Good morning, and good afternoon. Thank you for joining us today to review BioNTech's third-quarter 2020 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, BioNTech's efforts to combat COVID-19; the potential safety and efficacy of BNT162; the timing for submission of data for, or receipt of, or potential approval or Emergency Use Authorization with respect to our BNT162 program; the ability of BioNTech to supply BNT162; the planned next steps in BioNTech's pipeline programs; the timing for enrollment initiation, completion and reporting of data from our clinical trials; and BioNTech's anticipated cash usage for fiscal-year 2020 and beyond. Actual 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 the date of this conference call and webcast. On the call with BioNTech management today will be Ugur Sahin, our Chief Executive Officer and Co-Founder; Özlem Türeci, our Chief Medical Officer and Co-Founder; Sean Marett, our Chief Business and Commercial Officer; Sierk Poetting, our Chief Financial and Operating Officer; and Ryan Richardson, our Chief Strategy Officer. The agenda for today's call is shown on Slide 3. Ugur will start with Q3 highlights and an update on our COVID-19 program before handing over to Sean to provide an update on our commercial distribution plan for BNT162. Özlem will then update on our oncology pipeline. She will walk through some of the data we are highlighting this week at SITC for BNT311, our PD-L1x4-1BB checkpoint immunomodulator. Sierk will then provide a recap of our financial results for the third quarter and our financial outlook for the rest of 2020 before handing back to Ugur for concluding remarks. We will then open the call for Q&A. I now hand the call over to Ugur Sahin, BioNTech's CEO.

Thank you, Sylke. Good morning, and thank you to everyone joining the call today. Let's start with Slide 4. I am incredibly happy about the accomplishments we can report to you today. We announced yesterday that our COVID-19 vaccine program demonstrated evidence of efficacy against COVID-19 based on the first interim analysis. Just to remind you, so far, we have continued to see evidence from mild-to-moderate tolerability profile in our Phase 3 trial, which is consistent with what we have observed in the earlier studies. We believe the news from yesterday represents a watershed milestone for our company, and one that we believe will constitute an important step for the world after more than eight months into the worst pandemic in modern century. When we made this decision to initiate a COVID-19 vaccine program in January, we did that against a backdrop of considerable uncertainty. For example, it was not known at that time point if a vaccine would work at all. But when that decision was made, we went all in, with the hope of considerable resources, both in terms of time and attention, human resources, and also capital toward addressing this challenge. We did so without knowing how the pandemic would play out. We did so because we felt a duty to try and to do something because we believe our technology has the potential to make a difference. And with the news this week, I believe, now more than ever that we are in the position to make that difference. And we will still have a lot of work to do, and we'll continue to focus on the goal every single day. We, along with our collaboration partner, Pfizer, have already initiated the regulatory submission process to the EMA, to the MHRA in the U.K., and to…

Yes. Thanks, Ugur. So just turning to Slide 9. Here, we're providing a snapshot of where we are on the commercial side. Demand is strong around the world. We currently have entered into commitments with purchases to supply more than 570 million doses by the end of 2021 with options in the United States and Europe for an additional 600 million doses. We continue to work diligently with Pfizer to complete additional commercial supply agreements and are in negotiation with a number of governments around the world and other bodies like COVAX. All agreements, of course, are subject to clinical success and regulatory approval of the vaccine. Just moving on to Slide 10. Here, we're highlighting the distribution model that we expect for the vaccine in the pandemic phase. We have a co-commercialization arrangement in place with Pfizer, as many of you know, and are really working very, very closely with them and with the governments for global distribution. Pfizer has developed a thermal shipper unit, which has GPS tracking, specifically for this vaccine, which is designed to keep the product at low temperatures for up to 10 days if stored at 15 to 25 degree Celsius without opening the shipper. And if we do open it, then upon reicing several times we can extend to 15 days on reopening. Further, we have the ability for five days storage in a refrigerator at 2 to 8 degrees centigrade. So that gives us really some flexibility with respect to storage and distribution. And the distribution model will, of course, depend on the region. But in general, we are engaging specialized supply chain providers, which we've indicated in the picture here, for air and ground shipping to and from our manufacturing sites in Europe and the United States to distribution hubs all…

