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spk05: Thank you all for joining us today as we review our third quarter operational highlights and provide you with a financial update. BioNTech is an exciting phase of its corporate development and we are delighted to share our brokerage with you. A few housekeeping items before we start. I invite you to view the slides that accompany the webcast and the third quarter 2022 press release, both of which were issued this morning and can be found in the investor section of our website. Taking a first look at slide two, I would like to remind you that during today's presentation, we will make several forward-looking statements. These forward-looking statements include but are not limited to our COVID-19 vaccine revenues, as these include figures that are derived from preliminary estimates provided by our partners, our estimated financial results for 2022, the continued global demand for COVID-19 vaccine, expected COVID-19 vaccine production, supply and delivery for 2022 and beyond, the planned next steps in our pipeline programs, the timing for enrollment, initiation, completion, reporting of data from our clinical trials, the timing of and our ability to obtain and maintain regulatory approval for our product candidates, and other risks described in our findings made with the U.S. Securities and Exchange Commission, including our most recent quarterly report today. 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 the conference call and webcast. Also, please note that slides three and four provide detailed and important safety information regarding our COVID-19 vaccine. Finally, today's agenda can be found on slide five. It is my pleasure to welcome the BioNTech management team, who will guide you through our third quarter update. I'm joined by Uwe Schahin, CEO and co-founder of BioNTech, Erzlem Tureci, our chief medical officer and co-founder, Jens Holstein, our chief financial officer, and Brian Richardson, our chief strategy officer. With that, I would like to turn the call over to Uwe.
spk12: Thank you, Silke. A warm welcome to all participants of today's conference call. I am pleased to update you on BioNTech's operational progress during the third quarter of 2022. Before I start, let me tell you the fundamentals of our success. With our deep expertise in immuno-oncology, our scientific rigor, our fully integrated spectrum of translation research and manufacturing competencies, we succeeded together with our partner Pfizer in developing and supplying variant-adapted vaccines globally. We did so at an unprecedented speed. Since BioNTech inception, we have pursued our vision to establish a fully integrated global immunotherapy powerhouse aspiring to translate science into survival. We follow a technology-agnostic, solution-focused, multi-platform strategy. Our innovation engine leverages various emerging technologies and therapeutic approaches. Our aim is to address high unmet medical needs in oncology, infectious diseases, and beyond. We are advancing a diversified product pipeline of immunotherapies and are saving an unprecedented opportunity to accelerate our progress towards our long-term vision to bring the next generation of immunotherapies to patients. Moving to our third quarter highlights, we reported total revenues of 3.5 billion euros, contributing to total revenues of 13 billion euros for the first nine months of the year. The strong performance can be attributed to the continued successful execution in our COVID-19 vaccine franchise and reflects shipments of the Omicron adapted vaccine booster, which started early in September. We are updating our 2022 financial guidance by raising our vaccine revenues estimated to 16 to 17 billion euros. We have expanded our team to more than 4,000 employees around the world. We are expanding our global mRNA manufacturing network to ensure access to our innovative medicines worldwide. We recently signed a letter of intent with Australia's State of Victoria for strategic partnerships to establish an mRNA research and innovation center and help to translate encouraging academic research into the clinic. We will establish one of our modular BioNTena manufacturing facilities in Melbourne to enable end-to-end clinical scale manufacturing of mRNA product candidates. In oncology, we are executing across our broad pipeline. We have advanced a total of 19 candidates in 24 ongoing clinical trials, including five Phase II trials. In the third quarter, three new programs entered Phase I. At this year ESMO conference in September, we presented another positive clinical update for BNT211 for the treatment of solid tumors. Ersan will share more detail on the data update momentarily. Slide seven highlights our quarter three progress with our COVID-19 franchise. This quarter, we and our partner Pfizer continue to build on our global COVID-19 vaccine leadership with first-to-market Omicron BA.4, BA.5-adapted vaccine launches across multiple countries and regions worldwide. As of mid-October 2022, we have invoiced approximately 300 million doses of our BA.1 or BA.4.5-adapted bivalent vaccines. We had multiple regulatory developments around our original Cominati vaccine. The vaccine is undergoing conversion to full market approval in several regions around the globe. It has received full marketing authorization in the EU for all existing and upcoming indications and formulation. Additionally, we received EC approval for free dose primary series in children aged six months to five years in the EU and for a third booster dose for children aged 5 to 11 years. A fourth booster dose was recently approved by the EC for individuals aged 12 and older. With these regulatory approvals, our COVID-19 vaccine has one of the broadest labels among available vaccines. Our Omicron BA.4.5 bivalent vaccine boosters now have approvals for use in more than 45 countries and regions worldwide. We recently reported initial positive data at the 30-day post-boost time point in the phase 2 free clinical trial of our Omicron BA.4.5 adapted bivalent vaccine in individuals 12 years and older. Additionally, we initiated a phase 1.2 free trial of the Omicron BA.4.5 adapted bivalent vaccine in children aged 6 months to 11 years. At the end of October, as part of our ongoing collaboration, we and our partner Pfizer initiated a phase one clinical trial evaluating our Omicron BA.4.5 adapted bivalent vaccine in combination with an mRNA influenza vaccine. The mRNA influenza vaccine candidate is also partnered with Pfizer and has now advanced to phase three clinical testing after positive data from the phase two trial were reported in second quarter of this year. Slide 8 highlights our COVID-19 vaccine execution on a global scale. Our mRNA platform and established processes allow for development, testing, and manufacturing of variant-adapted vaccines at unprecedented speed, supporting a rapid regulatory path. With the occurrence of Omicron end of 2021, we and Pfizer started evaluating monovalent and bivalent vaccines directed against Omicron sub-lineages and other strains of SARS-CoV-2. Data from this study were presented to regulatory agencies in June and July 2022, which supported regulators' definition of the most appropriate regulatory pathway. It took us approximately two months to go from the first regulatory recommendation for B.4.5 adapted vaccine to our first shipment of the respective vaccine. The ability to execute with such a speed was enabled by three factors. Our continued surveillance and analysis of