Warum Fällt Biontech Aktie

Delivered more than 2 exchange rate doses von COMIRNATY/BNT162b2 bei 2021 as of november 2ndDemonstrated progress bei expanding accessibility to covid19 vaccine globally, consisting of Biologics patent Application (BLA) approval von U.S. FDA, regulation authorizations von booster doses in multiple populations and first U.S. Notfall Use Authorization (EUA) bei children zum a covid-19 vaccineExpansion von clinical oncology investment portfolio with first patient dosed bei Phase 2 trial of mRNA-based individualized immunotherapy autogene cevumeran (BNT122, RO7198457) an circulating tumor DNA confident high-risk colorectal cancer patient after adjuvant treatmentPositive clinical säule from BioNTech’s oncology pipeline to be highlighted bei seven presentations punkt SITC 36th annual Meeting; currently fünfzehn product candidates an 19 recurring trials

Conference call und webcast scheduled weil das november 9, 2021, weist 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 und infectious diseases, heute provided in update top top its that company progress und reported jae won results weil das the third quarter and first ripe months von 2021 finished September 30, 2021.

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"We continue to work diligently to respond to global vaccine demands with a commitment kommen sie ensure equitable vaccine access. Our robust clinical and regulatory strategy has led to recent approvals that expand access to additional age groups, highlighted von the zuerst EUA zum a covid19 vaccine an children 5 to under 12 years von age in the united States, and authorizations zum booster doses zum multiple populations,” claimed Ugur Sahin,M.D., CEO andCo-Founder of BioNTech. "We also had a strong quarter through regard zu our oncology pipeline. Our approach kommen sie oncology addresses every patient’s unique needs by leveraging lot of therapeutic platforms with combination potential. With ns recent dosing des the first patient with autogene cevumeran bei high-risk colorectal cancer patients after adjuvant treatment, we now schutz four programs bei Phase 2 development, as our pipeline breakthroughs into later-stage trials. We space reporting optimistic clinical charme across 6 des our oncology program at die upcoming SITC conference, consisting of favorable safety and security profiles and robust immune responses.”

Third Quarter2021 und SubsequentUpdates

Infectious disease

Infectious disease ist a expansion pillar zum BioNTech, und the company ist developing vaccine candidates to address many pathogens the pose significant globalen public wellness challenges.

COVID-19 Vaccine regime – BNT162b2 BNT162b2 clinical advance updates

Multiple clinical trials space ongoing zu expand covid19 vaccine reach und explore booster doses kommen sie address waning immunity. Clinical charme to date support a der dritte tag dose booster von the vaccine in adults kommen sie augment vaccine defense over time. A der dritte tag booster dose von BNT162b2 confers high neutralizing antibody titers against SARS-CoV-2 ancestral virus und the Beta and Delta variants. The titers following a booster sheep are greater than ns levels observed after ns two-dose primary series. Additionally, studies are underway assessing variant-specific versions des the vaccine to generate data to inform BioNTech und Pfizer’s strategy to address emerging SARS-CoV-2 variants. While zu date, there is no clinical dünn suggesting the need weil das a variant-specific version of the vaccine, ns companies are establishing a preemptive prototype approach zu evaluate the development, manufacturing und regulatory processes zum variant certain vaccines. This prototype approach is aimed zu be substantiated by broad clinical säule that are being prepared weil das submission zu regulatory authorities.

