Thank you for standing by and welcome to the BioNTech, Second Quarter 2021 Update Call. At this time, all participants are in a listen-only mode. There will be a presentation followed by a question-and-answer session [Operator Instruction] I must advise you the call is being recorded today on Monday, 08/09/2021.

I would now like to hand the call over to your Vice President of Investor Relations and Strategy, Sylke Maas. Please go ahead..

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

Before we start, we encourage you to view the slides for this webcast, as well as the operational and financial results press release issued this morning, both of which are accessible on our website in the Investors 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 and our estimated financial results for 2021. The continued global demand for our COVID-19 vaccine, our target vaccine production capacity for 2021 and beyond.

Our ability supply our COVID-19 vaccine, the planned next steps in our pipeline programs, the timings for enrollment, initiation, completion, and reporting of data from our clinical trials, and other risks described in our filings made with the U.S. Securities and Exchange Commission, including our most recent annual report on Form 20-F.

Actual results could differ from those we currently anticipate. We therefore, caution not to place undue reliance on any forward-looking statements, which speak only as of today shared today too in this conference call and webcast. Also, please note that line 3 and 4 provides detailed and important safety information regarding our COVID-19 vaccine.

I'm 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; Sierk Poetting, our Chief Financial Officer, Ryan Richardson, our Chief Strategy Officer; and Sierk Poetting, our Chief Operating Officer. And 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. Slide 6. I will provide an update on the last quarter's performance before inviting my team to go into further detail. Our performance in the second quarter continue to be strong [Indiscernible] and accelerate our pipeline of novel immunotherapies.

I am happy to report that we and our partner have crossed the 1 billion mark for COVID-19 vaccine doses shipped worldwide. We still have further to go to reach our ambitious targets for the full year, but we are on track with where we wanted to be at this time.

They are truly humbled by the impact our vaccine and our Company is having in addressing the global pandemic. We have also had a strong first half-year in terms of the number of new stats in oncology as they accelerate development of our bold pipeline. [Indiscernible] will go inside that detail with some of this new path in our prepared remarks.

Moving to Slide 7. Our strategy remains focused on developing a bold pipeline of next-generation immunotherapies and vaccines and bring them to key providers to address unmet medical need in cancer, infectious disease, as that is in a growing list of other diseases.

To accomplish this, we are building a fully integrated global immunotherapy Company anchored around deep expertise in immunology and complemented by an expanding set-up capabilities. To be more concrete what this means.

In addition to shipping modern $1 billion doses of our first authorized products, in the second quarter, we expanded our oncology patent to total 15 clinical-stage programs and 18 ongoing trials. I expect our patent to continue to broaden as we broaden our research and development and initiate additional clinical costs over the next 12 to 24 months.

We are also increasing investment to strengthen our cost capabilities, including our digital technology spectrum.

In the first half of the year, we have initiated a number of new research and development projects, which aim to explore the power of artificial intelligence and machine learning technologies across our research and development organization to discover and to optimize new immunotherapies.

BioNTech will become a technology Company of the coming age, exploring and exploiting innovations at the board of very uprising technology field. We believe in a future where our innovations can make a difference for many people around the world with the thesis that cannot be effectively created today.

Finally to accelerate the accomplishment of these objective, we have continued to hire exceptional people around the world, growing our firm to more than 2,500 team members in Europe, North America, and now Asia. We have remained focused on innovating and accelerating our pipeline with the aim, launching much of our products in the next 5 years.

Slide 8 shows the key highlights for the second quarter. Starting with COVID-19, there's now distributed vaccine doses to more than management countries and regions globally. As of July 25th, we and our partner has signed supply contracts for delivery of approximately $2.2 billion in 2021.

Further, they've committed to supply more than $2 billion of our vaccine to low and middle-income countries within this year and the next. This is a comfortable commitment that is only possible due to the investment we have made with our partners over the past 5 months to continue to increase our joint manufacturing capacity.

Now, being better over $3 billion. In oncology, we have initiated 6 trials in the first half of 2021. This include randomized phase II trials for our BMT 1116 and check on inhibitory refractory melanoma, and for BNT113 in [Indiscernible] cancer. For our IMS program, BNT122, we began screening patients in our phase II trial for acute colorectal cancer.

In addition to this later stage time, the initiatives, first in-human trial for the first programs from clean other platforms in the first half of the year. This includes our first cover [Indiscernible] program, our NEOSTIM ex vivo TCEP program and the first program from our [Indiscernible] platform, where we include cytokines in vivo using journey.

All of these programs are targeting sorting tumors and are wholly owned by BioNTech. [Indiscernible] Jens Holstein is our new CFO, with John our executive management team on July 3rd. Jens is an accomplished executive who brings deep experience as financial steward and operator.

His accomplishment enables them to fully focus on this forward as COO, going forward. We recorded Q2 revenues of approximately 5.3 billion Euros driven by the ramp-up of the COVID-19 vaccine production and delivery worldwide.