variants of concern, our extensive and proactive COVID-19 clinical program, and the rapid manufacturing adaptation. We are well positioned to supply countries and regions around the globe. I thank our team and collaborators for their tireless efforts to make this accomplishment possible again. in such a short period of time. Slide nine. The need for an Omicron BA.4.5 adapted booster supported by current research, including our own data, as shown on slide nine. In the northern hemisphere, we tend to see case numbers steadily rising. Epidemiologically speaking, BA.4.5 and their related sub-images continue to be the dominant strains. Omicron BA.4.5 adapted bivalent vaccines may also confer robust protection against potential future emerging omicron sublineages or new variants of concern that are closer to the wild-type strain. The enhanced neutralization breath may be driven by expansion of memory B-cells against epitope-shared pro-EMM variants, as well as, in part, induction of de novo immune responses against new epitopes. Moreover, expansion and preservation of T cell responses may protect against severe disease. Slide 10, looking at the evolution of COVID-19 pandemic and current real world evidence, we anticipate a long-term need for annual or seasonal variant adapted boosters. If the virus is in a state of continuous evolution, the possibility of a new wave of infections driven by novel immune evasive strains remains. We are vigilantly monitoring the landscape and are prepared to adapt our vaccines as needed. The risk of severe COVID-19 disease remains high in the vulnerable population. The full extent of the prevalence of COVID-19 patients who go on to experience longer-term health consequences is also not yet fully understood. Clinical data have demonstrated that boosters extend the protection offered by COVID-19 vaccines, which research has shown natural immunity acquired by SARS-CoV-2 infection is valuable across individuals and the protection it offers reigns over time. A booster restores and enhances infection-acquired immune protection and further reduces the risk of the infection. Slide 11 shows our framework to support a sustainable vaccine business in future. First, we have demonstrated the safety, tolerability, and efficacy of our mRNA COVID-19 vaccines. Second, we have shown our ability to rapidly adapt our product and processes to address emerging variants of concern. Third, our expertise at navigating the evolving regulatory landscape on a global scale has positioned us as a first mover and enabled us to receive one of the boldest labels among currently available COVID-19 vaccines. This applies to both the original Cominati vaccine and our Omicron BA.4.5 adapted vaccine. Fourth, with continued innovation, we are improving the already strong product profile of our COVID-19 vaccine. targeting continued protection from current and future viral threats. These four pillars are built on our validated mRNA platform of proven science, discovery, development, manufacturing, and commercialization, and position us for success as we continue to expand and advance our pipeline and build our 21st century immunotherapy powerhouse. With that, I would like to thank you all for your confidence in our success and your continued support and turn the call over to Erslan.
spk05: Thank you, Uwe.
spk03: I'm delighted to provide you with our COVID-19 vaccine and pipeline update to date. On slide 13, we have our multi-pronged innovation strategy to respond to the evolving pandemic and improve upon our vaccines with next-generation approaches that generate broader and more durable immunity. We have successfully delivered the first variant-adapted vaccine to address Omicron BA.1 and BA.4.5 variants. We believe that our vaccine has potential to be combined with a seasonal flu vaccine. Across many parts of the world, people are currently receiving the Omicron-adapted vaccine booster at the same time as their flu shot. Health agencies, including the U.S. CDC, now recommend co-administration of COVID-19 boosters with the annual influenza vaccine. A combination product has the potential to provide seasonal protection from both viruses with a single shot. We are working together with our partner Pfizer to develop an influenza combination vaccine which leverages our mRNA technology. In the midterm, we are also developing next-generation engineered vaccine candidates to expand the breadth of the immune response and provide more durable protection. This includes our T-cell enhancing vaccine candidate and engineered spike vaccine approaches. Our approach is supported by insights from continuous surveillance of variants and our robust clinical programs. On slide 14, our innovation strategy has already yielded success with our Omicron BA4, BA5 adapted bivalent vaccine approved for use in more than 45 countries and regions around the world. Through the rapid execution that Ugo highlighted, we are continuing to broaden the label of our Omicron BA4, BA5 adapted bivalent vaccine across different age groups. This includes FDA emergency use authorization for individuals aged 5 and older in the US. In the EU, we received EPC marketing authorization for individuals aged 12 and older. Submission for ages 5 to 11 years in the EU has been completed and we are awaiting CHMP recommendations. As a next step, we plan to submit data to regulatory agencies from our ongoing trials in age six months to four years in the first quarter of 2023 to extend access to our Omicron-adapted bivalent vaccine to young children. Our regulatory activities are supported by our ongoing clinical program, evaluating the BA.4.5 adaptive boosters in various age groups. Slide 15 highlights the positive data in the ages 18 and older cohort reported from the ongoing phase 2 free trial of our B4-5 adapted booster in individuals 12 years and up. The study was initiated in August and enrolled approximately 900 healthy volunteers aged 12 and older, all of whom had already received at least three doses of an approved COVID-19 vaccine. Adults received either 30 or 60 micrograms of our BA.4.5 adapted bivalent booster, although original vaccine as a comparator. Adolescents aged 12 to 17 received a 30 microgram dose, of the Omicron-adapted vaccine or the original vaccine. The data at the 30-day time point is from the Sentinel cohort, which included 40 people in each age group, 18 to 55 years of age, and older than 55 years, each having received the 30 microgram dose of the bivalent vaccine. The comparator group included 40 individuals over 55 years of age who received the original vaccine. The data showed that the safety and tolerability profile of the bivalent booster remains favorable and similar to the original vaccine. On slide 16, you can see the titers of neutralizing antibodies broken down by age group and by pre-vaccination status. While the 18 to 55-year-old had a 9.5-fold increase over baseline, for the group as a whole, the increase was notably higher, namely 16-fold, for those who were baseline negative. In the individuals who were older than 55 years, the group as a whole experienced a 13.2-fold increase in neutralization titers whereas the individuals who were negative at baseline experienced a 28.3-fold increase. These responses were higher than those observed in the comparator group receiving the original vaccine, who saw only a 2.9-fold increase over baseline. There was not much difference between the groups who were negative or positive at baseline in the comparator arm. The reference strain neutralization titers were at