Thank you for standing by, and welcome to BioNTech 's Third Quarter 2021 update call. At this time, all participants are in listen-only mode. [Operator Instructions]. We would like to ask to please limit yourself to one question per person.

I must advise you this call is being recorded today, Tuesday November 9, 2021, and I would now like to hand the meeting over to the Vice President, Investor Relations and Strategy, Sylke Maas. Please go ahead..

Good morning and good afternoon. Thank you for joining us today to review BioNTech's Third Quarter 2021 operational brokers and financial results.

Before we start, we encourage you to view the slides for this webcast, as well as the operation and financial results [Indiscernible] to these issues this morning, both of which are accessible in our website in our Investment section. As shown on Slide 2, during today's presentation, we will be making several forward-looking statements.

These forward-looking statements include, but are not limited to our current estimated COVID-19 vaccine revenues based on current contracted supply orders, particularly for those figures that are derived from preliminary estimates provided by our partners or estimated financial results for 2021, our continued global demand for our COVID-19 vaccine, our target vaccine production capacity for 2021 and beyond, our ability to supply our COVID-19 vaccine.

The plans [Indiscernible] steps in our pipeline programs, the timing for enrollment, initiation, completion, and reporting of data from our clinical trials and other risks described in our filings made [Indiscernible] to the U.S. Securities and Exchange Commission, including almost recent annual report on form 20-F.

Accurate results could differ from those we currently anticipate. You are therefore cautioned not to place undue reliance on any forward-looking statements which speak only as of today, shed today during this conference call and webcast.

Also, please note that Slide 3 and 4 provide detailed and important safety information regarding our COVID-19 vaccine. Slide 5 is our agenda for our call today.

I am joined today by our CEO and Co-Founder, Ugur Sahin, Ozlem Tureci, our Chief Medical Officer and Co-founder, Sean Marett, our Chief Business and Commercial Officer, Jens Holstein, our Chief Financial Officer, Ryan Richardson, our Chief Strategy Officer, and Sierk Poetting, our Chief Operating Officer. I now turn the call over to Ugur Sahin..

Thank you Sylke. Good morning and good afternoon. And thank you to everyone joining the call today, I will walk you through the key highlights of last quarter's performance before inviting my team to go into further detail. Our strong performance continued in the third quarter in terms of commercial execution and clinical pipeline advancement.

With our partner Pfizer, we have shipped more than 2 billion doses of our COVID-19 vaccine to more than 152 countries or regions worldwide. worldwide. We continue to be humbled by the impact of our vaccine and of our Company is having in addressing the global pandemic. We still have further to go to reach many parts of the, world.

We are prioritizing equitable vaccine access to lower and middle-income countries. The first 3 quarters of 2021, we expanded our oncology pipeline faster than during any other period in our Company's history. We initiated 3 randomized Phase 2 trials and multiple research in human studies.

We will present data for 6 of our programs at the upcoming SITC conference, clearly demonstrating the focus in our cancer pipeline. Ozlem will provide detail on some of this update in her prepared remarks.

Moving to Slide 7; our strategy remains focused on bringing our both patent of next-generation immunotherapies and vaccines to patients worldwide to address cancer and a growing list infectious disease. The transformation of BioNTech into a global fully integrated Immunotherapy powerhouse is continuing at rapid pace. We are adding talent to our team.

We are expanding our capabilities and geographic presence. We are increasing our investment in automation, digitalization, and AI technology. Our vision is to build a Heart technology Company of the coming age. We are developing an exciting innovation at the intersection of immunology and synthetic biology.

We believe our innovations can make a profound difference for people around the world and we remain committed to investing in the Company to the deliver on this vision in the years to come. Slide 8.

We are driving innovations across multiple therapeutic platforms to harness the power of the immune system and to transform treatment paradigm in infectious disease and solid tumors. The last 18 months have demonstrated the power, flexibility, and the speed of our mRNA vaccine technology.

We have established a proven path to regulatory approval for our first vaccine and have created one of the largest safety data bases for pharmaceutical product. This is supported by our global manufacturing and distribution network that has capacity to provide millions of doses of vaccine supply for the world.

Behind COVID-19, they're advancing a pipeline of 10 milli vaccines and immunotherapies for diseases which caused major global half challenges, including influenza, HIV, tuberculosis, and malaria. We plan to accelerate our efforts here and aim to initiate multiple clinical products in the next 18 months.

In oncology, we are building a toolbox of technologies across a range of drug classes. We now have 15 oncology product candidates in 19 ongoing clinical trials, including 4 active Phase 2 trials. We are addressing a wide range of therapeutic targets with diverse and complimentary modes of action.

We believe that this multi-modal approach opens up new and powerful combination therapy opportunities across a broad range of solid tumor s that current standards of care remain not to be sufficient.

Finally, we believe that the broad spectrum of our technologies will enable us to bring forward new treatment approaches that have the potential to broaden the disease horizon beyond oncology and infectious disease, like autoimmune and inflammatory diseases, and even break [Indiscernible] medicine.

