen-specific T-cell responses was observed in all patients with
available Post-IVS-ELISpot.
- BNT113 – A randomized Phase 2 trial evaluating BNT113 in
combination with pembrolizumab versus pembrolizumab monotherapy as
a first-line treatment in patients with unresectable recurrent or
metastatic HPV16+ head and neck squamous cell carcinoma (HNSCC)
expressing PD-L1 is ongoing.
Individualized neoantigen specific immunotherapy
(iNeST)
- Autogene Cevumeran (BNT122) – BioNTech’s iNeST product
candidate autogene cevumeran is also based on the company's
proprietary pharmacologically optimized uridine mRNA and its
proprietary intravenous lipoplex formulation, and is partnered with
Genentech. In October 2021, BioNTech announced that the first
patient was dosed in a randomized Phase 2 trial in the adjuvant
treatment of circulating tumor DNA (ctDNA) positive, surgically
resected Stage II (high-risk)/Stage III colorectal cancer. The
trial plans to enroll about 200 patients to evaluate the efficacy
of autogene cevumeran compared to watchful waiting after surgery
and chemotherapy, the current standard of care for these high-risk
patients. The primary endpoint for the study is disease-free
survival. Secondary objectives include overall survival and safety.
The trial has been initiated in the United States, Germany, Spain
and Belgium.
The medical need for novel therapies to treat
colorectal cancer, the second deadliest cancer worldwide, remains
high. The current standard of care in this indication is watchful
waiting to see if tumors recur after removal of the primary tumor
and adjuvant chemotherapy. A proportion of these patients are
expected to have a recurrence of their tumor within 2 to 3 years
after their surgery. For this clinical trial, patients at high risk
for recurrence will be selected by means of a highly sensitive
blood test detecting ctDNA.
RiboMabs
BioNTech’s RiboMab product candidates, BNT141
and BNT142, are designed to encode secreted antibodies. These
product candidates leverage the company’s proprietary
nucleoside-modified mRNA which is designed to minimize the
immunomodulatory activity of the mRNA.
- BNT141 – BioNTech plans to start a Phase 1 clinical trial for
BNT141 in the fourth quarter of 2021.
- BNT142 – BioNTech now plans to start a Phase 1 clinical trial
for BNT142 in the first half of 2022.
AntibodiesNext-generation checkpoint
immunomodulators
BNT311 and BNT312 are partnered with Genmab as
part of a 50/50 collaboration in which development costs and future
profit are shared.
- BNT311/GEN1046 – A Phase 1/2 trial with multiple expansion
cohorts in patients with solid tumors is ongoing.
At SITC, BioNTech intends to present exploratory
pharmacodynamic analyses and potential biomarkers of response in an
expansion cohort of patients with metastatic or unresectable NSCLC
who had multiple lines of prior systemic therapy, including a
checkpoint inhibitor. As of May 2021, 40 patients were enrolled and
BNT311 elicited pharmacodynamic effects consistent with its
proposed mechanism of action. In addition, relationships between
disease control and PD-L1 tumoral expression, as well as time from
last prior anti-PD-1 therapy were observed.A Phase 2 trial of
BNT311 as monotherapy and in combination with pembrolizumab in
patients with recurrent/refractory metastatic non-small cell lung
cancer is planned to start in the fourth quarter of 2022.
- BNT312/GEN1042 – A Phase 1/2 trial with multiple expansion
cohorts in patients with solid tumors is ongoing.
At SITC, BioNTech intends to report, in a
mini-oral presentation, clinical data from the dose escalation part
of the ongoing Phase 1/2 trial. Overall the data demonstrated a
favorable safety profile in patients with advanced solid tumors, as
well as biologic and early antitumor activity. As of June 11, 2021,
disease control was achieved in 25 of 49 (51%) patients, including
two confirmed partial responses per RECIST1.1 in melanoma and
neuroendocrine lung cancer.
Cell therapiesCAR-T cell
immunotherapy
- BNT211 – A first-in-human Phase 1/2 open-label dose escalation
and dose expansion trial evaluating BNT211 in patients with
Claudin-6-positive solid tumors is ongoing.