least as high as that observed in those who received the original vaccine. Overall, adults saw a substantial increase in response with the bivalent vaccine compared to the original vaccine, and the improvements were most pronounced in those over age 55, and those who were baseline negative prior to vaccination. Given that Omicron BA.4, BA.5, and their subvengers continue to be the dominant circulating strains, these data provide strong evidence of the protection that boosting with the bivalent vaccine can provide to adults, particularly the elderly. Slide 17, the second pillar of our innovation strategy includes our collaboration with Pfizer to develop a COVID-19 influenza combination vaccine based on BioNTech's validated mRNA technology. A phase one clinical trial has been initiated to evaluate the safety, tolerability, and immunogenicity of an mRNA quadrivalent influenza vaccine candidate in combination with our Omicron BA4, BA5 adapted bivalent vaccine. We are building on the experience made in the BNT161 program partnered with Pfizer, developing an influenza mRNA monovalent vaccine, for which a phase three trial was initiated by Pfizer in September. In the combination trial, the quadrivalent influenza vaccine candidate contains two type A strains and two type B strains that have been selected for the current season's traditional flu vaccine. 180 people aged 18 to 64 will be enrolled across six trial arms to test various combinations of the influenza vaccine candidate and the Omicron vaccine at 30 and 60 microgram doses. The influenza vaccine candidate individually and the standard license influenza vaccine as the comparator. Slide 18 details our two development tracks to create next generation vaccines. One track includes our engineered spike protein vaccine candidates. designed to elicit growth-neutralizing antibody protection against a vast array of variants, including those which have not yet evolved. The other track are vaccine candidates designed to enhance the T-cell response against SARS-CoV-2. Our first vaccine candidate for this program, BNT162B4, targets multiple highly conserved non-spike proteins that have been selected based on their potential to engage with T-cell arm of the immune system. This approach has the potential to increase immune resilience and enhance and broaden T-cell response and provide memory T-cell resistance and durability of B-cell response. A clinical trial start in combination with our Omicron BA.4, BA.5-adapted bivalent vaccine is expected in the coming weeks. Slide 19 highlights our infectious disease pipeline. In addition to the previously mentioned COVID-19 vaccine trial initiation, from the third quarter, we expect the start of multiple first-in-human trials of our mRNA vaccine candidates over the coming months. This includes our Shingles and HSP2 vaccine candidates, which are expected to enter the clinic in the final part of this year. Our malaria vaccine candidate trial, either in the fourth quarter of 2022 or early 2023, and our tuberculosis vaccine candidate expected to dose the first patient in early 2023. These programs build on our validated platform of nucleoside-modified mRNA LNPs with optimized backbone design to address diseases with a significant global need. Moving to our oncology program updates. Site20 provides an overview of our oncology pipeline that is grounded in our multi-modality toolbox and advanced focus execution. We now have a total of 19 oncology product candidates across four different drug classes in 24 ongoing clinical trials, five of which are randomized phase two trials. Our programs address areas of high unmet need and have the potential to tackle tumors using complementary strategies by targeting tumor cells directly or by modulating the immune response against the tumor. Many of our product candidates have potential to be combined with other pipeline assets. In the third quarter of 2022, three preclinical programs advanced to phase one clinical testing. This includes our fixer candidate, BNT116, for second-line treatment of non-small cell lung cancer, and our bispecific Scribomab product candidate, BNT142, for solid tumors. In collaboration with GenMAP, we recently initiated a Phase I study evaluating BNT313, our anti-CD27 hexabolic product candidate in solid tumors. At the ESMO Immuno-Oncology Congress in December 2022, we expect to have two presentations. One is about preliminary safety data from the safety run in part, of a study that precedes randomization in the ongoing phase two trial of our six-step program, BNT-113. This trial is evaluating BNT-113 in combination with pembrolizumab in patients with first-line HPV 16 positive, PD-L1 positive head and neck squamous cell carcinoma. The other is preliminary efficacy and safety data From another GenMAP collaboration, the phase one trial of BNT3-12, a CD40-4-1BB dual body in advanced solid tumors. Finally, we have BNT2-11, our next generation CAR-T therapy product candidate designed to overcome first generation CAR-T cell therapy limitations in patients with solid tumors. We recently presented follow-on data for BMT211 at the ESMO annual conference. The phase one dose escalation data continue to show encouraging clinical activity and safety. Turning to slide 21. BMT211 is a chimeric antigen receptor directing T cells against the novel target Claudine 6 that is tested alone and in combination with a CAR T-cell amplifying RNA vaccine called CARVAX, encoding sordine 6. CARVAX is based on our eugen mRNA lipoplex technology used in other cancer vaccine candidate programs. Sordine 6 CAR T-cell exists with a second generation chimeric antigen receptor of high sensitivity and specificity for the carcinoembryonic tumor-specific antigen Claudine-6. Claudine-6 is absent in healthy adult tissue, yet frequently expressed in high-medical need cancers, making this tumor antigen an ideal candidate for CAR T-cell therapy. The ongoing first-in-human Phase I-II trial is evaluating the safety and efficacy of Claudine-6 CAR T-cells as monotherapy and in combination with Kavak in patients with Claudine 6 positive, recessed or refractory advanced solid tumors. Our dose escalation study is testing three dose levels of Claudine 6 CAR-T cells as immunotherapy as well as in combination with a fixed dose of the RNA vaccine. The expansion cohorts include patients with ovarian, testicular, and endometrial cancers and rare Claudine 6 positive cancer types. Dive Center 2 provides a summary of the asthma presentation that includes data from 21 heavily pretreated patients who received Claudine 6 CAR T-cells at two dose levels, 10 to the 7th and 10 to the 8th, alone or in combination with CARVEC. Patients received lymphodepletion before treatment with BNT211 with the exception of two testicular cancer patients. The CAR T-cells as monotherapy and combined with CARVEC were well tolerated. Adverse events included manageable cytokine release syndrome and one transient grade 1 ICAMS. Those limiting toxicities were observed in two patients. Both were manageable and the patients fully recovered. One was prolonged cytopenia in the dose level 2 monotherapy group in a patient with testicular cancer after lymphodepletion. The second was hemophagocytic lymphohistocytosis in the dose level 2 combination group prior to application administration of CARBIC. The maximum tolerated dose has not yet been reached. We observed dose-dependent expansion of CARBIC in all patients. As of August 16th, Overall response rate was 33% and disease control rate was 67%. This includes one complete