Radiation therapy improves cancer cure rates by killing cancer cells but it also contributes to long-term side effects in cancer survivors by unintentionally damaging normal organs such as the intestine. This research will what side effects patients with cancer experience, if high dose vitamin C helps reduce these side effects, and if high dose vitamin C increases the survival of patients with pancreatic cancer. We will meet with patients during the study to better understand their experience during their cancer treatment. In the long term, our research could provide a new way help cancer survivors avoid many permanent side effects of cancer treatments.

Start Date31 Dec 2025

Sponsor / Collaborator

The Holden Comprehensive Cancer Center

NCT05700448

/ Not yet recruitingPhase 3

A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL)

The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.

Start Date01 Jun 2025

Sponsor / Collaborator

Cornerstone Pharmaceutical Co., Ltd

NCT05562297

/ Not yet recruitingPhase 2IIT

A Phase II Study to Evaluate the Safety and Efficacy of Sintilimab Combined with Nab-paclitaxel and Gemcitabine for Neoadjuvant and Adjuvant Therapy of Patients with Resectable and Borderline Resectable Pancreatic Cancer

The purpose of this research is to investigate the activity and safety of the combination of gemcitabine plus nab-paclitaxel and sintilimab as neoadjuvant therapy in treating patients with resectable and borderline resectable pancreatic cancer.
The drugs involved in this study are:
* Sintilimab
* Nab-paclitaxel
* Gemcitabine

Start Date20 Mar 2025

Sponsor / Collaborator

Zhongshan Hospital Fudan University

[+1]

100 Clinical Results associated with Gemcitabine Hydrochloride

100 Translational Medicine associated with Gemcitabine Hydrochloride

100 Patents (Medical) associated with Gemcitabine Hydrochloride

577

Literatures (Medical) associated with Gemcitabine Hydrochloride

01 Mar 2025·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Chemical and biological investigations on modified gemcitabine by nanoliposome structured on cholesterol, pectin, and phosphatidylcholine as an anticancer drug via a drug delivery system

Article

Author: Alamri, Saad A ; Mostafa, Yasser S ; El-Shafai, Nagi M ; Zaghloul, Asmaa ; Shukry, Mustafa ; Emira, Amal ; El-Mehasseb, Ibrahim

Gemcitabine hydrochloride (GEM) mimics one of the building blocks of DNA and RNA, so it indicates possible chemotherapeutic effects. It prevents cancer cells from producing DNA and proteins, which ultimately leads to their death. The goal of this work is to modify the GEM medication by nanoforming nanoliposomes based on the composition of Cholesterol, pectin nanoparticles, and phosphatidylcholine (PhC). The drug in nanoliposome form is made using the precipitation method, and several approaches are employed to characterize it. UV-Vis spectroscopy is used to measure the release process of GEM from the lipids and its integration with them. Results of the combination efficiency for PhC.Pectin@GEM, PhC.GEM@Pectin, and PhC@Cholestrol.GEM were recorded at 78.8 %, 83 %, and 80 %, respectively. A UV-Vis spectrophotometer was used to determine the release efficiency of the nanoliposomes, which was measured at pH values of 3, 6.8, and 7.4. The in-vitro investigation employed SRB (Routine analysis IC₅₀) to determine the modified drug's toxicity on breast adenocarcinoma (MCF-7) cells, while the in-vitro study assessed the produced nanoliposomes' capacity to do so. The conclusion is that to ascertain whether GEM medicine's nanoliposomes can effectively treat breast cancer in place of GEM medication, clinical trials are necessary to prove the ability for treatment.

01 Jan 2025·UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

Development of TAR-200: A novel targeted releasing system designed to provide sustained delivery of gemcitabine for patients with bladder cancer

Review

Author: Williams, Stephen B ; Catto, James W F ; Chang, Sam S ; Xylinas, Evanguelos ; Galsky, Matthew D ; Sweiti, Hussein ; Cutie, Christopher ; Shore, Neal D ; Guerrero-Ramos, Félix ; Miyake, Makito ; Jacob, Joseph M ; Necchi, Andrea ; Daneshmand, Siamak ; van der Heijden, Michiel S ; Kamat, Ashish M ; Meeks, Joshua J ; Daniel, Karen ; Powles, Thomas ; Simone, Giuseppe ; Psutka, Sarah P

Treatment options for recurrent high-risk non-muscle-invasive bladder cancer (HR NMIBC) and muscle-invasive bladder cancer (MIBC) are limited, highlighting a need for clinically effective, accessible, and better-tolerated alternatives. In this review we examine the clinical development program of TAR-200, a novel targeted releasing system designed to provide sustained intravesical delivery of gemcitabine to address the needs of patients with NMIBC and of those with MIBC. We describe the concept and design of TAR-200 and the clinical development of this gemcitabine intravesical system in the SunRISe portfolio of studies. This includes 3 phase I studies evaluating the safety and initial tumor activity of TAR-200 and 5 phase II/III studies assessing the efficacy and safety of TAR-200, with or without systemic cetrelimab, as a treatment option for patients with HR NMIBC (bacillus Calmette-Guérin naive [papillary and carcinoma in situ] and MIBC (neoadjuvant and patients ineligible for or refusing radical cystectomy). Pharmacokinetics demonstrate intravesical gemcitabine delivery via TAR-200 over a prolonged period without detectable plasma levels. Phase I studies showed that TAR-200 is well tolerated, with preliminary antitumor activity in intermediate-risk NMIBC and MIBC. Preliminary data from the phase IIb SunRISe-1 study demonstrate that TAR-200 monotherapy is safe and effective in patients with bacillus Calmette-Guérin-unresponsive high-risk NMIBC. TAR-200 represents an innovative approach to the local treatment of bladder cancer.

31 Dec 2024·Hematology

Phase II study of pegaspargase, etoposide, gemcitabine (PEG) followed by involved-field radiation therapy in early-stage extranodal natural killer/T-cell lymphoma

Article

Author: Feng, Demei ; Bai, Shenrui ; Yan, Zhimin ; Gale, Robert Peter ; Liang, Yang ; Zhu, Lewei ; Fu, Bibo ; Xia, Zhongjun ; Wang, Hua

OBJECTIVE:

The prognosis of extra-nodal NK/T cell lymphoma (ENKTL) is poor, and the optimal therapy remains controversial. This study aims to evaluate the safety and efficacy of a new combined modality therapy.

METHODS:

Phase-2 study of pegaspargase, etoposide and gemcitabine (PEG) combined with involved field radiation therapy (IFRT) in newly-diagnosed patients with early-stage ENKTL. Patients received 4 course of PEG followed by IFRT. The primary endpoints were complete response (CR), partial response (PR), and objective response rate (ORR) after IFRT. Secondary endpoints included progression-free survival (PFS), overall survival (OS) and adverse events.

RESULTS:

34 consecutive patients with Ann Arbor stage I/II were enrolled. 3 patients progressed on PEG, while the remaining 31 received IFRT. The ORR was 88.2% (30/34), included 28 (82.4%) complete and 2 (5.8%) partial responses. With a median follow-up of 56.0 months (Interquartile Range [IQR], 36.0-66.9 months), the estimated 5-year PFS and OS were 87.4% (95% Confidence Interval [CI],69.5%-94.8%) and 97.1% (95%CI, 80.1%-99.6%), respectively. Most adverse events were hematological and easily managed.

CONCLUSIONS:

PEG followed by IFRT is a safe and effective initial therapy for early-stage ENKTL, demonstrating impressive PFS and OS rates. This promising approach warrants further validation in a randomized controlled trial (Registered at Clinicaltrials.gov NCT02705508).Trial registration: ClinicalTrials.gov identifier: NCT02705508.

