A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

Start Date16 Dec 2024

Sponsor / Collaborator

Janssen Research & Development LLC

KCT0009698

/ RecruitingNot ApplicableIIT

The first line Lazertinib treatment for metastatic EGFRm NSCLC; the real world evidence in South Korea

Start Date29 Aug 2024

Sponsor / Collaborator

Hallym University Medical Center

KCT0008774

/ RecruitingPhase 2IIT

A randomized, phase 2 trial of lazertinib and chemotherapy combination in EGFR-mutant NSCLC patients without ctDNA clearance after lead-in lazertinib monotherapy (CHAMELEON)

Start Date01 Aug 2024

Sponsor / Collaborator

Yonsei University Severance Hospital

100 Clinical Results associated with Lazertinib Mesylate

100 Translational Medicine associated with Lazertinib Mesylate

100 Patents (Medical) associated with Lazertinib Mesylate

139

Literatures (Medical) associated with Lazertinib Mesylate

01 Dec 2025·Current Neurology and Neuroscience Reports

Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review

Review

Author: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek

PURPOSE OF REVIEW:

Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.

RECENT FINDINGS:

In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.

01 Nov 2025·Nature Reviews Clinical Oncology

MARIPOSA demonstrates overall survival benefit from amivantamab–lazertinib

Article

Author: Romero, Diana

30 Oct 2025·NEW ENGLAND JOURNAL OF MEDICINE

Overall Survival with Amivantamab–Lazertinib in EGFR -Mutated Advanced NSCLC

Article

Author: Gadgeel, Shirish M. ; Mukhedkar, Sanjay ; Yang, James Chih-Hsin ; Thomas, Michael ; Cheng, Ying ; Hayashi, Hidetoshi ; Yazici, Ozan ; Xie, John ; Kim, Sang-We ; Besse, Benjamin ; Passaro, Antonio ; Gutiérrez Calderón, Vanesa ; Alves, Sara ; Yoshioka, Hiroshige ; Şendur, Mehmet Ali Nahit ; Liu, Baogang ; Sun, Tao ; Califano, Raffaele ; Knoblauch, Roland E. ; Mehta, Jaydeep ; de Marinis, Filippo ; Spira, Alexander I. ; Mourão Dias, Josiane ; Korbenfeld, Ernesto ; Vázquez Limón, Juan Carlos ; Stroyakovskiy, Daniil ; Lu, Shun ; Ennis, Mariah ; Man, Julie ; Ou, Sai-Hong Ignatius ; Chang, Gee-Chen ; Prabhash, Kumar ; Baig, Mahadi ; Lee, Se-Hoon ; Venkatasubramanian, Raja ; Lee, Ki-Hyeong ; Felip, Enriqueta ; Sethi, Seema ; D’Arcangelo, Manolo ; Kim, Yu Jung ; Danchaivijitr, Pongwut ; How, Soon-Hin ; Bauml, Joshua M. ; Xiong, Hailin ; Alatorre-Alexander, Jorge ; Fennema, Elizabeth ; Owen, Scott ; Cho, Byoung Chul ; Daksh, Mahesh ; Roshak, Amy ; Shah, Sujay ; Nguyen, Danny ; Girard, Nicolas ; Ostapenko, Yurii ; Alip, Adlinda ; Peregudova, Marina

BACKGROUND:

Previous results from this phase 3 trial showed that progression-free survival among participants with previously untreated EGFR (epidermal growth factor receptor)-mutated advanced non-small-cell lung cancer (NSCLC) was significantly improved with amivantamab-lazertinib as compared with osimertinib. Results of the protocol-specified final overall survival analysis in this trial have not been reported.

METHODS:

We randomly assigned, in a 2:2:1 ratio, participants with previously untreated EGFR-mutated (exon 19 deletion or L858R substitution), locally advanced or metastatic NSCLC to receive amivantamab-lazertinib, osimertinib, or lazertinib. Overall survival (assessed in an analysis of the time from randomization to death from any cause) in the amivantamab-lazertinib group as compared with the osimertinib group was a key secondary end point. Additional end points included safety.

RESULTS:

A total of 429 participants each were assigned to receive amivantamab-lazertinib or osimertinib. Over a median follow-up of 37.8 months, amivantamab-lazertinib led to significantly longer overall survival than osimertinib (hazard ratio for death, 0.75; 95% confidence interval, 0.61 to 0.92; P = 0.005); 3-year overall survival was 60% and 51%, respectively. At the clinical cutoff date, 38% of participants in the amivantamab-lazertinib group and 28% in the osimertinib group were still receiving the assigned treatment. Adverse events of grade 3 or higher were more common with amivantamab-lazertinib (in 80% of participants) than with osimertinib (in 52%), particularly skin-related events, venous thromboembolism, and infusion-related events; these findings were consistent with the established safety profile of each treatment. No new safety signals were observed with additional follow-up.

CONCLUSIONS:

Amivantamab-lazertinib led to significantly longer overall survival among participants with previously untreated EGFR-mutated advanced NSCLC than osimertinib but was associated with an increased risk of adverse events of grade 3 or higher. (Funded by Janssen Research and Development; MARIPOSA ClinicalTrials.gov number, NCT04487080.).

180

News (Medical) associated with Lazertinib Mesylate

19 Oct 2025

·www.prnewswire.com

Subcutaneous amivantamab delivers promising 45 percent overall response rate with median duration of 7.2 months in recurrent or metastatic head and neck cancer

