VEGF-A

Continued oncology pipeline advancement with a strategic focus on two priority pan-tumor programs: next-generation immunomodulator BNT327, a bispecific antibody targeting PD-L1 and VEGF-A1, and mRNA cancer immunotherapies Presented multiple clinical updates across oncology pipeline underlining BioNTech’s combination strategy in oncology with first data presented for the novel combination of BNT327 plus antibody-drug conjugates (“ADCs”) Development and commercial preparation for a 2025/2026 season variant-adapted COVID-19 vaccine First quarter 2025 revenues of €0.2 billion2, net loss of €0.4 billion and basic and diluted loss per share of €1.73 ($1.823) Maintained strong financial position with €15.9 billion in cash, cash equivalents and security investments as of March 31, 20254 Full year 2025 financial guidance confirmed Conference call and webcast scheduled for May 5, 2025, at 8:00 a.m. EDT (2:00 p.m. CEST) MAINZ, Germany, May 5, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today reported financial results for the three months ended March 31, 2025 and provided an update on its corporate progress. “In the first quarter of 2025, we demonstrated continued execution against our strategic focus areas, highlighted by data updates for our PD-L1xVEGF-A bispecific antibody candidate BNT327 and the progress in clinical evaluation of our focus programs and combination treatment approaches,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “We will continue to focus on our key strategic programs as we remain steadfast in our vision to translate our science into survival for patients in need.” Financial Review for First Quarter 2025 Revenues reported were €182.8 million for the three months ended March 31, 2025, compared to €187.6 million for the comparative prior year period. Revenues during the first quarter of 2025 were mainly driven by revenues derived from BioNTech’s COVID-19 vaccine collaboration. Cost of sales were €83.8 million for the three months ended March 31, 2025, compared to €59.1 million for the comparative prior year period. The change was mainly due to a positive impact of an inventory revaluation in the first quarter of 2024. Research and development (“R&D”) expenses were €525.6 million for the three months ended March 31, 2025, compared to €507.5 million for the comparative prior year period. The increase was mainly driven by progressing late-stage clinical studies for candidates in BioNTech’s ADC and antibody portfolio. Sales, general and administrative (“SG&A”) expenses5, in total, amounted to €120.6 million for the three months ended March 31, 2025, compared to €132.6 million for the comparative prior year period. The decrease was primarily driven by a reduction in external services. Income taxes were realized with an amount of €29.6 million in tax income for the three months ended March 31, 2025, compared to €16.7 million in realized tax income for the comparative prior year period. Net loss was €415.8 million for the three months ended March 31, 2025, compared to a net loss of €315.1 million for the comparative prior year period. Cash and cash equivalents plus security investments as of March 31, 2025, reached €15,854.4 million, comprising €10,184.9 million in cash and cash equivalents, €3,542.0 million in current security investments and €2,127.5 million in non-current security investments. Basic and diluted loss per share was €1.73 for the three months ended March 31, 2025, compared to a basic and diluted loss per share of €1.31 for the comparative prior year period. Shares outstanding as of March 31, 2025, were 240,392,622, excluding 8,159,578 shares held in treasury. “Our revenues for the first quarter reflect the seasonal demand for COVID-19 vaccines and are in line with our expectations,” said Jens Holstein, CFO of BioNTech. “BioNTech’s robust financial position empowers us to pursue our strategic goal of evolving into a leading biotech company with multiple oncology products by 2030.” 2025 Financial Year Guidance Confirmed6 BioNTech expects its revenues for the full 2025 financial year to be in the range of €1,700 - €2,200 million and revenue phasing similar to 2024, primarily concentrated in the last three to four months, driving the full year revenue figure. The revenue guidance assumes: relatively stable vaccination rates, pricing levels and market share compared to 2024; estimated inventory write-downs and other charges by BioNTech’s collaboration partner Pfizer that negatively influence BioNTech’s revenues; anticipated revenues from a pandemic preparedness contract with the German government; and anticipated revenues from the BioNTech Group service businesses. Potential changes to the law or governmental policy, including tariffs and public health policy, and evolving public sentiment worldwide, could further negatively impact our anticipated revenues and expenses. Planned 2025 Financial Year Expenses and Capex BioNTech expects to continuously focus investments on R&D and scaling the business for late-stage development and commercial readiness in oncology, while remaining cost-disciplined. Strategic capital allocation will continue to be a key driver of the Company’s trajectory. As part of BioNTech’s strategy, the Company may continue to evaluate appropriate corporate development opportunities with the aim of driving sustainable long-term growth and create future value.The full interim unaudited condensed consolidated financial statements can be found in BioNTech’s Report on Form 6-K for the period ended March 31, 2025, filed today with the United States Securities and Exchange Commission (“SEC”) and available at www.sec.gov. Endnotes1 All abbreviations are compiled in an abbreviation directory at the end of this press release.2 All numbers in this press release have been rounded.3 Calculated applying the average foreign exchange rate for the three months ended March 31, 2025, as published by the German Central Bank (Deutsche Bundesbank).4 A settlement payment of $400 million related to a contractual dispute with the University of Pennsylvania is expected to be reflected in the Company’s second quarter 2025 financial results. In connection with this and another settlement with the National Institutes of Health (“NIH”), BioNTech expects to be reimbursed approximately $535 million by its collaboration partner during 2025 and 2026. Reimbursement payments have begun with the first payment received by BioNTech in the first quarter of 2025. 