UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a‑16 OR 15d‑16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
FOR THE MONTH OF MARCH 2024
COMMISSION FILE NUMBER 001-39081
BioNTech SE
(Translation of registrant’s name into English)
(Translation of registrant’s name into English)
An der Goldgrube 12
D-55131 Mainz
Germany
+49 6131-9084-0
(Address of principal executive offices)
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20‑F or Form 40‑F: Form 20‑F ☒ Form 40‑F ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7): ☐
DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K
On March 20, 2024, BioNTech SE (the “Company”) issued a press release announcing its full year 2023 financial results and corporate update and details of a conference call to be held at 8:00 am EDT on March 20, 2024 to discuss the results. The press release and the conference call presentation are attached as Exhibits 99.1 and 99.2, respectively, and incorporated by reference herein.
The information contained in Exhibits 99.1 and 99.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, unless expressly set forth by specific reference in such a filing.
SIGNATURE
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| BioNTech SE | ||||||||
| By: | /s/ Jens Holstein | |||||||
| Name: Jens Holstein | ||||||||
| Title: Chief Financial Officer | ||||||||
Date: March 20, 2024
EXHIBIT INDEX
| Exhibit | Description of Exhibit | ||||
| 99.1 | |||||
| 99.2 | |||||
Exhibit 99.1
BioNTech Announces Fourth Quarter and Full Year 2023
Financial Results and Corporate Update
•Advanced oncology pipeline in mid- and late-stage with plans to have ten or more potentially registrational oncology trials running by the end of 2024
•Aiming for first oncology launch in 2026 and ten indication approvals by 2030 as part of BioNTech's strategy to develop combinatorial and synergistic therapeutic approaches
•Entered strategic collaborations with Biotheus, DualityBio, Medilink and OncoC4 to complement clinical oncology pipeline with innovative antibody-drug conjugate (ADC) and immuno-modulatory programs
•Annemarie Hanekamp appointed as Chief Commercial Officer effective July 1, 2024
•Delivered over 400 million COVID-19 vaccine doses worldwide in 2023, including successfully launched XBB.1.5 variant-adapted monovalent COVID-19 vaccine
•Progressed three infectious disease vaccine candidates into clinical evaluation, leveraging BioNTech's mRNA technology and expertise
•Fourth quarter and full year 2023 revenues of €1.5 billion and €3.8 billion, respectively
•Full year net profit of €0.9 billion and fully diluted earnings per share of €3.83 ($4.141)
•Strong financial position with €17.7 billion in cash, cash equivalents and security investments
•2024 revenue guidance of €2.5 billion to €3.1 billion
Conference call and webcast scheduled for March 20, 2024, at 8:00 a.m. ET (1:00 p.m. CET)
MAINZ, Germany, March 20, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today reported financial results for the three months and full year ended December 31, 2023, and provided an update on its corporate progress.
“2023 was another year of good performance for BioNTech. We have maintained our leading position in the COVID-19 vaccine market which lays the foundation for establishing a sustainable respiratory vaccines business. In oncology, we have strengthened our core competencies by entering into several partnerships and have made numerous clinical advances. Today, our oncology pipeline encompasses multiple candidates in mid- and late-stage clinical development, including investigational ADCs, mRNA vaccines and innovative immunotherapies,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “Our goal is to achieve product approvals in ten oncological indications by 2030 and with this improve the treatment options for patients around the globe.”
Financial Review for the Fourth Quarter and Full Year 2023 Financial Results
| in millions €, except per share data | Fourth Quarter 2023 | Fourth Quarter 2022 | Full Year 2023 | Full Year 2022 | ||||||||||
| Total Revenues | 1,479.0 | 4,278.3 | 3,819.0 | 17,310.6 | ||||||||||
| Net Profit | 457.9 | 2,278.7 | 930.3 | 9,434.4 | ||||||||||
Diluted Earnings per Share | 1.90 | 9.26 | 3.83 | 37.77 | ||||||||||
Total revenues reported were €1,479.0 million for the three months ended December 31, 2023, compared to €4,278.3 million for the comparative prior year period. For the year ended December 31, 2023, total revenues were €3,819.0 million, compared to €17,310.6 million for the comparative prior year period. Inventory write-downs by BioNTech's collaboration partner Pfizer, Inc. (“Pfizer”) reduced BioNTech's revenues by €291.3 million and €906.7 million for the three and twelve months ended December 31, 2023, respectively.
Cost of sales were €179.1 million for the three months ended December 31, 2023, compared to €183.5 million for the comparative prior year period. For the year ended December 31, 2023, cost of
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sales were €599.8 million, compared to €2,995.0 million for the comparative prior year period. The change was mainly caused by the decrease in COVID-19 vaccine sales.
Research and development (R&D) expenses were €577.8 million for the three months ended December 31, 2023, compared to €509.8 million for the comparative prior year period. For the year ended December 31, 2023, research and development expenses were €1,783.1 million, compared to €1,537.0 million for the comparative prior year period. R&D expenses are mainly influenced by progressing clinical studies for pipeline candidates as well as by our newly acquired product candidates and the development of variant-adapted COVID-19 vaccines. The increase was further driven by an increase in wages, benefits and social security expenses resulting from an increase in headcount.
General and administrative (G&A) expenses reached €124.3 million for the three months ended December 31, 2023, compared to €119.9 million for the comparative prior year period. For the year ended December 31, 2023, G&A expenses were €495.0 million, compared to €481.7 million for the comparative prior year period. G&A expenses were mainly influenced by increased expenses for IT services as well as by wages, benefits and social security expenses resulting from an increase in headcount.
Income taxes were accrued in an amount of €205.3 million for the three months ended December 31, 2023, compared to €893.9 million accrued for the comparative prior year period. For the year ended December 31, 2023, income taxes were accrued with an amount of €255.8 million, compared to €3,519.7 million accrued for the comparative prior year period. The derived annual effective income tax rate for the year ended December 31, 2023, was 21.6%.
Net profit was €457.9 million for the three months ended December 31, 2023, compared to €2,278.7 million for the comparative prior year period. For the year ended December 31, 2023, net profit was €930.3 million, compared to €9,434.4 million net profit for the comparative prior year period.
Cash and cash equivalents as well as security investments2 as of December 31, 2023, reached €17,653.4 million, comprising €11,663.7 million cash and cash equivalents and €5,989.0 million security investments, respectively.
Diluted earnings per share was €1.90 for the three months ended December 31, 2023, compared to diluted earnings per share of €9.26 for the comparative prior year period. For the year ended December 31, 2023, diluted earnings per share were €3.83, compared to €37.77 diluted earnings per share for the comparative prior year period.
Shares outstanding as of December 31, 2023, were 237,725,735, excluding 10,826,465 shares held in treasury.
In March 2023, the Management Board and Supervisory Board authorized the 2023 share repurchase program, under which BioNTech was permitted to purchase ADSs, each representing one ordinary share, with a value of up to $0.5 billion, which started June 2, 2023, and concluded on September 18, 2023. During the three months ended December 31, 2023, 114,513 ADSs were repurchased under the share repurchase program at an average price of $112.22 (€105.07), for total consideration of $12.9 million (€12.0 million). For the year ended December 31, 2023, a total of 4,646,965 ADSs were repurchased related to the 2023 program at an average price of $107.58 (€98.24), for total consideration of $0.5 billion (€456.5 million).
“In 2023, we strengthened our financial position while concurrently progressing our clinical pipeline of immunotherapies and executing acquisitions and collaborations. Looking ahead to 2024, we will maintain a prudent capital allocation strategy as we invest and execute in our maturing pipeline and prepare for our first potential oncology launches,” said Jens Holstein, CFO of BioNTech. “Our COVID-19 vaccine franchise is expected to remain an important cash contributor in 2024. We believe
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our solid financial position will enable us to push forward with our long-term strategy to develop novel therapies against cancer, infectious and other severe diseases thereby generating added value for patients, society, investors and the Company.”
Outlook for the 2024 Financial Year
The Company's outlook contains the following components:
Total revenues for the 2024 financial year | €2.5 billion - €3.1 billion | ||||
BioNTech expects group revenue for the full 2024 financial year to be in the range of €2.5 - €3.1 billion. The range reflects certain assumptions, including, but not limited to, expectations regarding: the timing and grant of regulatory approvals and recommendations, COVID-19 vaccine uptake and price levels, inventory write-downs by BioNTech's collaboration partner Pfizer that would negatively influence the Company's revenues, seasonal variations in SARS-CoV-2 circulation and vaccination uptake which are expected to lead to demand peaks in the autumn and winter compared to other seasons, revenues from a pandemic preparedness contract with the German government as well as revenues from BioNTech Group service businesses, namely InstaDeep, JPT Peptide Technologies GmbH and in Idar-Oberstein at BioNTech Innovative Manufacturing Services GmbH. Generally, the Company continues to remain largely dependent on revenues generated in its collaboration partner’s territories in 2024.
Planned 2024 Financial Year Expenses and Capex3:
R&D expenses4 | €2.4 billion - €2.6 billion | ||||
SG&A expenses5 | €700 million - €800 million | ||||
| Capital expenditures for operating activities | €400 million - €500 million | ||||
BioNTech expects to continue to focus investments on R&D and scaling the business for commercial readiness in oncology, while continuing to be cost disciplined. Strategic capital allocation will continue to be an important driver of the Company's trajectory. As part of BioNTech's strategy, the Company may continue to evaluate appropriate corporate development opportunities with the aim of driving sustainable long-term growth and create future value.
The full audited consolidated financial statements as of and for the year ended December 31, 2023, can be found in BioNTech’s Annual Report on Form 20-F for the period ended December 31, 2023, filed today with the United States Securities and Exchange Commission (“SEC”) and available at https://www.sec.gov/ (the “Annual Report”).
Endnotes
1 Calculated applying the average foreign exchange rate for the year ended December 31, 2023, as published by the German Central Bank (Deutsche Bundesbank).