Yes. Thank you, Sean. We are changing gears now. And on Slide 12, you can see our clinical oncology pipeline. In the interest of time, I am going to provide updates on selected programs only. And for BNT311 detail the data released yesterday at the SITC conference. For further details on the status of other programs, please refer to our quarterly update, which we released this morning. I want to note that we have seen some continued impact from the ongoing COVID-19 pandemic on our clinical operations. Specifically, there has been a slowdown in the enrollment of some of our ongoing studies and impairments of clinical site initiation of our planned studies. This is causing us to delay timelines for some of our programs. Now, starting with BNT111, our melanoma FixVac program on an RNA vaccine, which is composed of four non-mutated melanoma antigens. Recently, we published an exploratory data analysis in Nature from our ongoing Phase 1 trial. The publication highlighted the favorable safety profile of BNT111 in Stage 3 B-C and stage IV melanoma patients who were pretreated with several lines of therapy, including PD-1 inhibitors. Our publication also noted BNT111's ability to mediate durable objective responses, both as a single agent and also in combination with approved anti-PD-1 antibodies, nivolumab, and pembrolizumab. During the first quarter, we entered into a strategic collaboration to pursue a development program with our colleagues from Regeneron. We plan to investigate the combination of BNT111 and Regeneron's PD-1 blocker, Libtayo, also known as cemiplimab, in patients with unresectable stage III or IV melanoma, who have progressed under or after treatment with PD-1 blockade. The Phase 2 randomized and open-label trial is expected to include 120 participants who will receive either BNT111 and cemiplimab in combination or either of these compounds alone. The…

Thank you, Özlem. I would like to summarize our financial results for the quarter that are shown on Slide 22. So our total revenue, which primarily consists of revenue from our collaboration agreements, was EUR 67.5 million for the third-quarter 2020, compared to EUR 28.7 million for the third-quarter 2019. So for the period of nine months ended September 30, 2020, our total revenue was EUR 136.9 million, compared to EUR 80.6 million for the comparative prior-year period. The revenue from collaboration agreements overall increased due to the recognition of revenue from our new collaboration agreement signed with Pfizer and Fosun Pharma as part of the company's BNT162 vaccine program against COVID-19. These revenues from upfront payments are recognized based on the underlying costs incurred and increase with increasing costs. The revenues from other sales transactions increased due to increased orders and include sales of diagnostic products, peptides, retroviral vectors for clinical supply and development, and manufacturing services sold to third-party customers. Research and development expenses were EUR 227.7 million for the third-quarter 2020, compared to EUR 50.4 million for the third-quarter 2019. For the nine months ended September 30, 2020, total research and development expenses were EUR 388 million, compared to EUR 161 million for the comparative prior-year period. This increase was mainly due to an increase in the development expenses from our BNT162 program. In addition, from the date of acquisition of our new U.S.-based subsidiary, BioNTech US Inc. contributed to our research and development expenses. General and administrative expenses were EUR 23.3 million for the third-quarter 2020, compared to EUR 10.6 million for the third-quarter 2019. For the nine months ended September 30, 2020, total general and administrative expenses were EUR 58 million, compared to EUR 34.5 million for the comparative prior-year period. This increase was mainly…

Thank you, Sierk. So turning to Slide 24. As we enter the final weeks of 2020, we are focused on executing our ongoing Phase 3 trial, COVID-19 vaccine, and planned submissions along with our partners. We are preparing for commercial launch and with our partners, Pfizer and Fosun, and continue to scale up our manufacturing effort to ensure a support for global supply. We have generated promising data for BNT311 and are continuing to advance the rest of our oncology pipeline toward multiple late-stage trials in 2021, and we expect to initiate our first-in-human trials for two cell therapies. This includes BNT211, our CARVac program targeting claudin 6, with claudin 6-specific CAR-T cell therapy in refractory advanced solid cancers; and BNT211, our personalized neoantigen targeted T cell therapy in patients, who are refractory or unresponsive to checkpoint inhibitor treatment. We are also very capitalized to deliver on our commercial, operational, and pipeline milestones. Our vision has always been to bring novel therapies to patients most in need. The development of a vaccine to prevent COVID-19 would be a remarkable accomplishment of our vision. We truly believe that if we are successful, we will have an extraordinary opportunity not only to impact this pandemic on a global scale but have also the opportunity to accelerate our long-term vision to build the next-generation immunotherapy pharmaceutical company. We thank our shareholders and partners for their trust and support, and we'll now open up the floor for questions. Operator?