208

News (Medical) associated with Gemcitabine Hydrochloride

22 Jan 2025

·www.investor.jnj.com

Johnson & Johnson Reports Q4 and Full-Year 2024 Results

2024 Fourth-Quarter reported sales growth of 5.3% to $22.5 Billion with operational growth of 6.7%* and adjusted operational growth of 5.7%* 2024 Fourth-Quarter Earnings per share (EPS) of $1.41 and Adjusted EPS of $2.04, both include $(0.22) due to acquired IPR&D charges related to V-Wave acquisition 2024 Full-Year reported sales growth of 4.3% to $88.8 Billion with operational growth of 5.9%* and adjusted operational growth of 5.4%*. Operational growth excluding COVID-19 Vaccine of 7.0%* 2024 Full-Year Earnings per share (EPS) of $5.79 and Adjusted EPS of $9.98, both include $(0.67) due to acquired IPR&D charges on various transactions throughout the year Significant pipeline progress including RYBREVANT + LAZCLUZE overall survival data, initiation of TAR-200 submission, and approval of investigational device exemption for our general surgery robotic system, OTTAVA Company issues guidance for 2025 with operational sales5 growth of 2.5% - 3.5%* and adjusted operational EPS of $10.75 - $10.95, reflecting strong growth of 8.7%* at the mid-point NEW BRUNSWICK, N.J.--(BUSINESS WIRE)-- Johnson & Johnson (NYSE: JNJ) today announced results for fourth-quarter and full year 2024. "2024 was a transformative year for Johnson & Johnson, marked by strong growth, an accelerating pipeline and industry-leading investments in innovation,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “As a healthcare company, with a disease-centric approach, we are improving the standard of care in a broad range of diseases with high unmet need, including multiple myeloma, lung cancer, inflammatory bowel disease, and heart failure. With our strong financial foundation, differentiated portfolio and robust pipeline, we are well positioned to sustain the high pace of growth and innovation that is the hallmark of Johnson & Johnson.” Unless otherwise noted, the financial results and earnings guidance included below reflect the continuing operations of Johnson & Johnson. Overall financial results Q4 Full Year ($ in Millions, expect EPS) 2024 2023 % Change 2024 2023 % Change Reported Sales $22,520 $ 21,395 5.3% $88,821 $ 85,159 4.3% Net Earnings $3,431 $4,132 (17.0)% $14,066 $13,326 5.6% EPS (diluted) $1.41 $1.70 (17.1)% $5.79 $5.20 11.3% Q4 Full Year Non-GAAP* ($ in Millions, except EPS) 2024 2023 % Change 2024 2023 % Change Operational Sales1,2 6.7% 5.9% Adjusted Operational Sales1,3 5.7% 5.4% Adjusted Operational Sales1,3 ex. COVID-19 Vaccine 5.9% 6.5% Adjusted Net Earnings1,4 $4,946 $5,562 (11.1)% $ 24,242 $ 25,409 (4.6)% Adjusted EPS (diluted)1,4 $2.04 $2.29 (10.9)% $9.98 $9.92 0.6% Free Cash Flow6,7 ~$19,800 $18,248 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine 6 Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings. 7 Full year 2024 is estimated as of January 22, 2025. Full year 2023 includes approximately 8 months contribution from the Consumer Health segment. Note: values may have been rounded Regional sales results Q4 % Change ($ in Millions) 2024 2023 Reported Operational1,2 Currency Adjusted Operational1,3 U.S. $13,204 $12,009 10.0% 10.0 - 8.6 International 9,316 9,386 (0.7) 2.5 (3.2) 2.0 Worldwide $22,520 $21,395 5.3% 6.7 (1.4) 5.7 Full Year % Change ($ in Millions) 2024 2023 Reported Operational1,2 Currency Adjusted Operational1,3 U.S. $50,302 $46,444 8.3% 8.3 - 7.6 International 38,519 38,715 (0.5) 2.9 (3.4) 2.7 Worldwide $88,821 $85,159 4.3% 5.9 (1.6) 5.4 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Note: values may have been rounded Segment sales results Q4 % Change ($ in Millions) 2024 2023 Reported Operational1,2 Currency Adjusted Operational1,3 Innovative Medicine $14,332 $13,722 4.4% 6.1 (1.7) 6.3 MedTech 8,188 7,673 6.7 7.6 (0.9) 4.6 Worldwide $22,520 $21,395 5.3% 6.7 (1.4) 5.7 Full Year % Change ($ in Millions) 2024 2023 Reported Operational1,2 Currency Adjusted Operational1,3 Innovative Medicine $56,964 $54,759 4.0% 5.7 (1.7) 5.8 MedTech 31,857 30,400 4.8 6.2 (1.4) 4.7 Worldwide $88,821 $85,159 4.3% 5.9 (1.6) 5.4 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Note: values may have been rounded Full year 2024 segment commentary: Operational sales* reflected below excludes the impact of translational currency. Innovative Medicine Innovative Medicine worldwide operational sales, excluding the COVID-19 Vaccine, grew 7.5%*. Growth was driven primarily by DARZALEX (daratumumab), ERLEADA (apalutamide), CARVYKTI (ciltacabtagene autoleucel), and Other Oncology in Oncology, TREMFYA (guselkumab) in Immunology, and SPRAVATO (esketamine) in Neuroscience. Growth was partially offset by STELARA (ustekinumab) in Immunology and Other Neuroscience in Neuroscience. Including the COVID-19 Vaccine, Innovative Medicine worldwide operational sales grew 5.7%*. MedTech MedTech worldwide operational sales grew 6.2%*, with net acquisitions and divestitures positively impacting growth by 1.5%. Growth was driven primarily by electrophysiology products and Abiomed in Cardiovascular, previously referred to as Interventional Solutions, and wound closure products in General Surgery. Full-year 2025 guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) January 2025 Adjusted Operational Sales1,2,5 Change vs. Prior Year / Mid-point 2.0% – 3.0% / 2.5% Operational Sales2,5 / Mid-point Change vs. Prior Year / Mid-point $90.9B – $91.7B / $91.3B 2.5% – 3.5% / 3.0% Estimated Reported Sales3,5 / Mid-point Change vs. Prior Year / Mid-point $89.2B – $90.0B / $89.6B 0.5% – 1.5% / 1.0% Adjusted Operational EPS (Diluted)2,4 / Mid-point Change vs. Prior Year / Mid-point $10.75 – $10.95 / $10.85 7.7% – 9.7% / 8.7% Adjusted EPS (Diluted)3,4 / Mid-point Change vs. Prior Year / Mid-point $10.50 – $10.70 / $10.60 5.2% – 7.2% / 6.2% 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: January 2025 = $1.04 (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 News Releases, as well as Innovative Medicine News Center, MedTech News & Events, and www.factsabouttalc.com. Regulatory SPRAVATO (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression1 Press Release European Commission approves LAZCLUZE (lazertinib) in combination with RYBREVANT (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer1 Press Release New Drug Application initiated with U.S. FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer1 Press Release Johnson & Johnson MedTech Announces CE Mark Approval for Dual Energy THERMOCOOL SMARTTOUCH SF Catheter1 Press Release Nipocalimab granted U.S. FDA Priority Review for the treatment of generalized myasthenia gravis1 Press Release Johnson & Johnson's Posdinemab and Tau Active Immunotherapy Receive U.S. FDA Fast Track Designations for the Treatment of Alzheimer's Disease1 Press Release European Commission approves RYBREVANT (amivantamab) in combination with LAZCLUZE (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer Press Release Johnson & Johnson submits application to the European Medicines Agency seeking approval of a new indication for IMBRUVICA (ibrutinib) in adult patients with previously untreated mantle cell lymphoma (MCL) who are eligible for autologous stem cell transplant Press Release U.S. FDA Expands Indication for Impella Heart Pumps to Treat Pediatric Patients Press Release Johnson & Johnson seeks U.S. FDA approval for first pediatric indications for TREMFYA (guselkumab) Press Release Johnson & Johnson seeks U.S. FDA approval for subcutaneous induction regimen of TREMFYA (guselkumab) in ulcerative colitis, a first for an IL-23 inhibitor Press Release Johnson & Johnson MedTech Receives IDE Approval for OTTAVA Robotic Surgical System Press Release Nipocalimab is the first and only investigational therapy granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease Press Release Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO / DARZALEX as subcutaneous monotherapy for high-risk smoldering multiple myeloma Press Release DARZALEX (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible Press Release Data Releases RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) show statistically significant and clinically meaningful improvement in overall survival versus osimertinib1 Press Release Johnson & Johnson to showcase strength of its broad hematology portfolio and pipeline at the 2024 American Society of Hematology Annual Meeting Press Release Icotrokinra delivered an industry-leading combination of significant skin clearance with demonstrated tolerability in a once daily pill in Phase 3 topline results Press Release Johnson & Johnson advances leadership in rheumatic disease innovation with 43 abstracts at ACR 2024 Press Release Shockwave Medical Unveils First Clinical Outcomes of New IVL Platform in Late-Breaking Presentation at VIVA 2024 Press Release TREMFYA (guselkumab) is the first and only IL-23 inhibitor to demonstrate robust results with a fully subcutaneous regimen in both induction and maintenance in Crohn's disease Press Release New SPECTREM study findings reveal TREMFYA (guselkumab) effectively clears overlooked and undertreated plaque psoriasis Press Release Johnson & Johnson highlights innovative neuropsychiatry portfolio and pipeline at Psych Congress Press Release Nipocalimab demonstrates sustained disease control in adolescents living with generalized myasthenia gravis in Phase 2/3 study Press Release Product Launch MENTOR MemoryGel Enhance Breast Implant Receives FDA Approval for Largest Size Breast Implants for Reconstruction Press Release Johnson & Johnson MedTech Receives FDA Approval for the VARIPULSE Pulsed Field Ablation Platform for the Treatment of Atrial Fibrillation2 Press Release Other Johnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc.1 Press Release 1 Subsequent to the quarter 2 On January 5, 2025, Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and all U.S. VARIPULSE cases. More information can be found in the Statement on VARIPULSE. Webcast information: Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:00 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; 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; increased scrutiny of the health care industry by government agencies; and the Company’s ability to realize the anticipated benefits from the separation of Kenvue Inc. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, 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 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. 