In ehrenvoll 2021, BioNTech and Pfizer began a clinical trial kommen sie evaluate ns safety und immunogenicity des variant-encoding vaccine candidates, consisting of a multivalent vaccine versus two variants of concern. Ns study will enroll roughly 1,200 adults 18 kommen sie 85 years von age. Participants will receive a dritter 30 µg dose des a multivalent Delta and Alpha version des the vaccine, or monovalent Delta or Alpha versions administered sechs months after the second dose of the two-dose primary series des BNT162b2. Vaccine- und SARS-CoV-2-naïve participants an the study will receive 2 doses des the multivalent Delta und Alpha vaccine administered 21 days apart. First säule from this study space anticipated in the fourth quarter of 2021.On september 6, 2021, BioNTech und Pfizer announced dünn from a bühne 3 safety and immunogenicity clinical trial von 306 entrants 18 zu 55 years des age who received a booster sheep approximately six months after ~ completing the two-dose main regimen, with a mean follow-up time des 2.6 months post-third dose. The booster dose elicited significantly greater SARS-CoV-2 neutralizing antibody titers against the ancestral strain contrasted to ns levels observed after die two-dose primary series with titers against ancestral virologe more than 5 times as high weist 1 month after ns third dose compared zu 1 month after die two-dose major series. Ns safety profile was favorable und similar to the safety file after sheep two of the primary series und generally continuous with other clinical säule for BNT162b2. Previously reported phase 1 dünn showed a comparable pattern von third dose responses against die ancestral strain, Beta und Delta variants. Based on these säule a der dritte tag dose booster von BNT162b2 for notfall use in certain population groups was authorized von the U.S. Food and Drug administration (FDA) und the Conditional Marketing Authorization (CMA) bei the European gewerkschaftler was updated top top approval from the European commission (EC) adhering to a optimistic opinion from die European Medicines agency (EMA) weil das a booster dose of the covid19 vaccine native BioNTech und Pfizer. The data are also being submitted zu other regulatory authorities worldwide.On september 20, 2021, BioNTech and Pfizer announced confident topline results from a phase 2/3 trial an children demonstrating solid immune an answer one month after die second dose bei 2,268 children aged 5 zu under 12 years. Ns vaccine showed a favorable security profile and robust neutralizing antibody responses an this cohort making use of a two-dose regimen von 10 µg administered 21 job apart. Antibody responses to be comparable to those an a vault study bei people 16 kommen sie 25 years von age immunized through 30 µg doses. One month after die second dose, the geometric median ratio of SARS-CoV-2 neutralizing titers an the youngsters aged 5 to under 12 years kommen sie those in people 16 to 25 years of age was 1.04, meeting ns predefined immunobridging success criteria. These data compare immune responses bolzen a vaccine candidate and bei approved vaccine. These dünn were freshly submitted zum publication in a peer-reviewed journal.Subsequently, top top October 26, 2021, the companies reported further results indigenous the schritt 2/3 trial bei children the included bei additional 2,379 children, from die supplemental security group, bringing ns total zu approximately 4,500. In this analysis, BNT162b2 showed a favorable security profile, durable immune responses and also a vaccine efficacy rate of 90.7% an participants there is no prior SARS-CoV-2 infection, measured 7 work after ns second dose, during a period when Delta was die prevalent strain. Topline readouts for the various other two age cohorts from ns trial – kids 2 to On October 21, 2021, BioNTech and Pfizer announced topline outcomes from a phase 3 clinical trial to evaluate die safety, tolerability und efficacy of a 30 µg booster dose versus placebo bei more 보다 10,000 participants aged 16 years and older who formerly received two doses von BNT162b2 weist least six months prior kommen sie randomization. These erste results from a randomized, controlled covid-19 vaccine booster sheep trial demonstrated that a booster dose revitalized vaccine defense to ns high levels accomplished after the second dose, reflecting a relative vaccine efficacy von 95.6% compared kommen sie those who did notfall receive a booster dose. Many subgroup analyses verified efficacy was consistent irrespective des age, sex, race, ethnicity und co-morbidities. The adverse event profile was consistent with previous clinical safety data. Ns companies plan to share these dünn with ns FDA, EMA, und other regulation agencies and submit detailed results weil das publication bei a peer-reviewed journal.A global Phase 2/3 trial kommen sie evaluate die safety, tolerability und immunogenicity des BNT162b2 an preventing COVID-19 in healthy pregnant women 18 years of age and older ist ongoing. Ns study will deshalb assess safety in infants of vaccinated pregnant women und the transfer of potentially protective antibodies to their infants.

Regulatory updates

BioNTech und Pfizer have made progress on ns regulatory front, consisting of Biologics license Application (BLA) approval bei the united States, as well as U.S. Emergency Use Authorization (EUA) zum booster doses zum many populations hinweisen high risk of severe COVID-19-disease. The EMA authorize a confident opinion on die administration von BNT162b2 as a booster dose an adults und as a dritter dose in immunocompromised people.

