SUSTAINABILITY REPORT
BioNTech | 2 |
PROF. UGUR SAHIN, M. D. | JENS HOLSTEIN | SEAN MARETT | SIERK POETTING, PH.D. |
Chief Executive Officer and Founder | Chief Financial Officer | Chief Business and Chief Commercial Officer | Chief Operating Officer |
RYAN RICHARDSON | JAMES RYAN , PH.D. | PROF. ÖZLEM TÜRECI, M. D. |
Chief Strategy Officer | Chief Legal Officer | Chief Medical Officer and Founder |
BioNTech Sustainability Report 2023
BioNTech | 3 |
FIGHTING AGAINST COVID-19 INFECTIOUS DISEASE PROGRAMS ONCOLOGY PIPELINE
~ 460 | 7 | programs | 20 + | |
clinical | ||||
million total vaccine | clinical | |||
doses distributed1 | 3 first-in-human trials started | programs in | ||
Shingles 2 | Tuber- | Mpox 4 | 30 ongoing | |
culosis 3 | ||||
clinical trials
SOCIAL | ENVIRONMENTAL |
~ 6,300 employees 5 | SBTi-validated Scope 1, 2 and 3 |
from over 80 nations | targets in 2024 |
A 21ST CENTURY IMMUNOTHERAPY POWERHOUSE
Fully integrated biotechnology company
Multi-platform strategy
Diversified product pipeline
Based on global social responsibility
OUR VALUES
united passionate innovative
1 January to December 3, 2023. | 2 Partnered with Pfizer. | 3 In collaboration with the Bill & Melinda Gates Foundation. | 4 Partnered with the Coalition for Epidemic Preparedness Innovations (CEPI). | 5 Including 328 InstaDeep employees as of December 31, 2023.
BioNTech Sustainability Report 2023
CONTENTS
1.0 | About BioNTech | 6 |
2.0 | Our Responsibility | 14 |
3.0 | Corporate Citizenship | 22 |
4.0 | Responsible Governance | 29 |
5.0 | Environmental and Climate Protection | 47 |
6.0 | Attractive Employer | 60 |
7.0 | ESG Ratings and Memberships | 75 |
8.0 | Appendix and Data | 79 |
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4
OUR PURPOSE
BioNTech was founded in Mainz, Germany, in 2008 with the
understandingthat each cancer patient's tumor is unique and the vision that each patient's treatment should be individualized. To turn this idea into reality, we have combined innovative research with cutting-edge technologies.
Our objective is to develop breakthrough therapies against cancer, infectious diseases and other serious diseases.
As a next-generation immunotherapy company, we are working to clinically prove the benefits of our treatment approach. Our COVID-19 vaccine is an important milestone. We are continuously expanding our collaborations, our team and our own manufacturing capabilities with the aim of providing individualized treatments to patients around the world.
We are accelerating the development of our diversified pipeline of next-generation immunotherapies, aspiring to improve the health of people worldwide by harnessing the full potential of the immune system. In addition to cancer, infectious diseases and other serious diseases, this includes autoimmune diseases and allergies and regenerative medicine.
BioNTech Sustainability Report 2023
Dear Reader,
Since its founding, BioNTech has been driven by a fundamental motivation to act responsibly towards patients and society. This remains true today and will continue to be our driving force in the future.
This motivation shapes our vision, mission, culture, and ways of work- ing. Our goal is to translate science into survival by developing new immunotherapies and vaccines to improve the health of people world- wide. We believe this gives us wide corporate responsibility and an ambition to do everything in a sustainable way.
Our commitment to sustainability extends to our focus on improving and reinforcing healthy processes and systems surrounding our people, culture, and organization to achieve our business objectives. With a focus on corporate responsibility and sustainability, this report outlines our developments in this area in 2023.
We have continued to develop responsible corporate governance practices across our business, which we believe will further strengthen our resilience in an increasingly competitive environment. Our progress in respecting human rights is worth highlighting. We see the intro-
5
Over the last 15 years, we have steadily expanded our pipeline, which now includes several platform technologies and candidates targeting cancer, infectious, and other serious diseases. The first-ever approved mRNA vaccine - the Pfizer-BioNTechCOVID-19 Vaccine, or COMIR- NATY - was created in our labs.