Responses were rapid and durable, and tumor shrinkage was observed in 82 percent of patients New findings from this investigational study build on the strength of RYBREVANT® (amivantamab-vmjw) in non-small cell lung cancer and broadens its potential across additional solid tumors RARITAN, N.J., Oct. 19, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced promising new results from the Phase 1b/2 OrigAMI-4 study evaluating the efficacy and safety of subcutaneous (SC) amivantamab monotherapy in patients with human papillomavirus (HPV)-unrelated, recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) after disease progression on a checkpoint inhibitor and platinum-based chemotherapy. The study used the new subcutaneous formulation of amivantamab, which can be delivered in a five-minute manual injection, offering increased patient convenience compared to intravenous RYBREVANT® (amivantamab-vmjw). Data were presented during a mini-oral session at the European Society for Medical Oncology (ESMO) 2025 Congress (Oral Abstract #1327MO).1 Patients with R/M HNSCC have limited options and poor outcomes after disease progression on a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy.2 Many are unable to receive further treatment, and for those who do, response rates with available therapies are typically only 10 to 24 percent.2,3,4 Survival remains short, with a median of 6 to 9 months, and may be even shorter among patients with HPV-unrelated disease.2,4,5,6 Patients also face a significant burden of symptoms such as difficulty swallowing, impaired speech, pain and fatigue.2 Epidermal growth factor receptor (EGFR) and MET, two key tumor drivers, are overexpressed in 80 to 90 percent of HNSCC tumors, highlighting their role as potential treatment targets.7,8,9 RYBREVANT®, the world's first bispecific antibody approved for lung cancer, inhibits EGFR and MET, in addition to activating the immune system to attack cancer cells.10 "Patients with recurrent or metastatic head and neck cancer face an aggressive disease that significantly impacts their quality of life," said Professor Kevin Harrington*, MBBS, Ph.D., Professor in Biological Cancer Therapies at The Institute of Cancer Research, Royal Marsden Hospital, London, UK, and primary study investigator. "These results represent one of the most encouraging response rates we've seen in this difficult-to-treat setting, with durability that could meaningfully extend the time patients live without their disease progressing." In Cohort 1 of the OrigAMI-4 study, treatment with SC amivantamab resulted in an overall response rate (the primary endpoint) of 45 percent in 38 efficacy-evaluable patients with R/M HNSCC unrelated to HPV with disease progression on or after a PD-1 or PD-L1 checkpoint inhibitor and platinum-based chemotherapy (95 percent confidence interval [CI], 29-62).1 Responses occurred quickly, with a median time to first response of 6.4 weeks (range, 5.7-18.3), and were durable, with a median duration of response of 7.2 months (95 percent CI, 5.3-not estimable [NE]).1,11 Tumor shrinkage of target lesions was observed in 82 percent of patients after 8.3 months follow-up.1 Median progression-free survival was 6.8 months (95 percent CI, 4.2-9.0), while median overall survival had not yet been reached (95 percent CI, 7.7-NE).1 "These data highlight the broader potential of RYBREVANT-based therapies across solid tumors where the EGFR and/or MET pathways are activated," said Kiran Patel, Vice President, Global Head, Solid Tumor Clinical Development and Diagnostics, Johnson & Johnson Innovative Medicine. "RYBREVANT combinations have already demonstrated significant results for certain patients with non-small cell lung cancer, leading to extended survival and delayed treatment resistance. Now we're building on that progress in other hard-to-treat diseases like head and neck cancer. By targeting EGFR and MET while also engaging the immune system, subcutaneous amivantamab could provide new options for more patients who have few effective treatments." The safety-evaluable population included 86 patients who received at least one dose of SC amivantamab monotherapy. The safety profile was consistent with prior SC amivantamab monotherapy studies, with no new safety signals observed. The most common treatment-emergent adverse events were fatigue (31 percent), hypoalbuminemia (31 percent) and stomatitis (23 percent). Administration-related reactions occurred in seven percent of patients, all mild to moderate (grade 1-2), with no severe events. Treatment discontinuation due to treatment-related adverse events occurred in two percent of patients.1 Based on these results, Johnson & Johnson is initiating further study of SC amivantamab in head and neck cancer with the Phase 3 OrigAMI-5 study, which is evaluating first-line SC amivantamab with pembrolizumab and carboplatin versus 5-fluorouracil (5FU) plus pembrolizumab and platinum-based chemotherapy (cisplatin or carboplatin) in patients with HPV-unrelated R/M HNSCC. In addition to supporting further evaluation in first-line R/M HNSCC, these findings add to the evidence supporting the role of RYBREVANT®-based treatments across multiple solid tumors, including non-small cell lung cancer, colorectal cancer and HNSCC. About the OrigAMI-4 Study OrigAMI-4 (NCT06385080) is an open-label Phase 1b/2 study evaluating SC amivantamab in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The study includes five cohorts, including Cohort 1, which studied SC amivantamab as monotherapy in patients with human papillomavirus (HPV)-unrelated R/M HNSCC who had received prior platinum-based chemotherapy and PD-1/PD-L1 immunotherapy. Patients with prior anti-EGFR therapy were excluded. Subcutaneous amivantamab was administered every three weeks (Q3W) at 2400 mg, or 3360 mg for patients weighing 80 kg or more. The primary endpoint is overall response rate (ORR), assessed by blinded independent central review (BICR) using RECIST v1.1**.12 About Head and Neck Squamous Cell Carcinoma Head and neck squamous cell carcinoma (HNSCC) is the most common type of head and neck cancer, accounting for more than 90 percent of cases and approximately 4.5 percent of all cancers worldwide.13 It develops in the mucosal linings of the oral cavity, oropharynx, hypopharynx, and larynx.13 Major risk factors include tobacco and alcohol use, as well as infection with high-risk human papillomavirus (HPV).13 Around 75 percent of cases are HPV-negative, which is typically associated with a poorer prognosis and reduced response to treatment.13,14 Despite advances in surgery, radiation, chemotherapy, and immunotherapy, many patients are diagnosed at an advanced stage, and recurrent or metastatic HNSCC continues to carry a poor prognosis.2,7 About Subcutaneous Amivantamab Subcutaneous amivantamab is an investigational fixed-dose combination of the bispecific antibody amivantamab and recombinant human hyaluronidase PH20 (rHuPH20), which is part of Halozyme's ENHANZE® drug delivery technology. It targets EGFR and MET with immune cell-directing activity and is being developed to address tumors driven by activating and resistance EGFR mutations as well as MET alterations. Subcutaneous amivantamab is being studied across multiple tumor types, including head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC). About RYBREVANT® RYBREVANT® (amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity, is approved in the U.S., Europe and other markets around the world as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.10 RYBREVANT® is approved in the U.S., Europe and other markets around the world in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test. RYBREVANT® is approved in the U.S., Europe and other markets around the world in combination with LAZCLUZE® (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. RYBREVANT® is approved in the U.S., Europe and other markets around the world in combination with chemotherapy (carboplatin-pemetrexed) for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR TKI. Subcutaneous amivantamab is approved in Europe in combination with LAZCLUZE® for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. A Biologics License Application (BLA) was submitted to the U.S. FDA for this indication. The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC§ prefer next-generation sequencing–based strategies over polymerase chain reaction–based approaches for the detection of EGFR exon 20 insertion, exon 19 deletion and L858R variants. The NCCN Guidelines include: Amivantamab-vmjw (RYBREVANT®) plus lazertinib (LAZCLUZE®) as a Category 1 recommendation for first-line therapy in patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations.15†‡ Amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a Category 1 recommendation for patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations who experienced disease progression after treatment with osimertinib.15 †‡ Amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a Category 1 recommendation for first-line therapy in treatment-naive patients with newly diagnosed advanced or metastatic EGFR exon 20 insertion mutation-positive advanced NSCLC. 15 †‡ Amivantamab-vmjw (RYBREVANT®) as a Category 2A recommendation for patients that have progressed on or after platinum-based chemotherapy with or without an immunotherapy and have EGFR exon 20 insertion mutation-positive NSCLC. 