Slide 9 summarizes the key highlights for the third quarter. Our financial performance continues to be strong. We recorded in Q3 revenues of approximately 6 billion euros driven by the continued ramp up of COVID-19 vaccine production and delivery worldwide. Today, we are announcing a new expansion of our infectious disease toolkit.

New class of position antibacterial through the acquisition of [Indiscernible] and Austrian biotechnology Company.

The [Indiscernible] action complements our infectious disease pipeline of mRNA vaccines and mRNA encoded antibody with a new precision NPAC bacteria or technology that we believe could be useful against the global challenge of antimicrobial resistance.

In the third quarter, we initiated dosing in our randomized Phase 2 trials of autogene cevumeran or BNT122 of our iNeST candidates for the adjuvant treatment of higher risk quarter [Indiscernible] cancer patients were up positive for circulating tumor DNA.

In addition, our fixed [Indiscernible] product candidate BNT111 was recently trended to Orphan designation by the USFDA for the treatment of advanced checkpoint inhibitory that tracks away of resistant melanoma. Infectious diseases in September pilot initiated upset human study of BNT161 an influenza vaccine based on our mRNA technology.

Moving to highlight of our COVID-19 vaccine, we have now distributed a total of more than 2 billion vaccine doses globally. We expect to produce up to 3 billion doses for 2021 and expect to deliver up to 2.5 billion COVID-19 doses by the end of this year. In 2022, we expect our manufacturing capacity of up to 4 billion doses.

Our COVID-19 vaccine has now received for BLA FDA approval in the United States for the use in individuals age 16 and older. U.S. FDA has also authorized a boosting with a third dose of the vaccine for some higher risk population. In the EU, a booster dose has been approved for subjects 18 years and older.

To support the extension of the vaccine label to include children age 5 to under 12, a clinical data package has been submitted to regulators around the globe. The FDA has recently granted Emergency Use Authorization of BNT162B2 in children age 5 to under 12, and the US government purchased an additional 50 million pediatric doses.

I feel humbled about our team's continued exceptional work and would like to close my remarks by emphasizing that even as BioNTech is transforming, we will continue to stay true to our vision and remain focused on our goal to bring the next-generation immunotherapy to patients around the world.

I will now turn the call over to Sean who will provide updates on our COVID-19 program..

Thanks, Ugur. It's a pleasure to be speaking with everyone today. Turning now to Slide 11, together with our collaborators Pfizer and [Indiscernible] we have established a global development program and distribution network for our COVID-19 vaccine.

Our order book for 2021 continues to be strong with the addition of several new orders from the U.S., Japan, and other regions last quarter. Discussions with regard to additional contracts for 2022 and beyond remain ongoing. We anticipate that the additional 50 million pediatric doses ordered by the U.S.

government should be delivered by April 30th, 2022. With this order, the U.S. government exercised its final purchase option under its existing supply agreement, bringing the total number of BNT162B2 doses secured under this agreement, since the start of the pandemic to 600 million.

We continue to lead in ensuring equitable vaccine access to low- and middle-income countries. BioNTech has pledged 2 billion doses by the end of 2022 and a significant amount of our remaining 2021 million manufacturing will be allocated to equitable vaccine access. Importantly, we have expanded our agreement with the U.S.

government from 500 million to 1 billion doses at a not for profit price for 2021 and 2022. These doses are intended for donation to low and lower-middle-income countries and organizations that support them. Our hope is that by increasing vaccine access in these regions, surges in infection will be brought under control in many parts of the world.

We and our partner Pfizer are also expanding our global manufacturing capabilities with regional solutions in Africa and Latin America. This includes the letter of intent we signed with Eurofarma laboratories in Brazil to manufacture our COVID-19 vaccine.

Per the agreement, Eurofarma will obtain drug product from facilities in the United States and manufacturing of finished doses are expected to commence in 2022. At full operational capacity, the annual production is expected to exceed 100 million finished doses annually.

Additionally, we recently signed a memorandum of understanding with the Rwanda n government and Institute Pasteur de Dakar and announced plans to start the construction in mid-2022 of the first stage of the old manufacturing site for mRNA manufacturing to the African Union.

We believe this facility can become a node in a decentralized and robust African end-to-end manufacturing network to provide sustainable vaccine supply on the African continent. Establishment of this regional network is expected to enable annual manufacturing capacity of several hundreds of millions of mRNA vaccine doses.

Moving to Slide 12, I will provide an update on our strategic key leavers to explain the global reach of our vaccine. The slide provides an overview of progress across all areas, but I will only be highlighting those details which haven't already been touched on by Ugur.

Starting with our manufacturing capacity, we have worked continually with our partner Pfizer, to increase the capacity of the global supply chain and manufacturing network, which now includes more than 20 facilities across 4 continents. To expand our vaccine label and generate useful data in additional populations.

We have multiple ongoing clinical trials, which we have detailed previously, including trials in younger children and pregnant women. We are currently expecting data for children 2 to 5 years of age and children 6 months to 2 years of age in late Q4 2021 or early Q1 2022.