2 The contractual settlement of the gross profit share has a temporal offset of more than one calendar quarter. As Pfizer’s financial quarter for subsidiaries outside the United States differs from BioNTech's, it creates an additional time lag between the recognition of revenues and the payment receipt.
3 Numbers reflect current base case projections and are calculated based on constant currency rates, and exclude external risks that are not yet known and/or quantifiable, including, but not limited to, the effects of ongoing and/or future legal disputes or related activity.
4 Numbers include effects identified from additional collaborations or potential M&A transactions to the extent disclosed and are subject to update due to future developments.
5 Anticipated expenses related to external legal advice in connection with certain legal litigations are not reflected in SG&A but in other operating expenses. Guidance does not include and may be impacted by potential
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payments resulting from the outcomes of ongoing or future legal disputes or related activity, such as judgments or settlements.
Operational Review of the Fourth Quarter 2023, Key Post Period-End Events and 2024 Outlook
Omicron XBB.1.5-adapted Monovalent COVID-19 Vaccine (COMIRNATY®)
•BioNTech and Pfizer developed, manufactured and delivered their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, which has received multiple regulatory approvals, including full approvals, authorizations for emergency or temporary use, or marketing authorizations in more than 40 countries and regions. In 2023, BioNTech and Pfizer delivered more than 400 million COVID-19 vaccine doses worldwide.
COVID-19 – Influenza Combination Vaccine Program
BNT162b2 + BNT161 is an mRNA-based combination vaccine program against COVID-19 and influenza being developed in collaboration with Pfizer.
•Topline data from the Phase 1/2 trial (NCT05596734) demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains and that the safety profile of the candidates was consistent with that of the companies’ COVID-19 vaccine. A Phase 3 clinical trial (NCT06178991) was initiated in December 2023.
Select Oncology Pipeline Highlights
BioNTech's vision for oncology is to bring novel therapies to patients and address the continuum of cancer treatment, from early to late lines. Addressing root causes of cancer treatment failure such as cancer heterogeneity and interindividual variability is the core of its strategy. To augment anti-tumor activity and to counteract resistance mechanisms, BioNTech seeks to combine compounds with non-overlapping, synergistic mechanisms of action.
In 2023, the Company’s pipeline continued to mature, with various programs advancing towards later stages of development. BioNTech’s oncology pipeline currently contains 10 ongoing Phase 2 and 3 trials. In 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.
Antibody-Drug Conjugate (ADC) Programs
BNT323/DB-1303 is an ADC candidate targeting Human Epidermal Growth Factor 2 (HER2) that is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”).
•An ongoing randomized, multi-center, open-label Phase 3 clinical trial (NCT06018337) is recruiting to evaluate BNT323/DB1303 versus the investigator's choice of chemotherapy in advanced or metastatic Hormone Receptor (HR)+, HER2-low breast cancer subjects whose disease has progressed on at least two lines of prior endocrine therapy or within six months of first-line endocrine therapy + cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy without prior chemotherapy. The first patient was dosed in January 2024 and the trial aims to enroll 532 patients.
•A potentially registrational single-arm trial enrolling HER2-expressing (immunohistochemistry score (“IHC”) 3+, 2+, 1+ or in situ hybridization (“ISH”)-positivet) patients with endometrial carcinoma is ongoing and plans to enroIl 140 patients.
•In December 2023, the U.S. Food and Drug Administration (“FDA”) granted Breakthrough Therapy designation for BNT323/DB-1303 for the potential treatment of advanced endometrial cancer in patients whose disease progressed on or after treatment with immune-checkpoint inhibitors.
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•First-in-human data from the ongoing Phase 1/2 trial (NCT05150691) were presented at medical conferences in 2023, indicating a manageable safety profile and anti-tumor activity in patients with heavily pretreated HER2-expressing solid tumors, including breast and endometrial cancer. Data from this trial informed the decision to further evaluate this candidate in these indications in the aforementioned studies.
•Additional trials with registrational potential are planned to be initiated in 2024.
BNT325/DB-1305 is an ADC candidate targeting Trophoblast Cell-surface Antigen 2 (“TROP2”) that is being developed in collaboration with DualityBio.
•Data from the ongoing Phase 1/2 clinical trial (NCT05438329) were presented at the 2023 European Society for Medical Oncology (“ESMO”) Annual Meeting. The dose range with manageable safety profile was determined. Encouraging preliminary activity was observed in heavily pretreated patients with advanced/metastatic solid tumors.
•In November 2023, two new cohorts were added to the study: one to evaluate BNT325/DB-1305 monotherapy in cervical cancer, and one to assess the combination of BNT325/DB-1305 with pembrolizumab in non-small cell lung cancer (“NSCLC”).
•In January 2024, BioNTech and DualityBio received Fast Track designation for BNT325/DB-1305 from the FDA for the treatment of patients with platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.
Next-Generation Immune Checkpoint Immunomodulator Programs
BNT316/ONC-392 (gotistobart) is an anti-CTLA-4 monoclonal antibody candidate being developed in collaboration with OncoC4, Inc. (“OncoC4”).
•In June 2023, a Phase 3 clinical trial (NCT05671510) was initiated to evaluate BNT316/ONC-392 (monotherapy in patients with metastatic NSCLC whose disease progressed on anti-PD-1/PD-L1 antibody-based therapy.
•In November 2023, clinical data from the ongoing Phase 1/2 trial (NCT04140526) were presented at the Society for Immunotherapy of Cancer (”SITC”) Annual Meeting in which BNT316/ONC-392 was observed to have a manageable safety profile. The data also included encouraging clinical activity observations in patients with immunotherapy-resistant NSCLC, which informed the decision to proceed the Phase 3 clinical trial.
•In December 2023, the first patient was dosed in a Phase 1/2 clinical trial (NCT05682443) to evaluate the efficacy and safety of BNT316/ONC-392 in combination with the radioligand therapy, lutetium (177Lu) vipivotide tetraxetan in patients with metastatic castration-resistant prostate cancer (“mCRPC”) who have progressed on an androgen receptor pathway inhibitor.
BNT311/GEN1046 (acasunlimab) is a potential first-in-class bispecific antibody candidate combining PD-L1 checkpoint inhibition with 4-1BB costimulatory activation that is being developed in collaboration with Genmab S/A (“Genmab”).
•Based on emerging clinical data, the companies are engaging with health authorities on the design of a Phase 3 trial in second-line NSCLC. The companies intend to share initial data at a medical conference in the first half of 2024 from an ongoing Phase 2 randomized, open-label clinical trial (NCT05117242) evaluating BNT311/GEN1046 as monotherapy and in combination with pembrolizumab in patients with relapsed/refractory metastatic NSCLC and a tumor PD-L1 expression of tumor proportion score of ≥1% after treatment with standard-of-care therapy with an immune-checkpoint inhibitor. The primary endpoint is objective response rate according to Response Evaluation Criteria in Solid Tumors (“RECIST v1.1”). Secondary endpoints include duration of response, time to response, progression-free survival, overall survival and safety.
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BNT312/GEN1042 is a potential first-in-class bispecific antibody candidate designed to induce conditional immune activation by crosslinking CD40 and 4-1BB positive cells that is being developed in collaboration with Genmab.
•The companies intend to share updated data at a medical conference in the second half of 2024 from an ongoing Phase 1/2 dose-escalation clinical trial (NCT04083599) with expansion cohorts evaluating safety and anti-tumor activity of BNT312/GEN1042 as monotherapy and in combination therapies in patients with solid tumors. The companies also expect to determine next steps for this program in 2024.
BNT327/PM8002 is an anti-VEGF-A antibody candidate fused to a humanized anti-PD-L1 VHH that is being developed in collaboration with Biotheus Inc. (“Biotheus”). BNT327/PM8002 is currently being evaluated in Phase 1 and Phase 2/3 clinical trials in China to assess the efficacy and safety of the candidate as a monotherapy or in combination with chemotherapy in various indications, including in first line small-cell lung cancer (“SCLC”) and second-line Epidermal Growth Factor Receptor (“EGFR”)-mutated NSCLC.
•Data from a Phase 1/2 clinical trial in advanced solid tumors presented in 2023 indicate that BNT327/PM8002 monotherapy may have antitumor activity and a manageable safety profile.
•Data from Phase 2 trials in patients with SCLC and triple-negative breast cancer (“TNBC”) presented in 2023 indicate that BNT327/PM8002 in combination with chemotherapy may have encouraging antitumor activity and an acceptable toxicity profile as second and first-line therapy, respectively.
•An Investigational New Drug (“IND”) application has been accepted by the FDA for further studies in the United States. Global trials are planned to start in 2024.
Cancer Vaccine Programs
BNT116 is based on BioNTech’s FixVac platform, and is a wholly owned, systemically administered, off-the-shelf uridine mRNA-lipoplex based cancer vaccine candidate encoding six shared lung cancer associated antigens. BNT116 is being evaluated for the treatment of advanced NSCLC.
•A randomized, controlled Phase 2 clinical trial (NCT05557591) is ongoing to evaluate BNT116 in combination with cemiplimab versus cemiplimab alone as first-line treatment in patients with advanced NSCLC whose tumors express PD-L1 in ≥ 50% of tumor cells.
•In November 2023, data from the ongoing Phase 1 clinical trial (NCT05142189) evaluating the safety, tolerability and preliminary efficacy of BNT116 alone and in combination with cemiplimab or chemotherapy were presented at the 2023 SITC Annual Meeting. BNT116 was observed to be generally well tolerated with an expected safety profile as monotherapy and in combination with cemiplimab. In heavily pretreated NSCLC patients, early clinical activity was observed with treatment with BNT116 with the addition of cemiplimab from cycle 3 onward.
•Additional data from a different cohort of this Phase 1 clinical trial evaluating BNT116 in combination with docetaxel in patients with NSCLC that progressed on prior anti-PD(L)-1 therapy will be presented at the 2024 American Association of Cancer Research ("AACR") Annual Meeting in April 2024.