Thank you. [Operator Instructions] Your first question comes from the line of Tazeen Ahmad from Bank of America.

Hi, good morning, and good afternoon. Thanks so much for taking my questions. As it relates to a couple of data follow-ups for COVID, I wanted to get a little bit more color. So for pediatric patients, I know that you had opened up your study to younger patients. I think that occurred maybe in October. I am just wondering if any pediatric patients have been enrolled and are being studied with the vaccine at the moment? And what would be the longer-term needs in order to get a label that would be inclusive of pediatric patients? And then my second question is as it relates to durability of response, based on what you know now about the profile of the vaccine, do you think booster shots will be needed? I think for modeling purposes, most of us are assuming that after the two-dose regimen, folks won't have to be revaccinated, but we'd like to know if that isn't a proper assumption to be making, or is it too early to know? Thanks.

Yes. Thank you for the question. So the first question was about pediatric patients. In the ongoing global study, we have included smaller cohorts of pediatric patients, cohort of 16- to 17-year-old adolescents, and a smaller cohort of a 12- to 15-year-old subjects. And so these are, as I said, smaller cohorts. We are currently discussing with regulators, with the FDA and EMA, our pediatric plan, including which types of studies, in which sequence, in which age strata of pediatric populations are required. At this point, we cannot make any comments, but we will be able to do so soon once these agreements have been accomplished. The second question was durability. Ugur, do you want to take this one or...

Yes, I can take this. So we do not yet have robust data for predicting the durability of immune responses based on our observations that we have for up to three months after second dose. We believe that the durability of neutralizing antibody responses would reach at least one year. And we already know from prior studies that messenger RNA vaccines are suitable for prime-boost approaches. So that means we will generate data in the upcoming six to nine months to also evaluate such protocols and identify an appropriate schedule for optimal boost protocols.

And if I could just ask one last question. How important do you think it is to be able to come up with a formulation where it's just one shot for patients as opposed to the current two because there are patients that are not -- it might be a small number, but there are patients that are not coming back for the second dose. And do you think that that could be something that in the commercial setting could be somewhat rate-limiting? Thank you.

Yes. So the one-dose vaccine is quick-fire to key information. First of all, we do not have at the moment the biomarker correlate for protection in humans. It is well established at high neutralizing antibody titers required for preventing infection. And T cells are required for preventing disease. And it is also now established that given the high affinity of the SARS-CoV-2 spike protein to the human receptor that very high antibody concentrations are required to translate this into strong neutralizing antibody titers. And so at the moment, we have to assume that two injections -- two doses of vaccine are needed to have an effective prevention from infection. We will learn in the next six to 12 months whether also lower titers, neutralizing antibody titers might be sufficient to come up or to continue with a schedule, which have just a single injection.

Thank you. Your next question comes from the line of Cory Kasimov of JP Morgan.

Good morning, everyone. First off, big congrats, and a thank you for that matter for all the intense efforts and the great result with your COVID vaccine. So my first question is on manufacturing? And how we should think about the scale-up process of going from roughly producing 50 million doses by the end of this year to about 1.3 billion by the end of next year. Is it best to assume something of a linear trajectory here, or is it a process that's likely to be a little bit more back-end loaded? And then I have a follow-up.

Sierk, would you like to take the question?

Yes. I'm happy to take it, yes. Thank you, Cory. I think this is more like a step-wise approach, actually. So you have like Pfizer ramping up their network, and we are ramping up our network, so the European BioNTech network. And I think it will come in tranches. So basically with Puurs coming up, the facility of Pfizer in Belgium, with finishing drug product and then adding our facility, it will be rather like step changes. So I don't think that you would expect lower volumes that go higher, evenly. I think you would have like bigger chunks in Q1 coming up and then another chunk in Q2 coming up actually. So then you have -- I mean, the bottlenecks will be moving all the time. So when you have like a drug substance, which will come up and then you will debottleneck a drug product, and then you have like various finish capacities. And I think eventually, if Marburg is really up and running and stable, potentially, yes, upside for collaboration in the end. But yes, step-wise, the biggest step-ups that come away from the 50 million would probably be in Q1.