Ugur already highlighted our significant prices on the regulatory front and our data in children of 5 to 11 years of age, which Jocelyn will cover in detail.

We have further optimized our vaccine formulations to simplify access globally, and we recently received authorizations from both the FDA and EMA to store our vaccine for up to 9 months and -92 to -60 degrees Celsius.

Additionally, following a positive opinion from [Indiscernible] CHMP, the EC approved a new formulation of BNT162B2, that further simplifies vaccine handling and with optimized storage conditions. The vials can be stored up to 10 weeks at standard refrigeration temperatures of 2 to 8 degrees Celsius.

Our understanding of the human immune response to COVID-19 as well as emerging variants continues to evolve. And our team is continuously evaluating the [Indiscernible] data, as well as data from our own clinical studies to rapidly respond to the changing dynamics of the pandemic.

Multiple trials are ongoing to address need for boosted dose of BNT162b2. We are currently studying very specific vaccine versions.

While we don't plan to commercialize if there is a specific version of the vaccine at this time, we remain ready to adapt our technology, manufacturing and regulatory process to ensure our vaccine provides, robust protection against COVID-19.

We are very pleased with the latest clinical and regulatory developments from our vaccine, which demonstrate our strong execution in response to the COVID-19 pandemic.

I'll now turn the call over to Ozlem, who will provide details of our recent vaccine study results, as well as provide an overview of our oncology programs, including positive data to be presented at the upcoming SITC Conference..

9 patients have been treated with BNT112 monotherapy in Part 1; all with heavily pre -treated late stage cancer, heart patients were treated in Part 2. Overall, most adverse events that occurred in Part 1 were mild or moderate. There were two instances of Grade 3 hypertension, leading to dose reductions.

Both patients recovered within 24 hours and these events did not meet the criteria of dose-emitting toxicity. All reported series as worth events in Part 1 were considered unrelated to BNT112. No safety sickness or concerns were identified in Part 2 in which patients received BNT112 only or in combination with cemiplimab.

All certain patients who were ELISpot - evaluable exhibited detectable immune responses. We also confirmed that all 5 tumor-associated antigens were immunogenic and identified T cell responses to each antigen in at least 2 patients.

2 patients with late-stage cancer treated with BNT112 lunar therapy had decreases in prostate-specific antigen, the well-known prostate cancer biomark.

In summary, these data suggest that BNT122 has a total of those safety profile and enrollment to part 2 is ongoing in monotherapy, as well as in combination with semi-premium with first signal of activity in patients with advanced prostate cancer.

Slide 24, and moving to BNT211 that comprises 2 drug products, Claudin-6 CAR-T cells and the CAR-T cell amplifying RNA vaccine in short [Indiscernible] Claudin-6 CAR-T cell is equipped with the second-generation chimeric antigen receptor of high sensitivity and specificity for the tumor specific androgen Claudin-6.

Claudin-6 is absent in heavy add-on tissues, yet frequently expressed in high medical need cancer. Making this tumor antigen an ideal target for CAR T-cell therapy. Pre -clinical studies demonstrated that CARVac [Indiscernible] in [Indiscernible] expansion of transferred [Indiscernible], increasing depth assistance, and efficacy.

BNT211 is expected to overcome [Indiscernible] limitation in patients, with solid tumors. The first in-human Phase 2 dose escalation trial evaluates the safety and efficacy of Claudin-6 CAR-T cell monotherapy, and in combination with CARVac in patients with Claudin-6-positive relapsed or refractory advanced solid tumor.

Part 1 comprised Claudin-6 CAR-T monotherapy dose escalation cohorts, and Part 2 is a dose escalation of CAR-T combined with a fixed dose of CARVac. There are 3 dose level cohorts for each part. The subsequent dose expansion will focus on ovarian, testicular, and endometrial cancers, as well as other Claudin-6-positive cancers.

As of July 23rd, dose level 2 of part 1 and dose level 1 of part 2 are ongoing. On Slide 25, we show preliminary results from the Phase 1/2 BNT211 clinical trial that will be presented at [Indiscernible]. The 8 patients included in the analysis, were all heavily pre -treated with testicular ovarian, and endometrial cancer and sarcoma.

[Indiscernible] therapy. Claudin-6 CAR-T as monotherapy or combined with CARVac, were well-tolerated at the dose levels evaluated and no dose limiting toxicities were observed.

Some cases of cytokine release syndrome occurred, were manageable with no signs of neurotoxicities, increases of [Indiscernible] C-reactive [Indiscernible] were transient and moderate. Patients receiving the combination therapy had trends in flu-like symptoms that results within 24 hours.

But a net interest of cutting said frequency inventory bled off a patient, who neared robust CAR-T cells engraftment up to date 17 post infusion. Further expansion was noted in 2 patients with liver metastasis accompanied by innovators development.

There were also encouraging signs of clinical activity in patients for which a 6-week tumor assessment was available. 3 patients showed initiative tumor shrinkage, with tumor reduction between 18 % and 27 % according to RECIST. Signs of initial tumor shrinkage were identified even at the lowest dose tested.