15 †‡ In addition to the Phase 1b/2 OrigAMI-4 study, RYBREVANT® is being studied in multiple clinical trials, including: The Phase 3 MARIPOSA (NCT04487080) study assessing RYBREVANT® in combination with LAZCLUZE® versus osimertinib and versus LAZCLUZE® alone in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or substitution mutations.16 The Phase 3 MARIPOSA-2 (NCT04988295) study assessing the efficacy of RYBREVANT® (with or without LAZCLUZE®) and carboplatin-pemetrexed versus carboplatin-pemetrexed alone in patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations after disease progression on or after osimertinib.17 The Phase 3 PAPILLON (NCT04538664) study assessing RYBREVANT® in combination with carboplatin-pemetrexed versus chemotherapy alone in the first-line treatment of patients with advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.18 The Phase 3 PALOMA-3 (NCT05388669) study assessing LAZCLUZE® with subcutaneous (SC) amivantamab compared to RYBREVANT® in patients with EGFR-mutated advanced or metastatic NSCLC.19 The Phase 2 PALOMA-2 (NCT05498428) study assessing SC amivantamab in patients with advanced or metastatic solid tumors including EGFR-mutated NSCLC.20 The Phase 1 PALOMA (NCT04606381) study assessing the feasibility of SC amivantamab based on safety and pharmacokinetics and to determine a dose, dose regimen and formulation for SC amivantamab delivery.21 The Phase 1 CHRYSALIS (NCT02609776) study evaluating RYBREVANT® in patients with advanced NSCLC.22 The Phase 1/1b CHRYSALIS-2 (NCT04077463) study evaluating RYBREVANT® in combination with LAZCLUZE® and LAZCLUZE® as a monotherapy in patients with advanced NSCLC with EGFR mutations.23 The Phase 1/2 METalmark (NCT05488314) study assessing RYBREVANT® and capmatinib combination therapy in locally advanced or metastatic NSCLC.24 The Phase 1/2 swalloWTail (NCT06532032) study assessing RYBREVANT® and docetaxel combination therapy in patients with metastatic NSCLC.25 The Phase 1/2 PolyDamas (NCT05908734) study assessing RYBREVANT® and cetrelimab combination therapy in locally advanced or metastatic NSCLC.26 The Phase 2 SKIPPirr study (NCT05663866) exploring how to decrease the incidence and/or severity of first-dose infusion-related reactions with RYBREVANT® in combination with LAZCLUZE® in relapsed or refractory EGFR-mutated advanced or metastatic NSCLC.27 The Phase 2 COPERNICUS (NCT06667076) study combining developments in treatment administration and prophylactic supportive care in representative US patients with common EGFR-mutated NSCLC treated with SC amivantamab in combination with LAZCLUZE® or chemotherapy.28 The Phase 2 COCOON (NCT06120140) study assessing the effectiveness of a proactive dermatologic management regimen given with first-line RYBREVANT® and LAZCLUZE® in patients with EGFR-mutated advanced NSCLC.29 The Phase 1b/2 OrigAMI-1 (NCT05379595) study assessing RYBREVANT® monotherapy and in addition to standard-of-care chemotherapy in patients with advanced or metastatic colorectal cancer.30 The legal manufacturer for RYBREVANT® is Janssen Biotech, Inc. For more information, visit: . RYBREVANT ® IMPORTANT SAFETY INFORMATION 10 WARNINGS AND PRECAUTIONS Infusion-Related Reactions RYBREVANT® can cause infusion-related reactions (IRRs) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour. RYBREVANT ® with LAZCLUZE ® In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT® in 4.5% of patients. RYBREVANT ® with Carboplatin and Pemetrexed Based on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. The incidence of infusion modifications was 46%, and 2.8% of patients permanently discontinued RYBREVANT® due to IRR. RYBREVANT ® as a Single Agent In CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range 0.1 to 18 hours) after start of infusion. The incidence of infusion modifications was 62% and 1.3% of patients permanently discontinued RYBREVANT® due to IRRs. Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT® as recommended. Administer RYBREVANT® via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT® based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT®. Interstitial Lung Disease/Pneumonitis RYBREVANT® can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. RYBREVANT ® with LAZCLUZE ® In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case (0.2%) of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT® and LAZCLUZE® due to ILD/pneumonitis. RYBREVANT ® with Carboplatin and Pemetrexed Based on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT® due to ILD/pneumonitis. RYBREVANT ® as a Single Agent In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT® due to ILD/pneumonitis. Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). For patients receiving RYBREVANT® in combination with LAZCLUZE®, immediately withhold both drugs in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed. For patients receiving RYBREVANT® as a single agent or in combination with carboplatin and pemetrexed, immediately withhold RYBREVANT® in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed. Venous Thromboembolic Events with Concomitant Use of RYBREVANT® and LAZCLUZE® RYBREVANT® in combination with LAZCLUZE® can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism (PE). Most events occurred during the first four months of therapy. In MARIPOSA, VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT®, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE®; 1% of patients had VTE leading to dose reductions of RYBREVANT®, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE®; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT®, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE®. The median time to onset of VTEs was 84 days (range: 6 to 777). Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended. Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT® and LAZCLUZE® based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT® and LAZCLUZE® at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT® and continue treatment with LAZCLUZE® at the same dose level at the discretion of the healthcare provider. Dermatologic Adverse Reactions RYBREVANT® can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus, and dry skin. RYBREVANT ® with LAZCLUZE ® In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT® and 30% for LAZCLUZE®, rash leading to dose reductions occurred in 23% of patients for RYBREVANT® and 19% for LAZCLUZE®, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT® and 1.7% for LAZCLUZE®. RYBREVANT ® with Carboplatin and Pemetrexed Based on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT® and 3.1% discontinued pemetrexed. RYBREVANT ® as a Single Agent In CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%). Instruct patients to limit sun exposure during and for 2 months after treatment with RYBREVANT® or LAZCLUZE® in combination with RYBREVANT®. Advise patients to wear protective clothing and use broad-spectrum UVA/UVB sunscreen. Alcohol-free (e.g., isopropanol-free, ethanol-free) emollient cream is recommended for dry skin. When initiating treatment, administer alcohol-free emollient cream to reduce the risk of dermatologic adverse reactions. Consider prophylactic measures (eg, use of oral antibiotics). If skin reactions develop, start topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT® in combination with LAZCLUZE®, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT® as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT® based on severity. Ocular Toxicity RYBREVANT® can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus, and uveitis. RYBREVANT ® with LAZCLUZE ® In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients. Withhold, reduce the dose, or permanently discontinue RYBREVANT® and continue LAZCLUZE® based on severity. RYBREVANT ® with Carboplatin and Pemetrexed Based on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2. RYBREVANT ® as a Single Agent In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2. Promptly refer patients with new or worsening eye symptoms to an ophthalmologist. Withhold, reduce the dose, or permanently discontinue RYBREVANT® based on severity. Embryo-Fetal Toxicity Based on animal models, RYBREVANT® and LAZCLUZE® can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT®, and for 3 weeks after the last dose of LAZCLUZE®. ADVERSE REACTIONS RYBREVANT ® with LAZCLUZE ® In MARIPOSA (n=421) , the most common adverse reactions (ARs) (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT®) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%). Serious ARs occurred in 49% of patients, with those occurring in ≥2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT®) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each). RYBREVANT ® with Carboplatin and Pemetrexed In MARIPOSA-2 (n=130), the most common ARs (≥20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%). In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each). In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%). In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified. RYBREVANT ® as a Single Agent In CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%). Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death. LAZCLUZE® Drug Interactions Avoid concomitant use of LAZCLUZE® with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4. Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate. Please read full Prescribing Information for RYBREVANT®. Please read full Prescribing Information for LAZCLUZE®. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at . Follow us at @JNJInnovMed. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of SC amivantamab and RYBREVANT® (amivantamab-vmjw). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 2Phase 3Phase 1