At SITC, BioNTech intends to present data from
this trial. Overall, as of July 23, 2021, Claudin-6 CAR-T cells
dosed as monotherapy and in combination with Claudin-6 CARVac
showed a favorable safety profile at doses tested with encouraging
signs of efficacy. At the first tumor assessment six weeks after
adoptive T-cell transfer for the five evaluable patients, four
patients showed stable disease (SD) and one patient showed
progressive disease (PD). Three patients showed initial tumor
shrinkage per RECIST1.1.
Neoantigen-targeting T-cell therapy
- BNT221 – A first-in-human Phase 1 dose escalation trial
evaluating BNT221 in patients with checkpoint inhibitor
unresponsive or refractory metastatic melanoma is ongoing. At SITC,
preclinical data demonstrating NEOSTIM's ability to induce CD8+ and
CD4+ T-cell responses using peripheral blood mononuclear cells from
patients with ovarian cancer will be presented. These responses
were polyfunctional, specific and have the capacity to
degranulate.
Small molecule immunomodulatorsToll-like
receptor binding agonist
- BNT411 – A Phase 1/2 dose-escalation trial of BNT411 as a
monotherapy in patients with solid tumors and in combination with
atezolizumab, carboplatin and etoposide in patients with
chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC)
is ongoing.
At SITC, BioNTech intends to present preliminary
clinical data from the Phase 1/2 trial. Overall, as of July 1,
2021, BNT411 demonstrated an acceptable safety profile at all doses
tested as a monotherapy and in combination with atezolizumab,
carboplatin and etoposide. Pharmacodynamic signals were encouraging
and showed a strong induction of type 1 interferon-dominated
cytokines in line with the proposed mechanism of action. BNT411 has
shown early signal of prolonging stable disease even in heavily
pre-treated patients including post-anti-PD-1. Both
pharmacodynamics and anti-tumor responses warrant further expansion
in various indications either as a monotherapy or in combination
with other standard-of-care treatments.
Corporate Updates
- In October 2021, BioNTech expanded its infectious disease
portfolio capabilities by acquiring PhagoMed Biopharma GmbH, an
Austrian biotechnology company, specialized in the development of a
new class of antibacterials.
Third Quarter 2021 Financial Results
Revenues: Total revenues were estimated to be
€6,087.3 million1 for the three months ended
September 30, 2021, compared to €67.5 million for the
three months ended September 30, 2020. For the nine months
ended September 30, 2021, total revenues were estimated to be
€13,444.2 million1 compared to €136.9 million for the
comparative prior year period. The increase was mainly due to rapid
increases in the supply and sales of the COVID-19 vaccine
worldwide. Under the collaboration agreements, territories have
been allocated between BioNTech, Pfizer and Fosun Pharma based on
marketing and distribution rights. During the three months ended
September 30, 2021, BioNTech’s commercial revenues included an
estimated amount of €4,341.5 million1 gross profit share and
€17.0 million of sales milestones. During the nine months
ended September 30, 2021, BioNTech’s commercial revenues
included an estimated amount of €9,769.9 million1 gross profit
share and €432.8 million of sales milestones. 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, 2021, respectively,
€312.3 million and €514.3 million sales to BioNTech’s
collaboration partners of products manufactured by BioNTech as well
as €1,350.8 million and €2,586.2 million direct COVID-19
vaccine sales to customers in BioNTech’s territory, Germany and
Turkey, have been recognized.
Cost of Sales: Cost of sales were estimated to
be €1,211.4 million1 for the three months ended
September 30, 2021, compared to €6.8 million for the
three months ended September 30, 2020. For the nine months
ended September 30, 2021, cost of sales were estimated to be
€2,328.3 million1, compared to €18.3 million for the
comparative prior year period. During the three and nine months
ended September 30, 2021, estimated cost of sales of
€1,194.8 million1 and €2,290.1 million1, respectively,
were recognized with respect to BioNTech’s COVID-19 vaccine sales
and include the share of gross profit that BioNTech owes its
collaboration partner Pfizer based on its sales.