Data on one additional patient evaluated between the extract submission and the conference will be shared during the [Indiscernible] presentation. The data from the trial are very encouraging and we look forward to presenting updated data from the open cohorts and especially for the combination part with CARVac at upcoming congresses.

Now we move to a data update of our ongoing Phase 1/2 trial on our bi-specific antibody BNT311, which we are developing in collaboration with Genmab. Slide 26 shows the mechanism of action of BNT311 and the Phase 1/2 trial design.

BNT311 is the first-in-class, bi-specific antibody designed to elicit an anti-tumor immune response by some [Indiscernible] and complementary blockade of Pds 1 on tumor cells and conditional 4-1BB stimulation on T-cell s and [Indiscernible] cells.

Previous analyses presented at SITC 2020 showed encouraging signs of clinical activity and a manageable safety profile in patients with advanced solid tumors during the dose escalation phase of this ongoing Phase 1/2 trial.

This data along with a semi-mechanistic pharmacokinetic/pharmacodynamic predictive model, and translational work established 100 milligrams of BNT311 every 3 weeks as the dose for expansion cohorts. For details on this model will be presented existing.

Since the dose escalation, we have proceeded to the dose expansion cohorts of heavily pre -treated patients with relapsed or refractory, advanced and or metastatic started tumors with preliminary data shown on Slide 27.

The safety data are in line with our previous disclosures and most treatment related adverse events were mild to moderate Immunophenotyping of peripheral blood, measurements of soluble immune mediators from [Indiscernible] blood samples, and immunohistochemistry and analysis of 2 more biopsies showed that the BNT311 elicited, pharmacodynamic effect consistent with its proposed mechanism of action.

We identified peripheral and tumor immune activity in patients, including the modulation of immune cytokine, the expansion of CD8 effect on memory [Indiscernible] pieces and [Indiscernible] activation. 5 patients had partial responses and showed a trend towards greater induction of cytokines and immune endpoints compared to non - responder.

We also identified associations between disease control and the time from last anti-PD-1 therapy prior to the study treatment and PD-1 expression on tumor. The disease control rates were higher among patients who had progressed with prior anti-PD-1 therapy within 8 months prior to the first dose of BNT311.

Tumor reduction of any degree occurred mainly in patients with PD - L1 + tumor. In finding support that patient selection and or anti-PD-1 combination therapy maybe to further improve clinical efficacy.

We expect to start a Phase 2 trial of BNT311 as monotherapy and in combination with pembrolizumab in refractory or iNeST metastatic non-small cell lung cancer within the next weeks. On Slide 28 our seconds first [Indiscernible] antibody BNT312, which we are also developing in collaboration with Genmab.

It combines targeting and conditioning activation of CD4 and 41BP on immune cells resulting in enhanced priming and activation of tumor specific immunity. Ongoing first inhuman trial evaluates the safety and anti-tumor activity of BNT312.

As shown on Slide 29, as of July 1st, 2021, 60 patients have received BNT312 monotherapy in the dose escalation part. The most common types cancer includes colorectal cancer, melanoma, and non-small cell lung cancer in patients have undergone a median of 2.5 treatment circuits.

To date, the maximum tolerated dose had not been reached and be [Indiscernible] has demonstrated a favorable safety profile with treatment-related adverse events being mostly mild-to-moderate. 1 dose-emitting toxicity of transaminase innovation occurred at the 200-milligram dose and with that, 1 corticosteroids administration.

We have observed increases in [Indiscernible] [Indiscernible] and dendritic cells cytokines, and also increased levels of CD8 and effect on memory pieces. This suggests biological activity that is consistent with the proposed, mechanism of action for the [Indiscernible].

Now over about half of these patients who had exhausted standard therapies achieved disease control. 2 patients with melanoma and neuroendocrine lung cancer who had confirmed partial responses.

We have identified 100 milligram every 3 weeks for dose expansion also for [Indiscernible] the study was recently updated to include multiple expansion cohorts, including as a front-line treatment in head and neck squamous cell carcinoma, melanoma, and pancreatic ductal adenocarcinoma.

Additional expansion cohorts will include combination with Pembrolizumab in first-line non-small cell lung cancer in combination with Pembro and chemotherapy in first-line head and neck squamous cell carcinoma.

As shown on Slide 30, at SITC we will also present data from a Phase 1/2 trial in patients with solid tumors of our toll-like receptor 7 agonist product candidate BNT411.

BNT411 is a small molecule designed to activate both the adaptive and innate immune system through the toll-like receptor 7 pathway and to stimulate antigen-specific CD8 P6, P3 and innate immune cell.

During the dose escalation part, patients was metastatic or unresectable solid tumors that have exhausted available treatments will receive BNT411 monotherapy at to 8 different dose levels, and a second dose escalation on patients with chemotherapy extensive stage small-cell lung cancer, where we keep BNT411 in combination with cytotoxic therapies and checkpoint inhibitors.

