BioNTech SE (NASDAQ:BNTX) Q4 2021 Earnings Conference Call March 30, 2022 8:00 AM ET Company Participants Sylke Maas - Vice President of Investor Relations & Strategy Ugur Sahin - Chief Executive Officer & Co-Founder Ozlem Tureci - Chief Medical Officer & Co-Founder Jens Holstein - Chief Financial Officer Ryan Richardson - Chief Strategy Officer Sean Marett - Chief Business & Commercial Officer Conference Call Participants Cory Kasimov - JPMorgan Tazeen Ahmad - Bank of America Matthew Harrison - Morgan Stan ...

Exhibit 99.1 BioNTech Announces Fourth Quarter and Full Year 2021 Financial Results and Corporate Update 1 1 • Fourth quarter and full year revenues of €5.5 billion and €19.0 billion , respectively 2 • Full year net income of €10.3 billion and fully diluted earnings per share of €39.63 ($46.87 ) • Expect to authorize a share repurchase program of up to $1.5 billion over the next two years and will propose a special cash dividend of €2.00 per share, pending approval at the Annual General Meeting • Approximat ...

[Executive Summary & 2022 Outlook](index=1&type=section&id=Executive%20Summary%20%26%202022%20Outlook) [Q4 and Full Year 2021 Highlights](index=1&type=section&id=Q4%20and%20Full%20Year%202021%20Highlights) BioNTech achieved significant financial results in Q4 and full-year 2021, driven by global deliveries of its COVID-19 vaccine, and announced capital return initiatives while expanding its clinical pipeline Key Financial Data for Q4 and Full Year 2021 | Metric | Q4 2021 (billion EUR) | Full Year 2021 (billion EUR) | | :--- | :--- | :--- | | Revenues | 5.53 | 19.00 | | Net Profit | 3.17 | 10.30 | | Diluted EPS (€) | 12.18 | 39.63 | - The company expects to authorize a share repurchase program of up to **$1.5 billion** over the next two years and proposes a special cash dividend of **€2.00 per share**[3](index=3&type=chunk) - In 2021, approximately **2.6 billion doses** of COMIRNATY/BNT162b2 were delivered to over 165 countries and regions, with more than **1 billion doses** supplied to low- and middle-income countries[3](index=3&type=chunk) - BioNTech's 2022 COVID-19 vaccine revenue guidance is reaffirmed at **€13 billion to €17 billion**[3](index=3&type=chunk) - The oncology clinical pipeline has expanded to **16 clinical programs**, with nine clinical trials initiated, including four randomized Phase 2 trials[3](index=3&type=chunk) [CEO Statement](index=1&type=section&id=CEO%20Statement) The CEO reflects on 2021's achievements with the first approved mRNA vaccine and outlines future investments in mRNA immunotherapies, cell therapies, and infectious diseases to improve global health - 2021 was an exceptional year for BioNTech, marking a significant impact on human health and the global economy with its first approved mRNA-based vaccine[4](index=4&type=chunk) - The company plans to build on its 2021 success by rapidly advancing multiple programs, including mRNA immunotherapies, cell therapies, and bispecific antibodies[4](index=4&type=chunk) - BioNTech is investing in its second growth pillar, infectious diseases, and plans to advance influenza and shingles vaccine candidates with its partner Pfizer[4](index=4&type=chunk) - The company also plans significant investments in regenerative medicine and autoimmune diseases to develop further therapeutic innovations for high unmet medical needs[4](index=4&type=chunk) [Key Financial Results & Outlook](index=2&type=section&id=Key%20Financial%20Results%20%26%20Outlook) BioNTech reported strong financial performance for Q4 and full-year 2021, driven by COVID-19 vaccine revenues, and plans significant R&D investment increases and capital returns for 2022 Key Financial Data for Q4 and Full Year 2021 | Metric | Q4 2021 (million EUR) | Q4 2020 (million EUR) | Full Year 2021 (million EUR) | Full Year 2020 (million EUR) | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | 5,532.5 | 345.4 | 18,976.7 | 482.3 | | Net Profit | 3,166.2 | 366.9 | 10,292.5 | 15.2 | | Diluted EPS (€) | 12.18 | 1.43 | 39.63 | 0.06 | - R&D expenses for the 2022 financial year are estimated to be between **€1.4 billion and €1.5 billion**, an increase of approximately 50% compared to 2021[5](index=5&type=chunk) - A share repurchase program of up to **$1.5 billion** is