And then on the logistics front, do you expect that in time, it will be possible to improve upon the current cold chain storage that's required for BNT162? Could you just talk about the work that's going on there?

Sean, would you like to take the question?

Yes, sure. Cory, of course, we're not stopping the development of the vaccine, and we're looking at formulations that are more or less, say, ordinary course of the business use. We have programs running to do that. And if we're successful in generating the data in those programs, we will, of course, be launching line extensions that are more, as I said, ordinary course of business, and primary-care physicians can stick them in the fridge for a longer period of time.

Thank you. Your next question comes from the line of Daina Graybosch from SVB.

Thank you for the question and thank you for all the work that you're doing, and congratulations. I can't say that enough. I have many, many questions, but I'll focus perhaps on two. The first is, do you believe the efficacy you've seen greater than 90% prevention of BNT162 suggests that all vaccines against the spike protein will be effective? Or do you believe there's some unique elements to your platform that potentially could be differentiating short-term and long-term? And then second question is, when do you think we'll learn about the potential protection against infection and transmission? We've seen in the protocol that you're looking at exploratory serology at one and six months. Will we be able to see anything at one month already at the EUA filing? Or do you think we'll need to wait for six months to understand that? And then I guess, finally, on that, do you believe that this vaccine will protect against infection as well? Thank you.

Thank you, Daina. So I will start with the easier question, which is first one. So first of all, I think the good message for mankind is that we now understand that infection, COVID-19 infection can be indeed prevented by a vaccine. And of course, we believe that our vaccine will not be the only vaccine, which accomplishes that. There are a number of vaccine trials, Phase 3 vaccine trials ongoing. With regard to the efficacy, we have to understand, and this will come in the next six to 12 months, what caused the prevention rate? Is it the neutralizing antibody titer? Is it the T cell response? Is it the combination of both? So we expect that other vaccines will also be effective, but we, of course, don't know how effective these vaccine trials will be. And maybe depending on the efficacy of this different vaccine trials, we can learn more about the mode of action of prevention of COVID-19. Currently, a number of different publications hint that neutralizing antibody titers are required, of course, to prevent entry of the virus into cells. But it is also well established that people with preexisting T cell responses have a much better prognosis, clinical prognosis than infected with COVID-19. So we have to see and how these immune responses correlate with prevention. With regard to in addition of infection, this is difficult to assess. This would require a completely different approach for clinical testing, meaning that we would also need to test subjects without having any symptoms. This is currently not doable based on the complexity of such trials, but we might get information in an indirect fashion from our ongoing trial. I expect this type of information will not be solid before the time frame of six to 12 months.

Thank you. Your next question comes from the line of Navin Jacob from UBS.

Thank you so much for taking the question and congrats to the whole BioNTech team for the very hard work and amazing results. Two, if I may, on 162b2, or the COVID program, and two, if I may, on GEN1046. On the COVID program, wondering if you could share with us how many severe cases of COVID-19 were seen in the placebo arm, I am presuming at least five because that was, I believe, the requirement per the guidelines? And then secondly, wondering if you could provide an update on your self-amplifying program and how that technology contrasts with the Arcturus' self-amplifying vaccine? And then if I could follow-up on GEN1046 after.

Yes. The first part of the question with regard to further specific information. So we can't provide at the moment on this type of information because the extent of information that we got from the data monitoring committee is extremely limited to ensure the integrity of the primary endpoint, which is expected in about two to three weeks from now. And so we expect that in three weeks, we will be able to answer this question and many other questions, for example, also the question, how is the protection rate in the elderly as compared to the younger population. With regard to our self-amplifying vaccine approach, we did prioritize this vaccine trial. Our self-amplifying messenger RNA trial is still in the dose escalation. We reached a dose of 30 micrograms at the moment and further dose escalation is ongoing. We will be able to report immunogenicity data. Initially, we expected to report initial immunogenicity data end of October. This will become now more beginning next year.

Thank you. And then on GEN1046, if I may, but wondering if -- and I know you touched upon this slightly, but the mechanistic rationale for seeing lower liver tox with 1046 versus perhaps other 4-1BB molecules? And also, I am sorry if I missed this, but what dose was selected for dose expansion for 1046 or 311 in non-small cell, please?

