“2023 was another year of smart functionality for BioNTech. We have maintained our leading position in the COVID-19 vaccine market, laying the foundation to build a sustainable respiratory vaccine business. In oncology, we have strengthened our core competencies by entering into several partnerships, and we have made many clinical breakthroughs. Today, our oncology portfolio encompasses several mid- and late-stage applicants in clinical development, adding investigational ADCs, mRNA vaccines, and cutting-edge immunotherapies,” said Prof. Ugur Sahin, M. D. , CEO and co-founder of BioNTech. ” Our goal is to achieve product approval in ten oncology indications by 2030 and improve the functions of the remedy for patients around the world.
Financial Review of Fourth Quarter and Full Year 2023 Financial Results
Total reported profit of €1,479. 0 million for the 3 months ended December 31, 2023, compared to €4,278. 3 million for the comparative period of the prior year. For the year ended December 31, 2023, overall profit amounted to €3,819. 0 million, compared to €17,310. 6 million in the comparative period of the previous year. Inventory impairments acquired through Pfizer, Inc. (“Pfizer”), a partner of BioNTech, reduced BioNTech’s earnings by €291. 3 million and €906. 7 million for the third year ended December 31, 2023. respectively.
Cost of goods sold amounted to €179. 1 million for the three-month period ended December 31, 2023, compared to €183. 5 million in the same period last year. For the year ended December 31, 2023, cost of sales amounted to €599. 8 million. , compared to €2,995. 0 million in the same period last year. This update is primarily due to declining sales of COVID-19 vaccines.
Research & Expenditure (R&D)
General & Administrative (G
Income taxes were recorded for the three months ended December 31, 2023, compared to €893. 9 million in the same period last year. For the year ended December 31, 2023, income tax sources amounting to €255. 8 million were identified. compared to €3,519. 7 million identified in the corresponding era last year. The derived annual effective tax rate for the year ended December 31, 2023 was 21. 6%.
Net profit amounted to €457. 9 million for the 3 months ended December 31, 2023, to €2,278. 7 million for last year’s comparative era. For the year ended December 31, 2023, net profit amounted to €930. 3 million, to €9,434. 4. million in the corresponding era last year.
Cash and cash equivalents as security investments2 as of December 31, 2023 amounted to €17,653. 4 million, of which €11,663. 7 million were cash and cash equivalents and €5,989. 0 million were security investments.
Diluted earnings consistent with the consistent percentage were €1. 90 for the 3 months ended December 31, 2023, to diluted earnings consistent with the consistent percentage of €9. 26 for the same period consistent with last year. For the year ended December 31, 2023, diluted earnings consistent with concentage amounted to €3. 83, up to €37. 77 of diluted earnings consistent with concentrage for the corresponding prior year.
As of December 31, 2023, the number of noteworthy shares stood at 237,725,735, of which 10,826,465 treasury shares.
In March 2023, the Board of Directors and the Supervisory Board approved the 2023 percentage buyback program, under which BioNTech is legal to acquire ADSs, each representing a non-unusual percentage, valued at up to $500 million, which commenced on June 2, 2023 and ended. . September 18, 2023. In the quarter ended December 31, 2023, 114,513 ADSs were repurchased under the percentage buyback program for an average value of $112. 22 (€105. 07), for an overall service of $12. 9 million (€12. 0 million). As of December 31, 2023, a total of 4,646,965 ADSs were repurchased under the 2023 program for an average value of $107. 58 (€98. 24), for an overall care of $500 million (€456. 5 million).
“In 2023, we strengthened our monetary position while advancing our clinical immunotherapy pipeline and completing acquisitions and collaborations. Looking ahead to 2024, we will maintain a prudent capital allocation strategy as we make an investment, execute our maturation pipeline, and prepare for our first launch. “Potential oncology launches,” said Jens Holstein, BioNTech’s chief financial officer. “Our COVID-19 vaccine franchise is expected to remain a major money contributor in 2024. We believe our strong monetary position will allow us to advance our long-term strategy to expand novel treatments for cancer, infectious diseases and other serious diseases, generating added price for patients, society, investors and the company.
FY2024 Outlook
The Company’s outlook is as follows:
BioNTech expects the group’s profit for the full year 2024 to be between €2. 5 billion and €3. 1 billion. Diversity reflects safe assumptions, including, but not limited to, expectations regarding: the timing and issuance of regulatory approvals and recommendations, COVID-19 vaccine adoption and price levels, stock deterioration through BioNTech’s collaborative partner, Pfizer, which could adversely affect the company’s results. The profits, seasonal diversifications in the flow of SARS-CoV-2 and vaccination rates that are expected to lead to peaks in demand in autumn and winter in comparison to other seasons, the benefits of a pandemic preparedness contract with the German government, as well as the benefits of the service companies of the BioNTech group, namely InstaDeep, JPT Peptide Technologies GmbH and in Idar-Oberstein, BioNTech Innovative Manufacturing Services GmbH. Overall, the company remains heavily dependent on the profits generated in the territories of its collaboration partners in 2024.