2024 2023 Total Operations Currency 2024 2023 $ 8,977 8,079 11.1 % 11.1 - $ 33,970 31,169 9.0 % 9.0 - 5,355 5,643 (5.1 ) (1.0 ) (4.1 ) 22,994 23,590 (2.5 ) 1.3 (3.8 ) 14,332 13,722 4.4 6.1 (1.7 ) 56,964 54,759 4.0 5.7 (1.7 ) 8,977 8,079 11.1 11.1 - 33,970 31,169 9.0 9.0 - 5,355 5,599 (4.4 ) (0.3 ) (4.1 ) 22,796 22,473 1.4 5.5 (4.1 ) 14,332 13,678 4.8 6.5 (1.7 ) 56,766 53,642 5.8 7.5 (1.7 ) 4,227 3,930 7.6 7.6 - 16,332 15,275 6.9 6.9 - 3,961 3,743 5.8 7.6 (1.8 ) 15,525 15,125 2.6 5.4 (2.8 ) 8,188 7,673 6.7 7.6 (0.9 ) 31,857 30,400 4.8 6.2 (1.4 ) 13,204 12,009 10.0 10.0 - 50,302 46,444 8.3 8.3 - 9,316 9,386 (0.7 ) 2.5 (3.2 ) 38,519 38,715 (0.5 ) 2.9 (3.4 ) 22,520 21,395 5.3 6.7 (1.4 ) 88,821 85,159 4.3 5.9 (1.6 ) 13,204 12,009 10.0 10.0 - 50,302 46,444 8.3 8.3 - 9,316 9,342 (0.3 ) 2.9 (3.2 ) 38,321 37,598 1.9 5.5 (3.6 ) $ 22,520 21,351 5.5 % 6.9 (1.4 ) $ 88,623 84,042 5.5 % 7.0 (1.5 ) FOURTH QUARTER TWELVE MONTHS Percent Change Percent Change 2024 2023 Total Operations Currency 2024 2023 Total Operations Currency $ 13,204 12,009 10.0 % 10.0 - $ 50,302 46,444 8.3 % 8.3 - 4,921 4,962 (0.8 ) (0.2 ) (0.6 ) 20,212 20,410 (1.0 ) (0.6 ) (0.4 ) 1,135 1,166 (2.7 ) 17.6 (20.3 ) 4,714 4,549 3.6 20.4 (16.8 ) 3,260 3,258 0.1 0.9 (0.8 ) 13,593 13,756 (1.2 ) 2.3 (3.5 ) 9,316 9,386 (0.7 ) 2.5 (3.2 ) 38,519 38,715 (0.5 ) 2.9 (3.4 ) $ 22,520 21,395 5.3 % 6.7 (1.4 ) $ 88,821 85,159 4.3 % 5.9 (1.6 ) FOURTH QUARTER TWELVE MONTHS Percent Change Percent Change 2024 2023 Total Operations Currency 2024 2023 Total Operations Currency $ 13,204 12,009 10.0 % 10.0 - $ 50,302 46,444 8.3 % 8.3 - 4,921 4,918 0.1 0.7 (0.6 ) 20,014 19,293 3.7 4.1 (0.4 ) 1,135 1,166 (2.7 ) 17.6 (20.3 ) 4,714 4,549 3.6 20.4 (16.8 ) 3,260 3,258 0.1 0.9 (0.8 ) 13,593 13,756 (1.2 ) 2.3 (3.5 ) 9,316 9,342 (0.3 ) 2.9 (3.2 ) 38,321 37,598 1.9 5.5 (3.6 ) $ 22,520 21,351 5.5 % 6.9 (1.4 ) $ 88,623 84,042 5.5 % 7.0 (1.5 ) 2024 2023 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 22,520 100.0 $ 21,395 100.0 5.3 7,128 31.6 6,798 31.8 4.9 15,392 68.4 14,597 68.2 5.4 6,453 28.6 5,810 27.1 11.1 5,298 23.5 4,480 20.9 18.3 17 0.1 58 0.3 (144 ) (0.6 ) (212 ) (1.0 ) (161 ) (0.7 ) (421 ) (2.0 ) 42 0.2 56 0.3 3,887 17.3 4,826 22.6 (19.5 ) 456 2.1 694 3.3 (34.3 ) $ 3,431 15.2 $ 4,132 19.3 (17.0 ) - (83 ) $ 3,431 $ 4,049 $ 1.41 $ 1.70 (17.1 ) $ - $ (0.03 ) 2,427.1 2,430.7 11.7 % 14.4 % $ 5,421 24.1 $ 6,237 29.2 (13.1 ) $ 4,946 22.0 $ 5,562 26.0 (11.1 ) $ 2.04 $ 2.29 (10.9 ) 8.8 % 10.8 % 2024 2023 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 88,821 100.0 $ 85,159 100.0 4.3 27,471 30.9 26,553 31.2 3.5 61,350 69.1 58,606 68.8 4.7 22,869 25.7 21,512 25.2 6.3 17,232 19.4 15,085 17.7 14.2 211 0.2 313 0.4 (577 ) (0.6 ) (489 ) (0.6 ) 4,694 5.3 6,634 7.8 234 0.3 489 0.6 16,687 18.8 15,062 17.7 10.8 2,621 3.0 1,736 2.1 51.0 $ 14,066 15.8 $ 13,326 15.6 5.6 - 21,827 $ 14,066 $ 35,153 $ 5.79 $ 5.20 11.3 $ - $ 8.52 2,429.4 2,560.4 15.7 % 11.5 % $ 28,979 32.6 $ 29,811 35.0 (2.8 ) $ 24,242 27.3 $ 25,409 29.8 (4.6 ) $ 9.98 $ 9.92 0.6 16.3 % 14.8 % 2024 2023 2024 2023 $3,431 $4,132 $14,066 $13,326 (16) 166 5,450 7,152 1,171 1,148 4,526 4,532 23 10 100 663 62 139 269 798 47 88 204 311 298 237 1,226 339 (68) (435) 306 641 17 58 211 313 (80) 75 (2,135) (2,694) 61 (56) 19 28 $4,946 $5,562 $24,242 $25,409 2,427.1 2,430.7 2,429.4 2,560.4 $2.04 $2.29 $9.98 $9.92 $2.05 $9.99 1 2 3 4 4.4 % 6.7 % 5.3 % 11.1 % 7.6 % 10.0 % (5.1 )% 5.8 % (0.7 )% (1.7 ) (0.9 ) (1.4 ) - - - (4.1 ) (1.8 ) (3.2 ) 6.1 % 7.6 % 6.7 % 11.1 % 7.6 % 10.0 % (1.0 )% 7.6 % 2.5 % (3.4 ) (1.2 ) (5.1 ) (1.7 ) (1.5 ) (0.6 ) 0.2 0.4 0.2 0.1 0.8 0.3 0.3 0.0 0.1 6.3 % 4.6 % 5.7 % 11.2 % 3.3 % 8.6 % (0.7 )% 6.1 % 2.0 % 0.4 0.2 0.0 0.0 0.7 0.4 6.7 % 4.6 % 5.9 % 11.2 % 3.3 % 8.6 % 0.0 % 6.1 % 2.4 % 4.0 % 4.8 % 4.3 % 9.0 % 6.9 % 8.3 % (2.5 )% 2.6 % (0.5 )% (1.7 ) (1.4 ) (1.6 ) - - - (3.8 ) (2.8 ) (3.4 ) 5.7 % 6.2 % 5.9 % 9.0 % 6.9 % 8.3 % 1.3 % 5.4 % 2.9 % (1.9 ) (0.7 ) (2.9 ) (1.0 ) (0.8 ) (0.3 ) 0.1 0.4 0.2 0.1 0.8 0.3 0.2 0.1 0.1 5.8 % 4.7 % 5.4 % 9.1 % 4.8 % 7.6 % 1.5 % 4.7 % 2.7 % 1.8 1.1 0.0 0.0 4.2 2.6 7.6 % 4.7 % 6.5 % 9.1 % 4.8 % 7.6 % 5.7 % 4.7 % 5.3 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) FOURTH QUARTER TWELVE MONTHS % Change % Change 2024 2023 Reported Operational (1) Currency 2024 2023 Reported Operational (1) Currency $ 2,856 3,033 -5.9 % -5.9 % - $ 11,355 11,539 -1.6 % -1.6 % - 1,383 1,562 -11.5 % -6.5 % -5.0 % 6,473 6,513 -0.6 % 4.0 % -4.6 % 4,238 4,595 -7.8 % -6.1 % -1.7 % 17,828 18,052 -1.2 % 0.4 % -1.6 % 231 294 -21.4 % -21.4 % - 1,009 1,143 -11.7 % -11.7 % - 9 35 -73.3 % -73.3 % - 98 147 -33.0 % -33.0 % - 117 100 16.5 % 22.9 % -6.4 % 497 549 -9.5 % -5.0 % -4.5 % 359 429 -16.5 % -15.0 % -1.5 % 1,605 1,839 -12.8 % -11.4 % -1.4 % 262 258 1.3 % 1.3 % - 1,082 1,124 -3.8 % -3.8 % - 321 244 32.1 % 44.2 % -12.1 % 1,108 1,073 3.3 % 13.2 % -9.9 % 583 502 16.2 % 22.1 % -5.9 % 2,190 2,197 -0.3 % 4.5 % -4.8 % 1,699 1,786 -4.9 % -4.9 % - 6,720 6,966 -3.5 % -3.5 % - 650 967 -32.7 % -29.6 % -3.1 % 3,641 3,892 -6.4 % -3.3 % -3.1 % 2,349 2,753 -14.7 % -13.6 % -1.1 % 10,361 10,858 -4.6 % -3.4 % -1.2 % 654 657 -0.6 % -0.6 % - 2,443 2,147 13.7 % 13.7 % - 295 252 16.9 % 21.7 % -4.8 % 1,227 999 22.8 % 27.6 % -4.8 % 949 910 4.2 % 5.6 % -1.4 % 3,670 3,147 16.6 % 18.1 % -1.5 % 0 2 - 3 11 -74.1 % -74.1 % - 0 0 - - - 0 0 - - - 0 2 3 11 -74.1 % -74.1 % - 331 353 -6.4 % -6.4 % - 1,354 1,500 -9.8 % -9.8 % - 443 498 -11.2 % -9.8 % -1.4 % 2,042 2,918 -30.0 % -29.3 % -0.7 % 774 852 -9.2 % -8.4 % -0.8 % 3,396 4,418 -23.1 % -22.7 % -0.4 % 0 0 - - - 0 0 - - - 0 44 198 1,117 -82.4 % -82.4 % 0.0 % 0 44 198 1,117 -82.4 % -82.4 % 0.0 % 7 9 -10.1 % -10.1 % - 31 35 -10.0 % -10.0 % - 315 299 5.0 % 5.6 % -0.6 % 1,241 1,115 11.2 % 11.2 % 0.0 % 322 307 4.6 % 5.1 % -0.5 % 1,272 1,150 10.6 % 10.6 % 0.0 % 321 341 -5.8 % -5.8 % - 1,311 1,446 -9.4 % -9.4 % - 86 98 -12.9 % -8.9 % -4.0 % 401 408 -1.7 % 1.1 % -2.8 % 407 439 -7.4 % -6.5 % -0.9 % 1,712 1,854 -7.7 % -7.1 % -0.6 % 1 4 -53.1 % -53.1 % - 11 19 -41.0 % -41.0 % - 43 58 -24.2 % -22.4 % -1.8 % 203 278 -26.7 % -23.9 % -2.8 % 45 62 -26.1 % -24.4 % -1.7 % 214 297 -27.6 % -25.0 % -2.6 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) FOURTH QUARTER TWELVE MONTHS % Change % Change 2024 2023 Reported Operational (1) Currency 2024 2023 Reported Operational (1) Currency 1,148 1,022 12.3 % 12.3 % - 4,398 4,065 8.2 % 8.2 % - 628 780 -19.6 % -16.8 % -2.8 % 2,718 3,076 -11.6 % -7.8 % -3.8 % 1,775 1,801 -1.5 % -0.3 % -1.2 % 7,115 7,140 -0.4 % 1.3 % -1.7 % 33 39 -12.8 % -12.8 % - 134 230 -41.7 % -41.7 % - 125 142 -11.5 % -7.7 % -3.8 % 507 554 -8.4 % -4.1 % -4.3 % 159 180 -11.7 % -8.8 % -2.9 % 641 783 -18.1 % -15.1 % -3.0 % 796 733 8.6 % 8.6 % - 3,125 2,897 7.9 % 7.9 % - 267 278 -4.0 % -1.8 % -2.2 % 1,097 1,218 -9.9 % -7.1 % -2.8 % 1,063 1,011 5.1 % 5.7 % -0.6 % 4,222 4,115 2.6 % 3.4 % -0.8 % 269 180 50.1 % 50.1 % - 929 589 57.8 % 57.8 % - 28 26 7.1 % 12.5 % -5.4 % 148 100 48.2 % 51.2 % -3.0 % 297 206 44.6 % 45.3 % -0.7 % 1,077 689 56.4 % 56.8 % -0.4 % 49 71 -31.0 % -31.0 % - 210 349 -39.8 % -39.8 % - 206 334 -38.1 % -35.4 % -2.7 % 965 1,204 -19.8 % -15.1 % -4.7 % 255 404 -36.9 % -34.6 % -2.3 % 1,175 1,553 -24.3 % -20.7 % -3.6 % 3,019 2,285 32.2 % 32.2 % - 10,854 8,462 28.3 % 28.3 % - 2,476 2,334 6.1 % 10.6 % -4.5 % 9,926 9,199 7.9 % 12.1 % -4.2 % 5,497 4,618 19.0 % 21.3 % -2.3 % 20,781 17,661 17.7 % 19.8 % -2.1 % 304 145 - 869 469 85.2 % 85.2 % - 31 13 94 30 334 159 963 500 92.7 % 92.7 % 0.0 % 1,799 1,395 28.9 % 28.9 % - 6,588 5,277 24.8 % 24.8 % - 1,285 1,155 11.3 % 17.0 % -5.7 % 5,082 4,467 13.8 % 19.1 % -5.3 % 3,084 2,550 20.9 % 23.5 % -2.6 % 11,670 9,744 19.8 % 22.2 % -2.4 % 342 287 19.0 % 19.0 % - 1,282 1,065 20.3 % 20.3 % - 442 361 22.4 % 25.7 % -3.3 % 1,717 1,322 29.8 % 32.9 % -3.1 % 784 647 20.9 % 22.7 % -1.8 % 2,999 2,387 25.6 % 27.3 % -1.7 % 250 255 -2.0 % -2.0 % - 1,020 1,051 -3.0 % -3.0 % - 481 533 -9.6 % -6.8 % -2.8 % 2,018 2,214 -8.8 % -6.3 % -2.5 % 731 788 -7.2 % -5.2 % -2.0 % 3,038 3,264 -6.9 % -5.2 % -1.7 % 108 102 5.6 % 5.6 % - 418 334 25.3 % 25.3 % - 38 24 59.9 % 71.6 % -11.7 % 131 61 146 126 15.8 % 18.0 % -2.2 % 549 395 38.8 % 39.8 % -1.0 % 9 9 -7.3 % -7.3 % - 34 50 -32.2 % -32.2 % - 127 191 -33.6 % -30.7 % -2.9 % 597 837 -28.6 % -24.6 % -4.0 % 135 201 -32.4 % -29.6 % -2.8 % 631 887 -28.8 % -25.0 % -3.8 % 208 90 - 643 215 - 74 58 25.5 % 30.6 % -5.1 % 288 269 7.1 % 10.4 % -3.3 % 282 148 90.4 % 92.4 % -2.0 % 931 484 92.5 % 94.3 % -1.8 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) FOURTH QUARTER TWELVE MONTHS % Change % Change 2024 2023 Reported Operational (1) Currency 2024 2023 Reported Operational (1) Currency 819 733 11.6 % 11.6 % - 3,143 2,697 16.5 % 16.5 % - 274 282 -3.2 % 1.2 % -4.4 % 1,140 1,117 2.0 % 8.2 % -6.2 % 1,092 1,017 7.4 % 8.7 % -1.3 % 4,282 3,815 12.3 % 14.1 % -1.8 % 385 368 4.8 % 4.8 % - 1,520 1,292 17.7 % 17.7 % - 160 169 -5.2 % -2.5 % -2.7 % 664 681 -2.4 % 1.1 % -3.5 % 545 536 1.7 % 2.5 % -0.8 % 2,184 1,973 10.7 % 11.9 % -1.2 % 391 348 12.3 % 12.3 % - 1,511 1,326 13.9 % 13.9 % - 75 70 5.7 % 11.2 % -5.5 % 307 255 20.1 % 27.3 % -7.2 % 465 419 11.2 % 12.1 % -0.9 % 1,817 1,582 14.9 % 16.1 % -1.2 % 42 18 - 112 79 41.8 % 41.8 % - 40 45 -10.0 % -0.4 % -9.6 % 169 182 -6.9 % 8.2 % -15.1 % 82 61 32.3 % 39.3 % -7.0 % 281 260 7.9 % 18.3 % -10.4 % 805 652 23.3 % 23.3 % - 2,866 2,906 -1.4 % -1.4 % - 153 185 -17.6 % -15.1 % -2.5 % 696 765 -9.1 % -7.1 % -2.0 % 957 837 14.3 % 14.8 % -0.5 % 3,562 3,671 -3.0 % -2.6 % -0.4 % 676 525 28.5 % 28.5 % - 2,373 2,365 0.3 % 0.3 % - - - - - - - - - - - 676 525 28.5 % 28.5 % - 2,373 2,365 0.3 % 0.3 % - 130 127 1.5 % 1.5 % - 494 541 -8.8 % -8.8 % - 153 185 -17.6 % -15.1 % -2.5 % 696 765 -9.1 % -7.1 % -2.0 % 281 312 -9.8 % -8.3 % -1.5 % 1,189 1,306 -8.9 % -7.8 % -1.1 % 8,977 8,079 11.1 % 11.1 % - 33,970 31,169 9.0 % 9.0 % - 5,355 5,643 -5.1 % -1.0 % -4.1 % 22,994 23,590 -2.5 % 1.3 % -3.8 % $ 14,332 $ 13,722 4.4 % 6.1 % -1.7 % $ 56,964 54,759 4.0 % 5.7 % -1.7 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) FOURTH QUARTER TWELVE MONTHS % Change % Change 2024 2023 Reported Operational (1) Currency 2024 2023 Reported Operational (1) Currency $ 1,221 971 25.8 % 25.8 % - $ 4,513 3,633 24.2 % 24.2 % - 841 698 20.6 % 22.0 % -1.4 % 3,194 2,717 17.6 % 20.9 % -3.3 % 2,062 1,669 23.6 % 24.2 % -0.6 % 7,707 6,350 21.4 % 22.8 % -1.4 % 681 667 2.1 % 2.1 % - 2,738 2,458 11.4 % 11.4 % - 640 572 11.7 % 13.3 % -1.6 % 2,529 2,230 13.4 % 17.0 % -3.6 % 1,321 1,239 6.6 % 7.3 % -0.7 % 5,267 4,688 12.3 % 14.0 % -1.7 % 308 276 11.3 % 11.3 % - 1,213 1,066 13.7 % 13.7 % - 77 64 19.8 % 21.1 % -1.3 % 284 240 18.2 % 20.3 % -2.1 % 384 340 12.9 % 13.2 % -0.3 % 1,496 1,306 14.5 % 14.9 % -0.4 % 202 - - 442 - - 56 - - 122 - - 258 - - 564 - - 31 28 11.1 % 11.1 % - 120 109 10.7 % 10.7 % - 68 61 12.1 % 12.3 % -0.2 % 260 247 5.3 % 7.3 % -2.0 % 99 89 11.8 % 12.0 % -0.2 % 380 356 6.9 % 8.4 % -1.5 % 1,460 1,425 2.4 % 2.4 % - 5,689 5,525 3.0 % 3.0 % - 856 843 1.6 % 2.5 % -0.9 % 3,470 3,417 1.5 % 3.0 % -1.5 % 2,315 2,268 2.1 % 2.5 % -0.4 % 9,158 8,942 2.4 % 3.0 % -0.6 % 272 266 2.5 % 2.5 % - 1,057 996 6.2 % 6.2 % - 146 132 10.6 % 11.7 % -1.1 % 581 564 3.0 % 4.6 % -1.6 % 418 398 5.2 % 5.6 % -0.4 % 1,638 1,560 5.0 % 5.6 % -0.6 % 238 242 -1.5 % -1.5 % - 922 896 2.9 % 2.9 % - 160 144 10.7 % 11.3 % -0.6 % 623 559 11.3 % 12.4 % -1.1 % 398 387 3.1 % 3.3 % -0.2 % 1,545 1,456 6.1 % 6.5 % -0.4 % 514 487 5.5 % 5.5 % - 2,013 1,949 3.3 % 3.3 % - 250 255 -1.9 % -0.5 % -1.4 % 1,036 1,030 0.6 % 2.1 % -1.5 % 764 741 3.0 % 3.5 % -0.5 % 3,049 2,979 2.3 % 2.9 % -0.6 % 434 430 1.1 % 1.1 % - 1,696 1,684 0.7 % 0.7 % - 300 311 -3.6 % -2.9 % -0.7 % 1,230 1,263 -2.6 % -1.2 % -1.4 % 735 742 -0.9 % -0.6 % -0.3 % 2,926 2,947 -0.7 % -0.1 % -0.6 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) FOURTH QUARTER TWELVE MONTHS % Change % Change 2024 2023 Reported Operational (1) Currency 2024 2023 Reported Operational (1) Currency 1,038 1,047 -0.9 % -0.9 % - 4,003 4,031 -0.7 % -0.7 % - 1,469 1,484 -1.0 % 1.4 % -2.4 % 5,842 6,006 -2.7 % 0.6 % -3.3 % 2,507 2,530 -0.9 % 0.4 % -1.3 % 9,845 10,037 -1.9 % 0.1 % -2.0 % 478 468 2.0 % 2.0 % - 1,838 1,833 0.2 % 0.2 % - 673 698 -3.6 % -1.6 % -2.0 % 2,650 2,837 -6.6 % -3.5 % -3.1 % 1,151 1,167 -1.4 % -0.1 % -1.3 % 4,488 4,671 -3.9 % -2.0 % -1.9 % 560 579 -3.1 % -3.1 % - 2,165 2,198 -1.5 % -1.5 % - 795 785 1.4 % 4.0 % -2.6 % 3,192 3,168 0.8 % 4.3 % -3.5 % 1,357 1,364 -0.5 % 1.0 % -1.5 % 5,358 5,366 -0.2 % 2.0 % -2.2 % 509 487 4.5 % 4.5 % - 2,128 2,086 2.0 % 2.0 % - 794 721 10.2 % 12.2 % -2.0 % 3,018 2,986 1.1 % 3.7 % -2.6 % 1,303 1,208 7.9 % 9.1 % -1.2 % 5,146 5,072 1.5 % 3.0 % -1.5 % 396 374 6.0 % 6.0 % - 1,684 1,626 3.6 % 3.6 % - 541 508 6.4 % 8.5 % -2.1 % 2,049 2,076 -1.3 % 1.8 % -3.1 % 937 882 6.3 % 7.4 % -1.1 % 3,733 3,702 0.8 % 2.6 % -1.8 % 113 114 -0.4 % -0.4 % - 444 460 -3.4 % -3.4 % - 252 212 19.3 % 21.1 % -1.8 % 969 910 6.5 % 8.2 % -1.7 % 365 326 12.4 % 13.6 % -1.2 % 1,413 1,370 3.2 % 4.3 % -1.1 % 4,227 3,930 7.6 % 7.6 % - 16,332 15,275 6.9 % 6.9 % - 3,961 3,743 5.8 % 7.6 % -1.8 % 15,525 15,125 2.6 % 5.4 % -2.8 % $ 8,188 $ 7,673 6.7 % 7.6 % -0.9 % $ 31,857 30,400 4.8 % 6.2 % -1.4 % FOURTH QUARTER TWELVE MONTHS Percent Change Percent Change 2024 2023 Total Operations Currency 2024 2023 Total Operations Currency $ 8,977 8,079 11.1 11.1 - $ 33,970 31,169 9.0 9.0 - 5,355 5,643 (5.1 ) (1.0 ) (4.1 ) 22,994 23,590 (2.5 ) 1.3 (3.8 ) 14,332 13,722 4.4 6.1 (1.7 ) 56,964 54,759 4.0 5.7 (1.7 ) - - - - - - - - - - - 44 198 1,117 (82.4 ) (82.4 ) 0.0 - 44 198 1,117 (82.4 ) (82.4 ) 0.0 8,977 8,079 11.1 11.1 - 33,970 31,169 9.0 9.0 - 5,355 5,599 (4.4 ) (0.3 ) (4.1 ) 22,796 22,473 1.4 5.5 (4.1 ) 14,332 13,678 4.8 6.5 (1.7 ) 56,766 53,642 5.8 7.5 (1.7 ) 13,204 12,009 10.0 10.0 - 50,302 46,444 8.3 8.3 - 9,316 9,386 (0.7 ) 2.5 (3.2 ) 38,519 38,715 (0.5 ) 2.9 (3.4 ) 22,520 21,395 5.3 6.7 (1.4 ) 88,821 85,159 4.3 5.9 (1.6 ) - - - - - - - - - - - 44 * * * 198 1,117 (82.4 ) (82.4 ) 0.0 - 44 * * * 198 1,117 (82.4 ) (82.4 ) 0.0 13,204 12,009 10.0 10.0 - 50,302 46,444 8.3 8.3 - 9,316 9,342 (0.3 ) 2.9 (3.2 ) 38,321 37,598 1.9 5.5 (3.6 ) $ 22,520 21,351 5.5 6.9 (1.4 ) $ 88,623 84,042 5.5 7.0 (1.5 ) $ 4,921 4,962 (0.8 ) (0.2 ) (0.6 ) $ 20,212 20,410 (1.0 ) (0.6 ) (0.4 ) - 44 * * * 198 1,117 (82.4 ) (82.4 ) 0.0 $ 4,921 4,918 0.1 0.7 (0.6 ) $ 20,014 19,293 3.7 4.1 (0.4 ) Innovative Medicine MedTech Unallocated Worldwide Total 2024 2023 2024 2023 2024 2023 2024 2023 4,009 4,238 72 404 (194 ) 184 3,887 4,826 28.0 % 30.9 % 0.9 % 5.3 % -0.9 % 0.9 % 17.3 % 22.6 % 685 747 486 401 - - 1,171 1,148 17 - - 58 - - 17 58 (41 ) 17 (29 ) 149 54 - (16 ) 166 (50 ) (112 ) (18 ) (59 ) - (264 ) (68 ) (435 ) 2 55 60 84 - - 62 139 12 175 268 62 18 - 298 237 - - 47 88 - - 47 88 23 10 - - - - 23 10 4,657 5,130 886 1,187 (122 ) (80 ) 5,421 6,237 32.5 % 37.4 % 10.8 % 15.5 % -0.5 % -0.4 % 24.1 % 29.2 % 3,698 3,357 1,600 1,123 5,298 4,480 25.8 % 24.5 % 19.5 % 14.6 % 23.5 % 20.9 % 390 390 540 540 540 390 540 390 Innovative Medicine MedTech Unallocated Worldwide Total 2024 2023 2024 2023 2024 2023 2024 2023 18,919 18,246 3,740 4,669 (5,972 ) (7,853 ) 16,687 15,062 33.2 % 33.3 % 11.7 % 15.4 % -6.7 % -9.2 % 18.8 % 17.7 % 2,772 2,983 1,754 1,549 - - 4,526 4,532 211 206 - 107 - - 211 313 358 (108 ) (14 ) 190 5,106 7,070 5,450 7,152 (76 ) 362 30 (102 ) 352 381 306 641 102 479 167 319 - - 269 798 66 175 1,015 164 145 - 1,226 339 - - 204 311 - - 204 311 100 663 - - - - 100 663 22,452 23,006 6,896 7,207 (369 ) (402 ) 28,979 29,811 39.4 % 42.0 % 21.6 % 23.7 % -0.4 % -0.5 % 32.6 % 35.0 % 13,529 11,963 3,703 3,122 17,232 15,085 23.8 % 21.8 % 11.6 % 10.3 % 19.4 % 17.7 % 390 390 1,250 1,250 540 540 1,250 540 390 1,790 390 $ 7,128 (1,162 ) (20 ) (153 ) (18 ) - - 5,775 6,453 (4 ) 6,449 5,298 - (25 ) (6 ) 5,267 (161 ) (9 ) 16 - (145 ) 68 (17 ) (248 ) 17 (17 ) - - 42 (42 ) - 456 171 (158 ) 4 3 80 (34 ) 9 5 (61 ) 475 3,431 1,000 142 13 59 218 (34 ) 38 18 61 4,946 $ 6,798 (1,131 ) (83 ) (42 ) (12 ) - 5,530 5,810 (8 ) 5,802 4,480 (16 ) (38 ) (1 ) 4,425 (421 ) (17 ) (166 ) - (221 ) 435 3 (387 ) 58 (58 ) - 56 (56 ) - 694 175 (134 ) 13 16 30 (191 ) 16 - 56 675 4,132 973 300 45 123 207 (244 ) 72 10 (56 ) 5,562 $ 27,471 (4,517 ) (35 ) (359 ) (84 ) (8 ) 22,468 22,869 (16 ) - 22,853 17,232 (69 ) (104 ) (25 ) 17,034 4,694 (9 ) (5,450 ) - (798 ) (306 ) (67 ) (1,936 ) 211 (211 ) - - - - - 234 (234 ) - 2,621 644 1,066 47 45 302 (29 ) 38 22 (19 ) 4,737 14,066 3,882 4,384 164 224 924 335 166 78 19 24,242 $ 26,553 (4,511 ) (309 ) (133 ) (189 ) 21,411 21,512 (29 ) 21,483 15,085 (32 ) (149 ) (99 ) 14,805 6,634 (21 ) (7,152 ) - (307 ) (641 ) (375 ) (1,862 ) 313 (313 ) - - 489 (489 ) - 1,736 707 1,505 70 157 52 (9 ) 57 155 (28 ) 4,402 13,326 3,825 5,647 243 641 287 650 254 508 28 25,409 Media contact: media-relations@its.jnj.com Investor contact: investor-relations@its.jnj.com

