Dry Eye Syndromes

THOUSAND OAKS, Calif., May 1, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter of 2025. "Demand for our products was strong globally in the first quarter. Ongoing new product launches and successful Phase 3 trial results for several products make us feel confident in our long-term growth prospects," said Robert A. Bradway, chairman and chief executive officer. Key results include: For the first quarter, total revenues increased 9% to $8.1 billion in comparison to the first quarter of 2024. Product sales grew 11%, primarily driven by 14% volume growth, partially offset by 6% lower net selling price. U.S. sales grew 14%. Fourteen products delivered at least double-digit sales growth in the first quarter, including Repatha® (evolocumab), BLINCYTO® (blinatumomab), TEZSPIRE® (tezepelumab-ekko), EVENITY® (romosozumab-aqqg), TAVNEOS® (avacopan) and UPLIZNA® (inebilizumab-cdon). Our launch of IMDELLTRA ® (tarlatamab-dlle) generated $81 million of sales in the quarter and the Phase 3 confirmatory study demonstrated improved overall survival compared to chemotherapy. IMDELLTRA ® launched in Japan in April 2025. GAAP earnings per share (EPS) were $3.20 for the first quarter of 2025 compared with a GAAP loss per share of $0.21 for the first quarter of 2024, resulting from an unrealized gain on our BeiGene, Ltd. equity investment during the first quarter of 2025 compared to an unrealized loss during the prior year period, partially offset by an Otezla® intangible asset impairment charge of $800 million recorded during the first quarter of 2025. GAAP operating income increased from $1.0 billion to $1.2 billion, and GAAP operating margin increased 1.1 percentage points to 15.0%. Non-GAAP EPS increased 24% from $3.96 to $4.90, driven by higher revenues, partially offset by higher operating expenses. Non-GAAP operating income increased from $3.1 billion to $3.6 billion and non-GAAP operating margin increased 2.5 percentage points to 45.7%. The Company generated $1.0 billion of free cash flow in the first quarter of 2025 versus $0.5 billion in the first quarter of 2024. This increase reflects an $800 million tax deposit made in the first quarter of 2024 and current quarter business performance, partially offset by timing of working capital items and higher capital expenditures. References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented in the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion. Product Sales Performance General Medicine Repatha® (evolocumab) sales increased 27% year-over-year to $656 million in the first quarter, primarily driven by 41% volume growth, partially offset by 9% lower net selling price. EVENITY® (romosozumab-aqqg) sales increased 29% year-over-year to $442 million in the first quarter, driven by volume growth. Prolia® (denosumab) sales increased 10% year-over-year to $1.1 billion in the first quarter, primarily driven by 13% volume growth, partially offset by 5% lower net selling price. For 2025, we expect sales erosion driven by biosimilar competition, particularly in the second half of the year. Rare Disease TEPEZZA® (teprotumumab-trbw) sales decreased 10% year-over-year to $381 million in the first quarter, primarily driven by 9% lower volume and 8% from a decrease in inventory levels, partially offset by higher net selling price. KRYSTEXXA® (pegloticase) sales were flat year-over-year at $236 million in the first quarter, as 11% volume growth was offset by 10% from a decrease in inventory levels. UPLIZNA® (inebilizumab-cdon) sales increased 14% year-over-year to $91 million in the first quarter, primarily driven by volume growth. TAVNEOS® (avacopan) sales increased 76% year-over-year to $90 million in the first quarter, primarily driven by volume growth. Ultra-Rare products, which consist of RAVICTI® (glycerol phenylbutyrate), PROCYSBI® (cysteamine bitartrate), ACTIMMUNE® (interferon gamma-1b), BUPHENYL® (sodium phenylbutyrate) and QUINSAIR® (levofloxacin), generated $179 million of sales in the first quarter. Sales increased 6% year-over-year for the first quarter, driven by volume growth. Inflammation TEZSPIRE® (tezepelumab-ekko) sales increased 65% year-over-year to $285 million in the first quarter, driven by volume growth. Otezla® (apremilast) sales increased 11% year-over-year to $437 million in the first quarter, driven by 12% favorable changes to estimated sales deductions, as volume growth of 4% was offset by 5% lower net selling price. Enbrel® (etanercept) sales decreased 10% year-over-year to $510 million in the first quarter, driven by 47% lower net selling price resulting from increased 340B Program mix and higher commercial discounts, partially offset by 19% favorable changes to estimated sales deductions, higher inventory levels and volume growth. The year-over-year impact on net selling price is expected to be less pronounced in future quarters. AMJEVITA® (adalimumab-atto)/AMGEVITA™ (adalimumab) sales decreased 19% year-over-year to $136 million in the first quarter, primarily driven by 33% lower net selling price, partially offset by 11% volume growth. WEZLANA™ (ustekinumab-auub)/WEZENLA™ (ustekinumab) generated $150 million of sales in the first quarter. WEZLANA launched in the U.S. in the first quarter of 2025 and is the first FDA-approved biosimilar for the treatment of adult and pediatric plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. PAVBLU® (aflibercept-ayyh) generated $99 million of sales in the first quarter. PAVBLU launched in the U.S. in the fourth quarter of 2024 and is the first available aflibercept biosimilar for the treatment of retinal conditions, including neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. Oncology BLINCYTO® (blinatumomab) sales increased 52% year-over-year to $370 million in the first quarter, primarily driven by volume growth. Vectibix® (panitumumab) sales increased 8% year-over-year to $267 million in the first quarter, driven