5 Sales, general and administrative expenses (“SG&A”) include sales and marketing expenses as well as general and administrative expenses.6 Financial guidance excludes external risks that are not yet known and/or quantifiable, including, but not limited to the effects of ongoing and/or future legal disputes and related activities, certain potential one-time effects and charges related to portfolio prioritization. It includes effects identified from licensing arrangements, collaborations or potential M&A transactions to the extent disclosed and may be subject to update. The Company does not expect to report a positive net income figure for the 2025 financial year. Operational Review for the First Quarter 2025, Key Post Period-End Events and 2025 Outlook Selected Oncology Pipeline Updates Next-Generation Immunomodulators BNT327, formerly also known as PM8002, is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization. In March 2025, at the European Lung Cancer Congress (“ELCC”), preliminary data from two Phase 2 clinical trials conducted in China in first-line extensive-stage small cell lung cancer (“ES-SCLC”) and second-line small cell lung cancer (“SCLC”) were presented. Preliminary data from the ongoing single-arm, open-label Phase 2 clinical trial (NCT05844150) evaluating BNT327 in combination with chemotherapy as a first-line treatment in patients with ES-SCLC showed anti-tumor activity and an acceptable safety profile with no new safety signals beyond those typically described for chemotherapy agents and anti-PD-(L)1 and anti-VEGF monotherapies. These data were the first presented for BNT327 as a potential first-line treatment in ES-SCLC supporting the ongoing global randomized Phase 3 clinical trial ROSETTA Lung-01 (NCT06712355). Preliminary data from the ongoing Phase 2 clinical trial (NCT05879068) evaluating BNT327 in combination with chemotherapy as a second-line treatment in patients with SCLC showed anti-tumor activity, which was observed regardless of prior immuno-oncology treatment, and an acceptable safety profile. In April 2025, at the American Association for Cancer Research (“AACR”) Annual Meeting 2025, first data were presented for the novel combination of the PD-L1xVEGF-A bispecific antibody candidate BNT327 with various ADC candidates. Interim data from the ongoing Phase 1/2 clinical trial (NCT05438329) evaluating BNT327 with BNT325/DB-1305, a TROP2-targeting ADC candidate being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”), in patients with advanced/metastatic solid tumors showed a manageable safety profile and early signs of anti-tumor activity in a cohort with patients with platinum-resistant ovarian cancer (“PROC”). Across the 13 efficacy evaluable patients with PROC, seven patients achieved partial response and three stable disease. Responses were also observed in patients with non-small cell lung cancer (“NSCLC”) or triple-negative breast cancer (“TNBC”). Preliminary data from the ongoing single-arm, open-label Phase 2 clinical trial (NCT05844150) evaluating BNT327 in combination with chemotherapy as a first-line treatment in patients with ES-SCLC showed anti-tumor activity and an acceptable safety profile with no new safety signals beyond those typically described for chemotherapy agents and anti-PD-(L)1 and anti-VEGF monotherapies. These data were the first presented for BNT327 as a potential first-line treatment in ES-SCLC supporting the ongoing global randomized Phase 3 clinical trial ROSETTA Lung-01 (NCT06712355). Preliminary data from the ongoing Phase 2 clinical trial (NCT05879068) evaluating BNT327 in combination with chemotherapy as a second-line treatment in patients with SCLC showed anti-tumor activity, which was observed regardless of prior immuno-oncology treatment, and an acceptable safety profile. Interim data from the ongoing Phase 1/2 clinical trial (NCT05438329) evaluating BNT327 with BNT325/DB-1305, a TROP2-targeting ADC candidate being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”), in patients with advanced/metastatic solid tumors showed a manageable safety profile and early signs of anti-tumor activity in a cohort with patients with platinum-resistant ovarian cancer (“PROC”). Across the 13 efficacy evaluable patients with PROC, seven patients achieved partial response and three stable disease. Responses were also observed in patients with non-small cell lung cancer (“NSCLC”) or triple-negative breast cancer (“TNBC”). First data from an ongoing Phase 2 clinical trial (NCT05918107) in first-line mesothelioma and two trial-in-progress posters for the ongoing global Phase 3 and Phase 2/3 clinical trials, ROSETTA Lung-01 (NCT06712355) and ROSETTA Lung-02 (NCT06712316) respectively, will be presented at the American Society for Clinical Oncology (“ASCO”) Annual Meeting taking place from May 30 to June 3, 2025 in Chicago, Illinois. Abstract title: First report of efficacy and safety results from a Phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line treatment (1L) in unresectable malignant mesothelioma Abstract title: A global Phase III, double-blind, randomized trial of BNT327/PM8002 plus chemotherapy (chemo) compared to atezolizumab plus chemo in patients (pts) with first-line (1L) extensive-stage small cell lung cancer (ES-SCLC) Abstract title: A global Phase 2/3, randomized, open-label trial of BNT327/PM8002 in combination with chemotherapy (chemo) in first-line (1L) non-small cell lung cancer (NSCLC) mRNA Cancer Immunotherapies BNT116 is based on BioNTech’s fully owned, off-the-shelf FixVac platform, and is designed to elicit an immune response to six tumor-associated antigens that were identified to be frequently expressed in NSCLC. In April 2025, at the AACR Annual Meeting 2025, preliminary data from a cohort with frail patients were presented from the ongoing Phase 1 clinical trial LuCa-MERIT-1 (NCT05142189) evaluating BNT116 in combination with cemiplimab in patients with PD-L1 positive (TPS≥1%) unresectable Stage III or metastatic Stage IV NSCLC who are not eligible for chemotherapy as first-line treatment. The preliminary data showed anti-tumor activity, consistent immune response induction and a manageable safety profile. Antibody-Drug Conjugates BNT324/DB-1311 is an B7H3-targeted ADC candidate that is being developed in collaboration with DualityBio. The program has received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of patients with advanced castration-resistant prostate cancer (“CRPC”) whose disease has progressed while undergoing or after undergoing standard systemic regimens. In addition, the program has received Orphan Drug designation from the FDA for the treatment of patients with advanced esophageal squamous cell carcinoma. Preliminary data from the ongoing Phase 1/2 clinical trial (NCT05914116) evaluating BNT324/DB-1311 in patients with advanced solid tumors, including patients with previously treated castration-resistant prostate cancer (“CRPC”), will be presented at the 2025 ASCO Annual Meeting. Abstract title: DB‑1311/BNT324 (a novel B7H3 ADC) in patients with heavily pretreated castrate-resistant prostate cancer (CRPC) BNT325/DB-1305 is a TROP2-targeted ADC candidate that is being developed in collaboration with DualityBio. BNT325/DB-1305 received Fast Track designation from the FDA for the treatment of patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. In March 2025, at the Society of Gynecologic Oncology (“SGO”) Annual Meeting, preliminary data were presented from an ongoing Phase 1/2 clinical trial (NCT05438329) evaluating BNT325/DB-1305 in signal-seeking cohorts across various cancer indications, including PROC. The data from a cohort of patients with PROC showed a manageable safety profile and early signs of anti-tumor activity. Corporate and Commercial Update for the First Quarter 2025 Earlier today, BioNTech announced that the Supervisory Board has appointed Ramón Zapata-Gomez to the Management Board as Chief Financial Officer (“CFO”) effective July 1, 2025. He will join BioNTech from Novartis AG’s global biomedical research organization where he has been serving as CFO since 2022. Ramón Zapata will succeed Jens Holstein, who, as previously planned and announced, will retire at the end of his term on June 30, 2025. In February 2025, BioNTech completed the acquisition of Biotheus, obtaining full global rights to BNT327 and to all other candidates from Biotheus’ pipeline, as well as to its in-house antibody generation platform and bispecific ADC capability. The transaction amounted to an upfront consideration of $800 million, plus additional performance-based payments of up to $150 million. BioNTech and Pfizer developed, manufactured and delivered their JN.1 and KP.2-adapted COVID-19 vaccines, which have received multiple regulatory approvals, including full approvals, authorizations for emergency or temporary use, or marketing authorizations, in more than 40 countries and regions. BioNTech is now focused on preparing for variant strain vaccine adaptation to be ready for commercial launch ahead of the upcoming 2025/2026 vaccination season, pending approvals. Upcoming Investor and Analyst Events Annual General Meeting: May 16, 2025 Innovation Series R&D Day: November 11, 2025 Conference Call and Webcast Information BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, May 5, 2025, 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 2025. 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 section of the Company’s website at www.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 BioNTechBiopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron. For more information, please visit www.BioNTech.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech’s expected revenues and net profit/(loss) related to sales of BioNTech’s COVID-19 vaccine 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 BioNTech’s current and future preclinical studies and clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of studies or clinical trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations; BioNTech’s expectations regarding potential future commercialization in oncology, including goals regarding timing and indications; the targeted timing and number of additional potentially registrational clinical trials, and the registrational potential of any clinical trial BioNTech may initiate; discussions with regulatory agencies; BioNTech’s expectations with respect to intellectual property; the impact of BioNTech’s collaboration and licensing agreements; the development, nature and feasibility of sustainable vaccine production and supply solutions; the deployment of AI across BioNTech’s preclinical and clinical operations; BioNTech’s expectations with respect to tariff policy; BioNTech’s estimates of revenues, research and development expenses, selling, general and administrative expenses and capital expenditures for operating activities; BioNTech’s expectations regarding upcoming payments relating to litigation settlements; BioNTech’s expectations for upcoming scientific and investor presentations; and BioNTech’s expectations of net profit / (loss). 