So the first question, the reason for reduced liver toxicity is the conditional binding mechanism to 4-1BB, which means that the antibody has to be bound to PD-L1 in order to be able to bind to 4-1BB by a confirmational change. The second question was what our recommended Phase 2 dose is. This will be 100 milligrams.

Thank you. Your next question comes from the line of Akash Tewari from Wolfe Research.

Hey, thanks so much for taking my questions, and thanks again for all of your hard work on the vaccine front. A few, if I may. I just wanted to confirm, I think on the call, you mentioned that titer levels were similar to natural infection. Was that similar or were they multiple folds higher, like you've seen in your previous data? And did you see any level of titer corresponding to efficacy based on the 94 patients you've looked at so far? And I guess I'll ask this a little bluntly. What's the split of U.S. and ex U.S. dose allocation? And if someone were to say, Pfizer, BioNTech could sell the remaining 700 million dose allocation at $20 a dose, that could be a reasonable target for 2021, how would you respond to that assertion? And then lastly, in your updated protocol for the COVID vaccine, we saw that you introduced a new manufacturing process in order to scale up. What are the differences between your old manufacturing process and the new one? And what are the kind of the FDA and European requirements in terms of demonstrating equivalents using those two manufacturing processes? Thank you.

This is multiple questions. Let me try to address most of them except for the commercial aspect. Maybe Ryan can start with the question related to the supply of vaccine. Ryan?

Yes, sure. So Akash, the U.S. versus ex U.S. and so the U.S., it's a 100 million order with an option for an additional 500 million. And so it's about a fifth of -- or a sixth, actually, of over 570 million dose commitment that we mentioned. Of course, the option would take it much higher than that to as high as 600 million doses. So you can see the bookings there, one-sixth to about half. In terms of your average price question, at this point, we can't provide an average price. What we can say is that we've indicated that the price for the U.S. for the first 100 million doses was $19.50 per dose for the first 100 million doses. And you can think about that as a benchmark for how we would price the vaccine to the developed world for similar volumes. So we do expect prices to differ by country, by region. But for the developed world, I think that's the key benchmark. And you can see from the dose numbers that we've indicated here in the presentation today that most of those, at least committed orders, are in the developed world, but we are, as mentioned, also looking to supply the developing world. So it's going to be an average across those.

So I can continue with the questions related to the vaccine. So the neutralizing antibody titers, indeed, are at least two to threefold higher than the titers that we have observed in the convalescent sera. I think the note that level of titers are in the same level is only true for sub-proportion, proportion of sera from hospitalized patients. The second question related to the manufacturing process. So the manufacturing process has been scaled up during the development, including changes in the way how the messenger RNA is purified to ensure that we can increase the batch side. These manufacturing changes did not result in any change of the release criteria. So the product remains in the specification of the original product. And so far, the comparability data that have been generated show that both processes are comparable. We have submitted this data to FDA, to EMA, and are currently in discussion with both authorities to ensure that this manufacturing change is accepted and discuss potential additional studies to be performed. With regard to the split, we can't provide any information because the information that we obtained from the data monitoring committee is extremely limited. And essentially, each piece of information is already in the press release. So additional information will come up with the final readout in about three weeks.

Thank you. Your next question comes from the line of Arlinda Lee from Canaccord.

Hi, guys. Congratulations on the impressive efficacy and thank you for the tremendous effort to get here so quickly. I had a few questions about 162 and then also 311. I guess I'm curious on the dose guidance. The 1.3 billion doses for next year, that guidance doesn't seem to have changed. So I'm wondering if the Marburg facility is included in that. And then on the logistics of delivery, there's some debate in the U.S. about allocations. And I'm curious when you deliver the 100 million doses to the U.S., are you delivering to the sites based on where they tell you to go, or how does that work? And then on 4-1BB with the conditional activity, I am wondering, one, how did you decide on the expansion cohorts? And if that conditional activity is something that you're planning to work into some of your other programs as well? Thank you.

Ugur, do you want to take the 4-1BB part? And then I'll take the guidance.