by volume growth. KYPROLIS® (carfilzomib) sales decreased 14% year-over-year to $324 million in the first quarter, driven by lower volumes due to increased competition. LUMAKRAS®/LUMYKRAS™ (sotorasib) sales increased 4% year-over-year to $85 million in the first quarter, driven by volume growth, partially offset by lower net selling price. XGEVA® (denosumab) sales increased 1% year-over-year to $566 million in the first quarter. For 2025, we expect sales erosion driven by biosimilar competition, particularly in the second half of the year. Nplate® (romiplostim) sales decreased 1% year-over-year to $313 million in the first quarter as volume growth was more than offset by unfavorable changes to estimated sales deductions and foreign exchange impact. IMDELLTRA® (tarlatamab-dlle)/IMDYLLTRA™ (tarlatamab) generated $81 million of sales in the first quarter. Sales increased 21% quarter-over-quarter driven by volume growth. MVASI® (bevacizumab-awwb) sales decreased 11% year-over-year to $179 million in the first quarter, primarily driven by lower volume. Going forward, we expect continued sales erosion driven by competition. Established Products Our established products, which consist of Aranesp® (darbepoetin alfa), Parsabiv® (etelcalcetide) and Neulasta® (pegfilgrastim), generated $557 million of sales in the first quarter. Sales decreased 3% year-over-year for the first quarter, driven by 10% lower net selling price and 3% unfavorable foreign exchange impact, partially offset by favorable changes to estimated sales deductions. Product Sales Detail by Product and Geographic Region Operating Expense, Operating Margin and Tax Rate Analysis On a GAAP basis: Total Operating Expenses increased 8% year-over-year for the first quarter. Cost of Sales as a percentage of product sales decreased 7.3 percentage points driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon and lower manufacturing costs, partially offset by changes in our sales mix. Research & Development (R&D) expenses increased 11% driven by higher spend in later-stage clinical programs, partially offset by lower spend in marketed product support and research and early pipeline. Selling, General & Administrative (SG&A) expenses decreased 7% driven by lower commercial product-related expenses and lower Horizon acquisition-related expenses, partially offset by higher general and administrative expenses. Other operating expenses consisted primarily of the Otezla® intangible asset impairment charge of $800 million. Operating Margin as a percentage of product sales increased 1.1 percentage points in the first quarter to 15.0%. Tax Rate increased 78.5 percentage points in the first quarter due to the change in earnings mix as a result of the first quarter 2025 unrealized gains compared to the first quarter 2024 unrealized losses on our equity investments, primarily BeiGene. On a non-GAAP basis: Total Operating Expenses increased 4% year-over-year for the first quarter. Cost of Sales as a percentage of product sales decreased 0.8 percentage points driven by lower manufacturing costs, partially offset by changes in our sales mix. R&D expenses increased 12% driven by higher spend in later-stage clinical programs, partially offset by lower spend in marketed product support and research and early pipeline. SG&A expenses decreased 3% driven by lower commercial product-related expenses, partially offset by higher general and administrative expenses. Operating Margin as a percentage of product sales increased 2.5 percentage points in the first quarter to 45.7%. Tax Rate decreased 0.8 percentage points in the first quarter due to the change in earnings mix and net favorable items as compared to the prior year. Cash Flow and Balance Sheet The Company generated $1.0 billion of free cash flow in the first quarter of 2025 versus $0.5 billion in the first quarter of 2024. This increase reflects an $800 million tax deposit made in the first quarter of 2024 and current quarter business performance, partially offset by timing of working capital items and higher capital expenditures. The Company declared a first quarter 2025 dividend on December 10, 2024 of $2.38 that was paid on March 7, 2025 to all stockholders of record as of February 14, 2025, representing a 6% increase from the same period in 2024. During the first quarter of 2025, the Company reduced principal debt outstanding by $2.8 billion. During the first quarter, there were no repurchases of shares of common stock. Cash and cash equivalents totaled $8.8 billion and debt outstanding totaled $57.4 billion as of March 31, 2025. 2025 Guidance For the full year 2025, the Company expects: Total revenues in the range of $34.3 billion to $35.7 billion. On a GAAP basis, EPS in the range of $12.21 to $13.46, and a tax rate in the range of 11.0% to 12.5%. On a non-GAAP basis, EPS in the range of $20.00 to $21.20, and a tax rate in the range of 14.5% to 16.0%. Capital expenditures to be approximately $2.3 billion. Share repurchases not to exceed $500 million. This guidance includes the estimated impact of implemented tariffs, but does not account for any tariffs that could be implemented in the future, including potential sector-specific tariffs. First Quarter Product and Pipeline Update The Company provided the following updates on selected product and pipeline programs: General Medicine MariTide (maridebart cafraglutide, AMG 133) MariTide is a differentiated peptide-antibody conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes the gastric inhibitory polypeptide receptor (GIPR). MARITIME-1, a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of maridebart cafraglutide is enrolling adults living with overweight or obesity, without Type 2 diabetes mellitus. MARITIME-2, a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of maridebart cafraglutide is enrolling adults living with overweight or obesity, with Type 2 diabetes mellitus. Planning for additional