planned, along with a proposed special cash dividend of **€2.00 per share**[5](index=5&type=chunk) FY 2022 BioNTech COVID-19 Vaccine Revenue Guidance | Metric | Amount (billion EUR) | | :--- | :--- | | Estimated BioNTech COVID-19 Vaccine Revenues | 13 - 17 | FY 2022 Planned Expenses and Capital Expenditures | Metric | Amount (million EUR) | | :--- | :--- | | R&D Expenses | 1,400 - 1,500 | | SG&A Expenses | 450 - 550 | | Capital Expenditures | 450 - 550 | - The estimated annual effective income tax rate for the BioNTech Group in fiscal year 2022 is expected to be approximately **28%**[9](index=9&type=chunk) [Capital Allocation Framework](index=4&type=section&id=Capital%20Allocation%20Framework) BioNTech's capital allocation framework leverages its COVID-19 vaccine success to drive a multi-platform strategy, focusing on R&D, M&A, infrastructure, and capital returns to shareholders - **R&D Activities**: Develop next-generation COVID-19 vaccines and expand the pipeline into autoimmune, inflammatory, cardiovascular, neurodegenerative diseases, and regenerative medicine[10](index=10&type=chunk) - **M&A and Business Development**: Strengthen technology platforms and digital capabilities through strategic collaborations and acquisitions to enhance infrastructure and manufacturing[11](index=11&type=chunk) - **Corporate and Infrastructure**: Scale the organization, expand presence in key global regions (Europe, US, Asia, Africa), invest in key technology manufacturing, and deploy pandemic preparedness capabilities[11](index=11&type=chunk) - **Capital Return to Shareholders**: Authorize a share repurchase program of up to **$1.5 billion** and propose a special cash dividend of **€2.00 per share** at the 2022 Annual General Meeting[11](index=11&type=chunk)[13](index=13&type=chunk)[14](index=14&type=chunk) [Detailed Financial Results (Q4 & FY 2021)](index=5&type=section&id=Detailed%20Financial%20Results%20(Q4%20%26%20FY%202021)) [Revenues](index=5&type=section&id=Revenues) BioNTech's revenues surged in Q4 and full-year 2021, primarily driven by strong demand for its COVID-19 vaccine, including gross profit share, sales milestones, and direct vaccine sales Total Revenues (million EUR) | Period | Q4 2021 | Q4 2020 | Full Year 2021 | Full Year 2020 | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | 5,532.5 | 345.4 | 18,976.7 | 482.3 | - Q4 2021 commercial revenues included **€4.5822 billion** from gross profit share and **€43.8 million** from sales milestones[15](index=15&type=chunk) - Full-year 2021 commercial revenues included **€14.3521 billion** from gross profit share and **€476.6 million** from sales milestones[15](index=15&type=chunk) - Product sales revenue of **€456.6 million** (Q4) and **€970.9 million** (FY) was recognized for products manufactured by BioNTech for its partners, alongside **€421.0 million** (Q4) and **€3.0072 billion** (FY) from direct COVID-19 vaccine sales[15](index=15&type=chunk) [Cost of Sales](index=5&type=section&id=Cost%20of%20Sales) The company's cost of sales increased significantly in Q4 and full-year 2021, mainly related to COVID-19 vaccine sales and the gross profit share payable to Pfizer Cost of Sales (million EUR) | Period | Q4 2021 | Q4 2020 | Full Year 2021 | Full Year 2020 | | :--- | :--- | :--- | :--- | :--- | | Cost of Sales | 583.2 | 41.0 | 2,911.5 | 59.3 | - In Q4 and full-year 2021, **€565.5 million** and **€2.8556 billion**, respectively, of cost of sales were related to BioNTech's COVID-19 vaccine sales and included the gross profit share payable to Pfizer[16](index=16&type=chunk) [Operating Expenses](index=5&type=section&id=Operating%20Expenses) [Research and Development Expenses](index=5&type=section&id=Research%20and%20Development%20Expenses) R&D expenses rose in Q4 and full-year 2021 due to increased clinical trial activities for the BNT162 COVID-19 vaccine, higher personnel costs, and recognition of share-based payments Research and Development Expenses (million EUR) | Period | Q4 2021 | Q4 2020 | Full Year 2021 | Full Year 2020 | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | 271.5 | 257.0 | 949.2 | 645.0 | - The increase was mainly driven by a rise in clinical trials for the **BNT162 COVID-19 vaccine** in 2021[18](index=18&type=chunk) - Higher