So the Phase 1 trial that we are currently executing had different patient populations and with different indications. And based on the observations that we made in this patient population and based on the mode of action of the compound, we decided to select indications, second-line indications that mean checkpoint responsive indications with patients who failed prior checkpoints blockade. That was one rationale because our expectation is that the dual body might test significant activity even in patients who did not respond or failed checkpoint blockade treatment or progressed upon successful checkpoint blockade treatment. The second group of patient groups or clinical indications of first-line patients and where particularly clinical indications in which checkpoint blockade is already approved, but effect size is still limited like non-small cell lung cancer and triple-negative breast cancer are currently discussed as expansion cohort. And this expansion cohort intended to guide us in a past session to control randomized Phase 2, Phase 3 trials.

Yes. And on the first part of your question, the 1.3 billion, I think it's important to remember that that's a supply capacity number, cumulative supply by the end of 2021. And you're correct that we haven't updated the guidance since the acquisition of Marburg, the Marburg site. As Sierk mentioned, the Marburg site will really accelerate our production ramp-up over the course of 2021, starting in the first half of the year. And the extra volumes will support both the Pfizer alliance and also the Fosun alliance. And it's important to remember there, too, that the 1.3 billion guidance number for supply was a Pfizer-BioNTech number, and we have not yet guided specifically to China market opportunity. So that would be on top of the 1.3 billion number.

Thank you. And then on the logistics of delivery, I'm just curious about how you're going to deliver it to the U.S. and whether you're going to give it to the sites, in particular, as U.S. direct. Or how does that work?

Yes. So the logistics plan for the U.S. is we're going to have a number of centralized depots, followed by the more diffuse distribution points that we alluded to in the presentation. So centralized depots and then spread out throughout the country, distribution sites, including high volume and also lower volume sites. So distribution in the United States will be executed by Pfizer.

Thank you. Your next question comes from the line of Zhiqiang Shu, Berenberg.

Hi. Good morning. Thanks for taking my questions. And I want to add my congrats as well to the team. It's definitely a critical moment for mRNA and for BioNTech. A few questions on the COVID-19 vaccine. So the first one is I'd like to know what was the initial rationale for the protocol change from 32 cases to 62 cases for the first interim analysis? And then secondly, I assume that once you reach the final efficacy analysis, you would unblind the trial. I wonder how would you reassure fair assessment of long-term protection and safety once you unblind the trial? And then also, I'd like to understand the -- for booking sales, I recall there are a few countries that you would book the sales for a few European countries. Would you disclose those countries at this time? And then finally, for the oncology, I have a quick question on BNT111 plus PD-1 study you mentioned in your press release that you would conduct additional trials for registration. Can you provide more color on that? Why do you think that will be the case? And then can you remind us the -- to randomize the arms for that trial, BNT111 plus PD-1? Thanks very much.

So let's start with the first question to the rationale for the protocol change. So when we decided the protocol, this was sometime in July, it was not clear how the pandemic situation, the continuity evolves. And one scenario was that the number of infections, the infection rate could drop, providing a difficulty to collect sufficient cases in 2020. Therefore, we have included an early interim analysis arm with 32 cases. But what happened is contrary, instead of dropping of the infection rate, the infection rate went up, as we have seen in the last week dramatically. And therefore, we realized that the time points between 32 cases and 62 cases are so close to each other that it does not make sense to do the readout with 32 cases. We went back to the FDA and requested if we can drop the 32 cases, the FDA after evaluating the protocol change accepted that. The whole process took about one week. And when we started evaluation of the number of cases, we have passed 62 cases and came up with 94 cases. So that's the background for the protocol change. The second question is related to BNT111. So we plan to submit our randomized Phase 2 protocol, resubmit our randomized Phase 2 protocol for BNT111 with three arms, with one arm combining entire PD-1 with BNT111, one arm of anti-PD-1 alone, and another calibrator arm vaccine alone. And with the feedback from the FDA, the feedback from the FDA was additional request that the clinical trial protocol for registrational trial would require a potency assay. And we got additional questions to that. The questions are addressed, and we submitted now the modified protocol, including the information for the potency assay, and expect feedback from the FDA in the coming 30 days.

Yes. And on the booking sales question, we intend to book sales in Germany. We're still assessing the overall accounting treatment, but you can assume Germany where we're going to commercialize. And also, we'll expect our profit share from our partners, Pfizer and Fosun, also to flow through the P&L, of course. And remember, that's a gross profit share. I don't know, Sierk, if you want to add to that.