The dose escalation will be followed by a dose expansion cohort. As of July 1st 2021, 11 heavily pre -treated patients have received BNT411 one of European. That’s a type of 8 dose levels have been cleared for evaluation. To-date, BNT411 had to turn on their safety profile was no dose limiting emitting toxicities.

The only drug related adverse events reported were a non-serious [Indiscernible] and micro moderate anemia. The biological activity of BNT411 was consistent with its mechanism of action as indicated by the induction of plasma cytokines and increased levels of interferon Gamma-induced protein.

Based on preliminary unclean data, the best response seen for BNT411 monotherapy in these few patients were 5 months of stable disease in a patient with anti-PD-1 pretreated [Indiscernible].

These status support that 1 [Indiscernible] the trial into that dose escalation pop in which patients receive, BNT411 in combination with cytotoxic therapies and checkpoint inhibitors and recruitment into the therapy arm started in June. Recruitment for the expansion [Indiscernible] is expected to begin next year.

This encouraging data from our oncology programs, which we will present at [Indiscernible], 2021, are indicative of significant progress in our oncology portfolio, and they represent critical steps for us towards bringing cancer immunotherapy into the next generation.

I now turn over to our Chief Financial Officer, A - Jens Holstein, who will discuss our financial results..

Thank you, and a warm welcome to those of you on the phone. I will start my section by moving to our financial results for the third quarter of 2021 as shown on Slide 32. Total revenues were estimated to be approximately €6.1 billion for the third quarter of 2021, compared to €67.5 million for the comparative period in 2020.

For the period of 9 months ended September 30, 2021, we reported estimated total revenues of around €13.4 billion compared to €136.9 million for the comparative prior year period. Total revenues increased due to the rapid increase in supply and sales of our COVID-19 vaccine worldwide.

As a reminder, on our COVID-19 vaccine collaborations, territories have been allocated between us, Pfizer and Fosun Pharma based on marketing and distribution rev. A breakdown of our commercial revenues is shown on Slide 33.

Our third quarter 2021 commercial revenues include approximately €4.4 billion and perspectival €10.2 billion for the first 3 quarters of 2021, that comprise our cross-profit share generated by our collaboration partners in their respective territories, as well as sales milestones.

The sales milestones included in the figure just mentioned amounted to €17 million for the third quarter and €432.8 million for the period of 9 months ended September 30th, 2021.

Similar to previous quarters, the figure saw a profit share are estimated based on preliminary data shared between Pfizer and us and maybe subject to adjustment pending final data on input parameters like sales volume in values, as well as transfer pricing.

Any changes in our share of collaboration partners ' gross profit will be recognized prospectively.

Our COVID-19 vaccine commercial revenues in the third quarter also include €312.3 million in sales to our collaboration partners of products manufactured by us, and €1.4 billion of direct COVID-19 vaccine sales to customers in our territory, which includes Germany and Turkey.

For the period of 9 months ended September 30, 2021 we had sales to our collaboration partners of €514.3 million and approximately €2.6 billion direct COVID-19 vaccine sales in Germany and Turkey.

Now returning back to Slide 32 and moving to cost of sales, which were estimated to be €1.2 billion for third quarter of 2021 compared to €6.8 million for the comparative period in 2020.

For the 9 months ended September 30, 2021, total cost of sales was estimated to be around €2.3 billion, compared to €18.3 million for the comparative prior year period.

The increase was driven by cost of sales recognized with respect to our COVID-19 vaccine sales and included the share of gross profit that we owe our collaboration partner Pfizer on all sale. Research and Development expenses were €260.4 million for the third quarter of 2021 compared to €227.7 million for the comparative period in 2020.

For the 9 months ended September 30th, 2021, Research and Development expenses reached €677.7 million compared to €388 million for the comparative prior year period. The increase was mainly due to an increase in research and development expenses from the BNT162 program. As a reminder, development costs are shared equally between Pfizer and us.

The increase was further driven by an increase in wages, benefits, and social [Indiscernible] expenses following an increase in headcount, the recognition of inventory compensation expenses, as well as expenses incurred on the share-based payment arrangements from the Company.

General and administrative expenses was 68.2 million euros for third quarter of 2021 compared to 23.5 million euros for the comparative prior year period. For the 9 months ended September 30th, 2021, general and administrative expenses reached €154.9 million compared to €58.1 million for the comparative prior-year period.

Similar to R&D, the increase in G&A was driven by an increase in headcount and expenses incurred under the Company's share-based payment arrangement. Increase in expenses for purchased, management consulting, and legal services, as well as higher insurance premiums caused by the increased business volume.

Interim income taxes were accrued in an amount of approximately €1.5 billion for the third quarter of 2021 and around €3.2 billion for the 9-month ended September 30th, 2021, and were recognized using the estimated annual effective income tax rate of approximately 31 %.

For the third quarter of 2021, net profit reached approximately €3.2 billion compared to a net loss of €210 million for the comparative prior year period. For the 9-month ended September 30th, 2021, total net profit reached approximately €7.1 billion compared to a total net loss of €351.7 million for the comparative prior year period.