Planned Expenditures and Investments for Fiscal Year 2024:
BioNTech plans to continue its investments in R&D
The complete audited consolidated monetary statements as of December 31, 2023 and for the year ended December 31, 2023 are contained in BioNTech’s Annual Report on Form 20-F for the period ended December 31, 2023, filed today with U. S. Securities and Exchange Commission (the “Annual Report”).
Endnotes
1 Calculated using the average exchange rate for the monetary year ending December 31, 2023, published through the German Central Bank (Deutsche Bundesbank). 2 The contractual agreement of the percentage of gross profit has a time lag of more than one calendar quarter. Because Pfizer’s monetary quarter for subsidiaries outside the United States differs from that of BioNTech, this creates an additional lag between the popularity of cash and receipt of payment. 3 The figures reflect existing base case projections and are calculated based on consistent exchange rates and exclude external risks. that are not yet known and/or quantified, adding, among others, the effects of ongoing and/or long-term legal litigation or similar activities. 4 The figures come with known effects of future collaborations or possible M&A transactions in to the extent they are disclosed and are subject to update due to long-term developments. 5 Anticipated expenses similar to outside legal counsel in connection with certain legal disputes are reflected not in general and administrative expenses, but in other operating expenses. Guardianship is not accompanied by, and could not be affected by, potential bills resulting from the effects of terminations or long-term legal litigation or similar activities, such as judgments or settlements.
Fourth Quarter 2023 Operational Review, Key Post-Period Occasions, and 2024 Outlook
Monovalent COVID-19 vaccine adapted to Omicron XBB. 1. 5 (COMIRNATY) ®
COVID-19 – Combined Flu Vaccine Program
BNT162b2 BNT161 is an mRNA-based vaccine program for COVID-19 and influenza developed in collaboration with Pfizer.
Select Oncology Portfolio Highlights
BioNTech’s vision for oncology is to bring new treatments to patients and address the continuum of cancer treatment, from early to late. Addressing the root causes of cancer treatment failure, such as cancer heterogeneity and inter-individual variability, is critical. of your strategy. To develop anti-tumor activity and counteract resistance mechanisms, BioNTech seeks to blend compounds with synergistic and non-overlapping mechanisms of action.
In 2023, the company’s product portfolio continued to mature as the system complex progresses to additional stages of expansion. BioNTech’s oncology portfolio currently comprises 10 ongoing Phase 2 and 3 trials. In 2024, the company plans to continue expanding its portfolio in preparation for its first planned oncology. BioNTech aims to achieve ten indication approvals by 2030.
Antibody-Drug Conjugate (ADC) Programs
BNT323/DB-1303 is an ADC candidate human epidermal expansion (HER2) element 2 that is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“Bio Duality”).
BNT325/DB-1305 is an ADC candidate trophoblastic mobile surface antigen 2 (“TROP2”) that is being developed in collaboration with DualityBio.
Next-Generation Immune Checkpoint Immunomodulatory Programs
BNT316/ONC-392 (gotistobart) is an anti-CTLA-4 monoclonal antibody candidate being developed in collaboration with OncoC4, Inc. (“OncoC4”).
BNT311/GEN1046 (acasunlimab) is a first-in-class bispecific antibody candidate that combines PD-L1 checkpoint inhibition with 4-1BB costimulatory activation that is being developed in collaboration with Genmab S/A (“Genmab”).
BNT312/GEN1042 is a potential first-of-its-kind, bispecific antibody candidate designed to induce conditional immune activation by cross-linking CD40 and 4-1BB cells, developed in collaboration with Genmab.
BNT327/PM8002 is an anti-VEGF-A anti-VEGF-A anti-PD-L1 humanized HHV antibody candidate being developed in collaboration with Biotheus Inc. (“Biotheus”). BNT327/PM8002 is being compared lately in Phase 1 and Phase 2/3 clinical trials in China to compare the efficacy and protection of the candidate as monotherapy or in combination with chemotherapy in indications, adding first-line mobile lung cancer (“SCLC”). ) and second-line epidermal expansion receptor (“EGFR”) mutated NSCLC.
Cancer Immunization Programs
BNT116 is based on BioNTech’s FixVac platform and is a proprietary, systemically administered, and commercially available cancer vaccine candidate based on uridine mRNA lipoplex encoding six shared antigens linked to lung cancer. BNT116 is being evaluated for the treatment of complex NSCLC.