14 Oct 2025

·www.businesswire.com

Johnson & Johnson Reports Q3 2025 Results; Raises 2025 Sales Outlook

NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Johnson & Johnson (NYSE: JNJ) today announced results for third-quarter 2025. “Johnson & Johnson delivered another strong performance in the third quarter fueled by the depth and strength of our portfolio and significant progress across our pipeline,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “With a sharpened focus on the six priority areas of Oncology, Immunology, Neuroscience, Cardiovascular, Surgery and Vision, Johnson & Johnson is in a new era of accelerated growth and innovation, with pioneering treatments that will continue to transform lives.” Overall financial results Q3 ($ in Millions, except EPS) 2025 2024 % Change Reported Sales $23,993 $22,471 6.8% Net Earnings $5,152 $2,694 91.2% EPS (diluted) $2.12 $1.11 91.0% Q3 Non-GAAP* ($ in Millions, except EPS) 2025 2024 % Change Operational Sales1,2 5.4% Adjusted Operational Sales1,3 4.4% Adjusted Net Earnings1,4 $6,801 $5,876 15.7% Adjusted EPS (diluted)1,4 $2.80 $2.42 15.7% Free Cash Flow6,7 ~$14,200 $14,471 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine 6 Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings. 7 Third-quarter YTD 2025 is estimated as of October 14, 2025 Regional sales results Q3 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 U.S. $13,708 $12,909 6.2% 6.2 - 4.4 International 10,285 9,562 7.6 4.4 3.2 4.4 Worldwide $23,993 $22,471 6.8% 5.4 1.4 4.4 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Segment sales results Q3 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 Innovative Medicine $15,563 $14,580 6.8% 5.3 1.5 3.7 MedTech 8,430 7,891 6.8 5.6 1.2 5.7 Worldwide $23,993 $22,471 6.8% 5.4 1.4 4.4 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Third-Quarter 2025 segment commentary: Operational sales* reflected below excludes the impact of translational currency. Innovative Medicine Innovative Medicine worldwide operational sales grew 5.3%*, with net acquisitions and divestitures positively impacting growth by 1.6% due to CAPLYTA. Growth was primarily driven by DARZALEX, CARVYKTI, ERLEADA and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, and SPRAVATO in Neuroscience. Growth was partially offset by an approximate (1,070) basis points impact from STELARA in Immunology, as well as IMBRUVICA in Oncology. MedTech MedTech worldwide operational sales grew 5.6%*, with net acquisitions and divestitures negatively impacting growth by 0.1%. Growth was primarily driven by electrophysiology products, Abiomed and Shockwave in Cardiovascular, wound closure products in General Surgery, as well as Surgical Vision. Full-year 2025 guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) October 2025 July 2025 Adjusted Operational Sales1,2,5 Change vs. Prior Year / Mid-point 3.5% – 4.0% / 3.8% 3.2% – 3.7% / 3.5% Operational Sales2,5 / Mid-point Change vs. Prior Year / Mid-point $93.0B – $93.4B / $93.2B 4.8% – 5.3% / 5.1% $92.7B – $93.1B / $92.9B 4.5% – 5.0% / 4.8% Estimated Reported Sales3,5/ Mid-point Change vs. Prior Year / Mid-point $93.5B – $93.9B / $93.7B 5.4% – 5.9% / 5.7% $93.2B – $93.6B / $93.4B 5.1% – 5.6% / 5.4% Adjusted Operational EPS (Diluted)2,4 / Mid-point Change vs. Prior Year / Mid-point $10.63 – $10.73 / $10.68 6.5% – 7.5% / 7.0% $10.63 – $10.73 / $10.68 6.5% – 7.5% / 7.0% Adjusted EPS (Diluted)3,4 / Mid-point Change vs. Prior Year / Mid-point $10.80 – $10.90 / $10.85 8.2% – 9.2% / 8.7% $10.80 – $10.90 / $10.85 8.2% – 9.2% / 8.7% 1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures 2 Non-GAAP financial measure; excludes the impact of translational currency 3 Calculated using Euro Average Rate: Oct 2025 = $1.13 and July 2025 = $1.13 (Illustrative purposes only) 4 Non-GAAP financial measure; excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine Other modeling considerations will be provided on the webcast. Notable announcements in the quarter: The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at Investor News, as well as Innovative Medicine Newsroom, MedTech News & Events, and www.factsabouttalc.com. Regulatory U.S. FDA approves TREMFYA (guselkumab) for the treatment of pediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor1 Press Release TREMFYA (guselkumab) achieves U.S. approval for subcutaneous induction in adults with ulcerative colitis, now the first and only IL-23 inhibitor with a fully subcutaneous regimen Press Release Johnson & Johnson receives positive CHMP opinion of nipocalimab to treat a broad population of antibody-positive patients living with generalised myasthenia gravis (gMG) Press Release Johnson & Johnson files with U.S. FDA to include new evidence in TREMFYA (guselkumab) label as the only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in active psoriatic arthritis Press Release European Commission approves DARZALEX (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma Press Release European Commission approves IMBRUVICA (ibrutinib) as the first targeted therapy for patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant Press Release Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis Press Release Data Releases Johnson & Johnson to highlight breadth of its major depressive disorder portfolio at 2025 ECNP Congress1 Press Release Icotrokinra data in ulcerative colitis show potential for a standout combination of therapeutic benefit and a favorable safety profile in once-daily pill1 Press Release TREMFYA (guselkumab) is first and only IL-23 inhibitor to demonstrate sustained clinical and endoscopic outcomes with a fully subcutaneous regimen through 48 weeks in ulcerative colitis1 Press Release Johnson & Johnson Unveils New Data Demonstrating Superior Clarity of Vision and Comfort of ACUVUE OASYS MAX 1-Day for ASTIGMATISM, and MULTIFOCAL for ASTIGMATISM Contact Lenses1 Press Release Johnson & Johnson’s investigational seltorexant shows numerically higher response in