response, six partial responses, and seven patients with stable disease. We are particularly encouraged by the observed activity in patients with testicular cancer receiving the 10 to the 8th heart T-dose levels after lymphodepletion. Of seven evaluable testicular cancer patients included in the analysis, one had a confirmed complete response, three had partial responses, and two had stable disease, resulting in a disease control rate of 85% and an overall response rate of 57%. Slide 23 shows engraftment and expansion of infused CAR T-cells in all patients with persistent for more than 100 and, in some cases, 200 days, including in the patient with a complete response shown in blue. In cases of CAR T-cell redosing, the cells expand successfully, as shown here in the 10 to the 7th dose level. Slide 24 highlights particular cancer patients. where we saw encouraging signs of activity with impressive tumor shrinkage, as you can see in these CT scans. For 11 patients with casticular cancer who received lymphodepletion regimen, the response rate reached 45% and even 57% when looking only at the 10 to the 8th CAR T-cell dose. The disease control rate was 85% at the 10 to the 8th CAR T dose level. One patient at the 10 to the 8 CAR T dose level was assessed by the investigator as having a complete response at 12 weeks. This complete response continues and was confirmed at the 18-week and 52-week time form. We are very encouraged by the safety and clinical activity data from this promising program. Turning now to slide 25 and our next generation immune modulators partnered with GenMed. These programs, which aim to prime and activate anti-tumor T-cell and natural killer cell function, are continuing to advance. Abstracts for this conference were just announced earlier today. We will present a poster highlighting preclinical results supporting BNT311 or a bispecific antibody designed to elicit conditional 4-1-BZ co-stimulation concurrent with PD-L1 blockade. Additionally, an abstract of preclinical data demonstrating the mechanism of action of BNT313 has been accepted for poster presentation at SITC. BNT313 is an anti-CD27 antibody that carries a hexamerization-enhancing domain to support antibody hexamer transformation that drives CB27 clustering on the T-cell surface necessary for activation. BNT313 is designed to induce CB27 agonist activity without binding to SC gamma receptor-bearing cells and thus circumvent T-cell depletion. A Phase I clinical trial of BNT313 was initiated with Manu. As previously mentioned, for our BNT312 program, an abstract has been accepted for a presentation at the Ethno-Immuno-Oncology Congress in December. Overall, the progress of this program is very encouraging for us. I look forward to providing additional program updates in the coming months. I will now pass the presentation to our CFO, Jens Holstein, who will present our financial results.
spk15: Thank you, Aslam, and a warm welcome to those of you on the phone. I would like to begin by presenting the key financial highlights for the third quarter of 2022, which you can find on slide 27. Our total reported revenues for the third quarter reached 3.5 billion euros. Together with a strong first half year, we are in line with our prior year revenues for the year-to-date figures. I will elaborate on this shortly. Given this top line number, we delivered operating income of 2.4 billion euros and generated earnings per share on a fully diluted basis of 6 euros and 98 euro cents. With respect to the company's liquidity position, we ended the third quarter of 2022 with 13.4 billion euros of cash and cash equivalents, as well as trade receivables of around 7.3 billion euros. The trade receivables are primarily derived from our collaboration with Pfizer and remained outstanding due to the contractual settlement of the cross-profit share under the collaboration. As of October 15th, we collected 3.2 billion euros in cash from our outstanding trade receivables at September 30th, improving our cash position and in turn reducing our trade receivable position subsequent to the end of Q3. Continuing with slide 28, we recognized 3.4 billion euros of COVID-19 vaccine revenues during the third quarter and 12.9 billion euros during the first nine months. Revenues for the first nine months are in line with our expectations. We believe the development of the pandemic has been and remains dynamic, causing a refacing of orders and with this fluctuations in quarterly revenues. Let me give you some more details on our revenue streams. Under our COVID-19 vaccine collaborations, territories have been allocated between us, Pfizer and Fosun Pharma based on marketing and distribution rights. Our COVID-19 vaccine revenues included 2.5 billion euros for the third quarter and 9.1 billion euros for the first nine months that are related to our share of gross profit from COVID-19 vaccine sales in the collaboration partners' respective territories. These revenues represent a net figure, which means we generate 100% gross margin of those revenues. As we have mentioned in the past and explained in more detail in our financial statements and filings with the SEC, Our profit share is to some extent estimated based on preliminary data shared between our collaboration partner Pfizer and us. The gross profit share is also impacted by write-offs. So for example, for vaccine doses produced by our collaboration partner Pfizer. Those write-offs reduce the gross profit share between the two companies and therefore reduce BioNTech's revenue figure, but not those of our partner Pfizer. Our COVID-19 vaccine revenues from direct COVID-19 vaccine sales to customers in our territory were 0.6 billion euros for the third quarter and 2.3 billion euros for the first nine months. Those revenues were significantly driven by the orders that were placed in late 2021 following the then-emergent Omicron variant, and the Omicron adapted vaccine launches started beginning of September 2022. Also included in our COVID-19 vaccine revenues were 0.3 billion euros for the third quarter and 1.5 billion euros for the first nine months of revenues from sales to our collaboration partners. Now I'd like to move on to our detailed financial results for the third quarter and first nine months of 2022 as shown on slide 29. As I discussed revenues on the previous slide, let me move to cost of sales that reached approximately 0.8 billion euros in the third quarter of 2022 compared to 1.2 billion euros for the comparative prior year period. For the first nine months of 2022, the cost of sales reached approximately 2.8 billion euros compared to 2.3 billion euros for the comparative prior year period. The change in cost of sales resulted mainly from the recognition of costs related to our COVID-19 vaccine revenues in our own territories, including the share of gross profit that we owe to Pfizer. In addition, Cost of sales were impacted by expenses arising from inventory write-offs and expenses for production capacities derived from contracts with contract manufacturing organizations. Research and development expenses reached 341.8 million euros for the third quarter of 2022, compared to 260.4 million euros for the comparative prior year in 2021. For the first nine months of 2022, research and development expenses amounted to 1 billion euros compared to 0.7 billion euros for the comparative prior year period. The increase was mainly due to the increased headcount and higher expenses in the context of the share-based payments. General and administrative expenses reached 141 million