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 based on BioNTech’s current expectations and beliefs of future events, and are neither promises nor guarantees. 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 and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, projected data release timelines, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; BioNTech’s pricing and coverage negotiations regarding its COVID-19 vaccine with governmental authorities, private health insurers and other third-party payors; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; the impact of tariffs and escalations in trade policy; 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 its 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 COVID-19 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 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 related expenses; regulatory and political developments in the United States and other countries; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended March 31, 2025 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. CONTACTS Investor RelationsMichael HorowiczInvestors@biontech.de Media RelationsJasmina AlatovicMedia@biontech.de Target Overview Interim Condensed Consolidated Statements of Profit or Loss Interim Condensed Consolidated Statements of Financial Position Interim Condensed Consolidated Statements of Cash Flows

Seven months after the FDA approved the reintroduction of Roche's eye implant Susvimo, the US agency has expanded its approved use to include treatment for diabetic macular edema, the primary cause of blindness related to diabetes. This marks the second approved indication for Susvimo, which was initially cleared in October 2021 as an alternative to frequent eye injections for wet age-related macular degeneration. LAS VEGAS, April 30, 2025 /PRNewswire/ -- Diabetic macular edema is a complication that develops from diabetic retinopathy, a widespread consequence of diabetes and a leading cause of irreversible vision loss in working-age adults globally. Diabetic retinopathy occurs due to long-term damage to the retina's small blood vessels, leading to fluid leakage and swelling—especially in the macula. As per DelveInsight's analysis, there were about 1.9 million prevalent cases of DME across the 7MM in 2023, with numbers expected to grow at a notable CAGR during the forecast period. The primary treatment for DME includes intravitreal injections, where the eye is numbed with drops before injecting medication directly into the vitreous humor. Common anti-VEGF drugs used include AVASTIN, EYLEA, and LUCENTIS. Additionally, corticosteroids are beneficial in cases of DME linked to inflammatory eye conditions and can be delivered via eye drops, oral tablets, or periocular injections to help reduce inflammation. The US FDA approved sustained-release corticosteroid implants for more serious or longer-lasting conditions, are OZURDEX, RETISERT, and ILUVIEN. Learn more about the diabetic macular edema treatment @ New Treatment for Diabetic Macular Edema EYLEA (Regeneron Pharmaceuticals) – Aflibercept is a recombinant fusion protein composed of the VEGF-binding regions derived from the extracellular domains of human VEGF receptors 1 and 2, linked to the Fc segment of human IgG1. It functions as a VEGF trap by binding to circulating vascular endothelial growth factors (VEGFs), thereby neutralizing VEGF-A, VEGF-B, and placental growth factor (PGF). This action inhibits the formation of new blood vessels in the tumor's choriocapillaris. In July 2014, the U.S. FDA approved EYLEA (aflibercept) Injection for treating diabetic macular edema (DME). Ranibizumab (Genentech) – Marketed as LUCENTIS, ranibizumab is a monoclonal antibody fragment (Fab) derived from the same original mouse antibody as bevacizumab. It is an anti-angiogenic therapy used to treat the "wet" form of age-related macular degeneration (AMD), a leading cause of vision loss in older adults. Ranibizumab has shown comparable effectiveness to bevacizumab. Developed by Genentech, it is marketed in the U.S. by Genentech and internationally by Novartis. The FDA approved ranibizumab for the treatment of DME in 2012. In February 2025, Roche announced that the FDA had approved Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic macular edema (DME), a major cause of vision loss in adults with diabetes. This approval is based on positive one-year data from the phase III Pagoda trial, which demonstrated that Susvimo offered sustained improvements in vision for individuals with DME, with a safety profile consistent with what is already known for the drug. In the study, patients receiving Susvimo refills every six months experienced vision gains comparable to those receiving monthly intravitreal injections of 0.5 mg ranibizumab (9.6 letters versus 9.4 letters on an eye chart, equivalent to about two lines of vision improvement). Susvimo delivers a specially formulated version of ranibizumab continuously through the Port Delivery Platform, offering a less frequent dosing alternative compared to other treatments that may require monthly eye injections. The FDA initially approved Susvimo in 2021 for the treatment of neovascular age-related macular degeneration (nAMD). Regulatory reviews