Autogene cevumeran (BNT122) is an uridine mRNA-lipoplex based cancer vaccine candidate for individualized neoantigen-specific immunotherapy ("iNeST") being developed in collaboration with Genentech, Inc. ("Genentech"), a member of the Roche Group (“Roche”).
•In October 2023, BioNTech announced the initiation of a Phase 2 trial (NCT05968326) evaluating the efficacy and safety of BNT122 in combination with the anti-PD-L1 immune checkpoint inhibitor atezolizumab and standard of care chemotherapy in patients with resected pancreatic ductal adenocarcinoma ("PDAC").
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•Follow-up data from the investigator-initiated Phase 1 trial in patients with resected PDAC which informed and motivated the Phase 2 trial, are due to be presented at the AACR Annual Meeting in April 2024. The results of the Phase 1 trial were published in Nature (Rojas et al., Nature 2023).
•An additional Phase 2 clinical trial is planned to be initiated as early as 2024.
Cell Therapy Programs
BNT211 is a CAR-T cell product candidate targeting Claudin-6 ("CLDN6")-positive solid tumors that is combined with a CAR-T cell-amplifying RNA vaccine ("CARVac") encoding CLDN6.
•An open-label, multi-center Phase 1/2 dose escalation and dose expansion basket trial (NCT04503278) evaluating CLDN6 CAR-T cells with or without a CLDN6 CARVac in CLDN6-positive relapsed or refractory advanced solid tumors, including ovarian and testicular cancers, is ongoing. Data from this trial were reported at several conferences, including ASCO and ESMO 2023. Encouraging signs of activity were observed. In several patients treated with CARVac, an increased persistence of CLDN6 CAR-T cells was observed. The rate of treatment-dependent adverse event was dose-dependent and further evaluation is ongoing to determine the CLDN6 CAR T dose with manageable safety.
•A pivotal Phase 2 clinical trial in relapsed/refractory germ cell tumors is planned to start in 2024.
Select Infectious Disease Pipeline Highlights
Beyond BioNTech’s portfolio of variant-adapted, next-generation and combination respiratory programs, the Company is developing vaccine modalities against multiple pathogens that pose a threat to public health and have a significant global health burden.
In 2023, BioNTech initiated three first-in-human Phase 1 clinical trials leveraging its proprietary mRNA prophylactic vaccine technology. These trials are for vaccine candidates addressing shingles (NCT05703607), tuberculosis (NCT05537038, Germany and NCT05547464, Republic of South Africa), and mpox (NCT05988203).
Corporate Update for 2023 and Key Post Period-End Events
In 2023, BioNTech strategically forged a series of complementary agreements and collaborations, including:
•The acquisition of its long-time strategic collaboration partner, InstaDeep Ltd (“InstaDeep”), which provides BioNTech with capabilities to leverage artificial intelligence (AI) and machine learning (ML) technologies across its therapeutic platforms and operations. With this acquisition, BioNTech has added industry-leading AI and ML capabilities and approximately 290 highly skilled professionals to its organization. InstaDeep is operating as a London-based subsidiary of BioNTech.
•New collaborations with DualityBio and MediLink Therapeutics (Suzhou) Co., Ltd. ("MediLink") which expanded BioNTech's technology base into ADCs, and collaborations with OncoC4 and Biotheus that have complemented the Company's pipeline with mid-to-late-stage novel immunomodulators.
•A strategic partnership with the Government of the United Kingdom ("UK") aiming to lead to personalized mRNA cancer immunotherapies reaching up to 10,000 patients by 2030. BioNTech also plans to invest in a research and development hub in Cambridge, UK, which is expected to employ more than 70 additional highly skilled scientists.
•A multi-year strategic partnership with the State of Victoria, Australia, to set up and operate a clinical-scale mRNA manufacturing facility through its BioNTainers, BioNTech’s modular, state-of-the-art mRNA manufacturing solution, and to establish an mRNA Innovation Center in Melbourne.
Over the last 12 months, BioNTech expanded its organization in Asia, Africa, North America, Australia and Europe. The Company increased its research and development and production capabilities and
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completed construction of its first proprietary plasmid DNA manufacturing facility in Marburg, Germany. BioNTech also delivered and set up the first BioNTainer for its site in Kigali, Rwanda.
In February 2024, BioNTech entered into a strategic collaboration with Autolus Therapeutics plc ("Autolus") aimed at advancing both companies’ autologous CAR-T programs towards commercialization, pending regulatory authorizations. The collaboration also grants BioNTech the option to access a suite of Autolus’ target binders and cell programming technologies to support BioNTech’s development of in vivo cell therapy and ADC candidates.
In March 2024, BioNTech announced that Sean Marett, Chief Business and Commercial Officer, will retire as planned from the Management Board of BioNTech. As of July 1, 2024, Sean Marett will continue as a specialist advisor to the Company at least until the end of the year. As announced earlier today, Annemarie Hanekamp will be joining the Company's Management Board as Chief Commercial Officer on July 1, 2024. Sean Marett’s responsibilities as Chief Business Officer are being gradually transferred to James Ryan, Ph.D., Chief Legal Officer, who joined the Management Board in September 2023 and who will also take on the role as Chief Business Officer of BioNTech at the end of the transition phase and upon Sean Marett’s retirement.
Environmental, Social, and Governance (ESG)
In February 2024, the Company’s near-term science-based emissions reduction targets were approved by the Science Based Targets initiative (“SBTi”). This validation underscores the ambitious nature of BioNTech’s scope 1 and scope 2 climate targets and is intended to align with the United Nations' Paris Climate Agreement to limit global warming to 1.5 degrees Celsius above pre-industrial levels. More information on BioNTech’s Scope 1, 2 and 3 targets can be found in the Company's press release dated February 12, 2024.
BioNTech's performance on environmental, social, and governance matters is regularly assessed by external rating agencies. The Institutional Shareholder Services Group ("ISS") currently assigns BioNTech a "Prime" ESG rating: the Company has received an overall corporate rating of B-, which is among the top 10% of all rated companies in the pharmaceutical and biotechnology sector. In the ISS Governance Quality Score, BioNTech stands at 5 on a risk scale of 1 (low risk) to 10 (high risk). S&P Global Ratings has rated BioNTech in the S&P Corporate Sustainability Assessment 2023 ("CSA") with an S&P Global CSA score of 45 (2022: 32) out of 100. Morningstar Sustainalytics has given BioNTech a Sustainalytics ESG rating of 24.1 (2022: 22.3), which corresponds to a "medium risk", the third of five risk levels (negligible, low, medium, high and severe).
BioNTech publishes its ESG report (Sustainability Report 2023) today, March 20, 2024. The report is being made available on the Investors' section of BioNTech’s website.
Upcoming Investor and Analyst Events
•Annual General Meeting: May 17, 2024
•Innovation Series (Digital & AI Day): October 1, 2024
•Innovation Series: November 14, 2024
Conference Call and Webcast Information
BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, March 20, 2024, at 8:00 a.m. ET (1:00 p.m. CET) to report its financial results and provide a corporate update for the fourth quarter and financial year 2023.
To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a pin number will be provided.
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The slide presentation and audio of the webcast will be available via this link.
Participants may also access the slides and the webcast of the conference call via the “Events & Presentations” page of the Investors' section of the Company’s website at https://biontech.com. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.
About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Biotheus, DualityBio, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, OncoC4, Pfizer and Regeneron.
For more information, please visit www.BioNTech.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech's expected revenues and net profit related to sales of BioNTech's COVID-19 vaccine, referred to as COMIRNATY where approved for use under full or conditional marketing authorization, in territories controlled by BioNTech's collaboration partners, particularly for those figures that are derived from preliminary estimates provided by BioNTech's partners; the rate and degree of market acceptance of BioNTech's COVID-19 vaccine and, if approved, BioNTech's investigational medicines; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment and expected regulatory recommendations to adapt vaccines to address new variants or sublineages; the initiation, timing, progress, results, and cost of BioNTech's research and development programs, including those relating to additional formulations of BioNTech's COVID-19 vaccine, and BioNTech's current and future preclinical studies and clinical trials, including statements regarding the timing of initiation, enrollment, and completion of studies or trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations; BioNTech's expectations with respect to its intellectual property; the impact of BioNTech's collaboration and licensing agreements and its acquisition of InstaDeep Ltd.; the development, nature and feasibility of sustainable vaccine production and supply solutions; and BioNTech's estimates of revenues, research and development expenses, cost of sales, general and administrative expenses, and capital expenditures for operating activities. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements.
9
These risks and uncertainties include, but are not limited to: BioNTech's pricing and coverage negotiations regarding its COVID-19 vaccine with governmental authorities, private health insurers and other third-party payors after BioNTech's initial sales to national governments; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; competition from other COVID-19 vaccines or related to BioNTech's other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the timing of and BioNTech's ability to obtain and maintain regulatory approval for BioNTech's product candidates; the ability of BioNTech’s COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech's and its counterparties’ ability to manage and source necessary energy resources; BioNTech's ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech's third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; the impact of the COVID-19 pandemic on BioNTech's development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of BioNTech's COVID-19 vaccine and other products and product candidates developed or manufactured by BioNTech; BioNTech's and its collaborators’ ability to commercialize and market BioNTech's COVID-19 vaccine and, if approved, its product candidates; BioNTech's ability to manage its development and expansion; regulatory developments in the United States and other countries; BioNTech's ability to effectively scale its production capabilities and manufacture its products, including target COVID-19 vaccine production levels, and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time.
You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech's Annual Report on Form 20-F for the year ended December 31, 2023 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at https://www.sec.gov/. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on BioNTech’s current expectations and speak only as of the date hereof.
CONTACTS
Investor Relations
Victoria Meissner, M.D.