euros for the third quarter of 2022 compared to 68.2 million euros for the comparative period in 2021. For the first nine months of 2022, General administrative expenses reached 361.8 million euros compared to 154.9 million euros for the comparative prior year period. The increase in G&A was mainly driven by the planned increase in headcount and increased expenses for purchased external services. Income taxes were accrued with an amount of 0.7 billion euros for the third quarter of 2022 compared to 1.5 billion euros for the comparative period in 2021. For the first nine months of 2022, income taxes were accrued with an amount of 2.6 billion euros compared to 3.2 billion euros for the comparative prior year period. The derived effective income tax rate for the first nine months of 2022 was 26.8%. In the third quarter of 2022, net profit reached 1.8 billion euros compared to 3.2 billion euros for the comparative period in 2021. In the first nine months of 2022, net profit reached 7.2 billion euros compared to 7.1 billion euros for the competitive prior year period. Our diluted earnings per share for the third quarter of 2022 amounted to 6 euros and 98 euro cents compared to 12 euros and 35 euro cents for the competitive period in 2021. For the first nine months of 2022, our diluted earnings per share was 27 euros and 70 euro cents compared to 27 euros and 46 euro cents in 2021. Now let's move to slide 30 for the outlook for the 2022 financial year. We are updating our 2022 financial guidance, raising our COVID-19 vaccine revenue estimate for the full year to the upper end of the original range, 16 to 17 billion euros from 13 to 17 billion euros previously. The narrowed guidance reflects delivery of the Omicron adapted bivalent vaccine booster which started early in September and is expected to continue throughout the fourth quarter of 2022, as well as higher prices and a positive foreign currency effect. We reiterate our planned expenses in CapEx, which we have summarized for you on the slide. We also update the estimated annual effective income tax rate from previously 28% to approximately 27%, which is a further improvement to previous years. I'll be moving to the completion of the first tranche of our share repurchase program as shown on slide 31. The share repurchase program approved by the management board and the supervisory board permits the repurchase of ADSs for a value of up to $1.5 billion over two years. Our intention is to use some or all of the repurchase ADSs to meet pending obligations from share-based payment arrangements. The first tranche of the repurchase program had a value of up to $1 billion and began on May the 2nd, 2022 and ended October the 10th, 2022. As shown on the slide, a total of 6,945,538 ESs were repurchased at an average price of 143.98 US dollars representing 2.8% of the shares issued as of April the 30th, 2022. In addition, we had paid out a dividend of approximately 0.5 billion euros to shareholders in 2022. In November, the second tranche of the repurchase program with a value of up to 0.5 billion dollars has been approved, commencing on December 7th this year. More information and an overview of the buybacks can be found on our IR website. With that, I would like to turn the call over to our Chief Strategic Officer, Ryan Richardson, for an update on our outlook for 2022 and concluding remarks. Thank you.
spk09: Thank you, Jens. Turning to slide 33, our COVID-19 vaccine continued to play a major role in addressing the pandemic with the launch of our variant-adapted B4, B5 vaccine. We and our partners have received approval in over 45 countries and territories since our first approval in August this year, and have rapidly deployed approximately 300 million doses of our variant-adapted vaccines as of mid-October. We have updated our full year 2022 order book and now expect to invoice up to 2.1 billion doses this year, reflecting some re-phasing of deliveries to early 2023 due to supply availabilities and projected uptake of our variant-adapted vaccines. By year end, we expect to fulfill both our existing contract with the United States government for 105 million doses and our contract with the European Union for 650 million doses. As we turn to 2023, we anticipate that the COVID-19 vaccine market will start the shift toward a hybrid public-private market, with some geographies, namely the United States, likely shifting to a commercial contracting model in 2023. In the United States, we and our partner Pfizer expect the list price for a single-dose vial of adult vaccine to be in the range of $110 to $130 per dose, reflecting both the cost effectiveness and public health value of our vaccine. In the future, we expect seasonal demand to be weighted to the second half of the year, consistent with other seasonal respiratory infectious disease vaccines. As shown on slide 34, we continue to make progress against our 2022 clinical milestones. As we enter the final months of the year, we expect a number of additional updates, some of which are shown here and on the following two slides. In infectious diseases, we expect continued expansion of our COVID-19 vaccine pipeline with multiple next generation vaccine constructs entering the clinic before year end. We also expect data updates from our ongoing clinical trials evaluating our variant adapted vaccines. Outside of COVID-19, we plan for multiple mRNA vaccines to enter the clinic this year and early next year. By the end of 2023, we expect to have up to five new clinical trial starts in infectious diseases. Turning to slide 35. In oncology, alongside the first patient dose in the Phase I trial evaluating BNT313, our anti-CD27 hexabody partnered with GENMAB, which we announced today. By year-end, we also expect to have the first patient dose for a second Phase I trial evaluating BNT116 in first-line NSCLC. We also will present a clinical data update at the ESMO-IO annual meeting in December for BNT312, our CD40-4-1BB dual-body partnered with GENMAB. As we look ahead to 2023, we expect a busy year for our oncology pipeline with as many as 10 clinical trial updates across a diverse range of programs. Concluding on slide 36, we expect 2023 to be a momentous year for BioNTech. We will continue to invest for the long term in our next generation COVID-19 vaccine pipeline as we continue to deliver our variant adaptive vaccine around the world. We will continue to expand and accelerate our innovative oncology and infectious disease pipelines in anticipation of multiple late-stage data readouts and clinical trial starts that we expect will fuel future growth. And with increasing balance sheet strength, which we expect into next year, we will continue to reinvest in the company to build world-class capabilities and accelerate our growth. We will also continue to look for additive bolt-on BD and M&A opportunities that fit with our strategy. We remain as optimistic as ever in our ability to continue to create long-term value for patients, our shareholders, and society. I would like to take the opportunity to thank our shareholders for their continued support and will now open the floor for questions.
spk06: Thank you. As a reminder, to ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. Please limit yourself to one question only. Once again, star one and one if you would like to ask a question. And please limit yourself to one question only. We will now go to our first question. One moment, please. And your first question comes from the line of Tanzine Ahmad from Bank of America. Please go ahead.
