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 MAY 2023
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 May 8, 2023, BioNTech SE (the “Company”) issued a press release announcing its first quarter 2023 financial results and corporate update and details of a conference call to be held at 8:00 am EDT on May 8, 2023 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: May 8, 2023
EXHIBIT INDEX
| Exhibit | Description of Exhibit | ||||
| 99.1 | |||||
| 99.2 | |||||
Exhibit 99.1
BioNTech Announces First Quarter 2023 Financial Results and Corporate Update
•COVID-19 vaccine franchise focused on vaccine adaptation readiness ahead of the fall season and advancing next generation vaccine candidates and combinations
•BioNTech and partner OncoC4 plan to start a Phase 3 clinical trial evaluating anti-CTLA-4 antibody BNT316 (ONC-392) as monotherapy in NSCLC patients who progress after PD-1/PD-L1 treatment
•Added new class of precision therapeutics to clinical-stage oncology portfolio, with next-generation Antibody-Drug Conjugate (ADC) candidates
•Presenting clinical data on antibody candidate BNT316 (ONC-392), ADC candidate BNT323 (DB-1303) and CAR-T candidate BNT211 at the 2023 American Society of Clinical Oncology Annual Meeting
•Broadened clinical-stage infectious disease vaccine pipeline with the start of a First-in-Human clinical trial for the first mRNA-based Tuberculosis vaccine candidates
•Reiterates BioNTech COVID-19 vaccine revenue guidance of approximately €5 billion in 2023
•First quarter1 revenues of €1.3 billion2, net profit of €0.5 billion and fully diluted earnings per share of €2.05 ($2.203)
Conference call and webcast scheduled for May 8, 2023, at 8:00 am EDT (2:00 pm CEST)
MAINZ, Germany, May 8, 2023 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or the “Company”) today reported financial results for the three months ended March 31, 2023, and provided an update on its corporate progress.
“In the first quarter of 2023, we expanded our toolkit of cutting-edge technologies to new modalities and added a novel immune checkpoint inhibitor candidate targeting CTLA-4 and two investigational antibody-drug conjugates to our arsenal against cancer. These programs are strategically aligned with our vision to provide meaningful therapeutic benefits for patients with solid tumors along the entire treatment journey,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “We are taking significant steps in this direction as we prepare to initiate our first Phase 3 clinical trial in oncology for the novel anti-CTLA-4 antibody in NSCLC patients who have progressed after PD-1/PD-L1 treatment, a patient population with high medical need. We are also making progress in advancing our next generation COVID-19 vaccine candidate while we stand prepared for variant adaptation in case of public health need. For the remainder of 2023, we are focused on advancing our disruptive platforms against solid tumors and accelerating clinical programs in infectious diseases of high global need.”
Financial Review for the First Quarter 2023
| in millions €, except per share data | First Quarter 2023 | First Quarter 2022 | ||||||
Total Revenues2 | 1,277.0 | 6,374.6 | ||||||
| Net Profit | 502.2 | 3,698.8 | ||||||
Diluted Earnings per Share | 2.05 | 14.24 | ||||||
Total revenues reported were €1,277.0 million2 for the three months ended March 31, 2023, compared to €6,374.6 million2 for the comparative prior year period. The change was mainly due to lower commercial revenues from the supply and sales of the Company’s COVID-19 vaccines worldwide.
Cost of sales were €96.0 million for the three months ended March 31, 2023, compared to €1,294.1 million for the comparative prior year period. The change was mainly due to decreasing sales from BioNTech’s COVID-19 vaccine revenues.
Research and development expenses were €334.0 million for the three months ended March 31, 2023, compared to €285.8 million for the comparative prior year period. The change was mainly due to higher expenses incurred from progressing the clinical studies for pipeline candidates. The increase was further driven by an increased headcount.
General and administrative expenses were €119.4 million for the three months ended March 31, 2023, compared to €90.8 million for the comparative prior year period. The change was mainly due to increased expenses for IT, purchased external services, as well as an increase in headcount.
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Income taxes were accrued in an amount of €205.5 million of tax expenses for the three months ended March 31, 2023, compared to €1,319.3 million of tax expenses for the comparative prior year period. The derived annual effective income tax rate for the three months ended March 31, 2023, was 29.0% which is expected to decrease over the 2023 financial year to be in line with BioNTech’s guidance.
Net profit was €502.2 million for the three months ended March 31, 2023, compared to €3,698.8 million for the comparative prior year period.
Cash and cash equivalents as well as security investments were €12,143.9 million and €671.9 million, respectively, as of March 31, 2023. Subsequent to the end of the reporting period, the payment settling BioNTech’s gross profit share for the fourth quarter of 2022 (as defined by the contract with Pfizer, Inc. (“Pfizer”)) in the amount of €3,961.3 million was received from our collaboration partner as of April 14, 2023. The contractual settlement of the gross profit share under the COVID-19 vaccine program collaboration with Pfizer has a temporal offset of more than one calendar quarter. As Pfizer’s fiscal quarter for subsidiaries outside the United States differs from BioNTech’s financial reporting cycle, it creates an additional time lag between the recognition of revenues and the payment receipt.
Shares outstanding as of March 31, 2023 were 240,990,499.
Cash outflows and share consideration in connection with the planned acquisition of InstaDeep Ltd. (“InstaDeep”) and the upfront payments of the collaboration and license agreements with OncoC4, Inc. (“OncoC4”) and Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”) of approximately €0.8 billion are expected (subject to change and excluding future potential earn-out and milestone payments).
“In the first quarter of 2023, our financial performance has been fully in line with our expectations and we executed according to our capital allocation priorities by growing and advancing our clinical-stage pipeline, announcing multiple significant business development transactions and continuing to pursue our share repurchase program,” said Jens Holstein, CFO of BioNTech. “For the remainder of 2023, we remain focused on fulfilling our goals and continuing to provide value to our patients and shareholders.”
Outlook for the 2023 Financial Year
The Company reiterates its prior financial year outlook:
BioNTech COVID-19 Vaccine Revenues for the 2023 Financial Year:
Estimated BioNTech COVID-19 vaccine revenues for the full 2023 financial year | ~ €5 billion | ||||
This revenue estimate reflects expected revenues related to BioNTech’s share of gross profit from COVID-19 vaccine sales in the collaboration partners’ territories, from direct COVID-19 vaccine sales to customers in BioNTech’s territory and expected revenues generated from products manufactured by BioNTech and sold to collaboration partners, which may be influenced by costs such as inventory write-offs once materialized and shared with the collaboration partner Pfizer.
Revenue guidance is based on various assumptions, including, but not limited to, the expected transition from an advanced purchase agreement environment to commercial market ordering starting in some geographies and an expected regulatory recommendation to adapt the COVID-19 vaccines to address newly circulating variants or sublineages of SARS-CoV-2. The estimated BioNTech COVID-19 vaccine revenues reflect expected deliveries under existing or committed supply contracts and anticipated sales through traditional commercial orders. A re-negotiation of the existing supply contract with the European Commission is ongoing, with the potential for a rephasing of deliveries of doses across multiple years and/or a volume reduction. While a vaccine adaptation is expected to lead to increased demand, fewer primary vaccinations and lowered population-wide levels of boosting are anticipated. Seasonal demand is assumed, moving expected revenue generation significantly to the second half of the year 2023.
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Planned 2023 Financial Year Expenses and Capex4:
R&D expenses5 | €2,400 million - €2,600 million | ||||
SG&A expenses | €650 million - €750 million | ||||
Capital expenditures for operating activities6 | €500 million - €600 million | ||||
Estimated 2023 Financial Year Tax Assumptions:
| BioNTech Group estimated annual cash effective income tax rate | ~ 27% | ||||
Operational Review and Pipeline Update for the First Quarter 2023 and Key Post Period-End Events
Oncology Pipeline
BNT316 (ONC-392) is an anti-CTLA-4 monoclonal antibody candidate being developed in collaboration with OncoC4. BNT316 (ONC-392) offers a potentially differentiated safety profile that may allow for higher dosing and longer duration of treatment both as a monotherapy and in combination with other therapies.
•BioNTech and OncoC4 plan to start a Phase 3 clinical trial to evaluate BNT316 (ONC-392) as monotherapy in non-small cell lung cancer (NSCLC) patients who progress on anti-PD-1/PD-L1 antibody-based therapy in 2023.
•BioNTech and OncoC4 plan to present data from an expansion cohort evaluating BNT316 (ONC-392) as monotherapy in NSCLC patients as part of the ongoing Phase 1/2 clinical trial at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA, from June 2-6, 2023.
BNT323 (DB-1303) is a HER2-targeted antibody-drug conjugate (ADC) candidate, being developed in collaboration with DualityBio.