+1 617 528 8293
Investors@biontech.de
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
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Statements of Profit or Loss
Three months ended December 31, | Years ended December 31, | ||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | 2021 | |||||||||||||
| (in millions €, except per share data) | (unaudited) | (unaudited) | |||||||||||||||
| Revenues | |||||||||||||||||
| Commercial revenues | 1,478.9 | 4,271.3 | 3,815.5 | 17,194.6 | 18,874.0 | ||||||||||||
| Research & development revenues | 0.1 | 7.0 | 3.5 | 116.0 | 102.7 | ||||||||||||
| Total revenues | 1,479.0 | 4,278.3 | 3,819.0 | 17,310.6 | 18,976.7 | ||||||||||||
| Cost of sales | (179.1) | (183.5) | (599.8) | (2,995.0) | (2,911.5) | ||||||||||||
| Research and development expenses | (577.8) | (509.8) | (1,783.1) | (1,537.0) | (949.2) | ||||||||||||
| Sales and marketing expenses | (18.0) | (14.6) | (62.7) | (59.5) | (50.4) | ||||||||||||
| General and administrative expenses | (124.3) | (119.9) | (495.0) | (481.7) | (276.8) | ||||||||||||
Other operating expenses (1) | (57.6) | (379.2) | (293.0) | (410.0) | (103.4) | ||||||||||||
Other operating income (1) | 4.0 | 221.6 | 105.0 | 815.3 | 598.4 | ||||||||||||
| Operating income | 526.2 | 3,292.9 | 690.4 | 12,642.7 | 15,283.8 | ||||||||||||
| Finance income | 162.2 | 38.8 | 519.6 | 330.3 | 67.7 | ||||||||||||
| Finance expenses | (25.2) | (159.1) | (23.9) | (18.9) | (305.1) | ||||||||||||
| Profit before tax | 663.2 | 3,172.6 | 1,186.1 | 12,954.1 | 15,046.4 | ||||||||||||
| Income taxes | (205.3) | (893.9) | (255.8) | (3,519.7) | (4,753.9) | ||||||||||||
| Profit for the period | 457.9 | 2,278.7 | 930.3 | 9,434.4 | 10,292.5 | ||||||||||||
| Earnings per share | |||||||||||||||||
| Basic earnings for the period per share | 1.91 | 9.38 | 3.87 | 38.78 | 42.18 | ||||||||||||
| Diluted earnings for the period per share | 1.90 | 9.26 | 3.83 | 37.77 | 39.63 | ||||||||||||
(1) Adjustments to prior-year figures due to change in functional allocation of general and administrative expenses and other operating expenses
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Statements of Financial Position
| December 31, | December 31, | ||||||||||
| (in millions €) | 2023 | 2022 | |||||||||
| Assets | |||||||||||
| Non-current assets | |||||||||||
| Goodwill | 362.5 | 61.2 | |||||||||
| Other intangible assets | 804.1 | 158.5 | |||||||||
| Property, plant and equipment | 757.2 | 609.2 | |||||||||
| Right-of-use assets | 214.4 | 211.9 | |||||||||
| Other financial assets | 1,176.1 | 80.2 | |||||||||
| Other non-financial assets | 83.4 | 6.5 | |||||||||
| Deferred tax assets | 81.3 | 229.6 | |||||||||
| Total non-current assets | 3,479.0 | 1,357.1 | |||||||||
| Current assets | |||||||||||
| Inventories | 357.7 | 439.6 | |||||||||
| Trade and other receivables | 2,155.7 | 7,145.6 | |||||||||
| Contract assets | 4.9 | — | |||||||||
| Other financial assets | 4,885.3 | 189.4 | |||||||||
| Other non-financial assets | 280.9 | 271.9 | |||||||||
| Income tax assets | 179.1 | 0.4 | |||||||||
| Cash and cash equivalents | 11,663.7 | 13,875.1 | |||||||||
| Total current assets | 19,527.3 | 21,922.0 | |||||||||
| Total assets | 23,006.3 | 23,279.1 | |||||||||
| Equity and liabilities | |||||||||||
| Equity | |||||||||||
| Share capital | 248.6 | 248.6 | |||||||||
| Capital reserve | 1,229.4 | 1,828.2 | |||||||||
| Treasury shares | (10.8) | (5.3) | |||||||||
| Retained earnings | 19,763.3 | 18,833.0 | |||||||||
| Other reserves | (984.6) | (848.9) | |||||||||
| Total equity | 20,245.9 | 20,055.6 | |||||||||
| Non-current liabilities | |||||||||||
| Lease liabilities, loans and borrowings | 191.0 | 176.2 | |||||||||
| Other financial liabilities | 38.8 | 6.1 | |||||||||
| Income tax liabilities | — | 10.4 | |||||||||
| Provisions | 8.8 | 8.6 | |||||||||
| Contract liabilities | 398.5 | 48.4 | |||||||||
| Other non-financial liabilities | 13.1 | 17.0 | |||||||||
| Deferred tax liabilities | 39.7 | 6.2 | |||||||||
| Total non-current liabilities | 689.9 | 272.9 | |||||||||
| Current liabilities | |||||||||||
| Lease liabilities, loans and borrowings | 28.1 | 36.0 | |||||||||
| Trade payables and other payables | 354.0 | 204.1 | |||||||||
| Other financial liabilities | 415.2 | 785.1 | |||||||||
| Refund liabilities | — | 24.4 | |||||||||
| Income tax liabilities | 525.5 | 595.9 | |||||||||
| Provisions | 269.3 | 367.2 | |||||||||
| Contract liabilities | 353.3 | 77.1 | |||||||||
| Other non-financial liabilities | 125.1 | 860.8 | |||||||||
| Total current liabilities | 2,070.5 | 2,950.6 | |||||||||
| Total liabilities | 2,760.4 | 3,223.5 | |||||||||
| Total equity and liabilities | 23,006.3 | 23,279.1 | |||||||||
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Statements of Cash Flows
Three months ended December 31, | Years ended December 31, | |||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | 2021 | ||||||||||||||||
| (in millions €) | (unaudited) | (unaudited) | ||||||||||||||||||
| Operating activities | ||||||||||||||||||||
| Profit for the period | 457.9 | 2,278.7 | 930.3 | 9,434.4 | 10,292.5 | |||||||||||||||
| Income taxes | 205.3 | 893.9 | 255.8 | 3,519.7 | 4,753.9 | |||||||||||||||
| Profit before tax | 663.2 | 3,172.6 | 1,186.1 | 12,954.1 | 15,046.4 | |||||||||||||||
| Adjustments to reconcile profit before tax to net cash flows: | ||||||||||||||||||||
| Depreciation and amortization of property, plant, equipment, intangible assets and right-of-use assets | 78.8 | 29.0 | 183.4 | 123.3 | 75.2 | |||||||||||||||
| Share-based payment expenses | 14.2 | 22.2 | 51.4 | 108.6 | 93.9 | |||||||||||||||
| Net foreign exchange differences | 66.3 | 847.8 | (298.0) | 625.5 | (387.5) | |||||||||||||||
| Loss on disposal of property, plant and equipment | 0.2 | 0.2 | 3.8 | 0.6 | 4.6 | |||||||||||||||
| Finance income excluding foreign exchange differences | (162.2) | (38.8) | (519.6) | (265.3) | (1.5) | |||||||||||||||
| Finance expense excluding foreign exchange differences | 3.4 | 2.1 | 7.9 | 18.9 | 305.2 | |||||||||||||||
| Movements in government grants | 5.4 | 0.3 | 2.4 | 0.3 | (89.0) | |||||||||||||||
| Net (gain) / loss on derivative instruments at fair value through profit or loss | (21.2) | (323.3) | 175.5 | (241.0) | 57.3 | |||||||||||||||
| Working capital adjustments: | ||||||||||||||||||||
| Decrease / (increase) in trade and other receivables, contract assets and other assets | (288.0) | (646.8) | 5,374.0 | 4,369.9 | (11,808.1) | |||||||||||||||
| Decrease / (increase) in inventories | 58.0 | (144.8) | 81.9 | 62.9 | (438.4) | |||||||||||||||
| Increase in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions | 412.8 | (674.6) | 118.9 | 85.7 | 1,516.1 | |||||||||||||||
| Interest received and realized gains from cash and cash equivalents | 91.8 | 22.8 | 258.2 | 29.3 | 1.2 | |||||||||||||||
| Interest paid and realized losses from cash and cash equivalents | (1.7) | (5.0) | (5.4) | (21.5) | (12.2) | |||||||||||||||
| Income tax paid | (65.1) | (1,387.4) | (482.9) | (4,222.1) | (3,457.9) | |||||||||||||||
| Share-based payments | (5.0) | (47.1) | (766.2) | (51.8) | (13.4) | |||||||||||||||
| Net cash flows from operating activities | 850.9 | 829.2 | 5,371.4 | 13,577.4 | 889.7 | |||||||||||||||
| Investing activities | ||||||||||||||||||||
| Purchase of property, plant and equipment | (83.8) | (136.6) | (249.4) | (329.2) | (127.5) | |||||||||||||||
| Proceeds from sale of property, plant and equipment | 0.1 | 0.2 | (0.7) | 0.6 | 3.4 | |||||||||||||||
| Purchase of intangible assets and right-of-use assets | (106.5) | (7.9) | (455.4) | (34.1) | (26.5) | |||||||||||||||
| Acquisition of subsidiaries and businesses, net of cash acquired | — | — | (336.9) | — | (20.8) | |||||||||||||||
| Investment in other financial assets | (3,418.2) | (16.7) | (7,128.4) | (47.8) | (19.5) | |||||||||||||||
13
| Proceeds from maturity of other financial assets | 913.3 | — | 1,216.3 | 375.2 | (375.2) | |||||||||||||||
| Net cash flows used in investing activities | (2,695.1) | (161.0) | (6,954.5) | (35.3) | (566.1) | |||||||||||||||
| Financing activities | ||||||||||||||||||||
| Proceeds from issuance of share capital and treasury shares, net of costs | — | — | — | 110.5 | 160.9 | |||||||||||||||
| Proceeds from loans and borrowings | 0.2 | 0.2 | 0.3 | 0.8 | — | |||||||||||||||
| Repayment of loans and borrowings | — | — | (0.1) | (18.8) | (52.6) | |||||||||||||||
| Payments related to lease liabilities | (12.3) | (9.2) | (40.3) | (41.1) | (14.1) | |||||||||||||||
| Share repurchase program | (0.8) | (55.7) | (738.5) | (986.4) | — | |||||||||||||||
| Dividends | — | — | — | (484.3) | — | |||||||||||||||
| Net cash flows from / (used in) financing activities | (12.9) | (64.7) | (778.6) | (1,419.3) | 94.2 | |||||||||||||||
| Net increase / (decrease) in cash and cash equivalents | (1,857.1) | 603.5 | (2,361.7) | 12,122.8 | 417.8 | |||||||||||||||
| Change in cash and cash equivalents resulting from exchange rate differences | (15.4) | (152.1) | (14.5) | 60.1 | 64.7 | |||||||||||||||