in other countries are currently underway. Learn more about the FDA-approved DME drugs @ Drugs for Diabetic Macular Edema Treatment Key players, such as Oculis, Rezolute, AsclepiX Therapeutics, and others, are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of diabetic macular edema. The DME market has a promising outlook with the emerging therapies. Some of the drugs in the pipeline are OCS-01, RZ402, AXT107, and others. DME leads to significant vision loss in diabetics, affecting up to 7.9% of type 1 and 12.8% of type 2 diabetes patients. AbbVie, in collaboration with REGENEXBIO, is developing the gene therapy ABBV-RGX-314. This therapy targets wet age-related macular degeneration, diabetic retinopathy (DR), and other chronic retinal diseases, potentially offering a breakthrough in treating these conditions. Discover which therapies are expected to grab major DME market share @ Diabetic Macular Edema Market Report OCS-01 is a high-concentration dexamethasone eye drop developed for diabetic macular edema (DME), utilizing the proprietary Optireach solubilizing platform. This technology enhances drug solubility, allows for higher concentrations, prolongs ocular retention, and improves bioavailability in eye tissues, including the retina. Recently, in April 2025, Oculis announced the completion of patient enrollment for its Phase 3 DIAMOND-1 and DIAMOND-2 clinical trials evaluating OCS-01 eye drops for diabetic macular edema (DME). These pivotal registration studies aim to support global regulatory filings, including a New Drug Application (NDA) submission and potential approval by the U.S. FDA. Over 800 patients were enrolled across 119 sites in the U.S. and other countries. The swift completion of enrollment in the DIAMOND program—comprising two double-masked, randomized, multi-center Phase 3 trials—is a significant milestone. These studies are assessing the efficacy and safety of OCS-01 over a 52-week treatment period in patients with DME. Topline results are anticipated in Q2 2026, followed by an NDA submission. If approved, OCS-01 would be the first topical eye drop treatment for DME, offering a novel therapeutic option for early intervention and for patients who do not adequately respond to anti-VEGF therapies. RZ402 is an oral small-molecule drug that selectively inhibits plasma kallikrein (PK) for the long-term treatment of DME. By blocking kallikrein activation, RZ402 aims to prevent bradykinin-driven vascular leakage and inflammation. Phase II results revealed a significant reduction in central subfield thickness (CST) across all dosing levels, with improvements of up to ~50 microns compared to placebo. The treatment was well tolerated and showed a favorable safety profile. AXT107 targets two validated mechanisms for treating retinal vascular diseases: it inhibits the pro-angiogenic receptor VEGFR2 and activates the vessel-stabilizing Tie2 receptor. These effects are mediated through its interaction with integrins αvβ3 and α5β1. AXT107 is formulated as a microparticulate suspension designed for intraocular injection and is currently undergoing Phase I/II clinical trials, according to the company's development pipeline. Discover more about drugs for DME in development @ Diabetic Macular Edema Clinical Trials The anticipated launch of these emerging therapies for DME are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the DME market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for DME is expected to grow from USD 3 billion in 2023, with a significant CAGR by 2034. Owing to the higher patient pool and higher diabetic macular edema treatment cost, according to the estimates, the United States had the highest market size in DME, i.e., ~60% of the total market size of DME in the 7MM, in 2023, followed by Germany and Japan. DelveInsight's analysis forecasts market growth due to the introduction of emerging therapies, expecting a rise in market size during the study period (2020–2034). The anticipated increase in market size is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies. DelveInsight's latest published market report, titled as Diabetic Macular Edema Market Insight, Epidemiology, and Market Forecast – 2034 , will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the DME country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The DME market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of DME Total Diagnosed Prevalent Cases of DME Gender-specific Diagnosed Prevalent Cases of DME Age-Specific Diagnosed Prevalent Cases of DME Subgroup-specific Diagnosed Prevalent Cases of DME The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM DME market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this DME market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the DME market. Also, stay abreast of the mitigating factors to improve your market position in the DME therapeutic space. Related Reports Diabetic Macular Edema Epidemiology Forecast Diabetic Macular Edema Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted diabetic macular edema epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Diabetic Macular Edema Pipeline Diabetic Macular Edema Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key diabetic macular edema companies, including Mylan Pharmaceuticals, Kodiak Sciences, Celltrion, Exonate, Opthea, AsclepiX Therapeutics, Allgenesis Biotherapeutics, Ascentage Pharma, Rezolute, Ocuphire Pharma, Oxurion, MingSight Pharmaceuticals, Adverum Biotechnologies, among others. Diabetic Retinopathy Market Diabetic Retinopathy Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key diabetic retinopathy companies, including Genentech, Inc., Regeneron Pharmaceuticals, Roche, Opthea