In august 2021, ns U.S. FDA and the EMA authorized the extension of the shelf-life des the covid19 vaccine from sechs to ripe months wie man stored punkt -90 kommen sie -60 degrees C.On ehrenvoll 23, 2021, die U.S. FDA approved the BLA zum BNT162b2 to prevent COVID-19 bei individuals 16 years des age und older based upon a comprehensive data package that consisted of longer-term follow-up säule from the phase 3 trial. BNT162b2 zu sein the first covid-19 vaccine to be granted full approval by the FDA.On september 22, 2021, die U.S. FDA authorized a dritter dose booster for emergency use in individuals 65 years of age and older, people 18 v 64 years von age weist high risk des severe COVID-19, und individuals 18 through 64 years of age whose regular institutional or occupational exposure zu SARS-CoV-2 puts them punkt high risk of serious symptom from covid-19 including severe COVID-19. The booster dose, which is the same formulation and dosage as used bei the main series, zu sein to it is in administered at least sechs months after completion of the primary series. A dritter dose was authorized on ehrenvoll 12, 2021, under die EUA for administration zu individuals weist least 12 years des age who have undergone solid body organ transplantation, or who room diagnosed with problems that room considered to have bei equivalent level des immunocompromise.On October 5, 2021, ns EC granted a sport to die CMA zum the administration of a dritter dose booster of BNT162b2 weist least sechs months after ns second dose in individuals 18?years von age and older. This followed a positive opinion from the Committee for Medicinal Products zum Human usage (CHMP) von the EMA. The positive opinion follows die companies’ submission des a variation to the EMA requesting to update ns CMA with charme supporting a booster dose to prevent COVID-19 an individuals 16 years des age und older. The CHMP also recommended that world with severely dilute immune systems should be provided a third dose des the vaccine hinweisen least 28 job after their second dose.In October 2021, BioNTech and Pfizer announced the submission of charme supporting ns vaccination des children 5 zu under 12 years des age to ns EMA zum a variation of the CMA in the european Union. Die variation inquiry includes charme from the phase 2/3 study, which is enrolling children 6 months zu under 12 years von 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 covid19 vaccine in children periods 5 v 11 years of age based on dünn from a schritt 2/3 randomized, controlled trial. This EUA follows the FDA’s Vaccines and Related organic Products Advisory Committee (VRBPAC) poll on October 26, 2021, recommending that the FDA approve EUA bei this population.In november 2021, the EC authorized a new formulation des BNT162b2, that further simplifies vaccine handling. This decision adhered to a hopeful opinion from ns EMA CHMP. The neu formulation so allows weil das longer storage, as vials can be stored zum 10 weeks at refrigerator temperatures from 2°C zu 8°C, und after erste puncture, kann sein be stored und transported hinweisen 2°C to 30°C und used in ~ 12 hours.

Commercial updates

BioNTech and Pfizer oase delivered in aggregate of over 2 billion doses von BNT162b2 vaccine zu more than 152 countries and territories around the world as of november 2, 2021.Further discussions weil das additional sheep commitments are ongoing zum 2022 und beyond.

On september 22, 2021, BioNTech and Pfizer announced plans kommen sie expand ns existing agreement with die U.S. Government by providing in additional 500 million doses at a not-for-profit price weil das donation zu low- and lower-middle-income countries und the institutions that assistance them. This expanded agreement brings die total number von doses zu be offered to ns U.S. Government zum donation zu one billion. Ns companies are committed kommen sie working towards equitable and affordable accessibility to covid19 vaccines zum all people around ns world, proactively working v governments and health partners worldwide, und have pledged kommen sie provide two billion doses to low- und middle-income countries an 2021 and 2022.In October 2021, the Japanese government agreed kommen sie purchase one more 120 million sheep starting in January 2022, bringing ns total number of doses purchased to 314 million.On October 28, 2021, BioNTech und Pfizer announced that die U.S. Government purchased in additional 50 million doses kommen sie continue to support preparedness zum pediatric vaccinations, consisting of securing vaccines zum children under 5 years von age. V this purchase, ns U.S. Federal government has worked out its final purchase option under the existing it is provided agreement, bringing ns total number of doses secured under die agreement to 600 million, excluding die one exchange rate doses to be supplied at a not-for-profit price zum donation.

Manufacturing Updates

BioNTech und Pfizer expect kommen sie manufacture 2.7 billion kommen sie 3 billion doses von the end of 2021 and anticipate capacity to manufacture up kommen sie four billion doses an 2022. Die companies oase developed a global covid19 vaccine it is provided chain and manufacturing network, which jetzt spans 4 continents und includes more than 20 manufacturing facilities.

On august 26, 2021, BioNTech und Pfizer announced die signing des a letter of intent with Eurofarma Laboratórios SA, a Brazilian biopharmaceutical company, to manufacture vaccine zum distribution in ~ Latin America. Eurofarma möchte obtain drug product native facilities bei the united States, und manufacturing von finished doses ist expected kommen sie commence in 2022. Weist full work capacity, annual production zu sein expected kommen sie exceed 100 million finished covid19 doses.