Finally, we recently announced the acquisition of Kite's personalized TCR research and development platform and the clinical-stage cell therapy manufacturing facility in Gaithersburg, Maryland in the U.S..

This transaction strengthens our position in cell therapy by giving us a turnkey clinical-stage cell therapy manufacturing site on both sides of the Atlantic. The site will support our growing clinical-stage cell therapy pipeline.

The acquisition will also provide us with a team of more than 50 highly specialized cell therapy experts and personalize TCR platform, which complements our pipeline of individualized cancer therapies that we aim to build a long-term leadership position. Turning to slide 9. We've seen infectious disease as a long-term growth pillar for BioNTech.

We believe the technology behind COVID-19 vaccine has the potential against a range of other infectious diseases. As that potential to play an important role in future pandemic preparedness programs.

They are investing on a vaccine program to address diseases, there's massive in particular, in lower-income countries, such as malaria, tuberculosis, and HIV. As part of this, we recently announced our plan to develop sustainable solutions to address infectious disease on the African continent.

We aim to develop the first mRNA vaccines, the viewable protected immunity for prevention of malaria, with the initiation of a clinical plan by the end of 2022. Malaria is a disease that affects more than 200 million people worldwide every year, the most affected being young children who have no immunity against this pathogen.

Our Malaria project is part of the Eradicate Malaria Initiative by the kENUP Foundation. The segment layout of our Malaria Project is dedicated to the development of sustainable vaccine production, an end-to-end supply solutions on the African Continent.

We are exploring possibilities for establishing state-of-the-art manufacturing facilities in Africa either with our partners or on our own. Our efforts are supported by the joint convening powers of the WHO and the Africa Center for Disease Control and Prevention.

Besides the WHO, the European commission and other organizations have been involved in the early planning phase of our Malaria Project and offer the extra thought to identify and set up needed infrastructure.

As reminder, we have amountable product candidates in preclinical development for tuberculosis and HIV in collaboration with the Bill and Melinda Gates Foundation. We plan to start the clinical trial for our tuberculosis vaccine candidate in 2022, only about 2.5 years after initiation of the research program.

As part of our collaboration with the University of Pennsylvania, we are developing up to 10 messenger vaccine candidates for various infectious diseases the time unmet medical need. With multiple programs and preclinical development, we expect to bring the product candidate in the clinic by the next year.

Finally, BNT161, the influenza vaccine program, Pfizer expects to initiate the first-in-human trial in the third quarter of 2021. They are eligible to receive milestone payments and up to double-digit royalties for this program through our licensing and payments with Pfizer.

On Slide 10, we show a depiction of the [Indiscernible] we are building across our technology platforms, which includes a diverse range of potentially first-in-class therapeutic approaches. But our focus, historically, has been on immuno-oncology.

We are investing to expand the application spectrum of our technology tool kit to address an even broader range of immunological targets and mechanisms of action. This means building out our platforms and even developing new complementary approaches which harness the power of the new system. To conclude on Slide 11.

We believe that the broad spectrum of our technology will enable us to bring forward new product paradigm that has the potential to broaden the disease horizon beyond oncology and infectious disease to allergy, autoimmune disease, and inflammatory diseases, and even regenerative medicine.

We believe that the new product paradigms that we are creating has the potential to expand on traditional top politic approaches. This includes mRNA vaccines for other infectious diseases that we believe our technology has the potential to improve efficacy or producibility beyond what has been achievable with other vaccine modalities.

We also see the opportunity for new modalities such as mRNA cancer vaccine or immunotherapies based on mRNA encoded proteins, such as our [Indiscernible] and [Indiscernible] set up kind platform.

And finally, we believe our toolkit quickly to new disruptive modalities at the intersection of mRNA and cell therapy such as our CARVac approach that use mRNA to address T-cell persistence in vivo. We will continue to combine our immuno-oncology expertise and power for seat of technology to unlock this new telepathic universe of opportunities.

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. Our partnerships with Pfizer and Fosun Pharma have enabled us to establish a global development program and distribution network.

It remains our goal to deliver as many doses of our COVID-19 vaccine as possible to people around the world to help end this pandemic and facilitate the return to a normal life. As the leading provider of COVID-19 vaccines globally, the demand for our vaccine remains high.

We have a strong order book in place for 2021 and several contracts already signed for 2022 and beyond shown on Slide 13. Discussion for additional contracts remains ongoing. As of 21st of July, we, along with Pfizer, have secured orders for approximately 2.2 billion doses of the vaccine to be delivered in 2021.

We expect the number of doses to continue to grow through additional orders. For example, we recently announced that the U.S. government purchased an additional 200 million doses, bringing the total number of doses under the existing supply agreement to 500 million. We expect to deliver 110 million of the additional doses.

By 12/31/2021, and the remaining 90 million doses no later than 4/20/2022. We also have a contracted supply, 900 million doses to the European Union for the years 2022-2023 inclusive, with an option for an additional 900 million doses. This is a historic development as it is the largest supply contract in the history of the pharmaceutical industry.