wages, benefits, and social security expenses from increased headcount, along with recognition of share-based payments and inventor remuneration, also contributed to the growth[18](index=18&type=chunk) [General and Administrative Expenses](index=6&type=section&id=General%20and%20Administrative%20Expenses) General and administrative expenses grew substantially in Q4 and full-year 2021, driven by increased personnel costs, share-based payments, consulting fees, and higher insurance premiums General and Administrative Expenses (million EUR) | Period | Q4 2021 | Q4 2020 | Full Year 2021 | Full Year 2020 | | :--- | :--- | :--- | :--- | :--- | | G&A Expenses | 130.9 | 35.9 | 285.8 | 94.0 | - The increase was primarily due to higher wages, benefits, and social security expenses from increased headcount, as well as share-based payments[19](index=19&type=chunk) - Increased expenses for purchased management consulting and legal services, along with higher insurance premiums due to increased business volume, were also contributing factors[19](index=19&type=chunk) - The company's M&A and business development transactions also led to an increase in general and administrative expenses[19](index=19&type=chunk) [Income Taxes](index=6&type=section&id=Income%20Taxes) BioNTech recorded significant income tax expenses for Q4 and full-year 2021, a shift from the tax benefits in the prior year, resulting in a 31.6% effective tax rate for the full year Income Taxes (million EUR) | Period | Q4 2021 | Q4 2020 | Full Year 2021 | Full Year 2020 | | :--- | :--- | :--- | :--- | :--- | | Income Taxes | (1,547.7) | 161.3 | (4,753.9) | 161.0 | - The annual effective income tax rate for the year ended December 31, 2021, was **31.6%**[20](index=20&type=chunk) [Net Profit](index=6&type=section&id=Net%20Profit) The company achieved substantial net profit growth in Q4 and full-year 2021, reflecting the immense success of its COVID-19 vaccine Net Profit (million EUR) | Period | Q4 2021 | Q4 2020 | Full Year 2021 | Full Year 2020 | | :--- | :--- | :--- | :--- | :--- | | Net Profit | 3,166.2 | 366.9 | 10,292.5 | 15.2 | [Cash, Cash Deposits and Trade Receivables](index=6&type=section&id=Cash%2C%20Cash%20Deposits%20and%20Trade%20Receivables) As of year-end 2021, BioNTech held substantial cash and receivables, primarily from its gross profit share with Pfizer, a portion of which was collected post-period Cash and Receivables (million EUR) | Metric | As of December 31, 2021 | | :--- | :--- | | Cash and Cash Equivalents | 1,692.7 | | Cash Deposits | 375.2 | | Total Trade Receivables | 12,381.7 | - Of the outstanding trade receivables as of December 31, 2021, **€4.6936 billion** was received in cash on January 16, 2022[22](index=22&type=chunk) [Shares Outstanding](index=7&type=section&id=Shares%20Outstanding) The total number of shares outstanding for BioNTech was 242,521,489 as of December 31, 2021 Number of Shares Outstanding | Metric | As of December 31, 2021 | | :--- | :--- | | Shares Outstanding | 242,521,489 | [Program Updates](index=7&type=section&id=Program%20Updates) [COVID-19 Vaccine Program (BNT162b2)](index=7&type=section&id=COVID-19%20Vaccine%20Program%20(BNT162b2)) BNT162b2, the first approved mRNA product, achieved tremendous success in 2021, with ongoing global delivery, new formulation development, and expanded regulatory approvals to address the evolving pandemic - BNT162b2 is the first approved mRNA product and has been administered to over **1 billion people** worldwide[26](index=26&type=chunk) [Commercial Updates](index=7&type=section&id=Commercial%20Updates) As of early March 2022, BioNTech and Pfizer have delivered over 3.1 billion doses of BNT162b2 to over 170 countries, with approximately 1.3 billion doses supplied to low- and middle-income countries - As of early March 2022, over **3.1 billion doses** of BNT162b2 have been delivered to more than 170 countries and regions worldwide[27](index=27&type=chunk) - As of early March 2022, approximately **1.3 billion doses** have been delivered to low- and middle-income countries[27](index=27&type=chunk) - As of mid-March 2022, BioNTech and Pfizer have signed orders for approximately **2.4 billion vaccine doses** for 2022[27](index=27&type=chunk) - A new