Ranibizumab (Genentech)

ISELIN, N.J., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has submitted a Type A meeting request to the U.S. Food and Drug Administration (FDA) following receipt of a Complete Response Letter (CRL) dated December 30, 2025, regarding the Company’s Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD). The CRL identified a single deficiency based on a purported lack of substantial evidence of effectiveness, and recommended submission of additional confirmatory evidence. Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the BLA, including data from an adequate and well-controlled study and confirmatory evidence of effectiveness. Based on prior discussions with the FDA in September 2025, during which Outlook Therapeutics understood that it had aligned with FDA on the requirements for resubmission of the BLA, the issuance of an additional CRL was unexpected. Prior to submitting the Type A meeting request, Outlook Therapeutics conducted informal meetings with the FDA to discuss the CRL. “Outlook Therapeutics remains confident in the strength of the clinical evidence supporting ONS-5010 and firmly believes the totality of data meets the FDA’s substantial evidence standard,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “We are committed to working constructively with the FDA to resolve these issues and to bringing this important therapy to patients with wet AMD in the United States.” The BLA for ONS-5010 is supported by clinically meaningful data, including results from NORSE TWO, a single adequate and well-controlled Phase 3 trial that demonstrated statistically significant and clinically relevant improvements in visual acuity at 12 months. NORSE TWO met its primary endpoint - patients gaining three lines (15 letters) of visual acuity - and a key secondary endpoint of mean change from baseline in visual acuity. Additional secondary endpoints, including gains of one line, two lines, and preservation of vision (loss of fewer than three lines), further reinforce the robustness and consistency of the treatment effect. At FDA’s request, Outlook Therapeutics also conducted NORSE EIGHT, a second adequate and well-controlled Phase 3 study. While NORSE EIGHT did not meet its primary endpoint at 8 weeks, the study demonstrated a positive trajectory consistent with NORSE TWO through 12 weeks of treatment and provided important functional and mechanistic/pharmacodynamic evidence of efficacy. Specifically, NORSE EIGHT showed consistent gains in best-corrected visual acuity across all measured timepoints, low variability, and results aligned with the established anti-VEGF mechanism of action. In addition to NORSE TWO and NORSE EIGHT, Outlook Therapeutics submitted a comprehensive package of confirmatory evidence, including mechanistic and pharmacodynamic data demonstrating VEGF inhibition and natural history data showing that the observed improvements with ONS-5010 represent a clear departure from the expected progression of untreated wet AMD. Outlook Therapeutics believes the resubmitted BLA fully satisfied the substantial evidence standard for demonstrating effectiveness, and intends to continue to work with the FDA on a path forward for resolving the FDA’s request for additional confirmatory evidence. ONS-5010 also demonstrated a favorable safety profile, with ocular adverse reactions consistent with both the control arm (ranibizumab) and with intravitreal injections generally and the FDA has never expressed any safety concerns with ONS-5010. The availability of an FDA-approved bevacizumab product for wet AMD would provide patients and physicians with a consistent, high-quality, commercially manufactured option supported by FDA-approved labeling, standardized manufacturing, and robust pharmacovigilance. ONS-5010/LYTENAVA™ (bevacizumab-vikg) is supported by a fully domestic, end-to-end U.S. manufacturing supply chain, enhancing reliability of supply and aligning with long-term public health and national resilience objectives. As previously announced, LYTENAVA™ (bevacizumab gamma) was granted Marketing Authorization by the European Commission in the EU and Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In June 2025, LYTENAVA™ (bevacizumab gamma) became commercially available in Germany and the UK for the treatment of wet AMD. In addition to current plans to expand its commercial presence in select countries in Europe, Outlook Therapeutics continues to speak with and explore collaborations with potential commercial and distribution partners in additional European countries, as well as outside of Europe. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the European Union and UK. About Outlook Therapeutics, Inc.Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) to enhance the standard of care for bevacizumab for the treatment of retina diseases. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD. In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “expect,” “may,” “on track,” “plan,” “potential,” “target,” “will,” or “would” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, expectations concerning Outlook Therapeutics’ plans to conduct a Type A meeting with the FDA and the ability to remediate or otherwise resolve the deficiency identified in the CRL, expectations concerning decisions of regulatory bodies and the timing thereof, the potential to receive approval from the FDA, the potential of ONS-5010/LYTENAVA™ as a treatment for wet AMD and to mitigate certain risks associated with the current off-label use of repackaged bevacizumab, and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, including the risk that Outlook Therapeutics is not able to provide sufficient evidence to support the approval by the FDA of the ONS-5010 BLA, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (the SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2025, filed with the SEC on December 19, 2025, and in future reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, tariffs and trade tensions, fluctuations in interest rates and inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law. Investor Inquiries:Jenene ThomasChief Executive OfficerJTC Team, LLCT: 908.824.0775OTLK@jtcir.com

Group sales grew by 7% 1 at constant exchange rates (CER; 2% in CHF), driven by strong demand for medicines and diagnostic solutions. Sales in the fourth quarter increased by 8%, reflecting the positive momentum. Pharmaceuticals Division sales increased by 9% (3% in CHF), with Phesgo (breast cancer), Xolair (food allergies), Ocrevus (multiple sclerosis), Hemlibra (haemophilia A) and Vabysmo (severe eye diseases) being the top growth drivers. Diagnostics Division sales grew 2% (-3% in CHF) as demand for pathology and molecular solutions continued to more than offset the impact of healthcare pricing reforms in China. Core operating profit increased by 13% (5% in CHF), driven by higher sales and efficiency gains. Core earnings per share showed growth of 11% (4% in CHF); IFRS net income increased by 58% (50% in CHF), due to the strong operational performance in 2025 and the base effect of impairment charges in 2024. Highlights: US and EU approval for the subcutaneous form of Lunsumio for a type of blood cancer EU approval for Gazyva/Gazyvaro for lupus nephritis, a serious kidney disease Positive data on several therapies: (phase III) giredestrant for breast cancer, fenebrutinib for two forms of multiple sclerosis, Gazyva/Gazyvaro for two immune-related diseases, PiaSky for a rare, life-threatening kidney condition and Enspryng for a rare autoimmune disease that affects the brain, spinal cord and optic nerves; (phase II) CT-388 for obesity Advancement of 10 key molecules into phase III development in 2025 EU CE mark for novel Elecsys Dengue Ag test to diagnose dengue and for cobas BV/CV assay to improve diagnostic accuracy for women affected by vaginitis CE Mark for test to monitor antibiotic therapies, expanding the only automated mass spectrometry platform on the market to an in vitro diagnostic menu of 39 tests Board proposes a dividend increase to CHF 9.80 per share and non-voting equity security. If approved by shareholders, this would be the 39th consecutive dividend increase. Change in Board of Directors Outlook for 2026 Roche (SIX: RO, ROG; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs. Key figures CHF millions % change January–December 2025 2024 At CER 1 In CHF Group sales 61,516 60,495 7 2 Pharmaceuticals Division 47,669 46,171 9 3 Diagnostics Division 13,847 14,324 2 -3 Core operating profit 21,833 20,823 13 5 Core EPS – diluted (CHF) 19.46 18.80 11 4 IFRS net income 13,799 9,187 58 50 Roche CEO Thomas Schinecker : “2025 was a strong year for Roche, reflecting