Yes, that's correct. I think what we are evaluating right now is because we have to line on the accounting with Pfizer because they're under U.S. GAAP, and we are IFRS. Although similar, especially on this revenue recognition, there are a couple of subtle differences, which we are working out right now. And once we know what piece flows through which line item actually on the P&L, we will give you guidance actually that you can actually model this out a little bit more subtly.

Great. And then one question. I asked about the assessment of long-term protection if the trial is unblinded. Can you comment on that as well? Thank you.

Yes. So the key reason for potential unblinding, of course, is that with this efficacy, of course, at a certain time point, we have to offer also for the placebo group the vaccine. And we will continue to monitor the new infections in the vaccine arm, and this might give us indirect evidence based also by comparison of epidemiological data how this long-term protection would evolve. And so we are confident that the two years follow-up, including a follow-up of neutralizing antibody titers, in a subgroup of subjects would allow us to give an estimate for long-term protection.

Thank you. We have two more questions. And your next one comes from the line of Daniel Wendorff from Commerzbank.

Good afternoon and thanks for taking my questions. Also a big congratulations from my side on this achievement. Two questions on BNT162, if I may. The first one, on the interim analysis. Can you talk about the phasing of the observed COVID-19 cases in the vaccine arm? Did that occur rather at the beginning of the trial or more toward the end, if you have this data at all already? And my second question would be on the gross profit per dose, basically. So assuming what you said on potential pricing assumptions for modeling purposes, how should we think about the gross profit per dose? Is there any kind of guidance you can give us, in general, putting aside how you book eventually then the gross profit share from Pfizer potentially? Thank you.

Yes. Thank you for the questions. I can quickly answer the first one. As Ugur has pointed out, the interim analysis was a very lean one. It was really about assessing the primary endpoint. And in particular, we, as the blinded ones have not any further information. We have to wait a couple of weeks so that the final analysis and all the prespecified assessments, including also better understanding of the kinetics of when cases evolved, is available for us. For the second, I guess I have to defer to Ryan or Sierk.

Yes, sure. I can take it. Unfortunately, Daniel, we can't provide an updated gross margin guidance at this point. It's going to depend on, of course, mix ultimately in sales, but we will plan to provide a further update as we get closer to commercialization.

Thank you. And your final question today comes from the line of Olga Smolentseva from Bryan Garnier.

Good afternoon and many congratulations and many, many thanks on all the hard work. I have a few questions, one on COVID vaccine. Thinking about potential upcoming EUA submission, would you consider to file right after sufficient safety data with efficacy with basically efficacy data available at that point? Or would you wait for the full readout with 164 events?

Thank you for the question. So this is really very agency-specific. And we have been in close interaction with all agencies, including FDA and EMA and MHRA, and others, from the very beginning and have the respective specifications, which type of data they want to see. With regard to EMA, for example, you may know that we have started actually a rolling submission some time ago and are complementing that in subsequent roles for the FDA, for EUA approval, whereas, for example, key safety endpoints that FDA wants to see. And we are adhering to those requests of respective agencies with regard to when and what exactly to file.

Thank you. And maybe when might we expect additional stability data? And maybe could you speculate what do you expect to see, like potential stability at minus 20 or a longer stability at refrigerated temperatures, etc.?

Yes. So a number of stability studies are ongoing. We have stability studies, including minus 20, minus 40 degrees, as well as stability studies to support extended storage at 2 to 8 degrees. So we will have continuous updates on the stability studies, expecting the next update sometime in mid-December.

Great. Thank you. And just a quick one on BNT311, PD-L1x4-1BB specific. For the responded patients, do you have any visibility on the PD-L1 status? And for those that received prior checkpoint inhibitors, if they were considered sort of non-responders or rather developed quiet resistance.

So we had several cases where patients did respond at all to initial checkpoint blockade treatment and progressed under treatment. We so far do not have a correlation between the objective responses that we have observed and PD-L1 status of the original tumor.

Thank you. That was your final question.

Thank you for joining the call today. We look forward to speaking to you in future. Thank you and have a nice day. Bye-bye.

Thank you.

Thank you.

Ladies and gentlemen, this concludes your call for today. Thank you all for participating and you may now disconnect.