We have also contracted for more than 1 billion doses of our COVID-19 vaccine to date for 2022 and beyond. The U.S. government and the European Commission also have the option to acquire an updated version of the vaccine to address potential variance and also new formulations, if available, and also arise.

We are serious about our responsibility to help combat COVID-19 globally and are committed to ensuring that low and middle-income countries, many of which are experiencing serious outbreaks, receive our vaccine.

We anticipate that a significant amount of the remaining 2021 vaccine manufacturing capacity will be delivered to middle and low-income countries where we price in line with income levels or at a not-for-profit price. To this end, as Ugur mentioned, we have pledged to 2 billion doses over the next 18 months to ensure global equitable vaccine access.

This includes our plans to provide the U.S. government 500 million doses of our COVID-19 vaccine. Until now, not for profit price of which 200 million doses are in 2021 and 300 million doses are in the first half of 2022. The U.S.

Government will in turn donate the Pfizer BioNTech vaccine doses to low and middle-income countries and organizations that support them. This will further support the multi-lateral efforts to address the surge of infection in many parts of the world.

Recently, we, along with our partner, Pfizer, announced that we had signed a letter of intent to collaborate with Biovac for the manufacture and distribution of our COVID-19 vaccine in Africa. All vaccine doses manufactured at this new CMO signed will exclusively be distributed within the 55 member states and make up the African Union.

Moving now to Slide 14. As we've done on previous calls, I will provide an update of our key leavers to expand the global reach of our vaccine.

Starting with manufacturing, we have been continuously increasing our capacity, and the BioNTech and Pfizer global supply chain and manufacturing network now spans 3 continents and includes more than 20 facilities.

At this time, we expect to have up to 3 billion doses manufacturing capacity in place by the end of this year and up to 4 billion doses capacity in 2022. We will continue to expand our multi-continent manufacturing capabilities in the future by establishing new facilities in additional geographies.

I just mentioned our new collaboration with Biovac, which is located in Cape Town, South Africa and which will perform manufacturing and distribution activities in the region. We and our partner, Pfizer, immediately begun technology transfer, on-site development, and equipment installation at the new site.

At full operational capacity, buybacks, annual fill and finish capacity will exceed 100 million doses, allowing for more rapid distribution across the African Continent. We expect to begin delivery of vaccine doses from this site by 2022.

In our efforts to expand our vaccine label to more population, we are pleased that we have received expanded authorizations for adolescence, 12 years of age and older in the U.S., the European Union, and many other countries.

As we have discussed in detail previously, we have multiple ongoing clinical trials to support further label expansions, including in pregnant women and in children aged 6 months to 11 years.

We expect data from the study in children 2 to 11 years in the third quarter of this year, and data from children 6 months to 2 years in the fourth quarter of this year.

If the results from the study of positive, we expect to submit the data to regulators, including the FDA and EMA for potential label expansion for children 5 to 11 years old in the September to October 2021 timeframe. And soon after for children 6 months to 5 years. On the regulatory front, our U.S.

BLA submission for our COVID-19 vaccine was recently accepted by the FDA, and granted Priority Review designation. The Prescription Drug User Fee Act, or PDUFA date for a decision by the FDA is in January 2022.

The BLA includes clinical data from the pivotal Phase 3 trial of the vaccine, where the vaccine’s efficacy and favorable side effect profile works out up to 6 months after the second test. We are also pursuing submissions for standard approval in additional countries where emergency authorizations are currently in place.

In China, our BLA submission is underway too. In terms of optimizing vaccine formulations to simplify global access, we have received regulatory approval from both the EMA and FDA for storage of 2 degrees Celsius to 8 degrees Celsius for up to 31 days.

An ongoing Phase 3 trial is evaluating ready-to-use and lyophilized formulations, but data is expected in the third quarter of 2021.

As we continue to learn about emerging variants, our teams are rapidly responded to the dynamics of the pandemic by adapting technology, manufacturing and regulatory processes to ensure we continue to have a robust vaccine that protects humanity from COVID-19.

To address potential waning immunity and emerging pyro variance, we have expanded trials to expand both variance, specific versions of BNT162b2, as well as the third dose of BNT162b2, given 6 to 12 months after the second dose.

Initial data from the BNT162b2 booster trial have been recently disclosed and Ozlem will now provide you further details on our boosting and variant strategy. I will now turn the call over to Ozlem..

a short half-life, requiring frequent and high dosing associated with toxicities such as infusion reaction and liver toxicity. Our RiboCytokines are designed for improved pharmacokinetic properties with a prolonged serum half-life and high bioavailability. This allows for lower and less frequent dosing which may result in better tolerability.

A RiboCytokine encoding cytokine fused to human albumin. The RNA backbone is optimized for high protein production, and it is nucleoside-modified then that's non-immunogen. The RNA is encapsulated in liver-targeting LNP that allow for intravenous systemic delivery.

Shown on Slide 32, we have 2 RiboCytokine product candidates in the clinical trials that feature IL-2. A key cytokine in T-cells immunity supporting differentiation, proliferation, survivor, and effector functions of T-cells.