MARITIME Phase 3 studies across multiple indications remains on track, with additional studies expected to initiate throughout 2025. Part 2 of the Phase 2 chronic weight management study is ongoing in adults living with overweight or obesity, with or without Type 2 diabetes mellitus. Data readout is anticipated in H2 2025. A Phase 2 study investigating MariTide for the treatment of Type 2 diabetes mellitus has completed enrollment of adults living with and without obesity. Data readout is anticipated in H2 2025. AMG 513 A Phase 1 study of AMG 513 is enrolling people living with obesity following removal of the clinical hold by the U.S. Food and Drug Administration (FDA). Repatha VESALIUS-CV, a Phase 3 CV outcomes study of Repatha, is ongoing in patients at high CV risk without prior myocardial infarction or stroke. Data readout is event driven and anticipated in H2 2025. EVOLVE-MI, a Phase 4 study of Repatha administered within 10 days of an acute myocardial infarction to reduce the risk of CV events, is ongoing. Olpasiran (AMG 890) Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver. The OCEAN(a)-outcomes trial, a Phase 3 secondary prevention cardiovascular (CV) outcomes study, is ongoing in patients with atherosclerotic CV disease and elevated Lp(a). A Phase 3 CV outcomes study in patients with elevated Lp(a) and at high risk for a first CV event is expected to be initiated in H2 2025/H1 2026. Rare Disease TAVNEOS A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen, is enrolling patients from 6 years to < 18 years of age with active ANCA-associated vasculitis (Granulomatosis with Polyangiitis (GPA)/Microscopic Polyangiitis (MPA)). TEPEZZA Regulatory review is underway in multiple additional geographies, including with the European Medicines Agency (EMA), where approval is anticipated in H2 2025. A Phase 3 study of TEPEZZA in Japan is enrolling patients with chronic/low clinical activity score thyroid eye disease (TED). A Phase 3 study evaluating the subcutaneous route of administration of teprotumumab is enrolling patients with TED. UPLIZNA In April, the FDA approved UPLIZNA for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD) in adult patients. In April, data from the UPLIZNA Phase 3 MINT study in patients with generalized myasthenia gravis (gMG) were presented and simultaneously published in the New England Journal of Medicine. These data demonstrated durable and sustained efficacy of UPLIZNA treatment compared to placebo (adjusted difference, -1.8 at week 26; −2.8 at week 52) as measured by the change in baseline of Myasthenia Gravis Activities of Daily Living (MG-ADL) score in the acetylcholine receptor autoantibody-positive (AChR+) subpopulation through week 52. Among the AChR+ patients in the UPLIZNA group, 72% had a ≥3 point improvement in the MG-ADL score, compared to 45% in placebo at week 52. No new safety signals were identified. The FDA has accepted the regulatory submission of the MINT Phase 3 data with a PDUFA date of December 14, 2025. Dazodalibep Dazodalibep is a fusion protein that inhibits CD40L. Two Phase 3 studies of dazodalibep in Sjögren's disease are enrolling patients. The first study is in patients with moderate-to-severe systemic disease activity, and the second study is in patients with moderate-to-severe symptomatic burden and low systemic disease activity. Daxdilimab Daxdilimab is a fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7). A Phase 2 study of daxdilimab is ongoing in patients with moderate-to-severe active primary discoid lupus erythematosus refractory to standard of care. A Phase 2 study of daxdilimab is ongoing in patients with dermatomyositis and antisynthetase inflammatory myositis. Inflammation TEZSPIRE Two Phase 3 studies of TEZSPIRE were initiated and are enrolling adults with moderate to very severe chronic obstructive pulmonary disease (COPD) and a BEC ≥ 150 cells/µl. In March, data from the Phase 3 WAYPOINT study of TEZSPIRE in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) were presented and simultaneously published in the New England Journal of Medicine demonstrating that treatment with TEZSPIRE: significantly reduced Nasal Polyp Score (NPS) by -2.065 at week 52. significantly reduced nasal congestion (measured by participant-reported Nasal Congestion Score [NCS]) by -1.028 at week 52. Improvements in NPS were observed as early as week four, and NCS as early as week two, and were sustained through week 52. significantly reduced the need for nasal polyp surgery by 98%. significantly reduced the need for systemic corticosteroid treatment by 88%. had a safety profile consistent with its approved severe asthma indication. The FDA has accepted the regulatory submission of the WAYPOINT Phase 3 data with a PDUFA date of October 19, 2025. A Phase 3 study of TEZSPIRE is enrolling patients with eosinophilic esophagitis. Rocatinlimab (AMG 451/KHK4083) Rocatinlimab is a first-in-class T-cell rebalancing monoclonal antibody that inhibits and reduces OX40-positive pathogenic T-cells. The eight study ROCKET Phase 3 program evaluating rocatinlimab in patients with moderate-to-severe atopic dermatitis (AD) has enrolled over 3,300 patients. Enrollment is now complete in seven studies. In March, detailed data were presented from the ROCKET HORIZON Phase 3 study, which met its co-primary and all key secondary endpoints. In March, data were announced from three additional ROCKET program Phase 3 studies: The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints at week 24: 42.3% of patients in the higher dose group achieved ≥75% reduction from baseline in Eczema Area and Severity Index score (EASI-75), a 29.5% difference vs. placebo. In the lower dose group, 36.3% of patients achieved EASI-75, a 23.4% difference vs. placebo. 23.6% of patients in the higher dose group achieved a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline (vIGA-AD 0/1), a 14.9% difference vs. placebo. In the lower dose group, 19.1% of patients achieved this endpoint, a 10.3% difference vs. placebo. 