spk11: Hello, good morning. Thanks for taking my question. Can I just get some color from how long do you think that the current BA45 bivalent shot is going to be in use? Should we expect it to have any coverage of the newer variants, like, for example, the BQ1 or BQ1.1? And if it doesn't, how should we think about some of the shipments that you mentioned in your prepared remarks that have been shifted into 2023? Would those be delayed until later next year? Do the parties that have ordered have the right to delay shipment for a newer version of the vaccine?
spk07: Thanks.
spk03: I would like to respond to your first question, Tasim, with regard to how long the BA.4.5 Omicron adapted vaccines would allow us to respond to the pandemic. That will really depend on how the virus further evolves. Some of the currently emerging variants of concern are closely related with BA.4, BA.5 are from the BA.2 lineage and there is some probability that there will be cross neutralization and cross protection against these variants. We will continue to by cross-neutralization assays, which are ongoing, and can then say more. But it really depends on how the virus further evolves.
spk12: Ryan, do you want to take the second question, or should I give an answer?
spk09: Yeah, absolutely. I can start over. So, on the question of shifting of doses to Zine, A significant portion of those doses that were shifted for delivery next year were actually donation doses to a variety of countries around the world. So really we see that dynamic as not specifically related to the variant vaccine in question. And generally speaking, these contracts are flexible. So while we see some of those doses shifted to 2023, you know, we still have, expect a significant proportion of contracted doses next year and beyond. And that could be, those contracts could be served by, again, either the current vaccine or future vaccines if a future variant vaccine is needed.
spk11: Okay, great. Thanks for the color.
spk06: Thank you. We will now go to our next question. One moment, please. And your next question comes from the line of Matthew Harrison from Morgan Stanley. Hi, this is Steve from Matthew.
spk08: Thanks for taking my question. My question is, as you think about the PCP data next year, what kind of PFS difference would you like to see to think about moving it ahead? Thank you.
spk09: So just to clarify the question, you referenced the PCV. So you're talking about the INS program. Yes. Yeah, and melanoma. And your question, just to clarify, your question is what PFS improvement are we looking for?
spk08: Yes, yes.
spk09: Thank you. Okay. Ugraslam, do you want to address that?
spk12: Yeah, I think this is too early to define a threshold. We are working with hazard ratios. We have to understand whether any type of improvement is in line with the further progress in the field that was made in the first melanoma. We have to align this understanding also with the progress that we have made in the manufacturing of our INS platform. So we, in the meantime, improved the algorithm and reduced the turnaround time for the vaccine and came up with process improvements. And this would also require discussions with the authorities. to make the final decision whether we will pull gas and can just use the study to expand the clinical trial for potential accelerated approval or do a confirmatory trial.
spk07: Thank you.
spk06: Thank you. We will now go to our next question. And your next question comes from Chris from Goldman Sachs. Please go ahead.
spk14: Yes, thank you very much. Recent media reports suggest the potential for distribution of your COVID vaccine in China, with the initial target population being expats. As we're trying to better understand the potential scope of this opportunity, thinking in terms of units and pricing, Can you, number one, give us any updates on development when perhaps your vaccine might be approved in China? Number two, would this be an approval that might enable broader distribution to Chinese nationals? And then on the price front, help us at all with anything that we can understand about the potential pricing in that market. Thank you.
spk09: Yeah, thanks for the question, Chris. I think it's a little too early actually to give some specifics there. We have seen some positive, re-engagement as has been reported, and we can confirm that we have been, we've taken part in some discussions which are very positive. However, it's still too early to say or to try to predict to what extent an approval for the expat population could be granted, when it might be granted, what that would mean commercially. So at this stage, we're continuing to monitor the situation very carefully and hope to provide updates in the near future.
spk07: Thank you. We'll go to our next question.
spk06: One moment, please. And your next question comes from Jessica Faye from JP Morgan. Please go ahead.
spk16: Hey there. Good morning. Thanks so much for taking my question. On the COVID-19 vaccine market, Moderna has talked about how they expect the COVID booster market to be in the range of 500 to 600 million doses per year, not unlike flu, but potentially a bit below that in 2023. and working up to that 500 to 600 million thereafter. Do you share that view that COVID vaccine volumes could trail that 500 to 600 million range next year, but then increase in 24 and beyond to something closer to the flu range? Thank you.
spk15: Yeah, maybe I'll start with answering the question. You know, I think we all know that the pandemic has evolved throughout this year. And how it will evolve in the future is really very difficult to predict at this point in time. But we all know that COVID is a deadly disease. It's much more deadly than flu. We see much higher death rates, death cases than we know from flu. And elderly people and high-risk patients will be for sure the population that needs vaccinations. But of course, everyone else too who feels, you know, he or she needs to be protected against severe diseases. So that's maybe the base first. Going forward, I mean, all depends on, and how often additional variants will pop up and how severe those variants will be going forward. At some point, there is a high likelihood, of course, that there could be a flu-like business model coming up. It remains based on what I said before on the fact that COVID is a deadly disease, a large multi-billion dollar market going forward. And specifically with in such an endemic scenario that the private market opens up, we know that pricing will be very different to the current pricing that we had. So there is upside at that end. And in addition, maybe last comment from my end, I think BioNTech and Pfizer together have shown and have proven that we are well-placed in the market. We have, I think, a very good market position, and we have been able over the time to defend that market position very well. So we are very confident, you know, that going forward, this remains a very sizable, very good market for us. And Ryan, you maybe want to add something?
spk09: No, I think you covered most of it. I would just second the notion that 2023, we're not going to yet be into a true endemic market because it will be a hybrid market with significant contracted volumes and also expect emergence of a private market on top. I think the volume numbers that you've said are plausible. We have still seen evidence of higher uptake in the booster segment than, for example, we see with flu. um and and so there's one that's one data point there and obviously here we do expect a very different price point versus the flu market so i think those those factors combine to to create the the multi-billion long-term market opportunity that we expect the units just outlined thank you we'll now go to our next question and your question comes from
spk06: Dana Graybosh from SVB Layering. Please go ahead. Your line is open. Hi. Thanks for the question.