In addition, for activating effector T cells, IL-2 as a physiological counter-regulatory mechanism, also activates suppressive regulatory T-cells by a one of its free cellular receptors namely the IL-2 receptor as a subunit, also referred to as CD25.

BNT151 is a sequence modified IL-2 engineered to reduce binding to this subunit with maintained binding to the other IL-2 receptor. Thus, without extensively triggering immune-suppressive regulatory T cells, it activates effector anti-tumor T cells with a preference for those effectors that have low to no expression of CB25.

As such, we anticipate at BNT151 was an optimal combination partner for anti-PD1 or anti-PDI-1 therapy. With BNT151, a Phase I trial is ongoing. Our BNT152-153 product candidate has two components.

BNT153 encodes a natural IL-2 with maintained high-affinity binding to [Indiscernible] positive T-Cells accordingly stimulates recently activated anti-tumor T-cells and regulatory T-cells.

BNT152 the second component of this product candidate encodes IL-7, which sensitizes T-cells to IL-2 while control fraction of immunosuppressive regulatory T-cells. We believe BNT152 plus 153 could be a potent combination from a partner for cancer vaccines. A vaccine is used T cells expressed high levels of CD25.

We dosed the first patient in June 2021 and a first human Phase I trial in patients with solid tumors. We plan to combine this combination of T-cell formula static cytokines with other products of our pipeline for example with our FixVac platform.

Now to wrap up my part for today, Slide 33, which highlights a number of key milestones achieved so far this year, as well as significant milestones we expect from the back half of 2021. In addition to our clinical update from COVID-19 vaccine programs, we expect far more data update for our oncology programs.

We have started two randomized Phase II clinical trials with one more expected to start in the second half of 2021. We have started to 4 first in human clinical trials of [Indiscernible] therapeutic programs and expect 3 more this year.

We have made significant progress with regard to accelerating our pipeline in the first half of this year and I look forward to updating you on upcoming milestones in the near future. So I now turn over to our Chief Financial Officer, Jens Holstein who will discuss our financial results..

Thank you, Ozlem. And a warm welcome to those of you on the phone. I've been in my role a few weeks now, and I'm delighted to have joined BioNTech at this exciting time in the Company's growth trajectory. It's a great pleasure. I look forward to supporting my colleagues in our mission to make a significant impact on human health.

Let me now start my section by moving to our Financial results for the second quarter of 2021 as shown on Slide 35. I'll start with total revenues estimated to be approximately EUR5.3 billion for the second quarter of 2021, compared to EUR41.7 million for the comparative period in 2020.

For the period of 6 months ended June 30, 2021, we report an estimated total revenue of around EUR7.4 billion compared to EUR69.4 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 collaborations, territories have been allocated between us, Pfizer and Fosun Pharma based on marketing and distribution rights. A breakdown of our commercial revenues is shown on Slide 36.

Our second quarter 2021 commercial revenues include approximately EUR4.1 billion and EUR5.8 billion for the first 2 quarters of 2021 that comprise our gross 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 EUR168.6 million for the second quarter and EUR415.8 million for the period of 6 months ended June 30th, 2021. Similar to previous quarters, the figure for our profit share are estimated based on preliminary data shared between Pfizer and us.

It may be subject to adjustments, pending final data, and input parameters like sales volume, end values, as well as transfer prices. Any changes in our share of the collaboration partners gross profit will be recognized prospectively.

Our COVID-19 vaccine commercial revenues in the second quarter also include EUR138.1 million in sales to our collaboration partners of products manufactured for us in around EUR1 billion of direct COVID-19 vaccine sales to customers in our territory, Germany and Turkey.

For the period of 6 months ended 6/30/2021, we had sales to our collaboration partners of EUR202 million and approximately EUR1.2 billion direct COVID-19 sales in Germany and Turkey.

Now, returning back to Slide 35 and moving to cost of sales, which were estimated to be EUR883.8 million for the second quarter of 2021, compared to EUR5.6 million for the comparative period in 2020.

For the 6 months ended 6/30/2021, total cost of sales were estimated to be around EUR1.1 billion, compared to EUR11.5 million for the comparative prior-year period. The increase was driven by an estimated amount of EUR872.1 million for the second quarter of 2021, around EUR1.1 billion for the period of 6 months ended June 30th, 2021, respectively.

That was recognized as cost of sales with respect to our COVID-19 vaccine sales and included the share of gross profit that we owed to our collaboration partner Pfizer, on all sales. Research and development expenses were EUR201.1 million for the second quarter of 2021 compared to EUR95.2 million for the comparative period in 2020.

For the 6 months ended June 30th, 2021, research and development expenses reached EUR417.3 million compared to EUR150.3 million for the comparative prior-year period.

The increase was mainly due to an increase in research and development expenses related to our BNT162 program recorded as purchase services with respect to those expenses which were initially incurred by Pfizer and subsequently charged to us under our collaboration agreement.