Drug ApprovalClinical ResultVaccineImmunotherapyFinancial Statement

15 Jan 2025

·www.prnewswire.com

New Drug Application initiated with U.S. FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer

Application accepted for U.S. FDA Real-Time Oncology Review (RTOR) based on Phase 2b SunRISe-1 study showing highest single-agent complete response rate of 83.5 percent1 RARITAN, N.J., Jan. 15, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced it has initiated the submission of an original New Drug Application with the U.S. Food and Drug Administration (FDA) for TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. This submission is being reviewed by the FDA through the Real-Time Oncology Review (RTOR) program, which allows the FDA to review data before the complete application is formally submitted and helps ensure treatments are available for patients as soon as possible. "Upon approval, TAR-200 promises to be a meaningful additional treatment option for certain patients with NMIBC, addressing a critical need for people who have had relatively limited therapeutic alternatives. Many patients face life-altering surgical options such as radical cystectomy, which is complete bladder removal," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Innovative Medicine. "By combining our expertise in innovative medicine and medical devices, Johnson & Johnson is uniquely positioned to transform how we treat certain types of bladder cancer through the first and only intravesical drug releasing system for this disease. We look forward to working with the FDA in review of this application." The submission of this innovative intravesical drug releasing system is supported by data from the Phase 2b SunRISe-1 registration study. Data collected through the second quarter of 2024 and presented at the European Society for Medical Oncology (ESMO) 2024 Congress as a late-breaking oral presentation showed an 83.5 percent complete response (CR) rate and highly durable CRs without the need for reinduction – at a median follow-up of nine months, 82 percent of responders maintained response. At data cutoff in May 2024, safety and tolerability data presented at ESMO demonstrated a low occurrence of Grade 3 or higher treatment-related adverse events (TRAEs) (9 percent); five patients had TRAEs leading to discontinuation (6 percent) and no treatment-related deaths were reported.1 TAR-200 is an investigational intravesical drug releasing system designed to provide sustained local delivery of gemcitabine into the bladder. It is placed into the bladder by a healthcare professional using a co-packaged urinary placement catheter in an outpatient setting in under five minutes and without the need for anesthesia. In December 2023, the FDA granted Breakthrough Therapy Designation (BTD) to TAR-200 for the treatment of adult patients with BCG-unresponsive HR-NMIBC with CIS who are ineligible for or have elected not to undergo radical cystectomy. About SunRISe-1, Cohort 2 SunRISe-1 (NCT04640623), Cohort 2, is a randomized, parallel-assignment, open-label Phase 2b clinical study evaluating the safety and efficacy of TAR-200 monotherapy alone for BCG-unresponsive HR-NMIBC carcinoma in situ (CIS) patients who are ineligible for, or elected not to undergo, radical cystectomy. The primary endpoint for Cohort 2 is CR rate at any time point. Secondary endpoints include duration of response (DOR), overall survival (OS), pharmacokinetics, quality of life, safety and tolerability. About High-Risk Non-Muscle-Invasive Bladder Cancer High-risk non-muscle-invasive bladder cancer (HR-NMIBC) is a type of non-invasive bladder cancer that is more likely to recur or spread beyond the lining of the bladder, called the urothelium, and progress to invasive bladder cancer compared to low-risk NMIBC.2, 3 HR-NMIBC makes up 15-44 percent of patients with NMIBC and is characterized by a high-grade, large tumor size, presence of multiple tumors, and CIS. Radical cystectomy is currently recommended for NMIBC patients who fail BCG therapy, with over 90 percent cancer-specific survival if performed before muscle-invasive progression.4, 5 Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.6 The high rates of recurrence and progression can pose significant morbidity and distress for these patients.2, 5 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. Janssen Research & Development, LLC, and Janssen Biotech, Inc., are Johnson & Johnson companies. 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 TAR-200. 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 Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC and/or 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 healthcare products and services; changes to applicable laws and regulations, including global healthcare reforms; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, 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. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC nor Johnson & Johnson undertakes 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

Phase 2Clinical ResultBreakthrough Therapy

15 Jan 2025

·endpts.com

Hinge Bio's $30M raise; Keros reports additional issues in Phase 2 PAH trial

Plus, news about Inflammasome Therapeutics, Johnson & Johnson and Verastem: Autoimmune disease startup nabs $30M: Hinge Bio de-stealthed with a Series A on Wednesday, led by hedge fund titan Steve Cohen’s firm Point72. The round will help get Hinge’s lead program, HB2198, into a Phase 1 trial for lupus. HB2198 is designed to target both CD19 and CD20 and “reset” the immune system by depleting B cells. — Max Gelman Keros halts all dosing in Phase 2 trial: The company said it voluntarily stopped giving patients cibotercept (KER-012) to all patients in the trial after seeing additional heart-related side effects. Keros previously halted two of three dosing arms last month in the pulmonary arterial hypertension study. Keros stock $KROS fell 20% premarket. — Max Gelman Eye disease biotech toplines five-patient dataset: Inflammasome said its treatment for geographic atrophy reduced lesion growth by an average of 66% after three months. Patients received an injection into the eye of the program, called a K8 implant. Researchers intend to give patients a second injection after three months and will expand the trial to 30 patients. — Max Gelman Johnson & Johnson files bladder cancer drug device in the US : The pharma is seeking approval of TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The product uses a silicone tube to deliver gemcitabine directly to the bladder. One of its pivotal trials yielded a complete response rate of 83.5%, but the other was stopped early after an interim look showed TAR-200 was no better than chemo. — Elizabeth Cairns Verastem licenses GenFleet’s oral KRAS inhibitor for $5M upfront : VS-7375 is a selective KRAS G12D (ON/OFF) inhibitor in Phase 1 trials in China in advanced KRAS G12D-mutant solid tumors. Verastem will get rights outside China , Hong Kong, Macau and Taiwan, and plans to start a US Phase 1/2a trial in mid-2025. The US biotech will provide $1.5 million of research support over the first three years, and milestone and option payments could total $620 million, according to a filing , with royalties on top. — Elizabeth Cairns