| Cash and cash equivalents at the beginning of the period | 13,495.8 | 13,423.7 | 13,875.1 | 1,692.7 | 1,210.2 | |||||||||||||||
| Cash and cash equivalents as of December 31 | 11,663.7 | 13,875.1 | 11,663.7 | 13,875.1 | 1,692.7 | |||||||||||||||
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4th Quarter 2023 Financial Results & Corporate Update March 20, 2024 Exhibit 99.1
This Slide Presentation Includes Forward-Looking Statements 2 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech's expected revenues and net profit related to sales of BioNTech's COVID-19 vaccine, referred to as COMIRNATY® where approved for use under full or conditional marketing authorization, in territories controlled by BioNTech's collaboration partners, particularly for those figures that are derived from preliminary estimates provided by BioNTech's partners; the rate and degree of market acceptance of BioNTech's COVID-19 vaccine and, if approved, BioNTech's investigational medicines; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment, seasonality and expected regulatory recommendations to adapt vaccines to address new variants or sublineages; the initiation, timing, progress, results, and cost of BioNTech's research and development programs, including those relating to additional formulations of BioNTech's COVID-19 vaccine, and BioNTech's current and future preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work and the availability of results; our expectations with respect to our intellectual property; the impact of the Company’s collaboration and licensing agreements; the development of sustainable vaccine production and supply solutions and the nature and feasibility of these solutions; and BioNTech's estimates of commercial and other revenues, cost of sales, research and development expenses, sales and marketing expenses, general and administrative expenses, capital expenditures, income taxes, net profit, cash, cash equivalents and security investments, shares outstanding and cash outflows and share consideration. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this presentation are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control, and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: BioNTech's pricing and coverage negotiations with governmental authorities, private health insurers and other third-party payors after BioNTech's initial sales to national governments; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; competition from other COVID-19 vaccines or related to BioNTech's other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the timing of and BioNTech's ability to obtain and maintain regulatory approval for BioNTech's product candidates; the ability of BioNTech’s COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech's and its counterparties’ ability to manage and source necessary energy resources; BioNTech's ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech's third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; the impact of the COVID-19 pandemic on BioNTech's development programs, supply chain, collaborators and financial performance; unforeseen safety issues and claims for potential personal injury or death arising from the use of BioNTech's COVID-19 vaccine and other products and product candidates developed or manufactured by BioNTech; BioNTech's and its collaborators’ ability to commercialize and market BioNTech's COVID-19 vaccine and, if approved, its product candidates; BioNTech's ability to manage its development and expansion; regulatory developments in the United States and other countries; BioNTech's ability to effectively scale BioNTech's production capabilities and manufacture BioNTech's products, including BioNTech's target COVID-19 vaccine production levels, and BioNTech's product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 20-F for the period ended December 31, 2023 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at https://www.sec.gov/. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this presentation in the event of new information, future developments or otherwise. These forward-looking statements are based on BioNTech’s current expectations and speak only as of the date hereof.
Financial Results Jens Holstein, Chief Financial Officer3 Strategic Outlook Ryan Richardson, Chief Strategy Officer4 Pipeline Update Özlem Türeci, Co-founder & Chief Medical Officer2 4th Quarter and FY 2023 Highlights Ugur Sahin, Co-founder & Chief Executive Officer1
1 4th Quarter and FY 2023 Highlights Ugur Sahin, Founder & Chief Executive Officer
Our Vision: Harnessing the Power of the Immune System to Fight Human Disease 5 AI = artificial intelligence. Innovative precision medicine pipeline targeting multiple product approvals in oncology in the coming years Multi-product immunotherapy pioneer addressing medical need worldwide Sustainable respiratory vaccine business Powered by breakthrough science, disruptive technologies & AI BioNTech’s key objectives for the next phase Elevating success beyond our historical achievement
Developing an Innovative Pipeline Focused on Oncology and Infectious Disease 6 1. Partnered with DualityBio; 2. Partnered with OncoC4; 3. Partnered with Regeneron; 4. Partnered with Genentech, member of Roche Group; 5. Partnered with Genmab; 6. Partnered with MediLink Therapeutics; 7. Partnered with Biotheus; 8. Partnered with Pfizer; 9. In collaboration with Bill & Melinda Gates Foundation; 10. Partnered with the Coalition for Epidemic Preparedness Innovations (CEPI). NSCLC = non-small cell lung cancer; PDAC = pancreatic ductal adenocarcinoma; CRC = colorectal cancer; HPV = human papilloma virus; HNSCC = head and neck squamous cell carcinoma; Mpox = monkey pox. Oncology Infectious Disease 7 clinical trials started across platforms 3 first-in-human trials started: Tuberculosis9 Shingles8 Mpox10 22 clinical stage programs 7 clinical stage programs Rigorous pipeline prioritization guided by clinical data and unmet medical need Ph3: BNT323/DB-13031 l BNT316/ONC-3922 Ph2: BNT1163 l autogene cevumeran/BNT1224 Ph1/2: BNT324/DB-13111 l BNT314/GEN10595 Ongoing mid- to late- stage trials: NSCLC BNT316/ONC-3922 l BNT311/GEN10465 l BNT1163 Endometrial cancer BNT323/DB-13031 Breast cancer BNT323/DB-13031 PDAC autogene cevumeran/BNT1224 CRC autogene cevumeran/BNT1224 HPV+ HNSCC BNT113 Melanoma autogene cevumeran/BNT1224 l BNT111 6 clinical assets in-licensed Antibody-drug conjugates: BNT323/DB-13031 BNT324/DB-13111 BNT325/DB-13051 BNT326/YL2026 Antibodies: BNT316/ ONC-3922 PM80027 Clinical and scientific execution in 2023Our pipeline
Aim to recruit patients with multiple indications in 2024 >2,000 patients recruited for ADC & IO programs Accelerating Development of our ADC and IO Programs Across Indications 1. Partnered with OncoC4; 2. Partnered with Biotheus; 3. Partnered with DualityBio; 4: Partnered with Medilink CTLA4 = cytotoxic T-lymphocyte-associated protein 4; PD-L1 =programmed cell death protein ligand 1; ADC = antibody-drug conjugates; IO = immuno oncology; HER2/3 = human epidermal growth factor receptor 2/3; TROP2 = trophoblast cell-surface antigen; (N)SCLC = (non-)small cell lung cancer; (TN)BC = (triple-negative) breast cancer; OC = ovarian cancer; CRC = colorectal cancer; PDAC = pancreatic ductal adenocarcinoma; HCC = hepatocellular cancer; mCRPC = metastaci castration-resistant prostate cancer; RCC = renal cell cancer; HNSCC = head and neck squamous cell carcinoma Patient recruitment metrics in 2022 & 2023 Goal for 2024 Lung Cancer (NSCLC, SCLC) Breast Cancer (HR+ BC, TNBC) Gynecological cancers (Endometrial, Plat-resistant OC, Cervical Cancer) Gastrointestinal cancers (CRC, Gastric, PDAC, Esophageal, HCC ) Genitourinary cancers (mCRPC, RCC) Melanoma HNSCC BNT316/ ONC-3921 (gotistobart) Anti-CTLA4 >650 15 indications BNT327/ PM80022 Anti-PD-L1xVEGF >600 11 indications BNT323/ DB-13033 HER2 ADC >350 4 indications BNT325/ DB-13053 TROP2 ADC >150 5 indications BNT326/ YL2024 HER3 ADC >100 13 indications BNT324/ DB-13113 B7H3 ADC >50 7 indications Data publications from these trials across multiple indications are planned for 2024
Corporate Execution in 2023 and Post-Period 1. Consists of €11,663.7 million cash and cash equivalents and €5,989.7 million security investments as of December 31, 2023 AI = artificial intelligence; ADC = antibody drug conjugate; IO = immune oncology; CAR = chimeric antigen receptor 8 Strong cash position ~€ 17.7 bn total cash plus security investments1 Continued progress towards building a multi-product, AI-powered, patient-centric company embedded in the biotech ecosystem Acquired InstaDeep Strategic alliance with AutolusIn-licensed 6 new clinical stage candidates Integrating capabilities in super- computing, AI research and generative AI into various processes Adding new ADCs and next-generation IO antibodies Advancing CAR-T programs towards potential commercialization
Aiming for Meaningful Impact with BNT211 in Patients with CLDN6+ Tumors Data cut-off: 10 Sep 2023. Waterfall plot showing best percent change from baseline in sum of target lesion diameters for patients treated with CLDN6 CAR-T (N = 38). One patient died prior to first assessment (NR = not reached) and BOR was defined as PD. * Patients had non-measurable disease per RECIST 1.1 and BOR was assessed by tumor marker response. ** Patient achieved complete response after surgical removal of tumors. Response data was pending for 6 patients at the data cutoff. Dotted lines show standard response evaluation criteria used to determine objective tumor response for target lesions per RECIST 1.1 (CR = –100%, PR = 30 to –100%, SD = –30 to 20%, and PD = 20% or higher). Graph contains additional data from 5 patients entered manually into the database following the data cut-off date that was not available in formal outputs. BOR = best overall response; CR = complete response; DCR = disease control rate; DL = dose level; EOC = epithelial ovarian cancer; GCT = germ cell tumor; PD = progressive disease; ORR = objective response rate; PR = partial response; SD = stable disease; NSCLC = non-small cell lung cancer. C h a n g e i n t a rg e t s u m [ % ] 60 30 0 -30 -60 -90 GCT EOC Others NR * * DL 1 1 2 0 3 2 2 1 1 3 2 2 1 1 0 2 3 3 2 2 2 2 3 2 2 2 3 2 2 2 1 2 2 2 3 2 2 2 BOR PD PD PD PD PD SD SD PD PD PR PR SD PD PD SD SD SD SD SD SD PR PR SD PR SD PR PD SD PR PR PR PR PR PR PR PR PR CR ** Best response and change in target sum (all DLs ± CLDN6 CARVac ) Antitumor activity seen in multiple CLDN6+ tumor types Haanen J. et al. Presented at ESMO 2023. Abstract #LBA35. 9 Addressable patient population Tumor type Total addressable patient population per year in G7 Germ cell tumors ~1,000 Ovarian cancer ~10,000 NSCLC ~6,000
Towards a Potentially Curative Approach to Cancer: Differentiated Combinations Space for potentially curative approaches Immunomodulators Novel checkpoint inhibitors, cytokines, immune agonists mRNA vaccines Targeted therapy ADCs, CAR-T, TCR-T, small molecules SynergySynergy Synergy 10 CAR = chimeric antigen receptor; ADC = antibody-drug conjugate; IO = immune oncology; TCR-T = T-cell receptor engineered T cell. Immunomodulators • Our modality agnostic armamentarium aims to focus on the most relevant and crucial IO pathways • Targeting different but complementary players in the complex cancer immunity cycle may promote a thorough and durable anti-tumoral effect mRNA cancer vaccines • Could eliminate polyclonal residual disease with individualized vaccines for potential long-term impact • Polyspecific activity by targeting multiple antigens at once Targeted therapy • Potent and precise therapies could rapidly reduce tumor burden • Designed to have clinical efficacy across the entire disease continuum including late lines
Pipeline Update Özlem Türeci, Co-Founder & Chief Medical Officer
Our Multi-Platform Immuno-Oncology Pipeline Today 12 1. Partnered with Genentech, member of Roche Group; 2. Partnered with Regeneron; 3. Partnered with Genmab; 4. Partnered with OncoC4; 5. Partnered with DualityBio; 6. Partnered with MediLink Therapeutics. *Two phase 1/2 clinical trials in patients with solid tumors are ongoing in combination with immune checkpoint inhibitor +/- chemotherapy. ** Phase 2 expansion cohort of Ph1/2 trial (NCT05150691). NSCLC = non-small cell lung cancer; mCRPC = metastatic castration resistant prostate cancer; HPV = human papillomavirus; PDAC = pancreatic ductal adenocarcinoma; CRC = colorectal cancer; CLDN = claudin; IL = interleukin; 1L = first line; R/R = relapsed/refractory; HER2/HER3 = human epidermal growth factor 2/3; sLeA = sialyl-Lewis A antigen; TROP2 = tumor-associated calcium transducer 2. Phase 1 Phase 1/2 Phase 2 Phase 3 BNT211 (CLDN6) Multiple solid tumors BNT311/GEN10463 (acasunlimab) Multiple solid tumors BNT312/GEN10423 * (CD40x4-1BB) Multiple solid tumors BNT313/GEN10533 (CD27) Multiple solid tumors BNT316/ONC-392 (gotistobart)4 (CTLA-4) Multiple solid tumors BNT151 (IL-2 variant) Multiple solid tumors BNT142 (CD3xCLDN6) Multiple CLDN6-pos. adv. solid tumors BNT325/DB-13055 (TROP2) Multiple solid tumors BNT316/ONC-392 (gotistobart)4 (CTLA-4) anti-PD-1/PD-L1 experienced NSCLC BNT323/DB-13035 (HER2) Multiple solid tumors BNT324/DB-13115 (B7H3) Multiple solid tumors BNT323/DB-13035 (HER2) 2L+ HR+, HER2-low met. breast cancer BNT116 Adv. NSCLC BNT152 + BNT153 (IL-7, IL-2) Multiple solid tumors BNT221 Refractory metastatic melanoma BNT321 (sLea) Metastatic PDAC BNT322/GEN10564 Multiple solid tumors Autogene cevumeran/BNT1221 Multiple solid tumors BNT314//GEN10593 (EpCAMx4-1BB) Multiple solid tumors mRNA Next generation IO Cell therapy Legend Small molecules ADCs BNT326/YL2026 (HER3) Multiple solid tumors BNT311/GEN10463 (PD-L1x4-1BB) R/R met. NSCLC, +/- pembrolizumab BNT1112 aPD(L)1-R/R melanoma, + cemiplimab BNT113 1L rel./met. HPV16+ PDL-1+ head and neck cancer, + pembrolizumab Autogene cevumeran/BNT1221 1L adv. melanoma, + pembrolizumab Autogene cevumeran/BNT1221 Adj. ctDNA+ stage II or III CRC BNT1162 1L adv. PD-L1 50% NSCLC, + cemiplimab Autogene cevumeran/BNT1221 Adj. PDAC, + atezolizumab + mFOLFIRINOX BNT316/ONC-392 (gotistobart)4 (CTLA-4) Plat.-R. ovarian cancer, + pembrolizumab **BNT323/DB-13035 (HER2) 2L+ endometrial cancer BNT316/ONC-392 (gotistobart)4 (CTLA-4) mCRPC, + radiotherapy NEW NEW NEW NEW NEW NEW NEW NEW NEW BNT411 (TLR7) Multiple solid tumors
Making Progress Towards Submissions for Regulatory Approvals in Oncology 13 1. Partnered with OncoC4; 2. Partnered with DualityBio; 3. Partnered with Genentech, member of the Roche group; 4. Partnered with Genmab; 5. Partnered with Biotheus. PD-1 =programmed cell death protein 1; HER2 = human epidermal growth factor receptor 2; HR = hormone receptor; NSCLC = non-small cell lung cancer; PDAC = pancreatic ductal adenocarcinoma; CRC = colorectal cancer, HNSCC = head and neck squamous cell carcinoma; HPV = human papillomaviruses. Plans for at least six programs in 10+ potentially pivotal trials by end of 2024 Select ongoing mid- to late-stage trials Mid- to late-stage trials planned in 2024 & beyond BNT323/DB-13032 BNT211 BNT311/GEN1046 (acasunlimab)4 Autogene cevumeran/BNT1223 BNT327/PM80025 BNT316/ONC-392 (gotistobart)1 anti-PD-1/PD-L1-experienced NSCLC BNT323/DB-13032 HR+, HER2-low met. breast cancer Autogene cevumeran/BNT1223 Adj. PDAC, + atezolizumab + mFOLFIRINOX Autogene cevumeran/BNT1223 Adj. CRC BNT113 PDL-1+, HPV16+ HNSCC, + pembrolizumab Phase 3 Phase 3 Phase 2 Phase 2 Phase 2 Phase 3 Phase 3 Phase 3 Phase 2 Phase 2 Plan to have 10+ potentially registrational trials starting in 2024 and beyond
ADC Portfolio Constructed with Thoughtful Considerations 14 1. RNAseq data from AACR Project GENIE; 2. Partnered with DualityBio; 3. The completion of the agreement with MediLink is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act. ADC = antibody-drug conjugate; MoA = mode of action; HR = hormone receptor; HER2/3 = human epidermal growth factor receptor 2/3; TROP2 = trophoblast cell-surface antigen; (N)SCLC = (non-)small cell lung cancer; BC = breast cancer; TNBC = triple-negative breast cancer; CRC = colorectal cancer; PDAC = pancreatic ductal adenocarcinoma; HNSCC = head and neck squamous cell carcinoma; EC = endometrial cancer. Target Program Stage Indications Partner Ph1/2 Ph2 Ph3 HER2 BNT323/DB-13032 HR+ HER2-low mBC DualityBio HER2-expressing mEC, 2L+ Solid tumors with HER2 expression TROP2 BNT325/DB-13052 Solid tumors DualityBio B7H3 BNT324/DB-13112 Solid tumors DualityBio HER3 BNT326/YL2023 Solid tumors MediLink3 Target NSCLC SCLC HER2+ BC HR+ BC TNBC CRC Gastric Ovarian PDAC HNSCC Prostate HER2 TROP2 B7-H3 HER3 High Medium / / Low Very low / No-expression • ADC combinations that are based on non- overlapping tumor antigens and different payload MoAs • Four clinical stage ADCs with broad, yet minimal overlapping, indication opportunities • Innovative trial designs planned to open leapfrog path • Fast-follower potential in large indications • BNT323/DB-13032 in multiple pivotal studies Expression level by indication1 Unique indication selection strategy Wider therapeutic window may enable novel combinations in earlier lines Advanced asset on path to registration
BNT323/DB-13031: A HER2 ADC with a Potentially Differentiated Profile 15 1. Partnered with DualityBio; 2. DS-8201 is an in-house produced analog of trastuzumab deruxtecan. ADC = antibody-drug conjugate; HER2 = human epidermal growth factor receptor 2; IgG1 = Immunoglobulin 1; DAR = drug antibody ratio; mAb = monoclonal antibody. Preclinical Data Lin S. et al. Abstract #252. Presented at EORTC- NCI-AACR in 2022 & data on file. BNT323/DB-1303 is a 3rd generation ADC Mode of action • Superior in vitro plasma stability in human plasma • Sustained tumor-selective drug release in tumor-bearing mice • Rapid systemic clearance in monkeys • Potent anti-tumor effect in both HER2 positive and HER2 low tumor models with a wide therapeutic window • Induces dose-dependent tumor growth inhibition and tumor regression • Toxicity studies2 in monkeys show improved toxicity profile compared to published profile of DS-82012 Stable linker and fast clearance may contribute to the improved toxicity profile of BNT323/DB-13031 Humanized anti-HER2 IgG1 mAb DAR of ~8 Cysteine residue Linker-payload • A humanized anti-HER2 IgG1 monoclonal antibody • A proprietary DNA topoisomerase I inhibitor • A maleimide tetrapeptide- based cleavable linker 1. ADC binds to antigen 2. Internalization of the ADC complex by endocytosis 3. Payload released after linker cleavage Target antigen ADC 4. Cytotoxic effect by payload in the nucleus Bystander cell Targeted Cytotoxicity Bystander killing effect A. Release of drug payload after antigen binding before internalization B. Release of drug payload into the intercellular space due to high drug membrane permeability ADC Adapted from Coleman N.et al. npj Precis. Onc. 2023
First-in-Human Trial with BNT323/DB-13031 in Patients with Advanced HER2-Expressing Solid Tumors 1. Partnered with DualityBio. HER2 = human epidermal growth factor 2; IHC = immunohistochemistry; ISH = in-situ hybridization; NGS = next-generation sequencing; HR = hormone receptor; CRC = colorectal cancer; UC = uterine carcinosarcoma, USC = uterine serous carcinoma NSCLC = non-small cell lung cancer; BC = breast cancer, RP2D = recommended phase 2 dose; ECOG = Eastern Cooperative Oncology Group; MTD = maximum tolerated dose; . 16 Phase 1/2a trial design (NCT05150691), multicenter, non-randomized, open-label Moore K. et al. Presented at ASCO 2023. Abstract #3023. Part 1: Dose escalation (n=88 patients) Part 2a: Dose expansion cohorts (n=165 patients) (HER2 IHC 3+, IHC 2+, IHC 1+ or ISH +, or HER2 amplification and mutation by NGS) Status First patient in: Jan 2022 Trial ongoing Trastuzumab-treated HER2+ (IHC3+, IHC2+/ISH positive) gastric or gastroesophageal junction adenocarcinoma, esophageal carcinoma and CRC 10.0 mg/kg 12.0 mg/kg 8.0 mg/kg 7.0 mg/kg 6.0 mg/kg 4.4 mg/kg 2.2 mg/kg Both HER2 overexpression and HER2 low (IHC3+,2+,1+ or ISH positive) endometrial carcinoma, including UC and USC HR+/HER2 Low (IHC2+ /ISH negative, or IHC1+) breast cancer HER2+ (IHC3+, IHC2+/ISH positive) breast cancer NSCLC with activating HER2 mutation HER2+ or HR+/HER2-low breast cancer with treatment failure of trastuzumab deruxtecan (HER2+ BC; HR+/HER2-low BC) Key endpoints Safety, tolerability, pharmacokinetic, preliminary anti-tumor activity at the selected MTD/RP2D Inclusion criteria Pretreated advanced or metastatic solid tumors Histologically confirmed HER2-positive or HER2- expressing cancers Previous systemic therapies ECOG PS 0-1 Adequate organ function (RP2D=8 mg/kg) RP2D/ MTD
First Clinical Data for BNT323/DB-13031 Demonstrated Antitumor Activity in Heavily Pretreated HER2-Expressing Breast Cancer Patients 17 1. Partnered with DualityBio. HER2 = human epidermal growth factor receptor 2; HR = hormone receptor; ORR = objective response rate; DCR = disease control rate; FIH = first in human; IHC = immunohistochemistry; ISH = in-situ hybridization.. BNT323/DB-13031 was well-tolerated and all adverse events were manageable Results supported the initiation of a pivotal phase 3 study evaluating BNT323/DB-13031 in HR+/HER2 low br ast c ncer ORR, % DCR, % HER2+ breast cancer (n=26) 50 96.2 HER2 low breast cancer (n=13) 38.5 84.6 Anti-tumor activity in heavily pretreated HER2-expressing breast cancer patients Phase 1/2a FIH study (NCT05150691): Clinical activity and safety Adapted from Moore K. et al. Presented at ASCO 2023. Abstract #3023. B e s t c h a n g e f ro m b a s e li n e ( % ) IS H + IS H + IS H + IS H + IS H + IS H + 3+1+ 2+HER2 IHC Status: -100 -50 0 50 100 4.4 mg/kg 7 mg/kg6 mg/kg 8 mg/kg Best response across HER2 expression levels and dose levels
Total diagnosed breast cancer patients in U.S., UK, EU4 and Japan: ~708K2-5 Potential future treatment algorithm for patients with adv./met. breast cancer BNT323/DB-13031 May Have Potential to Establish a New SoC for Chemotherapy-Naïve, HR+/HER2-Low Patients with Breast Cancer 18 1. Partnered with DualityBio; 2. American Cancer Society (ACS) 2023 Report; 3. Globocan – Cancer Tomorrow; 4. Cancer.net ASCO; 5. SEER*Stat Research Tool; 6. Putnam Expertise, KOL inputs from SMARTANALYST Syndicated Insights Report and triangulation from published literature; 7. Burstein et al., NEJM 2020; 2557-2570 8. Market Research, data on file. SoC = standard of care; ET = endocrine therapy; HR = hormone receptor; HER2 = human epidermal growth factor receptor 2; CDK4/6 = cyclin-dependent kinase 4/6; 1/2/3L = first/second/third line; mBC = metastatic breast cancer; EU4 = includes Germany, France, Italy and Spain. ~60% of patients with met. breast cancer progress to 2L8 HER2-directed drug candidates in HR+/HER2-low mBC chemotherapy naïve patients: ET therapy/chemotherapy 1L 2L+ Advanced/unresectable, recurrent HR+/HER2-low breast cancer (~95K) Subject to regulatory approval Relevant patient population: HR+/HER2-negative (70%6 of total breast cancer patients) HR+/HER2-low (60%67of HR+/HER2-neg breast cancer patients) ET therapy/ chemotherapy or Trastuzumab-Deruxtecan3L+ Endocrine therapy (ET) +/- CDK4/6 inhibitor (~90%) Chemotherapyor BNT323/DB-13031 Trastuzumab-Deruxtecan
Data Supporting Efficacy of BNT323/DB-13031 Facilitates Path to a Potential Registration in HER2-Expressing Endometrial Cancer Patients 19 1. Partnered with DualityBio. HER2 = human epidermal growth factor receptor 2; FIH = first in human; IHC = immune histo chemistry test; ORR = objective response rate; DCR = disease control rate; ISH = In situ hybridization. Phase 1/2a FIH study (NCT05150691): Clinical Efficacy Moore K. et al. Presented at ESGO 2023. Abstract # 430 Responsea Dose Escalation Dose Expansion Total (n=17)b 7 mg/kg (n=4)b 8 mg/kg (n=4)b 8 mg/kg (n=9)b Unconfirmed ORR, n (%) 2 (50.0) 4 (100) 4 (44.4) 10 (58.8) Confirmed ORR, n (%) 1 (25.0) 3 (75.0) 0 4 (23.5) Pending confirmation ORR, n (%) 1 (25.0) 1 (25.0) 4 (44.4) 6 (35.3) Unconfirmed DCR, n (%) 4 (100) 4 (100) 8 (88.9) 16 (94.1) a By investigator. b Response-evaluable subjects, which includes subjects with ≥1 postbaseline overall response. B e s t c h a n g e f ro m b a s e li n e ( % ) ISH+ ISH+ ISH+ ISH+ ISH+ # Subject 30 0 -30 -60 -90 Dose level 7 mg/kg 8 mg/kg 1+ 2+ 3+HER2 IHC status • HER2 tumor expression of IHC 1, 2 and 3+: 31%, 41% and 25%, respectively • Patients received median 2 lines of prior treatment for the metastatic disease • ~60% of patients had received prior immunotherapy, ~38% prior anti-HER2 antibody • Clinical response observed across different HER2-expression levels, including IHC 1+ tumors
Potential future treatment algorithm for patients with adv./met. endometrial cancer3 BNT323/DB-13031 Offers the Potential to Establish a New SoC for Patients with HER2-Expressing Endometrial Cancer 20 1. Partnered with Duality Bio; 2. CancerMPact® Treatment Architecture Endometrial; U.S. and EU5 v1.1; 3. NCCN guidelines® Version 1.2024; 4. Makker V et al. NEJM. 2022; 5. Keytruda PI: https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf. SoC = standard of care;; HER2 = human epidermal growth factor receptor 2; 1L = first line; 2L+ = second line and beyond; EU4 = includes Germany, France, Italy and Spain; MSS/MSI = microsatellite in/stability; MMR = mismatch repair; PD-1 = programmed cell death protein 1; EC = endometrial cancer; * Dostarlimab approved in patients with MSI-H/dMMR tumors. NCCN guidelines recommend dostarlimab or pembrolizumab + chemotherapy irrespective of MMR status; ** pMMR tumors: pembrolizumab+lenvatinib, MSI-H/dMMR tumors pembroliumab or dostarlimab monotherapy; ***NCCN guidelines recommend Trastuzumab Deruxtecan for HER2-positive tumors (IHC 3+ or 2+). Chemotherapy combo (+/- bevacizumab) ~40 % progress and receive 2L therapy1 ICI + chemotherapy* Trastuzumab + chemotherapy (for HER2+ USC, carcinosarcoma) BNT323/ DB-1303 Anti-PD-1 +/- Lenvatinib** Chemotherapy (+/- bevacizumab) 1L 2L+ Advanced/unresectable, recurrent Stage IV (~50K) Subject to regulatory approval Relevant patient population: or or oror Total diagnosed endometrial cancer patients in US, UK, EU4 and Japan: ~130K2 MSS/MMR proficient MSI-H/MMR deficient HER2-positive ORR: 30% mPFS: 6.6 mo mOS: 17.4 mo4 ORR: 15%; mPFS: 3.8 mo; mOS: 12.0 mo5 Trastuzumab- Deruxtecan*** HER2-directed drug candidates in mEC:
Product candidate BNT323/ DB-13031 BNT316/ ONC-392 (gotistobart)2 BNT327/ PM80023 BNT211 BNT311/ GEN1046 (acasunlimab)4 Target HER2 CTLA-4 VEGF-A x PDL-1 VHH CLDN6 PD-L1 x 4-1BB First Wave of Potential Oncology Launches From 2026 Onwards Could Include: 21 1. Partnered with DualityBio; 2. Partnered with OncoC4; 3. Partnered with Biotheus; 4.. Partnered with Genmab MoA = mode of action; HER2 = human epidermal growth factor 2; CTLA-4 = cytotoxic T-lymphocyte-associated protein 4; PD1 = programmed cell death protein 1; CLDN6 = claudin 6. We believe we have multiple shots on goal, and that our in-licensed assets are starting to contribute to value creation and towards de-risking our pipeline Diverse MoAs Validated & new targets Mix of partnered and proprietary programs
3 Financial Results Jens Holstein, Chief Financial Officer
FY 2023 Key Financial Highlights1 23 1. Financial information is prepared and presented in Euros and numbers are rounded to millions and billions of Euros in accordance with standard commercial practice. 2. Consists of cash and cash equivalents of €11,663.7 million and security investments of €5,989.7 million, as of December 31, 2023. Profit before tax €3.83 €1.2bn €3.8 bn €17.7 bn Total revenues Diluted EPS Total cash plus security investments2
FY 2023 Revenues and Cash plus Security Dynamics 24 13,9 17,72 YE 2022 YE 2023 +27% FY 2023 revenues reduced by significant write-downs Cash plus security investments grew in 20233 4,7 3,8 0,9 FY 2023 revenues without reflection of write-downs4 FY 2023 write-downs FY 2023 revenues (in billions €)1 1. Numbers have been rounded, numbers presented may not add up precisely to the totals and may have been adjusted in the table context. 2. Consists of cash and cash equivalents of €11,663.7 million and security investments of €5,989.7 million, as of December 31, 2023. 3. Contractual settlement of the gross profit share has a temporal offset of more than one calendar quarter and even has an additional time lag between the recognition of revenues and the payment receipt for gross profit of subsidiaries outside the United States. 4. Inventory write-downs and other charges identified on the collaboration partner Pfizer’s side, jointly referred to as write-downs, are reducing Pfizer’s gross profit, hence BioNTech’s revenues. (in billions €)1
Q4 and FY 2023 Financial Results 25 1. Numbers have been rounded, numbers presented may not add up precisely to the totals and may have been adjusted in the table context. Presentation of the consolidated statements of profit or loss has been condensed. 2. BioNTech’s profit share is estimated based on preliminary data shared between Pfizer and BioNTech as further described in the Annual Report on Form 20-F for the year ended December 31, 2023, filed on March 20, 2024. Any changes in the estimated share of the collaboration partner's gross profit will be recognized prospectively. 3. Adjustments to prior-year figures relate to costs for external legal advice in connection with certain legal litigations from general and administrative expenses to other operating expense to reflect changes in the internal reporting also in the external reporting. Three months ended December 31 Years ended December 31 (in millions €, except per share data)1 2023 2022 2023 2022 Commercial revenues2 1,478.9 4,271.3 3,815.5 17,194.6 Research & development revenues 0.1 7.0 3.5 116.0 Total revenues 1,479.0 4,278.3 3,819.0 17,310.6 Cost of sales (179,1) (183.5) (599.8) (2,995.0) Research and development expenses (577.8) (509.8) (1,783.1) (1,537.0) Sales and marketing expenses (18.0) (14.6) (62.7) (59.5) General and administrative expenses (124.3) (119.9) (495.0) (481.7) Other operating income less expenses3 (53.6) (157.6) (188.0) 405.3 Operating income 526.2 3,292.9 690.4 12,642.7 Finance income less expenses 137.0 (120.3) 495.7 311.4 Profit before tax 663.2 3,172.6 1,186.1 12,954.1 Income taxes (205.3) (893.9) (255.8) (3,519.7) Profit for the period 457.9 2,278.7 930.3 9,434.4 Earnings per share Basic profit for the period per share 1.91 9.38 3.87 38.78 Diluted profit for the period per share 1.90 9.26 3.83 37.77
FY 2023 Guidance vs. Actuals1 26 FY 2023 COVID-19 vaccine revenues BioNTech COVID-19 vaccine revenues ~ €4 bn €3.8 bn FY 2023 expenses and capex R&D expenses2 €1,800 – 2,000 m €1,783 m SG&A expenses3 €600 – 650 m €558 m Capital expenditure for operating activities €200 – 300 m €276 m FY 2023 tax assumptions BioNTech Group estimated annual cash effective income tax rate ~ 21% 21.6% Updated Guidance Nov 2023 FY 2023 Actuals 1. Numbers reflect current base case projections and are calculated based on constant currency rates. Excluding external risks that are not yet known and/or quantifiable, including, but not limited to, the effects of ongoing and/or future legal disputes or related activity. 2. Numbers include effects identified from additional in-licensing arrangements, collaborations or potential M&A transactions to the extent disclosed and are subject to update due to future developments. 3. Excluding costs for external legal advice in connection with certain legal litigations recorded in other operating expense. Guidance does not include and may be impacted by potential payments resulting from the outcomes of ongoing or future legal disputes or related activity, such as judgments or settlements.
Revenue guidance considerations: Top-line sensitivity mainly dependent on the following factors • Vaccination rates and price levels in markets where significant Comirnaty sales are expected • Inventory write-downs • Anticipated revenues related to service businesses, including InstaDeep, JPT Peptide Technologies, IMFS and from the German pandemic preparedness agreement 2024 Financial Year Guidance1 27 1. Excluding external risks that are not yet known and/or quantifiable, including, but not limited to, the effects of ongoing and/or future legal disputes or related activity. 2. Numbers include effects identified from additional in-licensing arrangements, collaborations or potential M&A transactions to the extent disclosed and are subject to update due to future developments. 3. Anticipated expenses related to external legal advice in connection with legal litigations is not reflected in SG&A but in other operating expenses for the 2024 financial year. Guidance does not include and may be impacted by potential payments resulting from the outcomes of ongoing or future legal disputes or related activity, such as judgments or settlements. 4. The Company does not expect to report a positive net income figure for the 2024 financial year and expects the majority of our 2024 global revenues for Comirnaty to be recorded in the second half of the year. IMFS = BioNTech’s Innovative Manufacturing Services FY 2024 revenues Total revenues €2,500 – €3,100 m FY 2024 expenses, operating income and capex4 R&D expenses2 €2,400 – €2,600 m SG&A expenses3 €700 – €800 m Capital expenditure for operating activities €400 – €500 m FY 2024 Guidance
COVID-19 Vaccine Business – major value contributor Innovative Oncology Pipeline – potential future value driver Profitable COVID-19 Vaccine Business supports Investment in Growth Drivers 28 : FY 2023 • Revenue of €3.8 bn • Gross Profit of €3.2 bn • COVID-19 associated R&D costs ~ €0.3 bn • S&M costs < €0.05 bn • COVID-19 vaccine business with lean cost structure expected to generate positive cash flows going forward • Aiming for 10+ potentially registrational trials ongoing by the end of 2024 • First potential oncology launch estimated for 2026 • Diversified clinical pipeline offers multiple potential growth opportunities for the years to come COVID-19 vaccine franchise and innovative oncology pipeline driving long-term value creation
4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
5 active non-COVID ID clinical programs 10+ potentially registrational trials expected by YE 2024 Cash position Respiratory vaccine franchise Oncology pipeline Infectious diseases pipeline Strategic Vision for 2030 30 1. Consists of €11,663.7 million cash and cash equivalents and €5,989.7 million security investments, as of December 31, 2023. YE = year end; ID = infectious disease; €17.7 bn cash1 Market-leading COVID-19 vaccine Expanding late-stage pipeline Early-stage pipeline Maintain strong balance sheet Multi-vaccine portfolio Multiple commercial products and additional late-stage candidates First approved products and late-stage pipeline YE 2023 2030 Vision Key value drivers Long-term growth from diversified, cashflow-generating multi-product portfolio Cashflow generating
Investing in Our Oncology Growth Through 2030 31 Impact Yearly oncology launches planned from 2026 onwards Goal of 10 indication approvals in oncology by 2030 Aiming for 10+ potentially registrational trials by end of 2024 Multiple clinical updates planned for 2024 2024Mid- and late-stage programs BNT323/DB-13031 BNT316/ONC-392 (gotistobart)2 BNT311/GEN1046 (acasunlimab)3 BNT327/PM80024 autogene cevumeran/BNT1225 BNT113 BNT211
Save the date Annual General Meeting May 17, 2024 Innovation Series: Digital & AI October 1, 2024 Innovation Series November 14, 2024
Thank you
Appendix
Advancing our Pipeline: Select Data Milestones in 2024 35 1. Partnered with Genmab; 2. Partnered with OncoC4; 3. Partnered with DualityBio; 4. Partnered with Biotheus; 5. Partnered with Pfizer. NSCLC = non-small cell lung cancer, R/R = relapsed/refractors. Program Indication Targeted Milestone Oncology BNT311/GEN1046 (acasunlimab)1 R/R met. NSCLC, +/- pembrolizumab Phase 2 data BNT312/GEN10421 Multiple solid tumors Ph1/2 expansion cohort data BNT316/ONC-392 (gotistobart)2 Multiple solid tumors Ph1/2 expansion cohort data BNT323/DB-13033 Multiple solid tumors Ph1/2 expansion cohort data BNT325/DB-13053 Multiple solid tumors Ph1/2 data BNT327/PM80024 Multiple solid tumors Phase 2 data Infectious Disease BNT162b25 COVID-19, Omicron XBB.1.5 monovalent vaccine Phase 2/3 data BNT1675 Shingles Phase 1 trial update