This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk01: 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 issues this morning, both of which are accessible on our website in the investor section. As shown on slide two 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 timing 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 20F. Actual results could differ from those we currently anticipate. We are therefore cautioned not to place undue reliance on any forward-looking statements, which we only, as of today, share today during this conference call and webcast. Also, please note that slides three and four provide detailed and important safety information regarding our COVID-19 vaccine. I'm joined today by our CEO and co-founder, Ugo Zahin, Ersanem Tureci, our chief medical officer and co-founder, Jean Merritt, our chief business and commercial officer, Jens Holstein, our chief financial officer, Ryan Richardson, our chief strategy officer, and Sir Petting, our chief operating officer. I now turn the call over to Uwe Sahin.
spk04: Thank you, Silke. Good morning and good afternoon, and thank you to everyone joining the call today. Slide six, 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 continued to be strong as we transformed BioNTech and accelerate our pipeline of novel immunotherapies. I'm happy to report that we and our partner have crossed the one billion mark for COVID-19 vaccine doses shipped worldwide. We still have to 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 is having in addressing the global pandemic. We have also had a strong first half year in terms of the number of new trial starts in oncology as we accelerate development of our boat pipeline. We will go in further detail on some of these new trials in our prepared remarks. Moving to slide seven. Our strategy remains focused on developing a broad pipeline of next generation immunotherapies and vaccines and bring them to people worldwide to address unmet medical need in cancer, infectious disease, as well as in a growing list of other diseases. To accomplish this, we are building a fully integrated global immunotherapy company anchored around deep expertise in immunology and complemented by an expanding set of capabilities. To be more concrete what this means. In addition to shipping more than 1 billion doses of our first authorized product in the second quarter, we expanded our oncology pipeline to total 15 clinical stage programs and 18 ongoing trials. I expect our pattern to continue to broaden as we broaden our research and development and initiate additional clinical trials over the next 12 to 24 months. We are also increasing investment to strengthen our cost capabilities, including our digital technology spectrum. In the first half of the year, we have initiated a number of new research and development projects which aim to exploit the power of artificial intelligence and machine learning technologies across our research and development organization to discover and to optimize new immunotherapies. BioNTech will become a technology company of the coming age, exploring and exploiting innovations at the border of various rising technology fields. We believe in a future where our innovation can make a difference for many people around the world with diseases that cannot be effectively treated today. Finally, to accelerate the accomplishment of these objectives, we have continued to hire exceptional people around the world, going our firm to more than 2,500 team members in Europe, North America, and now Asia. We remain focused on innovating and accelerating our pipeline with the aim launching multiple products in the next five years. Slide eight 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 21st, we and our partner have signed supply contracts for delivery of approximately 2.2 billion doses in 2021. Further, we have committed to supply more than 2 billion doses of our vaccine to low- and middle-income countries between this year and the next. This is a considerable commitment that is only possible due to the investment we have made with our partners over the past 12 months to continuously increase our joint manufacturing capacity, now being well over 3 billion doses per year. In oncology, we have initiated six trials in the first half of 2021. This includes randomized phase two trials for our BNT111 six-pack in checkpoint inhibitory refractory melanoma, and for BNT113 six-pack HPV-positive head and neck cancer. For our INS program, BNT-122, we began screening patients in our Phase II trial for adjuvant colorectal cancer. In addition to this later stage trial, we initiated first in human trials for the first program from three novel platforms in the first half of the year. This includes our first CARVAC CAR-T cell program, our NeoSTEM ex vivo T-cell program, and the first program from our ribocytokine platform where we include cytokines in vivo using messenger RNA. All of these programs are targeting solid tumors and are wholly owned by BioNTech. We welcome Jens Holstein as our new CFO. We joined our executive management team on July 3rd. Jens is an accomplished executive who brings deep experience as financial steward and operator. His appointment will enable Zwerg to fully focus on his role as COO going forward. We recorded Q2 revenues of approximately 5.3 billion euros driven by the ramp up of the COVID-19 vaccine production and delivery worldwide. We recently announced the acquisition of CART's personalized TCR research and development platform and the clinical stage cell therapy manufacturing facility in Gettysburg, Maryland in the United States. This transaction strengthens our position in cell therapy by giving us a turnkey clinical stage cell therapy manufacturing site on both sides of the Atlantic. The site will support our going clinical stage therapy pipeline. The acquisition will also provide us with a team of more than 50 highly specialized therapy experts and personalized CCR platform, which complements our pipeline of individualized cancer therapies that we aim to build a long-term leadership position. Turning to slide nine. We see infectious disease as a long-term growth pillar for BioNTech. We believe the technology behind COVID-19 vaccine has the potential against a range of other infectious diseases as well as potential to play an important role in future pandemic preparedness programs. They are investing in mRNA vaccine programs to address diseases with a massive health burden. in particular in lower income countries, such as malaria, tuberculosis, and HIV. As part of this, we recently announced our plan to develop sustainable solutions to address infectious disease on the African continent. We aim to develop the first mRNA vaccines with durable, protective immunity for prevention of malaria with the initiation of a clinical trial by the end of 2022. Malaria is a disease that affects more than 200 million people worldwide every year, the worst affected being young