Autogene cevumeran (BNT122) is a uridine-based mRNA-based cancer vaccine and lipoplex for individualized neoantigen-specific immunotherapy (“iNeST”) that is being developed in collaboration with Genentech, Inc. (“Genentech”), a member of the Roche Group. (“Roche”).
Cell Therapy Programs
BNT211 is a forged tumor (CLDN6) Claudin-6 (“CLDN6”) mobile product candidate in mixture with a CAR-T mobile enhancer RNA vaccine (“CARVac”) encoding CLDN6.
Some Highlights of the Infectious Disease Portfolio
Beyond BioNTech’s portfolio of combined, next-generation, variant-tailored respiratory programs, the company is developing vaccine modalities against pathogens that pose a public health risk and constitute a significant global health burden.
In 2023, BioNTech filed its first 3 Phase 1 human clinical trials leveraging its proprietary prophylactic mRNA vaccine technology. These trials include vaccine applicants for shingles, tuberculosis (Germany) and NCT05547464 (Republic of South Africa) and mpox).
Company Update for 2023 and Key Post-Period EventsIn 2023, BioNTech strategically has a number of complementary agreements and collaborations, including:
Over the past 12 months, BioNTech has expanded its organization to Asia, Africa, North America, Australia and Europe. The company has enhanced its research, development and production functions and completed the structure of its first proprietary plasmid DNA production facility in Marburg, Germany. . BioNTech also delivered the first BioNtainer for its facility in Kigali, Rwanda.
In February 2024, BioNTech entered into a strategic collaboration with Autolus Therapeutics plc (“Autolus”) to advance both companies’ autologous CAR-T systems toward commercialization, pending regulatory approvals. The collaboration also gives BioNTech the ability to access a set of target binders. and mobile programming technologies from Autolus to BioNTech’s progression of in vivo mobile therapeutics and ADC candidates.
In March 2024, BioNTech announced that Sean Marett, Chief Commercial and Commercial Officer, would be retiring from BioNTech’s board of directors as planned. Effective July 1, 2024, Sean Marett will continue to serve as a company advisory until at least the end of the year. As announced today, Annemarie Hanekamp will join the company’s board of directors as Chief Commercial Officer on July 1, 2024. Sean Marett’s day-to-day jobs as a business director are gradually transferring to James Ryan, Ph. D. . , General Counsel, who joined the Executive Board in September 2023 and will also assume the role of Chief Commercial Officer of BioNTech following the final touch of the transition phase and the retirement of Sean Marett.
Environmental, Social and Governance (ESG)
In February 2024, the Company’s short-term, science-based emissions reduction targets were approved through the Science Based Targets press on February 12, 2024.
BioNTech’s environmental, social and governance (ESG) functionality is assessed through external rating agencies. The Institutional Shareholder Services Group (“ISS”) recently assigned BioNTech a “Prime” ESG rating: the company earned an overall corporate rating of B-, a rating that is among the most sensible 10% in the pharmaceutical and biotech sector. In the ISS Governance Quality Score, BioNTech scores five on a threat scale ranging from 1 (low threat) to 10 (high threat).
Today, March 20, 2024, BioNTech publishes its 2023 Sustainability Report. The report is available on the Investors segment of BioNTech’s website.
Upcoming Events for Investors and Analysts
Conference Call and Webcast Information
BioNTech invites investors and the general public to participate in a telephone and webcast convention with investment analysts today, March 20, 2024, at 8:00 a. m. m. ET (1:00 p. m. CET) to present its monetary effects and offer a fourth quarter. Corporate Update. Quarter and fiscal year 2023.
To access the live convention call by phone, log in to this link. Once you’re logged in, you’ll be provided with dial-in numbers and a PIN code.
The slideshow and audio of the webcast will be available through this link.
Participants may also access the convention slides and webcast through the “Events & Presentations” page in the Investors segment of the Company’s online page on https://biontech. com. A replay of the webcast may be made as long as it is after the call is held and archived on the Company’s website for 30 days following the call.
About BioNTechBiopharmaceutical New Technologies (BioNTech) is a global next-generation immunotherapy company pioneering cutting-edge treatments for cancer and other serious diseases. BioNTech leverages a wide diversity of computational discovery platforms and curative drugs for the immediate progression of new biopharmaceuticals. Its broad portfolio of oncology product applicants include individualized and commercially available mRNA-based treatments, cutting-edge chimeric antigen receptor (CAR) T cells, protein-based therapeutics that add bispecific immune checkpoint modulators, targeted cancer antibodies, and antibody-drug conjugates (ADCs). as well as small molecules. Drawing on its deep expertise in mRNA vaccine progression and in-house production capabilities, BioNTech and its collaborators are submitting applicants for mRNA vaccines for a variety of infectious diseases, across its diverse oncology portfolio. BioNTech has established a wide variety of relationships with a number of global companies. and specialized pharmaceutical collaborators, adding Biotheus, DualityBio, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, OncoC4, Pfizer and Regeneron.
