BioNTech SE (BNTX) Q1 2021 Earnings Report, Transcript and Summary

Thank you for standing by, and welcome to BioNTech First 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 Instructions]. I must advise this call is being recorded today, Monday, May 10, 2021. And I would now like to hand the call 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 first 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, BioNTech's support to combat COVID-19, the collaboration between BioNTech and Pfizer regarding a COVID-19 vaccine, our expectations regarding the potential characteristics of BNT162b2 in our ongoing trials and/or in commercial use based on data observations to date, including real world data gathered; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional read-out on trial data of BNT162b2 in ongoing trials; the timing for submission of data for or receipt of any marketing approval or emergency use authorization; our contemplated shipping and storage plan [Technical Difficulty] ability of BioNTech to supply the quantities of BNT162 to support clinical development; and if approved, market demand including our production estimates and targets for 2021 and 2022; the planned next steps in our pipeline programs and specifically including, but not limited to, statements regarding plans to initiate clinical trials of our product candidates or expansion in Southeast Asia; expectations for data announcements with respect to our clinical trials; our current estimated COVID-19 vaccine revenues based on current contract supply orders; or projected expenses, capital expenditures and tax rate for 2021; our target vaccine production capacity for 2021 and 2022; our recorded vaccine revenue, which are subject to numerous estimates as more fully described in our annual report on Form 20-F and quarterly report for the three months ended March 31, 2021 and our risk described in our filings made with the US Securities and Exchange Commission, including our most recent annual report on Form 20-F. 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 today shared today during this conference call and webcast. Also please note that slide 3 provides details and important safety information regarding our recently launched COVID-19 vaccine. Slide 4. On the call from BioNTech's 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. I'll now hand the call over to Ugur Sahin, BioNTech's, CEO.

Good morning and good afternoon. And thank you to everyone joining the call today. I'm delighted to discuss our continued progress in the first quarter, leaving us well positioned to achieve the milestone we had planned for this year and beyond. Slide 5. During our last quarterly update, only six weeks ago, we detailed BioNTech's transformation into a fully integrated biopharmaceutical company within a remarkable timeframe as we rose to the challenge of a global pandemic. We have stayed true to our vision of harnessing the full potential of the immune system to overcome the therapeutic challenges of today by combining excellence in immunology and innovative technology. Our core competencies and resources established over the last decade have validated our success in developing the first approved mRNA vaccine against COVID-19. The success has become the foundation of our exciting and ambitious journey to change treatment paradigms in a range of disease areas. Our robust pipeline with more than 20 product candidates addressing oncology and infectious diseases and beyond reflects this ambition. We are in a quite unique position to strategically invest cash flow from our COVID-19 vaccine into further maturing the company, deliver multiple product launches over the next five years. Slide 6. Our global goal is to build a 21st century immunotherapy powerhouse. Firstly, we continue to increase our global footprint with new offices beyond our subsidiary in the United States. This includes our commercial subsidiary in Germany, in Turkey, and planned regional headquarters in Singapore that we will discuss later in the call. Second, we are expanding our integrated infrastructure for strategic investment in scientific and technological innovation. This is in the heart of everything we do. These investments spanning clinical, commercial, manufacturing excellence, including digital capabilities, will support future product launches. Our success is driven by people. Therefore, attracting and retaining top talent remains a crucial imperative for us. Lastly, we see a tremendous opportunity as we advance our robust pipeline in infectious diseases and oncology and expand to new therapeutic areas, accelerated by our vaccine revenue. Our pipeline currently consists of 14 products in 15 ongoing clinical trials. Building on compelling data, we are poised to initiate multiple potentially registrational studies and first-in-human products in 2021. Our dynamic and rich internal R&D efforts will be complemented with strategic in-licensing. Side 7. Slide 7 highlights key achievements since our last update on March 30. With respect to our oncology pipeline, we have started three first-in-human oncology trials in 2021. These include two cell therapies , namely BNT211, our CARVac program, and BNT221, our neoantigen targeting T-cell therapies. The third is our first RiboCytokine program featuring an optimized interleukin-2 variant. Özlem will detail this program in her remarks. With respect to our COVID-19 vaccine, I remain delighted by the exceptional excellence of our team, along with our partner Pfizer, has exhibited. To date, we've delivered more than 450 million doses of our COVID vaccine to 91 countries and territories worldwide. For 2021, the number of contracted doses has increased to about 1.8 billion, with first contracts in place for 2022 and beyond. Last week, we announced together with Pfizer the signing of a memorandum of understanding with the International Olympic Committee to donate doses of our COVID-19 vaccine to vaccinate athletes and their delegations participating in Olympic and Paralympic Games, which are scheduled to take place in Tokyo in July 2021. The strong execution across our entire organization, along with our partner Pfizer, led to the recognition of €2 billion in COVID-19 vaccine revenue in our first quarter of COVID-19 commercialization. Our COVID-19 vaccine continues to demonstrate robust clinical results. Since our last call, we disclosed two additional significant positive clinical updates, including top line results from our Phase III trial that confirm trial efficacy with no serious safety concerns through up to six months following the second dose. In this analysis, 927 confirmed symptomatic cases of COVID-19, BNT162b2 demonstrated 91.3% vaccine efficacy. The vaccine was 100% effective in preventing severe disease as defined by the US CDC and 95.3% effective in preventing severe disease as defined by the FDA. The data also showed the vaccine was highly effective in preventing COVID-19 cases in South Africa where B1.351 linage is prevalent. We anticipate publication in peer-reviewed journal and plan to submit this data to regulators in the upcoming weeks. They also announced positive top line data of our US pivotal study of 2,260 adolescents. 12 to 15 years of age, demonstrating 100% efficacy in participants with or without prior SARS-CoV-2 infection. BNT162b2 was well tolerated, demonstrating strong immunogenicity with SARS-CoV-2 neutralizing antibody titer one month after the second dose. We remain focused on six key levers to expand our COVID-19 vaccine reach globally and across different demographics as shown on slide 8. We are now targeting a manufacturing capacity to reach up to 3 billion doses by the end of 2021 and more than 3 billion doses in 2022. The first shipments from our Marburg facility were delivered mid-April, a remarkable accomplishment for BioNTech manufacturing scaleup. In Singapore, we plan to establish a regional headquarter that will also include highly automated end-to-end mRNA manufacturing facility. We continue to [indiscernible] vaccines label. We expect to hear back shortly from the FDA on our applications for expanded emergency use authorization for our COVID-19 vaccine to include individuals 12 to 15 years of age. We also expect feedback from EMA on our submitted label expansion for the same age group. As announced last week, as Canada has authorized the use of BNT162b2 in that age group already. Ongoing trials include a global Phase II/III in healthy pregnant women and a study in children 6 months to 11 years of age. We expect to announce safety data from those studies in the third and fourth quarter 2021. We are determined to contribute to vaccine access globally and our vaccine has been approved for emergency or temporary use or granted conditional marketing authorization in more than 70 countries and regions, including emergency use listing from the WHO in January. In addition, I would highlight that the regulatory submission for Mainland China is now underway in collaboration with our partner Fosun. For broadened and decentralized vaccine access, we initiated the all-in biologic license application in the United States for BNT162b2. We will seek full approval of our vaccine in countries where regulatory submissions have been made and emergency use authorization or equivalent are currently in place. Both the FDA and EMA have updated our label with two weeks' storage and transport at minus 25 to minus 50 degree Celsius. Recently, we submitted new stability data to the FDA to broaden our label to standard refrigerator temperature, that means 2 to 8 degrees of Celsius for up to four weeks. We are also developing ready to use and lyophilized formulations that improve thermal stability profile to reduce dependency on cold chain production. We have initiated a trial to evaluate a lyophilized and ready-to-use formulation with data expected in the third quarter. Our understanding of SARS-CoV-2 is evolving as new data is generated and we understand that immunity may wane over time and that new variants emerge. I do believe a booster will be of high value to establish full immunity. We do not know yet then how frequently this will be needed. Also, there is currently no evidence that an adaptation of our current vaccine against any of the circulating variants is necessary and we continue to monitor real world efficacy against emerging variants. However, we want to learn and preemptively prepare today to respond fast in case a third dose of strain adaptation will be required in future. Slide 9, to this aim, we have developed a comprehensive strategy that uses the South African variant as a prototype for potentially emerging [indiscernible]. In subjects who have been vaccinated with two doses of BNT162b2, we evaluate a third dose of either BNT162b2 or the BNT162b2 South African variant version. The trial will also enroll a group of BNT162b2 naive participants who will receive two doses of the BNT162b2 South African variant version. The data will inform us about safety and additional boosterability of the immune response and effect of this additional boosters on immunity against circulating virus and potential new emerging SARS-CoV-2 variants. First data expected in the second quarter of 2021. This effort will also provide a blueprint for a trial design, regulatory pathway and platform [indiscernible] of the manufacturing process for each future variant. I will now turn over to Sean to provide an update on our COVID-19 order book and manufacturing capacity. Sean?

Thank you, Ugur. Great to be with everyone today. Moving to slide 10 for an update on the distribution progress of our vaccine. We now have contracted orders for approximately 1.8 billion doses in 2021, which includes increased orders from the EU and UK and a number of developing countries. Multi-year contracts through 2022 and beyond are being negotiated with a number of countries around the world, demonstrating that there will be demand for our vaccine in the post-pandemic market. We have reached an agreement with Israel to supply millions of doses in 2022 and with Canada to supply up to 125 million doses in 2022 and 2023, with options to supply up to 60 million additional doses in 2024. We look forward to expanding supply to additional geographies beyond those shown here. Turning our attention to slide 11. We are aiming to increase our supply capacity to up to 3 billion doses in 2021, and we expect to be able to manufacture more than 3 billion doses in 2022. This increase was driven by the critical need that remains in many parts of the world requiring access to vaccine supply, as well as vaccinations. Looking at BioNTech's manufacturing network, I would like to point out that BioNTech has manufactured more than 50% of the drug substance rolled out to date worldwide. Our Marburg facility has made significant progress. We have established mRNA manufacturing at the Marburg site in less than six months, including EMA's approval of the manufacturing of our COVID-19 vaccine product at the facility in late March. As Ugur noted, the first batches of vaccine from the Marburg site were delivered in mid-April, which is truly a remarkable achievement. With the Marburg site fully operational, BioNTech's annual vaccine manufacturing capacity will be approximately 1 billion doses on an annual runway rate. Beyond COVID-19, this large in-house manufacturing capability position us for future success with additional pipeline products that we anticipate launching in the coming years. I now turn the call over to Özlem to provide an update on our oncology pipeline. Özlem Türeci: Thank you, Sean. I will provide updates on selected on immunooncology programs which have recently advanced in clinical stage, of which we expect to reach significant milestones this year. For further details on other programs, please refer to our annual report which was filed with the US Securities Exchange Commission on March 30 and our quarterly update which will be filed with the SEC today. Despite the undeniable impact of the COVID-19 pandemic on our clinical operations, we expect to present several data sets and initiate multiple new trials. Slide 14 provides a snapshot of our immunooncology platform across the distinct drug classes. Our pipeline covers a broad range of immune therapy approaches that leverage powerful mechanisms of action and a diverse array of novel targets to address the unique molecular signature of each patient's tumor. We believe that harnessing complementary modes of action increases the likelihood of therapeutic success and unlock a larger potential market. Combination therapies of drugs that work synergistically are expected to be particularly useful for therapy-resistant tumor types, for which the chemotherapy and targeted approaches has failed. Our platforms are being developed to address these limitations and provide a pipeline of potentially combinable products, with complementary and synergistic immune modulatory modes of action. CARVac is one of our opportunities already in clinical testing. It combines our FixVac immunotherapy with our novel CAR-T therapies. Our pipeline highlights several other product candidates with a potential for synergistic combinations that are currently in clinical trials. Our most advanced oncology programs, including upcoming near-term milestones, are shown on slide 14. For our FixVac product candidate BNT111 and BNT113, we expect to start Phase II trials soon. The BNT111 is for the treatment of advanced melanoma and I will detail further momentarily. BNT113, our mRNA vaccine encoding E6 and E7 proteins of human papilloma virus 16 will be evaluated in combination with pembrolizumab versus pembrolizumab alone as a first line treatment in patients with unresectable recurrent or metastatic HPV16 positive head and neck squamous cell carcinoma expressing PD-L1. For BNT122, our autogene cevumeran for individualized neoantigen specific immunotherapy, partnered with Roche Genentech, the Phase II trial in first line treatment of metastatic melanoma and the Phase I basket trial in solid tumor remain ongoing. Based on promising data seen for iNeST, we decided to move into adjuvant treatment settings, starting with colorectal cancer. Due to slow enrollment caused by the ongoing pandemic, we are updating our guidance and expect to dose the first patient in the second half of this year in a randomized Phase II trial evaluating BNT122 in circulating tumor, DNA positive, surgically resected stage 2 high risk or stage 3 colorectal cancer patients. Together with Genentech, we are evaluating other options for treating early stage cancer patients with BNT122. Then there's our next generation checkpoint immune modulator program, which is partnered with Genmab. We expect to provide a data update in the second half of 2021 for the ongoing Phase I/II trial of BNT311, which targets PD-L1 and 4-1BB. We remain very encouraged by the results seen to date and believe this product has significant potential across multiple oncology indications, given the unmet need for improved checkpoint immunotherapies. We also plan to present data in the second half of 2021 from the ongoing Phase I/II trial of BNT312, which conditionally targets CD40 and 4-1BB. Slide 15 provides an overview of our next wave oncology assets, including six programs across four different technology platforms that have the potential to advance innovation beyond current boundaries. Three of these six highly innovative programs are in preclinical stage. Our first CARVac product candidate has entered clinical testing and we will be presenting first early data for BNT211 at the ongoing [indiscernible] 2021 meeting. Also, the first product from our NEOSTIM T cell therapy program, BNT221, has entered clinical testing. The first patient was dosed in a Phase I trial in April. I will discuss both cell therapy programs in greater detail shortly. On last quarter call, we also noted that, for BNT151, our first RiboCytokine program, encoding a modified IL-2, the first patient was dosed in a Phase I trial in solid tumors in February, a Phase I trial of BNT152, BNT153, our IL-2, IL-7 RiboCytokine combination in multiple solid tumors is expected to also start this year, as are Phase I trials in multiple solid tumors for BNT141 and BNT142, our first RiboMabs programs. Moving to slide 16. Our lead FixVac product candidate, BNT111, will soon be advancing into a randomized Phase II trials. This intravenous vaccine encodes six sets of four cancer specific antigens expressed in our mRNA backbone, optimized for immunogenicity and delivered in our RNA lipoplex formulation. The four antigens encoded in BNT111 are common to about 95% of all melanoma patients. As previously published in Nature, BNT111 in monotherapy and even more so in combination with anti-PD-1 has shown promising data in CPI experienced patients with advanced melanoma in our Phase I trial. Tolerable safety, durable objective responses in checkpoint inhibitor experienced patients with evaluable disease at baseline and high magnitude and persistent CD4 and CD8 T cell responses have been observed. We believe that these strong positive data provide compelling support for advancement of BNT111 in combination with anti-PD-1 into a Phase II study in a high medical need setting, namely patients with anti-PD-1 refractory or relapsed unresectable stage 3 or 4 melanoma. This global study is a collaboration with Regeneron and is outlined on slide 17. 120 patients will be randomized 2 to 1 to 1 into three treatment arms evaluating BNT111 plus Regeneron's cemiplimab and each drug as a monotherapy. The primary endpoint is overall response rate and the BNT111 plus cemiplimab arm. Now moving to slide 18. BNT211 is BioNTech's first clinical stage chimeric antigen receptor product candidate. BNT211 targets the tumor-specific antigen CLDN6 and was developed in combination with a CAR-T cell amplifying RNA vaccine, short CARVac, in preclinical studies. In those studies, we demonstrated that CARVac treatment leads to in vivo expansion of adoptively transferred CART-T, resulting in increased persistence and superior functionality. BNT211 is expected to overcome CAR-T cell therapy limitations that temper efficacy in patients with solid tumors and thus limit widespread use of CAR-T cell therapies. CLDN6 is the target antigen for BNT211 and an ideal candidate for CAR-T cell therapy due to its absence in healthy adult tissues and its frequent expression in high medical need cancer. The ongoing Phase I/II trial is currently recruiting patients with CLDN6 positive relapsed or refractory advanced solid tumors, such as ovarian, testicular, lung, gastric and endometrial cancer. Slide 19 shows the trial design of the first-in-human Phase I/II trial of BNT211, evaluating the safety and efficacy of increasing dose levels of CLDN6 CAR-T cells, first without and then with CARVac. We have completed dose level one of the monotherapy arm with three patients and the next dose level is open for clearance. While the initial Phase I data from this trial is expected in the second half of this year, we are presenting some very early data from the trial at the ongoing [indiscernible] 2021 annual conference. Slide 20 shows preliminary data from the first dose cohort with three patients that were treated with a starting dose of CLDN6 CAR-T cell monotherapy. The underlying diseases were ovarian carcinoma, sarcoma and testicular carcinoma, all heavily pretreated. To date, we have not observed any acute toxicities or dose-limiting toxicities in these patients. All observed adverse events were transient and mild to moderate. We are very excited to report that an analysis of CLDN6 CAR-T cell magnitude and peripheral blood revealed detectable CAR-T cells with CAR-T engraftment in all patients. CAR-T cells in patient 1 declined after two weeks. For patient 3, a 90-fold expansion was seen. CAR-T cells of patient 2 expanded further, reaching a 700 fold expansion and a stable plateau from day 24 onwards. Tumor shrinkage was observed for this patient with 11% to 38% reductions in two or three target lesions six weeks after CAR-T cell transfer. So while early, the initial data from the trial are very encouraging and we look forward to presenting additional data in the second half of the year. Moving to slide 21. I'm excited to discuss our NEO-STIM BNT221 program. BNT221 is a fully personalized, neoantigen targeted adoptive T cell therapy candidate consisting of T cells targeting the most therapeutically relevant new antigens from each patient's tumor. We believe BNT221 offers several significant advantages as compared to TIL therapy, but T cells are derived from the patient's own peripheral blood which is advantageous with respect to accessibility since tumor acquisition may be limited. Cell therapy approaches typically rely on existing T cell repertoire in the tumor sample. We use the RECON bioinformatics platform to select the most therapeutically relevant neoantigen specific to each patient. We then custom manufacture new antigen peptides for each patient, which are used to activate and expand neoantigen specific T cells, recognizing patient-specific new antigens ex vivo. T cell responses from both [indiscernible] repertoire and the memory compartment are expanded. This results in CD4 and CD8 T cells against multiple tumor-specific targets, reducing risk of androgen escape and off-target toxicity. BNT221 induced T cell cultures directly recognized autologous patient tumor material, providing strong support for our approach. Many adoptive T cell therapy approaches are supported by high dose IL-2 to facilitate engraftment. BNT221 does not require IL-2 providing an important advantage in terms of product safety and tolerability. We believe this approach has potential to drive a robust and persistent antitumor response with improved safety and reduced antigen escape over other therapies. In April 2021, the first patient was dosed in a first-in-human Phase I dose escalation trial in metastatic melanoma refractory or unresponsive to checkpoint inhibitor. With this, I will now hand the call over to Sierk to provide an update on our financials.

Thank you, Özlem. I will summarize our financial results for the first quarter of 2021 as shown on slide 23. I will start with the total revenues which were estimated to be €2,048.4 million for the first quarter of 2021 compared to €27.7 million for the first quarter of 2020. Total revenues increased due to rapidly increasing the supply of our COVID-19 vaccine worldwide. As a reminder, under 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 24. Our first quarter 2021 commercial revenues include an amount of €1,751.9 million, comprising our share of gross profit from COVID-19 vaccine sales in the collaboration partners territory, which represents a net figure, as well as phase milestones. This figure is estimated based on preliminary data shared between Pfizer and us and may be subject to adjustments as we receive final data on input parameters, like sales and transfer prices. Changes in our share of the collaboration partners' gross profit would be recognized prospectively. Our COVID-19 vaccine commercial revenues also include €63.9 million in sales to our collaboration partners of products manufactured by us and €199.8 million of direct COVID-19 sales to customers in our territory. Now, returning back to slide 23 and moving to cost of sales, which were estimated to be €233.1 million for the first quarter of 2021 compared to €5.9 million for the first quarter of 2020. The increase was driven by the estimated €223.2 million cost of sales, which were recognized with respect to our COVID-19 vaccine sales and include Pfizer's share of gross profit earned by us. R&D expenses were €216.2 million for the first quarter of 2021 compared to €65.1 million for the comparable period in 2020. The increase was primarily due to an increase in R&D expenses related to our BNT162 program, recorded as purchased services with respect to those expenses which were initially incurred by Pfizer and subsequently charged to us under our collaboration agreement. As a reminder, [Technical Difficulty] costs are shared equally between the two companies. The increase was further driven by an increase in wages, benefits and Social Security expenses from increasing headcount and the recognition of expenses incurred under the new share-based payment arrangements. G&A expenses were €38.9 million for the first quarter of 2021 compared to €15.8 million for the comparable period in 2020. The increase was mainly due to the higher expenses for professional services, an increase in wages, benefits and Social Security expenses from increasing headcount, and the recognition of expenses incurred under the new share-based payment arrangements, as well as higher insurance premiums. Interim income taxes were €514.2 million for the first quarter of 2021 and were recognized using the estimated annual effective income tax rate of approximately 31%. For the first quarter of 2021, net profit was €1,128.1 million compared to €53.4 million net loss for the first quarter of 2020. As of March 31, 2021, cash and cash equivalents totaled €891.5 million. Moving to slide 25. We remain on track to achieve our 2021 financial outlook. Based on the current contracted supply orders of approximately 1.8 billion doses, we are providing estimated COVID-19 vaccine revenues to BioNTech of approximately €12.4 billion. This estimate reflects expected revenues from direct COVID-19 vaccine sales to customers in our territory, expected revenues from sales or collaboration partners, expected sales milestone payments from our collaboration partners and expected revenues related to our sales gross profit from COVID-19 vaccine sales in the collaboration partners' territories. We expect additional revenues related to further supply contracts for deliveries in 2021, with first contract in place for 2022 and beyond. In terms of guidance for the full-year 2021, we expect R&D expenses to incur in the range of €750 million to €850 million for the full-year 2021, reflecting our aspirations to broaden and accelerate our pipeline development, which we plan to ramp up especially in the second half of 2021. SG&A expenses are estimated to increase to up to €200 million. Capital expenditures for the year 2021 are expected to be in the range of €175 million to €225 million. And I would like to emphasize that all of these figures reflect our current base case projections. Finally, please note that, in terms of full year 2021 tax impact, we still expect German group corporate tax of approximately 31%. And with that, I turn the call to Ryan for an update on our corporate development activities and concluding remarks.

Thank you, Sierk. Turning to slide 27, we continued to expand our geographic footprint in the first quarter. In addition to establishing a subsidiary in Turkey to commercialize our COVID-19 vaccine, we are pleased to announce today plans to expand our footprint to Asia, with the establishment of a regional headquarters for Southeast Asia in Singapore. We plan to establish a fully integrated mRNA manufacturing facility in Singapore. It will be equipped to produce a range of novel mRNA vaccines and therapeutics for regional and even global supply and add resiliency to our global supply network. Based on our current plans, in partnership with the government of Singapore, facility will also form part of a rapid response capability for Southeast Asia to address future potential pandemic threats. Pending the necessary regulatory approvals, we plan to initiate construction of the manufacturing facility in 2021 and expect the site could be operational as early as 2023. So, with this planned expansion, we expect to have boots on the ground in Asia-Pacific by the end of this year, building on our existing footprint in Europe, United States and Turkey. Slide 28 highlights our expected pipeline milestones for the remainder of 2021. Since the start of the year, we have initiated three first-in-human clinical trials in oncology and we expect to initiate three more before the end of the year. We remain on track to start three potentially registrational Phase II trials with our wholly owned FixVac and iNeST programs this year. In infectious diseases, BNT161, our seasonal flu vaccine program partnered with Pfizer, is expected to enter a Phase I clinical trial in the third quarter of 2021. We are moving multiple other programs toward the clinic and plan to provide further updates on our infectious disease pipeline throughout the year. Finally, we expect data updates on up to five different programs in 2021, including our next generation checkpoint immunomodulators, BNT311 and BNT312, in the second half of the year. Turning to a few closing remarks on the next slide. We remain focused on ramping up supply of our COVID-19 vaccine with the goal of vaccinating more than 1 billion people this year and potentially even more in 2022. We believe we have a responsibility to supply large quantities of our vaccine throughout the world, including to the developing world and are working hard to make that happen. In parallel to executing against COVID-19, we will accelerate our pipeline development in our core therapeutic areas of immunooncology and infectious diseases. We intend to advance mRNA vaccines against a range of pathogens, building on our nine active preclinical programs. We will provide more details on some of these exciting programs over the course of this year. Finally, we intend to ramp up investment in our clinical, commercial and manufacturing infrastructure and teams as we transform BioNTech into a global biopharmaceutical company and prepare to bring next generation immunotherapy to people around the world. And with that, I'll conclude our presentation and open up the floor for questions.

[Operator Instructions]. And your first question comes from the line of Cory Kasimov from JP Morgan.

I'm curious what your views are on all the controversy last week on the patent waiver front and kind of what do you see as the potential impact here for BioNTech and kind of next steps you're waiting to hear on this topic? Thank you.

First of all, of course, we understand the importance of global distribution of our vaccine. And let me just shortly the summarize the status quo, which we have at the moment. We have delivered our vaccine to over more than 90 countries so far and we continue to support the global supply, including the lower and middle income countries. So, our capacity, our initial capacity for 2021 was in the range of 1.3 billion doses. We have now scaled the manufacturing capacity up to 3 billion doses in 2021. And more than 40% of the doses is expected to go to middle and low income countries. The only near-term solution that we see is really to ensure that we produce from the existing network. We have increased our existing manufacturing network and ensure that the vaccines which is produced in the United States and in Europe can be continuously delivered also to the lower income countries. And waving of IP would not increase short or medium term supply of the vaccine. So, the setting up of the manufacturing process is complex. It will take at least one year, not even more, to set up a new manufacturing and we don't see any value in waiving patents. We are, as we discussed this morning, already expanding our manufacturing network from Europe also to Asia. We are setting up manufacturing in Singapore. And we will also implement manufacturing in our JV in China. And we believe, together with the other vaccines, vaccines developed in the next 9 to 12 months, there will be more than enough vaccines produced and there is absolutely no need for waiving patents.

Your next question comes from Tazeen Ahmad from Bank of America.

For me, I wanted to just ask a little bit more about the booster. Ugur, are you thinking that the booster for the original formulation that you have manufactured for the Wuhan variant would be sufficient for future protection? Or do you think that the rate of change of each of the variants would necessitate any kind of change to the actual vaccine itself? And is it the latter? If you do have to modify the vaccine, how in any way does that change your rate of production plans for the need of boosters starting, let's say, next year and beyond?

At the moment, we don't see a need for changing our vaccine. As you know, we have done – in the last six months, we've evaluated more than 30 different variants and evaluated immune responses, antibody response induced with the virus type vaccine for neutralization and we see for the most variants almost equal neutralization. We have in the meantime also real world data for the activity of our vaccines. For example, against the UK variants that are more than 90%. In the Israel real world data, almost 90%. From real world data from Qatar – and we have also seen last Friday a publication showing you real world data from Qatar showing that our vaccine is able also to prevent infection, PCR confirmed infection with a 75% of effectiveness. We have also seen in our laboratory experiments that increasing the neutralization antibody titer, besides also an increase of neutralizing antibody titer and almost normal neutralization antibody titers against, for example, South African variant. So, at the moment, we don't see any reason to adapt our vaccine, but we are working on establishing a process and the regulatory framework by executing a blueprint prior to ensure that. And potential change to a new variant would only impact as far as we can see at the moment, just the DNA template without changing any other process, the manufacturing process appears to be absolutely robust for all kinds of variants. So, that means once we have a decision for a new variant, we can just change the DNA template, and without losing any production capacity, come up with supply of the new variant vaccine.

And your next question comes from Daina Graybosch from SVB Leerink.

It's a follow up right on the conversation you just had. Given this really impressive real world effectiveness against B.1.351, I think you mentioned Qatar was 75%. I'm wondering how you plan to select between the four different booster strategies that you currently have in the clinic? Do you think that you can get a differentiating predictive signal on immunogenicity data? Or is that decision going to require a larger outcomes trial?

The clinical trial that we are performing is really evaluating different questions. One question is what is the immune response that we get if you use homologous booster. And this will be, of course, analyzed against the wild type strains, but also against mutants. So, that will answer the question that a single booster is improving also the response against the variants. And then we have the question that a booster vaccine with a variant is able to produce variant-specific immune responses. And we will analyze that again, evaluating wild type and variants virus neutralization assays. And then, the last question is whether the variant – vaccination with a variant in naïve subjects induces variant-specific immune responses in the same way as we have seen with the vaccination of the wild type in naive subjects. So, these are different types of questions. Some of the questions are scientific and address also future adaptation strategies. Some are more pragmatic, enabling just a change of our vaccine and providing the regulatory framework.

Just a quick follow-up on that. So, when you have all this immunogenicity data against the wild type variant, what's the regulatory path, just the one that has the best neutralization profile you'll go forward?

No, the regulatory path is really enabling a flexible response. So, the trial is not in the sense of decision making. The trial has two objectives. One objective is really providing the regulatory path to enable based on a non-inferiority analysis that variant vaccine can be established whenever needed. That's the one. And the second is the set of scientific question that I just elaborated.

Your next question comes from Daniel Wendorff from Commerzbank.

I have also a follow-up question on the potential regularity of booster shots to be given looking into 2022, 2023. And you mentioned already a few contracts with customers having been signed here, e.g. Canada, and how do you think the booster vaccination campaign would look like? Would it be largely elderly people then receiving the booster shots again? Would it be more younger people in order to establish a certain level of immunity amongst the younger generation? So, any idea, views you have currently on this topic would be much appreciated. Özlem Türeci: I can take this question. These questions about prioritization and concrete roll out of a potential booster campaign, the success we as a vaccine developers and manufacturers cannot decide. These are policy questions and have to be decided by the respective regulatory authorities or government. With regard to the necessity of booster shots, while we believe that booster shots will be of high value to reestablish full immunity and most likely also expanded against emerging variants, we do not know yet when and how frequently these are needed. The upcoming data from follow-up of immune responses and also the real world data regarding protection will inform us about this.

Your next question comes from Akash Tewari from Wolfe Research.

This is [indiscernible] for Akash. We have one question regarding about WTO's IP waiver. So, can WTO compel BioNTech to share tech transfer information such as undisclosed information or trade secrets outside the published patent? Thank you. Özlem Türeci: Ryan, can you take this question?

As I understood it, the question was, can the WTO compel manufacturers to release information beyond the patent? Is that the question?

Yeah.

I think it's a little bit premature to try to pinpoint precisely what a hypothetical resolution may or may not include. I think our position on the resolution was mentioned earlier by Ugur, and that is that IP is an important part of proprietary asset for BioNTech, it's something that we've spent over a decade of investment that's gone into our IP portfolio. However, we don't believe that it's the bottleneck to accelerating production or supply of our vaccine to the world. And actually, when you look at our global supply network that we already have assembled, it includes actually 15 different production nodes in that network. So, we've already taken great steps to try to expand our supply footprint on both sides of the Atlantic and now with the next steps announced today into Asia. So, that would be my response to the question, but I think it's a little bit early to tell how this will play out.

Your next question comes from our Arlinda Lee from Canaccord.

I was wondering on your comment on becoming a fully integrated global immunotherapy company, what areas of emerging therapeutics like you'd be interested in? You had a paper recently on autoimmune disease. Can you maybe talk about that a little bit?

I believe this is a more general question, which is the direction which we are addressing this – our mRNA development. In the last few years, we have shown that our mRNA vaccine technology platform allow us to develop classical cancer vaccines, personalized cancer vaccines. We have now a program where we use mRNA vaccine to stimulate CAR-T cells. So, that means that's the first steps from the cancer vaccine to the T cell space. Then we have shown that mRNA vaccines can be used also in preclinical setting to evaluate autoimmune disease, and this is is for sure a direction which will address in the next year and clinically [indiscernible]. Moreover, we are using mRNA to deliver therapeutic proteins. As Özlem stated, we have now the first mRNA encoded cytokine molecules in clinical testing. There are more cytokine mRNA encoded cytokines in our pipeline. We have mRNA encoded antibodies, which includes IgG antibodies as well as bispecific antibodies. So that means, our clinical pipeline already today covers a number of pharmaceutical molecules to be delivered by mRNA. And we will certainly expand that. And we will certainly also accelerate the clinical development of some of these molecules towards the market.

Your next question comes from Zhiqiang Shu from Berenberg.

I'd like to ask about the flu vaccine you're going to move forward in the clinical trial with Pfizer. I was wondering what kind of is the mRNA construct? Is that – I recall, in 2017, you published a self-amplifying mRNA version in a preclinical study. And related to that, do you plan to share results in your self-amplifying COVID vaccine? I remember it is also testing a Phase I trial. Özlem Türeci: We have not yet closed which specific vaccine platform and mRNA format will be used in the cooperative development of the flu vaccine together with Pfizer. With regard to other platforms we are working on, for example, the self-amplifying vaccine platform, there will be data sometime next year which we will disclose from our ongoing assessments, also clinical assessments.

We will now take our last question. And this comes from the line of Simon Baker from Redburn.

On the P&L, if I may, please, a two parter. Firstly, for the gross margin, were there any distorting factors in the gross margin this quarter related to previously expensed inventory? Or is that a good run rate for the rest of the year? And also on tax, it doesn't look like you've utilized any tax carryforward losses in the quarter, given the rate was close to the German corporate rate. Do you intend to use those later on in the year? Or is 31% a reasonable indication for the effective tax rate for 2021? Thanks so much.

This is Sierk. There are some phase milestones actually in the numbers. So, this is a little bit of a distortion. But keep in mind that the sales that we're showing is predominantly part – it's like Pfizer's gross contribution after a 50/50 split already. So, what Pfizer and we share as profit comes into our P&L as a sales item. So, that's why there's some – not call it distortion, but you can pro rata go with, like, the volume that we sell into the market. So, this is one effect. But, yes, in this number, there's also phase milestones included, and especially the gross margin from Pfizer. So, this is comment one. And comment two, yes, we're going to lose our tax loss carryforward. They're partially included already in this tax calculation. The tax that we are calculating, we have – like, 24% of the tax loss carryforward is already in this quarter. We are actually updating the calculation with the deferred tax asset that we have from last year, plus also the tax loss carryforward. So, we will see a net rate of 31% roundabout in the end.

We have no further questions at this time. I would now like to hand you back to Sylke Maas for closing remarks.

Thank you again for joining the call today. We look forward to speaking to you in future. Thank you and bye-bye.

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