Limited, Regenxbio, Kodiak Sciences Inc, Ocuphire Pharma, Eisai Co Ltd, Apexian Pharmaceuticals, Oculis, among others. Diabetic Retinopathy Pipeline Diabetic Retinopathy Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key diabetic retinopathy companies, including Kodiak Sciences, Novartis, Regenxbio Inc., OcuTerra Therapeutics, Ocular Therapeutix, Bayer, RemeGen, Roche, Ocuphire Pharma, Adverum Biotechnologies, Boehringer Ingelheim, Palatin Technologies, Valo Health, EyePoint Pharmaceuticals, Kubota Vision, MingSight Pharmaceuticals, Oxurion, Aerie Pharmaceuticals, AsclepiX Therapeutics, Ocugen, Ashvattha Therapeutics, Stealth BioTherapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Initial real-world data from nearly 40,000 EYLEA HD patients will provide early insights on effectiveness of EYLEA HD in everyday clinical practice New indirect comparisons will evaluate EYLEA HD and faricimab on measures of efficacy, dosing frequency and potential economic benefits in patients with wet age-related macular degeneration and diabetic macular edema TARRYTOWN, N.Y., April 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the upcoming presentation of 27 abstracts, including eight oral presentations on EYLEA HD® (aflibercept) Injection 8 mg in wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). Among the new results and analyses are initial insights on the real-world use of EYLEA HD in clinical practice, which reinforce the outcomes seen in pivotal trials. These data will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting from May 4 to 8 in Salt Lake City. "Our data presentations at ARVO reflect the robust and rapidly growing body of evidence that support the use of EYLEA HD becoming the new standard of care for people living with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy,” said Boaz Hirshberg, M.D., Senior Vice President, Clinical Development, Internal Medicine at Regeneron. “This includes new analyses examining the initial real-world experiences of nearly 40,000 patients treated with EYLEA HD showing, in everyday clinical practice, a positive impact through improved vision and longer dosing intervals for patients. Although early, these data reinforce the value EYLEA HD is bringing to patients with serious retinal diseases.” Notable new presentations at ARVO include: Four analyses evaluating initial real-world experiences with EYLEA HD among patients with wAMD or DME, including both those who were previously naive to treatment and those who switched from other anti-vascular endothelial growth factor (VEGF) therapiesA network meta-analysis indirectly comparing the efficacy and number of injections received for EYLEA HD and faricimab in patients with DME or wAMD, based on the longest follow-up data from Phase 3 clinical trialsA modeling analysis of the potential economic benefit of EYLEA HD compared to faricimab for the treatment of patients with wAMD or DME in the U.S. over three years The most common adverse reactions (≥3%) reported in patients treated with EYLEA HD were cataract, conjunctival hemorrhage, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect and retinal hemorrhage. Key EYLEA HD presentations at ARVO: Abstract titleLead author Presentation date, time (MST), locationEarly insights on the real-worlduse of aflibercept 8 mg amongtreatment-naive eyes withdiabetic macular edemaNitish Mehta, MDPoster PresentationDate: May 5Time: 3:00–4:45 PM MSTSession: Diabetic Macular Edema: Anti-VEGFEarly insights from real-worlduse of aflibercept 8 mg amongeyes with diabetic macularedema (DME) switching fromother anti-VEGF agentsMichael Javaheri, MDPoster PresentationDate: May 5Time: 3:00–4:45 PM MSTSession: Diabetic Macular Edema: Anti-VEGFEconomic benefit of aflibercept8 mg versus faricimab in thetreatment of patients withneovascular age-relatedmacular degeneration (nAMD)or diabetic macular edema(DME) in the United StatesAndreas KuznikPaper PresentationDate: May 5Time: 4:00–4:15 PM MSTSession: Economic Impact of AI Tools and TreatmentsEarly real-world use ofaflibercept 8mg in treatment-naïve patients with neovascularage-related maculardegenerationFerhina Ali, MDPoster PresentationDate: May 6Time: 8:30–10:15 AM MSTSession: AMD 2 (anti-VEGF)Early insights from real-worlduse of aflibercept 8mg amongeyes with neovascular age-related macular degeneration(nAMD) switching from otheranti-VEGF agentsTheodore Leng, MDPoster PresentationDate: May 6Time: 8:30–10:15 AM MSTSession: AMD 2 (anti-VEGF)Network meta-analyses (NMAs)of number of injections (NoI)with high-dose (HD) aflibercept(AFL) versus faricimab (FAR) inpatients with diabetic macularedema (DME) and neovascularage-related maculardegeneration (nAMD)Steven ShermanPoster PresentationDate: May 8 Time: 8:00–9:45 AM MSTSession: Telemedicine, Health Service Delivery and Health Economic StudiesVolumetric fluid assessmentcomparing high-dose afliberceptto standard dose aflibercept inneovascular age-relatedmacular degeneration in theCANDELA phase 2 trialJohn Mamone, MDPoster Presentation Date: May 4 Time: 1:00–2:45 PM MSTSession: AMD 1 (Clinical Research)PULSAR extension: clinicalimprovements maintained over156 weeks with aflibercept 8 mgin patients with neovascularage-related maculardegeneration*Timothy Lai, MDPaper PresentationDate: May 4Time: 1:00–1:15 PM MSTSession: AMD antiVEGF IA PULSAR phase 3 trial post-hoc analysis: evaluating thetiming and magnitude of controlof disease activity withaflibercept 8 mg and faricimab,applying similar disease activitycriteria across different pivotalPhase 3 trials for nAMD*Jean-Francois Korobelnik, MDPaper PresentationDate: May 4Time: 1:15–1:30 PM MSTSession: AMD antiVEGF ISPECTRUM: early clinicalexperience from the first globalreal-world study