As of September 30th, 2021, cash and cash equivalents totaled €2.4 billion. Please note that the contractual settlement of the gross profit share under our COVID-19 collaboration with Pfizer has temporal offset of more than one calendar quarter.

As far as the fiscal quarter for subsidiaries outside the United States defers some ours, creates an additional time lag between the recognition of revenues and the payment proceeds.

Consequently, trade receivables which were outstanding as of September 30th, 2021, where we received as payments only in October 2021, improving our cash position relative to the amount at September 30th, 2021.

Moving to Slide 34, our outlook for the 2021 financial year has been updated based on plant deliveries of up to 2.5 million doses in the calendar year 2021, with providing estimated COVID-19 vaccine revenues of approximately €16 billion to €17 billion for the full 2021 financial year.

This estimate reflects, expected revenues from direct COVID-19 vaccine sales to customers in our territory, expected revenues from sales to our collaboration targets, expected sales milestone payments from our collaboration partners and expected revenues related to our share of gross profit from COVID-19 vaccine sales in the collaboration part of territories.

Please note that, this figure has been estimated at constant foreign exchange rates. Please keep in mind that, we will deliver a significant number of doses to middle- and low-income countries. The prices are in line with income levels or at non-for-profit basis to serve the progress.

We maintained our previous cost guidance for the fiscal year 2021 and expect to incur R&D expenses in a range of €950 million to €1.1 billion reflecting a further ramp up of R&D investments in the fourth quarter of 2021, given our plans to expand and accelerate our part [Indiscernible] development [Indiscernible] expenses are estimated to be in a range of €250 million to €300 million.

Capital expenditures for the year 2021 I expect it to be in the range of €175 million to €225 million. These figures have again been estimated in constant foreign exchange rates and reflect our current base case projections.

Finally, please note that we still expect an estimated annual effective income tax rate of approximately 31 % for the BioNTech group. And with that, I turn the call to our Chief Strategy Officer, A - Ryan Richardson for an update on our corporate development activities and concluding remarks. Thank you..

Thanks, Jens. Moving now to Slide 3,6 in the third quarter, we acquired PhagoMed, a biotechnology Company based in Vienna, Austria.

The acquisition expands our infectious disease toolkit into synthetic license, a new class of precision antibacterial, which we believe have potential to address a wide range of pathogens, and also the growing global challenge in antimicrobial resistance.

In addition to its highly trained team, the acquisition brings us PhagoMed's Lysin Builder technology, a proprietary in silico therapeutics platform designed to enable the rapid production of recombinant natural license, which are optimized for potency, stability, and manufacturing yields.

The transaction which closed in third quarter, included an upfront cash payment of approximately, €50 million, in addition to potential future performance-based development milestones of up to €100 million. PhagoMed now operates as BioNTech R&D Austria, and will serve as BioNTech's R&D Hub for precision antibacterial.

We are pleased to add this new class of precision therapies to our Infectious Disease portfolio of mRNA vaccines and mRNA encoded antibodies. As you can see on Slide 37, we continue to expand our infectious disease capabilities and pipeline to address global health challenges.

In addition to our COVID-19 and influenza vaccine programs, which are partnered with Pfizer, we now have active research and pre -clinical development programs against more than 10 distinct infectious diseases. spending both vaccine and therapeutic approaches. Several of these programs could represent accelerated development opportunities.

For example, we plan to initiate first-in-human trials for our malaria and tuberculosis mRNA vaccine candidates in 2022 and look forward to providing further program updates in the coming months. Slide 38 depicts our clinical stage oncology pipeline, comprising 15 programs in 19 ongoing clinical trials across 4 drug classes.

With the new trial initiation so far this year, we now have 4 ongoing randomized Phase 2 trials in oncology. We expect our pipeline to continue to broaden as we head into 2022. I would like to point out that even though we have strong partners for certain programs including Roche, Genmab, and Sanofi. The majority of our programs are fully-owned.

And even when we have partnered, we have retained the right to co-commercialize our products in major markets alongside our partners. To close on Slide 39, we are poised to further accelerate the Company's transformation as we're heading to the final stage of the year. Our COVID-19 vaccine continues to be in strong demand globally.

And our production network continues to deliver at scale. Our oncology pipeline is advancing on multiple fronts. And we are similarly broadening our infectious disease pipeline of novel vaccines and therapeutics behind COVID-19. Hiring top talent continues to be a strategic priority.

And we have now expanded our team to more than 2,800 employees globally. We will continue to make investments in digital automation and manufacturing with further mRNA production centers planned in Singapore and Africa. Finally, we continue to expand our global footprint across geographies, including in Europe, the U.S, Africa and Asia.

As we look to build long-term value for patients, our shareholders and society. And with that, we can now open up..

Thank you. We'll now begin the question-and-answer session. [Operator Instructions] And your first [Indiscernible] is from the line of Cory Kasimov from JP Morgan, please go ahead..

Hey. Good morning, guys. Thank you for taking my question. I think I'm starting to a pretty obvious place, but on a broad level, can you talk about the type of impact you see the oral antivirals having on the demand for COVID-19 vaccines and boosters over both the short and long-term. Thank you..

I can take this question. I hope that you can hear me. I'm in the -- at the airport and there might be background noise. So, the overall inhibitors of costs, provide the opportunity for treatment if the disease is established.

The key question is indeed that, does the good use vaccination rate in the overall population, which we can't estimate at the moment.

We have to understand first of all that, how much this oil inhibitors will be available in 2022 at which percentage? And we have of course to understand that, the highest efficacy which was reported the last over a long a time, we know that single, single treatments plus inhibitors in viral disease of research in development of resistances and we have really to wait and see how this type of additional treatment, which is -- it's just fantastic to have now under market.

The complement or even complete the vaccines, and personally I don't believe that this will have a huge impact on the vaccination rate in future, but we have to monitor the field in upcoming future..

Okay. Thank you Ugur..

Thank you..

Yeah..

Your next question is, from the line of Chris Shibutani of Goldman Sachs, please go ahead..

Great. Thank you for the question regarding the outlook for the booster market, there are 2 important opportunities that impact the intermediate and longer-term outlook for your vaccine revenues, one being boosters for the broader adult population, not just the high-risk or elderly.

And the second being what would be the potential frequency going forward longer term of subsequent boosters, for instance, will it be annual? If we look back at how this played out for the original boosters, the evidenced came a few months before regulators and the advisory groups addressed the issue and got onboard.

What's your expectation for the evidence and the debate, and how this will play out for these 2 issues, 1. the broader population for booster recommendation and 2. the frequency of subsequent boosters longer-term? Thank you..

Yes. Yes. The value of booster vaccinations, not only for the elderly, but for the overall population is, becoming more and more evident.

So, we have real growth data, particularly from Israel showing that, booster vaccinations in the overall population can reduce dramatically the rate of infections as compared to the population who did not receive the booster vaccination in the range of 15 to 24 [Indiscernible].

And we have now evidence from our Phase 3 clinical trial that we compared the efficacy of a third dose -- of a booster dose in a randomized fashion and observed -- and additional booster increases [Indiscernible] efficacy of more than 95 %, which is in line with the strong and type of the responses that we observed in this population and disposed the overall population we didn't see any differences in the elderly and the younger population, indicating that booster vaccinations will be dramatically reduce the infection rate.

We believe that boosters have a great value in controlling the pandemic, particularly this winter where we have to deal on the one side was the challenge that the overall population is not -- the vaccination rate is still not sufficient to control the Delta variant.

And thus, the increasing reigning of vaccine responses, we will see also in the vaccinated population an increase of infections. So, we clearly see that, there is a scientific rational for boosting the overall population. How this will continue next year, we don't know. We have just to collect the data.

We, of course know that, this virus is relatively early in the evolution. And we will definitely see adaptations of the infection rate. We will see adaptations of antibody escape variants coming in, which will require which will publicly require adaptation of the vaccine.

But we can't say at the moment when this is going to happen but boosts us upcoming every 12 months or every 18 months or 24 months..

Thank you..

Thank you..

Thank you. Our next question is, from the line of Tazeen Ahmad from [Indiscernible].

Okay, guys. Good morning and good afternoon. Just a couple of points of clarification for me with regard to the [Indiscernible] presentations.

The first one was for 111, should we expect us to see an update on safety or will there be an update on efficacy, specifically I think back in March you had provided an update on disease for the survival numbers. Should we expect to see that updated at all? And then secondly, for 312, I think you're going to be keeping in many oral for that as well.

Similar question is the focus of that going to be primarily on safety or are we get a little bit more granularity on the doses that you're using in the dose escalation portion on what kind of efficacy to expect there. Thank you..

So, for BioN 11, we have now started the Phase 2 clinical testing and this trial will generate data earliest in 2023 from the Phase 2 clinical trial. For C1 3 trials, we will update on 6C about the clinical findings including the dose levels. And we will certainly provide updates during ASCO and ESMO next year..

Okay. Thank you..

All right..

Thank you. Your next question is from the line of Daina Graybosch of SVB Leerink, please go ahead..

Thank you for the question. I wonder if you could give us an update of where you are with your partners [Indiscernible] in China on regulatory approval and potential distribution..

Yes. Sure. I can take that one, Dana. So, we have -- we were granted Emergency Use Authorization in Q1 in Hong Kong and Macau, which is a Fosun territory and we've been distributing vaccine to that region over the course of the year.

We've also signed a 15 million dose deal with Taiwan, which is also a Fosun commercialization territory and have commenced shipment of vaccine to the Taiwan territory.

In Mainland China, we have submitted data for effectively a BLA Approval and we are still waiting for -- poor response from the regulator and still engage with the regulator to open up the approval pathway in mainland China..

Thank you. Your next question is from the line of Akash Tewari from Jefferies, please go ahead..

Hey, thanks so much. Just a few.