The progress of our COMIRNATY vaccine business and the advancement of our innovative oncology pipeline are key components of our sustainability efforts and reflect our unwavering commitment to the United Nations Sustainable Development Goals (SDGs). We aim to leverage the resources and skills of our new Global Health Office (GHO) to support the advancement and expansion of our infectious disease programs and further contribute to equitable access to mRNA medicines. The GHO provides a public health perspective to support the end-to-end development of innovative medicines that aim to address major unmet public health needs, particularly those affecting populations in low- and middle-income countries and those with an inequity or pandemic preparedness dimension.
duction of respective regulations in Germany and worldwide as an opportunity to further enhance our due diligence processes in this regard to improve the lives of affected people regarding basic human rights.
Protecting our climate remains a key objective. Our ambitious science- based climate targets were validated by the Science Based Target Initiative (SBTi) in 2024. With a dedicated global decarbonization team, appropriate investments, and consistent individual measures, we believe we are well-positioned to achieve our climate targets by 2030.
The Management Board would like to thank everyone who has supported us in the past year and continues to do so. We are grateful to our passionate employees, whose hard work is key to our success. We also appreciate our business partners' trust and collaboration that help us achieve our goals and make a positive impact on the world. Lastly, we want to thank our investors, shareholders, and the Supervisory Board for their ongoing support.GRI 2-22
Prof. Ugur Sahin, M.D.
Chief Executive Officer
and Co-Founder
Prof. Özlem Türeci, M.D. Chief Medical Officer and Co-Founder
Sean Marett
Chief Business and Chief Commercial Officer
Sierk Poetting, Ph.D.
Chief Operating Officer
Jens Holstein
Chief Financial Officer
Ryan Richardson
Chief Strategy Officer
James Ryan, Ph.D.
Chief Legal Officer
BioNTech Sustainability Report 2023
1.0
Developing a
Next-Generation
Immunotherapy
6
1.1 | Business Overview | 7 |
1.2 | 2023 Financial Results | 10 |
1.3 | Economic Contributions | 10 |
1.4 | Group Management CSR | 10 |
Completing construction of BioNTech's | 40 + |
first proprietary plasmid DNA manufacturing | |
facility in Marburg, Germany | |
clinical trials |
Company
FOR A BETTER FUTURE:
We are always aspiring to deepen our understanding of the human immune system.
3.8 billion
total revenues
in 2023 financial year in euros
10 phase 2 or phase 3 clinical trials in oncology
Acquisition of InstaDeep, enabling BioNTech to leverage artificial intelligence and machine learning technologies across its therapeutic platforms and operations
1.0 BioNTech | BioNTech Sustainability Report 2023 |
1.0 ABOUT BioNTech | 7 |
1.1 BUSINESS OVERVIEW
BioNTech is a global next-generation immunotherapy company pioneering novel medicines against cancer, infectious diseases and other serious diseases. Since its founding in 2008, the Company has focused on harnessing the power of the immune system to address human diseases with unmet medical needs and major global health burdens. BioNTech's fully integrated model combines decades of research in immunology with a multi-technology innovation engine, GMP manufacturing,
translational drug discovery, clinical development, commercial capabili- ties, computational medicine, data science and artificial intelligence (AI) and machine learning (ML) capabilities to discover, develop and commercialize its marketed products and product candidates.
BioNTech has built a broad toolkit across multiple technology platforms, including a diverse range of potentially first-in-class therapeutic approaches. This includes investigational messenger ribonucleic acid, or mRNA vaccines, protein-based therapeutics (including targeted
antibodies such as monoclonal, bispecific and antibody-drug conju- gates, or ADCs), cell therapies and small molecules.
The Company expects each platform to yield a pipeline of product
candidatesfor further development. BioNTech's multi-technology combination of platforms and product candidates positions the Company as a pioneer in the field of individualized, patient-centric therapeutic approaches in oncology and infectious diseases. BioNTech aims to expand this status into other disease areas in the future.
Advancing Our Vision: A Once-in-a-Generation Opportunity to Transform Medicine
We aim to be a multi-product global biotechnology leader, working to address the world's most pressing health challenges with pioneering, disruptive technologies delivered at scale.
Maintain and deepen COVID-19 vaccine leadership
Globally marketed COVID-19 vaccine franchise1
Oncology | Infectious diseases |
20 + programs in 30 clinical trials | 7 programs in |
10 Phase 2 or Phase 3 trials | 10 + clinical trials |
Launch next-generation and combination COVID-19 vaccines
Launch multiple oncology products from 2026 onwards
Approved products across oncology and infectious disease portfolio
Potential new disease areas
Innovation engine producing multiple INDs | |
Initiating additional potentially registrational trials | per year |
DRIVING TRANSFORMATION TODAY | MID-TERM GOALS 2025 - 2029 |
1 Partnered with Pfizer; IND = Investigational New Drug.
Cardiovascular | Neurodegener- | Autoimmune |
diseases | ative diseases | diseases |
LONG-TERM VISION 2030
1.0 BioNTech | 1.1 Business Overview | BioNTech Sustainability Report 2023 |
In oncology, BioNTech endeavors to address the continuum of cancer patients. The root causes of cancer treatment failure are cancer heterogeneity and interindividual variability. Driven by random sequential muta- tions, every patient's cancer is different and within one patient's tumor, every cell is different. Addressing these two challenges is the core of BioNTech's strategy. To augment anti-tumor activity and to counteract resistance mechanisms, the Company seeks to combine compounds with non-overlapping, synergistic mechanisms of action.
In infectious disease, BioNTech's product strategy is rooted in global social responsibility and the Company's goal of contributing to equitable access to medicine.
BioNTech's approach has generated a robust and diversified product pipeline across a range of technologies in oncology and infectious
disease, and has led to the approval of its first marketed product,
COMIRNATY.
BioNTech's key objectives include building a sustainable respiratory infectious disease vaccine business based on the BioNTech-Pfizer COMIRNATY franchise and developing an innovative precision medicine pipeline targeting multiple product approvals in the coming years. BioNTech is well-positioned to pursue its objectives by leveraging a technology -agnostic approach rooted in decades of research in immunology coupled with expertise in emerging mRNA technologies. The Company's vision is to establish a multi-product company based on its pioneering technologies and science to contribute to improving the health of people worldwide.
Progress on Strategic Objectives in 2023
In 2023, BioNTech executed across four key strategic pillars to strengthen its technology platforms, digital capabilities and infrastructure through strategic investments, acquisitions, licensing agreements and public- private partnerships impacting patients, shareholders and other stake- holders.
1 Includes InstaDeep.
1. Leadership in COVID-19 Vaccine Development
BioNTech continued to build its COVID-19 vaccine franchise and maintained market leadership in multiple key geographies. In 2023, BioNTech and Pfizer distributed over 460 million total COMIRNATY doses, of which over 190 million doses were BioNTech's Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. BioNTech and Pfizer introduced single- dose vials and never-frozen syringes in the United States.
2. Healthcare and Social Responsibility
BioNTech advanced its goal of contributing to equitable access to medicine around the globe, with over 30 % of COMIRNATY doses delivered to low- and middle-income countries in 2023 in line with demand. The Company continues to work with non-governmental organizations (NGOs), institutes and governments to plan for equitable access to novel medicines, especially in low and middle-income countries and regions.
BioNTech is progressing the development of mRNA vaccine candidates for infectious diseases with high medical need, including vaccine candidates against tuberculosis, malaria, and HIV, as well as against infectious diseases with pandemic potential, such as mpox. In December 2023, BioNTech reached an important milestone towards the establishment of mRNA vaccine manufacturing capacities in Africa with the inauguration of its facility in Kigali, Rwanda.
3. Innovative and Diversified Pipeline
BioNTech continued to develop its innovative oncology and infectious disease pipeline. Today, BioNTech's pipeline consists of over 20 programs in oncology and seven programs in infectious disease being evaluated in over 40 clinical trials, including eight Phase 2 and two Phase 3 clinical trials in oncology. In 2023, BioNTech and its partners reported data across their portfolio at multiple medical meetings and published manuscripts in peer-reviewed journals.
In oncology, BioNTech started seven clinical trials and in-licensed six clinical assets throughout the year. Most importantly, BioNTech brought several assets into mid- and late-stage development, namely Phase 2 and Phase 3 clinical trials, across a range of technologies, in particular, ADCs and mRNA vaccines.
BioNTech expanded its technology base to include ADCs by initiating | 8 | |
new collaborations with DualityBio and MediLink Therapeutics. BioNTech | ||
believes ADCs have the potential to supplement or replace high toxic | ||
chemotherapy regimens as a new combination backbone of cancer | ||
treatment. BioNTech's growing ADC pipeline includes ADCs directed | ||
against four distinct targets and is of interest for a broad range of cancer | ||
types. BioNTech's collaborations with OncoC4 and Biotheus comple- | ||
ment its toolkit of technologies with next-generationimmuno-oncology | ||
antibodies that offer unique mechanism of action and have augmented | ||
BioNTech's oncology pipeline with mid- to late-stage clinical programs. | ||
In infectious diseases, BioNTech started three first-in-human Phase 1 | ||
clinical trials leveraging its proprietary mRNA prophylactic vaccine tech- | ||
nology, including candidates being evaluated against shingles, tuber | ||
culosis, and mpox. | ||
Over the next year, BioNTech aims to advance additional product candi- | ||
dates towards late-stage development and expects to have ten or more | ||
potentially registrational trials running by the end of 2024. The Company | ||
expects to continue building its pipeline towards its planned first oncology | ||
launch in 2026. BioNTech aims to have ten indication approvals by 2030. | ||
4. Innovation at Scale | ||
BioNTech is building and scaling biotech innovation with the aim of | ||
becoming a patient-centric,AI-driven,multi-product company. In 2023, | ||
BioNTech attracted top talent, including clinical and regulatory experts, | ||
to advance the development of its pipeline. The Company expanded its | ||
team to roughly 6,300 employees 1 globally by welcoming more than | ||
1,600 new hires. BioNTech's diverse workforce represents more than | ||
80 nations, and BioNTech has subsidiaries in countries across five | ||
continents. | ||
In 2023, BioNTech expanded its organization in Asia, Africa, North | ||
America, | Australia and Europe. BioNTech increased its overall research | |
and development and production capabilities, including completing | ||
construction | of its first proprietary plasmid DNA manufacturing facility in | |
Marburg, Germany. BioNTech also established a corporate office in | ||
Shanghai, China. |
1.0 BioNTech | 1.1 Business Overview | BioNTech Sustainability Report 2023 |
In 2023, BioNTech entered into multiple complementary agreements and collaborations, including:
-
The completion of the acquisition of its long-time strategic collabora- tion partner, InstaDeep Ltd, or InstaDeep, which enables BioNTech to leverage AI and ML technologies across the Company's therapeutic platforms and operations. With the acquisition of InstaDeep, BioNTech has added industry-leading AI and ML capabilities and approximately 290 highly skilled professionals to its organization. InstaDeep operates
as a London -based subsidiary. - A strategic collaboration with the Government of the United Kingdom, or the U.K., to provide up to 10,000 patients with personalized mRNA cancer immunotherapies by 2030, either in clinical trials or as autho- rized treatments. BioNTech plans to invest in a research and develop- ment hub in Cambridge, U.K., with an expected capacity of more than 70 highly skilled scientists.
- A multi-year agreement with Australia's state of Victoria to set up and operate clinical-scale mRNA vaccine manufacturing through the Company's BioNTainer units and establish an mRNA Innovation Cen- ter in Melbourne.
Post year-end, in February 2024, in line with BioNTech's goal of scaling up innovation, BioNTech and Autolus Therapeutics plc, or Autolus, announced a strategic collaboration aimed at advancing both compa- nies' autologous CAR-T programs towards commercialization, pending regulatory authorizations. As part of the strategic collaboration, BioNTech has the option to access Autolus commercial and clinical site network and manufacturing capacities in the U.K. and commercial supply infrastructure in a cost-efficientset-up allowing for the accelerated development of BioNTech's product candidate BNT211.
In 2023, BioNTech strengthened its balance sheet through strong financial performance, ending the year with approximately USD 17.7 billion in total cash, cash equivalents and security investments. With a strong
financial position, leading COVID-19 vaccine franchise, and innovative oncology and infectious disease pipeline, BioNTech believes it is well positioned to continue executing on the Company's vision of pioneering novel medicines against cancer, infectious diseases, and other serious diseases.