patients with depression with insomnia symptoms, with fewer side effects compared to quetiapine XR Press Release TECVAYLI plus DARZALEX FASPRO treatment demonstrates 100 percent overall response rate in transplant-eligible patients newly diagnosed with multiple myeloma Press Release Icotrokinra shows superiority to deucravacitinib in first reported head-to-head trials reinforcing promise of novel targeted oral peptide for treatment of plaque psoriasis Press Release Johnson & Johnson to showcase industry-leading neuropsychiatry innovations at the 2025 Psych Congress Annual Meeting Press Release Data published in The New England Journal of Medicine demonstrate RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) is re-setting survival expectations in first-line EGFR-mutated lung cancer Press Release RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) prevents acquired resistance versus osimertinib in first-line EGFR-mutated non-small cell lung cancer Press Release New real-world data elevating patient perspectives highlight the need for scientific advancement in maternal fetal immunology at ISUOG 2025 Press Release Johnson & Johnson Unveils Results from the VARIPURE Substudy of SECURE, a Real-World Study on VARIPULSE Platform, at 2025 European Society of Cardiology (ESC) Congress Press Release New Data from the DanGer Shock Randomized Control Trial, Published in The New England Journal of Medicine, Confirms the Long-Term Survival Benefit of the Impella CP Heart Pump Press Release Johnson & Johnson showcases latest advancements in Alzheimer's research at AAIC 2025 Press Release Product Launch U.S. FDA approval of INLEXZO (gemcitabine intravesical system) set to transform how certain bladder cancers are treated Press Release Johnson & Johnson Launches VIRTUGUIDE AI-Powered Patient-Matched Lapidus System in U.S. to Reduce Complexity in Bunion Surgery for Millions Press Release Other Johnson & Johnson Elects John Morikis, Retired Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, to its Board of Directors Press Release 1 Subsequent to the quarter Webcast information: Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company's website at events-and-presentations. About Johnson & Johnson: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.jnj.com. Non-GAAP financial measures: * “Operational sales growth” excluding the impact of translational currency, “adjusted operational sales growth” excluding the net impact of acquisitions and divestitures and translational currency, as well as “adjusted net earnings”, “adjusted diluted earnings per share” and “adjusted operational diluted earnings per share” excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company's website at quarterly results. Copies of the financial schedules accompanying this earnings release are available on the company’s website at quarterly results. These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, an Innovative Medicine pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can also be found in the Investor Relations section of the company's website at quarterly results. Note to investors concerning forward-looking statements: This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, and market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations or changes to applicable laws and regulations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the Company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; and increased scrutiny of the health care industry by government agencies. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, investor.jnj.com, or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. THIRD QUARTER NINE MONTHS Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency $ 9,402 8,871 6.0 % 6.0 - $ 26,655 24,993 6.7 % 6.7 - 6,161 5,709 7.9 4.3 3.6 17,983 17,639 1.9 1.3 0.6 15,563 14,580 6.8 5.3 1.5 44,638 42,632 4.7 4.5 0.2 4,306 4,038 6.6 6.6 - 12,902 12,105 6.6 6.6 - 4,124 3,853 7.0 4.5 2.5 12,089 11,564 4.5 3.9 0.6 8,430 7,891 6.8 5.6 1.2 24,991 23,669 5.6 5.3 0.3 13,708 12,909 6.2 6.2 - 39,557 37,098 6.6 6.6 - 10,285 9,562 7.6 4.4 3.2 30,072 29,203 3.0 2.3 0.7 $ 23,993 22,471 6.8 % 5.4 1.4 $ 69,629 66,301 5.0 % 4.7 0.3 THIRD QUARTER NINE MONTHS Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency $ 13,708 12,909 6.2 % 6.2 - $ 39,557 37,098 6.6 % 6.6 - 5,440 4,914 10.7 4.4 6.3 15,937 15,291 4.2 1.5 2.7 1,231 1,173 4.9 7.3 (2.4 ) 3,604 3,579 0.7 7.6 (6.9 ) 3,614 3,475 4.0 3.4 0.6 10,531 10,333 1.9 1.8 0.1 10,285 9,562 7.6 4.4 3.2 30,072 29,203 3.0 2.3 0.7 $ 23,993 22,471 6.8 % 5.4 1.4 $ 69,629 66,301 5.0 % 4.7 0.3 2025 2024 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 23,993 100.0 $ 22,471 100.0 6.8 7,303 30.4 6,963 31.0 4.9 16,690 69.6 15,508 69.0 7.6 5,922 24.7 5,478 24.3 8.1 3,672 15.3 4,952 22.0 (25.8 ) 18 0.1 (99 ) (0.4 ) (478 ) (2.0 ) 1,798 8.0 63 0.3 41 0.2 7,493 31.2 3,338 14.9 124.5 2,341 9.7 644 2.9 263.5 $ 5,152 21.5 $ 2,694 12.0 91.2 $ 2.12 $ 1.11 91.0 2,428.6 2,427.9 31.2 % 19.3 % $ 8,436 35.2 $ 7,277 32.4 15.9 $ 6,801 28.3 $ 5,876 26.1 15.7 $ 2.80 $ 2.42 15.7 19.4 % 19.3 % 2025 2024 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 69,629 100.0 $ 66,301 100.0 5.0 22,288 32.0 20,343 30.7 9.6 47,341 68.0 45,958 69.3 3.0 16,923 24.3 16,416 24.8 3.1 10,413 15.0 11,934 18.0 (12.7 ) - - 194 0.3 (62 ) (0.1 ) (433 ) (0.7 ) (7,692 ) (11.1 ) 4,855 7.3 144 0.2 192 0.3 27,615 39.7 12,800 19.3 115.7 5,927 8.6 2,165 3.3 173.8 $ 21,688 31.1 $ 10,635 16.0 103.9 $ 8.94 $ 4.38 104.1 2,424.8 2,429.5 21.5 % 16.9 % $ 24,635 35.4 $ 23,558 35.5 4.6 $ 20,206 29.0 $ 19,296 29.1 4.7 $ 8.33 $ 7.94 4.9 18.0 % 18.1 % Third Quarter Nine Months Ended 2025 2024 2025 2024 $5,152 $2,694 $21,688 $10,635 15 2,388 (6,894 ) 5,466 1,048 1,171 3,435 3,355 - 4 - 77 168 47 302 207 - 38 - 157 97 328 475 928 (387 ) (37 ) (327 ) 374 - - - 194 2 - 29 - (168 ) (762 ) 826 (2,055 ) 874 5 672 (42 ) $6,801 $5,876 $20,206 $19,296 2,428.6 2,427.9 2,424.8 2,429.5 $2.80 $2.42 $8.33 $7.94 $2.72 $8.24 1 2 6.8% 