To follow-up on a prior question, what specifically in your feedback with the Agency, would you have to show to support boosters for all? Do you feel like the Agency is, focused on a drop-in protection for severe disease for the general population? And if so, what is the kind of threshold of protection that you think would support boosters for all versus not supporting boosters for all? And then, I -- consensus estimates for your COVID vaccine next year, around €16 billion.

So, in the ballpark of what you're tracking for 2021, can you talk about how many boosters specific contract doses you've already locked up and if replicating the sales, you had this year is a reasonable base case? Thanks..

I could take the first part of the question. And so, it just [Indiscernible] of course the overall data package at the time point. And when we requested access that authorization of the booster doses, we had data from some antibody responses, increase of neutralizing antibody titers. And we had data coming in from a year-ago, data from Israel.

We have now an additional data package from the randomized trials, which we are going to submit to further support booster doses in the overall population, showing a 95 % -- more than 95 % relative efficacy in subjects who received the third dose.

We believe that the increasing level of evidence for protection from disease by booster doses is an increasingly good argument to enable authorization of our vaccines in the overall population. My estimate is even though we see a good, good protection against severe disease even after 8, 9 and 10 months.

We will see also for protection from severe disease that, further decline maybe in the direction of 8 %. And if you calculate that, a booster dose could increase the overall protection against the DCs from 80 % to 97 % or 98 %, is a good reason to provide booster doses for the overall population.

So, we expect that, the evidence will increase over the next few weeks and months, and that this could lead to overall authorization of booster doses for the population..

Thank you. Ugur, maybe for the second question, I'll catch this as yes. You know that we announced that we intend to build up the capacity of production that we are able together with Pfizer to deliver next year to 4 billion.

Overall, in terms of guiding of what the final number for revenues will be, independent of the split between booster and standard sort of vaccination.

You got to bear with us until sometime early next year, please, generally you can envisage shut at this point were unable to give any split in terms of how much is booster and what will be actually the contribution of basic vaccination.

We all know that big part of this world is still not vaccinated at all percentages are very low specifically in low- and middle-income countries still, and therefore we have to look how things are evolving over time and then we will sometime next year give you an update on where we stand..

Thank you. Your next question is from the line of Daniel Wendorff of [Indiscernible] Please go ahead..

Thanks for taking my question and good afternoon -- good morning to everyone. My question would be in [Indiscernible] related to 2 vaccines eventually eligible for being booster shots against the new coronavirus.

Is that something very likely only limited to the mRNA vaccines or do you see any kind of other vaccine class potentially could be eligible for booster shots, potentially also looking beyond the third dose if it doesn't necessarily [Indiscernible] time to potentially have regular booster shots? Thank you..

I didn't get the question. Could you just specify your question again, please? I'm sorry..

Yes.

In simple terms, will it be just mRNA vaccines being eligible for being booster shot, or are there any new developments, adaptations to other vaccines, which would also make them likely to be available booster shots?.

We can't comment on other vaccines, but I don't see any firmer reasons why other vaccines should not be eligible for booster dosing. It is -- it will base of course on the availability of data and evidence that they provide a good risk-benefit profile..

Okay. Thank you..

Thank you. Your next question is from the line of Arlinda Lee from Canaccord, please go ahead..

Hi guys. Thanks for taking my question.

I guess, with your commitment to equitable access and certain price points during the pandemic, how do you think about pricing and access in terms of boosters pricing for the [Indiscernible] that still doesn't that maybe 1/10 and 1/3 of the original adult dose, and then potentially emerging out of its pandemic? That's all, thank you..

I'll take that one. I think with the middle-income, the lower-income countries, as we may follow the pandemic, you still have to consider what those countries contain. And that will be a consideration in how we calculate a future X pandemic price.

With the pediatric, again, I think you have to look at it from a value perspective, and not straight reduction in milligrams or micrograms per kick in terms of the price that, we would consider. But again, I would say that, that will certainly be an ex-pandemic price. And of course, we're currently working on that.

We're still very much in the pandemic..

Thank you. And our last question today is from the line of Ali Merrill from UBS, please go ahead..

Thanks so much for taking the question.

Just study business development strategy going forward, I guess just after PhagoMed acquisition, should we expect to see more deals of that sort? And I guess going forward, are there particular therapeutic areas or mortalities that, you are looking at most closely or that you think kind of synergize best with your platform and pipeline currently? Thanks..

Yes. I can take that question. Thank you. So yes, I think you've seen us do 2 acquisitions this year. The first, the acquisition of the solid tumor assets from Kite, that is TCR assets and cell therapy manufacturing facility in United States, and then now you're seeing the PhagoMed acquisition.

And I do think you can expect to see more of these types of deals. And our key criteria will be to broaden our technology base as with PhagoMed and to new classes of medicines that we think are complementary to our pipeline but also potentially clinical stage programs in our core therapeutic areas.

And by that I would include oncology and infectious disease as 2 key areas of focus..

Thank you. There are no further questions, please continue..

Thank you. With that we would like to close the call today. Thank you for joining today's call and we're looking forward to talking to you in future. Thank you. Bye..

That concludes the presentation today. Thank you for participating. You may disconnect..