As a reminder, development costs are shared equally between the 2 companies. The increase was further driven by an increase in wages, benefits, and social security expenses due to increases in headcounts. Recognizing inventor compensation expenses, as well as expenses impaired under the new share-based page arrangements.

General and administrative expenses were EUR47.8 million for the second quarter of 2021 compared to EUR18.8 million for the comparative period in 2020. For the 6 months ended June 30th, 2021, general and administrative expenses were EUR86.7 million compared to EUR34.6 million for the comparative prior-year period.

The increase was mainly due to an increase in wages, benefits, and social security expenses for increasing headcounts and recognized expenses incurred under the new share-based payment arrangements. Higher expenses for purchased management, consulting, and legal fees, as well as a higher insurance premium.

Interim income taxes were approximately EUR1.2 billion for the second quarter of 2021, around 1.7 billion for the 6 months ended 06/30/2021 and were recognized using the estimated annual effective income tax rate of approximately 31%.

For the second quarter of 2021, net profit reached approximately EUR2.8 billion compared to a net loss of EUR88.3 million for the comparative period in 2020. For the 6 months ended 06/30/2021, total net profit was approximately EUR3.9 billion compared to a total net loss of EUR141.7 million for the comparative prior-year period.

As of 6/30/2021, cash-in cash equivalents totaled EUR914.1 million. Please note that the contractual settlement of the gross profit share under our COVID-19 collaboration with Pfizer is a temporal offset of more than one calendar quarter. As Pfizer assistive quarter for subsidiaries outside the U.S.

differs from ours, creates an additional time lag between the recognition of revenues and the payment receipt. Consequently, trade receivables, which were outstanding as of 6/30/2021, were received as payments only in July 2021, improving our cash position relative to the amount of 6/30/2021.

Moving to Slide 37, our 2021 financial outlook has been updated as we expand and accelerate the development of our broad pipeline. Based on the current contraction supply orders of approximately 2.2 billion doses. We're providing estimated COVID-19 vaccine revenues to BioNTech in 2021 of approximately EUR15.9 billion.

This estimate reflects expected revenues from direct COVID-19 vaccine sales to customers in our territory, expected revenues from sales to our collaboration partners, 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 towards enough territory.

Please note that this figure has been estimated at constant foreign exchange rates. We expect additional revenues related to further supply contracts for deliveries in 2021 with contracts in place for 2022 and beyond.

Please keep in mind that we will deliver a significant amount of doses to middle and low-income countries with prices are in line with income levels or a non-for profit basis to serve the poorest.

In terms of guidance for the full year 2021, we expect to incur R&D expenses in the range of EUR950 million to EUR1.05 billion, reflecting a ramp up, especially in the second half of 2021, given our plans to expand and accelerate our pipeline development. SG&A expenses are estimated to be in a range of EUR250 million to EUR300 million.

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

Finally, please note that in terms of full-year 2021 tax impact, we still expect BioNTech Group estimated annual effective income tax of approximately 31%. And with that, I turn the call to our Chief Strategy Officer, Ryan Richardson for an update on our corporate development activities and concluding remarks..

Thank you, Jens. Moving now to Slide 39, I'd like to briefly discuss our recently announced acquisition of Kite Pharma's Personalized TCR platform and manufacturing facility in Gaithersburg, Maryland.

Cell therapy forms an important component of our immuno-oncology toolkit alongside our mRNA cancer vaccines, antibodies, small molecule immunomodulators, engineered biologicals, and next-generation immunomodulators.

This acquisition adds to our cell therapy capability and specialize infrastructure to support our growing cell therapy pipeline, which spans CAR T-cell therapy, Neoantigen ex-vivo T-cell therapy, and personalize TCR-T therapy.

Turning to Slide 40, the Gaithersburg facility we've acquired will provide a turn-key production site to support clinical trials in the U.S., complementing our existing cell therapy manufacturing facility in Idar-Oberstein, Germany. The new U.S.

site will support the development of our expanding pipeline of novel cell therapies, including cancer product candidates based on our CARVac program and NEOSTIM platforms, as well as the newly acquired individualized Neoantigen TCR program from Kite.

Further, as a result of the acquisition, BioNTech will gain a team of more than 50 professionals with the deep expertise in cell and gene therapy, including a cell therapy production team and a personalized Neoantigen TCR research team. This acquisition further supports our leadership position in individualized cancer therapy.

Slide 41 highlights the three individualized treatment platforms we are developing in-house at BioNTech to address solid tumors. These include BNT122 iNeST and BNT 221 NEOSTIM, and our personalized TCR program.

Each of these modalities explored to distinct mechanism of action and is uniquely suited to specific tumor types, broadening the types of solid tumors we can target. And then digitalized mRNA cancer vaccine use the patient's own cancer mutations to generate neoantigen-specific CD4 and CD8 T-cell responses in vivo.

We believe this modality is well-suited to early adjuvant stage cancers. NEOSTIM, in our individualized neoantigen-T cell therapy, which uses PBMCs to induce and expand multiple CD4 and CD8 neoantigen-T cell populations ex vivo. This modality is expected to enter the clinic in 2021, targeting checkpoint of non-responsive tumors.