Research and Development Expenses: Research and
development expenses were €260.4 million for the three months
ended September 30, 2021, compared to €227.7 million for
the three months ended September 30, 2020. For the nine months
ended September 30, 2021, research and development expenses
were €677.7 million, compared to €388.0 million for the
comparative prior year period. The increase was mainly due to an
increase in research and development expenses from the BNT162
program. The increase was further driven by an increase in wages,
benefits and social security expenses following an increase in
headcount, the recognition of inventor compensation expenses as
well as expenses incurred under share-based-payment
arrangements.
General and Administrative Expenses: General and
administrative expenses were €68.2 million for the three
months ended September 30, 2021, compared to
€23.5 million for the three months ended September 30,
2020. For the nine months ended September 30, 2021, general
and administrative expenses were €154.9 million, compared to
€58.1 million for the comparative prior year period. The
increase was mainly due to an increase in wages, benefits and
social security expenses following an increase in headcount and
expenses incurred under the share-based-payment arrangements,
increased expenses for purchased management consulting and legal
services as well as higher insurance premiums caused by the
increased business volume.
Income Taxes: Interim income taxes were accrued
in an amount of €1,456.4 million and €3,206.2 million for
the three and nine months ended September 30, 2021,
respectively, and were recognized using the estimated annual
effective income tax rate of approximately 31%.Net Profit/(Loss):
Net profit was €3,211.0 million for the three months ended
September 30, 2021, compared to €210.0 million net loss
for the three months ended September 30, 2020. For the nine
months ended September 30, 2021, net profit was
€7,126.3 million, compared to €351.7 million net loss for
the comparative prior year period.
Cash Position: Cash and cash equivalents as of
September 30, 2021 were €2,392.7 million. In addition,
trade receivables remained outstanding which is 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. Consequently,
these trade receivables which are subject to this temporal offset
and were outstanding as of September 30, 2021 were received as
payments in October 2021, improving BioNTech’s cash position.
Shares Outstanding: Shares outstanding as of
September 30, 2021 were 242,516,955.
Updated Outlook for the 2021 Financial
YearUpdate on COVID-19 Vaccine Planned Deliveries for the 2021
Financial Year:
- Estimated BioNTech COMIRNATY/COVID-19 vaccine revenues for the
full 2021 financial year based on up to 2.5 billion doses: ~€16
billion to €17 billion2
|
- This revenue estimate reflects:
- Expected revenues from direct COVID-19 vaccine sales to
customers in BioNTech’s territory
- Expected revenues from sales to collaboration partners of
products manufactured by BioNTech
- Expected sales milestone payments from collaboration
partners
- Expected revenues related to share of gross profit from
COVID-19 vaccine sales in the collaboration partners’
territories
|
Planned 2021 Financial Year Expenses and
Capex2:
- Previous cost guidance maintained for the full 2021 financial
year
|
R&D expenses |
€950
million - €1,050 million |
SG&A expenses |
€250
million - €300 million |
Capital expenditures |
€175
million - €225 million |
- Further ramp-up of R&D investment in Q4 2021 planned to
expand and accelerate the pipeline development
|
- Ranges reflect current base case projections
|
Estimated 2021 Financial Year Tax
Assumptions:
BioNTech Group estimated annual effective income tax rate: |
~31% |
The full interim unaudited condensed
consolidated financial statements can be found in BioNTech’s Report
on Form 6-K, filed today with the SEC and available at
https://www.sec.gov/. 1Estimated figures based on preliminary data
shared between the collaboration partner and BioNTech as fully
described in the Annual Report on Form 20-F as well as the
Quarterly Report as of and for the Three and Nine Months Ended
September 30, 2021, filed as an exhibit to BioNTech’s Current
Report on Form 6-K. Changes in the share of the collaboration
partners’ gross profit will be recognized prospectively.2Figures
have been estimated at constant foreign exchange rates.
About BioNTechBiopharmaceutical New
Technologies 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
checkpoint immuno-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, Bayer Animal Health, Genentech, a member of the
Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer.
For more information, please visit
www.BioNTech.de
Forward-Looking StatementsThis press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, as amended,
including, but not limited to, statements concerning: BioNTech's
expected revenues and net profit related to sales of BioNTech's
COVID-19 vaccine, referred to as COMIRNATY® where approved for use
under full or conditional marketing authorization, in territories
controlled by BioNTech's collaboration partners, particularly for
those figures that are derived from preliminary estimates provided
by BioNTech's partners; BioNTech's pricing and coverage
negotiations with governmental authorities, private health insurers
and other third-party payors after BioNTech's initial sales to
national governments; the extent to which initial or booster doses
of a COVID-19 vaccine continue to be necessary in the future;
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 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
collaboration between BioNTech and Pfizer to develop a COVID-19
vaccine (including a potential booster dose of BNT162b2 and/or a
potential booster dose of a variation of BNT162b2 having a modified
mRNA sequence); the ability of BNT162b2 to prevent COVID-19 caused
by emerging virus variants; BioNTech's ability to identify research
opportunities and discover and develop investigational medicines;
the ability and willingness of BioNTech's third-party collaborators
to continue research and development activities relating to
BioNTech's development candidates and investigational medicines;
the impact of the COVID-19 pandemic on BioNTech's development
programs, supply chain, collaborators and financial performance;
unforeseen safety issues and claims for personal injury or death
arising from the use of BioNTech's COVID-19 vaccine and other
products and product candidates developed or manufactured by us;
BioNTech's ability to progress BioNTech's Malaria, Tuberculosis and
HIV programs, including timing for selecting clinical candidates
for these programs and the commencement of a clinical trial, as
well as any data readouts; the nature of the collaboration with the
African Union and the Africa CDC; the nature and duration of
support from WHO, the European Commission and other organizations
with establishing infrastructure; the development of sustainable
vaccine production and supply solutions on the African continent
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, 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 oBioNTech'sur 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 quarterly report 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 for the three
and nine months ended September 30, 2021 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 quarterly
report 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.
Investor RelationsSylke Maas, Ph.D. VP
Investor Relations & Strategy Tel: +49 (0)6131 9084 1074
E-mail: Investors@biontech.de
Media RelationsJasmina AlatovicSenior Director Global
External Communications Tel: +49 (0)6131 9084 1513 or +49 (0)151
1978 1385 E-mail: Media@biontech.de
Interim Condensed Consolidated Statements of
Profit or Loss
|
|
|
Three months ended September 30, |
Nine months ended September 30, |
|
|
|
2021 |
2020 |
2021 |
2020 |
(in
millions, except per share data) |
|
|
(unaudited) |
(unaudited) |
(unaudited) |
(unaudited) |
|
|
|
|
|
|
|
Revenues |
|
|
|
|
|
|
Research & development revenues |
|
|
€47.2 |
€59.7 |
€96.1 |
€113.4 |
Commercial revenues |
|
|
6,040.1 |
7.8 |
13,348.1 |
23.5 |
Total
revenues |
|
|
€6,087.3 |
€67.5 |
€13,444.2 |
€136.9 |
|
|
|
|
|
|
|
Cost of sales |
|
|
(1,211.4) |
(6.8) |
(2,328.3) |
(18.3) |
Research and development expenses |
|
|
(260.4) |
(227.7) |
(677.7) |
(388.0) |
Sales and marketing expenses |
|
|
(10.5) |
(4.3) |
(32.5) |
(7.8) |
General and administrative expenses |
|
|
(68.2) |
(23.5) |
(154.9) |
(58.1) |
Other operating expenses |
|
|
(26.4) |
(0.4) |
(27.3) |
(1.3) |
Other operating income |
|
|
213.1 |
8.8 |
360.6 |
10.0 |
Operating income / (loss) |
|
|
€4,723.5 |
€(186.4) |
€10,584.1 |
€(326.6) |
|
|
|
|
|
|
|
Finance income |
|
|
26.6 |
0.5 |
51.4 |
1.1 |
Finance expenses |
|
|
(81.9) |
(21.1) |
(301.0) |
(24.5) |
Interest expenses related to lease
liabilities |
|
|
(0.8) |
(0.5) |
(2.0) |
(1.4) |
Profit / (loss) before tax |
|
|
€4,667.4 |
€(207.5) |
€10,332.5 |
€(351.4) |
|
|
|
|
|
|
|
Income
taxes |
|
|
(1,456.4) |
(2.5) |
(3,206.2) |
(0.3) |
Profit / (loss) for the period |
|
|
€3,211.0 |
€(210.0) |
€7,126.3 |
€(351.7) |
|
|
|
|
|
|
|
Earnings per share |
|
|
|
|
|
|
Basic profit / (loss) for the
period per share |
€13.14 |
€(0.88) |
€29.22 |
€(1.51) |
Diluted profit /
(loss) for the period per share |
€12.35 |
€(0.88) |
€27.46 |
€(1.51) |
Interim Condensed Consolidated Statements of
Financial Position
|
|
|
September 30, |
December 31, |
(in
millions) |
|
|
2021 |
2020 |
Assets |
|
|
(unaudited) |
|
Non-current assets |
|
|
|
|
Intangible assets |
|
|
€162.9 |
€163.5 |
Property, plant and equipment |
|
|
294.4 |
227.0 |
Right-of-use assets |
|
|
147.7 |
99.0 |
Other assets |
|
|
0.9 |
1.0 |
Deferred
tax assets |
|
|
75.3 |
161.2 |
Total
non-current assets |
|
|
€681.2 |
€651.7 |
Current assets |
|
|
|
|
Inventories |
|
|
393.4 |
64.1 |
Trade and other receivables |
|
|
10,603.9 |
165.5 |
Other financial assets |
|
|
1.8 |
137.2 |
Other assets |
|
|
109.3 |
61.0 |
Income tax assets |
|
|
0.9 |
0.9 |
Deferred expenses |
|
|
49.4 |
28.0 |
Cash and cash equivalents |
|
|
2,392.7 |
1,210.2 |
Total current assets |
|
|
€13,551.4 |
€1,666.9 |
Total
assets |
|
|
€14,232.6 |
€2,318.6 |
|
|
|
|
|
Equity
and liabilities |
|
|
|
|
Equity |
|
|
|
|
Share capital |
|
|
246.3 |
246.3 |
Capital reserve |
|
|
1,674.4 |
1,514.5 |
Treasury shares |
|
|
(3.8) |
(4.8) |
Retained earnings / (accumulated
losses) |
|
|
6,716.7 |
(409.6) |
Other reserves |
|
|
77.9 |
25.4 |
Total equity |
|
|
€8,711.5 |
€1,371.8 |
Non-current liabilities |
|
|
|
|
Interest-bearing loans and borrowings |
|
|
267.7 |
231.0 |
Other financial liabilities |
|
|
324.9 |
31.5 |
Provisions |
|
|
5.7 |
5.5 |
Contract liabilities |
|
|
10.5 |
71.9 |
Other liabilities |
|
|
9.7 |
0.6 |
Deferred
tax liabilities |
|
|
— |
0.3 |
Total
non-current liabilities |
|
|
€618.5 |
€340.8 |
Current liabilities |
|
|
|
|
Interest-bearing loans and borrowings |
|
|
19.0 |
9.1 |
Trade payables |
|
|
258.9 |
102.3 |
Other financial liabilities |
|
|
924.5 |
74.1 |
Government grants |
|
|
3.1 |
92.0 |
Income tax liabilities |
|
|
3,118.4 |
— |
Provisions |
|
|
189.7 |
0.9 |
Contract liabilities |
|
|
284.2 |
299.6 |
Other
liabilities |
|
|
104.8 |