6.8% 6.8% 6.0% 6.6% 6.2% 7.9% 7.0% 7.6% 1.5 1.2 1.4 - - - 3.6 2.5 3.2 5.3% 5.6% 5.4% 6.0% 6.6% 6.2% 4.3% 4.5% 4.4% (1.6) (1.1) (2.7) (1.9) 0.0 0.0 0.0 0.1 0.1 0.0 0.2 0.1 0.0 0.1 0.0 3.7% 5.7% 4.4% 3.3% 6.8% 4.4% 4.3% 4.6% 4.4% 4.7% 5.6% 5.0% 6.7% 6.6% 6.6% 1.9% 4.5% 3.0% 0.2 0.3 0.3 - - - 0.6 0.6 0.7 4.5% 5.3% 4.7% 6.7% 6.6% 6.6% 1.3% 3.9% 2.3% (1.9) (0.6) (2.9) (0.9) (0.8) (0.2) (1.1) (0.7) (1.8) (1.2) 0.0 0.0 0.0 0.3 0.1 0.0 0.4 0.1 0.1 0.2 0.1 3.4% 3.7% 3.5% 4.9% 4.1% 4.6% 1.4% 3.3% 2.2% REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 3,468 2,816 23.2 % 23.2 % - $ 9,866 7,835 25.9 % 25.9 % - 3,060 2,565 19.3 % 14.8 % 4.5 % 8,652 7,450 16.1 % 15.0 % 1.1 % 6,529 5,380 21.3 % 19.2 % 2.1 % 18,519 15,284 21.2 % 20.6 % 0.6 % 396 258 53.3 % 53.3 % - 1,072 565 89.6 % 89.6 % - 128 27 * * * 260 63 * * * 524 286 83.5 % 81.4 % 2.1 % 1,332 629 * * * 2,088 1,684 24.0 % 24.0 % - 5,934 4,789 23.9 % 23.9 % - 1,584 1,332 18.9 % 14.7 % 4.2 % 4,514 3,797 18.9 % 17.9 % 1.0 % 3,672 3,016 21.7 % 19.9 % 1.8 % 10,448 8,586 21.7 % 21.3 % 0.4 % 378 337 12.3 % 12.3 % - 1,048 940 11.5 % 11.5 % - 558 453 23.0 % 17.6 % 5.4 % 1,567 1,275 22.9 % 21.1 % 1.8 % 936 790 18.4 % 15.3 % 3.1 % 2,615 2,215 18.0 % 17.0 % 1.0 % 211 259 (18.3 )% (18.3 )% - 685 770 (11.0 )% (11.0 )% - 483 494 (2.3 )% (6.6 )% 4.3 % 1,453 1,537 (5.4 )% (6.4 )% 1.0 % 695 753 (7.8 )% (10.6 )% 2.8 % 2,139 2,307 (7.3 )% (7.9 )% 0.6 % 136 68 99.7 % 99.7 % - 388 156 * * - 61 21 * * * 130 49 * * * 198 89 * * * 518 205 * * * 85 64 34.2 % 34.2 % - 235 173 35.8 % 35.8 % - 37 12 * * * 79 29 * * * 122 75 60.8 % 59.1 % 1.7 % 314 202 55.3 % 54.9 % 0.4 % 115 105 9.3 % 9.3 % - 334 310 7.5 % 7.5 % - 62 30 * * * 160 93 73.0 % 72.6 % 0.4 % 177 135 31.3 % 29.9 % 1.4 % 494 403 22.6 % 22.5 % 0.1 % 5 5 (25.0 )% (25.0 )% - 18 25 (30.4 )% (30.4 )% - 108 144 (25.1 )% (26.8 )% 1.7 % 365 470 (22.3 )% (23.0 )% 0.7 % 113 150 (25.1 )% (26.8 )% 1.7 % 383 496 (22.8 )% (23.4 )% 0.6 % 56 36 54.6 % 54.6 % - 153 106 44.8 % 44.8 % - 39 50 (22.2 )% (25.6 )% 3.4 % 123 136 (9.7 )% (10.6 )% 0.9 % 94 86 9.7 % 7.7 % 2.0 % 276 242 14.0 % 13.6 % 0.4 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 2,676 3,068 (12.8 )% (12.8 )% - $ 7,377 8,499 (13.2 )% (13.2 )% - 1,493 1,552 (3.9 )% (6.3 )% 2.4 % 4,492 5,090 (11.8 )% (11.5 )% (0.3 )% 4,168 4,621 (9.8 )% (10.6 )% 0.8 % 11,868 13,590 (12.7 )% (12.6 )% (0.1 )% 326 281 16.2 % 16.2 % - 923 778 18.7 % 18.7 % - 19 27 (30.9 )% (30.9 )% - 63 89 (29.6 )% (29.6 )% - 132 112 17.7 % 16.7 % 1.0 % 413 380 8.6 % 10.4 % (1.8 )% 476 419 13.6 % 13.3 % 0.3 % 1,398 1,246 12.2 % 12.7 % (0.5 )% 309 299 3.6 % 3.6 % - 906 820 10.5 % 10.5 % - 377 218 73.0 % 69.8 % 3.2 % 1,130 787 43.5 % 44.6 % (1.1 )% 687 516 32.9 % 31.5 % 1.4 % 2,036 1,607 26.7 % 27.2 % (0.5 )% 1,022 1,770 (42.3 )% (42.3 )% - 3,081 5,021 (38.6 )% (38.6 )% - 549 906 (39.4 )% (41.4 )% 2.0 % 1,768 2,991 (40.9 )% (40.8 )% (0.1 )% 1,570 2,676 (41.3 )% (42.0 )% 0.7 % 4,848 8,012 (39.5 )% (39.5 )% 0.0 % 989 691 43.1 % 43.1 % - 2,384 1,789 33.3 % 33.3 % - 434 316 37.4 % 33.4 % 4.0 % 1,181 932 26.7 % 26.1 % 0.6 % 1,424 1,007 41.3 % 40.1 % 1.2 % 3,566 2,721 31.0 % 30.8 % 0.2 % 12 1 * * - 21 3 * * - 0 0 - - - 0 0 - - - 12 1 * * - 21 3 * * - 1,367 1,094 25.0 % 25.0 % - 3,712 3,250 14.2 % 14.2 % - 658 662 (0.7 )% (2.6 )% 1.9 % 2,011 2,090 (3.8 )% (3.7 )% (0.1 )% 2,024 1,755 15.3 % 14.6 % 0.7 % 5,722 5,340 7.2 % 7.2 % 0.0 % 240 - * * - 451 - * * - - - - - - - - - - - 240 - * * - 451 - * * - 14 26 (49.2 )% (49.2 )% - 76 101 (24.9 )% (24.9 )% - 127 117 9.0 % 8.5 % 0.5 % 376 382 (1.4 )% (0.4 )% (1.0 )% 140 142 (1.4 )% (1.8 )% 0.4 % 452 482 (6.3 )% (5.5 )% (0.8 )% 664 780 (14.9 )% (14.9 )% - 2,021 2,329 (13.2 )% (13.2 )% - 267 269 (0.9 )% (3.0 )% 2.1 % 804 830 (3.1 )% (3.0 )% (0.1 )% 929 1,049 (11.3 )% (11.9 )% 0.6 % 2,824 3,159 (10.6 )% (10.5 )% (0.1 )% 405 243 67.1 % 67.1 % - 1,047 660 58.7 % 58.7 % - 53 42 28.9 % 23.8 % 5.1 % 146 120 21.9 % 21.4 % 0.5 % 459 284 61.5 % 60.8 % 0.7 % 1,193 780 53.0 % 52.9 % 0.1 % 46 46 0.4 % 0.4 % - 119 161 (26.4 )% (26.4 )% - 210 235 (10.7 )% (12.3 )% 1.6 % 684 759 (9.8 )% (9.9 )% 0.1 % 256 281 (8.9 )% (10.2 )% 1.3 % 803 920 (12.7 )% (12.8 )% 0.1 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 815 815 (0.1 )% (0.1 )% - $ 2,358 2,324 1.5 % 1.5 % - 300 287 4.8 % 2.0 % 2.8 % 895 866 3.4 % 2.6 % 0.8 % 1,115 1,102 1.1 % 0.4 % 0.7 % 3,253 3,190 2.0 % 1.8 % 0.2 % 409 417 (1.6 )% (1.6 )% - 1,175 1,149 2.3 % 2.3 % - 168 166 1.1 % (1.8 )% 2.9 % 507 506 0.2 % (0.7 )% 0.9 % 578 583 (0.8 )% (1.7 )% 0.9 % 1,682 1,655 1.7 % 1.4 % 0.3 % 392 379 3.5 % 3.5 % - 1,139 1,120 1.7 % 1.7 % - 92 80 15.2 % 12.0 % 3.2 % 272 232 17.0 % 16.4 % 0.6 % 484 458 5.6 % 5.0 % 0.6 % 1,411 1,352 4.3 % 4.2 % 0.1 % 13 21 (36.5 )% (36.5 )% - 44 56 (21.5 )% (21.5 )% - 39 39 (1.0 )% (2.5 )% 1.5 % 116 127 (8.9 )% (9.1 )% 0.2 % 53 60 (13.1 )% (14.1 )% 1.0 % 160 183 (12.7 )% (12.9 )% 0.2 % 326 365 (10.5 )% (10.5 )% - 961 1,023 (6.0 )% (6.0 )% - 501 471 6.4 % 0.5 % 5.9 % 1,472 1,599 (7.9 )% (9.8 )% 1.9 % 829 836 (0.9 )% (4.3 )% 3.4 % 2,434 2,622 (7.2 )% (8.3 )% 1.1 % 7 8 (7.9 )% (7.9 )% - 21 24 (11.8 )% (11.8 )% - 378 323 16.9 % 9.9 % 7.0 % 1,082 926 16.8 % 13.6 % 3.2 % 385 330 16.4 % 9.5 % 6.9 % 1,103 950 16.1 % 13.0 % 3.1 % 315 355 (11.0 )% (11.0 )% - 932 990 (5.8 )% (5.8 )% - 81 94 (13.6 )% (18.5 )% 4.9 % 264 315 (16.1 )% (16.6 )% 0.5 % 397 449 (11.6 )% (12.6 )% 1.0 % 1,196 1,305 (8.3 )% (8.4 )% 0.1 % 4 3 57.3 % 57.3 % - 8 10 (11.0 )% (11.0 )% - 42 54 (21.2 )% (22.3 )% 1.1 % 126 358 (64.7 )% (64.6 )% (0.1 )% 47 56 (17.5 )% (18.5 )% 1.0 % 135 367 (63.3 )% (63.2 )% (0.1 )% 750 713 5.3 % 5.3 % - 2,381 2,061 15.5 % 15.5 % - 149 170 (13.1 )% (15.6 )% 2.5 % 461 543 (15.2 )% (14.7 )% (0.5 )% 899 884 1.7 % 1.2 % 0.5 % 2,842 2,605 9.1 % 9.2 % (0.1 )% 635 592 7.4 % 7.4 % - 1,946 1,697 14.7 % 14.7 % - - - - - - - - - - - 635 592 7.4 % 7.4 % - 1,946 1,697 14.7 % 14.7 % - 115 121 (5.2 )% (5.2 )% - 435 364 19.4 % 19.4 % - 149 170 (13.1 )% (15.6 )% 2.5 % 461 543 (15.2 )% (14.7 )% (0.5 )% 264 292 (9.8 )% (11.3 )% 1.5 % 896 908 (1.3 )% (1.0 )% (0.3 )% 9,402 8,871 6.0 % 6.0 % - 26,655 24,993 6.7 % 6.7 % - 6,161 5,709 7.9 % 4.3 % 3.6 % 17,983 17,639 1.9 % 1.3 % 0.6 % $ 15,563 14,580 6.8 % 5.3 % 1.5 % $ 44,638 42,632 4.7 % 4.5 % 0.2 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 1,306 1,148 13.8 % 13.8 % - $ 3,931 3,292 19.4 % 19.4 % - 908 819 10.8 % 8.4 % 2.4 % 2,698 2,353 14.6 % 13.8 % 0.8 % 2,213 1,966 12.6 % 11.6 % 1.0 % 6,629 5,645 17.4 % 17.1 % 0.3 % 720 660 9.1 % 9.1 % - 2,145 2,057 4.3 % 4.3 % - 698 619 12.6 % 10.4 % 2.2 % 2,064 1,889 9.2 % 8.6 % 0.6 % 1,418 1,279 10.8 % 9.7 % 1.1 % 4,209 3,946 6.7 % 6.4 % 0.3 % 336 293 14.5 % 14.5 % - 1,035 905 14.3 % 14.3 % - 86 68 26.8 % 20.2 % 6.6 % 256 207 23.9 % 20.7 % 3.2 % 423 362 16.8 % 15.6 % 1.2 % 1,291 1,112 16.1 % 15.5 % 0.6 % 220 163 34.4 % 34.4 % - 659 240 * * - 59 66 (11.2 )% (12.4 )% 1.2 % 169 66 * * * 278 229 21.2 % 20.9 % 0.3 % 828 306 * * * 30 30 0.0 % 0.0 % - 93 89 4.2 % 4.2 % - 65 66 (1.0 )% (2.5 )% 1.5 % 209 192 9.0 % 8.7 % 0.3 % 95 96 (0.7 )% (1.7 )% 1.0 % 302 281 7.5 % 7.2 % 0.3 % 1,396 1,359 2.7 % 2.7 % - 4,200 4,229 (0.7 )% (0.7 )% - 878 832 5.6 % 1.9 % 3.7 % 2,620 2,614 0.3 % (1.1 )% 1.4 % 2,274 2,191 3.8 % 2.4 % 1.4 % 6,820 6,843 (0.3 )% (0.8 )% 0.5 % 262 250 4.7 % 4.7 % - 796 785 1.3 % 1.3 % - 144 131 9.7 % 5.9 % 3.8 % 440 435 1.2 % 0.0 % 1.2 % 405 381 6.4 % 5.1 % 1.3 % 1,235 1,220 1.3 % 0.9 % 0.4 % 216 212 2.1 % 2.1 % - 673 684 (1.5 )% (1.5 )% - 160 140 14.3 % 10.9 % 3.4 % 482 463 4.0 % 3.0 % 1.0 % 377 352 7.0 % 5.6 % 1.4 % 1,155 1,147 0.7 % 0.3 % 0.4 % 512 497 3.0 % 3.0 % - 1,515 1,499 1.1 % 1.1 % - 281 265 6.4 % 2.5 % 3.9 % 818 786 4.1 % 2.7 % 1.4 % 793 761 4.2 % 2.9 % 1.3 % 2,333 2,285 2.1 % 1.6 % 0.5 % 406 400 1.3 % 1.3 % - 1,216 1,262 (3.7 )% (3.7 )% - 293 296 (1.1 )% (4.8 )% 3.7 % 881 930 (5.3 )% (6.8 )% 1.5 % 698 696 0.3 % (1.3 )% 1.6 % 2,096 2,191 (4.3 )% (5.0 )% 0.7 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 1,031 983 4.9 % 4.9 % - $ 3,076 2,965 3.8 % 3.8 % - 1,511 1,451 4.1 % 2.2 % 1.9 % 4,417 4,373 1.0 % 0.9 % 0.1 % 2,542 2,434 4.4 % 3.3 % 1.1 % 7,493 7,338 2.1 % 2.1 % 0.0 % 477 448 6.2 % 6.2 % - 1,411 1,360 3.7 % 3.7 % - 688 661 4.2 % 2.1 % 2.1 % 1,991 1,977 0.7 % 0.5 % 0.2 % 1,165 1,109 5.0 % 3.8 % 1.2 % 3,402 3,337 1.9 % 1.8 % 0.1 % 555 535 3.8 % 3.8 % - 1,666 1,605 3.8 % 3.8 % - 823 791 4.0 % 2.2 % 1.8 % 2,426 2,397 1.2 % 1.3 % (0.1 )% 1,378 1,325 3.9 % 2.9 % 1.0 % 4,092 4,001 2.3 % 2.3 % 0.0 % 571 549 4.2 % 4.2 % - 1,694 1,619 4.7 % 4.7 % - 828 751 10.2 % 7.5 % 2.7 % 2,354 2,224 5.8 % 5.0 % 0.8 % 1,400 1,300 7.7 % 6.1 % 1.6 % 4,048 3,843 5.3 % 4.8 % 0.5 % 456 441 3.5 % 3.5 % - 1,337 1,288 3.8 % 3.8 % - 562 527 6.6 % 3.4 % 3.2 % 1,565 1,508 3.8 % 2.4 % 1.4 % 1,018 968 5.2 % 3.5 % 1.7 % 2,902 2,796 3.8 % 3.1 % 0.7 % 116 108 7.0 % 7.0 % - 358 331 8.0 % 8.0 % - 266 225 18.7 % 17.1 % 1.6 % 789 717 10.1 % 10.3 % (0.2 )% 383 333 14.9 % 13.8 % 1.1 % 1,147 1,048 9.4 % 9.6 % (0.2 )% 4,306 4,038 6.6 % 6.6 % - 12,902 12,105 6.6 % 6.6 % - 4,124 3,853 7.0 % 4.5 % 2.5 % 12,089 11,564 4.5 % 3.9 % 0.6 % $ 8,430 7,891 6.8 % 5.6 % 1.2 % $ 24,991 23,669 5.6 % 5.3 % 0.3 % GAAP to Non-GAAP Reconciliation $ in Millions Third Quarter Sept 28, 2025 GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related Other Third Quarter Sept 28, 2025 Non-GAAP $ 3,672 (568 ) (11 ) 3,093 2,869 2,869 2,944 2,944 (368 ) 5 (48 ) 174 (1 ) (238 ) 6,446 568 (5 ) - 59 (174 ) - 1 6,895 $ 3,612 (480 ) (12 ) (1 ) 3,119 2,801 2,801 728 728 2 5 (156 ) (48 ) 213 (1 ) 15 1,287 480 (5 ) 168 49 (213 ) - 1 1,767 $ 19 19 252 252 - - (31 ) (25 ) 11 (45 ) (240 ) - 25 - (11 ) - - - (226 ) $ 7,303 (1,048 ) (12 ) (12 ) 6,231 5,922 5,922 3,672 3,672 (478 ) (15 ) (93 ) (85 ) 387 (2 ) (286 ) - - 18 18 63 (63 ) - 7,493 1,048 15 168 97 (387 ) - 2 8,436 2,341 193 3 34 16 (87 ) (874 ) 9 1,635 5,152 855 12 134 81 (300 ) 874 (7 ) 6,801 GAAP to Non-GAAP Reconciliation $ in Millions $ 3,549 (695 ) (2 ) 2,852 2,491 2,491 4,213 (2 ) 4,211 (155 ) (356 ) (19 ) (6 ) 41 (495 ) 4,482 695 356 19 6 (41 ) - 4 - 5,521 $ 3,381 (476 ) (6 ) (156 ) (16 ) 2,727 2,723 (3 ) 2,720 739 (36 ) (19 ) 684 (11 ) (19 ) (22 ) (85 ) (4 ) (141 ) 1,059 476 19 28 277 4 38 - - 1,901 $ 33 33 264 264 - - 1,906 (2,013 ) (45 ) (152 ) (2,203 ) - 2,013 - 45 - - - - (145 ) $ 6,963 (1,171 ) (6 ) (156 ) (16 ) (2 ) 5,612 5,478 (3 ) 5,475 4,952 (36 ) (19 ) (2 ) 4,895 1,798 (2,388 ) (136 ) 37 (689 ) - - (99 ) (99 ) 41 (41 ) - 3,338 1,171 2,388 47 328 (37 ) 38 4 - 7,277 644 169 527 9 59 (9 ) 6 1 (5 ) 1,401 2,694 1,002 1,861 38 269 (28 ) 32 3 5 5,876 Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions $ 11,670 (2,002 ) (24 ) 9,644 7,919 7,919 8,361 8,361 (520 ) 74 (275 ) 164 (14 ) (571 ) 17,208 2,002 (74 ) - 299 (164 ) - 14 19,285 $ 10,576 (1,433 ) (35 ) (52 ) 9,056 8,319 8,319 2,052 37 2,089 132 (78 ) (267 ) (155 ) 163 (15 ) (220 ) 3,912 1,433 78 302 170 (163 ) - 15 5,747 $ 42 42 685 685 - - (7,222 ) 6,898 (6 ) (330 ) 6,495 - (6,898 ) - 6 - - - (397 ) $ 22,288 (3,435 ) (35 ) (76 ) 18,742 16,923 16,923 10,413 37 10,450 (7,692 ) 6,894 (123 ) (436 ) 327 (29 ) (1,059 ) - - (62 ) (62 ) 144 (144 ) - 27,615 3,435 (6,894 ) 302 475 (327 ) - 29 24,635 5,927 603 (1,541 ) 58 118 (73 ) (672 ) 9 4,429 21,688 2,832 (5,353 ) 244 357 (254 ) 672 20 20,206 Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions $ 10,522 (2,087 ) (8 ) 8,427 7,594 7,594 9,831 (19 ) 9,812 (225 ) (399 ) (194 ) (100 ) (54 ) 26 (50 ) (996 ) 14,910 2,087 399 194 100 54 (26 ) - 77 - 17,795 $ 9,749 (1,268 ) (15 ) (206 ) (66 ) 8,194 7,976 (12 ) 7,964 2,103 (69 ) (79 ) 1,955 173 (15 ) (92 ) (472 ) (48 ) (454 ) 3,668 1,268 15 - 107 747 48 157 - - 6,010 $ 72 72 846 846 - - 4,860 (5,052 ) (127 ) (352 ) (671 ) (5,778 ) - 5,052 - - 127 352 - - - (247 ) $ 20,343 (3,355 ) (15 ) (206 ) (66 ) (8 ) 16,693 16,416 (12 ) 16,404 11,934 (69 ) (79 ) (19 ) 11,767 4,855 (5,466 ) (653 ) (374 ) (50 ) (1,688 ) 194 (194 ) - (433 ) (433 ) 192 (192 ) - 12,800 3,355 5,466 194 207 928 374 157 77 - 23,558 2,165 473 1,224 43 42 222 5 29 17 42 4,262 10,635 2,882 4,242 151 165 706 369 128 60 (42 ) 19,296