22.7% of patients in the higher dose group achieved a revised Investigator's Global Assessment (rIGA™) score of 0/1 with a ≥2-point reduction from baseline (a more stringent measure of efficacy than vIGA-AD 0/1), a 14.4% difference vs. placebo. In the lower dose group, 16.3% of patients achieved this endpoint, an 8.0% difference vs. placebo. The SHUTTLE study, which evaluated two dose strengths of rocatinlimab in combination with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI), met its co-primary endpoints and all key secondary endpoints at week 24. The VOYAGER study, which successfully demonstrated that rocatinlimab does not interfere with responses to tetanus and meningococcal vaccinations. Across ROCKET program results to date, safety findings were generally consistent with the previously observed safety profile of rocatinlimab. The most frequent treatment-emergent adverse events (≥5%) with higher observed proportion in rocatinlimab groups were pyrexia, chills and headache. A higher number of patients receiving rocatinlimab vs. placebo experienced gastrointestinal ulceration events, with an overall incidence of less than 1%. Key upcoming milestones from the ROCKET Phase 3 program: ROCKET ASCEND is a study evaluating rocatinlimab maintenance therapy in adult and adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025. ROCKET ASTRO is a 52-week study evaluating rocatinlimab in adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025. A Phase 2 study of rocatinlimab is enrolling patients with moderate-to-severe asthma. A Phase 3 study of rocatinlimab is enrolling patients with prurigo nodularis (PN). Blinatumomab Blinatumomab is a bispecific T-cell engager (BiTE ®) molecule targeting CD19. A Phase 2 study of blinatumomab in autoimmune disease was initiated in adults with systemic lupus erythematosus (SLE). Inebilizumab Inebilizumab is a B-cell depleting monoclonal antibody targeting CD19. A Phase 2 study of inebilizumab in autoimmune disease was initiated in adults with SLE. AMG 104 (AZD8630) AMG 104 is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab). A Phase 2 study is enrolling patients with asthma. Oncology BLINCYTO / blinatumomab In April, the FDA granted Breakthrough Therapy Designation for subcutaneous blinatumomab in the treatment of adults with relapsed/refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL). A Phase 1/2 study of subcutaneous blinatumomab is ongoing in the dose-expansion and optimization phase in adult patients with relapsed or refractory Philadelphia chromosome (Ph)-negative B-ALL. The Company is planning to advance blinatumomab subcutaneous administration to a potentially registration-enabling Phase 2 portion of this study with initiation in H2 2025. Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, is enrolling older adult patients with newly diagnosed Ph-negative B-ALL. IMDELLTRA / tarlatamab IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE® molecule. In April, the Company announced that the global Phase 3 DeLLphi-304 study met its primary endpoint of improved overall survival at a planned interim analysis. This study evaluated IMDELLTRA compared to local standard-of-care chemotherapy as a treatment for patients with small cell lung cancer (SCLC) who progressed on or after a single line of platinum-based chemotherapy. The safety profile for IMDELLTRA was consistent with its known profile. Together these randomized data have the potential to establish IMDELLTRA as a new standard of care in second-line SCLC. Detailed data from DeLLphi-304 will be presented at the American Society of Clinical Oncology meeting (ASCO) in June. The Company is advancing a comprehensive, global clinical development program across extensive-stage and limited-stage SCLC: DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with PD-L1 alone, is ongoing in patients with first-line ES-SCLC. DeLLphi-305, a Phase 3 study of IMDELLTRA and durvalumab, is enrolling patients with first-line ES-SCLC in the maintenance setting. DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, is enrolling patients with limited-stage SCLC. DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab, is enrolling patients with second line or later ES-SCLC. DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens in second-line ES-SCLC, is enrolling patients. DeLLphi-310, a Phase 1b study, was initiated in patients with ES-SCLC evaluating IMDELLTRA in combination with YL201, a B7-H3 targeting antibody-drug conjugate, with or without anti-PD-L1. DeLLphi-312, a Phase 3 study of first-line IMDELLTRA with carboplatin, etoposide and durvalumab is planned to initiate in patients with ES-SCLC by mid-2025. Xaluritamig (AMG 509) Xaluritamig is a first-in-class BiTE® targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1). A Phase 3 study of xaluritamig is enrolling patients with metastatic castrate resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy. A Phase 1 study of xaluritamig monotherapy has completed enrollment of patients with mCRPC who have not yet received taxane-based chemotherapy and has also completed enrollment of patients with mCPRC who have previously received taxane-based chemotherapy in a fully outpatient treatment setting to further improve administration convenience. This study continues to enroll mCRPC patients into a combination treatment of xaluritamig and abiraterone. A Phase 1b study evaluating neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high–risk prostate cancer. A Phase 1b study of xaluritamig is enrolling patients with high-risk biochemically recurrent prostate cancer after definitive therapy. AMG 193 AMG 193 is a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor. A Phase 2 study evaluating the efficacy, safety, tolerability and pharmacokinetics of AMG 193 is enrolling patients with methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non-small cell lung cancer (NSCLC). A Phase 1/1b/2 study of AMG 193 is enrolling patients with advanced MTAP-null solid tumors in the dose-expansion portion of the study. A Phase 1b study of AMG 193 alone or in combination with other therapies is enrolling patients with advanced MTAP-null thoracic malignancies. A Phase 1b study of AMG 193 in combination with other therapies is enrolling patients with advanced MTAP-null gastrointestinal, biliary tract and pancreatic cancers. A Phase 1/2 study of AMG 193 in combination with IDE397, an investigational methionine adenosyltransferase 2A (MAT2A) inhibitor, will be discontinued following a wind-down period. Bemarituzumab Bemarituzumab is a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody. FORTITUDE-101, a Phase 3 study of bemarituzumab plus chemotherapy, is ongoing in patients with first-line gastric cancer. Data readout is anticipated in Q2 2025. FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab, is ongoing in patients with first-line gastric cancer. Phase 3 data readout is anticipated in H2 2025. FORTITUDE-103, a Phase 1b/2 study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab, is enrolling patients with first-line gastric cancer. FORTITUDE-301, a Phase 1b/2 basket study of bemarituzumab monotherapy, is ongoing in patients with solid tumors with FGFR2b overexpression. LUMAKRAS/LUMYKRAS CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI, is enrolling patients with first-line KRAS G12C–mutated CRC. CodeBreaK 202 (CB202), a Phase 3 study of LUMAKRAS plus chemotherapy vs. pembrolizumab plus chemotherapy, is enrolling patients with first-line KRAS G12C–mutated and PD-L1 negative advanced NSCLC. Nplate The final analysis of a Phase 3 study of Nplate as supportive care in chemotherapy-induced thrombocytopenia in gastrointestinal malignancies is complete. Data from this study will be presented at ASCO in June. Biosimilars A randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO® (nivolumab) has completed enrollment of patients with resected stage III or stage IV melanoma in the adjuvant setting. Data readout is anticipated in H2 2025. A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO is enrolling patients with treatment-naïve unresectable or metastatic melanoma. A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA® (pembrolizumab) is enrolling patients with early-stage non-squamous non-small cell lung cancer as adjuvant treatment. A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared to KEYTRUDA is enrolling patients with advanced or metastatic non-squamous non-small cell lung cancer. A randomized, double-blind pharmacokinetic similarity/comparative clinical study of ABP 692 compared to OCREVUS® (ocrelizumab) was initiated and is currently enrolling patients with relapsing-remitting multiple sclerosis. TEZSPIRE is being developed in collaboration with AstraZeneca. AMG 104 is being developed in collaboration with AstraZeneca. Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin. Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc. IDE397 is an investigational MAT2A inhibitor from IDEAYA Biosciences. YL201 is an investigational B7-H3 targeting antibody-drug conjugate being developed by MediLink. OPDIVO is a registered trademark of Bristol-Myers Squibb Company. KEYTRUDA is a registered trademark of Merck & Co., Inc. OCREVUS is a registered trademark of Genentech, Inc. Non-GAAP Financial Measures In this news release, management has presented its operating results for the first quarters of 2025 and 2024, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2025 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, divestitures, restructuring and certain other items from the related GAAP financial measures. Management has presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the first quarters of 2025 and 2024. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's normal and recurring business activities by facilitating comparisons of results of normal and recurring business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity. The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow us on X (formerly known as Twitter), LinkedIn, Instagram, YouTube and Threads. Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast), our acquisitions of ChemoCentryx, Inc. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. 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We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. CONTACT: Amgen, Thousand Oaks Elissa Snook, 609-251-1407 (media) Justin Claeys, 805-313-9775 (investors) Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as acquisitions, asset impairments, litigation, changes in fair value of our contingent consideration obligations and changes in fair value of our equity investments. The stated guidance also includes the estimated impact of implemented tariffs, but does not account for any tariffs that could be implemented in the future, including potential sector-specific tariffs. SOURCE Amgen WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