Finally, the Kite TCR platform acquisition strengthens our own in-house personalized TCR -T cell therapy program, which leverages ex vivo engineered neoantigen-specific TCR -T cells to address advanced tumors. We believe the breadth of these therapeutic modalities position us well to usher in a new era of individualized cancer therapy.

To conclude on slide 42, we have strong momentum in our business as we move into the second half of the year. Our COVID-19 vaccine is continuing to have a major impact in addressing the global pandemic, and there is early data supporting the potential benefits of an additional booster dose.

Moreover, our oncology pipeline continues to expand with the first wave of programs now advancing into later-stage trials. We expect a number of significant clinical trial updates in the second half of 2021. These include four data readouts in our oncology programs and the start of our fourth randomized Phase II trial.

Additionally, we're on track to start to more first-in-human trials this year. We are transforming our business through additional investments into our technology platforms, building out our global team and expanding our list of collaborators.

We believe that we're well-positioned for success as we executed in our strategy to achieve our vision of harnessing immune systems full potential to fight human disease, and our strong financial position enabled us to invest more than ever.

And our firm and our innovation engine with the aim to build true long-term value for patients, shareholders, and society. We thank our shareholders and partners for their ongoing collaboration and support. And with that, we'll conclude our presentation and open up for questions..

Thank you [Operator instructions] Please stand by while we compile the Q&A roster. Your first question comes from the line of Cory Kasimov of JP Morgan. Please ask your question..

Great. Good morning -- good afternoon, everyone. Thanks for taking the question. I wanted to ask you about your booster strategy with the new Delta trial and the ongoing tests and you're doing for the Beta specific vaccine. Now there's not surprisingly to talk about the emergence of additional variance.

Is it your expectation that the original vaccine will ultimately be best to use for boosting, especially given the emerging data that you have there? Or do you think this is going to trend towards some type of multivalent product in the future? And just related to that [Indiscernible] your thoughts around some of the commentary out of organizations like the CDC around boosters and whether you think it's going to take a surge and breakthrough infections to really mobilize the idea of boosters on a broader basis.

Thank you..

I can take this question. Hi, Cory. At the moment, our studies, which we have performed with specific lab experiments clearly show that subjects who had received the dose had show increased neutralization antibody type of, not only against the original variant, but almost with the same level, also against the Delta variant.

We believe that the best approach at the moment to deal with the situation is to continue with a booster dose with the existing wild-type strain, which creates antibody responses which are about fivefold higher than the antibody titers -- neutralizing antibody titers after the second shot.

It is quite possible that in the next 6 months to 12 months further variants emerge and that would require adaptation of the vaccine. But it is, at the moment, not yet the case..

Thank you. Your next question comes from the line of Tazeen Ahmad of Bank of America, please ask your question..

Hi. Good morning. Thanks for the very similar update. My one question is in relation to the strategy around booster. How much of the view that a third dose of the original vaccine is efficient in the current environment is based on potentially not enough of the population being vaccinated, thus allowing the virus to continue to spread.

And so if the pace of vaccination does increase in the future, would you continue to believe that the booster of the original shot will be sufficient? Or do you think that we would move to a more specified plan of boosting just when you have different variants emerging? Thanks..

I can take this one. The same as Ugur has pointed out.

The current strategy, which is based on the currently available data, is to continue with the ancestors train so with the current variant or with the original vaccine and rather than adapting just to boost with that train and a large part of this data of the supporting data comes from, for example, neutralizing anti-body specimens who -- I have presented one piece of data, but there's also other data from other groups.

I would say that would shows that the vaccine -- the ancestral vaccine generates antibody titers -- neutralizing antibodies which are cross-reactive. Even those after the second dose and cross neutralizing towards other strains, including the Delta variant and specifically our third dose Beta. We have also shown this after the second dose.

Our third dose data shows that the highly boosted antibodies neutralizing antibodies. And as you actually see they are above the ones we generate with the second dose also, cross-neutralizing against Data but also against Beta. So it is a robust strategy to continue with boosting with the ancestral strain.

I have also shown our plans going forward in terms of producing additional data and to better understanding what adapting the strain could bring in terms of added value and added safety margin.

This is the data from our plans and ongoing clinical trials where we would vaccinate naive subjects, but also subject who have received the first 2 dose series with the ancestral strain. These will be vaccinated with the South Africa variant, but also with the Delta and other variants as individual vaccines, but also as multi-variant vaccines.

And these studies will tell us once we are able to investigate and met the immune responses and understand also that efficacy, whether it is required and what, in terms of additional benefit, it would bring to adapt the vaccine. So this is definitely something which will be investigated and might be then the strategy for the future..

Thank you. The next question comes from the line of Chris Shibutani of Goldman Sachs please ask your question..

Thank you very much. I did want to ask some practical question about the booster. It seems as if we will get the Phase 3 readout in the fourth quarter.

Would you anticipate that that is a data requirement for an emergency use authorization for the booster? And in that scenario that we get a full approval of the initial doses, how would it work practically speaking, in the commercial ground where you may have the initial doses fully approved and a booster on an EUA? Thank you..

I can take the question. But what -- what we expect is that based on the data that is generated including the safety data. The recommendations for use of booster doses, booster doses would come in different regions. So there are already recommendations, for example, Israel to use booster doses.

Also, Germany recommended the use of booster doses in elderly, and this will happen. This happens under emergency use.

And what needs to be or what is going on is, on the one side in parallel -- this is, of course, something that we can't tag influence is the primary vaccination of those who have not received the vaccine to immediately defuse the infection and on the other side, to -- if this is recommended, to enable booster vaccination for both who have received prime-boost vaccination, 5 or 6 months ago to ensure an increase of antibody targets.

But that means this things will happen in parallel. And country-wise or region-wise recommendation may support different policies..

So are you implying that an E UA has the potential to be a designated [Indiscernible] populations for the booster, particularly with the U.S.

FDA?.

Yes. It is -- you would need really region bias. Region bias, different projects for cancer for Europe. It's, first of all, the approval, which is the first step, and then in different countries. And they are either recommendations by the vaccine committees or policies which are coming from government.

It is maybe different per region as every region will come up with a solution, so it'll be a mixed solution and mixed policies..

If I may add here, this is a pandemic situation that's also an unusual situation in terms of regulatory pathway.

We are working with the health authorities and how exactly the implementation of third doses within EUA for submissions at some point should be implemented in order to ensure that This or search for overall has fractured strategy of a respective region or country.

This is something which we need to be worked out together with the help of our [Indiscernible] which will guide. I would not want to speculate what exactly is late time, the label also full approval, or in the EUA business really working progress in the interaction, whether it's active regulatory authorities and ambiguous with the FDA..

Okay, thank you. Sounds quite dynamic. We'll keep tabs, appreciate it..

Thank you..

Thank you. The next question comes from the line of Daina Graybosch of SVB Leerink. Please ask your question..

Hi. Good afternoon, good morning. Thanks for the question. I wonder if you could talk a bit more about your business development approach and what you are looking to do is that maybe near-term and long-term in terms of capabilities, capacity, targets, or modalities.

And also with that, do you believe that you need your own PD-1 to support your rich portfolio of IO program?.

Hi Daina.

What's the question about the business strategy or about the developments strategy?.

Business development so licensing an acquisition strategy..

I see, I see. So Daina, we are at the moment. on the one side accelerating and broadening our internal pipeline.

And of course we are interested also in complementing our pipeline with additional IO molecules So PD-1 molecules could be an option if it fulfills the criteria that we're seeking, we have at the moment, own IO molecules also does that PD-1 blockade function in development as you know, and in custody of our PD-L1+ program VP by specific, is one of the molecules.

And we have internal programs also addressing additional IO pass. And then the next 12 to 18 months, we will certainly come up with this deal allowing us to increase our pipeline and to further gain combination partners for the vaccines and the immune modulator that we have already in place..

Very helpful. Thank you..

Thank you. The next question comes from the line of Zhiqiang Shu of Berenberg. Please ask your question..

Hi. Good morning. Good afternoon. Thanks for taking my questions. I'd like to also ask are the booster opportunity here. Given the waning protection of the vaccine -- I think a critical question is about the T-cell response.

Well, can you talk about based on our current understanding, what is the role of T-cell response, particularly memory T-cells and T-cells here in terms of configuring the protection. Also, I want to ask about the oncology pipeline regarding FixVac.

How should we think about the local cross -- read across different cancer types as it related to allergy of a tumor types or related selection of the Neoantigen? Thanks very much..

Let me start with the first question, role of T-cells. So we have two layers of immunity against this virus. The first layer is the neutralizing antibody response, and the third layer is responsible, responsible for inhibiting the uptake of the virus, is inhibiting the infection, and the second layer is once the virus has managed to enter the cells.

Then the T-cells, the second layout, these CD8 T-cells, which are able to recognize infected cells and care to recognize kill the cells, as well as CD40, which had to further accelerate antibody and T-cell responses to with restore the antibody response.

And we know that in animal experiments, it's known for SARS virus for more than 20 years the T-Cells protecting against severe disease. And there are a number of publications now indicating that this is the case also for SARS-CoV-2, so that means the presence - the sheer presence of T-cells, it's inhibiting the development of severe disease.

And this is in line with what we are observing in the drug studies. So even though the decreasing antibody titers, there are more breakthrough infections. Most of the infections are mild and severe disease is still protected, and the reason for that is that the T cell response is lasting longer. The T cell responses can last up to many years.

And but we -- and therefore, the situation is that we will get fatal infections, but most of the will be -- of the people will be protected against severe disease. Does this answer your first question? And can you repeat your second question, please? I forgot it..

Yes. The same question. I'd like to ask you about are we across different tumor types regarding your FixVac, obviously you have quite encouraging data in melanoma.