28.0 |
Total
current liabilities |
|
|
€4,902.6 |
€606.0 |
Total
liabilities |
|
|
€5,521.1 |
€946.8 |
Total
equity and liabilities |
|
|
€14,232.6 |
€2,318.6 |
Interim Condensed Consolidated Statements of
Cash Flows
|
|
Three months ended September 30, |
Nine months ended September 30, |
|
|
2021 |
2020 |
2021 |
2020 |
(in
millions) |
|
(unaudited) |
(unaudited) |
(unaudited) |
(unaudited) |
|
|
|
|
|
|
Operating activities |
|
|
|
|
|
Profit / (loss) for the period |
|
€3,211.0 |
€(210.0) |
€7,126.3 |
€(351.7) |
Income
taxes |
|
1,456.4 |
2.5 |
3,206.2 |
0.3 |
Profit
/ (loss) before tax |
|
€4,667.4 |
€(207.5) |
€10,332.5 |
€(351.4) |
Adjustments to reconcile profit / (loss)
before tax to net cash flows: |
|
|
|
|
|
Depreciation and amortization of property, plant, equipment and
intangible assets |
|
19.8 |
8.8 |
49.2 |
26.2 |
Share-based payment expense |
|
23.1 |
8.1 |
62.4 |
24.8 |
Net foreign exchange differences |
|
(194.2) |
0.1 |
(295.5) |
— |
Gain on disposal of property, plant and equipment |
|
— |
0.6 |
0.4 |
0.7 |
Finance income |
|
(0.6) |
(0.5) |
(1.2) |
(1.1) |
Interest on lease liability |
|
0.8 |
0.5 |
2.0 |
1.4 |
Finance expense |
|
81.9 |
7.1 |
301.0 |
7.3 |
Movements in government grants |
|
(20.8) |
(8.5) |
(109.6) |
(8.5) |
Other non-cash income |
|
24.9 |
— |
24.9 |
(0.2) |
Working capital adjustments: |
|
|
|
|
|
Increase in trade and other receivables, contract assets and other
assets |
|
(3,343.9) |
(45.1) |
(10,095.4) |
(54.9) |
Increase in inventories |
|
(88.0) |
(3.7) |
(329.3) |
(0.5) |
Increase in trade payables, other financial liabilities, other
liabilities, contract liabilities and provisions |
|
332.9 |
47.8 |
1,153.9 |
94.5 |
Interest received |
|
0.4 |
0.2 |
1.0 |
0.8 |
Interest paid |
|
(2.2) |
(0.6) |
(6.1) |
(1.6) |
Income
tax received / (paid), net |
|
(0.7) |
0.2 |
(1.0) |
(0.2) |
Net
cash flows from / (used in) operating activities |
|
€1,500.8 |
€(192.5) |
€1,089.2 |
€(262.7) |
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
Purchase of property, plant and
equipment |
|
(40.5) |
(19.3) |
(88.1) |
(40.7) |
Proceeds from sale of property, plant and
equipment |
|
0.2 |
— |
1.4 |
— |
Purchase of intangibles assets and
right-of-use assets |
|
(0.8) |
(1.0) |
(12.5) |
(5.2) |
Acquisition of subsidiaries and
businesses, net of cash acquired |
|
— |
— |
— |
0.9 |
Net cash flows used in investing activities |
|
€(41.1) |
€(20.3) |
€(99.2) |
€(45.0) |
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
Proceeds from issuance of share capital
and treasury shares, net of costs |
|
— |
532.3 |
160.9 |
680.1 |
Proceeds from loans and borrowings |
|
— |
99.5 |
— |
102.4 |
Repayment of loans and borrowings |
|
(0.5) |
(0.6) |
(1.9) |
(0.9) |
Payments
related to lease liabilities |
|
(4.8) |
(1.0) |
(15.9) |
(3.2) |
Net
cash flows from / (used in) financing activities |
|
€(5.3) |
€630.2 |
€143.1 |
€778.4 |
|
|
|
|
|
|
Net increase in cash and cash
equivalents |
|
1,454.4 |
417.4 |
1,133.1 |
470.7 |
Change in cash and cash equivalents
resulting from exchange rate differences |
|
24.2 |
0.1 |
49.4 |
0.7 |
Cash and
cash equivalents at the beginning of the period |
|
914.1 |
573.0 |
1,210.2 |
519.1 |
Cash
and cash equivalents at September 30 |
|
€2,392.7 |
€990.5 |
€2,392.7 |
€990.5 |
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