LONDON and NEW YORK, May 01, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing urcosimod (formerly called OK-101) to treat NCP, an ocular condition associated with chronic and often severe pain but without an FDA-approved therapy, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to urcosimod for the treatment of neuropathic corneal pain (NCP). Fast Track designation by the FDA is granted to facilitate the development and expedite the review of therapies that aim to treat serious conditions and fulfill unmet medical needs. This designation is intended to accelerate the availability of new treatments to patients, providing earlier access to potentially beneficial therapies. The Fast Track designation provides several key benefits, including more frequent meetings with the FDA to discuss the drug’s development plan, eligibility for Accelerated Approval and Priority Review if relevant criteria are met, and a potential Rolling Review of the New Drug Application (NDA). Neuropathic corneal pain is a debilitating condition characterized by persistent, severe eye pain caused by nerve damage, impacting a significant number of patients worldwide. OKYO Pharma's urcosimod aims to address this urgent medical need with its innovative approach. Gary S. Jacob, Ph.D., Chief Executive Officer of OKYO Pharma, expressed his enthusiasm about the FDA's decision: "We are thrilled with the FDA's Fast Track designation for urcosimod in the treatment of neuropathic corneal pain. This milestone underscores our commitment to advancing innovative therapies that can make a meaningful difference in patients' lives. We look forward to working closely with the FDA to bring this promising treatment to patients as quickly as possible." OKYO Pharma remains dedicated to advancing urcosimod through clinical development and regulatory review, with a focus on addressing the significant unmet medical need in neuropathic corneal pain treatment. About NCPNeuropathic corneal pain is a condition that causes severe pain and sensitivity of the eyes, face, or head. The exact cause of neuropathic corneal pain is unknown but is thought to result from nerve damage to the cornea combined with inflammation. Neuropathic corneal pain, which can exhibit as a severe, chronic, debilitating condition in patients suffering from a host of ophthalmic conditions, is presently treated by various topical and systemic treatments in an off-label fashion. Notably, there is no FDA approved drug to treat this debilitating condition. About the Urcosimod Phase 2 Trial in NCP PatientsThe Phase 2 study was designed as a double-masked, randomized, 12-week placebo-controlled trial in NCP patients, with disease confirmed via confocal microscopy. About Urcosimod (Formerly called OK-101)Urcosimod is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion. Urcosimod was developed using a membrane-anchored-peptide technology to produce a novel long-acting drug candidate for treating dry eye disease. Urcosimod has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and corneal neuropathic pain, respectively, and is designed to combat washout through the inclusion of the lipid anchor built into the drug molecule to potentially enhance the residence time of urcosimod within the ocular environment. Urcosimod showed clear statistical significance in multiple endpoints in a recently completed Phase 2, multi-center, double-masked, placebo-controlled trial to treat dry eye disease, and was also being evaluated in a randomized, placebo-controlled, double-masked Phase 2 trial to treat neuropathic corneal pain patients. About OKYOOKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain and dry eye disease, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and dry eye disease. In addition to the completed Phase 2 trial of urcosimod to treat dry eye disease patients, OKYO is also currently evaluating urcosimod to treat neuropathic corneal pain patients. For further information, please visit www.okyopharma.com. Enquiries: OKYO Pharma LimitedGary S. Jacob, Chief Executive Officer917-497-7560 Business Development & Investor RelationsPaul Spencer+44 (0)20 7495 2379

ZUG, Switzerland, May 01, 2025 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / ICX: OCS.IC) (“Oculis”), a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, today announced upcoming presentations highlighting its innovative late-stage pipeline at Eyecelerator 2025, the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting and the Retina World Congress (RWC). The presentation of the DME AWARE Delphi Study interim results will highlight key areas of consensus on unmet needs in DME patient management among leading global experts. Further insights from Stage 1 of the Phase 3 DIAMOND program reinforcing the efficacy and safety profile of OCS-01 eye drops for DME will also be shared. OCS-01 is being developed to be the first non-invasive treatment for DME, addressing key unmet needs for earlier treatment intervention and for inadequate responders to the current standard of care. Data from the Phase 2b RELIEF trial investigating Licaminlimab (OCS-02) in signs of DED will be presented following positive and consistent results from phase 2 trials in symptoms. The genetic biomarker, previously identified, to predict response to Licaminlimab, enables the first genotype-based development plan to drive a personalized approach in dry eye disease (DED). Licaminlimab is being developed to transform the treatment paradigm in DED, currently driven by trial and error, and address unmet medical needs for this multifactorial disease with a dissatisfied patient population. Details of the presentations are as follows: Eyecelerator 2025 Company showcases – Retina: TKI and Drug Delivery Presenter: Sharon Klier, M.D., Chief Development Officer Date/Time: Friday, May 2, 2025, 1:30 PM – 3:00 PM MST ARVO Annual Meeting 2025 Interim results of the DME AWARE Delphi Study on unmet needs in DME patient management Presenter: Anat Loewenstein, M.D., MHA Session: #261 Presentation: #2587 Posterboard: #B0300 Date/Time: Monday, May 5, 2025, 3:00 PM – 4:45 PM MSTBCVA and CST Improvement over 12 weeks with OCS-01 Eye Drops in DME from DIAMOND Stage 1 trial Presenter: Carl Danzig, M.D. Session: 401 Presentation: #4011 Location: Room #255ABC Date/Time: Wednesday, May 7, 2025, 10:15 AM – 12:00 PM MSTLicaminlimab in the treatment of dry eye disease Presenter: Anat Galor, M.D., MSPH Session: #513 Presentation: #5682 Posterboard: #B0077 Date/Time: Thursday, May 8, 2025, 8:00 AM – 9:45 AM MST Retina World Congress 2025 Wet AMD, DR, RVO – Part 2, Panel Discussion Participant: Riad Sherif, M.D., Chief Executive Officer Date/Time: Thursday, May 8, 2025, 11:25 AM – 11:59 AM ETBCVA and CST Improvement over 12 weeks