of aflibercept 8mg in patients with treatment-naïve neovascular age-relatedmacular degeneration*Vasileois Konidaris, MDPaper PresentationDate: May 4Time: 1:30–1:45 PM MSTSession: AMD antiVEGF ISPECTRUM: early clinicalexperience from the first globalreal-world study of aflibercept 8mg in patients with pretreatedneovascular age-relatedmacular degeneration*Clare Bailey, MDPaper PresentationDate: May 5Time: 3:00–3:15 PM MSTSession: AMD antiVEGF IIAflibercept 8 mg in diabeticmacular edema: 156-weekresults from the PHOTONextension studyGhassan Ghorayeb, MDPoster PresentationDate: May 5Time: 3:00–4:45 PM MSTSession: Retina: Physiology and PharmacologyIntraocular pressure outcomeswith aflibercept 8 mg and 2 mgin patients with diabetic macularedema through week 96 of thephase 2/3 PHOTON trialAnita Barikian, MDPoster PresentationDate: May 5 Time: 3:00–4:45 PM MSTSession: Diabetic Macular Edema: Anti-VEGFDifferential anatomic responseto aflibercept 8 mg versus 2 mgduring the matched dosingphase of the PHOTON trial inpatients with diabetic macularedema who subsequently metcriteria for shorteningDilsher Dhoot, MDPoster PresentationDate: May 5Time: 3:00–4:45 PM MSTSession: Diabetic Macular Edema: Anti-VEGFSPECTRUM: early clinicalexperience from the first globalreal-world study of aflibercept 8mg in patients with treatment-naïve diabetic macular edema*Aires Lobo, MDPoster PresentationDate: May 5Time: 3:00–4:45 PM MSTSession: Diabetic Macular Edema: Anti-VEGFSPECTRUM: early clinicalexperience from the first globalreal-world study of aflibercept 8mg in patients with pretreateddiabetic macular edema*Thomas Dervos, MDPoster Presentation:Date: May 5Time: 3:00–4:45 PM MSTSession: Diabetic Macular Edema: Anti-VEGFRapid fluid resolution withaflibercept 8 mg may beassociated with extended dosingintervals at W96 in nAMD: aPULSAR post-hoc analysis*Michael Stewart, MDPoster PresentationDate: May 6Time: 8:30–10:15 AM MSTSession: AMD 2 (anti-VEGF)Greater and more durable fluidresolution with aflibercept 8 mgversus aflibercept 2 mg in thePULSAR trial: a 96-week post-hoc analysis*Richard Gale, MDPoster PresentationDate: May 6Time: 8:30–10:15 AM MSTSession: AMD 2 (anti-VEGF)Clinical outcomes withaflibercept 8 mg and aflibercept2 mg are generally comparablein patients grouped by CNVtype: a post hoc analysis of the96-week PULSAR trial*Sobha Sivaprasad, MDPoster PresentationDate: May 6Time: 8:30–10:15 AM MSTSession: AMD 2 (anti-VEGF)A pooled analysis of theCANDELA, PHOTON, andPULSAR trials through 96weeks: comparably lowintraocular inflammation (IOI)-related events with aflibercept 8mg and 2 mg*Justus Garweg, MDPoster PresentationDate: May 6Time: 8:30–10:15 AM MSTSession: AMD 2 (anti-VEGF)Baseline characteristics andoutcomes of patients treatedwith aflibercept 8 mg atshortened, maintained, orextended dosing intervalsthrough 96 weeks in PHOTONMark Barakat, MDPaper PresentationDate: May 7Time: 11:15–11:30 AM MSTSession: Diabetic Macular Edema: Anti-VEGFWeek 96 outcomes inaflibercept 8 mg- and 2 mg-treated patients by prior DMEtreatment status: a subgroupanalysis of the phase 2/3PHOTON trialManjot Gill, MDPaper PresentationDate: May 7Time: 11:30–11:45 AM MSTSession: Diabetic Macular Edema: Anti-VEGFLower socioeconomic status isassociated with increasedbevacizumab use amongpatients initiating anti-vascularendothelial growth factor (anti-VEGF) therapy for diabeticmacular edema (DME)Judy Kim, MDPaper PresentationDate: May 7 Time: 11:45–12:00 PM MSTSession: Diabetic Macular Edema: Anti-VEGFA pooled analysis of thePULSAR and PHOTON trialsthrough 96 weeks: Minimalimpact of aflibercept 8 mg and 2mg on intraocular pressurechanges *Sergio Leal, MDPoster PresentationDate: May 8Time: 2:00–3:45 PM MSTSession: AMD 5 (Clinical Research) *Bayer-run trial About the EYLEA HD Clinical Trial Program PULSAR in wAMD and PHOTON in DME/diabetic retinopathy (DR) are double-masked, active-controlled pivotal trials that were conducted in multiple centers globally. In both trials, patients were randomized into 3 treatment groups to receive either: EYLEA HD every 3 months, EYLEA HD every 4 months, or EYLEA every 2 months. The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON. Patients treated with EYLEA HD in both trials had 3 initial monthly doses, and patients treated with EYLEA received 3 initial doses in PULSAR and 5 in PHOTON. In the first year, patients in the EYLEA HD groups could have their dosing intervals shortened down to an every 2-month interval if protocol-defined criteria for disease progression were observed. Intervals could not be extended until the second year of the trial. Patients in all EYLEA groups maintained a fixed 2-month dosing regimen throughout their participation in the two-year trials. In both trials, there was an optional extension study starting at week 96, with all participating patients receiving EYLEA HD through week 156. Patients initially randomized to EYLEA in PULSAR, were switched to EYLEA HD at the start of the extension study and immediately assigned to a 3-month dosing interval. Dosing intervals for all patients in the extension study could be shortened or extended by 2-week increments if protocol-defined criteria were met, with a minimum dosing interval of every 2 months and a maximum dosing interval of every 6 months. CANDELA was a Regeneron-sponsored Phase 2 trial investigating the safety and efficacy of EYLEA HD extended dosing regimens compared to EYLEA in wAMD patients. About wAMD and Diabetic Eye Disease wAMD is a retinal disease that may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This fluid can damage and scar the macula, which can cause vision loss. An estimated 1.4 million Americans have wAMD. DR is an eye disease characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. The disease generally starts as nonproliferative diabetic retinopathy (NPDR) and often has no warning signs or symptoms. NPDR may progress to proliferative diabetic retinopathy (PDR), a stage of the disease in which abnormal blood vessels grow onto the surface of the retina and into the vitreous cavity, potentially causing severe vision loss. DME can occur at any stage of DR as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment. In the U.S., approximately 1.5 million adults are diagnosed with DME, while approximately 6 million people have DR without DME. About EYLEA HD Over a decade ago, Regeneron introduced EYLEA, a vascular endothelial growth factor inhibitor, and transformed the treatment paradigm for certain serious chorioretinal vascular diseases. With a well-established efficacy and consistent safety profile from 16 pivotal trials, EYLEA is approved to treat vision-threatening conditions that impact patients from their earliest days, such as retinopathy of prematurity (ROP), to their later years, including diabetic macular edema (DME), diabetic retinopathy (DR), macular edema following retinal vein occlusion (RVO) and wet age-related macular degeneration (wAMD). Pushing the boundaries of science further to meet patient needs, EYLEA HD was developed to achieve comparable efficacy and safety to EYLEA, but with fewer injections. EYLEA HD is supported by a robust body of research and is currently approved in the U.S. to treat patients with wAMD, DME and DR. EYLEA HD (known as Eylea™ 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG. Regeneron maintains exclusive rights to EYLEA and EYLEA HD in the U.S. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of EYLEA and EYLEA HD. About Ophthalmology Development at Regeneron At Regeneron, we relentlessly pursue groundbreaking innovations in eye care science to help maintain the eye health of the millions of Americans impacted by vision-threatening conditions. Our expertise in angiogenesis and decades of research serve as our foundation, fueling our ongoing ambition to further innovate new solutions for patients. Our robust and diverse research and development program in ophthalmology includes efforts to potentially address additional serious eye diseases, including geographic atrophy (ongoing Phase 3 SIENNA clinical trial), glaucoma and certain inherited retinal diseases. IMPORTANT SAFETY INFORMATION AND INDICATIONS INDICATIONSEYLEA HD® (aflibercept) Injection 8 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). EYLEA® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Retinopathy of Prematurity (ROP) (0.4 mg). IMPORTANT SAFETY INFORMATION EYLEA HD and EYLEA are administered by injection into the eye. You should not use EYLEA HD or EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA HD or EYLEA, including aflibercept.Injections into the eye with EYLEA HD or EYLEA can result in an infection in the eye, retinal detachment (separation of retina from back of the eye) and, more rarely, serious inflammation of blood vessels in the retina that may include blockage. Call your doctor right away if you or your baby (if being treated with EYLEA for Retinopathy of Prematurity) experience eye pain or redness, light sensitivity, or a change in vision after an injection.In some patients, injections with EYLEA HD or EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection.In infants with Retinopathy of Prematurity (ROP), treatment with EYLEA will need extended periods of ROP monitoring.There is a potential but rare risk of serious and sometimes fatal side effects, related to blood clots, leading to heart attack or stroke in patients receiving EYLEA HD or EYLEA.The most common side effects reported in patients receiving EYLEA HD were cataract, increased redness in the eye, increased pressure in the eye, eye discomfort, pain, or irritation, blurred vision, vitreous (gel-like substance) floaters, vitreous detachment, injury to the outer layer of the eye, and bleeding in the back of the eye.The most common side effects reported in patients receiving EYLEA were increased redness in the eye, eye pain, cataract, vitreous detachment, vitreous floaters, moving spots in the field of vision, and increased pressure in the eye.The most common side effects reported in pre-term infants with ROP receiving EYLEA were separation of the retina from the back of the eye, increased redness in the eye, and increased pressure in the eye. Side effects that occurred in adults are considered applicable to pre-term infants with ROP, though not all were seen in clinical studies.You may experience temporary visual changes after an EYLEA HD or EYLEA injection and associated eye exams; do not drive or use machinery until your vision recovers sufficiently.For additional safety information, please talk to your doctor and see the full Prescribing Information for EYLEA HD and EYLEA. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please click here for full Prescribing Information for EYLEA HD and EYLEA. About RegeneronRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X. Forward-Looking Statements and Use of Digital MediaThis press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation EYLEA HD® (aflibercept) Injection 8 mg; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products (such as EYLEA HD) and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products (such as EYLEA HD) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection 2 mg), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). Contacts:Media RelationsJulie BlockTel: +1 914-826-7083julie.block@regeneron.comInvestor RelationsMark HudsonTel: +1 914-847-3482mark.hudson@regeneron.com