children who have no immunity against this pathogen. Our malaria project is part of the eradicate malaria initiative by the Ken Abt Foundation. The second layer 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 supported by the joint convening powers of the WHO and the Africa Center for Disease Control and Prevention. Besides the WHO, the European Commission and other organizations have been involved in the early planning phase of our malaria project and offer their support to identify and set up needed infrastructure. As a reminder, we have multiple product candidates in preclinical development for tuberculosis and HIV in collaboration with the Bill and Melinda Gates Foundation. We plan to start the clinical trial for our tuberculosis vaccine candidate in 2022, only about 2.5 years after initiation of the research program. As part of our collaboration with the University of Pennsylvania, we are developing up to 10 messenger RNA vaccine candidates for various infectious diseases with unmet medical needs. With multiple programs and preclinical developments, we expect to bring the first product candidate in the clinic by the next year. Finally, BNT161, the influenza vaccine program. Our partner, Pfizer, expects to initiate the first in-human trial in the third quarter of 2021. We are eligible to receive milestone payments and up to double-digit royalties for this program through our licensing agreement with Pfizer. On slide 10, we show a depiction of the toolkit we are building across our technology platform, which includes 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 even developing new complementary approaches which 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 allergy autoimmune disease and inflammatory diseases and even regenerative medicine we believe that the new product paradigms that 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 has the potential to improve efficacy or producibility beyond what has been achievable with other vaccine modalities. You also see the opportunity for new modalities such as mRNA therapeutic cancer vaccines or immunotherapies based on mRNA encoded proteins, such as our RiboMap and Ribocytopenia. And finally, we believe our toolkit could lead to new disruptive modalities at the intersection of mRNA and cell therapy, such as our CARVAC approach, where we use mRNA to address T cell persistence in vivo. We will continue to combine our immuno-oncology expertise and powerful suite of technologies to unlock this new therapeutic universe of opportunity. I will now turn the call over to Sean, who will provide updates on our COVID-19 program.
spk03: Thanks, Ugo. It's a pleasure to be speaking with everyone today. Our partnerships with Pfizer and Folsom 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 a leading provider of COVID-19 vaccines globally, the demand for our vaccine remains high. We have a strong order book in place for 2021 and several contracts already signed for 2022 and beyond. shown on slide 13. Discussion for additional contracts remains ongoing. As of 21st of July, we, along with Pfizer, have secured orders for approximately 2.2 billion doses of the vaccine to be delivered in 2021. We expect the number of doses to continue to grow through additional orders. For example, we recently announced that the U.S. government purchased an additional 200 million doses, bringing the total number of doses under the existing supply agreement to 500 million. We expect to deliver 110 million of the additional doses by December 31, 2021, and the remaining 90 million doses no later than April 20, 2022. We also have a contract to supply 900 million doses to the European Union for the years 2022 to 2023 inclusive, with an option for an additional 900 million doses. This is a historic development, as it is the largest supply contract in the history of the pharmaceutical industry. We have also contracted for more than 1 billion doses of our COVID-19 vaccine to date for 2022 and beyond. Both the United States government and the European Commission also have the option to acquire an updated version of the vaccine to address potential variants and also new formulations, if available and authorised. 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 Ugo mentioned, we have pledged 2 billion doses over the next 18 months to ensure global equitable vaccine access. This includes our plan to provide the US government 500 million doses of our COVID-19 vaccine at a not-for-profit price of which 200 million doses are in 2021 and 300 million doses are in the first half of 2022. The U.S. government will, in turn, donate the Pfizer-BioNTech vaccine doses to low- and middle-income countries and organizations that support them. This will further support the multilateral efforts to address the surge of infection in many parts of the world. Recently, we, along with our partner Pfizer, announced that we had signed a letter of intent to collaborate with BioVac for the manufacture and distribution of our COVID-19 vaccine in Africa. All vaccine doses manufactured at this new CMO site will exclusively be distributed within the 55 member states and make up the African Union. Moving now to slide 14. As we've done on previous calls, I will provide an update of our key 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 immediately 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 population, we are pleased that we have received expanded authorizations for adolescents 12 years of age and older in the United States, the European Union, and many other countries. As we have discussed in detail previously, we have multiple ongoing clinical trials to support further label expansions, including in pregnant women and in children aged six months to 11 years. We expect data from the study in children two to 11 years in the third quarter of this year, and data from children six months to two 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 five to 11 years old in the September to October 2021 timeframe, and soon after for children six months to five years. On the regulatory front, our USBLA submission for our COVID-19 vaccine was recently accepted by the FDA and granted priority review designation. The Prescription Drug User Fee Act or PDUFA date for a decision by the FDA is in January 2022. The BLA includes clinical data from the pivotal phase three trial of the vaccine where the vaccine's efficacy and favorable side effect profile were observed up to six months after the second dose. They're 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 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 viral variants, we have expanded trials to expand both variant-specific versions of BNT162b2, as well as a third dose of BNT162b2 given six to 12 months after the second dose. Initial data from the BNT162b2 booster trial have been recently disclosed, and Özlem will now provide you further details on our boosting and variant strategy. I'll now turn the call over to Özlem.
spk02: Thank you, Sean. To pick up where Sean stopped, we believe that duration of vaccine-induced protection and cross-protection against variants are interdependent outcomes. Slide 15 shows follow-up data from our landmark trial that enrolled more than 46,000 participants at more than 150 sites around the globe. These data show vaccine efficacy to remain high, 91.2%, for up to six months following the dose two 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. In the trial, vaccine efficacy against Severe disease at six months after the second dose is 95.7%. In 800 participants in South Africa, where the Beta variant was prevalent at that time, nine cases of COVID-19 with eight 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 six. One is neutralizing antibodies. We constantly assess error from vaccine recipients in the trial for ability to neutralize emerging variants. There are some participants who received two doses of BNT162b2 demonstrate preserved in vitro neutralizing activity against several variants of concern, including Delta and Delta-related ones, as shown in the left panel. While the neutralization titers against Delta appear lower than against the original strain, USAWA 2020, the neutralization is still 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 key cells are shown and aligned for five SARS-CoV-2 lineages in the figure on the top right, showing 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 that helps to assess protection 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 a vaccine effectiveness against symptomatic infection from Delta of 87% and 100% protection against hospitalization. A nationwide surveillance 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% 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 Israel. We believe that another important factor is the early start date of Israel's vaccination program relative to the rest of the world, and that many high-risk populations had received their second dose more than six months prior July ago, which increases the risk of infection in these individuals. So the point I want to make is, 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 Varieties across different geographies such as public health measures and restrictions that are in place will also have an impact on how this plays out in the real world setting. Continued monitoring of real world data and immunogenicity data is warranted to understand when a booster or a variant adapted vaccine will be required, which of course is at the discretion of global health authorities. To be prepared for the scenario that a response to a variant of concern may become necessary soon, we are establishing preemptively a development and regulatory pathway for a variant-specific prototype approach, as shown on slide 17. This approach also aims to address the question whether boosting with the ancestral BNT162b2 only may suffice or variant adaptations may be required. Our prototype approach includes four work streams. The first to evaluate a third dose of BNT162b2 in fully BNT162b2 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 assessed for efficacy of a third dose of BNT162b2 with data expected in Q4 this year. The third ongoing trial evaluates safety and immunogenicity of BNT162b2 or a better variant-specific vaccine version of it in 300 fully 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. Also, we are planning to start a trial that will evaluate a delta-variant-specific version, an alpha-variant-specific version, and also multivalent vaccine, including both versions of BNT162b2. This trial will include about 600 vaccinated participants and 300 naive participants. Data from the trial is expected in Q4. We expect the data from these trials to significantly enlarge our knowledge about vaccine protection and variants of concern and also help to inform the optimal path going forward. Pieces of data from our comprehensive endeavor are in fact already available. Recently published data from the first work stream is shown on slide 18, evaluating the administration of a third BNT162b2 dose seven to nine months after dose two. The graph on the top right shows that in elderly adults neutralization has almost fallen to the level of detection by this assay after seven to nine months. Boosting with a third dose between seven and nine months after dose two induces a robust neutralization response beyond what was originally observed after dose two. Serra obtained from participants one month after this dose three elicits high neutralization titers against the original ancestral strain and also against the beta variant and the delta variant. Neutralization titers against the delta variant are over five-fold over those observed after dose two in the age group 18 to 55 years and even over 11-fold in the older age group 65 to 85 year old. as shown in the graph on the bottom right. Furthermore, the difference in
Disclaimer