Drug ApprovalFinancial Statement

08 Sep 2025

·endpoints.news

AstraZeneca's rivalry with J&J in certain lung cancer patients heats up as it reports Tagrisso combo survival data

The combination of AstraZeneca’s Tagrisso and chemotherapy cut the risk of death by 23% compared to Tagrisso alone for patients with advanced EGFR-mutant lung cancer. In the FLAURA2 study’s key overall survival endpoint, patients who received the combination lived for a median of 47.5 months, or almost four years, after starting treatment. By contrast, those who received Tagrisso alone had a median survival time of 37.6 months. The data, which included 557 patients, were presented on Sunday at the annual World Conference on Lung Cancer in Barcelona. In this multibillion-dollar lung cancer market, AstraZeneca’s approach is being closely compared with Johnson & Johnson’s Rybrevant plus Lazcluze, which is under investigation in the MARIPOSA trial. And AstraZeneca’s Sunday result is slightly worse than what Wall Street analysts were looking for. Leerink Partners analyst Andrew Berens wrote in an August note that investors “will be looking to see [a hazard ratio] of 0.75 or lower, which would suggest similar or better survival than JNJ’s MARIPOSA regimen.” AstraZeneca reported a hazard ratio of 0.77. J&J announced in January that its combination beat Tagrisso alone on survival in the MARIPOSA study, but has not divulged its median OS endpoint yet. The company previously disclosed that, at the final OS analysis with a median follow-up of 37.8 months, the median OS for its combination was not yet reached, but the hazard ratio was 0.75. That means the combination cut the risk of death by 25% compared to Tagrisso alone. In a Thursday release, J&J oncology head Yusri Elsayed said the survival time with the Rybrevant and Lazcluze combination is “projected to exceed four years” compared to the three-year survival it reported with the Tagrisso arm. “Those other numbers” are “just purely projections,” said Dave Fredrickson, EVP of AstraZeneca’s oncology business unit, when Endpoints News asked about what J&J disclosed about its median OS result. “The FLAURA2 data are the only reported median overall survival data. And those data, again, they’re definitive, they’re statistically significant.” AstraZeneca and J&J are contending for their combinations to become the go-to approach in the EGFR mutant non-small cell lung cancer market. The current standard treatment option is Tagrisso alone, although the FDA approved both combinations for EGFR-mutated non-small cell lung cancer last year. Tagrisso generated $6.58 billion in revenue last year. On progression-free survival, AstraZeneca previously reported that its drug combination kept cancer at bay for 25.5 months, while Johnson & Johnson said its approach did so for 23.7 months. However, both combinations add toxicities compared to Tagrisso alone, and physicians have to decide which regimen may be best for different patients. AstraZeneca said on Sunday that no new safety signals were reported, but there was one additional treatment-related death in the Tagrisso-only arm.

Clinical Result

100 Deals associated with Lazertinib Mesylate

External Link

KEGG	Wiki	ATC	Drug Bank
D11980	-	-	DB16216

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
EGFR-mutated non-small Cell Lung Cancer	Japan	Janssen Pharmaceutical KK	27 Mar 2025
Non-Small Cell Lung Cancer	Canada	Janssen, Inc.	06 Mar 2025
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	South Korea	Yuhan Corp.	18 Jan 2021
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	South Korea	Yuhan Corp.	18 Jan 2021
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	South Korea	Yuhan Corp.	18 Jan 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Japan	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Argentina	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Australia	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Brazil	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Canada	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	France	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Germany	Janssen Research & Development LLC	05 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Israel	Janssen Research & Development LLC	05 Aug 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04487080 (MARIPOSA, PRNewswire) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer First line EGFR L858R \| EGFR Exon 19 Deletion	1,074	埃万妥单抗+兰泽替尼	ysfvjbjrti(qfvkcofgnk) = 化疗联合方案达到了预设最终次要终点 OS，并显示出相较于奥希替尼单药治疗具有统计学显著性以及临床意义上的改善。 ylhbxcronc (sumgphfhpx ) Met View more	Positive	12 Sep 2025
				奥希替尼
NCT04077463 (CHRYSALIS-2, WCLC2025)	Phase 1	Advanced Lung Non-Small Cell Carcinoma Second line EGFR sensitive mutation (Ex19del, L858R)	132	Amivantamab+lazertinib (Cohort E；MET+)	jfhbvejosj(hpssuugbxo) = jfbmjdjddw vvnsurvjhb (radqphfwzy, 14 - 50) View more	Positive	09 Sep 2025
				Amivantamab+lazertinib (Cohort E；MET-)	jfhbvejosj(hpssuugbxo) = hhicwgfnxm vvnsurvjhb (radqphfwzy, 6 - 29) View more
NCT04487080 (MARIPOSA, GlobeNewswire) Manual	Phase 3	EGFR Mutation Lung Cancer First line EGFR exon 19 deletions \| EGFR L858R	-	Amivantamab + Lazertinib	jurjikgutk(ccnohcpvvc) = zcssbebntx xzzizqleoe (tlhhujaxwm, 42.9 - NE) Not Met View more	Positive	07 Sep 2025
				Osimertinib monotherapy	jurjikgutk(ccnohcpvvc) = armevbkjun xzzizqleoe (tlhhujaxwm ) Not Met View more
LASER301 (AACR 12025 \| AACR 22025)	Phase 3	-	168	Lazertinib	jsyhbcfivg(eltfjuxyko) = gngvwrogbm jaswvxxfpp (bmelogtsjo ) View more	Positive	28 Apr 2025
NCT04988295 (MARIPOSA-2, CTgov)	Phase 3	EGFR-mutated non-small Cell Lung Cancer	776	ACP-L+Amivantamab+Carboplatin+Pemetrexed+Lazertinib (Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L))	abdijijowo(cvwiktrech) = ghslgckgso ftwqgkvxxb (sczdlpkqoz, xscozhnuoq - lalgfttpkw) View more	-	16 Apr 2025
				Carboplatin+Pemetrexed (CP) (Main Study: Arm B: Carboplatin + Pemetrexed (CP))	abdijijowo(cvwiktrech) = nygwvflhna ftwqgkvxxb (sczdlpkqoz, uheukvkplj - ajbqcnwueg) View more
NCT06120140 (COCOON, ESMO_ELCC2025) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR Exon 19 Deletion \| EGFR L858R	138	amivantamab+lazertinib	mvtuwymwpz(byzhluypym) = sbyzrzjajs hasmlemvqk (cjsotcwelr ) Met View more	Positive	27 Mar 2025
				SoC	mvtuwymwpz(byzhluypym) = itsgxrzmev hasmlemvqk (cjsotcwelr ) Met View more
NCT05601973 (AMAZE-lung, ESMO_ELCC2025) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	61	Amivantamab+lazertinib+bevacizumab	iexuqvteou(siydzqbtwu) = zngeggbbfb tojghaueek (hqksfxmuim, 21 - 47) Met View more	Positive	27 Mar 2025
NCT04487080 (MARIPOSA, ESMO_ELCC2025) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer First line EGFR L858R \| EGFR Exon 19 Deletion	-	Amivantamab plus Lazertinib	eaqqkyvzlm(yelonrsynf) = zpxxmelxed lekksgeyfk (yosktjgxrb, 42.9 - NE) View more	Positive	26 Mar 2025
				Osimertinib	eaqqkyvzlm(yelonrsynf) = tpxkenymsn lekksgeyfk (yosktjgxrb, 33.4 - 41.0) View more
NCT04077463 (CHRYSALIS-2, ESMO_ELCC2025) Manual	Phase 1	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	49	Amivantamab plus Lazertinib	kgrywxpmru(yrehhlysqr) = agdigmtvbm jlrgsalpxc (tbffessyqr ) View more	Positive	26 Mar 2025
				EGFR TKIs (Osimertinib, Afatinib)	kgrywxpmru(yrehhlysqr) = axjdwbvmwi jlrgsalpxc (tbffessyqr ) View more
NCT05469022 (ESMO_ELCC2025)	Phase 2	Lung Cancer Neoadjuvant \| Adjuvant EGFR mutations	128	Neoadjuvant lazertinib therapy	qswitteetg(unvxlhjety) = pyudaohsjd eihkqtahzs (pdgbqgtrfm ) View more	Positive	26 Mar 2025

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