our continued focus on operational and R&D excellence. We have significant momentum across our pharmaceutical pipeline: ten potential new medicines advanced into final-stage development, and 12 late-stage clinical studies delivered positive results. We had important breakthroughs in lupus and oestrogen receptor-positive breast cancer, which accounts for approximately 70% of all breast cancer cases, as well as the first positive late-stage clinical results in a new therapy for multiple sclerosis. We are also setting new standards in diagnostics: our next-generation sequencing technology, which will be launched this year, decoded an entire human genome in less than four hours. With our strong financial performance and our continued progress in innovation, we are well positioned for growth.” Change in Board of Directors The Board of Directors will propose Lubomira Rochet (1977), Executive Vice President and member of the Group Executive Committee of Societe Generale, for election as a new Board member at the upcoming Annual General Meeting. Severin Schwan , Chairman of the Board: “Lubomira Rochet brings a broad leadership track record and deep experience in business transformations through digital and technology. I am very pleased that we can propose her for election to the Board of Directors.” As previously announced, Dr Claudia Suessmuth Dyckerhoff has decided not to stand for re-election as a member of the Roche Board of Directors at the Annual General Meeting in 2026. Group results In 2025, Roche achieved sales growth of 7% (2% in CHF) to CHF 61.5 billion due to strong demand for pharmaceutical products and diagnostic solutions. The appreciation of the Swiss franc against most currencies, notably the US dollar, had a significant impact on the results reported in Swiss francs compared to constant exchange rates. Core operating profit increased by 13% (5% in CHF) to CHF 21.8 billion, driven by higher sales and efficiency gains. Core earnings per share increased by 11% (4% in CHF). IFRS net income increased by 58% (50% in CHF) to CHF 13.8 billion due to the strong operating performance in 2025 and the base effect of impairment charges in 2024. Sales in the Pharmaceuticals Division increased by 9% (3% in CHF) to CHF 47.7 billion, with medicines for severe diseases continuing their strong growth. The top five growth drivers – Phesgo, Xolair, Ocrevus, Hemlibra and Vabysmo – achieved total sales of CHF 21.4 billion, an increase of CHF 3.2 billion (CER) compared to 2024. Sales of products with expired patents – Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Esbriet (lung disease), Lucentis (severe eye diseases) and Actemra/RoActemra (rheumatoid arthritis) – decreased by a combined CHF 0.7 billion (CER). In the United States , sales rose by 8% due to continued growth of Xolair and continuing uptake of Ocrevus, Phesgo, Hemlibra and Polivy (blood cancer). This growth more than compensated for the decline in sales of medicines with expired patents. Sales in Europe grew 5% as strong demand for Ocrevus and Vabysmo and the continuing uptake of Polivy, Hemlibra and Phesgo more than compensated for the lower sales of Perjeta (breast cancer) due to the ongoing conversion of patients to Phesgo, and the impact of biosimilar competition on Actemra/RoActemra sales. In Japan , sales increased by 5%, mainly due to the strong uptake of Phesgo, Vabysmo, Hemlibra, Enspryng (acute inflammation of optic nerve and spinal cord) and PiaSky (paroxysmal nocturnal haemoglobinuria). Sales growth was partially offset by the decline in sales of Avastin because of biosimilar erosion and Perjeta due to the continued conversion of patients to Phesgo. Sales in the International region rose by 14%, led by Phesgo, Xofluza (influenza), Hemlibra, Vabysmo, Elevidys (Duchenne muscular dystrophy) and Polivy. In China, sales rose by 10%, driven by the uptake of Phesgo due to the inclusion in the government drug reimbursement list, strong sales of Xofluza and the continued roll-out of Vabysmo and Polivy. The Diagnostics Division’s sales increased by 2% (-3% in CHF) to CHF 13.8 billion as growth in demand for pathology and molecular solutions more than offset the impact of healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region increased by 6%, driven by higher sales of clinical chemistry and immunodiagnostic products. In North America , sales increased by 9%, with growth across all customer areas. Sales in Asia-Pacific decreased by 12% due to healthcare pricing reforms in China. In Latin America , sales grew by 11%. Pharmaceuticals Division: pipeline With 66 new molecular entities (NMEs) and a total of 107 projects, Roche has a promising pipeline with a wide variety of therapeutic approaches. Pharmaceuticals research and development (R&D) expenditure decreased by 3% to CHF 10.4 billion (Group R&D: -3% to CHF 12.2 billion). Oncology remained the primary area for R&D, with substantial investments also in the areas of cardiovascular, renal and metabolism and immunology. Pharmaceuticals: key developments Compound Milestone Regulatory Lunsumio Blood cancer FDA approves Lunsumio VELO for subcutaneous use in relapsed or refractory follicular lymphoma Lunsumio VELO reduces administration time from 2‒4 hours to approximately 1 minute. Availability of Lunsumio VELO allows treatment aligned to people’s clinical needs and personal preferences. The approval is supported by data demonstrating compelling complete response rate in third-line or later treatment of people with follicular lymphoma, a disease that typically becomes harder to treat after each relapse. More information: Media Release , 22 December 2025 Gazyva/Gazyvaro Lupus nephritis European Commission approves Gazyva/Gazyvaro for adults with active lupus nephritis Approval based on phase II NOBILITY and phase III REGENCY studies showing superiority of Gazyva/Gazyvaro over standard therapy alone. Gazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a benefit in a complete renal response in lupus nephritis in a randomised phase III study. Gazyva/Gazyvaro could become a new standard of care for up to an estimated 135,000 people affected by lupus nephritis in the European Union, potentially helping to delay or prevent end-stage kidney disease. More information: Media Release , 9 December 2025 Lunsumio Blood cancer European Commission approves Lunsumio subcutaneous for relapsed or refractory follicular lymphoma Lunsumio provides high rates of deep and long-lasting responses in third-line and later treatment of people with follicular lymphoma, a disease that typically becomes harder to treat each time a patient relapses. Lunsumio subcutaneous offers a new treatment option that can significantly reduce administration time to approximately 1 minute. Lunsumio SC allows patients to receive treatment aligned to clinical requirements and lifestyle preferences. More information: Media Release , 19 November 2025 Phase III, pivotal and other key read-outs CT-388 Obesity Roche announces positive phase II results for its dual GLP-1/GIP receptor agonist CT-388 in people living with obesity A once-weekly subcutaneous injection of CT-388 achieved a statistically significant placebo-adjusted weight loss of 22.5% (p < 0.001) at 48 weeks at the highest dose tested (24 mg), without reaching a weight loss plateau. 54% of participants on the 24 mg dose achieved resolution of obesity (BMI <30 kg/m 2 ) vs 13% in the placebo group. CT-388 demonstrated a safety and tolerability pro consistent with that of its drug class with no new or unexpected safety signals. More information: Media Release , 27 January 2026 Giredestrant Breast cancer Giredestrant reduces risk of invasive disease recurrence or death by 30% in ER-positive early-stage breast cancer Giredestrant is the only oral SERD to show superior invasive disease-free survival in the adjuvant setting, marking the first significant endocrine therapy advance in over 20 years1‒3. Transformational results support the potential of giredestrant to become a new standard-of-care for early-stage disease. ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and up to a third of patients experience recurrence on or after adjuvant endocrine therapy treatment. More information: Media Release , 10 December 2025 Lunsumio Blood cancer Roche presents Lunsumio data showing potential across earlier treatment lines in indolent and aggressive lymphomas Lunsumio in combination with lenalidomide may offer an effective treatment in relapsed or refractory follicular lymphoma based on first data from single-arm US cohort of phase III CELESTIMO study. Data from subcutaneous Lunsumio plus Polivy reinforce its outpatient, chemotherapy-free potential in people with relapsed or refractory large B-cell lymphoma. Results highlight the potential of innovative Lunsumio combination regimens to offer improved outcomes for more people with lymphoma earlier in their disease. More information: Media Release , 8 December 2025 Columvi Blood cancer Columvi combination shows sustained survival benefit at three-year follow-up of pivotal phase III STARGLO study Overall survival was twice as long for people treated with Columvi in combination with GemOx versus MabThera/Rituxan plus GemOx. This Columvi combination is available off-the-shelf and could offer a potentially curative treatment option for people with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who are not candidates for transplant. Columvi in combination with GemOx has now been approved in more than 50 countries worldwide and is recommended in international treatment guidelines. More information: Media Release , 8 December 2025 Giredestrant Breast cancer Giredestrant becomes the first oral SERD to show superior invasive disease-free survival in early breast cancer At interim analysis, giredestrant demonstrated a statistically significant and clinically meaningful benefit versus standard-of-care endocrine monotherapy. These unprecedented results support its potential as a new standard-of-care endocrine therapy in the early-stage setting. lidERA is the second positive phase III read-out for giredestrant following evERA presented at ESMO 2025. More information: Media Release , 18 November 2025 Fenebrutinib Multiple sclerosis Fenebrutinib shows unprecedented positive phase III results as the potential first and only BTK inhibitor in both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) The first pivotal RMS study (FENhance 2) met its primary endpoint, with fenebrutinib significantly reducing relapses compared to teriflunomide. In the pivotal PPMS study (FENtrepid), fenebrutinib slowed disability progression at least as effectively as Ocrevus, the only approved therapy in PPMS. Full data from both studies will be shared at upcoming medical meetings; all data will be considered for regulatory submission after the second RMS study (FENhance 1) reads out, expected in the first half of 2026. More information: Media Release , 10 November 2025 Haematology Roche presents new data from its broad and innovative haematology portfolio at ASH 2025 Findings demonstrate the effectiveness of Roche’s approved medicines in advancing treatment standards for people with blood disorders. Data from innovative pipeline signals progress towards improved outcomes in haemophilia A, lymphoma and multiple myeloma. More information: Media Release , 3 November 2025 Gazyva/Gazyvaro Systemic lupus erythematosus Positive phase III data for Gazyva/Gazyvaro show significant reduction in disease activity for systemic lupus erythematosus (SLE) Phase III ALLEGORY study met primary and all key secondary endpoints with Gazyva/Gazyvaro, demonstrating significant reduction in disease activity for SLE. Gazyva/Gazyvaro has the potential to become a transformative new standard of care for up to 3.4 million people affected by SLE worldwide, and would be the first anti-CD20 therapy for SLE to directly target B cells if approved. These positive results follow recent US FDA approval and positive EU CHMP opinion for Gazyva/Gazyvaro in lupus nephritis, as well as positive phase III data from the INShore study in idiopathic nephrotic syndrome. More information: Media Release , 3 November 2025 Gazyva/Gazyvaro Idiopathic nephrotic syndrome Positive phase III results for Gazyva/Gazyvaro in children and young adults with idiopathic nephrotic syndrome Gazyva/Gazyvaro versus mycophenolate mofetil shows significantly more children and young adults achieved sustained complete remission at week 52. If approved, Gazyva/Gazyvaro could help children and young adults sustain remission, potentially with a reduced need for steroids to manage their disease. INShore is the first global phase III study of a targeted therapy in this chronic kidney disease commonly diagnosed in early childhood. More information: Media Release , 28 October 2025 Other 89bio tender offer Roche completes tender offer for 89bio, Inc. shares and prepares to finalise acquisition Roche’s subsidiary Bluefin Merger Subsidiary, Inc. accepted for payment all shares validly tendered and not withdrawn in its tender offer for 89bio at USD 14.50 per share in cash plus a contingent value right for up to USD 6.00 per share. Approximately 94,113,710 shares, representing about 60.49% of 89bio’s outstanding common stock, were validly tendered and not withdrawn in the offer, and the tender offer expired on 29 October 2025. Roche intends to complete the acquisition of 89bio through a merger, after which 89bio will become a wholly owned subsidiary of Roche and its shares will be delisted from Nasdaq. More information: Media Release , 30 October 2025 Pharmaceuticals sales Sales CHF millions As % of sales % change January–December 2025 2024 2025 2024 At CER In CHF Pharmaceuticals Division 47,669 46,171 100.0 100.0 9 3 United States 25,355 24,774 53.2 53.7 8 2 Europe 9,164 8,832 19.2 19.1 5 4 Japan 2,882 2,874 6.0 6.2 5 0 International 10,268 9,691 21.6 21.0 14 6 International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top 20 best-selling pharmaceuticals Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % Ocrevus Multiple sclerosis 7,010 9 4,874 7 1,451 13 - - 685 21 Hemlibra Haemophilia A 4,754 11 2,665 6 1,002 10 377 8 710 38 Vabysmo Eye diseases (nAMD, DME, RVO) 4,102 12 2,857 3 741 21 146 22 358 116 Tecentriq Cancer immunotherapy 3,566 3 1,640 -2 878 3 349 -4 699 18 Xolair 2 Asthma, food allergies 3,075 32 3,075 32 - - - - - - Perjeta 2 Breast cancer 2,968 -13 1,268 0 552 -13 69 -37 1,079 -21 Actemra/RoActemra 2 RA, COVID-19 2,470 -2 1,206 -4 588 -9 310 5 366 16 Phesgo Breast cancer 2,441 48 708 31 812 12 188 44 733 172 Kadcyla 2 Breast cancer 2,025 7 768 6 532 -4 91 -3 634 22 Evrysdi Spinal muscular atrophy 1,757 13 612 10 616 9 90 1 439 25 Alecensa Lung cancer 1,562 6 565 14 262 -6 204 7 531 5 Polivy Blood cancer 1,470 38 688 28 290 53 207 9 285 87 MabThera/Rituxan 2 Blood cancer, RA 1,251 -4 794 0 140 -5 14 -11 303 -12 Activase/TNKase 2 Cardiac diseases 1,107 -2 1,056 -2 - - - - 51 -11 Herceptin 2 Breast and gastric cancer 1,028 -22 225 -10 291 -2 7 -43 505 -32 Gazyva/Gazyvaro 2 Blood cancer 986 14 519 19 245 2 35 25 187 15 Avastin 2 Various cancer types 973 -17 299 -17 70 -16 145 -23 459 -14 Pulmozyme 2 Cystic fibrosis 479 12 343 20 65 -9 1 -12 70 1 Xofluza Influenza 407 184 57 66 2 * - - 348 219 CellCept 2 Immunosuppressant 385 1 21 -5 131 8 44 17 189 -6 * Over 500% DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics Division: portfolio In Diagnostics, Roche introduced two instrument platforms, six digital solutions and 53 new tests in 2025. The main areas of R&D activity included the development of high medical value assays, notably for the oncology disease area, as well as of digital solutions and sequencing. In addition, there were continuing investments in cardiometabolic diseases, particularly for continuous blood glucose monitoring. Diagnostics: key developments Product Milestone cobas Mass Spec solution Roche expands automated mass spectrometry menu with antibiotics drug monitoring CE mark approval offering industry’s broadest in vitro diagnostic menu With this approval, Roche’s automated mass spectrometry platform now offers the industry’s broadest in vitro diagnostic menu with 39 tests, including tests for therapeutic drug monitoring for immunosuppressants and antibiotics, as well as steroid hormones and vitamin D metabolites. The comprehensive menu brings the sensitivity and specificity of gold-standard testing into routine labs for a wide range of the most frequently tested targets. The fully automated solution replaces labour-intensive manual workflows, reducing turnaround times and supporting faster, standardised, high-quality care. More information: Media Release , 11 December 2025 cobas BV/CV test Vaginitis Roche launches new PCR test to help improve diagnostic accuracy for women affected by vaginitis in countries following the CE mark The new PCR test aids in the diagnosis of infectious causes of vaginitis through the detection of bacteria associated with bacterial vaginosis and yeast associated with candida vaginitis. The test will help improve diagnostic accuracy for millions of women affected by vaginitis annually, delivering more accurate and specific results. This test offers faster diagnosis by using a single vaginal swab for broader sexual health testing, eliminating the need for an additional sample. More information: Media Release , 9 December 2025 cobas liat Bordetella panel Infectious diseases Roche receives FDA clearance with CLIA waiver and CE mark for its first point-of-care test for diagnosing Bordetella infections, including whooping cough (pertussis) The point-of-care test delivers PCR-accurate results in just 15 minutes, enabling healthcare providers to act quickly and prevent severe complications and onward transmission. The test detects and differentiates between three types of Bordetella infection that can cause similar cough symptoms, ensuring patients receive the right diagnosis at the earliest opportunity. Early diagnosis can reduce the risk of complications and severe disease in vulnerable groups such as infants and the elderly, by enabling faster, more precise care decisions. More information: Media Release , 2 December 2025 Elecsys Dengue Ag test Dengue Roche receives CE mark for novel automated high-throughput Elecsys Dengue Ag test to diagnose dengue New dengue antigen test delivers high clinical sensitivity and specificity, as well as inclusivity for all four dengue virus serotypes, helping clinicians confidently distinguish dengue from other acute fever-causing illnesses. Full automation facilitates medium to high throughput and enables improvement of lab efficiency and test traceability, while reducing the risk of human error. Test delivers results in just 18 minutes, enabling faster laboratory workflows and patient management during outbreaks. More information: Media Release , 29 October 2025 Diagnostics sales Sales CHF millions As % of sales % change January–December 2025 2024 2025 2024 At CER In CHF Diagnostics Division 13,847 14,324 100.0 100.0 2 -3 Customer areas 3 Core Lab 7,614 8,011 55.0 55.9 0 -5 Molecular Lab 2,527 2,554 18.3 17.8 4 -1 Near Patient Care 1,983 2,160 14.3 15.1 -3 -8 Pathology Lab 1,723 1,599 12.4 11.2 14 8 Regions Europe, Middle East, Africa 4,965 4,822 35.9 33.7 6 3 North America 4,444 4,335 32.1 30.3 9 3 Asia-Pacific 3,386 4,099 24.4 28.6 -12 -17 Latin America 1,052 1,068 7.6 7.4 11 -1 More information on Roche’s performance in 2025: Finance Report 2025 Annual Report 2025 Full-year 2025 presentation Appendix with tables About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References [1] Unless otherwise stated, all growth rates and year-on-year comparisons are at constant exchange rates (CER; average rates 2024) and all total figures quoted are reported in Swiss francs. [2] Products launched before 2015. [3] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech. Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics, genomic tumour profiling. Near Patient Care: diagnostics solutions in emergency rooms, medical practices and directly with patients, including integrated personalised diabetes management. Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics. In 2025, sales in the Pathology Lab customer area include sales previously reported in the Molecular Lab customer area to foster business transparency and harmonisation in the use of solutions in the area of cervical intraepithelial neoplasia technology (CINtec). The comparative information for 2024 has been restated accordingly. In 2025, sales in the Core Lab customer area include sales previously reported in the Near Patient Care customer area to centralise digital healthcare solutions within Roche Information Solutions. The comparative information for 2024 has been restated accordingly. Cautionary statement regarding forward-looking statements This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Global Media Relations Phone: +41 61 688 88 88 / E-mail: media.relations@roche.com Hans Trees, PhD Phone: +41 79 407 72 58 Sileia Urech Phone: +41 79 935 81 48 Nathalie Altermatt Phone: +41 79 771 05 25 Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 327 29 15 Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +49 172 636 72 62 Yvette Petillon Phone: +41 79 961 92 50 Dr Rebekka Schnell Phone: +41 79 205 27 03 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 687 52 84 E-mail: bruno.eschli@roche.com Dr Sabine Borngräber Phone: +41 61 688 80 27 E-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 688 48 14 E-mail: birgit.masjost@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 32 17 E-mail: kalm.loren@gene.com Attachments Media Investor Release Roche FY 2025 English Communications appendix tables FY 2025 Results