vaccine formulation was launched that can be stored for **10 weeks** at refrigerator temperatures (2°C to 8°C) and for 12 hours at 2°C to 30°C after first puncture, which has been delivered to over 50 countries[28](index=28&type=chunk) - An agreement was reached with the European Commission for an additional **200+ million vaccine doses**, bringing the total doses delivered to EU member states in 2022 to over 650 million[29](index=29&type=chunk)[31](index=31&type=chunk) [Manufacturing Updates](index=8&type=section&id=Manufacturing%20Updates) BioNTech and Pfizer's global COVID-19 vaccine supply chain and manufacturing network includes 20 production facilities across four continents, ensuring global vaccine supply - The global COVID-19 vaccine supply chain and manufacturing network includes **20 production facilities** across four continents[32](index=32&type=chunk) [Clinical Development and Research Updates](index=8&type=section&id=Clinical%20Development%20and%20Research%20Updates) The company continues clinical development and research for its COVID-19 vaccine, including expanding vaccination to younger populations, evaluating booster doses, and developing Omicron-based vaccine candidates - In the pivotal Phase 3 trial in adolescents 12 to 16 years of age, **100% vaccine efficacy** was observed from 7 days to 4 months after the second dose[36](index=36&type=chunk) - The trial for children 6 months to under 5 years of age was amended to include a third 3 µg dose, with data expected in **April 2022**[37](index=37&type=chunk) - A clinical trial for an **Omicron-based vaccine** has been initiated to evaluate safety, tolerability, and immunogenicity, with data expected in April 2022[40](index=40&type=chunk) - A combination of a bivalent Omicron vaccine and BNT162b2 is also being evaluated[40](index=40&type=chunk) [Regulatory Updates](index=9&type=section&id=Regulatory%20Updates) BioNTech and Pfizer's COVID-19 vaccine has received multiple global regulatory approvals, including expanded Emergency Use Authorizations (EUA) for booster doses and primary series in various age groups - The U.S. FDA expanded the EUA to include a booster dose for individuals 18 years and older, later extending it to those 16+ and 12+[42](index=42&type=chunk)[44](index=44&type=chunk) - The European Commission approved the vaccine for children 5 to under 12 years of age, based on **90.7% vaccine efficacy** in a Phase 3 trial[43](index=43&type=chunk) - The U.S. FDA expanded the EUA to include a third primary series dose for immunocompromised individuals aged 5 to under 12[45](index=45&type=chunk) - The U.S. FDA requested the initiation of a rolling submission for a three-dose primary series in children 6 months to under 5 years of age[47](index=47&type=chunk) - The European Commission approved BNT162b2 as a booster dose for adolescents 12 to under 18 years of age[48](index=48&type=chunk) - The EU product information was updated to include the use of the vaccine during pregnancy and breastfeeding[49](index=49&type=chunk) - The U.S. FDA expanded the EUA to include a second booster dose for individuals 50 years and older and certain immunocompromised individuals 12 years and older[49](index=49&type=chunk) [Additional Infectious Disease Programs](index=10&type=section&id=Additional%20Infectious%20Disease%20Programs) Infectious diseases represent a long-term growth pillar for BioNTech, which aims to become a leader in mRNA vaccines by advancing a pipeline targeting influenza, shingles, malaria, and other high-need diseases - Infectious diseases are a long-term growth pillar for BioNTech, with the goal of becoming a leader in the field of mRNA infectious disease vaccines[50](index=50&type=chunk) - The company is advancing an mRNA vaccine and therapy pipeline against multiple high-need indications, including influenza, shingles, malaria, tuberculosis, HSV 2, and HIV[50](index=50&type=chunk) [Influenza Vaccine Program](index=10&type=section&id=Influenza%20Vaccine%20Program) BioNTech is collaborating with Pfizer to develop an mRNA-based influenza vaccine, with Phase 1 data for BNT161 expected in the first half of 2022 and a new saRNA study planned - Phase 1 clinical trial data for **BNT161** (modified mRNA vaccine) are expected in the first half of 2022[51](index=51&type=chunk) - A clinical study of a self-amplifying mRNA (saRNA) influenza vaccine is planned to evaluate safety, tolerability, and immunogenicity[53](index=53&type=chunk) [Shingles Vaccine Program](index=11&type=section&id=Shingles%20Vaccine%20Program) BioNTech and Pfizer have signed a new global agreement to co-develop the first mRNA-based shingles vaccine candidate, with clinical trials planned to start in the second half of 2022 - A global agreement was signed with Pfizer to develop the **first mRNA-based shingles vaccine candidate**[54](index=54&type=chunk) - Clinical trials are planned to start in the **second half of 2022**[55](index=55&type=chunk) [Malaria Vaccine Program](index=11&type=section&id=Malaria%20Vaccine%20Program) BioNTech plans to develop an mRNA malaria vaccine candidate aimed at preventing malaria and related mortality, with clinical trials scheduled to begin in the second half of 2022 - The company plans to develop an mRNA vaccine candidate to prevent malaria and related mortality[56](index=56&type=chunk) - Clinical trials for the mRNA malaria vaccine are planned to start in the **second half of 2022**[56](index=56&type=chunk) [Tuberculosis Vaccine Program (BNT164)](index=11&type=section&id=Tuberculosis%20Vaccine%20Program%20(BNT164)) Since 2019, BioNTech has collaborated with the Bill & Melinda Gates Foundation to develop the tuberculosis vaccine candidate BNT164, with clinical trials planned for the second half of 2022 - The company has been collaborating with the Bill & Melinda Gates Foundation since 2019 to develop a tuberculosis vaccine candidate[57](index=57&type=chunk) - Clinical trials for the tuberculosis vaccine candidate are planned to start in the **second half of 2022**[58](index=58&type=chunk) [HSV 2 Vaccine Program](index=11&type=section&id=HSV%202%20Vaccine%20Program) BioNTech is developing an HSV 2 vaccine candidate in collaboration with the University of Pennsylvania, with clinical trials expected to start in the second half of 2022 - An HSV 2 vaccine candidate is being developed in collaboration with the University of Pennsylvania[59](index=59&type=chunk) - Clinical trials are expected to start in the **second half of 2022**[59](index=59&type=chunk) [Oncology Pipeline](index=12&type=section&id=Oncology%20Pipeline) BioNTech's immuno-oncology strategy employs a diverse toolkit of complementary approaches, advancing 16 product candidates into 20 ongoing clinical trials in 2021 - BioNTech's oncology pillar includes mRNA therapeutic vaccines, CAR-T immunotherapies, cell therapies, individualized neoantigen specific immunotherapies, RiboMabs, next-generation checkpoint immunomodulators, anti-tumor antibodies, and small molecules[61](index=61&type=chunk) - The company has a library of over **300 proprietary or known shared antigens** and has developed predictive algorithms for efficient identification of individualized neoantigens[62](index=62&type=chunk) - In 2021, the company advanced **four immuno-oncology programs** into randomized Phase 2 studies and initiated five first-in-human trials, bringing the clinical pipeline to 16 product candidates in 20 ongoing clinical trials[63](index=63&type=chunk) [mRNA Programs](index=12&type=section&id=mRNA%20Programs) BioNTech's mRNA oncology programs include FixVac, iNeST, and RiboMabs, which utilize proprietary mRNA backbones and delivery technologies to develop off-the-shelf and individualized cancer treatments - **FixVac** product candidates use the company's proprietary immunogenic mRNA backbone encoding cancer-specific shared antigens and are administered intravenously using the RNA-LPX delivery formulation[64](index=64&type=chunk) - **iNeST** is an individualized cancer immunotherapy targeting patient-specific neoantigens present in tumors, developed in collaboration with Genentech[70](index=70&type=chunk)[71](index=71&type=chunk) - **RiboMab** product candidates BNT141 and BNT142 encode antibodies targeting cancer cells, leveraging optimized mRNA technology to overcome limitations of recombinant antibodies[74](index=74&type=chunk) [FixVac](index=12&type=section&id=FixVac) FixVac is BioNTech's off-the-shelf mRNA vaccine program, with BNT111 entering a Phase 2 trial and receiving FDA Fast Track designation, and BNT116 advancing into clinical development for NSCLC - In 2021, two FixVac programs, **BNT111** (for anti-PD1 refractory/relapsed melanoma) and **BNT113** (for HPV16+ PDL1+ head and neck cancer), entered Phase 2 trials[65](index=65&type=chunk) - BNT111 received **FDA Fast Track designation** and Orphan Drug Designation for the treatment of advanced melanoma[68](index=68&type=chunk) - The collaboration with Regeneron for **BNT116** was expanded, with a first-in-human clinical trial for advanced non-small cell lung cancer (NSCLC) expected to start in the second half of 2022[69](index=69&type=chunk) [Individualized Neoantigen Specific Immunotherapy (iNeST)](index=13&type=section&id=Individualized%20Neoantigen%20Specific%20Immunotherapy%20(iNeST)) iNeST is an individualized cancer immunotherapy developed with Genentech, with its lead candidate, autogene cevumeran, having initiated a Phase 2 trial for adjuvant colorectal cancer - **autogene cevumeran (BNT122)** is BioNTech's lead iNeST product candidate, developed in collaboration with Genentech[71](index=71&type=chunk) - A randomized Phase 2 trial of autogene cevumeran has been initiated in the adjuvant treatment of ctDNA-positive, surgically resected Stage II (high-risk)/Stage III colorectal cancer[72](index=72&type=chunk) - A data update from the randomized Phase 2 trial of autogene cevumeran combined with pembrolizumab in 1L metastatic melanoma is expected in the **second half of 2022**[73](index=73&type=chunk) [RiboMabs](index=13&type=section&id=RiboMabs) RiboMabs are BioNTech's mRNA antibody programs, with BNT141 entering a Phase 1/2 trial for Claudin-18.2 positive tumors and BNT142 planned for a Phase 1 trial in the first half of 2022 - **BNT141**, which encodes a secreted antibody targeting Claudin-18.2, initiated a Phase 1/2 clinical trial in January 2022 for patients with Claudin-18.2 positive tumors[76](index=76&type=chunk)[77](index=77&type=chunk) - **BNT142**, which encodes a bispecific antibody targeting CD3 and Claudin-6, is planned to start a Phase 1 clinical trial in the **first half of 2022**[78](index=78&type=chunk) [Antibodies](index=14&type=section&id=Antibodies) BioNTech's antibody program, in collaboration with Genmab, includes next-generation checkpoint immunomodulators, with BNT311/GEN1046 having initiated a Phase 2 trial for NSCLC - BioNTech is collaborating with Genmab to develop two bispecific antibody checkpoint immunomodulators, **BNT311** and **BNT312**[79](index=79&type=chunk) - A Phase 2 trial of **BNT311/GEN1046** in relapsed/refractory metastatic NSCLC was initiated in December 2021, with 10 expansion cohorts ongoing[80](index=80&type=chunk)[81](index=81&type=chunk) - The Phase 1/2 trial of **BNT312/GEN1042** in solid tumors is ongoing, with expansion cohorts in melanoma, NSCLC, pancreatic cancer, and head and neck cancer currently enrolling[81](index=81&type=chunk) [Cell Therapies](index=15&type=section&id=Cell%20Therapies) BioNTech's cell therapy program is led by the CAR-T candidate BNT211, which targets CLDN6+ solid tumors and has shown a tolerable safety profile and preliminary clinical activity in a Phase 1/2 trial - **BNT211** is BioNTech's first CAR-T product candidate, targeting CLDN6+ solid tumors and combined with a CAR-T cell amplifying RNA vaccine (CARVac)[83](index=83&type=chunk) - Phase 1/2 trial data for BNT211 showed a **tolerable safety profile** and preliminary clinical activity, with 9 of 10 evaluable patients showing initial disease control, including 4 partial responses and 5 with stable disease[85](index=85&type=chunk)[86](index=86&type=chunk) - A further data update from the Phase 1/2 trial is expected in the **second half of 2022**[86](index=86&type=chunk) [Corporate & ESG Updates](index=15&type=section&id=Corporate%20%26%20ESG%20Updates) [Corporate Updates](index=15&type=section&id=Corporate%20Updates) BioNTech announced several corporate updates in early 2022, including collaborations with InstaDeep, Crescendo Biologics, and Medigene AG to enhance its R&D and digital transformation capabilities - A collaboration with InstaDeep designed, developed, and successfully tested an **AI-based Early Warning System (EWS)** for real-time analysis and prediction of high-risk SARS-CoV-2 variants[87](index=87&type=chunk)[89](index=89&type=chunk) - A multi-target discovery collaboration was established with Crescendo Biologics Ltd to develop novel immunotherapies for cancer and other diseases[90](index=90&type=chunk) - An asset purchase and option agreement and a multi-target research collaboration were signed with Medigene AG to develop novel T cell receptor (TCR) immunotherapies, with BioNTech holding exclusive worldwide development and commercialization rights[91](index=91&type=chunk) [Environmental, Social, and Governance (ESG) Overview](index=16&type=section&id=Environmental%2C%20Social%2C%20and%20Governance%20(ESG)%20Overview) The company is committed to social responsibility and environmental protection, with plans for mRNA manufacturing in Africa, modular "BioNTainer" solutions, and science-based emissions reduction targets - BioNTech plans to begin construction of advanced mRNA manufacturing sites in **Africa and Asia** in 2022 to establish sustainable local supply[93](index=93&type=chunk) - The **"BioNTainer"** turnkey manufacturing solution was introduced, a modular unit for scalable mRNA vaccine production, with the first BioNTainer expected to arrive in Africa in the second half of 2022[94](index=94&type=chunk) - The Management Board's variable compensation is linked to the achievement of ESG goals, including maintaining a **"Prime" rating** from the ISS ESG rating agency[95](index=95&type=chunk)[96](index=96&type=chunk) - Climate protection targets aligned with the Science Based Targets initiative (SBTi) were set: an absolute reduction of **42% in Scope 1 and Scope 2 GHG emissions** by 2030 (from a 2021 baseline)[97](index=97&type=chunk) - The company has committed to supplying over **2 billion doses** of its COVID-19 vaccine to low- and middle-income countries by the end of 2022[98](index=98&type=chunk) [Upcoming Investor and Analyst Events](index=17&type=section&id=Upcoming%20Investor%20and%20Analyst%20Events) BioNTech has scheduled its Annual General Meeting for June 1, 2022, and a Capital Markets Day for June 29, 2022 - The **Annual General Meeting** will be held on June 1, 2022[99](index=99&type=chunk) - The company will host a **Capital Markets Day** for analysts and investors on June 29, 2022[99](index=99&type=chunk) [About BioNTech](index=17&type=section&id=About%20BioNTech) BioNTech is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, leveraging a broad suite of platforms to develop a diverse pipeline of product candidates - BioNTech is a next-generation immunotherapy company dedicated to novel therapies for cancer and other serious diseases[100](index=100&type=chunk) - The company utilizes computational discovery and therapeutic drug platforms to rapidly develop novel biopharmaceuticals[100](index=100&type=chunk) - Its broad oncology pipeline includes individualized and off-the-shelf mRNA therapies, chimeric antigen receptor T cells, bispecific checkpoint immunomodulators, targeted cancer antibodies, and small molecules[100](index=100&type=chunk) - Based on its deep expertise in mRNA vaccine development and in-house manufacturing, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for infectious diseases[100](index=100&type=chunk) - The company has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, Regeneron, Genevant, Fosun Pharma, and Pfizer[100](index=100&type=chunk) [Forward-Looking Statements](index=17&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding BioNTech's expectations for revenues, R&D, clinical trials, and other factors, which are subject to significant risks and uncertainties detailed in its SEC filings - Forward-looking statements relate to BioNTech's expected revenues and net profit, COVID-19 vaccine sales, market competition, R&D programs, clinical trials, regulatory approvals, collaborations, the impact of the COVID-19 pandemic, manufacturing capacity, capital expenditures, and income taxes[101](index=101&type=chunk)[103](index=103&type=chunk) - These statements are not promises or guarantees and are subject to known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from expectations[105](index=105&type=chunk) - Investors should consult the "Risk Factors" section in the company's