•BNT323 (DB-1303) is currently being evaluated in a Phase 1/2 clinical trial in patients with advanced/unresectable, recurrent, or metastatic HER2-expressing solid tumors. BioNTech and DualityBio expect a data update from the ongoing trial at the 2023 ASCO Annual Meeting.
•In January, BNT323 (DB-1303) received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with HER2-overexpressing advanced, recurrent, or metastatic endometrial carcinoma who have progressed on or after standard systemic treatment.
Autogene cevumeran (BNT122) is an mRNA cancer vaccine candidate based on an individualized neoantigen-specific immunotherapy (iNeST) approach being developed in collaboration with Genentech, a member of the Roche Group.
•A Phase 2 clinical trial of BNT122 in the adjuvant setting in patients with pancreatic ductal adenocarcinoma (PDAC) is planned to open in 2023.
BNT211 is an autologous CLDN6-targeting chimeric antigen receptor (CAR) T cell therapy that is being tested alone and in combination with a CAR-T cell Amplifying RNA Vaccine, or CARVac, encoding CLDN6.
•BioNTech expects a data update from the ongoing Phase 1/2 dose escalation and expansion clinical trial, in patients with CLDN6-positive relapsed or refractory advanced solid tumors at the 2023 ASCO Annual Meeting.
Infectious Diseases Pipeline
Next-generation COVID-19 Vaccine Program BNT162b2 + BNT162b4
•In April, BioNTech reported preclinical data on BNT162b4, the vaccine component encoding conserved non-spike antigen derived T cell epitopes, alone and in combination with BNT162b2, encoding the full spike protein. In the preclinical study, the candidate protected from severe COVID-19 disease and enhanced viral clearance. The findings are in press in the peer-reviewed journal Cell (Arieta C. et al. The T-cell-directed vaccine BNT162b4 encoding
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conserved non-spike antigens protects animals from severe SARS-CoV-2 infection, Cell (2023), doi: https://doi.org/10.1016/j.cell.2023.04.007.).
•A Phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of BNT162b4 in combination with BNT162b2 is ongoing.
Tuberculosis Vaccine Program – BNT164
•In April, BioNTech initiated a randomized, controlled, dose-finding Phase 1 clinical trial of BNT164 in partnership with the Bill and Melinda Gates Foundation. The clinical trial will evaluate the safety, reactogenicity, and immunogenicity of mRNA vaccine candidates against Tuberculosis.
Shingles Vaccine Program – BNT167
•In February, BioNTech and Pfizer initiated a multicenter, randomized, controlled, dose-selection Phase 1/2 clinical trial of BNT167, the companies’ mRNA vaccine candidate against shingles (also known as herpes zoster). The clinical trial will evaluate the safety, tolerability, and immunogenicity of mRNA vaccine candidates against shingles.
Corporate Update for the First Quarter 2023 and Key Post Period-End Events
•In January, BioNTech entered into an agreement to acquire its long-standing strategic collaboration partner InstaDeep, enabling the creation of a fully integrated, enterprise-wide capability that leverages artificial intelligence and machine learning technologies across BioNTech’s therapeutic platforms and operations. The transaction is subject to customary closing conditions and regulatory approvals.
•In January, BioNTech signed a Memorandum of Understanding with the Government of the United Kingdom to establish a multi-year collaboration focused on three strategic pillars: cancer immunotherapies based on mRNA or other drug classes, infectious disease vaccines, and investments into expanding BioNTech’s footprint in the UK as one of the Company’s key markets. The goal of the collaboration is to provide personalized cancer therapies for up to 10,000 patients by the end of 2030, either in clinical trials or as authorized treatments.
•In February, BioNTech completed construction of the Company’s first proprietary plasmid DNA manufacturing facility. The plasmid DNA produced at this state-of-the-art facility in Marburg, Germany is planned to be used globally and serve as the basis for the manufacturing of mRNA- and cell-based products on a clinical or commercial scale.
•In March, BioNTech announced the establishment of an interdisciplinary mRNA Excellence Center to conduct research jointly with scientists from Weizmann Institute of Science in Israel. The Company’s mRNA Excellence Center is expected to provide space for approximately 60 researchers to facilitate collaboration across various fields, including life science, computer science, mathematics, physics, and chemistry.
•In March, BioNTech provided an update on its plans to establish scalable mRNA vaccine production in Africa. The Company announced that six ISO-sized shipping containers for the first BioNTainer, a turnkey manufacturing solution designed to enable scalable mRNA vaccine production in bulk, arrived in Kigali, Rwanda.
•In March, BioNTech entered into an exclusive worldwide licensing and collaboration agreement with OncoC4 to co-develop and commercialize BNT316 (ONC-392), an anti-CTLA-4 monoclonal antibody candidate as monotherapy or combination therapy in various cancer indications.
•In March, BioNTech entered into a new share repurchase program pursuant to which the Company may purchase American Depositary Shares, each representing one ordinary share of the Company, in the amount of up to $0.5 billion during the remainder of 2023.
•In April, BioNTech entered into exclusive license and collaboration agreements with DualityBio to develop, manufacture and commercialize two investigational topoisomerase-1 inhibitor-based ADC assets, BNT323 (DB-1303) and BNT324 (DB-1311).
Environmental, Social, and Governance (ESG)
BioNTech recognizes its responsibility as a corporate citizen and is committed to supporting its local communities and beyond through donations, sponsorships and volunteer activities. In response to the
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earthquakes that hit Türkiye and Syria in February, BioNTech contributed to the humanitarian aid in both countries by donating €500,000 to the nonprofit organization ‘Aktionsbündnis Katastrophenhilfe’ (Action Alliance for Disaster Relief). For humanitarian aid in Ukraine, the Company donated €500,000 to the refugee relief ‘UNO-Flüchtlingshilfe’ – the partner of UN Refugee Agency (UNHCR) in Germany.
On March 27, 2023, BioNTech published its third ESG report (Sustainability Report 2022). The report is available in the Investor Relations section of BioNTech's website.
Upcoming Investor and Analyst Events
•The Annual General Meeting is scheduled for May 25, 2023.
•BioNTech plans to host an Innovation Series Day on November 7, 2023.
Endnotes
The full interim unaudited condensed consolidated financial statements can be found in BioNTech’s Report on Form 6-K, filed today with the SEC and available at https://www.sec.gov.
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 BioNTech’s profit share is estimated based on preliminary data shared between Pfizer and BioNTech as further described in the Annual Report. Any changes in the estimated share of the collaboration partner’s gross profit will be recognized prospectively.
3 Calculated applying the average foreign exchange rate for the three months ended March 31, 2023, as published by the German Central Bank (Deutsche Bundesbank).
4 Numbers reflect current base case projections and are calculated based on constant currency rates.
5 Numbers include effects identified from additional collaborations or potential M&A transactions to the extent disclosed and will be updated as needed.
6 Numbers exclude potential effects caused by or driven from collaborations or M&A transactions.
Conference Call and Webcast Information
BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, May 8, 2023 at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the first quarter of 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.
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 Investor Relations 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 next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company 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 T cells, bispecific immune checkpoint modulators, targeted cancer antibodies and 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 pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer.