Influenza Vaccine Program

BNT161 – On september 27, 2021, the first participants to be dosed an a phase 1 clinical trial kommen sie evaluate die safety, tolerability and immunogenicity des a single dose quadrivalent mRNA vaccine (BNT161) versus influenza in healthy adults 65 kommen sie 85 years of age, with in FDA-approved standard quadrivalent influenza vaccine together a control. BNT161 encodes welt Health company recommended strains. Dünn from die trial ist expected in the zuerst half of 2022. BNT161 ist partnered through Pfizer.

Other infectious Disease

BioNTech ist committed to developing vaccines und sustainable end-to-end vaccine production on the African continent and to provide affordable access zu low- and lower-middle-income countries. The company has ongoing its efforts to establish die necessary infrastructure und to thrive its infectious condition pipeline.

On July 26, 2021, BioNTech announced plans zu develop sustainable solutions kommen sie address transmittable diseases on ns African continent. BioNTech aims zu develop in mRNA-based malaria vaccine and the initiation von a clinical trial zu sein expected von end von 2022. On October 26, 2021, BioNTech announced that construction von the zuerst mRNA production facility in Africa zu sein expected zu begin in mid-2022, following the signing des a Memorandum of Understanding with die Rwandan government and the institut Pasteur de Dakar (Senegal). BioNTech believes this facility could end up being the erste node an a decentralized und robust afri end-to-end production network with in expected annual manufacturing capacity von several hundreds von million mRNA vaccine doses zu provide sustainable vaccine it is provided on ns African continent.The company also announced the clinical trials zum its zuerst tuberculosis vaccine candidate room planned kommen sie begin by end von 2022, just two years after die program was initiated. BioNTech has actually collaborated with ns Bill und Melinda Gates foundation since 2019 to develop preclinical vaccine und immunotherapy candidates kommen sie prevent HIV and tuberculosis infection.

Oncology

BioNTech ist advancing the development von a vast oncology pipeline, i beg your pardon spans many anti-tumor und immune-modulating approaches. BioNTech’s clinical pipeline jetzt includes randomized bühne 2 clinical trials for FixVac programs, BNT111 and BNT113, and for iNeST product candidate autogene cevumeran (BNT122, RO7198457), bringing die company’s clinical programs zu a gesamt of fünfzehn product candidates an 19 recurring clinical trials consisting of four phase 2 randomized clinical trials. BioNTech expects kommen sie further advancement its oncology pipeline in the fourth quarter des 2021 v one preclinical program expected to move into a first-in-human schritt 1 trial.Seven to update (from 6 oncology programs) with hopeful clinical und preclinical data supporting BioNTech’s oncology pipeline möchte be gift at ns Society zum Immunotherapy des Cancer’s (SITC) 36th yearly Meeting i beg your pardon takes ar on november 10–14, 2021. The information below regarding die SITC presentations mirrors data bei submitted abstracts and supplemental data may be gift at ns conference.

mRNA programsFixVac

These product candidates leverage die company"s proprietary pharmacologically optimized uridine mRNA und its proprietary intravenous lipoplex formulation.

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On september 15, 2021, ns U.S. FDA granted Orphan drug Designation kommen sie BNT111 for the treatment of Stage IIB through IV melanoma. At SITC, BioNTech intends kommen sie present additional charme from the ongoing schritt 1 trial evaluating ns safety and tolerability von BNT111 in patients with progressed melanoma. Charme demonstrated that the immunogenicity and safety profile of BNT111 together a monotherapy to be comparable an patients grouped as having actually evidence von disease (ED) and bei patients with no evidence des disease (NED). As des May 24, 2021, 14 von 22 (64%) patients through ED and 19 des 28 (68%) patients with NED demonstrated BNT111-induced T-cell responses against at least one tumor-associated antigen (TAA). An NED patients, clinical efficacy was promising with typical disease-free survival von 34.8 months.

BNT112 – hinweisen SITC, BioNTech intends zu present säule from die ongoing phase 1/2 trial des BNT112 as a monotherapy and in combination with cemiplimab in patients v metastatic castration-resistant prostate cancer (mCRPC) and newly diagnosed high-risk localized prostate cancer (LPC). Overall, as von June 22, 2021, the data suggest that BNT112 together monotherapy and in combination with a PD-1 inhibitor (cemiplimab) is well-tolerated bei mCRPC. Additionally, dünn suggest that BNT112 induces durable immune responses, as dach novo induction und expansion von pre-existing antigen-specific T-cell responses was observed an all patients with easily accessible Post-IVS-ELISpot. BNT113 – A randomized phase 2 trial analyzing BNT113 an combination with pembrolizumab matches pembrolizumab monotherapy together a first-line treatment in patients v unresectable recurrent or metastatic HPV16+ head und neck squamous cell carcinoma (HNSCC) to express PD-L1 zu sein ongoing.

Individualized neoantigen certain immunotherapy (iNeST)

Autogene Cevumeran (BNT122) – BioNTech’s iNeST product candidate autogene cevumeran is also based on ns company"s proprietary pharmacologically optimized uridine mRNA und its proprietary intravenous lipoplex formulation, and is partnered with Genentech. In October 2021, BioNTech announced the the zuerst patient was dosed bei a randomized schritt 2 trial an the adjuvant treatment of circulating tumor DNA (ctDNA) positive, surgically resected Stage ii (high-risk)/Stage III colorectal cancer. Die trial plans to enroll about 200 patients zu evaluate the efficacy of autogene cevumeran compared zu watchful waiting after surgery and chemotherapy, die current standard von care zum these high-risk patients. The primary endpoint weil das the study is disease-free survival. An additional objectives include as whole survival and safety. Die trial has been initiated in the united States, Germany, Spain and Belgium.

The clinical need weil das novel therapies to treat colorectal cancer, the second deadliest cancer worldwide, stays high. Ns current standard of care bei this indication zu sein watchful wait to see if tumors recur after removal von the main tumor und adjuvant chemotherapy. A proportion von these patients are expected to schutz a recurrence von their tumor in ~ 2 to 3 years after your surgery. For this clinical trial, patients weist high risk for recurrence möchte be selected über means of a very sensitive blood prüfung detecting ctDNA.

RiboMabs

BioNTech’s RiboMab product candidates, BNT141 und BNT142, space designed to encode secreted antibodies. These product candidates leverage ns company’s proprietary nucleoside-modified mRNA which ist designed to minimize the immunomodulatory activity des the mRNA.

BNT141 – BioNTech plans to anfang a phase 1 clinical trial weil das BNT141 in the 4th quarter von 2021. BNT142 – BioNTech jetzt plans to start a schritt 1 clinical trial weil das BNT142 bei the first half des 2022.

AntibodiesNext-generation checkpoint immunomodulators

BNT311 und BNT312 room partnered with Genmab together part des a 50/50 collaboration bei which advancement costs and future profit room shared.

BNT311/GEN1046 – A schritt 1/2 trial through multiple development cohorts in patients through solid tumors is ongoing.

At SITC, BioNTech intends kommen sie present exploratory pharmacodynamic analyses and potential biomarkers von response in in expansion cohort of patients through metastatic or unresectable NSCLC who had multiple lines of prior systemic therapy, including a checkpoint inhibitor. As of May 2021, 40 patients were enrolled und BNT311 elicited pharmacodynamic effects consistent with its suggest mechanism des action. Bei addition, relationships between disease control and PD-L1 tumoral expression, and also time from tonnage prior anti-PD-1 therapy were observed.A phase 2 trial des BNT311 together monotherapy and in combination with pembrolizumab in patients with recurrent/refractory metastatic non-small cell lung cancer is planned kommen sie start bei the fourth quarter des 2022.

BNT312/GEN1042 – A phase 1/2 trial v multiple growth cohorts bei patients v solid tumors is ongoing.

At SITC, BioNTech intends zu report, an a mini-oral presentation, clinical dünn from die dose escalation part von the ongoing phase 1/2 trial. All at once the charme demonstrated a favorable safety and security profile bei patients with advanced solid tumors, as well as biologic and early antitumor activity. As von June 11, 2021, an illness control was achieved in 25 des 49 (51%) patients, consisting of two evidenced partial responses per RECIST1.1 bei melanoma und neuroendocrine lung cancer.

Cell therapiesCAR-T cell immunotherapy

BNT211 – A first-in-human schritt 1/2 open-label dose escalation und dose development trial evaluating BNT211 in patients with Claudin-6-positive solid tumors is ongoing.

At SITC, BioNTech intends to present säule from this trial. Overall, as des July 23, 2021, Claudin-6 CAR-T cells dosed as monotherapy and bei combination with Claudin-6 CARVac verified a favorable security profile weist doses tested with encouraging signs of efficacy. Weist the zuerst tumor assessment sechs weeks ~ adoptive T-cell lieferung for ns five evaluable patients, 4 patients showed stable condition (SD) und one patient showed progressive disease (PD). 3 patients showed initial tumor shrinkage von RECIST1.1.

Neoantigen-targeting T-cell therapy

BNT221 – A first-in-human phase 1 dose escalation trial evaluating BNT221 bei patients v checkpoint inhibitor unresponsive or refractory metastatic melanoma ist ongoing. Weist SITC, preclinical data demonstrating NEOSTIM"s ability to induce CD8+ and CD4+ T-cell responses utilizing peripheral blood mononuclear cell from patients v ovarian cancer möchte be presented. This responses were polyfunctional, specific and have the capacity kommen sie degranulate. 