spk04: I want to ask about some academic publications that were posted as preprints from the Baruch and Holab frequently, and they were on their own looking at the immunogenicity of the bivalent boosters versus another boost of a wild-type monovalent. And their data showed pretty modest increases in antibody titers with the bivalent booster, much more modest than what you today have shown in the greater than 55 population. I wonder if you can talk about how you interpret their data and if their data, let's say, is correct in that you get a very modest difference with the bivalent, let's say, for younger people under 55. What does that tell you about the bivalent booster whether boosters will be needed and what kind of booster we may need in the future. Thank you.
spk12: Hi, Dana. Thank you for the question. So first of all, to the preprint, of course, we have studied the preprint, and we see that the study is missing to differentiate between individuals who had prior infection and without prior infection. And we have seen on our data set that this is really important to come to conclusions, since individuals without prior infection have a much higher higher increase with regard to the overall fault neutralizing titus as compared to those who have had prior infections. So our data, we have published seven-day data and one-month data, and the data are very consistent within the groups with homogeneous findings. We are confident that the report that we made also with a larger number of subjects, even very large, with a larger number of subjects, will turn out to be the real findings. So just to repeat, the key finding is that so far in the elderly population, we have a fourfold higher increase in neutralization status as compared to the biotype vaccines. And we are talking here about the immediate antibody response. What we have also to consider is that every vaccination with a variant-adapted vaccine has a second effect. The second effect is the induction with a clear delay of immune responses and forming of de novo B-cell responses that come up later in the timeframe of three plus months. So we believe that as in the flu case, we will need to have a booster market with variant-adapted vaccines to retrain the immune system to the new variant sequence. And this can't be addressed by sticking to the existing wild-type vaccine. Just to also repeat findings that were generated with the wild-type vaccine, even the booster with the wild-type vaccine reduces the severe disease rate and reduces the mortality. So that means regardless whether we are immunizing, boosting with biotype or with variant-adapted vaccines, We have a reduction of severe disease rate. And with the variant-adapted vaccines, we have now an evidence that the neutralization pattern appears to be significantly higher with the right type of vaccine.
spk07: Thank you. We will now go to our next question.
spk06: And your next question comes from the line of Akash Tiwari from Jefferies. Please go ahead. Your line is open.
spk02: Hey, good morning, everyone. This is Ivy for Akash. Thanks for taking our question. We have one on COVID vaccine sales. So how many of the total 1,300 million EU contracted doses remain to be delivered in 2023? Also, you mentioned some of your shipments have been pushed to next year. So in total, how many confirmed orders are there for next year? Consensus models 2023 total vaccine sales of around 10 billion. Do you feel you will be able to hit that number with your existing orders signed for 2023? Thanks.
spk09: Well, so, yeah, thank you for the question. I think I'll start and then I think again Celestia will chime in. So I think you first asked about next year and the EU contract. And I think what we announced in our prepared remarks was that we plan to deliver the planned doses for the EU this year that we plan for 2022 and also complete the U.S., existing U.S. contract that was announced earlier this year. We're not disclosing an order book number for next year. Of course, our overall signed orders have continued to grow throughout this year overall, regardless of the delivery time period. But we're not guiding at the moment to a future order book because we think it's premature to do so, and frankly, not relevant or not as relevant now, given that the demand picture continues to be dynamic, that we continue to expect the emergence of a private market in some geographies next year, as we mentioned. So it's really more of a hybrid market next year. But overall, we feel very good about overall demand and how we're tracking to be able to serve that.
spk15: Sorry, Ryan and myself had a little bit of a problem to understand you because the line connection was not that good. But as he pointed out correctly, we deliver according to the plan for 2022 for the EU. We're not expecting any shift here. We had, as you know, contractual agreements signed for 23 with the EU, 450 million doses and an option of 450 million doses. But as Ryan correctly said, I think maybe for the EU that might be at a later point in time. But overall, I think we've got to move away from this thinking on the order book, because what we have seen is there are certain shifts. It all depends on market demand, on the involvement of variants that are coming up. And specifically, as Ryan correctly said, there will be markets that move into a private setting going forward, assuming that you know, this is seen as an endemic market going forward. And it will take probably a few years. And then I think the danger really is to draw the wrong conclusions from some number on an order book. Yeah. And therefore, we are moving away from, you know, giving some guidances on this.
spk07: Got it. Thanks. Thank you. We'll now go to our next question.
spk06: And the next question comes from Yaron Verba from Cowan. Please go ahead. Your line is open. Hi.
spk01: This is Brendan on for Yaron. Thanks very much for taking the questions. Congrats on another strong quarter. So just a quick one from us. You know, when we think about maybe the emergence of future variants and look at kind of the timeline from the first Omicron wave in December and then BA.4.5 maybe around April or so, and then the rollout by September of your BA.4.5 booster, Do you think this is more or less a reasonable timeline we could expect for future variants in terms of your interactions with FDA and materials and data you'd need to get them really to get future boosters authorized? Or are there important considerations we should really be keeping in mind as the landscape inevitably shifts over the coming months and years?
spk12: uber do you want to take that yes i can i can take that i think the future vaccine adaptation and booster process will depend on two aspects one the regulatory landscape and in the and the second one is how fast we can respond to new new variants starting with the second part is As you know, the BA.4.5 variant emerged only recently, and after the FDA decisions, we were able to come up with an adapted vaccine and enable delivery within about two months. But that means our internal processes for vaccine adaptation and now even faster than what we had indicated beginning 2022. And we are going to further optimize the vaccine adaptation process to be able to respond quickly to a new variant. And the second thing, what is important is, and we have now the case with the FDA and with the EMA, we got an authorization of the vaccines based on pre-existing clinical data on multiple variants. And just to remind everyone, we have done multiple clinical trials with different variants And the safety profile that we have identified was always consistent for all variant-adapted vaccines. And the second aspect is that we found that preclinical data and clinical data in subjects with breakthrough infections are very protective on what they are seeing in the clinical setting. And the authorization now of this variant-adapted BA.4.5 vaccines followed this logic and enabled rapid authorization and availability of a BA.4.5 adapted vaccine. And we believe that this will become also in future the model, the working model. That means once new variants emerge, that require a boosting, we will be able to respond quickly, and there will be a regulatory process to allow that such variant-adapted vaccines can get, can be delivered within a few months after the emergence of the variants.
spk07: Okay, great. Thanks very much.
spk06: Thank you. We will now go to our next question. And the question comes from Ellie Merle from UBS. Please go ahead. Your line is open. Hey, guys. Thanks so much for taking the question.