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:
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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 and completion of studies or trials and related preparatory work and the availability of results; the status and potential outcome of re-negotiations of the existing supply contract with the European Commission; the timing and expected impact of the Company’s planned acquisition of InstaDeep Ltd. and collaboration and licensing agreements with OncoC4, Inc., Duality Biologics (Suzhou) Co. Ltd. and others; the development of sustainable vaccine production and supply solutions, including BioNTainers, 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 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. 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 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 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 6-K for the period ended March 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
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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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Interim Consolidated Statements of Profit or Loss
Three months ended March 31, | ||||||||||||||
| 2023 | 2022 | |||||||||||||
| (in millions €, except per share data) | (unaudited) | (unaudited) | ||||||||||||
| Revenues | ||||||||||||||
| Commercial revenues | 1,276.5 | 6,362.2 | ||||||||||||
| Research & development revenues | 0,5 | 12.4 | ||||||||||||
| Total revenues | 1,277.0 | 6,374.6 | ||||||||||||
| Cost of sales | (96.0) | (1,294.1) | ||||||||||||
| Research and development expenses | (334.0) | (285.8) | ||||||||||||
| Sales and marketing expenses | (12.2) | (14.3) | ||||||||||||
| General and administrative expenses | (119.4) | (90.8) | ||||||||||||
| Other operating expenses | (118.1) | (71.6) | ||||||||||||
| Other operating income | 57.1 | 134.7 | ||||||||||||
| Operating income | 654.4 | 4,752.7 | ||||||||||||
| Finance income | 82.3 | 272.1 | ||||||||||||
| Finance expenses | (29.0) | (6.7) | ||||||||||||
| Profit before tax | 707.7 | 5,018.1 | ||||||||||||
| Income taxes | (205.5) | (1,319.3) | ||||||||||||
| Profit for the period | 502.2 | 3,698.8 | ||||||||||||
| Earnings per share | ||||||||||||||
| Basic profit for the period per share | 2.07 | 15.13 | ||||||||||||
| Diluted profit for the period per share | 2.05 | 14.24 | ||||||||||||
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Interim Consolidated Statements of Financial Position
| March 31, | December 31, | |||||||||||||
| (in millions €) | 2023 | 2022 | ||||||||||||
| Assets | (unaudited) | |||||||||||||
| Non-current assets | ||||||||||||||
| Intangible assets | 378.6 | 219.7 | ||||||||||||
| Property, plant and equipment | 639.2 | 609.2 | ||||||||||||
| Right-of-use assets | 208.4 | 211.9 | ||||||||||||
| Other financial assets | 516.8 | 80.2 | ||||||||||||
| Other non-financial assets | 4.4 | 6.5 | ||||||||||||
| Deferred tax assets | 245.5 | 229.6 | ||||||||||||
| Total non-current assets | 1,992.9 | 1,357.1 | ||||||||||||
| Current assets | ||||||||||||||
| Inventories | 424.1 | 439.6 | ||||||||||||
| Trade and other receivables | 6,450.5 | 7,145.6 | ||||||||||||
| Contract assets | 5.7 | — | ||||||||||||
| Other financial assets | 358.0 | 189.4 | ||||||||||||
| Other non-financial assets | 171.3 | 271.9 | ||||||||||||
| Income tax assets | 532.6 | 0.4 | ||||||||||||
| Cash and cash equivalents | 12,143.9 | 13,875.1 | ||||||||||||
| Total current assets | 20,086.1 | 21,922.0 | ||||||||||||
| Total assets | 22,079.0 | 23,279.1 | ||||||||||||
| Equity and liabilities | ||||||||||||||
| Equity | ||||||||||||||
| Share capital | 248.6 | 248.6 | ||||||||||||
| Capital reserve | 1,547.9 | 1,828.2 | ||||||||||||
| Treasury shares | (7.6) | (5.3) | ||||||||||||
| Retained earnings | 19,335.2 | 18,833.0 | ||||||||||||
| Other reserves | (858.8) | (848.9) | ||||||||||||
| Total equity | 20,265.3 | 20,055.6 | ||||||||||||
| Non-current liabilities | ||||||||||||||
| Lease liabilities, loans and borrowings | 172.4 | 176.2 | ||||||||||||
| Other financial liabilities | 6.1 | 6.1 | ||||||||||||
| Income tax liabilities | 10.8 | 10.4 | ||||||||||||
| Provisions | 8.6 | 8.6 | ||||||||||||
| Contract liabilities | 45.6 | 48.4 | ||||||||||||
| Other non-financial liabilities | 14.0 | 17.0 | ||||||||||||
| Deferred tax liabilities | 5.3 | 6.2 | ||||||||||||
| Total non-current liabilities | 262.8 | 272.9 | ||||||||||||
| Current liabilities | ||||||||||||||
| Lease liabilities, loans and borrowings | 37.4 | 36.0 | ||||||||||||
| Trade payables | 29.9 | 204.1 | ||||||||||||
| Other financial liabilities | 435.9 | 785.1 | ||||||||||||
| Refund liabilities | 80.2 | 24.4 | ||||||||||||
| Income tax liabilities | 526.3 | 595.9 | ||||||||||||
| Provisions | 320.4 | 367.2 | ||||||||||||
| Contract liabilities | 22.0 | 77.1 | ||||||||||||
| Other non-financial liabilities | 98.8 | 860.8 | ||||||||||||
| Total current liabilities | 1,550.9 | 2,950.6 | ||||||||||||
| Total liabilities | 1,813.7 | 3,223.5 | ||||||||||||
| Total equity and liabilities | 22,079.0 | 23,279.1 | ||||||||||||
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Interim Consolidated Statements of Cash Flows
Three months ended March 31, | |||||||||||
| 2023 | 2022 | ||||||||||
| (in millions €) | (unaudited) | (unaudited) | |||||||||
| Operating activities | |||||||||||
| Profit for the period | 502.2 | 3,698.8 | |||||||||
| Income taxes | 205.5 | 1,319.3 | |||||||||
| Profit before tax | 707.7 | 5,018.1 | |||||||||
| Adjustments to reconcile profit before tax to net cash flows: | |||||||||||
| Depreciation and amortization of property, plant, equipment, intangible assets and right-of-use assets | 31.4 | 27.6 | |||||||||
| Share-based payment expenses | 8.6 | 11.2 | |||||||||
| Net foreign exchange differences | 53.1 | 6.1 | |||||||||
| Loss on disposal of property, plant and equipment | 0.2 | — | |||||||||
| Finance income excluding foreign exchange differences | (82.3) | (217.3) | |||||||||
| Finance expense excluding foreign exchange differences | 1.2 | 6.7 | |||||||||
| Movements in government grants | (3.0) | — | |||||||||
| Unrealized net (gain) / loss on derivative instruments at fair value through profit or loss | 76.2 | (1.9) | |||||||||
| Working capital adjustments: | |||||||||||
| Decrease / (increase) in trade and other receivables, contract assets and other assets | 893.8 | (403.5) | |||||||||
| Decrease in inventories | 15.5 | 43.2 | |||||||||
| (Decrease) / increase in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions | (861.6) | 857.5 | |||||||||
| Interest received | 53.6 | 0.7 | |||||||||
| Interest paid | (1.2) | (6.4) | |||||||||
| Income tax paid | (844.9) | (1,290.0) | |||||||||
| Share-based payments | (725.7) | (1.8) | |||||||||
| Net cash flows from / (used in) operating activities | (677.4) | 4,050.2 | |||||||||
| Investing activities | |||||||||||
| Purchase of property, plant and equipment | (45.2) | (44.1) | |||||||||
| Purchase of intangible assets and right-of-use assets | (9.6) | (16.7) | |||||||||
| Investment in other financial assets | (680.6) | (27.0) | |||||||||
| Proceeds from maturity of other financial assets | — | 375.2 | |||||||||
| Net cash flows from / (used in) investing activities | (735.4) | 287.4 | |||||||||
| Financing activities | |||||||||||
| Proceeds from issuance of share capital and treasury shares, net of costs | — | 110.5 | |||||||||
| Repayment of loans and borrowings | — | (18.8) | |||||||||
| Payments related to lease liabilities | (9.3) | (11.4) | |||||||||
| Share repurchase program | (282.0) | — | |||||||||
| Net cash flows from / (used in) financing activities | (291.3) | 80.3 | |||||||||
| Net increase / (decrease) in cash and cash equivalents | (1,704.1) | 4.417,9 | |||||||||
| Change in cash and cash equivalents resulting from exchange rate differences | (27.1) | 53,5 | |||||||||
| Cash and cash equivalents at the beginning of the period | 13,875.1 | 1.692,7 | |||||||||
| Cash and cash equivalents as of March 31 | 12,143.9 | 6.164,1 | |||||||||
10
1st Quarter 2023 Financial Results & Corporate Update May 8, 2023
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 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; the expected impact of the Company’s planned acquisition of InstaDeep Ltd. and collaboration and licensing agreements with OncoC4, Inc., Duality Biologics (Suzhou) Co. Ltd and others; 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 foreign 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 6-K for the period ended March 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. This Slide Presentation Includes Forward-Looking Statements 2
COMIRNATY® ▼(the Pfizer-BioNTech COVID-19 vaccine) has been granted standard marketing authorization (MA) by the European Commission to prevent coronavirus disease 2019 (COVID-19) in the population aged 6 months and older. In people from 5 years of age and older the vaccine is administered as a 2-dose series, 3 weeks apart. Adults and adolescents from the age of 12 are given 30 micrograms per dose; children aged 5 to 11 years are given 10 micrograms per dose. There is a pediatric formulation containing 3 micrograms per dose available for infants and children 6 months to 4 years of age. In this age group, COMIRNATY can be given as primary vaccination consisting of three doses (of 3 micrograms each); the first two doses are given 3 weeks apart, followed by a third dose given at least 8 weeks after the second dose. In addition, the MA has been expanded to include a booster dose (third dose) of 30 micrograms at least 3 months after the second dose in individuals 12 years of age and older. A booster dose of COMIRNATY 10 micrograms may be given to children from 5 to 11 years of age at least 6 months after the primary vaccination course. A third primary course dose may be administered at least 28 days after the second dose to people aged 5 years and older with a severely weakened immune system. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has completed its rigorous evaluation of COMIRNATY, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available. COMIRNATY® ▼(the Pfizer-BioNTech COVID-19 vaccine), Bivalent: COMIRNATY Original/Omicron BA.1, COMIRNATY Original/Omicron BA.4-5 In addition, COMIRNATY has also been granted standard MA for two Omicron subvariant adapted vaccines: COMIRNATY Original/Omicron BA.1, which contains mRNA encoding for the spike protein of the wild-type and of the Omicron BA.1 subvariant of SARS-CoV-2; and COMIRNATY Original/Omicron BA.4-5, which contains mRNA encoding for the spike protein of the wild-type and of the Omicron BA.4/BA.5 subvariant of SARS-CoV-2. COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 (30 micrograms per dose) may be administered as a booster in people aged 12 years and older who have received at least a primary vaccination course against COVID-19. A booster dose of COMIRNATY Original/Omicron BA.4-5 (10 micrograms per dose) may be given to people aged from 5 years to 11 years after primary vaccination or a booster dose with a COVID-19 vaccine. There should be an interval of at least 3 months between administration of COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 and the last prior dose of a COVID-19 vaccine. IMPORTANT SAFETY INFORMATION: • Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. • There is an increased, but very rare risk (<1/10,000 cases) of myocarditis and pericarditis following vaccination with COMIRNATY. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. From post-marketing experience very rare adverse reactions of myocarditis and pericarditis, Rarecases of acute peripheral facial paralysis; uncommon incidence of insomnia, hyperhidrosis and night sweats, dizziness common incidence of vomiting, very common diarrhoea and unknown incidence (wcan not be estimated from available data) anaphylaxis, of paraesthesia, hypoaesthesia and erythema multiforme, extensive swelling of vaccinated limb, facial swelling (in vaccine recipients with a history of injection of dermatological fillers) and heavy menstrual bleeding(most case appeared to be non-serious and temporary in nature) have been identified after post-marketing experience.Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e. g. dizziness, palpitations, increases in heart rate, alterations in blood pressure,paresthesia, hypoesthesia and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting. • Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. • As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals. • The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COMIRNATY, COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 may be lower in immunosuppressed individuals. • As with any vaccine, vaccination with COMIRNATY, COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of the vaccine. • Adverse reactions observed during clinical studies and identified after post authorization experience are listed below according to the following frequency categories: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), • Very common side effects: injection site pain, injection site swelling, , headache, muscle pain, chills, joint pain, diarrhea, fever, chills, fatigue • Common side effects: injection site redness, nausea, vomiting • Uncommon side effects: enlarged lymph nodes (more frequently observed after the booster dose), feeling unwell, arm pain, insomnia, dizziness, injection site itching, allergic reactions such as rash,itching, urticaria or angioedema, feeling weak or lack of energy/sleepy, decreased appetite, excessive sweating, night sweats • Rare side effects: temporary one-sided facial drooping • Very rare side effects: inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis), which can result in breathlessness, palpitations or chest pain. • Not known indicence (cannot be estimated from the available data): anaphylaxis, extensive swelling of vaccinated limbs; facial swelling, pins and needles/tingling, reduced sense of touch or sensation, a skin reaction that causes red spots or patches on the skin, heavy menstrual bleeding • A large amount of observational data from pregnant women vaccinated with the initially approved COMIRNATY vaccine during the second and third trimester have not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. COMIRNATY can be used during pregnancy. No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of breast-feeding woman to the initially approved COMIRNATY vaccine is negligible. Observational data from women who were breast- feeding after vaccination have not shown a risk for adverse effects in breast-fed newborns/infants. COMIRNATY can be used during breast-feeding. • No data are available yet regarding the use of COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 during pregnancy. Since differences between products are confined to the spike protein sequence, and there are no clinically meaningful differences in reactogenicity between those COMIRNATY variant adapted vaccines that have been clinically evaluated, COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 can be used during pregnancy. • No data are available yet regarding the use of COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 during breast-feeding. Observational data from women who were breast-feeding after vaccination with the initially approved COMIRNATY vaccine have not shown a risk for adverse effects in breast-fed newborns/infants. COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 can be used during breast-feeding • Interactions with other medicinal products or concomitant administration of COMIRNATY, COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 with other vaccines has not been studied. • Animal studies with COMIRNATY Original do not indicate direct or indirect harmful effects with respect to reproductive toxicity. • In an analysis of Study 3 (Phase 2/3), 1,776 infants (1,178 Comirnaty 3 mcg and 598 placebo) were 6 to 23 months of age. The most frequent adverse reactions in infants 6 to 23 months of age that received any primary course dose included irritability (> 60%), drowsiness (> 40%), decreased appetite (> 30%), tenderness at the injection site (> 20%), injection site redness and fever (> 10%). • The most frequent adverse reactions in children 2 to 4 years of age that received any primary course dose included pain at injection site and fatigue (> 40%), injection site redness and fever (> 10%). • The overall safety profile of Comirnaty in participants 5 to 11 years of age was similar to that seen in participants 16 years of age and older. The most frequent adverse reactions in children 5 to 11 years of age that received 2 doses were injection site pain (> 80%), fatigue (> 50%), headache (> 30%), injection site redness and swelling (≥ 20%), myalgia, chills, and diarrhoea (> 10%). • The overall safety profile for the booster dose was similar to that seen after the primary course. The most frequent adverse reactions in children 5 to 11 years of age were injection site pain (> 70%), fatigue (> 40%), headache (> 30%), myalgia, chills, injection site redness and swelling (> 10%) • The overall safety profile of Comirnaty in adolescents 12 to 15 years of age was similar to that seen in participants 16 years of age and older. The most frequent adverse reactions in adolescents 12 to 15 years of age that received 2 doses were injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%) • The most frequent adverse reactions in participants 16 years of age and older that received 2 doses were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia (> 40%), chills (> 30%), arthralgia (> 20%), pyrexia and injection site swelling (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age. • The safety of a COMIRNATY Original/Omicron BA.1 booster dose in individuals from 18 to ≤ 55 years of age is extrapolated from safety data from a subset of 315 adults 18 to ≤ 55 years of age who received a booster (fourth dose) of Omicron BA.1 30 µg (monovalent) after completing 3 doses of COMIRNATY. The most frequent adverse reactions in these participants 18 to ≤ 55 years of age were injection site pain (> 70%), fatigue (> 60%), headache (> 40%), myalgia (> 30%), chills (> 30%) and arthralgia (> 20%). • In a subset from Study 4 ( Phase 3) , 305 adults > 55 years of age who had completed 3 doses of COMIRNATY, received a booster of COMIRNATY Original/Omicron BA.1 after receiving Dose 3. The overall safety profile for the COMIRNATY Original/Omicron BA.1 booster (fourth dose) was similar to that seen after the COMIRNATY booster (third dose). The most frequent adverse reactions in participants greater than 55 years of age were injection site pain (> 50%), fatigue (> 40%), headache (> 30%), myalgia (> 20%), chills and arthralgia (> 10%). No new adverse reactions were identified for COMIRNATY Original/Omicron BA.1. • The safety of a booster dose of COMIRNATY Original/Omicron BA.4-5 is inferred from safety data for a booster dose of COMIRNATY Original/Omicron BA.1 in individuals 18 years of age and older, as well as for a booster dose of COMIRNATY Original in individuals 5 years of age and older. • The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials. As with any vaccine, vaccination with Comirnaty Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 may not protect all vaccine recipients • For complete information on the safety of COMIRNATY, COMIRNATY Original/Omicron BA.1 and COMIRNATY Original/Omicron BA.4-5, always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website. The black equilateral triangle ▼ denotes that additional monitoring is required to capture any adverse reactions. This will allow quick identification of new safety information. Individuals can help by reporting any side effects they may get. Side effects can be reported to EudraVigilance or directly to BioNTech using email medinfo@biontech.de, telephone +49 6131 9084 0, or via the website www.biontech.de 3 Safety Information
AUTHORIZED USE IN THE U.S. COMIRNATY® (COVID-19 Vaccine, mRNA) • COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. It is also authorized as a third primary series dose to individuals 12 years of age and older who have certain kinds of immunocompromise • The COVID-19 vaccine is FDA authorized under Emergency Use Authorization (EUA) for use in individuals 6 months and older to provide: • the first 2 doses of the 3-dose primary series for children 6 months through 4 years of age. • a 2-dose primary series to individuals 5 years through 11 years of age • a third primary series dose to individuals 5 years and older with certain kinds of immunocompromise Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) • Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA-authorized under Emergency Use Authorization (EUA) to prevent COVID-19 as: • the third dose of the 3-dose primary series following 2 doses of the monovalent* Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age; or • a single booster dose in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with 3 doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine; or • a single booster dose at least 2 months after completion of either primary vaccination with any authorized or approved COVID-19 vaccine or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine in individuals 5 years of age and older. EMERGENCY USE AUTHORIZATION Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. IMPORTANT SAFETY INFORMATION Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), COMIRNATY® (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine • Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. • Warnings: • Management of Acute Allergic Reactions: Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. • Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinicalconsiderations/managing-anaphylaxis.html) • Myocarditis and Pericarditis: Postmarketing safety data with Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent are relevant because these vaccines are manufactured using the same process. • Postmarketing data with authorized or approved Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following receipt of the second primary series dose or first booster dose, with most booster doses likely administered at least 5 months after completing primary vaccination. For the Pfizer-BioNTech COVID-19 Vaccine, the observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html). • Syncope • Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting. • Altered Immunocompetence • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. • Limitation of Effectiveness • Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent may not protect all vaccine recipients. • Adverse reactions reported with the vaccine include: • Adverse Reactions in Clinical Trials • Adverse reactions following administration of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, injection site swelling, fever, injection site redness, lymphadenopathy, nausea, malaise, pain in extremity, rash, decreased appetite, vomiting, diarrhea (see Full EUA Prescribing Information). • Adverse Reactions Identified in Post Authorization Experience • Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in extremity (arm), syncope, and dizziness have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. • Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. • Additional adverse reactions, some of which may be serious, may become apparent with post-authorization use of the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. • Use with Other Vaccines • There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, with other vaccines. 4 Safety Information
Financial Results Jens Holstein, Chief Financial Officer3 Strategic Outlook Ryan Richardson, Chief Strategy Officer4 Pipeline Update Özlem Türeci, Chief Medical Officer2 1st Quarter 2023 Highlights Ugur Sahin, Chief Executive Officer1
1st Quarter 2023 Highlights Ugur Sahin, Chief Executive Officer
2023 Strategic Priorities and Achievements in Q1 2023 7 COVID-19 franchise1 Infectious diseasesImmuno-oncology 1. Partnered with Pfizer; 2. Collaboration with Bill & Melinda Gates Foundation; 3. Partnered with Pfizer. ADC = Antibody-drug conjugate; CTLA-4 = Cytotoxic T-Lymphocyte-Associated Protein 4. Sustain leadership in COVID-19 vaccines Advance next-gen vaccines Advance platforms for solid tumors Initiate multiple potentially registrational trials Initiate and accelerate clinical programs for high need indications Label Expansion: BA.4-5 in young children Next-generation vaccine candidate programs New manuscript in Cell Preclinical data on T cell string (BNT162b4) 2 new clinical programs Tuberculosis2 BNT164 Shingles3 BNT167 Significantly expanded technology platform portfolio 2 new collaborations DualityBio: ADCs – A promising combination backbone to our pipeline OncoC4: A differentiated anti- CTLA-4 antibody program 2023 Strategic Priorities Q1 Achievements
Long-Term Strategy: Expand Treatment Options for Solid Tumor Patients 8 1. Partnered with Genentech, member of Roche Group; 2. Partnered with Genmab; 3. Partnered with DualityBio; 4. Partnered with OncoC4. ADC = antibody-drug conjugate. mRNA cancer vaccines Cell therapies ADCs Solid tumor growth segments Open up novel options to combine platforms and therapies Address the full continuum of cancer treatment Bring novel therapies to cancer patients and establish new treatment paradigms Next-generation checkpoint immunomodulators In unique combinations Programs with first-in-class and / or best-in-class potential Programs across a wide range of solid tumors and stages of treatment Focus programs: aPD1-R/R melanoma, + PembroINDIVIDUALIZED mRNA CANCER VACCINES Autogene cevumeran BNT1221 mRNA VACCINE BOOSTED CAR-T-CELLS BNT211 NEXT GEN IMMUNO- MODULATORS BNT312 (GEN1042) 2 ANTIBODY DRUG CONJUGATES BNT323 (DB-1303)3 NEXT GEN IMMUNO- MODULATORS BNT316 (ONC-392)4 Strategy:Vision:
A New Drug Class – ADCs: Now Part of our Disruptive Technology Toolkit to Fight Human Diseases 9 1 mRNA encoded cancer-targeting antibodies and cytokines. AI = Artificial intelligence; ML = Machine learning; CAR = chimeric antigen receptor; TLR = Toll-like receptor; STING = stimulator of interferon genes. Core principles of our technology strategy Technology agnostic approach rooted in deep fundamental understanding of biology Build novel platforms with the ability to produce multiple product candidates Open up new combination opportunities which leverage synergistic modes of action Enable individualization of treatment Individualized therapiesEnabling technology ANTIBODY- DRUG CONJUGATES Duality collaboration * SELECTIVE TLR-7 AGONISM TARGETED CANCER THERAPIES RIBOLYSIN Precision antibacterials Phagomed acquisition OFF-THE- SHELF mRNA CANCER VACCINES FixVac INFECTIOUS DISEASES VACCINES Prophylactic and therapeutic vaccines INDIVIDUA- LIZED mRNA CANCER VACCINES INDIVIDUALIZED TCR-THERAPY INDIVIDUALIZED EX VIVO T-CELL THERAPY SOLID TUMOR CAR-T Ideal CAR-T- cell targets MULTI- TARGET TCR Internal capabilities & Medigene collaborationCARVac mRNA vaccine boosted CAR-T-cells STING AGONISTS Ryvu collaboration LIPID- FORMULATIONS Internal capabilities & Matinas collaboration IMMUNO- THERAPY TARGET DISCOVERY mRNA TECHNOLOGY CELL & GENE THERAPIES ANTIBODIES SMALL MOLECULES NEXT GEN IMMUNO- MODULATORS Mono and Bispecific Abs Newly added platform AI & ML Internal capabilities & InstaDeep RIBO- LOGICALS1 RiboCytokines RiboMabs I I t l iliti i ll ti mRNA ENCODED HUMABODIES Crescendo collaboration
Antibody-Drug Conjugates: A Proven Technology with Untapped Potential 10 1. Jabbour E. et al. Nat Rev Clin Oncol. 2021. 2. Coleman N.et al. npj Precis. Onc. 2023. ADC = Antibody-drug conjugate; Ig = Immunoglobuline; MoA = Mode of action. Each of these three components can vary between different ADCs, which may lead to contrasting pharmacological and clinical properties. Linker Conjugates the payload to the antibody Should remain stable in the circulation while allowing selective intracellular and extracellular release Two main types: 1. Cleavable 2. Non-cleavable Antibody High specificity minimizes the risk of off-target effects Formation of antibody-antigen complexes leads to internalization Payload Highly potent cytotoxic compounds typically derived from natural sources Main types: 1. DNA crosslinker 2. Microtubule inhibitor 3. DNA alkylator 4. Topoisomerase inhibitor Mode of Action2ADCs are composed of three key components1 1. ADC binds to antigen 2. Internalization of the ADC complex by endocytosis 3. Payload released after linker cleavage Target antigen ADC A promising combination backbone to our pipeline 4. Cytotoxic effect by payload in the nucleus Bystander cell Classical ADC MoA Bystander killing effect A. Release of drug payload after antigen binding before internalization B. Release of drug payload into the intercellular space due to a high drug membrane permeability ADC
11 3rd generation ADCs with pharmacokinetic properties that may contribute to an increased therapeutic window:5 • superior systemic stability • rapid systemic clearance of released payload • efficient bystander killing • sustained tumor-selective drug release • well-tolerated in animal models at repeated dosing up to 80 mg/kg • Broad combination potential with other BioNTech programs • Could replace chemotherapy and complement IO combinations • Potential to unlock larger patient population Phase 1/2 in HER2+ solid tumors ongoing, expansion cohorts in progress:3,4 • Breast cancer • Endometrial cancer • Gastrointestinal cancer • HER2-mutated non-small cell lung cancer Our 3rd Generation ADCs May Overcome Hurdles of Currently Approved ADCs • A proven technology with first FDA approval in 20001 • Today 14 different ADCs approved in various cancer indications from late line to 1L metastatic settings1 • ADCs precisely deliver cytotoxic payloads to tumors, potentially replacing traditional highly toxic chemotherapy regimens2 • One of the fastest growing drug classes of oncology drugs in development2 DB-1303*ADC drug class Combination potential Clinical development strategy* 1. Fu Z et al. Sig Transduct Target Ther. 2022. 2. Coleman N. et al. npj Precis. Onc. 2023. 3. NCT05150691. 4. Hamilton E. et al. #9504. Presented at AACR 2023. 5. Lin S. et al. Abstract #252. Presented at EORTC-NCI-AACR in 2022. * Partnered with DualityBio. ADC = Antibody-drug conjugate; FDA = Food and Drug Administration; IO = Immuno-oncology; HER2 = human epidermal growth factor 2; 1L = first line.
12 ID = Infectious disease; IND = Investigational new drug. Advancing Toward Our Vision Infectious diseases 6 Phase 2 trials Globally successful marketed COVID-19 vaccine with first-to-market BA.4-5-adapted booster 7 programs in 8 clinical trials 20 programs in 24 clinical trials Maintain and deepen COVID-19 vaccine leadership Multiple oncology and infectious disease product launches in next 3-5 years Mid-term goalsDriving transformation today Long-term vision 5-10 IND submissions per year Next-generation and combination COVID-19 vaccines Approved products across various disease areas Cardiovascular diseases Neurodegenerative diseases Autoimmune diseases Oncology By 2030, 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 1 Phase 2 trial 1 Phase 3 trial
Pipeline & COVID-19 Vaccines Update Özlem Türeci, Chief Medical Officer
Well-Positioned with our Cancer Vaccine Portfolio Across Multiple Solid Tumors 14 1 Partnered with Genentech, member of Roche Group. iNeST = individualized NeoAntigen Specific Immunotherapy; ADT = androgen deprivation therapy; 1L = First line; R/R = relapsed/refractory; NSCLC = Non-small cell lung cancer; HPV = Human papillomavirus; CRC = Colorectal cancer; HNSCC = head and neck squamous carcinoma; PDAC = pancreatic ductal adenocarcinoma; PFS = Progression-free survival; Pembro = Pembrolizumab; mFOLFIRINOX = modified FOLFIRINOX. iNeST1 FixVac Multiple SolidTumorsCRC Adjuvant PDAC Prostate Cancer MelanomaHPV16+ HNSCC NSCLC Multiple trials ongoing (4 Phase 2) with cancer vaccine candidates in multiple disease settings Melanoma 1L R/R Autogene cevumeran (BNT122) + Atezolizumab Autogene cevumeran (BNT122) Monotherapy Autogene cevumeran (BNT122) + 1x Atezolizumab BNT112 Monotherapy & + Cemiplimab + ADT BNT111 +/- Cemiplimab Pembrolizumab +/- BNT113 BNT116 Monotherapy & Cemiplimab or CTx Autogene cevumeran (BNT122) + Pembrolizumab • Ph 2 study is ongoing • Data presented from investigator-initiated Ph 1 study at ASCO 2022 • Ph 2 study planned to start in 2023 • Ph 1 data presented • Publication in preparation • Ph 1/2 is ongoing • Ph 2 study is ongoing • Ph 2 study is ongoing • Ph 1 basket study is ongoing • Ph 2 in 1L NSCLC planned to start in 2023 • Ph 2 enrollment completed • Analysis of PFS as primary endpoint will be triggered event-based and defines when we will report results 1LMultiple settings R/R Multiple settings
Oncology Pipeline: Achievements in Q1 2023 15 1. Investigator-initiated / Investigator-initiated and sponsored trial; 2. Partnered with Genentech, member of Roche Group; 3. Partnered with Sanofi; 4. Partnered with Genmab; 5. Partnered with OncoC4; 6. Partnered with DualityBio. NSCLC = Non-small cell lung cancer; HPV = Human papillomavirus; CLDN = Claudin; IL = Interleukin;1L = first line; TLR = Toll-like receptor; R/R = Relapsed/Refractory; Plat.-R. = Platinum-resistant; ADC = Antibody-drug conjugate; SMIM = small molecule immunomodulator. Phase 1 (5 First-in-Human) BNT112 Prostate cancer BNT116 2L NSCLC BNT111 aPD1-R/R melanoma, + Pembrolizumab BNT113 1L rec./met. HPV16+ PDL1+ head and neck cancer, + Pembrolizumab Autogene cevumeran (BNT122)2 1L Adv. melanoma, + Pembrolizumab BNT131 (SAR441000)3 Solid tumors (IL-12sc, IL15-sushi, GM-CSF, IFNα) BNT141 (CLDN18.2) Multiple solid tumors BNT151 (IL-2 variant) Multiple solid tumors BNT152 + BNT153 Multiple solid tumors (IL-7, IL-2) BNT211 (CLDN6) Multiple solid tumors BNT221 Refractory metastatic melanoma BNT311 (GEN1046)4 (PD-L1x4-1BB) Multiple solid tumors BNT321 Pancreatic cancer (sLea) BNT411 (TLR7) Multiple solid tumors BNT311 (GEN1046)4 (PD-L1x4-1BB) aPD1-R/R NSCLC, + Pembrolizumab BNT312 (GEN1042)4 (CD40x4-1BB) Multiple solid tumors BNT313 (GEN1053)4 (CD27) Multiple solid tumors BNT322 (GEN1056)4 Multiple solid tumors (undisclosed) BNT316 (ONC-392)5 (CTLA-4) Multiple solid tumors Autogene cevumeran (BNT122)2 Adjuvant colorectal cancer BNT142 (CLDN6) Multiple solid tumors Phase 1/2 BNT316 (ONC-392)5 (CTLA-4) Plat.-R ovarian cancer, + Pembrolizumab BNT1131 HPV16+ head and neck cancer BNT111 Advanced melanoma Drug Class mRNA Cell therapy Protein-based Therapeutics Autogene cevumeran (BNT122)2 Multiple solid tumors SMIM Phase 2 BNT323 (DB-1303)6 (HER2) Multiple solid tumors
MoA Designed to Allow Higher Dosing & Longer Duration of BNT316 (ONC-392) Treatment1 16 1. Partnered with OncoC4. MTD = Maximum tolerated dose; RP2D = Recommended phase 2 dose; DLT = Dose-limiting toxicity; TRAE = Treatment related adverse event; NSCLC = Non-small cell lung cancer; irAE = immune-related adverse event; IO = immuno-oncologic. • BNT316 (ONC-392) dosed as monotherapy and in combination with pembrolizumab were well tolerated • TRAE were manageable, no DLTs, MTD not reached • Monotherapy RP2D: 10 mg/kg, Combination RP2D: 6 mg/kg • Preliminary data demonstrated lower irAE rate than observed for comparable IO or IO-IO combinations • Safety profile of BNT316 (ONC-392) allows for higher dosing and longer duration of treatment in monotherapy and in combination with pembrolizumab Safety data and study conclusions BNT316 (ONC-392) (3 or 6 mg/kg) in combination with pembrolizumab Hu-Lieskovan et al. Poster #594. Presented at SITC 2022 Monotherapy (10 mg/kg) in platinum- resistant ovarian cancer patients Hays J et al. Poster #564. Presented at SITC 2022 % C h a n g e f ro m B a se lin e in T a rg e t L e si o n s 30% 20% 10% 0% -10% -20% -30% -40% -50% -60% -70% * SDSD SDSDSDPD PD PD PDPDSDSDSDPD PD PD PD PD PD PD PD PD PR CRPRPRPRPR 60% 50% 40% -80% 138% Best Overall Response 30% 20% 10% 0% -10% -20% -30% -40% -50% -60% -70% -80% Best Overall Response % C h a n g e f ro m B a se lin e in T a rg e t L e si o n s PD NSCLC data update from PRESERVE-001 study Abstract # 9024; Poster #12 and Presented in Poster Discussion Session, June 4, 4:30 PM GMT NEW Data at ASCO 2023 Mode of Action Liu Y. et al. Abstract # 231, SITC 2021. Autoimmunity Endosome pH<6.0 Recycling endosome Recycling FcR ADCC/ADCP Anti-tumor immunity C T L A -4 C T L A -4 C T L A -4 C T L A -4 C T L A -4 C T L A -4 C T L A -4 C T L A -4 C T L A -4 C T L A -4
First Phase 3 Study planned: BNT316 (ONC-392) in IO R/R NSCLC1 17 1. Partnered with OncoC4.. PD-1 =Programmed cell death protein 1; IO = immuno-oncology; NSCLC = Non-small cell lung cancer; R/R = Relapsed/Refractory; Q3W = Every three weeks; OS = Overall survival; ORR = Objective response rate; PFS = Progression free survival; ECOG = Eastern Cooperative Oncology Group. PRESERVE-003 (NCT05671510) Randomized, open-label, active controlled, multi-center Phase 3 trial Inclusion criteria • ≥ 18 years stage IV, metastatic NSCLC • Prior PD-(L)1 +/- platinum-based chemotherapy • Prior IO-IO allowed • ECOG Performance Status: 0 or 1 • Have RECIST 1.1 measurable lesions Stage I (dose-confirmation stage): Assess efficacy and safety of two BNT316 (ONC-392) dosing regimens in comparison to docetaxel BNT316 (ONC-392) 6mg/kg with 2 loading doses of 10mg/kg, Q3W (N=40) R 1:1:1 N=120 Stage II: Assess safety and efficacy of BNT316 (ONC-392) at the selected dosing regimen versus docetaxel Docetaxel 75 mg/kg, Q3W (N=240) BNT316 (ONC-392) BNT316 (ONC-392) 3mg/kg, Q3W (N=40) Docetaxel 75 mg/kg, Q3W (N=40) Historic efficacy of docetaxel monotherapy (Garon et al. Lancet. 2014): ORR ~10%; mPFS = 3 months; mOS = 9 months R 1:1 N=480 Key endpoints Primary: OS Secondary: ORR, PFS, Safety Trial in Progress PRESERVE-003 study, Abstract # TPS9146, Poster Time: June 4, 8:00 AM-11:00 AM GMT, Poster #130b 130b, TBD: mg/kg, Q3W (N=240)
18 Lin S. et al. Abstract #252. Presented at EORTC-NCI-AACR in 2022. 1. Partnered with DualityBio. ADC = Antibody-drug conjugate; HER = human epidermal growth factor receptor; cmax = maximum concentration; DAR = Drug antibody ratio. Superior in vitro plasma stability in human plasma Sustained tumor-selective drug release in tumor-bearing mice Efficient bystander killing in tumor cell lines Rapid systemic clearance in monkeys DB-1303 DS-8201* C h an ge o f D A R f ro m b as el in e 120 100 80 60 40 20 0 48 96 144 192 240 288 336 384 Incubation time (hr) C el l n um be r 1x106 8x105 6x105 4x105 2x105 0 V eh ic le D B -1 30 3 0. 3µ g/ m l T -D M 1* * 0. 3µ g/ m l T -D M 1* * 0. 1µ g/ m l D B -1 30 3 0. 1µ g/ m l HER2 - HER2 + P ay lo ad ( ng /m l) 0 7 14 21 14 28 42352170 Free payload of DS-8201* Free payload of DB-1303 C o nc en tr at io n (n g/ m l) 0 150100 Time (hr) 50 DB-1303 released payload in serum and tumor Payload Cmax in tumor=22.3 ng/ml Payload Cmax in serum=0.48 ng/ml 1 BNT323 (DB-1303)1 pharmacokinetic and -dynamic properties may contribute to an increased therapeutic window *DS-8201 is an in-house produced analog of DS-8201, Trastuzumab deruxtecan. **Trastuzumab-Emtansin. Payload-Serum Payload-Tumor 3rd-generation ADCs with improved safety and efficacy may bring added survival benefit to cancer patients
BNT323 (DB-1303): Preclinical Data Show Anti-Tumor Effect and Favorable Safety Profile in HER2 Positive & HER2 Low Tumor Models and Toxicity Studies1 19 Lin S. et al. Abstract #252. Presented at EORTC-NCI-AACR in 2022. 1. Partnered with DualityBio. HER = human epidermal growth factor receptor; ILD = interstitial lung disease; PDX = patient-derived xenograft. Safety dataEfficacy data • BNT323 (DB-1303) induced dose-dependent tumor growth inhibition and tumor regression • Potent anti-tumor effect in both, HER2 positive and HER2 low tumor models with a wide therapeutic window Vehicle T-DM1, 7mg/kg, single dose DB-1303, 2mg/kg, single dose DB-1303, 7mg/kg, single dose DB-8201*, 2mg/kg, single dose DB-8201*, 7mg/kg, single dose T um o r vo lu m e (m m 3 ) HER2 positive (HER2 2+) PDX tumor model 1000 800 600 400 200 0 7 14 21 28 Days post dosing T um o r vo lu m e (m m 3 ) HER2 low (HER2 1+) PDX tumor model 800 600 400 200 0 7 14 21 28 Days post dosing • Toxicity studies in cynomolgus monkey showed improved safety profile compared to published profile of DS- 8201 • Highest non-severely toxic dose 80mg/kg • DB-1303 showed lowered risk of causing lung inflammation compared to published profile of DS-8201 • No ILD-like lung toxicity • Stable linker and fast clearance may contribute to the superior safety profile of DB-1303 *DS-8201 is a in-house produced analog of DS-8201, Trastuzumab deruxtecan
FIH Phase 1/2 to Evaluate Safety and Tolerability of BNT323 (DB-1303) in Patients with Advanced HER2+ Solid Tumors1 1. Partnered with DualityBio. IHC = immunohistochemistry; FIH = First in human; Q3W = every three weeks; DLT = dose limiting toxicity; HER2 = human epidermal growth factor 2; HR = hormone receptor; CRC = colorectal cancer; NSCLC = non-small cell lung cancer; MTD = maximum tolerated dose; RP2D = recommended phase 2 dose; ECOG = Eastern Cooperative Oncology Group; FPI = First patient in; LPO = Last patient out; ISH = in-situ hybridization; NGS = next-generation sequencing. FPI: Jan 2022 Objective: To assess safety, tolerability, pharmacokinetic, preliminary anti-tumor activity at the selected MTD/RP2D DB-1303 6 mg/kg Q3W DB-1303 7 mg/kg Q3W DB-1303 8 mg/kg Q3W DB-1303 10 mg/kg Q3W DB-1303 12 mg/kg Q3W DB-1303 4.4 mg/kg Q3W DB-1303 2.2 mg/kg Q3W Part 1: Dose Escalation (n=88 patients) Part 2a: Dose expansion (n=165 patients) Phase 1/2a study design (NCT05150691), multicenter, non-randomized, open-label, multiple-dose, FIH study Hamilton E. et al. TiP #9504. Presented at AACR 2023 Indications • HER2+ gastric, esophageal or gastroesophageal junction adenocarcinoma, CRC • HR+/HER2-low breast cancer • HER2+ breast cancer • HER2 overexpression and HER2-low endometrial cancer • HER2-mutated NSCLC 3 weeks DLT window Disease progression, withdrawal of consent, unacceptable toxicity Inclusion criteria • Pretreated advanced or metastatic solid tumors • Histologically confirmed HER2-positive or HER2- expressing cancers • Previous systemic therapies • ECOG 0-1 • Adequate organ function 20 (HER2 IHC 3+, IHC 2+, IHC 1+ or ISH +, or HER2 amplification by NGS, or HER2 mutation by NGS)
Phase 1 BNT162b2 (Original/Omicron BA.4-5-adapted bivalent)1 COVID-19 Pfizer Partnered Programs COMIRNATY1 COVID-19 BNT162b2 (Original/Omicron BA.1-adapted bivalent)1 COVID-19 BNT162b51 (Enhanced spike antigen) COVID-19 BNT162b4 + BNT162b21 (T-cell enhancing) COVID-19 BNT1633 HSV-2 Infectious Disease Pipeline: Achievements in Q1 2023 21 1. Partnered with Pfizer; 2. Collaboration with PFE and subject to reaching agreement with our partners; 3. Collaboration with University of Pennsylvania; 4. In collaboration with Bill & Melinda Gates Foundation; 5. Exclusive license to Pfizer. HSV = Herpes simplex virus. BNT162b2+BNT1612 (qFlu + BA.4-5-adapted bivalent) COVID-19/Influenza combination BNT1615 Influenza BNT1671 Shingles Phase 2 CommercialPhase 3 BNT165 Malaria Proprietary Vaccines BNT1644 Tuberculosis Global Health Programs
Initiated Phase 1/2 Trial of Tuberculosis mRNA-LNP Vaccine Candidates1 22 1. Collaboration with BMGF; 2. WHO, Tuberculosis Report 2021. 3. NCT05537038. Unmet medical need Objective of vaccine development Target population & trial design3 Tuberculosis is the second leading infectious killer worldwide after COVID-19 (above HIV/AIDS)2 Current prophylaxis treatment has seen limited uptake due to variable efficacy and pathogen drug-resistance Ending tuberculosis epidemic by 2030 still one of the health targets of the United Nations Sustainable Development Goals2 Development of mRNA vaccine candidates, encoding bacterial antigens for active immunization against tuberculosis Development of a prophylactic vaccine against tuberculosis Elimination of tuberculosis through effective immunization Target population: IGRA-negative and positive, BCG naïve and vaccinated healthy adults. Clinical trials in Germany (non-endemic) and South Africa (endemic) Trial design: Three-dose schedule (0 / ~8 W / ~16 W), 2 candidates, 6 dose levels Primary endpoints: Safety Exploratory endpoints: Immune response
COVID-19 Franchise: Being Actionable in the Face of a Dynamic Virus Evolution and Building for Continued Success 23 HLA = Human Leukocyte Antigen; ORF = open reading frame T cell immune response may continue to contribute to prevention or limitation of severe disease Muik A. et al. bioRxiv pre-print. 2022 Induction of T cell responses to non-spike SARS-CoV-2 antigens to broaden the immune response and address immune evasion of new variants of concern Arieta C. et al. Cell.2023. DOI: 10.1016/j.cell.2023.04.007 • Progressive loss of conserved B cell epitopes for spike protein neutralizing antibody sites in Omicron sublineages • Preservation of HLA class I and class II presented T-cell epitopes across the evolution of SARS-CoV-2 spike protein • T-cell recognition of newly occurring variants of concern may be largely intact % unaltered HLA class I T-cell epitopes % unaltered HLA class II T-cell epitopes % unaltered neutralizing B -cell epitopes The cell string (BNT162b4) encodes variant-conserved, immunogenic segments of the SARS-CoV-2 nucleocapsid, membrane, and ORF1ab proteins, targeting diverse HLA alleles • mRNA vaccine component designed to enhance T cell immunity • variant-conserved, immunogenic segments of SARS-CoV-2 proteins • Intended to be combined with the variant-adapted spike protein vaccine component (BNT162b2)
Next-Generation COVID-19 Vaccine Component Candidate BNT162b4 Encoding Conserved Non-Spike Antigens Protects Animals from Severe COVID-191 24 Arieta C. et al. Cell.2023. DOI: 10.1016/j.cell.2023.04.007 1. Partnered with Pfizer. In animal models Elicits polyfunctional CD4+ and CD8+ T cell responses Non-spike specific T cells increased by both BNT162b4 monovalent vaccination and in combination with spike protein component BNT162b2 Protects hamsters from severe disease, reduces viral titers with viral variants Effective alone or when co-administered with BNT162b2 BNT162b4 is currently being evaluated in a clinical trial with BA.4-5 Omicron-updated bivalent BNT162b2 (NCT05541861)1 Membrane T cells Nucleocapsid T cells ORF1ab T cells Challenge strain: Sars-Cov-2 US-WA 1/2020 NR-52281 Challenge strain: Sars-Cov-2 Delta VARIANT NR-56116
Financial Results Jens Holstein, Chief Financial Officer
Q1 2023 Key Highlights1 26 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 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, 2022 as well as the Quarterly Report as of and for the three months ended March 31, 2023, filed as an exhibit to BioNTech’s Current Report on Form 6-K filed on May 8, 2023. 3 Consists of cash and cash equivalents of €12,143.9 million and security investments of €671.9 million, as of March 31, 2023. The payment settling our gross profit share for the fourth quarter of 2022 (as defined by the contract) in the amount of €3,961 million was received from our collaboration partner subsequent to the end of the reporting period as of April 14, 2023. M&A activities and recent collaboration and license agreements announced in the first quarter did not lead to cash outflows until March 31, 2023. Cash outflows and share considerations in connection with the planned acquisition of InstaDeep and the upfront payments of the collaboration and license agreements with OncoC4 and Duality Biologics of approximately €0.8 billion are expected (subject to change and excluding future potential earn-out and milestone payments). €12.8bn €1.3bn €0.7bn €2.05 Total revenues2 Operating result Diluted EPS Total cash plus security investments3
Q1 2023 Financial Results: Profit or Loss 27 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 unaudited interim 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, 2022, as well as the Quarterly Report as of and for the three months ended March 31, 2023, filed as an exhibit to BioNTech’s Current Report on Form 6-K filed on May 8, 2023. Any changes in the estimated share of the collaboration partner's gross profit will be recognized prospectively. Three months ended March 31,(in millions €, except per share data)1 20222023 6,362.21,276.5Commercial revenues2 12.40.5Research & development revenues 6,374.61,277.0Total revenues (1,294.1)(96.0)Cost of sales (285.8)(334.0)Research and development expenses (14.3)(12.2)Sales and marketing expenses (90.8)(119.4)General and administrative expenses 63.1(61.0)Other operating income less expenses 4,752.7654.4Operating income 265.453.3Finance income less expenses (1,319.3)(205.5)Income taxes 3,698.8502.2Profit for the period Earnings per share 15.132.07Basic profit for the period per share 14.242.05Diluted profit for the period per share
2023 Financial Year Guidance Reiterated1 28 2 Numbers include effects identified from additional collaborations or potential M&A transactions to the extent disclosed and will be updated as needed. ~ €5 bnEstimated BioNTech COVID-19 vaccine revenues COVID-19 vaccine revenues for FY 2023 €2,400 – 2,600 mR&D expenses2 Planned FY 2023 expenses and capex €650 – 750 mSG&A expenses €500 – 600 mCapital expenditure for operating activities3 ~ 27%BioNTech Group estimated annual cash effective income tax rate Estimated FY 2023 tax assumptions 3 Numbers exclude potential effects caused by or driven from collaborations or M&A transactions. 1 Numbers reflect current base case projections and are calculated based on constant currency rates.
Strategic Outlook Ryan Richardson, Chief Strategy Officer
Outlook for COVID-19 Vaccine Franchise in 2023 30 WHO = World Health Organisation; ICMRA = International Coalition of Medicines Regulatory Authorities; VRBPAC = Vaccines and Related Biological Products Advisory Committee; FDA = Food and Drug Administration; EMA = European Medicines Agency Expected WHO/ICMRA recommendation May 2023 Expected Launch & Shipment September 2023 August /September 2023 VRBPAC June 2023 Monitoring of emerging variants • Launch Comirnaty vaccine adapted to the 2023 seasonal SARS-CoV-2 variant, as recommended by regulatory authorities • Introduce single-dose ready to use vial • Advance key Comirnaty features (e.g., extension of shelf-life) • Advance next generation COVID-19 vaccines Applications to and review by regulators Vaccine Development Expected timeline for variant-adapted vaccine development: Ongoing Possible FDA and EMA approvals
2023 market dynamics & outlook Potential mid-term growth drivers COVID-19 Market Outlook 31 • Doses already shipped to >70 countries and regions • Increased deliveries in middle-income and low-income countries in Q1 2023 • Increased contribution from pediatric segment in Q1 2023 • U.S. commercial market opening expected in 2H 2023 in conjunction with launch of variant-adapted vaccine Value proposition could support increased vaccination rate in at-risk populations once global seasonal market is established Continued product innovation • Variant adapted vaccines • Next-generation vaccines • Vaccine combinations Commercial pricing
Multiple Late- and Early-Stage Pipeline Milestones Expected in 2023 32 1. Partnered with Pfizer; 2. Collaboration with Pfizer and subject to reaching agreement with our partners, 3. Partnered with University of Pennsylvania; 4. Collaboration with Bill & Melinda Gates Foundation; 5. Partnered with Genentech, a member of Roche Group; 6. Investigator-initiated trial, 7. Collaboration with Genmab, 8. Collaboration with OncoC4 FPD = First Patient Dosed, CRC = Colorectal cancer, PDAC = Pancreatic ductal adenocarcinoma, HSV = Herpes simplex virus, NSCLC = Non-small cell lung cancer, CLDN6 = Claudin 6, 1L = first line, 2L = second line Anticipated timing Select milestonesProgramIndicationModality 2H 2023Pediatric label expansionBA.4-5-adapted bivalentCOVID-191 mRNA vaccines for infectious disease 2023Phase 1 data updateBA.4-5-adapted bivalent+ BNT161 COVID-19 – influenza Combination1,2 2H 2023Phase 1 data updateBNT163Malaria 2H 2023Phase 1 data updateBNT165HSV-23 2023Phase 1 data updateBNT167Shingles1 Phase 1 FPD April 2023BNT164Tuberculosis4 2H 2023Phase 2 data updateAutogene Cevumeran (BNT122)1L melanoma5 iNeST individualized mRNA vaccines -Phase 2 data updateAutogene Cevumeran (BNT122)Adjuvant CRC5 2023Phase 2 FPDAutogene Cevumeran (BNT122)Adjuvant PDAC6 2023 Expansion cohort data update BNT311 (PD-L1x4-1BB)Multiple solid tumors7 Next-gen immune checkpoint modulators 2023 Expansion cohort data update BNT312 (CD40x4-1BB)Multiple solid tumors7 2023Phase 3 FPDBNT316 (CTLA-4)2L NSCLC8 2023Phase 1 data updateBNT211CLDN6+ solid tumors Cell therapies 2024Phase 2 FPDBNT2112L+ testicular cancer Clinical Data at ASCO BNT316 (ONC-392) Abstract #9024 Poster Presentation BNT211 Abstract #2518 Poster Presentation BNT323 (DB-1303) Abstract #3023 Poster
Annual General Meeting May 25, 2023 Innovation Series Day November 7, 2023 SAVE THE DATE
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