Small molecule immunomodulatorsToll-like receptor binding agonist

BNT411 – A bühne 1/2 dose-escalation trial des BNT411 together a monotherapy an patients through solid tumors and bei combination through atezolizumab, carboplatin und etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC) is ongoing.

At SITC, BioNTech intends to present preliminary clinical charme from the schritt 1/2 trial. Overall, as des July 1, 2021, BNT411 demonstrated bei acceptable safety and security profile punkt all sheep tested as a monotherapy and an combination with atezolizumab, carboplatin and etoposide. Pharmacodynamic signals to be encouraging and showed a strong induction of type 1 interferon-dominated cytokines an line with the proposed mechanism of action. BNT411 has bezeichnen early signal von prolonging stable an illness even an heavily pre-treated patients including post-anti-PD-1. Both pharmacodynamics and anti-tumor responses warrant additional expansion an various indications either together a monotherapy or in combination with various other standard-of-care treatments.

Corporate Updates

In October 2021, BioNTech expanded its infectious condition portfolio capabilities by acquiring PhagoMed Biopharma GmbH, bei Austrian biotechnology company, specialized an the development des a new class of antibacterials.

Third quarter 2021 gaue won Results

Revenues: pistole revenues were estimated kommen sie be €6,087.3 million1 for die three months finished September 30, 2021, compared kommen sie €67.5 million weil das the three months finished September 30, 2020. Weil das the nine months finished September 30, 2021, pistole revenues were estimated to be €13,444.2 million1 compared zu €136.9 million zum the comparative former year period. The increase was mainly due kommen sie rapid increases in the supply und sales von the covid19 vaccine worldwide. Under the collaboration agreements, territories oase been allocated between BioNTech, Pfizer und Fosun Pharma based on marketing and distribution rights. During the three months finished September 30, 2021, BioNTech’s commercial profits included bei estimated amount von €4,341.5 million1 gross benefit share and €17.0 million des sales milestones. During ns nine months ended September 30, 2021, BioNTech’s commercial profits included in estimated amount von €9,769.9 million1 gross profit share and €432.8 million von sales milestones. BioNTech’s share des the cooperation partners’ gross profit ist based on covid19 vaccine sales in Pfizer’s und Fosun Pharma’s territories und represents a net figure. In addition, during ns three und nine months finished September 30, 2021, respectively, €312.3 million und €514.3 million sales kommen sie BioNTech’s teamwork partners of products manufactured von BioNTech and €1,350.8 million and €2,586.2 million direct covid19 vaccine sales zu 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 die three months ended September 30, 2021, compared zu €6.8 million weil das the three months finished September 30, 2020. Weil das the nine months finished September 30, 2021, cost von sales were estimated kommen sie be €2,328.3 million1, compared kommen sie €18.3 million for the comparative former year period. During the three und nine months finished September 30, 2021, approximated cost des sales von €1,194.8 million1 and €2,290.1 million1, respectively, were well-known with respect kommen sie BioNTech’s covid19 vaccine sales and include the share von gross profit the BioNTech fan its collaboration kollege Pfizer based upon its sales.

Research and Development Expenses: Research and development prices were €260.4 million zum the three months ended September 30, 2021, compared to €227.7 million zum the 3 months ended September 30, 2020. For the nine months ended September 30, 2021, research and development costs were €677.7 million, compared to €388.0 million for the comparative front year period. Ns increase was mainly early out to an increase bei research und development costs from die BNT162 program. The increase was further thrust by an increase an wages, benefits and social security costs following in increase bei headcount, die recognition of inventor compensation expenses as well as expenses incurred under share-based-payment arrangements.

General and Administrative Expenses: General und administrative prices were €68.2 million zum the 3 months finished September 30, 2021, compared kommen sie €23.5 million zum the 3 months ended September 30, 2020. Weil das the nine months finished September 30, 2021, general and administrative prices were €154.9 million, compared to €58.1 million for the comparative prior year period. Die increase was mainly early out to an increase in wages, benefits and social security prices following bei increase in headcount und expenses occurs under die share-based-payment arrangements, enhanced expenses zum purchased monitoring consulting and legal service as fine as higher insurance premiums caused von the increased unternehmen volume.

Income Taxes: Interim earnings taxes were accrued in an amount des €1,456.4 million and €3,206.2 million zum the three und nine months finished September 30, 2021, respectively, und were recognized using die estimated yearly effective revenue tax rate des approximately 31%.Net Profit/(Loss): net profit was €3,211.0 million weil das the 3 months ended September 30, 2021, compared kommen sie €210.0 million net loss zum the three months finished September 30, 2020. Weil das the ripe months finished September 30, 2021, network profit was €7,126.3 million, compared kommen sie €351.7 million net loss zum the comparative prior year period.

Cash Position: Cash und cash equivalents as of September 30, 2021 were €2,392.7 million. In addition, profession receivables remained superior which ist mainly due to die contractual settlement of the gross profit share under the covid-19 collaboration through Pfizer, which has actually a temporal offset des more 보다 one calendar quarter. Together Pfizer’s budget quarter for subsidiaries outside die United states differs native BioNTech’s financial reporting cycle, it creates in additional time lag bolzen the recognition des revenues and the payment receipt. Consequently, these trade receivables which room subject zu this temporal offset und were outstanding as of September 30, 2021 were obtained as payments bei October 2021, enhancing BioNTech’s cash position.

Shares Outstanding: Shares superior as von September 30, 2021 to be 242,516,955.

Updated Outlook zum the 2021 gaue won YearUpdate on covid19 Vaccine plan Deliveries zum the 2021 gaue won Year:

Estimated BioNTech COMIRNATY/COVID-19 vaccine revenues zum the complete 2021 jae won year based upon up kommen sie 2.5 billion doses: ~€16 billion zu €17 billion2
This revenue calculation reflects:Expected revenues from direct covid19 vaccine sales kommen sie customers in BioNTech’s territoryExpected profits from sales to collaboration partners von products manufactured by BioNTechExpected sales milestone payments from teamwork partnersExpected revenues related kommen sie share of gross profit from covid19 vaccine sales in the participation partners’ territories

Planned 2021 financial Year Expenses and Capex2:

Previous price guidance maintained for the full 2021 financial year
R&D costs €950 million - €1,050 million
SG&A expenses €250 million - €300 million
funding expenditures €175 million - €225 million
Further ramp-up von R&D investment in Q4 2021 planned zu expand and accelerate the pipeline development
Ranges reflect current base case projections

Estimated 2021 financial Year taxes Assumptions:

BioNTech group estimated annual effective revenue tax rate: ~31%

The complete interim unaudited condensed consolidated financial statements can be found in BioNTech’s Report on form 6-K, filed heute with ns SEC und available hinweisen https://www.sec.gov/.1Estimated figures based on preliminary charme shared betwee the collaboration partner and BioNTech as completely described bei the annual Report on form 20-F too as the Quarterly Report together of und for die Three und Nine month Ended september 30, 2021, filed as in exhibit zu BioNTech’s current Report on form 6-K. Changes in the share von the teamwork partners’ gun profit will be recognized prospectively.2Figures oase been estimated hinweisen constant foreign exchange rates.

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About BioNTechBiopharmaceutical new Technologies zu sein a following generation immunotherapy agency pioneering novel therapies for cancer und other serious diseases. The Company exploits a wide array des computational discovery und therapeutic drug platforms for the quick development von novel biopharmaceuticals. Its broad portfolio of oncology product candidates has individualized und off-the-shelf mRNA-based therapies, fix up chimeric antigen receptor t cells, bispecific checkpoint immuno-modulators, target cancer antibodies and small molecules. Based upon its deep expertise an mRNA vaccine development und in-house production capabilities, BioNTech and its partners are arising multiple mRNA vaccine candidates weil das a range of infectious diseases alongside its varied oncology pipeline. BioNTech has established a large set von relationships with multiple globalen pharmaceutical collaborators, consisting of Genmab, Sanofi, bayer Animal Health, Genentech, a member von the Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer.

For an ext information, you re welcome visit www.BioNTech.de

Investor RelationsSylke Maas, Ph.D. VP Investor connections & strategy Tel: +49 (0)6131 9084 1074 E-mail: Investors
biontech.de 

Media RelationsJasmina AlatovicSenior manager 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 finished September 30, Nine months ended September 30,
2021202020212020
(in millions, except von share data) (unaudited)(unaudited)(unaudited)(unaudited)
earnings
research study & advance revenues €47.2 €59.7 €96.1 €113.4
Commercial earnings 6,040.1 7.8 13,348.1 23.5
Total revenues €6,087.3€67.5€13,444.2€136.9
Cost von sales (1,211.4) (6.8) (2,328.3) (18.3)
Research und development expenses (260.4) (227.7) (677.7) (388.0)
Sales und marketing costs (10.5) (4.3) (32.5) (7.8)
General und administrative expenses (68.2) (23.5) (154.9) (58.1)
other operating prices (26.4) (0.4) (27.3) (1.3)
various other operating income 213.1 8.8 360.6 10.0
Operating revenue / (loss) €4,723.5€(186.4)€10,584.1€(326.6)
Finance income 26.6 0.5 51.4 1.1
Finance costs (81.9) (21.1) (301.0) (24.5)
Interest costs related zu lease legal responsibility (0.8) (0.5) (2.0) (1.4)
Profit / (loss) prior to tax €4,667.4€(207.5)€10,332.5€(351.4)
revenue taxes (1,456.4) (2.5) (3,206.2) (0.3)
Profit / (loss) zum the period €3,211.0€(210.0)€7,126.3€(351.7)
Earnings von share
basic profit / (loss) zum the period von share €13.14 €(0.88) €29.22 €(1.51)
Diluted profit / (loss) for the period von share €12.35 €(0.88) €27.46 €(1.51)

Interim Condensed Consolidated Statements von Financial Position

September 30, December 31,
(in millions) 20212020
Assets (unaudited)
Non-current heritage
Intangible assets €162.9 €163.5
Property, plant and equipment 294.4 227.0
Right-of-use heritage 147.7 99.0
other assets 0.9 1.0
Deferred taxation assets 75.3 161.2
Total non-current heritage €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
earnings tax legacy 0.9 0.9
Deferred prices 49.4 28.0
Cash und cash equivalents 2,392.7 1,210.2
Total existing 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)
various other reserves 77.9 25.4
Total same €8,711.5€1,371.8
Non-current liabilities
Interest-bearing loans and borrowings 267.7 231.0
other financial legal responsibility 324.9 31.5
Provisions 5.7 5.5
Contract legal responsibility 10.5 71.9
other liabilities 9.7 0.6
Deferred taxes liabilities 0.3
Total non-current liabilities €618.5€340.8
Current legal responsibility
Interest-bearing loans and borrowings 19.0 9.1
trade payables 258.9 102.3
other financial legal responsibility 924.5 74.1
government grants 3.1 92.0
revenue tax liabilities 3,118.4
Provisions 189.7 0.9
Contract legal responsibility 284.2 299.6
various other liabilities 104.8 28.0
Total present 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 finished September 30, Nine months finished September 30,
2021202020212020
(in millions) (unaudited)(unaudited)(unaudited)(unaudited)
Operating activities
profit / (loss) zum the duration €3,211.0 €(210.0) €7,126.3 €(351.7)
revenue 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 benefit / (loss) before tax zu net cash flows:
Depreciation und amortization von property, plant, equipment and intangible assets 19.8 8.8 49.2 26.2
Share-based payment cost 23.1 8.1 62.4 24.8
network foreign exchange differences (194.2) 0.1 (295.5)
acquire on disposal des property, plant and equipment 0.6 0.4 0.7
Finance earnings (0.6) (0.5) (1.2) (1.1)
attention 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 earnings 24.9 24.9 (0.2)
Working funding adjustments:
Increase bei trade and other receivables, contract assets und other legacy (3,343.9) (45.1) (10,095.4) (54.9)
Increase an inventories (88.0) (3.7) (329.3) (0.5)
Increase in trade payables, various other financial liabilities, other liabilities, contract liabilities und provisions 332.9 47.8 1,153.9 94.5
Interest got 0.4 0.2 1.0 0.8
interest paid (2.2) (0.6) (6.1) (1.6)
income tax got / (paid), network (0.7) 0.2 (1.0) (0.2)
Net cash operation from / (used in) operation 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 von property, plant und equipment 0.2 1.4
Purchase des intangibles assets und right-of-use assets (0.8) (1.0) (12.5) (5.2)
Acquisition of subsidiaries and businesses, net of cash obtained 0.9
Net cash flows used an investing activities €(41.1)€(20.3)€(99.2)€(45.0)
Financing activities
Proceeds from issuance von share capital and treasury shares, net des costs 532.3 160.9 680.1
Proceeds from loans and borrowings 99.5 102.4
Repayment des loans und borrowings (0.5) (0.6) (1.9) (0.9)
payment related zu lease liabilities (4.8) (1.0) (15.9) (3.2)
Net cash operation from / (used in) financing activities €(5.3)€630.2€143.1€778.4
net increase bei 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 ns beginning von the period 914.1 573.0 1,210.2 519.1
Cash und cash equivalents at september 30 €2,392.7€990.5€2,392.7€990.5