spk17: Just a financial one. Given you booked the gross profits from the Pfizer collaboration, can you comment, I guess, on your latest thoughts on how you're thinking about the profit margin in the Pfizer collaboration COVID business longer term and how you see that changing and also how this could change if there were to be a combination COVID flu vaccine, for instance. Thanks.
spk15: Yeah, thanks, Elaine, for the question. Not an easy question to answer, I have to say. Well, in terms of the gross margin, I think you have seen pretty stable gross margin developments throughout the year. I mean, in the quarters, you have some ups and downs once in a while given that we had some write-offs, and we have elaborated on this in the documentation that we have published. Going forward, I mean, with the higher pricing, of course, it depends then what the costs are, what the costs will be that we have to deduct. It's a bit too early to really give you, you know, clear guidance on this, what that means for our gross margin for 23 in the years beyond, and specifically then when flu comes in, which, you know, will take a while. We will see that at a later point in time. So there will be some mixture that we will see going forward. And therefore, you know, you've got to bear with us a little bit until we're able to really give you some, some more clarity on the impact.
spk06: Got it. Thanks. Thank you. We will now go to the next question. And your next question comes from the line of Simon Baker from Redburn. Please go ahead. Your line is open.
spk10: A question on pricing, if I may. You very helpfully gave us the list price range for the US of around 110 to 130. per single dose. I appreciate it's not the same thing, but I just wonder how we should think about contrasting that number with the $64 per dose that CMS talked about in April. Obviously, yours covers a far broader remit than the CMS was talking about, but just how we can think about how those numbers triangulate together. And on a similar point, could you give us any early indications for pricing outside the US for 2023. Thanks so much.
spk09: Yeah, thank you, Simon. I mean, as you know, we're expecting this market to be a heavily tiered priced market like for any other vaccine. And so the price that we've quoted there is a US list price. We would expect, of course, that sometimes there can be differences depending on the segment that you're in. That's pretty much all we can tell you at this point. You know, in terms of the dynamic You know, we do think that this market will have some important differences to some of the other vaccine markets like Swoon in the sense that it's, you know, we expect that this will not be, this will be a branded market for the foreseeable future. And there's also a very different market structure here than you have in some of the other vaccine markets where you have many, many players. So I think we're, we do feel like we're in a good position here by virtue of having a very strong product with a very strong product profile, both on safety and efficacy. and have continued to build up our safety database and have a strong brand. So I think we feel good about the price that we put out there, but that's pretty much what we can say at this point. In some geographies, there could be differences, and there's likely to still be a link to volumes on some level, as you would expect in a heavily contracted market like this, where you have purchases in bulk.
spk15: And maybe to add to what Brian just said, I mean, you've heard what Pfizer said to the topic, you know, that pricing has been said given or in relation to what sort of benefit. you know, we see that we bring with the product. Of course, as Ryan said, you know, it's also a question of volume. So, I mean, we have signed huge contracts with various governments. The contract size with other parties in the U.S. market, to use that example, is, of course, a totally different one, and that will have an implication. Overall, I mean, how the pricing will develop over time is... to be expected to go up, of course, because more and more countries, if it becomes endemic, of course, that's the main assumption for this, you know, will then have similar sort of developments and what the pricing then means in Japan or in Europe, you know, when the European contract runs out, that has to be seen. It's a bit early to really be able to give you more precise indications here, but that's the sort of broad direction that we see.
spk10: Thank you very much.
spk06: Thank you. We will take one more question. And the question comes from the line of Chi-Yong Chang-Shu from Berenberg. Please go ahead. Your line is open.
spk13: Great. Thanks for taking the question. I want to ask broadly on the mRNA cancer vaccine. Obviously, there is some skepticism around the cancer vaccine space. So maybe, Ugar, can you Can you discuss a bit of your confidence on this modality in the cancer vaccine space and maybe some updated thoughts on where this modality will play the most significant role? And quick follow-up on BNT211, the CAR T. Can you also discuss the potential registration path for this program, given you have seen quite encouraging data from early trials. Thanks very much.
spk12: Thank you, Fian. So let's start with the cancer vaccine question, and Erslan will take the question related to the Chlorine 6 card. So, of course, the discussion about cancer vaccine is the same. Why do you believe that cancer vaccines will work in the background of so many failures in the past? So my answer is always the same. We believe that cancer vaccines must be positioned in a way that they can do the job. And we believe that the best market and the best indication and clinical setting to address cancer vaccines is post-surgery. where tumors are in a micrometastatic manner left. So this is minimal residual disease or ctDNA positive patients after surgery. And we know that in this setting, there is a huge medical need. To give you just examples, in colorectal cancer, about 30% of patients after surgery have a relapse in the time of two to three years after surgery. In triple negative breast cancer, this is also in the range of 30 to 40% in the first four years after surgery. In pancreatic cancer, it's even about 70% of patients. relapsing after surgery. And the same is similar data described for stomach cancer, GI cancers, and so on. That's where we want to position our personalized cancer vaccines, allowing us to induce new antigen-specific immune responses, T-SERVs. We know now from clinical data, early clinical data, in pancreatic cancer, in melanoma patients, and also from publications of other academic groups, that this could be an ideal setting to induce strong T cell responses that could help to control and eliminate residual tumor cells. And, Özlem, would you like to take the second question?
spk03: Yes. This was about our CAR T-cell program, BNT211, and the regulatory path which we would foresee there. Let me remind you that in this program we are still actually in the dose finding part of our phase one, two trial, which means that we have only tested the first two dose levels or three dose levels of our CAR T cells and are also still in the process of exploring whether adding to this new CAR T cell product vaccine makes a difference or not and how the treatment regimen should be. Having said that, we are also very excited as you about the data which we already see at this early stage, namely a manageable safety plus exciting clinical activity in particular in the patients with testicular cancer. Therefore, we have also started about thinking about the best regulatory path here. We have not made any decisions and cannot speak about that at this time point, but we'll for sure do next year.
spk14: Thank you very much.
spk06: Thank you. I will now hand the call back for closing remarks. Thank you for joining today's call. We look forward to talking to you soon.
spk05: Stay safe. Thank you and bye-bye.
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