For more information, visit www. BioNTech. com.
Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, among others, statements relating to: BioNTech’s expected revenues and net source of revenues similar to that of BioNTech. COVID-19 sales. 19, called COMIRNATY when approved for use under full or conditional market positioning authorization, in territories controlled through BioNTech collaboration partners, specifically for figures derived from initial estimates provided through BioNTech collaboration partners. BioNTech; the rate and degree of acceptance of the market position of BioNTech’s COVID-19 vaccine and, if approved, BioNTech’s investigational medicines; expectations regarding expected adjustments in demand for COVID-19 vaccines, adding adjustments to the ordering environment and expected regulatory recommendations to adapt vaccines to respond to new variants or sublineages; the initiation, timing, progress, effects and burden of BioNTech’s studies and progression programs, including those related to additional formulations of BioNTech’s COVID-19 vaccine, and existing and long-standing preclinical studies and clinical trials BioNTech’s term, adding statements related to the timing of the launch, contracting and completion of the relevant studies or trials and preparatory tables and the availability of effects, as well as the schedule and final results of the regulatory approval programs and positioning authorizations in the market; BioNTech’s expectations related to its intellectual property; the validity of BioNTech’s collaboration and licensing agreements and its acquisition of InstaDeep Ltd. ; the progression, nature and feasibility of sustainable vaccine production and sourcing solutions; and BioNTech’s estimates of revenue, study and progression expenses, sales charges, general and administrative expenses, and capital expenditures for operating activities. In certain cases, forward-looking statements may be referred to by terminology such as “will,” “may,” “deserve,” “expect,” “intend,” “plan,” “target,” “anticipate,” “believe. ” ”, “estimates”, “predicts”, “potential”, “continues” or the negative of those terms or other comparable terminology, although not all forward-looking statements involve those words. The forward-looking statements included in this press release are neither promises nor guarantees, and you should not place undue reliance on such forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond the control of BioNTech and may cause actual effects to differ materially from those expressed or implied by such forward-looking statements.
These dangers and uncertainties include, but are not limited to: BioNTech’s negotiations over pricing and policies related to its COVID-19 vaccine with government authorities, personal fitness insurers and other third-party payors following BioNTech’s initial sales to national governments; long-term advertising demand and medical demand for initial or booster doses of a COVID-19 vaccine; festival of other COVID-19 vaccines or similar to other applicants for BioNTech products, adding those with other mechanisms of action and other production and distribution limitations, based, among other things, on effectiveness, cost of the set, convenience of storage and distribution, the scope of approved use. , profile of effects of appearance and duration of the immune response; the timing and ability of BioNTech to discharge and maintain regulatory approval for BioNTech’s product applicants; the ability of BioNTech’s COVID-19 vaccines to rescue COVID-19 caused by emerging virus variants; The ability of BioNTech and its counterparties to manage and acquire mandatory energy resources; BioNTech’s ability to identify study opportunities and detect and expand investigational drugs; the ability and willingness of BioNTech’s external collaborators to pursue progression studies and activities similar to BioNTech’s progression and investigational drug applicants; the effect of the COVID-19 pandemic on BioNTech’s progression programs, supply chain, personnel and financial performance; unforeseen protection issues and potential claims arising from the use of the BioNTech COVID-19 Vaccine and other products and product applicants developed or manufactured through BioNTech; The ability of BioNTech and its collaborators to advertise and publicize BioNTech’s COVID-19 vaccine and, if approved, its product applicants; BioNTech’s ability to manage its progression and expansion; regulatory progressions in the United States and other countries; BioNTech’s ability to successfully scale its manufacturing functions and manufacture its products, adding targeted production grades of COVID-19 vaccines and product applicants; similar dangers to the monetary formula and global markets; and other points unknown to BioNTech at this time.
You deserve the dangers 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 BioNTech’s upcoming filings with the SEC, found on the SEC’s website. https://www. sec. gov/. Sauf, if required by law, BioNTech disclaims any objective or duty to update or revise any forward-looking statements contained in this press release, whether as a result of new information, long-term developments or otherwise. These forward-looking statements are based on BioNTech’s existing expectations and speak only as of the date hereof.
CONTACTS
Investor RelationsVictoria Meissner, M. D. 1-617-528-8293Investors@biontech. de
Media RelationsJasmina Alatovic (0)6131 9084 1513Media@biontech. de
Income Statements
(1) Adjustments to prior year figures due to adjustments in the functional distribution of overhead, administrative and operating expenses.
Statements of Financial Position
Cash Flow Statements