Further detail on the collaborations, marketing rights, manufacturing oper- ations, and facilities, as well as a full commercial, clinical development and regulatory update on BioNTech's and Pfizer's COVID-19 vaccine, can be found in BioNTech's Annual Report on Form 20-F for the year ended December 31, 2023, which is available on BioNTech's website.GRI 2-6
Marketed Products: COMIRNATY,
BioNTech's COVID-19 Vaccine Program (BNT162)
BioNTech's commercial product, COMIRNATY, was the first-ever approved mRNA-based product, and, to the Company's knowledge, represents the fastest ever developed prophylactic vaccine from viral sampling to approval. As of December 2023, BioNTech's COVID-19 vaccine products have been authorized or approved for emergency or temporary use or granted marketing authorization in more than 180 countries and regions worldwide. BioNTech's efforts have resulted in more than 4.8 billion doses shipped globally.
Under BioNTech's collaboration with Pfizer, BioNTech is the Marketing Authorization Holder in the United States, the European Union, or E.U., the U.K., Canada and other countries. Additionally, BioNTech is the holder of emergency use authorizations, or EUAs, or equivalents in the United States (jointly with Pfizer) and other countries for the COVID-19 vaccine program. Pfizer has marketing and distribution rights worldwide apart from Greater China, Germany, and Türkiye. BioNTech has the marketing and distribution rights to COMIRNATY in Germany and Türkiye.
Under BioNTech's collaboration with Fosun Pharmaceutical Industrial Development, Co., Ltd, or Fosun Pharma, Fosun Pharma has marketing and distribution rights in Mainland China, Hong Kong Special Administrative Region, or SAR, Macau SAR and Taiwan.
Manufacturing and Distribution | 9 |
BioNTech and Pfizer continue to collaborate with governments and health ministries around the world to efficiently distribute COMIRNATY. BioNTech has developed a global COVID-19 vaccine supply chain and manufacturing network spanning four continents to meet the ongoing global demand of COMIRNATY.
In 2023, BioNTech began transitioning from an advanced purchase agreement framework to commercial market ordering in some geographies.
In May 2023, BioNTech and Pfizer announced an agreement with the European Commission, or the EC, to amend the previous COVID-19 Vaccine Purchase Agreement to deliver COVID-19 vaccines to the E.U. The amended agreement reflects BioNTech's and Pfizer's commitment to working collaboratively to help address ongoing public health needs, while respecting the principles of the original agreement. The agreement rephased delivery of doses annually through 2026. In addition, the
agreement includes an aggregate volume reduction, providing additional flexibility for E.U. Member States. The EC will maintain access to future adapted COVID-19 vaccines and the ability to donate doses, in alignment with the original agreement.
In October 2023, BioNTech and Pfizer announced an agreement between the Japanese government and Pfizer Japan Co., Ltd. to supply an additional 9 million doses of the Omicron XBB.1.5-adaptedCOVID-19 vaccine for the special vaccination program in Japan, which started in autumn 2023. The agreement followed an agreement between the Japanese government and Pfizer in July 2023 to supply 20 million doses and additional supplies as needed, and an agreement announced in Sep- tember 2023 to provide additional 10 million doses of the companies' Omicron XBB.1.5-adaptedCOVID-19 vaccine for the special vaccination program in Japan.
1.0 BioNTech | 1.1 Business Overview | BioNTech Sustainability Report 2023 |
Legal Structure
The Company was founded and incorporated on June 2, 2008 as Petersberg 91, V AG, a German stock corporation (Aktiengesellschaft). The Company changed its name to BioNTech AG on December 11, 2008. On March 8, 2019, the Company converted to a European stock corporation (Societas Europaea, or SE) under the laws of Germany and the European Union called BioNTech SE. BioNTech completed its initial public offering in October 2019. ADSs representing its ordinary shares are currently listed on the Nasdaq Global Select Market under the symbol "BNTX".
In this sustainability report, "BioNTech", the "Group", the "Company", "we", "us", and "our" refer to BioNTech SE and its subsidiaries, except where the context requires otherwise.