with OCS-01 Eye Drops in DME From DIAMOND-Stage 1 trial Presenter: David Almeida, M.D., PhD Date/Time: Thursday, May 8, 2025, 6:08 PM – 6:13 PM ET Anat Loewenstein, M.D., MHA, is Professor and Head of Retina, Division of Ophthalmology Tel Aviv Medical Center, VP Ambulatory Services Tel Aviv Medical Center, Sidney Fox Chair of Ophthalmology at the Sackler Faculty of Medicine at Tel Aviv University, and President of the EURETINA. In addition to being a member of Oculis’ DIAMOND Steering Committee, Dr. Loewenstein serves as a member of Oculis’ Scientific Advisory Board. Her main field of interest is the investigation of drug administration and toxicity to the retina, early detection of macular degeneration and home monitoring of retinal disease. She currently serves as the Editor in Chief of the Journal Case Reports in Ophthalmology, is an associate editor of Investigative Ophthalmology & Visual Science Journal, European Journal of Ophthalmology, and of Ophthalmologica. Professor Loewenstein published more than 500 papers in peer reviewed journals and contributed multiple chapters to ophthalmology textbooks. She is also actively involved as a leader in mentorship programs for young retina specialists including the mentorship educational programs of ARVO and EURETINA. Carl Danzig, M.D., is the Director of Vitreoretinal Services and Retina Clinical Research at Rand Eye Institute in Deerfield Beach, FL, where he has been practicing since September 2011. In private practice, he founded the retina department at Rand Eye Institute and served as Principal Investigator in dozens of clinical trials. In addition, Dr. Danzig has frequently presented his research at various international ophthalmology meetings. He is also an Affiliate Assistant Professor of Clinical Biomedical Science at the Charles E. Schmidt School of Medicine at Florida Atlantic University in Boca Raton, FL. Recently, Dr. Danzig completely five years serving on the ONE network, retina division for the American Academy of Ophthalmology. Dr. Danzig spent his undergraduate years in New Orleans, LA at Tulane University, receiving a B.A. in Philosophy in 2000. He returned to his hometown for medical school at Temple University and stayed in Philadelphia for his internship along with a year of ocular oncology research at Wills Eye Hospital. Dr. Danzig completed his residency in ophthalmology at SUNY-Downstate Medical Center in Brooklyn, NY and went on to fellowship training in vitreoretinal surgery at University of Texas-Southwestern Medical Center in Dallas, TX. Anat Galor, M.D., is a cornea and uveitis trained specialist with a dual appointment at the Bascom Palmer Eye Institute and the Miami VA medical center. Dr. Galor completed an ophthalmology residency at the Cole Eye Cleveland Clinic, a uveitis fellowship at the Wilmer Eye Institute, and a cornea and external diseases fellowship at Bascom Palmer Eye Institute. Dr. Galor currently runs the ocular surface program at the Miami VA and has focused her research on understanding mechanisms of pain in dry eye, with an emphasis on studying new diagnostic and treatment modalities. Some of her research focused on how ocular surface symptoms, including pain, affect the quality of life. She has brought to light the role of nerve dysfunction in dry eye and has developed novel diagnostic and therapeutic metrics to address dry eye symptoms and ocular pain due to nerve sensitization. She first demonstrated that symptoms and signs of dry eye were often discordant. This observation prompted her to study whether nerve dysfunction was the missing link between the observed discordance. She demonstrated that many symptoms of dry eye, such as burning and sensitivity to wind and light, were shared with chronic pain conditions outside the eye. She has published her work in high-impact ophthalmology and pain journals. Dr. Galor was named to The Ophthalmologist Power List 2021.David R.P. Almeida, M.D., M.BA., Ph.D., FRCSC, DABO, is a highly accomplished vitreoretinal surgeon and researcher with extensive experience in ophthalmic and vitreoretinal studies. As Executive Chairman of Erie Retina Research and The Centers for Advanced Surgical Exploration (CASEx), Dr. Almeida leads innovative clinical research initiatives across multiple international sites. Dr. Almeida is a recognized thought leader in the field with over 300 peer-reviewed publications and more than 125 presentations at major conferences. His research interests span age-related macular degeneration, diabetic eye disease, complex surgery, and practice efficiency. As Principal Investigator, he has led over 100 clinical trials across all phases of development on three continents. Recognized for his expertise, Dr. Almeida has received numerous awards, including the American Society of Retina Specialists (ASRS) Honor Award, and has been named to The Ophthalmologist Power List Top 50 Rising Stars in Ophthalmology. Dr. Almeida’s academic background includes an Honors Bachelor of Science from the University of Toronto, a Ph.D. in pharmaceutical research from the University of Szeged, and an MBA in healthcare management from George Washington University. He completed medical school (Queen’s University, Canada), ophthalmology residency (Queen’s University, Canada), and a vitreoretinal diseases and surgery fellowship (University of Iowa, USA). - END - About OCS-01 eye drops and the OPTIREACH® technology Leveraging Oculis’ proprietary technology, OCS-01 is an OPTIREACH® formulation of high concentration dexamethasone eye drop. It is being developed as an eye drop to treat the retina to offer a non-invasive treatment alternative for diabetic macular edema (DME). This route of administration enables easy access to treatment in the early stages of the disease and can be used in combination with other therapies in later stages. In contrast, all currently available treatments require invasive delivery methods, such as