Phase 2Phase 1Clinical ResultPROTACs

100 Deals associated with Gemcitabine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01155	Gemcitabine Hydrochloride	L01BC05	DB00441

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bladder Cancer	AU	Sandoz Pty Ltd.	02 Dec 2008
Locally Advanced Lung Non-Small Cell Carcinoma	AU	Sandoz Pty Ltd.	02 Dec 2008
Locally Advanced Pancreatic Adenocarcinoma	AU	Sandoz Pty Ltd.	02 Dec 2008
metastatic non-small cell lung cancer	AU	Sandoz Pty Ltd.	02 Dec 2008
Pancreatic adenocarcinoma metastatic	AU	Sandoz Pty Ltd.	02 Dec 2008
Recurrent ovarian cancer	AU	Sandoz Pty Ltd.	02 Dec 2008
Transitional Cell Carcinoma	JP	Eli Lilly & Co.	25 Nov 2008
Biliary Tract Neoplasms	JP	Eli Lilly & Co.	31 Aug 2001
Lymphoma	JP	Eli Lilly & Co.	31 Aug 2001
Ovarian Cancer	JP	Eli Lilly & Co.	31 Aug 2001
Breast Cancer	US	Eli Lilly & Co.	15 May 1996
Metastatic breast cancer	US	Eli Lilly & Co.	15 May 1996
Non-Small Cell Lung Cancer	US	Eli Lilly & Co.	15 May 1996
Pancreatic adenocarcinoma	US	Eli Lilly & Co.	15 May 1996
Pancreatic Cancer	US	Eli Lilly & Co.	15 May 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Muscle Invasive Bladder Neoplasms	NDA/BLA	US	Johnson & Johnson (China) Investment Ltd.	15 Jan 2025
Diffuse Large B-Cell Lymphoma	Phase 3	US	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	CN	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	AU	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	BE	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	DK	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	FR	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	DE	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	PL	Hoffmann-La Roche, Inc.	23 Feb 2021
Diffuse Large B-Cell Lymphoma	Phase 3	KR	Hoffmann-La Roche, Inc.	23 Feb 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02705508 (Pubmed \| Hematology) Manual	Phase 2	Extranodal NK-T-Cell Lymphoma First line	34	PEG (pegaspargase, etoposide, gemcitabine)	suqiencktg(muftiqzqqd) = xekllznera mfuyxehkxt (flqniofsct ) View more	Positive	31 Dec 2024
ESMO_IO2024	Not Applicable	Advanced Bile Duct Carcinoma First line CEA \| albumin \| GGT ... View more	319	gemcitabine (Low Risk Group)	kbnkpxtknk(cupfrzkxvj) = zdjreiixwz arbcamqfww (nbvgvlqzad ) View more	Positive	12 Dec 2024
				gemcitabine (Intermediate Risk Group)	kbnkpxtknk(cupfrzkxvj) = xypbcdmplu arbcamqfww (nbvgvlqzad ) View more
ESMO_ASIA2024	Not Applicable	Advanced biliary tract cancer First line CEA \| albumin \| GGT ... View more	319	gemcitabine (Low Risk Group)	ssmkfmmmea(rkxexqffbs) = mejprmxqxr axoiewfnlx (afclypwill ) View more	Positive	07 Dec 2024
				gemcitabine (Intermediate Risk Group)	ssmkfmmmea(rkxexqffbs) = tkbtyrhhbg axoiewfnlx (afclypwill ) View more
ESMO_ASIA2024	Not Applicable	Biliary Tract Neoplasms Adjuvant	302	Gemcitabine plus Capecitabine (GEMCAP)	fmjqfkavng(qjuullvorz) = tapbsvagip vkfjyqgnrc (illwkmvyfi )	Positive	07 Dec 2024
				Capecitabine (CAP)	fmjqfkavng(qjuullvorz) = nugtyqhlef vkfjyqgnrc (illwkmvyfi )
NCT02312245 (CTgov)	Phase 2	Platinum-Resistant Fallopian Tube Carcinoma \| Recurrent ovarian cancer \| Recurrent Primary Peritoneal Carcinoma	13	Paclitaxel+Bevacizumab (Arm A (Avatar-directed Paclitaxel))	hrdtvsxneg(walbuonwpp) = risaftopii kugqchdttf (sysvkoipze, ewulizbyfo - jidpltuwoc) View more	-	05 Dec 2024
				Gemcitabine Hydrochloride (Arm B (Avatar-directed Gemcitabine Hydrochloride))	hrdtvsxneg(walbuonwpp) = apblfdxgrg kugqchdttf (sysvkoipze, vwvywhidex - ycnocbibld) View more
NCT02953509 (Pubmed \| Blood Adv) Manual	Phase 1/2	Diffuse Large B-Cell Lymphoma	132	Magrolimab plrituximabmab	tsumiktakr(dhgudftxto) = tjojpivhww lbwoaltksq (qtnsbgzkvd ) View more	Positive	26 Nov 2024
				Magrolimab plrituximabmabgemcitabinetaboxaliplatinatin	tsumiktakr(dhgudftxto) = lurhwvvukc lbwoaltksq (qtnsbgzkvd ) View more
NCT02641847 (BCTOP-T-A01, Literature) Manual	Phase 3	Triple Negative Breast Cancer	498	docetaxel+doxorubicin or epirubicin+cyclophosphamide+gemcitabine+cisplatin (High risk group A)	iqxouvsfmd(phwzxsopku) = tsklkiwnni lgwboawtyv (phdvqsjirk ) View more	Positive	23 Oct 2024
				docetaxel+doxorubicin or epirubicin+cyclophosphamide (High risk group B)	iqxouvsfmd(phwzxsopku) = uvjgjyljdg lgwboawtyv (phdvqsjirk ) View more
NCT03768414 (SWOG 1815, CTgov)	Phase 3	Unresectable Intrahepatic Cholangiocarcinoma \| Advanced biliary tract cancer \| Gallbladder Neoplasms ... View more	452	Nab-paclitaxel+Gem+Cisplatin (Gem+Cisplatin+Nab-paclitaxel)	qdqlmfctim(bjdkzgfczv) = dbukelrpaa bxtqxiivdo (ohtimdirmq, yudkghpnne - doukaplexu) View more	-	22 Oct 2024
				Gemcitabine+Cisplatin (Gemcitabine + Cisplatin)	qdqlmfctim(bjdkzgfczv) = lxqmljperq bxtqxiivdo (ohtimdirmq, crqdckgkfu - riktfgortg) View more
NCT04919512 (SunRISe-4, ESMO2024) Manual	Phase 2	Muscle Invasive Bladder Carcinoma Neoadjuvant	120	TAR-200 + cetrelimab	uauchicxsi(sugchgxnsc) = jkwktovhut xekthcukxe (xuxfvsqitb, 28 - 56) View more	Positive	16 Sep 2024
				cetrelimab	uauchicxsi(sugchgxnsc) = gdhjjncimn xekthcukxe (xuxfvsqitb, 10 - 41) View more
NCT04640623 (SunRISe-1, ESMO2024) Manual	Phase 2	Non-Muscle Invasive Bladder Neoplasms PD-L1 Expression	21	TAR-200 alone	jnbybcoqrw(fabkmlaodb) = nvzxmiacxs uecjqeebje (ngtsuiyfvz, 58.7 - 99.8)	Positive	15 Sep 2024
				TAR-200 (PD-L1 CPS<10)	jnbybcoqrw(fabkmlaodb) = uskzgolxgx uecjqeebje (ngtsuiyfvz, 34.8 - 93.3)

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