And how should we think about other types?.

Yes, we have 2 approaches for inducing antigen-specific immune responses in cancer patients. It's the FixVac. The FixVac is a combination of antigens which are specifically tailored for a certain cancer type. We have FixVac melanoma. We're developing a FixVac lung cancer.

We have a FixVac non-small cell FixVac for varying cancer, FixVac head and neck cancer. These are collections of antigens for specific. And the compliment that we approach is the iNeST approach, which is targeting cancer with the individualized session, where we use a universal approach.

That means this approach would be universally applicable to all kinds of cancer. And it is based on the concept that we identify personal Neoantigens and tailor and individual vaccine. And since the support is universal in this nature, it could be applied to many different cancer types.

We have a iNeST clinical trial of in normal and we have a basket higher in multiple indications, finding it still a Phase I study and we have just recently started anti using essentially same approach for colorectal cancer..

Great. Thanks very much. Congrats on the progress..

Thank you..

Thank you. Your next question comes from the line of Arlinda Lee of Canaccord, please ask your question..

Hi, guys. Thanks for taking my question. I was also curious about the booster and maybe your broader strategy on the COVID situation. I know it's fluid, but on the multivalent, could that include others SARS COVID, two proteins and I saw that you guys were looking at adding for additional variants.

And then I guess maybe as a follow-up to that, how easily can your manufacturing setup change to manufacture some of these variance? Thank you..

Thank you. So starting with the last section. We have the ability to rapidly change the strain from manufacturing. The only step that we need to do is to use another DNA template for a new variant and then we can keep the complete manufacturing process without any changes and generate the vaccine, which adapt to the value.

So this is technically possible, and we are already doing that in claim of clinical trials, and this was behalf earning trial for the better variant. And we are going to start in this month. Also at Sylke against the Delta variant.

And as the key question is and this is not only a question for BioNTech, but it is more general question for the health authorities and for the public. When is the best time to change a strain.

So we have a situation for example in -- for that the plans defined every year by the WHO and manufacturers and just could use the vaccines for the development plan. We do not yet have such a situation for the corona virus and the challenge at the home and the global challenges that they had different variants on different continents.

Even though the Delta variant is dominating most regions, there are other regions, for example, South Africa where other variance are more prevalent, and therefore, we would really need to get the perfect timing to make a decision for a new variant vaccine.

And the decision should be based on first the understanding that the existing vaccine boosters the existing vaccine will not rot or is sub-optimal. And the second understanding is that we really hit the right variant. And whether this is a senior variant.

And we had such a case for example with the Alpha variant where there was a senior variant which is really a dominant one. But with the Delta variant we are now at the moment seeing the Delta variant and Delta plus variant, it is not yet clear which of the past variant might emerge.

So it's -- making a decision at the moment might turn out to be wrong in 3 or 6 months if another variant is dominating. Therefore, the timing of the positioning must be appropriate and one of the regions, it does not make sense to change to a Beta variant to the extreme now.

At the moment we have a good understanding that the booster vaccine with the parental strain is completely sufficient. There is no need to change the variant and we don't know what is happening -- going to happen in the next few months.

But if it turns out that for example in 6 or 9 months new variants emerge which require booster, we will -- we need them to understand, if you go over the monovalent vaccine, that's just the new variant, or if they're multiple variance, if we go with the vaccine which has several variants.

All of these options are technically executable with mRNA vaccine and we prepare ourselves to ensure, regardless what kind of solution is needed, that we can execute that..

Thank you..

Thank you. And our final question comes from the line of Simon Baker of Redburn. Please ask your question..

Thank you very much for taking my question.

Just continuing on the issue of boosters and in relation to the last question, could you give us an idea of the lead time from identification of the desirable variant for new vaccine to how quickly you could get it into volume manufacturing? And if I may just a very quick P&L question, could you give us an idea of how representative this quarter's gross margin is for the rest of the year.

Thanks so much..

We had communicated that we can do a change in less segment on the phase. And this technical progress to fund another phase will become shorter with time because they are improving other methods and making it more efficient. That's the first part of the answer and maybe Ryan or Sierk can -- or Sean could answer the next question..

Yeah, happy to take that question, Simon. This is Sean. Of course, the revenue development, as well as, the cross margin development depends highly on the mixture. So if the revenues are coming from our collaboration with Pfizer or from Milestones or from delivery products to our collaboration partners.

And that obviously influences the gross margin to a great extent.

In addition, please keep in mind that going forward, there will be also quite a number of deliveries of products from ourselves, but mainly from our partners of course, where we deliver to middle and low-income countries for which we have lower prices of course, or a non-profit -- non-for-profit prices.

So that influences the gross margin going forward to some extent. So towards the year-end, I would expect that maybe in Q3 or Q4, you will see a slight decrease of the margin that you have seen in Q2..

Perfect, thanks so much..

Thank you. I will now hand the call back to Sylke Maas to close..

Thank you again for joining the call today. We look forward to speaking with you in future. Thank you. Bye..

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect..