BioNTech SE Q2 FY2021 Earnings Call

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. I must advise you that 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 to 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 during this conference call and webcast. Also, please note that lines 3 and 4 provide 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 I 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 continues to be strong as we 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. We are truly humbled by the impact our vaccine and our company are having in addressing the global pandemic. We have also had a strong first half-year in terms of the number of new states in oncology as we accelerate the development of our bold pipeline. My team will delve into this in our prepared remarks. Moving to Slide 7. Our strategy remains focused on developing a bold pipeline of next-generation immunotherapies and vaccines and bringing them to key providers to address unmet medical needs in cancer and infectious diseases, alongside growing 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 about what this means: in addition to shipping more than $1 billion doses of our first authorized products, in the second quarter, we expanded our oncology pipeline to a total of 15 clinical-stage programs and 18 ongoing trials. I expect our pipeline to continue to broaden as we expand our research and development and initiate additional clinical trials over the next 12 to 24 months. We are also increasing investment to strengthen our capabilities, including our digital technology spectrum. In the first half of the year, we initiated several new research and development projects aimed at exploring the power of artificial intelligence and machine learning technologies across our organization to discover and optimize new immunotherapies. BioNTech will become a technology company of the coming age, exploring and exploiting innovations in a very disruptive technology field. We believe in a future where our innovations can make a difference for many people around the world with technology that cannot be effectively created today. Finally, to accelerate the accomplishment of these objectives, 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 of launching much of our products in the next five years. Slide 8 shows the key highlights for the second quarter. Starting with COVID-19, we have now distributed vaccine doses to more than 100 countries and regions globally. As of July 25th, we and our partner have signed supply contracts for delivery of approximately $2.2 billion in 2021. Furthermore, we'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 significant commitment that is only possible due to the investments we have made with our partners over the past five months to continue to increase our joint manufacturing capacity, now exceeding $3 billion. In oncology, we have initiated six trials in the first half of 2021. This includes randomized phase II trials for our BNT1116 and checkpoint inhibitor refractory melanoma and for BNT113 in head and neck 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 trial, we initiated the first-in-human trial for a new program from our platform in the first half of the year. This includes our first CAR-T program, our NEOSTIM ex vivo TCEP program, and the first program from our RNA platform, where we include cytokines in vivo using mRNA. All these programs are targeting solid tumors and are wholly owned by BioNTech. We have recently welcomed Jens Holstein as our new CFO, who joined our executive management team on July 3rd. Jens is an accomplished executive who brings significant experience as a financial steward and operator. His expertise will allow us to focus on our strategy moving 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 acquisition 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 a personalized TCR platform that complements our pipeline of individualized cancer therapies that we aim to build a long-term leadership position. Turning to Slide 9. We see infectious diseases as a long-term growth pillar for BioNTech. We believe the technology behind our COVID-19 vaccine has the potential to address a range of other infectious diseases. This potential could play an important role in future pandemic preparedness. We are investing in vaccine programs to address diseases that are particularly prevalent 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 to provide protective immunity for the prevention of malaria, with a clinical plan initiation by the end of 2022. Malaria is a disease that affects more than 200 million people worldwide every year, 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 framework of our malaria project is dedicated to the development of sustainable vaccine production and 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 backed by the collective power of the WHO and the Africa Centers 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 are providing additional support to set up needed infrastructure. As a reminder, we have several 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 initiating 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 with significant unmet medical needs. With multiple programs in preclinical development, we expect to bring candidates to the clinic by next year. Finally, BNT161, the influenza vaccine program, 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 depict the capabilities we are building across our technology platforms, which include a diverse range of potentially first-in-class therapeutic approaches. While our focus historically has been on immuno-oncology, we are investing to expand the application spectrum of our technology toolkit to address an even broader range of immunological targets and mechanisms of action. This means building out our platforms and developing new complementary approaches that harness the power of the immune system. To conclude on Slide 11, we believe that the broad spectrum of our technology will enable us to bring forward new product paradigms that have the potential to broaden the disease horizon beyond oncology and infectious disease to include allergy, autoimmune diseases, inflammatory diseases, and even regenerative medicine. We believe that the new product paradigms we are creating have the potential to expand on traditional therapeutic approaches. This includes mRNA vaccines for other infectious diseases that we believe our technology can enhance efficacy or producibility beyond what has been achievable with other vaccine modalities. We also see the opportunity for new modalities such as mRNA cancer vaccines or immunotherapies based on mRNA-encoded proteins, such as our personalized and novel therapeutic platform. Finally, we believe our toolkit is flexible enough to accommodate new disruptive modalities at the intersection of mRNA and cell therapy such as our CARVac approach, which uses mRNA to enhance T-cell persistence in vivo. We will continue to combine our immuno-oncology expertise and powerful technology to unlock this new therapeutic 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 as shown on Slide 13. Discussions for additional contracts remain ongoing. As of July 21st, along with Pfizer, we 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 December 31, 2021, and the remaining 90 million doses no later than April 20, 2022. We also have a contracted supply for 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 contracted for more than 1 billion doses of our COVID-19 vaccine to date for 2022 and beyond. The U.S. government and European Commission also have the option to acquire an updated version of the vaccine to address potential variants as well as new formulations, if available, as they 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 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, with a not-for-profit price for which 200 million doses are scheduled for 2021 and 300 million doses in the first half of 2022. The U.S. government will then donate these Pfizer BioNTech vaccine doses to low- and middle-income countries and organizations that support them. This will further support multilateral efforts to address the surge of infections 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 site will exclusively be distributed within the 55 member states of the African Union. Moving now to Slide 14. As we've done on previous calls, I will provide an update of our key levers 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 three 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, have already begun technology transfer, on-site development, and equipment installation at the new site. At full operational capacity, Biovac's 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 populations, we are pleased that we have received expanded authorizations for adolescents aged 12 years and older in the U.S., the European Union, and many other countries. As previously detailed, 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 are 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 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 were observed up to 6 months after the second dose. 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 at 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, with data expected in the third quarter of 2021. As we continue to learn about emerging variants, our teams are rapidly responding 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 variants, we have expanded trials to assess both variant-specific versions of BNT162b2 as well as a 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.

Thank you, Sean. To pick up where Sean left off, we believe the duration of vaccine protection and cross-protection against variants are interconnected outcomes. Slide 15 shows follow-up data from our landmark trials that enrolled more than 46,000 participants at over 150 sites around the globe. This data shows vaccine efficacy remained high at 91.2% for up to six months following the second dose of our vaccine. Of the 971 confirmed symptomatic cases of COVID-19 in the trial, 889 cases were in the placebo group and 82 cases were in the BNT162b2 group, demonstrating clinical protection against severe disease at six months after the second dose of 95.7%. In 800 participants in South Africa, where the Delta variant was prevalent at that time, 9 cases of COVID-19 with 8 being the Beta variant were observed, all in the placebo group, demonstrating clinical protection against the Beta strain. What about the Delta variant, which is currently a major concern? There are several data sources to look into shown on Slide 6. One, neutralizing antibodies—we constantly assess sera from vaccine recipients in the trial for their ability to neutralize emerging variants. Sera from participants who received two doses of BNT162b2 demonstrate preserved in vitro neutralizing activity against several variants of concern, including Delta and related variants, as shown in the left panel. While the neutralization titers against Delta appear lower than against our ancestral strain USA-WA/2020, neutralization remains robust. T-cell responses are a second layer of defense. Those elicited by BNT162b2 target multiple epitopes within the spike protein. The sequences of the epitopes recognized by these T-cells are shown and aligned for five SARS-CoV-2 lineages in the figure on the top right, demonstrating that these epitopes are highly conserved across a variety of different variants, including the Delta variant. Additionally, there is real-world data for vaccine effectiveness against emerging variants. A recent study by Public Health England found that full vaccination with BNT162b2 was 88% effective against symptomatic disease from the Delta variant and provided 96% vaccine effectiveness against hospitalization caused by the Delta variant. A study from Canada found that full vaccination with BNT162b2 resulted in vaccine effectiveness of 87% against symptomatic infection from Delta and 100% protection against hospitalization. A nationwide survey and study involving 5.4 million people from Scotland estimated that BNT162b2 was 79% effective against Delta. In July, the Israel Health Ministry reported that BNT162b2 mediated effectiveness in preventing both infection and symptomatic disease had fallen to 39% from 64.4% earlier in July, while effectiveness against severe COVID-19 disease, including prevention of hospitalization, continued to be as high as 91.4%. Waning vaccine effectiveness observed in Israel coincides with the spread of Delta and the end of social distancing restrictions in the country. We believe that another important factor is the early start date of the first vaccination programs relative to the rest of the world, and that many high-risk populations had received their second dose more than six months prior to July, a time which increases the risk of infection in these individuals. The point I want to make is that, broadly speaking, as of now, evidence points to robust vaccine effectiveness against circulating variants in the real-world setting, including a high vaccine effectiveness against severe disease. Factors such as public health measures and restrictions that are in place will also impact how this plays out in the real world. Continued monitoring of real-world data and immunogenicity data is warranted to understand when a booster or a variant-specific vaccine will be required, which of course is at the discretion of global health authorities. To be prepared for the scenario that our response to variants of concern may become necessary soon, we are establishing a development and regulatory pathway for a variant-specific prototype approach, as shown on Slide 17. This approach also aims to address the question of whether boosting with the original BNT162b2 may suffice or if variant adaptation may be required. Our prototype approach includes four workstreams. The first evaluates the first dose of BNT162b2 in fully vaccinated participants. 300 participants were assessed for safety and immunogenicity, and I'm going to show data on the next slide. Another 10,000 participants will be reassessed for the efficacy of the first dose of BNT162b2, with data expected in Q4 this year. The first ongoing trial evaluates safety and immunogenicity of a Beta variant-specific vaccine in 340 BNT162b2 vaccinated participants, as well as two doses of the Beta-specific version in 300 vaccine-naive participants. Data from this trial is expected in Q3 2021. We are also planning to initiate a trial that will evaluate a Delta variant-specific version, an Alpha variant-specific version, and also a multivalent vaccine, including both versions of BNT162b2. This trial will include around 600 vaccinated participants and 300 new participants. Data from this trial is expected in Q4. We expect the data from these trials to significantly enhance our knowledge about vaccine protection and variants of concern and also help to inform the optimal path moving forward. Preliminary data from our comprehensive endeavor are already available. Recently published data from this first workstream show that administration of a third BNT162b2 dose 7 to 9 months after the second dose elicits a robust neutralization response beyond what was originally observed after the second dose. The graph on the top right shows that in elderly adults, neutralization has almost fallen to the level of detection by 7 to 9 months. Boosting with a third dose induces a robust neutralization response against the original ancestral strain and the Beta variant. Neutralization titers against the Delta variant are over fivefold compared to those observed after the second dose in the age group of 18 to 55 years and even over elevenfold in the older age group of 65 to 85 years, as shown in the graph on the bottom right. Furthermore, the difference in neutralizing titers against the ancestral virus and the Beta variant narrowed after the third dose compared to after the second dose, implying that in addition to prolonging protection, a booster dose may increase the breadth of the neutralizing response against SARS-CoV-2 variants. The third dose is safe and well tolerated according to our data. These data are being prepared for submission to global regulatory authorities to support the potential introduction of a booster dose in the product information. We continue to believe that it is likely that a fourth booster dose may be needed within 6 to 12 months after full vaccination to maintain the highest level of protection. Therefore, we are in ongoing discussions with regulatory agencies regarding potential booster recommendations for those who received our current vaccine. Transitioning to our oncology pipeline on slide 20, Ugur has already outlined our immuno-oncology strategy, which is based on several first-in-class immunotherapy approaches to modulate the immune response against cancer. Each of our therapeutic platforms has at least one product candidate in the clinic, and several of our product candidates have the potential to be combined synergistically with other pipeline programs. Slide 21 provides updates on select oncology programs. We now have 15 product candidates in 18 clinical trials, including three Phase 2 trials. In our FixVac platform, we have started two Phase 2 trials in the last two months. I will discuss those programs in more detail shortly. We also anticipate dosing the first patient in our iNeST Phase 2 trial in the Axovant colorectal cancer setting in the second half of 2021. We expect data readouts across both of the next-generation immune modulators, BNT311 and BNT312 that we develop with our colleagues from Genmab. There will also be a data update for our Claudin 6 CAR-T therapy BNT211 in the second half of the year. Enrollment into higher dose levels is ongoing in that trial. We have also treated the first patients with Claudin CAR-T cells in which the COVID vaccine to selectively stimulate this doctor-prescribed engineered activation has been conducted. 2021 is our second therapy program in solid tumors that started first-in-human clinical testing this year as well. Moving on to Slide 22, I would like to discuss our wholly-owned FixVac platform, which has five product candidates for multiple indications currently in clinical trials. Each FixVac product candidate targets a set of shared tumor-associated antigens that are commonly expressed by a significant portion of patients in a given cancer type. RNA technology design elements used for FixVac include an RNA backbone optimized for high protein yield, augmentation of innate and immune response induction, and LPX formulation for systemic administration. Our RNA-Lipoplex approach has been optimized for widespread delivery of tumor antigens, targeting resident dendritic cells to induce strong T cell responses. As shown on the bottom of this slide, we have observed strong vaccine-induced CD8 T-cell responses across different cancer types against non-mutated shared tumor-associated antigens for melanoma in the BNT111 Phase 1 trial and for HPV16-positive head and neck cancer in the BNT113 Phase 1 trial. Our clinical trials and preclinical studies have demonstrated that these dual vaccines activate and expand a complement of CD4 and CD8 T-cells and also that these newly generated T-cells benefit from PD-1 blockade. This suggests that vaccines based on non-mutant tumor-associated antigens may have potential clinical utility in combination with anti-PD-1 for tumor control in patients with no mutational burden, including those who have already experienced checkpoint inhibitor therapy. Two such programs just moved into Phase 2 trials: BNT111 in checkpoint inhibitor-refractory melanoma, and BNT113 in HPV16-positive head and neck cancer. In addition, we have an ongoing Phase 1 trial for our BNT112 program in metastatic castration-resistant prostate cancer. On Slide 23, there has been nearly a 50% increase in melanoma prevalence over the last decade, and it is predicted that by 2025, the number of melanoma deaths will increase by a further 20%. The latest therapeutic advancements we've seen in the standard of care are immune checkpoint inhibitors, particularly PD-1 blockers. While checkpoint inhibitors elicit responses in only a small fraction of patients, in the majority, the duration of responses is short, and over half of the patients are refractory to relapses on immune checkpoints. Those who are refractory to these compounds typically have poor prognoses, with survival shorter than six months, depending on the risk factors. Our FixVac candidate BNT111, introduced on Slide 24, encodes a fixed set of four shared antigens covering more than 90% of cutaneous melanoma patients. In 2020, we published promising preliminary data from our Phase 1/2 trial in Nature. BNT111, both as a monotherapy and in combination with anti-PD-1, shows a tolerable safety profile and durable objective responses in checkpoint inhibitor-experienced melanoma patients with evaluable disease. We believe that these positive data provide compelling support for BNT111 in combination with anti-PD-1. In June 2021, our BNT111 program moved into a Phase 2 trial in patients with anti-PD-1 refractory or relapsed, unresectable stage 3 or stage 4 melanoma. This global trial, which we are conducting in collaboration with Regeneron, is outlined on Slide 25. It will enroll 120 patients randomized to 2:2:1 in three treatment arms to evaluate BNT111 in combination with Regeneron's cemiplimab and each track as immunotherapy. The primary endpoint is the overall response rate in the BNT111 plus cemiplimab arm, where we consider the study to be successful if data show an overall response rate of 30% and a duration of response of more than 15 months. On Slide 26, we present our FixVac product candidate, BNT113, for the treatment of HPV16-positive head and neck cancer. Oropharyngeal cancer is the most common head and neck cancer type, accounting for a significant proportion of head and neck cancers, and up to 90% of those are HPV16-positive. In contrast to other types of head and neck cancer, HPV16-positive cancers typically occur in younger patients and are not associated with traditional risk factors like tobacco or alcohol. Most patients are diagnosed at advanced clinical stages and are often treated with chemotherapy, surgery, and radiation. Immune checkpoint inhibitors, such as pembrolizumab and nivolumab, are approved for recurrent or metastatic head and neck cancer treatment, with pembrolizumab also approved as first-line therapy for patients with unresectable or metastatic disease. The historical overall response rates for pembrolizumab and nivolumab in recurrent metastatic head and neck cancer range from 13.3% to 17%. For patients who fail or progress on checkpoint inhibitors, limited treatment opportunities remain. We see a significant opportunity to improve the treatment landscape with BNT113, which could augment clinical responses in patients treated with checkpoint blockers. Moving to Slide 27, BNT113 targets the well-characterized HPV16-derived oncoproteins in E6 and E7. These proteins are highly immunogenic viral neoantigens found exclusively in malignant cells. Viral oncogenes are acknowledged as safe and promising targets, while immunotherapies have proven to be highly immunogenic and are not subject to immune escape. Given the high number of patients with HPV16-positive head and neck cancer who are also PD-1 positive, we believe there is potential for a synergistic anti-tumor effect when BNT113 is combined with checkpoint blockade. Slide 28 shows early clinical data in HPV16-positive head and neck cancer from our ongoing Phase I/II trial, demonstrating strong vaccine antigen-specific CD8 and/or CD4 T-cell responses in the majority of patients. As shown in preclinical experiments, these newly primed T-cells benefit from immune checkpoint blockade. We have commenced our BNT113 clinical trial as shown on Slide 29 and recently dosed the first patients in the safety portion followed by a subsequent randomized portion, treating patients with unresectable recurrent or metastatic head and neck cancers positive for HPV16 and expressing PD-1 with a combination of BNT113 and the checkpoint inhibitor pembrolizumab, while pembrolizumab monotherapy represents standard treatment. The overall objective for this trial was a targeted median overall survival of 18 months and an overall response rate of 40% in the combination treatment. We are also co-developing a PCR-based companion diagnostic to select patients for treatment with BNT114, which will be clinically validated as part of this trial. Moving to Slide 30 now, I would like to provide a short update on our iNeST program, BNT122, which is partnered with Genentech. BNT122 is designed to target patient-specific neoantigens and is a fully individualized cancer vaccine currently undergoing two trials in metastatic cancer. We are now moving into the adjuvant treatment space, with the Phase 2 trial in colorectal cancer being the first indication. The study will compare the efficacy of BNT122 versus watchful waiting in resected stage 2 high-risk and stage 3 colorectal cancer patients who are ctDNA positive following 3 to 6 months of adjuvant chemotherapy as standard of care. In a first screening round, the circulating tumor DNA or ctDNA status of the patients will be determined for eligibility, which is the main risk factor for disease recurrence. In a second screening of eligible patients, Neoantigen selection based on the patient's individual tumor will be performed, and BNT122 manufacturing will commence. This process takes about 3 to 6 weeks while patients undergo 3 to 6 months of adjuvant standard care therapy. Final eligibility for the study will be reassessed before randomization, with eligible patients then assigned in a one-to-one ratio into two treatment arms: one receiving BNT122 and the other under observation. Patients in the experimental arm will receive six weekly vaccinations followed by two-weekly vaccinations, with further vaccinations every six weeks for up to 12 months. The trial also includes a biomarker cohort for patients irrespective of ctDNA status. A second exploratory cohort will involve patients who have recurrent disease at the first screening. Patients in both of these cohorts will be dosed with BNT122, and we anticipate dosing the first patient later this year. Coming up next on Slide 31 is the RiboCytokine template form, which exemplifies the diversity of our RNA technology, which, depending on the design elements we choose, can be used for various purposes. In this case, we used our RNA technology to encode T-cell homeostatic cytokines that would otherwise be administered as recombinant proteins. Cytokines encoded by mRNA and produced in patients have the potential for improved safety and therapeutic efficacy and more favorable cost of goods compared to their recombinant protein-based counterparts. Recombinant protein-based IL-2, for example, has been shown to induce durable responses in some tumor types but presents significant drawbacks, such as a short half-life, requiring frequent and high dosing associated with toxicities such as infusion reactions and liver toxicity. Our RiboCytokines are designed for improved pharmacokinetic properties with a prolonged serum half-life and high bioavailability. This configuration allows for lower and less frequent dosing, which may result in better tolerability. A RiboCytokine encoding a cytokine fused to human albumin has an RNA backbone optimized for high protein production, and it is nucleoside-modified making it non-immunogenic. The RNA is encapsulated in liver-targeting LNP enabling intravenous systemic delivery. Shown on Slide 32, we currently have two RiboCytokine product candidates in clinical trials that feature IL-2, a key cytokine in T-cell immunity supporting differentiation, proliferation, survival, and effector functions of T-cells. In addition to activating effector T-cells, IL-2, as a physiological counter-regulatory mechanism, also activates suppressive regulatory T-cells through one of its three cellular receptors, namely the IL-2 receptor alpha subunit, also referred to as CD25. BNT151 is a sequence-modified IL-2 engineered to reduce binding to this subunit while maintaining binding to the other IL-2 receptor components. This modification selectively activates effector anti-tumor T-cells, favoring those effectors with low or no expression of CD25. Thus, we anticipate that BNT151 will be an optimal combination partner for anti-PD1 or anti-PD-L1 therapy. A Phase I trial for BNT151 is currently ongoing. Our BNT152-153 product candidate consists of two components. BNT153 encodes a natural IL-2 and maintains high-affinity binding to CD25-positive T-cells, accordingly stimulating 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 controlling the fraction of immunosuppressive regulatory T-cells. We believe BNT152 plus BNT153 could present a potent combination suitable for a partner with cancer vaccines, as vaccines generate T-cells that express high levels of CD25. We dosed the first patient in June 2021 with this combination in a first human Phase I trial in patients with solid tumors. We plan to combine this combination of T-cell-formulating cytokines with other products in our pipeline, such as our FixVac platform. Now to wrap up my part for today, Slide 33 highlights a number of key milestones achieved so far this year, as well as significant milestones we expect in the back half of 2021. In addition to our clinical updates from COVID-19 vaccine programs, we anticipate further data updates 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 also launched four first-in-human clinical trials of therapeutic programs, expecting three more this year. We have made significant progress in accelerating our pipeline in the first half of this year, and I look forward to updating you on upcoming milestones in the near future. I now turn the call over to our Chief Financial Officer, Jens Holstein, who will discuss our financial results.

Thank you, Ozlem, and good welcome to those of you on the phone. I've been in my role for 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, and I look forward to supporting my colleagues in our mission to make a significant impact on human health. Let me 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 estimated revenues of approximately EUR 5.3 billion for the second quarter of 2021, compared to EUR 41.7 million for the comparative period in 2020. For the period ending June 30, 2021, we report an estimated total revenue of around EUR 7.4 billion compared to EUR 69.4 million for the prior-year period. Total revenues increased due to the rapid increase in supply and sales of our COVID-19 vaccine worldwide. As a reminder, for 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 EUR 4.1 billion and EUR 5.8 billion for the first two 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 figures mentioned amounted to EUR 168.6 million for the second quarter and EUR 415.8 million for the period of six months ended June 30, 2021. Similar to previous quarters, the figures for our profit share are estimated based on preliminary data shared between Pfizer and us. These 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 profits will be recognized prospectively. Our COVID-19 vaccine commercial revenues in the second quarter also include EUR 138.1 million in sales to our collaboration partners of products manufactured for us, as well as around EUR 1 billion of direct COVID-19 vaccine sales to customers in our territories, including Germany and Turkey. For the period ended June 30, 2021, we had sales to our collaboration partners of EUR 202 million and approximately EUR 1.2 billion in direct COVID-19 sales in Germany and Turkey. Returning to Slide 35 and moving to cost of sales, which were estimated at EUR 883.8 million for the second quarter of 2021, compared to EUR 5.6 million for the comparative period in 2020. For the six months ending June 30, 2021, total costs of sales were estimated to be around EUR 1.1 billion, compared to EUR 11.5 million for the prior-year period. The increase was driven by an estimated amount of EUR 872.1 million for the second quarter of 2021, around EUR 1.1 billion for the period of six months ended June 30, 2021, which was recognized as cost of sales regarding 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 EUR 201.1 million for the second quarter of 2021 compared to EUR 95.2 million for the comparative period in 2020. For the six months ended June 30, 2021, research and development expenses reached EUR 417.3 million compared to EUR 150.3 million for the previous year's comparative period. The increase was primarily due to heightened research and development expenses related to our BNT162 program recorded as purchase services concerning those expenses which were initially incurred by Pfizer and subsequently charged to us under our collaboration agreement. Notably, development costs were shared equally between the two companies. The increase was further driven by rising wages, benefits, and social security expenses due to increases in headcount, as well as recognizing inventor compensation expenses and expenses incurred under new share-based payment arrangements. General and administrative expenses were EUR 47.8 million for the second quarter of 2021 compared to EUR 18.8 million for the comparative period in 2020. For the six months ended June 30, 2021, general and administrative expenses were EUR 86.7 million compared to EUR 34.6 million for the prior-year period. The increase was primarily due to heightened wages, benefits, and social security expenses from increasing headcount, as well as expenses incurred under the new share-based payment arrangements and higher expenses for purchased management, consulting, and legal fees, alongside higher insurance premiums. Interim income taxes were approximately EUR 1.2 billion for the second quarter of 2021 and around EUR 1.7 billion for the six months ended June 30, 2021, recognized using the estimated annual effective income tax rate of approximately 31%. For the second quarter of 2021, net profit reached approximately EUR 2.8 billion compared to a net loss of EUR 88.3 million for the comparative period in 2020. For the six months ended June 30, 2021, total net profit was approximately EUR 3.9 billion compared to a total net loss of EUR 141.7 million for the prior-year period. As of June 30, 2021, cash and cash equivalents totaled EUR 914.1 million. Please note that the contractual settlement of the gross profit share under our COVID-19 collaboration with Pfizer creates a temporal offset of more than one calendar quarter. As Pfizer's fiscal quarter for subsidiaries outside the U.S. differs from ours, this creates an additional time lag between recognition of revenues and payment receipt. Consequently, trade receivables that were outstanding as of June 30, 2021 were received as payments only in July 2021, improving our cash position relative to the amount as of June 30, 2021. Moving to Slide 37, we have updated our 2021 financial outlook as we expand and accelerate the development of our broad pipeline. Based on the current contracted supply orders of approximately 2.2 billion doses, we're providing estimated COVID-19 vaccine revenues to BioNTech in 2021 of approximately EUR 15.9 billion. This estimate reflects expected revenues from direct COVID-19 vaccine sales to customers in our territories, expected revenues from sales to our collaboration partners, expected sales milestone payments from our collaboration partners, and expected revenues related to our gross profit share from COVID-19 vaccine sales in a collaboration towards the respective territories. 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 already in place for 2022 and beyond. Please keep in mind that we will deliver a substantial amount of doses to middle- and low-income countries with prices aligned with income levels or on a not-for-profit basis to serve the most vulnerable populations. In terms of guidance for the full year 2021, we anticipate incurring R&D expenses in the range of EUR 950 million to EUR 1.05 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 range from EUR 250 million to EUR 300 million. Capital expenditures for the year 2021 are expected to fall within the range of EUR 175 million to EUR 225 million. These figures are again estimated at constant foreign exchange rates and reflect our current base case projections. Lastly, please note that regarding the full-year 2021 tax impact, we still expect the BioNTech Group’s estimated annual effective income tax rate to be approximately 31%. 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 specialized infrastructure to support our growing cell therapy pipeline, which spans CAR T-cell therapy, Neoantigen ex-vivo T-cell therapy, and personalized TCR-T therapy. Turning to Slide 40, the Gaithersburg facility we've acquired will provide a turnkey 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 bolster the development of our expanding pipeline of novel cell therapies, including cancer product candidates based on our CARVac program and NEOSTIM platform, as well as the newly acquired individualized Neoantigen TCR program from Kite. Furthermore, as a result of the acquisition, BioNTech will gain a team of more than 50 professionals with deep expertise in cell and gene therapy, including a cell therapy production team and a personalized Neoantigen TCR research team. This acquisition reinforces 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, BNT221 NEOSTIM, and our personalized TCR program. Each of these modalities exploits distinct mechanisms of action and is uniquely suited to specific tumor types, broadening the types of solid tumors we can target. Digitalized mRNA cancer vaccines utilize 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 for early adjuvant stage cancers. NEOSTIM, our individualized neoantigen-T cell therapy, utilizes 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 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 positions 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, including four data readouts in our oncology programs and the start of our fourth randomized Phase II trial. Additionally, we're on track to initiate two 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 are well-positioned for success as we execute our strategy to achieve our vision of harnessing the immune system's full potential to fight human disease, and our strong financial position enables us to invest more than ever in our firm and our innovative 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. With that, we'll conclude our presentation and open up for questions.

Thank you. 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 and good afternoon, everyone. Thank you for your question. I wanted to inquire about your booster strategy regarding the new Delta trial and the ongoing tests for the Beta-specific vaccine. It's not surprising to see the emergence of additional variants. Do you expect that the original vaccine will ultimately be the best option for boosting, especially considering the emerging data? Or do you anticipate a shift towards a multivalent product in the future? Additionally, what are your thoughts on comments from organizations like the CDC regarding boosters and whether it will require a surge in breakthrough infections to promote the idea of broader booster use? 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 received a dose had increased neutralization antibody titers, not only against the original variant but 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 using the existing wild-type strain, which creates antibody responses about fivefold higher than the neutralizing antibody titers after the second shot. It is quite possible that, over the next six to twelve months, further variants emerge that would require adaptation of the vaccine. But at the moment, it is 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 related to the strategy around the booster. How much of the view that a third dose of the original vaccine is effective 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 increases 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 question. As Ugur pointed out, the current strategy, based on available data, is to continue with the ancestral strain for the current variant, or with the original vaccine, rather than adapting. It's better to boost with that strain. A significant portion of the supporting data comes from neutralizing antibody specimens that I've presented. Still, we have other data from other groups that show that the vaccine generates neutralizing antibody titers that are cross-reactive: after the second dose and cross-neutralizing towards other strains, including the Delta variant. Specifically, our third dose data shows a significantly boosted neutralizing antibody response. We believe it is a robust strategy to continue boosting with the ancestral strain. Our plans going forward include producing additional data to better understand what adapting the strain could bring in terms of added value and added safety margin. This involves our ongoing clinical trials where we vaccinate naive subjects, as well as those who have received the first two doses with the ancestral strain. They will also be vaccinated with the South Africa variant and the Delta and other variants as individual vaccines or in combinations. These studies will inform us about the immune responses and help clarify the efficacy, whether strain adaptation is necessary and beneficial. So this approach is indeed something we are going to investigate as we go forward.

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 a 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? In that scenario, if we achieve full approval for the initial doses, how would it work practically 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. What we expect is that, based on the data generated, including safety data, recommendations for booster doses will vary by region. Already, recommendations exist—for instance, Israel recommends booster doses, and Germany supports booster doses for the elderly. This process will happen under the emergency use framework. On one side, it includes the primary vaccination of those who have yet to receive the vaccine to immediately control infections, while concurrently enabling booster vaccination for those who received the prime-boost vaccination five or six months ago, ensuring an increase of antibody titers. Hence, these actions will occur in parallel. Country-wise or region-wise recommendations may support different policies.

So are you implying that an EUA has the potential to be designated for booster populations, particularly with the FDA?

Yes. Indeed, what is needed, region by region, different projects for the dynamics concerning approvals, which will likely come at various times, per region. The approval process is the first critical step, followed by recommendations from vaccine committees or policies that arise from government decisions. Hence, we will likely see a mixed solution of policies region by region.

If I may add here, this is a pandemic that has resulted in an unusual situation concerning regulatory pathways. We are collaborating closely with health authorities on how to implement the third doses under EUA submissions, ensuring this aligns with respective pandemic strategies in each region. We need to work this out collaboratively with the relevant health authorities.

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

Hi. Good afternoon, everyone. Thanks for the question. I wonder if you could elaborate on your business development approach and what you're looking to do in the near-term and long-term in terms of capabilities, capacity, targets, or modalities. Also, do you believe that you need your own PD-1 to support your rich portfolio of IO programs?

Hi Daina. Regarding your inquiry about our business strategy or development strategy, we are currently focused on accelerating and broadening our internal pipeline. Additionally, we are interested in complementing our pipeline with additional IO molecules. PD-1 molecules are among the options we are considering if they meet our criteria. We have our own IO molecules currently in development, such as our PD-L1+ program, which is a bi-specific molecule, and we are also developing additional IO candidates. Over the next 12 to 18 months, we plan to engage in deals to increase our pipeline and secure combination partners for our vaccines and immune modulators that we currently have in play.

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 about the booster opportunity here. Given the waning protection of the vaccine, I think a critical question is about the T-cell response. Can you talk about based on our current understanding, what the role of T-cell response, particularly memory T-cells, will be in 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 relates to the selection of the Neoantigen? Thanks very much.

Let me start with the first question regarding the role of T-cells. We have two layers of immunity against this virus. The first layer is the neutralizing antibody response, which inhibits the uptake of the virus; and the second layer comprises CD8 T-cells, which can recognize and destroy infected cells, as well as CD4 T-cells that help enhance antibody and T-cell responses to restore antibody responses. Animal studies have shown that T-cells can provide protection against severe disease, and several publications indicate that this also holds for SARS-CoV-2. This means having T-cells present can help inhibit severe disease progression. We're observing this phenomenon in the clinical studies. Although antibody titers are decreasing, most infections are mild, and severe disease remains protected due to the T-cell response lasting longer. We anticipate that we will see breakthrough infections, but most individuals will be protected from severe disease, thanks to the more persistent T-cell response. Does this address your first question? Can you please repeat your second question?

Yes. I would like to know more about the read-across across different tumor types regarding your FixVac. Obviously, you have quite encouraging data in melanoma, and how should we think about other indications?

Yes, we have two approaches for inducing antigen-specific immune responses in cancer patients. The FixVac is a combination of antigens specifically tailored for a certain cancer type. We have FixVac melanoma, and we have additional products in development, including FixVac for lung cancer and non-small cell cancer, and others for HPV-positive head and neck cancer, etc. Each of these are collections of antigens for their respective types of cancer. The second approach is the iNeST approach, which has a more universal application. We identify personal neoantigens tailored for individuals. Since this approach is universal in nature, it can be applied to a variety of cancer types. We currently have an iNeST clinical trial ongoing, with a basket study examining multiple indications—this has recently began for colorectal cancer.

Thank you. The next question comes from the line of Arlinda Lee of Canaccord. Please ask your question.

Hi, guys. Thanks for taking my question. I was curious about the booster and your broader strategy regarding COVID-19. I know it's fluid, but can the multivalent vaccine include other SARS-CoV-2 proteins? I also saw that you are looking to add for additional variants. How easy is it for your manufacturing setup to change to manufacture these variants? Thank you.

Starting with the last part of your question, we have the capability to swiftly switch strains in manufacturing. The only step we need to do is to use a different DNA template for a new variant. Therefore, we can maintain our entire manufacturing workflow unchanged and continue to produce the vaccine adapted to that variant. This process is technically feasible and, as we demonstrated in clinical trials, we are planning to do this for the Beta variant. We will start with a clinical trial for the Delta variant soon as well. The key question is, and it's not unique to BioNTech, but more broadly applicable: When is the best time to change a strain? For example, we have clear protocols for seasonal vaccine strains. For SARS-CoV-2, the situation is more complicated due to the diverse variants that emerge across continents. The Delta variant is currently dominant; however, there could be other variants that appear dominant in certain regions. Therefore, we're concerned about timing when aligning vaccine updates with specific variant changes. We have fine-tuned our understanding that the booster vaccine containing the parental strain is, for now, sufficient for maintaining immunity. We wait for emerging data before determining whether to adapt to the new variants.

Thank you.

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

Thank you very much for taking my question. Continuing on the issue of boosters, could you provide an idea of the lead time from identification of the desirable variant for a new vaccine to how quickly you could shift to volume manufacturing? As a follow-up, could you provide guidance on how representative this quarter's gross margin is for the rest of the year?

We have communicated that we can effect a change in less than six weeks. This timeframe may decrease as we improve methodologies and efficiency. Perhaps Ryan or Sean could answer your next question regarding gross margins.

Yes, happy to take that question, Simon. Revenue development, as well as gross margin development, highly depends on the mixture. This means that if revenues arise from our collaborations with Pfizer or milestones or direct sales to our collaborating partners, that obviously will influence the gross margin significantly. Additionally, remember that, going forward, there will be a substantial number of dose deliveries to middle- and low-income countries for which we anticipate lower prices or non-profit rates. This will also have an impact on gross margins. Therefore, towards the year-end, I would expect to see a slight decrease in gross margin that you observed 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.