Annual Report on Form 20-F filed with the SEC[105](index=105&type=chunk) [Financial Statements](index=20&type=section&id=Financial%20Statements) [Consolidated Statements of Profit or Loss](index=20&type=section&id=Consolidated%20Statements%20of%20Profit%20or%20Loss) BioNTech's consolidated statements of profit or loss show substantial growth in revenues and net profit for Q4 and full-year 2021, driven by commercial income, alongside increased operating and tax expenses Summary Consolidated Statements of Profit or Loss (million EUR) | Metric | Q4 2021 | Q4 2020 | Full Year 2021 | Full Year 2020 | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | 5,532.5 | 345.4 | 18,976.7 | 482.3 | | Cost of Sales | (583.2) | (41.0) | (2,911.5) | (59.3) | | R&D Expenses | (271.5) | (257.0) | (949.2) | (645.0) | | Selling and Marketing Expenses | (17.9) | (6.7) | (50.4) | (14.5) | | G&A Expenses | (130.9) | (35.9) | (285.8) | (94.0) | | Operating Profit/(Loss) | 4,699.7 | 244.2 | 15,283.8 | (82.4) | | Income Taxes | (1,547.7) | 161.3 | (4,753.9) | 161.0 | | Profit/(Loss) for the Period | 3,166.2 | 366.9 | 10,292.5 | 15.2 | | Diluted EPS (€) | 12.18 | 1.43 | 39.63 | 0.06 | [Consolidated Statements of Financial Position](index=21&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) The company's total assets grew significantly as of December 31, 2021, driven by increased trade receivables and cash, with a corresponding rise in total equity reflecting strong profitability Summary Consolidated Statements of Financial Position (million EUR) | Metric | As of Dec 31, 2021 | As of Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Total Non-Current Assets | 758.5 | 651.7 | | Total Current Assets | 15,072.3 | 1,666.9 | | **Total Assets** | **15,830.8** | **2,318.6** | | **Equity and Liabilities** | | | | Total Equity | 11,893.7 | 1,371.8 | | Total Non-Current Liabilities | 455.5 | 340.8 | | Total Current Liabilities | 3,481.6 | 606.0 | | **Total Liabilities** | **3,937.1** | **946.8** | | **Total Equity and Liabilities** | **15,830.8** | **2,318.6** | - Trade and other receivables within current assets increased from **€165.5 million** in 2020 to **€12.3817 billion** in 2021[109](index=109&type=chunk) - Other financial liabilities within current liabilities increased from **€74.1 million** in 2020 to **€1.1904 billion** in 2021, and income tax liabilities grew from nil to **€1.5689 billion**[109](index=109&type=chunk) [Consolidated Statements of Cash Flows](index=23&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) BioNTech's consolidated cash flow statements for 2021 show net cash generated from operating activities of €889.7 million, with significant cash used in investing activities and a net increase in cash for the year Summary Consolidated Statements of Cash Flows (million EUR) | Metric | Q4 2021 | Q4 2020 | Full Year 2021 | Full Year 2020 | | :--- | :--- | :--- | :--- | :--- | | Net cash flows from operating activities | (199.7) | 249.2 | 889.7 | (13.5) | | Net cash flows from investing activities | (466.8) | (99.8) | (566.1) | (144.8) | | Net cash flows from financing activities | (48.9) | 116.3 | 94.2 | 894.7 | | Net increase/(decrease) in cash | (715.4) | 265.7 | 417.8 | 736.4 | | Cash and cash equivalents at end of period | 1,692.7 | 1,210.2 | 1,692.7 | 1,210.2 | - For the full year 2021, the decrease/(increase) in trade and other receivables, contract assets and other assets was **-€11.8081 billion**, significantly impacting operating cash flow[111](index=111&type=chunk) - For the full year 2021, income taxes (received/(paid), net) amounted to **-€3.4579 billion**[111](index=111&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...

BioNTech SE (NASDAQ:BNTX) JPMorgan 40th Annual Healthcare Conference Call January 11, 2022 9:45 AM ET Company Participants Ugur Sahin - Co-Founder & Chief Executive Officer Jens Holstein - Chief Financial Officer Sean Marett - Chief Business & Commercial Officer Ozlem Tureci - Chief Medical Officer Ryan Richardson - Chief Strategy Officer Conference Call Participants Cory Kasimov - JPMorgan Chase & Co. Cory Kasimov Great. Good morning or good afternoon from the 40th Annual JPMorgan Healthcare Conference. My ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...