The full list of subsidiaries and parent companies, including an entity with significant influence over the Group, as well as comprehensive documentation on changes to the Group structure, are published in the Com- pany's Annual Report on Form 20-F for the 2023 financial year, which is
accessible on the website of BioNTech.GRI 2-1,2-2
Organizational Structure
Management
The Company has a dual management system. The Management Board, as the managing body, currently has seven members who are appointed and supervised by the Supervisory Board, which also approves major business decisions. The Supervisory Board is elected by the Annual General Meeting (AGM) and currently consists of six members. A more detailed overview of board practices is provided in Chapter 4.1 Managing Responsi-
ble Governance.
On May 3, 2023, BioNTech's Supervisory Board expanded the Compa- ny's Management Board by appointing James Ryan as Chief Legal Officer (CLO), effective as of September 1, 2023. As CLO, James Ryan heads up BioNTech's legal department and is responsible for developing
and leading the Company's corporate legal strategy to promote and
protect BioNTech's global operations. His current appointment to BioNTech's Management Board will end on August 30, 2027.
In 2023, the term of office of the Supervisory Board members Ulrich Wandschneider, Christoph Huber and Michael Motschmann, who were elected by the shareholders at the Annual General Meeting (AGM) on September 17, 2018, ended at the close of the Annual General Meeting on May 25, 2023. As part of the 2023 AGM, Ulrich Wandschneider and Michael Motschmann were re-elected as Supervisory Board members. In addition, Nicola Blackwood was appointed to BioNTech's Supervisory Board. She succeeded Christoph Huber, who left the Supervisory Board after reaching the applicable retirement age limit. Ulrich Wandschnei- der's, Nicola Blackwood's and Michael Motschmann's current appointments to BioNTech's Supervisory Board will end at the AGM in 2027.
Workforce
As of the December 31, 2023 reporting date, there were 5,964 employees (6,292 employees including InstaDeep), of which 3,166 were employed by BioNTech SE (December 31, 2022: 4,692, of which 2,304 were employed by BioNTech SE). The average number for the year was 5,640 employees (2022: 4,104).
1.2 2023 FINANCIAL RESULTS
In the 2023 financial year, BioNTech's total revenues were EUR 3.8 billion (2022: EUR 17.3 billion).
For more details on the Company's 2023 financial results, please refer to BioNTech's Annual Report 2023 on Form 20-F filed with the SEC on March 20, 2024. This report is available on the website of BioNTech and the website of the SEC.
1.3 ECONOMIC CONTRIBUTIONS | 10 |
BioNTech's financial results for the 2023 financial year, including its revenues and expenses for research and development, sales and marketing, and administration, are available in BioNTech's Annual Report 2023 on Form 20-F filed with the SEC on March 20, 2024. This report is available on the website of BioNTech and the website of the SEC.
Information describing BioNTech's community involvement can be found
in Chapter 3.0 Corporate Citizenship.GRI 201-1
1.4 GROUP MANAGEMENT CSR
CSR Governance
As a biotech company engaged in research and commercial manufac- turing, BioNTech bears responsibility for how it conducts its business and the impact its activities have on the wider economy, people and the environment.
The overall responsibility for managing such impacts within BioNTech's corporate social responsibility (CSR) lies with the Management Board. It receives support from the CSR Steering Board, which is responsible for the strategic, group-wide management of CSR and sustainability topics. The CSR Steering Board consists of BioNTech's Chief Medical Officer, Prof. Özlem Türeci, M.D., and Chief Operating Officer (COO), Sierk Poetting, Ph.D., as well as 16 senior executives representing departments that are critical from both a business and CSR perspective.GRI 2-12
BioNTech's CSR team is the driving force behind the systematic incorporation of CSR and sustainability into the organization, its processes, corporate culture and work practices. The CSR team reports directly to the COO and is responsible for preparing strategy proposals, analyses, decision papers and recommendations. It also coordinates the CSR issues for the BioNTech Group as a whole and ensures that the Group's operational development and sustainability reporting are addressed by cross-functional teams and work groups.
1.0 BioNTech | 1.1 Business Overview | 1.2 2023 Financial Results | 1.3 Economic Contributions | 1.4 Group Management CSR | BioNTech Sustainability Report 2023 |
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BioNTech SE published this content on 19 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 21 March 2024 04:10:07 UTC.