intravitreal injections or ocular implants, to reach the retina. The OPTIREACH® solubilizing formulation technology addresses the main limitations of conventional eye drops by improving the solubility of lipophilic drugs, increasing the residence time on the eye surface and thereby, enabling the drug passage from the eye surface to the posterior segment of the eye. Oculis’ OCS-01 is being developed with the aim to transform the current treatment paradigm in DME as a non-invasive topical treatment option. OCS-01 is an investigational drug in Phase 3 that has not received regulatory approval for commercial use in any country. About Diabetic Macular Edema (DME) DME is the leading cause of visual loss and legal blindness in patients with diabetes. Currently, it is estimated to affect around 37 million people worldwide and, with the rise of diabetes, the prevalence is expected to increase to 53 million by 20401,2. DME is an irreversible and progressive complication of diabetic retinopathy and is related to consistently having high blood sugar levels that damage nerves and blood vessels in the macula, the area of the retina responsible for sharp vision. DME occurs when blood vessels in the retina swell, and then leak, leading to a fluid build-up (edema) into the retina. There remains a significant need for safe, efficacious, and less burdensome treatments for DME patients. About Licaminlimab (OCS-02)Licaminlimab is an anti-TNFα eye drop candidate being developed with a single chain antibody fragment (scFv) technology specifically designed to treat ocular inflammatory diseases. The dual anti-inflammatory and anti-necrotic mechanism of action of TNF-α inhibition has been well-established in inflammatory disorders where the systemic use of TNF-α inhibitors has led to marked improvements in the disease management and treatment outcomes. In Phase 2 trials, Licaminlimab has shown a positive treatment effect on both the signs and symptoms of DED and has been well tolerated. In addition, a genetic biomarker has been identified which showed an improved response to Licaminlimab in patients with a variant in the TNFR1 gene. Licaminlimab is an investigational drug in Phase 2 and has not received regulatory approval for commercial use in any country. About Dry Eye Disease (DED) DED is a common condition estimated to impact more than 110 million people in the G7 countries (U.S., U.K., Germany, France, Spain, Italy, Japan) and 40 million people in the U.S. alone3. It is a multifactorial disease in which ocular surface inflammation plays a central role in sustaining the pathological state4,5. It usually affects both eyes and patients may experience a stinging, burning or scratchy sensation. In addition, some patients experience sensitivity to light, eye redness, difficulty wearing contact lenses, difficulty with nighttime driving, and blurred vision which can greatly affect their quality of life. Of the approximately 20 million patients who are diagnosed with DED in the U.S., about half or 10 million are considered to have moderate to severe disease3. However, only 13% receive prescription treatment, primarily with an anti-inflammatory medications3. Despite currently available treatments, 87% of chronic patients still unsatisfied6 highlighting the tremendous unmet need remaining in this underserved patient population. Furthermore, given the heterogenicity of the DED patient population, there is a need for personalized treatment approaches to improve outcomes for patients. About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS / XICE: OCS) focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs. Oculis’ highly differentiated pipeline of multiple innovative product candidates in clinical development includes: OCS-01, a topical eye drop candidate for diabetic macular edema (DME); Privosegtor (OCS-05), a neuroprotective candidate for acute optic neuritis with potentially broad clinical applications in other neuro-ophthalmic diseases; and Licaminlimab (OCS-02), a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and is supported by leading international healthcare investors.For more information, please visit: www.oculis.com -ENDS- Oculis ContactsMs. Sylvia Cheung, CFOsylvia.cheung@oculis.com Investor Relations LifeSci AdvisorsCorey Davis, Ph.D.cdavis@lifesciadvisors.com Media RelationsICR HealthcareAmber Fennell / David Daley / Sean Leousoculis@icrhealthcare.com Cautionary Statement Regarding Forward Looking Statements This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of OCS-01 and Licaminlimab (OCS-02), including patient impact and market opportunity; the potential of OCS-01 to transform the treatment paradigm in DME as a non-invasive topical treatment option; the potential of Licaminlimab (OCS-02) to transform the treatment paradigm in DED; the initiation, timing, progress and results of Oculis’ clinical trials; Oculis’ research and development programs, regulatory and business strategy and future development plans; and Oculis’ ability to advance product candidates into, and successfully complete, clinical trials, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and other documents filed with the U.S. Securities and Exchange Commission (the “SEC”). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. Yau et al. Global Prevalence and Major Risk Factors of Diabetic Retinopathy, Diabetes Care 2012 Mar; 35(3): 556-564International Diabetes Federation – diabetesatlas.org Estimated diabetes prevalence worldwide in 2021: 537m, reaching 783m in 2045DRG (part of Clarivate) – Dry Eye Disease Landscape and Forecast report 2020TFOS DEWS II The Ocular Surface 15 (2017)Baudouin C. Dry Eye Disease, the complex interactions of vicious cycles. EuDES European Dry Eye Society https://www.dryeye-society.com/resources/dry-eye-disease-complex-interactions-vicious-cycles Mukamal, R. Why is Dry Eye So Difficult to Treat? 2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops